id|nct_id|outcome_id|non_inferiority_type|non_inferiority_description|param_type|param_value|dispersion_type|dispersion_value|p_value_modifier|p_value|ci_n_sides|ci_percent|ci_lower_limit|ci_upper_limit|ci_upper_limit_na_comment|p_value_description|method|method_description|estimate_description|groups_description|other_analysis_description|ci_upper_limit_raw|ci_lower_limit_raw|p_value_raw
91518150|NCT01986881|182910660|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.97|||<|0.001|TWO_SIDED|95.6|0.848|1.114||Model included treatment as an explanatory factor and cohort category as a stratification factor.|Cox Proportional Hazards Model|||||1.114|0.848|<0.001
91580805|NCT02233543|183051613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2419|TWO_SIDED|95.0|-1.21|0.32|||Mixed Models Analysis|||||0.32|-1.21|0.2419
91580806|NCT02233543|183051614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.79||||0.2016|TWO_SIDED|95.0|-4.51|20.08|||Mixed Models Analysis|||||20.08|-4.51|0.2016
91580807|NCT01302067|183051615|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.16|-0.66||Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.|ANCOVA|Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.|Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.||-0.66|-1.16|<0.0001
91580808|NCT01302067|183051615|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.11||0.0109|TWO_SIDED|95.0|-0.48|-0.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.06|-0.48|0.0109
91580809|NCT01302067|183051615|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.39||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.39|-0.89|<0.0001
91580810|NCT01302067|183051616|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.48|-0.79||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.79|-1.48|<0.0001
91580811|NCT01302067|183051616|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.67|-0.1||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.10|-0.67|0.0082
91580812|NCT01302067|183051616|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.41||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.41|-1.10|<0.0001
91580813|NCT01302067|183051617|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.76|-1.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.03|-1.76|<0.0001
91769472|NCT00179621|183425932|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
91518151|NCT01986881|182910660|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|1.04||||0.002|TWO_SIDED|95.6|0.887|1.211|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.211|0.887|0.002
91580814|NCT01302067|183051617|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.83|-0.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.23|-0.83|0.0006
91518152|NCT01986881|182910660|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.6|0.773|1.065|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.065|0.773|<0.001
91518153|NCT01986881|182910662|SUPERIORITY||Difference in the Least Squares Means|-0.65|||<|0.001|TWO_SIDED|95.0|-0.78|-0.51||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|cLDA Model|||||-0.51|-0.78|<0.001
91580815|NCT01302067|183051617|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.51|-1.23|<0.0001
91613210|NCT02746679|183120716|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91613211|NCT02746679|183120717|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||||||0.024
91613212|NCT02746679|183120718|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
91769473|NCT00179621|183425932|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
91769474|NCT00179621|183425933|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
91769475|NCT00179621|183425933|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
91769476|NCT00179621|183425943|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91769477|NCT00179621|183425943|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91769478|NCT00179621|183425944|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANOVA|||||||0.054
91769479|NCT00179621|183425944|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.080
91769480|NCT00179621|183425945|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||ANOVA|||||||0.062
91769481|NCT00179621|183425945|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANOVA|||||||0.113
91769482|NCT02722564|183425947|OTHER||||||<|0.001||||||p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.|t-test, 2 sided|||||||<0.001
91769483|NCT02722564|183425947|OTHER||||||<|0.0001||||||p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.|t-test, 2 sided|||||||<0.0001
91769484|NCT00865345|183425948|SUPERIORITY_OR_OTHER||Intercept from ANCOVA model|70.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.05|TWO_SIDED|95.0|60.0|100.0|||ANCOVA|null model ANOVA is used to calculate 95% CI around accuracy rate. Intercept was fit in the abscence of other predictors.||||100|60|<0.05
91769485|NCT03692208|183425957|OTHER|Quantitative outcomes from chart and survey data were summarized by basic descriptive statistics.|||||<|0.01||||||P-values were calculated. Only P values of \<0.05 were considered statistically significant.|Chi-squared|Chi-squared tests, Fisher's Exact tests, two-sample t-tests, and paired two-sample t-tests were utilized to assess the outcomes between study arms.||||||<0.01
91769486|NCT05482308|183425984|OTHER||Mean differences(Test-Reference)|98.35|||||TWO_SIDED|90.0|92.92|104.1|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||104.10|92.92|
91769487|NCT05482308|183425985|OTHER||Mean difference (Test-Reference)|91.58|||||TWO_SIDED|90.0|81.5|102.9|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||102.90|81.50|
91769488|NCT01693029|183425988|EQUIVALENCE|"Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors treatment group and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)"|Mean Difference (Final Values)|-0.0926|||||TWO_SIDED|90.0|-0.2264|0.0413|||||||95% confidence interval for the difference is (-0.2522, 0.0670).|0.0413|-0.2264|
91769489|NCT00657540|183426006|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|The proportion of treatment failures was compared between groups using a one-sided test at the 0.025 level of significance.||||||0.0185
91769490|NCT00657540|183426007|SUPERIORITY_OR_OTHER|||||||0.2302|||||||Chi-squared|Chi-squared tests at the 0.025 level of significance were used to test for a difference in proportions between the treatment groups.||||||0.2302
91769491|NCT00657540|183426008|SUPERIORITY_OR_OTHER|||||||0.8213|||||||Chi-squared|The proportion of subjects with at least one drug-related adverse event by treatment groups using a two-sided test at the 0.05 level of significance.||||||0.8213
91769492|NCT00657540|183426009|SUPERIORITY_OR_OTHER|||||||0.2765|||||||Chi-squared|The proportion of subjects with decreased pain at any time point between treatment groups using a one-sided test at the 0.025 level of significance.||||||0.2765
91769493|NCT00141453|183426011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.79||95.0|0.75|1.24|||Regression, Cox|The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline \& regions (Japan/Hong Kong) for the renal composite event rate.||We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.||1.24|0.75|0.79
91769494|NCT00141453|183426012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.039||95.0|0.43|0.98|||Regression, Cox|Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.||||0.98|0.43|0.039
91769495|NCT02656017|183426032|SUPERIORITY||Mean Difference (Net)|0.07||||0.5|TWO_SIDED|95.0|-0.13|0.26|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GSRS score as a function of time, the interaction between time and study arm, and clinical site.||0.26|-0.13|0.50
91769496|NCT02656017|183426033|SUPERIORITY|||||||0.12|||||||Gray's test|||The Gray's test of homogeneity for competing risks was used to compare cumulative incidence of tolerating the drug between study arms.||||0.12
91769497|NCT02656017|183426034|SUPERIORITY|||||||0.98|||||||Regression, Logistic|||Cumulative incidence between study arms and logistic regression was used to assess the association between study arms.||||0.98
91769498|NCT02656017|183426035|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.72|TWO_SIDED|95.0|-1.81|2.6|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 PCS as a function of time, the interaction between time and study arm, and clinical site.||2.60|-1.81|0.72
91769499|NCT02656017|183426036|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.49|TWO_SIDED|95.0|-2.02|4.25|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 MCS as a function of time, the interaction between time and study arm, and clinical site.||4.25|-2.02|0.49
91769500|NCT02656017|183426037|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare back pain frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.44
91769501|NCT02656017|183426038|SUPERIORITY||Mean Difference (Final Values)|2.73||||0.2|TWO_SIDED|95.0|-1.4|6.87|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in eGFR as a function of time, the interaction between time and study arm, and clinical site.||6.87|-1.40|0.20
91769502|NCT02656017|183426039|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.38|TWO_SIDED|95.0|-2.11|5.62|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKV) as a function of time, the interaction between time and study arm, and clinical site.||5.62|-2.11|0.38
91769503|NCT02656017|183426040|SUPERIORITY||Mean Difference (Final Values)|3.81||||0.31|TWO_SIDED|95.0|-3.48|11.65|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKCV) as a function of time, the interaction between time and study arm, and clinical site.||11.65|-3.48|0.31
91769504|NCT02656017|183426041|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.72|TWO_SIDED|95.0|-1.78|2.61|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLV) as a function of time, the interaction between time and study arm, and clinical site.||2.61|-1.78|0.72
91769505|NCT02656017|183426042|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.8|TWO_SIDED|95.0|-10.05|14.76|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLCV) as a function of time, the interaction between time and study arm, and clinical site.||14.76|-10.05|0.80
91769506|NCT02656017|183426043|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare abdominal fullness interfered as a function of time, the interaction between time and study arm, and clinical site.||||0.83
91769507|NCT02656017|183426044|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with sleep frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.72
91769508|NCT02656017|183426045|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with strenuous physical activity frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.28
91769509|NCT04755816|183426046|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
91769510|NCT04755816|183426047|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in group A and B. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
91769511|NCT04755816|183426049|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.321|3.743||||||Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C.||3.743|0.321|
91769512|NCT04755816|183426050|OTHER|Estimates and confidence intervals are provided|Slope|-15.37|||||TWO_SIDED|95.0|-37.5|6.76|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||6.76|-37.5|
91769513|NCT04755816|183426051|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.163|1.901||||||Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B.||1.901|0.163|
91518154|NCT01986881|182910662|SUPERIORITY||Difference in the Least Squares Means|-0.58|||<|0.001|TWO_SIDED|95.0|-0.71|-0.44||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|Constrained longitudinal data analysis|||||-0.44|-0.71|<0.001
91790122|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.349
91518155|NCT01986881|182910664|SUPERIORITY||Difference in the Least Squares Means|-0.22||||0.247|TWO_SIDED|95.0|-0.6|0.16||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||0.16|-0.60|0.247
91518156|NCT01986881|182910664|SUPERIORITY||Difference in the Least Squares Means|-0.35||||0.063|TWO_SIDED|95.0|-0.72|0.02||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||0.02|-0.72|0.063
91518157|NCT01986881|182910666|SUPERIORITY||Difference in the Least Squares Means|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||-0.53|-0.98|<0.001
91518158|NCT01986881|182910666|SUPERIORITY||Difference in the Least Squares Means|-0.66|||<|0.001|TWO_SIDED|95.0|-0.89|-0.43||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||-0.43|-0.89|<0.001
91613213|NCT02746679|183120719|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
91643118|NCT01939834|183178547|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91769514|NCT04755816|183426052|OTHER|Estimates and confidence intervals are provided|Slope|-12.98|||||TWO_SIDED|95.0|-33.67|7.72|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||7.72|-33.67|
91769515|NCT02653326|183426075|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
91769516|NCT02653326|183426076|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
91769517|NCT00702468|183426102|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.335||||0.013|TWO_SIDED|90.0|0.162|0.691|||Chi-squared|||||0.691|0.162|0.013
91769518|NCT00702468|183426103|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.21||||0.72|TWO_SIDED|90.0|-1.22|0.79|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|||0.79|-1.22|0.720
91769519|NCT00702468|183426104|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.53||||0.86|TWO_SIDED|90.0|-4.68|5.74|||ANCOVA|||||5.74|-4.68|0.86
91580816|NCT01302067|183051618|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91705872|NCT02442206|183306249|SUPERIORITY||Mean Difference (Net)|10.27|||<|0.0001|TWO_SIDED|95.0|6.209|14.331|||ANOVA|||||14.331|6.209|<0.0001
91769520|NCT00702468|183426106|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.78||||0.81|TWO_SIDED|90.0|-14.52|10.96|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||10.96|-14.52|0.81
91769521|NCT00702468|183426107|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.64||||0.271|TWO_SIDED|90.0|-1.6|0.33|||ANCOVA||A negative difference indicates the comparison is in favour of Sativex|||0.33|-1.60|0.271
91769522|NCT00702468|183426108|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.562||||0.017|TWO_SIDED|90.0|1.585|13.997|||Regression, Logistic|||||13.997|1.585|0.017
91705873|NCT02442206|183306250|SUPERIORITY||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.36|0.49|||ANOVA|||||0.49|0.36|<0.0001
91705874|NCT02442206|183306251|SUPERIORITY||Mean Difference (Net)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.8|||ANOVA|||||0.80|0.55|<0.0001
91769523|NCT00702468|183426109|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.55||||0.0011|TWO_SIDED|90.0|3.942|118.773|||Regression, Logistic|||||118.773|3.942|0.0011
91769524|NCT00702468|183426110|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.444||||0.1151|TWO_SIDED|90.0|0.948|13.718|||Regression, Logistic|||||13.718|0.948|0.1151
91769525|NCT04201431|183426131|OTHER|Comparison of pooled data from Groups 1 and 2 volunteers who completed primary CHMI with pooled data of infectivity controls undergoing primary CHMI from VAC069 study running in parallel (NCT03797989).||||||0.01||||||Two tailed p value reported for Mann-Whitney test comparing infectivity controls with vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model||||0.01
91518159|NCT01986881|182910667|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.108|TWO_SIDED|95.8|0.75|1.034|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.034|0.750|0.108
91769526|NCT00300755|183426188|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||<0.001
91769527|NCT00300755|183426188|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||0.063
91769528|NCT00300755|183426188|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||< 0.001
91769529|NCT00300755|183426188|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.004
91769530|NCT00300755|183426188|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.082
91769531|NCT00300755|183426188|SUPERIORITY_OR_OTHER|||||||0.217|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.217
91580817|NCT01302067|183051618|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0040
91580818|NCT01302067|183051618|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580819|NCT01302067|183051619|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91705875|NCT02442206|183306252|SUPERIORITY||Mean Difference (Net)|0.446|||<|0.0001|TWO_SIDED|95.0|0.352|0.541|||ANOVA|||||0.541|0.352|<0.0001
91769532|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.002
91769533|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.033
91769534|NCT00300755|183426189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||<0.001
91769535|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||0.002
91769536|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Refusal to eat.||||0.009
91769537|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.004
91769538|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.044|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.044
91769539|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.002
91518160|NCT01986881|182910667|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.8|0.725|1.057|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.057|0.725|0.150
91580820|NCT01302067|183051619|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580821|NCT01302067|183051619|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580822|NCT01302067|183051620|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.50|-1.02|<0.0001
91580823|NCT01302067|183051620|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0662|TWO_SIDED|95.0|-0.41|0.01||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||0.01|-0.41|0.0662
91580824|NCT01302067|183051620|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.3||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.30|-0.82|<0.0001
91580825|NCT01302067|183051621|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580826|NCT01302067|183051621|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580827|NCT01302067|183051622|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91613214|NCT02746679|183120720|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.003
91613215|NCT02746679|183120721|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.024
91769540|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
91769541|NCT00300755|183426189|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
91769542|NCT00300755|183426190|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Cough without cold.||||0.004
91769543|NCT00300755|183426190|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Noisy breathing.||||0.047
91769544|NCT04571944|183426192|SUPERIORITY||Difference in % vs Placebo|-8.7||||0.129|TWO_SIDED|95.0|-20.1|2.6|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.6|-20.1|0.129
91769545|NCT04571944|183426193|OTHER||Difference in % vs. Placebo|0.8|||||TWO_SIDED|95.0|-9.3|11.0||||||||11.0|-9.3|
91769546|NCT04571944|183426194|OTHER||Difference in % vs. Placebo|0.0|||||TWO_SIDED|95.0|-5.1|5.2||||||||5.2|-5.1|
91769547|NCT04571944|183426195|SUPERIORITY||Difference vs. Placebo|-0.5||||0.485|TWO_SIDED|95.0|-2.0|1.0||Based on aligned rank test.|Hodges-Lehmann method|||||1.0|-2.0|0.485
91769548|NCT04571944|183426196|SUPERIORITY||Difference in % vs. Placebo|-8.6||||0.136|TWO_SIDED|95.0|-20.2|2.8|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.8|-20.2|0.136
91769549|NCT03192826|183426197|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
91769550|NCT03192826|183426198|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
91769551|NCT03192826|183426199|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
91769552|NCT03192826|183426200|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
91769553|NCT02694744|183426201|OTHER||||||||||||||||||If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.|||
91518161|NCT01986881|182910667|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.188|TWO_SIDED|95.8|0.735|1.068|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.068|0.735|0.188
91518162|NCT01986881|182910668|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.385|TWO_SIDED|95.8|0.767|1.113|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.113|0.767|0.385
91769554|NCT02694744|183426202|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7893|TWO_SIDED|95.0|-0.17|0.22|||ANCOVA|||Estimation of mean change in serum potassium from Baseline to week 4.||0.22|-0.17|0.7893
91769555|NCT00883779|183426209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7|||Log Rank|||||0.70|0.46|<0.0001
91769556|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.64|||Log Rank|||PFS in adenocarcinoma subgroup||0.64|0.39|<0.0001
91769557|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||=|0.579|TWO_SIDED|95.0|0.6|1.33|||Log Rank|||PFS in non-adenocarcinoma subgroup||1.33|0.60|=0.579
91769558|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.28|0.53|||Log Rank|||PFS in never smoked subgroup||0.53|0.28|<0.0001
91769559|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||=|0.2067|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||PFS in former/current smoker subgroup||1.10|0.64|=0.2067
91769560|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.12|0.35|||Log Rank|||PFS in subgroup EGFR mutation||0.35|0.12|<0.0001
91518163|NCT01986881|182910668|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.417|TWO_SIDED|95.8|0.739|1.139|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.139|0.739|0.417
91518164|NCT01986881|182910668|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.494|TWO_SIDED|95.8|0.75|1.154|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.154|0.750|0.494
91580828|NCT01302067|183051622|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0006
91613216|NCT02746679|183120722|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.004
91613217|NCT02746679|183120723|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
91769561|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||=|0.7511|TWO_SIDED|95.0|0.67|1.34|||Log Rank|||PFS in subgroup EGFR wild-type||1.34|0.67|=0.7511
91769562|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||=|0.3169|TWO_SIDED|95.0|0.25|1.58|||Log Rank|||PFS in subgroup KRAS mutation||1.58|0.25|=0.3169
91769563|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.7|||Log Rank|||PFS in subgroup KRAS wild-type||0.70|0.37|<0.0001
91769564|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||=|0.0091|TWO_SIDED|95.0|0.31|0.86|||Log Rank|||PFS in subgroup EGFR IHC positive||0.86|0.31|=0.0091
91769565|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0179|TWO_SIDED|95.0|0.18|0.88|||Log Rank|||PFS in subgroup EGFR IHC negative||0.88|0.18|=0.0179
91769566|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||=|0.0017|TWO_SIDED|95.0|0.11|0.64|||Log Rank|||PFS in subgroup EGFR FISH positive||0.64|0.11|=0.0017
91769567|NCT00883779|183426211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||=|0.188|TWO_SIDED|95.0|0.37|1.22|||Log Rank|||PFS in subgroup EGFR FISH negative||1.22|0.37|=0.1880
91769568|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||=|0.1213|TWO_SIDED|95.0|0.7|1.04|||Log Rank|||OS in overall participants (FAS population)||1.04|0.70|=0.1213
91769569|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.0356|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||OS in subgroup adenocarcinoma||0.98|0.62|=0.0356
91769570|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||=|0.1157|TWO_SIDED|95.0|0.92|2.03|||Log Rank|||OS in subgroup non-adenocarcinoma||2.03|0.92|=0.1157
91769571|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||=|0.0056|TWO_SIDED|95.0|0.49|0.89|||Log Rank|||OS in subgroup never smoked||0.89|0.49|=0.0056
91769572|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||=|0.3473|TWO_SIDED|95.0|0.87|1.5|||Log Rank|||OS in subgroup current/former smoker||1.50|0.87|=0.3473
91518165|NCT01986881|182910669|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.081|TWO_SIDED|95.8|0.63|1.036|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.036|0.630|0.081
91518166|NCT01986881|182910669|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.258|TWO_SIDED|95.8|0.638|1.137|||Cox Proportional Hazard Model|"Model included treatment as an explanatory factor and cohort category as a stratification factor.~Renal"||||1.137|0.638|0.258
91518167|NCT01986881|182910669|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.065|TWO_SIDED|95.8|0.568|1.028|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.028|0.568|0.065
91518168|NCT01986881|182910670|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.183|TWO_SIDED|95.0|0.823|1.038||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.038|0.823|0.183
91580829|NCT01302067|183051622|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0001
91580830|NCT01302067|183051623|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.04|-1.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.06|-2.04|<0.0001
91769573|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||=|0.1614|TWO_SIDED|95.0|0.45|1.14|||Log Rank|||OS in subgroup EGFR mutation||1.14|0.45|=0.1614
91580831|NCT01302067|183051623|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0121|TWO_SIDED|95.0|-0.92|-0.11||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.11|-0.92|0.0121
91769574|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.1691|TWO_SIDED|95.0|0.55|1.11|||Log Rank|||OS in subgroup EGFR wild-type||1.11|0.55|=0.1691
91769575|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.1415|TWO_SIDED|95.0|0.19|1.28|||Log Rank|||OS in subgroup KRAS mutation||1.28|0.19|=0.1415
91769576|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||=|0.1447|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||OS in subgroup KRAS wild-type||1.08|0.59|=0.1447
91518169|NCT01986881|182910670|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.831|1.086|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.086|0.831|0.450
91518170|NCT01986881|182910670|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.123|TWO_SIDED|95.0|0.785|1.029|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.029|0.785|0.123
91518171|NCT01986881|182910671|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.676|TWO_SIDED|95.0|0.861|1.259|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.259|0.861|0.676
91518172|NCT01986881|182910671|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.139|TWO_SIDED|95.0|0.949|1.451|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.451|0.949|0.139
91518173|NCT01986881|182910671|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.416|TWO_SIDED|95.0|0.727|1.141|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.141|0.727|0.416
91518174|NCT01986881|182910672|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.663|TWO_SIDED|95.0|0.82|1.365||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|||1.365|0.820|0.663
91613218|NCT02746679|183120724|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
91613219|NCT02746679|183120725|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.277
91769577|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||=|0.031|TWO_SIDED|95.0|0.35|0.96|||Log Rank|||OS in EGFR IHC positive||0.96|0.35|=0.0310
91769578|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||=|0.0581|TWO_SIDED|95.0|0.21|1.05|||Log Rank|||OS in subgroup EGFR IHC negative||1.05|0.21|=0.0581
91769579|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||=|0.0063|TWO_SIDED|95.0|0.14|0.75|||Log Rank|||OS of subgroup EGFR FISH positive||0.75|0.14|=0.0063
91769580|NCT00883779|183426212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||=|0.3268|TWO_SIDED|95.0|0.4|1.36|||Log Rank|||OS of subgroup EGFR FISH negative||1.36|0.40|=0.3268
91769581|NCT00883779|183426214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81|||=|0.5289|TWO_SIDED|95.0|-6.2|11.8|||Chi-squared|||Difference in non-progression response rates||11.8|-6.2|=0.5289
91769582|NCT00883779|183426215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.14|||<|0.0001|TWO_SIDED|95.0|16.7|33.5|||Chi-squared|||Difference in objective response rates||33.5|16.7|<0.0001
91769583|NCT00883779|183426216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.5|||Log Rank|||||0.50|0.21|<0.0001
91518175|NCT01986881|182910672|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.415|TWO_SIDED|95.0|0.845|1.505||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.505|0.845|0.415
91580832|NCT01302067|183051623|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.52|-0.55||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.55|-1.52|<0.0001
91580833|NCT01302067|183051624|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.55|-1.49||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.49|-2.55|<0.0001
91580834|NCT01302067|183051624|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.22||0.0005|TWO_SIDED|95.0|-1.22|-0.34||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.34|-1.22|0.0005
91580835|NCT01302067|183051624|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.77|-0.71||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.71|-1.77|<0.0001
91580836|NCT01302067|183051625|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91769584|NCT00883779|183426217|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.69|||Log Rank|||||0.69|0.45|<0.0001
91769585|NCT00883779|183426219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||=|0.0364|TWO_SIDED|95.0|0.63|0.99|||Log Rank|||||0.99|0.63|=0.0364
91580837|NCT01302067|183051625|SUPERIORITY_OR_OTHER|||||||0.0348|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0348
91580838|NCT01302067|183051625|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0003
91580839|NCT01302067|183051626|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580840|NCT01302067|183051626|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0002
91580841|NCT01302067|183051626|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
91580842|NCT01302067|183051627|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||<0.0001
91580843|NCT01302067|183051627|SUPERIORITY_OR_OTHER|||||||0.0057|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0057
91613220|NCT02746679|183120726|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
91769586|NCT00883779|183426221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||=|0.0181|TWO_SIDED|95.0|0.61|0.96|||Log Rank|||||0.96|0.61|=0.0181
91769587|NCT00883779|183426223|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.73|||=|0.0035|TWO_SIDED|95.0|0.59|0.9|||Log Rank|||||0.90|0.59|=0.0035
91769588|NCT00883779|183426224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.913|TWO_SIDED|95.0|0.6|1.59|||Log Rank|||||1.59|0.60|0.9130
91790123|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.685
91790124|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.257||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.257
91580844|NCT01302067|183051627|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0008
91580845|NCT01302067|183051628|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0007
91580846|NCT01302067|183051628|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0091
91518176|NCT01986881|182910672|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.953|TWO_SIDED|95.0|0.736|1.334||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.334|0.736|0.953
91518177|NCT01986881|182910673|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.006|TWO_SIDED|95.0|0.539|0.902||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||0.902|0.539|0.006
91518178|NCT01986881|182910673|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.016|TWO_SIDED|95.0|0.502|0.932|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.932|0.502|0.016
91580847|NCT01302067|183051628|SUPERIORITY_OR_OTHER|||||||0.3901|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.3901
91769589|NCT03748823|183426244|NON_INFERIORITY|Noninferiority was determined based on the 90% Confidence interval calculated from the combination z-score that accounts for the interim analysis.|Ratio of Geometric Least Squares Mean|1.257|||<|0.0001|TWO_SIDED|90.0|1.16|1.361||Analysis of variance (ANOVA) was performed on log-transformed Ctrough and included treatment and stratified weight group as fixed effects.|ANOVA||Geometric least squares mean are the least squares mean from the mixed model after back transformation to the original scale. The 90% confidence interval is presented after back transformation to the original scale.|||1.361|1.160|<0.0001
91580848|NCT01302067|183051629|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.47|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-15.49|-9.45||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-9.45|-15.49|<0.0001
91580849|NCT01302067|183051629|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.0002|TWO_SIDED|95.0|-7.15|-2.22||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-2.22|-7.15|0.0002
91580850|NCT01302067|183051629|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.78|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|95.0|-10.78|-4.78||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-4.78|-10.78|<0.0001
91580851|NCT01302067|183051630|SUPERIORITY_OR_OTHER||Least squares mean difference|10.46|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|7.2|13.73||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||13.73|7.20|<0.0001
91613221|NCT01520922|183120791|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|84.53|99.44|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m\^2.|||99.44|84.53|
91705876|NCT02442206|183306253|SUPERIORITY||Mean Difference (Net)|-0.177||||0.0017|TWO_SIDED|95.0|-0.285|-0.07|||ANOVA|||||-0.070|-0.285|0.0017
91705877|NCT02442206|183306254|SUPERIORITY||Mean Difference (Net)|-0.751|||<|0.0001|TWO_SIDED|95.0|-0.925|-0.577|||ANOVA|||||-0.577|-0.925|<0.0001
91705878|NCT02442206|183306255|SUPERIORITY||Mean Difference (Net)|-1.639|||<|0.0001|TWO_SIDED|95.0|-1.945|-1.332|||ANOVA|||||-1.332|-1.945|<0.0001
91790125|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 1||||0.0099
91518179|NCT01986881|182910673|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.028|TWO_SIDED|95.0|0.524|0.964|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.964|0.524|0.028
91524185|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
91580852|NCT01302067|183051630|SUPERIORITY_OR_OTHER||Least squares mean difference|4.68|STANDARD_ERROR_OF_MEAN|1.36||0.0006|TWO_SIDED|95.0|2.01|7.36||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.36|2.01|0.0006
91580853|NCT01302067|183051630|SUPERIORITY_OR_OTHER||Least squares mean difference|5.78|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|2.53|9.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.03|2.53|0.0005
91518180|NCT01986881|182910674|SUPERIORITY|Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|0.93||||0.34|TWO_SIDED|95.0|0.797|1.081||Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.081|0.797|0.340
91518181|NCT01986881|182910674|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.463|TWO_SIDED|95.0|0.784|1.117|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.117|0.784|0.463
91518182|NCT01986881|182910674|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.363|TWO_SIDED|95.0|0.771|1.1|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.100|0.771|0.363
91580854|NCT01302067|183051631|SUPERIORITY_OR_OTHER||Least squares mean difference|10.91|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|7.73|14.09||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||14.09|7.73|<0.0001
91580855|NCT01302067|183051631|SUPERIORITY_OR_OTHER||Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|1.33||0.001|TWO_SIDED|95.0|1.76|6.96||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.96|1.76|0.0010
91769590|NCT00890825|183426260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2069|TWO_SIDED|80.0|0.56|1.14||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.|Regression, Cox|Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status|A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel|||1.14|0.56|0.2069
91580856|NCT01302067|183051631|SUPERIORITY_OR_OTHER||Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|3.39|9.72||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.72|3.39|<0.0001
91613222|NCT01520922|183120791|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|59.67|84.74|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m\^2.|||84.74|59.67|
91613223|NCT01422304|183120831|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.38|1.29|||Cochran-Mantel-Haenszel||Relative risk is Sugammadex versus Usual Care|Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance \< or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin \[LMWH\], including unfractionated heparin \[UFH\], or not including either LMWH or UFH)||1.29|0.38|
91769591|NCT00890825|183426261|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0138|TWO_SIDED|80.0|0.42|0.79||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Regression, Cox|The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.|A Hazard Ratio (HR) \< 1 favoured AZD6244 + Docetaxel|||0.79|0.42|0.0138
91769592|NCT00890825|183426262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|37.2|||<|0.0001|TWO_SIDED|95.0|23.0|53.0||Two-sided P-value|Fisher Exact|||||53|23|< 0.0001
91769593|NCT00890825|183426264|SUPERIORITY_OR_OTHER||LSmeans difference|-17.03||||0.004|TWO_SIDED|80.0|-25.2|-8.86||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-8.86|-25.2|0.004
91790126|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 2||||0.0654
91518183|NCT01986881|182910675|SUPERIORITY|Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.898|1.131||||||||1.131|0.898|
91518184|NCT01986881|182910675|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.937|1.219||||||||1.219|0.937|
91518185|NCT01986881|182910675|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.828|1.085||||||||1.085|0.828|
91518186|NCT01986881|182910676|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.716|0.945||||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.||0.945|0.716|
91518187|NCT01986881|182910676|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.673|0.935|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||0.935|0.673|
91580857|NCT01302067|183051632|SUPERIORITY_OR_OTHER||Least squares mean difference|7.46|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|4.4|10.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||10.51|4.40|<0.0001
91580858|NCT01302067|183051632|SUPERIORITY_OR_OTHER||Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|1.27||0.0034|TWO_SIDED|95.0|1.24|6.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.23|1.24|0.0034
91580859|NCT01302067|183051632|SUPERIORITY_OR_OTHER||Least squares mean difference|3.72|STANDARD_ERROR_OF_MEAN|1.55||0.0164|TWO_SIDED|95.0|0.68|6.76||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.76|0.68|0.0164
91580860|NCT01302067|183051633|SUPERIORITY_OR_OTHER||Least squares mean difference|7.5|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|5.03|9.97||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.97|5.03|<0.0001
91580861|NCT01302067|183051633|SUPERIORITY_OR_OTHER||Least squares mean difference|3.68|STANDARD_ERROR_OF_MEAN|1.03||0.0004|TWO_SIDED|95.0|1.65|5.7||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||5.70|1.65|0.0004
91580862|NCT01302067|183051633|SUPERIORITY_OR_OTHER||Least squares mean difference|3.82|STANDARD_ERROR_OF_MEAN|1.25||0.0023|TWO_SIDED|95.0|1.36|6.28||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.28|1.36|0.0023
91518188|NCT01986881|182910676|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.725|1.001|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||1.001|0.725|
91518189|NCT01986881|182910677|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.46|||cLDA Model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.46|-0.55|<0.001
91518190|NCT01986881|182910677|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.53|-0.44|||cLDA model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.44|-0.53|<0.001
91580863|NCT01302067|183051634|SUPERIORITY_OR_OTHER||Least squares mean difference|9.37|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|6.56|12.18||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||12.18|6.56|<0.0001
91580864|NCT01302067|183051634|SUPERIORITY_OR_OTHER||Least squares mean difference|4.23|STANDARD_ERROR_OF_MEAN|1.17||0.0003|TWO_SIDED|95.0|1.93|6.53||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.53|1.93|0.0003
91580865|NCT01302067|183051634|SUPERIORITY_OR_OTHER||Least squares mean difference|5.14|STANDARD_ERROR_OF_MEAN|1.43||0.0003|TWO_SIDED|95.0|2.34|7.94||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.94|2.34|0.0003
91769594|NCT00890825|183426265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0||||0.004|TWO_SIDED|80.0|-38.34|-13.7||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-13.7|-38.34|0.004
91790127|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1807||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 3||||0.1807
91518191|NCT01986881|182910678|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.54|-0.43|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.43|-0.54|<0.001
91580866|NCT01302067|183051635|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0016
91705879|NCT02442206|183306256|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.761|-0.489|||ANOVA|||||-0.489|-0.761|<0.0001
91518192|NCT01986881|182910678|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.45|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.45|-0.55|<0.001
91518193|NCT01986881|182910679|SUPERIORITY||Difference in the least squares means|-0.37|||<|0.001|TWO_SIDED|95.0|-0.45|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||Ertugliflozin vs. Placebo|||-0.30|-0.45|<0.001
91518194|NCT01986881|182910679|SUPERIORITY||Difference in Least Squares Means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.46|-0.32||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|Ertugliflozin vs. Placebo.||||-0.32|-0.46|<0.001
91518195|NCT01986881|182910681|SUPERIORITY||Difference in the least squares means|-0.31||||0.001|TWO_SIDED|95.0|-0.41|-0.21||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-0.21|-0.41|0.001
91518196|NCT01986881|182910681|SUPERIORITY||Difference in the least squares means|-0.36|||<|0.001|TWO_SIDED|95.0|-0.46|-0.26||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA model|||||-0.26|-0.46|<0.001
91518197|NCT01986881|182910696|SUPERIORITY||Difference in the Least Squares Means|-17.56|||<|0.001|TWO_SIDED|95.0|-19.49|-15.63|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-15.63|-19.49|<0.001
91518198|NCT01986881|182910696|SUPERIORITY||Difference in the Least Squares Means|-15.1|||<|0.001|TWO_SIDED|95.0|-17.03|-13.17|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-13.17|-17.03|<0.001
91580867|NCT01302067|183051635|SUPERIORITY_OR_OTHER|||||||0.8121|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.8121
91580868|NCT01302067|183051635|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0015
91580869|NCT01302067|183051636|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||<0.0001
91580870|NCT01302067|183051636|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0006
91580871|NCT01302067|183051636|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0027
91580872|NCT02480153|183051645|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if the 2-sided 95% CI fell within (-14%, 14%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|95.0|-10.38|4.44||||||||4.44|-10.38|
91580873|NCT02480153|183051645|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if 2-sided 90% CI fell within (-12%, 15%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|90.0|-9.25|3.28||||||||3.28|-9.25|
91580874|NCT03241225|183051713|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.16|TWO_SIDED|95.0|-1.43|8.61|||t-test, 2 sided||Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.|Week 12||8.61|-1.43|0.16
91518199|NCT01986881|182910703|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
91518200|NCT01986881|182910703|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
91518201|NCT01986881|182910704|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
91518202|NCT01986881|182910704|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
91580875|NCT03241225|183051714|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.79|TWO_SIDED|95.0|-1.37|1.05|||t-test, 2 sided|||Domain #1, Week 12||1.05|-1.37|0.79
91580876|NCT03241225|183051714|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.19|TWO_SIDED|95.0|-0.7|3.46|||t-test, 2 sided|||Domain #2, Week 12||3.46|-0.70|0.19
91580877|NCT03241225|183051714|SUPERIORITY||Mean Difference (Final Values)|-4.53||||0.37|TWO_SIDED|95.0|-14.99|5.93|||t-test, 2 sided|||Domain #3, Week 12||5.93|-14.99|0.37
91580878|NCT03241225|183051714|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.026|TWO_SIDED|95.0|-9.75|-0.73|||t-test, 2 sided|||Domain #4, Week 12||-0.73|-9.75|0.026
91580879|NCT03241225|183051714|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.66|TWO_SIDED|95.0|-3.51|2.27|||t-test, 2 sided|||Domain #5, Week 12||2.27|-3.51|0.66
91518203|NCT01986881|182910712|SUPERIORITY||Difference in the Least Squares Means|-2.78|||<|0.001|TWO_SIDED|95.0|-3.45|-2.1|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-3.45|<0.001
91518204|NCT01986881|182910712|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-3.21|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.21|<0.001
91518205|NCT01986881|182910713|SUPERIORITY||Difference in the Least Squares Mean|-3.15|||<|0.001|TWO_SIDED|95.0|-3.85|-2.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.45|-3.85|<0.001
91518206|NCT01986881|182910713|SUPERIORITY||Difference in the Least Squares Means|-2.58|||<|0.001|TWO_SIDED|95.0|-3.28|-1.89|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.89|-3.28|<0.001
91518207|NCT01986881|182910714|SUPERIORITY||Difference in the Least Squares Means|-2.72|||<|0.001|TWO_SIDED|95.0|-3.57|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.57|<0.001
91518208|NCT01986881|182910714|SUPERIORITY||Difference in the Least Squares Means|-2.7|||<|0.001|TWO_SIDED|95.0|-3.56|-1.85|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.85|-3.56|<0.001
91518209|NCT01986881|182910716|SUPERIORITY||Difference in the Least Squares Means|-2.6|||<|0.001|TWO_SIDED|95.0|-3.68|-1.52|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.52|-3.68|<0.001
91580880|NCT03241225|183051715|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.14|TWO_SIDED|95.0|-0.26|1.66|||t-test, 2 sided|||Domain #1, Week 12||1.66|-0.26|0.14
91580881|NCT03241225|183051715|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.047|TWO_SIDED|95.0|0.011|1.55||Domain #2|t-test, 2 sided|||Domain #2, Week 12||1.55|0.011|0.047
91518210|NCT01986881|182910716|SUPERIORITY||Difference in the Least Squares Means|-2.79|||<|0.001|TWO_SIDED|95.0|-3.87|-1.71|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.71|-3.87|<0.001
91518211|NCT01986881|182910719|SUPERIORITY||Difference in the Least Squares Means|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.56|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.56|-1.37|<0.001
91518212|NCT01986881|182910719|SUPERIORITY||Difference in the Least Means Squares|-0.87|||<|0.001|TWO_SIDED|95.0|-1.28|-0.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.47|-1.28|<0.001
91518213|NCT01986881|182910720|SUPERIORITY||Difference in the Least Squares Means|-0.81|||<|0.001|TWO_SIDED|95.0|-1.22|-0.39|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.39|-1.22|<0.001
91518214|NCT01986881|182910720|SUPERIORITY||Difference in the Least Squares Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.24|-0.41|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.41|-1.24|<0.001
91580882|NCT03241225|183051715|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.18|TWO_SIDED|95.0|-0.34|1.64|||t-test, 2 sided|||Domain #3, Week 12||1.64|-0.34|0.18
91580883|NCT00852540|183051716|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|45.5|68.4|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||68.4|45.5|
91580884|NCT00852540|183051716|SUPERIORITY_OR_OTHER||Percentage of participants|84.2|||||TWO_SIDED|95.0|72.6|95.8|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||95.8|72.6|
91580885|NCT00435591|183051734|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.37|0.83||||||"Aggregated data were used to determine differences between groups. Statistical analysis is relevant to the aggregated data of all rows except the no assessment row."||0.83|-0.37|
91580886|NCT01346475|183051803|SUPERIORITY_OR_OTHER||Incident Risk Ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.44|0.66|||Incident risk ratio|The model is adjusted for period effects.||This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.||0.66|0.44|<0.001
91580887|NCT00558259|183051810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.02|0.25|||Regression, Cox|||Dabigatran vs placebo||0.25|0.02|<0.0001
91580888|NCT00558259|183051811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.03|0.27|||Regression, Cox|||Dabigatran vs placebo||0.27|0.03|<0.0001
91580889|NCT00558259|183051812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||< 0.0001
91580890|NCT00558259|183051812|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.06|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.|||1.06|0.04|
91580891|NCT00558259|183051812|SUPERIORITY_OR_OTHER||Percentage of participants with events|3.5|||||TWO_SIDED|95.0|2.21|5.17|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.|||5.17|2.21|
91580892|NCT00558259|183051813|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.0004
91580893|NCT00558259|183051813|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.1|||||TWO_SIDED|95.0|0.0|0.82|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.|||0.82|0.00|
91580894|NCT00558259|183051813|SUPERIORITY_OR_OTHER||Percentage of participants with events|2.1|||||TWO_SIDED|95.0|1.16|3.52|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.|||3.52|1.16|
91580895|NCT00558259|183051814|SUPERIORITY_OR_OTHER|||||||0.2428|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.2428
91580896|NCT00558259|183051814|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.|||0.54|0.00|
91580897|NCT00558259|183051814|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.09|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.|||1.09|0.04|
91580898|NCT00558259|183051815|SUPERIORITY_OR_OTHER|||||||0.4998||||||As the Cox model did not converge due to too few events, hazard ratios are not estimable.|Fisher Exact|||Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.||||0.4998
91580899|NCT00558259|183051815|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.05|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.|||1.05|0.04|
91580900|NCT00558259|183051815|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.56|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.|||0.56|0.00|
91580901|NCT00558259|183051815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.92|STANDARD_ERROR_OF_MEAN|0.97||0.0013|TWO_SIDED|95.0|1.52|5.6|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.||5.60|1.52|0.0013
91518215|NCT01986881|182910721|SUPERIORITY||Difference in the Least Squares Means|-0.67||||0.01|TWO_SIDED|95.0|-1.19|-0.16|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.16|-1.19|0.010
91580902|NCT00558259|183051815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.82|STANDARD_ERROR_OF_MEAN|0.36||0.0027|TWO_SIDED|95.0|1.23|2.68|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated||2.68|1.23|0.0027
91580903|NCT02318992|183051905|OTHER|||||||0.157|||||||Chi-squared, Corrected|||||||0.157
91580904|NCT02318992|183051906|OTHER|||||||0.041|||||||Chi-squared, Corrected|||||||0.041
91580905|NCT00682890|183051930|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANOVA|||P value on change at 3 months for placebo group||||0.63
91580906|NCT00682890|183051930|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||0.42
91580907|NCT00682890|183051931|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||||||0.51
91580908|NCT00682890|183051931|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
91769595|NCT00890825|183426266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0158|TWO_SIDED|80.0|0.37|0.78||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Log Rank|Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate|A hazard ratio (HR) \<1 favours AZD6244 75 mg bd+Docetaxel|||0.78|0.37|0.0158
91580909|NCT03028220|183051932|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91580910|NCT03028220|183051933|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91580911|NCT03028220|183051934|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91705880|NCT02442206|183306257|SUPERIORITY||Mean Difference (Net)|1.209||||0.142|TWO_SIDED|95.0|-0.419|2.836|||ANOVA|||LV EF||2.836|-0.419|0.1420
91705881|NCT02442206|183306257|SUPERIORITY||Mean Difference (Net)|1.131||||0.1732|TWO_SIDED|95.0|-0.512|2.774|||ANOVA|||RV EF||2.774|-0.512|0.1732
91580912|NCT03028220|183051935|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91580913|NCT03028220|183051936|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91580914|NCT03028220|183051937|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
91580915|NCT03028220|183051938|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
91580916|NCT03028220|183051939|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.570
91580917|NCT03028220|183051940|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91580918|NCT03028220|183051941|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
91518216|NCT01986881|182910721|SUPERIORITY||Difference in the Least Squares Means|-0.71||||0.006|TWO_SIDED|95.0|-1.22|-0.2|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.20|-1.22|0.006
91518217|NCT01986881|182910723|SUPERIORITY||Difference in the least squares means|-0.78||||0.024|TWO_SIDED|95.0|-1.46|-0.1||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.10|-1.46|0.024
91580919|NCT03028220|183051942|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.460
91580920|NCT03028220|183051943|OTHER|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
91580921|NCT00141219|183051944|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.115||||0.289||95.0|0.785|1.583||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||1.583|0.785|0.289
91580922|NCT00141219|183051945|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.644||||0.041||95.0|0.915|2.954||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||2.954|0.915|0.041
91580923|NCT00141219|183051946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.049||95.0|-1.0|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from the general linear model with treatment and center fitted as factors and the baseline value as a covariate.||Null hypotheses stated there was no difference in pregabalin and placebo in the primary endpoint versus the alternative that there was. The target sample size was 234 subjects (156 and 78 respectively pregabalin vs placebo using a 2:1 ratio). The calculations assumed a 2-sided comparison at 0.05 alpha, 80% power and 3% dropout. Also, a treatment difference of 1 point and a standard deviation for endpoint mean pain scores of 2.5 were assumed based on previous studies.||-0.00|-1.00|0.049
91580924|NCT00141219|183051946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.729||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 1, a treatment by center independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across centers.||||0.729
91580925|NCT00141219|183051946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.979||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 2, a treatment by baseline mean pain independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across different baseline values.||||0.979
91705882|NCT02442206|183306258|SUPERIORITY||Mean Difference (Net)|2.241||||0.0437|TWO_SIDED|95.0|0.066|4.417|||ANOVA|||LV ESV||4.417|0.066|0.0437
91705883|NCT02442206|183306258|SUPERIORITY||Mean Difference (Net)|2.095||||0.1236|TWO_SIDED|95.0|-0.591|4.782|||ANOVA|||RV ESV||4.782|-0.591|0.1236
91705884|NCT02442206|183306259|SUPERIORITY||Mean Difference (Net)|9.357||||0.0002|TWO_SIDED|95.0|4.649|14.065|||ANOVA|||||14.065|4.649|0.0002
91705885|NCT02442206|183306260|SUPERIORITY||Mean Difference (Net)|0.337||||0.0032|TWO_SIDED|95.0|0.118|0.555|||ANOVA|||LVCO||0.555|0.118|0.0032
91580926|NCT00141219|183051947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.267||0.077||95.0|-1.0|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center fitted as factors and the baseline value as a covariate.||"Endpoint Mean Pain Score~Pregabalin minus Placebo"||0.05|-1.00|0.077
91580927|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.042||95.0|-0.75|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center, and treatment by week interaction as factors and baseline value as a covariate.||"Mean Pain Score Weeks 1 to 8~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.01|-0.75|0.042
91580928|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.071||95.0|-0.79|0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Mean Pain Score~Pregabalin minus Placebo"||0.03|-0.79|0.071
91705886|NCT02442206|183306260|SUPERIORITY||Mean Difference (Net)|0.281||||0.0182|TWO_SIDED|95.0|0.05|0.512|||ANOVA|||RVCO||0.512|0.050|0.0182
91769596|NCT01363700|183426267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.11|||t-test, 2 sided|||||-1.11|-1.52|<0.001
91769597|NCT01363700|183426268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.71|-0.92|||t-test, 2 sided|||||-0.92|-1.71|<0.001
91769598|NCT01363700|183426269|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular itching score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.21|0.08||||||||0.08|-0.21|
91769599|NCT01363700|183426270|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular hyperemia score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.81|0.22||||||||0.22|-0.81|
91769600|NCT02920892|183426271|SUPERIORITY||Slope|-0.1||||0.1587|TWO_SIDED|90.0|-0.22|0.02|||Mixed Models Analysis|||||0.02|-0.22|0.1587
91769601|NCT02920892|183426272|SUPERIORITY||Slope|-1.66||||0.1054|TWO_SIDED|90.0|-3.34|0.03|||Mixed Models Analysis|||||0.03|-3.34|0.1054
91580929|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.212||0.149||95.0|-0.72|0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Mean Pain Score~Pregabalin minus Placebo"||0.11|-0.72|0.149
91580930|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.213||0.057||95.0|-0.82|0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Mean Pain Score~Pregabalin minus Placebo"||0.01|-0.82|0.057
91705887|NCT03300050|183306317|OTHER||GMT Ratio|2.73|||<|0.0001|TWO_SIDED|95.0|1.73|4.29|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted Geometric Mean Titer (GMT) Ratio 28 Days Post-Boost Dose||4.29|1.73|<0.0001
91769602|NCT02920892|183426273|SUPERIORITY||Slope|-0.67||||0.32|TWO_SIDED|90.0|-1.79|0.45|||Mixed Models Analysis|||||0.45|-1.79|0.32
91769603|NCT02920892|183426274|SUPERIORITY||Slope|-0.29||||0.78|TWO_SIDED|90.0|-1.98|1.4|||Mixed Models Analysis|||||1.4|-1.98|0.78
91769604|NCT02920892|183426275|SUPERIORITY||Slope|0.1||||0.94|TWO_SIDED|90.0|-2.05|2.24|||Mixed Models Analysis|||||2.24|-2.05|0.94
91769605|NCT02920892|183426276|SUPERIORITY||Slope|-0.85||||0.1428|TWO_SIDED|90.0|-1.81|0.11|||Mixed Models Analysis|||||0.11|-1.81|0.1428
91769606|NCT02920892|183426277|SUPERIORITY||Odds Ratio (OR)|0.9462||||0.24|TWO_SIDED|90.0|0.8764|1.0215|||Mixed Models Analysis|||||1.0215|0.8764|0.24
91769607|NCT02920892|183426278|SUPERIORITY||Odds Ratio (OR)|0.95||||0.92|TWO_SIDED|90.0|0.4|2.27|||Mixed Models Analysis|||||2.27|0.4|0.92
91769608|NCT03649217|183426279|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
91769609|NCT03649217|183426280|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
91769610|NCT03649217|183426281|SUPERIORITY|||||||0.001|||||||ANOVA|||||||.001
91769611|NCT03649217|183426282|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||.0002
91769612|NCT03649217|183426283|SUPERIORITY|||||||0.006|||||||ANOVA|||||||.006
91769613|NCT01721161|183426284|SUPERIORITY_OR_OTHER||Difference|-3.48||||0.3337|TWO_SIDED|95.0|-10.61|3.65|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||3.65|-10.61|0.3337
91769614|NCT01721161|183426285|SUPERIORITY_OR_OTHER||Difference|-3.89||||0.1868|TWO_SIDED|95.0|-9.7|1.92|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||1.92|-9.70|0.1868
91769615|NCT01721161|183426286|SUPERIORITY_OR_OTHER||Difference|-4.76||||0.1488|TWO_SIDED|95.0|-11.26|1.74|||ANCOVA|||||1.74|-11.26|0.1488
91769616|NCT01721161|183426287|SUPERIORITY_OR_OTHER||Difference|-1.15||||0.4975|TWO_SIDED|95.0|-4.51|2.21|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||2.21|-4.51|0.4975
91769617|NCT01721161|183426288|SUPERIORITY_OR_OTHER||Difference|-1.76||||0.3505|TWO_SIDED|95.0|-5.5|1.98|||ANCOVA|||||1.98|-5.50|0.3505
91769618|NCT01721161|183426289|SUPERIORITY_OR_OTHER||Difference|-1.6||||0.5371|TWO_SIDED|95.0|-6.9|3.6|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 1.25% chart||3.6|-6.9|0.5371
91769619|NCT01721161|183426289|SUPERIORITY_OR_OTHER||Difference|-0.8||||0.7741|TWO_SIDED|95.0|-6.5|4.9|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 2.5% chart||4.9|-6.5|0.7741
91769620|NCT01721161|183426290|SUPERIORITY_OR_OTHER||Difference|-1.2||||0.6645|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|||LCLA 1.25% chart||4.3|-6.6|0.6645
91769621|NCT01721161|183426290|SUPERIORITY_OR_OTHER||DIfference|-0.8||||0.8015|TWO_SIDED|95.0|-6.7|5.2|||ANCOVA|||LCLA 2.5%||5.2|-6.7|0.8015
91580931|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.215||0.044||95.0|-0.85|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Mean Pain Score~Pregabalin minus Placebo"||-0.01|-0.85|0.044
91580932|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.216||0.051||95.0|-0.85|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Mean Pain Score~Pregabalin minus Placebo"||0.00|-0.85|0.051
91580933|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.216||0.178||95.0|-0.72|0.13||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Mean Pain Score~Pregabalin minus Placebo"||0.13|-0.72|0.178
91580934|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.218||0.104||95.0|-0.78|0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Mean Pain Score~Pregabalin minus Placebo"||0.07|-0.78|0.104
91580935|NCT00141219|183051948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.218||0.039||95.0|-0.88|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Mean Pain Score~Pregabalin minus Placebo"||-0.02|-0.88|0.039
91705888|NCT03300050|183306317|OTHER||GMT Ratio|1.06||||0.9411|TWO_SIDED|95.0|0.68|1.66|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.66|0.68|0.9411
91705889|NCT03300050|183306317|OTHER||GMT Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.62|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||0.62|0.24|<0.0001
91769622|NCT01721161|183426291|SUPERIORITY_OR_OTHER||Difference|-7.55||||0.0504|TWO_SIDED|95.0|-15.12|0.01|||ANCOVA|||||0.01|-15.12|0.0504
91769623|NCT01216202|183426294|SUPERIORITY|||||||0.014||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||The association between change in serum testosterone levels and cumulative mean testicular radiation dose was assessed using longitudinal regression analysis (GEE). No preoperative RT contributed with baseline values.||||0.014
91769624|NCT01216202|183426295|SUPERIORITY||Estimated mean change|-4.0||||0.008|TWO_SIDED|95.0|-6.9|-1.0||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for time between preoperative radiotherapy (RT) and surgery.||The association between change in total number of sperms per ejaculate and relative mean testicular dose was assessed using longitudinal regression analysis (GEE).||-1.0|-6.9|0.008
91580936|NCT00141219|183051949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.044||95.0|-0.74|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Duration Adjusted Average Change (DAAC)~Pregabalin minus Placebo"||-0.01|-0.74|0.044
91580937|NCT00141219|183051950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.272||0.018||95.0|-1.19|-0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Sleep Interference Score~Pregabalin minus Placebo"||-0.11|-1.19|0.018
91580938|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.226||0.024||95.0|-0.96|-0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Weeks 1 to 8 Mean Sleep Score~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.07|-0.96|0.024
91580939|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.245||0.12||95.0|-0.86|0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Sleep Interference Score~Pregabalin minus Placebo"||0.10|-0.86|0.120
91705890|NCT03300050|183306318|OTHER||Difference|59.6||||0.0025|TWO_SIDED|95.0|23.59|81.02|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||81.02|23.59|0.0025
91769625|NCT00614380|183426304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||||95.0|0.22|0.53|||Cochran-Mantel-Haenszel|||||0.53|0.22|
91769626|NCT00614380|183426304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||||95.0|0.12|0.81|||Cochran-Mantel-Haenszel|||||0.81|0.12|
91769627|NCT00614380|183426304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||||95.0|0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|0.06|
91769628|NCT00614380|183426304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||||95.0|0.34|2.41|||Cochran-Mantel-Haenszel|||||2.41|0.34|
91769629|NCT00614380|183426304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||||95.0|0.16|0.39|||Cochran-Mantel-Haenszel|||||0.39|0.16|
91769630|NCT00614380|183426304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.1|0.72|||Cochran-Mantel-Haenszel|||||0.72|0.10|
91769631|NCT00462306|183426343|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05|Chi-squared, Corrected|||We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.||||0.001
91769632|NCT00462306|183426344|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
91580940|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.246||0.041||95.0|-0.99|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Sleep Interference Score~Pregabalin minus Placebo"||-0.02|-0.99|0.041
91580941|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.248||0.017||95.0|-1.07|-0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Sleep Interference Score~Pregabalin minus Placebo"||-0.10|-1.07|0.017
91580942|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.249||0.033||95.0|-1.02|-0.04||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Sleep Interference Score~Pregabalin minus Placebo"||-0.04|-1.02|0.033
91580943|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.25||0.078||95.0|-0.93|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Sleep Interference Score~Pregabalin minus Placebo"||0.05|-0.93|0.078
91580944|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.038||95.0|-1.01|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.01|0.038
91769633|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.483
91769634|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.698
91769635|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.782
91580945|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.252||0.037||95.0|-1.02|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.02|0.037
91580946|NCT00141219|183051951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.252||0.015||95.0|-1.11|-0.12||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Sleep Interference Score~Pregabalin minus Placebo"||-0.12|-1.11|0.015
91580947|NCT00141219|183051952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|2.639||0.034||95.0|-10.82|-0.42||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Disturbance~Pregabalin minus Placebo"||-0.42|-10.82|0.034
91580948|NCT00141219|183051953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.05|STANDARD_ERROR_OF_MEAN|3.309||0.128||95.0|-1.47|11.58||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Snoring Score~Pregabalin minus Placebo"||11.58|-1.47|0.128
91580949|NCT00141219|183051954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.887||0.103||95.0|-6.81|0.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Awaken Short of Breath or Headache~Pregabalin minus Placebo"||0.63|-6.81|0.103
91769636|NCT00452790|183426361|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91769637|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.729||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.729
91580950|NCT00141219|183051955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.182||0.018||95.0|0.08|0.8||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Quantity~Pregabalin minus Placebo"||0.80|0.08|0.018
91613882|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.758||||0.0087|TWO_SIDED|95.0|0.616|0.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.932|0.616|0.0087
91580951|NCT00141219|183051956|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23|STANDARD_ERROR_OF_MEAN|0.37||0.504||95.0|0.67|2.24||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Regression, Logistic|OR estimated from model with Optimal sleep status (Yes/No) as response variable, and treatment, baseline Optimal sleep status as explanatory variables|"The OR estimates ratio of Odds of optimal sleep between Pregabalin and Placebo (ie, the former to the latter). Odds of optimal sleep in treatment group is ratio of Probability of having optimal sleep vs Probability of Not having optimal sleep"|"Week 8 Optimal Sleep~Optimal Sleep is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.~Odds ratio measured the odds of optimal sleep in pregabalin to that in placebo.~Standard Error of the Mean equals Standard Error of the Odds Ratio (OR)."||2.24|0.67|.504
91580952|NCT00141219|183051957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.796||0.571||95.0|-5.33|9.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Adequacy~Pregabalin minus Placebo"||9.63|-5.33|0.571
91580953|NCT00141219|183051958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|2.349||0.046||95.0|0.08|9.34||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Somnolence~Pregabalin minus Placebo"||9.34|0.08|0.046
91580954|NCT00141219|183051959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|2.044||0.3||95.0|-6.15|1.91||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Overall Sleep Problem~Pregabalin minus Placebo"||1.91|-6.15|0.300
91580955|NCT00141219|183051960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.0325||0.429||95.0|-0.038|0.09||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Utility Score~Pregabalin minus Placebo"||0.090|-0.038|0.429
91580956|NCT00141219|183051961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|2.375||0.142||95.0|-1.18|8.18||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint VAS Score~Pregabalin minus Placebo"||8.18|-1.18|0.142
91769638|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91769639|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.819||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.819
91769640|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.904
91580957|NCT00141219|183051962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.038||95.0|-1.66|-0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Anxiety Score~Pregabalin minus Placebo"||-0.05|-1.66|0.038
91580958|NCT00141219|183051963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.438||0.664||95.0|-1.05|0.67||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Depression Score~Pregabalin minus Placebo"||0.67|-1.05|0.664
91580959|NCT00141219|183051964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance. p-value is from comparing Pregabalin versus Placebo.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.473
91769641|NCT00452790|183426361|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91580960|NCT00141219|183051965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.119
91580961|NCT00662818|183051994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.329|TWO_SIDED|95.0|0.62|4.25|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.25|0.62|0.329
91580962|NCT00662818|183051995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.42|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.50|0.59|0.420
91769642|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91580963|NCT00662818|183051999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.648|TWO_SIDED|95.0|0.52|2.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.85|0.52|0.648
91580964|NCT00662818|183052000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.647|TWO_SIDED|95.0|0.31|2.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.07|0.31|0.647
91580965|NCT00662818|183052001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.201|TWO_SIDED|95.0|0.73|4.6|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.60|0.73|0.201
91580966|NCT00662818|183052002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.579|TWO_SIDED|95.0|0.47|3.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.85|0.47|0.579
91580967|NCT02842151|183052040|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.346|||TWO_SIDED|90.0|-0.03|0.13||||||To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.13|-0.03|
91580968|NCT02842151|183052040|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.595|||TWO_SIDED|90.0|-0.21|0.07||||||To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.07|-0.21|
91580969|NCT02842151|183052040|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.13|STANDARD_DEVIATION|0.34|||TWO_SIDED|90.0|-0.22|-0.04||||||To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.||-0.04|-0.22|
91580970|NCT01781078|183052063|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.3|||<|0.0001|ONE_SIDED|95.0||3.9|||Farrington-Manning score test|||||3.9||<0.0001
91769643|NCT00452790|183426361|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.690
91790128|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0957||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 4||||0.0957
91580971|NCT01781078|183052064|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.1||||0.0006|ONE_SIDED|95.0||5.0|||Farrington-Manning score test|||||5.0||0.0006
91580972|NCT01781078|183052064|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|0.0||||0.0002|ONE_SIDED|95.0||4.7|||Farrington-Manning score test|||||4.7||0.0002
91580973|NCT02217501|183052067|SUPERIORITY|||||||0.6595||||||Alpha of 0.05|Cochran-Mantel-Haenszel|||||||0.6595
91580974|NCT03748992|183052075|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||Non Applicable||Non Applicable||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
91580975|NCT03748992|183052077|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||||||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
91580976|NCT03924765|183052078|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed by setting an alpha value to 0.05.||||||5e-06|||||||ANOVA|||Primary Outcome Measure - Arm/Group 1||||0.000005
91580977|NCT03924765|183052079|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's step length asymmetry by setting an alpha value to 0.05.||||||0.131|||||||ANOVA|||Secondary Outcome Measure - Arm/Group 1||||0.131
91580978|NCT03691909|183052081|OTHER|||||||0.743|||||||Wilcoxon-signed rank test|Effect Size: 0.09||||||0.743
91580979|NCT03691909|183052082|OTHER|||||||0.714|||||||Wilcoxon-signed rank test|Effect Size: 0.10||||||0.714
91580980|NCT03691909|183052083|OTHER|||||||0.183|||||||Wilcoxon-signed rank test|Effect Size: 0.37||||||0.183
91580981|NCT03691909|183052084|OTHER|||||||0.775|||||||Wilcoxon-signed rank test|Effect Size: 0.05||||||0.775
91580982|NCT03691909|183052085|OTHER|||||||0.0008|||||||Wilcoxon-signed rank test|Effect Size: 0.93||Tender Joint Count||||0.0008
91580983|NCT03691909|183052085|OTHER|||||||0.003|||||||Wilcoxon-signed rank test|Effect Size: 0.83||Swollen Joint Count||||0.003
91580984|NCT05038163|183052094|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.63|-0.39|||Regression, Linear|||||-0.39|-0.63|<0.001
91580985|NCT05038163|183052094|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear|||||-0.33|-0.57|<0.001
91580986|NCT05038163|183052094|SUPERIORITY||Treatment Effect|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.24|||Regression, Linear|||||-0.24|-0.44|<0.001
91705891|NCT03300050|183306318|OTHER||Difference|17.9||||0.4421|TWO_SIDED|95.0|-16.24|49.0|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||49.00|-16.24|0.4421
91705892|NCT03300050|183306318|OTHER||Difference|-41.8||||0.0461|TWO_SIDED|95.0|-68.75|-4.8|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||-4.80|-68.75|0.0461
91580987|NCT05038163|183052095|SUPERIORITY||Treatment Effect|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.11|||Regression, Linear|||||-0.11|-0.55|0.003
91580988|NCT05038163|183052095|SUPERIORITY||Treatment Effect|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Regression, Linear|||||-0.35|-0.87|<0.001
91580989|NCT05038163|183052095|SUPERIORITY||Treatment Effect|-0.25|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Regression, Linear|||||-0.17|-0.48|<0.001
91580990|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.67|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.32|-0.67|<0.001
91580991|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.36|-0.70|<0.001
91580992|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.25|-0.57|<0.001
91580993|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.32|-0.65|<0.001
91580994|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.28|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.14|-0.42|<0.001
91769644|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.933
91769645|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.776
91580995|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.57|||<|0.001|TWO_SIDED|95.0|-0.57|-0.27|||Regression, Linear|||Gender subgroup: Male|Unit: $ per 12-pack|-0.27|-0.57|<0.001
91580996|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-2.23|||<|0.001|TWO_SIDED|95.0|-3.34|-1.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-1.12|-3.34|<0.001
91580997|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.69|||<|0.001|TWO_SIDED|95.0|-1.15|-0.23|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.23|-1.15|<0.001
91580998|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
91580999|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.45|||<|0.001|TWO_SIDED|95.0|-0.24|1.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||1.14|-0.24|<0.001
91581000|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.63|-0.37|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.37|-0.63|<0.001
91581001|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.96|||<|0.001|TWO_SIDED|95.0|-1.67|-0.25|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.25|-1.67|<0.001
91581002|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-1.16|0.4|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.40|-1.16|<0.001
91581003|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-1.07|0.19|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||0.19|-1.07|<0.001
91581004|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.54|||<|0.001|TWO_SIDED|95.0|-0.91|-0.17|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.17|-0.91|<0.001
91581005|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.00|0.00|<0.001
91581006|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.16|||<|0.001|TWO_SIDED|95.0|-0.36|0.68|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.68|-0.36|<0.001
91581007|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: white||-0.31|-0.57|<0.001
91581008|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-1.18|||<|0.001|TWO_SIDED|95.0|-2.04|-0.32|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.32|-2.04|<0.001
91581009|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-0.9|0.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.14|-0.90|<0.001
91581010|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.54|-0.04|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-0.04|-1.54|<0.001
91581011|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.9|-0.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.12|-0.90|<0.001
91581012|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Logistic||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
91581013|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.04|||<|0.001|TWO_SIDED|95.0|-0.79|0.71|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.71|-0.79|<0.001
91581014|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.33|||<|0.001|TWO_SIDED|95.0|-0.44|-0.22|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.22|-0.44|<0.001
91581015|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.76|-0.06|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.06|-0.76|<0.001
91581016|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.27|||<|0.001|TWO_SIDED|95.0|-0.85|0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.31|-0.85|<0.001
91581017|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.23|||<|0.001|TWO_SIDED|95.0|-0.45|0.91|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.91|-0.45|<0.001
91581018|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.52|||<|0.001|TWO_SIDED|95.0|-0.65|-0.39|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.39|-0.65|<0.001
91581019|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.93|||<|0.001|TWO_SIDED|95.0|-1.48|-0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.38|-1.48|<0.001
91581020|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.16|||<|0.001|TWO_SIDED|95.0|-0.7|0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.38|-0.70|<0.001
91581021|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.33|-0.57|<0.001
91581022|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.42|-0.16|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.16|-1.42|<0.001
91581023|NCT05038163|183052096|SUPERIORITY||Treatment Effect|0.01||||0.98|TWO_SIDED|95.0|-0.4|0.41|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.41|-0.40|0.980
91581024|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.36|||<|0.001|TWO_SIDED|95.0|-0.47|-0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.25|-0.47|<0.001
91581025|NCT05038163|183052096|SUPERIORITY||Treatment Effect|-0.39|||<|0.001|TWO_SIDED|95.0|-1.03|0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity Subgroup: Other or Prefer Not to Say||0.25|-1.03|<0.001
91581026|NCT05453201|183052098|OTHER|||||||0.06|||||||paired t-test|||This analysis uses the functional disability subscale from pre- to post-intervention.||||.06
91581027|NCT05453201|183052098|OTHER|||||||0.004|||||||paired t-test|||This analysis uses the symptom severity subscale from pre- to post-intervention.||||.004
91581028|NCT05453201|183052098|OTHER|||||||0.1|||||||paired t-test|||This analysis uses the perceived overall health now subscale (1 item) from pre- to post-intervention.||||.10
91705893|NCT03300050|183306322|OTHER||GMT Ratio|1.71||||0.1665|TWO_SIDED|95.0|0.84|3.48|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.48|0.84|0.1665
91705894|NCT03300050|183306322|OTHER||GMT Ratio|1.1||||0.9377|TWO_SIDED|95.0|0.55|2.2|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.20|0.55|0.9377
91705895|NCT03300050|183306322|OTHER||GMT Ratio|0.64||||0.3088|TWO_SIDED|95.0|0.31|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.33|0.31|0.3088
91705896|NCT03300050|183306323|OTHER||Difference|16.3||||0.4667|TWO_SIDED|95.0|-19.85|48.88|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||48.88|-19.85|0.4667
91581029|NCT05453201|183052099|OTHER|||||||0.46|||||||paired t-test|||This analysis uses domain 1 from pre- to post-intervention.||||.46
91705897|NCT03300050|183306323|OTHER||Difference|-1.8|||>|0.9999|TWO_SIDED|95.0|-34.76|32.17|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||32.17|-34.76|>0.9999
91581030|NCT05453201|183052099|OTHER|||||||0.2|||||||paired t-test|||This analysis uses domain 2 from pre- to post-intervention.||||.20
91581031|NCT05453201|183052099|OTHER|||||||0.42|||||||paired t-test|||This analysis uses domain 3 from pre- to post-intervention.||||.42
91581032|NCT05453201|183052099|OTHER|||||||0.84|||||||paired t-test|||This analysis uses domain 4 from pre- to post-intervention.||||.84
91581033|NCT05453201|183052099|OTHER|||||||0.25|||||||paired t-test|||This analysis uses domain 5 (part 1) from pre- to post-intervention.||||.25
91581034|NCT05453201|183052099|OTHER|||||||0.26|||||||paired t-test|||This analysis uses domain 6 from pre- to post-intervention.||||.26
91581035|NCT05453201|183052100|OTHER|||||||0.89|||||||Wilcoxon test|||This analysis uses the SBQ-R total score from pre- to post-intervention.||||.89
91581036|NCT05453201|183052101|OTHER|||||||0.8|||||||paired t-test|||This analysis uses the MOCS (part A) from pre- to post-intervention.||||.80
91581037|NCT05453201|183052102|OTHER|||||||0.92|||||||paired t-test|||This analysis uses the FSCQ score (all items) from pre- to post-intervention.||||.92
91581038|NCT05453201|183052102|OTHER|||||||0.9|||||||Wilcoxon test (paired)|||This analysis uses the FSCQ similarity subscale from pre- to post-intervention.||||.90
91581039|NCT05453201|183052102|OTHER|||||||0.74|||||||paired t-test|||This analysis uses the FSCQ vividness subscale from pre- to post-intervention.||||.74
91581040|NCT05453201|183052102|OTHER|||||||0.44|||||||paired t-test|||This analysis uses the FSCQ positivity subscale from pre- to post-intervention.||||.44
91581041|NCT05453201|183052103|OTHER|||||||0.003|||||||paired t-test|||This analysis uses the PHQ-9 from pre- to post-intervention.||||.003
91581042|NCT05453201|183052104|OTHER|||||||0.01|||||||paired t-test|||This analysis uses the GAD-7 from pre- to post-intervention.||||.01
91581043|NCT05453201|183052105|OTHER|||||||0.04|||||||paired t-test|||This analysis uses the QOLS from pre- to post-intervention.||||.04
91581044|NCT05453201|183052106|OTHER|"The AIM measures an intervention's acceptability. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention acceptability. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the AIM at pre- and post-intervention."||||||0.24|||||||Paired t-test|||||||.24
91581045|NCT05453201|183052106|OTHER|"The IAM measures an intervention's appropriateness. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention appropriateness. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the IAM at pre- and post-intervention."||||||0.82|||||||Paired t-test|||||||.82
91581046|NCT05453201|183052106|OTHER|||||||0.38|||||||Paired t-test|||"The FIM measures an intervention's feasibility. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention feasibility. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the FIM at pre- and post-intervention."||||.38
91581047|NCT04688320|183052135|NON_INFERIORITY|The margin of the non-inferiority was established as a difference in the primary efficacy endpoints between compared groups|Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.11|4.52|||Welch's t-test|||||4.52|0.11|<0.05
91581048|NCT00383110|183052149|SUPERIORITY_OR_OTHER|||||||0.648|||||||ANOVA|||||||0.648
91581049|NCT00383110|183052150|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANOVA|||||||0.14
91581050|NCT00383110|183052151|SUPERIORITY_OR_OTHER|||||||0.675|||||||ANOVA|||||||0.675
91705898|NCT03300050|183306323|OTHER||Difference|-18.1||||0.4495|TWO_SIDED|95.0|-51.15|19.37|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||19.37|-51.15|0.4495
91769646|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.596||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.596
91769647|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.909||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.909
91769648|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.683
91769649|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91769650|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.203
91769651|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.399
91769652|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.382||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.382
91769653|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91581051|NCT00383110|183052152|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
91705899|NCT03300050|183306327|OTHER||GMT Ratio|1.61||||0.0928|TWO_SIDED|95.0|0.94|2.77|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.77|0.94|0.0928
91705900|NCT03300050|183306327|OTHER||GMT Ratio|1.32||||0.4198|TWO_SIDED|95.0|0.77|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.77|0.4198
91769654|NCT00452790|183426362|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Fisher Exact|||Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.738
91769655|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.918||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.918
91769656|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.906
91769657|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.404
91769658|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.305
91769659|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.771
91769660|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91581052|NCT00383110|183052153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91581053|NCT00383110|183052154|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91705901|NCT03300050|183306327|OTHER||GMT Ratio|0.82||||0.6754|TWO_SIDED|95.0|0.47|1.45|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.45|0.47|0.6754
91705902|NCT03300050|183306328|OTHER||Difference|19.2||||0.4515|TWO_SIDED|95.0|-17.19|50.49|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||50.49|-17.19|0.4515
91769661|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.867||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.867
91769662|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.735||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.735
91769663|NCT00452790|183426363|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91769664|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91769665|NCT00452790|183426363|SUPERIORITY_OR_OTHER|||||||0.842||95.0|||||Fisher Exact|||Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.842
91769666|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.908
91769667|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.772
91705903|NCT03300050|183306328|OTHER||Difference|14.3||||0.4837|TWO_SIDED|95.0|-21.22|46.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||46.19|-21.22|0.4837
91705904|NCT03300050|183306328|OTHER||Difference|-4.9|||>|0.9999|TWO_SIDED|95.0|-38.8|30.46|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||30.46|-38.80|>0.9999
91705905|NCT03300050|183306331|OTHER||Difference|2.93||||0.0031|TWO_SIDED|95.0|1.56|7.49|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||7.49|1.56|0.0031
91705906|NCT03300050|183306331|OTHER||Difference|1.25||||0.2048|TWO_SIDED|95.0|0.73|2.23|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||2.23|0.73|0.2048
91769668|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.681
91769669|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.881
91769670|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.509
91769671|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91769672|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.880
91769673|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.739
91769674|NCT00452790|183426364|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91769675|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91769676|NCT00452790|183426364|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.446
91705907|NCT03300050|183306331|OTHER||Difference|0.43||||0.0392|TWO_SIDED|95.0|0.18|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||1.00|0.18|0.0392
91705908|NCT03300050|183306332|OTHER||Difference|1.16||||0.8243|TWO_SIDED|95.0|0.14|4.95|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||4.95|0.14|0.8243
91769677|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.625||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>=38 but \<=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.625
91581054|NCT00910689|183052192|SUPERIORITY_OR_OTHER||||||<|0.01||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family-wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus Test: A mixed model with fixed effects for treatment,natural time(defined as natural log of months) and treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects(using the PROC MIXED procedure in SAS statistical software,version 9;www.sas.com). A significant treatment by time interaction(p \< .05, 2-tailed) was followed by post-tests (see below). Details of significant post tests are reported as separate analyses.||||< .01
91581055|NCT00910689|183052192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|0.57|<|0.001||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581056|NCT00910689|183052192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.68|>|0.25|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .25
91581057|NCT00910689|183052192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59|>|0.98|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .98
91581058|NCT00910689|183052192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581059|NCT00910689|183052192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.61|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
91705909|NCT03300050|183306332|OTHER||Difference|1.74||||0.253|TWO_SIDED|95.0|0.67|6.06|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||6.06|0.67|0.2530
91705910|NCT03300050|183306332|OTHER||Difference|1.83||||0.5654|TWO_SIDED|95.0|0.47|39.92|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||39.92|0.47|0.5654
91705911|NCT03300050|183306336|OTHER||GMT Ratio|1.21||||0.883|TWO_SIDED|95.0|0.45|3.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.27|0.45|0.8830
91705912|NCT03300050|183306336|OTHER||GMT Ratio|0.86||||0.9238|TWO_SIDED|95.0|0.33|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.33|0.9238
91705913|NCT03300050|183306336|OTHER||GMT Ratio|0.71||||0.6926|TWO_SIDED|95.0|0.26|1.97|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.97|0.26|0.6926
91705914|NCT03300050|183306337|OTHER||Difference|11.7||||0.7036|TWO_SIDED|95.0|-25.72|45.82|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||45.82|-25.72|0.7036
91705915|NCT03300050|183306337|OTHER||Difference|-3.8|||>|0.9999|TWO_SIDED|95.0|-37.9|31.31|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||31.31|-37.90|>0.9999
91705916|NCT03300050|183306337|OTHER||Difference|-15.5||||0.6951|TWO_SIDED|95.0|-49.56|22.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||22.79|-49.56|0.6951
91790129|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0752||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 5||||0.0752
91705917|NCT03300050|183306341|OTHER||GMT Ratio|0.65||||0.3203|TWO_SIDED|95.0|0.32|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.33|0.32|0.3203
91705918|NCT03300050|183306341|OTHER||GMT Ratio|0.72||||0.5009|TWO_SIDED|95.0|0.35|1.47|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.47|0.35|0.5009
91705919|NCT03300050|183306341|OTHER||GMT Ratio|1.1||||0.9542|TWO_SIDED|95.0|0.51|2.37|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||2.37|0.51|0.9542
91705920|NCT03300050|183306342|OTHER||Difference|-1.7|||>|0.9999|TWO_SIDED|95.0|-30.62|23.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||23.79|-30.62|>0.9999
91705921|NCT03300050|183306342|OTHER||Difference|6.7|||>|0.9999|TWO_SIDED|95.0|-16.24|30.34|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||30.34|-16.24|>0.9999
91581060|NCT00910689|183052192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.72|>|0.29|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.29
91581061|NCT00910689|183052193|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|95.0||||6 pair wise contrasts were conducted: The first 3 contrasts compared each of the 3 additive treatments to OAT + PL. The 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (PROC MIXED, SAS 9).When the treatment by time interaction was significant (p \< .05, 2-tailed)post-tests were conducted (see below).Details of significant post tests are reported as separate analyses.||||< .03
91581062|NCT00910689|183052193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581063|NCT00910689|183052193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|1.12|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581064|NCT00910689|183052193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_DEVIATION|1.26|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581065|NCT00910689|183052193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.2|>|0.02|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .02
91581066|NCT00910689|183052193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.35|>|0.79||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>.79
91581067|NCT00910689|183052193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.43|>|0.02||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|||Post-test contrast. Mean difference in change.||||>.02
91581068|NCT00910689|183052194|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|95.0||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); three additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure controlled the familywise type I error for the 6 contrasts at .05. Adjusted p=.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction and pretreatment Migraine Specific Quality of Life scores as covariate was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (using the PROC MIXED procedure in SAS statistical software, version 9; www. sas.com).A significant treatment by time interaction (p \< .05, 2-tailed) was followed by post-tests||||<.005
91581069|NCT00910689|183052194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.18|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||< .001
91581070|NCT00910689|183052194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0|STANDARD_DEVIATION|2.41|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91769678|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.375
91790130|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3964||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 6||||0.3964
91581071|NCT00910689|183052194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_DEVIATION|1.67|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||< .001
91581072|NCT00910689|183052194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.9|STANDARD_DEVIATION|2.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
91581073|NCT00910689|183052194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|1.83|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581074|NCT00910689|183052194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|2.38|>|0.87||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.87
91581075|NCT00910689|183052195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
91581076|NCT00910689|183052195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.79|>|0.83|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .83
91581077|NCT00910689|183052195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.67|>|0.05|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .05
91581078|NCT00910689|183052195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.86|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Significant post-test contrast. Mean difference in change.||||< .001
91705922|NCT03300050|183306342|OTHER||Difference|8.3||||0.4615|TWO_SIDED|95.0|-19.94|36.04|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||36.04|-19.94|0.4615
91581079|NCT00910689|183052195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.95|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
91581080|NCT00910689|183052195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.89|>|0.2|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .20
91581081|NCT00910689|183052196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
91581082|NCT00910689|183052196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_DEVIATION|1.96|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
91581083|NCT00910689|183052196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581084|NCT00910689|183052196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.69|>|0.04||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.04
91581085|NCT00910689|183052196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.34|>|0.33||95.0||||Bonerfoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.33
91581086|NCT00910689|183052196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.68|>|0.21||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.21
91581087|NCT00910689|183052197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.4|STANDARD_DEVIATION|3.0|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91581088|NCT00910689|183052197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|3.29|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91769679|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.624||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.624
91581089|NCT00910689|183052197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_DEVIATION|2.99|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
91769680|NCT00452790|183426365|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91769681|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.282
91581090|NCT00910689|183052197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.85|>|0.56||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.56
91581091|NCT00910689|183052197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.45|>|0.08||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.08
91581092|NCT00910689|183052197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|2.83|>|0.03||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.03
91581093|NCT00645801|183052221|SUPERIORITY|||||||0.05||||||A 2-sided 2 sample t test was used to compare the overall cleanliness score between the 2 treatment groups.|t-test, 2 sided|||Based on the assumption that 70% of patients using PEG plus placebo (group 2) will have good results, by allocating 100 cases in each group, we will have 84% power to detect a difference of 18% or more in the effectiveness of PEG plus lubiprostone combination (group 1) (eg, 70% in group 2 vs. 88% in group 1) at the alpha level of significancelevel of significance.||||0.05
91705923|NCT03300050|183306346|OTHER||GMT Ratio|1.2||||0.9164|TWO_SIDED|95.0|0.38|3.8|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.80|0.38|0.9164
91769682|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.307||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.307
91581094|NCT00645801|183052222|SUPERIORITY||||||<|0.05|||||||2 sided Cochran-Armitage trend test|||||||<0.05
91581095|NCT00645801|183052223|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91581096|NCT00759915|183052224|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|109.98||||||90.0|100.1|120.8|||ANOVA|log-transformation||||120.8|100.1|
91581097|NCT00759915|183052226|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|100.91||||||90.0|96.96|105.0|||ANOVA|log-transformation||||105.0|96.96|
91581098|NCT00759915|183052227|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|96.5||||||90.0|92.3|100.97|||ANOVA|log-transformation||||100.97|92.3|
91705924|NCT03300050|183306346|OTHER||GMT Ratio|0.76||||0.8642|TWO_SIDED|95.0|0.21|2.79|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.79|0.21|0.8642
91705925|NCT03300050|183306346|OTHER||GMT Ratio|0.63||||0.6545|TWO_SIDED|95.0|0.18|2.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.27|0.18|0.6545
91705926|NCT03300050|183306347|OTHER||Difference|7.7|||>|0.9999|TWO_SIDED|95.0|-27.1|40.96|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||40.96|-27.10|>0.9999
91769683|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.939||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.939
91769684|NCT00452790|183426365|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
91769685|NCT00452790|183426366|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.111
91769686|NCT00452790|183426366|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91790131|NCT00282464|183459372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Overall||||0.0287
91518218|NCT01986881|182910723|SUPERIORITY||Difference in the least squares means|-0.81||||0.02|TWO_SIDED|95.0|-1.48|-0.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.13|-1.48|0.020
91518219|NCT01986881|182910726|SUPERIORITY||Difference in the Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.07|-1.77|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.77|-2.07|<0.001
91518220|NCT01986881|182910726|SUPERIORITY||Difference in the Least Squares Means|-1.63|||<|0.001|TWO_SIDED|95.0|-1.78|-1.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.47|-1.78|<0.001
91581099|NCT00932113|183052236|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91581100|NCT03310268|183052249|OTHER||Difference of Least Square mean|0.19|STANDARD_ERROR_OF_MEAN|0.094||0.0476|TWO_SIDED|95.0|0.002|0.374|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.374|0.002|0.0476
91581101|NCT03310268|183052249|OTHER||Difference of Least Square mean|-0.02|STANDARD_ERROR_OF_MEAN|0.093||0.8411|TWO_SIDED|95.0|-0.202|0.164|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.164|-0.202|0.8411
91581102|NCT03310268|183052249|OTHER||Difference of Least Square mean|0.21|STANDARD_ERROR_OF_MEAN|0.094||0.0298|TWO_SIDED|95.0|0.02|0.393|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.393|0.020|0.0298
91581103|NCT03310268|183052250|OTHER||Difference of Least Square mean|-7.2|STANDARD_ERROR_OF_MEAN|4.649||0.1232|TWO_SIDED|95.0|-16.376|1.975|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||1.975|-16.376|0.1232
91581104|NCT03310268|183052250|OTHER||Difference of Least Square mean|-4.04|STANDARD_ERROR_OF_MEAN|4.588||0.3793|TWO_SIDED|95.0|-13.099|5.011|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||5.011|-13.099|0.3793
91581105|NCT03310268|183052250|OTHER||Difference of Least Square mean|-3.16|STANDARD_ERROR_OF_MEAN|4.648||0.4979|TWO_SIDED|95.0|-12.33|6.017|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||6.017|-12.330|0.4979
91581106|NCT04797650|183052251|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.25|0.37||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.37|0.25|<0.0001
91581107|NCT04797650|183052251|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.27|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.45|0.27|<0.0001
91705927|NCT03300050|183306347|OTHER||Difference|30.8||||0.1045|TWO_SIDED|95.0|-1.76|58.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||58.19|-1.76|0.1045
91705928|NCT03300050|183306347|OTHER||Difference|23.1||||0.2292|TWO_SIDED|95.0|-8.62|50.86|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||50.86|-8.62|0.2292
91581108|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.31|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.46|0.31|<0.0001
91581109|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.26|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.45|0.26|<0.0001
91769687|NCT00452790|183426366|SUPERIORITY_OR_OTHER|||||||0.488||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.488
91769688|NCT00452790|183426366|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.736
91769689|NCT00452790|183426366|SUPERIORITY_OR_OTHER|||||||0.856||95.0|||||Fisher Exact|||Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.856
91769690|NCT00452790|183426366|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.098
91769691|NCT00452790|183426366|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.034
91769692|NCT00452790|183426366|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91581110|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.3|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.45|0.30|<0.0001
91581111|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.31|0.5||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.50|0.31|<0.0001
91581112|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.46|0.32|<0.0001
91581113|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.41|0.59||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.59|0.41|<0.0001
91581114|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.45|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.38|0.52||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.38|<0.0001
91769693|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
91769694|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91769695|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.489
91769696|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.840
91769697|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||0.605||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.605
91769698|NCT00452790|183426367|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91581115|NCT04797650|183052252|SUPERIORITY||Risk Difference (RD)|0.49|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.4|0.58||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.58|0.40|<0.0001
91581116|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.3175|TWO_SIDED|95.0|0.0|0.01||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.01|-0.00|0.3175
91769699|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.265
91769700|NCT00452790|183426367|SUPERIORITY_OR_OTHER|||||||0.422||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.422
91769701|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.815
91769702|NCT00452790|183426368|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
91769703|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
91581117|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.102|TWO_SIDED|95.0|0.0|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.00|0.1020
91581118|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.3103|TWO_SIDED|95.0|-0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.01|0.3103
91581119|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
91705929|NCT00564278|183306465|SUPERIORITY_OR_OTHER_LEGACY||GEE model Beta|17.46||||0.26|TWO_SIDED|95.0|-16.61|51.53||All analyses presented are at 9 months.|t-test, 2 sided|t(193) = -1.14, p=.26||"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.~We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found."||51.53|-16.61|0.26
91769704|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.401
91769705|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||0.511||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.511
91581120|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.17|0.06|<0.0001
91769706|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.487
91769707|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||0.388||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.388
91769708|NCT00452790|183426368|SUPERIORITY_OR_OTHER|||||||0.753||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.753
91769709|NCT02360228|183426394|OTHER|||||||0.47|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups.H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.47
91581121|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.14|0.24||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.24|0.14|<0.0001
91769710|NCT02360228|183426396|OTHER|||||||0.37|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the PANSS score from day 5 to baseline. H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.37
91790132|NCT00282464|183459373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.965||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.965
91769711|NCT02360228|183426397|OTHER|||||||0.11|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||"The null hypothesis was that there is no difference between the changes in the BACS score from baseline to 5 days between the groups:~H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)"||||0.11
91769712|NCT00383552|183426407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91769713|NCT00383552|183426408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91769714|NCT00383552|183426410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91769715|NCT00383552|183426411|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91769716|NCT00383552|183426412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Longitudinal Model|||||||0.073
91769717|NCT00383552|183426413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||BMI 25 to \<30|ANCOVA|||||||0.015
91518221|NCT01986881|182910727|SUPERIORITY||Difference in the Least Squares Means|-2.45|||<|0.001|TWO_SIDED|95.0|-2.67|-2.24|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.24|-2.67|<0.001
91581122|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.13|0.27||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.27|0.13|<0.0001
91705930|NCT00564278|183306466|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.28|||||TWO_SIDED|95.0|-1.57|1.01||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.|||1.01|-1.57|
91705931|NCT00564278|183306467|SUPERIORITY_OR_OTHER_LEGACY||Work - Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.5|0.95||See under Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.|||0.95|-0.50|
91769718|NCT00383552|183426413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||BMI less than 25 and for BMI 30 or more|ANCOVA|||||||<0.001
91769719|NCT02764385|183426432|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.01||||||||2.01|1.73|
91769720|NCT02764385|183426432|SUPERIORITY||Odds Ratio (OR)|0.68||||0.05|TWO_SIDED|95.0|0.45|1.02|||Regression, Logistic|We adjust for clustering of visit within clinician and clinical site and the stepped wedge study design using generalized estimating equation methods.||||1.02|.45|.05
91769721|NCT02764385|183426433|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.1||||||||2.10|1.73|
91769722|NCT03016312|183426463|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.094|TWO_SIDED|95.0|0.971|1.445|||Log Rank|||Unstratified Analysis||1.445|0.971|0.0940
91769723|NCT03016312|183426463|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.2786|TWO_SIDED|95.0|0.913|1.37|||Log Rank|||Stratified Analysis||1.370|0.913|0.2786
91518222|NCT01986881|182910727|SUPERIORITY||Difference in the Least Squares Means|-2.07|||<|0.001|TWO_SIDED|95.0|-2.28|-1.86|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-2.28|<0.001
91581123|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.18|0.29||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo|Mantel Haenszel|||Week 20||0.29|0.18|<0.0001
91518223|NCT01986881|182910728|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.83|-2.22|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.22|-2.83|<0.001
91705932|NCT00564278|183306467|SUPERIORITY_OR_OTHER_LEGACY||Social-Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.49|0.92||See under Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.|||0.92|-0.49|
91769724|NCT03016312|183426464|SUPERIORITY||Difference in Event Free Rate|-0.2||||0.9391|TWO_SIDED|95.0|-5.38|4.97|||z-test|||Difference in Event Free Rate - 6 months||4.97|-5.38|0.9391
91769725|NCT03016312|183426464|SUPERIORITY||Difference in Event Free Rate|-4.03||||0.2706|TWO_SIDED|95.0|-11.21|3.14|||z-test|||Difference in Event Free Rate - 12 months||3.14|-11.21|0.2706
91769726|NCT03016312|183426466|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.3157|TWO_SIDED|95.0|0.775|1.086|||Log Rank|||Unstratified Analysis||1.086|0.775|0.3157
91769727|NCT03016312|183426466|SUPERIORITY||Hazard Ratio (HR)|0.899||||0.2366|TWO_SIDED|95.0|0.754|1.072|||Log Rank|||Stratified Analysis||1.072|0.754|0.2366
91769728|NCT03016312|183426467|SUPERIORITY||Difference in Event Free Rate|2.21||||0.5959|TWO_SIDED|95.0|-5.95|10.37|||z-test|||Difference in Event Free Rate - 6 months||10.37|-5.95|0.5959
91769729|NCT03016312|183426467|SUPERIORITY||Difference in Event Free Rate|1.44||||0.6262|TWO_SIDED|95.0|-4.35|7.23|||z-test|||Difference in Event Free Rate - 12 months||7.23|-4.35|0.6262
91769730|NCT03016312|183426468|SUPERIORITY||Difference in 50% Decrease Response Rate|1.6|||||TWO_SIDED|2.0|-4.5|7.8|||||||Odds Ratio: 1.1 95%CI: 0.8, 1.5|7.8|-4.5|
91769731|NCT03016312|183426469|SUPERIORITY||Hazard Ratio (HR)|1.055||||0.5359|TWO_SIDED|95.0|0.89|1.251|||Log Rank|||Unstratified Analysis||1.251|0.890|0.5359
91769732|NCT03016312|183426469|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.6857|TWO_SIDED|95.0|0.869|1.238|||Log Rank|||Stratified Analysis||1.238|0.869|0.6857
91769733|NCT02210000|183426481|SUPERIORITY||Median Difference (Net)|-0.212||||0.017|TWO_SIDED|95.0|-0.3716|-0.0448||Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.|Bayesian method|||||-0.0448|-0.3716|0.017
91769734|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.2353|0.6553|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6553|-0.2353|
91581124|NCT04797650|183052253|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.19|0.35||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.35|0.19|<0.0001
91581125|NCT04797650|183052254|SUPERIORITY||Least Square (LS) Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.97||0.0039|TWO_SIDED|95.0|-4.7|-0.9||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-0.9|-4.7|0.0039
91581126|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.12||0.0027|TWO_SIDED|95.0|-5.6|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.2|-5.6|0.0027
91581127|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-13.6|-5.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-5.1|-13.6|<0.0001
91581128|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.47|<|0.0001|TWO_SIDED|95.0|-19.0|-9.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-9.3|-19|<0.0001
91581129|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|2.92|<|0.0001|TWO_SIDED|95.0|-28.8|-17.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-17.3|-28.8|<0.0001
91581130|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|-35.9|-22.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-22.7|-35.9|< 0.0001
91581131|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-34.8|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|-41.4|-28.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-28.2|-41.4|< 0.0001
91581132|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|95.0|-47.8|-32.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-32.6|-47.8|< 0.0001
91769735|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.749|||||TWO_SIDED|95.0|0.2275|1.2705|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.2705|0.2275|
91769736|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.489|||||TWO_SIDED|95.0|-0.0592|1.0374|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.0374|-0.0592|
91581133|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|-45.9|-31.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-31.6|-45.9|< 0.0001
91581134|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-46.6|STANDARD_ERROR_OF_MEAN|4.17|<|0.0001|TWO_SIDED|95.0|-54.8|-38.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-38.4|-54.8|< 0.0001
91581135|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-53.4|-38.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-38.5|-53.4|< 0.0001
91581136|NCT04797650|183052254|SUPERIORITY||LS Mean Difference|-52.8|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-61.4|-44.2|||MMRM|||Week 24||-44.2|-61.4|< 0.0001
91581137|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
91581138|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
91581139|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
91769737|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.497|||||TWO_SIDED|95.0|0.0396|0.955|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9550|0.0396|
91769738|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.3386|0.4395|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.4395|-0.3386|
91769739|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|-0.038|||||TWO_SIDED|95.0|-0.3242|0.2492|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.2492|-0.3242|
91581140|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
91581141|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
91581142|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
91581143|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
91581144|NCT04797650|183052255|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
91581145|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
91581146|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
91581147|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
91581148|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
91581149|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
91581150|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
91581151|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
91581152|NCT04797650|183052256|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
91581153|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.5|< 0.0001
91581154|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-1.7|< 0.0001
91581155|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|< 0.0001
91769740|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.0483|0.9978|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9978|-0.0483|
91581156|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.2|-1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.5|-2.2|< 0.0001
91581157|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2|< 0.0001
91581158|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.7|-2.5|< 0.0001
91581159|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.5|< 0.0001
91581160|NCT04797650|183052257|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-2.8|-2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-2|-2.8|< 0.0001
91581161|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.8|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.8|< 0.0001
91581162|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-2|< 0.0001
91581163|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.2|-2|< 0.0001
91581164|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.3|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.3|< 0.0001
91581165|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.2|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2.2|< 0.0001
91581166|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.4|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.4|< 0.0001
91581167|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|< 0.0001
91581168|NCT04797650|183052258|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.8|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.8|< 0.0001
91581169|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.05|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.05|< 0.0001
91581170|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.17|0.06|< 0.0001
91705933|NCT00564278|183306467|SUPERIORITY_OR_OTHER_LEGACY||Family-Mixed Model Beta for MADT vs SADT|0.55|||||TWO_SIDED|95.0|-0.08|1.18||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.|||1.18|-0.08|
91705934|NCT00564278|183306468|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|0.02|||||TWO_SIDED|95.0|-3.61|3.64||See Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.|||3.64|-3.61|
91769741|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.461|||||TWO_SIDED|95.0|-0.0519|0.9748|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9748|-0.0519|
91769742|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.536|||||TWO_SIDED|95.0|0.0967|0.9745|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9745|0.0967|
91769743|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.196|||||TWO_SIDED|95.0|-0.2746|0.6671|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6671|-0.2746|
91769744|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.314|||||TWO_SIDED|95.0|-0.2013|0.8292|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.8292|-0.2013|
91769745|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.384|||||TWO_SIDED|95.0|-0.0323|0.7997|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7997|-0.0323|
91769746|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.068|||||TWO_SIDED|95.0|-0.2366|0.3723|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.3723|-0.2366|
91769747|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.548|||||TWO_SIDED|95.0|0.1333|0.9628|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9628|0.1333|
91769748|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.479|||||TWO_SIDED|95.0|-0.0386|0.9966|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9966|-0.0386|
91769749|NCT02210000|183426482|SUPERIORITY||Mean Difference (Net)|0.356|||||TWO_SIDED|95.0|-0.0049|0.7179|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7179|-0.0049|
91769750|NCT00833040|183426490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.3|STANDARD_ERROR_OF_MEAN|4.49|<|0.001||95.0|||||ANCOVA|||difference between the active and placebo groups||||<0.001
91705935|NCT00564278|183306469|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.04|||||TWO_SIDED|95.0|-0.74|0.66||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.|||0.66|-0.74|
91581171|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.27|0.38||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.38|0.27|< 0.0001
91581172|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.28|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.28|< 0.0001
91705936|NCT00564278|183306470|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|9.14|||||TWO_SIDED|95.0|2.71|15.57||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.|||15.57|2.71|
91705937|NCT03077607|183306476|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|139.92|||||TWO_SIDED|90.0|113.26|172.87||||||Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)||172.87|113.26|
91705938|NCT03077607|183306477|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|150.71|||||TWO_SIDED|90.0|136.47|166.43||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||166.43|136.47|
91705939|NCT03077607|183306478|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|156.24|||||TWO_SIDED|90.0|137.58|177.42||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||177.42|137.58|
91705940|NCT03077607|183306479|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|136.62|||||TWO_SIDED|90.0|103.2|180.87||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||180.87|103.20|
91705941|NCT03077607|183306480|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|105.37|||||TWO_SIDED|90.0|98.04|113.24||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||113.24|98.04|
91769751|NCT00904813|183426505|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.38||||0.52|TWO_SIDED|90.0|0.06|2.56||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group. Estimation described above is for SRT-delay. For LRT-delay HR (90% CI) was 1.22 with lower limit: 0.33, and upper limit: 3.45.|The effect of treatment regimen on local recurrence as first event in the three-armed group comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||2.56|0.06|0.52
91581173|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0409|TWO_SIDED|95.0|0.0|0.03||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.03|0.00|0.0409
91705942|NCT03077607|183306481|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|102.04|||||TWO_SIDED|90.0|94.02|110.74||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||110.74|94.02|
91705943|NCT04401202|183306501|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91705944|NCT04165135|183306567|OTHER|||||||0.763|||||||Kruskal-Wallis|||Heart zone minutes: Comparison among the age groups was performed by means of a Kruskal-Wallis test.||||0.7630
91705945|NCT04165135|183306567|OTHER|||||||0.0913|||||||Kruskal-Wallis|||Active zone minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0913
91705946|NCT04165135|183306567|OTHER|||||||0.0956|||||||Kruskal-Wallis|||MVPA minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0956
91705947|NCT04165135|183306568|OTHER|||||||0.0649|||||||Kruskal-Wallis|||||||0.0649
91705948|NCT04165135|183306569|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
91769752|NCT00904813|183426505|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.93||||0.92|TWO_SIDED|95.0|0.64|1.35||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group (1.00). Estimation described above is for SRT-delay. For LRT-delay HR (95% CI) was 0.99 with lower limit: 0.68, and upper limit: 1.42.|The effect of treatment regimen on recurrence-free survival in the three armed randomisation comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||1.35|0.64|0.92
91769753|NCT00904813|183426505|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.91||||0.59|TWO_SIDED|90.0|0.36|2.27||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group (1.00). Estimation described above is for SRT-delay.|The effect of treatment regimen on local recurrence as first event in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||2.27|0.36|0.59
91769754|NCT00904813|183426505|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.9||||0.39|TWO_SIDED|95.0|0.69|1.18||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group. Estimation described above is for SRT-delay.|The effect of treatment regimen on recurrence-free survival in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||1.18|0.69|0.39
91769755|NCT00904813|183426506|SUPERIORITY||Odds Ratio (OR)|0.72||||0.289|TWO_SIDED|95.0|0.4|1.32||The threshold of statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||1.32|0.40|0.289
91769756|NCT00904813|183426506|SUPERIORITY||Odds Ratio (OR)|0.5||||0.009|TWO_SIDED|95.0|0.3|0.84||The threshold for statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.84|0.30|0.009
91518224|NCT01986881|182910728|SUPERIORITY||Difference in the Least Squares Means|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.83|-2.39|<0.001
91581174|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.012|TWO_SIDED|95.0|0.01|0.09||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.09|0.01|0.012
91705949|NCT04165135|183306570|OTHER|||||||0.9493|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9493
91705950|NCT04165135|183306570|OTHER|||||||0.8305|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8305
91705951|NCT04165135|183306570|OTHER|||||||0.8725|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8725
91769757|NCT00904813|183426506|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.65||The threshold for statistical significance was p-value=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.65|0.23|<0.001
91518225|NCT01986881|182910730|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.97|-2.1|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-2.97|<0.001
91518226|NCT01986881|182910730|SUPERIORITY||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-2.52|-1.68|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.68|-2.52|<0.001
91581175|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.16|0.26||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.26|0.16|< 0.0001
91581176|NCT04797650|183052259|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.16|0.31||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.31|0.16|< 0.0001
91705952|NCT04165135|183306570|OTHER|||||||0.338|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3380
91705953|NCT04165135|183306570|OTHER|||||||0.9706|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9706
91705954|NCT04165135|183306570|OTHER|||||||0.1727|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1727
91705955|NCT04165135|183306570|OTHER|||||||0.0099|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0099
91705956|NCT04165135|183306571|OTHER|||||||0.6151|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.6151
91705957|NCT04165135|183306571|OTHER|||||||0.9332|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9332
91705958|NCT04165135|183306571|OTHER|||||||0.4726|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4726
91769758|NCT00904813|183426506|SUPERIORITY||Odds Ratio (OR)|1.58||||0.521|TWO_SIDED|95.0|0.39|6.37||The threshold for statistical significance was p-value = 0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group E was used as the reference group.|The association between postoperative complications and long-course RT by overall treatment time was assessed using logistic regression analysis.||6.37|0.39|0.521
91769759|NCT00904813|183426507|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.046|TWO_SIDED|95.0|0.26|0.99||The threshold for statistical significance was p=0.05.|Regression, Cox|Model adjusted for age, sex and type of surgery.|No pCR was used as reference group.|The association between pathological complete response (pCR), eg no signs of viable tumour or metastatic nodes (T0N0) and overall survival (OS) was assessed using Cox-regression model.||0.99|0.26|0.046
91518227|NCT01986881|182910733|SUPERIORITY||Difference in the Lease Squares Means|-1.78|||||TWO_SIDED|95.0|-2.41|-1.15|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-1.15|-2.41|
91581177|NCT04797650|183052260|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|0.7|1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.4|0.7|< 0.0001
91705959|NCT04165135|183306571|OTHER|||||||0.4111|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4111
91705960|NCT04165135|183306571|OTHER|||||||0.0892|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0892
91705961|NCT04165135|183306571|OTHER|||||||0.1642|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1642
91518228|NCT01986881|182910733|SUPERIORITY||Difference in the Least Squares Means|-1.19|||||TWO_SIDED|95.0|-1.82|-0.56|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.56|-1.82|
91518229|NCT01986881|182910734|SUPERIORITY||Difference in the Lease Squares Means|-0.88|||||TWO_SIDED|95.0|-1.58|-0.18|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.18|-1.58|
91705962|NCT04165135|183306571|OTHER|||||||0.7256|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.7256
91705963|NCT04165135|183306572|OTHER|||||||0.0745|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0745
91705964|NCT04165135|183306572|OTHER|||||||0.2177|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2177
91705965|NCT04165135|183306572|OTHER|||||||0.2121|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2121
91769760|NCT01755234|183426529|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
91769761|NCT01755234|183426530|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
91769762|NCT01755234|183426531|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.96
91769763|NCT01755234|183426532|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.84
91769764|NCT04663321|183426618|SUPERIORITY|Difference in LS Means|LS Mean Difference|3.3||||0.168|TWO_SIDED|95.0|-1.4|8.0|||ANCOVA|||||8.0|-1.4|0.168
91769765|NCT04663321|183426618|SUPERIORITY|Difference in LS Means|LS Mean Difference|-1.1||||0.697|TWO_SIDED|95.0|-6.9|4.7|||ANCOVA|||||4.7|-6.9|0.697
91769766|NCT04663321|183426619|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.9||||0.124|TWO_SIDED|95.0|-0.8|6.6|||ANCOVA|||||6.6|-0.8|0.124
91769767|NCT04663321|183426619|SUPERIORITY|Difference in LS Means|LS Mean Difference|1.9||||0.417|TWO_SIDED|95.0|-2.7|6.4|||ANCOVA|||||6.4|-2.7|0.417
91769768|NCT04663321|183426622|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.0||||0.187|TWO_SIDED|95.0|-1.0|5.1|||ANCOVA|||||5.1|-1.0|0.187
91769769|NCT04663321|183426622|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.6||||0.738|TWO_SIDED|95.0|-4.3|3.1|||ANCOVA|||||3.1|-4.3|0.738
91769770|NCT04663321|183426623|SUPERIORITY|Difference in LS means|LS Mean Difference|1.7||||0.182|TWO_SIDED|95.0|-0.8|4.3|||ANCOVA|||||4.3|-0.8|0.182
91769771|NCT04663321|183426624|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.1||||0.63|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.630
91769772|NCT04663321|183426624|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.2||||0.549|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.549
91769773|NCT04663321|183426625|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.4||||0.062|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||||0.8|-0.0|0.062
91769774|NCT04663321|183426625|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.0||||0.878|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.878
91769775|NCT05108246|183426627|SUPERIORITY|||||||0.001||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.001
91769776|NCT05108246|183426627|SUPERIORITY|||||||0.003||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.003
91769777|NCT04862065|183426686|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
91769778|NCT04862065|183426687|OTHER|95% Confidence Interval provided|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
91769779|NCT04862065|183426688|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
91769780|NCT00718510|183426690|OTHER||||||<|0.05||||||General Psychopathology Subscale Score|ANOVA|F(1,11)=5.03||Null hypothesis is that there was no difference in change of PANSS between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time). A sample size of 14 patients was needed to give 90% power to detect a 4 point difference on the PANSS. This included a drop-out rate of about 10%.||||<0.05
91769781|NCT00718510|183426691|OTHER|||||||0.46|||||||ANOVA|||Null hypothesis is that there was no difference in change of CGI ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.46
91769782|NCT00718510|183426692|OTHER|||||||0.55|||||||ANOVA|||Null hypothesis is that there was no difference in change of CDSS ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.55
91581178|NCT04797650|183052260|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
91581179|NCT04797650|183052260|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|1.1|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||1.8|1.1|< 0.0001
91581180|NCT04797650|183052260|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|1.3|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.3|< 0.0001
91581181|NCT04797650|183052261|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
91581182|NCT04797650|183052261|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.7|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.7|< 0.0001
91705966|NCT04165135|183306572|OTHER|||||||0.2336|||||||Kruskal-Wallis|||Gym weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2336
91581183|NCT04797650|183052261|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2|1|< 0.0001
91705967|NCT04165135|183306572|OTHER|||||||0.419|||||||Kruskal-Wallis|||Exercises at intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4190
91705968|NCT04165135|183306572|OTHER|||||||0.0252|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0252
91769783|NCT00423657|183426695|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than -10%.|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.8|5.0|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||5.0|-5.8|
91769784|NCT04664153|183426711|SUPERIORITY||Mean Difference (Final Values)|-39.4|STANDARD_ERROR_OF_MEAN|11.74||0.0004|TWO_SIDED|90.0|-58.76|-20.12|||t-test, 1 sided|||||-20.12|-58.76|0.0004
91769785|NCT04664153|183426712|SUPERIORITY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|90.0|-7.02|-2.77|||t-test, 1 sided|||||-2.77|-7.02|<0.0001
91769786|NCT00474123|183426744|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.3
91790133|NCT00282464|183459374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.860
91581184|NCT04797650|183052261|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|1.0|2.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.1|1|< 0.0001
91581185|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.4|< 0.0001
91705969|NCT04165135|183306572|OTHER|||||||0.2143|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2143
91581186|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.5|< 0.0001
91705970|NCT04165135|183306573|OTHER|||||||0.0085|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0085
91705971|NCT04165135|183306573|OTHER|||||||0.1098|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1098
91705972|NCT04165135|183306573|OTHER|||||||0.2703|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2703
91769787|NCT00474123|183426745|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.65
91769788|NCT00474123|183426746|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.02
91769789|NCT00474123|183426747|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.85
91769790|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049||||0.7239|TWO_SIDED|90.0|-0.288|0.19|||Mixed Model Repeated Measure|||Week 1||0.190|-0.288|0.7239
91769791|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018||||0.8351|TWO_SIDED|90.0|-0.127|0.163|||Mixed Model Repeated Measure|||Week 2||0.163|-0.127|0.8351
91581187|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
91581188|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.2|-1.8|< 0.0001
91769792|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.4541|TWO_SIDED|90.0|-0.287|0.11|||Mixed Model Repeated Measure|||Week 3||0.110|-0.287|0.4541
91769793|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.4148|TWO_SIDED|90.0|-0.272|0.093|||Mixed Model Repeated Measure|||Week 4||0.093|-0.272|0.4148
91769794|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.3887|TWO_SIDED|90.0|-0.082|0.254|||Mixed Model Repeated Measure|||Week 5||0.254|-0.082|0.3887
91769795|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195||||0.2594|TWO_SIDED|90.0|-0.093|0.484|||Mixed Model Repeated Measure|||Week 6||0.484|-0.093|0.2594
91769796|NCT01009060|183426761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.4778|TWO_SIDED|90.0|-0.139|0.344|||Mixed Model Repeated Measure|||Week 7||0.344|-0.139|0.4778
91518230|NCT01986881|182910734|SUPERIORITY||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.91|0.49|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.91|
91581189|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.1|-1.6|< 0.0001
91581190|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.4|-2|< 0.0001
91769797|NCT01009060|183426762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737||||0.6947|TWO_SIDED|90.0|-3.884|2.409|||ANCOVA|||||2.409|-3.884|0.6947
91769798|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.252||||0.1399|TWO_SIDED|90.0|-0.535|0.03|||Mixed Model Repeated Measure||For Speed of Processing/Simple Reaction Time|||0.030|-0.535|0.1399
91769799|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179||||0.3992|TWO_SIDED|90.0|-0.176|0.534|||Mixed Model Repeated Measure||For Attention/Vigilance|||0.534|-0.176|0.3992
91769800|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.391||||0.1547|TWO_SIDED|90.0|-0.063|0.845|||Mixed Model Repeated Measure||For Working Memory|||0.845|-0.063|0.1547
91581191|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
91769801|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.279||||0.2531|TWO_SIDED|90.0|-0.127|0.685|||Mixed Model Repeated Measure||For Visual Learning|||0.685|-0.127|0.2531
91769802|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.398||||0.2417|TWO_SIDED|90.0|-0.167|0.963|||Mixed Model Repeated Measure||For Verbal Learning|||0.963|-0.167|0.2417
91769803|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177||||0.2069|TWO_SIDED|90.0|-0.055|0.409|||Mixed Model Repeated Measure||For Reasoning/Problem Solving|||0.409|-0.055|0.2069
91769804|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8645|TWO_SIDED|90.0|-0.262|0.322|||Mixed Model Repeated Measure||For Social Cognition|||0.322|-0.262|0.8645
91769805|NCT01009060|183426763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.7873|TWO_SIDED|90.0|-0.364|0.503|||Mixed Model Repeated Measure||For Working Memory (Two-Back Memory)|||0.503|-0.364|0.7873
91769806|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.024||||0.0225|TWO_SIDED|90.0|-6.872|-1.175|||ANCOVA||For Speed of Processing|||-1.175|-6.872|0.0225
91518231|NCT01986881|182910735|SUPERIORITY||Difference in the least squares means|0.25|||||TWO_SIDED|95.0|-0.59|1.08|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.08|-0.59|
91581192|NCT04797650|183052262|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.4|-2.1|< 0.0001
91705973|NCT04165135|183306573|OTHER|||||||0.3366|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3366
91769807|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.24||||0.3317|TWO_SIDED|95.0|-6.085|1.605|||ANCOVA||For Attention/Vigilance|||1.605|-6.085|0.3317
91769808|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.038||||0.3243|TWO_SIDED|90.0|-5.482|1.406|||ANCOVA||For Working Memory|||1.406|-5.482|0.3243
91769809|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.746||||0.7497|TWO_SIDED|90.0|-4.667|3.175|||ANCOVA||For Visual Learning|||3.175|-4.667|0.7497
91518232|NCT01986881|182910735|SUPERIORITY||Difference in the least squares means|1.12|||||TWO_SIDED|95.0|0.28|1.95|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.95|0.28|
91581193|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|0.25|0.43||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.25|< 0.0001
91581194|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|0.33|0.54||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.54|0.33|< 0.0001
91581195|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|< 0.0001
91581196|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.37|0.57||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.57|0.37|< 0.0001
91705974|NCT04165135|183306573|OTHER|||||||0.0992|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0992
91769810|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.112||||0.1585|TWO_SIDED|90.0|-0.537|6.761|||ANCOVA||For Verbal Learning|||6.761|-0.537|0.1585
91581197|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.34|0.5||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.5|0.34|< 0.0001
91581198|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.54|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.44|0.63||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.63|0.44|< 0.0001
91581199|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.36|0.52||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.36|< 0.0001
91581200|NCT04797650|183052263|SUPERIORITY||Risk Difference (RD)|0.52|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.42|0.62||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.62|0.42|< 0.0001
91705975|NCT04165135|183306573|OTHER|||||||0.1194|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1194
91769811|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.972||||0.6582|TWO_SIDED|90.0|-2.709|4.654|||ANCOVA||For Reasoning and Problem Solving|||4.654|-2.709|0.6582
91769812|NCT01009060|183426764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.338||||0.9092|TWO_SIDED|90.0|-5.316|4.639|||ANCOVA||For Social Cognition|||4.639|-5.316|0.9092
91769813|NCT01009060|183426765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.024||||0.4406|TWO_SIDED|90.0|-3.237|1.19|||Mixed Model Repeated Measure|||||1.190|-3.237|0.4406
91769814|NCT01009060|183426766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.876||||0.5197|TWO_SIDED|90.0|-6.743|2.99|||Mixed Model Repeated Measure|||||2.990|-6.743|0.5197
91769815|NCT01009060|183426767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.824||||0.4637|TWO_SIDED|90.0|-2.334|5.982|||Mixed Model Repeated Measure|||||5.982|-2.334|0.4637
91769816|NCT03349723|183426794|OTHER||Slope|0.9806|STANDARD_ERROR_OF_MEAN|0.0322|||TWO_SIDED|95.0|0.9155|1.0457|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0457|0.9155|
91769817|NCT03349723|183426795|OTHER||Slope|0.9892|STANDARD_ERROR_OF_MEAN|0.0339|||TWO_SIDED|95.0|0.9207|1.0577|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0577|0.9207|
91769818|NCT03409796|183426800|OTHER|||||||0.385|||||||t-test, 1 sided|||Gluten 3 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdBaseline (B) and Vh:Cd15.||||0.385
91705976|NCT04165135|183306573|OTHER|||||||0.0549|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0549
91518233|NCT01986881|182910737|SUPERIORITY||Difference in the Lease Squares Means|1.48|||||TWO_SIDED|95.0|0.31|2.66|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.66|0.31|
91518234|NCT01986881|182910737|SUPERIORITY||Difference in the Least Squares Means|1.66|||||TWO_SIDED|95.0|0.49|2.84|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.84|0.49|
91705977|NCT04165135|183306574|OTHER|||||||0.0088|||||||Chi-squared|||Comparison among age groups was performed using Chi-squared test.||||0.0088
91769819|NCT03409796|183426800|OTHER|||||||0.003|||||||t-test, 1 sided|||Gluten 10 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdB and Vh:Cd15.||||0.003
91769820|NCT03409796|183426801|OTHER|||||||0.01|||||||Poisson distribution|||Gluten 3 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson generalized linear mixed models (GLMM) was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.010
91769821|NCT03409796|183426801|OTHER|||||||0.006|||||||Poisson distribution|||Gluten 10 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson GLMM was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.006
91769822|NCT00770653|183426814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA|||Null hypothesis (H0) = mean increase of HDL after 24 weeks of treatment of Pio/Met group ≤ the mean increase in the Gli/Met group. Alternate hypothesis (H1) = mean increase of HDL after 24 weeks of treatment of Pio/Met group \> the mean increase in the Gli/Met group. The relevant clinical effect size to detect with adequate power was 0.35. With this assumption, a one sided t-test with a type I error rate had 80% power to reject the H0 for the H1 when the sample size was 130 patients per group.||5.3076|1.2264|0.0018
91769823|NCT00770653|183426815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA||Deviation from the normal distribution assumption was detected for original and rank-transformed data for all time-points due to p-value of Shapiro-Wilk test, indicating the normal distribution assumption might be distrusted for HDL-cholesterol data.|||5.3076|1.2264|0.0018
91518235|NCT01986881|182910761|SUPERIORITY||Difference in % vs Placebo|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||||Miettinen \& Nurminen method|0.9|-2.8|
91518236|NCT01986881|182910761|SUPERIORITY||Difference in % vs Placebo|0.3|||||TWO_SIDED|95.0|-1.6|2.1|||||||Miettinen \& Nurminen method|2.1|-1.6|
91581201|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.2|< 0.0001
91769824|NCT00770653|183426816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1311||||0.1167|TWO_SIDED|95.0|-0.2951|0.0329|||ANCOVA|||||0.0329|-0.2951|0.1167
91769825|NCT00770653|183426817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9479||||0.1012|TWO_SIDED|95.0|-39.4331|3.5373|||ANCOVA|||||3.5373|-39.4331|0.1012
91769826|NCT00770653|183426818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1292||||0.7486|TWO_SIDED|95.0|-17.0109|23.2693|||ANCOVA|||||23.2693|-17.0109|0.7486
91769827|NCT00770653|183426819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2355||||0.9464|TWO_SIDED|95.0|-7.1253|6.6543|||ANCOVA|||||6.6543|-7.1253|0.9464
91769828|NCT00770653|183426820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1574||||0.0807|TWO_SIDED|95.0|-0.0193|0.3341|||ANCOVA|||||0.3341|-0.0193|0.0807
91581202|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.4|< 0.0001
91769829|NCT00770653|183426821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5039|||<|0.0001|TWO_SIDED|95.0|-6.4222|-2.5855|||ANCOVA|||||-2.5855|-6.4222|<.0001
91769830|NCT00770653|183426822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0707||||0.7799|TWO_SIDED|95.0|-6.4665|8.6079|||ANCOVA|||||8.6079|-6.4665|0.7799
91769831|NCT00770653|183426823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3161|||<|0.0001|TWO_SIDED|95.0|5.0994|7.5329|||ANCOVA|||||7.5329|5.0994|<.0001
91769832|NCT00770653|183426824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8323||||0.4131|TWO_SIDED|95.0|-2.8312|1.1665|||ANCOVA|||||1.1665|-2.8312|0.4131
91769833|NCT00770653|183426825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8847|||<|0.0001|TWO_SIDED|95.0|-1.3067|-0.4627|||ANCOVA|||||-0.4627|-1.3067|<.0001
91769834|NCT00770653|183426826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4903||||0.0929|TWO_SIDED|95.0|-5.3979|0.4172|||ANCOVA|||||0.4172|-5.3979|0.0929
91769835|NCT00770653|183426827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8832||||0.3279|TWO_SIDED|95.0|-2.6571|0.8906|||ANCOVA|||||0.8906|-2.6571|0.3279
91769836|NCT00770653|183426828|SUPERIORITY_OR_OTHER||Fisher Exact|-3.33||||0.2895|TWO_SIDED|95.0|-14.83|8.39|||Fisher Exact|||The number and percentage of participants with a calculated compliance \>80% and \<120% are presented for both treatment groups. In addition, the p-values of Fisher's exact test, the two-sided 95% confidence intervals for the percentage of patients per treatment group and for the difference between the treatment groups are provided.||8.39|-14.83|0.2895
91581203|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.9|-1.3|< 0.0001
91518237|NCT01986881|182910762|SUPERIORITY||Difference in % vs Placebo|1.3|||||TWO_SIDED|95.0|-5.8|8.4|||||||Miettinen \& Nurminen method|8.4|-5.8|
91518238|NCT01986881|182910762|SUPERIORITY||Difference in % vs Placebo|-1.9|||||TWO_SIDED|95.0|-9.2|5.4|||||||Miettinen \& Nurminen method|5.4|-9.2|
91518239|NCT01986881|182910763|SUPERIORITY||Difference in % vs Placebo|1.4|||||TWO_SIDED|95.0|-17.7|20.4|||||||Miettinen and Nurminen method|20.4|-17.7|
91518240|NCT01986881|182910763|SUPERIORITY||Difference in % vs Placebo|-19.9|||||TWO_SIDED|95.0|-37.5|-1.2|||||||Miettinen and Nurminen method|-1.2|-37.5|
91518241|NCT01986881|182910764|SUPERIORITY||Difference in % vs Placebo|7.9|||||TWO_SIDED|95.0|-5.1|20.5|||||||Based on Miettinen and Nurminen method|20.5|-5.1|
91518242|NCT01986881|182910764|SUPERIORITY||Difference in % vs Placebo|1.0|||||TWO_SIDED|95.0|-12.3|14.2|||||||Miettinen and Nurminen method|14.2|-12.3|
91581204|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.1|-1.6|< 0.0001
91581205|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1|-1.5|< 0.0001
91769837|NCT00770653|183426829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9516||||0.3517|TWO_SIDED|95.0|-94.1999|34.2967|||ANCOVA|||||34.2967|-94.1999|0.3517
91769838|NCT00770653|183426830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-151.4477||||0.1979|TWO_SIDED|95.0|-386.2256|83.3302|||ANCOVA|||||83.3302|-386.2256|0.1979
91769839|NCT00770653|183426831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.8589||||0.7186|TWO_SIDED|95.0|-163.3229|113.6052|||ANCOVA|||||113.6052|-163.3229|0.7186
91769840|NCT00770653|183426832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9728||||0.5058|TWO_SIDED|95.0|-39.9915|20.0459|||ANCOVA|||||20.0459|-39.9915|0.5058
91769841|NCT00770653|183426833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3988||||0.523|TWO_SIDED|95.0|-60.7193|117.5169|||ANCOVA|||||117.5169|-60.7193|0.5230
91581206|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.3|-1.9|< 0.0001
91581207|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.1|-1.6|< 0.0001
91581208|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.8|< 0.0001
91581209|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.7|-1.1|< 0.0001
91581210|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.8|-1.3|< 0.0001
91581211|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.7|-1.2|< 0.0001
91705978|NCT03714776|183306641|SUPERIORITY||||||<|0.001||||||P-value of analysis of variance (ANOVA) with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||||||<0.001
91769842|NCT00770653|183426834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-367.2639||||0.2203|TWO_SIDED|95.0|-964.3923|229.8646|||ANCOVA|||||229.8646|-964.3923|0.2203
91769843|NCT00770653|183426835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0794||||0.585|TWO_SIDED|95.0|-95.6468|151.8057|||ANCOVA|||||151.8057|-95.6468|0.5850
91769844|NCT00770653|183426836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4205||||0.0138|TWO_SIDED|95.0|-4.3207|-0.5202|||ANCOVA|||||-0.5202|-4.3207|0.0138
91769845|NCT00770653|183426837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0009||||0.0817|TWO_SIDED|95.0|-30.1139|1.8578|||ANCOVA|||||1.8578|-30.1139|0.0817
91769846|NCT00770653|183426838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9935||||0.1761|TWO_SIDED|95.0|-0.4843|2.4712|||ANCOVA|||||2.4712|-0.4843|0.1761
91769847|NCT00770653|183426839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5263||||0.0002|TWO_SIDED|95.0|1.3832|3.6695|||ANCOVA|||||3.6695|1.3832|0.0002
91769848|NCT00770653|183426840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2345||||0.0055|TWO_SIDED|95.0|1.0675|5.4016|||ANCOVA|||||5.4016|1.0675|0.0055
91518243|NCT01986881|182910766|SUPERIORITY||Difference in % vs Placebo|0.0|||||TWO_SIDED|95.0|-2.9|3.0|||||||Miettinen \& Nurminen method|3.0|-2.9|
91518244|NCT01986881|182910766|SUPERIORITY||Difference in % vs Placebo|-1.2|||||TWO_SIDED|95.0|-4.0|1.6|||||||Miettinen \& Nurminen method|1.6|-4.0|
91518245|NCT01986881|182910769|SUPERIORITY||Difference in the Least Squares Means|-25.4|||<|0.001|TWO_SIDED|95.0|-32.84|-17.96|||CLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-17.96|-32.84|<0.001
91769849|NCT00770653|183426841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9712||||0.0264|TWO_SIDED|95.0|0.3863|5.5562|||ANCOVA|||||5.5562|0.3863|0.0264
91769850|NCT00770653|183426842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5394||||0.0509|TWO_SIDED|95.0|-0.0114|5.0901|||ANCOVA|||||5.0901|-0.0114|0.0509
91769851|NCT00770653|183426843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1718||||0.1013|TWO_SIDED|95.0|-0.466|4.8097|||ANCOVA|||||4.8097|-0.4660|0.1013
91769852|NCT00770653|183426844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1346||||0.1363|TWO_SIDED|95.0|-0.7338|5.0031|||ANCOVA|||||5.0031|-0.7338|0.1363
91769853|NCT00770653|183426845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4181||||0.1165|TWO_SIDED|95.0|-0.6561|5.4922|||ANCOVA|||||5.4922|-0.6561|0.1165
91769854|NCT01908426|183426858|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0049|TWO_SIDED|95.0|0.63|0.92|||Log Rank|The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.92|0.63|0.0049
91518246|NCT01986881|182910769|SUPERIORITY||Difference in the Least Squares Means|-19.24|||<|0.001|TWO_SIDED|95.0|-26.8|-11.68|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-11.68|-26.80|<0.001
91518247|NCT01986881|182910770|SUPERIORITY||Difference in the Least Squares Means|-1.88|||<|0.001|TWO_SIDED|95.0|-2.37|-1.13|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.37|<0.001
91769855|NCT01908426|183426859|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.36|0.52|||Log Rank|The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.52|0.36|< 0.0001
91581212|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.9|-1.4|< 0.0001
91581213|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-0.9|-1.3|< 0.0001
91769856|NCT01908426|183426860|SUPERIORITY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||||||0.0086
91769857|NCT01782898|183426868|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.82
91769858|NCT01782898|183426869|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.05
91769859|NCT01782898|183426870|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.14
91518248|NCT01986881|182910770|SUPERIORITY||Difference in the Least Squares Means|-1.62|||<|0.001|TWO_SIDED|95.0|-2.12|-1.13|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.12|<0.001
91581214|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-1.1|-1.6|< 0.0001
91581215|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.0|-1.5|< 0.0001
91581216|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.2|-1.8|< 0.0001
91705979|NCT03714776|183306642|SUPERIORITY|||||||0.454||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.454
91705980|NCT03714776|183306642|SUPERIORITY|||||||0.909||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||0.909
91705981|NCT03714776|183306642|SUPERIORITY|||||||0.132||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||0.132
91705982|NCT03714776|183306642|SUPERIORITY|||||||0.659||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||0.659
91705983|NCT03714776|183306642|SUPERIORITY|||||||0.474||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||0.474
91705984|NCT03714776|183306642|SUPERIORITY|||||||0.483||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||0.483
91705985|NCT03714776|183306643|SUPERIORITY|||||||0.064||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.064
91705986|NCT03714776|183306643|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||<0.001
91705987|NCT03714776|183306643|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||<0.001
91705988|NCT03714776|183306643|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||<0.001
91769860|NCT02973100|183426871|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53|||Mixed Models Analysis|||||-0.53|-1.07|<.001
91769861|NCT02973100|183426871|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.14|-0.6|||Mixed Models Analysis|||||-0.60|-1.14|<0.001
91769862|NCT02973100|183426871|SUPERIORITY||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.24|-0.69|||Mixed Models Analysis|||||-0.69|-1.24|<.001
91769863|NCT02973100|183426872|SUPERIORITY||Odds Ratio (OR)|24.489|||<|0.001|TWO_SIDED|95.0|8.368|71.667|||Regression, Logistic|||||71.667|8.368|<.001
91769864|NCT02973100|183426872|SUPERIORITY||Odds Ratio (OR)|27.906|||<|0.001|TWO_SIDED|95.0|9.238|84.3|||Regression, Logistic|||||84.300|9.238|<.001
91769865|NCT02973100|183426872|SUPERIORITY||Odds Ratio (OR)|21.852|||<|0.001|TWO_SIDED|95.0|7.672|62.242|||Regression, Logistic|||||62.242|7.672|<.001
91769866|NCT02973100|183426873|SUPERIORITY||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-2.02|-0.62|||Mixed Models Analysis|||||-0.62|-2.02|<0.001
91769867|NCT02973100|183426873|SUPERIORITY||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.91|-0.54|||Mixed Models Analysis|||||-0.54|-1.91|<0.001
91769868|NCT02973100|183426873|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.001|TWO_SIDED|95.0|-2.12|-0.72|||Mixed Models Analysis|||||-0.72|-2.12|<0.001
91769869|NCT02973100|183426874|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.025|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||||-0.2|-2.3|0.025
91769870|NCT02973100|183426874|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Mixed Models Analysis|||||-1.3|-3.4|<0.001
91769871|NCT02973100|183426874|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.7|-1.5|||Mixed Models Analysis|||||-1.5|-3.7|<0.001
91705989|NCT03714776|183306643|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||<0.001
91705990|NCT03714776|183306643|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||<0.001
91769872|NCT00960622|183426879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.5|<|0.05|TWO_SIDED|95.0|-6.3|11.3|||t-test, 2 sided|||"Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P\<0.05 chosen for statistical significance"||11.3|-6.3|<0.05
91769873|NCT01419236|183426895|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.38|TWO_SIDED|90.0|-0.59|1.91|||Mixed Models Repeated Measure Analysis|||||1.91|-0.59|0.380
91769874|NCT01419236|183426896|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.164|TWO_SIDED|90.0|-0.96|0.08|||Mixed Models Repeated Measures Analysis|||||0.08|-0.96|0.164
91769875|NCT01419236|183426897|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.342|TWO_SIDED|90.0|-0.31|1.15|||Mixed Models Repeated Measure Analysis|||||1.15|-0.31|0.342
91769876|NCT01419236|183426898|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.079|TWO_SIDED|90.0|0.05|1.57|||Mixed Models Repeated Measure Analysis|||||1.57|0.05|0.079
91769877|NCT01419236|183426899|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.535|TWO_SIDED|90.0|-0.5|1.1|||Mixed Models Repeated Measure Analysis|||||1.10|-0.50|0.535
91769878|NCT01419236|183426900|SUPERIORITY_OR_OTHER||LS Mean Difference|1.03||||0.172|TWO_SIDED|90.0|-0.22|2.27|||ANCOVA|||||2.27|-0.22|0.172
91769879|NCT01419236|183426901|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.473|TWO_SIDED|90.0|-0.41|1.04|||Mixed Models Repeated Measure Analysis|||||1.04|-0.41|0.473
91769880|NCT01419236|183426902|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.885|TWO_SIDED|90.0|-1.03|0.87|||Mixed Models Repeated Measure Analysis|||||0.87|-1.03|0.885
91518249|NCT01986881|182910771|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.49|||<|0.001|TWO_SIDED|95.0|1.61|3.83|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||3.83|1.61|<0.001
91705991|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.92|||<|0.001||90.0|-63.84|-35.99|||Mixed Effects Model Analysis|P-value is for Day 43.||||-35.99|-63.84|<0.001
91705992|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.85|||<|0.001||90.0|-48.78|-20.93|||Mixed Effects Model Analysis|P-value is for Day 57.||||-20.93|-48.78|<0.001
91769881|NCT01419236|183426903|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.938|TWO_SIDED|90.0|-0.61|0.55|||Mixed Models Repeated Measure Analysis|||||0.55|-0.61|0.938
91769882|NCT01342913|183426914|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.282|TWO_SIDED|95.0|-0.018|0.063|||ANCOVA|||||0.063|-0.018|0.282
91705993|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.72|||<|0.001||90.0|-62.1|-33.34|||Mixed Effects Model Analysis|P-value is for Day 43.||||-33.34|-62.10|<0.001
91769883|NCT03112681|183426917|SUPERIORITY|||||||0.0001|||||||paired t-test|||||||0.0001
91769884|NCT03112681|183426917|SUPERIORITY|||||||0.0002|||||||paired t-test|||||||0.0002
91705994|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.26|||<|0.001||90.0|-46.69|-17.82|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.82|-46.69|<0.001
91769885|NCT03287791|183426923|SUPERIORITY||Mean Difference (Final Values)|-11.27|||<|0.0001|TWO_SIDED|95.0|-16.8|-5.73|||ANOVA|||Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-5.73|-16.80|<.0001
91769886|NCT03287791|183426923|SUPERIORITY||Median Difference (Final Values)|-9.71||||0.0007|TWO_SIDED|95.0|-15.28|-4.14|||ANOVA|||Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-4.14|-15.28|0.0007
91769887|NCT02891174|183426928|EQUIVALENCE|margin=10 mmHg|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-3.7|5.7|||||The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.|||5.7|-3.7|
91769888|NCT02891174|183426929|SUPERIORITY|||||||0.59||||||Abdominal pain|t-test, 2 sided|||Change in abdominal pain||||0.59
91518250|NCT01986881|182910771|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.6|||<|0.001|TWO_SIDED|95.0|1.64|4.12|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.12|1.64|<0.001
91705995|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.36|||<|0.001||90.0|-60.07|-30.64|||Mixed Effects Model Analysis|P-value is for Day 43.||||-30.64|-60.07|<0.001
91705996|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.04|||<|0.001||90.0|-46.76|-17.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.32|-46.76|<0.001
91705997|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.8|||<|0.001||90.0|-61.12|-32.49|||Mixed Effects Model Analysis|P-value is for Day 43.||||-32.49|-61.12|<0.001
91705998|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.64|||<|0.001||90.0|-58.95|-30.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-30.32|-58.95|<0.001
91705999|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.53||||0.44||90.0|-20.51|7.44|||Mixed Effect Model Analysis|P-value is for Day 127||||7.44|-20.51|0.440
91769889|NCT02891174|183426929|SUPERIORITY|||||||0.91||||||Perineal pain|t-test, 2 sided|||Change in perineal pain||||0.91
91769890|NCT02891174|183426929|SUPERIORITY|||||||0.88||||||Overall pain|t-test, 2 sided|||Change in overall pain||||0.88
91769891|NCT02891174|183426930|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
91769892|NCT02891174|183426931|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||First intervention (24 hours)||||0.02
91769893|NCT02891174|183426931|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Second intervention (24 hours)||||0.06
91769894|NCT02891174|183426931|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Overall satisfaction with pain control during study period||||0.04
91769895|NCT04607668|183426945|OTHER||Mean Difference (Final Values)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6||Two-sided p-value for treatment effect was generated from a nonparametric ANCOVA controlling for stratification factors of Region and Prior chemotherapy with study baseline ANC value as a covariate.|ANCOVA|||||-0.6|-1.7|<0.001
91769896|NCT04607668|183426946|OTHER||aRR|0.04|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.01|0.19|||modified Poisson model|||||0.19|0.01|<0.001
91769897|NCT02250326|183426960|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.94||||Based on stratification factors of ECOG Performance Status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||1.94|0.90|
91769898|NCT02250326|183426961|SUPERIORITY||Disease Control Rate Ratio|0.97|||||TWO_SIDED|95.0|0.778|1.207|||||95% CI was calculated using Clopper-Pearson method.||Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone|1.207|0.778|
91769899|NCT02250326|183426962|SUPERIORITY||Overall Response Rate Ratio|0.84|||||TWO_SIDED|95.0|0.398|1.754|||||95% CI was calculated using Clopper-Pearson method.||Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.|1.754|0.398|
91769900|NCT02250326|183426963|SUPERIORITY||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|1.08|2.57||||Based on stratification factors of ECOG performance status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||2.57|1.08|
91769901|NCT04073186|183426982|SUPERIORITY|The superiority of the First wearing Cycle was concluded if the lower confidence limit of leastsquare mean as greater than 32.|Least-square Mean|59.3|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|54.6|64.0|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.||||64.0|54.6|
91769902|NCT04073186|183426983|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.10 logMAR.|Least-square Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.124|-0.044||Distance (4 Meter)|Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom.||||-0.044|-0.124|
91769903|NCT04073186|183426983|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR.|Least-square Mean|-0.028|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.068|0.012|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Intermediate (64 CM)||0.012|-0.068|
91769904|NCT04073186|183426983|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR|Least-square Means|0.037|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.003|0.077|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Near (40 CM)||0.077|-0.003|
91518251|NCT01986881|182910772|SUPERIORITY||Difference in the Least Squares Means|-2.32||||0.025|TWO_SIDED|95.0|-4.35|-0.3|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.30|-4.35|0.025
91581217|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.3|< 0.0001
91769905|NCT04073186|183426984|SUPERIORITY|The superiority of the Test lens at 4-week followup compared to it at 2-week follow-up will beconcluded if the lower confidence limit of leastsquare mean difference is greater than 0.|Least-square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-8.1|-0.1|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.|LSM difference was calculated as Second Wearing Cycle minus First Wearing Cycle|||-0.1|-8.1|
91769906|NCT05757648|183427000|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.005
91769907|NCT05757648|183427001|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
91769908|NCT05757648|183427002|SUPERIORITY|||||||0.682|||||||Mixed Models Analysis|||||||0.682
91769909|NCT02201524|183427025|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-5.08|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|90.0|-9.15|-1.01||||||PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.01|-9.15|
91769910|NCT02201524|183427025|SUPERIORITY_OR_OTHER||LS mean difference|-5.61|STANDARD_ERROR_OF_MEAN|2.375|||TWO_SIDED|90.0|-9.61|-1.62||||||PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.62|-9.61|
91518252|NCT01986881|182910772|SUPERIORITY||Difference in the Least Squares Means|-2.88||||0.006|TWO_SIDED|95.0|-4.94|-0.82|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.82|-4.94|0.006
91769911|NCT02201524|183427025|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|2.506|||TWO_SIDED|90.0|-14.19|-5.77||||||PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.77|-14.19|
91769912|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-9.32|STANDARD_ERROR_OF_MEAN|8.291|||TWO_SIDED|90.0|-23.19|4.56||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||4.56|-23.19|
91769913|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-11.19|STANDARD_ERROR_OF_MEAN|8.177|||TWO_SIDED|90.0|-24.87|2.5||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.50|-24.87|
91769914|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-19.22|STANDARD_ERROR_OF_MEAN|8.504|||TWO_SIDED|90.0|-33.45|-4.99||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.99|-33.45|
91769915|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED|90.0|-21.71|13.11||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||13.11|-21.71|
91769916|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.273|||TWO_SIDED|90.0|-35.25|-0.82||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.82|-35.25|
91769917|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-27.07|STANDARD_ERROR_OF_MEAN|10.646|||TWO_SIDED|90.0|-44.9|-9.23||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-9.23|-44.90|
91769918|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|11.013|||TWO_SIDED|90.0|-28.53|8.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.39|-28.53|
91769919|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-29.23|STANDARD_ERROR_OF_MEAN|10.793|||TWO_SIDED|90.0|-47.33|-11.13||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.13|-47.33|
91769920|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-49.99|STANDARD_ERROR_OF_MEAN|11.299|||TWO_SIDED|90.0|-68.92|-31.05||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-31.05|-68.92|
91769921|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-24.25|STANDARD_ERROR_OF_MEAN|11.33|||TWO_SIDED|90.0|-43.26|-5.24||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.24|-43.26|
91769922|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-27.47|STANDARD_ERROR_OF_MEAN|11.155|||TWO_SIDED|90.0|-46.18|-8.75||||||PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-8.75|-46.18|
91769923|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-52.63|STANDARD_ERROR_OF_MEAN|11.697|||TWO_SIDED|90.0|-72.24|-33.02||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-33.02|-72.24|
91518253|NCT01986881|182910773|SUPERIORITY||Difference in the Least Squares Means|-0.38||||0.533|TWO_SIDED|95.0|-1.56|0.81|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.81|-1.56|0.533
91518254|NCT01986881|182910773|SUPERIORITY||Difference in the Least Squares Means|-0.6||||0.326|TWO_SIDED|95.0|-1.81|0.6|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.60|-1.81|0.326
91769924|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-17.98|STANDARD_ERROR_OF_MEAN|10.605|||TWO_SIDED|90.0|-35.8|-0.15|||LANCOVA|||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.15|-35.80|
91706000|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.108||90.0|-28.53|0.33|||Mixed Effect Model Analysis|P-value is for Day 127.||||0.33|-28.53|0.108
91769925|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-14.78|STANDARD_ERROR_OF_MEAN|10.513|||TWO_SIDED|90.0|-32.44|2.88||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.88|-32.44|
91769926|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-47.94|STANDARD_ERROR_OF_MEAN|11.125|||TWO_SIDED|90.0|-66.61|-29.27||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-29.27|-66.61|
91769927|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean|-21.75|STANDARD_ERROR_OF_MEAN|11.459|||TWO_SIDED|90.0|-41.0|-2.49||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.49|-41.00|
91769928|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-17.75|STANDARD_ERROR_OF_MEAN|11.416|||TWO_SIDED|90.0|-36.92|1.42||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.42|-36.92|
91769929|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-35.88|STANDARD_ERROR_OF_MEAN|11.893|||TWO_SIDED|90.0|-55.85|-15.9||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-15.90|-55.85|
91769930|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|12.985|||TWO_SIDED|90.0|-32.57|11.07||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||11.07|-32.57|
91769931|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-13.03|STANDARD_ERROR_OF_MEAN|12.902|||TWO_SIDED|90.0|-34.71|8.64||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.64|-34.71|
91769932|NCT02201524|183427026|SUPERIORITY_OR_OTHER||LS mean difference|-34.46|STANDARD_ERROR_OF_MEAN|13.69|||TWO_SIDED|90.0|-57.44|-11.48||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.48|-57.44|
91769933|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.626|||TWO_SIDED|90.0|-4.73|0.72||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.72|-4.73|
91769934|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.603|||TWO_SIDED|90.0|-4.99|0.38||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.38|-4.99|
91769935|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|90.0|-6.45|-0.86||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.86|-6.45|
91769936|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.032|||TWO_SIDED|90.0|-4.49|2.32||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.32|-4.49|
91769937|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.011|||TWO_SIDED|90.0|-7.23|-0.49||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.49|-7.23|
91769938|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.084|||TWO_SIDED|90.0|-8.65|-1.67||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.67|-8.65|
91769939|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-2.34|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|90.0|-6.07|1.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.39|-6.07|
91518255|NCT01986881|182910776|SUPERIORITY||Difference in the Least Squares Means|-12.22||||0.105|TWO_SIDED|95.0|-27.03|2.06|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||2.06|-27.03|0.105
91518256|NCT01986881|182910776|SUPERIORITY||Difference in the Least Squares Means|-13.53||||0.068|TWO_SIDED|95.0|-28.06|1.0|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||1.00|-28.06|0.068
91518257|NCT01986881|182910777|SUPERIORITY||Difference in the Least Squares Means|-0.52||||0.418|TWO_SIDED|95.0|-1.79|0.75|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.75|-1.79|0.418
91518258|NCT01986881|182910777|SUPERIORITY||Difference in the Least Squares Means|-1.07||||0.092|TWO_SIDED|95.0|-2.32|0.18|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.18|-2.32|0.092
91581218|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.4|< 0.0001
91706001|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.41||||0.013||90.0|-37.13|-7.69|||Mixed Effect Model Analysis|P-value is for Day 127.||||-7.69|-37.13|0.013
91518259|NCT01986881|182910778|SUPERIORITY||Odds ratio relative to placebo|1.48||||0.46|TWO_SIDED|95.0|0.52|4.17|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.17|0.52|0.460
91518260|NCT01986881|182910778|SUPERIORITY||Odds ratio relative to placebo|1.62||||0.335|TWO_SIDED|95.0|0.61|4.35|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.35|0.61|0.335
91518261|NCT01986881|182910779|SUPERIORITY||Difference in the Least Squares Means|2.73||||0.255|TWO_SIDED|95.0|-2.0|7.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.45|-2.00|0.255
91518262|NCT01986881|182910779|SUPERIORITY||Difference in the Least Squares Means|2.81||||0.235|TWO_SIDED|95.0|-1.85|7.48|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.48|-1.85|0.235
91518263|NCT01986881|182910780|SUPERIORITY||Difference in the Least Squares Means|1.98||||0.178|TWO_SIDED|95.0|-0.91|4.86|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.86|-0.91|0.178
91518264|NCT01986881|182910780|SUPERIORITY||Difference in the Least Squares Means|1.73||||0.23|TWO_SIDED|95.0|-1.11|4.58|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.58|-1.11|0.230
91518265|NCT01986881|182910781|SUPERIORITY||Difference in the Least Squares Means|-31.37|||<|0.001|TWO_SIDED|95.0|-40.68|-22.07|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-22.07|-40.68|<0.001
91706002|NCT01618916|183306651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.93||||0.042||90.0|-32.42|-3.44|||Mixed Effect Model Analysis|P-value is for Day 127.||||-3.44|-32.42|0.042
91769940|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-6.12|STANDARD_ERROR_OF_MEAN|2.177|||TWO_SIDED|90.0|-9.78|-2.47||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.47|-9.78|
91769941|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-9.39|STANDARD_ERROR_OF_MEAN|2.286|||TWO_SIDED|90.0|-13.22|-5.56||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.56|-13.22|
91769942|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-3.25|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|90.0|-6.71|0.21||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.21|-6.71|
91769943|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|2.035|||TWO_SIDED|90.0|-6.4|0.45||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.45|-6.40|
91769944|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-8.59|STANDARD_ERROR_OF_MEAN|2.167|||TWO_SIDED|90.0|-12.24|-4.95||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.95|-12.24|
91769945|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-3.98|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|90.0|-7.89|-0.08||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.08|-7.89|
91769946|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.304|||TWO_SIDED|90.0|-7.68|0.07||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.07|-7.68|
91706003|NCT03292471|183306652|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.284|||||TWO_SIDED|95.0|-2.07|2.92|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.92|-2.07|
91706004|NCT03292471|183306652|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Follow-up) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.02|||||TWO_SIDED|95.0|-2.38|2.46|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.46|-2.38|
91706005|NCT03292471|183306653|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Entry, Exit) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.997|||||TWO_SIDED|95.0|-0.0719|2.25|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.25|-0.0719|
91706006|NCT03292471|183306653|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time-point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.443|||||TWO_SIDED|95.0|-0.596|1.58|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||1.58|-0.596|
91706007|NCT00911586|183306663|OTHER|Part 1 of piecewise linear regression model.|Slope|-4.077|STANDARD_ERROR_OF_MEAN|16.02||0.806|TWO_SIDED||||||Regression, Linear|Part 1 of piecewise linear regression model.|Part 1 of piecewise linear regression model.|||||0.8060
91706008|NCT00911586|183306664|OTHER|Part 2 of piecewise linear regression model.|Slope|4.114|STANDARD_ERROR_OF_MEAN|18.456||0.8286|TWO_SIDED||||||Regression, Linear|Part 2 of piecewise linear regression model.|Part 2 of piecewise linear regression model.|||||0.8286
91706009|NCT00938587|183306666|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.291||0.0141|TWO_SIDED|90.0|-1.21|-0.24|||MMRM|||Day 14: Treatment difference and its corresponding 90 percent (%) confidence interval (CI) was based on least squares (LS) mean difference using mixed-model repeated measure (MMRM) where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and compound symmetry (CS) as covariance structure.||-0.24|-1.21|0.0141
91706010|NCT00938587|183306666|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.283|<|0.0001|TWO_SIDED|90.0|-1.73|-0.79|||MMRM|||Day 14: Treatment difference and its corresponding 90 % CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.79|-1.73|<0.0001
91706011|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.865||0.437|TWO_SIDED|90.0|-4.54|1.63|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.63|-4.54|0.4370
91581219|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-0.8|-1.3|< 0.0001
91581220|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-1|-1.6|< 0.0001
91581221|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.0|-1.5|< 0.0001
91706012|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.858||0.1802|TWO_SIDED|90.0|-5.58|0.57|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.57|-5.58|0.1802
91706013|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.832||0.6012|TWO_SIDED|90.0|-3.99|2.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.07|-3.99|0.6012
91706014|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.834||0.2753|TWO_SIDED|90.0|-5.04|1.03|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-5.04|0.2753
91581222|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.1|-1.7|< 0.0001
91581223|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.0|-1.5|< 0.0001
91581224|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.2|-1.8|< 0.0001
91706015|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|1.844||0.7892|TWO_SIDED|90.0|-2.56|3.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.55|-2.56|0.7892
91706016|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|1.937||0.3765|TWO_SIDED|90.0|-4.92|1.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.49|-4.92|0.3765
91706017|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|1.873||0.0571|TWO_SIDED|90.0|-6.69|-0.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.49|-6.69|0.0571
91706018|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|1.896||0.6553|TWO_SIDED|90.0|-3.99|2.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.29|-3.99|0.6553
91706019|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.72|STANDARD_ERROR_OF_MEAN|1.847||0.1427|TWO_SIDED|90.0|-5.78|0.33|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.33|-5.78|0.1427
91706020|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|1.873||0.643|TWO_SIDED|90.0|-2.23|3.97|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.97|-2.23|0.6430
91581225|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.1|< 0.0001
91581226|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.2|< 0.0001
91706021|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.918||0.5868|TWO_SIDED|90.0|-2.13|4.22|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.22|-2.13|0.5868
91581227|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.7|-1.2|< 0.0001
91581228|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.8|-1.3|< 0.0001
91706022|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|1.873||0.586|TWO_SIDED|90.0|-4.12|2.08|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-4.12|0.5860
91706023|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.879||0.3288|TWO_SIDED|90.0|-1.27|4.95|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.95|-1.27|0.3288
91706024|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.846||0.9027|TWO_SIDED|90.0|-3.28|2.83|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.83|-3.28|0.9027
91581229|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-0.8|-1.3|< 0.0001
91581230|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-1.0|-1.5|< 0.0001
91581231|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-0.9|-1.4|< 0.0001
91581232|NCT04797650|183052264|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-1.1|-1.6|< 0.0001
91706025|NCT00938587|183306667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.871||0.671|TWO_SIDED|90.0|-2.3|3.89|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.89|-2.30|0.6710
91769947|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.412|||TWO_SIDED|90.0|-11.0|-2.89||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.89|-11.00|
91518266|NCT01986881|182910781|SUPERIORITY||Difference in the Least Squares Means|-30.47|||<|0.001|TWO_SIDED|95.0|-40.23|-20.72|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-20.72|-40.23|<0.001
91518267|NCT01986881|182910782|SUPERIORITY||Difference in the Least Squares Means|-1.94|||<|0.001|TWO_SIDED|95.0|-2.65|-1.24|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-1.24|-2.65|<0.001
91581233|NCT04797650|183052265|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.1206|TWO_SIDED|95.0|-0.1|1.0||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.0|-0.1|0.1206
91581234|NCT04797650|183052265|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34||0.5367|TWO_SIDED|95.0|-0.5|0.9||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.5|0.5367
91581235|NCT04797650|183052265|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.29||0.0064|TWO_SIDED|95.0|0.2|1.3||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.3|0.2|0.0064
91581236|NCT04797650|183052265|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.33||0.0011|TWO_SIDED|95.0|0.4|1.7||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.7|0.4|0.0011
91581237|NCT04797650|183052266|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.19|0.3||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.3|0.19|< 0.0001
91581238|NCT04797650|183052266|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.18|0.33||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.18|< 0.0001
91581239|NCT02937454|183052283|OTHER||Annualised event rate ratio (RR)|0.79||||0.059|TWO_SIDED|95.0|0.62|1.01|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.01|0.62|0.059
91769948|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.607|||TWO_SIDED|90.0|-5.65|3.11||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||3.11|-5.65|
91769949|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|2.586|||TWO_SIDED|90.0|-7.18|1.51||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.51|-7.18|
91518268|NCT01986881|182910782|SUPERIORITY||Difference in the Least Squares Means|-1.57|||<|0.001|TWO_SIDED|95.0|-2.3|-0.84|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-0.84|-2.30|<0.001
91518269|NCT01986881|182910783|SUPERIORITY||Adjusted odds ratio relative to placebo|4.1|||<|0.001|TWO_SIDED|95.0|2.0|8.42|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||8.42|2.00|<0.001
91518270|NCT01986881|182910783|SUPERIORITY||Adjusted odds ratio relative to placebo|5.97|||<|0.001|TWO_SIDED|95.0|2.86|12.49|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||12.49|2.86|<0.001
91518271|NCT01986881|182910784|SUPERIORITY||Difference in the Least Squares Means|-0.85||||0.597|TWO_SIDED|95.0|-4.0|2.3|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||2.30|-4.00|0.597
91581240|NCT02937454|183052283|OTHER||Annualised event rate ratio (RR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Covid-19 Sensitivity Analysis||0.96|0.59|0.024
91581241|NCT02937454|183052284|OTHER||Annualised event rate ratio (RR)|0.8||||0.05|TWO_SIDED|95.0|0.64|1.0|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.0|0.64|0.050
91581242|NCT02937454|183052284|OTHER||Annualised event rate ratio (RR)|0.77||||0.024|TWO_SIDED|95.0|0.62|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.97|0.62|0.024
91581243|NCT02937454|183052285|OTHER||Annualised event rate ratio (RR)|0.74||||0.013|TWO_SIDED|95.0|0.58|0.94|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.94|0.58|0.013
91581244|NCT02937454|183052285|OTHER||Annualised event rate ratio (RR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.90|0.55|0.005
91581245|NCT02937454|183052286|OTHER||Hazard Ratio (HR)|0.96||||0.809|TWO_SIDED|95.0|0.7|1.32|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||1.32|0.70|0.809
91581246|NCT02937454|183052286|OTHER||Hazard Ratio (HR)|0.94||||0.687|TWO_SIDED|95.0|0.68|1.29|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||1.29|0.68|0.687
91581247|NCT02937454|183052287|OTHER||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.66|0.98|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||0.98|0.66|0.030
91581248|NCT02937454|183052287|OTHER||Hazard Ratio (HR)|0.79||||0.023|TWO_SIDED|95.0|0.65|0.97|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||0.97|0.65|0.023
91581249|NCT02937454|183052288|OTHER||Annualised event rate ratio (RR)|0.67||||0.035|TWO_SIDED|95.0|0.47|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.97|0.47|0.035
91581250|NCT02937454|183052288|OTHER||Annualised event rate ratio (RR)|0.61||||0.009|TWO_SIDED|95.0|0.42|0.88|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country||Covid-19 Sensitivity Analysis||0.88|0.42|0.009
91581251|NCT02937454|183052289|OTHER||Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.59|0.92|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.92|0.59|0.006
91518272|NCT01986881|182910784|SUPERIORITY||Difference in the Least Squares Means|-1.57||||0.351|TWO_SIDED|95.0|-4.87|1.73|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.73|-4.87|0.351
91581252|NCT02937454|183052290|OTHER||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.63|0.94|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.94|0.63|0.009
91581253|NCT02937454|183052291|OTHER||Hazard Ratio (HR)|0.99||||0.944|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||1.31|0.75|0.944
91581254|NCT02937454|183052292|OTHER||Odds Ratio (OR)|1.14||||0.196|TWO_SIDED|95.0|0.93|1.39|||Generalised Estimating Equations (GEE)|The following variables are included in the GEE model: treatment, visit, baseline NYHA class, sex, age, HF aetiology, HF duration, and country||Full Analysis Set (FAS)||1.39|0.93|0.196
91581255|NCT02937454|183052293|OTHER|||||||0.208|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.208
91581256|NCT02937454|183052293|OTHER|||||||0.408|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.408
91581257|NCT02937454|183052293|OTHER|||||||0.999|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.999
91581258|NCT02937454|183052294|OTHER|||||||0.227|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 2||||0.227
91581259|NCT02937454|183052294|OTHER|||||||0.018|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 4||||0.018
91581260|NCT02937454|183052294|OTHER|||||||0.005|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.005
91581261|NCT02937454|183052294|OTHER|||||||0.006|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 12||||0.006
91581262|NCT02937454|183052294|OTHER|||||||0.028|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.028
91581263|NCT02937454|183052294|OTHER|||||||0.136|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 36||||0.136
91581264|NCT02937454|183052294|OTHER|||||||0.329|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.329
91581265|NCT04601870|183052302|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $50 arm vs. $0 arm|||3.973|.566|0.4137
91581266|NCT04601870|183052302|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $100 arm vs. $0 arm|||3.973|.566|0.4137
91581267|NCT04601870|183052302|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3383|TWO_SIDED|95.0|0.653|3.446|||Chi-squared|Chi squared equals 0.917 with 1 degrees of freedom|Odds ratio for completing counseling in $50 or $100 arm vs. $0 arm|$0 vs. $50 or $100||3.446|.653|.3383
91518273|NCT01986881|182910785|SUPERIORITY||Difference in the Least Squares Means|-0.68||||0.49|TWO_SIDED|95.0|-2.6|1.25|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.25|-2.60|0.490
91518274|NCT01986881|182910785|SUPERIORITY||Difference in the Least Squares Means|-0.05||||0.958|TWO_SIDED|95.0|-2.07|1.96|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.96|-2.07|0.958
91518275|NCT01258608|182910792|OTHER||Hazard Ratio (HR)|1.192||||0.7382|ONE_SIDED|90.0||1.737||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.737||0.7382
91518276|NCT01258608|182910793|OTHER||Hazard Ratio (HR)|0.922||||0.3156|ONE_SIDED|90.0||1.288||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.288||0.3156
91518277|NCT01258608|182910794|OTHER||Hazard Ratio (HR)|1.007||||0.6121|ONE_SIDED|90.0||1.346||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.346||0.6121
91518278|NCT01258608|182910795|OTHER||Hazard Ratio (HR)|1.066||||0.6925|ONE_SIDED|90.0||1.43||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.430||0.6925
91518279|NCT01258608|182910796|OTHER||Hazard Ratio (HR)|0.909||||0.3088|ONE_SIDED|90.0||1.191||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.191||0.3088
91518280|NCT01258608|182910797|OTHER||Response rate difference|5.4||||0.5458|TWO_SIDED|95.0|-16.8|26.6||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.6|-16.8|0.5458
91518281|NCT01258608|182910798|OTHER||Response rate difference|6.7||||0.3479|TWO_SIDED|95.0|-13.4|26.2||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.2|-13.4|0.3479
91518282|NCT01258608|182910799|OTHER||Disease control rate difference|-20.7||||0.0198|TWO_SIDED|95.0|-40.8|1.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||1.8|-40.8|0.0198
91518283|NCT01258608|182910800|OTHER||Disease control rate difference|-5.8||||0.6558|TWO_SIDED|95.0|-25.4|13.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||13.8|-25.4|0.6558
91518284|NCT04250727|182910820|SUPERIORITY|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||||||0.601
91518285|NCT00447057|182910827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0047|TWO_SIDED|95.0|0.438|0.897|||Log Rank|Log-rank test with 1-sided alpha of 0.20||||0.897|0.438|0.0047
91518286|NCT00447057|182910828|SUPERIORITY_OR_OTHER|||||||0.3909|||||||Fisher Exact|||||||0.3909
91518287|NCT00447057|182910829|SUPERIORITY_OR_OTHER|||||||0.1808|||||||Fisher Exact|||||||0.1808
91518288|NCT00447057|182910830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0034|TWO_SIDED|95.0|0.457|0.887||1-sided significance level of 0.20|Log Rank|||||0.887|0.457|0.0034
91518289|NCT00447057|182910831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.019|TWO_SIDED|95.0|0.465|0.981||1-sided significance level of 0.20|Log Rank|||||0.981|0.465|0.0190
91518290|NCT00184548|182910834|SUPERIORITY_OR_OTHER|||||||0.934||||||Two-sided significance level 5%|Regression, Logistic|||Test for Odds ratio=1, corresponding to a null hypothesis of no difference in mortality for patients who died between groups for Blunt Trauma. Odds-ratio is adjusted for baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury (P/F \> 200). Missing covariates are imputed by the mean value.||||0.934
91518291|NCT00184548|182910834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.589||95.0|0.64|2.17||Two-sided significance level 5%|Cox Proportional Hazards Model|||Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma -Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury.||2.17|0.64|0.589
91518292|NCT00184548|182910836|SUPERIORITY_OR_OTHER||LS means|0.9||||0.308||95.0|-0.83|2.63|||ANCOVA|||Baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury.||2.63|-0.83|0.308
91518293|NCT00184548|182910838|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|1.0||||0.038||95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|0.038
91518294|NCT00184548|182910839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.175||||0.384||95.0|0.817|1.69|||Regression, Logistic|||||1.690|0.817|0.384
91518295|NCT00184548|182910840|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|2.0||||0.03||95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|0|0.030
91518296|NCT04493216|182910841|OTHER||Differences in percentage of participant|-9.2|||||TWO_SIDED|95.0|-24.0|5.7|||||Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF|||5.7|-24.0|
91581268|NCT04601870|183052303|SUPERIORITY||Odds Ratio (OR)|2.333||||0.265|TWO_SIDED|95.0|0.51|10.6751|||Chi-squared|Chi squared equals 1.243 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 arm vs. $0 arm|||10.6751|.5100|.2650
91581269|NCT04601870|183052303|SUPERIORITY||Odds Ratio (OR)|0.8333||||0.8472|TWO_SIDED|95.0|0.1301|5.3369|||Chi-squared|Chi squared equals 0.037 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $0 arm|||5.3369|.1301|.8472
91581270|NCT04601870|183052303|SUPERIORITY||Odds Ratio (OR)|1.541||||0.5478|TWO_SIDED|95.0|0.3731|6.364|||Chi-squared|Chi squared equals 0.361 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 or $100 arms vs. $0 arm|$0 vs. $50 or $100||6.3640|.3731|.5478
91518297|NCT04493216|182910841|OTHER||Differences in percentage of participant|-1.0|||||TWO_SIDED|95.0|-13.5|11.6|||||Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||11.6|-13.5|
91518298|NCT04493216|182910841|OTHER||Differences in percentage of participant|-15.5|||||TWO_SIDED|95.0|-31.2|0.3|||||Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||0.3|-31.2|
91518299|NCT04605978|182910863|SUPERIORITY||Mean Difference (Net)|2.44|||||TWO_SIDED|95.0|-0.61|5.49|||||Missing data and data post intercurrent event were imputed for the statistical analysis as specified in the statistical analysis plan.|||5.49|-0.61|
91581271|NCT04601870|183052303|SUPERIORITY||Odds Ratio (OR)|0.3571||||0.2276|TWO_SIDED|95.0|0.06355|2.007|||Chi-squared|Chi squared equals 1.456 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $50 arm|||2.0070|.06355|.2276
91581272|NCT01534689|183052310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91581273|NCT01534689|183052311|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||results at 12 weeks compared to baseline||||<0.0001
91581274|NCT01160289|183052320|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.5
91581275|NCT01160289|183052320|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.498
91581276|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.178|STANDARD_ERROR_OF_MEAN|3.312||0.722||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.722
91581277|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.552|STANDARD_ERROR_OF_MEAN|3.253||0.634||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.634
91581278|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-4.674|STANDARD_ERROR_OF_MEAN|3.218||0.147||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.147
91518300|NCT02216123|182910873|OTHER||Mean Difference (Final Values)|1.23|||||TWO_SIDED|95.0|-4.161|4.982|||||Confidence interval for the treatment difference was based on the Newcombe method. Percent treatment difference (TQ+CQ-PQ+CQ) has been presented.|||4.982|-4.161|
91518301|NCT02216123|182910875|OTHER||Hazard Ratio (HR)|0.984||||||95.0|0.577|1.678|||||Hazards ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio \<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.678|0.577|
91518302|NCT02216123|182910876|OTHER||Hazard Ratio (HR)|0.815|||||TWO_SIDED|95.0|0.442|1.503|||||Hazard ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio\<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.503|0.442|
91581279|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.404|STANDARD_ERROR_OF_MEAN|3.157||0.02||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.020
91581280|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.33|STANDARD_ERROR_OF_MEAN|4.658||0.775||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.775
91581281|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.844|STANDARD_ERROR_OF_MEAN|4.573||0.687||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.687
91581282|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.092|STANDARD_ERROR_OF_MEAN|4.535||0.119||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.119
91581283|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-6.578|STANDARD_ERROR_OF_MEAN|4.45||0.14||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.140
91581284|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|6.703|STANDARD_ERROR_OF_MEAN|5.302||0.207||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.207
91518303|NCT03318523|182910907|SUPERIORITY|Adjusted mean, difference with placebo, 95% confidence interval (CI), and p-value were based on a mixed model for repeated measures (MMRM) model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.3||||0.8976|TWO_SIDED|95.0|-4.888|4.287|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.287|-4.888|0.8976
91518304|NCT03318523|182910907|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.5||||0.796|TWO_SIDED|95.0|-3.31|4.312|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.312|-3.310|0.7960
91518305|NCT03318523|182910907|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.08||||0.9695|TWO_SIDED|95.0|-3.805|3.956|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||3.956|-3.805|0.9695
91518306|NCT03318523|182910908|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.28||||0.9093|TWO_SIDED|95.0|-5.035|4.483|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||4.483|-5.035|0.9093
91518307|NCT03318523|182910908|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|1.55||||0.4327|TWO_SIDED|95.0|-2.336|5.44|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||5.440|-2.336|0.4327
91518308|NCT03318523|182910908|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.17||||0.933|TWO_SIDED|95.0|-4.051|3.719|||Mixed Model with repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||3.719|-4.051|0.9330
91518309|NCT03318523|182910910|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.41||||0.8828|TWO_SIDED|95.0|-5.013|5.825|||Mixed Model for Repeated Measures|||||5.825|-5.013|0.8828
91518310|NCT03318523|182910910|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.84||||0.7019|TWO_SIDED|95.0|-3.458|5.128|||Mixed Model for Repeated Measure|||||5.128|-3.458|0.7019
91706026|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|1.123||0.837|TWO_SIDED|90.0|-1.63|2.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.09|-1.63|0.8370
91706027|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.96|STANDARD_ERROR_OF_MEAN|1.12||0.0819|TWO_SIDED|90.0|-3.81|-0.11|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.11|-3.81|0.0819
91524186|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|37.72|||<|0.001|TWO_SIDED|95.0|24.36|51.07||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.07|24.36|<0.001
91706028|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|1.106||0.8892|TWO_SIDED|90.0|-1.98|1.67|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.67|-1.98|0.8892
91706029|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.106||0.0353|TWO_SIDED|90.0|-4.17|-0.52|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.52|-4.17|0.0353
91518311|NCT03318523|182910910|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.99||||0.6519|TWO_SIDED|95.0|-3.323|5.301|||Mixed Model for Repeated Measures|||||5.301|-3.323|0.6519
91518312|NCT03318523|182910912|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.4327|TWO_SIDED|95.0|-1.851|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||0.794|-1.851|0.4327
91518313|NCT03318523|182910912|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.13||||0.8155|TWO_SIDED|95.0|-0.965|1.225|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.225|-0.965|0.8155
91518314|NCT03318523|182910912|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.22||||0.7015|TWO_SIDED|95.0|-0.899|1.334|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.334|-0.899|0.7015
91518315|NCT03318523|182910913|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-1.03||||0.1038|TWO_SIDED|95.0|-2.276|0.213|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||0.213|-2.276|0.1038
91518316|NCT03318523|182910913|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.09||||0.8689|TWO_SIDED|95.0|-0.933|1.103|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.103|-0.933|0.8689
91518317|NCT03318523|182910913|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.01||||0.982|TWO_SIDED|95.0|-1.026|1.003|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.003|-1.026|0.9820
91518318|NCT03318523|182910913|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.26||||0.693|TWO_SIDED|95.0|-1.563|1.04|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.040|-1.563|0.6930
91518319|NCT03318523|182910913|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.03||||0.9606|TWO_SIDED|95.0|-1.053|1.001|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.001|-1.053|0.9606
91769950|NCT02201524|183427027|SUPERIORITY_OR_OTHER||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|2.758|||TWO_SIDED|90.0|-11.15|-1.89||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.89|-11.15|
91524187|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|10.97||||0.144|TWO_SIDED|95.0|-3.67|25.61||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.61|-3.67|0.144
91518320|NCT03318523|182910913|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.24||||0.6512|TWO_SIDED|95.0|-1.269|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||0.794|-1.269|0.6512
91518321|NCT03318523|182910914|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.44||||0.5497|TWO_SIDED|95.0|-1.889|1.007|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.007|-1.889|0.5497
91518322|NCT03318523|182910914|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.0||||0.998|TWO_SIDED|95.0|-1.2|1.197|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.197|-1.200|0.9980
91518323|NCT03318523|182910914|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8069|TWO_SIDED|95.0|-1.374|1.07|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.070|-1.374|0.8069
91518324|NCT03318523|182910915|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.21||||0.7968|TWO_SIDED|95.0|-1.786|1.372|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.372|-1.786|0.7968
91518325|NCT03318523|182910915|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.53||||0.4211|TWO_SIDED|95.0|-0.766|1.827|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.827|-0.766|0.4211
91706030|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.108||0.7283|TWO_SIDED|90.0|-2.22|1.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.45|-2.22|0.7283
91769951|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|90.0|-21.5|19.6||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||19.6|-21.5|
91518326|NCT03318523|182910915|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8166|TWO_SIDED|95.0|-1.448|1.143|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.143|-1.448|0.8166
91581285|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|9.159|STANDARD_ERROR_OF_MEAN|5.206||0.079||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.079
91706031|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.174||0.9083|TWO_SIDED|90.0|-1.81|2.08|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-1.81|0.9083
91769952|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-5.9|40.3||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||40.3|-5.9|
91769953|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|90.0|-9.3|38.0|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||38.0|-9.3|
91769954|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.3|||||TWO_SIDED|90.0|-38.0|9.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||9.3|-38.0|
91518327|NCT03318523|182910915|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.5535|TWO_SIDED|95.0|-2.31|1.24|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.240|-2.310|0.5535
91518328|NCT03318523|182910915|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.52||||0.4654|TWO_SIDED|95.0|-0.881|1.922|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.922|-0.881|0.4654
91518329|NCT03318523|182910915|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.36||||0.6184|TWO_SIDED|95.0|-1.051|1.763|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.763|-1.051|0.6184
91518330|NCT03318523|182910916|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.59||||0.7274|TWO_SIDED|95.0|-2.742|3.925|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.925|-2.742|0.7274
91518331|NCT03318523|182910916|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.66||||0.6385|TWO_SIDED|95.0|-2.094|3.411|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.411|-2.094|0.6385
91518332|NCT03318523|182910916|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.1||||0.9467|TWO_SIDED|95.0|-2.718|2.91|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||2.910|-2.718|0.9467
91518333|NCT03318523|182910917|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.85||||0.6112|TWO_SIDED|95.0|-2.423|4.114|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||4.114|-2.423|0.6112
91524188|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
91581286|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-5.349|STANDARD_ERROR_OF_MEAN|5.165||0.301||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.301
91581287|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-2.893|STANDARD_ERROR_OF_MEAN|5.067||0.568||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.568
91581288|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.079|STANDARD_ERROR_OF_MEAN|5.566||0.464||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.464
91581289|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.054|STANDARD_ERROR_OF_MEAN|5.463||0.356||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.356
91581290|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-11.266|STANDARD_ERROR_OF_MEAN|5.418||0.038||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.038
91581291|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-10.292|STANDARD_ERROR_OF_MEAN|5.312||0.054||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.054
91518334|NCT03318523|182910917|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.86||||0.527|TWO_SIDED|95.0|-1.806|3.52|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||3.520|-1.806|0.5270
91518335|NCT03318523|182910917|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.06||||0.9673|TWO_SIDED|95.0|-2.608|2.719|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||2.719|-2.608|0.9673
91518336|NCT03318523|182910917|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.65||||0.7455|TWO_SIDED|95.0|-3.274|4.569|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||4.569|-3.274|0.7455
91518337|NCT03318523|182910917|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.1||||0.9506|TWO_SIDED|95.0|-3.192|2.997|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||2.997|-3.192|0.9506
91518338|NCT03318523|182910917|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.69||||0.6643|TWO_SIDED|95.0|-2.422|3.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||3.794|-2.422|0.6643
91518339|NCT03318523|182910918|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.005||||0.8274|TWO_SIDED|95.0|-0.0548|0.0438|||Mixed Model for Repeated Measures|||||0.0438|-0.0548|0.8274
91518340|NCT03318523|182910918|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.6671|TWO_SIDED|95.0|-0.0504|0.0323|||Mixed Model for Repeated Measures|||||0.0323|-0.0504|0.6671
91518341|NCT03318523|182910918|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.033||||0.1313|TWO_SIDED|95.0|-0.0751|0.0098|||Mixed Model for Repeated Measures|||||0.0098|-0.0751|0.1313
91518342|NCT03318523|182910919|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.7079|TWO_SIDED|95.0|-0.0562|0.0382|||Mixed Model for Repeated Measures|||||0.0382|-0.0562|0.7079
91581292|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.202|STANDARD_ERROR_OF_MEAN|5.603||0.454||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.454
91581293|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.796|STANDARD_ERROR_OF_MEAN|5.499||0.293||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.293
91581294|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-8.808|STANDARD_ERROR_OF_MEAN|5.457||0.107||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.107
91769955|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|90.0|-25.4|29.1||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||29.1|-25.4|
91518343|NCT03318523|182910919|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.0||||0.9835|TWO_SIDED|95.0|-0.04|0.0392|||Mixed Model for Repeated Measures|||||0.0392|-0.0400|0.9835
91518344|NCT03318523|182910919|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.027||||0.1869|TWO_SIDED|95.0|-0.0682|0.0134|||Mixed Model for Repeated Measures|||||0.0134|-0.0682|0.1869
91518345|NCT03318523|182910920|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.008||||0.7585|TWO_SIDED|95.0|-0.0625|0.0456|||Mixed Model for Repeated Measures|||||0.0456|-0.0625|0.7585
91518346|NCT03318523|182910920|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.006||||0.7808|TWO_SIDED|95.0|-0.0391|0.052|||Mixed Model for Repeated Measures|||||0.0520|-0.0391|0.7808
91518347|NCT03318523|182910920|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.022||||0.3532|TWO_SIDED|95.0|-0.0691|0.0248|||Mixed Model for Repeated Measures|||||0.0248|-0.0691|0.3532
91518348|NCT02163733|182910922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|106.05|||||TWO_SIDED|90.0|94.82|118.6|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||118.60|94.82|
91769956|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|20.2|||||TWO_SIDED|90.0|-10.2|48.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||48.3|-10.2|
91518349|NCT02163733|182910923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%|Geometric mean ratio|92.75|||||TWO_SIDED|90.0|81.4|105.68|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||105.68|81.40|
91518350|NCT02163733|182910931|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|81.15|||||TWO_SIDED|90.0|57.86|113.83|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.|AZ5104||113.83|57.86|
91706032|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.132||0.1641|TWO_SIDED|90.0|-3.45|0.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.29|-3.45|0.1641
91706033|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.155||0.817|TWO_SIDED|90.0|-1.64|2.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.18|-1.64|0.8170
91706034|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.116||0.1958|TWO_SIDED|90.0|-3.29|0.4|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.40|-3.29|0.1958
91706035|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.13||0.907|TWO_SIDED|90.0|-1.74|2.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.00|-1.74|0.9070
91706036|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0023|TWO_SIDED|90.0|1.67|5.5|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.50|1.67|0.0023
91769957|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|1.9|||||TWO_SIDED|90.0|-26.7|31.0||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||31.0|-26.7|
91769958|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|23.6|||||TWO_SIDED|90.0|-6.9|49.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||49.8|-6.9|
91518351|NCT02163733|182910931|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|88.21|||||TWO_SIDED|90.0|65.21|119.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.|AZ7550||119.32|65.21|
91518352|NCT02163733|182910932|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|76.68|||||TWO_SIDED|90.0|55.31|106.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.|AZ5104||106.32|55.31|
91518353|NCT02163733|182910932|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|82.92|||||TWO_SIDED|90.0|60.99|112.74|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.|AZ7550||112.74|60.99|
91518354|NCT01654549|182910981|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.94
91518355|NCT01654549|182910981|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
91518356|NCT01654549|182910981|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
91518357|NCT01654549|182910981|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
91518358|NCT01654549|182910981|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
91518359|NCT05554237|182910990|OTHER||Ratio of adjusted geometric means|83.46|||||TWO_SIDED|90.0|74.67|93.29|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only)|||93.29|74.67|
91518360|NCT05554237|182910992|OTHER||Ratio of adjusted geometric means|89.7|||||TWO_SIDED|90.0|87.24|92.23|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.23|87.24|
91518361|NCT05554237|182910995|OTHER||Ratio of adjusted geometric means|89.91|||||TWO_SIDED|90.0|87.47|92.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.41|87.47|
91518362|NCT05554237|182911015|OTHER||Ratio of adjusted geometric mean|104.47|||||TWO_SIDED|90.0|84.94|128.5|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||128.50|84.94|
91518363|NCT05554237|182911015|OTHER||Ratio of adjusted geometric mean|129.54|||||TWO_SIDED|90.0|119.37|140.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||140.58|119.37|
91769959|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|67.8|||||TWO_SIDED|90.0|36.4|85.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||85.3|36.4|
91518364|NCT05554237|182911015|OTHER||Ratio of adjusted geometric mean|101.46|||||TWO_SIDED|90.0|88.68|116.08|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||116.08|88.68|
91518365|NCT05554237|182911015|OTHER||Ratio of adjusted geometric means|86.99|||||TWO_SIDED|90.0|74.48|101.59|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||101.59|74.48|
91518366|NCT05554237|182911017|OTHER||Ratio of adjusted geometric mean|102.21|||||TWO_SIDED|90.0|88.67|117.8|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||117.80|88.67|
91518367|NCT05554237|182911017|OTHER||Ratio of adjusted geometric mean|133.79|||||TWO_SIDED|90.0|119.84|149.36|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||149.36|119.84|
91518368|NCT05554237|182911017|OTHER||Ratio of adjusted geometric mean|99.93|||||TWO_SIDED|90.0|90.7|110.1|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||110.10|90.70|
91518369|NCT05554237|182911017|OTHER||Ratio of adjusted geometric mean|89.17|||||TWO_SIDED|90.0|75.27|105.63|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||105.63|75.27|
91518370|NCT05554237|182911023|OTHER||Ratio of adjusted geometric mean|93.69|||||TWO_SIDED|90.0|78.37|112.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||112.02|78.37|
91518371|NCT05554237|182911023|OTHER||Ratio of adjusted geometric mean|113.07|||||TWO_SIDED|90.0|88.31|144.76|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI-CTB Day 6 versus Day 7||144.76|88.31|
91518372|NCT05554237|182911023|OTHER||Ratio of adjusted geometric mean|107.06||||||90.0|92.77|123.54|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||123.54|92.77|
91518373|NCT05554237|182911023|OTHER||Ratio of adjusted geometric mean|80.68|||||TWO_SIDED|90.0|68.32|95.27|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||95.27|68.32|
91518374|NCT05554237|182911023|OTHER||Ratio of adjusted geometric mean|89.92|||||TWO_SIDED|90.0|69.7|116.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||116.02|69.70|
91518375|NCT05554237|182911023|OTHER||Ratio of adjusted geometric mean|97.65|||||TWO_SIDED|90.0|84.08|113.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||113.41|84.08|
91518376|NCT05554237|182911024|OTHER||Ratio of adjusted geometric mean|102.33|||||TWO_SIDED|90.0|90.37|115.87|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||115.87|90.37|
91518377|NCT05554237|182911024|OTHER||Ratio of adjusted geometric mean|117.83|||||TWO_SIDED|90.0|100.61|138.0|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||138.00|100.61|
91518378|NCT05554237|182911024|OTHER||Ratio of adjusted geometric mean|115.88|||||TWO_SIDED|90.0|104.12|128.98|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||128.98|104.12|
91518379|NCT05554237|182911024|OTHER||Ratio of adjusted geometric mean|85.27|||||TWO_SIDED|90.0|70.37|103.32|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||103.32|70.37|
91518380|NCT05554237|182911024|OTHER||Ratio of adjusted geometric mean|97.69|||||TWO_SIDED|90.0|78.83|121.06|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||121.06|78.83|
91518381|NCT05554237|182911024|OTHER||Ratio of adjusted geometric mean|102.85|||||TWO_SIDED|90.0|94.8|111.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||111.58|94.80|
91518382|NCT05554237|182911039|OTHER||Ratio of adjusted geometric mean|105.47|||||TWO_SIDED|90.0|86.64|128.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||128.39|86.64|
91518383|NCT05554237|182911039|OTHER||Ratio of adjusted geometric mean|134.24||||||90.0|51.81|347.81|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||347.81|51.81|
91518384|NCT05554237|182911039|OTHER||Ratio of adjusted geometric mean|91.17||||||90.0|79.54|104.51|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||104.51|79.54|
91518385|NCT05554237|182911039|OTHER||Ratio of adjusted geometric mean|115.26|||||TWO_SIDED|90.0|71.46|185.9|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||185.90|71.46|
91706037|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.132||0.1531|TWO_SIDED|90.0|-0.25|3.49|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.49|-0.25|0.1531
91518386|NCT05554237|182911041|OTHER||Ratio of adjusted geometric mean|114.83|||||TWO_SIDED|90.0|101.1|130.43|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||130.43|101.10|
91518387|NCT05554237|182911041|OTHER||Ratio of adjusted geometric mean|140.44|||||TWO_SIDED|90.0|104.17|189.34|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||189.34|104.17|
91518388|NCT05554237|182911041|OTHER||Ratio of adjusted geometric mean|101.46||||||90.0|90.79|113.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||113.39|90.79|
91518389|NCT05554237|182911041|OTHER||Ratio of adjusted geometric means|123.2|||||TWO_SIDED|90.0|110.25|137.67|||||Model is a mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||137.67|110.25|
91518390|NCT02701985|182911075|OTHER||Difference in Response Rates|4.27||||0.7955|TWO_SIDED|95.0|-20.55|29.08|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 3 point reduction from baseline in ESSDAI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% confidence interval (CI) are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||29.08|-20.55|0.7955
91518391|NCT02701985|182911076|OTHER||Difference in Response Rates|1.14||||0.9877|TWO_SIDED|95.0|-23.92|26.19|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 1 point reduction from baseline in ESSPRI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% CI are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||26.19|-23.92|0.9877
91518392|NCT02701985|182911077|SUPERIORITY||Difference in Adjusted Means|-0.13||||0.8905|TWO_SIDED|95.0|-2.04|1.78|||Mixed Model for Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||1.78|-2.04|0.8905
91769960|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
91518393|NCT02701985|182911078|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.6077|TWO_SIDED|95.0|-1.08|0.64|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.64|-1.08|0.6077
91518394|NCT02701985|182911079|SUPERIORITY||Difference in Adjusted Means|-2.06||||0.2846||95.0|-5.87|1.75|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||1.75|-5.87|0.2846
91518395|NCT02701985|182911080|SUPERIORITY||Difference in Adjusted Means|-0.33||||0.8134||95.0|-2.43|3.08|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||3.08|-2.43|0.8134
91518396|NCT02701985|182911084|SUPERIORITY||Median Difference (Final Values)|0.87||||0.4266||95.0|-1.3|3.03|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||3.03|-1.30|0.4266
91518397|NCT02701985|182911085|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6429||95.0|-0.21|0.34|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.34|-0.21|0.6429
91518398|NCT01640808|182911095|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.351|TWO_SIDED|95.0|0.72|1.124||A two-sided significance level was set at 0.05. Adjustment of multiplicity considering interim analysis is conducted by the Lan DeMets' method of α consumption function.|Log Rank|||||1.124|0.720|0.351
91518399|NCT01640808|182911096|SUPERIORITY||Hazard Ratio (HR)|0.875||||0.222|TWO_SIDED|95.0|0.706|1.085||A two-sided significance level was set at 0.05.|Log Rank|||||1.085|0.706|0.222
91518400|NCT01640808|182911097|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.279|TWO_SIDED|95.0|0.703|1.108||A two-sided significance level was set at 0.05.|Log Rank|||||1.108|0.703|0.279
91518401|NCT00989768|182911098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.36|<|0.0001||95.0|||||t-test, 2 sided|||In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.||||<0.0001
91518402|NCT00989768|182911099|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91518403|NCT00989768|182911100|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
91518404|NCT00989768|182911101|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
91518405|NCT01362140|182911111|SUPERIORITY_OR_OTHER|||||||0.008|||||||Chi-squared|||"The primary hypothesis to be tested was that the percentage of participants with at least~1 RBC transfusion from week 5 to the EOTP was lower in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if the incidence of RBC transfusion in the darbepoetin alfa group was lower and had a p-value \< 0.05 from a 2-sided Chi-square test."||||0.008
91706038|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.65|STANDARD_ERROR_OF_MEAN|1.141||0.1506|TWO_SIDED|90.0|-0.24|3.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.53|-0.24|0.1506
91706039|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.116||0.78|TWO_SIDED|90.0|-2.16|1.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.53|-2.16|0.7800
91769961|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
91518406|NCT01362140|182911112|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|The overall 2-sided CMH test with IPSS score as stratification factor.||If the primary hypothesis was confirmed, the secondary hypothesis to be tested was that the percentage of participants achieving an IWG erythroid response during the 24-week double-blind treatment period was greater in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if erythroid response was higher in the darbepoetin alfa group and the p-value was \< 0.05 from a 2-sided Cochran-Mantel-Haenszel test using the IPSS as a stratification factor.||||0.017
91518407|NCT03998618|182911156|SUPERIORITY||partial correlation|0.12||||0.018|TWO_SIDED|95.0|-0.01|0.25||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 234. multiply imputed data were used in analyses.||||0.25|-0.01|.018
91518408|NCT03998618|182911157|SUPERIORITY||partial correlation|0.11||||0.037|TWO_SIDED|95.0|-0.02|0.24||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.24|-0.02|.037
91518409|NCT03998618|182911158|SUPERIORITY||partial correlation|0.07||||0.355|TWO_SIDED|95.0|-0.06|0.2||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.20|-0.06|.355
91518410|NCT03998618|182911159|SUPERIORITY||partial correlation|0.08||||0.167|TWO_SIDED|95.0|-0.04|0.21||P-value for study group x time interaction for physical quality of life. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.21|-0.04|.167
91518411|NCT03998618|182911159|SUPERIORITY||partial correlation|0.09||||0.105|TWO_SIDED|95.0|-0.03|0.22||P-value for study group x time interaction for social/family quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.03|.105
91518412|NCT03998618|182911159|SUPERIORITY||partial correlation|0.09||||0.142|TWO_SIDED|95.0|-0.04|0.22||P-value for study group x time interaction for emotional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.04|.142
91518413|NCT03998618|182911159|SUPERIORITY||partial correlation|0.13||||0.006|TWO_SIDED|95.0|0.01|0.26||P-value for study group x time interaction for functional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.26|0.01|.006
91518414|NCT02308748|182911178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8||||0.025|TWO_SIDED|95.0|-25.2|-14.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.3|-25.2|0.025
91518415|NCT02308748|182911178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7||||0.025|TWO_SIDED|95.0|-25.2|-14.1||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.1|-25.2|0.025
91518416|NCT02308748|182911178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.2||||0.025|TWO_SIDED|95.0|-28.0|-18.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-18.3|-28.0|0.025
91518417|NCT02308748|182911178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5||||0.025|TWO_SIDED|95.0|-25.5|-15.5||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-15.5|-25.5|0.025
91518418|NCT02308748|182911179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.025|TWO_SIDED|95.0|-1.0|6.7||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||||6.7|-1|0.025
91706040|NCT00938587|183306668|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.13||0.0883|TWO_SIDED|90.0|-3.8|-0.07|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-3.80|0.0883
91706041|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|4.48||0.0599|TWO_SIDED|90.0|-15.87|-1.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-1.07|-15.87|0.0599
91769962|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|55.0|||||TWO_SIDED|90.0|19.7|77.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||77.6|19.7|
91518419|NCT01994954|182911181|SUPERIORITY||||||<|0.03||||||A two-sided P-value of 0.05 or less was interpreted as a statistically significant result.|t-test, 2 sided|||The trial was designed to have 97% power at a type I error rate of 5% to detect a 25% intervention effect with respect to the primary outcome. this was done using an independent sample t-test. P-value was calculated, and a p-value of 0.05 or less was interpreted as statistically significant result.||||<0.03
91518420|NCT01994954|182911182|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Power calculations were based on the primary analysis (t-test comparing changes). A sample size of 130 would have given 80% power, with 0.05 two sided type 1 error rate, to detect a 20% absolute difference in emotional role limitation on the PedsQL v2.0, which we considered to be statistically significant.||||0.38
91518421|NCT00449176|182911186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001||95.0|-1.22|-0.47|||ANCOVA|||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.47|-1.22|<0.001
91518422|NCT01967732|182911232|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|77.43|||||TWO_SIDED|95.0|62.69|95.63|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||95.63|62.69|
91518423|NCT01967732|182911233|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|74.47|||||TWO_SIDED|95.0|61.52|90.14|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||90.14|61.52|
91518424|NCT05525494|182911234|SUPERIORITY||Adjusted Risk Ratio|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received portal (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
91769963|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|12.1|||||TWO_SIDED|90.0|-21.4|43.4||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||43.4|-21.4|
91769964|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|90.0|-29.4|36.4||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-29.4|
91518425|NCT05525494|182911234|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received text (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
91518426|NCT05525494|182911234|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received pre-appointment reminder/recall messages (portal and text) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
91518427|NCT05525494|182911234|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Adjusted risk ratio. These results compare arms which received a tailored reminder/recall messages based on their responses to a pre-commitment questionnaire (any type) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
91518428|NCT01988779|182911237|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.505|||||||ANOVA|||||||0.505
91518429|NCT01988779|182911239|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.39|||||||ANOVA|||||||0.390
91518430|NCT01988779|182911240|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.036|||||||ANOVA|||||||0.036
91518431|NCT00377403|182911242|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The a priori threshold for statistical significnace was p less than or equal to 0.05|ANOVA|Adjusted for disease severity at baseline||We used analysis of variance, controlling for disease severity at baseline to test the null hypothesis that there was no difference between study groups at this point in time.||||0.83
91518432|NCT02275065|182911243|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518433|NCT02275065|182911243|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518434|NCT02275065|182911243|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91706042|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.29|STANDARD_ERROR_OF_MEAN|4.436||0.003|TWO_SIDED|90.0|-20.61|-5.96|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.96|-20.61|0.0030
91518435|NCT02275065|182911243|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518436|NCT02275065|182911246|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91581295|NCT01160289|183052321|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.214|STANDARD_ERROR_OF_MEAN|5.349||0.178||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.178
91706043|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.63|STANDARD_ERROR_OF_MEAN|4.483||0.0053|TWO_SIDED|90.0|-20.03|-5.22|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.22|-20.03|0.0053
91518437|NCT02275065|182911246|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518438|NCT02275065|182911246|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518439|NCT02275065|182911246|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518440|NCT02275065|182911247|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518441|NCT02275065|182911247|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518442|NCT02275065|182911247|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518443|NCT02275065|182911247|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
91518444|NCT00417079|182911261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.|Log Rank|Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)||The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.||||<0.0001
91518445|NCT00417079|182911262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
91518446|NCT00417079|182911263|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Chi-squared|||||||0.0005
91518447|NCT00417079|182911264|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61|||<|0.0001|TWO_SIDED|95.0|0.49|0.76|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.76|0.49|<0.0001
91518448|NCT00417079|182911265|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.001|TWO_SIDED|95.0|0.63|0.9|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.90|0.63|0.0010
91518449|NCT00417079|182911266|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
91706044|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.44|STANDARD_ERROR_OF_MEAN|4.445||0.0001|TWO_SIDED|90.0|-24.78|-10.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-10.10|-24.78|0.0001
91518450|NCT00417079|182911267|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.5192|TWO_SIDED|95.0|0.69|1.19|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||1.19|0.69|0.5192
91518451|NCT00417079|182911268|SUPERIORITY_OR_OTHER|||||||0.6286||95.0|||||Chi-squared|||||||0.6286
91518452|NCT00833638|182911269|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.086
91518453|NCT00833638|182911269|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.006
91518454|NCT00833638|182911269|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for day \<=3. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.019
91518455|NCT00833638|182911269|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for day \<=2. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.022
91518456|NCT00833638|182911269|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value for day \<=1. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.573
91518457|NCT00833638|182911270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.03|||<|0.001|TWO_SIDED|95.0|5.72|18.34||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||18.34|5.72|<0.001
91518458|NCT00833638|182911270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.001|TWO_SIDED|95.0|6.48|19.12||No adjustment for multiplicity.|ANCOVA|Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg."||19.12|6.48|<0.001
91706045|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.15|STANDARD_ERROR_OF_MEAN|4.427||0.3492|TWO_SIDED|90.0|-11.46|3.16|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.16|-11.46|0.3492
91706046|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.68|STANDARD_ERROR_OF_MEAN|4.661||0.0389|TWO_SIDED|90.0|-17.38|-1.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure||-1.98|-17.38|0.0389
91581296|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.472||0.867||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.867
91581297|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.039|STANDARD_ERROR_OF_MEAN|0.458||0.931||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.931
91518459|NCT00833638|182911271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|8.51|22.29||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.29|8.51|<0.001
91518460|NCT00833638|182911271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.41|||<|0.001|TWO_SIDED|95.0|13.5|27.31||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg."||27.31|13.50|<0.001
91518461|NCT00833638|182911272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.27|||<|0.001|TWO_SIDED|95.0|6.83|21.71||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.71|6.83|<0.001
91518462|NCT00833638|182911272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.54|||<|0.001|TWO_SIDED|95.0|13.07|28.01||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg."||28.01|13.07|<0.001
91518463|NCT00833638|182911273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.24|||<|0.001|TWO_SIDED|95.0|6.42|22.06||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.06|6.42|<0.001
91518464|NCT00833638|182911273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.81|||<|0.001|TWO_SIDED|95.0|13.94|29.67||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg."||29.67|13.94|<0.001
91518465|NCT00833638|182911274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.92|||<|0.001|TWO_SIDED|95.0|6.3|21.55||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.55|6.30|<0.001
91518466|NCT00833638|182911274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|||<|0.001|TWO_SIDED|95.0|11.4|26.75||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg."||26.75|11.40|<0.001
91706047|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|4.49||0.0142|TWO_SIDED|90.0|-18.51|-3.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-3.68|-18.51|0.0142
91518467|NCT00833638|182911275|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.301
91518468|NCT00833638|182911275|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.046
91518469|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518470|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518471|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91769965|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|45.5|||||TWO_SIDED|90.0|17.1|69.0||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||69.0|17.1|
91518472|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518473|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518474|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518475|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
91518476|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.001
91518477|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
91518478|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
91518479|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
91518480|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.009
91518481|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.038
91518482|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518483|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518484|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518485|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518486|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518487|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518488|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518489|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518490|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518491|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518492|NCT00833638|182911276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518493|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.003
91518494|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.008
91518495|NCT00833638|182911276|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value for day \<=1. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.246
91518496|NCT00833638|182911277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.05|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518497|NCT00833638|182911278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518498|NCT00833638|182911279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91581298|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.652|STANDARD_ERROR_OF_MEAN|0.46||0.158||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.158
91706048|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.51|STANDARD_ERROR_OF_MEAN|4.612||0.0037|TWO_SIDED|90.0|-21.13|-5.89|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.89|-21.13|0.0037
91518499|NCT00833638|182911280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.11|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
91518500|NCT00127608|182911300|NON_INFERIORITY|The mean viral load between samples stored in liquid and samples stored dry was compared.|Geometric Mean Ratio|0.33|||<|0.0001|||||||ANOVA|Tukey adjustments were made for all 2 by 2 comparisons.|The Geometric Mean Ratio of the viral load was calculated for dry over liquid storage condition.|||||<0.0001
91518501|NCT00127608|182911301|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle fluid)|Mean Difference (Final Values)|-0.4451||||0.0038||95.0|-0.769|-0.1213|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1213|-0.7690|0.0038
91518502|NCT00127608|182911301|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle swab)|Median Difference (Final Values)|-0.432||||0.006|TWO_SIDED|95.0|-0.7605|-0.1035|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1035|-0.7605|0.0060
91518503|NCT00127608|182911301|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab)|Mean Difference (Final Values)|0.00132||||0.9952|TWO_SIDED|95.0|-0.3171|0.3435|||ANOVA|Tukey adjustments were made for the comparison.||||0.3435|-0.3171|0.9952
91518504|NCT00127608|182911301|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|Geometric mean ratio|0.36|||||TWO_SIDED|95.0|0.17|0.76|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle fluid)||0.76|0.17|
91518505|NCT00127608|182911301|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle swab)|Geometric mean Ratio|0.37|||||TWO_SIDED|95.0|0.17|0.79|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle swab)||0.79|0.17|
91518506|NCT00127608|182911301|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|Geometric mean Ratio|1.0|||||TWO_SIDED|95.0|0.48|2.21|||ANOVA|||Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)||2.21|0.48|
91518507|NCT01712009|182911313|SUPERIORITY_OR_OTHER||Difference|-6.3|||||TWO_SIDED|95.0|-16.7|4.1|||||Naproxen minus No Prophylaxis|||4.1|-16.7|
91518508|NCT01712009|182911313|SUPERIORITY_OR_OTHER||Difference|-4.1|||||TWO_SIDED|95.0|-14.5|6.3|||||Loratadine minus No Prophylaxis|||6.3|-14.5|
91518509|NCT01712009|182911313|SUPERIORITY_OR_OTHER||Difference|2.2|||||TWO_SIDED|95.0|-8.0|12.4|||||Loratadine minus Naproxen|||12.4|-8.0|
91518510|NCT01712009|182911314|SUPERIORITY_OR_OTHER||Difference|-4.2|||||TWO_SIDED|95.0|-14.4|6.0|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||6.0|-14.4|
91518511|NCT01712009|182911314|SUPERIORITY_OR_OTHER||Difference|-2.4|||||TWO_SIDED|95.0|-12.5|7.8|||||Loratadine minus No Prophylaxis|Difference across all treatment cyces||7.8|-12.5|
91518512|NCT01712009|182911314|SUPERIORITY_OR_OTHER||Difference|1.8|||||TWO_SIDED|95.0|-8.3|12.0|||||Loratadine minus Naproxen|Dfference across all treatment cycles||12.0|-8.3|
91518513|NCT01712009|182911315|SUPERIORITY_OR_OTHER||Difference|-1.7|||||TWO_SIDED|95.0|-6.5|3.2|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||3.2|-6.5|
91518514|NCT01712009|182911315|SUPERIORITY_OR_OTHER||Difference|-1.3|||||TWO_SIDED|95.0|-6.1|3.6|||||Loratadine minus No Prophylaxis|Difference across all cycles||3.6|-6.1|
91518515|NCT01712009|182911315|SUPERIORITY_OR_OTHER||Difference|0.4|||||TWO_SIDED|95.0|-4.1|4.9|||||Loratadine minus Naproxen|Difference across all cycles||4.9|-4.1|
91518516|NCT01712009|182911316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0881|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.0|-0.7|0.0881
91518517|NCT01712009|182911316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_DEVIATION|0.2||0.0443|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-0.7|0.0443
91518518|NCT01712009|182911316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8007|TWO_SIDED|95.0|-0.4|0.3|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.3|-0.4|0.8007
91518519|NCT01712009|182911317|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1466|TWO_SIDED|95.0|-1.1|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-1.1|0.1466
91518520|NCT01712009|182911317|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0411|TWO_SIDED|95.0|-1.3|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-1.3|0.0411
91518521|NCT01712009|182911317|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5689|TWO_SIDED|95.0|-0.8|0.5|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.5|-0.8|0.5689
91518522|NCT01712009|182911318|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0775||95.0|-3.0|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-3.0|0.0775
91518523|NCT01712009|182911318|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0329|TWO_SIDED|95.0|-3.1|-0.1|||ANCOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.1|-3.1|0.0329
91518524|NCT01712009|182911318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7572|TWO_SIDED|95.0|-1.7|1.2|||ANOVA||Loratadine minus Naproxen|Difference across all treatment groups||1.2|-1.7|0.7572
91518525|NCT01111123|182911344|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CI of 95%|Log Rank|||Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.||||<0.05
91518526|NCT01111123|182911345|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups||||<0.05
91706049|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-14.93|STANDARD_ERROR_OF_MEAN|4.447||0.0009|TWO_SIDED|90.0|-22.27|-7.58|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-7.58|-22.27|0.0009
91706050|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.83|STANDARD_ERROR_OF_MEAN|4.484||0.3939|TWO_SIDED|90.0|-11.23|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-11.23|0.3939
91706051|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.54|STANDARD_ERROR_OF_MEAN|4.595||0.0127|TWO_SIDED|90.0|3.95|19.13|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||19.13|3.95|0.0127
91706052|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|4.49||0.9425|TWO_SIDED|90.0|-7.09|7.74|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.74|-7.09|0.9425
91706053|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.08|STANDARD_ERROR_OF_MEAN|4.544||0.0155|TWO_SIDED|90.0|3.58|18.59|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||18.59|3.58|0.0155
91706054|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|4.447||0.9757|TWO_SIDED|90.0|-7.48|7.21|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.21|-7.48|0.9757
91706055|NCT00938587|183306669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|4.484||0.9184|TWO_SIDED|90.0|-7.86|6.94|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||6.94|-7.86|0.9184
91518527|NCT04333420|182911346|SUPERIORITY||LS means difference|-16.4||||0.3677|TWO_SIDED|95.0|-53.2|20.3|||Linear repeated measures model|||||20.3|-53.2|0.3677
91518528|NCT04333420|182911347|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.0941|TWO_SIDED|95.0|0.502|1.056|||Regression, Cox|including stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by site; 61 patients from sites with no events (no death) or from single patient sites with death factually make no contribution to the analysis outcome.||1.056|0.502|0.0941
91518529|NCT04333420|182911347|SUPERIORITY||Hazard Ratio (HR)|0.674||||0.0266|TWO_SIDED|95.0|0.476|0.955|||Regression, Cox|Without stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) without stratification by site; Post-hoc analysis||0.955|0.476|0.0266
91518530|NCT04333420|182911347|SUPERIORITY||Hazard Ratio (HR)|0.648||||0.0181|TWO_SIDED|95.0|0.453|0.929|||Regression, Cox|Including random effect for site (frailty model)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including random effect for site (frailty model); Post-hoc analysis||0.929|0.453|0.0181
91518531|NCT04333420|182911347|SUPERIORITY||Hazard Ratio (HR)|0.613||||0.0067|TWO_SIDED|95.0|0.43|0.873|||Regression, Cox|Including stratification by country||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by country; Post-hoc analysis||0.873|0.430|0.0067
91706056|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2403|TWO_SIDED|90.0|-0.38|0.06|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.38|0.2403
91706057|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.027|TWO_SIDED|90.0|-0.52|-0.08|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.08|-0.52|0.0270
91518532|NCT04333420|182911347|SUPERIORITY||Risk Difference (RD)|-11.0||||0.0293|TWO_SIDED|95.0|-20.8|-1.2|||Regression, Logistic|Multiple imputation of missing values|Risk difference and lower/upper limit of the Confidence Interval are given in percent|Sensitivity analysis; 369 patients were included in this analysis including the patient that was randomized in error and not treated. Missing values were imputed by multiple imputation.||-1.2|-20.8|0.0293
91518533|NCT04333420|182911347|SUPERIORITY|||||||0.0407|||||||Log Rank|||Post-hoc analysis||||0.0407
91518534|NCT04333420|182911348|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.6494|TWO_SIDED|95.0|0.103|4.135|||Regression, Cox|Covariate: Treatment (IFX-1 + BSC)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death)||4.135|0.103|0.6494
91706058|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.133||0.3139|TWO_SIDED|90.0|-0.36|0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.09|-0.36|0.3139
91706059|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.134||0.0415|TWO_SIDED|90.0|-0.5|-0.05|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.05|-0.50|0.0415
91518535|NCT04333420|182911352|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0815|TWO_SIDED|95.0|0.519|1.039|||Regression, Cox|||Cox proportional hazards regression model with outcome 60-day all-cause mortality (censored time to event variable with event = Death); Covariate: Treatment (IFX-1 + SOC)||1.039|0.519|0.0815
91518536|NCT04333420|182911353|SUPERIORITY||Risk Difference (RD)|7.352||||0.1553|TWO_SIDED|95.0|-2.762|17.465|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 15||17.465|-2.762|0.1553
91518537|NCT04333420|182911353|SUPERIORITY||Risk Difference (RD)|8.078||||0.1181|TWO_SIDED|95.0|-1.968|18.125|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 28||18.125|-1.968|0.1181
91518538|NCT04333420|182911354|SUPERIORITY||Risk Difference (RD)|-2.081||||0.4105|TWO_SIDED|95.0|-6.949|2.787|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent|||2.787|-6.949|0.4105
91518539|NCT04333420|182911355|SUPERIORITY||Hazard Ratio (HR)|0.539||||0.0422|TWO_SIDED|95.0|0.297|0.978||p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.|Regression, Cox|Covariate: Treatment (IFX-1 + SOC)||||0.978|0.297|0.0422
91518540|NCT00160680|182911358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|||=|0.667|TWO_SIDED|95.0|-0.96|1.5|||ANCOVA|||||1.50|-0.96|=0.667
91518541|NCT03595579|182911376|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91518542|NCT03595579|182911377|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
91518543|NCT05090709|182911382|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
91518544|NCT05090709|182911382|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
91518545|NCT05090709|182911387|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
91706060|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8585|TWO_SIDED|90.0|-0.2|0.25|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.25|-0.20|0.8585
91706061|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7284|TWO_SIDED|90.0|-0.28|0.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.18|-0.28|0.7284
91706062|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.0171|TWO_SIDED|90.0|-0.55|-0.1|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.10|-0.55|0.0171
91706063|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2277|TWO_SIDED|90.0|-0.39|0.06|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.39|0.2277
91518546|NCT05090709|182911387|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
91518547|NCT05090709|182911392|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
91518548|NCT05090709|182911392|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
91518549|NCT05090709|182911397|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518550|NCT05090709|182911397|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518551|NCT05090709|182911399|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||< 0.05
91518552|NCT05090709|182911399|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||> 0.05
91518553|NCT05090709|182911404|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
91518554|NCT05090709|182911404|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
91706064|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.134||0.0013|TWO_SIDED|90.0|-0.67|-0.22|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.22|-0.67|0.0013
91706065|NCT00938587|183306670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.135||0.3908|TWO_SIDED|90.0|-0.34|0.11|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.11|-0.34|0.3908
91706066|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|7.093||0.6067|TWO_SIDED|90.0|-15.43|8.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.10|-15.43|0.6067
91706067|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.55|STANDARD_ERROR_OF_MEAN|7.101||0.1816|TWO_SIDED|90.0|-21.32|2.23|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.23|-21.32|0.1816
91706068|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.84|STANDARD_ERROR_OF_MEAN|7.029||0.6873|TWO_SIDED|90.0|-14.5|8.82|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.82|-14.50|0.6873
91706069|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.052||0.2188|TWO_SIDED|90.0|-20.42|2.98|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.98|-20.42|0.2188
91706070|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.83|STANDARD_ERROR_OF_MEAN|7.024||0.9067|TWO_SIDED|90.0|-10.82|12.47|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||12.47|-10.82|0.9067
91706071|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.02|STANDARD_ERROR_OF_MEAN|7.254||0.5803|TWO_SIDED|90.0|-16.05|8.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.00|-16.05|0.5803
91706072|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.29|STANDARD_ERROR_OF_MEAN|7.156||0.249|TWO_SIDED|90.0|-20.16|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-20.16|0.2490
91706073|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.62|STANDARD_ERROR_OF_MEAN|7.178||0.1081|TWO_SIDED|90.0|-23.52|0.28|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.28|-23.52|0.1081
91706074|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.89|STANDARD_ERROR_OF_MEAN|7.098||0.0271|TWO_SIDED|90.0|-27.66|-4.12|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-4.12|-27.66|0.0271
91706075|NCT00938587|183306671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|7.121||0.2881|TWO_SIDED|90.0|-19.41|4.21|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.21|-19.41|0.2881
91706076|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|7.059||0.3579|TWO_SIDED|90.0|-18.23|5.19|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.19|-18.23|0.3579
91706077|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.55|STANDARD_ERROR_OF_MEAN|7.046||0.2274|TWO_SIDED|90.0|-20.24|3.14|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.14|-20.24|0.2274
91706078|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.15|STANDARD_ERROR_OF_MEAN|6.973||0.1482|TWO_SIDED|90.0|-21.72|1.41|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.41|-21.72|0.1482
91706079|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.19|STANDARD_ERROR_OF_MEAN|6.962||0.0828|TWO_SIDED|90.0|-23.74|-0.64|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.64|-23.74|0.0828
91706080|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|6.953||0.6021|TWO_SIDED|90.0|-15.17|7.9|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.90|-15.17|0.6021
91706081|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|7.213||0.7528|TWO_SIDED|90.0|-14.24|9.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.68|-14.24|0.7528
91706082|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.17|STANDARD_ERROR_OF_MEAN|7.1||0.2523|TWO_SIDED|90.0|-19.94|3.6|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.60|-19.94|0.2523
91706083|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.63|STANDARD_ERROR_OF_MEAN|7.118||0.1049|TWO_SIDED|90.0|-23.43|0.17|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.17|-23.43|0.1049
91706084|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.53|STANDARD_ERROR_OF_MEAN|7.006||0.0138|TWO_SIDED|90.0|-29.14|-5.91|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.91|-29.14|0.0138
91706085|NCT00938587|183306672|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.36|STANDARD_ERROR_OF_MEAN|7.052||0.1873|TWO_SIDED|90.0|-21.05|2.34|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.34|-21.05|0.1873
91518555|NCT05090709|182911409|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91706086|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.54|STANDARD_ERROR_OF_MEAN|5.339||0.509|TWO_SIDED|90.0|-12.4|5.32|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.32|-12.40|0.5090
91706087|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.89|STANDARD_ERROR_OF_MEAN|5.354||0.0998|TWO_SIDED|90.0|-17.78|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-17.78|0.0998
91518556|NCT05090709|182911409|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518557|NCT05090709|182911414|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518558|NCT05090709|182911414|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518559|NCT05090709|182911419|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
91518560|NCT05090709|182911419|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518561|NCT05090709|182911424|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91706088|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|5.282||0.8866|TWO_SIDED|90.0|-9.52|8.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.01|-9.52|0.8866
91769966|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|1.9|63.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||63.4|1.9|
91769967|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|14.5|||||TWO_SIDED|90.0|-21.4|47.0||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||47.0|-21.4|
91518562|NCT05090709|182911424|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
91518563|NCT05090709|182911429|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518564|NCT05090709|182911429|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
91518565|NCT05090709|182911434|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
91518566|NCT05090709|182911434|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
91524189|NCT01216163|182923479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.96||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.96|0.78|<0.001
91769968|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|24.5|||||TWO_SIDED|90.0|-11.8|54.9||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-11.8|
91581299|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.612|STANDARD_ERROR_OF_MEAN|0.447||0.172||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.172
91706089|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.11|STANDARD_ERROR_OF_MEAN|5.28||0.2499|TWO_SIDED|90.0|-14.88|2.66|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.66|-14.88|0.2499
91706090|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|5.283||0.5995|TWO_SIDED|90.0|-5.99|11.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||11.55|-5.99|0.5995
91706091|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|5.429||0.9117|TWO_SIDED|90.0|-8.4|9.61|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.61|-8.40|0.9117
91706092|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.91|STANDARD_ERROR_OF_MEAN|5.381||0.0684|TWO_SIDED|90.0|-18.84|-0.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.98|-18.84|0.0684
91706093|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.366||0.2292|TWO_SIDED|90.0|-15.39|2.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.42|-15.39|0.2292
91706094|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.0|STANDARD_ERROR_OF_MEAN|5.308||0.0018|TWO_SIDED|90.0|-25.81|-8.19|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-8.19|-25.81|0.0018
91706095|NCT00938587|183306673|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.09|STANDARD_ERROR_OF_MEAN|5.337||0.1867|TWO_SIDED|90.0|-15.95|1.76|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.76|-15.95|0.1867
91518567|NCT03775200|182911435|OTHER|For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.|Least Mean Square Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.86|<|0.05|TWO_SIDED|95.0|-10.2|-2.9|||Mixed Models Analysis|Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.|LSM difference of COMP360 25 mg compared to COMP360 1 mg.|The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.||-2.9|-10.2|<0.05
91706096|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|2.708||0.9624|TWO_SIDED|90.0|-4.64|4.38|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using analysis of covariance (ANCOVA) where treatment as fixed effect, baseline as the covariate.||4.38|-4.64|0.9624
91518568|NCT03775200|182911436|OTHER||Least Mean Square Difference|-5.6|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|95.0|-9.4|-1.8|||Mixed Models Analysis|Hypothetical strategy estimand - MNAR and MAR imputation for missing data.||Sensitivity analysis of the primary endpoint using the per-protocol analysis set.||-1.8|-9.4|<0.05
91518569|NCT01644734|182911440|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no change in the total CAT score between baseline and after 3 months.||||<0.001
91518570|NCT02858050|182911445|OTHER|||||||0.548306|||||||Chi-squared|||||||0.548306
91518571|NCT02157779|182911449|SUPERIORITY||Least Squares Mean Difference|-5.68||||0.017|TWO_SIDED|95.0|-10.32|-1.01||Threshold for statistical significance was 0.025.|ANCOVA|Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the HLM analyses.||-1.01|-10.32|.017
91706097|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|2.65||0.9493|TWO_SIDED|90.0|-4.24|4.58|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.58|-4.24|0.9493
91706098|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.46|STANDARD_ERROR_OF_MEAN|2.738||0.21|TWO_SIDED|90.0|-1.1|8.02|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.02|-1.10|0.2100
91706099|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.651||0.1602|TWO_SIDED|90.0|-0.66|8.18|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.18|-0.66|0.1602
91769969|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|-4.5|||||TWO_SIDED|90.0|-40.4|32.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||32.3|-40.4|
91769970|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-23.7|48.2||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.2|-23.7|
91769971|NCT02201524|183427028|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-28.0|49.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|-28.0|
91706100|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.59|STANDARD_ERROR_OF_MEAN|2.71||0.1892|TWO_SIDED|90.0|-0.92|8.1|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.10|-0.92|0.1892
91706101|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|2.781||0.7899|TWO_SIDED|90.0|-3.89|5.38|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.38|-3.89|0.7899
91706102|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.96|STANDARD_ERROR_OF_MEAN|2.719||0.149|TWO_SIDED|90.0|-0.56|8.49|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.49|-0.56|0.1490
91706103|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.766||0.6238|TWO_SIDED|90.0|-5.97|3.24|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.24|-5.97|0.6238
91706104|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|2.699||0.4933|TWO_SIDED|90.0|-2.64|6.35|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.35|-2.64|0.4933
91706105|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|2.739||0.4445|TWO_SIDED|90.0|-6.67|2.46|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.46|-6.67|0.4445
91706106|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.51|STANDARD_ERROR_OF_MEAN|2.897||0.2288|TWO_SIDED|90.0|-1.31|8.34|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.34|-1.31|0.2288
91706107|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|2.844||0.098|TWO_SIDED|90.0|0.03|9.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||9.50|0.03|0.0980
91518572|NCT02157779|182911450|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.19|TWO_SIDED|95.0|-0.33|0.06||The threshold for statistical significance was p=0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||Population Description: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|0.06|-0.33|0.19
91518573|NCT02157779|182911451|SUPERIORITY||Least Squares Mean Difference|-0.42||||0.011|TWO_SIDED|95.0|-0.75|-0.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|-0.09|-0.75|.011
91518574|NCT02157779|182911452|SUPERIORITY||Least Squares Mean Difference|-0.26||||0.16|TWO_SIDED|95.0|-0.63|0.11||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.||0.11|-0.63|0.16
91581300|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.223|STANDARD_ERROR_OF_MEAN|0.401||0.579||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.579
91706108|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|STANDARD_ERROR_OF_MEAN|2.941||0.0637|TWO_SIDED|90.0|0.64|10.43|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||10.43|0.64|0.0637
91706109|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|2.831||0.019|TWO_SIDED|90.0|2.07|11.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.50|2.07|0.0190
91706110|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.02|STANDARD_ERROR_OF_MEAN|2.903||0.4886|TWO_SIDED|90.0|-2.81|6.86|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.86|-2.81|0.4886
91706111|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.879||0.9951|TWO_SIDED|90.0|-3.12|3.14|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.14|-3.12|0.9951
91706112|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|1.818||0.4721|TWO_SIDED|90.0|-1.71|4.34|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.34|-1.71|0.4721
91769972|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
91706113|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|1.879||0.6835|TWO_SIDED|90.0|-3.9|2.36|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.36|-3.90|0.6835
91706114|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|1.818||0.7701|TWO_SIDED|90.0|-2.49|3.56|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.56|-2.49|0.7701
91706115|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.831||0.671|TWO_SIDED|90.0|-3.83|2.27|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.27|-3.83|0.6710
91706116|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.827||0.2886|TWO_SIDED|90.0|-1.69|7.73|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.73|-1.69|0.2886
91706117|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.22|STANDARD_ERROR_OF_MEAN|2.784||0.134|TWO_SIDED|90.0|-0.42|8.86|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.86|-0.42|0.1340
91706118|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|2.83||0.2563|TWO_SIDED|90.0|-1.48|7.95|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.95|-1.48|0.2563
91706119|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.43|STANDARD_ERROR_OF_MEAN|2.771||0.1138|TWO_SIDED|90.0|-0.18|9.05|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.05|-0.18|0.1138
91706120|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|2.793||0.9386|TWO_SIDED|90.0|-4.44|4.87|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.87|-4.44|0.9386
91706121|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.701||0.8814|TWO_SIDED|90.0|-4.09|4.9|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.90|-4.09|0.8814
91706122|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.98|STANDARD_ERROR_OF_MEAN|2.64||0.1363|TWO_SIDED|90.0|-0.42|8.37|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.37|-0.42|0.1363
91706123|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|2.682||0.7864|TWO_SIDED|90.0|-3.74|5.2|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.20|-3.74|0.7864
91706124|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.619||0.1048|TWO_SIDED|90.0|-0.06|8.66|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.66|-0.06|0.1048
91706125|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.643||0.9024|TWO_SIDED|90.0|-4.08|4.73|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.73|-4.08|0.9024
91706126|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|3.819||0.4954|TWO_SIDED|90.0|-3.74|8.98|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.98|-3.74|0.4954
91706127|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.14|STANDARD_ERROR_OF_MEAN|3.735||0.1729|TWO_SIDED|90.0|-1.08|11.36|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.36|-1.08|0.1729
91706128|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21|STANDARD_ERROR_OF_MEAN|3.82||0.565|TWO_SIDED|90.0|-4.15|8.57|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.57|-4.15|0.5650
91706129|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|3.73||0.2087|TWO_SIDED|90.0|-1.48|10.94|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.94|-1.48|0.2087
91706130|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|3.771||0.9139|TWO_SIDED|90.0|-6.69|5.87|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.87|-6.69|0.9139
91706131|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|3.371||0.6559|TWO_SIDED|90.0|-4.11|7.12|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.12|-4.11|0.6559
91706132|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.15|STANDARD_ERROR_OF_MEAN|3.315||0.7304|TWO_SIDED|90.0|-4.37|6.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.67|-4.37|0.7304
91769973|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
91706133|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.64|STANDARD_ERROR_OF_MEAN|3.369||0.1729|TWO_SIDED|90.0|-0.98|10.25|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.25|-0.98|0.1729
91706134|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|3.335||0.2038|TWO_SIDED|90.0|-1.28|9.83|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.83|-1.28|0.2038
91706135|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|3.328||0.3503|TWO_SIDED|90.0|-2.41|8.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.67|-2.41|0.3503
91706136|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.29|STANDARD_ERROR_OF_MEAN|2.01||0.8875|TWO_SIDED|90.0|-3.06|3.63|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.63|-3.06|0.8875
91706137|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97|STANDARD_ERROR_OF_MEAN|1.971||0.3203|TWO_SIDED|90.0|-1.31|5.25|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.25|-1.31|0.3203
91706138|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.046||0.5232|TWO_SIDED|90.0|-2.09|4.72|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.72|-2.09|0.5232
91706139|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.971||0.1324|TWO_SIDED|90.0|-0.28|6.28|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.28|-0.28|0.1324
91706140|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|2.024||0.6134|TWO_SIDED|90.0|-2.34|4.4|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.40|-2.34|0.6134
91706141|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.26|STANDARD_ERROR_OF_MEAN|3.387||0.5059|TWO_SIDED|90.0|-3.38|7.91|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.91|-3.38|0.5059
91706142|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.44|STANDARD_ERROR_OF_MEAN|3.329||0.3042|TWO_SIDED|90.0|-2.1|8.99|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.99|-2.10|0.3042
91706143|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|3.39||0.3519|TWO_SIDED|90.0|-2.47|8.82|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.82|-2.47|0.3519
91706144|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.36|STANDARD_ERROR_OF_MEAN|3.342||0.1966|TWO_SIDED|90.0|-1.21|9.92|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.92|-1.21|0.1966
91518575|NCT02157779|182911453|SUPERIORITY||Least Squares Mean Difference|-11.65||||0.031|TWO_SIDED|95.0|-22.2|-1.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.||-1.09|-22.20|.031
91706145|NCT00938587|183306674|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.91|STANDARD_ERROR_OF_MEAN|3.345||0.786|TWO_SIDED|90.0|-4.66|6.48|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.48|-4.66|0.7860
91706146|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.286||0.109|TWO_SIDED|90.0|-0.93|0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.01|-0.93|0.1090
91706147|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.282||0.0014|TWO_SIDED|90.0|-1.38|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.38|0.0014
91706148|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.284||0.0506|TWO_SIDED|90.0|-1.03|-0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.09|-1.03|0.0506
91706149|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|90.0|-1.48|-0.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.55|-1.48|0.0004
91706150|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.281||0.7272|TWO_SIDED|90.0|-0.56|0.37|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.56|0.7272
91706151|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.296||0.0604|TWO_SIDED|90.0|-1.05|-0.07|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-1.05|0.0604
91769974|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|8.2|||||TWO_SIDED|90.0|-14.4|32.2||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||32.2|-14.4|
91769975|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-6.7|43.6||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||43.6|-6.7|
91769976|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.7|||||TWO_SIDED|90.0|-28.8|12.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||12.1|-28.8|
91769977|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|32.3|||||TWO_SIDED|90.0|5.4|55.4||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.4|5.4|
91769978|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|90.0|0.8|55.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.3|0.8|
91518576|NCT02157779|182911454|SUPERIORITY||Least Squares Mean Difference|1.56||||0.004|TWO_SIDED|95.0|0.51|2.6||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|2.60|0.51|0.004
91518577|NCT02157779|182911455|SUPERIORITY||Least Squares Mean Difference|-2.15||||0.416|TWO_SIDED|95.0|-7.37|3.07||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI|All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.||3.07|-7.37|0.416
91518578|NCT02157779|182911456|SUPERIORITY||Least Squares Mean Difference|-13.72||||0.028|TWO_SIDED|95.0|-25.94|-1.5||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the analyses.||-1.50|-25.94|0.028
91581301|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.616|STANDARD_ERROR_OF_MEAN|0.39||0.115||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.115
91769979|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-27.3|27.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||27.3|-27.3|
91769980|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|1.0|59.8||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||59.8|1.0|
91769981|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|43.3|||||TWO_SIDED|90.0|8.8|69.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||69.3|8.8|
91769982|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
91769983|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|50.0|||||TWO_SIDED|90.0|25.4|71.8||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||71.8|25.4|
91769984|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|66.7|||||TWO_SIDED|90.0|39.2|86.1||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||86.1|39.2|
91769985|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.1|||||TWO_SIDED|90.0|-36.3|18.3||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||18.3|-36.3|
91769986|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|41.8|||||TWO_SIDED|90.0|6.2|68.5||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||68.5|6.2|
91769987|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|31.8|||||TWO_SIDED|90.0|-2.9|60.5||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||60.5|-2.9|
91769988|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.9|||||TWO_SIDED|90.0|-47.8|13.7||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||13.7|-47.8|
91769989|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|-6.8|||||TWO_SIDED|90.0|-40.6|24.8||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-40.6|
91769990|NCT02201524|183427029|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-36.4|36.4||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-36.4|
91769991|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
91769992|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
91769993|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|0.5|||||TWO_SIDED|90.0|-20.7|22.8||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||22.8|-20.7|
91769994|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|1.2|||||TWO_SIDED|90.0|-20.3|24.8||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-20.3|
91769995|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-5.6|33.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-5.6|
91769996|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|15.3|61.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||61.1|15.3|
91769997|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|11.3|57.3||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||57.3|11.3|
91769998|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|60.0|||||TWO_SIDED|90.0|34.7|80.9||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||80.9|34.7|
91769999|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
91770000|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|44.4|||||TWO_SIDED|90.0|19.4|70.2||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||70.2|19.4|
91518579|NCT02157779|182911457|SUPERIORITY|||||||0.13|||||||ANOVA|GLM Repeated Measures Analysis of Variance of means grouped by sessions 1-4, 5-8, and 9-12||All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.||||0.13
91581302|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.168|STANDARD_ERROR_OF_MEAN|0.392||0.668||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.668
91770001|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|20.0|||||TWO_SIDED|90.0|-2.7|46.6||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.6|-2.7|
91770002|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|30.0|||||TWO_SIDED|90.0|6.4|56.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||56.4|6.4|
91770003|NCT02201524|183427030|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-4.9|54.9||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-4.9|
91770004|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-4.4|33.8||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-4.4|
91770005|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-5.2|32.0||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||32.0|-5.2|
91770006|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
91770007|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|21.4|||||TWO_SIDED|90.0|-3.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-3.2|
91770008|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|15.9|||||TWO_SIDED|90.0|-8.1|40.7||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||40.7|-8.1|
91770009|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|34.5|||||TWO_SIDED|90.0|7.3|59.4||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||59.4|7.3|
91770010|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-11.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-11.2|
91770011|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|31.3|||||TWO_SIDED|90.0|1.7|55.7||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.7|1.7|
91770012|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|30.1|||||TWO_SIDED|90.0|-1.2|57.4|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||57.4|-1.2|
91770013|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-6.4|52.5||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||52.5|-6.4|
91770014|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|8.7|66.7||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||66.7|8.7|
91770015|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|53.3|||||TWO_SIDED|90.0|18.5|76.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||76.6|18.5|
91770016|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|6.1|||||TWO_SIDED|90.0|-26.1|36.6||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.6|-26.1|
91770017|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|14.4|||||TWO_SIDED|90.0|-18.9|44.5||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||44.5|-18.9|
91770018|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|50.5|||||TWO_SIDED|90.0|12.9|75.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||75.3|12.9|
91770019|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|9.1|||||TWO_SIDED|90.0|-25.2|41.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||41.4|-25.2|
91770020|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|3.6|||||TWO_SIDED|90.0|-30.5|37.3||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||37.3|-30.5|
91770021|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-21.9|46.2||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.2|-21.9|
91770022|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|90.0|-33.2|34.6||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||34.6|-33.2|
91770023|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|20.5|||||TWO_SIDED|90.0|-17.6|51.9||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||51.9|-17.6|
91770024|NCT02201524|183427031|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-26.4|48.1||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.1|-26.4|
91770025|NCT02646826|183427044|SUPERIORITY|||||||0.0017|||||||ANOVA|||||||0.0017
91770026|NCT02646826|183427045|SUPERIORITY||||||<|0.44|||||||ANOVA|||||||<.44
91770027|NCT00097500|183427059|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
91518580|NCT02157779|182911458|SUPERIORITY||Least Squares Mean Difference|-0.82||||0.03|TWO_SIDED|95.0|-1.578|-0.063||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.||-0.063|-1.578|0.030
91770028|NCT00097500|183427060|SUPERIORITY_OR_OTHER|||||||0.4185||95.0|||||ANCOVA|||||||0.4185
91770029|NCT00097500|183427061|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
91770030|NCT00097500|183427061|SUPERIORITY_OR_OTHER|||||||0.1188||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1188
91770031|NCT00097500|183427062|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
91770032|NCT00097500|183427062|SUPERIORITY_OR_OTHER|||||||0.1996||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1996
91770033|NCT00097500|183427063|SUPERIORITY_OR_OTHER|||||||0.5522||95.0|||||ANCOVA|||||||0.5522
91770034|NCT00097500|183427064|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91770035|NCT00097500|183427066|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91770036|NCT00119847|183427068|SUPERIORITY||Mean Difference (Net)|-0.04||||0.34|TWO_SIDED|95.0|-0.12|0.04||p\<0.05 required for statistical significance|t-test, 2 sided|||The planned sample size of 300 subjects was chosen to provide 80% power to detect a clinically relevant difference of 0.1 in the change in α1 from baseline to 1 year between the 2 treatment groups on the basis of data from prior studies that indicated that baseline levels of α1 would be 1.0 with a common SD of 0.2.||0.04|-0.12|0.34
91770037|NCT00119847|183427069|SUPERIORITY||Mean Difference (Net)|3.0||||0.45|TWO_SIDED|95.0|-4.8|10.7||p\<0.01 required for statistical significance|t-test, 2 sided|||||10.7|-4.8|0.45
91770038|NCT00119847|183427070|SUPERIORITY||Mean Difference (Net)|2.2||||0.23|TWO_SIDED|95.0|-1.4|5.9||p\<0.01 required for statistical significance|t-test, 2 sided|||||5.9|-1.4|0.23
91770039|NCT01553084|183427076|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3623|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|||Combination NRT will be compared statististically versus Nicotine patch only (the reference or control group).||1.7|0.8|.3623
91770040|NCT01553084|183427076|SUPERIORITY||Odds Ratio (OR)|0.9||||0.1947|TWO_SIDED|95.0|0.6|1.2|||Regression, Logistic|||Varenicline will be compared statististically versus Nicotine patch only (the reference or control group).||1.2|0.6|.1947
91770041|NCT01553084|183427077|SUPERIORITY||Hazard Ratio (HR)|0.915||||0.3613|TWO_SIDED|95.0|0.756|1.107|||Regression, Cox|||||1.107|.756|.3613
91770042|NCT01553084|183427077|SUPERIORITY||Hazard Ratio (HR)|0.943||||0.5503|TWO_SIDED|95.0|0.779|1.142|||Regression, Cox|||||1.142|.779|.5503
91770043|NCT01553084|183427078|SUPERIORITY||Odds Ratio (OR)|1.5||||0.03|TWO_SIDED|95.0|1.1|2.2|||Regression, Logistic|||||2.2|1.1|.03
91770044|NCT01553084|183427078|SUPERIORITY||Odds Ratio (OR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Logistic|||||1.1|0.6|.19
91770045|NCT01553084|183427079|SUPERIORITY||Mean Difference (Final Values)|-0.00612|STANDARD_ERROR_OF_MEAN|0.00625||0.3282|TWO_SIDED||||||t-test, 2 sided|df=710||||||.3282
91770046|NCT00647296|183427162|SUPERIORITY||Slope|-0.606|STANDARD_ERROR_OF_MEAN|0.408||0.1385|TWO_SIDED|95.0|-1.41|0.19|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.19|-1.41|0.1385
91770047|NCT00647296|183427162|SUPERIORITY||Slope|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7718|TWO_SIDED|95.0|-0.65|0.88|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.88|-0.65|0.7718
91770048|NCT00647296|183427162|SUPERIORITY||Slope|0.401|STANDARD_ERROR_OF_MEAN|0.397||0.3146|TWO_SIDED|95.0|-0.38|1.18|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||1.18|-0.38|0.3146
91770049|NCT00647296|183427163|SUPERIORITY||Slope|0.395|STANDARD_ERROR_OF_MEAN|1.536||0.7973|TWO_SIDED|95.0|-2.61|3.4|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.40|-2.61|0.7973
91770050|NCT00647296|183427163|SUPERIORITY||Slope|2.009|STANDARD_ERROR_OF_MEAN|1.47||0.1732|TWO_SIDED|95.0|-0.87|4.89|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||4.89|-0.87|0.1732
91770051|NCT00647296|183427163|SUPERIORITY||Slope|0.451|STANDARD_ERROR_OF_MEAN|1.497||0.7635|TWO_SIDED|95.0|-2.48|3.39|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.39|-2.48|0.7635
91770052|NCT00647296|183427174|SUPERIORITY||Slope|0.263|STANDARD_ERROR_OF_MEAN|0.19||0.1772|TWO_SIDED|95.0|-0.12|0.64|||Mixed Models Analysis||50 mg/day minus 150 mg/day arm, negative direction represents worse outcome.|||0.64|-0.12|0.1772
91770053|NCT00647296|183427175|SUPERIORITY||Slope|-0.615|STANDARD_ERROR_OF_MEAN|0.73||0.4025|TWO_SIDED|95.0|-2.06|0.83|||Mixed Models Analysis||50 mg/day minus 300 mg/day treatment arm, negative direction represents worse outcome.|||0.83|-2.06|0.4025
91770054|NCT01300234|183427176|SUPERIORITY_OR_OTHER||percentage of participants|58.5|||<|0.0001|TWO_SIDED|97.5|45.8|71.3||HBeAg-positive participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach is used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||71.3|45.8|<0.0001
91770055|NCT01300234|183427176|SUPERIORITY_OR_OTHER||percentage of participants|25.6|||<|0.0001|TWO_SIDED|97.5|16.7|34.3||HBeAg-negative participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach was used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||34.3|16.7|<0.0001
91770056|NCT04879628|183427231|SUPERIORITY||Rate ratio|0.21|||||TWO_SIDED|95.0|0.08|0.56||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.56|0.08|
91770057|NCT04879628|183427231|SUPERIORITY||Rate ratio|0.11|||||TWO_SIDED|95.0|0.03|0.38||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.38|0.03|
91770058|NCT00871871|183427258|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.067|TWO_SIDED|90.0|-0.22|0.01||one-sided, alpha = 0.05|ANCOVA|||||0.01|-0.22|0.067
91770059|NCT00871871|183427259|SUPERIORITY_OR_OTHER||Least squares mean difference|1.1|||>|0.5|TWO_SIDED|90.0|0.86|1.34|||ANCOVA|||||1.34|0.86|>0.500
91770060|NCT00871871|183427260|SUPERIORITY_OR_OTHER||Least squares mean difference|0.016||||0.13|TWO_SIDED|90.0|-0.012|0.044||one-sided, alpha = 0.05|ANOVA|||||0.044|-0.012|0.130
91770061|NCT00871871|183427261|SUPERIORITY_OR_OTHER||Least squares mean difference|0.54|||>|0.5|TWO_SIDED|90.0|0.4|0.67|||ANCOVA|||||0.67|0.40|>0.500
91770062|NCT00871871|183427262|SUPERIORITY_OR_OTHER||Least squares mean difference|0.004||||0.342|TWO_SIDED|90.0|-0.023|0.014||one-sided, alpha = 0.05|ANOVA|||||0.014|-0.023|0.342
91518581|NCT02157779|182911459|SUPERIORITY||Least Squares Mean Difference|-0.085||||0.021|TWO_SIDED|95.0|-0.158|-0.011||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||-0.011|-0.158|0.021
91706152|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.285||0.0003|TWO_SIDED|90.0|-1.53|-0.59|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.59|-1.53|0.0003
91770063|NCT00871871|183427263|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0016|||>|0.5|TWO_SIDED|90.0|-0.008|0.011|||ANOVA|||||0.011|-0.008|>0.500
91770064|NCT00871871|183427264|SUPERIORITY_OR_OTHER||Least squares mean difference|0.003|||>|0.5|TWO_SIDED|90.0|-0.003|0.01|||ANOVA|||||0.010|-0.003|>0.500
91770065|NCT04612725|183427265|SUPERIORITY||LS mean difference|-1.01||||0.3824|TWO_SIDED|95.0|-3.28|1.26||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.26|-3.28|0.3824
91770066|NCT04612725|183427265|SUPERIORITY||LS mean difference|-1.79||||0.1244|TWO_SIDED|95.0|-4.09|0.5||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.50|-4.09|0.1244
91770067|NCT04612725|183427266|SUPERIORITY||LS mean difference|-2.07||||0.4016|TWO_SIDED|95.0|-6.95|2.8||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.80|-6.95|0.4016
91770068|NCT04612725|183427266|SUPERIORITY||LS mean difference|-4.36||||0.0819|TWO_SIDED|95.0|-9.28|0.56||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.56|-9.28|0.0819
91770069|NCT04612725|183427266|SUPERIORITY||LS mean difference|-2.56||||0.3314|TWO_SIDED|95.0|-7.74|2.63||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.63|-7.74|0.3314
91770070|NCT04612725|183427266|SUPERIORITY||LS mean difference|-3.74||||0.1582|TWO_SIDED|95.0|-8.95|1.47||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.47|-8.95|0.1582
91770071|NCT04612725|183427267|SUPERIORITY||LS mean difference|-1.62||||0.1995|TWO_SIDED|95.0|-4.1|0.86||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.86|-4.10|0.1995
91770072|NCT04612725|183427267|SUPERIORITY||LS mean difference|-1.76||||0.1654|TWO_SIDED|95.0|-4.25|0.73||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.73|-4.25|0.1654
91770073|NCT04612725|183427268|SUPERIORITY||percentage difference|11.72||||0.1373|TWO_SIDED|95.0|-2.37|25.82||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||25.82|-2.37|0.1373
91770074|NCT04612725|183427268|SUPERIORITY||percentage difference|10.73||||0.1697|TWO_SIDED|95.0|-3.42|24.88||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||24.88|-3.42|0.1697
91770075|NCT04612725|183427268|SUPERIORITY||percentage difference|1.03||||0.9105|TWO_SIDED|95.0|-16.9|18.96||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||18.96|-16.90|0.9105
91770076|NCT04612725|183427268|SUPERIORITY||percentage difference|9.27||||0.3389|TWO_SIDED|95.0|-9.37|27.9||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||27.90|-9.37|0.3389
91770077|NCT04612725|183427269|SUPERIORITY||LS mean difference|-1.16||||0.4203|TWO_SIDED|95.0|-4.0|1.68||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.68|-4.00|0.4203
91770078|NCT04612725|183427269|SUPERIORITY||LS mean difference|-2.6||||0.0754|TWO_SIDED|95.0|-5.46|0.27||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.27|-5.46|0.0754
91770079|NCT04612725|183427269|SUPERIORITY||LS mean difference|-1.06||||0.4772|TWO_SIDED|95.0|-4.01|1.89||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.89|-4.01|0.4772
91770080|NCT04612725|183427269|SUPERIORITY||LS mean difference|-2.0||||0.1851|TWO_SIDED|95.0|-4.96|0.97||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.97|-4.96|0.1851
91770081|NCT04612725|183427271|SUPERIORITY|||||||0.9678||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.9678
91770082|NCT04612725|183427271|SUPERIORITY|||||||0.3689||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.3689
91770083|NCT04612725|183427271|SUPERIORITY||percentage difference|-3.43||||0.6624|TWO_SIDED|95.0|-18.96|12.11||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||12.11|-18.96|0.6624
91770084|NCT04612725|183427271|SUPERIORITY||percentage difference|0.28||||0.9726|TWO_SIDED|95.0|-15.84|16.4||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||16.40|-15.84|0.9726
91770085|NCT04612725|183427273|SUPERIORITY||LS mean difference|-0.29||||0.7256|TWO_SIDED|95.0|-1.9|1.32||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.32|-1.90|0.7256
91518582|NCT02157779|182911460|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.246|TWO_SIDED|95.0|-0.283|0.073||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.||0.073|-0.283|0.246
91770086|NCT04612725|183427273|SUPERIORITY||LS mean difference|1.09||||0.189|TWO_SIDED|95.0|-0.54|2.72||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.72|-0.54|0.1890
91770087|NCT04612725|183427273|SUPERIORITY||LS mean difference|-0.63||||0.5048|TWO_SIDED|95.0|-2.51|1.24||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.24|-2.51|0.5048
91706153|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.291||0.0377|TWO_SIDED|90.0|-1.09|-0.13|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.13|-1.09|0.0377
91770088|NCT04612725|183427273|SUPERIORITY||LS mean difference|0.99||||0.2991|TWO_SIDED|95.0|-0.89|2.88||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.88|-0.89|0.2991
91770089|NCT04612725|183427274|SUPERIORITY||LS mean difference|1.63||||0.5704|TWO_SIDED|95.0|-4.05|7.32||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||7.32|-4.05|0.5704
91770090|NCT04612725|183427274|SUPERIORITY||LS mean difference|-2.24||||0.4416|TWO_SIDED|95.0|-7.98|3.5||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.50|-7.98|0.4416
91770091|NCT04612725|183427274|SUPERIORITY||LS mean difference|1.47||||0.6591|TWO_SIDED|95.0|-5.09|8.02||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||8.02|-5.09|0.6591
91770092|NCT04612725|183427274|SUPERIORITY||LS mean difference|-3.04||||0.3624|TWO_SIDED|95.0|-9.62|3.54||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.54|-9.62|0.3624
91770093|NCT04612725|183427275|SUPERIORITY||LS mean difference|0.48||||0.7037|TWO_SIDED|95.0|-2.02|2.98||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.98|-2.02|0.7037
91770094|NCT04612725|183427275|SUPERIORITY||LS mean difference|-1.25||||0.332|TWO_SIDED|95.0|-3.78|1.29||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.29|-3.78|0.3320
91770095|NCT04612725|183427275|SUPERIORITY||LS mean difference|1.24||||0.359|TWO_SIDED|95.0|-1.42|3.9||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.90|-1.42|0.3590
91770096|NCT04612725|183427275|SUPERIORITY||LS mean difference|-0.88||||0.5175|TWO_SIDED|95.0|-3.56|1.8||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.80|-3.56|0.5175
91770097|NCT03863509|183427278|OTHER|||||||0.494|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 384) = 0.707, p = .494||||||.494
91770098|NCT03863509|183427279|OTHER|||||||0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference F(2, 381) = 7.409, p = .001||||||0.001
91770099|NCT03863509|183427279|OTHER||Mean Difference (Final Values)|-0.42||||0.822|TWO_SIDED|95.0|-4.08|3.24|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried.||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||3.240|-4.080|0.822
91770100|NCT03863509|183427279|OTHER||Mean Difference (Final Values)|7.267||||0.001|TWO_SIDED|95.0|2.974|11.559|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.559|2.974|0.001
91770101|NCT03863509|183427279|OTHER||Mean Difference (Final Values)|7.687|||<|0.001|TWO_SIDED|95.0|3.485|11.889|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||These are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.889|3.485|<0.001
91770102|NCT03863509|183427280|OTHER|||||||0.074||||||Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 2.616, p = .074|ANCOVA|||||||.074
91770103|NCT03863509|183427281|OTHER||Type III F-test of Fixed Group x Time ef|6.609||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Omnibus Group x Time (pre-post) interaction test: F (2, 378.467) = 6.609, p = .002. Age, race, and sex were covaried.|F (2, 378.467) = 6.609, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.002
91770104|NCT03863509|183427281|OTHER||interaction estimate|3.3|STANDARD_ERROR_OF_MEAN|0.99||0.001|TWO_SIDED|95.0|1.36|5.24|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||5.24|1.36|0.001
91770105|NCT03863509|183427281|OTHER||interaction term estimate|3.29|STANDARD_ERROR_OF_MEAN|1.06||0.002|TWO_SIDED|95.0|1.2|5.38|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive cigarette smokers x Time vs never users x time as reference|||5.38|1.20|0.002
91770106|NCT03863509|183427281|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.948||0.992|TWO_SIDED||||||ANCOVA|||||||.992
91770107|NCT03863509|183427282|OTHER||Type III F-test of Fixed Group x Time ef|5.843||||0.003|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 378.999) = 5.843, p = .003|F (2, 378.999) = 5.843, p = .003|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.003
91581303|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.561|STANDARD_ERROR_OF_MEAN|0.38||0.141||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.141
91706154|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.28||0.0001|TWO_SIDED|90.0|-1.57|-0.65|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.65|-1.57|0.0001
91706155|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.284||0.8612|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8612
91706156|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.292||0.133|TWO_SIDED|90.0|-0.04|0.93|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.93|-0.04|0.1330
91706157|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.285||0.8542|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8542
91770108|NCT03863509|183427282|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.002|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.002
91706158|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.288||0.2339|TWO_SIDED|90.0|-0.13|0.82|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.82|-0.13|0.2339
91706159|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5927|TWO_SIDED|90.0|-0.61|0.31|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.61|0.5927
91706160|NCT00938587|183306675|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.284||0.7304|TWO_SIDED|90.0|-0.57|0.37|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.57|0.7304
91770109|NCT03863509|183427282|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.003|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive Smokers x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.003
91770110|NCT03863509|183427282|OTHER||Interaction term Coefficient|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.917|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||||.917
91770111|NCT03863509|183427283|OTHER||Type III F-test of Fixed Group x Time Ef|49.42|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 376.099) = 49.420, p \< .001|F (2, 376.099) = 49.420, p \< .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||< .001
91770112|NCT03863509|183427283|OTHER||interaction term coefficient|6.06|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.83|7.3|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||7.3|4.83|<0.001
91770113|NCT03863509|183427283|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|3.76|6.42|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||6.42|3.76|<0.001
91770114|NCT03863509|183427283|OTHER||interaction term coefficient|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.107|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.107
91770115|NCT03863509|183427284|OTHER||Type III F-test of Fixed Group x Time Ef|6.194||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,372.971) = 6.194, p = .002|F (2,372.971) = 6.194, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.002
91770116|NCT03863509|183427284|OTHER||interaction term coefficient|-0.005|STANDARD_ERROR_OF_MEAN|0.001||0.003|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.002|-0.01|0.003
91770117|NCT03863509|183427284|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.001|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.002|-0.01|0.001
91770118|NCT03863509|183427284|OTHER||interaction term coefficient|-0.001|STANDARD_ERROR_OF_MEAN|0.002||0.582|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.582
91770119|NCT03863509|183427285|OTHER||Type III F-test of Fixed Group x Time E|1.753||||0.175|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried.|FMD responses in e-cigarette users, cigarette users, and never-users controls after adjusting for changes in brachial artery diameter.|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.175
91770120|NCT03863509|183427285|OTHER||interaction term coefficient|0.75|STANDARD_ERROR_OF_MEAN|0.41||0.067|TWO_SIDED|95.0|-0.05|1.56|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||1.56|-0.05|0.067
91518583|NCT02157779|182911461|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.036|TWO_SIDED|95.0|-0.27|-0.01||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.||-0.01|-0.27|0.036
91706161|NCT00938587|183306676|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.29||0.0956|TWO_SIDED|90.0|-0.97|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-0.97|0.0956
91770121|NCT03863509|183427285|OTHER||interaction term coefficient|0.33|STANDARD_ERROR_OF_MEAN|0.44||0.464|TWO_SIDED|95.0|-0.55|1.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.20|-0.55|0.464
91790134|NCT00282464|183459375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Baseline to endpoint||||0.428
91518584|NCT02157779|182911462|SUPERIORITY||Least Squares Mean Difference|-0.026||||0.786|TWO_SIDED|95.0|-0.213|0.1614||Threshold for statistical significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.1614|-0.213|0.786
91518585|NCT02157779|182911463|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.744|TWO_SIDED|95.0|-0.18|0.13||Threshold for significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.13|-0.18|0.744
91518586|NCT02157779|182911464|SUPERIORITY||Least Squares Mean Difference|-1.85||||0.002|TWO_SIDED|95.0|-3.038|-0.663||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||-0.663|-3.038|0.002
91518587|NCT02157779|182911465|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.186|TWO_SIDED|95.0|-2.518|0.524||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||0.524|-2.518|0.186
91518588|NCT02157779|182911466|SUPERIORITY||Least Squares Mean Difference|1.26||||0.164|TWO_SIDED|95.0|-0.56|3.09||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||3.09|-0.560|0.164
91518589|NCT02157779|182911467|SUPERIORITY||Least Squares Mean Difference|1.33||||0.1|TWO_SIDED|95.0|-0.26|2.92||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||2.92|-0.26|0.100
91581304|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.088|STANDARD_ERROR_OF_MEAN|0.258||0.734||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.734
91581305|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.251||0.477||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.477
91581306|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.3|STANDARD_ERROR_OF_MEAN|0.252||0.235||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.235
91581307|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.391|STANDARD_ERROR_OF_MEAN|0.245||0.111||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.111
91581308|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.349|STANDARD_ERROR_OF_MEAN|0.343||0.31||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.310
91581309|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.568|STANDARD_ERROR_OF_MEAN|0.334||0.09||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.090
91581310|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.729|STANDARD_ERROR_OF_MEAN|0.335||0.03||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.030
91770122|NCT03863509|183427285|OTHER||interaction term coefficient|-0.43|STANDARD_ERROR_OF_MEAN|0.4||0.284|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing effects of group, time, and group x time in FMD, age, sex, race adjusted, for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.284
91770123|NCT03863509|183427286|OTHER||Type III F-test of Fixed Group x Time Ef|8.323|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 342.847) = 8.323, p = \<.001|F (2,342.847) = 8.323, p = \<.001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||<0.001
91790135|NCT00282464|183459376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status||Change from baseline to endpoint||||0.708
91581311|NCT01160289|183052322|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.948|STANDARD_ERROR_OF_MEAN|0.326||0.004||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.004
91581312|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.656||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.656
91581313|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.46||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.460
91581314|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.198
91581315|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.009
91581316|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.671||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.671
91581317|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.259||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.259
91581318|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.441
91581319|NCT01160289|183052324|SUPERIORITY_OR_OTHER|||||||0.433||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.433
91581320|NCT01160289|183052325|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.13||||0.423||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.423
91770124|NCT03863509|183427286|OTHER||interaction term coefficient|-6.55|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-9.89|-3.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-3.20|-9.89|<0.001
91581321|NCT01160289|183052325|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.12||||0.443||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.443
91770125|NCT03863509|183427286|OTHER||interaction term coefficient|-6.11|STANDARD_ERROR_OF_MEAN|1.83||0.001|TWO_SIDED|95.0|-9.71|-2.52|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-2.52|-9.71|0.001
91790136|NCT00282464|183459377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.898
91581322|NCT01160289|183052325|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.084||||0.599||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.599
91581323|NCT01160289|183052325|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.334||||0.029||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.029
91581324|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.152||||0.148||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.148
91581325|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.216||||0.033||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.033
91581326|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.124||||0.224||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.224
91581327|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.189||||0.056||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.056
91581328|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.211||||0.031||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.031
91581329|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.227||||0.017||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.017
91581330|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.016||||0.866||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.866
91581331|NCT01160289|183052326|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.032||||0.726||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.726
91770126|NCT03863509|183427286|OTHER||interaction term coefficient|0.44|STANDARD_ERROR_OF_MEAN|1.61||0.787|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.787
91770127|NCT03863509|183427287|OTHER||Type III F-test of Fixed Group x Time Ef|7.26||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 345.918) = 7.260, p = .001|F (2,345.918) = 7.260, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
91770128|NCT03863509|183427287|OTHER||interaction term coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.31|-0.08|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.08|-0.31|0.001
91770129|NCT03863509|183427287|OTHER||interaction term coefficient|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.33|-0.09|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.09|-0.33|0.001
91770130|NCT03863509|183427287|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.847|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.847
91770131|NCT03863509|183427288|OTHER||Type III F-test of Fixed Group x Time Ef|1.712||||0.182|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 312.081) = 1.712, p = .182|F (2, 312.081) = 1.712, p = .182|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.182
91770132|NCT03863509|183427288|OTHER||interaction term coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|-0.09|0.004|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||0.004|-0.09|0.07
91770133|NCT03863509|183427288|OTHER||interaction term coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.196|TWO_SIDED|95.0|-0.09|0.02|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.02|-0.09|0.196
91770134|NCT03863509|183427288|OTHER||interaction term coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.69
91770135|NCT03863509|183427289|OTHER||Type III F-test of Fixed Group x Time Ef|4.096||||0.017|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.239) = 4.096, p = .017|F (2, 373.239) = 4.096, p = .017|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.017
91770136|NCT03863509|183427289|OTHER||interaction term coefficient|-3.04|STANDARD_ERROR_OF_MEAN|1.09||0.005|TWO_SIDED|95.0|-5.18|-0.91|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-0.91|-5.18|0.005
91770137|NCT03863509|183427289|OTHER||interaction term coefficient|-1.29|STANDARD_ERROR_OF_MEAN|1.18||0.274|TWO_SIDED|95.0|-3.61|1.03|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.03|-3.61|0.274
91770138|NCT03863509|183427289|OTHER||interaction term coefficient|1.75|STANDARD_ERROR_OF_MEAN|1.06||0.098|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.098
91770139|NCT03863509|183427290|OTHER||Type III F-test of Fixed Group x Time Ef|0.26||||0.771|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.434) = 0.260, p = .771|F (2, 373.434) = 0.260, p = .771|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||.771
91770140|NCT03863509|183427290|OTHER||interaction term coefficient|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.918|TWO_SIDED|95.0|-2.35|2.12|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||2.12|-2.35|0.918
91770141|NCT03863509|183427290|OTHER||interaction term coefficient|-0.8|STANDARD_ERROR_OF_MEAN|1.23||0.518|TWO_SIDED|95.0|-3.22|1.63|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.63|-3.22|0.518
91770142|NCT03863509|183427290|OTHER||interaction term coefficient|-0.68|STANDARD_ERROR_OF_MEAN|1.11||0.539|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.539
91770143|NCT03863509|183427291|OTHER||Type III F-test of Fixed Group x Time Ef|7.157||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 375.412) = 7.157, p = .001|F (2, 375.412) = 7.157, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.001
91770144|NCT03863509|183427291|OTHER||interaction term coefficient|-3.39|STANDARD_ERROR_OF_MEAN|1.04||0.001|TWO_SIDED|95.0|-5.43|-1.35|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-1.35|-5.43|0.001
91770145|NCT03863509|183427291|OTHER||interaction term coefficient|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.778|TWO_SIDED|95.0|-2.53|1.89|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.89|-2.53|0.778
91770146|NCT03863509|183427291|OTHER||interaction term coefficient|3.08|STANDARD_ERROR_OF_MEAN|1.08||0.002|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.002
91770147|NCT03863509|183427292|OTHER||Type III F-test of Fixed Group x Time Ef|4.317||||0.014|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.170) = 4.317, p = .014|F (2, 373.170) = 4.317, p = .014|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.014
91770148|NCT03863509|183427292|OTHER||interaction term coefficient|-5.08|STANDARD_ERROR_OF_MEAN|2.1||0.016|TWO_SIDED|95.0|-9.21|-0.95|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.95|-9.21|0.016
91770149|NCT03863509|183427292|OTHER||interaction term coefficient|0.01|STANDARD_ERROR_OF_MEAN|2.28||0.998|TWO_SIDED|95.0|-4.47|4.48|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||4.48|-4.47|0.998
91770150|NCT03863509|183427292|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|2.04||0.013|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.013
91770151|NCT03863509|183427293|OTHER||Type III F-test of Fixed Group x Time Ef|6.694||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,376.779) = 6.694, p = .001|F ((2,376.779) = 6.694, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and-between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
91770152|NCT03863509|183427293|OTHER||interaction term coefficient|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|-0.14|-0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.04|-0.14|0.001
91770153|NCT03863509|183427293|OTHER||interaction term coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.555|TWO_SIDED|95.0|-0.08|0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.04|-0.08|0.555
91770154|NCT03863509|183427293|OTHER||interaction term coefficient|0.007|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.007
91770155|NCT03863509|183427294|OTHER||||||<|0.001||||||ANCOVA for group differences|ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 12.869, p \< .001||||||< .001
91770156|NCT03863509|183427294|OTHER||Mean Difference (Final Values)|1.352||||0.269|TWO_SIDED|95.0|-1.048|3.752|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||3.752|-1.048|0.269
91770157|NCT03863509|183427294|OTHER||Mean Difference (Final Values)|-5.575|||<|0.001|TWO_SIDED|95.0|-8.37|-2.78|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||-2.780|-8.37|<0.001
91770158|NCT03863509|183427294|OTHER||Mean Difference (Final Values)|-6.927|||<|0.001|TWO_SIDED|95.0|-9.672|-4.183|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried.||Exclusive E-Cig Users minus Exclusive Smokers||-4.183|-9.672|<0.001
91770159|NCT03863509|183427295|OTHER|||||||0.035|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 3.392, p = .035|||Group difference did not survive correction for false discovery rate at .05, therefore not followed with post-hoc pairwise comparisons.|||.035
91770160|NCT03863509|183427296|OTHER|||||||0.549|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 0.601, p = .549||||||.549
91706162|NCT00938587|183306676|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.286||0.0016|TWO_SIDED|90.0|-1.4|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.40|0.0016
91770161|NCT03863509|183427297|OTHER|||||||0.022|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 381) = 3.877, p = .022|||Group difference tested after correction for false discovery rate at .05, therefore we followed with post-hoc pairwise comparisons.|||.022
91770162|NCT03863509|183427297|OTHER|||||||0.952|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||||0.952
91770163|NCT03863509|183427297|OTHER|||||||0.014|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||post hoc pairwise group comparisons.. Never Users minus Exclusive Smokers||||0.014
91770164|NCT03863509|183427297|OTHER|||||||0.011||||||Age, sex, and race were covaried|ANCOVA post-hoc pairwise group compariso|||Exclusive E-Cig Users minus Exclusive Smokers||||0.011
91770165|NCT03863509|183427298|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Outcome variable log-transformed for analysis. Test for group difference: F (2, 381) = 33.442, p \< .001|||Group difference tested for false discovery rate at .05 and followed with post-hoc pairwise comparisons.|||< .001
91770166|NCT03863509|183427298|OTHER||Mean Difference (Final Values)|0.18||||0.013|TWO_SIDED|95.0|0.039|0.322|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive E-Cig Users:||0.322|0.039|0.013
91770167|NCT03863509|183427298|OTHER||Mean Difference (Final Values)|0.679|||<|0.001|TWO_SIDED|95.0|0.514|0.844|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive Smokers||0.844|0.514|<0.001
91770168|NCT03863509|183427298|OTHER||Mean Difference (Final Values)|0.498|||<|0.001|TWO_SIDED|95.0|0.336|0.66|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried|"Estimated marginal mean differences (log-transformed scale)"|Exclusive E-Cig users minus Exclusive Smokers||0.660|0.336|<0.001
91770169|NCT03863509|183427299|OTHER|||||||0.15|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 1.904, p = .150||||||.150
91770170|NCT03863509|183427300|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 385) = 17.872, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||< .001
91770171|NCT03863509|183427300|OTHER||Mean Difference (Final Values)|-3.632||||0.003|TWO_SIDED|95.0|-6.019|-1.245|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||-1.245|-6.019|0.003
91770172|NCT03863509|183427300|OTHER||Mean Difference (Final Values)|-8.38|||<|0.001|TWO_SIDED|95.0|-11.14|-5.62|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive Smokers||-5.62|-11.14|<0.001
91770173|NCT03863509|183427300|OTHER||Mean Difference (Final Values)|-4.748||||0.001|TWO_SIDED|95.0|-7.456|-2.04|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||-2.040|-7.456|0.001
91770174|NCT03863509|183427301|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||< .001
91770175|NCT03863509|183427301|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
91770176|NCT03863509|183427301|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
91770177|NCT03863509|183427301|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
91770178|NCT03863509|183427302|OTHER|||||||0.199|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 1.621, p = .199||||||.199
91770179|NCT03863509|183427303|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
91770180|NCT03863509|183427303|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive E-Cig users||1.824|0.733|<0.001
91770181|NCT03863509|183427303|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|age, sex, race covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
91770182|NCT03863509|183427303|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
91770183|NCT03863509|183427304|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
91770184|NCT03863509|183427304|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex, race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
91770185|NCT03863509|183427304|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
91770186|NCT03863509|183427304|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
91770187|NCT03863509|183427305|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 344) = 10.075, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||<0.001
91770188|NCT03861273|183427306|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Mean Difference (Final Values)|-3.13||||0.0081|TWO_SIDED|95.0|-5.44|-0.81|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.81|-5.44|0.0081
91770189|NCT03861273|183427307|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Median Difference (Final Values)|-2.62||||0.0019|TWO_SIDED|95.0|-4.27|-0.96|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.96|-4.27|0.0019
91770190|NCT03861273|183427308|SUPERIORITY||Mean Difference (Final Values)|-54.37|||<|0.0001|TWO_SIDED|95.0|-63.64|-45.1|||Paired t-test|||The treatment difference (PF-06838435 - FIX Prophylaxis) estimate (95% CI) and p-value were obtained from paired t-test.||-45.10|-63.64|<.0001
91770191|NCT03861273|183427309|OTHER||||||<|0.0001||||||P-value from one-sided t-statistic testing the log transformation of the steady state FIX:C \> log(5). Cumulative for 3 assays.|One-sided t-statistic testing|||Week 12 to Month 15||||<.0001
91770192|NCT03861273|183427311|SUPERIORITY||Mean Difference (Final Values)|-2935.7|||<|0.0001|TWO_SIDED|95.0|-3403.1|-2468.3|||Paired t-test|||||-2468.30|-3403.10|<.0001
91770193|NCT03861273|183427312|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-2.55||||0.0191|TWO_SIDED|95.0|-4.67|-0.42|||Generalized linear model (GLM)|||||-0.42|-4.67|0.0191
91770194|NCT03861273|183427313|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Median Difference (Final Values)|-0.57||||0.1528|TWO_SIDED|95.0|-1.35|0.21|||Generalized linear model (GLM)|||||0.21|-1.35|0.1528
91770195|NCT03861273|183427314|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-0.51||||0.3738|TWO_SIDED|95.0|-1.63|0.61|||Generalized linear model (GLM)|||||0.61|-1.63|0.3738
91770196|NCT03861273|183427317|OTHER|||||||0.0117|||||||Paired t-test|||||||0.0117
91770197|NCT03861273|183427318|OTHER|||||||0.0052|||||||Paired t-test|||||||0.0052
91770198|NCT03861273|183427319|OTHER|||||||0.0237|||||||Paired t-test|||||||0.0237
91770199|NCT03270436|183427344|SUPERIORITY|||||||0.3599||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3599
91770200|NCT03270436|183427344|SUPERIORITY|||||||0.3207||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3207
91770201|NCT03270436|183427345|SUPERIORITY|||||||0.5698||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5698
91770202|NCT03270436|183427345|SUPERIORITY|||||||0.4106||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4106
91706163|NCT00938587|183306676|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.287||0.0258|TWO_SIDED|90.0|-1.13|-0.17|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.17|-1.13|0.0258
91770203|NCT03270436|183427346|SUPERIORITY|||||||0.0293||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0293
91770204|NCT03270436|183427346|SUPERIORITY|||||||0.4686||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4686
91770205|NCT03270436|183427347|SUPERIORITY|||||||0.0068||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0068
91770206|NCT03270436|183427347|SUPERIORITY|||||||0.9181||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9181
91581332|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-9.014|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
91770207|NCT03270436|183427348|SUPERIORITY|||||||0.5984||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5984
91770208|NCT03270436|183427348|SUPERIORITY|||||||0.3376||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3376
91770209|NCT03270436|183427349|SUPERIORITY|||||||0.296||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.2960
91770210|NCT03270436|183427349|SUPERIORITY|||||||0.1519||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1519
91770211|NCT03270436|183427350|SUPERIORITY|||||||0.2824||||||The p-value above reflects results of between-arms analysis of change from baseline to immediate post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.2824
91770212|NCT03270436|183427350|SUPERIORITY|||||||0.7547||||||The p-value above reflects results of between-arms analysis of change from baseline to 6 months post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.7547
91770213|NCT03270436|183427351|SUPERIORITY|||||||0.6928||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.6928
91770214|NCT03270436|183427351|SUPERIORITY|||||||0.4947||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4947
91770215|NCT03270436|183427352|SUPERIORITY|||||||0.1539||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1539
91770216|NCT03270436|183427352|SUPERIORITY|||||||0.1878||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1878
91770217|NCT03270436|183427353|SUPERIORITY|||||||0.4322||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4322
91770218|NCT03270436|183427353|SUPERIORITY|||||||0.9529||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9529
91770219|NCT01959503|183427359|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank-Sum Test|||||||<0.0001
91581333|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.547|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
91706164|NCT00938587|183306676|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.283||0.0002|TWO_SIDED|90.0|-1.56|-0.62|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.62|-1.56|0.0002
91770220|NCT01959503|183427360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|4.07|19.89|||Regression, Logistic|||||19.89|4.07|<0.0001
91581334|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-9.216|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
91770221|NCT01959503|183427361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.69|||<|0.0001|TWO_SIDED|95.0|3.27|18.11|||Regression, Logistic|||||18.11|3.27|<0.0001
91770222|NCT02413918|183427376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_DEVIATION|20.0|<|0.0094|TWO_SIDED|||||p value is not adjusted for multiple comparisons (see above). A priori threshold for significance was p\<0.05.|t-test, 2 sided|||BISS Outcomes: Mean changes in depression and mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0094
91770223|NCT02413918|183427376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||BISS Outcomes: Mean changes in mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0001
91770224|NCT04233801|183427377|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed model repeated measures|||||-0.71|-1.28|< 0.0001
91770225|NCT04233801|183427377|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.7|||Mixed model repeated measures|||||-0.70|-1.26|< 0.0001
91770226|NCT04233801|183427378|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|2.29||||0.1375|TWO_SIDED|95.0|0.77|6.83|||Regression, Logistic|||||6.83|0.77|0.1375
91770227|NCT04233801|183427378|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|6.01||||0.0008|TWO_SIDED|95.0|2.11|17.1|||Regression, Logistic|||||17.10|2.11|0.0008
91770228|NCT04233801|183427379|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.34|||Mixed model repeated measures|||||-1.34|-2.66|< 0.0001
91770229|NCT04233801|183427379|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.96|-0.67|||Mixed model repeated measures|||||-0.67|-1.96|< 0.0001
91770230|NCT04233801|183427380|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-3.6||||0.0774|TWO_SIDED|95.0|-7.61|0.4|||Mixed model repeated measures|||||0.40|-7.61|0.0774
91770231|NCT04233801|183427380|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.01||||0.616|TWO_SIDED|95.0|-4.98|2.96|||Mixed model repeated measures|||||2.96|-4.98|0.6160
91770232|NCT04233801|183427381|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.78||||0.1222|TWO_SIDED|95.0|-4.05|0.48|||Mixed model repeated measures|||||0.48|-4.05|0.1222
91770233|NCT04233801|183427381|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|0.65||||0.5687|TWO_SIDED|95.0|-1.59|2.89|||Mixed model repeated measures|||||2.89|-1.59|0.5687
91770234|NCT04233801|183427382|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-20.05||||0.0003|TWO_SIDED|95.0|-30.73|-9.38|||Mixed model repeated measures|||||-9.38|-30.73|0.0003
91770235|NCT04233801|183427382|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-24.13|||<|0.0001|TWO_SIDED|95.0|-34.72|-13.54|||Mixed model repeated measures|||||-13.54|-34.72|<0.0001
91524190|NCT01216163|182923479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.02|TWO_SIDED|95.0|0.05|0.45||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic.||0.45|0.05|0.020
91770236|NCT04233801|183427383|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-56.32|||<|0.0001|TWO_SIDED|95.0|-78.22|-34.41|||ANCOVA|||||-34.41|-78.22|<0.0001
91770237|NCT04233801|183427383|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-60.71|||<|0.0001|TWO_SIDED|95.0|-82.31|-39.11|||ANCOVA|||||-39.11|-82.31|<0.0001
91770238|NCT04233801|183427384|OTHER||Odds Ratio (OR)|1.76||||0.2422|TWO_SIDED|95.0|0.68|4.55|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||4.55|0.68|0.2422
91770239|NCT04233801|183427384|OTHER||Odds Ratio (OR)|0.85||||0.7661|TWO_SIDED|95.0|0.29|2.5|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||2.50|0.29|0.7661
91770240|NCT01841281|183427408|OTHER|||||||0.78||||||The p-value is for the interaction term|testing for interaction term|||||||0.78
91790137|NCT00282464|183459378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.559
91770241|NCT01841281|183427409|OTHER|||||||0.09||||||The p-value is for the interaction term|testing for interaction term|||The treatment effect was tested as an interaction term between treatment and FeNO. The null hypothesis is the effect of treatment is stratified by the FeNO status. We used a regression model instead of t-test or Wilcoxon signed-rank test in order to control period and carry-over effect which is common in a cross-over study design||||0.09
91770242|NCT00683878|183427410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1175||0.0007|TWO_SIDED|95.0|-0.63|-0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.17|-0.63|0.0007
91770243|NCT00683878|183427410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.1175|<|0.0001|TWO_SIDED|95.0|-0.78|-0.31||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.31|-0.78|<0.0001
91770244|NCT00683878|183427411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.0|STANDARD_ERROR_OF_MEAN|9.007|<|0.0001|TWO_SIDED|95.0|-68.7|-33.2||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-33.2|-68.7|<0.0001
91770245|NCT00683878|183427411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.3|STANDARD_ERROR_OF_MEAN|9.039|<|0.0001|TWO_SIDED|95.0|-71.1|-35.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-35.6|-71.1|<0.0001
91770246|NCT00683878|183427412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.32|-0.79||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.79|-2.32|<0.0001
91770247|NCT00683878|183427412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.55|-1.02||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.02|-2.55|<0.0001
91770248|NCT00683878|183427413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|4.088|<|0.0001|TWO_SIDED|95.0|-27.5|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-11.4|-27.5|<0.0001
91770249|NCT00683878|183427413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|4.082|<|0.0001|TWO_SIDED|95.0|-32.2|-16.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-16.1|-32.2|<0.0001
91770250|NCT00683878|183427414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|5.119||0.0496|TWO_SIDED|95.0|0.0|20.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||20.1|0.0|0.0496
91770251|NCT00683878|183427414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.253||0.0018|TWO_SIDED|95.0|6.1|26.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||26.7|6.1|0.0018
91770252|NCT00683878|183427415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.6006||0.1566|TWO_SIDED|95.0|-2.03|0.33||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||0.33|-2.03|0.1566
91770253|NCT00683878|183427415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.5995||0.0101|TWO_SIDED|95.0|-2.73|-0.37||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.37|-2.73|0.0101
91706165|NCT00938587|183306676|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.284||0.5692||90.0|-0.63|0.31|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.63|0.5692
91770254|NCT00683878|183427416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.4838|||TWO_SIDED|95.0|-2.53|-0.62||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. The comparison was stopped due to the preceding test (PLACEBO + Pio vs Dapa 5MG + Pio) not statistically significant P value = 0.1566.|ANCOVA|||||-0.62|-2.53|
91770255|NCT00683878|183427416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4688|<|0.0001|TWO_SIDED|95.0|-2.83|-0.98||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.98|-2.83|<0.0001
91770256|NCT04024891|183427417|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.7|||Mixed Models Analysis|||||-0.7|-1.3|<0.0001
91770257|NCT00308139|183427467|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.107||0.0023|TWO_SIDED|95.0|-0.54|-0.12|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.||-0.12|-0.54|0.0023
91770258|NCT00308139|183427470|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.0003
91770259|NCT00308139|183427472|SUPERIORITY_OR_OTHER|||||||0.2042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target value of \<=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.2042
91790138|NCT00282464|183459379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458||||||For all secondary efficacy analyses, no multiple adjustments were made|ANOVA|ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.458
91770260|NCT00308139|183427474|SUPERIORITY_OR_OTHER|||||||0.1513|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.1513
91770261|NCT00308139|183427476|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|30.08|STANDARD_ERROR_OF_MEAN|11.458||0.0124|TWO_SIDED|95.0|6.88|53.28|||ANCOVA|||Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.||53.28|6.88|0.0124
91770262|NCT00308139|183427478|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.612||0.8916|TWO_SIDED|95.0|-1.29|1.12|||ANCOVA|||Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||1.12|-1.29|0.8916
91770263|NCT00308139|183427480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-24.4|-9.4|||ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.4|-24.4|<.0001
91770264|NCT00308139|183427484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|3.04||0.0077|TWO_SIDED|95.0|-14.1|-2.2|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-2.2|-14.1|0.0077
91770265|NCT00308139|183427486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.74||0.5613|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||1.9|-1.0|0.5613
91770266|NCT00308139|183427489|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.042||0.2915|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2915
91770267|NCT04231669|183427521|SUPERIORITY|||||||0.05|||||||Linear Mixed-effects regression|||||||0.05
91770268|NCT00435409|183427536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2239||||0.9409|TWO_SIDED|95.0|0.9487|1.5789||Stratification factors included metastatic organ sites (2 or less versus \[vs\] more than \[\>\] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs \>1), from interactive voice response system (IVRS).|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.5789|0.9487|0.9409
91770269|NCT00435409|183427536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1084||||0.812|TWO_SIDED|95.0|0.8817|1.3935||Stratification factors include metastatic organ sites (2 or less versus \[vs\] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.3935|0.8817|0.8120
91770270|NCT00435409|183427537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3143|TWO_SIDED|95.0|0.69|1.97||A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.|Cochran-Mantel-Haenszel|||Independent radiology assessment||1.97|0.69|0.3143
91581335|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.75|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
91581336|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.977||||0.776||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
91581337|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.78||||0.814||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.814
91706166|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.146|TWO_SIDED|90.0|-8.65|35.98|||Barnard exact test|||Day 7||35.98|-8.65|0.1460
91581338|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.629||||0.627||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.627
91581339|NCT01160289|183052327|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.128||||0.968||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.968
91581340|NCT01160289|183052328|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.006||||0.984||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.984
91770271|NCT00435409|183427537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.1269|TWO_SIDED|95.0|0.83|2.13||A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.|Cochran-Mantel-Haenszel|||Investigator's assessment||2.13|0.83|0.1269
91770272|NCT00435409|183427539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0372||||0.6275|TWO_SIDED|95.0|0.8322|1.2927||Stratification factors (all from IVRS) included number of metastatic organ sites (\<=2 vs \>2 sites), hormone receptor status (HER2-/ER-/PR- vs all others), and prior chemotherapy regimens (1 vs \>1).|Log Rank||Hazard ratio for sunitinib + capecitabine versus capecitabine.|||1.2927|0.8322|0.6275
91770273|NCT03192176|183427569|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.56|-0.25||LS Means(LSM), standard errors(SE), confidence intervals(CI), \& p-values come from an ANCOVA model with CFB as the dependent variable \& treatment group, pooled center, smoking status as factors \& baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.25|-3.56|0.0240
91770274|NCT03192176|183427569|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.68|-1.38||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.38|-4.68|0.0004
91770275|NCT03192176|183427569|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.001|TWO_SIDED|95.0|-4.44|-1.14||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.14|-4.44|0.0010
91770276|NCT03192176|183427569|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.2|-1.89||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.89|-5.20|<0.0001
91581341|NCT01160289|183052328|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.465||||0.076||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.076
91770277|NCT03192176|183427569|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.84||0.0058||95.0|-4.0|-0.68||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.68|-4.00|0.0058
91770278|NCT03192176|183427569|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-4.65|-1.41||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.41|-4.65|0.0003
91770279|NCT03192176|183427569|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0042|TWO_SIDED|95.0|-4.06|0.76||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.76|-4.06|0.0042
91770280|NCT03192176|183427570|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0154|TWO_SIDED|95.0|-3.3|-0.35||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.35|-3.30|0.0154
91770281|NCT03192176|183427570|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.74||0.0043|TWO_SIDED|95.0|-3.6|-0.67||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.67|-3.60|0.0043
91770282|NCT03192176|183427570|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0023|TWO_SIDED|95.0|-3.76|-0.83||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.83|-3.76|0.0023
91770283|NCT03192176|183427570|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0005|TWO_SIDED|95.0|-4.09|-1.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.16|-4.09|0.0005
91770284|NCT03192176|183427570|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0064|TWO_SIDED|95.0|-3.52|-0.58||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.58|-3.52|0.0064
91581342|NCT01160289|183052328|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.387||||0.142||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.142
91770285|NCT03192176|183427570|SUPERIORITY||-2.6|-2.6|STANDARD_ERROR_OF_MEAN|0.74||0.0005|TWO_SIDED|95.0|-4.04|-1.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.15|-4.04|0.0005
91581343|NCT01160289|183052328|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.072||||0.776||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
91581344|NCT01160289|183052329|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|5.031||||0.103||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.103
91581345|NCT01160289|183052329|SUPERIORITY_OR_OTHER||LS mean treatment difference|-3.225||||0.277||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.277
91581346|NCT01160289|183052329|SUPERIORITY_OR_OTHER||LS mean of treatment difference|7.056||||0.019||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.019
91770286|NCT03192176|183427570|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0063|TWO_SIDED|95.0|-3.52|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-3.52|0.0063
91770287|NCT03192176|183427571|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0215|TWO_SIDED|95.0|-0.84|-0.07||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.07|-0.84|0.0215
91770288|NCT03192176|183427571|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0017|TWO_SIDED|95.0|-1.01|-0.24||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.24|-1.01|0.0017
91770289|NCT03192176|183427571|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.21|-0.44||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.44|-1.21|<0.0001
91770290|NCT03192176|183427571|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.37|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-1.37|<0.0001
91770291|NCT03192176|183427571|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0322|TWO_SIDED|95.0|-0.81|-0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.04|-0.81|0.0322
91770292|NCT03192176|183427571|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0017|TWO_SIDED|95.0|-0.99|-0.23||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.23|-0.99|0.0017
91770293|NCT03192176|183427571|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.08|-0.31||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.31|-1.08|0.0004
91770294|NCT03192176|183427572|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2324|TWO_SIDED|95.0|-0.67|-0.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.16|-0.67|0.2324
91770295|NCT03192176|183427572|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0736|TWO_SIDED|95.0|-0.8|0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.04|-0.80|0.0736
91770296|NCT03192176|183427572|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.008|TWO_SIDED|95.0|-0.98|-0.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.15|-0.98|0.0080
91770297|NCT03192176|183427572|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0028|TWO_SIDED|95.0|-1.07|-0.22||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.22|-1.07|0.0028
91770298|NCT03192176|183427572|SUPERIORITY||LSMean differnce|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4647|TWO_SIDED|95.0|-0.58|0.26||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.26|-0.58|0.4647
91770299|NCT03192176|183427572|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.92|-0.1||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.10|-0.92|0.0160
91770300|NCT03192176|183427572|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0901|TWO_SIDED|95.0|-0.78|0.06||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.06|-0.78|0.0901
91770301|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0865|TWO_SIDED|95.0|-2.92|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||0.20|-2.92|0.0865
91706167|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|38.1||||0.0052|TWO_SIDED|90.0|12.25|59.46|||Barnard exact test|||Day 7||59.46|12.25|0.0052
91770302|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0009|TWO_SIDED|95.0|-4.22|-1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.10|-4.22|0.0009
91706168|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.3||||0.5094|TWO_SIDED|90.0|-22.0|24.66|||Barnard exact test|||Day 7||24.66|-22.00|0.5094
91770303|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|1e-05|TWO_SIDED|95.0|-5.06|-1.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.94|-5.06|<0.00001
91770304|NCT03192176|183427573|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|1e-05|TWO_SIDED|95.0|-5.63|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.47|-5.63|<0.00001
91770305|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.236|TWO_SIDED|95.0|-2.55|0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.63|-2.55|0.2360
91770306|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|-2.4||0.0032|TWO_SIDED|95.0|-3.92|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.80|-3.92|0.0032
91770307|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0006|TWO_SIDED|95.0|-4.29|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.19|-4.29|0.0006
91770308|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1318|TWO_SIDED|95.0|-2.86|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.38|-2.86|0.1318
91770309|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.83||0.0014|TWO_SIDED|95.0|-4.3|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.04|-4.30|0.0014
91770310|NCT03192176|183427573|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED|95.0|-4.82|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.58|-4.82|0.0001
91770311|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.3|-2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.00|-5.30|<0.0001
91770312|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.84||0.0752|TWO_SIDED|95.0|-3.15|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.15|-3.15|0.0752
91770313|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0343|TWO_SIDED|95.0|-3.38|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-3.38|0.0343
91770314|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.0049|TWO_SIDED|95.0|-3.95|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.71|-3.95|0.0049
91770315|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.84||0.0285|TWO_SIDED|95.0|-3.5|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.20|-3.50|0.0285
91770316|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.85||0.0004|TWO_SIDED|95.0|-4.69|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.37|-4.69|0.0004
91770317|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.14|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-5.14|<0.0001
91770318|NCT03192176|183427573|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-5.65|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRm|||Week 3||-2.28|-5.65|<0.0001
91518590|NCT02157779|182911468|SUPERIORITY||Least Squares Mean Difference|-6.29||||0.06|TWO_SIDED|95.0|-12.85|0.27||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.||"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI, indicating less symptomatic distress.|0.27|-12.85|0.060
91770319|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.86||0.0169|TWO_SIDED|95.0|-3.74|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.37|-3.74|0.0169
91770320|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0049|TWO_SIDED|95.0|-4.04|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.73|-4.04|0.0049
91770321|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.48|-1.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.18|-4.48|0.0008
91770322|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.84||0.0428|TWO_SIDED|95.0|-3.36|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-3.36|0.0428
91770323|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.65|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.34|-4.65|0.0004
91770324|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|-0.84||1e-05|TWO_SIDED|95.0|-4.88|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.58|-4.88|0.00001
91770325|NCT03192176|183427573|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.73|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.37|-5.73|<0.0001
91770326|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0225|TWO_SIDED|95.0|-3.64|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.28|-3.64|0.0225
91770327|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.49|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.19|-4.49|0.0008
91770328|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.42|-4.70|0.0003
91581347|NCT01160289|183052329|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.201||||0.676||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.676
91770329|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1168|TWO_SIDED|95.0|-2.8|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.31|-2.80|0.1168
91770330|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0012|TWO_SIDED|95.0|-4.15|-1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.03|-4.15|0.0012
91770331|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.54|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.42|-4.54|0.0002
91581348|NCT00768079|183052338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
91706169|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.11||||0.0551|TWO_SIDED|90.0|-0.69|48.34|||Barnard exact test|||Day 7||48.34|-0.69|0.0551
91770332|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.44|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.28|-5.44|<0.0001
91770333|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0134|TWO_SIDED|95.0|-3.58|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.42|-3.58|0.0134
91581349|NCT00768079|183052338|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
91581350|NCT00768079|183052338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
91581351|NCT00768079|183052338|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
91706170|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.99||||0.9999|TWO_SIDED|90.0|-34.09|8.78|||Barnard exact test|||Day 7||8.78|-34.09|0.9999
91770334|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.76|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-3.76|0.0057
91770335|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0016|TWO_SIDED|95.0|-4.06|-0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.96|-4.06|0.0016
91770336|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0843|TWO_SIDED|95.0|-2.94|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.19|-2.94|0.0843
91770337|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.9|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.77|-3.90|0.0035
91770338|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.52|-4.66|0.0001
91770339|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.28|-2.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.10|-5.28|<0.0001
91770340|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0315|TWO_SIDED|95.0|-3.33|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.16|-3.33|0.0315
91770341|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0063|TWO_SIDED|95.0|-3.75|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.75|0.0063
91770342|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0007|TWO_SIDED|95.0|-4.25|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.25|0.0007
91770343|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81||0.109|TWO_SIDED|95.0|-2.89|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.29|-2.89|0.1090
91770344|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0018|TWO_SIDED|95.0|-4.14|-0.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.95|-4.14|0.0018
91770345|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0004|TWO_SIDED|95.0|-4.54|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.34|-4.54|0.0004
91581352|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
91770346|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.4|-2.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.15|-5.40|<0.0001
91770347|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.82||0.0231|TWO_SIDED|95.0|-3.5|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-3.50|0.0231
91770348|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.81||0.0056|TWO_SIDED|95.0|-3.86|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.67|-3.86|0.0056
91706171|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.56||||0.3027|TWO_SIDED|90.0|-17.18|37.67|||Barnard-Exact test|||Day 14||37.67|-17.18|0.3027
91581353|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
91581354|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
91581355|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
91770349|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.81||0.0007|TWO_SIDED|95.0|-4.35|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.17|-4.35|0.0007
91770350|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.3568|TWO_SIDED|95.0|-2.35|0.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.85|-2.35|0.3568
91770351|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0129|TWO_SIDED|95.0|-3.65|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-3.65|0.0129
91770352|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0018|TWO_SIDED|95.0|-4.19|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.97|-4.19|0.0018
91770353|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.83||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.42|-4.70|0.0003
91770354|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.83||0.1004|TWO_SIDED|95.0|-3.0|0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.27|-3.00|0.1004
91770355|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0173|TWO_SIDED|95.0|-3.57|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.35|-3.57|0.0173
91770356|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.0038|TWO_SIDED|95.0|-3.97|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.77|-3.97|0.0038
91770357|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.1767|TWO_SIDED|95.0|-2.57|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.48|-2.57|0.1767
91770358|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.77||0.0308|TWO_SIDED|95.0|-3.2|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.16|-3.20|0.0308
91770359|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0013|TWO_SIDED|95.0|-4.07|-1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.00|-4.07|0.0013
91770360|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.47|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.36|-4.47|0.0003
91770361|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.79||0.2109|TWO_SIDED|95.0|-2.55|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.56|-2.55|0.2109
91518591|NCT02157779|182911469|SUPERIORITY||Least Squares Mean Difference|-3.271||||0.023|TWO_SIDED|95.0|-6.083|-0.458||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||-0.458|-6.083|0.023
91770362|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0152|TWO_SIDED|95.0|-3.44|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.37|-3.44|0.0152
91770363|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.77||0.0075|TWO_SIDED|95.0|-3.61|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.56|-3.61|0.0075
91770364|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0869|TWO_SIDED|95.0|-2.96|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.20|-2.96|0.0869
91706172|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.67||||0.1074|TWO_SIDED|90.0|-6.24|46.16|||Barnard-Exact test|||Day 14||46.16|-6.24|0.1074
91770365|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.052|TWO_SIDED|95.0|-3.14|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.01|-3.14|0.0520
91770366|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.81||0.0009|TWO_SIDED|95.0|-4.3|-1.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.12|-4.30|0.0009
91770367|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.82||0.0002|TWO_SIDED|95.0|-4.68|-1.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.46|-4.68|0.0002
91770368|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.82||0.0456|TWO_SIDED|95.0|-3.25|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-0.03|-3.25|0.0456
91770369|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.0073|TWO_SIDED|95.0|-3.76|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.59|-3.76|0.0073
91770370|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0026|TWO_SIDED|95.0|-4.01|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.86|-4.01|0.0026
91770371|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.78||0.0878|TWO_SIDED|95.0|-2.87|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.20|-2.87|0.0878
91770372|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0182|TWO_SIDED|95.0|-3.39|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.32|-3.39|0.0182
91770373|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.55|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.44|-4.55|0.0002
91770374|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8||0.0002|TWO_SIDED|95.0|-4.53|-1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.40|-4.53|0.0002
91770375|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.0387|TWO_SIDED|95.0|-3.22|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.09|-3.22|0.0387
91770376|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.79||0.0031|TWO_SIDED|95.0|-3.89|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.80|-3.89|0.0031
91770377|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.0029|TWO_SIDED|95.0|-3.88|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.81|-3.88|0.0029
91770378|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.76||0.0653|TWO_SIDED|95.0|-2.9|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.09|-2.90|0.0653
91518592|NCT02157779|182911470|SUPERIORITY||Least Squares Mean Difference|-1.28||||0.23|TWO_SIDED|95.0|-3.39|0.82||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||0.82|-3.39|0.23
91770379|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.76||0.0102|TWO_SIDED|95.0|-3.46|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.47|-3.46|0.0102
91770380|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.77||0.0002|TWO_SIDED|95.0|-4.38|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.36|-4.38|0.0002
91770381|NCT03192176|183427573|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.72|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.67|-4.72|<0.0001
91770382|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0231|TWO_SIDED|95.0|-3.3|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.25|-3.30|0.0231
91770383|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
91770384|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.76||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
91770385|NCT03192176|183427573|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.76||0.0013|TWO_SIDED|95.0|-3.96|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.97|-3.96|0.0013
91770386|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84||0.146|TWO_SIDED|95.0|-2.89|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.43|-2.89|0.1460
91770387|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.84||0.6066|TWO_SIDED|95.0|-2.1|1.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.23|-2.10|0.6066
91770388|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.87||0.8422|TWO_SIDED|95.0|-1.88|1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.54|-1.88|0.8422
91770389|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.87||0.2346|TWO_SIDED|95.0|-2.74|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.67|-2.74|0.2346
91770390|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.1128|TWO_SIDED|95.0|-3.11|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.33|-3.11|0.1128
91770391|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1811|TWO_SIDED|95.0|-2.89|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.55|-2.89|0.1811
91770392|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3521|TWO_SIDED|95.0|-2.45|0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.87|-2.45|0.3521
91770393|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.357|TWO_SIDED|95.0|-2.44|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.44|0.3570
91770394|NCT03192176|183427573|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.84||0.9227|TWO_SIDED|95.0|-1.73|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.57|-1.73|0.9227
91770395|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8894|TWO_SIDED|95.0|-1.84|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.60|-1.84|0.8894
91770396|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.5074|TWO_SIDED|95.0|-2.29|1.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.13|-2.29|0.5074
91770397|NCT03192176|183427573|SUPERIORITY||LSMean differencce|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1753|TWO_SIDED|95.0|-2.91|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.53|-2.91|0.1753
91581356|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
91770398|NCT03192176|183427573|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.88||0.1212|TWO_SIDED|95.0|-3.09|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.36|-3.09|0.1212
91770399|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3702|TWO_SIDED|95.0|-2.41|0.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.90|-2.41|0.3702
91770400|NCT03192176|183427573|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.6459|TWO_SIDED|95.0|-1.22|1.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.96|-1.22|0.6459
91770401|NCT03192176|183427573|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.8248|TWO_SIDED|95.0|-1.4|1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.75|-1.40|0.8248
91770402|NCT03192176|183427573|SUPERIORITY||LSMean difference|0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4226|TWO_SIDED|95.0|-0.98|2.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.33|-0.98|0.4226
91770403|NCT03192176|183427573|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.6469|TWO_SIDED|95.0|-1.25|2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.01|-1.25|0.6469
91770404|NCT03192176|183427573|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.84||0.7642|TWO_SIDED|95.0|-1.41|1.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.91|-1.41|0.7642
91770405|NCT03192176|183427573|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4068|TWO_SIDED|95.0|-2.36|0.966||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.966|-2.36|0.4068
91770406|NCT03192176|183427573|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7974|TWO_SIDED|95.0|-1.37|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.37|0.7974
91770407|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.78||0.0297|TWO_SIDED|95.0|-3.23|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.17|-3.23|0.0297
91770408|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.66|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.58|-4.66|<0.0001
91770409|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.78|<|1e-05|TWO_SIDED|95.0|-5.1|-2.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.02|-5.10|<0.00001
91770410|NCT03192176|183427574|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.78|-2.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.66|-5.78|<0.0001
91581357|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
91770411|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1318|TWO_SIDED|95.0|-2.76|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.36|-2.76|0.1318
91770412|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.13|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.05|-4.13|0.0010
91770413|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.0011|TWO_SIDED|95.0|-4.1|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.04|-4.10|0.0011
91581358|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
91581359|NCT00768079|183052340|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
91770414|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.79||0.0405|TWO_SIDED|95.0|-3.2|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.07|-3.20|0.0405
91770415|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.7|-1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.55|-4.70|0.0001
91770416|NCT03192176|183427574|SUPERIORITY||LSMean differencce|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.52|-4.66|0.0001
91770417|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.26|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.07|-5.26|<0.0001
91770418|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0325|TWO_SIDED|95.0|-3.34|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.15|-3.34|0.0325
91770419|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.92|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.78|-3.92|0.0035
91770420|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0102|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.49|-3.61|0.0102
91770421|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.81||0.0098|TWO_SIDED|95.0|-3.69|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.51|-3.69|0.0098
91770422|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.18|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.98|-5.18|<0.0001
91770423|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.89|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.70|-4.89|<0.0001
91518593|NCT02548455|182911471|EQUIVALENCE|Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).|Kaplan-Meier Estimate|85.0||||0.05|TWO_SIDED||||||Log Rank|||"The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) \> 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects."||||0.05
91770424|NCT03192176|183427574|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.61|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.37|-5.61|<0.0001
91770425|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0021|TWO_SIDED|95.0|-4.17|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.17|0.0021
91770426|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.81||0.0001|TWO_SIDED|95.0|-4.71|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.52|-4.71|0.0001
91770427|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.002|TWO_SIDED|95.0|-4.11|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.11|0.0020
91770428|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.021|TWO_SIDED|95.0|-3.27|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.27|-3.27|0.0210
91790139|NCT02239120|183459399|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1028|TWO_SIDED|95.0|0.69|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.69|0.1028
91770429|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-4.59|<0.0001
91770430|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.88|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.34|-1.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.33|-4.34|0.0003
91770431|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.29|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.23|-5.29|<0.0001
91770432|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.77||0.0023|TWO_SIDED|95.0|-3.91|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.86|-3.91|0.0023
91770433|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.76||0.0004|TWO_SIDED|95.0|-4.25|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.24|-4.25|0.0004
91770434|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0036|TWO_SIDED|95.0|-3.73|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.74|-3.73|0.0036
91770435|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.77||0.0195|TWO_SIDED|95.0|-3.33|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.29|-3.33|0.0195
91770436|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.21|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.17|-4.21|0.0006
91770437|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0004|TWO_SIDED|95.0|-4.32|-1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.27|-4.32|0.0004
91770438|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.01|-1.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.92|-5.01|<0.0001
91770439|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0061|TWO_SIDED|95.0|-3.71|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.71|0.0061
91770440|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.19|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.19|0.0006
91770441|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.77||0.003|TWO_SIDED|95.0|-3.81|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.78|-3.81|0.0030
91770442|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0383|TWO_SIDED|95.0|-3.17|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.09|-3.17|0.0383
91770443|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.79||0.0004|TWO_SIDED|95.0|-4.33|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.24|-4.33|0.0004
91770444|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0011|TWO_SIDED|95.0|-4.14|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.04|-4.14|0.0011
91770445|NCT03192176|183427574|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.07|-1.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.93|-5.07|<0.0001
91790140|NCT02239120|183459400|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1076|TWO_SIDED|95.0|0.94|1.97|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.97|0.94|0.1076
91770446|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0055|TWO_SIDED|95.0|-3.8|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.66|-3.80|0.0055
91770447|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0014|TWO_SIDED|95.0|-4.09|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-4.09|0.0014
91770448|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.004|TWO_SIDED|95.0|-3.8|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.73|-3.80|0.0040
91770449|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1502|TWO_SIDED|95.0|-2.68|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.41|-2.68|0.1502
91770450|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.74|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.64|-3.74|0.0057
91770451|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
91770452|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8||0.0006|TWO_SIDED|95.0|-4.38|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.22|-4.38|0.0006
91770453|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0412|TWO_SIDED|95.0|-3.21|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.07|-3.21|0.0412
91770454|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
91770455|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0167|TWO_SIDED|95.0|-3.43|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.34|-3.43|0.0167
91581360|NCT01156792|183052357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||=|0.268|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||||0.07|-0.02|=0.268
91770456|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.75||0.0533|TWO_SIDED|95.0|-2.94|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.02|-2.94|0.0533
91770457|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0065|TWO_SIDED|95.0|-3.54|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.58|-3.54|0.0065
91770458|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.76||0.0025|TWO_SIDED|95.0|-3.8|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.82|-3.80|0.0025
91770459|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0005|TWO_SIDED|95.0|-4.22|-1.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.20|-4.22|0.0005
91770460|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.77||0.0541|TWO_SIDED|95.0|-2.99|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.03|-2.99|0.0541
91770461|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0039|TWO_SIDED|95.0|-3.69|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.71|-3.69|0.0039
91581361|NCT01156792|183052357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|||=|0.08|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||||0.09|-0.00|=0.080
91581362|NCT01156792|183052357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|||=|0.017|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||||0.10|0.01|=0.017
91790141|NCT02239120|183459401|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0892|TWO_SIDED|95.0|0.68|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.68|0.0892
91770462|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.75||0.0245|TWO_SIDED|95.0|-3.18|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.22|-3.18|0.0245
91770463|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0187|TWO_SIDED|95.0|-3.36|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.31|-3.36|0.0187
91770464|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-3.68|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.62|-3.68|0.0060
91770465|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0014|TWO_SIDED|95.0|-4.06|-0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.98|-4.06|0.0014
91770466|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.49|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.37|-4.49|0.0003
91770467|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.01|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-3.61|0.0100
91770468|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0019|TWO_SIDED|95.0|-3.98|-0.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.91|-3.98|0.0019
91770469|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0049|TWO_SIDED|95.0|-3.73|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.67|-3.73|0.0049
91770470|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0186|TWO_SIDED|95.0|-3.25|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.30|-3.25|0.0186
91770471|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0024|TWO_SIDED|95.0|-3.77|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.82|-3.77|0.0024
91770472|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.76||0.0003|TWO_SIDED|95.0|-4.28|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.30|-4.28|0.0003
91770473|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.3|-1.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.29|-4.30|0.0003
91770474|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.76||0.0058|TWO_SIDED|95.0|-3.63|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-3.63|0.0058
91770475|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0008|TWO_SIDED|95.0|-4.04|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.7|-4.04|0.0008
91770476|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.59|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.64|-3.59|0.0050
91518594|NCT00386880|182911472|SUPERIORITY_OR_OTHER|||||||0.59||||||Fisher's exact test.|Fisher Exact|||During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.||||0.59
91770477|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0205|TWO_SIDED|95.0|-3.63|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.31|-3.63|0.0205
91790142|NCT02239120|183459402|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1911|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.06|0.73|0.1911
91518595|NCT03901326|182911473|OTHER|||||||0.05|||||||Chi-squared|||Rate of ICA without obstructive CAD or intervention within 90 days||||0.05
91518596|NCT03901326|182911473|OTHER||||||<|0.001|||||||Chi-squared|||Rate of patients underwent revascularization||||<0.001
91770478|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.85||0.2818|TWO_SIDED|95.0|-2.58|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.75|-2.58|0.2818
91770479|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.87||0.3102|TWO_SIDED|95.0|-2.6|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.83|-2.60|0.3102
91770480|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.87||0.1422|TWO_SIDED|95.0|-2.99|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.43|-2.99|0.1422
91770481|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.87||0.0064|TWO_SIDED|95.0|-4.12|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.68|-4.12|0.0064
91770482|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0752|TWO_SIDED|95.0|-3.28|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.16|-3.28|0.0752
91770483|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.85||0.3632|TWO_SIDED|95.0|-2.43|0.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.89|-2.43|0.3632
91770484|NCT03192176|183427574|SUPERIORITY||LSMean differencce|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0625|TWO_SIDED|95.0|-3.32|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-3.32|0.0625
91770485|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.86||0.6613|TWO_SIDED|95.0|-2.07|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.32|-2.07|0.6613
91770486|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4209|TWO_SIDED|95.0|-2.48|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.04|-2.48|0.4209
91770487|NCT03192176|183427574|SUPERIORITY||LSMean differencce|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.3288|TWO_SIDED|95.0|-2.63|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.63|0.3288
91770488|NCT03192176|183427574|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.9||0.0202|TWO_SIDED|95.0|-3.86|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.33|-3.86|0.0202
91770489|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0682|TWO_SIDED|95.0|-3.42|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-3.42|0.0682
91581363|NCT01156792|183052357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|||=|0.002|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||||0.12|0.03|=0.002
91770490|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86||0.3912|TWO_SIDED|95.0|-2.44|0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.96|-2.44|0.3912
91518597|NCT03901326|182911474|OTHER||Hazard Ratio (HR)|0.88||||0.8|TWO_SIDED|95.0|0.59|1.3|||Regression, Cox|||||1.30|0.59|0.80
91770491|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4964|TWO_SIDED|95.0|-2.25|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.09|-2.25|0.4964
91770492|NCT03192176|183427574|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.84||0.983|TWO_SIDED|95.0|-1.64|1.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.68|-1.64|0.9830
91518598|NCT03901326|182911475|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91518599|NCT03901326|182911476|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
91518600|NCT00423176|182911490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||||95.0|-1.14|0.25|||||For days 1-29|||0.25|-1.14|
91581364|NCT01156792|183052358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.946|||=|0.751|TWO_SIDED|95.0|-4.91|6.81|||Mixed Models Analysis|||||6.81|-4.91|=0.751
91581365|NCT01156792|183052358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.771|||=|0.049|TWO_SIDED|95.0|0.03|11.51|||Mixed Models Analysis|||||11.51|0.03|=0.049
91770493|NCT03192176|183427574|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9715|TWO_SIDED|95.0|-1.71|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.71|0.9715
91770494|NCT03192176|183427574|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8715|TWO_SIDED|95.0|-1.58|1.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.86|-1.58|0.8715
91770495|NCT03192176|183427574|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.89||0.2233|TWO_SIDED|95.0|-2.83|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.66|-2.83|0.2233
91770496|NCT03192176|183427574|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.2882|TWO_SIDED|95.0|-2.69|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.80|-2.69|0.2882
91770497|NCT03192176|183427574|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.8643||95.0|-1.52|1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.80|-1.52|0.8643
91770498|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0104|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0104
91770499|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.006|TWO_SIDED|95.0|-0.56|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.09|-0.56|0.0060
91770500|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.24|-0.71|<0.0001
91581366|NCT01156792|183052358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.983|||=|0.123|TWO_SIDED|95.0|-1.35|11.32|||Mixed Models Analysis|||||11.32|-1.35|=0.123
91770501|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.85|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.38|-0.85|<0.0001
91770502|NCT03192176|183427575|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.6977|TWO_SIDED|95.0|-0.28|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.19|-0.28|0.6977
91770503|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0121|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0121
91518601|NCT00423176|182911490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82||||||95.0|-1.65|0.0|||||For follow-up days 30-43|||0.00|-1.65|
91581367|NCT01156792|183052358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14|||<|0.001|TWO_SIDED|95.0|5.93|18.35|||Mixed Models Analysis|||||18.35|5.93|<0.001
91770504|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0086|TWO_SIDED|95.0|-0.54|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.54|0.0086
91770505|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0138|TWO_SIDED|95.0|-0.66|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.08|-0.66|0.0138
91790143|NCT02239120|183459403|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0354|TWO_SIDED|95.0|0.36|0.96|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||0.96|0.36|0.0354
91518602|NCT00423176|182911491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.8||||||95.0|-0.5|18.2|||||Change from baseline to endpoint|||18.2|-0.5|
91518603|NCT00420992|182911513|SUPERIORITY_OR_OTHER|||||||0.0445||95.0||||Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.|ANCOVA|Model included treatment as factor and baseline pain score as covariate.||Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.||||0.0445
91518604|NCT03712891|182911533|OTHER|t-test||||||0.12|||||||t-test, 2 sided|||||||0.12
91581368|NCT01156792|183052359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.651|||=|0.563|TWO_SIDED|95.0|-3.97|7.27|||Mixed Models Analysis|||||7.27|-3.97|=0.563
91581369|NCT01156792|183052359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||=|0.072|TWO_SIDED|95.0|-0.47|10.67|||Mixed Models Analysis|||||10.67|-0.47|=0.072
91581370|NCT01156792|183052359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.822|||=|0.126|TWO_SIDED|95.0|-1.37|11.02|||Mixed Models Analysis|||||11.02|-1.37|=0.126
91770506|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0014|TWO_SIDED|95.0|-0.78|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.19|-0.78|0.0014
91770507|NCT03192176|183427575|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.43|-1.02|<0.0001
91770508|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.19|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-1.19|<0.0001
91770509|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2831|TWO_SIDED|95.0|-0.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.14|-0.46|0.2831
91770510|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0051|TWO_SIDED|95.0|-0.72|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-0.72|0.0051
91770511|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.81|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.22|-0.81|0.0006
91770512|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0058|TWO_SIDED|95.0|-0.83|-0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.14|-0.83|0.0058
91770513|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0004|TWO_SIDED|95.0|-0.97|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.28|-0.97|0.0004
91770514|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.46|-1.14|<0.0001
91518605|NCT01570829|182911568|SUPERIORITY|||||||0.0352|||||||Fisher Exact|||||||0.0352
91770515|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.27|-0.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.57|-1.27|<0.0001
91770516|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0807|TWO_SIDED|95.0|-0.66|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.04|-0.66|0.0807
91770517|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0014|TWO_SIDED|95.0|-0.91|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.22|-0.91|0.0014
91770518|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17||0.0001|TWO_SIDED|95.0|-1.02|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.34|-1.02|0.0001
91770519|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0046|TWO_SIDED|95.0|-0.85|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.16|-0.85|0.0046
91770520|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-0.99|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.29|-0.99|0.0003
91770521|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.45|-1.14|<0.0001
91790144|NCT02239120|183459404|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8074|TWO_SIDED|95.0|0.66|1.38|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.38|0.66|0.8074
91518606|NCT01570829|182911569|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91518607|NCT01570829|182911570|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91518608|NCT01570829|182911571|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|Breslow-Day test p-value is 0.98||||||0.0001
91770522|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.70|-1.14|<0.0001
91770523|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0209|TWO_SIDED|95.0|-0.77|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-0.77|0.0209
91770524|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_DEVIATION|0.18||0.0011|TWO_SIDED|95.0|-0.93|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.24|-0.93|0.0011
91770525|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.38|-1.07|<0.0001
91770526|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.67|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.67|0.0956
91770527|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0050
91770528|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.18|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.45|-1.18|<0.0001
91770529|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.4|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-1.40|<0.0001
91770530|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0915|TWO_SIDED|95.0|-0.69|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.69|0.0915
91581371|NCT01156792|183052359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.292|||=|0.001|TWO_SIDED|95.0|4.21|16.38|||Mixed Models Analysis|||||16.38|4.21|=0.001
91770531|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0378|TWO_SIDED|95.0|-0.75|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.02|-0.75|0.0378
91770532|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0053|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0053
91770533|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0614|TWO_SIDED|95.0|-0.83|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.08|-0.83|0.0614
91770534|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.92|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.18|-0.92|0.0040
91770535|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.33|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.58|-1.33|<0.0001
91770536|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.47|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.47|<0.0001
91770537|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0967|TWO_SIDED|95.0|-0.7|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.06|-0.70|0.0967
91581372|NCT01156792|183052360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.154|||||TWO_SIDED|95.0|-9.36|1.06||||||||1.06|-9.36|
91770538|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.15|-0.90|0.0063
91770539|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.38|-1.13|<0.0001
91770540|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0632|TWO_SIDED|95.0|-0.75|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.02|-0.75|0.0632
91770541|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.0|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.23|-1.00|0.0020
91790145|NCT02239120|183459405|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9064|TWO_SIDED|95.0|0.58|1.83|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.83|0.58|0.9064
91790146|NCT02239120|183459407|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.4352|TWO_SIDED|95.0|0.49|1.36|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.36|0.49|0.4352
91790147|NCT02239120|183459408|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.0003|TWO_SIDED|95.0|1.12|1.47|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.47|1.12|0.0003
91790148|NCT00603642|183459421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91790149|NCT00603642|183459422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91790150|NCT00603642|183459423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANCOVA|||||||0.0003
91581373|NCT01156792|183052360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.364|||||TWO_SIDED|95.0|-6.22|5.5||||||||5.50|-6.22|
91581374|NCT01156792|183052361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|||=|0.957|TWO_SIDED|95.0|-0.18|0.17|||Mixed Models Analysis|||||0.17|-0.18|=0.957
91581375|NCT01156792|183052361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|||=|0.213|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|||||0.06|-0.28|=0.213
91790151|NCT00603642|183459424|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91790152|NCT00603642|183459425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6015|||||||Fisher Exact|||||||0.6015
91790153|NCT00853996|183459431|OTHER||||||<|0.001||||||No adjustment for multiple comparisons since this was primary endpoint. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91790154|NCT00853996|183459432|OTHER|||||||0.067||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||0.067
91790155|NCT00853996|183459433|OTHER|||||||0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
91790156|NCT00853996|183459434|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.002
91790157|NCT00853996|183459435|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance set at 0.05|Wilcoxon (Mann-Whitney)|||||||0.002
91790158|NCT01607203|183459440|NON_INFERIORITY_OR_EQUIVALENCE|t -test||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
91790159|NCT00548405|183459441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0084|TWO_SIDED|95.0|0.38|0.87||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.||0.87|0.38|0.0084
91790160|NCT00548405|183459442|SUPERIORITY_OR_OTHER||Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.65|0.39|<0.0001
91790161|NCT00548405|183459443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.69|0.41|<0.0001
91790162|NCT00548405|183459444|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||<0.0001
91790163|NCT00548405|183459445|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wei-Lachin|||Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||0.0022
91790164|NCT00548405|183459446|SUPERIORITY_OR_OTHER|||||||0.1371|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.||||0.1371
91790165|NCT03735238|183459502|OTHER|Not applicable. No statistical test was performed for this outcome.||||||||||||||||This is a single arm implementation trial with no comparison group. This outcome represents the reach/penetration of the implementation at each site over the trial duration. We did not perform power calculation. There was no null hypothesis stated. Our aim was to enroll at least 28 patients per site in this implementation trial during regular outpatient rheumatology clinic visits. No statistical test was performed for this outcome.|Our aim was to enroll at least 28 patients per site in this implementation trial during regular outpatient rheumatology clinic visits. No statistical test was performed for this outcome.|||
91791310|NCT00492063|183460305|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-2.0|1.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.||1|-2|
91770542|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.29|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.51|-1.29|<0.0001
91770543|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.48|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.69|-1.48|<0.0001
91770544|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0308|TWO_SIDED|95.0|-0.82|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.04|-0.82|0.0308
91770545|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0105|TWO_SIDED|95.0|-0.89|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.12|-0.89|0.0105
91770546|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.03|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-1.03|0.0010
91770547|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1469|TWO_SIDED|95.0|-0.69|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.69|0.1469
91770548|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0315|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.04|-0.84|0.0315
91770549|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.18|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.38|-1.18|0.0002
91581376|NCT01156792|183052361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||=|0.647|TWO_SIDED|95.0|-0.2|0.12|||Mixed Models Analysis|||||0.12|-0.20|=0.647
91581377|NCT01156792|183052361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|||=|0.894|TWO_SIDED|95.0|-0.17|0.15|||Mixed Models Analysis|||||0.15|-0.17|=0.894
91581378|NCT01156792|183052362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||=|0.811|TWO_SIDED|95.0|-0.23|0.18|||Mixed Models Analysis|||||0.18|-0.23|=0.811
91581379|NCT01156792|183052362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||=|0.2|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||||0.07|-0.34|=0.200
91770550|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-1.26|<0.0001
91770551|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4494|TWO_SIDED|95.0|-0.56|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.25|-0.56|0.4494
91770552|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0595|TWO_SIDED|95.0|-0.79|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.02|-0.79|0.0595
91770553|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0065|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-0.96|0.0065
91770554|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.77|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.04|-0.77|0.0745
91581380|NCT01156792|183052362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|||=|0.415|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||||0.11|-0.26|=0.415
91581381|NCT01156792|183052362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||=|0.358|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|=0.358
91581382|NCT01156792|183052363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.666|||=|0.285|TWO_SIDED|95.0|-2.24|7.57|||Mixed Models Analysis|||||7.57|-2.24|=0.285
91770555|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.054|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.01|-0.80|0.0540
91770556|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0001|TWO_SIDED|95.0|-1.22|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.41|-1.22|0.0001
91770557|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.43|-1.26|<0.0001
91770558|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.5317|TWO_SIDED|95.0|-0.54|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.54|0.5317
91770559|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0424|TWO_SIDED|95.0|-0.83|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.01|-0.83|0.0424
91770560|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0134|TWO_SIDED|95.0|-0.91|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.11|-0.91|0.0134
91770561|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0300
91770562|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0605|TWO_SIDED|95.0|-0.78|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.02|-0.78|0.0605
91770563|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|-1.2|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.40|-1.20|0.0001
91770564|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.56|-1.38|<0.0001
91770565|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1848|TWO_SIDED|95.0|-0.68|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.13|-0.68|0.1848
91770566|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0321|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0321
91770567|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0025|TWO_SIDED|95.0|-1.01|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.22|-1.01|0.0025
91770568|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0441|TWO_SIDED|95.0|-0.81|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.81|0.0441
91770569|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0422|TWO_SIDED|95.0|-0.82|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.82|0.0422
91770570|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.45|-1.27|<0.0001
91770571|NCT03192176|183427575|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.44|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-1.44|<0.0001
91770572|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1464|TWO_SIDED|95.0|-0.71|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.11|-0.71|0.1464
91770573|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0144|TWO_SIDED|95.0|-0.91|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.10|-0.91|0.0144
91770574|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0013|TWO_SIDED|95.0|-1.06|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.26|-1.06|0.0013
91770575|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0596|TWO_SIDED|95.0|-0.8|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.02|-0.80|0.0596
91770576|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.036|TWO_SIDED|95.0|-0.85|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.03|-0.85|0.0360
91581383|NCT01156792|183052363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|||=|0.035|TWO_SIDED|95.0|0.38|10.22|||Mixed Models Analysis|||||10.22|0.38|=0.035
91581384|NCT01156792|183052363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.036|||=|0.09|TWO_SIDED|95.0|-0.63|8.7|||Mixed Models Analysis|||||8.70|-0.63|=0.090
91770577|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0006|TWO_SIDED|95.0|-1.15|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.32|-1.15|0.0006
91770578|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.23|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.39|-1.23|0.0002
91581385|NCT01156792|183052363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.602|||=|0.047|TWO_SIDED|95.0|0.06|9.14|||Mixed Models Analysis|||||9.14|0.06|=0.047
91770579|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3227|TWO_SIDED|95.0|-0.62|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.21|-0.62|0.3227
91770580|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.89|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.07|-0.89|0.0220
91770581|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.038|TWO_SIDED|95.0|-0.84|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.02|-0.84|0.0380
91770582|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.6|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.10|-0.60|0.0067
91770583|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1227|TWO_SIDED|95.0|-0.45|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.05|-0.45|0.1227
91770584|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0208|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.05|-0.57|0.0208
91770585|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2396|TWO_SIDED|95.0|-0.41|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.10|-0.41|0.2396
91770586|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0022|TWO_SIDED|95.0|-0.67|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.15|-0.67|0.0022
91770587|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0479|TWO_SIDED|95.0|-0.53|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.53|0.0479
91581386|NCT01156792|183052364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
91770588|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4152|TWO_SIDED|95.0|-0.35|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.15|-0.35|0.4152
91770589|NCT03192176|183427575|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0262|TWO_SIDED|95.0|-0.52|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.03|-0.52|0.0262
91770590|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.121|TWO_SIDED|95.0|-0.43|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.05|-0.43|0.1210
91770591|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0369|TWO_SIDED|95.0|-0.52|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.02|-0.52|0.0369
91581387|NCT01156792|183052364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
91770592|NCT03192176|183427575|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5855|TWO_SIDED|95.0|-0.32|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.18|-0.32|0.5855
91770593|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0041|TWO_SIDED|95.0|-0.62|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.12|-0.62|0.0041
91581388|NCT01156792|183052364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
91581389|NCT01156792|183052364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
91581390|NCT01156792|183052365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.992|||=|0.367|TWO_SIDED|95.0|-2.35|6.33|||Mixed Models Analysis|||||6.33|-2.35|=0.367
91770594|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0614|TWO_SIDED|95.0|-0.5|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.01|-0.50|0.0614
91581391|NCT01156792|183052365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.147|||=|0.332|TWO_SIDED|95.0|-2.2|6.49|||Mixed Models Analysis|||||6.49|-2.20|=0.332
91581392|NCT01156792|183052365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.331|||=|0.277|TWO_SIDED|95.0|-1.88|6.55|||Mixed Models Analysis|||||6.55|-1.88|=0.277
91581393|NCT01156792|183052365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.521|||=|0.467|TWO_SIDED|95.0|-2.59|5.63|||Mixed Models Analysis|||||5.63|-2.59|=0.467
91581394|NCT01156792|183052366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|||=|0.789|TWO_SIDED|95.0|-3.65|4.8|||Mixed Models Analysis|||||4.80|-3.65|=0.789
91581395|NCT01156792|183052366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||=|0.087|TWO_SIDED|95.0|-0.54|7.87|||Mixed Models Analysis|||||7.87|-0.54|=0.087
91581396|NCT01156792|183052366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.923|TWO_SIDED|95.0|-3.84|4.24|||Mixed Models Analysis|||||4.24|-3.84|=0.923
91581397|NCT01156792|183052366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.137|||=|0.571|TWO_SIDED|95.0|-5.08|2.81|||Mixed Models Analysis|||||2.81|-5.08|=0.571
91518609|NCT01570829|182911572|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
91581398|NCT01156792|183052367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
91581399|NCT01156792|183052367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
91581400|NCT01156792|183052367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
91581401|NCT01156792|183052367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
91581402|NCT01156792|183052368|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
91581403|NCT01156792|183052368|SUPERIORITY_OR_OTHER||||||=|0.138||95.0|||||Fisher Exact|||||||=0.138
91581404|NCT01156792|183052368|SUPERIORITY_OR_OTHER||||||=|0.797||95.0|||||Fisher Exact|||||||=0.797
91581405|NCT01156792|183052368|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
91581406|NCT02585232|183052411|SUPERIORITY|||||||0.483|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline caregiver burden scores were included in the model as covariates.||||||.483
91581407|NCT02585232|183052412|SUPERIORITY|||||||0.169|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline Dyadic Adjustment Scale scores were included as covariates.||Only caregivers that were currently or previously in a romantic relationship (e.g., spouses, partners) with the person with dementia reported on the Dyadic Adjustment Scale (i.e., N = 20, n = 9 in CC group and n = 11 in CC+C group).||||0.169
91581408|NCT02585232|183052413|SUPERIORITY|||||||0.763|||||||ANCOVA|Baseline quality of life scores, education, and cognitive status were included as covariates in the model.||||||0.763
91581409|NCT02585232|183052414|SUPERIORITY|||||||0.78|||||||ANCOVA|Baseline depression scores, cognitive status scores (i.e., MoCA), and education were included in the model as covariates.||||||0.780
91581410|NCT03618823|183052423|EQUIVALENCE|All pain scores were included due to the sample size. Alpha =.05 Power = .80 Desired effect size of 0.30 Size of n=145 in each group was determined, however this was not reached for sufficient power.||||||0.912|||||||Mixed Models Analysis|Two-way mixed-model analysis of variance||There will be no difference in pain scores between opioid and non-opioid groups from before medication to after while controlling for total duration of mediation use (duration mean=10.11 days).||||.912
91581411|NCT03618823|183052424|SUPERIORITY||Odds Ratio (OR)|1.311||||0.63|TWO_SIDED|95.0|0.494|3.478|||Fisher Exact|||There will be no difference in ED (Emergency Department) or urgent care visits between opioid and non-opioid pain control groups.||3.478|.494|.630
91581412|NCT05383508|183052437|OTHER||Geometric LS Mean Ratio (%)|17.05|||||TWO_SIDED|95.0|10.69|27.19||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||27.19|10.69|
91581413|NCT05383508|183052437|OTHER||Geometric LS Mean Ratio (%)|19.47|||||TWO_SIDED|95.0|11.89|31.87||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||31.87|11.89|
91581414|NCT05383508|183052438|OTHER||Median Difference (Net)|3.0|||||TWO_SIDED|95.0|0.0|11.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||11.00|0.00|
91581415|NCT05383508|183052438|OTHER||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|0.0|4.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||4.00|0.00|
91581416|NCT05383508|183052439|OTHER||Geometric LS Mean Ratio (%)|28.29|||||TWO_SIDED|95.0|16.0|50.04||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||50.04|16.00|
91581417|NCT05383508|183052439|OTHER||Geometric LS Mean Ratio (%)|26.16|||||TWO_SIDED|95.0|12.74|53.69||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||53.69|12.74|
91581418|NCT05383508|183052440|OTHER||Geometric LS Mean Ratio (%)|10.84|||||TWO_SIDED|95.0|5.57|21.1||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||21.10|5.57|
91581419|NCT05383508|183052440|OTHER||Geometric LS Mean Ratio (%)|16.83|||||TWO_SIDED|95.0|9.93|28.53||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||28.53|9.93|
91581420|NCT01506609|183052475|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.227|TWO_SIDED|95.0|0.536|1.162|||Log Rank|||||1.162|0.536|0.227
91581421|NCT01506609|183052475|SUPERIORITY||Hazard Ratio (HR)|1.858||||0.001|TWO_SIDED|95.0|1.278|2.702|||Log Rank|||||2.702|1.278|0.001
91581422|NCT01506609|183052476|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.368|TWO_SIDED|95.0|0.59|1.218|||Log Rank|||||1.218|0.590|0.368
91581423|NCT01506609|183052476|SUPERIORITY||Hazard Ratio (HR)|1.512||||0.017|TWO_SIDED|95.0|1.074|2.127|||Log Rank|||||2.127|1.074|0.017
91581424|NCT01506609|183052477|SUPERIORITY|||||||0.434||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.434
91581425|NCT01506609|183052477|SUPERIORITY|||||||0.019||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.019
91581426|NCT01506609|183052478|SUPERIORITY|||||||0.027||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.027
91581427|NCT01506609|183052478|SUPERIORITY||||||<|0.001||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||< 0.001
91581428|NCT01506609|183052479|SUPERIORITY||Least Squares (LS) Mean of Difference|-2.302|STANDARD_ERROR_OF_MEAN|2.476||0.354|TWO_SIDED|95.0|-7.2|2.6||ANCOVA with treatment arm and baseline value as covariate.|ANCOVA|||||2.60|-7.20|0.354
91581429|NCT05121246|183052571|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
91581430|NCT05121246|183052572|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
91581431|NCT00935818|183052586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.03|TWO_SIDED|95.0|1.05|2.12|||Regression, Logistic|||Logistic regression with covariate included for study site.||2.12|1.05|0.03
91581432|NCT00935818|183052587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.03|TWO_SIDED|95.0|1.04|2.22|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.22|1.04|0.03
91581433|NCT00935818|183052588|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||< 0.001
91581434|NCT00935818|183052589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.93|||Regression, Logistic|||Logistic regression adjusted for study site||1.93|0.95|0.09
91581435|NCT00935818|183052590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.14|TWO_SIDED|95.0|0.91|1.91|||Regression, Logistic|||Logistic Regression adjusting for study site||1.91|0.91|0.14
91581436|NCT00935818|183052591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.11|TWO_SIDED|95.0|0.93|2.07|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.07|0.93|0.11
91581437|NCT00935818|183052592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.08|TWO_SIDED|95.0|0.96|2.05|||Regression, Logistic|||Logistic Regression - adjusting for site||2.05|0.96|0.08
91581438|NCT00604825|183052634|SUPERIORITY||Adjusted Mean Difference|0.75||||0.215|TWO_SIDED|95.0|-0.44|1.93||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||1.93|-0.44|0.215
91581439|NCT00604825|183052634|SUPERIORITY||Adjusted Mean Difference|1.21||||0.041|TWO_SIDED|95.0|0.05|2.37||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||2.37|0.05|0.041
91581440|NCT00604825|183052634|SUPERIORITY||Adjusted Mean Difference|-2.06|||<|0.001|TWO_SIDED|95.0|-3.2|-0.92||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.92|-3.20|<0.001
91581441|NCT00604825|183052635|SUPERIORITY||Adjusted Mean Difference|0.15||||0.202|TWO_SIDED|95.0|-0.08|0.38||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||0.38|-0.08|0.202
91581442|NCT00604825|183052635|SUPERIORITY||Adjusted Mean Difference|0.31||||0.008|TWO_SIDED|95.0|0.08|0.54||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||0.54|0.08|0.008
91581443|NCT00604825|183052635|SUPERIORITY||Adjusted Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.3||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.30|-0.75|<0.001
91613577|NCT01899144|183121465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.6|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|13.0|32.2|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||32.20|13.00|<0.0001
91581444|NCT03465904|183052678|SUPERIORITY|Our power analysis indicated that a minimum of 239 patients per group was needed to provide 90% power to detect a 13.4% difference in the primary outcome, pain freedom at 2 h. Accounting for an estimated attrition rate of 20%, we aimed to enroll 299 patients per group.|||||<|0.05||||||All analyses were performed using SPSS, version 26.0 with two-sided levels of statistical significance established at p \< 0.05|Chi-squared|A Chi-square test of independent proportions was used to compare primary and secondary efficacy outcomes between groups.||Identical statistical analyses were performed for the intent-to-treat (ITT) and the per protocol (PP) populations. The ITT population consisted of all randomized patients, who received any duration of sham or verum treatment and returned completed study materials. The PP population consisted of patients who strictly met inclusion criteria and completed at least 60 min of treatment.||||<0.05
91581445|NCT05593445|183052679|SUPERIORITY||Odds Ratio (OR)|0.83||||0.737|TWO_SIDED|95.0|0.29|2.41|||Chi-squared|||||2.41|0.29|0.737
91581446|NCT05593445|183052679|SUPERIORITY||response rate difference|-4.3|STANDARD_ERROR_OF_MEAN|12.73|||TWO_SIDED|95.0|-29.2|20.7|||||The 95% confidence interval for the response rate difference was constructed from approximately normal distribution.|||20.7|-29.2|
91581447|NCT05593445|183052680|SUPERIORITY||least squares mean difference|-2.76|STANDARD_ERROR_OF_MEAN|1.14||0.0188|TWO_SIDED|95.0|-5.05|-0.47|||Mixed Model Repeated Measures (MMRM)|||||-0.47|-5.05|0.0188
91581448|NCT05593445|183052681|SUPERIORITY||least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.72||0.4674|TWO_SIDED|95.0|-1.96|0.91|||MMRM|||||0.91|-1.96|0.4674
91581449|NCT05593445|183052682|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9072|TWO_SIDED|95.0|0.503|1.869|||Log Rank||Cox regression model was conducted to compare the difference in hazard rate.|||1.869|0.503|0.9072
91581450|NCT00925353|183052691|SUPERIORITY_OR_OTHER||Actual lab results shown|1.0|||<|0.05||95.0|||||non-compartmental pharmacokinetic|The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.||Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.||||<0.05
91581451|NCT00153062|183052733|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin of 1.075|Hazard Ratio (HR)|1.01||||0.783|TWO_SIDED|95.0|0.92|1.11|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs clopidogrel||1.11|0.92|0.7830
91581452|NCT00153062|183052734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8292|TWO_SIDED|95.0|0.92|1.07|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs Clopidogrel||1.07|0.92|0.8292
91581453|NCT00153062|183052735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.1073|TWO_SIDED|95.0|0.87|1.01|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.||Telmisartan vs Placebo||1.01|0.87|0.1073
91581454|NCT00153062|183052736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.65|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates||Telmisartan vs Placebo||1.04|0.65|0.1007
91581455|NCT00153062|183052737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2312|TWO_SIDED|95.0|0.86|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates||Telmisartan vs placebo||1.04|0.86|0.2312
91581456|NCT00189488|183052750|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-17.9||||0.034|TWO_SIDED|95.0|-33.4|-2.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||-2.4|-33.4|0.034
91770595|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3391|TWO_SIDED|95.0|-0.36|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-0.36|0.3391
91770596|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0515|TWO_SIDED|95.0|-0.49|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.00|-0.49|0.0515
91581457|NCT00189488|183052751|SUPERIORITY_OR_OTHER||Adjusted Difference (%)|0.5||||0.929|TWO_SIDED|95.0|-11.0|12.1|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with severe GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||12.1|-11.0|0.929
91581458|NCT00189488|183052752|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-6.5||||0.352|TWO_SIDED|95.0|-19.4|6.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Day 11 Methotrexate GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||6.4|-19.4|0.352
91581459|NCT00189488|183052753|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-2.6||||0.675|TWO_SIDED|95.0|-14.2|9.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with severe oral mucositis, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|"Participants with Unknown incidence are treated as Yes when constructing the differences, 95% confidence intervals and p-value."||9.0|-14.2|0.675
91581460|NCT00189488|183052754|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.5||||0.953|TWO_SIDED|95.0|-1.5|2.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||2.5|-1.5|0.953
91581461|NCT00189488|183052755|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|2.0||||0.797|TWO_SIDED|95.0|-12.5|16.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with opioid analgesic use, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||16.5|-12.5|0.797
91581462|NCT00189488|183052756|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-5.5||||0.186|TWO_SIDED|95.0|-12.7|1.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||1.8|-12.7|0.186
91770597|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0667|TWO_SIDED|95.0|-0.47|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.02|-0.47|0.0667
91581463|NCT00189488|183052757|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-4.1||||0.219|TWO_SIDED|5.0|-12.2|4.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||4.0|-12.2|0.219
91581464|NCT01143038|183052758|SUPERIORITY_OR_OTHER_LEGACY||Mean|9.2|||||TWO_SIDED|95.0|8.3|10.1|||||Based on the t-distribution|||10.1|8.3|
91581465|NCT01143038|183052758|SUPERIORITY_OR_OTHER_LEGACY||Bootstrap mean|9.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|8.3|10.0|||||Estimates are based on bootstrap method with 1000 samples with replacement.|Bootstrap analysis||10.0|8.3|
91581466|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||ANOVA|||Region of Interest is left anterior insula.||||0.2960
91581467|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||Region of interest is left anterior insula.||||0.3450
91770598|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0047|TWO_SIDED|95.0|-0.63|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.63|0.0047
91581468|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.1192||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.1192
91581469|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.6639
91581470|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.8295||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.8295
91581471|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.0078
91581472|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex.||||0.7153
91581473|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.8511||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex||||0.8511
91581474|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.4228||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.4228
91581475|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.0611||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.0611
91581476|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.9879||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.9879
91581477|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.2065||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.2065
91581478|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.1837||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.1837
91581479|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.8195||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.8195
91581480|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||ANOVA|||Region of interest is left thalamus||||0.6420
91581481|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.7475||95.0|||||ANOVA|||Region of interest is left thalamus||||0.7475
91581482|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.9049||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.9049
91581483|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.1830
91581484|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.5318||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.5318
91581485|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.9588||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.9588
91581486|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.7551||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7551
91581487|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.7895||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7895
91581488|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.9494||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.9494
91581489|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.4482||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.4482
91581490|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.9343
91581491|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.7711||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.7711
91581492|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.4755||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.4755
91581493|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.3982||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.3982
91770599|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.513|TWO_SIDED|95.0|-0.34|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.34|0.5130
91581494|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.4622||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4622
91581495|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.4604||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4604
91581496|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.2485||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.2485
91581497|NCT00657020|183052763|SUPERIORITY_OR_OTHER|||||||0.1931||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.1931
91581498|NCT00657020|183052764|SUPERIORITY_OR_OTHER|||||||0.4535||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.4535
91581499|NCT00657020|183052764|SUPERIORITY_OR_OTHER|||||||0.1811||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.1811
91581500|NCT00657020|183052765|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.6261
91581501|NCT00657020|183052765|SUPERIORITY_OR_OTHER|||||||0.0106||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.0106
91581502|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.5544
91581503|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.6716||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.6716
91581504|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.7511||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7511
91581505|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.7959||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7959
91581506|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.6418||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.6418
91581507|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.2205||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.2205
91581508|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.5135||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.5135
91581509|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.9781||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.9781
91581510|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.3755||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.3755
91581511|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.2612||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.2612
91581512|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.8486||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8486
91581513|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.8318||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8318
91581514|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.7554||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.7554
91581515|NCT00657020|183052766|SUPERIORITY_OR_OTHER|||||||0.5421||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.5421
91581516|NCT00657020|183052767|SUPERIORITY_OR_OTHER|||||||0.1963||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.1963
91581517|NCT00657020|183052767|SUPERIORITY_OR_OTHER|||||||0.0959||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.0959
91581518|NCT00657020|183052768|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.5400
91581519|NCT00657020|183052768|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Null hypothesis considered the treatments in comparison to be equal.||||0.1800
91581520|NCT01183234|183052769|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.953|||||TWO_SIDED|90.0|0.915|0.993|||Mixed Models Analysis|||||0.993|0.915|
91581521|NCT01183234|183052770|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.988|||||TWO_SIDED|90.0|0.931|1.05|||Mixed Models Analysis|||||1.05|0.931|
91581522|NCT01183234|183052771|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.15|0.492|||Wilcoxon (Hodges-Lehmann)|||||0.492|-0.150|
91581523|NCT00370331|183052780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.2|||<|0.001||99.0|3.59|18.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized Estimating Equations (GEE)||||18.73|3.59|<0.001
91581524|NCT02313233|183052808|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91581525|NCT02313233|183052809|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91581526|NCT02313233|183052812|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91581527|NCT02313233|183052813|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91581528|NCT01859988|183052816|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-55.7|STANDARD_ERROR_OF_MEAN|6.74|<|0.0001|TWO_SIDED|95.0|-68.9|-42.4||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w \& 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.||-42.4|-68.9|<0.0001
91581529|NCT01859988|183052816|SUPERIORITY_OR_OTHER||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|6.67|<|0.0001|TWO_SIDED|95.0|-63.3|-37.0||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.0|-63.3|<0.0001
91581530|NCT01859988|183052816|SUPERIORITY_OR_OTHER||LS mean difference|-47.4|STANDARD_ERROR_OF_MEAN|6.76|<|0.0001|TWO_SIDED|95.0|-60.6|-34.1||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 200 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.1|-60.6|<0.0001
91581531|NCT01859988|183052816|SUPERIORITY_OR_OTHER||LS mean difference|-45.4|STANDARD_ERROR_OF_MEAN|6.66|<|0.0001|TWO_SIDED|95.0|-58.5|-32.3||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.3|-58.5|<0.0001
91581532|NCT01859988|183052816|SUPERIORITY_OR_OTHER||LS mean difference|-26.8|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.8|-13.7||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 100 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.7|-39.8|<0.0001
91581533|NCT00652327|183052830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Wilcoxon rank sum test|||||||.0026
91581534|NCT02224690|183052848|SUPERIORITY||Median Difference (Final Values)|-17.21||||0.0135|TWO_SIDED|95.0|-30.32|-4.09|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.09|-30.32|0.0135
91581535|NCT02224690|183052849|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0043|TWO_SIDED|95.0|1.33|4.97|||Cochran-Mantel-Haenszel|Calculated using a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)||||4.97|1.33|0.0043
91581536|NCT02224690|183052850|SUPERIORITY||Mean Difference (Final Values)|-21.13||||0.0005|TWO_SIDED|95.0|-33.26|-9.37|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-9.37|-33.26|0.0005
91581537|NCT02224690|183052851|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0012|TWO_SIDED|95.0|1.45|4.47|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor.|Odds of participants recording a lower score (improvement) on a continuous scale|||4.47|1.45|0.0012
91770600|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.75|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.23|-0.75|0.0002
91581538|NCT00577473|183052860|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0455||||0.4411|TWO_SIDED|95.0|-7.01|16.11||4.8 g/day compared to 2.4 g/day|Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||16.11|-7.01|0.4411
91581539|NCT00577473|183052861|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0331||||0.5677|TWO_SIDED|95.0|-14.67|8.04|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||8.04|-14.67|0.5677
91581540|NCT00577473|183052862|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0445||||0.473|TWO_SIDED|95.0|-16.6|7.7|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||7.7|-16.6|0.4730
91770601|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0126|TWO_SIDED|95.0|-0.6|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.07|-0.60|0.0126
91581541|NCT00577473|183052863|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0339||||0.5761|TWO_SIDED|95.0|-8.48|15.26|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.26|-8.48|0.5761
91581542|NCT00577473|183052864|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0766||||0.215|TWO_SIDED|95.0|-4.41|19.74|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.74|-4.41|0.2150
91581543|NCT00577473|183052865|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0351||||0.5569|TWO_SIDED|95.0|-8.18|15.2|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.20|-8.18|0.5569
91581544|NCT00577473|183052866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1091||||0.0769|TWO_SIDED|95.0|-1.1|22.91|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.91|-1.10|0.0769
91706173|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.46||||0.234|TWO_SIDED|90.0|-10.08|43.7|||Barnard-Exact test|||Day 14||43.70|-10.08|0.2340
91581545|NCT00577473|183052867|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1139||||0.0551|TWO_SIDED|95.0|-0.13|22.92|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.92|-0.13|0.0551
91581546|NCT00577473|183052868|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0738||||0.2306|TWO_SIDED|95.0|-4.66|19.43|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.43|-4.66|0.2306
91581547|NCT00577473|183052869|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0652||||0.2931|TWO_SIDED|95.0|-5.6|18.64|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||18.64|-5.60|0.2931
91581548|NCT00577473|183052870|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0051||||0.9349|TWO_SIDED|95.0|-11.67|12.69|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||12.69|-11.67|0.9349
91581549|NCT00577473|183052871|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.065||||0.2583|TWO_SIDED|95.0|-4.72|17.73|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||17.73|-4.72|0.2583
91581550|NCT02595073|183052872|SUPERIORITY|||||||0.3353|||||||z-test, 2-tailed|||||||0.3353
91581551|NCT02595073|183052873|SUPERIORITY|||||||0.619|||||||ANCOVA|||||||0.6190
91581552|NCT02884908|183052882|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.8|||||||Mixed Models Analysis|||||||0.80
91581553|NCT02884908|183052883|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.9|||||||Mixed Models Analysis|||||||0.90
91581554|NCT02884908|183052884|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.38|||||||Mixed Models Analysis|||||||0.38
91581555|NCT01856868|183052976|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
91581556|NCT01856868|183052977|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0185|||||||t-test, 2 sided|||||||0.0185
91581557|NCT01856868|183052978|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
91581558|NCT01856868|183052979|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0078|||||||t-test, 2 sided|||||||0.0078
91581559|NCT01856868|183052980|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0025|||||||t-test, 2 sided|||||||0.0025
91581560|NCT01856868|183052981|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0082|||||||t-test, 2 sided|||||||0.0082
91581561|NCT01856868|183052982|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.031|||||||t-test, 2 sided|||||||0.031
91581562|NCT01856868|183052983|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
91581563|NCT01856868|183052984|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0321|||||||t-test, 2 sided|||||||0.0321
91581564|NCT01856868|183052985|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0182|||||||t-test, 2 sided|||||||0.0182
91581565|NCT01856868|183052986|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0371|||||||t-test, 2 sided|||||||0.0371
91581566|NCT01856868|183052987|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0257|||||||t-test, 2 sided|||||||0.0257
91581567|NCT01856868|183052990|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height and weight using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|-1.82|STANDARD_ERROR_OF_MEAN|2.51||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
91581568|NCT01856868|183052991|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|11.2|STANDARD_ERROR_OF_MEAN|16.6||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
91581569|NCT01856868|183052993|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|5.33|STANDARD_ERROR_OF_MEAN|3.79||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
91581570|NCT02632526|183053022|SUPERIORITY_OR_OTHER||Slope|1.24|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|1.17|1.31||||||||1.31|1.17|
91581571|NCT02632526|183053022|SUPERIORITY_OR_OTHER||Slope|0.322|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.0124|0.656||||||||0.656|-0.0124|
91581572|NCT02632526|183053023|SUPERIORITY_OR_OTHER||Slope|1.22|STANDARD_ERROR_OF_MEAN|0.0813|||TWO_SIDED|90.0|1.08|1.36||||||Day 1||1.36|1.08|
91581573|NCT02632526|183053025|SUPERIORITY_OR_OTHER||Slope|1.23|STANDARD_ERROR_OF_MEAN|0.0851|||TWO_SIDED|90.0|1.08|1.38||||||Day 10||1.38|1.08|
91581574|NCT02632526|183053026|SUPERIORITY_OR_OTHER||Slope|1.55|STANDARD_ERROR_OF_MEAN|0.0692|||TWO_SIDED|90.0|1.43|1.66||||||||1.66|1.43|
91581575|NCT02632526|183053026|SUPERIORITY_OR_OTHER||Slope|0.35|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|0.0315|0.669||||||||0.669|0.0315|
91581576|NCT02632526|183053027|SUPERIORITY_OR_OTHER||Slope|1.48|STANDARD_ERROR_OF_MEAN|0.0839|||TWO_SIDED|90.0|1.34|1.63||||||For Day 1||1.63|1.34|
91581577|NCT02632526|183053027|SUPERIORITY_OR_OTHER||Slope|1.43|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|1.25|1.6||||||Day 10||1.60|1.25|
91581578|NCT02632526|183053040|SUPERIORITY_OR_OTHER||Ratio|28.13|||||TWO_SIDED|90.0|20.98|37.73||||||Cmax||37.73|20.98|
91581579|NCT02632526|183053041|SUPERIORITY_OR_OTHER||Ratio|64.58|||||TWO_SIDED|90.0|54.34|76.74||||||AUC(0-τ)||76.74|54.34|
91581580|NCT03954392|183053054|OTHER||||||<|0.05|||||||ANCOVA|Only one statistical test was conducted, therefore no adjustments for multiple comparisons was needed.||Statistical analysis will compare the post-intervention scores on the primary outcome (Faux Pas Recognition Test scores), controlling for pre-intervention scores.||||< 0.05
91581581|NCT03954392|183053055|OTHER||||||<|0.05|||||||ANCOVA|||||||< 0.05
91581582|NCT00998335|183053139|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||Baseline versus 3 months||||0.03
91581583|NCT05559476|183053163|NON_INFERIORITY|The non-inferiority is demonstrated if the Upper Limit (UL) of the 2-sided 95% Confidence Interval (CI) of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is less than or equal (\<=)1.5.|GMT Ratio|1.18|||||TWO_SIDED|95.0|1.03|1.35|||||The comparison is done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.35|1.03|
91581584|NCT05559476|183053164|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.16|0.85|
91581585|NCT05559476|183053164|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.09|0.80|
91581586|NCT05559476|183053164|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.88|1.03|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.03|0.88|
91581587|NCT05559476|183053164|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.02|0.84|
91581588|NCT05559476|183053165|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is \<=1.5.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.15|0.89|
91581589|NCT05559476|183053166|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-1.71|||||TWO_SIDED|95.0|-8.15|4.74||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||4.74|-8.15|
91581590|NCT05559476|183053166|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-4.11|||||TWO_SIDED|95.0|-10.67|2.48||||||To evaluate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||2.48|-10.67|
91581591|NCT05559476|183053166|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-8.56|||||TWO_SIDED|95.0|-14.75|-2.29||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||-2.29|-14.75|
91581592|NCT05559476|183053166|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-5.89|||||TWO_SIDED|95.0|-12.28|0.56||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||0.56|-12.28|
91581593|NCT02349425|183053216|SUPERIORITY||Estimated percent change|-41.222||||0.0055|TWO_SIDED|95.0|-59.294|-15.127|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.127|-59.294|0.0055
91581594|NCT02349425|183053216|SUPERIORITY||Estimated percent change|-51.973||||0.0008|TWO_SIDED|95.0|-68.23|-27.397|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-27.397|-68.230|0.0008
91581595|NCT02349425|183053216|SUPERIORITY||Estimated percent change|-46.853||||0.0075|TWO_SIDED|95.0|-66.291|-16.206|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.206|-66.291|0.0075
91643119|NCT02712359|183178575|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 8 Group minus Havrix 2 doses\_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-23.33|||<|0.0001|TWO_SIDED|95.0|-28.78|-18.29|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.||-18.29|-28.78|<0.0001
91643120|NCT02712359|183178576|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 10 Group minus Havrix 2 doses\_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-24.43|||<|0.0001|TWO_SIDED|95.0|-30.11|-19.03|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.||-19.03|-30.11|<0.0001
91643121|NCT03126682|183178629|SUPERIORITY|||||||0.212||||||Threshold of \<0.05|t-test, 2 sided|||||||0.212
91643122|NCT00798707|183178630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.452|TWO_SIDED|95.0|-0.75|1.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||1.69|-0.75|0.452
91643123|NCT00798707|183178630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.016|TWO_SIDED|95.0|0.28|2.72||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||2.72|0.28|0.016
91643124|NCT00798707|183178631|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.160
91643125|NCT00798707|183178631|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.028
91643126|NCT00798707|183178632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.066|TWO_SIDED|95.0|-0.01|0.39|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.39|-0.01|0.066
91643127|NCT00798707|183178632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.038|TWO_SIDED|95.0|0.01|0.41|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.41|0.01|0.038
91643128|NCT00798707|183178633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.242|TWO_SIDED|95.0|-0.68|2.68|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.68|-0.68|0.242
91643129|NCT00798707|183178633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||0.016|TWO_SIDED|95.0|0.39|3.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.73|0.39|0.016
91643130|NCT00798707|183178634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.802|TWO_SIDED|95.0|-0.62|0.8|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.80|-0.62|0.802
91643131|NCT00798707|183178634|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72||||0.048|TWO_SIDED|95.0|0.01|1.43|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.43|0.01|0.048
91643132|NCT00798707|183178635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.363||||0.1099|TWO_SIDED|95.0|0.93|1.99|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.99|0.93|0.1099
91643133|NCT00798707|183178635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.0154|TWO_SIDED|95.0|1.09|2.32|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.32|1.09|0.0154
91643134|NCT00798707|183178636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.878||||0.5929|TWO_SIDED|95.0|0.54|1.41|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.41|0.54|0.5929
91643135|NCT00798707|183178636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.474||||0.0852|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.29|0.95|0.0852
91643136|NCT00798707|183178637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.277||||0.2232|TWO_SIDED|95.0|0.86|1.89|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.89|0.86|0.2232
91643137|NCT00798707|183178637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||0.0022|TWO_SIDED|95.0|1.24|2.69|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||2.69|1.24|0.0022
91643138|NCT00798707|183178638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.158||||0.4313|TWO_SIDED|95.0|0.8|1.67|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.67|0.80|0.4313
91643139|NCT00798707|183178638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.0888|TWO_SIDED|95.0|0.95|1.97|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.97|0.95|0.0888
91643140|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.073|TWO_SIDED|95.0|-0.1|2.29|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.29|-0.10|0.073
91643141|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.06||||0.078|TWO_SIDED|95.0|-0.12|2.24|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.24|-0.12|0.078
91643142|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.176|TWO_SIDED|95.0|-0.13|0.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.73|-0.13|0.176
91643143|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.109|TWO_SIDED|95.0|-0.08|0.77|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.77|-0.08|0.109
91643144|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.064|TWO_SIDED|95.0|-0.02|0.84|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.84|-0.02|0.064
91643145|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.104|TWO_SIDED|95.0|-0.07|0.78|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.78|-0.07|0.104
91643146|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.538|TWO_SIDED|95.0|-2.98|5.57|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.||5.57|-2.98|0.538
91643147|NCT00798707|183178640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.689|TWO_SIDED|95.0|-1.76|2.62|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score||2.62|-1.76|0.689
91643148|NCT00798707|183178641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.066|TWO_SIDED|95.0|-1.67|0.05|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.05|-1.67|0.066
91643149|NCT00798707|183178641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.15|TWO_SIDED|95.0|-1.48|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-1.48|0.150
91643150|NCT00798707|183178642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.8758|TWO_SIDED|95.0|0.51|1.78|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.78|0.51|0.8758
91643151|NCT00798707|183178642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.6397|TWO_SIDED|95.0|0.61|2.21|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||2.21|0.61|0.6397
91643152|NCT00798707|183178644|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
91643153|NCT00798707|183178644|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
91643154|NCT00798707|183178644|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
91643155|NCT00798707|183178644|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
91643156|NCT00798707|183178644|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
91643157|NCT00798707|183178644|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
91643158|NCT01299272|183178666|SUPERIORITY_OR_OTHER|||||||0.485|||||||Log Rank|||||||0.485
91770602|NCT03192176|183427575|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3507|TWO_SIDED|95.0|-0.36|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.13|-0.36|0.3507
91643159|NCT00464308|183178695|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.11|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|Non-inferiority||Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
91643160|NCT00464308|183178698|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.051|||<|0.05||95.0||||All statistical tests were interpreted at the 5% significance level (2-tailed).|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
91643161|NCT00464308|183178699|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.053|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
91643162|NCT00464308|183178700|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.061|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
91643163|NCT03926728|183178722|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
91643164|NCT03926728|183178722|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
91643165|NCT03926728|183178722|OTHER|||||||0.0007|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.0007
91770603|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0098|TWO_SIDED|95.0|-0.6|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.60|0.0098
91643166|NCT03926728|183178725|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
91643167|NCT03926728|183178725|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
91643168|NCT03926728|183178726|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
91643169|NCT03926728|183178726|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
91643170|NCT03926728|183178728|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
91643171|NCT03926728|183178728|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
91643172|NCT03926728|183178728|OTHER|||||||0.3229|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.3229
91643173|NCT01107834|183178750|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.27
91643174|NCT01107834|183178751|SUPERIORITY_OR_OTHER|||||||0.46|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.46
91643175|NCT01107834|183178752|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.13
91643176|NCT01107834|183178753|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.59
91643177|NCT01107834|183178754|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.09
91643178|NCT01107834|183178755|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.03
91770604|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED|95.0|-0.63|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.11|-0.63|0.0048
91643179|NCT03722849|183178756|OTHER||||||=|0.0028||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0028
91643180|NCT03722849|183178757|OTHER||||||=|0.007||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0070
91643181|NCT03722849|183178758|OTHER|Group comparisons (Cough versus healthy) for each measurement using repeated measures ANOVA.|||||=|0.0019|||||||ANOVA|with repeated measures||||||=0.0019
91770605|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.28|-0.80|<0.0001
91643182|NCT03722849|183178760|OTHER|Group-wise comparisons using unpaired t-tests or one way ANOVA|||||<|0.0001|||||||ANOVA|||||||<0.0001
91643183|NCT03993288|183178761|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean value calculated by the least squares method did not exceed the predetermined boundary of non-inferiority of 5 g/L|Mean Difference (Net)|-0.24||||0.0032|TWO_SIDED|95.0|-4.86|4.38|||ANCOVA|||||4.38|-4.86|0.0032
91643184|NCT03533608|183178776|OTHER|Descriptive|Mean Difference (Final Values)|19.51|||||TWO_SIDED|||||||||||||
91643185|NCT03533608|183178777|OTHER|Descriptive|Mean Difference (Final Values)|4.04|||||TWO_SIDED|||||||||||||
91643186|NCT00915473|183178778|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
91643187|NCT00915473|183178779|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||Severe Migraine Frequency||||0.52
91643188|NCT00915473|183178779|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||At least Moderate Migraine Frequency||||0.52
91643189|NCT00915473|183178779|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||At Least Mild Migraine Frequency||||0.47
91643190|NCT00915473|183178780|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
91643191|NCT00915473|183178781|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
91643192|NCT01389024|183178782|SUPERIORITY||Incidence rate ratio|0.216||||0.2914|TWO_SIDED|90.0|0.009|1.66|||Poisson Regression||We calculated confidence intervals from exact Poisson regression.|||1.66|.009|0.2914
91643193|NCT00529802|183178794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.69|TWO_SIDED|95.0|-9.3|13.23|||t-test, 2 sided|Relative changes in tumor size were log-transformed to satisfy the normality assumption for the t-test.|Mean difference is the difference between Low and High SUV uptake groups in tumor size percent (%) change from baseline, and is reported on the raw scale. Tumor size changes were log-transformed for the t-test.|Relative changes in tumor size were log-transformed to satisfy the normality assumption.||13.23|-9.3|0.69
91643194|NCT00529802|183178795|SUPERIORITY_OR_OTHER||Slope|0.0028|STANDARD_ERROR_OF_MEAN|0.00109||0.013|TWO_SIDED|95.0|0.00063|0.004997|||Regression, Linear|Tumor size change (outcome variable) was log-transformed to satisfy the normality assumption.|Outcome was log(tumor size at 8 weeks/tumor size at baseline), and the predictor was the early change in aveSUVmax \[(aveSUVmax at 2 weeks - aveSUVmax at baseline)/aveSUVmax at baseline\] x 100%.|The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.||0.004997|0.00063|0.013
91643195|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
91643196|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7||||||95.0|-4.8|3.3||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated||3.3|-4.8|
91643197|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
91643198|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-6.4|1.7||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated||1.7|-6.4|
91643199|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated||1.4|-1.4|
91770606|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.47|-1.00|<0.0001
91643200|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
91643201|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.1||||||95.0|-1.4|6.8||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated||6.8|-1.4|
91643202|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
91643203|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated||2.7|-1.7|
91643204|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.0||||||95.0|-8.0|2.5||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated||2.5|-8.0|
91643205|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-8.0||||||95.0|-14.9|-1.2||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||-1.2|-14.9|
91770607|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6761|TWO_SIDED|95.0|-0.32|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.21|-0.32|0.6761
91643206|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.4|-1.4|
91643207|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-3.7|9.2||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||9.2|-3.7|
91643208|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.5|1.5||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.5|-1.5|
91643209|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.8||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-3.1|
91770608|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0188|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.05|-0.57|0.0188
91770609|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.61|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.10|-0.61|0.0067
91643210|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
91643211|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-5.8|1.8||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-5.8|
91643212|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
91643213|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-7.6|3.0||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-7.6|
91643214|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.3||||||95.0|-11.4|2.6||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||2.6|-11.4|
91643215|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.3||||||95.0|-5.0|4.3||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||4.3|-5.0|
91643216|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.6|3.5||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.5|-3.6|
91770610|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0335|TWO_SIDED|95.0|-0.68|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.03|-0.68|0.0335
91643217|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.1|3.0||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-3.1|
91643218|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||1.9|-3.1|
91643219|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.9||||||95.0|-3.2|5.0||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||5.0|-3.2|
91643220|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-13.2|4.4||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.4|-13.2|
91643221|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.8||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||2.8|-1.7|
91643222|NCT00366678|183178801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.2||||||95.0|-3.1|4.5||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.5|-3.1|
91643223|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
91643224|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.9||||||95.0|-0.9|4.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.9|-0.9|
91643225|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
91770611|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.91|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.25|-0.91|0.0007
91770612|NCT03192176|183427576|SUPERIORITY||LSMean differencce|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.48|-1.14|<0.0001
91643226|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
91643227|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|1.4||||||95.0|-1.1|5.9||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.9|-1.1|
91643228|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-5.8|2.7||||||For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.7|-5.8|
91643229|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
91643230|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.8|3.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||3.3|-1.8|
91643231|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.3|3.0||||||For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.0|-3.3|
91643232|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-0.4||||||95.0|-2.5|2.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.4|-2.5|
91643233|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.8|4.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.8|
91643234|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
91643235|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
91643236|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|-1.1|5.7||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.7|-1.1|
91643237|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.5|2.8||||||For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.8|-5.5|
91643238|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.2||||||95.0|-3.1|4.7||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.7|-3.1|
91643239|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-2.9|5.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.4|-2.9|
91643240|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-0.3||||||95.0|-5.5|4.4||||||For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.4|-5.5|
91770613|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.41|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.74|-1.41|<0.0001
91770614|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3227|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.17|-0.50|0.3227
91770615|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0085|TWO_SIDED|95.0|-0.77|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.11|-0.77|0.0085
91643241|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.9||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.9|-1.8|
91643242|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.9|4.4||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.9|
91643243|NCT00366678|183178802|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-4.1|3.7||||||For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.7|-4.1|
91643244|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.73|1.03||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.73|
91643245|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.67|1.03||||||For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.67|
91643246|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|1.04||||||95.0|0.86|1.26||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.26|0.86|
91643247|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.77|1.13||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.13|0.77|
91643248|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|1.07||||||95.0|0.82|1.4||||||For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.40|0.82|
91643249|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.69|1.1||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.10|0.69|
91643250|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.8||||||95.0|0.68|0.94||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.94|0.68|
91643251|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.71||||||95.0|0.59|0.85||||||For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.85|0.59|
91643252|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.95|1.33||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.33|0.95|
91643253|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.88||||||95.0|0.73|1.06||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.06|0.73|
91643254|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.72||||||95.0|0.58|0.9||||||For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.90|0.58|
91643255|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|1.22||||||95.0|1.0|1.49||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.49|1.00|
91643256|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.69|0.97||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.97|0.69|
91770616|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.95|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.30|-0.95|0.0002
91770617|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0102|TWO_SIDED|95.0|-0.87|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.12|-0.87|0.0102
91770618|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.15|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.39|-1.15|<0.0001
91643257|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.69|1.08||||||For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.08|0.69|
91643258|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.78|1.15||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.15|0.78|
91643259|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|1.26||||||95.0|1.0|1.59||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.59|1.00|
91770619|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.54|-1.29|<0.0001
91770620|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.46|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.68|-1.46|<0.0001
91770621|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.074|TWO_SIDED|95.0|-0.73|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.03|-0.73|0.0740
91770622|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0024|TWO_SIDED|95.0|-0.97|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.21|-0.97|0.0024
91770623|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.17|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.41|-1.17|<0.0001
91643260|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.91||||||95.0|0.68|1.2||||||For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.20|0.68|
91643261|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|1.39||||||95.0|1.08|1.79||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.79|1.08|
91643262|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.81||||||95.0|0.67|1.0||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.00|0.67|
91643263|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.85||||||95.0|0.67|1.07||||||For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.07|0.67|
91770624|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1197|TWO_SIDED|95.0|-0.72|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.08|-0.72|0.1197
91770625|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0046|TWO_SIDED|95.0|-0.98|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.18|-0.98|0.0046
91770626|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.28|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.47|-1.28|<0.0001
91770627|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.51|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.69|-1.51|<0.0001
91770628|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0553|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.01|-0.80|0.0553
91770629|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0823|TWO_SIDED|95.0|-0.76|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.76|0.0823
91770630|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.006|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.96|0.0060
91770631|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0374|TWO_SIDED|95.0|-0.83|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.03|-0.83|0.0374
91770632|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0042|TWO_SIDED|95.0|-1.0|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.19|-1.00|0.0042
91770633|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.56|-1.38|<0.0001
91770634|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.54|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.54|<0.0001
91770635|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.071|TWO_SIDED|95.0|-0.79|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.03|-0.79|0.0710
91770636|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.91|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.09|-0.91|0.0160
91770637|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0003|TWO_SIDED|95.0|-1.15|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.34|-1.15|0.0003
91770638|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1013|TWO_SIDED|95.0|-0.76|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.07|-0.76|0.1013
91770639|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0011|TWO_SIDED|95.0|-1.11|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.28|-1.11|0.0011
91770640|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.53|-1.36|<0.0001
91770641|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.57|-0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.72|-1.57|<0.0001
91770642|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0476|TWO_SIDED|95.0|-0.85|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.00|-0.85|0.0476
91770643|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.9|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.07|-0.90|0.0220
91770644|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0019|TWO_SIDED|95.0|-1.07|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.24|-1.07|0.0019
91770645|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1457|TWO_SIDED|95.0|-0.74|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.74|0.1457
91770646|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0284|TWO_SIDED|95.0|-0.91|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.05|-0.91|0.0284
91770647|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.26|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.39|-1.26|0.0002
91770648|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.36|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.48|-1.36|<0.0001
91770649|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4223|TWO_SIDED|95.0|-0.61|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.26|-0.61|0.4223
91770650|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0442|TWO_SIDED|95.0|-0.87|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.01|-0.87|0.0442
91770651|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0071|TWO_SIDED|95.0|-1.02|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-1.02|0.0071
91770652|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0823|TWO_SIDED|95.0|-0.8|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.05|-0.80|0.0823
91770653|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0336|TWO_SIDED|95.0|-0.89|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.04|-0.89|0.0336
91770654|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.32|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.46|-1.32|<0.0001
91770655|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.47|-1.34|<0.0001
91770656|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4819|TWO_SIDED|95.0|-0.59|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.59|0.4819
91770657|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0371|TWO_SIDED|95.0|-0.88|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.03|-0.88|0.0371
91770658|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0121|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.12|-0.97|0.0121
91770659|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0281|TWO_SIDED|95.0|-0.89|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.05|-0.89|0.0281
91770660|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0436|TWO_SIDED|95.0|-0.86|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.01|-0.86|0.0436
91770661|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-1.34|<0.0001
91770662|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.60|-1.47|<0.0001
91770663|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1488|TWO_SIDED|95.0|-0.75|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.11|-0.75|0.1488
91770664|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0251|TWO_SIDED|95.0|-0.91|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.06|-0.91|0.0251
91770665|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0027|TWO_SIDED|95.0|-1.08|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.23|-1.08|0.0027
91770666|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1053|TWO_SIDED|95.0|-0.77|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.07|-0.77|0.1053
91770667|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0304|TWO_SIDED|95.0|-0.9|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.04|-0.90|0.0304
91770668|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.43|-1.33|<0.0001
91643264|NCT00366678|183178803|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.78|1.19||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.19|0.78|
91770669|NCT03192176|183427576|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.49|-0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.61|-1.49|<0.0001
91770670|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0873|TWO_SIDED|95.0|-0.81|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.06|-0.81|0.0873
91770671|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0124|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.12|-0.97|0.0124
91770672|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0014|TWO_SIDED|95.0|-1.12|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.27|-1.12|0.0014
91770673|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0479|TWO_SIDED|95.0|-0.68|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.68|0.0479
91770674|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2342|TWO_SIDED|95.0|-0.54|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.13|-0.54|0.2342
91770675|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.84|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.84|0.0070
91770676|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4291|TWO_SIDED|95.0|-0.49|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.21|-0.49|0.4291
91770677|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0076|TWO_SIDED|95.0|-0.83|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.83|0.0076
91770678|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1506|TWO_SIDED|95.0|-0.62|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.10|-0.62|0.1506
91770679|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.5479|TWO_SIDED|95.0|-0.44|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.24|-0.44|0.5479
91770680|NCT03192176|183427576|SUPERIORITY||LSMean differencce|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.1427|TWO_SIDED|95.0|-0.57|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.57|0.1427
91770681|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1498|TWO_SIDED|95.0|-0.56|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-0.56|0.1498
91770682|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0103|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0103
91770683|NCT03192176|183427576|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8984|TWO_SIDED|95.0|-0.36|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.32|-0.36|0.8984
91770684|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0095|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0095
91770685|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.137|TWO_SIDED|95.0|-0.6|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.60|0.1370
91770686|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4223|TWO_SIDED|95.0|-0.46|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.19|-0.46|0.4223
91770687|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3265|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.50|0.3265
91770688|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0852|TWO_SIDED|95.0|-0.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.04|-0.62|0.0852
91770689|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0021|TWO_SIDED|95.0|-0.91|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.21|-0.91|0.0021
91770690|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5717|TWO_SIDED|95.0|-0.45|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.25|-0.45|0.5717
91770691|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0084|TWO_SIDED|95.0|-0.82|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.82|0.0084
91770692|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.04|-0.75|0.0277
91770693|NCT03192176|183427576|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4627|TWO_SIDED|95.0|-0.46|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.21|-0.46|0.4627
91770694|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0142|TWO_SIDED|95.0|-8.62|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.97|-8.62|0.0142
91770695|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-11.73|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.05|-11.73|<0.0001
91770696|NCT03192176|183427577|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.98|-5.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.31|-12.98|<0.0001
91770697|NCT03192176|183427577|SUPERIORITY||LSMean difference|-10.5|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-14.39|-6.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.61|-14.39|<0.0001
91770698|NCT03192176|183427577|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.98||0.0819|TWO_SIDED|95.0|-7.36|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.44|-7.36|0.0819
91770699|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.78|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.09|-10.78|0.0004
91770700|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.94||0.0005|TWO_SIDED|95.0|-10.69|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.05|-10.69|0.0005
91770701|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|1.98||0.038|TWO_SIDED|95.0|-8.01|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.23|-8.01|0.0380
91770702|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.99||0.0002|TWO_SIDED|95.0|-11.46|-3.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-3.64|-11.46|0.0002
91770703|NCT03192176|183427577|SUPERIORITY||LSMean differencce|-8.1|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-11.96|-4.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.17|-11.96|<0.0001
91770704|NCT03192176|183427577|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-13.17|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.25|-13.17|<0.0001
91770705|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.02||0.0245|TWO_SIDED|95.0|-8.52|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-8.52|0.0245
91770706|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.99||0.0031|TWO_SIDED|95.0|-9.83|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.01|-9.83|0.0031
91770707|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.98||0.0046|TWO_SIDED|95.0|-9.53|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.75|-9.53|0.0046
91770708|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.0064|TWO_SIDED|95.0|-9.61|-1.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.59|-9.61|0.0064
91770709|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.7|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.72|-4.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.65|-12.72|<0.0001
91770710|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.78|-4.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.75|-12.78|<0.0001
91770711|NCT03192176|183427577|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.27|-6.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.09|-14.27|<0.0001
91770712|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.08||0.0021|TWO_SIDED|95.0|-10.54|-2.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.36|-10.54|0.0021
91770713|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|2.05||0.0002|TWO_SIDED|95.0|-11.71|-3.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-3.66|-11.71|0.0002
91770714|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.04||0.0007|TWO_SIDED|95.0|-10.96|-2.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.95|-10.96|0.0007
91770715|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.03||0.0075|TWO_SIDED|95.0|-9.46|-1.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.47|-9.46|0.0075
91770716|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.44|-4.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.42|-12.44|<0.0001
91770717|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-12.15|-4.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.16|-12.15|<0.0001
91770718|NCT03192176|183427577|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.3|-6.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-6.16|-14.30|<0.0001
91770719|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.06||0.0021|TWO_SIDED|95.0|-10.46|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.34|-10.46|0.0021
91770720|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-12.25|-4.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.25|-12.25|<0.0001
91770721|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.02||0.0002|TWO_SIDED|95.0|-11.58|-3.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.62|-11.58|0.0002
91770722|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.92||0.0123|TWO_SIDED|95.0|-8.6|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.05|-8.60|0.0123
91770723|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.63|-4.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.07|-11.63|<0.0001
91770724|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.8|-4.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.23|-11.80|<0.0001
91770725|NCT03192176|183427577|SUPERIORITY||LSMean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-13.73|-6.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-6.03|-13.73|<0.0001
91770726|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.95||0.0013|TWO_SIDED|95.0|-10.13|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.47|-10.13|0.0013
91518610|NCT01570829|182911573|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
91770727|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.97|-3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.41|-10.97|0.0002
91770728|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.41|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.89|-10.41|0.0006
91770729|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0119|TWO_SIDED|95.0|-8.54|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.07|-8.54|0.0119
91770730|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.9||0.0004|TWO_SIDED|95.0|-10.58|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.09|-10.58|0.0004
91770731|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-11.57|-4.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-4.06|-11.57|<0.0001
91770732|NCT03192176|183427577|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-12.89|-5.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.27|-12.89|<0.0001
91770733|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.18|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.58|-9.18|0.0057
91770734|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.4|-2.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.90|-10.40|0.0006
91770735|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.89||0.0006|TWO_SIDED|95.0|-10.27|-2.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.81|-10.27|0.0006
91770736|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.93||0.021|TWO_SIDED|95.0|-8.27|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.68|-8.27|0.0210
91770737|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.93||0.0002|TWO_SIDED|95.0|-10.98|-3.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.38|-10.98|0.0002
91770738|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.3|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.12|-3.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.49|-11.12|0.0002
91770739|NCT03192176|183427577|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.99|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-5.25|-12.99|<0.0001
91770740|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.96||0.0047|TWO_SIDED|95.0|-9.45|-1.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.73|-9.45|0.0047
91770741|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.29|-2.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.67|-10.29|0.0009
91770742|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.92||0.0008|TWO_SIDED|95.0|-10.28|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.71|-10.28|0.0008
91770743|NCT03192176|183427577|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.93||0.0889|TWO_SIDED|95.0|-7.1|0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.51|-7.10|0.0889
91770744|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.94||0.0023|TWO_SIDED|95.0|-9.76|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.13|-9.76|0.0023
91770745|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.36|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.71|-10.36|0.0009
91770746|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.98||0.0002|TWO_SIDED|95.0|-11.36|-3.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.58|-11.36|0.0002
91770747|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.97||0.0255|TWO_SIDED|95.0|-8.3|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-8.30|0.0255
91770748|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.0031|TWO_SIDED|95.0|-9.63|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.98|-9.63|0.0031
91770749|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|1.93||0.0037|TWO_SIDED|95.0|-9.45|-1.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.85|-9.45|0.0037
91770750|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.84||0.0316|TWO_SIDED|95.0|-7.59|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.35|-7.59|0.0316
91770751|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.84||0.0036|TWO_SIDED|95.0|-9.02|-1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.78|-9.02|0.0036
91770752|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.85||0.0004|TWO_SIDED|95.0|-10.23|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.94|-10.23|0.0004
91770753|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.88||0.0001|TWO_SIDED|95.0|-10.93|-3.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.54|-10.93|0.0001
91643265|NCT00366678|183178806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.66|0.9||||||For Diphtheria the GMC ratio was calculated||0.90|0.66|
91770754|NCT03192176|183427577|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.0502|TWO_SIDED|95.0|-7.37|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.00|-7.37|0.0502
91770755|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0025|TWO_SIDED|95.0|-9.28|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.99|-9.28|0.0025
91770756|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.84||0.0063|TWO_SIDED|95.0|-8.67|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.44|-8.67|0.0063
91770757|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0117|TWO_SIDED|95.0|-8.58|-1.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.08|-8.58|0.0117
91770758|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.91||0.0047|TWO_SIDED|95.0|-9.17|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.67|-9.17|0.0047
91770759|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.92||0.0003|TWO_SIDED|95.0|-10.8|-3.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.23|-10.80|0.0003
91770760|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-11.51|-3.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.86|-11.51|<0.0001
91770761|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.94||0.0083|TWO_SIDED|95.0|-8.97|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.34|-8.97|0.0083
91770762|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.92||0.0011|TWO_SIDED|95.0|-10.1|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.56|-10.10|0.0011
91770763|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.9||0.0017|TWO_SIDED|95.0|-9.77|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.29|-9.77|0.0017
91770764|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.86||0.0119|TWO_SIDED|95.0|-8.37|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.05|-8.37|0.0119
91770765|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.29|-9.61|0.0015
91770766|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.38|-3.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.99|-11.38|<0.0001
91770767|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-11.33|-3.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.87|-11.33|<0.0001
91770768|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.89||0.0051|TWO_SIDED|95.0|-9.07|-1.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.62|-9.07|0.0051
91770769|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.87||0.0004|TWO_SIDED|95.0|-10.33|-2.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.96|-10.33|0.0004
91770770|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0014|TWO_SIDED|95.0|-9.64|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.34|-9.64|0.0014
91770771|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.82||0.0054|TWO_SIDED|95.0|-8.67|-1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.51|-8.67|0.0054
91770772|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.55|-9.71|0.0008
91770773|NCT03192176|183427577|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.2|-3.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.97|-11.20|<0.0001
91770774|NCT03192176|183427577|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-11.88|-4.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.59|-11.88|<0.0001
91770775|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0026|TWO_SIDED|95.0|-9.27|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.99|-9.27|0.0026
91770776|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.83||0.0003|TWO_SIDED|95.0|-10.35|-3.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.16|-10.35|0.0003
91770777|NCT03192176|183427577|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.81||0.0006|TWO_SIDED|95.0|-9.88|-2.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.75|-9.88|0.0006
91770778|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.12||0.0126|TWO_SIDED|95.0|-9.48|-1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.15|-9.48|0.0126
91770779|NCT03192176|183427577|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|2.12||0.1724|TWO_SIDED|95.0|-7.06|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.27|-7.06|0.1724
91770780|NCT03192176|183427577|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.18||0.3548|TWO_SIDED|95.0|-6.31|2.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||2.27|-6.31|0.3548
91770781|NCT03192176|183427577|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.18||0.086|TWO_SIDED|95.0|-8.04|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.53|-8.04|0.0860
91770782|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.19||0.0111|TWO_SIDED|95.0|-9.89|-1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.28|-9.89|0.0111
91770783|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.19||0.0349|TWO_SIDED|95.0|-8.94|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.33|-8.94|0.0349
91770784|NCT03192176|183427577|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.12||0.2205|TWO_SIDED|95.0|-6.77|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.57|-6.77|0.2205
91770785|NCT03192176|183427577|SUPERIORITY||LSMean differencce|-4.0|STANDARD_ERROR_OF_MEAN|2.17||0.0645|TWO_SIDED|95.0|-8.29|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.24|-8.29|0.0645
91770786|NCT03192176|183427577|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.16||0.5031|TWO_SIDED|95.0|-5.69|2.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.80|-5.69|0.5031
91770787|NCT03192176|183427577|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.24||0.5263|TWO_SIDED|95.0|-5.84|2.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.99|-5.84|0.5263
91770788|NCT03192176|183427577|SUPERIORITY||LSMean differencce|-2.4|STANDARD_ERROR_OF_MEAN|2.24||0.2782|TWO_SIDED|95.0|-6.83|1.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.97|-6.83|0.2782
91643266|NCT00366678|183178806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.82|
91770789|NCT03192176|183427577|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.24||0.0198|TWO_SIDED|95.0|-9.67|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.84|-9.67|0.0198
91770790|NCT03192176|183427577|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.25||0.0417|TWO_SIDED|95.0|-9.05|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.18|-9.05|0.0417
91770791|NCT03192176|183427577|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.16||0.2963|TWO_SIDED|95.0|-6.52|2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.00|-6.52|0.2963
91770792|NCT03192176|183427577|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|2.09||0.5408|TWO_SIDED|95.0|-5.39|2.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.83|-5.39|0.5408
91770793|NCT03192176|183427577|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.07||0.7473|TWO_SIDED|95.0|-4.74|3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.41|-4.74|0.7473
91706174|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|28.57||||0.0442|TWO_SIDED|90.0|0.91|53.07|||Barnard-Exact test|||Day 14||53.07|0.91|0.0442
91770794|NCT03192176|183427577|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|2.18||0.9214|TWO_SIDED|95.0|-4.07|4.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.50|-4.07|0.9214
91770795|NCT03192176|183427577|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.14||0.9876|TWO_SIDED|95.0|-4.19|4.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.26|-4.19|0.9876
91770796|NCT03192176|183427577|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.18||0.2379|TWO_SIDED|95.0|-6.86|1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.71|-6.86|0.2379
91770797|NCT03192176|183427577|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|2.18||0.1491|TWO_SIDED|95.0|-7.45|1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.14|-7.45|0.1491
91770798|NCT03192176|183427577|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|2.07||0.956|TWO_SIDED|95.0|-3.96|4.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.19|-3.96|0.9560
91770799|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.96||0.0089|TWO_SIDED|95.0|-9.01|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.30|-9.01|0.0089
91770800|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.22|-4.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.48|-12.22|<0.0001
91770801|NCT03192176|183427578|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.06|-5.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.34|-13.06|<0.0001
91770802|NCT03192176|183427578|SUPERIORITY||LSMean difference|-10.7|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-14.58|-6.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.75|-14.58|<0.0001
91770803|NCT03192176|183427578|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|2.0||0.063|TWO_SIDED|95.0|-7.65|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.20|-7.65|0.0630
91643267|NCT00366678|183178806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.8||||||95.0|0.67|0.97||||||For Diphtheria the GMC ratio was calculated||0.97|0.67|
91770804|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.04|-3.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.30|-11.04|0.0003
91770805|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.96||0.0007|TWO_SIDED|95.0|-10.53|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.84|-10.53|0.0007
91770806|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0231|TWO_SIDED|95.0|-8.43|-0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.63|-8.43|0.0231
91770807|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.94|-4.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.09|-11.94|<0.0001
91770808|NCT03192176|183427578|SUPERIORITY||LSMean differencce|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.87|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.05|-11.87|<0.0001
91770809|NCT03192176|183427578|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-13.21|-5.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.26|-13.21|<0.0001
91706175|NCT00938587|183306677|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.9||||0.3813|TWO_SIDED|90.0|-19.82|32.92|||Barnard-Exact test|||Day 14||32.92|-19.82|0.3813
91770810|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|2.02||0.0177|TWO_SIDED|95.0|-8.8|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.84|-8.80|0.0177
91770811|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.99||0.0012|TWO_SIDED|95.0|-10.45|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.60|-10.45|0.0012
91770812|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0072|TWO_SIDED|95.0|-9.26|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.64|-9.26|0.0072
91770813|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.04||0.0044|TWO_SIDED|95.0|-9.86|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-9.86|0.0044
91770814|NCT03192176|183427578|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-13.27|-5.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-5.21|-13.27|<0.0001
91770815|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.6|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.57|-4.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.55|-12.57|<0.0001
91770816|NCT03192176|183427578|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.29|-6.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.11|-14.29|<0.0001
91770817|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.08||0.0009|TWO_SIDED|95.0|-11.04|-2.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.87|-11.04|0.0009
91770818|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.44|-4.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.39|-12.44|<0.0001
91770819|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0012|TWO_SIDED|95.0|-10.65|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.64|-10.65|0.0012
91770820|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.04||0.0053|TWO_SIDED|95.0|-9.72|-1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.71|-9.72|0.0053
91770821|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.77|-4.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.73|-12.77|<0.0001
91770822|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|2.04||0.0001|TWO_SIDED|95.0|-11.84|-3.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.84|-11.84|0.0001
91770823|NCT03192176|183427578|SUPERIORITY||LSMean difference|-10.0|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.12|-5.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-5.96|-14.12|<0.0001
91770824|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|2.07||0.001|TWO_SIDED|95.0|-10.92|-2.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.78|-10.92|0.0010
91770825|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.49|-4.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.46|-12.49|<0.0001
91770826|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.03||0.0005|TWO_SIDED|95.0|-11.12|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.13|-11.12|0.0005
91770827|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.15|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-9.15|0.0057
91770828|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-12.15|-4.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.56|-12.15|<0.0001
91770829|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.68|-4.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.08|-11.68|<0.0001
91770830|NCT03192176|183427578|SUPERIORITY||LSMean difference|-9.8|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.66|-5.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-5.93|-13.66|<0.0001
91770831|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.95||0.0007|TWO_SIDED|95.0|-10.54|-2.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.85|-10.54|0.0007
91770832|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.55|-3.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.95|-11.55|<0.0001
91770833|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.92||0.001|TWO_SIDED|95.0|-10.16|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.60|-10.16|0.0010
91770834|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.91||0.0064|TWO_SIDED|95.0|-8.99|-1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.48|-8.99|0.0064
91770835|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.94|-3.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.42|-10.94|0.0002
91770836|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.92||0.0001|TWO_SIDED|95.0|-11.29|-3.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.75|-11.29|0.0001
91770837|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.69|-5.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.03|-12.69|<0.0001
91770838|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.003|TWO_SIDED|95.0|-9.62|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.99|-9.62|0.0030
91770839|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.92|-3.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.37|-10.92|0.0002
91770840|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.9||0.0013|TWO_SIDED|95.0|-9.91|-2.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.42|-9.91|0.0013
91770841|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0137|TWO_SIDED|95.0|-8.61|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-8.61|0.0137
91770842|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.24|-3.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.60|-11.24|0.0002
91770843|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.79|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.13|-10.79|0.0004
91770844|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-12.74|-4.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-4.97|-12.74|<0.0001
91770845|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.97||0.0028|TWO_SIDED|95.0|-9.82|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.07|-9.82|0.0028
91770846|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.95||0.0006|TWO_SIDED|95.0|-10.6|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.94|-10.60|0.0006
91770847|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.93||0.002|TWO_SIDED|95.0|-9.82|-2.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.21|-9.82|0.0020
91770848|NCT03192176|183427578|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0588|TWO_SIDED|95.0|-7.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-7.46|0.0588
91770849|NCT03192176|183427578|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0018|TWO_SIDED|95.0|-9.9|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-9.90|0.0018
91770850|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.94||0.0017|TWO_SIDED|95.0|-9.98|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.34|-9.98|0.0017
91770851|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.09|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.32|-11.09|0.0003
91770852|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.97||0.081|TWO_SIDED|95.0|-8.55|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.81|-8.55|0.0810
91770853|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.94||0.002|TWO_SIDED|95.0|-9.88|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.23|-9.88|0.0020
91770854|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.93||0.0076|TWO_SIDED|95.0|-8.98|-1.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.39|-8.98|0.0076
91643268|NCT00366678|183178806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.69|
91643269|NCT00366678|183178807|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.73|1.14||||||For Hib (PRP) the GMC ratio was calculated||1.14|0.73|
91643270|NCT00366678|183178807|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.04||||||95.0|0.82|1.32||||||For Hib (PRP) the GMC ratio was calculated||1.32|0.82|
91770855|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.85||0.0182|TWO_SIDED|95.0|-8.01|-0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.75|-8.01|0.0182
91770856|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.84||0.0019|TWO_SIDED|95.0|-9.42|-2.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.16|-9.42|0.0019
91770857|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.02|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.71|-10.02|0.0007
91770858|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.88||0.0002|TWO_SIDED|95.0|-10.76|-3.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.35|-10.76|0.0002
91518611|NCT01570829|182911574|SUPERIORITY|||||||0.67||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with waist circumference data.||||0.67
91770859|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.88||0.0263|TWO_SIDED|95.0|-7.89|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.50|-7.89|0.0263
91770860|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.29|-9.61|0.0015
91770861|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.84||0.0113|TWO_SIDED|95.0|-8.32|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.07|-8.32|0.0113
91770862|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.91||0.0059|TWO_SIDED|95.0|-9.04|-1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.54|-9.04|0.0059
91770863|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.91||0.0018|TWO_SIDED|95.0|-9.76|-2.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.25|-9.76|0.0018
91770864|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.93||0.0004|TWO_SIDED|95.0|-10.62|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.05|-10.62|0.0004
91770865|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.95||0.0001|TWO_SIDED|95.0|-11.39|-3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.73|-11.39|0.0001
91770866|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.94||0.0044|TWO_SIDED|95.0|-9.4|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.75|-9.40|0.0044
91770867|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.92||0.0006|TWO_SIDED|95.0|-10.4|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.84|-10.40|0.0006
91643271|NCT00366678|183178808|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.71|1.09||||||For Polio Type 1 the GMC ratio was calculated||1.09|0.71|
91770868|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.91||0.0025|TWO_SIDED|95.0|-9.57|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.07|-9.57|0.0025
91643272|NCT00366678|183178808|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.66|1.03||||||For Polio Type 2 the GMC ratio was calculated||1.03|0.66|
91770869|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.86||0.0059|TWO_SIDED|95.0|-8.81|-1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.49|-8.81|0.0059
91770870|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.06|-2.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.74|-10.06|0.0007
91770871|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.18|-3.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.79|-11.18|<0.0001
91770872|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.9||0.0001|TWO_SIDED|95.0|-11.18|-3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.72|-11.18|0.0001
91706176|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1017|TWO_SIDED|90.0|-3.9|27.09|||Barnard exact test|||Day 7||27.09|-3.90|0.1017
91770873|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.89||0.0022|TWO_SIDED|95.0|-9.56|-2.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.11|-9.56|0.0022
91770874|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.87||0.0003|TWO_SIDED|95.0|-10.56|-3.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.19|-10.56|0.0003
91770875|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.44|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.13|-9.44|0.0020
91770876|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.82||0.0023|TWO_SIDED|95.0|-9.18|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.01|-9.18|0.0023
91770877|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.82||0.0004|TWO_SIDED|95.0|-10.06|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.89|-10.06|0.0004
91770878|NCT03192176|183427578|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.05|-3.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.81|-11.05|<0.0001
91770879|NCT03192176|183427578|SUPERIORITY||LSMean difference|-8.1|STANDARD_ERROR_OF_MEAN|1.86|<|0.0001|TWO_SIDED|95.0|-11.8|-4.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.49|-11.80|<0.0001
91770880|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.85||0.0011|TWO_SIDED|95.0|-9.77|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.47|-9.77|0.0011
91770881|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|TWO_SIDED|95.0|-10.54|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.32|-10.54|0.0002
91770882|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.56|-9.71|0.0008
91770883|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|2.15||0.0054|TWO_SIDED|95.0|-10.26|-1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.80|-10.26|0.0054
91770884|NCT03192176|183427578|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.15||0.1145|TWO_SIDED|95.0|-7.63|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.83|-7.63|0.1145
91770885|NCT03192176|183427578|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.21||0.2106|TWO_SIDED|95.0|-7.13|1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.58|-7.13|0.2106
91770886|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.21||0.0685|TWO_SIDED|95.0|-8.39|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.31|-8.39|0.0685
91770887|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.22||0.0029|TWO_SIDED|95.0|-11.02|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-2.29|-11.02|0.0029
91770888|NCT03192176|183427578|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.22||0.0239|TWO_SIDED|95.0|-9.42|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.67|-9.42|0.0239
91770889|NCT03192176|183427578|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.15||0.2224|TWO_SIDED|95.0|-6.86|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.60|-6.86|0.2224
91770890|NCT03192176|183427578|SUPERIORITY||LSMean differencce|-4.8|STANDARD_ERROR_OF_MEAN|2.22||0.0308|TWO_SIDED|95.0|-9.17|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.45|-9.17|0.0308
91770891|NCT03192176|183427578|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|2.21||0.4194|TWO_SIDED|95.0|-6.13|2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.56|-6.13|0.4194
91770892|NCT03192176|183427578|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3759|TWO_SIDED|95.0|-6.55|2.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.48|-6.55|0.3759
91770893|NCT03192176|183427578|SUPERIORITY||LSMean differencce|-2.8|STANDARD_ERROR_OF_MEAN|2.29||0.2285|TWO_SIDED|95.0|-7.26|1.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.74|-7.26|0.2285
91770894|NCT03192176|183427578|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|2.29||0.0072|TWO_SIDED|95.0|-10.71|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-1.70|-10.71|0.0072
91770895|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.31||0.0338|TWO_SIDED|95.0|-9.46|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.38|-9.46|0.0338
91770896|NCT03192176|183427578|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.21||0.3026|TWO_SIDED|95.0|-6.64|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.07|-6.64|0.3026
91770897|NCT03192176|183427578|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.16||0.312|TWO_SIDED|95.0|-6.45|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.07|-6.45|0.3120
91770898|NCT03192176|183427578|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.15||0.6816|TWO_SIDED|95.0|-5.11|3.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.34|-5.11|0.6816
91770899|NCT03192176|183427578|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|2.26||0.8599|TWO_SIDED|95.0|-4.85|4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.05|-4.85|0.8599
91770900|NCT03192176|183427578|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.23||0.9093|TWO_SIDED|95.0|-4.64|4.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.13|-4.64|0.9093
91770901|NCT03192176|183427578|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.26||0.0788|TWO_SIDED|95.0|-8.43|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.46|-8.43|0.0788
91770902|NCT03192176|183427578|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.26||0.1278|TWO_SIDED|95.0|-7.92|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.00|-7.92|0.1278
91770903|NCT03192176|183427578|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.15||0.9848|TWO_SIDED|95.0|-4.19|4.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.27|-4.19|0.9848
91770904|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|7.05||0.0388|TWO_SIDED|95.0|0.76|28.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||28.49|0.76|0.0388
91770905|NCT03192176|183427579|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.08||0.0012|TWO_SIDED|95.0|9.17|37.02||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||37.02|9.17|0.0012
91770906|NCT03192176|183427579|SUPERIORITY||LSMean difference|37.3|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|23.41|51.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||51.22|23.41|<0.0001
91770907|NCT03192176|183427579|SUPERIORITY||LSMean difference|41.0|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|26.88|55.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||55.05|26.88|<0.0001
91643273|NCT00366678|183178808|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.59|1.02||||||For Polio Type 3 the GMC ratio was calculated||1.02|0.59|
91770908|NCT03192176|183427579|SUPERIORITY||LSMean difference|8.2|STANDARD_ERROR_OF_MEAN|7.19||0.2569|TWO_SIDED|95.0|-5.98|22.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||22.32|-5.98|0.2569
91770909|NCT03192176|183427579|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.07||0.0003|TWO_SIDED|95.0|11.65|39.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||39.47|11.65|0.0003
91770910|NCT03192176|183427579|SUPERIORITY||LSMean difference|30.2|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|16.39|44.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||44.06|16.39|<0.0001
91770911|NCT03192176|183427579|SUPERIORITY||LSMean difference|15.9|STANDARD_ERROR_OF_MEAN|7.02||0.024|TWO_SIDED|95.0|2.11|29.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||29.71|2.11|0.0240
91770912|NCT03192176|183427579|SUPERIORITY||LSMean difference|24.5|STANDARD_ERROR_OF_MEAN|7.05||0.0006|TWO_SIDED|95.0|10.62|38.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.37|10.62|0.0006
91770913|NCT03192176|183427579|SUPERIORITY||LSMean differencce|33.7|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|19.87|47.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.52|19.87|<0.0001
91770914|NCT03192176|183427579|SUPERIORITY||LSMean difference|38.0|STANDARD_ERROR_OF_MEAN|7.15|<|0.0001|TWO_SIDED|95.0|23.93|52.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||52.04|23.93|<0.0001
91770915|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|7.16||0.0441|TWO_SIDED|95.0|0.38|28.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||28.53|0.38|0.0441
91770916|NCT03192176|183427579|SUPERIORITY||LSMean difference|19.4|STANDARD_ERROR_OF_MEAN|7.04||0.0061|TWO_SIDED|95.0|5.58|33.28||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.28|5.58|0.0061
91643274|NCT00366678|183178808|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.72|1.41||||||For Polio Type 1 the GMC ratio was calculated||1.41|0.72|
91643275|NCT00366678|183178808|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.72|1.34||||||For Polio Type 2 the GMC ratio was calculated||1.34|0.72|
91770917|NCT03192176|183427579|SUPERIORITY||LSMean difference|25.7|STANDARD_ERROR_OF_MEAN|7.01||0.0003|TWO_SIDED|95.0|11.96|39.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||39.53|11.96|0.0003
91770918|NCT03192176|183427579|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.55||0.0078|TWO_SIDED|95.0|5.36|35.07||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||35.07|5.36|0.0078
91770919|NCT03192176|183427579|SUPERIORITY||LSMean difference|28.3|STANDARD_ERROR_OF_MEAN|7.59||0.0002|TWO_SIDED|95.0|13.36|43.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.22|13.36|0.0002
91770920|NCT03192176|183427579|SUPERIORITY||LSMean difference|36.9|STANDARD_ERROR_OF_MEAN|7.55|<|0.0001|TWO_SIDED|95.0|22.07|51.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||51.77|22.07|<0.0001
91770921|NCT03192176|183427579|SUPERIORITY||LSMean difference|40.5|STANDARD_ERROR_OF_MEAN|7.69|<|0.0001|TWO_SIDED|95.0|25.41|55.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRm|||Week 3||55.67|25.41|<0.0001
91770922|NCT03192176|183427579|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.7||0.0108|TWO_SIDED|95.0|4.59|34.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||34.88|4.59|0.0108
91770923|NCT03192176|183427579|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|7.56||0.0011|TWO_SIDED|95.0|10.09|39.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||39.84|10.09|0.0011
91770924|NCT03192176|183427579|SUPERIORITY||LSMean difference|30.9|STANDARD_ERROR_OF_MEAN|7.53|<|0.0001|TWO_SIDED|95.0|16.03|45.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.67|16.03|<0.0001
91770925|NCT03192176|183427579|SUPERIORITY||LSMean difference|20.5|STANDARD_ERROR_OF_MEAN|7.47||0.0063|TWO_SIDED|95.0|5.84|35.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||35.23|5.84|0.0063
91770926|NCT03192176|183427579|SUPERIORITY||LSMean difference|28.7|STANDARD_ERROR_OF_MEAN|7.49||0.0002|TWO_SIDED|95.0|13.98|43.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.46|13.98|0.0002
91770927|NCT03192176|183427579|SUPERIORITY||LSMean difference|33.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|18.66|48.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||48.00|18.66|<0.0001
91770928|NCT03192176|183427579|SUPERIORITY||LSMean difference|41.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|26.52|56.41||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.41|26.52|<0.0001
91770929|NCT03192176|183427579|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.59||0.0098|TWO_SIDED|95.0|4.78|34.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||34.66|4.78|0.0098
91770930|NCT03192176|183427579|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|15.26|44.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||44.61|15.26|<0.0001
91770931|NCT03192176|183427579|SUPERIORITY||LSMean difference|33.1|STANDARD_ERROR_OF_MEAN|7.43|<|0.0001|TWO_SIDED|95.0|18.5|47.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||47.73|18.50|<0.0001
91770932|NCT03192176|183427579|SUPERIORITY||LSMean difference|15.4|STANDARD_ERROR_OF_MEAN|7.1||0.0303|TWO_SIDED|95.0|1.48|29.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||29.40|1.48|0.0303
91770933|NCT03192176|183427579|SUPERIORITY||LSMean difference|24.8|STANDARD_ERROR_OF_MEAN|7.11||0.0006|TWO_SIDED|95.0|10.77|38.74||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.74|10.77|0.0006
91770934|NCT03192176|183427579|SUPERIORITY||LSMean difference|30.8|STANDARD_ERROR_OF_MEAN|7.11|<|0.0001|TWO_SIDED|95.0|16.77|44.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.75|16.77|<0.0001
91770935|NCT03192176|183427579|SUPERIORITY||LSMean difference|38.8|STANDARD_ERROR_OF_MEAN|7.23|<|0.0001|TWO_SIDED|95.0|24.55|53.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||53.00|24.55|<0.0001
91770936|NCT03192176|183427579|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.2||0.0086|TWO_SIDED|95.0|4.88|33.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||33.23|4.88|0.0086
91770937|NCT03192176|183427579|SUPERIORITY||LSMean difference|22.3|STANDARD_ERROR_OF_MEAN|7.09||0.0018|TWO_SIDED|95.0|8.33|36.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||36.24|8.33|0.0018
91770938|NCT03192176|183427579|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|7.07||0.0004|TWO_SIDED|95.0|11.24|39.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||39.05|11.24|0.0004
91770939|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.62||0.0282|TWO_SIDED|95.0|1.56|27.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.60|1.56|0.0282
91770940|NCT03192176|183427579|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|6.63||0.0029|TWO_SIDED|95.0|6.85|32.92||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.92|6.85|0.0029
91770941|NCT03192176|183427579|SUPERIORITY||LSMean difference|29.7|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|16.58|42.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||42.73|16.58|<0.0001
91770942|NCT03192176|183427579|SUPERIORITY||LSMean difference|35.7|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.42|48.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.99|22.42|<0.0001
91770943|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.74||0.0304|TWO_SIDED|95.0|1.4|27.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.90|1.40|0.0304
91770944|NCT03192176|183427579|SUPERIORITY||LSMean difference|20.4|STANDARD_ERROR_OF_MEAN|6.64||0.0022|TWO_SIDED|95.0|7.38|33.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.50|7.38|0.0022
91770945|NCT03192176|183427579|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.59|<|0.0001|TWO_SIDED|95.0|13.56|39.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||39.50|13.56|<0.0001
91770946|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.4|STANDARD_ERROR_OF_MEAN|6.87||0.0362|TWO_SIDED|95.0|0.93|27.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||27.95|0.93|0.0362
91770947|NCT03192176|183427579|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.88||0.0009|TWO_SIDED|95.0|9.41|36.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.47|9.41|0.0009
91770948|NCT03192176|183427579|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|6.91|<|0.0001|TWO_SIDED|95.0|15.27|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||42.46|15.27|<0.0001
91770949|NCT03192176|183427579|SUPERIORITY||LSMean difference|36.8|STANDARD_ERROR_OF_MEAN|7.01|<|0.0001|TWO_SIDED|95.0|22.99|50.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||50.57|22.99|<0.0001
91770950|NCT03192176|183427579|SUPERIORITY||LSMean difference|15.6|STANDARD_ERROR_OF_MEAN|6.99||0.0265|TWO_SIDED|95.0|1.83|29.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||29.34|1.83|0.0265
91770951|NCT03192176|183427579|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.89||0.0023|TWO_SIDED|95.0|7.6|34.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.71|7.60|0.0023
91770952|NCT03192176|183427579|SUPERIORITY||LSMean difference|27.1|STANDARD_ERROR_OF_MEAN|6.85|<|0.0001|TWO_SIDED|95.0|13.64|40.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||40.59|13.64|<0.0001
91770953|NCT03192176|183427579|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|6.8||0.158|TWO_SIDED|95.0|-3.75|22.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||22.99|-3.75|0.1580
91770954|NCT03192176|183427579|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.8||0.0082|TWO_SIDED|95.0|4.72|31.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.50|4.72|0.0082
91770955|NCT03192176|183427579|SUPERIORITY||LSMean difference|25.2|STANDARD_ERROR_OF_MEAN|6.85||0.0003|TWO_SIDED|95.0|11.77|38.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||38.71|11.77|0.0003
91770956|NCT03192176|183427579|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|6.96|<|0.0001|TWO_SIDED|95.0|16.93|44.31||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||44.31|16.93|<0.0001
91770957|NCT03192176|183427579|SUPERIORITY||LSMean difference|11.2|STANDARD_ERROR_OF_MEAN|6.93||0.1074|TWO_SIDED|95.0|-2.45|24.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||24.84|-2.45|0.1074
91706177|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0218|TWO_SIDED|90.0|4.49|38.44|||Barnard exact test|||Day 7||38.44|4.49|0.0218
91770958|NCT03192176|183427579|SUPERIORITY||LSMean difference|18.3|STANDARD_ERROR_OF_MEAN|6.83||0.0077|TWO_SIDED|95.0|4.87|31.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.76|4.87|0.0077
91770959|NCT03192176|183427579|SUPERIORITY||LSMean difference|23.6|STANDARD_ERROR_OF_MEAN|6.79||0.0006|TWO_SIDED|95.0|10.29|37.01||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||37.01|10.29|0.0006
91770960|NCT03192176|183427579|SUPERIORITY||LSMean difference|11.8|STANDARD_ERROR_OF_MEAN|6.47||0.0689|TWO_SIDED|95.0|-0.92|24.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||24.53|-0.92|0.0689
91770961|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.46||0.025|TWO_SIDED|95.0|1.84|27.27||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||27.27|1.84|0.0250
91770962|NCT03192176|183427579|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.51||0.0002|TWO_SIDED|95.0|11.54|37.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||37.17|11.54|0.0002
91770963|NCT03192176|183427579|SUPERIORITY||LSMean difference|29.6|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|16.6|42.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.57|16.60|<0.0001
91770964|NCT03192176|183427579|SUPERIORITY||LSMean difference|8.4|STANDARD_ERROR_OF_MEAN|6.59||0.2041|TWO_SIDED|95.0|-4.58|21.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||21.36|-4.58|0.2041
91770965|NCT03192176|183427579|SUPERIORITY||LSMean difference|18.4|STANDARD_ERROR_OF_MEAN|6.5||0.0049|TWO_SIDED|95.0|5.62|31.2||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||31.20|5.62|0.0049
91770966|NCT03192176|183427579|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.45||0.0015|TWO_SIDED|95.0|8.0|33.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||33.37|8.00|0.0015
91770967|NCT03192176|183427579|SUPERIORITY||LSMean difference|15.8|STANDARD_ERROR_OF_MEAN|6.66||0.0184|TWO_SIDED|95.0|2.68|28.89||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||28.89|2.68|0.0184
91706178|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1082|TWO_SIDED|90.0|-3.71|27.06|||Barnard exact test|||Day 7||27.06|-3.71|0.1082
91770968|NCT03192176|183427579|SUPERIORITY||LSMean difference|12.8|STANDARD_ERROR_OF_MEAN|6.66||0.0551|TWO_SIDED|95.0|-0.28|25.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||25.93|-0.28|0.0551
91770969|NCT03192176|183427579|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.73||0.0002|TWO_SIDED|95.0|12.51|39.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||39.00|12.51|0.0002
91770970|NCT03192176|183427579|SUPERIORITY||LSMean difference|31.6|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|18.17|44.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||44.93|18.17|<0.0001
91770971|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|6.79||0.0367|TWO_SIDED|95.0|0.89|27.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||27.62|0.89|0.0367
91770972|NCT03192176|183427579|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.7||0.0017|TWO_SIDED|95.0|7.99|34.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||34.34|7.99|0.0017
91770973|NCT03192176|183427579|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.65||0.0003|TWO_SIDED|95.0|11.29|37.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.44|11.29|0.0003
91770974|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|6.45||0.0255|TWO_SIDED|95.0|1.78|27.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.15|1.78|0.0255
91518612|NCT01570829|182911574|SUPERIORITY|||||||0.26||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with hip circumference data.||||0.26
91770975|NCT03192176|183427579|SUPERIORITY||LSMean difference|15.3|STANDARD_ERROR_OF_MEAN|6.45||0.0186|TWO_SIDED|95.0|2.57|27.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.94|2.57|0.0186
91770976|NCT03192176|183427579|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.52|<|0.0001|TWO_SIDED|95.0|13.71|39.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||39.36|13.71|<0.0001
91770977|NCT03192176|183427579|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.94|42.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.81|16.94|<0.0001
91770978|NCT03192176|183427579|SUPERIORITY||LSMean difference|13.9|STANDARD_ERROR_OF_MEAN|6.57||0.0347|TWO_SIDED|95.0|1.01|26.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||26.85|1.01|0.0347
91770979|NCT03192176|183427579|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.48||0.0008|TWO_SIDED|95.0|9.16|34.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.65|9.16|0.0008
91770980|NCT03192176|183427579|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.43||0.0003|TWO_SIDED|95.0|10.75|36.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||36.04|10.75|0.0003
91770981|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.43||0.0221|TWO_SIDED|95.0|2.13|27.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.43|2.13|0.0221
91770982|NCT03192176|183427579|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|6.43||0.0087|TWO_SIDED|95.0|4.32|29.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||29.62|4.32|0.0087
91770983|NCT03192176|183427579|SUPERIORITY||LSMean difference|26.4|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|13.65|39.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||39.23|13.65|<0.0001
91770984|NCT03192176|183427579|SUPERIORITY||LSMean difference|31.0|STANDARD_ERROR_OF_MEAN|6.56|<|0.0001|TWO_SIDED|95.0|18.13|43.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||43.94|18.13|<0.0001
91770985|NCT03192176|183427579|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.55||0.0244|TWO_SIDED|95.0|1.92|27.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.70|1.92|0.0244
91770986|NCT03192176|183427579|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.46||0.0008|TWO_SIDED|95.0|9.21|34.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.62|9.21|0.0008
91770987|NCT03192176|183427579|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|6.41||0.0003|TWO_SIDED|95.0|10.63|35.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.83|10.63|0.0003
91770988|NCT03192176|183427579|SUPERIORITY||LSMean difference|9.8|STANDARD_ERROR_OF_MEAN|7.38||0.1871|TWO_SIDED|95.0|-4.77|24.3||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||24.30|-4.77|0.1871
91770989|NCT03192176|183427579|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|7.38||0.7552|TWO_SIDED|95.0|-12.23|16.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||16.83|-12.23|0.7552
91770990|NCT03192176|183427579|SUPERIORITY||LSMean difference|1.5|STANDARD_ERROR_OF_MEAN|7.61||0.8407|TWO_SIDED|95.0|-13.44|16.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||16.50|-13.44|0.8407
91770991|NCT03192176|183427579|SUPERIORITY||LSMean difference|7.2|STANDARD_ERROR_OF_MEAN|7.6||0.345|TWO_SIDED|95.0|-7.77|22.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||22.14|-7.77|0.3450
91770992|NCT03192176|183427579|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|7.66||0.455|TWO_SIDED|95.0|-9.34|20.8||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||20.80|-9.34|0.4550
91770993|NCT03192176|183427579|SUPERIORITY||LSMean difference|10.4|STANDARD_ERROR_OF_MEAN|7.64||0.1747|TWO_SIDED|95.0|-4.64|25.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||25.44|-4.64|0.1747
91770994|NCT03192176|183427579|SUPERIORITY||LSMean difference|4.4|STANDARD_ERROR_OF_MEAN|7.38||0.5476|TWO_SIDED|95.0|-10.08|18.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||18.97|-10.08|0.5476
91770995|NCT03192176|183427579|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|8.01||0.7954|TWO_SIDED|95.0|-13.69|17.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.84|-13.69|0.7954
91770996|NCT03192176|183427579|SUPERIORITY||LSMean differencce|1.3|STANDARD_ERROR_OF_MEAN|7.96||0.8731|TWO_SIDED|95.0|-14.41|16.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.95|-14.41|0.8731
91770997|NCT03192176|183427579|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|8.31||0.9689|TWO_SIDED|95.0|-16.68|16.03||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.03|-16.68|0.9689
91770998|NCT03192176|183427579|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|8.28||0.6378|TWO_SIDED|95.0|-12.4|20.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.21|-12.40|0.6378
91770999|NCT03192176|183427579|SUPERIORITY||LSMean differencce|1.6|STANDARD_ERROR_OF_MEAN|8.33||0.8503|TWO_SIDED|95.0|-14.82|17.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.97|-14.82|0.8503
91771000|NCT03192176|183427579|SUPERIORITY||LSMean difference|13.0|STANDARD_ERROR_OF_MEAN|8.37||0.1224|TWO_SIDED|95.0|-3.51|29.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||29.44|-3.51|0.1224
91771001|NCT03192176|183427579|SUPERIORITY||LSMean difference|7.1|STANDARD_ERROR_OF_MEAN|7.99||0.3743|TWO_SIDED|95.0|-8.62|22.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.85|-8.62|0.3743
91771002|NCT03192176|183427579|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|7.89||0.3173|TWO_SIDED|95.0|-23.44|7.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||7.63|-23.44|0.3173
91771003|NCT03192176|183427579|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.82||0.7905|TWO_SIDED|95.0|-17.48|13.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.32|-17.48|0.7905
91771004|NCT03192176|183427579|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|8.24||0.3804|TWO_SIDED|95.0|-23.46|8.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||8.98|-23.46|0.3804
91771005|NCT03192176|183427579|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|8.11||0.4905|TWO_SIDED|95.0|-21.58|10.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||10.38|-21.58|0.4905
91771006|NCT03192176|183427579|SUPERIORITY||LSMean difference|-12.6|STANDARD_ERROR_OF_MEAN|8.25||0.1289|TWO_SIDED|95.0|-28.83|3.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||3.68|-28.83|0.1289
91771007|NCT03192176|183427579|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|8.24||0.4398|TWO_SIDED|95.0|-9.86|22.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||22.61|-9.86|0.4398
91771008|NCT03192176|183427579|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.81||0.7921|TWO_SIDED|95.0|-17.45|13.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.33|-17.45|0.7921
91771009|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.28||0.009|TWO_SIDED|95.0|4.82|33.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||33.46|4.82|0.0090
91771010|NCT03192176|183427580|SUPERIORITY||LSMean difference|27.0|STANDARD_ERROR_OF_MEAN|7.32||0.0003|TWO_SIDED|95.0|12.61|41.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||41.39|12.61|0.0003
91771011|NCT03192176|183427580|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.31|<|0.0001|TWO_SIDED|95.0|25.14|53.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||53.90|25.14|<0.0001
91771012|NCT03192176|183427580|SUPERIORITY||LSMean difference|44.8|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|30.27|59.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||59.39|30.27|<0.0001
91771013|NCT03192176|183427580|SUPERIORITY||LSMean difference|12.2|STANDARD_ERROR_OF_MEAN|7.43||0.1019|TWO_SIDED|95.0|-2.43|26.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||26.79|-2.43|0.1019
91771014|NCT03192176|183427580|SUPERIORITY||LSMean difference|27.8|STANDARD_ERROR_OF_MEAN|7.31||0.0002|TWO_SIDED|95.0|13.45|42.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||42.22|13.45|0.0002
91771015|NCT03192176|183427580|SUPERIORITY||LSMean difference|29.5|STANDARD_ERROR_OF_MEAN|7.27|<|0.0001|TWO_SIDED|95.0|15.21|43.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||43.82|15.21|<0.0001
91771016|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|7.03||0.0049|TWO_SIDED|95.0|6.1|33.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.76|6.10|0.0049
91771017|NCT03192176|183427580|SUPERIORITY||LSMean difference|28.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|14.64|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||42.46|14.64|<0.0001
91771018|NCT03192176|183427580|SUPERIORITY||LSMean differencce|33.8|STANDARD_ERROR_OF_MEAN|7.05|<|0.0001|TWO_SIDED|95.0|19.96|47.69||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.69|19.96|<0.0001
91771019|NCT03192176|183427580|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|25.4|53.58||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||53.58|25.40|<0.0001
91771020|NCT03192176|183427580|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|7.17||0.0146|TWO_SIDED|95.0|3.5|31.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||31.70|3.50|0.0146
91771021|NCT03192176|183427580|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|7.06||0.0007|TWO_SIDED|95.0|10.21|38.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.00|10.21|0.0007
91643276|NCT00366678|183178808|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.84||||||95.0|0.6|1.17||||||For Polio Type 3 the GMC ratio was calculated||1.17|0.60|
91771022|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.9|STANDARD_ERROR_OF_MEAN|7.03||0.0008|TWO_SIDED|95.0|10.05|37.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||37.70|10.05|0.0008
91771023|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|7.46||0.002|TWO_SIDED|95.0|8.56|37.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||37.90|8.56|0.0020
91771024|NCT03192176|183427580|SUPERIORITY||LSMean difference|34.4|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|19.6|49.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||49.11|19.60|<0.0001
91771025|NCT03192176|183427580|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|20.96|50.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||50.32|20.96|<0.0001
91771026|NCT03192176|183427580|SUPERIORITY||LSMean difference|43.0|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|28.03|57.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||57.93|28.03|<0.0001
91771027|NCT03192176|183427580|SUPERIORITY||LSMean difference|25.4|STANDARD_ERROR_OF_MEAN|7.6||0.0009|TWO_SIDED|95.0|10.48|40.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||40.37|10.48|0.0009
91706179|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0166|TWO_SIDED|90.0|4.81|38.44|||Barnard exact test|||Day 7||38.44|4.81|0.0166
91771028|NCT03192176|183427580|SUPERIORITY||LSMean difference|31.2|STANDARD_ERROR_OF_MEAN|7.48|<|0.0001|TWO_SIDED|95.0|16.49|45.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.90|16.49|<0.0001
91771029|NCT03192176|183427580|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|7.44||0.0001|TWO_SIDED|95.0|14.24|43.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.52|14.24|0.0001
91771030|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.42||0.0021|TWO_SIDED|95.0|8.46|37.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||37.66|8.46|0.0021
91771031|NCT03192176|183427580|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|7.45|<|0.0001|TWO_SIDED|95.0|17.42|46.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||46.71|17.42|<0.0001
91771032|NCT03192176|183427580|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.73|45.91||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.91|16.73|<0.0001
91771033|NCT03192176|183427580|SUPERIORITY||LSMean difference|41.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED|95.0|26.95|56.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.68|26.95|<0.0001
91771034|NCT03192176|183427580|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.54||0.0008|TWO_SIDED|95.0|10.77|40.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||40.43|10.77|0.0008
91771035|NCT03192176|183427580|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.75|45.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.94|16.75|<0.0001
91771036|NCT03192176|183427580|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|7.39|<|0.0001|TWO_SIDED|95.0|14.91|43.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.97|14.91|<0.0001
91771037|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.05||0.0045|TWO_SIDED|95.0|6.31|34.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||34.06|6.31|0.0045
91643277|NCT00366678|183178809|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.78|0.98||||||For Pertussis - FHA the GMC ratio was calculated||0.98|0.78|
91643278|NCT00366678|183178809|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.92||||||95.0|0.84|1.02||||||For Pertussis - PT the GMC ratio was calculated||1.02|0.84|
91643279|NCT00366678|183178809|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.72|1.0||||||For Pertussis - FHA the GMC ratio was calculated||1.00|0.72|
91643280|NCT00366678|183178809|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.86|1.14||||||For Pertussis - PT the GMC ratio was calculated||1.14|0.86|
91643281|NCT01900392|183178814|OTHER||||||>|0.1|||||||Regression, Linear|||||||>0.1
91771038|NCT03192176|183427580|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|16.68|44.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.49|16.68|<0.0001
91771039|NCT03192176|183427580|SUPERIORITY||LSMean difference|29.1|STANDARD_ERROR_OF_MEAN|7.08|<|0.0001|TWO_SIDED|95.0|15.14|42.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||42.98|15.14|<0.0001
91771040|NCT03192176|183427580|SUPERIORITY||LSMean difference|40.1|STANDARD_ERROR_OF_MEAN|7.19|<|0.0001|TWO_SIDED|95.0|25.96|54.26||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||54.26|25.96|<0.0001
91771041|NCT03192176|183427580|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|7.15||0.0007|TWO_SIDED|95.0|10.28|38.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.42|10.28|0.0007
91771042|NCT03192176|183427580|SUPERIORITY||LSMean difference|26.7|STANDARD_ERROR_OF_MEAN|7.06||0.0002|TWO_SIDED|95.0|1.78|40.55||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||40.55|1.78|0.0002
91771043|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|7.03||0.001|TWO_SIDED|95.0|9.55|37.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||37.22|9.55|0.0010
91771044|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.6||0.004|TWO_SIDED|95.0|6.13|32.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.11|6.13|0.0040
91771045|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.8|STANDARD_ERROR_OF_MEAN|6.62||0.0004|TWO_SIDED|95.0|10.8|36.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.83|10.80|0.0004
91771046|NCT03192176|183427580|SUPERIORITY||LSMean difference|27.2|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.1|40.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||40.24|14.10|<0.0001
91771047|NCT03192176|183427580|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.34|48.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.88|22.34|<0.0001
91771048|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0032|TWO_SIDED|95.0|6.76|33.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.19|6.76|0.0032
91771049|NCT03192176|183427580|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|6.64||0.0003|TWO_SIDED|95.0|11.02|37.13||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||37.13|11.02|0.0003
91771050|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.59||0.0005|TWO_SIDED|95.0|10.17|36.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.08|10.17|0.0005
91771051|NCT03192176|183427580|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|6.82||0.0102|TWO_SIDED|95.0|4.2|31.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||31.04|4.20|0.0102
91771052|NCT03192176|183427580|SUPERIORITY||LSMean difference|25.9|STANDARD_ERROR_OF_MEAN|6.83||0.0002|TWO_SIDED|95.0|12.42|39.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.29|12.42|0.0002
91771053|NCT03192176|183427580|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.87||0.0002|TWO_SIDED|95.0|12.29|39.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.33|12.29|0.0002
91771054|NCT03192176|183427580|SUPERIORITY||LSMean difference|36.3|STANDARD_ERROR_OF_MEAN|6.97|<|0.0001|TWO_SIDED|95.0|22.58|49.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||49.98|22.58|<0.0001
91771055|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.6|STANDARD_ERROR_OF_MEAN|6.94||0.0031|TWO_SIDED|95.0|7.0|34.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.29|7.00|0.0031
91771056|NCT03192176|183427580|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.85||0.0009|TWO_SIDED|95.0|9.43|36.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.38|9.43|0.0009
91771057|NCT03192176|183427580|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.8||0.0009|TWO_SIDED|95.0|9.42|36.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.19|9.42|0.0009
91771058|NCT03192176|183427580|SUPERIORITY||LSMean difference|13.8|STANDARD_ERROR_OF_MEAN|6.71||0.0408|TWO_SIDED|95.0|0.58|26.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||26.97|0.58|0.0408
91771059|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0031|TWO_SIDED|95.0|6.77|33.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||33.21|6.77|0.0031
91771060|NCT03192176|183427580|SUPERIORITY||LSMean difference|22.1|STANDARD_ERROR_OF_MEAN|6.76||0.0012|TWO_SIDED|95.0|8.8|35.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||35.40|8.80|0.0012
91771061|NCT03192176|183427580|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.87|<|0.0001|TWO_SIDED|95.0|16.39|43.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||43.42|16.39|<0.0001
91771062|NCT03192176|183427580|SUPERIORITY||LSMean difference|14.9|STANDARD_ERROR_OF_MEAN|6.84||0.0303|TWO_SIDED|95.0|1.42|28.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||28.32|1.42|0.0303
91771063|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.75||0.004|TWO_SIDED|95.0|6.3|32.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.87|6.30|0.0040
91771064|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.5|STANDARD_ERROR_OF_MEAN|6.71||0.0038|TWO_SIDED|95.0|6.34|32.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.73|6.34|0.0038
91771065|NCT03192176|183427580|SUPERIORITY||LSMean difference|16.0|STANDARD_ERROR_OF_MEAN|6.45||0.0137|TWO_SIDED|95.0|3.29|28.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||28.68|3.29|0.0137
91771066|NCT03192176|183427580|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.45||0.0052|TWO_SIDED|95.0|5.44|30.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.82|5.44|0.0052
91771067|NCT03192176|183427580|SUPERIORITY||LSMean difference|22.6|STANDARD_ERROR_OF_MEAN|6.5||0.0006|TWO_SIDED|95.0|9.81|35.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||35.39|9.81|0.0006
91771068|NCT03192176|183427580|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.41|42.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.32|16.41|<0.0001
91771069|NCT03192176|183427580|SUPERIORITY||LSMean difference|13.7|STANDARD_ERROR_OF_MEAN|6.57||0.0378|TWO_SIDED|95.0|0.78|26.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||26.63|0.78|0.0378
91771070|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.49||0.002|TWO_SIDED|95.0|7.31|32.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||32.85|7.31|0.002
91771071|NCT03192176|183427580|SUPERIORITY||LSMean difference|17.4|STANDARD_ERROR_OF_MEAN|6.44||0.0071|TWO_SIDED|95.0|4.77|30.09||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.09|4.77|0.0071
91771072|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.63||0.002|TWO_SIDED|95.0|7.61|33.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||33.71|7.61|0.0020
91643282|NCT00315328|183178817|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).||||0.96
91771073|NCT03192176|183427580|SUPERIORITY||LSMean difference|18.7|STANDARD_ERROR_OF_MEAN|6.63||0.005|TWO_SIDED|95.0|5.68|31.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||31.79|5.68|0.0050
91771074|NCT03192176|183427580|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.71||0.0003|TWO_SIDED|95.0|11.2|37.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.60|11.20|0.0003
91771075|NCT03192176|183427580|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|18.77|45.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||45.42|18.77|<0.0001
91771076|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.76||0.005|TWO_SIDED|95.0|5.79|32.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||32.38|5.79|0.0050
91771077|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.68||0.0006|TWO_SIDED|95.0|9.95|36.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||36.22|9.95|0.0006
91771078|NCT03192176|183427580|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.62||0.0006|TWO_SIDED|95.0|9.79|35.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||35.85|9.79|0.0006
91771079|NCT03192176|183427580|SUPERIORITY||LSMean difference|18.5|STANDARD_ERROR_OF_MEAN|6.32||0.0036|TWO_SIDED|95.0|6.11|30.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||30.98|6.11|0.0036
91771080|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|6.32||0.0015|TWO_SIDED|95.0|7.77|32.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.65|7.77|0.0015
91771081|NCT03192176|183427580|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|6.39||0.0001|TWO_SIDED|95.0|12.41|37.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||37.57|12.41|0.0001
91771082|NCT03192176|183427580|SUPERIORITY||LSMean difference|29.8|STANDARD_ERROR_OF_MEAN|6.45|<|0.0001|TWO_SIDED|95.0|17.12|42.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.49|17.12|<0.0001
91771083|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.43||0.0026|TWO_SIDED|95.0|6.9|32.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.21|6.90|0.0026
91771084|NCT03192176|183427580|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.36||0.0003|TWO_SIDED|95.0|10.92|35.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||35.94|10.92|0.0003
91771085|NCT03192176|183427580|SUPERIORITY||LSMean difference|21.7|STANDARD_ERROR_OF_MEAN|6.3||0.0006|TWO_SIDED|95.0|9.34|34.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.14|9.34|0.0006
91771086|NCT03192176|183427580|SUPERIORITY||LSMean difference|19.3|STANDARD_ERROR_OF_MEAN|6.37||0.0026|TWO_SIDED|95.0|6.78|31.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||31.83|6.78|0.0026
91771087|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.8|STANDARD_ERROR_OF_MEAN|6.36||0.0012|TWO_SIDED|95.0|8.29|33.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||33.33|8.29|0.0012
91771088|NCT03192176|183427580|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|6.44||0.0001|TWO_SIDED|95.0|12.48|37.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||37.82|12.48|0.0001
91771089|NCT03192176|183427580|SUPERIORITY||LSMean difference|31.9|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|19.11|44.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||44.67|19.11|<0.0001
91771090|NCT03192176|183427580|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.48||0.0021|TWO_SIDED|95.0|7.32|32.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||32.81|7.32|0.0021
91771091|NCT03192176|183427580|SUPERIORITY||LSMean difference|22.7|STANDARD_ERROR_OF_MEAN|6.4||0.0004|TWO_SIDED|95.0|10.1|35.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.29|10.10|0.0004
91643283|NCT00315328|183178818|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.||||0.78
91643284|NCT00315328|183178819|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.||||0.99
91771092|NCT03192176|183427580|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.34||0.0006|TWO_SIDED|95.0|9.42|34.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.38|9.42|0.0006
91771093|NCT03192176|183427580|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|7.82||0.0304|TWO_SIDED|95.0|1.62|32.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.40|1.62|0.0304
91771094|NCT03192176|183427580|SUPERIORITY||LSMean difference|6.8|STANDARD_ERROR_OF_MEAN|7.82||0.3857|TWO_SIDED|95.0|-8.6|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||22.19|-8.60|0.3857
91771095|NCT03192176|183427580|SUPERIORITY||LSMean difference|7.5|STANDARD_ERROR_OF_MEAN|8.06||0.3497|TWO_SIDED|95.0|-8.31|23.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||23.40|-8.31|0.3497
91771096|NCT03192176|183427580|SUPERIORITY||LSMean difference|10.9|STANDARD_ERROR_OF_MEAN|8.05||0.1771|TWO_SIDED|95.0|-4.95|26.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||26.75|-4.95|0.1771
91771097|NCT03192176|183427580|SUPERIORITY||LSMean difference|16.3|STANDARD_ERROR_OF_MEAN|8.1||0.0444|TWO_SIDED|95.0|0.41|32.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.29|0.41|0.0444
91771098|NCT03192176|183427580|SUPERIORITY||LSMean difference|11.7|STANDARD_ERROR_OF_MEAN|8.1||0.15|TWO_SIDED|95.0|-4.25|27.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||27.63|-4.25|0.1500
91771099|NCT03192176|183427580|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|7.83||0.6196|TWO_SIDED|95.0|-11.51|19.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||19.29|-11.51|0.6196
91771100|NCT03192176|183427580|SUPERIORITY||LSMean difference|9.4|STANDARD_ERROR_OF_MEAN|8.48||0.2664|TWO_SIDED|95.0|-7.25|26.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||26.15|-7.25|0.2664
91771101|NCT03192176|183427580|SUPERIORITY||LSMean differencce|4.0|STANDARD_ERROR_OF_MEAN|8.44||0.6388|TWO_SIDED|95.0|-12.66|20.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.59|-12.66|0.6388
91771102|NCT03192176|183427580|SUPERIORITY||LSMean difference|4.9|STANDARD_ERROR_OF_MEAN|8.79||0.5797|TWO_SIDED|95.0|-12.43|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.19|-12.43|0.5797
91771103|NCT03192176|183427580|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|8.78||0.4817|TWO_SIDED|95.0|-11.1|23.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.47|-11.10|0.4817
91771104|NCT03192176|183427580|SUPERIORITY||LSMean differencce|10.5|STANDARD_ERROR_OF_MEAN|8.8||0.2358|TWO_SIDED|95.0|-6.87|27.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||27.79|-6.87|0.2358
91771105|NCT03192176|183427580|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|8.86||0.107|TWO_SIDED|95.0|-3.11|31.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||31.77|-3.11|0.1070
91771106|NCT03192176|183427580|SUPERIORITY||LSMean difference|6.7|STANDARD_ERROR_OF_MEAN|8.47||0.4268|TWO_SIDED|95.0|-9.94|23.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.43|-9.94|0.4268
91643285|NCT00315328|183178820|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||.04
91643286|NCT00315328|183178820|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||0.003
91771107|NCT03192176|183427580|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|8.61||0.9197|TWO_SIDED|95.0|-17.81|16.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.08|-17.81|0.9197
91771108|NCT03192176|183427580|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|8.54||0.9954|TWO_SIDED|95.0|-16.77|16.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.87|-16.77|0.9954
91771109|NCT03192176|183427580|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|9.0||0.9607|TWO_SIDED|95.0|-17.28|18.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||18.17|-17.28|0.9607
91771110|NCT03192176|183427580|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|8.87||0.6625|TWO_SIDED|95.0|-21.33|13.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.59|-21.33|0.6625
91771111|NCT03192176|183427580|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|9.01||0.9952|TWO_SIDED|95.0|-17.81|17.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||17.70|-17.81|0.9952
91771112|NCT03192176|183427580|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|9.02||0.4001|TWO_SIDED|95.0|-10.16|25.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||25.36|-10.16|0.4001
91771113|NCT03192176|183427580|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|8.54||0.751|TWO_SIDED|95.0|-19.52|14.1||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||14.10|-19.52|0.7510
91771114|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0018|TWO_SIDED|95.0|1.95|18.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.64|1.95|0.0018
91771115|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|8.28||||0.0002|TWO_SIDED|95.0|2.7|25.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.42|2.70|0.0002
91771116|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|10.92|||<|0.0001|TWO_SIDED|95.0|3.53|33.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.74|3.53|<0.0001
91771117|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|12.18|||<|0.0001|TWO_SIDED|95.0|3.91|37.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.89|3.91|<0.0001
91771118|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2244|TWO_SIDED|95.0|0.64|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.92|0.64|0.2244
91771119|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|8.58||||0.0002|TWO_SIDED|95.0|2.77|26.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.53|2.77|0.0002
91771120|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|8.25||||0.0002|TWO_SIDED|95.0|2.71|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.13|2.71|0.0002
91771121|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0149|TWO_SIDED|95.0|1.24|7.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.45|1.24|0.0149
91771122|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.65||||0.0011|TWO_SIDED|95.0|1.85|11.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.73|1.85|0.0011
91771123|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0001|TWO_SIDED|95.0|2.46|16.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.45|2.46|0.0001
91643287|NCT00315328|183178821|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.||||<0.01
91643288|NCT00315328|183178822|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.||||<0.01
91643289|NCT00315328|183178823|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.||||0.70
91771124|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.87||||0.0001|TWO_SIDED|95.0|2.56|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.56|0.0001
91771125|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0897|TWO_SIDED|95.0|0.89|5.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.34|0.89|0.0897
91771126|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.46||||0.007|TWO_SIDED|95.0|1.42|8.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.53|1.42|0.0070
91771127|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0041|TWO_SIDED|95.0|1.52|9.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.23|1.52|0.0041
91771128|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0254|TWO_SIDED|95.0|1.13|6.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.78|1.13|0.0254
91771129|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0032|TWO_SIDED|95.0|1.59|10.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.04|1.59|0.0032
91771130|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0002|TWO_SIDED|95.0|2.37|16.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.51|2.37|0.0002
91771131|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|8.78|||<|0.0001|TWO_SIDED|95.0|3.0|25.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.70|3.00|<0.0001
91771132|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0214|TWO_SIDED|95.0|1.17|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.18|1.17|0.0214
91771133|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0049|TWO_SIDED|95.0|1.48|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.09|1.48|0.0049
91771134|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0078|TWO_SIDED|95.0|1.38|8.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.22|1.38|0.0078
91771135|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0727|TWO_SIDED|95.0|0.93|5.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.63|0.93|0.0727
91771136|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0199|TWO_SIDED|95.0|1.19|7.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.29|1.19|0.0199
91771137|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0034|TWO_SIDED|95.0|1.61|11.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.01|1.61|0.0034
91771138|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0007|TWO_SIDED|95.0|2.16|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.26|2.16|0.0007
91771139|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1206|TWO_SIDED|95.0|0.83|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.92|0.83|0.1206
91643290|NCT00315328|183178824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||||95.0|-0.03|0.17||||||95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.||0.17|-0.03|
91771140|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.58||||0.007|TWO_SIDED|95.0|1.42|9.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.03|1.42|0.0070
91771141|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.41||||0.0088|TWO_SIDED|95.0|1.36|8.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.54|1.36|0.0088
91771142|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4485|TWO_SIDED|95.0|0.58|3.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.40|0.58|0.4485
91771143|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.92||||0.0255|TWO_SIDED|95.0|1.14|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.47|1.14|0.0255
91771144|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0066|TWO_SIDED|95.0|1.49|11.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.75|1.49|0.0066
91771145|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0061|TWO_SIDED|95.0|1.53|13.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.01|1.53|0.0061
91706180|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22||||0.4776|TWO_SIDED|90.0|-21.61|25.87|||Barnard exact test|||Day 14||25.87|-21.61|0.4776
91771146|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0879|TWO_SIDED|95.0|0.89|5.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.57|0.89|0.0879
91771147|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0389|TWO_SIDED|95.0|1.05|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.83|1.05|0.0389
91771148|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0446|TWO_SIDED|95.0|1.02|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.73|1.02|0.0446
91771149|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8196|TWO_SIDED|95.0|0.45|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.72|0.45|0.8196
91771150|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.0||||0.145|TWO_SIDED|95.0|0.79|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.10|0.79|0.1450
91771151|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.08||||0.0114|TWO_SIDED|95.0|1.37|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.11|1.37|0.0114
91771152|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0307|TWO_SIDED|95.0|1.12|9.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.71|1.12|0.0307
91771153|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5921|TWO_SIDED|95.0|0.51|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.24|0.51|0.5921
91771154|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0502|TWO_SIDED|95.0|1.0|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.26|1.00|0.0502
91771155|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0224|TWO_SIDED|95.0|1.18|9.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.25|1.18|0.0224
91771156|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7225|TWO_SIDED|95.0|0.47|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||2.93|0.47|0.7225
91771157|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0762|TWO_SIDED|95.0|0.91|6.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.48|0.91|0.0762
91643291|NCT00315328|183178826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||||95.0|-0.02|0.18||||||95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.||0.18|-0.02|
91643292|NCT00315328|183178827|NON_INFERIORITY_OR_EQUIVALENCE|Treatment equivalence was to be declared if the ends of the 2 1-sided 95% confidence intervals constructed on the difference between adjusted mean visual acuity scores were completely contained within the designated equivalence interval of +/- 5 letters.|Mean Difference (Net)|1.2||||||95.0|-0.7|3.1|||ANCOVA|||The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.||3.1|-0.7|
91771158|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0252|TWO_SIDED|95.0|1.17|10.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.53|1.17|0.0252
91771159|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.98||||0.049|TWO_SIDED|95.0|1.0|8.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.87|1.00|0.0490
91771160|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1773|TWO_SIDED|95.0|0.74|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.30|0.74|0.1773
91771161|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0609|TWO_SIDED|95.0|0.96|7.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.16|0.96|0.0609
91771162|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1364|TWO_SIDED|95.0|0.79|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.61|0.79|0.1364
91771163|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5268|TWO_SIDED|95.0|0.53|3.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.51|0.53|0.5268
91771164|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1645|TWO_SIDED|95.0|0.75|5.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.46|0.75|0.1645
91771165|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0215|TWO_SIDED|95.0|1.22|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||12.57|1.22|0.0215
91771166|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.04||||0.06|TWO_SIDED|95.0|0.95|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|0.95|0.0600
91771167|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6503|TWO_SIDED|95.0|0.47|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.32|0.47|0.6503
91771168|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0683|TWO_SIDED|95.0|0.93|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.93|0.0683
91771169|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0618|TWO_SIDED|95.0|0.95|8.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.44|0.95|0.0618
91771170|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5621|TWO_SIDED|95.0|0.5|3.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.63|0.50|0.5621
91771171|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.92||||0.2182|TWO_SIDED|95.0|0.68|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.40|0.68|0.2182
91771172|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.11||||0.06|TWO_SIDED|95.0|0.95|10.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.15|0.95|0.0600
91643293|NCT00315328|183178830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.4|2.2|||ANCOVA|||95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.||2.2|0.4|
91643294|NCT00826176|183178832|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|6.4||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
91643295|NCT00826176|183178832|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|3.2||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
91771173|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.6||||0.029|TWO_SIDED|95.0|1.17|18.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.12|1.17|0.0290
91771174|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8485|TWO_SIDED|95.0|0.4|3.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.04|0.40|0.8485
91771175|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1652|TWO_SIDED|95.0|0.73|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.42|0.73|0.1652
91771176|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2244|TWO_SIDED|95.0|0.67|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.65|0.67|0.2244
91771177|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2097|TWO_SIDED|95.0|0.71|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.84|0.71|0.2097
91771178|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3708|TWO_SIDED|95.0|0.6|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.92|0.60|0.3708
91771179|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0704|TWO_SIDED|95.0|0.92|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.66|0.92|0.0704
91771180|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|7.21||||0.004|TWO_SIDED|95.0|1.88|27.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.73|1.88|0.0040
91771181|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1625|TWO_SIDED|95.0|0.75|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.55|0.75|0.1625
91771182|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0093|TWO_SIDED|95.0|1.46|14.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.50|1.46|0.0093
91771183|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|4.44||||0.0103|TWO_SIDED|95.0|1.42|13.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.87|1.42|0.0103
91771184|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.89||||0.1965|TWO_SIDED|95.0|0.72|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.72|0.1965
91771185|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0549|TWO_SIDED|95.0|0.98|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.42|0.98|0.0549
91771186|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0503|TWO_SIDED|95.0|1.0|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.09|1.00|0.0503
91771187|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|7.03||||0.0046|TWO_SIDED|95.0|1.82|27.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||27.10|1.82|0.0046
91771188|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0866|TWO_SIDED|95.0|0.88|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.88|0.88|0.0866
91643296|NCT00826176|183178832|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence between the two subject populations was to be claimed in the event that the two-sided 95% confidence interval was entirely within the interval ranging from -60 to +60 seconds.|median difference (seconds)|49.0||||||95.0|30.0|72.0|||||The estimated median difference (Chinese minus Caucasian) in time to recovery of the T4/T1 ratio to 0.9.|||72|30|
91771189|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|5.96||||0.0045|TWO_SIDED|95.0|1.74|20.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.40|1.74|0.0045
91771190|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0207|TWO_SIDED|95.0|1.22|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.62|1.22|0.0207
91771191|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2127|TWO_SIDED|95.0|0.7|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.91|0.70|0.2127
91771192|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1521|TWO_SIDED|95.0|0.77|5.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.43|0.77|0.1521
91771193|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0098|TWO_SIDED|95.0|1.48|17.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.70|1.48|0.0098
91771194|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0047|TWO_SIDED|95.0|1.82|27.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||27.50|1.82|0.0047
91771195|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1817|TWO_SIDED|95.0|0.72|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.51|0.72|0.1817
91771196|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0042|TWO_SIDED|95.0|1.77|20.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.95|1.77|0.0042
91771197|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0039|TWO_SIDED|95.0|1.78|20.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.74|1.78|0.0039
91771198|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7025|TWO_SIDED|95.0|0.42|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.42|0.7025
91771199|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9599|TWO_SIDED|95.0|0.36|2.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.97|0.36|0.9599
91771200|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9671|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.10|0.34|0.9671
91771201|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.26||||0.681|TWO_SIDED|95.0|0.42|3.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.83|0.42|0.6810
91771202|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6346|TWO_SIDED|95.0|0.43|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.04|0.43|0.6346
91771203|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7929|TWO_SIDED|95.0|0.38|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.38|0.7929
91771204|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8188|TWO_SIDED|95.0|0.39|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.28|0.39|0.8188
91771205|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8226|TWO_SIDED|95.0|0.3|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.60|0.30|0.8226
91771206|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9088|TWO_SIDED|95.0|0.32|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.72|0.32|0.9088
91771207|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6189|TWO_SIDED|95.0|0.24|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.24|0.6189
91771208|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6463|TWO_SIDED|95.0|0.42|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.03|0.42|0.6463
91771209|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.47||||0.506|TWO_SIDED|95.0|0.47|4.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.54|0.47|0.5060
91771210|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3842|TWO_SIDED|95.0|0.53|5.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.31|0.53|0.3842
91771211|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5021|TWO_SIDED|95.0|0.49|4.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.23|0.49|0.5021
91771212|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.42||||0.1349|TWO_SIDED|95.0|0.14|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.31|0.14|0.1349
91771213|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3191|TWO_SIDED|95.0|0.19|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.19|0.3191
91771214|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.3||||0.0623|TWO_SIDED|95.0|0.09|1.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.06|0.09|0.0623
91771215|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1958|TWO_SIDED|95.0|0.15|1.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.48|0.15|0.1958
91771216|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4353|TWO_SIDED|95.0|0.19|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.19|0.4353
91771217|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9729|TWO_SIDED|95.0|0.31|3.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.31|0.31|0.9729
91771218|NCT03192176|183427581|SUPERIORITY||Odds Ratio (OR)|0.64||||0.4211|TWO_SIDED|95.0|0.22|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.89|0.22|0.4211
91771219|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.05||||0.1938|TWO_SIDED|95.0|0.57|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.35|0.57|0.1938
91771220|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|6.97||||0.0162|TWO_SIDED|95.0|1.43|33.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.91|1.43|0.0162
91771221|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|14.37||||0.0008|TWO_SIDED|95.0|3.04|67.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||67.96|3.04|0.0008
91771222|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|16.02||||0.0005|TWO_SIDED|95.0|3.39|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||75.68|3.39|0.0005
91771223|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1971|TWO_SIDED|95.0|0.56|16.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.17|0.56|0.1971
91771224|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0811|TWO_SIDED|95.0|0.83|22.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.27|0.83|0.0811
91518613|NCT01570829|182911575|SUPERIORITY|||||||0.4||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Physical Health domain data.||||0.40
91643297|NCT00448630|183178837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
91706181|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|27.62||||0.0347|TWO_SIDED|90.0|2.53|50.78|||Barnard exact test|||Day 14||50.78|2.53|0.0347
91771225|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|11.44||||0.0021|TWO_SIDED|95.0|2.43|53.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||53.94|2.43|0.0021
91771226|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.11||||0.137|TWO_SIDED|95.0|0.79|5.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.64|0.79|0.1370
91771227|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0181|TWO_SIDED|95.0|1.22|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.40|1.22|0.0181
91518614|NCT01570829|182911575|SUPERIORITY|||||||0.34||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Mental Health domain data.||||0.34
91643298|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.490
91706182|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|7.94||||0.3343|TWO_SIDED|90.0|-13.71|31.59|||Barnard exact test|||Day 14||31.59|-13.71|0.3343
91706183|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|33.33||||0.0117|TWO_SIDED|90.0|8.35|55.0|||Barnard exact test|||Day 14||55.00|8.35|0.0117
91771228|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|6.43||||0.0002|TWO_SIDED|95.0|2.43|17.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.05|2.43|0.0002
91771229|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0003|TWO_SIDED|95.0|2.26|16.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.31|2.26|0.0003
91771230|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3241|TWO_SIDED|95.0|0.61|4.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.49|0.61|0.3241
91771231|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2249|TWO_SIDED|95.0|0.68|5.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.03|0.68|0.2249
91771232|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.53||||0.0096|TWO_SIDED|95.0|1.36|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.18|1.36|0.0096
91771233|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0768|TWO_SIDED|95.0|0.91|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.05|0.91|0.0768
91771234|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.91||||0.00251|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.39|1.14|0.00251
91771235|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0002|TWO_SIDED|95.0|2.3|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.57|2.30|0.0002
91771236|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|7.29|||<|0.0001|TWO_SIDED|95.0|2.7|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||19.71|2.70|<0.0001
91771237|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1144|TWO_SIDED|95.0|0.83|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.50|0.83|0.1144
91771238|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1341|TWO_SIDED|95.0|0.8|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.30|0.80|0.1341
91771239|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0017|TWO_SIDED|95.0|1.75|11.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.22|1.75|0.0017
91643299|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91771240|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1488|TWO_SIDED|95.0|0.77|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.50|0.77|0.1488
91771241|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0043|TWO_SIDED|95.0|1.54|10.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.30|1.54|0.0043
91771242|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.53||||0.0005|TWO_SIDED|95.0|2.1|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.57|2.10|0.0005
91771243|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.0001|TWO_SIDED|95.0|4.85|43.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.58|4.85|<0.0001
91643300|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.006
91643301|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91643302|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.003
91771244|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0262|TWO_SIDED|95.0|1.14|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.68|1.14|0.0262
91771245|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0009|TWO_SIDED|95.0|1.95|13.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.19|1.95|0.0009
91771246|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0006|TWO_SIDED|95.0|2.06|13.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.80|2.06|0.0006
91771247|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3673|TWO_SIDED|95.0|0.61|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.75|0.61|0.3673
91771248|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1207|TWO_SIDED|95.0|0.83|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.91|0.83|0.1207
91771249|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0011|TWO_SIDED|95.0|1.9|13.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.21|1.90|0.0011
91771250|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|3.08|27.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||27.38|3.08|<0.0001
91771251|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0594|TWO_SIDED|95.0|0.97|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.86|0.97|0.0594
91771252|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.47||||0.05|TWO_SIDED|95.0|1.0|6.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.09|1.00|0.0500
91771253|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.03|1.29|0.0123
91771254|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2243|TWO_SIDED|95.0|0.71|4.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.37|0.71|0.2243
91643303|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91771255|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0976|TWO_SIDED|95.0|0.87|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.24|0.87|0.0976
91771256|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.25|16.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.44|2.25|0.0004
91771257|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|9.13|||<|0.0001|TWO_SIDED|95.0|3.04|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.40|3.04|<0.0001
91771258|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1237|TWO_SIDED|95.0|0.82|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.17|0.82|0.1237
91771259|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0226|TWO_SIDED|95.0|1.16|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.41|1.16|0.0226
91643304|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.050
91643305|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0012
91643306|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0078
91643307|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
91771260|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0069|TWO_SIDED|95.0|1.42|8.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.91|1.42|0.0069
91771261|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1666|TWO_SIDED|95.0|0.76|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.75|0.76|0.1666
91771262|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0317|TWO_SIDED|95.0|1.09|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|1.09|0.0317
91771263|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0011|TWO_SIDED|95.0|1.94|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.39|1.94|0.0011
91771264|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0001|TWO_SIDED|95.0|2.81|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||25.46|2.81|0.0001
91771265|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1142|TWO_SIDED|95.0|0.84|5.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.27|0.84|0.1142
91771266|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.91||||0.025|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.39|1.14|0.0250
91771267|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0166|TWO_SIDED|95.0|1.23|7.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.75|1.23|0.0166
91771268|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6033|TWO_SIDED|95.0|0.52|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.11|0.52|0.6033
91771269|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.05||||0.117|TWO_SIDED|95.0|0.84|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.02|0.84|0.1170
91771270|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.69||||0.04|TWO_SIDED|95.0|1.05|6.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.91|1.05|0.0400
91771271|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.61||||0.002|TWO_SIDED|95.0|1.88|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.72|1.88|0.0020
91643308|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0133
91771272|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5177|TWO_SIDED|95.0|0.54|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.54|0.5177
91771273|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2117|TWO_SIDED|95.0|0.72|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.48|0.72|0.2117
91771274|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0426|TWO_SIDED|95.0|1.03|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.67|1.03|0.0426
91771275|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3508|TWO_SIDED|95.0|0.62|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.82|0.62|0.3508
91771276|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4431|TWO_SIDED|95.0|0.58|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.45|0.58|0.4431
91643309|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0142||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0142
91643310|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0265
91643311|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1613||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1613
91771277|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|4.27||||0.005|TWO_SIDED|95.0|1.55|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.78|1.55|0.0050
91771278|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0023|TWO_SIDED|95.0|1.84|16.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||16.30|1.84|0.0023
91771279|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5663|TWO_SIDED|95.0|0.52|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.32|0.52|0.5663
91771280|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0461|TWO_SIDED|95.0|1.02|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.83|1.02|0.0461
91771281|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0552|TWO_SIDED|95.0|0.98|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.38|0.98|0.0552
91771282|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1536|TWO_SIDED|95.0|0.78|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.88|0.78|0.1536
91771283|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.69||||0.2575|TWO_SIDED|95.0|0.68|4.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.20|0.68|0.2575
91771284|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0096|TWO_SIDED|95.0|1.38|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.11|1.38|0.0096
91771285|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|8.48||||0.0003|TWO_SIDED|95.0|2.69|26.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||26.76|2.69|0.0003
91771286|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1047|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.1047
91643312|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2644||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2644
91643313|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||5e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000005
91771287|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.91||||0.006|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.0060
91771288|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0414|TWO_SIDED|95.0|1.04|6.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.71|1.04|0.0414
91771289|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0809|TWO_SIDED|95.0|0.9|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.89|0.90|0.0809
91771290|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2377|TWO_SIDED|95.0|0.69|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.34|0.69|0.2377
91771291|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0087|TWO_SIDED|95.0|1.44|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.34|1.44|0.0087
91771292|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0022|TWO_SIDED|95.0|1.9|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||18.94|1.90|0.0022
91643314|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7385||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7385
91643315|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
91643316|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6813
91643317|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
91643318|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2237||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2237
91643319|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5774
91771293|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4788|TWO_SIDED|95.0|0.55|3.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.55|0.55|0.4788
91771294|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.98||||0.0074|TWO_SIDED|95.0|1.45|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.94|1.45|0.0074
91771295|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0187|TWO_SIDED|95.0|1.22|8.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.75|1.22|0.0187
91771296|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3443|TWO_SIDED|95.0|0.62|4.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.00|0.62|0.3443
91771297|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.66||||0.2867|TWO_SIDED|95.0|0.65|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.22|0.65|0.2867
91771298|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0044|TWO_SIDED|95.0|1.66|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.78|1.66|0.0044
91771299|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0038|TWO_SIDED|95.0|1.74|17.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.87|1.74|0.0038
91771300|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.09||||0.1424|TWO_SIDED|95.0|0.78|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.60|0.78|0.1424
91771301|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0191|TWO_SIDED|95.0|1.22|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.07|1.22|0.0191
91771302|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0244|TWO_SIDED|95.0|1.16|8.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.56|1.16|0.0244
91771303|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1462|TWO_SIDED|95.0|0.71|9.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.67|0.71|0.1462
91643320|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
91771304|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7403|TWO_SIDED|95.0|0.32|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.97|0.32|0.7403
91771305|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2144|TWO_SIDED|95.0|0.61|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.07|0.61|0.2144
91771306|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4321|TWO_SIDED|95.0|0.44|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.96|0.44|0.4321
91771307|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1778|TWO_SIDED|95.0|0.66|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.75|0.66|0.1778
91771308|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8016|TWO_SIDED|95.0|0.28|5.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.20|0.28|0.8016
91771309|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|2.62||||0.1486|TWO_SIDED|95.0|0.71|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.71|0.1486
91643321|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2502||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2502
91643322|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5224||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5224
91643323|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
91771310|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.51||||0.2881|TWO_SIDED|95.0|0.15|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.77|0.15|0.2881
91771311|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1217|TWO_SIDED|95.0|0.1|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.31|0.10|0.1217
91771312|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1027|TWO_SIDED|95.0|0.07|1.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.28|0.07|0.1027
91771313|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.18||||0.0428|TWO_SIDED|95.0|0.03|0.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||0.94|0.03|0.0428
91771314|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5943|TWO_SIDED|95.0|0.21|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.21|0.5943
91771315|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.94||||0.928|TWO_SIDED|95.0|0.27|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.27|0.9280
91771316|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.94||||0.916|TWO_SIDED|95.0|0.3|2.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.94|0.30|0.9160
91771317|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2262|TWO_SIDED|95.0|0.11|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.11|0.2262
91771318|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2682|TWO_SIDED|95.0|0.13|1.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.75|0.13|0.2682
91771319|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.4||||0.2344|TWO_SIDED|95.0|0.09|1.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.81|0.09|0.2344
91771320|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0835|TWO_SIDED|95.0|0.04|1.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.22|0.04|0.0835
91771321|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6322|TWO_SIDED|95.0|0.19|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.72|0.19|0.6322
91771322|NCT03192176|183427582|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4845|TWO_SIDED|95.0|0.2|2.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.17|0.20|0.4845
91771323|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9587|TWO_SIDED|95.0|0.06|17.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.98|0.06|0.9587
91771324|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9895|TWO_SIDED|95.0|0.06|16.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.89|0.06|0.9895
91771325|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0736|TWO_SIDED|95.0|0.83|63.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||63.32|0.83|0.0736
91771326|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0767|TWO_SIDED|95.0|0.81|61.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||61.78|0.81|0.0767
91771327|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.51||||0.288|TWO_SIDED|95.0|0.35|35.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.49|0.35|0.2880
91643324|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
91771328|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.96||||0.5894|TWO_SIDED|95.0|0.17|22.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.47|0.17|0.5894
91771329|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.45||||0.3093|TWO_SIDED|95.0|0.44|13.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.78|0.44|0.3093
91771330|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1606|TWO_SIDED|95.0|0.62|17.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.58|0.62|0.1606
91771331|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0019|TWO_SIDED|95.0|2.5|56.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||56.87|2.50|0.0019
91771332|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|14.4||||0.0008|TWO_SIDED|95.0|3.02|68.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||68.73|3.02|0.0008
91771333|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8803|TWO_SIDED|95.0|0.11|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.55|0.11|0.8803
91771334|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.98||||0.2096|TWO_SIDED|95.0|0.54|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.46|0.54|0.2096
91771335|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|7.69||||0.011|TWO_SIDED|95.0|1.6|37.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||37.11|1.60|0.0110
91771336|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0845|TWO_SIDED|95.0|0.86|11.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.11|0.86|0.0845
91771337|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1094|TWO_SIDED|95.0|0.79|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.13|0.79|0.1094
91771338|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|8.97||||0.0004|TWO_SIDED|95.0|2.68|30.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||30.07|2.68|0.0004
91643325|NCT00448630|183178838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8166||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8166
91771339|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0016|TWO_SIDED|95.0|2.1|24.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.09|2.10|0.0016
91771340|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4375|TWO_SIDED|95.0|0.44|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.64|0.44|0.4375
91771341|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.02||||0.0898|TWO_SIDED|95.0|0.84|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|0.84|0.0898
91771342|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0027|TWO_SIDED|95.0|1.9|21.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.06|1.90|0.0027
91771343|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1242|TWO_SIDED|95.0|0.78|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.64|0.78|0.1242
91771344|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0815|TWO_SIDED|95.0|0.88|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.03|0.88|0.0815
91643326|NCT00448630|183178839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
91706184|NCT00938587|183306678|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.71||||0.372|TWO_SIDED|90.0|-15.86|27.04|||Barnard exact test|||Day 14||27.04|-15.86|0.3720
91771345|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|6.21||||0.0009|TWO_SIDED|95.0|2.11|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.27|2.11|0.0009
91771346|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0027|TWO_SIDED|95.0|1.78|15.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.64|1.78|0.0027
91771347|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.35||||0.6267|TWO_SIDED|95.0|0.41|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.46|0.41|0.6267
91771348|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0709|TWO_SIDED|95.0|0.92|8.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.38|0.92|0.0709
91771349|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0049|TWO_SIDED|95.0|1.59|13.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.59|1.59|0.0049
91771350|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5107|TWO_SIDED|95.0|0.45|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.98|0.45|0.5107
91771351|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1297|TWO_SIDED|95.0|0.78|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.22|0.78|0.1297
91771352|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|7.04||||0.0005|TWO_SIDED|95.0|2.34|21.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.22|2.34|0.0005
91771353|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0001|TWO_SIDED|95.0|2.82|25.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||25.63|2.82|0.0001
91771354|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.84||||0.299|TWO_SIDED|95.0|0.58|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.58|0.2990
91771355|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.38||||0.1355|TWO_SIDED|95.0|0.76|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.76|0.1355
91771356|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|5.17||||0.0028|TWO_SIDED|95.0|1.76|15.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.14|1.76|0.0028
91771357|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7422|TWO_SIDED|95.0|0.41|3.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.47|0.41|0.7422
91771358|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.44||||0.075|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.52|0.91|0.0750
91771359|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0006|TWO_SIDED|95.0|2.16|16.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.67|2.16|0.0006
91771360|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|7.63||||0.0001|TWO_SIDED|95.0|2.69|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.65|2.69|0.0001
91771361|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8405|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.23|0.38|0.8405
91771362|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6257|TWO_SIDED|95.0|0.45|3.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.79|0.45|0.6257
91771363|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.92||||0.006|TWO_SIDED|95.0|1.48|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.36|1.48|0.0060
91771364|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.74||||0.3556|TWO_SIDED|95.0|0.54|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.68|0.54|0.3556
91771365|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.67||||0.019|TWO_SIDED|95.0|1.24|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.90|1.24|0.0190
91771366|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|9.9|||<|0.0001|TWO_SIDED|95.0|3.2|30.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||30.68|3.20|<0.0001
91771367|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|14.81|||<|0.0001|TWO_SIDED|95.0|4.67|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||47.05|4.67|<0.0001
91771368|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1936|TWO_SIDED|95.0|0.68|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.68|0.1936
91771369|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0335|TWO_SIDED|95.0|1.1|10.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.47|1.10|0.0335
91771370|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0009|TWO_SIDED|95.0|2.1|18.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.17|2.10|0.0009
91771371|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|95.0|0.34|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.39|0.34|0.8330
91771372|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.56||||0.341|TWO_SIDED|95.0|0.62|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.62|0.3410
91771373|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0075|TWO_SIDED|95.0|1.42|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|1.42|0.0075
91771374|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|4.86||||0.002|TWO_SIDED|95.0|1.78|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.26|1.78|0.0020
91771375|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6216|TWO_SIDED|95.0|0.29|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.10|0.29|0.6216
91771376|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4615|TWO_SIDED|95.0|0.55|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.71|0.55|0.4615
91771377|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0281|TWO_SIDED|95.0|1.12|7.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.19|1.12|0.0281
91771378|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8028|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.8028
91771379|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.21||||0.6846|TWO_SIDED|95.0|0.48|3.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.07|0.48|0.6846
91771380|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0149|TWO_SIDED|95.0|1.26|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|1.26|0.0149
91771381|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|5.64||||0.0009|TWO_SIDED|95.0|2.03|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.65|2.03|0.0009
91771382|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6434|TWO_SIDED|95.0|0.29|2.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.15|0.29|0.6434
91771383|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4784|TWO_SIDED|95.0|0.54|3.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.69|0.54|0.4784
91771384|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0955|TWO_SIDED|95.0|0.87|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.55|0.87|0.0955
91771385|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.06||||0.9082|TWO_SIDED|95.0|0.4|2.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.79|0.40|0.9082
91771386|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6478|TWO_SIDED|95.0|0.48|3.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.21|0.48|0.6478
91771387|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0104|TWO_SIDED|95.0|1.35|9.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.82|1.35|0.0104
91771388|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|6.66||||0.0004|TWO_SIDED|95.0|2.34|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.94|2.34|0.0004
91771389|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.91||||0.856|TWO_SIDED|95.0|0.34|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.45|0.34|0.8560
91771390|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3319|TWO_SIDED|95.0|0.62|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.17|0.62|0.3319
91771391|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0747|TWO_SIDED|95.0|0.92|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.95|0.92|0.0747
91771392|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8986|TWO_SIDED|95.0|0.41|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.76|0.41|0.8986
91771393|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9712|TWO_SIDED|95.0|0.38|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.53|0.38|0.9712
91771394|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|3.31||||0.091|TWO_SIDED|95.0|1.22|8.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.98|1.22|0.0910
91518615|NCT00675766|182911576|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.||Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.001
91643327|NCT00448630|183178840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
91771395|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|5.68||||0.0011|TWO_SIDED|95.0|2.01|16.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.06|2.01|0.0011
91771396|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8466|TWO_SIDED|95.0|0.35|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.39|0.35|0.8466
91771397|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1409|TWO_SIDED|95.0|0.79|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.21|0.79|0.1409
91771398|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1212|TWO_SIDED|95.0|0.82|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.25|0.82|0.1212
91771399|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4269|TWO_SIDED|95.0|0.56|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.88|0.56|0.4269
91771400|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5454|TWO_SIDED|95.0|0.52|3.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.49|0.52|0.5454
91771401|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0595|TWO_SIDED|95.0|0.96|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.15|0.96|0.0595
91771402|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0041|TWO_SIDED|95.0|1.62|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.98|1.62|0.0041
91771403|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6121|TWO_SIDED|95.0|0.28|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.13|0.28|0.6121
91771404|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2329|TWO_SIDED|95.0|0.68|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.75|0.68|0.2329
91771405|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0891|TWO_SIDED|95.0|0.88|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.90|0.88|0.0891
91771406|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.55||||0.6857|TWO_SIDED|95.0|0.03|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.97|0.03|0.6857
91771407|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.56||||0.7291|TWO_SIDED|95.0|0.12|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.71|0.12|0.7291
91771408|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8951|TWO_SIDED|95.0|0.05|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.41|0.05|0.8951
91771409|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.66||||0.6865|TWO_SIDED|95.0|0.14|19.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.74|0.14|0.6865
91771410|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9132|TWO_SIDED|95.0|0.07|20.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.24|0.07|0.9132
91771411|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.38||||0.7982|TWO_SIDED|95.0|0.12|16.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.59|0.12|0.7982
91771412|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9029|TWO_SIDED|95.0|0.09|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||15.57|0.09|0.9029
91771413|NCT03192176|183427583|SUPERIORITY||Odds Ratio (OR)|0.69||||0.7971|TWO_SIDED|95.0|0.04|11.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.94|0.04|0.7971
91771414|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|0.67||||0.7899|TWO_SIDED|95.0|0.04|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.34|0.04|0.7899
91771415|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|0.86||||0.9186|TWO_SIDED|95.0|0.05|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.73|0.05|0.9186
91771416|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.19||||0.5303|TWO_SIDED|95.0|0.19|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||25.46|0.19|0.5303
91771417|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|5.85||||0.1149|TWO_SIDED|95.0|0.65|52.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||52.66|0.65|0.1149
91771418|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|9.07||||0.0442|TWO_SIDED|95.0|1.06|77.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||77.71|1.06|0.0442
91771419|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2851|TWO_SIDED|95.0|0.35|35.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||35.68|0.35|0.2851
91771420|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.22||||0.2073|TWO_SIDED|95.0|0.45|39.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||39.48|0.45|0.2073
91771421|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.68||||0.27|TWO_SIDED|95.0|0.36|37.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||37.16|0.36|0.2700
91771422|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.41||||0.2982|TWO_SIDED|95.0|0.34|34.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||34.27|0.34|0.2982
91771423|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|12.3||||0.0204|TWO_SIDED|95.0|1.47|102.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||102.6|1.47|0.0204
91771424|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|11.1||||0.027|TWO_SIDED|95.0|1.31|93.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||93.74|1.31|0.0270
91771425|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.22||||0.5224|TWO_SIDED|95.0|0.19|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.68|0.19|0.5224
91771426|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1635|TWO_SIDED|95.0|0.52|46.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||46.35|0.52|0.1635
91771427|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|10.97||||0.0266|TWO_SIDED|95.0|1.32|91.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||91.15|1.32|0.0266
91771428|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.69||||0.4299|TWO_SIDED|95.0|0.23|31.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||31.21|0.23|0.4299
91771429|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.87||||0.1667|TWO_SIDED|95.0|0.52|45.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||45.84|0.52|0.1667
91771430|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|8.11||||0.0592|TWO_SIDED|95.0|0.92|71.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.35|0.92|0.0592
91771431|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|18.28||||0.007|TWO_SIDED|95.0|2.21|151.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||151.2|2.21|0.0070
91771432|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.79||||0.2594|TWO_SIDED|95.0|0.37|38.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||38.32|0.37|0.2594
91771433|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|8.14||||0.0589|TWO_SIDED|95.0|0.92|71.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.67|0.92|0.0589
91771434|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0338|TWO_SIDED|95.0|1.19|85.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||85.20|1.19|0.0338
91771435|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7756|TWO_SIDED|95.0|0.12|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.88|0.12|0.7756
91771436|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9246|TWO_SIDED|95.0|0.2|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.74|0.20|0.9246
91771437|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0177|TWO_SIDED|95.0|1.34|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.93|1.34|0.0177
91771438|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0178|TWO_SIDED|95.0|1.34|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.65|1.34|0.0178
91771439|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.17||||0.8564|TWO_SIDED|95.0|0.22|6.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.20|0.22|0.8564
91771440|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.52||||0.2202|TWO_SIDED|95.0|0.58|11.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.00|0.58|0.2202
91771441|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.37||||0.2498|TWO_SIDED|95.0|0.55|10.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.25|0.55|0.2498
91771442|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0576|TWO_SIDED|95.0|0.93|72.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.29|0.93|0.0576
91771443|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.34||||0.3065|TWO_SIDED|95.0|0.33|33.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.59|0.33|0.3065
91771444|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|19.9||||0.0056|TWO_SIDED|95.0|2.4|165.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||165.1|2.40|0.0056
91771445|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|25.05||||0.0027|TWO_SIDED|95.0|3.05|205.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||205.5|3.05|0.0027
91771446|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.61||||0.2762|TWO_SIDED|95.0|0.36|36.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||36.51|0.36|0.2762
91771447|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|6.93||||0.0851|TWO_SIDED|95.0|0.77|62.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||62.69|0.77|0.0851
91771448|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|17.02||||0.0081|TWO_SIDED|95.0|2.09|138.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||138.7|2.09|0.0081
91771449|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|6.37||||0.0995|TWO_SIDED|95.0|0.7|57.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||57.62|0.70|0.0995
91643328|NCT00448630|183178841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.544
91771450|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|5.76||||0.1184|TWO_SIDED|95.0|0.64|51.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||51.80|0.64|0.1184
91771451|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|26.54||||0.0023|TWO_SIDED|95.0|3.23|218.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||218.3|3.23|0.0023
91771452|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|19.09||||0.0062|TWO_SIDED|95.0|2.31|157.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||157.9|2.31|0.0062
91771453|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|7.49||||0.0695|TWO_SIDED|95.0|0.85|65.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||65.87|0.85|0.0695
91771454|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|8.64||||0.052|TWO_SIDED|95.0|0.98|75.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||75.98|0.98|0.0520
91771455|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|22.3||||0.0036|TWO_SIDED|95.0|2.75|180.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||180.6|2.75|0.0036
91771456|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0676|TWO_SIDED|95.0|0.89|24.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||24.23|0.89|0.0676
91771457|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.14||||0.0903|TWO_SIDED|95.0|0.8|21.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.38|0.80|0.0903
91771458|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|15.46||||0.0007|TWO_SIDED|95.0|3.18|75.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||75.14|3.18|0.0007
91771459|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|10.94||||0.0032|TWO_SIDED|95.0|2.22|53.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.77|2.22|0.0032
91771460|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.04||||0.2031|TWO_SIDED|95.0|0.55|16.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.85|0.55|0.2031
91771461|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.13||||0.0972|TWO_SIDED|95.0|0.77|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||22.10|0.77|0.0972
91771462|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|11.04||||0.0027|TWO_SIDED|95.0|2.3|53.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.06|2.30|0.0027
91771463|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.06||||0.1306|TWO_SIDED|95.0|0.72|13.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.02|0.72|0.1306
91771464|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0248|TWO_SIDED|95.0|1.22|19.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.10|1.22|0.0248
91771465|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|7.14||||0.0054|TWO_SIDED|95.0|1.79|28.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||28.53|1.79|0.0054
91771466|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|10.01||||0.001|TWO_SIDED|95.0|2.55|39.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||39.36|2.55|0.0010
91771467|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8271|TWO_SIDED|95.0|0.23|6.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.45|0.23|0.8271
91771468|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.27||||0.1089|TWO_SIDED|95.0|0.77|13.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.95|0.77|0.1089
91771469|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0138|TWO_SIDED|95.0|1.42|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||21.93|1.42|0.0138
91771470|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1987|TWO_SIDED|95.0|0.63|9.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.15|0.63|0.1987
91771471|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3984|TWO_SIDED|95.0|0.46|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.02|0.46|0.3984
91771472|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0402|TWO_SIDED|95.0|1.06|14.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.45|1.06|0.0402
91771473|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|8.05||||0.001|TWO_SIDED|95.0|2.32|27.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.95|2.32|0.0010
91771474|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8287|TWO_SIDED|95.0|0.17|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.08|0.17|0.8287
91771475|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.93||||0.1083|TWO_SIDED|95.0|0.79|10.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.92|0.79|0.1083
91771476|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0043|TWO_SIDED|95.0|1.76|20.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.66|1.76|0.0043
91771477|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.23||||0.1126|TWO_SIDED|95.0|0.76|13.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.79|0.76|0.1126
91771478|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.9||||0.1479|TWO_SIDED|95.0|0.69|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.30|0.69|0.1479
91771479|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|10.49||||0.001|TWO_SIDED|95.0|2.59|42.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.46|2.59|0.0010
91771480|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|13.01||||0.0002|TWO_SIDED|95.0|3.31|51.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.14|3.31|0.0002
91771481|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1483|TWO_SIDED|95.0|0.68|12.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.41|0.68|0.1483
91771482|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|4.03||||0.0557|TWO_SIDED|95.0|0.97|16.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.84|0.97|0.0557
91771483|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|6.47||||0.0072|TWO_SIDED|95.0|1.66|25.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.28|1.66|0.0072
91771484|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9715|TWO_SIDED|95.0|0.32|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.24|0.32|0.9715
91771485|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.49||||0.472|TWO_SIDED|95.0|0.5|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.39|0.50|0.4720
91643329|NCT00448630|183178842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.245
91771486|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1262|TWO_SIDED|95.0|0.79|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.05|0.79|0.1262
91771487|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0396|TWO_SIDED|95.0|1.05|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.92|1.05|0.0396
91771488|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5137|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.29|0.19|0.5137
91771489|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|2.25||||0.137|TWO_SIDED|95.0|0.77|6.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.58|0.77|0.1370
91771490|NCT03192176|183427584|SUPERIORITY||Odds Ratio (OR)|1.39||||0.5526|TWO_SIDED|95.0|0.47|4.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.07|0.47|0.5526
91771491|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0012|TWO_SIDED|95.0|1.99|16.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.62|1.99|0.0012
91771492|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.0001|TWO_SIDED|95.0|3.06|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.68|3.06|<0.0001
91771493|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.94|33.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.85|3.94|<0.0001
91771494|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|13.55|||<|0.0001|TWO_SIDED|95.0|4.55|40.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||40.38|4.55|<0.0001
91771495|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0555|TWO_SIDED|95.0|0.98|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.61|0.98|0.0555
91771496|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|7.98||||0.0001|TWO_SIDED|95.0|2.75|23.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.18|2.75|0.0001
91771497|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0001|TWO_SIDED|95.0|2.81|23.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.19|2.81|0.0001
91771498|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.55||||0.0012|TWO_SIDED|95.0|1.82|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.39|1.82|0.0012
91771499|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.25||||0.0005|TWO_SIDED|95.0|2.06|13.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.43|2.06|0.0005
91771500|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0003|TWO_SIDED|95.0|2.2|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.39|2.20|0.0003
91771501|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.0001|TWO_SIDED|95.0|2.99|23.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.74|2.99|<0.0001
91771502|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0277|TWO_SIDED|95.0|1.12|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.12|0.0277
91771503|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0022|TWO_SIDED|95.0|1.66|10.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.32|1.66|0.0022
91643330|NCT00448630|183178843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.362
91771504|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0314|TWO_SIDED|95.0|1.26|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.41|1.26|0.0314
91771505|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0041|TWO_SIDED|95.0|1.54|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.97|1.54|0.0041
91771506|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.19||||0.0028|TWO_SIDED|95.0|1.64|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.74|1.64|0.0028
91771507|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0011|TWO_SIDED|95.0|1.9|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.98|1.90|0.0011
91771508|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|8.79||||0.0001|TWO_SIDED|95.0|2.86|26.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||26.99|2.86|0.0001
91771509|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0036|TWO_SIDED|95.0|1.59|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.57|1.59|0.0036
91771510|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.52||||0.0018|TWO_SIDED|95.0|1.75|11.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.67|1.75|0.0018
91771511|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0243|TWO_SIDED|95.0|1.14|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.68|1.14|0.0243
91771512|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.33||||0.077|TWO_SIDED|95.0|0.91|5.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.96|0.91|0.0770
91771513|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0451|TWO_SIDED|95.0|1.02|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.69|1.02|0.0451
91771514|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0165|TWO_SIDED|95.0|1.25|9.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.04|1.25|0.0165
91771515|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0037|TWO_SIDED|95.0|1.72|16.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||16.23|1.72|0.0037
91771516|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0812|TWO_SIDED|95.0|0.9|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.90|0.0812
91771517|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0577|TWO_SIDED|95.0|0.97|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.22|0.97|0.0577
91771518|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0706|TWO_SIDED|95.0|0.93|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.85|0.93|0.0706
91771519|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0404|TWO_SIDED|95.0|1.04|7.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.00|1.04|0.0404
91771520|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0054|TWO_SIDED|95.0|1.54|11.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.99|1.54|0.0054
91771521|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0186|TWO_SIDED|95.0|1.22|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.27|1.22|0.0186
91771522|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|6.58||||0.0023|TWO_SIDED|95.0|1.96|22.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||22.14|1.96|0.0023
91771523|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0118|TWO_SIDED|95.0|1.33|9.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.93|1.33|0.0118
91771524|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.57||||0.002|TWO_SIDED|95.0|1.88|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.53|1.88|0.0020
91771525|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.71||||0.043|TWO_SIDED|95.0|1.03|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.14|1.03|0.0430
91771526|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2197|TWO_SIDED|95.0|0.7|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.66|0.70|0.2197
91771527|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1341|TWO_SIDED|95.0|0.8|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.42|0.80|0.1341
91771528|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0196|TWO_SIDED|95.0|1.23|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.05|1.23|0.0196
91771529|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0121|TWO_SIDED|95.0|1.41|16.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.26|1.41|0.0121
91771530|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1511|TWO_SIDED|95.0|0.77|5.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.56|0.77|0.1511
91771531|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.94||||0.0068|TWO_SIDED|95.0|1.55|15.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.68|1.55|0.0068
91771532|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0741|TWO_SIDED|95.0|0.91|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.79|0.91|0.0741
91771533|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2772|TWO_SIDED|95.0|0.65|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.43|0.65|0.2772
91771534|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0705|TWO_SIDED|95.0|0.92|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|0.92|0.0705
91771535|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.88||||0.022|TWO_SIDED|95.0|1.22|12.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.39|1.22|0.0220
91771536|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.33||||0.0196|TWO_SIDED|95.0|1.27|14.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.82|1.27|0.0196
91771537|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0433|TWO_SIDED|95.0|1.03|9.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.24|1.03|0.0433
91771538|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0355|TWO_SIDED|95.0|1.08|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.20|1.08|0.0355
91643331|NCT00448630|183178844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.176
91771539|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3238|TWO_SIDED|95.0|0.62|4.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.28|0.62|0.3238
91771540|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3208|TWO_SIDED|95.0|0.6|4.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.68|0.60|0.3208
91771541|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2281|TWO_SIDED|95.0|0.67|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.40|0.67|0.2281
91771542|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0566|TWO_SIDED|95.0|0.97|10.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.46|0.97|0.0566
91771543|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1491|TWO_SIDED|95.0|0.73|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.73|0.1491
91771544|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1477|TWO_SIDED|95.0|0.74|7.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.23|0.74|0.1477
91771545|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0532|TWO_SIDED|95.0|0.98|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.64|0.98|0.0532
91771546|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1616|TWO_SIDED|95.0|0.73|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.76|0.73|0.1616
91771547|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.5||||0.432|TWO_SIDED|95.0|0.55|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.11|0.55|0.4320
91771548|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2231|TWO_SIDED|95.0|0.68|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.35|0.68|0.2231
91771549|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.88||||0.0347|TWO_SIDED|95.0|1.1|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.64|1.10|0.0347
91771550|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0291|TWO_SIDED|95.0|1.17|18.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.07|1.17|0.0291
91771551|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2805|TWO_SIDED|95.0|0.61|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.38|0.61|0.2805
91771552|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0602|TWO_SIDED|95.0|0.95|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.11|0.95|0.0602
91771553|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5087|TWO_SIDED|95.0|0.51|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.88|0.51|0.5087
91771554|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1224|TWO_SIDED|95.0|0.8|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.38|0.80|0.1224
91771555|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.85||||0.228|TWO_SIDED|95.0|0.68|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.02|0.68|0.2280
91771556|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1835|TWO_SIDED|95.0|0.71|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.02|0.71|0.1835
91643332|NCT00448630|183178845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
91771557|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0107|TWO_SIDED|95.0|1.51|22.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.69|1.51|0.0107
91771558|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0576|TWO_SIDED|95.0|0.97|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.96|0.97|0.0576
91771559|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|9.68||||0.0047|TWO_SIDED|95.0|2.0|46.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.77|2.00|0.0047
91771560|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0569|TWO_SIDED|95.0|0.97|8.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.64|0.97|0.0569
91771561|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1078|TWO_SIDED|95.0|0.83|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.68|0.83|0.1078
91771562|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0772|TWO_SIDED|95.0|0.9|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.47|0.90|0.0772
91771563|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1311|TWO_SIDED|95.0|0.77|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.22|0.77|0.1311
91771564|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.64||||0.01255|TWO_SIDED|95.0|1.45|21.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||21.96|1.45|0.01255
91771565|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.97||||0.0128|TWO_SIDED|95.0|1.41|17.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.54|1.41|0.0128
91771566|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0079|TWO_SIDED|95.0|1.62|24.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||24.63|1.62|0.0079
91771567|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0572|TWO_SIDED|95.0|0.97|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.67|0.97|0.0572
91771568|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0284|TWO_SIDED|95.0|1.14|9.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.79|1.14|0.0284
91771569|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0705|TWO_SIDED|95.0|0.92|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.22|0.92|0.0705
91643333|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.524||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.524
91771570|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.81||||0.0136|TWO_SIDED|95.0|1.38|16.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.77|1.38|0.0136
91771571|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|9.96||||0.0043|TWO_SIDED|95.0|2.06|48.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||48.29|2.06|0.0043
91771572|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.66||||0.076|TWO_SIDED|95.0|0.9|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.83|0.90|0.0760
91771573|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0059|TWO_SIDED|95.0|1.65|20.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.00|1.65|0.0059
91771574|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|4.22||||0.0143|TWO_SIDED|95.0|1.33|13.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.35|1.33|0.0143
91643334|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91771575|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2779|TWO_SIDED|95.0|0.62|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.35|0.62|0.2779
91771576|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7559|TWO_SIDED|95.0|0.41|3.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.41|0.41|0.7559
91771577|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.07||||0.905|TWO_SIDED|95.0|0.35|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.23|0.35|0.9050
91771578|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2163|TWO_SIDED|95.0|0.66|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.38|0.66|0.2163
91771579|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1713|TWO_SIDED|95.0|0.7|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.14|0.70|0.1713
91771580|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3981|TWO_SIDED|95.0|0.52|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.09|0.52|0.3981
91771581|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9692|TWO_SIDED|95.0|0.35|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.96|0.35|0.9692
91771582|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.77||||0.2978|TWO_SIDED|95.0|0.6|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.22|0.60|0.2978
91771583|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8525|TWO_SIDED|95.0|0.38|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.38|0.8525
91771584|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5028|TWO_SIDED|95.0|0.21|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.13|0.21|0.5028
91771585|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4594|TWO_SIDED|95.0|0.5|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.73|0.50|0.4594
91771586|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1124|TWO_SIDED|95.0|0.8|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||8.17|0.80|0.1124
91771587|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3415|TWO_SIDED|95.0|0.55|5.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.58|0.55|0.3415
91771588|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3635|TWO_SIDED|95.0|0.56|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.83|0.56|0.3635
91771589|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5716|TWO_SIDED|95.0|0.24|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.24|0.5716
91771590|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5028|TWO_SIDED|95.0|0.23|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.23|0.5028
91771591|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3982|TWO_SIDED|95.0|0.18|1.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.98|0.18|0.3982
91771592|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.3|2.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.87|0.30|0.93
91771593|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|2.12||||0.2364|TWO_SIDED|95.0|0.61|7.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.32|0.61|0.2364
91771594|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7095|TWO_SIDED|95.0|0.39|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.04|0.39|0.7095
91771595|NCT03192176|183427585|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6011|TWO_SIDED|95.0|0.26|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.26|0.6011
91771596|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|6.78||||0.0181|TWO_SIDED|95.0|1.39|33.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.10|1.39|0.0181
91771597|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|9.97||||0.0039|TWO_SIDED|95.0|2.1|47.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.48|2.10|0.0039
91771598|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|21.2||||0.0001|TWO_SIDED|95.0|4.51|99.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||99.65|4.51|0.0001
91771599|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|23.97|||<|0.0001|TWO_SIDED|95.0|5.09|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||112.9|5.09|<0.0001
91771600|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.17||||0.1766|TWO_SIDED|95.0|0.59|16.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.87|0.59|0.1766
91771601|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|7.68||||0.0116|TWO_SIDED|95.0|1.58|37.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.43|1.58|0.0116
91771602|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|12.74||||0.0013|TWO_SIDED|95.0|2.71|59.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||59.81|2.71|0.0013
91771603|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0359|TWO_SIDED|95.0|1.07|7.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.43|1.07|0.0359
91771604|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.8||||0.0004|TWO_SIDED|95.0|2.2|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.33|2.20|0.0004
91771605|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|2.68|18.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.98|2.68|<0.0001
91771606|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|6.84||||0.0001|TWO_SIDED|95.0|2.53|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.53|0.0001
91771607|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.04||||0.154|TWO_SIDED|95.0|0.76|5.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.47|0.76|0.1540
91771608|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.84||||0.0065|TWO_SIDED|95.0|1.46|10.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.12|1.46|0.0065
91771609|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0052|TWO_SIDED|95.0|1.5|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.14|1.50|0.0052
91771610|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0064|TWO_SIDED|95.0|1.44|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.39|1.44|0.0064
91771611|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0003|TWO_SIDED|95.0|2.26|15.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.21|2.26|0.0003
91771612|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0001|TWO_SIDED|95.0|2.47|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.69|2.47|0.0001
91771613|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|8.21|||<|0.0001|TWO_SIDED|95.0|3.01|22.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||22.42|3.01|<0.0001
91643335|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.005
91771614|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0171|TWO_SIDED|95.0|1.22|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.97|1.22|0.0171
91771615|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.38||||0.002|TWO_SIDED|95.0|1.71|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.18|1.71|0.0020
91771616|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0034|TWO_SIDED|95.0|1.58|9.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.99|1.58|0.0034
91771617|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0399|TWO_SIDED|95.0|1.05|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.59|1.05|0.0399
91771618|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0003|TWO_SIDED|95.0|2.23|14.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.84|2.23|0.0003
91771619|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.05||||0.0031|TWO_SIDED|95.0|1.6|10.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.23|1.60|0.0031
91771620|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.41|28.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.28|3.41|<0.0001
91771621|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0036|TWO_SIDED|95.0|1.57|10.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.01|1.57|0.0036
91771622|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0009|TWO_SIDED|95.0|1.89|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.11|1.89|0.0009
91643336|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91771623|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0091|TWO_SIDED|95.0|1.35|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.21|1.35|0.0091
91771624|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2043|TWO_SIDED|95.0|0.73|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.34|0.73|0.2043
91771625|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0012|TWO_SIDED|95.0|1.84|12.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.01|1.84|0.0012
91771626|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0058|TWO_SIDED|95.0|1.47|9.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.70|1.47|0.0058
91771627|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0002|TWO_SIDED|95.0|2.73|23.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||23.83|2.73|0.0002
91771628|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0221|TWO_SIDED|95.0|1.16|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.12|1.16|0.0221
91771629|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0034|TWO_SIDED|95.0|1.58|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.13|1.58|0.0034
91643337|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.009
91643338|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91771630|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.04|1.29|0.0123
91771631|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.56||||0.3291|TWO_SIDED|95.0|0.64|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.78|0.64|0.3291
91771632|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0118|TWO_SIDED|95.0|1.3|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.21|1.30|0.0118
91771633|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.93||||0.0058|TWO_SIDED|95.0|1.49|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.40|1.49|0.0058
91771634|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.98||||0.0012|TWO_SIDED|95.0|2.03|17.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||17.65|2.03|0.0012
91771635|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1043|TWO_SIDED|95.0|0.85|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.32|0.85|0.1043
91771636|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0015|TWO_SIDED|95.0|1.85|13.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||13.54|1.85|0.0015
91771637|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0658|TWO_SIDED|95.0|0.95|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.73|0.95|0.0658
91771638|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1253|TWO_SIDED|95.0|0.82|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.98|0.82|0.1253
91771639|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0013|TWO_SIDED|95.0|1.88|13.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.34|1.88|0.0013
91771640|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0096|TWO_SIDED|95.0|1.37|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.75|1.37|0.0096
91771641|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|6.06||||0.0012|TWO_SIDED|95.0|2.04|17.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||17.96|2.04|0.0012
91771642|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0344|TWO_SIDED|95.0|1.08|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|1.08|0.0344
91771643|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0045|TWO_SIDED|95.0|1.55|10.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.72|1.55|0.0045
91771644|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.24||||0.081|TWO_SIDED|95.0|0.91|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.55|0.91|0.0810
91771645|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0761|TWO_SIDED|95.0|0.92|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.70|0.92|0.0761
91771646|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0078|TWO_SIDED|95.0|1.41|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.51|1.41|0.0078
91771647|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0253|TWO_SIDED|95.0|1.15|7.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.82|1.15|0.0253
91643339|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.047
91771648|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|6.23||||0.0017|TWO_SIDED|95.0|1.99|19.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.55|1.99|0.0017
91771649|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3512|TWO_SIDED|95.0|0.62|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.87|0.62|0.3512
91771650|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0352|TWO_SIDED|95.0|1.07|7.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.13|1.07|0.0352
91771651|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.36||||0.0704|TWO_SIDED|95.0|0.93|5.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.97|0.93|0.0704
91771652|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.94||||0.1651|TWO_SIDED|95.0|0.76|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.76|0.1651
91771653|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0964|TWO_SIDED|95.0|0.87|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.62|0.87|0.0964
91771654|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0276|TWO_SIDED|95.0|1.13|8.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.59|1.13|0.0276
91771655|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.99||||0.006|TWO_SIDED|95.0|1.58|15.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.70|1.58|0.0060
91771656|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1556|TWO_SIDED|95.0|0.76|5.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.39|0.76|0.1556
91771657|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0202|TWO_SIDED|95.0|1.21|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.18|1.21|0.0202
91771658|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2063|TWO_SIDED|95.0|0.72|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.67|0.72|0.2063
91771659|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0383|TWO_SIDED|95.0|1.06|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.92|1.06|0.0383
91771660|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0118|TWO_SIDED|95.0|1.32|9.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.10|1.32|0.0118
91771661|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0314|TWO_SIDED|95.0|1.1|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.97|1.10|0.0314
91771662|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|6.8||||0.001|TWO_SIDED|95.0|2.17|21.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.34|2.17|0.0010
91771663|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0956|TWO_SIDED|95.0|0.87|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.80|0.87|0.0956
91771664|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0027|TWO_SIDED|95.0|1.72|13.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.40|1.72|0.0027
91771665|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.41||||0.066|TWO_SIDED|95.0|0.94|6.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.14|0.94|0.0660
91643340|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0007
91643341|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0057||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0057
91771666|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0853|TWO_SIDED|95.0|0.89|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.05|0.89|0.0853
91771667|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0159|TWO_SIDED|95.0|1.26|9.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.62|1.26|0.0159
91771668|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0303|TWO_SIDED|95.0|1.12|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.53|1.12|0.0303
91771669|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.84||||0.0071|TWO_SIDED|95.0|1.54|15.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||15.28|1.54|0.0071
91771670|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0621|TWO_SIDED|95.0|0.95|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.95|0.0621
91771671|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0081|TWO_SIDED|95.0|1.45|12.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.15|1.45|0.0081
91771672|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0533|TWO_SIDED|95.0|0.99|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.99|0.0533
91771673|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.71||||0.2666|TWO_SIDED|95.0|0.66|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.42|0.66|0.2666
91771674|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0754|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.52|0.91|0.0754
91771675|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0313|TWO_SIDED|95.0|1.11|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.64|1.11|0.0313
91518616|NCT00675766|182911576|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.||Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.005
91771676|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0056|TWO_SIDED|95.0|1.67|19.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||19.88|1.67|0.0056
91771677|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0736|TWO_SIDED|95.0|0.91|7.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.28|0.91|0.0736
91771678|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0184|TWO_SIDED|95.0|1.24|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||10.00|1.24|0.0184
91771679|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1187|TWO_SIDED|95.0|0.82|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.81|0.82|0.1187
91771680|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0299|TWO_SIDED|95.0|1.14|12.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.69|1.14|0.0299
91771681|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5989|TWO_SIDED|95.0|0.4|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.89|0.40|0.5989
91643342|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
91643343|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0201||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0201
91706185|NCT00938587|183306679|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
91706186|NCT00938587|183306679|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
91771682|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1337|TWO_SIDED|95.0|0.74|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.14|0.74|0.1337
91771683|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4605|TWO_SIDED|95.0|0.45|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.89|0.45|0.4605
91771684|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0188|TWO_SIDED|95.0|1.28|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||15.65|1.28|0.0188
91771685|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5854|TWO_SIDED|95.0|0.39|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.39|0.5854
91771686|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1768|TWO_SIDED|95.0|0.68|7.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.86|0.68|0.1768
91771687|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8426|TWO_SIDED|95.0|0.29|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.78|0.29|0.8426
91771688|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3017|TWO_SIDED|95.0|0.17|1.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.73|0.17|0.3017
91771689|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5958|TWO_SIDED|95.0|0.21|2.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.43|0.21|0.5958
91771690|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.23||||0.0515|TWO_SIDED|95.0|0.05|1.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.01|0.05|0.0515
91643344|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0095||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0095
91643345|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0386
91771691|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9734|TWO_SIDED|95.0|0.31|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.11|0.31|0.9734
91771692|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7969|TWO_SIDED|95.0|0.25|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.93|0.25|0.7969
91771693|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6637|TWO_SIDED|95.0|0.25|2.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.40|0.25|0.6637
91771694|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4921|TWO_SIDED|95.0|0.45|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.15|0.45|0.4921
91771695|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.09||||0.891|TWO_SIDED|95.0|0.33|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.64|0.33|0.8910
91771696|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5881|TWO_SIDED|95.0|0.16|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.78|0.16|0.5881
91643346|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1976
91643347|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2383||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2383
91643348|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||2e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00002
91643349|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8297||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8297
91643350|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9081||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9081
91643351|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7386
91643352|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
91771697|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.11||||0.0523|TWO_SIDED|95.0|0.01|1.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.02|0.01|0.0523
91771698|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4646|TWO_SIDED|95.0|0.46|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.61|0.46|0.4646
91771699|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5806|TWO_SIDED|95.0|0.4|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.14|0.40|0.5806
91771700|NCT03192176|183427586|SUPERIORITY||Odds Ratio (OR)|0.94||||0.922|TWO_SIDED|95.0|0.28|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.12|0.28|0.9220
91771701|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.45||||0.1933|TWO_SIDED|95.0|0.47|42.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||42.25|0.47|0.1933
91771702|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.61||||0.124|TWO_SIDED|95.0|0.62|50.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||50.44|0.62|0.1240
91771703|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|14.16||||0.014|TWO_SIDED|95.0|1.71|117.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||117.2|1.71|0.0140
91771704|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|17.5||||0.0075|TWO_SIDED|95.0|2.15|142.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||142.7|2.15|0.0075
91771705|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.98||||0.5853|TWO_SIDED|95.0|0.17|22.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.96|0.17|0.5853
91771706|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.0||||0.1596|TWO_SIDED|95.0|0.53|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.05|0.53|0.1596
91771707|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.48||||0.0908|TWO_SIDED|95.0|0.74|56.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||56.51|0.74|0.0908
91643353|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2587
91771708|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.97||||0.1318|TWO_SIDED|95.0|0.72|12.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.19|0.72|0.1318
91771709|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0093|TWO_SIDED|95.0|1.56|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.04|1.56|0.0093
91771710|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|10.13||||0.0006|TWO_SIDED|95.0|2.69|38.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||38.22|2.69|0.0006
91771711|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|15.63|||<|0.0001|TWO_SIDED|95.0|4.11|59.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||59.40|4.11|<0.0001
91771712|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.53||||0.2054|TWO_SIDED|95.0|0.6|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.64|0.60|0.2054
91771713|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1592|TWO_SIDED|95.0|0.67|11.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.72|0.67|0.1592
91771714|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.31||||0.007|TWO_SIDED|95.0|1.66|24.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||24.07|1.66|0.0070
91643354|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6263||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6263
91643355|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
91643356|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2589||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2589
91771715|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0392|TWO_SIDED|95.0|1.06|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|1.06|0.0392
91771716|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0096|TWO_SIDED|95.0|1.44|13.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.96|1.44|0.0096
91771717|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|10.11|||<|0.0001|TWO_SIDED|95.0|3.28|31.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||31.16|3.28|<0.0001
91771718|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.0001|TWO_SIDED|95.0|3.75|36.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.90|3.75|<0.0001
91771719|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.11||||0.2217|TWO_SIDED|95.0|0.64|7.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.03|0.64|0.2217
91771720|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0131|TWO_SIDED|95.0|1.36|13.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.38|1.36|0.0131
91771721|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.46|1.76|0.0031
91771722|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1485|TWO_SIDED|95.0|0.76|6.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.10|0.76|0.1485
91771723|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0128|TWO_SIDED|95.0|1.31|9.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.56|1.31|0.0128
91771724|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.5||||0.0003|TWO_SIDED|95.0|2.37|17.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.81|2.37|0.0003
91643357|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5153||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5153
91771725|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.32|17.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.77|2.32|0.0003
91771726|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.87||||0.2354|TWO_SIDED|95.0|0.67|5.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.26|0.67|0.2354
91771727|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0894|TWO_SIDED|95.0|0.87|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.65|0.87|0.0894
91771728|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0201|TWO_SIDED|95.0|1.2|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.67|1.20|0.0201
91771729|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1614|TWO_SIDED|95.0|0.74|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.94|0.74|0.1614
91771730|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0123|TWO_SIDED|95.0|1.32|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.66|1.32|0.0123
91771731|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0006|TWO_SIDED|95.0|2.17|17.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.03|2.17|0.0006
91643358|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0003
91643359|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0005
91643360|NCT00448630|183178846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8952||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8952
91771732|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.4|28.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||28.36|3.40|<0.0001
91771733|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1609|TWO_SIDED|95.0|0.75|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.75|0.1609
91771734|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.42||||0.093|TWO_SIDED|95.0|0.86|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.79|0.86|0.0930
91771735|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0063|TWO_SIDED|95.0|1.48|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.91|1.48|0.0063
91771736|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2621|TWO_SIDED|95.0|0.65|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.74|0.65|0.2621
91771737|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0092|TWO_SIDED|95.0|1.37|9.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.21|1.37|0.0092
91771738|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.69||||0.0007|TWO_SIDED|95.0|2.09|15.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.48|2.09|0.0007
91771739|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.0001|TWO_SIDED|95.0|3.08|25.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||25.43|3.08|<0.0001
91771740|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4259|TWO_SIDED|95.0|0.55|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.08|0.55|0.4259
91771741|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1334|TWO_SIDED|95.0|0.79|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.74|0.79|0.1334
91771742|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.39||||0.012|TWO_SIDED|95.0|1.31|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.77|1.31|0.0120
91771743|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2443|TWO_SIDED|95.0|0.66|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.10|0.66|0.2443
91771744|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0022|TWO_SIDED|95.0|1.73|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.25|1.73|0.0022
91706187|NCT00938587|183306679|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
91771745|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.6||||0.0004|TWO_SIDED|95.0|2.35|18.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.58|2.35|0.0004
91771746|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|12.17|||<|0.0001|TWO_SIDED|95.0|4.05|36.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||36.63|4.05|<0.0001
91771747|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3101|TWO_SIDED|95.0|0.61|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.71|0.61|0.3101
91771748|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0116|TWO_SIDED|95.0|1.34|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.00|1.34|0.0116
91706188|NCT00938587|183306679|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
91771749|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0045|TWO_SIDED|95.0|1.56|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.05|1.56|0.0045
91771750|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3505|TWO_SIDED|95.0|0.62|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.88|0.62|0.3505
91771751|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0739|TWO_SIDED|95.0|0.92|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.62|0.92|0.0739
91771752|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0163|TWO_SIDED|95.0|1.24|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.20|1.24|0.0163
91771753|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0001|TWO_SIDED|95.0|2.81|25.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||25.64|2.81|0.0001
91771754|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8358|TWO_SIDED|95.0|0.35|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.35|0.35|0.8358
91771755|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1006|TWO_SIDED|95.0|0.86|5.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.52|0.86|0.1006
91771756|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0484|TWO_SIDED|95.0|1.01|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.34|1.01|0.0484
91771757|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6492|TWO_SIDED|95.0|0.5|3.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.08|0.50|0.6492
91643361|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.197
91771758|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.74||||0.223|TWO_SIDED|95.0|0.71|4.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.27|0.71|0.2230
91771759|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0126|TWO_SIDED|95.0|1.3|9.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.02|1.30|0.0126
91771760|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.56||||0.0014|TWO_SIDED|95.0|1.94|15.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.98|1.94|0.0014
91771761|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|0.7||||0.4713|TWO_SIDED|95.0|0.27|1.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||1.83|0.27|0.4713
91643362|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.010
91643363|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.012
91771762|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1397|TWO_SIDED|95.0|0.79|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.12|0.79|0.1397
91771763|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2272|TWO_SIDED|95.0|0.71|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.34|0.71|0.2272
91706189|NCT00938587|183306679|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0477|TWO_SIDED|90.0|0.23|32.92|||Barnard exact test|||Day 14||32.92|0.23|0.0477
91643364|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91643365|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.282
91643366|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.040
91643367|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.004
91643368|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0193
91643369|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0065
91643370|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
91643371|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3172||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3172
91643372|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0116
91643373|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0016
91643374|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2600
91643375|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2309||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2309
91643376|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0063
91643377|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8158||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8158
91643378|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3968
91643379|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7193
91643380|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
91643381|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2351
91643382|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5672||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5672
91643383|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
91643384|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1774
91643385|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6082||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6082
91643386|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
91643387|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0014
91643388|NCT00448630|183178847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5587
91643389|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.077
91643390|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.039
91643391|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.978
91706190|NCT00938587|183306679|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0442|TWO_SIDED|90.0|0.65|32.92|||Barnard exact test|||Day 14||32.92|0.65|0.0442
91643392|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
91643393|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.593
91643394|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.987
91643395|NCT00448630|183178848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.174
91643396|NCT04662086|183178849|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
91706191|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5403|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5403
91654913|NCT00936975|183202608|SUPERIORITY_OR_OTHER||Slope|6.98|STANDARD_ERROR_OF_MEAN|1.6943|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: No difference in uptake b/w normal \& tumor bones||||<0.001
91643397|NCT04662086|183178850|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
91643398|NCT04662086|183178852|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
91643399|NCT04662086|183178853|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
91643400|NCT04662086|183178854|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
91643401|NCT01687400|183178856|OTHER|||||||0.035|||||||Fisher Exact|||Statistical analysis #1 is for the genetic mutation TP53.||||0.035
91643402|NCT01687400|183178856|OTHER|||||||0.72|||||||Fisher Exact|||Statistical analysis #2 is for ASXL1 genetic mutation||||0.72
91643403|NCT01687400|183178856|OTHER|||||||0.28|||||||Fisher Exact|||Statistical analysis #3 is for SRSF2 genetic mutation||||0.28
91643404|NCT01687400|183178856|OTHER|||||||0.14|||||||Fisher Exact|||Statistical analysis #4 is for IDH2 genetic mutation||||0.14
91643405|NCT01687400|183178856|OTHER|||||||0.3|||||||Fisher Exact|||Statistical analysis #5 is for DNMT3A genetic mutation||||0.3
91643406|NCT01687400|183178856|OTHER|||||||0.183|||||||Fisher Exact|||Statistical analysis #6 is for SF3B1 genetic mutation||||0.183
91643407|NCT01687400|183178856|OTHER|||||||0.42|||||||Fisher Exact|||Statistical analysis #7 is for RUNX1 genetic mutation||||0.42
91643408|NCT01687400|183178856|OTHER|||||||0.36|||||||Fisher Exact|||Statistical analysis #8 is for TET2 genetic mutation||||0.36
91643409|NCT01687400|183178856|OTHER|||||||0.1|||||||Fisher Exact|||Statistical analysis #9 is for IDH1 genetic mutation||||0.1
91643410|NCT01687400|183178856|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #10 is for NPM1 genetic mutation||||1
91643411|NCT01687400|183178856|OTHER|||||||0.17|||||||Fisher Exact|||Statistical analysis #11 is for NRAS genetic mutation||||0.17
91643412|NCT01687400|183178856|OTHER|||||||1|||||||Fisher Exact|||-Statistical analysis #12 is for U2AF1 genetic mutation||||1
91643413|NCT01687400|183178856|OTHER|||||||0.6|||||||Fisher Exact|||Statistical analysis #13 is for MY05B genetic mutation||||0.6
91643414|NCT01687400|183178856|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #14 is for WT1 genetic mutation||||1
91643415|NCT01687400|183178857|SUPERIORITY||Overall Response Rate-for current study|0.744|||<|0.0001|TWO_SIDED|95.0|0.652|0.836|||Chi-squared|1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate||0.836|0.652|<0.0001
91643416|NCT01687400|183178857|SUPERIORITY||Complete response rate-for current study|0.64|||<|0.0001|TWO_SIDED|95.0|0.538|0.741|||Chi-squared|1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.||0.741|0.538|<0.0001
91643417|NCT04253756|183178870|NON_INFERIORITY|The margin of non-inferiority (Delta) was 5g/dl|Mean Difference (Final Values)|0.5||||0.87|TWO_SIDED||||||ANOVA|||||||0.87
91643418|NCT04253756|183178871|NON_INFERIORITY|The non-inferiority margin (Delta) was 10 minutes of run time, no other key parameters|Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
91643419|NCT03731325|183178875|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.01|TWO_SIDED||||||ANOVA||This mean difference represents the main effect of time from baseline to 15 weeks, regardless of group|Change in parent BMI from baseline at 8,11 to 15 weeks||||<0.01
91643420|NCT03731325|183178876|SUPERIORITY||Mean Difference (Net)|-10.5||||0.003|TWO_SIDED|||||main effect of time|ANOVA||This is the main effect of weight change at week 15, e.g. average weight change from baseline to week 15 in the entire sample of parents|repeated measures analysis of variance for time (0,8,11,15 weeks) for weight change (lbs)||||0.003
91643421|NCT03731325|183178877|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.06|TWO_SIDED||||||ANOVA||average difference in BMI percentile for entire sample|Repeated measures ANOVA for child BMI percentile at 0, 8, 11 and 15 weeks||||0.06
91643422|NCT03731325|183178878|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.07|TWO_SIDED||||||ANOVA||average change in delay discounting measure area under the curve for all participants (parents and children) in both groups from baseline to week 15|repeated measures ANOVA, reporting repeated measures effect only||||0.07
91643423|NCT03731325|183178879|SUPERIORITY||Mean Difference (Net)|-0.8||||0.64|TWO_SIDED||||||ANOVA||Difference between weight at baseline and week 15 in lbs for all children, regardless of group|||||0.64
91643424|NCT00539006|183178890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0|-1.5|-0.6|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo|FFNS combined across treatment arms 1 \& 2 compared with Placebo FFNS combined across treatment arms 1 \& 2.||-0.6|-1.5|<0.001
91643425|NCT00539006|183178890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|-1.1|-0.2|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo|FPNS combined across treatment arms 1 \& 2 compared with Placebo FPNS combined across treatment arms 1 \& 2.||-0.2|-1.1|0.004
91643426|NCT00539006|183178891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximation to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||Statistical analysis applies to FFNS and FPNS categories.||||<0.001
91643427|NCT03733301|183178895|SUPERIORITY||Odds Ratio (OR)|1.88||||0.082|TWO_SIDED|95.0|0.92|3.85|||Regression, Logistic|||||3.85|0.92|0.082
91643428|NCT03733301|183178895|SUPERIORITY||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.38|5.56|||Regression, Logistic|||||5.56|1.38|0.004
91643429|NCT03733301|183178896|SUPERIORITY||Odds Ratio (OR)|2.62||||0.002|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||||4.76|1.44|0.002
91643430|NCT03733301|183178896|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.8|5.97|||Regression, Logistic|||||5.97|1.80|< 0.001
91643431|NCT03733301|183178897|SUPERIORITY||Odds Ratio (OR)|1.24||||0.574|TWO_SIDED|95.0|0.59|2.62|||Regression, Logistic|||||2.62|0.59|0.574
91643432|NCT03733301|183178897|SUPERIORITY||Odds Ratio (OR)|2.07||||0.045|TWO_SIDED|95.0|1.02|4.2|||Regression, Logistic|||||4.20|1.02|0.045
91643433|NCT03733301|183178898|SUPERIORITY||Mean Difference (Final Values)|-13.08|STANDARD_ERROR_OF_MEAN|5.256||0.013|TWO_SIDED|95.0|-23.42|-2.73|||Mixed Models Analysis|||||-2.73|-23.42|0.013
91643434|NCT03733301|183178898|SUPERIORITY||Mean Difference (Final Values)|-22.13|STANDARD_ERROR_OF_MEAN|5.259|<|0.001|TWO_SIDED|95.0|-32.48|-11.78|||Mixed Models Analysis|||||-11.78|-32.48|<0.001
91643435|NCT03733301|183178899|SUPERIORITY||Odds Ratio (OR)|1.53||||0.364|TWO_SIDED|95.0|0.61|3.81|||Regression, Logistic|||||3.81|0.61|0.364
91643436|NCT03733301|183178899|SUPERIORITY||Odds Ratio (OR)|2.7||||0.022|TWO_SIDED|95.0|1.15|6.34|||Regression, Logistic|||||6.34|1.15|0.022
91643437|NCT03733301|183178900|SUPERIORITY||Odds Ratio (OR)|2.88||||0.002|TWO_SIDED|95.0|1.48|5.61|||Regression, Logistic|||||5.61|1.48|0.002
91643438|NCT03733301|183178900|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|1.98|7.46|||Regression, Logistic|||||7.46|1.98|<0.001
91643439|NCT03733301|183178901|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.23|-0.41|||Mixed Models Analysis|||||-0.41|-1.23|<0.001
91643440|NCT03733301|183178901|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||||-0.51|-1.33|<0.001
91643441|NCT03733301|183178902|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.319|<|0.001|TWO_SIDED|95.0|-1.78|-0.52|||Mixed Models Analysis|||||-0.52|-1.78|<0.001
91643442|NCT03733301|183178902|SUPERIORITY||Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-2.3|-1.3|||Mixed Models Analysis|||||-1.30|-2.30|<0.001
91643443|NCT03733301|183178903|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.001|TWO_SIDED|95.0|1.47|4.49|||Regression, Logistic|||||4.49|1.47|<0.001
91643444|NCT03733301|183178903|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|2.0|6.32|||Regression, Logistic|||||6.32|2.00|<0.001
91643445|NCT03733301|183178904|SUPERIORITY||Odds Ratio (OR)|1.3||||0.715|TWO_SIDED|95.0|0.32|5.31|||Regression, Logistic|||||5.31|0.32|0.715
91643446|NCT03733301|183178904|SUPERIORITY||Odds Ratio (OR)|3.02||||0.083|TWO_SIDED|95.0|0.86|10.56|||Regression, Logistic|||||10.56|0.86|0.083
91643447|NCT03733301|183178905|SUPERIORITY||Mean Difference (Final Values)|-8.48|STANDARD_ERROR_OF_MEAN|2.663||0.002|TWO_SIDED|95.0|-13.72|-3.24|||Mixed Models Analysis|||||-3.24|-13.72|0.002
91643448|NCT03733301|183178905|SUPERIORITY||Mean Difference (Final Values)|-14.38|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-19.62|-9.14|||Mixed Models Analysis|||||-9.14|-19.62|<0.001
91643449|NCT03733301|183178906|SUPERIORITY||Odds Ratio (OR)|3.21||||0.204|TWO_SIDED|95.0|0.53|19.37|||Regression, Logistic|||||19.37|0.53|0.204
91643450|NCT03733301|183178906|SUPERIORITY||Odds Ratio (OR)|6.99||||0.025|TWO_SIDED|95.0|1.27|38.53|||Regression, Logistic|||||38.53|1.27|0.025
91643451|NCT03733301|183178907|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.591|<|0.001|TWO_SIDED|95.0|-14.07|-3.87|||Mixed Models Analysis|||||-3.87|-14.07|<0.001
91643452|NCT03733301|183178907|SUPERIORITY||Mean Difference (Final Values)|-11.69|STANDARD_ERROR_OF_MEAN|2.584|<|0.001|TWO_SIDED|95.0|-16.78|-6.61|||Mixed Models Analysis|||||-6.61|-16.78|<0.001
91643453|NCT03733301|183178908|SUPERIORITY|||||||0.721|||||||Fisher Exact|||||||0.721
91643454|NCT03733301|183178908|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91643455|NCT03733301|183178909|SUPERIORITY||Mean Difference (Final Values)|-65.16|STANDARD_ERROR_OF_MEAN|24.149||0.0073|TWO_SIDED|95.0|-112.87|-17.65|||ANOVA|||||-17.65|-112.87|0.0073
91643456|NCT03733301|183178909|SUPERIORITY||Mean Difference (Final Values)|-91.14|STANDARD_ERROR_OF_MEAN|24.038||0.0002|TWO_SIDED|95.0|-138.43|-43.85|||ANOVA|||||-43.85|-138.43|0.0002
91643457|NCT03733301|183178910|SUPERIORITY||Mean Difference (Final Values)|-16.44|STANDARD_ERROR_OF_MEAN|4.658|<|0.001|TWO_SIDED|95.0|-25.6|-7.27|||Mixed Models Analysis|||||-7.27|-25.60|< 0.001
91643458|NCT03733301|183178910|SUPERIORITY||Mean Difference (Final Values)|-24.22|STANDARD_ERROR_OF_MEAN|4.672|<|0.001|TWO_SIDED|95.0|-33.42|-15.03|||Mixed Models Analysis|||||-15.03|-33.42|< 0.001
91643459|NCT03733301|183178911|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.046||0.006|TWO_SIDED|95.0|-4.96|-0.84|||Mixed Models Analysis|||||-0.84|-4.96|0.006
91643460|NCT03733301|183178911|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|1.043|<|0.001|TWO_SIDED|95.0|-7.28|-3.18|||Mixed Models Analysis|||||-3.18|-7.28|< 0.001
91643461|NCT03733301|183178912|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.005|TWO_SIDED|95.0|-0.63|-0.12|||Mixed Models Analysis|||||-0.12|-0.63|0.005
91643462|NCT03733301|183178912|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.75|-0.24|||Mixed Models Analysis|||||-0.24|-0.75|< 0.001
91643463|NCT03733301|183178913|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.425||0.083|TWO_SIDED|95.0|-1.57|0.1|||Mixed Models Analysis|||HADS Depression||0.10|-1.57|0.083
91643464|NCT03733301|183178913|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.423||0.016|TWO_SIDED|95.0|-1.85|-0.19|||Mixed Models Analysis|||HADS Depression||-0.19|-1.85|0.016
91643465|NCT03733301|183178913|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.415||0.051|TWO_SIDED|95.0|-1.63|0.0|||Mixed Models Analysis|||HADS Anxiety||0.00|-1.63|0.051
91643466|NCT03733301|183178913|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.413||0.028|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.72|0.028
91643467|NCT03733301|183178914|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.832||0.022|TWO_SIDED|95.0|-3.56|-0.28|||Mixed Models Analysis|||||-0.28|-3.56|0.022
91643468|NCT03733301|183178914|SUPERIORITY||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.829|<|0.001|TWO_SIDED|95.0|-4.94|-1.68|||Mixed Models Analysis|||||-1.68|-4.94|< 0.001
91643469|NCT03733301|183178915|SUPERIORITY||Mean Difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.569||0.435|TWO_SIDED|95.0|-3.06|7.08|||Mixed Models Analysis|||Absenteeism||7.08|-3.06|0.435
91643470|NCT03733301|183178915|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.569||0.706|TWO_SIDED|95.0|-4.1|6.04|||Mixed Models Analysis|||Absenteeism||6.04|-4.10|0.706
91643471|NCT03733301|183178915|SUPERIORITY|Presenteeism|Mean Difference (Final Values)|-8.12|STANDARD_ERROR_OF_MEAN|4.384||0.066|TWO_SIDED|95.0|-16.78|0.54|||Mixed Models Analysis|||||0.54|-16.78|0.066
91643472|NCT03733301|183178915|SUPERIORITY||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|4.336||0.014|TWO_SIDED|95.0|-19.3|-2.17|||Mixed Models Analysis|||Presenteeism||-2.17|-19.30|0.014
91643473|NCT03733301|183178915|SUPERIORITY|Work Productivity Loss|Mean Difference (Final Values)|-7.93|STANDARD_ERROR_OF_MEAN|4.511||0.081|TWO_SIDED|95.0|-16.84|0.99|||Mixed Models Analysis|||||0.99|-16.84|0.081
91643474|NCT03733301|183178915|SUPERIORITY||Mean Difference (Final Values)|-10.71|STANDARD_ERROR_OF_MEAN|4.473||0.018|TWO_SIDED|95.0|-19.55|1.88|||Mixed Models Analysis|||Work productivity Loss||1.88|-19.55|0.018
91643475|NCT03733301|183178915|SUPERIORITY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|3.511||0.006|TWO_SIDED|95.0|-16.71|-2.89|||Mixed Models Analysis|||Activity Impairment||-2.89|-16.71|0.006
91643476|NCT03733301|183178915|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.39|-3.61|||Mixed Models Analysis|||Activity Impairment||-3.61|-17.39|0.003
91643477|NCT03733301|183178916|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.176|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Health State Index US||0.06|-0.01|0.176
91643478|NCT03733301|183178916|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.017||0.004|TWO_SIDED|95.0|0.02|0.09|||Mixed Models Analysis|||Health State Index US||0.09|0.02|0.004
91643479|NCT03733301|183178916|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.024||0.176|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||Health State Index UK||0.08|-0.01|0.176
91643480|NCT03733301|183178916|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.024||0.003|TWO_SIDED|95.0|0.02|0.12|||Mixed Models Analysis|||Health State Index UK||0.12|0.02|0.003
91643481|NCT03733301|183178917|SUPERIORITY||Mean Difference (Final Values)|4.12|STANDARD_ERROR_OF_MEAN|2.593||0.113|TWO_SIDED|95.0|-0.98|9.23|||Mixed Models Analysis|||||9.23|-0.98|0.113
91643482|NCT03733301|183178917|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|2.592||0.02|TWO_SIDED|95.0|0.96|11.16|||Mixed Models Analysis|||||11.16|0.96|0.020
91643483|NCT03733301|183178918|SUPERIORITY||Mean Difference (Final Values)|10.04|STANDARD_ERROR_OF_MEAN|4.36||0.022|TWO_SIDED|95.0|1.46|18.36|||ANCOVA|||||18.36|1.46|0.022
91643484|NCT03733301|183178918|SUPERIORITY||Mean Difference (Final Values)|17.33|STANDARD_ERROR_OF_MEAN|4.34|<|0.001|TWO_SIDED|95.0|8.79|25.88|||ANCOVA|||||25.88|8.79|< 0.001
91643485|NCT03733301|183178919|SUPERIORITY||Odds Ratio (OR)|3.83||||0.006|TWO_SIDED|95.0|1.46|10.03|||Regression, Logistic|||||10.03|1.46|0.006
91643486|NCT03733301|183178919|SUPERIORITY||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.77|11.87|||Regression, Logistic|||||11.87|1.77|0.002
91643487|NCT01965431|183178920|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.|Mean Difference (Net)|7.9|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|5.37|10.43|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|||10.43|5.37|
91643488|NCT01965431|183178921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|90.0|9.32|16.08|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||16.08|9.32|
91643489|NCT01965431|183178922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-1.38|1.73|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||1.73|-1.38|
91643490|NCT01965431|183178923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.42|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-5.98|-2.87|||||Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||-2.87|-5.98|
91643491|NCT04636437|183178951|SUPERIORITY||Mean Difference (Net)|1.36||||0.23|TWO_SIDED|97.5|-1.2|3.92||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||3.92|-1.20|0.23
91643492|NCT04636437|183178951|SUPERIORITY||Mean Difference (Net)|-0.89||||0.41|TWO_SIDED|97.5|-3.34|1.57||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||1.57|-3.34|0.41
91643493|NCT04636437|183178952|SUPERIORITY||Mean Difference (Net)|0.83||||0.31|TWO_SIDED|97.5|-0.99|2.64||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||2.64|-0.99|0.31
91643494|NCT04636437|183178952|SUPERIORITY||Mean Difference (Net)|-1.99||||0.012|TWO_SIDED|97.5|-3.76|-0.21||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||-0.21|-3.76|0.012
91643495|NCT04636437|183178953|SUPERIORITY||Mean Difference (Net)|1.72||||0.2|TWO_SIDED|97.5|-1.33|4.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||4.77|-1.33|0.20
91643496|NCT04636437|183178953|SUPERIORITY||Mean Difference (Net)|-1.49||||0.25|TWO_SIDED|97.5|-4.43|1.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||1.44|-4.43|0.25
91706192|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8374|TWO_SIDED|90.0|-0.61|0.48|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.48|-0.61|0.8374
91643497|NCT04636437|183178954|SUPERIORITY||Mean Difference (Net)|-0.16||||0.9|TWO_SIDED|97.5|-3.23|2.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||2.90|-3.23|0.90
91643498|NCT04636437|183178954|SUPERIORITY||Mean Difference (Net)|-1.48||||0.26|TWO_SIDED|97.5|-4.47|1.51||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||1.51|-4.47|0.26
91643499|NCT04636437|183178955|SUPERIORITY||Mean Difference (Net)|1.19||||0.91|TWO_SIDED|97.5|-22.2|24.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||24.59|-22.2|0.91
91643500|NCT04636437|183178955|SUPERIORITY||Mean Difference (Net)|-7.1||||0.48|TWO_SIDED|97.5|-29.7|15.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||15.47|-29.7|0.48
91643501|NCT04636437|183178956|SUPERIORITY||Mean Difference (Net)|-15.2||||0.3|TWO_SIDED|97.5|-48.6|18.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||18.20|-48.6|0.30
91643502|NCT04636437|183178956|SUPERIORITY||Mean Difference (Net)|-18.5||||0.21|TWO_SIDED|97.5|-51.8|14.76||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||14.76|-51.8|0.21
91643503|NCT04636437|183178957|SUPERIORITY||Mean Difference (Net)|-2.84||||0.58|TWO_SIDED|97.5|-14.4|8.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||8.72|-14.4|0.58
91643504|NCT04636437|183178957|SUPERIORITY||Mean Difference (Net)|-6.88||||0.16|TWO_SIDED|97.5|-18.0|4.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||4.20|-18.0|0.16
91643505|NCT04636437|183178958|SUPERIORITY||Mean Difference (Net)|-2.92||||0.47|TWO_SIDED|97.5|-12.1|6.27||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||6.27|-12.1|0.47
91643506|NCT04636437|183178958|SUPERIORITY||Mean Difference (Net)|-15.1|||<|0.001|TWO_SIDED|97.5|-24.2|-5.91||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||-5.91|-24.2|<0.001
91643507|NCT04636437|183178959|SUPERIORITY||Mean Difference (Net)|0.8||||0.79|TWO_SIDED|97.5|-6.17|7.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||7.77|-6.17|0.79
91643508|NCT04636437|183178959|SUPERIORITY||Mean Difference (Net)|-5.46||||0.063|TWO_SIDED|97.5|-12.1|1.16||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||1.16|-12.1|0.063
91643509|NCT04636437|183178960|SUPERIORITY||Mean Difference (Net)|-1.38||||0.27|TWO_SIDED|97.5|-4.21|1.45||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||1.45|-4.21|0.27
91643510|NCT04636437|183178960|SUPERIORITY||Mean Difference (Net)|-5.45|||<|0.001|TWO_SIDED|97.5|-8.25|-2.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||-2.66|-8.25|<0.001
91643511|NCT04636437|183178961|SUPERIORITY||Mean Difference (Net)|1.55||||0.77|TWO_SIDED|97.5|-10.3|13.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||13.44|-10.3|0.77
91643512|NCT04636437|183178961|SUPERIORITY||Mean Difference (Net)|-5.23||||0.3|TWO_SIDED|97.5|-16.7|6.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||6.20|-16.7|0.30
91643513|NCT04636437|183178962|SUPERIORITY||Mean Difference (Net)|0.18||||0.96|TWO_SIDED|97.5|-8.78|9.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||9.15|-8.78|0.96
91643514|NCT04636437|183178962|SUPERIORITY||Mean Difference (Net)|-6.32||||0.11|TWO_SIDED|97.5|-15.2|2.55||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||2.55|-15.2|0.11
91643515|NCT04636437|183178963|SUPERIORITY||Mean Difference (Net)|8.07||||0.16|TWO_SIDED|97.5|-4.93|21.06||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.06|-4.93|0.16
91643516|NCT04636437|183178963|SUPERIORITY||Mean Difference (Net)|8.89||||0.1|TWO_SIDED|97.5|-3.37|21.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.15|-3.37|0.10
91643517|NCT04636437|183178964|SUPERIORITY||Mean Difference (Net)|4.28||||0.37|TWO_SIDED|97.5|-6.42|14.99||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||14.99|-6.42|0.37
91643518|NCT04636437|183178964|SUPERIORITY||Mean Difference (Net)|0.37||||0.94|TWO_SIDED|97.5|-10.0|10.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||10.77|-10.0|0.94
91643519|NCT04636437|183178965|SUPERIORITY||Mean Difference (Net)|2.77||||0.2|TWO_SIDED|97.5|-2.08|7.63||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||7.63|-2.08|0.20
91643520|NCT04636437|183178965|SUPERIORITY||Mean Difference (Net)|2.21||||0.28|TWO_SIDED|97.5|-2.44|6.87||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||6.87|-2.44|0.28
91643521|NCT04636437|183178966|SUPERIORITY||Mean Difference (Net)|1.79||||0.24|TWO_SIDED|97.5|-1.68|5.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||5.25|-1.68|0.24
91643522|NCT04636437|183178966|SUPERIORITY||Mean Difference (Net)|-0.57||||0.7|TWO_SIDED|97.5|-3.91|2.78||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||2.78|-3.91|0.70
91643523|NCT04636437|183178968|SUPERIORITY|||||||0.43||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.43
91643524|NCT04636437|183178968|SUPERIORITY|||||||0.26||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.26
91643525|NCT04636437|183178969|SUPERIORITY|||||||0.008||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.008
91643526|NCT04636437|183178969|SUPERIORITY|||||||0.068||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.068
91643527|NCT04636437|183178970|SUPERIORITY|||||||0.2||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.20
91643528|NCT04636437|183178970|SUPERIORITY|||||||0.56||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.56
91518617|NCT00675766|182911576|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.||Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||< 0.01
91643529|NCT04636437|183178971|SUPERIORITY||Mean Difference (Net)|3.43||||0.13|TWO_SIDED|97.5|-1.62|8.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||8.47|-1.62|0.13
91643530|NCT04636437|183178971|SUPERIORITY||Mean Difference (Net)|-0.09||||0.97|TWO_SIDED|97.5|-4.89|4.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||4.72|-4.89|0.97
91643531|NCT04636437|183178972|SUPERIORITY||Mean Difference (Net)|0.31||||0.78|TWO_SIDED|97.5|-2.18|2.8||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||2.80|-2.18|0.78
91518618|NCT00675766|182911576|SUPERIORITY_OR_OTHER||||||<|0.07|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.||Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.07
91518619|NCT00675766|182911576|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.||Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.09
91518620|NCT00675766|182911576|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.||Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||.72
91518621|NCT00675766|182911576|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.||Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.65
91643532|NCT04636437|183178972|SUPERIORITY||Mean Difference (Net)|1.24||||0.23|TWO_SIDED|97.5|-1.11|3.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||3.59|-1.11|0.23
91643533|NCT04636437|183178973|SUPERIORITY||Mean Difference (Net)|3.71||||0.18|TWO_SIDED|97.5|-2.48|9.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||9.90|-2.48|0.18
91643534|NCT04636437|183178973|SUPERIORITY||Mean Difference (Net)|-1.35||||0.6|TWO_SIDED|97.5|-7.23|4.53||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||4.53|-7.23|0.60
91643535|NCT04636437|183178974|SUPERIORITY||Mean Difference (Net)|4.19||||0.094|TWO_SIDED|97.5|-1.45|9.83||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|9.83|-1.45|0.094
91643536|NCT04636437|183178974|SUPERIORITY||Mean Difference (Net)|1.76||||0.46|TWO_SIDED|97.5|-3.59|7.11||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|7.11|-3.59|0.46
91643537|NCT04636437|183178975|SUPERIORITY||Mean Difference (Net)|2.19||||0.26|TWO_SIDED|97.5|-2.19|6.56||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||6.56|-2.19|0.26
91643538|NCT04636437|183178975|SUPERIORITY||Mean Difference (Net)|3.15||||0.084|TWO_SIDED|97.5|-0.96|7.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||7.25|-0.96|0.084
91643539|NCT04636437|183178976|SUPERIORITY||Mean Difference (Net)|0.78||||0.19|TWO_SIDED|97.5|-0.57|2.13||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||2.13|-0.57|0.19
91643540|NCT04636437|183178976|SUPERIORITY||Mean Difference (Net)|-0.64||||0.27|TWO_SIDED|97.5|-1.93|0.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||0.66|-1.93|0.27
91518622|NCT00675766|182911576|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.||Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.79
91643541|NCT04636437|183178977|SUPERIORITY||Mean Difference (Net)|0.5||||0.58|TWO_SIDED|97.5|-1.57|2.58||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.58|-1.57|0.58
91643542|NCT04636437|183178977|SUPERIORITY||Mean Difference (Net)|0.05||||0.95|TWO_SIDED|97.5|-1.93|2.03||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.03|-1.93|0.95
91643543|NCT01821391|183178982|SUPERIORITY||||||=|0.2665|||||||Paired Student's t test|||||||=0.2665
91643544|NCT03417102|183178989|SUPERIORITY||ABR ratio|0.092|||<|0.0001|TWO_SIDED|95.0|0.044|0.192||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.192|0.044|<0.0001
91643545|NCT03417102|183178991|SUPERIORITY||ABR ratio|0.108|||<|0.0001|TWO_SIDED|95.0|0.056|0.207||P-value derived from NB regression model, accounted for different follow-up times during TP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.207|0.056|<0.0001
91643546|NCT03417102|183178993|SUPERIORITY||ABR ratio|0.056|||<|0.0001|TWO_SIDED|95.0|0.026|0.121||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.121|0.026|<0.0001
91643547|NCT03417102|183178995|SUPERIORITY||ABR ratio|0.098|||<|0.0001|TWO_SIDED|95.0|0.046|0.21||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.210|0.046|<0.0001
91643548|NCT03417102|183178997|SUPERIORITY||Least Square (LS) Mean difference|-28.72|||<|0.0001|TWO_SIDED|95.0|-39.07|-18.37||Analysis of Covariance (ANCOVA) model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-18.37|-39.07|<0.0001
91643549|NCT03417102|183178998|SUPERIORITY||LS Mean difference|-14.85|||<|0.0001|TWO_SIDED|95.0|-21.37|-8.33||ANCOVA model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-8.33|-21.37|<0.0001
91643550|NCT00795210|183179008|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|||Kruskal-Wallis Test for overall difference between groups||||0.01
91643551|NCT00795210|183179009|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||ANOVA|||||||0.42
91643552|NCT01017731|183179011|SUPERIORITY_OR_OTHER|||||||0.0161||||||The p-value for QTc interval prolongation compared to baseline.|Mixed Models Analysis|||||||0.0161
91643553|NCT02060526|183179056|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.286||||0.4615|TWO_SIDED|95.0|-0.297|0.745|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.745|-0.297|0.4615
91643554|NCT02060526|183179056|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.143||||1|TWO_SIDED|95.0|-0.423|0.647|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.647|-0.423|1.0000
91643555|NCT01441401|183179075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|||||||Fisher Exact|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no association between the baseline severity of epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||0.045
91643556|NCT01441401|183179075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Armitage (EXACT)|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the baseline severity of epileptic seizure (mild, moderate, and severe)."||||0.017
91643557|NCT01441401|183179076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Fisher Exact|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||0.018
91643558|NCT01441401|183179077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Fisher Exact|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||0.034
91643559|NCT01441401|183179077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Cochran-Armitage (EXACT)|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the increasing number of concomitant antiepileptic drugs at baseline."||||0.005
91643560|NCT01441401|183179078|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||"The factor tested was treatment period with gabapentin. The null hypothesis was that there was no association between the treatment period with gabapentin and the number of participants who responded to the treatment with gabapentin."||||<0.001
91706193|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.4305|TWO_SIDED|90.0|-0.28|0.8|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.28|0.4305
91643561|NCT00929201|183179125|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin \[i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.97||||||90.0|0.95|1.0||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||1.00|0.95|
91643562|NCT00929201|183179126|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin \[i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.95||||||90.0|0.93|0.98||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||0.98|0.93|
91643563|NCT00566969|183179127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hierarchical linear model was used to account for unequal variance and covariance structures across time.||||||0.1|||||||ANOVA|||||||.10
91643564|NCT01817764|183179131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|||<|0.001|TWO_SIDED|95.0|0.038|0.11|||ANCOVA|||||0.110|0.038|<0.001
91643565|NCT00388674|183179149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3553|TWO_SIDED|95.03|0.8|1.084|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.084|0.800|0.3553
91643566|NCT00388674|183179150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0676|TWO_SIDED|95.03|0.713|1.012|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.012|0.713|0.0676
91643567|NCT00388674|183179151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1182|TWO_SIDED|95.03|0.769|1.03|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.030|0.769|0.1182
91643568|NCT00388674|183179152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.817|1.478|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.478|0.817|
91643569|NCT00388674|183179153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.727|1.032|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.032|0.727|
91643570|NCT00388674|183179154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.608|1.365|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.365|0.608|
91643571|NCT01598740|183179185|SUPERIORITY_OR_OTHER|||||||0.0662||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.0662
91643572|NCT01598740|183179186|SUPERIORITY_OR_OTHER|||||||0.1899||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.1899
91643573|NCT00943826|183179222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.55|0.74||Stratified by Region and Recursive partitioning analysis (RPA) Class|Log Rank||Stratified by Region and RPA Class.|||0.74|0.55|<0.0001
91643574|NCT00943826|183179223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0987|TWO_SIDED|95.0|0.76|1.02|||Log Rank|Stratified by Region and RPA Class|Stratified by Region and RPA Class.|||1.02|0.76|0.0987
91643575|NCT00943826|183179224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.53|0.71||Stratified by Region and RPA Class.|Log Rank||Stratified by Region and RPA Class.|||0.71|0.53|<0.0001
91518623|NCT00675766|182911576|SUPERIORITY_OR_OTHER|||||||0.044|ONE_SIDED||||||Fisher Exact|One-sided Fisher's exact test with 1 degree of freedom.||Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.||||.044
91643576|NCT04764669|183179229|SUPERIORITY|Primary comparisons were: DLB without amyloid copathology versus DLB with amyloid copathology|Least squares mean difference|-20.022|||||TWO_SIDED|95.0|-77.635|37.591||||||||37.591|-77.635|
91643577|NCT04764669|183179229|SUPERIORITY|Primary comparisons were: PDD without amyloid copathology versus PDD with amyloid copathology.|Least squares mean difference|-175.65|||||TWO_SIDED|95.0|-287.407|-63.893||||||||-63.893|-287.407|
91643578|NCT00256217|183179237|OTHER||Mean Difference (Final Values)|4.9||||0.004|TWO_SIDED|95.0|1.8|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|1.8|0.004
91643579|NCT00256217|183179238|OTHER||Mean Difference (Final Values)|0.3||||0.016|TWO_SIDED|95.0|0.1|0.49|||Wilcoxon (Mann-Whitney)|||||0.49|0.10|0.016
91643580|NCT00877799|183179242|SUPERIORITY_OR_OTHER|||||||0.057|||||||t-test, 2 sided|||||||0.057
91643581|NCT00877799|183179243|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91643582|NCT00877799|183179244|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91643583|NCT01785472|183179252|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test was made at a one-sided significance level of 0.025.|least Square Means net difference|-2.33|STANDARD_ERROR_OF_MEAN|0.85|<|0.001||95.0|-4.0|-0.66|||ANCOVA|||||-0.66|-4.00|<0.001
91643584|NCT01803464|183179279|OTHER||Cohen's d|0.59|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled Standard Deviation (SD) of the % change for the 2 groups was the denominator.|||||
91643585|NCT01803464|183179279|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
91643586|NCT01803464|183179279|OTHER||Cohen's d|0.51|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
91643587|NCT01803464|183179280|OTHER||Cohen's d|0.45|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
91643588|NCT01803464|183179280|OTHER||Cohen's d|0.57|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
91643589|NCT01803464|183179280|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
91643590|NCT01803464|183179281|OTHER||Cohen's d|1.2|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
91643591|NCT01803464|183179281|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
91643592|NCT01803464|183179281|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
91643593|NCT02424851|183179282|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
91643594|NCT02424851|183179283|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
91643595|NCT02424851|183179284|OTHER||||||=|0.48|||||||Fisher Exact|||Statistical analysis of SAEs.||||=0.48
91643596|NCT02424851|183179284|OTHER||||||=|0.25|||||||Fisher Exact|||Statistical analysis of AEs||||=0.25
91643597|NCT02424851|183179285|OTHER||||||=|0.31|||||||Log Rank|||||||= 0.31
91643598|NCT02424851|183179286|OTHER||||||=|0.45|||||||Fisher Exact|||||||=0.45
91643599|NCT02424851|183179287|OTHER|||||||0.33|||||||t-test, 1 sided|||||||0.33
91643600|NCT00703261|183179296|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||cLDA|||Constrained longitudinal data analysis (cLDA)||||0.006
91643601|NCT00703261|183179296|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||cLDA|||||||0.277
91643602|NCT00703261|183179296|SUPERIORITY_OR_OTHER||Percent Reduction|4.5||||0.088|TWO_SIDED|90.0|-1.0|9.6|||cLDA|||||9.6|-1.0|0.088
91643603|NCT00703261|183179297|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||cLDA|||||||0.195
91643604|NCT01125358|183179298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.02|||||TWO_SIDED|90.0|-3.37|0.0|||Multiple Comparisons with The Best (MCB)|LS mean difference = LS mean of 10 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.00|-3.37|
91643605|NCT01125358|183179298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.05|||||TWO_SIDED|90.0|-2.42|0.32|||Multiple Comparison with The Best (MCB)|LS mean difference = LS mean of 160 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.32|-2.42|
91643606|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-9.84|STANDARD_ERROR_OF_MEAN|7.96||0.222|TWO_SIDED|95.0|-25.8|6.12||P-value is for PANSS Total Score.|MMRM|||||6.12|-25.80|0.222
91643607|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-11.91|STANDARD_ERROR_OF_MEAN|7.22||0.105|TWO_SIDED|95.0|-26.42|2.6||P-value is for PANSS Total Score.|MMRM|||||2.60|-26.42|0.105
91643608|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-7.96|STANDARD_ERROR_OF_MEAN|7.73||0.308|TWO_SIDED|95.0|-23.46|7.55||P-value is for PANSS Total Score.|MMRM|||||7.55|-23.46|0.308
91643609|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.6|STANDARD_ERROR_OF_MEAN|2.06||0.441|TWO_SIDED|95.0|-5.74|2.54||P-value is for PANSS Positive Subscore.|MMRM|||||2.54|-5.74|0.441
91643610|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-4.22|STANDARD_ERROR_OF_MEAN|1.88||0.03||95.0|-8.01|-0.44||P-value is for PANSS Positive Subscore.|MMRM|||||-0.44|-8.01|0.030
91643611|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.98|STANDARD_ERROR_OF_MEAN|1.98||0.323|TWO_SIDED|95.0|-5.96|2.01||P-value is for PANSS Positive Subscore.|MMRM|||||2.01|-5.96|0.323
91643612|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.46|STANDARD_ERROR_OF_MEAN|2.28||0.285|TWO_SIDED|95.0|-7.05|2.12||P-value is for PANSS Negative Subscore.|MMRM|||||2.12|-7.05|0.285
91643613|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.92|STANDARD_ERROR_OF_MEAN|2.07||0.166|TWO_SIDED|95.0|-7.1|1.26||P-value is for PANSS Negative Subscore.|MMRM|||||1.26|-7.10|0.166
91643614|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.37|STANDARD_ERROR_OF_MEAN|2.2||0.286|TWO_SIDED|95.0|-6.79|2.05||P-value is for PANSS Negative Subscore.|MMRM|||||2.05|-6.79|0.286
91643615|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.67|STANDARD_ERROR_OF_MEAN|4.14||0.177|TWO_SIDED|95.0|-13.96|2.63||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.63|-13.96|0.177
91643616|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.1|STANDARD_ERROR_OF_MEAN|3.74||0.178|TWO_SIDED|95.0|-12.6|2.4||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.40|-12.60|0.178
91643617|NCT01125358|183179299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.61|STANDARD_ERROR_OF_MEAN|4.05||0.377|TWO_SIDED|95.0|-11.72|4.51||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||4.51|-11.72|0.377
91643618|NCT01125358|183179300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.077|TWO_SIDED|95.0|-0.1|1.83|||MMRM|||||1.83|-0.10|0.077
91643619|NCT01125358|183179300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.44||0.592|TWO_SIDED|95.0|-1.12|0.65|||MMRM|||||0.65|-1.12|0.592
91643620|NCT01125358|183179300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.39|STANDARD_ERROR_OF_MEAN|0.46||0.395|TWO_SIDED|95.0|-0.53|1.32|||MMRM|||||1.32|-0.53|0.395
91643621|NCT01125358|183179301|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|4.64|STANDARD_ERROR_OF_MEAN|4.49||0.306|TWO_SIDED|95.0|-4.37|13.65|||MMRM|||||13.65|-4.37|0.306
91643622|NCT01125358|183179301|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.82|STANDARD_ERROR_OF_MEAN|4.26||0.849|TWO_SIDED|95.0|-7.74|9.38|||MMRM|||||9.38|-7.74|0.849
91643623|NCT01125358|183179301|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.09|STANDARD_ERROR_OF_MEAN|4.46||0.259||95.0|-14.05|3.86|||MMRM|||||3.86|-14.05|0.259
91643624|NCT01125358|183179303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0|||||Fisher Exact|||||||0.354
91643625|NCT01125358|183179303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181||95.0|||||Fisher Exact|||||||0.181
91643626|NCT01125358|183179303|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
91643627|NCT02115373|183179311|OTHER||Median|2.07|||||TWO_SIDED|90.0|1.446|7.195|||||TTP in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||7.195|1.446|
91643628|NCT02115373|183179311|OTHER||Median|3.98|||||TWO_SIDED|90.0|2.858|4.238|||||TTP in months was calculated for Phase 2: Tepotinib 500 mg.|||4.238|2.858|
91643629|NCT02115373|183179312|OTHER||Median|1.51|||||TWO_SIDED|90.0|1.413|3.68|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.680|1.413|
91643630|NCT02115373|183179312|OTHER||Median|3.22|||||TWO_SIDED|90.0|0.03|16.53|||||PFS time in months was calculated for Phase 2: Tepotinib 500 mg.|||16.53|0.03|
91643631|NCT02115373|183179313|OTHER||Median|1.48|||||TWO_SIDED|90.0|1.413|3.844|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.844|1.413|
91643632|NCT02115373|183179313|OTHER||Median|3.35|||||TWO_SIDED|90.0|2.76|4.172|||||PFS time in months was was calculated for Phase 2: Tepotinib 500 mg.|||4.172|2.760|
91643633|NCT02115373|183179315|OTHER||Median|7.2|||||TWO_SIDED|90.0|3.68|10.119|||||Overall Survival time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||10.119|3.680|
91643634|NCT02115373|183179315|OTHER||Median|5.55|||||TWO_SIDED|90.0|5.092|8.181|||||Overall Survival time in months was calculated for Phase 2: Tepotinib 500 mg.|||8.181|5.092|
91643635|NCT04007406|183179357|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold value for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.0001
91643636|NCT04007406|183179358|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
91643637|NCT04007406|183179359|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
91643638|NCT04007406|183179360|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
91643639|NCT04007406|183179361|SUPERIORITY||||||<|0.0001||||||The statistical threshold was p\<0.05|Mixed Models Analysis|||||||<0.0001
91643640|NCT03159611|183179362|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91643641|NCT03159611|183179363|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
91643642|NCT03159611|183179364|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
91643643|NCT03159611|183179365|SUPERIORITY|||||||0.2|||||||Cochran-Mantel-Haenszel|||||||0.20
91643644|NCT03159611|183179366|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91643645|NCT01984229|183179369|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|118.0|||||TWO_SIDED|90.0|102.0|137.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals (CIs).||137|102|
91643646|NCT01984229|183179370|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|177.0|||||TWO_SIDED|90.0|159.0|198.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||198|159|
91643647|NCT01984229|183179371|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|175.0|||||TWO_SIDED|90.0|157.0|195.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||195|157|
91643648|NCT01984229|183179375|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|28.7|||||TWO_SIDED|90.0|23.1|35.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||35.5|23.1|
91643649|NCT01984229|183179376|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|66.2|||||TWO_SIDED|90.0|56.7|77.4|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||77.4|56.7|
91643650|NCT01984229|183179377|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|75.1|||||TWO_SIDED|90.0|64.4|87.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||87.7|64.4|
91643651|NCT02072174|183179388|SUPERIORITY|||||||0.0242|||||||Kruskal-Wallis|||||||0.0242
91643652|NCT02072174|183179389|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||patient diary data||||0.0026
91643653|NCT02072174|183179389|SUPERIORITY|||||||0.0127|||||||Cochran-Mantel-Haenszel|||doctor's examination data||||0.0127
91643654|NCT02072174|183179390|SUPERIORITY|||||||0.0394||||||"The p-value associated with treatment factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate. Treatment\*visit interaction p-value is 0.3220."|Mixed Models Analysis|||||||0.0394
91643655|NCT02072174|183179390|SUPERIORITY|||||||0.322||||||"The p-value associated with treatment\*visit interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate."|Mixed Models Analysis|||||||0.3220
91643656|NCT02072174|183179391|SUPERIORITY|||||||0.0043|||||||Cochran-Mantel-Haenszel|||||||0.0043
91643657|NCT02072174|183179392|SUPERIORITY|||||||0.0104||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 2 (patient diary data)||||0.0104
91643658|NCT02072174|183179392|SUPERIORITY|||||||0.0041||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (patient diary data)||||0.0041
91643659|NCT02072174|183179392|SUPERIORITY|||||||0.0484||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 4 (patient diary data)||||0.0484
91643660|NCT02072174|183179392|SUPERIORITY|||||||0.0603||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (patient diary data)||||0.0603
91643661|NCT02072174|183179392|SUPERIORITY|||||||0.0056||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (doctor's examination)||||0.0056
91643662|NCT02072174|183179392|SUPERIORITY|||||||0.0994||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (doctor's examination)||||0.0994
91643663|NCT02072174|183179393|SUPERIORITY|||||||0.0084|||||||Kruskal-Wallis|||Days 1-7 (patient diary data)||||0.0084
91643664|NCT02072174|183179393|SUPERIORITY|||||||0.0233|||||||Kruskal-Wallis|||Days 1, 3, 5 and 7 (doctor's examination)||||0.0233
91643665|NCT02072174|183179394|SUPERIORITY|||||||0.0721|||||||Mixed Models Analysis|||||||0.0721
91643666|NCT02072174|183179395|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
91643667|NCT02072174|183179396|SUPERIORITY|||||||0.3383|||||||Fisher Exact|||||||0.3383
91643668|NCT02587117|183179397|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.004
91643669|NCT02587117|183179398|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.224
91643670|NCT01875731|183179422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.09||||0.01|TWO_SIDED|95.0|1.57|16.8|||Chi-squared|||||16.8|1.57|0.01
91643671|NCT01875731|183179423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.71|TWO_SIDED|95.0|0.1|4.09|||Chi-squared|||||4.09|0.1|0.71
91643672|NCT06212544|183179424|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91654914|NCT00936975|183202609|SUPERIORITY_OR_OTHER||Slope|-0.0177|STANDARD_ERROR_OF_MEAN|0.0125||0.16|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.16
91654915|NCT00936975|183202610|SUPERIORITY_OR_OTHER||Slope|0.0017|STANDARD_ERROR_OF_MEAN|0.0027||0.53|TWO_SIDED||||||Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.53
91654916|NCT00936975|183202610|SUPERIORITY_OR_OTHER||Slope|0.0205|STANDARD_ERROR_OF_MEAN|0.0128||0.1095|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: influx(Ki) is the same in normal and tumor bones||||0.1095
91654917|NCT00936975|183202611|SUPERIORITY_OR_OTHER||Slope|0.0061|STANDARD_ERROR_OF_MEAN|0.0021||0.0033|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.0033
91654918|NCT00936975|183202611|SUPERIORITY_OR_OTHER||Slope|0.0177|STANDARD_ERROR_OF_MEAN|0.0097||0.067|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones||||0.0670
91654919|NCT00936975|183202611|SUPERIORITY_OR_OTHER||Slope|32.3288|STANDARD_ERROR_OF_MEAN|14.6956||0.0278|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations||Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones||||0.0278
91654920|NCT01656889|183202629|SUPERIORITY_OR_OTHER|||||||0.5896|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the chi-squared proportion of wounds closed in each group.||||||0.5896
91654921|NCT01656889|183202630|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|0.0|||||Regression, Cox|||||||.3675
91654922|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.6426|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 01||||0.6426
91654923|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.3843|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 02||||.3843
91654924|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 03||||0.2792
91706194|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.325||0.9733|TWO_SIDED|90.0|-0.55|0.53|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.53|-0.55|0.9733
91654925|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.1502|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 04||||0.1502
91654926|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.3823|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 05||||0.3823
91654927|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 06||||0.5528
91654928|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.02913|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 07||||.02913
91643673|NCT00684645|183179450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.257|0.609|||Cox proportional hazard|||Time to PFS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.609|0.257|<0.0001
91643674|NCT00684645|183179451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.361||||0.0221|TWO_SIDED|95.0|0.151|0.864|||Cox proportional hazard|||Time to OS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.864|0.151|0.0221
91643675|NCT02513095|183179458|SUPERIORITY||Odds Ratio (OR)|6.0||||0.396|TWO_SIDED|95.0|0.6|76.8|||Chi-squared, Corrected|||||76.8|0.6|0.396
91643676|NCT00391092|183179487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0775|TWO_SIDED|95.0|0.65|1.02|||Log Rank (unstratified)|||||1.02|0.65|0.0775
91643677|NCT00391092|183179488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9543|TWO_SIDED|95.0|0.74|1.38|||Log Rank|||||1.38|0.74|0.9543
91643678|NCT00391092|183179489|SUPERIORITY_OR_OTHER||Difference in Response rates|4.43||||0.3492|TWO_SIDED|95.0|-5.2|14.0|||Chi-squared||95% CI for the difference in response rates using Hauck-Anderson method.|||14.0|-5.2|0.3492
91643679|NCT00391092|183179490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.98||||||||0.98|0.56|
91643680|NCT00391092|183179491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5392|TWO_SIDED|95.0|0.76|1.15|||Log Rank|||||1.15|0.76|0.5392
91643681|NCT00467038|183179494|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED||||||t-test, 1 sided|\<0.004 p value was common for all time points.||||||<0.004
91518624|NCT01018394|182911605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.108|TWO_SIDED|95.0|0.7|5.1||A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|Fisher Exact|1 tailed||The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.||5.1|0.7|0.108
91643682|NCT00467038|183179495|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher's LSD post-hoc, trend level|||||||0.08
91643683|NCT02545868|183179505|SUPERIORITY||normal distribution approximation|-30.7|||||TWO_SIDED|95.0|-50.5|-10.8||||||Difference in positive response, Group A minus Group B||-10.8|-50.5|
91643684|NCT02545868|183179506|SUPERIORITY||normal distribution approximation|-36.4|||||TWO_SIDED|95.0|-56.0|-16.7||||||Difference in positive response, Group A minus Group B||-16.7|-56.0|
91643685|NCT02545868|183179507|SUPERIORITY||normal distribution approximation|-47.0|||||TWO_SIDED|95.0|-63.2|-30.7||||||Difference in positive response, Group A minus Group B||-30.7|-63.2|
91643686|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-50.7|||||TWO_SIDED|95.0|-62.7|-38.8||||||Serotype 1||-38.8|-62.7|
91643687|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-43.3|||||TWO_SIDED|95.0|-56.5|-30.1||||||Serotype 2||-30.1|-56.5|
91643688|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-48.0|||||TWO_SIDED|95.0|-65.2|-30.9||||||Serotype 3||-30.9|-65.2|
91643689|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 4||-48.4|-77.2|
91643690|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-53.8|||||TWO_SIDED|95.0|-68.0|-39.7||||||Serotype 5||-39.7|-68.0|
91643691|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-37.5|||||TWO_SIDED|95.0|-54.4|-20.7||||||Serotype 6B||-20.7|-54.4|
91643692|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-73.1|-43.6||||||Serotype 7F||-43.6|-73.1|
91643693|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-32.9|||||TWO_SIDED|95.0|-45.7|-20.1||||||Serotype 8||-20.1|-45.7|
91643694|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 9N||-30.4|-62.5|
91643695|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-40.4|||||TWO_SIDED|95.0|-55.7|-25.1||||||Serotype 9V||-25.1|-55.7|
91643696|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 10A||-48.4|-77.2|
91643697|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-69.4|-35.6||||||Serotype 11A||-35.6|-69.4|
91643698|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-72.8|-38.3||||||Serotype 12F||-38.3|-72.8|
91643699|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.4|-9.7||||||Serotype 14||-9.7|-41.4|
91643700|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-47.9|||||TWO_SIDED|95.0|-63.9|-32.0||||||Serotype 15B||-32.0|-63.9|
91643701|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-56.9|||||TWO_SIDED|95.0|-72.4|-41.4||||||Serotype 17F||-41.4|-72.4|
91643702|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-52.4|||||TWO_SIDED|95.0|-67.4|-37.3||||||Serotype 18C||-37.3|-67.4|
91643703|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 19A||-30.4|-62.5|
91643704|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-68.8|-36.1||||||Serotype 19F||-36.1|-68.8|
91643705|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-61.5|||||TWO_SIDED|95.0|-77.5|-45.4||||||Serotype 20||-45.4|-77.5|
91643706|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-71.7|-42.0||||||Serotype 22F||-42.0|-71.7|
91643707|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-33.2|||||TWO_SIDED|95.0|-51.7|-14.6||||||Serotype 23F||-14.6|-51.7|
91643708|NCT02545868|183179511|SUPERIORITY||Normal Distribution Approximation|-47.8|||||TWO_SIDED|95.0|-62.2|-33.5||||||Serotype 33F||-33.5|-62.2|
91643709|NCT02545868|183179512|SUPERIORITY||Normal Distribution Approximation|-13.4|||||TWO_SIDED|95.0|-21.6|-5.3||||||||-5.3|-21.6|
91643710|NCT02545868|183179513|SUPERIORITY||Normal Distribution Approximation|-59.7|||||TWO_SIDED|95.0|-72.6|-46.8||||||||-46.8|-72.6|
91643711|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-45.2|||||TWO_SIDED|95.0|-62.7|-27.6||||||Serotype 1- Difference in positive response, Group A1 minus Group B||-27.6|-62.7|
91643712|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 2- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
91643713|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-49.8|||||TWO_SIDED|95.0|-70.4|-29.2||||||Serotype 3- Difference in positive response, Group A1 minus Group B||-29.2|-70.4|
91643714|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-56.0|||||TWO_SIDED|95.0|-75.7|-36.3||||||Serotype 4- Difference in positive response, Group A1 minus Group B||-36.3|-75.7|
91643715|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-76.4|-40.3||||||Serotype 5- Difference in positive response, Group A1 minus Group B||-40.3|-76.4|
91643716|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-34.0|||||TWO_SIDED|95.0|-55.7|-12.2||||||Serotype 6B- Difference in positive response, Group A1 minus Group B||-12.2|-55.7|
91643717|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 7F- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
91643718|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 8- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
91643719|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-37.2|||||TWO_SIDED|95.0|-58.9|-15.5||||||Serotype 9N- Difference in positive response, Group A1 minus Group B||-15.5|-58.9|
91643720|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-36.6|||||TWO_SIDED|95.0|-57.3|-16.0||||||Serotype 9V- Difference in positive response, Group A1 minus Group B||-16.0|-57.3|
91643721|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-62.1|||||TWO_SIDED|95.0|-80.8|-43.5||||||Serotype 10A- Difference in positive response, Group A1 minus Group B||-43.5|-80.8|
91643722|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-50.1|||||TWO_SIDED|95.0|-71.0|-29.2||||||Serotype 11A- Difference in positive response, Group A1 minus Group B||-29.2|-71.0|
91643723|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-76.9|-36.8||||||Serotype 12F- Difference in positive response, Group A1 minus Group B||-36.8|-76.9|
91643724|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-20.8|||||TWO_SIDED|95.0|-41.4|-0.2||||||Serotype 14- Difference in positive response, Group A1 minus Group B||-0.2|-41.4|
91643725|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-52.8|||||TWO_SIDED|95.0|-72.8|-32.7||||||Serotype 15B- Difference in positive response, Group A1 minus Group B||-32.7|-72.8|
91643726|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 17F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
91643727|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 18C- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
91643728|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-30.2|||||TWO_SIDED|95.0|-50.6|-9.7||||||Serotype 19A- Difference in positive response, Group A1 minus Group B||-9.7|-50.6|
91643729|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 19F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
91643730|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-79.0|-40.0||||||Serotype 20- Difference in positive response, Group A1 minus Group B||-40.0|-79.0|
91643731|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-72.1|-32.8||||||Serotype 22F- Difference in positive response, Group A1 minus Group B||-32.8|-72.1|
91643732|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-28.1|||||TWO_SIDED|95.0|-50.7|-5.4||||||Serotype 23F- Difference in positive response, Group A1 minus Group B||-5.4|-50.7|
91643733|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-49.0|||||TWO_SIDED|95.0|-68.2|-29.7||||||Serotype 33F- Difference in positive response, Group A1 minus Group B||-29.7|-68.2|
91643734|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-78.1|-45.4||||||Serotype 1- Difference in positive response, Group A2 minus Group B||-45.4|-78.1|
91643735|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 2- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
91643736|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-55.9|||||TWO_SIDED|95.0|-75.3|-36.5||||||Serotype 3- Difference in positive response, Group A2 minus Group B||-36.5|-75.3|
91643737|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-64.7|||||TWO_SIDED|95.0|-82.6|-46.8||||||Serotype 4- Difference in positive response, Group A2 minus Group B||-46.8|-82.6|
91643738|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 5- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
91643739|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 6B- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
91643740|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-76.7|-40.9||||||Serotype 7F- Difference in positive response, Group A2 minus Group B||-40.9|-76.7|
91643741|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-29.4|||||TWO_SIDED|95.0|-46.1|-12.7||||||Serotype 8- Difference in positive response, Group A2 minus Group B||-12.7|-46.1|
91643742|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-35.3|||||TWO_SIDED|95.0|-56.4|-14.2||||||Serotype 9N- Difference in positive response, Group A2 minus Group B||-14.2|-56.4|
91643743|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-58.2|-18.2||||||Serotype 9V- Difference in positive response, Group A2 minus Group B||-18.2|-58.2|
91643744|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.8|-43.7||||||Serotype 10A- Difference in positive response, Group A2 minus Group B||-43.7|-79.8|
91643745|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 11A- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
91643746|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-78.0|-39.6||||||Serotype 12F- Difference in positive response, Group A2 minus Group B||-39.6|-78.0|
91643747|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-17.6|||||TWO_SIDED|95.0|-37.4|2.1||||||Serotype 14- Difference in positive response, Group A2 minus Group B||2.1|-37.4|
91643748|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-69.6|-30.4||||||Serotype 15B- Difference in positive response, Group A2 minus Group B||-30.4|-69.6|
91643749|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-44.1|||||TWO_SIDED|95.0|-64.0|-24.2||||||Serotype 17F- Difference in positive response, Group A2 minus Group B||-24.2|-64.0|
91643750|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.4|-44.2||||||Serotype 18C- Difference in positive response, Group A2 minus Group B||-44.2|-79.4|
91643751|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-72.3|-33.6||||||Serotype 19A- Difference in positive response, Group A2 minus Group B||-33.6|-72.3|
91643752|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-77.6|-40.1||||||Serotype 19F- Difference in positive response, Group A2 minus Group B||-40.1|-77.6|
91643753|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-70.6|||||TWO_SIDED|95.0|-87.4|-53.8||||||Serotype 20- Difference in positive response, Group A2 minus Group B||-53.8|-87.4|
91643754|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-67.6|||||TWO_SIDED|95.0|-84.8|-50.5||||||Serotype 22F- Difference in positive response, Group A2 minus Group B||-50.5|-84.8|
91643755|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-47.1|||||TWO_SIDED|95.0|-68.0|-26.1||||||Serotype 23F- Difference in positive response, Group A2 minus Group B||-26.1|-68.0|
91643756|NCT02545868|183179515|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-68.5|-31.5||||||Serotype 33F- Difference in positive response, Group A2 minus Group B||-31.5|-68.5|
91643757|NCT02545868|183179517|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.6|-9.5||||||Strain = H1N1CA09 (Group A2 minus Group B)||-9.5|-41.6|
91643758|NCT02545868|183179517|SUPERIORITY||Normal Distribution Approximation|-14.0|||||TWO_SIDED|95.0|-35.2|7.3||||||Strain = BPHU13 (Group A2 minus Group B)||7.3|-35.2|
91643759|NCT02545868|183179517|SUPERIORITY||Normal Distribution Approximation|-25.9|||||TWO_SIDED|95.0|-45.5|-6.4||||||Strain = H3N2SW13 (Group A2 minus Group B)||-6.4|-45.5|
91643760|NCT02545868|183179517|SUPERIORITY||Normal Distribution Approximation|-19.4|||||TWO_SIDED|95.0|-50.7|11.8||||||Strain = BBRIS08 (Group A2 minus Group B)||11.8|-50.7|
91643761|NCT02545868|183179517|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
91643762|NCT02545868|183179518|SUPERIORITY||Normal Distribution Approximation|-41.8|||||TWO_SIDED|95.0|-61.9|-21.7||||||Strain = H1N1CA09 (Group A2 minus Group B)||-21.7|-61.9|
91643763|NCT02545868|183179518|SUPERIORITY||Normal Distribution Approximation|-37.6|||||TWO_SIDED|95.0|-59.7|-15.5||||||Strain = BPHU13 (Group A2 minus Group B)||-15.5|-59.7|
91643764|NCT02545868|183179518|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-78.2|-40.7||||||Strain = H3N2SW13 (Group A2 minus Group B)||-40.7|-78.2|
91643765|NCT02545868|183179518|SUPERIORITY||Normal Distribution Approximation|-45.6|||||TWO_SIDED|95.0|-76.0|-15.1||||||Strain = BBRIS08 (Group A2 minus Group B)||-15.1|-76.0|
91643766|NCT02545868|183179518|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
91643767|NCT02545868|183179519|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B||-42.3|-80.2|
91643768|NCT02545868|183179519|SUPERIORITY||Normal Distribution Approximation|-54.8|||||TWO_SIDED|95.0|-75.3|-34.4||||||Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B||-34.4|-75.3|
91643769|NCT02545868|183179519|SUPERIORITY||Normal Distribution Approximation|-82.3|||||TWO_SIDED|95.0|-97.1|-67.5||||||Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B||-67.5|-97.1|
91643770|NCT02545868|183179519|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B||-6.1|-67.2|
91643771|NCT02545868|183179519|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B||50.5|-63.8|
91643772|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 (Group A2 minus Group B) \[FDA\]||-42.3|-80.2|
91643773|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-46.0|||||TWO_SIDED|95.0|-88.0|-4.0||||||Strain = H1N1CA09 (Group A2 minus Group B) \[Protocol\]||-4.0|-88.0|
91643774|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-57.9|||||TWO_SIDED|95.0|-77.7|-38.1||||||Strain = BPHU13 (Group A2 minus Group B) \[FDA\]||-38.1|-77.7|
91643775|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-88.0|-23.1||||||Strain = BPHU13 (Group A2 minus Group B) \[Protocol\]||-23.1|-88.0|
91643776|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-78.5|||||TWO_SIDED|95.0|-94.8|-62.2||||||Strain = H3N2SW13 (Group A2 minus Group B) \[FDA\]||-62.2|-94.8|
91643777|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-57.8|||||TWO_SIDED|95.0|-100.0|-13.4||||||Strain = H3N2SW13 (Group A2 minus Group B) \[Protocol\]||-13.4|-100.0|
91643778|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 (Group A2 minus Group B) \[FDA\]||-6.1|-67.2|
91643779|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-25.0|||||TWO_SIDED|95.0|-67.4|17.4||||||Strain = BBRIS08 (Group A2 minus Group B) \[Protocol\]||17.4|-67.4|
91643780|NCT02545868|183179520|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 (Group A2 minus Group B) \[FDA\]||50.5|-63.8|
91643781|NCT01777191|183179546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.248|TWO_SIDED||||||Fisher Exact|||||||0.248
91643782|NCT01932801|183179549|SUPERIORITY|||||||0.461||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model stats: χ2(18, N=308) = 17.93, CFI = 1.00, RMSEA \< .001, SRMR = .07||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.461
91643783|NCT01932801|183179549|SUPERIORITY||Slope|-0.48||||0.01|TWO_SIDED|95.0|-0.79|-0.18||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period|z score for parameters||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.18|-.79|.01
91654929|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.3896|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 08||||0.3896
91524191|NCT01216163|182923479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|||<|0.001|TWO_SIDED|95.0|0.63|0.91||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.91|0.63|<0.001
91643784|NCT01932801|183179549|SUPERIORITY||Slope|-0.41||||0.01|TWO_SIDED|95.0|-0.67|-0.15|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.15|-.67|.01
91643785|NCT01932801|183179549|SUPERIORITY||Slope|-0.23||||0.19|TWO_SIDED|95.0|-0.52|0.06|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.06|-.52|.19
91643786|NCT01932801|183179550|SUPERIORITY|||||||0.347||||||Denotes exact fit for the omnibus model|Chi-squared|complete omnibus model statistics: χ2(20, N=308) = 21.89, CFI = 1.00, RMSEA = .02, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.347
91643787|NCT01932801|183179550|SUPERIORITY||Slope|-2.22||||0.002|TWO_SIDED|95.0|-3.39|-1.06||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-1.06|-3.39|.002
91643788|NCT01932801|183179550|SUPERIORITY||Slope|-0.82||||0.208|TWO_SIDED|95.0|-1.89|0.25||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.25|-1.89|.208
91643789|NCT01932801|183179550|SUPERIORITY||Slope|-1.58||||0.025|TWO_SIDED|95.0|-2.73|-0.42||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.42|-2.73|.025
91643790|NCT01932801|183179551|SUPERIORITY|||||||0.028||||||"p value reflects omnibus model close fit"|Chi-squared|χ2(13, N=308) = 24.34, CFI = .98, RMSEA = .05, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.028
91643791|NCT01932801|183179551|SUPERIORITY||Slope|-4.42||||0.047|TWO_SIDED|95.0|-8.09|-0.76||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.76|-8.09|.047
91643792|NCT01932801|183179551|SUPERIORITY||Slope|-5.95||||0.009|TWO_SIDED|95.0|-9.72|-2.19||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-2.19|-9.72|.009
91643793|NCT01932801|183179551|SUPERIORITY||Slope|-4.12||||0.072|TWO_SIDED|95.0|-7.88|-0.36||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.36|-7.88|.072
91654930|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.3989|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 09||||0.3989
91654931|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.8682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 10||||0.8682
91643794|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.6|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.6
91643795|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.83|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.83
91643796|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.89|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.89
91643797|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
91643798|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.87|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the placebo vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.87
91643799|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.02||0.91|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.91
91643800|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.38||0.54|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.54
91643801|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.32||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the placebo vs control effects on alcohol-related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
91643802|NCT01932801|183179552|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.29||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
91643803|NCT01932801|183179553|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.9||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on alcohol frequency and alcohol craving (PACS).|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
91654932|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.8083|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 11||||0.8083
91643804|NCT01932801|183179553|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.46|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails 2 treatment arms: XR-NTX vs placebo effects on craving and alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.46
91643805|NCT01932801|183179553|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.57|STANDARD_ERROR_OF_MEAN|0.75||0.45|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on craving and alcohol-related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.45
91643806|NCT01932801|183179554|SUPERIORITY|||||||0.95||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model : χ2(12, N=308) = .75, CFI = 1.00, RMSEA \< .001, SRMR = .008||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.95
91643807|NCT01932801|183179554|SUPERIORITY||Slope|-0.04||||0.75|TWO_SIDED|95.0|-0.24|0.16||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|Chi-squared|||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.16|-.24|.75
91643808|NCT01932801|183179554|SUPERIORITY||Slope|-0.15||||0.2|TWO_SIDED|95.0|-0.34|0.04|||Chi-squared|Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.04|-.34|.20
91643809|NCT01932801|183179554|SUPERIORITY||Slope|0.1||||0.39|TWO_SIDED|95.0|-0.09|0.29|||Chi-squared|Linear effects of HaRT-A compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.29|-.09|.39
91643810|NCT01932801|183179555|SUPERIORITY||incident rate ratio|0.98|||>|0.84|TWO_SIDED|95.0|0.83|1.16|||z|||We conducted a generalized estimating equations analysis (negative binomial distribution, log link) to test whether number of adverse events reported increased from baseline to the follow-ups differentially across placebo and XR-NTX groups||1.16|.83|>.84
91643811|NCT00568776|183179566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.71|TWO_SIDED|95.0|-0.14|0.21|||Mixed Models Analysis|||||0.21|-0.14|0.71
91643812|NCT00568776|183179567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-6.33|1.22|||Mixed Models Analysis|||||1.22|-6.33|0.18
91643813|NCT00568776|183179568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.06|0.36|||Mixed Models Analysis|||||0.36|-0.06|0.17
91643814|NCT00568776|183179569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.03||0.49|TWO_SIDED|95.0|-5.41|2.62|||Mixed Models Analysis|||||2.62|-5.41|0.49
91643815|NCT00568776|183179570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|2.2||0.77|TWO_SIDED|95.0|-3.73|5.03|||Mixed Models Analysis|||||5.03|-3.73|0.77
91643816|NCT00568776|183179571|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.47||0.54|TWO_SIDED|95.0|-0.63|1.21|||Mixed Models Analysis|||||1.21|-0.63|0.54
91643817|NCT00568776|183179572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|2.24||0.65|TWO_SIDED|95.0|-3.43|5.46|||Mixed Models Analysis|||||5.46|-3.43|0.65
91643818|NCT01563029|183179573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|9.6|22.4|||ANCOVA|Gate-keeper analysis||||22.4|9.6|<0.001
91643819|NCT01563029|183179573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||<|0.001|TWO_SIDED|95.0|5.1|19.8|||ANCOVA||Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.|||19.8|5.1|<0.001
91643820|NCT01563029|183179573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.5|||<|0.001|TWO_SIDED|95.0|12.1|26.9|||ANCOVA||Inference for FF 100 µg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.|||26.9|12.1|<0.001
91643821|NCT01563029|183179573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|11.3|26.0|||ANCOVA||Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebocomparison.|||26.0|11.3|<0.001
91643822|NCT01563029|183179573|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.0|||<|0.001|TWO_SIDED|95.0|6.7|21.4|||ANCOVA|||||21.4|6.7|<0.001
91643823|NCT01563029|183179574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.051|0.201|||ANCOVA|||||0.201|0.051|<0.001
91643824|NCT01563029|183179574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.551|TWO_SIDED|95.0|-0.05|0.094|||ANCOVA|||||0.094|-0.050|0.551
91643825|NCT01563029|183179574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.379|TWO_SIDED|95.0|-0.041|0.108|||ANCOVA|||||0.108|-0.041|0.379
91643826|NCT01563029|183179574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.089|TWO_SIDED|95.0|-0.01|0.137|||ANCOVA|||||0.137|-0.010|0.089
91643827|NCT01563029|183179575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4||||0.05|TWO_SIDED|95.0|0.0|16.9|||ANCOVA|||||16.9|0.0|0.050
91643828|NCT01563029|183179575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8||||0.023|TWO_SIDED|95.0|1.3|18.2|||ANCOVA|||||18.2|1.3|0.023
91643829|NCT01563029|183179575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.004|TWO_SIDED|95.0|3.8|20.5|||ANCOVA|||||20.5|3.8|0.004
91643830|NCT01563029|183179575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.143|TWO_SIDED|95.0|-2.1|14.6|||ANCOVA|||||14.6|-2.1|0.143
91643831|NCT01563029|183179576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.005|TWO_SIDED|95.0|3.4|19.0|||ANCOVA|||||19.0|3.4|0.005
91643832|NCT01563029|183179576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|||<|0.001|TWO_SIDED|95.0|5.7|21.1|||ANCOVA|||||21.1|5.7|<0.001
91643833|NCT01563029|183179576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||<|0.033|TWO_SIDED|95.0|0.7|16.1|||ANCOVA|||||16.1|0.7|<0.033
91643834|NCT01563029|183179576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0||||0.042|TWO_SIDED|95.0|0.3|15.7|||ANCOVA|||||15.7|0.3|0.042
91643835|NCT01563029|183179577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.037|TWO_SIDED|95.0|0.7|21.7|||ANCOVA|||||21.7|0.7|0.037
91643836|NCT01563029|183179577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1||||0.014|TWO_SIDED|95.0|2.6|23.6|||ANCOVA|||||23.6|2.6|0.014
91643837|NCT01563029|183179577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.266|TWO_SIDED|95.0|-4.5|16.3|||ANCOVA|||||16.3|-4.5|0.266
91643838|NCT01563029|183179577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.242|TWO_SIDED|95.0|-4.2|16.6|||ANCOVA|||||16.6|-4.2|0.242
91643839|NCT01563029|183179578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|10.0|31.3|||ANCOVA|||||31.3|10.0|<0.001
91643840|NCT01563029|183179578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.9||||0.001|TWO_SIDED|95.0|7.2|28.6|||ANCOVA|||||28.6|7.2|0.001
91643841|NCT01563029|183179578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5||||0.033|TWO_SIDED|95.0|0.9|22.1|||ANCOVA|||||22.1|0.9|0.033
91643842|NCT01563029|183179578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.002|TWO_SIDED|95.0|6.0|27.3|||ANCOVA|||||27.3|6.0|0.002
91643843|NCT01563029|183179579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.619|TWO_SIDED|95.0|-6.1|10.2|||ANCOVA|||||10.2|-6.1|0.619
91643844|NCT01563029|183179579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.161||95.0|-2.3|13.9|||ANCOVA|||||13.9|-2.3|0.161
91643845|NCT01563029|183179579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.34|TWO_SIDED|95.0|-4.1|12.0|||ANCOVA|||||12.0|-4.1|0.340
91643846|NCT01563029|183179579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.459|TWO_SIDED|95.0|-5.0|11.1|||ANCOVA|||||11.1|-5.0|0.459
91643847|NCT01563029|183179580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91643848|NCT01563029|183179580|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Fisher Exact|||||||0.006
91643849|NCT01563029|183179580|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
91643850|NCT01563029|183179580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91643851|NCT02780115|183179584|SUPERIORITY||LS Mean Diff|1.96||||0.1663|TWO_SIDED|95.0|-0.83|4.74|||ANCOVA|||||4.74|-0.83|0.1663
91643852|NCT02780115|183179584|SUPERIORITY||LS Mean Diff|4.77||||0.0009|TWO_SIDED|95.0|1.98|7.56|||ANCOVA|||||7.56|1.98|0.0009
91643853|NCT02780115|183179584|SUPERIORITY||LS Mean Diff|4.54||||0.0014|TWO_SIDED|95.0|1.79|7.29|||ANCOVA|||||7.29|1.79|0.0014
91643854|NCT02780115|183179584|SUPERIORITY||LS Mean Diff|4.81||||0.0008|TWO_SIDED|95.0|2.03|7.58|||ANCOVA|||||7.58|2.03|0.0008
91643855|NCT00769132|183179586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two treatments are comparable if the geometric mean ratio is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|1.12||||||90.0|0.9|1.38||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.38|0.9|
91643856|NCT00769132|183179586|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.07||||||||1.07|0.71|
91643857|NCT00769132|183179586|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.8||||||90.0|0.65|0.98||||||||0.98|0.65|
91643858|NCT00769132|183179586|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.89||||||90.0|0.72|1.09||||||||1.09|0.72|
91643859|NCT00769132|183179586|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.91||||||90.0|0.74|1.12||||||||1.12|0.74|
91643860|NCT00769132|183179586|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.02||||||90.0|0.83|1.25||||||||1.25|0.83|
91643861|NCT00769132|183179587|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.04||||||90.0|0.92|1.17||||||||1.17|0.92|
91643862|NCT00769132|183179587|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.9||||||90.0|0.8|1.01||||||||1.01|0.8|
91643863|NCT00769132|183179587|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.56||||||90.0|0.49|0.63||||||||0.63|0.49|
91643864|NCT00769132|183179587|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.58||||||90.0|0.51|0.65||||||||0.65|0.51|
91643865|NCT00769132|183179587|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.62||||||90.0|0.55|0.7||||||||0.7|0.55|
91643866|NCT00769132|183179587|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.64||||||90.0|0.57|0.72||||||||0.72|0.57|
91643867|NCT02723786|183179615|OTHER||||||||||||||||||The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF \<30% was 0.07 (HPD 95% CI \[0.00,1.00\]). The posterior probability for the proportion of participants with DGF \<50% was 0.34 (HPD 95% CI \[0.00,1.00\]).|||
91654933|NCT01656889|183202631|SUPERIORITY_OR_OTHER|||||||0.6687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 12||||0.6687
91654934|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.3601|TWO_SIDED||||||ANCOVA|||Week 01||||0.3601
91654935|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.9398|TWO_SIDED||||||ANCOVA|||Week 02||||0.9398
91654936|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANCOVA|||Week 03||||0.905
91643868|NCT00127192|183179636|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.6|||<|0.001||95.0|-4.3|-3.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-3.0|-4.3|<0.001
91643869|NCT00127192|183179636|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.2|||<|0.001||95.0|-3.9|-2.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.6|-3.9|<0.001
91643870|NCT00127192|183179636|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.3|||<|0.001||95.0|-3.9|-2.7||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.7|-3.9|<0.001
91643871|NCT00127192|183179636|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-2.6|||<|0.001||95.0|-3.2|-2.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.0|-3.2|<0.001
91643872|NCT00127192|183179637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Tukeys linear trend test based on ANCOVA|Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline||||||<0.001
91643873|NCT00127192|183179637|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-1.04|||<|0.001||95.0|-1.21|-0.86||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.86|-1.21|<0.001
91643874|NCT00127192|183179637|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.96|||<|0.001||95.0|-1.14|-0.79||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.79|-1.14|<0.001
91643875|NCT00127192|183179637|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.99|||<|0.001||95.0|-1.16|-0.82||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.82|-1.16|<0.001
91643876|NCT00127192|183179637|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.69|||<|0.001||95.0|-0.85|-0.52||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.52|-0.85|<0.001
91643877|NCT00127192|183179638|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-23.2|||<|0.001||95.0|-29.8|-16.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-16.6|-29.8|<0.001
91654937|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.4471|TWO_SIDED||||||ANCOVA|||Week 04||||0.4471
91654938|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.3004|TWO_SIDED||||||ANCOVA|||Week 05||||0.3004
91654939|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||ANCOVA|||Week 06||||0.1815
91654940|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANCOVA|||Week 07||||0.399
91643878|NCT00127192|183179638|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-20.8|||<|0.001||95.0|-27.4|-14.3||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-14.3|-27.4|<0.001
91654941|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.8027|TWO_SIDED||||||ANCOVA|||Week 08||||0.8027
91654942|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.4913|TWO_SIDED||||||ANCOVA|||Week 09||||0.4913
91654943|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.5227|TWO_SIDED||||||ANCOVA|||Week 10||||0.5227
91518625|NCT04184791|182911620|OTHER|A linear mixed-effects analysis of variance (LM-ANOVA) model was used to determine the effect of L-Dopa, frequency, the interaction of levodopa and frequency, and the interaction of frequency and contact pairs on gait parameters. The fixed effects were L-Dopa condition (ON vs. OFF), stimulation frequency (LFS;60 Hz vs. HFS;180 Hz), contact pairs \[1-(R)/1-(L); 2-(R)/2-(L); 3-(R)/3-(L); 4-(R)/4-(L)\], and assistive device (presence vs. absence) and the patient effect was considered random.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91518626|NCT01669122|182911651|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
91654944|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.7032|TWO_SIDED||||||ANCOVA|||Week 11||||0.7032
91518627|NCT01669122|182911651|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
91518628|NCT01669122|182911651|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.97||||||Null hypothesis considered no difference in the treatments being compared.||0.97|0.91|
91643879|NCT00127192|183179638|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-17.7|||<|0.001||95.0|-24.2|-11.2||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-11.2|-24.2|<0.001
91643880|NCT00127192|183179638|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-15.9|||<|0.001||95.0|-22.3|-9.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-9.6|-22.3|<0.001
91643881|NCT03170271|183179642|SUPERIORITY|The null hypothesis was that the exacerbation rate of benralizumab was equal to the exacerbation rate of placebo.|Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Negative binomial|||Comparison of annual exacerbation rates for benralizumab vs placebo (rate ratio). Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the negative binomial model as covariates. The log of each patient's corresponding follow-up time was used as an offset variable in the model to adjust for patients having different follow-up times during which events occurred.||0.65|0.39|<0.0001
91643882|NCT03170271|183179643|SUPERIORITY||LS Mean difference|-8.11|||<|0.0001|TWO_SIDED|95.0|-11.41|-4.82|||Repeated measures analysis||Model: Change from baseline in SGRQ total score = Treatment + baseline SGRQ total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SGRQ total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a mixed-effect model for repeated measures (MMRM) analysis.||-4.82|-11.41|<0.0001
91643883|NCT03170271|183179644|SUPERIORITY||LS Mean difference|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.23|||Repeated measures analysis||Model: Change from baseline in pre-BD FEV1 = Treatment + baseline pre-BD FEV1 + region + number of exacerbations in previous year + maintenance OCS use at baseline + gender + age + visit + treatment by visit.|Change from baseline in pre-BD FEV1 at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||0.23|0.09|<0.0001
91643884|NCT03170271|183179645|SUPERIORITY||LS Mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.27|||Repeated measures analysis||Model: Change from baseline in ACQ-6 score = Treatment + baseline ACQ-6 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in ACQ-6 score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.27|-0.65|<0.0001
91643885|NCT03170271|183179646|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox||A hazard ratio \< 1 favours benralizumab to be associated with a longer time from randomization to the first exacerbation than placebo.|Comparison of time to first asthma exacerbation for benralizumab vs placebo. Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the Cox proportional hazard model as covariates.||0.67|0.40|<0.0001
91643886|NCT03170271|183179647|SUPERIORITY||LS Mean difference|20.11||||0.0031|TWO_SIDED|95.0|6.79|33.44|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in morning PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||33.44|6.79|0.0031
91643887|NCT03170271|183179647|SUPERIORITY||LS Mean Difference|23.09||||0.0008|TWO_SIDED|95.0|9.62|36.55|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in evening PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||36.55|9.62|0.0008
91643888|NCT03170271|183179648|SUPERIORITY||LS Mean difference|5.35||||0.0077|TWO_SIDED|95.0|1.42|9.28|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for physical functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.28|1.42|0.0077
91654945|NCT01656889|183202633|SUPERIORITY_OR_OTHER|||||||0.9366|TWO_SIDED||||||ANCOVA|||||||0.9366
91518629|NCT01669122|182911652|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02||||||Null hypothesis considered no difference in the treatments being compared.||1.02|0.93|
91518630|NCT01669122|182911652|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.99|||||TWO_SIDED|90.0|0.94|1.03||||||Null hypothesis considered no difference in the treatments being compared.||1.03|0.94|
91518631|NCT01669122|182911652|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.92|||||TWO_SIDED|90.0|0.88|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.88|
91518632|NCT01669122|182911653|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
91518633|NCT01669122|182911653|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
91518634|NCT01669122|182911653|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.93|||||TWO_SIDED|90.0|0.9|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.90|
91643889|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|6.8||||0.0022|TWO_SIDED|95.0|2.45|11.14|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to physical health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||11.14|2.45|0.0022
91643890|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|3.07||||0.1741|TWO_SIDED|95.0|-1.36|7.5|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for bodily pain at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.50|-1.36|0.1741
91643891|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|5.62||||0.0009|TWO_SIDED|95.0|2.32|8.92|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for general health perceptions at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||8.92|2.32|0.0009
91643892|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|5.51||||0.0025|TWO_SIDED|95.0|1.95|9.08|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for vitality at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.08|1.95|0.0025
91643893|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|3.12||||0.1583|TWO_SIDED|95.0|-1.22|7.46|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for social functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.46|-1.22|0.1583
91643894|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|2.44||||0.2103|TWO_SIDED|95.0|-1.38|6.27|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to emotional problems at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||6.27|-1.38|0.2103
91643895|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|1.68||||0.2581|TWO_SIDED|95.0|-1.23|4.59|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for mental health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||4.59|-1.23|0.2581
91643896|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|2.32||||0.0022|TWO_SIDED|95.0|0.84|3.81|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 physical health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||3.81|0.84|0.0022
91643897|NCT03170271|183179648|SUPERIORITY||LS Mean Difference|0.87||||0.2751|TWO_SIDED|95.0|-0.7|2.44|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 mental health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||2.44|-0.70|0.2751
91643898|NCT03170271|183179649|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0233|TWO_SIDED|95.0|1.06|2.25|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.25|1.06|0.0233
91643899|NCT03170271|183179649|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0401|TWO_SIDED|95.0|1.02|2.16|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Important Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.16|1.02|0.0401
91643900|NCT03170271|183179650|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.47|2.86|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.86|1.47|<0.0001
91643901|NCT03170271|183179650|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0003|TWO_SIDED|95.0|1.77|6.7|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||6.70|1.77|0.0003
91643902|NCT03170271|183179650|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.48|2.87|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.87|1.48|<0.0001
91643903|NCT03170271|183179650|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|2.02|4.51|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||4.51|2.02|<0.0001
91643904|NCT03170271|183179651|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.62|-0.68|||Repeated measures analysis||Model: Change from baseline in average PSIA score (top 3 ranked) =Treatment + baseline average PSIA score (top 3 ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score for the average of top 3 ranked symptoms/impairments at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.68|-1.62|<0.0001
91643905|NCT03170271|183179651|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.66|||Repeated measures analysis||Model: Change from baseline in PSIA score (top ranked) =Treatment + baseline PSIA score (top ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score of top ranked symptom/impairment at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.66|-1.64|<0.0001
91643906|NCT03170271|183179652|SUPERIORITY||LS Mean difference|-8.91||||0.0204|TWO_SIDED|95.0|-16.42|-1.4|||Repeated measures analysis||Model: Change from baseline in SNOT-22 total score = Treatment + baseline SNOT-22 total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SNOT-22 total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-1.40|-16.42|0.0204
91643907|NCT02701049|183179669|OTHER|Among 109,994 patients who entered the ED during Mode 1, 19,742 had SOGI collected (18%). Among 88,143 patients who entered the ED during Mode 2, 3,630 had SOGI collected (4%).||||||||||||||||Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.|Results were compared to historical control population from an electronic health record database, no other data were collected for these participants.|||
91643908|NCT01612780|183179687|SUPERIORITY||||||<|0.0001||||||Values of p \<0.05 were deemed statistically significant.|t-test, 2 sided|||Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.||||<0.0001
91643909|NCT03466060|183179690|SUPERIORITY||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.23|||TWO_SIDED|95.0|-6.4|2.3||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|bayesian multivariate hierarachical||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||2.3|-6.4|
91643910|NCT03466060|183179690|SUPERIORITY||Posertior Mean Difference|-2.5|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.8|1.7||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|5-minute Follow-up Analysis||1.7|-6.8|
91643911|NCT03466060|183179690|SUPERIORITY||Posterior Mean Difference|-2.7|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-6.9|1.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian multivariate hierarchical model||Posterior mean difference was calculated as Test-Control.|45-Minute Follolw-up Analysis||1.5|-6.9|
91643912|NCT03466060|183179690|SUPERIORITY||Posterior Mean Difference|-2.5|STANDARD_DEVIATION|2.01|||TWO_SIDED|95.0|-6.5|1.4|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||1.4|-6.5|
91643913|NCT03466060|183179690|SUPERIORITY||Posterior Mean Difference|-1.1|STANDARD_DEVIATION|2.28|||TWO_SIDED|95.0|-5.8|3.1|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||3.1|-5.8|
91643914|NCT03466060|183179690|SUPERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-0.7|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-5.0|3.6|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|5-Minute Follow-up Analysis||3.6|-5.0|
91643915|NCT03466060|183179690|NON_INFERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-2.0|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.4|2.3|||Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|45-Minute Follow-up Analysis||2.3|-6.4|
91643916|NCT03466060|183179690|SUPERIORITY||Posterior Mean Difference|-1.5|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-5.8|2.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Mutlivariate Hiearachical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||2.5|-5.8|
91643917|NCT01610284|183179719|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.67|0.89|||Log Rank|||FAS-Full population||0.89|0.67|<0.001
91643918|NCT01610284|183179719|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.8||||0.003|TWO_SIDED|95.0|0.68|0.94|||Log Rank|||FAS-Main cohort||0.94|0.68|0.003
91643919|NCT01610284|183179719|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.76||||0.015|TWO_SIDED|95.0|0.6|0.97|||Log Rank|||FAS-PI3K pathway activated||0.97|0.60|0.015
91643920|NCT01610284|183179719|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.03||||||FAS-PI3K pathway non-activated||1.03|0.67|
91643921|NCT01610284|183179719|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.52|0.94||||||FAS-PI3K pathway unknown||0.94|0.52|
91643922|NCT01610284|183179720|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.87||||0.045|TWO_SIDED|95.0|0.74|1.02|||Log Rank|||FAS-Full population||1.02|0.74|0.045
91643923|NCT01610284|183179720|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.91||||0.144|TWO_SIDED|95.0|0.75|1.09|||Log Rank|||FAS-Main cohort||1.09|0.75|0.144
91643924|NCT01610284|183179720|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.61|1.08||||||FAS-PI3K pathway activated||1.08|0.61|
91643925|NCT01610284|183179720|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.77|1.24||||||FAS-PI3K pathway non-activated||1.24|0.77|
91643926|NCT01610284|183179720|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.06||||||FAS-PI3K pathway unknown||1.06|0.52|
91643927|NCT01856257|183179731|SUPERIORITY||Mean Difference (Final Values)|3.512||||0.544|TWO_SIDED|95.0|-7.999|15.024|||Mixed Models Analysis||The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.|||15.024|-7.999|0.544
91643928|NCT01856257|183179731|SUPERIORITY||Mean Difference (Final Values)|4.82||||0.531|TWO_SIDED|95.0|-10.481|20.121|||Mixed Models Analysis||P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.|||20.121|-10.481|0.531
91643929|NCT00442338|183179762|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01||||0.871|TWO_SIDED|95.0|-0.07|0.08|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the least square (LS) means of time weighted average change FEV1 (0-60 min) using an Analysis of Covariance (ANCOVA) model.||0.08|-0.07|0.871
91643930|NCT00442338|183179762|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.794|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.06|-0.08|0.794
91643931|NCT00442338|183179762|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.675|TWO_SIDED|95.0|-0.06|0.09|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.09|-0.06|0.675
91643932|NCT05674721|183179789|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per Food and Drug Administration (FDA) requirements if the 90 percent (%) confidence intervals (CIs) for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|95.13|||||TWO_SIDED|90.0|88.31|102.47||||||||102.47|88.31|
91643933|NCT05674721|183179790|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.51|||||TWO_SIDED|90.0|93.54|112.35||||||||112.35|93.54|
91643934|NCT05674721|183179791|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.15|||||TWO_SIDED|90.0|96.76|101.61||||||||101.61|96.76|
91643935|NCT05674721|183179792|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.62|||||TWO_SIDED|90.0|98.15|107.3||||||||107.30|98.15|
91643936|NCT05674721|183179793|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.2|||||TWO_SIDED|90.0|96.82|101.63||||||||101.63|96.82|
91643937|NCT05674721|183179794|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.73|||||TWO_SIDED|90.0|98.31|107.34||||||||107.34|98.31|
91643938|NCT04466956|183179819|OTHER|Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|||||<|0.01|TWO_SIDED|95.0||||Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|t-test, 1 sided|||Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.||||<0.01
91643939|NCT00091507|183179820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.28|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|||||1.13|0.66|0.28
91643940|NCT00091507|183179821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.3|1.07|||Regression, Logistic|||||1.07|0.30|0.08
91643941|NCT00091507|183179822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Logistic|||||1.23|0.43|0.24
91643942|NCT00091507|183179823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.27|TWO_SIDED|95.0|0.4|1.29|||Regression, Logistic|||||1.29|0.40|0.27
91643943|NCT00091507|183179824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85|||Regression, Logistic|||||0.85|0.27|0.01
91643944|NCT00203931|183179827|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
91643945|NCT00203931|183179828|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon-Gehan test|||||||0.91
91643946|NCT00203931|183179829|SUPERIORITY_OR_OTHER|||||||0.24|||||||Fisher Exact|||||||0.24
91643947|NCT00203931|183179830|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon-Gehan test|||||||0.046
91643948|NCT00203931|183179831|SUPERIORITY_OR_OTHER|||||||0.029|||||||Log Rank|||||||0.029
91643949|NCT03506425|183179832|OTHER|||||||0.32|||||||t-test, 2 sided|||||||0.32
91643950|NCT03506425|183179833|OTHER|||||||0.08|||||||ANOVA|||||||0.08
91643951|NCT03506425|183179834|OTHER|||||||0.83|||||||ANOVA|||||||0.83
91643952|NCT02181075|183179843|SUPERIORITY|||||||0.024||||||Not adjusted for multiple comparisons. A priori threshold \< 0.05|t-test, 2 sided|95% confidence interval (CI)||A paired t-test was used for Part I (Arm 1) only. Analysis only applies to Part I (Arm 1) because only this study arm has matched Post-LTLD (i.e. post-drug alone) and Post-LTLD+FUS biopsy samples obtained from the same liver tumours before and after targeted drug delivery. In Part II of the study design in which drug delivery occurred completely non-invasively, no Post-LTLD tissue sample is obtained and only a single tumour biopsy is obtained following drug delivery (Post-LTLD+FUS).||||0.024
91643953|NCT04150107|183179849|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|Least mean squares||||<|0.9223|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9223
91643954|NCT04150107|183179850|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.8871|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.8871
91643955|NCT04150107|183179851|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9641|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9641
91643956|NCT04150107|183179852|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.7922|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.7922
91643957|NCT04150107|183179853|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9898|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9898
91643958|NCT04150107|183179854|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.5165|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.5165
91643959|NCT00440193|183179858|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events was calculated to give a power of 90% to prove that rivaroxaban is at least as effective as the comparator, considering a non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided α=0.05). A mean incidence for the primary efficacy outcome of 3% was expected and at least 1465 participants per group were determined to be necessary. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|0.68|STANDARD_ERROR_OF_MEAN|0.2179|<|0.0001||95.0|0.44|1.04|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.04|0.44|< 0.0001
91654946|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.9853|TWO_SIDED||||||ANCOVA|||Week 01||||0.9853
91654947|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.7083|TWO_SIDED||||||ANCOVA|||Week 02||||0.7083
91518635|NCT01669122|182911654|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2208|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.2208
91643960|NCT00440193|183179859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.1616||0.044||95.0|0.53|0.99||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.99|0.53|0.044
91643961|NCT00440193|183179860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|STANDARD_ERROR_OF_MEAN|0.1828||0.027||95.0|0.47|0.95||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.95|0.47|0.027
91643962|NCT00440193|183179862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.1204||0.77||95.0|0.76|1.22||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.22|0.76|0.77
91643963|NCT03409328|183179923|OTHER||F|38.44|||<|0.001|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||<.001
91643964|NCT03409328|183179924|OTHER||F|6.69||||0.013|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.013
91643965|NCT03409328|183179925|OTHER||F|5.07||||0.029|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.029
91643966|NCT03409328|183179926|OTHER||F|0.38||||0.542|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.542
91643967|NCT03409328|183179927|OTHER||F|3.12||||0.084|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is internalized stigma.||||.084
91643968|NCT03409328|183179927|OTHER||F|0.67||||0.417|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is identity affirmation.||||.417
91643969|NCT03930615|183179932|SUPERIORITY||Treatment Difference|-16.1||||0.0005|TWO_SIDED|95.0|-25.8|-6.5||A one-sided p-value ≤0.0249 was used for declaring statistical significance|Mantel Haenszel|Stratum adjusted|Letermovir minus placebo|It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection.|95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-6.5|-25.8|0.0005
91643970|NCT03930615|183179933|OTHER||Difference in Percentage|-4.4|||||TWO_SIDED|95.0|-11.8|4.7|||||Letermovir minus Placebo||Miettinen \& Nurminen method|4.7|-11.8|
91643971|NCT03930615|183179934|OTHER||Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|8.6|||||Letermovir minus Placebo||Miettinen \& Nurminen method|8.6|-2.7|
91643972|NCT03930615|183179935|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
91643973|NCT03930615|183179936|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
91643974|NCT03930615|183179939|SUPERIORITY||Treatment difference|-14.1||||0.0012|TWO_SIDED|95.0|-23.3|-5.0|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-5.0|-23.3|0.0012
91643975|NCT03930615|183179940|SUPERIORITY||Treatment Difference|-5.7||||0.1494|TWO_SIDED|95.0|-16.5|5.1|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.1|-16.5|0.1494
91643976|NCT03930615|183179941|SUPERIORITY||Treatment difference|0.7||||0.6244|TWO_SIDED|95.0|-3.8|5.3|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.3|-3.8|0.6244
91643977|NCT03930615|183179942|SUPERIORITY||Treatment Difference|0.3||||0.5264|TWO_SIDED|95.0|-7.9|8.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|8.4|-7.9|0.5264
91643978|NCT02864953|183179945|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.415|TWO_SIDED|95.0|0.8|1.71||P-value was analyzed by ordinal logistic regression adjusting for covariates: region, and IRT stratification factors including rtPA usage (yes/no), thrombectomy usage (yes/no), use of ASPECTS for screening (yes/no), baseline NIHSS (\<=20 vs. \>20).|Regression, Logistic|||||1.71|0.80|=0.4150
91643979|NCT02864953|183179947|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.7413|TWO_SIDED|95.0|0.72|1.6||A logistic regression model was used to estimate an odds ratio (and 95% CI) of improvement on the mRS dichotomized as 0-4 vs. 5-6 at Day 90.|Regression, Logistic|||||1.60|0.72|=0.7413
91643980|NCT02864953|183179948|SUPERIORITY||Mean Difference (Final Values)|0.82|||=|0.1242|TWO_SIDED|95.0|-0.23|1.87||Analysis of Variance (ANOVA) was used to compare the two study arms to assess the treatment effects on midline shift.|ANOVA|||||1.87|-0.23|=0.1242
91643981|NCT00981019|183179950|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"Study was exploratory, thus no hypotheses had been formalized beforehand.~To analyze repeated measures outcomes (e.g., effect of the four different statistic scenarios on doctors' recommendation of screening, their judgment of screening's effectiveness, etc.), we used the McNemar chi-square test and the Wilcoxon signed-rank test.~To test for order effects (scenarios were randomly presented)Pearson's chi-square test and the Mann-Whitney U test were used."||||<0.05
91643982|NCT00865306|183179957|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<.05
91643983|NCT00865306|183179958|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<.01
91643984|NCT01461369|183180051|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.68|STANDARD_ERROR_OF_MEAN|3.806||0.0024|TWO_SIDED|95.0|-19.17|-4.19|||Mixed Models Analysis|||||-4.19|-19.17|0.0024
91643985|NCT01461369|183180051|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.58|STANDARD_ERROR_OF_MEAN|3.739||0.0795|TWO_SIDED|95.0|-13.94|0.78|||Mixed Models Analysis|||||0.78|-13.94|0.0795
91643986|NCT01461369|183180052|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.82|STANDARD_ERROR_OF_MEAN|3.552|<|0.0001|TWO_SIDED|95.0|-22.82|-8.83|||Mixed Models Analysis|||||-8.83|-22.82|<0.0001
91643987|NCT01461369|183180052|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.8|STANDARD_ERROR_OF_MEAN|3.481||0.0052|TWO_SIDED|95.0|-16.66|-2.95|||Mixed Models Analysis|||||-2.95|-16.66|0.0052
91643988|NCT01461369|183180053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.43|STANDARD_ERROR_OF_MEAN|3.776||0.0011|TWO_SIDED|95.0|-19.87|-4.99|||Mixed Models Analysis|||||-4.99|-19.87|0.0011
91643989|NCT01461369|183180053|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.56|STANDARD_ERROR_OF_MEAN|3.707||0.1349|TWO_SIDED|95.0|-12.86|1.74|||Mixed Models Analysis|||||1.74|-12.86|0.1349
91643990|NCT01461369|183180054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.24|STANDARD_ERROR_OF_MEAN|3.377||0.0001|TWO_SIDED|95.0|-19.89|-6.59|||ANCOVA|||||-6.59|-19.89|0.0001
91643991|NCT01461369|183180054|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.48|STANDARD_ERROR_OF_MEAN|3.313||0.0248|TWO_SIDED|95.0|-14.0|-0.96|||ANCOVA|||||-0.96|-14.00|0.0248
91643992|NCT01461369|183180055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.63|STANDARD_ERROR_OF_MEAN|3.396||0.0002|TWO_SIDED|95.0|-19.32|-5.94|||ANCOVA|||||-5.94|-19.32|0.0002
91643993|NCT01461369|183180055|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.03|STANDARD_ERROR_OF_MEAN|3.339||0.0363|TWO_SIDED|95.0|-13.6|-0.45|||ANCOVA|||||-0.45|-13.60|0.0363
91643994|NCT01461369|183180056|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.38|STANDARD_ERROR_OF_MEAN|3.441||0.0028|TWO_SIDED|95.0|-17.16|-3.6|||ANCOVA|||||-3.60|-17.16|0.0028
91643995|NCT01461369|183180056|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.46|STANDARD_ERROR_OF_MEAN|3.385||0.1081|TWO_SIDED|95.0|-12.13|1.21|||ANCOVA|||||1.21|-12.13|0.1081
91643996|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|6.116|||<|0.0001|TWO_SIDED|95.0|5.976|6.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||6.255|5.976|<.0001
91643997|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|6.073|||<|0.0001|TWO_SIDED|95.0|5.963|6.183|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||6.183|5.963|<.0001
91643998|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.736|||<|0.0001|TWO_SIDED|95.0|5.605|5.868|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||5.868|5.605|<.0001
91643999|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.792|||<|0.0001|TWO_SIDED|95.0|5.687|5.897|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||5.897|5.687|<.0001
91644000|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.835|||<|0.0001|TWO_SIDED|95.0|5.701|5.969|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||5.969|5.701|<.0001
91644001|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.799|||<|0.0001|TWO_SIDED|95.0|5.694|5.904|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||5.904|5.694|<.0001
91654948|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.6744|TWO_SIDED||||||ANCOVA|||Week 03||||0.6744
91654949|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.2891|TWO_SIDED||||||ANCOVA|||||||0.2891
91654950|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.9923|TWO_SIDED||||||ANCOVA|||Week 05||||0.9923
91654951|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.1775|TWO_SIDED||||||ANCOVA|||Week 06||||0.1775
91654952|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||ANCOVA|||Week 07||||0.499
91644002|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|4.881|||<|0.0001|TWO_SIDED|95.0|4.713|5.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||5.048|4.713|<.0001
91644003|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.844|||<|0.0001|TWO_SIDED|95.0|4.711|4.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||4.977|4.711|<.0001
91644004|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.185|||<|0.0001|TWO_SIDED|95.0|5.021|5.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||5.350|5.021|<.0001
91644005|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.933|||<|0.0001|TWO_SIDED|95.0|4.801|5.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||5.066|4.801|<.0001
91644006|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.014|||<|0.0001|TWO_SIDED|95.0|4.852|5.175|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||5.175|4.852|<.0001
91644007|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.892|||<|0.0001|TWO_SIDED|95.0|4.763|5.02|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||5.020|4.763|<.0001
91644008|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.379||||0.0013|TWO_SIDED|95.0|-0.646|-0.112|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.112|-0.646|0.0013
91644009|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0034|TWO_SIDED|95.0|-0.496|-0.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.065|-0.496|0.0034
91654953|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED||||||ANCOVA|||Week 08||||0.4423
91654954|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED||||||ANCOVA|||Week 09||||0.5138
91644010|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0354|TWO_SIDED|95.0|-0.549|-0.012|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.012|-0.549|0.0354
91644011|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.274||||0.0044|TWO_SIDED|95.0|-0.489|-0.059|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.059|-0.489|0.0044
91644012|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-1.235|||<|0.0001|TWO_SIDED|95.0|-1.539|-0.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.930|-1.539|<.0001
91644013|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.229|||<|0.0001|TWO_SIDED|95.0|-1.475|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.983|-1.475|<.0001
91644014|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.630|-1.230|<.0001
91644015|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.383|-0.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.896|-1.383|<.0001
91644016|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.723|||<|0.0001|TWO_SIDED|95.0|0.436|1.009|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.009|0.436|<.0001
91644017|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.901|||<|0.0001|TWO_SIDED|95.0|0.667|1.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.134|0.667|<.0001
91644018|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.821|||<|0.0001|TWO_SIDED|95.0|0.533|1.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.109|0.533|<.0001
91654955|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANCOVA|||Week 10||||0.3409
91654956|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.6358|TWO_SIDED||||||ANCOVA|||Week 11||||0.6358
91654957|NCT01656889|183202634|SUPERIORITY_OR_OTHER|||||||0.6753|TWO_SIDED||||||ANCOVA|||Week 12||||0.6753
91644019|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.907|||<|0.0001|TWO_SIDED|95.0|0.675|1.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.140|.675|<.0001
91644020|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.133||||0.8291|TWO_SIDED|95.0|-0.453|0.188|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.188|-0.453|.8291
91644021|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.048||||0.9997|TWO_SIDED|95.0|-0.308|0.213|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.213|-0.308|0.9997
91644022|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.172||||0.5755|TWO_SIDED|95.0|-0.145|0.488|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.488|-0.145|0.5755
91644023|NCT03692078|183180075|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.042||||0.9999|TWO_SIDED|95.0|-0.217|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.301|-0.217|0.9999
91644024|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.629|||<|0.0001|TWO_SIDED|95.0|2.317|2.94|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||2.940|2.317|<.0001
91644025|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.632|||<|0.0001|TWO_SIDED|95.0|2.321|2.943|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||2.943|2.321|<.0001
91644026|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.006|||<|0.0001|TWO_SIDED|95.0|1.714|2.298|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||2.298|1.714|<.0001
91644027|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.143|||<|0.0001|TWO_SIDED|95.0|1.847|2.44|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||2.440|1.847|<.0001
91654958|NCT01656889|183202635|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier Survival analysis|||||||< 0.05
91654959|NCT02114307|183202640|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91654960|NCT02114307|183202641|SUPERIORITY|||||||0.0023|||||||t-test, 2 sided|||Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0023
91644028|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|1.987|||<|0.0001|TWO_SIDED|95.0|1.69|2.284|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||2.284|1.690|<.0001
91644029|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.261|||<|0.0001|TWO_SIDED|95.0|1.964|2.559|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||2.559|1.964|<.0001
91644030|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.263||||0.1658|TWO_SIDED|95.0|-0.635|0.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||0.109|-0.635|0.1658
91644031|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.659||||0.0007|TWO_SIDED|95.0|-1.036|-0.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||-0.282|-1.036|0.0007
91644032|NCT03692078|183180077|NON_INFERIORITY|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.302||||0.1055|TWO_SIDED|95.0|-0.667|0.064|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||0.064|-0.667|0.1055
91644033|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.243||||0.204|TWO_SIDED|95.0|-0.617|0.132|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||0.132|-0.617|0.2040
91644034|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.244||||0.1829|TWO_SIDED|95.0|-0.603|0.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||0.116|-0.603|0.1829
91644035|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.248||||0.1801|TWO_SIDED|95.0|-0.612|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||0.115|-0.612|0.1801
91644036|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.622||||0.0391|TWO_SIDED|95.0|-1.225|-0.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.019|-1.225|0.0391
91654961|NCT02114307|183202641|SUPERIORITY|||||||0.0815|||||||t-test, 2 sided|||Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0815
91654962|NCT02114307|183202642|SUPERIORITY|||||||0.127|||||||t-test, 1 sided|||||||0.127
91518636|NCT01669122|182911654|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5695|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.25|-0.25|0.5695
91518637|NCT01669122|182911654|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0063|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.0063
91518638|NCT02962908|182911657|OTHER|Inequality test.||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||0.45
91518639|NCT02962908|182911657|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||<0.001
91518640|NCT02962908|182911657|OTHER|inequality test||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||0.88
91518641|NCT02962908|182911657|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||<0.001
91518642|NCT02962908|182911657|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||0.21
91518643|NCT02962908|182911657|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||<0.001
91518644|NCT02962908|182911657|OTHER|inequality test||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.77
91518645|NCT02962908|182911657|OTHER|inequality test||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.004
91518646|NCT02962908|182911657|OTHER|inequality test||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.08
91654963|NCT02275364|183202652|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.28|||<|0.0001|TWO_SIDED|95.0|12.32|18.25||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||18.25|12.32|<0.0001
91518647|NCT02962908|182911657|OTHER|inequality test||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.38
91518648|NCT02962908|182911657|OTHER|inequality test||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.49
91518649|NCT02962908|182911657|OTHER|inequality test||||||0.156|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.156
91518650|NCT02962908|182911657|OTHER|inequality test||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL-2 from day 0 to day 42.||||0.125
91518651|NCT02962908|182911657|OTHER|inequality test||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91518652|NCT02962908|182911657|OTHER|inequality test||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.72
91518653|NCT02962908|182911657|OTHER|inequality test||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.34
91518654|NCT02962908|182911658|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.62
91518655|NCT02962908|182911658|OTHER|inequality test||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.030
91518656|NCT02962908|182911658|OTHER|inequality test||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.87
91518657|NCT02962908|182911658|OTHER|inequality test||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.075
91518658|NCT02962908|182911658|OTHER|inequality test||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||0.076
91518659|NCT02962908|182911658|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||<0.001
91518660|NCT02962908|182911658|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
91518661|NCT02962908|182911658|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
91518662|NCT02962908|182911658|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
91518663|NCT02962908|182911658|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
91518664|NCT02962908|182911658|OTHER|inequality||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
91518665|NCT02962908|182911658|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
91518666|NCT02962908|182911658|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.21
91644037|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.1864|TWO_SIDED|95.0|-1.096|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.119|-1.096|0.1864
91644038|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.037|-1.246|0.0310
91644039|NCT03692078|183180077|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.037|-1.246|0.0310
91644040|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.891|||<|0.0001|TWO_SIDED|95.0|-3.58|-2.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.202|-3.580|<.0001
91644041|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.291|||<|0.0001|TWO_SIDED|95.0|-3.985|-2.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.597|-3.985|<.0001
91644042|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.93|||<|0.0001|TWO_SIDED|95.0|-3.605|-2.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.255|-3.605|<.0001
91644043|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.875|||<|0.0001|TWO_SIDED|95.0|-3.559|-2.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.190|-3.559|<.0001
91644044|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|1.604|2.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.896|1.604|<.0001
91654964|NCT02275364|183202653|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93||||0.7366|TWO_SIDED|95.0|-6.43|4.57||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||4.57|-6.43|0.7366
91518667|NCT02962908|182911658|OTHER|inequality test||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.48
91518668|NCT02962908|182911658|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.62
91644045|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.391|||<|0.0001|TWO_SIDED|95.0|1.737|3.046|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||3.046|1.737|<.0001
91644046|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.231|||<|0.0001|TWO_SIDED|95.0|1.582|2.879|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.879|1.582|<.0001
91644047|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.509|||<|0.0001|TWO_SIDED|95.0|1.857|3.162|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.162|1.857|<.0001
91644048|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.019||||1|TWO_SIDED|95.0|-0.743|0.705|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.705|-0.743|1.0000
91644049|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.411||||0.5639|TWO_SIDED|95.0|-1.142|0.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.320|-1.142|0.5639
91644050|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||1|TWO_SIDED|95.0|-0.771|0.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.656|-0.771|1.0000
91644051|NCT03692078|183180077|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.006||||1|TWO_SIDED|95.0|-0.721|0.732|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.732|-0.721|1.0000
91644052|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.691|||<|0.0001|TWO_SIDED|95.0|2.519|2.863|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.863|2.519|<.0001
91644053|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.718|||<|0.0001|TWO_SIDED|95.0|2.546|2.89|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.890|2.546|<.0001
91654965|NCT02275364|183202654|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1533.74||||0.0004|TWO_SIDED|95.0|794.16|2273.32||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2273.32|794.16|0.0004
91518669|NCT02962908|182911658|OTHER|inequality||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.23
91518670|NCT02962908|182911659|OTHER|inequality test||||||0.8|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
91518671|NCT02962908|182911659|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
91518672|NCT02962908|182911659|OTHER|inequality test||||||0.23|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.23
91518673|NCT02962908|182911659|OTHER|||||||0.056|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.056
91518674|NCT02962908|182911659|OTHER|inequality test||||||0.74|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.74
91518675|NCT02962908|182911659|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
91518676|NCT02962908|182911659|OTHER|inequality test||||||0.34|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.34
91518677|NCT02962908|182911659|OTHER|inequality test||||||0.01|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.010
91518678|NCT02962908|182911659|OTHER|inequality test||||||0.096|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.096
91518679|NCT02962908|182911659|OTHER|inequality test||||||0.049|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 180.Differences considered significant if p-value \<0.05.||||0.049
91654966|NCT02275364|183202655|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46||||0.7278|TWO_SIDED|95.0|-3.06|2.14||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2.14|-3.06|0.7278
91518680|NCT02962908|182911659|OTHER|inequality test||||||0.91|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.91
91518681|NCT02962908|182911659|OTHER|||||||0.39|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.39
91518682|NCT02962908|182911659|OTHER|inequality test||||||0.94|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.94
91518683|NCT02962908|182911659|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||<0.001
91518684|NCT02962908|182911659|OTHER|inequality test||||||0.044|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.044
91518685|NCT02962908|182911659|OTHER|inequality test||||||0.98|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.98
91518686|NCT02962908|182911659|OTHER|inequality test||||||0.48|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.48
91518687|NCT02962908|182911659|OTHER|inequality test||||||0.28|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.28
91518688|NCT02962908|182911659|OTHER|inequality test||||||0.7|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.70
91518689|NCT02962908|182911659|OTHER|inequality test||||||0.175|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.175
91518690|NCT02962908|182911659|OTHER|inequality test||||||0.24|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.24
91518691|NCT02962908|182911659|OTHER|inequality test||||||0.8|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
91518692|NCT02962908|182911659|OTHER|inequality test||||||0.023|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.023
91518693|NCT02962908|182911659|OTHER|inequality test||||||0.015|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.015
91518694|NCT02962908|182911659|OTHER|inequality test||||||0.81|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.81
91518695|NCT02962908|182911659|OTHER|inequality test||||||0.34|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.34
91518696|NCT02962908|182911659|OTHER|inequality test||||||0.3|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.30
91518697|NCT02962908|182911659|OTHER|inequality test||||||0.105|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.105
91518698|NCT02962908|182911659|OTHER|inequality test||||||0.38|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.38
91518699|NCT02962908|182911659|OTHER|inequality test||||||0.44|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.44
91518700|NCT02962908|182911659|OTHER|inequality test||||||0.58|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.58
91518701|NCT02962908|182911659|OTHER|inequality test||||||0.43|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.43
91644054|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.415|||<|0.0001|TWO_SIDED|95.0|2.252|2.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.577|2.252|<.0001
91518702|NCT02962908|182911660|OTHER|inequality test||||||0.25|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||0.25
91518703|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||1.0
91518704|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL-2 at day 42||||1.00
91518705|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||1.00
91518706|NCT02962908|182911660|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||<0.001
91518707|NCT02962908|182911660|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||<0.001
91518708|NCT02962908|182911660|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 42||||<0.001
91518709|NCT02962908|182911660|OTHER|inequality test||||||0.31|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||0.31
91518710|NCT02962908|182911660|OTHER|inequality test||||||0.48|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||0.48
91518711|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||1.00
91518712|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||1.00
91518713|NCT02962908|182911660|OTHER|inequality test||||||0.59|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||0.59
91518714|NCT02962908|182911660|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||<0.001
91518715|NCT02962908|182911660|OTHER|inequality test||||||0.013|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||0.013
91518716|NCT02962908|182911660|OTHER|inequality|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||<0.001
91518717|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||1.00
91518718|NCT02962908|182911660|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
91518719|NCT02962908|182911660|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
91518720|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 42||||1.00
91518721|NCT02962908|182911660|OTHER|inequality test||||||0.29|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||0.29
91518722|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
91518723|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||1.00
91518724|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
91518725|NCT02962908|182911660|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing CD107a at day 180||||1.00
91518726|NCT02962908|182911661|OTHER|inequality test||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.59
91518727|NCT02962908|182911661|OTHER|inequality test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.001
91518728|NCT02962908|182911661|OTHER|inequality test||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||0.61
91518729|NCT02962908|182911661|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||<0.001
91518730|NCT02962908|182911662|OTHER|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||0.113
91518731|NCT02962908|182911662|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||<0.001
91518732|NCT02962908|182911662|OTHER|||||||0.399|||||||Chi-squared|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||0.399
91644055|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.44|||<|0.0001|TWO_SIDED|95.0|2.276|2.603|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.603|2.276|<.0001
91644056|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.583|||<|0.0001|TWO_SIDED|95.0|2.417|2.748|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.748|2.417|<.0001
91644057|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.591|||<|0.0001|TWO_SIDED|95.0|2.426|2.757|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.757|2.426|<.0001
91644058|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.107|||<|0.0001|TWO_SIDED|95.0|0.901|1.314|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.314|0.901|<.0001
91644059|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.017|||<|0.0001|TWO_SIDED|95.0|0.81|1.225|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.225|0.810|<.0001
91644060|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.828|||<|0.0001|TWO_SIDED|95.0|1.624|2.031|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.031|1.624|<.0001
91644061|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.782|||<|0.0001|TWO_SIDED|95.0|1.577|1.988|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.988|1.577|<.0001
91644062|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.350|-0.750|<.0001
91518733|NCT02962908|182911662|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||<0.001
91518734|NCT02962908|182911664|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42 post-vaccination.||||<0.001
91518735|NCT02962908|182911664|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42.||||<0.001
91644063|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.051|-0.65|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.650|-1.051|<.0001
91644064|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.276||||0.1608|TWO_SIDED|95.0|-0.609|0.057|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.057|-0.609|0.1608
91644065|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.278||||0.1575|TWO_SIDED|95.0|-0.613|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.056|-0.613|0.1575
91644066|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.108||||0.9728|TWO_SIDED|95.0|-0.442|0.226|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.226|-0.442|0.9728
91644067|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.127||||0.9262|TWO_SIDED|95.0|-0.461|0.208|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.208|-0.461|0.9262
91644068|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.584|||<|0.0001|TWO_SIDED|95.0|-1.963|-1.204|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.204|-1.963|<.0001
91644069|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.701|||<|0.0001|TWO_SIDED|95.0|-2.081|-1.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.320|-2.081|<.0001
91644070|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.863|||<|0.0001|TWO_SIDED|95.0|-1.237|-0.489|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.489|-1.237|<.0001
91654967|NCT02275364|183202656|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|191.72||||0.1639|TWO_SIDED|95.0|-78.62|462.06||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||462.06|-78.62|0.1639
91518736|NCT02962908|182911664|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
91518737|NCT02962908|182911664|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
91518738|NCT02962908|182911667|OTHER|||||||0.662|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.662
91644071|NCT03692078|183180079|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.312|-0.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.560|-1.312|<.0001
91644072|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.47|||<|0.0001|TWO_SIDED|95.0|3.31|3.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.630|3.310|<.0001
91644073|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.508|||<|0.0001|TWO_SIDED|95.0|3.348|3.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.668|3.348|<.0001
91644074|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.891|||<|0.0001|TWO_SIDED|95.0|2.741|3.042|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.042|2.741|<.0001
91644075|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.873|||<|0.0001|TWO_SIDED|95.0|2.719|3.027|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.027|2.719|<.0001
91644076|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.928|||<|0.0001|TWO_SIDED|95.0|2.775|3.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.082|2.775|<.0001
91644077|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.896|||<|0.0001|TWO_SIDED|95.0|2.742|3.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.049|2.742|<.0001
91644078|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.864|||<|0.0001|TWO_SIDED|95.0|0.672|1.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.055|0.672|<.0001
91518739|NCT02962908|182911667|OTHER|||||||0.168|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.168
91518740|NCT02962908|182911668|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||The study was not powered to detected statistical significant differences in this outcome.|||>0.05
91706195|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.325||0.8613|TWO_SIDED|90.0|-0.48|0.6|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.60|-0.48|0.8613
91706196|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.341||0.5245|TWO_SIDED|90.0|-0.35|0.78|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.78|-0.35|0.5245
91706197|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.334||0.8917|TWO_SIDED|90.0|-0.6|0.51|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.51|-0.60|0.8917
91706198|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.339||0.1695|TWO_SIDED|90.0|-0.09|1.03|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-0.09|0.1695
91706199|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.329||0.5339|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5339
91706200|NCT00938587|183306682|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.332||0.452|TWO_SIDED|90.0|-0.3|0.8|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.30|0.4520
91706201|NCT03763058|183306708|SUPERIORITY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|4.19||0.012|TWO_SIDED|95.0|||||Sign test|||||||0.012
91706202|NCT03763058|183306709|SUPERIORITY||Mean Difference (Final Values)|-5.45|STANDARD_DEVIATION|15.52||0.002|TWO_SIDED|95.0|||||Sign test|||||||0.002
91518741|NCT02962908|182911668|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||Study not powered to detect statistically significant differences|||>0.05
91518742|NCT02962908|182911669|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison in the duration of symptoms between treatment group and corresponding placebo.||||0.513
91518743|NCT02962908|182911669|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of the duration of symptoms between treatment group and corresponding placebo.||||0.578
91518744|NCT02962908|182911669|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison of total symptom score between treatment group and corresponding placebo.||||0.513
91518745|NCT02962908|182911669|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total symptom score between treatment group and corresponding placebo.||||0.200
91706203|NCT03763058|183306710|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|2.71||0.045|TWO_SIDED|95.0|||||Sign test|||||||0.045
91706204|NCT03763058|183306711|SUPERIORITY||Mean Difference (Final Values)|-3.65|STANDARD_DEVIATION|4.59|<|0.001|TWO_SIDED|95.0|||||Sign test|||||||<0.001
91706205|NCT03763058|183306712|SUPERIORITY||Mean Difference (Final Values)|-4.15|STANDARD_DEVIATION|5.1|<|0.001|TWO_SIDED|95.0|||||Sign test|||Total HAD score||||<0.001
91518746|NCT02962908|182911669|OTHER|||||||0.658|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.658
91518747|NCT02962908|182911669|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.640
91518748|NCT02962908|182911669|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.127
91518749|NCT02962908|182911669|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.201
91518750|NCT02962908|182911670|OTHER|inequality test||||||0.85|||||||Chi-squared|||comparison between groups on day 42||||0.85
91518751|NCT02962908|182911670|OTHER|inequality test||||||0.042|||||||Fisher Exact|||comparison between groups on day 42||||0.042
91518752|NCT02962908|182911670|OTHER|inequality test||||||0.69|||||||Fisher Exact|||comparison between groups on day 180||||0.69
91518753|NCT02962908|182911670|OTHER|inequality test||||||0.198|||||||Fisher Exact|||comparison between groups on day 180||||0.198
91518754|NCT02962908|182911670|OTHER|inequality test||||||0.092|||||||Chi-squared|||comparison between groups on day 42||||0.092
91706206|NCT02759835|183306713|OTHER|||||||0.56|||||||Kaplan-Meier|||||||0.56
91706207|NCT02759835|183306715|OTHER|||||||0.4|||||||Kaplan-Meier|||||||0.40
91706208|NCT00055497|183306739|SUPERIORITY_OR_OTHER|||||||0.142|||||||Log Rank|||||||0.142
91706209|NCT00055497|183306740|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||||||0.029
91706210|NCT00055497|183306741|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||Week 24||||0.330
91706211|NCT00055497|183306741|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||Week 24||||0.001
91706212|NCT00055497|183306741|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
91706213|NCT00055497|183306741|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|||Week 56||||0.044
91706214|NCT00055497|183306742|SUPERIORITY_OR_OTHER|||||||0.191|||||||Fisher Exact|||Week 24||||0.191
91706215|NCT00055497|183306742|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||Week 24||||0.003
91706216|NCT00055497|183306742|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
91706217|NCT00055497|183306742|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||Week 56||||0.004
91706218|NCT00055497|183306743|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
91706219|NCT00048165|183306748|SUPERIORITY_OR_OTHER||percent mean difference|-12.0||||0.007|TWO_SIDED|95.0|-20.9|-3.3|||Cochran-Mantel-Haenszel|||||-3.3|-20.9|0.007
91706220|NCT00048165|183306749|SUPERIORITY_OR_OTHER||percent mean difference|-8.6||||0.063|TWO_SIDED|95.0|-17.7|0.5|||Cochran-Mantel-Haenszel|||||0.5|-17.7|0.063
91706221|NCT00048165|183306752|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 6 months were presented||||0.0005
91706222|NCT00048165|183306752|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 12 months were presented||||0.0008
91706223|NCT00678470|183306774|OTHER||Correlation|1.0||||0.0003|TWO_SIDED||||||Fisher Exact||||Using Fisher's non-parametric test of associations, correlations were determined between the patients who were intralesional responders with their response at ‡70% change in PASI score.|||0.0003
91706224|NCT00508157|183306776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.28|||||TWO_SIDED|95.0|-19.14|-2.66|||ANCOVA|ANCOVA model: log of on-treatment to baseline ratio = log of baseline value, treatment, previous antipsychotic.|Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1.|Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16||-2.66|-19.14|
91706225|NCT00508157|183306777|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|A relative risk \< 1 favors Aripiprazole over Control Group.||null hypothesis: no difference between Aripiprazole and Control Group||1.06|0.54|
91706226|NCT02134353|183306801|SUPERIORITY||Mean Difference (Net)|54.0||||0.02|TWO_SIDED|95.0|8.0|100.0|||Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF (baseline observation carried forward). Data collected at 6, 14 and 26 weeks.|||100|8|0.020
91706227|NCT02134353|183306802|SUPERIORITY||Mean Difference (Net)|40.0||||0.128|TWO_SIDED|95.0|-12.0|92.0||Missing data for withdrawals due to safety/efficacy imputed using BOCF. Data collected at 6,14 and 26 weeks.|Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF. Data collected at 6, 14 and 26 weeks.|||92|-12|0.128
91706228|NCT02134353|183306803|SUPERIORITY||Cox Proportional Hazard|1.14||||0.629|TWO_SIDED|95.0|0.671|1.936|||Regression, Cox|||||1.936|0.671|0.629
91706229|NCT02134353|183306804|SUPERIORITY||Rate ratio|0.75||||0.673|TWO_SIDED|95.0|0.198|2.846|||Negative binomial model|||||2.846|0.198|0.673
91518755|NCT02962908|182911670|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparison of groups on day 42||||<0.001
91518756|NCT02962908|182911670|OTHER|inequality test||||||0.27|||||||Chi-squared|||comparison of groups on day 180||||0.27
91706230|NCT02134353|183306805|SUPERIORITY||Rate ratio|1.273||||0.735|TWO_SIDED|95.0|0.315|5.154|||Negative binomial model|||||5.154|0.315|0.735
91706231|NCT02134353|183306806|SUPERIORITY||Rate ratio|1.545||||0.055|TWO_SIDED|95.0|0.99|2.411|||Negative binomial model|||Patients withdrawing early without an exacerbation had rate imputed based on number of exacerbations in 12 months prior to screening.||2.411|0.990|0.055
91706232|NCT02134353|183306806|SUPERIORITY||Rate ratio|1.357||||0.246|TWO_SIDED|95.0|0.81|2.275|||Negative binomial model|||Sensitivity analysis with no imputation of missing data.||2.275|0.810|0.246
91706233|NCT02134353|183306807|SUPERIORITY||Odds Ratio (OR)|1.009||||0.976|TWO_SIDED|95.0|0.555|1.836|||Regression, Logistic|||||1.836|0.555|0.976
91518757|NCT02962908|182911670|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparisons between groups on day 180||||<0.001
91518758|NCT01420848|182911685|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||It was used the Post Hoc and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.||||0.006
91518759|NCT01420848|182911685|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||The statistical significance was p\<0.05.|ANOVA|||"It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days)."||||0.023
91518760|NCT01420848|182911686|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||After ANOVA it was performed Post Hoc Test and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)||||0.012
91706234|NCT02134353|183306808|SUPERIORITY||Mean Difference (Net)|0.259||||0.083|TWO_SIDED|95.0|-0.034|0.551|||Mixed Models Analysis|Missing values due to withdrawal related to safety/efficacy imputed using BOCF||||0.551|-0.034|0.083
91706235|NCT02134353|183306809|SUPERIORITY||Mean Difference (Net)|0.87||||0.453|TWO_SIDED|95.0|-1.406|3.145|||Mixed Models Analysis||Missing values due to withdrawal related to safety/efficacy imputed using BOCF|||3.145|-1.406|0.453
91706236|NCT02134353|183306810|SUPERIORITY||Mean Difference (Net)|87.0||||0.012|TWO_SIDED|95.0|20.0|155.0|||Mixed Models Analysis||Missing data due to withdrawals for reasons related to safety/efficacy imputed using BOCF|||155|20|0.012
91706237|NCT01953432|183306811|OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED||||||||Probability of 0.75 that the OR exceeded 1.00 (OR = 1.01, 95% CI = 0.98-1.05)|||||
91706238|NCT01953432|183306811|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED||||||||Probability of 0.96 that the odds ratio exceeded 1.00 (OR = 1.03, 95% CI = 1.00-1.07)|||||
91706239|NCT01783821|183306815|SUPERIORITY_OR_OTHER|||||||0.02|||||||Type 3 Wald Test|||Overall p-value of the day by treatment interaction from the random effects model using a type 3 Wald test.||||0.02
91706240|NCT01783821|183306816|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||Comparison between the two arms for the 3 categories.||||0.01
91706241|NCT01783821|183306817|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
91706242|NCT01783821|183306818|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
91706243|NCT01783821|183306819|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cox Proportional Hazard, Fine/Gray adj.|||||||0.02
91706244|NCT01783821|183306820|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91706245|NCT01653327|183306841|SUPERIORITY|||||||0.3198|||||||t-test, 2 sided|||||||0.3198
91706246|NCT01653327|183306842|SUPERIORITY|||||||0.3522|||||||t-test, 2 sided|||||||0.3522
91706247|NCT02440854|183306849|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.002
91706248|NCT02440854|183306849|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.014
91706249|NCT02440854|183306849|OTHER|||||||0.246|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.246
91706250|NCT02440854|183306849|OTHER|||||||0.103|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.103
91706251|NCT02440854|183306849|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.004
91706252|NCT02440854|183306849|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91706253|NCT02440854|183306849|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.012
91706254|NCT02440854|183306849|OTHER|||||||0.024|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.024
91706255|NCT02440854|183306849|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.009
91706256|NCT02440854|183306849|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.008
91706257|NCT02440854|183306850|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.027
91706258|NCT02440854|183306850|OTHER|||||||0.03|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.030
91706259|NCT02440854|183306850|OTHER|||||||0.351|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.351
91706260|NCT02440854|183306850|OTHER|||||||0.143|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.143
91706261|NCT02440854|183306850|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.163
91518761|NCT01420848|182911686|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||After ANOVA, the Post Hoc Test was done and the statistical significance was p\<0.05.|ANOVA|||"It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days).~Hypothesis: there is at least one difference among the groups (State Anxiety)."||||0.005
91706262|NCT02440854|183306850|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
91706263|NCT02440854|183306850|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
91706264|NCT02440854|183306850|OTHER|||||||0.036|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.036
91706265|NCT02440854|183306850|OTHER|||||||0.043|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.043
91518762|NCT01962493|182911707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.155||0.1313|TWO_SIDED|95.0|-0.51|0.1||Analysis based on square root transformation. Results back transformed for interpretation.|ANCOVA|Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.|Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment|Null hypothesis stated that there was no difference between treatment groups||0.10|-0.51|0.1313
91706266|NCT02440854|183306850|OTHER|||||||0.04|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.040
91706267|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
91706268|NCT02440854|183306851|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.003
91706269|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
91706270|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
91706271|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
91706272|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91706273|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
91706274|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
91706275|NCT02440854|183306851|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
91706276|NCT02440854|183306851|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.163
91706277|NCT02440854|183306852|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.003
91706278|NCT02440854|183306852|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.009
91706279|NCT02440854|183306852|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.012
91706280|NCT02440854|183306852|OTHER|||||||0.332|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.332
91706281|NCT02440854|183306852|OTHER|||||||0.029|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.029
91706282|NCT02440854|183306852|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
91706283|NCT02440854|183306852|OTHER|||||||0.177|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.177
91706284|NCT02440854|183306852|OTHER|||||||0.436|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.436
91706285|NCT02440854|183306852|OTHER|||||||0.302|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.302
91706286|NCT02440854|183306852|OTHER|||||||0.291|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.291
91706287|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
91706288|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
91706289|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
91706290|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
91706291|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
91706292|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91706293|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
91706294|NCT02440854|183306853|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
91706295|NCT02440854|183306853|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.002
91706296|NCT02440854|183306853|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
91706297|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
91706298|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
91706299|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
91706300|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
91706301|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
91706302|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91644079|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.786|||<|0.0001|TWO_SIDED|95.0|0.592|0.981|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.981|0.592|<.0001
91644080|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.641|||<|0.0001|TWO_SIDED|95.0|0.452|0.829|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.829|0.452|<.0001
91706303|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
91706304|NCT02440854|183306854|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
91706305|NCT02440854|183306854|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.003
91706306|NCT02440854|183306854|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
91644081|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.485|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.680|0.290|<.0001
91644082|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.747|||<|0.0001|TWO_SIDED|95.0|0.562|0.932|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.932|0.562|<.0001
91706307|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
91706308|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
91518763|NCT01951625|182911715|OTHER||Log-Scale mean difference|-0.122|||=|0.1506|TWO_SIDED|90.0|-0.32|0.07|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test at the significance level of 5 percent (%). Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the pooled treatment group and the placebo group is difference of means on the log scale.||0.07|-0.32|= 0.1506
91518764|NCT01951625|182911715|OTHER||Log-Scale mean difference|-0.2494|||=|0.0483|TWO_SIDED|90.0|-0.5|0.0|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0|-0.5|= 0.0483
91706309|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
91706310|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
91706311|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
91706312|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91706313|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
91706314|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
91706315|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
91706316|NCT02440854|183306855|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||<0.001
91706317|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
91706318|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
91706319|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
91644083|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.833|||<|0.0001|TWO_SIDED|95.0|0.645|1.021|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.021|0.645|<.0001
91644084|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.579|||<|0.0001|TWO_SIDED|95.0|-0.889|-0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.268|-0.889|<.0001
91644085|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.635|||<|0.0001|TWO_SIDED|95.0|-0.949|-0.321|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.321|-0.949|<.0001
91644086|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.853|-0.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.231|-0.853|<.0001
91644087|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.924|-0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.301|-0.924|<.0001
91644088|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.606|||<|0.0001|TWO_SIDED|95.0|-2.959|-2.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.253|-2.959|<.0001
91654968|NCT02275364|183202657|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.4621|TWO_SIDED|95.0|-0.03|0.07||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||0.07|-0.03|0.4621
91706320|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
91706321|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
91706322|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91706323|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
91706324|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
91706325|NCT02440854|183306856|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
91706326|NCT02440854|183306856|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.002
91706327|NCT02440854|183306857|OTHER|||||||0.022|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.022
91706328|NCT02440854|183306857|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
91706329|NCT02440854|183306857|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.004
91706330|NCT02440854|183306857|OTHER|||||||0.032|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.032
91706331|NCT02440854|183306857|OTHER|||||||0.066|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.066
91706332|NCT02440854|183306857|OTHER|||||||0.042|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.042
91706333|NCT02440854|183306857|OTHER|||||||0.045|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.045
91706334|NCT02440854|183306857|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.014
91706335|NCT02440854|183306857|OTHER|||||||0.015|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.015
91706336|NCT02440854|183306857|OTHER|||||||0.462|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.462
91644089|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.722|||<|0.0001|TWO_SIDED|95.0|-3.078|-2.366|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.366|-3.078|<.0001
91644090|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.829|||<|0.0001|TWO_SIDED|95.0|-3.177|-2.481|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.481|-3.177|<.0001
91644091|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.024|||<|0.0001|TWO_SIDED|95.0|-3.378|-2.669|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.669|-3.378|<.0001
91644092|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.144|||<|0.0001|TWO_SIDED|95.0|1.811|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.811|<.0001
91644093|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.04|||<|0.0001|TWO_SIDED|95.0|1.701|2.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.379|1.701|<.0001
91644094|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.181|||<|0.0001|TWO_SIDED|95.0|1.846|2.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.516|1.846|<.0001
91644095|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.063|||<|0.0001|TWO_SIDED|95.0|1.725|2.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.400|1.725|<.0001
91706337|NCT02440854|183306858|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
91706338|NCT02440854|183306858|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.004
91706339|NCT02440854|183306858|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.008
91706340|NCT02440854|183306858|OTHER|||||||0.315|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.315
91706341|NCT02440854|183306858|OTHER|||||||0.237|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.237
91706342|NCT02440854|183306858|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
91706343|NCT02440854|183306858|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.002
91706344|NCT02440854|183306858|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.004
91706345|NCT02440854|183306858|OTHER|||||||0.01|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.010
91706346|NCT02440854|183306858|OTHER|||||||0.683|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.683
91706347|NCT02440854|183306859|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.062
91706348|NCT02440854|183306859|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.062
91706349|NCT02440854|183306859|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.027
91706350|NCT02440854|183306859|OTHER|||||||0.17|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.170
91644096|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.117||||0.9705|TWO_SIDED|95.0|-0.256|0.49|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.490|-0.256|0.9705
91644097|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.047||||1|TWO_SIDED|95.0|-0.425|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.332|-0.425|1.0000
91644098|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.106||||0.9835|TWO_SIDED|95.0|-0.475|0.263|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.263|-0.475|0.9835
91644099|NCT03692078|183180081|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.348||||0.0854|TWO_SIDED|95.0|-0.725|0.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.029|-0.725|0.0854
91644100|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.028|||<|0.0001|TWO_SIDED|95.0|2.901|3.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.154|2.901|<.0001
91644101|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.034|||<|0.0001|TWO_SIDED|95.0|2.927|3.141|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.141|2.927|<.0001
91644102|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.603|||<|0.0001|TWO_SIDED|95.0|2.483|2.722|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.722|2.483|<.0001
91644103|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.567|||<|0.0001|TWO_SIDED|95.0|2.465|2.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.670|2.465|<.0001
91644104|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.716|||<|0.0001|TWO_SIDED|95.0|2.595|2.838|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.838|2.595|<.0001
91706351|NCT02440854|183306859|OTHER|||||||0.271|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.271
91706352|NCT02440854|183306859|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.002
91706353|NCT02440854|183306859|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
91524192|NCT00532155|182923509|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.8985|TWO_SIDED|95.0|0.868|1.174|||Stratified log-rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||1.174|0.868|0.8985
91644105|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.643|||<|0.0001|TWO_SIDED|95.0|2.541|2.746|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.746|2.541|<.0001
91644106|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.235|||<|0.0001|TWO_SIDED|95.0|1.083|1.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.386|1.083|<.0001
91644107|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.045|1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.304|1.045|<.0001
91644108|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.219|||<|0.0001|TWO_SIDED|95.0|1.07|1.368|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.368|1.070|<.0001
91644109|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.046|1.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.306|1.046|<.0001
91644110|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.029|1.322|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.322|1.029|<.0001
91644111|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.049|1.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.300|1.049|<.0001
91706354|NCT02440854|183306859|OTHER|||||||0.157|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.157
91706355|NCT02440854|183306859|OTHER|||||||0.064|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.064
91706356|NCT02440854|183306859|OTHER|||||||0.439|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.439
91706357|NCT02440854|183306860|OTHER|||||||0.388|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.388
91644112|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.425|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.181|-0.669|<.0001
91644113|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.467|||<|0.0001|TWO_SIDED|95.0|-0.677|-0.256|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.256|-0.677|<.0001
91644114|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.311||||0.0052|TWO_SIDED|95.0|-0.556|-0.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.066|-0.556|0.0052
91644115|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.391|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.182|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.182|-0.600|<.0001
91644116|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.793|||<|0.0001|TWO_SIDED|95.0|-2.07|-1.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.516|-2.070|<.0001
91644117|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.859|||<|0.0001|TWO_SIDED|95.0|-2.098|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.098|<.0001
91644118|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.809|||<|0.0001|TWO_SIDED|95.0|-2.082|-1.535|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.535|-2.082|<.0001
91644119|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.858|||<|0.0001|TWO_SIDED|95.0|-2.096|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.096|<.0001
91644120|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.427|||<|0.0001|TWO_SIDED|95.0|1.166|1.688|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.688|1.166|<.0001
91706358|NCT02440854|183306860|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.006
91706359|NCT02440854|183306860|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.077
91644121|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.393|||<|0.0001|TWO_SIDED|95.0|1.166|1.62|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.620|1.166|<.0001
91644122|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.541|||<|0.0001|TWO_SIDED|95.0|1.278|1.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.803|1.278|<.0001
91706360|NCT02440854|183306860|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
91706361|NCT02440854|183306860|OTHER|||||||0.508|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.508
91706362|NCT02440854|183306860|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
91706363|NCT02440854|183306860|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
91706364|NCT02440854|183306860|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
91706365|NCT02440854|183306860|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
91706366|NCT02440854|183306860|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
91706367|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||>0.999
91706368|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
91706369|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
91706370|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
91706371|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
91706372|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
91706373|NCT02440854|183306861|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
91706374|NCT02440854|183306862|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.774
91706375|NCT02440854|183306862|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
91706376|NCT02440854|183306862|OTHER|||||||0.607|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.607
91706377|NCT02440854|183306862|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.774
91706378|NCT02440854|183306862|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
91706379|NCT02440854|183306862|OTHER|||||||0.453|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.453
91706380|NCT02440854|183306862|OTHER|||||||0.688|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.688
91706381|NCT02440854|183306862|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
91706382|NCT02440854|183306862|OTHER|||||||0.25|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||0.250
91706383|NCT02440854|183306862|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
91706384|NCT02440854|183306863|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.077
91706385|NCT02440854|183306863|OTHER||||||<|0.001|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||<0.001
91706386|NCT02440854|183306863|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.006
91706387|NCT02440854|183306863|OTHER|||||||0.344|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.344
91706388|NCT02440854|183306863|OTHER|||||||0.146|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.146
91706389|NCT02440854|183306863|OTHER|||||||0.18|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.180
91706390|NCT02440854|183306863|OTHER|||||||0.289|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.289
91644123|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.243|1.695|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.695|1.243|<.0001
91644124|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.059||||0.9987|TWO_SIDED|95.0|-0.233|0.351|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.351|-0.233|0.9987
91644125|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.253|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.253|1.0000
91644126|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||0.9999|TWO_SIDED|95.0|-0.246|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.332|-0.246|0.9999
91644127|NCT03692078|183180083|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.002||||1|TWO_SIDED|95.0|-0.251|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.251|1.0000
91644128|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.407|||<|0.0001|TWO_SIDED|95.0|2.283|2.531|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.531|2.283|<.0001
91644129|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.398|||<|0.0001|TWO_SIDED|95.0|2.253|2.543|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.543|2.253|<.0001
91644130|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.303|||<|0.0001|TWO_SIDED|95.0|2.187|2.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.420|2.187|<.0001
91644131|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|2.112|2.389|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.389|2.112|<.0001
91706391|NCT02440854|183306863|OTHER|||||||0.125|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||0.125
91706392|NCT02440854|183306863|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
91518765|NCT01951625|182911715|OTHER||Log-Scale mean difference|-0.0731|||=|0.3042|TWO_SIDED|90.0|-0.31|0.16|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.16|-0.31|= 0.3042
91644132|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.285|||<|0.0001|TWO_SIDED|95.0|2.166|2.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.404|2.166|<.0001
91644133|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.272|||<|0.0001|TWO_SIDED|95.0|2.133|2.412|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.412|2.133|<.0001
91644134|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.992|||<|0.0001|TWO_SIDED|95.0|1.844|2.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.140|1.844|<.0001
91644135|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.894|||<|0.0001|TWO_SIDED|95.0|1.719|2.069|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.069|1.719|<.0001
91644136|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.102|||<|0.0001|TWO_SIDED|95.0|1.955|2.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.248|1.955|<.0001
91644137|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.075|||<|0.0001|TWO_SIDED|95.0|1.9|2.25|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.250|1.900|<.0001
91644138|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.89|||<|0.0001|TWO_SIDED|95.0|1.746|2.033|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.033|1.746|<.0001
91644139|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.944|||<|0.0001|TWO_SIDED|95.0|1.775|2.114|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.114|1.775|<.0001
91706393|NCT02440854|183306863|OTHER|||||||0.5|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||0.500
91706394|NCT02440854|183306864|OTHER|||||||0.21|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.210
91524193|NCT00532155|182923510|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard ratio|0.819||||0.0035|TWO_SIDED|95.0|0.716|0.937|||Stratified Log-Rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||0.937|0.716|0.0035
91706395|NCT02440854|183306864|OTHER|||||||0.263|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.263
91706396|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
91706397|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
91706398|NCT02440854|183306864|OTHER|||||||0.629|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.629
91706399|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
91706400|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
91706401|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
91706402|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
91706403|NCT02440854|183306864|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
91706404|NCT02440854|183306865|OTHER|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 2-month post-baseline.||||0.098
91706405|NCT02440854|183306865|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 4-month post-baseline.||||0.359
91706406|NCT02440854|183306865|OTHER|||||||0.393|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 6-month post-baseline.||||0.393
91706407|NCT02440854|183306865|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 8-month post-baseline.||||0.055
91706408|NCT02440854|183306865|OTHER|||||||0.124|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 10-month post-baseline.||||0.124
91706409|NCT02440854|183306865|OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 12-month post-baseline.||||0.376
91706410|NCT02440854|183306865|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 18-month post-baseline.||||0.033
91706411|NCT02440854|183306865|OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 24-month post-baseline.||||0.048
91706412|NCT02440854|183306865|OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 30-month post-baseline.||||0.071
91706413|NCT02440854|183306865|OTHER|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 36-month post-baseline.||||0.848
91706414|NCT02243046|183306878|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.091
91706415|NCT02243046|183306879|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91706416|NCT02243046|183306880|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
91706417|NCT02243046|183306881|SUPERIORITY_OR_OTHER|||||||0.571|||||||ANOVA|||The null hypothesis states that there is no difference between groups||||0.571
91706418|NCT02243046|183306882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
91706419|NCT02243046|183306883|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
91706420|NCT02669082|183306884|OTHER|||||||0.2955|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.2955
91706421|NCT02669082|183306885|OTHER|||||||0.1358|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1358
91706422|NCT02669082|183306886|OTHER||Median|||||0.1706|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1706
91706423|NCT02669082|183306887|OTHER|||||||0.1969|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1969
91706424|NCT02669082|183306888|OTHER|||||||0.0534|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0534
91706425|NCT02669082|183306889|OTHER|||||||0.4125|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.4125
91706426|NCT02669082|183306890|OTHER|||||||0.022|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0220
91706427|NCT02669082|183306891|OTHER|||||||0.042|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0420
91706428|NCT02669082|183306892|OTHER|||||||0.8166|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.8166
91706429|NCT02301039|183306896|SUPERIORITY|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.|Binomial estimate of response rate of PR|17.5|||||TWO_SIDED|95.0|7.3|32.8|||||Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||32.8|7.3|
91518766|NCT01951625|182911715|OTHER||Log-Scale mean difference|-0.0396|||=|0.3841|TWO_SIDED|90.0|-0.26|0.18|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.18|-0.26|= 0.3841
91644140|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.8674|TWO_SIDED|95.0|-0.345|0.137|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.137|-0.345|0.8674
91644141|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.148||||0.6519|TWO_SIDED|95.0|-0.429|0.133|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.133|-0.429|0.6519
91644142|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.122||||0.7301|TWO_SIDED|95.0|-0.363|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.119|-0.363|0.7301
91644143|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.126||||0.8076|TWO_SIDED|95.0|-0.405|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.154|-0.405|0.8076
91644144|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.415||||0.0004|TWO_SIDED|95.0|-0.689|-0.142|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.142|-0.689|0.0004
91644145|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.504||||0.0002|TWO_SIDED|95.0|-0.822|-0.185|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.185|-0.822|0.0002
91644146|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.306||||0.0183|TWO_SIDED|95.0|-0.578|-0.034|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.034|-0.578|0.0183
91644147|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.323||||0.0443|TWO_SIDED|95.0|-0.641|-0.005|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.005|-0.641|0.0443
91706430|NCT02301039|183306896|SUPERIORITY||Binomial estimate of response rate of PR|5.0|||||TWO_SIDED|95.0|1.0|16.9|||||Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||16.9|1.0|
91518767|NCT01951625|182911715|OTHER||Log-Scale mean difference|0.0151|||=|0.5444|TWO_SIDED|90.0|-0.21|0.24|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only.||0.24|-0.21|= 0.5444
91518768|NCT05338333|182911756|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction, period, sequence, and habitual lens stratum) and random (subject) effects. Difference = LID210464 minus AOHG MF.|||0.00||
91518769|NCT04951336|182911757|SUPERIORITY||ratio of frequencies|0.04||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
91644148|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.414||||0.0002|TWO_SIDED|95.0|0.155|0.672|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.672|0.155|0.0002
91644149|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.306||||0.0454|TWO_SIDED|95.0|0.004|0.608|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.608|0.004|0.0454
91644150|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.396||||0.0004|TWO_SIDED|95.0|0.136|0.655|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.655|0.136|0.0004
91644151|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.328||||0.0261|TWO_SIDED|95.0|0.026|0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.630|0.026|0.0261
91644152|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.102||||0.9455|TWO_SIDED|95.0|-0.187|0.392|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.392|-0.187|0.9455
91518770|NCT04951336|182911758|SUPERIORITY||ratio of frequencies|0.06||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
91518771|NCT04951336|182911759|SUPERIORITY||ratio of frequencies|0.7||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
91518772|NCT04951336|182911760|SUPERIORITY||ratio of frequencies|1.68||||0.359|TWO_SIDED||||||Chi-squared, Corrected|||||||0.359
91644153|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.9999|TWO_SIDED|95.0|-0.387|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.287|-0.387|0.9999
91706431|NCT02301039|183306896|SUPERIORITY||Binomial estimate of response rate of PR|13.0|||||TWO_SIDED|95.0|5.5|25.3|||||Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||25.3|5.5|
91581596|NCT02349425|183053216|SUPERIORITY||Estimated percent change|-57.067||||0.0009|TWO_SIDED|95.0|-73.375|-30.771|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.771|-73.375|0.0009
91644154|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.212||||0.2633|TWO_SIDED|95.0|-0.074|0.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.498|-0.074|0.2633
91644155|NCT03692078|183180085|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.13||||0.8769|TWO_SIDED|95.0|-0.205|0.465|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.465|-0.205|0.8769
91644156|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|5.417|||<|0.0001|TWO_SIDED|95.0|5.315|5.52|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)||5.520|5.315|<.0001
91644157|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|5.436|||<|0.0001|TWO_SIDED|95.0|5.324|5.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)||5.548|5.324|<.0001
91644158|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.957|||<|0.0001|TWO_SIDED|95.0|4.86|5.053|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)||5.053|4.860|<.0001
91710562|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.82|STANDARD_ERROR_OF_MEAN|0.83||0.0017|TWO_SIDED|90.0|1.41|4.23|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.75 hrs post-dose)||4.23|1.41|0.0017
91771764|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2024|TWO_SIDED|95.0|0.72|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.64|0.72|0.2024
91771765|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1716|TWO_SIDED|95.0|0.76|4.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.79|0.76|0.1716
91771766|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0199|TWO_SIDED|95.0|1.2|8.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.51|1.20|0.0199
91771767|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0002|TWO_SIDED|95.0|2.8|25.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.54|2.80|0.0002
91771768|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4243|TWO_SIDED|95.0|0.57|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.77|0.57|0.4243
91771769|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1507|TWO_SIDED|95.0|0.78|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.78|0.1507
91771770|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0449|TWO_SIDED|95.0|1.02|6.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.60|1.02|0.0449
91771771|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2759|TWO_SIDED|95.0|0.66|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.24|0.66|0.2759
91771772|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.9||||0.17|TWO_SIDED|95.0|0.76|4.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.78|0.76|0.1700
91771773|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0153|TWO_SIDED|95.0|1.27|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.51|1.27|0.0153
91771774|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|6.04||||0.0009|TWO_SIDED|95.0|2.08|17.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.53|2.08|0.0009
91771775|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6228|TWO_SIDED|95.0|0.5|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.23|0.50|0.6228
91771776|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.62||||0.046|TWO_SIDED|95.0|1.02|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.76|1.02|0.0460
91706432|NCT01687283|183306916|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-1.8||||0.733|TWO_SIDED|95.0|-12.19|8.59||Analysis performed using ANCOVA with covariates of baseline, center, sex, age and treatment|ANCOVA||The analysis only included participants who had at least 4 days of non-missing AM PEF data in the baseline week prior to randomization and at least 4 days of non-missing AM PEF data after randomization.|||8.59|-12.19|0.733
91706433|NCT01687283|183306917|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-2.28||||0.674|TWO_SIDED|95.0|-12.95|8.38|||ANCOVA|||||8.38|-12.95|0.674
91706434|NCT01687283|183306918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77||||0.579|TWO_SIDED|95.0|-12.57|7.04|||ANCOVA|||||7.04|-12.57|0.579
91706435|NCT01687283|183306919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.854|TWO_SIDED|95.0|-6.0|7.24|||ANCOVA|||||7.24|-6.00|0.854
91706436|NCT01687283|183306920|SUPERIORITY_OR_OTHER|||||||0.123|||||||Wilcoxon rank sum test|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median day-time symptom score||||0.123
91706437|NCT01687283|183306920|SUPERIORITY_OR_OTHER|||||||0.949|||||||Wilcoxon rank sum test.|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median night-time symptom score||||0.949
91706438|NCT01687283|183306921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.74||||0.204|TWO_SIDED|95.0|-12.07|2.59|||ANCOVA|||||2.59|-12.07|0.204
91706439|NCT01687283|183306922|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon Rank sum|||||||0.170
91771777|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1215|TWO_SIDED|95.0|0.82|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.23|0.82|0.1215
91706440|NCT01687283|183306923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039||||0.337|TWO_SIDED|95.0|-0.118|0.041||Repeated Measures analysis adjusted for baseline, centre, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 2||0.041|-0.118|0.337
91706441|NCT01687283|183306923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.008||||0.866|TWO_SIDED|95.0|-0.101|0.085||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 4||0.085|-0.101|0.866
91706442|NCT01687283|183306923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025||||0.566|TWO_SIDED|95.0|-0.113|0.062||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 8||0.062|-0.113|0.566
91706443|NCT01687283|183306923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017||||0.727|TWO_SIDED|95.0|-0.078|0.112||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 12||0.112|-0.078|0.727
91706444|NCT00497146|183306927|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Mixed Models Analysis|Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.||||||0.145
91706445|NCT04575584|183306944|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.562|TWO_SIDED|95.0|0.68|1.45|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.45|0.68|0.5620
91706446|NCT04575584|183306944|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3145|TWO_SIDED|95.0|0.78|1.65|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.65|0.78|0.3145
91706447|NCT04575584|183306944|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.4894|TWO_SIDED|95.0|0.69|1.47|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.47|0.69|0.4894
91706448|NCT04575584|183306947|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1642|TWO_SIDED|95.0|-2.3|12.1|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.1|-2.3|0.1642
91706449|NCT04575584|183306947|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.09|TWO_SIDED|95.0|-1.1|13.9|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||13.9|-1.1|0.0900
91771778|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.75||||0.247|TWO_SIDED|95.0|0.68|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.48|0.68|0.2470
91771779|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2072|TWO_SIDED|95.0|0.72|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.66|0.72|0.2072
91771780|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0621|TWO_SIDED|95.0|0.95|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.95|0.0621
91771781|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|5.67||||0.0016|TWO_SIDED|95.0|1.93|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.69|1.93|0.0016
91771782|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4372|TWO_SIDED|95.0|0.56|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.84|0.56|0.4372
91771783|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.18||||0.11|TWO_SIDED|95.0|0.84|5.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.66|0.84|0.1100
91706450|NCT04575584|183306947|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.1594|TWO_SIDED|95.0|-2.3|12.3|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.3|-2.3|0.1594
91706451|NCT04575584|183306948|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3623|TWO_SIDED|95.0|0.73|2.35|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. Confidence intervals (CIs) are based on Wald Chi-Square Test.|||2.35|0.73|0.3623
91706452|NCT04575584|183306948|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
91706453|NCT04575584|183306948|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
91706454|NCT04575584|183306949|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4398|TWO_SIDED|95.0|0.7|2.3|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.30|0.70|0.4398
91706455|NCT04575584|183306949|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
91706456|NCT04575584|183306949|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
91706457|NCT04575584|183306950|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2422|TWO_SIDED|95.0|0.77|2.85|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.85|0.77|0.2422
91706458|NCT04575584|183306950|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
91706459|NCT04575584|183306950|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6052|TWO_SIDED|95.0|0.45|1.59|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.59|0.45|0.6052
91706460|NCT04575584|183306951|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
91706461|NCT04575584|183306951|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
91706462|NCT04575584|183306951|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
91706463|NCT04575584|183306952|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9945|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9945
91706464|NCT04575584|183306952|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
91706465|NCT04575584|183306952|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
91706466|NCT04575584|183306953|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4472|TWO_SIDED|95.0|0.7|2.25|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.25|0.70|0.4472
91706467|NCT04575584|183306953|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
91706468|NCT04575584|183306953|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
91706469|NCT04575584|183306954|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5222|TWO_SIDED|95.0|0.67|2.21|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.21|0.67|0.5222
91706470|NCT04575584|183306954|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
91706471|NCT04575584|183306954|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
91706472|NCT04575584|183306955|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2627|TWO_SIDED|95.0|0.75|2.8|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.80|0.75|0.2627
91706473|NCT04575584|183306955|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
91706474|NCT04575584|183306955|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5938|TWO_SIDED|95.0|0.45|1.58|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.58|0.45|0.5938
91706475|NCT04575584|183306956|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
91706476|NCT04575584|183306956|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
91706477|NCT04575584|183306956|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
91706478|NCT04575584|183306957|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9445|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9445
91706479|NCT04575584|183306957|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
91706480|NCT04575584|183306957|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
91706481|NCT04575584|183306958|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8732|TWO_SIDED|95.0|0.46|2.47|||Wald Chi-Square||Proportional odds model with National Early Warning Score (NEWS) categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.47|0.46|0.8732
91706482|NCT04575584|183306958|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1277|TWO_SIDED|95.0|0.25|1.19|||Wald Chi-square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.19|0.25|0.1277
91706483|NCT04575584|183306958|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4326|TWO_SIDED|95.0|0.33|1.61|||Wald Chi-Square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.33|0.4326
91706484|NCT04575584|183306959|SUPERIORITY||Odds Ratio (OR)|1.2||||0.683|TWO_SIDED|95.0|0.5|2.88|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.50|0.6830
91706485|NCT04575584|183306959|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.42|2.39|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.39|0.42|1.000
91706486|NCT04575584|183306959|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8244|TWO_SIDED|95.0|0.37|2.2|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.20|0.37|0.8244
91706487|NCT04575584|183306960|SUPERIORITY||Odds Ratio (OR)|0.77||||0.5022|TWO_SIDED|95.0|0.36|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.36|0.5022
91706488|NCT04575584|183306960|SUPERIORITY||Odds Ratio (OR)|0.78||||0.5204|TWO_SIDED|95.0|0.37|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.37|0.5204
91706489|NCT04575584|183306960|SUPERIORITY||Odds Ratio (OR)|0.52||||0.0991|TWO_SIDED|95.0|0.24|1.13|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.13|0.24|0.0991
91706490|NCT04575584|183306961|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6346|TWO_SIDED|95.0|0.6|2.29|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.29|0.60|0.6346
91706491|NCT04575584|183306961|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7596|TWO_SIDED|95.0|0.46|1.75|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.46|0.7596
91706492|NCT04575584|183306961|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8879|TWO_SIDED|95.0|0.49|1.84|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.84|0.49|0.8879
91706493|NCT04575584|183306962|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6002|TWO_SIDED|95.0|0.55|2.82|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.82|0.55|0.6002
91706494|NCT04575584|183306962|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4733|TWO_SIDED|95.0|0.58|3.21|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.21|0.58|0.4733
91706495|NCT04575584|183306962|SUPERIORITY||Odds Ratio (OR)|0.82||||0.622|TWO_SIDED|95.0|0.38|1.78|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.78|0.38|0.6220
91706496|NCT04575584|183306963|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7871|TWO_SIDED|95.0|0.28|2.6|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.60|0.28|0.7871
91706497|NCT04575584|183306963|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9598|TWO_SIDED|95.0|0.31|3.06|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.06|0.31|0.9598
91706498|NCT04575584|183306963|SUPERIORITY||Odds Ratio (OR)|0.79||||0.667|TWO_SIDED|95.0|0.27|2.31|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.31|0.27|0.6670
91706499|NCT02634801|183306964|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.08|||<|0.0001|TWO_SIDED|95.0|2.46|6.77|||Fisher Exact|||||6.77|2.46|<.0001
91706500|NCT02634801|183306964|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.29||||0.0137|TWO_SIDED|95.0|1.06|1.56|||Fisher Exact|||||1.56|1.06|0.0137
91706501|NCT02178358|183307019|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.837|TWO_SIDED|95.0|0.434|1.226|||Bayesian exponential-likelihood model|||||1.226|0.434|0.837
91706502|NCT02178358|183307019|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.704|TWO_SIDED|95.0|0.633|1.266|||Bayesian exponential-likelihood model|||||1.266|0.633|0.704
91706503|NCT05600036|183307039|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
91706504|NCT05600036|183307039|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
91706505|NCT05600036|183307039|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91706506|NCT05600036|183307039|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91706507|NCT05600036|183307039|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91706508|NCT04348500|183307043|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Chi-squared|||The null hypothesis is that there is no difference in the use of clazakizumab as a treatment compared to placebo in reducing or eliminating the incidence of severe adverse events among patients with COVID-19.||||0.10
91706509|NCT04348500|183307049|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Fisher Exact|||Null hypothesis is that there is no change in the need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo.||||0.10
91706510|NCT02722746|183307050|SUPERIORITY||percent difference|20.8||||0.165|TWO_SIDED|95.0|-8.9|47.3|||Z-test for proportions|||||47.3|-8.9|0.165
91706511|NCT02722746|183307050|SUPERIORITY||percent difference|14.4||||0.353|TWO_SIDED|95.0|-15.9|42.2|||Z-test for proportions|||||42.2|-15.9|0.353
91706512|NCT02722746|183307051|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||For PACU spread||||0.06
91706513|NCT02722746|183307051|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||For Pre-op spread||||0.22
91706514|NCT02722746|183307051|SUPERIORITY|||||||0.74|||||||Kruskal-Wallis|||For POD 1||||0.74
91706515|NCT02722746|183307052|SUPERIORITY|||||||0.551|||||||ANOVA|||||||0.551
91706516|NCT02722746|183307053|SUPERIORITY|||||||0.349|||||||Mixed Models Analysis|||||||0.349
91706517|NCT02722746|183307054|SUPERIORITY|||||||0.18|||||||Fisher Exact|||For Pruritis||||0.18
91706518|NCT02722746|183307054|SUPERIORITY|||||||0.44|||||||Fisher Exact|||For Nausea/Vomiting||||0.44
91706519|NCT02722746|183307054|SUPERIORITY|||||||0.74|||||||Fisher Exact|||For Respirartory Depression||||0.74
91706520|NCT02722746|183307058|SUPERIORITY|||||||0.524|||||||ANOVA|||For SBP||||0.524
91706521|NCT02722746|183307058|SUPERIORITY|||||||0.585|||||||ANOVA|||For DBP||||0.585
91706522|NCT02722746|183307058|SUPERIORITY|||||||0.199|||||||ANOVA|||For MAP||||0.199
91706523|NCT02722746|183307059|SUPERIORITY|||||||0.231|||||||Mixed Models Analysis|||||||0.231
91706524|NCT02722746|183307060|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
91706525|NCT02722746|183307061|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
91706526|NCT02722746|183307062|SUPERIORITY|||||||0.567|||||||ANOVA|||||||0.567
91706527|NCT00703118|183307088|SUPERIORITY_OR_OTHER||Difference in percentage of response|46.8|||<|0.001|TWO_SIDED|95.0|36.8|56.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||56.7|36.8|<0.001
91706528|NCT00703118|183307088|SUPERIORITY_OR_OTHER||Difference in percentage of response|49.8|||<|0.001|TWO_SIDED|95.0|39.9|59.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||59.7|39.9|<0.001
91706529|NCT02005627|183307122|SUPERIORITY||||||<|0.05||||||calculated|t-test, 2 sided|||||||<0.05
91706530|NCT02005627|183307125|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91706531|NCT02005627|183307126|SUPERIORITY|||||||||||||||||Null Hypothesis was no difference between Grazax and Placebo treatment at 12 months. 80% power to detect 30% difference in total nasal symptom score (TNSS) after nasal challenge|Comparison of nasal symptom score at 0-60 mins after nasal challenge after 12 months treatment with Grazax compared to Placebo treatment. Mixed model analysis. 80% power to detect a 30% difference at p\<0.05.|||
91706532|NCT04000360|183307127|SUPERIORITY||Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.85||This was the sole primary outcome. The test was conducted with a priori p-value threshold of α=0.05, with no multiple comparison adjustment.|Mixed Models Analysis|Test of equality of slopes with time (change in points/year) between aerobic exercise (AE) and usual and customary care (UCC) treatment arms.|Higher MDS-UPDRS III score reflects worse Parkinson's symptoms; increases reflect PD progression. The reported effect is the estimated difference between annual rates of change in scores of AE and UCC patients.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and AR(1) covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||-1.85|-5.40|<0.0001
91706533|NCT04000360|183307128|SUPERIORITY|Equality of annual slopes in squared 10 Meter Walk Test Comfortable Pace Velocity for the AE and UCC groups.|Difference in squared velocity slopes|12.07|STANDARD_ERROR_OF_MEAN|4.65||0.043|TWO_SIDED|95.0|3.1|21.32||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 Meter Walk Test fast pace velocity, TUG duration \& turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slope of meters\^2/second, in 100ths of meters\^2/second/year. The confidence interval is not multiple comparison adjusted. Parkinson's progression limits mobility; higher slope reflects less progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test velocity was squared ((meters/second)\^2) for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||21.32|3.10|0.043
91706534|NCT04000360|183307129|SUPERIORITY|Equality of annual slopes in 10 Meter Walk Test Fast Pace Velocity for the AE and UCC groups.|Difference in slopes|3.16|STANDARD_ERROR_OF_MEAN|2.68||0.48|TWO_SIDED|95.0|-2.1|8.42||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable pace, Timed Up and Go Test duration and turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slopes of the AE and UCC treatment arms, in 100ths of meters/second/year. The confidence interval is not multiple comparison adjusted. Higher slope reflects less Parkinson's disease progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||8.42|-2.10|0.48
91706535|NCT04000360|183307130|SUPERIORITY|Equality of annual slopes of inverse Timed Up and Go Test duration, i.e., of TUG completions/second, the speed of completing the test.|Difference in slopes|4.04|STANDARD_ERROR_OF_MEAN|1.96||0.16|TWO_SIDED|95.0|0.2|7.89||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test turning velocity, and Manual Dexterity Test.|Mixed Models Analysis|Difference between estimated annual slopes in TUG completions/second/year for the AE and UCC groups.|Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a TUG completion/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was inverted to TUG completions/second. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||7.89|0.20|0.16
91710563|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|90.0|2.51|5.09|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.25 hrs post-dose)||5.09|2.51|<0.0001
91706536|NCT04000360|183307131|SUPERIORITY|Test of equality of average turning velocities.|Difference in slopes.|1.85|STANDARD_ERROR_OF_MEAN|1.54||0.69|TWO_SIDED|95.0|-1.17|4.88||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test duration, and Manual Dexterity Test.|Mixed Models Analysis||Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes of average turning velocity for the AE and UCC groups in degrees/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||4.88|-1.17|0.69
91706537|NCT04000360|183307132|SUPERIORITY|Test of equality of slopes of test performance speed (peg transfers/second/year) for AE and UCC groups.|Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|10.23||0.72|TWO_SIDED|95.0|-23.68|16.45||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: Timed Up and Go Test (TUG) duration \& turning velocity and 10 meter walk test comfortable \& fast pace.|Mixed Models Analysis||Manual dexterity expressed as peg transfers/second is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a peg transfer/second/year.|Linear mixed model for baseline, 6 and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was transformed for modeling to peg transfers/second (18/seconds). Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||16.45|-23.68|0.72
91706538|NCT04000360|183307133|SUPERIORITY|Test of equality of slopes of squared match scores (matches\^2/year) between AE and UCC groups.|Difference in slopes.|-96.91|STANDARD_ERROR_OF_MEAN|69.12||0.48|TWO_SIDED|95.0|-232.41|38.6||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Visual Memory Test and Trail Making Test B to A duration ratio.|Mixed Models Analysis||Processing speed is expected to decline with Parkinson's, hence duration of the test to increase. The reported effect is the difference in annual slopes (matches\^2/year) between the AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was squared (matches\^2) for analysis. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||38.60|-232.41|0.48
91706539|NCT04000360|183307134|SUPERIORITY|Test of equality of annual slopes of log(TMT B to TMT A duration ratio) for AE and UCC groups.|Difference in slopes|-3.42|STANDARD_ERROR_OF_MEAN|6.06||1|TWO_SIDED|95.0|-15.31|8.46||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Visual Memory Test.|Mixed Models Analysis||Visual attention and set switching speed decline with Parkinson's, hence duration of Trail Making Test B increases. The reported effect is the difference in annual slopes of (log TMT B/TMT A), i.e., change/year, between AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the ratios were transformed to their natural logarithms for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||8.46|-15.31|1.00
91706540|NCT04000360|183307135|SUPERIORITY|Test of equality of annual slopes of squared test score.|Difference in slopes|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|-2.58|2.91||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Trail Making Test Ratio.|Mixed Models Analysis||Visual memory declines with Parkinson's, hence the score declines. The reported effect is the difference in annual slopes, i.e., changes in mean score\^2/year, for AE and UCC treatment arms, shown in hundreds. Higher slope indicates slower decline.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the score was squared for statistical modeling. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||2.91|-2.58|0.91
91706541|NCT04006509|183307191|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
91706542|NCT04006509|183307192|SUPERIORITY|||||||0.539|||||||Marginal Two-Part Model|||||||0.539
91706543|NCT04006509|183307193|SUPERIORITY|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
91706544|NCT04006509|183307194|SUPERIORITY|||||||0.743|||||||Marginal Two-Part Model|||||||0.743
91706545|NCT04006509|183307195|SUPERIORITY|||||||0.886|||||||Marginalized Two-Part Model|||||||0.886
91706546|NCT04006509|183307196|SUPERIORITY|||||||0.107|||||||Marginalized Two-Part Model|||||||0.107
91706547|NCT04006509|183307197|SUPERIORITY|||||||0.687|||||||Marginalized Two-Part Model|||||||0.687
91706548|NCT04006509|183307198|SUPERIORITY|||||||0.871|||||||Marginalized Two-Part Model|||||||0.871
91706549|NCT04006509|183307199|SUPERIORITY|||||||0.376|||||||Marginalized Two-Part Model|||||||0.376
91706550|NCT04006509|183307200|SUPERIORITY|||||||0.77|||||||Marginalized Two-Part Model|||||||0.770
91706551|NCT04006509|183307201|SUPERIORITY|||||||0.237|||||||Marginalized Two-Part Model|||||||0.237
91706552|NCT00048997|183307208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.2853|TWO_SIDED|95.0|0.84|1.38||One-sided significance level of 0.025.|Log Rank||Prophylactic cranial irradiation (PCI) is the reference arm for the hazard ratio.|This study was designed to detect a 20% relative improvement in hazard rate: null hypothesis (observation): MST (median survival time) = 23.5 mo.; alternative hypothesis (PCI): MST= 29.4 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 1007 patients (527 deaths were required for the final analysis).||1.38|0.84|0.2853
91706553|NCT00048997|183307209|SUPERIORITY|||||||0.01|||||||Z-test, 2-sided|2-sided significance level = 0.05||||||0.01
91706554|NCT00048997|183307210|SUPERIORITY|||||||0.008|||||||Z-test, 2-sided|Significance level = 0.05||||||0.008
91706555|NCT00048997|183307211|SUPERIORITY|||||||0.2|||||||Z-test, 2-sided|Significance level = 0.05||||||0.20
91706556|NCT00048997|183307212|SUPERIORITY|||||||0.14|||||||Z-test, 2-sided|Significance level = 0.05||||||0.14
91706557|NCT00048997|183307213|SUPERIORITY|||||||0.52|||||||Z-test, 2-sided|Significance level = 0.05||||||0.52
91706558|NCT00048997|183307214|SUPERIORITY|||||||0.51|||||||Z-test, 2-sided|Significance level = 0.05||||||0.51
91706559|NCT00048997|183307215|SUPERIORITY|||||||0.11|||||||Other [Z-test, 2-sided]|Significance level = 0.05||||||0.11
91706560|NCT00048997|183307216|SUPERIORITY||Odds Ratio (OR)|2.52||||0.005|TWO_SIDED|95.0|1.32|4.8|||Regression, Logistic|2-sided significance level = 0.05|Reference level = PCI arm|The development of CNS metastases was assessed using logistic regression modeling comparing presence vs. absence of brain metastases at 1 year.||4.80|1.32|0.005
91706561|NCT00002525|183307225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178||||||one-sided log-rank test p value|Log Rank|||||||0.178
91706562|NCT00002525|183307226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.847||||||two-sided log rank test|Log Rank|||||||0.847
91706563|NCT03304184|183307229|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine)|Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0001
91706564|NCT03304184|183307229|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine) over timepoints|Mean Difference (Final Values)|3.0||||0.0005|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0005
91706565|NCT03304184|183307230|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine).|Mean Difference (Final Values)|3.0||||0.091|TWO_SIDED|95.0||||Comparison between two groups for treatment|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0910
91706566|NCT03304184|183307230|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points|Mean Difference (Final Values)|3.0||||0.0262|TWO_SIDED|95.0||||Comparison between the two arms for treatment time points with analysis|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0262
91706567|NCT03304184|183307231|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in brief pain inventory scores between the two treatment groups (Photac and Biodentine) over different time points.|Mean Difference (Final Values)|3.0||||0.0289|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0289
91706568|NCT01505179|183307232|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
91706569|NCT01505179|183307233|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91706570|NCT01505179|183307234|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
91706571|NCT01505179|183307235|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
91706572|NCT02051335|183307253|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.556||0.573|TWO_SIDED|95.0|-1.4|0.8||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.8|-1.4|0.573
91706573|NCT02051335|183307253|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.55||0.21|TWO_SIDED|95.0|-1.8|0.4||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.4|-1.8|0.210
91706574|NCT02051335|183307253|SUPERIORITY_OR_OTHER||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.547||0.821|TWO_SIDED|95.0|-1.0|1.2||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.2|-1.0|0.821
91706575|NCT02051335|183307253|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.549||0.426|TWO_SIDED|95.0|-0.7|1.5||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.5|-0.7|0.426
91706576|NCT02051335|183307253|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.53||0.126|TWO_SIDED|95.0|-0.2|1.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.9|-0.2|0.126
91706577|NCT02051335|183307254|SUPERIORITY_OR_OTHER||LS mean difference|1.93|STANDARD_ERROR_OF_MEAN|0.992||0.057|TWO_SIDED|95.0|-0.1|3.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||3.9|-0.1|0.057
91706578|NCT02051335|183307254|SUPERIORITY_OR_OTHER||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.981||0.394|TWO_SIDED|95.0|-2.8|1.1||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.1|-2.8|0.394
91706579|NCT02051335|183307254|SUPERIORITY_OR_OTHER||LS mean difference|2.01|STANDARD_ERROR_OF_MEAN|0.972||0.042|TWO_SIDED|95.0|0.1|4.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.0|0.1|0.042
91706580|NCT02051335|183307254|SUPERIORITY_OR_OTHER||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.974||0.928|TWO_SIDED|95.0|-1.9|2.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||2.0|-1.9|0.928
91706581|NCT02051335|183307254|SUPERIORITY_OR_OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.943||0.004|TWO_SIDED|95.0|1.0|4.7||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.7|1.0|0.004
91706582|NCT01490697|183307275|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-18.0|16.0|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||16|-18|
91706583|NCT01490697|183307276|SUPERIORITY||Mean Difference (Net)|3.9|||||TWO_SIDED|95.0|-6.9|14.7|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||14.7|-6.9|
91706584|NCT00090584|183307277|SUPERIORITY_OR_OTHER||Difference in cumulative success rates|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.74|TWO_SIDED|95.0|-0.12|0.12|||Log Rank|||Kaplan Meier Lifetable analysis was used to compute the 8 month cumulative success rates.||0.12|-0.12|0.74
91706585|NCT00090584|183307278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|2.0||0.34|TWO_SIDED|95.0|-2.0|5.9||Mixed effect repeated measures analysis of variance controlling for study site.|ANOVA|||Test of hypothesis of no difference in change in episodes between the two groups.||5.9|-2.0|0.34
91706586|NCT00090584|183307279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.7|0.1||Repeated measures ANOVA controlling for clinical site.|ANOVA||Difference (group 1 - group 2) in change from baseline to follow-up in voids per day.|Null hypothesis of no difference between arms in change in number of voids per day from baseline to 10 weeks.||0.1|-1.7|0.08
91706587|NCT00090584|183307280|SUPERIORITY_OR_OTHER||Other|0.0||||0.0006||95.0||||Repeated measures ANOVA|Mixed Models Analysis|Main hypothesis tested by F-test for treatment by time interaction (2 and 509 degrees of freedom). No parameters estimated.||Null hypothesis is that there is no difference between treatment groups in improvement in UDI over time||||0.0006
91706588|NCT00090584|183307281|SUPERIORITY_OR_OTHER||Other|0.0||||0.0005||95.0||||P-value for test of time by treatment group interaction.|Mixed Models Analysis|Adjusted for study site||Repeated measures analysis of difference in symptom bother over time by treatment group.||||0.0005
91706589|NCT00090584|183307282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.02|TWO_SIDED|95.0|1.09|2.92|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in Combination therapy arm to Drug only arm.|Null hypothesis: no difference in satisfaction at 10 weeks||2.92|1.09|0.02
91706590|NCT00090584|183307283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.02|TWO_SIDED|95.0|1.11|3.7|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in combination therapy group compared to drug only group.|Null hypothesis: No difference in satisfaction at 8 months post intervention||3.70|1.11|0.02
91706591|NCT00090584|183307284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55||||0.008|TWO_SIDED|95.0|1.27|5.13||P-value from logistic regression analysis|Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement between women in combination therapy group compared to those in drug only group||5.13|1.27|0.008
91706592|NCT00090584|183307285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|1.83|5.52|||Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement at 8 months between women in combination therapy group compared to those in drug only group.||5.52|1.83|<0.0001
91706593|NCT00379808|183307286|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.22|||||||Wilcoxon sign rank test|||Statistical power was calculated using G\*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.||||0.22
91706594|NCT00379808|183307287|SUPERIORITY_OR_OTHER||percent difference|3.8||||0.57|||||||Wilcoxon sign rank|||Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint||||0.57
91706595|NCT00379808|183307288|SUPERIORITY_OR_OTHER||percent difference|7.4||||0.33|||||||wilcoxon sign rank|||The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.||||0.33
91706596|NCT00379808|183307289|SUPERIORITY_OR_OTHER||percent difference|11.9||||0.12|||||||Wilcoxon|||null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.||||0.12
91706597|NCT00379808|183307290|SUPERIORITY_OR_OTHER||percent difference|13.3||||0.03|||||||wilcoxon sign rank test|||null hypothesis is that montelukast does not affect IL1ra.||||0.03
91706598|NCT00379808|183307291|SUPERIORITY_OR_OTHER||percent difference|16.5||||0.09|||||||wilcoxon sign rank|||null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker||||0.09
91706599|NCT01578499|183307292|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|42.2|||<|0.001|TWO_SIDED|95.0|27.5|56.8||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.||56.8|27.5|<0.001
91706600|NCT01578499|183307293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.6||||0.0002|TWO_SIDED|95.0|-2.5|33.0||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||||33.0|-2.5|0.0002
91706601|NCT01578499|183307294|OTHER||Hazard Ratio (HR)|0.378|||<|0.001|TWO_SIDED|95.0|0.247|0.577|||Log Rank||||Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.|0.577|0.247|<0.001
91706602|NCT01578499|183307295|SUPERIORITY_OR_OTHER_LEGACY||Estimate of difference|-19.0|||<|0.001|TWO_SIDED|95.0|-26.7|-11.4|||ANCOVA|||P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.||-11.4|-26.7|<0.001
91706603|NCT00862459|183307339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|1.49||0.003|||||||t-test, 2 sided|||2 sample t-test between the dose groups||||0.003
91706604|NCT00862459|183307339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|1.59||0.844|||||||t-test, 2 sided|||||||0.844
91706605|NCT00862459|183307340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_DEVIATION|2.92||||95.0|-0.825|0.69|||confidence interval using t-distribution|||||0.69|-0.825|
91706606|NCT00862459|183307340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|3.18||||95.0|-0.9|0.79|||confidence interval using t-distribution|||||0.79|-0.90|
91706607|NCT00862459|183307341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.42||||95.0|-1.17|-0.42|||confidence interval using t-distribution|||||-0.42|-1.17|
91706608|NCT00862459|183307341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|1.57||||95.0|-0.44|0.41|||confidence interval using t-distribution|||||0.41|-0.44|
91706609|NCT00862459|183307342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.86||||95.0|-0.619|-0.17|||confidence interval using t-distribution|||||-0.17|-0.619|
91706610|NCT00862459|183307342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|1.01||||95.0|-0.25|0.22|||confidence interval using t-distribution|||||0.22|-0.25|
91706611|NCT00862459|183307343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|0.76||||95.0|-0.58|-0.18|||confidence interval using t-distribution|||||-0.18|-0.58|
91706612|NCT00862459|183307343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.76||||95.0|-0.1|0.31|||confidence interval using t-distribution|||||0.31|-0.10|
91706613|NCT00862459|183307344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.54|STANDARD_DEVIATION|76.45||||95.0|-37.11|2.02|||confidence interval using t-distribution|||difference in CNR between doses and confidence interval||2.02|-37.11|
91706614|NCT00862459|183307344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74|STANDARD_DEVIATION|77.11||||95.0|-15.86|25.35|||confidence interval using t-distribution|||||25.35|-15.86|
91706615|NCT00862459|183307345|SUPERIORITY_OR_OTHER||accuracy difference|1.66|STANDARD_ERROR_OF_MEAN|6.29||0.8||95.0|-10.93|14.24|||Chi-squared|Adjusted for clustering||||14.24|-10.93|0.80
91706616|NCT00862459|183307345|SUPERIORITY_OR_OTHER||difference in accuracies|-10.75|STANDARD_ERROR_OF_MEAN|6.83||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
91581597|NCT02349425|183053217|SUPERIORITY||Estimated percent change|-14.691||||0.2542|TWO_SIDED|95.0|-35.307|12.493|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.493|-35.307|0.2542
91706617|NCT00862459|183307346|SUPERIORITY_OR_OTHER||difference in accuracy|13.43||||0.03||95.0|1.53|25.33|||Chi-squared|adjusted for clustering||||25.33|1.53|0.03
91706618|NCT00862459|183307346|SUPERIORITY_OR_OTHER||difference in accuracies|-13.58||||0.02||95.0|-25.07|-2.09|||Chi-squared|adjusted for clustering||||-2.09|-25.07|0.02
91706619|NCT00862459|183307347|SUPERIORITY_OR_OTHER||difference in accuracy|-6.13||||0.11||95.0|-13.73|1.48|||Chi-squared|adjusted for clustering||||1.48|-13.73|0.11
91706620|NCT00862459|183307347|SUPERIORITY_OR_OTHER||difference in accuracies|2.87||||0.55||95.0|-6.59|12.32|||Chi-squared|adjusted for clustering||||12.32|-6.59|0.55
91706621|NCT00862459|183307348|SUPERIORITY_OR_OTHER||difference in accuracy|24.63||||0.02||95.0|5.39|43.86|||Chi-squared|adjusted for clustering||||43.86|5.39|0.02
91706622|NCT00862459|183307348|SUPERIORITY_OR_OTHER||difference in accuracy|-10.75||||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
91706623|NCT00862459|183307349|SUPERIORITY_OR_OTHER||difference in accuracy|12.91||||0.07||95.0|-1.44|27.26|||Chi-squared|adjusted for clustering||||27.26|-1.44|0.07
91706624|NCT00862459|183307349|SUPERIORITY_OR_OTHER||difference in accuracy|-18.37||||0.02||95.0|-33.6|-1.35|||Chi-squared|adjusted for clustering||||-1.35|-33.60|0.02
91706625|NCT00862459|183307350|SUPERIORITY_OR_OTHER||difference in accuracy|18.46||||0.02||95.0|3.15|33.77|||Chi-squared|adjusted for clustering||||33.77|3.15|0.02
91706626|NCT00862459|183307350|SUPERIORITY_OR_OTHER||difference in accuracy|-5.29||||0.45||95.0|-18.83|8.24|||Chi-squared|adjusted for clustering||||8.24|-18.83|0.45
91706627|NCT03168919|183307418|OTHER|Comparison||||||||||||||||The baseline and the end of therapy MRI parameters are compared.|Due to very small accrual, the statistical analysis couln't be performed.|||
91706628|NCT01085136|183307423|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.003|TWO_SIDED|95.0|0.44|0.85||P-value is calculated from two-sided stratified log-rank test|stratified log-rank test|||Hazard ratio is calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||0.85|0.44|0.0030
91706629|NCT01085136|183307425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7905|TWO_SIDED|95.0|0.76|1.44|||Stratified log-rank test.|P-value is calculated from two-sided stratified log-rank test.||Hazard ratio was calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||1.44|0.76|0.7905
91706630|NCT01085136|183307427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98||||0.0065|TWO_SIDED|95.0|1.357|6.543|||Regression, Logistic|||Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified for maximum treatment duration of prior erlotinib or gefitinib (\>=6 months vs \<6 months) and gender.||6.543|1.357|0.0065
91706631|NCT02993354|183307494|SUPERIORITY||Relative Rate|0.95||||0.75|TWO_SIDED|95.0|0.69|1.31|||t-test, 2 sided|||||1.31|0.69|0.75
91706632|NCT04459598|183307503|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|55.24|||||TWO_SIDED|90.0|45.24|67.46|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||67.46|45.24|
91706633|NCT04459598|183307503|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|32.37|||||TWO_SIDED|90.0|23.79|44.05|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||44.05|23.79|
91706634|NCT04459598|183307505|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|11.11|||||TWO_SIDED|90.0|8.47|14.56|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||14.56|8.47|
91706635|NCT04459598|183307505|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.67|||||TWO_SIDED|90.0|2.47|5.45|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.45|2.47|
91706636|NCT04459598|183307506|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|10.29|||||TWO_SIDED|90.0|7.73|13.7|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||13.70|7.73|
91706637|NCT04459598|183307506|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.88|||||TWO_SIDED|90.0|2.62|5.76|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.76|2.62|
91706638|NCT00410072|183307529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0882|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|||Week 96||14.9|-1.0|0.0882
91706639|NCT00410072|183307530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|||||TWO_SIDED|95.0|2.3|24.8|||NC=F|||||24.8|2.3|
91706640|NCT00410072|183307530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-7.7|12.0|||NC=F|||||12.0|-7.7|
91706641|NCT00410072|183307530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6||||0.046|TWO_SIDED|95.0|0.2|21.0|||Cochran-Mantel-Haenszel|||||21.0|0.2|0.0460
91706642|NCT00410072|183307530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-12.0|9.5|||NC=F|||||9.5|-12.0|
91706643|NCT00410072|183307531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.8|16.0|||NC=F|||Analysis at week 48. The stratified analysis was based on HBeAg strata at randomization.||16.0|-1.8|
91706644|NCT00410072|183307531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.1|15.2|||NC=F|||Analysis at week 96. The stratified analysis was based on HBeAg strata at randomization.||15.2|-1.1|
91518773|NCT04951336|182911761|SUPERIORITY|age was included as a covariate||||||0.002||||||Differences were considered statistically significant for p-values \<0.05.|Mixed Models Analysis|F(2,150)=6.374. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
91706645|NCT00410072|183307532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.5|17.1|||NC=F|||Analysis at Week 48. The stratified analysis was based on HBeAg strata at randomization.||17.1|-1.5|
91706646|NCT00410072|183307532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|||||TWO_SIDED|95.0|-0.2|17.3|||NC=F|||Analysis at Week 96. The stratified analysis was based on HBeAg strata at randomization.||17.3|-0.2|
91706647|NCT00410072|183307534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||||TWO_SIDED|95.0|-18.8|-2.0|||NC+F|||Analysis at Week 48. The stratified analysis is based on HBeAg strata at randomization.||-2.0|-18.8|
91706648|NCT00410072|183307534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-21.5|-4.1|||NC=F|||Analysis at Week 96. The stratified analysis is based on HBeAg strata at randomization.||-4.1|-21.5|
91706649|NCT00410072|183307535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||||TWO_SIDED|95.0|-15.9|4.2|||NC=F|||Analysis at Week 48||4.2|-15.9|
91706650|NCT00410072|183307535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.6|2.3|||NC=F|||Analysis at Week 96||2.3|-20.6|
91706651|NCT00410072|183307536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|||||TWO_SIDED|95.0|-13.8|5.6|||NC=F|||Analysis at Week 48||5.6|-13.8|
91706652|NCT00410072|183307536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-21.5|-0.1|||NC=F|||Analysis at Week 96||-0.1|-21.5|
91706653|NCT00410072|183307537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0|-5.3|1.9|||NC=F|||Analysis at Week 48||1.9|-5.3|
91706654|NCT00410072|183307537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-3.9|6.1|||NC=F|||Analysis at Week 96||6.1|-3.9|
91706655|NCT00410072|183307538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.0|||NC=F|||Analysis at Week 48||2.0|-2.2|
91706656|NCT00410072|183307538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||NC=F|||Analysis at Week 96||4.9|-2.3|
91706657|NCT01421147|183307545|SUPERIORITY_OR_OTHER||LS Mean Difference|0.108||||0.055|TWO_SIDED|95.0|-0.002|0.219|||ANCOVA|||||0.219|-0.002|0.055
91706658|NCT01421147|183307546|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.205|TWO_SIDED|95.0|-0.23|1.05||P-value is for change at 6 weeks.|ANCOVA|||||1.05|-0.23|0.205
91706659|NCT01421147|183307546|SUPERIORITY_OR_OTHER||LS Mean difference|0.4||||0.32|TWO_SIDED|95.0|-0.4|1.21||P-value is for change at 12 weeks.|ANCOVA|||||1.21|-0.40|0.320
91706660|NCT01421147|183307546|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.373|TWO_SIDED|95.0|-0.46|1.21||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||1.21|-0.46|0.373
91706661|NCT01421147|183307546|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.131|TWO_SIDED|95.0|-0.25|1.86||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||1.86|-0.25|0.131
91706662|NCT01421147|183307547|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.007||||0.86|TWO_SIDED|95.0|-0.087|0.072||P-value is for change at 6 weeks.|ANCOVA|||||0.072|-0.087|0.860
91706663|NCT01421147|183307547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.113||||0.03|TWO_SIDED|95.0|0.011|0.215||P-value is for change at 12 weeks.|ANCOVA|||||0.215|0.011|0.030
91706664|NCT01421147|183307547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.08|TWO_SIDED|95.0|-0.012|0.208||P-value is for change at 24 weeks.|ANCOVA|||||0.208|-0.012|0.080
91706665|NCT01421147|183307547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.314|TWO_SIDED|95.0|-0.057|0.177||P-value is for change at 36 weeks.|ANCOVA|||||0.177|-0.057|0.314
91706666|NCT01421147|183307547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.004||||0.948|TWO_SIDED|95.0|-0.119|0.127||P-value is for change at 52 weeks.|ANCOVA|||||0.127|-0.119|0.948
91706667|NCT01421147|183307547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.737|TWO_SIDED|95.0|-0.099|0.14||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.140|-0.099|0.737
91706668|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.489|TWO_SIDED|95.0|-0.33|0.69||P-value is for Baseline-AM Pre-Meal.|ANCOVA|||||0.69|-0.33|0.489
91706669|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.066|TWO_SIDED|95.0|-1.0|0.03||P-value is for Baseline-AM 2 hrs PP.|ANCOVA|||||0.03|-1.00|0.066
91706670|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28||||0.209|TWO_SIDED|95.0|-0.71|0.16||P-value is for Baseline-MD Pre-Meal.|ANCOVA|||||0.16|-0.71|0.209
91706671|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.232|TWO_SIDED|95.0|-0.2|0.82||P-value is for Baseline-MD 2 hrs PP.|ANCOVA|||||0.82|-0.20|0.232
91706672|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.856|TWO_SIDED|95.0|-0.49|0.58||P-value is for Baseline-EV Pre-Meal.|ANCOVA|||||0.58|-0.49|0.856
91706673|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.693|TWO_SIDED|95.0|-0.66|0.44||P-value is for Baseline-Bed Time.|ANCOVA|||||0.44|-0.66|0.693
91706674|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.7|TWO_SIDED|95.0|-0.61|0.41||P-value is for Baseline-0300 hrs.|ANCOVA|||||0.41|-0.61|0.700
91706675|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.399|TWO_SIDED|95.0|-0.23|0.58||P-value is for Endpoint, up to 24 wk-AM Pre-Meal.|ANCOVA|||||0.58|-0.23|0.399
91706676|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.248|TWO_SIDED|95.0|-0.18|0.68||P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.|ANCOVA|||||0.68|-0.18|0.248
91706677|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.883|TWO_SIDED|95.0|-0.44|0.38||P-value is for Endpoint, up to 24 wk-MD Pre-Meal.|ANCOVA|||||0.38|-0.44|0.883
91706678|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.687|TWO_SIDED|95.0|-0.34|0.52||P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.|ANCOVA|||||0.52|-0.34|0.687
91706679|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.24|0.65||P-value is for Endpoint, up to 24 wk-EV Pre-Meal.|ANCOVA|||||0.65|-0.24|0.364
91706680|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.03|TWO_SIDED|95.0|-0.95|-0.05||P-value is for Endpoint, up to 24 wk- Bed Time.|ANCOVA|||||-0.05|-0.95|0.030
91706681|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45||||0.033|TWO_SIDED|95.0|-0.86|-0.04||P-value is for Endpoint, up to 24 wk-0300 hrs.|ANCOVA|||||-0.04|-0.86|0.033
91706682|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.23|TWO_SIDED|95.0|-0.68|0.16||P-value is for Endpoint, up to 52 wk-AM Pre-Meal.|ANCOVA|||||0.16|-0.68|0.230
91706683|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.148|TWO_SIDED|95.0|-0.76|0.11||P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.|ANCOVA|||||0.11|-0.76|0.148
91706684|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.866|TWO_SIDED|95.0|-0.43|0.36||P-value is for Endpoint, up to 52 wk-MD Pre-Meal.|ANCOVA|||||0.36|-0.43|0.866
91706685|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.545|TWO_SIDED|95.0|-0.56|0.3||P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.|ANCOVA|||||0.30|-0.56|0.545
91706686|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.955|TWO_SIDED|95.0|-0.44|0.42||P-value is for Endpoint, up to 52 wk-EV Pre-Meal.|ANCOVA|||||0.42|-0.44|0.955
91706687|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.031|TWO_SIDED|95.0|-0.92|-0.04||P-value is for Endpoint, up to 52 wk-Bed Time.|ANCOVA|||||-0.04|-0.92|0.031
91706688|NCT01421147|183307548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.355|TWO_SIDED|95.0|-0.65|0.23||P-vale is for Endpoint, up to 52 wk-0300 hrs.|ANCOVA|||||0.23|-0.65|0.355
91706689|NCT01421147|183307549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.32|TWO_SIDED|95.0|-0.52|0.17||P-value is for Baseline.|ANCOVA|||||0.17|-0.52|0.320
91706690|NCT01421147|183307549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.781|TWO_SIDED|95.0|-0.33|0.25||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||0.25|-0.33|0.781
91706691|NCT01421147|183307549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.06|TWO_SIDED|95.0|-0.53|0.01||P-value is for Endpoint, up to 52 weeks.|ANCOVA|||||0.01|-0.53|0.060
91706692|NCT01421147|183307550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||P-value is for change at 6 weeks.|ANCOVA|||||0.29|-0.23|0.823
91706693|NCT01421147|183307550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.541|TWO_SIDED|95.0|-0.25|0.47||P-value is for change at 12 weeks.|ANCOVA|||||0.47|-0.25|0.541
91706694|NCT01421147|183307550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.435|TWO_SIDED|95.0|-0.25|0.59||P-value is for change at 18 weeks.|ANCOVA|||||0.59|-0.25|0.435
91706695|NCT01421147|183307550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.32|TWO_SIDED|95.0|-0.23|0.71||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||0.71|-0.23|0.320
91706696|NCT01421147|183307550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.253|TWO_SIDED|95.0|-0.25|0.93||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.93|-0.25|0.253
91706697|NCT01421147|183307551|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.401|TWO_SIDED|95.0|-0.86|2.15||P-value is for Baseline-Behavior TS.|ANCOVA|||||2.15|-0.86|0.401
91706698|NCT01421147|183307551|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.778|TWO_SIDED|95.0|-1.16|1.55||P-value is for 24 weeks-Behavior TS|ANCOVA|||||1.55|-1.16|0.778
91706699|NCT01421147|183307551|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.804|TWO_SIDED|95.0|-1.12|1.45||P-value is for Endpoint, up to 52 weeks-Behavior TS.|ANCOVA|||||1.45|-1.12|0.804
91706700|NCT01421147|183307551|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21||||0.304||95.0|-1.1|3.51||P-value is for Baseline-Worry TS.|ANCOVA|||||3.51|-1.10|0.304
91706701|NCT01421147|183307551|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.323|TWO_SIDED|95.0|-1.1|3.34||P-value is for 24 weeks-Worry TS.|ANCOVA|||||3.34|-1.10|0.323
91706702|NCT01421147|183307551|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.824||95.0|-1.92|2.41||P-value is for Endpoint, up to 52 weeks-Worry TS.|ANCOVA|||||2.41|-1.92|0.824
91706703|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.77||||0.681|TWO_SIDED|95.0|-4.42|2.89||P-value is for IR-Baseline.|ANCOVA|||||2.89|-4.42|0.681
91706704|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.744|TWO_SIDED|95.0|-2.79|3.9||P-value is for IR-24 weeks.|ANCOVA|||||3.90|-2.79|0.744
91706705|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94||||0.582|TWO_SIDED|95.0|-4.29|2.41||P-value is for IR-Endpoint, up to 52 weeks.|ANCOVA|||||2.41|-4.29|0.582
91706706|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.694|TWO_SIDED|95.0|-3.26|4.89||P-value is for LF-Baseline.|ANCOVA|||||4.89|-3.26|0.694
91706707|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.673|TWO_SIDED|95.0|-3.08|4.77||P-value is for LF-24 weeks.|ANCOVA|||||4.77|-3.08|0.673
91706708|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91||||0.645|TWO_SIDED|95.0|-4.79|2.97||P-value is for LF-Endpoint, up to 52 weeks.|ANCOVA|||||2.97|-4.79|0.645
91706709|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.961|TWO_SIDED|95.0|-3.62|3.81||P-value is for GC-Baseline.|ANCOVA|||||3.81|-3.62|0.961
91706710|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.463|TWO_SIDED|95.0|-2.1|4.61||P-value is for GC-24 weeks.|ANCOVA|||||4.61|-2.10|0.463
91706711|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.609|TWO_SIDED|95.0|-2.59|4.41||P-value is for GC-Endpoint, up to 52 weeks.|ANCOVA|||||4.41|-2.59|0.609
91706712|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61||||0.708|TWO_SIDED|95.0|-3.81|2.59||P-value is for HC-Baseline.|ANCOVA|||||2.59|-3.81|0.708
91706713|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.51|TWO_SIDED|95.0|-4.09|2.03||P-value is for HC-24 weeks.|ANCOVA|||||2.03|-4.09|0.510
91706714|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26||||0.422|TWO_SIDED|95.0|-4.34|1.82||P-value is for HC-Endpoint, up to 52 weeks.|ANCOVA|||||1.82|-4.34|0.422
91706715|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.53||||0.367|TWO_SIDED|95.0|-4.85|1.8||P-value is for IDD-Baseline.|ANCOVA|||||1.80|-4.85|0.367
91706716|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.786|TWO_SIDED|95.0|-2.54|3.35||P-value is for IDD-24 weeks.|ANCOVA|||||3.35|-2.54|0.786
91706717|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.845|TWO_SIDED|95.0|-3.16|2.59||P-value is for IDD-Endpoint, up to 52 weeks.|ANCOVA|||||2.59|-3.16|0.845
91706718|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.676|TWO_SIDED|95.0|-3.36|2.18||P-value is for ITSQ Total-Baseline.|ANCOVA|||||2.18|-3.36|0.676
91706719|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.862|TWO_SIDED|95.0|-2.33|2.78||P-value is for ITSQ Total-24 weeks.|ANCOVA|||||2.78|-2.33|0.862
91706720|NCT01421147|183307552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.685|TWO_SIDED|95.0|-3.15|2.07||P-value is for ITSQ Total-Endpoint, up to 52 weeks.|ANCOVA|||||2.07|-3.15|0.685
91706721|NCT01421147|183307553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.014||||0.235|TWO_SIDED|95.0|-0.009|0.036||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||0.036|-0.009|0.235
91706722|NCT01421147|183307553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.726|TWO_SIDED|95.0|-0.026|0.038||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||0.038|-0.026|0.726
91706723|NCT01421147|183307553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.019||||0.377|TWO_SIDED|95.0|-0.023|0.062||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||0.062|-0.023|0.377
91706724|NCT01421147|183307553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.018||||0.159|TWO_SIDED|95.0|-0.007|0.042||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||0.042|-0.007|0.159
91706725|NCT01421147|183307553|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.001||||0.957|TWO_SIDED|95.0|-0.034|0.032||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||0.032|-0.034|0.957
91706726|NCT01421147|183307553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.45|TWO_SIDED|95.0|-0.028|0.062||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||0.062|-0.028|0.450
91706727|NCT01421147|183307554|SUPERIORITY_OR_OTHER||LS Mean Difference|1.724||||0.096|TWO_SIDED|95.0|-0.308|3.755||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||3.755|-0.308|0.096
91706728|NCT01421147|183307554|SUPERIORITY_OR_OTHER||LS Mean Difference|1.267||||0.374|TWO_SIDED|95.0|-1.531|4.065||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||4.065|-1.531|0.374
91706729|NCT01421147|183307554|SUPERIORITY_OR_OTHER||LS Mean Difference|2.964||||0.151|TWO_SIDED|95.0|-1.081|7.01||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||7.010|-1.081|0.151
91706730|NCT01421147|183307554|SUPERIORITY_OR_OTHER||LS Mean Difference|2.059||||0.072|TWO_SIDED|95.0|-0.187|4.305||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||4.305|-0.187|0.072
91706731|NCT01421147|183307554|SUPERIORITY_OR_OTHER||LS Mean Difference|0.702||||0.617|TWO_SIDED|95.0|-2.058|3.462||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||3.462|-2.058|0.617
91706732|NCT01421147|183307554|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.188|TWO_SIDED|95.0|-1.37|6.971||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||6.971|-1.370|0.188
91706733|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.015||||||P-value is for HbA1c- at Baseline \<7.0 %.|Fisher Exact|||||||0.015
91706734|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for HbA1c- at Baseline ≤6.5%.|Fisher Exact|||||||0.606
91706735|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for HbA1c- at 6 weeks \<7.0%.|Fisher Exact|||||||0.012
91706736|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for HbA1c- at 6 weeks ≤6.5%.|Fisher Exact|||||||0.053
91706737|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.398||||||P-value is for HbA1c- at 12 weeks \<7.0%.|Fisher Exact|||||||0.398
91706738|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for HbA1c- at 12 weeks ≤6.5%.|Fisher Exact|||||||0.170
91706739|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.926||||||P-value is for HbA1c- at 24 weeks \<7.0%.|Fisher Exact|||||||0.926
91706740|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.824||||||P-value is for HbA1c- at 24 weeks ≤6.5%.|Fisher Exact|||||||0.824
91706741|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.385||||||P-value is for HbA1c- at 36 weeks \<7.0%.|Fisher Exact|||||||0.385
91706742|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.408||||||P-value is for HbA1c- at 36 weeks ≤6.5%.|Fisher Exact|||||||0.408
91706743|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.551||||||P-value is for HbA1c- at 52 weeks \<7.0%.|Fisher Exact|||||||0.551
91706744|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for HbA1c- at 52 weeks ≤6.5%.|Fisher Exact|||||||0.900
91706745|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.646||||||P-value is for HbA1c- Endpoint, up to 24 weeks \<7.0%.|Fisher Exact|||||||0.646
91706746|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.|Fisher Exact|||||||0.661
91706747|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.209||||||P-value is for HbA1c- Endpoint, up to 52 weeks \<7.0%.|Fisher Exact|||||||0.209
91706748|NCT01421147|183307555|SUPERIORITY_OR_OTHER|||||||0.54||||||P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.|Fisher Exact|||||||0.540
91706749|NCT01421147|183307556|SUPERIORITY_OR_OTHER|||||||0.703||||||P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.|Fisher Exact|||||||0.703
91706750|NCT01421147|183307556|SUPERIORITY_OR_OTHER|||||||0.495||||||P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.|Fisher Exact|||||||0.495
91518774|NCT04951336|182911762|SUPERIORITY|age was included as a covariate||||||0.002||||||p \< 0.05.|Mixed Models Analysis|F(2,157)=4.286. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
91706751|NCT01421147|183307556|SUPERIORITY_OR_OTHER|||||||0.174||||||P-value is for Severe Events-24 wk.|Fisher Exact|||||||0.174
91706752|NCT01421147|183307556|SUPERIORITY_OR_OTHER|||||||0.828||||||P-value is for Severe Events-52 wk.|Fisher Exact|||||||0.828
91706753|NCT01421147|183307556|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Fisher Exact|||||||0.661
91706754|NCT01421147|183307556|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Fisher Exact|||||||0.606
91706755|NCT01421147|183307557|SUPERIORITY_OR_OTHER|||||||0.717||||||P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.717
91706756|NCT01421147|183307557|SUPERIORITY_OR_OTHER|||||||0.163||||||P-value is for Severe Events-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.163
91706757|NCT01421147|183307557|SUPERIORITY_OR_OTHER|||||||0.669||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.669
91706758|NCT01421147|183307557|SUPERIORITY_OR_OTHER|||||||0.738||||||P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.738
91706759|NCT01421147|183307557|SUPERIORITY_OR_OTHER|||||||0.826||||||P-value is for Severe Events-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.826
91706760|NCT01421147|183307557|SUPERIORITY_OR_OTHER|||||||0.25||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.250
91706761|NCT00904917|183307564|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||.015
91706762|NCT00904917|183307566|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||.037
91706763|NCT05025332|183307636|OTHER|||||||0.0039|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots and histograms/bar charts were created at the EOT visit with plots for all participants.||||.0039
91706764|NCT05025332|183307637|OTHER|||||||0.0234|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0234
91706765|NCT05025332|183307638|OTHER|Change from baseline||||||0.0313|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0313
91706766|NCT05025332|183307639|OTHER|Change from baseline||||||0.0039|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0039
91706767|NCT05025332|183307640|OTHER|change from baseline||||||0.1934|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.1934
91706768|NCT05025332|183307641|OTHER|Change from baseline||||||0.748|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7480
91706769|NCT05025332|183307642|OTHER|Change from baseline||||||0.3203|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3203
91706770|NCT05025332|183307643|OTHER|change from baseline||||||0.3574|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3574
91518775|NCT04951336|182911763|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|F(8,325)=1.898. Age was included as a covariate in this analysis.||LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||0.060
91518776|NCT04951336|182911764|SUPERIORITY|LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||||0.326|||||||Mixed Models Analysis|F(8,309)=1.156. Age was included as a covariate in this analysis.||||||0.326
91706771|NCT05025332|183307644|OTHER|Change from baseline||||||0.4131|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.4131
91706772|NCT05025332|183307645|OTHER|change from baseline||||||0.9063|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.9063
91706773|NCT05025332|183307646|OTHER|Change from baseline||||||1|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||1.00
91706774|NCT05025332|183307647|OTHER|Change from baseline||||||0.7002|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7002
91706775|NCT05025332|183307648|OTHER|Change from baseline||||||0.375|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3750
91706776|NCT05025332|183307649|OTHER|||||||0.7695|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7695
91706777|NCT05025332|183307650|OTHER|||||||0.2402|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.2402
91706778|NCT01031004|183307673|SUPERIORITY_OR_OTHER|||||||0.0466||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.0466
91706779|NCT01031004|183307674|SUPERIORITY_OR_OTHER|||||||0.1069||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.1069
91706780|NCT01031004|183307675|SUPERIORITY_OR_OTHER|||||||0.4605||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.4605
91706781|NCT01031004|183307676|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.5774
91706782|NCT01031004|183307677|SUPERIORITY_OR_OTHER|||||||0.6403||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B will not be statistically different from etafilcon A.||||0.6403
91706783|NCT01031004|183307678|SUPERIORITY_OR_OTHER|||||||0.7217||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.7217
91706784|NCT04727528|183307702|SUPERIORITY||Odds Ratio (OR)|56.2||||0.001|TWO_SIDED|95.0|5.6|563.6|||Wald Chi-Squared test||Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor.|||563.6|5.6|0.001
91706785|NCT04727528|183307703|SUPERIORITY||Least-squares mean|1.64|STANDARD_ERROR_OF_MEAN|0.81||0.05|TWO_SIDED|95.0|0.0|3.29|||t-test, 2 sided|||Difference between groups||3.29|-0.00|0.050
91706786|NCT04727528|183307704|SUPERIORITY||Odds Ratio (OR)|3.2||||0.153|TWO_SIDED|95.0|0.6|15.8|||Wald Chi-Squared test|||Comparison between groups||15.8|0.6|0.153
91706787|NCT04727528|183307705|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
91706788|NCT04727528|183307706|SUPERIORITY||Odds Ratio (OR)|2.2||||0.271|TWO_SIDED|95.0|0.5|8.6|||Wald Chi-Squared test|||Comparison between groups||8.6|0.5|0.271
91706789|NCT04727528|183307707|SUPERIORITY||Odds Ratio (OR)|10.8||||0.039|TWO_SIDED|95.0|1.1|102.8|||Wald Chi-Squared test|||Comparison between groups||102.8|1.1|0.039
91706790|NCT04727528|183307708|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
91706791|NCT04656301|183307710|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|degrees of freedom = 1.92||||||<0.001
91706792|NCT01964989|183307722|SUPERIORITY|Relative vaccine efficacy (rVE; ≥6 to \<72 months) rVE = (1-HR) is the relative vaccine efficacy of aQIV and HR is defined as hazard ratio between aQIV and non adjuvanted comparator.|Cox Proportional Hazard|-0.67|||||TWO_SIDED|95.0|-19.81|15.41||||||||15.41|-19.81|
91644159|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.974|||<|0.0001|TWO_SIDED|95.0|4.867|5.081|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)||5.081|4.867|<.0001
91518777|NCT03073148|182911793|EQUIVALENCE|alpha = 0.05||||||0.3577|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3577
91644160|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.984|||<|0.0001|TWO_SIDED|95.0|4.886|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)||5.082|4.886|<.0001
91644161|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.975|||<|0.0001|TWO_SIDED|95.0|4.868|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)||5.082|4.868|<.0001
91644162|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.49|||<|0.0001|TWO_SIDED|95.0|3.367|3.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)||3.612|3.367|<.0001
91518778|NCT03073148|182911793|EQUIVALENCE|alpha = 0.05||||||0.9917|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.9917
91518779|NCT03073148|182911794|EQUIVALENCE|alpha = 0.05||||||0.3239|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3239
91706793|NCT01964989|183307729|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% confidence interval (CI) on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.91|||||TWO_SIDED|95.0|1.8|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.8|
91518780|NCT03073148|182911794|EQUIVALENCE|alpha = 0.05||||||0.8343|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.8343
91518781|NCT03073148|182911795|EQUIVALENCE|alpha = 0.05||||||0.4134|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.4134
91518782|NCT03073148|182911795|EQUIVALENCE|alpha = 0.05||||||0.1192|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1192
91518783|NCT03073148|182911797|EQUIVALENCE|alpha = 0.05||||||0.1753||||||Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.|ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1753
91518784|NCT03073148|182911797|EQUIVALENCE|alpha = 0.05||||||0.1843|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1843
91518785|NCT03073148|182911798|EQUIVALENCE|alpha = 0.05||||||0.0765|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.0765
91518786|NCT03073148|182911798|EQUIVALENCE|alpha = 0.05||||||0.152|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1520
91518787|NCT00833560|182911821|SUPERIORITY_OR_OTHER||Percentage of participants with response|85.4|||<|0.0001|TWO_SIDED|95.0|81.5|88.8|||Two - sided binomial test|||||88.8|81.5|<0.0001
91518788|NCT00833560|182911822|SUPERIORITY_OR_OTHER||Percentage of participants with response|87.7|||<|0.0001|TWO_SIDED|95.0|83.6|91.0|||Two-sided binomial test|||||91.0|83.6|<0.0001
91518789|NCT00414817|182911825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.002|TWO_SIDED|95.0|0.006|0.03|||Regression, Linear|2-tailed p-value based on linear regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|Estimated adherence was approximately 2 percentage points higher for intervention group than for usual care group.|In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.||.030|.006|.002
91518790|NCT00414817|182911826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.175|TWO_SIDED|95.0|-0.23|0.04|||Regression, Linear|2-tailed p-value adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline adherence.||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||0.04|-0.23|0.175
91706794|NCT01964989|183307729|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
91706795|NCT01964989|183307729|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.6|1.8||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.8|1.6|
91581598|NCT02349425|183053217|SUPERIORITY||Estimated percent change|-25.165||||0.0267|TWO_SIDED|95.0|-42.014|-3.421|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.4210|-42.014|0.0267
91706796|NCT01964989|183307729|OTHER||GMT ratio|1.57|||||TWO_SIDED|95.0|1.4|1.7||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.7|1.4|
91518791|NCT00414817|182911827|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.852|TWO_SIDED|95.0|0.96|1.06||2-tailed p-value based on overdispersed Poisson regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|overdispersed Poisson regression|||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||1.06|0.96|0.852
91518792|NCT00440531|182911830|SUPERIORITY_OR_OTHER||single-group percentage|75.7||||||95.0|68.0|82.2||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||82.20|68|
91518793|NCT00440531|182911830|SUPERIORITY_OR_OTHER||single-group percentage|68.0||||||95.0|59.8|75.5||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||75.50|59.80|
91706797|NCT01964989|183307729|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.19|||||TWO_SIDED|95.0|2.0|2.4||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.4|2.0|
91644163|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.347|||<|0.0001|TWO_SIDED|95.0|3.212|3.483|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)||3.483|3.212|<.0001
91518794|NCT00440531|182911831|SUPERIORITY_OR_OTHER||Single-Group Percentage|84.0||||||95.0|77.0|89.6||||||No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) for ENGERIX-B™ at 1 month post vaccination 3, among subjects who were seronegative at baseline.||89.60|77|
91518795|NCT02249819|182911935|EQUIVALENCE|Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).||||||0.694||||||The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).|wilcoxon sign-ranked test|Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.||||||0.694
91518796|NCT02570126|182911937|NON_INFERIORITY|Criterion for the Varilrix HSA-free vaccine as compared to Varilrix™ vaccine, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR\_HSA\_F minus VAR) in incidence of fever \> 39.0°C (\> 102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%|Difference in percentage between groups|-1.29|||||TWO_SIDED|95.0|-3.72|1.08|||||Power obtained using PASS 2005 (Likelihood Score \[Miettinen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=2.5%|Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever \> 39.0°C (\> 102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR\_HSA\_F Group minus VAR Group)||1.08|-3.72|
91644164|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.539|||<|0.0001|TWO_SIDED|95.0|3.418|3.66|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)||3.660|3.418|<.0001
91706798|NCT01964989|183307729|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
91518797|NCT05224050|182911965|OTHER|A paired-samples t-test was conducted to examine differences in the DASS-21 total score from baseline to 2-weeks post-quit.|Mean Difference (Final Values)|-2.04|STANDARD_DEVIATION|10.54||0.4|TWO_SIDED|95.0|-6.98|2.89||The threshold for statistical significance was p\<0.05|t-test, 2 sided||Mean difference represents the difference of the mean for the DASS-21 total scores at Baseline and at 2-weeks post-quit. The reported estimated value is based on data from the n=20 who attended their 2-weeks post-quit session|||2.89|-6.98|0.40
91706799|NCT01964989|183307729|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.27|||||TWO_SIDED|95.0|2.0|2.6||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.6|2.0|
91613883|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.054||||0.0064|TWO_SIDED|95.0|1.224|3.447|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.447|1.224|0.0064
91518798|NCT05224050|182911965|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 2-weeks post-quit to 1-month post-quit.|Mean Difference (Final Values)|-2.43|STANDARD_DEVIATION|9.15||0.26|TWO_SIDED|95.0|-6.84|1.98||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 2-weeks post-quit and 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.98|-6.84|0.26
91518799|NCT05224050|182911965|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 1-month post-quit to 3-month follow up.|Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|6.49||0.11|TWO_SIDED|95.0|-6.21|0.71||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 1-month post-quit and 3-month follow up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow up session.|||0.71|-6.21|0.11
91518800|NCT05224050|182911968|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline to Quit Day.|Mean Difference (Final Values)|13.7|STANDARD_DEVIATION|8.63|<|0.001|TWO_SIDED|95.0|9.88|17.53||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Baseline to Quit Date. The reported estimated value is based on data from the n=22 participants who attended their Quit Date session.|||17.53|9.88|<0.001
91706800|NCT01964989|183307729|OTHER||GMT ratio|1.8|||||TWO_SIDED|95.0|1.6|2.1||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.1|1.6|
91706801|NCT01964989|183307731|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.0||||||aQIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.0|0.8|
91706802|NCT01964989|183307731|OTHER||GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.1||||||aQIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.9|
91518801|NCT05224050|182911968|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit.|Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|2.02||0.8|TWO_SIDED|95.0|-0.83|1.06||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Quit Date to 2-weeks Post-Quit. The reported estimated value is based on data from the n=20 participants who attended their 2-weeks post-quit session.|||1.06|-0.83|0.80
91518802|NCT05224050|182911968|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.97||0.97|TWO_SIDED|95.0|-1.41|1.45||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 2-weeks post-quit to 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.45|-1.41|0.97
91706803|NCT01964989|183307731|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
91518803|NCT05224050|182911968|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up.|Mean Difference (Final Values)|-2.17|STANDARD_DEVIATION|3.75||0.04|TWO_SIDED|95.0|-4.17|-0.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 1-month post-quit to 3-month follow-up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow-up session.|||-0.17|-4.17|0.04
91518804|NCT00917579|182911971|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|95.34||||||90.0|91.33|99.52|||ANOVA|Values were back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||99.52|91.33|
91581599|NCT02349425|183053217|SUPERIORITY||Estimated percent change|-37.146||||0.0198|TWO_SIDED|95.0|-57.345|-7.3821|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-7.3821|-57.345|0.0198
91706804|NCT01964989|183307731|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
91581600|NCT02349425|183053217|SUPERIORITY||Estimated percent change|-55.92||||0.0006|TWO_SIDED|95.0|-71.923|-30.797|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.797|-71.923|0.0006
91706805|NCT01964989|183307731|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
91581601|NCT02349425|183053222|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.003|TWO_SIDED|95.0|-31.2|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-31.2|0.003
91581602|NCT02349425|183053222|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-36.7|-12.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-12.1|-36.7|<0.001
91518805|NCT00917579|182911972|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both the AUCinf and Cmax fell within (80%, 125%). AUCinf method of determination includes AUC last calculated value.|ratio of adjusted geometric means|95.79||||||90.0|91.07|100.76|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.76|91.07|
91581603|NCT02349425|183053222|SUPERIORITY||Mean Difference (Final Values)|-29.3||||0.005|TWO_SIDED|95.0|-49.0|-9.5|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model.||||-9.5|-49.0|0.005
91581604|NCT02349425|183053222|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED|95.0|-44.6|-14.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-14.7|-44.6|<0.001
91518806|NCT00917579|182911973|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|91.41||||||90.0|83.39|100.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.20|83.39|
91518807|NCT01627327|182911976|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.022||||0.201|TWO_SIDED|95.0|-0.012|0.055|||ANCOVA|||||0.055|-0.012|0.201
91518808|NCT01175850|182911980|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Z-test|Z-test of two proportions was used to compare treatment groups for all randomized subjects.||||||<0.001
91644165|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.419|||<|0.0001|TWO_SIDED|95.0|3.284|3.554|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)||3.554|3.284|<.0001
91518809|NCT01175850|182911981|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91518810|NCT01175850|182911982|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91518811|NCT01175850|182911983|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
91706806|NCT01964989|183307731|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
91706807|NCT01964989|183307731|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
91518812|NCT01175850|182911984|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91518813|NCT01175850|182911985|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91706808|NCT01964989|183307731|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.7|1.2||||||TIV/QIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.2|0.7|
91518814|NCT01175850|182911986|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Chi-squared|||||||0.859
91518815|NCT01175850|182911987|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
91518816|NCT01175850|182911988|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
91518817|NCT01175850|182911989|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91518818|NCT01175850|182911990|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
91518819|NCT01175850|182911991|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
91518820|NCT01175850|182911992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91518821|NCT01175850|182911993|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Chi-squared|||||||0.095
91518822|NCT01175850|182911994|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Chi-squared|||||||0.590
91518823|NCT01175850|182911995|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
91518824|NCT01175850|182911996|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
91518825|NCT01175850|182911997|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
91518826|NCT01175850|182911998|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
91518827|NCT01137474|182912000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.9251||0.001|TWO_SIDED|95.0|-4.87|-1.24||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is \>80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.||-1.24|-4.87|0.0010
91518828|NCT01137474|182912001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0673|<|0.0001|TWO_SIDED|95.0|-0.59|-0.33||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is \>98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.||-0.33|-0.59|<0.0001
91518829|NCT01137474|182912002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|1.0091||0.0043|TWO_SIDED|95.0|-4.88|-0.91||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|ANCOVA|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||-0.91|-4.88|0.0043
91518830|NCT01137474|182912003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.5811||0.0843|TWO_SIDED|95.0|-2.15|0.14||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.||0.14|-2.15|0.0843
91518831|NCT01137474|182912004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.6866|||TWO_SIDED|95.0|-1.96|0.73||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|ANCOVA|||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||0.73|-1.96|
91518832|NCT01137474|182912005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.0717|||TWO_SIDED|95.0|-0.46|-0.18||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.||-0.18|-0.46|
91518833|NCT02161133|182912006|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.62||0.712|TWO_SIDED||||||Mixed Models Analysis|||||||0.712
91706809|NCT01964989|183307733|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|8.2|||||TWO_SIDED|95.0|5.0|11.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||11.3|5.0|
91518834|NCT02161133|182912007|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.48||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
91518835|NCT02161133|182912008|SUPERIORITY||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|10.45||0.244|TWO_SIDED||||||Mixed Models Analysis|||||||0.244
91518836|NCT02161133|182912009|SUPERIORITY||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|1.95||0.057|TWO_SIDED||||||Mixed Models Analysis|||||||0.057
91518837|NCT02161133|182912010|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.57||0.382|TWO_SIDED||||||Mixed Models Analysis|||||||0.382
91518838|NCT02161133|182912011|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.703|TWO_SIDED||||||Mixed Models Analysis|||||||0.703
91518839|NCT02161133|182912012|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.36||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
91518840|NCT02161133|182912013|SUPERIORITY||Mean Difference (Final Values)|-7.28|STANDARD_ERROR_OF_MEAN|2.93||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
91518841|NCT01515410|182912014|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.86||||0.0471||95.0|-13.62|-0.09||This p-value indicates statistical significance at the 0.05 level.|ANCOVA|No subjects early-terminated from the study.||"Percent OFF Time (%)"||-0.09|-13.62|0.0471
91518842|NCT00868439|182912019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||< 0.001
91518843|NCT00868439|182912020|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.027|TWO_SIDED||||||Fisher Exact|||||||= 0.027
91518844|NCT00868439|182912021|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED||||||Fisher Exact|||||||= 0.101
91518845|NCT00868439|182912022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||Fisher Exact|||||||0.022
91518846|NCT00868439|182912023|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.136|TWO_SIDED||||||Fisher Exact|||||||= 0.136
91706810|NCT01964989|183307733|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|5.2|||||TWO_SIDED|95.0|1.9|8.4||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||8.4|1.9|
91706811|NCT01964989|183307733|SUPERIORITY||Seroconversion difference|21.3|||||TWO_SIDED|95.0|18.1|24.5||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||24.5|18.1|
91706812|NCT01964989|183307733|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|13.6|||||TWO_SIDED|95.0|10.0|17.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||17.3|10.0|
91518847|NCT00868439|182912024|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Fisher Exact|||||||= 0.015
91581605|NCT02349425|183053223|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.332|TWO_SIDED|95.0|-21.0|7.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||7.2|-21.0|0.332
91706813|NCT01964989|183307734|OTHER||Mean Difference (Final Values)|11.5|||||TWO_SIDED|95.0|9.4|13.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||13.7|9.4|
91706814|NCT01964989|183307734|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||9.7|6.1|
91518848|NCT04109703|182912026|OTHER|The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.|||||<|0.05|||||||Regression, Linear|Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.||Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.||||<0.05
91518849|NCT00338884|182912028|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|35.3|||||TWO_SIDED|95.0|26.7|44.8|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||44.8|26.7|
91518850|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.5581|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5581
91518851|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.7635|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.7635
91518852|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.8366|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8366
91518853|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0278
91518854|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.1988|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1988
91518855|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.2898|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2898
91518856|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.3567|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3567
91518857|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.4547|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.4547
91518858|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
91518859|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.3259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3259
91518860|NCT00338884|182912034|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
91518861|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.7154|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7154
91518862|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6263
91518863|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.9608|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9608
91518864|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0300
91518865|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0927
91518866|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2873
91518867|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.3018|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3018
91518868|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.4161|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4161
91518869|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3069
91518870|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2920
91518871|NCT00338884|182912035|SUPERIORITY_OR_OTHER|||||||0.2409|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2409
91518872|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
91518873|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.6251|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.6251
91518874|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1639
91518875|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.2782|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.2782
91518876|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.8627|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.8627
91518877|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4620
91518878|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.7575|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.7575
91518879|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.3566|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3566
91518880|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
91518881|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.8758|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8758
91518882|NCT00338884|182912037|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
91518883|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
91518884|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.8555|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8555
91518885|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.2259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2259
91518886|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.2074|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2074
91518887|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.4779|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4779
91644166|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.492|||<|0.0001|TWO_SIDED|95.0|3.373|3.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)||3.611|3.373|<.0001
91518888|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.3628|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3628
91518889|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5460
91518890|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.3637|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3637
91518891|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.2229|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2229
91518892|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.9759|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9759
91518893|NCT00338884|182912038|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
91518894|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
91518895|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.9625|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.9625
91518896|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8519
91518897|NCT00338884|182912040|SUPERIORITY_OR_OTHER||Wilcoxon Rank Sum Test|||||0.0513|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0513
91518898|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.4051|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.4051
91518899|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.2548|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2548
91518900|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.5091|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.5091
91518901|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.3133|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3133
91518902|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.9278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.9278
91518903|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.4070
91518904|NCT00338884|182912040|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2703
91518905|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
91518906|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.8286|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8286
91518907|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.6867|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6867
91518908|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0450
91706815|NCT01964989|183307734|OTHER||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|18.1|25.6||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||25.6|18.1|
91518909|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1740
91518910|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2703
91518911|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.3659|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3659
91518912|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.3391|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3391
91518913|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9800
91518914|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3350
91518915|NCT00338884|182912041|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
91518916|NCT00338884|182912044|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0680
91518917|NCT00338884|182912045|SUPERIORITY_OR_OTHER|||||||0.1159|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1159
91518918|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.8519
91518919|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.5879|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.5879
91518920|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.4757|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.4757
91518921|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.1933|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1933
91518922|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.4187|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4187
91518923|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.3795|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3795
91518924|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||1.0000
91518925|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.6333|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.6333
91518926|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.8679|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8679
91518927|NCT00338884|182912047|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.5920
91518928|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.6939|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6939
91518929|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.5871|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5871
91518930|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.4572|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4572
91518931|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1120
91706816|NCT01964989|183307734|OTHER||Mean Difference (Final Values)|20.9|||||TWO_SIDED|95.0|15.9|25.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||25.7|15.9|
91518932|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.4896|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4896
91518933|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.2369|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2369
91518934|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.6709|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6709
91518935|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.6382|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6382
91518936|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.8481|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8481
91518937|NCT00338884|182912048|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
91518938|NCT00338884|182912050|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0292
91518939|NCT00338884|182912051|SUPERIORITY_OR_OTHER|||||||0.1087|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1087
91706817|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|5.9|9.7||||||Difference in HI titers ≥ 1:110 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.7|5.9|
91518940|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.3386|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.3386
91706818|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|7.8|11.9||||||Difference in HI Titers ≥ 1:151 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||11.9|7.8|
91518941|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.1949|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1949
91518942|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.7037|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.7037
91518943|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.5748|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.5748
91518944|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.7470
91518945|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.4703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.4703
91518946|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.8162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.8162
91518947|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.5465|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.5465
91518948|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.3495|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3495
91518949|NCT00338884|182912053|SUPERIORITY_OR_OTHER|||||||0.6397|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.6397
91518950|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.4632|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4632
91518951|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.1701|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1701
91518952|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.8204|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8204
91518953|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.5162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5162
91706819|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|16.1|||||TWO_SIDED|95.0|13.5|18.7||||||Difference in HI Titers ≥ 1:215 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||18.7|13.5|
91518954|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.9437|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9437
91518955|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.4013|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4013
91518956|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.9595|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9595
91518957|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.6249|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6249
91518958|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
91518959|NCT00338884|182912054|SUPERIORITY_OR_OTHER|||||||0.8263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8263
91518960|NCT03492281|182912062|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2||Hypothesis testing was performed for vibegron minus placebo.|Mixed Model for Repeated Measures (MMRM)|||||-0.2|-0.8|<0.001
91518961|NCT03492281|182912062|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16|=|0.0988|TWO_SIDED|95.0|-0.6|0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.1|-0.6|=0.0988
91518962|NCT03492281|182912063|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.3|-0.9|<0.0001
91518963|NCT03492281|182912063|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15|=|0.0123|TWO_SIDED|95.0|-0.7|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.7|=0.0123
91518964|NCT03492281|182912064|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22|=|0.002|TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-1.1|=0.0020
91518965|NCT03492281|182912064|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23|=|0.0648|TWO_SIDED|95.0|-0.9|0.0||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.0|-0.9|=0.0648
91518966|NCT03492281|182912065|SUPERIORITY||Difference in percentage|16.5|||<|0.0001|TWO_SIDED|95.0|9.7|23.4|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||23.4|9.7|<0.0001
91518967|NCT03492281|182912065|SUPERIORITY||Difference in percentage|9.4|||=|0.012|TWO_SIDED|95.0|2.1|16.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||16.7|2.1|=0.0120
91518968|NCT03492281|182912066|SUPERIORITY||Difference in percentage|6.3|||=|0.036|TWO_SIDED|95.0|0.4|12.1|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||12.1|0.4|=0.0360
91518969|NCT03492281|182912066|SUPERIORITY||Difference in percentage|1.9|||=|0.5447|TWO_SIDED|95.0|-4.1|7.8|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||7.8|-4.1|=0.5447
91518970|NCT03492281|182912067|SUPERIORITY||Difference in percentage|6.8|||=|0.0235|TWO_SIDED|95.0|0.9|12.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||12.7|0.9|=0.0235
91518971|NCT03492281|182912067|SUPERIORITY||Difference in percentage|3.7|||=|0.24|TWO_SIDED|95.0|-2.5|10.0|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||10.0|-2.5|=0.2400
91518972|NCT03492281|182912068|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.4|-1.0|<0.0001
91518973|NCT03492281|182912068|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|=|0.0074|TWO_SIDED|95.0|-0.8|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.8|=0.0074
91706820|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|19.8|26.4||||||Difference in HI Titers ≥ 1:330 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||26.4|19.8|
91518974|NCT03492281|182912069|SUPERIORITY||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.24|=|0.0039|TWO_SIDED|95.0|1.2|6.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||6.0|1.2|=0.0039
91518975|NCT03492281|182912069|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.32|=|0.021|TWO_SIDED|95.0|0.5|5.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||5.7|0.5|=0.0210
91518976|NCT03492281|182912070|SUPERIORITY||Least Squares Mean Difference|21.2|STANDARD_ERROR_OF_MEAN|3.52|<|0.0001|TWO_SIDED|95.0|14.3|28.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||28.1|14.3|<0.0001
91518977|NCT03492281|182912070|SUPERIORITY||Least Squares Mean Difference|13.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|5.9|20.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||20.7|5.9|<0.001
91518978|NCT03492281|182912071|SUPERIORITY||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.7|5.8||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||5.8|1.7|<0.001
91518979|NCT03492281|182912071|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.13|=|0.0114|TWO_SIDED|95.0|0.6|5.1|||MMRM|||||5.1|0.6|=0.0114
91518980|NCT03492281|182912072|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.2|-4.6||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-4.6|-9.2|<0.0001
91518981|NCT03492281|182912072|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|-7.1|-2.2||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-2.2|-7.1|<0.001
91518982|NCT03492281|182912073|SUPERIORITY||Difference in percentage|12.4|||<|0.0001|TWO_SIDED|95.0|6.7|18.1||CMH=Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||18.1|6.7|<0.0001
91518983|NCT03492281|182912073|SUPERIORITY||Difference in percentage|6.9|||=|0.0236|TWO_SIDED|95.0|0.9|12.8|||Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||12.8|0.9|=0.0236
91518984|NCT03492281|182912074|SUPERIORITY||Difference in percentage|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.6|4.7|<0.001
91518985|NCT03492281|182912074|SUPERIORITY||Difference in percentage|11.5|||=|0.0022|TWO_SIDED|95.0|4.2|18.9|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.9|4.2|=0.0022
91518986|NCT03492281|182912075|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.1|-0.3|<0.0001
91518987|NCT03492281|182912075|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.0055|TWO_SIDED|95.0|-0.2|0.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||0.0|-0.2|=0.0055
91518988|NCT03492281|182912076|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-0.4|<0.0001
91518989|NCT03492281|182912076|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.3|<0.001
91518990|NCT01569438|182912117|OTHER||Mean Difference|-0.7||||0.0734|TWO_SIDED|90.0|-1.6|0.2||one-sided|Mixed Model with Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||0.2|-1.6|0.0734
91518991|NCT01569438|182912118|OTHER||Mean Difference|-1.0||||0.2726|TWO_SIDED|90.0|-3.9|1.8||one-sided|Mixed Model With Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||1.8|-3.9|0.2726
91518992|NCT01569438|182912119|OTHER||Mean Difference|-0.3||||0.3603|TWO_SIDED|90.0|-1.7|1.1||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||1.1|-1.7|0.3603
91518993|NCT01569438|182912120|OTHER||Mean Difference|-1.5||||0.1183|TWO_SIDED|90.0|-3.5|0.6||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||0.6|-3.5|0.1183
91518994|NCT00452387|182912122|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Fisher Exact|||The test of association of PSA and imaging response tests the null hypothesis that the proportion of cases exhibiting PSA response is the same for patients with and without a favorable imaging response. A 2x2 table was constructed based on the number of the patients in imaging response (favorable and unfavorable) and PSA response (\>50% reduction and \<=50% reduction). The Fisher's exact test was used to test this hypothesis.||||0.55
91518995|NCT00579280|182912128|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91518996|NCT00579280|182912129|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91518997|NCT00579280|182912130|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91518998|NCT00579280|182912131|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<.05
91518999|NCT00579280|182912132|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91519000|NCT00579280|182912133|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91519001|NCT00579280|182912134|SUPERIORITY||||||<|0.05|||||||Chi-squared|Differences in response (70% or greater improvement) and remission (50% or greater improvement) rates between the groups.||||||<0.05
91519002|NCT00579280|182912135|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91519003|NCT00579280|182912136|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91519004|NCT00579280|182912137|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91519005|NCT00579280|182912138|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91581606|NCT02349425|183053223|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.008|TWO_SIDED|95.0|-23.3|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-23.3|0.008
91581607|NCT02349425|183053223|SUPERIORITY||Mean Difference (Final Values)|-30.2|||<|0.001|TWO_SIDED|95.0|-44.7|-15.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-15.7|-44.7|<0.001
91519006|NCT01693068|182912139|OTHER|A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system \[IVRS\] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.|Hazard Ratio (HR)|0.59||||0.0022|TWO_SIDED|95.0|0.42|0.83|||Stratified Log Rank Test||The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.|||0.83|0.42|0.0022
91519007|NCT00617344|182912157|OTHER|The associated 95% confidence intervals (CIs) for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 1: Pre-injection 1 (Day 0)||2.84|-7.44|
91519008|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-15.5|||||TWO_SIDED|95.0|-28.4|-2.0||||||Dengue Virus Serotype 1: 30 days post-injection 2||-2.00|-28.4|
91519009|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 2: Pre-injection 1 (Day 0)||2.84|-7.44|
91519010|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-3.1|||||TWO_SIDED|95.0|-15.0|8.75||||||Dengue Virus Serotype 2: 30 days post-injection 2||8.75|-15.0|
91519011|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|1.0|||||TWO_SIDED|95.0|-9.09|11.1||||||Dengue Virus Serotype 3: Pre-injection 1 (Day 0)||11.1|-9.09|
91519012|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-5.7|||||TWO_SIDED|95.0|-15.6|3.81||||||Dengue Virus Serotype 3: 30 days post-injection 2||3.81|-15.6|
91519013|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-4.0|||||TWO_SIDED|95.0|-10.9|2.49||||||Dengue Virus Serotype 4: Pre-injection 1 (Day 0)||2.49|-10.9|
91519014|NCT00617344|182912157|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|31.4|||||TWO_SIDED|95.0|18.2|43.2||||||Dengue Virus Serotype 4: 30 days post-injection 2||43.2|18.2|
91519015|NCT01077830|182912198|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.84|2.09|||Regression, Cox||Hazard Ratio obtained by dividing the crude rate of death (any cause) reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death (any cause) in the Placebo arm|||2.09|0.84|
91519016|NCT01077830|182912199|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.3|6.06|||||Hazard Ratio obtained by dividing the crude rate of death from cancer reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death from cancer in the Placebo arm|||6.06|0.30|
91519017|NCT01077830|182912200|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.27|1.11|||||Hazard Ratio obtained by dividing the crude rate of new cancers reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of newly diagnosed cancers in the the Placebo arm|||1.11|0.27|
91519018|NCT01194570|182912203|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|29.337||||0.0404|TWO_SIDED|95.0|-1.618|51.456||P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL 25-FTW)\*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.||51.456|-1.618|0.0404
91519019|NCT01194570|182912204|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Geometric Means|0.9|||<|0.0001|TWO_SIDED|95.0|0.876|0.924||P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA|||Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL T2 lesion volume)\*Week.||0.924|0.876|< 0.0001
91519020|NCT01194570|182912205|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|17.475||||0.0206|TWO_SIDED|95.0|3.206|29.251|||MMRM||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Brain Volume at Week 24\*Week. Relative reduction was calculated as - Relative change = - (OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using Bootstrap method.||29.251|3.206|0.0206
91519021|NCT01194570|182912206|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.377|STANDARD_ERROR_OF_MEAN|0.725||0.6034|TWO_SIDED|95.0|-1.048|1.802|||MMRM||Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Baseline PCS Score\*Week.||1.802|-1.048|0.6034
91519022|NCT04171102|182912208|OTHER|||||||0.028||||||\<0.05|t-test, 2 sided|||||||0.028
91519023|NCT01751126|182912209|SUPERIORITY||LS Mean|0.76||||0.007|TWO_SIDED|95.0|0.26|1.27||ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).|t-test, 2 sided|||||1.27|0.26|0.007
91519024|NCT01751126|182912209|SUPERIORITY||LS Mean|0.67||||0.01|TWO_SIDED|95.0|0.16|1.18|||ANCOVA|ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).||||1.18|0.16|0.010
91519025|NCT00876915|182912214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.4795|TWO_SIDED|95.0|0.235|1.89|||stratified Cox|||||1.890|0.235|0.4795
91519026|NCT00876915|182912215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.019||||0.0252|TWO_SIDED|95.0|1.236|131.632|||stratified Cox|||||131.632|1.236|0.0252
91519027|NCT02673398|182912229|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.05|TWO_SIDED|95.0|-0.82|0.01|||t-test, 2 sided||Patients with higher risk scores were more likely to require a dose reduction. The lack of significance is most likely due to the small sample size.|Student's t-test was used to assess if geriatric risk score differed depending on whether or not a participant had a dose reduction (mean difference log2 risk = no dose modification - dose modification).||0.01|-0.82|0.05
91519028|NCT02673398|182912229|SUPERIORITY||Slope|-1.29|STANDARD_ERROR_OF_MEAN|1.44||0.39|TWO_SIDED||||||Regression, Linear|||Linear regression was used to assess whether log2 geriatric toxicity risk score was a risk factor for the number of course completed.||||0.39
91519029|NCT02673398|182912230|SUPERIORITY||Slope|-0.093|STANDARD_ERROR_OF_MEAN|0.0398||0.03|TWO_SIDED||||||Regression, Linear||The older the participant the lower the steady state value.|Least squares regression was used to assess the relationship between steady state neratinib concentration and age||||0.03
91519030|NCT02673398|182912230|SUPERIORITY||Slope|1.4|STANDARD_DEVIATION|2.39||0.57|TWO_SIDED||||||Regression, Linear||Geriatric risk score was not predictive of steady state concentration.|Least squares regression was used to determine if geriatric toxicity risk score at baseline was predictive of steady state neratinib concentration.||||0.57
91519031|NCT05616962|182912251|SUPERIORITY|||||||0.473|||||||ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||0.473
91519032|NCT05616962|182912252|SUPERIORITY|||||||0.03199|||||||paired t-test|||||||0.03199
91519033|NCT05616962|182912253|SUPERIORITY|||||||0.408|||||||ANCOVA|ANCOVA with baseline value as covariate||||||0.408
91581608|NCT02349425|183053223|SUPERIORITY||Mean Difference (Final Values)|-26.7||||0.001|TWO_SIDED|95.0|-42.3|-11.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.0|-42.3|0.001
91519034|NCT05616962|182912254|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519035|NCT05616962|182912255|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519036|NCT05616962|182912256|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519037|NCT05616962|182912257|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519038|NCT05616962|182912258|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519039|NCT05616962|182912259|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519040|NCT05616962|182912260|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519041|NCT05616962|182912261|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519042|NCT05616962|182912262|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519043|NCT05616962|182912263|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519044|NCT05616962|182912264|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519045|NCT05616962|182912265|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519046|NCT05616962|182912266|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519047|NCT05616962|182912267|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
91519048|NCT05616962|182912269|SUPERIORITY|||||||0.00463|||||||paired t-test|||||||0.00463
91519049|NCT05616962|182912270|SUPERIORITY|||||||0.23077|||||||paired t-test|||||||0.23077
91519050|NCT05616962|182912271|SUPERIORITY|||||||0.00849|||||||paired t-test|||||||0.00849
91519051|NCT00857207|182912289|SUPERIORITY||Mean Difference (Final Values)|-3.95|STANDARD_ERROR_OF_MEAN|1.14||0.0004|TWO_SIDED|95.0|||||Regression, Linear|dependent variable: post-treatment outcome; independent variables:pre-treatment measurement and group indicator.||Linear regression of change of cTOL time to first move in GMT versus BHW group||||0.0004
91519052|NCT00857207|182912289|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_DEVIATION|3.55||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||total time will significantly improve 10 weeks from post||||0.012
91519053|NCT00857207|182912289|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.04||0.98|TWO_SIDED|95.0|||||t-test, 2 sided|||Time to first move will significantly increase at 10 weeks from baseline to indicate better planning||||0.98
91519054|NCT00857207|182912290|SUPERIORITY||Mean Difference (Final Values)|2.64|STANDARD_DEVIATION|6.42||0.15|TWO_SIDED|95.0|||||t-test, 2 sided|||paired T-test, Behavioral Regulation Index will improve at week 10 from baseline||||0.15
91519055|NCT00857207|182912290|SUPERIORITY||Mean Difference (Final Values)|2.79|STANDARD_DEVIATION|8.4||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||paired t-test of Metacognitive Index, MI will improve at 10 weeks compared to baseline.||||0.24
91519056|NCT00857207|182912291|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|||||t-test, 2 sided|||optimal moves will significantly increase at 10 weeks from baseline||||0.30
91519057|NCT04098406|182912294|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.4304|TWO_SIDED|95.0|-11.9|27.3|||MMRM|||||27.3|-11.9|0.4304
91519058|NCT04098406|182912295|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.6519|TWO_SIDED|95.0|-12.4|19.7|||MMRM|||||19.7|-12.4|0.6519
91519059|NCT04098406|182912296|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.6158|TWO_SIDED|95.0|-56.4|94.0|||MMRM|||||94.0|-56.4|0.6158
91519060|NCT04098406|182912301|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.4249|TWO_SIDED|95.0|-1.6|3.6|||MMRM|||||3.6|-1.6|0.4249
91519061|NCT04098406|182912302|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.0350
91519062|NCT04098406|182912304|SUPERIORITY||Mean Difference (Final Values)|9.1||||0.2237|TWO_SIDED|95.0|-5.8|23.9|||ANCOVA|||||23.9|-5.8|0.2237
91519063|NCT04098406|182912305|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0125|TWO_SIDED|95.0|0.103|0.815|||Log Rank|||||0.815|0.103|0.0125
91519064|NCT04098406|182912307|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0177|TWO_SIDED|95.0|0.2|1.6|||MMRM|||||1.6|0.2|0.0177
91519065|NCT03014674|182912311|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.04|||||TWO_SIDED|90.0|0.98|1.11|||||Ratio (autoinjector/lyophilized drug) for Cmax has been presented|||1.11|0.98|
91519066|NCT03014674|182912311|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.06|||||TWO_SIDED|90.0|0.99|1.12|||||Ratio (safety syringe/lyophilized drug) for Cmax has been presented|||1.12|0.99|
91519067|NCT03014674|182912312|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)|Ratio|1.08|||||TWO_SIDED|90.0|1.01|1.15|||||Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented|||1.15|1.01|
91519068|NCT03014674|182912312|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).|Ratio|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented|||1.12|0.97|
91519069|NCT03014674|182912312|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.07|||||TWO_SIDED|90.0|1.0|1.13|||||Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented|||1.13|1.00|
91706821|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|24.1|||||TWO_SIDED|95.0|20.6|27.6||||||Difference in HI Titers ≥ 1:629 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||27.6|20.6|
91519070|NCT03014674|182912312|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.02|||||TWO_SIDED|90.0|0.95|1.09|||||Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented|||1.09|0.95|
91519071|NCT03382782|182912380|SUPERIORITY||Mean Difference (Net)|0.36||||0.025|TWO_SIDED||||||ANOVA|degrees of freedom = (3, 172)||||||.025
91519072|NCT03382782|182912381|SUPERIORITY||Mean Difference (Net)|0.243||||0.784|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.784
91519073|NCT03382782|182912381|SUPERIORITY||Mean Difference (Net)|0.058||||0.81|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.810
91519074|NCT03382782|182912382|SUPERIORITY||Mean Difference (Net)|1.77||||0.174|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.174
91519075|NCT03382782|182912382|SUPERIORITY||Mean Difference (Net)|1.15||||0.286|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.286
91519076|NCT03382782|182912383|SUPERIORITY||Mean Difference (Net)|1.36||||0.261|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.261
91519077|NCT03382782|182912383|SUPERIORITY||Mean Difference (Net)|0.012||||0.912|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.912
91519078|NCT03382782|182912385|SUPERIORITY||Mean Difference (Net)|1.74||||0.11|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 172||||||0.11
91519079|NCT03382782|182912386|SUPERIORITY||Mean Difference (Net)|1.18||||0.09|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean systolic blood pressure||||0.09
91519080|NCT03382782|182912386|SUPERIORITY||Mean Difference (Net)|0.63||||0.05|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean diastolic blood pressure||||0.05
91519081|NCT03382782|182912388|SUPERIORITY|Intention-to-treat analyses. General Health subscale.|Mean Difference (Net)|2.14||||0.121|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||||||0.121
91519082|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|1.71||||0.193|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses. General Health subscale.||||0.193
91519083|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|0.181||||0.835|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Bodily Pain subscale.||||0.835
91519084|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|0.43||||0.513|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Bodily Pain subscale.||||0.513
91519085|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|2.37||||0.097|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses, Physical Functioning subscale.||||0.097
91519086|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|0.04||||0.184|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Physical Functioning subscale.||||0.184
91519087|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|1.06||||0.347|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Emotional Well-Being subscale.||||0.347
91519088|NCT03382782|182912388|SUPERIORITY||Mean Difference (Net)|0.361||||0.549|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Emotional Well-Being subscale.||||0.549
91519089|NCT03382782|182912389|SUPERIORITY||Mean Difference (Net)|0.157||||0.855|TWO_SIDED||||||ANOVA|Degrees of freedom = 2,182||Intention-to-treat analyses||||.855
91519090|NCT03382782|182912389|SUPERIORITY||Mean Difference (Net)|0.011||||0.915|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.915
91519091|NCT03382782|182912391|SUPERIORITY||Mean Difference (Net)|0.68||||0.508|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.508
91519092|NCT03382782|182912391|SUPERIORITY||Mean Difference (Net)|1.67||||0.198|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.198
91519093|NCT01316510|182912393|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Primary outcome (percentage of bifidobacteria in the final stool specimen)||||<0.01
91519094|NCT01316510|182912394|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)||||0.44
91519095|NCT00428090|182912399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.074|TWO_SIDED|95.0|-3.8|0.2||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.8|0.074
91519096|NCT00428090|182912399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.338|TWO_SIDED|95.0|-3.0|1.0||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.0|-3.0|0.338
91519097|NCT00428090|182912399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.602|TWO_SIDED|95.0|-3.5|2.1||Comparison between Placebo and Donepezil 10mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-3.5|0.602
91519098|NCT00428090|182912400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.131|TWO_SIDED|95.0|-2.7|0.4||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.7|0.131
91519099|NCT00428090|182912400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.315|TWO_SIDED|95.0|-2.4|0.8||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.8|-2.4|0.315
91519100|NCT00428090|182912400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.105|TWO_SIDED|95.0|-3.5|0.3||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-3.5|0.105
91519101|NCT00428090|182912401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
91519102|NCT00428090|182912401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
91519103|NCT00428090|182912401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.4|-3.1|0.131
91519104|NCT00428090|182912402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.663|TWO_SIDED|95.0|-0.3|0.4||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-0.3|0.663
91519105|NCT00428090|182912402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.3||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.4|0.891
91519106|NCT00428090|182912402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.414|TWO_SIDED|95.0|-0.7|0.3||Comparison between Placebo and Donepezil 10 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||0.3|-0.7|0.414
91519107|NCT00428090|182912403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.3|0.3||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.3|-0.3|0.913
91706822|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|4.5|7.5||||||Difference in HI Titers ≥ 1:110 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||7.5|4.5|
91519108|NCT00428090|182912403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.276|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.276
91519109|NCT00428090|182912403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.025
91519110|NCT00428090|182912404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
91519111|NCT00428090|182912404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
91519112|NCT00428090|182912404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
91519113|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.116|TWO_SIDED|95.0|-2.0|0.2||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-2.0|0.116
91519114|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.816|TWO_SIDED|95.0|-0.9|1.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.9|0.816
91519115|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.1|0.318
91519116|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.839|TWO_SIDED|95.0|-1.1|1.3||Comparison between Placebo and RSG XR 2 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.3|-1.1|0.839
91519117|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.165|TWO_SIDED|95.0|-0.3|2.0||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.0|-0.3|0.165
91519118|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.073|TWO_SIDED|95.0|-3.4|0.2||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.4|0.073
91519119|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
91519120|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
91519121|NCT00428090|182912405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-3.1|0.131
91581609|NCT02349425|183053224|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-23.5|<0.001
91706823|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.6||||||Difference in HI Titers ≥ 1:151 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.6|6.1|
91519122|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.133|TWO_SIDED|95.0|-0.3|0.0||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.3|0.133
91519123|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.2|0.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.2|0.958
91519124|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.085|TWO_SIDED|95.0|-0.5|0.0||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.5|0.085
91519125|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.102|TWO_SIDED|95.0|-0.4|0.0||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.4|0.102
91519126|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.3|0.380
91519127|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.006|TWO_SIDED|95.0|-0.7|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.7|0.006
91519128|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
91519129|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
91519130|NCT00428090|182912406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
91519131|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.957|TWO_SIDED|95.0|-1.6|1.5||Comparison between Placebo and RSG XR 2mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.5|-1.6|0.957
91519132|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.693|TWO_SIDED|95.0|-1.4|2.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-1.4|0.693
91519133|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.798|TWO_SIDED|95.0|-2.2|1.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.7|-2.2|0.798
91519134|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-1.7|1.8||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|-1.7|0.958
91519135|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-2.1|2.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-2.1|0.998
91519136|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.639||95.0|-1.7|2.8||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-1.7|0.639
91581610|NCT02349425|183053224|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.1|-7.4|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.4|-26.1|<0.001
91519137|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.797|TWO_SIDED|95.0|-2.1|2.7||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.1|0.797
91519138|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.942|TWO_SIDED|95.0|-2.9|2.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.9|0.942
91519139|NCT00428090|182912407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.213|TWO_SIDED|95.0|-4.8|1.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-4.8|0.213
91519140|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.919|TWO_SIDED|95.0|-2.1|2.3||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.3|-2.1|0.919
91519141|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.649|TWO_SIDED|95.0|-1.5|2.4||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.4|-1.5|0.649
91519142|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.279|TWO_SIDED|95.0|-1.1|3.6||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.1|0.279
91519143|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.498|TWO_SIDED|95.0|-1.8|3.6||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.8|0.498
91581611|NCT02349425|183053224|SUPERIORITY||Mean Difference (Final Values)|-19.5||||0.002|TWO_SIDED|95.0|-31.1|-7.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.8|-31.1|0.002
91519144|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.489|TWO_SIDED|95.0|-1.7|3.6||Comparison between Placebo and RSG XR 8 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.7|0.489
91519145|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.024|TWO_SIDED|95.0|0.5|7.0||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.0|0.5|0.024
91519146|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.385|TWO_SIDED|95.0|-1.6|4.2||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||4.2|-1.6|0.385
91519147|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.944|TWO_SIDED|95.0|-3.0|2.8||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-3.0|0.944
91519148|NCT00428090|182912408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.078|TWO_SIDED|95.0|-0.4|7.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.5|-0.4|0.078
91519149|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.635|TWO_SIDED|95.0|-0.8|0.5||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-0.8|0.635
91519150|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.194|TWO_SIDED|95.0|-0.2|1.1||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-0.2|0.194
91519151|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.325|TWO_SIDED|95.0|-1.3|0.4||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-1.3|0.325
91519152|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.109|TWO_SIDED|95.0|-0.1|1.2||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.1|0.109
91519153|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.032|TWO_SIDED|95.0|0.1|1.4||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|0.1|0.032
91519154|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.189|TWO_SIDED|95.0|-1.7|0.3||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.7|0.189
91519155|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.288|TWO_SIDED|95.0|-1.1|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.1|0.288
91519156|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.819|TWO_SIDED|95.0|-0.8|0.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.819
91519157|NCT00428090|182912409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.306|TWO_SIDED|95.0|-1.5|0.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.5|0.306
91519158|NCT00428090|182912410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.199|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.199
91581612|NCT02349425|183053224|SUPERIORITY||Mean Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-31.8|-9.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.3|-31.8|<0.001
91581613|NCT02349425|183053225|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.315|TWO_SIDED|95.0|-12.3|4.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.0|-12.3|0.315
91644167|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.437|||<|0.0001|TWO_SIDED|95.0|3.306|3.568|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)||3.568|3.306|<.0001
91644168|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)||-0.262|-0.660|<.0001
91644169|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.462|||<|0.0001|TWO_SIDED|95.0|-0.679|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.679|<.0001
91644170|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.433|||<|0.0001|TWO_SIDED|95.0|-0.633|-0.233|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)||-0.233|-0.633|<.0001
91644171|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.678|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.678|<.0001
91644172|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.928|||<|0.0001|TWO_SIDED|95.0|-2.154|-1.701|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)||-1.701|-2.154|<.0001
91644173|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.089|||<|0.0001|TWO_SIDED|95.0|-2.336|-1.842|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)||-1.842|-2.336|<.0001
91644174|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.879|||<|0.0001|TWO_SIDED|95.0|-2.102|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)||-1.656|-2.102|<.0001
91706824|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|11.7|||||TWO_SIDED|95.0|9.6|13.9||||||Difference in HI Titers ≥ 1:215 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||13.9|9.6|
91706825|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|19.0|||||TWO_SIDED|95.0|16.1|22.0||||||Difference in HI Titers ≥ 1:330 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||22.0|16.1|
91706826|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|21.1|||||TWO_SIDED|95.0|17.8|24.3||||||Difference in HI Titers ≥ 1:629 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||24.3|17.8|
91706827|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|28.8|||||TWO_SIDED|95.0|25.1|32.3||||||Difference in HI Titers ≥ 1:110 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||32.3|25.1|
91706828|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|26.3|||||TWO_SIDED|95.0|22.6|29.9||||||Difference in HI Titers ≥ 1:151 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||29.9|22.6|
91519159|NCT00428090|182912410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.08||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.08|-0.01|0.094
91519160|NCT00428090|182912410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.187|TWO_SIDED|95.0|-0.02|0.09||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.09|-0.02|0.187
91519161|NCT00428090|182912410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.134|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.134
91519162|NCT00428090|182912410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.05|0.05||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.05|-0.05|0.958
91519163|NCT00428090|182912410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.374|TWO_SIDED|95.0|-0.03|0.07||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.03|0.374
91519164|NCT00428090|182912411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.493|TWO_SIDED|95.0|-4.6|2.2||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-4.6|0.493
91519165|NCT00428090|182912411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.883|TWO_SIDED|95.0|-3.2|3.7||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.7|-3.2|0.883
91519166|NCT00428090|182912411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.13|TWO_SIDED|95.0|-9.3|1.2||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-9.3|0.130
91519167|NCT00428090|182912411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.198|TWO_SIDED|95.0|-6.6|1.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|-6.6|0.198
91519168|NCT00428090|182912411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.441|TWO_SIDED|95.0|-5.9|2.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.6|-5.9|0.441
91519169|NCT00428090|182912411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.898|TWO_SIDED|95.0|-5.8|5.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||5.1|-5.8|0.898
91519170|NCT00428090|182912413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.027|TWO_SIDED|95.0|-2.1|-0.1||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-2.1|0.027
91519171|NCT00428090|182912413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.278|TWO_SIDED|95.0|-1.6|0.5||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.6|0.278
91519172|NCT00428090|182912413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-1.2|1.1||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-1.2|0.993
91519173|NCT00428090|182912413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.196|TWO_SIDED|95.0|-2.0|0.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.0|0.196
91519174|NCT00428090|182912413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.353|TWO_SIDED|95.0|-1.9|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-1.9|0.353
91519175|NCT00428090|182912413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.427|TWO_SIDED|95.0|-2.2|0.9||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.9|-2.2|0.427
91581614|NCT02349425|183053225|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.03|TWO_SIDED|95.0|-13.7|-0.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.7|-13.7|0.030
91644175|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.017|||<|0.0001|TWO_SIDED|95.0|-2.262|-1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)||-1.772|-2.262|<.0001
91644176|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.465|||<|0.0001|TWO_SIDED|95.0|1.25|1.679|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)||1.679|1.250|<.0001
91644177|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.537|||<|0.0001|TWO_SIDED|95.0|1.303|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.303|<.0001
91644178|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.492|||<|0.0001|TWO_SIDED|95.0|1.277|1.707|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)||1.707|1.277|<.0001
91644179|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.538|||<|0.0001|TWO_SIDED|95.0|1.304|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.304|<.0001
91644180|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|-0.003||||1|TWO_SIDED|95.0|-0.242|0.237|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)||0.237|-0.242|1.0000
91644181|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.09||||0.9399|TWO_SIDED|95.0|-0.351|0.172|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)||0.172|-0.351|0.9399
91644182|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|0.047||||0.9993|TWO_SIDED|95.0|-0.19|0.283|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)||0.283|-0.190|0.9993
91644183|NCT03692078|183180087|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.018||||1|TWO_SIDED|95.0|-0.278|0.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)||0.242|-0.278|1.0000
91644184|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.805|||<|0.0001|TWO_SIDED|95.0|1.639|1.971|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.971|1.639|<.0001
91644185|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.788|||<|0.0001|TWO_SIDED|95.0|1.622|1.954|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.954|1.622|<.0001
91644186|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.29|||<|0.0001|TWO_SIDED|95.0|1.145|1.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.462|1.145|<.0001
91644187|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.304|||<|0.0001|TWO_SIDED|95.0|1.134|1.447|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.447|1.134|<.0001
91644188|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.353|||<|0.0001|TWO_SIDED|95.0|1.194|1.513|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.513|1.194|<.0001
91644189|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.313|||<|0.0001|TWO_SIDED|95.0|1.153|1.472|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.472|1.153|<.0001
91644190|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.956|||<|0.0001|TWO_SIDED|95.0|-1.155|-0.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-0.756|-1.155|<.0001
91706829|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|18.3|25.3||||||Difference in HI Titers ≥ 1:215 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||25.3|18.3|
91519176|NCT00428090|182912414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.886|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.7|0.886
91519177|NCT00428090|182912414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.71|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.710
91519178|NCT00428090|182912414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03|TWO_SIDED|95.0|0.1|1.8|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|0.1|0.030
91519179|NCT00428090|182912415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.139|TWO_SIDED|95.0|0.0|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.0|0.139
91706830|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|8.6|14.5||||||Difference in HI Titers ≥ 1:330 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||14.5|8.6|
91644191|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.315|-0.913|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-0.913|-1.315|<.0001
91644192|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.999|||<|0.0001|TWO_SIDED|95.0|-1.195|-0.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-0.803|-1.195|<.0001
91644193|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.164|||<|0.0001|TWO_SIDED|95.0|-1.364|-0.964|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-0.964|-1.364|<.0001
91644194|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.775|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.582|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.582|-0.969|<.0001
91644195|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.795|||<|0.0001|TWO_SIDED|95.0|-0.99|-0.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.600|-0.990|<.0001
91644196|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.514||||0.0002|TWO_SIDED|95.0|-0.836|-0.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.193|-0.836|0.0002
91644197|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.484||||0.0005|TWO_SIDED|95.0|-0.808|-0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.160|-0.808|0.0005
91644198|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.452||||0.0014|TWO_SIDED|95.0|-0.775|-0.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.128|-0.775|0.0014
91706831|NCT01964989|183307735|OTHER||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|4.3|9.4||||||Difference in HI Titers ≥ 1:629 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.4|4.3|
91706832|NCT02769312|183307746|OTHER||Effect size (cohen's d)|0.16||||0.46|TWO_SIDED||||||ANCOVA|||||||0.46
91706833|NCT02769312|183307747|SUPERIORITY||Effect size (cohen's d)|0.12||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
91706834|NCT02769312|183307748|SUPERIORITY||Effect size (cohen's d)|0.39||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
91581615|NCT02349425|183053225|SUPERIORITY||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-27.4|-9.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.1|-27.4|<0.001
91706835|NCT01579669|183307752|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||t-test, 2 sided|||Pre-post comparison||||0.0269
91706836|NCT01579669|183307753|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||<0.0001
91706837|NCT01579669|183307754|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||0.016
91644199|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.475||||0.0007|TWO_SIDED|95.0|-0.799|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.799|0.0007
91644200|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.127|-2.394|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.394|-3.127|<.0001
91644201|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.902|||<|0.0001|TWO_SIDED|95.0|-3.271|-2.533|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.533|-3.271|<.0001
91644202|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.804|||<|0.0001|TWO_SIDED|95.0|-3.165|-2.443|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.443|-3.165|<.0001
91644203|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.952|||<|0.0001|TWO_SIDED|95.0|-3.317|-2.587|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.587|-3.317|<.0001
91644204|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.066|||<|0.0001|TWO_SIDED|95.0|1.719|2.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.413|1.719|<.0001
91644205|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.099|||<|0.0001|TWO_SIDED|95.0|1.748|2.449|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.449|1.748|<.0001
91644206|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.129|||<|0.0001|TWO_SIDED|95.0|1.779|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.779|<.0001
91771784|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0533|TWO_SIDED|95.0|0.99|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.59|0.99|0.0533
91519180|NCT00428090|182912415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.846|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.1|0.846
91581616|NCT02349425|183053225|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-26.3|-9.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.0|-26.3|<0.001
91644207|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.107|||<|0.0001|TWO_SIDED|95.0|1.756|2.459|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.459|1.756|<.0001
91644208|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.18||||0.7678|TWO_SIDED|95.0|-0.569|0.209|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.209|-0.569|0.7678
91644209|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.319||||0.1691|TWO_SIDED|95.0|-0.711|0.073|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.073|-0.711|0.1691
91644210|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5178|TWO_SIDED|95.0|-0.606|0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.158|-0.606|0.5178
91644211|NCT03692078|183180089|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.369||||0.0699|TWO_SIDED|95.0|-0.757|0.018|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.018|-0.757|0.0699
91706838|NCT02131233|183307790|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|0.51|||||TWO_SIDED|95.0|-4.204|5.223|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||5.223|-4.204|
91519181|NCT00428090|182912415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.1|0.864
91519182|NCT00361140|182912435|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Chi-squared|||||||.007
91519183|NCT00361140|182912436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.27||||0.07|TWO_SIDED|95.0|0.92|42.48|||Gray|Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.||Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)||42.48|0.92|.07
91519184|NCT02623322|182912443|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
91519185|NCT02623322|182912443|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
91519186|NCT02623322|182912444|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
91519187|NCT02623322|182912444|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
91519188|NCT02623322|182912448|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7858|TWO_SIDED|80.0|0.62|1.37|||Wilcoxon|||Total Symptom Score of \<=1||1.37|0.62|0.7858
91519189|NCT02623322|182912448|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.517|TWO_SIDED|80.0|0.59|1.36|||Wilcoxon|||Total Symptom Score of \<=1||1.36|0.59|0.5170
91519190|NCT02623322|182912448|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0312|TWO_SIDED|80.0|0.45|0.89|||Wilcoxon|||Total Symptom Score of \<=7||0.89|0.45|0.0312
91519191|NCT02623322|182912448|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2044|TWO_SIDED|80.0|0.53|1.04|||Wilcoxon|||Total Symptom Score of \<=7||1.04|0.53|0.2044
91519192|NCT02450331|182912468|SUPERIORITY||Hazard Ratio (HR)|0.892||||0.2446|TWO_SIDED|95.0|0.735|1.081|||Log Rank|||||1.081|0.735|0.2446
91644212|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.177|||<|0.0001|TWO_SIDED|95.0|6.062|6.292|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||6.292|6.062|<.0001
91644213|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.197|||<|0.0001|TWO_SIDED|95.0|6.082|6.312|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||6.312|6.082|<.0001
91644214|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.798|||<|0.0001|TWO_SIDED|95.0|5.69|5.906|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.906|5.690|<.0001
91644215|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.82|||<|0.0001|TWO_SIDED|95.0|5.71|5.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.930|5.710|<.0001
91644216|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.863|||<|0.0001|TWO_SIDED|95.0|5.753|5.974|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.974|5.753|<.0001
91644217|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.816|||<|0.0001|TWO_SIDED|95.0|5.706|5.927|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.927|5.706|<.0001
91519193|NCT02450331|182912469|SUPERIORITY||Hazard Ratio (HR)|0.897||||0.3172|TWO_SIDED|95.0|0.726|1.109|||Log Rank|||Stratified analysis based on PDL1 status, tumor stage after resection, and nodal status.||1.109|0.726|0.3172
91519194|NCT02450331|182912470|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.836||||0.2235|TWO_SIDED|95.0|0.626|1.116|||Log Rank|||||1.116|0.626|0.2235
91519195|NCT02450331|182912471|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.918||||0.4291|TWO_SIDED|95.0|0.743|1.134|||Log Rank|||||1.134|0.743|0.4291
91519196|NCT02450331|182912472|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.879||||0.1994|TWO_SIDED|95.0|0.722|1.07|||Log Rank|||||1.070|0.722|0.1994
91519197|NCT02080871|182912478|OTHER|This was a single-arm study designed to compare the primary outcome result to a performance goal based on published literature. The null hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of study device is at least 17%. The alternate hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of the study device is less than 17%.|||||<|0.001|||||||one-sided binomial exact test|||The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.||||<0.001
91519198|NCT03384173|182912575|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91519199|NCT03384173|182912576|OTHER|Correlation, Pearson r|Pearson r correlation|0.16||||0.17|TWO_SIDED|95.0|-0.07|0.37|||Pearson r correlation|||||0.37|-0.07|0.17
91519200|NCT03384173|182912577|OTHER|Correlation, Pearson r|Pearson r correlation|0.12||||0.32|TWO_SIDED|95.0|-0.11|0.33|||Pearson r correlation|||||0.33|-0.11|0.32
91519201|NCT03384173|182912579|OTHER|Mann Whitney U non parametric test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup 30-39.99%' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Control group is Secondary analysis #4, baseline values before caffeine dose.||||<0.01
91519202|NCT03384173|182912580|OTHER|Mann Whitney U non parametric test|||||<|0.001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Control group is secondary outcome #4, baseline values before caffeine dose||||<0.001
91644218|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.947|||<|0.0001|TWO_SIDED|95.0|4.809|5.084|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||5.084|4.809|<.0001
91644219|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.913|||<|0.0001|TWO_SIDED|95.0|4.774|5.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.052|4.774|<.0001
91644220|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.862|||<|0.0001|TWO_SIDED|95.0|4.727|4.998|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.998|4.727|<.0001
91644221|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.938|||<|0.0001|TWO_SIDED|95.0|4.799|5.076|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||5.076|4.799|<.0001
91644222|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.826|||<|0.0001|TWO_SIDED|95.0|4.693|4.959|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.959|4.693|<.0001
91644223|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.902|||<|0.0001|TWO_SIDED|95.0|4.767|5.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||5.037|4.767|<.0001
91710564|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.74|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|90.0|2.45|5.02|||t-test, 2 sided|||FEV1/FVC Day 8 (0.25 hrs post-dose)||5.02|2.45|<0.0001
91519203|NCT03384173|182912581|OTHER|Mann-Whitney U non parametric t test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup \>60% ' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary outcome #4, baseline caffeine values by subgroup||||<0.01
91519204|NCT03384173|182912582|OTHER||||||<|0.0001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is secondary outcome #4, baseline values before caffeine dose||||<0.0001
91519205|NCT03384173|182912583|OTHER|Mann Whitney U non-parametric t-test|||||<|0.05||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary Outcome #4, baseline before dose of caffeine.||||<0.05
91519206|NCT03148470|182912584|OTHER|||||||0.932||||||This p-value refers to the effect of stimulation (cTBS vs iTBS).|Mixed Models Analysis|||||||0.932
91519207|NCT03148470|182912585|OTHER|||||||0.642|||||||Mixed Models Analysis|||||||0.642
91519208|NCT04493931|182912586|OTHER||Ratio of Geometric LS Mean|0.944|||||TWO_SIDED|90.0|0.753|1.184||||||||1.184|0.753|
91519209|NCT04493931|182912587|OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.75|0.742|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.742|-0.750|
91519210|NCT04493931|182912588|OTHER||Ratio of Geometric LS Mean|1.094|||||TWO_SIDED|90.0|0.959|1.249||||||||1.249|0.959|
91519211|NCT04493931|182912589|OTHER||Ratio of Geometric LS Mean|1.157|||||TWO_SIDED|90.0|1.059|1.265||||||||1.265|1.059|
91519212|NCT04493931|182912590|OTHER||Ratio of Geometric LS Mean|1.158|||||TWO_SIDED|90.0|1.062|1.264||||||||1.264|1.062|
91519213|NCT04493931|182912591|OTHER||Ratio of Geometric LS Mean|0.73|||||TWO_SIDED|90.0|0.635|0.84||||||||0.840|0.635|
91519214|NCT04493931|182912592|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
91519215|NCT04493931|182912593|OTHER||Median Difference (Final Values)|-0.467|||||TWO_SIDED|90.0|-1.0|0.492|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate|||0.492|-1.000|
91519216|NCT04493931|182912594|OTHER||Ratio of Geometric LS Mean|0.476|||||TWO_SIDED|90.0|0.433|0.525||||||||0.525|0.433|
91644224|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.379|||<|0.0001|TWO_SIDED|95.0|-0.602|-0.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.156|-0.602|<.0001
91519217|NCT04493931|182912595|OTHER||Ratio of Geometric LS Mean|0.478|||||TWO_SIDED|90.0|0.435|0.526||||||||0.526|0.435|
91519218|NCT04493931|182912596|OTHER||Ratio of Geometric LS mean|1.533|||||TWO_SIDED|90.0|1.274|1.845||||||||1.845|1.274|
91519219|NCT04493931|182912597|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
91519220|NCT04493931|182912598|OTHER||Median Difference (Final Values)|-0.5|||||TWO_SIDED|90.0|-1.0|-0.233|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||-0.233|-1.000|
91519221|NCT04493931|182912599|OTHER||Ratio of Geometric LS mean|1.217|||||TWO_SIDED|90.0|1.085|1.363||||||||1.363|1.085|
91519222|NCT04493931|182912600|OTHER||Ratio of Geometric LS mean|1.121|||||TWO_SIDED|90.0|0.983|1.278||||||||1.278|0.983|
91519223|NCT04493931|182912601|OTHER||Ratio of Geometric LS mean|1.242|||||TWO_SIDED|90.0|1.046|1.475||||||||1.475|1.046|
91519224|NCT04493931|182912602|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
91519225|NCT04493931|182912603|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.8|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.800|-0.250|
91519226|NCT04493931|182912604|OTHER||Ratio of Geometric LS mean|1.923|||||TWO_SIDED|90.0|1.622|2.278||||||||2.278|1.622|
91519227|NCT04493931|182912605|OTHER||Ratio of Geometric LS mean|1.902|||||TWO_SIDED|90.0|1.619|2.234||||||||2.234|1.619|
91519228|NCT04493931|182912629|OTHER||Ratio of geometric LS mean|1.051|||||TWO_SIDED|90.0|0.824|1.34||||||||1.340|0.824|
91519229|NCT04493931|182912630|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.250|0.000|
91519230|NCT04493931|182912631|OTHER||Median Difference (Final Values)|0.5|||||TWO_SIDED|90.0|-0.5|1.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||1.250|-0.500|
91519231|NCT04493931|182912632|OTHER||Ratio of geometric LS mean|1.094|||||TWO_SIDED|90.0|0.987|1.212||||||||1.212|0.987|
91519232|NCT04493931|182912633|OTHER||Ratio of geometric LS mean|1.095|||||TWO_SIDED|90.0|0.991|1.209||||||||1.209|0.991|
91519233|NCT04493931|182912636|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|-0.250|
91519234|NCT04493931|182912639|OTHER||Ratio of geometric LS mean|1.214|||||TWO_SIDED|90.0|1.0|1.473||||||||1.473|1.000|
91519235|NCT04493931|182912640|OTHER||Ratio of geometric LS mean|1.097|||||TWO_SIDED|90.0|0.948|1.27||||||||1.270|0.948|
91519236|NCT04493931|182912641|OTHER||Ratio of geometric LS mean|1.071|||||TWO_SIDED|90.0|0.939|1.221||||||||1.221|0.939|
91519237|NCT04493931|182912642|OTHER||Ratio of geometric LS mean|1.096|||||TWO_SIDED|90.0|0.93|1.292||||||||1.292|0.930|
91519238|NCT04493931|182912656|OTHER||Ratio of geometric LS mean|0.499|||||TWO_SIDED|90.0|0.441|0.565||||||||0.565|0.441|
91519239|NCT04493931|182912657|OTHER||Ratio of geometric LS mean|0.439|||||TWO_SIDED|90.0|0.37|0.521||||||||0.521|0.370|
91519240|NCT04493931|182912658|OTHER||Ratio of geometric LS mean|0.438|||||TWO_SIDED|90.0|0.372|0.516||||||||0.516|0.372|
91519241|NCT04493931|182912659|OTHER||Ratio of geometric LS mean|1.036|||||TWO_SIDED|90.0|0.95|1.129||||||||1.129|0.950|
91519242|NCT04493931|182912683|OTHER||Ratio of Geometric LS mean|1.755|||||TWO_SIDED|90.0|1.304|2.363||||||||2.363|1.304|
91519243|NCT04493931|182912684|OTHER||Ratio of Geometric LS mean|0.833|||||TWO_SIDED|90.0|0.769|0.902||||||||0.902|0.769|
91519244|NCT04493931|182912685|OTHER||Ratio of Geometric LS mean|0.745|||||TWO_SIDED|90.0|0.653|0.85||||||||0.850|0.653|
91519245|NCT04493931|182912686|OTHER||Ratio of Geometric LS mean|0.892|||||TWO_SIDED|90.0|0.782|1.018||||||||1.018|0.782|
91519246|NCT04493931|182912687|OTHER||Ratio of Geometric LS mean|1.157|||||TWO_SIDED|90.0|0.876|1.528||||||||1.528|0.876|
91519247|NCT04493931|182912688|OTHER||Ratio of Geometric LS mean|1.142|||||TWO_SIDED|90.0|1.016|1.283||||||||1.283|1.016|
91519248|NCT04493931|182912689|OTHER||Ratio of Geometric LS mean|0.603|||||TWO_SIDED|90.0|0.521|0.699||||||||0.699|0.521|
91519249|NCT04493931|182912690|OTHER||Ratio of Geometric LS mean|0.526|||||TWO_SIDED|90.0|0.448|0.618||||||||0.618|0.448|
91519250|NCT00420199|182912732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-0.5|||||TWO_SIDED|95.0|-1.77|0.76|||ANCOVA|||Comparison in the change from baseline of erosion score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||0.76|-1.77|
91519251|NCT00420199|182912733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.103||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging score method between abatacept and placebo at Day 113 based on a nonparametric analysis of covariance model. Baseline and changes from baseline of the total wrist synovitis scores were ranked, and the model included the rank score for change from baseline as the dependent variable with treatment group as a main effect and the rank score for baseline as an additional covariate.||||0.103
91519252|NCT00420199|182912735|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-3.48|||||TWO_SIDED|95.0|-6.0|-0.96|||ANCOVA|||Comparison in the change from baseline of Edema/Osteitis score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-0.96|-6.00|
91519253|NCT00420199|182912738|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-4.71|||||TWO_SIDED|95.0|-8.0|-1.42|||ANCOVA|||Comparison in the change from baseline of RAMRIS score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-1.42|-8.00|
91519254|NCT00420199|182912752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.078||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging (MRI) score method between ABA and PLA at Day 113 based on a parametric analysis of covariance model (ANCOVA). The model included the score change from baseline as the dependent variable, treatment group as a main effect and baseline score as an additional covariate.||||0.078
91519255|NCT00558428|182912762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-4.9|-2.38|||ANCOVA|Adjusted for baseline and country effect||||-2.38|-4.90|<0.0001
91519256|NCT00558428|182912762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.92|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-6.18|-3.66|||ANCOVA|Adjusted for baseline and country effect||||-3.66|-6.18|<0.0001
91706839|NCT02131233|183307791|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|1.449|||||TWO_SIDED|95.0|-4.41|7.308|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||7.308|-4.410|
91519257|NCT00558428|182912762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.66|-0.14|||ANCOVA|Adjusted for baseline and country effect||||-0.14|-2.66|
91519258|NCT00558428|182912762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-3.93|-1.43|||ANCOVA|Adjusted for baseline and country effect||||-1.43|-3.93|
91519259|NCT00831779|182912793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.97|STANDARD_ERROR_OF_MEAN|7.4685||0.0059|TWO_SIDED|95.0|5.75|36.1||Primary endpoint was tested at alpha=0.05|ANOVA|||||36.10|5.75|0.0059
91519260|NCT00831779|182912794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.13|STANDARD_ERROR_OF_MEAN|14.4984||0.0598|TWO_SIDED|95.0|-1.22|57.48||Secondary endpoint was tested following a sequential testing procedure at alpha=0.05|ANOVA|||||57.48|-1.22|0.0598
91519261|NCT04020341|182912795|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the Z-statistic boundary (2.065).|Adjusted Difference in Percent|4.3|||||TWO_SIDED|95.0|-3.6|12.1|||||||Observed Z statistic value for Noninferiority was 3.5554.|12.1|-3.6|
91519262|NCT04020341|182912795|SUPERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.019 p-value boundary.|Adjusted difference of Percent|4.3||||0.1445|TWO_SIDED|95.0|-3.6|12.1|||1-sided p-value for Test of Superiority|||||12.1|-3.6|0.1445
91519263|NCT01814371|182912846|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.757|||||||Fisher Exact|||||||0.757
91519264|NCT01814371|182912847|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
91519265|NCT01814371|182912848|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.687|||||||Fisher Exact|||||||0.687
91519266|NCT01814371|182912849|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
91519267|NCT01814371|182912850|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.811|||||||Fisher Exact|||||||0.811
91519268|NCT01814371|182912851|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.004|||||||Fisher Exact|||||||0.004
91706840|NCT02131233|183307792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-30.9|26.7|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||26.7|-30.9|
91519269|NCT01814371|182912852|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.006|||||||Fisher Exact|||||||0.006
91519270|NCT01814371|182912853|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.05|||||||Fisher Exact|||||||0.050
91519271|NCT01814371|182912854|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.007|||||||Fisher Exact|||||||0.007
91519272|NCT01814371|182912855|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.005|||||||Fisher Exact|||||||0.005
91519273|NCT01814371|182912856|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
91519274|NCT01814371|182912857|EQUIVALENCE|testing equivalence of before and after decolonization protocol.||||||0.84|||||||Chi-squared|||||||0.84
91519275|NCT01814371|182912859|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.381|||||||Fisher Exact|||||||0.381
91519276|NCT01814371|182912860|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||0.143|||||||Fisher Exact|||||||0.143
91519277|NCT04683926|182912861|OTHER||AUC(0-36) Estimate (β1)|1.0227|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
91519278|NCT04683926|182912861|OTHER||AUC(inf) Estimate (β1)|1.0223|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
91519279|NCT04683926|182912861|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|AUC(0-inf) fed/fasted ratio|1.09|||||TWO_SIDED|90.0|1.05|1.12||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.12|1.05|
91519280|NCT04683926|182912862|OTHER||Cmax Estimate (β1)|0.9899|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
91519281|NCT04683926|182912862|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|Cmax 90% fed/fasted ratio|1.18|||||TWO_SIDED|90.0|1.08|1.28||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.28|1.08|
91519282|NCT01692782|182912869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||||TWO_SIDED||||||Mixed Models Analysis|||The 4 mg and 8 mg SEP 225289 groups were compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||
91519283|NCT01692782|182912869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38||||0.076|TWO_SIDED||||||Mixed Models Analysis|P-values of SEP 225289 4 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.||The 4 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.076
91519284|NCT01692782|182912869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88||||0.019|TWO_SIDED|||||p-value of SEP 225289 8 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.|Mixed Models Analysis|||The 8 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.019
91519285|NCT04341116|182912880|SUPERIORITY||Median Difference (Final Values)|9.0|STANDARD_ERROR_OF_MEAN|8.5||0.28|TWO_SIDED|95.0|-6.5|27.0|||Fisher Exact|||||27|-6.5|.28
91519286|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.641|||<|0.001|TWO_SIDED|95.0|1.247|2.159|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=12.514||Age of mother bearing, \<=30 years vs \>30 years||2.159|1.247|<0.001
91519287|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.793||||0.06|TWO_SIDED|95.0|0.622|1.01|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.529||Household register, local vs nonlocal||1.010|0.622|0.060
91519288|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.369||||0.006|TWO_SIDED|95.0|1.672|32.479|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.524||Mother's education level, illiteracy vs postgraduate or above||32.479|1.672|0.006
91519289|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.443||||0.102|TWO_SIDED|95.0|1.001|11.843|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.671||Mother's education level, elementary school vs postgraduate or above||11.843|1.001|0.102
91519290|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.064||||0.159|TWO_SIDED|95.0|0.933|10.067|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.984||Mother's education level, junior middle school vs postgraduate or above||10.067|0.933|0.159
91519291|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.321||||0.662|TWO_SIDED|95.0|0.71|7.589|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.191||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||7.589|0.710|0.662
91519292|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.306|||<|0.001|TWO_SIDED|95.0|0.399|4.277|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=13.525||Mother's education level, college/university vs postgraduate or above||4.277|0.399|<0.001
91519293|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.217||||0.043|TWO_SIDED|95.0|0.719|6.831|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.095||Family monthly income per capita, \<=600 RMB vs \>=10000 RMB||6.831|0.719|0.043
91519294|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.089||||0.01|TWO_SIDED|95.0|0.739|5.906|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=6.549||Family monthly income per capita, 600 to 1999 RMB vs \>=10000 RMB||5.906|0.739|0.010
91519295|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983||||0.021|TWO_SIDED|95.0|0.704|5.583|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.313||Family monthly income per capita, 2000 to 4999 RMB vs \>=10000 RMB||5.583|0.704|0.021
91519296|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.364|TWO_SIDED|95.0|0.344|3.267|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.824||Family monthly income per capita, 5000 to 7999 RMB vs \>=10000 RMB||3.267|0.344|0.364
91519297|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.175|TWO_SIDED|95.0|0.1|3.347|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.838||||3.347|0.100|0.175
91519298|NCT00952367|182912893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.516|||<|0.001|TWO_SIDED|95.0|0.4|0.666|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=25.960||Whether have brothers or sisters, no vs yes||0.666|0.400|<0.001
91519299|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.255||||0.057|TWO_SIDED|95.0|0.062|1.044|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.610||Birth information, preterm birth vs full-term birth||1.044|0.062|0.057
91519300|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.04|TWO_SIDED|95.0|0.451|0.981|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.228||Household register, local vs nonlocal||0.981|0.451|0.040
91519301|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.044|TWO_SIDED|95.0|0.758|1.844|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.074||Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding||1.844|0.758|0.044
91519302|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.707||||0.038|TWO_SIDED|95.0|0.42|1.191|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.316||Feeding manners within 6 months, mixed feeding vs pure formula milk feeding||1.191|0.420|0.038
91519303|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|92.229||||0.006|TWO_SIDED|95.0|3.993|2130.5|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.438||Father's education level, illiteracy vs postgraduate or above||2130.500|3.993|0.006
91519304|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.671||||0.778|TWO_SIDED|95.0|0.537|40.608|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.079||Father's education level, elementary school vs postgraduate or above||40.608|0.537|0.778
91519305|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.83||||0.756|TWO_SIDED|95.0|0.649|35.956|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.096||Father's education level, junior high school vs postgraduate or above||35.956|0.649|0.756
91519306|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.513||||0.179|TWO_SIDED|95.0|0.474|26.03|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.807||Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||26.030|0.474|0.179
91519307|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.029||||0.077|TWO_SIDED|95.0|0.412|22.292|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.131||Father's education level, college/university vs postgraduate or above||22.292|0.412|0.077
91519308|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984||||0.056|TWO_SIDED|95.0|0.968|1.0|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.648||Living space per capita, continuous variables||1.000|0.968|0.056
91519309|NCT00952367|182912894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.064|TWO_SIDED|95.0|0.522|1.018|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.432||Vaccination history of Hib, no vs yes||1.018|0.522|0.064
91519310|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438||||0.019|TWO_SIDED|95.0|0.221|0.871|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.538||Birth information, preterm birth vs full-term birth||0.871|0.221|0.019
91519311|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.546|||<|0.001|TWO_SIDED|95.0|0.423|0.703|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=21.938||Household register, local vs nonlocal||0.703|0.423|<0.001
91519312|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.137||||0.559|TWO_SIDED|95.0|0.473|9.652|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.341||Mother's education level, illiteracy vs graduate or above||9.652|0.473|0.559
91519313|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.793||||0.626|TWO_SIDED|95.0|0.596|5.394|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.238||Mother's education level, elementary school vs graduate or above||5.394|0.596|0.626
91519314|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.972||||0.193|TWO_SIDED|95.0|0.699|5.562|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.691||Mother's education level, junior middle school vs graduate or above||5.562|0.699|0.193
91519315|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.298|TWO_SIDED|95.0|0.679|5.353|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.081||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||5.353|0.679|0.298
91519316|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.233||||0.122|TWO_SIDED|95.0|0.439|3.464|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.395||Mother's education level, college/university vs postgraduate or above||3.464|0.439|0.122
91519317|NCT00952367|182912895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.001|TWO_SIDED|95.0|0.52|0.855|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=10.233||Whether have brothers or sisters, no vs yes||0.855|0.520|0.001
91519318|NCT05072080|182912908|SUPERIORITY||Mean Difference (Final Values)|96.6|||<|0.0001|TWO_SIDED|95.0|95.0|97.5||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||97.5|95.0|<0.0001
91581617|NCT02349425|183053226|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.169|TWO_SIDED|95.0|-8.6|1.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.6|-8.6|0.169
91519319|NCT05072080|182912910|SUPERIORITY||GMT Ratio|206.0|||<|0.0001|TWO_SIDED|95.0|183.0|232.0||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo).|Day 22||232|183|<0.0001
91519320|NCT05072080|182912912|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.85|1.14|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.14|0.85|
91519321|NCT05072080|182912912|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.84|1.12|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.12|0.84|
91519322|NCT05072080|182912912|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.10|0.82|
91519323|NCT05072080|182912914|SUPERIORITY||Mean Difference (Final Values)|96.0|||<|0.0001|TWO_SIDED|95.0|94.3|96.8||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||96.8|94.3|<0.0001
91519324|NCT05072080|182912914|SUPERIORITY||Mean Difference (Final Values)|84.0|||<|0.0001|TWO_SIDED|95.0|81.7|85.6||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||85.6|81.7|<0.0001
91519325|NCT05072080|182912914|SUPERIORITY||Mean Difference (Final Values)|46.1|||<|0.0001|TWO_SIDED|95.0|43.8|48.1||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 8||48.1|43.8|<0.0001
91519326|NCT05072080|182912916|SUPERIORITY||GMT Ratio|13.0|||<|0.0001|TWO_SIDED|95.0|11.0|14.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 8||14|11|<0.0001
91519327|NCT05072080|182912916|SUPERIORITY||GMT Ratio|144.0|||<|0.0001|TWO_SIDED|95.0|128.0|162.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 15||162|128|<0.0001
91519328|NCT05072080|182912916|SUPERIORITY||GMT Ratio|41.0|||<|0.0001|TWO_SIDED|95.0|37.0|46.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 183||46|37|<0.0001
91519329|NCT05072080|182912918|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 8||||<0.0001
91519330|NCT05072080|182912918|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
91519331|NCT05072080|182912918|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
91519332|NCT05072080|182912918|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
91519333|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|90.7|||<|0.0001|TWO_SIDED|95.0|88.7|91.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 8||91.9|88.7|<0.0001
91519334|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|98.7|||<|0.0001|TWO_SIDED|95.0|97.2|99.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||99.3|97.2|<0.0001
91519335|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|97.6|||<|0.0001|TWO_SIDED|95.0|95.8|98.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||98.5|95.8|<0.0001
91519336|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|96.8|||<|0.0001|TWO_SIDED|95.0|94.8|97.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||97.9|94.8|<0.0001
91519337|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|62.5|66.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 8||66.7|62.5|<0.0001
91519338|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|97.8|||<|0.0001|TWO_SIDED|95.0|96.3|98.4|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||98.4|96.3|<0.0001
91519339|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|97.2|||<|0.0001|TWO_SIDED|95.0|95.5|98.1|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||98.1|95.5|<0.0001
91519340|NCT05072080|182912920|SUPERIORITY||Mean Difference (Final Values)|91.4|||<|0.0001|TWO_SIDED|95.0|89.4|92.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||92.7|89.4|<0.0001
91519341|NCT00736645|182912940|OTHER|||||||0.5137|||||||Wilcoxon (Mann-Whitney)|||||||0.5137
91519342|NCT00736645|182912940|OTHER|||||||0.8994|||||||Wilcoxon (Mann-Whitney)|||||||0.8994
91519343|NCT00736645|182912940|OTHER|||||||0.3463|||||||Wilcoxon (Mann-Whitney)|||||||0.3463
91519344|NCT00736645|182912941|OTHER|||||||0.2609|||||||Wilcoxon (Mann-Whitney)|||||||0.2609
91519345|NCT00736645|182912941|OTHER|||||||0.7504|||||||Wilcoxon (Mann-Whitney)|||||||0.7504
91519346|NCT00736645|182912941|OTHER|||||||0.9727|||||||Wilcoxon (Mann-Whitney)|||||||0.9727
91519347|NCT02300220|182912943|SUPERIORITY||Cox Proportional Hazard|1.071||||0.764|TWO_SIDED|95.0|0.684|1.676|||Regression, Cox|||The primary endpoint was assessed using a Cox's proportional hazard model with pre-specified adjustment for patient's self-reported history of exacerbations over the previous year and with stratification for study centre. The onset of exacerbation will be monitored up to 90 days or at patient withdrawal.||1.676|0.684|0.764
91519348|NCT02300220|182912944|SUPERIORITY|||||||0.703|||||||Wilcoxon (Mann-Whitney)|||||||0.703
91519349|NCT02300220|182912946|SUPERIORITY|||||||0.239|||||||t-test, 2 sided|||||||0.239
91519350|NCT04322682|182912949|SUPERIORITY||Odds Ratio (OR)|0.79||||0.081|TWO_SIDED|95.1|0.61|1.03|||Chi-squared|||||1.03|0.61|0.081
91519351|NCT04322682|182912950|SUPERIORITY||Odds Ratio (OR)|0.56||||0.291|TWO_SIDED|95.0|0.19|1.67|||Chi-squared|||||1.67|0.19|0.291
91519352|NCT04322682|182912951|SUPERIORITY||Odds Ratio (OR)|0.79||||0.077|TWO_SIDED|95.0|0.6|1.03|||Chi-squared|||||1.03|0.60|0.077
91519353|NCT04322682|182912952|SUPERIORITY||Odds Ratio (OR)|0.53||||0.08|TWO_SIDED|95.0|0.25|1.09|||Chi-squared|||||1.09|0.25|0.080
91519354|NCT04322682|182912953|SUPERIORITY||Odds Ratio (OR)|0.75||||0.042|TWO_SIDED|95.0|0.57|0.99||P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.|Regression, Logistic|Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.||||0.99|0.57|0.042
91519355|NCT02238379|182912957|SUPERIORITY_OR_OTHER|||||||0.003||||||Main Effect of Emotion|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.003
91519356|NCT02238379|182912957|SUPERIORITY_OR_OTHER|||||||0.034||||||Main Effect of Face Type|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.034
91519357|NCT02238379|182912957|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Face Type|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
91519358|NCT02238379|182912957|SUPERIORITY_OR_OTHER|||||||0.03||||||Spray Type by Face Type Interaction|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
91519359|NCT02238379|182912957|SUPERIORITY_OR_OTHER||||||>|0.22||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||LPP Analysis||||>.22
91519360|NCT02238379|182912958|SUPERIORITY_OR_OTHER||||||>|0.14||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA||N170 Analysis||||>.14
91519361|NCT02238379|182912958|SUPERIORITY_OR_OTHER||||||>|0.17||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||P300 Analysis||||>.17
91519362|NCT02238379|182912958|SUPERIORITY_OR_OTHER||||||>|0.27||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||LPP Analysis||||>.27
91519363|NCT02238379|182912959|SUPERIORITY_OR_OTHER|||||||0.006||||||Main Effect of Emotion|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.006
91519364|NCT02238379|182912959|SUPERIORITY_OR_OTHER|||||||0.01||||||Main Effect of Hemisphere|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.01
91519365|NCT02238379|182912960|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Spray|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.03
91519366|NCT02238379|182912960|SUPERIORITY_OR_OTHER|||||||0.008||||||Main Effect of Hemisphere|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.008
91519367|NCT02238379|182912961|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
91519368|NCT02238379|182912963|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
91519369|NCT02238379|182912964|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
91519370|NCT02238379|182912965|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
91519371|NCT00605280|182912983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0047|TWO_SIDED|95.0|1.32|4.3||Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.|Cochran-Mantel-Haenszel|||||4.30|1.32|0.0047
91519372|NCT00605280|182912984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.1904|TWO_SIDED|95.0|0.85|2.53|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||2.53|0.85|0.1904
91519373|NCT00605280|182912985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.2466|TWO_SIDED|95.0|0.74|3.34|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.34|0.74|0.2466
91519374|NCT00605280|182912986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1388|TWO_SIDED|95.0|0.86|3.26|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.26|0.86|0.1388
91519375|NCT00605280|182912987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0468|TWO_SIDED|95.0|0.07|0.99|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.99|0.07|0.0468
91519376|NCT00605280|182912988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.1124|TWO_SIDED|95.0|0.73|11.55|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||11.55|0.73|0.1124
91519377|NCT00605280|182912989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.1788|TWO_SIDED|95.0|0.16|1.42|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||1.42|0.16|0.1788
91519378|NCT00605280|182912990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12||||0.0048|TWO_SIDED|95.0|1.45|18.06|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||18.06|1.45|0.0048
91519379|NCT00605280|182912991|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean|3.9||||0.004|TWO_SIDED|95.0|1.25|6.54|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||6.54|1.25|0.0040
91519380|NCT00605280|182912992|SUPERIORITY_OR_OTHER||LS Mean|4.57||||0.0011|TWO_SIDED|95.0|1.85|7.29|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.||||7.29|1.85|0.0011
91519381|NCT00605280|182912993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.0023|TWO_SIDED|95.0|0.24|0.74|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.74|0.24|0.0023
91519382|NCT00605280|182912994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0008|TWO_SIDED|95.0|0.23|0.69|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.69|0.23|0.0008
91519383|NCT01311674|182912999|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
91519384|NCT01311674|182913000|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91519385|NCT01311674|182913001|SUPERIORITY|||||||0.84|||||||Log Rank|||||||0.84
91519386|NCT01311674|182913002|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
91519387|NCT01311674|182913003|SUPERIORITY|||||||0.27|||||||Log Rank|||||||0.27
91519388|NCT02959996|182913006|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91519389|NCT02959996|182913007|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
91519390|NCT02959996|182913008|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91519391|NCT01329029|182913037|SUPERIORITY_OR_OTHER||Rate ratio|0.868|STANDARD_ERROR_OF_MEAN|0.0633||0.0529|TWO_SIDED|95.0|0.753|1.002||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||1.002|0.753|0.0529
91519392|NCT01329029|182913038|SUPERIORITY_OR_OTHER||LS Mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.0089|<|0.0001|TWO_SIDED|95.0|0.038|0.073|||ANCOVA|Analysis of Covariance (ANCOVA) including treatment by time interaction.||||0.073|0.038|<0.0001
91519393|NCT01329029|182913039|SUPERIORITY_OR_OTHER||Rate ratio|0.757|STANDARD_ERROR_OF_MEAN|0.0889||0.0175|TWO_SIDED|95.0|0.601|0.952|||Generalized Linear Regression|Analyzed using a negative binomial regression model excluding a correction for overdispersion.|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||0.952|0.601|0.0175
91519394|NCT01329029|182913040|SUPERIORITY_OR_OTHER||Rate ratio|0.914|STANDARD_ERROR_OF_MEAN|0.0771||0.2875|TWO_SIDED|95.0|0.775|1.078||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate COPD Exacerbations||1.078|0.775|0.2875
91519395|NCT01329029|182913040|SUPERIORITY_OR_OTHER||Rate Ratio|0.794|STANDARD_ERROR_OF_MEAN|0.0654||0.005|TWO_SIDED|95.0|0.675|0.933||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Mild, Moderate or Severe COPD Exacerbations||0.933|0.675|0.0050
91519396|NCT01329029|182913040|SUPERIORITY_OR_OTHER||Rate ratio|0.854|STANDARD_ERROR_OF_MEAN|0.0605||0.0262|TWO_SIDED|95.0|0.744|0.982||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|COPD Exacerbations treated with Glucocorticosteroids and/or Antibiotics||0.982|0.744|0.0262
91519397|NCT01329029|182913040|SUPERIORITY_OR_OTHER||Rate ratio|0.837|STANDARD_ERROR_OF_MEAN|0.0528||0.0047|TWO_SIDED|95.0|0.739|0.947||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate or Severe COPD Exacerbations and/or treated with Antibiotics||0.947|0.739|0.0047
91519398|NCT01329029|182913040|SUPERIORITY_OR_OTHER||Rate ratio|0.761|STANDARD_ERROR_OF_MEAN|0.0899||0.0209|TWO_SIDED|95.0|0.604|0.96||Level of significance: 5% 2-sided.|Generalized Linear Regression|Negative binomial regression model (estimates of exacerbation rates)|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Leading to Hospitalisation||0.960|0.604|0.0209
91519399|NCT01329029|182913042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917|STANDARD_ERROR_OF_MEAN|0.0549||0.1461|TWO_SIDED|95.0|0.815|1.031||Level of significance: 5% 2-sided.|Cox proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.031|0.815|0.1461
91519400|NCT01329029|182913043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.0842||0.027|TWO_SIDED|95.0|0.641|0.974||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment|||0.974|0.641|0.0270
91519401|NCT01329029|182913044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749|STANDARD_ERROR_OF_MEAN|0.1209||0.0731|TWO_SIDED|95.0|0.546|1.027||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment.|||1.027|0.546|0.0731
91519402|NCT01329029|182913045|SUPERIORITY_OR_OTHER||NNTB|9.0|||||TWO_SIDED|95.0|4.0|31.0||||||||31|4|
91519403|NCT01329029|182913048|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.0159|<|0.0001|TWO_SIDED|95.0|0.061|0.124||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and restricted maximum likelihood (REML).||||0.124|0.061|<0.0001
91519404|NCT01329029|182913049|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|0.013|0.038||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.038|0.013|<0.0001
91519405|NCT01329029|182913050|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.094|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.069|0.12||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.120|0.069|<0.0001
91519406|NCT01329029|182913052|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.283|STANDARD_ERROR_OF_MEAN|0.0941||0.0027|TWO_SIDED|95.0|-0.467|-0.098||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||-0.098|-0.467|0.0027
91519407|NCT01329029|182913053|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0439||0.7392|TWO_SIDED|95.0|-0.101|0.071||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||0.071|-0.101|0.7392
91519408|NCT01329029|182913056|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.285|STANDARD_ERROR_OF_MEAN|0.2175||0.1909|TWO_SIDED|95.0|-0.711|0.142||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.142|-0.711|0.1909
91519409|NCT01329029|182913058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.025|STANDARD_ERROR_OF_MEAN|0.3468||0.9414|TWO_SIDED|95.0|0.528|1.99||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.990|0.528|0.9414
91519410|NCT01329029|182913059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078|STANDARD_ERROR_OF_MEAN|0.5765||0.8876|TWO_SIDED|95.0|0.378|3.075|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||3.075|0.378|0.8876
91519411|NCT01329029|182913060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.529|STANDARD_ERROR_OF_MEAN|0.1463|<|0.0001|TWO_SIDED|95.0|1.268|1.845|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.845|1.268|<0.0001
91519412|NCT01329029|182913061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695|STANDARD_ERROR_OF_MEAN|0.2691||0.3477|TWO_SIDED|95.0|0.326|1.484||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.484|0.326|0.3477
91519413|NCT01329029|182913063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083|STANDARD_ERROR_OF_MEAN|0.3832||0.8208|TWO_SIDED|95.0|0.542|2.167||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||2.167|0.542|0.8208
91519414|NCT01329029|182913065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977|STANDARD_ERROR_OF_MEAN|0.0865||0.7943|TWO_SIDED|95.0|0.821|1.162||Level of significance: 5% 2-sided.|Cox-proportional hazards model|||||1.162|0.821|0.7943
91519415|NCT02178059|182913087|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|88.2|||||TWO_SIDED|90.0|81.03|96.02|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||96.02|81.03|
91519416|NCT02178059|182913088|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8052|TWO_SIDED|90.0|-0.17|0.17|||Wilcoxon signed rank test|||||0.17|-0.17|0.8052
91644225|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.376|||<|0.0001|TWO_SIDED|95.0|-0.601|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.601|<.0001
91519417|NCT02178059|182913092|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|91.44|||||TWO_SIDED|90.0|84.82|98.58|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||98.58|84.82|
91519418|NCT04128293|182913093|OTHER||Ratio of Geometric Least Square Mean|0.877|||||TWO_SIDED|90.0|0.7585|1.0152|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-infinity).|||1.0152|0.7585|
91519419|NCT04128293|182913095|OTHER||Ratio of Geometric Least Square Mean|0.892|||||TWO_SIDED|90.0|0.7778|1.0239|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-t).|||1.0239|0.7778|
91519420|NCT04128293|182913097|OTHER||Ratio of Geometric Least Square Mean|0.946|||||TWO_SIDED|90.0|0.8594|1.0404|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of Cmax.|||1.0404|0.8594|
91581618|NCT02349425|183053226|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.341|TWO_SIDED|95.0|-7.5|2.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.6|-7.5|0.341
91519421|NCT04128293|182913100|OTHER||Median Difference (Final Values)|0.533||||0.4252|TWO_SIDED|90.0|-1.0|2.0||The p-value was assessed based on the Wilcoxon signed-rank test.|Wilcoxon signed-rank test||The median difference and the 90 percent (%) confidence interval of the median difference was estimated from Hodges-Lehmann estimate.|||2.0000|-1.0000|0.4252
91519422|NCT04128293|182913100|OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|-0.75|5.25||The p-value was assessed based on the Wilcoxon rank sum test.|Wilcoxon rank sum test||The median difference and the 90% confidence interval of the median difference were estimated from Hodges-Lehmann estimate.|||5.2500|-0.7500|0.3125
91519423|NCT00514943|182913150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.7606|TWO_SIDED|95.0|-11.188|8.202||P-value obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions.|ANCOVA|Receipt of prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance for target lesions are covariates|Mean difference calculated is actually the adjusted mean difference.|||8.202|-11.188|0.7606
91519424|NCT00514943|182913163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.764|TWO_SIDED|95.0|0.64|1.387|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.387|0.640|0.764
91519425|NCT00514943|182913164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.219|TWO_SIDED|95.0|0.434|1.212|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.212|0.434|0.219
91519426|NCT00514943|182913165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.758|TWO_SIDED|95.0|0.708|1.608|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.608|0.708|0.758
91519427|NCT05072457|182913178|OTHER||||||<|0.05|||||||ANOVA|||"MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.~Null hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group."||||<.05
91519428|NCT05072457|182913179|OTHER||||||>|0.05|||||||ANOVA|||Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.||||>.05
91519429|NCT01786512|182913201|OTHER||Treatment difference|0.0112|STANDARD_ERROR_OF_MEAN|0.0033||0.0007|TWO_SIDED|95.0|0.0047|0.0176|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0176|0.0047|0.0007
91519430|NCT01786512|182913201|OTHER||Treatment difference|0.025|STANDARD_ERROR_OF_MEAN|0.0033|<|0.0001|TWO_SIDED|95.0|0.0184|0.0315|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0315|0.0184|<0.0001
91519431|NCT01786512|182913202|OTHER||Treatment difference|4.58|STANDARD_ERROR_OF_MEAN|1.56||0.0036|TWO_SIDED|95.0|1.5|7.65|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||7.65|1.50|0.0036
91519432|NCT01786512|182913202|OTHER||Treatment difference|3.63|STANDARD_ERROR_OF_MEAN|1.57||0.0217|TWO_SIDED|95.0|0.53|6.72|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||6.72|0.53|0.0217
91519433|NCT01786512|182913203|OTHER||Treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.058||0.1732|TWO_SIDED|95.0|-0.194|0.035|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.035|-0.194|0.1732
91706841|NCT02131233|183307793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-32.8|31.6|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||31.6|-32.8|
91519434|NCT01786512|182913203|OTHER||Treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.059||0.0027|TWO_SIDED|95.0|-0.295|-0.062|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.062|-0.295|0.0027
91771785|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.68||||0.1769|TWO_SIDED|95.0|0.5|44.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||44.00|0.50|0.1769
91519435|NCT01786512|182913204|OTHER||Treatment difference|-0.067|STANDARD_ERROR_OF_MEAN|0.051||0.1899|TWO_SIDED|95.0|-0.166|0.033|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.033|-0.166|0.1899
91519436|NCT01786512|182913204|OTHER||Treatment difference|-0.129|STANDARD_ERROR_OF_MEAN|0.052||0.0128|TWO_SIDED|95.0|-0.231|-0.028|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.028|-0.231|0.0128
91519437|NCT01786512|182913205|OTHER||Treatment difference|-1.34|STANDARD_ERROR_OF_MEAN|1.09||0.2177|TWO_SIDED|95.0|-3.47|0.79|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.79|-3.47|0.2177
91519438|NCT01786512|182913205|OTHER||Treatment difference|-2.97|STANDARD_ERROR_OF_MEAN|1.09||0.007|TWO_SIDED|95.0|-5.12|-0.81|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.81|-5.12|0.0070
91581619|NCT02349425|183053226|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.311|TWO_SIDED|95.0|-5.8|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-5.8|0.311
91519439|NCT01786512|182913206|OTHER||Treatment difference|-822.0|STANDARD_ERROR_OF_MEAN|353.0||0.0205|TWO_SIDED|95.0|-1516.0|-127.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-127|-1516|0.0205
91519440|NCT01786512|182913206|OTHER||Treatment difference|-970.0|STANDARD_ERROR_OF_MEAN|357.0||0.0069|TWO_SIDED|95.0|-1672.0|-268.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-268|-1672|0.0069
91519441|NCT00605293|182913209|SUPERIORITY_OR_OTHER|||||||0.4778|||||||Fisher Exact|||||||0.4778
91519442|NCT00781391|182913218|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.632|0.985||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||.985|.632|<.0001
91519443|NCT00781391|182913218|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|1.07||||0.0055|TWO_SIDED|97.5|0.874|1.314||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||1.314|.874|.0055
91519444|NCT00781391|182913219|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.719|1.029|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.029|.719|<.0001
91519445|NCT00781391|182913219|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|1.13||||0.0074|TWO_SIDED|97.5|0.955|1.336|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.336|.955|.0074
91519446|NCT00781391|182913220|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.634|0.989|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||.989|.634|<.0001
91519447|NCT00781391|182913220|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|Hazard Ratio (HR)|1.08||||0.0064|TWO_SIDED|97.5|0.878|1.32|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.32|.878|.0064
91519448|NCT00781391|182913221|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.72|1.032|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.032|.720|<.0001
91519449|NCT00781391|182913221|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|1.13||||0.0084|TWO_SIDED|97.5|0.958|1.34|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.34|.958|.0084
91519450|NCT00781391|182913222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.081|TWO_SIDED|99.0|0.709|1.068|||Log Rank|||The superiority analysis included the ITT analysis set||1.068|.709|.081
91710565|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|90.0|3.16|6.03|||t-test, 2 sided|||FEV1/FVC Day 8 (1 hrs post-dose)||6.03|3.16|<0.0001
91519451|NCT00781391|182913223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0053|TWO_SIDED|95.0|0.786|0.959|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.959|.786|.0053
91519452|NCT00781391|182913224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0109|TWO_SIDED|95.0|0.806|0.972|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.972|.806|.0109
91519453|NCT00781391|182913225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0168|TWO_SIDED|95.0|0.823|0.981|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.981|.823|.0168
91519454|NCT00781391|182913226|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0009|TWO_SIDED|95.0|0.707|0.914|||Regression, Cox|||All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period||.914|.707|.0009
91519455|NCT00781391|182913226|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.47|||<|0.0001|TWO_SIDED|95.0|0.406|0.548|||Regression, Cox|||"All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period.~The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor"||.548|.406|<.0001
91519456|NCT00781391|182913226|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.918|||Regression, Cox|||Major or Clinically Relevant Non-Major, high dose vs. warfarin||.918|.800|<.0001
91519457|NCT00781391|182913226|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.575|0.666|||Regression, Cox|||Major or Clinically Relevant Non-Major, low dose vs. warfarin||.666|.575|<.0001
91519458|NCT01984684|182913227|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in responder rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|3.1|||||TWO_SIDED|95.0|-2.0|8.3||||||||8.3|-2.0|
91519459|NCT01984684|182913228|NON_INFERIORITY|Analysis of the investigator's assessment of response of signs and symptoms of infection (cure only) was performed using the Miettinen-Nurminen method without stratification for the ITT analysis set.|Difference in Cure Rates|-2.0|||||TWO_SIDED|95.0|-8.6|4.6||||||||4.6|-8.6|
91519460|NCT01984684|182913229|NON_INFERIORITY|Analysis of the investigator's assessment of response (cure only) at the Late Follow-up Visit was assessed using the Miettinen-Nurminen method without stratification.|Difference in Cure Rates|-3.1|||||TWO_SIDED|95.0|-9.3|3.1||||||||3.1|-9.3|
91519461|NCT04322604|182913230|SUPERIORITY||Percent Difference from Placebo|80.1|||<|0.0001|TWO_SIDED|95.0|70.1|87.9|||Fisher Exact|||||87.9|70.1|<0.0001
91519462|NCT04322604|182913231|SUPERIORITY||LSM Difference from Placebo|1.5||||0.3427|TWO_SIDED|95.0|-1.6|4.7|||ANCOVA|||||4.7|-1.6|0.3427
91519463|NCT04322604|182913232|SUPERIORITY||LSM Difference from Placebo|-41.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-34.2|||ANCOVA|||||-34.2|-48.1|<0.0001
91519464|NCT04322604|182913233|SUPERIORITY||Percent Difference from Placebo|81.3|||<|0.0001|TWO_SIDED|95.0|71.7|88.8|||Fisher Exact|||||88.8|71.7|<0.0001
91519465|NCT04322604|182913234|SUPERIORITY||Percent Difference from Placebo|39.5|||<|0.0001|TWO_SIDED|95.0|25.4|52.2|||Fisher Exact|||||52.2|25.4|<0.0001
91519466|NCT04322604|182913235|SUPERIORITY||Percent Difference from Placebo|7.0||||0.3549|TWO_SIDED|95.0|-7.4|21.6|||Fisher Exact|||||21.6|-7.4|0.3549
91519467|NCT04322604|182913236|SUPERIORITY||Percent Difference from Placebo|8.3||||0.2262|TWO_SIDED|95.0|-6.3|22.7|||Fisher Exact|||||22.7|-6.3|0.2262
91519468|NCT04322604|182913237|SUPERIORITY||LSM Difference from Placebo|5.0||||0.3812|TWO_SIDED|95.0|-6.1|16.0|||Mixed Models Analysis|||Week 24 Percent Change from Baseline||16.0|-6.1|0.3812
91519469|NCT00295022|182913303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.35|-1.88|||ANCOVA|||||-1.88|-4.35|<0.001
91519470|NCT00295022|182913303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||=|0.001|TWO_SIDED|95.0|-2.04|0.18|||ANCOVA|||||0.18|-2.04|=0.001
91519471|NCT00295022|182913303|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.19|||<|0.001|TWO_SIDED|95.0|-3.43|-0.95|||ANCOVA|||||-0.95|-3.43|<0.001
91519472|NCT01239030|182913334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||ANCOVA|||||||0.0046
91519473|NCT04403698|182913335|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (CTX-I) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||<0.01
91519474|NCT04403698|182913336|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (PINP) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||0.05
91519475|NCT04403698|182913337|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups at week 48||||0.042
91519476|NCT04403698|182913338|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups.||||0.042
91519477|NCT00977665|182913341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.603||||0.6984|TWO_SIDED|95.0|-3.677|2.47||A priori threshold for statistical significance is 0.05.|repeated measures model|Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.||||2.470|-3.677|0.6984
91519478|NCT00977665|182913350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.646|2.186||||||||2.186|0.646|
91519479|NCT01662882|182913395|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0253
91519480|NCT01662882|182913395|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0004
91519481|NCT01662882|182913395|SUPERIORITY_OR_OTHER|||||||0.4184||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.4184
91519482|NCT01662882|182913395|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0008
91519483|NCT01662882|182913396|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||0.0039
91519484|NCT01662882|182913396|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0357
91519485|NCT01662882|182913396|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0010
91519486|NCT01662882|182913396|SUPERIORITY_OR_OTHER|||||||0.2118||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.2118
91519487|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2968|TWO_SIDED|95.0|-0.18|0.59|||ANCOVA|||||0.59|-0.18|0.2968
91519488|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.186|TWO_SIDED|95.0|-0.64|0.12|||ANCOVA|||||0.12|-0.64|0.1860
91519489|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0027|TWO_SIDED|95.0|-1.03|-0.22|||ANCOVA|||||-0.22|-1.03|0.0027
91519490|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.2766|TWO_SIDED|95.0|-0.62|0.18|||ANCOVA|||||0.18|-0.62|0.2766
91519491|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0057|TWO_SIDED|95.0|-0.94|-0.16|||ANCOVA|||||-0.16|-0.94|0.0057
91519492|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0032|TWO_SIDED|95.0|-0.96|-0.19|||ANCOVA|||||-0.19|-0.96|0.0032
91519493|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0786|TWO_SIDED|95.0|-0.72|0.04|||ANCOVA|||||0.04|-0.72|0.0786
91519494|NCT00518115|182913397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0022|TWO_SIDED|95.0|-0.99|-0.22|||ANCOVA|||||-0.22|-0.99|0.0022
91519495|NCT04891419|182913416|SUPERIORITY||Rate Difference|91.1|||<|0.0001|TWO_SIDED|95.0|83.7|95.9||P-value is based on the Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||95.9|83.7|<.0001
91519496|NCT04891419|182913417|SUPERIORITY||Control Difference|54.5|STANDARD_ERROR_OF_MEAN|2.69|<|0.0001|TWO_SIDED|95.0|49.2|59.9||P-value estimated using mixed effects model.|Mixed Models Analysis||95% CI estimated using mixed effects model.|||59.9|49.2|<.0001
91519497|NCT04891419|182913418|SUPERIORITY||Control Difference|42.8|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|37.6|48.0||95% CI and p-value estimated using mixed effects model.|Mixed Models Analysis|||||48.0|37.6|<.0001
91519498|NCT04891419|182913419|SUPERIORITY||Rate Difference|93.1|||<|0.0001|TWO_SIDED|95.0|86.1|97.2||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||97.2|86.1|<.0001
91519499|NCT04891419|182913420|SUPERIORITY||Rate Difference|92.1|||<|0.0001|TWO_SIDED|95.0|84.9|96.5||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||96.5|84.9|<.0001
91519500|NCT01055769|182913421|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|97.81|||||TWO_SIDED|90.0|93.11|102.75||||||Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.75|93.11|
91519501|NCT01055769|182913422|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|113.67|||||TWO_SIDED|90.0|105.26|122.75||||||Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||122.75|105.26|
91519502|NCT01055769|182913423|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric means ratio|97.65|||||TWO_SIDED|90.0|92.92|102.63||||||Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.63|92.92|
91519503|NCT02235493|182913426|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in MPOMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total MPOMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median MPOMA-G score used in the analyses.||||0.0625
91581620|NCT02349425|183053226|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.128|TWO_SIDED|95.0|-8.6|1.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.1|-8.6|0.128
91581621|NCT02349425|183053227|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.613|TWO_SIDED|95.0|-3.5|5.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.9|-3.5|0.613
91519504|NCT02235493|182913427|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in POMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total POMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median POMA-G score used in the analyses.||||0.1250
91519505|NCT00827918|182913428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.859|TWO_SIDED|95.0|-7.0|5.8|||Difference in the Least Squares Mean|||||5.8|-7.0|0.8590
91519506|NCT00827918|182913428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.2534|TWO_SIDED|95.0|-11.7|3.1|||Difference in the Least Squares Mean|||||3.1|-11.7|0.2534
91519507|NCT00827918|182913431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4976|TWO_SIDED|95.0|0.62|2.64|||Generalized linear mixed analysis model|||||2.64|0.62|0.4976
91519508|NCT00827918|182913431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0653|TWO_SIDED|95.0|0.95|5.09|||Generalized linear mixed analysis model|||||5.09|0.95|0.0653
91519509|NCT00827918|182913432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8199|TWO_SIDED|95.0|-0.4|0.3|||Constrained longitudinal data analysis|||||0.3|-0.4|0.8199
91519510|NCT00827918|182913432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.4|0.4|||Constrained longitudinal data analysis|||||0.4|-0.4|0.9486
91519511|NCT00827918|182913433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9937|TWO_SIDED|95.0|-2.0|2.0|||Constrained longitudinal data analysis|||||2.0|-2.0|0.9937
91519512|NCT00827918|182913433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.2406|TWO_SIDED|95.0|-3.6|0.9|||Constrained longitudinal data analysis|||||0.9|-3.6|0.2406
91519513|NCT00827918|182913434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.5953|TWO_SIDED|95.0|-2.0|1.2|||Constrained longitudinal data analysis|||||1.2|-2.0|0.5953
91519514|NCT00827918|182913434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8567|TWO_SIDED|95.0|-2.0|1.6|||Constrained longitudinal data analysis|||||1.6|-2.0|0.8567
91519515|NCT02979262|182913442|SUPERIORITY||||||>|0.1|||||||Repeated Measures GLM|Time 2 at 16 weeks||||||>.10
91644226|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.314||||0.0014|TWO_SIDED|95.0|-0.537|-0.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.090|-0.537|0.0014
91710566|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|90.0|3.56|6.39|||t-test, 2 sided|||FEV1/FVC Day 8 (2 hrs post-dose)||6.39|3.56|<0.0001
91519516|NCT02979262|182913443|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
91519517|NCT02979262|182913444|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
91519518|NCT02979262|182913445|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
91519519|NCT02979262|182913446|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
91519520|NCT02979262|182913447|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
91519521|NCT01565707|182913530|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|12.1|STANDARD_ERROR_OF_MEAN|6.0||0.046|TWO_SIDED|95.0|0.2|24.0|||ANCOVA|From an ANCOVA (analysis of covariance) model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||"The following hypotheses were tested at the 2-sided significance level 0.05:~* H0: Change from baseline to EoT in mean MVV per micturition is the same for placebo and solifenacin succinate oral suspension~* H1: Change from baseline to EoT in mean MVV per micturition is not the same for placebo and solifenacin succinate oral suspension"||24.0|0.2|0.046
91519522|NCT01565707|182913530|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|15.7|||TWO_SIDED|95.0|-36.7|27.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||27.4|-36.7|
91519523|NCT01565707|182913531|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|31.9|STANDARD_ERROR_OF_MEAN|13.9||0.024|TWO_SIDED|95.0|4.3|59.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||59.5|4.3|0.024
91519524|NCT01565707|182913531|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|29.1|||TWO_SIDED|95.0|-76.5|41.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||41.9|-76.5|
91519525|NCT01565707|182913532|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.763|TWO_SIDED|95.0|-0.3|0.4||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.4|-0.3|0.763
91519526|NCT01565707|182913532|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.8|1.0|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.0|-0.8|
91519527|NCT01565707|182913533|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.402|TWO_SIDED|95.0|-0.5|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.5|0.402
91519528|NCT01565707|182913533|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.5|0.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.4|-1.5|
91519529|NCT01565707|182913534|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.63|TWO_SIDED|95.0|0.0|0.2||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.2|0.0|0.630
91519530|NCT01565707|182913534|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.2|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate..|||0.2|-0.2|
91519531|NCT01565707|182913535|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.563|TWO_SIDED|95.0|-1.0|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-1.0|0.563
91519532|NCT01565707|182913535|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.6|1.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.9|-1.6|
91519533|NCT01565707|182913536|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.77|TWO_SIDED|95.0|-0.9|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.9|0.770
91519534|NCT01565707|182913536|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.4|1.3|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.3|-0.4|
91519535|NCT01565707|182913537|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.303|TWO_SIDED|95.0|-0.8|0.2||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|ANCOVA|||||0.2|-0.8|0.303
91519536|NCT01565707|182913537|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.9|1.1|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.1|-0.9|
91519537|NCT01565707|182913538|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.64|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.5|-0.8|0.640
91519538|NCT01565707|182913538|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.9|1.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.4|-0.9|
91519539|NCT01565707|182913539|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.846|TWO_SIDED|95.0|-0.3|0.1||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.1|-0.3|0.846
91519540|NCT01565707|182913539|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.0|0.5|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.5|-1.0|
91519541|NCT01565707|182913540|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.4|0.8|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.8|-1.4|
91519542|NCT01371851|182913550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0529||||0.05|TWO_SIDED||||||Regression, Logistic|||The analysis was applied to urine data obtained at all time points during weeks 1-8.||||0.05
91519543|NCT03969719|182913557|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-12.44||||0.0696|TWO_SIDED|90.0|-22.37|-1.25|||ANCOVA|||||-1.25|-22.37|0.0696
91519544|NCT03969719|182913557|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-14.64||||0.0288|TWO_SIDED|90.0|-24.18|-3.89|||ANCOVA|||||-3.89|-24.18|0.0288
91519545|NCT03969719|182913558|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.08||||0.6336|TWO_SIDED|90.0|-0.36|0.2|||Mixed Models Analysis|||||0.20|-0.36|0.6336
91519546|NCT03969719|182913558|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.25||||0.1266|TWO_SIDED|90.0|-0.52|0.02|||Mixed Models Analysis|||||0.02|-0.52|0.1266
91519547|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.87|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.87
91519548|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.78|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.78
91519549|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.67|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.67
91519550|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.52|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.52
91519551|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.39|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.39
91519552|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.26|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.26
91519553|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.31|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.31
91519554|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.22|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.22
91519555|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.14
91519556|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.09
91519557|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.05|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.05
91519558|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.03|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.03
91519559|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.85|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.85
91519560|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.79|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.79
91519561|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.71|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.71
91519562|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.61|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.61
91519563|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.51|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.51
91519564|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.41
91519565|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.47|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.47
91519566|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.36|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.36
91519567|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.26|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.26
91581622|NCT02349425|183053227|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.743|TWO_SIDED|95.0|-4.3|3.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||3.1|-4.3|.743
91644227|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.381|||<|0.0001|TWO_SIDED|95.0|-0.604|-0.157|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.157|-0.604|<.0001
91644228|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.484|-0.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.977|-1.484|<.0001
91644229|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.284|||<|0.0001|TWO_SIDED|95.0|-1.539|-1.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.029|-1.539|<.0001
91644230|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.564|-1.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.065|-1.564|<.0001
91644231|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.259|||<|0.0001|TWO_SIDED|95.0|-1.512|-1.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.006|-1.512|<.0001
91644232|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.972|||<|0.0001|TWO_SIDED|95.0|0.732|1.211|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.211|0.732|<.0001
91644233|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.918|||<|0.0001|TWO_SIDED|95.0|0.676|1.161|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.161|0.676|<.0001
91644234|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.037|||<|0.0001|TWO_SIDED|95.0|0.797|1.278|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.278|0.797|<.0001
91706842|NCT01006590|183307853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.26|TWO_SIDED|95.0|-0.26|0.07|||ANCOVA|With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment||The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%||0.07|-0.26|0.26
91706843|NCT01006590|183307854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8|STANDARD_ERROR_OF_MEAN|5.79||0.3202|TWO_SIDED|95.0|-5.6|17.1|||Regression, Logistic|||||17.1|-5.6|0.3202
91644235|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.914|||<|0.0001|TWO_SIDED|95.0|0.672|1.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.156|0.672|<.0001
91644236|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.121||||0.7939|TWO_SIDED|95.0|-0.147|0.388|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.388|-0.147|0.7939
91644237|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.26|0.281|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.281|-0.260|1.0000
91644238|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.228|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.301|-0.228|1.0000
91706844|NCT01006590|183307855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|4.58||0.6203|TWO_SIDED|95.0|-6.7|11.3|||Regression, Logistic|||||11.3|-6.7|0.6203
91644239|NCT03692078|183180091|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.233|0.305|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.305|-0.233|1.0000
91644240|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|7.367|||<|0.0001|TWO_SIDED|95.0|7.25|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||7.485|7.250|<.0001
91706845|NCT01006590|183307856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.7627|TWO_SIDED|95.0|-0.38|0.52|||ANCOVA|||||0.52|-0.38|0.7627
91706846|NCT01006590|183307857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.19||0.7701|TWO_SIDED|95.0|-2.0|2.7|||ANCOVA|||||2.7|-2.0|0.7701
91706847|NCT01006590|183307858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|4.34||0.5882|TWO_SIDED|95.0|-6.22|10.93|||ANCOVA|||||10.93|-6.22|0.5882
91706848|NCT04942210|183307904|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|0.3|||||TWO_SIDED|95.0|-1.2|3.2|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.2|-1.2|
91706849|NCT02776670|183307918|NON_INFERIORITY|Noninferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (Systane Balance-Refresh Optive Advanced/Optive Plus) was above the noninferiority margin of -1.0 second.|Mean Difference (Final Values)|0.13|||<|0.0001|TWO_SIDED|95.0|-0.341|0.601||p-value for testing noninferiority of Systane Balance with respect to Refresh Optive Advanced/Refresh Optive Plus is calculated for predefined noninferiority margin of -1.0 second.|Mixed model repeated measures (MMRM)|||||0.601|-0.341|<0.0001
91706850|NCT02776670|183307919|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.31|TWO_SIDED|95.0|-0.349|0.585|||MMRM|||||0.585|-0.349|0.310
91706851|NCT02776670|183307921|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.618|TWO_SIDED|95.0|-6.4|4.7|||MMRM|||||4.7|-6.4|0.618
91706852|NCT05460078|183307924|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.16|1.68|||Mixed Models Analysis|||||1.68|1.16|<0.001
91519568|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.19|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.19
91519569|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.13|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.13
91519570|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.09
91519571|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.78|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.78
91519572|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.69|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.69
91519573|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.59
91519574|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.50
91519575|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.39|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.39
91519576|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.30
91519577|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.68|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.68
91519578|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.59
91519579|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.50
91519580|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.4|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.40
91519581|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.30
91519582|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.22|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.22
91519583|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.41
91519584|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.32|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.32
91519585|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.24|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.24
91581623|NCT02349425|183053227|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.589|TWO_SIDED|95.0|-4.1|2.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.3|-4.1|0.589
91644241|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|7.368|||<|0.0001|TWO_SIDED|95.0|7.251|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||7.485|7.251|<.0001
91644242|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.883|||<|0.0001|TWO_SIDED|95.0|6.773|6.994|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||6.994|6.773|<.0001
91644243|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.892|||<|0.0001|TWO_SIDED|95.0|6.78|7.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||7.004|6.780|<.0001
91644244|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.942|||<|0.0001|TWO_SIDED|95.0|6.829|7.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||7.054|6.829|<.0001
91644245|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.896|||<|0.0001|TWO_SIDED|95.0|6.784|7.008|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||7.008|6.784|<.0001
91644246|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.879|||<|0.0001|TWO_SIDED|95.0|5.739|6.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||6.019|5.739|<.0001
91706853|NCT05460078|183307925|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.18|1.65|||Mixed Models Analysis|||||1.65|1.18|<0.001
91706854|NCT05460078|183307926|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.54|2.48|||Mixed Models Analysis|||||2.48|1.54|<0.001
91519586|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.16|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.16
91519587|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.11|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.11
91519588|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.07|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.07
91706855|NCT05460078|183307927|SUPERIORITY||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|95.0|1.17|1.66|||Mixed Models Analysis|||||1.66|1.17|<0.001
91706856|NCT01119846|183307968|SUPERIORITY_OR_OTHER||Slope|0.5782|||||TWO_SIDED|90.0|0.523|0.6335|||||Dose Proportionality for GSK1292263 Using the Power Model.|||0.6335|0.5230|
91706857|NCT01119846|183307970|SUPERIORITY_OR_OTHER||Slope|0.5828|||||TWO_SIDED|90.0|0.5282|0.6375|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-24.|||0.6375|0.5282|
91706858|NCT01119846|183307970|SUPERIORITY_OR_OTHER||Slope|0.5808|||||TWO_SIDED|90.0|0.5325|0.6291|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-last.|||0.6291|0.5325|
91519589|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.41|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.41
91644247|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.804|||<|0.0001|TWO_SIDED|95.0|5.662|5.946|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.946|5.662|<.0001
91644248|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.916|||<|0.0001|TWO_SIDED|95.0|5.778|6.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||6.054|5.778|<.0001
91644249|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.917|||<|0.0001|TWO_SIDED|95.0|5.775|6.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||6.058|5.775|<.0001
91644250|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.017|||<|0.0001|TWO_SIDED|95.0|5.881|6.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||6.153|5.881|<.0001
91644251|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.012|||<|0.0001|TWO_SIDED|95.0|5.874|6.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||6.149|5.874|<.0001
91644252|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.484|||<|0.0001|TWO_SIDED|95.0|-0.711|-0.257|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.257|-0.711|<.0001
91644253|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.476|||<|0.0001|TWO_SIDED|95.0|-0.705|-0.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.248|-0.705|<.0001
91644254|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.426|||<|0.0001|TWO_SIDED|95.0|-0.654|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.198|-0.654|<.0001
91644255|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.472|||<|0.0001|TWO_SIDED|95.0|-0.701|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.244|-0.701|<.0001
91519590|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.32|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.32
91644256|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.489|||<|0.0001|TWO_SIDED|95.0|-1.747|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.747|<.0001
91644257|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Final Values)|-1.564|||<|0.0001|TWO_SIDED|95.0|-1.825|-1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.304|-1.825|<.0001
91644258|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.451|||<|0.0001|TWO_SIDED|95.0|-1.706|-1.197|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.197|-1.706|<.0001
91644259|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.193|-1.710|<.0001
91644260|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.866|||<|0.0001|TWO_SIDED|95.0|0.622|1.11|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.110|0.622|<.0001
91644261|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.88|||<|0.0001|TWO_SIDED|95.0|0.633|1.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.128|0.633|<.0001
91644262|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.924|||<|0.0001|TWO_SIDED|95.0|0.68|1.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.169|0.680|<.0001
91644263|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.884|||<|0.0001|TWO_SIDED|95.0|0.638|1.131|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.131|0.638|<.0001
91644264|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.138||||0.68|TWO_SIDED|95.0|-0.411|0.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.134|-0.411|0.6800
91581624|NCT02349425|183053227|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.205|TWO_SIDED|95.0|-13.2|2.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.9|-13.2|0.205
91644265|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.208||||0.2371|TWO_SIDED|95.0|-0.483|0.068|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.068|-0.483|0.2371
91644266|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9133|TWO_SIDED|95.0|-0.371|0.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.169|-0.371|0.9133
91644267|NCT03692078|183180093|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.095||||0.9432|TWO_SIDED|95.0|-0.37|0.18|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.180|-0.370|0.9432
91644268|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.513|||<|0.0001|TWO_SIDED|95.0|4.383|4.643|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||4.643|4.383|<.0001
91644269|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.491|||<|0.0001|TWO_SIDED|95.0|4.371|4.61|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||4.610|4.371|<.0001
91644270|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.15|||<|0.0001|TWO_SIDED|95.0|4.027|4.272|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||4.272|4.027|<.0001
91644271|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.128|||<|0.0001|TWO_SIDED|95.0|4.014|4.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||4.242|4.014|<.0001
91644272|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.176|||<|0.0001|TWO_SIDED|95.0|4.051|4.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||4.301|4.051|<.0001
91706859|NCT01119846|183307985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|||||TWO_SIDED|95.0|-1.17|1.1||||||||1.10|-1.17|
91706860|NCT01119846|183307985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.225|||||TWO_SIDED|95.0|-0.9|1.35||||||||1.35|-0.90|
91706861|NCT01119846|183307985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|||||TWO_SIDED|95.0|-1.1|1.19||||||||1.19|-1.10|
91706862|NCT01119846|183307985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.679|||||TWO_SIDED|95.0|-1.8|0.45||||||||0.45|-1.80|
91706863|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|-1.8|2.33|||||Comparison of AUC(0-24)|||2.33|-1.80|
91519591|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.25|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.25
91644273|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.139|||<|0.0001|TWO_SIDED|95.0|4.024|4.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||4.254|4.024|<.0001
91644274|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.997|||<|0.0001|TWO_SIDED|95.0|2.842|3.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||3.153|2.842|<.0001
91644275|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.994|||<|0.0001|TWO_SIDED|95.0|2.849|3.138|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||3.138|2.849|<.0001
91644276|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.317|||<|0.0001|TWO_SIDED|95.0|3.164|3.47|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||3.470|3.164|<.0001
91644277|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.342|||<|0.0001|TWO_SIDED|95.0|3.199|3.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||3.486|3.199|<.0001
91644278|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.036|||<|0.0001|TWO_SIDED|95.0|2.886|3.187|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||3.187|2.886|<.0001
91644279|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.159|||<|0.0001|TWO_SIDED|95.0|3.019|3.299|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||3.299|3.019|<.0001
91644280|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.363||||0.0008|TWO_SIDED|95.0|-0.613|-0.113|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.113|-0.613|0.0008
91706864|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.614|||||TWO_SIDED|95.0|-1.53|2.76|||||Comparison of AUC(0-24)|||2.76|-1.53|
91706865|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|||||TWO_SIDED|95.0|-1.64|2.54|||||Comparison of AUC(0-24)|||2.54|-1.64|
91706866|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.469|||||TWO_SIDED|95.0|-1.39|2.33|||||Comparison of AUC(0-24)|||2.33|-1.39|
91519592|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.18|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.18
91706867|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.53|1.95|||||Comparison of AUC(0-13)|||1.95|-2.53|
91706868|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|||||TWO_SIDED|95.0|-2.35|2.3|||||Comparison of AUC(0-13)|||2.30|-2.35|
91644281|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.362||||0.0003|TWO_SIDED|95.0|-0.595|-0.129|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.129|-0.595|0.0003
91644282|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.337||||0.0026|TWO_SIDED|95.0|-0.588|-0.085|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.085|-0.588|0.0026
91519593|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.12|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.12
91519594|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.07|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.07
91519595|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.45|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.45
91519596|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.37|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.37
91519597|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.3|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.30
91519598|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.22|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.22
91519599|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.17|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.17
91519600|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.12|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.12
91519601|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.72|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.72
91519602|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.65|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.65
91519603|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.57|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.57
91519604|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.48|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.48
91706869|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.163|||||TWO_SIDED|95.0|-2.48|2.15|||||Comparison of AUC(0-13)|||2.15|-2.48|
91706870|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||||TWO_SIDED|95.0|-1.88|2.21|||||Comparison of AUC(0-13)|||2.21|-1.88|
91519605|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.39|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.39
91581625|NCT02349425|183053228|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0811|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.1|-1.4|0.0811
91644283|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.351||||0.0004|TWO_SIDED|95.0|-0.584|-0.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.118|-0.584|0.0004
91644284|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.515|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.800|<.0001
91644285|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.497|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.231|-1.762|<.0001
91644286|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.477|-0.915|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.915|-1.477|<.0001
91644287|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.148|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.886|-1.410|<.0001
91519606|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.30
91644288|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.113|||<|0.0001|TWO_SIDED|95.0|0.844|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.382|0.844|<.0001
91644289|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.969|||<|0.0001|TWO_SIDED|95.0|0.717|1.221|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.221|0.717|<.0001
91644290|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.139|||<|0.0001|TWO_SIDED|95.0|0.869|1.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.410|0.869|<.0001
91706871|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.58|0.87|||||Comparison of iAUC(0-13)|||0.87|-1.58|
91706872|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||||TWO_SIDED|95.0|-1.41|1.13|||||Comparison of iAUC(0-13)|||1.13|-1.41|
91706873|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.091|||||TWO_SIDED|95.0|-1.36|1.18|||||Comparison of iAUC(0-13)|||1.18|-1.36|
91706874|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.206|||||TWO_SIDED|95.0|-1.33|0.91|||||Comparison of iAUC(0-13)|||0.91|-1.33|
91644291|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.98|||<|0.0001|TWO_SIDED|95.0|0.728|1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.231|0.728|<.0001
91644292|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.039||||1|TWO_SIDED|95.0|-0.34|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.262|-0.340|1.0000
91644293|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.166||||0.5184|TWO_SIDED|95.0|-0.447|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.115|-0.447|0.5184
91644294|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.28||||0.0743|TWO_SIDED|95.0|-0.017|0.578|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.578|-0.017|0.0743
91644295|NCT03692078|183180095|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.183||||0.3889|TWO_SIDED|95.0|-0.095|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|-0.095|0.3889
91644296|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.264|||<|0.0001|TWO_SIDED|95.0|5.155|5.373|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||5.373|5.155|<.0001
91644297|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.204|||<|0.0001|TWO_SIDED|95.0|5.106|5.302|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||5.302|5.106|<.0001
91644298|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.005|||<|0.0001|TWO_SIDED|95.0|4.902|5.108|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.108|4.902|<.0001
91644299|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.958|||<|0.0001|TWO_SIDED|95.0|4.864|5.051|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.051|4.864|<.0001
91706875|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.499|||||TWO_SIDED|95.0|-1.68|0.68|||||Comparison of iAUC(0-24)|||0.68|-1.68|
91706876|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-1.24|1.21|||||Comparison of iAUC(0-24)|||1.21|-1.24|
91644300|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.114|||<|0.0001|TWO_SIDED|95.0|5.009|5.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.219|5.009|<.0001
91644301|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.052|||<|0.0001|TWO_SIDED|95.0|4.958|5.146|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.146|4.958|<.0001
91644302|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.539|||<|0.0001|TWO_SIDED|95.0|4.407|4.671|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||4.671|4.407|<.0001
91644303|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.415|||<|0.0001|TWO_SIDED|95.0|4.295|4.534|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||4.534|4.295|<.0001
91644304|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.431|||<|0.0001|TWO_SIDED|95.0|4.302|4.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.560|4.302|<.0001
91644305|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.361|||<|0.0001|TWO_SIDED|95.0|4.243|4.48|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||4.480|4.243|<.0001
91644306|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.486|||<|0.0001|TWO_SIDED|95.0|4.359|4.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.612|4.359|<.0001
91644307|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.588|||<|0.0001|TWO_SIDED|95.0|4.473|4.703|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||4.703|4.473|<.0001
91644308|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.259||||0.0073|TWO_SIDED|95.0|-0.469|-0.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.049|-0.469|0.0073
91706877|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-1.44|0.95|||||Comparison of iAUC(0-24)|||0.95|-1.44|
91581626|NCT02349425|183053228|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0097|TWO_SIDED|95.0|-2.2|-0.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.3|-2.2|0.0097
91644309|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.246||||0.0041|TWO_SIDED|95.0|-0.438|-0.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.055|-0.438|0.0041
91644310|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.15||||0.308|TWO_SIDED|95.0|-0.361|0.061|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.061|-0.361|0.3080
91519607|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.76|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.76
91519608|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.71|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.71
91519609|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.65|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.65
91519610|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.59|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.59
91519611|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.53|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.53
91644311|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.152||||0.1982|TWO_SIDED|95.0|-0.343|0.039|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.039|-0.343|0.1982
91706878|NCT01119846|183307986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.661|||||TWO_SIDED|95.0|-1.72|0.4|||||Comparison of iAUC(0-24)|||0.40|-1.72|
91706879|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.898|||||TWO_SIDED|95.0|-479.74|379.94|||||Comparison of C-peptide, AUC 0-12|||379.94|-479.74|
91706880|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.642|||||TWO_SIDED|95.0|-507.32|384.04|||||Comparison of C-peptide, AUC 0-12|||384.04|-507.32|
91519612|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.46|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.46
91519613|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.68|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.68
91706881|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.849|||||TWO_SIDED|95.0|-530.07|358.37|||||Comparison of C-peptide, AUC 0-12|||358.37|-530.07|
91706882|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.422|||||TWO_SIDED|95.0|-494.09|291.25|||||Comparison of C-peptide, AUC 0-12|||291.25|-494.09|
91706883|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.239|||||TWO_SIDED|95.0|-340.32|261.85|||||Comparison of C-peptide, iAUC 0-12|||261.85|-340.32|
91519614|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.61|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.61
91519615|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.55|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.55
91519616|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.46|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.46
91644312|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.725|||<|0.0001|TWO_SIDED|95.0|-0.965|-0.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.486|-0.965|<.0001
91644313|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.008|-0.571|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.571|-1.008|<.0001
91644314|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.833|||<|0.0001|TWO_SIDED|95.0|-1.069|-0.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.597|-1.069|<.0001
91644315|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.843|||<|0.0001|TWO_SIDED|95.0|-1.059|-0.627|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.627|-1.059|<.0001
91644316|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.52|||<|0.0001|TWO_SIDED|95.0|0.294|0.745|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.745|0.294|<.0001
91644317|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.37|||<|0.0001|TWO_SIDED|95.0|0.163|0.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.577|0.163|<.0001
91644318|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.628|||<|0.0001|TWO_SIDED|95.0|0.402|0.855|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.855|0.402|<.0001
91644319|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.464|||<|0.0001|TWO_SIDED|95.0|0.257|0.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.670|0.257|<.0001
91644320|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.053||||0.9984|TWO_SIDED|95.0|-0.2|0.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.306|-0.200|0.9984
91706884|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-117.435|||||TWO_SIDED|95.0|-429.61|194.74|||||Comparison of C-peptide, iAUC 0-12|||194.74|-429.61|
91706885|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-121.982|||||TWO_SIDED|95.0|-433.14|189.18|||||Comparison of C-peptide, iAUC 0-12|||189.18|-433.14|
91644321|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.173||||0.2491|TWO_SIDED|95.0|-0.405|0.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.058|-0.405|0.2491
91644322|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.054||||0.9977|TWO_SIDED|95.0|-0.304|0.195|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.195|-0.304|0.9977
91644323|NCT03692078|183180097|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.227||||0.0554|TWO_SIDED|95.0|-0.456|0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.003|-0.456|0.0554
91644324|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.294|||<|0.0001|TWO_SIDED|95.0|3.208|3.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.379|3.208|<.0001
91644325|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.262|||<|0.0001|TWO_SIDED|95.0|3.176|3.348|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.348|3.176|<.0001
91644326|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|3.039|3.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.202|3.039|<.0001
91644327|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.099|||<|0.0001|TWO_SIDED|95.0|3.017|3.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.181|3.017|<.0001
91644328|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.182|||<|0.0001|TWO_SIDED|95.0|3.1|3.264|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.264|3.100|<.0001
91644329|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.149|||<|0.0001|TWO_SIDED|95.0|3.066|3.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.231|3.066|<.0001
91519617|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.4|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.40
91644330|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.777|||<|0.0001|TWO_SIDED|95.0|2.673|2.881|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.881|2.673|<.0001
91644331|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.651|||<|0.0001|TWO_SIDED|95.0|2.546|2.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.756|2.546|<.0001
91644332|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.72|||<|0.0001|TWO_SIDED|95.0|2.618|2.823|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.823|2.618|<.0001
91644333|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.649|||<|0.0001|TWO_SIDED|95.0|2.544|2.753|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.753|2.544|<.0001
91644334|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.751|||<|0.0001|TWO_SIDED|95.0|2.651|2.851|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.851|2.651|<.0001
91644335|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.819|||<|0.0001|TWO_SIDED|95.0|2.718|2.919|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.919|2.718|<.0001
91644336|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.173||||0.0377|TWO_SIDED|95.0|-0.34|-0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.006|-0.340|0.0377
91644337|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.163||||0.0643|TWO_SIDED|95.0|-0.331|0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.006|-0.331|0.0643
91644338|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.112||||0.3875|TWO_SIDED|95.0|-0.279|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.056|-0.279|0.3875
91519618|NCT02130193|182913587|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.33|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.33
91644339|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.113||||0.3725|TWO_SIDED|95.0|-0.28|0.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.054|-0.280|0.3725
91644340|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.516|||<|0.0001|TWO_SIDED|95.0|-0.706|-0.327|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.327|-0.706|<.0001
91644341|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.611|||<|0.0001|TWO_SIDED|95.0|-0.802|-0.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.420|-0.802|<.0001
91644342|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.573|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.386|-0.760|<.0001
91644343|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.803|-0.423|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.423|-0.803|<.0001
91644344|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.369|||<|0.0001|TWO_SIDED|95.0|0.19|0.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.548|0.190|<.0001
91644345|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.28||||0.0003|TWO_SIDED|95.0|0.099|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|0.099|0.0003
91644346|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.431|||<|0.0001|TWO_SIDED|95.0|0.251|0.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.611|0.251|<.0001
91706886|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-81.016|||||TWO_SIDED|95.0|-356.07|194.03|||||Comparison of C-peptide, iAUC 0-12|||194.03|-356.07|
91706887|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.812|||||TWO_SIDED|95.0|-8.08|13.7|||||Comparison of GIP total, AUC 0-12|||13.70|-8.08|
91706888|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.023|||||TWO_SIDED|95.0|-8.27|14.32|||||Comparison of GIP total, AUC 0-12|||14.32|-8.27|
91706889|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.483|||||TWO_SIDED|95.0|0.23|22.74|||||Comparison of GIP total, AUC 0-12|||22.74|0.23|
91706890|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.093|||||TWO_SIDED|95.0|-17.04|2.86|||||Comparison of GIP total, AUC 0-12|||2.86|-17.04|
91706891|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-7.28|12.28|||||Comparison of GIP total, iAUC 0-12|||12.28|-7.28|
91519619|NCT02130193|182913591|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.013|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.013
91519620|NCT02130193|182913591|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.006|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.006
91519621|NCT02130193|182913591|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.003|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.003
91519622|NCT02130193|182913591|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.001
91519623|NCT02130193|182913591|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977|<|0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|<0.001
91519624|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|1.29||0.6|TWO_SIDED|95.0|-2.81|2.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 1 month. Data presented are for 95% equal-tailed credible intervals|||2.17|-2.81|0.60
91519625|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.58|STANDARD_DEVIATION|1.42||0.65|TWO_SIDED|95.0|-3.11|2.37||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 2 month. Data presented are for 95% equal-tailed credible intervals|||2.37|-3.11|0.65
91519626|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.46|STANDARD_DEVIATION|1.52||0.83|TWO_SIDED|95.0|-4.43|1.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 3 month. Data presented are for 95% equal-tailed credible intervals|||1.45|-4.43|0.83
91519627|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.2|STANDARD_DEVIATION|1.53||0.78|TWO_SIDED|95.0|-4.07|1.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 4 month. Data presented are for 95% equal-tailed credible intervals|||1.90|-4.07|0.78
91519628|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.96|STANDARD_DEVIATION|1.56||0.73|TWO_SIDED|95.0|-3.82|2.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 5 month. Data presented are for 95% equal-tailed credible intervals|||2.28|-3.82|0.73
91519629|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.93|STANDARD_DEVIATION|1.58||0.72|TWO_SIDED|95.0|-4.01|2.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 6 month. Data presented are for 95% equal-tailed credible intervals|||2.26|-4.01|0.72
91519630|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.0|STANDARD_DEVIATION|1.58||0.73|TWO_SIDED|95.0|-4.15|2.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.09|-4.15|0.73
91519631|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.48|STANDARD_DEVIATION|1.69||0.81|TWO_SIDED|95.0|-4.71|1.76||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.76|-4.71|0.81
91706892|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.526|||||TWO_SIDED|95.0|-6.61|13.67|||||Comparison of GIP total, iAUC 0-12|||13.67|-6.61|
91706893|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.934|||||TWO_SIDED|95.0|-2.17|18.04|||||Comparison of GIP total, iAUC 0-12|||18.04|-2.17|
91519632|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.23|STANDARD_DEVIATION|1.75||0.76|TWO_SIDED|95.0|-4.66|2.22||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 9 month. Data presented are for 95% equal-tailed credible intervals|||2.22|-4.66|0.76
91519633|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.26|STANDARD_DEVIATION|1.74||0.91|TWO_SIDED|95.0|-5.66|0.99||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.99|-5.66|0.91
91519634|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.05|STANDARD_DEVIATION|1.73||0.71|TWO_SIDED|95.0|-4.73|2.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 11 month. Data presented are for 95% equal-tailed credible intervals|||2.13|-4.73|0.71
91519635|NCT02130193|182913592|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.35|STANDARD_DEVIATION|1.74||0.78|TWO_SIDED|95.0|-4.77|2.04||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 12 month. Data presented are for 95% equal-tailed credible intervals|||2.04|-4.77|0.78
91581627|NCT02349425|183053228|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0025|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.6|-2.6|0.0025
91644347|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.33|||<|0.0001|TWO_SIDED|95.0|0.149|0.511|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.511|0.149|<.0001
91644348|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.026||||1|TWO_SIDED|95.0|-0.176|0.228|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.228|-0.176|1.0000
91644349|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.168||||0.1589|TWO_SIDED|95.0|-0.371|0.036|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.036|-0.371|0.1589
91644350|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.031||||0.9999|TWO_SIDED|95.0|-0.23|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.168|-0.230|0.9999
91644351|NCT03692078|183180099|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.17||||0.1453|TWO_SIDED|95.0|-0.372|0.032|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.032|-0.372|0.1453
91644352|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.085|||<|0.0001|TWO_SIDED|95.0|0.788|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.382|0.788|<.0001
91644353|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.104|||<|0.0001|TWO_SIDED|95.0|0.807|1.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.400|0.807|<.0001
91644354|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.606|||<|0.0001|TWO_SIDED|95.0|0.326|0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||0.886|0.326|<.0001
91706894|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.055|||||TWO_SIDED|95.0|-15.99|1.88|||||Comparison of GIP total, iAUC 0-12|||1.88|-15.99|
91706895|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.79|0.76|||||Comparison of GLP-1 active, AUC 0-12|||0.76|-0.79|
91519636|NCT02130193|182913596|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.278|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.278
91519637|NCT02130193|182913596|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.138|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.138
91519638|NCT02130193|182913596|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.05|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.05
91519639|NCT02130193|182913596|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.011|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.011
91519640|NCT02130193|182913596|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.002|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.002
91519641|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.62|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.62
91519642|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.64|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.64
91519643|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.81|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.81
91519644|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.77|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.77
91519645|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.71|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.71
91519646|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.7|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.70
91644355|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.476||||0.0011|TWO_SIDED|95.0|0.192|0.76|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||0.760|0.192|0.0011
91519647|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.74|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.74
91706896|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||||TWO_SIDED|95.0|-0.78|0.82|||||Comparison of GLP-1 active, AUC 0-12|||0.82|-0.78|
91519648|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.79|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.79
91519649|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.77|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.77
91519650|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.9|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.90
91706897|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.78|0.85|||||Comparison of GLP-1 active, AUC 0-12|||0.85|-0.78|
91706898|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.454|||||TWO_SIDED|95.0|2.74|4.17|||||Comparison of GLP-1 active, AUC 0-12|||4.17|2.74|
91706899|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.78|0.75|||||Comparison of GLP-1 active, iAUC 0-12|||0.75|-0.78|
91519651|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.66|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.66
91519652|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.74|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.74
91644356|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.505||||0.0006|TWO_SIDED|95.0|0.219|0.79|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||0.790|0.219|0.0006
91644357|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.775|||<|0.0001|TWO_SIDED|95.0|0.49|1.06|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.060|0.490|<.0001
91644358|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.116|||<|0.0001|TWO_SIDED|95.0|-2.472|-1.761|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.761|-2.472|<.0001
91644359|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.016|||<|0.0001|TWO_SIDED|95.0|-2.376|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.656|-2.376|<.0001
91644360|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.605|||<|0.0001|TWO_SIDED|95.0|-1.958|-1.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.253|-1.958|<.0001
91644361|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.642|||<|0.0001|TWO_SIDED|95.0|-2.003|-1.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.282|-2.003|<.0001
91644362|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.578|||<|0.0001|TWO_SIDED|95.0|-1.922|-1.234|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.234|-1.922|<.0001
91644363|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.726|||<|0.0001|TWO_SIDED|95.0|-2.074|-1.378|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.378|-2.074|<.0001
91706900|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.79|0.8|||||Comparison of GLP-1 active, iAUC 0-12|||0.80|-0.79|
91706901|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.79|0.83|||||Comparison of GLP-1 active, iAUC 0-12|||0.83|-0.79|
91706902|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.399|||||TWO_SIDED|95.0|2.69|4.11|||||Comparison of GLP-1 active, iAUC 0-12|||4.11|2.69|
91706903|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-2.06|2.17|||||Comparison of GLP-1 total, AUC 0-12|||2.17|-2.06|
91519653|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.43|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.43
91644364|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.479||||0.1579|TWO_SIDED|95.0|-1.054|0.097|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.097|-1.054|0.1579
91644365|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.628||||0.026|TWO_SIDED|95.0|-1.207|-0.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.048|-1.207|0.0260
91644366|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.58||||0.0483|TWO_SIDED|95.0|-1.158|-0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.003|-1.158|0.0483
91644367|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.329||||0.5842|TWO_SIDED|95.0|-0.906|0.249|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.249|-0.906|0.5842
91644368|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-3.201|||<|0.0001|TWO_SIDED|95.0|-3.856|-2.546|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.546|-3.856|<.0001
91644369|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.119|||<|0.0001|TWO_SIDED|95.0|-3.779|-2.46|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.460|-3.779|<.0001
91644370|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.338|-2.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.043|-3.338|<.0001
91644371|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.746|||<|0.0001|TWO_SIDED|95.0|-3.402|-2.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.090|-3.402|<.0001
91706904|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|||||TWO_SIDED|95.0|-1.97|2.42|||||Comparison of GLP-1 total, AUC 0-12|||2.42|-1.97|
91519654|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.45|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.45
91644372|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.184|||<|0.0001|TWO_SIDED|95.0|1.565|2.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.803|1.565|<.0001
91519655|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.67|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.67
91519656|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.62|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.62
91519657|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.55|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.55
91519658|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.55|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.55
91519659|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.59|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.59
91519660|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.65|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.65
91519661|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.63|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.63
91519662|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.81|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.81
91519663|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.52|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.52
91519664|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.6|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.60
91519665|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.24|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.24
91706905|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.835|||||TWO_SIDED|95.0|-0.35|4.02|||||Comparison of GLP-1 total, AUC 0-12|||4.02|-0.35|
91706906|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.629|||||TWO_SIDED|95.0|-3.56|0.3|||||Comparison of GLP-1 total, AUC 0-12|||0.30|-3.56|
91519666|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.28|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.28
91519667|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.5|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.50
91706907|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||||TWO_SIDED|95.0|-1.7|1.86|||||Comparison of GLP-1 total, iAUC 0-12|||1.86|-1.70|
91706908|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|||||TWO_SIDED|95.0|-1.56|2.13|||||Comparison of GLP-1 total, iAUC 0-12|||2.13|-1.56|
91519668|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.43|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.43
91581628|NCT02349425|183053228|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.005|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.8|0.0050
91644373|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.202|||<|0.0001|TWO_SIDED|95.0|1.576|2.828|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.828|1.576|<.0001
91644374|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.083|||<|0.0001|TWO_SIDED|95.0|1.461|2.704|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.704|1.461|<.0001
91644375|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.501|||<|0.0001|TWO_SIDED|95.0|1.876|3.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.126|1.876|<.0001
91644376|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.538||||0.2085|TWO_SIDED|95.0|-1.231|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.154|-1.231|0.2085
91644377|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.289||||0.8557|TWO_SIDED|95.0|-0.988|0.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.410|-0.988|0.8557
91644378|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.027||||1|TWO_SIDED|95.0|-0.713|0.658|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.658|-0.713|1.0000
91644379|NCT03692078|183180101|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.084||||1|TWO_SIDED|95.0|-0.612|0.78|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.780|-0.612|1.0000
91644380|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.081|||<|0.0001|TWO_SIDED|95.0|0.679|1.484|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.484|0.679|<.0001
91706909|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|-1.08|2.6|||||Comparison of GLP-1 total, iAUC 0-12|||2.60|-1.08|
91706910|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|||||TWO_SIDED|95.0|-2.96|0.29|||||Comparison of GLP-1 total, iAUC 0-12|||0.29|-2.96|
91706911|NCT01119846|183307987|SUPERIORITY||Mean Difference (Final Values)|0.962|||||TWO_SIDED|95.0|-4.26|6.18|||||Comparison of Glucagon, AUC 0-12|||6.18|-4.26|
91519669|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.37|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.37
91706912|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.067|||||TWO_SIDED|95.0|-2.56|8.69|||||Comparison of Glucagon, AUC 0-12|||8.69|-2.56|
91644381|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.309|||<|0.0001|TWO_SIDED|95.0|0.902|1.716|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.716|0.902|<.0001
91644382|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.996|||<|0.0001|TWO_SIDED|95.0|0.615|1.377|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.377|0.615|<.0001
91644383|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.728||||0.0003|TWO_SIDED|95.0|0.339|1.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.116|0.339|0.0003
91644384|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.987|||<|0.0001|TWO_SIDED|95.0|0.593|1.381|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.381|0.593|<.0001
91644385|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.865|||<|0.0001|TWO_SIDED|95.0|0.475|1.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.254|0.475|<.0001
91644386|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.436||||0.0768|TWO_SIDED|95.0|-0.047|0.92|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.920|-0.047|0.0768
91644387|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.091||||0.7155|TWO_SIDED|95.0|-0.4|0.583|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.583|-0.400|0.7155
91644388|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.237||||0.3282|TWO_SIDED|95.0|-0.239|0.713|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.713|-0.239|0.3282
91644389|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.23||||0.3578|TWO_SIDED|95.0|-0.722|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.262|-0.722|0.3578
91706913|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|||||TWO_SIDED|95.0|-2.98|8.01|||||Comparison of Glucagon, AUC 0-12|||8.01|-2.98|
91706914|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.714|||||TWO_SIDED|95.0|-5.56|4.13|||||Comparison of Glucagon, AUC 0-12|||4.13|-5.56|
91644390|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.338||||0.1638|TWO_SIDED|95.0|-0.138|0.814|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.814|-0.138|0.1638
91644391|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.8384|TWO_SIDED|95.0|-0.533|0.433|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.433|-0.533|0.8384
91644392|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.086||||1|TWO_SIDED|95.0|-0.869|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.869|1.0000
91644393|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.581||||0.2808|TWO_SIDED|95.0|-1.377|0.214|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.214|-1.377|0.2808
91644394|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.095||||1|TWO_SIDED|95.0|-0.887|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.887|1.0000
91644395|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.444||||0.6018|TWO_SIDED|95.0|-1.237|0.349|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.349|-1.237|0.6018
91644396|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.645||||0.2935|TWO_SIDED|95.0|-1.536|0.246|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.246|-1.536|0.2935
91644397|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.218||||0.0023|TWO_SIDED|95.0|-2.12|-0.315|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.315|-2.120|0.0023
91706915|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.866|||||TWO_SIDED|95.0|-6.4|0.67|||||Comparison of Glucagon, iAUC 0-12|||0.67|-6.40|
91706916|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.865|||||TWO_SIDED|95.0|-4.68|2.95|||||Comparison of Glucagon, iAUC 0-12|||2.95|-4.68|
91706917|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.436|||||TWO_SIDED|95.0|-4.16|3.29|||||Comparison of Glucagon, iAUC 0-12|||3.29|-4.16|
91706918|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.573|||||TWO_SIDED|95.0|-4.86|1.71|||||Comparison of Glucagon, iAUC 0-12|||1.71|-4.86|
91519670|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.38|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.38
91644398|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.844||||0.0669|TWO_SIDED|95.0|-1.723|0.035|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||0.035|-1.723|0.0669
91644399|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.539|||<|0.0001|TWO_SIDED|95.0|-2.438|-0.64|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.640|-2.438|<.0001
91644400|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.658||||0.212|TWO_SIDED|95.0|-0.192|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.192|0.2120
91644401|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.778||||0.0993|TWO_SIDED|95.0|-0.087|1.642|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.642|-0.087|0.0993
91644402|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.649||||0.2347|TWO_SIDED|95.0|-0.211|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.211|0.2347
91644403|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.915||||0.032|TWO_SIDED|95.0|0.052|1.778|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.778|0.052|0.0320
91644404|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.099||||1|TWO_SIDED|95.0|-0.849|1.047|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||1.047|-0.849|1.0000
91644405|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.141||||0.9999|TWO_SIDED|95.0|-0.82|1.103|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||1.103|-0.820|0.9999
91644406|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||1|TWO_SIDED|95.0|-1.038|0.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.837|-1.038|1.0000
91706919|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.74|||||TWO_SIDED|95.0|-168.38|118.9|||||Comparison of Insulin, AUC 0-13|||118.90|-168.38|
91706920|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.229|||||TWO_SIDED|95.0|-161.16|136.7|||||Comparison of Insulin, AUC 0-13|||136.70|-161.16|
91519671|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.43|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.43
91519672|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.51|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.51
91519673|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.5|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.50
91519674|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.7|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.70
91519675|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.38|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.38
91519676|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.45|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.45
91519677|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.11|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.11
91519678|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.15|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.15
91519679|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.32|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.32
91519680|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.28|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.28
91519681|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.23|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.23
91519682|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.24|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.24
91519683|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.29|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.29
91519684|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.36|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.36
91519685|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.35|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.35
91519686|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.57|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.57
91519687|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.25|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.25
91519688|NCT02130193|182913597|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.32|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.32
91644407|NCT03692078|183180103|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.18||||0.9995|TWO_SIDED|95.0|-1.139|0.779|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.779|-1.139|0.9995
91644408|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|2.964|3.276|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.276|2.964|<.0001
91644409|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.141|||<|0.0001|TWO_SIDED|95.0|2.953|3.328|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.328|2.953|<.0001
91644410|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.658|||<|0.0001|TWO_SIDED|95.0|2.511|2.806|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.806|2.511|<.0001
91644411|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.638|||<|0.0001|TWO_SIDED|95.0|2.458|2.817|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.817|2.458|<.0001
91644412|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.754|||<|0.0001|TWO_SIDED|95.0|2.604|2.903|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.903|2.604|<.0001
91644413|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.652|||<|0.0001|TWO_SIDED|95.0|2.471|2.832|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.832|2.471|<.0001
91644414|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.703|||<|0.0001|TWO_SIDED|95.0|1.517|1.889|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.889|1.517|<.0001
91706921|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.628|||||TWO_SIDED|95.0|-158.07|138.81|||||Comparison of Insulin, AUC 0-13|||138.81|-158.07|
91706922|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.936|||||TWO_SIDED|95.0|-198.15|64.28|||||Comparison of Insulin, AUC 0-13|||64.28|-198.15|
91706923|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.042|||||TWO_SIDED|95.0|-150.57|78.48|||||Comparison of Insulin, iAUC 0-13|||78.48|-150.57|
91519689|NCT02130193|182913598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.477|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 1.0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.477
91706924|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.525|||||TWO_SIDED|95.0|-141.27|96.22|||||Comparison of Insulin, iAUC 0-13|||96.22|-141.27|
91644415|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.637|||<|0.0001|TWO_SIDED|95.0|1.41|1.865|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.865|1.410|<.0001
91644416|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.656|||<|0.0001|TWO_SIDED|95.0|1.472|1.839|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.839|1.472|<.0001
91644417|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.485|||<|0.0001|TWO_SIDED|95.0|1.259|1.711|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.711|1.259|<.0001
91644418|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.713|||<|0.0001|TWO_SIDED|95.0|1.532|1.895|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.895|1.532|<.0001
91644419|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.617|||<|0.0001|TWO_SIDED|95.0|1.397|1.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.837|1.397|<.0001
91644420|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.462||||0.0003|TWO_SIDED|95.0|-0.766|-0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.158|-0.766|0.0003
91644421|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.503||||0.0018|TWO_SIDED|95.0|-0.867|-0.139|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.139|-0.867|0.0018
91644422|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.366||||0.0089|TWO_SIDED|95.0|-0.67|-0.062|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.062|-0.670|0.0089
91706925|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|||||TWO_SIDED|95.0|-140.36|96.36|||||Comparison of Insulin, iAUC 0-13|||96.36|-140.36|
91706926|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.324|||||TWO_SIDED|95.0|-170.95|38.3|||||Comparison of Insulin, iAUC 0-13|||38.30|-170.95|
91706927|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.982|||||TWO_SIDED|95.0|-2.66|14.62|||||Comparison of PYY total, AUC 0-12|||14.62|-2.66|
91706928|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.908|||||TWO_SIDED|95.0|-0.05|17.86|||||Comparison of PYY total, AUC 0-12|||17.86|-0.05|
91706929|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.317|||||TWO_SIDED|95.0|5.39|23.24|||||Comparison of PYY total, AUC 0-12|||23.24|5.39|
91706930|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.33|2.45|||||Comparison of PYY total, AUC 0-12|||2.45|-13.33|
91644423|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.0025|TWO_SIDED|95.0|-0.851|-0.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.126|-0.851|0.0025
91644424|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.417|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.072|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.072|-1.762|<.0001
91644425|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.504|||<|0.0001|TWO_SIDED|95.0|-1.916|-1.091|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.091|-1.916|<.0001
91644426|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.464|||<|0.0001|TWO_SIDED|95.0|-1.804|-1.125|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.125|-1.804|<.0001
91644427|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.656|||<|0.0001|TWO_SIDED|95.0|-2.065|-1.247|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.247|-2.065|<.0001
91644428|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.945|||<|0.0001|TWO_SIDED|95.0|0.617|1.273|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.273|0.617|<.0001
91644429|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.021|||<|0.0001|TWO_SIDED|95.0|0.628|1.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.413|0.628|<.0001
91644430|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.041|||<|0.0001|TWO_SIDED|95.0|0.712|1.369|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.369|0.712|<.0001
91644431|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.035|||<|0.0001|TWO_SIDED|95.0|0.644|1.426|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.426|0.644|<.0001
91706931|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.999|||||TWO_SIDED|95.0|-1.87|11.87|||||Comparison of PYY total, iAUC 0-12|||11.87|-1.87|
91644432|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.01||||1|TWO_SIDED|95.0|-0.376|0.355|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.355|-0.376|1.0000
91644433|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.02||||1|TWO_SIDED|95.0|-0.417|0.457|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.457|-0.417|1.0000
91644434|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||0.9999|TWO_SIDED|95.0|-0.418|0.303|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.303|-0.418|0.9999
91644435|NCT03692078|183180105|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.132||||0.9669|TWO_SIDED|95.0|-0.566|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.301|-0.566|0.9669
91644436|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.442|||<|0.0001|TWO_SIDED|95.0|-1.604|-1.279|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-1.279|-1.604|<.0001
91644437|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.413|||<|0.0001|TWO_SIDED|95.0|-1.576|-1.251|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-1.251|-1.576|<.0001
91644438|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.754|||<|0.0001|TWO_SIDED|95.0|-1.907|-1.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-1.600|-1.907|<.0001
91644439|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.816|||<|0.0001|TWO_SIDED|95.0|-1.972|-1.659|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-1.659|-1.972|<.0001
91644440|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.654|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-1.498|-1.810|<.0001
91706932|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.909|||||TWO_SIDED|95.0|-0.22|14.03|||||Comparison of PYY total, iAUC 0-12|||14.03|-0.22|
91644441|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.829|||<|0.0001|TWO_SIDED|95.0|-1.986|-1.673|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-1.673|-1.986|<.0001
91644442|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.184|||<|0.0001|TWO_SIDED|95.0|-2.379|-1.989|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.989|-2.379|<.0001
91644443|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.27|||<|0.0001|TWO_SIDED|95.0|-2.468|-2.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-2.071|-2.468|<.0001
91644444|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.413|||<|0.0001|TWO_SIDED|95.0|-2.607|-2.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-2.219|-2.607|<.0001
91644445|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.349|||<|0.0001|TWO_SIDED|95.0|-2.549|-2.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-2.149|-2.549|<.0001
91644446|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.227|||<|0.0001|TWO_SIDED|95.0|-2.416|-2.038|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-2.038|-2.416|<.0001
91644447|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.154|||<|0.0001|TWO_SIDED|95.0|-2.345|-1.962|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.962|-2.345|<.0001
91644448|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.312||||0.0552|TWO_SIDED|95.0|-0.628|0.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.004|-0.628|0.0552
91706933|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.036|||||TWO_SIDED|95.0|1.93|16.14|||||Comparison of PYY total, iAUC 0-12|||16.14|1.93|
91706934|NCT01119846|183307987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.39|||||TWO_SIDED|95.0|-12.67|-0.11|||||Comparison of PYY total, iAUC 0-12|||-0.11|-12.67|
91706935|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.69|1.56|||||Comparison of AUC 0-3|||1.56|-2.69|
91706936|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.846|||||TWO_SIDED|95.0|-3.05|1.36|||||Comparison of AUC 0-3|||1.36|-3.05|
91706937|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.175|||||TWO_SIDED|95.0|-3.37|1.02|||||Comparison of AUC 0-3|||1.02|-3.37|
91706938|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.617|||||TWO_SIDED|95.0|-2.56|1.33|||||Comparison of AUC 0-3|||1.33|-2.56|
91644449|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.402||||0.0055|TWO_SIDED|95.0|-0.722|-0.083|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.083|-0.722|0.0055
91644450|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.212||||0.3834|TWO_SIDED|95.0|-0.53|0.105|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.105|-0.530|0.3834
91644451|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.416||||0.0033|TWO_SIDED|95.0|-0.734|-0.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.099|-0.734|0.0033
91644452|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.743|||<|0.0001|TWO_SIDED|95.0|-1.103|-0.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.382|-1.103|<.0001
91644453|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.857|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.493|-1.220|<.0001
91644454|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.327|-0.616|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.616|-1.327|<.0001
91644455|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.298|-0.574|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.574|-1.298|<.0001
91644456|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.473||||0.0016|TWO_SIDED|95.0|0.133|0.813|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.813|0.133|0.0016
91644457|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.338||||0.0582|TWO_SIDED|95.0|-0.007|0.683|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.683|-0.007|0.0582
91706939|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.626|||||TWO_SIDED|95.0|-1.64|0.39|||||Comparison of iAUC 0-3|||0.39|-1.64|
91706940|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.956|||||TWO_SIDED|95.0|-2.01|0.09|||||Comparison of iAUC 0-3|||0.09|-2.01|
91644458|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.573|||<|0.0001|TWO_SIDED|95.0|0.232|0.914|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.914|0.232|<.0001
91644459|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.324||||0.0745|TWO_SIDED|95.0|-0.02|0.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.668|-0.020|0.0745
91644460|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||1|TWO_SIDED|95.0|-0.337|0.422|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.422|-0.337|1.0000
91644461|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.116||||0.9759|TWO_SIDED|95.0|-0.501|0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.268|-0.501|0.9759
91644462|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.186||||0.7128|TWO_SIDED|95.0|-0.565|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.192|-0.565|0.7128
91644463|NCT03692078|183180107|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.195||||0.6816|TWO_SIDED|95.0|-0.582|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.192|-0.582|0.6816
91644464|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.948|||<|0.0001|TWO_SIDED|95.0|-1.146|-0.75|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-0.750|-1.146|<.0001
91644465|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.019|||<|0.0001|TWO_SIDED|95.0|-1.242|-0.796|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-0.796|-1.242|<.0001
91644466|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.172|||<|0.0001|TWO_SIDED|95.0|-1.358|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-0.986|-1.358|<.0001
91706941|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.103|||||TWO_SIDED|95.0|-2.15|-0.06|||||Comparison of iAUC 0-3|||-0.06|-2.15|
91706942|NCT01119846|183307988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||||TWO_SIDED|95.0|-1.91|-0.07|||||Comparison of iAUC 0-3|||-0.07|-1.91|
91519690|NCT02130193|182913598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.343|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.9 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.343
91519691|NCT02130193|182913598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.221|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.8 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.221
91519692|NCT02130193|182913598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.116|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.116
91519693|NCT02130193|182913598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.052|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.6 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.052
91519694|NCT02130193|182913599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.212|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.212
91519695|NCT02130193|182913599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.111|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.111
91519696|NCT02130193|182913599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.049|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.049
91519697|NCT02130193|182913599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.012|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.012
91519698|NCT02130193|182913599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.001|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.001
91519699|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.64|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.64
91519700|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.75|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.75
91519701|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.77|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.77
91519702|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.74|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.74
91519703|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.67|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.67
91519704|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.69|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.69
91519705|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.72|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.72
91519706|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.71|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.71
91519707|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.66|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.66
91519708|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.84|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.84
91581629|NCT02349425|183053229|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.0506|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.0|-1.4|0.0506
91644467|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.409|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-0.983|-1.409|<.0001
91644468|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.049|||<|0.0001|TWO_SIDED|95.0|-1.239|-0.859|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-0.859|-1.239|<.0001
91644469|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.414|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-0.986|-1.414|<.0001
91644470|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.337|||<|0.0001|TWO_SIDED|95.0|-1.574|-1.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.099|-1.574|<.0001
91644471|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.345|||<|0.0001|TWO_SIDED|95.0|-1.616|-1.075|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.075|-1.616|<.0001
91644472|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.685|-1.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.219|-1.685|<.0001
91644473|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.608|-1.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.071|-1.608|<.0001
91644474|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.348|||<|0.0001|TWO_SIDED|95.0|-1.577|-1.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.118|-1.577|<.0001
91644475|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.227|||<|0.0001|TWO_SIDED|95.0|-1.488|-0.966|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.966|-1.488|<.0001
91706943|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|152.962|||||TWO_SIDED|95.0|-200.57|506.49|||||Comparison of C-peptide, AUC 0-2|||506.49|-200.57|
91706944|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.866|||||TWO_SIDED|95.0|-252.69|480.42|||||Comparison of C-peptide, AUC 0-2|||480.42|-252.69|
91644476|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5646|TWO_SIDED|95.0|-0.607|0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.160|-0.607|0.5646
91644477|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.177||||0.8765|TWO_SIDED|95.0|-0.609|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.254|-0.609|0.8765
91644478|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9954|TWO_SIDED|95.0|-0.488|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.287|-0.488|0.9954
91644479|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.181||||0.8665|TWO_SIDED|95.0|-0.613|0.252|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.252|-0.613|0.8665
91644480|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.389||||0.1165|TWO_SIDED|95.0|-0.829|0.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.052|-0.829|0.1165
91644481|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.326||||0.3896|TWO_SIDED|95.0|-0.821|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||0.168|-0.821|0.3896
91644482|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.504||||0.0122|TWO_SIDED|95.0|-0.934|-0.074|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.074|-0.934|0.0122
91644483|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32||||0.3938|TWO_SIDED|95.0|-0.807|0.167|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||0.167|-0.807|0.3938
91644484|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.176||||0.8501|TWO_SIDED|95.0|-0.237|0.589|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.589|-0.237|0.8501
91706945|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.474|||||TWO_SIDED|95.0|-250.89|479.83|||||Comparison of C-peptide, AUC 0-2|||479.83|-250.89|
91706946|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|136.638|||||TWO_SIDED|95.0|-186.32|459.6|||||Comparison of C-peptide, AUC 0-2|||459.60|-186.32|
91644485|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.031||||1|TWO_SIDED|95.0|-0.435|0.496|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.496|-0.435|1.0000
91644486|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.299||||0.2928|TWO_SIDED|95.0|-0.117|0.715|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.715|-0.117|0.2928
91644487|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.027||||1|TWO_SIDED|95.0|-0.439|0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.493|-0.439|1.0000
91644488|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.453|0.475|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.475|-0.453|1.0000
91644489|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.118||||0.9966|TWO_SIDED|95.0|-0.64|0.403|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.403|-0.640|0.9966
91644490|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.9976|TWO_SIDED|95.0|-0.56|0.352|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.352|-0.560|0.9976
91644491|NCT03692078|183180109|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.112||||0.9976|TWO_SIDED|95.0|-0.628|0.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.404|-0.628|0.9976
91706947|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|163.622|||||TWO_SIDED|95.0|-127.31|454.55|||||Comparison of C-peptide, iAUC 0-2|||454.55|-127.31|
91706948|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.074|||||TWO_SIDED|95.0|-243.57|359.72|||||Comparison of C-peptide, iAUC 0-2|||359.72|-243.57|
91706949|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.341|||||TWO_SIDED|95.0|-222.32|379.0|||||Comparison of C-peptide, iAUC 0-2|||379.00|-222.32|
91519709|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.65|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.65
91519710|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.71|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.71
91519711|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.13|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.13
91706950|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.044|||||TWO_SIDED|95.0|-108.73|422.82|||||Comparison of C-peptide, iAUC 0-2|||422.82|-108.73|
91644492|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|180.0|||<|0.0001|TWO_SIDED|95.0|164.9|195.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||195.2|164.9|<.0001
91644493|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|181.1|||<|0.0001|TWO_SIDED|95.0|165.9|196.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||196.2|165.9|<.0001
91644494|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|132.3|||<|0.0001|TWO_SIDED|95.0|117.2|147.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||147.5|117.2|<.0001
91644495|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|137.3|||<|0.0001|TWO_SIDED|95.0|122.1|152.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||152.5|122.1|<.0001
91644496|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|136.8|||<|0.0001|TWO_SIDED|95.0|122.0|151.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||151.7|122.0|<.0001
91644497|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|150.8|||<|0.0001|TWO_SIDED|95.0|136.0|165.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||165.7|136.0|<.0001
91644498|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|43.2|||<|0.0001|TWO_SIDED|95.0|25.1|61.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||61.4|25.1|<.0001
91644499|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|61.7|||<|0.0001|TWO_SIDED|95.0|43.2|80.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||80.1|43.2|<.0001
91644500|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|36.9|||<|0.0001|TWO_SIDED|95.0|18.6|55.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||55.1|18.6|<.0001
91706951|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.539|||||TWO_SIDED|95.0|-4.79|17.87|||||Comparison of GIP total, AUC 0-2|||17.87|-4.79|
91644501|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|35.5||||0.0002|TWO_SIDED|95.0|16.7|54.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||54.3|16.7|0.0002
91644502|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|38.8|||<|0.0001|TWO_SIDED|95.0|19.9|57.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||57.6|19.9|<.0001
91644503|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|44.9|||<|0.0001|TWO_SIDED|95.0|26.0|63.8|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||63.8|26.0|<.0001
91644504|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-47.7||||0.0002|TWO_SIDED|95.0|-78.0|-17.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-17.4|-78.0|0.0002
91644505|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-43.8||||0.0009|TWO_SIDED|95.0|-74.1|-13.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-13.4|-74.1|0.0009
91644506|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-43.2||||0.0009|TWO_SIDED|95.0|-73.2|-13.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-13.3|-73.2|0.0009
91644507|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-30.2||||0.0466|TWO_SIDED|95.0|-60.2|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.3|-60.2|0.0466
91644508|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-136.8|||<|0.0001|TWO_SIDED|95.0|-170.4|-103.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-103.3|-170.4|<.0001
91644509|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-119.4|||<|0.0001|TWO_SIDED|95.0|-153.3|-85.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-85.5|-153.3|<.0001
91706952|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.095|||||TWO_SIDED|95.0|-7.65|15.84|||||Comparison of GIP total, AUC 0-2|||15.84|-7.65|
91644510|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-143.2|||<|0.0001|TWO_SIDED|95.0|-176.6|-109.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-109.7|-176.6|<.0001
91644511|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-145.6|||<|0.0001|TWO_SIDED|95.0|-179.7|-111.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-111.4|-179.7|<.0001
91644512|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|93.6|||<|0.0001|TWO_SIDED|95.0|60.0|127.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||127.2|60.0|<.0001
91644513|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|92.4|||<|0.0001|TWO_SIDED|95.0|58.8|126.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||126.1|58.8|<.0001
91644514|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|98.1|||<|0.0001|TWO_SIDED|95.0|64.6|131.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||131.5|64.6|<.0001
91644515|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|106.0|||<|0.0001|TWO_SIDED|95.0|72.5|139.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||139.4|72.5|<.0001
91644516|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|4.5||||1|TWO_SIDED|95.0|-32.0|40.9|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||40.9|-32.0|1.0000
91706953|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.033|||||TWO_SIDED|95.0|1.33|24.74|||||Comparison of GIP total, AUC 0-2|||24.74|1.33|
91644517|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|16.8||||0.7714|TWO_SIDED|95.0|-20.0|53.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||53.5|-20.0|0.7714
91706954|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.824|||||TWO_SIDED|95.0|-13.17|7.52|||||Comparison of GIP total, AUC 0-2|||7.52|-13.17|
91706955|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.227|||||TWO_SIDED|95.0|-3.47|15.93|||||Comparison of GIP total, iAUC 0-2|||15.93|-3.47|
91706956|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||||TWO_SIDED|95.0|-5.46|14.65|||||Comparison of GIP total, iAUC 0-2|||14.65|-5.46|
91706957|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.484|||||TWO_SIDED|95.0|-0.54|19.51|||||Comparison of GIP total, iAUC 0-2|||19.51|-0.54|
91644518|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-1.9||||1|TWO_SIDED|95.0|-38.3|34.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||34.5|-38.3|1.0000
91644519|NCT03692078|183180111|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-9.4||||0.9926|TWO_SIDED|95.0|-46.4|27.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||27.6|-46.4|0.9926
91644520|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.872|||<|0.0001|TWO_SIDED|95.0|1.81|1.935|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.935|1.810|<.0001
91644521|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.913|||<|0.0001|TWO_SIDED|95.0|1.851|1.976|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.976|1.851|<.0001
91644522|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.467|||<|0.0001|TWO_SIDED|95.0|1.408|1.525|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.525|1.408|<.0001
91644523|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.493|||<|0.0001|TWO_SIDED|95.0|1.434|1.551|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.551|1.434|<.0001
91644524|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.55|||<|0.0001|TWO_SIDED|95.0|1.49|1.609|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.609|1.490|<.0001
91644525|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.594|||<|0.0001|TWO_SIDED|95.0|1.533|1.654|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.654|1.533|<.0001
91644526|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.557|||<|0.0001|TWO_SIDED|95.0|0.482|0.631|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.631|0.482|<.0001
91706958|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.786|||||TWO_SIDED|95.0|-11.65|6.08|||||Comparison of GIP total, iAUC 0-2|||6.08|-11.65|
91706959|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|||||TWO_SIDED|95.0|-0.38|0.52|||||Comparison of GLP-1 active, AUC 0-2|||0.52|-0.38|
91644527|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.589|||<|0.0001|TWO_SIDED|95.0|0.514|0.665|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.665|0.514|<.0001
91644528|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.533|||<|0.0001|TWO_SIDED|95.0|0.461|0.605|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.605|0.461|<.0001
91644529|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.588|||<|0.0001|TWO_SIDED|95.0|0.514|0.662|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.662|0.514|<.0001
91644530|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.508|0.652|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.652|0.508|<.0001
91644531|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.507|0.653|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.653|0.507|<.0001
91644532|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.406|||<|0.0001|TWO_SIDED|95.0|-0.526|-0.285|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.285|-0.526|<.0001
91644533|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.541|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.300|-0.541|<.0001
91644534|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.323|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.201|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.201|-0.444|<.0001
91644535|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.442|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.198|-0.442|<.0001
91706960|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|||||TWO_SIDED|95.0|-0.21|0.72|||||Comparison of GLP-1 active, AUC 0-2|||0.72|-0.21|
91706961|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.42|0.51|||||Comparison of GLP-1 active, AUC 0-2|||0.51|-0.42|
91706962|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.694|||||TWO_SIDED|95.0|2.28|3.11|||||Comparison of GLP-1 active, AUC 0-2|||3.11|2.28|
91644536|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.453|-1.178|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.178|-1.453|<.0001
91644537|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.324|||<|0.0001|TWO_SIDED|95.0|-1.463|-1.186|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.186|-1.463|<.0001
91644538|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.473|-1.205|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.205|-1.473|<.0001
91644539|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.325|||<|0.0001|TWO_SIDED|95.0|-1.461|-1.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.190|-1.461|<.0001
91644540|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.887|||<|0.0001|TWO_SIDED|95.0|0.757|1.016|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.016|0.757|<.0001
91644541|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.912|||<|0.0001|TWO_SIDED|95.0|0.782|1.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.043|0.782|<.0001
91644542|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.97|||<|0.0001|TWO_SIDED|95.0|0.839|1.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.100|0.839|<.0001
91644543|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.013|||<|0.0001|TWO_SIDED|95.0|0.882|1.145|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.145|0.882|<.0001
91644544|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.023||||0.9999|TWO_SIDED|95.0|-0.168|0.122|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.122|-0.168|0.9999
91706963|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.36|0.5|||||Comparison of GLP-1 active, iAUC 0-2|||0.50|-0.36|
91706964|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|||||TWO_SIDED|95.0|-0.2|0.69|||||Comparison of GLP-1 active, iAUC 0-2|||0.69|-0.20|
91644545|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.009||||1|TWO_SIDED|95.0|-0.138|0.155|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.155|-0.138|1.0000
91519712|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.27|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.27
91644546|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.047||||0.9577|TWO_SIDED|95.0|-0.189|0.095|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.095|-0.189|0.9577
91644547|NCT03692078|183180113|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.008||||1|TWO_SIDED|95.0|-0.136|0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.152|-0.136|1.0000
91644548|NCT01339858|183180123|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
91644549|NCT00996632|183180131|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that drainage volumes are not different||||<0.05
91644550|NCT00996632|183180132|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that Stay in Hospital Days are not different||||0.05
91644551|NCT02861534|183180142|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.269|TWO_SIDED|95.0|0.81|1.06|||Cox proportional hazard model|||||1.06|0.81|0.269
91644552|NCT02861534|183180143|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.048|TWO_SIDED|95.0|0.81|1.0|||Cox proportional hazard model|||||1.00|0.81|0.048
91644553|NCT02861534|183180144|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.019|TWO_SIDED|95.0|0.82|0.98|||Cox proportional hazard model|||||0.98|0.82|0.019
91644554|NCT02861534|183180145|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.023|TWO_SIDED|95.0|0.84|0.99|||Andersen-Gill model|||||0.99|0.84|0.023
91644555|NCT02861534|183180146|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.021|TWO_SIDED|95.0|0.83|0.98|||Cox proportional hazard model|||||0.98|0.83|0.021
91644556|NCT02861534|183180147|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.377|TWO_SIDED|95.0|0.84|1.07|||Cox proportional hazard model|||||1.07|0.84|0.377
91706965|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|||||TWO_SIDED|95.0|-0.41|0.47|||||Comparison of GLP-1 active, iAUC 0-2|||0.47|-0.41|
91644557|NCT02861534|183180150|OTHER||Difference in Percentage|1.2||||0.121|TWO_SIDED|95.0|-0.3|2.8|||Miettinen & Nurminen method|||||2.8|-0.3|0.121
91644558|NCT02861534|183180151|OTHER||Difference in Percentage|0.6||||0.303|TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen method|||||1.6|-0.5|0.303
91644559|NCT01211873|183180172|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91644560|NCT01211873|183180173|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91644561|NCT01211873|183180173|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91644562|NCT01211873|183180174|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91644563|NCT01211873|183180174|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91644564|NCT01393626|183180197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86||||0.3249|TWO_SIDED|95.0|-7.64|21.36|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||21.36|-7.64|0.3249
91644565|NCT01393626|183180197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||0.3916|TWO_SIDED|95.0|-8.09|20.8|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||20.80|-8.09|0.3916
91644566|NCT02426125|183180217|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.0118|TWO_SIDED|95.0|0.607|0.943||Stratified|Log Rank||Stratified|||0.943|0.607|0.0118
91644567|NCT02426125|183180218|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.2461|TWO_SIDED|95.0|0.724|1.086||Stratified|Log Rank||Stratified|||1.086|0.724|0.2461
91644568|NCT02426125|183180221|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.189|TWO_SIDED|95.0|0.473|1.158|||Log Rank|||||1.158|0.473|0.189
91644569|NCT02426125|183180222|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.357|TWO_SIDED|95.0|0.663|1.167||Stratified|Log Rank||Stratified|Global health status/QoL||1.167|0.663|0.357
91644570|NCT00077766|183180230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 90% power assuming that the true difference between the RO0503821 group and darbepoetin was not larger than 0.3 g/dL.|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.1162|<|0.0001|TWO_SIDED|95.0|-0.049|0.408||The p-value for the non-inferiority test was derived using ANCOVA.|ANCOVA, CI for difference between groups|Degrees of Freedom : 246|Difference between groups based on the adjusted means derived from the ANCOVA model.|RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was \> or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.||0.408|-0.049|< 0.0001
91644571|NCT00118209|183180273|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6519|TWO_SIDED|95.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6519
91644572|NCT00118209|183180274|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91644573|NCT00118209|183180275|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6414|TWO_SIDED|95.0|0.75|1.59|||Log Rank|||||1.59|0.75|0.6414
91644574|NCT01418365|183180277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|0.979|||||TWO_SIDED|90.0|0.961|0.998|||ANOVA|||||0.998|0.961|
91644575|NCT01418365|183180278|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.993|||||TWO_SIDED|90.0|0.951|1.04|||ANOVA|||||1.04|0.951|
91644576|NCT03226366|183180279|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.29|TWO_SIDED|95.0|-20.4|6.1|||Regression, Linear||Change in emergency department door-to-antibiotic time (minutes) based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-antibiotic time after versus before intervention implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||6.1|-20.4|0.29
91644577|NCT03226366|183180280|SUPERIORITY||Odds Ratio (OR)|0.81||||0.72|TWO_SIDED|95.0|0.25|2.61|||Regression, Logistic||Odds ratio for hospital mortality after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||2.61|0.25|0.72
91644578|NCT03226366|183180281|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.26|TWO_SIDED|95.0|-25.9|7.0|||Regression, Linear||Change in emergency department length of stay (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||7.0|-25.9|0.26
91644579|NCT03226366|183180282|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.55|TWO_SIDED|95.0|-3.3|1.8|||Regression, Linear||Estimated change in emergency department door-to-physician evaluation time (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||1.8|-3.3|0.55
91644580|NCT02180659|183180295|NON_INFERIORITY|"For the primary efficacy variable, a test of non-inferiority of Probuphine (active) versus SL BPN (control) responders was conducted. A non-inferiority margin of 20% was employed to define noninferiority.~A Confidence Interval (CI) for the difference in proportions was calculated, and non-inferiority was established if the lower bound of the 95% CI for the difference of proportions (Probuphine - SL BPN) was greater than -0.20."|Difference in Response Rate|0.088|||<|0.001|TWO_SIDED|95.0|0.009|0.167|||Chi-squared|||||0.167|0.009|<.001
91644581|NCT02180659|183180296|SUPERIORITY|At month 6 comparing those subject with no illicit drug use.||||||0.306|||||||Chi-squared|||||||0.306
91644582|NCT02180659|183180297|SUPERIORITY|||||||0.037|||||||Log Rank|||||||.037
91644583|NCT02180659|183180299|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.832|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.832
91644584|NCT02180659|183180300|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||ANOVA|||||||0.922
91644585|NCT02180659|183180301|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.425|TWO_SIDED||||||ANOVA|||||||0.425
91644586|NCT02180659|183180302|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.505|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.505
91644587|NCT00518011|183180304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.842||||0.3644|TWO_SIDED|95.0|0.483|7.027|||Log Rank|||||7.027|0.483|0.3644
91644588|NCT00518011|183180308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.7165|TWO_SIDED|95.0|0.339|4.824|||Log Rank|||||4.824|0.339|0.7165
91644589|NCT00090259|183180330|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.899||||0.027|TWO_SIDED|95.0|0.818|0.988|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.988|0.818|0.027
91644590|NCT00090259|183180331|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.924||||0.068|TWO_SIDED|95.0|0.848|1.006|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.006|0.848|0.068
91644591|NCT00090259|183180332|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.235|TWO_SIDED|95.0|0.84|1.044|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.044|0.840|0.235
91644592|NCT00090259|183180333|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.865||||0.025|TWO_SIDED|95.0|0.762|0.982|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.982|0.762|0.025
91644593|NCT00090259|183180334|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.892||||0.023|TWO_SIDED|95.0|0.808|0.984|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.984|0.808|0.023
91706966|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.643|||||TWO_SIDED|95.0|2.25|3.04|||||Comparison of GLP-1 active, iAUC 0-2|||3.04|2.25|
91644594|NCT03701516|183180335|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-0.38|STANDARD_DEVIATION|1.781|||TWO_SIDED|98.0|-4.53|3.85|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||3.85|-4.53|
91644595|NCT03701516|183180336|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-2.34|STANDARD_DEVIATION|1.263|||TWO_SIDED|98.0|-5.36|0.61|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.61|-5.36|
91644596|NCT03701516|183180337|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -1.|Posterior Mean Difference|-0.06|STANDARD_DEVIATION|0.083|||TWO_SIDED|95.0|-0.22|0.1|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.10|-0.22|
91644597|NCT03701516|183180338|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|0.001|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|-0.005|0.006|||Bayesian repeated measurement random-eff|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.006|-0.005|
91644598|NCT03701516|183180339|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|-0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|-0.009|0.002|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.002|-0.009|
91644599|NCT00956813|183180382|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
91644600|NCT00956813|183180384|SUPERIORITY_OR_OTHER|||||||0.93|||||||Kruskal-Wallis|||||||0.93
91644601|NCT00956813|183180385|SUPERIORITY_OR_OTHER|||||||0.19|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.||||0.19
91644602|NCT00956813|183180385|SUPERIORITY_OR_OTHER|||||||0.78|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.||||0.78
91644603|NCT00956813|183180385|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.||||0.238
91644604|NCT00956813|183180385|SUPERIORITY_OR_OTHER|||||||0.497|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.||||0.497
91644605|NCT00956813|183180386|SUPERIORITY_OR_OTHER|||||||0.089|||||||Kruskal-Wallis|||||||0.089
91644606|NCT03083639|183180394|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUC∞ using analysis of variance (ANOVA) models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90 percent (%) confidence intervals (CIs) for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|1.018|||||TWO_SIDED|90.0|0.969|1.07||||||||1.070|0.969|
91644607|NCT03083639|183180395|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUCt using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|0.993|||||TWO_SIDED|90.0|0.939|1.05||||||||1.050|0.939|
91644608|NCT03083639|183180396|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of Cmax using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of Cmax central values between esomeprazole capsules and tablets are presented.|Point estimate|0.942|||||TWO_SIDED|90.0|0.88|1.009||||||||1.009|0.880|
91644609|NCT03611751|183180407|SUPERIORITY||Odds Ratio (OR)|10.55|||<|0.0001|TWO_SIDED|95.0|6.54|17.0|||Cochran-Mantel-Haenszel|||||17.00|6.54|<0.0001
91644610|NCT03611751|183180408|SUPERIORITY||Odds Ratio (OR)|10.49|||<|0.0001|TWO_SIDED|95.0|6.65|16.55|||Cochran-Mantel-Haenszel|||||16.55|6.65|<0.0001
91644611|NCT03611751|183180409|SUPERIORITY||Odds Ratio (OR)|11.42|||<|0.0001|TWO_SIDED|95.0|5.45|23.93|||Cochran-Mantel-Haenszel|||||23.93|5.45|<0.0001
91644612|NCT03611751|183180409|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0046|TWO_SIDED|95.0|1.18|2.56|||Cochran-Mantel-Haenszel|||||2.56|1.18|0.0046
91644613|NCT03611751|183180410|SUPERIORITY||Odds Ratio (OR)|9.21|||<|0.001|TWO_SIDED|95.0|2.89|29.4|||Cochran-Mantel-Haenszel|||||29.40|2.89|<0.001
91644614|NCT03611751|183180410|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0051|TWO_SIDED|95.0|1.3|5.0|||Cochran-Mantel-Haenszel|||||5.00|1.30|0.0051
91644615|NCT03611751|183180411|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.0001|TWO_SIDED|95.0|4.62|45.11|||Cochran-Mantel-Haenszel|||||45.11|4.62|<0.0001
91644616|NCT03611751|183180411|SUPERIORITY||Odds Ratio (OR)|2.85||||0.0002|TWO_SIDED|95.0|1.61|5.03|||Cochran-Mantel-Haenszel|||||5.03|1.61|0.0002
91644617|NCT03611751|183180412|SUPERIORITY||Mean Difference (Net)|-23.6|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-26.9|-20.3|||ANCOVA|||||-20.3|-26.9|<0.0001
91644618|NCT03611751|183180412|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|-10.5|-3.9|||ANCOVA|||||-3.9|-10.5|<0.0001
91644619|NCT03611751|183180413|SUPERIORITY||Odds Ratio (OR)|6.4||||0.0005|TWO_SIDED|95.0|1.94|21.15|||Cochran-Mantel-Haenszel|||||21.15|1.94|0.0005
91644620|NCT03611751|183180413|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0928|TWO_SIDED|95.0|0.89|3.71|||Cochran-Mantel-Haenszel|||||3.71|0.89|0.0928
91644621|NCT03611751|183180414|SUPERIORITY||Odds Ratio (OR)|6.85|||<|0.0001|TWO_SIDED|95.0|4.34|10.81|||Cochran-Mantel-Haenszel|||||10.81|4.34|<0.0001
91644622|NCT03611751|183180414|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.77|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.77|<0.0001
91644623|NCT03611751|183180415|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.42|8.47|||Cochran-Mantel-Haenszel|||||8.47|3.42|<0.0001
91644624|NCT03611751|183180416|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0621|TWO_SIDED|95.0|0.88|11.79|||Cochran-Mantel-Haenszel|||||11.79|0.88|0.0621
91644625|NCT03611751|183180417|SUPERIORITY||Odds Ratio (OR)|0.64||||0.6692|TWO_SIDED|95.0|0.06|7.46|||Cochran-Mantel-Haenszel|||||7.46|0.06|0.6692
91644626|NCT03611751|183180417|SUPERIORITY||Odds Ratio (OR)|0.32||||0.3793|TWO_SIDED|95.0|0.02|5.56|||Cochran-Mantel-Haenszel|||||5.56|0.02|0.3793
91644627|NCT03611751|183180418|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0004|TWO_SIDED|95.0|1.29|2.41|||Cochran-Mantel-Haenszel|||||2.41|1.29|0.0004
91644628|NCT03611751|183180419|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.45|2.78|||Cochran-Mantel-Haenszel|||||2.78|1.45|<0.0001
91644629|NCT03611751|183180420|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
91644630|NCT03611751|183180421|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.78|3.43|||Cochran-Mantel-Haenszel|||||3.43|1.78|<0.0001
91644631|NCT03611751|183180422|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.78|3.36|||Cochran-Mantel-Haenszel|||||3.36|1.78|<0.0001
91644632|NCT03611751|183180423|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0001|TWO_SIDED|95.0|1.43|3.01|||Cochran-Mantel-Haenszel|||||3.01|1.43|0.0001
91644633|NCT00903409|183180436|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The difference between Non-switchers and Switchers in the percent change in non-HDL-C level from the end of the OM6 double-blind study (average of Weeks 6 and 8 for the statistical analysis) to 4 months of OM6X open-label treatment (Month 4).|Kruskal-Wallis|||||||<0.001
91644634|NCT03539952|183180455|NON_INFERIORITY|The primary efficacy analysis utilized the serum NCC values from all study visits that were analyzed using a restricted maximum likelihood based general linear model for correlated data. The correlation due to repeated measures was modeled by specifying the variance covariance matrix. Considering a comparison of means in both treatment arms (D-penicillamine minus TETA 4HCl) at the 1-sided 2.5% level of Type 1 error, a non-inferiority margin of 50 μg/L was used.|Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|7.49|||TWO_SIDED|||||||||The primary endpoint was the assessment of the non-inferiority of TETA 4HCl in relation to D-penicillamine. The non-inferiority assessment was made on the basis of the mean serum NCC level at Week 36.||||
91644635|NCT01371006|183180460|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|105.61|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|90.81|122.82|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||122.82|90.81|
91644636|NCT01371006|183180461|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|116.12|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|101.87|132.35|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||132.35|101.87|
91644637|NCT01371006|183180462|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|71.83|STANDARD_DEVIATION|23.6|||TWO_SIDED|90.0|61.46|83.95|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||83.95|61.46|
91644638|NCT01371006|183180463|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|64.97|STANDARD_DEVIATION|30.2|||TWO_SIDED|90.0|53.32|79.16|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||79.16|53.32|
91644639|NCT01371006|183180464|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|54.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|40.47|72.88|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||72.88|40.47|
91644640|NCT03256526|183180477|SUPERIORITY||LS mean difference|11.45||||0.1654|TWO_SIDED|90.0|-2.19|25.09|||ANCOVA|||||25.09|-2.19|0.1654
91644641|NCT03256526|183180477|SUPERIORITY||LS mean difference|-18.73||||0.0395|TWO_SIDED|90.0|-33.55|-3.9|||ANCOVA|||||-3.90|-33.55|0.0395
91644642|NCT01186744|183180485|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Log Rank|||||||0.0008
91644643|NCT01186744|183180485|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91644644|NCT01186744|183180486|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Log Rank|||||||0.0027
91644645|NCT01186744|183180486|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91644646|NCT03515837|183180625|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0122|TWO_SIDED|95.0|0.65|0.97|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||0.97|0.65|0.0122
91644647|NCT03515837|183180626|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0362|TWO_SIDED|95.0|0.69|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.02|0.69|0.0362
91644648|NCT03515837|183180627|SUPERIORITY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-6.0|9.9|||||Based on Miettinen \& Nurminen method stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||9.9|-6.0|
91644649|NCT03515837|183180629|OTHER||Difference in LS Means|1.59|||||TWO_SIDED|95.0|-1.93|5.1|||||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors PD-L1 expression, treatment history, and geographic region of the enrolling site as covariates.|||5.10|-1.93|
91644650|NCT03515837|183180630|OTHER||Hazard Ratio (HR)|0.93||||||95.0|0.68|1.27|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.27|0.68|
91644651|NCT01856686|183180638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56593|||||||ANCOVA|||Between-Group Comparison||||0.56593
91644652|NCT01856686|183180638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44929|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.44929
91644653|NCT01856686|183180638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81844|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.81844
91644654|NCT01856686|183180639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71152|||||||ANCOVA|||Between-Group Comparison||||0.71152
91644655|NCT01856686|183180639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
91644656|NCT01856686|183180639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47616|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.47616
91644657|NCT01856686|183180640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.10036|||||||ANCOVA|||Between-Group Comparison||||0.10036
91644658|NCT01856686|183180640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082|||||||Paired t-test|||Within-group changes||||0.00820
91644659|NCT01856686|183180640|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||1.00000
91644660|NCT01856686|183180641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92193|||||||ANCOVA|||Between-Group Comparison||||0.92193
91644661|NCT01856686|183180641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50704|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.50704
91644662|NCT01856686|183180641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42314|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.42314
91644663|NCT01856686|183180642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08946|||||||ANCOVA|||Between-Group Comparison||||0.08946
91644664|NCT01856686|183180642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
91644665|NCT01856686|183180642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.01090
91644666|NCT01856686|183180643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73209|||||||ANCOVA|||Between-Group Comparison||||0.73209
91644667|NCT01856686|183180643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07965|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07965
91644668|NCT01856686|183180643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61613|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.61613
91644669|NCT01856686|183180644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33027|||||||ANCOVA|||Between-Group Comparison||||0.33027
91644670|NCT01856686|183180644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00013|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00013
91644671|NCT01856686|183180644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28019|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.28019
91644672|NCT01856686|183180645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94449|||||||ANCOVA|||Between-Group Comparison||||0.94449
91644673|NCT01856686|183180645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
91644674|NCT01856686|183180645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85428|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.85428
91644675|NCT01856686|183180646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83929|||||||ANCOVA|||Between-Group Comparison||||0.83929
91644676|NCT01856686|183180646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97213|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.97213
91644677|NCT01856686|183180646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58323|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.58323
91644678|NCT01856686|183180647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05158|||||||ANCOVA|||Between-Group Comparison||||0.05158
91644679|NCT01856686|183180647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
91644680|NCT01856686|183180647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09331|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.09331
91644681|NCT01856686|183180648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17383|||||||ANCOVA|||Between-Group Comparison||||0.17383
91644682|NCT01856686|183180648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00092|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00092
91644683|NCT01856686|183180648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15544|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.15544
91644684|NCT01856686|183180649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39707|||||||ANCOVA|||Between-Group Comparison||||0.39707
91644685|NCT01856686|183180649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27945|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27945
91644686|NCT01856686|183180649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.19739
91644687|NCT01856686|183180650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50964|||||||ANCOVA|||Between-Group Comparison||||0.50964
91644688|NCT01856686|183180650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0071|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00710
91644689|NCT01856686|183180650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00595|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00595
91644690|NCT01856686|183180651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48336|||||||ANCOVA|||Between-Group Comparison||||0.48336
91644691|NCT01856686|183180651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08739
91644692|NCT01856686|183180651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37046|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.37046
91644693|NCT01856686|183180653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45013|||||||ANCOVA|||Between-Group Comparison||||0.45013
91644694|NCT01856686|183180653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17374|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.17374
91644695|NCT01856686|183180653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07548|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07548
91644696|NCT01856686|183180654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23226|||||||ANCOVA|||Between-Group Comparison||||0.23226
91644697|NCT01856686|183180654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08812|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08812
91644698|NCT01856686|183180654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00776|||||||Pairedt-test|||Within-group comparisons between the baseline and 3 month data||||0.00776
91644699|NCT01856686|183180655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.90843|||||||ANCOVA|||Between-Group Comparison||||0.90843
91644700|NCT01856686|183180655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00413|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00413
91644701|NCT01856686|183180655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00775|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00775
91644702|NCT02367729|183180668|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.3947||0.003|TWO_SIDED|95.0|1.37|2.93|||Wilcoxon (Mann-Whitney)|||||2.93|1.37|0.003
91644703|NCT00759174|183180674|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.033|TWO_SIDED|95.0|1.06|4.34|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.34|1.06|0.033
91644704|NCT00759174|183180675|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.003|TWO_SIDED|95.0|1.33|4.19|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.19|1.33|0.003
91644705|NCT00759174|183180676|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|1.7|7.69|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||7.69|1.70|<0.001
91644706|NCT01890109|183180677|SUPERIORITY||Least Square Geometric Mean Ratio|1.1||||0.723|TWO_SIDED|95.0|0.66|1.83|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the number of daily moderate to severe hot flashes. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline number of daily moderate to severe hot flashes was used as a covariate.||1.83|0.66|0.723
91644707|NCT01890109|183180678|SUPERIORITY||Least Square Geometric Mean Ratio|1.14||||0.551|TWO_SIDED|95.0|0.74|1.74|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the daily hot flash severity score. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline daily hot flash severity score was used as a covariate.||1.74|0.74|0.551
91644708|NCT03359473|183180810|OTHER||Mean Difference (Net)|4.53|||||TWO_SIDED|90.0|-1.3|10.36|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||10.36|-1.30|
91644709|NCT03359473|183180810|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|90.0|0.83|14.76|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.76|0.83|
91644710|NCT03359473|183180811|OTHER||Mean Difference (Net)|16.71|||||TWO_SIDED|90.0|9.86|23.56|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||23.56|9.86|
91644711|NCT03359473|183180811|OTHER||Mean Difference (Net)|5.35|||||TWO_SIDED|90.0|-4.09|14.78|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.78|-4.09|
91644712|NCT03359473|183180812|OTHER||Mean Difference (Net)|5.17|||||TWO_SIDED|90.0|-4.67|15.01|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||15.01|-4.67|
91644713|NCT03359473|183180812|OTHER||Mean Difference (Net)|7.02|||||TWO_SIDED|90.0|0.46|13.58|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.58|0.46|
91644714|NCT03359473|183180813|OTHER||Mean Difference (Net)|5.9|||||TWO_SIDED|90.0|-1.4|13.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.2|-1.4|
91644715|NCT03359473|183180813|OTHER||Mean Difference (Net)|13.5|||||TWO_SIDED|90.0|1.6|25.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.5|1.6|
91644716|NCT03359473|183180814|OTHER||Mean Difference (Net)|20.7|||||TWO_SIDED|90.0|10.1|31.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||31.2|10.1|
91644717|NCT03359473|183180814|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|90.0|-11.1|25.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.8|-11.1|
91644718|NCT03359473|183180815|OTHER||Mean Difference (Net)|8.0|||||TWO_SIDED|90.0|-2.5|18.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||18.4|-2.5|
91644719|NCT03359473|183180815|OTHER||Mean Difference (Net)|11.8|||||TWO_SIDED|90.0|-0.5|24.0|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||24.0|-0.5|
91644720|NCT03359473|183180816|OTHER||Mean Difference (Net)|0.882|||||TWO_SIDED|90.0|0.643|1.121|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.121|0.643|
91706967|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-1.44|1.55|||||Comparison of GLP-1 total, AUC 0-2|||1.55|-1.44|
91644721|NCT03359473|183180816|OTHER||Mean Difference (Net)|0.291|||||TWO_SIDED|90.0|-0.156|0.738|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||0.738|-0.156|
91644722|NCT03359473|183180817|OTHER||Mean Difference (Net)|0.982|||||TWO_SIDED|90.0|0.629|1.334|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.334|0.629|
91706968|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|||||TWO_SIDED|95.0|-1.28|1.82|||||Comparison of GLP-1 total, AUC 0-2|||1.82|-1.28|
91644723|NCT03359473|183180817|OTHER||Mean Difference (Net)|1.127|||||TWO_SIDED|90.0|0.682|1.571|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.571|0.682|
91644724|NCT03359473|183180818|OTHER||Mean Difference (Net)|1.38|||||TWO_SIDED|90.0|0.964|1.795|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.795|0.964|
91644725|NCT03359473|183180818|OTHER||Mean Difference (Net)|1.124|||||TWO_SIDED|90.0|0.594|1.654|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.654|0.594|
91644726|NCT03359473|183180819|OTHER||Mean Difference (Net)|1.167|||||TWO_SIDED|90.0|0.677|1.658|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.658|0.677|
91644727|NCT03359473|183180819|OTHER||Mean Difference (Net)|0.923|||||TWO_SIDED|90.0|0.222|1.623|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.623|0.222|
91644728|NCT03359473|183180820|OTHER||Mean Difference (Net)|2.085|||||TWO_SIDED|90.0|1.493|2.678|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.678|1.493|
91644729|NCT03359473|183180820|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|90.0|0.801|2.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.600|0.801|
91644730|NCT03359473|183180821|OTHER||Mean Difference (Net)|2.108|||||TWO_SIDED|90.0|1.271|2.945|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.945|1.271|
91644731|NCT03359473|183180821|OTHER||Mean Difference (Net)|2.113|||||TWO_SIDED|90.0|0.949|3.277|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||3.277|0.949|
91644732|NCT03359473|183180822|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
91644733|NCT03359473|183180822|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.4|0.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.5|-0.4|
91644734|NCT03359473|183180823|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
91644735|NCT03359473|183180823|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|90.0|-0.2|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.2|
91644736|NCT03359473|183180824|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|90.0|-0.4|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.4|
91644737|NCT03359473|183180824|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|90.0|-0.5|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.5|
91644738|NCT03359473|183180825|OTHER||Mean Difference (Net)|-0.553|||||TWO_SIDED|90.0|-2.082|0.977|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.977|-2.082|
91519713|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.31|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.31
91644739|NCT03359473|183180825|OTHER||Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.977|0.832|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.832|-0.977|
91644740|NCT03359473|183180826|OTHER||Mean Difference (Net)|-0.816|||||TWO_SIDED|90.0|-2.252|0.619|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.619|-2.252|
91644741|NCT03359473|183180826|OTHER||Mean Difference (Net)|0.163|||||TWO_SIDED|90.0|-1.096|1.422|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.422|-1.096|
91644742|NCT03359473|183180827|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|90.0|-2.668|0.748|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.748|-2.668|
91644743|NCT03359473|183180827|OTHER||Mean Difference (Net)|-1.937|||||TWO_SIDED|90.0|-5.208|1.333|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.333|-5.208|
91644744|NCT03359473|183180828|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|90.0|-0.314|0.233|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.233|-0.314|
91644745|NCT03359473|183180828|OTHER||Mean Difference (Net)|0.058|||||TWO_SIDED|90.0|-0.209|0.324|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.324|-0.209|
91644746|NCT03359473|183180829|OTHER||Mean Difference (Net)|-0.287|||||TWO_SIDED|90.0|-0.65|0.077|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.077|-0.650|
91706969|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.894|||||TWO_SIDED|95.0|-0.65|2.44|||||Comparison of GLP-1 total, AUC 0-2|||2.44|-0.65|
91644747|NCT03359473|183180829|OTHER||Mean Difference (Net)|-0.191|||||TWO_SIDED|90.0|-0.534|0.152|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.152|-0.534|
91644748|NCT03359473|183180830|OTHER||Mean Difference (Net)|-0.012|||||TWO_SIDED|90.0|-0.555|0.532|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.532|-0.555|
91644749|NCT03359473|183180830|OTHER||Mean Difference (Net)|-0.231|||||TWO_SIDED|90.0|-0.541|0.08|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.080|-0.541|
91644750|NCT03359473|183180831|OTHER||Difference in Least Square Means|11.1|||||TWO_SIDED|90.0|-57.1|79.2|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||79.2|-57.1|
91644751|NCT03359473|183180831|OTHER||Difference in Least Square Means|-149.3|||||TWO_SIDED|90.0|-280.6|-18.1|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||-18.1|-280.6|
91644752|NCT03359473|183180832|OTHER||Difference in Least Square Means|-6.7|||||TWO_SIDED|90.0|-42.7|29.2|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||29.2|-42.7|
91644753|NCT03359473|183180832|OTHER||Difference in Least Square Means|-34.8|||||TWO_SIDED|90.0|-72.0|2.4|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||2.4|-72.0|
91644754|NCT03359473|183180833|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|90.0|-2.6|1.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.9|-2.6|
91644755|NCT03359473|183180833|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-3.4|2.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||2.1|-3.4|
91644756|NCT03359473|183180834|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|90.0|-2.9|1.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.1|-2.9|
91644757|NCT03359473|183180834|OTHER||Mean Difference (Net)|2.2|||||TWO_SIDED|90.0|0.0|4.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||4.5|0.0|
91644758|NCT03359473|183180835|OTHER||Mean Difference (Net)|-4.7|||||TWO_SIDED|90.0|-8.9|-0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.6|-8.9|
91644759|NCT03359473|183180835|OTHER||Mean Difference (Net)|-2.1|||||TWO_SIDED|90.0|-7.2|3.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||3.1|-7.2|
91644760|NCT03359473|183180836|OTHER||Mean Difference (Net)|-4.9|||||TWO_SIDED|90.0|-9.5|-0.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.4|-9.5|
91644761|NCT03359473|183180836|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|90.0|-10.3|2.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||2.2|-10.3|
91644762|NCT03359473|183180837|OTHER||Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-5.9|-0.3|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||-0.3|-5.9|
91644763|NCT03359473|183180837|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|90.0|-4.6|4.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||4.2|-4.6|
91644764|NCT03359473|183180838|OTHER||Mean Difference (Net)|4.0|||||TWO_SIDED|90.0|-0.8|8.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||8.8|-0.8|
91644765|NCT03359473|183180838|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|90.0|-2.3|9.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||9.4|-2.3|
91644766|NCT03359473|183180839|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|90.0|-6.5|-1.9|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||-1.9|-6.5|
91644767|NCT03359473|183180839|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|90.0|-4.1|1.1|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.1|-4.1|
91644768|NCT03359473|183180840|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-3.8|1.8|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.8|-3.8|
91706970|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.483|||||TWO_SIDED|95.0|-2.85|-0.12|||||Comparison of GLP-1 total, AUC 0-2|||-0.12|-2.85|
91706971|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|||||TWO_SIDED|95.0|-1.18|1.34|||||Comparison of GLP-1 total, iAUC 0-2|||1.34|-1.18|
91581630|NCT02349425|183053229|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0447|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-1.7|0.0447
91644769|NCT03359473|183180840|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-4.6|3.2|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||3.2|-4.6|
91644770|NCT03359473|183180845|OTHER||Difference in Least Square Means|3.0|||||TWO_SIDED|90.0|-1.4|7.4|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||7.4|-1.4|
91644771|NCT03359473|183180845|OTHER||Difference in Least Square Means|2.1|||||TWO_SIDED|90.0|-2.3|6.5|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||6.5|-2.3|
91644772|NCT03359473|183180846|OTHER||Difference in Least Square Means|2.6|||||TWO_SIDED|90.0|-5.0|10.1|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||10.1|-5.0|
91644773|NCT03359473|183180846|OTHER||Difference in Least Square Means|-0.5|||||TWO_SIDED|90.0|-8.4|7.5|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||7.5|-8.4|
91644774|NCT03359473|183180847|OTHER||Difference in Least Square Means|2.0|||||TWO_SIDED|90.0|-3.2|7.1|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||7.1|-3.2|
91644775|NCT03359473|183180847|OTHER||Difference in Least Square Means|0.5|||||TWO_SIDED|90.0|-5.6|6.5|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||6.5|-5.6|
91644776|NCT03359473|183180848|OTHER||Difference in Least Square Means|3.4|||||TWO_SIDED|90.0|-1.7|8.6|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||8.6|-1.7|
91644777|NCT03359473|183180848|OTHER||Difference in Least Square Means|3.5|||||TWO_SIDED|90.0|-0.7|7.7|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||7.7|-0.7|
91644778|NCT04101721|183180860|NON_INFERIORITY|Non-inferiority margin is 5%|Adjusted difference|1.81|||||TWO_SIDED|95.1|-15.71|19.33||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||19.33|-15.71|
91644779|NCT04101721|183180861|SUPERIORITY||Adjusted difference|-3.66|||||TWO_SIDED|95.1|-19.86|12.54||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||12.54|-19.86|
91644780|NCT04101721|183180862|SUPERIORITY||Adjusted difference|10.1|||||TWO_SIDED|95.1|-9.83|30.02||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status||30.02|-9.83|
91644781|NCT01215955|183180865|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|||||TWO_SIDED|95.0|-0.15|0.22|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.22|-0.15|
91644782|NCT01215955|183180865|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|||||TWO_SIDED|95.0|-0.12|0.24|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.24|-0.12|
91644783|NCT01215955|183180866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.128|TWO_SIDED|95.0|0.52|1.09||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.09|0.520|0.128
91644784|NCT01215955|183180866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.625|TWO_SIDED|95.0|0.58|1.39||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.39|0.580|0.625
91644785|NCT01215955|183180866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.162|TWO_SIDED|95.0|0.53|1.11||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.11|0.53|0.162
91644786|NCT01215955|183180866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.723|TWO_SIDED|95.0|0.61|1.4||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Linear|||||1.40|0.61|0.723
91644787|NCT01215955|183180867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.701|TWO_SIDED|95.0|0.52|2.67||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||2.67|0.520|0.701
91644788|NCT01215955|183180867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.249|TWO_SIDED|95.0|0.71|3.7||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||3.70|0.710|0.249
91644789|NCT01215955|183180867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.8||P-value is for HbA1c ≤7% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|Included treatment and effects for baseline stratification variables: Baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use.||||0.80|0.13|0.015
91644790|NCT01215955|183180867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.078|TWO_SIDED|95.0|0.17|1.1||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.10|0.17|0.078
91644791|NCT01215955|183180868|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81||||0.014|TWO_SIDED|95.0|0.17|1.46||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||1.46|0.17|0.014
91644792|NCT01215955|183180868|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.5||||0.108|TWO_SIDED|95.0|-1.12|0.11||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.11|-1.12|0.108
91644793|NCT01215955|183180869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.182|TWO_SIDED|95.0|0.57|1.11||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.11|0.57|0.182
91644794|NCT01215955|183180869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.22|0.65|0.460
91644795|NCT01215955|183180870|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|||||TWO_SIDED|95.0|-0.19|0.77|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||0.77|-0.19|
91644796|NCT01215955|183180870|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|||||TWO_SIDED|95.0|0.3|1.31|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||1.31|0.30|
91644797|NCT01215955|183180871|SUPERIORITY_OR_OTHER||LS Mean Differences|0.59||||0.242|TWO_SIDED|95.0|-0.4|1.58||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||1.58|-0.40|0.242
91644798|NCT01215955|183180871|SUPERIORITY_OR_OTHER||LS Mean Differences|1.13||||0.082|TWO_SIDED|95.0|-0.15|2.41||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without 24-week values were handled by the statistical model.|||2.41|-0.15|0.082
91644799|NCT01215955|183180872|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.15||||0.723|TWO_SIDED|95.0|-0.95|0.66||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.66|-0.95|0.723
91644800|NCT01215955|183180872|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.28||||0.495|TWO_SIDED|95.0|-1.08|0.52||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.52|-1.08|0.495
91644801|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|3.32||||0.245|TWO_SIDED|95.0|-2.28|8.93||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||8.93|-2.28|0.245
91644802|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71||||0.842|TWO_SIDED|95.0|-7.71|6.29||P-value is for Morning 2-HR PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.29|-7.71|0.842
91706972|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|-0.97|1.63|||||Comparison of GLP-1 total, iAUC 0-2|||1.63|-0.97|
91644803|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42||||0.626||95.0|-4.32|7.16||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.16|-4.32|0.626
91644804|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.48||||0.358|TWO_SIDED|95.0|-10.91|3.95||P-value is for Midday 2-Hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||3.95|-10.91|0.358
91644805|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|3.38||||0.322|TWO_SIDED|95.0|-3.32|10.07||P-value is for Evening Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.07|-3.32|0.322
91644806|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25||||0.617|TWO_SIDED|95.0|-11.08|6.58||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.58|-11.08|0.617
91644807|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37||||0.519|TWO_SIDED|95.0|-4.86|9.6||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||9.60|-4.86|0.519
91644808|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.415|TWO_SIDED|95.0|-2.96|7.15||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.15|-2.96|0.415
91644809|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|4.38||||0.198|TWO_SIDED|95.0|-2.3|11.06||P-value is for Morning 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||11.06|-2.30|0.198
91644810|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|6.22||||0.045|TWO_SIDED|95.0|0.14|12.29||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.29|0.14|0.045
91644811|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|3.07||||0.426|TWO_SIDED|95.0|-4.5|10.64||P-value is for Midday 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.64|-4.50|0.426
91644812|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.14|TWO_SIDED|95.0|-1.86|13.17||P-value is for Evening Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||13.17|-1.86|0.140
91706973|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.177|||||TWO_SIDED|95.0|-1.48|1.12|||||Comparison of GLP-1 total, iAUC 0-2|||1.12|-1.48|
91706974|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.19|||||TWO_SIDED|95.0|-2.34|-0.04|||||Comparison of GLP-1 total, iAUC 0-2|||-0.04|-2.34|
91644813|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|11.18||||0.02|TWO_SIDED|95.0|1.74|20.63||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||20.63|1.74|0.020
91644814|NCT01215955|183180873|SUPERIORITY_OR_OTHER||LS Mean Difference|9.01||||0.037|TWO_SIDED|95.0|0.53|17.49||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||17.49|0.53|0.037
91644815|NCT01215955|183180874|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.543|TWO_SIDED|95.0|-2.55|4.84||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.84|-2.55|0.543
91644816|NCT01215955|183180874|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.095|TWO_SIDED|95.0|-1.17|14.6||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||14.60|-1.17|0.095
91644817|NCT01215955|183180874|SUPERIORITY_OR_OTHER||LS Mean Difference|8.86||||0.059|TWO_SIDED|95.0|-0.35|18.06||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||18.06|-0.35|0.059
91644818|NCT01215955|183180874|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.497|TWO_SIDED|95.0|-2.05|4.23||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.23|-2.05|0.497
91644819|NCT01215955|183180874|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37||||0.156|TWO_SIDED|95.0|-2.06|12.79||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.79|-2.06|0.156
91644820|NCT01215955|183180874|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05||||0.222|TWO_SIDED|95.0|-3.67|15.76||P-value of for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||15.76|-3.67|0.222
91644821|NCT01215955|183180875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.442|TWO_SIDED|95.0|-0.02|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.02|0.442
91644822|NCT01215955|183180875|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.037|TWO_SIDED|95.0|0.0|0.14||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.14|0.00|0.037
91706975|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.235|||||TWO_SIDED|95.0|-1.51|3.98|||||Comparison of Glucagon, AUC 0-2|||3.98|-1.51|
91644823|NCT01215955|183180875|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.16||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.16|0.05|<0.001
91644824|NCT01215955|183180875|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.275|TWO_SIDED|95.0|-0.01|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.01|0.275
91644825|NCT01215955|183180875|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.194|TWO_SIDED|95.0|-0.02|0.08||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.08|-0.02|0.194
91644826|NCT01215955|183180875|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.245|TWO_SIDED|95.0|-0.04|0.15||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.15|-0.04|0.245
91644827|NCT01215955|183180876|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.435
91644828|NCT01215955|183180876|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.351
91644829|NCT01215955|183180877|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.802
91644830|NCT01215955|183180877|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.205
91644831|NCT01215955|183180878|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio of Negative Binomial|1.06||||0.586|TWO_SIDED|95.0|0.86|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial Regression|||||1.30|0.86|0.586
91644832|NCT01215955|183180878|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio Negative Binomial|1.05||||0.689|TWO_SIDED|95.0|0.84|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial|||||1.30|0.84|0.689
91644833|NCT01215955|183180879|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.258
91644834|NCT01215955|183180879|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.856
91644835|NCT02643394|183180909|SUPERIORITY|||||||0.252|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.252
91644836|NCT02643394|183180910|SUPERIORITY|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||||||0.402
91644837|NCT04193033|183180925|SUPERIORITY|||||||0.001|||||||Linear Growth Curve Model|||||||0.001
91644838|NCT04193033|183180926|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
91644839|NCT04193033|183180927|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
91644840|NCT04193033|183180929|SUPERIORITY|||||||0.49|||||||Linear Growth Curve Model|Time was included as a fixed effect and both time and intercept were included as random effects.||||||.49
91706976|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.877|||||TWO_SIDED|95.0|0.04|5.71|||||Comparison of Glucagon, AUC 0-2|||5.71|0.04|
91706977|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.473|||||TWO_SIDED|95.0|-1.21|4.16|||||Comparison of Glucagon, AUC 0-2|||4.16|-1.21|
91644841|NCT04193033|183180931|SUPERIORITY|||||||0.06||||||Paired t-test, alpha = .05.|t-test, 2 sided|||||||0.06
91644842|NCT01154673|183180942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.056|TWO_SIDED|95.0|-0.006|0.4||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|Regression, Linear||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|||0.4|-.006|0.056
91644843|NCT03728257|183180955|SUPERIORITY|Change in average steps per day between baseline and 3 months was compared between the two groups.||||||0.8793||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.8793
91644844|NCT03728257|183180956|SUPERIORITY|Change in average steps per day between baseline and 6 months was compared between the two groups.||||||0.9597||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.9597
91644845|NCT03728257|183180957|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.3||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
91644846|NCT03728257|183180958|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.81||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.81
91644847|NCT03728257|183180959|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 3 months was compared between the two groups.||||||0.2262||||||a priori threshold for statistical significance is p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.2262
91644848|NCT03728257|183180960|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 6 months was compared between the two groups.||||||0.59||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.59
91644849|NCT03728257|183180961|SUPERIORITY|Change in SGRQ between baseline and 3 months was compared between the two groups.||||||0.26||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.26
91706978|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|||||TWO_SIDED|95.0|-2.2|2.74|||||Comparison of Glucagon, AUC 0-2|||2.74|-2.20|
91706979|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.177|||||TWO_SIDED|95.0|-4.92|0.56|||||Comparison of Glucagon, iAUC 0-2|||0.56|-4.92|
91706980|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.909|||||TWO_SIDED|95.0|-4.74|0.93|||||Comparison of Glucagon, iAUC 0-2|||0.93|-4.74|
91706981|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|||||TWO_SIDED|95.0|-3.74|1.63|||||Comparison of Glucagon, iAUC 0-2|||1.63|-3.74|
91706982|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.249|||||TWO_SIDED|95.0|-3.72|1.22|||||Comparison of Glucagon, iAUC 0-2|||1.22|-3.72|
91519714|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.29|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.29
91644850|NCT03728257|183180962|SUPERIORITY|Change in SGRQ between baseline and 6 months was compared between the two groups.||||||0.78||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
91644851|NCT03728257|183180963|SUPERIORITY|Change in MVPA between baseline and 3 months was compared between the two groups.||||||0.7073||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.7073
91644852|NCT03728257|183180964|SUPERIORITY|Change in MVPA between baseline and 6 months was compared between the two groups.||||||0.313||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.313
91644853|NCT03728257|183180965|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.91||||||a priori threshold for statistical significance p \< 0.05|Chi-squared|||||||0.91
91644854|NCT03728257|183180966|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.72||||||a priori threshold of statistical significance p \< 0.05|Chi-squared|||||||0.72
91644855|NCT01516684|183180976|OTHER|||||||0.036|||||||T-test and chi-square|||Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.||||0.036
91644856|NCT01516684|183180978|OTHER|Marginal mixed model (GEE type)||||||0.094|||||||Mixed Models Analysis|||||||0.094
91644857|NCT01516684|183180979|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
91644858|NCT01516684|183180980|OTHER|Marginal mixed model (GEE type)||||||0.426|||||||Mixed Models Analysis|||||||0.426
91644859|NCT01977482|183181060|SUPERIORITY_OR_OTHER||E0 (g/dL)|-0.664|||||TWO_SIDED|95.0|-0.96|-0.387|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.387|-0.960|
91644860|NCT01977482|183181060|SUPERIORITY_OR_OTHER||ED50 (milligrams[mg])|33.531|||||TWO_SIDED|95.0|15.566|48.948|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||48.948|15.566|
91644861|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.234||||||95.0|2.691|7.94|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||7.940|2.691|
91644862|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Gamma|1.145|||||TWO_SIDED|95.0|0.748|1.738|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.738|0.748|
91644863|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Var|1.012|||||TWO_SIDED|95.0|0.84|1.234|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.234|0.840|
91644864|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Alpha|-0.206|||||TWO_SIDED|95.0|-0.397|-0.014|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.014|-0.397|
91644865|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Minimally Effective Dose (MED) (mg)|0.418|||||TWO_SIDED|95.0|0.0|2.342|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||2.342|0.000|
91644866|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Dose that achieves a change of -0.25g/dL|2.423|||||TWO_SIDED|95.0|0.0|4.15|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||4.150|0.000|
91644867|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Target Dose (TD) (mg)|4.406|||||TWO_SIDED|95.0|2.544|5.995|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.995|2.544|
91644868|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.25 g/dL|6.43|||||TWO_SIDED|95.0|4.698|8.01|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.010|4.698|
91644869|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.5 g/dL|8.542|||||TWO_SIDED|95.0|6.931|10.523|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||10.523|6.931|
91644870|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.75 g/dL|10.8|||||TWO_SIDED|95.0|9.024|14.004|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||14.004|9.024|
91644871|NCT01977482|183181060|SUPERIORITY_OR_OTHER||Dose that achieves a change of 1 g/dL|13.248|||||TWO_SIDED|95.0|10.891|18.916|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||18.916|10.891|
91644872|NCT02547779|183181086|SUPERIORITY||Odds Ratio (OR)|0.95|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
91644873|NCT02547779|183181087|SUPERIORITY||Odds Ratio (OR)|0.98|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
91644874|NCT02957682|183181111|NON_INFERIORITY|Upper confidence interval (CI) limit was compared to the noninferiority margin, which was 0.2%, and noninferiority was declared if the upper CI limit was below the noninferiority margin.|Least Square (LS) Mean Difference|-0.02||||0.6055|TWO_SIDED|95.0|-0.094|0.055||P-value was taken from mixed-effect model with repeated measures (MMRM) analysis.|Mixed-effect Model Repeated Measures||Model: fixed categorical effects of treatment group, randomization strata as per IVRS, time point, treatment-by-time point, strata-by-time point, continuous fixed covariates of baseline SWMS raw score value, baseline value by time-point interaction.|Change at Week 96||0.055|-0.094|0.6055
91644875|NCT02953262|183181124|SUPERIORITY|||||||0.057||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.057
91644876|NCT02953262|183181124|SUPERIORITY|||||||0.753||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.753
91644877|NCT02953262|183181124|SUPERIORITY|||||||0.613||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.613
91644878|NCT02953262|183181125|SUPERIORITY|||||||0.308||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.308
91644879|NCT02953262|183181125|SUPERIORITY|||||||0.154||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.154
91706983|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.389|||||TWO_SIDED|95.0|-95.82|122.59|||||Comparison of Insulin, AUC 0-3|||122.59|-95.82|
91519715|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.23|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.23
91644880|NCT02953262|183181125|SUPERIORITY|||||||0.025||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.025
91644881|NCT02953262|183181126|SUPERIORITY|||||||0.102||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.102
91644882|NCT02953262|183181126|SUPERIORITY|||||||0.023||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.023
91644883|NCT02953262|183181126|SUPERIORITY|||||||0.439||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.439
91644884|NCT02953262|183181127|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.982
91644885|NCT02953262|183181127|SUPERIORITY|||||||0.559||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.559
91644886|NCT02953262|183181127|SUPERIORITY|||||||0.032||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.032
91644887|NCT00203892|183181141|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.028
91644888|NCT00203892|183181142|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
91644889|NCT02964910|183181148|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95% CI of the seroconversion rate difference was not less than -10%.|the seroconversion rate difference(%)|-2.08|||||TWO_SIDED|95.0|-5.23|0.22||||||||0.22|-5.23|
91644890|NCT02964910|183181149|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95%CI of the GMC ratio was not lower than 0.5.|GMC ratio|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
91644891|NCT02964910|183181153|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.778|||||||Chi-squared|||||||0.778
91644892|NCT02964910|183181154|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.728|||||||Chi-squared|||||||0.728
91644893|NCT02964910|183181155|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.949|||||||Chi-squared|||||||0.949
91644894|NCT02964910|183181156|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.614|||||||Chi-squared|||||||0.614
91644895|NCT02964910|183181157|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.956|||||||Chi-squared|||||||0.956
91644896|NCT03829462|183181158|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5334|TWO_SIDED|95.0|0.7|1.98||The threshold for statistical significance was p=0.05|Log Rank|||To show an increase of median overall survival from 7 to 15 months (30% to 57% rates, respectively), with a HR=0.47 and a power of 80% and alpha=5%, 55 events are required for the 78 patients to be randomized considering 15% additional patients for lost to follow-up.||1.98|0.7|0.5334
91644897|NCT03829462|183181158|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8894|TWO_SIDED|95.0|0.59|1.82|||Chi-squared|||||1.82|0.59|0.8894
91644898|NCT03829462|183181159|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1104|TWO_SIDED|95.0|0.4|1.11|||Log Rank|The threshold for statistical significance was p=0.05||||1.11|0.4|0.1104
91644899|NCT03829462|183181159|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1165|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.4|0.1165
91644900|NCT03829462|183181160|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2425|TWO_SIDED|95.0|0.26|1.42||The threshold for statistical significance was p=0.05|Log Rank|||||1.42|0.26|0.2425
91644901|NCT03829462|183181160|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2519|TWO_SIDED|95.0|0.26|1.42|||Chi-squared|||||1.42|0.26|0.2519
91644902|NCT03829462|183181161|SUPERIORITY||Percent difference|46.5||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
91644903|NCT03829462|183181162|SUPERIORITY||Percent difference|7.4||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
91644904|NCT03000075|183181184|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|73.6|||<|0.001|TWO_SIDED|95.0|62.2|85.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||85.0|62.2|< 0.001
91644905|NCT03000075|183181184|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|72.4|||<|0.001|TWO_SIDED|95.0|60.6|84.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.1|60.6|< 0.001
91644906|NCT03000075|183181186|OTHER||Adjusted percentage difference|75.0|||<|0.001|TWO_SIDED|95.0|63.8|86.2||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||86.2|63.8|< 0.001
91644907|NCT03000075|183181186|OTHER||Adjusted percentage difference|82.4|||<|0.001|TWO_SIDED|95.0|72.2|92.6||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||92.6|72.2|< 0.001
91644908|NCT03000075|183181188|OTHER||Adjusted percentage difference|80.3|||<|0.001|TWO_SIDED|95.0|70.1|90.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.4|70.1|< 0.001
91644909|NCT03000075|183181188|OTHER||Adjusted percentage difference|86.0|||<|0.001|TWO_SIDED|95.0|76.8|95.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||95.1|76.8|< 0.001
91644910|NCT03000075|183181190|OTHER||Adjusted percentage difference|22.6|||<|0.001|TWO_SIDED|95.0|11.8|33.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||33.4|11.8|< 0.001
91644911|NCT03000075|183181190|OTHER||Adjusted percentage difference|32.5|||<|0.001|TWO_SIDED|95.0|20.0|45.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||45.0|20.0|< 0.001
91644912|NCT03000075|183181192|OTHER||Adjusted percentage difference|39.2||||0.131|TWO_SIDED|95.0|-11.6|90.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.1|-11.6|0.131
91706984|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||||TWO_SIDED|95.0|-103.25|123.21|||||Comparison of Insulin, AUC 0-3|||123.21|-103.25|
91706985|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.426|||||TWO_SIDED|95.0|-80.43|145.28|||||Comparison of Insulin, AUC 0-3|||145.28|-80.43|
91706986|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.994|||||TWO_SIDED|95.0|-76.77|122.76|||||Comparison of Insulin, AUC 0-3|||122.76|-76.77|
91644913|NCT03000075|183181192|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|31.3||||0.269|TWO_SIDED|95.0|-24.2|86.7||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.7|-24.2|0.269
91644914|NCT00111007|183181194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.492|TWO_SIDED|95.0|0.627|1.31|||log rank test|||||1.310|0.627|0.492
91644915|NCT00111007|183181195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.979|TWO_SIDED|95.0|0.744|1.333|||log rank test|||||1.333|0.744|0.979
91644916|NCT00111007|183181196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.331|TWO_SIDED|95.0|0.641|1.162|||log rank test|||||1.162|0.641|0.331
91644917|NCT00111007|183181197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.398||||0.146|TWO_SIDED|95.0|0.11|1.437|||log rank test|||||1.437|0.110|0.146
91644918|NCT00111007|183181198|SUPERIORITY_OR_OTHER|||||||0.389||95.0|||||Fisher Exact|||||||0.389
91644919|NCT03332212|183181207|OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.164||0.1418|TWO_SIDED|95.0|-0.582|0.087|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.087|-0.582|0.1418
91644920|NCT03332212|183181207|OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.213||0.465|TWO_SIDED|95.0|-0.604|0.286|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.286|-0.604|0.4650
91644921|NCT00929864|183181237|NON_INFERIORITY_OR_EQUIVALENCE|Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).|Difference from adalimumab at Day 365|1.8|||||TWO_SIDED|95.0|-5.6|9.2|||minimum risk weights method|adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||The null and alternative hypotheses are H0: T - C\<= δ vs. Ha:T - C \> δ, where T is the treatment effect of abatacept, C is the effect of active control (adalimumab),and δ is non-inferiority margin. Abatacept is defined as δ non-inferior to adalimumab when H0 is rejected. More specifically, if the lower bound of the 95% two-sided confidence interval for C-T is greater than δ,, then that Abatacept is δ non-inferior to adalimumab can be claimed.||9.2|-5.6|
91644922|NCT00929864|183181238|SUPERIORITY_OR_OTHER||Difference in proportions|-5.37||||0.006|TWO_SIDED|95.0|-9.13|-1.62|||Chi-squared|||Analysis is p-value of difference in proportions. n=number of participants with event, N=number of participants at risk. Proportion = n/N. In order to maintain the overall type I error rate of 0.05 for testing both the primary non-inferiority hypothesis and the key secondary local injection site reaction (LISR) hypothesis, the LISR hypothesis was tested at the 5% significance level only after the primary non-inferiority hypothesis is established at the 5% level.||-1.62|-9.13|0.006
91771786|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.26||||0.4942|TWO_SIDED|95.0|0.22|23.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||23.53|0.22|0.4942
91644923|NCT00929864|183181239|SUPERIORITY_OR_OTHER||Difference from adalimumab|-4.13|||||TWO_SIDED|95.0|-6.55|-1.72||||||Analysis of incidence rate at 24 months. Point estimate and 95% CI. Poisson distribution was used to construct the 95% CIs.||-1.72|-6.55|
91644924|NCT00929864|183181240|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 365|-1.3|||||TWO_SIDED|95.0|-6.5|3.9|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 365.||3.9|-6.5|
91644925|NCT00929864|183181240|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 729|0.9|||||TWO_SIDED|95.0|-5.5|7.3|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 729.||7.3|-5.5|
91644926|NCT00929864|183181241|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.8|||||TWO_SIDED|95.0|-4.51|6.11||||||Analysis for incidence rate of SAE at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||6.11|-4.51|
91644927|NCT00929864|183181241|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.67|||||TWO_SIDED|95.0|-3.27|1.94||||||Analysis for incidence rate of Serious Infections and Infestations at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.94|-3.27|
91644928|NCT00929864|183181241|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.0|||||TWO_SIDED|95.0|-0.92|0.91||||||Analysis for incidence rate of Opportunistic Infections at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.91|-0.92|
91644929|NCT00929864|183181241|SUPERIORITY_OR_OTHER||Difference from adalimumab|-5.32|||||TWO_SIDED|95.0|-12.06|1.41||||||Analysis for incidence rate of discontinuation for any cause at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.41|-12.06|
91644930|NCT00929864|183181242|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.91|||||TWO_SIDED|95.0|-5.43|1.61||||||Analysis for incidence rate of SAE at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.61|-5.43|
91644931|NCT00929864|183181242|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.24|||||TWO_SIDED|95.0|-3.12|0.63||||||Analysis for incidence rate of Serious infections and infestations Adverse Events at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.63|-3.12|
91706987|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||||TWO_SIDED|95.0|-86.79|90.97|||||Comparison of Insulin, iAUC 0-3|||90.97|-86.79|
91644932|NCT00929864|183181242|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.52|||||TWO_SIDED|95.0|-1.39|0.36|||minimum risk weights method|||Analysis for incidence rate of opportunistic infections at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.36|-1.39|
91644933|NCT00929864|183181242|SUPERIORITY_OR_OTHER||Difference from adalimumab|-3.1|||||TWO_SIDED|95.0|-7.13|0.92||||||Analysis for incidence rate of discontinuations (all cause) at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.92|-7.13|
91644934|NCT00929864|183181243|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.1|||||TWO_SIDED|95.0|-13.9|-2.2||||||Analysis for ANA at Day 365. Point estimate and 95% CI for treatment difference.||-2.2|-13.9|
91644935|NCT00929864|183181243|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.4|||||TWO_SIDED|95.0|-15.3|-1.5||||||Analysis for ANA at Day 729. Point estimate and 95% CI for treatment difference||-1.5|-15.3|
91644936|NCT00929864|183181243|SUPERIORITY_OR_OTHER||Difference from adalimumab|-9.6|||||TWO_SIDED|95.0|-13.4|-5.7||||||Analysis for dsDNA at Day 365. Point estimate and 95% CI for treatment difference.||-5.7|-13.4|
91644937|NCT00929864|183181243|SUPERIORITY_OR_OTHER||Difference from adalimumab|-12.2|||||TWO_SIDED|95.0|-16.9|-7.6||||||Analysis for dsDNA at Day 729. Point estimate and 95% CI for treatment difference.||-7.6|-16.9|
91644938|NCT03940742|183181244|OTHER||Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.879|1.32||||||||1.32|0.879|
91644939|NCT03940742|183181244|OTHER||Ratio of geometric least squares mean|0.96|||||TWO_SIDED|90.0|0.79|1.17||||||||1.17|0.790|
91644940|NCT03940742|183181244|OTHER||Ratio of geometric least squares mean|0.852|||||TWO_SIDED|90.0|0.699|1.04||||||||1.04|0.699|
91644941|NCT03940742|183181245|OTHER||Ratio of geometric least squares mean|0.916|||||TWO_SIDED|90.0|0.726|1.16||||||||1.16|0.726|
91771787|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|12.82||||0.0214|TWO_SIDED|95.0|1.46|112.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||112.7|1.46|0.0214
91644942|NCT03940742|183181245|OTHER||Ratio of geometric least squares mean|1.0|||||TWO_SIDED|90.0|0.802|1.25||||||||1.25|0.802|
91644943|NCT03940742|183181245|OTHER||Ratio of geometric least squares mean|0.972|||||TWO_SIDED|90.0|0.784|1.21||||||||1.21|0.784|
91644944|NCT03428217|183181253|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6528|TWO_SIDED|95.0|0.74|1.21|||Log Rank|||Stratified Analysis 1: Stratified by prior programmed cell death protein 1/programmed cell death protein ligand 1 (PD-1/PDL1) inhibitor therapy (yes vs no) and International Metastatic Renal Cell Carcinoma Database (IMDC) prognostic risk group (favorable vs intermediate vs poor).||1.21|0.74|0.6528
91644945|NCT03428217|183181253|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8193|TWO_SIDED|95.0|0.76|1.24|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.24|0.76|0.8193
91644946|NCT03428217|183181253|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8345|TWO_SIDED|95.0|0.76|1.25|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.25|0.76|0.8345
91644947|NCT03428217|183181253|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9479|TWO_SIDED|95.0|0.78|1.27|||Log Rank|||Unstratified Analysis||1.27|0.78|0.9479
91644948|NCT03428217|183181254|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3867|TWO_SIDED|95.0|0.83|1.6|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.6|0.83|0.3867
91644949|NCT03428217|183181254|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3367|TWO_SIDED|95.0|0.85|1.62|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.62|0.85|0.3367
91644950|NCT03428217|183181254|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2416|TWO_SIDED|95.0|0.88|1.69|||Log Rank|||Stratified Analysis 3: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.69|0.88|0.2416
91644951|NCT03428217|183181254|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.3043|TWO_SIDED|95.0|0.86|1.64|||Log Rank|||Unstratified Analysis||1.64|0.86|0.3043
91644952|NCT03428217|183181255|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9692|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.25|0.79|0.9692
91644953|NCT03428217|183181255|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9235|TWO_SIDED|95.0|0.8|1.27|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.27|0.8|0.9235
91644954|NCT03428217|183181255|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9549|TWO_SIDED|95.0|0.8|1.26|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.26|0.8|0.9549
91644955|NCT03428217|183181255|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8193|TWO_SIDED|95.0|0.82|1.29|||Log Rank|||Unstratified Analysis||1.29|0.82|0.8193
91644956|NCT03252015|183181371|SUPERIORITY||Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-0.412|0.049||||||Day 7||0.049|-0.412|
91644957|NCT03252015|183181371|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||Day 7||0.224|-0.081|
91644958|NCT03252015|183181371|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
91644959|NCT03252015|183181371|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
91644960|NCT03252015|183181372|SUPERIORITY||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.34|0.05||||||Day 7||0.050|-0.340|
91644961|NCT03252015|183181372|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||||0.224|-0.081|
91644962|NCT03252015|183181372|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.151|0.294||||||Day 21||0.294|-0.151|
91644963|NCT03252015|183181372|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
91644964|NCT02262507|183181398|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91706988|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-92.47|91.84|||||Comparison of Insulin, iAUC 0-3|||91.84|-92.47|
91644965|NCT00975000|183181401|SUPERIORITY_OR_OTHER||Chi-Square test statistic|66.437|||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and \> 11.2 mg/dL)||The primary endpoint was tested at a significance level of 0.05.||||<0.001
91644966|NCT00975000|183181401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|91.41|||||TWO_SIDED|95.0|18.76|445.41|||||Odds ratio of Cinacalcet/Placebo|||445.41|18.76|
91644967|NCT00975000|183181401|SUPERIORITY_OR_OTHER||Difference|75.44|||||TWO_SIDED|95.0|63.83|87.05|||||Difference = Cinacalcet-Placebo|||87.05|63.83|
91644968|NCT00975000|183181402|SUPERIORITY_OR_OTHER||Difference|1.41||||0.266|TWO_SIDED|95.0|-1.1|3.93|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet - placebo)|||3.93|-1.10|0.266
91644969|NCT00975000|183181403|SUPERIORITY_OR_OTHER||Difference|0.45|||<|0.001|TWO_SIDED|95.0|0.26|0.64|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet - placebo)|||0.64|0.26|<0.001
91644970|NCT00975000|183181404|SUPERIORITY_OR_OTHER||Difference|-0.4||||0.842|TWO_SIDED|95.0|-4.37|3.57|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet - placebo)|||3.57|-4.37|0.842
91644971|NCT00975000|183181405|SUPERIORITY_OR_OTHER||Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.62|-1.16|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet - placebo)|||-1.16|-1.62|<0.001
91644972|NCT00975000|183181406|SUPERIORITY_OR_OTHER||Difference|-117.21||||0.002|TWO_SIDED|95.0|-189.88|-44.55|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet - placebo)|||-44.55|-189.88|0.002
91644973|NCT00975000|183181407|SUPERIORITY_OR_OTHER||Difference|-1.42||||0.846|TWO_SIDED|95.0|-15.91|13.06|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet - placebo)|||13.06|-15.91|0.846
91771788|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.93||||0.6013|TWO_SIDED|95.0|0.16|22.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.99|0.16|0.6013
91519716|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.26|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.26
91519717|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.28|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.28
91644974|NCT00902486|183181415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0619|TWO_SIDED|95.0|0.77|6.15|||Cochran-Armitage trend test||LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics|The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.||6.15|0.77|0.0619
91644975|NCT00902486|183181415|OTHER|||||||0.1978|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.||||0.1978
91644976|NCT00902486|183181415|OTHER|||||||0.0437|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.||||0.0437
91644977|NCT00902486|183181415|OTHER|||||||0.1236|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.||||0.1236
91644978|NCT00526227|183181477|OTHER|An exact one-sided 97% upper confidence bound or a p-value will be calculated based on the observed percentage of subjects with an USADE within the first month post-implant. This rate will be considered acceptable if the one-sided 97% upper confidence bound is less than 10% or, equivalently, if the p-value is less than 0.0304.|Percentage|7.7|||||ONE_SIDED|97.0|||||||The CI was calculated based on 44 patients at interim analysis: 0 USADE were reported within 1-month post implant, ie 0% of subjects experienced a USADE. The one-sided 97% exact binomial upper confidence bound was 7.7% which is lower than 10%.|"H 0 (null hypothesis): P ≥ 10%; H A (alternative hypothesis): P \< 10%, where P is the percentage of subjects experiencing a USADE through the 1-month post implant.~An upper limit of the confidence interval of the percentage subjects with USADE not greater than or equal to 10% at the 1-month follow-up visit provides a reasonably-sized clinical study with sufficient power to detect USADEs."||||
91644979|NCT05257109|183181492|OTHER|Mixed effects models with water concentration as the within subject factor and irritation as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Median Difference (Final Values)|0.67||||0.0014|TWO_SIDED|||||Significant p-value set at \<0.05|Mixed Models Analysis|||||||0.0014
91644980|NCT05257109|183181493|OTHER|Mixed effects models with water concentration as the within subject factor and LHS as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|1.55|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
91644981|NCT05257109|183181494|OTHER|Mixed effects models with water concentration as the within subject factor and DEQ as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|3.28|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
91644982|NCT00858234|183181497|OTHER|Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)|Accumulation ratio|1.08|||||TWO_SIDED|90.0|0.8|1.45|||||Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.|||1.45|0.80|
91644983|NCT02253654|183181548|SUPERIORITY_OR_OTHER||Treatment difference|0.39|STANDARD_ERROR_OF_MEAN|3.53||0.46|ONE_SIDED|97.5|-6.58||||t-test, 1 sided|||The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.|||-6.58|0.46
91644984|NCT00149669|183181568|SUPERIORITY||Odds Ratio (OR)|8.67|||<|0.01|TWO_SIDED|95.0|4.24|17.73|||General Estimating Equation (GEE)|||||17.73|4.24|<0.01
91644985|NCT00149669|183181569|SUPERIORITY||Odds Ratio (OR)|0.91||||0.82|TWO_SIDED|95.0|0.43|1.95|||General Estimating Equation (GEE)|||||1.95|.43|0.82
91644986|NCT00149669|183181570|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.19|TWO_SIDED|95.0|0.29|1.26|||General Estimating Equation (GEE)|||||1.26|0.29|=0.19
91644987|NCT02458365|183181575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.75|.51|<.0001
91644988|NCT02458365|183181575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.68|||Regression, Linear|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.68|.45|<.0001
91644989|NCT02458365|183181576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.57|0.84|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.84|.57|<.001
91644990|NCT02458365|183181576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.75|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.75|.50|<.0001
91644991|NCT02458365|183181577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.43|0.67|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.67|.43|<.0001
91644992|NCT02458365|183181577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.56|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.56|.36|<.0001
91644993|NCT02458365|183181578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.62|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.62|.41|<.0001
91644994|NCT02458365|183181578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.54|.35|<.0001
91644995|NCT02458365|183181579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.38|.001
91644996|NCT02458365|183181579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.90|.40|.013
91644997|NCT02458365|183181580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.76|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.76|.37|<.001
91644998|NCT02458365|183181580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.35|0.82|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.82|.35|.004
91644999|NCT02458365|183181581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.002|TWO_SIDED|95.0|0.35|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.35|.002
91645000|NCT02458365|183181581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.005|TWO_SIDED|95.0|0.31|0.81|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.81|.31|.005
91645001|NCT02458365|183181582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.29|0.64|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.64|.29|<.0001
91645002|NCT02458365|183181582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.003|TWO_SIDED|95.0|0.29|0.77|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.77|.29|.003
91645003|NCT00468312|183181615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
91645004|NCT00468312|183181616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.026
91645005|NCT00468312|183181617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
91645006|NCT00468312|183181618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
91645007|NCT00468312|183181619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.269
91645008|NCT01052038|183181620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||||||<0.001
91645009|NCT01052038|183181620|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
91645010|NCT01052038|183181620|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
91645011|NCT01052038|183181621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Dunn's post hoc-test corrected for 12 comparisons.||||||<0.001
91645012|NCT01052038|183181621|SUPERIORITY_OR_OTHER||Median Difference (Net)|22.0||||0.005|TWO_SIDED|95.0|14.0|29.0|||Wilcoxon (Mann-Whitney)|||||29|14|0.005
91645013|NCT01052038|183181621|SUPERIORITY_OR_OTHER||Median Difference (Net)|14.0||||0.004|TWO_SIDED|95.0|7.0|22.0|||Wilcoxon (Mann-Whitney)|||||22|7|0.004
91645014|NCT01052038|183181622|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared, Corrected|||||||0.004
91645015|NCT01052038|183181623|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|Post hoc test using Dunn's test corrected for 12 comparisons||||||0.01
91645016|NCT01052038|183181623|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003||95.0|0.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|0|0.003
91519718|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.29|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.29
91645017|NCT01052038|183181624|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared, Corrected|||||||0.04
91645018|NCT03349437|183181625|SUPERIORITY|||||||0.02||||||This p-value is in reference to the total Modified 6MWT Distance|Wilcoxon Signed Rank|||||||0.02
91645019|NCT00602641|183181725|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.|Hazard Ratio (HR)|0.84|||||TWO_SIDED|90.0|0.67|1.045|||||Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.|Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.||1.045|0.67|
91645020|NCT00602641|183181726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|TWO_SIDED||||||Log Rank|Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).||||||0.476
91645021|NCT00602641|183181727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|TWO_SIDED||||||Fisher Exact|||||||0.204
91645022|NCT00602641|183181728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
91645023|NCT03901339|183181729|OTHER||Hazard Ratio (HR)|0.653||||0.0001|TWO_SIDED|95.0|0.526|0.812||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.812|0.526|0.0001
91645024|NCT03901339|183181730|OTHER||Hazard Ratio (HR)|0.788||||0.0133|TWO_SIDED|95.0|0.652|0.952||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.952|0.652|0.0133
91645025|NCT03901339|183181731|OTHER||Odds Ratio (OR)|1.662||||0.0268|TWO_SIDED|95.0|1.058|2.609|||Cochran-Mantel-Haenszel|||ORR by BICR Assessment||2.609|1.058|0.0268
91645026|NCT03901339|183181731|OTHER||Odds Ratio (OR)|1.989||||0.0098|TWO_SIDED|95.0|1.174|3.369|||Cochran-Mantel-Haenszel|||ORR by LIR Assessment||3.369|1.174|0.0098
91645027|NCT03901339|183181733|OTHER||Odds Ratio (OR)|1.796||||0.0025|TWO_SIDED|95.0|1.227|2.628|||Cochran-Mantel-Haenszel|||CBR by BICR Assessment||2.628|1.227|0.0025
91645028|NCT03901339|183181733|OTHER||Odds Ratio (OR)|1.834||||0.0024|TWO_SIDED|95.0|1.237|2.717|||Cochran-Mantel-Haenszel|||CBR by LIR Assessment||2.717|1.237|0.0024
91645029|NCT03901339|183181734|OTHER||Hazard Ratio (HR)|0.728||||0.001|TWO_SIDED|95.0|0.602|0.881||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.881|0.602|0.0010
91645030|NCT03901339|183181735|OTHER||Hazard Ratio (HR)|0.751||||0.0059|TWO_SIDED|95.0|0.612|0.922||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.922|0.612|0.0059
91645031|NCT03901339|183181736|OTHER||Hazard Ratio (HR)|0.918||||0.4151|TWO_SIDED|95.0|0.748|1.126||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||1.126|0.748|0.4151
91645032|NCT03901339|183181737|OTHER||Hazard Ratio (HR)|0.732||||0.0021|TWO_SIDED|95.0|0.598|0.894||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.894|0.598|0.0021
91645033|NCT01294709|183181756|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-6.9|||||TWO_SIDED|90.0|-17.66|3.86|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||3.86|-17.66|
91645034|NCT01294709|183181757|SUPERIORITY_OR_OTHER||Difference in Least squares meand|-0.056|||||TWO_SIDED|90.0|-0.19|0.076|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||0.076|-0.19|
91645035|NCT01294709|183181758|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.14|||||TWO_SIDED|90.0|-22.03|7.74|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||7.74|-22.03|
91706989|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.053|||||TWO_SIDED|95.0|-71.8|111.91|||||Comparison of Insulin, iAUC 0-3|||111.91|-71.80|
91645036|NCT00110084|183181787|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|50.0|||||TWO_SIDED|95.0|36.0|64.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||64|36|
91645037|NCT02446496|183181791|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|95.91|||||TWO_SIDED|90.0|85.67|107.37||||||||107.37|85.67|
91645038|NCT02446496|183181792|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|102.31|||||TWO_SIDED|90.0|90.46|115.7|||||Comparison of AUC (0-t) between Treatment A and Treatment B|||115.70|90.46|
91645039|NCT02446496|183181792|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|103.13|||||TWO_SIDED|90.0|91.19|116.62|||||Comparison of AUC(0-infinity) between Treatment A and Treatment B|||116.62|91.19|
91645040|NCT02446496|183181793|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon's Signed-Rank Test|Comparison of T-max between Treatment A and Treatment B.||||||0.2670
91645041|NCT04854707|183181795|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91645042|NCT04854707|183181795|OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91645043|NCT04854707|183181796|OTHER||Mean Difference (Final Values)|0.017||||0.314|TWO_SIDED|95.0|-0.0161|0.0501|||Chi-squared|z-value = 1||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0501|-0.0161|0.314
91645044|NCT04854707|183181796|OTHER||Mean Difference (Final Values)|0.0207||||0.482|TWO_SIDED|95.0|-0.0369|0.0782|||Chi-squared|||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0782|-0.0369|0.482
91645045|NCT04854707|183181797|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91645046|NCT04854707|183181797|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91645047|NCT04854707|183181798|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91645048|NCT04854707|183181799|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91645049|NCT04854707|183181799|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91645050|NCT05302414|183181823|SUPERIORITY||Median Difference (Final Values)|12.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
91645051|NCT05302414|183181823|SUPERIORITY||Median Difference (Final Values)|2.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
91645052|NCT05302414|183181823|SUPERIORITY||Median Difference (Final Values)|6.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
91645053|NCT05302414|183181824|SUPERIORITY||Median Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For pretest at the 0 week||||<0.05
91645054|NCT05302414|183181824|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
91645055|NCT05302414|183181824|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
91645056|NCT05302414|183181825|SUPERIORITY||Median Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
91645057|NCT05302414|183181825|SUPERIORITY||Median Difference (Final Values)|45.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
91645058|NCT05302414|183181825|SUPERIORITY||Median Difference (Final Values)|43.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
91645059|NCT05302414|183181826|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
91645060|NCT05302414|183181826|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
91645061|NCT05302414|183181826|SUPERIORITY||Median Difference (Final Values)|2.5||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
91645062|NCT05302414|183181827|SUPERIORITY||Median Difference (Final Values)|6.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
91645063|NCT05302414|183181827|SUPERIORITY||Median Difference (Final Values)|0.25||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
91645064|NCT05302414|183181827|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
91645065|NCT05302414|183181828|SUPERIORITY||Median Difference (Final Values)|22.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||<0.05
91645066|NCT00742859|183181829|OTHER||Hazard Ratio (HR)|0.14||||0.035|TWO_SIDED|95.0|0.017|1.14|||Log Rank|||Betrixaban 40mg compared to Warfarin||1.14|0.017|0.035
91645067|NCT00742859|183181829|OTHER||Hazard Ratio (HR)|0.711||||0.546|TWO_SIDED|95.0|0.225|2.24|||Log Rank|||Betrixaban 60mg compared to Warfarin||2.24|0.225|0.546
91645068|NCT00742859|183181829|OTHER||Hazard Ratio (HR)|0.755||||0.712|TWO_SIDED|95.0|0.239|2.39|||Log Rank|||Betrixaban 80mg compared to Warfarin||2.39|0.239|0.712
91645069|NCT00742859|183181830|OTHER||Hazard Ratio (HR)|0.508||||0.011|TWO_SIDED|95.0|0.301|0.856|||Log Rank|||Betrixaban 40mg compared to Warfarin||0.856|0.301|0.011
91645070|NCT00742859|183181830|OTHER||Hazard Ratio (HR)|0.767||||0.308|TWO_SIDED|95.0|0.481|1.22|||Log Rank|||Betrixaban 60mg compared to Warfarin||1.22|0.481|0.308
91645071|NCT00742859|183181830|OTHER||Hazard Ratio (HR)|0.551||||0.022|TWO_SIDED|95.0|0.332|0.914|||Log Rank|||Betrixaban 80mg compared to Warfarin||0.914|0.332|0.022
91645072|NCT00956709|183181831|SUPERIORITY_OR_OTHER|||||||0.56||||||Two patients in each group had incomplete block before sugery.|Wilcoxon (Mann-Whitney)|||||||0.56
91645073|NCT00956709|183181833|SUPERIORITY_OR_OTHER|||||||0.3354|||||||Wilcoxon (Mann-Whitney)|||||||0.3354
91645074|NCT00956709|183181834|SUPERIORITY_OR_OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||||||0.0445
91645075|NCT03706209|183181857|SUPERIORITY||Odds Ratio (OR)|4.12||||0.161|TWO_SIDED|95.0|0.47|35.97|||Cochran-Mantel-Haenszel|||||35.97|0.47|0.161
91645076|NCT03706209|183181857|SUPERIORITY||Odds Ratio (OR)|5.52||||0.111|TWO_SIDED|95.0|0.55|55.43|||Cochran-Mantel-Haenszel|||||55.43|0.55|0.111
91645077|NCT03706209|183181858|SUPERIORITY||Odds Ratio (OR)|1.73||||0.222|TWO_SIDED|95.0|0.71|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.71|0.222
91706990|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.606|||||TWO_SIDED|95.0|-57.59|104.8|||||Comparison of Insulin, iAUC 0-3|||104.80|-57.59|
91706991|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.506|||||TWO_SIDED|95.0|-3.13|10.14|||||Comparison of PYY total, AUC 0-2|||10.14|-3.13|
91706992|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.295|||||TWO_SIDED|95.0|0.41|14.18|||||Comparison of PYY total, AUC 0-2|||14.18|0.41|
91706993|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.006|||||TWO_SIDED|95.0|0.15|13.87|||||Comparison of PYY total, AUC 0-2|||13.87|0.15|
91706994|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.555|||||TWO_SIDED|95.0|-8.62|3.51|||||Comparison of PYY total, AUC 0-2|||3.51|-8.62|
91706995|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.523|||||TWO_SIDED|95.0|-2.13|7.17|||||Comparison of PYY total, iAUC 0-2|||7.17|-2.13|
91706996|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.296|||||TWO_SIDED|95.0|0.47|10.12|||||Comparison of PYY total, iAUC 0-2|||10.12|0.47|
91706997|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|||||TWO_SIDED|95.0|-3.08|6.53|||||Comparison of PYY total, iAUC 0-2|||6.53|-3.08|
91706998|NCT01119846|183307989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.506|||||TWO_SIDED|95.0|-7.75|0.74|||||Comparison of PYY total, iAUC 0-2|||0.74|-7.75|
91706999|NCT01119846|183307990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||||TWO_SIDED|95.0|-0.84|1.32||||||||1.32|-0.84|
91707000|NCT01119846|183307990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.523|||||TWO_SIDED|95.0|-0.6|1.64||||||||1.64|-0.60|
91519719|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.23|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.23
91519720|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.45|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.45
91519721|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.24|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.24
91645078|NCT03706209|183181858|SUPERIORITY||Odds Ratio (OR)|1.91||||0.182|TWO_SIDED|95.0|0.75|4.91|||Cochran-Mantel-Haenszel|||||4.91|0.75|0.182
91707001|NCT01119846|183307990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|||||TWO_SIDED|95.0|-1.17|1.06||||||||1.06|-1.17|
91707002|NCT01119846|183307990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.81|1.16||||||||1.16|-0.81|
91707003|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06|||||Comparison of G/I ratio|||0.06|-0.08|
91707004|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
91707005|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
91707006|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.04|0.08|||||Comparison of G/I ratio|||0.08|-0.04|
91707007|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.269|||||TWO_SIDED|95.0|-8.31|12.85|||||Comparison of I/G ratio|||12.85|-8.31|
91707008|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.959|||||TWO_SIDED|95.0|-8.01|13.93|||||Comparison of I/G ratio|||13.93|-8.01|
91707009|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.053|||||TWO_SIDED|95.0|-4.88|16.99|||||Comparison of I/G ratio|||16.99|-4.88|
91707010|NCT01119846|183307991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.017|||||TWO_SIDED|95.0|-5.65|13.68|||||Comparison of I/G ratio|||13.68|-5.65|
91707011|NCT01119846|183307992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||||TWO_SIDED|95.0|-0.28|0.22|||||Comparison of insulin glucose index|||0.22|-0.28|
91707012|NCT01119846|183307992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-0.2|0.31|||||Comparison of insulin glucose index|||0.31|-0.20|
91707013|NCT01119846|183307992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|||||TWO_SIDED|95.0|-0.29|0.23|||||Comparison of insulin glucose index|||0.23|-0.29|
91707014|NCT01119846|183307992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|||||TWO_SIDED|95.0|-0.27|0.19|||||Comparison of insulin glucose index|||0.19|-0.27|
91707015|NCT01119846|183307993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|||||TWO_SIDED|95.0|-2.06|1.37||||||||1.37|-2.06|
91707016|NCT01119846|183307993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-1.82|1.73||||||||1.73|-1.82|
91707017|NCT01119846|183307993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.388|||||TWO_SIDED|95.0|-2.16|1.38||||||||1.38|-2.16|
91707018|NCT01119846|183307993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|||||TWO_SIDED|95.0|-1.43|1.7||||||||1.70|-1.43|
91707019|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.523|||||TWO_SIDED|95.0|-3.04|2.0|||||Comparison of Day 7, 1 Hour|||2.00|-3.04|
91707020|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.569|||||TWO_SIDED|95.0|-3.07|1.94|||||Comparison of Day 7, 1 Hour|||1.94|-3.07|
91707021|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.064|||||TWO_SIDED|95.0|-0.45|4.57|||||Comparison of Day 7, 1 Hour|||4.57|-0.45|
91707022|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.316|||||TWO_SIDED|95.0|-2.19|2.82|||||Comparison of Day 7, 1 Hour|||2.82|-2.19|
91707023|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.484|||||TWO_SIDED|95.0|-3.99|1.02|||||Comparison of Day 7, 1 Hour|||1.02|-3.99|
91707024|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.795|||||TWO_SIDED|95.0|-3.27|1.68|||||Comparison of Day 7, 2 Hours|||1.68|-3.27|
91519722|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.28|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.28
91645079|NCT03706209|183181859|SUPERIORITY||Odds Ratio (OR)|2.91||||0.294|TWO_SIDED|95.0|0.33|25.39|||Cochran-Mantel-Haenszel|||||25.39|0.33|0.294
91645080|NCT03706209|183181859|SUPERIORITY||Odds Ratio (OR)|4.06||||0.291|TWO_SIDED|95.0|0.31|53.14|||Cochran-Mantel-Haenszel|||||53.14|0.31|0.291
91645081|NCT03706209|183181860|SUPERIORITY||Odds Ratio (OR)|1.31||||0.617|TWO_SIDED|95.0|0.45|3.77|||Cochran-Mantel-Haenszel|||||3.77|0.45|0.617
91645082|NCT03706209|183181860|SUPERIORITY||Odds Ratio (OR)|1.73||||0.319|TWO_SIDED|95.0|0.6|5.0|||Cochran-Mantel-Haenszel|||||5|0.6|0.319
91645083|NCT03706209|183181861|SUPERIORITY||Odds Ratio (OR)|1.5||||0.47|TWO_SIDED|95.0|0.5|4.52|||Cochran-Mantel-Haenszel|||||4.52|0.5|0.47
91645084|NCT03706209|183181861|SUPERIORITY||Odds Ratio (OR)|2.44||||0.136|TWO_SIDED|95.0|0.76|7.82|||Cochran-Mantel-Haenszel|||||7.82|0.76|0.136
91645085|NCT03706209|183181862|SUPERIORITY||least square means|0.2|STANDARD_ERROR_OF_MEAN|1.4||0.894|TWO_SIDED|95.0|-2.6|3.0|||ANCOVA|||||3|-2.6|0.894
91645086|NCT03706209|183181862|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.4||0.456|TWO_SIDED|95.0|-3.8|1.7|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.7|-3.8|0.456
91645087|NCT03706209|183181864|SUPERIORITY|||||||0.572|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.572
91645088|NCT03706209|183181864|SUPERIORITY|||||||0.4494|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.4494
91645089|NCT03706209|183181865|SUPERIORITY|||||||0.7922|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.7922
91645090|NCT03706209|183181865|SUPERIORITY|||||||0.1425|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.1425
91645091|NCT03706209|183181866|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.992|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.992
91645092|NCT03706209|183181866|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.143|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.143
91645093|NCT03706209|183181869|SUPERIORITY|||||||0.178|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.178
91645094|NCT03706209|183181869|SUPERIORITY||Odds Ratio (OR)|0.63||||0.718|TWO_SIDED|95.0|0.05|7.48|||Cochran-Mantel-Haenszel|||||7.48|0.05|0.718
91645095|NCT03706209|183181870|SUPERIORITY||Odds Ratio (OR)|2.4||||0.474|TWO_SIDED|95.0|0.21|28.05|||Cochran-Mantel-Haenszel|||||28.05|0.21|0.474
91645096|NCT03706209|183181870|SUPERIORITY||Odds Ratio (OR)|1.25||||0.867|TWO_SIDED|95.0|0.08|19.05|||Cochran-Mantel-Haenszel|||||19.05|0.08|0.867
91645097|NCT03706209|183181871|SUPERIORITY||Odds Ratio (OR)|2.2||||0.375|TWO_SIDED|95.0|0.38|12.84|||Cochran-Mantel-Haenszel|||||12.84|0.38|0.375
91645098|NCT03706209|183181871|SUPERIORITY||Odds Ratio (OR)|4.24||||0.116|TWO_SIDED|95.0|0.66|27.08|||Cochran-Mantel-Haenszel|||||27.08|0.66|0.116
91645099|NCT03706209|183181872|SUPERIORITY||Odds Ratio (OR)|0.41||||0.287|TWO_SIDED|95.0|0.08|2.27|||Cochran-Mantel-Haenszel|||||2.27|0.08|0.287
91645100|NCT03706209|183181872|SUPERIORITY||Odds Ratio (OR)|1.85||||0.332|TWO_SIDED|95.0|0.53|6.4|||Cochran-Mantel-Haenszel|||||6.4|0.53|0.332
91645101|NCT03706209|183181873|SUPERIORITY||Odds Ratio (OR)|0.81||||0.719|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.719
91645102|NCT03706209|183181873|SUPERIORITY||Odds Ratio (OR)|1.72||||0.357|TWO_SIDED|95.0|0.55|5.32|||Cochran-Mantel-Haenszel|||||5.32|0.55|0.357
91645103|NCT03706209|183181874|SUPERIORITY||Odds Ratio (OR)|1.75||||0.355|TWO_SIDED|95.0|0.53|5.72|||Cochran-Mantel-Haenszel|||||5.72|0.53|0.355
91645104|NCT03706209|183181874|SUPERIORITY||Odds Ratio (OR)|2.22||||0.198|TWO_SIDED|95.0|0.67|7.37|||Cochran-Mantel-Haenszel|||||7.37|0.67|0.198
91645105|NCT03706209|183181875|SUPERIORITY||least square means|0.3|STANDARD_ERROR_OF_MEAN|1.0||0.757|TWO_SIDED|95.0|-1.7|2.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||2.3|-1.7|0.757
91645106|NCT03706209|183181875|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.0||0.267|TWO_SIDED|95.0|-3.1|0.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||0.9|-3.1|0.267
91645107|NCT03706209|183181876|SUPERIORITY||least square means|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.412|TWO_SIDED|95.0|-1.4|3.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.4|-1.4|0.412
91645108|NCT03706209|183181876|SUPERIORITY||least square means|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.401|TWO_SIDED|95.0|-3.5|1.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.4|-3.5|0.401
91645109|NCT03706209|183181877|SUPERIORITY||least square means|0.4|STANDARD_ERROR_OF_MEAN|1.7||0.801|TWO_SIDED|95.0|-3.0|3.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.9|-3|0.801
91645110|NCT03706209|183181877|SUPERIORITY||least square means|0.1|STANDARD_ERROR_OF_MEAN|1.7||0.957|TWO_SIDED|95.0|-3.4|3.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.3|-3.4|0.957
91645111|NCT03706209|183181881|SUPERIORITY||Odds Ratio (OR)|1.45||||0.45|TWO_SIDED|95.0|0.55|3.8|||Cochran-Mantel-Haenszel|||||3.8|0.55|0.45
91645112|NCT03706209|183181881|SUPERIORITY||Odds Ratio (OR)|1.97||||0.186|TWO_SIDED|95.0|0.74|5.26|||Cochran-Mantel-Haenszel|||||5.26|0.74|0.186
91645113|NCT03706209|183181882|SUPERIORITY||Odds Ratio (OR)|0.94||||0.884|TWO_SIDED|95.0|0.41|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.41|0.884
91645114|NCT03706209|183181882|SUPERIORITY||Odds Ratio (OR)|1.49||||0.384|TWO_SIDED|95.0|0.61|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.61|0.384
91645115|NCT03706209|183181883|SUPERIORITY||Odds Ratio (OR)|1.64||||0.311|TWO_SIDED|95.0|0.63|4.26|||Cochran-Mantel-Haenszel|||||4.26|0.63|0.311
91645116|NCT03706209|183181883|SUPERIORITY||Odds Ratio (OR)|1.21||||0.699|TWO_SIDED|95.0|0.47|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.47|0.699
91645117|NCT03706209|183181884|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.671|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.671
91645118|NCT03706209|183181884|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.183|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.183
91645119|NCT03706209|183181885|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.542|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.542
91645120|NCT03706209|183181885|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.328|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.328
91645121|NCT03706209|183181886|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.921|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.921
91645122|NCT03706209|183181886|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.488|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.488
91645123|NCT03706209|183181897|SUPERIORITY|||||||0.1193|||||||Fisher Exact|||||||0.1193
91645124|NCT03706209|183181897|SUPERIORITY|||||||0.0054|||||||Fisher Exact|||||||0.0054
91645125|NCT03706209|183181898|SUPERIORITY|||||||0.2439|||||||Fisher Exact|||||||0.2439
91645126|NCT03706209|183181898|SUPERIORITY|||||||0.2461|||||||Fisher Exact|||||||0.2461
91645127|NCT03706209|183181899|SUPERIORITY|||||||0.4395|||||||Fisher Exact|||||||0.4395
91645128|NCT03706209|183181899|SUPERIORITY|||||||0.0593|||||||Fisher Exact|||||||0.0593
91645129|NCT03706209|183181901|SUPERIORITY|||||||0.0507|||||||Fisher Exact|||||||0.0507
91645130|NCT03706209|183181901|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||||||0.0005
91645131|NCT03706209|183181902|SUPERIORITY|||||||0.0504|||||||Fisher Exact|||||||0.0504
91645132|NCT03706209|183181902|SUPERIORITY|||||||0.0013|||||||Fisher Exact|||||||0.0013
91645133|NCT03706209|183181903|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
91645134|NCT03706209|183181903|SUPERIORITY|||||||0.0032|||||||Fisher Exact|||||||0.0032
91645135|NCT00038467|183181916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||3e-05|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|0.00003
91645136|NCT00038467|183181917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913||||0.15737|TWO_SIDED|95.0|0.806|1.036|||Log Rank|||||1.036|0.806|0.15737
91645137|NCT00038467|183181919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|||<|0.0001|TWO_SIDED|95.0|1.63|3.23|||t-test, 2 sided|||6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.23|1.63|<0.0001
91645138|NCT00038467|183181919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.0002|TWO_SIDED|95.0|0.57|1.79|||t-test, 2 sided|||6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||1.79|0.57|0.0002
91645139|NCT00038467|183181919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.79|||<|0.0001|TWO_SIDED|95.0|1.77|3.81|||t-test, 2 sided|||12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.81|1.77|<0.0001
91645140|NCT00038467|183181919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||<|0.0001|TWO_SIDED|95.0|1.12|2.46|||t-test, 2 sided|||12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.46|1.12|<0.0001
91645141|NCT00038467|183181919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||<|0.0001|TWO_SIDED|95.0|2.1|4.35|||t-test, 2 sided|||24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||4.35|2.10|<0.0001
91645142|NCT00038467|183181919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.0001|TWO_SIDED|95.0|1.1|2.69|||t-test, 2 sided|||24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.69|1.10|<0.0001
91645143|NCT00038467|183181928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.5|TWO_SIDED|95.0|-1.76|0.86|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.86|-1.76|0.500
91645144|NCT00038467|183181928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.009|TWO_SIDED|95.0|-3.67|-0.52|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.52|-3.67|0.009
91645145|NCT00038467|183181928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.079|TWO_SIDED|95.0|-2.86|0.16|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.16|-2.86|0.079
91645146|NCT00038467|183181928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.729|TWO_SIDED|95.0|-1.24|1.77|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.77|-1.24|0.729
91645147|NCT00038467|183181928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.302|TWO_SIDED|95.0|-2.43|0.75|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.75|-2.43|0.302
91645148|NCT00038467|183181928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.187|TWO_SIDED|95.0|-2.76|0.54|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.54|-2.76|0.187
91645149|NCT00038467|183181929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.26|TWO_SIDED|95.0|-1.8|0.49|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.49|-1.80|0.260
91645150|NCT00038467|183181929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.209|TWO_SIDED|95.0|-2.02|0.44|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.44|-2.02|0.209
91645151|NCT00038467|183181929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.698|TWO_SIDED|95.0|-1.38|0.92|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.92|-1.38|0.698
91645152|NCT00038467|183181929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.192|TWO_SIDED|95.0|-0.42|2.09|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||2.09|-0.42|0.192
91645153|NCT00038467|183181929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.813|TWO_SIDED|95.0|-1.46|1.15|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||1.15|-1.46|0.813
91645154|NCT00038467|183181929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.537|TWO_SIDED|95.0|-0.91|1.75|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||1.75|-0.91|0.537
91645155|NCT00038467|183181930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.727|TWO_SIDED|95.0|-3.46|2.42|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||2.42|-3.46|0.727
91645156|NCT00038467|183181930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.047|TWO_SIDED|95.0|-6.12|-0.05|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.05|-6.12|0.047
91645157|NCT00038467|183181930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.553|TWO_SIDED|95.0|-3.88|2.08|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||2.08|-3.88|0.553
91645158|NCT00038467|183181930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.563|TWO_SIDED|95.0|-2.17|3.99|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||3.99|-2.17|0.563
91645159|NCT00038467|183181930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.643|TWO_SIDED|95.0|-3.83|2.36|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||2.36|-3.83|0.643
91645160|NCT00038467|183181930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.91||||0.126|TWO_SIDED|95.0|-6.63|0.82|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.82|-6.63|0.126
91645161|NCT00038467|183181931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.265|TWO_SIDED|95.0|-0.83|0.23|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.23|-0.83|0.265
91645162|NCT00038467|183181931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.0002|TWO_SIDED|95.0|-1.84|-0.57|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.57|-1.84|0.0002
91645163|NCT00038467|183181931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.132|TWO_SIDED|95.0|-1.0|0.13|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.13|-1.00|0.132
91645164|NCT00038467|183181931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.635|TWO_SIDED|95.0|-0.7|0.43|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.43|-0.70|0.635
91645165|NCT00038467|183181931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.449|TWO_SIDED|95.0|-0.75|0.33|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.33|-0.75|0.449
91645166|NCT00038467|183181931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.454|TWO_SIDED|95.0|-0.81|0.36|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.36|-0.81|0.454
91645167|NCT00038467|183181932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.712|TWO_SIDED|95.0|-0.53|0.335|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.335|-0.53|0.712
91645168|NCT00038467|183181932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.899|TWO_SIDED|95.0|-0.65|0.356|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.356|-0.65|0.899
91519723|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.26|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.26
91645169|NCT00038467|183181932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.882|TWO_SIDED|95.0|-0.76|0.359|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.359|-0.76|0.882
91645170|NCT00038467|183181932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.604|TWO_SIDED|95.0|-0.54|0.37|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.37|-0.54|0.604
91645171|NCT00038467|183181932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.562|TWO_SIDED|95.0|-1.16|0.454|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.454|-1.16|0.562
91645172|NCT00038467|183181933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.892|TWO_SIDED|95.0|-0.2|0.18|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.18|-0.20|0.892
91645173|NCT00038467|183181933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.881|TWO_SIDED|95.0|-0.21|0.24|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.24|-0.21|0.881
91645174|NCT00038467|183181933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.883|TWO_SIDED|95.0|-0.18|0.21|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.21|-0.18|0.883
91645175|NCT00038467|183181933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.604|TWO_SIDED|95.0|-0.16|0.27|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.27|-0.16|0.604
91645176|NCT00038467|183181933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.118|TWO_SIDED|95.0|-0.05|0.41|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.41|-0.05|0.118
91645177|NCT00038467|183181933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.307|TWO_SIDED|95.0|-0.11|0.34|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.34|-0.11|0.307
91645178|NCT00038467|183181934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.792|TWO_SIDED|95.0|-0.42|0.56|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.56|-0.42|0.792
91645179|NCT00038467|183181934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.405|TWO_SIDED|95.0|-0.76|0.31|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.31|-0.76|0.405
91645180|NCT00038467|183181934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.484|TWO_SIDED|95.0|-0.75|0.36|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.36|-0.75|0.484
91645181|NCT00038467|183181934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.229|TWO_SIDED|95.0|-0.19|0.8|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.80|-0.19|0.229
91645182|NCT00038467|183181934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.381|TWO_SIDED|95.0|-0.84|0.32|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.32|-0.84|0.381
91645183|NCT00038467|183181934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.405|TWO_SIDED|95.0|-0.82|0.33|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.33|-0.82|0.405
91645184|NCT00038467|183181935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.648|TWO_SIDED|95.0|-0.77|0.48|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.48|-0.77|0.648
91707025|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.313|||||TWO_SIDED|95.0|-2.78|2.15|||||Comparison of Day 7, 2 Hours|||2.15|-2.78|
91519724|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.41|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.41
91519725|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.46
91519726|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.43|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.43
91519727|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.36|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.36
91519728|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.39|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.39
91519729|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.42|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.42
91519730|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.42|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.42
91519731|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.35|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.35
91519732|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.58|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.58
91519733|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.36|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.36
91519734|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.41|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.41
91519735|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.66|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.66
91519736|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.66|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.66
91519737|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.91|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.91
91519738|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.79|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.79
91519739|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.84|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.84
91645185|NCT00038467|183181935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.366|TWO_SIDED|95.0|-1.08|0.4|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.40|-1.08|0.366
91519740|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.81|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.81
91581631|NCT02349425|183053229|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0026|TWO_SIDED|95.0|-2.2|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.2|0.0026
91645186|NCT00038467|183181935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.062|TWO_SIDED|95.0|-1.33|0.03|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.03|-1.33|0.062
91771789|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0537|TWO_SIDED|95.0|0.97|76.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||76.58|0.97|0.0537
91645187|NCT00038467|183181935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.545|TWO_SIDED|95.0|-0.53|1.0|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.00|-0.53|0.545
91645188|NCT00038467|183181935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.932|TWO_SIDED|95.0|-0.77|0.7|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.70|-0.77|0.932
91645189|NCT00038467|183181935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.244|TWO_SIDED|95.0|-1.24|0.32|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.32|-1.24|0.244
91645190|NCT00038467|183181936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.876|TWO_SIDED|95.0|-0.62|0.73|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.73|-0.62|0.876
91645191|NCT00038467|183181936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.195|TWO_SIDED|95.0|-1.25|0.26|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.26|-1.25|0.195
91645192|NCT00038467|183181936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.63|TWO_SIDED|95.0|-0.92|0.55|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.55|-0.92|0.630
91645193|NCT00038467|183181936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.53|TWO_SIDED|95.0|-0.5|0.98|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.98|-0.50|0.530
91645194|NCT00038467|183181936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.147|TWO_SIDED|95.0|-1.43|0.21|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.21|-1.43|0.147
91645195|NCT00038467|183181936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.389|TWO_SIDED|95.0|-1.18|0.46|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.46|-1.18|0.389
91645196|NCT00038467|183181938|SUPERIORITY_OR_OTHER|||||||0.0174|TWO_SIDED||||||Chi-squared|||6 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0174
91645197|NCT00038467|183181938|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Chi-squared|||12 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0059
91645198|NCT00038467|183181938|SUPERIORITY_OR_OTHER|||||||0.0037|TWO_SIDED||||||Chi-squared|||24 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0037
91645199|NCT00038467|183181938|SUPERIORITY_OR_OTHER|||||||0.8084|TWO_SIDED||||||Chi-squared|||12 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.8084
91645200|NCT00038467|183181938|SUPERIORITY_OR_OTHER|||||||0.6449|TWO_SIDED||||||Chi-squared|||24 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.6449
91645201|NCT03972709|183181944|SUPERIORITY||Difference in Adjusted Means|0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1206||95.0|-0.08|0.66|||MMRM|||||0.66|-0.08|0.1206
91645202|NCT03972709|183181944|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6127||95.0|-0.34|0.57|||MMRM|||||0.57|-0.34|0.6127
91645203|NCT03972709|183181951|SUPERIORITY||Difference in Adjusted Means|-0.39|STANDARD_ERROR_OF_MEAN|1.901||0.8388|TWO_SIDED|95.0|-4.14|3.36|||MMRM|||||3.36|-4.14|0.8388
91645204|NCT03972709|183181951|SUPERIORITY||Difference in Adjusted Means|-0.48|STANDARD_ERROR_OF_MEAN|2.384||0.8412|TWO_SIDED|95.0|-5.18|4.23|||MMRM|||||4.23|-5.18|0.8412
91645205|NCT03972709|183181952|SUPERIORITY||Difference in Adjusted Means|0.83|STANDARD_ERROR_OF_MEAN|2.052||0.6865|TWO_SIDED|95.0|-3.22|4.88|||MMRM|||||4.88|-3.22|0.6865
91645206|NCT03972709|183181952|SUPERIORITY||Difference in Adjusted Means|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.9355||95.0|-4.73|5.13|||MMRM|||||5.13|-4.73|0.9355
91645207|NCT01523301|183181953|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.12|||=|0.1286|TWO_SIDED|95.0|-2.56|0.33||The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.|ANCOVA|||The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.||0.33|-2.56|=0.1286
91645208|NCT00728988|183181965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9237|TWO_SIDED|95.0|-7.3|9.3|||Chi-squared, Corrected||95% confidence interval for the true difference in the incidence of MACE between the two treatment groups. Difference of incidence = usual care minus atorvastatin.|Total MACE: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.3|-7.3|0.9237
91645209|NCT00728988|183181965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-10.7|10.7|||Fisher Exact||Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin.|Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher's exact test was applied because the expected frequency of events was less than 5.||10.7|-10.7|1.0000
91645210|NCT00728988|183181965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9158|TWO_SIDED|95.0|-7.2|9.2|||Chi-squared, Corrected||Difference of incidence = usual care minus atorvastatin.|Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.2|-7.2|0.9158
91645211|NCT00728988|183181965|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.5104|1.6846|||Regression, Logistic|||Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care.||1.6846|0.5104|0.80
91707026|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.441|||||TWO_SIDED|95.0|-0.03|4.91|||||Comparison of Day 7, 2 Hours|||4.91|-0.03|
91645212|NCT00728988|183181965|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.9|TWO_SIDED|95.0|0.4887|1.8836|||Regression, Logistic|||Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF \<=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care.||1.8836|0.4887|0.90
91645213|NCT00728988|183181965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8494|TWO_SIDED||||||Log Rank|Survival analysis: Kaplan-Meier log rank test.||MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups.||||0.8494
91645214|NCT00728988|183181966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||1|TWO_SIDED|95.0|-5.6|6.3|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care.|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.3|-5.6|1.0000
91645215|NCT00728988|183181967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.7896|TWO_SIDED|95.0|-9.7|6.5|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care .|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.5|-9.7|0.7896
91645216|NCT00728988|183181968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4||||0.631|TWO_SIDED|95.0|-10.1|5.4|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.4|-10.1|0.631
91645217|NCT00728988|183181968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.518|TWO_SIDED|95.0|-12.1|5.5|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.5|-12.1|0.518
91645218|NCT00728988|183181968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.236|TWO_SIDED|95.0|-9.6|12.0|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||12.0|-9.6|0.236
91645219|NCT00728988|183181969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.425|TWO_SIDED|95.0|-6.2|15.9|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||15.9|-6.2|0.425
91645220|NCT00728988|183181969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.392|TWO_SIDED|95.0|-6.1|16.7|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||16.7|-6.1|0.392
91645221|NCT00728988|183181969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-10.7|10.9|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||10.9|-10.7|1.000
91645222|NCT00728988|183181970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.529|TWO_SIDED|95.0|-9.6|4.3|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||4.3|-9.6|0.529
91645223|NCT00728988|183181970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.827|TWO_SIDED|95.0|-5.8|3.6|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||3.6|-5.8|0.827
91519741|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.76|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.76
91519742|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.84|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.84
91519743|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.83|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.83
91645224|NCT00728988|183181970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.616|TWO_SIDED|95.0|-10.3|11.5|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||11.5|-10.3|0.616
91645225|NCT00728988|183181971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.53||||0.7554|TWO_SIDED|95.0|-215.87|156.81|||ANOVA|||8 hours post-PCI: difference (% change).||156.81|-215.87|0.7554
91645226|NCT00728988|183181971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.58||||0.7436|TWO_SIDED|95.0|-253.42|354.58|||ANOVA|||24 hours post-PCI: difference (% change).||354.58|-253.42|0.7436
91645227|NCT00728988|183181971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-58.22||||0.4741|TWO_SIDED|95.0|-218.12|101.68|||ANOVA|||30 days post-PCI: difference (% change).||101.68|-218.12|0.4741
91645228|NCT00116207|183181972|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.32
91645229|NCT00116207|183181972|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24-MONTH||||0.045
91645230|NCT00116207|183181973|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.52
91645231|NCT00116207|183181973|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.82
91645232|NCT00116207|183181974|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.24
91645233|NCT00116207|183181975|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.83
91645234|NCT00345969|183182059|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91645235|NCT00345969|183182060|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
91645236|NCT00345969|183182061|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANOVA|||||||0.23
91645237|NCT00345969|183182062|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||||||0.43
91645238|NCT00345969|183182063|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||ANOVA|||||||0.33
91645239|NCT00345969|183182064|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||ANOVA|||||||0.93
91645240|NCT00345969|183182065|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||||||0.24
91645241|NCT00345969|183182066|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANOVA|||||||0.49
91645242|NCT00345969|183182067|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||||||0.19
91645243|NCT00345969|183182068|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
91645244|NCT00345969|183182069|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANOVA|||||||0.44
91645245|NCT00345969|183182070|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
91645246|NCT00345969|183182071|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
91645247|NCT00609115|183182072|SUPERIORITY||Effect size|0.65||||0.01|TWO_SIDED|97.5|||||ANCOVA|||||||0.010
91645248|NCT00609115|183182072|SUPERIORITY||Effect|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
91645249|NCT00609115|183182073|SUPERIORITY||Effect Size|0.0||||1|TWO_SIDED|95.0||||The reported p-value was calculated.|ANCOVA|||||||1.00
91645250|NCT00609115|183182073|SUPERIORITY||Effect Size|-0.29||||0.06|TWO_SIDED|95.0|||||ANCOVA|||||||0.06
91645251|NCT00609115|183182074|SUPERIORITY||Effect Size|0.33||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
91645252|NCT00609115|183182074|SUPERIORITY||Effect Size|0.4||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
91645253|NCT00609115|183182075|SUPERIORITY||Effect Size|0.05||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
91645254|NCT00609115|183182075|SUPERIORITY||Effect Size|-0.27||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
91645255|NCT00609115|183182076|SUPERIORITY||Effect Size|0.25||||0.28|TWO_SIDED|95.0|||||ANCOVA|||||||0.28
91645256|NCT00609115|183182076|SUPERIORITY||Effect Size|0.38||||0.09|TWO_SIDED|95.0|||||ANCOVA|||||||0.09
91645257|NCT00609115|183182077|SUPERIORITY||Effect Size|0.23||||0.18|TWO_SIDED|95.0|||||ANCOVA|||||||0.18
91645258|NCT00609115|183182077|SUPERIORITY||Effect Size|0.37||||0.1|TWO_SIDED|95.0|||||ANCOVA|||||||0.10
91645259|NCT00609115|183182078|SUPERIORITY||Effect Size|0.18||||0.45|TWO_SIDED|95.0|||||ANCOVA|||||||0.45
91645260|NCT00609115|183182078|SUPERIORITY||Effect Size|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
91645261|NCT00609115|183182079|SUPERIORITY||Effect Size|-0.17||||0.47|TWO_SIDED|95.0|||||ANCOVA|||||||0.47
91645262|NCT00609115|183182079|SUPERIORITY||Effect Size|0.77||||0.015|TWO_SIDED|95.0|||||ANCOVA|||||||0.015
91645263|NCT00609115|183182080|SUPERIORITY||Effect Size|0.48||||0.05|TWO_SIDED|95.0|||||ANCOVA|||||||0.05
91645264|NCT00609115|183182080|SUPERIORITY||Effect Size|0.56||||0.002|TWO_SIDED|95.0|||||ANCOVA|||||||0.002
91645265|NCT00609115|183182081|SUPERIORITY||Effect Size|0.26||||0.27|TWO_SIDED|95.0|||||ANCOVA|||||||0.27
91645266|NCT00609115|183182081|SUPERIORITY||Effect Size|0.45||||0.045|TWO_SIDED|95.0|||||ANCOVA|||||||0.045
91645267|NCT00584831|183182083|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645268|NCT00584831|183182083|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hyposthesis is that visual acuity is the same for all lens types.||||0.02
91645269|NCT00584831|183182083|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645270|NCT00584831|183182083|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645271|NCT00584831|183182083|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645272|NCT00584831|183182083|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645273|NCT00584831|183182084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645274|NCT00584831|183182084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645275|NCT00584831|183182084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645276|NCT00584831|183182084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91707027|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884|||||TWO_SIDED|95.0|-1.58|3.34|||||Comparison of Day 7, 2 Hours|||3.34|-1.58|
91707028|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.222|||||TWO_SIDED|95.0|-3.69|1.24|||||Comparison of Day 7, 2 Hours|||1.24|-3.69|
91707029|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|||||TWO_SIDED|95.0|-2.06|2.03|||||Comparison of Day 7, 4 Hours|||2.03|-2.06|
91707030|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-1.56|2.51|||||Comparison of Day 7, 4 Hours|||2.51|-1.56|
91707031|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.512|||||TWO_SIDED|95.0|-0.53|3.55|||||Comparison of Day 7, 4 Hours|||3.55|-0.53|
91707032|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.233|||||TWO_SIDED|95.0|-0.8|3.26|||||Comparison of Day 7, 4 Hours|||3.26|-0.80|
91707033|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.011|||||TWO_SIDED|95.0|-3.05|1.02|||||Comparison of Day 7, 4 Hours|||1.02|-3.05|
91707034|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.189|||||TWO_SIDED|95.0|-3.05|2.67|||||Comparison of Day 7, 6 Hours|||2.67|-3.05|
91707035|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|||||TWO_SIDED|95.0|-2.39|3.3|||||Comparison of Day 7, 6 Hours|||3.30|-2.39|
91707036|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.706|||||TWO_SIDED|95.0|-0.14|5.56|||||Comparison of Day 7, 6 Hours|||5.56|-0.14|
91707037|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.062|||||TWO_SIDED|95.0|-1.78|3.91|||||Comparison of Day 7, 6 Hours|||3.91|-1.78|
91707038|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.708|||||TWO_SIDED|95.0|-5.55|0.14|||||Comparison of Day 7, 6 Hours|||0.14|-5.55|
91707039|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||||TWO_SIDED|95.0|-2.41|2.7|||||Comparison of Day 7, 10 Hours|||2.70|-2.41|
91707040|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.452|||||TWO_SIDED|95.0|-2.09|2.99|||||Comparison of Day 7, 10 Hours|||2.99|-2.09|
91707041|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.418|||||TWO_SIDED|95.0|-0.13|4.96|||||Comparison of Day 7, 10 Hours|||4.96|-0.13|
91707042|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.063|||||TWO_SIDED|95.0|-1.47|3.6|||||Comparison of Day 7, 10 Hours|||3.60|-1.47|
91707043|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.509|||||TWO_SIDED|95.0|-4.05|1.03|||||Comparison of Day 7, 10 Hours|||1.03|-4.05|
91707044|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-4.2|1.6|||||Comparison of Day 7, 12 Hours|||1.60|-4.20|
91707045|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.325|||||TWO_SIDED|95.0|-4.21|1.56|||||Comparison of Day 7, 12 Hours|||1.56|-4.21|
91707046|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.89|3.89|||||Comparison of Day 7, 12 Hours|||3.89|-1.89|
91707047|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.265|||||TWO_SIDED|95.0|-3.14|2.62|||||Comparison of Day 7, 12 Hours|||2.62|-3.14|
91707048|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.516|||||TWO_SIDED|95.0|-3.4|2.37|||||Comparison of Day 7, 12 Hours|||2.37|-3.40|
91707049|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.515|||||TWO_SIDED|95.0|-2.29|1.26|||||Comparison of Day 14, 24 Hours|||1.26|-2.29|
91707050|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.225|||||TWO_SIDED|95.0|-1.99|1.55|||||Comparison of Day 14, 24 Hours|||1.55|-1.99|
91707051|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.501|||||TWO_SIDED|95.0|-1.28|2.28|||||Comparison of Day 14, 24 Hours|||2.28|-1.28|
91707052|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.168|||||TWO_SIDED|95.0|-1.98|1.65|||||Comparison of Day 14, 24 Hours|||1.65|-1.98|
91707053|NCT01119846|183307994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.043|||||TWO_SIDED|95.0|-2.81|0.73|||||Comparison of Day 14, 24 Hours|||0.73|-2.81|
91707054|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.457|||||TWO_SIDED|95.0|-214.72|73.8|||||Day 7, 1 Hour|||73.80|-214.72|
91707055|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-151.722|||||TWO_SIDED|95.0|-295.98|-7.46|||||Day 7, 1 Hour|||-7.46|-295.98|
91707056|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-69.113|||||TWO_SIDED|95.0|-213.48|75.25|||||Day 7, 1 Hour|||75.25|-213.48|
91707057|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.468|||||TWO_SIDED|95.0|-248.72|39.78|||||Day 7, 1 Hour|||39.78|-248.72|
91707058|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-118.462|||||TWO_SIDED|95.0|-263.93|27.01|||||Day 7, 1 Hour|||27.01|-263.93|
91707059|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-114.34|||||TWO_SIDED|95.0|-264.78|36.1|||||Day 7, 2 Hours|||36.10|-264.78|
91707060|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-116.462|||||TWO_SIDED|95.0|-266.9|33.98|||||Day 7, 2 Hours|||33.98|-266.90|
91707061|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.201|||||TWO_SIDED|95.0|-154.75|146.35|||||Day 7, 2 Hours|||146.35|-154.75|
91707062|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.27|||||TWO_SIDED|95.0|-198.7|102.16|||||Day 7, 2 Hours|||102.16|-198.70|
91707063|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.605|||||TWO_SIDED|95.0|-202.31|101.1|||||Day 7, 2 Hours|||101.10|-202.31|
91707064|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.231|||||TWO_SIDED|95.0|-40.84|26.38|||||Day 7, 4 Hours|||26.38|-40.84|
91707065|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.025|||||TWO_SIDED|95.0|-38.63|28.58|||||Day 7, 4 Hours|||28.58|-38.63|
91707066|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.523|||||TWO_SIDED|95.0|-24.11|43.16|||||Day 7, 4 Hours|||43.16|-24.11|
91707067|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.618|||||TWO_SIDED|95.0|-36.22|30.99|||||Day 7, 4 Hours|||30.99|-36.22|
91707068|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.8|||||TWO_SIDED|95.0|-13.09|54.69|||||Day 7, 4 Hours|||54.69|-13.09|
91707069|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.864|||||TWO_SIDED|95.0|-156.11|38.38|||||Day 7, 6 Hours|||38.38|-156.11|
91707070|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.9|||||TWO_SIDED|95.0|-175.15|19.35|||||Day 7, 6 Hours|||19.35|-175.15|
91707071|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.323|||||TWO_SIDED|95.0|-69.0|125.65|||||Day 7, 6 Hours|||125.65|-69.00|
91707072|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.499|||||TWO_SIDED|95.0|-121.74|72.74|||||Day 7, 6 Hours|||72.74|-121.74|
91707073|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.755|||||TWO_SIDED|95.0|-157.82|38.31|||||Day 7, 6 Hours|||38.31|-157.82|
91707074|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-69.85|69.4|||||Day 7, 10 Hours|||69.40|-69.85|
91707075|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-77.28|61.98|||||Day 7, 10 Hours|||61.98|-77.28|
91707076|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.148|||||TWO_SIDED|95.0|-62.55|76.85|||||Day 7, 10 Hours|||76.85|-62.55|
91707077|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.734|||||TWO_SIDED|95.0|-36.89|102.36|||||Day 7, 10 Hours|||102.36|-36.89|
91707078|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.76|||||TWO_SIDED|95.0|-81.01|61.49|||||Day 7, 10 Hours|||61.49|-81.01|
91707079|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.594|||||TWO_SIDED|95.0|-123.36|84.18|||||Day 7, 12 Hours|||84.18|-123.36|
91707080|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.924|||||TWO_SIDED|95.0|-150.69|56.85|||||Day 7, 12 Hours|||56.85|-150.69|
91707081|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.715|||||TWO_SIDED|95.0|-79.16|128.59|||||Day 7, 12 Hours|||128.59|-79.16|
91707082|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.966|||||TWO_SIDED|95.0|-111.73|95.8|||||Day 7, 12 Hours|||95.80|-111.73|
91707083|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.108|||||TWO_SIDED|95.0|-103.08|109.29|||||Day 7, 12 Hours|||109.29|-103.08|
91707084|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.114|||||TWO_SIDED|95.0|-25.12|4.89|||||Day 14, 24 Hours|||4.89|-25.12|
91707085|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.718|||||TWO_SIDED|95.0|-23.71|6.28|||||Day 14, 24 Hours|||6.28|-23.71|
91707086|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.622|||||TWO_SIDED|95.0|-15.63|14.38|||||Day 14, 24 Hours|||14.38|-15.63|
91707087|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.454|||||TWO_SIDED|95.0|-27.78|2.88|||||Day 14, 24 Hours|||2.88|-27.78|
91707088|NCT01119846|183307995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.681|||||TWO_SIDED|95.0|-24.02|6.66|||||Day 14, 24 Hours|||6.66|-24.02|
91707089|NCT00212264|183308027|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||.001
91707090|NCT00212264|183308028|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 1 sided|Note that the no-treatment control group completed the study after 2 months and was not included in this analysis of treatment effect durability.||||||.32
91707091|NCT00187278|183308029|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926||||0.3492|TWO_SIDED|95.0|0.789|1.0088||adjusted p|Regression, Cox|||||1.0088|0.789|0.3492
91707092|NCT00187278|183308030|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.0882|TWO_SIDED|95.0|0.756|1.02||adjusted p|Regression, Cox|||||1.020|0.756|0.0882
91707093|NCT00187278|183308031|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8215|TWO_SIDED|95.0|0.74|1.27|||Regression, Cox|||||1.27|0.74|0.8215
91707094|NCT04424914|183308074|OTHER|||||||0.3006|||||||Chi-squared|p-values for comparison of proportions of CLASS I+II vs CLASS III+IV were based on a Chi-square test.||||||0.3006
91707095|NCT04424914|183308075|OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
91707096|NCT02195427|183308094|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Global Action and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|97.5|-0.17|0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||0.11|-0.17|
91707097|NCT02195427|183308094|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Deep Lines and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|97.5|-0.25|0.06|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline"||0.06|-0.25|
91519744|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.94|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.94
91707098|NCT03782974|183308109|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.104|<|0.0001|TWO_SIDED|95.0|-0.77|-0.37||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.37|-0.77|<0.0001
91707099|NCT03782974|183308110|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|95.0|0.1|0.59||The threshold for statistical significance was p=0.05.|Chi-squared|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||0.59|0.10|<0.0001
91707100|NCT03782974|183308111|SUPERIORITY||Least Square Mean Difference|6.35|||<|0.001|TWO_SIDED|95.0|3.93|8.77||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||8.77|3.93|<0.001
91707101|NCT03782974|183308112|SUPERIORITY||Least Square Mean Difference|4.049|||<|0.05|TWO_SIDED|95.0|1.08|7.01||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||7.01|1.08|<0.05
91707102|NCT03782974|183308113|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.6
91707103|NCT03782974|183308114|SUPERIORITY|||||||0.054||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.054
91707104|NCT03782974|183308115|SUPERIORITY|||||||0.13||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.13
91707105|NCT03782974|183308116|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.96|-0.56||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.56|-0.96|<0.0001
91707106|NCT00136214|183308117|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.08
91707107|NCT00136214|183308117|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Mi/Cr at time points 1,2 and 3||||0.3
91707108|NCT00136214|183308117|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.9
91707109|NCT00136214|183308117|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.7
91707110|NCT00136214|183308117|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1,2 and 3||||0.4
91707111|NCT00136214|183308117|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.6
91707112|NCT00136214|183308117|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.3
91707113|NCT00136214|183308117|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy ofMI/Cr at time points 1,2 and 3||||0.3
91707114|NCT00136214|183308117|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.3
91707115|NCT00136214|183308117|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.4
91707116|NCT00136214|183308117|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.9
91707117|NCT00136214|183308117|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
91707118|NCT00136214|183308117|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.7
91707119|NCT00136214|183308117|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.1
91707120|NCT00136214|183308117|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
91707121|NCT00136214|183308117|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.5
91707122|NCT00136214|183308117|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.4
91707123|NCT00136214|183308117|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Crat time points 1 and 2||||0.9
91707124|NCT00136214|183308118|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for HVLT||||>0.05
91707125|NCT00136214|183308118|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for ROCF||||< 0.05
91707126|NCT00136214|183308118|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for HVLT||||>0.05
91707127|NCT00136214|183308118|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for ROCF||||>0.05
91707128|NCT04985942|183308119|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-6.38|-3.44|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-3.44|-6.38|<0.0001
91707129|NCT04985942|183308120|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.85|-0.48|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-0.48|-0.85|<0.0001
91707130|NCT02757352|183308123|SUPERIORITY||Odds Ratio (OR)|2.36||||0.009|TWO_SIDED|95.0|1.23|4.51|||Regression, Logistic|||||4.51|1.23|0.009
91707131|NCT02757352|183308123|SUPERIORITY||Odds Ratio (OR)|2.78||||0.002|TWO_SIDED|95.0|1.48|5.25|||Regression, Logistic|||||5.25|1.48|0.002
91707132|NCT02757352|183308124|SUPERIORITY||Odds Ratio (OR)|2.82||||0.004|TWO_SIDED|95.0|1.38|5.77|||Regression, Logistic|||||5.77|1.38|0.004
91707133|NCT02757352|183308124|SUPERIORITY||Odds Ratio (OR)|2.85||||0.004|TWO_SIDED|95.0|1.4|5.77|||Regression, Logistic|||||5.77|1.40|0.004
91707134|NCT02757352|183308125|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.81|-0.28|||Mixed Models Analysis|||||-0.28|-0.81|<0.001
91707135|NCT02757352|183308125|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED|95.0|-0.94|-0.41|||Mixed Models Analysis|||||-0.41|-0.94|<0.001
91707136|NCT02757352|183308126|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|95.0|-0.96|-0.26|||Mixed Models Analysis|||||-0.26|-0.96|<0.001
91707137|NCT02757352|183308126|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||||-0.34|-1.05|<0.001
91707138|NCT02757352|183308128|SUPERIORITY||LS Mean Difference|2.8509|STANDARD_ERROR_OF_MEAN|1.139||0.013|TWO_SIDED|95.0|0.6092|5.0926|||Mixed Models Analysis|||||5.0926|0.6092|0.013
91707139|NCT02757352|183308128|SUPERIORITY||LS Mean Difference|2.7497|STANDARD_ERROR_OF_MEAN|1.1278||0.015|TWO_SIDED|95.0|0.5299|4.9694|||Mixed Models Analysis|||||4.9694|0.5299|0.015
91707140|NCT02757352|183308129|SUPERIORITY||LS Mean Difference|4.2001|STANDARD_ERROR_OF_MEAN|1.6467||0.012|TWO_SIDED|95.0|0.9525|7.4477|||Mixed Models Analysis|||||7.4477|0.9525|0.012
91707141|NCT02757352|183308129|SUPERIORITY||LS Mean Difference|4.6081|STANDARD_ERROR_OF_MEAN|1.6455||0.006|TWO_SIDED|95.0|1.3629|7.8533|||Mixed Models Analysis|||||7.8533|1.3629|0.006
91707142|NCT02757352|183308130|SUPERIORITY||Odds Ratio (OR)|2.73||||0.008|TWO_SIDED|95.0|1.3|5.76|||Regression, Logistic|||||5.76|1.30|0.008
91707143|NCT02757352|183308130|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|1.66|7.08|||Regression, Logistic|||||7.08|1.66|<0.001
91707144|NCT02757352|183308131|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.02|10.41|||Regression, Logistic|||||10.41|2.02|<0.001
91707145|NCT02757352|183308131|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.76|9.05|||Regression, Logistic|||||9.05|1.76|<0.001
91771790|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.8||||0.2662|TWO_SIDED|95.0|0.36|39.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||39.91|0.36|0.2662
91707146|NCT02757352|183308132|SUPERIORITY||LS Means Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.308||0.031|TWO_SIDED|95.0|-1.28|-0.06|||Mixed Models Analysis|||||-0.06|-1.28|0.031
91707147|NCT02757352|183308132|SUPERIORITY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.305||0.001|TWO_SIDED|95.0|-1.61|-0.41|||Mixed Models Analysis|||||-0.41|-1.61|0.001
91707148|NCT02757352|183308133|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.404||0.006|TWO_SIDED|95.0|-1.92|-0.33|||Mixed Models Analysis|||||-0.33|-1.92|0.006
91707149|NCT02757352|183308133|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.404||0.002|TWO_SIDED|95.0|-2.08|-0.49|||Mixed Models Analysis|||||-0.49|-2.08|0.002
91707150|NCT02757352|183308134|SUPERIORITY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|0.764|<|0.001|TWO_SIDED|95.0|-4.58|-1.57|||ANCOVA|||||-1.57|-4.58|<0.001
91707151|NCT02757352|183308134|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|0.751|<|0.001|TWO_SIDED|95.0|-5.68|-2.72|||ANCOVA|||||-2.72|-5.68|<0.001
91707152|NCT02757352|183308135|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.621||0.849|TWO_SIDED|95.0|-1.35|1.11|||Mixed Models Analysis|||||1.11|-1.35|0.849
91707153|NCT02757352|183308135|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.608||0.648|TWO_SIDED|95.0|-1.48|0.93|||Mixed Models Analysis|||||0.93|-1.48|0.648
91707154|NCT02757352|183308136|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.443||0.018|TWO_SIDED|95.0|-1.93|-0.18|||Mixed Models Analysis|||||-0.18|-1.93|0.018
91707155|NCT02757352|183308136|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.442||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||||-0.31|-2.05|0.008
91707156|NCT02757352|183308137|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0011|TWO_SIDED|96.0|1.47|19.4|||Regression, Logistic|||||19.40|1.47|0.0011
91707157|NCT02757352|183308137|SUPERIORITY||Odds Ratio (OR)|4.22||||0.031|TWO_SIDED|95.0|1.14|15.66|||Regression, Logistic|||||15.66|1.14|0.031
91707158|NCT02757352|183308138|SUPERIORITY||LS Mean Difference|-3.807|STANDARD_ERROR_OF_MEAN|2.8507||0.183|TWO_SIDED|95.0|-9.418|1.804|||Mixed Models Analysis|||||1.804|-9.418|0.183
91707159|NCT02757352|183308138|SUPERIORITY||LS Mean Difference|-2.743|STANDARD_ERROR_OF_MEAN|2.8202||0.331|TWO_SIDED|95.0|-8.294|2.807|||Mixed Models Analysis|||||2.807|-8.294|0.331
91707160|NCT02757352|183308139|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.148||0.008|TWO_SIDED|95.0|-0.69|-0.1|||Mixed Models Analysis|||||-0.10|-0.69|0.008
91707161|NCT02757352|183308139|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.148||0.038|TWO_SIDED|95.0|-0.6|-0.02|||Mixed Models Analysis|||||-0.02|-0.60|0.038
91707162|NCT02757352|183308140|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.325||0.871|TWO_SIDED|95.0|-0.59|0.7|||Mixed Models Analysis|||||0.70|-0.59|0.871
91707163|NCT02757352|183308140|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.327||0.295|TWO_SIDED|95.0|-0.3|0.99|||Mixed Models Analysis|||||0.99|-0.30|0.295
91707164|NCT02757352|183308141|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.406||0.257|TWO_SIDED|95.0|-1.26|0.34|||Mixed Models Analysis|||||0.34|-1.26|0.257
91707165|NCT02757352|183308141|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.402||0.057|TWO_SIDED|95.0|-1.56|0.02|||Mixed Models Analysis|||||0.02|-1.56|0.057
91707166|NCT02757352|183308142|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.496||0.082|TWO_SIDED|95.0|-1.85|0.11|||Mixed Models Analysis|||||0.11|-1.85|0.082
91707167|NCT02757352|183308142|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.493||0.088|TWO_SIDED|95.0|-1.82|0.13|||Mixed Models Analysis|||||0.13|-1.82|0.088
91707168|NCT02757352|183308143|SUPERIORITY||LS Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|1.442||0.219|TWO_SIDED|95.0|-4.66|1.09|||Mixed Models Analysis|||TJC||1.09|-4.66|0.219
91707169|NCT02757352|183308143|SUPERIORITY||LS Mean Difference|-3.53|STANDARD_ERROR_OF_MEAN|1.388||0.013|TWO_SIDED|95.0|-6.3|-0.76|||Mixed Models Analysis|||TJC||-0.76|-6.30|0.013
91707170|NCT02757352|183308143|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.355||0.009|TWO_SIDED|95.0|-1.68|-0.26|||Mixed Models Analysis|||SJC||-0.26|-1.68|0.009
91707171|NCT02757352|183308143|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.348||0.034|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||SJC||-0.06|-1.46|0.034
91707172|NCT02757352|183308145|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.325|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||||0.5|-1.5|0.325
91707173|NCT02757352|183308145|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.206|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||||0.4|-1.6|0.206
91707174|NCT02757352|183308146|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.601||0.33|TWO_SIDED|95.0|-1.77|0.6|||Mixed Models Analysis|||||0.60|-1.77|0.330
91707175|NCT02757352|183308146|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.11|TWO_SIDED|95.0|-2.15|0.22|||Mixed Models Analysis|||||0.22|-2.15|0.110
91707176|NCT02757352|183308147|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.348
91645277|NCT00584831|183182084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91707177|NCT02757352|183308147|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.82||0.386|TWO_SIDED|95.0|-2.3|0.9|||Mixed Models Analysis|||||0.9|-2.3|0.386
91707178|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-13.76|STANDARD_ERROR_OF_MEAN|4.835||0.005|TWO_SIDED|95.0|-23.32|-4.2|||ANCOVA|||Overall Impairment Score||-4.20|-23.32|0.005
91707179|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|4.697||0.183|TWO_SIDED|95.0|-15.58|3.0|||ANCOVA|||Overall Impairment Score||3.00|-15.58|0.183
91707180|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.114||0.06|TWO_SIDED|95.0|-12.05|0.26|||ANCOVA|||Percentage of absenteeism||0.26|-12.05|0.060
91707181|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-4.15|STANDARD_ERROR_OF_MEAN|3.098||0.182|TWO_SIDED|95.0|-10.27|1.97|||ANCOVA|||Percentage of absenteeism||1.97|-10.27|0.182
91707182|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-13.61|STANDARD_ERROR_OF_MEAN|4.558||0.003|TWO_SIDED|95.0|-22.62|-4.6|||ANCOVA|||Percentage of presentism||-4.60|-22.62|0.003
91707183|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|4.446||0.164|TWO_SIDED|95.0|-15.0|2.58|||ANCOVA|||Percentage of presentism||2.58|-15.00|0.164
91707184|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-10.63|STANDARD_ERROR_OF_MEAN|3.669||0.004|TWO_SIDED|95.0|-17.85|-3.41|||LS Mean Difference|||Percentage of Impairment in Activities Performed Outside of Work||-3.41|-17.85|0.004
91707185|NCT02757352|183308148|SUPERIORITY||LS Mean Difference|-9.99|STANDARD_ERROR_OF_MEAN|3.621||0.006|TWO_SIDED|95.0|-17.12|-2.86|||ANCOVA|||Percentage of Impairment in Activities Performed Outside of Work||-2.86|-17.12|0.006
91707186|NCT01212159|183308173|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Comparison of mean reduction in LDL cholesterol between no monitor (control) and monitor (intervention) groups|t-test, 2 sided|||Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groups||||0.391
91707187|NCT02085070|183308194|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% response|29.7|||||TWO_SIDED|95.0|15.9|47.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from NSCLC. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||47.0|15.9|
91707188|NCT02085070|183308194|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% of patients|26.0|||||TWO_SIDED|95.0|10.0|48.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from melanoma. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||48.0|10.0|
91707189|NCT02815267|183308203|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.06||0.0083|TWO_SIDED|95.0|0.72|4.88|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.||4.88|0.72|0.0083
91707190|NCT02815267|183308204|SUPERIORITY||Risk Difference (RD)|3.33|STANDARD_ERROR_OF_MEAN|2.48||0.1805|TWO_SIDED|95.0|-1.54|8.19||P-value is for the null hypothesis that the combined risk difference equals 0.|Cochran-Mantel-Haenszel|||||8.19|-1.54|0.1805
91771791|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.51||||0.7431|TWO_SIDED|95.0|0.13|17.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||17.84|0.13|0.7431
91581632|NCT02349425|183053229|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0405|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-2.2|0.0405
91707191|NCT02815267|183308205|SUPERIORITY|Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|Mean Difference (Final Values)|12.73|STANDARD_ERROR_OF_MEAN|4.42||0.004|TWO_SIDED|95.0|4.07|21.39|||ANCOVA|||||21.39|4.07|0.0040
91707192|NCT02815267|183308206|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.03||0.0002|TWO_SIDED|95.0|1.85|5.87|||ANCOVA|||||5.87|1.85|0.0002
91707193|NCT02815267|183308206|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.38|6.4|||ANCOVA|||||6.40|2.38|<.0001
91707194|NCT02815267|183308207|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6|Risk Difference (RD)|2.71|STANDARD_ERROR_OF_MEAN|1.32||0.0395|TWO_SIDED|95.0|0.13|5.3|||Cochran-Mantel-Haenszel|||||5.3|0.13|0.0395
91707195|NCT02815267|183308207|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.|Risk Difference (RD)|2.76|STANDARD_ERROR_OF_MEAN|1.55||0.0748|TWO_SIDED|95.0|-0.28|5.8|||Cochran-Mantel-Haenszel|||||5.80|-0.28|0.0748
91707196|NCT00527124|183308234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907|STANDARD_ERROR_OF_MEAN|0.2973||0.7428|TWO_SIDED|95.0|0.506|1.624|||Regression, Cox|||||1.624|0.506|0.7428
91707197|NCT00527124|183308234|SUPERIORITY_OR_OTHER|||||||0.7425|TWO_SIDED|95.0|||||Log Rank|||||||0.7425
91707198|NCT04677387|183308287|SUPERIORITY||Mean Difference (Final Values)|-0.00325||||0.473|TWO_SIDED||||||Regression, Linear|Linear regression using a Generalized Estimating Equation (GEE) model clustering on pharmacy.||||||0.473
91707199|NCT04677387|183308288|SUPERIORITY|||||||0.007|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||.007
91707200|NCT04677387|183308289|SUPERIORITY|||||||0.002|||||||Regression, Linear|Linear regression with a Generalized Estimating Equation (GEE) model.||||||.002
91707201|NCT04677387|183308290|SUPERIORITY|||||||0.169|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||0.169
91707202|NCT00548249|183308298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.999|TWO_SIDED|95.0|0.3|3.32||p-value not adjusted for multiple comparisons|Log Rank|||Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model||3.32|0.30|0.999
91645278|NCT00584831|183182084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91707203|NCT00548249|183308298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.17||||0.807|TWO_SIDED|95.0|0.33|4.09|||Log Rank|||||4.09|0.33|0.807
91707204|NCT00548249|183308298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.8||||0.748|TWO_SIDED|95.0|0.21|3.02|||Log Rank|||||3.02|0.21|0.748
91707205|NCT00548249|183308298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.77||||0.299|TWO_SIDED|95.0|0.6|5.19|||Log Rank|||||5.19|0.60|0.299
91707206|NCT00548249|183308299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.234||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect.||||0.234
91645279|NCT00584831|183182085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.13||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91707207|NCT00548249|183308299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.049
91707208|NCT00548249|183308299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.375
91707209|NCT00548249|183308299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.625
91707210|NCT02007278|183308314|NON_INFERIORITY_OR_EQUIVALENCE|Power=95%; significance level=5%, characteristic operation curves were used with a non-central F distribution for the calculation of the sample size||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
91707211|NCT04475718|183308331|OTHER|Preliminary Efficacy|||||<|0.001|||||||t-test, 2 sided|||||||<.001
91645280|NCT00584831|183182085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91707212|NCT02651688|183308336|SUPERIORITY|||||||0.7103|||||||Wilcoxon rank-sum test|||||||0.7103
91707213|NCT02651688|183308336|SUPERIORITY|||||||0.4529|||||||Wilcoxon rank-sum test|||||||0.4529
91707214|NCT02651688|183308337|SUPERIORITY|||||||0.9302|||||||Wilcoxon rank-sum test|||||||0.9302
91707215|NCT02651688|183308337|SUPERIORITY|||||||0.7509|||||||Wilcoxon rank-sum test|||||||0.7509
91707216|NCT02651688|183308338|SUPERIORITY|||||||0.5095|||||||Wilcoxon rank-sum test|||||||0.5095
91707217|NCT02651688|183308338|SUPERIORITY|||||||0.623|||||||Wilcoxon rank-sum test|||||||0.6230
91707218|NCT02651688|183308339|SUPERIORITY|||||||0.296|||||||Wilcoxon rank-sum test|||||||0.2960
91707219|NCT02651688|183308339|SUPERIORITY|||||||0.2723|||||||Wilcoxon rank-sum test|||||||0.2723
91707220|NCT02651688|183308340|SUPERIORITY|||||||0.0034|||||||Wilcoxon rank-sum test|||||||0.0034
91707221|NCT02651688|183308340|SUPERIORITY|||||||0.0027|||||||Wilcoxon rank-sum test|||||||0.0027
91707222|NCT02651688|183308341|SUPERIORITY|||||||0.0146|||||||Wilcoxon rank-sum test|||||||0.0146
91707223|NCT02651688|183308341|SUPERIORITY|||||||0.0018|||||||Wilcoxon rank-sum test|||||||0.0018
91707224|NCT02651688|183308342|SUPERIORITY|||||||0.1524|||||||Wilcoxon rank-sum test|||||||0.1524
91707225|NCT02651688|183308342|SUPERIORITY|||||||0.0227|||||||Wilcoxon rank-sum test|||||||0.0227
91707226|NCT02651688|183308343|SUPERIORITY|||||||0.5873|||||||Wilcoxon rank-sum test|||||||0.5873
91707227|NCT02651688|183308343|SUPERIORITY|||||||0.9509|||||||Wilcoxon rank-sum test|||||||0.9509
91707228|NCT02651688|183308344|SUPERIORITY|||||||0.4341|||||||Wilcoxon rank-sum test|||||||0.4341
91707229|NCT02651688|183308344|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.0000
91707230|NCT02651688|183308345|SUPERIORITY|||||||0.022|||||||Wilcoxon rank-sum test|||||||0.0220
91707231|NCT02651688|183308345|SUPERIORITY|||||||0.3677|||||||Wilcoxon rank-sum test|||||||0.3677
91707232|NCT02651688|183308346|SUPERIORITY|||||||0.9074|||||||Wilcoxon rank-sum test|||||||0.9074
91707233|NCT02651688|183308346|SUPERIORITY|||||||0.4517|||||||Wilcoxon rank-sum test|||||||0.4517
91707234|NCT02651688|183308347|SUPERIORITY|||||||0.2962|||||||Wilcoxon rank-sum test|||||||0.2962
91707235|NCT02651688|183308347|SUPERIORITY|||||||0.3261|||||||Wilcoxon rank-sum test|||||||0.3261
91707236|NCT02651688|183308348|SUPERIORITY|||||||0.045|||||||Wilcoxon rank-sum test|||||||0.0450
91707237|NCT02651688|183308348|SUPERIORITY|||||||0.2235|||||||Wilcoxon rank-sum test|||||||0.2235
91707238|NCT02651688|183308349|SUPERIORITY|||||||0.826|||||||Wilcoxon rank-sum test|||||||0.8260
91519745|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.84|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.84
91707239|NCT02651688|183308349|SUPERIORITY|||||||0.4183|||||||Wilcoxon rank-sum test|||||||0.4183
91707240|NCT02651688|183308350|SUPERIORITY|||||||0.1144|||||||Wilcoxon rank-sum test|||||||0.1144
91707241|NCT02651688|183308350|SUPERIORITY|||||||0.3263|||||||Wilcoxon rank-sum test|||||||0.3263
91707242|NCT02651688|183308351|SUPERIORITY|||||||0.1546|||||||Wilcoxon rank-sum test|||||||0.1546
91707243|NCT02651688|183308351|SUPERIORITY|||||||0.5732|||||||Wilcoxon rank-sum test|||||||0.5732
91519746|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.81|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.81
91707244|NCT02651688|183308352|SUPERIORITY|||||||0.5581|||||||Wilcoxon rank-sum test|||||||0.5581
91707245|NCT02651688|183308352|SUPERIORITY|||||||0.5833|||||||Wilcoxon rank-sum test|||||||0.5833
91707246|NCT02651688|183308353|SUPERIORITY|||||||0.0168|||||||Wilcoxon rank-sum test|||||||0.0168
91581633|NCT02349425|183053230|SUPERIORITY||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|1.88|5.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.80|1.88|<0.001
91707247|NCT02651688|183308353|SUPERIORITY|||||||0.0364|||||||Wilcoxon rank-sum test|||||||0.0364
91707248|NCT02651688|183308354|SUPERIORITY|||||||0.0992|||||||Wilcoxon rank-sum test|||||||0.0992
91707249|NCT02651688|183308354|SUPERIORITY|||||||0.1333|||||||Wilcoxon rank-sum|||||||0.1333
91707250|NCT02651688|183308355|SUPERIORITY|||||||0.0139|||||||Wilcoxon rank-sum test|||||||0.0139
91707251|NCT02651688|183308355|SUPERIORITY|||||||0.0225|||||||Wilcoxon rank-sum test|||||||0.0225
91707252|NCT03409120|183308358|SUPERIORITY||||||<|0.001|||||||linear mixed effects model|||We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.||||<0.001
91707253|NCT02670382|183308359|SUPERIORITY||mean values, log transformed|||||0.33|||||||Mixed Models Analysis|||||||0.33
91707254|NCT02670382|183308359|SUPERIORITY||mean difference, log transformed values|||||0.92|||||||Mixed Models Analysis|||||||0.92
91707255|NCT02670382|183308359|SUPERIORITY||mean difference, log transformed values|||||0.44|||||||Mixed Models Analysis|||||||0.44
91707256|NCT02670382|183308360|SUPERIORITY||mean difference, log transformed values|||||0.34|||||||Mixed Models Analysis|||||||0.34
91707257|NCT02670382|183308360|SUPERIORITY||mean difference, log transformed values|||||0.5|||||||Mixed Models Analysis|||||||0.50
91707258|NCT02670382|183308360|SUPERIORITY||mean differences, log transformed values|||||0.83|||||||Mixed Models Analysis|||||||0.83
91707259|NCT02670382|183308361|EQUIVALENCE|primary hypothesis is that EPA will not differ from placebo|mean differences|||||0.1|||||||Mixed Models Analysis|||||||0.10
91707260|NCT02670382|183308361|SUPERIORITY||mean difference|||||0.005|||||||Mixed Models Analysis|||||||0.005
91707261|NCT02670382|183308361|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
91707262|NCT00386425|183308395|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for change to Day 7|t-test, 2 sided|||||||0.011
91707263|NCT00386425|183308396|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value is for the moderate Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.047
91707264|NCT00386425|183308396|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for the severe Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.063
91707265|NCT00386425|183308397|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for Day 28 mortality|Fisher Exact|||||||0.030
91707266|NCT00386425|183308398|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||p-value is for Day 90 mortality|Fisher Exact|||||||0.090
91707267|NCT00386425|183308399|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for total SOFA difference between alternative and standard therapy|t-test, 2 sided|||||||0.190
91707268|NCT00386425|183308399|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||p-value is for difference in cardiovascular SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.268
91707269|NCT00386425|183308399|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is for difference in respiratory SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.082
91707270|NCT00386425|183308399|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value is for difference in renal SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.367
91707271|NCT00386425|183308399|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||p-value is for difference in hematology SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.274
91707272|NCT00386425|183308399|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||p-value is for difference in liver SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.341
91707273|NCT00386425|183308401|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for difference between participants normalizing protein C and not normalizing protein C.|Fisher Exact|||||||<0.0001
91707274|NCT00386425|183308402|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||p-value is for 28-Day Mortality, Dead at Day 28 vs. Alive at Day 28|Pearson's chi-square test|||||||0.622
91707275|NCT00386425|183308402|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for Hospital Mortality|Fisher Exact|||||||0.815
91707276|NCT01907217|183308404|NON_INFERIORITY_OR_EQUIVALENCE|"The prespecified noninferiority margin was no more than a -4 point difference at the end of treatment between the bilateral and unilateral groups.~The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\] = -1.67 to 3.84."|Mean Difference (Final Values)|1.08|||<|0.05|TWO_SIDED|95.0|-1.67|3.84||Primary statistical analysis was assessment of difference in HAM-D scores between arms at end-of-treatment, supplemented by 95% CIs and this interval compared with the pre-specified noninferiority threshold (-4 points). The p-value was calculated.|Regression, Linear|A regression model was fitted to end-of-treatment HAM-D measures, with baseline HAM-D scores, trial arm, randomization stratifiers as covariates.|The prespecified noninferiority margin was no more than a -4-point difference at the end of treatment between bitemporal and unilateral groups. The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\]=-1.67 to 3.84).|Based on a large bitemporal ECT series, we estimated that 69 patients were required per group to have 80% power to demonstrate, using a one-sided equivalence t test at 5% level, that the mean reduction in the 24-item HAM-D score following high-dose unilateral ECT was no more than 4 points (i.e., equivalent to 3 points on the 17-item HAM-D, deemed to be clinically relevant \[30\]) less than that achieved using bitemporal ECT.||3.84|-1.67|<0.05
91707277|NCT01907217|183308405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.001|TWO_SIDED|95.0|0.51|0.85||As above|generalized linear models with a binomia|||"The AMI-SF at end of treatment was analyzed using generalized linear models with a binomial distribution and logit-link. Post treatment AMI-SF measures provide the number of baseline items recalled after ECT; such number of items recalled variables were therefore modeled as arising from binomial distributions, with maximum number of possible recalls set to the number of items obtained at baseline."||0.85|0.51|0.001
91707278|NCT01907217|183308406|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.78|||Regression, Linear|Analyzed using a generalized linear models with a binomial distribution and logit-link.||||0.78|0.45|0.001
91707279|NCT01907217|183308407|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.79|||Regression, Linear|generalized linear models with a binomial distribution and logit-link||||0.79|0.45|0.001
91707280|NCT03704948|183308408|SUPERIORITY||Mean Difference (Net)|0.82|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91707281|NCT04607980|183308411|EQUIVALENCE|Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the mean difference of PASI percent improvement from Baseline to Week 12 between ABP 654 versus (vs) ustekinumab with an equivalence margin of (-15, +15).|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-3.16|3.43||||||Multiple imputation was applied for the point estimate and CI of the mean difference between the 2 groups.||3.43|-3.16|
91707282|NCT04607980|183308412|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using analysis of covariance (ANCOVA) model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-2.05|5.94||||||"Week 4: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||5.94|-2.05|
91707283|NCT04607980|183308412|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-2.97|3.31||||||"Week 16: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||3.31|-2.97|
91707284|NCT04607980|183308412|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|-1.39|4.07||||||"Week 28: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||4.07|-1.39|
91707285|NCT04607980|183308412|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-5.46|7.98||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||7.98|-5.46|
91707286|NCT04607980|183308412|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-3.71|||||TWO_SIDED|95.0|-10.71|3.28||||||"Week 44: Treatment Group A vs Treatment Group B.~Observed data was used."||3.28|-10.71|
91645281|NCT00584831|183182085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91707287|NCT04607980|183308412|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-8.45|7.13||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||7.13|-8.45|
91707288|NCT04607980|183308412|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-3.42|0.59||||||"Week 40: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.59|-3.42|
91710567|NCT02634983|183313760|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.982|TWO_SIDED|90.0|-0.62|0.6|||t-test, 2 sided|||Lung Clearance Index||0.60|-0.62|0.9820
91707289|NCT04607980|183308412|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-3.17|1.48||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.48|-3.17|
91707290|NCT04607980|183308412|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-3.29|2.17||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||2.17|-3.29|
91707291|NCT04607980|183308412|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.46|3.86||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||3.86|-2.46|
91707292|NCT04607980|183308413|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.2|||||TWO_SIDED|95.0|-4.02|6.42||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||6.42|-4.02|
91707293|NCT04607980|183308413|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.32|||||TWO_SIDED|95.0|-7.87|7.23||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||7.23|-7.87|
91707294|NCT04607980|183308413|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.82|||||TWO_SIDED|95.0|-5.75|7.37||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||7.37|-5.75|
91707295|NCT04607980|183308413|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.75|||||TWO_SIDED|95.0|-2.37|9.84||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||9.84|-2.37|
91707296|NCT04607980|183308413|EQUIVALENCE|Response difference in dose intensification participants (ABP 654 - ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint.|Response difference|-3.19|||||TWO_SIDED|95.0|-28.15|21.76||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||21.76|-28.15|
91707297|NCT04607980|183308413|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.1|||||TWO_SIDED|95.0|-3.74|7.54||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||7.54|-3.74|
91707298|NCT04607980|183308413|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.85|||||TWO_SIDED|95.0|-4.89|8.39||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||8.39|-4.89|
91707299|NCT04607980|183308413|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.75|||||TWO_SIDED|95.0|-8.61|4.41||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||4.41|-8.61|
91707300|NCT04607980|183308413|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.14|||||TWO_SIDED|95.0|-7.32|7.43||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.43|-7.32|
91707301|NCT04607980|183308414|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.34|||||TWO_SIDED|95.0|-3.16|3.21||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||3.21|-3.16|
91707302|NCT04607980|183308414|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.58|||||TWO_SIDED|95.0|-5.03|8.18||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||8.18|-5.03|
91707303|NCT04607980|183308414|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.81|||||TWO_SIDED|95.0|-3.62|11.17||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||11.17|-3.62|
91707304|NCT04607980|183308414|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.07|||||TWO_SIDED|95.0|-4.68|10.78||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||10.78|-4.68|
91707305|NCT04607980|183308414|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-1.93|||||TWO_SIDED|95.0|-12.85|8.89||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||8.89|-12.85|
91707306|NCT04607980|183308414|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-4.93|||||TWO_SIDED|95.0|-17.39|7.73||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.73|-17.39|
91707307|NCT04607980|183308414|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-8.42|13.3||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||13.30|-8.42|
91707308|NCT04607980|183308414|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.41|||||TWO_SIDED|95.0|-14.91|10.19||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||10.19|-14.91|
91707309|NCT04607980|183308415|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-5.65|10.71||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||10.71|-5.65|
91707310|NCT04607980|183308415|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-6.57|||||TWO_SIDED|95.0|-15.41|3.29||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||3.29|-15.41|
91707311|NCT04607980|183308415|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-7.46|||||TWO_SIDED|95.0|-18.41|3.74||||||"Week 52: ABP 654/Ustekinumab vs Ustekinumab.~NRI was used."||3.74|-18.41|
91707312|NCT04607980|183308416|EQUIVALENCE|Mean difference estimated for treatment group A and treatment group B using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-1.15|2.1||||||"Week 12: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||2.10|-1.15|
91707313|NCT04607980|183308416|EQUIVALENCE|Mean difference estimated in dose intensification participants (treatment group A and treatment group B) using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.39|||||TWO_SIDED|95.0|-0.9|3.67||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||3.67|-0.90|
91707314|NCT04607980|183308416|EQUIVALENCE|Mean difference estimated for ABP 654/ ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.99|0.74||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.74|-0.99|
91707315|NCT04607980|183308416|EQUIVALENCE|Mean difference estimated for ustekinumab/ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.9|1.1||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.10|-0.90|
91707316|NCT03372382|183308433|EQUIVALENCE|We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it's 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-2.1|11.9|||||The upper boundary of the CI is out of pre-specified limits.|Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.||11.9|-2.1|
91707317|NCT01128400|183308481|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
91707318|NCT01128400|183308482|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
91707319|NCT05725824|183308490|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
91707320|NCT05725824|183308491|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
91707321|NCT05725824|183308492|SUPERIORITY||||||<|0.05||||||Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.|Repeated Measure Analysis of Variance|||||||<0.05
91707322|NCT05725824|183308493|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
91707323|NCT03782571|183308494|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|99.1|-4.0|7.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere clearance rate.||7.4|-4.0|
91645282|NCT00584831|183182085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645283|NCT00584831|183182085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645284|NCT00584831|183182085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645285|NCT00584831|183182086|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645286|NCT00584831|183182086|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645287|NCT00584831|183182086|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645288|NCT00584831|183182086|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645289|NCT00584831|183182086|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645290|NCT00584831|183182086|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
91645291|NCT01607398|183182087|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.05||||0.5146|TWO_SIDED|95.0|-20.5|7.6|||Wilcoxon (Mann-Whitney)|The analysis was done using the Van Elteren extension to the Wilcoxon rank sum test.|From Van-Elteren extension to the Wilcoxon Rank Sum test, adjusted for smoking status strata and Hodges-Lehmann estimator of the 95% CI, not stratified and unadjusted for multiplicity.|||7.600|-20.500|0.5146
91645292|NCT01211613|183182107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|14.0||0.009|TWO_SIDED|95.0||||The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.||||||0.009
91645293|NCT01211613|183182108|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.||||||0.002
91645294|NCT03853213|183182109|SUPERIORITY||Mean difference (in change score)|2.54||||0.698|TWO_SIDED|95.0|-11.62|16.71|||t-test, 2 sided|The p-value is adjusted using the Satterthwaite correction due to unequal variances between the two groups.|A higher value of the estimation parameter of mean difference in change score indicates a greater reduction in the measure for the intervention group relative to the attention control group.|||16.71|-11.62|0.698
91645295|NCT03853213|183182110|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.123|TWO_SIDED|95.0|-9.0|1.24|||t-test, 2 sided||A lower value of the estimation parameter of mean difference indicates lower extent of medication nonadherence for the intervention relative to the control group.|Note that the measure of extent of medication nonadherence used the older 5-item version of the scale rather than the newer 3-item version of the scale because the IRB modification to change the measure took effect after the majority of participants who provided data for Visit 2 had completed the measure.||1.24|-9.00|0.123
91645296|NCT03853213|183182111|SUPERIORITY||Mean difference (in change score)|66.29||||0.965|TWO_SIDED|95.0|-3081.7|3214.3|||t-test, 2 sided|||||3214.3|-3081.7|0.965
91645297|NCT03853213|183182112|SUPERIORITY||Mean difference (in change score)|-6.17||||0.29|TWO_SIDED|95.0|-18.15|5.81|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in context sensitivity for the intervention group relative to the attention control group.|||5.81|-18.15|0.290
91645298|NCT03853213|183182113|SUPERIORITY||Mean difference (in change score)|-5.07||||0.434|TWO_SIDED|95.0|-18.51|8.38|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in future time perspective for the intervention group relative to the attention control group.|||8.38|-18.51|0.434
91707324|NCT03782571|183308494|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|99.1|-4.0|13.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere clearance rate.||13.4|-4.0|
91645299|NCT03853213|183182114|SUPERIORITY||Mean Difference (Final Values)|17.05||||0.293|TWO_SIDED|95.0|-19.07|53.17|||t-test, 2 sided||A higher value of the estimation parameter of mean difference indicates a lower extent of objectively measured medication adherence for the intervention relative to the control group.|||53.17|-19.07|0.293
91645300|NCT00069160|183182117|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>.05
91645301|NCT02576054|183182146|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 6||1.57|1.00|<0.001
91707325|NCT03782571|183308494|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|99.1|-2.7|19.1|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere clearance rate.||19.1|-2.7|
91707326|NCT03782571|183308494|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|99.1|-2.6|15.5|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere clearance rate.||15.5|-2.6|
91707327|NCT03782571|183308494|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|99.1|-2.0|8.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere clearance rate.||8.9|-2.0|
91707328|NCT03782571|183308494|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|99.1|-4.3|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere clearance rate.||10.3|-4.3|
91707329|NCT03782571|183308495|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|3.24|||TWO_SIDED|99.1|-1.0|17.8|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere uptake rate.||17.8|-1.0|
91707330|NCT03782571|183308495|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.95|||TWO_SIDED|99.1|-7.8|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-7.8|
91707331|NCT03782571|183308495|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|99.1|-15.1|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-15.1|
91707332|NCT03782571|183308495|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|99.1|-20.4|9.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere uptake rate.||9.4|-20.4|
91707333|NCT03782571|183308495|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|99.1|-12.6|5.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere uptake rate.||5.3|-12.6|
91707334|NCT03782571|183308495|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|4.18|||TWO_SIDED|99.1|-13.9|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere uptake rate.||10.3|-13.9|
91707335|NCT01088711|183308518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.76|||||TWO_SIDED|90.0|82.7|99.37|||Difference in geometric means (GMs)|||||99.37|82.70|
91707336|NCT01088711|183308520|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|1.92|||||TWO_SIDED|90.0|1.55|2.38|||||GMR is ratio of active GLP-1 levels in omarigliptin:placebo groups.|||2.38|1.55|
91707337|NCT01088711|183308521|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|0.91|||||TWO_SIDED|90.0|0.72|1.17|||||GMR is ratio of total GLP-1 levels in omarigliptin:placebo groups.|||1.17|0.72|
91707338|NCT01240902|183308523|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|26.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|22.3|30.1|||z-test, 1 sided||Kaplan-Meier Event Rate Greenwood Standard Error|TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.||30.1|22.3|<0.0001
91707339|NCT01240902|183308523|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|39.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED||||||||Kaplan-Meier Event Rate Greenwood Standard Error|No performance goal created, only descriptive statistics are provided.||||
91707340|NCT01240902|183308523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.|||||<|0.0001|TWO_SIDED||||||z-test, 1 sided|||||||<0.0001
91707341|NCT01240902|183308524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1033|TWO_SIDED|||||Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.|Kaplan-Meier Point Estimate|Using Greenwood formula||"Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR \< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \>80%"||||0.1033
91707342|NCT01240902|183308528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.9|<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 2 sided|||Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
91707343|NCT01240902|183308528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline - NYHA1year.|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 1 sided|||"Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year."||||<0.0001
91707344|NCT01240902|183308531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #4|t-test, 2 sided|||Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
91707345|NCT01240902|183308531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 5||||||0.0063|TWO_SIDED|||||Hierarchical test item #4|t-test, 1 sided|||"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year."||||0.0063
91707346|NCT01240902|183308531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.|t-test, 2 sided|||"Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days."||||<0.0001
91707347|NCT01240902|183308532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 2 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
91707348|NCT01240902|183308532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 0.375|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 1 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2."||||<0.0001
91707349|NCT01240902|183308533|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 2 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
91707350|NCT01240902|183308533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 15|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 1 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg."||||<0.0001
91707351|NCT03543176|183308547|OTHER|||||||0.448||||||P-value for low impact of COPD is presented|Fisher Exact|||||||0.448
91707352|NCT03543176|183308547|OTHER|||||||0.033||||||P-value for medium impact of COPD is presented|Fisher Exact|||||||0.033
91707353|NCT03543176|183308547|OTHER|||||||0.172||||||P-value for high impact of COPD is presented|Fisher Exact|||||||0.172
91707354|NCT03543176|183308547|OTHER|||||||0.01||||||P-value for very high impact of COPD is presented|Fisher Exact|||||||0.010
91707355|NCT03543176|183308548|OTHER|||||||0.176||||||P-value for breathlessness reported in COPD assessed using mMRC is presented|Fisher Exact|||||||0.176
91707356|NCT03543176|183308549|OTHER|||||||0.732||||||P-value for Baseline comorbidity burden score was calculated.|t-test, 2 sided|||||||0.732
91707357|NCT03543176|183308550|OTHER|||||||0.013||||||P-value for count of unique medications was calculated.|t-test, 2 sided|||||||0.013
91771792|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2829|TWO_SIDED|95.0|0.35|35.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||35.22|0.35|0.2829
91771793|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|2.12||||0.5311|TWO_SIDED|95.0|0.2|22.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||22.29|0.20|0.5311
91771794|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1857|TWO_SIDED|95.0|0.47|46.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.83|0.47|0.1857
91707358|NCT03543176|183308551|OTHER|||||||0.178||||||P-value for total number of medications dispensing was calculated.|t-test, 2 sided|||||||0.178
91707359|NCT03543176|183308557|OTHER|||||||0.692||||||P-value for count of unique COPD medications was calculated|t-test, 2 sided|||||||0.692
91707360|NCT03543176|183308558|OTHER||||||<|0.001||||||P-value for total number of COPD medications dispensing was calculated|t-test, 2 sided|||||||<0.001
91707361|NCT01267929|183308566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.14||0.34|TWO_SIDED|95.0|-2.3|6.5||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the second month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.||6.5|-2.3|0.34
91707362|NCT01267929|183308566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-6.3|4.7||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the sixth month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.||4.7|-6.3|0.78
91707363|NCT03441685|183308576|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.73||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.73
91707364|NCT03441685|183308576|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.69||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.69
91707365|NCT03441685|183308576|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
91707366|NCT03441685|183308576|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.002||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.002
91707367|NCT03441685|183308576|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.049||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.049
91707368|NCT03441685|183308576|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.016||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.016
91707369|NCT03441685|183308577|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.76||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.76
91707370|NCT03441685|183308577|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
91707371|NCT03441685|183308577|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||1.00
91707372|NCT03441685|183308577|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.003||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.003
91707373|NCT03441685|183308577|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.029||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.029
91707374|NCT03441685|183308577|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
91707375|NCT03441685|183308578|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.72||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.72
91707376|NCT03441685|183308578|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.46||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.46
91707377|NCT03441685|183308578|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.89||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.89
91707378|NCT03441685|183308578|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
91707379|NCT03441685|183308578|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.018||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.018
91707380|NCT03441685|183308578|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
91707381|NCT03441685|183308579|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.64||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.64
91707382|NCT03441685|183308579|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.16||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.16
91707383|NCT03441685|183308579|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
91707384|NCT03441685|183308579|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
91707385|NCT03441685|183308579|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.034||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.034
91707386|NCT03441685|183308579|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.063||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.063
91707387|NCT03441685|183308580|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.35||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.35
91707388|NCT03441685|183308580|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
91707389|NCT03441685|183308580|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.58|||||||Wilcoxon Signed Ranks Test|||||||0.58
91707390|NCT03441685|183308580|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.006||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.006
91707391|NCT03441685|183308580|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.02||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.02
91707392|NCT03441685|183308580|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.18||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.18
91707393|NCT03441685|183308581|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.56||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.56
91645302|NCT02576054|183182146|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.89|2.78|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio = GMT PN200 divided by GMT PN122|Anti-HPV 11||2.78|1.89|<0.001
91707394|NCT03441685|183308581|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.10
91707395|NCT03441685|183308581|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.71||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.71
91707396|NCT03441685|183308581|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
91707397|NCT03441685|183308581|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.024||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.024
91707398|NCT03441685|183308581|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.1||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.10
91707399|NCT01796301|183308582|SUPERIORITY|A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below.|Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.7|3.8|||Linear mixed effects repeated measures|||The primary analysis to assess the treatment difference (Romosozumab - Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.||3.8|2.7|< 0.0001
91707400|NCT01796301|183308583|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.7|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.7|2.5|< 0.0001
91707401|NCT01796301|183308584|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
91707402|NCT01796301|183308585|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
91707403|NCT01796301|183308586|SUPERIORITY||Treatment difference|4.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|3.9|5.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||5.3|3.9|< 0.0001
91707404|NCT01796301|183308587|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.5|< 0.0001
91707405|NCT01796301|183308588|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
91707406|NCT01796301|183308589|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.4|3.8|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.8|2.4|< 0.0001
91707407|NCT01796301|183308590|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|2.1|4.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.3|2.1|< 0.0001
91707408|NCT01796301|183308591|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.6|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.6|< 0.0001
91710568|NCT02634983|183313761|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.0821|TWO_SIDED|90.0|0.04|1.27|||t-test, 2 sided|||Diffusion Capacity of Lung for CO||1.27|0.04|0.0821
91707409|NCT01796301|183308592|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
91707410|NCT01796301|183308593|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.5|3.9|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.9|2.5|< 0.0001
91707411|NCT01796301|183308594|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.6|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.2|2.6|< 0.0001
91707412|NCT01796301|183308595|SUPERIORITY||Treatment difference|3.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.6|2.9|< 0.0001
91707413|NCT01796301|183308596|SUPERIORITY||Treatment difference|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|3.4|5.4|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||5.4|3.4|< 0.0001
91707414|NCT01884545|183308612|SUPERIORITY|||||||0.1073|||||||Regression, Linear|||||||0.1073
91707415|NCT01884545|183308612|SUPERIORITY|||||||0.0615|||||||Regression, Linear|||||||0.0615
91707416|NCT01884545|183308613|SUPERIORITY|||||||0.6732|||||||Regression, Linear|||||||0.6732
91707417|NCT01884545|183308613|SUPERIORITY|||||||0.3754|||||||Regression, Linear|||||||0.3754
91519747|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.01
91707418|NCT01884545|183308614|SUPERIORITY||Odds Ratio (OR)|2.853||||0.0073|TWO_SIDED|95.0|1.326|6.139|||Regression, Logistic|||||6.139|1.326|0.0073
91707419|NCT01884545|183308614|SUPERIORITY||Odds Ratio (OR)|1.045||||0.9068|TWO_SIDED|95.0|0.5|2.183|||Regression, Logistic|||||2.183|0.5|0.9068
91707420|NCT01884545|183308615|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
91707421|NCT01884545|183308615|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
91707422|NCT01884545|183308616|SUPERIORITY|||||||0.7985|||||||Regression, Linear|||||||0.7985
91707423|NCT01884545|183308616|SUPERIORITY|||||||0.1642|||||||Regression, Linear|||||||0.1642
91707424|NCT01884545|183308617|SUPERIORITY|||||||0.8027|||||||Regression, Linear|||||||0.8027
91707425|NCT01884545|183308617|SUPERIORITY|||||||0.7751|||||||Regression, Linear|||||||0.7751
91707426|NCT01884545|183308618|SUPERIORITY|||||||0.5557|||||||Regression, Linear|||||||0.5557
91707427|NCT01884545|183308618|SUPERIORITY|||||||0.7834|||||||Regression, Linear|||||||0.7834
91707428|NCT01884545|183308619|SUPERIORITY|||||||0.1439|||||||Regression, Linear|||||||0.1439
91707429|NCT01884545|183308619|SUPERIORITY|||||||0.2275|||||||Regression, Linear|||||||0.2275
91707430|NCT01884545|183308620|SUPERIORITY|||||||0.7639|||||||Regression, Linear|||||||0.7639
91707431|NCT01884545|183308620|SUPERIORITY|||||||0.9999|||||||Regression, Linear|||||||0.9999
91707432|NCT01884545|183308621|SUPERIORITY|||||||0.4673|||||||Regression, Linear|||||||0.4673
91707433|NCT01884545|183308621|SUPERIORITY|||||||0.2297|||||||Regression, Linear|||||||0.2297
91707434|NCT01884545|183308622|SUPERIORITY|||||||0.2192|||||||Regression, Linear|||||||0.2192
91707435|NCT01884545|183308622|SUPERIORITY|||||||0.9062|||||||Regression, Linear|||||||0.9062
91707436|NCT01884545|183308623|SUPERIORITY|||||||0.1466|||||||Regression, Linear|||||||0.1466
91707437|NCT01884545|183308623|SUPERIORITY|||||||0.207|||||||Regression, Linear|||||||0.2070
91707438|NCT01884545|183308624|SUPERIORITY|||||||0.6289|||||||Regression, Linear|||||||0.6289
91707439|NCT01884545|183308624|SUPERIORITY|||||||0.9631|||||||Regression, Linear|||||||0.9631
91707440|NCT01884545|183308625|SUPERIORITY|||||||0.2313|||||||Regression, Linear|||||||0.2313
91707441|NCT01884545|183308625|SUPERIORITY|||||||0.8029|||||||Regression, Linear|||||||0.8029
91707442|NCT01884545|183308626|SUPERIORITY|||||||0.071|||||||Regression, Linear|||||||0.0710
91707443|NCT01884545|183308626|SUPERIORITY|||||||0.8069|||||||Regression, Linear|||||||0.8069
91707444|NCT01884545|183308627|SUPERIORITY|||||||0.0512|||||||Chi-squared|||||||0.0512
91707445|NCT01884545|183308627|SUPERIORITY|||||||0.4478|||||||Chi-squared|||||||0.4478
91707446|NCT01884545|183308630|SUPERIORITY|||||||0.7923|||||||Regression, Linear|||Perceived Risk for CHD, Consequences subscale||||0.7923
91707447|NCT01884545|183308630|SUPERIORITY|||||||0.0636|||||||Regression, Linear|||Perceived Risk for CHD, Personal control||||0.0636
91707448|NCT01884545|183308630|SUPERIORITY|||||||0.2063|||||||Regression, Linear|||Perceived Risk for CHD, Treatment control||||0.2063
91707449|NCT01884545|183308630|SUPERIORITY|||||||0.2529|||||||Regression, Linear|||Perceived Risk for CHD, Emotional representations||||0.2529
91707450|NCT01884545|183308630|SUPERIORITY|||||||0.1085|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), Consequences subscale||||0.1085
91707451|NCT01884545|183308630|SUPERIORITY|||||||0.337|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), personal control subscale||||0.3370
91707452|NCT01884545|183308630|SUPERIORITY|||||||0.3483|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), treatment control subscale||||0.3483
91707453|NCT01884545|183308630|SUPERIORITY|||||||0.5384|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), emotional representations||||0.5384
91707454|NCT01884545|183308631|SUPERIORITY|||||||0.7447|||||||Regression, Linear|||Perceived Risk for T2D, Consequences subscale||||0.7447
91707455|NCT01884545|183308631|SUPERIORITY|||||||0.6378|||||||Regression, Linear|||Perceived Risk for T2D, Personal control||||0.6378
91707456|NCT01884545|183308631|SUPERIORITY|||||||0.3209|||||||Regression, Linear|||Perceived Risk for T2D, Treatment control||||0.3209
91707457|NCT01884545|183308631|SUPERIORITY|||||||0.0058|||||||Regression, Linear|||Perceived Risk for T2D, Emotional representations||||0.0058
91645303|NCT02576054|183182146|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.69|||<|0.001|TWO_SIDED|95.0|1.35|2.11|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 16||2.11|1.35|<0.001
91645304|NCT02576054|183182146|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|3.05|||<|0.001|TWO_SIDED|95.0|2.33|3.99|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 18||3.99|2.33|<0.001
91645305|NCT01818414|183182182|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91645306|NCT01818414|183182183|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
91645307|NCT00450177|183182196|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
91707458|NCT01884545|183308631|SUPERIORITY|||||||0.3769|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), Consequences subscale||||0.3769
91707459|NCT01884545|183308631|SUPERIORITY|||||||0.0872|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), personal control||||0.0872
91707460|NCT01884545|183308631|SUPERIORITY|||||||0.4302|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), treatment control||||0.4302
91707461|NCT01884545|183308631|SUPERIORITY|||||||0.4133|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), emotional representations||||0.4133
91707462|NCT01884545|183308632|SUPERIORITY|||||||0.3106|||||||Regression, Linear|||||||0.3106
91707463|NCT01884545|183308632|SUPERIORITY|||||||0.7087|||||||Regression, Linear|||||||0.7087
91707464|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|1.034||||0.9259|TWO_SIDED|95.0|0.511|2.094|||Regression, Logistic|||Stages of Change, Weight reduction||2.094|0.511|0.9259
91645308|NCT01227954|183182235|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||To detect a minimum relative 50% improvement leading to an absolute 15% mean relative decline (MRD) in HVLT-R DR, 51 analyzable patients were required to ensure 80% statistical power with 0.05 alpha. Assuming a death rate of 40% before 4 months (based on trial NCT00003563) and a 10% nonevaluable rate, the target sample size was 102. The target MRD was determined from NCT00003563 which demonstrated 30% MRD in HVLT-R DR score from baseline to 4 months, with a standard deviation of 41%.||||<0.001
91707465|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|2.252||||0.0082|TWO_SIDED|95.0|1.234|4.111|||Regression, Logistic|||Stages of Change, Exercise behavior||4.111|1.234|0.0082
91707466|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|0.423||||0.2954|TWO_SIDED|95.0|0.084|2.12|||Regression, Logistic|||Stages of Change, Smoking behavior||2.120|0.084|0.2954
91707467|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|1.216||||0.5669|TWO_SIDED|95.0|0.622|2.376|||Regression, Logistic|||Stages of Change, Healthier eating behavior||2.376|0.622|0.5669
91707468|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|0.622||||0.121|TWO_SIDED|95.0|0.341|1.134|||Regression, Logistic|||Stages of Change, Stress behavior||1.134|0.341|0.1210
91707469|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|0.928||||0.8355|TWO_SIDED|95.0|0.461|1.872|||Regression, Logistic|||Weight reduction||1.872|0.461|0.8355
91707470|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0459|TWO_SIDED|95.0|1.011|3.311|||Regression, Logistic|||Exercise behavior||3.311|1.011|0.0459
91707471|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|0.563||||0.465|TWO_SIDED|95.0|0.121|2.629|||Regression, Logistic|||Smoking behavior||2.629|0.121|0.4650
91707472|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8303|TWO_SIDED|95.0|0.478|1.808|||Regression, Logistic|||Healthier eating behavior||1.808|0.478|0.8303
91707473|NCT01884545|183308633|SUPERIORITY||Odds Ratio (OR)|1.347||||0.3254|TWO_SIDED|95.0|0.744|2.439|||Regression, Logistic|||Stress behavior||2.439|0.744|0.3254
91707474|NCT01884545|183308634|SUPERIORITY|||||||0.0174|||||||Regression, Linear|||||||0.0174
91707475|NCT01884545|183308634|SUPERIORITY|||||||0.8694|||||||Regression, Linear|||||||0.8694
91707476|NCT01884545|183308635|SUPERIORITY|||||||0.4768|||||||Regression, Linear|||||||0.4768
91707477|NCT01884545|183308635|SUPERIORITY|||||||0.8452|||||||Regression, Linear|||||||0.8452
91707478|NCT01884545|183308636|SUPERIORITY||Odds Ratio (OR)|1.591||||0.5589|TWO_SIDED|95.0|0.335|7.544|||Regression, Logistic|||||7.544|0.335|0.5589
91707479|NCT01410240|183308637|SUPERIORITY_OR_OTHER|||||||0.453|||||||one-sided, two-sample t-test|||||||0.453
91707480|NCT01410240|183308638|SUPERIORITY_OR_OTHER|||||||0.708|||||||one-sided, two-sample t-test|||||||0.708
91707481|NCT01410240|183308639|SUPERIORITY_OR_OTHER|||||||0.527|||||||one-sided, two-sample t-test|||||||0.527
91707482|NCT01410240|183308640|SUPERIORITY_OR_OTHER|||||||0.561|||||||one-sided Wilcoxon rank sum test|||||||0.561
91707483|NCT01410240|183308641|SUPERIORITY_OR_OTHER|||||||0.356|||||||one-sided Wilcoxon rank sum test|||||||0.356
91707484|NCT01410240|183308642|SUPERIORITY_OR_OTHER|||||||0.533|||||||one-sided Wilcoxon rank sum test|||||||0.533
91707485|NCT01410240|183308643|SUPERIORITY_OR_OTHER|||||||0.734|||||||two-sided Wilcoxon rank sum test|||||||0.734
91707486|NCT01410240|183308646|SUPERIORITY_OR_OTHER|||||||0.314|||||||two-sided Wilcoxon rank sum test|||||||0.314
91707487|NCT01410240|183308647|SUPERIORITY_OR_OTHER|||||||0.063|||||||two-sided Wilcoxon rank sum test|||||||0.063
91707488|NCT01410240|183308650|SUPERIORITY_OR_OTHER|||||||0.058|||||||two-sided Wilcoxon rank sum test|||||||0.058
91645309|NCT01227954|183182238|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and recursive partitioning analysis class (RPA) (I vs. II). Explanatory variables are reported separately and only if in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
91645310|NCT01227954|183182238|SUPERIORITY|||||||0.1961|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1961
91645311|NCT01227954|183182238|SUPERIORITY|||||||0.0715|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Primary site (lung) is reported here.||||0.0715
91645312|NCT01227954|183182238|SUPERIORITY|||||||0.0554|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic status (no symptoms) is reported here.||||0.0554
91645313|NCT01227954|183182239|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
91645314|NCT01227954|183182239|SUPERIORITY|||||||0.1579|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1579
91645315|NCT01227954|183182239|SUPERIORITY|||||||0.0559|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic function status (some symptoms) is reported here.||||0.0559
91645316|NCT01227954|183182239|SUPERIORITY|||||||0.0749|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Age (\>= 60) is reported here.||||0.0749
91645317|NCT04256759|183182270|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Week 12||||0.018
91645318|NCT04256759|183182270|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Week 18||||0.021
91645319|NCT04256759|183182271|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91645320|NCT04256759|183182272|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91645321|NCT03901352|183182283|SUPERIORITY||Difference of LSM vs placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.187||0.0001|TWO_SIDED|95.0|-1.08|-0.34|||ANCOVA||"The multiple imputation (MI) was based on a nonfuture dependence model using the pattern mixture model (PMM) approach with shifting parameters under the missing not at random (MNAR0 mechanism for the missing weekly ADPS."|||-0.34|-1.08|0.0001
91645322|NCT02742818|183182346|OTHER|||||||0.19|||||||Generalized Estimation Equations (GEE)|Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.|||Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.|||0.190
91645323|NCT02742818|183182347|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
91645324|NCT02742818|183182348|OTHER|||||||0.529|||||||Chi-squared|||||||0.529
91645325|NCT02742818|183182349|OTHER|||||||0.999|||||||Chi-squared|||||||0.999
91645326|NCT02742818|183182350|OTHER|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
91645327|NCT03889197|183182379|SUPERIORITY|||||||0.162|||||||Kruskal-Wallis|||||||0.162
91645328|NCT03889197|183182380|SUPERIORITY|||||||0.242|||||||Kruskal-Wallis|||||||0.242
91645329|NCT03889197|183182381|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
91645330|NCT03889197|183182382|SUPERIORITY|||||||0.132|||||||Kruskal-Wallis|||||||0.132
91645331|NCT03889197|183182383|SUPERIORITY|||||||0.445|||||||Kruskal-Wallis|||||||0.445
91707489|NCT01410240|183308651|SUPERIORITY_OR_OTHER|||||||0.421|||||||two-sided Wilcoxon rank sum test|||||||0.421
91519748|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.02|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.02
91645332|NCT03889197|183182384|SUPERIORITY|||||||0.746|||||||Kruskal-Wallis|||||||0.746
91645333|NCT03889197|183182385|SUPERIORITY|||||||0.979|||||||Kruskal-Wallis|||||||0.979
91645334|NCT03889197|183182386|SUPERIORITY|||||||0.289|||||||Chi-squared|||||||0.289
91645335|NCT03889197|183182387|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||0.940
91645336|NCT03889197|183182388|SUPERIORITY|||||||0.126|||||||Chi-squared|||||||0.126
91645337|NCT03889197|183182389|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
91645338|NCT03889197|183182390|SUPERIORITY|||||||0.676|||||||Fisher Exact|||||||0.676
91645339|NCT03889197|183182391|SUPERIORITY|||||||0.996|||||||Kruskal-Wallis|||||||0.996
91645340|NCT03889197|183182392|SUPERIORITY|||||||0.095|||||||Kruskal-Wallis|||||||0.095
91645341|NCT03193190|183182408|SUPERIORITY||Difference in ORR|18.06|||||TWO_SIDED|95.0|-25.6|61.71||||||||61.71|-25.60|
91645342|NCT03193190|183182408|SUPERIORITY||Difference in ORR|10.5|||||TWO_SIDED|95.0|-18.85|39.85||||||||39.85|-18.85|
91645343|NCT03193190|183182408|SUPERIORITY||Difference in ORR|-10.83|||||TWO_SIDED|95.0|-43.7|22.03||||||||22.03|-43.70|
91645344|NCT03193190|183182408|SUPERIORITY||Difference in Overall Response Rates|-5.79|||||TWO_SIDED|95.0|-30.58|18.99||||||||18.99|-30.58|
91645345|NCT03193190|183182408|SUPERIORITY||Difference in ORR|-7.5|||||TWO_SIDED|95.0|-34.19|19.19||||||||19.19|-34.19|
91645346|NCT03193190|183182408|SUPERIORITY||Difference in ORR|-8.7|||||TWO_SIDED|95.0|-25.96|8.57||||||||8.57|-25.96|
91645347|NCT03193190|183182408|SUPERIORITY||Difference in Overall Response Rates|-8.7|||||TWO_SIDED|95.0|-25.96|8.57||||||||8.57|-25.96|
91645348|NCT03193190|183182408|SUPERIORITY||Difference in ORR|-2.64|||||TWO_SIDED|95.0|-18.44|13.17||||||||13.17|-18.44|
91645349|NCT03193190|183182408|SUPERIORITY||Difference in ORR|-8.7|||||TWO_SIDED|95.0|-25.72|8.33||||||||8.33|-25.72|
91645350|NCT03193190|183182408|SUPERIORITY||Difference in ORR|-1.55|||||TWO_SIDED|95.0|-25.04|21.93||||||||21.93|-25.04|
91645351|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.48|2.64||||||||2.64|0.48|
91645352|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.66|2.08||||||||2.08|0.66|
91645353|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.29|1.23||||||||1.23|0.29|
91645354|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.67|1.89||||||||1.89|0.67|
91645355|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.61|1.87||||||||1.87|0.61|
91645356|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|2.13|||||TWO_SIDED|95.0|0.96|4.75||||||||4.75|0.96|
91645357|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|3.63|||||TWO_SIDED|95.0|1.54|8.57||||||||8.57|1.54|
91645358|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.68|1.92||||||||1.92|0.68|
91645359|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|0.72|3.05||||||||3.05|0.72|
91645360|NCT03193190|183182410|SUPERIORITY||Hazard Ratio (HR)|1.74|||||TWO_SIDED|95.0|0.84|3.06||||||||3.06|0.84|
91645361|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.59|3.0||||||||3.00|0.59|
91645362|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.71|2.29||||||||2.29|0.71|
91645363|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.45|1.74||||||||1.74|0.45|
91645364|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.58|1.68||||||||1.68|0.58|
91645365|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.59|1.84||||||||1.84|0.59|
91645366|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|2.04|||||TWO_SIDED|95.0|0.87|4.77||||||||4.77|0.87|
91645367|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.6|2.94||||||||2.94|0.60|
91645368|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.48|1.6||||||||1.60|0.48|
91645369|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|1.51|||||TWO_SIDED|95.0|0.68|3.36||||||||3.36|0.68|
91645370|NCT03193190|183182411|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.44|2.02||||||||2.02|0.44|
91707490|NCT01410240|183308652|SUPERIORITY_OR_OTHER|||||||0.161|||||||two-sided Wilcoxon rank sum test|||||||0.161
91645371|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-31.51|||||TWO_SIDED|95.0|-66.07|3.04||||||||3.04|-66.07|
91645372|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-3.59|||||TWO_SIDED|95.0|-22.55|15.37||||||||15.37|-22.55|
91645373|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-7.07|||||TWO_SIDED|95.0|-30.52|16.38||||||||16.38|-30.52|
91645374|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-14.52|||||TWO_SIDED|95.0|-32.72|3.68||||||||3.68|-32.72|
91645375|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-0.4|||||TWO_SIDED|95.0|-17.38|16.57||||||||16.57|-17.38|
91645376|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-50.98|||||TWO_SIDED|95.0|-83.51|-18.46||||||||-18.46|-83.51|
91645377|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-36.8|||||TWO_SIDED|95.0|-70.43|-3.18||||||||-3.18|-70.43|
91645378|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-26.79|||||TWO_SIDED|95.0|-49.39|-4.2||||||||-4.20|-49.39|
91645379|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-35.43|||||TWO_SIDED|95.0|-67.44|-3.42||||||||-3.42|-67.44|
91645380|NCT03193190|183182412|SUPERIORITY||Difference in Event Free Rate|-28.76|||||TWO_SIDED|95.0|-60.94|3.42||||||||3.42|-60.94|
91645381|NCT03193190|183182413|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.24|3.51||||||||3.51|0.24|
91707491|NCT01410240|183308653|SUPERIORITY_OR_OTHER|||||||0.016|||||||two-sided Wilcoxon rank sum test|||||||0.016
91707492|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.534|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Pain||||0.534
91707493|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.269|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Stiffness||||0.269
91707494|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.693|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Physical Functioning||||0.693
91707495|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Average Score||||0.343
91707496|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Total Score||||0.343
91707497|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.978|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Pain||||0.978
91707498|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.709|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Stiffness||||0.709
91707499|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.594|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.594
91707500|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Average Score||||0.501
91707501|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Total Score||||0.501
91707502|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.171|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Pain||||0.171
91645382|NCT03193190|183182413|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.23|1.6||||||||1.60|0.23|
91707503|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.077|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Stiffness||||0.077
91707504|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.026|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.026
91707505|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Average Score||||0.012
91707506|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Total Score||||0.012
91707507|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.126|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Pain||||0.126
91707508|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.044|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Stiffness||||0.044
91707509|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.153||||||Change Week 6: Physical Functioning|two-sided Wilcoxon rank sum test|||||||0.153
91707510|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Average Score||||0.134
91707511|NCT01410240|183308655|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Total Score||||0.134
91707512|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.962|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.962
91645383|NCT03193190|183182413|SUPERIORITY||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.44|5.47||||||||5.47|0.44|
91645384|NCT03193190|183182413|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.35|2.44||||||||2.44|0.35|
91645385|NCT03193190|183182413|SUPERIORITY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.24|1.93||||||||1.93|0.24|
91707513|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.714|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Physical||||0.714
91707514|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.668|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Bodily Pain||||0.668
91707515|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.556|||||||two-sided Wilcoxon rank sum test|||Change Week 1: General Health||||0.556
91707516|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.705|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Vitality||||0.705
91707517|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.122|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Social Functioning||||0.122
91707518|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.254|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Emotional||||0.254
91707519|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.5|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Mental Health||||0.500
91707520|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.849|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Component Summary||||0.849
91707521|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||Change Week 1: Mental Component Summary||||0.959
91707522|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.574|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.574
91707523|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.524|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Physical||||0.524
91707524|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.049|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Bodily Pain||||0.049
91707525|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.447|||||||two-sided Wilcoxon rank sum test|||Change Week 2: General Health||||0.447
91707526|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.823|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Vitality||||0.823
91707527|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.661|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Social Functioning||||0.661
91707528|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.086|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Emotional||||0.086
91707529|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.635|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Health||||0.635
91707530|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.481|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Component Summary||||0.481
91707531|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.14|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Component Summary||||0.140
91707532|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.107|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Functioning||||0.107
91707533|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.298|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Physical||||0.298
91707534|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.071|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Bodily Pain||||0.071
91707535|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.94|||||||two-sided Wilcoxon rank sum test|||Change Week 6: General Health||||0.940
91707536|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.293|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Vitality||||0.293
91707537|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.265|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Social Functioning||||0.265
91707538|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Emotional||||0.036
91707539|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.307|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Health||||0.307
91707540|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.448|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Component Summary||||0.448
91707541|NCT01410240|183308657|SUPERIORITY_OR_OTHER|||||||0.255|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Component Summary||||0.255
91707542|NCT01410240|183308659|SUPERIORITY_OR_OTHER|||||||0.052|||||||two-sided Wilcoxon rank sum test|||||||0.052
91707543|NCT03244618|183308742|SUPERIORITY||Mean Difference (Final Values)|-0.544|||<|0.001|TWO_SIDED|95.0|-0.712|-0.377|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.|||-0.377|-0.712|<0.001
91707544|NCT03244618|183308743|SUPERIORITY||Mean Difference (Final Values)|10.8|||<|0.001|TWO_SIDED|95.0|7.5|14.0|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.|||14.0|7.5|<0.001
91707545|NCT03244618|183308744|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.001|TWO_SIDED|95.0|-16.4|-5.5|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.5|-16.4|<0.001
91707546|NCT03244618|183308745|SUPERIORITY||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.85|-0.489|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.|||-0.489|-0.850|<0.001
91707547|NCT03244618|183308746|SUPERIORITY||Mean Difference (Final Values)|11.9|||<|0.001|TWO_SIDED|95.0|8.6|15.1|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste|||15.1|8.6|<0.001
91645386|NCT05004181|183182444|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the GMR was greater than 0.67.|Geometric mean ratio|13.12|||||TWO_SIDED|95.0|11.14|15.45|||||GMRs and 2-sided 95% CIs were based on the analysis of logarithmically transformed neutralizing titers using a linear regression model with terms of age, sex, and group.|||15.45|11.14|
91707548|NCT03244618|183308747|SUPERIORITY||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-16.6|-5.2|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.2|-16.6|<0.001
91707549|NCT01215435|183308764|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.|Estimated treatment difference, Mean|-0.14|||<|0.001||95.0|-0.4|0.13|||Regression, Linear|||H0: D \> 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)||0.13|-0.40|<0.001
91707550|NCT01215435|183308765|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-3.14||||0.6215||95.0|-15.65|9.37|||Regression, Linear|||||9.37|-15.65|0.6215
91707551|NCT00435019|183308852|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.|Mean Difference (Final Values)|0.12||||||95.0|-0.12|0.36|||ANCOVA|||||0.36|-0.12|
91707552|NCT01180049|183308885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731|||||TWO_SIDED|80.0|0.52|1.027||||||||1.027|0.520|
91707553|NCT01180049|183308886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778|||||TWO_SIDED|80.0|0.568|1.064||||||||1.064|0.568|
91707554|NCT01180049|183308887|SUPERIORITY_OR_OTHER||Difference in arms|6.7|||||TWO_SIDED|80.0|-6.9|20.3||||||Independent assessment- Difference (%) TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||20.3|-6.9|
91707555|NCT01180049|183308888|SUPERIORITY_OR_OTHER||Difference between arms|13.3|||||TWO_SIDED|80.0|-0.4|26.7||||||Investigator's assessment- Difference (%)TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||26.7|-0.4|
91707556|NCT01180049|183308889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||||TWO_SIDED|80.0|0.453|0.922||||||||0.922|0.453|
91771795|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9879|TWO_SIDED|95.0|0.06|17.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.50|0.06|0.9879
91707557|NCT04227405|183308938|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||>.05
91707558|NCT04227405|183308938|SUPERIORITY||Slope|1.59|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||<.001
91707559|NCT04227405|183308938|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Positive Conflict Management subscale||||<.001
91707560|NCT04227405|183308938|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Negative Conflict Management for the Control Group||||>.05
91707561|NCT04227405|183308938|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.29|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the Negative Conflict Management subscale||||<.01
91707562|NCT04227405|183308938|SUPERIORITY||Slope|-1.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Negative Conflict Management subscale||||<.01
91707563|NCT04227405|183308938|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes in the Relationship Quality subscale from Pre-test to post-test in the control group||||<.05
91707564|NCT04227405|183308938|SUPERIORITY||Slope|0.86|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes in the Relationship Quality Subscale from pretest to posttest in the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
91707565|NCT04227405|183308938|SUPERIORITY||Slope|0.53|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Qualitty subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
91707566|NCT04227405|183308938|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.05
91707567|NCT04227405|183308938|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Emotional Abuse subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
91707568|NCT04227405|183308938|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Emotional Abuse subscale|The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
91645387|NCT05004181|183182445|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the difference of percentages was greater than -10%.|Difference in Percentages|-4.55|||||TWO_SIDED|95.0|-10.04|0.83|||||Adjusted difference in percentages were estimated using minimum risk weights and stratified by sex and age group.|||0.83|-10.04|
91707569|NCT04227405|183308938|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Relationship Satisfaction subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
91707570|NCT04227405|183308938|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Changes from pre-test to posttest in the Relationship satisfaction subscale for the intervention group||||<.001
91707571|NCT04227405|183308938|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Satisfactionn subscale||||<.001
91645388|NCT05004181|183182447|OTHER||Difference in Percentages|36.73|||||TWO_SIDED|95.0|19.21|51.17|||||Adjusted difference was estimated using the minimum risk weights and stratified by sex and age group.|||51.17|19.21|
91707572|NCT04227405|183308938|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the control group||||>.05
91707573|NCT04227405|183308938|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the intervention group||||<.001
91707574|NCT04227405|183308938|SUPERIORITY||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Commitment subscale||||<.001
91707575|NCT04227405|183308938|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Depression subscale for the control group||||<.001
91707576|NCT04227405|183308938|SUPERIORITY||Slope|-0.81|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Changes from pre-test to posttest in the Depression subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
91707577|NCT04227405|183308938|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Depression subscale||||>.05
91707578|NCT04227405|183308938|SUPERIORITY||Slope|-0.26|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the control group||||>.05
91707579|NCT04227405|183308938|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the intervention group||||<.001
91707580|NCT04227405|183308938|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test and post-test in the intervention group were not significantly different from the change from pre-test and post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Anxiety subscale||||>.05
91707581|NCT04227405|183308938|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Budgeting subscale for the control group||||<.05
91707582|NCT04227405|183308938|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Budgeting subscale for the intervention group||||<.001
91707583|NCT04227405|183308938|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Budgeting subscale||||<.10
91707584|NCT04227405|183308938|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the control group||||<.10
91707585|NCT04227405|183308938|SUPERIORITY||Slope|-0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the intervention group||||<.001
91707586|NCT04227405|183308938|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Difficulties to Pay Bills subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
91707587|NCT04227405|183308938|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the control group||||>.05
91707588|NCT04227405|183308938|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the intervention group||||<.05
91645389|NCT02239692|183182529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-3.93|||<|0.0001|TWO_SIDED|95.0|-4.99|-2.87||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-2.87|-4.99|<0.0001
91645390|NCT02239692|183182530|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-4.38|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.41||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-3.41|-5.34|<0.0001
91645391|NCT02239692|183182531|SUPERIORITY_OR_OTHER||Adjusted estimated odds ratio|9.18|||<|0.0001|TWO_SIDED|95.0|4.36|19.32||p-value corresponds to a two-sided test of superiority.|Regression, Logistic|Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.|The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||19.32|4.36|<0.0001
91645392|NCT02007369|183182538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.033|TWO_SIDED|95.0|0.05|0.89|||Regression, Logistic|||||0.89|0.05|0.033
91645393|NCT02007369|183182538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.934|TWO_SIDED|95.0|0.36|3.01|||Regression, Logistic|||||3.01|0.36|0.934
91645394|NCT02007369|183182539|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
91645395|NCT02007369|183182539|SUPERIORITY_OR_OTHER|||||||0.199|||||||Fisher Exact|||||||0.199
91645396|NCT02007369|183182540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.285|TWO_SIDED|95.0|0.25|1.5|||Regression, Logistic|||||1.50|0.25|0.285
91645397|NCT02007369|183182540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.597|TWO_SIDED|95.0|0.31|1.97|||Regression, Logistic|||||1.97|0.31|0.597
91645398|NCT02007369|183182541|SUPERIORITY_OR_OTHER|||||||0.023|||||||Fisher Exact|||||||0.023
91645399|NCT02007369|183182541|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||||||0.527
91645400|NCT01901146|183182542|EQUIVALENCE|The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).|Risk Difference (RD)|7.3||||0.0508|TWO_SIDED|90.0|1.2|13.4|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.4|1.2|0.0508
91645401|NCT01901146|183182542|EQUIVALENCE|If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.|Risk Ratio (RR)|1.1877||||0.043|TWO_SIDED|90.0|1.0327|1.366|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3660|1.0327|0.0430
91645402|NCT01901146|183182543|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|6.0||||0.1086|TWO_SIDED|90.0|-0.2|12.2|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||12.2|-0.2|0.1086
91645403|NCT01901146|183182543|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.1463||||0.0807|TWO_SIDED|90.0|1.008|1.3035|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3035|1.0080|0.0807
91645404|NCT01901146|183182544|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|8.0||||0.0253|TWO_SIDED|90.0|2.1|13.9|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.9|2.1|0.0253
91645405|NCT01901146|183182544|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.2746||||0.0245|TWO_SIDED|90.0|1.0673|1.5222|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.5222|1.0673|0.0245
91707589|NCT04227405|183308938|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to pos-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time with Partner subscale||||>.05
91707590|NCT04227405|183308938|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Positive values indicate an increase whereas a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for control group||||>.05
91707591|NCT04227405|183308938|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for the intervention group||||>.05
91707592|NCT04227405|183308938|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in Banking subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|||>.05
91707593|NCT04227405|183308938|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the control group||||>.05
91707594|NCT04227405|183308938|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the intervention group||||>.05
91707595|NCT04227405|183308938|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Parenting stresss subscale||||>.05
91707596|NCT04227405|183308938|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the control group||||<.001
91707597|NCT04227405|183308938|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the intervention group||||<.001
91707598|NCT04227405|183308938|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Conflict Management Satisfaction subscale||||<.001
91707599|NCT04227405|183308939|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
91707600|NCT04227405|183308939|SUPERIORITY||Slope|1.53|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the intervention group||||<.001
91707601|NCT04227405|183308939|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Positive Conflict Management subscale|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Positive Conflict Management subscale||||<.01
91707602|NCT04227405|183308939|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Negative Conflict subscale for the control group||||>.05
91771796|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.57||||0.1853|TWO_SIDED|95.0|0.48|43.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||43.19|0.48|0.1853
91771797|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|4.43||||0.217|TWO_SIDED|95.0|0.42|46.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.93|0.42|0.2170
91771798|NCT03192176|183427587|SUPERIORITY||Odds Ratio (OR)|0.74||||0.8354|TWO_SIDED|95.0|0.04|12.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||12.62|0.04|0.8354
91771799|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9671|TWO_SIDED|95.0|0.06|16.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.04|0.06|0.9671
91771800|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.16||||0.3289|TWO_SIDED|95.0|0.31|31.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.87|0.31|0.3289
91771801|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.26||||0.3157|TWO_SIDED|95.0|0.32|32.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||32.71|0.32|0.3157
91771802|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.0||||0.991|TWO_SIDED|95.0|0.06|16.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.83|0.06|0.991
91771803|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.26||||0.5139|TWO_SIDED|95.0|0.2|26.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||26.12|0.20|0.5139
91771804|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.32||||0.3079|TWO_SIDED|95.0|0.33|33.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||33.45|0.33|0.3079
91771805|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|8.83||||0.0469|TWO_SIDED|95.0|1.03|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||75.68|1.03|0.0469
91771806|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|14.39||||0.0134|TWO_SIDED|95.0|1.74|119.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||119.1|1.74|0.0134
91645406|NCT00297492|183182545|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was determined by a two-sided p value less than 0.05.|Chi-squared|Degrees of freedom = 2||"Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05."||||0.30
91707603|NCT04227405|183308939|SUPERIORITY||Slope|-1.4|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to Follow-up in the Negative Conflict Manageement subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
91707604|NCT04227405|183308939|SUPERIORITY||Slope|-0.99|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-i\[in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Negative Conflict Management subscale||||<.01
91707605|NCT04227405|183308939|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
91771807|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|4.98||||0.1606|TWO_SIDED|95.0|0.53|46.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||46.90|0.53|0.1606
91707606|NCT04227405|183308939|SUPERIORITY||Slope|0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the intervention group||||<.001
91707607|NCT04227405|183308939|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.26|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables. Pvalue set at \<.05|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Relationship Quality subscale||||<.10
91707608|NCT04227405|183308939|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group||||<.10
91707609|NCT04227405|183308939|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the intervention group||||<.001
91710569|NCT01677182|183313835|SUPERIORITY_OR_OTHER||Least Squares Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.98||0.783|TWO_SIDED|97.5|-1.4|3.0||Mixed Model Repeated Measures (MMRM) model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.0|-1.4|0.783
91710570|NCT01677182|183313835|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.97||0.329|TWO_SIDED|97.5|-2.6|1.7||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.7|-2.6|0.329
91710571|NCT01677182|183313836|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.27||0.088|TWO_SIDED|97.5|-0.1|1.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.1|-0.1|0.088
91710572|NCT01677182|183313836|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.642|TWO_SIDED|97.5|-0.7|0.5||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.5|-0.7|0.642
91519749|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.15|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.15
91710573|NCT01677182|183313837|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.792|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.792
91519750|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.05|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.05
91519751|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.08|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.08
91710574|NCT01677182|183313837|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.171|TWO_SIDED|97.5|-0.4|0.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.1|-0.4|0.171
91710575|NCT01677182|183313838|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.653|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.653
91710576|NCT01677182|183313838|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.673|TWO_SIDED|97.5|-0.3|0.2||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.2|-0.3|0.673
91710577|NCT01677182|183313839|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.51||0.119|TWO_SIDED|97.5|-0.4|2.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.0|-0.4|0.119
91710578|NCT01677182|183313839|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.791|TWO_SIDED|97.5|-1.3|1.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.0|-1.3|0.791
91710579|NCT01677182|183313840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.422|TWO_SIDED|97.5|-1.0|2.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.1|-1.0|0.422
91710580|NCT01677182|183313840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.655|TWO_SIDED|97.5|-1.3|1.9||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.9|-1.3|0.655
91645407|NCT00297492|183182545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.28|1.22|||||The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.|||1.22|0.28|
91645408|NCT02675426|183182546|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.1|||<|0.001|TWO_SIDED|95.0|19.1|37.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||37.0|19.1|<0.001
91645409|NCT02675426|183182546|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|21.6|39.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.4|21.6|<0.001
91645410|NCT02675426|183182547|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|23.0|39.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.5|23.0|<0.001
91645411|NCT02675426|183182547|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.8|||<|0.001|TWO_SIDED|95.0|22.5|39.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|22.5|<0.001
91645412|NCT02675426|183182548|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Least Squares (LS) Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.42|-0.94||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.94|-1.42|<0.001
91645413|NCT02675426|183182548|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.32|||<|0.001|TWO_SIDED|95.0|-1.56|-1.08||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.08|-1.56|<0.001
91645414|NCT02675426|183182549|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.24||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.24|-0.43|<0.001
91645415|NCT02675426|183182549|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.18|-0.38|<0.001
91645416|NCT02675426|183182550|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.55|||<|0.001|TWO_SIDED|95.0|3.13|5.98||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.98|3.13|<0.001
91645417|NCT02675426|183182550|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.98|||<|0.001|TWO_SIDED|95.0|3.54|6.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.42|3.54|<0.001
91645418|NCT02675426|183182551|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|20.8|||<|0.001|TWO_SIDED|95.0|13.6|28.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||28.1|13.6|<0.001
91710581|NCT01677182|183313841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|97.5|-4.5|2.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.8|-4.5|0.696
91645419|NCT02675426|183182551|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|18.4|||<|0.001|TWO_SIDED|95.0|11.2|25.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||25.5|11.2|<0.001
91645420|NCT02675426|183182552|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|21.3|||<|0.001|TWO_SIDED|95.0|13.0|29.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||29.5|13.0|<0.001
91645421|NCT02675426|183182552|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|23.0|||<|0.001|TWO_SIDED|95.0|14.7|31.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.3|14.7|<0.001
91645422|NCT02675426|183182553|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-51.01|||<|0.001|TWO_SIDED|95.0|-78.14|-23.87||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.87|-78.14|<0.001
91645423|NCT02675426|183182553|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-50.86|||<|0.001|TWO_SIDED|95.0|-78.19|-23.53||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.53|-78.19|<0.001
91645424|NCT02675426|183182554|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.95|||<|0.001|TWO_SIDED|95.0|3.31|6.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.60|3.31|<0.001
91645425|NCT02675426|183182554|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|3.12|6.44||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.44|3.12|<0.001
91645426|NCT02675426|183182555|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.0||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.0|15.1|<0.001
91645427|NCT02675426|183182555|SUPERIORITY||Response Rate Difference|28.4|||<|0.001|TWO_SIDED|95.0|20.4|36.5||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||36.5|20.4|<0.001
91645428|NCT02675426|183182556|SUPERIORITY||Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|8.7|21.1||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||21.1|8.7|<0.001
91645429|NCT02675426|183182556|SUPERIORITY||Response Rate Difference|20.6|||<|0.001|TWO_SIDED|95.0|14.0|27.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||27.2|14.0|<0.001
91645430|NCT02675426|183182557|SUPERIORITY||Response Rate Difference|13.6|||<|0.001|TWO_SIDED|95.0|7.0|20.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||20.2|7.0|<0.001
91645431|NCT02675426|183182557|SUPERIORITY||Response Rate Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.7|26.7||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use|Response Rate Difference = Upadacitinib - Placebo|||26.7|12.7|<0.001
91645432|NCT00080288|183182572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.0001||95.0|1.67|3.69|||ANCOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||3.69|1.67|<0.0001
91645433|NCT00080288|183182573|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0010
91519752|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.08|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.08
91519753|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.06|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.06
91519754|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.14|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.14
91519755|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.14|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.14
91519756|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.29|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.29
91519757|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.15|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.15
91707610|NCT04227405|183308939|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Emotional Abuse subscale||||<.10
91707611|NCT04227405|183308939|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship subscale for the control group||||>.05
91707612|NCT04227405|183308939|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Satisfaction subscale for the intervention group||||<.001
91707613|NCT04227405|183308939|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Satisfaction subscale||||<.001
91707614|NCT04227405|183308939|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
91707615|NCT04227405|183308939|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the intervention group||||<.001
91707616|NCT04227405|183308939|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Commitment subscale||||<.001
91707617|NCT04227405|183308939|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
91707618|NCT04227405|183308939|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for th eintervention group||||>.05
91519758|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.13|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.13
91707619|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
91707620|NCT04227405|183308939|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the control group||||>.05
91707621|NCT04227405|183308939|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the intervention group||||>.05
91707622|NCT04227405|183308939|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Negative Conflict Management subscale||||>.05
91707623|NCT04227405|183308939|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
91707624|NCT04227405|183308939|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the intervention group||||>.05
91707625|NCT04227405|183308939|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Quality subscale||||>.05
91707626|NCT04227405|183308939|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group||||>.05
91707627|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the intervention group||||>.05
91707628|NCT04227405|183308939|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Emotional Abuse subscale||||>.05
91707629|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the control group||||>.05
91519759|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.06|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.06
91707630|NCT04227405|183308939|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the interventionn group||||>.05
91707631|NCT04227405|183308939|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship satisfaction subscale||||>.05
91707632|NCT04227405|183308939|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from post-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
91707633|NCT04227405|183308939|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Commitment subscale for the intervention group||||>.05
91707634|NCT04227405|183308939|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Commitment subscale||||>.05
91707635|NCT04227405|183308939|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the control group||||>.05
91707636|NCT04227405|183308939|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the intervention group||||>.05
91707637|NCT04227405|183308939|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Banking subscale||||>.05
91707638|NCT04227405|183308939|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.001
91707639|NCT04227405|183308939|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the intervention group||||<.001
91707640|NCT04227405|183308939|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Banking subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||<.10
91707641|NCT04227405|183308939|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulty to Pay Bills for the control group||||>.05
91707642|NCT04227405|183308939|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||<.05
91581634|NCT02349425|183053230|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|95.0|1.66|5.38|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.38|1.66|<0.001
91645434|NCT01875991|183182622|SUPERIORITY_OR_OTHER|||||||0.501|||||||Van Elteren test|P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)||||||0.501
91707643|NCT04227405|183308939|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Difficulties to pay bills subscale||||>.05
91707644|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulty to Pay Bills subscale for the control group||||>.05
91707645|NCT04227405|183308939|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||>.05
91707646|NCT04227405|183308939|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Difficulty to Pay Bills subscale||||>.05
91707647|NCT04227405|183308939|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment to p vallue|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the control group||||<.001
91707648|NCT04227405|183308939|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the intervention group||||<.001
91707649|NCT04227405|183308939|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Depression subscale||||>.05
91707650|NCT04227405|183308939|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the control group||||>.05
91581635|NCT02349425|183053231|SUPERIORITY||Mean Difference (Final Values)|-10.6||||0.096|TWO_SIDED|95.0|-23.2|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-23.2|0.096
91645435|NCT04971226|183182636|SUPERIORITY||Risk Difference (RD)|18.88|||<|0.001|TWO_SIDED|95.0|9.59|28.17|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|28.17|9.59|<0.001
91645436|NCT04971226|183182668|SUPERIORITY||Risk Difference (RD)|29.55|||<|0.001|TWO_SIDED|95.0|16.91|42.18|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|42.18|16.91|<0.001
91645437|NCT03131817|183182777|OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91645438|NCT03131817|183182778|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
91645439|NCT03131817|183182779|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||"This statistical analysis corresponds to the first outcome row, Reward magnitude effect (higher reward, higher acceptance). The generalized linear mixed model examined the effect of reward magnitude on the probability of accepting offers."||||<0.0001
91645440|NCT03131817|183182779|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||"This statistical analysis corresponds to the second outcome row, Effort cost effect (higher effort, lower acceptance). The generalized linear mixed model examined the effect of effort cost on the probability of accepting offers."||||<0.0001
91645441|NCT05734014|183182828|OTHER||||||||||||||||||Qualitative Analysis of arts-based reflections. Thematic analysis and count of whether the participant drew or mentioned Crow stories related to relationality.|||
91645442|NCT00379821|183182841|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0413|STANDARD_ERROR_OF_MEAN|0.1746||0.8097|TWO_SIDED|95.0|0.7497|1.4463||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4463|0.7497|0.8097
91645443|NCT00379821|183182841|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1623|STANDARD_ERROR_OF_MEAN|0.1973||0.3767|TWO_SIDED|95.0|0.8333|1.6211||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.6211|0.8333|0.3767
91645444|NCT00379821|183182841|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0707|STANDARD_ERROR_OF_MEAN|0.1795||0.6277|TWO_SIDED|95.0|0.7708|1.4872||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4872|0.7708|0.6277
91645445|NCT00379821|183182875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|STANDARD_ERROR_OF_MEAN|0.17||0.79|TWO_SIDED|95.0|0.68|1.34||Not adjusted, 0.05|Regression, Cox|There are no adjustments.|The reference category is those who did not travel.|||1.34|0.68|0.79
91645446|NCT00633217|183182879|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% confidence interval for the mean difference in 2-hour post-dose FEV1 change from baseline fell above -75 mL, then HFA MDI could be deemed non-inferior to DISKUS treatment response.||||||0.021||95.0|||||ANCOVA|||||||0.021
91645447|NCT05838755|183182882|OTHER|Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors.|Posterior Mean Difference|-0.65|||||TWO_SIDED|95.0|-1.47|0.18|||||Posterior mean difference with 95% credible interval is reported using Bayesian mixed model repeated measures analysis.|||0.18|-1.47|
91645448|NCT05838755|183182882|OTHER|Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors.|Posterior Mean Difference|-0.22|||||TWO_SIDED|95.0|-1.04|0.61|||||Posterior mean difference with 95% credible interval is reported using Bayesian mixed model repeated measures analysis.|||0.61|-1.04|
91645449|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.656|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.032|7.344|||||Hydromorphone - Placebo|"Week 1~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||7.344|-0.032|
91645450|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.927|STANDARD_ERROR_OF_MEAN|1.848|||TWO_SIDED|95.0|3.243|10.612|||||Hydromorphone - Placebo|Week 1 Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05.||10.612|3.243|
91645451|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.586|STANDARD_ERROR_OF_MEAN|1.283|||TWO_SIDED|95.0|-1.977|3.149|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||3.149|-1.977|
91645452|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|2.899|STANDARD_ERROR_OF_MEAN|1.285|||TWO_SIDED|95.0|0.333|5.465|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||5.465|0.333|
91707651|NCT04227405|183308939|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the intervention group||||>.05
91645453|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.863|STANDARD_ERROR_OF_MEAN|1.959|||TWO_SIDED|95.0|-3.053|4.778|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||4.778|-3.053|
91645454|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|4.926|STANDARD_ERROR_OF_MEAN|1.956|||TWO_SIDED|95.0|1.016|8.837|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.837|1.016|
91645455|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.316|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|-1.425|8.025|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.025|-1.425|
91645456|NCT02044094|183182931|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.677|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|1.936|11.418|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||11.418|1.936|
91645457|NCT03205163|183182962|OTHER||GMR|1.35||||0.032|TWO_SIDED|95.0|1.04|1.77|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an analysis of variance (ANOVA) model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and geometric mean ratio (GMR) were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.77|1.04|0.032
91645458|NCT03205163|183182963|OTHER||GMR|1.17|||<|0.001|TWO_SIDED|95.0|1.09|1.25|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.25|1.09|<0.001
91645459|NCT03205163|183182964|OTHER||GMR|4.13|||<|0.001|TWO_SIDED|95.0|2.94|5.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.79|2.94|<0.001
91645460|NCT03205163|183182965|OTHER||GMR|3.24|||<|0.001|TWO_SIDED|95.0|2.76|3.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||3.79|2.76|<0.001
91645461|NCT03205163|183182966|OTHER||GMR|0.143|||<|0.001|TWO_SIDED|95.0|0.118|0.172|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.172|0.118|<0.001
91645462|NCT03205163|183182967|OTHER||GMR|0.153|||<|0.001|TWO_SIDED|95.0|0.138|0.17|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.170|0.138|<0.001
91645463|NCT03205163|183182968|OTHER||GMR|0.622||||0.003|TWO_SIDED|95.0|0.492|0.786|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.786|0.492|0.003
91645464|NCT03205163|183182969|OTHER||GMR|0.599|||<|0.001|TWO_SIDED|95.0|0.525|0.684|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.684|0.525|<0.001
91645465|NCT03205163|183182970|OTHER||GMR|7.0|||<|0.001|TWO_SIDED|95.0|5.78|8.48|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||8.48|5.78|<0.001
91645466|NCT03205163|183182971|OTHER||GMR|6.54|||<|0.001|TWO_SIDED|95.0|5.89|7.27|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||7.27|5.89|<0.001
91645467|NCT03205163|183182972|OTHER||GMR|4.54|||<|0.001|TWO_SIDED|95.0|3.64|5.66|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.66|3.64|<0.001
91645468|NCT03205163|183182973|OTHER||GMR|4.32|||<|0.001|TWO_SIDED|95.0|3.96|4.72|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.72|3.96|<0.001
91707652|NCT04227405|183308939|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in depression subscale||||>.05
91707653|NCT04227405|183308939|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to follow-up in the Anxiety subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
91707654|NCT04227405|183308939|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Anxiety subscale for the intervention group||||<.05
91707655|NCT04227405|183308939|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Anxiety subscale||||>.05
91707656|NCT04227405|183308939|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
91707657|NCT04227405|183308939|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
91707658|NCT04227405|183308939|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the Anxiety subscale||||>.05
91707659|NCT04227405|183308939|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the control group||||>.05
91707660|NCT04227405|183308939|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the intervention group||||>.05
91707661|NCT04227405|183308939|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in parenting stress subscale|Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|||>.05
91519760|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.09|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.09
91519761|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.37|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.37
91707662|NCT04227405|183308939|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.05
91707663|NCT04227405|183308939|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in parenting stress subscale for the control group||||>.05
91707664|NCT04227405|183308939|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Parenting Stress subscale||||>.05
91707665|NCT04227405|183308939|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Partner subscale for the control group||||<.10
91707666|NCT04227405|183308939|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Parter subscale for the intervention group||||>.05
91707667|NCT04227405|183308939|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.2|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn Time with Partner subscale||||>.05
91707668|NCT04227405|183308939|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the control group||||<.001
91707669|NCT04227405|183308939|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the intervention group||||>.05
91645469|NCT03205163|183182974|OTHER||GMR|1.36||||0.063|TWO_SIDED|95.0|0.978|1.89|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.89|0.978|0.063
91645470|NCT03205163|183182975|OTHER||GMR|1.18|||<|0.001|TWO_SIDED|95.0|1.1|1.26|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.26|1.10|<0.001
91645471|NCT03205163|183182976|OTHER||GMR|4.57|||<|0.001|TWO_SIDED|95.0|4.0|5.23|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.23|4.00|<0.001
91645472|NCT03205163|183182977|OTHER||GMR|4.46|||<|0.001|TWO_SIDED|95.0|4.16|4.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.79|4.16|<0.001
91645473|NCT01238172|183182980|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.76|TWO_SIDED|95.0|0.75|1.24|||Log Rank|||||1.24|0.75|0.76
91645474|NCT01238172|183182981|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.71|TWO_SIDED|95.0|0.23|8.41|||Log Rank|||||8.41|0.23|0.71
91645475|NCT01238172|183182982|SUPERIORITY|||||||0.995|||||||Wilcoxon (Mann-Whitney)|||||||0.995
91645476|NCT01238172|183182983|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Two-sided||||||<0.001
91645477|NCT03229941|183183000|SUPERIORITY||Odds Ratio (OR)|0.89||||0.515|TWO_SIDED|95.0|0.62|1.27|||Chi-squared||Liberal vs. restrictive arm comparison.|||1.27|0.62|0.515
91645478|NCT03229941|183183001|SUPERIORITY||Odds Ratio (OR)|1.09||||0.587|TWO_SIDED|99.0|0.73|1.61|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.61|0.73|0.587
91645479|NCT03229941|183183002|SUPERIORITY||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|99.0|0.33|0.98|||Chi-squared||Liberal vs. Restrictive arm comparison|||0.98|0.33|0.007
91645480|NCT03229941|183183003|SUPERIORITY||Odds Ratio (OR)|0.93||||0.634|TWO_SIDED|99.0|0.63|1.38|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.38|0.63|0.634
91645481|NCT03229941|183183004|SUPERIORITY||Odds Ratio (OR)|0.75||||0.212|TWO_SIDED|99.0|0.41|1.37|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.37|0.41|0.212
91645482|NCT03229941|183183005|SUPERIORITY|||||||0.786|||||||Wilcoxon (Mann-Whitney)|||||||0.786
91645483|NCT01020773|183183006|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91645484|NCT03302299|183183009|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.01|TWO_SIDED|95.0|0.94|2.71||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR for participants with moderate alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||2.71|0.94|<0.01
91645485|NCT03302299|183183009|SUPERIORITY||Odds Ratio (OR)|2.78|||<|0.01|TWO_SIDED|95.0|1.62|4.76||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR is for participants with unhealthy alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||4.76|1.62|<0.01
91645486|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|81.1237||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for entry criteria||||||0.0001
91645487|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.973||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for model entry||||||0.0001
91645488|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|7.1526||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% significance level for entry criteria||||||0.0075
91645489|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.409||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% Significance Level for model entry||||||0.0075
91645490|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|51.8456||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% significance level for entry criteria||||||0.0001
91645491|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.515||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
91645492|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|98.1065||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
91645493|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.929||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
91645494|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|2.8589||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for entry criteria||||||0.0909
91645495|NCT01788163|183183055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for model entry||||||0.0909
91645496|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|11.106||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for entry criteria||||||0.0009
91645497|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.561||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for model entry||||||0.0009
91645498|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|34.1075||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
91645499|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.386||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% significance level for model entry||||||0.0001
91645500|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|14.0806||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for entry criteria||||||0.0002
91707670|NCT04227405|183308939|SUPERIORITY||Slope|0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Time with Partner subscale|Changes from post-test to follow-up in the intervention group were significantly different from the change from post-test to follow-up in the control group|||<.001
91707671|NCT04227405|183308939|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.05
91707672|NCT04227405|183308939|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.001
91707673|NCT04227405|183308939|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Conflict Management Satisfaction subscale||||<.05
91707674|NCT04227405|183308939|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Conflict Management Satisfaction subscale for the control group||||>.05
91771808|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|6.69||||0.0854|TWO_SIDED|95.0|0.77|58.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||58.35|0.77|0.0854
91771809|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|6.07||||0.1082|TWO_SIDED|95.0|0.67|54.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||54.72|0.67|0.1082
91771810|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|7.22||||0.0737|TWO_SIDED|95.0|0.83|63.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||63.04|0.83|0.0737
91771811|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|11.98||||0.0217|TWO_SIDED|95.0|1.44|99.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||99.74|1.44|0.0217
91771812|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|19.24||||0.0058|TWO_SIDED|95.0|2.36|157.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||157.1|2.36|0.0058
91771813|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|4.44||||0.1924|TWO_SIDED|95.0|0.47|41.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||41.87|0.47|0.1924
91771814|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|7.54||||0.068|TWO_SIDED|95.0|0.86|66.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||66.00|0.86|0.0680
91771815|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|15.95||||0.0095|TWO_SIDED|95.0|1.97|129.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||129.4|1.97|0.0095
91771816|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.68||||0.269|TWO_SIDED|95.0|0.36|37.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||37.21|0.36|0.2690
91771817|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|10.28||||0.0321|TWO_SIDED|95.0|1.22|86.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||86.53|1.22|0.0321
91771818|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|14.48||||0.0131|TWO_SIDED|95.0|1.75|119.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||119.7|1.75|0.0131
91771819|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|25.22||||0.0025|TWO_SIDED|95.0|3.11|204.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||204.6|3.11|0.0025
91771820|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|4.65||||0.1788|TWO_SIDED|95.0|0.49|43.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.72|0.49|0.1788
91771821|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|10.33||||0.032|TWO_SIDED|95.0|1.22|87.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||87.31|1.22|0.0320
91645501|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for model entry||||||0.0002
91645502|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|33.8574||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
91645503|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.077||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
91645504|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|21.2537||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
91645505|NCT01788163|183183058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.084||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
91645506|NCT03610646|183183063|EQUIVALENCE|An equivalence margin of \[-3, 3\] letters was used to demonstrate equivalence for the difference of mean change in BCVA, from baseline to Week 8.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|-1.16|1.24||||||||1.24|-1.16|
91645507|NCT04318535|183183083|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of Cmax falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.157|||||TWO_SIDED|90.0|1.103|1.213|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.213|1.103|
91645508|NCT04318535|183183084|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-t) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.032|||||TWO_SIDED|90.0|0.974|1.094|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.094|0.974|
91645509|NCT04318535|183183085|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-inf) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.971|1.093|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.093|0.971|
91645510|NCT00883740|183183182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.15|||<|0.0001|TWO_SIDED|95.0|-26.69|-11.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.61|-26.69|<0.0001
91645511|NCT00883740|183183183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.54|||<|0.0001|TWO_SIDED|95.0|-23.29|-11.8||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.80|-23.29|<0.0001
91771822|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|11.24||||0.0251|TWO_SIDED|95.0|1.35|93.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||93.33|1.35|0.0251
91645512|NCT00883740|183183184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81||||0.3841|TWO_SIDED|95.0|-5.92|2.3||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||2.30|-5.92|0.3841
91645513|NCT00883740|183183185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.54|||<|0.0001|TWO_SIDED|95.0|17.48|33.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||33.61|17.48|<0.0001
91645514|NCT00883740|183183186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.42|||<|0.0001|TWO_SIDED|95.0|3.74|7.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||7.11|3.74|<0.0001
91645515|NCT00883740|183183187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.41||||0.0135|TWO_SIDED|95.0|-4.31|-0.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.51|-4.31|0.0135
91645516|NCT00883740|183183188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.53||||0.0008|TWO_SIDED|95.0|-2.41|-0.66||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.66|-2.41|0.0008
91645517|NCT00883740|183183189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.18||||0.0447|TWO_SIDED|95.0|-14.18|-0.17||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.17|-14.18|0.0447
91645518|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.3613|TWO_SIDED|95.0|-1.07|0.39||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 1||0.39|-1.07|0.3613
91645519|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0686|TWO_SIDED|95.0|-2.29|0.09||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 2||0.09|-2.29|0.0686
91645520|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.0009|TWO_SIDED|95.0|-3.85|-1.03||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 3||-1.03|-3.85|0.0009
91645521|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.52||||0.0002|TWO_SIDED|95.0|-5.33|-1.71||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 4||-1.71|-5.33|0.0002
91771823|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.43||||0.6154|TWO_SIDED|95.0|0.35|5.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.83|0.35|0.6154
91771824|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1906|TWO_SIDED|95.0|0.65|8.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.63|0.65|0.1906
91771825|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.67||||0.045|TWO_SIDED|95.0|1.03|13.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.07|1.03|0.0450
91771826|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0017|TWO_SIDED|95.0|2.1|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||24.66|2.10|0.0017
91771827|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3939|TWO_SIDED|95.0|0.47|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.97|0.47|0.3939
91771828|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2869|TWO_SIDED|95.0|0.55|7.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.74|0.55|0.2869
91771829|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1817|TWO_SIDED|95.0|0.66|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.80|0.66|0.1817
91519762|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.18|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.18
91519763|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.24|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.24
91519764|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.24|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.24
91519765|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.19|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.19
91771830|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|11.41||||0.0256|TWO_SIDED|95.0|1.35|96.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||96.77|1.35|0.0256
91771831|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||112.8|1.65|0.0153
91771832|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|21.76||||0.0042|TWO_SIDED|95.0|2.64|179.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||179.2|2.64|0.0042
91771833|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|35.75||||0.0008|TWO_SIDED|95.0|4.39|291.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||291.5|4.39|0.0008
91771834|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|6.45||||0.0967|TWO_SIDED|95.0|0.71|58.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||58.21|0.71|0.0967
91771835|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0564|TWO_SIDED|95.0|0.94|72.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.95|0.94|0.0564
91771836|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|23.63||||0.003|TWO_SIDED|95.0|2.93|190.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||190.5|2.93|0.0030
91581636|NCT02349425|183053231|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.005|TWO_SIDED|95.0|-33.6|-6.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.3|-33.6|0.005
91771837|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|9.72||||0.0384|TWO_SIDED|95.0|1.13|83.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||83.68|1.13|0.0384
91771838|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||112.9|1.65|0.0153
91771839|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|30.55||||0.0015|TWO_SIDED|95.0|3.72|250.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||250.6|3.72|0.0015
91771840|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|35.99||||0.0008|TWO_SIDED|95.0|4.41|293.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||293.5|4.41|0.0008
91771841|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|12.67||||0.0192|TWO_SIDED|95.0|1.51|106.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.1|1.51|0.0192
91771842|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|16.92||||0.0089|TWO_SIDED|95.0|2.03|141.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||141.0|2.03|0.0089
91771843|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|24.96||||0.0025|TWO_SIDED|95.0|3.09|201.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||201.6|3.09|0.0025
91771844|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.03||||0.091|TWO_SIDED|95.0|0.84|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.94|0.84|0.0910
91771845|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0296|TWO_SIDED|95.0|1.15|13.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.67|1.15|0.0296
91581637|NCT02349425|183053231|SUPERIORITY||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-40.7|-11.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.6|-40.7|<0.001
91771846|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|8.23||||0.0009|TWO_SIDED|95.0|2.38|28.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||28.44|2.38|0.0009
91771847|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|8.54||||0.0007|TWO_SIDED|95.0|2.46|29.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||29.63|2.46|0.0007
91771848|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4152|TWO_SIDED|95.0|0.45|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.86|0.45|0.4152
91771849|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.29||||0.07|TWO_SIDED|95.0|0.91|11.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.93|0.91|0.0700
91771850|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|5.83||||0.0048|TWO_SIDED|95.0|1.71|19.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.84|1.71|0.0048
91771851|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1497|TWO_SIDED|95.0|0.72|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.23|0.72|0.1497
91771852|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0608|TWO_SIDED|95.0|0.95|9.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.77|0.95|0.0608
91771853|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0028|TWO_SIDED|95.0|1.85|19.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.34|1.85|0.0028
91771854|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|7.84||||0.0005|TWO_SIDED|95.0|2.45|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.13|2.45|0.0005
91645522|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.0065|TWO_SIDED|95.0|-5.16|-0.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 5||-0.86|-5.16|0.0065
91645523|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89||||0.0024|TWO_SIDED|95.0|-6.36|-1.41||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 6||-1.41|-6.36|0.0024
91519766|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.32|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.32
91645524|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.59||||0.0366|TWO_SIDED|95.0|-5.01|-0.16||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 7||-0.16|-5.01|0.0366
91645525|NCT00883740|183183190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85||||0.0593|TWO_SIDED|95.0|-5.82|0.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 8||0.11|-5.82|0.0593
91645526|NCT00883740|183183191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25||||0.1106|TWO_SIDED|95.0|-2.79|0.29||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 1||0.29|-2.79|0.1106
91645527|NCT00883740|183183191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.0|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 2||-3.51|-8.49|<0.0001
91645528|NCT00883740|183183191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.83||||0.0004|TWO_SIDED|95.0|-10.53|-3.13||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 3||-3.13|-10.53|0.0004
91645529|NCT00883740|183183191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.44||||0.0199|TWO_SIDED|95.0|-10.0|-0.88||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 4||-0.88|-10.00|0.0199
91771855|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8393|TWO_SIDED|95.0|0.3|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.39|0.30|0.8393
91519767|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.32|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.32
91645530|NCT00883740|183183192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|0.78|3.5||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||3.50|0.78|0.0024
91645531|NCT00883740|183183193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.13||||0.0591|TWO_SIDED|95.0|-16.59|0.32||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||0.32|-16.59|0.0591
91645532|NCT00883740|183183193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.81|||<|0.0001|TWO_SIDED|95.0|-27.43|-10.2||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-10.20|-27.43|<0.0001
91645533|NCT00883740|183183194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.47||||0.1101|TWO_SIDED|95.0|-12.2|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||1.26|-12.20|0.1101
91645534|NCT00883740|183183194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.39||||0.0002|TWO_SIDED|95.0|-20.36|-6.42||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-6.42|-20.36|0.0002
91645535|NCT00883740|183183195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||1.24|0.58|<0.0001
91645536|NCT00883740|183183195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|||<|0.0001|TWO_SIDED|95.0|0.76|1.53||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||1.53|0.76|<0.0001
91645537|NCT00883740|183183195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.46|1.28||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||1.28|0.46|<0.0001
91645538|NCT00883740|183183195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||<|0.0001|TWO_SIDED|95.0|0.51|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||1.26|0.51|<0.0001
91645539|NCT00883740|183183196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.66||||0.0001|TWO_SIDED|95.0|-11.44|-3.89||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-3.89|-11.44|0.0001
91645540|NCT00883740|183183196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.67||||0.0077|TWO_SIDED|95.0|-13.27|-2.07||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-2.07|-13.27|0.0077
91645541|NCT00883740|183183196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.68||||0.2196|TWO_SIDED|95.0|-14.81|3.44||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||3.44|-14.81|0.2196
91519768|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.52|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.52
91519769|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.33|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.33
91519770|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.29|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.29
91519771|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.43|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.43
91519772|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.29|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.29
91519773|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.7|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.70
91645542|NCT00883740|183183196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.18||||0.0081|TWO_SIDED|95.0|-10.73|-1.64||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-1.64|-10.73|0.0081
91519774|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.71|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.71
91519775|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.61|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.61
91519776|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.48|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.48
91519777|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.58|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.58
91519778|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.83|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.83
91519779|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.74|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.74
91771856|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|4.01||||0.0215|TWO_SIDED|95.0|1.23|13.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.10|1.23|0.0215
91771857|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|4.42||||0.0112|TWO_SIDED|95.0|1.4|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.94|1.40|0.0112
91771858|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3498|TWO_SIDED|95.0|0.55|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.29|0.55|0.3498
91771859|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1981|TWO_SIDED|95.0|0.69|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.08|0.69|0.1981
91771860|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0029|TWO_SIDED|95.0|1.76|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.78|1.76|0.0029
91519780|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.89|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.89
91519781|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.59|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.59
91519782|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.77|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.77
91519783|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.01|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.01
91645543|NCT00883740|183183197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-0.37|-1.02|<0.0001
91645544|NCT00883740|183183197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0001|TWO_SIDED|95.0|-1.06|-0.36||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-0.36|-1.06|0.0001
91645545|NCT00883740|183183197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.95|-0.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-0.24|-0.95|0.0014
91645546|NCT00883740|183183197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.0084|TWO_SIDED|95.0|-0.9|-0.14||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-0.14|-0.90|0.0084
91771861|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|5.95||||0.0011|TWO_SIDED|95.0|2.03|17.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.40|2.03|0.0011
91771862|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9511|TWO_SIDED|95.0|0.29|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.29|0.9511
91771863|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.76||||0.3241|TWO_SIDED|95.0|0.57|5.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.45|0.57|0.3241
91771864|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0111|TWO_SIDED|95.0|1.36|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||11.16|1.36|0.0111
91771865|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1375|TWO_SIDED|95.0|0.74|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.48|0.74|0.1375
91771866|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.02||||0.067|TWO_SIDED|95.0|0.93|9.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.83|0.93|0.0670
91771867|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0009|TWO_SIDED|95.0|2.29|25.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.04|2.29|0.0009
91771868|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|9.42||||0.0002|TWO_SIDED|95.0|2.91|30.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||30.49|2.91|0.0002
91771869|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0982|TWO_SIDED|95.0|0.83|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.14|0.83|0.0982
91771870|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1233|TWO_SIDED|95.0|0.77|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.80|0.77|0.1233
91771871|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0091|TWO_SIDED|95.0|1.46|14.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.64|1.46|0.0091
91771872|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.10|0.34|0.9620
91771873|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3527|TWO_SIDED|95.0|0.58|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.59|0.58|0.3527
91519784|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.01
91771874|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0394|TWO_SIDED|95.0|1.06|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.76|1.06|0.0394
91581638|NCT02349425|183053231|SUPERIORITY||Mean Difference (Final Values)|-33.8|||<|0.001|TWO_SIDED|95.0|-48.4|-19.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-19.1|-48.4|<0.001
91645547|NCT00883740|183183198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.0001|TWO_SIDED|95.0|-27.02|-9.52||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-9.52|-27.02|<0.0001
91771875|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0224|TWO_SIDED|95.0|1.19|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.53|1.19|0.0224
91771876|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7891|TWO_SIDED|95.0|0.39|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.44|0.39|0.7891
91771877|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.48||||0.0851|TWO_SIDED|95.0|0.88|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.99|0.88|0.0851
91771878|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2885|TWO_SIDED|95.0|0.63|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.83|0.63|0.2885
91771879|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8611|TWO_SIDED|95.0|0.05|13.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||13.30|0.05|0.8611
91771880|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.48||||0.7549|TWO_SIDED|95.0|0.13|17.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.42|0.13|0.7549
91771881|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|2.07||||0.5658|TWO_SIDED|95.0|0.17|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||24.66|0.17|0.5658
91771882|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.83||||0.6319|TWO_SIDED|95.0|0.15|21.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||21.86|0.15|0.6319
91645548|NCT00883740|183183198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.06||||0.0002|TWO_SIDED|95.0|-24.24|-7.87||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-7.87|-24.24|0.0002
91645549|NCT00883740|183183198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.23||||0.0085|TWO_SIDED|95.0|-23.01|-3.46||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-3.46|-23.01|0.0085
91645550|NCT00883740|183183198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.25||||0.0102|TWO_SIDED|95.0|-18.01|-2.48||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-2.48|-18.01|0.0102
91645551|NCT00883740|183183199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.82|||<|0.0001|TWO_SIDED|95.0|13.25|36.4||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||36.40|13.25|<0.0001
91645552|NCT00883740|183183199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.4|||<|0.0001|TWO_SIDED|95.0|18.59|40.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||40.21|18.59|<0.0001
91645553|NCT00883740|183183199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.79|||<|0.0001|TWO_SIDED|95.0|15.37|38.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||38.21|15.37|<0.0001
91645554|NCT00883740|183183199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.44|||<|0.0001|TWO_SIDED|95.0|15.03|35.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||35.86|15.03|<0.0001
91645555|NCT00396981|183183248|NON_INFERIORITY_OR_EQUIVALENCE|This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin||||||0.76|||||||Log Rank|||Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)||||0.76
91645556|NCT02494583|183183255|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03918|TWO_SIDED|95.0|0.7|1.02||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.02|0.70|0.03918
91645557|NCT02494583|183183256|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.04611|TWO_SIDED|95.0|0.7|1.03||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.03|0.70|0.04611
91645558|NCT02494583|183183257|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.15804|TWO_SIDED|95.0|0.62|1.17||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.17|0.62|0.15804
91645559|NCT02494583|183183258|NON_INFERIORITY|Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|99.2|0.69|1.18|||||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.18|0.69|
91645560|NCT02494583|183183258|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.16205|TWO_SIDED|95.0|0.74|1.1||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.10|0.74|0.16205
91771883|NCT03192176|183427588|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9526|TWO_SIDED|95.0|0.06|18.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||18.96|0.06|0.9526
91519785|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.09|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.09
91519786|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.09|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.09
91519787|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.05|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.05
91519788|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.02|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.02
91771884|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2251|TWO_SIDED|95.0|0.71|4.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.26|0.71|0.2251
91771885|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0084|TWO_SIDED|95.0|1.39|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.39|0.0084
91771886|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.71||||0.0007|TWO_SIDED|95.0|2.09|15.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.62|2.09|0.0007
91771887|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.11||||0.0015|TWO_SIDED|95.0|1.87|14.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.00|1.87|0.0015
91519789|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.04|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.04
91519790|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.22|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.22
91519791|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.14|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.14
91519792|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.36|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.36
91519793|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.07|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.07
91519794|NCT02130193|182913602|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.17|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.17
91519795|NCT01212770|182913607|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.3|||<|0.0001|TWO_SIDED|95.0|13.0|31.6|||Cochran-Mantel-Haenszel|Adjusted for baseline disease modifying antirheumatic drug (DMARD) use and and ≥ 3% body surface area (BSA) psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|The percentage of participants with an ACR20 response was compared using a Cochran-Mantel- Haenszel (CMH) test. The Hochberg procedure was used to maintain the Type 1 error at the 0.05 significance level. The results were considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||31.6|13.0|<0.0001
91581639|NCT02349425|183053232|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.311|TWO_SIDED|95.0|-19.1|6.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||6.2|-19.1|0.311
91771888|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6976|TWO_SIDED|95.0|0.48|2.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||2.95|0.48|0.6976
91771889|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|4.57||||0.0021|TWO_SIDED|95.0|1.73|12.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.05|1.73|0.0021
91771890|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0171|TWO_SIDED|95.0|1.22|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.68|1.22|0.0171
91581640|NCT02349425|183053232|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.232|TWO_SIDED|95.0|-19.7|4.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.9|-19.7|0.232
91581641|NCT02349425|183053232|SUPERIORITY||Mean Difference (Final Values)|-15.6||||0.012|TWO_SIDED|95.0|-27.6|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-27.6|0.012
91581642|NCT02349425|183053232|SUPERIORITY||Mean Difference (Final Values)|-15.4||||0.043|TWO_SIDED|95.0|-30.4|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-30.4|0.043
91645561|NCT02494583|183183259|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.01491|TWO_SIDED|95.0|0.49|0.97||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||0.97|0.49|0.01491
91645562|NCT02494583|183183260|OTHER||Difference in ORR Percentage|11.5||||0.00447|TWO_SIDED|95.0|2.9|20.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||20.0|2.9|0.00447
91645563|NCT02494583|183183262|OTHER||Difference in ORR Percentage|-22.3|||>|0.99999|TWO_SIDED|95.0|-29.6|-14.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||-14.9|-29.6|>0.99999
91707675|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in conflict management satisfaction subscale for the intervention group||||>.05
91707676|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Conflict Management Satisfaction subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||>.05
91707677|NCT04227405|183308939|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in budgeting subscale for the control group||||<.10
91707678|NCT04227405|183308939|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Budgeting subscale for the intervention group||||<.05
91707679|NCT04227405|183308939|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.01
91707680|NCT04227405|183308939|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the control group||||<.001
91771891|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2224|TWO_SIDED|95.0|0.69|5.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.04|0.69|0.2224
91707681|NCT04227405|183308939|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the intervention group||||<.001
91707682|NCT04227405|183308939|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.001
91707683|NCT04227405|183308941|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
91707684|NCT04227405|183308941|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the intervention group||||<.05
91707685|NCT04227405|183308941|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
91707686|NCT04227405|183308941|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||<.05
91707687|NCT04227405|183308941|SUPERIORITY||Slope|0.38|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.05
91707688|NCT04227405|183308941|SUPERIORITY||Slope|0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.001
91707689|NCT04227405|183308941|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
91707690|NCT04227405|183308941|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the intervention group||||<.01
91707691|NCT04227405|183308941|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
91707692|NCT04227405|183308941|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
91707693|NCT04227405|183308941|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||>.05
91707694|NCT04227405|183308941|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||>.05
91707695|NCT04227405|183308942|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.14|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||<.10
91707696|NCT04227405|183308942|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.05
91707697|NCT04227405|183308942|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Aceptance subscale||||<.001
91707698|NCT04227405|183308942|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||<.10
91771892|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2716|TWO_SIDED|95.0|0.65|4.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.69|0.65|0.2716
91771893|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0112|TWO_SIDED|95.0|1.41|14.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.32|1.41|0.0112
91771894|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0461|TWO_SIDED|95.0|1.02|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.31|1.02|0.0461
91771895|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3463|TWO_SIDED|95.0|0.59|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.47|0.59|0.3463
91771896|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0419|TWO_SIDED|95.0|1.04|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.92|1.04|0.0419
91771897|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2977|TWO_SIDED|95.0|0.63|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.46|0.63|0.2977
91581643|NCT01190514|183053266|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|95.56|||||TWO_SIDED|90.0|86.94|105.04|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.04|86.94|
91771898|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|95.0|0.67|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.21|0.67|0.2300
91771899|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0655|TWO_SIDED|95.0|0.94|8.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.58|0.94|0.0655
91771900|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0245|TWO_SIDED|95.0|1.19|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.11|1.19|0.0245
91771901|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0129|TWO_SIDED|95.0|1.44|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.93|1.44|0.0129
91771902|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1259|TWO_SIDED|95.0|0.79|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.15|0.79|0.1259
91771903|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1015|TWO_SIDED|95.0|0.84|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.82|0.84|0.1015
91771904|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0167|TWO_SIDED|95.0|1.31|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.33|1.31|0.0167
91771905|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5232|TWO_SIDED|95.0|0.5|3.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.95|0.50|0.5232
91771906|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.0||||0.2055|TWO_SIDED|95.0|0.68|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.68|0.2055
91771907|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0658|TWO_SIDED|95.0|0.93|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.64|0.93|0.0658
91771908|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0136|TWO_SIDED|95.0|1.51|35.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||35.75|1.51|0.0136
91771909|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3238|TWO_SIDED|95.0|0.59|5.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.00|0.59|0.3238
91771910|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0118|TWO_SIDED|95.0|1.48|23.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||23.21|1.48|0.0118
91771911|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.29||||0.0163|TWO_SIDED|95.0|1.36|20.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||20.62|1.36|0.0163
91771912|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6363|TWO_SIDED|95.0|0.42|4.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.18|0.42|0.6363
91771913|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0722|TWO_SIDED|95.0|0.89|15.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.25|0.89|0.0722
91771914|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2019|TWO_SIDED|95.0|0.63|8.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.73|0.63|0.2019
91771915|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|10.15||||0.0337|TWO_SIDED|95.0|1.2|86.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||86.09|1.20|0.0337
91771916|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.25||||0.2207|TWO_SIDED|95.0|0.61|8.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.24|0.61|0.2207
91771917|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.5||||0.0849|TWO_SIDED|95.0|0.84|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.57|0.84|0.0849
91771918|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0844|TWO_SIDED|95.0|0.84|14.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.24|0.84|0.0844
91771919|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2383|TWO_SIDED|95.0|0.6|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.65|0.60|0.2383
91771920|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1653|TWO_SIDED|95.0|0.68|9.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.58|0.68|0.1653
91771921|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1836|TWO_SIDED|95.0|0.65|9.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.48|0.65|0.1836
91771922|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0529|TWO_SIDED|95.0|0.97|70.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||70.80|0.97|0.0529
91771923|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3197|TWO_SIDED|95.0|0.52|7.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.27|0.52|0.3197
91771924|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.88||||0.0376|TWO_SIDED|95.0|1.11|31.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||31.25|1.11|0.0376
91771925|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0343|TWO_SIDED|95.0|1.19|85.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||85.64|1.19|0.0343
91771926|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4435|TWO_SIDED|95.0|0.49|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.09|0.49|0.4435
91519796|NCT01212770|182913607|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.8||||0.0295|TWO_SIDED|95.0|1.1|18.6|||Cochran-Mantel-Haenszel|2-sided p-value based on the Cochran-Mantel-Haenszel test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||18.6|1.1|0.0295
91519797|NCT01212770|182913608|SUPERIORITY||LS Mean Difference|-0.127||||0.0073|TWO_SIDED|95.0|-0.22|-0.034|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.034|-0.220|0.0073
91519798|NCT01212770|182913608|SUPERIORITY||LS Mean Difference|-0.066||||0.1619|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||0.027|-0.158|0.1619
91519799|NCT01212770|182913609|SUPERIORITY||Adjusted Difference|15.5||||0.0007|TWO_SIDED|95.0|6.7|24.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||24.3|6.7|0.0007
91519800|NCT01212770|182913609|SUPERIORITY||Adjusted Difference|11.1||||0.011|TWO_SIDED|95.0|2.7|19.5||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||19.5|2.7|0.0110
91519801|NCT01212770|182913610|SUPERIORITY||LS Mean Difference|-0.139||||0.005|TWO_SIDED|95.0|-0.236|-0.042|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.042|-0.236|0.0050
91519802|NCT01212770|182913610|SUPERIORITY||LS Mean Difference|-0.084||||0.086|TWO_SIDED|95.0|-0.181|0.012|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.012|-0.181|0.0860
91519803|NCT01212770|182913611|SUPERIORITY||LS Mean Difference|2.32||||0.0053|TWO_SIDED|95.0|0.69|3.95|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||3.95|0.69|0.0053
91519804|NCT01212770|182913611|SUPERIORITY||LS mean Difference|1.15||||0.1658|TWO_SIDED|95.0|-0.48|2.77|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||2.77|-0.48|0.1658
91519805|NCT01212770|182913612|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.4|||<|0.0001|TWO_SIDED|95.0|15.5|35.3|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||35.3|15.5|<0.0001
91519806|NCT01212770|182913612|SUPERIORITY||Adjusted Difference|10.4||||0.0372|TWO_SIDED|95.0|0.8|20.0|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||20.0|0.8|0.0372
91707699|NCT04227405|183308942|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.05
91519807|NCT01212770|182913613|SUPERIORITY||Adjusted Difference|14.6||||0.0062|TWO_SIDED|95.0|4.5|24.8|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||24.8|4.5|0.0062
91519808|NCT01212770|182913613|SUPERIORITY||Adjusted Difference|13.0||||0.0134|TWO_SIDED|95.0|3.0|23.1|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||23.1|3.0|0.0134
91519809|NCT01212770|182913614|SUPERIORITY||LS Mean Difference|-7.8||||0.0021|TWO_SIDED|95.0|-12.8|-2.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-2.9|-12.8|0.0021
91519810|NCT01212770|182913614|SUPERIORITY||LS Mean Difference|-3.6||||0.1482|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||1.3|-8.6|0.1482
91645564|NCT02494583|183183264|OTHER||Hazard Ratio (HR)|1.64||||1|TWO_SIDED|95.0|1.36|1.98||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.98|1.36|1.00000
91645565|NCT02494583|183183265|OTHER||Difference in LS Means|-0.16||||0.948|TWO_SIDED|95.0|-5.01|4.69||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||4.69|-5.01|0.948
91645566|NCT02494583|183183266|OTHER||Difference in LS Means|1.98||||0.368|TWO_SIDED|95.0|-2.34|6.31||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.31|-2.34|0.368
91645567|NCT02494583|183183267|OTHER||Difference in LS Means|2.35||||0.308|TWO_SIDED|95.0|-2.18|6.89||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.89|-2.18|0.308
91519811|NCT01212770|182913615|SUPERIORITY||LS Mean Difference|-0.2||||0.5349|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.0|0.5349
91519812|NCT01212770|182913615|SUPERIORITY||LS Mean Difference|0.1||||0.8231|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.9|-0.7|0.8231
91519813|NCT01212770|182913616|SUPERIORITY||LS Mean Difference|-0.8||||0.072|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.1|-1.7|0.0720
91519814|NCT01212770|182913616|SUPERIORITY||LS Mean Difference|-0.4||||0.3641|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.3|0.3641
91519815|NCT01212770|182913617|SUPERIORITY||LS Mean Difference|-4.94||||0.0001|TWO_SIDED|95.0|-7.34|-2.53|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.53|-7.34|0.0001
91519816|NCT01212770|182913617|SUPERIORITY||LS Mean Difference|-1.85||||0.1325|TWO_SIDED|95.0|-4.27|0.56|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.56|-4.27|0.1325
91771927|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1805|TWO_SIDED|95.0|0.67|8.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.13|0.67|0.1805
91771928|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0857|TWO_SIDED|95.0|0.84|14.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.95|0.84|0.0857
91771929|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0316|TWO_SIDED|95.0|1.23|89.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||89.63|1.23|0.0316
91771930|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3471|TWO_SIDED|95.0|0.52|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.27|0.52|0.3471
91771931|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|6.15||||0.0313|TWO_SIDED|95.0|1.18|32.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||32.09|1.18|0.0313
91771932|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|12.49||||0.0208|TWO_SIDED|95.0|1.47|106.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.3|1.47|0.0208
91771933|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8669|TWO_SIDED|95.0|0.31|3.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.97|0.31|0.8669
91771934|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6592|TWO_SIDED|95.0|0.37|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.89|0.37|0.6592
91519817|NCT01212770|182913618|SUPERIORITY||LS Mean Difference|-0.47||||0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.70|0.0001
91519818|NCT01212770|182913618|SUPERIORITY||LS Mean Difference|-0.27||||0.0237|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.04|-0.50|0.0237
91771935|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.23||||0.2923|TWO_SIDED|95.0|0.5|9.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.98|0.50|0.2923
91771936|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.78||||0.1145|TWO_SIDED|95.0|0.65|51.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||51.04|0.65|0.1145
91771937|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.77||||0.447|TWO_SIDED|95.0|0.4|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.40|0.4470
91771938|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|7.31||||0.0753|TWO_SIDED|95.0|0.82|65.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||65.41|0.82|0.0753
91771939|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|6.85||||0.0829|TWO_SIDED|95.0|0.78|60.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||60.24|0.78|0.0829
91771940|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9978|TWO_SIDED|95.0|0.28|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.59|0.28|0.9978
91771941|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.68||||0.4571|TWO_SIDED|95.0|0.43|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.65|0.43|0.4571
91771942|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.99||||0.3681|TWO_SIDED|95.0|0.44|8.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.94|0.44|0.3681
91645568|NCT02494583|183183268|OTHER||Difference in LS Means|-6.56||||0.001|TWO_SIDED|95.0|-10.55|-2.58||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||-2.58|-10.55|0.001
91645569|NCT02617446|183183317|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.029|TWO_SIDED|95.0|-5.68|-0.32||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.32|-5.68|0.029
91645570|NCT02617446|183183317|SUPERIORITY||Mean Difference (Final Values)|-2.08||||0.009|TWO_SIDED|95.0|-3.61|-0.55||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.55|-3.61|0.009
91645571|NCT02617446|183183318|SUPERIORITY||Mean Difference (Final Values)|1.7632||||0.089|TWO_SIDED|95.0|-0.2751|3.8014||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.8014|-0.2751|0.089
91645572|NCT02617446|183183318|SUPERIORITY||Mean Difference (Final Values)|0.9848||||0.423|TWO_SIDED|95.0|-1.4668|3.4365||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.4365|-1.4668|0.423
91645573|NCT02617446|183183319|SUPERIORITY||Mean Difference (Final Values)|3.684||||0.034|TWO_SIDED|95.0|0.285|7.083||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in SVI between istaroxime and placebo participants.||7.083|0.285|0.034
91645574|NCT02617446|183183319|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.09|TWO_SIDED|95.0|-0.373|4.992||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.992|-0.373|0.090
91645575|NCT02617446|183183320|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.042|TWO_SIDED|95.0|-1.522|-0.032||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is included in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.032|-1.522|0.042
91645576|NCT02617446|183183320|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.029|TWO_SIDED|95.0|-1.568|-0.091||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.091|-1.568|0.029
91645577|NCT02617446|183183321|SUPERIORITY||Mean Difference (Final Values)|-5.368||||0.11|TWO_SIDED|95.0|-11.999|1.262||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVESV between istaroxime and placebo participants.||1.262|-11.999|0.110
91645578|NCT02617446|183183321|SUPERIORITY||Mean Difference (Final Values)|0.439||||0.931|TWO_SIDED|95.0|-9.735|10.614||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVEDV between istaroxime and placebo participants.||10.614|-9.735|0.931
91645579|NCT02617446|183183322|SUPERIORITY||Mean Difference (Final Values)|-1.657||||0.589|TWO_SIDED|95.0|-7.777|4.461||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.461|-7.777|0.589
91645580|NCT02617446|183183322|SUPERIORITY||Mean Difference (Final Values)|3.944||||0.424|TWO_SIDED|95.0|-5.886|13.774||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||13.774|-5.886|0.424
91645581|NCT02617446|183183323|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|-0.041||||0.987|TWO_SIDED|95.0|-5.216|5.133||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups||5.133|-5.216|0.987
91645582|NCT02617446|183183323|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|3.015||||0.251|TWO_SIDED|95.0|-2.168|8.198||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups.||8.198|-2.168|0.251
91645583|NCT00644228|183183375|SUPERIORITY||Hazard Ratio (HR)|0.712||||0.0018|TWO_SIDED|96.0|0.56|0.906||The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.||0.906|0.560|0.0018
91707700|NCT04227405|183308942|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.01
91707701|NCT04227405|183308942|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
91707702|NCT04227405|183308942|SUPERIORITY||Slope|0.59|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
91645584|NCT00644228|183183376|SUPERIORITY||Hazard Ratio (HR)|0.709||||0.025|TWO_SIDED|95.0|0.524|0.959||The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|Overall survival will be compared between the two treatment arms using a stratified log-rank test.||0.959|0.524|0.0250
91645585|NCT00644228|183183377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Cochran-Mantel-Haenszel|||||||0.20
91645586|NCT00417859|183183424|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.||||0.05
91645587|NCT04223193|183183479|SUPERIORITY||LS Mean of Difference|-9.1|STANDARD_ERROR_OF_MEAN|1.31|<|0.0001|TWO_SIDED|95.0|-11.7|-6.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-6.5|-11.7|<0.0001
91645588|NCT04223193|183183480|SUPERIORITY||LS Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44||0.0007|TWO_SIDED|95.0|-2.4|-0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-0.6|-2.4|0.0007
91645589|NCT04223193|183183481|SUPERIORITY||Odds Ratio (OR)|3.942|||<|0.0001|TWO_SIDED|95.0|2.209|7.037|||Mixed Models Analysis|||||7.037|2.209|<0.0001
91645590|NCT04223193|183183482|SUPERIORITY||LS Mean of Difference|-9.1|STANDARD_ERROR_OF_MEAN|1.31|<|0.0001|TWO_SIDED|95.0|-11.7|-6.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-6.5|-11.7|<0.0001
91645591|NCT04223193|183183483|SUPERIORITY||LS Mean of Difference|-8.3|STANDARD_ERROR_OF_MEAN|1.52|<|0.0001|TWO_SIDED|95.0|-11.3|-5.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-5.3|-11.3|<0.0001
91645592|NCT04223193|183183484|SUPERIORITY||LS Mean of Difference|0.7|STANDARD_ERROR_OF_MEAN|0.42||0.0766|TWO_SIDED|95.0|-0.1|1.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||1.6|-0.1|0.0766
91645593|NCT04223193|183183484|SUPERIORITY||LS Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44||0.0007|TWO_SIDED|95.0|-2.4|-0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-0.6|-2.4|0.0007
91645594|NCT04223193|183183484|SUPERIORITY||LS Mean of Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-9.7|-5.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-5.6|-9.7|<0.0001
91645595|NCT04223193|183183485|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.5|-0.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Wek 26||-0.2|-0.5|<0.0001
91645596|NCT04223193|183183486|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.3|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.3|<0.0001
91771943|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|6.12||||0.1038|TWO_SIDED|95.0|0.69|54.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||54.38|0.69|0.1038
91645597|NCT04223193|183183487|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.3|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.3|<0.0001
91645598|NCT04223193|183183488|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9795|TWO_SIDED|95.0|-0.6|0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.6|-0.6|0.9795
91645599|NCT04223193|183183489|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.45||0.8916|TWO_SIDED|95.0|-0.9|0.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.8|-0.9|0.8916
91645600|NCT03594175|183183492|SUPERIORITY||Mean difference of proportions, Wald|29.51||||0.003|TWO_SIDED|95.0|10.76|48.26|||2-sample Z test for proportions|||CUSA-081 vs Placebo Dwell Time Up To 90 Min -- FAS||48.26|10.76|0.003
91645601|NCT03594175|183183493|NON_INFERIORITY|Non-inferiority was assessed based on the constructed 95% confidence interval (CI) for the difference in the rate of treatment success between CUSA-081 vs alteplase, with non-inferiority considered as demonstrated if the lower limit of the 95% CI for the difference in rate of success is greater than -10%.|Mean difference of proportions, Wald|-10.31||||0.03|TWO_SIDED|95.0|-19.38|-1.24|||2-sample Z test for proportions|||||-1.24|-19.38|0.030
91645602|NCT03594175|183183494|SUPERIORITY||Mean difference of proportions, Wald|24.13||||0.017|TWO_SIDED|95.0|5.84|42.41|||2-sample Z test for proportions|||||42.41|5.84|0.017
91645603|NCT03594175|183183495|SUPERIORITY||Mean difference of proportions, Wald|41.08|||<|0.001|TWO_SIDED|95.0|21.94|60.21|||2-sample Z test for proportions|||||60.21|21.94|<0.001
91645604|NCT03594175|183183496|SUPERIORITY||Mean difference of proportions, Wald|-10.96||||0.019|TWO_SIDED|95.0|-19.89|-2.04|||2-sample Z test for proportions|||||-2.04|-19.89|0.019
91645605|NCT03594175|183183497|SUPERIORITY||Probability Re-Occlusion Free at Day 30|0.948|||||TWO_SIDED|95.0|0.126|7.121||||||Time to first re-occlusion.||7.121|0.126|
91645606|NCT03594175|183183497|OTHER||Cox Proportional Hazard|0.654|||||TWO_SIDED|95.0|0.337|1.27||||||Time to first re-occlusion.||1.270|0.337|
91645607|NCT03594175|183183497|OTHER||Cox Proportional Hazard|1.448|||||TWO_SIDED|95.0|0.193|10.848||||||Time to first re-occlusion.||10.848|0.193|
91645608|NCT03732677|183183500|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0005|TWO_SIDED|95.0|1.227|2.084|||Regression, Logistic|Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .||||2.084|1.227|0.0005
91645609|NCT03732677|183183501|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.877|0.554|824.0||Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)||95% CI for hazard ratio: 0.558 - 0.817|0824|0.554|<0.0001
91645610|NCT03732677|183183502|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0021|TWO_SIDED|95.0|0.62|0.9|||Chi-squared|P-value is based on a chi-squared test with one degree of freedom.|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.90|0.62|0.0021
91645611|NCT03732677|183183503|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0265|TWO_SIDED|95.0|1.047|2.095|||Regression, Logistic|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Strata adjusted odds ratio by the logistic regression method. Stratified by adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative).|||2.095|1.047|0.0265
91645612|NCT03732677|183183504|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0106|TWO_SIDED|98.457|0.563|0.985|||Log Rank|Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)|||95% CI: 0.594 to 0.934|0.985|0.563|0.0106
91645613|NCT03732677|183183505|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0002|TWO_SIDED|95.0|0.541|0.826|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.826|0.541|0.0002
91645614|NCT03732677|183183506|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0081|TWO_SIDED|95.0|0.516|0.907|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.907|0.516|0.0081
91645615|NCT01500434|183183546|NON_INFERIORITY_OR_EQUIVALENCE|Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.|Target Lesion Failure Rate|3.2|||<|0.0001|ONE_SIDED|95.0||7.96|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.||7.96||<0.0001
91645616|NCT03353415|183183679|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91645617|NCT03353415|183183680|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91645618|NCT03353415|183183681|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91645619|NCT03353415|183183682|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
91645620|NCT03353415|183183683|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
91645621|NCT03353415|183183684|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91645622|NCT03353415|183183685|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91645623|NCT03353415|183183686|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91645624|NCT03353415|183183687|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91645625|NCT03353415|183183688|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91645626|NCT03353415|183183689|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91645627|NCT03353415|183183690|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
91645628|NCT03353415|183183691|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91645629|NCT03353415|183183692|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91645630|NCT03353415|183183693|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91645631|NCT03353415|183183694|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91645632|NCT03353415|183183695|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91645633|NCT03353415|183183696|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91645634|NCT03353415|183183697|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91645635|NCT03353415|183183698|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91645636|NCT03353415|183183699|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91645637|NCT04647253|183183715|SUPERIORITY||Rate difference between treatment groups|-10.8||||0.0025|TWO_SIDED|95.0|-18.4|-3.3||a priori threshold for statistical significance was 0.025|z-test with unpooled variance|||||-3.3|-18.4|0.0025
91519819|NCT01212770|182913619|SUPERIORITY||LS Mean Difference|2.54||||0.0049|TWO_SIDED|95.0|0.77|4.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.30|0.77|0.0049
91519820|NCT01212770|182913619|SUPERIORITY||LS Mean Difference|0.68||||0.4505|TWO_SIDED|95.0|-1.09|2.44|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.44|-1.09|0.4505
91519821|NCT01212770|182913620|SUPERIORITY||LS Mean Difference|2.34||||0.0043|TWO_SIDED|95.0|0.74|3.94|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.94|0.74|0.0043
91519822|NCT01212770|182913620|SUPERIORITY||LS Mean Difference|1.67||||0.0404|TWO_SIDED|95.0|0.07|3.27|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.27|0.07|0.0404
91519823|NCT01212770|182913621|SUPERIORITY||Adjusted Difference|21.2|||<|0.0001|TWO_SIDED|95.0|11.5|30.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||30.9|11.5|< 0.0001
91519824|NCT01212770|182913621|SUPERIORITY||Adjusted Difference|8.7||||0.0661|TWO_SIDED|95.0|-0.5|18.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||18.0|-0.5|0.0661
91519825|NCT01212770|182913622|SUPERIORITY||Adjusted Difference|14.8||||0.0099|TWO_SIDED|95.0|3.8|25.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.7|3.8|0.0099
91519826|NCT01212770|182913622|SUPERIORITY||Adjusted Difference|10.8||||0.0515|TWO_SIDED|95.0|0.1|21.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.4|0.1|0.0515
91519827|NCT01212770|182913623|SUPERIORITY||LS mean Difference|-6.6||||0.008|TWO_SIDED|95.0|-11.4|-1.7|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-1.7|-11.4|0.0080
91519828|NCT01212770|182913623|SUPERIORITY||LS Mean Difference|-3.8||||0.1218|TWO_SIDED|95.0|-8.6|1.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||1.0|-8.6|0.1218
91519829|NCT01212770|182913624|SUPERIORITY||LS Mean Difference|-0.4||||0.2761|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.4|-1.3|0.2761
91519830|NCT01212770|182913624|SUPERIORITY||LS Mean Difference|-0.3||||0.5012|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.1|0.5012
91519831|NCT01212770|182913625|SUPERIORITY||LS Mean Difference|-1.0||||0.0399|TWO_SIDED|95.0|-1.9|0.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.0|-1.9|0.0399
91519832|NCT01212770|182913625|SUPERIORITY||LS Mean Difference|-0.4||||0.4413|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.3|0.4413
91519833|NCT01212770|182913626|SUPERIORITY||LS Mean Difference|-5.27|||<|0.0001|TWO_SIDED|95.0|-7.73|-2.82|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.82|-7.73|< 0.0001
91771944|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4639|TWO_SIDED|95.0|0.39|7.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.72|0.39|0.4639
91519834|NCT01212770|182913626|SUPERIORITY||LS Mean Difference|-2.65||||0.0349|TWO_SIDED|95.0|-5.11|-0.19|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.19|-5.11|0.0349
91519835|NCT01212770|182913627|SUPERIORITY||LS Mean Difference|-0.48||||0.0001|TWO_SIDED|95.0|-0.72|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.72|0.0001
91519836|NCT01212770|182913627|SUPERIORITY||LS Mean Difference|-0.3||||0.0147|TWO_SIDED|95.0|-0.54|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.06|-0.54|0.0147
91519837|NCT01212770|182913628|SUPERIORITY||LS Mean Difference|2.44||||0.0078|TWO_SIDED|95.0|0.64|4.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.24|0.64|0.0078
91519838|NCT01212770|182913628|SUPERIORITY||LS Mean Difference|1.19||||0.1936|TWO_SIDED|95.0|-0.61|2.98|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.98|-0.61|0.1936
91645638|NCT01209234|183183716|SUPERIORITY||Cox Proportional Hazard|0.7|STANDARD_ERROR_OF_MEAN|0.024||0.026|TWO_SIDED|95.0|0.52|0.96|||Regression, Cox||This is the estimated standard error of the log hazard ratio|||0.96|0.52|0.026
91519839|NCT01212770|182913629|SUPERIORITY||Adjusted Difference|2.1||||0.7585|TWO_SIDED|95.0|-10.9|15.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.0|-10.9|0.7585
91519840|NCT01212770|182913629|SUPERIORITY||Adjusted Difference|-3.9||||0.5808|TWO_SIDED|95.0|-17.4|9.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||9.7|-17.4|0.5808
91519841|NCT01212770|182913630|SUPERIORITY||Adjusted Difference|12.0||||0.1303|TWO_SIDED|95.0|-3.1|27.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD useinvolvement of \>= 3% BSA with psoriasis at baseline..|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||27.0|-3.1|0.1303
91519842|NCT01212770|182913630|SUPERIORITY||Adjusted Difference|7.5||||0.361|TWO_SIDED|95.0|-8.3|23.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||23.2|-8.3|0.3610
91519843|NCT01212770|182913631|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|12.4|32.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.6|12.4|< 0.0001
91519844|NCT01212770|182913631|SUPERIORITY||Adjusted Difference|11.0||||0.0309|TWO_SIDED|95.0|1.2|20.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.9|1.2|0.0309
91645639|NCT01209234|183183717|SUPERIORITY||Cox Proportional Hazard|0.84|STANDARD_ERROR_OF_MEAN|0.009||0.061|TWO_SIDED|95.0|0.7|1.01||Not adjusted for multiple comparisons|Regression, Cox||CDC-defined all-cause infection secondary outcome This is the estimated standard error of the log hazard ratio|||1.01|0.70|0.061
91645640|NCT01209234|183183717|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.008||0.035|TWO_SIDED|95.0|0.7|0.99||Not adjusted for multiple comparisons|Regression, Cox||Clinical criteria for all-cause infection This is the estimated standard error of the log hazard ratio|||0.99|0.70|0.035
91707703|NCT04227405|183308942|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.001
91519845|NCT01212770|182913632|SUPERIORITY||Adjusted Difference|3.8||||0.5731|TWO_SIDED|95.0|-9.1|16.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||16.7|-9.1|0.5731
91519846|NCT01212770|182913632|SUPERIORITY||Adjusted Difference|1.0||||0.8876|TWO_SIDED|95.0|-12.6|14.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||14.6|-12.6|0.8876
91519847|NCT01212770|182913633|SUPERIORITY||Adjusted Difference|12.2||||0.1172|TWO_SIDED|95.0|-2.5|26.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||26.9|-2.5|0.1172
91519848|NCT01212770|182913633|SUPERIORITY||Adjusted Difference|7.2||||0.3695|TWO_SIDED|95.0|-8.2|22.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||22.6|-8.2|0.3695
91707704|NCT04227405|183308942|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
91707705|NCT04227405|183308942|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the Intervention group||||>.05
91707706|NCT04227405|183308942|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||>.05
91645641|NCT04502862|183183722|OTHER||Least square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.107||0.512|TWO_SIDED|95.0|-0.28|0.14||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, body mass index (BMI), region (Eastern Europe, rest of world \[ROW\]), inhaled corticosteroids \[ICS\] dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline asthma control questionnaire (ACQ-5), baseline sleep disturbance score and baseline-by-visit interaction as covariates.||0.14|-0.28|0.512
91645642|NCT04502862|183183723|OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.967|TWO_SIDED|95.0|-0.21|0.22||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline number of nocturnal awakenings and baseline-by-visit interaction as covariates.||0.22|-0.21|0.967
91645643|NCT04502862|183183724|OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.865||0.422|TWO_SIDED|95.0|-2.4|1.01||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline PROMIS total score and baseline-by-visit interaction as covariates.||1.01|-2.40|0.422
91645644|NCT02038959|183183735|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
91645645|NCT02038959|183183740|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91645646|NCT00819091|183183767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.7|-0.24|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-0.24|-0.70|< 0.0001
91645647|NCT00819091|183183768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.5||0.2406||95.0|-17.2|4.3|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||4.3|-17.2|0.2406
91645648|NCT00819091|183183769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.466||||0.0065||95.0|1.684|24.825|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||24.825|1.684|0.0065
91645649|NCT00819091|183183770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.2431||95.0|0.515|13.652|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||13.652|0.515|0.2431
91645650|NCT00819091|183183771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.125||||0.0001||95.0|2.747|9.562|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||9.562|2.747|0.0001
91645651|NCT00819091|183183772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||<|0.0001||95.0|-0.585|-0.23|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.230|-0.585|<0.0001
91645652|NCT00819091|183183773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.0001||95.0|-0.72|-0.276|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.276|-0.720|<0.0001
91645653|NCT00819091|183183774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.0002||95.0|-0.716|-0.226|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.226|-0.716|0.0002
91645654|NCT00819091|183183775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|4.6||0.197||95.0|-14.9|3.1|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||3.1|-14.9|0.197
91645655|NCT00819091|183183776|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|5.6||0.0105||95.0|-25.5|-3.4|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-3.4|-25.5|0.0105
91645656|NCT00545441|183183777|NON_INFERIORITY_OR_EQUIVALENCE|Alpha = 0.05 and power = 0.8, a non-inferiority margin of 10%.||||||0.59|TWO_SIDED||||||Fisher Exact|||||||0.59
91645657|NCT04071366|183183790|SUPERIORITY||Difference in CRS rate|-0.39||||0.003|TWO_SIDED|95.0|-0.6463|-0.1363|||One-sided Z-test|||||-0.1363|-0.6463|0.0030
91771945|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|7.15||||0.077|TWO_SIDED|95.0|0.81|63.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||63.27|0.81|0.0770
91645658|NCT04071366|183183790|OTHER||Difference in CRS rate|-0.37|||||TWO_SIDED|95.0|-0.6073|-0.1231||||||||-0.1231|-0.6073|
91645659|NCT04071366|183183790|OTHER||Difference in CRS rate|0.03|||||TWO_SIDED|95.0|-0.1778|0.2299||||||||0.2299|-0.1778|
91645660|NCT01336608|183183808|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01||||0.969|TWO_SIDED|95.0|-0.71|0.74|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.74|-0.71|0.969
91645661|NCT01336608|183183808|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22||||0.568|TWO_SIDED|95.0|-0.53|0.96|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.96|-0.53|0.568
91645662|NCT01336608|183183808|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.2||||0.566|TWO_SIDED|95.0|-0.49|0.89|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.89|-0.49|0.566
91645663|NCT01336608|183183809|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.007|TWO_SIDED|95.0|0.023|0.141||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.141|0.023|0.007
91645664|NCT01336608|183183809|SUPERIORITY_OR_OTHER||Least squares mean difference|0.155|||<|0.001|TWO_SIDED|95.0|0.095|0.215||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.215|0.095|<0.001
91645665|NCT01336608|183183809|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.012|TWO_SIDED|95.0|0.016|0.131||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.131|0.016|0.012
91645666|NCT01336608|183183810|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22||Nominal p-value|ANCOVA|||||-0.22|-0.72|<0.001
91645667|NCT01336608|183183810|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.76|-0.24||Nominal p-value|ANCOVA|||||-0.24|-0.76|<0.001
91645668|NCT01336608|183183810|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03||||0.803|TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||||0.22|-0.29|0.803
91645669|NCT02437890|183183825|SUPERIORITY||||||=|0.526||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: linear model"||||= 0.526
91645670|NCT02437890|183183825|SUPERIORITY||||||=|0.504||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: Emax model"||||= 0.504
91645671|NCT02437890|183183825|SUPERIORITY||||||=|0.548||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: logistic model"||||= 0.548
91645672|NCT02437890|183183825|SUPERIORITY||||||=|0.985||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 1st Beta model"||||= 0.985
91645673|NCT02437890|183183825|SUPERIORITY||||||=|0.524||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 2nd Beta model"||||= 0.524
91645674|NCT04604496|183183922|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|133.17|||||TWO_SIDED|90.0|81.97|216.37||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||216.37|81.97|
91771946|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9838|TWO_SIDED|95.0|0.26|4.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.01|0.26|0.9838
91645675|NCT04604496|183183922|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|219.98|||||TWO_SIDED|90.0|135.39|357.41||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||357.41|135.39|
91645676|NCT04604496|183183922|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|334.21|||||TWO_SIDED|90.0|205.7|543.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||543.00|205.70|
91645677|NCT04604496|183183923|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.7|||||TWO_SIDED|90.0|61.33|245.49||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.49|61.33|
91645678|NCT04604496|183183923|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|282.73|||||TWO_SIDED|90.0|141.32|565.66||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||565.66|141.32|
91645679|NCT04604496|183183923|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|640.78|||||TWO_SIDED|90.0|320.27|1282.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1282.00|320.27|
91645680|NCT04604496|183183924|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.89|||||TWO_SIDED|90.0|61.51|245.51||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.51|61.51|
91645681|NCT04604496|183183924|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|283.88|||||TWO_SIDED|90.0|142.1|567.13||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||567.13|142.10|
91645682|NCT04604496|183183924|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|636.32|||||TWO_SIDED|90.0|318.51|1271.24||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1271.24|318.51|
91519849|NCT01212770|182913634|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|13.0|32.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.1|13.0|< 0.0001
91519850|NCT01212770|182913634|SUPERIORITY||Adjusted Difference|11.7||||0.0123|TWO_SIDED|95.0|2.7|20.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.7|2.7|0.0123
91519851|NCT01212770|182913635|SUPERIORITY||Adjusted Difference|6.8||||0.052|TWO_SIDED|95.0|0.0|13.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||13.5|0.0|0.0520
91519852|NCT01212770|182913635|SUPERIORITY||Adjusted Difference|4.2||||0.2052|TWO_SIDED|95.0|-2.2|10.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||10.6|-2.2|0.2052
91519853|NCT01212770|182913636|SUPERIORITY||Adjusted Difference|1.2||||0.5154|TWO_SIDED|95.0|-2.4|4.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.8|-2.4|0.5154
91519854|NCT01212770|182913636|SUPERIORITY||Adjusted Difference|2.3||||0.2527|TWO_SIDED|95.0|-1.5|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-1.5|0.2527
91519855|NCT01212770|182913637|SUPERIORITY||Adjusted Difference|8.3||||0.018|TWO_SIDED|95.0|1.6|15.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.1|1.6|0.0180
91519856|NCT01212770|182913637|SUPERIORITY||Adjusted Difference|5.8||||0.0807|TWO_SIDED|95.0|-0.6|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||12.3|-0.6|0.0807
91519857|NCT01212770|182913638|SUPERIORITY||Adjusted Difference|1.8||||0.423|TWO_SIDED|95.0|-2.6|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-2.6|0.4230
91519858|NCT01212770|182913638|SUPERIORITY||Adjusted Difference|0.6||||0.787|TWO_SIDED|95.0|-3.5|4.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.6|-3.5|0.7870
91519859|NCT01212770|182913639|SUPERIORITY||Adjusted Difference|-4.1||||0.4707|TWO_SIDED|95.0|-14.8|6.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.5|-14.8|0.4707
91519860|NCT01212770|182913639|SUPERIORITY||Adjusted Difference|-5.4||||0.3547|TWO_SIDED|95.0|-16.6|5.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||5.7|-16.6|0.3547
91519861|NCT01212770|182913640|SUPERIORITY||Adjusted Difference|6.6||||0.4175|TWO_SIDED|95.0|-8.6|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-8.6|0.4175
91645683|NCT04604496|183183925|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|85.19|||||TWO_SIDED|90.0|63.6|114.1||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||114.10|63.60|
91645684|NCT04604496|183183925|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|96.37|||||TWO_SIDED|90.0|71.95|129.07||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||129.07|71.95|
91645685|NCT04604496|183183925|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|135.2|||||TWO_SIDED|90.0|100.94|181.1||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||181.10|100.94|
91645686|NCT02533505|183183930|SUPERIORITY||Mean Difference (Final Values)|10.114||||0.007|TWO_SIDED|95.0|2.943|17.286||All p-values ≤ 0.05 after rounding will be considered statistically significant.|Mixed Models Analysis|||||17.286|2.943|0.007
91645687|NCT02533505|183183931|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.111|TWO_SIDED|95.0|-0.021|0.196|||Mixed Models Analysis|||||0.196|-0.021|0.111
91645688|NCT02533505|183183932|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.609|TWO_SIDED|95.0|-1.018|1.719|||Mixed Models Analysis|||ΔHR||1.719|-1.018|0.609
91645689|NCT02533505|183183933|SUPERIORITY||Mean Difference (Final Values)|0.191|||<|0.001|TWO_SIDED|95.0|0.15|0.233|||Mixed Models Analysis|||ΔFEV1||0.233|0.150|<0.001
91645690|NCT02533505|183183933|SUPERIORITY||Mean Difference (Final Values)|0.312|||<|0.001|TWO_SIDED|95.0|0.236|0.388|||Mixed Models Analysis|||ΔFVC||0.388|0.236|<0.001
91645691|NCT02533505|183183933|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.218|0.342|||Mixed Models Analysis|||ΔIC||0.342|0.218|<0.001
91645692|NCT02533505|183183934|SUPERIORITY||Mean Difference (Final Values)|23.315||||0.021|TWO_SIDED|95.0|3.723|42.907|||Mixed Models Analysis|||ΔVT/Ti||42.907|3.723|0.021
91645693|NCT02533505|183183935|SUPERIORITY||Mean Difference (Final Values)|-0.204||||0.106|TWO_SIDED|95.0|-0.454|0.045|||Mixed Models Analysis|||||0.045|-0.454|0.106
91645694|NCT02533505|183183936|SUPERIORITY||Mean Difference (Final Values)|10.245||||0.011|TWO_SIDED|95.0|2.469|18.021|||Mixed Models Analysis|||ΔVCO2||18.021|2.469|0.011
91645695|NCT02533505|183183937|SUPERIORITY||Mean Difference (Final Values)|0.242||||0.333|TWO_SIDED|95.0|-0.255|0.738|||Mixed Models Analysis|||ΔSaO2||0.738|-0.255|0.333
91645696|NCT02533505|183183938|SUPERIORITY||Mean Difference (Final Values)|0.237||||0.484|TWO_SIDED|95.0|-0.439|0.913|||Mixed Models Analysis|||ΔRR||0.913|-0.439|0.484
91645697|NCT02533505|183183939|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.113|TWO_SIDED|95.0|-0.004|0.036|||Mixed Models Analysis|||ΔTi/Ttot||0.036|-0.004|0.113
91645698|NCT02533505|183183940|SUPERIORITY||Mean Difference (Final Values)|57.624|||<|0.001|TWO_SIDED|95.0|29.701|85.546|||Mixed Models Analysis|||ΔVt||85.546|29.701|<0.001
91645699|NCT02533505|183183941|SUPERIORITY||Mean Difference (Final Values)|862.157|||<|0.001|TWO_SIDED|95.0|439.817|1284.496|||Mixed Models Analysis|||ΔVe||1284.496|439.817|<0.001
91645700|NCT02533505|183183942|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.007|TWO_SIDED|95.0|0.005|0.033|||Mixed Models Analysis|||ΔFEV1/FVC||0.033|0.005|0.007
91645701|NCT02609178|183183958|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.003||||||Alpha value was set at 0.05.|ANOVA|||||||0.003
91645702|NCT02609178|183183958|NON_INFERIORITY_OR_EQUIVALENCE|stated above in statistical analysis 1||||||0.366||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.366
91645703|NCT02609178|183183958|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.002
91645704|NCT02609178|183183958|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.054||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.054
91645705|NCT02609178|183183959|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.006||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.006
91645706|NCT02609178|183183959|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistic analysis 1.||||||0.739||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.739
91645707|NCT02609178|183183959|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.03||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.03
91645708|NCT02609178|183183959|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.009||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.009
91645709|NCT02609178|183183960|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.001||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.001
91645710|NCT02609178|183183960|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.579||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.579
91645711|NCT02609178|183183960|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.001||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.001
91645712|NCT02609178|183183960|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.002
91645713|NCT02609178|183183961|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.007||||||alpha value was set at 0.05|ANOVA|||||||0.007
91645714|NCT02609178|183183961|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.308||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.308
91645715|NCT02609178|183183961|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.005||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.005
91645716|NCT02609178|183183961|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.141||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.141
91645717|NCT03583931|183183963|SUPERIORITY|||||||0.61|||||||ANOVA|||||||0.61
91645718|NCT03583931|183183964|SUPERIORITY|||||||0.84|||||||ANOVA|||||||0.84
91645719|NCT03583931|183183969|SUPERIORITY|||||||0.48|||||||ANOVA|||||||0.48
91645720|NCT03583931|183183970|SUPERIORITY|||||||0.25|||||||ANOVA|||||||0.25
91645721|NCT03583931|183183971|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.45
91645722|NCT03583931|183183972|SUPERIORITY|||||||0.87|||||||ANOVA|||||||0.87
91645723|NCT05016765|183183989|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
91707707|NCT04227405|183308942|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
91771947|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6995|TWO_SIDED|95.0|0.21|2.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.86|0.21|0.6995
91771948|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8808|TWO_SIDED|95.0|0.26|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.71|0.26|0.8808
91771949|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|4.94||||0.157|TWO_SIDED|95.0|0.54|45.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||45.13|0.54|0.1570
91771950|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.19||||0.3742|TWO_SIDED|95.0|0.39|12.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.26|0.39|0.3742
91771951|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.24||||0.1436|TWO_SIDED|95.0|0.57|48.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||48.26|0.57|0.1436
91771952|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.57||||0.1277|TWO_SIDED|95.0|0.61|50.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||50.77|0.61|0.1277
91771953|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6689|TWO_SIDED|95.0|0.2|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.81|0.20|0.6689
91519862|NCT01212770|182913640|SUPERIORITY||Adjusted Difference|6.4||||0.437|TWO_SIDED|95.0|-9.1|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-9.1|0.4370
91519863|NCT01212770|182913641|SUPERIORITY||Adjusted Difference|-0.4||||0.9463|TWO_SIDED|195.0|-12.1|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||11.3|-12.1|0.9463
91771954|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.2||||0.8019|TWO_SIDED|95.0|0.29|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.29|0.8019
91771955|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9591|TWO_SIDED|95.0|0.23|4.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.05|0.23|0.9591
91771956|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.33||||0.3364|TWO_SIDED|95.0|0.42|13.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.06|0.42|0.3364
91771957|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3698|TWO_SIDED|95.0|0.39|12.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.32|0.39|0.3698
91771958|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1587|TWO_SIDED|95.0|0.54|45.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.01|0.54|0.1587
91771959|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.61|50.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.06|0.61|0.1300
91771960|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.81||||0.4152|TWO_SIDED|95.0|0.43|7.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.53|0.43|0.4152
91771961|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9645|TWO_SIDED|95.0|0.27|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.50|0.27|0.9645
91771962|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3884|TWO_SIDED|95.0|0.43|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.96|0.43|0.3884
91645724|NCT05016765|183183989|OTHER|Pearson correlation test|Pearson's R|0.21||||0.33|TWO_SIDED|95.0|-0.22|0.56|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic frequency with stimulation during this study) with the change in tic frequency (measured as the number of 10-second tic-free intervals) during active, rhythmic stimulation in the randomized, controlled trial of MNS that all participants had previously completed.||0.56|-0.22|0.33
91645725|NCT05016765|183183990|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Paired Samples Wilcoxon Test||||||<0.001
91645726|NCT05016765|183183990|OTHER|Pearson's R|Pearson's R|0.36||||0.08|TWO_SIDED|95.0|-0.05|0.66|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic intensity during this study) with change in tic intensity during active, rhythmic stimulation during the randomized, controlled trial that all participants had previously completed.||0.66|-0.05|0.08
91645727|NCT05016765|183183995|OTHER|Traditional comparative||||||0.84|||||||Paired Sample t-Test, 2-Sided|||||||0.84
91645728|NCT00068770|183183997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|1.0||0.82|TWO_SIDED|95.0|1.5|5.5||not adjusted|t-test, 2 sided|||two independent group comparisons||5.5|1.5|0.82
91645729|NCT00068770|183183998|NON_INFERIORITY_OR_EQUIVALENCE|equivalence analysis|Hazard Ratio (HR)|2.7|STANDARD_DEVIATION|1.8||0.11|TWO_SIDED|95.0|1.1|6.3|||Log Rank|||||6.3|1.1|0.11
91645730|NCT02328404|183184015|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Fisher Exact test was used||The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\</= 0.05)||||0.001
91645731|NCT02328404|183184016|SUPERIORITY_OR_OTHER||||||<|0||||||A P-value \< 0.05 would be considered statistically significant.|t-test, 2 sided|||Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points||||<0.000
91645732|NCT02328404|183184017|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
91645733|NCT02328404|183184018|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.51
91645734|NCT02328404|183184019|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
91645735|NCT02328404|183184020|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
91645736|NCT02328404|183184021|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
91645737|NCT02328404|183184022|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
91645738|NCT02328404|183184023|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
91645739|NCT02328404|183184024|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
91645740|NCT02328404|183184025|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
91645741|NCT02328404|183184026|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
91645742|NCT02328404|183184027|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
91771963|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.62||||0.267|TWO_SIDED|95.0|0.48|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.41|0.48|0.2670
91645743|NCT02328404|183184028|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91645744|NCT02328404|183184029|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
91645745|NCT00285012|183184046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.4|||<|0.0001||95.0|4.99|14.14||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Primary endpoint was based on a CO confirmed 4-week CQR (weeks 4 through 12 inclusive). Intent was to evaluate the alternative hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment in subjects with mild to moderate COPD.||14.14|4.99|<0.0001
91645746|NCT00285012|183184047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001||95.0|2.75|8.65||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline versus (vs) placebo at Week 24||8.65|2.75|<0.0001
91645747|NCT00285012|183184047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04|||<|0.0001||95.0|2.13|7.67||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.67|2.13|<0.0001
91645748|NCT00285012|183184048|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.17|||<|0.0001||95.0|2.96|9.02||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||9.02|2.96|<0.0001
91645749|NCT00285012|183184048|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001||95.0|2.18|7.07||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.07|2.18|<0.0001
91645750|NCT00285012|183184049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|||<|0.0001||95.0|4.39|11.11||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 12||11.11|4.39|<0.0001
91645751|NCT00285012|183184049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001||95.0|1.79|4.54|||Regression, Logistic|p-value obtained from a logistic regression model including the main effects of treatment and pooled center|odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||4.54|1.79|<0.0001
91771964|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|6.91||||0.0861|TWO_SIDED|95.0|0.76|62.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||62.90|0.76|0.0861
91771965|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|7.21||||0.0774|TWO_SIDED|95.0|0.8|64.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||64.66|0.80|0.0774
91771966|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|4.73||||0.0389|TWO_SIDED|95.0|1.08|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.65|1.08|0.0389
91771967|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3695|TWO_SIDED|95.0|0.5|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.57|0.50|0.3695
91771968|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3501|TWO_SIDED|95.0|0.48|7.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.89|0.48|0.3501
91771969|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.49||||0.2021|TWO_SIDED|95.0|0.61|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.14|0.61|0.2021
91771970|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6201|TWO_SIDED|95.0|0.36|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.62|0.36|0.6201
91771971|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|13.71||||0.0235|TWO_SIDED|95.0|1.42|132.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||132.0|1.42|0.0235
91771972|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0929|TWO_SIDED|95.0|0.81|14.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.48|0.81|0.0929
91771973|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.99||||0.982|TWO_SIDED|95.0|0.29|3.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.33|0.29|0.9820
91771974|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4956|TWO_SIDED|95.0|0.44|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.41|0.44|0.4956
91771975|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5708|TWO_SIDED|95.0|0.2|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.20|0.5708
91771976|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1985|TWO_SIDED|95.0|0.61|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.61|0.61|0.1985
91771977|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8368|TWO_SIDED|95.0|0.31|4.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.32|0.31|0.8368
91771978|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|3.18||||0.1397|TWO_SIDED|95.0|0.68|14.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.76|0.68|0.1397
91771979|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0366|TWO_SIDED|95.0|0.52|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.85|0.52|0.0366
91771980|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7968|TWO_SIDED|95.0|0.23|3.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.05|0.23|0.7968
91771981|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9074|TWO_SIDED|95.0|0.3|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.81|0.30|0.9074
91519864|NCT01212770|182913641|SUPERIORITY||Adjusted Difference|-7.7||||0.2032|TWO_SIDED|95.0|-19.3|3.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||3.8|-19.3|0.2032
91645752|NCT00285012|183184049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0008||95.0|1.37|3.48||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.48|1.37|0.0008
91645753|NCT00285012|183184050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0002||95.0|1.52|3.95||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.95|1.52|0.0002
91645754|NCT00285012|183184051|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] pre-bronchodilator||||0.140
91645755|NCT00285012|183184051|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] post-bronchodilator||||0.007
91645756|NCT00285012|183184051|SUPERIORITY_OR_OTHER|||||||0.684||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] pre-bronchodilator||||0.684
91645757|NCT00285012|183184051|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] post-bronchodilator||||0.901
91645758|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Mental State||||0.078
91645759|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Mental State||||0.109
91645760|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Mental State||||0.281
91645761|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Functional State||||0.581
91645762|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Functional State||||0.290
91645763|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Functional State||||0.063
91771982|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.41||||0.1987|TWO_SIDED|95.0|0.1|1.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.60|0.10|0.1987
91645764|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Respiratory Symptoms||||0.002
91645765|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Respiratory Symptoms||||0.081
91645766|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Respiratory Symptoms||||0.016
91645767|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Total Score||||0.033
91645768|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Total Score||||0.078
91645769|NCT00285012|183184052|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Total Score||||0.023
91645770|NCT05631093|183184083|NON_INFERIORITY|Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.|Estimated difference|-3.58|||<|0.001|TWO_SIDED|95.0|-7.81|-0.77|||Miettinen and Nurminen|The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.||||-0.77|-7.81|<0.001
91645771|NCT05631093|183184084|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated difference|-4.3|||||TWO_SIDED|95.0|-10.7|2.8|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||2.8|-10.7|
91645772|NCT05631093|183184085|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated difference|-1.6||||||95.0|-4.9|0.2|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||0.2|-4.9|
91645773|NCT05631093|183184086|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated difference|-0.08||||||95.0|-3.49|4.21|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||4.21|-3.49|
91645774|NCT05631093|183184087|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated difference|3.75||||||95.0|-0.31|8.89|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||8.89|-0.31|
91645775|NCT05631093|183184094|OTHER|Difference in mean change from baseline versus Baseline Antiretroviral Therapy (ART)|Estimated difference|-15.43||||||95.0|-46.32|15.47|||||Difference in percentage versus (vs) Baseline ART was based on a cDLA model.|||15.47|-46.32|
91645776|NCT05631093|183184100|SUPERIORITY|Treatment difference versus baseline ART|Estimated Difference|-2.21||||0.834|TWO_SIDED|95.0|-24.91|20.49|||ANCOVA||The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|PI-containing regimens (including PI- + InSTI-containing regimens)||20.49|-24.91|0.8340
91645777|NCT05631093|183184100|SUPERIORITY|Treatment difference versus baseline ART|Estimated Difference|3.44||||0.425|TWO_SIDED|95.0|-5.08|11.97|||ANCOVA||The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|non-PI- and non-InSTI-containing regimens||11.97|-5.08|0.4250
91645778|NCT05631093|183184100|SUPERIORITY|Treatment difference versus baseline ART|Estimated Difference|3.72||||0.1618||95.0|-1.5|8.95|||ANCOVA||The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|InSTI-containing regimens (non-PI-containing regimens)||8.95|-1.50|0.1618
91645779|NCT05631093|183184101|SUPERIORITY|Treatment difference versus baseline ART|Estimated Difference|-7.02|||||TWO_SIDED|95.0|-29.8|15.77|||||The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|PI-containing regimens (including PI- + InSTI-containing regimens)||15.77|-29.80|
91645780|NCT05631093|183184101|SUPERIORITY|Treatment difference versus baseline ART|Estimated Difference|3.99||||||95.0|-5.22|13.21|||||The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|non-PI- and non-InSTI-containing regimens||13.21|-5.22|
91645781|NCT05631093|183184101|SUPERIORITY|Treatment difference versus baseline ART|Estimated Difference|1.02|||||TWO_SIDED|95.0|-6.83|8.87|||||The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|InSTI-containing regimens (non-PI-containing regimens)||8.87|-6.83|
91645782|NCT02873195|183184110|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.051|TWO_SIDED|95.0|0.491|1.07|||Log Rank|||||1.07|0.491|0.051
91645783|NCT02873195|183184111|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4|TWO_SIDED|95.0|0.56|1.56|||Log Rank|||||1.56|0.56|0.40
91645784|NCT02873195|183184112|SUPERIORITY|||||||0.4876|||||||Fisher Exact|||||||0.4876
91645785|NCT01190098|183184245|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: there is a non-inferiority region of 4 points.||||||0.027|||||||t-test, 1 sided|||||||0.027
91645786|NCT01190098|183184246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7||||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
91645787|NCT01190098|183184247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
91645788|NCT01190098|183184248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
91645789|NCT01190098|183184249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
91645790|NCT01190098|183184250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
91645791|NCT01190098|183184251|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.69
91645792|NCT01190098|183184252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
91645793|NCT00606801|183184266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.006
91645794|NCT00606801|183184267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.04
91645795|NCT00606801|183184268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.02
91645796|NCT00606801|183184269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.03
91645797|NCT00606801|183184270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
91645798|NCT00606801|183184271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.7
91707708|NCT04227405|183308942|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the intervention group||||>.05
91645799|NCT00606801|183184272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
91645800|NCT00606801|183184273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
91645801|NCT00606801|183184274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
91645802|NCT00606801|183184275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.9
91645803|NCT00606801|183184276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.8
91645804|NCT00606801|183184277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
91645805|NCT00606801|183184278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.01
91645806|NCT00606801|183184279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.60
91645807|NCT00606801|183184280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.50
91645808|NCT01143272|183184282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.94|TWO_SIDED|95.0|0.55|1.9|||Regression, Cox|||||1.90|0.55|0.94
91645809|NCT01143272|183184282|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
91645810|NCT01143272|183184282|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
91645811|NCT01143272|183184284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.8|TWO_SIDED|95.0|0.49|1.73|||Regression, Cox|||||1.73|0.49|0.80
91645812|NCT01143272|183184284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.93|TWO_SIDED|95.0|0.53|2.03||adjusting for age, sex, CRP, leukocyte count, duration of antibiotic treatment, and administration of antibiotics|Regression, Cox|||||2.03|0.53|0.93
91645813|NCT01143272|183184285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.6|TWO_SIDED|95.0|0.96|1.08||Association between initial leukocyte count and incidence of AAD|Regression, Logistic|||||1.08|0.96|0.6
91645814|NCT01143272|183184285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.653|TWO_SIDED|95.0|1.0|1.01||Association between the initial C-reactive protein and incidence of AAD|Regression, Logistic|||||1.01|1.00|0.653
91645815|NCT00545181|183184289|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared, Corrected|||||||0.75
91645816|NCT02320838|183184294|OTHER||||||<|0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||<0.001
91645817|NCT02320838|183184295|OTHER|||||||0.04||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.04
91645818|NCT02320838|183184296|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
91645819|NCT02320838|183184297|OTHER|||||||0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.001
91645820|NCT02320838|183184298|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0.05|t-test, 2 sided|||||||0.003
91645821|NCT02320838|183184299|OTHER|||||||0.023||||||A priori threshold for statistical significance. p\<0.05|Chi-squared|||||||0.023
91645822|NCT02320838|183184300|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0,05|t-test, 2 sided|||||||0.003
91645823|NCT02320838|183184301|OTHER|||||||0.8||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.8
91645824|NCT02320838|183184302|OTHER|||||||0.02||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.02
91771983|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|2.58||||0.204|TWO_SIDED|95.0|0.6|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.18|0.60|0.2040
91771984|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3318|TWO_SIDED|95.0|0.13|1.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.99|0.13|0.3318
91771985|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7437|TWO_SIDED|95.0|0.31|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.10|0.31|0.7437
91771986|NCT03192176|183427589|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6848|TWO_SIDED|95.0|0.36|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.71|0.36|0.6848
91771987|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1114|TWO_SIDED|95.0|0.84|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.32|0.84|0.1114
91771988|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0013|TWO_SIDED|95.0|1.83|12.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.04|1.83|0.0013
91771989|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|7.01|||<|0.0001|TWO_SIDED|95.0|2.65|18.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.54|2.65|<0.0001
91771990|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|4.96||||0.001|TWO_SIDED|95.0|1.91|12.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.89|1.91|0.0010
91771991|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6384|TWO_SIDED|95.0|0.49|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||3.22|0.49|0.6384
91771992|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|5.77||||0.0003|TWO_SIDED|95.0|2.23|14.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.93|2.23|0.0003
91645825|NCT02320838|183184303|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
91645826|NCT02320838|183184304|OTHER|||||||0.8|||||||ANOVA|||||||0.8
91771993|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0025|TWO_SIDED|95.0|1.65|10.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.45|1.65|0.0025
91771994|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0279|TWO_SIDED|95.0|1.12|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.12|1.12|0.0279
91771995|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0114|TWO_SIDED|95.0|1.31|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.61|1.31|0.0114
91771996|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|7.55||||0.0001|TWO_SIDED|95.0|2.66|21.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||21.45|2.66|0.0001
91771997|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|6.41||||0.0005|TWO_SIDED|95.0|2.25|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.26|2.25|0.0005
91771998|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0695|TWO_SIDED|95.0|0.93|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.02|0.93|0.0695
91771999|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0015|TWO_SIDED|95.0|1.83|12.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.77|1.83|0.0015
91519865|NCT01212770|182913642|SUPERIORITY||Adjusted Difference|9.8||||0.2321|TWO_SIDED|95.0|-5.8|25.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.4|-5.8|0.2321
91645827|NCT02320838|183184305|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
91645828|NCT02320838|183184306|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
91645829|NCT02320838|183184307|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
91645830|NCT02320838|183184308|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
91645831|NCT02320838|183184309|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
91645832|NCT02320838|183184310|OTHER|||||||0.5||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.5
91645833|NCT02320838|183184311|OTHER|||||||0.6||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.6
91645834|NCT02320838|183184312|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
91645835|NCT02320838|183184313|OTHER|||||||0.2||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.2
91645836|NCT02320838|183184314|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
91645837|NCT03231709|183184319|OTHER|||||||0.0141|||||||Mainland-Gart Test|||||||0.0141
91645838|NCT04840901|183184345|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.16|||ANCOVA|||||1.16|1.03|
91645839|NCT04840901|183184346|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.07|||||TWO_SIDED|90.0|1.02|1.14|||ANCOVA|||||1.14|1.02|
91645840|NCT04840901|183184347|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.14|||ANCOVA|||||1.14|1.03|
91645841|NCT04075292|183184353|SUPERIORITY||Hazard Ratio (HR)|0.08|||<|0.0001|TWO_SIDED|95.0|0.03|0.18|||Log Rank|The analysis was performed using the unstratified log-rank test.|HR was calculated using an unstratified Cox model with treatment as the only covariate. The CI for HR was calculated using the profile likelihood method.|||0.18|0.03|<0.0001
91645842|NCT01988493|183184366|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.46||||0.0087|TWO_SIDED|90.0|0.28|0.76|||Log Rank|||||0.76|0.28|0.0087
91645843|NCT01988493|183184367|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.53||||0.0229||90.0|0.33|0.84|||Log Rank|||||0.84|0.33|0.0229
91645844|NCT01988493|183184368|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.71||||0.2333||90.0|0.45|1.14|||Log Rank|||||1.14|0.45|0.2333
91645845|NCT01988493|183184369|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.45||||0.0059||90.0|0.28|0.73|||Log Rank|||||0.73|0.28|0.0059
91645846|NCT01988493|183184382|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|1.04||||0.8915||90.0|0.62|1.77|||Log Rank|||||1.77|0.62|0.8915
91645847|NCT01988493|183184383|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0438|||||||Cochran-Mantel-Haenszel|||||||0.0438
91645848|NCT01988493|183184385|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.59||||0.0496|TWO_SIDED|90.0|0.38|0.92|||Log Rank|||||0.92|0.38|0.0496
91645849|NCT01988493|183184386|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0527|||||||Cochran-Mantel-Haenszel|||||||0.0527
91645850|NCT00535301|183184388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24|STANDARD_DEVIATION|2.0||0.005|TWO_SIDED|95.0|0.1|0.6|||Chi-squared|||Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.||0.6|0.1|0.005
91645851|NCT00535301|183184389|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5
91645852|NCT00535301|183184390|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91645853|NCT05144477|183184406|OTHER|Proportion of referrals who provided consent and enrolled into the study was calculated.|Proportion|0.64|||||TWO_SIDED|95.0|0.425|0.82||||||||0.820|0.425|
91645854|NCT05144477|183184407|OTHER|Proportion of enrolled participants who remained in the study at 30 days after the end of hospital care was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
91645855|NCT05144477|183184408|OTHER|Proportion of participants randomized to the FAID Fear Diary Intervention who wrote in the diary at least twice per week up until the end of hospital care was calculated.|Proportion|0.636|||||TWO_SIDED|95.0|0.308|0.891||||||||0.891|0.308|
91645856|NCT05144477|183184409|OTHER|Proportion of enrolled participants who provided complete data for at least 90% of all study assessments was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
91519866|NCT01212770|182913642|SUPERIORITY||Adjusted Difference|9.6||||0.252|TWO_SIDED|95.0|-6.2|25.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.3|-6.2|0.2520
91519867|NCT01297959|182913663|SUPERIORITY|||||||0.39|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.39
91645857|NCT05144477|183184410|OTHER|Proportion of intervention participants who agreed that the ICU diary was acceptable for reducing fear about their loved one's heart was calculated.|Proportion|0.8|||||TWO_SIDED|95.0|0.444|0.975||||||||0.975|0.444|
91645858|NCT05144477|183184411|OTHER|Proportion of intervention participants who agreed that the ICU diary was feasible for reducing fear about their loved one's heart was calculated.|Proportion|0.9|||||TWO_SIDED|95.0|0.555|0.998||||||||0.998|0.555|
91645859|NCT05144477|183184412|OTHER|Proportion of intervention participants who agreed that the ICU diary was appropriate for reducing fear about their loved one's heart was calculated.|Proportion|0.7|||||TWO_SIDED|95.0|0.348|0.933||||||||0.933|0.348|
91645860|NCT05144477|183184413|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.63|TWO_SIDED|95.0|-0.83|1.32|||t-test, 2 sided|||Outcome analysis at the end of hospital care.||1.32|-0.83|.63
91645861|NCT05144477|183184413|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED|95.0|-0.92|1.08|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.08|-0.92|.86
91645862|NCT05144477|183184414|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|95.0|-1.43|1.21|||t-test, 2 sided|||Outcome analysis for the end of hospital care.||1.21|-1.43|.86
91645863|NCT05144477|183184414|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-1.1|1.58|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.58|-1.10|.75
91645864|NCT05144477|183184415|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.22|TWO_SIDED|95.0|-23.26|5.86|||t-test, 2 sided|||||5.86|-23.26|.22
91645865|NCT05144477|183184415|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||χ2(1) = 1.29|||.26
91645866|NCT05144477|183184415|SUPERIORITY|||||||1|||||||Fisher Exact|||A Fisher's Exact Test was conducted to compare the number of participants with a positive screen for PTSD symptoms (score \>=33) to those who did not have a positive screen for PTSD symptoms (score \< 33).||||1.00
91645867|NCT00639158|183184416|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
91645868|NCT00639158|183184417|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||0.004
91645869|NCT00639158|183184418|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
91519868|NCT01297959|182913664|SUPERIORITY|||||||0.34|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.34
91645870|NCT00639158|183184419|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
91645871|NCT00639158|183184420|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
91645872|NCT00639158|183184421|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
91519869|NCT02460692|182913738|SUPERIORITY|||||||0.78||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||This is the primary comparison.||||0.78
91645873|NCT00639158|183184422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
91645874|NCT00639158|183184423|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Rank-sum test||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
91645875|NCT01787188|183184432|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.84|STANDARD_ERROR_OF_MEAN|3.097||0.0005|TWO_SIDED|95.0|-16.93|-4.75|||Mixed Models Analysis|||||-4.75|-16.93|0.0005
91645876|NCT01787188|183184432|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.74|STANDARD_ERROR_OF_MEAN|3.154||0.0059|TWO_SIDED|95.0|-14.94|-2.53|||Mixed Models Analysis|||||-2.53|-14.94|0.0059
91645877|NCT01787188|183184433|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.61|STANDARD_ERROR_OF_MEAN|2.641||0.0003|TWO_SIDED|95.0|-14.8|-4.42|||Mixed Models Analysis|||||-4.42|-14.80|0.0003
91645878|NCT01787188|183184433|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.9|STANDARD_ERROR_OF_MEAN|2.696||0.1486|TWO_SIDED|95.0|-9.2|1.4|||Mixed Models Analysis|||||1.40|-9.20|0.1486
91645879|NCT01787188|183184434|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.33|STANDARD_ERROR_OF_MEAN|2.865||0.0004|TWO_SIDED|95.0|-15.97|-4.7|||Mixed Models Analysis|||||-4.70|-15.97|0.0004
91645880|NCT01787188|183184434|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.84|STANDARD_ERROR_OF_MEAN|2.917||0.0008|TWO_SIDED|95.0|-15.58|-4.1|||Mixed Models Analysis|||||-4.10|-15.58|0.0008
91645881|NCT01787188|183184435|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.44|STANDARD_ERROR_OF_MEAN|2.521|<|0.0001|TWO_SIDED|95.0|-15.4|-5.48|||ANCOVA|||||-5.48|-15.40|<0.0001
91645882|NCT01787188|183184435|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.82|STANDARD_ERROR_OF_MEAN|2.561||0.0024|TWO_SIDED|95.0|-12.85|-2.78|||ANCOVA|||||-2.78|-12.85|0.0024
91645883|NCT01787188|183184436|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.34|STANDARD_ERROR_OF_MEAN|2.623|<|0.0001|TWO_SIDED|95.0|-15.49|-5.18|||Mixed Models Analysis|||||-5.18|-15.49|<0.0001
91645884|NCT01787188|183184436|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.39|STANDARD_ERROR_OF_MEAN|2.662||0.0997|TWO_SIDED|95.0|-9.63|0.84|||Mixed Models Analysis|||||0.84|-9.63|0.0997
91645885|NCT01787188|183184437|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.83|STANDARD_ERROR_OF_MEAN|2.905||0.0008|TWO_SIDED|95.0|-15.54|-4.11|||Mixed Models Analysis|||||-4.11|-15.54|0.0008
91645886|NCT01787188|183184437|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.42|STANDARD_ERROR_OF_MEAN|2.951||0.0015|TWO_SIDED|95.0|-15.22|-3.62|||Mixed Models Analysis|||||-3.62|-15.22|0.0015
91645887|NCT01787188|183184438|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.13|STANDARD_ERROR_OF_MEAN|3.147||0.0014|TWO_SIDED|95.0|-16.32|-3.94|||Mixed Models Analysis|||||-3.94|-16.32|0.0014
91645888|NCT01787188|183184438|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.98|STANDARD_ERROR_OF_MEAN|3.198||0.0019|TWO_SIDED|95.0|-16.27|-3.69|||Mixed Models Analysis|||||-3.69|-16.27|0.0019
91645889|NCT01787188|183184439|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.47|STANDARD_ERROR_OF_MEAN|2.593|<|0.0001|TWO_SIDED|95.0|-15.57|-5.37|||ANCOVA|||||-5.37|-15.57|<0.0001
91645890|NCT01787188|183184439|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.16|STANDARD_ERROR_OF_MEAN|2.627||0.002|TWO_SIDED|95.0|-13.33|-2.99|||ANCOVA|||||-2.99|-13.33|0.0020
91645891|NCT01787188|183184440|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|2.686||0.0001|TWO_SIDED|95.0|-15.73|-5.17|||Mixed Models Analysis|||||-5.17|-15.73|0.0001
91645892|NCT01787188|183184440|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.41|STANDARD_ERROR_OF_MEAN|2.725||0.1065|TWO_SIDED|95.0|-9.77|0.95|||Mixed Models Analysis|||||0.95|-9.77|0.1065
91645893|NCT01787188|183184441|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.68|STANDARD_ERROR_OF_MEAN|2.961||0.0012|TWO_SIDED|95.0|-15.5|-3.85|||Mixed Models Analysis|||||-3.85|-15.50|0.0012
91645894|NCT01787188|183184441|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.65|STANDARD_ERROR_OF_MEAN|3.006||0.0014|TWO_SIDED|95.0|-15.56|-3.74|||Mixed Models Analysis|||||-3.74|-15.56|0.0014
91645895|NCT01787188|183184442|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.26|STANDARD_ERROR_OF_MEAN|3.194||0.0014|TWO_SIDED|95.0|-16.54|-3.97|||Mixed Models Analysis|||||-3.97|-16.54|0.0014
91645896|NCT01787188|183184442|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|3.24||0.0014|TWO_SIDED|95.0|-16.82|-4.08|||Mixed Models Analysis|||||-4.08|-16.82|0.0014
91645897|NCT01787188|183184443|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.52|STANDARD_ERROR_OF_MEAN|2.646|<|0.0001|TWO_SIDED|95.0|-15.72|-5.31|||ANCOVA|||||-5.31|-15.72|<0.0001
91645898|NCT01787188|183184443|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.44|STANDARD_ERROR_OF_MEAN|2.68||0.0018|TWO_SIDED|95.0|-13.71|-3.17|||ANCOVA|||||-3.17|-13.71|0.0018
91645899|NCT01787188|183184444|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.98|STANDARD_ERROR_OF_MEAN|2.831||0.0001|TWO_SIDED|95.0|-16.55|-5.41|||Mixed Models Analysis|||||-5.41|-16.55|0.0001
91645900|NCT01787188|183184444|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.02|STANDARD_ERROR_OF_MEAN|2.89||0.0379|TWO_SIDED|95.0|-11.71|-0.34|||Mixed Models Analysis|||||-0.34|-11.71|0.0379
91645901|NCT01787188|183184445|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.22|STANDARD_ERROR_OF_MEAN|3.152||0.0001|TWO_SIDED|95.0|-18.42|-6.02|||Mixed Models Analysis|||||-6.02|-18.42|0.0001
91645902|NCT01787188|183184445|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|STANDARD_ERROR_OF_MEAN|3.21||0.0049|TWO_SIDED|95.0|-15.41|-2.78|||Mixed Models Analysis|||||-2.78|-15.41|0.0049
91645903|NCT01787188|183184446|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.94|STANDARD_ERROR_OF_MEAN|3.359||0.0012|TWO_SIDED|95.0|-17.55|-4.33|||Mixed Models Analysis|||||-4.33|-17.55|0.0012
91645904|NCT01787188|183184446|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.36|STANDARD_ERROR_OF_MEAN|3.422||0.0066|TWO_SIDED|95.0|-16.09|-2.63|||Mixed Models Analysis|||||-2.63|-16.09|0.0066
91645905|NCT01787188|183184447|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.67|STANDARD_ERROR_OF_MEAN|2.751|<|0.0001|TWO_SIDED|95.0|-17.08|-6.26|||ANCOVA|||||-6.26|-17.08|<0.0001
91645906|NCT01787188|183184447|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.24|STANDARD_ERROR_OF_MEAN|2.795||0.0034|TWO_SIDED|95.0|-13.74|-2.74|||ANCOVA|||||-2.74|-13.74|0.0034
91645907|NCT00854607|183184448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.166|TWO_SIDED|90.0|-0.2|0.77||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.77|-0.20|0.166
91645908|NCT00854607|183184449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.269|TWO_SIDED|90.0|-0.65|0.3||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.30|-0.65|0.269
91645909|NCT00854607|183184450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.101|TWO_SIDED|90.0|-0.06|0.44||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.44|-0.06|0.101
91645910|NCT00854607|183184451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.457|TWO_SIDED|90.0|-0.42|0.47||One-Sided P-Value|t-test, 1 sided|||Mean Difference Between Non-Responders and Responders||0.47|-0.42|0.457
91645911|NCT00854607|183184452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.168|TWO_SIDED|90.0|-0.87|0.23||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.23|-0.87|0.168
91645912|NCT00854607|183184453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.127|TWO_SIDED|90.0|-0.09|0.46||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.46|-0.09|0.127
91772000|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.3|8.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.28|1.30|0.0120
91519870|NCT02460692|182913738|SUPERIORITY|||||||0.07||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is the secondary comparison.||||0.070
91645913|NCT00854607|183184454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.054|TWO_SIDED|90.0|-0.01|0.96||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.96|-0.01|0.054
91645914|NCT00854607|183184455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.285|TWO_SIDED|90.0|-0.41|0.83||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.83|-0.41|0.285
91645915|NCT00854607|183184456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.159|TWO_SIDED|90.0|-0.27|1.08||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.08|-0.27|0.159
91645916|NCT00854607|183184457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.071|TWO_SIDED|90.0|-0.02|0.32||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.02|0.071
91645917|NCT00854607|183184458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.078|TWO_SIDED|90.0|-0.03|0.38||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.38|-0.03|0.078
91645918|NCT00854607|183184459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.109|TWO_SIDED|90.0|-0.13|0.91||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.91|-0.13|0.109
91645919|NCT00854607|183184460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.03|TWO_SIDED|90.0|0.09|1.22||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.22|0.09|0.030
91645920|NCT00854607|183184461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.293|TWO_SIDED|90.0|-0.63|0.32||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.63|0.293
91645921|NCT00854607|183184462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.213|TWO_SIDED|90.0|-0.83|0.29||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.29|-0.83|0.213
91645922|NCT01783483|183184465|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison of mean CT scan scores.||||<0.0001
91645923|NCT01783483|183184466|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
91645924|NCT01783483|183184467|SUPERIORITY_OR_OTHER|||||||0.0539|||||||t-test, 2 sided|||At Rest||||0.0539
91645925|NCT01783483|183184467|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||After Forced Coughing||||0.0015
91645926|NCT01783483|183184468|SUPERIORITY_OR_OTHER|||||||0.2125|||||||t-test, 2 sided|||At Rest||||0.2125
91645927|NCT01783483|183184468|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||After Forced Coughing||||0.0014
91645928|NCT01783483|183184469|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||At Rest||||0.0049
91645929|NCT01783483|183184469|SUPERIORITY_OR_OTHER|||||||0.0183|||||||t-test, 2 sided|||After Forced Coughing||||0.0183
91645930|NCT01783483|183184470|SUPERIORITY_OR_OTHER|||||||0.6653|||||||t-test, 2 sided|||At Rest||||0.6653
91645931|NCT01783483|183184470|SUPERIORITY_OR_OTHER|||||||0.2295|||||||t-test, 2 sided|||After Forced Coughing||||0.2295
91645932|NCT01783483|183184472|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Index (Day 0 to Hospital Discharge)||||0.370
91645933|NCT01783483|183184473|SUPERIORITY_OR_OTHER|||||||0.778|||||||t-test, 2 sided|||From Hospital Discharge to 3-week||||0.778
91772001|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.49||||0.662|TWO_SIDED|95.0|0.94|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.57|0.94|0.662
91772002|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1019|TWO_SIDED|95.0|0.85|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.80|0.85|0.1019
91772003|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0023|TWO_SIDED|95.0|1.83|16.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.18|1.83|0.0023
91772004|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|7.33||||0.0015|TWO_SIDED|95.0|2.15|25.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.02|2.15|0.0015
91772005|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.78||||0.238|TWO_SIDED|95.0|0.68|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.66|0.68|0.2380
91772006|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.61||||0.012|TWO_SIDED|95.0|1.33|9.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.81|1.33|0.0120
91772007|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.25||||0.091|TWO_SIDED|95.0|0.88|5.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.77|0.88|0.0910
91772008|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1926|TWO_SIDED|95.0|0.72|5.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.18|0.72|0.1926
91772009|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1017|TWO_SIDED|95.0|0.85|6.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.15|0.85|0.1017
91772010|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0153|TWO_SIDED|95.0|1.29|11.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.45|1.29|0.0153
91519871|NCT02460692|182913738|SUPERIORITY|||||||0.044||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is an exploratory comparison||||0.044
91772011|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|7.52||||0.0034|TWO_SIDED|95.0|1.95|28.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.98|1.95|0.0034
91772012|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4539|TWO_SIDED|95.0|0.55|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.76|0.55|0.4539
91772013|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.03||||0.0327|TWO_SIDED|95.0|1.1|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.40|1.10|0.0327
91772014|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0555|TWO_SIDED|95.0|0.98|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.30|0.98|0.0555
91772015|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3505|TWO_SIDED|95.0|0.58|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.67|0.58|0.3505
91772016|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0265|TWO_SIDED|95.0|1.17|13.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.11|1.17|0.0265
91772017|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0174|TWO_SIDED|95.0|1.32|17.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.32|1.32|0.0174
91645934|NCT01783483|183184474|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||From 3-week to 6-week post-op||||0.055
91772018|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|8.95||||0.0075|TWO_SIDED|95.0|1.8|44.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||44.61|1.80|0.0075
91772019|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1228|TWO_SIDED|95.0|0.78|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.68|0.78|0.1228
91772020|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0431|TWO_SIDED|95.0|1.04|10.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.38|1.04|0.0431
91772021|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0851|TWO_SIDED|95.0|0.87|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.35|0.87|0.0851
91772022|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4726|TWO_SIDED|95.0|0.53|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.99|0.53|0.4726
91772023|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1289|TWO_SIDED|95.0|0.79|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.67|0.79|0.1289
91772024|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.39||||0.04|TWO_SIDED|95.0|1.06|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.84|1.06|0.0400
91772025|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0097|TWO_SIDED|95.0|1.67|40.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||40.55|1.67|0.0097
91772026|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.97||||0.226|TWO_SIDED|95.0|0.66|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.94|0.66|0.2260
91772027|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|8.63||||0.0031|TWO_SIDED|95.0|2.07|35.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||35.96|2.07|0.0031
91519872|NCT02460692|182913739|SUPERIORITY|||||||0.27||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.27
91772028|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|10.16||||0.0043|TWO_SIDED|95.0|2.07|49.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||49.90|2.07|0.0043
91772029|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5571|TWO_SIDED|95.0|0.47|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.04|0.47|0.5571
91772030|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1911|TWO_SIDED|95.0|0.69|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.59|0.69|0.1911
91772031|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1101|TWO_SIDED|95.0|0.8|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.41|0.80|0.1101
91772032|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|6.86||||0.0199|TWO_SIDED|95.0|1.36|34.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||34.74|1.36|0.0199
91772033|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.96||||0.26|TWO_SIDED|95.0|0.61|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.33|0.61|0.2600
91772034|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|8.93||||0.009|TWO_SIDED|95.0|1.73|46.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||46.19|1.73|0.0090
91772035|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|17.22||||0.0089|TWO_SIDED|95.0|2.04|145.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||145.2|2.04|0.0089
91772036|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8966|TWO_SIDED|95.0|0.36|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.19|0.36|0.8966
91772037|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5031|TWO_SIDED|95.0|0.48|4.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.51|0.48|0.5031
91772038|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2603|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.92|0.59|0.2603
91772039|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.16||||0.2447|TWO_SIDED|95.0|0.59|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.59|0.2447
91772040|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.64||||0.4239|TWO_SIDED|95.0|0.49|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.55|0.49|0.4239
91772041|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|11.72||||0.024|TWO_SIDED|95.0|1.38|99.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||99.35|1.38|0.0240
91772042|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1457|TWO_SIDED|95.0|0.72|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.41|0.72|0.1457
91772043|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.34|3.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.38|0.34|0.9000
91519873|NCT02460692|182913739|SUPERIORITY|||||||0.96||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.96
91772044|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7644|TWO_SIDED|95.0|0.39|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.64|0.39|0.7644
91772045|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2245|TWO_SIDED|95.0|0.6|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|0.60|0.2245
91772046|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0475|TWO_SIDED|95.0|1.02|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||27.40|1.02|0.0475
91772047|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2569|TWO_SIDED|95.0|0.57|8.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.07|0.57|0.2569
91772048|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|9.32||||0.0412|TWO_SIDED|95.0|1.09|79.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||79.44|1.09|0.0412
91772049|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1201|TWO_SIDED|95.0|0.76|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.61|0.76|0.1201
91772050|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3814|TWO_SIDED|95.0|0.53|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.23|0.53|0.3814
91772051|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8549|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.38|0.8549
91772052|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.77||||0.1274|TWO_SIDED|95.0|0.75|10.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.24|0.75|0.1274
91772053|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0703|TWO_SIDED|95.0|0.9|15.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.01|0.90|0.0703
91772054|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1821|TWO_SIDED|95.0|0.66|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.76|0.66|0.1821
91772055|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|12.96||||0.0187|TWO_SIDED|95.0|1.53|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||109.5|1.53|0.0187
91772056|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0458|TWO_SIDED|95.0|1.03|17.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.00|1.03|0.0458
91772057|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6806|TWO_SIDED|95.0|0.41|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.89|0.41|0.6806
91772058|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.15||||0.809|TWO_SIDED|95.0|0.38|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.45|0.38|0.8090
91772059|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2352|TWO_SIDED|95.0|0.6|8.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.26|0.60|0.2352
91772060|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.04||||0.1231|TWO_SIDED|95.0|0.74|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.50|0.74|0.1231
91772061|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1445|TWO_SIDED|95.0|0.7|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||11.76|0.70|0.1445
91772062|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|12.03||||0.023|TWO_SIDED|95.0|1.41|102.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||102.7|1.41|0.0230
91772063|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0801|TWO_SIDED|95.0|0.86|14.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.36|0.86|0.0801
91772064|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.63||||0.4152|TWO_SIDED|95.0|0.5|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.32|0.50|0.4152
91772065|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3845|TWO_SIDED|95.0|0.51|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.65|0.51|0.3845
91772066|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1864|TWO_SIDED|95.0|0.65|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.39|0.65|0.1864
91772067|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.06||||0.01268|TWO_SIDED|95.0|0.73|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.86|0.73|0.01268
91772068|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.8||||0.16|TWO_SIDED|95.0|0.67|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.76|0.67|0.1600
91519874|NCT02460692|182913739|SUPERIORITY|||||||0.3||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.30
91519875|NCT02460692|182913740|SUPERIORITY|||||||0.44||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.44
91645935|NCT01783483|183184476|SUPERIORITY_OR_OTHER|||||||0.113|||||||t-test, 2 sided|||From 3 month to 6-month post op||||0.113
91645936|NCT02268045|183184477|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|Percentage difference|0.7|||||ONE_SIDED|95.0|-13.0||||||For the ITT population||||-13|
91645937|NCT02268045|183184477|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|percentage difference|3.0|||||ONE_SIDED|95.0|-13.0||||||For the PP population||||-13|
91645938|NCT02268045|183184478|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.2|||||TWO_SIDED|90.0|93.6|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.6|
91645939|NCT02268045|183184479|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|103.0|||||TWO_SIDED|90.0|98.5|107.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||107|98.5|
91645940|NCT02268045|183184480|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.6|||||TWO_SIDED|90.0|93.9|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.9|
91645941|NCT02268045|183184481|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|104.0|||||TWO_SIDED|90.0|99.5|109.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||109|99.5|
91645942|NCT02268045|183184485|OTHER|||||||0.457|||||||Log Rank|||||||0.4570
91645943|NCT01766310|183184486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.3||0.05|TWO_SIDED|95.0|-0.09|1.44|||t-test, 2 sided|||||1.44|-0.09|0.05
91645944|NCT02125734|183184521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081||||0.0017|TWO_SIDED|95.0|0.031|0.13|||ANCOVA|||||0.130|0.031|0.0017
91645945|NCT01556490|183184527|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4552|TWO_SIDED|95.0|0.89|1.31|||Log Rank|||||1.31|0.89|0.4552
91645946|NCT01556490|183184528|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0626|TWO_SIDED|95.0|0.61|1.01|||Log Rank|||||1.01|0.61|0.0626
91645947|NCT01556490|183184529|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0227|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||.96|.59|0.0227
91645948|NCT01556490|183184530|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0043|TWO_SIDED|95.0|0.52|0.89|||Log Rank|||||.89|.52|0.0043
91645949|NCT01556490|183184531|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.0001|TWO_SIDED|95.0|8.6|22.3|||2 sided calculated using continuity|2 sided calculated using continuity adjusted Wald Approach||||22.3|8.6|0.0001
91645950|NCT01652872|183184539|OTHER||Treatment Difference|-0.27|||||TWO_SIDED|95.0|-6.39|5.85|||||Difference is fixed dose - titration.|||5.85|-6.39|
91645951|NCT01652872|183184539|OTHER||Risk Ratio (RR)|0.998|||||TWO_SIDED|95.0|0.776|1.285|||Cochran-Mantel-Haenszel|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|A risk ratio \< 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.|||1.285|0.776|
91645952|NCT01652872|183184540|OTHER|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.|Least Squares Mean (LSM) Ratio|1.28|||||TWO_SIDED|95.0|0.81|2.05|||Negative binomial regression model||Least Squares Mean (LSM) ratio is fixed dose relative to titration.|||2.05|0.81|
91645953|NCT01652872|183184541|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.76|1.35|||Cox Proportional Hazard Model|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|Hazard ratio is fixed dose relative to titration.|||1.35|0.76|
91645954|NCT01652872|183184542|OTHER||Median of the difference|-0.34|||||TWO_SIDED|95.0|-0.46|-0.22|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-0.22|-0.46|
91645955|NCT01652872|183184543|OTHER||Median of the difference|-22.1|||||TWO_SIDED|95.0|-26.1|-18.1|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-18.1|-26.1|
91645956|NCT03985293|183184566|SUPERIORITY||Difference in LS Mean|-0.47||||0.0071|TWO_SIDED|90.0|-0.76|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.76|0.0071
91645957|NCT03985293|183184566|SUPERIORITY||Difference in LS Mean|-0.9|||<|0.0001|TWO_SIDED|90.0|-1.18|-0.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.62|-1.18|<.0001
91645958|NCT03985293|183184566|SUPERIORITY||Difference in LS Mean|-1.01|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.73|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.73|-1.30|<.0001
91645959|NCT03985293|183184566|SUPERIORITY||Difference in LS Mean|-0.94|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.65|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.65|-1.24|<.0001
91772069|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0317|TWO_SIDED|95.0|1.17|32.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||32.11|1.17|0.0317
91772070|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0709|TWO_SIDED|95.0|0.89|15.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.53|0.89|0.0709
91772071|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4533|TWO_SIDED|95.0|0.47|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.41|0.47|0.4533
91772072|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7053|TWO_SIDED|95.0|0.24|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.60|0.24|0.7053
91772073|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3677|TWO_SIDED|95.0|0.49|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.99|0.49|0.3677
91772074|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.24||||0.735|TWO_SIDED|95.0|0.35|4.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.40|0.35|0.7350
91772075|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6443|TWO_SIDED|95.0|0.36|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.15|0.36|0.6443
91772076|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4865|TWO_SIDED|95.0|0.43|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.43|0.4865
91772077|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.52||||0.1628|TWO_SIDED|95.0|0.69|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.27|0.69|0.1628
91772078|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6935|TWO_SIDED|95.0|0.24|2.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.57|0.24|0.6935
91772079|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9753|TWO_SIDED|95.0|0.32|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.32|0.9753
91772080|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7407|TWO_SIDED|95.0|0.23|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.81|0.23|0.7407
91772081|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4929|TWO_SIDED|95.0|0.44|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.49|0.44|0.4929
91772082|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8496|TWO_SIDED|95.0|0.25|3.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.15|0.25|0.8496
91772083|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|1.92||||0.3248|TWO_SIDED|95.0|0.52|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.05|0.52|0.3248
91772084|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2589|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.92|0.59|0.2589
91772085|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3318|TWO_SIDED|95.0|0.16|1.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.87|0.16|0.3318
91772086|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8536|TWO_SIDED|95.0|0.26|3.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.01|0.26|0.8536
91772087|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2817|TWO_SIDED|95.0|0.12|1.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.84|0.12|0.2817
91772088|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.59||||0.4091|TWO_SIDED|95.0|0.17|2.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.07|0.17|0.4091
91772089|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.5||||0.3147|TWO_SIDED|95.0|0.13|1.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.93|0.13|0.3147
91772090|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8547|TWO_SIDED|95.0|0.24|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.24|0.8547
91772091|NCT03192176|183427590|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5023|TWO_SIDED|95.0|0.2|2.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.19|0.20|0.5023
91772092|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0093|TWO_SIDED|95.0|1.41|11.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.35|1.41|0.0093
91772093|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0035|TWO_SIDED|95.0|1.66|13.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.09|1.66|0.0035
91772094|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|8.48|||<|0.0001|TWO_SIDED|95.0|3.01|23.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.90|3.01|<0.0001
91772095|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0002|TWO_SIDED|95.0|2.65|21.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.59|2.65|0.0002
91519876|NCT02460692|182913740|SUPERIORITY|||||||0.53||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.53
91519877|NCT02460692|182913740|SUPERIORITY|||||||0.18||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.18
91772096|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1664|TWO_SIDED|95.0|0.73|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.22|0.73|0.1664
91772097|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0012|TWO_SIDED|95.0|1.94|14.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.96|1.94|0.0012
91772098|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|9.85|||<|0.0001|TWO_SIDED|95.0|3.49|27.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||27.86|3.49|<0.0001
91772099|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0334|TWO_SIDED|95.0|1.08|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.89|1.08|0.0334
91772100|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0034|TWO_SIDED|95.0|1.6|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.62|1.60|0.0034
91772101|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|6.55||||0.0002|TWO_SIDED|95.0|2.45|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.47|2.45|0.0002
91772102|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.9||||0.0014|TWO_SIDED|95.0|1.85|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.98|1.85|0.0014
91772103|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0872|TWO_SIDED|95.0|0.89|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.74|0.89|0.0872
91772104|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0131|TWO_SIDED|95.0|1.28|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.98|1.28|0.0131
91772105|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0386|TWO_SIDED|95.0|1.05|6.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.43|1.05|0.0386
91772106|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0191|TWO_SIDED|95.0|1.2|8.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.05|1.20|0.0191
91772107|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0291|TWO_SIDED|95.0|1.11|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.26|1.11|0.0291
91772108|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.23|16.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.58|2.23|0.0004
91772109|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0003|TWO_SIDED|95.0|2.49|21.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.02|2.49|0.0003
91772110|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0992|TWO_SIDED|95.0|0.86|5.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.72|0.86|0.0992
91772111|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0006|TWO_SIDED|95.0|2.11|15.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.16|2.11|0.0006
91772112|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.74||||0.006|TWO_SIDED|95.0|1.46|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.59|1.46|0.0060
91519878|NCT02460692|182913741|SUPERIORITY|||||||0.95||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.95
91519879|NCT02460692|182913741|SUPERIORITY|||||||0.94||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.94
91772113|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.01||||0.1472|TWO_SIDED|95.0|0.78|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.14|0.78|0.1472
91772114|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1284|TWO_SIDED|95.0|0.81|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.15|0.81|0.1284
91772115|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0117|TWO_SIDED|95.0|1.32|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.50|1.32|0.0117
91772116|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0067|TWO_SIDED|95.0|1.49|12.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.03|1.49|0.0067
91772117|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4088|TWO_SIDED|95.0|0.59|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.71|0.59|0.4088
91772118|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0194|TWO_SIDED|95.0|1.2|7.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.96|1.20|0.0194
91772119|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0423|TWO_SIDED|95.0|1.03|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.73|1.03|0.0423
91772120|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2151|TWO_SIDED|95.0|0.7|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.99|0.70|0.2151
91772121|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0531|TWO_SIDED|95.0|0.99|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.99|0.0531
91772122|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0118|TWO_SIDED|95.0|1.37|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.34|1.37|0.0118
91772123|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|16.28||||0.0006|TWO_SIDED|95.0|3.29|80.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||80.46|3.29|0.0006
91772124|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3698|TWO_SIDED|95.0|0.59|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.22|0.59|0.3698
91772125|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0059|TWO_SIDED|95.0|1.55|13.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.53|1.55|0.0059
91772126|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0241|TWO_SIDED|95.0|1.17|9.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.44|1.17|0.0241
91772127|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5308|TWO_SIDED|95.0|0.5|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.77|0.50|0.5308
91772128|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8603|TWO_SIDED|95.0|0.41|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.90|0.41|0.8603
91772129|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0264|TWO_SIDED|95.0|1.17|11.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.95|1.17|0.0264
91519880|NCT02460692|182913741|SUPERIORITY|||||||0.9||||||The average change of learning score at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||.90
91519881|NCT02460692|182913742|SUPERIORITY|||||||0.93||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8 at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.93
91772130|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0188|TWO_SIDED|95.0|1.29|16.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.42|1.29|0.0188
91772131|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7642|TWO_SIDED|95.0|0.42|3.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.27|0.42|0.7642
91772132|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.91||||0.0101|TWO_SIDED|95.0|1.46|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.53|1.46|0.0101
91772133|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0572|TWO_SIDED|95.0|0.97|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.97|0.0572
91772134|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7348|TWO_SIDED|95.0|0.44|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.20|0.44|0.7348
91772135|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1397|TWO_SIDED|95.0|0.77|6.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.25|0.77|0.1397
91772136|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0231|TWO_SIDED|95.0|1.21|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.64|1.21|0.0231
91772137|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.54||||0.0196|TWO_SIDED|95.0|1.27|16.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.15|1.27|0.0196
91772138|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7703|TWO_SIDED|95.0|0.42|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.24|0.42|0.7703
91772139|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.83||||0.0222|TWO_SIDED|95.0|1.21|12.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.12|1.21|0.0222
91772140|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0668|TWO_SIDED|95.0|0.93|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.21|0.93|0.0668
91772141|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7533|TWO_SIDED|95.0|0.43|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.22|0.43|0.7533
91772142|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3325|TWO_SIDED|95.0|0.59|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.73|0.59|0.3325
91772143|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0899|TWO_SIDED|95.0|0.86|8.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.57|0.86|0.0899
91772144|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0642|TWO_SIDED|95.0|0.93|11.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.79|0.93|0.0642
91772145|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5964|TWO_SIDED|95.0|0.46|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.89|0.46|0.5964
91772146|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0224|TWO_SIDED|95.0|1.23|15.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||15.91|1.23|0.0224
91772147|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.72||||0.3139|TWO_SIDED|95.0|0.6|4.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.96|0.60|0.3139
91772148|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6343|TWO_SIDED|95.0|0.45|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.76|0.45|0.6343
91772149|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6557|TWO_SIDED|95.0|0.45|3.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.61|0.45|0.6557
91772150|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0516|TWO_SIDED|95.0|0.99|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.51|0.99|0.0516
91772151|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.38||||0.04|TWO_SIDED|95.0|1.07|17.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||17.91|1.07|0.0400
91772152|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5825|TWO_SIDED|95.0|0.44|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.24|0.44|0.5825
91772153|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|7.46||||0.0152|TWO_SIDED|95.0|1.47|37.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||37.83|1.47|0.0152
91772154|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1565|TWO_SIDED|95.0|0.73|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.30|0.73|0.1565
91772155|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4932|TWO_SIDED|95.0|0.5|4.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.25|0.50|0.4932
91772156|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8504|TWO_SIDED|95.0|0.39|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.12|0.39|0.8504
91772157|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0759|TWO_SIDED|95.0|0.89|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.61|0.89|0.0759
91772158|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0477|TWO_SIDED|95.0|1.01|13.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.46|1.01|0.0477
91772159|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.47||||0.1448|TWO_SIDED|95.0|0.73|8.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.36|0.73|0.1448
91772160|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|5.54||||0.0173|TWO_SIDED|95.0|1.35|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.71|1.35|0.0173
91772161|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1101|TWO_SIDED|95.0|0.81|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.17|0.81|0.1101
91772162|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6022|TWO_SIDED|95.0|0.46|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.78|0.46|0.6022
91772163|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6128|TWO_SIDED|95.0|0.46|3.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.73|0.46|0.6128
91772164|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1001|TWO_SIDED|95.0|0.82|9.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.68|0.82|0.1001
91772165|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0255|TWO_SIDED|95.0|1.22|20.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.12|1.22|0.0255
91772166|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.42||||0.1521|TWO_SIDED|95.0|0.72|8.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.10|0.72|0.1521
91772167|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|9.37||||0.0071|TWO_SIDED|95.0|1.84|47.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||47.69|1.84|0.0071
91772168|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.52||||0.115|TWO_SIDED|95.0|0.8|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.93|0.80|0.1150
91772169|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8101|TWO_SIDED|95.0|0.4|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.22|0.40|0.8101
91772170|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.49||||0.4663|TWO_SIDED|95.0|0.51|4.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.33|0.51|0.4663
91772171|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0453|TWO_SIDED|95.0|1.03|14.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.01|1.03|0.0453
91772172|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0659|TWO_SIDED|95.0|0.92|12.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.21|0.92|0.0659
91772173|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.83||||0.3117|TWO_SIDED|95.0|0.57|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.86|0.57|0.3117
91645960|NCT03985293|183184566|SUPERIORITY||Difference in LS Mean|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.47|-0.86|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.86|-1.47|<.0001
91645961|NCT03985293|183184567|SUPERIORITY||Odds Ratio (OR)|5.11|||||TWO_SIDED|90.0|1.84|14.18|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||14.18|1.84|
91645962|NCT03985293|183184567|SUPERIORITY||Odds Ratio (OR)|16.85|||||TWO_SIDED|90.0|6.18|45.93|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||45.93|6.18|
91645963|NCT03985293|183184567|SUPERIORITY||Odds Ratio (OR)|18.79|||||TWO_SIDED|90.0|7.03|50.21|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||50.21|7.03|
91707709|NCT04227405|183308942|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
91707710|NCT04227405|183308942|SUPERIORITY|Changes from post-test to Follow-up in the Active Coping subscale for the control group|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|||||>.05
91707711|NCT04227405|183308942|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the intervention group||||>.05
91707712|NCT04227405|183308942|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Copinng subscale||||>.05
91645964|NCT03985293|183184567|SUPERIORITY||Odds Ratio (OR)|23.97|||||TWO_SIDED|90.0|8.66|66.39|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||66.39|8.66|
91645965|NCT03985293|183184567|SUPERIORITY||Odds Ratio (OR)|24.46|||||TWO_SIDED|90.0|8.72|68.57|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||68.57|8.72|
91645966|NCT03985293|183184568|SUPERIORITY||Difference in LS Mean|-0.09||||0.1578|TWO_SIDED|90.0|-0.19|0.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.01|-0.19|0.1578
91645967|NCT03985293|183184568|SUPERIORITY||Difference in LS Mean|-0.22||||0.0003|TWO_SIDED|90.0|-0.32|-0.12|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.12|-0.32|0.0003
91645968|NCT03985293|183184568|SUPERIORITY||Difference in LS Mean|-0.2||||0.0013|TWO_SIDED|90.0|-0.3|-0.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.10|-0.30|0.0013
91645969|NCT03985293|183184568|SUPERIORITY||Difference in LS Mean|-0.24||||0.0001|TWO_SIDED|90.0|-0.34|-0.14|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.14|-0.34|0.0001
91645970|NCT03985293|183184568|SUPERIORITY||Difference in LS Mean|-0.26|||<|0.0001|TWO_SIDED|90.0|-0.36|-0.16|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.16|-0.36|<.0001
91645971|NCT03985293|183184569|SUPERIORITY||Difference in LS Mean|-0.3||||0.0013|TWO_SIDED|90.0|-0.46|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.46|0.0013
91645972|NCT03985293|183184569|SUPERIORITY||Difference in LS Mean|-0.43|||<|0.0001|TWO_SIDED|90.0|-0.58|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.28|-0.58|<.0001
91645973|NCT03985293|183184569|SUPERIORITY||Difference in LS Mean|-0.55|||<|0.0001|TWO_SIDED|90.0|-0.7|-0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.40|-0.70|<.0001
91645974|NCT03985293|183184569|SUPERIORITY||Difference in LS Mean|-0.5|||<|0.0001|TWO_SIDED|90.0|-0.66|-0.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.35|-0.66|<.0001
91645975|NCT03985293|183184569|SUPERIORITY||Difference in LS Mean|-0.56|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.41|-0.71|<.0001
91645976|NCT03985293|183184570|SUPERIORITY||Difference in LS Mean|-0.4||||0.0004|TWO_SIDED|90.0|-0.59|-0.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.22|-0.59|0.0004
91645977|NCT03985293|183184570|SUPERIORITY||Difference in LS Mean|-0.64|||<|0.0001|TWO_SIDED|90.0|-0.81|-0.46|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.46|-0.81|<.0001
91645978|NCT03985293|183184570|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
91645979|NCT03985293|183184570|SUPERIORITY||Difference in LS Mean|-0.72|||<|0.0001|TWO_SIDED|90.0|-0.91|-0.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.53|-0.91|<.0001
91645980|NCT03985293|183184570|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
91645981|NCT03985293|183184571|SUPERIORITY||Difference in LS Mean|-0.37||||0.0054|TWO_SIDED|90.0|-0.59|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.59|0.0054
91645982|NCT03985293|183184571|SUPERIORITY||Difference in LS Mean|-0.65|||<|0.0001|TWO_SIDED|90.0|-0.86|-0.44|||Mixed Models Analysis||PF-06882961 = Test Placebo = Reference|||-0.44|-0.86|<.0001
91645983|NCT03985293|183184571|SUPERIORITY||Difference in LS Mean|-0.84|||<|0.0001|TWO_SIDED|90.0|-1.06|-0.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.63|-1.06|<.0001
91772174|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0129|TWO_SIDED|95.0|1.46|24.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.73|1.46|0.0129
91645984|NCT03985293|183184571|SUPERIORITY||Difference in LS Mean|-0.8|||<|0.0001|TWO_SIDED|90.0|-1.02|-0.57|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.57|-1.02|<.0001
91772175|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0303|TWO_SIDED|95.0|1.14|14.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.83|1.14|0.0303
91772176|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2772|TWO_SIDED|95.0|0.59|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.42|0.59|0.2772
91772177|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9432|TWO_SIDED|95.0|0.29|3.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.16|0.29|0.9432
91772178|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.08||||0.2577|TWO_SIDED|95.0|0.59|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.36|0.59|0.2577
91772179|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1496|TWO_SIDED|95.0|0.71|9.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.12|0.71|0.1496
91772180|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2874|TWO_SIDED|95.0|0.55|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.55|0.2874
91645985|NCT03985293|183184571|SUPERIORITY||Difference in LS Mean|-0.89|||<|0.0001|TWO_SIDED|90.0|-1.11|-0.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.67|-1.11|<.0001
91772181|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1981|TWO_SIDED|95.0|0.65|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.78|0.65|0.1981
91772182|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0531|TWO_SIDED|95.0|0.98|11.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.43|0.98|0.0531
91772183|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5858|TWO_SIDED|95.0|0.22|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.22|0.5858
91772184|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5122|TWO_SIDED|95.0|0.21|2.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.16|0.21|0.5122
91772185|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3415|TWO_SIDED|95.0|0.16|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.89|0.16|0.3415
91772186|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.87||||0.8263|TWO_SIDED|95.0|0.25|2.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.98|0.25|0.8263
91772187|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8085|TWO_SIDED|95.0|0.24|3.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.03|0.24|0.8085
91772188|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6745|TWO_SIDED|95.0|0.38|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.43|0.38|0.6745
91772189|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9019|TWO_SIDED|95.0|0.34|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.45|0.34|0.9019
91772190|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4425|TWO_SIDED|95.0|0.18|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.10|0.18|0.4425
91772191|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3106|TWO_SIDED|95.0|0.17|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.17|0.3106
91772192|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.32||||0.0912|TWO_SIDED|95.0|0.08|1.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.20|0.08|0.0912
91772193|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5681|TWO_SIDED|95.0|0.2|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.20|0.5681
91772194|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.58||||0.4261|TWO_SIDED|95.0|0.15|2.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.21|0.15|0.4261
91772195|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7514|TWO_SIDED|95.0|0.24|2.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.82|0.24|0.7514
91772196|NCT03192176|183427591|SUPERIORITY||Odds Ratio (OR)|0.52||||0.2712|TWO_SIDED|95.0|0.16|1.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.67|0.16|0.2712
91772197|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0103|TWO_SIDED|95.0|1.46|16.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.40|1.46|0.0103
91772198|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0011|TWO_SIDED|95.0|2.2|23.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.48|2.20|0.0011
91772199|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|11.06|||<|0.0001|TWO_SIDED|95.0|3.41|35.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.86|3.41|<0.0001
91772200|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|10.48||||0.0001|TWO_SIDED|95.0|3.18|34.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||34.55|3.18|0.0001
91772201|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1571|TWO_SIDED|95.0|0.71|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.55|0.71|0.1571
91772202|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|7.14||||0.001|TWO_SIDED|95.0|2.21|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.04|2.21|0.0010
91772203|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|7.35||||0.0008|TWO_SIDED|95.0|2.29|23.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.61|2.29|0.0008
91772204|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0342|TWO_SIDED|95.0|1.08|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.18|1.08|0.0342
91772205|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0231|TWO_SIDED|95.0|1.16|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.66|1.16|0.0231
91645986|NCT03985293|183184572|SUPERIORITY||Difference in LS Mean|-0.44||||0.0061|TWO_SIDED|90.0|-0.71|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.71|0.0061
91772206|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0032|TWO_SIDED|95.0|1.6|10.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.55|1.60|0.0032
91772207|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.89||||0.0059|TWO_SIDED|95.0|1.48|10.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.22|1.48|0.0059
91519882|NCT02460692|182913742|SUPERIORITY|||||||0.92||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.92
91519883|NCT02460692|182913742|SUPERIORITY|||||||0.85||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.85
91645987|NCT03985293|183184572|SUPERIORITY||Difference in LS Mean|-0.79|||<|0.0001|TWO_SIDED|90.0|-1.05|-0.54|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.54|-1.05|<.0001
91772208|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2471|TWO_SIDED|95.0|0.68|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.59|0.68|0.2471
91772209|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0381|TWO_SIDED|95.0|1.05|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.05|0.0381
91772210|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0113|TWO_SIDED|95.0|1.31|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.48|1.31|0.0113
91772211|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0486|TWO_SIDED|95.0|1.01|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.52|1.01|0.0486
91772212|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.71||||0.035|TWO_SIDED|95.0|1.07|6.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.87|1.07|0.0350
91772213|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0027|TWO_SIDED|95.0|1.65|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.90|1.65|0.0027
91772214|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.68||||0.002|TWO_SIDED|95.0|1.76|12.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.47|1.76|0.0020
91772215|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0686|TWO_SIDED|95.0|0.94|6.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.19|0.94|0.0686
91772216|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0034|TWO_SIDED|95.0|1.58|10.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.21|1.58|0.0034
91772217|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0222|TWO_SIDED|95.0|1.16|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.22|1.16|0.0222
91772218|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0876|TWO_SIDED|95.0|0.89|5.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.84|0.89|0.0876
91772219|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.72||||0.0345|TWO_SIDED|95.0|1.08|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.88|1.08|0.0345
91519884|NCT02460692|182913743|SUPERIORITY|||||||0.89||||||The average change in Wechsler Adult Intelligence Scale (WAIS)-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model.|Unstructured covariance model|||||||0.89
91519885|NCT02460692|182913743|SUPERIORITY|||||||0.13||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.13
91772220|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0319|TWO_SIDED|95.0|1.09|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.99|1.09|0.0319
91772221|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.27||||0.0013|TWO_SIDED|95.0|1.92|14.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.47|1.92|0.0013
91772222|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.91||||0.1751|TWO_SIDED|95.0|0.75|4.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.87|0.75|0.1751
91772223|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.73|11.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.50|1.73|0.0019
91772224|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0284|TWO_SIDED|95.0|1.11|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.97|1.11|0.0284
91772225|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.72||||0.265|TWO_SIDED|95.0|0.66|4.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.45|0.66|0.2650
91772226|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1238|TWO_SIDED|95.0|0.82|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.38|0.82|0.1238
91772227|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0219|TWO_SIDED|95.0|1.18|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.74|1.18|0.0219
91772228|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.46||||0.0022|TWO_SIDED|95.0|1.84|16.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.16|1.84|0.0022
91772229|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.82||||0.223|TWO_SIDED|95.0|0.69|4.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.77|0.69|0.2230
91772230|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.97|1.83|0.0018
91772231|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0205|TWO_SIDED|95.0|1.19|8.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.42|1.19|0.0205
91772232|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4628|TWO_SIDED|95.0|0.54|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.81|0.54|0.4628
91772233|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4015|TWO_SIDED|95.0|0.58|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.92|0.58|0.4015
91772234|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.47|1.76|0.0031
91772235|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0115|TWO_SIDED|95.0|1.38|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.50|1.38|0.0115
91772236|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2513|TWO_SIDED|95.0|0.66|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.98|0.66|0.2513
91772237|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0099|TWO_SIDED|95.0|1.39|11.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.14|1.39|0.0099
91772238|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0242|TWO_SIDED|95.0|1.16|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.74|1.16|0.0242
91645988|NCT03985293|183184572|SUPERIORITY||Difference in LS Mean|-0.98|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.72|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.72|-1.24|<.0001
91772239|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1518|TWO_SIDED|95.0|0.77|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.60|0.77|0.1518
91772240|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1811|TWO_SIDED|95.0|0.73|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.17|0.73|0.1811
91772241|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.88||||0.015|TWO_SIDED|95.0|1.3|11.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.55|1.30|0.0150
91645989|NCT03985293|183184572|SUPERIORITY||Difference in LS Mean|-0.83|||<|0.0001|TWO_SIDED|90.0|-1.1|-0.56|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.56|-1.10|<.0001
91645990|NCT03985293|183184572|SUPERIORITY||Difference in LS Mean|-1.03|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.75|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.75|-1.30|<.0001
91645991|NCT03985293|183184573|SUPERIORITY||Difference in LS Mean|-17.13||||0.0014|TWO_SIDED|90.0|-25.94|-8.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-8.33|-25.94|0.0014
91645992|NCT03985293|183184573|SUPERIORITY||Difference in LS Mean|-16.38||||0.0021|TWO_SIDED|90.0|-25.08|-7.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|Difference in LS Mean|||-7.67|-25.08|0.0021
91645993|NCT03985293|183184573|SUPERIORITY||Difference in LS Mean|-22.2|||<|0.0001|TWO_SIDED|90.0|-30.88|-13.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-13.53|-30.88|<.0001
91645994|NCT03985293|183184573|SUPERIORITY||Difference in LS Mean|-18.59||||0.0006|TWO_SIDED|90.0|-27.43|-9.76|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.76|-27.43|0.0006
91645995|NCT03985293|183184573|SUPERIORITY||Difference in LS Mean|-25.33|||<|0.0001|TWO_SIDED|90.0|-34.0|-16.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-16.67|-34.00|<.0001
91645996|NCT03985293|183184574|SUPERIORITY||Difference in LS Mean|-11.79||||0.0468|TWO_SIDED|90.0|-21.55|-2.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.04|-21.55|0.0468
91645997|NCT03985293|183184574|SUPERIORITY||Difference in LS Mean|-18.68||||0.0012|TWO_SIDED|90.0|-28.12|-9.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.25|-28.12|0.0012
91645998|NCT03985293|183184574|SUPERIORITY||Difference in LS Mean|-27.44|||<|0.0001|TWO_SIDED|90.0|-37.03|-17.85|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.85|-37.03|<.0001
91645999|NCT03985293|183184574|SUPERIORITY||Difference in LS Mean|-27.36|||<|0.0001|TWO_SIDED|90.0|-37.22|-17.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.51|-37.22|<.0001
91646000|NCT03985293|183184574|SUPERIORITY||Difference in LS Mean|-28.09|||<|0.0001|TWO_SIDED|90.0|-37.72|-18.45|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-18.45|-37.72|<.0001
91646001|NCT03985293|183184575|SUPERIORITY||Difference in LS Mean|-15.9||||0.0091|TWO_SIDED|90.0|-25.9|-5.9|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-5.90|-25.90|0.0091
91646002|NCT03985293|183184575|SUPERIORITY||Difference in LS Mean|-25.53|||<|0.0001|TWO_SIDED|90.0|-35.18|-15.89|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.89|-35.18|<.0001
91646003|NCT03985293|183184575|SUPERIORITY||Difference in LS Mean|-30.01|||<|0.0001|TWO_SIDED|90.0|-39.8|-20.21|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.21|-39.80|<.0001
91646004|NCT03985293|183184575|SUPERIORITY||Difference in LS Mean|-27.48|||<|0.0001|TWO_SIDED|90.0|-37.63|-17.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.33|-37.63|<.0001
91519886|NCT02460692|182913743|SUPERIORITY|||||||0.14||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.14
91646005|NCT03985293|183184575|SUPERIORITY||Difference in LS Mean|-31.77|||<|0.0001|TWO_SIDED|90.0|-41.77|-21.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.78|-41.77|<.0001
91646006|NCT03985293|183184576|SUPERIORITY||Difference in LS Mean|-3.63||||0.5449|TWO_SIDED|90.0|-13.51|6.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||6.25|-13.51|0.5449
91646007|NCT03985293|183184576|SUPERIORITY||Difference in LS Mean|-17.12||||0.0031|TWO_SIDED|90.0|-26.62|-7.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-7.63|-26.62|0.0031
91646008|NCT03985293|183184576|SUPERIORITY||Difference in LS Mean|-20.64||||0.0005|TWO_SIDED|90.0|-30.31|-10.96|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-10.96|-30.31|0.0005
91646009|NCT03985293|183184576|SUPERIORITY||Difference in LS Mean|-24.12|||<|0.0001|TWO_SIDED|90.0|-34.2|-14.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.04|-34.20|<.0001
91646010|NCT03985293|183184576|SUPERIORITY||Difference in LS Mean|-25.21|||<|0.0001|TWO_SIDED|90.0|-35.44|-14.97|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.97|-35.44|<.0001
91646011|NCT03985293|183184577|SUPERIORITY||Difference in LS Mean|-7.7||||0.294|TWO_SIDED|90.0|-19.78|4.38|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||4.38|-19.78|0.2940
91646012|NCT03985293|183184577|SUPERIORITY||Difference in LS Mean|-23.77||||0.0008|TWO_SIDED|90.0|-35.37|-12.17|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-12.17|-35.37|0.0008
91646013|NCT03985293|183184577|SUPERIORITY||Difference in LS Mean|-33.23|||<|0.0001|TWO_SIDED|90.0|-45.05|-21.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.40|-45.05|<.0001
91646014|NCT03985293|183184577|SUPERIORITY||Difference in LS Mean|-31.66|||<|0.0001|TWO_SIDED|90.0|-44.14|-19.19|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-19.19|-44.14|<.0001
91646015|NCT03985293|183184577|SUPERIORITY||Difference in LS Mean|-33.59|||<|0.0001|TWO_SIDED|90.0|-46.67|-20.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.51|-46.67|<.0001
91646016|NCT03985293|183184578|SUPERIORITY||Difference in LS Mean|-14.12||||0.0464|TWO_SIDED|90.0|-25.77|-2.47|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.47|-25.77|0.0464
91646017|NCT03985293|183184578|SUPERIORITY||Difference in LS Mean|-25.84||||0.0002|TWO_SIDED|90.0|-37.05|-14.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.62|-37.05|0.0002
91646018|NCT03985293|183184578|SUPERIORITY||Difference in LS Mean|-31.78|||<|0.0001|TWO_SIDED|90.0|-43.2|-20.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.35|-43.20|<.0001
91646019|NCT03985293|183184578|SUPERIORITY||Difference in LS Mean|-27.02||||0.0002|TWO_SIDED|90.0|-39.03|-15.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.01|-39.03|0.0002
91646020|NCT03985293|183184578|SUPERIORITY||Difference in LS Mean|-33.24|||<|0.0001|TWO_SIDED|90.0|-45.63|-20.84|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.84|-45.63|<.0001
91646021|NCT03985293|183184579|SUPERIORITY||Difference in LS Mean|0.06||||0.8011|TWO_SIDED|90.0|-0.33|0.44|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.44|-0.33|0.8011
91646022|NCT03985293|183184579|SUPERIORITY||Difference in LS Mean|0.02||||0.9149|TWO_SIDED|90.0|-0.35|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.35|0.9149
91646023|NCT03985293|183184579|SUPERIORITY||Difference in LS Mean|-0.08||||0.7216|TWO_SIDED|90.0|-0.46|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.30|-0.46|0.7216
91646024|NCT03985293|183184579|SUPERIORITY||Difference in LS Mean|-0.42||||0.0758|TWO_SIDED|90.0|-0.8|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-0.80|0.0758
91646025|NCT03985293|183184579|SUPERIORITY||Difference in LS Mean|-0.4||||0.086|TWO_SIDED|90.0|-0.77|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-0.77|0.0860
91646026|NCT03985293|183184580|SUPERIORITY||Difference in LS Mean|-0.08||||0.7898|TWO_SIDED|90.0|-0.59|0.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.42|-0.59|0.7898
91646027|NCT03985293|183184580|SUPERIORITY||Difference in LS Mean|0.16||||0.5829|TWO_SIDED|90.0|-0.33|0.66|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.66|-0.33|0.5829
91646028|NCT03985293|183184580|SUPERIORITY||Difference in LS Mean|-0.52||||0.0827|TWO_SIDED|90.0|-1.02|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-1.02|0.0827
91646029|NCT03985293|183184580|SUPERIORITY||Difference in LS Mean|-0.8||||0.0101|TWO_SIDED|90.0|-1.31|-0.29|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.29|-1.31|0.0101
91646030|NCT03985293|183184580|SUPERIORITY||Difference in LS Mean|-1.09||||0.0004|TWO_SIDED|90.0|-1.59|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-1.59|0.0004
91646031|NCT03985293|183184581|SUPERIORITY||Difference in LS Mean|-0.1||||0.7985|TWO_SIDED|90.0|-0.75|0.55|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.55|-0.75|0.7985
91646032|NCT03985293|183184581|SUPERIORITY||Difference in LS Mean|-0.23||||0.5484|TWO_SIDED|90.0|-0.86|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.86|0.5484
91646033|NCT03985293|183184581|SUPERIORITY||Difference in LS Mean|-0.75||||0.0541|TWO_SIDED|90.0|-1.38|-0.11|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.11|-1.38|0.0541
91646034|NCT03985293|183184581|SUPERIORITY||Difference in LS Mean|-1.6|||<|0.0001|TWO_SIDED|90.0|-2.26|-0.95|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.95|-2.26|<.0001
91646035|NCT03985293|183184581|SUPERIORITY||Difference in LS Mean|-2.25|||<|0.0001|TWO_SIDED|90.0|-2.9|-1.6|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.60|-2.90|<.0001
91519887|NCT02460692|182913744|SUPERIORITY|||||||0.1||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||||||0.10
91646036|NCT03985293|183184582|SUPERIORITY||Difference in LS Mean|0.31||||0.4692|TWO_SIDED|90.0|-0.4|1.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.03|-0.40|0.4692
91646037|NCT03985293|183184582|SUPERIORITY||Difference in LS Mean|0.09||||0.8274|TWO_SIDED|90.0|-0.6|0.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.78|-0.60|0.8274
91646038|NCT03985293|183184582|SUPERIORITY||Difference in LS Mean|-0.72||||0.0887|TWO_SIDED|90.0|-1.42|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-1.42|0.0887
91646039|NCT03985293|183184582|SUPERIORITY||Difference in LS Mean|-1.61||||0.0003|TWO_SIDED|90.0|-2.33|-0.88|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.88|-2.33|0.0003
91646040|NCT03985293|183184582|SUPERIORITY||Difference in LS Mean|-2.95|||<|0.0001|TWO_SIDED|90.0|-3.67|-2.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.22|-3.67|<.0001
91646041|NCT03985293|183184583|SUPERIORITY||Difference in LS Mean|0.15||||0.7758|TWO_SIDED|90.0|-0.7|0.99|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.99|-0.70|0.7758
91646042|NCT03985293|183184583|SUPERIORITY||Difference in LS Mean|0.23||||0.6367|TWO_SIDED|90.0|-0.58|1.05|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.05|-0.58|0.6367
91646043|NCT03985293|183184583|SUPERIORITY||Difference in LS Mean|-0.81||||0.1082|TWO_SIDED|90.0|-1.63|0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.02|-1.63|0.1082
91646044|NCT03985293|183184583|SUPERIORITY||Difference in LS Mean|-2.28|||<|0.0001|TWO_SIDED|90.0|-3.14|-1.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.42|-3.14|<.0001
91646045|NCT03985293|183184583|SUPERIORITY||Difference in LS Mean|-3.57|||<|0.0001|TWO_SIDED|90.0|-4.44|-2.7|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.70|-4.44|<.0001
91646046|NCT03985293|183184584|SUPERIORITY||Difference in LS Mean|0.45||||0.4325|TWO_SIDED|90.0|-0.5|1.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.41|-0.50|0.4325
91646047|NCT03985293|183184584|SUPERIORITY||Difference in LS Mean|0.38||||0.4978|TWO_SIDED|90.0|-0.54|1.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.30|-0.54|0.4978
91646048|NCT03985293|183184584|SUPERIORITY||Difference in LS Mean|-0.73||||0.197|TWO_SIDED|90.0|-1.66|0.2|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.20|-1.66|0.1970
91646049|NCT03985293|183184584|SUPERIORITY||Difference in LS Mean|-2.04||||0.0006|TWO_SIDED|90.0|-3.01|-1.07|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.07|-3.01|0.0006
91646050|NCT03985293|183184584|SUPERIORITY||Difference in LS Mean|-4.17|||<|0.0001|TWO_SIDED|90.0|-5.15|-3.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-3.18|-5.15|<.0001
91646051|NCT02913261|183184632|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.65|4.22|||Stratified Cochran-Mantel-Haenszel|||||4.22|1.65|<.0001
91646052|NCT02913261|183184633|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0005|TWO_SIDED|95.0|1.43|3.94|||Stratified Cochran-Mantel-Haenszel|||||3.94|1.43|0.0005
91646053|NCT02913261|183184634|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0029|TWO_SIDED|95.0|1.24|3.17|||Stratified Cochran-Mantel-Haenszel|||||3.17|1.24|0.0029
91646054|NCT02913261|183184646|SUPERIORITY||Odds Ratio (OR)|3.07|||<|0.0001|TWO_SIDED|95.0|1.8|5.25|||Stratified Cochran-Mantel-Haenszel|||||5.25|1.80|<.0001
91646055|NCT01236053|183184659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0002|TWO_SIDED|95.0|1.07|1.24|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)"|||1.24|1.07|0.0002
91646056|NCT01236053|183184659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.0976|TWO_SIDED|95.0|0.99|1.15|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.99|0.0976
91646057|NCT01236053|183184659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.23|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)"|||1.36|1.23|<0.0001
91646058|NCT01236053|183184659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.0001|TWO_SIDED|95.0|1.13|1.26|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|1.13|<0.0001
91646059|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.1468|TWO_SIDED|95.0|0.97|1.23|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.23|0.97|0.1468
91646060|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.8545|TWO_SIDED|95.0|0.9|1.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.90|0.8545
91646061|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.27|1.48|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.48|1.27|<0.0001
91646062|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|||<|0.0001|TWO_SIDED|95.0|1.18|1.37|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.37|1.18|<0.0001
91646063|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0033|TWO_SIDED|95.0|1.07|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.43|1.07|0.0033
91646064|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0474|TWO_SIDED|95.0|1.0|1.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.33|1.00|0.0474
91707713|NCT04227405|183308942|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Plannning subscale for the control group||||>.05
91646065|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.16|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.16|<0.0001
91646066|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0008|TWO_SIDED|95.0|1.08|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.32|1.08|0.0008
91646067|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.019|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0190
91646068|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.3366|TWO_SIDED|95.0|0.94|1.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.21|0.94|0.3366
91646069|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0001|TWO_SIDED|95.0|1.09|1.31|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.31|1.09|0.0001
91646070|NCT01236053|183184660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.0464|TWO_SIDED|95.0|1.0|1.2|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.20|1.00|0.0464
91646071|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1194|TWO_SIDED|95.0|0.97|1.26|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.26|0.97|0.1194
91646072|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.7004|TWO_SIDED|95.0|0.9|1.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.90|0.7004
91646073|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.26|1.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.49|1.26|<0.0001
91646074|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||<|0.0001|TWO_SIDED|95.0|1.16|1.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.38|1.16|<0.0001
91646075|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0134|TWO_SIDED|95.0|1.03|1.34|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.34|1.03|0.0134
91707714|NCT04227405|183308942|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||<.10
91646076|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.1592|TWO_SIDED|95.0|0.96|1.25|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.25|0.96|0.1592
91646077|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.24|1.47|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.47|1.24|<0.0001
91646078|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||<|0.0001|TWO_SIDED|95.0|1.14|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.36|1.14|<0.0001
91646079|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0131|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0131
91646080|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.2731|TWO_SIDED|95.0|0.95|1.22|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.22|0.95|0.2731
91646081|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0012|TWO_SIDED|95.0|1.06|1.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.28|1.06|0.0012
91707715|NCT04227405|183308942|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Planning subscale||||>.05
91707716|NCT04227405|183308942|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
91707717|NCT04227405|183308942|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||>.05
91707718|NCT04227405|183308942|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Support subscale||||>.05
91707719|NCT04227405|183308944|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
91707720|NCT04227405|183308944|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.01
91707721|NCT04227405|183308944|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
91707722|NCT04227405|183308944|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||>.05
91707723|NCT04227405|183308944|SUPERIORITY||Slope|0.3|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.10
91707724|NCT04227405|183308944|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale||||<.05
91707725|NCT04227405|183308944|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
91707726|NCT04227405|183308944|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the Intervention group||||<.05
91707727|NCT04227405|183308944|SUPERIORITY||Slope|0.74|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
91646082|NCT01236053|183184661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.1477|TWO_SIDED|95.0|0.98|1.17|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.98|0.1477
91646083|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0369|TWO_SIDED|95.0|1.01|1.41|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||1.41|1.01|0.0369
91707728|NCT04227405|183308944|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
91707729|NCT04227405|183308944|SUPERIORITY||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||<.01
91707730|NCT04227405|183308944|SUPERIORITY||Slope|0.6|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||<.01
91707731|NCT04227405|183308945|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||>.05
91707732|NCT04227405|183308945|SUPERIORITY||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.01
91707733|NCT04227405|183308945|SUPERIORITY||Slope|0.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Acceptance subscale|The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|||<.01
91707734|NCT04227405|183308945|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||>.05
91707735|NCT04227405|183308945|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.10
91707736|NCT04227405|183308945|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.1|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.10
91707737|NCT04227405|183308945|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
91707738|NCT04227405|183308945|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
91707739|NCT04227405|183308945|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.01
91707740|NCT04227405|183308945|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
91707741|NCT04227405|183308945|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.01
91707742|NCT04227405|183308945|SUPERIORITY||Slope|0.66|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||<.01
91707743|NCT04227405|183308945|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
91707744|NCT04227405|183308945|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the interventionn group||||>.05
91707745|NCT04227405|183308945|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Acceptance subscale||||>.05
91707746|NCT04227405|183308945|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the control group||||>.05
91707747|NCT04227405|183308945|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping in the intervention group||||>.05
91707748|NCT04227405|183308945|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Coping subscale||||>.05
91519888|NCT02460692|182913744|SUPERIORITY|||||||0.67||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.67
91519889|NCT02460692|182913744|SUPERIORITY|||||||0.25||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.25
91707749|NCT04227405|183308945|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the control group||||>.05
91707750|NCT04227405|183308945|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||>.05
91707751|NCT04227405|183308945|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in Planning subscale||||>.05
91707752|NCT04227405|183308945|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
91707753|NCT04227405|183308945|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.10
91707754|NCT04227405|183308945|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Supportt subscale||||>.05
91707755|NCT04227405|183308947|SUPERIORITY||Slope|-1.41|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Multilevel modeling|||Changes from pre-test to posttest for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
91707756|NCT04227405|183308947|SUPERIORITY||Slope|2.02|STANDARD_ERROR_OF_MEAN|0.69|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest for the intervention group||||<.01
91707757|NCT04227405|183308947|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.83|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test t in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
91707758|NCT04227405|183308948|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the control group||||>.05
91707759|NCT04227405|183308948|SUPERIORITY||Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.82|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the intervention group||||<.10
91707760|NCT04227405|183308948|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|1.01|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up||||>.05
91707761|NCT04227405|183308948|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
91707762|NCT04227405|183308948|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
91707763|NCT04227405|183308948|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up||||>.05
91707764|NCT04227405|183308950|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|1.16|>|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Difficulties in Emotion Regulation for the control group||||>.05
91707765|NCT04227405|183308950|SUPERIORITY||Slope|-3.07|STANDARD_ERROR_OF_MEAN|1.51|<|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
91707766|NCT04227405|183308950|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.85|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
91707767|NCT04227405|183308951|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|1.41|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Change from pre-test to follow-up for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
91707768|NCT04227405|183308951|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.79|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||>.05
91707769|NCT04227405|183308951|SUPERIORITY||Slope|-2.04|STANDARD_ERROR_OF_MEAN|2.24|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||>.05
91707770|NCT04227405|183308951|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
91707771|NCT04227405|183308951|SUPERIORITY||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
91707772|NCT04227405|183308951|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.68|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
91707773|NCT04227405|183308953|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological agggression subscale for the control group||||<.001
91707774|NCT04227405|183308953|SUPERIORITY||Slope|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological aggression subscale for the intervention group||||<.001
91707775|NCT04227405|183308953|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Psychological Aggression subscale||||<.10
91707776|NCT04227405|183308953|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to post-test in physical assault subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
91707777|NCT04227405|183308953|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the physical assault subscale for the intervention group||||<.001
91707778|NCT04227405|183308953|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Physical Assault subscale||||<.05
91707779|NCT04227405|183308954|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the psychological aggression subscale for the control group||||<.001
91707780|NCT04227405|183308954|SUPERIORITY||Slope|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Psychological Aggression subscale for the intervention group||||<.001
91707781|NCT04227405|183308954|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.21|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn the psychological aggression subscale||||>.05
91707782|NCT04227405|183308954|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group in the psychological aggression subscale||||<.10
91707783|NCT04227405|183308954|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the psychological aggresssion subscale||||>.05
91707784|NCT04227405|183308954|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the psychological aggression subscale||||>.05
91772242|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0046|TWO_SIDED|95.0|1.67|16.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.68|1.67|0.0046
91772243|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3788|TWO_SIDED|95.0|0.57|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.34|0.57|0.3788
91707785|NCT04227405|183308954|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the physical assault subscale||||>.05
91707786|NCT04227405|183308954|SUPERIORITY||Slope|-0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Physical Assault Subscale||||<.05
91772244|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0424|TWO_SIDED|95.0|1.04|7.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.70|1.04|0.0424
91772245|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0139|TWO_SIDED|95.0|1.3|10.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.43|1.30|0.0139
91772246|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3057|TWO_SIDED|95.0|0.63|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.63|0.3057
91772247|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3717|TWO_SIDED|95.0|0.59|4.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.02|0.59|0.3717
91772248|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0252|TWO_SIDED|95.0|1.16|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.50|1.16|0.0252
91772249|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0235|TWO_SIDED|95.0|1.19|10.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.69|1.19|0.0235
91772250|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.25||||0.658|TWO_SIDED|95.0|0.46|3.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.39|0.46|0.6580
91772251|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0061|TWO_SIDED|95.0|1.54|13.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.62|1.54|0.0061
91772252|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0149|TWO_SIDED|95.0|1.29|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.61|1.29|0.0149
91519890|NCT02460692|182913745|SUPERIORITY|||||||0.84||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.84
91772253|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9282|TWO_SIDED|95.0|0.35|2.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.62|0.35|0.9282
91772254|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7902|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.7902
91772255|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1603|TWO_SIDED|95.0|0.73|6.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.74|0.73|0.1603
91772256|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1144|TWO_SIDED|95.0|0.8|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.14|0.80|0.1144
91772257|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5903|TWO_SIDED|95.0|0.26|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.13|0.26|0.5903
91772258|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.89||||0.029|TWO_SIDED|95.0|1.15|13.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.16|1.15|0.0290
91772259|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1721|TWO_SIDED|95.0|0.72|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.26|0.72|0.1721
91772260|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2439|TWO_SIDED|95.0|0.66|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.66|0.2439
91772261|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7402|TWO_SIDED|95.0|0.44|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.19|0.44|0.7402
91772262|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0422|TWO_SIDED|95.0|1.04|9.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.63|1.04|0.0422
91772263|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0061|TWO_SIDED|95.0|1.62|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.27|1.62|0.0061
91772264|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3191|TWO_SIDED|95.0|0.59|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.92|0.59|0.3191
91772265|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.91||||0.0037|TWO_SIDED|95.0|1.78|19.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.66|1.78|0.0037
91772266|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0139|TWO_SIDED|95.0|1.33|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.20|1.33|0.0139
91772267|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.59||||0.3757|TWO_SIDED|95.0|0.57|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.42|0.57|0.3757
91772268|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7087|TWO_SIDED|95.0|0.45|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.28|0.45|0.7087
91772269|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1083|TWO_SIDED|95.0|0.81|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.88|0.81|0.1083
91772270|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0473|TWO_SIDED|95.0|1.01|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.14|1.01|0.0473
91772271|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2481|TWO_SIDED|95.0|0.64|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.64|0.2481
91772272|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|5.84||||0.0066|TWO_SIDED|95.0|1.64|20.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.89|1.64|0.0066
91772273|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0466|TWO_SIDED|95.0|1.02|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.18|1.02|0.0466
91772274|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8769|TWO_SIDED|95.0|0.34|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.53|0.34|0.8769
91772275|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5448|TWO_SIDED|95.0|0.49|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.82|0.49|0.5448
91772276|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.57||||0.4125|TWO_SIDED|95.0|0.53|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.64|0.53|0.4125
91772277|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.36||||0.05|TWO_SIDED|95.0|1.0|11.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.30|1.00|0.0500
91772278|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6167|TWO_SIDED|95.0|0.45|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.87|0.45|0.6167
91772279|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0233|TWO_SIDED|95.0|1.21|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.26|1.21|0.0233
91772280|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0803|TWO_SIDED|95.0|0.89|8.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.09|0.89|0.0803
91772281|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1274|TWO_SIDED|95.0|0.76|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.18|0.76|0.1274
91772282|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.05||||0.9445|TWO_SIDED|95.0|0.29|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.71|0.29|0.9445
91772283|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4204|TWO_SIDED|95.0|0.47|6.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.03|0.47|0.4204
91772284|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.78||||0.1315|TWO_SIDED|95.0|0.74|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.49|0.74|0.1315
91772285|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0944|TWO_SIDED|95.0|0.82|12.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.87|0.82|0.0944
91772286|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2801|TWO_SIDED|95.0|0.57|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.89|0.57|0.2801
91772287|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1524|TWO_SIDED|95.0|0.72|8.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.30|0.72|0.1524
91772288|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6129|TWO_SIDED|95.0|0.4|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.75|0.40|0.6129
91772289|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4617|TWO_SIDED|95.0|0.18|2.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.18|0.18|0.4617
91772290|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6519|TWO_SIDED|95.0|0.2|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.70|0.20|0.6519
91772291|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8011|TWO_SIDED|95.0|0.22|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.22|0.8011
91772292|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3254|TWO_SIDED|95.0|0.51|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.41|0.51|0.3254
91772293|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|2.0||||0.273|TWO_SIDED|95.0|0.58|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.94|0.58|0.2730
91772294|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6601|TWO_SIDED|95.0|0.39|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.41|0.39|0.6601
91772295|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6588|TWO_SIDED|95.0|0.2|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.76|0.20|0.6588
91772296|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3257|TWO_SIDED|95.0|0.14|1.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.92|0.14|0.3257
91772297|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.42||||0.2229|TWO_SIDED|95.0|0.1|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.10|0.2229
91772298|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2425|TWO_SIDED|95.0|0.1|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.10|0.2425
91772299|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9672|TWO_SIDED|95.0|0.23|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.11|0.23|0.9672
91772300|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5838|TWO_SIDED|95.0|0.4|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.09|0.40|0.5838
91772301|NCT03192176|183427592|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9361|TWO_SIDED|95.0|0.28|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.28|0.9361
91772302|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0429|TWO_SIDED|95.0|1.03|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.55|1.03|0.0429
91772303|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0296|TWO_SIDED|95.0|1.11|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.12|1.11|0.0296
91772304|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0032|TWO_SIDED|95.0|1.65|12.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.13|1.65|0.0032
91772305|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0006|TWO_SIDED|95.0|2.31|21.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.90|2.31|0.0006
91772306|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2073|TWO_SIDED|95.0|0.72|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.47|0.72|0.2073
91772307|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0096|TWO_SIDED|95.0|1.36|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.36|0.0096
91772308|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0462|TWO_SIDED|95.0|1.02|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.27|1.02|0.0462
91772309|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1387|TWO_SIDED|95.0|0.77|6.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.63|0.77|0.1387
91772310|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.71||||0.313|TWO_SIDED|95.0|0.6|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.84|0.60|0.3130
91772311|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0392|TWO_SIDED|95.0|1.06|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.40|1.06|0.0392
91772312|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0135|TWO_SIDED|95.0|1.43|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.71|1.43|0.0135
91772313|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.85||||0.084|TWO_SIDED|95.0|0.87|9.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.36|0.87|0.0840
91772314|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.47||||0.0163|TWO_SIDED|95.0|1.32|15.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.17|1.32|0.0163
91772315|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5056|TWO_SIDED|95.0|0.52|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||3.84|0.52|0.5056
91772316|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.69||||0.3358|TWO_SIDED|95.0|0.58|4.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.90|0.58|0.3358
91772317|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0696|TWO_SIDED|95.0|0.91|10.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.18|0.91|0.0696
91772318|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0794|TWO_SIDED|95.0|0.89|8.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.82|0.89|0.0794
91772319|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.32||||0.0149|TWO_SIDED|95.0|1.48|36.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.28|1.48|0.0149
91772320|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.37||||0.0377|TWO_SIDED|95.0|1.09|17.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.59|1.09|0.0377
91772321|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0454|TWO_SIDED|95.0|1.03|10.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.77|1.03|0.0454
91772322|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.77||||0.039|TWO_SIDED|95.0|1.07|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.26|1.07|0.0390
91772323|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1947|TWO_SIDED|95.0|0.68|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.64|0.68|0.1947
91772324|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2913|TWO_SIDED|95.0|0.61|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.25|0.61|0.2913
91772325|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1665|TWO_SIDED|95.0|0.72|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.82|0.72|0.1665
91772326|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|13.41||||0.0157|TWO_SIDED|95.0|1.63|110.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||110.3|1.63|0.0157
91772327|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0846|TWO_SIDED|95.0|0.86|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.49|0.86|0.0846
91772328|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0171|TWO_SIDED|95.0|1.35|21.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||21.75|1.35|0.0171
91772329|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0262|TWO_SIDED|95.0|1.2|18.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.49|1.20|0.0262
91772330|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2858|TWO_SIDED|95.0|0.59|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.95|0.59|0.2858
91772331|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0155|TWO_SIDED|95.0|1.47|39.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||39.72|1.47|0.0155
91772332|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.66||||0.1249|TWO_SIDED|95.0|0.76|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.31|0.76|0.1249
91772333|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0616|TWO_SIDED|95.0|0.94|15.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.82|0.94|0.0616
91772334|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|8.32||||0.0126|TWO_SIDED|95.0|1.58|43.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||43.90|1.58|0.0126
91772335|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0853|TWO_SIDED|95.0|0.85|11.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.23|0.85|0.0853
91772336|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1562|TWO_SIDED|95.0|0.7|9.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.35|0.70|0.1562
91772337|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1297|TWO_SIDED|95.0|0.74|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.91|0.74|0.1297
91772338|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.34||||0.2001|TWO_SIDED|95.0|0.64|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.64|0.2001
91772339|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0495|TWO_SIDED|95.0|1.0|73.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||73.70|1.00|0.0495
91772340|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1553|TWO_SIDED|95.0|0.67|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.20|0.67|0.1553
91772341|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.67||||0.0199|TWO_SIDED|95.0|1.38|42.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||42.67|1.38|0.0199
91772342|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0472|TWO_SIDED|95.0|1.02|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.34|1.02|0.0472
91772343|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3736|TWO_SIDED|95.0|0.51|5.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.98|0.51|0.3736
91772344|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2628|TWO_SIDED|95.0|0.58|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.26|0.58|0.2628
91772345|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1998|TWO_SIDED|95.0|0.63|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.39|0.63|0.1998
91772346|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.89||||0.1507|TWO_SIDED|95.0|0.68|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.28|0.68|0.1507
91772347|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.92||||0.0385|TWO_SIDED|95.0|1.1|31.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||31.94|1.10|0.0385
91772348|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|10.85||||0.0299|TWO_SIDED|95.0|1.26|93.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||93.28|1.26|0.0299
91772349|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.19||||0.8034|TWO_SIDED|95.0|0.3|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.74|0.30|0.8034
91772350|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8532|TWO_SIDED|95.0|0.29|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.29|0.8532
91772351|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8823|TWO_SIDED|95.0|0.28|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.41|0.28|0.8823
91772352|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.79||||0.1651|TWO_SIDED|95.0|0.52|43.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||43.76|0.52|0.1651
91772353|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|6.36||||0.1048|TWO_SIDED|95.0|0.68|59.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||59.55|0.68|0.1048
91772354|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.87||||0.1168|TWO_SIDED|95.0|0.64|53.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.53|0.64|0.1168
91772355|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6936|TWO_SIDED|95.0|0.35|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.95|0.35|0.6936
91772356|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4315|TWO_SIDED|95.0|0.44|6.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.90|0.44|0.4315
91772357|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7936|TWO_SIDED|95.0|0.31|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.53|0.31|0.7936
91772358|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|6.3||||0.099|TWO_SIDED|95.0|0.71|56.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||56.03|0.71|0.0990
91772359|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.86||||0.1128|TWO_SIDED|95.0|0.66|52.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||52.21|0.66|0.1128
91772360|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0732|TWO_SIDED|95.0|0.83|65.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||65.38|0.83|0.0732
91772361|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.39||||0.6559|TWO_SIDED|95.0|0.33|5.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.91|0.33|0.6559
91772362|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7333|TWO_SIDED|95.0|0.21|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.96|0.21|0.7333
91772363|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9266|TWO_SIDED|95.0|0.24|3.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.74|0.24|0.9266
91772364|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.04||||0.1518|TWO_SIDED|95.0|0.55|46.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.13|0.55|0.1518
91772365|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.69||||0.1714|TWO_SIDED|95.0|0.51|42.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||42.91|0.51|0.1714
91772366|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.6||||0.1299|TWO_SIDED|95.0|0.6|51.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||51.95|0.60|0.1299
91772367|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.75||||0.2495|TWO_SIDED|95.0|0.49|15.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.44|0.49|0.2495
91772368|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.32||||0.7065|TWO_SIDED|95.0|0.31|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.31|0.7065
91772369|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7504|TWO_SIDED|95.0|0.3|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.24|0.30|0.7504
91772370|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7862|TWO_SIDED|95.0|0.21|3.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.29|0.21|0.7862
91772371|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.98||||0.155|TWO_SIDED|95.0|0.54|45.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.59|0.54|0.1550
91519891|NCT02460692|182913745|SUPERIORITY|||||||0.91||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.91
91772372|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.7||||0.1706|TWO_SIDED|95.0|0.51|42.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.96|0.51|0.1706
91772373|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.31||||0.1415|TWO_SIDED|95.0|0.57|49.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||49.11|0.57|0.1415
91772374|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.67||||0.1241|TWO_SIDED|95.0|0.62|51.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.74|0.62|0.1241
91772375|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.64||||0.2169|TWO_SIDED|95.0|0.57|12.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.29|0.57|0.2169
91772376|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9982|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.60|0.28|0.9982
91772377|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.57||||0.5364|TWO_SIDED|95.0|0.38|6.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.54|0.38|0.5364
91772378|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.68||||0.121|TWO_SIDED|95.0|0.63|51.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||51.07|0.63|0.1210
91772379|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0726|TWO_SIDED|95.0|0.83|70.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||70.58|0.83|0.0726
91772380|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0749|TWO_SIDED|95.0|0.82|65.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||65.81|0.82|0.0749
91772381|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.01||||0.053|TWO_SIDED|95.0|0.98|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.35|0.98|0.0530
91772382|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.32||||0.2134|TWO_SIDED|95.0|0.62|8.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.72|0.62|0.2134
91772383|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3688|TWO_SIDED|95.0|0.48|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.41|0.48|0.3688
91772384|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|4.61||||0.0563|TWO_SIDED|95.0|0.96|22.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.11|0.96|0.0563
91772385|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0935|TWO_SIDED|95.0|0.79|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.52|0.79|0.0935
91772386|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0901|TWO_SIDED|95.0|0.81|16.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.93|0.81|0.0901
91772387|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1366|TWO_SIDED|95.0|0.72|11.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.26|0.72|0.1366
91772388|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7876|TWO_SIDED|95.0|0.34|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.08|0.34|0.7876
91772389|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4658|TWO_SIDED|95.0|0.45|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.59|0.45|0.4658
91519892|NCT02460692|182913745|SUPERIORITY|||||||0.75||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.75
91772390|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8707|TWO_SIDED|95.0|0.25|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.20|0.25|0.8707
91772391|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3584|TWO_SIDED|95.0|0.49|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.36|0.49|0.3584
91772392|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|3.13||||0.1455|TWO_SIDED|95.0|0.67|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.57|0.67|0.1455
91772393|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0661|TWO_SIDED|95.0|0.9|28.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||28.66|0.90|0.0661
91772394|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.97||||0.3034|TWO_SIDED|95.0|0.54|7.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.17|0.54|0.3034
91772395|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9901|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.60|0.28|0.9901
91772396|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.55||||0.507|TWO_SIDED|95.0|0.42|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.68|0.42|0.5070
91772397|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7927|TWO_SIDED|95.0|0.21|3.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.26|0.21|0.7927
91519893|NCT02460692|182913746|SUPERIORITY|||||||0.24||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.24
91519894|NCT02460692|182913746|SUPERIORITY|||||||0.08||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.080
91519895|NCT02460692|182913746|SUPERIORITY|||||||0.005||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.005
91772398|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4426|TWO_SIDED|95.0|0.44|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.69|0.44|0.4426
91772399|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8925|TWO_SIDED|95.0|0.23|3.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.56|0.23|0.8925
91772400|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4285|TWO_SIDED|95.0|0.42|7.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.52|0.42|0.4285
91772401|NCT03192176|183427593|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.31|3.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.72|0.31|0.9000
91772402|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0602|TWO_SIDED|95.0|0.96|6.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.06|0.96|0.0602
91772403|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|4.88||||0.001|TWO_SIDED|95.0|1.89|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.57|1.89|0.0010
91772404|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|5.24||||0.0006|TWO_SIDED|95.0|2.03|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.51|2.03|0.0006
91772405|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|9.07|||<|0.0001|TWO_SIDED|95.0|3.23|25.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.45|3.23|<0.0001
91772406|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1259|TWO_SIDED|95.0|0.82|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.22|0.82|0.1259
91519896|NCT02460692|182913747|SUPERIORITY|||||||0.6|||||||unstructured covariance model|||||||0.60
91519897|NCT02460692|182913747|SUPERIORITY|||||||0.4|||||||unstructured covariance model|||||||0.40
91772407|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|7.05|||<|0.0001|TWO_SIDED|95.0|2.65|18.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.71|2.65|<0.0001
91772408|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.51||||0.007|TWO_SIDED|95.0|1.41|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.76|1.41|0.0070
91772409|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0193|TWO_SIDED|95.0|1.2|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.23|1.20|0.0193
91772410|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0148|TWO_SIDED|95.0|1.27|8.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.81|1.27|0.0148
91772411|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.94|1.83|0.0018
91772412|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|7.27||||0.0007|TWO_SIDED|95.0|2.32|22.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.78|2.32|0.0007
91772413|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0246|TWO_SIDED|95.0|1.16|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.35|1.16|0.0246
91772414|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0016|TWO_SIDED|95.0|1.87|14.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.60|1.87|0.0016
91519898|NCT02460692|182913747|SUPERIORITY|||||||0.72|||||||unstructured covariance model|||||||0.72
91519899|NCT02460692|182913748|SUPERIORITY|||||||0.19||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.19
91519900|NCT02460692|182913748|SUPERIORITY|||||||0.7||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.70
91772415|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0825|TWO_SIDED|95.0|0.9|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.62|0.90|0.0825
91772416|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0542|TWO_SIDED|95.0|0.98|7.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.20|0.98|0.0542
91772417|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0837|TWO_SIDED|95.0|0.89|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.33|0.89|0.0837
91772418|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0131|TWO_SIDED|95.0|1.31|10.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.26|1.31|0.0131
91772419|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|9.34||||0.0012|TWO_SIDED|95.0|2.41|36.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.19|2.41|0.0012
91772420|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0359|TWO_SIDED|95.0|1.08|8.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.93|1.08|0.0359
91772421|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0019|TWO_SIDED|95.0|1.91|17.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.92|1.91|0.0019
91772422|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0715|TWO_SIDED|95.0|0.93|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|0.93|0.0715
91772423|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0465|TWO_SIDED|95.0|1.02|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.20|1.02|0.0465
91772424|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0839|TWO_SIDED|95.0|0.89|6.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.53|0.89|0.0839
91772425|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0191|TWO_SIDED|95.0|1.23|10.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.28|1.23|0.0191
91772426|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|12.11||||0.0019|TWO_SIDED|95.0|2.52|58.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||58.22|2.52|0.0019
91772427|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0593|TWO_SIDED|95.0|0.96|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.90|0.96|0.0593
91772428|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0048|TWO_SIDED|95.0|1.63|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.04|1.63|0.0048
91772429|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0494|TWO_SIDED|95.0|1.0|7.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.57|1.00|0.0494
91772430|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1887|TWO_SIDED|95.0|0.69|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.70|0.69|0.1887
91772431|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0717|TWO_SIDED|95.0|0.91|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.7|0.91|0.0717
91772432|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1419|TWO_SIDED|95.0|0.74|7.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.92|0.74|0.1419
91772433|NCT03192176|183427594|SUPERIORITY|0.0141|Odds Ratio (OR)|14.37||||0.0141|TWO_SIDED|95.0|1.71|120.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||120.6|1.71|0.0141
91772434|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0775|TWO_SIDED|95.0|0.88|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.54|0.88|0.0775
91772435|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0283|TWO_SIDED|95.0|1.17|16.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.19|1.17|0.0283
91772436|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1767|TWO_SIDED|95.0|0.7|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.96|0.70|0.1767
91772437|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1675|TWO_SIDED|95.0|0.72|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.72|0.72|0.1675
91772438|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2717|TWO_SIDED|95.0|0.62|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.49|0.62|0.2717
91772439|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1367|TWO_SIDED|95.0|0.76|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.64|0.76|0.1367
91772440|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|13.53||||0.0162|TWO_SIDED|95.0|1.62|113.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||113.0|1.62|0.0162
91772441|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0765|TWO_SIDED|95.0|0.88|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.78|0.88|0.0765
91519901|NCT02460692|182913748|SUPERIORITY|||||||0.36||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.36
91772442|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|7.8||||0.0061|TWO_SIDED|95.0|1.79|33.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.87|1.79|0.0061
91772443|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0181|TWO_SIDED|95.0|1.33|21.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.85|1.33|0.0181
91772444|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3925|TWO_SIDED|95.0|0.53|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.99|0.53|0.3925
91772445|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.66||||0.374|TWO_SIDED|95.0|0.54|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.12|0.54|0.3740
91772446|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1753|TWO_SIDED|95.0|0.69|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.93|0.69|0.1753
91772447|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|12.85||||0.0195|TWO_SIDED|95.0|1.51|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||109.5|1.51|0.0195
91772448|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1932|TWO_SIDED|95.0|0.66|8.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.02|0.66|0.1932
91772449|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0537|TWO_SIDED|95.0|0.98|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.86|0.98|0.0537
91772450|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|7.72||||0.0144|TWO_SIDED|95.0|1.5|39.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||39.66|1.50|0.0144
91772451|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.29||||0.666|TWO_SIDED|95.0|0.41|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.09|0.41|0.6660
91772452|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7923|TWO_SIDED|95.0|0.37|3.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.62|0.37|0.7923
91772453|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.73||||0.3796|TWO_SIDED|95.0|0.51|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.90|0.51|0.3796
91772454|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0874|TWO_SIDED|95.0|0.81|21.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.73|0.81|0.0874
91772455|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1925|TWO_SIDED|95.0|0.62|10.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.96|0.62|0.1925
91772456|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0651|TWO_SIDED|95.0|0.92|17.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.38|0.92|0.0651
91519902|NCT02460692|182913749|SUPERIORITY|||||||0.14|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.14
91772457|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5361|TWO_SIDED|95.0|0.44|4.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.81|0.44|0.5361
91772458|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6258|TWO_SIDED|95.0|0.42|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.17|0.42|0.6258
91772459|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6275|TWO_SIDED|95.0|0.43|4.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.06|0.43|0.6275
91772460|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2212|TWO_SIDED|95.0|0.62|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.90|0.62|0.2212
91772461|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|11.13||||0.028|TWO_SIDED|95.0|1.3|95.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||95.49|1.30|0.0280
91772462|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|4.88||||0.0589|TWO_SIDED|95.0|0.94|25.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.32|0.94|0.0589
91519903|NCT02460692|182913749|SUPERIORITY|||||||0.6|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.60
91772463|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0799|TWO_SIDED|95.0|0.86|15.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.39|0.86|0.0799
91772464|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1112|TWO_SIDED|95.0|0.78|10.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.87|0.78|0.1112
91772465|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0959|TWO_SIDED|95.0|0.84|9.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.11|0.84|0.0959
91772466|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.62||||0.3886|TWO_SIDED|95.0|0.54|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.85|0.54|0.3886
91772467|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0864|TWO_SIDED|95.0|0.85|10.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.52|0.85|0.0864
91772468|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|14.22||||0.0145|TWO_SIDED|95.0|1.69|119.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||119.5|1.69|0.0145
91772469|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|13.08||||0.018|TWO_SIDED|95.0|1.56|110.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||110.0|1.56|0.0180
91772470|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|18.53||||0.008|TWO_SIDED|95.0|2.14|160.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||160.6|2.14|0.0080
91772471|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0236|TWO_SIDED|95.0|1.24|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.65|1.24|0.0236
91519904|NCT02460692|182913749|SUPERIORITY|||||||0.34|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.34
91772472|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4303|TWO_SIDED|0.4303|0.5|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.07|0.50|0.4303
91772473|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5529|TWO_SIDED|95.0|0.45|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.39|0.45|0.5529
91772474|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3268|TWO_SIDED|95.0|0.53|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.55|0.53|0.3268
91519905|NCT02460692|182913750|SUPERIORITY|||||||0.34|||||||unstructured covariance model|||||||0.34
91519906|NCT02460692|182913750|SUPERIORITY|||||||0.007|||||||unstructured covariance model|||||||0.007
91772475|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|10.02||||0.0343|TWO_SIDED|95.0|1.19|84.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||84.66|1.19|0.0343
91772476|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|9.45||||0.0391|TWO_SIDED|95.0|1.12|79.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||79.82|1.12|0.0391
91772477|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|13.31||||0.0187|TWO_SIDED|95.0|1.54|115.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||115.1|1.54|0.0187
91772478|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1475|TWO_SIDED|95.0|0.71|9.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.47|0.71|0.1475
91772479|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2161|TWO_SIDED|95.0|0.63|7.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.55|0.63|0.2161
91519907|NCT02460692|182913750|SUPERIORITY|||||||0.055|||||||unstructured covariance model|||||||0.055
91519908|NCT02460692|182913751|SUPERIORITY|||||||0.69|||||||unstructured covariance model|||||||0.69
91772480|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.79||||0.3478|TWO_SIDED|95.0|0.53|6.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.04|0.53|0.3478
91772481|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2269|TWO_SIDED|95.0|0.61|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.14|0.61|0.2269
91772482|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0683|TWO_SIDED|95.0|0.89|24.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.35|0.89|0.0683
91772483|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0228|TWO_SIDED|95.0|1.31|38.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||38.49|1.31|0.0228
91772484|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.95||||0.062|TWO_SIDED|95.0|0.93|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.72|0.93|0.0620
91772485|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.18||||0.2251|TWO_SIDED|95.0|0.62|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.62|0.2251
91772486|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7908|TWO_SIDED|95.0|0.35|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.99|0.35|0.7908
91772487|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3735|TWO_SIDED|95.0|0.48|7.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.06|0.48|0.3735
91772488|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1856|TWO_SIDED|95.0|0.64|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.64|0.1856
91772489|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.67||||0.01798|TWO_SIDED|95.0|0.64|11.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.20|0.64|0.01798
91772490|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.19||||0.1101|TWO_SIDED|95.0|0.77|13.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||13.22|0.77|0.1101
91772491|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|2.99||||0.106|TWO_SIDED|95.0|0.79|11.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.31|0.79|0.1060
91519909|NCT02460692|182913751|SUPERIORITY|||||||0.79|||||||unstructured covariance model|||||||0.79
91772492|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5258|TWO_SIDED|95.0|0.45|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.86|0.45|0.5258
91519910|NCT02460692|182913751|SUPERIORITY|||||||0.97|||||||unstructured covariance model|||||||0.97
91772493|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8746|TWO_SIDED|95.0|0.34|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.50|0.34|0.8746
91772494|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7434|TWO_SIDED|95.0|0.24|2.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.77|0.24|0.7434
91772495|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.9||||0.3211|TWO_SIDED|95.0|0.53|6.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.80|0.53|0.3211
91772496|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.51||||0.533|TWO_SIDED|95.0|0.41|5.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.48|0.41|0.5330
91772497|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|3.0||||0.1119|TWO_SIDED|95.0|0.77|11.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.64|0.77|0.1119
91519911|NCT02460692|182913752|SUPERIORITY|||||||0.21||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.21
91519912|NCT02460692|182913752|SUPERIORITY|||||||0.029||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.029
91707787|NCT04227405|183308954|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Physical Assault subscale||||<.05
91707788|NCT04227405|183308954|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group for the Physical Assault subscale||||>.05
91707789|NCT04227405|183308954|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the Physical Assault subscale||||>.05
91707790|NCT04227405|183308954|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
91707791|NCT04227405|183308956|SUPERIORITY||Slope|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group||||<.001
91707792|NCT04227405|183308956|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.001
91707793|NCT04227405|183308956|SUPERIORITY||Slope|-2.34|STANDARD_ERROR_OF_MEAN|0.89|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time||||<.05
91707794|NCT04227405|183308957|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.7|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||<.05
91707795|NCT04227405|183308957|SUPERIORITY||Slope|-4.48|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group||||<.001
91707796|NCT04227405|183308957|SUPERIORITY||Slope|-2.52|STANDARD_ERROR_OF_MEAN|1.1|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||<.05
91707797|NCT04227405|183308957|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
91707798|NCT04227405|183308957|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
91707799|NCT04227405|183308957|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
91707800|NCT04227405|183308959|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for Supportive Dyadic Coping subscale||||>.05
91707801|NCT04227405|183308959|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.31|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
91707802|NCT04227405|183308959|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.38|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Supportive Dyadic Coping subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
91707803|NCT04227405|183308959|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.3|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the common dyadic coping subscale||||>.05
91772498|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.76||||0.354|TWO_SIDED|95.0|0.53|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.85|0.53|0.3540
91772499|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5076|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.29|0.19|0.5076
91772500|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5801|TWO_SIDED|95.0|0.21|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.21|0.5801
91772501|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2785|TWO_SIDED|95.0|0.13|1.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.82|0.13|0.2785
91772502|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5656|TWO_SIDED|95.0|0.19|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.45|0.19|0.5656
91772503|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6445|TWO_SIDED|95.0|0.19|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.81|0.19|0.6445
91772504|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|1.27||||0.7363|TWO_SIDED|95.0|0.32|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.99|0.32|0.7363
91772505|NCT03192176|183427594|SUPERIORITY||Odds Ratio (OR)|0.56||||0.3455|TWO_SIDED|95.0|0.17|1.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.86|0.17|0.3455
91772506|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0037|TWO_SIDED|95.0|1.6|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.54|1.60|0.0037
91519913|NCT02460692|182913752|SUPERIORITY|||||||0.001||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.001
91772507|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.95||||0.0057|TWO_SIDED|95.0|1.49|10.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.48|1.49|0.0057
91772508|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.26|16.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.13|2.26|0.0003
91772509|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.37|17.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.39|2.37|0.0003
91772510|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.11||||0.141|TWO_SIDED|95.0|0.78|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.73|0.78|0.1410
91772511|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0004|TWO_SIDED|95.0|2.2|15.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.55|2.20|0.0004
91772512|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0006|TWO_SIDED|95.0|2.08|14.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.54|2.08|0.0006
91772513|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0037|TWO_SIDED|95.0|1.58|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.57|1.58|0.0037
91772514|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0026|TWO_SIDED|95.0|1.67|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.16|1.67|0.0026
91519914|NCT02460692|182913753|SUPERIORITY|||||||0.084|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.084
91772515|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0002|TWO_SIDED|95.0|2.63|16.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.60|2.63|0.0002
91772516|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|9.4|||<|0.0001|TWO_SIDED|95.0|3.23|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||27.34|3.23|<0.0001
91772517|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0431|TWO_SIDED|95.0|1.03|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.76|1.03|0.0431
91772518|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.72|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.29|1.72|0.0020
91772519|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0291|TWO_SIDED|95.0|1.11|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.86|1.11|0.0291
91772520|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0063|TWO_SIDED|95.0|1.48|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.61|1.48|0.0063
91772521|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0202|TWO_SIDED|95.0|1.19|8.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.11|1.19|0.0202
91772522|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.1||||0.0044|TWO_SIDED|95.0|1.55|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.84|1.55|0.0044
91772523|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|9.21||||0.0002|TWO_SIDED|95.0|2.89|29.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||29.38|2.89|0.0002
91519915|NCT02460692|182913753|SUPERIORITY|||||||0.98|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.98
91772524|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0706|TWO_SIDED|95.0|0.93|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.37|0.93|0.0706
91772525|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0001|TWO_SIDED|95.0|2.79|24.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.08|2.79|0.0001
91772526|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0146|TWO_SIDED|95.0|1.26|8.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.32|1.26|0.0146
91772527|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0816|TWO_SIDED|95.0|0.9|6.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.24|0.90|0.0816
91772528|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.25||||0.093|TWO_SIDED|95.0|0.87|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.81|0.87|0.0930
91772529|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.81||||0.365|TWO_SIDED|95.0|1.07|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.39|1.07|0.365
91772530|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.93||||0.0042|TWO_SIDED|95.0|1.65|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.73|1.65|0.0042
91772531|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0488|TWO_SIDED|95.0|1.01|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.41|1.01|0.0488
91772532|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0075|TWO_SIDED|95.0|1.43|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.36|1.43|0.0075
91772533|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0984|TWO_SIDED|95.0|0.86|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.59|0.86|0.0984
91772534|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2226|TWO_SIDED|95.0|0.68|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.29|0.68|0.2226
91772535|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1467|TWO_SIDED|95.0|0.76|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.08|0.76|0.1467
91772536|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0705|TWO_SIDED|95.0|0.92|8.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.19|0.92|0.0705
91772537|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|26.62||||0.0025|TWO_SIDED|95.0|3.16|223.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||223.9|3.16|0.0025
91772538|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0757|TWO_SIDED|95.0|0.9|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.40|0.90|0.0757
91772539|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0045|TWO_SIDED|95.0|1.71|18.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||18.74|1.71|0.0045
91772540|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0771|TWO_SIDED|95.0|0.9|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.67|0.90|0.0771
91519916|NCT02460692|182913753|SUPERIORITY|||||||0.085|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.085
91772541|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1856|TWO_SIDED|95.0|0.71|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.81|0.71|0.1856
91772542|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5973|TWO_SIDED|95.0|0.48|3.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.54|0.48|0.5973
91772543|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0935|TWO_SIDED|95.0|0.85|7.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.77|0.85|0.0935
91772544|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.52||||0.0157|TWO_SIDED|95.0|1.38|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||22.10|1.38|0.0157
91772545|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1963|TWO_SIDED|95.0|0.68|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.32|0.68|0.1963
91772546|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.31||||0.0085|TWO_SIDED|95.0|1.53|18.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||18.43|1.53|0.0085
91772547|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1433|TWO_SIDED|95.0|0.76|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.38|0.76|0.1433
91772548|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.17||||0.1577|TWO_SIDED|95.0|0.74|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.37|0.74|0.1577
91772549|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1608|TWO_SIDED|95.0|0.74|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.34|0.74|0.1608
91772550|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0693|TWO_SIDED|95.0|0.92|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.53|0.92|0.0693
91772551|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|9.57||||0.0063|TWO_SIDED|95.0|1.89|48.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||48.39|1.89|0.0063
91772552|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.25||||0.1637|TWO_SIDED|95.0|0.72|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.05|0.72|0.1637
91772553|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0326|TWO_SIDED|95.0|1.11|11.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.47|1.11|0.0326
91772554|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1455|TWO_SIDED|95.0|0.76|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.76|0.1455
91772555|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1951|TWO_SIDED|95.0|0.69|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.32|0.69|0.1951
91772556|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.56||||0.4097|TWO_SIDED|95.0|0.54|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.53|0.54|0.4097
91772557|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1554|TWO_SIDED|95.0|0.73|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.22|0.73|0.1554
91772558|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.22||||0.044|TWO_SIDED|95.0|1.04|17.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.14|1.04|0.0440
91772559|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.23||||0.1928|TWO_SIDED|95.0|0.67|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.47|0.67|0.1928
91772560|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.67||||0.0222|TWO_SIDED|95.0|1.25|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.47|1.25|0.0222
91772561|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4075|TWO_SIDED|95.0|0.54|4.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.65|0.54|0.4075
91772562|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3659|TWO_SIDED|95.0|0.56|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.56|0.3659
91772563|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7878|TWO_SIDED|95.0|0.41|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.24|0.41|0.7878
91772564|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0635|TWO_SIDED|95.0|0.94|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.38|0.94|0.0635
91772565|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|14.62||||0.0137|TWO_SIDED|95.0|1.73|123.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||123.3|1.73|0.0137
91519917|NCT02460692|182913754|SUPERIORITY|||||||0.95||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.95
91772566|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1069|TWO_SIDED|95.0|0.79|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.62|0.79|0.1069
91772567|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.6||||0.0186|TWO_SIDED|95.0|1.33|23.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||23.47|1.33|0.0186
91772568|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1434|TWO_SIDED|95.0|0.75|7.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.56|0.75|0.1434
91772569|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.2||||0.167|TWO_SIDED|95.0|0.72|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.75|0.72|0.1670
91772570|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.16||||0.781|TWO_SIDED|95.0|0.41|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.28|0.41|0.7810
91772571|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.27||||0.1682|TWO_SIDED|95.0|0.71|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.26|0.71|0.1682
91772572|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0215|TWO_SIDED|95.0|1.28|21.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.39|1.28|0.0215
91772573|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.75||||0.0306|TWO_SIDED|95.0|1.16|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.52|1.16|0.0306
91707804|NCT04227405|183308959|SUPERIORITY||Slope|1.21|STANDARD_ERROR_OF_MEAN|0.39|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping subscale||||<.01
91772574|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|10.1||||0.0059|TWO_SIDED|95.0|1.92|52.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||52.29|1.92|0.0059
91519918|NCT02460692|182913754|SUPERIORITY|||||||0.78||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.78
91772575|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1004|TWO_SIDED|95.0|0.83|8.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.43|0.83|0.1004
91772576|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1837|TWO_SIDED|95.0|0.7|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.36|0.70|0.1837
91772577|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5929|TWO_SIDED|95.0|0.47|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.75|0.47|0.5929
91772578|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2588|TWO_SIDED|95.0|0.62|6.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.07|0.62|0.2588
91772579|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|7.69||||0.0129|TWO_SIDED|95.0|1.54|38.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||38.41|1.54|0.0129
91772580|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|7.12||||0.0168|TWO_SIDED|95.0|1.42|35.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||35.61|1.42|0.0168
91772581|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|9.95||||0.0058|TWO_SIDED|95.0|1.94|50.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.97|1.94|0.0058
91772582|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1934|TWO_SIDED|95.0|0.69|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.26|0.69|0.1934
91772583|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.01||||0.2181|TWO_SIDED|95.0|0.66|6.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.12|0.66|0.2181
91519919|NCT02460692|182913754|SUPERIORITY|||||||0.99||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.99
91519920|NCT02048072|182913755|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
91772584|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4116|TWO_SIDED|95.0|0.53|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.71|0.53|0.4116
91772585|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0938|TWO_SIDED|95.0|0.84|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.66|0.84|0.0938
91772586|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|8.02||||0.0125|TWO_SIDED|95.0|1.57|41.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||41.08|1.57|0.0125
91772587|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0761|TWO_SIDED|95.0|0.88|12.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.23|0.88|0.0761
91772588|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0305|TWO_SIDED|95.0|1.14|14.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.16|1.14|0.0305
91772589|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0501|TWO_SIDED|95.0|1.0|11.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.68|1.00|0.0501
91772590|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1212|TWO_SIDED|95.0|0.78|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.77|0.78|0.1212
91772591|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8332|TWO_SIDED|95.0|0.35|3.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.68|0.35|0.8332
91772592|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.66||||0.4285|TWO_SIDED|95.0|0.48|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.48|0.4285
91772593|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0954|TWO_SIDED|95.0|0.83|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.74|0.83|0.0954
91772594|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.98||||0.111|TWO_SIDED|95.0|0.78|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.38|0.78|0.1110
91772595|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1642|TWO_SIDED|95.0|0.69|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.55|0.69|0.1642
91772596|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|2.19||||0.1976|TWO_SIDED|95.0|0.66|7.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.24|0.66|0.1976
91772597|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5761|TWO_SIDED|95.0|0.43|4.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.58|0.43|0.5761
91772598|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.64||||0.454|TWO_SIDED|95.0|0.2|2.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.04|0.20|0.4540
91772599|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3732|TWO_SIDED|95.0|0.17|1.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.96|0.17|0.3732
91772600|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4665|TWO_SIDED|95.0|0.46|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.50|0.46|0.4665
91772601|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5634|TWO_SIDED|95.0|0.41|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.25|0.41|0.5634
91772602|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.65||||0.4297|TWO_SIDED|95.0|0.48|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.70|0.48|0.4297
91772603|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9789|TWO_SIDED|95.0|0.31|3.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.14|0.31|0.9789
91772604|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7357|TWO_SIDED|95.0|0.24|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.70|0.24|0.7357
91772605|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.46||||0.1977|TWO_SIDED|95.0|0.14|1.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.50|0.14|0.1977
91772606|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3203|TWO_SIDED|95.0|0.14|1.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.88|0.14|0.3203
91772607|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9739|TWO_SIDED|95.0|0.3|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.44|0.30|0.9739
91519921|NCT01321554|182913805|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.21|||||TWO_SIDED|99.0|0.14|0.31||||||||0.31|0.14|
91772608|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6714|TWO_SIDED|95.0|0.36|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.97|0.36|0.6714
91772609|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6375|TWO_SIDED|95.0|0.22|2.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.52|0.22|0.6375
91772610|NCT03192176|183427595|SUPERIORITY||Odds Ratio (OR)|0.54||||0.298|TWO_SIDED|95.0|0.17|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.17|0.2980
91772611|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.35||||0.0044|TWO_SIDED|95.0|1.69|16.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.96|1.69|0.0044
91772612|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|8.65||||0.0002|TWO_SIDED|95.0|2.79|26.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.83|2.79|0.0002
91772613|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|10.82|||<|0.0001|TWO_SIDED|95.0|3.49|33.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.54|3.49|<0.0001
91772614|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|10.01|||<|0.0001|TWO_SIDED|95.0|3.2|31.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.29|3.20|<0.0001
91772615|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1266|TWO_SIDED|95.0|0.77|8.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.15|0.77|0.1266
91772616|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.72||||0.0024|TWO_SIDED|95.0|1.85|17.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.66|1.85|0.0024
91772617|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|7.93||||0.0003|TWO_SIDED|95.0|2.59|24.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||24.26|2.59|0.0003
91772618|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0217|TWO_SIDED|95.0|1.18|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.17|1.18|0.0217
91772619|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0021|TWO_SIDED|95.0|1.75|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.25|1.75|0.0021
91772620|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.72||||0.0016|TWO_SIDED|95.0|1.8|12.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.37|1.80|0.0016
91772621|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0018|TWO_SIDED|95.0|1.79|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.86|1.79|0.0018
91772622|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0467|TWO_SIDED|95.0|1.01|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.14|1.01|0.0467
91772623|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0016|TWO_SIDED|95.0|1.8|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.28|1.80|0.0016
91772624|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0234|TWO_SIDED|95.0|1.16|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.65|1.16|0.0234
91772625|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0294|TWO_SIDED|95.0|1.11|7.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.46|1.11|0.0294
91772626|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.74||||0.0068|TWO_SIDED|95.0|1.44|9.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.73|1.44|0.0068
91772627|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0025|TWO_SIDED|95.0|1.68|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.29|1.68|0.0025
91772628|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.82||||0.0006|TWO_SIDED|95.0|2.13|15.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.92|2.13|0.0006
91772629|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0572|TWO_SIDED|95.0|0.97|6.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.61|0.97|0.0572
91772630|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.28|15.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.97|2.28|0.0003
91772631|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.55||||0.046|TWO_SIDED|95.0|1.02|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|1.02|0.0460
91772632|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1406|TWO_SIDED|95.0|0.79|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.23|0.79|0.1406
91772633|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0234|TWO_SIDED|95.0|1.16|7.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.63|1.16|0.0234
91772634|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0302|TWO_SIDED|95.0|1.1|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.22|1.10|0.0302
91772635|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.23||||0.0016|TWO_SIDED|95.0|1.87|14.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.63|1.87|0.0016
91772636|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2105|TWO_SIDED|95.0|0.71|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.64|0.71|0.2105
91772637|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.17||||0.0033|TWO_SIDED|95.0|1.61|10.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.81|1.61|0.0033
91772638|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1087|TWO_SIDED|95.0|0.85|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.21|0.85|0.1087
91772639|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.56||||0.36|TWO_SIDED|95.0|0.6|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.03|0.60|0.3600
91772640|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1394|TWO_SIDED|95.0|0.79|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.32|0.79|0.1394
91772641|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0522|TWO_SIDED|95.0|0.99|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.36|0.99|0.0522
91772642|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0119|TWO_SIDED|95.0|1.63|11.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.61|1.63|0.0119
91772643|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1474|TWO_SIDED|95.0|0.77|5.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.53|0.77|0.1474
91772644|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.08||||0.0026|TWO_SIDED|95.0|1.76|14.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.67|1.76|0.0026
91772645|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1263|TWO_SIDED|95.0|0.81|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.51|0.81|0.1263
91772646|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2327|TWO_SIDED|95.0|0.68|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.95|0.68|0.2327
91772647|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1359|TWO_SIDED|95.0|0.79|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.70|0.79|0.1359
91772648|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0258|TWO_SIDED|95.0|1.16|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.69|1.16|0.0258
91772649|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0076|TWO_SIDED|95.0|1.51|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.04|1.51|0.0076
91772650|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1088|TWO_SIDED|95.0|0.83|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.75|0.83|0.1088
91772651|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0045|TWO_SIDED|95.0|1.64|14.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||14.62|1.64|0.0045
91772652|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0493|TWO_SIDED|95.0|1.0|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.50|1.00|0.0493
91772653|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0376|TWO_SIDED|95.0|1.06|8.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.41|1.06|0.0376
91772654|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0723|TWO_SIDED|95.0|0.92|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.94|0.92|0.0723
91772655|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0396|TWO_SIDED|95.0|1.06|9.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.17|1.06|0.0396
91772656|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0031|TWO_SIDED|95.0|1.85|20.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||20.67|1.85|0.0031
91772657|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1044|TWO_SIDED|95.0|0.83|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.96|0.83|0.1044
91772658|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0029|TWO_SIDED|95.0|1.78|16.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.75|1.78|0.0029
91772659|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0364|TWO_SIDED|95.0|1.07|8.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.45|1.07|0.0364
91772660|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6396|TWO_SIDED|95.0|0.47|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.47|0.6396
91772661|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4378|TWO_SIDED|95.0|0.55|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.55|0.4378
91772662|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.95||||0.2045|TWO_SIDED|95.0|0.7|5.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.44|0.70|0.2045
91772663|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0958|TWO_SIDED|95.0|0.85|7.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.62|0.85|0.0958
91772664|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.7||||0.321|TWO_SIDED|95.0|0.6|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.85|0.60|0.3210
91772665|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0199|TWO_SIDED|95.0|1.23|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.39|1.23|0.0199
91772666|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1219|TWO_SIDED|95.0|0.8|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.36|0.80|0.1219
91772667|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2975|TWO_SIDED|95.0|0.62|4.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.76|0.62|0.2975
91772668|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2763|TWO_SIDED|95.0|0.64|4.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.80|0.64|0.2763
91772669|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1235|TWO_SIDED|95.0|0.79|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.82|0.79|0.1235
91772670|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.24||||0.019|TWO_SIDED|95.0|1.27|14.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||14.19|1.27|0.0190
91772671|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2213|TWO_SIDED|95.0|0.66|5.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.93|0.66|0.2213
91772672|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.88||||0.005|TWO_SIDED|95.0|1.71|20.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||20.25|1.71|0.0050
91772673|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1053|TWO_SIDED|95.0|0.83|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.85|0.83|0.1053
91772674|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0991|TWO_SIDED|95.0|0.85|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.72|0.85|0.0991
91772675|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2056|TWO_SIDED|95.0|0.7|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.32|0.70|0.2056
91772676|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0407|TWO_SIDED|95.0|1.05|9.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.57|1.05|0.0407
91772677|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0059|TWO_SIDED|95.0|1.63|18.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.30|1.63|0.0059
91772678|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.85||||0.023|TWO_SIDED|95.0|1.2|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.30|1.20|0.0230
91519924|NCT00772590|182913839|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||||||<0.01
91772679|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0015|TWO_SIDED|95.0|2.14|25.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.29|2.14|0.0015
91772680|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0248|TWO_SIDED|95.0|1.17|10.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.16|1.17|0.0248
91772681|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1091|TWO_SIDED|95.0|0.82|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.83|0.82|0.1091
91772682|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3054|TWO_SIDED|95.0|0.61|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.75|0.61|0.3054
91772683|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1129|TWO_SIDED|95.0|0.81|7.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.61|0.81|0.1129
91772684|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0432|TWO_SIDED|95.0|1.04|10.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.37|1.04|0.0432
91772685|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0315|TWO_SIDED|95.0|1.13|12.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.60|1.13|0.0315
91772686|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0147|TWO_SIDED|95.0|1.33|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.64|1.33|0.0147
91772687|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0405|TWO_SIDED|95.0|1.05|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.59|1.05|0.0405
91772688|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5238|TWO_SIDED|95.0|0.5|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.93|0.50|0.5238
91772689|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.73||||0.306|TWO_SIDED|95.0|0.6|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.97|0.60|0.3060
91772690|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3747|TWO_SIDED|95.0|0.55|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.86|0.55|0.3747
91772691|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0443|TWO_SIDED|95.0|1.03|11.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.80|1.03|0.0443
91519925|NCT03813238|182913854|SUPERIORITY||LS mean difference|-1.2||||0.335|TWO_SIDED|95.0|-3.49|1.19|||Mixed Models Analysis|||The LS mean of the change in MDCRS part II total score from baseline to Week 15 was compared (TEV-50717 arm versus placebo) using a 1-sided test for superiority at a nominal significance level of α=0.025.||1.19|-3.49|0.335
91519926|NCT02066402|182913883|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance. Predefined margin for non-inferiority is -10%.|Difference of responder rate|-4.6||||0.2027|TWO_SIDED|95.0|-11.2|2.2|||Fisher Exact|||||2.2|-11.2|0.2027
91772692|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1269|TWO_SIDED|95.0|0.77|8.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.06|0.77|0.1269
91519927|NCT02066402|182913884|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.3|3.8||||||||3.8|-8.3|
91519928|NCT02066402|182913885|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.1|||||TWO_SIDED|95.0|-7.4|3.2||||||||3.2|-7.4|
91519929|NCT02066402|182913886|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.6|4.1||||||||4.1|-8.6|
91519930|NCT02066402|182913887|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-3.1|||||TWO_SIDED|95.0|-8.4|2.0||||||||2.0|-8.4|
91772693|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|5.15||||0.0095|TWO_SIDED|95.0|1.49|17.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.13|1.49|0.0095
91519931|NCT03581981|182913942|SUPERIORITY|see statistical plan|Mean Difference (Final Values)|-3.6||||0.33|TWO_SIDED|95.0|-10.7|3.6|||Mixed Models Analysis|||||3.6|-10.7|0.33
91772694|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1254|TWO_SIDED|95.0|0.79|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.79|0.1254
91772695|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0402|TWO_SIDED|95.0|1.06|12.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.63|1.06|0.0402
91772696|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4547|TWO_SIDED|95.0|0.47|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.47|0.4547
91772697|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4008|TWO_SIDED|95.0|0.49|5.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.99|0.49|0.4008
91772698|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1535|TWO_SIDED|95.0|0.71|9.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.22|0.71|0.1535
91772699|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0055|TWO_SIDED|95.0|1.79|28.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||28.95|1.79|0.0055
91772700|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2116|TWO_SIDED|95.0|0.64|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.50|0.64|0.2116
91772701|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1668|TWO_SIDED|95.0|0.7|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.83|0.70|0.1668
91772702|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1824|TWO_SIDED|95.0|0.67|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.98|0.67|0.1824
91772703|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|0.85||||0.797|TWO_SIDED|95.0|0.25|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.90|0.25|0.7970
91772704|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|0.78||||0.7065|TWO_SIDED|95.0|0.21|2.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.85|0.21|0.7065
91772705|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9126|TWO_SIDED|95.0|0.29|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.93|0.29|0.9126
91772706|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1282|TWO_SIDED|95.0|0.74|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.70|0.74|0.1282
91772707|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2661|TWO_SIDED|95.0|0.58|7.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.04|0.58|0.2661
91772708|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7457|TWO_SIDED|95.0|0.36|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.09|0.36|0.7457
91772709|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.73||||0.4095|TWO_SIDED|95.0|0.47|6.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.41|0.47|0.4095
91772710|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9571|TWO_SIDED|95.0|0.28|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.77|0.28|0.9571
91519932|NCT03581981|182913943|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
91519933|NCT03581981|182913944|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
91519934|NCT03581981|182913945|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.99|TWO_SIDED|95.0|-3.6|3.6|||Mixed Models Analysis|||||3.6|-3.6|0.99
91772711|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8827|TWO_SIDED|95.0|0.23|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.59|0.23|0.8827
91772712|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5944|TWO_SIDED|95.0|0.17|2.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.74|0.17|0.5944
91772713|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1647|TWO_SIDED|95.0|0.66|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.39|0.66|0.1647
91772714|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|2.07||||0.2684|TWO_SIDED|95.0|0.57|7.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.48|0.57|0.2684
91772715|NCT03192176|183427596|SUPERIORITY||Odds Ratio (OR)|1.48||||0.5338|TWO_SIDED|95.0|0.43|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.07|0.43|0.5338
91772716|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.45||0.0179|TWO_SIDED|95.0|-1.95|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|Mixed model repeated measures (MMRM)|||Week 4||-0.18|-1.95|0.0179
91772717|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.25|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.47|-2.25|0.0027
91772718|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45||0.0004|TWO_SIDED|95.0|-2.5|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.73|-2.50|0.0004
91519935|NCT03581981|182913946|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.52|TWO_SIDED|95.0|-7.3|3.7|||Mixed Models Analysis|||||3.7|-7.3|0.52
91772719|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.46||0.0009|TWO_SIDED|95.0|-2.43|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.64|-2.43|0.0009
91772720|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5806|TWO_SIDED|95.0|-1.14|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||0.64|-1.14|0.5806
91772721|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.45||0.0105|TWO_SIDED|95.0|-2.03|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.27|-2.03|0.0105
91772722|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0048|TWO_SIDED|95.0|-2.16|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.39|-2.16|0.0048
91772723|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1801|TWO_SIDED|95.0|-1.52|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.29|-1.52|0.1801
91772724|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0609|TWO_SIDED|95.0|-1.76|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.04|-1.76|0.0609
91772725|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.47||0.0028|TWO_SIDED|95.0|-2.33|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.49|-2.33|0.0028
91772726|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.47||0.0018|TWO_SIDED|95.0|-2.4|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-2.40|0.0018
91772727|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5519|TWO_SIDED|95.0|-1.19|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.64|-1.19|0.5519
91519936|NCT03581981|182913947|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.4|2.9|||Mixed Models Analysis|||||2.9|-1.4|0.50
91519937|NCT03581981|182913948|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
91519938|NCT03581981|182913949|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
91519939|NCT03581981|182913950|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
91519940|NCT03581981|182913951|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
91519941|NCT03581981|182913952|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
91772728|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1922|TWO_SIDED|95.0|-1.51|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.31|-1.51|0.1922
91772729|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0463|TWO_SIDED|95.0|-1.82|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.02|-1.82|0.0463
91772730|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.1288|TWO_SIDED|95.0|-1.53|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.19|-1.53|0.1288
91772731|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0577|TWO_SIDED|95.0|-1.72|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.03|-1.72|0.0577
91772732|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.26|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.48|-2.26|0.0027
91772733|NCT03192176|183427597|SUPERIORITY||-1.3|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0043|TWO_SIDED|95.0|-2.2|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.41|-2.20|0.0043
91772734|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.4089|TWO_SIDED|95.0|-1.27|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.52|-1.27|0.4089
91519942|NCT03581981|182913953|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
91772735|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44||0.205|TWO_SIDED|95.0|-1.44|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.31|-1.44|0.2050
91772736|NCT03192176|183427597|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0265|TWO_SIDED|95.0|-1.84|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.11|-1.84|0.0265
91772737|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.7617|TWO_SIDED|95.0|-1.2|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.88|-1.20|0.7617
91772738|NCT03192176|183427597|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6061|TWO_SIDED|95.0|-0.77|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.32|-0.77|0.6061
91772739|NCT03192176|183427597|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.7997|TWO_SIDED|95.0|-0.93|1.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.21|-0.93|0.7997
91772740|NCT03192176|183427597|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3391|TWO_SIDED|95.0|-0.55|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.60|-0.55|0.3391
91772741|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3934|TWO_SIDED|95.0|-1.55|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.61|-1.55|0.3934
91772742|NCT03192176|183427597|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.975|TWO_SIDED|95.0|-1.08|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.04|-1.08|0.9750
91772743|NCT03192176|183427597|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.883|TWO_SIDED|95.0|-1.13|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.97|-1.13|0.8830
91519943|NCT00863655|182913960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Log Rank|||||0.54|0.35|<0.0001
91772744|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.27||0.5872|TWO_SIDED|95.0|-6.09|10.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.73|-6.09|0.5872
91772745|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.8|STANDARD_ERROR_OF_MEAN|4.33||0.3779|TWO_SIDED|95.0|-4.7|12.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.35|-4.70|0.3779
91772746|NCT03192176|183427598|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|4.34||0.3506|TWO_SIDED|95.0|-12.61|4.49||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||4.49|-12.61|0.3506
91772747|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.0|STANDARD_ERROR_OF_MEAN|4.39||0.8236|TWO_SIDED|95.0|-7.66|9.62||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||9.62|-7.66|0.8236
91772748|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.35||0.5949|TWO_SIDED|95.0|-6.24|10.87||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.87|-6.24|0.5949
91772749|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.19||0.9237|TWO_SIDED|95.0|-8.65|7.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||7.85|-8.65|0.9237
91772750|NCT03192176|183427598|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.32||0.3599|TWO_SIDED|95.0|-4.54|12.46||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.46|-4.54|0.3599
91772751|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|5.08||0.7422|TWO_SIDED|95.0|-8.33|11.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||11.68|-8.33|0.7422
91772752|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|5.09||0.603|TWO_SIDED|95.0|-12.67|7.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||7.37|-12.67|0.6030
91772753|NCT03192176|183427598|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|5.14||0.2478|TWO_SIDED|95.0|-16.07|4.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||4.17|-16.07|0.2478
91772754|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|5.18||0.5295|TWO_SIDED|95.0|-6.94|13.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.47|-6.94|0.5295
91772755|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|5.16||0.6938|TWO_SIDED|95.0|-12.2|8.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||8.13|-12.20|0.6938
91772756|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.97||0.9765|TWO_SIDED|95.0|-9.93|9.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||9.63|-9.93|0.9765
91772757|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.7|STANDARD_ERROR_OF_MEAN|5.13||0.4771|TWO_SIDED|95.0|-6.45|13.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.76|-6.45|0.4771
91772758|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|4.44||0.4256|TWO_SIDED|95.0|-5.19|12.27||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||12.27|-5.19|0.4256
91772759|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|4.45||0.9559|TWO_SIDED|95.0|-8.52|9.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||9.01|-8.52|0.9559
91772760|NCT03192176|183427598|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|4.49||0.2003|TWO_SIDED|95.0|-14.6|3.07||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||3.07|-14.60|0.2003
91519944|NCT00716092|182913987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001||95.0|-28.0|-11.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-11.9|-28.0|<0.0001
91772761|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|4.53||0.6692|TWO_SIDED|95.0|-10.86|6.98||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||6.98|-10.86|0.6692
91772762|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.51||0.6894|TWO_SIDED|95.0|-10.68|7.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||7.08|-10.68|0.6894
91772763|NCT03192176|183427598|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|4.35||0.1627|TWO_SIDED|95.0|-14.66|2.48||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||2.48|-14.66|0.1627
91772764|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.48||0.9371|TWO_SIDED|95.0|-9.18|8.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||8.47|-9.18|0.9371
91772765|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|4.53||0.8521|TWO_SIDED|95.0|-8.07|9.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.77|-8.07|0.8521
91772766|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.56||0.9367|TWO_SIDED|95.0|-8.62|9.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.35|-8.62|0.9367
91772767|NCT03192176|183427598|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|4.57||0.0551|TWO_SIDED|95.0|-17.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||0.19|-17.82|0.0551
91772768|NCT03192176|183427598|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|4.64||0.4936|TWO_SIDED|95.0|-12.32|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||5.96|-12.32|0.4936
91772769|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|4.59||0.6404|TWO_SIDED|95.0|-6.89|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||11.17|-6.89|0.6404
91772770|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.45||0.8955|TWO_SIDED|95.0|-8.17|9.34||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.34|-8.17|0.8955
91772771|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|4.59||0.9776|TWO_SIDED|95.0|-8.91|9.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.17|-8.91|0.9776
91772772|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|4.14||0.7852|TWO_SIDED|95.0|-9.27|7.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||7.01|-9.27|0.7852
91772773|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|4.15||0.7812|TWO_SIDED|95.0|-7.02|9.33||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.33|-7.02|0.7812
91772774|NCT03192176|183427598|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|4.23||0.2648|TWO_SIDED|95.0|-13.07|3.61||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||3.61|-13.07|0.2648
91772775|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|4.25||0.6312|TWO_SIDED|95.0|-10.41|6.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||6.32|-10.41|0.6312
91772776|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.4|STANDARD_ERROR_OF_MEAN|4.2||0.7416|TWO_SIDED|95.0|-6.89|9.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.67|-6.89|0.7416
91772777|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|4.12||0.4254|TWO_SIDED|95.0|-4.83|11.41||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.41|-4.83|0.4254
91772778|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.4|STANDARD_ERROR_OF_MEAN|4.11||0.4038|TWO_SIDED|95.0|-4.66|11.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.54|-4.66|0.4038
91772779|NCT03192176|183427598|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|4.91||0.327|TWO_SIDED|95.0|-14.49|4.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||4.85|-14.49|0.3270
91772780|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.85||0.7333|TWO_SIDED|95.0|-11.21|7.9||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.90|-11.21|0.7333
91772781|NCT03192176|183427598|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|4.99||0.1319|TWO_SIDED|95.0|-17.36|2.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||2.28|-17.36|0.1319
91772782|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|5.0||0.6132|TWO_SIDED|95.0|-12.38|7.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.32|-12.38|0.6132
91646084|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.3132|TWO_SIDED|95.0|0.92|1.29|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.29|0.92|0.3132
91772783|NCT03192176|183427598|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|4.98||0.4024|TWO_SIDED|95.0|-13.98|5.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||5.63|-13.98|0.4024
91772784|NCT03192176|183427598|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|4.88||0.4904|TWO_SIDED|95.0|-12.97|6.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.23|-12.97|0.4904
91772785|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|4.87||0.5521|TWO_SIDED|95.0|-12.48|6.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.69|-12.48|0.5521
91772786|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.5||0.737|TWO_SIDED|95.0|-10.38|7.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||7.35|-10.38|0.7370
91772787|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|4.46||0.5269|TWO_SIDED|95.0|-11.62|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.96|-11.62|0.5269
91772788|NCT03192176|183427598|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|4.58||0.3937|TWO_SIDED|95.0|-12.93|5.11||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.11|-12.93|0.3937
91772789|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.59||0.846|TWO_SIDED|95.0|-8.15|9.94||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.94|-8.15|0.8460
91772790|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|4.57||0.5673|TWO_SIDED|95.0|-11.62|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||6.38|-11.62|0.5673
91772791|NCT03192176|183427598|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.49||0.3791|TWO_SIDED|95.0|-4.88|12.79||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||12.79|-4.88|0.3791
91772792|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.47||0.834|TWO_SIDED|95.0|-7.86|9.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.73|-7.86|0.8340
91772793|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|4.67||0.9457|TWO_SIDED|95.0|-9.51|8.88||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.88|-9.51|0.9457
91772794|NCT03192176|183427598|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|4.65||0.657|TWO_SIDED|95.0|-11.22|7.09||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||7.09|-11.22|0.6570
91772795|NCT03192176|183427598|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.73||0.231|TWO_SIDED|95.0|-15.0|3.64||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||3.64|-15.00|0.2310
91772796|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.77||0.9066|TWO_SIDED|95.0|-8.84|9.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.96|-8.84|0.9066
91772797|NCT03192176|183427598|SUPERIORITY||LSMean differnce|-5.0|STANDARD_ERROR_OF_MEAN|4.71||0.2914|TWO_SIDED|95.0|-14.26|4.3||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||4.30|-14.26|0.2914
91772798|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9277|TWO_SIDED|95.0|-8.73|9.57||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.57|-8.73|0.9277
91772799|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9367|TWO_SIDED|95.0|-9.51|8.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.77|-9.51|0.9367
91772800|NCT03192176|183427598|SUPERIORITY||LSMean difference|5.1|STANDARD_ERROR_OF_MEAN|4.35||0.2407|TWO_SIDED|95.0|-3.46|13.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||13.69|-3.46|0.2407
91772801|NCT03192176|183427598|SUPERIORITY||LSMean difference|6.9|STANDARD_ERROR_OF_MEAN|4.55||0.1305|TWO_SIDED|95.0|-2.06|15.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.89|-2.06|0.1305
91772802|NCT03192176|183427598|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|4.59||0.2152|TWO_SIDED|95.0|-3.34|14.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||14.75|-3.34|0.2152
91772803|NCT03192176|183427598|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|4.72||0.1099|TWO_SIDED|95.0|-1.73|16.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.89|-1.73|0.1099
91646085|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0762|TWO_SIDED|95.0|0.99|1.26|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.26|0.99|0.0762
91772804|NCT03192176|183427598|SUPERIORITY||LSMean difference|7.4|STANDARD_ERROR_OF_MEAN|4.75||0.1219|TWO_SIDED|95.0|-1.99|16.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.75|-1.99|0.1219
91519945|NCT00716092|182913988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001||95.0|12.4|23.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||23.9|12.4|<0.0001
91519946|NCT00716092|182913989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.8||0.0283||95.0|-20.4|-1.2|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-1.2|-20.4|0.0283
91772805|NCT03192176|183427598|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|4.44||0.0316|TWO_SIDED|95.0|0.85|18.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||18.36|0.85|0.0316
91772806|NCT03192176|183427598|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|4.47||0.1557|TWO_SIDED|95.0|-2.44|15.16||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.16|-2.44|0.1557
91772807|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.97||0.8592|TWO_SIDED|95.0|-8.91|10.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.67|-8.91|0.8592
91772808|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|5.15||0.6891|TWO_SIDED|95.0|-8.08|12.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||12.20|-8.08|0.6891
91772809|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.2||0.9481|TWO_SIDED|95.0|-10.59|9.92||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||9.92|-10.59|0.9481
91772810|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|5.36||0.7246|TWO_SIDED|95.0|-12.46|8.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||8.68|-12.46|0.7246
91772811|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|5.45||0.8842|TWO_SIDED|95.0|-9.94|11.53||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.53|-9.94|0.8842
91772812|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|5.05||0.8103|TWO_SIDED|95.0|-8.74|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.17|-8.74|0.8103
91772813|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.1||0.9631|TWO_SIDED|95.0|-9.81|10.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.28|-9.81|0.9631
91772814|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.87||0.9788|TWO_SIDED|95.0|-9.73|9.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||9.47|-9.73|0.9788
91772815|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|5.02||0.7875|TWO_SIDED|95.0|-11.26|8.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||8.54|-11.26|0.7875
91772816|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.08||0.9746|TWO_SIDED|95.0|-9.85|10.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.17|-9.85|0.9746
91772817|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|5.21||0.9092|TWO_SIDED|95.0|-9.67|10.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.86|-9.67|0.9092
91519947|NCT00716092|182913990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.5|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001||95.0|-147.0|-66.0|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-66.0|-147.0|<0.0001
91772818|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|5.27||0.9745|TWO_SIDED|95.0|-10.55|10.21||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.21|-10.55|0.9745
91772819|NCT03192176|183427598|SUPERIORITY||LSMean difference|4.7|STANDARD_ERROR_OF_MEAN|4.95||0.3458|TWO_SIDED|95.0|-5.08|14.44||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||14.44|-5.08|0.3458
91772820|NCT03192176|183427598|SUPERIORITY||LSMean differnce|3.6|STANDARD_ERROR_OF_MEAN|4.98||0.4657|TWO_SIDED|95.0|-6.17|13.45||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||13.45|-6.17|0.4657
91772821|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.8|STANDARD_ERROR_OF_MEAN|5.07||0.5838|TWO_SIDED|95.0|-7.2|12.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.76|-7.20|0.5838
91772822|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.1|STANDARD_ERROR_OF_MEAN|5.22||0.8322|TWO_SIDED|95.0|-9.18|11.39||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||11.39|-9.18|0.8322
91772823|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.8|STANDARD_ERROR_OF_MEAN|5.26||0.7366|TWO_SIDED|95.0|-8.59|12.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.13|-8.59|0.7366
91772824|NCT03192176|183427598|SUPERIORITY||LSMean difference|5.6|STANDARD_ERROR_OF_MEAN|5.4||0.2971|TWO_SIDED|95.0|-4.99|16.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||16.28|-4.99|0.2971
91772825|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.41||0.9562|TWO_SIDED|95.0|-10.96|10.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||10.37|-10.96|0.9562
91772826|NCT03192176|183427598|SUPERIORITY||0.28|8.7|STANDARD_ERROR_OF_MEAN|5.13||0.0926|TWO_SIDED|95.0|-1.44|18.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||18.76|-1.44|0.0926
91772827|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|5.18||0.4996|TWO_SIDED|95.0|-6.7|13.7||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||13.70|-6.70|0.4996
91772828|NCT03192176|183427598|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|4.76||0.896|TWO_SIDED|95.0|-9.99|8.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.75|-9.99|0.8960
91772829|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|4.89||0.5471|TWO_SIDED|95.0|-6.68|12.58||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||12.58|-6.68|0.5471
91772830|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|4.93||0.738|TWO_SIDED|95.0|-8.06|11.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||11.36|-8.06|0.7380
91772831|NCT03192176|183427598|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|5.14||0.0644|TWO_SIDED|95.0|-0.58|19.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||19.69|-0.58|0.0644
91772832|NCT03192176|183427598|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|5.04||0.8475|TWO_SIDED|95.0|-10.9|8.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.96|-10.90|0.8475
91772833|NCT03192176|183427598|SUPERIORITY||LSMean difference|5.0|STANDARD_ERROR_OF_MEAN|4.86||0.3044|TWO_SIDED|95.0|-4.57|14.59||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||14.59|-4.57|0.3044
91772834|NCT03192176|183427598|SUPERIORITY||LSMean difference|4.2|STANDARD_ERROR_OF_MEAN|4.89||0.3895|TWO_SIDED|95.0|-5.42|13.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||13.86|-5.42|0.3895
91772835|NCT03192176|183427598|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|6.07||0.4551|TWO_SIDED|95.0|-16.5|7.42||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||7.42|-16.50|0.4551
91772836|NCT03192176|183427598|SUPERIORITY||LSMean differencce|-2.2|STANDARD_ERROR_OF_MEAN|6.1||0.7182|TWO_SIDED|95.0|-14.21|9.81||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.81|-14.21|0.7182
91772837|NCT03192176|183427598|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|6.21||0.6259|TWO_SIDED|95.0|-15.26|9.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.20|-15.26|0.6259
91772838|NCT03192176|183427598|SUPERIORITY||LSMean difference|6.6|STANDARD_ERROR_OF_MEAN|6.5||0.312|TWO_SIDED|95.0|-6.22|19.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||19.40|-6.22|0.3120
91772839|NCT03192176|183427598|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|6.41||0.3297|TWO_SIDED|95.0|-18.89|6.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||6.37|-18.89|0.3297
91772840|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|6.16||0.613|TWO_SIDED|95.0|-9.02|15.26||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||15.26|-9.02|0.6130
91772841|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|6.22||0.7292|TWO_SIDED|95.0|-10.09|14.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||14.40|-10.09|0.7292
91772842|NCT03192176|183427598|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|5.6||0.8695|TWO_SIDED|95.0|-1.11|11.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||11.96|-1.11|0.8695
91772843|NCT03192176|183427598|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|5.64||0.58|TWO_SIDED|95.0|-7.99|14.25||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||14.25|-7.99|0.5800
91772844|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|5.74||0.7024|TWO_SIDED|95.0|-9.11|13.5||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.50|-9.11|0.7024
91772845|NCT03192176|183427598|SUPERIORITY||LSMean difference|11.4|STANDARD_ERROR_OF_MEAN|5.99||0.0572|TWO_SIDED|95.0|-0.35|23.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||23.23|-0.35|0.0572
91772846|NCT03192176|183427598|SUPERIORITY||LSMean difference|1.6|STANDARD_ERROR_OF_MEAN|5.93||0.783|TWO_SIDED|95.0|-10.04|13.31||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.31|-10.04|0.7830
91772847|NCT03192176|183427598|SUPERIORITY||0.1|15.4|STANDARD_ERROR_OF_MEAN|5.71||0.0074|TWO_SIDED|95.0|4.19|26.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||26.67|4.19|0.0074
91772848|NCT03192176|183427598|SUPERIORITY||LSMean difference|11.0|STANDARD_ERROR_OF_MEAN|5.73||0.0551|TWO_SIDED|95.0|-0.24|22.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||22.32|-0.24|0.0551
91772849|NCT03192176|183427598|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.51||0.2959|TWO_SIDED|95.0|-16.63|5.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||5.08|-16.63|0.2959
91772850|NCT03192176|183427598|SUPERIORITY||LSMean difference|5.8|STANDARD_ERROR_OF_MEAN|5.55||0.2976|TWO_SIDED|95.0|-5.14|16.74||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||16.74|-5.14|0.2976
91772851|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.0|STANDARD_ERROR_OF_MEAN|5.62||0.7236|TWO_SIDED|95.0|-9.07|13.05||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.05|-9.07|0.7236
91772852|NCT03192176|183427598|SUPERIORITY||LSMean difference|10.1|STANDARD_ERROR_OF_MEAN|5.88||0.0884|TWO_SIDED|95.0|-1.52|21.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||21.63|-1.52|0.0884
91772853|NCT03192176|183427598|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|5.77||0.3887|TWO_SIDED|95.0|-16.35|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||6.38|-16.35|0.3887
91772854|NCT03192176|183427598|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|5.59||0.2671|TWO_SIDED|95.0|-4.8|17.24||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||17.24|-4.80|0.2671
91772855|NCT03192176|183427598|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|5.63||0.6076|TWO_SIDED|95.0|-8.2|13.99||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.99|-8.20|0.6076
91772856|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.91||0.2159|TWO_SIDED|95.0|-2.93|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.67|-2.93|0.2159
91772857|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0405|TWO_SIDED|95.0|-3.7|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.08|-3.70|0.0405
91772858|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.93||0.0115|TWO_SIDED|95.0|-4.18|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.53|-4.18|0.0115
91772859|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.93||0.0553|TWO_SIDED|95.0|-3.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.04|-3.62|0.0553
91772860|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.92||0.2753|TWO_SIDED|95.0|-2.82|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.80|-2.82|0.2753
91772861|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.514|TWO_SIDED|95.0|-1.2|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||2.40|-1.20|0.5140
91772862|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.93||0.0178|TWO_SIDED|95.0|-4.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.38|-4.03|0.0178
91772863|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9675|TWO_SIDED|95.0|-1.02|0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.98|-1.02|0.9675
91646086|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.7243|TWO_SIDED|95.0|0.91|1.15|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.91|0.7243
91772864|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3122|TWO_SIDED|95.0|-1.52|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.49|-1.52|0.3122
91772865|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9977|TWO_SIDED|95.0|-1.0|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.00|-1.00|0.9977
91772866|NCT03192176|183427599|SUPERIORITY||LSMean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9312|TWO_SIDED|95.0|-1.05|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.97|-1.05|0.9312
91772867|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.6005|TWO_SIDED|95.0|-1.27|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.74|-1.27|0.6005
91772868|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.5284|TWO_SIDED|95.0|-0.68|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.32|-0.68|0.5284
91772869|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.1111|TWO_SIDED|95.0|-1.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.19|-1.82|0.1111
91772870|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1764|TWO_SIDED|95.0|-1.16|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.21|-1.16|0.1764
91772871|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0037|TWO_SIDED|95.0|-1.73|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms||-0.34|-1.73|0.0037
91772872|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.3|-0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.92|-2.30|<0.0001
91772873|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.21|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.81|-2.21|<0.0001
91772874|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1444|TWO_SIDED|95.0|-1.21|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.18|-1.21|0.1444
91772875|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.35||0.0088|TWO_SIDED|95.0|-1.6|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.23|-1.60|0.0088
91772876|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.35||0.0005|TWO_SIDED|95.0|-1.93|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.54|-1.93|0.0005
91772877|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0416|TWO_SIDED|95.0|-0.69|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.01|-0.69|0.0416
91772878|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0353|TWO_SIDED|95.0|-0.71|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.03|-0.71|0.0353
91772879|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.84|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.16|-0.84|0.0040
91646087|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0775|TWO_SIDED|95.0|0.97|1.65|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||1.65|0.97|0.0775
91772880|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0495|TWO_SIDED|95.0|-0.69|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.00|-0.69|0.0495
91772881|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8665|TWO_SIDED|95.0|-0.31|0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.37|-0.31|0.8665
91772882|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9303|TWO_SIDED|95.0|-0.35|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.32|-0.35|0.9303
91772883|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.1039|TWO_SIDED|95.0|-0.62|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.06|-0.62|0.1039
91772884|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.54||0.2547|TWO_SIDED|95.0|-4.78|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.27|-4.78|0.2547
91772885|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|1.55||0.0225|TWO_SIDED|95.0|-6.6|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.50|-6.60|0.0225
91772886|NCT03192176|183427599|SUPERIORITY||LSMean differencce|-4.3|STANDARD_ERROR_OF_MEAN|1.55||0.0058|TWO_SIDED|95.0|-7.38|-1.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.26|-7.38|0.0058
91772887|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.56||0.0301|TWO_SIDED|95.0|-6.48|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.33|-6.48|0.0301
91772888|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.55||0.322|TWO_SIDED|95.0|-4.59|1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.51|-4.59|0.3220
91772889|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.54||0.8782|TWO_SIDED|95.0|-2.8|3.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||3.27|-2.80|0.8782
91772890|NCT03192176|183427599|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.0069|TWO_SIDED|95.0|-7.27|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.17|-7.27|0.0069
91772891|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.95||0.089|TWO_SIDED|95.0|-3.49|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.25|-3.49|0.0890
91772892|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.95||0.1444|TWO_SIDED|95.0|-3.25|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.48|-3.25|0.1444
91772893|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.1022|TWO_SIDED|95.0|-3.51|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.32|-3.51|0.1022
91772894|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.97||0.2342|TWO_SIDED|95.0|-3.07|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.75|-3.07|0.2342
91772895|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.96||0.9906|TWO_SIDED|95.0|-1.89|1.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||1.87|-1.89|0.9906
91772896|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.577|TWO_SIDED|95.0|-1.34|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||2.40|-1.34|0.5770
91772897|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.95||0.1865|TWO_SIDED|95.0|-3.14|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.61|-3.14|0.1865
91772898|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4575|TWO_SIDED|95.0|-1.45|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.65|-1.45|0.4575
91772899|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6016|TWO_SIDED|95.0|-1.33|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.77|-1.33|0.6016
91772900|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7026|TWO_SIDED|95.0|-0.86|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.28|-0.86|0.7026
91772901|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.2971|TWO_SIDED|95.0|-1.64|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.50|-1.64|0.2971
91772902|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.54||0.5491|TWO_SIDED|95.0|-1.38|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.74|-1.38|0.5491
91772903|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7142|TWO_SIDED|95.0|-0.86|1.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.25|-0.86|0.7142
91772904|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1157|TWO_SIDED|95.0|-1.89|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.21|-1.89|0.1157
91772905|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.36||0.1114|TWO_SIDED|95.0|-1.3|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||0.14|-1.30|0.1114
91772906|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.36||0.0025|TWO_SIDED|95.0|-1.83|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.40|-1.83|0.0025
91772907|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.2|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Scre||-0.74|-2.20|<0.0001
91772908|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.37||0.5093|TWO_SIDED|95.0|-0.96|0.48|||MMRM|||Week 8: Vasomotor Symptoms Score||0.48|-0.96|0.5093
91772909|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.33|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.86|-2.33|<0.0001
91772910|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.36||0.009|TWO_SIDED|95.0|-1.67|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.24|-1.67|0.0090
91772911|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0024|TWO_SIDED|95.0|-1.84|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 4: Vasomotor Symptoms Score||-0.40|-1.84|0.0024
91772912|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5497|TWO_SIDED|95.0|-0.47|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.25|-0.47|0.5497
91646088|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2649|TWO_SIDED|95.0|0.89|1.52|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.52|0.89|0.2649
91772913|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0276|TWO_SIDED|95.0|-0.76|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.76|0.0276
91772914|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1274|TWO_SIDED|95.0|-0.65|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.08|-0.65|0.1274
91772915|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.1865|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1865
91772916|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1857|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1857
91772917|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.8631|TWO_SIDED|95.0|-0.33|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.39|-0.33|0.8631
91772918|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0304|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.75|0.0304
91772919|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.63||0.1246|TWO_SIDED|95.0|-5.71|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.70|-5.71|0.1246
91772920|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.63||0.068|TWO_SIDED|95.0|-6.19|0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.22|-6.19|0.0680
91772921|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.67||0.0729|TWO_SIDED|95.0|-6.28|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.28|-6.28|0.0729
91772922|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|1.66||0.0541|TWO_SIDED|95.0|-6.49|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.06|-6.49|0.0541
91772923|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|95.0|-3.87|2.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||2.59|-3.87|0.6960
91772924|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.63||0.9725|TWO_SIDED|95.0|-3.27|3.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||3.15|-3.27|0.9725
91772925|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.63||0.0419|TWO_SIDED|95.0|-6.53|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||-0.12|-6.53|0.0419
91772926|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0794|TWO_SIDED|95.0|-3.57|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.20|-3.57|0.0794
91772927|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.1153|TWO_SIDED|95.0|-3.47|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.38|-3.47|0.1153
91772928|NCT03192176|183427599|SUPERIORITY||-1.5|-1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1334|TWO_SIDED|95.0|-3.47|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.46|-3.47|0.1334
91772929|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.3457|TWO_SIDED|95.0|-2.93|1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.03|-2.93|0.3457
91772930|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2607|TWO_SIDED|95.0|-3.07|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.83|-3.07|0.2607
91772931|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.7816|TWO_SIDED|95.0|-2.18|1.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.64|-2.18|0.7816
91772932|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.0955|TWO_SIDED|95.0|-3.54|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.29|-3.54|0.0955
91772933|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.2582|TWO_SIDED|95.0|-1.57|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.42|-1.57|0.2582
91772934|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.52||0.3448|TWO_SIDED|95.0|-0.53|1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.52|-0.53|0.3448
91772935|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.6587|TWO_SIDED|95.0|-0.81|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.28|-0.81|0.6587
91772936|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8299|TWO_SIDED|95.0|-1.16|0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.93|-1.16|0.8299
91772937|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8129|TWO_SIDED|95.0|-1.17|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.92|-1.17|0.8129
91772938|NCT03192176|183427599|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.52||0.213|TWO_SIDED|95.0|-0.37|1.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.66|-0.37|0.2130
91772939|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4131|TWO_SIDED|95.0|-1.42|0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.59|-1.42|0.4131
91772940|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.1273|TWO_SIDED|95.0|-1.2|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||0.15|-1.20|0.1273
91772941|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0046|TWO_SIDED|95.0|-1.69|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.31|-1.69|0.0046
91772942|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.19|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.80|-2.19|<0.0001
91772943|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.19|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.78|-2.19|<0.0001
91772944|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0333|TWO_SIDED|95.0|-1.45|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.06|-1.45|0.0333
91772945|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0423|TWO_SIDED|95.0|-1.39|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.02|-1.39|0.0423
91772946|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0208|TWO_SIDED|95.0|-1.49|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.12|-1.49|0.0208
91772947|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3435|TWO_SIDED|95.0|-0.55|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.19|-0.55|0.3435
91772948|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.98|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.22|-0.98|0.0021
91772949|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0408|TWO_SIDED|95.0|-0.79|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.02|-0.79|0.0408
91772950|NCT03192176|183427599|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0911|TWO_SIDED|95.0|-0.73|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.05|-0.73|0.0911
91772951|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7891|TWO_SIDED|95.0|-0.44|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.33|-0.44|0.7891
91772952|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9973|TWO_SIDED|95.0|-0.38|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.38|-0.38|0.9973
91772953|NCT03192176|183427599|SUPERIORITY||-0.1|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6377|TWO_SIDED|95.0|-0.47|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.29|-0.47|0.6377
91772954|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.61||0.0862|TWO_SIDED|95.0|-5.95|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.40|-5.95|0.0862
91772955|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.65||0.1305|TWO_SIDED|95.0|-5.74|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.74|-5.74|0.1305
91772956|NCT03192176|183427599|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.68||0.0707|TWO_SIDED|95.0|-6.34|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.26|-6.34|0.0707
91772957|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.68||0.1232|TWO_SIDED|95.0|-5.92|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.71|-5.92|0.1232
91772958|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.66||0.253|TWO_SIDED|95.0|-5.18|1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||1.37|-5.18|0.2530
91772959|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.64||0.9133|TWO_SIDED|95.0|-3.4|3.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||3.04|-3.40|0.9133
91646089|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.0257|TWO_SIDED|95.0|1.02|1.43|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.02|0.0257
91772960|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.63||0.1078|TWO_SIDED|95.0|-5.85|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.58|-5.85|0.1078
91772961|NCT03192176|183427599|SUPERIORITY||LSMean differencce|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.0719|TWO_SIDED|95.0|-4.07|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.18|-4.07|0.0719
91772962|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.09||0.1298|TWO_SIDED|95.0|-3.8|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.49|-3.80|0.1298
91772963|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9532|TWO_SIDED|95.0|-2.26|2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.13|-2.26|0.9532
91772964|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.751|TWO_SIDED|95.0|-1.84|2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.55|-1.84|0.7510
91772965|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.11||0.112|TWO_SIDED|95.0|-3.95|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.42|-3.95|0.1120
91772966|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.1||0.9781|TWO_SIDED|95.0|-2.13|2.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.19|-2.13|0.9781
91772967|NCT03192176|183427599|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.206|TWO_SIDED|95.0|-3.57|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.77|-3.57|0.2060
91772968|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.5332|TWO_SIDED|95.0|-1.46|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.76|-1.46|0.5332
91772969|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4599|TWO_SIDED|95.0|-1.54|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.70|-1.54|0.4599
91772970|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.58||0.4752|TWO_SIDED|95.0|-0.72|1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.55|-0.72|0.4752
91772971|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.9051|TWO_SIDED|95.0|-1.21|1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.07|-1.21|0.9051
91772972|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||0.9937|TWO_SIDED|95.0|-1.14|1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.15|-1.14|0.9937
91772973|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.57||0.6956|TWO_SIDED|95.0|-0.91|1.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.35|-0.91|0.6956
91772974|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2302|TWO_SIDED|95.0|-1.81|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.44|-1.81|0.2302
91772975|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1544|TWO_SIDED|95.0|-1.55|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.25|-1.55|0.1544
91772976|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6847|TWO_SIDED|95.0|-1.1|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.72|-1.10|0.6847
91772977|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.552|TWO_SIDED|95.0|-1.2|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.64|-1.20|0.5520
91772978|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3632|TWO_SIDED|95.0|-1.36|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.50|-1.36|0.3632
91772979|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2828|TWO_SIDED|95.0|-1.43|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.42|-1.43|0.2828
91772980|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4702|TWO_SIDED|95.0|-1.24|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.58|-1.24|0.4702
91772981|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8262|TWO_SIDED|95.0|-1.02|0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.81|-1.02|0.8262
91772982|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3152|TWO_SIDED|95.0|-0.6|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.19|-0.60|0.3152
91772983|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4399|TWO_SIDED|95.0|-0.56|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.56|0.4399
91772984|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1898|TWO_SIDED|95.0|-0.67|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.13|-0.67|0.1898
91772985|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9791|TWO_SIDED|95.0|-0.4|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.41|-0.40|0.9791
91772986|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3178|TWO_SIDED|95.0|-0.61|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.20|-0.61|0.3178
91772987|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4174|TWO_SIDED|95.0|-0.57|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.57|0.4174
91772988|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.249|TWO_SIDED|95.0|-0.63|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.16|-0.63|0.2490
91772989|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.87||0.1233|TWO_SIDED|95.0|-6.57|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||0.79|-6.57|0.1233
91772990|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.2858|TWO_SIDED|95.0|-5.76|1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.70|-5.76|0.2858
91772991|NCT03192176|183427599|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.93||0.9716|TWO_SIDED|95.0|-3.87|3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.73|-3.87|0.9716
91772992|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.93||0.9072|TWO_SIDED|95.0|-3.58|4.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||4.03|-3.58|0.9072
91772993|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|1.92||0.2334|TWO_SIDED|95.0|-6.07|1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.49|-6.07|0.2334
91772994|NCT03192176|183427599|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.91||0.9859|TWO_SIDED|95.0|-3.79|3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.72|-3.79|0.9859
91772995|NCT03192176|183427599|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.287|TWO_SIDED|95.0|-5.77|1.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.72|-5.77|0.2870
91772996|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1632|TWO_SIDED|95.0|-1.41|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.24|-1.41|0.1632
91772997|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.42||0.0045|TWO_SIDED|95.0|-2.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.38|-2.03|0.0045
91772998|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.42||0.0002|TWO_SIDED|95.0|-2.43|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.77|-2.43|0.0002
91772999|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.7|-1.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-1.02|-2.70|<0.0001
91773000|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.8569|TWO_SIDED|95.0|-0.91|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.76|-0.91|0.8569
91773001|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.42||0.111|TWO_SIDED|95.0|-1.49|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.15|-1.49|0.1110
91773002|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0187|TWO_SIDED|95.0|-1.83|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.17|-1.83|0.0187
91773003|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4972|TWO_SIDED|95.0|-0.73|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.36|-0.73|0.4972
91773004|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2568|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2568
91773005|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2609|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2609
91773006|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4148|TWO_SIDED|95.0|-0.78|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.32|-0.78|0.4148
91773007|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5575|TWO_SIDED|95.0|-0.38|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.71|-0.38|0.5575
91773008|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1671|TWO_SIDED|95.0|-0.16|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.92|-0.16|0.1671
91773009|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9462|TWO_SIDED|95.0|-0.57|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.53|-0.57|0.9462
91773010|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0699|TWO_SIDED|95.0|-0.91|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.04|-0.91|0.0699
91773011|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.15|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.20|-1.15|0.0056
91773012|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1117|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1117
91773013|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0265|TWO_SIDED|95.0|-1.02|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.06|-1.02|0.0265
91773014|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1119|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1119
91773015|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7607|TWO_SIDED|95.0|-0.54|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.40|-0.54|0.7607
91773016|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0437|TWO_SIDED|95.0|-0.97|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.01|-0.97|0.0437
91773017|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0211|TWO_SIDED|95.0|-1.51|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.12|-1.51|0.0211
91773018|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.0017|TWO_SIDED|95.0|-1.82|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.42|-1.82|0.0017
91773019|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0598|TWO_SIDED|95.0|-1.37|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.03|-1.37|0.0598
91773020|NCT03192176|183427600|SUPERIORITY||LSMean differencce|-0.5|STANDARD_ERROR_OF_MEAN|0.36||0.1573|TWO_SIDED|95.0|-1.21|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.20|-1.21|0.1573
91773021|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.7257|TWO_SIDED|95.0|-0.83|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.58|-0.83|0.7257
91773022|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9324|TWO_SIDED|95.0|-0.72|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.66|-0.72|0.9324
91773023|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2172|TWO_SIDED|95.0|-1.14|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.26|-1.14|0.2172
91773024|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0742|TWO_SIDED|95.0|-0.88|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.88|0.0742
91773025|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0035|TWO_SIDED|95.0|-1.16|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Score||-0.23|-1.16|0.0035
91773026|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0266|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.06|-0.99|0.0266
91773027|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0124|TWO_SIDED|95.0|-1.06|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.13|-1.06|0.0124
91773028|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4367|TWO_SIDED|95.0|-0.65|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.28|-0.65|0.4367
91773029|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9318|TWO_SIDED|95.0|-0.48|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.44|-0.48|0.9318
91773030|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0714|TWO_SIDED|95.0|-0.89|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.89|0.0714
91773031|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.2027|TWO_SIDED|95.0|-1.35|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.29|-1.35|0.2027
91773032|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.41||0.0013|TWO_SIDED|95.0|-2.16|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.53|-2.16|0.0013
91773033|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.53|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.87|-2.53|<0.0001
91773034|NCT03192176|183427600|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.83|-1.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-1.16|-2.83|<0.0001
91773035|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.3791|TWO_SIDED|95.0|-1.19|0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.45|-1.19|0.3791
91773036|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0211|TWO_SIDED|95.0|-1.78|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.15|-1.78|0.0211
91773037|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|95.0|-2.1|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.47|-2.10|0.0021
91773038|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.889|TWO_SIDED|95.0|-0.55|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Psychological Mean Score||0.48|-0.55|0.8890
91773039|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5568|TWO_SIDED|95.0|-0.67|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.36|-0.67|0.5568
91773040|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3989|TWO_SIDED|95.0|-0.75|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.30|-0.75|0.3989
91773041|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6094|TWO_SIDED|95.0|-0.66|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.39|-0.66|0.6094
91773042|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5229|TWO_SIDED|95.0|-0.35|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.69|-0.35|0.5229
91773043|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4409|TWO_SIDED|95.0|-0.31|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.72|-0.31|0.4409
91773044|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.8062|TWO_SIDED|95.0|-0.45|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.58|-0.45|0.8062
91773045|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3663|TWO_SIDED|95.0|-0.71|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.26|-0.71|0.3663
91773046|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0424|TWO_SIDED|95.0|-0.99|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||-0.02|-0.99|0.0424
91519948|NCT00716092|182913991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|3.9||0.1274||95.0|-1.7|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-1.7|0.1274
91773047|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.1597|TWO_SIDED|95.0|-0.85|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.14|-0.85|0.1597
91773048|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0595|TWO_SIDED|95.0|-0.97|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.02|-0.97|0.0595
91773049|NCT03192176|183427600|SUPERIORITY||LSMean differnce|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2162|TWO_SIDED|95.0|-0.8|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.18|-0.80|0.2162
91773050|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9833|TWO_SIDED|95.0|-0.49|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.48|-0.49|0.9833
91773051|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2034|TWO_SIDED|95.0|-0.81|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.17|-0.81|0.2034
91773052|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9576|TWO_SIDED|95.0|-0.7|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.67|-0.70|0.9576
91773053|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.041|TWO_SIDED|95.0|-1.4|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||-0.03|-1.40|0.0410
91773054|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3961|TWO_SIDED|95.0|-1.0|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.40|-1.00|0.3961
91773055|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.5012|TWO_SIDED|95.0|-0.94|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.46|-0.94|0.5012
91773056|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2592|TWO_SIDED|95.0|-1.1|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.30|-1.10|0.2592
91773057|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6141|TWO_SIDED|95.0|-0.51|0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.86|-0.51|0.6141
91773058|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.439|TWO_SIDED|95.0|-0.95|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.41|-0.95|0.4390
91773059|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4521|TWO_SIDED|95.0|-0.64|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.29|-0.64|0.4521
91773060|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0257|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||-0.06|-0.99|0.0257
91773061|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0564|TWO_SIDED|95.0|-0.93|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.01|-0.93|0.0564
91773062|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0293|TWO_SIDED|95.0|-0.99|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Overall Mean Score||-0.05|-0.99|0.0293
91773063|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3742|TWO_SIDED|95.0|-0.68|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.26|-0.68|0.3742
91773064|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9106|TWO_SIDED|95.0|-0.49|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.44|-0.49|0.9106
91773065|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1844|TWO_SIDED|95.0|-0.78|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean SCore||0.15|-0.78|0.1844
91773066|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.0287|TWO_SIDED|95.0|-1.69|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.09|-1.69|0.0287
91773067|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0028|TWO_SIDED|95.0|-2.05|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.43|-2.05|0.0028
91773068|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.32|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.67|-2.32|0.0004
91773069|NCT03192176|183427600|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.87|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-1.22|-2.87|<0.0001
91773070|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1826|TWO_SIDED|95.0|-1.38|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.26|-1.38|0.1826
91773071|NCT03192176|183427600|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.0178|TWO_SIDED|95.0|-1.79|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.17|-1.79|0.0178
91773072|NCT03192176|183427600|SUPERIORITY||LSMean differnce|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0025|TWO_SIDED|95.0|-2.06|-0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.44|-2.06|0.0025
91773073|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9163|TWO_SIDED|95.0|-0.55|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.50|-0.55|0.9163
91773074|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.1597|TWO_SIDED|95.0|-0.92|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.15|-0.92|0.1597
91773075|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4871|TWO_SIDED|95.0|-0.74|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.35|-0.74|0.4871
91773076|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5401|TWO_SIDED|95.0|-0.72|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.38|-0.72|0.5401
91773077|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3788|TWO_SIDED|95.0|-0.3|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.79|-0.30|0.3788
91773078|NCT03192176|183427600|SUPERIORITY||0.28|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.4541|TWO_SIDED|95.0|-0.33|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.74|-0.33|0.4541
91773079|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9233|TWO_SIDED|95.0|-0.51|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.56|-0.51|0.9233
91773080|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6043|TWO_SIDED|95.0|-0.61|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.35|-0.61|0.6043
91773081|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1781|TWO_SIDED|95.0|-0.82|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.15|-0.82|0.1781
91773082|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5221|TWO_SIDED|95.0|-0.66|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.34|-0.66|0.5221
91773083|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.4744|TWO_SIDED|95.0|-0.68|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.32|-0.68|0.4744
91773084|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5167|TWO_SIDED|95.0|-0.66|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.66|0.5167
91773085|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3441|TWO_SIDED|95.0|-0.25|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.72|-0.25|0.3441
91773086|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5362|TWO_SIDED|95.0|-0.64|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.64|0.5362
91773087|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9349|TWO_SIDED|95.0|-0.78|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.71|-0.78|0.9349
91773088|NCT03192176|183427600|SUPERIORITY||LSMean differencce|-1.0|STANDARD_ERROR_OF_MEAN|0.39||0.0084|TWO_SIDED|95.0|-1.78|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||-0.26|-1.78|0.0084
91773089|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.1212|TWO_SIDED|95.0|-1.38|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.16|-1.38|0.1212
91773090|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7709|TWO_SIDED|95.0|-0.89|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.66|-0.89|0.7709
91773091|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1667|TWO_SIDED|95.0|-1.33|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.23|-1.33|0.1667
91773092|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9213|TWO_SIDED|95.0|-0.72|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.79|-0.72|0.9213
91773093|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.2315|TWO_SIDED|95.0|-1.21|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.29|-1.21|0.2315
91773094|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4731|TWO_SIDED|95.0|-0.63|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.29|-0.63|0.4731
91773095|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.031|TWO_SIDED|95.0|-0.98|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||-0.05|-0.98|0.0310
91773096|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.132|TWO_SIDED|95.0|-0.84|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.11|-0.84|0.1320
91773097|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1212|TWO_SIDED|95.0|-0.85|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.10|-0.85|0.1212
91773098|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.5689|TWO_SIDED|95.0|-0.62|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.34|-0.62|0.5689
91773099|NCT03192176|183427600|SUPERIORITY||0.1|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.734|TWO_SIDED|95.0|-0.39|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.55|-0.39|0.7340
91773100|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2704|TWO_SIDED|95.0|-0.73|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.20|-0.73|0.2704
91773101|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.561|TWO_SIDED|95.0|-1.24|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.67|-1.24|0.5610
91773102|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7966|TWO_SIDED|95.0|-0.83|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.09|-0.83|0.7966
91773103|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3965|TWO_SIDED|95.0|-0.56|1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.40|-0.56|0.3965
91773104|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8189|TWO_SIDED|95.0|-0.87|1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.10|-0.87|0.8189
91773105|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5693|TWO_SIDED|95.0|-1.27|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.70|-1.27|0.5693
91773106|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.5217|TWO_SIDED|95.0|-1.29|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.65|-1.29|0.5217
91773107|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2988|TWO_SIDED|95.0|-0.46|1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.48|-0.46|0.2988
91773108|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7957|TWO_SIDED|95.0|-0.69|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.69|0.7957
91773109|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.254|TWO_SIDED|95.0|-0.97|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.26|-0.97|0.2540
91773110|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.6956|TWO_SIDED|95.0|-0.75|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.50|-0.75|0.6956
91773111|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.8694|TWO_SIDED|95.0|-0.57|0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.68|-0.57|0.8694
91707805|NCT04227405|183308959|SUPERIORITY||Slope|0.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Common Dyadic Coping Subscale||||<.10
91707806|NCT04227405|183308959|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.37|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Negative Dyadic Coping Subscale||||<.10
91707807|NCT04227405|183308959|SUPERIORITY||Slope|-1.14|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping subscale||||<.05
91707808|NCT04227405|183308959|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Negative Dyadic Coping Scale||||>.05
91707809|NCT04227405|183308960|SUPERIORITY||Slope|0.57|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Supportive Dyadic Coping Subscale||||>.05
91707810|NCT04227405|183308960|SUPERIORITY||Slope|0.7|STANDARD_ERROR_OF_MEAN|0.37|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group for the Supportive Dyadic Coping Subscale||||<.05
91707811|NCT04227405|183308960|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Supportive Dyadic Coping Subscale||||>.05
91707812|NCT04227405|183308962|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Supportive Dyadic Coping Subcale||||>.05
91707813|NCT04227405|183308962|SUPERIORITY||Slope|1.45|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Supportive Dyadic Coping Scale||||<.001
91707814|NCT04227405|183308962|SUPERIORITY||Slope|1.42|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||<.01
91707815|NCT04227405|183308962|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Common Dyadic Coping Subscale||||>.05
91707816|NCT04227405|183308962|SUPERIORITY||Slope|2.12|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping Subscale||||<.001
91707817|NCT04227405|183308962|SUPERIORITY||Slope|1.91|STANDARD_ERROR_OF_MEAN|0.55|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Common Dyadic Coping subscale||||<.01
91707818|NCT04227405|183308962|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|0.42|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Negative Dyadic Coping Scale||||>.05
91707819|NCT04227405|183308962|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.53|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping Scale||||<.10
91707820|NCT04227405|183308962|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.65|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Negative Dyadic Coping Subscale||||>.05
91707821|NCT02187029|183309013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.55|||||TWO_SIDED|90.0|-56.32|-48.78|||Bayesian ANCOVA|||||-48.780|-56.320|
91707822|NCT02187029|183309013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.31|||||TWO_SIDED|90.0|-71.31|-61.54|||Bayesian ANCOVA|||||-61.540|-71.310|
91707823|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.55|-0.06|||Mixed Models Analysis|||Day 1, Hour 1||-0.06|-0.55|
91707824|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.95|-0.28|||Mixed Models Analysis|||Day 1, Hour 2||-0.28|-0.95|
91707825|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-1.52|-1.16|||Mixed Models Analysis|||Day 1, Hour 4||-1.16|-1.52|
91707826|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-2.38|-1.33|||Mixed Models Analysis|||Day 1, Hour 8||-1.33|-2.38|
91707827|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-2.18|-1.48|||Mixed Models Analysis|||Day 1, Hour 12||-1.48|-2.18|
91707828|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-2.11|-1.37|||Mixed Models Analysis|||Day 1, Hour 24||-1.37|-2.11|
91707829|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-2.89|-2.06|||Mixed Models Analysis|||Day 3||-2.06|-2.89|
91707830|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-3.29|-2.2|||Mixed Models Analysis|||Day 7, pre-dose||-2.20|-3.29|
91707831|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-3.39|-2.21|||Mixed Models Analysis|||Day 7, Hour 1||-2.21|-3.39|
91707832|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.06|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-3.72|-2.41|||Mixed Models Analysis|||Day 7, Hour 2||-2.41|-3.72|
91707833|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-4.03|-2.77|||Mixed Models Analysis|||Day7, Hour 4||-2.77|-4.03|
91707834|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.82|-2.79|||Mixed Models Analysis|||Day 7, Hour 8||-2.79|-3.82|
91707835|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.72|-2.68|||Mixed Models Analysis|||Day 7, Hour 12||-2.68|-3.72|
91707836|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-3.3|-2.32|||Mixed Models Analysis|||Day 7, Hour 24||-2.32|-3.30|
91707837|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.56|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-5.19|-3.92|||Mixed Models Analysis|||Day 11||-3.92|-5.19|
91707838|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-4.75|-3.88|||Mixed Models Analysis|||Day 14, pre-dose||-3.88|-4.75|
91707839|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.55|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.02|-4.08|||Mixed Models Analysis|||Day 14, Hour 1||-4.08|-5.02|
91707840|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-5.47|-4.47|||Mixed Models Analysis|||Day 14, Hour 2||-4.47|-5.47|
91707841|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-5.83|-5.02|||Mixed Models Analysis|||Day 14, Hour 4||-5.02|-5.83|
91707842|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.57|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-6.08|-5.05|||Mixed Models Analysis|||Day 14, Hour 8||-5.05|-6.08|
91707843|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.34|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-5.86|-4.82|||Mixed Models Analysis|||Day 14, Hour 12||-4.82|-5.86|
91707844|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.65|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.12|-4.18|||Mixed Models Analysis|||Day 14, Hour 24||-4.18|-5.12|
91707845|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.97|0.79|||Mixed Models Analysis|||Follow-up, Day 25-29||0.79|-2.97|
91707846|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.92|-0.32|||Mixed Models Analysis|||Day 1, Hour 1||-0.32|-0.92|
91707847|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-1.61|-0.75|||Mixed Models Analysis|||Day 1, Hour 2||-0.75|-1.61|
91707848|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-3.14|-2.69|||Mixed Models Analysis|||Day 1, Hour 4||-2.69|-3.14|
91707849|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-4.36|-3.03|||Mixed Models Analysis|||Day 1, Hour 8||-3.03|-4.36|
91707850|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-4.28|-3.4|||Mixed Models Analysis|||Day 1, Hour 12||-3.40|-4.28|
91707851|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.47|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-3.94|-3.0|||Mixed Models Analysis|||Day 1, Hour 24||-3.00|-3.94|
91707852|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-5.29|-4.23|||Mixed Models Analysis|||Day 3||-4.23|-5.29|
91773112|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.5047|TWO_SIDED|95.0|-0.84|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.41|-0.84|0.5047
91707853|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-6.62|-5.0|||Mixed Models Analysis|||Day 7, pre-dose||-5.00|-6.62|
91707854|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.84|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|90.0|-6.72|-4.95|||Mixed Models Analysis|||Day 7, Hour 1||-4.95|-6.72|
91707855|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-7.17|-5.19|||Mixed Models Analysis|||Day 7, Hour 2||-5.19|-7.17|
91707856|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.51|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-7.46|-5.55|||Mixed Models Analysis|||Day 7, Hour 4||-5.55|-7.46|
91707857|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-7.07|-5.51|||Mixed Models Analysis|||Day 7, Hour 8||-5.51|-7.07|
91707858|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-7.03|-5.44|||Mixed Models Analysis|||Day 7, Hour 12||-5.44|-7.03|
91707859|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.75|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-6.5|-4.99|||Mixed Models Analysis|||Day 7, Hour 24||-4.99|-6.50|
91707860|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-6.59|-4.65|||Mixed Models Analysis|||Day 11||-4.65|-6.59|
91707861|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-6.42|-5.1|||Mixed Models Analysis|||Day 14, pre-dose||-5.10|-6.42|
91707862|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-6.67|-5.24|||Mixed Models Analysis|||Day 14, Hour 1||-5.24|-6.67|
91707863|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-6.9|-5.38|||Mixed Models Analysis|||Day 14, Hour 2||-5.38|-6.90|
91707864|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-7.03|-5.81|||Mixed Models Analysis|||Day 14, Hour 4||-5.81|-7.03|
91707865|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.41|-5.87|||Mixed Models Analysis|||Day 14, Hour 8||-5.87|-7.41|
91707866|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.18|-5.63|||Mixed Models Analysis|||Day 14, Hour 12||-5.63|-7.18|
91707867|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-6.47|-5.07|||Mixed Models Analysis|||Day 14, Hour 24||-5.07|-6.47|
91773113|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7515|TWO_SIDED|95.0|-0.52|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.71|-0.52|0.7515
91707868|NCT02187029|183309018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|90.0|-4.96|-0.35|||Mixed Models Analysis|||Follow-up, Day 25-29||-0.35|-4.96|
91707869|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0355|STANDARD_ERROR_OF_MEAN|0.0423|||TWO_SIDED|90.0|-0.1103|0.0394|||Mixed Models Analysis|||Day 1, Hour 1||0.0394|-0.1103|
91707870|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0152|STANDARD_ERROR_OF_MEAN|0.0631|||TWO_SIDED|90.0|-0.1269|0.0966|||Mixed Models Analysis|||Day 1, Hour 2||0.0966|-0.1269|
91707871|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0331|STANDARD_ERROR_OF_MEAN|0.0422|||TWO_SIDED|90.0|-0.1078|0.0417|||Mixed Models Analysis|||Day 1, Hour 4||0.0417|-0.1078|
91707872|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0035|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.075|0.082|||Mixed Models Analysis|||Day 1, Hour 8||0.0820|-0.0750|
91707873|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0502|STANDARD_ERROR_OF_MEAN|0.0367|||TWO_SIDED|90.0|-0.1153|0.0149|||Mixed Models Analysis|||Day 1, Hour 12||0.0149|-0.1153|
91707874|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.0553|||TWO_SIDED|90.0|-0.1058|0.0899|||Mixed Models Analysis|||Day 1, Hour 24||0.0899|-0.1058|
91707875|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.0561|||TWO_SIDED|90.0|-0.1538|0.046|||Mixed Models Analysis|||Day 7, pre-dose||0.0460|-0.1538|
91707876|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0109|STANDARD_ERROR_OF_MEAN|0.0506|||TWO_SIDED|90.0|-0.0793|0.101|||Mixed Models Analysis|||Day 7, Hour 1||0.1010|-0.0793|
91707877|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.033|STANDARD_ERROR_OF_MEAN|0.0496|||TWO_SIDED|90.0|-0.0554|0.1213|||Mixed Models Analysis|||Day 7, Hour 2||0.1213|-0.0554|
91707878|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0086|STANDARD_ERROR_OF_MEAN|0.0459|||TWO_SIDED|90.0|-0.0733|0.0905|||Mixed Models Analysis|||Day 7, Hour 4||0.0905|-0.0733|
91707879|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0244|STANDARD_ERROR_OF_MEAN|0.0349|||TWO_SIDED|90.0|-0.0865|0.0378|||Mixed Models Analysis|||Day 7, Hour 8||0.0378|-0.0865|
91707880|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0526|STANDARD_ERROR_OF_MEAN|0.0251|||TWO_SIDED|90.0|-0.0973|-0.0079|||Mixed Models Analysis|||Day 7, Hour 12||-0.0079|-0.0973|
91707881|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0298|STANDARD_ERROR_OF_MEAN|0.0331|||TWO_SIDED|90.0|-0.0889|0.0292|||Mixed Models Analysis|||Day 7, Hour 24||0.0292|-0.0889|
91773114|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7818|TWO_SIDED|95.0|-0.7|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.70|0.7818
91773115|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.577|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.36|-0.65|0.5770
91773116|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1893|TWO_SIDED|95.0|-0.85|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.17|-0.85|0.1893
91773117|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2997|TWO_SIDED|95.0|-0.25|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.79|-0.25|0.2997
91773118|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7529|TWO_SIDED|95.0|-0.6|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.44|-0.60|0.7529
91773119|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4173|TWO_SIDED|95.0|-0.73|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.31|-0.73|0.4173
91773120|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4944|TWO_SIDED|95.0|-0.34|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.69|-0.34|0.4944
91773121|NCT03192176|183427600|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9231|TWO_SIDED|95.0|-0.54|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.49|-0.54|0.9231
91773122|NCT03192176|183427600|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.5112|TWO_SIDED|95.0|-1.04|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.52|-1.04|0.5112
91773123|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED|95.0|-1.66|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||-0.09|-1.66|0.0300
91773124|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.0634|TWO_SIDED|95.0|-1.57|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.04|-1.57|0.0634
91773125|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9406|TWO_SIDED|95.0|-0.78|0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.84|-0.78|0.9406
91773126|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1168|TWO_SIDED|95.0|-1.46|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.16|-1.46|0.1168
91773127|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9937|TWO_SIDED|95.0|-0.79|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.80|-0.79|0.9937
91773128|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1858|TWO_SIDED|95.0|-1.32|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.26|-1.32|0.1858
91773129|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.5765|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.36|-0.65|0.5765
91773130|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1848|TWO_SIDED|95.0|-0.86|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.17|-0.86|0.1848
91773131|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7299|TWO_SIDED|95.0|-0.43|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.61|-0.43|0.7299
91773132|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9415|TWO_SIDED|95.0|-0.54|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.54|0.9415
91773133|NCT03192176|183427600|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2742|TWO_SIDED|95.0|-0.82|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.23|-0.82|0.2742
91773134|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.6946|TWO_SIDED|95.0|-0.41|0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.62|-0.41|0.6946
91773135|NCT03192176|183427600|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9442|TWO_SIDED|95.0|-0.53|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.53|0.9442
91773136|NCT03631940|183427615|SUPERIORITY||Least squares mean difference|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||Hierarchical generalized linear mixed mo|Hierarchical generalized linear mixed models||||5.37|-6.36|.87
91773137|NCT00836589|183427626|NON_INFERIORITY|"Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).~Type I error (alpha) is 0.05 (one-sided for non-inferiority).~Statistical power is 80%."||||||0.002|||||||Binomial Proportion|||||||0.0020
91773138|NCT00117637|183427636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.5|TWO_SIDED|95.0|0.61|1.27||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.27|0.61|0.50
91773139|NCT00117637|183427637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.469|TWO_SIDED|95.0|0.628|1.239||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.239|0.628|0.469
91773140|NCT00117637|183427638|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.006
91773141|NCT00117637|183427639|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||the Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.0004
91773142|NCT00117637|183427641|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.022
91773143|NCT00117637|183427643|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.015
91773144|NCT00117637|183427645|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.073
91519949|NCT00716092|182913992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.7||0.313||95.0|-2.7|8.2|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||8.2|-2.7|0.3130
91773145|NCT00117637|183427647|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.067
91773146|NCT00117637|183427648|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.005
91773147|NCT00117637|183427649|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.001
91773148|NCT00117637|183427650|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.019
91773149|NCT00117637|183427659|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Log Rank|||||||0.014
91773150|NCT03324607|183427672|OTHER|||||||0.006|||||||Paired t-test|||||||0.006
91773151|NCT01890343|183427716|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.||||0.002
91773152|NCT00189098|183427728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-25.0|||||TWO_SIDED|95.0|-44.0|-6.0|||risk differences (RD)||Risk difference and 95% confidence intervals reported for 6 weeks follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||-6|-44|
91773153|NCT00189098|183427728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-34.0|4.0|||risk difference (RD)||Risk difference and confidence interval reported for 12 week follow-up|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||4|-34|
91773154|NCT00189098|183427728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-12.0|22.0|||risk difference (RD)||Risk difference and confidence interval reported for 1 year follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||22|-12|
91646090|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.254|TWO_SIDED|95.0|0.93|1.3|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.30|0.93|0.2540
91773155|NCT00189098|183427729|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-34.0|10.0|||rate differences (95%CI intervals)||Risk difference and confidence interval reported for eardrop usage between 6 and 12 weeks follow-up.|||10|-34|
91773156|NCT00189098|183427730|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-22.0|14.0|||rate difference (RD)||Risk difference and confidence interval reported for eardrop usage between 12 weeks and 1 year follow-up.|||14|-22|
91773157|NCT00189098|183427731|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-23.0|9.0|||Rate differences (95%CI interval)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 6 to 12 weeks follow-up.|||9|-23|
91773158|NCT00189098|183427732|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0|||||TWO_SIDED|95.0|-7.0|37.0|||Rate difference (RD)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 12 weeks and 1 year follow-up.|||37|-7|
91773159|NCT00189098|183427733|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-12.0|24.0|||Rate differences (95%CI intervals)||Risk difference and confidence interval reported for participants who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|||24|-12|
91773160|NCT00265564|183427761|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||We investigated treatment condition differences in change of drug and alcohol use over four time-points using generalized linear mixed modeling analyses. A trajectory for each participant was modeled yielding estimates of baseline scores (intercept), slope, and error. Four between-person parameters were estimated: average baseline score for all participants, average slope over time in TAU condition, effect of being in SS on average intercept, effect of being in SS on average slope.||||> .05
91773161|NCT00265564|183427762|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91773162|NCT00265564|183427763|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||Generalized linear mixed modeling analysis||||>.05
91773163|NCT00467740|183427790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0754||95.0|-0.008|0.167|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.167|-0.008|0.0754
91773164|NCT00467740|183427790|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.045||0.0571||95.0|-0.003|0.174|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.174|-0.003|0.0571
91773165|NCT00467740|183427790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.045||0.0906||95.0|-0.012|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.164|-0.012|0.0906
91773166|NCT00467740|183427790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.044||0.0011||95.0|0.059|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.059|0.0011
91773167|NCT00467740|183427791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.238|STANDARD_ERROR_OF_MEAN|7.843||0.0393||95.0|0.801|31.675|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||31.675|0.801|0.0393
91773168|NCT00467740|183427791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.878|STANDARD_ERROR_OF_MEAN|7.875||0.0005||95.0|12.379|43.378|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||43.378|12.379|0.0005
91773169|NCT00467740|183427791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.072|STANDARD_ERROR_OF_MEAN|7.906|<|0.0001||95.0|20.512|51.633|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||51.633|20.512|<0.0001
91773170|NCT00467740|183427791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.943|STANDARD_ERROR_OF_MEAN|7.848|<|0.0001||95.0|27.498|58.389|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||58.389|27.498|<0.0001
91773171|NCT00467740|183427792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.044||0.1264||95.0|-0.019|0.154|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.154|-0.019|0.1264
91773172|NCT00467740|183427792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.044||0.0232||95.0|0.014|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.188|0.014|0.0232
91773173|NCT00467740|183427792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0106||95.0|0.027|0.2|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.027|0.0106
91707882|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0167|STANDARD_ERROR_OF_MEAN|0.0268|||TWO_SIDED|90.0|-0.0649|0.0315|||Mixed Models Analysis|||Day 14, pre-dose||0.0315|-0.0649|
91773174|NCT00467740|183427792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.087|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.260|0.087|0.0001
91773175|NCT00467740|183427793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.048||0.0329||95.0|0.008|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.198|0.008|0.0329
91773176|NCT00467740|183427793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.048||0.0666||95.0|-0.006|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.184|-0.006|0.0666
91773177|NCT00467740|183427793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.048||0.3738||95.0|-0.052|0.137|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.052|0.3738
91773178|NCT00467740|183427793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.048||0.0037||95.0|0.046|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.046|0.0037
91773179|NCT00467740|183427794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.046||0.2646||95.0|-0.039|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.039|0.2646
91773180|NCT00467740|183427794|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3527||95.0|-0.048|0.135|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.135|-0.048|0.3527
91773181|NCT00467740|183427794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.046||0.1369||95.0|-0.022|0.16|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.160|-0.022|0.1369
91773182|NCT00467740|183427794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.046||0.0051||95.0|0.039|0.221|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.221|0.039|0.0051
91773183|NCT00467740|183427795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.053||0.017||95.0|0.023|0.232|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.232|0.023|0.0170
91773184|NCT00467740|183427795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.053||0.0646||95.0|-0.006|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.006|0.0646
91773185|NCT00467740|183427795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.053||0.602||95.0|-0.077|0.132|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.132|-0.077|0.6020
91773186|NCT00467740|183427795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.053||0.0147||95.0|0.026|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.233|0.026|0.0147
91773187|NCT00467740|183427796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4902||95.0|-0.068|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.068|0.4902
91773188|NCT00467740|183427796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.054||0.2832||95.0|-0.048|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.164|-0.048|0.2832
91773189|NCT00467740|183427796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.054||0.6516||95.0|-0.081|0.13|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.130|-0.081|0.6516
91773190|NCT00467740|183427796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.053||0.006||95.0|0.042|0.252|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.252|0.042|0.0060
91773191|NCT00467740|183427797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.05||0.0005||95.0|0.079|0.277|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.277|0.079|0.0005
91773192|NCT00467740|183427797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.051||0.007||95.0|0.038|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.038|0.0070
91773193|NCT00467740|183427797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.05||0.0512||95.0|-0.001|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.198|-0.001|0.0512
91773194|NCT00467740|183427797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.133|0.331|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.331|0.133|<0.0001
91646091|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5141|TWO_SIDED|95.0|0.76|1.75|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||1.75|0.76|0.5141
91519950|NCT00716092|182913993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|4.3||0.2281||95.0|-3.3|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-3.3|0.2281
91519951|NCT00716092|182913994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|STANDARD_ERROR_OF_MEAN|18.6||0.223||95.0|-14.0|59.5|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||59.5|-14.0|0.2230
91707883|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0616|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|0.001|0.1222|||Mixed Models Analysis|||Day 14, Hour 1||0.1222|0.0010|
91773195|NCT00467740|183427798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.061||0.1811||95.0|-0.039|0.203|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.203|-0.039|0.1811
91773196|NCT00467740|183427798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.062||0.2118||95.0|-0.044|0.199|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.199|-0.044|0.2118
91773197|NCT00467740|183427798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.062||0.5504||95.0|-0.085|0.158|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.158|-0.085|0.5504
91773198|NCT00467740|183427798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.062||0.0022||95.0|0.069|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.312|0.069|0.0022
91773199|NCT00467740|183427799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.102|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.255|0.102|<0.0001
91773200|NCT00467740|183427799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.260|0.106|<0.0001
91773201|NCT00467740|183427799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.096|0.25|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.250|0.096|<0.0001
91773202|NCT00467740|183427799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.214|0.367|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.367|0.214|<0.0001
91773203|NCT00467740|183427800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.101|0.279|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.279|0.101|<0.0001
91773204|NCT00467740|183427800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001||95.0|0.107|0.286|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.286|0.107|<0.0001
91773205|NCT00467740|183427800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.045||0.0007||95.0|0.067|0.246|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.246|0.067|0.0007
91773206|NCT00467740|183427800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.174|0.352|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.352|0.174|<0.0001
91519952|NCT02436330|182913995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0615||||0.0967|TWO_SIDED|95.0|-0.1344|0.0115||We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.|t-test, 2 sided|||||0.0115|-0.1344|0.0967
91519953|NCT02436330|182913996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0775||||0.0335|TWO_SIDED|95.0|-0.1485|-0.00652|||t-test, 2 sided|||||-0.00652|-0.1485|0.0335
91519954|NCT02436330|182913997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.991|TWO_SIDED|95.0|-5.2|5.1|||t-test, 2 sided|||||5.1|-5.2|0.991
91519955|NCT02436330|182913998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.851|TWO_SIDED|95.0|-9.0|11.0|||t-test, 2 sided|||||11|-9|0.851
91707884|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1025|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.0104|0.1945|||Mixed Models Analysis|||Day 14, Hour 2||0.1945|0.0104|
91519956|NCT02436330|182913999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.501|TWO_SIDED|95.0|-11.7|5.8|||t-test, 2 sided|||||5.8|-11.7|0.501
91773207|NCT00467740|183427801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.115|0.313|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.313|0.115|<0.0001
91773208|NCT00467740|183427801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.05||0.0021||95.0|0.057|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.255|0.057|0.0021
91773209|NCT00467740|183427801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.05||0.0795||95.0|-0.01|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.010|0.0795
91773210|NCT00467740|183427801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.326|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.326|0.129|<0.0001
91773211|NCT00467740|183427802|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.049||0.0003||95.0|0.082|0.276|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.276|0.082|0.0003
91773212|NCT00467740|183427802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.049||0.0077||95.0|0.035|0.229|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.229|0.035|0.0077
91773213|NCT00467740|183427802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.049||0.0427||95.0|0.003|0.197|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.003|0.0427
91773214|NCT00467740|183427802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.143|0.336|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.336|0.143|<0.0001
91773215|NCT00467740|183427803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.048||0.0005||95.0|0.074|0.263|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.263|0.074|0.0005
91773216|NCT00467740|183427803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.048||0.0003||95.0|0.08|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.269|0.080|0.0003
91773217|NCT00467740|183427803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.268|0.078|0.0004
91773218|NCT00467740|183427803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.202|0.39|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.390|0.202|<0.0001
91773219|NCT00467740|183427804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.268|0.078|0.0004
91773220|NCT00467740|183427804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.048||0.0002||95.0|0.09|0.281|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.281|0.090|0.0002
91519957|NCT02436330|182914000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2971||||0.035|TWO_SIDED|95.0|0.0224|0.5718|||t-test, 2 sided|||||0.5718|0.0224|0.035
91519958|NCT02436330|182914001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9464||||0.2207|TWO_SIDED|95.0|-2.4954|0.6025|||t-test, 2 sided|||||0.6025|-2.4954|0.2207
91773221|NCT00467740|183427804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.048||0.0047||95.0|0.043|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.043|0.0047
91773222|NCT00467740|183427804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.142|0.332|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.332|0.142|<0.0001
91773223|NCT00467740|183427805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.055||0.0002||95.0|0.096|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.312|0.096|0.0002
91773224|NCT00467740|183427805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.055||0.0057||95.0|0.045|0.261|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.261|0.045|0.0057
91519959|NCT02436330|182914002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0491||||0.4164|TWO_SIDED|95.0|-3.6407|1.5425|||t-test, 2 sided|||||1.5425|-3.6407|0.4164
91519960|NCT02436330|182914003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2433.7||||0.812|TWO_SIDED|95.0|-18579.7|23447.2|||t-test, 2 sided|||||23447.2|-18579.7|0.812
91519961|NCT02436330|182914004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2837||||0.3326|TWO_SIDED|95.0|-0.3037|0.8711|||t-test, 2 sided|||||0.8711|-0.3037|0.3326
91519962|NCT02436330|182914005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2995||||0.1856|TWO_SIDED|95.0|-0.2051|0.8041|||t-test, 2 sided|||||0.8041|-0.2051|0.1856
91519963|NCT02436330|182914006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-247.9||||0.0849|TWO_SIDED|95.0|-531.7|35.8686|||t-test, 2 sided|||||35.8686|-531.7|0.0849
91519964|NCT02436330|182914007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.2048||||0.176|TWO_SIDED|95.0|-10.3835|1.974|||t-test, 2 sided|||||1.9740|-10.3835|0.176
91519965|NCT02436330|182914008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.2151||||0.0247|TWO_SIDED|95.0|0.973|13.457|||t-test, 2 sided|||||13.457|0.973|0.0247
91773225|NCT00467740|183427805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.055||0.1513||95.0|-0.029|0.186|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.186|-0.029|0.1513
91773226|NCT00467740|183427805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001||95.0|0.114|0.328|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.328|0.114|<0.0001
91773227|NCT00467740|183427806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.054||0.0022||95.0|0.06|0.271|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.271|0.060|0.0022
91773228|NCT00467740|183427806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.0307||95.0|0.011|0.223|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.223|0.011|0.0307
91773229|NCT00467740|183427806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.054||0.132||95.0|-0.025|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.025|0.1320
91773230|NCT00467740|183427806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001||95.0|0.127|0.337|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.337|0.127|<0.0001
91773231|NCT00467740|183427807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.056||0.1585||95.0|-0.031|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.188|-0.031|0.1585
91773232|NCT00467740|183427807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0848||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.207|-0.013|0.0848
91773233|NCT00467740|183427807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0838||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.207|-0.013|0.0838
91773234|NCT00467740|183427807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.056||0.0014||95.0|0.07|0.289|||Mixed Models Analysis||Olo 20 mcg qd minus Placebo|||0.289|0.070|0.0014
91773235|NCT00467740|183427808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.059||0.0959||95.0|-0.018|0.216|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.216|-0.018|0.0959
91773236|NCT00467740|183427808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.06||0.047||95.0|0.002|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.002|0.0470
91773237|NCT00467740|183427808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.06||0.196||95.0|-0.04|0.195|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.195|-0.040|0.1960
91773238|NCT00467740|183427808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.059||0.002||95.0|0.068|0.302|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.302|0.068|0.0020
91773239|NCT00467740|183427809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.064||0.027||95.0|0.016|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.269|0.016|0.0270
91773240|NCT00467740|183427809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.065||0.1031||95.0|-0.021|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.233|-0.021|0.1031
91773241|NCT00467740|183427809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.064||0.4378||95.0|-0.077|0.177|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.177|-0.077|0.4378
91773242|NCT00467740|183427809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.064||0.0064||95.0|0.05|0.303|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.303|0.050|0.0064
91773243|NCT00467740|183427810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.069||0.2781||95.0|-0.061|0.21|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.210|-0.061|0.2781
91773244|NCT00467740|183427810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.069||0.3284||95.0|-0.068|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.068|0.3284
91773245|NCT00467740|183427810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.069||0.602||95.0|-0.1|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.100|0.6020
91773246|NCT00467740|183427810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.069||0.0006||95.0|0.104|0.375|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.375|0.104|0.0006
91773247|NCT00467740|183427811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.067||0.4331|TWO_SIDED|95.0|-0.079|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.184|-0.079|0.4331
91773248|NCT00467740|183427811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.068||0.515|TWO_SIDED|95.0|-0.089|0.178|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.178|-0.089|0.5150
91773249|NCT00467740|183427811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.068||0.5714|TWO_SIDED|95.0|-0.095|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.095|0.5714
91773250|NCT00467740|183427811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.068||0.0177|TWO_SIDED|95.0|0.028|0.296|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.296|0.028|0.0177
91773251|NCT00467740|183427812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|7.665||0.003|TWO_SIDED|95.0|7.883|38.057|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||38.057|7.883|0.0030
91519966|NCT02436330|182914009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8169||||0.2764|TWO_SIDED|95.0|-2.4147|0.7808|||t-test, 2 sided|||||0.7808|-2.4147|0.2764
91773252|NCT00467740|183427812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.6|STANDARD_ERROR_OF_MEAN|7.7||0.0016|TWO_SIDED|95.0|9.446|39.754|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||39.754|9.446|0.0016
91773253|NCT00467740|183427812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.806|STANDARD_ERROR_OF_MEAN|7.727|<|0.0001|TWO_SIDED|95.0|21.598|52.015|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||52.015|21.598|<.0001
91773254|NCT00467740|183427812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.505|STANDARD_ERROR_OF_MEAN|7.675|<|0.0001|TWO_SIDED|95.0|27.399|57.611|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||57.611|27.399|<.0001
91773255|NCT00467740|183427813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118|STANDARD_ERROR_OF_MEAN|1.055||0.2898|TWO_SIDED|95.0|-3.194|0.957|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.957|-3.194|0.2898
91773256|NCT00467740|183427813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.351|STANDARD_ERROR_OF_MEAN|1.057||0.027|TWO_SIDED|95.0|-4.432|-0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||-0.269|-4.432|0.0270
91773257|NCT00467740|183427813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.045|STANDARD_ERROR_OF_MEAN|1.063||0.0045|TWO_SIDED|95.0|-5.138|-0.952|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||-0.952|-5.138|0.0045
91773258|NCT00467740|183427813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.937|STANDARD_ERROR_OF_MEAN|1.053||0.0056|TWO_SIDED|95.0|-5.01|-0.865|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||-0.865|-5.010|0.0056
91773259|NCT00467740|183427814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.257||0.2645|TWO_SIDED|95.0|-0.793|0.218|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.218|-0.793|0.2645
91773260|NCT00467740|183427814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.258||0.0423|TWO_SIDED|95.0|-1.034|-0.018|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.018|-1.034|0.0423
91773261|NCT00467740|183427814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.332|STANDARD_ERROR_OF_MEAN|0.259||0.2008|TWO_SIDED|95.0|-0.842|0.178|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.178|-0.842|0.2008
91773262|NCT00467740|183427814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.593|STANDARD_ERROR_OF_MEAN|0.257||0.0218|TWO_SIDED|95.0|-1.098|-0.087|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.087|-1.098|0.0218
91773263|NCT00467740|183427823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142|STANDARD_ERROR_OF_MEAN|0.114||0.2156||95.0|-0.368|0.083|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.083|-0.368|0.2156
91773264|NCT00467740|183427823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.114||0.0869||95.0|-0.422|0.029|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.029|-0.422|0.0869
91773265|NCT00467740|183427823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.114||0.0044||95.0|-0.552|-0.103|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.103|-0.552|0.0044
91773266|NCT00467740|183427823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.113||0.0158||95.0|-0.499|-0.052|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.052|-0.499|0.0158
91773267|NCT02374164|183427892|SUPERIORITY_OR_OTHER||Point Estimate|0.72|||||TWO_SIDED|90.0|0.612|0.847|||||Ratio Fed/Fasted. Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural logarithm-transformed data. Bioequivalence was reached if the value was 0.80 to 1.25.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in the fasted and fed (high-fat meal) states.||0.847|0.612|
91773268|NCT00844376|183427898|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.77||||||90.0|85.82|106.88|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUC48 was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUC48; restricted (residual) maximum likelihood (REML) method of estimation.||106.88|85.82|
91773269|NCT00844376|183427899|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.04||||||90.0|84.99|106.27|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUCinf||106.27|84.99|
91773270|NCT00844376|183427900|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|94.86||||||90.0|83.86|107.29|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUClast||107.29|83.86|
91773271|NCT00844376|183427901|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|117.9||||||90.0|98.22|141.53|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for Cmax||141.53|98.22|
91773272|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|1.07||||0.009|TWO_SIDED|95.0|0.85|1.36||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot B||1.36|0.85|0.009
91773273|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.91||||0.009|TWO_SIDED|0.91|0.71|1.15||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot C||1.15|0.71|0.009
91773274|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.009|TWO_SIDED|95.0|0.67|1.07|||ANOVA|Threshold for significance of p value was 0.05.||A/Solomon Islands (H1N1): FluBlok: Lot B versus FluBlok: Lot C||1.07|0.67|0.009
91773275|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|2.03||||0.065|TWO_SIDED|95.0|1.56|2.64||Threshold of significance for p value was 0.05.|ANOVA|||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot B||2.64|1.56|0.065
91773276|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|1.63||||0.065|TWO_SIDED|95.0|1.26|2.11|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot C||2.11|1.26|0.065
91773277|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.8||||0.065|TWO_SIDED|95.0|0.62|1.04|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot B versus FluBlok: Lot C||1.04|0.62|0.065
91773278|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|0.88||||0.011|TWO_SIDED|95.0|0.69|1.13|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot B||1.13|0.69|0.011
91773279|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.011|TWO_SIDED|95.0|0.65|1.09|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot C||1.09|0.65|0.011
91773280|NCT00539981|183427909|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.96||||0.011|TWO_SIDED|95.0|0.75|1.23|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot B versus FluBlok: Lot C||1.23|0.75|0.011
91773281|NCT00539981|183427910|SUPERIORITY|Relative protective efficacy is equivalent to absolute efficacy which is defined as the reduction in the influenza rate for Flublok relative to placebo.|Relative protective efficacy|75.4|||||TWO_SIDED|95.0|-148.0|99.5||||||FluBlok versus Placebo||99.5|-148.0|
91773282|NCT03069352|183427924|SUPERIORITY||Hazard Ratio (HR)|0.749||||0.114|TWO_SIDED|95.0|0.524|1.071|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||1.071|0.524|0.114
91773283|NCT03069352|183427924|SUPERIORITY||Hazard Ratio (HR)|0.743||||0.103|TWO_SIDED|95.0|0.521|1.061|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.061|0.521|0.103
91773284|NCT03069352|183427925|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
91773285|NCT03069352|183427925|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91773286|NCT03069352|183427926|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
91773287|NCT03069352|183427926|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91773288|NCT03069352|183427927|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
91773289|NCT03069352|183427927|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91773290|NCT03069352|183427928|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
91773291|NCT03069352|183427928|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91773292|NCT03069352|183427929|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
91773293|NCT03069352|183427929|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91773294|NCT03069352|183427930|OTHER||LS Mean Difference|-4.507|STANDARD_ERROR_OF_MEAN|2.068|||TWO_SIDED|95.0|-8.6|-0.41|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3, Day 1||-0.41|-8.60|
91773295|NCT03069352|183427930|OTHER||LS Mean Difference|-4.923|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-10.03|0.19|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||0.19|-10.03|
91773296|NCT03069352|183427930|OTHER||LS Mean Difference|-0.807|STANDARD_ERROR_OF_MEAN|2.609|||TWO_SIDED|95.0|-5.98|4.36|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||4.36|-5.98|
91773297|NCT03069352|183427930|OTHER||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|3.176|||TWO_SIDED|95.0|-7.94|4.64|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 day 1||4.64|-7.94|
91773298|NCT03069352|183427930|SUPERIORITY|||||||0.126|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.126
91773299|NCT03069352|183427931|OTHER||LS Mean Difference|2.917|STANDARD_ERROR_OF_MEAN|4.617|||TWO_SIDED|95.0|-6.23|12.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3 Day 1||12.06|-6.23|
91773300|NCT03069352|183427931|OTHER||LS Mean Difference|13.388|STANDARD_ERROR_OF_MEAN|5.659|||TWO_SIDED|95.0|2.18|24.59|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||24.59|2.18|
91773301|NCT03069352|183427931|OTHER||LS Mean Difference|7.119|STANDARD_ERROR_OF_MEAN|6.031|||TWO_SIDED|95.0|-4.83|19.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||19.06|-4.83|
91773302|NCT03069352|183427931|OTHER||LS Mean Difference|6.381|STANDARD_ERROR_OF_MEAN|7.511|||TWO_SIDED|95.0|-8.49|21.26|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 Day 1||21.26|-8.49|
91773303|NCT03069352|183427931|SUPERIORITY|||||||0.085|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.085
91773304|NCT03069352|183427932|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.002|TWO_SIDED|95.0|0.416|0.817|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.817|0.416|0.002
91773305|NCT03069352|183427932|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.003|TWO_SIDED|95.0|0.43|0.839|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||0.839|0.430|0.003
91773306|NCT03069352|183427933|SUPERIORITY||Treatment Difference|22.9||||0.001|TWO_SIDED|95.0|10.8|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||35.0|10.8|0.001
91773307|NCT03069352|183427933|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91773308|NCT03069352|183427934|SUPERIORITY||Treatment Difference|15.2||||0.04|TWO_SIDED|95.0|1.4|29.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||29.0|1.4|0.040
91773309|NCT03069352|183427934|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
91519967|NCT02436330|182914010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7958||||0.0008|TWO_SIDED|95.0|-1.235|-0.3566|||t-test, 2 sided|||||-0.3566|-1.2350|0.0008
91773310|NCT03069352|183427935|SUPERIORITY||Treatment Difference|22.4|||||TWO_SIDED|95.0|9.0|35.8||||||||35.8|9.0|
91773311|NCT03069352|183427936|SUPERIORITY||Slope|17.7|||||TWO_SIDED|95.0|-0.4|35.8||||||||35.8|-0.4|
91773312|NCT03069352|183427937|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
91773313|NCT03069352|183427937|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
91773314|NCT03069352|183427938|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
91773315|NCT03069352|183427938|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
91773316|NCT03069352|183427942|OTHER||Hazard Ratio (HR)|0.704||||0.04|TWO_SIDED|95.0|0.503|0.985|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.985|0.503|0.040
91773317|NCT03069352|183427942|OTHER||Hazard Ratio (HR)|0.717||||0.049|TWO_SIDED|95.0|0.514|1.0|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.000|0.514|0.049
91519968|NCT02436330|182914011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7024||||0.6974|TWO_SIDED|95.0|-2.9377|4.3425|||t-test, 2 sided|||||4.3425|-2.9377|0.6974
91773318|NCT04906499|183427961|OTHER||Cohen's d effect size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||||||||0.93|-0.68|
91773319|NCT04906499|183427963|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.44|1.24||||||||1.24|-0.44|
91773320|NCT04906499|183427965|OTHER||Cohen's d effect size|0.85|||||TWO_SIDED|95.0|-0.13|1.77||||||||1.77|-0.13|
91773321|NCT04906499|183427967|OTHER||Cohen's d effect size|0.97|||||TWO_SIDED|95.0|-0.05|1.93||||||||1.93|-0.05|
91773322|NCT04906499|183427969|OTHER||Pearson's r Correlation Coefficient|0.32|||||TWO_SIDED|95.0|-0.67|0.9||||||||0.90|-0.67|
91773323|NCT04906499|183427970|OTHER||Pearson's r Correlation Coefficient|0.55|||||TWO_SIDED|95.0|-0.48|0.94||||||||0.94|-0.48|
91773324|NCT04906499|183427971|OTHER||Pearson's r Correlation Coefficient|0.23|||||TWO_SIDED|95.0|-0.88|0.71||||||||0.71|-0.88|
91773325|NCT04906499|183427972|OTHER||Pearson's r Correlation Coefficient|-0.19|||||TWO_SIDED|95.0|-0.87|0.73||||||||0.73|-0.87|
91773326|NCT04906499|183427974|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|95.0|-1.24|0.44||||||||0.44|-1.24|
91773327|NCT03346434|183427986|SUPERIORITY||Percentage difference|23.8|||<|0.0001|TWO_SIDED|95.0|13.27|34.37||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||34.37|13.27|< 0.0001
91773328|NCT03346434|183427987|SUPERIORITY||Percentage difference|42.3|||<|0.0001|TWO_SIDED|95.0|29.47|55.16||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||55.16|29.47|< 0.0001
91773329|NCT03346434|183427996|SUPERIORITY||Least Square (LS) Mean Difference|-50.4|||<|0.0001|TWO_SIDED|95.0|-62.38|-38.4||Threshold for significance at 0.05 level.|ANCOVA|||||-38.40|-62.38|< 0.0001
91773330|NCT03346434|183427997|SUPERIORITY||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|95.0|-59.47|-34.79||Threshold for significance at 0.05 level.|ANCOVA|||||-34.79|-59.47|< 0.0001
91773331|NCT03346434|183427998|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|26.18|52.27||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||52.27|26.18|< 0.0001
91773332|NCT03346434|183427999|SUPERIORITY||Percentage difference|43.3|||<|0.0001|TWO_SIDED|95.0|30.03|56.67||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||56.67|30.03|< 0.0001
91773333|NCT03346434|183428000|SUPERIORITY||Percentage difference|48.5|||<|0.0001|TWO_SIDED|95.0|35.03|62.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||62.00|35.03|< 0.0001
91773334|NCT03346434|183428001|SUPERIORITY||Percentage difference|22.5|||=|0.0001|TWO_SIDED|95.0|12.37|32.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||32.60|12.37|= 0.0001
91773335|NCT03346434|183428002|SUPERIORITY||LS Mean Difference|-24.27|||<|0.0001|TWO_SIDED|95.0|-31.204|-17.329||Threshold for significance at 0.05 level.|ANCOVA|||||-17.329|-31.204|< 0.0001
91773336|NCT03346434|183428003|SUPERIORITY||LS Mean Difference|-9.1|||<|0.0001|TWO_SIDED|95.0|-11.26|-6.89||Threshold for significance at 0.05 level.|ANCOVA|||||-6.89|-11.26|< 0.0001
91773337|NCT03346434|183428004|SUPERIORITY||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|95.0|-46.65|-30.21||Threshold for significance at 0.05 level.|ANCOVA|||||-30.21|-46.65|< 0.0001
91773338|NCT03346434|183428005|SUPERIORITY||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.093|2.317||Threshold significance was at 0.05 level.|ANCOVA|||||2.317|1.093|< 0.0001
91773339|NCT03346434|183428006|SUPERIORITY||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.029|-2.6||Threshold significance at 0.05 level.|ANCOVA|||||-2.600|-4.029|< 0.0001
91773340|NCT03346434|183428007|SUPERIORITY||LS Mean Difference|-7.8|||<|0.0001|TWO_SIDED|95.0|-9.789|-5.814||Threshold significance at 0.05 level.|ANCOVA|||||-5.814|-9.789|< 0.0001
91773341|NCT03346434|183428008|SUPERIORITY||LS Mean Difference|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.29|-4.75||Threshold significance at 0.05 level.|ANCOVA|||||-4.75|-10.29|< 0.0001
91773342|NCT03346434|183428009|SUPERIORITY||LS Mean Difference|-8.96|||<|0.0001|TWO_SIDED|95.0|-11.711|-6.202||Threshold significance at 0.05 level.|ANCOVA|||||-6.202|-11.711|< 0.0001
91773343|NCT03346434|183428010|SUPERIORITY||||||=|0.0015||||||Threshold significance is at 0.05 level.|ANCOVA|||||||= 0.0015
91773344|NCT03346434|183428011|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0997|TWO_SIDED|95.0|-6.35|0.56||Threshold significance at 0.05 level.|ANCOVA|||||0.56|-6.35|= 0.0997
91773345|NCT01751061|183428046|SUPERIORITY|To test the primary hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|||||<|0.05||||||P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.|GEE|||We estimated that 210 patients (315 surrogates, assuming \~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.||||<0.05
91773346|NCT01751061|183428047|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||Generalized linear model.||||<0.05
91773347|NCT01751061|183428048|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||||||<0.05
91773348|NCT01751061|183428049|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
91773349|NCT01751061|183428050|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
91773350|NCT01751061|183428051|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
91773351|NCT01751061|183428052|SUPERIORITY||||||<|0.05||||||P values were calculated.|GEE|||To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.||||<0.05
91773352|NCT05635461|183428077|OTHER||Geometric Mean Ratio|60.13|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
91773353|NCT05635461|183428078|OTHER||Geometric Mean Ratio|60.12|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
91773354|NCT05635461|183428079|OTHER||Geometric Mean Ratio|27.94|||||TWO_SIDED|90.0|25.09|31.13|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||31.13|25.09|
91773355|NCT05635461|183428080|OTHER||Median Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|90.0|0.9265|2.247|||ANOVA|||||2.2470|0.9265|<0.0001
91773356|NCT05635461|183428080|OTHER||Median Difference (Final Values)|2.78|||<|0.0001|TWO_SIDED|90.0|2.4475|3.0035|||ANOVA|||||3.0035|2.4475|<0.0001
91773357|NCT05635461|183428081|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0||||||||0.000|0.000|
91773358|NCT05635461|183428081|OTHER||Median Difference (Final Values)|0.25||||0.001|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0010
91773359|NCT05635461|183428082|OTHER||Geometric Mean Ratio|161.57|||||TWO_SIDED|90.0|150.96|172.92|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.92|150.96|
91519969|NCT02436330|182914013|SUPERIORITY_OR_OTHER|||||||0.2122|TWO_SIDED||||||t-test, 2 sided|||||||0.2122
91773360|NCT05635461|183428083|OTHER||Geometric Mean Ratio|161.59|||||TWO_SIDED|90.0|150.98|172.95|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.95|150.98|
91773361|NCT05635461|183428084|OTHER||Geometric Mean Ratio|304.19|||||TWO_SIDED|90.0|273.51|338.31|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||338.31|273.51|
91773362|NCT05635461|183428085|OTHER||Median Difference (Final Values)|0.99||||0.0662|TWO_SIDED|90.0|0.006|1.537|||ANOVA|||||1.5370|0.0060|0.0662
91773363|NCT05635461|183428086|OTHER||Median Difference (Final Values)|0.25||||0.0039|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0039
91773364|NCT00614575|183428089|SUPERIORITY_OR_OTHER||Mean change from baseline|-7.2|STANDARD_DEVIATION|9.0|<|0.0001|||||||Paired t-test|||||||<0.0001
91773365|NCT00614575|183428090|SUPERIORITY_OR_OTHER||Mean change from baseline|-4.8|STANDARD_DEVIATION|7.8|<|0.0001|||||||Paired t-test|||||||<0.0001
91773366|NCT00614575|183428091|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.7|STANDARD_DEVIATION|0.9|<|0.0001|||||||paired t-test|||||||<0.0001
91773367|NCT00614575|183428092|SUPERIORITY_OR_OTHER||mean change from baseline|-0.3|STANDARD_DEVIATION|0.6|<|0.0001|||||||paired t-test|||||||<0.0001
91773368|NCT00189540|183428094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 3.||||0.35
91773369|NCT00189540|183428094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 6.||||0.17
91773370|NCT00189540|183428095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Fisher Exact|||The comparison of groups at Month 3||||0.55
91773371|NCT00189540|183428095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Fisher Exact|||The comparison of groups at Month 6.||||0.28
91773372|NCT00189540|183428096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANCOVA|||Comparison between groups at Month 3||||0.2
91773373|NCT00189540|183428096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||ANCOVA|||Comparison between groups at Month 6||||0.04
91773374|NCT00189540|183428097|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
91773375|NCT00189540|183428098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||ANCOVA|||Comparison at Month 3||||0.77
91773376|NCT00189540|183428098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||95.0|||||ANCOVA|||Comparison at Month 6||||0.45
91773377|NCT00189540|183428099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 3 versus baseline.||||0.06
91773378|NCT00189540|183428099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 6 versus baseline.||||0.05
91773379|NCT03882021|183428108|OTHER||Kaplan Meier Survival Estimate|57.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|51.2|62.8|||||Kaplan-Meier estimate of freedom from recurrence after removal from AAD at one year.|||62.8|51.2|
91773380|NCT03882021|183428109|OTHER|Kaplan Meier Estimate of freedom from symptomatic recurrence.|Kaplan-Meier Survival Estimate|61.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|55.8|67.1|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT recurrence after removal from AAD|||67.1|55.8|
91773381|NCT03882021|183428110|OTHER|Kaplan Meier estimate of single procedure clinical success.|Kaplan-Meier Survival Estimate|79.4|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|74.2|83.6|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT without new or increased dose of Class I/III AAD at one year.|||83.6|74.2|
91773382|NCT03882021|183428111|OTHER|Kaplan Meier estimate of freedom from AF/AFL/AT|Kaplan Meier Survival Estimate|75.5|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|69.9|80.1|||||Kaplan Meier estimate of freedom from AF/AFL/AT at 12 months.|||80.1|69.9|
91773383|NCT00286442|183428117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.32||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.32|-0.68|<0.001
91773384|NCT00286442|183428117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.67|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming SD=0.8%, 2-sided test at 0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.30|-0.67|<0.001
91773385|NCT00286442|183428118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.37|-0.16||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.37|<0.001
91773386|NCT00286442|183428118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.19||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.40|<0.001
91773387|NCT00286442|183428119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
91773388|NCT00286442|183428119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
91773389|NCT00286442|183428120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
91773390|NCT00286442|183428120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
91773391|NCT00286442|183428121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.70|<0.001
91773392|NCT00286442|183428121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
91773393|NCT00286442|183428122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
91773394|NCT00286442|183428122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
91773395|NCT00286442|183428123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-20.7|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-6.8|-20.7|<0.001
91519970|NCT02436330|182914014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.61||||0.1265|TWO_SIDED|95.0|-1.15|8.33|||t-test, 2 sided|||||8.33|-1.15|0.1265
91519971|NCT02436330|182914015|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||t-test, 2 sided|||||||0.3671
91519972|NCT02436330|182914016|SUPERIORITY_OR_OTHER|||||||0.4892|TWO_SIDED||||||t-test, 2 sided|||||||0.4892
91519973|NCT00677235|182914031|SUPERIORITY_OR_OTHER|||||||0.449|||||||Fisher Exact|||||||0.449
91519974|NCT05120115|182914042|EQUIVALENCE|Examined differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|ANOVA|||||||0.05
91773396|NCT00286442|183428123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||<|0.001|TWO_SIDED|95.0|-18.9|-4.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-4.9|-18.9|<0.001
91773397|NCT00286442|183428124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-23.9|-9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.5|-23.9|<0.001
91773398|NCT00286442|183428124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-24.1|-9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.6|-24.1|<0.001
91773399|NCT00286442|183428125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-24.6|-11.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.0|-24.6|<0.001
91773400|NCT00286442|183428125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-24.3|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-24.3|<0.001
91773401|NCT00286442|183428126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||<|0.001|TWO_SIDED|95.0|-28.0|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-28.0|<0.001
91773402|NCT00286442|183428126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-25.6|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-25.6|<0.001
91773403|NCT00286442|183428127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-25.6|-8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.9|-25.6|<0.001
91773404|NCT00286442|183428127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.4|-8.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.6|-25.4|<0.001
91773405|NCT00286442|183428128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-27.4|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-27.4|<0.001
91773406|NCT00286442|183428128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.0|-8.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-25.0|<0.001
91773407|NCT00286442|183428129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.1|||<|0.001|TWO_SIDED|95.0|-26.7|-9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.4|-26.7|<0.001
91773408|NCT00286442|183428129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-24.2|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.8|-24.2|<0.001
91773409|NCT00286442|183428130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.3|-10.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.2|-27.3|<0.001
91773410|NCT00286442|183428130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.9|-8.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.8|-25.9|<0.001
91773411|NCT00286442|183428131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372|||<|0.001|TWO_SIDED|95.0|0.213|0.65||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.650|0.213|<0.001
91773412|NCT00286442|183428131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.405||||0.002|TWO_SIDED|95.0|0.231|0.708||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.708|0.231|0.002
91773413|NCT00286442|183428132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.302||||0.002|TWO_SIDED|95.0|0.143|0.635||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.635|0.143|0.002
91773414|NCT00286442|183428132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.236|||<|0.001|TWO_SIDED|95.0|0.109|0.51|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.510|0.109|<0.001
91773415|NCT00286442|183428133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.634|TWO_SIDED|95.0|-7.4|4.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-7.4|0.634
91773416|NCT00286442|183428133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.136|TWO_SIDED|95.0|-10.5|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-10.5|0.136
91773417|NCT00286442|183428134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.274|TWO_SIDED|95.0|-6.9|2.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.0|-6.9|0.274
91773418|NCT00286442|183428134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.046|TWO_SIDED|95.0|-9.1|-0.1||No multiplicity adjustments.|ANCOVA||Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-9.1|0.046
91773419|NCT00286442|183428135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.655|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.655
91773420|NCT00286442|183428135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.645|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.645
91773421|NCT00286442|183428136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.748|TWO_SIDED|95.0|-6.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-6.3|0.748
91773422|NCT00286442|183428136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.432|TWO_SIDED|95.0|-7.7|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.7|0.432
91773423|NCT00286442|183428137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.427|TWO_SIDED|95.0|-7.8|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.8|0.427
91773424|NCT00286442|183428137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.746|TWO_SIDED|95.0|-4.6|6.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.5|-4.6|0.746
91519975|NCT05120115|182914043|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
91707885|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0062|STANDARD_ERROR_OF_MEAN|0.0495|||TWO_SIDED|90.0|-0.0827|0.0952|||Mixed Models Analysis|||Day 14, Hour 4||0.0952|-0.0827|
91773425|NCT00286442|183428138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0|-5.0|7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.2|-5.0|0.727
91519976|NCT05120115|182914044|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
91773426|NCT00286442|183428138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601||||1.6|TWO_SIDED|95.0|-4.5|7.8||No multiplicity adjustments|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-4.5|1.6
91773427|NCT00286442|183428139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19||||0.066|TWO_SIDED|95.0|-0.15|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-0.15|0.066
91773428|NCT00286442|183428139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.18|TWO_SIDED|95.0|-0.74|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-0.74|0.180
91773429|NCT00286442|183428140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.944|TWO_SIDED|95.0|-5.02|4.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.68|-5.02|0.944
91773430|NCT00286442|183428140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.316|TWO_SIDED|95.0|-7.4|2.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.40|-7.40|0.316
91773431|NCT00286442|183428141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.901|TWO_SIDED|95.0|-5.42|4.77||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.77|-5.42|0.901
91773432|NCT00286442|183428141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.578|TWO_SIDED|95.0|-6.59|3.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.68|-6.59|0.578
91773433|NCT00286442|183428142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.708|TWO_SIDED|95.0|-2.67|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-2.67|0.708
91773434|NCT00286442|183428142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.601|TWO_SIDED|95.0|-2.44|4.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.21|-2.44|0.601
91773435|NCT00286442|183428143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.398|TWO_SIDED|95.0|-1.48|3.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.72|-1.48|0.398
91773436|NCT00286442|183428143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.425|TWO_SIDED|95.0|-1.56|3.69||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.69|-1.56|0.425
91773437|NCT00286442|183428144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87||||0.018|TWO_SIDED|95.0|0.5|5.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.23|0.50|0.018
91773438|NCT00286442|183428144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.067|TWO_SIDED|95.0|-0.15|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.60|-0.15|0.067
91773439|NCT00286442|183428145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.011|TWO_SIDED|95.0|-0.064|-0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.009|-0.064|0.011
91773440|NCT00286442|183428145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|||<|0.001|TWO_SIDED|95.0|-0.075|-0.019||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.075|<0.001
91773441|NCT00286442|183428146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||<|0.001|TWO_SIDED|95.0|-0.07|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.070|<0.001
91707886|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0124|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.0672|0.0919|||Mixed Models Analysis|||Day 14, Hour 8||0.0919|-0.0672|
91773442|NCT00286442|183428146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.004|TWO_SIDED|95.0|-0.062|-0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.062|0.004
91773443|NCT00286442|183428147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.007|TWO_SIDED|95.0|-0.068|-0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.011|-0.068|0.007
91773444|NCT00286442|183428147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.011|TWO_SIDED|95.0|-0.066|-0.008||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.008|-0.066|0.011
91773445|NCT00286442|183428148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|||<|0.001|TWO_SIDED|95.0|-0.08|-0.024||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.080|<0.001
91773446|NCT00286442|183428148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.003|TWO_SIDED|95.0|-0.072|-0.015||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.015|-0.072|0.003
91773447|NCT00286442|183428149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.078|TWO_SIDED|95.0|-0.097|0.005||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.005|-0.097|0.078
91773448|NCT00286442|183428149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.86|TWO_SIDED|95.0|-0.056|0.047||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.047|-0.056|0.860
91773449|NCT00286442|183428150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053||||0.048|TWO_SIDED|95.0|-0.106|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.106|0.048
91773450|NCT00286442|183428150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.889|TWO_SIDED|95.0|-0.057|0.05||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.050|-0.057|0.889
91646092|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8208|TWO_SIDED|95.0|0.69|1.6|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.60|0.69|0.8208
91773451|NCT00286442|183428151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.336||||0.031|TWO_SIDED|95.0|0.03|0.642||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.642|0.030|0.031
91773452|NCT00286442|183428151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304||||0.051|TWO_SIDED|95.0|-0.002|0.611||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.611|-0.002|0.051
91773453|NCT00286442|183428152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.563|TWO_SIDED|95.0|-0.209|0.384||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.384|-0.209|0.563
91773454|NCT00286442|183428152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.467|TWO_SIDED|95.0|-0.188|0.41||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.410|-0.188|0.467
91773455|NCT00286442|183428153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.243|TWO_SIDED|95.0|-0.127|0.501||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.501|-0.127|0.243
91519977|NCT03871595|182914045|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.51|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.36|103.83|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||103.83|95.36|
91773456|NCT00286442|183428153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279||||0.083|TWO_SIDED|95.0|-0.037|0.595||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.595|-0.037|0.083
91773457|NCT00286442|183428154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155||||0.321|TWO_SIDED|95.0|-0.152|0.463||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.463|-0.152|0.321
91773458|NCT00286442|183428154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.089|TWO_SIDED|95.0|-0.041|0.577||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.577|-0.041|0.089
91773459|NCT00286442|183428155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144||||0.305|TWO_SIDED|95.0|-0.132|0.42||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.420|-0.132|0.305
91773460|NCT00286442|183428155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191||||0.177|TWO_SIDED|95.0|-0.086|0.468||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.468|-0.086|0.177
91773461|NCT00286442|183428156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394||||0.007|TWO_SIDED|95.0|0.107|0.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.680|0.107|0.007
91773462|NCT00286442|183428156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263||||0.074|TWO_SIDED|95.0|-0.025|0.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.550|-0.025|0.074
91773463|NCT00286442|183428157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.117|17.864||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||17.864|2.117|<0.001
91773464|NCT00286442|183428157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.322||||0.002|TWO_SIDED|95.0|1.82|15.564||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||15.564|1.820|0.002
91773465|NCT00286442|183428158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.092|||<|0.001|TWO_SIDED|95.0|3.271|11.345||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||11.345|3.271|<0.001
91773466|NCT00286442|183428158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.451|||<|0.001|TWO_SIDED|95.0|2.388|8.296||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.296|2.388|<0.001
91773467|NCT00286442|183428159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.238|||<|0.001|TWO_SIDED|95.0|2.327|7.717||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.717|2.327|<0.001
91773468|NCT00286442|183428159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.293|||<|0.001|TWO_SIDED|95.0|1.814|5.979|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.979|1.814|<0.001
91773469|NCT00286442|183428160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.103|||<|0.001|TWO_SIDED|95.0|2.428|6.934||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.934|2.428|<0.001
91773470|NCT00286442|183428160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.314|||<|0.001|TWO_SIDED|95.0|2.545|7.312||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.312|2.545|<0.001
91773471|NCT00286442|183428161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.601|||<|0.001|TWO_SIDED|95.0|2.554|12.282||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.282|2.554|<0.001
91646093|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0562|TWO_SIDED|95.0|0.99|1.62|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||1.62|0.99|0.0562
91773472|NCT00286442|183428161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.793|||<|0.001|TWO_SIDED|95.0|2.645|12.684||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.684|2.645|<0.001
91773473|NCT00286442|183428162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.449||||0.085|TWO_SIDED|95.0|0.883|6.797||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.797|0.883|0.085
91773474|NCT00286442|183428162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958||||0.034|TWO_SIDED|95.0|1.087|8.046||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.046|1.087|0.034
91773475|NCT00286442|183428163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.404||||0.639|TWO_SIDED|95.0|0.34|5.803||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.803|0.340|0.639
91773476|NCT00286442|183428163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.956|TWO_SIDED|95.0|0.218|4.223||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||4.223|0.218|0.956
91773477|NCT00286442|183428164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.439|TWO_SIDED|95.0|-0.63|0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.27|-0.63|0.439
91773478|NCT00286442|183428164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.075|TWO_SIDED|95.0|-0.86|0.04||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.04|-0.86|0.075
91773479|NCT00286442|183428165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.305|TWO_SIDED|95.0|-0.26|0.83||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.83|-0.26|0.305
91773480|NCT00286442|183428165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.788|TWO_SIDED|95.0|-0.63|0.47||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.47|-0.63|0.788
91773481|NCT00286442|183428166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.93|TWO_SIDED|95.0|-0.58|0.63||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.63|-0.58|0.930
91773482|NCT00286442|183428166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.559|TWO_SIDED|95.0|-0.79|0.43||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.43|-0.79|0.559
91773483|NCT00286442|183428167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.66|0.66||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.66|-0.66|0.996
91773484|NCT00286442|183428167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.407|TWO_SIDED|95.0|-0.94|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.38|-0.94|0.407
91773485|NCT02174731|183428177|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% confidence interval (CI) of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|0.01|0.18|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean changes.|||0.18|0.01|<0.001
91773486|NCT02174731|183428178|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|95.0|0.03|0.25|||MMRM||Difference between groups (roxadustat minus Epoetin alfa) in LS mean change.|||0.25|0.03|<0.001
91519978|NCT03871595|182914046|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|70.11|STANDARD_DEVIATION|16.8|||TWO_SIDED|90.0|62.67|78.44|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||78.44|62.67|
91707887|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0186|STANDARD_ERROR_OF_MEAN|0.0408|||TWO_SIDED|90.0|-0.0918|0.0547|||Mixed Models Analysis|||Day 14, Hour 12||0.0547|-0.0918|
91773487|NCT02174731|183428179|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.0|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|0.00|<0.001
91773488|NCT02174731|183428180|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.014|<|0.001|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|-0.01|<0.001
91773489|NCT02174731|183428181|SUPERIORITY|Superiority was also declared as the lower bound of the 95% CI exceeded 0 and p-value was lower than 0.05.|Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.39|-0.27|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||-0.27|-0.39|<0.001
91773490|NCT02174731|183428182|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|0.04|0.36|||ANCOVA|MAR-based multiple imputation.|Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.36|0.04|<0.001
91773491|NCT02174731|183428183|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
91773492|NCT02174731|183428184|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the upper bound of the HR 95% CI of the difference between roxadustat and epoetin alfa was less than or equal to 1.8. Non-inferiority p-value is 1-sided. The CIs were from Wald and ties were calculated using the Efron method.|Hazard Ratio (HR)|0.83|||<|0.001|TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|||||1.07|0.64|<0.001
91773493|NCT00079040|183428187|SUPERIORITY_OR_OTHER||Percentage|63.5|||||TWO_SIDED|90.0|52.4|73.6||||||||73.6|52.4|
91773494|NCT00867165|183428294|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.74|||<|0.001|TWO_SIDED|95.0|-30.8|-22.69|||ANCOVA|||||-22.69|-30.80|<0.001
91773495|NCT00867165|183428295|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.92|||<|0.001|TWO_SIDED|95.0|-24.2|-17.65|||ANCOVA|||||-17.65|-24.20|<0.001
91773496|NCT00867165|183428296|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.24|||<|0.001|TWO_SIDED|95.0|-24.02|-16.45|||ANCOVA|||||-16.45|-24.02|<0.001
91773497|NCT00867165|183428297|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.807|TWO_SIDED|95.0|-4.97|6.36|||ANCOVA|||||6.36|-4.97|0.807
91773498|NCT00867165|183428298|SUPERIORITY_OR_OTHER_LEGACY||Differrence in least-squares means|-25.75|||<|0.001|TWO_SIDED|95.0|-29.59|-21.91|||ANCOVA|||||-21.91|-29.59|<0.001
91773499|NCT00867165|183428299|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-14.68||||0.021|TWO_SIDED|95.0|-27.35|-2.0|||Constrained longitudinal data analysis|||||-2.00|-27.35|0.021
91773500|NCT00867165|183428300|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.97|||<|0.001|TWO_SIDED|95.0|-28.95|-20.99|||ANCOVA|||||-20.99|-28.95|<0.001
91773501|NCT00867165|183428301|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-23.94|||<|0.001|TWO_SIDED|95.0|-27.49|-20.39|||ANCOVA|||||-20.39|-27.49|<0.001
91773502|NCT00867165|183428302|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-27.71|||<|0.001|TWO_SIDED|95.0|-31.7|-23.73|||ANCOVA|||||-23.73|-31.70|<0.001
91773503|NCT00867165|183428303|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.09|||<|0.001|TWO_SIDED|95.0|-23.3|-16.89|||ANCOVA|||||-16.89|-23.30|<0.001
91773504|NCT00867165|183428304|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.27|||<|0.001|TWO_SIDED|95.0|-23.39|-17.15|||ANCOVA|||||-17.15|-23.39|<0.001
91773505|NCT00867165|183428305|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-21.37|||<|0.001|TWO_SIDED|95.0|-24.67|-18.08|||ANCOVA|||||-18.08|-24.67|<0.001
91773506|NCT00867165|183428306|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-0.95||||0.733|TWO_SIDED|95.0|-6.46|4.55|||ANCOVA|||||4.55|-6.46|0.733
91773507|NCT00867165|183428307|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.53||||0.863|TWO_SIDED|95.0|-5.59|6.66|||ANCOVA|||||6.66|-5.59|0.863
91773508|NCT00867165|183428308|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.92||||0.501|TWO_SIDED|95.0|-3.71|7.56|||ANCOVA|||||7.56|-3.71|0.501
91773509|NCT00867165|183428309|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.18|||<|0.001|TWO_SIDED|95.0|-27.78|-20.58|||ANCOVA|||||-20.58|-27.78|<0.001
91773510|NCT00867165|183428310|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.61|||<|0.001|TWO_SIDED|95.0|-28.06|-21.16|||ANCOVA|||||-21.16|-28.06|<0.001
91773511|NCT00867165|183428311|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.55|||<|0.001|TWO_SIDED|95.0|-30.35|-22.75|||ANCOVA|||||-22.75|-30.35|<0.001
91773512|NCT00867165|183428312|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-9.73||||0.137|TWO_SIDED|95.0|-22.73|3.27|||Constrained longitudinal data analysis|||||3.27|-22.73|0.137
91773513|NCT00867165|183428313|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-15.19||||0.005|TWO_SIDED|95.0|-26.05|-4.34|||Constrained longitudinal data analysis|||||-4.34|-26.05|0.005
91773514|NCT00867165|183428314|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-8.61||||0.149|TWO_SIDED|95.0|-20.44|3.23|||Constrained longitudinal data analysis|||||3.23|-20.44|0.149
91773515|NCT00867165|183428315|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-1.91||||0.373|TWO_SIDED|95.0|-6.15|2.32|||ANCOVA|||||2.32|-6.15|0.373
91773516|NCT00867165|183428316|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-19.76|||<|0.001|TWO_SIDED|95.0|-24.7|-14.82|||ANCOVA|||||-14.82|-24.70|<0.001
91773517|NCT00867165|183428317|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.83|||<|0.001|TWO_SIDED|95.0|-25.59|-16.07|||ANCOVA|||||-16.07|-25.59|<0.001
91773518|NCT00867165|183428318|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-23.48|||<|0.001|TWO_SIDED|95.0|-29.0|-17.97|||ANCOVA|||||-17.97|-29.00|<0.001
91773519|NCT00867165|183428319|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-22.29|||<|0.001|TWO_SIDED|95.0|-27.25|-17.34|||ANCOVA|||||-17.34|-27.25|<0.001
91773520|NCT00867165|183428320|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.5|||<|0.001|TWO_SIDED|95.0|-29.88|-19.12|||ANCOVA|||||-19.12|-29.88|<0.001
91773521|NCT00867165|183428321|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-30.69|-19.62|||ANCOVA|||||-19.62|-30.69|<0.001
91773522|NCT00867165|183428322|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-29.31|||<|0.001|TWO_SIDED|95.0|-35.71|-22.91|||ANCOVA|||||-22.91|-35.71|<0.001
91773523|NCT00867165|183428323|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.35|||<|0.001|TWO_SIDED|95.0|-34.41|-22.29|||ANCOVA|||||-22.29|-34.41|<0.001
91773524|NCT00867165|183428324|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-19.28|||<|0.001|TWO_SIDED|95.0|-23.87|-14.7|||ANCOVA|||||-14.70|-23.87|<0.001
91773525|NCT00867165|183428325|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-46.11||||0.116|TWO_SIDED|95.0|-108.14|15.92|||Constrained longitudinal data analysis|||||15.92|-108.14|0.116
91707888|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0413|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|-0.1192|0.0365|||Mixed Models Analysis|||Day 14, Hour 24||0.0365|-0.1192|
91773526|NCT00867165|183428326|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|17.27||||0.382|TWO_SIDED|95.0|-20.46|55.0|||Constrained longitudinal data analysis|||||55.00|-20.46|0.382
91773527|NCT00867165|183428327|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.61|||<|0.001|TWO_SIDED|95.0|-55.36|-43.87|||ANCOVA|||||-43.87|-55.36|<0.001
91773528|NCT00867165|183428328|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-58.52|||<|0.001|TWO_SIDED|95.0|-63.67|-53.38|||ANCOVA|||||-53.38|-63.67|<0.001
91773529|NCT00867165|183428329|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-61.02|||<|0.001|TWO_SIDED|95.0|-67.51|-54.53|||ANCOVA|||||-54.53|-67.51|<0.001
91773530|NCT00867165|183428330|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.74||||0.001|TWO_SIDED|95.0|-73.22|-52.26|||ANCOVA|||||-52.26|-73.22|0.001
91773531|NCT00867165|183428331|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.48|||<|0.001|TWO_SIDED|95.0|-54.83|-44.14|||ANCOVA|||||-44.14|-54.83|<0.001
91773532|NCT00867165|183428332|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-57.99|||<|0.001|TWO_SIDED|95.0|-62.87|-53.11|||ANCOVA|||||-53.11|-62.87|<0.001
91773533|NCT00867165|183428333|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.6|||<|0.001|TWO_SIDED|95.0|-68.54|-56.66|||ANCOVA|||||-56.66|-68.54|<0.001
91773534|NCT00867165|183428334|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-64.67|||<|0.001|TWO_SIDED|95.0|-74.11|-55.23|||ANCOVA|||||-55.23|-74.11|<0.001
91773535|NCT00867165|183428335|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-18.35|||<|0.001|TWO_SIDED|95.0|-24.7|-11.99|||ANCOVA|||||-11.99|-24.70|<0.001
91773536|NCT00867165|183428336|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.61|||<|0.001|TWO_SIDED|95.0|-31.2|-20.02|||ANCOVA|||||-20.02|-31.20|<0.001
91773537|NCT00867165|183428337|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.74|||<|0.001|TWO_SIDED|95.0|-34.89|-22.59|||ANCOVA|||||-22.59|-34.89|<0.001
91773538|NCT00867165|183428338|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-32.14|||<|0.001|TWO_SIDED|95.0|-40.38|-23.9|||ANCOVA|||||-23.90|-40.38|<0.001
91773539|NCT00867165|183428339|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|20.01||||0.001|TWO_SIDED|95.0|8.1|31.91|||ANCOVA|||||31.91|8.10|0.001
91773540|NCT00867165|183428340|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|26.29|||<|0.001|TWO_SIDED|95.0|13.99|38.58|||ANCOVA|||||38.58|13.99|<0.001
91773541|NCT00867165|183428341|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|36.7|||<|0.001|TWO_SIDED|95.0|24.12|49.28|||ANCOVA|||||49.28|24.12|<0.001
91773542|NCT00867165|183428342|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|24.05|||<|0.001|TWO_SIDED|95.0|10.43|37.67|||ANCOVA|||||37.67|10.43|<0.001
91773543|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.88|1.08|||ANOVA|||Anti-HPV 6||1.08|0.88|<0.001
91773544|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
91773545|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||ANOVA|||Anti-HPV 16||1.09|0.89|<0.001
91773546|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.12|||ANOVA|||Anti-HPV 18||1.12|0.88|<0.001
91773547|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.04|||<|0.001|TWO_SIDED|95.0|0.93|1.17|||ANOVA|||Anti-HPV 31||1.17|0.93|<0.001
91773548|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||ANOVA|||Anti-HPV 33||1.11|0.89|<0.001
91773549|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.1|||<|0.001|TWO_SIDED|95.0|0.97|1.25|||ANOVA|||Anti-HPV 45||1.25|0.97|<0.001
91773550|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 52||1.10|0.88|<0.001
91773551|NCT00988884|183428384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 58||1.10|0.88|<0.001
91773552|NCT00988884|183428385|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|3.8|||<|0.001|TWO_SIDED|97.5|-1.7|9.3|||Miettinen and Nurminen|||Serogroup A||9.3|-1.7|<0.001
91773553|NCT00988884|183428385|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-5.4|1.1|||Miettinen and Nurminen|||Serogroup C||1.1|-5.4|<0.001
91773554|NCT00988884|183428385|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|2.1|||<|0.001|TWO_SIDED|97.5|-1.8|6.1|||Miettinen and Nurminen|||Serogroup Y||6.1|-1.8|<0.001
91773555|NCT00988884|183428385|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-4.7|0.3|||Miettinen and Nurminen|||Serogroup W-135||0.3|-4.7|<0.001
91773556|NCT00988884|183428386|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|97.5|-0.8|0.9|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||0.9|-0.8|<0.001
91773557|NCT00988884|183428386|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|97.5|-1.2|0.7|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||0.7|-1.2|<0.001
91773558|NCT00988884|183428387|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.8||||0.003|TWO_SIDED|97.5|0.69|0.92|||ANOVA|||Anti-PT||0.92|0.69|0.003
91773559|NCT00988884|183428387|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.91|||<|0.001|TWO_SIDED|97.5|0.83|1.01|||ANOVA|||Anti-FHA||1.01|0.83|<0.001
91773560|NCT00988884|183428387|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|97.5|0.84|1.08|||ANOVA|||Anti-PRN||1.08|0.84|<0.001
91773561|NCT00988884|183428387|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.96|||<|0.001|TWO_SIDED|97.5|0.76|1.21|||ANOVA|||Anti-FIM 2/3||1.21|0.76|<0.001
91773562|NCT00988884|183428390|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.806|TWO_SIDED|95.0|-3.5|2.7|||Miettinen and Nurminen|||||2.7|-3.5|0.806
91773563|NCT04621448|183428394|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.048|TWO_SIDED|95.0|0.01|4.39|||Mixed Models Analysis||The mean difference estimate of 2.2 was confirmed. It is slightly different than the difference of the raw change values \[+.7 - (-1.7) = 2.4\] because it comes from the mixed effects model.|||4.39|0.01|0.048
91773564|NCT04621448|183428395|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.603|TWO_SIDED|95.0|-4.12|2.4|||Mixed Models Analysis|||||2.40|-4.12|0.603
91773565|NCT04621448|183428396|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.734|TWO_SIDED|95.0|-2.75|3.92|||Mixed Models Analysis|||||3.92|-2.75|0.734
91773566|NCT04621448|183428397|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.159|TWO_SIDED|95.0|-0.62|3.74|||Mixed Models Analysis|||||3.74|-0.62|0.159
91773567|NCT04621448|183428398|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.818|TWO_SIDED|95.0|-1.97|1.56|||Mixed Models Analysis|||||1.56|-1.97|0.818
91773568|NCT04621448|183428399|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.089|TWO_SIDED|95.0|-0.26|3.51|||Mixed Models Analysis|||||3.51|-0.26|0.089
91773569|NCT04621448|183428400|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.631|TWO_SIDED|95.0|-0.96|1.58|||Mixed Models Analysis|||||1.58|-0.96|0.631
91773570|NCT04621448|183428401|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.484|TWO_SIDED|95.0|-0.71|1.49|||Mixed Models Analysis|||||1.49|-0.71|0.484
91773571|NCT04621448|183428402|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.81|TWO_SIDED|95.0|-2.36|3.01|||Mixed Models Analysis|||||3.01|-2.36|0.81
91773572|NCT04621448|183428403|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.384|TWO_SIDED|95.0|-0.77|2.0|||Mixed Models Analysis|||||2.00|-0.77|0.384
91773573|NCT04621448|183428404|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.509|TWO_SIDED|95.0|-1.65|0.81|||Mixed Models Analysis|||||0.81|-1.65|0.509
91773574|NCT04621448|183428405|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.021|TWO_SIDED|95.0|0.24|3.01|||Mixed Models Analysis|||||3.01|0.24|0.021
91773575|NCT04621448|183428406|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.156|TWO_SIDED|95.0|-1.94|0.31|||Mixed Models Analysis|||||0.31|-1.94|0.156
91773576|NCT04621448|183428407|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.582|TWO_SIDED|95.0|-0.62|1.1|||Mixed Models Analysis|||||1.10|-0.62|0.582
91773577|NCT04621448|183428408|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.271|TWO_SIDED|95.0|-1.21|0.34|||Mixed Models Analysis|||||0.34|-1.21|0.271
91773578|NCT04621448|183428409|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.834|TWO_SIDED|95.0|-1.52|1.88|||Mixed Models Analysis|||||1.88|-1.52|0.834
91773579|NCT04621448|183428410|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.529|TWO_SIDED|95.0|-1.62|3.15|||Mixed Models Analysis|||||3.15|-1.62|0.529
91773580|NCT04621448|183428411|SUPERIORITY|||||||0.377|||||||Poisson regression|||||||0.377
91773581|NCT04621448|183428412|SUPERIORITY|||||||0.043|||||||Poisson regression|||||||0.043
91773582|NCT00549640|183428413|SUPERIORITY_OR_OTHER|||||||0.973||95.0|||||Fisher Exact|1-tailed||||||0.973
91773583|NCT00549640|183428414|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|1 tailed test||||||0.500
91773584|NCT00549640|183428415|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline||||||0.65
91773585|NCT00549640|183428415|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|analysis performed using daily scores||||||0.79
91773586|NCT03550378|183428416|SUPERIORITY||LS Mean Difference|-30.384|||<|0.001|TWO_SIDED|90.0|-41.27|-19.498|||ANCOVA|||||-19.498|-41.270|<0.001
91773587|NCT04999839|183428451|SUPERIORITY||Odds Ratio (OR)|3.727|||=|0.052|TWO_SIDED|95.0|0.933|14.885||P-value was calculated using a Cochran-Mantel-Haenszel (CMH) test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the Mantel-Haenszel (MH) method.|||14.885|0.933|=0.052
91773588|NCT04999839|183428451|SUPERIORITY||Odds Ratio (OR)|12.733|||<|0.001|TWO_SIDED|95.0|3.525|45.994||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||45.994|3.525|<0.001
91773589|NCT04999839|183428451|SUPERIORITY||Odds Ratio (OR)|29.014|||<|0.001|TWO_SIDED|95.0|8.526|98.735||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||98.735|8.526|<0.001
91773590|NCT04999839|183428451|SUPERIORITY||Odds Ratio (OR)|40.111|||<|0.001|TWO_SIDED|95.0|10.277|156.548||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||156.548|10.277|<0.001
91773591|NCT03546621|183428475|SUPERIORITY||||||<|0.0001|||||||Bonferroni-Holm|||For each of the three Myrcludex B treatment groups, a null hypothesis of no clinically significant difference in proportion of responders compared to the control group (Tenofovir only), at week 24, were tested using the one-sided Wald test for superiority, at a one-sided overall significance level of 0.05 adjusted for multiple testing according to Bonferroni-Holm, with the superiority limit (test margin) set to 5%.||||<.0001
91773592|NCT03546621|183428476|SUPERIORITY|||||||0.9818||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.9818
91773593|NCT03546621|183428476|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value as smaller than 0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||1.0000
91773594|NCT03546621|183428476|SUPERIORITY|||||||0.7132||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.7132
91773595|NCT03546621|183428477|SUPERIORITY|||||||0.0232||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.~This analysis, and presentation of descriptive statistics, was repeated for the subgroups of patients with normal/abnormal baseline ALT values."||||0.0232
91773596|NCT03546621|183428477|SUPERIORITY|||||||0.0047||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0047
91773597|NCT03546621|183428477|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0010
91773598|NCT03546621|183428478|SUPERIORITY|||||||0.1642||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to week 24 and week 48 in ALT levels was performed using van Elteren tests.~Fisher's exact test was used to test a null hypothesis of no difference in proportions (of patients with normal ALT values) against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.1642
91773599|NCT03546621|183428478|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
91773600|NCT03546621|183428478|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
91773601|NCT03546621|183428478|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Boferroni-Holm|||Week 48||||0.2388
91773602|NCT03546621|183428478|SUPERIORITY|||||||0.7157||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.7157
91773603|NCT03546621|183428478|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.2388
91773604|NCT03546621|183428479|SUPERIORITY|||||||0.7416||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.7416
91773605|NCT03546621|183428479|SUPERIORITY|||||||0.4434||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.4434
91773606|NCT03546621|183428479|SUPERIORITY|||||||0.7371||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24.||||0.7371
91773607|NCT03546621|183428479|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91773608|NCT03546621|183428479|SUPERIORITY|||||||0.9441||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.9441
91773609|NCT03546621|183428479|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91646094|NCT01236053|183184662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2596|TWO_SIDED|95.0|0.9|1.47|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.47|0.90|0.2596
91707889|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4011|STANDARD_ERROR_OF_MEAN|0.3916|||TWO_SIDED|90.0|-0.2968|1.099|||Mixed Models Analysis|||Follow-up, Day 25-29||1.0990|-0.2968|
91646095|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0709|TWO_SIDED|95.0|0.99|1.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.28|0.99|0.0709
91646096|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.4996|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.4996
91773610|NCT03546621|183428480|SUPERIORITY||Bonferroni-Holm|||||0.5984||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to Week 24 in HBsAg was performed using van Elteren tests. Tests were performed on log-10 transformed data.~Separare comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted values were computed using the Bonferroni-Holm method."||||0.5984
91773611|NCT03546621|183428480|SUPERIORITY|||||||0.7529||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.7529
91773612|NCT03546621|183428480|SUPERIORITY|||||||0.3305||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.3305
91773613|NCT03546621|183428480|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91773614|NCT03546621|183428480|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91773615|NCT03546621|183428480|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91773616|NCT03546621|183428481|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Tests were performed on log-10 transformed data. Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||1.0000
91773617|NCT03546621|183428481|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24.||||1.0000
91773618|NCT03546621|183428481|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24||||1.0000
91773619|NCT03546621|183428481|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 48||||1.0000
91773620|NCT03546621|183428481|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91707890|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1175|STANDARD_ERROR_OF_MEAN|0.0537|||TWO_SIDED|90.0|0.0223|0.2127|||Mixed Models Analysis|||Day 1, Hour 1||0.2127|0.0223|
91707891|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3845|STANDARD_ERROR_OF_MEAN|0.0802|||TWO_SIDED|90.0|0.2424|0.5266|||Mixed Models Analysis|||Day 1, Hour 2||0.5266|0.2424|
91773621|NCT03546621|183428481|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
91773622|NCT00660192|183428484|SUPERIORITY_OR_OTHER|||||||0.0347|TWO_SIDED||||||t-test, 2 sided|||||||0.0347
91773623|NCT00660192|183428485|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.0300
91707892|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3812|STANDARD_ERROR_OF_MEAN|0.0536|||TWO_SIDED|90.0|0.2862|0.4762|||Mixed Models Analysis|||Day 1, Hour 4||0.4762|0.2862|
91773624|NCT01069484|183428498|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of \<0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.|Risk Ratio (RR)|0.89||||0.57|TWO_SIDED|95.0|0.6|1.32||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.32|0.60|0.57
91773625|NCT01069484|183428499|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.51|TWO_SIDED|95.0|0.49|1.42||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.42|0.49|0.51
91773626|NCT02732600|183428522|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.59||0.39|TWO_SIDED|95.0|-0.66|1.68|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||1.68|-0.66|0.39
91773627|NCT02732600|183428522|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.71||0.35|TWO_SIDED|95.0|-0.75|2.06|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.06|-0.75|0.35
91773628|NCT02732600|183428522|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.81||0.21|TWO_SIDED|95.0|-0.57|2.6|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.60|-0.57|0.21
91773629|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.6||0.156|TWO_SIDED|95.0|-2.2|13.48|||t-test, 2 sided|||t-test used to compare group differences in Cohesiveness at BASELINE||13.48|-2.2|0.156
91773630|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|7.97|STANDARD_ERROR_OF_MEAN|5.89||0.182|TWO_SIDED|95.0|-3.85|19.8|||t-test, 2 sided|||t-test to compare group means on Communication at BASELINE||19.8|-3.85|0.182
91773631|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|8.41|STANDARD_ERROR_OF_MEAN|6.31||0.234|TWO_SIDED|95.0|-5.74|22.57|||t-test, 2 sided|||t-test to compare group differences on Role Clarity at BASELINE||22.57|-5.74|0.234
91773632|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|14.14|STANDARD_ERROR_OF_MEAN|9.63||0.149|TWO_SIDED|95.0|-5.22|33.5|||t-test, 2 sided|||t-test to compare group values on Goals at Baseline||33.5|-5.22|0.149
91773633|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|7.1||0.947|TWO_SIDED|95.0|-14.7|13.8|||t-test, 2 sided|||t-test of differences between groups on Cohesiveness at 6-Months||13.8|-14.7|0.947
91773634|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|8.4||0.87|TWO_SIDED|95.0|-15.6|18.4|||t-test, 2 sided|||t-test of groups differences on Communication at 6 Months||18.4|-15.6|0.870
91773635|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|8.62||0.478|TWO_SIDED|95.0|-11.26|23.63|||t-test, 2 sided|||t-test of group differences on Role Clarity at 6 months||23.63|-11.26|0.478
91773636|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|7.71||0.773|TWO_SIDED|95.0|-13.35|17.83|||t-test, 2 sided|||t-test of group differences on Goals at 6 Months||17.83|-13.35|0.773
91773637|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|9.09|STANDARD_ERROR_OF_MEAN|9.8||0.498|TWO_SIDED|95.0|-20.4|38.6|||t-test, 2 sided|||t-test of group differences on Cohesiveness at 1year||38.6|-20.4|0.498
91773638|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|11.4||0.78|TWO_SIDED|95.0|-20.3|26.7|||t-test, 2 sided|||t-test of group differences on Communication at 1 year||26.7|-20.3|0.780
91773639|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|11.46|STANDARD_ERROR_OF_MEAN|12.54||0.474|TWO_SIDED|95.0|-23.19|46.11|||t-test, 2 sided|||t-test of group differences on Role Clarity at 1 year||46.11|-23.19|0.474
91773640|NCT02732600|183428523|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.78||0.267|TWO_SIDED|95.0|-8.21|28.21|||t-test, 2 sided|||t-test of group differences on Goals at 1 year||28.21|-8.21|0.267
91773641|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.38||0.098|TWO_SIDED|95.0|-0.09|1.0|||t-test, 2 sided|||t test comparison across groups on CORE PEER at 6 months||1.00|-0.09|0.098
91773642|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.282|TWO_SIDED|95.0|-0.43|1.43|||t-test, 2 sided|||t-test comparison across groups on COLLABORATION at 6 months||1.43|-0.43|0.282
91773643|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.56||0.06|TWO_SIDED|95.0|-0.05|2.29|||t-test, 2 sided|||t-test comparison across groups on PEER SPECIALIST AS LIAISON at 6 months||2.29|-0.05|0.06
91773644|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.86||0.34|TWO_SIDED|95.0|0.07|1.59|||t-test, 2 sided|||t-test comparison across groups on PROVIDES INFO ON SERVICES at 6 months||1.59|0.07|0.34
91773645|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.34|TWO_SIDED|95.0|-0.94|2.62|||t-test, 2 sided|||t-test comparison across groups on Symptoms and Medication at 6-months||2.62|-0.94|0.34
91773646|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.64||0.66|TWO_SIDED|95.0|-1.03|1.5|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 6-months||1.50|-1.03|0.66
91773647|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.61||0.15|TWO_SIDED|95.0|-0.36|2.16|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 6 Months||2.16|-0.36|0.15
91773648|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.39||0.59|TWO_SIDED|95.0|-1.01|0.59|||t-test, 2 sided|||t-test comparison across groups on Leadership at 6-months||0.59|-1.01|0.59
91773649|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.84||0.95|TWO_SIDED|95.0|-1.77|1.68|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 6 months||1.68|-1.77|0.95
91773650|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.55||0.32|TWO_SIDED|95.0|-0.58|1.68|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 6 months||1.68|-0.58|0.32
91773651|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.64||0.27|TWO_SIDED|95.0|-0.6|2.04|||t-test, 2 sided|||t-test comparison across both groups on Resources at 6 months||2.04|-0.60|0.27
91773652|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.86||0.93|TWO_SIDED|95.0|-1.71|1.85|||t-test, 2 sided|||t-test comparison across groups on Performance Reviews at 6 months||1.85|-1.71|0.93
91773653|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.32||0.15|TWO_SIDED|95.0|-1.45|-0.005|||t-test, 2 sided|||t-test comparison across groups on CORE PEER at 1 year||-0.005|-1.45|0.15
91773654|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.45||0.04|TWO_SIDED|95.0|-1.7|0.32|||t-test, 2 sided|||t-test comparison across groups on Collaboration at 1 year||0.32|-1.7|0.04
91646097|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||<|0.0001|TWO_SIDED|95.0|1.23|1.45|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.45|1.23|<0.0001
91646098|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||<|0.0001|TWO_SIDED|95.0|1.14|1.35|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.35|1.14|<0.0001
91646099|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0062|TWO_SIDED|95.0|1.05|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.36|1.05|0.0062
91773655|NCT02732600|183428524|SUPERIORITY||Hazard Ratio, log|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-2.07|0.17|||t-test, 2 sided|||t-test comparison across groups on Peer Specialists as Liaison at 1 year||0.17|-2.07|0.08
91773656|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.26|TWO_SIDED|95.0|-0.58|0.18|||t-test, 2 sided|||t-test comparison across groups on Provides Info on Services at 1 year||0.18|-0.58|0.26
91773657|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.65||0.61|TWO_SIDED|95.0|-4.53|2.83|||t-test, 2 sided|||t-test comparison between groups on Symptoms and Medication at 1 year||2.83|-4.53|0.61
91773658|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.87||0.3|TWO_SIDED|95.0|-2.87|1.01|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 1 year||1.01|-2.87|0.30
91773659|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|-2.08|-0.52|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 1 year||-0.52|-2.08|0.004
91773660|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.01|TWO_SIDED|95.0|-4.2|-0.6|||t-test, 2 sided|||t-test comparison across groups on Leadership at 1 year||-0.60|-4.20|0.01
91773661|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.9|TWO_SIDED|95.0|-24.1|23.5|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 1 year||23.5|-24.1|0.90
91773662|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.7||0.06|TWO_SIDED|95.0|-3.02|0.12|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 1 year||0.12|-3.02|0.06
91773663|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.71|TWO_SIDED|95.0|-0.97|1.37|||t-test, 2 sided|||t-test comparison across groups on Resources at 1 year||1.37|-0.97|0.71
91773664|NCT02732600|183428524|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.63||0.41|TWO_SIDED|95.0|-5.03|2.23|||t-test, 2 sided|||t-test comparison on Performance Reviews at 1 year||2.23|-5.03|0.41
91773665|NCT02732600|183428525|SUPERIORITY||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.17||0.002|TWO_SIDED|95.0|1.29|5.88||not adjusted for multiple comparisons|t-test, 2 sided|||Group Comparison at Baseline||5.88|1.29|0.002
91773666|NCT02732600|183428525|SUPERIORITY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|1.6||0.1|TWO_SIDED|95.0|-0.54|5.78|||t-test, 2 sided|||Group Comparison at 6 Months||5.78|-0.54|0.10
91613884|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.931||||0.0271|TWO_SIDED|95.0|1.077|3.461|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.461|1.077|0.0271
91773667|NCT02732600|183428525|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.83||0.77|TWO_SIDED|95.0|-3.06|4.14|||t-test, 2 sided|||Group Comparison at 1 year||4.14|-3.06|0.77
91773668|NCT02732600|183428526|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.56||0.02|TWO_SIDED|95.0|0.56|6.38||p value for 1st year only|t-test, 2 sided|||||6.38|0.56|0.02
91773669|NCT02732600|183428526|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|2.39||0.93|TWO_SIDED|95.0|-4.67|5.04|||t-test, 2 sided|||||5.04|-4.67|0.93
91773670|NCT02732600|183428527|SUPERIORITY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|p value for 1st year||||1.37|0.68|0.0001
91773671|NCT02732600|183428528|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.26||0.02|TWO_SIDED|95.0|1.46|9.96|||t-test, 2 sided|||||9.96|1.46|0.02
91773672|NCT02732600|183428528|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.92||0.38|TWO_SIDED|95.0|-3.14|8.54|||t-test, 2 sided|||||8.54|-3.14|0.38
91773673|NCT02732600|183428529|SUPERIORITY||Mean Difference (Final Values)|-99.4|STANDARD_ERROR_OF_MEAN|41.73||0.027|TWO_SIDED|95.0|-186.2|-12.66|||t-test, 2 sided|||||-12.66|-186.2|0.027
91773674|NCT02732600|183428530|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|0.28|0.92|||t-test, 2 sided|||||0.92|0.28|0.001
91773675|NCT02051764|183428557|OTHER|||||||0.2837||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.2837
91773676|NCT02051764|183428557|OTHER|||||||0.9276||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.9276
91773677|NCT02051764|183428557|OTHER|||||||0.6324||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.6324
91773678|NCT00591006|183428558|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<0.01
91773679|NCT00591006|183428558|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||.12
91773680|NCT00591006|183428558|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||.15
91773681|NCT00591006|183428558|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||.10
91773682|NCT00591006|183428559|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
91773683|NCT00591006|183428559|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
91773684|NCT00591006|183428559|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
91773685|NCT00591006|183428559|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||.02
91773686|NCT00591006|183428560|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
91773687|NCT00591006|183428560|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
91773688|NCT00591006|183428560|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||.11
91773689|NCT00591006|183428560|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
91773690|NCT02898454|183428561|SUPERIORITY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.71|||ANCOVA|||Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.03|<0.0001
91773691|NCT02898454|183428562|SUPERIORITY||LS mean difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.51|||ANCOVA|||Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.51|-2.10|<0.0001
91773692|NCT02898454|183428563|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.|LS mean difference|-5.13|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.46||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-4.46|-5.80|<0.0001
91773693|NCT02898454|183428564|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.44|||<|0.0001|TWO_SIDED|95.0|-2.87|-2.02||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.02|-2.87|<0.0001
91773694|NCT02898454|183428565|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.52|||<|0.0001|TWO_SIDED|95.0|8.98|12.07||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.07|8.98|<0.0001
91773695|NCT02898454|183428566|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.81||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.81|-1.15|<0.0001
91773696|NCT02898454|183428567|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-17.36|||<|0.0001|TWO_SIDED|95.0|-20.87|-13.85||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-13.85|-20.87|<0.0001
91773697|NCT02898454|183428568|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.59|-1.83||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.83|-2.59|<0.0001
91773698|NCT02898454|183428568|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.78|-2.03||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.03|-2.78|<0.0001
91773699|NCT02898454|183428569|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.92||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.92|-1.30|<0.0001
91773700|NCT02898454|183428569|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.8||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.80|-1.18|<0.0001
91773701|NCT02898454|183428570|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.36|||<|0.0001|TWO_SIDED|95.0|-25.45|-17.27||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.27|-25.45|<0.0001
91773702|NCT02898454|183428570|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-20.73|||<|0.0001|TWO_SIDED|95.0|-24.81|-16.65||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-16.65|-24.81|<0.0001
91773703|NCT03040141|183428604|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.9||||0.181|TWO_SIDED|95.0|1.03|13.55|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||13.55|1.03|0.181
91773704|NCT03040141|183428604|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.3||||0.073|TWO_SIDED|95.0|0.9|12.13|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||12.13|0.90|0.073
91773705|NCT03040141|183428604|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.5||||0.037|TWO_SIDED|95.0|1.08|11.48|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||11.48|1.08|0.037
91773706|NCT03040141|183428604|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.1||||0.814|TWO_SIDED|95.0|0.4|3.25|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||3.25|0.40|0.814
91773707|NCT03040141|183428606|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.748||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level. The goal will be used to assess the strength of evidence to select the endpoints for a Phase 3 trial.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.748
91707893|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2841|STANDARD_ERROR_OF_MEAN|0.0563|||TWO_SIDED|90.0|0.1843|0.3838|||Mixed Models Analysis|||Day 1, Hour 8||0.3838|0.1843|
91773708|NCT03040141|183428606|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference||||0.940
91773709|NCT03040141|183428606|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.902||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The total VIS410 high-dose group (high-dose + low-dose) was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.902
91773710|NCT03040141|183428606|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.283||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.283
91773711|NCT03040141|183428607|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.919||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.919
91773712|NCT03040141|183428607|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.9||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.900
91773713|NCT03040141|183428607|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.99||||||p-value is not adjusted for multiple comparisons|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level||The combined VIS410 high- and low-dose groups was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.990
91773714|NCT03040141|183428607|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.521||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.521
91773715|NCT03040141|183428608|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|ANOVA|||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.360
91773716|NCT03040141|183428609|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
91773717|NCT03040141|183428609|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.259|||||||ANOVA|||||||0.259
91773718|NCT03040141|183428609|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.644||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.644
91773719|NCT03040141|183428609|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.146|||||||ANOVA|||||||0.146
91773720|NCT03040141|183428610|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.624||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.624
91773721|NCT03040141|183428610|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.399||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.399
91773722|NCT03040141|183428610|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.837|||||||ANOVA|||||||0.837
91773723|NCT03040141|183428610|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.183|||||||ANOVA|||||||0.183
91773724|NCT03040141|183428611|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.88|||||||ANOVA|||||||0.880
91773725|NCT03040141|183428611|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.778|||||||ANOVA|||||||0.778
91773726|NCT03040141|183428611|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94|||||||ANOVA|||||||0.940
91773727|NCT03040141|183428611|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.662|||||||ANOVA|||||||0.662
91646100|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1144|TWO_SIDED|95.0|0.98|1.26|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|0.98|0.1144
91773728|NCT03040141|183428612|OTHER|||||||0.64|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.640
91773729|NCT03040141|183428612|OTHER|||||||0.775|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.775
91773730|NCT03040141|183428612|OTHER|||||||0.701|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.701
91773731|NCT03040141|183428612|OTHER|||||||0.638|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.638
91773732|NCT03040141|183428613|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
91773733|NCT03040141|183428613|OTHER|||||||1|||||||Regression, Logistic|||||||1.000
91773734|NCT03040141|183428613|OTHER|||||||0.458|||||||Regression, Logistic|||||||0.458
91773735|NCT03040141|183428613|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
91773736|NCT03040141|183428614|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.371|||||||ANOVA|||||||0.371
91773737|NCT03040141|183428614|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
91707894|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1462|STANDARD_ERROR_OF_MEAN|0.0467|||TWO_SIDED|90.0|0.0635|0.2289|||Mixed Models Analysis|||Day 1, Hour 12||0.2289|0.0635|
91707895|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0702|||TWO_SIDED|90.0|0.0436|0.2924|||Mixed Models Analysis|||Day 1, Hour 24||0.2924|0.0436|
91707896|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1303|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.0172|0.2778|||Mixed Models Analysis|||Day 7, pre-dose||0.2778|-0.0172|
91646101|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||<|0.0001|TWO_SIDED|95.0|1.3|1.55|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.55|1.30|<0.0001
91773738|NCT03040141|183428614|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.476|||||||ANOVA|||||||0.476
91773739|NCT03040141|183428614|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.581|||||||ANOVA|||||||0.581
91773740|NCT03040141|183428615|OTHER|||||||0.98|||||||Regression, Logistic|||||||0.980
91773741|NCT03040141|183428615|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
91773742|NCT03040141|183428615|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
91773743|NCT03040141|183428615|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
91773744|NCT03040141|183428616|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.695|||||||ANOVA|||||||0.695
91773745|NCT03040141|183428616|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.542|||||||ANOVA|||||||0.542
91773746|NCT03040141|183428616|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.899|||||||ANOVA|||||||0.899
91773747|NCT03040141|183428616|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.321|||||||ANOVA|||||||0.321
91773748|NCT03040141|183428617|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.663|||||||ANOVA|||||||0.663
91773749|NCT03040141|183428617|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.54|||||||ANOVA|||||||0.540
91773750|NCT03040141|183428617|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.918|||||||ANOVA|||||||0.918
91773751|NCT03040141|183428617|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.294|||||||ANOVA|||||||0.294
91773752|NCT03040141|183428619|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.25|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.250
91773753|NCT03040141|183428619|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.133|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.133
91773754|NCT03040141|183428619|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.177|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.177
91773755|NCT03040141|183428619|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.360
91773756|NCT03040141|183428620|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.636|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.636
91773757|NCT03040141|183428620|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.446|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.446
91773758|NCT03040141|183428620|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.53|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.530
91773759|NCT03040141|183428620|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.463|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.463
91773760|NCT03040141|183428621|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.152|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.152
91773761|NCT03040141|183428621|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.176|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.176
91773762|NCT03040141|183428621|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.157|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.157
91773763|NCT03040141|183428621|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.844|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.844
91773764|NCT03040141|183428622|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.531|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.531
91773765|NCT03040141|183428622|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.582|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.582
91773766|NCT03040141|183428622|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.55|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.550
91773767|NCT03040141|183428622|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.84|||||||Chi-squared|P-value determined based on Cox proportional hazards model Wald Chi-Square Statistic.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.840
91773768|NCT03040141|183428623|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.3534|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.3534
91773769|NCT03040141|183428623|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7839|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7839
91707897|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1953|STANDARD_ERROR_OF_MEAN|0.0747||||90.0|0.0625|0.3281|||Mixed Models Analysis|||Day 7, Hour 1||0.3281|0.0625|
91773770|NCT03040141|183428623|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.4893|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.4893
91773771|NCT03040141|183428623|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5101|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5101
91773772|NCT03040141|183428624|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5436|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5436
91773773|NCT03040141|183428624|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.8215|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.8215
91773774|NCT03040141|183428624|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.6319|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.6319
91773775|NCT03040141|183428624|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7011|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7011
91773776|NCT03040141|183428625|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.478|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.478
91773777|NCT03040141|183428625|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.468|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.468
91773778|NCT03040141|183428625|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.412|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.412
91773779|NCT03040141|183428625|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.982|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.982
91773780|NCT03071263|183428663|SUPERIORITY||||||<|0.0001||||||α-level 0.05. Stratified by baseline potassium category (4.3-\<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized|Cochran-Mantel-Haenszel|||A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.||||<0.0001
91773781|NCT03071263|183428664|SUPERIORITY|||||||0.5757||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as factors in the model.|ANCOVA|||||||0.5757
91773782|NCT03071263|183428665|SUPERIORITY|||||||0.6367||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus as factors in the model.|ANCOVA|||The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.||||0.6367
91773783|NCT01650194|183428725|OTHER|||||||0.615|||||||t-test, 2 sided|||Testosterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.6150
91773784|NCT01650194|183428727|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773785|NCT01650194|183428728|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773786|NCT01650194|183428729|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Progesterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773787|NCT01650194|183428730|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773788|NCT01650194|183428731|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Testosterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773789|NCT01650194|183428733|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773790|NCT01650194|183428734|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773791|NCT01650194|183428735|OTHER|||||||0.0002|||||||t-test, 2 sided|||Progesterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.0002
91773792|NCT01650194|183428736|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
91773793|NCT01602224|183428760|SUPERIORITY||Odds Ratio (OR)|1.98||||0.401|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.401
91773794|NCT01602224|183428760|SUPERIORITY||Odds Ratio (OR)|1.84||||0.455|TWO_SIDED||||||Regression, Logistic|||300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.455
91773795|NCT01602224|183428760|SUPERIORITY||Odds Ratio (OR)|1.9||||0.419|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.||||0.419
91773796|NCT01352117|183428762|SUPERIORITY|||||||0.911||||||The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (\<200 vs. \>=200 cells/mm\^3).||||||0.911
91646102|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|||<|0.0001|TWO_SIDED|95.0|1.2|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.43|1.20|<0.0001
91773797|NCT03525444|183428794|SUPERIORITY||Least Squares (LS) Mean Difference|13.8|||<|0.0001|TWO_SIDED|95.0|12.1|15.4|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.4|12.1|<0.0001
91773798|NCT03525444|183428795|SUPERIORITY||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|12.7|15.8|||Mixed-effects model for repeated measure|||||15.8|12.7|<0.0001
91773799|NCT03525444|183428796|SUPERIORITY||Rate ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Negative binomial regression model|||||0.55|0.25|<0.0001
91773800|NCT03525444|183428797|SUPERIORITY||LS Mean Difference|-41.8|||<|0.0001|TWO_SIDED|95.0|-44.4|-39.3|||Mixed-effects model for repeated measure|||||-39.3|-44.4|<0.0001
91773801|NCT03525444|183428798|SUPERIORITY||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|17.5|23.0|||Mixed-effects model for repeated measure|||||23.0|17.5|<0.0001
91773802|NCT03525444|183428799|SUPERIORITY||LS Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.85|1.23|||Mixed-effects model for repeated measure|||||1.23|0.85|<0.0001
91773803|NCT03525444|183428800|SUPERIORITY||LS Mean Difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-44.0|-38.5|||Mixed-effects model for repeated measure|||||-38.5|-44.0|<0.0001
91773804|NCT03525444|183428801|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|16.9|23.2|||Mixed-effects model for repeated measure|||||23.2|16.9|<0.0001
91773805|NCT03525444|183428803|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|95.0|0.17|0.43||||||||0.43|0.17|
91773806|NCT03525444|183428804|SUPERIORITY||LS Mean Difference|2.9|||||TWO_SIDED|95.0|2.3|3.4||||||||3.4|2.3|
91773807|NCT01183689|183428859|SUPERIORITY||Mean Difference (Net)|0.82|STANDARD_ERROR_OF_MEAN|0.3|<|0.05|TWO_SIDED|95.0|0.23|1.41||No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.|Mixed Models Analysis||Above is provided the mean difference between Arms 1 and 2.|Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.||1.41|0.23|<0.05
91773808|NCT01183689|183428859|SUPERIORITY||Mean Difference (Net)|2.64|||<|0.05|TWO_SIDED|95.0|2.05|3.22|||Mixed Models Analysis|This was fitted with Proc Mixed in SAS.|95% confidence interval excludes 0|Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.||3.22|2.05|<0.05
91773809|NCT01183689|183428860|OTHER|Generalized Estimating Equations|Odds Ratio (OR)|1.41|||<|0.05|TWO_SIDED|95.0|1.02|1.9|||Generalized Estimating Equations|||Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.||1.90|1.02|<0.05
91773810|NCT01183689|183428860|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.05|TWO_SIDED|95.0|1.64|3.19|||generalized estimating equations|||This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,||3.19|1.64|<0.05
91773811|NCT01183689|183428861|SUPERIORITY||Mean Difference (Net)|1.31|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED|95.0|0.39|2.24|||Mixed Models Analysis|The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.|Listed above is the mean difference between arms 1 and 2|Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.||2.24|0.39|<0.05
91773812|NCT01183689|183428861|SUPERIORITY||Median Difference (Net)|2.04|||<|0.05|TWO_SIDED|95.0|1.11|2.98|||Mixed Models Analysis|A linear contrast was used to compare groups 1 and 3 at 24 months.||A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.||2.98|1.11|<0.05
91773813|NCT01183689|183428862|SUPERIORITY||Mean Difference (Net)|1.99||||0.13|TWO_SIDED|95.0|0.06|3.92||The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.|ANOVA|||Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.||3.92|0.06|0.13
91773814|NCT01183689|183428862|SUPERIORITY||Mean Difference (Net)|0.93||||0.13|TWO_SIDED|95.0|-0.98|2.84|||ANOVA|||Mean differences in systolic blood pressure between groups 1 and 3 over time.||2.84|-0.98|0.13
91773815|NCT01183689|183428863|SUPERIORITY||Mean Difference (Net)|1.73||||0.06|TWO_SIDED|95.0|0.32|3.14||The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.|ANOVA|||Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.||3.14|0.32|0.06
91773816|NCT01183689|183428863|SUPERIORITY||Mean Difference (Net)|0.92||||0.06|TWO_SIDED|95.0|-0.49|2.33||This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.||2.33|-0.49|0.06
91773817|NCT01183689|183428864|SUPERIORITY||Mean Difference (Net)|-1.3||||0.73|TWO_SIDED|95.0|-6.12|3.52||The p-value results from a 2 degree of freedom F-test.|ANOVA|||Mean changes from baseline to 2 years were compared between Groups 1 and 2.||3.52|-6.12|0.73
91773818|NCT01183689|183428864|SUPERIORITY||Mean Difference (Net)|-1.89||||0.73|TWO_SIDED|95.0|-4.36|0.58||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.||0.58|-4.36|0.73
91773819|NCT01183689|183428865|SUPERIORITY||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.23|4.52||The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.|generalized estimating equations|||The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.||4.52|1.23|<0.001
91773820|NCT01183689|183428865|SUPERIORITY||Odds Ratio (OR)|2.13||||0.008|TWO_SIDED|95.0|1.12|4.1||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|generalized estimating equations|||Generalized estimating equations were used. Differences were summarized with odds ratios.||4.10|1.12|0.008
91646103|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.0469|TWO_SIDED|95.0|1.0|1.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.29|1.00|0.0469
91519979|NCT03871595|182914047|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.78|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.64|104.11|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||104.11|95.64|
91773821|NCT01183689|183428866|SUPERIORITY||Mean Difference (Net)|-0.08||||0.002|TWO_SIDED|95.0|-0.61|0.45||the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups|ANOVA|the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups||Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test||0.45|-0.61|0.002
91773822|NCT01183689|183428866|SUPERIORITY||Mean Difference (Net)|0.55||||0.002|TWO_SIDED|95.0|0.02|1.08||This p-value is from a 2 degree of freedom test for differences among all 3 groups|ANOVA|||Differences among the 3 groups were based on analyses of variance.||1.08|0.02|0.002
91773823|NCT01183689|183428867|SUPERIORITY|A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.|Mean Difference (Net)|-0.85|||<|0.001|TWO_SIDED|95.0|-1.32|-0.38||The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.|ANOVA|The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.||Changes in units of the scale from baseline to 2 years||-0.38|-1.32|<0.001
91773824|NCT01183689|183428867|SUPERIORITY||Mean Difference (Net)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.57|0.37||This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||0.37|-0.57|<0.001
91773825|NCT01183689|183428868|SUPERIORITY|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|Mean Difference (Net)|0.2|||<|0.001|TWO_SIDED|95.0|-0.31|0.71||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints|ANOVA|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||0.71|-0.31|<0.001
91773826|NCT01183689|183428868|SUPERIORITY||Mean Difference (Net)|0.88||||0.002|TWO_SIDED|95.0|0.37|1.39||This p-value is from a 2 degree freedom test of differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.||1.39|0.37|0.002
91773827|NCT01183689|183428869|SUPERIORITY||Mean Difference (Net)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.71|0.45||2 degree of freedom F-test from analysis of variance|ANOVA|2 degree of freedom F-test from analysis of variance to compare mean differences among arms||2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline||0.45|-0.71|<0.001
91773828|NCT01183689|183428869|SUPERIORITY||Median Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|0.82|1.98||This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||1.98|0.82|<0.001
91773829|NCT01183689|183428870|SUPERIORITY||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.24|0.09||This p-value is from a 2 degree of freedom test for differences among the 3 arms.|ANOVA|2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms||2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms||0.09|-0.24|0.24
91773830|NCT01183689|183428870|SUPERIORITY||Mean Difference (Net)|-0.15||||0.24|TWO_SIDED|95.0|-0.32|0.02||This p-value is from the 2 degree of freedom test of differences among the 3 arms.|ANOVA|||Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.||0.02|-0.32|0.24
91773831|NCT01183689|183428871|SUPERIORITY||Mean Difference (Net)|1.52||||0.16|TWO_SIDED|95.0|-0.77|3.81||This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.|ANOVA|||Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.||3.81|-0.77|0.16
91773832|NCT01183689|183428871|SUPERIORITY||Mean Difference (Net)|2.21||||0.16|TWO_SIDED|95.0|-0.09|4.51||This p-value is from a 2 degree of freedom F test.|ANOVA|||Analysis of variance was used to compared mean differences among the 3 groups.||4.51|-0.09|0.16
91773833|NCT01183689|183428872|SUPERIORITY||Mean Difference (Net)|0.17||||0.75|TWO_SIDED|95.0|-3.89|4.23||This p-value is from a 2 degree of freedom F-test from analysis of variance.|ANOVA|||Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||4.23|-3.89|0.75
91773834|NCT01183689|183428872|SUPERIORITY||Mean Difference (Net)|1.44||||0.75|TWO_SIDED|95.0|-2.61|5.49||This p-value is from a 2 degree of freedom test.|ANOVA||No significant differences between groups 1 and 3.|Analysis of variance was used to compare mean changes among the 3 groups.||5.49|-2.61|0.75
91773835|NCT01183689|183428873|SUPERIORITY||Mean Difference (Net)|-1.08||||0.05|TWO_SIDED|95.0|-2.44|0.28||This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.|ANOVA||No significant difference between groups 1 and 2.|Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||0.28|-2.44|0.05
91773836|NCT01183689|183428873|SUPERIORITY||Mean Difference (Net)|-1.66||||0.05|TWO_SIDED|95.0|-3.0|-0.32||This p-value is from an F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.32|-3.00|0.05
91519980|NCT03923959|182914071|SUPERIORITY||Odds Ratio (OR)|1.013|STANDARD_ERROR_OF_MEAN|0.307||0.966|TWO_SIDED|95.0|0.5597|1.834|||Regression, Logistic||||A two-sample proportion test was also completed; the test utilized an α \< 0.049 to account for the O'Brien-Fleming adjustment. The p-value for the two-sample proportion test was 0.966.|1.834|0.5597|0.966
91773837|NCT01183689|183428874|SUPERIORITY||Mean Difference (Net)|-0.46||||0.03|TWO_SIDED|95.0|-1.37|0.45||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.|ANOVA|||Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.||0.45|-1.37|0.03
91773838|NCT01183689|183428874|SUPERIORITY||Mean Difference (Net)|-1.21||||0.03|TWO_SIDED|95.0|-2.11|-0.3||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.||-0.30|-2.11|0.03
91519981|NCT03923959|182914072|SUPERIORITY|||||||0.183||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.183
91773839|NCT01183689|183428875|SUPERIORITY||Mean Difference (Net)|1.08||||0.2|TWO_SIDED|95.0|-0.84|3.0||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.|ANOVA||The 95% confidence interval for differences between groups 1 and 2 includes 0.|Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.||3.00|-0.84|0.20
91773840|NCT01183689|183428875|SUPERIORITY||Mean Difference (Net)|-0.05||||0.2|TWO_SIDED|95.0|-1.45|1.35||This p-value is from an analysis of variance comparing all 3 groups.|ANOVA||The 95% confidence interval for differences between groups 1 and 3 includes 0.|Analysis of variance was used to compare differences among the 3 groups.||1.35|-1.45|0.20
91773841|NCT01183689|183428876|SUPERIORITY||Mean Difference (Net)|-0.12||||0.02|TWO_SIDED|95.0|-0.34|0.1||2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes|ANOVA|||2 degree of freedom F-test to compare mean 2 year differences among 3 arms||0.10|-0.34|0.02
91773842|NCT01183689|183428876|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.52|-0.08||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.08|-0.52|0.02
91773843|NCT01183689|183428877|SUPERIORITY||Mean Difference (Net)|-52.0||||0.58|TWO_SIDED|95.0|-164.0|60.0||2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories|ANOVA|||2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2||60|-164|0.58
91773844|NCT01183689|183428877|SUPERIORITY||Mean Difference (Net)|-50.0||||0.58|TWO_SIDED|95.0|-162.0|61.0||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups|ANOVA|||Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.||61|-162|0.58
91773845|NCT01183689|183428878|SUPERIORITY||Mean Difference (Net)|-1.27||||0.001|TWO_SIDED|95.0|-2.55|0.02||2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms|ANOVA|No adjustment to degrees of freedom|Difference between groups 1 and 2: 95% confidence interval includes 0|2 degree of freedom F-test from ANOVA to compare differences among 3 arms||0.02|-2.55|0.001
91773846|NCT01183689|183428878|SUPERIORITY||Mean Difference (Net)|-2.42||||0.001|TWO_SIDED|95.0|-3.69|-1.14||The p-value is from a 2 degree of freedom F-test for differences among the 3 arms|ANOVA||The 95% confidence interval for differences between groups 1 and 3 does not include 0.|Mean change in waist girth from baseline to year 2||-1.14|-3.69|0.001
91773847|NCT01183689|183428879|SUPERIORITY|Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.|Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.04|3.02||This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.|Regression, Logistic||The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.|Logistic regression to compare differences among the 3 groups||3.02|1.04|0.004
91773848|NCT01183689|183428879|SUPERIORITY||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.4|3.94||2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms|Regression, Logistic|No adjustments|The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.|Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.||3.94|1.40|0.004
91773849|NCT01690052|183428883|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The p-value is calculated from the ANOVA||||||0.05
91773850|NCT01194830|183428888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0005||95.0|-0.91|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.91|0.0005
91773851|NCT01194830|183428889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.62|-0.22|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.22|-0.62|<0.0001
91773852|NCT01194830|183428890|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0002||95.0|-0.84|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.84|0.0002
91773853|NCT01194830|183428891|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003||95.0|-0.85|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.85|0.0003
91773854|NCT01194830|183428892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.063||||0.001|TWO_SIDED|95.0|1.764|9.358|||Regression, Logistic|||||9.358|1.764|0.0010
91773855|NCT01194830|183428893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.433||||0.0352|TWO_SIDED|95.0|1.124|26.26|||Regression, Logistic|||||26.260|1.124|0.0352
91773856|NCT01194830|183428894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.951||||0.0003|TWO_SIDED|95.0|1.651|5.274|||Regression, Logistic|||||5.274|1.651|0.0003
91773857|NCT01194830|183428895|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|7.2||0.0972||95.0|-26.1|2.2|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and number of other Oral Antidiabetic Drugs||||2.2|-26.1|0.0972
91773858|NCT01194830|183428896|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|24.45||0.9368||95.0|-53.8|49.86|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline 2-hour PPG, and number of other Oral Antidiabetic Drugs||||49.86|-53.80|0.9368
91773859|NCT03583099|183428932|SUPERIORITY||Difference in proportion|4.0||||0.47|TWO_SIDED|95.0|-6.9|15.0|||generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-6.9|0.47
91773860|NCT03583099|183428933|SUPERIORITY||Difference in proportion|10.4||||0.05|TWO_SIDED|95.0|0.1|20.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||20.7|0.1|0.05
91773861|NCT03583099|183428934|SUPERIORITY||Difference in proportion|1.3||||0.75|TWO_SIDED|95.0|-6.7|9.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.2|-6.7|0.75
91519982|NCT03923959|182914073|SUPERIORITY|||||||0.729||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.729
91773862|NCT03583099|183428935|SUPERIORITY||Difference in proportion|-2.7||||0.54|TWO_SIDED|95.0|-11.5|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||6.1|-11.5|0.54
91773863|NCT03583099|183428936|SUPERIORITY||Difference in proportion|5.1||||0.16|TWO_SIDED|95.0|-2.1|12.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.3|-2.1|0.16
91773864|NCT03583099|183428937|SUPERIORITY||Difference in proportion|-0.6||||0.82|TWO_SIDED|95.0|-6.4|5.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.1|-6.4|0.82
91773865|NCT03583099|183428938|SUPERIORITY||Difference in proportion|-6.3||||0.06|TWO_SIDED|95.0|-13.0|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-13.0|0.06
91773866|NCT03583099|183428939|SUPERIORITY||Difference in proportion|-2.5||||0.68|TWO_SIDED|95.0|-14.5|9.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||9.5|-14.5|0.68
91773867|NCT03583099|183428940|SUPERIORITY||Difference in proportion|13.3||||0.19|TWO_SIDED|95.0|-6.72|33.38|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||33.38|-6.72|0.19
91773868|NCT03583099|183428941|SUPERIORITY||Difference in proportion|0.85||||0.93|TWO_SIDED|95.0|-17.82|19.52|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||19.52|-17.82|0.93
91773869|NCT03583099|183428942|SUPERIORITY||Difference in proportion|6.83||||0.45|TWO_SIDED|95.0|-10.84|24.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||24.50|-10.84|0.45
91773870|NCT03583099|183428943|SUPERIORITY||Difference in proportion|7.6||||0.41|TWO_SIDED|95.0|-10.58|25.78|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.78|-10.58|0.41
91773871|NCT03583099|183428944|SUPERIORITY||Difference in proportion|1.85||||0.81|TWO_SIDED|95.0|-13.17|16.88|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.88|-13.17|0.81
91773872|NCT03583099|183428945|SUPERIORITY||Difference in proportion|8.01||||0.51|TWO_SIDED|95.0|-15.38|31.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||31.40|-15.38|0.51
91773873|NCT03583099|183428946|SUPERIORITY||Difference in proportion|-10.34||||0.41|TWO_SIDED|95.0|-34.78|14.09|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.09|-34.78|0.41
91773874|NCT03583099|183428947|SUPERIORITY||Difference in proportion|-3.94||||0.76|TWO_SIDED|95.0|-31.03|23.16|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.16|-31.03|0.76
91773875|NCT03583099|183428948|SUPERIORITY||Difference in proportion|-0.76||||0.95|TWO_SIDED|95.0|-25.36|23.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.83|-25.36|0.95
91773876|NCT03583099|183428949|SUPERIORITY||Difference in means|-0.32||||0.55|TWO_SIDED|95.0|-2.01|1.36||The p-value is adjusted for baseline CAT score.|Mixed Models Analysis||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.36|-2.01|0.55
91773877|NCT03583099|183428950|SUPERIORITY||Difference in proportion|8.7||||0.05|TWO_SIDED|95.0|-0.1|17.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.4|-0.1|0.05
91773878|NCT03583099|183428951|SUPERIORITY||Difference in proportion|1.81||||0.88|TWO_SIDED|95.0|-21.47|25.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.08|-21.47|0.88
91519983|NCT03923959|182914074|SUPERIORITY|||||||0.655||||||a priori threshold for statistical significance was the standard α = 0.05|Chi-squared|||||||0.655
91519984|NCT03923959|182914075|SUPERIORITY|||||||0.7832||||||a priori threshold for statistical significance was the standard α = 0.05.|t-test, 2 sided|||||||0.7832
91773879|NCT03583099|183428952|SUPERIORITY||Difference in proportion|-5.62||||0.53|TWO_SIDED|95.0|-23.21|11.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.97|-23.21|0.53
91773880|NCT03583099|183428953|SUPERIORITY||Difference in proportion|10.68||||0.24|TWO_SIDED|95.0|-7.27|28.63|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||28.63|-7.27|0.24
91773881|NCT03583099|183428954|SUPERIORITY||Difference in proportion|-13.55||||0.19|TWO_SIDED|95.0|-33.65|6.55|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.55|-33.65|0.19
91773882|NCT03583099|183428955|SUPERIORITY||Difference in proportion|0.38||||0.95|TWO_SIDED|95.0|-12.5|13.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.27|-12.50|0.95
91773883|NCT03583099|183428956|SUPERIORITY||Difference in proportion|-6.97||||0.14|TWO_SIDED|95.0|-16.12|2.17|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.17|-16.12|0.14
91773884|NCT03583099|183428957|SUPERIORITY||Difference in proportion|-1.06||||0.87|TWO_SIDED|95.0|-13.39|11.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.27|-13.39|0.87
91773885|NCT03583099|183428958|SUPERIORITY||Difference in proportion|-1.8||||0.81|TWO_SIDED|95.0|-15.9|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-15.9|0.81
91773886|NCT03583099|183428959|SUPERIORITY||Difference in proportion|2.3||||0.63|TWO_SIDED|95.0|-7.2|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-7.2|0.63
91773887|NCT03583099|183428960|SUPERIORITY||Difference in proportion|5.8||||0.17|TWO_SIDED|95.0|-2.5|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-2.5|0.17
91773888|NCT03583099|183428961|SUPERIORITY||Difference in proportion|-2.9||||0.58|TWO_SIDED|95.0|-13.0|7.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.3|-13.0|0.58
91773889|NCT03583099|183428962|SUPERIORITY||Difference in proportion|-0.6||||0.89|TWO_SIDED|95.0|-8.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-8.3|0.89
91773890|NCT03583099|183428963|SUPERIORITY||Difference in proportion|-3.9||||0.16|TWO_SIDED|95.0|-9.2|1.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.5|-9.2|0.16
91773891|NCT03583099|183428964|SUPERIORITY||Difference in proportion|-2.2||||0.62|TWO_SIDED|95.0|-10.9|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-10.9|0.62
91773892|NCT03583099|183428965|SUPERIORITY||Difference in proportion|-1.64||||0.84|TWO_SIDED|95.0|-17.27|13.99|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.99|-17.27|0.84
91773893|NCT03583099|183428966|SUPERIORITY||Difference in proportion|6.09||||0.27|TWO_SIDED|95.0|-4.63|16.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.80|-4.63|0.27
91773894|NCT03583099|183428967|SUPERIORITY||Difference in proportion|2.91||||0.55|TWO_SIDED|95.0|-6.59|12.41|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.41|-6.59|0.55
91773895|NCT03583099|183428968|SUPERIORITY||Difference in proportion|2.37||||0.69|TWO_SIDED|95.0|-9.09|13.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.83|-9.09|0.69
91773896|NCT03583099|183428969|SUPERIORITY||Difference in proportion|0.36||||0.93|TWO_SIDED|95.0|-8.13|8.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.85|-8.13|0.93
91773897|NCT03583099|183428970|SUPERIORITY||Difference in proportion|-4.01||||0.26|TWO_SIDED|95.0|-10.97|2.95|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.95|-10.97|0.26
91773898|NCT03583099|183428971|SUPERIORITY||Difference in proportion|-2.04||||0.74|TWO_SIDED|95.0|-14.28|10.21|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.21|-14.28|0.74
91707898|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5409|STANDARD_ERROR_OF_MEAN|0.0729|||TWO_SIDED|90.0|0.411|0.6707|||Mixed Models Analysis|||Day 7, Hour 2||0.6707|0.4110|
91773899|NCT03583099|183428972|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
91773900|NCT03583099|183428973|SUPERIORITY||Difference in proportion|2.6||||0.46|TWO_SIDED|95.0|-4.3|9.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.6|-4.3|0.46
91773901|NCT03583099|183428974|SUPERIORITY||Difference in proportion|1.5||||0.5|TWO_SIDED|95.0|-3.0|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.1|-3.0|0.50
91707899|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5235|STANDARD_ERROR_OF_MEAN|0.0675|||TWO_SIDED|90.0|0.4032|0.6438|||Mixed Models Analysis|||Day 7, Hour 4||0.6438|0.4032|
91773902|NCT03583099|183428975|SUPERIORITY||Difference in proportion|-0.2||||0.96|TWO_SIDED|95.0|-6.8|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-6.8|0.96
91773903|NCT03583099|183428976|SUPERIORITY||Difference in proportion|2.2||||0.4|TWO_SIDED|95.0|-3.0|7.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.5|-3.0|0.40
91773904|NCT03583099|183428977|SUPERIORITY||Difference in proportion|-0.1||||0.96|TWO_SIDED|95.0|-4.3|4.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.0|-4.3|0.96
91773905|NCT03583099|183428978|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
91773906|NCT03583099|183428979|SUPERIORITY||Difference in proportion|-4.2||||0.46|TWO_SIDED|95.0|-15.2|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-15.2|0.46
91773907|NCT03583099|183428980|SUPERIORITY||Difference in proportion|3.9||||0.37|TWO_SIDED|95.0|-4.7|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-4.7|0.37
91773908|NCT03583099|183428981|SUPERIORITY||Difference in proportion|-0.8||||0.75|TWO_SIDED|95.0|-6.0|4.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.4|-6.0|0.75
91773909|NCT03583099|183428982|SUPERIORITY||Difference in proportion|-8.7||||0.08|TWO_SIDED|95.0|-18.3|0.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.9|-18.3|0.08
91773910|NCT03583099|183428983|SUPERIORITY||Difference in proportion|-4.8||||0.11|TWO_SIDED|95.0|-10.6|1.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.1|-10.6|0.11
91773911|NCT03583099|183428984|SUPERIORITY||Difference in proportion|0.4||||0.89|TWO_SIDED|95.0|-5.1|5.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.9|-5.1|0.89
91773912|NCT03583099|183428985|SUPERIORITY||Difference in proportion|-8.8||||0.05|TWO_SIDED|95.0|-17.5|0.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.0|-17.5|0.05
91773913|NCT03583099|183428986|SUPERIORITY||Difference in proportion|16.76||||0.09|TWO_SIDED|95.0|-2.89|36.42|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||36.42|-2.89|0.09
91773914|NCT03583099|183428987|SUPERIORITY||Difference in proportion|3.7||||0.56|TWO_SIDED|95.0|-8.6|15.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.9|-8.6|0.56
91773915|NCT03583099|183428988|SUPERIORITY||Difference in proportion|10.41||||0.49|TWO_SIDED|95.0|-19.39|40.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||40.20|-19.39|0.49
91773916|NCT03583099|183428989|SUPERIORITY||Difference in proportion|10.8||||0.06|TWO_SIDED|95.0|-0.5|22.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||22.1|-0.5|0.06
91773917|NCT03583099|183428990|SUPERIORITY||Difference in proportion|0.41||||0.94|TWO_SIDED|95.0|-10.97|11.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.79|-10.97|0.94
91773918|NCT03583099|183428991|SUPERIORITY||Difference in proportion|2.7||||0.57|TWO_SIDED|95.0|-6.5|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-6.5|0.57
91773919|NCT03583099|183428992|SUPERIORITY||Difference in proportion|1.36||||0.89|TWO_SIDED|95.0|-18.01|20.73|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||20.73|-18.01|0.89
91773920|NCT03583099|183428993|SUPERIORITY||Difference in proportion|-2.2||||0.65|TWO_SIDED|95.0|-12.1|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-12.1|0.65
91773921|NCT03583099|183428994|SUPERIORITY||Difference in proportion|12.48||||0.16|TWO_SIDED|95.0|-5.0|29.96|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||29.96|-5.00|0.16
91773922|NCT03583099|183428995|SUPERIORITY||Difference in proportion|4.3||||0.29|TWO_SIDED|95.0|-3.6|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-3.6|0.29
91773923|NCT03583099|183428996|SUPERIORITY||Difference in proportion|5.28||||0.44|TWO_SIDED|95.0|-8.07|18.62|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.62|-8.07|0.44
91773924|NCT03583099|183428997|SUPERIORITY||Difference in proportion|-1.5||||0.62|TWO_SIDED|95.0|-7.6|4.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.5|-7.6|0.62
91773925|NCT03583099|183428998|SUPERIORITY||Difference in proportion|-7.1||||0.39|TWO_SIDED|95.0|-23.18|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-23.18|0.39
91773926|NCT03583099|183428999|SUPERIORITY||Difference in proportion|-6.6||||0.08|TWO_SIDED|95.0|-13.9|0.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.8|-13.9|0.08
91773927|NCT03583099|183429000|SUPERIORITY||Difference in proportion|-11.3||||0.23|TWO_SIDED|95.0|-29.06|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.00|-29.06|0.23
91773928|NCT03583099|183429001|SUPERIORITY||Difference in means|-1.14||||0.97|TWO_SIDED|95.0|-6.42|4.13||The p-value adjusts for baseline CAT score.|Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.13|-6.42|0.97
91773929|NCT03583099|183429002|SUPERIORITY||Difference in means|-0.003||||0.47|TWO_SIDED|95.0|-1.86|1.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.85|-1.86|0.47
91773930|NCT03583099|183429003|SUPERIORITY||Difference in proportion|17.84||||0.02|TWO_SIDED|95.0|2.34|33.34|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||33.34|2.34|0.02
91773931|NCT03583099|183429004|SUPERIORITY||Difference in proportion|7.8||||0.12|TWO_SIDED|95.0|-2.0|17.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.6|-2.0|0.12
91773932|NCT03583099|183429005|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test. This test is appropriate since only one outcome per practice was seen.||||||1.0
91773933|NCT03583099|183429006|SUPERIORITY||Difference in proportion|2.06||||0.87|TWO_SIDED|95.0|-22.67|26.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||26.79|-22.67|0.87
91773934|NCT03583099|183429007|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
91773935|NCT03583099|183429008|SUPERIORITY||Difference in proportion|-5.53||||0.56|TWO_SIDED|95.0|-24.33|13.28|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.28|-24.33|0.56
91773936|NCT03583099|183429009|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
91773937|NCT03583099|183429010|SUPERIORITY||Difference in proportion|12.66||||0.21|TWO_SIDED|95.0|-7.05|32.37|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||32.37|-7.05|0.21
91773938|NCT03583099|183429011|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
91773939|NCT03583099|183429012|SUPERIORITY||Difference in proportion|-18.29||||0.08|TWO_SIDED|95.0|-38.66|2.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.08|-38.66|0.08
91773940|NCT03583099|183429013|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
91773941|NCT03583099|183429014|SUPERIORITY||Difference in proportion|-0.67||||0.92|TWO_SIDED|95.0|-14.06|12.71|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.71|-14.06|0.92
91773942|NCT03583099|183429016|SUPERIORITY||Difference in proportion|-5.47||||0.29|TWO_SIDED|95.0|-15.72|4.77|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.77|-15.72|0.29
91773943|NCT03583099|183429018|SUPERIORITY||Difference in proportion|-2.87||||0.69|TWO_SIDED|95.0|-17.14|11.39|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.39|-17.14|0.69
91773944|NCT03583099|183429019|SUPERIORITY||Difference in proportion|-13.15||||0.32|TWO_SIDED|95.0|-39.06|12.76|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.76|-39.06|0.32
91773945|NCT03583099|183429020|SUPERIORITY||Difference in proportion|-0.2||||0.98|TWO_SIDED|95.0|-15.5|15.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-15.5|0.98
91773946|NCT03583099|183429022|SUPERIORITY||Difference in proportion|3.1||||0.55|TWO_SIDED|95.0|-7.0|13.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.1|-7.0|0.55
91773947|NCT03583099|183429023|SUPERIORITY||Difference in proportion|-8.61||||0.43|TWO_SIDED|95.0|-30.19|12.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.97|-30.19|0.43
91773948|NCT03583099|183429024|SUPERIORITY||Difference in proportion|7.6||||0.1|TWO_SIDED|95.0|-1.4|16.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.5|-1.4|0.10
91773949|NCT03583099|183429025|SUPERIORITY||Difference in proportion|0.82||||0.94|TWO_SIDED|95.0|-20.92|21.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||21.92|-20.92|0.94
91773950|NCT03583099|183429026|SUPERIORITY||Difference in proportion|-3.4||||0.55|TWO_SIDED|95.0|-14.4|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-14.4|0.55
91773951|NCT03583099|183429028|SUPERIORITY||Difference in proportion|-1.1||||0.8|TWO_SIDED|95.0|-9.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-9.3|0.80
91773952|NCT03583099|183429030|SUPERIORITY||Difference in proportion|-3.9||||0.18|TWO_SIDED|95.0|-9.7|1.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.8|-9.7|0.18
91773953|NCT03583099|183429031|SUPERIORITY||Difference in proportion|-0.17||||0.99|TWO_SIDED|95.0|-26.06|25.72|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.72|-26.06|0.99
91773954|NCT03583099|183429032|SUPERIORITY||Difference in proportion|-2.6||||0.59|TWO_SIDED|95.0|-12.0|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-12.0|0.59
91773955|NCT03583099|183429034|SUPERIORITY||Difference in proportion|1.9||||0.82|TWO_SIDED|95.0|-14.5|18.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.4|-14.5|0.82
91773956|NCT03583099|183429036|SUPERIORITY||Difference in proportion|7.6||||0.2|TWO_SIDED|95.0|-4.1|19.3|||Wilcoxon (Mann-Whitney)||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.3|-4.1|0.20
91773957|NCT03583099|183429038|SUPERIORITY||Difference in proportion|4.9||||0.36|TWO_SIDED|95.0|-5.5|15.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.3|-5.5|0.36
91773958|NCT03583099|183429040|SUPERIORITY||Difference in proportion|4.6||||0.47|TWO_SIDED|95.0|-7.9|17.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.1|-7.9|0.47
91773959|NCT03583099|183429042|SUPERIORITY||Difference in proportion|0.6||||0.88|TWO_SIDED|95.0|-7.8|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-7.8|0.88
91773960|NCT03583099|183429044|SUPERIORITY||Difference in proportion|-4.3||||0.27|TWO_SIDED|95.0|-12.0|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-12.0|0.27
91773961|NCT03583099|183429045|SUPERIORITY||Difference in proportion|-4.94||||0.82|TWO_SIDED|95.0|-47.92|38.04|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||38.04|-47.92|0.82
91773962|NCT03583099|183429046|SUPERIORITY||Difference in proportion|-1.1||||0.87|TWO_SIDED|95.0|-14.5|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-14.5|0.87
91707900|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3857|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.2944|0.4769|||Mixed Models Analysis|||Day 7, Hour 8||0.4769|0.2944|
91773963|NCT03583099|183429047|SUPERIORITY||Difference in proportion|-37.6||||0.03|TWO_SIDED|95.0|-71.8|-3.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-3.5|-71.8|0.03
91773964|NCT03583099|183429048|SUPERIORITY||Difference in proportion|2.3||||0.56|TWO_SIDED|95.0|-5.6|10.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.3|-5.6|0.56
91773965|NCT03583099|183429049|SUPERIORITY||Difference in proportion|-23.07||||0.06|TWO_SIDED|95.0|-47.4|1.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.27|-47.40|0.06
91773966|NCT03583099|183429050|SUPERIORITY||Difference in proportion|3.2||||0.39|TWO_SIDED|95.0|-4.0|10.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.4|-4.0|0.39
91773967|NCT03583099|183429051|SUPERIORITY||Difference in proportion|-1.72||||0.84|TWO_SIDED|95.0|-18.24|14.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.80|-18.24|0.84
91773968|NCT03583099|183429052|SUPERIORITY||Difference in proportion|2.0||||0.42|TWO_SIDED|95.0|-2.9|6.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.9|-2.9|0.42
91773969|NCT03583099|183429053|SUPERIORITY||Difference in proportion|-42.09||||0.01|TWO_SIDED|95.0|-74.27|-9.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-9.92|-74.27|0.01
91773970|NCT03583099|183429054|SUPERIORITY||Difference in proportion|2.4||||0.47|TWO_SIDED|95.0|-4.2|9.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.1|-4.2|0.47
91773971|NCT03583099|183429055|SUPERIORITY||Difference in proportion|-12.27||||0.34|TWO_SIDED|95.0|-37.72|13.18|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.18|-37.72|0.34
91773972|NCT03583099|183429056|SUPERIORITY||Difference in proportion|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-3.1|0.39
91773973|NCT03583099|183429058|SUPERIORITY||Difference in proportion|-1.2||||0.59|TWO_SIDED|95.0|-5.5|3.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.1|-5.5|0.59
91773974|NCT03583099|183429060|SUPERIORITY||Difference in proportion|0.3||||0.94|TWO_SIDED|95.0|-8.2|8.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.8|-8.2|0.94
91773975|NCT03583099|183429061|SUPERIORITY||Difference in proportion|0.6||||0.93|TWO_SIDED|95.0|-12.2|13.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.4|-12.2|0.93
91773976|NCT03583099|183429062|SUPERIORITY||Difference in proportion|-8.2||||0.25|TWO_SIDED|95.0|-22.0|5.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.7|-22.0|0.25
91773977|NCT03583099|183429063|SUPERIORITY||Difference in proportion|-3.4||||0.48|TWO_SIDED|95.0|-12.7|6.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.0|-12.7|0.48
91773978|NCT03583099|183429064|SUPERIORITY||Difference in proportion|3.9||||0.45|TWO_SIDED|95.0|-6.3|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-6.3|0.45
91773979|NCT03583099|183429066|SUPERIORITY||Difference in proportion|-2.2||||0.48|TWO_SIDED|95.0|-8.4|3.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.9|-8.4|0.48
91773980|NCT03583099|183429067|SUPERIORITY||Difference in proportion|-0.4||||0.97|TWO_SIDED|95.0|-20.4|19.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.5|-20.4|0.97
91773981|NCT03583099|183429068|SUPERIORITY||Difference in proportion|-12.1||||0.04|TWO_SIDED|95.0|-23.5|-0.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.6|-23.5|0.04
91707901|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0216|STANDARD_ERROR_OF_MEAN|0.0368|||TWO_SIDED|90.0|-0.0439|0.0872|||Mixed Models Analysis|||Day 7, Hour 12||0.0872|-0.0439|
91773982|NCT03583099|183429069|SUPERIORITY||Difference in proportion|-1.8||||0.39|TWO_SIDED|95.0|-5.8|2.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.3|-5.8|0.39
91773983|NCT03583099|183429070|SUPERIORITY||Difference in proportion|-7.3||||0.06|TWO_SIDED|95.0|-14.9|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-14.9|0.06
91773984|NCT03583099|183429071|SUPERIORITY||Difference in proportion|-0.9||||0.82|TWO_SIDED|95.0|-8.8|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.0|-8.8|0.82
91773985|NCT03583099|183429072|SUPERIORITY||Difference in proportion|0.6||||0.86|TWO_SIDED|95.0|-6.6|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-6.6|0.86
91773986|NCT03583099|183429073|SUPERIORITY||Difference in proportion|-7.4||||0.14|TWO_SIDED|95.0|-17.3|2.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.5|-17.3|0.14
91773987|NCT03583099|183429075|SUPERIORITY||Difference in proportion|-14.66||||0.21|TWO_SIDED|95.0|-37.54|8.22|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.22|-37.54|0.21
91773988|NCT03583099|183429076|SUPERIORITY||Difference in proportion|0.4||||0.76|TWO_SIDED|95.0|-2.0|2.7|||Generalized estimating equation contrast|||||2.7|-2.0|0.76
91773989|NCT03583099|183429079|SUPERIORITY||Difference in proportion|0.6||||0.66|TWO_SIDED|95.0|-2.1|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-2.1|0.66
91773990|NCT00807911|183429097|OTHER||Hazard Ratio (HR)|0.657||||0.047|TWO_SIDED|95.0|0.434|0.994|||t-test, 1 sided|||||0.994|0.434|0.047
91773991|NCT00807911|183429098|OTHER||Hazard Ratio (HR)|0.602||||0.04|TWO_SIDED|95.0|0.371|0.977|||t-test, 1 sided|||||0.977|0.371|0.040
91773992|NCT00807911|183429099|OTHER||Hazard Ratio (HR)|0.744||||0.47|TWO_SIDED|95.0|0.334|1.657|||t-test, 1 sided|||||1.657|0.334|0.47
91773993|NCT00807911|183429100|OTHER||Hazard Ratio (HR)|0.456||||0.036|TWO_SIDED|95.0|0.215|0.97|||t-test, 1 sided|||||0.970|0.215|0.036
91773994|NCT02648204|183429109|NON_INFERIORITY|Non-Inferiority margin: 0.4|Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
91773995|NCT02648204|183429109|SUPERIORITY||Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
91773996|NCT02648204|183429109|NON_INFERIORITY|Non-Inferiority margin: 0.04|Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
91773997|NCT02648204|183429109|SUPERIORITY||Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
91773998|NCT02648204|183429110|SUPERIORITY||Treatment difference|-2.26|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.02|-1.51|||Mixed Models Analysis|||||-1.51|-3.02|<0.0001
91773999|NCT02648204|183429110|SUPERIORITY||Treatment difference|-3.55|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.32|-2.78|||Mixed Models Analysis|||||-2.78|-4.32|<0.0001
91774000|NCT01018030|183429149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.386||||0.008|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.10|-0.67|0.008
91774001|NCT01018030|183429149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.357||||0.014|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.07|-0.64|0.014
91774002|NCT03111875|183429190|SUPERIORITY|common effect|Risk Ratio (RR)|1.04||||0.69|TWO_SIDED|95.6|0.87|1.24|||Mixed Models Analysis|||||1.24|0.87|0.69
91774003|NCT03111875|183429190|SUPERIORITY|average relative effect|Risk Ratio (RR)|0.68||||0.1|TWO_SIDED|95.6|0.43|1.08|||Mixed Models Analysis|||||1.08|0.43|0.10
91774004|NCT03111875|183429191|SUPERIORITY||Risk Ratio (RR)|1.13||||0.25|TWO_SIDED|98.75|0.87|1.47|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk).||||1.47|0.87|0.25
91774005|NCT03111875|183429192|SUPERIORITY||Risk Ratio (RR)|1.07||||0.41|TWO_SIDED|98.75|0.87|1.33|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk)||||1.33|0.87|0.41
91774006|NCT02588599|183429255|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t=8.0; df=53||||||<0.0001
91774007|NCT00402168|183429263|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.||14.9|2.1|
91774008|NCT00402168|183429263|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 12, difference in percentage of participants with acute rejection using exact method.||14.9|2.1|
91774009|NCT00402168|183429264|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.||6.1|-3.3|
91774010|NCT00402168|183429264|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.||6.1|-3.3|
91774011|NCT00402168|183429267|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-0.1|13.8||||||||13.8|-0.1|
91774012|NCT00402168|183429272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.4491|TWO_SIDED|95.0|-1.7|3.9|||ANCOVA|||Mental Component Scales (MCS)||3.9|-1.7|0.4491
91774013|NCT00402168|183429272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7892|TWO_SIDED|95.0|-2.5|1.9|||ANCOVA|||Physical Component Scales (PCS)||1.9|-2.5|0.7892
91774014|NCT00402168|183429274|SUPERIORITY_OR_OTHER||Estimated Difference|0.0076|||||TWO_SIDED|95.0|-0.01|0.0252||||||Difference in Symptom Occurrence between treatment groups.||.0252|-.010|
91774015|NCT00402168|183429274|SUPERIORITY_OR_OTHER||Estimated Difference|0.0148|||||TWO_SIDED|95.0|-0.002|0.0321||||||Difference in Symptom Distress between treatment groups.||.0321|-.002|
91774016|NCT00550407|183429290|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||||||0.010
91774017|NCT03883581|183429313|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91774018|NCT03883581|183429314|SUPERIORITY|||||||0.647|||||||Paired t test|||||||0.647
91774019|NCT03883581|183429315|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
91774020|NCT03883581|183429316|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
91774021|NCT03883581|183429317|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
91774022|NCT02099864|183429319|OTHER||Odds Ratio (OR)|10.0||||0.055|TWO_SIDED|95.0|0.9|108.8|||Fisher Exact|Due to sample size, Fisher's exact test was used rather than simple logistic regression.||||108.8|0.9|0.055
91774023|NCT02099864|183429320|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.1|5.3|||Fisher Exact|Due to sample size, Fisher's exact was used rather than regression.||||5.3|0.1|1.000
91774024|NCT02099864|183429321|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.0|17.0|||Fisher Exact|||||17.0|0.0|1.000
91774025|NCT02099864|183429322|OTHER||Median Difference (Final Values)|23.2||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.84
91774026|NCT02099864|183429323|OTHER||Median Difference (Final Values)|-1.9||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.14
91774027|NCT02099864|183429324|OTHER||Odds Ratio (OR)|2.7||||1|TWO_SIDED|95.0|0.1|60.2|||Fisher Exact|||||60.2|0.1|1.00
91774028|NCT02099864|183429326|OTHER||Median Difference (Final Values)|4.8||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for the responders minus the median for the non-responders.|||||0.01
91774029|NCT02099864|183429329|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
91774030|NCT02099864|183429330|OTHER||Hazard Ratio (HR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.56|||Regression, Cox|||||0.56|0.08|0.002
91774031|NCT02099864|183429331|OTHER||Hazard Ratio (HR)|0.23||||0.23|TWO_SIDED|95.0|0.02|0.59|||Regression, Cox|||||0.59|0.02|0.23
91774032|NCT02099864|183429332|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
91774033|NCT02099864|183429337|OTHER||Hazard Ratio (HR)|4.9|||<|0.001|TWO_SIDED|95.0|2.03|11.82|||Regression, Cox|||||11.82|2.03|<0.001
91774034|NCT03224130|183429338|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||||||0.21
91774035|NCT03224130|183429339|SUPERIORITY|||||||0.31|||||||Regression, Linear|||||||0.31
91774036|NCT03224130|183429340|SUPERIORITY|||||||0.24|||||||censored Poisson model|||||||0.24
91774037|NCT03224130|183429341|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
91774038|NCT03224130|183429342|SUPERIORITY|||||||0.5|||||||Regression, Logistic|||||||0.50
91774039|NCT03224130|183429343|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
91774040|NCT03224130|183429344|SUPERIORITY|||||||0.92|||||||Regression, Logistic|||||||0.92
91774041|NCT04673214|183429431|SUPERIORITY|The null hypothesis for the modification in the clinical evolution of the conjunctivitis sign in patients diagnosed with COVID-19 under early intervention treatment with Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call is rejected.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms|Chi-squared|||Null Hypothesis: There will be no modification in the clinical evolution ≥ 25% of patients diagnosed with COVID-19 under an early intervention treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call from U.M.F 13 and U.M.F 20 from I.M.S.S., during the period of December 2020- February 2021, with a power of 90%, type I error rate 1% and loss to follow-up 20%.||||0.05
91774042|NCT04673214|183429431|SUPERIORITY|The null hypothesis is rejected with a difference of 2 days in the modification of the clinical evolution (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID -19 in early intervention treatment. vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||||0.05|||||||t-test, 2 sided|||Assuming a difference of 2 days in the modification of the clinical course (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 in early intervention treatment vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of the twenty%||||0.05
91774043|NCT04673214|183429432|SUPERIORITY|Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with the outcome of improvement in the Modification of the clinical evolution of the symptoms of patients with COVID-19 using double therapy was reported 95.7% (n = 44) Vs. triple therapy 90.8% (n = 59) and therapeutic failure 4.3% (n = 2) vs. 9.2% (n = 6), respectively.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms the clinical modification and therapeutic failure of patients diagnosed with COVID-19|Chi-squared|||Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with COVID-19 under treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||0.05
91774044|NCT04673214|183429433|SUPERIORITY|The null hypothesis is rejected with a mean duration of 2 days with clinical symptoms of COVID-19 in early intervention treatment as a result of improving the modification of the clinical evolution of symptoms vs therapeutic failure.||||||0.05|||||||t-test, 2 sided|||Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%||||0.05
91774045|NCT04673214|183429434|SUPERIORITY|A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.||||||0.05|||||||Wilcoxon (Gehan) statistical test|||Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%||||0.05
91774046|NCT05546476|183429441|SUPERIORITY||Difference in Posterior Median|1.33|||||TWO_SIDED|90.0|0.49|2.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||2.34|0.49|
91774047|NCT05546476|183429441|SUPERIORITY||Difference in Posterior Median|2.08|||||TWO_SIDED|90.0|1.08|3.15||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||3.15|1.08|
91774048|NCT05546476|183429441|SUPERIORITY||Difference in Posterior Median|3.0|||||TWO_SIDED|90.0|1.68|4.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||4.34|1.68|
91774049|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|53.36|||=|0.826|TWO_SIDED|90.0|-40.89|147.6|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||147.60|-40.89|=0.8260
91774050|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|-37.9|||=|0.254|TWO_SIDED|90.0|-132.94|57.14|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||57.14|-132.94|=0.2540
91774051|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|-1.95|||=|0.487|TWO_SIDED|90.0|-101.63|97.73|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||97.73|-101.63|=0.4870
91774052|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|37.76|||=|0.0497|TWO_SIDED|90.0|0.07|75.46|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||75.46|0.07|=0.0497
91774053|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|-4.36|||=|0.5745|TWO_SIDED|90.0|-42.94|34.22|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||34.22|-42.94|=0.5745
91774054|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|49.85|||=|0.0189|TWO_SIDED|90.0|10.62|89.08|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||89.08|10.62|=0.0189
91774055|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|8.51|||=|0.1302|TWO_SIDED|90.0|-4.0|21.03|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.03|-4.00|=0.1302
91774056|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|4.49|||=|0.278|TWO_SIDED|90.0|-8.18|17.16|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||17.16|-8.18|=0.2780
91774057|NCT05546476|183429442|SUPERIORITY||Difference in LS Mean|8.11|||=|0.1529|TWO_SIDED|90.0|-5.01|21.23|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.23|-5.01|=0.1529
91774058|NCT05546476|183429443|SUPERIORITY||Difference in LS Mean|-130.27|||=|0.5762|TWO_SIDED|90.0|-1257.31|996.77|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||996.77|-1257.31|=0.5762
91774059|NCT05546476|183429443|SUPERIORITY||Difference in LS Mean|724.14|||=|0.1486|TWO_SIDED|90.0|-425.81|1874.09|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1874.09|-425.81|=0.1486
91774060|NCT05546476|183429443|SUPERIORITY||Difference in LS Mean|185.62|||=|0.3972|TWO_SIDED|90.0|-997.94|1369.18|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1369.18|-997.94|=0.3972
91774061|NCT05546476|183429444|SUPERIORITY||Difference in LS Mean|1587.26|||=|0.0985|TWO_SIDED|90.0|-443.79|3618.31|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3618.31|-443.79|=0.0985
91774062|NCT05546476|183429444|SUPERIORITY||Difference in LS Mean|-98.54|||=|0.5315|TWO_SIDED|90.0|-2169.67|1972.58|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1972.58|-2169.67|=0.5315
91774063|NCT05546476|183429444|SUPERIORITY||Difference in LS Mean|2203.18|||=|0.0437|TWO_SIDED|90.0|84.51|4321.85|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||4321.85|84.51|=0.0437
91774064|NCT05546476|183429445|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5052|TWO_SIDED|90.0|-0.046|0.045|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.046|=0.5052
91774065|NCT05546476|183429445|SUPERIORITY||Difference in LS Mean|-0.004|||=|0.5599|TWO_SIDED|90.0|-0.05|0.042|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.042|-0.050|=0.5599
91774066|NCT05546476|183429445|SUPERIORITY||Difference in LS Mean|0.017|||=|0.277|TWO_SIDED|90.0|-0.03|0.064|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.064|-0.030|=0.2770
91774067|NCT05546476|183429445|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5047|TWO_SIDED|90.0|-0.071|0.07|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.070|-0.071|=0.5047
91774068|NCT05546476|183429445|SUPERIORITY||Difference in LS Mean|-0.026|||=|0.7316|TWO_SIDED|90.0|-0.097|0.045|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.097|=0.7316
91774069|NCT05546476|183429445|SUPERIORITY||Difference in LS Mean|0.01|||=|0.4145|TWO_SIDED|90.0|-0.063|0.082|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.082|-0.063|=0.4145
91774070|NCT05546476|183429446|SUPERIORITY||Difference in LS Mean|4.24|||=|0.0114|TWO_SIDED|90.0|1.19|7.28|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.28|1.19|=0.0114
91774071|NCT05546476|183429446|SUPERIORITY||Difference in LS Mean|0.64|||=|0.36|TWO_SIDED|90.0|-2.3|3.57|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.57|-2.30|=0.3600
91707902|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1708|STANDARD_ERROR_OF_MEAN|0.0486|||TWO_SIDED|90.0|0.0841|0.2574|||Mixed Models Analysis|||Day 7, Hour 24||0.2574|0.0841|
91519985|NCT04575051|182914091|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.58|TWO_SIDED|95.0|-1.1|1.96|||Mixed Models Analysis||Difference in the adjusted means for the Consult model and HearCARE model.|The null hypothesis is that the HearCARE intervention does not improve satisfaction with social participation.||1.96|-1.10|0.58
91707903|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.166|STANDARD_ERROR_OF_MEAN|0.0377|||TWO_SIDED|90.0|0.0982|0.2338|||Mixed Models Analysis|||Day 14, pre-dose||0.2338|0.0982|
91707904|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3524|STANDARD_ERROR_OF_MEAN|0.0477|||TWO_SIDED|90.0|0.2667|0.438|||Mixed Models Analysis|||Day 14, Hour 1||0.4380|0.2667|
91707905|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5631|STANDARD_ERROR_OF_MEAN|0.0724|||TWO_SIDED|90.0|0.433|0.6932|||Mixed Models Analysis|||Day 14, Hour 2||0.6932|0.4330|
91707906|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5807|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|0.4549|0.7065|||Mixed Models Analysis|||Day 14, Hour 4||0.7065|0.4549|
91707907|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2814|STANDARD_ERROR_OF_MEAN|0.0627|||TWO_SIDED|90.0|0.1688|0.394|||Mixed Models Analysis|||Day 14, Hour 8||0.3940|0.1688|
91707908|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1982|STANDARD_ERROR_OF_MEAN|0.0577|||TWO_SIDED|90.0|0.0945|0.3019|||Mixed Models Analysis|||Day 14, Hour 12||0.3019|0.0945|
91707909|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1465|STANDARD_ERROR_OF_MEAN|0.0615|||TWO_SIDED|90.0|0.0361|0.2569|||Mixed Models Analysis|||Day 14, Hour 24||0.2569|0.0361|
91707910|NCT02187029|183309024|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8565|STANDARD_ERROR_OF_MEAN|0.4796|||TWO_SIDED|90.0|0.0017|1.7112|||Mixed Models Analysis|||Follow-up, Day 25-29||1.7112|0.0017|
91707911|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.707|0.01|||Mixed Models Analysis|||Day 1, Hour 1||0.010|-0.707|
91707912|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.533|0.175|||Mixed Models Analysis|||Day 1, Hour 2||0.175|-0.533|
91707913|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.258|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.568|0.052|||Mixed Models Analysis|||Day 1, Hour 4||0.052|-0.568|
91707914|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.046|STANDARD_ERROR_OF_MEAN|0.201||||90.0|-0.39|0.298|||Mixed Models Analysis|||Day 1, Hour 8||0.298|-0.390|
91707915|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.284|STANDARD_ERROR_OF_MEAN|0.168||||90.0|-0.575|0.006|||Mixed Models Analysis|||Day 1, Hour 12||0.006|-0.575|
91707916|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.166|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|90.0|-0.569|0.237|||Mixed Models Analysis|||Day 1, Hour 24||0.237|-0.569|
91707917|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.263|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.657|0.132|||Mixed Models Analysis|||Day 7, pre-dose||0.132|-0.657|
91707918|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.46|0.299|||Mixed Models Analysis|||Day 7, Hour 1||0.299|-0.460|
91707919|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.082|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.392|0.228|||Mixed Models Analysis|||Day 7, Hour 2||0.228|-0.392|
91707920|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.083|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|90.0|-0.408|0.242|||Mixed Models Analysis|||Day 7, Hour 4||0.242|-0.408|
91707921|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.207|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.508|0.095|||Mixed Models Analysis|||Day 7, Hour 8||0.095|-0.508|
91707922|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.451|0.191|||Mixed Models Analysis|||Day 7, Hour 12||0.191|-0.451|
91707923|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.445|0.196|||Mixed Models Analysis|||Day 7, Hour 24||0.196|-0.445|
91707924|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|90.0|-0.472|0.097|||Mixed Models Analysis|||Day 14, pre-dose||0.097|-0.472|
91707925|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.152|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.434|0.13|||Mixed Models Analysis|||Day 14, Hour 1||0.130|-0.434|
91707926|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.231|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|-0.504|0.043|||Mixed Models Analysis|||Day 14, Hour 2||0.043|-0.504|
91707927|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.405|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.722|-0.088|||Mixed Models Analysis|||Day 14, Hour 4||-0.088|-0.722|
91707928|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.249|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.56|0.062|||Mixed Models Analysis|||Day 14, Hour 8||0.062|-0.560|
91707929|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.163|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.467|0.141|||Mixed Models Analysis|||Day 14, Hour 12||0.141|-0.467|
91707930|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.317|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.633|-0.002|||Mixed Models Analysis|||Day 14, Hour 24||-0.002|-0.633|
91707931|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.094|STANDARD_ERROR_OF_MEAN|0.339|||TWO_SIDED|90.0|-0.683|0.496|||Mixed Models Analysis|||Follow-up, Day 25-29||0.496|-0.683|
91707932|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.406|0.505|||Mixed Models Analysis|||Day 1, Hour 1||0.505|-0.406|
91707933|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.257|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.193|0.707|||Mixed Models Analysis|||Day 1, Hour 2||0.707|-0.193|
91707934|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.091|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|90.0|-0.302|0.485|||Mixed Models Analysis|||Day 1, Hour 4||0.485|-0.302|
91707935|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.107|0.768|||Mixed Models Analysis|||Day 1, Hour 8||0.768|-0.107|
91707936|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.283|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.087|0.653|||Mixed Models Analysis|||Day 1, Hour 12||0.653|-0.087|
91707937|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.299|||TWO_SIDED|90.0|-0.024|1.0|||Mixed Models Analysis|||Day 1, Hour 24||1.000|-0.024|
91707938|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.327|||TWO_SIDED|90.0|-0.356|0.768|||Mixed Models Analysis|||Day 7, pre-dose||0.768|-0.356|
91707939|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.123|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.41|0.656|||Mixed Models Analysis|||Day 7, Hour 1||0.656|-0.410|
91707940|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.396|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|90.0|-0.025|0.818|||Mixed Models Analysis|||Day 7, Hour 2||0.818|-0.025|
91707941|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.523|0.368|||Mixed Models Analysis|||Day 7, Hour 4||0.368|-0.523|
91707942|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.254|STANDARD_ERROR_OF_MEAN|0.237|||TWO_SIDED|90.0|-0.154|0.661|||Mixed Models Analysis|||Day 7, Hour 8||0.661|-0.154|
91707943|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.564|0.315|||Mixed Models Analysis|||Day 7, Hour 12||0.315|-0.564|
91519986|NCT04575051|182914092|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.95|TWO_SIDED|95.0|-1.13|1.1|||Mixed Models Analysis||The estimated parameter represents the difference between the adjusted means for the Consult and HearCARE models.|The null hypothesis is that the HearCARE intervention does not improve hearing related quality of life.||1.10|-1.13|0.95
91707944|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.458|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|0.019|0.897|||Mixed Models Analysis|||Day 7, Hour 24||0.897|0.019|
91707945|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.418|STANDARD_ERROR_OF_MEAN|0.215|||TWO_SIDED|90.0|0.043|0.792|||Mixed Models Analysis|||Day 14, pre-dose||0.792|0.043|
91707946|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.213|||TWO_SIDED|90.0|0.15|0.893|||Mixed Models Analysis|||Day 14, Hour 1||0.893|0.150|
91707947|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|0.172|0.888|||Mixed Models Analysis|||Day 14, Hour 2||0.888|0.172|
91707948|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.357|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.069|0.782|||Mixed Models Analysis|||Day 14, Hour 4||0.782|-0.069|
91707949|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|90.0|-0.328|0.503|||Mixed Models Analysis|||Day 14, Hour 8||0.503|-0.328|
91707950|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|90.0|0.0|0.812|||Mixed Models Analysis|||Day 14, Hour 12||0.812|0.000|
91707951|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|0.377|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.047|0.802|||Mixed Models Analysis|||Day 14, Hour 24||0.802|-0.047|
91707952|NCT02187029|183309025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.418|||TWO_SIDED|90.0|-0.949|0.502|||Mixed Models Analysis|||Follow-up, Day 25-29||0.502|-0.949|
91707953|NCT02187029|183309026|SUPERIORITY_OR_OTHER||LS Mean Difference|316.89|STANDARD_ERROR_OF_MEAN|166.57|||TWO_SIDED|90.0|21.91|611.88|||Mixed Models Analysis|||Day 1||611.88|21.91|
91707954|NCT02187029|183309026|SUPERIORITY_OR_OTHER||LS Mean Difference|61.97|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|90.0|-94.87|218.82|||Mixed Models Analysis|||Day 7||218.82|-94.87|
91707955|NCT02187029|183309026|SUPERIORITY_OR_OTHER||LS Mean Difference|107.96|STANDARD_ERROR_OF_MEAN|100.38|||TWO_SIDED|90.0|-71.2|287.11|||Mixed Models Analysis|||Day 14||287.11|-71.20|
91707956|NCT02187029|183309026|SUPERIORITY_OR_OTHER||LS Mean Difference|433.21|STANDARD_ERROR_OF_MEAN|211.71|||TWO_SIDED|90.0|58.3|808.13|||Mixed Models Analysis|||Day 1||808.13|58.30|
91707957|NCT02187029|183309026|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2|STANDARD_ERROR_OF_MEAN|125.47|||TWO_SIDED|90.0|-208.07|234.47|||Mixed Models Analysis|||Day 7||234.47|-208.07|
91707958|NCT02187029|183309026|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.83|STANDARD_ERROR_OF_MEAN|142.95|||TWO_SIDED|90.0|-285.26|225.6|||Mixed Models Analysis|||Day 14||225.60|-285.26|
91707959|NCT02187029|183309027|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|0.71|6.17|||Mixed Models Analysis|||Day 1||6.17|0.71|
91707960|NCT02187029|183309027|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|1.97|5.37|||Mixed Models Analysis|||Day 7||5.37|1.97|
91707961|NCT02187029|183309027|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|6.24|9.96|||Mixed Models Analysis|||Day 14||9.96|6.24|
91707962|NCT02187029|183309027|SUPERIORITY_OR_OTHER||LS Mean Difference|13.12|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|90.0|9.65|16.59|||Mixed Models Analysis|||Day 1||16.59|9.65|
91707963|NCT02187029|183309027|SUPERIORITY_OR_OTHER||LS Mean Difference|27.99|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|25.49|30.49|||Mixed Models Analysis|||Day 7||30.49|25.49|
91707964|NCT02187029|183309027|SUPERIORITY_OR_OTHER||LS Mean Difference|28.77|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|26.14|31.41|||Mixed Models Analysis|||Day 14||31.41|26.14|
91707965|NCT02187029|183309028|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-1.31|3.1|||Mixed Models Analysis|||Day 1||3.10|-1.31|
91707966|NCT02187029|183309028|SUPERIORITY_OR_OTHER||LS Mean Difference|2.91|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|0.71|5.11|||Mixed Models Analysis|||Day 7||5.11|0.71|
91707967|NCT02187029|183309028|SUPERIORITY_OR_OTHER||LS Mean Difference|3.59|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|1.33|5.85|||Mixed Models Analysis|||Day 14||5.85|1.33|
91707968|NCT02187029|183309028|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-1.29|4.31|||Mixed Models Analysis|||Day 1||4.31|-1.29|
91707969|NCT02187029|183309028|SUPERIORITY_OR_OTHER||LS Mean Difference|7.73|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|4.57|10.89|||Mixed Models Analysis|||Day 7||10.89|4.57|
91707970|NCT02187029|183309028|SUPERIORITY_OR_OTHER||LS Mean Difference|9.07|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.91|12.23|||Mixed Models Analysis|||Day 14||12.23|5.91|
91707971|NCT01537835|183309074|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||0.17
91707972|NCT01535443|183309083|OTHER|||||||0.374|||||||Traza Pillai|The test was performed with degrees of freedom: 2||||||.374
91707973|NCT03224624|183309105|EQUIVALENCE|Comparing baseline-\>12month SBP change (mean difference) between the two groups.|Mean Difference (Net)|-1.35|STANDARD_ERROR_OF_MEAN|3.8||0.72|TWO_SIDED|||||p\<0.05 considered significant.|t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in SBP|t- tests were done to compare group mean differences between self-management and usual care and within groups Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.72
91707974|NCT03224624|183309105|EQUIVALENCE|Comparing baseline-\>12month DBP change (mean difference) between the two groups.|Mean Difference (Net)|-3.75|STANDARD_ERROR_OF_MEAN|2.55||0.15|TWO_SIDED||||||t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in DBP|Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.15
91707975|NCT03224624|183309105|EQUIVALENCE|Comparing baseline-\>12month SBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-6.95||||0.01|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for self-management group (as given in table)|change in SBP from baseline to 12-months within self-management group.||||0.01
91707976|NCT03224624|183309105|EQUIVALENCE|Comparing baseline-\>12month SBP change within usual care group (null hypothesis no change).|Mean Difference (Net)|-5.59|||<|0.05|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for usual care group (as given in table)|Comparing baseline-\>12month SBP change within usual care group.||||<0.05
91774072|NCT05546476|183429446|SUPERIORITY||Difference in LS Mean|4.11|||=|0.0138|TWO_SIDED|90.0|1.06|7.17|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.17|1.06|=0.0138
91774073|NCT05546476|183429447|SUPERIORITY||Difference in LS Mean|2.35|||=|0.009|TWO_SIDED|90.0|0.72|3.97|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.97|0.72|=0.0090
91774074|NCT05546476|183429447|SUPERIORITY||Difference in LS Mean|0.0|||=|0.4987|TWO_SIDED|90.0|-1.55|1.56|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.56|-1.55|=0.4987
91774075|NCT05546476|183429447|SUPERIORITY||Difference in LS Mean|2.3|||=|0.01|TWO_SIDED|90.0|0.68|3.92|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.92|0.68|=0.0100
91774076|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.43|||=|0.1912|TWO_SIDED|90.0|-0.38|1.24|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.24|-0.38|=0.1912
91774077|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.46|||=|0.1866|TWO_SIDED|90.0|-0.39|1.3|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.30|-0.39|=0.1866
91774078|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.92|||=|0.0349|TWO_SIDED|90.0|0.09|1.75|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.75|0.09|=0.0349
91774079|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.47|||=|0.8754|TWO_SIDED|90.0|-0.2|1.14|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.14|-0.20|=0.8754
91774080|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.38|||=|0.8205|TWO_SIDED|90.0|-0.31|1.08|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.08|-0.31|=0.8205
91774081|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|-0.17|||=|0.3375|TWO_SIDED|90.0|-0.86|0.51|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.51|-0.86|=0.3375
91519987|NCT04575051|182914093|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.96|TWO_SIDED|95.0|-1.2|1.14|||Mixed Models Analysis||Estimated Value represents the difference in the means for the Consult and HearCARE models.|||1.14|-1.20|0.96
91774082|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.66|||=|0.9138|TWO_SIDED|90.0|-0.14|1.45|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.45|-0.14|=0.9138
91774083|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.64|||=|0.9011|TWO_SIDED|90.0|-0.18|1.46|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.46|-0.18|=0.9011
91774084|NCT05546476|183429448|SUPERIORITY||Difference in LS Mean|0.21|||=|0.6618|TWO_SIDED|90.0|-0.61|1.02|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.02|-0.61|=0.6618
91774085|NCT03585660|183429462|SUPERIORITY|||||||0.02|||||||bootstrap z-test|The standard error of the difference in accuracy was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.||||0.02
91774086|NCT03585660|183429463|SUPERIORITY|||||||0.08|||||||bootstrap z-test|The standard error of the difference of AUCs was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.||||0.08
91774087|NCT03585660|183429464|SUPERIORITY|||||||0.97|||||||bootstrap z-test|||The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.||||0.97
91774088|NCT03585660|183429465|SUPERIORITY||||||<|0.01|||||||bootstrap z-test|||The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.||||<0.01
91774089|NCT03585660|183429466|SUPERIORITY|The null hypothesis is that the PPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the PPV of HM-MRI is greater than the PPV of mp-MRI.||||||0.06|||||||bootstrap z-test|||||||0.06
91774090|NCT03585660|183429467|SUPERIORITY|The null hypothesis is that the NPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the NPV of HM-MRI is greater than the NPV of mp-MRI.||||||0.97|||||||bootstrap z-test|||||||0.97
91774091|NCT00910104|183429598|SUPERIORITY||Hazard Ratio (HR)|8.6|||=|0.001|TWO_SIDED|95.0|2.0|37.3||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Crude (unadjusted) hazard ratios were estimated using proportional hazard regression. Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||37.3|2.0|=0.001
91774092|NCT00910104|183429598|SUPERIORITY||Hazard Ratio (HR)|17.4||||0.001|TWO_SIDED|95.0|3.7|83.0||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Adjusted hazard ratios were estimated using proportional hazard regression adjusted for baseline covariates (including duration of parenteral nutrition (PN) and baseline DB). Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||83|3.7|0.001
91774093|NCT00910104|183429598|OTHER||||||<|0.0001|||||||Fisher Exact|||Comparison of proportion with reversal of cholestasis (direct bilirubin \<=2.0 mg/dL).||||<0.0001
91774094|NCT03137654|183429599|SUPERIORITY|||||||0.0078|||||||Linear Mixed Model|||||||.0078
91774095|NCT03137654|183429603|SUPERIORITY|||||||0.393|||||||ANOVA|||||||0.393
91774096|NCT03137654|183429605|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
91774097|NCT03137654|183429606|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
91774098|NCT03137654|183429607|SUPERIORITY|||||||0.0365|||||||ANOVA|||||||0.0365
91519988|NCT04575051|182914094|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.13|TWO_SIDED|95.0|-0.07|0.48|||Mixed Models Analysis||The Estimated Value is the difference between the means of the Consult and HearCARE models.|||0.48|-0.07|0.13
91774099|NCT03137654|183429608|SUPERIORITY|||||||0.212|||||||ANOVA|||||||.212
91774100|NCT03137654|183429609|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91774101|NCT03137654|183429610|SUPERIORITY|||||||0.445|||||||ANOVA|||||||.445
91774102|NCT03137654|183429611|SUPERIORITY|||||||0.245|||||||ANOVA|||||||.245
91774103|NCT04890652|183429612|OTHER|single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
91774104|NCT04890652|183429613|OTHER|Single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
91774105|NCT04386291|183429619|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.071|TWO_SIDED||||||t-test, 1 sided|||||||0.071
91774106|NCT04386291|183429619|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.46|TWO_SIDED||||||t-test, 1 sided|||||||0.46
91774107|NCT04386291|183429620|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.01|TWO_SIDED||||||t-test, 1 sided|||||||0.01
91774108|NCT04386291|183429620|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
91774109|NCT04386291|183429621|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.08|TWO_SIDED||||||t-test, 1 sided|||||||0.08
91774110|NCT04386291|183429621|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.5|TWO_SIDED||||||t-test, 1 sided|||||||0.5
91774111|NCT04386291|183429622|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.25|TWO_SIDED||||||t-test, 1 sided|||||||0.25
91774112|NCT04386291|183429622|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.065|TWO_SIDED||||||t-test, 1 sided|||||||0.065
91774113|NCT04386291|183429623|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.88|TWO_SIDED||||||t-test, 1 sided|||||||0.88
91774114|NCT04386291|183429623|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.7|TWO_SIDED||||||t-test, 1 sided|||||||0.7
91774115|NCT04386291|183429624|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.038|TWO_SIDED||||||t-test, 1 sided|||||||0.038
91774116|NCT04386291|183429624|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.059|TWO_SIDED||||||t-test, 1 sided|||||||0.059
91774117|NCT04386291|183429625|SUPERIORITY||Median Difference (Final Values)|1.58||||0.9|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.9
91774118|NCT04386291|183429625|SUPERIORITY||Mean Difference (Net)|-0.73||||0.23|TWO_SIDED||||||t-test, 1 sided|||Subpression subscale analysis||||0.23
91774119|NCT04386291|183429625|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.7|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.7
91774120|NCT04386291|183429625|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED||||||t-test, 1 sided|||Suppression subscale analysis||||0.5
91774121|NCT04386291|183429626|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5|TWO_SIDED||||||ANOVA|||||||0.5
91774122|NCT04386291|183429627|SUPERIORITY||mean rank difference|79.0||||0.076|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Witney was used because assumption of normality of variance was violated||||||0.076
91774123|NCT04386291|183429627|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.8|TWO_SIDED||||||t-test, 1 sided|||||||0.8
91774124|NCT00772538|183429644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.034||0.011||95.0|0.02|0.152||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.152|0.020|0.0110
91774125|NCT00772538|183429645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.005||95.0|0.027|0.149||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.027|0.0050
91774126|NCT00772538|183429646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
91519989|NCT00951483|182914095|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-2.65||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.||||.001
91774127|NCT00772538|183429647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.043||0.0362||95.0|0.006|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.006|0.0362
91774128|NCT00772538|183429648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.04||0.0007||95.0|0.058|0.214||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.214|0.058|0.0007
91774129|NCT00772538|183429649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.032||0.0067||95.0|0.024|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.024|0.0067
91774130|NCT00772538|183429650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.04||0.0139||95.0|0.02|0.176||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.176|0.020|0.0139
91774131|NCT00772538|183429651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.034||0.0347||95.0|0.005|0.14||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|0.005|0.0347
91774132|NCT00772538|183429652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.032||0.1896||95.0|-0.021|0.104||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.104|-0.021|0.1896
91519990|NCT00951483|182914096|SUPERIORITY_OR_OTHER||z-score|-4.544|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.||||<.001
91774133|NCT00772538|183429653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.032||0.0247||95.0|0.009|0.136||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.136|0.009|0.0247
91774134|NCT00772538|183429654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.043||0.0039||95.0|0.04|0.21||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.210|0.040|0.0039
91774135|NCT00772538|183429655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.19||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.190|0.031|0.0063
91774136|NCT00772538|183429656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.041||0.0027||95.0|0.042|0.201||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.201|0.042|0.0027
91774137|NCT00772538|183429657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.293|STANDARD_ERROR_OF_MEAN|4.584|<|0.0001||95.0|13.279|31.308||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||31.308|13.279|<0.0001
91774138|NCT00772538|183429658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.267|STANDARD_ERROR_OF_MEAN|4.699|<|0.0001||95.0|14.027|32.507||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||32.507|14.027|<0.0001
91774139|NCT00772538|183429659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.061|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.061|<0.0001
91774140|NCT00772538|183429660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.068|0.181||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.181|0.068|<0.0001
91774141|NCT00772538|183429661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.736||0.7012||95.0|-1.165|1.731||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||1.731|-1.165|0.7012
91774142|NCT00772538|183429662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0499||95.0|0.49|1.0||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.00|0.49|0.0499
91774143|NCT00772538|183429663|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71|STANDARD_ERROR_OF_MEAN|0.09||0.0102||95.0|0.55|0.92||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.92|0.55|0.0102
91774144|NCT00772538|183429664|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.1||0.0062||95.0|0.46|0.88||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.88|0.46|0.0062
91774145|NCT00772538|183429665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0065||95.0|0.4|0.88||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.88|0.40|0.0065
91774146|NCT00772538|183429666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.0561||95.0|0.42|1.01||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.01|0.42|0.0561
91774147|NCT00772538|183429667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.5604||95.0|0.3|1.92||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium|||1.92|0.30|0.5604
91774148|NCT00772538|183429668|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.5538||95.0|0.54|1.39||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.39|0.54|0.5538
91774149|NCT00772538|183429669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.633||95.0|0.25|2.13||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.13|0.25|0.6330
91774150|NCT00772538|183429670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.074||0.5714||95.0|-0.103|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|-0.103|0.5714
91774151|NCT00772538|183429671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.075||0.6099||95.0|-0.109|0.185||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.185|-0.109|0.6099
91774152|NCT00772538|183429672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0586||95.0|-0.256|0.005||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.005|-0.256|0.0586
91774153|NCT00772538|183429673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.067||0.0727||95.0|-0.253|0.011||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.011|-0.253|0.0727
91774154|NCT00772538|183429674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.024||0.9807||95.0|-0.048|0.047||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.047|-0.048|0.9807
91774155|NCT00772538|183429675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.172||0.5927||95.0|-0.43|0.246||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.246|-0.430|0.5927
91774156|NCT00772538|183429676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
91774157|NCT00772538|183429676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
91774158|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.692||||||For ILC|ANCOVA|||||||0.692
91774159|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.467||||||For ILC|ANCOVA|||||||0.467
91774160|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.281||||||For ILC|ANCOVA|||||||0.281
91774161|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.075||||||For ILC|ANCOVA|||||||0.075
91774162|NCT00713609|183429684|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
91774163|NCT00713609|183429684|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
91774164|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.803||||||For NILC|ANCOVA|||||||0.803
91774165|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.175||||||For NILC|ANCOVA|||||||0.175
91774166|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.552||||||For NILC|ANCOVA|||||||0.552
91774167|NCT00713609|183429684|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
91774168|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
91774169|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.618||||||For TC|ANCOVA|||||||0.618
91774170|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.149||||||For TC|ANCOVA|||||||0.149
91774171|NCT00713609|183429684|SUPERIORITY_OR_OTHER|||||||0.255||||||For TC|ANCOVA|||||||0.255
91774172|NCT00713609|183429684|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
91774173|NCT00713609|183429685|SUPERIORITY_OR_OTHER|||||||0.922|||||||Cochran-Mantel-Haenszel|||||||0.922
91774174|NCT00713609|183429685|SUPERIORITY_OR_OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
91774175|NCT00713609|183429685|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
91774176|NCT00713609|183429685|SUPERIORITY_OR_OTHER|||||||0.706|||||||Cochran-Mantel-Haenszel|||||||0.706
91774177|NCT00713609|183429685|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||||||0.009
91774178|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
91774179|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
91774180|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.177||||||For ILC|ANCOVA|||||||0.177
91774181|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.084||||||For ILC|ANCOVA|||||||0.084
91774182|NCT00713609|183429686|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
91774183|NCT00713609|183429686|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
91774184|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.776||||||For NILC|ANCOVA|||||||0.776
91774185|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.465||||||For NILC|ANCOVA|||||||0.465
91774186|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.288||||||For NILC|ANCOVA|||||||0.288
91774187|NCT00713609|183429686|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
91774188|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
91774189|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.62||||||For TC|ANCOVA|||||||0.620
91774190|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.291||||||For TC|ANCOVA|||||||0.291
91774191|NCT00713609|183429686|SUPERIORITY_OR_OTHER|||||||0.085||||||For TC|ANCOVA|||||||0.085
91774192|NCT00713609|183429686|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
91774193|NCT00713609|183429687|SUPERIORITY_OR_OTHER|||||||0.652|||||||Cochran-Mantel-Haenszel|||||||0.652
91774194|NCT00713609|183429687|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|||||||0.279
91774195|NCT00713609|183429687|SUPERIORITY_OR_OTHER|||||||0.312|||||||Cochran-Mantel-Haenszel|||||||0.312
91774196|NCT00713609|183429687|SUPERIORITY_OR_OTHER|||||||0.063|||||||Cochran-Mantel-Haenszel|||||||0.063
91774197|NCT00713609|183429687|SUPERIORITY_OR_OTHER|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
91774198|NCT01903356|183429688|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.|The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration|||<0.0001
91774199|NCT01903356|183429691|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment|The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration|||<0.0001
91774200|NCT04529083|183429693|OTHER||Mean Difference (Net)|-0.625||||0.011|TWO_SIDED|95.0|-1.06|-0.19|||t-test, 2 sided|||||-0.19|-1.06|0.011
91774201|NCT04529083|183429695|SUPERIORITY||Mean Difference (Net)|1.94||||0.006|TWO_SIDED|95.0|0.63|3.26|||t-test, 2 sided|||||3.26|0.63|0.006
91519991|NCT00951483|182914097|SUPERIORITY_OR_OTHER||z-score|-4.627|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.||||<.001
91774202|NCT03305666|183429701|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||||||0.12
91774203|NCT03305666|183429702|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.41|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #1.||||0.41
91774204|NCT03305666|183429702|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.25|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #2.||||0.25
91774205|NCT03305666|183429702|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #3.||||0.12
91774206|NCT03305666|183429702|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.04|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #4.||||0.04
91774207|NCT03305666|183429702|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.32|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #5.||||0.32
91774208|NCT03305666|183429703|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.23|||||||ANOVA|||||||0.23
91774209|NCT04196686|183429704|OTHER||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.25|0.51|||Cox mixed effects model|||||0.51|0.25|<0.001
91774210|NCT04196686|183429705|OTHER||Mean Difference (Net)|0.455||||0.2|TWO_SIDED|95.0|0.32|0.59|||Linear mixed effects model|||Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.||0.59|0.32|0.200
91774211|NCT04196686|183429706|OTHER||Mean Difference (Net)|0.002||||0.047|TWO_SIDED|95.0|0.00007|0.00368|||Linear mixed effects model|||The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.||0.00368|0.00007|0.047
91774212|NCT03448406|183429777|SUPERIORITY||Median difference (HL-estimate)|4.0||||0.366|TWO_SIDED|95.0|-5.0|13.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||13.0|-5.0|0.3660
91774213|NCT03448406|183429778|SUPERIORITY||Median difference (HL-estimate)|2.08||||0.2783|TWO_SIDED|95.0|-2.08|6.25|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||6.25|-2.08|0.2783
91774214|NCT03448406|183429779|SUPERIORITY||Median difference (HL-estimate)|-0.07||||0.5512|TWO_SIDED|95.0|-0.35|0.2|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||0.20|-0.35|0.5512
91774215|NCT03448406|183429780|SUPERIORITY||Median Difference (HL-estimate)|3.0||||0.3657|TWO_SIDED|95.0|-4.0|11.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||11.0|-4.0|0.3657
91774216|NCT03448406|183429781|OTHER||Difference of adjusted mean|-0.09|STANDARD_DEVIATION|0.11||0.444|TWO_SIDED|95.0|-0.31|0.14|||Mixed Model Repeated Measure (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||0.14|-0.31|0.4440
91774217|NCT03448406|183429782|OTHER|||||||0.3924|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.3924
91519992|NCT00951483|182914098|SUPERIORITY_OR_OTHER||z-score|-4.624|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.||||<.001
91774218|NCT03448406|183429783|OTHER|||||||0.4435|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.4435
91774219|NCT03448406|183429784|OTHER|||||||0.5124|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5124
91774220|NCT03448406|183429785|OTHER|||||||0.5713|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5713
91774221|NCT03448406|183429786|OTHER||Adjusted geometric mean ratio|0.95||||0.4032|TWO_SIDED|95.0|0.85|1.07|||Mixed model repeated Measure (MMRM)|Covariates: Visit-by-treatment interaction and baseline-by-visit interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|||1.07|0.85|0.4032
91774222|NCT01292486|183429787|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 2 days.|Median Difference (Final Values)|0.0|||<|0.025|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehman estimation|||The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.||0.0|0.0|<0.025
91774223|NCT04369404|183429797|SUPERIORITY|We hypothesize that participants who received the decision aid will have higher knowledge. This is pilot study, thus we did not have a power calculation.|Mean Difference (Final Values)|12.0||||0.06|TWO_SIDED|95.0|0.7|24.6|||t-test, 2 sided|||||24.6|0.7|0.06
91774224|NCT04369404|183429798|OTHER||Pearson Chi-Square|2.97||||0.085|TWO_SIDED||||||Chi-squared|||"a chisquare test was conducted to determine if the proportion of treatment unsure responses were different between the usual care and intervention arms."||||0.085
91774225|NCT04369404|183429799|OTHER||Pearson Chi-Square|1.524||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
91774226|NCT01210716|183429813|NON_INFERIORITY_OR_EQUIVALENCE|If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value \<=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%.|Mean Difference (Final Values)|6.69|STANDARD_DEVIATION|6.97|<|0.001|ONE_SIDED|95.0|4.0||||paired t-test|||A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.|||4.0|<0.001
91774227|NCT01791244|183429820|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.9148|TWO_SIDED|95.0|-8.3|9.25|||linear mixed model|||Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.||9.25|-8.30|0.9148
91774228|NCT01856270|183429843|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.114||||0.101|ONE_SIDED|95.0|-0.017|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.|||-0.017|.101
91774229|NCT01856270|183429844|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.194||||0.017|ONE_SIDED|95.0|0.057|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain \>=6.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening|||.057|.017
91774230|NCT01856270|183429845|SUPERIORITY||Difference of proportions|0.093||||0.456|TWO_SIDED|95.0|-0.106|0.286||A priori significance threshold α=.05|Fisher Exact||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).|||.286|-.106|.456
91774231|NCT01856270|183429846|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.684|TWO_SIDED|95.0|-5.1|3.4||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||3.4|-5.1|.684
91774232|NCT01856270|183429847|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.306|TWO_SIDED|95.0|-1.0|2.9||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||2.9|-1.0|.306
91774233|NCT01856270|183429848|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.583|TWO_SIDED|95.0|-0.9|1.6||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||1.6|-0.9|.583
91774234|NCT01856270|183429849|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.444|TWO_SIDED|95.0|-4.0|8.8||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||8.8|-4.0|.444
91774235|NCT01856270|183429850|SUPERIORITY||Mean Difference (Final Values)|27.3||||0.041|TWO_SIDED|95.0|1.2|53.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||53.3|1.2|.041
91774236|NCT01856270|183429851|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.089|TWO_SIDED|95.0|-3.8|0.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||0.3|-3.8|.089
91774237|NCT03535974|183429879|OTHER||Mean Difference (Final Values)|10.57|STANDARD_ERROR_OF_MEAN|5.122||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
91774238|NCT02913482|183429934|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
91519993|NCT00951483|182914099|SUPERIORITY_OR_OTHER||z-score|-4.51|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.||||<.001
91519994|NCT00951483|182914100|SUPERIORITY_OR_OTHER||z-score|-4.435|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.||||<.001
91774239|NCT02913482|183429935|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
91774240|NCT02913482|183429936|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
91774241|NCT02913482|183429942|SUPERIORITY|Result compared to a performance criterion of 12% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
91774242|NCT02913482|183429944|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
91774243|NCT02913482|183429945|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
91774244|NCT02913482|183429946|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
91774245|NCT02913482|183429947|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
91774246|NCT02913482|183429951|SUPERIORITY|Result compared to a performance criterion of 42% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Z-test|||||||<0.0001
91774247|NCT02913482|183429952|SUPERIORITY|Result compared to a performance criterion of 60% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.0005|||||||One-sided Z-test|||||||0.0005
91774248|NCT02913482|183429953|SUPERIORITY|Result compared to a performance criterion of 89% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.2595|||||||One-sided Z-test|||||||0.2595
91774249|NCT01983228|183429996|SUPERIORITY||Odds Ratio (OR)|1.61||||0.09|TWO_SIDED|95.0|0.94|2.77||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.77|0.94|0.09
91774250|NCT01983228|183429997|SUPERIORITY||Median Difference (Final Values)|-0.2||||0.34|TWO_SIDED|95.0|-0.62|0.21||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.21|-0.62|0.34
91774251|NCT01983228|183429998|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.38|TWO_SIDED|95.0|-1.69|0.65||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.65|-1.69|0.38
91774252|NCT01983228|183429999|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.28|TWO_SIDED|95.0|-1.68|0.49||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.49|-1.68|0.28
91774253|NCT01983228|183430000|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED|95.0|0.0|0.77||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.77|-0.00|0.05
91774254|NCT01983228|183430001|SUPERIORITY|Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Mean Difference (Final Values)|193.9||||0.56|TWO_SIDED|95.0|-454.93|842.73||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||842.73|-454.93|0.56
91774255|NCT01983228|183430002|SUPERIORITY||Odds Ratio (OR)|1.49||||0.16|TWO_SIDED|95.0|0.85|2.62||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.62|0.85|0.16
91774256|NCT01983228|183430003|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.002|TWO_SIDED|95.0|-0.99|-0.23||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.23|-0.99|0.002
91774257|NCT01983228|183430004|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.54|TWO_SIDED|95.0|-0.79|1.51||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.51|-0.79|0.54
91519995|NCT00951483|182914101|SUPERIORITY_OR_OTHER||z-score|-3.911|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.||||<.001
91774258|NCT01983228|183430005|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|95.0|-0.66|1.62||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.62|-0.66|0.41
91774259|NCT01983228|183430006|SUPERIORITY||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.38|-1.07|<0.0001
91774260|NCT01983228|183430007|SUPERIORITY||Mean Difference (Final Values)|540.78||||0.06|TWO_SIDED|95.0|-28.77|1110.33||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1110.33|-28.77|0.06
91774261|NCT01983228|183430008|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.05|TWO_SIDED|95.0|-0.01|5.86||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||5.86|-0.01|0.05
91774262|NCT01983228|183430009|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.01|TWO_SIDED|95.0|0.15|1.36||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.36|0.15|0.01
91774263|NCT01983228|183430010|SUPERIORITY||Mean Difference (Final Values)|-1.07||||0.15|TWO_SIDED|95.0|-2.53|0.39||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.39|-2.53|0.15
91774264|NCT01983228|183430011|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.56|TWO_SIDED|95.0|-0.8|1.47||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.47|-0.80|0.56
91774265|NCT01983228|183430012|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.38|TWO_SIDED|95.0|-0.17|0.46||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.46|-0.17|0.38
91774266|NCT01983228|183430013|SUPERIORITY||Odds Ratio (OR)|1.2||||0.56|TWO_SIDED|95.0|0.66|2.19||Logistic regression modeling the odds of yes to using opioids for pain treatment adjusting for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||||2.19|0.66|0.56
91774267|NCT01983228|183430014|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.18|0.84||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.84|-0.18|0.21
91774268|NCT01650558|183430028|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.27|||<=|0.05|TWO_SIDED|95.0|0.89|1.82||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.82|0.89|<=0.05
91646104|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.5169|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.5169
91774269|NCT01650558|183430028|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.28|||<=|0.05|TWO_SIDED|95.0|0.89|1.83||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.83|0.89|<=0.05
91774270|NCT01650558|183430029|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.38|||<=|0.05|TWO_SIDED|95.0|0.83|2.3||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.30|0.83|<=0.05
91774271|NCT01650558|183430029|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.51|||<=|0.05|TWO_SIDED|95.0|0.91|2.49||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.49|0.91|<=0.05
91774272|NCT01650558|183430030|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.13|||<=|0.05|TWO_SIDED|95.0|0.66|1.93||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.93|0.66|<=0.05
91774273|NCT01650558|183430030|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|0.96|||<=|0.05|TWO_SIDED|95.0|0.55|1.68||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.68|0.55|<=0.05
91774274|NCT01650558|183430031|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.47|||<=|0.05|TWO_SIDED|95.0|1.07|2.0||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||2.00|1.07|<=0.05
91774275|NCT01650558|183430031|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.43|||<=|0.05|TWO_SIDED|95.0|1.04|1.96||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.96|1.04|<=0.05
91774276|NCT01650558|183430032|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.31|||<=|0.05|TWO_SIDED|95.0|1.11|1.55||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.55|1.11|<=0.05
91774277|NCT01650558|183430032|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.34|||<=|0.05|TWO_SIDED|95.0|1.14|1.58||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.58|1.14|<=0.05
91613885|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.738||||0.0039|TWO_SIDED|95.0|1.194|2.528|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|1.194|0.0039
91774278|NCT02960217|183430036|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|1.46||||0.2684|TWO_SIDED|95.0|-1.12|4.36||Hodges-Lehmann estimate of the location shift with 95% confidence interval (CI) and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Participants completing both UX007 treatment period and placebo period (n=42). Per protocol, when the normality assumption is not met (p value for Wilk-Shapiro test \< 0.05), Wilcoxon rank-sum test will be considered as the primary analysis to assess treatment difference in movement disorder event frequency.||4.36|-1.12|0.2684
91774279|NCT02960217|183430036|SUPERIORITY||||||<|0.0001|||||||Wilk-Shapiro test for normality|||||||< 0.0001
91774280|NCT02960217|183430039|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|25.0||||0.6419|TWO_SIDED|95.0|-62.5|91.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=34).||91.5|-62.5|0.6419
91774281|NCT02960217|183430039|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
91774282|NCT02960217|183430040|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.9513|TWO_SIDED|95.0|-2.0|1.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.9|-2.0|0.9513
91774283|NCT02960217|183430040|SUPERIORITY|||||||0.8214|||||||Wilk-Shapiro Test for Normality|||||||0.8214
91774284|NCT02960217|183430041|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.32||0.1572|TWO_SIDED|95.0|-0.8|4.7||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.7|-0.8|0.1572
91774285|NCT02960217|183430041|SUPERIORITY|||||||0.8451|||||||Wilk-Shapiro Test for Normality|||||||0.8451
91774286|NCT02960217|183430042|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.66||0.8345|TWO_SIDED|95.0|-3.8|3.1||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.1|-3.8|0.8345
91774287|NCT02960217|183430042|SUPERIORITY|||||||0.2894|||||||Wilk-Shapiro Test for Normality|||||||0.2894
91774288|NCT02960217|183430043|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
91774289|NCT02960217|183430043|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.2||||0.4898|TWO_SIDED|95.0|-5.4|5.8||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=21).||5.8|-5.4|0.4898
91774290|NCT02960217|183430044|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.42||0.5853|TWO_SIDED|95.0|-2.2|3.8||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.8|-2.2|0.5853
91774291|NCT02960217|183430044|SUPERIORITY|||||||0.1066|||||||Wilk-Shapiro Test for Normality|||||||0.1066
91774292|NCT02960217|183430045|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.33||0.1875|TWO_SIDED|95.0|-4.6|1.0||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.0|-4.6|0.1875
91774293|NCT02960217|183430045|SUPERIORITY|||||||0.2034|||||||Wilk-Shapiro Test for Normality|||||||0.2034
91774294|NCT02960217|183430046|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.56||0.1138|TWO_SIDED|95.0|-0.7|5.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.9|-0.7|0.1138
91774295|NCT02960217|183430046|SUPERIORITY|||||||0.1478|||||||Wilk-Shapiro Test for Normality|||||||0.1478
91774296|NCT02960217|183430047|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.62||0.5505|TWO_SIDED|95.0|-4.6|2.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||2.6|-4.6|0.5505
91774297|NCT02960217|183430047|SUPERIORITY|||||||0.4459|||||||Wilk-Shapiro Test for Normality|||||||0.4459
91774298|NCT02960217|183430048|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.84||0.5544|TWO_SIDED|95.0|-8.1|4.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.6|-8.1|0.5544
91774299|NCT02960217|183430048|SUPERIORITY|||||||0.1104|||||||Wilk-Shapiro Test for Normality|||||||0.1104
91774300|NCT02960217|183430049|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|3.27||0.7145|TWO_SIDED|95.0|-8.5|6.1|||ANCOVA|||||6.1|-8.5|0.7145
91774301|NCT02960217|183430049|SUPERIORITY|||||||0.8255|||||||Wilk-Shapiro Test for Normality|||||||0.8255
91774302|NCT02960217|183430050|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.82||0.4176|TWO_SIDED|95.0|-2.5|5.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.6|-2.5|0.4176
91774303|NCT02960217|183430050|SUPERIORITY|||||||0.6557|||||||Wilk-Shapiro Test for Normality|||||||0.6557
91774304|NCT02960217|183430051|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.09||0.0935|TWO_SIDED|95.0|-0.4|4.5||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.5|-0.4|0.0935
91774305|NCT02960217|183430051|SUPERIORITY|||||||0.7267|||||||Wilk-Shapiro Test for Normality|||||||0.7267
91774306|NCT02960217|183430052|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8329|TWO_SIDED|95.0|-0.6|0.5||Based on an ANCOVA model including covariate for study baseline CGI-S score, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||0.5|-0.6|0.8329
91774307|NCT02960217|183430052|SUPERIORITY|||||||0.2348|||||||Wilk-Shapiro Test for Normality|||||||0.2348
91774308|NCT02960217|183430054|SUPERIORITY|||||||0.0315|||||||Wilk-Shapiro Test for Normality|||||||0.0315
91774309|NCT02960217|183430054|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|-0.5||||0.2425|TWO_SIDED|95.0|-1.5|0.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||0.5|-1.5|0.2425
91774310|NCT02960217|183430055|SUPERIORITY|||||||0.0072|||||||Wilk-Shapiro Test for Normality|||||||0.0072
91774311|NCT02960217|183430055|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.0||||1|TWO_SIDED|95.0|-14.5|13.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=12).||13.5|-14.5|1.0000
91774312|NCT02960217|183430056|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.1076|TWO_SIDED|95.0|-0.3|2.2||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.2|-0.3|0.1076
91774313|NCT02960217|183430056|SUPERIORITY|||||||0.7698|||||||Wilk-Shapiro Test for Normality|||||||0.7698
91774314|NCT02960217|183430057|SUPERIORITY|||||||0.0138|||||||Wilk-Shapiro Test for Normality|||||||0.0138
91774315|NCT02960217|183430057|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|2.0||||0.3907|TWO_SIDED|95.0|-3.5|20.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||20.5|-3.5|0.3907
91774316|NCT02960217|183430058|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.5233|TWO_SIDED|95.0|-4.4|2.4||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.4|-4.4|0.5233
91774317|NCT02960217|183430058|SUPERIORITY|||||||0.6918|||||||Wilk-Shapiro Test for Normality|||||||0.6918
91774318|NCT02734693|183430059|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-7.565|-2.802|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol.||-2.802|-7.565|<0.001
91774319|NCT02734693|183430062|SUPERIORITY||Mean Difference (Final Values)|23.67|STANDARD_ERROR_OF_MEAN|7.395||0.002|TWO_SIDED|95.0|8.987|38.346|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.346|8.987|0.002
91774320|NCT02734693|183430062|SUPERIORITY||Mean Difference (Net)|24.05|STANDARD_ERROR_OF_MEAN|7.389||0.002|TWO_SIDED|95.0|9.381|38.714|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.714|9.381|0.002
91774321|NCT02649556|183430086|OTHER||LS Mean Difference|1.75|||||TWO_SIDED|95.0|-0.16|3.65||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|3.65|-0.160|
91774322|NCT02649556|183430087|OTHER||LS Mean Difference|-0.413|||||TWO_SIDED|95.0|-0.694|-0.131||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of White Blood Cell counts between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|-0.131|-0.694|
91774323|NCT02649556|183430088|OTHER||LS Mean Difference|0.914|||||TWO_SIDED|95.0|-0.339|2.17||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of FEV1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|2.17|-0.339|
91774324|NCT02649556|183430089|OTHER||% Relative Reduction|3.11|||||TWO_SIDED|95.0|0.0231|6.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of sICAM-1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|6.10|0.0231|
91707977|NCT03224624|183309105|EQUIVALENCE|Comparing baseline-\>12month DBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-5.51|||<|0.01|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for self-management group (as given in table)|change in DBP from baseline to 12-months within self-management group.||||<0.01
91707978|NCT03224624|183309105|EQUIVALENCE|change in DBP from baseline to 12-months within usual care group.|Mean Difference (Net)|-1.76||||0.34|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for usual care group (as given in table)|||||0.34
91707979|NCT02488018|183309115|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||ANOVA|Degree of freedom for the model (treatment) was 8.||Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.||||<0.01
91707980|NCT00482170|183309116|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.87|1.77||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.77|0.87|<0.001
91707981|NCT00482170|183309117|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.95|1.87||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.87|0.95|<0.001
91707982|NCT00482170|183309118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.12||||0.008|TWO_SIDED|95.0|2.05|126.9||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||126.9|2.05|0.008
91707983|NCT00482170|183309118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.25||||0.002|TWO_SIDED|95.0|2.44|51.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||51.83|2.44|0.002
91707984|NCT00482170|183309118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88||||0.001|TWO_SIDED|95.0|2.26|27.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||27.44|2.26|0.001
91707985|NCT00482170|183309118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.73|||<|0.001|TWO_SIDED|95.0|2.59|29.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used for the analysis.||29.47|2.59|<0.001
91774325|NCT02649556|183430090|OTHER||% Relative Reduction|3.44|||||TWO_SIDED|95.0|-8.74|14.3|||||Derived as 100 x (1-Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 11-DTXB2 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|14.3|-8.74|
91707986|NCT00482170|183309119|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.045|TWO_SIDED|95.0|0.0|0.34||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.34|0.00|0.045
91707987|NCT00482170|183309120|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.707|TWO_SIDED|95.0|-0.58|0.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, female and male (reference).||0.39|-0.58|0.707
91707988|NCT00482170|183309121|SUPERIORITY_OR_OTHER||Regression coefficient|-0.38||||0.195|TWO_SIDED|95.0|-0.89|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).||0.14|-0.89|0.195
91707989|NCT00482170|183309121|SUPERIORITY_OR_OTHER||Regression coefficient|-0.55||||0.195|TWO_SIDED|95.0|-1.21|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).||0.11|-1.21|0.195
91707990|NCT00482170|183309122|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.493|TWO_SIDED|95.0|-0.36|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-A: =\< 4, HAD-A: \> 4 to 7, HAD-A: \> 7 to 10 and HAD-A: \> 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.36|0.493
91707991|NCT00482170|183309122|SUPERIORITY_OR_OTHER||Regression coefficient|-0.16||||0.287|TWO_SIDED|95.0|-0.46|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-D: =\< 3, HAD-D: \> 3 to 5, HAD-D: \> 5 to 8 and HAD-A: \> 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.14|-0.46|0.287
91707992|NCT00482170|183309123|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.123|TWO_SIDED|95.0|-0.04|0.3||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.30|-0.04|0.123
91707993|NCT00482170|183309124|SUPERIORITY_OR_OTHER||Regression coefficient|-0.24||||0.359|TWO_SIDED|95.0|-0.76|0.28||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.28|-0.76|0.359
91774326|NCT02649556|183430091|OTHER||% Relative Reduction|7.15|||||TWO_SIDED|95.0|-1.03|14.7|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 8-epi-PGF2α levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|14.7|-1.03|
91774327|NCT02649556|183430092|OTHER||% Relative Reduction|46.3|||||TWO_SIDED|95.0|36.2|54.8|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of Total NNAL levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|54.8|36.2|
91774328|NCT02649556|183430093|OTHER||% Relative Reduction|31.7|||||TWO_SIDED|95.0|23.3|39.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of COHb levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|39.1|23.3|
91774329|NCT01766050|183430094|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
91774330|NCT01766050|183430094|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
91774331|NCT01766050|183430094|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
91774332|NCT01766050|183430112|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.976|1.13||||||AUC (0-T)||1.130|0.976|
91774333|NCT01766050|183430112|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.966|||||TWO_SIDED|90.0|0.889|1.049||||||AUC (0-T)||1.049|0.889|
91774334|NCT01766050|183430112|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.033|||||TWO_SIDED|90.0|0.95|1.123||||||AUC (0-T)||1.123|0.950|
91774335|NCT01766050|183430112|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.049|||||TWO_SIDED|90.0|0.975|1.127||||||AUC (INF)||1.127|0.975|
91774336|NCT01766050|183430112|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.968|||||TWO_SIDED|90.0|0.892|1.049||||||AUC (INF)||1.049|0.892|
91774337|NCT01766050|183430112|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.948|1.121||||||AUC(INF)||1.121|0.948|
91774338|NCT01766050|183430113|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
91774339|NCT01766050|183430113|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
91774340|NCT01766050|183430113|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
91774341|NCT01766050|183430114|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.013|||||TWO_SIDED|90.0|0.944|1.088||||||AUC (0-T)||1.088|0.944|
91774342|NCT01766050|183430114|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.936|1.103||||||AUC (0-T)||1.103|0.936|
91774343|NCT01766050|183430114|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.001|||||TWO_SIDED|90.0|0.893|1.121||||||AUC (0-T)||1.121|0.893|
91774344|NCT01766050|183430114|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.011|||||TWO_SIDED|90.0|0.942|1.085||||||AUC (INF)||1.085|0.942|
91774345|NCT01766050|183430114|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.938|1.101||||||AUC (INF)||1.101|0.938|
91774346|NCT01766050|183430114|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.896|1.121||||||AUC (INF)||1.121|0.896|
91774347|NCT01766050|183430115|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.26|||||TWO_SIDED|90.0|1.118|1.421||||||||1.421|1.118|
91774348|NCT01766050|183430115|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.292|||||TWO_SIDED|90.0|1.09|1.531||||||||1.531|1.090|
91774349|NCT01766050|183430115|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.178|||||TWO_SIDED|90.0|0.971|1.429||||||||1.429|0.971|
91774350|NCT01766050|183430116|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.159|||||TWO_SIDED|90.0|1.056|1.272||||||AUC (0-T)||1.272|1.056|
91774351|NCT01766050|183430116|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.228|||||TWO_SIDED|90.0|1.092|1.381||||||AUC (0-T)||1.381|1.092|
91774352|NCT01766050|183430116|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.215|||||TWO_SIDED|90.0|1.047|1.41||||||AUC (0-T)||1.410|1.047|
91774353|NCT01766050|183430116|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.193|||||TWO_SIDED|90.0|1.091|1.304||||||AUC (INF)||1.304|1.091|
91774354|NCT01766050|183430116|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.227|||||TWO_SIDED|90.0|1.093|1.379||||||AUC (INF)||1.379|1.093|
91774355|NCT01766050|183430116|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.3|||||TWO_SIDED|90.0|1.141|1.482||||||AUC (INF)||1.482|1.141|
91774356|NCT01766050|183430117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.746|0.997||||||||0.997|0.746|
91774357|NCT01766050|183430117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.793|1.071||||||||1.071|0.793|
91774358|NCT01766050|183430117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.709|1.034||||||||1.034|0.709|
91774359|NCT01766050|183430118|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.915|||||TWO_SIDED|90.0|0.817|1.024||||||AUC (0-T)||1.024|0.817|
91707994|NCT00482170|183309125|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.693|TWO_SIDED|95.0|-0.08|0.12|||Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.12|-0.08|0.693
91707995|NCT00482170|183309126|SUPERIORITY_OR_OTHER||Regression coefficient|0.22||||0.17|TWO_SIDED|95.0|-0.09|0.53||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.53|-0.09|0.170
91707996|NCT00482170|183309127|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.211|TWO_SIDED|95.0|-0.01|0.04||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.04|-0.01|0.211
91707997|NCT00482170|183309128|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.045|TWO_SIDED|95.0|0.0|0.18||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.18|0.00|0.045
91707998|NCT00482170|183309129|SUPERIORITY_OR_OTHER||Regression coefficient|-0.01||||0.913|TWO_SIDED|95.0|-0.12|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.11|-0.12|0.913
91707999|NCT00482170|183309130|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.968|TWO_SIDED|95.0|-0.17|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.17|0.968
91708000|NCT00482170|183309131|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.531|TWO_SIDED|95.0|-0.61|0.32||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).||0.32|-0.61|0.531
91708001|NCT00482170|183309131|SUPERIORITY_OR_OTHER||Regression coefficient|0.44||||0.061|TWO_SIDED|95.0|-0.02|0.9||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).||0.90|-0.02|0.061
91708002|NCT00482170|183309132|SUPERIORITY_OR_OTHER||Regression coefficient|-0.73||||0.759|TWO_SIDED|95.0|-5.37|3.92||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||3.92|-5.37|0.759
91708003|NCT00482170|183309133|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.713|TWO_SIDED|95.0|-0.37|0.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.55|-0.37|0.713
91774360|NCT01766050|183430118|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.003|||||TWO_SIDED|90.0|0.856|1.175||||||AUC (0-T)||1.175|0.856|
91708004|NCT00482170|183309134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.63|3.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.49|1.63|<0.001
91708005|NCT00482170|183309134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.61|3.67||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.67|1.61|<0.001
91708006|NCT00482170|183309134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.001|TWO_SIDED|95.0|1.78|4.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.21|1.78|<0.001
91708007|NCT00482170|183309134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.66|3.8||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.80|1.66|<0.001
91708008|NCT00482170|183309135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.004|TWO_SIDED|95.0|1.22|2.89||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.89|1.22|0.004
91708009|NCT00482170|183309135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.017|TWO_SIDED|95.0|1.1|2.72||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.72|1.10|0.017
91708010|NCT00482170|183309135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.47|3.73||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.73|1.47|<0.001
91774361|NCT01766050|183430118|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.821|1.13||||||AUC (0-T)||1.130|0.821|
91708011|NCT00482170|183309135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.001|TWO_SIDED|95.0|1.32|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.21|1.32|0.001
91708012|NCT00482170|183309136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.025|TWO_SIDED|95.0|1.07|2.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.64|1.07|0.025
91613886|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.565||||0.0035|TWO_SIDED|95.0|0.386|0.829|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.829|0.386|0.0035
91774362|NCT01766050|183430118|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.877|||||TWO_SIDED|90.0|0.783|0.982||||||AUC (INF)||0.982|0.783|
91774363|NCT01766050|183430118|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.885|1.2||||||AUC (INF)||1.200|0.885|
91774364|NCT01766050|183430118|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.022|||||TWO_SIDED|90.0|0.839|1.245||||||AUC (INF)||1.245|0.839|
91774365|NCT01766050|183430119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.948|||||TWO_SIDED|90.0|0.88|1.021||||||||1.021|0.880|
91774366|NCT01766050|183430119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.857|0.993||||||||0.993|0.857|
91774367|NCT01766050|183430119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.954|||||TWO_SIDED|90.0|0.885|1.028||||||||1.028|0.885|
91774368|NCT01766050|183430120|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.941|||||TWO_SIDED|90.0|0.874|1.013||||||AUC (0-T)||1.013|0.874|
91774369|NCT01766050|183430120|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.986|||||TWO_SIDED|90.0|0.902|1.076||||||AUC (0-T)||1.076|0.902|
91774370|NCT01766050|183430120|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.942|1.12||||||AUC (0-T)||1.120|0.942|
91774371|NCT01766050|183430120|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.939|||||TWO_SIDED|90.0|0.868|1.017||||||AUC (INF)||1.017|0.868|
91774372|NCT01766050|183430120|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.914|1.098||||||||1.098|0.914|
91774373|NCT01766050|183430120|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.036|||||TWO_SIDED|90.0|0.94|1.142||||||AUC (INF)||1.142|0.940|
91774374|NCT01097668|183430131|SUPERIORITY_OR_OTHER||||||<|0.001|||||||negative binomial model|||Comparison of the baseline 'ITT population' MRI data with week 16 data.||||<0.001
91774375|NCT01097668|183430131|SUPERIORITY_OR_OTHER|||||||0.03|||||||negative binomial model|||Comparison of the baseline 'MRI population' data with data from week 16.||||0.030
91774376|NCT02421172|183430138|SUPERIORITY_OR_OTHER_LEGACY||Posterior probablility|0.9729||||||||||||||||||
91774377|NCT02670811|183430152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
91774378|NCT02670811|183430152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.|t-test, 2 sided|||||||<0.05
91774379|NCT02670811|183430153|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
91774380|NCT02670811|183430154|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
91774381|NCT02670811|183430155|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
91774382|NCT02670811|183430156|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
91774383|NCT02670811|183430157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
91774384|NCT04516746|183430169|SUPERIORITY||Vaccine efficacy|73.98|||<|0.001|TWO_SIDED|95.0|65.34|80.47|||Poisson regression with robust variance|||The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.47|65.34|<0.001
91774385|NCT04516746|183430173|SUPERIORITY||Vaccine efficacy|64.32|||<|0.001|TWO_SIDED|95.0|56.05|71.03|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||71.03|56.05|<0.001
91774386|NCT04516746|183430174|SUPERIORITY||Vaccine efficacy|69.65|||<|0.001|TWO_SIDED|95.0|60.68|76.57|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||76.57|60.68|<0.001
91774387|NCT04516746|183430175|SUPERIORITY||Vaccine efficacy|70.7|||<|0.001|TWO_SIDED|95.0|61.62|77.64|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||77.64|61.62|<0.001
91774388|NCT04516746|183430176|SUPERIORITY||Vaccine efficacy|73.68|||<|0.001|TWO_SIDED|95.0|65.13|80.13|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.13|65.13|<0.001
91646105|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.0103|TWO_SIDED|95.0|1.03|1.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.24|1.03|0.0103
91646106|NCT01236053|183184663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.4182|TWO_SIDED|95.0|0.95|1.14|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.95|0.4182
91774389|NCT04516746|183430177|SUPERIORITY||Vaccine efficacy|100.0|||<|0.001|ONE_SIDED|97.5|71.62||||Poisson regression exact conditional|||The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor \[age group at informed consent\] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).|||71.62|<0.001
91774390|NCT04516746|183430178|SUPERIORITY||Vaccine efficacy|84.97|||<|0.001|TWO_SIDED|95.0|58.97|94.5|||Poisson regression with robust variance|||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||94.50|58.97|<0.001
91774391|NCT04516746|183430179|SUPERIORITY||Vaccine efficacy|94.8||||0.005|TWO_SIDED|95.0|58.98|99.34|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||99.34|58.98|0.005
91774392|NCT04516746|183430186|SUPERIORITY||Vaccine efficacy|54.47|||||TWO_SIDED|95.0|46.48|61.26||||||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||61.26|46.48|
91774393|NCT03489863|183430187|NON_INFERIORITY|see above|Mean Difference (Net)|-18.0|||<|0.05|TWO_SIDED|95.0|-38.0|2.0|||ANCOVA|||The primary endpoint is non-inferiority in PRU, at 24 hours of prasugrel versus ticagrelor. Under the assumption of 0 difference at 24 hours in mean PRU between ticagrelor and prasugrel and a common standard deviation of 50 PRU, a sample size of 22 patients per group allows for the 95% CI to stay within ± 45 PRU with a 90% power and alpha = 0.05.||2|-38|<0.05
91774394|NCT01706458|183430200|OTHER|||||||0.906|||||||Log Rank|||||||0.9060
91774395|NCT03547518|183430207|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||||||0.111
91774396|NCT03547518|183430208|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||||||0.487
91774397|NCT03547518|183430209|SUPERIORITY|||||||0.0393|||||||t-test, 2 sided|||||||0.0393
91774398|NCT03547518|183430210|SUPERIORITY|||||||0.242|||||||t-test, 2 sided|||||||0.242
91774399|NCT03547518|183430211|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|||||||0.855
91774400|NCT02542865|183430270|SUPERIORITY||Mean Difference (Net)|-6.0|STANDARD_ERROR_OF_MEAN|1.56||0.0628|TWO_SIDED|95.0|-12.7|0.8|||ANCOVA|Analysis of variance(ANCOVA):cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group (fortified malt based food plus dietary counselling) minus Control Group (dietary counselling only).|||0.8|-12.7|0.0628
91774401|NCT02542865|183430270|SUPERIORITY||Mean Difference (Net)|-4.9||||0.039|||||||ANCOVA|ANCOVA:cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group minus Control Group. The corresponding CI is not presented as there is no direct back-transformation.|Since the distribution of the data was found to be more skewed with more zero counts than was anticipated at the time the trial was designed, an additional analysis of log (+1)-transformed data was performed.||||0.0390
91774402|NCT03164668|183430304|SUPERIORITY||Estimated mean ratio|0.31|||||TWO_SIDED|95.0|0.13|0.72|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||0.72|0.13|
91774403|NCT03164668|183430304|SUPERIORITY||Estimated mean ratio|0.98|||||TWO_SIDED|95.0|0.78|1.22|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||1.22|0.78|
91774404|NCT03164668|183430305|SUPERIORITY||Estimated mean ratio|3.03|||||TWO_SIDED|95.0|1.39|6.61|||||Model estimated mean ratio in puffs of e-cigarettes used per day among those randomized to conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||6.61|1.39|
91774405|NCT03164668|183430305|SUPERIORITY||Estimated mean ratio|0.74|||||TWO_SIDED|95.0|0.59|0.92|||||Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||0.92|0.59|
91774406|NCT00528957|183430333|NON_INFERIORITY_OR_EQUIVALENCE|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-8.5|||||TWO_SIDED|95.0|-21.5|4.5|||Normal approximation|The difference between the two proportions and its CI were based on normal approximation methods.|Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)|"The statistical hypotheses for the primary endpoint was as follows:~* Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations \< 400 copies/mL at Week 48.~* Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48."||4.5|-21.5|
91774407|NCT00528957|183430334|NON_INFERIORITY|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-0.9|||||TWO_SIDED|95.0|-13.7|11.8|||||The difference between the two proportions and its CI were based on normal approximation methods.|||11.8|-13.7|
91774408|NCT02675907|183430386|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||||||0.0034
91774409|NCT02675907|183430387|SUPERIORITY||||||<|0.05||||||Row 1 (SPID6)|t-test, 2 sided|||||||<0.05
91774410|NCT02675907|183430387|SUPERIORITY||||||<|0.01||||||Row 2 (SPID12)|t-test, 2 sided|||||||<0.01
91774411|NCT02675907|183430387|SUPERIORITY||||||<|0.01||||||Row 3 (SPID24)|t-test, 2 sided|||||||<0.01
91774412|NCT02675907|183430387|SUPERIORITY||||||<|0.01||||||Row 4 (SPID12-48)|t-test, 2 sided|||||||<0.01
91774413|NCT02675907|183430387|SUPERIORITY||||||<|0.01||||||Row 5 (SPID24-48)|t-test, 2 sided|||||||<0.01
91774414|NCT02675907|183430388|SUPERIORITY|||||||0.0076|||||||Log Rank|||||||0.0076
91774415|NCT02675907|183430389|SUPERIORITY||||||<|0.001||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||<0.001
91774416|NCT02675907|183430389|SUPERIORITY||||||<|0.01||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||<0.01
91774417|NCT02675907|183430389|SUPERIORITY||||||<|0.01||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||<0.01
91774418|NCT02675907|183430390|SUPERIORITY||||||<|0.05||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
91774419|NCT02675907|183430390|SUPERIORITY||||||<|0.05||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
91774420|NCT02675907|183430390|SUPERIORITY||||||<|0.05||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
91774421|NCT02675907|183430391|SUPERIORITY|||||||0.1228|||||||Log Rank|||||||0.1228
91774422|NCT02675907|183430392|SUPERIORITY|||||||0.1048|||||||Log Rank|||||||0.1048
91774423|NCT02675907|183430393|SUPERIORITY|||||||0.0451|||||||Cochran-Mantel-Haenszel|||||||0.0451
91774424|NCT02675907|183430394|SUPERIORITY|||||||0.0107|||||||Cochran-Mantel-Haenszel|||||||0.0107
91774425|NCT02675907|183430395|SUPERIORITY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||||||0.0781
91774426|NCT02675907|183430396|SUPERIORITY|||||||0.043|||||||Cochran-Mantel-Haenszel|||||||0.0430
91774427|NCT02675907|183430397|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.1070
91774428|NCT02675907|183430398|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0046
91774429|NCT01611792|183430399|SUPERIORITY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|9.02|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
91774430|NCT01611792|183430400|SUPERIORITY||Mean Difference (Net)|-6.67|STANDARD_DEVIATION|11.86||0.0038|TWO_SIDED||||||Mixed Models Analysis|||||||0.0038
91774431|NCT01611792|183430401|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|5.36||0.36|TWO_SIDED||||||Mixed Models Analysis|||||||0.36
91774432|NCT01611792|183430402|SUPERIORITY||Mean Difference (Net)|-1.31|STANDARD_DEVIATION|1.98||0.0018|TWO_SIDED||||||Mixed Models Analysis|||||||0.0018
91774433|NCT01611792|183430403|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
91774434|NCT01611792|183430404|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
91774435|NCT00960375|183430414|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||ANOVA|||Smoking reduction outcomes were examined in the randomized sample using data from baseline and post-treatment assessments. The variable examined was self-reported number of cigarettes smoked per day during the last 7 days. This variable was skewed so a natural log transformation was applied before linear mixed model analysis.||||0.489
91774436|NCT00960375|183430415|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED||||||ANOVA|||This outcome was examined in the randomized sample. Abstinence was defined as self-reported no smoking in the last 7 days + expired CO ≤ 10 PPM. To assess difference in change between conditions, we tested the significance of the condition-by-time interaction using repeated measured mixed models with a random participant effect. Time was binary: post-treatment versus baseline. We used a logistic model for binary outcomes.||||0.685
91774437|NCT00083889|183430416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5268|||<|0.0001|TWO_SIDED|95.0|0.4316|0.643||p-value from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.||0.6430|0.4316|<0.0001
91774438|NCT00083889|183430416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5136|||<|1e-05|TWO_SIDED|95.0|0.4196|0.6288||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).||0.6288|0.4196|<.00001
91774439|NCT00083889|183430417|SUPERIORITY_OR_OTHER||treatment difference|30.93|||<|0.001|TWO_SIDED|95.0|25.31|36.56|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||36.56|25.31|<0.001
91774440|NCT00083889|183430418|SUPERIORITY_OR_OTHER||treatment difference|33.66|||<|0.001|TWO_SIDED|95.0|27.62|39.69|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||39.69|27.62|<0.001
91774441|NCT00083889|183430419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.051|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0510
91774442|NCT00083889|183430419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.0128|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Wilcoxon (Mann-Whitney)||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0128
91774443|NCT00083889|183430419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8179||||0.049|TWO_SIDED|95.0|0.6692|0.9995||p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.9995|0.6692|0.0490
91774444|NCT00083889|183430420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5332|||<|0.0001|TWO_SIDED|95.0|0.4345|0.6544||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6544|0.4345|<0.0001
91774445|NCT00083889|183430420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516|||<|1e-05|TWO_SIDED|95.0|0.4191|0.6352||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6352|0.4191|<.00001
91774446|NCT00083889|183430421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5454|||<|0.0001|TWO_SIDED|95.0|0.4558|0.6526||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio \> 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6526|0.4558|<0.0001
91774447|NCT00083889|183430421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5417|||<|1e-05|TWO_SIDED|95.0|0.4519|0.6492||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6492|0.4519|<.00001
91774448|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.913|||<|0.0001|TWO_SIDED|95.0|1.376|2.45|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).||2.450|1.376|<.0001
91774449|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.935|||<|0.0001|TWO_SIDED|95.0|1.421|2.449|||Mixed Models Analysis|||Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.449|1.421|<.0001
91774450|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.948|||<|0.0001|TWO_SIDED|95.0|1.443|2.452|||Mixed Models Analysis|||Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.452|1.443|<.0001
91646107|NCT01236053|183184664|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.65||||0.3597|TWO_SIDED|95.0|0.26|1.62|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.62|0.26|0.3597
91774451|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001|TWO_SIDED|95.0|1.476|2.464|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.464|1.476|<.0001
91646108|NCT01236053|183184664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.1845|TWO_SIDED|95.0|0.21|1.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.34|0.21|0.1845
91613887|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533||||0.0071|TWO_SIDED|95.0|1.593|19.219|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||19.219|1.593|0.0071
91774452|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.983|||<|0.0001|TWO_SIDED|95.0|1.491|2.475|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.475|1.491|<.0001
91774453|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.005|||<|0.0001|TWO_SIDED|95.0|1.51|2.501|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.501|1.510|<.0001
91774454|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.018|||<|0.0001|TWO_SIDED|95.0|1.517|2.519|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.519|1.517|<.0001
91774455|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.0001|TWO_SIDED|95.0|1.522|2.559|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.559|1.522|<.0001
91774456|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.053|||<|0.0001|TWO_SIDED|95.0|1.522|2.584|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.584|1.522|<.0001
91774457|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.075|||<|0.0001|TWO_SIDED|95.0|1.515|2.635|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.635|1.515|<.0001
91774458|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||<|0.0001|TWO_SIDED|95.0|1.509|2.667|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.667|1.509|<.0001
91774459|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|||<|0.0001|TWO_SIDED|95.0|1.494|2.727|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.727|1.494|<.0001
91774460|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.123|||<|0.0001|TWO_SIDED|95.0|1.483|2.763|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.763|1.483|<.0001
91774461|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001|TWO_SIDED|95.0|1.461|2.83|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.830|1.461|<.0001
91774462|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.158|||<|0.0001|TWO_SIDED|95.0|1.447|2.869|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.869|1.447|<.0001
91774463|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.181|||<|0.0001|TWO_SIDED|95.0|1.42|2.941|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.941|1.420|<.0001
91774464|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.193|||<|0.0001|TWO_SIDED|95.0|1.404|2.983|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.983|1.404|<.0001
91774465|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.216|||<|0.0001|TWO_SIDED|95.0|1.373|3.059|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.059|1.373|<.0001
91708013|NCT00482170|183309136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.936|TWO_SIDED|95.0|0.63|1.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.64|0.63|0.936
91708014|NCT00482170|183309136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.42|TWO_SIDED|95.0|0.75|1.99||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.99|0.75|0.420
91708015|NCT00482170|183309136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.625|TWO_SIDED|95.0|0.71|1.79||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.79|0.71|0.625
91708016|NCT00482170|183309137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.21|TWO_SIDED|95.0|0.86|1.94||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.94|0.86|0.210
91774466|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.228|||<|0.0001|TWO_SIDED|95.0|1.355|3.102|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.102|1.355|<.0001
91774467|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.251|||<|0.0001|TWO_SIDED|95.0|1.321|3.18|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.180|1.321|<.0001
91774468|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.263|||<|0.0001|TWO_SIDED|95.0|1.302|3.225|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.225|1.302|<.0001
91774469|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.286|||<|0.0001|TWO_SIDED|95.0|1.266|3.305|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.305|1.266|<.0001
91708017|NCT00482170|183309137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.227|TWO_SIDED|95.0|0.85|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.85|0.227
91708018|NCT00482170|183309137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.22|TWO_SIDED|95.0|0.84|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.08|0.84|0.220
91708019|NCT00482170|183309137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.249|TWO_SIDED|95.0|0.84|2.0||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.00|0.84|0.249
91708020|NCT00482170|183309138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.48|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.21|1.48|<0.001
91708021|NCT00482170|183309138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.62|3.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.62|1.62|<0.001
91708022|NCT00482170|183309138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35|||<|0.001|TWO_SIDED|95.0|1.58|3.51||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.51|1.58|<0.001
91708023|NCT00482170|183309138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.64|3.59||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.59|1.64|<0.001
91646109|NCT01236053|183184664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9142|TWO_SIDED|95.0|0.58|1.84|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.84|0.58|0.9142
91710582|NCT01677182|183313841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.63||0.472|TWO_SIDED|97.5|-3.6|3.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.8|-3.6|0.472
91710583|NCT01677182|183313842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.998||||0.994|TWO_SIDED|95.0|0.651|1.53||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.530|0.651|0.994
91710584|NCT01677182|183313842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.886||||0.575|TWO_SIDED|95.0|0.58|1.352||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.352|0.580|0.575
91710585|NCT01677182|183313843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.978||||0.927|TWO_SIDED|95.0|0.606|1.577||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.577|0.606|0.927
91710586|NCT01677182|183313843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865||||0.553|TWO_SIDED|95.0|0.536|1.397||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.397|0.536|0.553
91710587|NCT00995722|183313845|NON_INFERIORITY_OR_EQUIVALENCE|N=80, (40 per group), 80% power to detect a group difference of 30%-35% and 5% significance level.|Mean Difference (Final Values)|-2.2||||0.37|TWO_SIDED|95.0|-7.2|2.8|||ANCOVA|ANCOVA used to compare mean values adjusting for the baseline value|QMG Score ranges from 0-15, where 0 is normal and a reduction in score represents imrovement.|Mean Ocular QMG Changes from Baseline to Week 16 . 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||2.8|-7.20|0.37
91710588|NCT00995722|183313846|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment|Mean Difference (Net)|6.56||||0.13|TWO_SIDED|95.0|-2.59|15.71|||ANCOVA||Scores ranges fro 0-100 , where 100 is normal and an increase in score represents an improvement|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||15.71|-2.59|0.13
91710589|NCT00995722|183313847|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment|Mean Difference (Final Values)|-3.81||||0.15|TWO_SIDED|95.0|-9.37|1.75|||ANCOVA||Ranges from 0-60, where 0 is Normal and a reduction in score represents improvement.|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||1.75|-9.37|0.15
91710590|NCT00995722|183313848|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16.|Mean Difference (Final Values)|16.98||||0.16|TWO_SIDED|95.0|-9.22|43.17|||ANCOVA||Ranges 0-100, where 100 is normal and an increase in score represents an improvement.|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||43.17|-9.22|0.16
91710591|NCT01431313|183313861|OTHER|Mixed effects model across all time points.||||||0.002|||||||Mixed Models Analysis|||||||0.002
91710592|NCT01431313|183313861|OTHER|Mixed effects model across all time points.||||||0.003|||||||Mixed Models Analysis|||||||0.003
91710593|NCT01431313|183313861|OTHER|Mixed effects model across all time points.||||||0.66|||||||Mixed Models Analysis|||||||0.66
91710594|NCT01431313|183313863|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91710595|NCT01431313|183313863|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91710596|NCT01431313|183313863|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91710597|NCT01431313|183313864|OTHER|Mixed effects model across all time points.||||||0.8|||||||Mixed Models Analysis|||||||0.8
91710598|NCT01431313|183313864|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
91710599|NCT01431313|183313864|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
91710600|NCT01431313|183313865|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91710601|NCT01431313|183313865|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91710602|NCT01431313|183313865|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91710603|NCT01431313|183313866|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91710604|NCT01431313|183313866|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91710605|NCT01431313|183313866|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91710606|NCT01431313|183313867|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91710607|NCT01431313|183313867|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91710608|NCT01431313|183313868|OTHER|Mixed effects model across all doses.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91710609|NCT01431313|183313868|OTHER|Mixed effects model across all doses.||||||0.21|||||||Mixed Models Analysis|||||||0.21
91710610|NCT01431313|183313868|OTHER|Mixed effects model across all doses.||||||0.59|||||||Mixed Models Analysis|||||||0.59
91710611|NCT00762762|183313869|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
91710612|NCT00762762|183313870|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
91710613|NCT00762762|183313871|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
91710614|NCT00762762|183313872|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
91710615|NCT00762762|183313873|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
91710616|NCT00762762|183313874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91710617|NCT00762762|183313875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91710618|NCT00762762|183313876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91710619|NCT00762762|183313877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91710620|NCT00762762|183313878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91710621|NCT02542397|183313900|SUPERIORITY|"It has been reported that, based on the Edmonton Symptom Assessment Scale (ESAS) pain scale, about 30% of cancer patients receiving standard of care pain management experienced \>= 2-point improvement in pain score between visits \[Ref\].~Ref: Scharpf, J., et al., The role of pain in head and neck cancer recurrence and survivorship. Arch Otolaryngol Head Neck Surg, 2009. 135(8): p. 789-94."|Exact binomial proportion|0.5556|||<|0.0001|TWO_SIDED|95.0|0.414|0.6908||The a priori threshold for statistical significance was alpha = 0.10.|Exact binomial test of proportions|||A single-stage design was used to test the hypothesis that the pain improvement rate, assessed by the Edmonton Symptom Assessment Scale, is \<= 0.30. Our study targeted enrollment of 71 evaluable subjects for the final analysis; 54 subjects met the criteria at study closure. Assuming a one-sided alpha=0.10 significance level, 71 evaluable subjects would provide approximately 90% power to reject the null hypothesis (based on an exact binomial test) assuming the true pain improvement rate is 0.45.||.6908|.4140|<0.0001
91710622|NCT00105989|183313931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05.|Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.||||<0.001
91710623|NCT00105989|183313932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Frequencies are analyzed using Cochran-Mantel-Haenszel controlling for investigator||||||<0.001
91710624|NCT00105989|183313933|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||||||0.003
91710625|NCT00105989|183313934|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|Frequencies were analyzed using Cochran-Mantel-Haenszel controlling for investigator.||||||0.003
91710626|NCT00105989|183313935|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710627|NCT00105989|183313935|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.016
91710628|NCT00105989|183313936|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91710629|NCT00105989|183313937|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710630|NCT00105989|183313937|SUPERIORITY_OR_OTHER|||||||0.153||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.153
91710631|NCT00105989|183313938|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91710632|NCT00105989|183313939|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
91710633|NCT00105989|183313939|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
91710634|NCT00105989|183313940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91710635|NCT00105989|183313941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint for all Subscales during Acute phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710636|NCT00105989|183313941|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Anxiety Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.334
91710637|NCT00105989|183313941|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Core Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.019
91710638|NCT00105989|183313941|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Maier Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.046
91774470|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001|TWO_SIDED|95.0|1.246|3.351|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.351|1.246|<.0001
91774471|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.321|||<|0.0001|TWO_SIDED|95.0|1.209|3.433|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.433|1.209|<.0001
91774472|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.333|||<|0.0001|TWO_SIDED|95.0|1.188|3.479|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.479|1.188|<.0001
91774473|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.356||||0.0001|TWO_SIDED|95.0|1.15|3.562|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.562|1.150|0.0001
91774474|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.369||||0.0002|TWO_SIDED|95.0|1.128|3.609|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.609|1.128|0.0002
91774475|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.391||||0.0003|TWO_SIDED|95.0|1.089|3.693|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.693|1.089|0.0003
91774476|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.404||||0.0004|TWO_SIDED|95.0|1.067|3.74|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.740|1.067|0.0004
91774477|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.426||||0.0007|TWO_SIDED|95.0|1.027|3.825|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.825|1.027|0.0007
91774478|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.439||||0.0009||95.0|1.005|3.872|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.872|1.005|0.0009
91774479|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.461||||0.0013|TWO_SIDED|95.0|0.964|3.958|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.958|0.964|0.0013
91774480|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474||||0.0016|TWO_SIDED|95.0|0.942|4.006|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.006|0.942|0.0016
91774481|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.496||||0.0022|TWO_SIDED|95.0|0.901|4.092|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.092|0.901|0.0022
91774482|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.509||||0.0026|TWO_SIDED|95.0|0.878|4.14|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.140|0.878|0.0026
91774483|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.531||||0.0034|TWO_SIDED|95.0|0.836|4.226|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.226|0.836|0.0034
91613888|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.964||||0.3042|TWO_SIDED|95.0|0.542|7.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||7.114|0.542|0.3042
91774484|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.544||||0.004|TWO_SIDED|95.0|0.813|4.274|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.274|0.813|0.0040
91774485|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.566||||0.0051|TWO_SIDED|95.0|0.772|4.361|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.361|0.772|0.0051
91774486|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.579||||0.0058|TWO_SIDED|95.0|0.748|4.41|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.410|0.748|0.0058
91774487|NCT00083889|183430424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.602||||0.0071|TWO_SIDED|95.0|0.706|4.497|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.497|0.706|0.0071
91774488|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.165|||<|0.0001|TWO_SIDED|95.0|2.234|4.095|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.095|2.234|<.0001
91774489|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.205|||<|0.0001|TWO_SIDED|95.0|2.318|4.092|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.092|2.318|<.0001
91774490|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.228|||<|0.0001|TWO_SIDED|95.0|2.358|4.097|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.097|2.358|<.0001
91774491|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.268|||<|0.0001|TWO_SIDED|95.0|2.418|4.119|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.119|2.418|<.0001
91774492|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.291|||<|0.0001|TWO_SIDED|95.0|2.443|4.139|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.139|2.443|<.0001
91774493|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.331|||<|0.0001|TWO_SIDED|95.0|2.474|4.189|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.189|2.474|<.0001
91774494|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.354|||<|0.0001||95.0|2.484|4.224|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.224|2.484|<.0001
91774495|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.395|||<|0.0001|TWO_SIDED|95.0|2.489|4.3|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.300|2.489|<.0001
91708024|NCT00482170|183309139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.5|3.65||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.65|1.50|<0.001
91774496|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.417|||<|0.0001|TWO_SIDED|95.0|2.486|4.348|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.348|2.486|<.0001
91774497|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.458|||<|0.0001|TWO_SIDED|95.0|2.469|4.446|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.446|2.469|<.0001
91774498|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48|||<|0.0001|TWO_SIDED|95.0|2.455|4.505|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.505|2.455|<.0001
91774499|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.521|||<|0.0001|TWO_SIDED|95.0|2.422|4.62|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.620|2.422|<.0001
91774500|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.543|||<|0.0001|TWO_SIDED|95.0|2.399|4.687|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.687|2.399|<.0001
91774501|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.584|||<|0.0001||95.0|2.354|4.814|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.814|2.354|<.0001
91774502|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.606|||<|0.0001|TWO_SIDED|95.0|2.326|4.887|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.887|2.326|<.0001
91774503|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.647|||<|0.0001|TWO_SIDED|95.0|2.272|5.022|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.022|2.272|<.0001
91774504|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||<|0.0001|TWO_SIDED|95.0|2.24|5.099|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.099|2.240|<.0001
91774505|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||<|0.0001|TWO_SIDED|95.0|2.18|5.24|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.240|2.180|<.0001
91774506|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.733|||<|0.0001|TWO_SIDED|95.0|2.145|5.32|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.320|2.145|<.0001
91774507|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.773|||<|0.0001|TWO_SIDED|95.0|2.08|5.466|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.466|2.080|<.0001
91774508|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.796|||<|0.0001|TWO_SIDED|95.0|2.043|5.548|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.548|2.043|<.0001
91774509|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.836|||<|0.0001|TWO_SIDED|95.0|1.975|5.698|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.698|1.975|<.0001
91774510|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|||<|0.0001|TWO_SIDED|95.0|1.936|5.781|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.781|1.936|<.0001
91774511|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.899||||0.0002|TWO_SIDED|95.0|1.866|5.933|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.933|1.866|0.0002
91774512|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.922||||0.0002|TWO_SIDED|95.0|1.826|6.018|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.018|1.826|0.0002
91774513|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.962||||0.0004|TWO_SIDED|95.0|1.753|6.172|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.172|1.753|0.0004
91774514|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.985||||0.0006||95.0|1.712|6.258|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.258|1.712|0.0006
91774515|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026||||0.001|TWO_SIDED|95.0|1.638|6.413|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.413|1.638|0.0010
91774516|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.048||||0.0012|TWO_SIDED|95.0|1.597|6.5|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.500|1.597|0.0012
91774517|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.089||||0.0018|TWO_SIDED|95.0|1.521|6.656|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.656|1.521|0.0018
91774518|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.111||||0.0022|TWO_SIDED|95.0|1.479|6.743|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.743|1.479|0.0022
91774519|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.152||||0.0031|TWO_SIDED|95.0|1.403|6.901|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.901|1.403|0.0031
91774520|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.174||||0.0037||95.0|1.36|6.988|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.988|1.360|0.0037
91774521|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.215||||0.0048|TWO_SIDED|95.0|1.283|7.147|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.147|1.283|0.0048
91774522|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.237||||0.0056|TWO_SIDED|95.0|1.24|7.235|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.235|1.240|0.0056
91774523|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.278||||0.0071|TWO_SIDED|95.0|1.162|7.394|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.394|1.162|0.0071
91646110|NCT01236053|183184664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6524|TWO_SIDED|95.0|0.49|1.57|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.57|0.49|0.6524
91774524|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.0081|TWO_SIDED|95.0|1.119|7.482|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.482|1.119|0.0081
91774525|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.341||||0.0099|TWO_SIDED|95.0|1.041|7.642|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.642|1.041|0.0099
91774526|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.364||||0.0111|TWO_SIDED|95.0|0.997|7.73|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.730|0.997|0.0111
91774527|NCT00083889|183430425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.404||||0.0133|TWO_SIDED|95.0|0.918|7.89|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.890|0.918|0.0133
91774528|NCT00083889|183430426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5404|||<|0.0001|TWO_SIDED|95.0|0.4532|0.6444||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6444|0.4532|<0.0001
91774529|NCT00083889|183430426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5418|||<|1e-05|TWO_SIDED|95.0|0.4536|0.6473||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6473|0.4536|<.00001
91774530|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.486|||<|0.0001|TWO_SIDED|95.0|3.852|7.119|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).||7.119|3.852|<.0001
91774531|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.535|||<|0.0001|TWO_SIDED|95.0|3.955|7.115|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.115|3.955|<.0001
91774532|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.562|||<|0.0001|TWO_SIDED|95.0|4.0|7.124|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.124|4.000|<.0001
91774533|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.611|||<|0.0001|TWO_SIDED|95.0|4.061|7.162|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.162|4.061|<.0001
91774534|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.639|||<|0.0001|TWO_SIDED|95.0|4.083|7.195|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.195|4.083|<.0001
91774535|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.688|||<|0.0001|TWO_SIDED|95.0|4.1|7.276|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.276|4.100|<.0001
91774536|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.715|||<|0.0001|TWO_SIDED|95.0|4.098|7.333|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.333|4.098|<.0001
91774537|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.764|||<|0.0001|TWO_SIDED|95.0|4.075|7.454|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.454|4.075|<.0001
91646111|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.2875|TWO_SIDED|95.0|0.17|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.70|0.17|0.2875
91774538|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.792|||<|0.0001|TWO_SIDED|95.0|4.053|7.531|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.531|4.053|<.0001
91774539|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.841|||<|0.0001|TWO_SIDED|95.0|3.998|7.684|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.684|3.998|<.0001
91710639|NCT00105989|183313941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710640|NCT00105989|183313941|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value for Sleep Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.319
91710641|NCT00105989|183313941|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Depressed Mood Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.275
91710642|NCT00105989|183313942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Anxiety Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||<0.001
91710643|NCT00105989|183313942|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Core Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
91710644|NCT00105989|183313942|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Maier Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
91710645|NCT00105989|183313942|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Retardation Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
91710646|NCT00105989|183313942|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Sleep Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.001
91710647|NCT00105989|183313942|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Depressed Mood Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
91710648|NCT00105989|183313943|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for all Change from Baseline to Endpoint measures in the Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710649|NCT00105989|183313943|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.273
91710650|NCT00105989|183313943|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-value for Headache Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.968
91710651|NCT00105989|183313943|SUPERIORITY_OR_OTHER|||||||0.998||95.0||||P-value for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.998
91710652|NCT00105989|183313943|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||P-value for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.703
91710653|NCT00105989|183313943|SUPERIORITY_OR_OTHER|||||||0.346||95.0||||P-value for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.346
91710654|NCT00105989|183313943|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.963
91710655|NCT00105989|183313944|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value for pairwise comparison of Least Squares Means for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.792
91710656|NCT00105989|183313944|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-value for pairwise comparison of Least Squares Means for Headache Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.407
91774540|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.868|||<|0.0001|TWO_SIDED|95.0|3.96|7.777|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.777|3.960|<.0001
91774541|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.917|||<|0.0001|TWO_SIDED|95.0|3.88|7.955|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.955|3.880|<.0001
91774542|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.945|||<|0.0001|TWO_SIDED|95.0|3.83|8.06|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.060|3.830|<.0001
91774543|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.994|||<|0.0001|TWO_SIDED|95.0|3.731|8.257|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.257|3.731|<.0001
91774544|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.021|||<|0.0001|TWO_SIDED|95.0|3.672|8.37|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.370|3.672|<.0001
91774545|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.071|||<|0.0001|TWO_SIDED|95.0|3.56|8.581|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.581|3.560|<.0001
91774546|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.098|||<|0.0001|TWO_SIDED|95.0|3.495|8.701|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.701|3.495|<.0001
91774547|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.147|||<|0.0001|TWO_SIDED|95.0|3.373|8.921|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.921|3.373|<.0001
91774548|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.174|||<|0.0001|TWO_SIDED|95.0|3.303|9.045|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.045|3.303|<.0001
91774549|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.224|||<|0.0001|TWO_SIDED|95.0|3.174|9.273|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.273|3.174|<.0001
91774550|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.251||||0.0001|TWO_SIDED|95.0|3.101|9.401|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.401|3.101|0.0001
91774551|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.0002|TWO_SIDED|95.0|2.966|9.634|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.634|2.966|0.0002
91774552|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.327||||0.0003|TWO_SIDED|95.0|2.89|9.765|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.765|2.890|0.0003
91774553|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.377||||0.0006|TWO_SIDED|95.0|2.751|10.002|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.002|2.751|0.0006
91774554|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.404||||0.0008|TWO_SIDED|95.0|2.673|10.135|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.135|2.673|0.0008
91581644|NCT01190514|183053266|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|101.31|||||TWO_SIDED|90.0|97.17|105.64|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.64|97.17|
91774555|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.453||||0.0013|TWO_SIDED|95.0|2.53|10.376|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.376|2.530|0.0013
91774556|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.0016|TWO_SIDED|95.0|2.451|10.51|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.510|2.451|0.0016
91774557|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0025|TWO_SIDED|95.0|2.306|10.754|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.754|2.306|0.0025
91774558|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.557||||0.003|TWO_SIDED|95.0|2.224|10.889|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.889|2.224|0.0030
91774559|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.606||||0.0043|TWO_SIDED|95.0|2.077|11.135|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.135|2.077|0.0043
91774560|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.634||||0.0051|TWO_SIDED|95.0|1.995|11.272|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.272|1.995|0.0051
91774561|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.683||||0.0068|TWO_SIDED|95.0|1.847|11.519|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.519|1.847|0.0068
91774562|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.71||||0.0079|TWO_SIDED|95.0|1.764|11.657|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.657|1.764|0.0079
91774563|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.759||||0.01|TWO_SIDED|95.0|1.613|11.905|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.905|1.613|0.0100
91774564|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.787||||0.0114|TWO_SIDED|95.0|1.53|12.043|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.043|1.530|0.0114
91774565|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.836||||0.0141|TWO_SIDED|95.0|1.378|12.293|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.293|1.378|0.0141
91774566|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.863||||0.0157|TWO_SIDED|95.0|1.294|12.432|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.432|1.294|0.0157
91774567|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.912||||0.0189|TWO_SIDED|95.0|1.142|12.683|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.683|1.142|0.0189
91774568|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.94||||0.0208|TWO_SIDED|95.0|1.057|12.822|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.822|1.057|0.0208
91774569|NCT00083889|183430427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.989||||0.0244|TWO_SIDED|95.0|0.904|13.074|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||13.074|0.904|0.0244
91774570|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.459|||<|0.0001|TWO_SIDED|95.0|0.805|2.114|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.114|0.805|<.0001
91774571|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.453|||<|0.0001|TWO_SIDED|95.0|0.827|2.079|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.079|0.827|<.0001
91774572|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.837|2.063|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.063|0.837|<.0001
91774573|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.444|||<|0.0001|TWO_SIDED|95.0|0.847|2.041|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.041|0.847|<.0001
91774574|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.848|2.032|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.032|0.848|<.0001
91774575|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.434|||<|0.0001|TWO_SIDED|95.0|0.844|2.024|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.024|0.844|<.0001
91774576|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.431|||<|0.0001|TWO_SIDED|95.0|0.838|2.023|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.023|0.838|<.0001
91774577|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.424|||<|0.0001|TWO_SIDED|95.0|0.819|2.029|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.029|0.819|<.0001
91774578|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.421|||<|0.0001|TWO_SIDED|95.0|0.805|2.037|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.037|0.805|<.0001
91774579|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.415|||<|0.0001|TWO_SIDED|95.0|0.774|2.056|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.056|0.774|<.0001
91774580|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.411|||<|0.0001|TWO_SIDED|95.0|0.753|2.069|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.069|0.753|<.0001
91774581|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.405|||<|0.0001|TWO_SIDED|95.0|0.711|2.099|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.099|0.711|<.0001
91710657|NCT00105989|183313944|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value for pairwise comparison of Least Squares Means for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.475
91710658|NCT00105989|183313944|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value for pairwise comparison of Least Squares Means for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.241
91710659|NCT00105989|183313944|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for pairwise comparison of Least Squares Means for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.885
91710660|NCT00105989|183313944|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||P-value for pairwise comparison of Least Squares Means for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.717
91710661|NCT00105989|183313945|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710662|NCT00105989|183313945|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.157
91710663|NCT00105989|183313946|SUPERIORITY_OR_OTHER|||||||0.979||95.0|||||t-test, 2 sided|||||||0.979
91710664|NCT00105989|183313947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710665|NCT00105989|183313947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in the Continuation Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710666|NCT00105989|183313948|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Global Score|t-test, 2 sided|||||||0.029
91710667|NCT00105989|183313948|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Work/School.|t-test, 2 sided|||||||0.022
91710668|NCT00105989|183313948|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Social Life.|t-test, 2 sided|||||||0.110
91710669|NCT00105989|183313948|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Family Life/Home Responsibilities.|t-test, 2 sided|||||||0.021
91710670|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint in all SF-36 subscales in the Acute Phase were \<0.001|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710671|NCT00105989|183313949|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value for Physical Component Summary Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.947
91710672|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary Change to Endpoint|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710673|NCT00105989|183313949|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for Physical Functioning Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.118
91710674|NCT00105989|183313949|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||P-value for Bodily Pain Change from Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.550
91710675|NCT00105989|183313949|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Role Limitations Due to Physical Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.029
91710676|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Role Limitations Due to Emotional Problems Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710677|NCT00105989|183313949|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for General Health Perceptions Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
91710678|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710679|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Social Function Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710680|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Vitality Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710681|NCT00105989|183313949|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||P-value for Rate Current Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.815
91710682|NCT00105989|183313949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Health Compared to a Year Ago Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710683|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Component Summary.|t-test, 2 sided|||||||0.415
91710684|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Component Summary.|t-test, 2 sided|||||||0.002
91710685|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Functioning.|t-test, 2 sided|||||||0.731
91710686|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Bodily Pain.|t-test, 2 sided|||||||0.438
91710687|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Physical.|t-test, 2 sided|||||||0.029
91710688|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Emotional problems.|t-test, 2 sided|||||||0.003
91710689|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-General Health Perceptions.|t-test, 2 sided|||||||0.391
91710690|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Health.|t-test, 2 sided|||||||0.001
91710691|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Social Functioning.|t-test, 2 sided|||||||0.142
91710692|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Vitality.|t-test, 2 sided|||||||0.240
91710693|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Rate General Health.|t-test, 2 sided|||||||0.615
91710694|NCT00105989|183313950|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Health Compared to a Year Ago.|t-test, 2 sided|||||||0.218
91710695|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for change in number of Primary Health Care Provider Visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.838
91710696|NCT00105989|183313951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710697|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P-value for change in number of Psychologist/Therapist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.236
91710698|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.145||95.0||||P-value for change in number of Other Specialist Physician visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.145
91710699|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for change in number of Other (Specified by Patient) visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.423
91710700|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for change in number of Primary Health Care Provider visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.325
91710701|NCT00105989|183313951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710702|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.915||95.0||||P-value for change in number of Psychologist/Therapist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.915
91710703|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||P-value for change in number of Other Specialist Physician visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.223
91710704|NCT00105989|183313951|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-value for change in number of Other (Specified by Patient) visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.362
91710705|NCT00105989|183313952|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Primary Health Care Provider visits.|t-test, 2 sided|||||||0.462
91710706|NCT00105989|183313952|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychiatrist visits.|t-test, 2 sided|||||||0.668
91710707|NCT00105989|183313952|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychologist/Therapist visits.|t-test, 2 sided|||||||0.746
91710708|NCT00105989|183313952|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other Specialist Physician visits.|t-test, 2 sided|||||||0.511
91710709|NCT00105989|183313952|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other (Specified by Patient) Provider visits.|t-test, 2 sided|||||||0.271
91710710|NCT00105989|183313953|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.506
91710711|NCT00105989|183313953|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.057
91710712|NCT00105989|183313954|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||t-test, 2 sided|||||||0.826
91710713|NCT00105989|183313955|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value for Change in Number of Missed Paid Work Hours in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.105
91710714|NCT00105989|183313955|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value for Change in Number of Missed Paid Work Hours in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.174
91710715|NCT00105989|183313956|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||t-test, 2 sided|||||||0.037
91710716|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.785
91710717|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.354
91710718|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.170
91710719|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.825||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.825
91710720|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.877
91710721|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.009
91710722|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.670
91710723|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.100
91710724|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.021
91710725|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.047
91710726|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.023
91710727|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.668
91710728|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.136
91710729|NCT00105989|183313957|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.152
91710730|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710731|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710732|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710733|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710734|NCT00105989|183313958|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.005
91710735|NCT00105989|183313958|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.050
91710736|NCT00105989|183313958|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.022
91710737|NCT00105989|183313958|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
91710738|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710739|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710740|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710741|NCT00105989|183313958|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.186
91710742|NCT00105989|183313958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91774582|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.402||||0.0001|TWO_SIDED|95.0|0.685|2.119|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.119|0.685|0.0001
91774583|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.396||||0.0003|TWO_SIDED|95.0|0.634|2.157|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.157|0.634|0.0003
91774584|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.392||||0.0005|TWO_SIDED|95.0|0.604|2.18|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.180|0.604|0.0005
91774585|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.386||||0.0012|TWO_SIDED|95.0|0.547|2.225|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.225|0.547|0.0012
91774586|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.383||||0.0018|TWO_SIDED|95.0|0.514|2.252|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.252|0.514|0.0018
91774587|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.376||||0.0035|TWO_SIDED|95.0|0.451|2.301|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.301|0.451|0.0035
91774588|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.373||||0.0049|TWO_SIDED|95.0|0.416|2.33|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.330|0.416|0.0049
91774589|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.367||||0.0084|TWO_SIDED|95.0|0.35|2.383|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.383|0.350|0.0084
91774590|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.363||||0.011|TWO_SIDED|95.0|0.313|2.414|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.414|0.313|0.0110
91774591|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.357||||0.0168|TWO_SIDED|95.0|0.245|2.47|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.470|0.245|0.0168
91774592|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.354||||0.0208|TWO_SIDED|95.0|0.206|2.501|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.501|0.206|0.0208
91774593|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.348||||0.0293|TWO_SIDED|95.0|0.136|2.559|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.559|0.136|0.0293
91774594|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.344||||0.0348|TWO_SIDED|95.0|0.096|2.592|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.592|0.096|0.0348
91774595|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.338||||0.0459|TWO_SIDED|95.0|0.024|2.652|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.652|0.024|0.0459
91774596|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.335||||0.0528|TWO_SIDED|95.0|-0.016|2.685|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.685|-0.016|0.0528
91774597|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.328||||0.0663|TWO_SIDED|95.0|-0.09|2.746|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.746|-0.090|0.0663
91774598|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.325||||0.0744|TWO_SIDED|95.0|-0.131|2.78|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.780|-0.131|0.0744
91774599|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.319||||0.0898|TWO_SIDED|95.0|-0.205|2.842|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.842|-0.205|0.0898
91774600|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.315||||0.0988|TWO_SIDED|95.0|-0.246|2.877|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.877|-0.246|0.0988
91774601|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.309||||0.1156|TWO_SIDED|95.0|-0.321|2.94|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.940|-0.321|0.1156
91774602|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.306||||0.1252|TWO_SIDED|95.0|-0.363|2.975|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.975|-0.363|0.1252
91774603|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1429|TWO_SIDED|95.0|-0.439|3.038|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.038|-0.439|0.1429
91774604|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.296||||0.1529|TWO_SIDED|95.0|-0.481|3.074|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.074|-0.481|0.1529
91774605|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.1711|TWO_SIDED|95.0|-0.558|3.138|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.138|-0.558|0.1711
91774606|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.1813|TWO_SIDED|95.0|-0.6|3.173|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.173|-0.600|0.1813
91774607|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.1998|TWO_SIDED|95.0|-0.677|3.238|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.238|-0.677|0.1998
91774608|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277||||0.21|TWO_SIDED|95.0|-0.72|3.273|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.273|-0.720|0.2100
91774609|NCT00083889|183430428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.2283|TWO_SIDED|95.0|-0.797|3.338|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.338|-0.797|0.2283
91613889|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.726||||0.41|TWO_SIDED|95.0|0.471|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.471|0.4100
91774610|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.214|||<|0.0001|TWO_SIDED|95.0|0.719|1.708|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.708|0.719|<.0001
91774611|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.216|||<|0.0001|TWO_SIDED|95.0|0.729|1.703|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.703|0.729|<.0001
91774612|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.217|||<|0.0001|TWO_SIDED|95.0|0.731|1.704|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.704|0.731|<.0001
91774613|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.73|1.71|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.710|0.730|<.0001
91774614|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.221|||<|0.0001|TWO_SIDED|95.0|0.727|1.716|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.716|0.727|<.0001
91774615|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.224|||<|0.0001|TWO_SIDED|95.0|0.716|1.732|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.732|0.716|<.0001
91774616|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.225|||<|0.0001|TWO_SIDED|95.0|0.707|1.744|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.744|0.707|<.0001
91774617|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.228|||<|0.0001|TWO_SIDED|95.0|0.687|1.769|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.769|0.687|<.0001
91774618|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|||<|0.0001|TWO_SIDED|95.0|0.673|1.785|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.785|0.673|<.0001
91519996|NCT03565887|182914102|SUPERIORITY|The primary efficacy endpoints were tested sequentially. The Day 1 Hour 6 time point was tested first and if P\<0.05, the Day 14 Hour 2 time point was tested at a significance level of 0.05. If the Day 1 Hour 6 endpoint is statistically significant (at the 0.05 level) but Day 14 Hour 2 was not statistically significant (at the 0.05 level), the study will still be considered positive.|||||<|0.0001||||||If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|ANCOVA|2 sided t-test with treatment as fixed factor and baseline as covariate.||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0001
91774619|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.232|||<|0.0001|TWO_SIDED|95.0|0.646|1.818|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.818|0.646|<.0001
91774620|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.233|||<|0.0001|TWO_SIDED|95.0|0.629|1.838|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.838|0.629|<.0001
91774621|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.236||||0.0002|TWO_SIDED|95.0|0.595|1.876|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.876|0.595|0.0002
91710743|NCT00105989|183313958|SUPERIORITY_OR_OTHER|||||||0.308||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.308
91708025|NCT00482170|183309139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.77||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.77|1.83|<0.001
91708026|NCT00482170|183309139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58|||<|0.001|TWO_SIDED|95.0|1.62|4.12||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.12|1.62|<0.001
91708027|NCT00482170|183309139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45|||<|0.001|TWO_SIDED|95.0|1.55|3.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.86|1.55|<0.001
91708028|NCT00482170|183309140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.681|TWO_SIDED|95.0|0.73|1.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.62|0.73|0.681
91708029|NCT00482170|183309140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.947|TWO_SIDED|95.0|0.67|1.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.54|0.67|0.947
91708030|NCT00482170|183309140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.36|0.59|0.604
91708031|NCT00482170|183309140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.43|TWO_SIDED|95.0|0.57|1.27||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.27|0.57|0.430
91708032|NCT00482170|183309141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.072|TWO_SIDED|95.0|0.48|1.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.03|0.48|0.072
91708033|NCT00482170|183309141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.205|TWO_SIDED|95.0|0.86|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.86|0.205
91708034|NCT00482170|183309141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.434|TWO_SIDED|95.0|0.78|1.78||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.78|0.78|0.434
91708035|NCT00482170|183309141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.69|1.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.55|0.69|0.857
91708036|NCT00482170|183309142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.837|TWO_SIDED|95.0|0.7|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.70|0.837
91708037|NCT00482170|183309142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.172|TWO_SIDED|95.0|0.87|2.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.15|0.87|0.172
91708038|NCT00482170|183309142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.24|0.94|0.096
91710744|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.773
91708039|NCT00482170|183309142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.88|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.08|0.88|0.164
91708040|NCT00482170|183309143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.356|TWO_SIDED|95.0|0.83|1.69||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.69|0.83|0.356
91519997|NCT03565887|182914103|SUPERIORITY|If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|||||<|0.0151|||||||ANCOVA|||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0151
91708041|NCT00482170|183309143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.737|TWO_SIDED|95.0|0.73|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.73|0.737
91708042|NCT00482170|183309143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.156|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.156
91708043|NCT00482170|183309143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.29|TWO_SIDED|95.0|0.85|1.76||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.76|0.85|0.290
91708044|NCT00482170|183309144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.065|TWO_SIDED|95.0|0.5|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.02|0.50|0.065
91708045|NCT00482170|183309144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1|TWO_SIDED|95.0|0.5|1.06||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.06|0.50|0.100
91708046|NCT00482170|183309144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.298|TWO_SIDED|95.0|0.54|1.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.21|0.54|0.298
91708047|NCT00482170|183309144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.148|TWO_SIDED|95.0|0.51|1.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.11|0.51|0.148
91708048|NCT00482170|183309145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.098|TWO_SIDED|95.0|0.94|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.94|0.098
91708049|NCT00482170|183309145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.311|TWO_SIDED|95.0|0.82|1.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.87|0.82|0.311
91708050|NCT00482170|183309145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.376|TWO_SIDED|95.0|0.79|1.85||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.85|0.79|0.376
91708051|NCT00482170|183309145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.299|TWO_SIDED|95.0|0.83|1.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.86|0.83|0.299
91708052|NCT00482170|183309146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.494|TWO_SIDED|95.0|0.6|1.28||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.28|0.60|0.494
91708053|NCT00482170|183309146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.036|TWO_SIDED|95.0|0.44|0.97||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.97|0.44|0.036
91710745|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.405
91774622|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.237||||0.0003|TWO_SIDED|95.0|0.575|1.899|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.899|0.575|0.0003
91774623|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.0005|TWO_SIDED|95.0|0.537|1.942|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.942|0.537|0.0005
91710746|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.443
91774624|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.241||||0.0008|TWO_SIDED|95.0|0.515|1.967|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.967|0.515|0.0008
91774625|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.244||||0.0015|TWO_SIDED|95.0|0.474|2.013|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.013|0.474|0.0015
91519998|NCT00689221|182914104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.021||||0.8623|TWO_SIDED|95.0|0.808|1.291||P-value is not adjusted for multiple testing.|Log Rank|||||1.291|0.808|0.8623
91710747|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.384||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.384
91710748|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.268
91710749|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.093
91710750|NCT00105989|183313959|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.566
91710751|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.979
91710752|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.132
91710753|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.180
91710754|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.163
91710755|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.844
91710756|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.609
91710757|NCT00105989|183313960|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.071
91710758|NCT00105989|183313961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710759|NCT00105989|183313961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710760|NCT00105989|183313962|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||t-test, 2 sided|||||||0.314
91710761|NCT00105989|183313963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710762|NCT00105989|183313963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
91710763|NCT00105989|183313964|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||t-test, 2 sided|||||||0.891
91710764|NCT00105989|183313965|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.659
91710765|NCT00105989|183313965|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.064
91710766|NCT00105989|183313965|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.224
91710767|NCT00105989|183313965|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.210
91710768|NCT00105989|183313966|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for Change from Baseline: systolic blood pressure.|t-test, 2 sided|||||||0.134
91710769|NCT00105989|183313966|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value for Change from Baseline: diastolic blood pressure.|t-test, 2 sided|||||||0.816
91710770|NCT00105989|183313967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91710771|NCT00105989|183313968|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.007
91710772|NCT00105989|183313969|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.035
91708054|NCT00482170|183309146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.079|TWO_SIDED|95.0|0.45|1.04||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.04|0.45|0.079
91774626|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.0021|TWO_SIDED|95.0|0.45|2.04|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.040|0.450|0.0021
91774627|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.248||||0.0037|TWO_SIDED|95.0|0.406|2.089|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.089|0.406|0.0037
91774628|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.249||||0.0048|TWO_SIDED|95.0|0.382|2.116|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.116|0.382|0.0048
91774629|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.251||||0.0074|TWO_SIDED|95.0|0.336|2.167|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.167|0.336|0.0074
91774630|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.253||||0.0092|TWO_SIDED|95.0|0.31|2.196|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.196|0.310|0.0092
91774631|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.255||||0.0132|TWO_SIDED|95.0|0.262|2.248|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.248|0.262|0.0132
91774632|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.257||||0.0159|TWO_SIDED|95.0|0.236|2.278|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.278|0.236|0.0159
91774633|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.259||||0.0213|TWO_SIDED|95.0|0.187|2.332|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.332|0.187|0.0213
91708055|NCT00482170|183309146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.063|TWO_SIDED|95.0|0.46|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.02|0.46|0.063
91774634|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.261||||0.0248|TWO_SIDED|95.0|0.16|2.362|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.362|0.160|0.0248
91774635|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263||||0.0318|TWO_SIDED|95.0|0.11|2.416|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.416|0.110|0.0318
91774636|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.265||||0.036|TWO_SIDED|95.0|0.083|2.447|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.447|0.083|0.0360
91774637|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.267||||0.0443|TWO_SIDED|95.0|0.032|2.502|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.502|0.032|0.0443
91774638|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.269||||0.0493|TWO_SIDED|95.0|0.004|2.533|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.533|0.004|0.0493
91646112|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.2042|TWO_SIDED|95.0|0.15|1.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.51|0.15|0.2042
91774639|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.0587|TWO_SIDED|95.0|-0.047|2.589|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.589|-0.047|0.0587
91774640|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.273||||0.0642|TWO_SIDED|95.0|-0.075|2.62|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.620|-0.075|0.0642
91774641|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.275||||0.0746|TWO_SIDED|95.0|-0.127|2.677|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.677|-0.127|0.0746
91774642|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.276||||0.0806|TWO_SIDED|95.0|-0.155|2.708|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.708|-0.155|0.0806
91774643|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.279||||0.0917|TWO_SIDED|95.0|-0.207|2.765|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.765|-0.207|0.0917
91774644|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.098|TWO_SIDED|95.0|-0.236|2.797|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.797|-0.236|0.0980
91774645|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.283||||0.1095|TWO_SIDED|95.0|-0.288|2.854|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.854|-0.288|0.1095
91774646|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.284||||0.1161|TWO_SIDED|95.0|-0.318|2.886|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.886|-0.318|0.1161
91774647|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.128|TWO_SIDED|95.0|-0.37|2.944|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.944|-0.370|0.1280
91774648|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.288||||0.1346|TWO_SIDED|95.0|-0.399|2.976|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.976|-0.399|0.1346
91774649|NCT00083889|183430429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.291||||0.1466|TWO_SIDED|95.0|-0.452|3.034|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||3.034|-0.452|0.1466
91774650|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.929||||0.0001|TWO_SIDED|95.0|0.46|1.398|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.398|0.460|0.0001
91774651|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.922|||<|0.0001||95.0|0.469|1.375|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.375|0.469|<.0001
91774652|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.918|||<|0.0001||95.0|0.471|1.365|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.365|0.471|<.0001
91774653|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.911|||<|0.0001||95.0|0.469|1.352|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.352|0.469|<.0001
91774654|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.907|||<|0.0001||95.0|0.466|1.348|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.348|0.466|<.0001
91774655|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.899|||<|0.0001||95.0|0.453|1.345|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.345|0.453|<.0001
91646113|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.4733|TWO_SIDED|95.0|0.38|8.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||8.06|0.38|0.4733
91708056|NCT00482170|183309147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.62|1.33||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.33|0.62|0.628
91708057|NCT00482170|183309147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.203|TWO_SIDED|95.0|0.51|1.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.15|0.51|0.203
91710773|NCT00105989|183313970|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
91710774|NCT00105989|183313971|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91774656|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.895||||0.0001||95.0|0.444|1.347|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.347|0.444|0.0001
91774657|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.888||||0.0002||95.0|0.421|1.355|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.355|0.421|0.0002
91774658|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||0.0003||95.0|0.406|1.362|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.362|0.406|0.0003
91774659|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.877||||0.0006||95.0|0.375|1.379|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.379|0.375|0.0006
91774660|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.873||||0.0009||95.0|0.356|1.39|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.390|0.356|0.0009
91774661|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.866||||0.002||95.0|0.318|1.414|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.414|0.318|0.0020
91774662|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.862||||0.0029||95.0|0.295|1.428|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.428|0.295|0.0029
91774663|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.854||||0.0055||95.0|0.251|1.457|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.457|0.251|0.0055
91774664|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0076||95.0|0.226|1.475|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.475|0.226|0.0076
91774665|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.843||||0.0129||95.0|0.179|1.508|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.508|0.179|0.0129
91774666|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.839||||0.0168||95.0|0.151|1.527|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.527|0.151|0.0168
91774667|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.832||||0.0257||95.0|0.101|1.563|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.563|0.101|0.0257
91774668|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.828||||0.0318||95.0|0.072|1.583|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.583|0.072|0.0318
91774669|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.821||||0.0447||95.0|0.019|1.622|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.622|0.019|0.0447
91774670|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.817||||0.0529||95.0|-0.01|1.643|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.643|-0.010|0.0529
91774671|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.809||||0.0696||95.0|-0.065|1.683|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.683|-0.065|0.0696
91519999|NCT01292239|182914125|SUPERIORITY_OR_OTHER||(see comment)|27.5|||<|0.0001|TWO_SIDED|95.0|14.38|40.56||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||40.56|14.38|<0.0001
91774672|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.805||||0.0797||95.0|-0.095|1.706|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.706|-0.095|0.0797
91774673|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.798||||0.0994||95.0|-0.151|1.747|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.747|-0.151|0.0994
91774674|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.794||||0.111||95.0|-0.182|1.77|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.770|-0.182|0.1110
91774675|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.787||||0.1328||95.0|-0.239|1.813|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.813|-0.239|0.1328
91774676|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.783||||0.1454||95.0|-0.271|1.836|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.836|-0.271|0.1454
91774677|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.776||||0.1686||95.0|-0.329|1.88|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.880|-0.329|0.1686
91774678|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.771||||0.1817||95.0|-0.361|1.904|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.904|-0.361|0.1817
91774679|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764||||0.2055||95.0|-0.419|1.948|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.948|-0.419|0.2055
91774680|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76||||0.2188||95.0|-0.452|1.972|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.972|-0.452|0.2188
91774681|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753||||0.2427||95.0|-0.51|2.016|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.016|-0.510|0.2427
91774682|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.749||||0.2559||95.0|-0.543|2.041|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.041|-0.543|0.2559
91774683|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.742||||0.2794||95.0|-0.602|2.086|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.086|-0.602|0.2794
91774684|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.738||||0.2923||95.0|-0.635|2.111|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.111|-0.635|0.2923
91774685|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.3152||95.0|-0.695|2.156|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.156|-0.695|0.3152
91774686|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.726||||0.3276||95.0|-0.728|2.181|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.181|-0.728|0.3276
91774687|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719||||0.3497||95.0|-0.788|2.227|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.227|-0.788|0.3497
91774688|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.715||||0.3616||95.0|-0.822|2.252|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.252|-0.822|0.3616
91774689|NCT00083889|183430430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.708||||0.3827||95.0|-0.882|2.298|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.298|-0.882|0.3827
91774690|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.897|||<|0.0001|TWO_SIDED|95.0|1.261|2.533|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.533|1.261|<.0001
91774691|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.924|||<|0.0001||95.0|1.309|2.539|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.539|1.309|<.0001
91774692|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.939|||<|0.0001||95.0|1.331|2.546|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.546|1.331|<.0001
91774693|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.965|||<|0.0001||95.0|1.363|2.568|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.568|1.363|<.0001
91774694|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98|||<|0.0001||95.0|1.376|2.584|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.584|1.376|<.0001
91774695|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.007|||<|0.0001||95.0|1.392|2.622|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.622|1.392|<.0001
91774696|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.022|||<|0.0001||95.0|1.396|2.647|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.647|1.396|<.0001
91774697|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.048|||<|0.0001||95.0|1.397|2.7|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.700|1.397|<.0001
91774698|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.063|||<|0.0001||95.0|1.394|2.732|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.732|1.394|<.0001
91774699|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.0001||95.0|1.383|2.797|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.797|1.383|<.0001
91774700|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.105|||<|0.0001||95.0|1.374|2.836|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.836|1.374|<.0001
91774701|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.132|||<|0.0001||95.0|1.353|2.91|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.910|1.353|<.0001
91774702|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001||95.0|1.339|2.954|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.954|1.339|<.0001
91774703|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.173|||<|0.0001||95.0|1.311|3.036|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.036|1.311|<.0001
91774704|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.188|||<|0.0001||95.0|1.294|3.082|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.082|1.294|<.0001
91774705|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.215|||<|0.0001||95.0|1.26|3.169|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.169|1.260|<.0001
91774706|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|||<|0.0001||95.0|1.241|3.219|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.219|1.241|<.0001
91774707|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.256|||<|0.0001||95.0|1.203|3.309|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.309|1.203|<.0001
91774708|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.271|||<|0.0001||95.0|1.182|3.361|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.361|1.182|<.0001
91710775|NCT00105989|183313972|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.019
91774709|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001||95.0|1.142|3.454|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.454|1.142|<.0001
91774710|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.313||||0.0001||95.0|1.119|3.507|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.507|1.119|0.0001
91774711|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.0003||95.0|1.076|3.603|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.603|1.076|0.0003
91774712|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.354||||0.0004||95.0|1.052|3.657|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.657|1.052|0.0004
91774713|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.381||||0.0007||95.0|1.008|3.754|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.754|1.008|0.0007
91774714|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.396||||0.0009||95.0|0.983|3.809|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.809|0.983|0.0009
91774715|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.423||||0.0014||95.0|0.938|3.908|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.908|0.938|0.0014
91774716|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.438||||0.0017||95.0|0.912|3.963|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.963|0.912|0.0017
91774717|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.464||||0.0025||95.0|0.866|4.063|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.063|0.866|0.0025
91774718|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.479||||0.003||95.0|0.84|4.119|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.119|0.840|0.0030
91774719|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.0042||95.0|0.792|4.219|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.219|0.792|0.0042
91774720|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.521||||0.0049||95.0|0.766|4.275|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.275|0.766|0.0049
91774721|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.547||||0.0064||95.0|0.718|4.377|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.377|0.718|0.0064
91774722|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.562||||0.0073||95.0|0.691|4.433|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.433|0.691|0.0073
91774723|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.589||||0.0091||95.0|0.643|4.535|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.535|0.643|0.0091
91708058|NCT00482170|183309147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.222|TWO_SIDED|95.0|0.51|1.17||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.17|0.51|0.222
91774724|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.604||||0.0103||95.0|0.616|4.592|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.592|0.616|0.0103
91774725|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.631||||0.0125||95.0|0.567|4.695|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.695|0.567|0.0125
91774726|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645||||0.0138||95.0|0.539|4.752|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.752|0.539|0.0138
91774727|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.672||||0.0164||95.0|0.49|4.855|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.855|0.490|0.0164
91774728|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.687||||0.0179||95.0|0.462|4.912|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.912|0.462|0.0179
91708059|NCT00482170|183309147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.263|TWO_SIDED|95.0|0.53|1.19||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.19|0.53|0.263
91708060|NCT00482170|183309148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.914|TWO_SIDED|95.0|0.7|1.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.50|0.70|0.914
91708061|NCT00482170|183309148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.827|TWO_SIDED|95.0|0.7|1.57||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.57|0.70|0.827
91708062|NCT00482170|183309148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.712|TWO_SIDED|95.0|0.61|1.4||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.40|0.61|0.712
91708063|NCT00482170|183309148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.733|TWO_SIDED|95.0|0.62|1.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.39|0.62|0.733
91708064|NCT00482170|183309149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.95||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.95|0.95|0.090
91708065|NCT00482170|183309149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.154|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.154
91708066|NCT00482170|183309149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.037|TWO_SIDED|95.0|1.02|2.22||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.22|1.02|0.037
91708067|NCT00482170|183309149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.028|TWO_SIDED|95.0|1.05|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.24|1.05|0.028
91708068|NCT00482170|183309150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.022|TWO_SIDED|95.0|1.06|2.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.21|1.06|0.022
91708069|NCT00482170|183309150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.005|TWO_SIDED|95.0|1.17|2.41||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.41|1.17|0.005
91774729|NCT00083889|183430431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.714||||0.0208||95.0|0.413|5.015|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||5.015|0.413|0.0208
91774730|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049||||0.0004|TWO_SIDED|95.0|0.022|0.076|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).||0.076|0.022|0.0004
91708070|NCT00482170|183309150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.076|TWO_SIDED|95.0|0.97|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.97|0.076
91708071|NCT00482170|183309150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.049|TWO_SIDED|95.0|1.0|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.11|1.00|0.049
91710776|NCT00105989|183313973|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.005
91774731|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.075|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|0.022|0.0003
91710777|NCT00105989|183313974|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.031
91774732|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.074|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.022|0.0003
91774733|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0003||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0003
91710778|NCT00105989|183313975|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91710779|NCT00105989|183313976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91710780|NCT00105989|183313977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91710781|NCT00105989|183313978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91710782|NCT00105989|183313979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91774734|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.0004||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0004
91774735|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0005||95.0|0.02|0.071|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.020|0.0005
91774736|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0007||95.0|0.019|0.07|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.019|0.0007
91774737|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044||||0.0011||95.0|0.017|0.07|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.017|0.0011
91774738|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043||||0.0016||95.0|0.016|0.07|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.016|0.0016
91774739|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0029||95.0|0.014|0.07|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.014|0.0029
91774740|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0041||95.0|0.013|0.07|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.013|0.0041
91774741|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.0076||95.0|0.011|0.071|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.011|0.0076
91708072|NCT00482170|183309151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.32|2.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.83|1.32|<0.001
91774742|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.0105||95.0|0.009|0.071|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.009|0.0105
91774743|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0179||95.0|0.007|0.072|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.007|0.0179
91774744|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0236||95.0|0.005|0.072|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.005|0.0236
91774745|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.037||95.0|0.002|0.073|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.073|0.002|0.0370
91774746|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0464||95.0|0.001|0.074|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.001|0.0464
91774747|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0667||95.0|-0.002|0.075|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|-0.002|0.0667
91774748|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.08||95.0|-0.004|0.076|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.076|-0.004|0.0800
91774749|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035||||0.107||95.0|-0.007|0.077|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.077|-0.007|0.1070
91774750|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.1237||95.0|-0.009|0.078|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.078|-0.009|0.1237
91774751|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1561||95.0|-0.013|0.079|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.079|-0.013|0.1561
91774752|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1752||95.0|-0.015|0.08|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.080|-0.015|0.1752
91774753|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.2112||95.0|-0.018|0.081|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.081|-0.018|0.2112
91774754|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.2319||95.0|-0.02|0.082|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.082|-0.020|0.2319
91774755|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2698||95.0|-0.023|0.084|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.084|-0.023|0.2698
91774756|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.291||95.0|-0.025|0.085|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.085|-0.025|0.2910
91774757|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.3293||95.0|-0.029|0.086|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.086|-0.029|0.3293
91774758|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.3504||95.0|-0.031|0.087|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.087|-0.031|0.3504
91774759|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.3881||95.0|-0.034|0.089|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.089|-0.034|0.3881
91774760|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.4086||95.0|-0.036|0.09|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.090|-0.036|0.4086
91774761|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.4449||95.0|-0.04|0.091|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.091|-0.040|0.4449
91774762|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4646||95.0|-0.042|0.092|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.092|-0.042|0.4646
91774763|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.499||95.0|-0.046|0.094|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.094|-0.046|0.4990
91774764|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.5176||95.0|-0.048|0.095|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.095|-0.048|0.5176
91774765|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023||||0.5501||95.0|-0.051|0.097|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.097|-0.051|0.5501
91774766|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.5675||95.0|-0.054|0.098|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.098|-0.054|0.5675
91774767|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.5979||95.0|-0.057|0.099|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.099|-0.057|0.5979
91774768|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.6141||95.0|-0.059|0.1|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.100|-0.059|0.6141
91774769|NCT00083889|183430432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.6424||95.0|-0.063|0.102|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.102|-0.063|0.6424
91774770|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026|||<|0.0001|TWO_SIDED|95.0|2.088|5.965|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).||5.965|2.088|<.0001
91774771|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.165|||<|0.0001||95.0|2.269|6.061|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.061|2.269|<.0001
91774772|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.243|||<|0.0001||95.0|2.358|6.128|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.128|2.358|<.0001
91774773|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.382|||<|0.0001||95.0|2.494|6.269|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.269|2.494|<.0001
91774774|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.459|||<|0.0001||95.0|2.558|6.361|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.361|2.558|<.0001
91774775|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||<|0.0001||95.0|2.65|6.547|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.547|2.650|<.0001
91710783|NCT00105989|183313980|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.004
91774776|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.676|||<|0.0001||95.0|2.689|6.662|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.662|2.689|<.0001
91774777|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.815|||<|0.0001||95.0|2.741|6.889|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.889|2.741|<.0001
91774778|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.892|||<|0.0001||95.0|2.76|7.024|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.024|2.760|<.0001
91774779|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.031|||<|0.0001||95.0|2.78|7.283|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.283|2.780|<.0001
91774780|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.109|||<|0.0001||95.0|2.783|7.435|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.435|2.783|<.0001
91774781|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.248|||<|0.0001||95.0|2.776|7.72|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.720|2.776|<.0001
91774782|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.325|||<|0.0001||95.0|2.767|7.884|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.884|2.767|<.0001
91774783|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.464|||<|0.0001||95.0|2.741|8.188|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.188|2.741|<.0001
91774784|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.542||||0.0001||95.0|2.723|8.361|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.361|2.723|0.0001
91774785|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.681||||0.0002||95.0|2.683|8.679|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.679|2.683|0.0002
91774786|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.758||||0.0003||95.0|2.657|8.859|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.859|2.657|0.0003
91774787|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.898||||0.0004||95.0|2.607|9.188|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.188|2.607|0.0004
91774788|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.975||||0.0006||95.0|2.576|9.374|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.374|2.576|0.0006
91774789|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.114||||0.0009||95.0|2.517|9.711|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.711|2.517|0.0009
91710784|NCT00105989|183313981|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.010
91774790|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.191||||0.0011||95.0|2.482|9.9|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.900|2.482|0.0011
91774791|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.331||||0.0015||95.0|2.417|10.244|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.244|2.417|0.0015
91774792|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.408||||0.0018||95.0|2.379|10.436|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.436|2.379|0.0018
91774793|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.547||||0.0025||95.0|2.309|10.785|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.785|2.309|0.0025
91774794|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.624||||0.0029||95.0|2.269|10.98|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.980|2.269|0.0029
91774795|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.764||||0.0037||95.0|2.195|11.332|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.332|2.195|0.0037
91774796|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.841||||0.0042||95.0|2.153|11.529|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.529|2.153|0.0042
91774797|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98||||0.0053||95.0|2.076|11.884|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.884|2.076|0.0053
91774798|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.057||||0.0059||95.0|2.032|12.083|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.083|2.032|0.0059
91774799|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.197||||0.0072||95.0|1.953|12.441|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.441|1.953|0.0072
91774800|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.274||||0.0079||95.0|1.908|12.64|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.640|1.908|0.0079
91774801|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.413||||0.0093||95.0|1.826|13.0|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.000|1.826|0.0093
91774802|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.491||||0.0101||95.0|1.78|13.201|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.201|1.780|0.0101
91774803|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63||||0.0117||95.0|1.697|13.562|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.562|1.697|0.0117
91774804|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.707||||0.0126||95.0|1.65|13.764|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.764|1.650|0.0126
91774805|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.846||||0.0144||95.0|1.565|14.127|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.127|1.565|0.0144
91774806|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.924||||0.0153||95.0|1.518|14.329|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.329|1.518|0.0153
91774807|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.063||||0.0172||95.0|1.432|14.693|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.693|1.432|0.0172
91774808|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.14||||0.0182||95.0|1.384|14.896|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.896|1.384|0.0182
91774809|NCT00083889|183430433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.279||||0.0201||95.0|1.297|15.261|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||15.261|1.297|0.0201
91774810|NCT00168844|183430454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
91774811|NCT00168844|183430454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
91774812|NCT00168844|183430455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.269|STANDARD_ERROR_OF_MEAN|0.996||0.0011||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0011
91774813|NCT00168844|183430455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.242|STANDARD_ERROR_OF_MEAN|0.999|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
91774814|NCT00168844|183430456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001|TWO_SIDED|95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
91774815|NCT00168844|183430456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.||||||<0.0001
91774816|NCT00168844|183430457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg - Placebo|||0.890|0.687|0.0002
91774817|NCT00168844|183430457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg - Placebo|||0.828|0.635|<0.0001
91774818|NCT00168844|183430501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91774819|NCT00168844|183430501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91774820|NCT00168844|183430502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91774821|NCT00168844|183430502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91774822|NCT00168844|183430503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91774823|NCT00168844|183430503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91774824|NCT00168844|183430504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91774825|NCT00168844|183430504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91774826|NCT00168844|183430505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91774827|NCT00168844|183430505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91774828|NCT00168844|183430506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91774829|NCT00168844|183430506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91774830|NCT03309020|183430556|OTHER|||||||0.802||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery||||0.802
91774831|NCT03309020|183430557|OTHER|||||||0.713||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery||||.713
91774832|NCT03309020|183430558|OTHER||Odds Ratio (OR)|0.1|||||TWO_SIDED|95.0|0.01|0.69|||||Odds of eye with at least 20/40 best corrected visual acuity (BCVA) 12 months after cataract surgery for controls vs. EVD survivors|Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses||0.69|0.01|
91774833|NCT03309020|183430559|OTHER|||||||0.832||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.832
91774834|NCT03309020|183430560|OTHER|||||||0.995||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.995
91774835|NCT03309020|183430561|OTHER|||||||0.441||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||0.441
91774836|NCT03309020|183430562|OTHER|||||||0.892||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.892
91774837|NCT03309020|183430563|OTHER|||||||0.913||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.913
91774838|NCT03309020|183430564|OTHER|||||||0.106||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||.106
91774839|NCT03309020|183430565|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||0.09
91774840|NCT03062358|183430604|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018|TWO_SIDED|95.0|0.63|0.99||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.99|0.63|0.0180
91774841|NCT03062358|183430605|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0032|TWO_SIDED|95.0|0.6|0.92||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.92|0.60|0.0032
91774842|NCT03062358|183430606|OTHER||Percent Difference|11.4||||4e-05|TWO_SIDED|95.0|6.7|16.0|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|16.0|6.7|0.00004
91774843|NCT03062358|183430608|OTHER||Percent Difference|5.4||||0.13281|TWO_SIDED|95.0|-4.1|14.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|14.8|-4.1|0.13281
91774844|NCT03062358|183430609|OTHER||Hazard Ratio (HR)|0.72||||0.0019|TWO_SIDED|95.0|0.58|0.9||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.90|0.58|0.0019
91774845|NCT05893862|183430612|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|9.22|||<|0.0001|TWO_SIDED|90.0|7.4|11.04|||t-test, 1 sided|||||11.04|7.40|<0.0001
91774846|NCT05893862|183430612|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|8.44||||0.0141|TWO_SIDED|90.0|6.31|10.56|||t-test, 1 sided|||||10.56|6.31|0.0141
91774847|NCT05893862|183430612|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|10.8|||<|0.0001|TWO_SIDED|90.0|8.85|12.74|||t-test, 1 sided|||||12.74|8.85|<0.0001
91774848|NCT05893862|183430612|OTHER|LS Mean Difference Week 4 Hr|LS Mean Difference|6.43||||0.1045|TWO_SIDED|90.0|3.96|8.91|||t-test, 1 sided|||||8.91|3.96|0.1045
91774849|NCT05893862|183430612|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|6.52|||||TWO_SIDED|90.0|4.66|8.38||||||||8.38|4.66|
91774850|NCT05893862|183430612|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|7.33||||||90.0|4.74|9.93||||||||9.93|4.74|
91774851|NCT05893862|183430612|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|6.42|||||TWO_SIDED|90.0|3.95|8.88||||||||8.88|3.95|
91774852|NCT05893862|183430612|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|2.79|||||TWO_SIDED|90.0|0.81|4.76||||||||4.76|0.81|
91774853|NCT05893862|183430615|OTHER|LS Mean Difference 0.5 Hr|LS Mean Difference|0.52|||||TWO_SIDED|90.0|-1.11|2.14||||||||2.14|-1.11|
91774854|NCT05893862|183430615|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|0.36|||||TWO_SIDED|90.0|-1.26|1.98||||||||1.98|-1.26|
91774855|NCT05893862|183430615|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|1.31|||||TWO_SIDED|90.0|-1.04|3.66||||||||3.66|-1.04|
91774856|NCT05893862|183430615|OTHER|LS Mean Difference 3 hr|LS Mean Difference|4.27|||||TWO_SIDED|90.0|1.9|6.64||||||||6.64|1.90|
91646114|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.7867|TWO_SIDED|95.0|0.26|5.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||5.85|0.26|0.7867
91646115|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53||||0.0049|TWO_SIDED|95.0|1.47|8.5|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||8.50|1.47|0.0049
91646116|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.87||||0.0218|TWO_SIDED|95.0|1.17|7.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||7.08|1.17|0.0218
91520000|NCT01292239|182914126|SUPERIORITY_OR_OTHER||(see comment)|32.6|||<|0.0001|TWO_SIDED|95.0|19.75|45.4||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||45.40|19.75|<0.0001
91520001|NCT00765388|182914139|SUPERIORITY_OR_OTHER|||||||0.96|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.96
91774857|NCT05893862|183430615|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|7.0|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
91774858|NCT05893862|183430615|OTHER|LS Mean Difference 6 Hr|LS Mean Difference|7.85|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
91774859|NCT05893862|183430615|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|9.25|||||TWO_SIDED|90.0|6.71|11.8||||||||11.80|6.71|
91646117|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.849|TWO_SIDED|95.0|0.27|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.27|0.8490
91774860|NCT05893862|183430615|OTHER|LS Mean Difference 12 Hr|LS Mean Difference|4.81|||||TWO_SIDED|90.0|2.27|7.35||||||||7.35|2.27|
91774861|NCT05893862|183430615|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|3.57|||||TWO_SIDED|90.0|0.91|6.23||||||||6.23|0.91|
91774862|NCT05893862|183430615|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|5.01|||||TWO_SIDED|90.0|3.18|6.85||||||||6.85|3.18|
91774863|NCT05893862|183430615|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|3.95|||||TWO_SIDED|90.0|1.56|6.34||||||||6.34|1.56|
91774864|NCT05893862|183430615|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|3.92|||||TWO_SIDED|90.0|1.49|6.35||||||||6.35|1.49|
91774865|NCT05893862|183430615|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|4.68|||||TWO_SIDED|90.0|2.33|7.03||||||||7.03|2.33|
91774866|NCT05893862|183430615|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|4.79|||||TWO_SIDED|90.0|2.45|7.12||||||||7.12|2.45|
91774867|NCT05893862|183430615|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|4.82|||||TWO_SIDED|90.0|1.93|7.71||||||||7.71|1.93|
91774868|NCT05893862|183430615|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|5.3|||||TWO_SIDED|90.0|2.51|8.09||||||||8.09|2.51|
91774869|NCT05893862|183430615|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|5.85|||||TWO_SIDED|90.0|2.97|8.74||||||||8.74|2.97|
91774870|NCT05893862|183430615|OTHER|LS Mean Difference 16 Hr|LS Mean Difference|4.12|||||TWO_SIDED|90.0|1.79|6.45||||||||6.45|1.79|
91774871|NCT05893862|183430615|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|0.78|||||TWO_SIDED|90.0|-1.69|3.26||||||||3.26|-1.69|
91774872|NCT00880698|183430627|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.1||||0.62|TWO_SIDED|95.0|-20.6|14.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-uninfected participants experiencing a new grade \>=3 adverse event|||14.8|-20.6|0.62
91774873|NCT00880698|183430627|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-21.0|23.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-infected participants experiencing a new grade \>=3 adverse event|||23.4|-21.0|1.00
91774874|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.9|||<|0.001|TWO_SIDED|95.0|11.5|46.1||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||46.1|11.5|<0.001
91774875|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|49.8|||<|0.001|TWO_SIDED|95.0|27.1|68.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||68.6|27.1|<0.001
91774876|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1||||0.2|TWO_SIDED|95.0|-11.3|24.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||24.8|-11.3|0.20
91774877|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2||||0.19|TWO_SIDED|95.0|-10.6|36.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||36.7|-10.6|0.19
91774878|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||<|0.001|TWO_SIDED|95.0|0.9|36.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||36.4|0.9|<0.001
91774879|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.4|||<|0.001|TWO_SIDED|95.0|4.7|50.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||50.6|4.7|<0.001
91774880|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|8.0|42.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||42.9|8.0|<0.001
91774881|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|58.6|||<|0.001|TWO_SIDED|95.0|37.2|75.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||75.9|37.2|<0.001
91774882|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4||||0.024|TWO_SIDED|95.0|-1.7|34.2||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||34.2|-1.7|0.024
91774883|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.7||||0.34|TWO_SIDED|95.0|-12.0|35.5||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||35.5|-12.0|0.34
91774884|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|51.4|||<|0.001|TWO_SIDED|95.0|34.3|66.3||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||66.3|34.3|<0.001
91774885|NCT00880698|183430628|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|65.1|||<|0.001|TWO_SIDED|95.0|42.7|81.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||81.7|42.7|<0.001
91774886|NCT05316597|183430732|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.914|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.914
91774887|NCT05316597|183430733|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.554|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||.554
91774888|NCT05316597|183430734|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.905|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|||||||0.905
91774889|NCT05316597|183430735|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.076|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.076
91774890|NCT05316597|183430735|SUPERIORITY|||||||0.02||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.02
91774891|NCT05316597|183430736|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.21|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.210
91774892|NCT05316597|183430736|SUPERIORITY|||||||0.57||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.57
91774893|NCT05316597|183430737|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.921|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.921
91774894|NCT05316597|183430737|SUPERIORITY|||||||0.82||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.82
91774895|NCT05316597|183430738|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.265|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.265
91774896|NCT05316597|183430738|SUPERIORITY|||||||0.63||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.63
91774897|NCT05316597|183430739|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.724|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.724
91774898|NCT05316597|183430740|SUPERIORITY||Mean Difference (Final Values)|-2.85||||0.716|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.716
91774899|NCT05316597|183430741|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.852|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.852
91774900|NCT05316597|183430742|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.166|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.166
91774901|NCT05316597|183430743|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.046|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.046
91774902|NCT02766023|183430766|SUPERIORITY||Risk Difference (RD)|0.04||||0.467|TWO_SIDED|95.0|-0.1|0.18|||Fisher Exact|||||0.18|-0.10|0.467
91774903|NCT02766023|183430767|SUPERIORITY||Odds Ratio (OR)|0.54||||0.031|TWO_SIDED|95.0|0.3|0.95|||Chi-squared|||||0.95|0.30|0.031
91774904|NCT02766023|183430768|SUPERIORITY||Risk Difference (RD)|0.03||||0.643|TWO_SIDED|95.0|-0.08|0.15|||Chi-squared|||Analysis is for self-reported compliance||0.15|-0.08|0.643
91774905|NCT02766023|183430768|SUPERIORITY||Risk Difference (RD)|0.05||||0.446|TWO_SIDED|95.0|-0.07|0.17|||Chi-squared|||Analysis is for compliance assessed by staining.||0.17|-0.07|0.446
91774906|NCT02766023|183430777|SUPERIORITY||Odds Ratio (OR)|79.64|||<|0.001|TWO_SIDED|95.0|29.02|218.57|||Chi-squared|||||218.57|29.02|<0.001
91774907|NCT02766023|183430785|SUPERIORITY||Odds Ratio (OR)|72.78|||<|0.001|TWO_SIDED|95.0|28.07|188.66|||Chi-squared|||||188.66|28.07|<0.001
91774908|NCT02766023|183430786|SUPERIORITY||Odds Ratio (OR)|0.54||||0.03|TWO_SIDED|95.0|0.31|0.94|||Chi-squared|||||0.94|0.31|0.030
91774909|NCT00286468|183430788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level, and \>=80% of subjects meeting per protocol criteria.||-0.19|-0.59|<0.001
91774910|NCT00286468|183430788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.73|-0.33||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per-protocol criteria.||-0.33|-0.73|<0.001
91774911|NCT00286468|183430789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.13||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.13|-0.33|<0.001
91774912|NCT00286468|183430789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.18|-0.38|<0.001
91774913|NCT00286468|183430790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.53|<0.001
91774914|NCT00286468|183430790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.61|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.61|<0.001
91774915|NCT00286468|183430791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.57|<0.001
91774916|NCT00286468|183430791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.68|-0.36||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.68|<0.001
91774917|NCT00286468|183430792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.54|<0.001
91774918|NCT00286468|183430792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
91774919|NCT00286468|183430793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.17|-0.54|<0.001
91774920|NCT00286468|183430793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.71|-0.34||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.71|<0.001
91774921|NCT00286468|183430794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1||||0.006|TWO_SIDED|95.0|-20.8|-3.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.4|-20.8|0.006
91774922|NCT00286468|183430794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-28.0|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-28.0|<0.001
91774923|NCT00286468|183430795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||<|0.001|TWO_SIDED|95.0|-22.5|-7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-7.2|-22.5|<0.001
91774924|NCT00286468|183430795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||<|0.001|TWO_SIDED|95.0|-27.7|-12.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.4|-27.7|<0.001
91774925|NCT00286468|183430796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.01|TWO_SIDED|95.0|-19.3|-2.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.6|-19.3|0.010
91774926|NCT00286468|183430796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.8|-9.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.1|-25.8|<0.001
91774927|NCT00286468|183430797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.2|-8.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.2|-25.2|<0.001
91774928|NCT00286468|183430797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<|0.001|TWO_SIDED|95.0|-23.9|-6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-23.9|<0.001
91774929|NCT00286468|183430798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1||||0.03|TWO_SIDED|95.0|-19.2|-1.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-19.2|0.030
91774930|NCT00286468|183430798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.012|TWO_SIDED|95.0|-20.8|-2.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.5|-20.8|0.012
91774931|NCT00286468|183430799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.701|TWO_SIDED|95.0|-11.6|7.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-11.6|0.701
91774932|NCT00286468|183430799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.228|TWO_SIDED|95.0|-15.7|3.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.7|-15.7|0.228
91774933|NCT00286468|183430800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0||||0.097|TWO_SIDED|95.0|-19.6|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-19.6|0.097
91774934|NCT00286468|183430800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.014|TWO_SIDED|95.0|-23.9|-2.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.7|-23.9|0.014
91774935|NCT00286468|183430801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8||||0.241|TWO_SIDED|95.0|-18.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-18.3|0.241
91520002|NCT00765388|182914141|SUPERIORITY_OR_OTHER|||||||0.92|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.92
91710785|NCT00105989|183313982|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.003
91708073|NCT00482170|183309151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.78|3.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.87|1.78|<0.001
91708074|NCT00482170|183309151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.19||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.19|1.42|<0.001
91708075|NCT00482170|183309151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.52|3.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.39|1.52|<0.001
91708076|NCT00482170|183309152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.057|TWO_SIDED|95.0|0.99|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.11|0.99|0.057
91708077|NCT00482170|183309152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.151|TWO_SIDED|95.0|0.9|1.96||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.96|0.90|0.151
91708078|NCT00482170|183309152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.024|TWO_SIDED|95.0|1.06|2.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.44|1.06|0.024
91708079|NCT00482170|183309152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.025|TWO_SIDED|95.0|1.06|2.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.39|1.06|0.025
91708080|NCT00482170|183309153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.49|0.24|<0.001
91708081|NCT00482170|183309153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.18|0.37||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.37|0.18|<0.001
91708082|NCT00482170|183309153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.45||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.45|0.21|<0.001
91774936|NCT00286468|183430801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5||||0.072|TWO_SIDED|95.0|-22.0|0.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.9|-22.0|0.072
91774937|NCT00286468|183430802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.775||||0.338|TWO_SIDED|95.0|0.46|1.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.306|0.460|0.338
91774938|NCT00286468|183430802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.521||||0.016|TWO_SIDED|95.0|0.306|0.887||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.887|0.306|0.016
91774939|NCT00286468|183430803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.374||||0.003|TWO_SIDED|95.0|0.194|0.72||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.720|0.194|0.003
91774940|NCT00286468|183430803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372||||0.003|TWO_SIDED|95.0|0.193|0.718||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.718|0.193|0.003
91774941|NCT00286468|183430804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.923|TWO_SIDED|95.0|-6.1|6.7||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-6.1|0.923
91774942|NCT00286468|183430804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.259|TWO_SIDED|95.0|-2.7|10.1||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||10.1|-2.7|0.259
91774943|NCT00286468|183430805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.916|TWO_SIDED|95.0|-6.6|5.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.9|-6.6|0.916
91774944|NCT00286468|183430805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.305|TWO_SIDED|95.0|-3.0|9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.5|-3.0|0.305
91774945|NCT00286468|183430806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.953|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.953
91774946|NCT00286468|183430806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.957|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.957
91774947|NCT00286468|183430807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.908|TWO_SIDED|95.0|-5.9|6.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.6|-5.9|0.908
91708083|NCT00482170|183309153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.47|0.23|<0.001
91774948|NCT00286468|183430807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.826|TWO_SIDED|95.0|-5.6|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-5.6|0.826
91774949|NCT00286468|183430808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.894|TWO_SIDED|95.0|-5.9|6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.8|-5.9|0.894
91774950|NCT00286468|183430808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.432|TWO_SIDED|95.0|-3.8|8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.9|-3.8|0.432
91774951|NCT00286468|183430809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.548|TWO_SIDED|95.0|-8.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-8.1|0.548
91774952|NCT00286468|183430809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.986|TWO_SIDED|95.0|-6.3|6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.2|-6.3|0.986
91774953|NCT00286468|183430810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.415|TWO_SIDED|95.0|-1.78|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.30|-1.78|0.415
91774954|NCT00286468|183430810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.332|TWO_SIDED|95.0|-1.54|4.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.55|-1.54|0.332
91774955|NCT00286468|183430811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.89|TWO_SIDED|95.0|-2.47|2.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.85|-2.47|0.890
91774956|NCT00286468|183430811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.38|TWO_SIDED|95.0|-1.48|3.86||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.86|-1.48|0.380
91774957|NCT00286468|183430812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35||||0.448|TWO_SIDED|95.0|-2.14|4.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.85|-2.14|0.448
91774958|NCT00286468|183430812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.568|TWO_SIDED|95.0|-2.48|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-2.48|0.568
91774959|NCT00286468|183430813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95||||0.077|TWO_SIDED|95.0|-0.32|6.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.22|-0.32|0.077
91520003|NCT00765388|182914143|SUPERIORITY_OR_OTHER|||||||0.4||0.0|||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.40
91520004|NCT00765388|182914144|SUPERIORITY_OR_OTHER|||||||0.64|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.64
91708084|NCT00482170|183309154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.27|0.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.54|0.27|<0.001
91710786|NCT00105989|183313983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91708085|NCT00482170|183309154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.21|<0.001
91710787|NCT00105989|183313984|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.015
91774960|NCT00286468|183430813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.303|TWO_SIDED|95.0|-1.55|4.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.99|-1.55|0.303
91774961|NCT00286468|183430814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.461|TWO_SIDED|95.0|-2.08|4.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.57|-2.08|0.461
91774962|NCT00286468|183430814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99||||0.559|TWO_SIDED|95.0|-2.34|4.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.32|-2.34|0.559
91774963|NCT00286468|183430815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.43|TWO_SIDED|95.0|-1.54|3.62||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.62|-1.54|0.430
91774964|NCT00286468|183430815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.124|TWO_SIDED|95.0|-0.56|4.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.61|-0.56|0.124
91774965|NCT00286468|183430816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056||||0.011|TWO_SIDED|95.0|-0.099|-0.013||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.013|-0.099|0.011
91774966|NCT00286468|183430816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.116|TWO_SIDED|95.0|-0.078|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.078|0.116
91774967|NCT00286468|183430817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.024|TWO_SIDED|95.0|-0.081|-0.006||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.006|-0.081|0.024
91774968|NCT00286468|183430817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.059|TWO_SIDED|95.0|-0.074|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.074|0.059
91774969|NCT00286468|183430818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.159|TWO_SIDED|95.0|-0.067|0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.011|-0.067|0.159
91774970|NCT00286468|183430818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.055|TWO_SIDED|95.0|-0.077|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.077|0.055
91774971|NCT00286468|183430819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.062|TWO_SIDED|95.0|-0.08|0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.002|-0.080|0.062
91774972|NCT00286468|183430819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.041|TWO_SIDED|95.0|-0.084|-0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.002|-0.084|0.041
91520005|NCT00765388|182914145|SUPERIORITY_OR_OTHER|||||||0.55|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.55
91774973|NCT00286468|183430820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.148|TWO_SIDED|95.0|-0.069|0.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.010|-0.069|0.148
91774974|NCT00286468|183430820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031||||0.135|TWO_SIDED|95.0|-0.071|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.071|0.135
91774975|NCT00286468|183430821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
91774976|NCT00286468|183430821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
91774977|NCT00286468|183430822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.324|TWO_SIDED|95.0|-0.161|0.486||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.486|-0.161|0.324
91774978|NCT00286468|183430822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.284|TWO_SIDED|95.0|-0.147|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.500|-0.147|0.284
91774979|NCT00286468|183430823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.053|TWO_SIDED|95.0|-0.004|0.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.540|-0.004|0.053
91774980|NCT00286468|183430823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349||||0.012|TWO_SIDED|95.0|0.077|0.621||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.621|0.077|0.012
91774981|NCT00286468|183430824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.196|TWO_SIDED|95.0|-0.094|0.458||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.458|-0.094|0.196
91774982|NCT00286468|183430824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226||||0.11|TWO_SIDED|95.0|-0.051|0.502||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.502|-0.051|0.110
91774983|NCT00286468|183430825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228||||0.121|TWO_SIDED|95.0|-0.06|0.517||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.517|-0.060|0.121
91774984|NCT00286468|183430825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.28|TWO_SIDED|95.0|-0.13|0.448||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.448|-0.130|0.280
91774985|NCT00286468|183430826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015||||0.924|TWO_SIDED|95.0|-0.29|0.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.320|-0.290|0.924
91774986|NCT00286468|183430826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138||||0.376|TWO_SIDED|95.0|-0.168|0.444||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.444|-0.168|0.376
91774987|NCT00286468|183430827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.642|TWO_SIDED|95.0|-0.242|0.393||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.393|-0.242|0.642
91774988|NCT00286468|183430827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063||||0.698|TWO_SIDED|95.0|-0.255|0.381||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.381|-0.255|0.698
91774989|NCT00286468|183430828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.596|TWO_SIDED|95.0|0.503|3.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.306|0.503|0.596
91774990|NCT00286468|183430828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.148|TWO_SIDED|95.0|0.787|4.885||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.885|0.787|0.148
91774991|NCT00286468|183430829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.925||||0.046|TWO_SIDED|95.0|1.011|3.666||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.666|1.011|0.046
91774992|NCT00286468|183430829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.505||||0.005|TWO_SIDED|95.0|1.313|4.78||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.780|1.313|0.005
91774993|NCT00286468|183430830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.025|TWO_SIDED|95.0|1.086|3.519||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.519|1.086|0.025
91774994|NCT00286468|183430830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.707|||<|0.001|TWO_SIDED|95.0|2.012|6.831||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.831|2.012|<0.001
91774995|NCT00286468|183430831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.994|||<|0.001|TWO_SIDED|95.0|1.72|5.213||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.213|1.720|<0.001
91774996|NCT00286468|183430831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.401|||<|0.001|TWO_SIDED|95.0|1.95|5.933||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.933|1.950|<0.001
91774997|NCT00286468|183430832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.115|TWO_SIDED|95.0|0.87|3.627||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.627|0.870|0.115
91774998|NCT00286468|183430832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.416|||<|0.001|TWO_SIDED|95.0|1.703|6.851||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.851|1.703|<0.001
91774999|NCT00286468|183430833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.991||||0.986|TWO_SIDED|95.0|0.365|2.689||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||2.689|0.365|0.986
91775000|NCT00286468|183430833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.131|TWO_SIDED|95.0|0.808|5.203||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.203|0.808|0.131
91775001|NCT00286468|183430834|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.626
91775002|NCT00286468|183430834|SUPERIORITY_OR_OTHER|||||||0.178||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.178
91775003|NCT00286468|183430835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.001|TWO_SIDED|95.0|0.32|1.16||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.16|0.32|<0.001
91775004|NCT00286468|183430835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.006|TWO_SIDED|95.0|0.17|1.02||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.02|0.17|0.006
91775005|NCT00286468|183430836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.006|TWO_SIDED|95.0|0.2|1.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.18|0.20|0.006
91775006|NCT00286468|183430836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.04|TWO_SIDED|95.0|0.02|1.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.01|0.02|0.040
91775007|NCT00286468|183430837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.47|1.73||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.73|0.47|<0.001
91775008|NCT00286468|183430837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.005|TWO_SIDED|95.0|0.28|1.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.55|0.28|0.005
91775009|NCT00286468|183430838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.018|TWO_SIDED|95.0|0.14|1.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|0.14|0.018
91775010|NCT00286468|183430838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.01|TWO_SIDED|95.0|0.21|1.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.54|0.21|0.010
91775011|NCT00072462|183430863|SUPERIORITY||Hazard Ratio (HR)|0.88|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|Univariate||||1.14|0.67|0.33
91775012|NCT00072462|183430863|SUPERIORITY||Hazard Ratio (HR)|0.87|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.66|1.15|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.15|0.66|0.33
91775013|NCT00072462|183430864|SUPERIORITY||Hazard Ratio (HR)|0.72|STANDARD_DEVIATION|0.12||0.06|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Univariate||||1.01|0.52|0.06
91775014|NCT00072462|183430864|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.13||0.09|TWO_SIDED|95.0|0.52|1.05|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.05|0.52|0.09
91775015|NCT00072462|183430865|SUPERIORITY||Hazard Ratio (HR)|1.64|STANDARD_DEVIATION|0.54||0.13|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Univariate||||2.84|0.75|0.13
91775016|NCT00072462|183430865|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_DEVIATION|0.5||0.26|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||2.84|0.75|0.26
91775017|NCT00072462|183430866|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.97|TWO_SIDED|95.0|0.21|5.11|||Regression, Cox|Univariate||||5.11|0.21|0.97
91775018|NCT00072462|183430866|SUPERIORITY||Hazard Ratio (HR)|1.08|STANDARD_DEVIATION|0.88||0.93|TWO_SIDED|95.0|0.22|5.36|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||5.36|0.22|0.93
91775019|NCT00072462|183430867|SUPERIORITY||Hazard Ratio (HR)|0.93|STANDARD_DEVIATION|0.17||0.67|TWO_SIDED|95.0|0.65|1.32|||Regression, Cox|Univariate||||1.32|0.65|0.67
91775020|NCT00072462|183430867|SUPERIORITY||Hazard Ratio (HR)|0.85|STANDARD_DEVIATION|0.16||0.38|TWO_SIDED|95.0|0.59|1.22|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.22|0.59|0.38
91775021|NCT02927301|183430884|SUPERIORITY||Other/Percentage|20.3|||<|0.0001|ONE_SIDED|95.0|14.9||||binomial test||||||14.900|<.0001
91775022|NCT02927301|183430885|SUPERIORITY||Risk Difference (RD)|11.41||||0.0358|ONE_SIDED|80.0|5.279||||Fisher Exact||||||5.279|0.0358
91775023|NCT02927301|183430886|SUPERIORITY||Risk Difference (RD)|16.363||||0.0395|ONE_SIDED|80.0|6.509||||Chi-squared||||||6.509|0.0395
91775024|NCT04742556|183430892|OTHER||Probability of true DLT rate in [0.33-1]|0.0051||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91775025|NCT04742556|183430892|OTHER||Probability of true DLT rate in [0.33-1]|0.03105||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91775026|NCT04742556|183430892|OTHER||Probability of true DLT rate in [0.33-1]|0.27405||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91775027|NCT03562195|183430918|SUPERIORITY||Posterior probablity|0.9999|||||||||||Bayesian Dynamic Borrowing|A BDB approach was used in the estimation of primary endpoint in the Chinese participants of this study, with information borrowed from MEA115588.|"Pr (rate ratio \<1 \| data)\>0.999. The 'positive result' is defined as if the posterior probability that the rate ratio is less than 1 is at least 0.95"|||||
91775028|NCT03562195|183430918|SUPERIORITY|The null hypothesis is defined as the rate ratio of events between Mepolizumab 100mg SC versus placebo is less than 1.|Rate Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Negative binomial model|||||0.50|0.24|<0.001
91775029|NCT02218372|183430937|OTHER||adjusted treatment difference|7.5|||||TWO_SIDED|95.0|-7.4|23.9||||||Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.||23.9|-7.4|
91520006|NCT00765388|182914146|SUPERIORITY_OR_OTHER|||||||0.48|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.48
91520007|NCT03923933|182914150|SUPERIORITY||||||<|0.001|||||||ANOVA|anova repeated measures||||||<0.001
91775030|NCT02218372|183430938|OTHER||adjusted treatment difference|16.3|||||TWO_SIDED|95.0|1.8|34.2||||||Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.2|1.8|
91775031|NCT02218372|183430939|OTHER||adjusted treatment difference|21.3|||||TWO_SIDED|95.0|4.5|37.7||||||Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||37.7|4.5|
91775032|NCT02218372|183430940|OTHER||adjusted treatment difference|-16.3|||||TWO_SIDED|95.0|-34.2|-1.8||||||Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.8|-34.2|
91520008|NCT03923933|182914151|SUPERIORITY|||||||0.006|||||||ANOVA|Repeated Measures||||||0.006
91520009|NCT03923933|182914152|SUPERIORITY|||||||0.371|||||||ANOVA|||||||0.371
91520010|NCT03923933|182914153|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91520011|NCT03923933|182914155|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
91775033|NCT02218372|183430941|OTHER||adjusted treatment difference|17.2|||||TWO_SIDED|95.0|1.9|35.6||||||Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.6|1.9|
91775034|NCT02218372|183430942|OTHER||adjusted treatment difference|19.4|||||TWO_SIDED|95.0|2.3|35.9||||||Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.9|2.3|
91775035|NCT02218372|183430943|OTHER||adjusted treatment difference|-17.2|||||TWO_SIDED|95.0|-35.6|-1.9||||||Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.9|-35.6|
91520012|NCT03923933|182914156|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
91775036|NCT02218372|183430944|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
91520013|NCT01995461|182914157|SUPERIORITY_OR_OTHER|||||||0.0252|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0252
91775037|NCT02218372|183430945|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
91775038|NCT02218372|183430946|OTHER||adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
91775039|NCT02218372|183430947|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
91520014|NCT01995461|182914158|SUPERIORITY_OR_OTHER|||||||0.0154|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0154
91520015|NCT01995461|182914159|SUPERIORITY_OR_OTHER|||||||0.1349|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.1349
91710788|NCT00105989|183313985|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
91775040|NCT02218372|183430948|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
91775041|NCT02218372|183430949|OTHER|Newcombe 95% CIs presented for adjusted treatment difference.|adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
91775042|NCT02218372|183430950|OTHER|||||||0.579|||||||Log Rank|||Time to resolution of diarrhea.||||0.579
91775043|NCT02218372|183430951|OTHER|||||||0.023|||||||Log Rank|||Time to recurrence of CDAD.||||0.023
91775044|NCT02923726|183430960|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.9|0.57|0.92|||Log Rank||Shock only was the reference group. Confidence interval adjusted for interim analyses.|||0.92|0.57|0.005
91775045|NCT02923726|183430961|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.284|TWO_SIDED|95.0|0.78|1.07|||Log Rank||Shock Only was the reference group.|||1.07|0.78|0.284
91775046|NCT02923726|183430962|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.56|0.95|||Log Rank||Shock Only arm is reference group.|||0.95|0.56|0.020
91775047|NCT02923726|183430963|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.033|TWO_SIDED|95.0|0.44|0.97|||Log Rank||Shock Only is the reference group.|||0.97|0.44|0.033
91775048|NCT02923726|183430964|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.184|TWO_SIDED|95.0|0.94|1.41|||Log Rank||Shock Only is the reference group.|||1.41|0.94|0.184
91646118|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6263|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.46|0.22|0.6263
91775049|NCT02753283|183430965|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.48||0.007|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.007
91775050|NCT02753283|183430965|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.09||0.018|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.018
91775051|NCT02753283|183430966|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|1.45||0.014|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.014
91775052|NCT02753283|183430966|SUPERIORITY||Mean Difference (Final Values)|5.16|STANDARD_ERROR_OF_MEAN|1.45||0.002|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.002
91775053|NCT02753283|183430967|SUPERIORITY||Mean Difference (Final Values)|2.54|STANDARD_ERROR_OF_MEAN|1.26||0.06|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.060
91775054|NCT02753283|183430967|SUPERIORITY||Mean Difference (Final Values)|2.45|STANDARD_ERROR_OF_MEAN|1.22||0.055|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.055
91775055|NCT02753283|183430968|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.37||0.112|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.112
91775056|NCT02753283|183430968|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|1.34||0.07|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.070
91775057|NCT02753283|183430969|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.39||0.904|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.904
91775058|NCT02753283|183430969|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.29||0.616|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.616
91775059|NCT02753283|183430970|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||<.001
91775060|NCT02753283|183430970|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.005|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.005
91775061|NCT02753283|183430971|SUPERIORITY||Mean Difference (Final Values)|-26.2|STANDARD_ERROR_OF_MEAN|6.0||0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.001
91646119|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.4122|TWO_SIDED|95.0|0.19|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.97|0.19|0.4122
91775062|NCT02753283|183430971|SUPERIORITY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|3.9||0.038|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.038
91775063|NCT02795117|183430987|EQUIVALENCE|provides 85% power of success|equivalence ratio|96.4|||||TWO_SIDED|90.0|91.0|105.4||No p-value was calculated for bioequivalence, only a T/R ratio and 90% confidence interval|ANOVA|||||105.4|91.0|
91775064|NCT02795117|183430988|EQUIVALENCE|provides 85% power of success|Equivalence difference|-6.48|||||TWO_SIDED|90.0|-18.31|1.85|||Wald's method|||||1.85|-18.31|
91775065|NCT02546609|183430996|OTHER|||||||0.0572|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.0572
91775066|NCT02546609|183430996|OTHER|||||||0.377|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.3770
91775067|NCT02546609|183430997|OTHER|||||||0.3811|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3811
91646120|NCT01236053|183184665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.2642|TWO_SIDED|95.0|0.16|1.66|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.66|0.16|0.2642
91775068|NCT02546609|183430997|OTHER|||||||0.8479|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8479
91775069|NCT02546609|183430998|OTHER|||||||0.7742|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.7742
91646121|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.7891|TWO_SIDED|95.0|0.31|2.43|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.43|0.31|0.7891
91775070|NCT02546609|183430998|OTHER|||||||0.6666|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6666
91775071|NCT02546609|183430999|OTHER|||||||0.002|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0020
91775072|NCT02546609|183430999|OTHER|||||||0.0164|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0164
91775073|NCT02546609|183431000|OTHER|||||||0.4099|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4099
91775074|NCT02546609|183431000|OTHER|||||||0.1455|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.1455
91775075|NCT02546609|183431001|OTHER|||||||0.2559|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2559
91775076|NCT02546609|183431001|OTHER|||||||0.9776|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.9776
91775077|NCT02546609|183431002|OTHER|||||||0.2265|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2265
91775078|NCT02546609|183431002|OTHER|||||||0.8366|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8366
91775079|NCT02546609|183431003|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
91775080|NCT02546609|183431003|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
91613890|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379|||<|0.0001|TWO_SIDED|95.0|1.236|1.538|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.538|1.236|<0.0001
91775081|NCT02546609|183431004|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
91775082|NCT02546609|183431004|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
91775083|NCT02546609|183431005|OTHER|||||||0.0129|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0129
91775084|NCT02546609|183431005|OTHER|||||||0.4316|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4316
91775085|NCT02546609|183431006|OTHER|MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||||0.1946|||||||MMRM|||||||0.1946
91775086|NCT02546609|183431006|OTHER|||||||0.4697|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4697
91775087|NCT02546609|183431007|OTHER|||||||0.3474|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3474
91775088|NCT02546609|183431007|OTHER|||||||0.8832|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8832
91775089|NCT02212015|183431008|OTHER||Rate|0.46|||||TWO_SIDED|||||||||Question is, if 6 months progression free survival rate (PFS-R) denoted by pPFS is higher than 35%. Test hypothesis is thus formulated as: H0: pPFS ≤0.35 versus H1: pPFS ≥0.35. This hypothesis is tested at the one-side significance level of 0.05. A 6 months PFS-R of 0.55 of cases or more is considered as clinically relevant success rate. The design is chosen such that rates of 0.55 or higher can be detected with a power of at least 0.8.||||
91775090|NCT02212015|183431009|SUPERIORITY||Rate difference|0.486|||||TWO_SIDED|||||||||||||
91775091|NCT02212015|183431010|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|||||||||||||
91775092|NCT02212015|183431011|OTHER||Median|21.6|||||TWO_SIDED|||||||||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||
91775093|NCT02212015|183431012|SUPERIORITY|||||||0.752|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 1 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.752
91775094|NCT02212015|183431013|SUPERIORITY|||||||0.621|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 2 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.621
91775095|NCT02212015|183431014|OTHER||||||||||||||||||Frequency of each category is given|||
91775096|NCT02212015|183431015|SUPERIORITY|||||||0.349|||||||Chi squared test, exact|||Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies. Categories of BOR are CR, PR, SD, PD and NE)|Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies applied to the total of 26 enrolled subjects.. Categories of BOR are CR, PR, SD, PD and NE).|||0.349
91775097|NCT02212015|183431016|SUPERIORITY|||||||0.385|||||||Chi squared test, exact|||||||0.385
91775098|NCT00659061|183431044|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||at baseline|Chi-squared|||||||0.32
91775099|NCT00659061|183431044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||at endline|Chi-squared|||||||<0.001
91775100|NCT00659061|183431046|SUPERIORITY_OR_OTHER||||||<|0||95.0|||||ANOVA|adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)||||||<0.000
91775101|NCT00659061|183431047|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||baseline|Chi-squared|||||||0.34
91775102|NCT00659061|183431047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||endline|Chi-squared|||||||<0.001
91775103|NCT00659061|183431048|SUPERIORITY_OR_OTHER|||||||0||95.0||||endline|ANOVA|adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement||||||0.000
91775104|NCT00659061|183431049|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||baseline|Chi-squared|||||||0.7
91775105|NCT00659061|183431049|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||endline|Chi-squared|||||||0.02
91775106|NCT00659061|183431050|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||baseline|Chi-squared|||||||0.62
91775107|NCT00659061|183431050|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||endline|Chi-squared|||||||0.89
91775108|NCT00659061|183431051|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||baseline|Chi-squared|||||||0.93
91775109|NCT00659061|183431051|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||endline|Chi-squared|||||||0.49
91775110|NCT01168349|183431093|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55|||||TWO_SIDED|95.0|0.42|0.71||||||||0.71|0.42|
91775111|NCT01168349|183431096|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91775112|NCT02005016|183431146|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).|||||<|0.005|||||||t-test, 1 sided|||||||<0.005
91775113|NCT02005016|183431147|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91775114|NCT01323582|183431166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|11.7||0.76|TWO_SIDED|95.0|-21.5|28.6|||t-test, 2 sided|Satterthwaite corrected t-test was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||28.6|-21.5|0.76
91775115|NCT01323582|183431167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65||95.0|-4.8|7.5|||t-test, 2 sided|Satterthwaite Correction used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||7.5|-4.8|0.65
91775116|NCT01323582|183431168|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.3||0.88|TWO_SIDED|95.0|-4.58|5.19|||t-test, 2 sided|Satterthwaite correction for unequal standard deviations was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Half of the period 2 minus period 1 differences were used, since the difference between these two derived means is an unbiased estimate of the effect size.||5.19|-4.58|0.88
91775117|NCT01323582|183431169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|5.7||0.8|TWO_SIDED|95.0|-13.9|10.9|||t-test, 2 sided|Satterthwaite Corrected t-test|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|||10.9|-13.9|0.80
91775118|NCT01323582|183431170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.8|STANDARD_ERROR_OF_MEAN|9.1||0.21|TWO_SIDED|95.0|-30.9|7.3|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||7.3|-30.9|0.21
91775119|NCT01323582|183431171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|STANDARD_ERROR_OF_MEAN|6.61||0.034|TWO_SIDED|95.0|-28.7|-1.26|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||-1.26|-28.7|0.034
91775120|NCT01323582|183431172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|STANDARD_ERROR_OF_MEAN|1.98||0.015|TWO_SIDED|95.0|-9.48|-1.16|||t-test, 2 sided||Lower scores are favorable.|||-1.16|-9.48|0.015
91775121|NCT01323582|183431173|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.4|STANDARD_ERROR_OF_MEAN|2.2||0.0083|TWO_SIDED|95.0|-10.97|-1.83|||t-test, 2 sided||Lower scores are favorable.|||-1.83|-10.97|0.0083
91775122|NCT00525512|183431186|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.1062||95.0|0.97|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|0.97|0.1062
91775123|NCT00525512|183431187|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.008||95.0|1.03|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.23|1.03|0.008
91775124|NCT00525512|183431188|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.1||||0.0597||95.0|1.0|1.21||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.21|1.00|0.0597
91775125|NCT00525512|183431189|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.15||||0.0131||95.0|1.03|1.29||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.29|1.03|0.0131
91775126|NCT00525512|183431190|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.18||||0.0041||95.0|1.05|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|1.05|0.0041
91775127|NCT00525512|183431191|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.11||||0.0945||95.0|0.98|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|0.98|0.0945
91775128|NCT00525512|183431192|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.0899||95.0|0.98|1.28||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.28|0.98|0.0899
91775129|NCT00525512|183431193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|||<|0.0001||95.0|0.073|0.16||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.160|0.073|<0.0001
91775130|NCT00525512|183431194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082||||0.0005||95.0|0.036|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.036|0.0005
91775131|NCT00525512|183431195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.0003||95.0|0.041|0.137||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.137|0.041|0.0003
91775132|NCT00525512|183431196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|||<|0.0001||95.0|0.058|0.153||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.153|0.058|<0.0001
91775133|NCT00525512|183431197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0005||95.0|0.04|0.141||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.141|0.040|0.0005
91775134|NCT00525512|183431198|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.094||||0.0002||95.0|0.045|0.144||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.144|0.045|0.0002
91775135|NCT00525512|183431199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.0059||95.0|0.022|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.022|0.0059
91775136|NCT00525512|183431200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.11|0.198||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.198|0.110|<0.0001
91710789|NCT00105989|183313986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91710790|NCT00105989|183313987|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.032
91775137|NCT00525512|183431201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.117|0.208||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.208|0.117|<0.0001
91775138|NCT00525512|183431202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.099|0.192||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.192|0.099|<0.0001
91775139|NCT00525512|183431203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|||<|0.0001||95.0|0.077|0.176||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.176|0.077|<0.0001
91775140|NCT00525512|183431204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.0001||95.0|0.083|0.185||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.185|0.083|<0.0001
91775141|NCT00525512|183431205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|||<|0.0001||95.0|0.097|0.202||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.202|0.097|<0.0001
91775142|NCT00525512|183431206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.0001||95.0|0.077|0.183||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.183|0.077|<0.0001
91775143|NCT00525512|183431207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|||<|0.0001||95.0|0.127|0.307||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.307|0.127|<0.0001
91775144|NCT00525512|183431208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.0019||95.0|0.058|0.255||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.255|0.058|0.0019
91775145|NCT00525512|183431209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.0006||95.0|0.078|0.286||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.286|0.078|0.0006
91775146|NCT00525512|183431210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|||<|0.0001||95.0|0.13|0.339||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.339|0.130|<0.0001
91775147|NCT00525512|183431211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161||||0.009||95.0|0.04|0.281||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.281|0.040|0.009
91775148|NCT00525512|183431212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212||||0.0002||95.0|0.102|0.322||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.322|0.102|0.0002
91775149|NCT00525512|183431213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||<|0.0001||95.0|0.128|0.355||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.355|0.128|<0.0001
91775150|NCT00525512|183431214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|||<|0.0001||95.0|0.179|0.375||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.375|0.179|<0.0001
91775151|NCT00525512|183431215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||<|0.0001||95.0|0.226|0.425||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.425|0.226|<0.0001
91775152|NCT00525512|183431216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|||<|0.0001||95.0|0.245|0.461||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.461|0.245|<0.0001
91775153|NCT00525512|183431217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|||<|0.0001||95.0|0.154|0.365||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.365|0.154|<0.0001
91775154|NCT00525512|183431218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.0001||95.0|0.194|0.406||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.406|0.194|<0.0001
91775155|NCT00525512|183431219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|||<|0.0001||95.0|0.144|0.364||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.364|0.144|<0.0001
91775156|NCT00525512|183431220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||<|0.0001||95.0|0.209|0.456||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.456|0.209|<0.0001
91775157|NCT00525512|183431221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.1131||95.0|-0.72|0.08||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.08|-0.72|0.1131
91775158|NCT00525512|183431222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9071||95.0|-0.38|0.33||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.33|-0.38|0.9071
91775159|NCT00525512|183431223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.6878||95.0|-0.35|0.53||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.53|-0.35|0.6878
91775160|NCT00525512|183431224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||||95.0|-2.39|3.11||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.11|-2.39|
91775161|NCT00525512|183431225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||||95.0|-2.66|3.31||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.31|-2.66|
91775162|NCT00525512|183431226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||||95.0|-2.91|3.58||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.58|-2.91|
91775163|NCT00525512|183431227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-2.97|3.43||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.43|-2.97|
91775164|NCT00525512|183431228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||||95.0|-3.02|3.46||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.46|-3.02|
91775165|NCT00525512|183431229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||||95.0|-3.1|3.41||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.41|-3.10|
91775166|NCT00525512|183431230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||||95.0|-3.22|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.22|
91520016|NCT01939548|182914180|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.11|STANDARD_ERROR_OF_MEAN|2.409||0.1991|TWO_SIDED|80.0|0.01|6.21||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||6.21|0.01|0.1991
91646122|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6216|TWO_SIDED|95.0|0.27|2.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.17|0.27|0.6216
91775167|NCT00525512|183431231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||||95.0|-2.78|3.52||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.52|-2.78|
91775168|NCT00525512|183431232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-3.05|3.51||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.51|-3.05|
91775169|NCT00525512|183431233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||||95.0|-3.4|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.40|
91775170|NCT00525512|183431234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||||95.0|-3.61|3.92||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.92|-3.61|
91775171|NCT00525512|183431235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.53|3.9||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.90|-3.53|
91775172|NCT00525512|183431236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.36|3.71||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.71|-3.36|
91775173|NCT00525512|183431237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||||95.0|-3.82|3.96||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.96|-3.82|
91775174|NCT00525512|183431238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03||||0.0072||95.0|-6.97|-1.1||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-1.10|-6.97|0.0072
91775175|NCT00525512|183431239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.2029||95.0|-5.91|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|-5.91|0.2029
91775176|NCT00525512|183431240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.0313||95.0|-6.84|-0.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-0.32|-6.84|0.0313
91775177|NCT00525512|183431241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.94||||0.0001||95.0|-13.37|-4.52||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-4.52|-13.37|0.0001
91775178|NCT00525512|183431242|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.6541||95.0|0.719|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Regression, Cox|||||1.230|0.719|0.6541
91775179|NCT00525512|183431243|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.06||||0.4443||95.0|0.91|1.25||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||1.25|0.91|0.4443
91775180|NCT00525512|183431244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8644||95.0|-0.05|0.06||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.06|-0.05|0.8644
91775181|NCT00525512|183431245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.4277||95.0|-0.07|0.17||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.17|-0.07|0.4277
91775182|NCT00525512|183431246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.7071||95.0|-3.81|2.59||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||2.59|-3.81|0.7071
91775183|NCT00525512|183431247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.6556||95.0|-3.03|4.81||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||4.81|-3.03|0.6556
91775184|NCT00525512|183431248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9896||95.0|-3.44|3.48||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||3.48|-3.44|0.9896
91775185|NCT00525512|183431249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.0807||95.0|-9.19|0.53||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.53|-9.19|0.0807
91775186|NCT01601535|183431269|OTHER|||||||0.14||||||MYCN Amplified vs. MYCN not Amplified|Fisher Exact|||||||0.14
91775187|NCT01601535|183431269|OTHER|||||||0.21|||||||Fisher Exact|MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative||||||0.21
91775188|NCT01601535|183431269|OTHER|||||||1|||||||Fisher Exact|Aurora A protein Positive vs. Aurora A protein Negative||||||1.0
91775189|NCT01601535|183431270|OTHER|||||||0.094||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.094
91775190|NCT01601535|183431270|OTHER|||||||0.63||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.63
91775191|NCT01601535|183431271|OTHER|||||||0.9||||||AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W|Fisher Exact|||||||0.90
91775192|NCT01601535|183431271|OTHER|||||||1||||||AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W|Fisher Exact|||||||1.0
91775193|NCT00534365|183431273|NON_INFERIORITY_OR_EQUIVALENCE|We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.||||||0.43|||||||Regression, Logistic|||||||0.43
91775194|NCT00534365|183431276|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
91775195|NCT00534365|183431277|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||||||0.015
91775196|NCT04576988|183431279|OTHER||Treatment difference|40.8|||<|0.001|TWO_SIDED|95.0|27.53|54.14||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|Aligned Rank Stratified Wilcoxon (ARSW)|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% confidence interval (CI) was reported.|||54.14|27.53|<0.001
91775197|NCT04576988|183431282|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
91775198|NCT04576988|183431283|OTHER||Treatment difference|-234.6|||<|0.001|TWO_SIDED|95.0|-288.37|-180.75||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-180.75|-288.37|<0.001
91775199|NCT04576988|183431284|OTHER||Treatment difference|-441.6|||<|0.001|TWO_SIDED|95.0|-573.54|-309.61||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-309.61|-573.54|<.001
91775200|NCT04576988|183431285|OTHER|A 2-sided p-value was calculated using CMH method with WHO FC II/III and background PAH therapy as strata.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91775201|NCT04576988|183431286|OTHER|A 2-sided p-value was calculated using Log rank test with WHO FC II/III and background PAH therapy as strata.|Hazard Ratio (HR)|0.163|||<|0.001|TWO_SIDED|95.0|0.076|0.347|||Log Rank||Cox proportional hazard model was used to generate hazard ratio (HR) and 95% CI was reported with treatment group as the covariate stratified by the WHO FC II/III and background PAH therapy.|||0.347|0.076|<0.001
91775202|NCT04576988|183431287|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
91775203|NCT04576988|183431288|OTHER||Treatment difference|-0.26||||0.01|TWO_SIDED|95.0|-0.49|-0.04||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.040|-0.490|0.010
91775204|NCT04576988|183431289|OTHER||Treatment difference|-0.13||||0.028|TWO_SIDED|95.0|-0.256|-0.014||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.014|-0.256|0.028
91775205|NCT04576988|183431290|OTHER||Treatment difference|-0.16||||0.156|TWO_SIDED|95.0|-0.399|0.084||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||0.084|-0.399|0.156
91775206|NCT02919761|183431306|OTHER||||||=|0.242||||||At Week 4|One-sample binomial test|||||||=0.242
91613891|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.033||||0.0251|TWO_SIDED|95.0|1.004|1.063|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|1.004|0.0251
91775207|NCT02919761|183431306|OTHER||||||<|0.0001||||||At Week 8|One-sample binomial test|||||||<0.0001
91710791|NCT00105989|183313988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91775208|NCT02919761|183431306|OTHER||||||<|0.0001|||||||One-sample binomial test|||||||<0.0001
91775209|NCT02919761|183431307|OTHER||||||=|0.313||||||Comparison at Week 12|Pearson's Chi-square test|||||||=0.313
91775210|NCT02919761|183431307|OTHER||||||=|0.439||||||Comparison at Week 16|Pearson's Chi-square test|||||||=0.439
91775211|NCT02919761|183431307|OTHER||||||=|0.028||||||Comparison at Week 20|Pearson's Chi-square test|||||||=0.028
91775212|NCT02919761|183431307|OTHER||||||=|0.019||||||Comparison at Week 24|Pearson's Chi-square test|||||||=0.019
91775213|NCT02994108|183431330|SUPERIORITY||Chi-Square|0.415||||0.601|TWO_SIDED||||||Chi-squared|||||||.601
91775214|NCT02994108|183431331|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.249|TWO_SIDED||||||t-test, 2 sided|||||||.249
91775215|NCT02994108|183431332|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.675|TWO_SIDED||||||t-test, 2 sided|||||||.675
91775216|NCT02994108|183431333|SUPERIORITY||Odds Ratio (OR)|3.43||||0.025|TWO_SIDED|95.0|1.17|10.08|||Regression, Logistic|||||10.08|1.17|.025
91775217|NCT02994108|183431334|SUPERIORITY||Odds Ratio (OR)|1.14||||0.923|TWO_SIDED|95.0|0.08|16.95|||Regression, Logistic|||||16.95|0.08|.923
91775218|NCT02994108|183431335|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.174|TWO_SIDED||||||t-test, 2 sided|||||||.174
91775219|NCT02994108|183431336|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||.002
91775220|NCT02994108|183431337|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.964|TWO_SIDED||||||t-test, 2 sided|||||||.964
91775221|NCT02994108|183431338|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||.053
91775222|NCT02994108|183431339|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.183|TWO_SIDED||||||t-test, 2 sided|||||||.183
91775223|NCT02994108|183431340|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.064|TWO_SIDED||||||t-test, 2 sided|||||||.064
91775224|NCT02994108|183431341|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.147|TWO_SIDED||||||t-test, 2 sided|||||||.147
91775225|NCT02994108|183431342|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.096|TWO_SIDED||||||t-test, 2 sided|||||||.096
91775226|NCT02994108|183431343|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.013|TWO_SIDED||||||t-test, 2 sided|||||||.013
91710792|NCT00105989|183313989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
91775227|NCT01295814|183431389|NON_INFERIORITY_OR_EQUIVALENCE|"The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.~The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12."|Mean Difference (Final Values)|7.9||||0.75|TWO_SIDED|95.0|4.0|11.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||11.8|4.0|0.75
91775228|NCT01295814|183431390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.99|TWO_SIDED|95.0|1.7|6.3||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||6.3|1.7|0.99
91775229|NCT01295814|183431391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.76|TWO_SIDED|95.0|2.1|5.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||5.8|2.1|0.76
91775230|NCT01295814|183431392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.76|TWO_SIDED|95.0|2.6|10.0||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||10.0|2.6|0.76
91775231|NCT01295814|183431393|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided|||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||||0.67
91775232|NCT03414983|183431394|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|80.0|0.61|1.07||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.07|0.61|0.3022
91775233|NCT03414983|183431394|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|95.0|0.53|1.23||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.23|0.53|0.3022
91775234|NCT03414983|183431395|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.19|0.54|
91775235|NCT03414983|183431410|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|80.0|0.67|1.15||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.15|0.67|0.5041
91775236|NCT03414983|183431410|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|95.0|0.58|1.32||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.32|0.58|0.5041
91775237|NCT02535481|183431432|SUPERIORITY|||||||0.366||||||At 6 weeks|Fisher Exact|||||||0.366
91775238|NCT02535481|183431432|SUPERIORITY|||||||0.24||||||At 3 months|Fisher Exact|||||||0.24
91775239|NCT02535481|183431433|SUPERIORITY||||||<|0.0001|||||||Log Rank|Kaplan-Meier analysis of cumulative wound healing followed by a log rank test||||||<0.0001
91775240|NCT02535481|183431434|SUPERIORITY|||||||0.12|||||||Log Rank|||||||0.12
91775241|NCT02535481|183431435|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91775242|NCT02535481|183431436|SUPERIORITY|||||||0.001||||||At 6 weeks|Wilcoxon (Mann-Whitney)|||||||0.001
91775243|NCT02535481|183431436|SUPERIORITY|||||||0.001||||||At 3 months|Wilcoxon (Mann-Whitney)|||||||0.001
91775244|NCT00248625|183431486|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.19
91775245|NCT00248625|183431487|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
91775246|NCT00248625|183431488|SUPERIORITY_OR_OTHER|||||||0.21|||||||Pepe and Mori test of CIF difference|||||||0.21
91775247|NCT00248625|183431489|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Kruskal-Wallis|||||||0.053
91775248|NCT00248625|183431490|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Cochran-Armitage trend|||||||0.29
91775249|NCT00248625|183431491|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Armitage trend|||||||0.74
91775250|NCT00248625|183431492|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Cochran-Armitage tren|||||||0.54
91775251|NCT00248625|183431493|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Chi-squared|||||||0.86
91775252|NCT00904943|183431494|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|104.27|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Mean falls within 80-125.|||||
91775253|NCT00904943|183431495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|102.35|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
91520017|NCT01939548|182914180|SUPERIORITY_OR_OTHER||LSM Difference|2.3|STANDARD_ERROR_OF_MEAN|2.445||0.3488|TWO_SIDED|80.0|-0.85|5.45||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||5.45|-0.85|0.3488
91520018|NCT01939548|182914181|SUPERIORITY_OR_OTHER||LSM Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.476||0.8786|TWO_SIDED|80.0|-2.13|1.67||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.67|-2.13|0.8786
91775254|NCT00904943|183431496|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|103.66|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
91775255|NCT03085095|183431497|NON_INFERIORITY|The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.|Treatment difference|7.9|||||TWO_SIDED|95.0|4.1|11.8|||||Treatment difference= Relugolix - Leuprolide acetate|Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.||11.8|4.1|
91775256|NCT03085095|183431497|SUPERIORITY|If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.|||||<|0.0001|||||||t-test, 2 sided|Two-sided type I error of 0.05.||Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.||||< 0.0001
91775257|NCT03085095|183431498|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
91775258|NCT03085095|183431499|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
91775259|NCT03085095|183431500|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|Cochran-Mantel-Haenszel|||Alpha-protected statistical analysis.||||< 0.0001
91775260|NCT03085095|183431501|SUPERIORITY||Treatment difference|77.41|||<|0.0001|TWO_SIDED|95.0|73.98|80.83||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.|Treatment difference= Relugolix - Leuprolide acetate|Alpha-protected statistical analysis.||80.83|73.98|< 0.0001
91775261|NCT03085095|183431502|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
91646123|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.6893|TWO_SIDED|95.0|0.31|5.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.96|0.31|0.6893
91775262|NCT03085095|183431506|OTHER||Treatment difference|13.0|||||TWO_SIDED|95.0|6.9|19.1|||||Treatment difference= Relugolix - Leuprolide acetate|||19.1|6.9|
91775263|NCT03085095|183431508|OTHER||Treatment difference|-2.9|||||TWO_SIDED|95.0|-7.8|2.0|||||Treatment difference= Relugolix - Leuprolide acetate|||2.0|-7.8|
91775264|NCT03284710|183431524|OTHER|||||||0.358||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.358
91775265|NCT03284710|183431524|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||1.000
91775266|NCT03284710|183431524|OTHER|||||||0.361||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.361
91775267|NCT03284710|183431525|OTHER|||||||0.238||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.238
91775268|NCT03284710|183431525|OTHER|||||||0.893||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||0.893
91775269|NCT03284710|183431525|OTHER|||||||0.411||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.411
91775270|NCT03284710|183431526|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||1.000
91775271|NCT03284710|183431526|OTHER|||||||0.044||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.044
91775272|NCT03284710|183431526|OTHER|||||||0.045||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.045
91775273|NCT03284710|183431527|OTHER|||||||0.215||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||0.215
91775274|NCT03284710|183431527|OTHER|||||||0.683||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.683
91775275|NCT03284710|183431527|OTHER|||||||0.322||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.322
91775276|NCT05543265|183431575|SUPERIORITY||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|6.4|28.8|||Chi-squared|||||28.8|6.4|<0.001
91646124|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.9273|TWO_SIDED|95.0|0.24|4.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.84|0.24|0.9273
91646125|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.598|TWO_SIDED|95.0|0.47|3.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.78|0.47|0.5980
91646126|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8572|TWO_SIDED|95.0|0.38|3.18|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.18|0.38|0.8572
91775277|NCT04090203|183431627|SUPERIORITY||Percentage|75.0||||0.001|ONE_SIDED|95.0|40.0|||The test was performed at a one-sided significance level of 0.05.|Exact binomial test|The null hypothesis of the exact binomial test was that the percentage of patients who were successfully desensitized was less than or equal to 20%.|The percentage of successfully desensitized participants is presented with a one-sided 95% CI, obtained from the lower bound of the two-sided 90% Clopper-Pearson exact confidence interval.|The null hypothesis was that the percentage of patients who were successfully desensitized was less than or equal to 20%, and the alternative hypothesis was that this percentage was greater than 20%. Assuming 80% of study participants would be successfully desensitized, a sample size of 10 patients would provide greater than 90% power to reject the null hypothesis using a one-sided exact binomial test with a significance level of 0.05.|||40.0|0.001
91775278|NCT01488045|183431634|EQUIVALENCE|We compared patient satisfaction for those receiving the 2 sedation regimens using the Schuirmann 2 one-sided t test procedure.15 The groups were declared to be equivalent in terms of patient satisfaction if the 90% CI for the difference in mean satisfaction had outer boundaries indicating \<5% difference on the 100-point VAS. Nonequivalence was declared if the lower 90% CI boundary for the difference was less than -5.0, or if the upper 90% CI boundary for the difference was \>5.0.|Mean Difference (Final Values)|-14.0741|STANDARD_DEVIATION|22.2|||TWO_SIDED|95.0|-18.5|-9.6||||||To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.||-9.6|-18.5|
91775279|NCT02587221|183431656|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|19.8|||||TWO_SIDED|97.45|-5.27|38.91|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||38.91|-5.27|
91775280|NCT02587221|183431661|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as the presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|32.12|||||TWO_SIDED|95.0|10.23|48.67|||Regression, Cox|Adjusted for covariates||||48.67|10.23|
91775281|NCT02587221|183431662|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the vaccine strains.~An ILI was defined as the presence of ≥1 respiratory symptom (eg. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|49.94|||||TWO_SIDED|95.0|-24.03|79.79|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||79.79|-24.03|
91775282|NCT02587221|183431663|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|61.5|||||TWO_SIDED|95.0|-7.98|86.28|||Regression, Cox|Adjusted for covariates||||86.28|-7.98|
91775283|NCT02587221|183431664|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any vaccine strain regardless of antigenic match.~An ILI was defined as the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|28.66|||||TWO_SIDED|95.0|0.05|49.08|||Regression, Cox|Adjusted for covariates||||49.08|0.05|
91775284|NCT02587221|183431665|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|33.47|||||TWO_SIDED|95.0|2.56|54.57|||Regression, Cox|Adjusted for covariates||||54.57|2.56|
91775285|NCT02587221|183431666|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the vaccine strains.~An ILI is the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|23.79|||||TWO_SIDED|95.0|-9.69|47.05|||Regression, Cox|Adjusted for covariates||||47.05|-9.69|
91646127|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7807|TWO_SIDED|95.0|0.26|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.77|0.26|0.7807
91775286|NCT02587221|183431667|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|26.11|||||TWO_SIDED|95.0|-11.71|51.13|||Regression, Cox|Adjusted for covariates||||51.13|-11.71|
91775287|NCT02587221|183431672|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|51.08|||||TWO_SIDED|95.0|28.21|66.67|||Regression, Cox|Adjusted for covariates||||66.67|28.21|
91775288|NCT02587221|183431673|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)"|Vaccine efficacy (VE)|74.96|||||TWO_SIDED|95.0|-17.93|94.68|||Regression, Cox|Adjusted for covariates||||94.68|-17.93|
91775289|NCT02587221|183431674|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|60.17|||||TWO_SIDED|95.0|31.19|76.94|||Regression, Cox|Adjusted for covariates||||76.94|31.19|
91775290|NCT02587221|183431675|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|57.02|||||TWO_SIDED|95.0|22.73|76.09|||Regression, Cox|Adjusted for covariates||||76.09|22.73|
91775291|NCT03988400|183431676|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
91775292|NCT03988400|183431677|SUPERIORITY|||||||0.017||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.017
91775293|NCT03988400|183431678|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
91775294|NCT03988400|183431679|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.72
91775295|NCT03988400|183431680|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.001
91775296|NCT03988400|183431681|SUPERIORITY|||||||0.68||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.68
91775297|NCT03988400|183431682|SUPERIORITY|||||||0.25||||||The a priori threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.25
91775298|NCT03988400|183431683|SUPERIORITY|||||||0.69||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.69
91775299|NCT03988400|183431684|SUPERIORITY|||||||0.2||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.20
91775300|NCT03988400|183431685|SUPERIORITY|||||||0.62||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.62
91775301|NCT04913610|183431687|OTHER||||||=|0.036|||||||Mann-Whitney U test|The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.036
91775302|NCT04913610|183431687|OTHER||||||=|0.53||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.530
91775303|NCT04913610|183431687|OTHER||||||=|0.852||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.852
91646128|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.5579|TWO_SIDED|95.0|0.21|2.32|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.32|0.21|0.5579
91775304|NCT04913610|183431687|OTHER||||||=|0.366||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.366
91775305|NCT04913610|183431688|OTHER||||||=|0.869||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.869
91775306|NCT04913610|183431688|OTHER||||||=|0.973||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.973
91775307|NCT04913610|183431688|OTHER||||||=|0.744||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.744
91775308|NCT04913610|183431688|OTHER||||||=|0.794||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.794
91646129|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.4|2.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.53|0.40|0.9932
91646130|NCT01236053|183184666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6901|TWO_SIDED|95.0|0.32|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.11|0.32|0.6901
91646131|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.431|TWO_SIDED|95.0|0.19|2.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.01|0.19|0.4310
91708086|NCT00482170|183309154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
91646132|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.3226|TWO_SIDED|95.0|0.17|1.79|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.79|0.17|0.3226
91646133|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.6206|TWO_SIDED|95.0|0.4|4.59|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.59|0.40|0.6206
91646134|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8557|TWO_SIDED|95.0|0.33|3.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.84|0.33|0.8557
91775309|NCT04913610|183431689|OTHER||||||=|0.559||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.559
91646135|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1498|TWO_SIDED|95.0|0.79|4.62|||Unadjusted Odds Ratio||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.62|0.79|0.1498
91646136|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.2645|TWO_SIDED|95.0|0.68|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.07|0.68|0.2645
91775310|NCT04913610|183431689|OTHER||||||=|0.786||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.786
91708087|NCT00482170|183309154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
91646137|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.5728|TWO_SIDED|95.0|0.16|2.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.79|0.16|0.5728
91646138|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.3727|TWO_SIDED|95.0|0.12|2.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.21|0.12|0.3727
91646139|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7743|TWO_SIDED|95.0|0.31|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.40|0.31|0.7743
91646140|NCT01236053|183184668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.4775|TWO_SIDED|95.0|0.24|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.94|0.24|0.4775
91646141|NCT01236053|183184669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.0032|TWO_SIDED|95.0|1.95|27.56|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||27.56|1.95|0.0032
91646142|NCT01236053|183184669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.1251|TWO_SIDED|95.0|0.71|16.17|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||16.17|0.71|0.1251
91646143|NCT01236053|183184669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0261|TWO_SIDED|95.0|1.15|9.01|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||9.01|1.15|0.0261
91646144|NCT01236053|183184669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.209|TWO_SIDED|95.0|0.65|7.17|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.17|0.65|0.2090
91646145|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
91646146|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
91646147|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
91646148|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21||||0.0269|TWO_SIDED|95.0|1.21|22.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||22.51|1.21|0.0269
91646149|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
91646150|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
91775311|NCT04913610|183431689|OTHER||||||=|0.423||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.423
91775312|NCT04913610|183431689|OTHER||||||=|0.92||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.920
91775313|NCT04913610|183431690|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
91775314|NCT04913610|183431690|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
91775315|NCT04913610|183431690|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
91775316|NCT04913610|183431690|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
91775317|NCT04913610|183431691|OTHER||||||=|0.157||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.157
91775318|NCT04913610|183431691|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
91775319|NCT04913610|183431691|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
91775320|NCT04913610|183431691|OTHER||||||=|0.173||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.173
91775321|NCT04913610|183431692|OTHER||||||=|0.619||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.619
91775322|NCT04913610|183431692|OTHER||||||=|0.194||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.194
91775323|NCT04913610|183431692|OTHER||||||=|0.518||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.518
91775324|NCT04913610|183431692|OTHER||||||=|0.652||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.652
91775325|NCT04913610|183431693|OTHER||||||=|0.386||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.386
91520019|NCT01939548|182914181|SUPERIORITY_OR_OTHER||LSM Difference|-1.14|STANDARD_ERROR_OF_MEAN|1.502||0.4483|TWO_SIDED|80.0|-3.08|0.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.79|-3.08|0.4483
91613892|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.585|||<|0.0001|TWO_SIDED|95.0|1.358|1.849|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.849|1.358|<0.0001
91710793|NCT00105989|183313990|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.028
91520020|NCT01939548|182914182|SUPERIORITY_OR_OTHER||LSM Difference|0.81|STANDARD_ERROR_OF_MEAN|0.809||0.3201|TWO_SIDED|80.0|-0.23|1.85||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.85|-0.23|0.3201
91520021|NCT01939548|182914182|SUPERIORITY_OR_OTHER||LSM Difference|0.85|STANDARD_ERROR_OF_MEAN|0.813||0.2961|TWO_SIDED|80.0|-0.19|1.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.90|-0.19|0.2961
91646151|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
91775326|NCT04913610|183431693|OTHER||||||=|0.279||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.279
91775327|NCT04913610|183431693|OTHER||||||=|0.385||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.385
91775328|NCT04913610|183431693|OTHER||||||=|0.755||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.755
91775329|NCT03186209|183431695|SUPERIORITY||Rate Ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.36||Multiplicity protected by hierarchy testing procedure. First in line hypothesis testing, requiring p-value \<0.05.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||0.36|0.19|<0.0001
91775330|NCT03186209|183431696|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.17|0.34||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.34|0.17|<0.0001
91775331|NCT03186209|183431697|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0126|TWO_SIDED|95.0|-0.45|-0.05||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.05|-0.45|0.0126
91775332|NCT03186209|183431698|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1835|TWO_SIDED|95.0|-0.42|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma rescue medication use, region, use of maintenance oral corticosteroids, visit, treatment\*visit||||0.08|-0.42|0.1835
91775333|NCT03186209|183431699|SUPERIORITY||Mean Difference (Final Values)|38.66|||<|0.0001|TWO_SIDED|95.0|24.24|53.07||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline morning PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||53.07|24.24|<0.0001
91775334|NCT03186209|183431700|SUPERIORITY||Mean Difference (Final Values)|35.85|||<|0.0001|TWO_SIDED|95.0|21.52|50.18||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline evening PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||50.18|21.52|<0.0001
91775335|NCT03186209|183431701|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.3385|TWO_SIDED|95.0|-0.03|0.01||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline proportion of nights awakening, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.01|-0.03|0.3385
91775336|NCT03186209|183431702|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.58|-0.28||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline ACQ-6 score, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.28|-0.58|<0.0001
91775337|NCT03186209|183431703|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.23|0.43||Nominal p-value. Not multiplicity protected by testing procedure.|Regression, Cox|model including covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.43|0.23|<0.0001
91775338|NCT03186209|183431704|SUPERIORITY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.42||Nominal p-value. Not multiplicity protected by testing procedure.|Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year (2, \>=3), use of OCS||||0.42|0.19|<0.0001
91775339|NCT03186209|183431705|SUPERIORITY||Mean Difference (Final Values)|-9.19|||<|0.0001|TWO_SIDED|95.0|-12.79|-5.6||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model with covariates: treatment group, baseline SGRQ total score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-5.60|-12.79|<0.0001
91775340|NCT03186209|183431706|SUPERIORITY||Rate ratio|0.46||||0.0222|TWO_SIDED|95.0|0.24|0.9||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model includes Treatment, use of maintenance oral corticosteroids, categorical variable of ER/UC or hospitalization exacerbations during previous year||||0.90|0.24|0.0222
91775341|NCT03186209|183431710|SUPERIORITY||Mean Difference (Final Values)|-119.31|||<|0.0001|TWO_SIDED|95.0|-169.78|-68.84||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|model includes treatment , baseline eosinophil count, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-68.84|-169.78|<0.0001
91775342|NCT03186209|183431711|SUPERIORITY||Rate Ratio|0.83||||0.4519|TWO_SIDED|95.0|0.51|1.35||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||1.35|0.51|0.4519
91775343|NCT03186209|183431712|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0214|TWO_SIDED|95.0|0.02|0.22||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.22|0.02|0.0214
91775344|NCT03186209|183431713|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1589|TWO_SIDED|95.0|-0.51|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.08|-0.51|0.1589
91775345|NCT00988832|183431787|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91775346|NCT00988832|183431788|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANOVA|||||||0.0004
91775347|NCT00988832|183431789|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||ANOVA|||||||0.0041
91775348|NCT00988832|183431790|SUPERIORITY_OR_OTHER|||||||0.0423||95.0|||||ANOVA|||||||0.0423
91775349|NCT00988832|183431791|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANOVA|||||||0.0006
91775350|NCT00988832|183431792|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||ANOVA|||||||0.0014
91520022|NCT01939548|182914182|SUPERIORITY_OR_OTHER||LSM Difference|0.39|STANDARD_ERROR_OF_MEAN|0.743||0.6015|TWO_SIDED|80.0|-0.57|1.35||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.35|-0.57|0.6015
91775351|NCT00988832|183431794|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91710794|NCT00105989|183313991|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.008
91775352|NCT01446159|183431798|SUPERIORITY||Hazard Ratio (HR)|0.991||||0.86|TWO_SIDED|95.0|0.689|1.429|||Log Rank|||||1.429|0.689|0.86
91775353|NCT03174184|183431818|EQUIVALENCE|Equivalence tests will be conducted to examine whether the EBA0-14CFU of Arm A is different from the EBA0-14CFU of Arm B. A similar comparison will be done comparing Arm C to Arm D, Arm A to Arm C, Arm D to Arm E, Arm D to Arm F, and Arm E to Arm F.|||||<|0.001|||||||Regression, Linear|||||||<0.001
91775354|NCT03980730|183431855|SUPERIORITY|||||||0.2057|||||||Mixed Models Analysis|||||||0.2057
91775355|NCT03125226|183431899|OTHER|Single group mean and standard deviation||||||||||||||||Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.|Single group mean and standard deviation|||
91775356|NCT03125226|183431904|OTHER|The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||||||||||||||||The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||
91775357|NCT02787564|183431905|OTHER||||||<|0.001||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||<0.001
91775358|NCT02787564|183431906|OTHER|||||||0.038||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.038
91775359|NCT02787564|183431907|OTHER|||||||0.026||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.026
91775360|NCT02787564|183431908|OTHER|||||||0.443||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.443
91775361|NCT02787564|183431909|OTHER|||||||0.006||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.006
91775362|NCT02787564|183431910|OTHER|||||||0.029||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.029
91775363|NCT03577275|183431920|OTHER|||||||||||||||||"The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.~Assay sensitivity was evaluated by concentration-QTc analysis of the effect on delta delta QTcF of moxifloxacin using a similar model as for the primary analysis."|The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.|||
91775364|NCT02958917|183431925|SUPERIORITY||Mean Difference (Final Values)|-0.76|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775365|NCT02958917|183431926|SUPERIORITY||Cox Proportional Hazard|0.264|||<|0.05|TWO_SIDED|95.0|||||Regression, Cox|||||||<0.05
91775366|NCT02958917|183431927|SUPERIORITY||Slope|2.03|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775367|NCT02958917|183431928|SUPERIORITY||Median Difference (Final Values)|-0.108|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775368|NCT02958917|183431929|SUPERIORITY||Risk Difference (RD)|0.364|||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
91775369|NCT02958917|183431930|SUPERIORITY||Risk Difference (RD)|0.128|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||||||<0.05
91775370|NCT02958917|183431931|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775371|NCT02958917|183431932|SUPERIORITY||Mean Difference (Final Values)|-6.72|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775372|NCT02958917|183431933|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775373|NCT02958917|183431934|SUPERIORITY||Mean Difference (Final Values)|-7.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91775374|NCT02958917|183431935|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91520023|NCT01939548|182914182|SUPERIORITY_OR_OTHER||LSM Difference|0.21|STANDARD_ERROR_OF_MEAN|0.761||0.7787|TWO_SIDED|80.0|-0.77|1.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.19|-0.77|0.7787
91520024|NCT01939548|182914182|SUPERIORITY_OR_OTHER||LSM Difference|1.63|STANDARD_ERROR_OF_MEAN|1.285||0.2068|TWO_SIDED|80.0|-0.02|3.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||3.29|-0.02|0.2068
91775375|NCT02318706|183431987|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.03||||0.8773|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||Week 14 change from baseline||0.30|-0.35|0.8773
91775376|NCT02318706|183431987|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.15||||0.3494|TWO_SIDED|95.0|-0.48|0.17|||Mixed Models Analysis|||Week 14 change from baseline||0.17|-0.48|0.3494
91775377|NCT02318706|183431987|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.5||||0.0027|TWO_SIDED|95.0|-0.82|-0.17|||Mixed Models Analysis|||Week 14 change from baseline||-0.17|-0.82|0.0027
91775378|NCT04328077|183431990|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|9.44||0.7755|TWO_SIDED|95.0|-16.1|21.5|||ANCOVA|||||21.5|-16.1|0.7755
91775379|NCT04328077|183431990|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|9.369||0.1798|TWO_SIDED|95.0|-31.3|5.9|||ANCOVA|||||5.9|-31.3|0.1798
91775380|NCT04328077|183431990|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.807||0.4229|TWO_SIDED|95.0|-27.4|11.6|||ANCOVA|||||11.6|-27.4|0.4229
91775381|NCT04739982|183432017|SUPERIORITY||Cohen's D|0.03|STANDARD_ERROR_OF_MEAN|1.36||0.41|TWO_SIDED|95.0|-0.21|0.27||An independent samples t-test was conducted to compare the change in baseline and follow-up scores of treatment and treatment as usual participants.|t-test, 1 sided|Degrees of freedom=274 Significance level=.05||||.27|-.21|.41
91775382|NCT04739982|183432018|SUPERIORITY||Cohen's D|0.153|STANDARD_ERROR_OF_MEAN|1.45||0.095|TWO_SIDED|95.0|-0.08|0.39|||t-test, 1 sided|||||.39|-.08|.095
91775383|NCT04739982|183432020|SUPERIORITY||Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.55||0.09|TWO_SIDED|95.0|-0.09|0.47|||t-test, 1 sided|||||.47|-.09|.09
91520025|NCT01939548|182914182|SUPERIORITY_OR_OTHER||LSM Difference|0.98|STANDARD_ERROR_OF_MEAN|1.326||0.4611|TWO_SIDED|80.0|-0.73|2.69||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.69|-0.73|0.4611
91775384|NCT00537394|183432025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.|Risk Difference (RD)|3.2|||||TWO_SIDED|95.0|-6.1|12.5|||||Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.|Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.||12.5|-6.1|
91775385|NCT01283139|183432040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.057|TWO_SIDED|90.0|1.03|2.71|||Regression, Logistic|||||2.71|1.03|0.057
91775386|NCT01283139|183432040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.094|TWO_SIDED|90.0|1.01|2.54|||Regression, Logistic|||||2.54|1.01|0.094
91775387|NCT01283139|183432040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.031|TWO_SIDED|90.0|1.16|2.94|||Regression, Logistic|||||2.94|1.16|0.031
91775388|NCT01283139|183432041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.042|TWO_SIDED|90.0|1.13|3.14|||Regression, Logistic|||||3.14|1.13|0.042
91775389|NCT01283139|183432041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.264|TWO_SIDED|90.0|0.85|2.35|||Regression, Logistic|||||2.35|0.85|0.264
91775390|NCT01283139|183432041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.038|TWO_SIDED|90.0|1.14|3.19|||Regression, Logistic|||||3.19|1.14|0.038
91775391|NCT01283139|183432042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.808|TWO_SIDED|90.0|0.37|3.81|||Regression, Logistic|||||3.81|0.37|0.808
91775392|NCT01283139|183432042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.598|TWO_SIDED|90.0|0.45|4.66|||Regression, Logistic|||||4.66|0.45|0.598
91775393|NCT01283139|183432042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.884|TWO_SIDED|90.0|0.27|3.02|||Regression, Logistic|||||3.02|0.27|0.884
91775394|NCT01283139|183432043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.044|TWO_SIDED|90.0|1.22|7.01|||Regression, Logistic|||||7.01|1.22|0.044
91775395|NCT01283139|183432043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.498|TWO_SIDED|90.0|0.62|3.19|||Regression, Logistic|||||3.19|0.62|0.498
91775396|NCT01283139|183432043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03||||0.049|TWO_SIDED|90.0|1.2|7.68|||Regression, Logistic|||||7.68|1.20|0.049
91775397|NCT01283139|183432044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.27|TWO_SIDED|90.0|0.85|2.25|||Regression, Logistic|||||2.25|0.85|0.270
91775398|NCT01283139|183432044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.077|TWO_SIDED|90.0|1.04|2.74|||Regression, Logistic|||||2.74|1.04|0.077
91775399|NCT01283139|183432044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.453|TWO_SIDED|90.0|0.76|2.05|||Regression, Logistic|||||2.05|0.76|0.453
91775400|NCT04267380|183432055|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
91775401|NCT04267380|183432056|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91775402|NCT04267380|183432057|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
91775403|NCT04267380|183432058|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
91775404|NCT04267380|183432059|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
91775405|NCT04267380|183432060|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
91775406|NCT04267380|183432061|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
91775407|NCT04267380|183432062|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
91775408|NCT04267380|183432064|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
91775409|NCT04267380|183432065|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
91775410|NCT04267380|183432066|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
91775411|NCT04267380|183432067|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||||||0.83
91775412|NCT04267380|183432068|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91775413|NCT04267380|183432069|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
91775414|NCT04267380|183432070|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
91775415|NCT04267380|183432071|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
91775416|NCT04267380|183432072|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
91775417|NCT04267380|183432073|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
91520026|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|0.96|STANDARD_ERROR_OF_MEAN|0.591||0.1083|TWO_SIDED|80.0|0.19|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|0.19|0.1083
91710795|NCT00105989|183313992|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.046
91775418|NCT04267380|183432074|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
91775419|NCT00395746|183432154|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.27|||<|0.0001||95.0|-1.51|1.02||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||1.02|-1.51|<0.0001
91775420|NCT00395746|183432154|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.0|||<|0.0001||95.0|-1.24|-0.75|||ANOVA|A significance level of a two-sided 5% was used for statistical hypothesis testing.||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||-0.75|-1.24|<0.0001
91775421|NCT00395746|183432155|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.33||||||95.0|-1.62|-1.04|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.04|-1.62|
91775422|NCT00395746|183432155|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.96||||||95.0|-1.25|-0.67|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.67|-1.25|
91775423|NCT00395746|183432156|SUPERIORITY_OR_OTHER||Least Squares Mean|-32.4|||<|0.0001||95.0|-40.5|-24.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-24.2|-40.5|<0.0001
91775424|NCT00395746|183432156|SUPERIORITY_OR_OTHER||Least Squares Mean|-26.4|||<|0.0001||95.0|-34.5|-18.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-18.2|-34.5|<0.0001
91775425|NCT00395746|183432157|SUPERIORITY_OR_OTHER||Least Squares Mean|-30.2||||||95.0|-39.6|-20.7|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-20.7|-39.6|
91775426|NCT00395746|183432157|SUPERIORITY_OR_OTHER||Least Squares Mean|-24.4||||||95.0|-33.8|-14.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-14.9|-33.8|
91791311|NCT00492063|183460305|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.||4|-2|
91775427|NCT00395746|183432158|SUPERIORITY_OR_OTHER||Least Squares Mean|-150.22|||<|0.0001||95.0|-186.32|-114.12||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-114.12|-186.32|<0.0001
91775428|NCT00395746|183432158|SUPERIORITY_OR_OTHER||Least Squares Mean|-111.15|||<|0.0001||95.0|-147.61|-74.68||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-74.68|-147.61|<0.0001
91775429|NCT00395746|183432159|SUPERIORITY_OR_OTHER||Least Squares Mean|-127.57||||||95.0|-166.91|-88.24|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-88.24|-166.91|
91775430|NCT00395746|183432159|SUPERIORITY_OR_OTHER||Least Squares Mean|-68.68||||||95.0|-108.91|-28.45|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-28.45|-108.91|
91775431|NCT00395746|183432160|SUPERIORITY_OR_OTHER||Least Squares Mean|-44.45|||<|0.0001||95.0|-55.02|-33.89||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-33.89|-55.02|<0.0001
91520027|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|0.611||0.0869|TWO_SIDED|80.0|0.27|1.84||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.84|0.27|0.0869
91775432|NCT00395746|183432160|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.3|||<|0.0001||95.0|-45.06|-23.54||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-23.54|-45.06|<0.0001
91775433|NCT00395746|183432161|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.49||||||95.0|-46.77|-22.22|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-22.22|-46.77|
91775434|NCT00395746|183432161|SUPERIORITY_OR_OTHER||Least Squares Mean|-46.34||||||95.0|-58.49|-34.18|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-34.18|-58.49|
91775435|NCT00395746|183432162|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.37||||0.0433||95.0|-22.4|-0.34||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-0.34|-22.40|0.0433
91520028|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.575||0.8601|TWO_SIDED|80.0|-0.84|0.64||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.64|-0.84|0.8601
91646152|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
91520029|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.593||0.3454|TWO_SIDED|80.0|-1.33|0.2||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.20|-1.33|0.3454
91775436|NCT00395746|183432162|SUPERIORITY_OR_OTHER||Least Squares Mean|6.67||||0.2359||95.0|-4.39|17.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||17.73|-4.39|0.2359
91775437|NCT00395746|183432163|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.3||||||95.0|-24.69|-1.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.90|-24.69|
91775438|NCT00395746|183432163|SUPERIORITY_OR_OTHER||Least Squares Mean|-7.11||||||95.0|-18.42|4.21|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||4.21|-18.42|
91775439|NCT00395746|183432164|SUPERIORITY_OR_OTHER||Least Squares Mean|0.75||||0.0071||95.0|0.21|1.3||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.30|0.21|0.0071
91775440|NCT00395746|183432164|SUPERIORITY_OR_OTHER||Least Squares Mean|1.18|||<|0.0001||95.0|0.63|1.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.73|0.63|<0.0001
91775441|NCT00395746|183432165|SUPERIORITY_OR_OTHER||Least Squares Mean|1.04||||||95.0|0.42|1.66|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||1.66|0.42|
91775442|NCT00395746|183432165|SUPERIORITY_OR_OTHER||Least Squares Mean|1.13||||||95.0|0.51|1.75|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed||1.75|0.51|
91775443|NCT00395746|183432166|SUPERIORITY_OR_OTHER||Rate ratio|1.59||||||95.0|0.86|2.96|||Negative binomial regression|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.96|0.86|
91775444|NCT00395746|183432166|SUPERIORITY_OR_OTHER||Rate ratio|1.18||||||95.0|0.56|2.47|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.47|0.56|
91775445|NCT00395746|183432166|SUPERIORITY_OR_OTHER||Rate ratio|1.8||||||95.0|0.92|3.54|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.54|0.92|
91775446|NCT00395746|183432166|SUPERIORITY_OR_OTHER||Rate ratio|1.62||||||95.0|0.85|3.07|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.07|0.85|
91775447|NCT00395746|183432166|SUPERIORITY_OR_OTHER||Rate ratio|1.48||||||95.0|0.69|3.17|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.17|0.69|
91520030|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|0.78|STANDARD_ERROR_OF_MEAN|0.789||0.3273|TWO_SIDED|80.0|-0.24|1.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.79|-0.24|0.3273
91646153|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
91775448|NCT00395746|183432166|SUPERIORITY_OR_OTHER||Rate ratio|1.45||||||95.0|0.72|2.91|||Negative binomial regression model|||The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.91|0.72|
91775449|NCT00795704|183432215|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
91775450|NCT00795704|183432217|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91775451|NCT01247324|183432223|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.536|||<|0.0001|TWO_SIDED|95.0|0.4|0.719|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.719|0.4|<0.0001
91775452|NCT01247324|183432224|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0139|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||Time to onset CDP at week 12||0.90|0.37|= 0.0139
91775453|NCT01247324|183432225|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.058|||<|0.0001||95.0|0.032|0.104|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.104|0.032|< 0.0001
91775454|NCT01247324|183432226|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.229|||<|0.0001||95.0|0.174|0.3|||Negative Binomial Model||Adjusted by baseline T2 lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.300|0.174|< 0.0001
91775455|NCT01247324|183432227|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.61|||=|0.0106|TWO_SIDED|95.0|1.11|2.33|||CMH Chi-Squared test (stratified)|CMH (Cochran-Mantel-Haenszel) Chi-Squared test Stratified by Geographical Region (US vs. Rest of World) and Baseline EDSS (\<4.0 vs. \>=4.0)||||2.33|1.11|= 0.0106
91775456|NCT01247324|183432228|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0278|TWO_SIDED|95.0|0.34|0.95|||Log Rank|||Time to onset CDP at week 24||0.95|0.34|= 0.0278
91775457|NCT01247324|183432229|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.428|||<|0.0001||95.0|0.328|0.557|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.557|0.328|< 0.0001
91775458|NCT01247324|183432230|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.039|STANDARD_ERROR_OF_MEAN|0.039|=|0.3261|TWO_SIDED|95.0|-0.039|0.116|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.116|-0.039|= 0.3261
91775459|NCT01247324|183432231|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.168|STANDARD_ERROR_OF_MEAN|0.058|=|0.0042|TWO_SIDED|95.0|0.053|0.283|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 22.8%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.283|0.053|= 0.0042
91775460|NCT01247324|183432232|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.693|STANDARD_ERROR_OF_MEAN|0.564|=|0.2193|TWO_SIDED|95.0|-0.414|1.8|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||1.800|-0.414|= 0.2193
91775461|NCT01247324|183432233|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.74|||<|0.0001|TWO_SIDED|95.0|1.39|2.17|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.17|1.39|< 0.0001
91775462|NCT03474588|183432262|SUPERIORITY|||||||0.3||||||Presented is the p value for the interaction between time and treatment.|Regression, Linear|Random Effects Regression Models (RERM), time was log transformed to account for expectation of greater change closer to baseline||||||0.30
91775463|NCT03474588|183432263|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.14|TWO_SIDED|95.0|-0.46|3.24||presented is the p value for the interaction of treatment and time in the model.|Regression, Linear|||Random Effects Regression Model (RERM), included in the model were treatment, time and the interaction of time and treatment.||3.24|-0.46|0.14
91613893|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.501||||0.0317|TWO_SIDED|95.0|1.036|2.174|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.174|1.036|0.0317
91775464|NCT03474588|183432264|SUPERIORITY|||||||0.097|||||||ANOVA|||||||0.097
91775465|NCT03474588|183432265|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
91775466|NCT01607957|183432266|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.81|||Stratified log-rank test|||||0.81|0.58|<0.0001
91775467|NCT01607957|183432267|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Stratified log-rank test|||||0.57|0.41|<0.0001
91775468|NCT03905096|183432278|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|92.63|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|85.34|100.53|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||100.53|85.34|
91775469|NCT03905096|183432279|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.64|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|93.21|104.39|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||104.39|93.21|
91775470|NCT03905096|183432280|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.48|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|90.74|106.88|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||106.88|90.74|
91775471|NCT03905096|183432281|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.15|STANDARD_DEVIATION|14.4|||TWO_SIDED|90.0|89.01|112.68|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||112.68|89.01|
91520031|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|0.69|STANDARD_ERROR_OF_MEAN|0.806||0.3963|TWO_SIDED|80.0|-0.35|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|-0.35|0.3963
91710796|NCT00105989|183313993|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.035
91775472|NCT03905096|183432282|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|94.77|STANDARD_DEVIATION|10.6|||TWO_SIDED|90.0|88.36|101.64|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||101.64|88.36|
91775473|NCT03905096|183432283|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.06|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|94.56|105.87|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||105.87|94.56|
91775474|NCT02016781|183432287|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|Wald test of difference in adjusted OS estimates.||The null hypothesis is that the rates of three-year OS are the same for both treatments. The results posted are from the interim analysis per protocol study design.||||0.0001
91775475|NCT02016781|183432287|SUPERIORITY|||||||0.3345||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between response to hypomethylating therapy and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of response to hypomethylating therapy (No Response to Hypomethylation vs. Any Response or Hematologic Improvement to Hypomethylation vs. No Prior Hypomethylation) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3345
91775476|NCT02016781|183432287|SUPERIORITY|||||||0.7328||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between patient age and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of patient age (\< vs. \>= 65) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.7328
91775477|NCT02016781|183432287|SUPERIORITY|||||||0.6261||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between disease duration and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.6261
91775478|NCT02016781|183432287|SUPERIORITY|||||||0.4134||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS score and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4134
91775479|NCT02016781|183432287|SUPERIORITY|||||||0.3147||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS-R score and treatment assignment in regression model.||Statistical Analysis 6: This subgroup analysis investigated the differential impact of IPSS-R score (Very Low, Low, or Intermediate vs. High vs. Very High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3147
91775480|NCT02016781|183432288|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments.||||0.0030
91775481|NCT02016781|183432288|SUPERIORITY|||||||0.9908||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of response to hypomethylating therapy on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.9908
91775482|NCT02016781|183432288|SUPERIORITY|||||||0.8981||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of patient age (\< or \>= 65) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.8981
91775483|NCT02016781|183432288|SUPERIORITY|||||||0.1465||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.1465
91710797|NCT00105989|183313994|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.011
91646154|NCT01236053|183184670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9253|TWO_SIDED|95.0|0.1|7.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.82|0.10|0.9253
91708088|NCT00482170|183309155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.24|<0.001
91775484|NCT02016781|183432288|SUPERIORITY|Statistical significance was determined using a pre-specified threshold of 0.05.||||||0.4991|||||||pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4991
91775485|NCT02016781|183432288|SUPERIORITY|||||||0.4953||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS-R score on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4953
91775486|NCT02016781|183432289|SUPERIORITY|||||||0.2777||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the FACT-G scores are the same at Enrollment for both treatments.||||0.2777
91775487|NCT02016781|183432289|SUPERIORITY|||||||0.225||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 6 Months for both treatments.||||0.2250
91775488|NCT02016781|183432289|SUPERIORITY|||||||0.1048||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 12 Months for both treatments.||||0.1048
91775489|NCT02016781|183432289|SUPERIORITY|||||||0.0888||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 18 Months for both treatments.||||0.0888
91775490|NCT02016781|183432289|SUPERIORITY|||||||0.5844||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 24 Months for both treatments.||||0.5844
91775491|NCT02016781|183432289|SUPERIORITY|||||||0.0344||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 36 Months for both treatments.||||0.0344
91775492|NCT02016781|183432290|SUPERIORITY|||||||0.5583||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 PCS scores are the same at Enrollment for both treatments.||||0.5583
91775493|NCT02016781|183432290|SUPERIORITY|||||||0.669||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 6 Months for both treatments.||||0.6690
91775494|NCT02016781|183432290|SUPERIORITY|||||||0.2089||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 12 Months for both treatments.||||0.2089
91775495|NCT02016781|183432290|SUPERIORITY|||||||0.4343||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 18 Months for both treatments.||||0.4343
91775496|NCT02016781|183432290|SUPERIORITY|||||||0.5942||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 24 Months for both treatments.||||0.5942
91775497|NCT02016781|183432290|SUPERIORITY|||||||0.1615||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 36 Months for both treatments.||||0.1615
91646155|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
91646156|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
91646157|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0||||0.0141|TWO_SIDED|95.0|1.43|25.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||25.11|1.43|0.0141
91520032|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|0.64|STANDARD_ERROR_OF_MEAN|0.888||0.4713|TWO_SIDED|80.0|-0.5|1.78||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.78|-0.50|0.4713
91775498|NCT02016781|183432290|SUPERIORITY|||||||0.5659||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 MCS scores are the same at Enrollment for both treatments.||||0.5659
91775499|NCT02016781|183432290|SUPERIORITY|||||||0.8555||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 6 Months for both treatments.||||0.8555
91520033|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|1.21|STANDARD_ERROR_OF_MEAN|0.895||0.1787|TWO_SIDED|80.0|0.06|2.36||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.36|0.06|0.1787
91710798|NCT00105989|183313995|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for fasting glucose change from baseline to endpoint|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.744
91775500|NCT02016781|183432290|SUPERIORITY|||||||0.8995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 12 Months for both treatments.||||0.8995
91775501|NCT02016781|183432290|SUPERIORITY|||||||0.0105||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 18 Months for both treatments.||||0.0105
91775502|NCT02016781|183432290|SUPERIORITY|||||||0.2596||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 24 Months for both treatments.||||0.2596
91775503|NCT02016781|183432290|SUPERIORITY|||||||0.5022||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 36 Months for both treatments.||||0.5022
91775504|NCT02016781|183432291|SUPERIORITY|||||||0.1768||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the EQ-5D scores are the same at Enrollment for both treatments.||||0.1768
91775505|NCT02016781|183432291|SUPERIORITY|||||||0.8318||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 6 Months for both treatments.||||0.8318
91775506|NCT02016781|183432291|SUPERIORITY|||||||0.4752||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 12 Months for both treatments.||||0.4752
91775507|NCT02016781|183432291|SUPERIORITY|||||||0.5671||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 18 Months for both treatments.||||0.5671
91775508|NCT02016781|183432291|SUPERIORITY|||||||0.3009||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 24 Months for both treatments.||||0.3009
91775509|NCT02016781|183432291|SUPERIORITY|||||||0.3403||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 36 Months for both treatments.||||0.3403
91775510|NCT02016781|183432292|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year OS are the same for both treatments in treated population.||||< 0.0001
91775511|NCT02016781|183432293|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments in treated population.||||< 0.0001
91775512|NCT04886154|183432315|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.67|||||TWO_SIDED|97.5|3.38|5.97|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,6-months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.97|3.38|
91775513|NCT04886154|183432315|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|-0.17|||||TWO_SIDED|97.5|-1.65|1.3|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||1.30|-1.65|
91775514|NCT04886154|183432315|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.6|||||TWO_SIDED|97.5|3.33|5.89|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,6- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.89|3.33|
91775515|NCT04886154|183432315|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|2.01|||||TWO_SIDED|97.5|0.6|3.42|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||3.42|0.60|
91775516|NCT04886154|183432316|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.03|||||TWO_SIDED|97.5|-4.21|10.17|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.17|-4.21|
91775517|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|4.66|||||TWO_SIDED|97.5|-2.71|11.64|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||11.64|-2.71|
91775518|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|5.48|||||TWO_SIDED|97.5|-0.71|12.25|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||12.25|-0.71|
91775519|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.87|||||TWO_SIDED|97.5|-3.7|10.97|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.97|-3.70|
91775520|NCT04886154|183432316|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|35.03|||||TWO_SIDED|97.5|25.22|44.75|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.75|25.22|
91613894|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.493||||0.0129|TWO_SIDED|95.0|1.089|2.048|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.048|1.089|0.0129
91775521|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|34.16|||||TWO_SIDED|97.5|23.76|44.1|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.10|23.76|
91520034|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.426||0.4123|TWO_SIDED|80.0|-0.2|0.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.90|-0.20|0.4123
91775522|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.88|||||TWO_SIDED|97.5|19.26|40.19|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||40.19|19.26|
91775523|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.54|||||TWO_SIDED|97.5|23.09|43.54|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||43.54|23.09|
91775524|NCT04886154|183432316|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|30.88|||||TWO_SIDED|97.5|21.61|40.32|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||40.32|21.61|
91775525|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the MenABCWY-2Gen MenACWY vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.35|||||TWO_SIDED|97.5|19.31|39.08|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||39.08|19.31|
91775526|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.02|||||TWO_SIDED|97.5|19.42|38.67|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||38.67|19.42|
91775527|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|25.13|||||TWO_SIDED|97.5|14.2|35.45|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||35.45|14.20|
91791312|NCT00492063|183460306|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||7|-3|
91613895|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.616||||0.0128|TWO_SIDED|95.0|1.107|2.357|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.357|1.107|0.0128
91520035|NCT01939548|182914183|SUPERIORITY_OR_OTHER||LSM Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.441||0.3202|TWO_SIDED|80.0|-1.01|0.13||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.13|-1.01|0.3202
91520036|NCT01939548|182914184|SUPERIORITY_OR_OTHER||LSM Difference|0.04|STANDARD_ERROR_OF_MEAN|0.119||0.7399|TWO_SIDED|80.0|-0.11|0.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.19|-0.11|0.7399
91613896|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.046||||0.7809|TWO_SIDED|95.0|0.763|1.432|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.432|0.763|0.7809
91775528|NCT04886154|183432316|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.38|||||TWO_SIDED|97.5|23.08|43.26|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||43.26|23.08|
91775529|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|28.18|||||TWO_SIDED|97.5|16.61|38.86|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.86|16.61|
91775530|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.37|||||TWO_SIDED|97.5|18.67|39.63|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||39.63|18.67|
91775531|NCT04886154|183432316|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|27.21|||||TWO_SIDED|97.5|15.46|38.02|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.02|15.46|
91775532|NCT03919773|183432352|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||Intention-to-treat analysis||||0.629
91775533|NCT03919773|183432353|SUPERIORITY|||||||0.718|||||||Fisher Exact|||comparison of proportion with positive treatment response (as defined) in IVIG group compared to albumin||||0.718
91775534|NCT04972162|183432377|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.38||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Ease of Communication Subscale (EC)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.38
91520037|NCT01939548|182914184|SUPERIORITY_OR_OTHER||LSM Difference|0.13|STANDARD_ERROR_OF_MEAN|0.122||0.2747|TWO_SIDED|80.0|-0.02|0.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.29|-0.02|0.2747
91520038|NCT01939548|182914185|SUPERIORITY_OR_OTHER||LSM Difference|0.07|STANDARD_ERROR_OF_MEAN|0.188||0.7219|TWO_SIDED|80.0|-0.17|0.31||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.31|-0.17|0.7219
91520039|NCT01939548|182914185|SUPERIORITY_OR_OTHER||LSM Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.192||0.9315|TWO_SIDED|80.0|-0.26|0.23||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.23|-0.26|0.9315
91520040|NCT01022762|182914205|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be shown if the upper limit of the 95% confidence interval was less than 0.4%. This corresponds to a one-sided test with a significance level of 2.5% of the hypothesis.|Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.066||||95.0|-0.115|0.143||The p-value corresponds to one-sided hypotheses of superiority with a significance level of 2.5%.|ANCOVA|ANCOVA model was with treatment, centre as explanatory variables and baseline HbA1c value as covariate.|If non-inferiority of repaglinide alone was shown, a test for superiority would be performed based on FAS. Superiority of repaglinide alone over gliclazide alone would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.|H0: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \>= 0.4%. H1: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \< 0.4%. Sample size was calculated to achieve a power of at least 85%, assuming an equal change in HbA1c and a common standard deviation of 1.2%.||0.143|-0.115|
91520041|NCT01302119|182914216|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91520042|NCT01302119|182914217|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91520043|NCT01302119|182914218|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91520044|NCT01302119|182914219|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91520045|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.||||0.0007
91520046|NCT00205348|182914260|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.||||<0.0001
91520047|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.||||0.0002
91520048|NCT00205348|182914260|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.||||<0.0001
91520049|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.0973|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.||||0.0973
91520050|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.1772|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.||||0.1772
91520051|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.||||0.0062
91520052|NCT00205348|182914260|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.||||<0.0001
91520053|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.||||0.0002
91520054|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.2125|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.||||0.2125
91520055|NCT00205348|182914260|SUPERIORITY_OR_OTHER|||||||0.0332|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.||||0.0332
91520056|NCT00450411|182914261|OTHER|||||||||||||||||It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming's multiple testing procedure with two interim analyses and one final analysis.|Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.|||
91646158|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.56||||0.0063|TWO_SIDED|95.0|1.83|40.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.02|1.83|0.0063
91775535|NCT04972162|183432377|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.79||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Background Noise Subscale (BN)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.79
91775536|NCT04972162|183432377|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.51||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Reverberant Room Subscale (RV)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.51
91775537|NCT04972162|183432377|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.44|||<|0.0001|TWO_SIDED|95.0|-4.3|5.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||5.2|-4.3|<0.0001
91775538|NCT04972162|183432377|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.97|||<|0.0001|TWO_SIDED|95.0|-5.3|7.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||7.2|-5.3|<0.0001
91775539|NCT04972162|183432377|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.98|||<|0.0001|TWO_SIDED|95.0|-4.6|6.5||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||6.5|-4.6|<0.0001
91791313|NCT00492063|183460306|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||4|-6|
91710799|NCT00105989|183313995|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for non-fasting glucose change from baseline to endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.030
91775540|NCT00385671|183432391|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.49||||0.076|TWO_SIDED|95.0|-0.05|1.04||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin \& duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||1.04|-0.05|0.076
91775541|NCT00385671|183432392|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.23||||0.417|TWO_SIDED|95.0|-0.32|0.78||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine \& duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||0.78|-0.32|0.417
91775542|NCT00385671|183432393|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
91775543|NCT00385671|183432393|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.520
91775544|NCT00385671|183432393|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
91775545|NCT00385671|183432394|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.389
91775546|NCT00385671|183432394|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.126
91775547|NCT00385671|183432394|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.489
91775548|NCT00385671|183432395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.602|TWO_SIDED|95.0|-0.2|0.35||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.35|-0.20|0.602
91646159|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
91520057|NCT05725317|182914269|NON_INFERIORITY|Noninferiority in distance visual acuity was declared if the upper confidence limit was less than 0.05.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction and sequence) and random (subject) effects. Difference = LID220365 minus LID006961. Sign is retained with the rounded value.|||0.00||
91520058|NCT00829387|182914270|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.39||||0.47|TWO_SIDED|95.0|-1.47|0.69|||Linear mixed model|||||0.69|-1.47|0.47
91520059|NCT00829387|182914271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.4|TWO_SIDED|95.0|-1.15|0.47|||linear mixed model|||baseline to 36 weeks post-baseline||0.47|-1.15|0.40
91520060|NCT00829387|182914272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.31|TWO_SIDED|95.0|-7.02|2.32|||Linear mixed model|||baseline to 12 weeks post-baseline||2.32|-7.02|0.31
91520061|NCT00829387|182914273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.03|1.06|||linear mixed model|||baseline to 12 weeks comparison||1.06|-1.03|0.98
91520062|NCT00829387|182914274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.03|TWO_SIDED|95.0|-1.76|-0.07|||linear mixed model|||baseline to 36 weeks post-baseline||-0.07|-1.76|0.03
91520063|NCT00829387|182914275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16||||0.15|TWO_SIDED|95.0|-9.86|1.55|||linear mixed model|||baseline to 36 weeks post-baseline||1.55|-9.86|0.15
91520064|NCT00707031|182914276|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was \<=0.4%.|Least squares (LS) mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|0.033|0.297||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), BMI (\<30, \>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate.||||To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.||0.297|0.033|
91520065|NCT02085252|182914285|SUPERIORITY_OR_OTHER|||||||0.0318||||||A 2-sided significance level of 5% was used. There was no adjustment for multiple comparisons.|Chi-squared|||The null hypothesis was that there was no difference between the two treatment strategies.||||0.0318
91520066|NCT05540522|182914336|OTHER||RVE|34.5|||||TWO_SIDED|95.0|7.4|53.9||||||||53.9|7.4|
91520067|NCT05540522|182914337|OTHER||RVE|-5.8|||||TWO_SIDED|95.0|-47.2|23.8||||||||23.8|-47.2|
91520068|NCT05540522|182914358|OTHER||GMR|1.23|||||TWO_SIDED|95.0|1.1|1.38||||||A/H3N2||1.38|1.10|
91775549|NCT00385671|183432395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.469|TWO_SIDED|95.0|-0.17|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.37|-0.17|0.469
91520069|NCT05540522|182914358|OTHER||GMR|1.24|||||TWO_SIDED|95.0|1.1|1.39||||||A/H1N1||1.39|1.10|
91520070|NCT05540522|182914358|OTHER||GMR|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||B/Yamagata||0.80|0.67|
91520071|NCT05540522|182914358|OTHER||GMR|0.3|||||TWO_SIDED|95.0|0.26|0.35||||||B/Victoria||0.35|0.26|
91520072|NCT05540522|182914359|OTHER||GMR|1.65|||||TWO_SIDED|95.0|1.47|1.84||||||A/H3N2||1.84|1.47|
91520073|NCT05540522|182914359|OTHER||GMR|1.71|||||TWO_SIDED|95.0|1.51|1.92||||||A/H1N1||1.92|1.51|
91520074|NCT05540522|182914359|OTHER||GMR|1.04|||||TWO_SIDED|95.0|0.95|1.14||||||B/Yamagata||1.14|0.95|
91520075|NCT05540522|182914359|OTHER||GMR|0.61|||||TWO_SIDED|95.0|0.54|0.69||||||B/Victoria||0.69|0.54|
91520076|NCT05540522|182914360|OTHER||Difference in percentage|11.4|||||TWO_SIDED|95.0|6.4|16.4||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||16.4|6.4|
91520077|NCT05540522|182914360|OTHER||Difference in percentage|13.6|||||TWO_SIDED|95.0|8.6|18.6||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||18.6|8.6|
91520078|NCT05540522|182914360|OTHER||Difference in percentage|-15.3|||||TWO_SIDED|95.0|-19.5|-11.2||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.2|-19.5|
91520079|NCT05540522|182914360|OTHER||Difference in percentage|-40.5|||||TWO_SIDED|95.0|-44.7|-36.1||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-36.1|-44.7|
91520080|NCT05540522|182914361|OTHER||Difference in percentage|21.6|||||TWO_SIDED|95.0|16.7|26.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||26.5|16.7|
91520081|NCT05540522|182914361|OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|20.9|30.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||30.4|20.9|
91520082|NCT05540522|182914361|OTHER||Difference in percentage|-2.1|||||TWO_SIDED|95.0|-4.8|0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||0.6|-4.8|
91520083|NCT05540522|182914361|OTHER||Difference in percentage|-22.6|||||TWO_SIDED|95.0|-26.7|-18.5||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-18.5|-26.7|
91520084|NCT05540522|182914362|OTHER||GMR|1.92|||||TWO_SIDED|95.0|1.78|2.07||||||A/H3N2||2.07|1.78|
91520085|NCT05540522|182914362|OTHER||GMR|1.68|||||TWO_SIDED|95.0|1.55|1.82||||||A/H1N1||1.82|1.55|
91520086|NCT05540522|182914362|OTHER||GMR|0.88|||||TWO_SIDED|95.0|0.82|0.94||||||B/Yamagata||0.94|0.82|
91520087|NCT05540522|182914362|OTHER||GMR|0.58|||||TWO_SIDED|95.0|0.53|0.63||||||B/Victoria||0.63|0.53|
91520088|NCT05540522|182914363|OTHER||GMR|2.38|||||TWO_SIDED|95.0|2.23|2.54||||||A/H3N2||2.54|2.23|
91520089|NCT05540522|182914363|OTHER||GMR|2.37|||||TWO_SIDED|95.0|2.22|2.54||||||A/H1N1||2.54|2.22|
91520090|NCT05540522|182914363|OTHER||GMR|1.36|||||TWO_SIDED|95.0|1.29|1.43||||||B/Yamagata||1.43|1.29|
91520091|NCT05540522|182914363|OTHER||GMR|0.76|||||TWO_SIDED|95.0|0.71|0.81||||||B/Victoria||0.81|0.71|
91520092|NCT05540522|182914364|OTHER||Difference in Percentage|26.8|||||TWO_SIDED|95.0|23.7|29.9||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.9|23.7|
91520093|NCT05540522|182914364|OTHER||Difference in Percentage|26.9|||||TWO_SIDED|95.0|23.9|29.8||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.8|23.9|
91520094|NCT05540522|182914364|OTHER||Difference in Percentage|-3.6|||||TWO_SIDED|95.0|-6.6|-0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-0.6|-6.6|
91520095|NCT05540522|182914364|OTHER||Difference in Percentage|-19.2|||||TWO_SIDED|95.0|-21.9|-16.6||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-16.6|-21.9|
91520096|NCT05540522|182914365|OTHER||Difference in Percentage|37.9|||||TWO_SIDED|95.0|35.2|40.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||40.5|35.2|
91520097|NCT05540522|182914365|OTHER||Difference in Percentage|44.9|||||TWO_SIDED|95.0|42.4|47.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||47.4|42.4|
91520098|NCT05540522|182914365|OTHER||Difference in Percentage|10.6|||||TWO_SIDED|95.0|8.5|12.8||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||12.8|8.5|
91520099|NCT05540522|182914365|OTHER||Difference in Percentage|-13.8|||||TWO_SIDED|95.0|-16.3|-11.3||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.3|-16.3|
91520100|NCT05520138|182914394|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|1.04|1.16|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.16|1.04|
91520101|NCT05520138|182914395|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.06|1.27|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.27|1.06|
91520102|NCT05520138|182914396|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.99|1.1|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.10|0.99|
91520103|NCT05520138|182914397|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|1.06|1.22|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.22|1.06|
91613897|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969|||<|0.0001|TWO_SIDED|95.0|0.962|0.976|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.976|0.962|<0.0001
91520104|NCT00789815|182914410|NON_INFERIORITY_OR_EQUIVALENCE|A preliminary study was performed to determine the sample size before this trial. 15 and 15 patients undergoing FB received BIS-guided propofol sedation and clinical-judged midazolam sedation, respectively. The incidences of hypoxemia were 0.33 and 0.20, respectively. The selected sample size of 225 in each group will yield 90% power for detecting a clinically meaningful difference of 0.13 at the 5.0% level of significance. To allow for 10% missing data, we recruited 250 patients per group.||||||0.05||95.0|||||Chi-squared|||"The null hypothesis: the incidence of hypoxemia occured during FB with BIS-guided propofol infusion is higher than that with clinical-judged midazolam administration.~Power calculation is described below."||||0.05
91520105|NCT00789815|182914411|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The null hypothesis: the incidence of hypotension during FB in patients of study group is higher than that in the control group.||||0.05
91520106|NCT00789815|182914412|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
91775550|NCT00385671|183432395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.841|TWO_SIDED|95.0|-0.24|0.3||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.30|-0.24|0.841
91775551|NCT00385671|183432396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.276|TWO_SIDED|95.0|-0.16|0.55||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.55|-0.16|0.276
91775552|NCT00385671|183432396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.929|TWO_SIDED|95.0|-0.33|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.||0.37|-0.33|0.929
91775553|NCT00385671|183432396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.313|TWO_SIDED|95.0|-0.53|0.17||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.17|-0.53|0.313
91775554|NCT00385671|183432397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.078|TWO_SIDED|95.0|-0.06|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.04|-0.06|0.078
91775555|NCT00385671|183432397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.025|TWO_SIDED|95.0|0.08|1.2||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.20|0.08|0.025
91775556|NCT00385671|183432397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||0.70|-0.41|0.602
91520107|NCT00789815|182914413|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
91520108|NCT00789815|182914414|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
91520109|NCT00789815|182914415|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the global tolerance of patients in study is worse than that in the control group.||||0.05
91520110|NCT00789815|182914416|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
91520111|NCT00789815|182914417|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
91520112|NCT02586025|182914419|SUPERIORITY||Difference in response rates|17.45||||0.0014|TWO_SIDED|95.0|6.89|28.01||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.01|6.89|0.0014
91520113|NCT02586025|182914420|SUPERIORITY||Difference in response rates|18.36||||0.0008|TWO_SIDED|95.0|7.89|28.83||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.83|7.89|0.0008
91520114|NCT02586025|182914421|SUPERIORITY||Difference in response rates|18.37||||0.001|TWO_SIDED|95.0|7.6|29.15||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.15|7.60|0.0010
91520115|NCT02586025|182914422|SUPERIORITY||Difference in response rates|18.83||||0.0006|TWO_SIDED|95.0|8.14|29.51||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.51|8.14|0.0006
91520116|NCT02586025|182914424|SUPERIORITY||Difference in response rates|10.4||||0.0125|TWO_SIDED|95.0|1.12|19.69||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||19.69|1.12|0.0125
91520117|NCT02586025|182914425|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.014|TWO_SIDED|95.0|0.32|0.89|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for EFS Event in the Pertuzumab arm vs. Placebo arm||0.89|0.32|0.0140
91520118|NCT02586025|182914425|SUPERIORITY||Difference in EFS Event-Free Rates|-8.16||||0.0062|TWO_SIDED|95.0|-14.0|-2.32|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 1 year||-2.32|-14.00|0.0062
91520119|NCT02586025|182914425|SUPERIORITY||Difference in EFS Event-Free Rates|-9.17||||0.0429|TWO_SIDED|95.0|-18.05|-0.29|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 3 years||-0.29|-18.05|0.0429
91520120|NCT02586025|182914425|SUPERIORITY||Difference in EFS Event-Free Rates|-11.1||||0.0274|TWO_SIDED|95.0|-20.95|-1.24|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 5 Years||-1.24|-20.95|0.0274
91520121|NCT02586025|182914426|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.014|TWO_SIDED|95.0|0.3|0.88|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for DFS Event in the Pertuzumab arm vs. Placebo arm||0.88|0.30|0.0140
91520122|NCT02586025|182914426|SUPERIORITY||Difference in DFS Event-Free Rates|-5.47||||0.0592|TWO_SIDED|95.0|-11.15|0.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 1 year||0.21|-11.15|0.0592
91520123|NCT02586025|182914426|SUPERIORITY||Difference in DFS Event-Free Rates|-9.0||||0.0426|TWO_SIDED|95.0|-17.69|-0.3|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 3 years||-0.30|-17.69|0.0426
91520124|NCT02586025|182914426|SUPERIORITY||Difference in DFS Event-Free Rates|-10.97||||0.0276|TWO_SIDED|95.0|-20.73|-1.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 5 years||-1.21|-20.73|0.0276
91520125|NCT02586025|182914427|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.1181|TWO_SIDED|95.0|0.23|1.19|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for OS Event in the Pertuzumab arm vs. Placebo arm||1.19|0.23|0.1181
91520126|NCT02586025|182914427|SUPERIORITY||Difference in OS Event-Free Rates|0.46||||0.3162|TWO_SIDED|95.0|-0.44|1.36|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 1 year||1.36|-0.44|0.3162
91520127|NCT02586025|182914427|SUPERIORITY||Difference in OS Event-Free Rates|-6.02||||0.0529|TWO_SIDED|95.0|-12.11|0.08|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 3 years||0.08|-12.11|0.0529
91520128|NCT02586025|182914427|SUPERIORITY||Difference in OS Event-Free Rates|-3.89||||0.2616|TWO_SIDED|95.0|-10.69|2.9|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 5 years||2.90|-10.69|0.2616
91520129|NCT02586025|182914433|OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.62|0.93|||||Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||0.93|-1.62|
91520130|NCT00415610|182914444|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.|repeated measure|Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score \> 8.||The hourly average (of maximum and minimum) SBP measurements were graphed with box-and-whiskers plot. In addition, a repeated measures analysis of the 25 average SBP (baseline and subsequent 24 hourly measures) was conducted with a mixed effects model (assuming autoregressive covariance structure in SAS version 9.1 PROC MIXED) to determine statistically the effect of treatment intensity (tier) on the average SBP over the 24 hrs with and without adjustment for baseline NIHSS score and age.||||< 0.01
91520131|NCT00415610|182914445|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED|||||Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.|Wilcoxon rank sum test|Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.||Done as a surrogate to evaluate the relationship between early SBP reduction and safety events.||||< .5
91520132|NCT02298361|182914480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.6|1.93|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||1.93|1.60|
91520133|NCT02298361|182914480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.91|2.72|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||2.72|1.91|
91520134|NCT02298361|182914481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.53|0.94|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||0.94|0.53|
91520135|NCT02298361|182914481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.45|0.67|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||0.67|0.45|
91520136|NCT01490502|182914514|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
91520137|NCT01490502|182914514|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.57|TWO_SIDED|95.0|0.67|2.05|||Regression, Cox|||||2.05|0.67|0.57
91520138|NCT01490502|182914515|OTHER|||||||0.07|||||||Andersen Gill model for recurrent events|||||||0.07
91520139|NCT01490502|182914516|SUPERIORITY||Rate Ratio|1.8||||0.07|TWO_SIDED|95.0|0.94|3.45|||Negative Binomial Model|||||3.45|0.94|0.07
91520140|NCT01490502|182914517|SUPERIORITY||Rate Ratio|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Negative Binomial Model|||||2.46|0.88|0.14
91520141|NCT01490502|182914518|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
91520142|NCT01490502|182914519|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||The average rate of change in MSFC Z-score over time was analyzed using a linear mixed-effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in the MSFC Z-score between treatment arms.||||0.20
91646160|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
91646161|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
91646162|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
91646163|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
91775557|NCT00385671|183432398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.353|TWO_SIDED|95.0|-0.34|0.94||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||0.94|-0.34|0.353
91646164|NCT01236053|183184671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9381||95.0|0.11|7.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.97|0.11|0.9381
91646165|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
91646166|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55||||0.0157|TWO_SIDED|95.0|1.78|260.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||260.2|1.78|0.0157
91646167|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
91646168|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.0333|TWO_SIDED|95.0|1.13|20.31|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||20.31|1.13|0.0333
91646169|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.2966|TWO_SIDED|95.0|0.35|32.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||32.06|0.35|0.2966
91646170|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.751|TWO_SIDED|95.0|0.03|12.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||12.31|0.03|0.7510
91646171|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.71||||0.1868|TWO_SIDED|95.0|0.4|113.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||113.4|0.40|0.1868
91646172|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.7558|TWO_SIDED|95.0|0.07|40.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.61|0.07|0.7558
91646173|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
91646174|NCT01236053|183184673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9244|TWO_SIDED|95.0|0.1|7.81|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.81|0.10|0.9244
91646175|NCT01236053|183184674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0963|TWO_SIDED|95.0|0.96|1.7|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.96|0.0963
91646176|NCT01236053|183184674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.671|TWO_SIDED|95.0|0.69|1.27|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.27|0.69|0.6710
91646177|NCT01236053|183184674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.54|2.2|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.20|1.54|<0.0001
91646178|NCT01236053|183184674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.24|1.81|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.81|1.24|<0.0001
91646179|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1184|TWO_SIDED|95.0|0.92|2.18|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.18|0.92|0.1184
91646180|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8016|TWO_SIDED|95.0|0.59|1.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.50|0.59|0.8016
91646181|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.91|1.77|<0.0001
91775558|NCT00385671|183432398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.039|TWO_SIDED|95.0|0.03|1.34||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||1.34|0.03|0.039
91775559|NCT00385671|183432398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.244|TWO_SIDED|95.0|-0.27|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.||1.04|-0.27|0.244
91775560|NCT00385671|183432399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.298|TWO_SIDED|95.0|-0.25|0.8||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.80|-0.25|0.298
91775561|NCT00385671|183432399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.304|TWO_SIDED|95.0|-0.25|0.81||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.81|-0.25|0.304
91775562|NCT00385671|183432399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.989|TWO_SIDED|95.0|-0.53|0.54||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.||0.54|-0.53|0.989
91775563|NCT00385671|183432400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.145|TWO_SIDED|95.0|-0.14|0.97||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||0.97|-0.14|0.145
91775564|NCT00385671|183432400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.112|TWO_SIDED|95.0|-0.11|1.03||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||1.03|-0.11|0.112
91775565|NCT00385671|183432400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.865|TWO_SIDED|95.0|-0.52|0.62||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||0.62|-0.52|0.865
91775566|NCT00385671|183432401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.263|TWO_SIDED|95.0|-0.26|0.95||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||0.95|-0.26|0.263
91775567|NCT00385671|183432401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.007|TWO_SIDED|95.0|0.24|1.49||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.49|0.24|0.007
91646182|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.51|2.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.58|1.51|<0.0001
91646183|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6105|TWO_SIDED|95.0|0.65|2.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.08|0.65|0.6105
91708089|NCT00482170|183309155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.22|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.22|<0.001
91520143|NCT01490502|182914520|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Rate of change in 2.5% low-contrast acuity was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in low-contrast acuity between treatment arms.||||0.67
91646184|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6797|TWO_SIDED|95.0|0.62|2.09|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.09|0.62|0.6797
91646185|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0103|TWO_SIDED|95.0|1.12|2.39|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.39|1.12|0.0103
91708090|NCT00482170|183309155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.26|0.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.56|0.26|<0.001
91708091|NCT00482170|183309155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.001|TWO_SIDED|95.0|0.28|0.58||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.58|0.28|<0.001
91708092|NCT00482170|183309156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.47|TWO_SIDED|95.0|0.6|1.26||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.26|0.60|0.470
91708093|NCT00482170|183309156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.325|TWO_SIDED|95.0|0.57|1.2||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.20|0.57|0.325
91708094|NCT00482170|183309156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.197|TWO_SIDED|95.0|0.55|1.13||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.13|0.55|0.197
91708095|NCT00482170|183309156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.212|TWO_SIDED|95.0|0.56|1.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.14|0.56|0.212
91708096|NCT00482170|183309157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|95.0|-0.91|0.46||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.||0.46|-0.91|0.515
91708097|NCT00482170|183309157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.34||0.842|TWO_SIDED|95.0|-0.74|0.6||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.60|-0.74|0.842
91708098|NCT00482170|183309157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.67|0.61||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.61|-0.67|0.928
91708099|NCT00482170|183309157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.32||0.974|TWO_SIDED|95.0|-0.62|0.64||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Last observation: ANOVA method was used for the analysis.||0.64|-0.62|0.974
91646186|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1629|TWO_SIDED|95.0|0.89|2.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.00|0.89|0.1629
91646187|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4713|TWO_SIDED|95.0|0.73|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.97|0.73|0.4713
91646188|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.4505|TWO_SIDED|95.0|0.49|1.38|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.49|0.4505
91646189|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.0284|TWO_SIDED|95.0|1.04|2.01|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.01|1.04|0.0284
91708100|NCT00482170|183309158|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.||||0.030
91520144|NCT01490502|182914521|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Rate of change in quality of life was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in health-related quality of life between treatment arms.||||0.21
91520145|NCT01490502|182914522|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
91520146|NCT01490502|182914523|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91775568|NCT00385671|183432401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.102|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.13|-0.10|0.102
91775569|NCT00385671|183432402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.922|TWO_SIDED|95.0|-0.61|0.55||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.55|-0.61|0.922
91775570|NCT00385671|183432402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.99||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.99|-0.20|0.195
91775571|NCT00385671|183432402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.162|TWO_SIDED|95.0|-0.17|1.02||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||1.02|-0.17|0.162
91775572|NCT00385671|183432403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.541|TWO_SIDED|95.0|-0.46|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||0.87|-0.46|0.541
91775573|NCT00385671|183432403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.051|TWO_SIDED|95.0|0.0|1.36||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.36|-0.00|0.051
91775574|NCT00385671|183432403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.173|TWO_SIDED|95.0|-0.21|1.15||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.15|-0.21|0.173
91775575|NCT00385671|183432404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.451|TWO_SIDED|95.0|-0.4|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.||0.90|-0.40|0.451
91775576|NCT00385671|183432404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.485|TWO_SIDED|95.0|-0.43|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.90|-0.43|0.485
91520147|NCT04186780|182914527|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters were normalized to logarithmic scale."|Mean Difference (Net)|2.5||||0.59|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group in total cholesterol.|||||0.59
91520148|NCT04186780|182914528|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|0.4||||0.8284|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group.|||||0.8284
91775577|NCT00385671|183432404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.68|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.65|-0.68|0.969
91520149|NCT04186780|182914529|SUPERIORITY||Median Difference (Net)|0.1||||0.0058|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group compared to the intervention group.|||||0.0058
91520150|NCT04186780|182914530|SUPERIORITY||Median Difference (Net)|0.8||||0.0384|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Reduced difference in TBARS in the placebo group compared to the intervention group at T66.|||||0.0384
91520151|NCT04186780|182914531|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|47.0||||0.0352|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between placebo group and intervention group of T66.|||||0.0352
91520152|NCT00152464|182914532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002|||=|0.991|TWO_SIDED|95.0|0.75|1.338|||Regression, Cox|||||1.338|0.750|=0.991
91520153|NCT02606903|182914576|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|110.19|STANDARD_DEVIATION|33.603|||TWO_SIDED|90.0|96.8|125.44|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and body mass index (BMI) group as fixed effects||125.44|96.80|
91520154|NCT02606903|182914577|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.14|STANDARD_DEVIATION|42.354|||TWO_SIDED|90.0|85.15|117.76|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||117.76|85.15|
91520155|NCT02606903|182914578|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.22|STANDARD_DEVIATION|53.137|||TWO_SIDED|90.0|82.13|122.29|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||122.29|82.13|
91520156|NCT00430248|182914589|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.|Difference in percentage|3.1||||||95.0|-1.9|8.1||||||The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.||8.1|-1.9|
91520157|NCT00430248|182914589|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||||0.233
91520158|NCT00430248|182914589|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||<|0.001||95.0|20.1|29.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||29.8|20.1|<0.001
91520159|NCT00430248|182914589|SUPERIORITY_OR_OTHER||Difference in percentage|21.9|||<|0.001||95.0|17.0|26.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||26.8|17.0|<0.001
91520160|NCT00430248|182914590|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.021
91520161|NCT00430248|182914590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520162|NCT00430248|182914590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520163|NCT00430248|182914591|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.031
91520164|NCT00430248|182914591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91646190|NCT01236053|183184675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6262|TWO_SIDED|95.0|0.77|1.54|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.54|0.77|0.6262
91646191|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0798|TWO_SIDED|95.0|0.95|2.41|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.95|0.0798
91646192|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8357|TWO_SIDED|95.0|0.64|1.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.73|0.64|0.8357
91520165|NCT00430248|182914591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520166|NCT00430248|182914592|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.578
91520167|NCT00430248|182914592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520168|NCT00430248|182914592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520169|NCT00430248|182914593|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.426
91520170|NCT00430248|182914593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520171|NCT00430248|182914593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520172|NCT00430248|182914594|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.050
91520173|NCT00430248|182914594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520174|NCT00430248|182914594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91646193|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.75|3.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.01|1.75|<0.0001
91775578|NCT00385671|183432405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.479|TWO_SIDED|95.0|-0.36|0.76||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.||0.76|-0.36|0.479
91646194|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.53|2.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.76|1.53|<0.0001
91775579|NCT00385671|183432405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.301|TWO_SIDED|95.0|-0.27|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.87|-0.27|0.301
91775580|NCT00385671|183432405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.47|0.67||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.67|-0.47|0.731
91775581|NCT00385671|183432406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.528|TWO_SIDED|95.0|-0.45|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.87|-0.45|0.528
91775582|NCT00385671|183432406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.626|TWO_SIDED|95.0|-0.84|0.51||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.51|-0.84|0.626
91775583|NCT00385671|183432406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.27|TWO_SIDED|95.0|-1.06|0.3||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.30|-1.06|0.270
91775584|NCT00385671|183432407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.098|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||1.13|-0.10|0.098
91775585|NCT00385671|183432407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.383|TWO_SIDED|95.0|-0.35|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.90|-0.35|0.383
91775586|NCT00385671|183432407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.452|TWO_SIDED|95.0|-0.86|0.39||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.39|-0.86|0.452
91775587|NCT00385671|183432408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.309|TWO_SIDED|95.0|-0.26|0.82||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.82|-0.26|0.309
91520175|NCT00430248|182914595|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.428
91520176|NCT00430248|182914595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520177|NCT00430248|182914595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520178|NCT00430248|182914596|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.041
91520179|NCT00430248|182914596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520180|NCT00430248|182914596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520181|NCT00430248|182914597|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.083
91520182|NCT00430248|182914597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520183|NCT00430248|182914597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520184|NCT00430248|182914598|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.421
91775588|NCT00385671|183432408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.174|TWO_SIDED|95.0|-0.17|0.93||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.93|-0.17|0.174
91775589|NCT00385671|183432408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.717|TWO_SIDED|95.0|-0.45|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.65|-0.45|0.717
91775590|NCT00385671|183432409|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.975
91775591|NCT00385671|183432409|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.448
91775592|NCT00385671|183432409|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.280
91775593|NCT00385671|183432410|SUPERIORITY_OR_OTHER|||||||0.548||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.548
91775594|NCT00385671|183432410|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.599
91775595|NCT00385671|183432410|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||1.00
91775596|NCT00385671|183432411|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.905
91775597|NCT00385671|183432411|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.368
91775598|NCT00385671|183432411|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.200
91708101|NCT00482170|183309158|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.||||0.010
91708102|NCT00482170|183309159|SUPERIORITY_OR_OTHER|||||||0.984||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.984
91708103|NCT00482170|183309159|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.549
91520185|NCT00430248|182914598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520186|NCT00430248|182914598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520187|NCT00430248|182914599|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.520
91520188|NCT00430248|182914599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520189|NCT00430248|182914599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520190|NCT00430248|182914600|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.195
91520191|NCT00430248|182914600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520192|NCT00430248|182914600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520193|NCT00430248|182914601|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.196
91520194|NCT00430248|182914601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520195|NCT00430248|182914601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
91520196|NCT00430248|182914602|SUPERIORITY_OR_OTHER|||||||0.079||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.079
91520197|NCT00430248|182914602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91708104|NCT00482170|183309160|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.158
91708105|NCT00482170|183309160|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.808
91708106|NCT00482170|183309161|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.||||0.029
91520198|NCT00430248|182914602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91520199|NCT00430248|182914603|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.685
91520200|NCT00430248|182914603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91520201|NCT00430248|182914603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91520202|NCT00430248|182914604|SUPERIORITY_OR_OTHER|||||||0.153||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.153
91520203|NCT00430248|182914604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91520204|NCT00430248|182914604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91708107|NCT00482170|183309161|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
91708108|NCT00482170|183309161|SUPERIORITY_OR_OTHER|||||||0.411||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.||||0.411
91708109|NCT00482170|183309161|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
91708110|NCT00482170|183309162|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.039
91708111|NCT00482170|183309162|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.006
91708112|NCT00482170|183309163|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.752
91708113|NCT00482170|183309163|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.700
91708114|NCT00482170|183309164|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.697
91708115|NCT00482170|183309164|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.159
91708116|NCT00482170|183309165|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.004
91708117|NCT00482170|183309165|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
91520205|NCT00430248|182914605|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.050
91520206|NCT00430248|182914605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91520207|NCT00430248|182914605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
91520208|NCT01624948|182914606|SUPERIORITY_OR_OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
91520209|NCT01624948|182914608|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Difference in p70S6 kinase phosphorylation as measured by mean fluorescence intensity (MFI) between those patients who reached the primary endpoint and those who did not||||0.67
91520210|NCT01624948|182914609|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91520211|NCT01624948|182914611|SUPERIORITY_OR_OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
91520212|NCT02219048|182914645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0719|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|90.0|-0.2243|0.0805|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 1||0.0805|-0.2243|
91520213|NCT02219048|182914645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.092|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.2362|0.0523|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 2||0.0523|-0.2362|
91708118|NCT00482170|183309166|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.652
91708119|NCT00482170|183309166|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
91775599|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.572
91775600|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.||||0.345
91775601|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.699
91775602|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.954
91775603|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.734
91775604|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.||||0.693
91775605|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.720
91775606|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.722
91775607|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.480
91775608|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.498
91775609|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.865||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.865
91775610|NCT00385671|183432412|SUPERIORITY_OR_OTHER|||||||0.408||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.408
91646195|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7794|TWO_SIDED|95.0|0.63|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.85|0.63|0.7794
91646196|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.8075|TWO_SIDED|95.0|0.52|1.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.66|0.52|0.8075
91708120|NCT00482170|183309167|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.560
91520214|NCT02219048|182914645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1131|STANDARD_ERROR_OF_MEAN|0.0837|||TWO_SIDED|90.0|-0.2536|0.0274|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 3||0.0274|-0.2536|
91520215|NCT02219048|182914645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.058|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|90.0|-0.1971|0.0812|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 4||0.0812|-0.1971|
91708121|NCT00482170|183309167|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.474
91708122|NCT00482170|183309168|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.023
91775611|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.635|TWO_SIDED|95.0|-2.18|1.33||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||1.33|-2.18|0.635
91775612|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.092|TWO_SIDED|95.0|-3.24|0.24||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.24|-3.24|0.092
91775613|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.221|TWO_SIDED|95.0|-2.8|0.65||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.65|-2.80|0.221
91775614|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.974|TWO_SIDED|95.0|-0.88|0.85||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.85|-0.88|0.974
91775615|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.093|TWO_SIDED|95.0|-1.63|0.13||P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.13|-1.63|0.093
91775616|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.091|TWO_SIDED|95.0|-1.59|0.12||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.12|-1.59|0.091
91775617|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.733|TWO_SIDED|95.0|-0.75|0.52||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.||0.52|-0.75|0.733
91775618|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.102|TWO_SIDED|95.0|-1.15|0.11||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.11|-1.15|0.102
91646197|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0001|TWO_SIDED|95.0|1.35|2.52|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.52|1.35|0.0001
91646198|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0161|TWO_SIDED|95.0|1.08|2.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.12|1.08|0.0161
91646199|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3972|TWO_SIDED|95.0|0.76|2.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.00|0.76|0.3972
91646200|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.495|TWO_SIDED|95.0|0.5|1.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.39|0.50|0.4950
91646201|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0601|TWO_SIDED|95.0|0.99|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.94|0.99|0.0601
91520216|NCT02219048|182914645|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.0837|STANDARD_ERROR_OF_MEAN|0.0742|||TWO_SIDED|90.0|-0.2081|0.0406|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Over Week 1 to 4||0.0406|-0.2081|
91708123|NCT00482170|183309168|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.089
91775619|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.193|TWO_SIDED|95.0|-1.04|0.21||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.21|-1.04|0.193
91775620|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.584|TWO_SIDED|95.0|-0.76|0.43||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.43|-0.76|0.584
91775621|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.077|TWO_SIDED|95.0|-1.12|0.06||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.06|-1.12|0.077
91775622|NCT00385671|183432413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.221|TWO_SIDED|95.0|-0.95|0.22||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.22|-0.95|0.221
91775623|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.096|TWO_SIDED|95.0|-3.96|0.32||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||0.32|-3.96|0.096
91775624|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.353|TWO_SIDED|95.0|-3.16|1.13||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.13|-3.16|0.353
91775625|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.444|TWO_SIDED|95.0|-1.27|2.88||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||2.88|-1.27|0.444
91775626|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.682|TWO_SIDED|95.0|-2.29|3.48||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||3.48|-2.29|0.682
91775627|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.45|TWO_SIDED|95.0|-4.08|1.82||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.82|-4.08|0.450
91775628|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.218|TWO_SIDED|95.0|-4.49|1.04||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.04|-4.49|0.218
91775629|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.747|TWO_SIDED|95.0|-0.36|0.26||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.26|-0.36|0.747
91520217|NCT02219048|182914648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.285|0.106|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Averaged Over Week 1 to 4||0.106|-0.285|
91708124|NCT00482170|183309169|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.494
91775630|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.18|0.45||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.45|-0.18|0.390
91775631|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.228|TWO_SIDED|95.0|-0.12|0.49||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.49|-0.12|0.228
91646202|NCT01236053|183184676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.9286|TWO_SIDED|95.0|0.71|1.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.45|0.71|0.9286
91646203|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.5394|TWO_SIDED|95.0|0.63|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.39|0.63|0.5394
91646204|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.507|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.58|0.39|0.5070
91775632|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.67|-0.18|0.260
91775633|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.141|TWO_SIDED|95.0|-0.76|0.11||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.11|-0.76|0.141
91775634|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.007|TWO_SIDED|95.0|-0.98|-0.16||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||-0.16|-0.98|0.007
91775635|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.409|TWO_SIDED|95.0|-0.61|0.25||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.25|-0.61|0.409
91775636|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.715|TWO_SIDED|95.0|-0.51|0.35||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.35|-0.51|0.715
91775637|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.641|TWO_SIDED|95.0|-0.32|0.52||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.32|0.641
91646205|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5426|TWO_SIDED|95.0|0.73|1.83|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.83|0.73|0.5426
91646206|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.515|TWO_SIDED|95.0|0.52|1.38|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.52|0.5150
91708125|NCT00482170|183309169|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.782
91775638|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.767|TWO_SIDED|95.0|-0.64|0.47||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.47|-0.64|0.767
91775639|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.881|TWO_SIDED|95.0|-0.61|0.52||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.61|0.881
91520218|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.017|STANDARD_ERROR_OF_MEAN|10.003|||TWO_SIDED|90.0|-10.76|22.794|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 1||22.794|-10.760|
91520219|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.591|STANDARD_ERROR_OF_MEAN|12.228|||TWO_SIDED|90.0|-13.926|27.108|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 2||27.108|-13.926|
91646207|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.435|TWO_SIDED|95.0|0.53|4.42|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||4.42|0.53|0.4350
91646208|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.8276|TWO_SIDED|95.0|0.37|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||3.43|0.37|0.8276
91646209|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.4022|TWO_SIDED|95.0|0.69|2.5|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.50|0.69|0.4022
91646210|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8681|TWO_SIDED|95.0|0.48|1.86|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.86|0.48|0.8681
91646211|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.6326|TWO_SIDED|95.0|0.2|13.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||13.86|0.20|0.6326
91646212|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.577|TWO_SIDED|95.0|0.21|16.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||16.86|0.21|0.5770
91708126|NCT00482170|183309170|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.444
91520220|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.954|STANDARD_ERROR_OF_MEAN|11.673|||TWO_SIDED|90.0|-18.644|20.552|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 3||20.552|-18.644|
91708127|NCT00482170|183309170|SUPERIORITY_OR_OTHER|||||||0.947||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.947
91646213|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8087|TWO_SIDED|95.0|0.4|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.21|0.40|0.8087
91646214|NCT01236053|183184677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8497|TWO_SIDED|95.0|0.31|2.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.64|0.31|0.8497
91646215|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.1528|TWO_SIDED|95.0|0.88|2.24|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.24|0.88|0.1528
91646216|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.9625|TWO_SIDED|95.0|0.62|1.65|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.65|0.62|0.9625
91646217|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.59|1.48|<0.0001
91646218|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0006|TWO_SIDED|95.0|1.25|2.29|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.29|1.25|0.0006
91646219|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.3515|TWO_SIDED|95.0|0.76|2.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.16|0.76|0.3515
91646220|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9069|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.82|0.59|0.9069
91646221|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.78|3.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.21|1.78|<0.0001
91520221|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.368|STANDARD_ERROR_OF_MEAN|12.92|||TWO_SIDED|90.0|-26.069|17.333|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 4||17.333|-26.069|
91520222|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.299|STANDARD_ERROR_OF_MEAN|10.503|||TWO_SIDED|90.0|-15.323|19.92|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB Averaged Over 4 Weeks||19.920|-15.323|
91775640|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.885|TWO_SIDED|95.0|-0.51|0.59||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.59|-0.51|0.885
91520223|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.135|STANDARD_ERROR_OF_MEAN|10.961|||TWO_SIDED|90.0|-17.248|19.519|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 1||19.519|-17.248|
91520224|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.834|STANDARD_ERROR_OF_MEAN|9.956|||TWO_SIDED|90.0|-13.871|19.54|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 2||19.540|-13.871|
91520225|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.374|STANDARD_ERROR_OF_MEAN|11.652|||TWO_SIDED|90.0|-27.933|11.185|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 3||11.185|-27.933|
91646222|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.48|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.81|1.48|<0.0001
91646223|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5948|TWO_SIDED|95.0|0.7|1.88|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.88|0.70|0.5948
91646224|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3984|TWO_SIDED|95.0|0.47|1.35|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.35|0.47|0.3984
91646225|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1872|TWO_SIDED|95.0|0.89|1.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.79|0.89|0.1872
91646226|NCT01236053|183184678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6772|TWO_SIDED|95.0|0.64|1.34|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.34|0.64|0.6772
91646227|NCT01236053|183184679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.4933|TWO_SIDED|95.0|0.07|3.72|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||3.72|0.07|0.4933
91646228|NCT01236053|183184679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.4147|TWO_SIDED|95.0|0.06|3.27|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||3.27|0.06|0.4147
91646229|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.8257|TWO_SIDED|95.0|0.15|10.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||10.38|0.15|0.8257
91646230|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.9467|TWO_SIDED|95.0|0.13|9.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||9.02|0.13|0.9467
91646231|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9859|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9859
91646232|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9857|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9857
91646233|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.986|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||0.00|0.00|0.9860
91646234|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9858|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9858
91646235|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9798|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9798
91646236|NCT01236053|183184680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9796|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9796
91646237|NCT01236053|183184681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.6252|TWO_SIDED|95.0|0.2|14.84|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||14.84|0.20|0.6252
91646238|NCT01236053|183184681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.7208|TWO_SIDED|95.0|0.17|13.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||13.28|0.17|0.7208
91646239|NCT01236053|183184683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.9141|TWO_SIDED|95.0|0.14|9.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||9.03|0.14|0.9141
91646240|NCT01236053|183184683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.9613|TWO_SIDED|95.0|0.12|7.78|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||7.78|0.12|0.9613
91646241|NCT01236053|183184684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0323|TWO_SIDED|95.0|1.02|1.57|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.57|1.02|0.0323
91646242|NCT01236053|183184684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0682|TWO_SIDED|95.0|0.99|1.52|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.99|0.0682
91646243|NCT01236053|183184684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0326|TWO_SIDED|95.0|1.01|1.4|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.40|1.01|0.0326
91646244|NCT01236053|183184684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0699|TWO_SIDED|95.0|0.99|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.36|0.99|0.0699
91520226|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|13.573|||TWO_SIDED|90.0|-23.245|22.356|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 4||22.356|-23.245|
91520227|NCT02219048|182914650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.212|STANDARD_ERROR_OF_MEAN|10.317|||TWO_SIDED|90.0|-18.52|16.096|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB Averaged Over 4 Weeks||16.096|-18.520|
91775641|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.325|TWO_SIDED|95.0|-0.96|0.32||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.32|-0.96|0.325
91775642|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.798|TWO_SIDED|95.0|-0.73|0.56||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.56|-0.73|0.798
91775643|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.461|TWO_SIDED|95.0|-0.39|0.87||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.87|-0.39|0.461
91775644|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.67|TWO_SIDED|95.0|-1.02|0.66||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.66|-1.02|0.670
91775645|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.243|TWO_SIDED|95.0|-1.37|0.35||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.35|-1.37|0.243
91775646|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.423|TWO_SIDED|95.0|-1.14|0.48||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.48|-1.14|0.423
91775647|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.333|TWO_SIDED|95.0|-1.04|0.35||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.35|-1.04|0.333
91775648|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.334|TWO_SIDED|95.0|-1.05|0.36||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.36|-1.05|0.334
91775649|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.69|0.68||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.68|-0.69|0.990
91520228|NCT00995501|182914656|SUPERIORITY||Odds Ratio (OR)|0.96||||0.86|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2|0.45|0.86
91775650|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.665|TWO_SIDED|95.0|-0.7|1.09||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||1.09|-0.70|0.665
91775651|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.1|0.74||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.74|-1.10|0.700
91520229|NCT00995501|182914656|SUPERIORITY||Odds Ratio (OR)|0.96||||0.87|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2|0.45|0.87
91520230|NCT00995501|182914656|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|99.6|0.49|2.2|||Regression, Logistic|||Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia||2.2|0.49|0.90
91775652|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.386|TWO_SIDED|95.0|-1.23|0.48||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.48|-1.23|0.386
91775653|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.12|TWO_SIDED|95.0|-1.27|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.27|0.120
91775654|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.119|TWO_SIDED|95.0|-1.29|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.29|0.119
91775655|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.71|0.69||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.69|-0.71|0.976
91775656|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.026|TWO_SIDED|95.0|0.14|2.2||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||2.20|0.14|0.026
91520231|NCT00995501|182914657|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8|TWO_SIDED|99.6|0.37|2.3|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2.3|0.37|0.8
91520232|NCT00995501|182914657|SUPERIORITY||Odds Ratio (OR)|1.1||||0.84|TWO_SIDED|99.6|0.43|2.7|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2.7|0.43|0.84
91775657|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.497|TWO_SIDED|95.0|-0.69|1.42||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||1.42|-0.69|0.497
91775658|NCT00385671|183432415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.112|TWO_SIDED|95.0|-1.8|0.19||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.19|-1.80|0.112
91775659|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.486
91775660|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.983
91775661|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.411
91775662|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.554
91775663|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.128
91775664|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.488
91520233|NCT00995501|182914657|SUPERIORITY||Odds Ratio (OR)|1.1||||0.87|TWO_SIDED|99.6|0.42|2.7|||Regression, Logistic|||||2.7|0.42|0.87
91775665|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.226
91775666|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.710
91775667|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.133
91775668|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.257
91775669|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.412||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.412
91775670|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.030
91775671|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.024
91775672|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.250
91775673|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.489
91775674|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.682
91775675|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.953
91775676|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.803||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.803
91646245|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.2893|TWO_SIDED|95.0|0.86|1.69|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.86|0.2893
91775677|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.694
91775678|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.835||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.835
91775679|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.435
91775680|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.379
91775681|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.247
91646246|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.4301|TWO_SIDED|95.0|0.82|1.61|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.61|0.82|0.4301
91775682|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.784
91775683|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.696
91775684|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.725
91775685|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.899
91775686|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.782
91775687|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.307
91775688|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.457
91775689|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.712
91775690|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.403
91775691|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.713
91775692|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.498
91646247|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0806|TWO_SIDED|95.0|0.97|1.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.58|0.97|0.0806
91646248|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.1226|TWO_SIDED|95.0|0.95|1.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.55|0.95|0.1226
91775693|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.963
91775694|NCT00385671|183432416|SUPERIORITY_OR_OTHER|||||||0.338||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.338
91775695|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.645
91775696|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.248
91775697|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.470
91775698|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.914
91775699|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.505
91775700|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.570
91775701|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.430
91775702|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.090
91646249|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3502|TWO_SIDED|95.0|0.8|1.89|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.89|0.80|0.3502
91520234|NCT01274182|182914658|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.106|||||TWO_SIDED|90.0|1.01|1.21|||||GP2013 arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.210|1.010|
91775703|NCT00385671|183432417|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.341
91775704|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.130
91775705|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.192
91775706|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.936
91775707|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.480
91775708|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.690
91775709|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.923
91775710|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.202
91775711|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.114
91775712|NCT00385671|183432418|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.954
91775713|NCT00385671|183432419|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.|Regression, Linear|||||||0.107
91775714|NCT00385671|183432420|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.968
91775715|NCT00385671|183432420|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.492
91775716|NCT00385671|183432420|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.463
91775717|NCT00385671|183432423|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.103
91775718|NCT00385671|183432423|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.167
91775719|NCT00385671|183432423|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.919
91775720|NCT00385671|183432426|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.008
91775721|NCT00385671|183432426|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.033
91775722|NCT00385671|183432426|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.688
91581645|NCT01190514|183053266|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|108.76|||||TWO_SIDED|90.0|101.1|117.01|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||117.01|101.10|
91708128|NCT00482170|183309171|SUPERIORITY_OR_OTHER|||||||0.787||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.787
91775723|NCT00385671|183432428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.365|TWO_SIDED|95.0|-0.33|0.9||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.90|-0.33|0.365
91708129|NCT00482170|183309171|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.379
91708130|NCT00482170|183309171|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.098
91708131|NCT00482170|183309171|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.166
91708132|NCT00482170|183309172|SUPERIORITY_OR_OTHER|||||||0.535||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.535
91708133|NCT00592592|183309182|OTHER||Cumulative incidence|10.9|||||TWO_SIDED|95.0|5.7|18.0||||||||18.0|5.7|
91708134|NCT00592592|183309184|OTHER||% hypothalamus normal tissue spared|88.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
91708135|NCT00592592|183309184|OTHER||% pituitary normal tissue spared|73.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
91708136|NCT00592592|183309184|OTHER||% lens (contra) normal tissue spared|100.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
91708137|NCT00592592|183309184|OTHER||% maxilla normal tissue spared|42.0||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
91708138|NCT00592592|183309185|OTHER||Percent Survival, Local Control|80.9|||||TWO_SIDED|95.0|73.0|87.7||||||||87.7|73.0|
91708139|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.055|||||TWO_SIDED|95.0|-0.067|0.178||||||Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2||0.178|-0.067|
91708140|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.024|||||TWO_SIDED|95.0|-0.102|0.151||||||Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3||0.151|-0.102|
91708141|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.08|||||TWO_SIDED|95.0|-0.204|0.045||||||Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1||0.045|-0.204|
91708142|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.174|||||TWO_SIDED|95.0|0.009|0.34||||||Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2||0.340|0.009|
91708143|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.12|||||TWO_SIDED|95.0|-0.297|0.056||||||Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3||0.056|-0.297|
91708144|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.054|||||TWO_SIDED|95.0|-0.225|0.117||||||Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1||0.117|-0.225|
91708145|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.058|||||TWO_SIDED|95.0|-0.068|0.184||||||Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2||0.184|-0.068|
91708146|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.042|||||TWO_SIDED|95.0|-0.167|0.082||||||Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3||0.082|-0.167|
91775724|NCT00385671|183432428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.172|TWO_SIDED|95.0|-0.2|1.13||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||1.13|-0.20|0.172
91775725|NCT00385671|183432428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.594|TWO_SIDED|95.0|-0.49|0.85||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.85|-0.49|0.594
91775726|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.622|TWO_SIDED|95.0|-0.48|0.8||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||0.80|-0.48|0.622
91775727|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.153|TWO_SIDED|95.0|-0.18|1.16||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.16|-0.18|0.153
91775728|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.344|TWO_SIDED|95.0|-0.35|1.0||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.00|-0.35|0.344
91775729|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.058|TWO_SIDED|95.0|-0.02|1.45||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.45|-0.02|0.058
91775730|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.032|TWO_SIDED|95.0|0.07|1.59||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.59|0.07|0.032
91775731|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.762|TWO_SIDED|95.0|-0.66|0.9||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||0.90|-0.66|0.762
91775732|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.029|TWO_SIDED|95.0|0.09|1.73||P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.73|0.09|0.029
91613898|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.298||||0.0189|TWO_SIDED|95.0|1.273|14.512|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.512|1.273|0.0189
91775733|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.01|TWO_SIDED|95.0|0.27|1.97||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.97|0.27|0.010
91775734|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.619|TWO_SIDED|95.0|-0.63|1.06||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.06|-0.63|0.619
91775735|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.058|TWO_SIDED|95.0|-0.03|1.69||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||1.69|-0.03|0.058
91775736|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.001|TWO_SIDED|95.0|0.61|2.41||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||2.41|0.61|0.001
91775737|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.142|TWO_SIDED|95.0|-0.23|1.58||P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.58|-0.23|0.142
91775738|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.065|TWO_SIDED|95.0|-0.05|1.76||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.76|-0.05|0.065
91775739|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|0.75|2.65||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||2.65|0.75|<0.001
91775740|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.079|TWO_SIDED|95.0|-0.1|1.79||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.79|-0.10|0.079
91775741|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.093|TWO_SIDED|95.0|-0.13|1.71||P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.71|-0.13|0.093
91775742|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56||||0.002|TWO_SIDED|95.0|0.59|2.53||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||2.53|0.59|0.002
91646250|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4654|TWO_SIDED|95.0|0.76|1.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.81|0.76|0.4654
91775743|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.119|TWO_SIDED|95.0|-0.2|1.74||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.74|-0.20|0.119
91775744|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.036|TWO_SIDED|95.0|0.06|1.91||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.91|0.06|0.036
91775745|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65|||<|0.001|TWO_SIDED|95.0|0.68|2.61||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.61|0.68|<0.001
91775746|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.178|TWO_SIDED|95.0|-0.3|1.63||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.63|-0.30|0.178
91775747|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.093|TWO_SIDED|95.0|-0.14|1.75||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.||1.75|-0.14|0.093
91775748|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.003|TWO_SIDED|95.0|0.53|2.51||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.51|0.53|0.003
91775749|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.157|TWO_SIDED|95.0|-0.28|1.71||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.71|-0.28|0.157
91775750|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.063|TWO_SIDED|95.0|-0.05|1.82||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.82|-0.05|0.063
91775751|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.7|2.66||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||2.66|0.70|<0.001
91791314|NCT00492063|183460306|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||8|0|
91646251|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.3987|TWO_SIDED|95.0|0.59|1.23|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.23|0.59|0.3987
91775752|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.114|TWO_SIDED|95.0|-0.19|1.77||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.77|-0.19|0.114
91775753|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.295|TWO_SIDED|95.0|-0.44|1.46||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.46|-0.44|0.295
91775754|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.005|TWO_SIDED|95.0|0.45|2.44||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||2.44|0.45|0.005
91775755|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.066|TWO_SIDED|95.0|-0.06|1.94||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.94|-0.06|0.066
91708147|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.016|||||TWO_SIDED|95.0|-0.144|0.113||||||Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1||0.113|-0.144|
91775756|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.208|TWO_SIDED|95.0|-0.35|1.58||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.58|-0.35|0.208
91775757|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.49|2.51||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||2.51|0.49|0.004
91775758|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.086|TWO_SIDED|95.0|-0.13|1.89||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.89|-0.13|0.086
91775759|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.328|TWO_SIDED|95.0|-0.49|1.45||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.45|-0.49|0.328
91775760|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.005|TWO_SIDED|95.0|0.44|2.47||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||2.47|0.44|0.005
91775761|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.059|TWO_SIDED|95.0|-0.04|1.99||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.99|-0.04|0.059
91775762|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.117|TWO_SIDED|95.0|-0.09|0.79||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.79|-0.09|0.117
91775763|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.412|TWO_SIDED|95.0|-0.25|0.62||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.62|-0.25|0.412
91775764|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.445|TWO_SIDED|95.0|-0.6|0.26||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.26|-0.60|0.445
91708148|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.144|||||TWO_SIDED|95.0|-0.006|0.295||||||Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2||0.295|-0.006|
91708149|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.06|||||TWO_SIDED|95.0|-0.207|0.088||||||Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3||0.088|-0.207|
91775765|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.025|TWO_SIDED|95.0|0.07|1.09||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||1.09|0.07|0.025
91775766|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.257|TWO_SIDED|95.0|-0.21|0.79||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.79|-0.21|0.257
91775767|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.21|-0.79|0.257
91775768|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.04||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||1.04|-0.05|0.075
91775769|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.634|TWO_SIDED|95.0|-0.42|0.68||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.68|-0.42|0.634
91775770|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.193|TWO_SIDED|95.0|-0.91|0.19||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.19|-0.91|0.193
91775771|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.688|TWO_SIDED|95.0|-0.46|0.7||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.70|-0.46|0.688
91775772|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.944|TWO_SIDED|95.0|-0.6|0.56||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.56|-0.60|0.944
91775773|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.64|TWO_SIDED|95.0|-0.73|0.45||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.45|-0.73|0.640
91581646|NCT01190514|183053268|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|95.1|||||TWO_SIDED|90.0|89.37|101.2|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||101.20|89.37|
91775774|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.439|TWO_SIDED|95.0|-0.37|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.37|0.439
91775775|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.461|TWO_SIDED|95.0|-0.38|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.38|0.461
91775776|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.62|0.6||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.60|-0.62|0.976
91775777|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.829|TWO_SIDED|95.0|-0.55|0.68||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.68|-0.55|0.829
91775778|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.713|TWO_SIDED|95.0|-0.5|0.74||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.74|-0.50|0.713
91775779|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.878|TWO_SIDED|95.0|-0.58|0.67||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.67|-0.58|0.878
91775780|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.447|TWO_SIDED|95.0|-0.38|0.85||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.85|-0.38|0.447
91775781|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.511|TWO_SIDED|95.0|-0.41|0.83||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.83|-0.41|0.511
91775782|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.924|TWO_SIDED|95.0|-0.65|0.59||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.59|-0.65|0.924
91775783|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.185|TWO_SIDED|95.0|-0.2|1.06||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||1.06|-0.20|0.185
91775784|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.403|TWO_SIDED|95.0|-0.37|0.91||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.91|-0.37|0.403
91775785|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.636|TWO_SIDED|95.0|-0.79|0.49||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.49|-0.79|0.636
91775786|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.304|TWO_SIDED|95.0|-0.3|0.95||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.95|-0.30|0.304
91775787|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.295|TWO_SIDED|95.0|-0.29|0.97||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.97|-0.29|0.295
91520235|NCT01274182|182914658|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.012|||||TWO_SIDED|90.0|0.925|1.108|||||GP2013 arm is the numerator and Rituxan arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.108|0.925|
91646252|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.3349|TWO_SIDED|95.0|0.58|1.2|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.20|0.58|0.3349
91775788|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.975|TWO_SIDED|95.0|-0.62|0.64||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.64|-0.62|0.975
91775789|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.349|TWO_SIDED|95.0|-0.33|0.93||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.93|-0.33|0.349
91775790|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.351|TWO_SIDED|95.0|-0.34|0.94||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.94|-0.34|0.351
91775791|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.64|0.65||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.65|-0.64|0.992
91775792|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.681|TWO_SIDED|95.0|-0.5|0.77||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.77|-0.50|0.681
91775793|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.569|TWO_SIDED|95.0|-0.46|0.83||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.83|-0.46|0.569
91775794|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.871|TWO_SIDED|95.0|-0.6|0.7||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.70|-0.60|0.871
91775795|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.675|TWO_SIDED|95.0|-0.5|0.78||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.78|-0.50|0.675
91775796|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.823|TWO_SIDED|95.0|-0.57|0.72||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.72|-0.57|0.823
91646253|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0827|TWO_SIDED|95.0|0.96|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.98|0.96|0.0827
91775797|NCT00385671|183432429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.85|TWO_SIDED|95.0|-0.72|0.59||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.59|-0.72|0.850
91775798|NCT00385671|183432431|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.448
91775799|NCT00385671|183432431|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.118
91775800|NCT00385671|183432431|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.021
91775801|NCT00385671|183432431|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.537
91775802|NCT00385671|183432431|SUPERIORITY_OR_OTHER|||||||0.911||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.911
91775803|NCT00385671|183432431|SUPERIORITY_OR_OTHER|||||||0.627||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.627
91775804|NCT00385671|183432432|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.078
91775805|NCT00385671|183432432|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.130
91775806|NCT00385671|183432432|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.850
91775807|NCT00385671|183432433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
91775808|NCT00385671|183432433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
91775809|NCT00385671|183432433|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||0.011
91775810|NCT00385671|183432434|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||0.830
91775811|NCT00385671|183432434|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
91775812|NCT00385671|183432434|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
91775813|NCT00385671|183432434|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.060
91775814|NCT00385671|183432434|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.502
91775815|NCT00385671|183432434|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.376
91775816|NCT00385671|183432435|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.281
91775817|NCT00385671|183432435|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.060
91775818|NCT00385671|183432435|SUPERIORITY_OR_OTHER|||||||0.596||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.596
91775819|NCT00385671|183432436|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.332
91775820|NCT00385671|183432436|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.||||0.065
91646254|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0932|TWO_SIDED|95.0|0.95|1.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.96|0.95|0.0932
91646255|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.013|TWO_SIDED|95.0|1.07|1.8|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.80|1.07|0.0130
91520236|NCT01274182|182914658|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.093|||||TWO_SIDED|90.0|0.989|1.208|||||Rituxan arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.208|0.989|
91646256|NCT01236053|183184685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.0241|TWO_SIDED|95.0|1.04|1.75|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.75|1.04|0.0241
91646257|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5043|TWO_SIDED|95.0|0.77|1.68|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.68|0.77|0.5043
91775821|NCT00385671|183432436|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.622
91775822|NCT00385671|183432436|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.103
91775823|NCT00385671|183432436|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.||||0.034
91775824|NCT00385671|183432436|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.808
91775825|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.055
91775826|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.||||0.051
91775827|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.993
91775828|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.928
91775829|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.||||0.609
91775830|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.675
91775831|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.985
91613899|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
91775832|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.||||0.847
91775833|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.832
91775834|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.169
91775835|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.||||0.910
91775836|NCT00385671|183432437|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.134
91775837|NCT00385671|183432438|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.||||0.285
91613900|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
91775838|NCT00385671|183432438|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.||||0.505
91775839|NCT00385671|183432438|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.||||0.679
91775840|NCT00385671|183432439|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.047
91775841|NCT00385671|183432439|SUPERIORITY_OR_OTHER|||||||0.232||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.232
91775842|NCT00385671|183432439|SUPERIORITY_OR_OTHER|||||||0.424||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.424
91775843|NCT00385671|183432440|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.298
91775844|NCT00385671|183432440|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.987
91775845|NCT00385671|183432440|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.297
91775846|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||1.00
91775847|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.749
91775848|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.750
91775849|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.050
91775850|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.320
91775851|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.440
91775852|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.498
91775853|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.245
91775854|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.160
91775855|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.280
91775856|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||1.00
91775857|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.023
91775858|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.264
91775859|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.325
91775860|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||1.00
91775861|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.121
91775862|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.095
91775863|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||1.00
91775864|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.720
91775865|NCT00385671|183432441|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.722
91775866|NCT01972217|183432454|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.017|TWO_SIDED|95.0|0.438|0.969|||Log Rank|||The 1-sided p-value provides a test for rejecting the null hypothesis of no treatment effect versus the superiority alternative that patients on olaparib have a lower risk of progression compared with placebo.||0.969|0.438|0.017
91775867|NCT01972217|183432467|OTHER||Odds Ratio (OR)|0.813||||0.309|TWO_SIDED|95.0|0.285|2.261||The p value was calculated with a 1-sided significance level of 2.5%.|Regression, Logistic|||||2.261|0.285|0.309
91520237|NCT01274182|182914659|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.076|||||TWO_SIDED|90.0|0.979|1.184|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.184|0.979|
91775868|NCT01972217|183432468|OTHER||Hazard Ratio (HR)|0.781||||0.095|TWO_SIDED|95.0|0.54|1.13||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olapatib + abiraterone versus placebo + abiraterone: TFST||1.130|0.540|0.095
91775869|NCT01972217|183432468|OTHER||Hazard Ratio (HR)|0.809||||0.147|TWO_SIDED|95.0|0.545|1.201||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olaparib + abiraterone versus placebo + abiraterone: TSST||1.201|0.545|0.147
91775870|NCT01972217|183432469|OTHER||Hazard Ratio (HR)|0.911||||0.331|TWO_SIDED|95.0|0.6|1.384||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.384|0.600|0.331
91775871|NCT01972217|183432470|OTHER||Hazard Ratio (HR)|0.788||||0.14|TWO_SIDED|95.0|0.511|1.215||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.215|0.511|0.140
91775872|NCT01456039|183432472|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)|Binomial test for dichotomized response|||||||<0.0001
91775873|NCT00313014|183432518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|95.0|-0.99|-0.35||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.35|-0.99|<.001
91775874|NCT00313014|183432518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.161|<|0.001|TWO_SIDED|95.0|-1.07|-0.44||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effect.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.44|-1.07|<.001
91775875|NCT00313014|183432519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.13||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.13|-0.90|.006
91775876|NCT00313014|183432519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.158|TWO_SIDED|95.0|-0.7|0.09||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.09|-0.70|.158
91775877|NCT00313014|183432520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.065|TWO_SIDED|95.0|-3.55|0.11||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.11|-3.55|.065
91775878|NCT00313014|183432520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.031||95.0|-3.79|-0.18||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.18|-3.79|.031
91775879|NCT00313014|183432521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|-9.64|-2.82||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed linear model: treatment, time as fixed effects, screening, prerandomization sleep disturbance subscale as covariates; subject as a random effect||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-2.82|-9.64|<.001
91775880|NCT00313014|183432521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.65|STANDARD_ERROR_OF_MEAN|1.709||0.121||95.0|-6.01|0.7||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that BTDS 20 arm was different from the BTDS 5 arm.||0.70|-6.01|.121
91775881|NCT03714672|183432522|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.4|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.4|-4.8|<0.0001
91775882|NCT03714672|183432522|SUPERIORITY||Mean Difference (Final Values)|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.2|-3.8|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.8|-5.2|<0.0001
91775883|NCT03714672|183432522|SUPERIORITY||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.5|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.5|-3.9|<0.0001
91775884|NCT03714672|183432522|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.1|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.1|-3.5|<0.0001
91646258|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7129|TWO_SIDED|95.0|0.73|1.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.59|0.73|0.7129
91646259|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.2055|TWO_SIDED|95.0|0.91|1.57|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.57|0.91|0.2055
91775885|NCT03081117|183432533|SUPERIORITY|||||||0.669|||||||Fisher Exact|||Analysis of Enrolled group.||||0.669
91775886|NCT03081117|183432534|SUPERIORITY||Mean Difference (Net)|-0.3914||||0.0366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 14||Analysis for Intent-to-Treat group.||||0.0366
91775887|NCT03081117|183432534|SUPERIORITY||Mean Difference (Net)|-0.5146||||0.0103|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 12||Analysis for Per Protocol group.||||0.0103
91775888|NCT03081117|183432537|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
91775889|NCT03081117|183432538|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
91775890|NCT03081117|183432539|SUPERIORITY||Unstandardized beta coefficient|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.244|TWO_SIDED||||||Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||0.244
91775891|NCT03081117|183432540|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
91775892|NCT03081117|183432541|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
91646260|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3005|TWO_SIDED|95.0|0.88|1.52|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.88|0.3005
91775893|NCT03081117|183432542|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
91775894|NCT03081117|183432543|SUPERIORITY||Mean Difference (Net)|0.0031351||||0.366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.366
91775895|NCT03081117|183432543|SUPERIORITY||Mean Difference (Net)|0.0025586||||0.505|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees fo freedom = 10||Analysis for Per Protocol group.||||0.505
91775896|NCT03081117|183432544|SUPERIORITY||Mean Difference (Net)|0.00000061||||0.98|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.98
91646261|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.2849|TWO_SIDED|95.0|0.84|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.77|0.84|0.2849
91775897|NCT03081117|183432544|SUPERIORITY||Mean Difference (Net)|-0.0000054||||0.86|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 10||Analysis for Per Protocol group.||||0.86
91775898|NCT02364700|183432550|EQUIVALENCE|Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.|||||<|0.05|||||||Friedman Test|||||||<.05
91775899|NCT01231984|183432564|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 8mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units.|Effect of 4mm versus 8mm PN on HbA1c|-0.076|||||TWO_SIDED|95.0|-0.209|0.058|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.058|-0.209|
91775900|NCT01231984|183432565|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4 mm PN and the longer PNs (pooled) was calculated. Equivalence limits for HbA1c were defined a-priori as +/- 0.4% units.|Effect of 4mm PN vs. longer PN on HbA1c|-0.09|||||TWO_SIDED|95.0|-0.23|0.051|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.051|-0.23|
91775901|NCT01231984|183432566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.36|||<|0.05|ONE_SIDED|95.0|0.37|||p\< 0.05 was considered statistically significant in this study|t-test, 1 sided|||"Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period."|||0.37|<0.05
91775902|NCT01231984|183432567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.83|||<|0.05|ONE_SIDED|95.0|18.54|||p\< 0.05 was considered statistically significant in this study.|t-test, 1 sided||||||18.54|<0.05
91775903|NCT01231984|183432569|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 12.7mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units|Effect of 4 mm vs.12.7mm PN on HbA1c|-0.095|||||TWO_SIDED|95.0|-0.19|0.0|||Two one-sided 95% confidence limit|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||-0.000|-0.190|
91775904|NCT03486912|183432607|SUPERIORITY||Odds Ratio (OR)|0.88||||0.773|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.773
91775905|NCT03486912|183432607|SUPERIORITY||Odds Ratio (OR)|0.72||||0.544|TWO_SIDED|95.0|0.23|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.23|0.544
91775906|NCT03486912|183432607|SUPERIORITY||Odds Ratio (OR)|0.88||||0.811|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.811
91775907|NCT03486912|183432608|SUPERIORITY||Odds Ratio (OR)|1.12||||0.836|TWO_SIDED|95.0|0.4|3.09|||Cochran-Mantel-Haenszel|||||3.09|0.40|0.836
91775908|NCT03486912|183432608|SUPERIORITY||Odds Ratio (OR)|0.86||||0.763|TWO_SIDED|95.0|0.3|2.46|||Cochran-Mantel-Haenszel|||||2.46|0.30|0.763
91775909|NCT03486912|183432608|SUPERIORITY||Odds Ratio (OR)|0.89||||0.821|TWO_SIDED|95.0|0.32|2.51|||Cochran-Mantel-Haenszel|||||2.51|0.32|0.821
91775910|NCT03486912|183432609|SUPERIORITY||Odds Ratio (OR)|1.13||||0.837|TWO_SIDED|95.0|0.39|3.25|||Cochran-Mantel-Haenszel|||||3.25|0.39|0.837
91775911|NCT03486912|183432609|SUPERIORITY||Odds Ratio (OR)|1.53||||0.359|TWO_SIDED|95.0|0.54|4.4|||Cochran-Mantel-Haenszel|||||4.40|0.54|0.359
91775912|NCT03486912|183432609|SUPERIORITY||Odds Ratio (OR)|1.26||||0.627|TWO_SIDED|95.0|0.44|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.44|0.627
91775913|NCT03486912|183432610|SUPERIORITY||Odds Ratio (OR)|1.12||||0.864|TWO_SIDED|95.0|0.4|3.16|||Cochran-Mantel-Haenszel|||||3.16|0.40|0.864
91775914|NCT03486912|183432610|SUPERIORITY||Odds Ratio (OR)|0.85||||0.743|TWO_SIDED|95.0|0.29|2.49|||Cochran-Mantel-Haenszel|||||2.49|0.29|0.743
91775915|NCT03486912|183432610|SUPERIORITY||Odds Ratio (OR)|0.79||||0.63|TWO_SIDED|95.0|0.27|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.27|0.630
91775916|NCT03486912|183432611|SUPERIORITY||Odds Ratio (OR)|1.43||||0.477|TWO_SIDED|95.0|0.48|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.48|0.477
91775917|NCT03486912|183432611|SUPERIORITY||Odds Ratio (OR)|1.04||||0.814|TWO_SIDED|95.0|0.32|3.44|||Cochran-Mantel-Haenszel|||||3.44|0.32|0.814
91775918|NCT03486912|183432611|SUPERIORITY||Odds Ratio (OR)|0.64||||0.367|TWO_SIDED|95.0|0.21|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.21|0.367
91775919|NCT03486912|183432612|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||||||0.309
91775920|NCT03486912|183432612|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|||||||0.146
91775921|NCT03486912|183432612|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|||||||0.317
91775922|NCT03486912|183432613|SUPERIORITY||Odds Ratio (OR)|6.91||||0.054|TWO_SIDED|95.0|0.76|325.97|||Cochran-Mantel-Haenszel|||||325.97|0.76|0.054
91775923|NCT03486912|183432613|SUPERIORITY||Odds Ratio (OR)|12.21||||0.004|TWO_SIDED|95.0|1.5|549.08|||Cochran-Mantel-Haenszel|||||549.08|1.50|0.004
91775924|NCT03486912|183432613|SUPERIORITY||Odds Ratio (OR)|5.59||||0.087|TWO_SIDED|95.0|0.57|271.11|||Cochran-Mantel-Haenszel|||||271.11|0.57|0.087
91775925|NCT02491684|183432614|SUPERIORITY_OR_OTHER||Ratio of proportions|1.29||||0.645|TWO_SIDED|95.0|0.43|3.85|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.85|0.43|0.645
91646262|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.365|TWO_SIDED|95.0|0.82|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.72|0.82|0.3650
91775926|NCT02491684|183432615|SUPERIORITY_OR_OTHER||Ratio of proportions|1.97||||0.411|TWO_SIDED|95.0|0.39|9.89|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 7|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||9.89|0.39|0.411
91775927|NCT02491684|183432615|SUPERIORITY_OR_OTHER||Ratio of proportions|1.25||||0.659|TWO_SIDED|95.0|0.46|3.41|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.41|0.46|0.659
91775928|NCT02491684|183432616|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 14|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
91775929|NCT02491684|183432616|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
91775930|NCT02491684|183432617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.634|TWO_SIDED|95.0|0.45|3.77|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first severe exacerbation within 30 days of treatment start.||3.77|0.45|0.634
91646263|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.7559|TWO_SIDED|95.0|0.78|1.4|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.40|0.78|0.7559
91520238|NCT01274182|182914659|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.131|||||TWO_SIDED|90.0|1.027|1.244|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.244|1.027|
91520239|NCT01274182|182914659|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.946|1.167|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.167|0.946|
91520240|NCT01274182|182914660|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|0.989|||||TWO_SIDED|95.0|0.974|1.004|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.004|0.974|
91775931|NCT02491684|183432618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.973|TWO_SIDED|95.0|0.07|16.78|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first moderate exacerbation within 30 days of treatment start.||16.78|0.07|0.973
91775932|NCT02491684|183432620|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.09||||0.495|TWO_SIDED|95.0|-0.17|0.35|||ANCOVA|Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo for change from baseline in total score at Visit 4.|Analysis of change from baseline in total score at Visit 4.||0.35|-0.17|0.495
91775933|NCT02491684|183432620|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.715|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 6.||0.38|-0.26|0.715
91775934|NCT02491684|183432620|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 8.||0.28|-0.42|0.687
91775935|NCT02491684|183432621|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.516|TWO_SIDED|95.0|-0.23|0.45|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-14.||0.45|-0.23|0.516
91775936|NCT02491684|183432621|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.417|TWO_SIDED|95.0|-0.16|0.37|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-7.||0.37|-0.16|0.417
91775937|NCT02491684|183432621|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.954|TWO_SIDED|95.0|-0.34|0.36|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 8-14.||0.36|-0.34|0.954
91775938|NCT02491684|183432621|SUPERIORITY_OR_OTHER||LS Mean difference|0.0||||0.985|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 15-30.||0.35|-0.35|0.985
91775939|NCT02491684|183432623|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07||||0.66|TWO_SIDED|95.0|-0.38|0.24|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 6.||0.24|-0.38|0.660
91775940|NCT02491684|183432623|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.624|TWO_SIDED|95.0|-0.48|0.29|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 8.||0.29|-0.48|0.624
91775941|NCT02491684|183432624|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.309|TWO_SIDED|95.0|-0.51|1.59|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||1.59|-0.51|0.309
91775942|NCT02491684|183432625|SUPERIORITY_OR_OTHER||LS Mean difference|16.98||||0.059|TWO_SIDED|95.0|-0.63|34.6|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||34.60|-0.63|0.059
91775943|NCT02491684|183432625|SUPERIORITY_OR_OTHER||LS Mean difference|19.35||||0.01|TWO_SIDED|95.0|4.66|34.05|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||34.05|4.66|0.010
91775944|NCT02491684|183432625|SUPERIORITY_OR_OTHER||LS Mean difference|14.38||||0.153|TWO_SIDED|95.0|-5.44|34.2|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||34.20|-5.44|0.153
91775945|NCT02491684|183432625|SUPERIORITY_OR_OTHER||LS Mean difference|19.26||||0.096|TWO_SIDED|95.0|-3.44|41.97|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.97|-3.44|0.096
91520241|NCT01274182|182914660|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.021|||||TWO_SIDED|95.0|1.003|1.04|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.040|1.003|
91646264|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.852|TWO_SIDED|95.0|0.77|1.37|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.37|0.77|0.8520
91775946|NCT02491684|183432626|SUPERIORITY_OR_OTHER||LS Mean difference|0.07||||0.161|TWO_SIDED|95.0|-0.03|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.17|-0.03|0.161
91646265|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0459|TWO_SIDED|95.0|1.01|2.06|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.06|1.01|0.0459
91775947|NCT02491684|183432626|SUPERIORITY_OR_OTHER||LS Mean difference|0.08||||0.087|TWO_SIDED|95.0|-0.01|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.17|-0.01|0.087
91775948|NCT02491684|183432626|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.28|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.280
91775949|NCT02491684|183432626|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.086|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.24|-0.02|0.086
91775950|NCT02491684|183432627|SUPERIORITY_OR_OTHER||LS Mean difference|11.69||||0.211|TWO_SIDED|95.0|-6.76|30.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||30.14|-6.76|0.211
91775951|NCT02491684|183432627|SUPERIORITY_OR_OTHER||LS Mean difference|11.19||||0.125|TWO_SIDED|95.0|-3.18|25.56|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||25.56|-3.18|0.125
91775952|NCT02491684|183432627|SUPERIORITY_OR_OTHER||LS Mean difference|11.14||||0.277|TWO_SIDED|95.0|-9.08|31.36|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||31.36|-9.08|0.277
91775953|NCT02491684|183432627|SUPERIORITY_OR_OTHER||LS Mean difference|17.13||||0.161|TWO_SIDED|95.0|-6.92|41.18|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.18|-6.92|0.161
91775954|NCT02491684|183432628|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.287|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.16|-0.05|0.287
91775955|NCT02491684|183432628|SUPERIORITY_OR_OTHER||LS Mean difference|0.04||||0.457|TWO_SIDED|95.0|-0.06|0.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.14|-0.06|0.457
91775956|NCT02491684|183432628|SUPERIORITY_OR_OTHER||LS Mean difference|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.315
91775957|NCT02491684|183432628|SUPERIORITY_OR_OTHER||LS Mean difference|0.09||||0.134|TWO_SIDED|95.0|-0.03|0.22|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.22|-0.03|0.134
91775958|NCT00468169|183432655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1225||||||Log-rank test comparing PFS between two treatment arms|Log Rank|||||||0.1225
91775959|NCT03668873|183432670|SUPERIORITY||Difference of Least Squares Means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.88|-0.81||Threshold for significance was p=0.05.|Mixed Models Analysis|Mixed models with repeated measures with fixed effects for baseline CSI, treatment, week as a categorical variable, and treatment-week interaction.|Treatment difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on change in CSI score at 10 weeks. Assuming a standard deviation of 2.5 units and an attrition rate of 10%, an enrollment target of 90 participants would provide 90% power to detect a difference of 1.85 points or greater with a type I error rate of 0.05 using a two-tailed two-sample t-test.||-0.81|-2.88|<0.001
91775960|NCT03668873|183432671|SUPERIORITY||Absolute percent difference|24.0||||0.037|TWO_SIDED|95.0|2.0|46.0||Threshold for significance was 0.05|Chi-squared||Difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on the rate of positive response to CGI-I at 10 weeks. Assuming a 25%-40% positive response rate at 10 weeks in the SPE group and 45 patients per group, power was 90% to detect a 32% or greater difference in positive response rate (57%-72% in SPT group, respectively), with a type I error rate of 0.05 using a Chi-square test.||46|2|0.037
91775961|NCT03668873|183432672|SUPERIORITY|||||||0.81||||||threshold for significant 0.05|Mixed Models Analysis|||||||0.81
91775962|NCT03668873|183432673|SUPERIORITY|||||||0.77||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.77
91775963|NCT03668873|183432674|SUPERIORITY|||||||0.003||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.003
91775964|NCT02183675|183432676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|108.39|STANDARD_ERROR_OF_MEAN|1.094|||TWO_SIDED|90.0|93.081|126.225|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||126.225|93.081|
91775965|NCT02183675|183432676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|114.86|STANDARD_ERROR_OF_MEAN|1.097|||TWO_SIDED|90.0|98.216|134.326|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||134.326|98.216|
91775966|NCT02183675|183432677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|97.53|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|90.43|105.19|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||105.19|90.43|
91520242|NCT01274182|182914660|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.033|||||TWO_SIDED|95.0|1.016|1.05|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.050|1.016|
91646266|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0542|TWO_SIDED|95.0|0.99|2.04|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.04|0.99|0.0542
91646267|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.0312|TWO_SIDED|95.0|1.03|1.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.74|1.03|0.0312
91520243|NCT01274182|182914661|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6.~LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.397|0.24|||||The direction of comparison is LS mean of GP2013 - LS mean of Rituxan|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.240|-0.397|
91520244|NCT01274182|182914661|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6. LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|95.0|-0.328|0.462|||||The direction of comparison is LS mean of GP2013 Part I - LS mean of MabThera|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.462|-0.328|
91520245|NCT01274182|182914662|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|9.77|STANDARD_ERROR_OF_MEAN|6.79|||TWO_SIDED|95.0|-3.54|23.08|||||The direction of comparison is response rate of GP2013 - response rate of Rituxan|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||23.08|-3.54|
91646268|NCT01236053|183184686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.0508|TWO_SIDED|95.0|1.0|1.7|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.70|1.00|0.0508
91646269|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0892|TWO_SIDED|95.0|0.94|2.42|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.42|0.94|0.0892
91646270|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1043|TWO_SIDED|95.0|0.92|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.39|0.92|0.1043
91775967|NCT02183675|183432677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|96.94|107.4|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||107.40|96.94|
91775968|NCT02183675|183432678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|104.8|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|101.949|107.734|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||107.734|101.949|
91775969|NCT02183675|183432679|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.95|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|90.0|101.023|106.964|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||106.964|101.023|
91775970|NCT02183675|183432680|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.49|STANDARD_ERROR_OF_MEAN|1.014|||TWO_SIDED|90.0|100.167|104.867|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||104.867|100.167|
91775971|NCT02183675|183432681|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|105.35|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|99.23|111.847|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||111.847|99.230|
91775972|NCT02183675|183432682|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.39|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|98.73|108.28|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||108.280|98.730|
91775973|NCT00784563|183432689|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.|Regression, Linear|||Sample size was estimated using 80% power to detect an effect size of 0.66 SD in VO2max (estimated improvement=10% /estimated SD of change=15%) within each arm at alpha=0.05 and an attrition rate of 25%.||||<0.001
91775974|NCT00784563|183432690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
91775975|NCT00784563|183432691|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Regression, Linear|||||||0.029
91775976|NCT00784563|183432692|SUPERIORITY_OR_OTHER|||||||0.271|TWO_SIDED||||||Regression, Linear|||||||0.271
91775977|NCT00784563|183432693|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||unadjusted p-value=0.009|Regression, Linear|||||||0.070
91775978|NCT00784563|183432694|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
91775979|NCT00784563|183432695|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Regression, Linear|||||||0.006
91775980|NCT00784563|183432696|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
91775981|NCT00784563|183432697|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Regression, Linear|Adjusted for change in total daily equivalent levodopa dose||||||0.003
91775982|NCT00784563|183432698|SUPERIORITY_OR_OTHER||||||=|0.146|TWO_SIDED||||||t-test, 2 sided|||||||=0.146
91775983|NCT00784563|183432699|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||0.037
91775984|NCT00784563|183432700|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.057
91775985|NCT01377584|183432770|OTHER||Effect size|-0.51|||||TWO_SIDED|||||||||||||
91775986|NCT01377584|183432770|OTHER||Effect size|-0.42|||||TWO_SIDED|||||||||||||
91775987|NCT01377584|183432770|OTHER||Effect size|-0.82|||||TWO_SIDED|||||||||||||
91775988|NCT01377584|183432770|OTHER||Effect size|-1.31|||||TWO_SIDED|||||||||||||
91775989|NCT01377584|183432770|OTHER||Effect size|-0.08|||||TWO_SIDED|||||||||||||
91775990|NCT01377584|183432770|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
91775991|NCT01377584|183432771|OTHER||Effect size|0.51|||||TWO_SIDED|||||||||||||
91775992|NCT01377584|183432771|OTHER||Effect size|0.41|||||TWO_SIDED|||||||||||||
91775993|NCT01377584|183432771|OTHER||Effect size|0.57|||||TWO_SIDED|||||||||||||
91775994|NCT01377584|183432771|OTHER||Effect size|1.54|||||TWO_SIDED|||||||||||||
91775995|NCT01377584|183432771|OTHER||Effect size|0.0|||||TWO_SIDED|||||||||||||
91775996|NCT01377584|183432771|OTHER||Effect size|0.65|||||TWO_SIDED|||||||||||||
91775997|NCT01377584|183432772|OTHER||Effect size|-1.01|||||TWO_SIDED|||||||||||||
91775998|NCT01377584|183432772|OTHER||Effect size|-0.94|||||TWO_SIDED|||||||||||||
91775999|NCT01377584|183432772|OTHER||Effect size|-0.4|||||TWO_SIDED|||||||||||||
91776000|NCT01377584|183432772|OTHER||Effect size|-0.31|||||TWO_SIDED|||||||||||||
91776001|NCT01377584|183432772|OTHER||Effect size|-0.65|||||TWO_SIDED|||||||||||||
91776002|NCT01377584|183432772|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
91776003|NCT01377584|183432773|OTHER||Effect size|0.52|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
91776004|NCT01377584|183432773|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month and 3 months|||||
91776005|NCT01377584|183432773|OTHER||Effect size|0.5|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
91776006|NCT01377584|183432773|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
91776007|NCT01377584|183432773|OTHER||Effect size|-0.92|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
91776008|NCT01377584|183432773|OTHER||Effect size|-0.26|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
91776009|NCT01576341|183432777|OTHER||Incidence rate|0.019|||||TWO_SIDED||||||||Incidence rate is based on duration of treatment period (years)|||||
91776010|NCT00310765|183432792|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measure analysis of variance modeling was used to evaluate whether the two study groups differed regarding the pain score change that occurred across each of the two study phases (weeks 0-7 and weeks 7-10). To conform to the analysis of variance assumption of distributional normality, the pain scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on exact rates from reference articles cited in the paper. Patients were randomly assigned to active drug (pregabalin) or look alike placebo.||4.0|0.0|<0.05
91776011|NCT00310765|183432793|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measures analysis of variance modeling was used to evaluate whether the two study groups differed regarding the sleep score change that occurred during the two study phases (weeks 0-7 and weeks 7-11. to conform to the analysis of variance assumption of distributional normality the sleep scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on the exact rates from the reference articles cited in the paper.||4.0|0.0|<0.05
91776012|NCT03413891|183432812|SUPERIORITY||Risk Ratio (RR)|0.93|||=|0.72|TWO_SIDED|95.0|0.6|1.42|||Chi-squared|||||1.42|0.60|=0.72
91520246|NCT01274182|182914662|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|-0.57|STANDARD_ERROR_OF_MEAN|7.23|||TWO_SIDED|95.0|-14.74|13.6|||||The direction of comparison is response rate of GP2013 Part I - response rate of MabThera|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||13.60|-14.74|
91581647|NCT01190514|183053268|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|101.3|||||TWO_SIDED|90.0|94.66|108.4|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||108.40|94.66|
91646271|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0101|TWO_SIDED|95.0|1.1|2.06|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||2.06|1.10|0.0101
91776013|NCT03413891|183432814|SUPERIORITY||Rate Ratio|0.76|||=|0.36|TWO_SIDED|95.0|0.42|1.37|||negative-binomial regression|||||1.37|0.42|=0.36
91776014|NCT03413891|183432815|SUPERIORITY||Rate Ratio|0.32|||=|0.03|TWO_SIDED|95.0|0.12|0.89|||negative-binomial regression|||||0.89|0.12|=0.03
91776015|NCT03413891|183432816|SUPERIORITY||Rate Ratio|0.6|||=|0.11|TWO_SIDED|95.0|0.32|1.12|||negative-binomial regression|||||1.12|0.32|=0.11
91776016|NCT03413891|183432817|SUPERIORITY||Rate Ratio|0.42|||=|0.15|TWO_SIDED|95.0|0.13|1.38|||negative-binomial regression|||||1.38|0.13|=0.15
91776017|NCT03413891|183432819|SUPERIORITY||Rate Ratio|0.57|||=|0.37|TWO_SIDED|95.0|0.17|1.91|||negative-binomial regression|||||1.91|0.17|=0.37
91776018|NCT03413891|183432820|SUPERIORITY||Risk Ratio (RR)|0.7|||=|0.66|TWO_SIDED|95.0|0.26|1.91|||Chi-squared|||||1.91|0.26|=0.66
91776019|NCT03413891|183432821|SUPERIORITY||Rate Ratio|0.4|||=|0.04|TWO_SIDED|95.0|0.16|0.98|||negative-binomial regression|||||0.98|0.16|=0.04
91776020|NCT03413891|183432822|SUPERIORITY||Rate Ratio|0.37|||<|0.01|TWO_SIDED|95.0|0.18|0.78|||negative-binomial regression|||||0.78|0.18|<0.01
91776021|NCT00301808|183432859|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier product limit|0.66|STANDARD_ERROR_OF_MEAN|0.1423|||TWO_SIDED|95.0|0.48|0.84||||||||0.84|0.48|
91776022|NCT00844844|183432863|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols:C08-002A (adult) and C08-002B (Adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
91776023|NCT00844844|183432864|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
91776024|NCT00844844|183432865|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
91776025|NCT00844844|183432866|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
91776026|NCT00844844|183432867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
91776027|NCT00844844|183432868|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline was analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
91776028|NCT00844844|183432869|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
91776029|NCT00844844|183432870|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
91776030|NCT00844844|183432871|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
91776031|NCT00844844|183432872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
91520247|NCT01970982|182914667|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.09|||<|0.001|TWO_SIDED|95.0|18.41|28.95||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||28.95|18.41|<0.001
91520248|NCT01970982|182914668|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|52.86|||<|0.001|TWO_SIDED|95.0|45.67|61.17||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||61.17|45.67|<0.001
91520249|NCT01970982|182914669|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|15.68|||<|0.001|TWO_SIDED|95.0|13.09|18.78||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||18.78|13.09|<0.001
91520250|NCT01970982|182914670|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|47.1|||<|0.001|TWO_SIDED|95.0|44.3|50.08||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||50.08|44.30|<0.001
91520251|NCT03364751|182914707|OTHER||LS Mean Difference|0.068||||0.297|TWO_SIDED|95.0|-0.06|0.196|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.196|-0.060|0.297
91520252|NCT03364751|182914707|OTHER||LS Mean Difference|-0.064||||0.55|TWO_SIDED|95.0|-0.273|0.146|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.146|-0.273|0.550
91520253|NCT03364751|182914708|OTHER||LS Mean Difference|0.043||||0.502|TWO_SIDED|95.0|-0.084|0.171|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.171|-0.084|0.502
91520254|NCT03364751|182914708|OTHER||LS Mean Difference|-0.02||||0.851|TWO_SIDED|95.0|-0.229|0.189|||Mixed Models Analysis|||Month 3: Difference between Cigarette and Dual Use||0.189|-0.229|0.851
91520255|NCT03364751|182914709|OTHER||LS Mean Difference|0.07||||0.376|TWO_SIDED|95.0|-0.085|0.224|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.224|-0.085|0.376
91520256|NCT03364751|182914709|OTHER||LS Mean Difference|0.025||||0.848|TWO_SIDED|95.0|-0.229|0.279|||Mixed Models Analysis|||Month 3: Difference between Cigarette and DualUse||0.279|-0.229|0.848
91520257|NCT03364751|182914709|OTHER||LS Mean Difference|0.092||||0.246|TWO_SIDED|95.0|-0.064|0.247|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.247|-0.064|0.246
91520258|NCT03364751|182914709|OTHER||LS Mean Difference|-0.105||||0.417|TWO_SIDED|95.0|-0.359|0.15|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.150|-0.359|0.417
91520259|NCT02413580|182914725|OTHER|The hypothesis test is to test the null hypothesis: H0: μd = 0 versus alternative hypothesis Ha: μd ≠ 0 where μd is the mean change from Baseline to Day 14. The Shapiro-Wilk test is used to test the normality. If the assumptions for parametric test are met, a paired t-test (comparison between the pre- and post-treatment) is used to test for the treatment effect. Otherwise, a non-parametric test (Wilcoxon signed rank test) is used.|Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-7.957|-4.787|||Paired t-test|||||-4.787|-7.957|<0.001
91520260|NCT02342886|182914729|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% confidence interval (CI) for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|9.88|||||TWO_SIDED|95.0|-4.13|23.89|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||23.89|-4.13|
91708150|NCT01134263|183309186|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.085|||||TWO_SIDED|95.0|-0.242|0.073||||||Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1||0.073|-0.242|
91776032|NCT02977403|183432880|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for AB reaction time measures. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. AB reaction times were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-1.948|||||TWO_SIDED|95.0|-20.79|16.894||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in AB, change scores were computed (post-pre = delta). Positive scores represent an increase in AB from pre- to post- intervention. Negative ∆reaction time scores represent a decrease in AB from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in AB following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||16.894|-20.790|
91776033|NCT02977403|183432880|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.952|||||TWO_SIDED|95.0|-35.28|33.377||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||33.377|-35.280|
91776034|NCT02977403|183432881|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficent|0.047|||||TWO_SIDED|95.0|-0.025|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.025|
91776035|NCT02977403|183432881|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.134|||||TWO_SIDED|95.0|-0.288|0.019||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.019|-0.288|
91776036|NCT02977403|183432882|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass and height, race and ethnicity.|beta coefficent|-0.002|||||TWO_SIDED|95.0|-0.085|0.082||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post-intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.082|-0.085|
91776037|NCT02977403|183432882|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.053|||||TWO_SIDED|95.0|-0.177|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.177|
91790166|NCT02660138|183459516|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-10.83||||0.0001|TWO_SIDED|95.0|-16.36|-5.31|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.31|-16.36|0.0001
91708151|NCT01134263|183309187|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.091|||||TWO_SIDED|95.0|-0.009|0.192||||||Dengue Virus Serotype 1||0.192|-0.009|
91520261|NCT02342886|182914730|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|6.62|||||TWO_SIDED|95.0|-2.15|15.4|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||15.40|-2.15|
91520262|NCT03015402|182914738|SUPERIORITY|Pre-randomization characteristics of 2 groups will be presented using the median (IQR) or frequency tables at each study sequence. The difference of mPAP during submax exercise compared between placebo and nitrite at 10 weeks (i.e. week 10 RHC of placebo vs week 10 RHC of nitrite) using parametric PK-cross analysis (i.e. ANOVA to determine the sequence, period, carryover, \& treatment effects). Post-exercise values before \& after crossover will be compared between 2 groups using similar approach.||||||0.2|||||||ANOVA|||||||0.20
91520263|NCT01163097|182914776|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence of the treatments was assessed using the 90% confidence interval (CI) of the geometric mean ratio for Ki67. The lower bound of the CI needed to be greater than 0.70 and the upper bound needed to be below 1.43 for the treatments to be considered equivalent.|Geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.759|0.982|||ANCOVA|ANCOVA was used to estimate the treatment effect and the Schuirmann's two one-sided test was used to test for statistical equivalence.||H0: mean ratio\<0.7 or mean ratio\>1.43; H1: 0.7\< mean ratio \<1.43 Sample size calculation assumed change in Ki67 expression following palifermin administration would not be affected by co-administration of heparin. With n=26 (13 + 13), an approx. 80% probability that the 90% CI of the ratio of geometric means of Ki67 for palifermin when co-administered with heparin compared to palifermin alone would fall in the interval (0.7, 1.43). This assumed a Coefficient of Variation (CV) for Ki67 of 31%.||0.982|0.759|
91520264|NCT01163097|182914778|SUPERIORITY_OR_OTHER||Geometric mean|0.737|||||TWO_SIDED|95.0|0.614|0.885|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 20% increase (or 17% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of amylase would be 14% (as observed in other study)||0.885|0.614|
91520265|NCT01163097|182914779|SUPERIORITY_OR_OTHER||Geometric mean|0.373|||||TWO_SIDED|95.0|0.216|0.645|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 70% increase (or 41% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of lipase would be 49% (as observed in other study)||0.645|0.216|
91520266|NCT01163097|182914780|SUPERIORITY_OR_OTHER||Geometric mean|0.972|||||TWO_SIDED|95.0|0.768|1.231|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 140% increase with 13 and 6 subjects (respectively) when Treatment B was compared to Treatment C; assuming that the coefficient of variation of the protein/creatinine ratio would be 67% (Ginsberg et al 1983)||1.231|0.768|
91520267|NCT01163097|182914781|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
91520268|NCT01163097|182914782|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
91646272|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.0186|TWO_SIDED|95.0|1.07|2.0|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.00|1.07|0.0186
91790167|NCT02660138|183459516|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-12.19|||<|0.0001|TWO_SIDED|95.0|-17.65|-6.73|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-6.73|-17.65|<0.0001
91520269|NCT01163097|182914783|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
91520270|NCT01163097|182914784|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
91520271|NCT01163097|182914785|SUPERIORITY_OR_OTHER|||||||0.4123||90.0|||||ANOVA|||||||0.4123
91520272|NCT01163097|182914786|SUPERIORITY_OR_OTHER|||||||0.9944||90.0|||||ANOVA|||||||0.9944
91520273|NCT01163097|182914787|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
91520274|NCT01163097|182914788|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
91520275|NCT02510144|182914805|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Negative cultures were compared on the treated side vs the non-treated side||||0.68
91520276|NCT02510144|182914805|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Negative cultures were compared on the treated side versus the non-treated side||||<0.01
91520277|NCT00541450|182914816|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.002
91520278|NCT00541450|182914817|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.001
91520279|NCT00541450|182914818|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.16||||||95.0|-0.37|0.05|||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||0.05|-0.37|
91520280|NCT00541450|182914820|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.030
91646273|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.1458|TWO_SIDED|95.0|0.83|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||3.43|0.83|0.1458
91520281|NCT00981084|182914822|SUPERIORITY_OR_OTHER||||||=|0.19||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .19
91776038|NCT02977403|183432883|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.08|||||TWO_SIDED|95.0|-0.022|0.182||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.182|-0.022|
91776039|NCT02977403|183432883|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.018|||||TWO_SIDED|95.0|-0.139|0.103||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.103|-0.139|
91776040|NCT02977403|183432884|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.086|0.113||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.113|-0.086|
91776041|NCT02977403|183432884|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.035|||||TWO_SIDED|95.0|-0.179|0.109||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.109|-0.179|
91776042|NCT02977403|183432885|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.083|||||TWO_SIDED|95.0|-0.001|0.167||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.167|-0.001|
91776043|NCT02977403|183432885|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.069|||||TWO_SIDED|95.0|-0.201|0.063||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.063|-0.201|
91776044|NCT02977403|183432886|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity|beta coefficient|0.031|||||TWO_SIDED|95.0|-0.059|0.121||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.121|-0.059|
91776045|NCT02977403|183432886|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.002|||||TWO_SIDED|95.0|-0.157|0.152||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.152|-0.157|
91646274|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1859|TWO_SIDED|95.0|0.79|3.29|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.29|0.79|0.1859
91520282|NCT00981084|182914822|SUPERIORITY_OR_OTHER||||||=|0.0005||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .0005
91520283|NCT00981084|182914822|SUPERIORITY_OR_OTHER||||||=|0.21||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .21
91520284|NCT00981084|182914822|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .10
91520285|NCT00981084|182914823|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the CPT, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.33
91520286|NCT00981084|182914824|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Stroop, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.37
91520287|NCT00981084|182914825|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Word Generation, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.53
91520288|NCT01112579|182914826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3|TWO_SIDED|95.0|-2.0|14.9|||ANCOVA|||||14.9|-2.0|0.3
91520289|NCT01112579|182914827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.1||||0.79|TWO_SIDED|95.0|-845.8|633.6|||ANCOVA|||||633.6|-845.8|0.79
91520290|NCT01112579|182914828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.93|TWO_SIDED|95.0|-1.6|3.2|||ANCOVA|||||3.2|-1.6|0.93
91520291|NCT03053050|182914874|SUPERIORITY||Percentage Difference|-2.1||||0.4941|TWO_SIDED|95.0|-8.3|4.0||Difference between SEL 18 mg and Placebo, 95% confidence interval (CI) and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and Enhanced Liver Fibrosis (ELF) test score as stratification factors.|Mantel Haenszel|||||4.0|-8.3|0.4941
91520292|NCT03053050|182914874|SUPERIORITY||Percentage Difference|-0.3||||0.9321|TWO_SIDED|95.0|-6.6|6.0||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.0|-6.6|0.9321
91520293|NCT03053050|182914876|SUPERIORITY||Percentage Difference|-4.0||||0.2593|TWO_SIDED|95.0|-10.8|2.9||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.9|-10.8|0.2593
91646275|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0122|TWO_SIDED|95.0|1.13|2.72|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.72|1.13|0.0122
91776046|NCT02977403|183432887|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.042|||||TWO_SIDED|95.0|-0.149|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.149|
91776047|NCT02977403|183432887|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.068|||||TWO_SIDED|95.0|-0.266|0.131||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.131|-0.266|
91790168|NCT02660138|183459517|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|160.9|||<|0.0001|TWO_SIDED|95.0|109.9|211.9|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||211.9|109.9|<0.0001
91776048|NCT02977403|183432888|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.122|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.122|
91776049|NCT02977403|183432888|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.233|0.092||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.092|-0.233|
91776050|NCT02977403|183432889|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.042|||||TWO_SIDED|95.0|-0.041|0.126||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.126|-0.041|
91776051|NCT02977403|183432889|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.252|0.082||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.082|-0.252|
91776052|NCT02977403|183432890|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.06|0.102||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.102|-0.060|
91776053|NCT02977403|183432890|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.071|||||TWO_SIDED|95.0|-0.26|0.119||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.119|-0.260|
91776054|NCT02977403|183432891|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.107|||||TWO_SIDED|95.0|0.03|0.185||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.185|0.030|
91520294|NCT03053050|182914876|SUPERIORITY||Percentage Difference|-0.9||||0.808|TWO_SIDED|95.0|-7.9|6.1||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.1|-7.9|0.8080
91776055|NCT02977403|183432891|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.197|||||TWO_SIDED|95.0|-0.346|-0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.047|-0.346|
91776056|NCT02977403|183432892|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.092|||||TWO_SIDED|95.0|0.01|0.175||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.175|0.010|
91776057|NCT02977403|183432892|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.049|||||TWO_SIDED|95.0|-0.204|0.107||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.107|-0.204|
91776058|NCT02977403|183432893|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.046|||||TWO_SIDED|95.0|-0.032|0.123||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.123|-0.032|
91776059|NCT02977403|183432893|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.007|||||TWO_SIDED|95.0|-0.163|0.177||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.177|-0.163|
91776060|NCT02977403|183432894|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.041|||||TWO_SIDED|95.0|-0.03|0.112||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.112|-0.03|
91520295|NCT03053050|182914878|SUPERIORITY||Percentage Difference|-2.0||||0.5636|TWO_SIDED|95.0|-8.7|4.8||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.8|-8.7|0.5636
91520296|NCT03053050|182914878|SUPERIORITY||Percentage Difference|-1.9||||0.5915|TWO_SIDED|95.0|-8.6|4.9||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.9|-8.6|0.5915
91776061|NCT02977403|183432894|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.014|||||TWO_SIDED|95.0|-0.168|0.14||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.140|-0.168|
91776062|NCT02977403|183432895|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.037|||||TWO_SIDED|95.0|-0.125|0.052||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.052|-0.125|
91776063|NCT02977403|183432895|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.196|0.129||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.129|-0.196|
91776064|NCT02977403|183432896|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.001|||||TWO_SIDED|95.0|-0.091|0.093||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.093|-0.091|
91776065|NCT02977403|183432896|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.286|0.001||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.001|-0.286|
91776066|NCT02977403|183432897|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.065|||||TWO_SIDED|95.0|-0.001|0.132||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.132|-0.001|
91776067|NCT02977403|183432897|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.246|0.055||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.055|-0.246|
91776068|NCT02977403|183432898|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.023|||||TWO_SIDED|95.0|-0.055|0.101||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.101|-0.055|
91520297|NCT03053050|182914880|SUPERIORITY||Percentage Difference|-3.2||||0.2455|TWO_SIDED|95.0|-8.5|2.2||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.2|-8.5|0.2455
91708152|NCT01134263|183309187|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.334|||||TWO_SIDED|95.0|0.202|0.466||||||Dengue Virus Serotype 2||0.466|0.202|
91520298|NCT03053050|182914880|SUPERIORITY||Percentage Difference|-4.0||||0.1371|TWO_SIDED|95.0|-9.3|1.3||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||1.3|-9.3|0.1371
91520299|NCT00251745|182914908|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91520300|NCT00251745|182914908|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91520301|NCT00251745|182914908|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
91520302|NCT00251745|182914910|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
91520303|NCT00251745|182914910|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91520304|NCT00251745|182914910|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
91520305|NCT00636649|182914916|SUPERIORITY_OR_OTHER|||||||0.993|||||||ANCOVA|||CISS-TASK||||0.993
91646276|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0162|TWO_SIDED|95.0|1.1|2.67|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.67|1.10|0.0162
91520306|NCT00636649|182914916|SUPERIORITY_OR_OTHER|||||||0.185|||||||ANCOVA|||CISS-EMOT||||0.185
91520307|NCT00636649|182914916|SUPERIORITY_OR_OTHER|||||||0.196|||||||ANCOVA|||CISS-DIS||||0.196
91520308|NCT00636649|182914916|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||CISS-AVD||||0.759
91646277|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.7573|TWO_SIDED|95.0|0.19|3.36|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||3.36|0.19|0.7573
91520309|NCT00636649|182914916|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANCOVA|||CISS-SOC||||0.396
91520310|NCT00636649|182914917|SUPERIORITY_OR_OTHER|||||||0.579|||||||ANCOVA|||||||0.579
91520311|NCT00636649|182914918|SUPERIORITY_OR_OTHER|||||||0.225|||||||ANCOVA|||TFEQ-RES||||0.225
91520312|NCT00636649|182914918|SUPERIORITY_OR_OTHER|||||||0.498|||||||ANCOVA|||TFEQ-DIS||||0.498
91520313|NCT00636649|182914918|SUPERIORITY_OR_OTHER|||||||0.724|||||||ANCOVA|||TFEQ-HUN||||0.724
91520314|NCT04508699|182914926|OTHER|||||||0.36|||||||t-test, 1 sided|||||||0.36
91520315|NCT04508699|182914927|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
91520316|NCT04508699|182914928|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
91520317|NCT04508699|182914929|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
91520318|NCT04508699|182914930|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
91520319|NCT04508699|182914931|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
91776069|NCT02977403|183432898|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.02|||||TWO_SIDED|95.0|-0.178|0.137||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.137|-0.178|
91776070|NCT02977403|183432899|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.116|0.051||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.051|-0.116|
91776071|NCT02977403|183432899|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.06|||||TWO_SIDED|95.0|-0.104|0.223||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.223|-0.104|
91776072|NCT02977403|183432900|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.012|||||TWO_SIDED|95.0|-0.078|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.078|
91776073|NCT02977403|183432900|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.064|||||TWO_SIDED|95.0|-0.248|0.12||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.120|-0.248|
91776074|NCT02977403|183432901|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.089|||||TWO_SIDED|95.0|0.004|0.174||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.174|0.004|
91776075|NCT02977403|183432901|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.159|0.201||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.201|-0.159|
91776076|NCT02977403|183432902|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.113|0.081||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.081|-0.113|
91776077|NCT02977403|183432902|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.072|||||TWO_SIDED|95.0|-0.206|0.062||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.062|-0.206|
91520320|NCT04508699|182914932|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
91520321|NCT04508699|182914933|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
91520322|NCT02293395|182914942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.584|TWO_SIDED|95.0|0.8|1.5|||Log Rank|||||1.5|0.8|0.584
91776078|NCT02977403|183432903|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.129|||||TWO_SIDED|95.0|0.049|0.209||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.209|0.049|
91776079|NCT02977403|183432903|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.181|||||TWO_SIDED|95.0|-0.33|-0.033||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.033|-0.330|
91776080|NCT02977403|183432904|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.126|||||TWO_SIDED|95.0|0.045|0.207||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.207|0.045|
91776081|NCT02977403|183432904|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.056|||||TWO_SIDED|95.0|-0.223|0.112||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.112|-0.223|
91776082|NCT02977403|183432905|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.115|||||TWO_SIDED|95.0|0.027|0.203||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.203|0.027|
91776083|NCT02977403|183432905|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.058|||||TWO_SIDED|95.0|-0.203|0.087||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.087|-0.203|
91776084|NCT02977403|183432906|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.037|||||TWO_SIDED|95.0|-0.053|0.127||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.127|-0.053|
91776085|NCT02977403|183432906|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.24|0.069||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.069|-0.240|
91520323|NCT01023568|182914962|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|14.0|||>|0.99|TWO_SIDED|95.0|7.0|26.0|||Wilcoxon (Mann-Whitney)||Glidescope - direct laryngoscopy|||26|7|>0.99
91646278|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.7088|TWO_SIDED|95.0|0.18|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.21|0.18|0.7088
91646279|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0787|TWO_SIDED|95.0|0.93|3.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.64|0.93|0.0787
91646280|NCT01236053|183184687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0873|TWO_SIDED|95.0|0.92|3.58|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.58|0.92|0.0873
91520324|NCT01023568|182914962|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|17.0|||>|0.99|TWO_SIDED|95.0|6.0|28.0|||Wilcoxon (Mann-Whitney)||Truview PCD - direct laryngoscopy|||28|6|>0.99
91520325|NCT01023568|182914963|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||||||0.28
91520326|NCT01023568|182914964|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||>|0.99|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||2|1|> 0.99
91520327|NCT01023568|182914964|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||0|0|0.18
91520328|NCT01023568|182914965|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
91520329|NCT01023568|182914966|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
91520330|NCT01106430|182914967|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||95.0|||||Peto-Peto-Prentice Wilcoxon Test|||||||=0.001
91520331|NCT01106430|182914968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.1||||0.001|TWO_SIDED|95.0|7.5|28.7|||Cochran-Mantel-Haenszel|||||28.7|7.5|0.001
91520332|NCT01106430|182914969|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.5|||<|0.001|TWO_SIDED|95.0|-9.3|-3.6|||ANCOVA|||||-3.6|-9.3|<0.001
91520333|NCT01106430|182914970|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.046|TWO_SIDED|95.0|-0.17|0.0|||ANCOVA|||||-0.00|-0.17|0.046
91520334|NCT00297115|182914975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|41.0|75.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||75|41|<0.0001
91520335|NCT00297115|182914976|SUPERIORITY_OR_OTHER||Rate ratio|0.815|STANDARD_ERROR_OF_MEAN|0.057||0.0035|TWO_SIDED|95.0|0.71|0.935||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.935|0.710|0.0035
91520336|NCT00297115|182914977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|61.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|44.0|79.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||79|44|<0.0001
91520337|NCT00297115|182914978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|STANDARD_ERROR_OF_MEAN|0.35||0.5028|TWO_SIDED|95.0|0.689|2.137||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 772 in the roflumilast group, n= 796 in the placebo group).|||2.137|0.689|0.5028
91520338|NCT00297115|182914979|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|1.0593||||0.3627|TWO_SIDED|95.0|0.9356|1.1994||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.1994|0.9356|0.3627
91520339|NCT00297115|182914980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.104||0.0059|TWO_SIDED|95.0|0.082|0.489||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.489|0.082|0.0059
91520340|NCT00175825|182914991|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|9.8|||=|0.24|TWO_SIDED|95.0|-7.2|24.0|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||24.0|-7.2|=0.240
91520341|NCT00175825|182914991|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|14.9|||=|0.062|TWO_SIDED|95.0|-0.8|28.2|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||28.2|-0.8|=0.062
91520342|NCT00175825|182914991|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|22.1|||=|0.004|TWO_SIDED|95.0|7.6|34.3|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||34.3|7.6|=0.004
91646281|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4233|TWO_SIDED|95.0|0.8|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.80|0.4233
91520343|NCT03466086|182915060|SUPERIORITY|This was a pilot study and the sample size was not based on any empirical power calculation.|Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.238|||TWO_SIDED|95.0|-2.35|2.59||Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is greater than 0.|Multivariate Bayesian Model|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.|Mean Difference was calculated as Test minus Control.|||2.59|-2.35|
91520344|NCT03466086|182915061|SUPERIORITY|Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.|Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|0.951|||TWO_SIDED|95.0|-0.4|3.37|||Multivariate Bayesian Analysis|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.||This was a pilot study and the sample size was not based on any empirical power calculation.|Mean difference was calculated as Test - Control|3.37|-0.40|
91520345|NCT01113502|182915062|OTHER||Maximum Tolerated Dose (mg)|300.0|||||TWO_SIDED|||||||||||||
91520346|NCT03440372|182915120|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0049|TWO_SIDED|95.0|1.19|2.7|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.70|1.19|0.0049
91520347|NCT03440372|182915121|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0179|TWO_SIDED|95.0|1.09|2.43|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.43|1.09|0.0179
91520348|NCT03440372|182915122|SUPERIORITY||Odds Ratio (OR)|1.27||||0.272|TWO_SIDED|95.0|0.83|1.93|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||1.93|0.83|0.2720
91520349|NCT03440372|182915123|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0193|TWO_SIDED|95.0|1.07|2.15|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.15|1.07|0.0193
91520350|NCT03440372|182915124|SUPERIORITY||Odds Ratio (OR)|1.28||||0.3167|TWO_SIDED|95.0|0.79|2.05|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.05|0.79|0.3167
91520351|NCT03440372|182915125|SUPERIORITY||Odds Ratio (OR)|1.28||||0.3167|TWO_SIDED|95.0|0.79|2.05|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.05|0.79|0.3167
91520352|NCT03440372|182915126|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2978|TWO_SIDED|95.0|0.73|2.77|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.77|0.73|0.2978
91520353|NCT03440372|182915127|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1895|TWO_SIDED|95.0|0.82|2.72|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.72|0.82|0.1895
91520354|NCT03440372|182915128|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0452|TWO_SIDED|95.0|1.0|2.97|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.97|1.00|0.0452
91520355|NCT03440372|182915129|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0173|TWO_SIDED|95.0|1.08|2.14|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.14|1.08|0.0173
91520356|NCT03440372|182915130|SUPERIORITY||Odds Ratio (OR)|1.46||||0.067|TWO_SIDED|95.0|0.97|2.2|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.20|0.97|0.0670
91520357|NCT03440372|182915131|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0835|TWO_SIDED|95.0|0.95|2.16|||Mantel Haenszel|Cochran-Mantel-Haenszel (CMH) test||||2.16|0.95|0.0835
91520358|NCT05711641|182915132|OTHER|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|Generalized Estimating Equations|||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
91520359|NCT05711641|182915133|OTHER|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
91520360|NCT05711641|182915134|OTHER|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
91520361|NCT03574597|182915135|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.72|0.89|||Regression, Cox|||Data from the in-trial period. The outcome measure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Participants without events of interest were censored at the end of their in-trial period.||0.89|0.72|< 0.0001
91520362|NCT01215292|182915197|NON_INFERIORITY_OR_EQUIVALENCE|80% power to detect 20% difference in ITT|||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
91520363|NCT01215292|182915198|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
91520364|NCT01215292|182915199|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
91520365|NCT01596582|182915216|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
91520366|NCT01596582|182915217|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
91646282|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5908|TWO_SIDED|95.0|0.76|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.76|0.5908
91520367|NCT01596582|182915218|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91520368|NCT01596582|182915219|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91520369|NCT01596582|182915220|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91520370|NCT01596582|182915221|SUPERIORITY||||||>|0.05||||||The p-value for each comparison was non-significanct.|Wilcoxon (Mann-Whitney)|||||||>0.05
91520371|NCT01596582|182915222|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
91520372|NCT01596582|182915223|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
91520373|NCT01596582|182915224|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91520374|NCT01596582|182915225|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
91520375|NCT01786967|182915229|SUPERIORITY|This was a pilot study to provide preliminary data to inform future sample size estimates for a larger more definitive trial|Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.53|1.71|||Fisher Exact|||Null hypothesis was that there will be no difference in treatment benefit scale between the two groups||1.71|0.53|1.0
91520376|NCT01786967|182915230|SUPERIORITY||Risk Ratio (RR)|0.85||||1|TWO_SIDED|95.0|0.76|0.95|||Fisher Exact|||Null hypothesis was that there was no difference in the rate of moderate to severe adverse events.||.95|.76|1.0
91520377|NCT00182754|182915255|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
91520378|NCT02816138|182915284|OTHER||||||<|0.001|||||||Regression, Linear|For change in depression severity (MADRS) over time, we used a linear mixed effects model with autoregressive of order 1 (AR(1)) temporal process.||||||<0.001
91520379|NCT02816138|182915285|OTHER|||||||0.761|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.761
91520380|NCT02816138|182915286|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.084
91520381|NCT02816138|182915287|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.073
91520382|NCT02816138|182915288|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.002
91520383|NCT02816138|182915289|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
91520384|NCT02816138|182915290|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.049
91520385|NCT02816138|182915291|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.502
91520386|NCT02816138|182915292|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.049
91646283|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.054|TWO_SIDED|95.0|1.0|1.67|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.67|1.00|0.0540
91520387|NCT02816138|182915293|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.068
91520388|NCT00818753|182915294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.08|12.76||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 110mg BID vs Heparin||12.76|0.08|
91520389|NCT00818753|182915294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||||95.0|0.13|16.82||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 150mg BID vs Heparin||16.82|0.13|
91520390|NCT00902694|182915299|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.6|-0.4||||||6 month intervention versus control||-0.4|-2.6|
91520391|NCT00902694|182915299|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.1|-1.2||||||18 month intervention versus control||-1.2|-5.1|
91520392|NCT00902694|182915301|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-3.6|-0.4||||||6 month intervention versus control||-0.4|-3.6|
91646284|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.96|0.0939
91520393|NCT00902694|182915301|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.1|0.3||||||18 month intervention versus control||0.3|-4.1|
91520394|NCT00902694|182915302|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-3.2|2.4||||||6 month systolic intervention versus control||2.4|-3.2|
91520395|NCT00902694|182915302|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.6|2.1||||||6 month diastolic intervention versus control||2.1|-1.6|
91520396|NCT00902694|182915302|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.6|4.8||||||18 month systolic intervention versus control||4.8|-1.6|
91520397|NCT00902694|182915302|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.9|3.4||||||18 month diastolic intervention versus control||3.4|-0.9|
91520398|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-9.9|4.1||||||6 month total chol intervention versus control||4.1|-9.9|
91520399|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|95.0|-14.9|4.4||||||18 month total chol intervention versus control||4.4|-14.9|
91520400|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-7.5|5.1||||||6 month LDL chol intervention versus control||5.1|-7.5|
91520401|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|95.0|-13.1|3.9||||||18 month LDL chol intervention versus control||3.9|-13.1|
91520402|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7||||||6 month HDL chol intervention versus control||1.7|-2.9|
91520403|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-1.8|3.1||||||18 month HDL intervention versus control||3.1|-1.8|
91520404|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-5.5|||||TWO_SIDED|95.0|-23.5|12.4||||||6 month TRIG intervention versus control||12.4|-23.5|
91520405|NCT00902694|182915303|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-27.0|23.9||||||18 month TRIG intervention versus control||23.9|-27.0|
91520406|NCT04154787|182915314|SUPERIORITY|Comparison of adjusted geometric mean ratios on Day 169|Adjusted geometric mean ratio|1.37||||0.267|TWO_SIDED|95.0|0.9|2.08||Calculated at one-sided 10% level from a lower-tailed test|Mixed Models Analysis|||||2.08|0.90|0.2670
91520407|NCT04154787|182915317|SUPERIORITY||Adjusted geometric mean ratios|0.81||||0.4598|TWO_SIDED|95.0|0.47|1.42||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 15||1.42|0.47|0.4598
91520408|NCT04154787|182915317|SUPERIORITY||Geometric mean ratios|1.3||||0.4528|TWO_SIDED|95.0|0.65|2.61||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 169||2.61|0.65|0.4528
91520409|NCT02459574|182915330|SUPERIORITY||Hazard Ratio (HR)|0.156|||<|0.0001|TWO_SIDED|95.0|0.097|0.25||Bonferonni corrected alpha of 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Anti-Arrhythmic Therapy|Primary Analysis - AVATAR-AF vs Anti-Arrhythmic Therapy||0.250|0.097|<0.0001
91520410|NCT02459574|182915330|SUPERIORITY||Hazard Ratio (HR)|1.173||||0.6061|TWO_SIDED|95.0|0.639|2.154||Bonferonni corrected alpha 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Conventional Ablation|Secondary analysis of Primary Outcome measure - AVATAR-AF vs Conventional Ablation||2.154|0.639|0.6061
91520411|NCT01337674|182915357|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-8.42|5.98|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||5.98|-8.42|
91520412|NCT01337674|182915357|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|2.29|||||TWO_SIDED|90.0|-4.92|9.49|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||9.49|-4.92|
91520413|NCT01337674|182915357|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|1.65|||||TWO_SIDED|90.0|-5.31|8.62|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||8.62|-5.31|
91520414|NCT01337674|182915357|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-8.06|5.88|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||5.88|-8.06|
91520415|NCT01337674|182915358|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|1.95|||||TWO_SIDED|90.0|-2.85|6.75|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||6.75|-2.85|
91520416|NCT01337674|182915358|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-5.91|||||TWO_SIDED|90.0|-10.71|-1.11|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||-1.11|-10.71|
91520417|NCT01337674|182915358|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-6.25|||||TWO_SIDED|90.0|-11.47|-1.03|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||-1.03|-11.47|
91520418|NCT01337674|182915358|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-1.57|||||TWO_SIDED|90.0|-6.79|3.65|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||3.65|-6.79|
91520419|NCT01787097|182915366|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91646285|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.214|TWO_SIDED|95.0|0.87|1.87|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.87|0.87|0.2140
91646286|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.8|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.80|0.84|0.2940
91520420|NCT00224770|182915392|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|6.6||0.324|ONE_SIDED|95.0||16.2|||Fisher Exact|One-sided test|MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.||16.2||0.324
91520421|NCT00224770|182915392|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|8.2||0.633|ONE_SIDED|95.0||11.2|||Fisher Exact|One-sided test|ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.||11.2||0.633
91520422|NCT00224770|182915393|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.6|STANDARD_ERROR_OF_MEAN|3.1||0.174|ONE_SIDED|95.0||11.7|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.||11.7||0.174
91520423|NCT00224770|182915394|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.437|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.||1.5||0.437
91520424|NCT00224770|182915394|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.||1.5||0.750
91646287|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8352|TWO_SIDED|95.0|0.71|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.32|0.71|0.8352
91520425|NCT00224770|182915395|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2|STANDARD_ERROR_OF_MEAN|3.9||0.409|ONE_SIDED|95.0||9.6|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.||9.6||0.409
91520426|NCT00224770|182915395|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||2.2|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.||2.2||0.750
91520427|NCT00224770|182915396|SUPERIORITY_OR_OTHER|||||||0.468|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.468
91520428|NCT00224770|182915396|SUPERIORITY_OR_OTHER|||||||0.294|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.294
91520429|NCT00224770|182915397|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.395
91520430|NCT00224770|182915397|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.175
91520431|NCT00224770|182915398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
91520432|NCT00224770|182915398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
91790169|NCT02660138|183459517|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|189.2|||<|0.0001|TWO_SIDED|95.0|140.1|238.2|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||238.2|140.1|<0.0001
91520433|NCT00224770|182915399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign test|Two-sided test||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||<0.0001
91520434|NCT00224770|182915399|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Sign test|Two-sided||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||0.791
91520435|NCT00224770|182915400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|9.5||0.189|ONE_SIDED|95.0||26.6|||Fisher Exact|One-sided test|MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.||26.6||0.189
91520436|NCT00224770|182915400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.2|STANDARD_ERROR_OF_MEAN|14.9||0.156|ONE_SIDED|95.0||43.7|||Fisher Exact|One-sided test|ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.||43.7||0.156
91520437|NCT00437645|182915401|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis for non-inferiority of valsartan/amlodipine 160/5 mg to amlodipine 10 mg alone with a non-inferiority margin of 3 mm Hg|Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.0|-0.44|||ANCOVA|||||-0.44|-3.00|
91520438|NCT02713711|182915421|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.3262|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.3262
91520439|NCT02713711|182915421|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.01|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.01
91520440|NCT02713711|182915421|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.0646|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.0646
91520441|NCT02713711|182915421|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.|||||<|0.001|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||<0.001
91520442|NCT02713711|182915421|SUPERIORITY|Two-way ANOVA (Bonferroni post-test) for intergroup analysis.|||||<|0.001|||||||ANOVA|||||||<0.001
91520443|NCT02713711|182915422|SUPERIORITY|paired-t test (intragroup analysis)||||||0.208|||||||t-test, 2 sided|||||||0.2080
91520444|NCT02713711|182915422|SUPERIORITY|paired-t test (intragroup analysis)||||||0.0136|||||||t-test, 2 sided|||||||0.0136
91520445|NCT02713711|182915422|SUPERIORITY|paired-t test (intragroup analysis)||||||0.2987|||||||t-test, 2 sided|||||||0.2987
91520446|NCT02713711|182915422|SUPERIORITY|paired-t test (intragroup analysis)||||||0.8347|||||||t-test, 2 sided|||||||0.8347
91520447|NCT02713711|182915422|SUPERIORITY|two-way ANOVA with Bonferroni post hoc test (intergroup analysis)||||||0.0001|||||||ANOVA|||||||0.0001
91520448|NCT02274857|182915483|SUPERIORITY|||||||0.2179|||||||Chi-squared|||||||0.2179
91520449|NCT02274857|182915484|SUPERIORITY|||||||0.2782|||||||Chi-squared|||||||0.2782
91520450|NCT02274857|182915485|SUPERIORITY|||||||0.7266|||||||Chi-squared|||||||0.7266
91520451|NCT02274857|182915486|SUPERIORITY|||||||0.3522|||||||Chi-squared|||||||0.3522
91520452|NCT00117676|182915488|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 200 subjects in the tenofovir DF group and 100 subjects in the adefovir dipivoxil group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the tenofovir DF treatment was inferior to the adefovir dipivoxil treatment (difference in proportions was less than -0.100) in favor of the alternative hypothesis that the tenofovir DF treatment was not inferior.|Difference in proportions|23.5|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|13.2|33.8||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≥ 2 x ULN or \> 2 x ULN) difference is 0.|Z-test|||A two-sided 95% confidence interval (CI), stratified by baseline ALT (≤ 2 x ULN or \> 2 x ULN) was used to evaluate the difference (tenofovir DF - adefovir dipivoxil) in the proportion of complete responders between treatment groups.||33.8|13.2|<0.001
91520453|NCT00117676|182915489|SUPERIORITY_OR_OTHER||Difference in proportions|30.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|21.3|39.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 2 x ULN or \> 2 x ULN).|Z-test|||||39.2|21.3|<0.001
91520454|NCT00117676|182915490|SUPERIORITY_OR_OTHER||Difference in proportions|1.4|STANDARD_ERROR_OF_MEAN|3.4||0.672|TWO_SIDED|95.0|-5.2|8.0||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Two-sided 95% confidence intervals, stratified by baseline ALT (baseline ALT ≤ 2 x ULN, \> 2 x ULN), were used to evaluate treatment arm differences.|Z-test|||||8.0|-5.2|0.672
91520455|NCT00117676|182915495|SUPERIORITY_OR_OTHER||Difference in proportions|5.2|STANDARD_ERROR_OF_MEAN|5.0||0.293|TWO_SIDED|95.0|-4.5|14.9||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Confidence interval stratum adjusted based on baseline ALT (≤ 2 x ULN, \> 2 x ULN).|Z-test|||||14.9|-4.5|0.293
91520456|NCT00117676|182915501|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|STANDARD_ERROR_OF_MEAN|4.8||0.859|TWO_SIDED|95.0|-10.2|8.5||Statistical tests were not adjusted for baseline ALT stratum. Analysis set included only randomized and treated participants with baseline ALT \> ULN (biochemically evaluable analysis set).|Z-test|P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.||||8.5|-10.2|0.859
91520457|NCT00117676|182915502|SUPERIORITY_OR_OTHER||Difference in proportions|4.9|STANDARD_ERROR_OF_MEAN|5.3||0.359|TWO_SIDED|95.0|-5.5|15.3||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and confidence interval are stratum adjusted (baseline ALT ≤ 2 x ULN or \> 2 x ULN).||||15.3|-5.5|0.359
91520458|NCT00952822|182915520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.052||||||90.0|-0.117|0.012||||||||0.012|-0.117|
91520459|NCT00952822|182915521|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.016||||||90.0|-0.076|0.043||||||||0.043|-0.076|
91520460|NCT01250990|182915552|SUPERIORITY_OR_OTHER|||||||0.8||||||p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.|t-test, 2 sided|||This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.||||0.8
91520461|NCT03786952|182915553|SUPERIORITY|||||||0.453|||||||ANOVA|||||||0.453
91520462|NCT03786952|182915554|SUPERIORITY|||||||0.931|||||||ANOVA|||||||0.931
91520463|NCT03786952|182915555|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
91520464|NCT03786952|182915556|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
91520465|NCT03786952|182915557|SUPERIORITY|||||||0.872|||||||ANOVA|||||||0.872
91520466|NCT03786952|182915558|SUPERIORITY|||||||0.998|||||||ANOVA|||||||0.998
91520467|NCT03786952|182915559|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
91520468|NCT03786952|182915560|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
91520469|NCT03786952|182915561|SUPERIORITY|||||||0.519|||||||ANOVA|||||||0.519
91520470|NCT03786952|182915562|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
91520471|NCT03786952|182915563|SUPERIORITY|||||||0.457|||||||ANOVA|||||||0.457
91520472|NCT03786952|182915564|SUPERIORITY|||||||0.415|||||||ANOVA|||||||0.415
91520473|NCT03786952|182915565|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
91520474|NCT03786952|182915566|SUPERIORITY|||||||0.981|||||||ANOVA|||||||0.981
91520475|NCT03786952|182915567|SUPERIORITY|||||||0.627|||||||ANOVA|||||||0.627
91520476|NCT03786952|182915568|SUPERIORITY|||||||0.901|||||||ANOVA|||||||0.901
91520477|NCT03786952|182915569|SUPERIORITY|||||||0.166|||||||ANOVA|||||||0.166
91520478|NCT03786952|182915570|SUPERIORITY|||||||0.252|||||||ANOVA|||||||0.252
91520479|NCT03292146|182915583|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
91520480|NCT03292146|182915584|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91520481|NCT03292146|182915585|SUPERIORITY|||||||0.06|||||||Matched pairs|||||||0.06
91520482|NCT03292146|182915585|SUPERIORITY|||||||0.01|||||||Matched pairs|||||||0.01
91520483|NCT03905330|182915601|SUPERIORITY||Least-Square mean|-1.089|STANDARD_ERROR_OF_MEAN|0.3691|=|0.0063|TWO_SIDED|95.0|-1.845|-0.334|||Mixed Models Analysis|||The difference between maralixibat and placebo treatment groups in the mean change in the average ItchRO(Obs) severity score between baseline and Weeks 15-26||-0.334|-1.845|= 0.0063
91520484|NCT03905330|182915602|SUPERIORITY||Least-Square mean|-186.723|STANDARD_ERROR_OF_MEAN|51.9501|=|0.0013|TWO_SIDED|95.0|-293.454|-79.992|||Mixed Models Analysis|||||-79.992|-293.454|= 0.0013
91520485|NCT03905330|182915603|SUPERIORITY||Least-Square mean|-1.2|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|95.0|-1.727|-0.674|||Mixed Models Analysis|||||-0.674|-1.727|< 0.0001
91520486|NCT03905330|182915604|SUPERIORITY||Least-Square mean|-160.403|STANDARD_ERROR_OF_MEAN|30.1827|<|0.0001|TWO_SIDED|95.0|-220.836|-99.97|||Mixed Models Analysis|||||-99.970|-220.836|< 0.0001
91520487|NCT03905330|182915605|OTHER||||||=|0.0736|||||||Bernard's exact test|||||||= 0.0736
91520488|NCT03905330|182915606|SUPERIORITY||||||=|0.041|||||||Bernard's exact test|||||||= 0.0410
91520489|NCT03905330|182915607|SUPERIORITY||||||=|0.0023|||||||Bernard's exact test|||||||= 0.0023
91520490|NCT03905330|182915608|SUPERIORITY||||||=|0.0004|||||||Bernard's exact test|||||||= 0.0004
91581648|NCT01190514|183053268|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|115.54|||||TWO_SIDED|90.0|108.59|122.94|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||122.94|108.59|
91581649|NCT00706433|183053297|SUPERIORITY_OR_OTHER|||||||0.768||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.7680
91581650|NCT00706433|183053298|SUPERIORITY_OR_OTHER|||||||0.7975||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7975
91581651|NCT00706433|183053299|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
91581652|NCT00706433|183053300|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
91581653|NCT00706433|183053302|SUPERIORITY_OR_OTHER|||||||0.1103||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.1103
91520491|NCT03624504|182915628|OTHER|Assume expected performance to be 94%. The Objective Performance Criterion (OPC) is set at 83% (same performance threshold in FDA approved global study). Assumes 0.05 significance level, 2-sided, 80% power and 10% study attrition.|Kaplan-Meier survival probability (%)|97.6||||0.0021|TWO_SIDED|95.0|90.6|99.4||The threshold for significance was 0.05.|z test, 1-sided||The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||99.4|90.6|0.0021
91520492|NCT01812655|182915637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.7||||0.029|TWO_SIDED|95.0|2.4|45.0|||Regression, Linear||Mean difference = PD group - VR group|||45.0|2.4|0.029
91520493|NCT01812655|182915637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.32|TWO_SIDED|95.0|-9.5|28.9|||Regression, Linear||Mean difference = VR group - SC group|||28.9|-9.5|0.32
91520494|NCT01812655|182915638|SUPERIORITY_OR_OTHER||Semipartial correlation|0.223||||0.26||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC State Anxiety measured at Baseline for all participants|||||.26
91520495|NCT01812655|182915638|SUPERIORITY_OR_OTHER||Semipartial correlation|0.119||||0.59||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||.59
91520496|NCT01812655|182915638|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.059||||0.6||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants|||||.60
91520497|NCT01812655|182915639|SUPERIORITY_OR_OTHER||semipartial correlation|-0.276||||0.15||95.0|||||Semipartial Correlation||Semipartial correlation between Engagement with Distraction and STAIC State Anxiety measured at Baseline for all participants|||||0.15
91520498|NCT01812655|182915639|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.347||||0.18||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||0.18
91520499|NCT01812655|182915639|SUPERIORITY_OR_OTHER||Semipartial correlation|0.21||||0.054||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants|||||0.054
91520500|NCT01812655|182915639|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.102||||0.61||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants|||||0.61
91520501|NCT01812655|182915639|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.622||||0.007||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants|||||0.007
91520502|NCT01812655|182915639|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.217||||0.045||95.0|||||Semipartial correlation||Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants|||||0.045
91520503|NCT00419263|182915657|SUPERIORITY_OR_OTHER|||||||0.377|TWO_SIDED||||||Regression, Cox|P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.||||||0.377
91520504|NCT00419263|182915658|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.007
91581654|NCT00706433|183053303|SUPERIORITY_OR_OTHER|||||||0.7228||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7228
91581655|NCT00706433|183053304|SUPERIORITY_OR_OTHER|||||||0.3416||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates||||0.3416
91520505|NCT00419263|182915659|SUPERIORITY_OR_OTHER|||||||0.537|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.537
91520506|NCT00419263|182915660|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.002
91581656|NCT00706433|183053305|SUPERIORITY_OR_OTHER|||||||0.5759||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5759
91581657|NCT00706433|183053306|SUPERIORITY_OR_OTHER|||||||0.4754||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4754
91581658|NCT00706433|183053307|SUPERIORITY_OR_OTHER|||||||0.4096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4096
91520507|NCT00419263|182915661|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||< 0.001
91520508|NCT00419263|182915662|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.409
91520509|NCT00419263|182915663|SUPERIORITY_OR_OTHER|||||||0.327|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.327
91520510|NCT00540124|182915665|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.073
91520511|NCT00540124|182915665|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.186
91520512|NCT00540124|182915666|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
91520513|NCT00540124|182915666|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
91520514|NCT00540124|182915666|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.108
91520515|NCT00540124|182915666|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.112
91520516|NCT00540124|182915667|SUPERIORITY_OR_OTHER|||||||0.137||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.137
91520517|NCT00540124|182915667|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.009
91520518|NCT00540124|182915667|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.118
91520519|NCT00540124|182915667|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.018
91520520|NCT00540124|182915667|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.207
91520521|NCT00540124|182915667|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.581
91520522|NCT00540124|182915668|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.306
91520523|NCT00540124|182915668|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
91520524|NCT00540124|182915668|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.203
91520525|NCT00540124|182915668|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.464
91520526|NCT00540124|182915668|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.169
91520527|NCT00540124|182915668|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.243
91520528|NCT00540124|182915669|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.206
91520529|NCT00540124|182915669|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.457
91646288|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.7809|TWO_SIDED|95.0|0.7|1.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.31|0.70|0.7809
91646289|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0921|TWO_SIDED|95.0|0.95|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.94|0.95|0.0921
91790170|NCT02660138|183459518|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-16.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-16.4|-32.3|<0.0001
91520530|NCT00540124|182915669|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.892
91520531|NCT00540124|182915669|SUPERIORITY_OR_OTHER|||||||0.593||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.593
91520532|NCT00540124|182915669|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.887
91520533|NCT00540124|182915669|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
91520534|NCT00540124|182915670|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.691
91520535|NCT00540124|182915670|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.415
91520536|NCT00540124|182915671|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.176
91520537|NCT00540124|182915671|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.921
91520538|NCT00540124|182915672|SUPERIORITY_OR_OTHER|||||||0.429||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.429
91520539|NCT00540124|182915672|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.304
91520540|NCT00540124|182915673|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.254
91646290|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1091|TWO_SIDED|95.0|0.94|1.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.92|0.94|0.1091
91646291|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.0564|TWO_SIDED|95.0|0.99|1.68|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.68|0.99|0.0564
91646292|NCT01236053|183184688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.63|0.96|0.0939
91520541|NCT00540124|182915673|SUPERIORITY_OR_OTHER|||||||0.359||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.359
91520542|NCT00540124|182915673|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.098
91520543|NCT00540124|182915673|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.632
91520544|NCT00540124|182915673|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.102
91520545|NCT00540124|182915673|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.348
91520546|NCT00540124|182915674|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.208
91520547|NCT00540124|182915674|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.985
91776086|NCT02977403|183432907|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.021|||||TWO_SIDED|95.0|-0.092|0.05||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.050|-0.092|
91776087|NCT02977403|183432907|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.249|0.056||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.056|-0.249|
91776088|NCT02977403|183432908|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.095|0.069||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.069|-0.095|
91776089|NCT02977403|183432908|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.078|||||TWO_SIDED|95.0|-0.227|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.227|
91776090|NCT02977403|183432909|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.005|||||TWO_SIDED|95.0|-0.103|0.092||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.092|-0.103|
91776091|NCT02977403|183432909|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.173|0.11||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.110|-0.173|
91790171|NCT02660138|183459518|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.2|-21.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-21.1|-36.2|<0.0001
91520548|NCT00540124|182915675|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.385
91520549|NCT00540124|182915675|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.595
91520550|NCT00540124|182915675|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.704
91520551|NCT00540124|182915675|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.439
91520552|NCT00540124|182915676|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.838
91520553|NCT00540124|182915676|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.831
91520554|NCT00540124|182915676|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.696
91646293|NCT01236053|183184689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.3082|TWO_SIDED|95.0|0.31|41.71|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||41.71|0.31|0.3082
91790172|NCT02660138|183459519|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|155.5|||<|0.0001|TWO_SIDED|95.0|100.5|210.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||210.4|100.5|<0.0001
91790173|NCT02660138|183459519|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|181.8|||<|0.0001|TWO_SIDED|95.0|129.2|234.3|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||234.3|129.2|<0.0001
91520555|NCT00540124|182915676|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.257
91520556|NCT00540124|182915677|SUPERIORITY_OR_OTHER|||||||0.709||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.709
91520557|NCT00540124|182915677|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.494
91520558|NCT02291679|182915698|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.76|5.2||P-value is obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% confidence interval (CI) for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||5.20|1.76|< 0.0001
91520559|NCT02291679|182915699|SUPERIORITY||LS Mean Difference|0.841|||<|0.0001|TWO_SIDED|95.0|0.505|1.176||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.176|0.505|< 0.0001
91520560|NCT02291679|182915700|SUPERIORITY||LS Mean Difference|1.037|||<|0.0001|TWO_SIDED|95.0|0.636|1.438||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.438|0.636|< 0.0001
91520561|NCT02291679|182915701|SUPERIORITY||LS Mean Difference|0.628|||<|0.0001|TWO_SIDED|95.0|0.45|0.806||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.806|0.450|< 0.0001
91520562|NCT02291679|182915702|SUPERIORITY||LS Mean Difference|-0.329|||<|0.0001|TWO_SIDED|95.0|-0.449|-0.21||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.210|-0.449|< 0.0001
91520563|NCT02291679|182915703|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0008|TWO_SIDED|95.0|1.47|4.87||P-value is obtained from the CMH tests controlling for geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region.|||4.87|1.47|0.0008
91520564|NCT02291679|182915704|SUPERIORITY||Odds Ratio (OR)|2.58|||<|0.0001|TWO_SIDED|95.0|1.58|4.2||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||4.20|1.58|< 0.0001
91520565|NCT02291679|182915705|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0002|TWO_SIDED|95.0|1.42|3.26||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||3.26|1.42|0.0002
91520566|NCT02291679|182915706|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0342|TWO_SIDED|95.0|1.03|2.17||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||2.17|1.03|0.0342
91520567|NCT02291679|182915707|SUPERIORITY||LS Mean Difference|-0.319||||0.0063|TWO_SIDED|95.0|-0.548|-0.09||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.090|-0.548|0.0063
91520568|NCT02291679|182915708|SUPERIORITY||LS Mean Difference|-0.178||||0.1028|TWO_SIDED|95.0|-0.391|0.036||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.036|-0.391|0.1028
91776092|NCT02977403|183432910|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.02|||||TWO_SIDED|95.0|-0.069|0.109||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.109|-0.069|
91776093|NCT02977403|183432910|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.088|||||TWO_SIDED|95.0|-0.252|0.077||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.077|-0.252|
91776094|NCT02977403|183432911|OTHER|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.099|0.08||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.080|-0.099|
91776095|NCT02977403|183432911|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.155|||||TWO_SIDED|95.0|-0.294|-0.017||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.017|-0.294|
91776096|NCT02977403|183432912|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.069|0.095||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.095|-0.069|
91776097|NCT02977403|183432912|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.216|0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.047|-0.216|
91776098|NCT02977403|183432913|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.041|||||TWO_SIDED|95.0|-0.123|0.041||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.041|-0.123|
91776099|NCT02977403|183432913|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.213|0.021||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.021|-0.213|
91520569|NCT02291679|182915709|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0001|TWO_SIDED|95.0|1.61|4.8||P-value is obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||4.80|1.61|0.0001
91520570|NCT02276222|182915732|SUPERIORITY||Least Squares Mean (SE)|0.0084|STANDARD_ERROR_OF_MEAN|0.01012||0.4041|TWO_SIDED|95.0|-0.0114|0.0283|||ANCOVA|||||0.0283|-0.0114|0.4041
91776100|NCT02977403|183432914|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.038|||||TWO_SIDED|95.0|-0.142|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.142|
91776101|NCT02977403|183432914|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.29|0.097||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.097|-0.290|
91776102|NCT02977403|183432915|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.023|||||TWO_SIDED|95.0|-0.105|0.059||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.059|-0.105|
91776103|NCT02977403|183432915|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.124|||||TWO_SIDED|95.0|-0.277|0.029||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.029|-0.277|
91776104|NCT02977403|183432916|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.057|||||TWO_SIDED|95.0|-0.14|0.027||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.027|-0.140|
91776105|NCT02977403|183432916|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.161|||||TWO_SIDED|95.0|-0.302|-0.02||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.020|-0.302|
91776106|NCT02977403|183432917|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.0002|||||TWO_SIDED|95.0|-0.091|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.091|
91776107|NCT02977403|183432917|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.004|||||TWO_SIDED|95.0|-0.157|0.149||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.149|-0.157|
91790174|NCT02660138|183459520|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|9.83||||0.0006|TWO_SIDED|95.0|2.72|35.6|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||35.60|2.72|0.0006
91790175|NCT02660138|183459520|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|10.99||||0.0003|TWO_SIDED|95.0|3.05|39.61|||GLMM|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||39.61|3.05|0.0003
91581659|NCT00706433|183053308|SUPERIORITY_OR_OTHER|||||||0.5812||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5812
91581660|NCT00706433|183053309|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8679
91776108|NCT02977403|183432918|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.092|0.071||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.071|-0.092|
91776109|NCT02977403|183432918|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.029|||||TWO_SIDED|95.0|-0.126|0.183||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.183|-0.126|
91776110|NCT02977403|183432919|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.101|0.076||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.076|-0.101|
91776111|NCT02977403|183432919|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.273|0.06||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.060|-0.273|
91776112|NCT02977403|183432920|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.033|||||TWO_SIDED|95.0|-0.11|0.043||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.043|-0.110|
91776113|NCT02977403|183432920|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.166|||||TWO_SIDED|95.0|-0.335|0.003||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.003|-0.335|
91790176|NCT02660138|183459521|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|5.73||||0.001|TWO_SIDED|95.0|2.02|16.24|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||16.24|2.02|0.0010
91790177|NCT02660138|183459521|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|16.08|||<|0.0001|TWO_SIDED|95.0|5.82|44.43|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||44.43|5.82|<0.0001
91581661|NCT00706433|183053310|SUPERIORITY_OR_OTHER|||||||0.3666||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3666
91581662|NCT00706433|183053311|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
91581663|NCT00706433|183053312|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581664|NCT00706433|183053313|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581665|NCT00706433|183053314|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581666|NCT00706433|183053315|SUPERIORITY_OR_OTHER|||||||0.3916||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3916
91581667|NCT00706433|183053316|SUPERIORITY_OR_OTHER|||||||0.8387||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8387
91581668|NCT00706433|183053317|SUPERIORITY_OR_OTHER|||||||0.1489||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1489
91581669|NCT00706433|183053318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
91581670|NCT00706433|183053318|SUPERIORITY_OR_OTHER|||||||0.4143||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4143
91581671|NCT00706433|183053318|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
91581672|NCT00706433|183053318|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0003
91581673|NCT00706433|183053318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
91646294|NCT01236053|183184689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3999|TWO_SIDED|95.0|0.24|34.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||34.69|0.24|0.3999
91646295|NCT01236053|183184689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.7509|TWO_SIDED|95.0|0.16|12.52|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||12.52|0.16|0.7509
91646296|NCT01236053|183184689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.6303|TWO_SIDED|95.0|0.18|17.07|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||17.07|0.18|0.6303
91581674|NCT00706433|183053318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
91581675|NCT00706433|183053318|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9700
91581676|NCT00706433|183053319|SUPERIORITY_OR_OTHER|||||||0.2544||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2544
91581677|NCT00706433|183053320|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4321
91581678|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.0317||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0317
91581679|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.5818||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5818
91581680|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.0395||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0395
91581681|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.7426||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7426
91581682|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0029
91581683|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.2142||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2142
91581684|NCT00706433|183053321|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0781
91581685|NCT00706433|183053322|SUPERIORITY_OR_OTHER|||||||0.9886||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9886
91646297|NCT01236053|183184690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
91520571|NCT02170025|182915733|OTHER||Bayesian analysis|-1.3|||||TWO_SIDED|90.0|-8.7|6.0||||||Treatment effect describes the difference in outcomes between 0.5 mg riociguat and placebo on Day 14. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||6.0|-8.7|
91520572|NCT02170025|182915733|OTHER||Bayesian analysis|-5.0|||||TWO_SIDED|90.0|-12.4|2.4||||||Treatment effect describes the difference in outcomes between 1.0 mg riociguat and placebo on Day 28. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||2.4|-12.4|
91520573|NCT01031810|182915748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_DEVIATION|10.81||0.012|TWO_SIDED|95.0|3.25|19.86|||paired t-test 2 sided|||Compare the mean differences between baseline (week00) and week12 hamd17 summary scores||19.86|3.25|0.012
91520574|NCT00506493|182915777|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportions|42.6|STANDARD_ERROR_OF_MEAN|6.3|<|0.01|ONE_SIDED|97.5|30.0|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percent of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||30.0|<0.01
91520575|NCT00506493|182915778|SUPERIORITY_OR_OTHER_LEGACY||binomial proportions|6.7|||<|0.0001|ONE_SIDED|97.5||14.9|||Fisher Exact|||||14.9||<0.0001
91520576|NCT02532179|182915783|SUPERIORITY||Mean Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.09|4.29||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||4.29|2.09|<0.001
91520577|NCT02532179|182915784|SUPERIORITY||Mean Ratio|3.82|||<|0.001|TWO_SIDED|95.0|2.77|5.25||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||5.25|2.77|<0.001
91520578|NCT02532179|182915785|SUPERIORITY||Mean Ratio|6.55|||<|0.001|TWO_SIDED|95.0|3.87|11.06||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||11.06|3.87|<0.001
91520579|NCT04958785|182915819|SUPERIORITY||Hazard Ratio (HR)|0.456||||0.1617|TWO_SIDED|95.0|0.147|1.409|||Log Rank||Hazard Ratio (HR) along with its 2-sided 95% confidence interval (CI) were estimated using the Cox proportional hazards regression model.|||1.409|0.147|0.1617
91520580|NCT04958785|182915821|SUPERIORITY||Odds Ratio (OR)|2.037|||||TWO_SIDED|95.0|0.379|10.938|||||Odds ratios and corresponding 95% CIs were estimated using chi-square test.|||10.938|0.379|
91520581|NCT01224925|182915834|SUPERIORITY||Log Rank (Mantel-Cox)|842.0|||<|0.01|TWO_SIDED|95.0|693.0|991.0|||Log Rank|||The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.||991|693|<0.01
91520582|NCT01224925|182915834|SUPERIORITY||Log Rank (Mantel-Cox)|1201.0|||<|0.01|TWO_SIDED|95.0|1068.0|1335.0|||Log Rank|||||1335|1068|<0.01
91520583|NCT01224925|182915835|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
91520584|NCT04149925|182915837|SUPERIORITY|||||||0.01||||||Significant when p\<0.05|t-test, 2 sided|||||||0.01
91520585|NCT02472652|182915844|OTHER||change in prolactin|30.0|||||TWO_SIDED|||||||||||||
91520586|NCT03675451|182915851|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|0.95|||||TWO_SIDED|95.0|0.74|0.99|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||0.99|0.74|
91520587|NCT03675451|182915852|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|1.0|||||TWO_SIDED|95.0|0.66|1.0|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||1.00|0.66|
91520588|NCT05131165|182915993|SUPERIORITY|||||||0.056||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.056
91520589|NCT05131165|182915993|SUPERIORITY|||||||0.062||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.062
91520590|NCT05131165|182915994|SUPERIORITY|||||||0.364||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.364
91520591|NCT05131165|182915994|SUPERIORITY|||||||0.409||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.409
91520592|NCT05131165|182915995|SUPERIORITY|||||||0.158||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.158
91520593|NCT05131165|182915995|SUPERIORITY|||||||0.017||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.017
91520594|NCT05131165|182915996|SUPERIORITY|||||||0.654||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.654
91520595|NCT05131165|182915996|SUPERIORITY|||||||0.035||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.035
91520596|NCT05131165|182915998|SUPERIORITY|||||||0.5468|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5468
91581686|NCT00706433|183053323|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6907
91776114|NCT02977403|183432921|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.011|||||TWO_SIDED|95.0|-0.069|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.069|
91776115|NCT02977403|183432921|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.167|||||TWO_SIDED|95.0|-0.332|-0.002||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.002|-0.332|
91776116|NCT02977403|183432922|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.054|||||TWO_SIDED|95.0|-0.037|0.146||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.146|-0.037|
91776117|NCT02977403|183432922|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.019|||||TWO_SIDED|95.0|-0.127|0.09||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.090|-0.127|
91776118|NCT02977403|183432923|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.061|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.061|
91776119|NCT02977403|183432923|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.086|||||TWO_SIDED|95.0|-0.215|0.042||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.042|-0.215|
91790178|NCT02660138|183459522|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|13.3||||0.0003|TWO_SIDED|95.0|6.22|20.37|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||20.37|6.22|0.0003
91790179|NCT02660138|183459522|SUPERIORITY|The secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|17.25|||<|0.0001|TWO_SIDED|95.0|10.36|24.15|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||24.15|10.36|<0.0001
91581687|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0047
91520597|NCT05131165|182915998|SUPERIORITY|||||||0.5255|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5255
91520598|NCT03387579|182916130|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.590
91520599|NCT03387579|182916130|SUPERIORITY|||||||0.224|||||||Fisher Exact|||||||0.224
91520600|NCT03387579|182916130|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91520601|NCT03387579|182916131|SUPERIORITY|||||||0.471|||||||Kruskal-Wallis|||||||0.471
91520602|NCT03387579|182916132|SUPERIORITY|||||||0.525|||||||Kruskal-Wallis|||||||0.525
91520603|NCT03387579|182916133|SUPERIORITY|||||||0.753|||||||Kruskal-Wallis|||||||0.753
91646298|NCT01236053|183184690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
91520604|NCT03387579|182916134|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
91646299|NCT01236053|183184690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
91520605|NCT03387579|182916135|SUPERIORITY|||||||0.127|||||||Fisher Exact|||||||0.127
91520606|NCT03387579|182916136|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91520607|NCT03387579|182916137|SUPERIORITY||estimate|8.553||||0.046|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 4.249|||||0.046
91581688|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.6116||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6116
91581689|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.0209||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0209
91646300|NCT01236053|183184690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
91776120|NCT02977403|183432924|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.032|||||TWO_SIDED|95.0|-0.05|0.115||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.115|-0.05|
91776121|NCT02977403|183432924|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.248|0.058||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.058|-0.248|
91776122|NCT02977403|183432925|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.075|0.042||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.042|-0.075|
91776123|NCT02977403|183432925|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.025|||||TWO_SIDED|95.0|-0.13|0.18||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.180|-0.130|
91776124|NCT02977403|183432926|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.03|||||TWO_SIDED|95.0|-0.039|0.099||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).||||Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.099|-0.039|
91776125|NCT02977403|183432926|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.335|0.049||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.049|-0.335|
91776126|NCT02977403|183432927|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.097|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.097|
91776127|NCT02977403|183432927|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.162|||||TWO_SIDED|95.0|-0.314|-0.01||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.01|-0.314|
91646301|NCT01236053|183184691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
91646302|NCT01236053|183184691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
91776128|NCT02977403|183432928|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.053|||||TWO_SIDED|95.0|-0.051|0.156||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.156|-0.051|
91776129|NCT02977403|183432928|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.251|0.111||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.111|-0.251|
91776130|NCT02977403|183432929|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.015|||||TWO_SIDED|95.0|-0.061|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.061|
91776131|NCT02977403|183432929|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.108|||||TWO_SIDED|95.0|-0.26|0.044||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.044|-0.260|
91776132|NCT02977403|183432930|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.036|||||TWO_SIDED|95.0|-0.047|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.047|
91776133|NCT02977403|183432930|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.276|0.064||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.064|-0.276|
91776134|NCT02977403|183432931|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.017|||||TWO_SIDED|95.0|-0.092|0.057||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.057|-0.092|
91776135|NCT02977403|183432931|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.15|0.153||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.153|-0.150|
91646303|NCT01236053|183184691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
91776136|NCT02977403|183432932|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.07|||||TWO_SIDED|95.0|-0.019|0.159||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.159|-0.019|
91776137|NCT02977403|183432932|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.26|0.07||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.070|-0.260|
91776138|NCT02977403|183432933|SUPERIORITY||beta coefficient|-0.8707|STANDARD_ERROR_OF_MEAN|0.766||0.256|TWO_SIDED||||||Generalized estimation equations||Reported variable is a condition by time (pre or post-intervention) interaction term. The model included a Poisson distribution, log link function, exchangeable covariance matrix and was adjusted for age, fat mass, height, and race and ethnicity.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||||0.256
91776139|NCT04966013|183432946|SUPERIORITY||Hazard Ratio (HR)|1.005||||0.9784|TWO_SIDED|95.0|0.717|1.408|||Regression, Cox|||Log Rank Test and Cox PH Regression analyses were performed unstratified||1.408|0.717|0.9784
91776140|NCT04966013|183432947|SUPERIORITY||Hazard Ratio (HR)|1.388||||0.1512|TWO_SIDED|95.0|0.887|2.172||Log Rank Test and Cox PH Regression analyses were performed unstratified|Regression, Cox|||||2.172|0.887|0.1512
91776141|NCT00781768|183433004|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED||||||Chi-squared|||The null hypothesis is that there will be a higher proportion of complete responders among those subjects receiving the combination therapy.||||<.001
91776142|NCT02458313|183433012|SUPERIORITY|DMXB-A vs. Placebo groups compared at baseline||||||0.647|||||||t-test, 2 sided|||||||0.647
91776143|NCT02458313|183433012|SUPERIORITY|||||||0.679|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.679
91776144|NCT02458313|183433013|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared at baseline||||0.951
91776145|NCT02458313|183433013|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.884
91776146|NCT01428258|183433057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-147.0|STANDARD_ERROR_OF_MEAN|39.0||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
91776147|NCT01428258|183433057|OTHER|||||||0.136|||||||ANCOVA|||||||0.136
91520608|NCT03387579|182916137|SUPERIORITY||estimate|7.023||||0.04|TWO_SIDED|||||Intralipid 20% historic versus smoflipid|Mixed Models Analysis||standard error 3.376|||||0.040
91646304|NCT01236053|183184691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
91646305|NCT01236053|183184693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
91776148|NCT01428258|183433057|OTHER|||||||0.044|||||||ANCOVA|||||||0.044
91776149|NCT01428258|183433058|OTHER|||||||0.576|||||||ANOVA|||||||0.576
91646306|NCT01236053|183184693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
91776150|NCT01428258|183433059|OTHER|||||||0.902|||||||t-test, 2 sided|||||||0.902
91776151|NCT01428258|183433060|OTHER|||||||0.797|||||||t-test, 2 sided|||||||0.797
91776152|NCT01428258|183433061|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
91776153|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0187|=|0.02|TWO_SIDED|90.0|0.008|0.069|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour||0.069|0.008|=0.020
91776154|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|90.0|0.101|0.176|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.176|0.101|<0.001
91776155|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|90.0|0.087|0.158|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.158|0.087|<0.001
91776156|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0185|=|0.22|TWO_SIDED|90.0|-0.016|0.045|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.045|-0.016|=0.220
91776157|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|90.0|0.087|0.161|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.161|0.087|<0.001
91776158|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.0214|<|0.001|TWO_SIDED|90.0|0.105|0.176|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.176|0.105|<0.001
91776159|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.0188||0.155|TWO_SIDED|90.0|-0.012|0.05|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.050|-0.012|0.155
91776160|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|90.0|0.053|0.129|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour||0.129|0.053|<0.001
91776161|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|90.0|0.09|0.162|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.162|0.090|<0.001
91776162|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.188|TWO_SIDED|90.0|-0.015|0.048|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.048|-0.015|0.188
91776163|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.023|=|0.009|TWO_SIDED|90.0|0.017|0.093|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.093|0.017|=0.009
91776164|NCT00674817|183433097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|90.0|0.086|0.159|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.159|0.086|<0.001
91776165|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.0616|=|0.856|TWO_SIDED|90.0|-0.168|0.036|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour||0.036|-0.168|=0.856
91776166|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.0496|=|0.033|TWO_SIDED|90.0|0.01|0.174|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.174|0.010|=0.033
91776167|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.0523|=|0.099|TWO_SIDED|90.0|-0.019|0.154|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.154|-0.019|=0.099
91776168|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.067|STANDARD_ERROR_OF_MEAN|0.0612|=|0.862|TWO_SIDED|90.0|-0.168|0.034|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.034|-0.168|=0.862
91776169|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.0493|=|0.008|TWO_SIDED|90.0|0.039|0.201|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.201|0.039|=0.008
91776170|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0516||0.027|TWO_SIDED|90.0|0.015|0.185|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.185|0.015|0.027
91776171|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.0621|=|0.2|TWO_SIDED|90.0|-0.05|0.155|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.155|-0.050|=0.200
91776172|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.05|=|0.031|TWO_SIDED|90.0|0.011|0.177|||Mix model|||GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour||0.177|0.011|=0.031
91776173|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.053|=|0.043|TWO_SIDED|90.0|0.004|0.179|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.179|0.004|=0.043
91776174|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.0625|=|0.637|TWO_SIDED|90.0|-0.125|0.081|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.081|-0.125|=0.637
91776175|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.05|=|0.004|TWO_SIDED|90.0|0.053|0.218|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.218|0.053|=0.004
91776176|NCT00674817|183433098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0534|=|0.031|TWO_SIDED|90.0|0.012|0.189|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.189|0.012|=0.031
91520609|NCT03387579|182916137|SUPERIORITY||estimate|-1.53||||0.718|TWO_SIDED|||||Intralipid 20% Historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.231|||||0.718
91776177|NCT00674817|183433104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.747|STANDARD_ERROR_OF_MEAN|2.1768|||TWO_SIDED|95.0|-0.547|8.041||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||8.041|-0.547|
91776178|NCT00674817|183433104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.712|STANDARD_ERROR_OF_MEAN|2.1453|||TWO_SIDED|95.0|-2.521|5.944||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours||5.944|-2.521|
91776179|NCT00674817|183433104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.755|STANDARD_ERROR_OF_MEAN|2.1869|||TWO_SIDED|95.0|-2.559|6.069||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours||6.069|-2.559|
91776180|NCT00674817|183433104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.231|STANDARD_ERROR_OF_MEAN|2.197|||TWO_SIDED|95.0|-5.565|3.103||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||3.103|-5.565|
91776181|NCT00674817|183433105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.558|STANDARD_ERROR_OF_MEAN|2.7064|||TWO_SIDED|95.0|-0.781|9.897||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours||9.897|-0.781|
91776182|NCT00674817|183433105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.266|STANDARD_ERROR_OF_MEAN|2.6691|||TWO_SIDED|95.0|-2.999|7.532||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours||7.532|-2.999|
91776183|NCT00674817|183433105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.717|||TWO_SIDED|95.0|-4.429|6.29||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours||6.290|-4.429|
91520610|NCT03387579|182916138|SUPERIORITY||estimate|13.436||||0.003|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 4.440|||||0.003
91520611|NCT03387579|182916138|SUPERIORITY||estimate|3.936||||0.27|TWO_SIDED|||||Intralipid 20% historic versus Smoflipid 20%|Mixed Models Analysis||standard error 3.553|||||0.270
91520612|NCT03387579|182916138|SUPERIORITY||estimate|-9.5||||0.034|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.416|||||0.034
91520613|NCT03387579|182916139|SUPERIORITY||estimate|42.674||||0.006|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 15.216|||||0.006
91520614|NCT03387579|182916139|SUPERIORITY||estimate|11.117||||0.305|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.771|||||0.305
91581690|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.0513||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0513
91581691|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0019
91581692|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.0089||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0089
91776184|NCT00674817|183433105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.152|STANDARD_ERROR_OF_MEAN|2.731|||TWO_SIDED|95.0|-6.539|4.236||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours||4.236|-6.539|
91776185|NCT00674817|183433106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.249|STANDARD_ERROR_OF_MEAN|1.6816|||TWO_SIDED|95.0|-2.069|4.566||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||4.566|-2.069|
91776186|NCT00674817|183433106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.418|STANDARD_ERROR_OF_MEAN|1.6565|||TWO_SIDED|95.0|-2.85|3.687||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||3.687|-2.850|
91776187|NCT00674817|183433106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-4.013|2.714||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||2.714|-4.013|
91776188|NCT00674817|183433106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.949|STANDARD_ERROR_OF_MEAN|1.7112|||TWO_SIDED|95.0|-5.325|1.427||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||1.427|-5.325|
91776189|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.198|STANDARD_ERROR_OF_MEAN|2.5039|||TWO_SIDED|95.0|5.258|15.139||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||15.139|5.258|
91776190|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.686|STANDARD_ERROR_OF_MEAN|2.4738|||TWO_SIDED|95.0|-2.195|7.567||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||7.567|-2.195|
91776191|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.854|STANDARD_ERROR_OF_MEAN|2.5196|||TWO_SIDED|95.0|2.883|12.825||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||12.825|2.883|
91776192|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|2.5244|||TWO_SIDED|95.0|-5.864|4.097||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||4.097|-5.864|
91776193|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.227|STANDARD_ERROR_OF_MEAN|2.9782|||TWO_SIDED|95.0|5.352|17.103||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||17.103|5.352|
91646307|NCT01236053|183184693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
91776194|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|2.9434|||TWO_SIDED|95.0|-1.418|10.197||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||10.197|-1.418|
91776195|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.975|STANDARD_ERROR_OF_MEAN|2.9958|||TWO_SIDED|95.0|0.065|11.886||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||11.886|0.065|
91776196|NCT00674817|183433107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.083|STANDARD_ERROR_OF_MEAN|3.0023|||TWO_SIDED|95.0|-8.006|3.84||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||3.840|-8.006|
91776197|NCT00674817|183433108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|1.6941|||TWO_SIDED|95.0|1.857|8.542||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||8.542|1.857|
91581693|NCT00706433|183053324|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5260
91581694|NCT00706433|183053325|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7820
91581695|NCT00706433|183053326|SUPERIORITY_OR_OTHER|||||||0.4965||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4965
91581696|NCT00706433|183053327|SUPERIORITY_OR_OTHER|||||||0.0728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0728
91776198|NCT00674817|183433108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|1.6727|||TWO_SIDED|95.0|-3.294|3.307||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.307|-3.294|
91776199|NCT00674817|183433108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|1.7178|||TWO_SIDED|95.0|-0.433|6.345||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||6.345|-0.433|
91776200|NCT00674817|183433108|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.683|STANDARD_ERROR_OF_MEAN|1.7199|||TWO_SIDED|95.0|-5.076|1.711||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.711|-5.076|
91776201|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.588|STANDARD_ERROR_OF_MEAN|1.3932|||TWO_SIDED|95.0|3.839|9.336||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||9.336|3.839|
91776202|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.255|STANDARD_ERROR_OF_MEAN|1.3725|||TWO_SIDED|95.0|-1.453|3.962||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.962|-1.453|
91776203|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.985|STANDARD_ERROR_OF_MEAN|1.396|||TWO_SIDED|95.0|4.231|9.738||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||9.738|4.231|
91708153|NCT01134263|183309187|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.076|||||TWO_SIDED|95.0|-0.173|0.021||||||Dengue Virus Serotype 3||0.021|-0.173|
91520615|NCT03387579|182916139|SUPERIORITY||estimate|-31.557|||<|0.001|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 67.673|||||<0.001
91520616|NCT03387579|182916140|SUPERIORITY||estimate|-0.593||||0.835|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 2.848|||||0.835
91520617|NCT03387579|182916140|SUPERIORITY||estimate|-0.522||||0.799|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 2.050|||||0.799
91708154|NCT01134263|183309187|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.017|||||TWO_SIDED|95.0|-0.137|0.103||||||Dengue Virus Serotype 4||0.103|-0.137|
91708155|NCT02259699|183309209|SUPERIORITY|||||||0.582|||||||t-test, 2 sided|||Difference between arms at T1||||0.582
91520618|NCT03387579|182916140|SUPERIORITY||estimate|0.714||||0.714|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 2.758|||||0.714
91520619|NCT03387579|182916141|SUPERIORITY||estimate|11.162||||0.379|TWO_SIDED||||||Mixed Models Analysis|Intralipid 20% reduction versus smoflipid 20%|standard error 12.626|||||0.379
91646308|NCT01236053|183184693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.5|0.1118
91708156|NCT02259699|183309209|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||Difference between arms at T3||||0.053
91646309|NCT01236053|183184694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9614|TWO_SIDED|95.0|0.58|1.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.58|0.9614
91708157|NCT02259699|183309209|SUPERIORITY|||||||0.288|||||||t-test, 2 sided|||Difference between arms at T4||||0.288
91708158|NCT02259699|183309210|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||Difference between arms at T3||||0.087
91776204|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.255|STANDARD_ERROR_OF_MEAN|1.4077|||TWO_SIDED|95.0|-0.522|5.031||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.031|-0.522|
91520620|NCT03387579|182916141|SUPERIORITY||estimate|3.853||||0.717|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.615|||||0.717
91520621|NCT03387579|182916141|SUPERIORITY|Intralipid 20% historic versus intralipid 20% reduction|estimate|-7.31||||0.576|TWO_SIDED||||||Mixed Models Analysis||standard error 13.025|||||0.576
91520622|NCT03387579|182916142|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
91520623|NCT03387579|182916142|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
91520624|NCT03387579|182916143|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91520625|NCT03387579|182916143|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.640
91520626|NCT03387579|182916143|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91520627|NCT03387579|182916144|SUPERIORITY|||||||0.211|||||||Kruskal-Wallis|||||||0.211
91520628|NCT03387579|182916145|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
91520629|NCT03387579|182916146|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
91520630|NCT03387579|182916147|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|||||||0.774
91520631|NCT03387579|182916148|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
91520632|NCT03387579|182916149|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
91520633|NCT01804816|182916175|EQUIVALENCE|a=0.05||||||0.063|||||||t-test, 2 sided|||||||0.063
91520634|NCT01804816|182916176|EQUIVALENCE|a = 0.05||||||0.005|||||||t-test, 2 sided|||Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.||||0.005
91520635|NCT01804816|182916176|EQUIVALENCE|a=0.05||||||0.002|||||||t-test, 2 sided|||||||0.002
91520636|NCT01804816|182916176|EQUIVALENCE|a=0.05||||||0.441|||||||t-test, 2 sided|||||||0.441
91520637|NCT01804816|182916177|EQUIVALENCE|a=0.05||||||0.729|||||||t-test, 2 sided|||||||0.729
91520638|NCT01123382|182916187|SUPERIORITY_OR_OTHER|||||||0.04||||||Group X time interaction|Mixed Models Analysis|we included a random intercept for each individual participant. We used a first-order antedependent covariance structure.||To detect a minimum clinically important difference of 2 points2 on the BPI-SF3 with an anticipated standard deviation for each mean of 2.5, estimated from a prior study, with an alpha level of 0.05 and a power of 80%, for five waves of data, a sample size of 10 participants per group was necessary. With anticipated dropouts, a sample size of at least 12 participants per group was required.||||0.04
91520639|NCT01123382|182916188|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||group x time interaction 0.059|Mixed Models Analysis|||||||0.059
91520640|NCT01123382|182916189|SUPERIORITY_OR_OTHER|||||||0.543||||||group x time interaction 0.543|Mixed Models Analysis|||||||0.543
91520641|NCT01123382|182916190|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||group x time interaction 0.33|Mixed Models Analysis|||||||0.33
91520642|NCT01123382|182916191|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||group x time 0.61|Mixed Models Analysis|||||||0.61
91520643|NCT01123382|182916192|SUPERIORITY_OR_OTHER|||||||0.398||||||group x time interaction 0.398|Mixed Models Analysis|||||||0.398
91520644|NCT01123382|182916193|SUPERIORITY_OR_OTHER|||||||0.46||||||group x time interaction 0.46|Mixed Models Analysis|||||||0.46
91520645|NCT01123382|182916194|SUPERIORITY_OR_OTHER|||||||0.59||||||group x time interaction 0.59|Mixed Models Analysis|||||||0.59
91520646|NCT01123382|182916195|SUPERIORITY_OR_OTHER|||||||0.69||||||group x time interaction 0.69|Mixed Models Analysis|||||||0.69
91520647|NCT00834106|182916198|SUPERIORITY_OR_OTHER||Vaccine efficacy|76.0|||||TWO_SIDED|95.0|43.7|91.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||91.1|43.7|
91520648|NCT00834106|182916199|SUPERIORITY_OR_OTHER||Vaccine efficacy|82.3|||||TWO_SIDED|95.0|38.3|96.7|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||96.7|38.3|
91520649|NCT00834106|182916200|SUPERIORITY_OR_OTHER||Vaccine efficacy|100.0||||0.0072|TWO_SIDED|95.0|32.3|100.0|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||100|32.3|0.0072
91520650|NCT00834106|182916206|SUPERIORITY_OR_OTHER||Vaccine efficacy|91.8|||||TWO_SIDED|95.0|79.8|97.4|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||97.4|79.8|
91520651|NCT00834106|182916207|SUPERIORITY_OR_OTHER||Vaccine efficacy|93.2|||||TWO_SIDED|95.0|72.9|99.2|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||99.2|72.9|
91520652|NCT01755702|182916233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.284|TWO_SIDED|95.0|0.83|1.9|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.90|0.83|0.2840
91520653|NCT01755702|182916233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.2008|TWO_SIDED|95.0|0.86|2.01|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||2.01|0.86|0.2008
91520654|NCT01755702|182916233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4552|TWO_SIDED|95.0|0.78|1.74|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.74|0.78|0.4552
91520655|NCT01755702|182916233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.5579|TWO_SIDED|95.0|0.75|1.71|||Cox Proportional Hazard Model|||||1.71|0.75|0.5579
91520656|NCT01755702|182916233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.7214|TWO_SIDED|95.0|0.72|1.61|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.61|0.72|0.7214
91520657|NCT01755702|182916233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.8192|TWO_SIDED|95.0|0.62|1.45|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.45|0.62|0.8192
91520658|NCT03882879|182916247|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
91520659|NCT03882879|182916248|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
91776205|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.121|STANDARD_ERROR_OF_MEAN|1.2464|||TWO_SIDED|95.0|1.662|6.58||||||GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours||6.580|1.662|
91776206|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|1.2278|||TWO_SIDED|95.0|-2.142|2.703||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.703|-2.142|
91776207|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.266|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|1.802|6.729||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||6.729|1.802|
91776208|NCT00674817|183433109|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.621|STANDARD_ERROR_OF_MEAN|1.2593|||TWO_SIDED|95.0|-0.863|4.106||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||4.106|-0.863|
91776209|NCT00674817|183433110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.094|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|2.456|5.732||||||GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||5.732|2.456|
91776210|NCT00674817|183433110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.646|STANDARD_ERROR_OF_MEAN|0.8172|||TWO_SIDED|95.0|-0.967|2.258||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||2.258|-0.967|
91776211|NCT00674817|183433110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.98|STANDARD_ERROR_OF_MEAN|0.8395|||TWO_SIDED|95.0|2.324|5.636||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.636|2.324|
91776212|NCT00674817|183433110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.934|STANDARD_ERROR_OF_MEAN|0.846|||TWO_SIDED|95.0|-0.735|2.603||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||2.603|-0.735|
91776213|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|1.8168|||TWO_SIDED|95.0|-5.42|1.748||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.748|-5.420|
91776214|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|1.7809|||TWO_SIDED|95.0|-2.914|4.113||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.113|-2.914|
91776215|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|1.8174|||TWO_SIDED|95.0|-3.261|3.909||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||3.909|-3.261|
91776216|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.182|STANDARD_ERROR_OF_MEAN|1.8242|||TWO_SIDED|95.0|-5.781|1.416||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.416|-5.781|
91776217|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.266|STANDARD_ERROR_OF_MEAN|1.7723|||TWO_SIDED|95.0|-6.762|0.23||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.230|-6.762|
91776218|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.7361|||TWO_SIDED|95.0|-3.502|3.348||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||3.348|-3.502|
91776219|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.827|STANDARD_ERROR_OF_MEAN|1.7743|||TWO_SIDED|95.0|-1.673|5.327||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||5.327|-1.673|
91776220|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.232|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-4.743|2.279||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.279|-4.743|
91776221|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.394|STANDARD_ERROR_OF_MEAN|1.3084|||TWO_SIDED|95.0|-3.976|1.187||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||1.187|-3.976|
91776222|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.181|STANDARD_ERROR_OF_MEAN|1.2819|||TWO_SIDED|95.0|-1.348|3.71||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||3.710|-1.348|
91776223|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|1.3201|||TWO_SIDED|95.0|-2.498|2.71||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||2.710|-2.498|
91776224|NCT00674817|183433111|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.713|STANDARD_ERROR_OF_MEAN|1.3241|||TWO_SIDED|95.0|-3.325|1.899||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.899|-3.325|
91776225|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.561|STANDARD_ERROR_OF_MEAN|1.2351|||TWO_SIDED|95.0|-2.997|1.876||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.876|-2.997|
91776226|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.705|STANDARD_ERROR_OF_MEAN|1.2125|||TWO_SIDED|95.0|-0.687|4.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.097|-0.687|
91776227|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.337|STANDARD_ERROR_OF_MEAN|1.2341|||TWO_SIDED|95.0|-3.771|1.098||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.098|-3.771|
91776228|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.067|STANDARD_ERROR_OF_MEAN|1.2416|||TWO_SIDED|95.0|-3.516|1.382||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.382|-3.516|
91776229|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.376|STANDARD_ERROR_OF_MEAN|1.0997|||TWO_SIDED|95.0|-2.545|1.794||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.794|-2.545|
91776230|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.0786|||TWO_SIDED|95.0|-1.588|2.668||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.668|-1.588|
91776231|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|1.0999|||TWO_SIDED|95.0|-2.185|2.154||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.154|-2.185|
91776232|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.1058|||TWO_SIDED|95.0|-1.715|2.648||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.648|-1.715|
91776233|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.881|||TWO_SIDED|95.0|-2.918|0.559||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.559|-2.918|
91646310|NCT01236053|183184694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5179|TWO_SIDED|95.0|0.49|1.44|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.44|0.49|0.5179
91776234|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.876|STANDARD_ERROR_OF_MEAN|0.8644|||TWO_SIDED|95.0|-0.829|2.582||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||2.582|-0.829|
91776235|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.8882|||TWO_SIDED|95.0|-2.561|0.944||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.944|-2.561|
91776236|NCT00674817|183433112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.8929|||TWO_SIDED|95.0|-2.122|1.401||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.401|-2.122|
91776237|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.2352|||TWO_SIDED|95.0|0.066|0.994||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.994|0.066|
91776238|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.388|STANDARD_ERROR_OF_MEAN|0.2318|||TWO_SIDED|95.0|-0.069|0.846||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.846|-0.069|
91776239|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2363|||TWO_SIDED|95.0|-0.157|0.775||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.775|-0.157|
91776240|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2392|||TWO_SIDED|95.0|-0.163|0.78||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.780|-0.163|
91776241|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.3099|||TWO_SIDED|95.0|0.262|1.485||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.485|0.262|
91776242|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.3056|||TWO_SIDED|95.0|-0.656|0.55||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.550|-0.656|
91776243|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.829|STANDARD_ERROR_OF_MEAN|0.3112|||TWO_SIDED|95.0|0.215|1.443||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.443|0.215|
91776244|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.567|STANDARD_ERROR_OF_MEAN|0.3151|||TWO_SIDED|95.0|-0.054|1.189||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.189|-0.054|
91520660|NCT03882879|182916249|SUPERIORITY|||||||0.76||||||Between-group two-sided t-test|t-test, 2 sided|||||||0.76
91520661|NCT03882879|182916250|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
91520662|NCT03882879|182916251|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
91646311|NCT01236053|183184694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8856|TWO_SIDED|95.0|0.71|1.48|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.48|0.71|0.8856
91646312|NCT01236053|183184694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5078|TWO_SIDED|95.0|0.61|1.28|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.28|0.61|0.5078
91776245|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.1021|||TWO_SIDED|95.0|0.11|0.513||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.513|0.110|
91776246|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.1006|||TWO_SIDED|95.0|-0.025|0.372||||||GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.372|-0.025|
91776247|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1035|||TWO_SIDED|95.0|0.006|0.414||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.414|0.006|
91776248|NCT00674817|183433113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|-0.103|0.311||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.311|-0.103|
91776249|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|95.0|-0.276|-0.078||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||-0.078|-0.276|
91776250|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|-0.096|0.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.097|-0.096|
91776251|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.174|0.022||||||SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.022|-0.174|
91776252|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0507|||TWO_SIDED|95.0|-0.128|0.072||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.072|-0.128|
91776253|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.166|STANDARD_ERROR_OF_MEAN|0.0493|||TWO_SIDED|95.0|-0.263|-0.069||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||-0.069|-0.263|
91776254|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.0481|||TWO_SIDED|95.0|-0.152|0.038||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.038|-0.152|
91581697|NCT00706433|183053328|SUPERIORITY_OR_OTHER|||||||0.548||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5480
91581698|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.0301||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0301
91646313|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6888|TWO_SIDED|95.0|0.36|1.95|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.95|0.36|0.6888
91646314|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5024|TWO_SIDED|95.0|0.32|1.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.75|0.32|0.5024
91520663|NCT04496219|182916258|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||This p value relates to instillation adherence||||0.97
91520664|NCT04496219|182916258|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||This p value relates to missed visits.||||0.17
91520665|NCT04496219|182916259|SUPERIORITY|||||||0.5638|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.||||0.5638
91520666|NCT04496219|182916259|SUPERIORITY|||||||0.1753|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.||||0.1753
91520667|NCT04496219|182916259|SUPERIORITY|||||||0.2062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.||||0.2062
91520668|NCT04496219|182916260|SUPERIORITY|||||||0.8092|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.||||0.8092
91520669|NCT04496219|182916260|SUPERIORITY|||||||0.5492|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.||||0.5492
91520670|NCT04496219|182916260|SUPERIORITY|||||||0.6464|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.||||0.6464
91520671|NCT04496219|182916260|SUPERIORITY|||||||0.586|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.||||0.586
91520672|NCT04496219|182916260|SUPERIORITY|||||||0.8999|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.||||0.8999
91520673|NCT04496219|182916260|SUPERIORITY|||||||0.2007|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.||||0.2007
91520674|NCT04496219|182916260|SUPERIORITY|||||||0.9921|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.||||0.9921
91520675|NCT04496219|182916260|SUPERIORITY|||||||0.5723|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.||||0.5723
91520676|NCT04496219|182916260|SUPERIORITY|||||||0.812|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.||||0.812
91520677|NCT04496219|182916260|SUPERIORITY|||||||0.96|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.||||0.96
91520678|NCT04496219|182916260|SUPERIORITY|||||||0.1062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.||||0.1062
91520679|NCT04496219|182916260|SUPERIORITY|||||||0.3259|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.||||0.3259
91520680|NCT04496219|182916260|SUPERIORITY|||||||0.9664|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.||||0.9664
91520681|NCT04496219|182916260|SUPERIORITY|||||||0.4564|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.||||0.4564
91520682|NCT04496219|182916260|SUPERIORITY|||||||0.1036|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.||||0.1036
91520683|NCT04496219|182916260|SUPERIORITY|||||||0.1789|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.||||0.1789
91520684|NCT04496219|182916260|SUPERIORITY|||||||0.5186|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.||||0.5186
91520685|NCT04496219|182916260|SUPERIORITY|||||||0.0757|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.||||0.0757
91520686|NCT04496219|182916260|SUPERIORITY|||||||0.1174|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.||||0.1174
91520687|NCT04496219|182916260|SUPERIORITY|||||||0.3129|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.||||0.3129
91520688|NCT00416182|182916264|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant|t-test, 2 sided|||||||0.2
91520689|NCT00416182|182916265|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant.|t-test, 2 sided|||||||0.048
91520690|NCT00416182|182916266|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||P-value \< 0.05 is considered significant|t-test, 2 sided|||||||0.003
91520691|NCT00416182|182916267|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P \<0.05 is considered significant|t-test, 2 sided|||||||0.4
91776255|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.0489|||TWO_SIDED|95.0|-0.267|-0.075||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||-0.075|-0.267|
91520692|NCT04102579|182916286|OTHER||Least Squares (LS) Means Difference|-3.16|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-4.37|-1.95||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|Results were analyzed using a mixed-effect model repeated measures (MMRM) analysis. The model included the screening period baseline TMC as a covariate, and treatment group, visit, treatment group-by-visit interaction, and baseline-by-visit interaction as fixed effects. Participant was included as a random effect.||-1.95|-4.37|<0.0001
91520693|NCT04102579|182916287|OTHER||Percent Difference in Responders|29.65||||0.0007|TWO_SIDED|95.0|10.77|45.37||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||45.37|10.77|0.0007
91520694|NCT04102579|182916288|OTHER||Percent Difference in Responders|26.31||||0.0062|TWO_SIDED|95.0|6.32|43.74||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||43.74|6.32|0.0062
91520695|NCT04102579|182916289|OTHER||LS Means Difference|1.42|STANDARD_ERROR_OF_MEAN|1.46||0.3304|TWO_SIDED|95.0|-1.46|4.31||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|LS mean was based on the MMRM model which included corresponding baseline value of the Neuro-QoL Upper Extremity Function T-score as a covariate; treatment group, visit, baseline-by-visit interaction, and treatment group-by-visit interaction as fixed effects; and participant as a random effect.||4.31|-1.46|0.3304
91520696|NCT05899686|182916291|EQUIVALENCE|Equivalence was defined as ANOVA p\<0.05||||||0.65|||||||ANOVA|||Maximum percent change from baseline (light transmittance) during 60 heart beats after the tetanic stimulus were compared between the three stimulus locations using ANOVA||||0.65
91520697|NCT00572195|182916292|OTHER||Wilson score interval|77.0|||||TWO_SIDED|95.0|71.1|81.9|||||The value is for all serious adverse events, regardless of device relation.||95% confidence interval estimated using the Wilson score interval|81.9|71.1|
91520698|NCT00572195|182916293|OTHER||||||<|0.05||||||For all 6-month periods, from 6 months through 9 years post-implant, p \<0.05.|Wilcoxon Signed Rank Test|||||||<0.05
91520699|NCT00572195|182916295|OTHER||GEE estimated intercept|48.0|||<|0.0001|TWO_SIDED|95.0|46.8|49.2|||Generalized estimating equation (GEE)|||||49.2|46.8|<0.0001
91520700|NCT00572195|182916295|OTHER||Slope|0.0||||0.6729|TWO_SIDED|95.0|-0.2|0.1|||Generalized estimating equation (GEE)|||||0.1|-0.2|0.6729
91520701|NCT00949884|182916315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.8|-1.3|||ANCOVA|The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.||Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.||-1.3|-3.8|<0.0001
91520702|NCT00949884|182916316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-5.3|-1.8|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.8|-5.3|<0.0001
91520703|NCT00949884|182916317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.99||0.0001|TWO_SIDED|95.0|-5.8|-1.9|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.9|-5.8|0.0001
91520704|NCT00949884|182916318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-3.8|-1.5|||ANCOVA|ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.||||-1.5|-3.8|<0.0001
91520705|NCT00949884|182916320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.55||0.1121|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.2|-2.0|0.1121
91646315|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6164|TWO_SIDED|95.0|0.49|1.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.53|0.49|0.6164
91776256|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.108|0.089||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||0.089|-0.108|
91520706|NCT00949884|182916320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0783|TWO_SIDED|95.0|-2.0|0.1|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.1|-2.0|0.0783
91520707|NCT00949884|182916321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.2312|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.7|-2.9|0.2312
91520708|NCT00949884|182916321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.0979|TWO_SIDED|95.0|-3.2|0.3|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.3|-3.2|0.0979
91520709|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
91520710|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||0.0001
91520711|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
91520712|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
91581699|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.0564||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0564
91646316|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4002|TWO_SIDED|95.0|0.44|1.39|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.39|0.44|0.4002
91776257|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.0522|||TWO_SIDED|95.0|-0.211|-0.005||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||-0.005|-0.211|
91520713|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
91520714|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
91520715|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.2755||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.2755
91520716|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.1646||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.1646
91520717|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
91520718|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
91520719|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.|Regression, Logistic|||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
91520720|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
91520721|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0010
91520722|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0011
91520723|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
91520724|NCT00949884|182916322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
91646317|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7329|TWO_SIDED|95.0|0.25|2.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.66|0.25|0.7329
91708159|NCT02259699|183309210|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Difference between arms at T4||||0.910
91708160|NCT02259699|183309211|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
91776258|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0509|||TWO_SIDED|95.0|-0.087|0.114||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.114|-0.087|
91776259|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.18|0.026||||||GSK961081 1200 mcg Plus SAL GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.026|-0.180|
91776260|NCT00674817|183433114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.0529|||TWO_SIDED|95.0|-0.129|0.08||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.080|-0.129|
91776261|NCT00834977|183433122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.08||||||90.0|97.23|105.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.09|97.23|
91776262|NCT00834977|183433123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.38||||||90.0|96.63|102.22|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.22|96.63|
91776263|NCT00834977|183433124|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.48||||||90.0|95.8|101.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.23|95.80|
91776264|NCT00834977|183433125|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.72||||||90.0|86.95|112.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.09|86.95|
91776265|NCT00834977|183433126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.69||||||90.0|90.54|101.14|||||Metabolite presented for informational purposes only.|||101.14|90.54|
91776266|NCT00834977|183433127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|99.43||||||90.0|96.48|102.46|||||Metabolite presented for informational purposes only.|||102.46|96.48|
91776267|NCT00834977|183433128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|97.2||||||90.0|92.82|101.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.78|92.82|
91776268|NCT00834977|183433129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|96.99||||||90.0|92.52|101.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.68|92.52|
91776269|NCT00834977|183433130|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.24||||||90.0|96.21|102.35|||||Metabolite presented for informational purposes only.|||102.35|96.21|
91776270|NCT04723056|183433150|OTHER|||||||0.282||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.282
91776271|NCT04723056|183433151|OTHER|||||||0.217||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.217
91776272|NCT04723056|183433152|OTHER|||||||0.462||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.462
91776273|NCT04723056|183433152|OTHER|||||||0.179||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.179
91776274|NCT04723056|183433153|OTHER|||||||0.573||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.573
91776275|NCT04723056|183433153|OTHER|||||||0.606||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.606
91776276|NCT04723056|183433154|OTHER|||||||0.181||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.181
91520725|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0005
91520726|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0004
91520727|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0023
91520728|NCT00949884|182916322|SUPERIORITY_OR_OTHER|||||||0.0012||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0012
91776277|NCT04723056|183433155|OTHER|||||||0.407||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.407
91776278|NCT04723056|183433156|OTHER|||||||0.643||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.643
91776279|NCT04723056|183433157|OTHER|||||||0.625||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.625
91776280|NCT04723056|183433157|OTHER|||||||0.707||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.707
91776281|NCT05106894|183433159|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-7.4|5.5||||||||5.5|-7.4|
91776282|NCT05106894|183433160|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-8.3|3.6||||||||3.6|-8.3|
91776283|NCT05106894|183433161|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-5.6|2.1||||||||2.1|-5.6|
91776284|NCT01968447|183433167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
91776285|NCT04196777|183433202|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 3. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.089||||0.004|TWO_SIDED|95.0|0.016|0.445|||Regression, Logistic|||To model the primary outcome for site 3, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||0.445|0.016|0.004
91581700|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4470
91520729|NCT00949884|182916323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
91520730|NCT00949884|182916323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
91520731|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0009
91520732|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0007
91520733|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0347||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0347
91520734|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0280
91708161|NCT02259699|183309212|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Difference between arms at T3||||0.071
91520735|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0519||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0519
91520736|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0605||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0605
91520737|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0001
91520738|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0003
91520739|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0070
91520740|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0066||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0066
91520741|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0061
91520742|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0096
91520743|NCT00949884|182916323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
91520744|NCT00949884|182916323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
91520745|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0047
91520746|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0063
91520747|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0589
91520748|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0594||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0594
91708162|NCT02259699|183309212|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||Difference between arms at T4||||0.332
91520749|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0476||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0476
91520750|NCT00949884|182916323|SUPERIORITY_OR_OTHER|||||||0.0657||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0657
91520751|NCT00949884|182916324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.325|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3250
91520752|NCT00949884|182916324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3491|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3491
91520753|NCT00949884|182916324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.2085|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.7|-3.2|0.2085
91520754|NCT00949884|182916324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2542|TWO_SIDED|95.0|-3.0|0.8|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.8|-3.0|0.2542
91776286|NCT04196777|183433202|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 1. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|1.593||||0.259|TWO_SIDED|95.0|0.71|3.585|||Regression, Logistic|||To model the primary outcome for site 1, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||3.585|0.710|0.259
91581701|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.2804||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2804
91581702|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.1835||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1835
91646318|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.5731|TWO_SIDED|95.0|0.22|2.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.33|0.22|0.5731
91520755|NCT00949884|182916325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0209|TWO_SIDED|95.0|-6.6|-0.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.5|-6.6|0.0209
91520756|NCT00949884|182916325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0186|TWO_SIDED|95.0|-6.6|-0.6|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.6|-6.6|0.0186
91520757|NCT00949884|182916325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0175|TWO_SIDED|95.0|-4.5|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.5|0.0175
91520758|NCT00949884|182916325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0177|TWO_SIDED|95.0|-4.4|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.4|0.0177
91520759|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3104|TWO_SIDED|95.0|-5.2|1.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.7|-5.2|0.3104
91520760|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3653|TWO_SIDED|95.0|-4.9|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.8|-4.9|0.3653
91520761|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.1197|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.5|-4.1|0.1197
91520762|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1654|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.7|-3.9|0.1654
91520763|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.4362|TWO_SIDED|95.0|-4.4|1.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.9|-4.4|0.4362
91520764|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4039|TWO_SIDED|95.0|-4.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.8|-4.5|0.4039
91520765|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.3929|TWO_SIDED|95.0|-3.1|1.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.2|-3.1|0.3929
91520766|NCT00949884|182916326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4259|TWO_SIDED|95.0|-3.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.3|-3.0|0.4259
91520767|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0396|TWO_SIDED|95.0|-6.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.2|-6.8|0.0396
91520768|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0345|TWO_SIDED|95.0|-6.8|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.3|-6.8|0.0345
91520769|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0324|TWO_SIDED|95.0|-4.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.8|0.0324
91520770|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0363|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.7|0.0363
91776287|NCT04196777|183433202|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 2. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.748||||0.738|TWO_SIDED|95.0|0.135|4.147|||Regression, Logistic|||To model the primary outcome for site 2, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||4.147|0.135|0.738
91776288|NCT04196777|183433203|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 3 between the baseline and intervention periods.|Rank sum test statistic|1280.5||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 3 were compared using the Wilcoxon rank-sum test.||||0.001
91776289|NCT04196777|183433203|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 1 between the baseline and intervention periods.|Rank sum test statistic|28662.0||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 1 were compared using the Wilcoxon rank-sum test.Type of statistical test||||0.013
91776290|NCT04196777|183433203|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 2 between the baseline and intervention periods.|Rank sum test statistic|784.0||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 2 were compared using the Wilcoxon rank-sum test.||||0.14
91776291|NCT04196777|183433204|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.76||||0.04|TWO_SIDED|95.0|0.58|0.99|||Regression, Logistic|||To model this secondary outcome, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome. This last variable was included to assess the risk of these secondary outcomes in patients who were not exposed to post-procedural antimicrobials compared to those who were exposed.||0.99|0.58|0.04
91646319|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.69|0.3762
91520771|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0988|TWO_SIDED|95.0|-6.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.6|-6.5|0.0988
91646320|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.582|TWO_SIDED|95.0|0.62|2.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.36|0.62|0.5820
91708163|NCT02259699|183309213|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||Difference between arms at T3||||0.177
91776292|NCT04196777|183433205|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.68|||<|0.01|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||To model this secondary outcome across all sites, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome.||0.87|0.53|<0.01
91776293|NCT00981656|183433209|OTHER|No testing is done, conclusions are made based on the confidence interval.||||||||||||||||Null hypothesis = this treatment will result in 75% of participants free from radical cystectomy at 3 years. A lower confidence bound of 60% will be promising enough to pursue this regimen further. A sample size of 33 analyzable patients provides a one-sided 97.5% lower bound of 60% relative to the hypothesized 75%. In terms of type I error, this design provides a 2.5% chance of observing a 3-year percentage less than 60% if the true rate is 75%.|If the lower confidence interval (CI) limit was above 60% then the regimen would be considered promising enough to warrant further study for this treatment regimen. If the lower limit was below 25% then the treatment would not be considered worthy of further study. If the lower limit fell between 25% and 60%, the investigators would consider the possibility of further investigation.|||
91776294|NCT04026113|183433221|SUPERIORITY||Difference|1.17|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|95.0|0.651|1.689||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||1.689|0.651|< 0.0001
91776295|NCT04026113|183433221|SUPERIORITY|||||||0.4323||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4323
91776296|NCT04026113|183433223|SUPERIORITY||Difference|0.423|STANDARD_ERROR_OF_MEAN|0.109||0.0001|TWO_SIDED|95.0|0.208|0.638||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||0.638|0.208|0.0001
91776297|NCT04026113|183433223|SUPERIORITY|||||||0.4381||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4381
91776298|NCT01709721|183433257|SUPERIORITY|||||||0.147|||||||Chi-squared|Pearson's chi-square test||Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.||||0.147
91708164|NCT02259699|183309213|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Difference between arms at T4||||0.745
91776299|NCT01709721|183433258|SUPERIORITY|||||||0.0342|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0342
91776300|NCT01709721|183433259|SUPERIORITY|||||||0.1642|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.1642
91776301|NCT01709721|183433260|SUPERIORITY|||||||0.016|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0160
91776302|NCT01709721|183433261|SUPERIORITY|||||||0.0007|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0007
91776303|NCT01709721|183433262|SUPERIORITY|||||||0.0088||||||ANCOVA, with randomization group as the factor and initial parameter value as covariate.|ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0088
91776304|NCT01709721|183433263|SUPERIORITY|||||||0.011||||||Log-rank test for Kaplan-Meier Estimate of Time to Rescue (days).|Log Rank|||||||0.011
91776305|NCT01709721|183433264|SUPERIORITY|||||||0.0335|||||||Cochran-Mantel-Haenszel|||P-value by the Cochran-Mantel-Haenszel mean score test (using equally spaced scores).||||0.0335
91776306|NCT01709721|183433266|SUPERIORITY|Pearson's chi-square test||||||0.01||||||Pearson's chi-square test|Chi-squared|||||||0.010
91776307|NCT03402217|183433271|SUPERIORITY|||||||0.383|||||||Wilcoxon (Mann-Whitney)|||Pre and post-score paired comparison.||||.383
91776308|NCT03402217|183433272|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Information pre-post paired comparison||||.001
91776309|NCT03402217|183433272|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Motivation pre- and post-paired comparison.||||.07
91776310|NCT03402217|183433272|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Behavior pre and post paired comparison||||.230
91776311|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.16||||0.0029|TWO_SIDED|95.0|0.06|0.26||estimates of total lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2600|0.0600|0.0029
91776312|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.1825||||0.0007|TWO_SIDED|95.0|0.0855|0.2795||estimates of left lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2795|0.0855|0.0007
91776313|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.1565||||0.0093|TWO_SIDED|95.0|0.0419|0.2711||estimates of right lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2711|0.0419|0.0093
91776314|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.1764||||0.0007|TWO_SIDED|95.0|0.0823|0.2704||estimates of left lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2704|0.0823|0.0007
91776315|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.1999||||0.001|TWO_SIDED|95.0|0.0894|0.3103||estimates of left lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3103|0.0894|0.0010
91776316|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.136||||0.0159|TWO_SIDED|95.0|0.0276|0.2443||estimates of right lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2443|0.0276|0.0159
91776317|NCT02135861|183433281|OTHER||Mean Difference (Final Values)|0.1748||||0.0064|TWO_SIDED|95.0|0.0535|0.2961||estimates of right lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2961|0.0535|0.0064
91776318|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|-0.0137||||0.7381|TWO_SIDED|95.0|-0.0968|0.0695||estimates of total lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0695|-0.0968|0.7381
91776319|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|0.0136||||0.6992|TWO_SIDED|95.0|-0.058|0.0852||estimates of left lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0852|-0.0580|0.6992
91776320|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|-0.0258||||0.5778|TWO_SIDED|95.0|-0.1201|0.0684||estimates of right lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0684|-0.1201|0.5778
91776321|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|0.0005||||0.9899|TWO_SIDED|95.0|-0.0738|0.0747||estimates of left lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0747|-0.0738|0.9899
91776322|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|0.0396||||0.2912|TWO_SIDED|95.0|-0.036|0.1153||estimates of left lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1153|-0.0360|0.2912
91776323|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|-0.0362||||0.4592|TWO_SIDED|95.0|-0.1355|0.0631||estimates of right lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0631|-0.1355|0.4592
91520772|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0926|TWO_SIDED|95.0|-6.4|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.5|-6.4|0.0926
91776324|NCT02135861|183433282|OTHER||Mean Difference (Final Values)|-0.0118||||0.7936|TWO_SIDED|95.0|-0.1036|0.08||estimates of right lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0800|-0.1036|0.7936
91776325|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1148||||0.0156|TWO_SIDED|95.0|0.0236|0.2061||estimates of total lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2061|0.0236|0.0156
91776326|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1366||||0.0026|TWO_SIDED|95.0|0.0523|0.2209||estimates of left lung- Pre-exercise|ANOVA|estimates of left lung- Pre-exercise|||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2209|0.0523|0.0026
91776327|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1067||||0.0328|TWO_SIDED|95.0|0.0094|0.204||estimates of right lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2040|0.0094|0.0328
91776328|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1145||||0.0158|TWO_SIDED|95.0|0.0235|0.2056||estimates of left lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2056|0.0235|0.0158
91520773|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.09|TWO_SIDED|95.0|-4.5|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.5|0.0900
91776329|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1776||||0.0002|TWO_SIDED|95.0|0.0917|0.2635||estimates of left lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2635|0.0917|0.0002
91776330|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.0956||||0.0658|TWO_SIDED|95.0|-0.0067|0.1979||estimates of right lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1979|-0.0067|0.0658
91776331|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1194||||0.015|TWO_SIDED|95.0|0.0251|0.2137||estimates of right lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2137|0.0251|0.0150
91776332|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1428||||0.0015|TWO_SIDED|95.0|0.0598|0.2259||estimates of total lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2259|0.0598|0.0015
91776333|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1776|||<|0.0001|TWO_SIDED|95.0|0.1057|0.2496||estimates of left lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2496|0.1057|<.0001
91776334|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.126||||0.0114|TWO_SIDED|95.0|0.0308|0.2212||estimates of right lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2212|0.0308|0.0114
91776335|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1464||||0.0002|TWO_SIDED|95.0|0.0774|0.2153||estimates of left lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2153|0.0774|0.0002
91776336|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.2137|||<|0.0001|TWO_SIDED|95.0|0.1266|0.3008||estimates of left lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3008|0.1266|<.0001
91776337|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1111||||0.025|TWO_SIDED|95.0|0.0151|0.2071||estimates of right lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2071|0.0151|0.0250
91776338|NCT02135861|183433283|OTHER||Mean Difference (Final Values)|0.1458||||0.0052||95.0|0.0475|0.2442||estimates of right lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2442|0.0475|0.0052
91776339|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0524||||0.173|TWO_SIDED|95.0|-0.1292|0.0244||estimates of total lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0244|-0.1292|0.1730
91776340|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0423||||0.2704|TWO_SIDED|95.0|-0.1196|0.0349||estimates of left lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0349|-0.1196|0.2704
91776341|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0515||||0.2072|TWO_SIDED|95.0|-0.1334|0.0303||estimates of right lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0303|-0.1334|0.2072
91776342|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0603||||0.1307|TWO_SIDED|95.0|-0.1398|0.0191||estimates of left lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0191|-0.1398|0.1307
91581703|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.0103||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0103
91776343|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0078||||0.8427|TWO_SIDED|95.0|-0.0879|0.0722||estimates of left lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0722|-0.0879|0.8427
91776344|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0506||||0.1848|TWO_SIDED|95.0|-0.1269|0.0257||estimates of right lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0257|-0.1269|0.1848
91776345|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0413||||0.3408|TWO_SIDED|95.0|-0.1286|0.0461||estimates of right lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0461|-0.1286|0.3408
91776346|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0267||||0.3682|TWO_SIDED|95.0|-0.0866|0.0332||estimates of total lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0332|-0.0866|0.3682
91776347|NCT02135861|183433284|OTHER||Mean Difference (Net)|-0.0201||||0.4531|TWO_SIDED|95.0|-0.0744|0.0342||estimates of left lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0342|-0.0744|0.4531
91776348|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0188||||0.597|TWO_SIDED|95.0|-0.0909|0.0533||estimates of right lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0533|-0.0909|0.5970
91581704|NCT00706433|183053329|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1319
91581705|NCT00706433|183053330|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581706|NCT00706433|183053331|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4378
91581707|NCT00706433|183053332|SUPERIORITY_OR_OTHER|||||||0.343||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3430
91581708|NCT00706433|183053333|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581709|NCT00706433|183053334|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646321|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4782|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4782
91520774|NCT00949884|182916327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.0942|TWO_SIDED|95.0|-4.4|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.4|0.0942
91520775|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3229|TWO_SIDED|95.0|-5.4|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-5.4|0.3229
91520776|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3863|TWO_SIDED|95.0|-5.1|2.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||2.0|-5.1|0.3863
91520777|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1277|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.6|-4.5|0.1277
91520778|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.1799|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.8|-4.3|0.1799
91520779|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2708|TWO_SIDED|95.0|-5.1|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.4|-5.1|0.2708
91520780|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3133|TWO_SIDED|95.0|-5.0|1.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.6|-5.0|0.3133
91520781|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1621|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.7|-3.9|0.1621
91581710|NCT00706433|183053335|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581711|NCT00706433|183053336|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581712|NCT00706433|183053337|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581713|NCT00706433|183053338|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646322|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8998|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8998
91520782|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2314|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.9|-3.7|0.2314
91520783|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.2461|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2461
91520784|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2558|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2558
91520785|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.17|TWO_SIDED|95.0|-3.8|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.7|-3.8|0.1700
91520786|NCT00949884|182916328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2011|TWO_SIDED|95.0|-3.7|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.8|-3.7|0.2011
91581714|NCT00706433|183053339|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581715|NCT00706433|183053340|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581716|NCT00706433|183053341|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646323|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9308|TWO_SIDED|95.0|0.53|1.99|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.99|0.53|0.9308
91776349|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0159||||0.5472|TWO_SIDED|95.0|-0.0693|0.0375||estimates of left lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0375|-0.0693|0.5472
91776350|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0125||||0.6793|TWO_SIDED|95.0|-0.0742|0.0491||estimates of left lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0491|-0.0742|0.6793
91776351|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0249||||0.4806|TWO_SIDED|95.0|-0.0964|0.0466||estimates of right lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0466|-0.0964|0.4806
91776352|NCT02135861|183433284|OTHER||Mean Difference (Final Values)|-0.0029||||0.9379|TWO_SIDED|95.0|-0.0789|0.0731||estimates of right lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0731|-0.0789|0.9379
91776353|NCT02992288|183433304|SUPERIORITY|||||||0.2297||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2297
91776354|NCT02992288|183433304|SUPERIORITY|||||||0.4409||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4409
91581717|NCT00706433|183053342|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581718|NCT00706433|183053343|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581719|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||0.0165||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0165
91581720|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||0.2252||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2252
91646324|NCT01236053|183184695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.5125|TWO_SIDED|95.0|0.41|1.56|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.41|0.5125
91646325|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8655|TWO_SIDED|95.0|0.37|2.33|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.33|0.37|0.8655
91776355|NCT02992288|183433304|SUPERIORITY|||||||0.2842||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2842
91776356|NCT02992288|183433304|SUPERIORITY|||||||0.2534||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2534
91776357|NCT02992288|183433304|SUPERIORITY|||||||0.3842||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.3842
91776358|NCT02992288|183433305|SUPERIORITY|||||||0.8966||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8966
91776359|NCT02992288|183433305|SUPERIORITY|||||||0.9233||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9233
91581721|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0179
91581722|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||0.0233||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0233
91581723|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1573
91581724|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||0.2039||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2039
91581725|NCT00706433|183053344|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581726|NCT00706433|183053345|SUPERIORITY_OR_OTHER|||||||0.1594||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1594
91581727|NCT00706433|183053346|SUPERIORITY_OR_OTHER|||||||0.5838||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5838
91581728|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0064
91776360|NCT02992288|183433305|SUPERIORITY|||||||0.9296||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9296
91581729|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||0.0939||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0939
91581730|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3173
91581731|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||0.2207||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2207
91581732|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||0.0183||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0183
91581733|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0254
91776361|NCT02992288|183433305|SUPERIORITY|||||||0.7357||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7357
91581734|NCT00706433|183053347|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581735|NCT00706433|183053348|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4753
91581736|NCT00706433|183053349|SUPERIORITY_OR_OTHER|||||||0.1728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1728
91581737|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0002
91776362|NCT02992288|183433305|SUPERIORITY|||||||0.9083||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9083
91776363|NCT02992288|183433306|SUPERIORITY|||||||0.4596||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4596
91581738|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||0.5313||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5313
91581739|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
91581740|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
91581741|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0012
91581742|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0015
91581743|NCT00706433|183053350|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646326|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.6482|TWO_SIDED|95.0|0.32|2.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.05|0.32|0.6482
91776364|NCT02992288|183433306|SUPERIORITY|||||||0.7859||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7859
91520787|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1895|TWO_SIDED|95.0|-7.0|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.4|-7.0|0.1895
91520788|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2701|TWO_SIDED|95.0|-6.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-6.5|0.2701
91520789|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.1328|TWO_SIDED|95.0|-5.2|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.7|-5.2|0.1328
91520790|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1778|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.9|-4.9|0.1778
91520791|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.062|TWO_SIDED|95.0|-7.3|0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.2|-7.3|0.0620
91520792|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1011|TWO_SIDED|95.0|-6.9|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.6|-6.9|0.1011
91520793|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0249|TWO_SIDED|95.0|-5.6|-0.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||-0.4|-5.6|0.0249
91520794|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.0497|TWO_SIDED|95.0|-5.2|0.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.0|-5.2|0.0497
91520795|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0552|TWO_SIDED|95.0|-7.1|0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.1|-7.1|0.0552
91520796|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.0767|TWO_SIDED|95.0|-6.8|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.3|-6.8|0.0767
91520797|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0279|TWO_SIDED|95.0|-5.3|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.3|-5.3|0.0279
91520798|NCT00949884|182916329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0434|TWO_SIDED|95.0|-5.0|-0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.1|-5.0|0.0434
91646327|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9003|TWO_SIDED|95.0|0.53|1.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.76|0.53|0.9003
91776365|NCT02992288|183433306|SUPERIORITY|||||||0.5562||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5562
91520799|NCT00949884|182916330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Diastolic blood pressure||-1.8|-6.8|0.0009
91520800|NCT00949884|182916330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.5|-4.7|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Systolic blood pressure||-4.7|-12.5|<0.0001
91520801|NCT03896009|182916403|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91520802|NCT03896009|182916404|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
91520803|NCT00662857|182916405|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.982|||||TWO_SIDED|90.0|0.846|1.141|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.141|0.846|
91520804|NCT00662857|182916406|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.951|||||TWO_SIDED|90.0|0.823|1.099|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.099|0.823|
91520805|NCT00662857|182916407|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3531|||||||Signed Rank Test|||||||0.3531
91520806|NCT00662857|182916408|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.46|||||TWO_SIDED|90.0|0.366|0.578|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||0.578|0.366|
91520807|NCT00998400|182916426|SUPERIORITY|||||||0.03|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.030
91581744|NCT00706433|183053351|SUPERIORITY_OR_OTHER|||||||0.0892||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0892
91581745|NCT00706433|183053352|SUPERIORITY_OR_OTHER|||||||0.4575||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4575
91581746|NCT00706433|183053353|SUPERIORITY_OR_OTHER|||||||0.8848||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8848
91581747|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0008
91581748|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.4091||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4091
91581749|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0176
91581750|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
91581751|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0020
91581752|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0022
91708165|NCT03230838|183309235|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|-1.6|||||TWO_SIDED|95.0|-19.7|17.9|||||Ceftolozane/Tazobactam (C/T) minus Meropenem (Mero)|Difference in Percentage (C/T minus Mero)||17.9|-19.7|
91708166|NCT03230838|183309236|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|1.0|||||TWO_SIDED|95.0|-9.5|5.5|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||5.5|-9.5|
91708167|NCT03230838|183309237|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-7.3|||||TWO_SIDED|95.0|-17.99|10.05|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||10.05|-17.99|
91708168|NCT03230838|183309238|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-5.6|||||TWO_SIDED|95.0|-14.09|8.88|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||8.88|-14.09|
91708169|NCT03230838|183309239|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.0|||||TWO_SIDED|95.0|-17.13|17.4|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||17.40|-17.13|
91708170|NCT03230838|183309240|OTHER|The Miettinen \& Nurminen method stratified by age group with CMH weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.4|||||TWO_SIDED|95.0|-12.67|13.41|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||13.41|-12.67|
91708171|NCT00497055|183309241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.41||95.0|0.66|1.16|||Generalized estimating equation|||||1.16|.66|.41
91708172|NCT00497055|183309242|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
91708173|NCT00497055|183309243|SUPERIORITY_OR_OTHER||||||>=|0.99|||||||Fisher Exact|||||||>=0.99
91708174|NCT02697734|183309246|SUPERIORITY||Odds Ratio (OR)|43.4|||<|0.0001|TWO_SIDED|95.0|7.06|343.19|||Cochran-Mantel-Haenszel|||||343.19|7.06|<.0001
91708175|NCT02033200|183309343|SUPERIORITY_OR_OTHER||LS mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.335||0.8216|TWO_SIDED|95.0|-0.592|0.744|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.744|-0.592|0.8216
91708176|NCT02033200|183309343|SUPERIORITY_OR_OTHER||LS means difference|0.257|STANDARD_ERROR_OF_MEAN|0.258||0.324|TWO_SIDED|95.0|-0.258|0.771|||ANCOVA|||The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.||0.771|-0.258|0.324
91708177|NCT02033200|183309344|SUPERIORITY_OR_OTHER||LS means difference|0.004|STANDARD_ERROR_OF_MEAN|0.014||0.7864|TWO_SIDED|95.0|-0.024|0.031|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||0.031|-0.024|0.7864
91708178|NCT02033200|183309344|SUPERIORITY_OR_OTHER||LS Means difference|-0.022|STANDARD_ERROR_OF_MEAN|0.017||0.1953|TWO_SIDED|95.0|-0.056|0.012|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.012|-0.056|0.1953
91708179|NCT02033200|183309345|SUPERIORITY_OR_OTHER||LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.0101|TWO_SIDED|95.0|-0.28|-0.039|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||-0.039|-0.280|0.0101
91708180|NCT02033200|183309345|SUPERIORITY_OR_OTHER||LS means difference|-0.087|STANDARD_ERROR_OF_MEAN|0.061||0.1583|TWO_SIDED|95.0|-0.209|0.035|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.035|-0.209|0.1583
91708181|NCT02033200|183309346|SUPERIORITY_OR_OTHER||LS means difference|-0.031|STANDARD_ERROR_OF_MEAN|0.359||0.9324|TWO_SIDED|95.0|-0.746|0.685|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.||0.685|-0.746|0.9324
91708182|NCT02033200|183309346|SUPERIORITY_OR_OTHER||LS means difference|0.751|STANDARD_ERROR_OF_MEAN|0.348||0.0343|TWO_SIDED|95.0|0.057|1.44|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.||1.44|0.057|0.0343
91581753|NCT00706433|183053354|SUPERIORITY_OR_OTHER|||||||0.9372||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9372
91646328|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.46|1.56|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.46|0.6000
91776366|NCT02992288|183433306|SUPERIORITY|||||||0.5338||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5338
91520808|NCT00998400|182916427|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520809|NCT00998400|182916428|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520810|NCT00998400|182916429|SUPERIORITY||||||>|0.05|||||||Kaplan-Meier Survival analysis|||||||>0.05
91520811|NCT00998400|182916430|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520812|NCT00998400|182916431|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91776367|NCT02992288|183433306|SUPERIORITY|||||||0.7303||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7303
91520813|NCT00998400|182916432|SUPERIORITY|||||||0.013|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.013
91520814|NCT00998400|182916433|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520815|NCT00998400|182916434|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520816|NCT00998400|182916435|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520817|NCT00998400|182916436|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91776368|NCT02992288|183433307|SUPERIORITY|||||||0.5703||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5703
91776369|NCT02992288|183433307|SUPERIORITY|||||||0.8253||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8253
91520818|NCT00998400|182916437|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
91520819|NCT01904864|182916455|SUPERIORITY||Mean Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.6|||Regression, Linear||Change at 12 weeks compared|||1.6|0.4|<0.001
91520820|NCT05674890|182916456|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|2.49||0.297|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||0.297
91520821|NCT05674890|182916457|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-2.11|STANDARD_DEVIATION|2.81|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
91520822|NCT05674890|182916458|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-48.75|STANDARD_DEVIATION|56.48|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
91520823|NCT00105235|182916469|SUPERIORITY_OR_OTHER||Proportion|0.22|||||TWO_SIDED|95.0|0.086|0.423|||Exact Binomial Confidence Interval|||||.423|.086|
91520824|NCT00105235|182916470|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.3|||Exact Binomial Confidence Interval|||||0.3|0|
91520825|NCT00105235|182916472|SUPERIORITY_OR_OTHER||Proportion|0.2|||||TWO_SIDED|95.0|0.04|0.3|||Exact Binomial Confidence Interval|||||0.3|0.04|
91520826|NCT00105235|182916473|SUPERIORITY_OR_OTHER||Proportion|0.1|||||TWO_SIDED|95.0|0.01|0.2|||Exact Binomial Confidence Interval|||||0.2|0.01|
91776370|NCT02992288|183433307|SUPERIORITY|||||||0.6506||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6506
91776371|NCT02992288|183433307|SUPERIORITY|||||||0.6923||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6923
91776372|NCT02992288|183433307|SUPERIORITY|||||||0.8036||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8036
91776373|NCT02992288|183433308|SUPERIORITY|||||||0.9955||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9955
91776374|NCT02992288|183433308|SUPERIORITY|||||||0.9946||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9946
91776375|NCT02992288|183433308|SUPERIORITY|||||||0.9913||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9913
91776376|NCT02992288|183433308|SUPERIORITY|||||||0.9982||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9982
91776377|NCT02992288|183433308|SUPERIORITY|||||||0.9959||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9959
91581754|NCT00706433|183053355|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2390
91581755|NCT00706433|183053356|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646329|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.567|TWO_SIDED|95.0|0.27|2.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.06|0.27|0.5670
91776378|NCT00656513|183433316|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%||||0.45
91776379|NCT00656513|183433318|SUPERIORITY|||||||0.11||||||Two-sided test of values at 4 months.|Wilcoxon (Mann-Whitney)|||||||0.11
91776380|NCT00656513|183433318|SUPERIORITY|||||||0.31||||||Two-sided test of values at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.31
91776381|NCT00656513|183433318|SUPERIORITY|||||||0.21||||||Two-sided test of values at 15 months.|Wilcoxon (Mann-Whitney)|||||||0.21
91776382|NCT00656513|183433319|SUPERIORITY|||||||0.35||||||4-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.35
91776383|NCT00656513|183433319|SUPERIORITY|||||||0.78||||||4 months Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
91776384|NCT00656513|183433319|SUPERIORITY|||||||0.12||||||4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.12
91776385|NCT00656513|183433319|SUPERIORITY|||||||0.28||||||4-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
91776386|NCT00656513|183433319|SUPERIORITY|||||||0.98||||||6-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.98
91776387|NCT00656513|183433319|SUPERIORITY|||||||0.28||||||6-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
91776388|NCT00656513|183433319|SUPERIORITY|||||||0.13||||||6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.13
91776389|NCT00656513|183433319|SUPERIORITY|||||||0.58||||||6-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
91776390|NCT00656513|183433319|SUPERIORITY|||||||0.88||||||9-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.88
91776391|NCT00656513|183433319|SUPERIORITY|||||||0.09||||||9-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.09
91776392|NCT00656513|183433319|SUPERIORITY|||||||0.49||||||9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.49
91776393|NCT00656513|183433319|SUPERIORITY|||||||0.45||||||9-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
91520827|NCT02052310|182916474|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|0.079|0.287|||ANCOVA|ANCOVA with multiple imputation||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.287|0.079|0.0005
91520828|NCT02052310|182916475|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|3.5|||||TWO_SIDED|95.0|-0.7|7.7||||||For the difference of responder rates between 2 treatment groups, the CI was analyzed from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||7.7|-0.7|
91520829|NCT02052310|182916476|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|4.3|||||TWO_SIDED|95.0|-0.1|8.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||8.7|-0.1|
91646330|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.4353|TWO_SIDED|95.0|0.24|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.24|0.4353
91708183|NCT02033200|183309347|SUPERIORITY_OR_OTHER||LS Means difference|0.017|STANDARD_ERROR_OF_MEAN|0.017||0.3139|TWO_SIDED|95.0|-0.017|0.051|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.051|-0.017|0.3139
91520830|NCT02052310|182916477|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% CI for the treatment difference in LS means of change from baseline Hb averaged over Weeks 28 to 52 lay entirely above -0.75 g/dL.|LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.0148|TWO_SIDED|95.0|0.032|0.296|||Mixed Models Analysis|||Treatment comparison was made using mixed model for repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors except mean qualifying screening hemoglobin (≤8.0 vs. \>8.0 g/dL) as fixed effects.||0.296|0.032|0.0148
91520831|NCT02052310|182916478|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|-18.34|STANDARD_ERROR_OF_MEAN|1.584|<|0.0001|TWO_SIDED|95.0|-21.448|-15.232|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors as fixed effects.||-15.232|-21.448|<0.0001
91581756|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0463
91708184|NCT02033200|183309347|SUPERIORITY_OR_OTHER||LS means difference|-0.002|STANDARD_ERROR_OF_MEAN|0.022||0.9334|TWO_SIDED|95.0|-0.045|0.042|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.042|-0.045|0.9334
91708185|NCT02033200|183309348|SUPERIORITY_OR_OTHER||LS means difference|0.016|STANDARD_ERROR_OF_MEAN|0.055||0.7723|TWO_SIDED|95.0|-0.093|0.125|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.125|-0.093|0.7723
91708186|NCT02033200|183309348|SUPERIORITY_OR_OTHER||LS means difference|0.007|STANDARD_ERROR_OF_MEAN|0.058||0.9107|TWO_SIDED|95.0|-0.109|0.122|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.122|-0.109|0.9107
91708187|NCT02033200|183309349|SUPERIORITY_OR_OTHER||LS Means difference|-0.078|STANDARD_ERROR_OF_MEAN|0.278||0.7787|TWO_SIDED|95.0|-0.632|0.475|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.475|-0.632|0.7787
91708188|NCT02033200|183309349|SUPERIORITY_OR_OTHER||LS means difference|-0.18|STANDARD_ERROR_OF_MEAN|0.344||0.6013|TWO_SIDED|95.0|-0.865|0.504|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.504|-0.865|0.6013
91708189|NCT02033200|183309350|SUPERIORITY_OR_OTHER||LS means difference|0.091|STANDARD_ERROR_OF_MEAN|0.4||0.8209|TWO_SIDED|95.0|-0.705|0.887|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.||0.887|-0.705|0.8209
91708190|NCT02033200|183309350|SUPERIORITY_OR_OTHER||LS means difference|0.227|STANDARD_ERROR_OF_MEAN|0.33||0.4931|TWO_SIDED|95.0|-0.43|0.884|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.||0.884|-0.430|0.4931
91708191|NCT04333225|183309351|OTHER|Other: estimating risk reduction|Risk Ratio (RR)|2.0718||||0.0112|TWO_SIDED|95.0|1.15|3.72|||Chi-squared|||||3.72|1.15|0.0112
91708192|NCT04333225|183309352|OTHER|Other: Estimating hazard ratio|Hazard Ratio (HR)|0.35||||0.0105|TWO_SIDED|95.0|0.17|0.75|||Log Rank|||||0.75|0.17|0.0105
91708193|NCT01124370|183309364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The test was conducted using a 0.05 level of significance.|t-test, 2 sided|||The null hypothesis was that there would be no change in AHI from baseline.||||<.001
91708194|NCT00822328|183309371|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
91776394|NCT00656513|183433319|SUPERIORITY|||||||0.45||||||15-month Physical Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
91776395|NCT00656513|183433319|SUPERIORITY|||||||0.3||||||15-month Pain/Discomfort; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
91776396|NCT00656513|183433319|SUPERIORITY|||||||0.48||||||15-month Personal/Psychological Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.48
91776397|NCT00656513|183433319|SUPERIORITY|||||||0.68||||||15-month Social Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.68
91646331|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.8922|TWO_SIDED|95.0|0.56|1.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.95|0.56|0.8922
91776398|NCT00656513|183433320|SUPERIORITY|||||||0.97||||||4-month score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.97
91646332|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8591|TWO_SIDED|95.0|0.5|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.77|0.50|0.8591
91581757|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||0.1261||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1261
91646333|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4779|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4779
91646334|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8994|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8994
91776399|NCT00656513|183433320|SUPERIORITY|||||||0.83||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.83
91776400|NCT00656513|183433320|SUPERIORITY|||||||0.28||||||9-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
91776401|NCT00656513|183433320|SUPERIORITY|||||||0.89||||||15-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.89
91776402|NCT00656513|183433321|SUPERIORITY|||||||0.54||||||4-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.54
91776403|NCT00656513|183433321|SUPERIORITY|||||||0.99||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
91776404|NCT00656513|183433321|SUPERIORITY|||||||0.56||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.56
91776405|NCT00656513|183433321|SUPERIORITY|||||||0.58||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
91776406|NCT00656513|183433322|SUPERIORITY|||||||0.14||||||Two-sided test, significance level 0.05|t-test, 2 sided|||||||0.14
91776407|NCT00333775|183433343|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0318|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0318
91776408|NCT00333775|183433343|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.72||||0.0036|TWO_SIDED|95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0036
91776409|NCT00333775|183433346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1105|TWO_SIDED|95.0|0.69|1.04|||Log Rank|||||1.04|0.69|0.1105
91776410|NCT00333775|183433346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0241|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||||0.97|0.65|0.0241
91776411|NCT00333775|183433347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6962|TWO_SIDED|95.0|0.62|1.37|||Log Rank|||||1.37|0.62|0.6962
91776412|NCT00333775|183433347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0765|TWO_SIDED|95.0|0.45|1.04|||Log Rank|||||1.04|0.45|0.0765
91776413|NCT03165617|183433348|SUPERIORITY|Success criterion were met as the LL of the 2-sided 95% CI was above 20%.|Absolute Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical Analysis title - Absolute Vaccine Efficacy Any Strain. Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 20% (primary endpoint) using the protocol definition of ILI for the entire age range (2 to \<18 years of age).||62.12|45.67|
91776414|NCT03165617|183433349|SUPERIORITY|Success criteria was met as the LL of the 2-sided 95% CI of the VE estimate was greater than 30% (co-primary endpoint)|Absolute Vaccine Efficacy|54.03|||||TWO_SIDED|95.0|44.8|61.71||||||Statistical analysis title - Absolute Vaccine Efficacy, Any Strain Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 30% (co-primary endpoint) using the protocol definition of ILI for the entire age range (≥ 3 to \<18 years of age).||61.71|44.8|
91776415|NCT03165617|183433350|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
91776416|NCT03165617|183433350|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|50.51|||||TWO_SIDED|95.0|38.43|60.22||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||60.22|38.43|
91776417|NCT03165617|183433350|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|53.33|||||TWO_SIDED|95.0|43.38|61.54||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||61.54|43.38|
91776418|NCT03165617|183433350|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.85|||||TWO_SIDED|95.0|47.37|72.34||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||72.34|47.37|
91776419|NCT03165617|183433351|SUPERIORITY|Absolute Vaccine Efficacy (aVE) for 2 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
91776420|NCT03165617|183433351|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
91776421|NCT03165617|183433351|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||68.05|49.08|
91646335|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.78|TWO_SIDED|95.0|0.57|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.12|0.57|0.7800
91520832|NCT02052310|182916479|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.099||0.8178|TWO_SIDED|95.0|-0.171|0.217|||ANCOVA|ANCOVA multiple imputation||Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.217|-0.171|0.8178
91520833|NCT02052310|182916480|SUPERIORITY|||||||0.00028||||||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, and randomization stratification factors as fixed effects.||||0.00028
91520834|NCT02052310|182916481|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|1.26||||0.3284|TWO_SIDED|95.0|0.791|2.016|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening hemoglobin (\<= 8.0 vs. \>8.0 g/dL) as fixed effects.||2.016|0.791|0.3284
91520835|NCT02563002|182916495|OTHER||Hazard Ratio (HR)|0.59||||0.0001|TWO_SIDED|95.0|0.45|0.79|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.79|0.45|0.0001
91520836|NCT02563002|182916496|OTHER||Hazard Ratio (HR)|0.74||||0.0359|TWO_SIDED|95.0|0.53|1.03|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.03|0.53|0.0359
91520837|NCT02563002|182916497|OTHER||Difference in percentage|12.0||||0.0159|TWO_SIDED|95.0|1.0|22.6||One-sided p-value based on Miettinen \& Nurminen method.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method.|||22.6|1.0|0.0159
91520838|NCT02416492|182916515|SUPERIORITY||Least Square (LS) Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.9||0.0401|TWO_SIDED|95.0||||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||||0.0401
91646336|NCT01236053|183184696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6577|TWO_SIDED|95.0|0.44|1.67|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.67|0.44|0.6577
91646337|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8111|TWO_SIDED|95.0|0.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.59|0.48|0.8111
91646338|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9104|TWO_SIDED|95.0|0.45|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.46|0.45|0.9104
91520839|NCT02416492|182916516|SUPERIORITY||Least Square (LS) Mean Difference|-0.7||||0.1655|TWO_SIDED|95.0|-1.7|0.3||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||0.3|-1.7|0.1655
91520840|NCT02416492|182916517|SUPERIORITY||Least Square (LS) Mean Difference|2.7||||0.3398|TWO_SIDED|95.0|-2.9|8.3|||Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||8.3|-2.9|0.3398
91520841|NCT02416492|182916518|SUPERIORITY||Least Square (LS) Mean Difference|-2.6||||0.8974|TWO_SIDED|95.0|-42.2|37.1||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||37.1|-42.2|0.8974
91776422|NCT03165617|183433351|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
91520842|NCT02416492|182916519|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.8534|TWO_SIDED|95.0|-5.77|4.8||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Upper Extremity Function T Score at Week 24||4.80|-5.77|0.8534
91520843|NCT02416492|182916519|SUPERIORITY||Least Square (LS) Mean Difference|0.41||||0.8443|TWO_SIDED|95.0|-3.78|4.6||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Lower Extremity Function T Score at Week 24||4.60|-3.78|0.8443
91520844|NCT02093663|182916521|OTHER||Odds Ratio (OR)|3.21||||0.039|TWO_SIDED|95.0|1.04|9.88|||Uncorrected Chi-squared Test|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (last observation carried forward \[LOCF\] and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||9.88|1.04|0.039
91646339|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5592|TWO_SIDED|95.0|0.68|2.07|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.07|0.68|0.5592
91520845|NCT02093663|182916522|OTHER||Odds Ratio (OR)|0.99||||0.981|TWO_SIDED|95.0|0.42|2.34||P-value were based on a Cochran-Mantel-Haenszel test stratified by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-value s were presented as descriptive statistics.||2.34|0.42|0.981
91520846|NCT02093663|182916523|OTHER||Difference in proportions|50.0||||0.4|TWO_SIDED|95.0|-19.3|100.0||P-value was calculated based on Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||100.0|-19.3|0.400
91520847|NCT02093663|182916524|OTHER||Difference in proportions|50.0||||0.333|TWO_SIDED|95.0|-19.3|100.0||P-value was based on a Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate.||100.0|-19.3|0.333
91520848|NCT02093663|182916525|OTHER||Difference in Least squares Mean|-5.4||||0.168|TWO_SIDED|95.0|-13.1|2.4||P-value is based on an analysis of covariance (ANCOVA) including treatment arm as a factor and baseline DUCS score as a covariate.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||2.4|-13.1|0.168
91520849|NCT02093663|182916526|OTHER||Difference in proportions|24.5||||0.131|TWO_SIDED|95.0|-1.6|50.6||P-value was based on a continuity-corrected chi-squared test. PUCAI Score was compared between treatment arms using a continuity corrected chi-squared test. Expected cell counts are very low (\< 5), then Fisher's Exact Test is alternative method.|Chi-squared, Corrected|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||50.6|-1.6|0.131
91520850|NCT02093663|182916527|OTHER||Difference in Proportions Percentage|-6.5||||0.539|TWO_SIDED|95.0|-25.3|12.3||P-value is based on a CMH test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||12.3|-25.3|0.539
91776423|NCT03165617|183433352|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.81|||||TWO_SIDED|95.0|51.3|68.46||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||68.46|51.3|
91776424|NCT03165617|183433352|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
91520851|NCT02093663|182916528|OTHER||Difference in proportions|-16.2||||0.129|TWO_SIDED|95.0|-36.0|3.6||P-value was based on a Cochran-Mantel-Haenszel (CMH) test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||3.6|-36.0|0.129
91520852|NCT02093663|182916529|OTHER||Difference in Least squares Mean|3.0||||0.182|TWO_SIDED|95.0|-1.4|7.4||P-value was based on an analysis of covariance (ANCOVA) including treatment arm and with prior response status.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||7.4|-1.4|0.182
91520853|NCT02093663|182916530|OTHER||Difference in proportions|-9.0||||0.194|TWO_SIDED|95.0|-29.1|11.0||P-value was based on a CMH test adjusted by prior response status. Participants with remission (PUCAI \<10) at double-blind maintenance phase at Week 26 was compared between treatment arms using a CMH test stratifying by Week 8 responder status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||11.0|-29.1|0.194
91646340|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8521|TWO_SIDED|95.0|0.6|1.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.60|0.8521
91646341|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5529|TWO_SIDED|95.0|0.26|2.04|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.04|0.26|0.5529
91776425|NCT03165617|183433352|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||68.05|49.08|
91646342|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||0.3275|TWO_SIDED|95.0|0.21|1.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.68|0.21|0.3275
91646343|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.46|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.72|0.46|0.7300
91776426|NCT03165617|183433352|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
91646344|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.4831|TWO_SIDED|95.0|0.41|1.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.53|0.41|0.4831
91646345|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7693|TWO_SIDED|95.0|0.45|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.45|0.7693
91646346|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8189|TWO_SIDED|95.0|0.35|2.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.30|0.35|0.8189
91646347|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.98|0.50|0.9800
91646348|NCT01236053|183184698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4944|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.58|0.39|0.4944
91520854|NCT00508404|182916531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.02|4.45|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||4.45|1.02|
91520855|NCT00508404|182916532|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86|||||TWO_SIDED|95.0|0.88|3.93|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.93|0.88|
91520856|NCT00508404|182916533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.3|3.89|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.89|0.30|
91520857|NCT00508404|182916534|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.283|||||TWO_SIDED|95.0|0.13|0.614|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.614|0.130|
91520858|NCT00508404|182916535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.642|||||TWO_SIDED|95.0|0.99|2.721|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||2.721|0.990|
91520859|NCT00508404|182916536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.464|||||TWO_SIDED|95.0|0.306|0.703|||||Hazard ratio presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.703|0.306|
91520860|NCT00508404|182916537|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.395|||||TWO_SIDED|95.0|0.252|0.618|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.618|0.252|
91520861|NCT00508404|182916538|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.756|||||TWO_SIDED|95.0|0.4|1.43|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.430|0.400|
91520862|NCT00508404|182916539|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.503|1.002|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.002|0.503|
91520863|NCT00508404|182916541|SUPERIORITY_OR_OTHER_LEGACY||Difference in rates|8.34|||||TWO_SIDED|95.0|-4.01|19.08||||||||19.08|-4.01|
91520864|NCT01197508|182916551|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.84||1|TWO_SIDED|95.0|-0.53|2.79||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.79|-0.53|1.000
91581758|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646349|NCT01236053|183184699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||220.5|1.81|0.0144
91646350|NCT01236053|183184699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.79||||0.0743|TWO_SIDED|95.0|0.79|147.0|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||147.0|0.79|0.0743
91646351|NCT01236053|183184700|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
91646352|NCT01236053|183184700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
91646353|NCT01236053|183184701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
91646354|NCT01236053|183184701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
91646355|NCT01236053|183184703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
91776427|NCT03165617|183433353|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.64|||||TWO_SIDED|95.0|53.64|71.48||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||71.48|53.64|
91776428|NCT03165617|183433353|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.04|||||TWO_SIDED|95.0|50.66|72.32||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||72.32|50.66|
91776429|NCT03165617|183433353|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.58|||||TWO_SIDED|95.0|50.25|70.53||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||70.53|50.25|
91776430|NCT03165617|183433353|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|64.78|||||TWO_SIDED|95.0|44.84|77.51||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||77.51|44.84|
91776431|NCT00412984|183433367|SUPERIORITY|With an average 2.1 years follow-up and assuming a stroke rate of 1.20 per hundred patient-years, \~18,000 randomized subjects allocated in a 1:1 ratio to apixaban or warfarin group would be needed to achieve the desired power. These calculations assumed an incidence of 1% loss to follow-up. Non-inferiority for the primary efficacy endpoint will be assessed first. If non-inferiority (using a NI margin of 1.38) is demonstrated then, superiority for the primary efficacy endpoint will be tested|Hazard Ratio (HR)|0.79||||0.0114|TWO_SIDED|95.0|0.66|0.95||2-sided P-value for superiority test|Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status. (experienced, naïve).|apixaban / warfarin|With 448 subjects with confirmed strokes or systemic emboli, study would have at least 90% power to meet both regulatory definitions of non-inferiority described in the following: (1) the non-inferiority (NI) of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for relative risk (RR) was less than 1.38; (2) the NI of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 99% CI for RR was less than 1.44.||.95|.66|0.0114
91776432|NCT00412984|183433369|SUPERIORITY|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.6|0.8|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|||0.80|0.60|<.0001
91776433|NCT00412984|183433371|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0465|TWO_SIDED|95.0|0.8|1.0|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"||1.00|0.80|0.0465
91776434|NCT00412984|183433372|OTHER||Hazard Ratio (HR)|0.92||||0.422|TWO_SIDED|95.0|0.74|1.13||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Ischemic or Unspecified Stroke||1.13|0.74|0.4220
91776435|NCT00412984|183433372|OTHER||Hazard Ratio (HR)|0.51||||0.0006|TWO_SIDED|95.0|0.35|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Hemorrhagic Stroke||0.75|0.35|0.0006
91776436|NCT00412984|183433372|OTHER||Hazard Ratio (HR)|0.87||||0.702|TWO_SIDED|95.0|0.44|1.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Systemic Embolism||1.75|0.44|0.7020
91776437|NCT00412984|183433372|OTHER||Hazard Ratio (HR)|0.88||||0.372|TWO_SIDED|95.0|0.66|1.17||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Myocardial Infarction||1.17|0.66|0.3720
91776438|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding||0.86|0.69|<.0001
91776439|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.89||||0.0192|TWO_SIDED|95.0|0.81|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / All-Cause Death||0.98|0.81|0.0192
91776440|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding / All-Cause Death||0.92|0.78|0.0002
91776441|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.88||||0.0107|TWO_SIDED|95.0|0.8|0.97||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / MI / All-Cause Death||0.97|0.80|0.0107
91776442|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.9||||0.0432|TWO_SIDED|95.0|0.82|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Ischemic or Unspecified Stroke / All-Cause Death||1.00|0.82|0.0432
91520865|NCT01197508|182916551|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.22|2.13|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.13|-1.22|1.000
91520866|NCT01197508|182916551|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.88||1|TWO_SIDED|95.0|-1.21|2.22|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-1.21|1.000
91520867|NCT01197508|182916552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.17||0.144|TWO_SIDED|95.0|0.45|1.12|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.12|0.45|0.144
91520868|NCT01197508|182916552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.17||0.203|TWO_SIDED|95.0|0.47|1.17|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.17|0.47|0.203
91520869|NCT01197508|182916552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.32|0.82|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.82|0.32|0.005
91520870|NCT01197508|182916553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.636|TWO_SIDED|95.0|0.54|1.45|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.45|0.54|0.636
91520871|NCT01197508|182916553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.19||0.215|TWO_SIDED|95.0|0.44|1.2|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.20|0.44|0.215
91646356|NCT01236053|183184703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
91776443|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.88||||0.0167|TWO_SIDED|95.0|0.79|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Hemorrhagic Stroke / All-Cause Death||0.98|0.79|0.0167
91776444|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.89||||0.0464|TWO_SIDED|95.0|0.8|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Systemic Embolism / All-Cause Death||1.00|0.80|0.0464
91520872|NCT01197508|182916553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|STANDARD_ERROR_OF_MEAN|0.15||0.034|TWO_SIDED|95.0|0.35|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.35|0.034
91520873|NCT01197508|182916554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.37||0.711|TWO_SIDED|95.0|0.36|1.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.99|0.36|0.711
91520874|NCT01197508|182916554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.34||0.594|TWO_SIDED|95.0|0.34|1.85|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.85|0.34|0.594
91520875|NCT01197508|182916554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.49||0.749|TWO_SIDED|95.0|0.5|2.65|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.65|0.50|0.749
91520876|NCT01197508|182916555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.16||0.037|TWO_SIDED|95.0|0.28|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.28|0.037
91520877|NCT01197508|182916555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|0.38|1.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.25|0.38|0.222
91581759|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91646357|NCT01236053|183184704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0066|TWO_SIDED|95.0|1.21|3.32|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.32|1.21|0.0066
91776445|NCT00412984|183433373|OTHER||Hazard Ratio (HR)|0.89||||0.0253|TWO_SIDED|95.0|0.8|0.99||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Myocardial Infarction / All-Cause Death||0.99|0.80|0.0253
91776446|NCT00412984|183433375|OTHER||Hazard Ratio (HR)|0.8||||0.0098|TWO_SIDED|95.0|0.67|0.95||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite Stroke/Systemic Embolism/Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants||0.95|0.67|0.0098
91776447|NCT00412984|183433378|OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.61|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.61|<.0001
91520878|NCT01197508|182916555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.17||0.042|TWO_SIDED|95.0|0.28|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.98|0.28|0.042
91520879|NCT01197508|182916556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.41||0.913|TWO_SIDED|95.0|0.48|2.27|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.27|0.48|0.913
91520880|NCT01197508|182916556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.37||0.841|TWO_SIDED|95.0|0.42|2.01|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.01|0.42|0.841
91520881|NCT01197508|182916556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.26||0.239|TWO_SIDED|95.0|0.26|1.39|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.39|0.26|0.239
91520882|NCT01197508|182916557|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.705||0.12|TWO_SIDED|95.0|-0.288|2.481|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.481|-0.288|0.120
91520883|NCT01197508|182916557|SUPERIORITY_OR_OTHER||LS mean|0.95|STANDARD_ERROR_OF_MEAN|0.715||0.184|TWO_SIDED|95.0|-0.452|2.354|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.354|-0.452|0.184
91520884|NCT01197508|182916557|SUPERIORITY_OR_OTHER||LS mean|2.09|STANDARD_ERROR_OF_MEAN|0.711||0.003|TWO_SIDED|95.0|0.692|3.484|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.484|0.692|0.003
91520885|NCT01197508|182916558|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.131||95.0|-0.05|0.42|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.42|-0.05|0.131
91520886|NCT01197508|182916558|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.551|TWO_SIDED|95.0|-0.17|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.17|0.551
91520887|NCT01197508|182916558|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.645|TWO_SIDED|95.0|-0.19|0.3|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.30|-0.19|0.645
91520888|NCT01197508|182916559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.046|TWO_SIDED|95.0|0.38|0.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.99|0.38|0.046
91520889|NCT01197508|182916559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.051|TWO_SIDED|95.0|0.38|1.0|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.00|0.38|0.051
91520890|NCT01197508|182916559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.15||0.04|TWO_SIDED|95.0|0.37|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.98|0.37|0.040
91520891|NCT01197508|182916560|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.66||0.273|TWO_SIDED|95.0|-0.58|2.03|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.03|-0.58|0.273
91520892|NCT01197508|182916560|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.315|TWO_SIDED|95.0|-0.65|2.0|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.00|-0.65|0.315
91520893|NCT01197508|182916560|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.67||0.078|TWO_SIDED|95.0|-0.13|2.51|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.51|-0.13|0.078
91520894|NCT01197508|182916561|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.59|TWO_SIDED|95.0|-0.68|1.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.19|-0.68|0.590
91776448|NCT00412984|183433380|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.68|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.68|<.0001
91776449|NCT00412984|183433381|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.6||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe GUSTO bleeding events||0.60|0.35|<.0001
91776450|NCT00412984|183433381|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.71||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe or Moderate GUSTO bleeding events||0.71|0.50|<.0001
91776451|NCT00412984|183433382|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Major TIMI bleeding event||0.70|0.46|<.0001
91776452|NCT00412984|183433382|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.54|0.75|||Cox Proportional Hazard Model||apixaban / warfarin|Major or Minor TIMI bleeding criteria||0.75|0.54|<.0001
91776453|NCT00412984|183433384|OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.83||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.83|0.65|<.0001
91776454|NCT02435212|183433409|SUPERIORITY||Least squares mean|2.58|STANDARD_ERROR_OF_MEAN|2.803||0.3598|TWO_SIDED|95.0|-2.99|8.15|||ANCOVA|||||8.15|-2.99|0.3598
91776455|NCT02435212|183433410|SUPERIORITY||Least squares mean|176.36|STANDARD_ERROR_OF_MEAN|153.933||0.2546|TWO_SIDED|95.0|-129.0|481.72|||ANCOVA|||||481.72|-129.00|0.2546
91776456|NCT04531176|183433456|NON_INFERIORITY|The results of non-inferiority test results are between pairwise groups. Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison.||||||0.004||||||The non-inferiority regions were set to be 1% for weight loss change. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.004
91776457|NCT04531176|183433457|NON_INFERIORITY|Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison||||||0.05||||||The non-inferiority regions were set to be 0.5% for A1C. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.05
91776458|NCT00214045|183433458|SUPERIORITY_OR_OTHER|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
91776459|NCT00214045|183433458|NON_INFERIORITY_OR_EQUIVALENCE|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
91776460|NCT01451606|183433466|SUPERIORITY|||||||0.52||||||Note that sample size was well below our target, making this test very low power.|Wilcoxon (Mann-Whitney)|||||||0.52
91776461|NCT01451606|183433467|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91776462|NCT03155724|183433480|SUPERIORITY||||||<|0.0001|||||||Exact, binomial, one-sided|||The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing the binomial proportion of 'improved' patients to 3.0% with power of 80% and type 1 error (alpha) of 0.0224. A pre-planned interim analysis at 45 patients required a type 1 error (alpha) of 0.0026 to demonstrate significance.||||<0.0001
91776463|NCT04567628|183433507|OTHER||||||=|0.003|||||||Spearman's Rank Correlation|||||||=0.003
91776464|NCT04567628|183433508|OTHER||||||=|0.25||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||=0.25
91776465|NCT04567628|183433511|OTHER||||||<|0.001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.001
91776466|NCT04567628|183433513|OTHER||||||<|0.0001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.0001
91776467|NCT02121535|183433564|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|101.97|||||TWO_SIDED|90.0|98.94|105.08|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||105.08|98.94|
91776468|NCT02121535|183433565|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|103.77|||||TWO_SIDED|90.0|97.03|110.99|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||110.99|97.03|
91776469|NCT02121535|183433566|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.24|||||TWO_SIDED|90.0|96.8|103.8|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||103.80|96.80|
91776470|NCT02121535|183433567|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.42|||||TWO_SIDED|90.0|97.94|100.93|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||100.93|97.94|
91776471|NCT02121535|183433568|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.5|||||TWO_SIDED|90.0|98.08|100.94|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||100.94|98.08|
91776472|NCT02121535|183433569|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.07|||||TWO_SIDED|90.0|98.45|101.72|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||101.72|98.45|
91776473|NCT02121535|183433570|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|110.16|||||TWO_SIDED|90.0|106.87|113.54|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||113.54|106.87|
91776474|NCT02121535|183433571|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.3|||||TWO_SIDED|90.0|102.53|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||106.10|102.53|
91776475|NCT02121535|183433572|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.37|||||TWO_SIDED|90.0|102.68|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||106.10|102.68|
91776476|NCT04944992|183433573|SUPERIORITY||Difference in least squared means|30.4|||<|0.0001|TWO_SIDED|90.0|22.1|38.7|||Mixed Models Analysis|||||38.7|22.1|<0.0001
91776477|NCT04944992|183433574|OTHER|Difference (Efinopegdutide - Semaglutide) in %|difference in percentage|16.3||||||95.0|3.5|29.1||||||||29.1|3.5|
91776478|NCT04944992|183433575|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in percentage|5.6||||||95.0|0.4|13.5||||||||13.5|0.4|
91776479|NCT04944992|183433576|SUPERIORITY||Difference in least squared means|6.1|||<|0.001|TWO_SIDED|90.0|4.6|7.7|||Mixed Models Analysis|||||7.7|4.6|<0.001
91776480|NCT04944992|183433577|SUPERIORITY||Difference in Least Squared Means|-1.4||||0.085|TWO_SIDED|90.0|-2.7|-0.1|||Mixed Models Analysis|||||-0.1|-2.7|0.085
91776481|NCT04944992|183433578|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in Least Squared Means|-7.2|||||TWO_SIDED|90.0|-11.2|-3.1||||||||-3.1|-11.2|
91776482|NCT04944992|183433579|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.7||||||90.0|-10.9|-0.6||||||||-0.6|-10.9|
91776483|NCT04944992|183433580|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-11.7||||||90.0|-15.8|-7.7||||||||-7.7|-15.8|
91776484|NCT04944992|183433581|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-6.1||||||90.0|-12.0|-0.1||||||||-0.1|-12.0|
91776485|NCT04944992|183433582|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-7.6|||||TWO_SIDED|90.0|-14.3|-0.9||||||||-0.9|-14.3|
91776486|NCT04944992|183433583|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.4|||||TWO_SIDED|90.0|-10.4|-0.4||||||||-0.4|-10.4|
91776487|NCT05366738|183433584|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.36|||||TWO_SIDED|90.0|97.64|109.41||||||||109.41|97.64|
91776488|NCT05366738|183433584|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.83|||||TWO_SIDED|90.0|92.42|103.56||||||||103.56|92.42|
91776489|NCT05366738|183433585|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|102.56|||||TWO_SIDED|90.0|97.25|108.15||||||||108.15|97.25|
91776490|NCT05366738|183433585|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.61|||||TWO_SIDED|90.0|92.55|102.93||||||||102.93|92.55|
91776491|NCT05366738|183433586|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.96|||||TWO_SIDED|90.0|96.49|112.0||||||||112.00|96.49|
91581760|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||0.0947||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0947
91776492|NCT05366738|183433586|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|100.6|||||TWO_SIDED|90.0|93.38|108.39||||||||108.39|93.38|
91776493|NCT02798627|183433592|SUPERIORITY||||||=|0.97|||||||Chi-squared|||||||=0.97
91776494|NCT03821402|183433594|SUPERIORITY|||||||0.7645|||||||ANCOVA|||||||0.7645
91776495|NCT03821402|183433594|SUPERIORITY|||||||0.5509|||||||ANCOVA|||||||0.5509
91776496|NCT03821402|183433594|SUPERIORITY|||||||0.0488|||||||ANCOVA|||||||0.0488
91776497|NCT03821402|183433595|SUPERIORITY|||||||0.3698|||||||ANCOVA|||||||0.3698
91776498|NCT03821402|183433595|SUPERIORITY|||||||0.1972|||||||ANCOVA|||||||0.1972
91776499|NCT03821402|183433595|SUPERIORITY|||||||0.2037|||||||ANCOVA|||||||0.2037
91776500|NCT03821402|183433600|SUPERIORITY|||||||0.4324|||||||ANCOVA|||||||0.4324
91776501|NCT03821402|183433600|SUPERIORITY|||||||0.3893|||||||ANCOVA|||||||0.3893
91776502|NCT03821402|183433600|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
91646358|NCT01236053|183184704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0494|TWO_SIDED|95.0|1.0|2.82|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.82|1.00|0.0494
91646359|NCT01236053|183184704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0006|TWO_SIDED|95.0|1.33|2.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.82|1.33|0.0006
91520895|NCT01197508|182916561|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.679|TWO_SIDED|95.0|-0.74|1.14|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.14|-0.74|0.679
91520896|NCT01197508|182916561|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.53|-0.35|0.215
91520897|NCT01197508|182916562|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.61||0.052|TWO_SIDED|95.0|-0.01|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.01|0.052
91520898|NCT01197508|182916562|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.874|TWO_SIDED|95.0|-1.11|1.3|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.30|-1.11|0.874
91520899|NCT01197508|182916562|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.099|TWO_SIDED|95.0|-0.19|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.19|0.099
91520900|NCT01197508|182916563|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.69||0.394|TWO_SIDED|95.0|-0.77|1.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.95|-0.77|0.394
91520901|NCT01197508|182916563|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.712|TWO_SIDED|95.0|-1.11|1.63|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.63|-1.11|0.712
91520902|NCT01197508|182916563|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.71||0.167|TWO_SIDED|95.0|-0.41|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.41|0.167
91520903|NCT01197508|182916564|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|0.75||0.046|TWO_SIDED|95.0|0.02|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|0.02|0.046
91520904|NCT01197508|182916564|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.681|TWO_SIDED|95.0|-1.17|1.79|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.79|-1.17|0.681
91520905|NCT01197508|182916564|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.77||0.087|TWO_SIDED|95.0|-0.19|2.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.84|-0.19|0.087
91520906|NCT01197508|182916565|SUPERIORITY_OR_OTHER||LS mean|0.98|STANDARD_ERROR_OF_MEAN|0.736||1|TWO_SIDED|95.0|-0.464|2.427||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.427|-0.464|1.000
91646360|NCT01236053|183184704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0138|TWO_SIDED|95.0|1.11|2.41|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.41|1.11|0.0138
91646361|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0006|TWO_SIDED|95.0|1.66|6.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.53|1.66|0.0006
91646362|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.002|TWO_SIDED|95.0|1.5|6.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.05|1.50|0.0020
91776503|NCT03821402|183433601|SUPERIORITY|||||||0.0562|||||||ANCOVA|||||||0.0562
91776504|NCT03821402|183433601|SUPERIORITY|||||||0.015|||||||ANCOVA|||||||0.0150
91520907|NCT01197508|182916565|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-0.74|2.188||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.188|-0.740|1.000
91520908|NCT01197508|182916565|SUPERIORITY_OR_OTHER||LS mean|0.85|STANDARD_ERROR_OF_MEAN|0.762||1|TWO_SIDED|95.0|-0.649|2.346||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.346|-0.649|1.000
91520909|NCT01197508|182916566|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.914|TWO_SIDED|95.0|-0.54|0.61|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.61|-0.54|0.914
91520910|NCT01197508|182916566|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.446|TWO_SIDED|95.0|-0.36|0.81|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.81|-0.36|0.446
91520911|NCT01197508|182916566|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.656|TWO_SIDED|95.0|-0.47|0.75|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.75|-0.47|0.656
91520912|NCT01197508|182916567|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.248|TWO_SIDED|95.0|-0.21|0.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.82|-0.21|0.248
91520913|NCT01197508|182916567|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.498|TWO_SIDED|95.0|-0.34|0.7|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.70|-0.34|0.498
91520914|NCT01197508|182916567|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.441|TWO_SIDED|95.0|-0.32|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.74|-0.32|0.441
91520915|NCT01197508|182916568|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.26||0.174|TWO_SIDED|95.0|-0.16|0.87|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.87|-0.16|0.174
91520916|NCT01197508|182916568|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.402|TWO_SIDED|95.0|-0.3|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.74|-0.30|0.402
91520917|NCT01197508|182916568|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.197|TWO_SIDED|95.0|-0.18|0.88|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.88|-0.18|0.197
91520918|NCT01197508|182916569|SUPERIORITY_OR_OTHER||LS mean|-1.47|STANDARD_ERROR_OF_MEAN|1.643||0.371|TWO_SIDED|95.0|-4.697|1.756|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.756|-4.697|0.371
91520919|NCT01197508|182916569|SUPERIORITY_OR_OTHER||LS mean|-1.32|STANDARD_ERROR_OF_MEAN|1.672||0.432|TWO_SIDED|95.0|-4.597|1.967|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.967|-4.597|0.432
91776505|NCT03821402|183433601|SUPERIORITY|||||||0.0092|||||||ANCOVA|||||||0.0092
91776506|NCT05024032|183433602|SUPERIORITY||LS Mean Difference|-12.0|||<|0.001|TWO_SIDED|95.0|-14.8|-9.3|||Mixed Models Analysis|||||-9.3|-14.8|<0.001
91776507|NCT05024032|183433602|SUPERIORITY||LS Mean Difference|-17.5|||<|0.001|TWO_SIDED|95.0|-20.3|-14.8|||Mixed Models Analysis|||||-14.8|-20.3|<0.001
91776508|NCT05024032|183433603|SUPERIORITY||Odds Ratio (OR)|23.11|||<|0.001|TWO_SIDED|95.0|8.8|60.69|||Regression, Logistic|||||60.69|8.80|<0.001
91776509|NCT05024032|183433603|SUPERIORITY||Odds Ratio (OR)|26.53|||<|0.001|TWO_SIDED|95.0|9.61|73.24|||Regression, Logistic|||||73.24|9.61|<0.001
91776510|NCT05024032|183433604|SUPERIORITY||LS Mean Difference|-7.2|||<|0.001|TWO_SIDED|95.0|-8.8|-5.5|||Mixed Models Analysis|||||-5.5|-8.8|<0.001
91776511|NCT05024032|183433604|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-10.9|-7.5|||Mixed Models Analysis|||||-7.5|-10.9|<0.001
91646363|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0013|TWO_SIDED|95.0|1.43|4.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.34|1.43|0.0013
91708195|NCT00822328|183309373|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
91708196|NCT05811026|183309389|SUPERIORITY||Median Difference (Net)|5.0||||0.075|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.075
91708197|NCT05811026|183309390|SUPERIORITY||Median Difference (Net)|0.17||||0.4727|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4727
91708198|NCT05811026|183309391|SUPERIORITY||Median Difference (Net)|-1.5||||0.7326|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.7326
91520920|NCT01197508|182916569|SUPERIORITY_OR_OTHER||LS mean|-2.71|STANDARD_ERROR_OF_MEAN|1.672||0.105|TWO_SIDED|95.0|-5.992|0.573|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.573|-5.992|0.105
91520921|NCT01197508|182916570|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.09|-0.29|0.312
91520922|NCT01197508|182916570|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.885|TWO_SIDED|95.0|-0.18|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.18|0.885
91520923|NCT01197508|182916570|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.067|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.01|-0.37|0.067
91520924|NCT01197508|182916571|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.152|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.05|-0.33|0.152
91520925|NCT01197508|182916571|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.078|TWO_SIDED|95.0|-0.37|0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.02|-0.37|0.078
91520926|NCT01197508|182916571|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.41|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||-0.02|-0.41|0.033
91520927|NCT01197508|182916572|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0181||0.543|TWO_SIDED|95.0|-0.0465|0.0245||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0245|-0.0465|0.543
91520928|NCT01197508|182916572|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.0183||0.998|TWO_SIDED|95.0|-0.036|0.0361||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0361|-0.0360|0.998
91520929|NCT01197508|182916572|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0188||0.743|TWO_SIDED|95.0|-0.0432|0.0308||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0308|-0.0432|0.743
91520930|NCT01197508|182916572|SUPERIORITY_OR_OTHER||LS mean|-2.3|STANDARD_ERROR_OF_MEAN|1.95||0.244|TWO_SIDED|95.0|-6.1|1.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.56|-6.10|0.244
91646364|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.008|TWO_SIDED|95.0|1.22|3.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.80|1.22|0.0080
91708199|NCT05811026|183309392|SUPERIORITY||Median Difference (Net)|0.61||||0.0757|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0757
91708200|NCT05811026|183309393|SUPERIORITY||Median Difference (Net)|37.75||||0.0376|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0376
91708201|NCT05811026|183309394|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.3123|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3123
91708202|NCT05811026|183309395|SUPERIORITY||Median Difference (Final Values)|1.0||||0.1009|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.1009
91708203|NCT05811026|183309396|SUPERIORITY||Mean Difference (Net)|5.5||||0.0088|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0088
91708204|NCT05811026|183309397|SUPERIORITY||Median Difference (Net)|-0.03||||0.4274|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4274
91708205|NCT05811026|183309398|SUPERIORITY||Mean Difference (Net)|1.75||||0.6497|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6497
91776512|NCT05024032|183433605|SUPERIORITY||Odds Ratio (OR)|13.19|||<|0.001|TWO_SIDED|95.0|5.63|30.89|||Regression, Logistic|||||30.89|5.63|<0.001
91776513|NCT05024032|183433605|SUPERIORITY||Odds Ratio (OR)|28.58|||<|0.001|TWO_SIDED|95.0|11.23|72.71|||Regression, Logistic|||||72.71|11.23|<0.001
91776514|NCT05024032|183433606|SUPERIORITY||Odds Ratio (OR)|25.64|||<|0.001|TWO_SIDED|95.0|6.68|98.49|||Regression, Logistic|||||98.49|6.68|<0.001
91776515|NCT05024032|183433606|SUPERIORITY||Odds Ratio (OR)|69.79|||<|0.001|TWO_SIDED|95.0|17.69|275.37|||Regression, Logistic|||||275.37|17.69|<0.001
91776516|NCT05024032|183433607|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
91520931|NCT01197508|182916572|SUPERIORITY_OR_OTHER||LS mean|-1.7|STANDARD_ERROR_OF_MEAN|1.98||0.389|TWO_SIDED|95.0|-5.59|2.18||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.18|-5.59|0.389
91520932|NCT01197508|182916572|SUPERIORITY_OR_OTHER||LS mean|-2.8|STANDARD_ERROR_OF_MEAN|2.02||0.165|TWO_SIDED|95.0|-6.79|1.16||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.16|-6.79|0.165
91520933|NCT02629991|182916582|SUPERIORITY|||||||0.059||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.059
91520934|NCT02629991|182916583|SUPERIORITY|||||||0.088||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.088
91520935|NCT02629991|182916584|SUPERIORITY|||||||0.027|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.027
91520936|NCT02629991|182916585|SUPERIORITY|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.16|||||||Mixed effects model|||||||0.16
91520937|NCT02629991|182916586|SUPERIORITY|||||||0.69|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.69
91520938|NCT02629991|182916587|SUPERIORITY|||||||0.034||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.034
91520939|NCT02629991|182916588|SUPERIORITY|||||||0.009|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.009
91520940|NCT02629991|182916589|SUPERIORITY|||||||0.033|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.033
91520941|NCT02629991|182916590|SUPERIORITY|||||||0.78|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.78
91520942|NCT02629991|182916591|SUPERIORITY|||||||0.53|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.53
91520943|NCT02799784|182916592|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (UMEC/VI 62.5/25 mcg versus TIO/OLO 5/5 mcg) treatment difference is above -50 milliliter then UMEC/VI 62.5/25 mcg was to be considered non-inferior to TIO/OLO 5/5 mcg.|Mean Difference (Final Values)|0.053|||<|0.001|TWO_SIDED|95.0|0.026|0.08|||Mixed Models Analysis|||||0.080|0.026|<0.001
91708206|NCT05811026|183309399|SUPERIORITY||Median Difference (Net)|0.54||||0.0006|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0006
91708207|NCT05811026|183309400|SUPERIORITY||Median Difference (Net)|34.5||||0.0002|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0002
91776517|NCT05024032|183433607|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-16.0|-11.3|||Mixed Models Analysis|||||-11.3|-16.0|<0.001
91776518|NCT05024032|183433608|SUPERIORITY||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-13.5|-8.3|||Mixed Models Analysis|||||-8.3|-13.5|<0.001
91776519|NCT05024032|183433608|SUPERIORITY||LS Mean Difference|-16.0|||<|0.001|TWO_SIDED|95.0|-18.6|-13.4|||Mixed Models Analysis|||||-13.4|-18.6|<0.001
91776520|NCT05024032|183433609|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-4.8|-3.1|||Mixed Models Analysis|||||-3.1|-4.8|<0.001
91776521|NCT05024032|183433609|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|95.0|-6.4|-4.8|||Mixed Models Analysis|||||-4.8|-6.4|<0.001
91776522|NCT05024032|183433610|SUPERIORITY||LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.46|-0.28|||Mixed Models Analysis|||||-0.28|-0.46|<0.001
91776523|NCT05024032|183433610|OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.48|-0.29|||Mixed Models Analysis|||||-0.29|-0.48|<0.001
91776524|NCT05024032|183433611|SUPERIORITY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.61|-0.32|||Mixed Models Analysis|||||-0.32|-0.61|<0.001
91776525|NCT05024032|183433611|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4|||Mixed Models Analysis|||||-0.40|-0.69|<0.001
91776526|NCT05024032|183433612|SUPERIORITY||LS Mean Difference|1.2||||0.044|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.044
91776527|NCT05024032|183433612|SUPERIORITY||LS Mean Difference|1.2||||0.05|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.050
91776528|NCT05024032|183433613|SUPERIORITY||LS Mean Difference|7.8|||<|0.001|TWO_SIDED|95.0|3.7|11.8|||ANCOVA|||||11.8|3.7|<0.001
91776529|NCT05024032|183433613|SUPERIORITY||LS Mean Difference|8.5|||<|0.001|TWO_SIDED|95.0|4.4|12.7|||ANCOVA|||||12.7|4.4|<0.001
91520944|NCT03086330|182916648|OTHER||Treatment difference|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.24|||ANCOVA|||The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-1.24|-1.61|<0.0001
91581761|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||0.0886||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0886
91581762|NCT00706433|183053357|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581763|NCT00706433|183053358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
91581764|NCT00706433|183053358|SUPERIORITY_OR_OTHER|||||||0.0255||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0255
91581765|NCT00706433|183053358|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0576
91581766|NCT00706433|183053358|SUPERIORITY_OR_OTHER|||||||0.0686||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0686
91581767|NCT00706433|183053358|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0004
91581768|NCT00706433|183053358|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
91581769|NCT00706433|183053358|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581770|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0006
91581771|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
91581772|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581773|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581774|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||0.0097||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0097
91776530|NCT05024032|183433614|SUPERIORITY||LS Mean Difference|-4.8|||<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||Mixed Models Analysis|||||-2.7|-6.9|<0.001
91581775|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0146
91581776|NCT00706433|183053359|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581777|NCT00706433|183053360|SUPERIORITY_OR_OTHER|||||||0.4235||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4235
91581778|NCT00706433|183053361|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581779|NCT00706433|183053362|SUPERIORITY_OR_OTHER|||||||0.0865||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0865
91581780|NCT00706433|183053363|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6230
91776531|NCT05024032|183433615|SUPERIORITY||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Mixed Models Analysis|||||-3.1|-9.1|<0.001
91776532|NCT05024032|183433616|SUPERIORITY||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-0.51|-0.11||||||||-0.11|-0.51|
91776533|NCT05024032|183433617|SUPERIORITY||LS Mean Difference|0.09|||||TWO_SIDED|95.0|0.03|0.14||||||||0.14|0.03|
91776534|NCT05024032|183433618|SUPERIORITY||LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.25|0.13||||||||0.13|-0.25|
91776535|NCT05024032|183433619|SUPERIORITY||LS Mean Difference|-0.25|||||TWO_SIDED|95.0|-0.34|-0.16||||||||-0.16|-0.34|
91776536|NCT05024032|183433620|SUPERIORITY||LS Mean Difference|-0.58|||||TWO_SIDED|95.0|-0.79|-0.37||||||||-0.37|-0.79|
91776537|NCT05024032|183433621|SUPERIORITY||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.12|-0.01||||||||-0.01|-0.12|
91581781|NCT00706433|183053364|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0963
91581782|NCT00706433|183053365|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4814
91581783|NCT00706433|183053366|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7153
91581784|NCT00706433|183053367|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3832
91581785|NCT00706433|183053368|SUPERIORITY_OR_OTHER|||||||0.2908||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2908
91581786|NCT00706433|183053369|SUPERIORITY_OR_OTHER|||||||0.8096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8096
91581787|NCT00706433|183053370|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
91581788|NCT00706433|183053371|SUPERIORITY_OR_OTHER|||||||0.3208||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3208
91708208|NCT05811026|183309401|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6231|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6231
91776538|NCT05024032|183433622|SUPERIORITY||LS Mean Difference|-6.3|||||TWO_SIDED|95.0|-8.6|-4.0||||||||-4.0|-8.6|
91581789|NCT00706433|183053372|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581790|NCT00706433|183053373|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
91581791|NCT04101318|183053376|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.625|TWO_SIDED|95.0|-0.38|0.62||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.62|-0.38|0.625
91581792|NCT04101318|183053377|SUPERIORITY||Odds Ratio (OR)|1.737||||0.036|TWO_SIDED|95.0|1.038|2.908||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for itching evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.908|1.038|0.036
91581793|NCT04101318|183053378|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.202|TWO_SIDED|95.0|-0.9|0.2||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|The mode had following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.20|-0.90|0.202
91581794|NCT04101318|183053379|SUPERIORITY||Odds Ratio (OR)|1.369||||0.267|TWO_SIDED|95.0|0.781|2.401||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for pain evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.401|0.781|0.267
91581795|NCT04101318|183053380|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.545|TWO_SIDED|95.0|-0.57|0.3||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.30|-0.57|0.545
91581796|NCT04101318|183053381|SUPERIORITY||Odds Ratio (OR)|1.316||||0.293|TWO_SIDED|95.0|0.783|2.211||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for burning evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.211|0.783|0.293
91581797|NCT04101318|183053382|SUPERIORITY||Odds Ratio (OR)|0.82||||0.375|TWO_SIDED|95.0|0.53|1.27||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|There is no difference between the two arms.||1.27|0.53|0.375
91581798|NCT04101318|183053383|SUPERIORITY||Odds Ratio (OR)|0.83||||0.482|TWO_SIDED|95.0|0.49|1.4||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||1.40|0.49|0.482
91708209|NCT05811026|183309402|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3327|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3327
91708210|NCT05811026|183309403|SUPERIORITY||Median Difference (Net)|7.25||||0.0752|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0752
91776539|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.046||||0.085|TWO_SIDED|95.0|-0.006|0.098|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.098|-0.006|0.085
91581799|NCT04101318|183053384|SUPERIORITY||Odds Ratio (OR)|0.7||||0.151|TWO_SIDED|95.0|0.43|1.14||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects||Null hypothesis: There is no difference between the two arms.|Odds ratio, marginal= Arm1/Arm2|1.14|0.43|0.151
91776540|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.123|TWO_SIDED|95.0|-0.011|0.093|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.093|-0.011|0.123
91776541|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.185|||<|0.001|TWO_SIDED|95.0|0.133|0.237|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.237|0.133|<0.001
91708211|NCT05811026|183309404|SUPERIORITY||Median Difference (Net)|-0.94||||0.0982|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0982
91776542|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.161|0.266||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.266|0.161|<0.001
91776543|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.209|||<|0.001|TWO_SIDED|95.0|0.157|0.261|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.261|0.157|<0.001
91776544|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.116|0.22||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.220|0.116|<0.001
91776545|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.117|0.219|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.219|0.117|<0.001
91776546|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.274|TWO_SIDED|95.0|-0.023|0.081|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.081|-0.023|0.274
91776547|NCT01054885|183433633|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.357|TWO_SIDED|95.0|-0.027|0.075|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.075|-0.027|0.357
91776548|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.044||||0.095|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.095
91776549|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.008||||0.756|TWO_SIDED|95.0|-0.044|0.06|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.060|-0.044|0.756
91776550|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.048|0.151|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.151|0.048|<0.001
91581800|NCT04101318|183053385|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.725|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.725
91776551|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.091|0.197||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.197|0.091|<0.001
91776552|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.131|||<|0.001|TWO_SIDED|95.0|0.08|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.183|0.080|<0.001
91776553|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.047|0.152||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.152|0.047|<0.001
91776554|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.123|||<|0.001|TWO_SIDED|95.0|0.072|0.174||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.174|0.072|<0.001
91776555|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045||||0.093|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.093
91776556|NCT01054885|183433634|SUPERIORITY_OR_OTHER||Least squares mean difference|0.032||||0.224|TWO_SIDED|95.0|-0.019|0.083|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.083|-0.019|0.224
91708212|NCT05811026|183309405|SUPERIORITY||Median Difference (Net)|-0.5||||0.8541|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.8541
91708213|NCT05811026|183309406|SUPERIORITY||Median Difference (Net)|0.63||||0.0758|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0758
91776557|NCT00804908|183433638|SUPERIORITY_OR_OTHER||||||=|0.071|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.071
91776558|NCT00804908|183433638|SUPERIORITY_OR_OTHER||||||=|0.233|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.233
91776559|NCT01280903|183433646|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91776560|NCT01280903|183433647|SUPERIORITY|||||||0.13||||||p=0.130 for None to very low|Mixed Models Analysis|||||||0.130
91776561|NCT01280903|183433647|SUPERIORITY|||||||0.573||||||p=0.573 for Light|Mixed Models Analysis|||||||0.573
91708214|NCT05811026|183309407|SUPERIORITY||Median Difference (Net)|41.75||||0.066|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.066
91776562|NCT01280903|183433647|SUPERIORITY|||||||0.197||||||p=0.197 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.197
91776563|NCT01280903|183433648|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||||||0.461
91776564|NCT01280903|183433649|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.180
91776565|NCT01280903|183433650|SUPERIORITY|||||||0.258|||||||Mixed Models Analysis|||||||0.258
91776566|NCT01280903|183433651|SUPERIORITY|||||||0.416|||||||Mixed Models Analysis|||||||0.416
91520945|NCT03086330|182916649|OTHER||Treatment difference|-3.81|||<|0.0001|TWO_SIDED|95.0|-4.7|-2.93|||ANCOVA|||The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-2.93|-4.70|<0.0001
91520946|NCT02740049|182916720|SUPERIORITY|||||||0.0002||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0002
91520947|NCT02740049|182916721|SUPERIORITY|||||||0.3994||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or Wilcoxon signed rank test as appropriate.||||0.3994
91520948|NCT02740049|182916722|SUPERIORITY|||||||0.0104||||||P value is the comparison between the IFN/TNF induction group versus VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical difference is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0104
91520949|NCT00330174|182916725|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Drinking outcomes were analyzed using multiple linear regression, controlling for site and baseline drinking level. Drinking and psychiatric symptoms assessed over time were examined using repeated measures (intercept only) mixed linear models (PROC MIXED in SAS). Analyses were performed using SAS statistical software (version 9.2; SAS Institute, Inc., Cary, NC). All tests were two-tailed and p-values less than 0.05 were considered statistically significant.||||0.64
91520950|NCT01032733|182916729|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0|||||ANCOVA|||This trial represented a pilot study, which was designed to demonstrate the feasibility, acceptability, and efficacy of the intervention; therefore, a power analysis was not conducted. The statistical analyses consisted of descriptive and intent-to-treat (ITT) modeling procedures.||||<0.05
91520951|NCT01032733|182916730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|5.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91520952|NCT01032733|182916731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91520953|NCT01032733|182916732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91520954|NCT01032733|182916733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91520955|NCT04570436|182916738|SUPERIORITY||Mean Difference (Final Values)|30.9|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|26.2||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of diazepam, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 = 15"|||26.2|<0.0001
91776567|NCT01280903|183433652|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91776568|NCT01280903|183433653|SUPERIORITY|||||||0.272||||||p=0.272 for None to very low|Mixed Models Analysis|||||||0.272
91776569|NCT01280903|183433653|SUPERIORITY|||||||0.823||||||p=0.823 for Light|Mixed Models Analysis|||||||0.823
91520956|NCT04570436|182916738|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.84||0.3581|ONE_SIDED|95.0||14.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.7||0.3581
91520957|NCT04570436|182916738|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|2.85||0.3051|ONE_SIDED|95.0||14.3|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.3||0.3051
91708215|NCT05811026|183309408|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.6961|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6961
91708216|NCT05811026|183309409|SUPERIORITY||Median Difference (Final Values)|1.0||||0.0067|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0067
91776570|NCT01280903|183433653|SUPERIORITY|||||||0.076||||||p=0.076 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.076
91776571|NCT01280903|183433654|SUPERIORITY|||||||0.561|||||||Mixed Models Analysis|||||||0.561
91776572|NCT01280903|183433655|SUPERIORITY|||||||0.856|||||||Mixed Models Analysis|||||||0.856
91776573|NCT01280903|183433656|SUPERIORITY|||||||0.292|||||||Mixed Models Analysis|||||||0.292
91776574|NCT01280903|183433657|SUPERIORITY|||||||0.396|||||||Mixed Models Analysis|||||||0.396
91776575|NCT01280903|183433658|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
91776576|NCT01280903|183433659|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||||||0.586
91776577|NCT01280903|183433660|SUPERIORITY|||||||0.596|||||||Mixed Models Analysis|||||||0.596
91776578|NCT01280903|183433661|SUPERIORITY|||||||0.639|||||||Mixed Models Analysis|||||||0.639
91776579|NCT01280903|183433662|SUPERIORITY|||||||0.466|||||||Mixed Models Analysis|||||||0.466
91776580|NCT01280903|183433663|SUPERIORITY|||||||0.322||||||p=0.322 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.322
91776581|NCT01280903|183433663|SUPERIORITY|||||||0.979||||||p=0.979 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.979
91776582|NCT01280903|183433664|SUPERIORITY|||||||0.71||||||p=0.710 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.710
91581801|NCT04101318|183053386|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.721
91581802|NCT04101318|183053387|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.753|TWO_SIDED|95.0|-0.38|0.28||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.28|-0.38|0.753
91581803|NCT04101318|183053388|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.331|TWO_SIDED|95.0|-1.43|4.18||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||4.18|-1.43|0.331
91581804|NCT04101318|183053389|SUPERIORITY||Mean Difference (Final Values)|11.68||||0.239|TWO_SIDED|95.0|-7.98|31.34||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||31.34|-7.98|0.239
91581805|NCT04101318|183053390|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.322|TWO_SIDED|95.0|-0.91|0.31||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.31|-0.91|0.322
91776583|NCT01280903|183433664|SUPERIORITY|||||||0.133||||||p=0.133 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.133
91776584|NCT01280903|183433665|SUPERIORITY|||||||0.005||||||p=0.005 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.005
91776585|NCT01280903|183433665|SUPERIORITY|||||||0.948||||||p=0.948 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.948
91776586|NCT01280903|183433665|SUPERIORITY|||||||0.663||||||p=0.663 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.663
91776587|NCT01280903|183433666|SUPERIORITY|||||||0.001||||||p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.001
91520958|NCT04570436|182916738|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|2.83||0.2179|ONE_SIDED|95.0||13.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||13.5||0.2179
91520959|NCT04570436|182916738|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.3||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.3|<0.0001
91581806|NCT04101318|183053391|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.343|TWO_SIDED|95.0|-0.44|0.15||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.15|-0.44|0.343
91581807|NCT04101318|183053392|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.387|TWO_SIDED|95.0|-0.53|0.21||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.21|-0.53|0.387
91646365|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.8165|TWO_SIDED|95.0|0.2|3.61|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.61|0.20|0.8165
91708217|NCT02870205|183309411|SUPERIORITY||||||<|0.001||||||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|ANCOVA|||||||<0.001
91776588|NCT01280903|183433666|SUPERIORITY|||||||0.031||||||p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension|Mixed Models Analysis|||||||0.031
91776589|NCT01280903|183433667|SUPERIORITY|||||||0.816|||||||Mixed Models Analysis|||||||0.816
91776590|NCT01280903|183433668|SUPERIORITY|||||||0.895|||||||Mixed Models Analysis|||||||0.895
91776591|NCT01280903|183433669|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||0.260
91776592|NCT01280903|183433670|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
91776593|NCT01280903|183433671|SUPERIORITY|||||||0.947|||||||Mixed Models Analysis|||||||0.947
91776594|NCT01280903|183433672|SUPERIORITY|||||||0.406||||||p=0.406 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.406
91776595|NCT01280903|183433672|SUPERIORITY|||||||0.826||||||p=0.826 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.826
91776596|NCT01280903|183433673|SUPERIORITY|||||||0.95||||||p=0.950 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.950
91776597|NCT01280903|183433673|SUPERIORITY|||||||0.365||||||p=0.365 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.365
91776598|NCT01280903|183433674|SUPERIORITY|||||||0.219||||||p=0.219 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.219
91776599|NCT01280903|183433674|SUPERIORITY|||||||0.34||||||p=0.340 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.340
91776600|NCT01280903|183433674|SUPERIORITY|||||||0.806||||||p=0.806 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.806
91776601|NCT01280903|183433675|SUPERIORITY|||||||0.008||||||p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.008
91581808|NCT04101318|183053393|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.899|TWO_SIDED|95.0|-0.18|0.16||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.16|-0.18|0.899
91581809|NCT00717067|183053394|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|129.17||||||90.0|92.16|181.04|||ANOVA|||Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||181.04|92.16|
91581810|NCT00717067|183053394|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|88.31||||||90.0|61.97|125.83|||ANOVA|||Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||125.83|61.97|
91581811|NCT00717067|183053394|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|322.23||||||90.0|171.97|603.78|||ANOVA|||Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||603.78|171.97|
91708218|NCT02870205|183309411|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
91581812|NCT00717067|183053395|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|151.99||||||90.0|109.53|210.92|||ANOVA|||Ratio (%) test (mild) / reference (normal).||210.92|109.53|
91708219|NCT02870205|183309411|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
91708220|NCT02870205|183309411|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91708221|NCT02870205|183309411|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91708222|NCT01156051|183309442|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.005
91708223|NCT01156051|183309443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Null hypothesis: no difference in ADHD Rating Scales - IV total scores from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||<0.001
91708224|NCT01156051|183309444|SUPERIORITY_OR_OTHER|||||||0.392|||||||ANOVA|||Null hypothesis: no difference in latency to persistent sleep (LPS) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.392
91708225|NCT01156051|183309445|SUPERIORITY_OR_OTHER|||||||0.059|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.059
91708226|NCT02179749|183309465|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED||||||ANOVA|||||||0.51
91708227|NCT02179749|183309465|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.038|TWO_SIDED||||||Mixed Models Analysis|||Latent growth model includes one week on study drug and two weeks after the last dose of study drug. Principal predictors were drug plasma concentration and baseline treatment goal of abstinence or non abstinence. Arms were combined for this analysis.||||0.038
91708228|NCT02179749|183309466|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|36.7||0.5|TWO_SIDED||||||ANOVA|411 and 102 degrees of freedom||||||0.50
91708229|NCT02620384|183309467|SUPERIORITY||Mean Difference (Final Values)|2439.511|STANDARD_ERROR_OF_MEAN|646.2707|<|0.0001|TWO_SIDED|95.0|1160.8485|3718.1734|||t-test, 2 sided|||||3718.1734|1160.8485|<0.0001
91708230|NCT02620384|183309468|SUPERIORITY||Mean Difference (Final Values)|-2249.3294|STANDARD_ERROR_OF_MEAN|608.2782|<|0.0001|TWO_SIDED|95.0|-3454.4999|-1044.1589|||t-test, 2 sided|||||-1044.1589|-3454.4999|<0.0001
91708231|NCT02620384|183309469|SUPERIORITY||Mean Difference (Final Values)|-2.717121|STANDARD_ERROR_OF_MEAN|0.586647|<|0.0001|TWO_SIDED|95.0|-3.8637732|-1.54651|||t-test, 2 sided|||||-1.546510|-3.8637732|<0.0001
91708232|NCT02620384|183309470|SUPERIORITY||Mean Difference (Final Values)|-0.6955|STANDARD_ERROR_OF_MEAN|0.2806||0.014|TWO_SIDED|95.0|-1.2506|-0.1403||Represents BORG\_48\_hours|t-test, 2 sided||Method of estimation is for 48 hour measure.|||-.1403|-1.2506|.014
91708233|NCT02620384|183309471|SUPERIORITY||Mean Difference (Final Values)|3.6903|STANDARD_ERROR_OF_MEAN|72.4074||0.959|TWO_SIDED|95.0|-1395694.0|147.1545|||t-test, 2 sided|||||147.1545|-1395694|.959
91708234|NCT02620384|183309472|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||.144
91708235|NCT02620384|183309473|SUPERIORITY|||||||0.171|||||||Chi-squared|||||||.171
91708236|NCT02620384|183309474|SUPERIORITY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.734||0.885|TWO_SIDED|95.0|-1.346|1.558|||t-test, 2 sided|||||1.558|-1.346|.885
91708237|NCT02620384|183309475|SUPERIORITY|||||||0.804|||||||Chi-squared|||||||.804
91708238|NCT02620384|183309476|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
91708239|NCT02620384|183309477|SUPERIORITY|||||||0.08|||||||Chi-squared|||||||.080
91708240|NCT02620384|183309478|SUPERIORITY|||||||0.559|||||||Chi-squared|||||||.559
91708241|NCT00094536|183309479|SUPERIORITY_OR_OTHER|||||||0.271|||||||1-sided z-test|1-sided z-test with continuity correction (pooled)||||||.271
91708242|NCT02526160|183309492|SUPERIORITY||||||<|0.0001||||||From Cochran-Mantel-Haenszel (CMH) testing for association between achieving mean serum phosphorus levels above lower limit of normal (LLN) and treatment group, adjusting for stratification of Brief Pain Inventory (BPI) Average Pain and region.|Cochran-Mantel-Haenszel|||||||< 0.0001
91708243|NCT02526160|183309493|SUPERIORITY||Least squares (LS) mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.275||0.0919|TWO_SIDED|95.0|-1.0|0.08||Prespecified significance level for test after Hochberg adjustment: 0.05|GEE model|||||0.08|-1.00|0.0919
91708244|NCT02526160|183309494|SUPERIORITY||LS mean difference|-8.31|STANDARD_ERROR_OF_MEAN|3.251||0.0106|TWO_SIDED|95.0|-14.68|-1.94||Prespecified significance level for test after Hochberg adjustment: 0.0167|GEE model|||||-1.94|-14.68|0.0106
91708245|NCT02526160|183309495|SUPERIORITY||LS mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.479||0.0478|TWO_SIDED|95.0|-9.76|-0.05||Prespecified significance level for test after Hochberg adjustment: 0.025|GEE model|||||-0.05|-9.76|0.0478
91708246|NCT03252145|183309564|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
91708247|NCT03252145|183309565|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
91708248|NCT03252145|183309566|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
91708249|NCT03252145|183309567|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
91776602|NCT01280903|183433675|SUPERIORITY|||||||0.12||||||p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension|t-test, 1 sided|||||||0.120
91581813|NCT00717067|183053395|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|115.95||||||90.0|82.23|163.5|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||163.50|82.23|
91581814|NCT00717067|183053396|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|121.01||||||90.0|83.15|176.13|||ANOVA|||Ratio (%) test (mild) / reference (normal).||176.13|83.15|
91581815|NCT00717067|183053396|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|70.9||||||90.0|47.83|105.1|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||105.10|47.83|
91581816|NCT00717067|183053396|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|238.73||||||90.0|106.83|533.48|||ANOVA|||Ratio (%) test (severe) / reference (normal).||533.48|106.83|
91581817|NCT00717067|183053398|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|323.91||||||90.0|174.32|601.88|||ANOVA|||Ratio (%) test (severe) / reference (normal).||601.88|174.32|
91581818|NCT00522873|183053426|SUPERIORITY_OR_OTHER||proportion|0.0|||||TWO_SIDED|95.0|0.0|0.0119|||||The number of women who had a biopsy classified as 'hyperplasia or worse' was divided by the number of women with an evaluable biopsy (i.e. classified as 'normal' after 1 year of treatment or as 'hyperplasia or worse' at any time during the study).|Exact 95% confidence interval for proportion of participants with hyperplasia or worse at EoS||0.0119|0.0000|
91581819|NCT00522873|183053427|SUPERIORITY_OR_OTHER||proportion|0.687|||||TWO_SIDED|95.0|0.637|0.734||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.734|0.637|
91708250|NCT03252145|183309568|OTHER|||||||0.552|||||||t-test, 2 sided|||||||0.552
91776603|NCT03829228|183433676|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.62|2.01||The threshold for statistical significance was p=0.01|ANOVA||Treatment Difference= Visit5-Baseline|||2.01|0.62|<0.0001
91776604|NCT03829228|183433677|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.01|Regression, Logistic|||||||<0.0001
91581820|NCT00522873|183053427|SUPERIORITY_OR_OTHER||proportion|0.593|||||TWO_SIDED|95.0|0.496|0.684||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.684|0.496|
91581821|NCT00522873|183053428|SUPERIORITY_OR_OTHER||proportion|0.789|||||TWO_SIDED|95.0|0.743|0.83||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.830|0.743|
91581822|NCT00522873|183053428|SUPERIORITY_OR_OTHER||proportion|0.84|||||TWO_SIDED|95.0|0.756|0.904||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.904|0.756|
91581823|NCT00822172|183053436|SUPERIORITY|||||||0.076|||||||two-sample equal-variances t-test|||||||0.076
91776605|NCT03829228|183433678|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.64|1.98||The threshold for statistical significance was p=0.01|ANOVA||Treatment difference=Visit5-Baseline|||1.98|0.64|<0.0001
91776606|NCT03829228|183433679|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significant was p=0.01.|Regression, Logistic|||||||<0.0001
91581824|NCT00822172|183053437|SUPERIORITY|||||||0.048|||||||two-sample equal-variances t-test|||||||0.048
91581825|NCT00822172|183053438|SUPERIORITY|||||||0.65|||||||two-sample equal-variances t-test|||||||0.650
91581826|NCT00545051|183053455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25|||<|0.001|TWO_SIDED|95.0|2.09|4.41|||ANCOVA|||||4.41|2.09|<0.001
91581827|NCT00545051|183053456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.22|3.23|||ANCOVA|||||3.23|1.22|<0.001
91581828|NCT00545051|183053457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.122|TWO_SIDED|95.0|-0.15|1.25|||ANCOVA|||Month 6||1.25|-0.15|0.122
91581829|NCT00545051|183053457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|0.96|2.66|||ANCOVA|||Month 12||2.66|0.96|<0.001
91581830|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 1||||<0.001
91581831|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 6||||<0.001
91581832|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 12||||<0.001
91581833|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 1||||<0.001
91581834|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 6||||<0.001
91581835|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 12||||<0.001
91581836|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 1||||<0.001
91581837|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 6||||<0.001
91581838|NCT00545051|183053458|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 12||||<0.001
91581839|NCT01375114|183053460|OTHER|||||||0.67|||||||Chi-squared|||||||0.67
91581840|NCT01375114|183053461|OTHER|||||||0.71|||||||Chi-squared|||||||0.71
91581841|NCT01375114|183053462|OTHER|||||||0.34|||||||Chi-squared|||||||0.34
91581842|NCT01375114|183053463|OTHER|||||||0.36|||||||Chi-squared|||||||0.36
91581843|NCT01375114|183053464|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
91613901|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
91613902|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
91708251|NCT03252145|183309569|OTHER|||||||0.498|||||||t-test, 2 sided|||||||0.498
91776607|NCT02177695|183433680|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1|TWO_SIDED|95.0|0.82|8.36|||Regression, Logistic|||To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.||8.36|0.82|0.1
91776608|NCT02177695|183433680|SUPERIORITY||Odds Ratio (OR)|1.12||||0.82|TWO_SIDED|95.0|0.42|2.95|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.||2.95|0.42|0.82
91776609|NCT02177695|183433681|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.11|4.89|||Regression, Logistic|||To determine the relationship of GC COXEN scores to \<= pT1, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the GC treatment group.||4.89|1.11|0.02
91581844|NCT00477334|183053465|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.26||||0.4161|TWO_SIDED|95.0|-0.4|0.98|||Hodges-Lehman Shift Model||Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)||0.98|-0.40|0.4161
91581845|NCT00477334|183053465|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.9372|TWO_SIDED|95.0|0.74|1.39|||Kaplan-Meier & Cox Regression||"Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.~Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables."|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.||1.39|0.74|0.9372
91581846|NCT00952120|183053473|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Logistic|robust standard errors were used to account for the multiple observations per patient||||||0.80
91581847|NCT04745026|183053475|SUPERIORITY||Least square mean difference|3.37|STANDARD_ERROR_OF_MEAN|1.931|=|0.085|TWO_SIDED|95.0|-0.48|7.21||Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).|Mixed models for repeated measures|||Irritability (Week 12)||7.21|-0.48|=0.085
91581848|NCT04745026|183053475|SUPERIORITY||Least square mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.16|=|0.3107|TWO_SIDED|95.0|-1.08|3.36|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Social Withdrawal Week 12)||3.36|-1.08|=0.3107
91581849|NCT04745026|183053475|SUPERIORITY||Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.695|=|0.9513|TWO_SIDED|95.0|-1.34|1.42|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Stereotypic Behavior (Week 12)||1.42|-1.34|=0.9513
91708252|NCT03252145|183309570|OTHER|||||||0.264|||||||t-test, 2 sided|||Affected Arm Only||||0.264
91776610|NCT02177695|183433681|SUPERIORITY||Odds Ratio (OR)|0.9||||0.76|TWO_SIDED|95.0|0.46|1.75|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to \<=pT1, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the ddMVAC treatment group.||1.75|0.46|0.76
91776611|NCT02844569|183433688|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91581850|NCT04745026|183053475|SUPERIORITY||Least square mean difference|2.01|STANDARD_ERROR_OF_MEAN|1.943|=|0.305|TWO_SIDED|95.0|-1.86|5.88|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Hyperactivity/Noncompliance (Week 12)||5.88|-1.86|=0.305
91581851|NCT04745026|183053475|SUPERIORITY||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.517|=|0.4754|TWO_SIDED|95.0|-1.4|0.66|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Inappropriate Speech (Week 12)||0.66|-1.4|=0.4754
91581852|NCT04745026|183053476|SUPERIORITY||Least square mean difference|0.45|STANDARD_ERROR_OF_MEAN|2.36|=|0.8506|TWO_SIDED|95.0|-4.26|5.15|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Week 12||5.15|-4.26|=0.8506
91708253|NCT03252145|183309570|OTHER|||||||0.224|||||||t-test, 2 sided|||Unaffected arm||||0.224
91708254|NCT03252145|183309571|OTHER|||||||0.125|||||||t-test, 2 sided|||Affected arm||||0.125
91708255|NCT03252145|183309571|OTHER|||||||0.241|||||||t-test, 2 sided|||Unaffected arm||||0.241
91708256|NCT03252145|183309572|OTHER|||||||0.261|||||||t-test, 2 sided|||Affected Arm||||0.261
91708257|NCT03252145|183309572|OTHER|||||||0.597|||||||t-test, 2 sided|||Unaffected Arm||||0.597
91776612|NCT02844569|183433689|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91708258|NCT03252145|183309573|OTHER|||||||0.596|||||||t-test, 2 sided|||Affected arm||||0.596
91708259|NCT03252145|183309573|OTHER|||||||0.219|||||||t-test, 2 sided|||Unaffected arm||||0.219
91708260|NCT03252145|183309574|OTHER|||||||0.842|||||||t-test, 2 sided|||||||0.842
91708261|NCT03252145|183309575|OTHER|||||||0.772|||||||t-test, 2 sided|||||||0.772
91708262|NCT03252145|183309576|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
91776613|NCT02844569|183433690|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91776614|NCT00744497|183433691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9009|TWO_SIDED|95.53|0.87|1.13||An interim analysis on survival was performed and the final test was corrected for multiplicity.|Log Rank|||Confidence intervals for median overall survival calculated using Brookmeyer and Crowley method. Compared survival in arms by 2-sided, alpha=0.0447 level, log-rank test, stratified by bisphosphonate intake (yes/no) and urinary N-telopeptide category (\<60 vs ≥60 nmol/mmol creatinine) defined at randomization. Null hypothesis was survival equal in both arms. Power calculations were that ≥858 deaths would lead to ≥90% power at 5% level for rejecting null hypothesis, given true hazard ratio of 0.8.||1.13|0.87|0.9009
91776615|NCT00744497|183433692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.935|||||TWO_SIDED|95.0|0.688|1.271||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.271|0.688|
91708263|NCT03252145|183309577|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
91520960|NCT04570436|182916738|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|21.4|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.7||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.7|<0.0001
91520961|NCT04570436|182916738|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|17.4||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||17.4|<0.0001
91520962|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|325.8|STANDARD_ERROR_OF_MEAN|113.38||0.0023|ONE_SIDED|90.0|138.2||||Mixed Models Analysis||||||138.2|0.0023
91520963|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|140.5|STANDARD_ERROR_OF_MEAN|113.01||0.2157|TWO_SIDED|90.0|-82.7|363.7|||Mixed Models Analysis|||||363.7|-82.7|0.2157
91520964|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|155.4|STANDARD_ERROR_OF_MEAN|113.25||0.172|TWO_SIDED|90.0|-68.3|379.1|||Mixed Models Analysis|||||379.1|-68.3|0.1720
91520965|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|212.2|STANDARD_ERROR_OF_MEAN|113.01||0.0622|TWO_SIDED|90.0|-11.0|435.5|||Mixed Models Analysis|||||435.5|-11.0|0.0622
91520966|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|-185.0|STANDARD_ERROR_OF_MEAN|113.04||0.1031|TWO_SIDED|90.0|-409.0|37.94|||Mixed Models Analysis|||||37.94|-409|0.1031
91520967|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|-170.0|STANDARD_ERROR_OF_MEAN|112.97||0.1334|TWO_SIDED|90.0|-394.0|52.71|||Mixed Models Analysis|||||52.71|-394|0.1334
91520968|NCT04570436|182916740|OTHER||Mean Difference (Final Values)|-114.0|STANDARD_ERROR_OF_MEAN|113.59||0.3189|TWO_SIDED|90.0|-338.0|110.8|||Mixed Models Analysis|||||110.8|-338|0.3189
91520969|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|55.77|STANDARD_ERROR_OF_MEAN|5.362|<|0.0001|ONE_SIDED|90.0|46.89||||Mixed Models Analysis||||||46.89|<0.0001
91520970|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|17.18|STANDARD_ERROR_OF_MEAN|5.348||0.0016|TWO_SIDED|90.0|6.61|27.74|||Mixed Models Analysis|||||27.74|6.61|0.0016
91520971|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|21.38|STANDARD_ERROR_OF_MEAN|5.36||0.0001|TWO_SIDED|90.0|10.79|31.96|||Mixed Models Analysis|||||31.96|10.79|0.0001
91520972|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.352|<|0.0001|TWO_SIDED|90.0|11.92|33.07|||Mixed Models Analysis|||||33.07|11.92|<0.0001
91520973|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|-38.6|STANDARD_ERROR_OF_MEAN|5.312|<|0.0001|TWO_SIDED|90.0|-49.1|-28.1|||Mixed Models Analysis|||||-28.1|-49.1|<0.0001
91520974|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|5.308|<|0.0001|TWO_SIDED|90.0|-44.9|-23.9|||Mixed Models Analysis|||||-23.9|-44.9|<0.0001
91520975|NCT04570436|182916741|OTHER||Mean Difference (Final Values)|-33.3|STANDARD_ERROR_OF_MEAN|5.337|<|0.0001|TWO_SIDED|90.0|-43.8|-22.7|||Mixed Models Analysis|||||-22.7|-43.8|<0.0001
91520976|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|234.9|STANDARD_ERROR_OF_MEAN|38.174|<|0.0001|ONE_SIDED|90.0|171.7||||Mixed Models Analysis||||||171.7|<0.0001
91520977|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|66.3|STANDARD_ERROR_OF_MEAN|38.048||0.0834|TWO_SIDED|90.0|-8.86|141.5|||Mixed Models Analysis|||||141.5|-8.86|0.0834
91520978|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|99.06|STANDARD_ERROR_OF_MEAN|38.128||0.0103|TWO_SIDED|90.0|23.75|174.4|||Mixed Models Analysis|||||174.4|23.75|0.0103
91520979|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|97.2|STANDARD_ERROR_OF_MEAN|38.048||0.0116|TWO_SIDED|90.0|22.05|172.4|||Mixed Models Analysis|||||172.4|22.05|0.0116
91520980|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|-169.0|STANDARD_ERROR_OF_MEAN|38.06|<|0.0001|TWO_SIDED|90.0|-244.0|-93.4|||Mixed Models Analysis|||||-93.4|-244|<0.0001
91520981|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|-136.0|STANDARD_ERROR_OF_MEAN|38.036||0.0005|TWO_SIDED|90.0|-211.0|-60.7|||Mixed Models Analysis|||||-60.7|-211|0.0005
91520982|NCT04570436|182916743|OTHER||Mean Difference (Final Values)|-138.0|STANDARD_ERROR_OF_MEAN|38.243||0.0004|TWO_SIDED|90.0|-213.0|-62.2|||Mixed Models Analysis|||||-62.2|-213|0.0004
91520983|NCT03088267|182916782|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.0118|TWO_SIDED|95.0|-14.94|-2.17|||ANCOVA|||||-2.17|-14.94|0.0118
91520984|NCT03088267|182916783|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.1128|TWO_SIDED|95.0|-4.94|42.5|||ANCOVA|||Comparison at 30 minutes post-dose||42.50|-4.94|0.1128
91520985|NCT03088267|182916783|SUPERIORITY||Mean Difference (Final Values)|60.3||||0.0003|TWO_SIDED|95.0|32.91|87.75|||ANCOVA|||Comparison at 3 hours postdose||87.75|32.91|0.0003
91520986|NCT02279043|182916789|SUPERIORITY||Odds Ratio (OR)|0.88||||0.89|TWO_SIDED|95.0|0.16|4.88|||Regression, Logistic|||||4.88|0.16|0.89
91520987|NCT02279043|182916790|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
91520988|NCT02279043|182916791|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91520989|NCT02279043|182916791|SUPERIORITY||Slope|0.59||||0.02|TWO_SIDED|95.0|0.08|1.11|||Regression, Linear|||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.11|0.08|0.02
91520990|NCT02279043|182916792|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91520991|NCT02279043|182916793|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91520992|NCT02279043|182916794|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.75|2.2|||Regression, Logistic|||||2.20|0.75|0.34
91520993|NCT02279043|182916795|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.49|2.05|||Regression, Logistic|||||2.05|0.49|0.99
91520994|NCT02279043|182916796|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||||2.29|0.95|0.08
91520995|NCT02279043|182916797|SUPERIORITY||Odds Ratio (OR)|1.63||||0.03|TWO_SIDED|95.0|1.05|2.58|||Regression, Logistic|||||2.58|1.05|0.03
91708264|NCT03252145|183309578|OTHER|||||||0.679|||||||t-test, 2 sided|||||||0.679
91708265|NCT03252145|183309579|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.120
91708266|NCT03252145|183309580|OTHER|||||||0.138|||||||t-test, 2 sided|||||||0.138
91708267|NCT03252145|183309581|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
91708268|NCT03252145|183309582|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
91708269|NCT03252145|183309584|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
91776616|NCT00744497|183433693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.02|0.64|
91776617|NCT00744497|183433694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.93|1.763||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.763|0.930|
91776618|NCT00744497|183433695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.82|1.05||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.05|0.82|
91776619|NCT00744497|183433696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.79|1.01||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.01|0.79|
91776620|NCT00744497|183433697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791|||||TWO_SIDED|95.0|0.594|1.052||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for of experimental to control group.||1.052|0.594|
91776621|NCT02443688|183433706|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% confidence interval (CI)|Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|95.0|-1.34|4.12|||ANOVA|||||4.12|-1.34|
91776622|NCT02443688|183433706|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% CI|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-3.78|1.64|||ANOVA|||||1.64|-3.78|
91776623|NCT02443688|183433706|SUPERIORITY|Difference from placebo of pooled arms (100mg CTX-4430 and 50mg CTX-4430) in change from baseline in ppFEV1 at Week 48.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-2.2|2.5||0.1 alpha level (2-sided) prespecified|ANOVA|||||2.50|-2.20|0.45
91776624|NCT02443688|183433707|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.57|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.22|2.02|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.02|1.22|
91708270|NCT03252145|183309585|OTHER|||||||0.068|||||||t-test, 2 sided|||Physical Function Domain||||0.068
91776625|NCT02443688|183433707|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.46|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|1.13|1.89|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.89|1.13|
91776626|NCT02443688|183433707|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.56|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.21|2.01|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.01|1.21|
91776627|NCT02443688|183433707|OTHER|Pooled Group Rate with 95% CI|see Estimation Comment below|1.51|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|1.26|1.81|||||Estimated using negative binomial distribution unadjusted for multiple comparisons.|||1.81|1.26|
91776628|NCT02443688|183433708|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.88|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.58|1.34|||Regression, Cox|||||1.34|0.58|
91776629|NCT02443688|183433708|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.56|1.31|||Regression, Cox|||||1.31|0.56|
91776630|NCT02443688|183433708|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.61|1.25|||Regression, Cox|||||1.25|0.61|
91776631|NCT02443688|183433714|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|0.84|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.49|1.44|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.44|0.49|
91776632|NCT02443688|183433714|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.28|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|0.84|1.96|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.96|0.84|
91776633|NCT02443688|183433714|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|1.07|2.42|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.42|1.07|
91776634|NCT02443688|183433714|OTHER|Group Rate with 95% CI|see Estimation Comment below|1.04|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.74|1.46|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.46|0.74|
91776635|NCT02443688|183433715|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|0.25|1.1|||Regression, Cox|||||1.10|0.25|
91776636|NCT02443688|183433715|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.3|1.27|||Regression, Cox|||||1.27|0.30|
91776637|NCT02443688|183433715|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.57|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.31|1.05|||Regression, Cox|||||1.05|0.31|
91776638|NCT00989911|183433732|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91776639|NCT00837434|183433733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED||||||ANCOVA|P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory||Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.||||0.3
91776640|NCT03044106|183433743|SUPERIORITY||Mean Difference (Final Values)|3.825|STANDARD_DEVIATION|3.308759||0.0068|TWO_SIDED|95.0|1.058809|6.591192|||t-test, 2 sided|||This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.||6.591192|1.058809|0.0068
91776641|NCT03044106|183433743|SUPERIORITY||Median Difference (Final Values)|1.0|STANDARD_DEVIATION|3.431784||0.2185|TWO_SIDED|95.0|-1.869044|3.869044|||t-test, 2 sided|||This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.||3.869044|-1.869044|0.2185
91776642|NCT03044106|183433743|SUPERIORITY||Mean Difference (Final Values)|0.6638904|STANDARD_DEVIATION|3.450892||0.1281|TWO_SIDED|95.0|-0.5037233|1.831504|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.||1.831504|-.5037233|0.1281
91776643|NCT03044106|183433743|SUPERIORITY||Mean Difference (Final Values)|2.688237|STANDARD_DEVIATION|3.241751||0|TWO_SIDED|95.0|1.557137|3.819337|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.||3.819337|1.557137|0.00
91776644|NCT03044106|183433743|SUPERIORITY||Mean Difference (Final Values)|2.825||||0.09|TWO_SIDED|95.0|-0.4543|6.0581|||Mixed Models Analysis|||This is the mean difference in effect between active and sham in those with a history of hamstring strain||6.0581|-0.4543|0.090
91776645|NCT03044106|183433743|SUPERIORITY||Mean Difference (Final Values)|-2.024||||0.018|TWO_SIDED|95.0|-3.4474|-0.3406|||Mixed Models Analysis|||This is the mean difference of effect between active and sham in those without a history of hamstring strain.||-0.3406|-3.4474|0.018
91581853|NCT04745026|183053477|SUPERIORITY||Odds Ratio (OR)|1.22|||=|0.7087|TWO_SIDED|95.0|0.43|3.51|||Regression, Logistic|Includes treatment arm, randomization variables and baseline score (CGI-S) covariates. Responders achieved a score of 1 or 2 at post-baseline visits.||Responders with 'Very Much Improved' or 'Much Improved' response at week 12||3.51|0.43|=0.7087
91776646|NCT03199976|183433763|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
91776647|NCT03199976|183433764|SUPERIORITY|||||||0.595|||||||Chi-squared|||||||0.595
91776648|NCT03199976|183433765|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
91776649|NCT03199976|183433766|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91776650|NCT03367793|183433767|OTHER||f statistic|1.1||||0.341|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.341
91776651|NCT03367793|183433767|OTHER||least square means|0.31|||||TWO_SIDED|95.0|0.26|0.36|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.36|0.26|
91776652|NCT03367793|183433767|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.27|0.38|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.38|0.27|
91776653|NCT03367793|183433767|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.39|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.39|0.28|
91776654|NCT03367793|183433768|OTHER||f statistic|0.93||||0.41|TWO_SIDED|||||The threshold for statistical significance was 0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.410
91776655|NCT03367793|183433768|OTHER||least square means|0.35|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.41|0.28|
91776656|NCT03367793|183433768|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.26|0.39|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.39|0.26|
91776657|NCT03367793|183433768|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.41|0.28|
91776658|NCT03367793|183433769|OTHER||f statistic|1.09||||0.351|TWO_SIDED|||||The threshold for statistical significance was alpha=0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.351
91776659|NCT03367793|183433769|OTHER||least square means|11.0|||||TWO_SIDED|95.0|9.3|12.7|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST.|||12.7|9.3|
91776660|NCT03367793|183433769|OTHER||least square means|10.9|||||TWO_SIDED|95.0|9.2|12.6|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX.|||12.6|9.2|
91776661|NCT03367793|183433769|OTHER||least square means|11.2|||||TWO_SIDED|95.0|9.5|12.9|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction.|||12.9|9.5|
91776662|NCT03367793|183433770|OTHER||f statistic|0.58||||0.562|TWO_SIDED||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||0.562
91776663|NCT03367793|183433770|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST.|||||
91776664|NCT03367793|183433770|OTHER||proportion|0.933|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX.|||||
91776665|NCT03367793|183433770|OTHER||proportion|0.897|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction.|||||
91776666|NCT03367793|183433771|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
91581854|NCT04745026|183053478|SUPERIORITY||||||=|0.6108|||||||Cochran-Mantel-Haenszel|||Week 12||||=0.6108
91581855|NCT01415531|183053493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.7|-4.8|||ANCOVA|||||-4.8|-7.7|<0.0001
91708271|NCT03252145|183309585|OTHER|||||||0.808|||||||t-test, 2 sided|||Anxiety Domain||||0.808
91581856|NCT00122460|183053495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.036|TWO_SIDED|95.0|0.644|0.986|||Stratified Log Rank|||"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) \[no vs. yes\] and Karnofsky Performance Status (KPS) \[\<80 vs. ≥80\]).~Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.986|0.644|0.036
91581857|NCT00122460|183053496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538|||<|0.0001|TWO_SIDED|95.0|0.431|0.672|||Stratified Log Rank|||"To test the equality of PFS between treatment groups, a two-sided stratified log-rank test (α=5%)was used, taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median PFS time was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.672|0.431|<0.0001
91581858|NCT00122460|183053497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.326||||0.0001|TWO_SIDED|95.0|1.504|3.6|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||3.600|1.504|0.0001
91708272|NCT03252145|183309585|OTHER|||||||0.557|||||||t-test, 2 sided|||Depression Domain||||0.557
91708273|NCT03252145|183309585|OTHER|||||||0.049|||||||t-test, 2 sided|||Fatigue Domain||||0.049
91708274|NCT03252145|183309585|OTHER|||||||0.279|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.279
91708275|NCT03252145|183309585|OTHER|||||||0.02|||||||t-test, 2 sided|||Roles/Activity Domain||||0.020
91708276|NCT03252145|183309585|OTHER|||||||0.009|||||||t-test, 2 sided|||Pain Interference Domain||||0.009
91708277|NCT03252145|183309586|OTHER|||||||0.038|||||||t-test, 2 sided|||Physical Function Domain||||0.038
91708278|NCT03252145|183309586|OTHER|||||||0.108|||||||t-test, 2 sided|||Anxiety Domain||||0.108
91776667|NCT03367793|183433771|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST.|||||
91776668|NCT03367793|183433771|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX.|||||
91776669|NCT03367793|183433771|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction.|||||
91776670|NCT03367793|183433772|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
91776671|NCT03367793|183433772|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST.|||||
91776672|NCT03367793|183433772|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX.|||||
91776673|NCT03367793|183433772|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction.|||||
91776674|NCT04218240|183433783|SUPERIORITY|||||||0.05|||||||Chi-squared|1 degree of freedom||A nonparametric (Kruskal-Wallis) comparison of the two groups (p=0.049)||||.05
91776675|NCT04218240|183433784|OTHER|Chi-square analysis||||||0.27|||||||Chi-squared|||hypothesis: more people in active PGB/LFX will complete withdrawal CI = 95% P = 0.5||||0.27
91776676|NCT00135226|183433803|OTHER||Rate Ratio|0.88||||0.01|TWO_SIDED|95.0|0.79|0.97|||Log Rank|||||0.97|0.79|0.01
91776677|NCT00135226|183433803|OTHER||Rate Ratio|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08|||Log Rank|||||1.08|0.87|0.55
91776678|NCT00135226|183433804|OTHER||Rate Ratio|1.29||||0.003|TWO_SIDED|95.0|1.09|1.52|||Log Rank|||||1.52|1.09|0.003
91776679|NCT00135226|183433805|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
91776680|NCT00135226|183433805|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.09||||||||1.09|0.91|
91776681|NCT00135226|183433806|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||||1.24|0.80|
91776682|NCT00135226|183433807|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.04||||||||1.04|0.85|
91776683|NCT00135226|183433807|OTHER||Risk Ratio|0.95|||||TWO_SIDED|95.0|0.86|1.05||||||||1.05|0.86|
91776684|NCT00135226|183433808|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||||1.12|0.66|
91776685|NCT00135226|183433808|OTHER||Rate ratio|0.79|||||TWO_SIDED|95.0|0.61|1.02||||||||1.02|0.61|
91776686|NCT00135226|183433809|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|0.7|1.77||||||||1.77|0.7|
91776687|NCT00135226|183433809|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5||||||||1.50|0.59|
91776688|NCT00135226|183433810|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.68|1.34||||||||1.34|0.68|
91776689|NCT00135226|183433810|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.12||||||||1.12|0.57|
91776690|NCT00135226|183433811|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15||||||||1.15|0.84|
91776691|NCT00135226|183433811|OTHER||Rate ratio|0.95|||||TWO_SIDED|95.0|0.82|1.12||||||||1.12|0.82|
91776692|NCT00135226|183433812|OTHER||Rate ratio|1.19|||||TWO_SIDED|95.0|0.86|1.63||||||||1.63|0.86|
91776693|NCT00135226|183433812|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
91520996|NCT02279043|182916797|SUPERIORITY||Slope|0.5||||0.03|TWO_SIDED|95.0|0.04|0.97|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||0.97|0.04|0.03
91520997|NCT02279043|182916798|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.01|TWO_SIDED|95.0|1.42|3.56|||Regression, Logistic|||||3.56|1.42|<0.01
91776694|NCT00135226|183433813|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.01||||||||1.01|0.64|
91776695|NCT00135226|183433813|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.0|1.59||||||||1.59|1.00|
91776696|NCT00135226|183433814|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.46|1.6||||||||1.60|0.46|
91776697|NCT00135226|183433814|OTHER||Rate ratio|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
91776698|NCT00135226|183433815|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.3||||||||3.30|0.17|
91776699|NCT00135226|183433815|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.31||||||||3.31|0.17|
91776700|NCT00135226|183433816|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
91776701|NCT00135226|183433816|OTHER||Risk Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.10|0.91|
91776702|NCT00135226|183433817|OTHER||Rate Ratio|1.06|||||TWO_SIDED|95.0|0.78|1.43||||||||1.43|0.78|
91776703|NCT00135226|183433818|OTHER||Rate ratio|0.98|||||TWO_SIDED|95.0|0.74|1.29||||||||1.29|0.74|
91776704|NCT00135226|183433818|OTHER||Rate Ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||||1.37|0.79|
91776705|NCT00135226|183433819|OTHER||Rate Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.32||||||||1.32|0.97|
91776706|NCT00135226|183433819|OTHER||Rate Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||||1.25|0.91|
91776707|NCT00135226|183433820|OTHER||Rate Ratio|1.02|||||TWO_SIDED|95.0|0.76|1.38||||||||1.38|0.76|
91776708|NCT00135226|183433820|OTHER||Rate Ratio|1.17|||||TWO_SIDED|95.0|0.87|1.58||||||||1.58|0.87|
91776709|NCT00135226|183433821|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.76|1.34||||||||1.34|0.76|
91776710|NCT00135226|183433821|OTHER||Rate Ratio|1.14|||||TWO_SIDED|95.0|0.86|1.52||||||||1.52|0.86|
91776711|NCT00135226|183433822|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.58|1.23||||||||1.23|0.58|
91776712|NCT00135226|183433822|OTHER||Rate ratio|1.02|||||TWO_SIDED|95.0|0.7|1.48||||||||1.48|0.70|
91776713|NCT00135226|183433823|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.49|1.41||||||||1.41|0.49|
91776714|NCT00135226|183433823|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.42|1.22||||||||1.22|0.42|
91776715|NCT00135226|183433824|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.5|1.41||||||||1.41|0.50|
91776716|NCT00135226|183433824|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
91776717|NCT00135226|183433825|OTHER||Rate Ratio|1.23|||||TWO_SIDED|95.0|0.98|1.54||||||||1.54|0.98|
91776718|NCT00135226|183433826|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.63|1.12||||||||1.12|0.63|
91776719|NCT02893293|183433854|OTHER|||||||0.002||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.002
91776720|NCT02893293|183433855|OTHER|||||||0.02||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.02
91776721|NCT03279081|183433870|SUPERIORITY||Difference in Combined Remission Rate|2.37|||=|0.571|TWO_SIDED|95.0|-5.82|10.55||P-value was based on stratified Cochran-Mantel-Haenszel (CMH) test adjusting for interactive web response system (IWRS) randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals (CI) are displayed.|||10.55|-5.82|=0.571
91776722|NCT03279081|183433871|SUPERIORITY||Difference in Clinical Remission Rate|2.72|||=|0.515|TWO_SIDED|95.0|-5.47|10.9||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||10.90|-5.47|=0.515
91776723|NCT03279081|183433872|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.374|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate the hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.374
91776724|NCT03279081|183433873|SUPERIORITY||Difference in Combined Remission Rate|1.27|||=|0.757|TWO_SIDED|95.0|-6.77|9.31||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.31|-6.77|=0.757
91776725|NCT03279081|183433874|SUPERIORITY||Difference in Clinical Remission Rate|1.6|||=|0.697|TWO_SIDED|95.0|-6.46|9.66||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.66|-6.46|=0.697
91776726|NCT03279081|183433875|SUPERIORITY||Difference in Clinical Response Rate|3.23|||=|0.428|TWO_SIDED|95.0|-4.76|11.21||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.21|-4.76|=0.428
91776727|NCT03279081|183433876|SUPERIORITY||Difference in Clinical Response Rate|2.84|||=|0.497|TWO_SIDED|95.0|-5.35|11.03||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.03|-5.35|=0.497
91776728|NCT03279081|183433877|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.363|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.363
91776729|NCT03279081|183433878|SUPERIORITY||Hazard Ratio (HR)|0.98|||=|0.833|TWO_SIDED|95.0|0.82|1.18||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.18|0.82|=0.833
91520998|NCT02279043|182916798|SUPERIORITY||Slope|0.84|||<|0.01|TWO_SIDED|95.0|0.33|1.35|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.35|0.33|<0.01
91776730|NCT03279081|183433879|SUPERIORITY||Hazard Ratio (HR)|0.97|||=|0.717|TWO_SIDED|95.0|0.81|1.16||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.16|0.81|=0.717
91776731|NCT03279081|183433880|SUPERIORITY||Difference in Relapse Rate|3.03|||=|0.599|TWO_SIDED|95.0|-8.28|14.34||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||14.34|-8.28|=0.599
91776732|NCT00771914|183433884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from baseline compared to four hours after placebo.||||0.00
91520999|NCT02279043|182916799|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.93
91521000|NCT02279043|182916800|SUPERIORITY||Odds Ratio (OR)|1.19||||0.68|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.68
91521001|NCT02279043|182916801|SUPERIORITY||Odds Ratio (OR)|1.24||||0.33|TWO_SIDED|95.0|0.08|1.93|||Regression, Logistic|||||1.93|0.08|0.33
91521002|NCT00774579|182916804|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
91521003|NCT00774579|182916805|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91521004|NCT02963974|182916811|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.||||< 0.001
91708279|NCT03252145|183309586|OTHER|||||||0.467|||||||t-test, 2 sided|||Depression Domain||||0.467
91581859|NCT00122460|183053498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|1.87|4.441|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||4.441|1.870|<0.0001
91581860|NCT00122460|183053499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.484|0.727|||Stratified Log Rank|||"Treatment groups were compared applying a two-sided stratified log-rank test (α=5%), taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median time to treatment failure was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.727|0.484|<0.0001
91581861|NCT00122460|183053500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.21|TWO_SIDED|95.0|0.497|1.168|||Stratified Log Rank|||"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX \[no vs. yes\] and KPS \[\<80 vs. ≥80\]).~Median duration of response was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||1.168|0.497|0.21
91581862|NCT02084056|183053511|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.68|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|100.703|106.747|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||106.747|100.703|<0.0001
91581863|NCT02084056|183053511|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.63|STANDARD_ERROR_OF_MEAN|1.047||0.0003|TWO_SIDED|90.0|93.721|110.202|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||110.202|93.721|0.0003
91581864|NCT02084056|183053512|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|114.58|STANDARD_ERROR_OF_MEAN|1.038||0.0113|TWO_SIDED|90.0|107.687|121.908|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||121.908|107.687|0.0113
91581865|NCT02084056|183053512|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.28|STANDARD_ERROR_OF_MEAN|1.075||0.0064|TWO_SIDED|90.0|86.543|111.609|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||111.609|86.543|0.0064
91581866|NCT02084056|183053513|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.45|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.23|101.97|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.97|91.23|<0.0001
91581867|NCT02084056|183053513|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.75|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|90.47|105.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||105.63|90.47|0.0002
91581868|NCT02084056|183053514|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.96|STANDARD_ERROR_OF_MEAN|1.038|<|0.0001|TWO_SIDED|90.0|92.046|104.257|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||104.257|92.046|<0.0001
91581869|NCT02084056|183053514|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.85|STANDARD_ERROR_OF_MEAN|1.053||0.003|TWO_SIDED|90.0|96.705|115.861|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||115.861|96.705|0.0030
91581870|NCT02084056|183053515|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|98.426|108.79|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||108.790|98.426|<0.0001
91581871|NCT02084056|183053515|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.35|STANDARD_ERROR_OF_MEAN|1.062||0.0019|TWO_SIDED|90.0|91.13|112.708|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||112.708|91.130|0.0019
91646366|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.6624|TWO_SIDED|95.0|0.17|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.12|0.17|0.6624
91646367|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6316|TWO_SIDED|95.0|0.45|3.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.68|0.45|0.6316
91646368|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.906|TWO_SIDED|95.0|0.35|3.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.22|0.35|0.9060
91646369|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3731|TWO_SIDED|95.0|0.61|3.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.74|0.61|0.3731
91521005|NCT02963974|182916811|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.||||< 0.001
91521006|NCT02963974|182916813|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05. This was a two-way repeated measures ANOVA.|ANOVA|||Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
91521007|NCT02963974|182916814|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
91521008|NCT02963974|182916818|SUPERIORITY|||||||0.01911||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.||||0.01911
91521009|NCT02963974|182916819|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Speech subtest.||||< 0.001
91521010|NCT02963974|182916819|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Spatial subtest.||||0.001
91521011|NCT02963974|182916819|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Qualities subtest.||||< 0.001
91521012|NCT02963974|182916820|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores over time.||||< 0.001
91521013|NCT02963974|182916821|SUPERIORITY|||||||0.1009||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores to evaluation change over time: General Fatigue Subtest||||0.1009
91521014|NCT02963974|182916821|SUPERIORITY|||||||0.109||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Sleep Fatigue Subtest||||0.109
91521015|NCT02963974|182916821|SUPERIORITY|||||||0.1733||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest||||0.1733
91521016|NCT00567190|182916829|SUPERIORITY||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75||Tested at two-sided 5% significance level|Log Rank (stratified)|Stratified by prior treatment status and region|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.75|0.51|<0.0001
91521017|NCT00567190|182916829|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.76||Tested at two-sided 5% significance level|Log Rank (unstratified)|Unstratified|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.76|0.52|<0.0001
91521018|NCT00567190|182916830|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.82|0.58|<0.0001
91521019|NCT00567190|182916830|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.68||||0.0002|TWO_SIDED|95.0|0.56|0.84||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.84|0.56|0.0002
91521020|NCT00567190|182916830|SUPERIORITY||Cox Proportional Hazard|0.66||||0.0008|TWO_SIDED|95.0|0.52|0.84||The threshold for statistical significance was HR≤0.739, p≤0.0138.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.|Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.||0.84|0.52|0.0008
91521021|NCT00567190|182916830|SUPERIORITY||Cox Proportional Hazard|0.64||||0.005|TWO_SIDED|95.0|0.47|0.88||The threshold for statistical significance was HR≤0.603, p≤0.0012.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing pertuzumab with placebo arms.|First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.||0.88|0.47|0.0050
91521022|NCT00567190|182916831|SUPERIORITY||Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|PFS by Investigator - Stratified||0.81|0.59|<0.0001
91776733|NCT00771914|183433884|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.0||||0.31|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Aspirin compared to Placebo.||||0.31
91776734|NCT00771914|183433884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.49|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Lovaza compared to Placebo.||||0.49
91776735|NCT00771914|183433884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0||||0.03|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from both Aspirin and Lovaza compared to Placebo.||||0.03
91776736|NCT00573508|183433885|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.4|||<|0.0001||95.0|6.6|12.2|||ANCOVA|||Statistical Analysis applies to 'Change at End of Treatment'.||12.2|6.6|<0.0001
91776737|NCT00573508|183433886|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.||||<.0001
91776738|NCT00573508|183433887|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-Value represents change from Baseline to Week 12.|ANCOVA|||Statistical Analysis applies to 'Change at Week 12'.||||<.0001
91776739|NCT00573508|183433888|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
91776740|NCT00573508|183433896|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.8|||<|0.0001||95.0|-22.1|-11.6|||ANCOVA|||Statistical Analysis applies to 'Change at EOT'.||-11.6|-22.1|<.0001
91776741|NCT01283555|183434099|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||The p-value presented here represents a comparison of the total number of non-iatrogenic findings at baseline and after one week of product use.|Fisher Exact|||Fishers exact test was used to compare the frequency of non-iatrogenic colposcopic findings at baseline and follow-up visits (after one week of twice-daily product use).||||0.4870
91521023|NCT00567190|182916832|SUPERIORITY||Difference in Objective Response Rates|10.83||||0.0011|TWO_SIDED|95.0|4.2|17.5|||Mantel Haenszel|Stratified by prior treatment status and region.|Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.|Difference in Objective Response (CR + PR) Between Arms||17.5|4.2|0.0011
91521024|NCT00567190|182916832|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.26|2.54||||||Odds Ratio for Objective Response (CR + PR)||2.54|1.26|
91776742|NCT01614249|183434114|SUPERIORITY_OR_OTHER||Slope|1.01|STANDARD_ERROR_OF_MEAN|0.8||0.21|TWO_SIDED|95.0|-0.58|2.6||The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.|ANCOVA|In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.||Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV-seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.||2.60|-0.58|0.21
91776743|NCT03094416|183434129|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.783797|STANDARD_ERROR_OF_MEAN|0.158271|<|0.0001|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||<0.0001
91776744|NCT03094416|183434130|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.037312|STANDARD_ERROR_OF_MEAN|0.026128||0.1607|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.1607
91776745|NCT03094416|183434131|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|3.397559|STANDARD_ERROR_OF_MEAN|4.174962||0.4204|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4204
91521025|NCT00567190|182916833|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.51|0.85||||||||0.85|0.51|
91521026|NCT00567190|182916834|SUPERIORITY||Cox Proportional Hazard|0.97||||0.7161|TWO_SIDED|95.0|0.81|1.16||Stratified by prior treatment status and region.|Log Rank (stratified)||Hazard ratio is comparing Pertuzumab arm with Placebo arm.|||1.16|0.81|0.7161
91521027|NCT00567190|182916843|OTHER|||||||0.7174|||||||Wilcoxon Rank Sum Test|||Wilcoxon Test of Maximum Decrease in LVEF From BL||||0.7174
91776746|NCT03094416|183434132|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.055199|STANDARD_ERROR_OF_MEAN|0.019171||0.0062|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0062
91776747|NCT03094416|183434133|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|0.100127|STANDARD_ERROR_OF_MEAN|0.048171||0.0438|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0438
91776748|NCT03094416|183434134|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.216479|STANDARD_ERROR_OF_MEAN|0.093366||0.0254|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0254
91776749|NCT03094416|183434135|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.011187|STANDARD_ERROR_OF_MEAN|0.036679||0.7619|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.7619
91776750|NCT03094416|183434136|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.121537|STANDARD_ERROR_OF_MEAN|0.064264||0.0655|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0655
91776751|NCT03094416|183434137|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.031636|STANDARD_ERROR_OF_MEAN|0.053033||0.5542|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5542
91776752|NCT03094416|183434138|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.019322|STANDARD_ERROR_OF_MEAN|0.046827||0.682|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.6820
91776753|NCT03094416|183434139|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.049243|STANDARD_ERROR_OF_MEAN|0.024025||0.0468|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0468
91776754|NCT03094416|183434140|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.213171|STANDARD_ERROR_OF_MEAN|0.088103||0.0203|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0203
91776755|NCT03094416|183434141|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.030904|STANDARD_ERROR_OF_MEAN|0.038699||0.4291|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4291
91776756|NCT03094416|183434142|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.025502|STANDARD_ERROR_OF_MEAN|0.047802||0.5967|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5967
91776757|NCT00321789|183434147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.44|TWO_SIDED|95.0|-3.6|8.3|||Mixed Models Analysis|Model was adjusted for a priori race and cardiovascular disease risk level strata.||||8.3|-3.6|0.44
91776758|NCT00321789|183434148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.03|TWO_SIDED|95.0|-0.23|-0.01|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.01|-0.23|0.03
91776759|NCT00321789|183434149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.02|-0.29|0.02
91776760|NCT00321789|183434150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.03|-0.29|0.02
91776761|NCT00321789|183434151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.11|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.03|-0.30|0.11
91776762|NCT00321789|183434152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.26|TWO_SIDED|95.0|-0.06|0.2|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.20|-0.06|0.26
91708280|NCT03252145|183309586|OTHER|||||||0.078|||||||t-test, 2 sided|||Fatigue Domain||||0.078
91776763|NCT00321789|183434153|SUPERIORITY_OR_OTHER||incident rate ratio|1.2||||0.06|TWO_SIDED|95.0|1.0|1.5|||generalized estimating equations|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||1.5|1.0|0.06
91776764|NCT00321789|183434154|SUPERIORITY_OR_OTHER||incident rate ratio|1.1||||0.37|TWO_SIDED|95.0|0.9|1.4|||generalized estimating equations|Model adjusted for a priori race and cardiovascular disease risk category.||||1.4|0.9|0.37
91776765|NCT00321789|183434155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.11||||0.04|TWO_SIDED|95.0|-4.13|-0.09|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||-0.09|-4.13|0.04
91776766|NCT00321789|183434156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.09|TWO_SIDED|95.0|-1.38|0.1|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||0.10|-1.38|0.09
91776767|NCT00321789|183434157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|Model adjusted for a priori race and cardiovascular disease risk category.||||1.7|0.6|0.87
91776768|NCT02485691|183434173|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73||P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.73|0.40|<0.0001
91776769|NCT02485691|183434174|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.64||||0.0078|TWO_SIDED|95.0|0.46|0.89||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.89|0.46|0.0078
91776770|NCT02485691|183434175|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.68|0.40|<0.0001
91776771|NCT02485691|183434176|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0003||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0003
91776772|NCT02485691|183434177|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0004||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0004
91776773|NCT03341299|183434198|SUPERIORITY||Ratio of geometric least square means|0.991||||0.7734|TWO_SIDED|95.0|0.932|1.05|||Mixed Models Analysis|||||1.05|0.932|0.7734
91646370|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8266|TWO_SIDED|95.0|0.43|2.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.87|0.43|0.8266
91776774|NCT03341299|183434199|SUPERIORITY||difference in LS means|-14.5||||0.719|TWO_SIDED|95.0|-94.38|65.38|||Mixed Models Analysis|||||65.38|-94.38|0.7190
91776775|NCT04905134|183434207|OTHER|||||||0.04|||||||Fisher Exact|||Flexible scope compared with the SOC scope||||0.04
91776776|NCT02392806|183434252|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91776777|NCT03518086|183434254|SUPERIORITY||Risk Difference (RD)|11.1||||6e-05|TWO_SIDED|99.875|3.2|19.1|||Cochran-Mantel-Haenszel|||||19.1|3.2|0.00006
91646371|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0712|TWO_SIDED|95.0|0.95|3.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.13|0.95|0.0712
91708281|NCT03252145|183309586|OTHER|||||||0.147|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.147
91776778|NCT03518086|183434255|SUPERIORITY||Risk Difference (RD)|21.4|||<|1e-05|TWO_SIDED|99.875|10.8|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.8|<0.00001
91776779|NCT03518086|183434256|SUPERIORITY||Risk Difference (RD)|15.4|||<|1e-05|TWO_SIDED|99.875|6.3|24.5|||Cochran-Mantel-Haenszel|||||24.5|6.3|<0.00001
91776780|NCT03518086|183434257|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|99.875|11.4|23.6|||Cochran-Mantel-Haenszel|||||23.6|11.4|<0.001
91776781|NCT03518086|183434258|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|13.8|26.6|||Cochran-Mantel-Haenszel|||||26.6|13.8|<0.001
91776782|NCT03518086|183434259|SUPERIORITY||Risk Difference (RD)|13.7|||<|0.001|TWO_SIDED|95.0|8.6|18.7|||Cochran-Mantel-Haenszel|||||18.7|8.6|<0.001
91776783|NCT03518086|183434260|SUPERIORITY||Risk Difference (RD)|19.5|||<|1e-05|TWO_SIDED|95.0|13.2|25.8|||Cochran-Mantel-Haenszel|||||25.8|13.2|<0.00001
91776784|NCT03518086|183434261|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.159|<|1e-05|TWO_SIDED|99.875|-1.47|-0.44|||Mixed Models Analysis||The confidence interval of 99.875 % was chosen to match the significance level.|||-0.44|-1.47|<0.00001
91521028|NCT00374322|182916848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.286|TWO_SIDED|95.0|0.77|1.08||The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.|Log Rank||Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.|||1.08|0.77|0.286
91776785|NCT03518086|183434262|SUPERIORITY||Mean Difference (Net)|13.21|STANDARD_ERROR_OF_MEAN|2.005|<|0.001|TWO_SIDED|95.0|9.28|17.15|||ANCOVA|||||17.15|9.28|<0.001
91776786|NCT03518086|183434263|SUPERIORITY||Mean Difference (Net)|-935.6|STANDARD_ERROR_OF_MEAN|218.09|<|0.001|TWO_SIDED|95.0|-1363.64|-507.55|||Mixed Models Analysis|||||-507.55|-1363.64|<0.001
91776787|NCT03563209|183434301|OTHER||||||<|0.001||||||p-value was adjusted for multiple comparisons. A priori threshold for statistical significance was set to 0.05/3 (0.0167)|Friedman|||Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)||||<0.001
91776788|NCT00303069|183434304|SUPERIORITY_OR_OTHER||Risk Difference (RD)|84.5|||<|0.001|TWO_SIDED|95.0|65.2|93.6||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||93.6|65.2|<0.001
91776789|NCT00303069|183434304|SUPERIORITY_OR_OTHER||Risk Difference (RD)|81.6|||<|0.01|TWO_SIDED|95.0|61.6|92.0||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||92.0|61.6|<0.01
91776790|NCT00303069|183434304|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|6.7|43.8||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||43.8|6.7|<0.001
91776791|NCT00303069|183434305|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.9|||<|0.001|TWO_SIDED|95.0|17.2|48.3||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||48.3|17.2|<0.001
91790180|NCT02660138|183459523|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|4.0||||0.0007|TWO_SIDED|95.0|1.8|8.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||8.86|1.80|0.0007
91521029|NCT01984697|182916880|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.15|||<|0.001|TWO_SIDED|95.0|1.83|2.53|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.53|1.83|<0.001
91521030|NCT01984697|182916880|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.73|2.36|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.36|1.73|<0.001
91708282|NCT03252145|183309586|OTHER|||||||0.004|||||||t-test, 2 sided|||Roles/Activity Domain||||0.004
91776792|NCT00303069|183434305|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.4|||<|0.001|TWO_SIDED|95.0|1.6|32.1||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||32.1|1.6|<0.001
91581872|NCT02084056|183053516|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|95.49|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|89.73|101.62|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.62|89.73|<0.0001
91581873|NCT02084056|183053516|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.19|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|90.73|106.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||106.27|90.73|0.0002
91646372|NCT01236053|183184705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.2674|TWO_SIDED|95.0|0.77|2.6|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.60|0.77|0.2674
91776793|NCT00303069|183434305|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||<|0.001|TWO_SIDED|95.0|-8.2|16.9||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||16.9|-8.2|<0.001
91776794|NCT01084655|183434317|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square(LS)Means|1.204|||||TWO_SIDED|90.0|0.87|1.666||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.666|0.870|
91776795|NCT01084655|183434318|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.074|||||TWO_SIDED|90.0|0.793|1.455||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.455|0.793|
91776796|NCT01084655|183434321|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.066|||||TWO_SIDED|90.0|0.802|1.417||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.417|0.802|
91776797|NCT01084655|183434322|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.068|||||TWO_SIDED|90.0|0.955|1.195||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.195|0.955|
91776798|NCT03027609|183434346|SUPERIORITY|comparison between the treatment and placebo|Risk Difference (RD)|-5.54||||0.6154|TWO_SIDED|95.0|-21.9|10.8||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||10.8|-21.9|0.6154
91776799|NCT03027609|183434347|SUPERIORITY||Risk Difference (RD)|4.01||||0.8426|TWO_SIDED|95.0|-18.5|10.5||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||10.5|-18.5|0.8426
91776800|NCT03027609|183434348|SUPERIORITY|comparison between the treatment and placebo|P value CMH|3.6||||0.3562|TWO_SIDED|95.0|-13.1|20.3||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||20.3|-13.1|0.3562
91776801|NCT03027609|183434349|SUPERIORITY|Comparison between the treatment and placebo|P value CMH|-2.81||||0.8472|TWO_SIDED|95.0|-18.9|13.2||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||13.2|-18.9|0.8472
91776802|NCT03027609|183434350|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4616|TWO_SIDED|95.0|-16.2|60.6||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||60.6|-16.2|0.4616
91776803|NCT03027609|183434350|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4053|TWO_SIDED|95.0|-13.3|57.8||Data for Day 21|Chi-squared|||Data for Day 21||57.8|-13.3|0.4053
91776804|NCT03027609|183434351|SUPERIORITY||Mean Difference (Final Values)|38.1||||0.0833|TWO_SIDED|90.0|-14.8|90.9||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||90.9|-14.8|0.0833
91581874|NCT00324116|183053543|SUPERIORITY_OR_OTHER||percent responders|85.0||||||95.0|76.0|95.0|||||Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.|||95|76|
91581875|NCT00324116|183053544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29||||||95.0|-6.83|-1.75|||||95% CI for the change in mean value obtained from one sample t-test.|6 weeks||-1.75|-6.83|
91646373|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61||||0.0005|TWO_SIDED|95.0|1.75|7.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.46|1.75|0.0005
91708283|NCT03252145|183309586|OTHER|||||||0.032|||||||t-test, 2 sided|||Pain Interference Domain||||0.032
91776805|NCT03027609|183434351|SUPERIORITY||Mean Difference (Net)|23.8||||0.5151|TWO_SIDED|90.0|-30.5|78.1||Data for Day 21|Chi-squared|Marginally statistically significant only if p\<0.1 Day 21||Data for Day 21||78.1|-30.5|0.5151
91776806|NCT03182374|183434352|SUPERIORITY||||||<|0.0001||||||ITT Population|t-test, 2 sided|||||||<0.0001
91776807|NCT03182374|183434353|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
91776808|NCT03182374|183434354|SUPERIORITY|||||||0.6655||||||PP Population|t-test, 2 sided|||||||0.6655
91708284|NCT03252145|183309587|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
91776809|NCT03182374|183434355|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
91646374|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25||||0.0019|TWO_SIDED|95.0|1.55|6.83|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.83|1.55|0.0019
91708285|NCT03252145|183309588|OTHER|||||||0.603|||||||t-test, 2 sided|||||||0.603
91776810|NCT03182374|183434356|SUPERIORITY||||||<|0.05||||||PP population|t-test, 2 sided|||||||<0.05
91776811|NCT03182374|183434357|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91776812|NCT01462370|183434358|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin is -3.7 units.|Difference in LS Means|0.89||||0.043|TWO_SIDED|95.0|0.03|1.76||A priori threshold for statistical significance = \<0.025 (one-sided).|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.||1.76|0.03|0.043
91776813|NCT01462370|183434359|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.2||||0.768|TWO_SIDED|95.0|-1.16|1.57||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||1.57|-1.16|0.768
91776814|NCT01462370|183434360|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.007|TWO_SIDED|95.0|0.07|0.45||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.07|0.007
91776815|NCT01462370|183434361|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.36|||<|0.001|TWO_SIDED|95.0|0.17|0.54||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.54|0.17|<0.001
91776816|NCT01462370|183434362|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.371|TWO_SIDED|95.0|0.7|1.14||A priori threshold for statistical significance = \<0.05.|Regression, Cox|Adjusted for treatment, period, and baseline pain intensity.||||1.14|0.70|0.371
91776817|NCT01462370|183434363|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.051|TWO_SIDED|95.0|0.0|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|-0.00|0.051
91776818|NCT01462370|183434364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference in LS Means|0.17||||0.019|TWO_SIDED|95.0|0.03|0.32||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.32|0.03|0.019
91776819|NCT01462370|183434366|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.31||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.31|0.10|<0.001
91776820|NCT01462370|183434367|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.28||||0.002|TWO_SIDED|95.0|0.1|0.45||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.10|0.002
91776821|NCT01462370|183434368|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.11||||0.011|TWO_SIDED|95.0|0.03|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|0.03|0.011
91776822|NCT01462370|183434369|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.004|TWO_SIDED|95.0|0.08|0.44||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.44|0.08|0.004
91776823|NCT01462370|183434370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.112|TWO_SIDED|95.0|0.9|2.87||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||2.87|0.90|0.112
91776824|NCT01462370|183434371|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.019|TWO_SIDED|95.0|1.12|3.45||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||3.45|1.12|0.019
91776825|NCT03651479|183434372|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91776826|NCT01391546|183434390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was achieved if the lower bound of the 2-sided 95% confidence interval (CI) for the GMT ratio was greater than 2/3|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18|||longitudinal regression model|Model adjusted for pre-vaccination titres and age at vaccination in years|GMT ratio = GMT IM route divided by GMT SC route|||1.18|0.93|<0.001
91776827|NCT01391546|183434391|SUPERIORITY_OR_OTHER||GMFR|2.7|||||TWO_SIDED|95.0|2.4|3.0|||||GMFR = GMT Post-vaccination/GMT Pre-vaccination|Acceptability was demonstrated if the lower bound of the two-sided 95% CI was \>1.4||3.0|2.4|
91776828|NCT02392637|183434442|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
91776829|NCT02392637|183434443|SUPERIORITY|||||||0.39|||||||Log Rank|||||||0.39
91776830|NCT01761877|183434445|OTHER|Mixed Models Analysis|||||<|0.05||||||A p value was calculated for change in breast density from baseline to 12 months separately for each study arm.|Mixed Models Analysis|||The study was designed to assess change in breast density using fat/water MRI after 12 months of sulindac intervention in postmenopausal breast cancer patients taking aromatase inhibitors for the treatment of estrogen receptor positive breast cancer. A non-randomized observation arm was included with the same eligibility criteria to assess change in breast density over 12 months using the fat/water MRI method of quantifying breast density. Change was examined separately for each arm.||||<0.05
91646375|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.0024|TWO_SIDED|95.0|1.39|4.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.55|1.39|0.0024
91708286|NCT03252145|183309589|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
91708287|NCT03252145|183309590|OTHER|||||||0.511|||||||t-test, 2 sided|||||||0.511
91708288|NCT03252145|183309591|OTHER|||||||0.326|||||||t-test, 2 sided|||||||0.326
91776831|NCT01761877|183434446|OTHER||||||<|0.05||||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
91776832|NCT01761877|183434447|OTHER||||||<|0.05|TWO_SIDED|95.0||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
91776833|NCT03697252|183434472|SUPERIORITY||LS mean difference|-11.56|||<|0.0001|TWO_SIDED|95.0|-16.07|-7.05|||Mixed model for repeated measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-7.05|-16.07|<0.0001
91776834|NCT03697252|183434474|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of KarXT and Placebo at Week 5||||<0.001
91776835|NCT00106704|183434478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-90.0|-0.57|||ANCOVA|Model terms: treatment, stratum (on metformin or not), baseline A1C||||-0.57|-90.0|<0.001
91776836|NCT00106704|183434479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.1|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-28.4|-11.8|||ANCOVA|Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C||||-11.8|-28.4|<0.001
91776837|NCT01780506|183434480|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.|Difference in percentages|0.5||||0.78|TWO_SIDED|95.002|-3.0|4.0||P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|Cochran-Mantel-Haenszel||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|||4.0|-3.0|0.78
91776838|NCT01867671|183434511|SUPERIORITY||Odds Ratio (OR)|205.45|||<|0.0001|TWO_SIDED|95.0|24.0|1758.51|||Regression, Logistic|||||1758.51|24.00|<0.0001
91776839|NCT01867671|183434512|SUPERIORITY||Odds Ratio (OR)|27.82|||<|0.0031|TWO_SIDED|95.0|3.07|252.33|||Regression, Logistic|||||252.33|3.07|<0.0031
91776840|NCT01867671|183434513|OTHER|McNemar's Test|Simple Kappa Coefficient|0.162|||<|0.0001|TWO_SIDED|95.0|0.0628|0.2612|||McNemar|||||0.2612|0.0628|<0.0001
91776841|NCT01867671|183434514|SUPERIORITY||Mean Difference (Final Values)|1464.0|||<|0.0001|TWO_SIDED|95.0|944.0|1985.0|||Chi-squared|||||1985|944|<0.0001
91776842|NCT04852302|183434516|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-1.81|STANDARD_DEVIATION|4.81||0.168|TWO_SIDED|95.0|-4.47|0.86||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||Null hypothesis was that the mean difference between the paired observations is zero.||0.86|-4.47|0.168
91776843|NCT04852302|183434517|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-0.3|STANDARD_DEVIATION|3.59||0.752|TWO_SIDED|95.0|-2.29|1.69||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||1.69|-2.29|0.752
91776844|NCT04852302|183434518|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-4.67|STANDARD_DEVIATION|16.26||0.285|TWO_SIDED|95.0|-13.67|4.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||4.34|-13.67|0.285
91776845|NCT04852302|183434518|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-2.2|STANDARD_DEVIATION|17.22||0.628|TWO_SIDED|95.0|-11.74|7.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||7.34|-11.74|0.628
91776846|NCT01743469|183434535|SUPERIORITY_OR_OTHER|||||||0.142||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.142
91776847|NCT01743469|183434535|SUPERIORITY_OR_OTHER|||||||1||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>35%).||||1.000
91776848|NCT01743469|183434535|SUPERIORITY_OR_OTHER|||||||0.8||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.800
91776849|NCT01743469|183434535|SUPERIORITY_OR_OTHER|||||||0.63||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>15%).||||0.630
91776850|NCT01743469|183434536|SUPERIORITY_OR_OTHER|||||||0.5||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with a prespecified threshold (\>20%).||||0.500
91776851|NCT03253796|183434550|SUPERIORITY||Difference in percentage|50.2|||<|0.001|TWO_SIDED|95.0|34.1|63.6|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||63.6|34.1|<0.001
91776852|NCT03253796|183434550|SUPERIORITY||Difference in percentage|34.4|||<|0.001|TWO_SIDED|95.0|17.0|49.7|||Meittinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||49.7|17.0|<0.001
91776853|NCT03253796|183434553|SUPERIORITY||Difference in percentage|9.5|||||TWO_SIDED|95.0|3.3|19.4|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||19.4|3.3|
91776854|NCT03253796|183434553|SUPERIORITY||Difference in percentage|3.2|||||TWO_SIDED|95.0|-2.8|10.9|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||10.9|-2.8|
91776855|NCT03253796|183434555|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
91646376|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.0115|TWO_SIDED|95.0|1.19|4.0|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.00|1.19|0.0115
91776856|NCT03253796|183434555|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
91708289|NCT01763827|183309600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-61.14|-53.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.14|-61.14|<0.001
91708290|NCT01763827|183309600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.78|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|-58.46|-51.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.10|-58.46|<0.001
91776857|NCT03253796|183434557|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.0|0.2|
91646377|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.6281|TWO_SIDED|95.0|0.17|2.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.96|0.17|0.6281
91708291|NCT01763827|183309600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.29|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-43.28|-35.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.31|-43.28|<0.001
91708292|NCT01763827|183309600|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|1.88|<|0.001|TWO_SIDED|95.0|-41.24|-33.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.86|-41.24|<0.001
91708293|NCT01763827|183309601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-59.95|-53.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.04|-59.95|<0.001
91708294|NCT01763827|183309601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.4|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-60.66|-54.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.14|-60.66|<0.001
91708295|NCT01763827|183309601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.41|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-42.87|-35.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.94|-42.87|<0.001
91708296|NCT01763827|183309601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.69|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-42.97|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.42|-42.97|<0.001
91708297|NCT01763827|183309602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.6|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-85.0|-74.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.2|-85.0|<0.001
91708298|NCT01763827|183309602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-81.9|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-87.0|-76.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-76.9|-87.0|<0.001
91581876|NCT00324116|183053544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.86||||||95.0|-9.06|-2.67|||||95% CI for the change in mean value obtained from one sample t-test.|12 weeks||-2.67|-9.06|
91581877|NCT00324116|183053544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.12||||||95.0|-16.28|-5.96|||||95% CI for the change in mean value obtained from one sample t-test.|54 weeks||-5.96|-16.28|
91581878|NCT00324116|183053545|SUPERIORITY_OR_OTHER||percentage of subjects|5.0||||||95.0|1.61|11.32|||||Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations|||11.32|1.61|
91581879|NCT00324116|183053546|SUPERIORITY_OR_OTHER||percentage of subjects|22.5||||||95.0|14.22|32.11|||||Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||32.11|14.22|
91776858|NCT03253796|183434557|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.1|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.1|0.2|
91776859|NCT03253796|183434559|SUPERIORITY||Difference in percentage|24.9|||||TWO_SIDED|95.0|8.5|40.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||40.3|8.5|
91776860|NCT03253796|183434559|SUPERIORITY||Difference in percentage|5.9|||||TWO_SIDED|95.0|-9.9|21.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||21.3|-9.9|
91776861|NCT03253796|183434561|SUPERIORITY||Difference in percentage|24.4|||||TWO_SIDED|95.0|9.1|39.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||39.0|9.1|
91776862|NCT03253796|183434561|SUPERIORITY||Difference in percentage|22.8|||||TWO_SIDED|95.0|7.3|37.7|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||37.7|7.3|
91776863|NCT03253796|183434565|SUPERIORITY||Difference in percentage|32.9|||<|0.001|TWO_SIDED|95.0|19.2|44.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||44.5|19.2|<0.001
91581880|NCT00324116|183053547|SUPERIORITY_OR_OTHER||percentage of subjects|13.75||||||95.0|7.39|22.24|||||Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||22.24|7.39|
91581881|NCT00324116|183053548|SUPERIORITY_OR_OTHER||percentage of subjects|25.97||||||95.0|16.28|34.81|||||Proportion of subjects progressing to \<=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||34.81|16.28|
91776864|NCT03253796|183434566|SUPERIORITY||Difference in percentage|15.9||||0.037|TWO_SIDED|95.0|0.9|30.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||30.5|0.9|0.037
91776865|NCT00528112|183434568|SUPERIORITY_OR_OTHER||failure rate|0.009|||||TWO_SIDED|95.0|0.005|0.017||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.017|0.005|
91776866|NCT00528112|183434568|SUPERIORITY_OR_OTHER||failure rate|0.01||||||95.0|0.005|0.018||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.018|0.005|
91581882|NCT01451827|183053564|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0127|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0127
91581883|NCT01451827|183053564|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0108|TWO_SIDED|95.0|0.95|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.95|0.0108
91776867|NCT00528112|183434590|SUPERIORITY_OR_OTHER||failure rate|0.01445|||||TWO_SIDED|95.0|0.00823|0.02531||||||Cumulative failure rate (Kaplan-Meier) at 5 years||0.02531|0.00823|
91776868|NCT02718898|183434606|SUPERIORITY||Odds Ratio (OR)|33.8|||<|0.001|TWO_SIDED|95.0|12.39|92.23|||Regression, Logistic|||||92.23|12.39|<0.001
91776869|NCT02718898|183434607|SUPERIORITY||Odds Ratio (OR)|102.55|||<|0.001|TWO_SIDED|95.0|22.79|461.43|||Regression, Logistic|||||461.43|22.79|<0.001
91776870|NCT02718898|183434608|SUPERIORITY||Odds Ratio (OR)|16.27|||<|0.001|TWO_SIDED|95.0|5.71|46.4|||Regression, Logistic|||||46.40|5.71|<0.001
91776871|NCT02718898|183434609|SUPERIORITY||Odds Ratio (OR)|13.57|||<|0.001|TWO_SIDED|95.0|4.57|40.29|||Regression, Logistic|||||40.29|4.57|<0.001
91776872|NCT02718898|183434610|SUPERIORITY||Odds Ratio (OR)|9.84|||<|0.001|TWO_SIDED|95.0|3.08|31.4|||Regression, Logistic|||||31.40|3.08|<0.001
91776873|NCT02718898|183434611|SUPERIORITY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|-10.1|-6.7|||Mixed Models Analysis|||||-6.7|-10.1|<0.001
91776874|NCT02718898|183434612|SUPERIORITY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-24.3|-15.8|||Mixed Models Analysis|||||-15.8|-24.3|<0.001
91776875|NCT02718898|183434613|SUPERIORITY||Odds Ratio (OR)|13.95|||<|0.001|TWO_SIDED|95.0|6.12|31.8|||Regression, Logistic|||||31.80|6.12|<0.001
91776876|NCT02718898|183434614|SUPERIORITY||Mean Difference (Final Values)|4.506|STANDARD_ERROR_OF_MEAN|1.1339|<|0.001|TWO_SIDED|95.0|2.264|6.748|||ANCOVA|||||6.748|2.264|<0.001
91776877|NCT02718898|183434615|SUPERIORITY||Mean Difference (Final Values)|1.797|STANDARD_ERROR_OF_MEAN|1.0367||0.085|TWO_SIDED|95.0|-0.253|3.847|||ANCOVA|||||3.847|-0.253|0.085
91776878|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|3.015|<|0.001|TWO_SIDED|95.0|-34.72|-22.78|||Mixed Models Analysis|||Total Score||-22.78|-34.72|<0.001
91776879|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.399|<|0.001|TWO_SIDED|95.0|-4.6|-3.02|||Mixed Models Analysis|||Itch||-3.02|-4.60|<0.001
91776880|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.405|<|0.001|TWO_SIDED|95.0|-4.3|-2.7|||Mixed Models Analysis|||Pain||-2.70|-4.30|<0.001
91776881|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.85|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.66|-3.04|||Mixed Models Analysis|||Discomfort||-3.04|-4.66|<0.001
91776882|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.04|-2.42|||Mixed Models Analysis|||Stinging||-2.42|-4.04|<0.001
91776883|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-3.99|-2.41|||Mixed Models Analysis|||Burning||-2.41|-3.99|<0.001
91581884|NCT01451827|183053564|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0155|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0155
91581885|NCT01451827|183053564|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.99||||0.2417|TWO_SIDED|95.0|0.97|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.01|0.97|0.2417
91708299|NCT01763827|183309602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-60.7|-49.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-49.9|-60.7|<0.001
91776884|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|-4.59|-3.03|||Mixed Models Analysis|||Redness||-3.03|-4.59|<0.001
91776885|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|0.377|<|0.001|TWO_SIDED|95.0|-4.53|-3.03|||Mixed Models Analysis|||Scaling||-3.03|-4.53|<0.001
91776886|NCT02718898|183434616|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|0.385|<|0.001|TWO_SIDED|95.0|-4.31|-2.79|||Mixed Models Analysis|||Cracking||-2.79|-4.31|<0.001
91776887|NCT02163538|183434618|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91776888|NCT02163538|183434619|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
91581886|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0002|TWO_SIDED|95.0|0.31|0.99|||ANCOVA|||Urinary Frequency||0.99|0.31|0.0002
91776889|NCT02163538|183434620|SUPERIORITY|||||||0.582|||||||Chi-squared|||||||0.582
91776890|NCT02163538|183434621|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
91776891|NCT02163538|183434622|SUPERIORITY|||||||0.0281|||||||Wilcoxon (Mann-Whitney)|||||||0.0281
91776892|NCT02163538|183434623|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|||||||.0821
91776893|NCT01345240|183434624|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.|Difference in percent seroprotection|-3.95|||||TWO_SIDED|95.0|-7.12|-2.16||||||Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.||-2.16|-7.12|
91776894|NCT01345240|183434627|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.20|0.69|
91776895|NCT01345240|183434627|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.32|0.76|
91581887|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.4|1.08|||ANCOVA|||Urinary Frequency||1.08|0.40|< 0.0001
91581888|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||<|0.0001|TWO_SIDED|95.0|0.58|1.25|||ANCOVA|||Urinary Frequency||1.25|0.58|< 0.0001
91581889|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0004|TWO_SIDED|95.0|0.3|1.01|||ANCOVA|||Urinary Urgency||1.01|0.30|0.0004
91776896|NCT01345240|183434627|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.45|0.84|
91776897|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.39|0.95|
91776898|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.2|||||TWO_SIDED|95.0|0.97|1.48|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.48|0.97|
91776899|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.27|||||TWO_SIDED|95.0|1.06|1.52|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.52|1.06|
91776900|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.17|||||TWO_SIDED|95.0|0.83|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.83|
91776901|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.33|0.94|
91776902|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.32|||||TWO_SIDED|95.0|1.08|1.63|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.63|1.08|
91776903|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.77|1.27|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.27|0.77|
91776904|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.81|||||TWO_SIDED|95.0|1.38|2.38|||ANOVA|||To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||2.38|1.38|
91776905|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.21|||||TWO_SIDED|95.0|0.89|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.89|
91776906|NCT01345240|183434635|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.81|1.55|||ANOVA|||To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.55|0.81|
91708300|NCT01763827|183309602|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-61.1|-51.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-51.0|-61.1|<0.001
91581890|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0004|TWO_SIDED|95.0|0.29|1.01|||ANCOVA|||Urinary Urgency||1.01|0.29|0.0004
91708301|NCT01763827|183309603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.4|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-86.4|-74.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.3|-86.4|<0.001
91581891|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.0001|TWO_SIDED|95.0|0.63|1.34|||ANCOVA|||Urinary Urgency||1.34|0.63|< 0.0001
91581892|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.0002|TWO_SIDED|95.0|0.42|1.3|||ANCOVA|||Nocturia||1.30|0.42|0.0002
91581893|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.07|||<|0.0001|TWO_SIDED|95.0|0.63|1.51|||ANCOVA|||Nocturia||1.51|0.63|< 0.0001
91581894|NCT01451827|183053565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.0001|TWO_SIDED|95.0|0.8|1.66|||ANCOVA|||Nocturia||1.66|0.80|< 0.0001
91581895|NCT01451827|183053566|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0209|TWO_SIDED|95.0|0.94|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.94|0.0209
91581896|NCT01451827|183053566|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0287|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0287
91581897|NCT01451827|183053566|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0298|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0298
91581898|NCT01451827|183053566|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.2306|TWO_SIDED|95.0|0.94|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.01|0.94|0.2306
91708302|NCT01763827|183309603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-83.4|-72.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-72.2|-83.4|<0.001
91581899|NCT01642251|183053591|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|80.0|0.22|0.51||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients within the male/abnormal LDH stratum||0.51|0.22|<0.001
91581900|NCT01642251|183053591|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.18|TWO_SIDED|80.0|0.6|1.09||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients not in the male/abnormal LDH stratum.||1.09|0.60|0.18
91776907|NCT01345240|183434641|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.20|0.97|
91776908|NCT01345240|183434641|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.21|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.21|0.97|
91581901|NCT01642251|183053591|SUPERIORITY|||||||0.028||||||p value for the interaction by treatment and stratification factor|Regression, Cox|||If there was a significant treatment-by-stratification factor interaction, the results would be reported separately for each stratum. Significance was defined as the p value was less than 0.05.||||0.028
91581902|NCT01642251|183053592|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.17|TWO_SIDED|80.0|0.64|1.07|||Regression, Cox|stratified on the stratification factors used for randomization||||1.07|0.64|0.17
91581903|NCT01642251|183053594|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91581904|NCT03988920|183053600|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7439|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.7439
91581905|NCT01942590|183053620|OTHER|||||||0.0512|||||||t-test, 1 sided|||||||0.0512
91581906|NCT01942590|183053620|OTHER|||||||0.434|||||||t-test, 1 sided|||||||0.434
91581907|NCT01942590|183053621|OTHER|||||||0.0816||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.0816
91581908|NCT01942590|183053621|OTHER|||||||0.3318||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.3318
91581909|NCT01942590|183053622|OTHER|||||||0.2074|||||||t-test, 1 sided|||||||0.2074
91581910|NCT01942590|183053622|OTHER|||||||0.332|||||||t-test, 1 sided|||||||0.332
91581911|NCT01942590|183053623|OTHER|||||||0.233||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.233
91581912|NCT01942590|183053623|OTHER|||||||0.142||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.142
91581913|NCT01942590|183053624|OTHER|||||||0.019|||||||t-test, 1 sided|||||||0.019
91581914|NCT01942590|183053624|OTHER|||||||0.366|||||||t-test, 1 sided|||||||0.366
91581915|NCT01942590|183053625|OTHER|||||||0.161|||||||t-test, 1 sided|||||||0.161
91581916|NCT01942590|183053625|OTHER|||||||0.43|||||||t-test, 1 sided|||||||0.43
91581917|NCT01942590|183053626|OTHER|||||||0.01|||||||t-test, 1 sided|||Baseline, week 18||||0.01
91581918|NCT01942590|183053626|OTHER|||||||0.004|||||||t-test, 1 sided|||Baseline, week 52||||0.004
91581919|NCT01942590|183053626|OTHER|||||||0.154|||||||t-test, 1 sided|||Baseline, week 18||||0.154
91776909|NCT01345240|183434641|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.22|0.98|
91776910|NCT01345240|183434642|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.76|1.61|||ANOVA|||To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen||1.61|0.76|
91581920|NCT01942590|183053626|OTHER|||||||0.211|||||||t-test, 1 sided|||Baseline, Week 52||||0.211
91581921|NCT01942590|183053627|OTHER|||||||0.006|||||||t-test, 1 sided|||Baseline, Week 18||||0.006
91581922|NCT01942590|183053627|OTHER|||||||0.007|||||||t-test, 1 sided|||Baseline, Week 52||||0.007
91646378|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.5103|TWO_SIDED|95.0|0.14|2.62|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.62|0.14|0.5103
91708303|NCT01763827|183309603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-61.1|-49.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-49.0|-61.1|<0.001
91776911|NCT00617734|183434684|SUPERIORITY_OR_OTHER|||||||0.0667|||||||Log Rank|||||||0.0667
91776912|NCT00617734|183434685|SUPERIORITY_OR_OTHER|||||||0.1935|||||||Fisher Exact|||||||0.1935
91776913|NCT00617734|183434687|SUPERIORITY_OR_OTHER|||||||0.7455|||||||Log Rank|||||||0.7455
91776914|NCT05712460|183434710|OTHER||Ratio|126.65|||||TWO_SIDED|90.0|106.87|150.1|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||150.10|106.87|
91776915|NCT05712460|183434711|OTHER||Ratio|142.94|||||TWO_SIDED|90.0|117.2|174.32|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||174.32|117.20|
91776916|NCT05560425|183434725|EQUIVALENCE|"The equivalence margin is a range of the compliance score for which the independent training of skills in each group is close enough to be considered equivalent."|Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|3.45|<|0.05|TWO_SIDED|95.0|-6.22|8.79|||t-test, 1 sided|degrees of freedom = 12||Null hypothesis: Compliance with independent training of skills is not equivalent between groups.||8.79|-6.22|<0.05
91776917|NCT05737069|183434810|EQUIVALENCE|The two products were considered to be bioequivalent if 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0008|||||TWO_SIDED|90.0|0.9698|1.0327||||||||1.0327|0.9698|
91776918|NCT05737069|183434811|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0023|||||TWO_SIDED|90.0|0.971|1.0346||||||||1.0346|0.9710|
91776919|NCT05737069|183434812|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9825|||||TWO_SIDED|90.0|0.9383|1.0288||||||||1.0288|0.9383|
91581923|NCT01942590|183053627|OTHER|||||||0.297|||||||t-test, 1 sided|||Baseline, Week 18||||0.297
91581924|NCT01942590|183053627|OTHER|||||||0.196|||||||t-test, 1 sided|||Baseline, Week 52||||0.196
91581925|NCT01942590|183053628|OTHER|||||||0.3639|||||||t-test, 1 sided|||Baseline Week 18||||0.3639
91581926|NCT01942590|183053628|OTHER|||||||0.0371|||||||t-test, 1 sided|||Baseline, Week 52||||0.0371
91581927|NCT01942590|183053629|OTHER|||||||0.268|||||||t-test, 1 sided|||Baseline, Week 18||||0.268
91581928|NCT01942590|183053629|OTHER|||||||0.0036|||||||t-test, 1 sided|||Baseline, Week 52||||0.0036
91581929|NCT01942590|183053629|OTHER|||||||0.286|||||||t-test, 1 sided|||Baseline, Week 18||||0.286
91581930|NCT01942590|183053629|OTHER|||||||0.279|||||||t-test, 1 sided|||Baseline, Week 52||||0.279
91581931|NCT01942590|183053630|OTHER|||||||0.479|||||||t-test, 1 sided|||Baseline, Week 18||||0.479
91581932|NCT01942590|183053630|OTHER|||||||0.059|||||||t-test, 1 sided|||Baseline, Week 52||||0.059
91581933|NCT01942590|183053630|OTHER|||||||0.152|||||||t-test, 1 sided|||Baseline, Week 18||||0.152
91581934|NCT01942590|183053630|OTHER|||||||0.118|||||||t-test, 1 sided|||Baseline, Week 52||||0.118
91581935|NCT01226095|183053808|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91646379|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.7733|TWO_SIDED|95.0|0.45|2.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.90|0.45|0.7733
91646380|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.837|TWO_SIDED|95.0|0.43|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.81|0.43|0.8370
91776920|NCT05737069|183434813|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9916|||||TWO_SIDED|90.0|0.9755|1.0081||||||||1.0081|0.9755|
91776921|NCT05737069|183434814|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9776|||||TWO_SIDED|90.0|0.9432|1.0133||||||||1.0133|0.9432|
91776922|NCT05737069|183434815|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9982|||||TWO_SIDED|90.0|0.9431|1.0567||||||||1.0567|0.9431|
91776923|NCT05565742|183434842|SUPERIORITY||LS Mean difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|-55.8|-20.6|||Mixed Models Analysis|||||-20.6|-55.8|<0.001
91581936|NCT00857272|183053818|NON_INFERIORITY_OR_EQUIVALENCE|Fifteen percent has been established as an acceptable non-inferiority margin for evaluation of investigational bowel preparations in previous studies of FDA approved preparations (e.g. NuLytely, MoviPrep).|Difference in success rates|-2.5||||0.005|TWO_SIDED|95.0|-11.9|6.8|||Chi-squared|||"The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2\<=D0 versus Alternative Hypothesis H1: P1-P2=D1\>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%."||6.8|-11.9|0.005
91581937|NCT03283072|183053819|SUPERIORITY|||||||0.592|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.592
91646381|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.198|TWO_SIDED|95.0|0.75|4.1|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.10|0.75|0.1980
91776924|NCT05565742|183434842|SUPERIORITY||LS Mean difference (Final Values)|-75.2|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-80.4|-68.5|||Mixed Models Analysis|||||-68.5|-80.4|<0.001
91776925|NCT05565742|183434842|SUPERIORITY||LS Mean difference (Final Values)|-93.9|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-95.1|-92.5|||Mixed Models Analysis|||||-92.5|-95.1|<0.001
91776926|NCT05565742|183434843|SUPERIORITY||LS Mean difference (Final Values)|-38.9|STANDARD_ERROR_OF_MEAN|9.43||0.002|TWO_SIDED|95.0|-54.9|-17.2|||Mixed Models Analysis|||||-17.2|-54.9|0.002
91776927|NCT05565742|183434843|SUPERIORITY||LS Mean difference (Final Values)|-77.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-82.4|-71.1|||Mixed Models Analysis|||||-71.1|-82.4|<0.001
91776928|NCT05565742|183434843|SUPERIORITY||LS Mean difference (Final Values)|-95.0|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-96.1|-93.6|||Mixed Models Analysis|||||-93.6|-96.1|<0.001
91776929|NCT05565742|183434843|SUPERIORITY||LS Mean difference (Final Values)|-76.8|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-81.9|-70.2|||Mixed Models Analysis|||||-70.2|-81.9|<0.001
91776930|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|112.03||||0.001|TWO_SIDED|95.0|6.35|1975.13|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1975.13|6.35|0.001
91776931|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|2762.52|||<|0.001|TWO_SIDED|95.0|142.74|53463.34|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||53463.34|142.74|<0.001
91776932|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|50904.09|||<|0.001|TWO_SIDED|95.0|1700.95|1523398.1|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1523398.10|1700.95|<0.001
91776933|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|27.94||||0.026|TWO_SIDED|95.0|1.48|527.74|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||527.74|1.48|0.026
91776934|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|309.36|||<|0.001|TWO_SIDED|95.0|17.99|5320.81|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||5320.81|17.99|<0.001
91776935|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|3060.16|||<|0.001|TWO_SIDED|95.0|166.84|56127.55|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||56127.55|166.84|<0.001
91776936|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|32.91||||0.021|TWO_SIDED|95.0|1.7|635.94|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||635.94|1.70|0.021
91776937|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|579.62|||<|0.001|TWO_SIDED|95.0|31.48|10673.41|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||10673.41|31.48|<0.001
91776938|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|14659.81|||<|0.001|TWO_SIDED|95.0|646.35|332498.98|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||332498.98|646.35|<0.001
91776939|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|15.94||||0.071|TWO_SIDED|95.0|0.79|321.21|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||321.21|0.79|0.071
91581938|NCT03283072|183053820|SUPERIORITY|||||||0.721|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.721
91581939|NCT03283072|183053821|SUPERIORITY|||||||0.553|||||||ANCOVA|Within, within repeated measures ANVOA (gender as covariate)||||||0.553
91581940|NCT02552368|183053838|SUPERIORITY|||||||0.002|||||||Paired t-Test|||||||0.002
91581941|NCT02552368|183053839|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Performance COPM between Baseline and 12 weeks||||0.022
91646382|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5391|TWO_SIDED|95.0|0.54|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.21|0.54|0.5391
91776940|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|86.32||||0.002|TWO_SIDED|95.0|5.07|1468.36|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||1468.36|5.07|0.002
91776941|NCT05565742|183434844|SUPERIORITY||Odds Ratio (OR)|956.84|||<|0.001|TWO_SIDED|95.0|55.75|16422.76|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||16422.76|55.75|<0.001
91776942|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|32.05|||<|0.001|TWO_SIDED|95.0|5.36|191.58|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||191.58|5.36|<0.001
91776943|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|602.39|||<|0.001|TWO_SIDED|95.0|95.36|3805.22|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||3805.22|95.36|<0.001
91776944|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|6953.37|||<|0.001|TWO_SIDED|95.0|527.56|91646.24|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||91646.24|527.56|<0.001
91776945|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|347.76|||<|0.001|TWO_SIDED|95.0|57.46|2104.62|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||2104.62|57.46|<0.001
91776946|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|54.99||||0.007|TWO_SIDED|95.0|2.98|1015.84|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||1015.84|2.98|0.007
91776947|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|363.15|||<|0.001|TWO_SIDED|95.0|20.83|6332.68|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6332.68|20.83|<0.001
91776948|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|2953.53|||<|0.001|TWO_SIDED|95.0|150.95|57790.71|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||57790.71|150.95|<0.001
91776949|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|375.16|||<|0.001|TWO_SIDED|95.0|21.46|6571.66|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6571.66|21.46|<0.001
91776950|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|16.43||||0.068|TWO_SIDED|95.0|0.81|331.69|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||331.69|0.81|0.068
91646383|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0224|TWO_SIDED|95.0|1.1|3.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.53|1.10|0.0224
91776951|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|84.97||||0.002|TWO_SIDED|95.0|4.99|1447.48|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1447.48|4.99|0.002
91776952|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|594.66|||<|0.001|TWO_SIDED|95.0|33.99|10405.09|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||10405.09|33.99|<0.001
91776953|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|110.17||||0.001|TWO_SIDED|95.0|6.47|1875.77|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1875.77|6.47|0.001
91776954|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|11.61||||0.01|TWO_SIDED|95.0|1.81|74.29|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||74.29|1.81|0.010
91776955|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|233.25|||<|0.001|TWO_SIDED|95.0|39.92|1362.79|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||1362.79|39.92|<0.001
91776956|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|3087.58|||<|0.001|TWO_SIDED|95.0|331.26|28778.1|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||28778.10|331.26|<0.001
91776957|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|144.58|||<|0.001|TWO_SIDED|95.0|25.2|829.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||829.42|25.20|<0.001
91521031|NCT01984697|182916880|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.47|||<|0.001|TWO_SIDED|95.0|2.93|4.11|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.11|2.93|<0.001
91521032|NCT01984697|182916881|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.8|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.8|<0.001
91521033|NCT01984697|182916881|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
91521034|NCT01984697|182916881|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
91521035|NCT01984697|182916882|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.39|||<|0.001|TWO_SIDED|95.0|2.03|2.82|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.82|2.03|<0.001
91521036|NCT01984697|182916882|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.09|2.88|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.88|2.09|<0.001
91521037|NCT01984697|182916882|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|5.07|||<|0.001|TWO_SIDED|95.0|4.32|5.94|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.94|4.32|<0.001
91521038|NCT01984697|182916883|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.54|||<|0.001|TWO_SIDED|95.0|2.14|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.14|<0.001
91581942|NCT02552368|183053839|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks||||0.031
91646384|NCT01236053|183184706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.1815|TWO_SIDED|95.0|0.82|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.77|0.82|0.1815
91776958|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|11.16||||0.125|TWO_SIDED|95.0|0.51|243.85|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||243.85|0.51|0.125
91776959|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|148.3|||<|0.001|TWO_SIDED|95.0|8.64|2546.89|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2546.89|8.64|<0.001
91776960|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|1431.38|||<|0.001|TWO_SIDED|95.0|77.76|26349.86|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||26349.86|77.76|<0.001
91776961|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|147.78|||<|0.001|TWO_SIDED|95.0|8.6|2538.95|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2538.95|8.60|<0.001
91776962|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|1.99||||0.733|TWO_SIDED|95.0|0.04|104.02|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||104.02|0.04|0.733
91776963|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|34.28||||0.015|TWO_SIDED|95.0|1.98|594.46|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||594.46|1.98|0.015
91776964|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|159.77|||<|0.001|TWO_SIDED|95.0|9.4|2716.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||2716.42|9.40|<0.001
91521039|NCT01984697|182916883|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.29|3.15|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.15|2.29|<0.001
91708304|NCT01763827|183309603|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-58.5|-47.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-47.3|-58.5|<0.001
91708305|NCT01763827|183309604|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|64.4|80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||80.2|64.4|<0.001
91708306|NCT01763827|183309604|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.3|||<|0.001|TWO_SIDED|95.0|62.2|78.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.0|62.2|<0.001
91708307|NCT01763827|183309604|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|72.2|||<|0.001|TWO_SIDED|95.0|62.4|78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.9|62.4|<0.001
91708308|NCT01763827|183309604|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.6|||<|0.001|TWO_SIDED|95.0|58.3|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||75.5|58.3|<0.001
91708309|NCT01763827|183309605|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.2|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.2|<0.001
91708310|NCT01763827|183309605|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.4|||<|0.001|TWO_SIDED|95.0|55.6|72.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||72.9|55.6|<0.001
91708311|NCT01763827|183309605|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.3|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.3|<0.001
91708312|NCT01763827|183309605|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.0|||<|0.001|TWO_SIDED|95.0|53.5|71.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||71.6|53.5|<0.001
91708313|NCT01763827|183309606|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-52.01|-45.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.61|-52.01|<0.001
91708314|NCT01763827|183309606|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.28|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-56.23|-50.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.33|-56.23|<0.001
91708315|NCT01763827|183309606|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.58|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-38.79|-32.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.38|-38.79|<0.001
91708316|NCT01763827|183309606|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.49|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-38.44|-32.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.53|-38.44|<0.001
91708317|NCT01763827|183309607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.81|STANDARD_ERROR_OF_MEAN|1.79|<|0.001|TWO_SIDED|95.0|-53.34|-46.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-46.27|-53.34|<0.001
91708318|NCT01763827|183309607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.19|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-54.49|-47.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.90|-54.49|<0.001
91776965|NCT05565742|183434845|SUPERIORITY||Odds Ratio (OR)|37.98||||0.013|TWO_SIDED|95.0|2.19|659.75|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||659.75|2.19|0.013
91776966|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-47.4|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-59.9|-30.9|||Mixed Models Analysis|||Baseline to Day 60||-30.9|-59.9|<0.001
91776967|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-80.9|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-84.7|-76.1|||Mixed Models Analysis|||Baseline to Day 60||-76.1|-84.7|<0.001
91581943|NCT00911768|183053840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.416|<|0.05||95.0|-0.647|1.008|||t-test, 2 sided|||||1.008|-0.647|<0.05
91581944|NCT00911768|183053841|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.116|<|0.05||95.0|-0.576|-0.115|||t-test, 2 sided|||||-0.115|-0.576|<0.05
91581945|NCT00911768|183053842|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.035|<|0.05||95.0|-0.155|-0.017|||t-test, 2 sided|||||-0.017|-0.155|<0.05
91581946|NCT03406078|183053855|SUPERIORITY||Cumulative Odds Ratio|1.28||||0.434|TWO_SIDED|95.0|0.69|2.35|||Proportional odds model|Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region and daily OCS dose at baseline.||||2.35|0.69|0.434
91581947|NCT00467350|183053875|SUPERIORITY_OR_OTHER_LEGACY|"Similar to previous studies, the main outcome measure was the change in the child's main symptom. Changes were determined by the question Has your child's main symptom improved, stayed the same or gotten worse? The main symptom was defined as the chief complaint identified during the triage process. For analysis, responses were dichotomized into 2 groups: improved/better versus worse/same."|||||||||||||||||A χ2 test was used to examine the difference in probabilities of experiencing an outcome between treatment arms and differences were expressed by Mantel-Haenszel common OR estimate with 95% confidence interval (CI).|||
91581948|NCT03616977|183053891|EQUIVALENCE|Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.961|1.06||||||||1.06|0.961|
91613224|NCT01422304|183120832|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR) (%)|5.5|||||TWO_SIDED|95.0|3.7|7.3|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||7.3|3.7|
91613225|NCT01422304|183120832|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9||||||95.0|-0.9|2.8|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.8|-0.9|
91613226|NCT01422304|183120833|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|3.0|||||TWO_SIDED|95.0|1.3|4.7|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||4.7|1.3|
91646385|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0248|TWO_SIDED|95.0|1.12|5.09|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.09|1.12|0.0248
91776968|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
91613227|NCT01422304|183120833|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9|||||TWO_SIDED|95.0|-1.0|2.9|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.9|-1.0|
91646386|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.052|TWO_SIDED|95.0|0.99|4.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.70|0.99|0.0520
91776969|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
91776970|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|11.1||0.019|TWO_SIDED|95.0|-50.6|-6.2|||Mixed Models Analysis|||Baseline to Day 180||-6.2|-50.6|0.019
91776971|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-66.0|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-73.8|-55.9|||Mixed Models Analysis|||Baseline to Day 180||-55.9|-73.8|<0.001
91776972|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
91776973|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
91776974|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|8.25|<|0.001|TWO_SIDED|95.0|-61.3|-28.3|||Mixed Models Analysis|||Baseline to Day 240||-28.3|-61.3|<0.001
91776975|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-88.1|-80.3|||Mixed Models Analysis|||Baseline to Day 240||-80.3|-88.1|<0.001
91776976|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-96.8|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-97.4|-95.9|||Mixed Models Analysis|||Baseline to Day 240||-95.9|-97.4|<0.001
91776977|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-87.9|-80.8|||Mixed Models Analysis|||Baseline to Day 240||-80.8|-87.9|<0.001
91776978|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|11.45||0.029|TWO_SIDED|95.0|-49.4|-3.6|||Mixed Models Analysis|||Baseline to Day 360||-3.6|-49.4|0.029
91776979|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-67.4|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-74.9|-57.6|||Mixed Models Analysis|||Baseline to Day 360||-57.6|-74.9|<0.001
91776980|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-91.0|STANDARD_ERROR_OF_MEAN|1.11|<|0.001|TWO_SIDED|95.0|-92.9|-88.5|||Mixed Models Analysis|||Baseline to Day 360||-88.5|-92.9|<0.001
91613228|NCT01422304|183120834|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.6|||||TWO_SIDED|95.0|-3.0|1.8|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.8|-3.0|
91776981|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-67.8|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-74.8|-59.0|||Mixed Models Analysis|||Baseline to Day 360||-59.0|-74.8|<0.001
91776982|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-19.7|STANDARD_ERROR_OF_MEAN|10.45||0.093|TWO_SIDED|95.0|-37.8|3.7|||Mixed Models Analysis|||Baseline to Day 540||3.7|-37.8|0.093
91776983|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|-56.0|-33.2|||Mixed Models Analysis|||Baseline to Day 540||-33.2|-56.0|<0.001
91776984|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-74.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-78.8|-68.5|||Mixed Models Analysis|||Baseline to Day 540||-68.5|-78.8|<0.001
91776985|NCT05565742|183434846|SUPERIORITY||LS Mean difference (Final Values)|-53.4|STANDARD_ERROR_OF_MEAN|4.67|<|0.001|TWO_SIDED|95.0|-61.7|-43.3|||Mixed Models Analysis|||Baseline to Day 540||-43.3|-61.7|<0.001
91708319|NCT01763827|183309607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.23|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-38.74|-31.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.71|-38.74|<0.001
91776986|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.74||0.01|TWO_SIDED|95.0|-17.5|-2.6|||Mixed Models Analysis|||Baseline to Day 60||-2.6|-17.5|0.010
91776987|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-17.7|-5.8|||Mixed Models Analysis|||Baseline to Day 60||-5.8|-17.7|<0.001
91776988|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
91776989|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
91776990|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.27||0.068|TWO_SIDED|95.0|-16.2|0.6|||Mixed Models Analysis|||Baseline to Day 180||0.6|-16.2|0.068
91776991|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|3.4||0.003|TWO_SIDED|95.0|-17.1|-3.8|||Mixed Models Analysis|||Baseline to Day 180||-3.8|-17.1|0.003
91776992|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
91776993|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
91776994|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.93||0.026|TWO_SIDED|95.0|-16.7|-1.2|||Mixed Models Analysis|||Baseline to Day 240||-1.2|-16.7|0.026
91776995|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-21.1|-9.3|||Mixed Models Analysis|||Baseline to Day 240||-9.3|-21.1|<0.001
91776996|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-21.0|-9.6|||Mixed Models Analysis|||Baseline to Day 240||-9.6|-21.0|<0.001
91776997|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-16.3|-4.4|||Mixed Models Analysis|||Baseline to Day 240||-4.4|-16.3|<0.001
91776998|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|4.21||0.111|TWO_SIDED|95.0|-14.9|1.7|||Mixed Models Analysis|||Baseline to Day 360||1.7|-14.9|0.111
91613229|NCT01422304|183120835|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.4|||||TWO_SIDED|95.0|-3.4|0.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||0.5|-3.4|
91708320|NCT01763827|183309607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.21|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-36.51|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.90|-36.51|<0.001
91581949|NCT05398237|183053950|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0122||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK).|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0122
91581950|NCT05398237|183053950|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.009||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.009
91581951|NCT05398237|183053951|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0063||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0063
91581952|NCT05398237|183053951|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0056||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.0056
91581953|NCT04193436|183053969|OTHER||Ratio (%) of Adjusted Means|92.89|||||TWO_SIDED|90.0|68.15|126.6||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way analysis of variance (ANOVA) model based on natural log transformed data.||126.60|68.15|
91581954|NCT04193436|183053969|OTHER||Ratio (%) of Adjusted Means|134.4|||||TWO_SIDED|90.0|98.61|183.17||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||183.17|98.61|
91581955|NCT04193436|183053969|OTHER||Ratio (%) of Adjusted Means|139.33|||||TWO_SIDED|90.0|100.69|192.78||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||192.78|100.69|
91646387|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0046|TWO_SIDED|95.0|1.3|4.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.20|1.30|0.0046
91708321|NCT01763827|183309608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.09|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-50.67|-43.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-43.51|-50.67|<0.001
91776999|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-18.1|-5.3|||Mixed Models Analysis|||Baseline to Day 360||-5.3|-18.1|<0.001
91777000|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-20.0|-7.8|||Mixed Models Analysis|||Baseline to Day 360||-7.8|-20.0|<0.001
91581956|NCT04193436|183053970|OTHER||Ratio (%) of Adjusted Means|87.2|||||TWO_SIDED|90.0|63.61|119.53||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||119.53|63.61|
91777001|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|3.3||0.013|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||400 mg LY3819469, Placebo||-1.9|-14.9|0.013
91777002|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|4.2||0.51|TWO_SIDED|95.0|-10.7|5.8|||Mixed Models Analysis|||Baseline to Day 540||5.8|-10.7|0.510
91581957|NCT04193436|183053970|OTHER||Ratio (%) of Adjusted Means|102.24|||||TWO_SIDED|90.0|74.59|140.15||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||140.15|74.59|
91581958|NCT04193436|183053970|OTHER||Ratio (%) of Adjusted Means|83.78|||||TWO_SIDED|90.0|60.18|116.62||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||116.62|60.18|
91581959|NCT04193436|183053971|OTHER||Ratio (%) of Adjusted Means|121.81|||||TWO_SIDED|90.0|88.69|167.31||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||167.31|88.69|
91646388|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0193|TWO_SIDED|95.0|1.12|3.72|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.72|1.12|0.0193
91646389|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.75||||0.0309|TWO_SIDED|95.0|1.1|6.88|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||6.88|1.10|0.0309
91581960|NCT04193436|183053971|OTHER||Ratio (%) of Adjusted Means|178.5|||||TWO_SIDED|90.0|129.96|245.18||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||245.18|129.96|
91581961|NCT04193436|183053971|OTHER||Ratio (%) of Adjusted Means|195.73|||||TWO_SIDED|90.0|140.31|273.03||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||273.03|140.31|
91777003|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|3.35||0.173|TWO_SIDED|95.0|-11.1|2.1|||Mixed Models Analysis|||Baseline to Day 540||2.1|-11.1|0.173
91777004|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-18.6|-6.8|||Mixed Models Analysis|||Baseline to Day 540||-6.8|-18.6|<0.001
91777005|NCT05565742|183434847|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.27||0.139|TWO_SIDED|95.0|-11.2|1.7|||Mixed Models Analysis|||Baseline to Day 540||1.7|-11.2|0.139
91777006|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|16.71||0.353|TWO_SIDED|95.0|-44.3|23.3|||Mixed Models Analysis|||Baseline to Day 60||23.3|-44.3|0.353
91777007|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|15.84||0.902|TWO_SIDED|95.0|-28.7|34.7|||Mixed Models Analysis|||Baseline to Day 60||34.7|-28.7|0.902
91777008|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
91777009|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
91777010|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|20.41||0.987|TWO_SIDED|95.0|-32.8|49.7|||Mixed Models Analysis|||Baseline to Day 180||49.7|-32.8|0.987
91777011|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|13.96||0.316|TWO_SIDED|95.0|-38.7|17.2|||Mixed Models Analysis|||Baseline to Day 180||17.2|-38.7|0.316
91777012|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
91777013|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
91777014|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|14.66||0.461|TWO_SIDED|95.0|-36.1|22.6|||Mixed Models Analysis|||Baseline to Day 240||22.6|-36.1|0.461
91777015|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|11.29||0.194|TWO_SIDED|95.0|-35.6|9.4|||Mixed Models Analysis|||Baseline to Day 240||9.4|-35.6|0.194
91581962|NCT04193436|183053972|OTHER||Ratio (%) of Adjusted Means|114.45|||||TWO_SIDED|90.0|88.13|148.63||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||148.63|88.13|
91777016|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|12.87||0.898|TWO_SIDED|95.0|-24.0|27.2|||Mixed Models Analysis|||Baseline to Day 240||27.2|-24.0|0.898
91777017|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|11.81||0.448|TWO_SIDED|95.0|-29.9|17.0|||Mixed Models Analysis|||Baseline to Day 240||17.0|-29.9|0.448
91777018|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|28.05||0.233|TWO_SIDED|95.0|-15.4|98.4|||Mixed Models Analysis|||Baseline to Day 360||98.4|-15.4|0.233
91777019|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|18.04||0.891|TWO_SIDED|95.0|-27.6|44.9|||Mixed Models Analysis|||Baseline to Day 360||44.9|-27.6|0.891
91777020|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|17.18||0.984|TWO_SIDED|95.0|-29.0|39.9|||Mixed Models Analysis|||Baseline to Day 360||39.9|-29.0|0.984
91777021|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|19.4|STANDARD_ERROR_OF_MEAN|20.52||0.302|TWO_SIDED|95.0|-14.8|67.5|||Mixed Models Analysis|||Baseline to Day 360||67.5|-14.8|0.302
91777022|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|18.49||0.684|TWO_SIDED|95.0|-37.9|36.8|||Mixed Models Analysis|||Baseline to Day 540||36.8|-37.9|0.684
91777023|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|16.19||0.933|TWO_SIDED|95.0|-28.6|36.3|||Mixed Models Analysis|||Baseline to Day 540||36.3|-28.6|0.933
91581963|NCT04193436|183053972|OTHER||Ratio (%) of Adjusted Means|136.04|||||TWO_SIDED|90.0|104.75|176.67||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||176.67|104.75|
91613230|NCT01422304|183120836|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.9|||||TWO_SIDED|95.0|-3.1|1.2|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.2|-3.1|
91777024|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|16.33||0.962|TWO_SIDED|95.0|-26.7|38.6|||Mixed Models Analysis|||Baseline to Day 540||38.6|-26.7|0.962
91777025|NCT05565742|183434848|SUPERIORITY||LS Mean difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|18.52||0.422|TWO_SIDED|95.0|-17.2|56.9|||Mixed Models Analysis|||Baseline to Day 540||56.9|-17.2|0.422
91777026|NCT00335777|183434910|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||0.289|TWO_SIDED|95.0|||||McNemar|2 sided McNemar||Null hypothesis: there is no difference in the proportion of subjects who were pain free when treating early, as compared to treating late.||||0.289
91777027|NCT00335777|183434911|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||1|||||||McNemar|2 sided McNemar test||Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.||||1.000
91708322|NCT01763827|183309608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.93|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-54.27|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.59|-54.27|<0.001
91777028|NCT01074814|183434937|OTHER||||||||||||||||||Results for the primary objective - evaluation of GMI - were presented with descriptive statistics as the ration of PFS on current therapy over the PFS on latest therapy. The percentage of patients with GMI greater than 1.3 was displayed along with its corresponding 95% exact confidence interval.|||
91777029|NCT03175367|183434969|SUPERIORITY||Least Squares Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|-56.5|-20.6|||Mixed Models Analysis|||||-20.6|-56.5|< .0001
91777030|NCT03175367|183434969|SUPERIORITY||Least Squares Mean Difference|-52.9|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-70.7|-35.1|||Mixed Models Analysis|||||-35.1|-70.7|< .0001
91777031|NCT03175367|183434969|SUPERIORITY||Least Squares Mean Difference|-56.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-73.7|-38.3|||Mixed Models Analysis|||||-38.3|-73.7|< .0001
91777032|NCT03175367|183434969|SUPERIORITY||Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|9.3|=|0.0109|TWO_SIDED|95.0|-42.6|-5.7||P-Value is not adjusted for multiplicity|Mixed Models Analysis|||||-5.7|-42.6|= 0.0109
91777033|NCT03175367|183434969|SUPERIORITY||Least Squares Mean Difference|-50.5|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-68.4|-32.6|||Mixed Models Analysis|||||-32.6|-68.4|< .0001
91777034|NCT03175367|183434970|SUPERIORITY||Least Squares Mean Difference|-26.6|STANDARD_ERROR_OF_MEAN|7.2|=|0.0003|TWO_SIDED|95.0|-40.9|-12.4|||Mixed Models Analysis|||||-12.4|-40.9|= 0.0003
91777035|NCT03175367|183434970|SUPERIORITY||Least Squares Mean Difference|-42.0|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-56.1|-27.9|||Mixed Models Analysis|||||-27.9|-56.1|< 0.0001
91777036|NCT03175367|183434970|SUPERIORITY||Least Squares Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-59.5|-31.5|||Mixed Models Analysis|||||-31.5|-59.5|< 0.0001
91777037|NCT03175367|183434970|SUPERIORITY||Least Squares Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|6.6|=|0.0132|TWO_SIDED|95.0|-29.7|-3.5|||Mixed Models Analysis|||||-3.5|-29.7|= 0.0132
91777038|NCT03175367|183434970|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED|95.0|-52.0|-26.8|||Mixed Models Analysis|||||-26.8|-52.0|< 0.0001
91777039|NCT03175367|183434971|SUPERIORITY||Least Squares Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|8.4|=|0.0111|TWO_SIDED|95.0|-38.4|-5.1|||Mixed Models Analysis|||||-5.1|-38.4|= 0.0111
91777040|NCT03175367|183434971|SUPERIORITY||Least Squares Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|8.2|<|0.0001|TWO_SIDED|95.0|-56.7|-24.0|||Mixed Models Analysis|||||-24.0|-56.7|< 0.0001
91777041|NCT03175367|183434972|SUPERIORITY||Least Squares Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-54.4|-24.3|||Mixed Models Analysis|||||-24.3|-54.4|< 0.0001
91777042|NCT03175367|183434972|SUPERIORITY||Least Squares Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-68.8|-38.9|||Mixed Models Analysis|||||-38.9|-68.8|< 0.0001
91777043|NCT03175367|183434972|SUPERIORITY||Least Squares Mean Difference|-58.5|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|-73.4|-43.7|||Mixed Models Analysis|||||-43.7|-73.4|< 0.0001
91777044|NCT03175367|183434972|SUPERIORITY||Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|8.1|=|0.0042|TWO_SIDED|95.0|-39.7|-7.7|||Mixed Models Analysis|||||-7.7|-39.7|= 0.0042
91777045|NCT03175367|183434972|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-66.4|-35.4|||Mixed Models Analysis|||||-35.4|-66.4|< 0.0001
91521040|NCT01984697|182916883|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.54|||<|0.001|TWO_SIDED|95.0|3.84|5.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.37|3.84|<0.001
91521041|NCT01984697|182916884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.46|||<|0.001|TWO_SIDED|95.0|2.05|2.96|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.96|2.05|<0.001
91521042|NCT01984697|182916884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.04|2.92|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.92|2.04|<0.001
91521043|NCT01984697|182916884|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.69|||<|0.001|TWO_SIDED|95.0|3.06|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.06|<0.001
91521044|NCT01984697|182916885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.1|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.10|<0.001
91777046|NCT03175367|183434973|SUPERIORITY||Least Squares Mean Difference|-30.6|STANDARD_ERROR_OF_MEAN|9.7|=|0.0021|TWO_SIDED|95.0|-49.8|-11.4|||Mixed Models Analysis|||||-11.4|-49.8|= 0.0021
91777047|NCT03175367|183434973|SUPERIORITY||Least Squares Mean Difference|-54.6|STANDARD_ERROR_OF_MEAN|9.5|<|0.0001|TWO_SIDED|95.0|-73.4|-35.8|||Mixed Models Analysis|||||-35.8|-73.4|< 0.0001
91777048|NCT03175367|183434974|SUPERIORITY||Odds Ratio, log|19.4|||<|0.0001|TWO_SIDED|95.0|5.1|72.8|||Regression, Logistic|||||72.8|5.1|< 0.0001
91777049|NCT03175367|183434974|SUPERIORITY||Odds Ratio, log|23.9|||<|0.0001|TWO_SIDED|95.0|6.4|89.2|||Regression, Logistic|||||89.2|6.4|< 0.0001
91777050|NCT03175367|183434974|SUPERIORITY||Odds Ratio, log|22.1|||<|0.0001|TWO_SIDED|95.0|6.0|80.5|||Regression, Logistic|||||80.5|6.0|< 0.0001
91777051|NCT03175367|183434974|SUPERIORITY||Odds Ratio, log|8.5|||=|0.0007|TWO_SIDED|95.0|2.5|29.2|||Regression, Logistic|||||29.2|2.5|= 0.0007
91777052|NCT03175367|183434974|SUPERIORITY||Odds Ratio, log|42.3|||<|0.0001|TWO_SIDED|95.0|10.4|172.3|||Regression, Logistic|||||172.3|10.4|< 0.0001
91777053|NCT03175367|183434975|SUPERIORITY||Odds Ratio (OR)|9.6|||=|0.01|TWO_SIDED|95.0|1.7|53.5|||Regression, Logistic|||||53.5|1.7|= 0.0100
91777054|NCT03175367|183434975|SUPERIORITY||Odds Ratio (OR)|24.8|||=|0.0001|TWO_SIDED|95.0|4.7|129.9|||Regression, Logistic|||||129.9|4.7|= 0.0001
91581964|NCT04193436|183053972|OTHER||Ratio (%) of Adjusted Means|117.87|||||TWO_SIDED|90.0|89.61|155.03||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||155.03|89.61|
91581965|NCT01749904|183054004|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.|||||<|0.01||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol|ANCOVA|||||||<0.01
91581966|NCT01749904|183054005|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
91581967|NCT01749904|183054006|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
91581968|NCT01749904|183054007|OTHER||||||||||||||||||No statistical analysis was performed on these proportions.|||
91581969|NCT01383499|183054045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.023||0.0002|TWO_SIDED|95.0|0.042|0.132||First step of closed testing procedure, where the active treatments are compared to placebo. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R5 minus Placebo||0.132|0.042|0.0002
91581970|NCT01383499|183054045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.059|0.149||Second step of closed testing procedure. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R2.5 minus Placebo||0.149|0.059|<.0001
91581971|NCT01383499|183054045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.023||0.0011|TWO_SIDED|95.0|0.03|0.12|||Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.120|0.030|0.0011
91581972|NCT01383499|183054045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.034|0.057|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R1.25||0.057|-0.034|
91777055|NCT03175367|183434975|SUPERIORITY||Odds Ratio (OR)|36.1|||<|0.0001|TWO_SIDED|95.0|6.7|194.7|||Regression, Logistic|||||194.7|6.7|< 0.0001
91581973|NCT01383499|183054045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.063|0.028|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R2.5||0.028|-0.063|
91581974|NCT01383499|183054045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.016|0.074|||Mixed models repeated measures (MMRM)|||Tio R2.5 minus Tio R1.25||0.074|-0.016|
91581975|NCT02469389|183054079|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at BL (any difference was assumed due to random sampling error).||||||0.295|||||||Mixed Models Analysis|Post-hoc mixed effects model analyses of all outcomes were performed adjusting for BL CAINS MAP score.||Analyses of the primary and secondary outcomes utilized a linear mixed effects model accounting for random therapy group effects and included all available data at baseline (BL), post-treatment (PT; 12-week), and follow-up (FU; 24-week) timepoints (TPs). Error terms across TPs were assumed correlated with unstructured correlation matrix. To test time specific hypotheses, terms in the mean model included separate indicators for PT \& FU \& interaction terms between these indicators and conditions.||||0.295
91581976|NCT02469389|183054080|SUPERIORITY|||||||0.182|||||||Mixed Models Analysis|||||||0.182
91581977|NCT02469389|183054081|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|||||||0.114
91581978|NCT02469389|183054082|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.220
91581979|NCT02469389|183054083|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
91581980|NCT02469389|183054084|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
91581981|NCT02469389|183054085|SUPERIORITY|||||||0.535|||||||Mixed Models Analysis|||||||0.535
91581982|NCT02469389|183054086|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
91581983|NCT02469389|183054087|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||||||0.692
91581984|NCT02469389|183054088|SUPERIORITY|||||||0.498|||||||Mixed Models Analysis|||||||0.498
91581985|NCT02469389|183054089|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||0.079
91581986|NCT02469389|183054090|SUPERIORITY|||||||0.539|||||||Mixed Models Analysis|||||||0.539
91581987|NCT01079663|183054098|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1629|TWO_SIDED|95.0|-1.19|0.2|||Mixed Models Analysis|||||0.20|-1.19|0.1629
91581988|NCT01079663|183054099|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0347|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||||-0.06|-1.46|0.0347
91581989|NCT01014143|183054109|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91581990|NCT03536143|183054168|SUPERIORITY|||||||0.0216|||||||Log Rank|||||||0.0216
91581991|NCT03536143|183054169|SUPERIORITY|||||||0.0009|||||||Log Rank|||||||0.0009
91581992|NCT00523640|183054177|SUPERIORITY_OR_OTHER||Proportion responding|0.24|||||TWO_SIDED|95.0|0.1|0.44||||||||0.44|0.10|
91777056|NCT03175367|183434975|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.3185|TWO_SIDED|95.0|0.5|8.2|||Regression, Logistic|||||8.2|0.5|= 0.3185
91777057|NCT03175367|183434975|SUPERIORITY||Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|3.9|54.2|||Regression, Logistic|||||54.2|3.9|< 0.0001
91777058|NCT03175367|183434976|SUPERIORITY||Odds Ratio (OR)|4.8|||=|0.0718|TWO_SIDED|95.0|0.9|26.5|||Regression, Logistic|||||26.5|0.9|= 0.0718
91581993|NCT06377488|183054180|SUPERIORITY||least-square mean estimate|-0.085|STANDARD_ERROR_OF_MEAN|0.0139|||TWO_SIDED|95.0|-0.115|-0.056|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at distance was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||-0.056|-0.115|
91581994|NCT06377488|183054180|SUPERIORITY||least-square mean estimate|-0.023|STANDARD_ERROR_OF_MEAN|0.0131|||TWO_SIDED|95.0|-0.05|0.005|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at intermediate was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.005|-0.050|
91777059|NCT03175367|183434976|SUPERIORITY||Odds Ratio (OR)|11.4|||=|0.0048|TWO_SIDED|95.0|2.1|62.1|||Regression, Logistic|||||62.1|2.1|= 0.0048
91777060|NCT03175367|183434976|SUPERIORITY||Odds Ratio (OR)|14.7|||=|0.0015|TWO_SIDED|95.0|2.8|76.8|||Regression, Logistic|||||76.8|2.8|= 0.0015
91777061|NCT03175367|183434976|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.527|TWO_SIDED|95.0|0.3|8.4|||Regression, Logistic|||||8.4|0.3|= 0.5270
91777062|NCT03175367|183434976|SUPERIORITY||Odds Ratio (OR)|7.7|||=|0.0047|TWO_SIDED|95.0|1.9|31.7|||Regression, Logistic|||||31.7|1.9|= 0.0047
91777063|NCT03175367|183434977|SUPERIORITY||Least Squares Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|11.5|=|0.0059|TWO_SIDED|95.0|-55.5|-9.6|||Mixed Models Analysis|||||-9.6|-55.5|= 0.0059
91777064|NCT03175367|183434977|SUPERIORITY||Least Squares Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|11.3|<|0.0001|TWO_SIDED|95.0|-77.0|-32.0|||Mixed Models Analysis|||||-32.0|-77.0|< 0.0001
91581995|NCT06377488|183054180|SUPERIORITY||least-square mean estimate|0.083|STANDARD_ERROR_OF_MEAN|0.0152|||TWO_SIDED|95.0|0.051|0.116|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at near was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.116|0.051|
91777065|NCT03175367|183434978|SUPERIORITY||Least Squares Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|5.7|<|0.0001|TWO_SIDED|95.0|-48.4|-25.8|||Mixed Models Analysis|||||-25.8|-48.4|< .0001
91777066|NCT03175367|183434978|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-57.5|-35.2|||Mixed Models Analysis|||||-35.2|-57.5|< .0001
91777067|NCT03175367|183434978|SUPERIORITY||Least Squares Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||||-40.4|-62.5|< .0001
91777068|NCT03175367|183434978|SUPERIORITY||Least Squares Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.2|=|0.0006|TWO_SIDED|95.0|-34.6|-9.8|||Mixed Models Analysis|||||-9.8|-34.6|= 0.0006
91777069|NCT03175367|183434978|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|6.1|<|0.0001|TWO_SIDED|95.0|-58.4|-34.4|||Mixed Models Analysis|||||-34.4|-58.4|< .0001
91777070|NCT03175367|183434979|SUPERIORITY||Least Squares Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|7.1|=|0.0001|TWO_SIDED|95.0|-42.6|-14.3|||Mixed Models Analysis|||||-14.3|-42.6|= 0.0001
91777071|NCT03175367|183434979|SUPERIORITY||Least Squares Mean Difference|-49.3|STANDARD_ERROR_OF_MEAN|7.0|<|0.0001|TWO_SIDED|95.0|-63.2|-35.4|||Mixed Models Analysis|||||-35.4|-63.2|< .0001
91777072|NCT03175367|183434980|SUPERIORITY||Adjusted Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|6.0|<|0.0001|TWO_SIDED|95.0|-57.8|-34.3|||Regression, Linear|||||-34.3|-57.8|< .0001
91777073|NCT03175367|183434980|SUPERIORITY||Adjusted Mean Difference|-55.8|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-67.3|-44.3|||Regression, Linear|||||-44.3|-67.3|< .0001
91777074|NCT03175367|183434980|SUPERIORITY||Adjusted Mean Difference|-61.5|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-72.9|-50.0|||Regression, Linear|||||-50.0|-72.9|< .0001
91777075|NCT03175367|183434980|SUPERIORITY||Adjusted Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|6.5|=|0.0001|TWO_SIDED|95.0|-38.0|-12.4|||Regression, Linear|||||-12.4|-38.0|= 0.0001
91777076|NCT03175367|183434980|SUPERIORITY||Adjusted Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-58.4|-33.5|||Regression, Linear|||||-33.5|-58.4|< .0001
91777077|NCT03175367|183434981|SUPERIORITY||Adjusted Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.5|=|0.0228|TWO_SIDED|95.0|-31.8|-2.4|||Regression, Linear|||||-2.4|-31.8|= 0.0228
91777078|NCT03175367|183434981|SUPERIORITY||Adjusted Mean Difference|-45.3|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-59.6|-31.0|||Regression, Linear|||||-31.0|-59.6|< .0001
91777079|NCT03175367|183434982|SUPERIORITY||Adjusted Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|5.7|=|0.0635|TWO_SIDED|95.0|-21.8|0.6|||Regression, Linear|||||0.6|-21.8|= 0.0635
91777080|NCT03175367|183434982|SUPERIORITY||Adjusted Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|5.5|=|0.0314|TWO_SIDED|95.0|-22.8|-1.1|||Regression, Linear|||||-1.1|-22.8|= 0.0314
91777081|NCT03175367|183434982|SUPERIORITY||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|5.5|=|0.0923|TWO_SIDED|95.0|-19.9|1.5|||Regression, Linear|||||1.5|-19.9|= 0.0923
91777082|NCT03175367|183434982|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|5.3|=|0.0017|TWO_SIDED|95.0|-26.8|-6.2|||Regression, Linear|||||-6.2|-26.8|= 0.0017
91777083|NCT03175367|183434982|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|4.9|=|0.0009|TWO_SIDED|95.0|-26.2|-6.8|||Regression, Linear|||||-6.8|-26.2|= 0.0009
91777084|NCT03175367|183434983|SUPERIORITY||Adjusted Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|5.8|=|0.0054|TWO_SIDED|95.0|-27.4|-4.7|||Regression, Linear|||||-4.7|-27.4|= 0.0054
91777085|NCT03175367|183434983|SUPERIORITY||Adjusted Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|5.5|=|0.0085|TWO_SIDED|95.0|-25.4|-3.7|||Regression, Linear|||||-3.7|-25.4|= 0.0085
91777086|NCT02851615|183434984|SUPERIORITY|Power analyses were calculated on the PAM-13, our primary outcome measure. Analyses were conducted using the internal Monte Carlo simulation capabilities of Mplus (Version 1.20). Based on the effect size obtained from published pilot data, we expected the change in baseline/posttreatment Behavioral Activation for the SCThrive intervention group to be n2 = .14 (large effect). Based on these assumptions, the desired sample size was 54 participants (N = 27 per group) to achieve power of .80.|Mean Difference (Net)|7.75|STANDARD_ERROR_OF_MEAN|13.14||0.09|TWO_SIDED|95.0|-1.27|19.22||The threshold for statistical significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the PAM-13.||19.22|-1.27|.09
91777087|NCT02851615|183434985|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.55||0.28|TWO_SIDED|95.0|-0.19|0.66||The threshold for significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the TRAQ-5||.66|-.19|.28
91777088|NCT02851615|183434986|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13||0.27|TWO_SIDED|95.0|-0.018|0.06||The threshold for statistical significance was p =.05|t-test, 2 sided|||We conducted a paired-samples t-test to assess for the effects of time (baseline/post-treatment) for participants (n=16) in the SCThrive intervention arm for the UNC TRxANSITION Scale.||.06|-.018|.27
91777089|NCT02345070|183434997|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.05|=|0.6339|TWO_SIDED|95.0|-2.56|1.56||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg qw versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||1.56|-2.56|= 0.6339
91777090|NCT02345070|183434997|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.04|=|0.5874|TWO_SIDED|95.0|-1.47|2.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg q2w versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was performed sequentially in the order outcome measures were reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||2.6|-1.47|= 0.5874
91777091|NCT02151058|183435000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659|STANDARD_ERROR_OF_MEAN|0.0999|<|0.001|TWO_SIDED|95.0|-0.8559|-0.4622||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4622|-0.8559|<0.001
91777092|NCT02151058|183435000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.993|STANDARD_ERROR_OF_MEAN|0.1005|<|0.001|TWO_SIDED|95.0|-1.1909|-0.7946||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.7946|-1.1909|<0.001
91777093|NCT02151058|183435000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.0812|<|0.001|TWO_SIDED|95.0|-0.4937|-0.1737||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1737|-0.4937|<0.001
91777094|NCT02151058|183435001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|STANDARD_ERROR_OF_MEAN|0.0809|<|0.001|TWO_SIDED|95.0|-0.445|-0.1263||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1263|-0.4450|<0.001
91777095|NCT02151058|183435001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.0811|<|0.001|TWO_SIDED|95.0|-0.4877|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.4877|<0.001
91777096|NCT02151058|183435001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0653||0.52|TWO_SIDED|95.0|-0.1709|0.0866||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0866|-0.1709|0.520
91777097|NCT02151058|183435002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.0971|<|0.001|TWO_SIDED|95.0|-0.7043|-0.3217||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3217|-0.7043|<0.001
91613231|NCT01422304|183120837|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|0.3|||||TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.5|-0.7|
91581996|NCT06377488|183054181|SUPERIORITY||Mean Population Estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
91581997|NCT06377488|183054181|SUPERIORITY||Mean Population Estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
91581998|NCT06377488|183054182|SUPERIORITY||Central Posterior Mean Estimate|0.943|STANDARD_DEVIATION|0.0155|||TWO_SIDED|95.0|0.908|0.968|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.902 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.968|0.908|
91581999|NCT06377488|183054183|SUPERIORITY||Central Posterior Mean Estimate|0.988|STANDARD_DEVIATION|0.0058|||TWO_SIDED|95.0|0.974|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.997|0.974|
91582000|NCT06377488|183054184|SUPERIORITY||Central Posterior Mean Estimate|0.006|STANDARD_DEVIATION|0.0047|||TWO_SIDED|95.0|0.0|0.017|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.017|0.000|
91582001|NCT06377488|183054185|SUPERIORITY||Central Posterior Mean Estimate|0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|0.0|0.011|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.011|0.000|
91582002|NCT06377488|183054186|SUPERIORITY||Least-square mean estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for hyperopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
91582003|NCT06377488|183054186|SUPERIORITY||Least-square mean estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for myopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
91582004|NCT06377488|183054187|SUPERIORITY||Mean Population Estimate|64.7|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|58.6|70.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||70.8|58.6|
91582005|NCT06377488|183054187|SUPERIORITY||Mean Population Estimate|64.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|59.0|69.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||69.5|59.0|
91582006|NCT06377488|183054188|SUPERIORITY||Mean Population Estimate|67.9|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|62.2|73.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||73.5|62.2|
91777098|NCT02151058|183435002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.0975|<|0.001|TWO_SIDED|95.0|-0.877|-0.4925||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4925|-0.8770|<0.001
91777099|NCT02151058|183435002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.0786||0.03|TWO_SIDED|95.0|-0.3268|-0.0168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0168|-0.3268|0.030
91777100|NCT02151058|183435003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0369||0.026|TWO_SIDED|95.0|-0.1556|-0.0102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0102|-0.1556|0.026
91777101|NCT02151058|183435003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|STANDARD_ERROR_OF_MEAN|0.0372||0.002|TWO_SIDED|95.0|-0.1917|-0.0451||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0451|-0.1917|0.002
91777102|NCT02151058|183435003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.0297||0.234|TWO_SIDED|95.0|-0.094|0.0231||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0231|-0.0940|0.234
91777103|NCT02151058|183435004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.0568||0.002|TWO_SIDED|95.0|-0.2882|-0.0644||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0644|-0.2882|0.002
91777104|NCT02151058|183435004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.0573|<|0.001|TWO_SIDED|95.0|-0.4638|-0.2378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2378|-0.4638|<0.001
91777105|NCT02151058|183435004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.0458|<|0.001|TWO_SIDED|95.0|-0.2648|-0.0841||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0841|-0.2648|<0.001
91777106|NCT02151058|183435005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.0631|<|0.001|TWO_SIDED|95.0|-0.3713|-0.1226||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||Treatment and baseline value as covariates.||-0.1226|-0.3713|<0.001
91777107|NCT02151058|183435005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.498|STANDARD_ERROR_OF_MEAN|0.0638|<|0.001|TWO_SIDED|95.0|-0.6236|-0.3722||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3722|-0.6236|<0.001
91777108|NCT02151058|183435005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.0511|<|0.001|TWO_SIDED|95.0|-0.3516|-0.1503||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1503|-0.3516|<0.001
91777109|NCT02151058|183435006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0372||0.001|TWO_SIDED|95.0|-0.197|-0.0504||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0504|-0.1970|0.001
91777110|NCT02151058|183435006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.0373|<|0.001|TWO_SIDED|95.0|-0.2413|-0.0941||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0941|-0.2413|<0.001
91777111|NCT02151058|183435006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.0301||0.145|TWO_SIDED|95.0|-0.1034|0.0152||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0152|-0.1034|0.145
91777112|NCT02151058|183435007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.0497|<|0.001|TWO_SIDED|95.0|-0.3282|-0.1321||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1321|-0.3282|<0.001
91521045|NCT01984697|182916885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.2|3.12|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.12|2.20|<0.001
91777113|NCT02151058|183435007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4113|-0.2141||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2141|-0.4113|<0.001
91777114|NCT02151058|183435007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0404||0.042|TWO_SIDED|95.0|-0.1621|-0.0031||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0031|-0.1621|0.042
91777115|NCT02151058|183435008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.275|STANDARD_ERROR_OF_MEAN|0.0543|<|0.001|TWO_SIDED|95.0|-0.382|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.3820|<0.001
91708323|NCT01763827|183309608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.57|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-37.15|-29.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.99|-37.15|<0.001
91708324|NCT01763827|183309608|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.64|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-37.99|-31.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.28|-37.99|<0.001
91708325|NCT01763827|183309609|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.81|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-51.56|-44.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.05|-51.56|<0.001
91708326|NCT01763827|183309609|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.43|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-52.07|-44.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.79|-52.07|<0.001
91708327|NCT01763827|183309609|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.04|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-37.78|-30.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.30|-37.78|<0.001
91708328|NCT01763827|183309609|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.57|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-36.21|-28.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-28.92|-36.21|<0.001
91708329|NCT01763827|183309610|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.93|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-42.0|-35.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-35.86|-42.00|<0.001
91708330|NCT01763827|183309610|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.83|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-49.39|-42.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-42.27|-49.39|<0.001
91708331|NCT01763827|183309610|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-32.43|-26.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-26.28|-32.43|<0.001
91708332|NCT01763827|183309610|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.51|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-31.08|-23.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-23.94|-31.08|<0.001
91708333|NCT01763827|183309611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.63|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-42.97|-36.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-36.30|-42.97|<0.001
91708334|NCT01763827|183309611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.67|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-48.66|-40.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-40.68|-48.66|<0.001
91708335|NCT01763827|183309611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-31.73|-25.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-25.10|-31.73|<0.001
91708336|NCT01763827|183309611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.31|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-29.31|-21.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-21.31|-29.31|<0.001
91708337|NCT01763827|183309612|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.12|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-53.12|-45.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.12|-53.12|<0.001
91777116|NCT02151058|183435008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_ERROR_OF_MEAN|0.0548|<|0.001|TWO_SIDED|95.0|-0.5724|-0.3565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3565|-0.5724|<0.001
91777117|NCT02151058|183435008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.0442|<|0.001|TWO_SIDED|95.0|-0.2767|-0.1023||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1023|-0.2767|<0.001
91613232|NCT01422304|183120839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-45.0|30.5|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.||30.5|-45.0|
91777118|NCT01181349|183435010|SUPERIORITY_OR_OTHER||||||=|0.169|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.169
91777119|NCT01181349|183435012|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.01
91777120|NCT00321620|183435014|NON_INFERIORITY_OR_EQUIVALENCE|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82||||0.0002||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)|||0.95|0.71|0.0002
91777121|NCT00321620|183435015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0085||95.0|0.71|0.95|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.95|0.71|0.0085
91777122|NCT00321620|183435016|SUPERIORITY_OR_OTHER||Rate ratio|0.82||||0.0085||95.0|0.71|0.94|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.94|0.71|0.0085
91777123|NCT02399163|183435097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.76|||<|0.0001|TWO_SIDED|95.0|11.061|22.454||From ANOVA: participant (random), treatment (fixed), period (fixed)|ANCOVA||Difference is Placebo dentifrice/Fluoride rinse minus Placebo dentifrice/No rinse such that a positive difference implies a larger response value for the Placebo dentifrice/Fluoride rinse.|||22.454|11.061|<0.0001
91777124|NCT04613362|183435152|SUPERIORITY||Odds Ratio (OR)|0.82||||0.61|TWO_SIDED|95.0|0.34|1.97||adjusted for gender which is included as a covariate|Mixed Models Analysis|||||1.97|0.34|0.61
91777125|NCT04613362|183435154|SUPERIORITY||Mean Difference (Net)|-8.8028|STANDARD_ERROR_OF_MEAN|6.3895||0.1724|TWO_SIDED|95.0|-21.5314|3.9257|||Mixed Models Analysis|||3 month||3.9257|-21.5314|0.1724
91777126|NCT04613362|183435154|SUPERIORITY||Mean Difference (Net)|-4.6533|STANDARD_ERROR_OF_MEAN|5.9929||0.4399|TWO_SIDED|95.0|-16.5917|7.2851|||Mixed Models Analysis|||6 months||7.2851|-16.5917|0.4399
91777127|NCT04613362|183435155|SUPERIORITY||Mean Difference (Net)|18.7886|STANDARD_ERROR_OF_MEAN|18.0826||0.3021|TWO_SIDED|95.0|-17.2261|54.8032|||Mixed Models Analysis|||3 months||54.8032|-17.2261|0.3021
91777128|NCT04613362|183435155|SUPERIORITY||Mean Difference (Net)|-5.1996|STANDARD_ERROR_OF_MEAN|17.1338||0.7624|TWO_SIDED|95.0|-39.3245|28.9254|||Mixed Models Analysis|||6 months||28.9254|-39.3245|0.7624
91613233|NCT01422304|183120840|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-2.7|||||TWO_SIDED|95.0|-7.4|2.0|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site|Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site||2.0|-7.4|
91613234|NCT01422304|183120841|SUPERIORITY_OR_OTHER_LEGACY||GMR|1.1|||||TWO_SIDED|95.0|0.98|1.24|||Generalized Linear Model||GMR is Sugammadex versus Usual Care|Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.||1.24|0.98|
91613235|NCT01422304|183120842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.||3.1|-0.4|
91777129|NCT04613362|183435156|SUPERIORITY||Mean Difference (Net)|5.9613|STANDARD_ERROR_OF_MEAN|4.3867||0.1783|TWO_SIDED|95.0|-2.7794|14.7019|||Mixed Models Analysis|||3 months||14.7019|-2.7794|0.1783
91777130|NCT04613362|183435156|SUPERIORITY||Mean Difference (Net)|-0.2145|STANDARD_ERROR_OF_MEAN|4.1565||0.959|TWO_SIDED|95.0|-8.4965|8.0675|||Mixed Models Analysis|||6 months||8.0675|-8.4965|0.959
91777131|NCT04613362|183435157|SUPERIORITY||Mean Difference (Net)|-12.6627|STANDARD_ERROR_OF_MEAN|7.3097||0.0873|TWO_SIDED|95.0|-27.2243|1.8989|||Mixed Models Analysis|||3 months||1.8989|-27.2243|0.0873
91777132|NCT04613362|183435157|SUPERIORITY||Mean Difference (Net)|-7.3578|STANDARD_ERROR_OF_MEAN|6.8559||0.2866|TWO_SIDED|95.0|-21.0154|6.2999|||Mixed Models Analysis|||6 months||6.2999|-21.0154|0.2866
91777133|NCT04613362|183435159|SUPERIORITY||Mean Difference (Net)|-1.5655|STANDARD_ERROR_OF_MEAN|1.4313||0.2776|TWO_SIDED|95.0|-4.4168|1.2859|||Mixed Models Analysis|||3 months||1.2859|-4.4168|0.2776
91777134|NCT04613362|183435159|SUPERIORITY||Mean Difference (Net)|0.7202|STANDARD_ERROR_OF_MEAN|1.6492||0.6636|TWO_SIDED|95.0|-2.5651|4.0055|||Mixed Models Analysis|||6 months||4.0055|-2.5651|0.6636
91777135|NCT04613362|183435160|SUPERIORITY||Mean Difference (Net)|2.3254|STANDARD_ERROR_OF_MEAN|1.6911||0.1733|TWO_SIDED|95.0|-1.0443|5.695|||Mixed Models Analysis|||3 months||5.695|-1.0443|0.1733
91777136|NCT04613362|183435160|SUPERIORITY||Mean Difference (Net)|-0.5408|STANDARD_ERROR_OF_MEAN|1.622||0.7398|TWO_SIDED|95.0|-3.7726|2.6911|||Mixed Models Analysis|||6 months||2.6911|-3.7726|0.7398
91777137|NCT04613362|183435161|SUPERIORITY||Mean Difference (Net)|-0.1491|STANDARD_ERROR_OF_MEAN|1.5551||0.9239|TWO_SIDED|95.0|-3.2476|2.9494|||Mixed Models Analysis|||Physical Component Scale - 3 months||2.9494|-3.2476|0.9239
91777138|NCT04613362|183435161|SUPERIORITY||Mean Difference (Net)|-0.2879|STANDARD_ERROR_OF_MEAN|1.4735||0.8456|TWO_SIDED|95.0|-3.2238|2.6481|||Mixed Models Analysis|||Physical Component Scale - 6 months||2.6481|-3.2238|0.8456
91777139|NCT04613362|183435161|SUPERIORITY||Mean Difference (Net)|-0.1757|STANDARD_ERROR_OF_MEAN|2.3798||0.9413|TWO_SIDED|95.0|-4.9175|4.5661|||Mixed Models Analysis|||Mental Component Scale - 3 months||4.5661|-4.9175|0.9413
91777140|NCT04613362|183435161|SUPERIORITY||Mean Difference (Net)|-2.9597|STANDARD_ERROR_OF_MEAN|2.2549||0.1934|TWO_SIDED|95.0|-7.4526|1.5333|||Mixed Models Analysis|||Mental Component Scale - 6 months||1.5333|-7.4526|0.1934
91777141|NCT04613362|183435162|SUPERIORITY||Mean Difference (Net)|3.0999|STANDARD_ERROR_OF_MEAN|2.1004||0.1442|TWO_SIDED|95.0|-1.0852|7.2849|||Mixed Models Analysis|||3 months||7.2849|-1.0852|0.1442
91777142|NCT04613362|183435162|SUPERIORITY||Mean Difference (Net)|2.0675|STANDARD_ERROR_OF_MEAN|2.036||0.3132|TWO_SIDED|95.0|-1.9892|6.1243|||Mixed Models Analysis|||6 months||6.1243|-1.9892|0.3132
91777143|NCT04225897|183435197|OTHER||Difference|-8.02|||||TWO_SIDED|95.0|-31.78|15.74||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||15.74|-31.78|
91777144|NCT04225897|183435197|OTHER||Difference|-15.22|||||TWO_SIDED|95.0|-40.15|9.7|||Mixed effects analysis of covariance|||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||9.70|-40.15|
91777145|NCT04225897|183435198|OTHER||Difference|14.82|||||TWO_SIDED|95.0|-91.68|121.33||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||121.33|-91.68|
91777146|NCT04225897|183435198|OTHER||Difference|-31.19|||||TWO_SIDED|95.0|-143.96|81.57||||||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||81.57|-143.96|
91777147|NCT05172128|183435243|OTHER||||||>|0.05|||||||t-test, 2 sided||||Paired t-test comparing baseline value to endpoint value revealed a p-value of 0.80.|||>0.05
91777148|NCT05172128|183435244|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91777149|NCT05172128|183435245|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91777150|NCT05172128|183435246|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91777151|NCT05172128|183435249|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91777152|NCT01921205|183435257|SUPERIORITY||Percent reduction over Placebo|31.72|||=|0.0003|TWO_SIDED|95.0|16.342|44.277|||ANCOVA|Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.|Percent reduction over placebo is estimated as 100 x (1-exp\[LSMLacosamide-LSMPlacebo\]). Where LSM is Least Square Mean.|||44.277|16.342|=0.0003
91777153|NCT03137381|183435278|SUPERIORITY|||||||0.177|||||||Chi-squared|||||||0.177
91777154|NCT03137381|183435278|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91777155|NCT03137381|183435278|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91777156|NCT01684917|183435280|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
91777157|NCT01684917|183435280|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
91777158|NCT01684917|183435281|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
91777159|NCT01684917|183435282|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
91777160|NCT01684917|183435283|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
91582007|NCT06377488|183054188|SUPERIORITY||Mean Population Estimate|67.0|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|62.2|71.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||71.8|62.2|
91613236|NCT01422304|183120843|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||3.1|-6.3|
91777161|NCT01684917|183435283|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
91777162|NCT01684917|183435283|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
91777163|NCT01684917|183435285|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
91777164|NCT00459316|183435289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Two-sided p-value \<0.05 was specified as statistically significant a priori. There were no adjustments for multiple outcomes.|Fisher Exact|||The null hypothesis was that there would be no difference between CD4% strata.||||0.03
91777165|NCT00459316|183435290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||Two sided-p-value \<0.05 was specified as statistically significant a priori. No adjustment for multiple primary outcomes was made.|Fisher Exact|||The null hypothesis was that there were no differences between CD4% strata.||||0.01
91777166|NCT00423579|183435326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.5||||0||95.0|-18.9|-10.1|||Student's t test for independent data||Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe \[EZ\]/Simvastatin \[S\] \[10/20mg\] + S \[placebo\] group minus the EZ/S \[10mg/placebo\] + S \[40mg\] group)|||-10.1|-18.9|0.0000
91777167|NCT03873116|183435339|SUPERIORITY||negative binomial regression model|-24.6||||0.181|TWO_SIDED|95.0|-50.1|14.0|||negative binomial regression model|||||14.0|-50.1|0.181
91777168|NCT03873116|183435339|SUPERIORITY||negative binomial regression model|-49.1||||0.003|TWO_SIDED|95.0|-67.5|-20.4|||negative binomial regression model|||||-20.4|-67.5|0.003
91777169|NCT03873116|183435342|SUPERIORITY||Difference in Least Square Means|0.018||||0.814|TWO_SIDED|95.0|-0.143|0.179|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.179|-0.143|0.814
91777170|NCT03873116|183435342|SUPERIORITY||Difference in Least Square Means|-0.122||||0.12|TWO_SIDED|95.0|-0.28|0.036|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.036|-0.280|0.120
91777171|NCT03873116|183435343|SUPERIORITY||mixed-model repeated measures analysis|24.5||||0.188|TWO_SIDED|95.0|-14.7|50.3|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||50.3|-14.7|0.188
91777172|NCT03873116|183435343|SUPERIORITY||mixed-model repeated measures analysis|47.6||||0.005|TWO_SIDED|95.0|17.7|66.6|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||66.6|17.7|0.005
91777173|NCT03873116|183435344|SUPERIORITY||mixed-model repeated measures analysis|-12.65||||0.213|TWO_SIDED|95.0|-33.33|8.03|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||8.03|-33.33|0.213
91777174|NCT03873116|183435344|SUPERIORITY||mixed-model repeated measures analysis|-19.0||||0.061|TWO_SIDED|95.0|-39.0|0.99|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||0.99|-39.00|0.061
91777175|NCT02559622|183435424|SUPERIORITY||Least Square (LS) mean difference|1.17||||0.223|TWO_SIDED|95.0|-0.72|3.06|||ANCOVA|||||3.06|-0.72|0.2230
91777176|NCT00979940|183435462|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
91777177|NCT01668784|183435463|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0018|TWO_SIDED|98.52|0.57|0.93||The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.|Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.|||0.93|0.57|0.0018
91777178|NCT01668784|183435467|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.034|TWO_SIDED|95.0|0.72|0.99|||Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.|||0.99|0.72|0.0340
91777179|NCT01668784|183435473|SUPERIORITY||Stratified Cox Proportional hazard Model|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Log Rank|||||0.86|0.63|0.0001
91777180|NCT02761330|183435474|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
91582008|NCT06377488|183054189|SUPERIORITY||Central Posterior Mean Estimate|0.966|STANDARD_DEVIATION|0.0135|||TWO_SIDED|95.0|0.933|0.988|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data.||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70 with 5000 replicating trials, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.988|0.933|
91582009|NCT02926898|183054192|SUPERIORITY||Percent difference|-54.0|||<|0.001|TWO_SIDED|95.0|-67.2|-35.6||Analysis of covariance (ANCOVA) model with treatment group (ZX008 or placebo) and age group (\< 6 years, ≥ 6 years) as factors, and with log baseline frequency as a covariate, and log CSF as the outcome variable.|ANCOVA|||||-35.6|-67.2|<0.001
91582010|NCT02926898|183054193|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|A logistic regression model using a categorical response variable as a function of Treatment group, Baseline seizure frequency, and age group.||||||<0.001
91582011|NCT02926898|183054194|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91582012|NCT00116337|183054201|OTHER|Statistical analyses was performed using a repeated measures analysis of variance and Paired t test. A p value of \< 0.05 was taken as indicating statistical significance.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.||||<0.05
91582013|NCT00116337|183054203|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P\<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.||||<0.05
91582014|NCT02054741|183054224|SUPERIORITY||Risk Ratio (RR)|0.74||||0.0001|TWO_SIDED|95.0|0.64|0.86|||Mixed Models Analysis|Generalized Linear Mixed Model||||0.86|0.64|0.0001
91582015|NCT02054741|183054225|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.39|TWO_SIDED|95.0|0.85|1.5|||Regression, Cox|||||1.50|0.85|0.39
91582016|NCT02054741|183054226|SUPERIORITY||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.06|1.78|||Mixed Models Analysis|Generalized Linear Mixed Model||||1.78|1.06|0.015
91582017|NCT02344004|183054250|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving culture conversion by Month 6 was analyzed using the Cochran-Mantel-Haenszel test, stratified by smoking status and prior multi-drug regimen. The treatment comparison was tested at two-sided significance level of 0.05. The null hypothesis assumed that culture conversion by Month 6 is independent of treatment, and the alternative hypothesis assumed that culture conversion by Month 6 is associated with treatment.|The final analysis of the primary endpoint, the number of participants achieving culture conversion at by Month 6, was performed after the last participants completed Month 6 and his/her Month 6 sputum culture result was available.|||<0.0001
91582018|NCT02344004|183054251|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91582019|NCT02344004|183054252|SUPERIORITY|||||||0.7804|||||||Mixed Model Repeated Measures (MMRM)|||This was analyzed using a mixed model repeated measures (MMRM) analysis of change from Baseline at Months 4\&6. MMRM included treatment, month, treatment-by-month interaction, combination of smoking status \& prior MDR (4 levels: Yes/Yes, Yes/No, No/Yes, and No/No) as fixed factors, baseline 6MWD as a covariate \& baseline 6MWD-by-month interaction. An unstructured covariance matrix was used for the MMRM.|"* Baseline is defined as the last non-missing value prior to first dose of study drug.~* Statistics were obtained from an mixed-effects model repeated measures (MMRM) model with pattern-mixture modeling of missing values due to dropout, which included treatment, month, the treatment-by-month interaction, and the combination of smoking status and prior multidrug regimen as fixed factors, the baseline 6MWT distance as a covariate and baseline 6MWT distance-by-month interaction. MMRM included postbaseline data through Month 6.~* For baseline, n is the number of participants with a baseline score and at least 1 postbaseline score. For Month 6, n is the number of participants with a baseline score and a postbaseline score at the summarized visit."|||0.7804
91582020|NCT02344004|183054253|SUPERIORITY||Cox Proportional Hazard|3.92|||<|0.0001|TWO_SIDED|95.0|2.01|7.63|||Regression, Cox|||Kaplan Meier estimates for the distribution of time to culture conversion were constructed for treatment arms. The treatment comparison was made using the stratified log rank test for the ITT population. The estimated median time to culture conversion for each treatment arm was not estimable. The time to culture conversion was analyzed using Cox regression model to estimate hazards ratio.||7.63|2.01|<0.0001
91582021|NCT00138671|183054276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||90.0|-0.17|0.36||||||Week 6||0.36|-0.17|
91777181|NCT02761330|183435474|OTHER|||||||0.012||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.012
91777182|NCT02761330|183435474|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
91582022|NCT00138671|183054276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||||90.0|-0.27|0.26||||||Week 12||0.26|-0.27|
91582023|NCT00138671|183054276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||||90.0|-0.29|0.26||||||Week 26||0.26|-0.29|
91582024|NCT00138671|183054276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||||90.0|-0.36|0.2||||||Week 39||0.20|-0.36|
91582025|NCT00138671|183054276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-0.23|0.35||||||Week 52||0.35|-0.23|
91582026|NCT00138671|183054276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||||90.0|-0.29|0.31||||||Week 52 LOCF||0.31|-0.29|
91582027|NCT00138671|183054277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.475||||||90.0|-23.47|14.518||||||Week 6||14.518|-23.47|
91582028|NCT00138671|183054277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91||||||90.0|-30.04|8.232||||||Week 12||8.232|-30.04|
91582029|NCT00138671|183054277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.84||||||90.0|-42.51|-3.166||||||Week 26||-3.166|-42.51|
91582030|NCT00138671|183054277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.222||||||90.0|-28.52|12.075||||||Week 39||12.075|-28.52|
91582031|NCT00138671|183054277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.329||||||90.0|-29.27|12.616||||||Week 52||12.616|-29.27|
91582032|NCT00138671|183054277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.406||||||90.0|-13.7|16.514||||||Week 52 LOCF||16.514|-13.70|
91582033|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||||90.0|-0.317|2.084||||||Week 1||2.084|-0.317|
91582034|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||||90.0|-0.728|1.668||||||Week 2||1.668|-0.728|
91582035|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.382||||||90.0|-0.815|1.579||||||Week 3||1.579|-0.815|
91582036|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.405||||||90.0|-0.793|1.602||||||Week 4||1.602|-0.793|
91582037|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562||||||90.0|-0.642|1.766||||||Week 6||1.766|-0.642|
91582038|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.416||||||90.0|-0.809|1.641||||||Week 9||1.641|-0.809|
91582039|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019||||||90.0|-1.416|1.454||||||Week 11||1.454|-1.416|
91646390|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.1285|TWO_SIDED|95.0|0.81|5.51|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||5.51|0.81|0.1285
91777183|NCT02761330|183435474|OTHER|||||||0.203||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.203
91777184|NCT02761330|183435474|OTHER|||||||0.008||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.008
91777185|NCT02761330|183435474|OTHER|||||||0.496||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.496
91777186|NCT02761330|183435474|OTHER|||||||0.844||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.844
91777187|NCT02761330|183435474|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.016
91777188|NCT02761330|183435474|OTHER|||||||0.062||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.062
91777189|NCT02761330|183435474|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.039
91582040|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||||90.0|-1.127|1.308||||||Week 12||1.308|-1.127|
91582041|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.309||||||90.0|-1.551|0.934||||||Week 18||0.934|-1.551|
91582042|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.869||||||90.0|-2.123|0.384||||||Week 26||0.384|-2.123|
91582043|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.664||||||90.0|-2.968|-0.36||||||Week 39||-0.360|-2.968|
91582044|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.116||||||90.0|-3.829|-0.403||||||Week 50||-0.403|-3.829|
91582045|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.801||||||90.0|-3.204|-0.397||||||Week 51||-0.397|-3.204|
91582046|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.026||||||90.0|-3.384|-0.668||||||Week 52||-0.668|-3.384|
91582047|NCT00138671|183054278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.451||||||90.0|-3.003|0.101||||||Week 52 LOCF||0.101|-3.003|
91582048|NCT00395460|183054305|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).|Mean Difference (Final Values)|6.939|STANDARD_DEVIATION|38.83|||ONE_SIDED|95.0|-3.897||||non-inferiority||||||-3.897|
91582049|NCT02943226|183054317|SUPERIORITY|||||||0.4487|||||||two sample t-test|||||||0.4487
91582050|NCT02943226|183054318|SUPERIORITY|||||||0.0112|||||||Wilcoxon (Mann-Whitney)|||||||0.0112
91582051|NCT02943226|183054319|SUPERIORITY|||||||0.0784|||||||two sample t-test|||||||0.0784
91582052|NCT00298090|183054320|SUPERIORITY_OR_OTHER||Other|0.0||||0.55|TWO_SIDED|95.0|-0.8|1.48|||repeated measures model||A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.|||1.48|-0.80|0.55
91582053|NCT01708213|183054322|SUPERIORITY_OR_OTHER||Parametric Testing|0.05|||<|0.05|TWO_SIDED||||||Parametric testing|||||||<0.05
91582054|NCT03538301|183054417|SUPERIORITY||Slope|-0.004153||||0.049|TWO_SIDED|95.0|-0.008284|-0.000021|||random coefficient model|||Slope in FVC (L/week) in the 45 mg cohort versus placebo||-0.000021|-0.008284|0.049
91582055|NCT03538301|183054417|SUPERIORITY||Slope|-0.002112||||0.316|TWO_SIDED|95.0|-0.00626|0.002036|||random coefficient model|||Slope in FVC (L/week) in the 90 mg cohort versus placebo||0.002036|-0.006260|0.316
91582056|NCT03538301|183054418|SUPERIORITY||Slope|-0.091238||||0.098|TWO_SIDED|95.0|-0.199456|0.016979|||random coefficient model|||||0.016979|-0.199456|0.098
91582057|NCT03538301|183054418|SUPERIORITY||Slope|-0.039596||||0.473|TWO_SIDED|95.0|-0.148248|0.069056|||random coefficient model|||||0.069056|-0.148248|0.473
91582058|NCT03538301|183054419|SUPERIORITY||Mean Difference (Final Values)|-0.0997||||0.049|TWO_SIDED|95.0|-0.1988|-0.0005|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 45 mg cohort versus placebo||-0.0005|-0.1988|0.049
91646391|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.1257|TWO_SIDED|95.0|0.85|3.83|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.83|0.85|0.1257
91777190|NCT02761330|183435475|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
91777191|NCT02761330|183435475|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.039
91582059|NCT03538301|183054419|SUPERIORITY||Mean Difference (Final Values)|-0.0507||||0.316|TWO_SIDED|95.0|-0.1502|0.0489|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 90 mg cohort versus placebo||0.0489|-0.1502|0.316
91582060|NCT03538301|183054420|SUPERIORITY||Median Difference (Final Values)|-3.16||||0.668|TWO_SIDED|95.0|-17.59|11.28|||random coefficient model|||||11.28|-17.59|0.668
91582061|NCT03538301|183054420|SUPERIORITY||Median Difference (Final Values)|-1.72||||0.821|TWO_SIDED|95.0|-16.57|13.13|||random coefficient model|||||13.13|-16.57|0.821
91582062|NCT03538301|183054421|SUPERIORITY||Median Difference (Final Values)|-2.1897||||0.098|TWO_SIDED|95.0|-4.7869|0.4075|||random coefficient model|||Change from baseline to Week 24 in ppFVC||0.4075|-4.7869|0.098
91582063|NCT03538301|183054421|SUPERIORITY||Median Difference (Final Values)|-0.9503||||0.473|TWO_SIDED|95.0|-3.5579|1.6573|||random coefficient model|||Change from Baseline to Week 24 in ppFVC||1.6573|-3.5579|0.473
91582064|NCT03538301|183054422|SUPERIORITY||Median Difference (Final Values)|-2.53||||0.7|TWO_SIDED|95.0|-15.4|10.34|||random coefficient model|||||10.34|-15.40|0.700
91582065|NCT03538301|183054422|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.867|TWO_SIDED|95.0|-14.31|12.07|||random coefficient model|||||12.07|-14.31|0.867
91582066|NCT03538301|183054425|SUPERIORITY||Mean Difference (Final Values)|0.146||||0.708|TWO_SIDED|95.0|-0.6226|0.9147|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.9147|-0.6226|0.708
91582067|NCT03538301|183054425|SUPERIORITY||Mean Difference (Final Values)|0.7038||||0.074|TWO_SIDED|95.0|-0.0695|1.4771|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.4771|-0.0695|0.074
91582068|NCT03538301|183054425|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.765|TWO_SIDED|95.0|-0.6362|0.8641|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.8641|-0.6362|0.765
91582069|NCT03538301|183054425|SUPERIORITY||Mean Difference (Final Values)|0.556||||0.148|TWO_SIDED|95.0|-0.1986|1.3107|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.3107|-0.1986|0.148
91582070|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.765|TWO_SIDED|95.0|-3.68|2.71|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 45 mg cohort versus placebo||2.71|-3.68|0.765
91582071|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.37|TWO_SIDED|95.0|-1.68|4.47|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 90 mg cohort versus placebo||4.47|-1.68|0.370
91582072|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.499|TWO_SIDED|95.0|-0.7|0.34|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 45 mg cohort versus placebo||0.34|-0.70|0.499
91582073|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.901|TWO_SIDED|95.0|-0.47|0.54|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 90 mg cohort versus placebo||0.54|-0.47|0.901
91582074|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.676|TWO_SIDED|95.0|-2.25|3.46|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 45 mg cohort versus placebo||3.46|-2.25|0.676
91582075|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.242|TWO_SIDED|95.0|-1.13|4.42|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 90 mg cohort versus placebo||4.42|-1.13|0.242
91777192|NCT02761330|183435475|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
91582076|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.14|TWO_SIDED|95.0|-2.82|0.4|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 45 mg cohort versus placebo||0.40|-2.82|0.140
91582077|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.211|TWO_SIDED|95.0|-2.53|0.56|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 90 mg cohort versus placebo||0.56|-2.53|0.211
91582078|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.568|TWO_SIDED|95.0|-2.16|3.91|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 45 mg cohort versus placebo||3.91|-2.16|0.568
91582079|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.573|TWO_SIDED|95.0|-3.76|2.09|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 90 mg cohort versus placebo||2.09|-3.76|0.573
91582080|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.012|TWO_SIDED|95.0|-6.35|-0.81|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 45 mg cohort versus placebo||-0.81|-6.35|0.012
91582081|NCT03538301|183054426|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.112|TWO_SIDED|95.0|-4.82|0.51|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 90 mg cohort versus placebo||0.51|-4.82|0.112
91582082|NCT03538301|183054427|SUPERIORITY|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||||||0.256
91582083|NCT03538301|183054427|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||||||0.241
91582084|NCT03538301|183054428|SUPERIORITY||Hazard Ratio (HR)|0.649||||0.517|TWO_SIDED|95.0|0.189|2.225|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 45 mg cohort versus placebo||2.225|0.189|0.517
91582085|NCT03538301|183054428|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.506|TWO_SIDED|95.0|0.198|2.324|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 90 mg cohort versus placebo||2.324|0.198|0.506
91582086|NCT03538301|183054428|SUPERIORITY||Proportion Difference (Final Values)|-9.3||||0.313|TWO_SIDED|95.0|-25.2|5.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of First IPF Exacerbation (%) in the 45 mg cohort versus placebo||5.5|-25.2|0.313
91777193|NCT02761330|183435475|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||1.0
91777194|NCT02761330|183435475|OTHER|||||||0.195||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.195
91777195|NCT02761330|183435475|OTHER|||||||0.57||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.570
91582087|NCT03538301|183054428|SUPERIORITY|The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Proportion Difference (Final Values)|-6.7||||0.376|TWO_SIDED|95.0|-22.6|9.2|||Chi-squared|||Rate of First IPF Exacerbation (%) in the 90 mg cohort versus placebo||9.2|-22.6|0.376
91582088|NCT03538301|183054429|SUPERIORITY||Proportion Difference (Final Values)|-4.6||||0.713|TWO_SIDED|95.0|-19.2|9.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 45 mg cohort versus placebo||9.6|-19.2|0.713
91582089|NCT03538301|183054429|SUPERIORITY||Proportion Difference (Final Values)|-4.4||||0.713|TWO_SIDED|95.0|-19.2|10.7|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 90 mg cohort versus placebo||10.7|-19.2|0.713
91582090|NCT03538301|183054430|SUPERIORITY|||||||0.937|||||||Log Rank|||Overall Survival (weeks) in the 45 mg cohort versus placebo||||0.937
91582091|NCT03538301|183054430|SUPERIORITY|||||||0.414|||||||Log Rank|||Overall Survival (weeks) in the 90 mg cohort versus placebo||||0.414
91582092|NCT03538301|183054430|SUPERIORITY||Proportion Difference (Final Values)|0.1|||>|0.999|TWO_SIDED|95.0|-10.4|10.9|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 45 mg cohort versus placebo||10.9|-10.4|>0.999
91582093|NCT03538301|183054430|SUPERIORITY||Proportion Difference (Final Values)|-2.4|||>|0.999|TWO_SIDED|95.0|-13.1|6.8|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 90 mg cohort versus placebo||6.8|-13.1|>0.999
91582094|NCT03538301|183054431|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.6|4.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 45 mg cohort versus placebo||4.6|-16.6|0.494
91582095|NCT03538301|183054431|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.2|4.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 90 mg cohort versus placebo||4.5|-16.2|0.494
91582096|NCT00515853|183054433|SUPERIORITY|||||||0.54|||||||Regression, Linear|||CCI final||||0.54
91582097|NCT00943111|183054437|NON_INFERIORITY_OR_EQUIVALENCE|The sample size for study was based on expected stability rates of 95% for the Imiglucerase group and 85% for the Eliglustat group, power of 85%, a one-sided significance level of 0.025, a non-inferiority margin of 25%, and a 20% non-evaluable/drop-out rate. Eliglustat was declared non-inferior to Imiglucerase if the lower-bound of the 95% confidence interval for the difference was within the non-inferiority margin of 25%.|Difference in Percentage Stable|-8.8|||||TWO_SIDED|95.0|-17.6|4.2||||||||4.2|-17.6|
91582098|NCT03798691|183054454|SUPERIORITY|||||||0.16|||||||Mann-Whitney U test|||one month after series completion of two dose series||||0.16
91582099|NCT04548544|183054461|OTHER|||||||0.38|||||||ANOVA|||timepoint × group interaction|timepoint × group interaction F = 0.77, p = 0.38|||0.38
91777196|NCT02761330|183435475|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.031
91777197|NCT02761330|183435475|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.016
91582100|NCT00728910|183054462|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that the sequential addition of a fibrate and niacin to baseline atorvastatin therapy would not have any effect on apo-AI catabolism.||||>0.5
91582101|NCT00728910|183054463|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on apo-A1 production rates||||>0.5
91582102|NCT00728910|183054464|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on post-prandial triglyceride levels following an oral fat load||||<0.0005
91582103|NCT00728910|183054464|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0005
91582104|NCT04155203|183054465|EQUIVALENCE|The primary efficacy endpoint was the proportion of subjects in each treatment group with clinical cure, defined as a SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).|equivalence ratio|0.97|||||TWO_SIDED|90.0|-8.19|2.7||||||||2.70|-8.19|
91777198|NCT02761330|183435475|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Abstract Matching (AM) task reaction time.||||1.00
91777199|NCT02761330|183435475|OTHER|||||||0.109||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Abstract Matching (AM) task reaction time.||||0.109
91777200|NCT02761330|183435483|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
91777201|NCT02761330|183435483|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
91777202|NCT02761330|183435483|OTHER|||||||0.557|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.557
91582105|NCT01586910|183054503|NON_INFERIORITY|Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971|Posterior Median of the Difference|-1.4|||||TWO_SIDED|||||The posterior probability of non-inferiority is \> 0.9999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.||||
91582106|NCT02502097|183054530|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.5096|TWO_SIDED|95.0|-10.1|5.1|||Mixed Models Analysis||LS mean difference Day 7|||5.1|-10.1|0.5096
91582107|NCT02502097|183054530|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-0.8||||0.8983|TWO_SIDED|95.0|-13.4|11.8|||Mixed Models Analysis||LS mean difference Day 14|||11.8|-13.4|0.8983
91582108|NCT02502097|183054534|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.7||||0.5005|TWO_SIDED|95.0|-14.6|7.2|||Mixed Models Analysis||LS means difference Day 7|||7.2|-14.6|0.5005
91582109|NCT02502097|183054534|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.8||||0.8382|TWO_SIDED|95.0|-19.8|16.1|||Mixed Models Analysis||LS means difference Day 14|||16.1|-19.8|0.8382
91582110|NCT02502097|183054535|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.3||||0.8008|TWO_SIDED|95.0|-11.9|9.2|||Mixed Models Analysis||LS means difference Day 7|||9.2|-11.9|0.8008
91582111|NCT02502097|183054535|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.2||||0.9805|TWO_SIDED|95.0|-17.6|18.0|||Mixed Models Analysis||LS means difference Day 14|||18.0|-17.6|0.9805
91582112|NCT02502097|183054538|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.4||||0.3279|TWO_SIDED|95.0|-7.1|2.4|||Mixed Models Analysis||LS means difference Day 7|||2.4|-7.1|0.3279
91582113|NCT02502097|183054538|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.5||||0.7772|TWO_SIDED|95.0|-9.2|12.3|||Mixed Models Analysis||LS means difference Day 14|||12.3|-9.2|0.7772
91582114|NCT02502097|183054539|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.2||||0.3493|TWO_SIDED|95.0|-10.1|3.6|||Mixed Models Analysis||LS means difference Day 7|||3.6|-10.1|0.3493
91582115|NCT02502097|183054539|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.0||||0.8952|TWO_SIDED|95.0|-14.3|16.3|||Mixed Models Analysis||LS means difference Day 14|||16.3|-14.3|0.8952
91777203|NCT02761330|183435484|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.910
91582116|NCT02502097|183054540|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.5||||0.6597|TWO_SIDED|95.0|-8.1|5.2|||Mixed Models Analysis||LS means difference Day 7|||5.2|-8.1|0.6597
91582117|NCT02502097|183054540|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.1||||0.788|TWO_SIDED|95.0|-13.1|17.2|||Mixed Models Analysis||LS means difference Day 14|||17.2|-13.1|0.7880
91582118|NCT02502097|183054544|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.1856|TWO_SIDED|95.0|-6.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-6.3|0.1856
91777204|NCT02761330|183435484|OTHER|||||||0.734|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.734
91777205|NCT02761330|183435484|OTHER|||||||0.322|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.322
91777206|NCT02761330|183435485|OTHER|||||||0.164|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.164
91777207|NCT02761330|183435485|OTHER|||||||0.039|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.039
91582119|NCT02502097|183054544|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.7||||0.5658|TWO_SIDED|95.0|-6.6|12.1|||Mixed Models Analysis||LS mean difference Day 14|||12.1|-6.6|0.5658
91646392|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.2944|TWO_SIDED|95.0|0.7|3.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.31|0.70|0.2944
91777208|NCT02761330|183435485|OTHER|||||||0.375|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.375
91777209|NCT02761330|183435486|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
91777210|NCT02761330|183435486|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
91777211|NCT02761330|183435486|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.625
91777212|NCT02761330|183435487|OTHER|||||||0.129|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.129
91777213|NCT02761330|183435487|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.910
91777214|NCT02761330|183435487|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.625
91777215|NCT02761330|183435488|OTHER|||||||1|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||1.000
91777216|NCT02761330|183435488|OTHER|||||||0.496|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.496
91777217|NCT02761330|183435488|OTHER|||||||0.16|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.160
91777218|NCT02761330|183435489|OTHER|||||||0.008|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.008
91777219|NCT02761330|183435489|OTHER|||||||0.359|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.359
91777220|NCT02761330|183435489|OTHER|||||||0.375|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.375
91777221|NCT05386329|183435491|SUPERIORITY|Comparison of mid-treatment to end-of-treatment|Mean Difference (Final Values)|1.0308|STANDARD_ERROR_OF_MEAN|0.5485|=|0.0719|TWO_SIDED|95.0|-0.09883|2.1605||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CSQ-8 score compared to the end-point (week 8) CSQ-8 score.|Null hypothesis: there is no significant difference in CSQ-8 total scores between midpoint (week 4) and end-of-treatment (week 8).||2.1605|-0.09883|=.0719
91582120|NCT02502097|183054545|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-8.0||||0.0847|TWO_SIDED|95.0|-17.2|1.1|||Mixed Models Analysis||LS mean difference Day 7|||1.1|-17.2|0.0847
91582121|NCT02502097|183054545|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-5.8||||0.3083|TWO_SIDED|95.0|-17.0|5.4|||Mixed Models Analysis||LS mean difference Day 14|||5.4|-17.0|0.3083
91777222|NCT05386329|183435492|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline|Mean Difference (Final Values)|0.4296|STANDARD_ERROR_OF_MEAN|0.8857|=|0.6316|TWO_SIDED|95.0|-1.3884|2.2475||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ credibility score compared to the baseline (week 0) CEQ credibility score.|Null hypothesis: there is no significant difference in treatment credibility total scores between baseline (week 0) and midpoint (week 4).||2.2475|-1.3884|=.6316
91777223|NCT05386329|183435493|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline.|Mean Difference (Final Values)|1.1512|STANDARD_ERROR_OF_MEAN|0.9213|=|0.2225|TWO_SIDED|95.0|-0.7422|3.0446||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ expectancy scores compared to the baseline (week 0) CEQ expectancy scores.|Null hypothesis: there is no significant difference in treatment expectancy total scores between baseline (week 0) and midpoint (week 4).||3.0446|-0.7422|=.2225
91777224|NCT05386329|183435495|SUPERIORITY|Comparison of post-treatment (week 8) to mid-treatment (week 4)|Wilcoxon Z|0.2712|||=|0.7873|TWO_SIDED|||||The a priori threshold for statistical significance was alpha=.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no significant difference in treatment utilization between midpoint (week 4) and end of treatment (week 8).||||=.7873
91646393|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.7032|TWO_SIDED|95.0|0.45|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.21|0.45|0.7032
91582122|NCT02502097|183054546|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.0||||0.229|TWO_SIDED|95.0|-5.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-5.3|0.2290
91582123|NCT02502097|183054546|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.0||||0.9794|TWO_SIDED|95.0|-3.5|3.4|||Mixed Models Analysis||LS mean difference Day 14|||3.4|-3.5|0.9794
91646394|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9922|TWO_SIDED|95.0|0.37|2.69|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.69|0.37|0.9922
91646395|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.1227|TWO_SIDED|95.0|0.87|3.16|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.16|0.87|0.1227
91646396|NCT01236053|183184708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3809|TWO_SIDED|95.0|0.69|2.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.61|0.69|0.3809
91646397|NCT01236053|183184709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.1757|TWO_SIDED|95.0|0.8|3.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.34|0.80|0.1757
91777225|NCT05386329|183435496|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-7.8424|STANDARD_ERROR_OF_MEAN|1.2858|<|0.0001|TWO_SIDED|95.0|-10.4944|-5.1903||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) HAM-D score compared to the baseline (week 0) HAM-D score.|Null hypothesis: there is no significant difference in HAM-D total scores between baseline (week 0) and end of treatment (week 8).||-5.1903|-10.4944|<.0001
91777226|NCT05386329|183435497|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-9.9409|STANDARD_ERROR_OF_MEAN|1.7329|<|0.0001|TWO_SIDED|95.0|-13.5043|-6.3776||The p-value was not adjusted for multiple comparisons because this was the pre-specified secondary outcome that addresses complementary aspects of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) WSAS scores compared to the baseline (week 0) WSAS scores.|Null hypothesis: there is no significant difference in WSAS total scores between baseline (week 0) and end of treatment (week 8).||-6.3776|-13.5043|<.0001
91777227|NCT05386329|183435498|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|21.5463|STANDARD_ERROR_OF_MEAN|3.4152|<|0.0001|TWO_SIDED|95.0|14.512|28.5806||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary outcome assessing a complementary aspect of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) Q-LES-Q-SF percent scores compared to the baseline (week 0) Q-LES-Q-SF percent scores.|Null hypothesis: there is no significant difference in Q-LES-Q-SF total scores between baseline (week 0) and end of treatment (week 8).||28.5806|14.5120|<.0001
91777228|NCT04973449|183435528|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.08|1.32||||||The analyses were derived using analysis of covariance (ANCOVA).||1.32|1.08|
91777229|NCT04973449|183435529|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.14||||||The analyses were derived using ANCOVA.||1.14|0.90|
91777230|NCT04973449|183435530|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|1.68|||||TWO_SIDED|95.0|-3.11|6.49||||||The analyses were derived using ANCOVA.||6.49|-3.11|
91777231|NCT04973449|183435531|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|3.47|||||TWO_SIDED|95.0|3.09|3.89||||||The analyses were derived using ANCOVA.||3.89|3.09|
91777232|NCT04973449|183435534|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.21|||||TWO_SIDED|95.0|3.06|3.36||||||The analyses were derived using ANCOVA.||3.36|3.06|
91777233|NCT04973449|183435535|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.45|0.56||||||The analyses were derived using ANCOVA.||0.56|0.45|
91777234|NCT04973449|183435536|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.31|||||TWO_SIDED|95.0|0.27|0.35||||||The analyses were derived using ANCOVA.||0.35|0.27|
91777235|NCT04973449|183435537|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.25|1.58||||||The analyses were derived using ANCOVA.||1.58|1.25|
91777236|NCT04973449|183435538|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.84|||||TWO_SIDED|95.0|1.63|2.08||||||The analyses were derived using ANCOVA.||2.08|1.63|
91777237|NCT04973449|183435539|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||The analyses were derived using ANCOVA.||0.99|0.78|
91777238|NCT04973449|183435540|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97||||||The analyses were derived using ANCOVA.||0.97|0.78|
91777239|NCT04973449|183435541|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08||||||The analyses were derived using ANCOVA.||1.08|0.83|
91777240|NCT04973449|183435542|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|6.56|||||TWO_SIDED|95.0|5.82|7.4||||||The analyses were derived using ANCOVA.||7.40|5.82|
91777241|NCT04973449|183435543|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.22|||||TWO_SIDED|95.0|1.99|2.47||||||The analyses were derived using ANCOVA.||2.47|1.99|
91777242|NCT04973449|183435544|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|4.35|||||TWO_SIDED|95.0|3.86|4.9||||||The analyses were derived using ANCOVA.||4.90|3.86|
91777243|NCT04973449|183435545|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.13|1.39||||||The analyses were derived using ANCOVA.||1.39|1.13|
91777244|NCT04973449|183435546|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|4.42|||||TWO_SIDED|95.0|3.85|5.08||||||The analyses were derived using ANCOVA.||5.08|3.85|
91777245|NCT04973449|183435547|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-1.24|||||TWO_SIDED|95.0|-6.62|3.84||||||The analyses were derived using ANCOVA.||3.84|-6.62|
91777246|NCT04973449|183435548|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.86|||||TWO_SIDED|95.0|10.18|23.32||||||The analyses were derived using ANCOVA.||23.32|10.18|
91777247|NCT04973449|183435549|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.12|||||TWO_SIDED|95.0|-24.22|-12.07||||||The analyses were derived using ANCOVA.||-12.07|-24.22|
91777248|NCT04973449|183435550|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-7.28|7.23||||||The analyses were derived using ANCOVA.||7.23|-7.28|
91777249|NCT04973449|183435551|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|31.36|||||TWO_SIDED|95.0|24.44|37.82||||||The analyses were derived using ANCOVA.||37.82|24.44|
91777250|NCT04973449|183435552|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-3.55|||||TWO_SIDED|95.0|-9.4|1.9||||||The analyses were derived using ANCOVA.||1.90|-9.40|
91777251|NCT04973449|183435553|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|23.01|||||TWO_SIDED|95.0|15.41|30.23||||||The analyses were derived using ANCOVA.||30.23|15.41|
91777252|NCT04973449|183435554|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-34.24|||||TWO_SIDED|95.0|-40.77|-27.45||||||The analyses were derived using ANCOVA.||-27.45|-40.77|
91777253|NCT04973449|183435555|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.96|||||TWO_SIDED|95.0|-1.31|15.1||||||The analyses were derived using ANCOVA.||15.10|-1.31|
91777254|NCT04973449|183435556|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|29.05|||||TWO_SIDED|95.0|21.76|35.81||||||The analyses were derived using ANCOVA.||35.81|21.76|
91777255|NCT04973449|183435558|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.3|1.42||||||The analyses were derived using ANCOVA.||1.42|1.30|
91777256|NCT04973449|183435559|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||The analyses were derived using ANCOVA.||0.81|0.70|
91777257|NCT04973449|183435560|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.87|||||TWO_SIDED|95.0|3.4|4.39||||||The analyses were derived using ANCOVA.||4.39|3.40|
91777258|NCT04973449|183435561|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.67|||||TWO_SIDED|95.0|0.64|0.7||||||The analyses were derived using ANCOVA.||0.70|0.64|
91777259|NCT04973449|183435562|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.58|||||TWO_SIDED|95.0|-0.61|2.09||||||The analyses were derived using ANCOVA.||2.09|-0.61|
91777260|NCT04973449|183435563|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-35.18|||||TWO_SIDED|95.0|-41.46|-28.44||||||The analyses were derived using ANCOVA.||-28.44|-41.46|
91582124|NCT02502097|183054547|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.0009|TWO_SIDED|95.0|-1.5|-0.4|||Mixed Models Analysis||LS mean difference Week 1|||-0.4|-1.5|0.0009
91777261|NCT04973449|183435564|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-24.93|||||TWO_SIDED|95.0|-31.06|-18.56||||||The analyses were derived using ANCOVA.||-18.56|-31.06|
91777262|NCT04973449|183435565|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-1.63|1.56||||||The analyses were derived using ANCOVA.||1.56|-1.63|
91777263|NCT04973449|183435566|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-19.18|||||TWO_SIDED|95.0|-23.8|-14.98||||||The analyses were derived using ANCOVA.||-14.98|-23.80|
91777264|NCT04973449|183435567|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|39.18|||||TWO_SIDED|95.0|32.68|45.21||||||The analyses were derived using ANCOVA.||45.21|32.68|
91777265|NCT04973449|183435568|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-1.62|1.62||||||The analyses were derived using ANCOVA.||1.62|-1.62|
91777266|NCT04973449|183435569|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.52|||||TWO_SIDED|95.0|0.45|0.59||||||The analyses were derived using ANCOVA.||0.59|0.45|
91777267|NCT04973449|183435570|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.68|0.86||||||The analyses were derived using ANCOVA.||0.86|0.68|
91777268|NCT04973449|183435571|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.6|||||TWO_SIDED|95.0|1.43|1.79||||||The analyses were derived using ANCOVA.||1.79|1.43|
91777269|NCT04973449|183435572|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||The analyses were derived using ANCOVA.||0.85|0.67|
91777270|NCT04973449|183435573|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
91777271|NCT04973449|183435574|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.5|||||TWO_SIDED|95.0|7.07|21.71||||||The analyses were derived using ANCOVA.||21.71|7.07|
91777272|NCT04973449|183435575|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
91777273|NCT04973449|183435576|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.87|||||TWO_SIDED|95.0|10.15|23.4||||||The analyses were derived using ANCOVA.||23.40|10.15|
91777274|NCT04973449|183435577|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-7.21|7.21||||||The analyses were derived using ANCOVA.||7.21|-7.21|
91777275|NCT04973449|183435578|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28||||||The analyses were derived using ANCOVA.||2.28|1.75|
91777276|NCT04973449|183435579|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.96|||||TWO_SIDED|95.0|2.64|3.32||||||The analyses were derived using ANCOVA.||3.32|2.64|
91777277|NCT04973449|183435580|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.35|1.69||||||The analyses were derived using ANCOVA.||1.69|1.35|
91777278|NCT04973449|183435581|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.85|||||TWO_SIDED|95.0|0.78|0.94||||||The analyses were derived using ANCOVA.||0.94|0.78|
91777279|NCT04973449|183435582|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-41.2|||||TWO_SIDED|95.0|-47.57|-34.41||||||The analyses were derived using ANCOVA.||-34.41|-47.57|
91777280|NCT04973449|183435583|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.05|||||TWO_SIDED|95.0|-1.81|13.77||||||The analyses were derived using ANCOVA.||13.77|-1.81|
91777281|NCT04973449|183435584|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-26.56|||||TWO_SIDED|95.0|-33.1|-19.94||||||The analyses were derived using ANCOVA.||-19.94|-33.10|
91777282|NCT04973449|183435585|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|30.69|||||TWO_SIDED|95.0|22.94|37.9||||||The analyses were derived using ANCOVA.||37.90|22.94|
91582125|NCT02502097|183054547|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.005|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis||LS mean difference Week 2|||-0.3|-1.7|0.0050
91777283|NCT04973449|183435586|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.64|||||TWO_SIDED|95.0|6.36|22.64||||||The analyses were derived using ANCOVA.||22.64|6.36|
91582126|NCT02502097|183054548|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.8||||0.2938|TWO_SIDED|95.0|-8.2|2.5|||Mixed Models Analysis||LS mean difference Day 7|||2.5|-8.2|0.2938
91582127|NCT02502097|183054548|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-4.0||||0.1319|TWO_SIDED|95.0|-9.2|1.2|||Mixed Models Analysis||LS mean difference Day 14|||1.2|-9.2|0.1319
91582128|NCT02502097|183054549|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.2175|TWO_SIDED|95.0|-1.5|0.4|||Mixed Models Analysis||LS mean difference Day 7|||0.4|-1.5|0.2175
91582129|NCT02502097|183054549|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5312|TWO_SIDED|95.0|-1.4|0.7|||Mixed Models Analysis||LS mean difference Day 14|||0.7|-1.4|0.5312
91777284|NCT04973449|183435587|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||The analyses were derived using analysis of covariance (ANCOVA).||0.96|0.74|
91582130|NCT00252733|183054572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.0508|TWO_SIDED|95.0|0.673|1.001|||Log Rank|Generalized||||1.001|0.673|0.0508
91582131|NCT01878214|183054598|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||||||0.76
91582132|NCT01878214|183054599|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Logistic|||||||0.79
91582133|NCT01878214|183054600|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Logistic|||Smoking frequency||||0.63
91582134|NCT01878214|183054600|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Smoking quantity||||0.30
91582135|NCT01878214|183054601|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Logistic|||||||0.28
91582136|NCT01878214|183054602|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Regression, Logistic|||Motivation to quit||||0.09
91582137|NCT01878214|183054602|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||Thinking about quitting||||0.04
91582138|NCT00495586|183054603|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.5|<|0.05|TWO_SIDED|95.0|3.7|24.3|||Chi-squared|||For the comparison of the efficacy of antibiotic versus placebo, we accepted a null hypothesis if the cure rate in the intervention group was the same or ±7% as that observed in the placebo arm. Based on previous studies, the expected rate of cure among patients assigned to antibiotic therapy was 90%. For an alpha of 0.05 and a beta of 0.2 and accepting possible losses of 15%, we calculated that the sample size is 677 patients in total.||24.3|3.7|<0.05
91613237|NCT03461289|183120853|SUPERIORITY||Difference of Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.48|0.87|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 (26.1%) babies were alive and did not need mechanical ventilation at 14 months of age.|0.87|0.48|<0.0001
91613238|NCT00515463|183120886|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||Risk difference \> 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.|||0.7|-0.7|
91613239|NCT00515463|183120887|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7||||||||0.7|-0.7|
91613240|NCT02273323|183120968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.43|TWO_SIDED|0.23|-0.37|0.83|||Mixed Models Analysis|||Estimated effect of tea vs placebo||0.83|-0.37|0.43
91613241|NCT02273323|183120969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.2|TWO_SIDED|95.0|-0.4|1.82|||Mixed Models Analysis|Subject=random factor; treatment, on/off medication, period = fixed effects||Estimated effect of tea vs. placebo||1.82|-0.40|0.20
91613242|NCT02273323|183120970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.26|2.55|||Mixed Models Analysis|||||2.55|-5.26|
91613243|NCT02273323|183120971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.16|1.37|||Mixed Models Analysis|||||1.37|-2.16|
91613244|NCT02273323|183120972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.65|0.87|||Mixed Models Analysis|||||0.87|-4.65|
91613245|NCT02273323|183120973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||||TWO_SIDED|95.0|-0.73|4.09|||Mixed Models Analysis|||||4.09|-0.73|
91613246|NCT00633139|183120974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|TWO_SIDED||||||ANCOVA|||||||0.4013
91613247|NCT00633139|183120975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|TWO_SIDED|95.0|||||ANCOVA|||||||0.2750
91613248|NCT00633139|183120976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1363|TWO_SIDED|95.0|||||ANCOVA|||||||0.1363
91613249|NCT01507246|183120979|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.62||||0.0251|TWO_SIDED|95.0|1.14|6.03|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.||6.03|1.14|0.0251
91613250|NCT01507246|183120980|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.24||||0.02767|TWO_SIDED|95.0|1.03|1.49|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis = distribution of costs is identical between the two groups.||1.49|1.03|0.02767
91613251|NCT01522651|183120986|OTHER|Pairwise Comparative analysis|Percentage Difference|-19.8|STANDARD_ERROR_OF_MEAN|25.7||0.493|TWO_SIDED|95.0|-57.5|51.5||An equal-slopes analysis of covariance (ANCOVA) model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||51.5|-57.5|0.493
91582139|NCT03038438|183054605|OTHER|Single arm study with a hypothesis test comparing to performance goal|Proportion|88.0|||<|0.0001|ONE_SIDED|97.5|82.5||||Fisher Exact|||"The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:~H0: π ≤ PG vs. HA: π \> PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%."|||82.5|<0.0001
91646398|NCT01236053|183184709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.4405|TWO_SIDED|95.0|0.64|2.75|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.75|0.64|0.4405
91646399|NCT01236053|183184709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.442|TWO_SIDED|95.0|0.71|2.16|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.16|0.71|0.4420
91646400|NCT01236053|183184709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9034|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.82|0.59|0.9034
91646401|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.2395|TWO_SIDED|95.0|0.65|5.6|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.60|0.65|0.2395
91646402|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.3764|TWO_SIDED|95.0|0.55|4.93|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.93|0.55|0.3764
91777285|NCT04973449|183435588|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.62|1.8||||||The analyses were derived using ANCOVA.||1.80|1.62|
91777286|NCT04973449|183435589|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.44|0.56||||||The analyses were derived using ANCOVA.||0.56|0.44|
91777287|NCT04973449|183435590|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.38|||||TWO_SIDED|95.0|0.32|0.44||||||The analyses were derived using ANCOVA.||0.44|0.32|
91777288|NCT03137992|183435739|EQUIVALENCE|Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.|Least Squared Mean Ratio|0.9369|||||TWO_SIDED|90.0|0.834|1.047|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the Lupin Tiotropium and Spiriva Handihaler LS mean ratio.|A blinded interim analysis was performed after 241 subjects had been randomized with measurable AUC data, which estimated 238 patients would be needed to demonstrate BE with 90% power. Therefore, it was planned that approximately 378 patients would be randomized to allow for a potential 30% loss/withdrawal from the PP population.||1.047|0.834|
91777289|NCT03137992|183435740|SUPERIORITY||Least Squared Mean Difference|3.29|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|2.9386|3.646||Efficacy of the Test (T) product was demonstrated if the T was shown to be statistically superior to Placebo (p\<0.05 \[two-tailed\]).Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.646|2.9386|<0.001
91777290|NCT03137992|183435740|SUPERIORITY||Least Squared Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|3.0718|3.7797||Study sensitivity was demonstrated if the Reference (R) product was shown to be statistically superior to Placebo (P) (p \<0.05 \[two-tailed\]). Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.7797|3.0718|<0.001
91777291|NCT05010707|183435783|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||Time x treatment (month 0, and 1 month)||||0.005
91777292|NCT05010707|183435783|SUPERIORITY||Mean Difference (Final Values)|-225.3||||0.02|TWO_SIDED|95.0|-421.71|-28.79|||Mixed Models Analysis|||||-28.79|-421.71|0.02
91777293|NCT05010707|183435783|SUPERIORITY||Mean Difference (Final Values)|-250.6||||0.009|TWO_SIDED|95.0|-447.1|-54.19|||Mixed Models Analysis|||||-54.19|-447.10|0.009
91777294|NCT05010707|183435784|SUPERIORITY|||||||0.951|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.951
91777295|NCT05010707|183435784|SUPERIORITY||Mean Difference (Final Values)|-1.6||||1|TWO_SIDED|95.0|-29.6|26.4|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||26.4|-29.6|1
91777296|NCT05010707|183435784|SUPERIORITY||Mean Difference (Final Values)|-7.1||||1|TWO_SIDED|95.0|-35.1|20.8|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||20.8|-35.1|1
91777297|NCT05010707|183435785|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.004
91777298|NCT05010707|183435785|SUPERIORITY||Mean Difference (Final Values)|-280.4||||0.005|TWO_SIDED|95.0|-487.3|-73.5|||Mixed Models Analysis|||||-73.5|-487.3|0.005
91777299|NCT05010707|183435785|SUPERIORITY||Mean Difference (Final Values)|-204.1||||0.054|TWO_SIDED|95.0|-411.1|2.8|||Mixed Models Analysis|||||2.8|-411.1|0.054
91777300|NCT00906204|183435791|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.||||||0.64|TWO_SIDED||||||Fisher Exact|||The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.||||0.64
91777301|NCT00906204|183435792|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Log Rank|||||||0.35
91777302|NCT00906204|183435793|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Log Rank|||||||0.47
91777303|NCT00906204|183435794|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Log Rank|||||||0.78
91582140|NCT03038438|183054606|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Proportion|2.0|||<|0.0001|ONE_SIDED|97.5||5.0|||Fisher Exact|||"The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:~H0: P ≥ PG vs. HA: P \< PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.~The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%."||5.0||<0.0001
91646403|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.7599|TWO_SIDED|95.0|0.48|2.71|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.71|0.48|0.7599
91646404|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9502|TWO_SIDED|95.0|0.43|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.43|0.9502
91582141|NCT03406260|183054659|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.63|||<|0.0001|TWO_SIDED|95.0|-1000.0|1.81|||Linear Mixed Effects Model|||||1.81|-1000|<0.0001
91646405|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.7164|TWO_SIDED|95.0|0.3|5.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.75|0.30|0.7164
91646406|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9345|TWO_SIDED|95.0|0.24|4.73|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.73|0.24|0.9345
91646407|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8833|TWO_SIDED|95.0|0.28|3.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.02|0.28|0.8833
91777304|NCT00906204|183435795|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Fisher Exact|||||||0.72
91777305|NCT00906204|183435796|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
91777306|NCT00124943|183435827|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.396
91777307|NCT00124943|183435828|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||Fisher Exact|||Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.||||0.783
91777308|NCT00124943|183435829|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Fisher Exact|||Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.||||0.293
91777309|NCT00124943|183435829|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposes||||0.400
91777310|NCT00124943|183435830|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||>0.999
91777311|NCT00124943|183435831|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.061
91777312|NCT00124943|183435832|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Fisher Exact|||Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.709
91777313|NCT00124943|183435832|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Fisher Exact|||Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.495
91777314|NCT00124943|183435833|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||ANOVA|P-value testing dose group differences based on an analysis of variance with dose effect in the model.||||||0.317
91777315|NCT03181932|183435834|SUPERIORITY|The primary efficacy endpoint was tested sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3). If a statistically significant difference was observed in favor of vancomycin inhalation powder compared to placebo after Cycle 1, then the mean change in the FEV1 percent predicted during Cycle 2 was to be tested. Similarly, if the effect after Cycle 2 was statistically significant, then the analysis of Baseline to end of Cycle 3 was to be tested.|Least square mean difference|1.4||||0.325|TWO_SIDED|95.0|-1.4|4.1|||Mixed Models Analysis|||Based on previous experience, a sample size of 45 participants per arm would provide 89% power to detect a statistically significant difference at alpha level of 0.05. To account for potential dropouts and/or smaller effect size in a 3-cycle trial, a sample size of 75 participants per arm was to be enrolled in the primary analysis population, which if all completed would provide 90% power to detect a difference of 3.4% at 20 weeks assuming the same standard deviation of 6.3%.||4.1|-1.4|0.325
91777316|NCT01887327|183435846|OTHER||LS Mean Difference vs Placebo|-31.64|||=|2.1e-06|TWO_SIDED|95.0|-44.0|-19.283|||LS Mean Difference vs Placebo|||||-19.283|-44.000|=0.0000021
91777317|NCT01887327|183435846|OTHER||LS Mean Difference vs Placebo|-27.4|||=|2.6e-05|TWO_SIDED|95.0|-39.657|-15.142|||LS Mean Difference vs Placebo|||||-15.142|-39.657|=0.0000260
91777318|NCT00408317|183435863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.74|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CFA% values including sequence, period, and treatment group as fixed effects; participant identification (ID) as random effect.||||<0.0001
91777319|NCT00408317|183435864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.68|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CNA% values including sequence, period, and treatment group as fixed effects, and participant ID as random effect.||||<0.0001
91777320|NCT02584686|183435887|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the study group using the t-test.||||0.0049
91777321|NCT02584686|183435887|SUPERIORITY_OR_OTHER|||||||0.68|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the control group using the t-test.||||0.68
91777322|NCT02584686|183435889|SUPERIORITY_OR_OTHER|||||||0.01086956|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the study group.||||0.01086956
91777323|NCT02584686|183435889|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the control group.||||0.6618176
91582142|NCT03406260|183054659|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1000.0|2.06|||Linear Mixed Effects Model|||||2.06|-1000|<0.0001
91582143|NCT00871780|183054675|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0003
91582144|NCT00871780|183054675|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0002
91582145|NCT00871780|183054676|SUPERIORITY_OR_OTHER|||||||0.0148|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0148
91582146|NCT00871780|183054676|SUPERIORITY_OR_OTHER|||||||0.0119|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0119
91582147|NCT00871780|183054677|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
91582148|NCT00871780|183054677|SUPERIORITY_OR_OTHER|||||||0.0157|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0157
91582149|NCT00871780|183054678|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
91582150|NCT00871780|183054678|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||<0.0001
91708338|NCT01763827|183309612|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-59.12|-50.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.78|-59.12|<0.001
91582151|NCT00871780|183054679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
91582152|NCT00871780|183054679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
91582153|NCT00871780|183054679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
91582154|NCT00871780|183054680|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
91582155|NCT00871780|183054680|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
91582156|NCT00871780|183054680|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
91582157|NCT00871780|183054681|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
91708339|NCT01763827|183309612|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.73|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-38.73|-30.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.73|-38.73|<0.001
91582158|NCT00871780|183054681|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
91582159|NCT00871780|183054681|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
91582160|NCT00871780|183054682|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
91582161|NCT00871780|183054682|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
91582162|NCT00871780|183054682|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
91582163|NCT00871780|183054683|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
91582164|NCT00871780|183054683|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
91582165|NCT00871780|183054683|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
91582166|NCT00871780|183054684|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
91582167|NCT00871780|183054684|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
91582168|NCT00871780|183054684|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
91582169|NCT00871780|183054685|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
91582170|NCT00871780|183054685|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||0.0016
91582171|NCT00871780|183054685|SUPERIORITY_OR_OTHER|||||||0.0866|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||0.0866
91582172|NCT00871780|183054686|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
91582173|NCT00871780|183054686|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
91582174|NCT00871780|183054686|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
91582175|NCT02527343|183054688|SUPERIORITY||Difference in Least Square Mean|-66.83||||0.0009|TWO_SIDED|95.0|-104.17|-29.48|||ANCOVA|||||-29.48|-104.17|0.0009
91582176|NCT02527343|183054689|SUPERIORITY||Difference in Least Square Mean|-25.69||||0.0736|TWO_SIDED|95.0|-54.03|2.65|||ANCOVA|||Month 6||2.65|-54.03|0.0736
91582177|NCT02527343|183054689|SUPERIORITY||Difference in Least Square Mean|-53.33||||0.0039|TWO_SIDED|95.0|-87.71|-18.95|||ANCOVA|||Month 12||-18.95|-87.71|0.0039
91582178|NCT02527343|183054691|SUPERIORITY||Difference in Least Square Mean|0.3||||0.4108|TWO_SIDED|95.0|-0.43|1.03|||ANCOVA|||Month 3||1.03|-0.43|0.4108
91582179|NCT02527343|183054691|SUPERIORITY||Difference in Least Square Mean|0.19||||0.7308|TWO_SIDED|95.0|-0.95|1.34|||ANCOVA|||Month 6||1.34|-0.95|0.7308
91582180|NCT02527343|183054691|SUPERIORITY||Difference in Least Square Mean|-0.2||||0.7511|TWO_SIDED|95.0|-1.45|1.06|||ANCOVA|||Month 9||1.06|-1.45|0.7511
91582181|NCT02527343|183054691|SUPERIORITY||Difference in Least Square Mean|-0.19||||0.7659|TWO_SIDED|95.0|-1.52|1.13|||ANCOVA|||Month 12||1.13|-1.52|0.7659
91708340|NCT01763827|183309612|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.62|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-40.81|-32.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.42|-40.81|<0.001
91582182|NCT02065687|183054803|EQUIVALENCE|The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).|Cox Proportional Hazard|-0.01787|STANDARD_ERROR_OF_MEAN|0.27472||0.9482|TWO_SIDED||||||Regression, Cox|||The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.||||0.9482
91582183|NCT04426851|183054811|OTHER||Ratio of the geometric means (%)|45.9|||||TWO_SIDED|90.0|41.4|50.9|||||"Ratio was calculated as: BI 1358894 100 mg tablet fasted/BI 1358894 (C-14) 100 ug i.v.~Intra-individual geometric coefficient of variation (gCV)=14.3."|The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed.||50.9|41.4|
91582184|NCT04426851|183054812|OTHER||Ratio of the geometric means (%)|141.4|||||TWO_SIDED|90.0|129.3|154.6|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra -individual geometric coefficient of variation (gCV)=10.9.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||154.6|129.3|
91582185|NCT04426851|183054814|OTHER||Ratio of the geometric means (%)|65.3|||||TWO_SIDED|90.0|54.6|78.0|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV)=22.5.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||78.0|54.6|
91582186|NCT04426851|183054815|OTHER||Ratio of the geometric means (%)|148.4|||||TWO_SIDED|90.0|138.1|159.5|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV) =8.7.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||159.5|138.1|
91582187|NCT04494256|183054835|SUPERIORITY||Least square (LS) mean difference|-0.1|STANDARD_ERROR_OF_MEAN|7.84|=|0.9924|TWO_SIDED|95.0|-15.47|15.32||ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.|ANCOVA|||||15.32|-15.47|=0.9924
91582188|NCT04494256|183054836|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|2.01|=|0.9203|TWO_SIDED|95.0|-4.14|3.74||ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.|ANCOVA|||||3.74|-4.14|=0.9203
91582189|NCT04494256|183054837|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12|=|0.1069|TWO_SIDED|95.0|-0.41|0.04||ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.|ANCOVA|||||0.04|-0.41|=0.1069
91582190|NCT04494256|183054838|SUPERIORITY||Hazard Ratio (HR)|4.29|||=|0.1003|TWO_SIDED|95.0|0.433|42.587|||Log Rank|Log rank test stratified by median baseline plasma NfL||||42.587|0.433|=0.1003
91582191|NCT04494256|183054839|SUPERIORITY||||||=|0.1143|||||||Kaplan-Meier product limit method|||||||=0.1143
91582192|NCT02483585|183054844|SUPERIORITY|A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.61|-0.47|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.47|-1.61|< 0.001
91582193|NCT02483585|183054845|SUPERIORITY||Odds Ratio (OR)|1.59||||0.01|TWO_SIDED|95.0|1.12|2.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.27|1.12|0.010
91582194|NCT02483585|183054846|SUPERIORITY||LS Mean Difference|-0.59||||0.002|TWO_SIDED|95.0|-0.96|-0.21|||Generalized Linear Mixed Model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.21|-0.96|0.002
91582195|NCT02483585|183054847|SUPERIORITY||Odds Ratio (OR)|1.22||||0.26|TWO_SIDED|95.0|0.87|1.71|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.71|0.87|0.26
91582196|NCT02483585|183054848|SUPERIORITY||Odds Ratio (OR)|1.33||||0.13|TWO_SIDED|95.0|0.92|1.9|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.90|0.92|0.13
91582197|NCT00825916|183054859|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.078
91777324|NCT02584686|183435891|SUPERIORITY_OR_OTHER|||||||0.00751288|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the study group before \& after treatment.||||0.00751288
91777325|NCT02584686|183435891|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the control group before \& after treatment.||||0.6618176
91777326|NCT02584686|183435892|SUPERIORITY_OR_OTHER|||||||0.027191||||||"Due to the small sample size Fisher exact test was chosen. 7 out of 12 in the treatment group answered yes, while 1 out of 12 in the control group answered yes."|Fisher Exact|||||||0.027191
91582198|NCT00825916|183054859|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.086
91582199|NCT00825916|183054859|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
91582200|NCT00825916|183054859|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.49
91582201|NCT00825916|183054860|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.74
91582202|NCT00825916|183054860|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
91582203|NCT00825916|183054860|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
91582204|NCT00825916|183054860|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||1.00
91582205|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.34
91582206|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.98
91582207|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.15
91582208|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.83
91582209|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.95
91582210|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
91777327|NCT02584686|183435894|SUPERIORITY_OR_OTHER|||||||0.109091|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in the number of in patients who answered Yes in Secondary Outcome 8 (SEP-Q2 Question Before Treatment) to patients who answered Yes in Secondary Outcome 9 (SEP-Q2 Question after Treatment), for both (BTXA) and Saline groups."||||0.109091
91582211|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.76
91582212|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.63
91582213|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
91582214|NCT00825916|183054861|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
91582215|NCT00825916|183054862|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.95
91582216|NCT00825916|183054862|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.76
91582217|NCT00825916|183054862|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.60
91582218|NCT00825916|183054862|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.44
91582219|NCT00825916|183054862|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.85
91582220|NCT00825916|183054862|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.83
91582221|NCT01778023|183054863|SUPERIORITY_OR_OTHER||Treatment Difference|5.15|||<|0.0001|TWO_SIDED|95.0|4.09|6.21|||ANOVA|The HV after 6 months of treatment was analysed using an ANCOVA method with group and sex as fixed effects, and age as a covariate.||Let D be a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.||6.21|4.09|<0.0001
91582222|NCT01090427|183054916|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582223|NCT01090427|183054916|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582224|NCT01090427|183054917|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582225|NCT01090427|183054917|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582226|NCT01090427|183054918|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||0.003
91582227|NCT01090427|183054918|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||<0.001
91582228|NCT01090427|183054919|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582229|NCT01090427|183054919|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582230|NCT01090427|183054920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
91582231|NCT01090427|183054920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
91582232|NCT01090427|183054920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
91582233|NCT01090427|183054920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
91582234|NCT01090427|183054921|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
91582235|NCT01090427|183054921|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
91582236|NCT01090427|183054921|SUPERIORITY_OR_OTHER|||||||0.014|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||0.014
91582237|NCT01090427|183054921|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||<0.001
91582238|NCT01090427|183054922|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.003
91582239|NCT01090427|183054922|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.028
91582240|NCT01090427|183054922|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.005
91582241|NCT01090427|183054922|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.063
91582242|NCT01090427|183054922|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.007
91582243|NCT01090427|183054922|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.020
91582244|NCT01090427|183054923|SUPERIORITY_OR_OTHER|||||||0.027|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||0.027
91582245|NCT01090427|183054923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
91582246|NCT02891837|183055038|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.4930
91582247|NCT02891837|183055040|OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
91777328|NCT02584686|183435896|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in patients who answered Yes in Secondary Outcome 10 (SEP-Q3 Question Before Treatment) to patients who answered Yes in Secondary Outcome 11 (SEP-Q3 Question after Treatment)."||||1
91582248|NCT02891837|183055041|OTHER|||||||0.8678|||||||Wilcoxon (Mann-Whitney)|||||||0.8678
91582249|NCT02891837|183055048|OTHER|||||||0.6422|||||||Wilcoxon (Mann-Whitney)|||||||0.6422
91582250|NCT02891837|183055049|OTHER|||||||0.7572|||||||Wilcoxon (Mann-Whitney)|||||||0.7572
91582251|NCT02891837|183055051|OTHER|||||||0.3681|||||||Wilcoxon (Mann-Whitney)|||||||0.3681
91582252|NCT02891837|183055055|OTHER|"Sample size calculated with nQuery 7.0. Assumed standard deviation = 50 h, \& mean values of 44 h (placebo) \& 14 h (L-citrulline group), estimated effect size = 0.600, yielding a sample size N=92/group (two-sided Wilcoxon-rank-sum test with 0.01 significance level and 90% power). Assumptions for standard deviation \& mean based on Study CIT-002-01 results.~To allow for subjects being enrolled but not assigned to the full analysis set (FAS), an overall N=95 subjects per group were to be enrolled."|Location shift|219.0||||0.156|TWO_SIDED|95.0|-88.0|626.0||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)||Treatment difference = L-citrulline - placebo For the mean and median values, that the estimated values are given in minutes \[min\]|H0: Composite endpoint in L-citrulline group = placebo group H1: Composite endpoint in L-citrulline group ≠ placebo group H0 tested using Wilcoxon-rank-sum test. Significance level = 1% (2-sided).||626.0|-88.0|0.1560
91582253|NCT02891837|183055055|OTHER||Location shift|813.1||||0.1627|TWO_SIDED|95.0|-335.5|1961.6||The threshold for statistical significance was 0.05.|t-test, 2 sided|The results of the T-test should be interpreted with caution since the endpoint is not normally distributed.|Treatment difference = L-citrulline - placebo. For the mean and median values, the estimated values are given in minutes|Post hoc analyses were done for US patients on mechanical ventilation for \<=48 hours. For all post hoc analyses a significance level of 5% was applied.||1961.6|-335.5|0.1627
91582254|NCT02891837|183055063|OTHER|||||||0.0326||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for all US patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0326
91582255|NCT02891837|183055063|OTHER|||||||0.0026||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for ALL patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0026
91582256|NCT05326815|183055184|OTHER|Spearman Correlation.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91582257|NCT05172050|183055196|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|9.99||||0.0109|TWO_SIDED|95.0|1.781||Upper limit is not estimable (NE) due to the low number of events||Regression, Logistic||||||1.781|0.0109
91777329|NCT02703597|183435919|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8|TWO_SIDED|95.0|0.32|4.2|||Mixed Models Analysis|||"Hypothesis: Participants in the GSA-ASPIRE-Network Group will be more likely to decrease in susceptibility to vaping than participants in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||4.20|0.32|0.80
91777330|NCT02703597|183435919|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.01|TWO_SIDED|95.0|0.06|0.43|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility to vaping over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.43|0.06|<0.01
91777331|NCT02703597|183435920|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7|TWO_SIDED|95.0|0.16|3.49|||Mixed Models Analysis|||"Hypothesis: Adolescents who participated in the GSA-ASPIRE-Network group will be more likely to decrease in susceptibility to using conventional tobacco than adolescents who participated in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||3.49|0.16|0.70
91582258|NCT05172050|183055196|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|5.414||||0.0673|TWO_SIDED|95.0|0.858||The upper limit is not estimable (NE), due to the low number of events||Regression, Logistic||||||0.858|0.0673
91582259|NCT05172050|183055196|SUPERIORITY||Odds Ratio (OR)|12.186||||0.0061|TWO_SIDED|95.0|2.147||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm.|||2.147|0.0061
91582260|NCT05172050|183055196|SUPERIORITY||Odds Ratio (OR)|5.936||||0.0567|TWO_SIDED|95.0|0.938||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm|||0.938|0.0567
91582261|NCT05172050|183055197|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|1.663||||0.7121|TWO_SIDED|95.0|0.337|9.053|||Regression, Logistic|||||9.053|0.337|0.7121
91582262|NCT05172050|183055197|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|0.963|||>|0.999|TWO_SIDED|95.0|0.185|4.977|||Regression, Logistic|||||4.977|0.185|>0.999
91582263|NCT05172050|183055197|SUPERIORITY||Odds Ratio (OR)|2.34||||0.5378|TWO_SIDED|95.0|0.35|20.153||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||20.153|0.350|0.5378
91582264|NCT05172050|183055197|SUPERIORITY||Odds Ratio (OR)|1.209|||>|0.999|TWO_SIDED|95.0|0.185|8.589||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||8.589|0.185|>0.999
91582265|NCT05172050|183055198|SUPERIORITY||Odds Ratio (OR)|1.114|||>|0.999|TWO_SIDED|95.0|0.219|5.708|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 14||5.708|0.219|>0.999
91582266|NCT05172050|183055198|SUPERIORITY||Odds Ratio (OR)|3.202||||0.2553|TWO_SIDED|95.0|0.541|22.116|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||At day 14||22.116|0.541|0.2553
91582267|NCT05172050|183055198|SUPERIORITY||Odds Ratio (OR)|2.16||||0.6189|TWO_SIDED|95.0|0.294|18.532|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||18.532|0.294|0.6189
91582268|NCT05172050|183055198|SUPERIORITY||Odds Ratio (OR)|7.22||||0.1662|TWO_SIDED|95.0|0.586|413.499|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||413.499|0.586|0.1662
91582269|NCT05172050|183055199|SUPERIORITY||Odds Ratio (OR)|0.972|||>|0.999|TWO_SIDED|95.0|0.193|4.906|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||4.906|0.193|>0.999
91582270|NCT05172050|183055199|SUPERIORITY||Odds Ratio (OR)|1.156|||>|0.999|TWO_SIDED|95.0|0.2|6.822|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||6.822|0.200|>0.999
91582271|NCT05172050|183055199|SUPERIORITY||Odds Ratio (OR)|1.066|||>|0.999|TWO_SIDED|95.0|0.208|5.478|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||5.478|0.208|>0.999
91777332|NCT02703597|183435920|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.01|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility of using conventional tobacco over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.40|0.04|<0.01
91777333|NCT03416985|183435935|OTHER|||||||0.1561||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to plaque level after 30 days||||0.1561
91582272|NCT05172050|183055199|SUPERIORITY||Odds Ratio (OR)|2.068||||0.5465|TWO_SIDED|95.0|0.369|12.58|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||12.580|0.369|0.5465
91582273|NCT05172050|183055202|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R60 vs Placebo||||0.3899
91777334|NCT03416985|183435936|OTHER|||||||0.2161||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to Gingival scores at 30 days||||0.2161
91582274|NCT05172050|183055202|SUPERIORITY|||||||0.4075||||||P-Value comparing % among treatment groups Raloxifene 120 mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R120 vs placebo||||0.4075
91582275|NCT05172050|183055202|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R60 vs placebo||||0.3899
91582276|NCT05172050|183055202|SUPERIORITY|||||||0.4075|||||||Fisher Exact|P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R120 vs placebo||||0.4075
91582277|NCT05172050|183055202|SUPERIORITY|||||||0.6846||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R60 vs placebo||||0.6846
91582278|NCT05172050|183055202|SUPERIORITY|||||||0.6614||||||P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R120 vs placebo||||0.6614
91582279|NCT05172050|183055204|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||Log Rank|||||1.00|1.00|
91582280|NCT05172050|183055204|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0||p value= not estimable|Log Rank|||||1.00|1.00|
91582281|NCT02909764|183055207|OTHER|||||||0.3|||||||ANOVA|||||||0.30
91582282|NCT02909764|183055208|OTHER|Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|||||<|0.05|||||||Chi-squared|||Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.||||<0.05
91582283|NCT02909764|183055209|OTHER|||||||0.32|||||||ANOVA|||||||0.32
91582284|NCT02909764|183055210|OTHER|||||||0.77|||||||ANOVA|||||||0.77
91582285|NCT02909764|183055211|OTHER|General estimating equations (GEE)|||||<|0.05|||||||GEE|||Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.||||<0.05
91582286|NCT02909764|183055212|OTHER|T-tests were conducted to determine whether differences in baseline blood pressure between groups|||||>|0.4|||||||t-test, 2 sided|||T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.||||>0.40
91582287|NCT04617275|183055222|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.5863|TWO_SIDED|90.0|-15.23|19.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||19.85|-15.23|0.5863
91582288|NCT04617275|183055222|SUPERIORITY||Mean Difference (Final Values)|-17.41||||0.0494|TWO_SIDED|90.0|-34.75|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-34.75|0.0494
91777335|NCT02006472|183435937|SUPERIORITY||LSM difference|1.42||||0.3202|TWO_SIDED|95.0|-1.39|4.23|||Mixed Models Analysis|||||4.23|-1.39|0.3202
91582289|NCT04617275|183055222|SUPERIORITY||Mean Difference (Final Values)|-30.85||||0.0019|TWO_SIDED|90.0|-48.09|-13.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-13.61|-48.09|0.0019
91582290|NCT04617275|183055222|SUPERIORITY||Mean Difference (Final Values)|-33.66||||0.0009|TWO_SIDED|90.0|-51.0|-16.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-16.32|-51.00|0.0009
91582291|NCT04617275|183055222|SUPERIORITY||Mean Difference (Final Values)|-19.52||||0.0343|TWO_SIDED|90.0|-37.12|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-37.12|0.0343
91582292|NCT04617275|183055223|SUPERIORITY||Mean Difference (Final Values)|-3.33||||0.3804|TWO_SIDED|90.0|-21.41|14.76||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||14.76|-21.41|0.3804
91582293|NCT04617275|183055223|SUPERIORITY||Mean Difference (Final Values)|-19.65||||0.0348|TWO_SIDED|90.0|-37.44|-1.87||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.87|-37.44|0.0348
91777336|NCT02006472|183435937|SUPERIORITY||LSM difference|1.7||||0.2266|TWO_SIDED|95.0|-1.06|4.46|||Mixed Models Analysis|||||4.46|-1.06|0.2266
91777337|NCT02006472|183435937|SUPERIORITY||LSM difference|0.66||||0.6348|TWO_SIDED|95.0|-2.07|3.39|||Mixed Models Analysis|||||3.39|-2.07|0.6348
91777338|NCT02006472|183435937|SUPERIORITY||LSM difference|2.04||||0.1447|TWO_SIDED|95.0|-0.71|4.8|||Mixed Models Analysis|||||4.8|-0.71|0.1447
91777339|NCT02006472|183435939|SUPERIORITY||LSM difference|0.87||||0.0032|TWO_SIDED|95.0|0.29|1.45|||Mixed Models Analysis|||||1.45|0.29|0.0032
91777340|NCT02006472|183435939|SUPERIORITY||LSM difference|0.11||||0.7042|TWO_SIDED|95.0|-0.46|0.68|||Mixed Models Analysis|||||0.68|-0.46|0.7042
91777341|NCT02006472|183435939|SUPERIORITY||LSM difference|0.19||||0.5099|TWO_SIDED|95.0|-0.37|0.75|||Mixed Models Analysis|||||0.75|-0.37|0.5099
91582294|NCT04617275|183055223|SUPERIORITY||Mean Difference (Final Values)|-32.8||||0.0014|TWO_SIDED|90.0|-50.54|-15.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-15.05|-50.54|0.0014
91582295|NCT04617275|183055223|SUPERIORITY||Mean Difference (Final Values)|-35.85||||0.0007|TWO_SIDED|90.0|-53.9|-17.81||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-17.81|-53.90|0.0007
91582296|NCT04617275|183055223|SUPERIORITY||Mean Difference (Final Values)|-28.49||||0.0052|TWO_SIDED|90.0|-46.6|-10.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-10.37|-46.60|0.0052
91582297|NCT04617275|183055224|SUPERIORITY||Mean Difference (Final Values)|-25.58||||0.025|TWO_SIDED|90.0|-46.97|-4.18||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.18|-46.97|0.0250
91582298|NCT04617275|183055224|SUPERIORITY||Mean Difference (Final Values)|-32.95||||0.0053|TWO_SIDED|90.0|-53.95|-11.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-11.95|-53.95|0.0053
91582299|NCT04617275|183055224|SUPERIORITY||Mean Difference (Final Values)|-40.07||||0.0012|TWO_SIDED|90.0|-61.41|-18.73|||Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-18.73|-61.41|0.0012
91646408|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6178|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.22|0.6178
91646409|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.4556|TWO_SIDED|95.0|0.46|5.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||5.53|0.46|0.4556
91646410|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.7478|TWO_SIDED|95.0|0.35|4.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.29|0.35|0.7478
91646411|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.235|TWO_SIDED|95.0|0.71|4.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.13|0.71|0.2350
91646412|NCT01236053|183184710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5428|TWO_SIDED|95.0|0.54|3.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.24|0.54|0.5428
91646413|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.3123|TWO_SIDED|95.0|0.55|6.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.59|0.55|0.3123
91646414|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.3951|TWO_SIDED|95.0|0.49|6.15|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||6.15|0.49|0.3951
91646415|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.4388|TWO_SIDED|95.0|0.56|3.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.75|0.56|0.4388
91646416|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5535|TWO_SIDED|95.0|0.51|3.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.47|0.51|0.5535
91777342|NCT02006472|183435939|SUPERIORITY||LSM difference|0.24||||0.4061|TWO_SIDED|95.0|-0.33|0.82|||Mixed Models Analysis|||||0.82|-0.33|0.4061
91777343|NCT02006472|183435940|SUPERIORITY||LSM difference|1.16||||0.0003|TWO_SIDED|95.0|0.54|1.78|||Mixed Models Analysis|||||1.78|0.54|0.0003
91777344|NCT02006472|183435941|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
91777345|NCT02006472|183435942|SUPERIORITY||LSM difference|-0.0341||||0.0346|TWO_SIDED|95.0|-0.0658|-0.0026|||Mixed Models Analysis|||At Week 26||-0.0026|-0.0658|0.0346
91777346|NCT02006472|183435942|SUPERIORITY||LSM difference|-0.0444||||0.0305|TWO_SIDED|95.0|-0.0847|-0.0042|||Mixed Models Analysis|||At Week 52||-0.0042|-0.0847|0.0305
91777347|NCT05179785|183435948|OTHER|||||||0.2938909|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.29389090
91777348|NCT05179785|183435948|OTHER|||||||0.97863544|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.97863544
91777349|NCT05179785|183435948|OTHER|||||||0.60236264|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.60236264
91777350|NCT05179785|183435948|OTHER|||||||0.35845126|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35845126
91777351|NCT05179785|183435948|OTHER|||||||0.91766025|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.91766025
91777352|NCT05179785|183435948|OTHER|||||||0.09605169|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delayed discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task"||||0.09605169
91777353|NCT05179785|183435949|OTHER|||||||0.50030946|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.50030946
91777354|NCT05179785|183435949|OTHER|||||||0.3751738|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.37517380
91646417|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.6332|TWO_SIDED|95.0|0.4|4.48|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.48|0.40|0.6332
91646418|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8743|TWO_SIDED|95.0|0.32|3.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.75|0.32|0.8743
91646419|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6132|TWO_SIDED|95.0|0.27|2.15|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.15|0.27|0.6132
91646420|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.63||||0.3821|TWO_SIDED|95.0|0.22|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.78|0.22|0.3821
91582300|NCT04617275|183055224|SUPERIORITY||Mean Difference (Final Values)|-45.47||||0.0003|TWO_SIDED|90.0|-66.85|-24.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-24.10|-66.85|0.0003
91646421|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.3591|TWO_SIDED|95.0|0.51|6.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||6.28|0.51|0.3591
91646422|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6899|TWO_SIDED|95.0|0.37|4.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.58|0.37|0.6899
91777355|NCT05179785|183435949|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
91777356|NCT05179785|183435949|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
91777357|NCT05179785|183435949|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
91777358|NCT05179785|183435949|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
91777359|NCT05179785|183435950|OTHER|||||||0.75298499|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75298499
91777360|NCT05179785|183435950|OTHER|||||||0.16043787|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.16043787
91777361|NCT05179785|183435950|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
91777362|NCT05179785|183435950|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
91777363|NCT05179785|183435950|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
91777364|NCT05179785|183435950|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
91777365|NCT05179785|183435951|OTHER|||||||0.73357221|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.73357221
91777366|NCT05179785|183435951|OTHER|||||||0.43954526|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.43954526
91777367|NCT05179785|183435951|OTHER|||||||0.4419898|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.44198980
91777368|NCT05179785|183435951|OTHER|||||||0.39565784|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.39565784
91777369|NCT05179785|183435951|OTHER|||||||0.35602382|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35602382
91777370|NCT05179785|183435951|OTHER|||||||0.30499144|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.30499144
91777371|NCT05179785|183435952|OTHER|||||||0.81601415|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.81601415
91777372|NCT05179785|183435952|OTHER|||||||0.20563452|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20563452
91777373|NCT05179785|183435952|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
91777374|NCT05179785|183435952|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
91777375|NCT05179785|183435952|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
91777376|NCT05179785|183435952|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
91777377|NCT05179785|183435953|OTHER|||||||0.83462055|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.83462055
91582301|NCT04617275|183055224|SUPERIORITY||Mean Difference (Final Values)|-33.63||||0.0055|TWO_SIDED|90.0|-55.19|-12.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-12.08|-55.19|0.0055
91582302|NCT04617275|183055225|SUPERIORITY||Mean Difference (Final Values)|-27.79||||0.0127|TWO_SIDED|90.0|-48.12|-7.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-7.47|-48.12|0.0127
91582303|NCT04617275|183055225|SUPERIORITY||Mean Difference (Final Values)|-25.67||||0.0171|TWO_SIDED|90.0|-45.51|-5.83||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-5.83|-45.51|0.0171
91582304|NCT04617275|183055225|SUPERIORITY||Mean Difference (Final Values)|-46.94||||0.0001|TWO_SIDED|90.0|-67.16|-26.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-26.72|-67.16|0.0001
91582305|NCT04617275|183055225|SUPERIORITY||Mean Difference (Final Values)|-33.79||||0.0037|TWO_SIDED|90.0|-54.32|-13.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-13.27|-54.32|0.0037
91582306|NCT04617275|183055225|SUPERIORITY||Mean Difference (Final Values)|-42.13||||0.0005|TWO_SIDED|90.0|-62.85|-21.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-21.40|-62.85|0.0005
91582307|NCT04617275|183055226|SUPERIORITY||Mean Difference (Final Values)|-12.85||||0.1678|TWO_SIDED|90.0|-34.9|9.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||9.21|-34.90|0.1678
91582308|NCT04617275|183055226|SUPERIORITY||Mean Difference (Final Values)|-14.82||||0.1223|TWO_SIDED|90.0|-35.85|6.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||6.21|-35.85|0.1223
91582309|NCT04617275|183055226|SUPERIORITY||Mean Difference (Final Values)|-33.97||||0.0054|TWO_SIDED|90.0|-55.66|-12.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-12.28|-55.66|0.0054
91582310|NCT04617275|183055226|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.5398|TWO_SIDED|90.0|-20.38|22.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||22.99|-20.38|0.5398
91582311|NCT04617275|183055226|SUPERIORITY||Mean Difference (Final Values)|-14.42||||0.1409|TWO_SIDED|90.0|-36.56|7.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||7.72|-36.56|0.1409
91582312|NCT04617275|183055227|SUPERIORITY||Mean Difference (Final Values)|-28.65||||0.0236|TWO_SIDED|90.0|-52.31|-4.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.99|-52.31|0.0236
91582313|NCT04617275|183055227|SUPERIORITY||Mean Difference (Final Values)|-27.32||||0.0226|TWO_SIDED|90.0|-49.67|-4.97||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.97|-49.67|0.0226
91582314|NCT04617275|183055227|SUPERIORITY||Mean Difference (Final Values)|-40.85||||0.0022|TWO_SIDED|90.0|-64.11|-17.59||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-17.59|-64.11|0.0022
91777378|NCT05179785|183435953|OTHER|||||||0.21582586|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.21582586
91582315|NCT04617275|183055227|SUPERIORITY||Mean Difference (Final Values)|-10.25||||0.2335|TWO_SIDED|90.0|-33.59|13.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||13.08|-33.59|0.2335
91777379|NCT05179785|183435953|OTHER|||||||0.59574875|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.59574875
91582316|NCT04617275|183055227|SUPERIORITY||Mean Difference (Final Values)|-24.38||||0.0494|TWO_SIDED|90.0|-48.69|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-48.69|0.0494
91582317|NCT04617275|183055228|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.2485|TWO_SIDED|90.0|-0.31|0.13||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.13|-0.31|0.2485
91582318|NCT04617275|183055228|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0252|TWO_SIDED|90.0|-0.48|-0.04||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.04|-0.48|0.0252
91582319|NCT04617275|183055228|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0053|TWO_SIDED|90.0|-0.56|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-0.56|0.0053
91582320|NCT04617275|183055228|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.009|TWO_SIDED|90.0|-0.54|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-0.54|0.0090
91582321|NCT04617275|183055228|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1066|TWO_SIDED|90.0|-0.39|0.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.05|-0.39|0.1066
91582322|NCT04617275|183055229|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.274|TWO_SIDED|90.0|-0.4|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-0.40|0.2740
91582323|NCT04617275|183055229|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0196|TWO_SIDED|90.0|-0.66|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-0.66|0.0196
91582324|NCT04617275|183055229|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0006|TWO_SIDED|90.0|-0.88|-0.3|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.30|-0.88|0.0006
91582325|NCT04617275|183055229|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0019|TWO_SIDED|90.0|-0.82|-0.23||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.23|-0.82|0.0019
91582326|NCT04617275|183055229|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0243|TWO_SIDED|90.0|-0.66|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-0.66|0.0243
91582327|NCT04617275|183055230|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1587|TWO_SIDED|90.0|-0.62|0.15||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.15|-0.62|0.1587
91582328|NCT04617275|183055230|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.0027|TWO_SIDED|90.0|-1.04|-0.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.27|-1.04|0.0027
91582329|NCT04617275|183055230|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.0002|TWO_SIDED|90.0|-1.24|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.24|0.0002
91582330|NCT04617275|183055230|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0016|TWO_SIDED|90.0|-1.1|-0.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.32|-1.10|0.0016
91582331|NCT04617275|183055230|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0027|TWO_SIDED|90.0|-1.07|-0.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.28|-1.07|0.0027
91582332|NCT04617275|183055231|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.0472|TWO_SIDED|90.0|-0.86|-0.01||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.01|-0.86|0.0472
91582333|NCT04617275|183055231|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0004|TWO_SIDED|90.0|-1.29|-0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.45|-1.29|0.0004
91582334|NCT04617275|183055231|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|90.0|-1.53|-0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.68|-1.53|<0.0001
91582335|NCT04617275|183055231|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.0003|TWO_SIDED|90.0|-1.36|-0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.50|-1.36|0.0003
91582336|NCT04617275|183055231|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.0004|TWO_SIDED|90.0|-1.34|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.34|0.0004
91582337|NCT04617275|183055232|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.0116|TWO_SIDED|90.0|-1.18|-0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.19|-1.18|0.0116
91582338|NCT04617275|183055232|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.0008|TWO_SIDED|90.0|-1.43|-0.46|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.43|0.0008
91582339|NCT04617275|183055232|SUPERIORITY||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.66|-0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.67|-1.66|<0.0001
91582340|NCT04617275|183055232|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0017|TWO_SIDED|90.0|-1.4|-0.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.40|-1.40|0.0017
91582341|NCT04617275|183055232|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.0004|TWO_SIDED|90.0|-1.55|-0.55||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.55|-1.55|0.0004
91582342|NCT04617275|183055233|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0132|TWO_SIDED|90.0|-1.32|-0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.20|-1.32|0.0132
91582343|NCT04617275|183055233|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.0014|TWO_SIDED|90.0|-1.55|-0.46||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.55|0.0014
91582344|NCT04617275|183055233|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.8|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.80|0.0002
91777380|NCT05179785|183435953|OTHER|||||||0.75948776|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.75948776
91582345|NCT04617275|183055233|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.0174|TWO_SIDED|90.0|-1.29|-0.16|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.16|-1.29|0.0174
91582346|NCT04617275|183055233|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.82|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.82|0.0002
91582347|NCT04617275|183055234|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2843|TWO_SIDED|90.0|-1.02|0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.50|-1.02|0.2843
91582348|NCT04617275|183055234|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.431|TWO_SIDED|90.0|-0.84|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-0.84|0.4310
91582349|NCT04617275|183055234|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.2402|TWO_SIDED|90.0|-1.07|0.43||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.43|-1.07|0.2402
91646423|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.2031|TWO_SIDED|95.0|0.73|4.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.30|0.73|0.2031
91646424|NCT01236053|183184711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4932|TWO_SIDED|95.0|0.56|3.37|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.37|0.56|0.4932
91582350|NCT04617275|183055234|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1397|TWO_SIDED|90.0|-1.24|0.26||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.26|-1.24|0.1397
91582351|NCT04617275|183055234|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.4393|TWO_SIDED|90.0|-0.85|0.71||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.71|-0.85|0.4393
91582352|NCT04617275|183055235|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.1491|TWO_SIDED|90.0|-2.0|0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.45|-2.00|0.1491
91582353|NCT04617275|183055235|SUPERIORITY||Median Difference (Final Values)|0.12||||0.5664|TWO_SIDED|90.0|-1.09|1.34||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.34|-1.09|0.5664
91582354|NCT04617275|183055235|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.0632|TWO_SIDED|90.0|-2.33|0.09||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.09|-2.33|0.0632
91582355|NCT04617275|183055235|SUPERIORITY||Median Difference (Final Values)|-1.01||||0.0847|TWO_SIDED|90.0|-2.23|0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.20|-2.23|0.0847
91582356|NCT04617275|183055235|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5264|TWO_SIDED|90.0|-1.2|1.3||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.30|-1.20|0.5264
91777381|NCT05179785|183435953|OTHER|||||||0.7238414|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.72384140
91777382|NCT05179785|183435953|OTHER|||||||0.00477281|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.00477281
91582357|NCT04617275|183055236|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.0395|TWO_SIDED|90.0|-2.86|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-2.86|0.0395
91582358|NCT04617275|183055236|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.3726|TWO_SIDED|90.0|-1.63|1.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.10|-1.63|0.3726
91582359|NCT04617275|183055236|SUPERIORITY||Mean Difference (Final Values)|-2.36||||0.0028|TWO_SIDED|90.0|-3.74|-0.98||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.98|-3.74|0.0028
91582360|NCT04617275|183055236|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.0139|TWO_SIDED|90.0|-3.23|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-3.23|0.0139
91582361|NCT04617275|183055236|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.1815|TWO_SIDED|90.0|-2.19|0.64||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.64|-2.19|0.1815
91582362|NCT04617275|183055237|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.0112|TWO_SIDED|90.0|-3.71|-0.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.61|-3.71|0.0112
91582363|NCT04617275|183055237|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.2161|TWO_SIDED|90.0|-2.24|0.8||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.80|-2.24|0.2161
91582364|NCT04617275|183055237|SUPERIORITY||Mean Difference (Final Values)|-3.47||||0.0002|TWO_SIDED|90.0|-5.02|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-5.02|0.0002
91582365|NCT04617275|183055237|SUPERIORITY||Mean Difference (Final Values)|-2.05||||0.0147|TWO_SIDED|90.0|-3.59|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-3.59|0.0147
91582366|NCT04617275|183055237|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.0013|TWO_SIDED|90.0|-4.56|-1.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.37|-4.56|0.0013
91582367|NCT04617275|183055238|SUPERIORITY||Mean Difference (Final Values)|-2.46||||0.0111|TWO_SIDED|90.0|-4.22|-0.7||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.70|-4.22|0.0111
91582368|NCT04617275|183055238|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.16|TWO_SIDED|90.0|-2.75|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-2.75|0.1600
91582369|NCT04617275|183055238|SUPERIORITY||Mean Difference (Final Values)|-4.27|||<|0.0001|TWO_SIDED|90.0|-6.03|-2.52||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.52|-6.03|<0.0001
91582370|NCT04617275|183055238|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0061|TWO_SIDED|90.0|-4.42|-0.94||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.94|-4.42|0.0061
91582371|NCT04617275|183055238|SUPERIORITY||Mean Difference (Final Values)|-3.71||||0.0005|TWO_SIDED|90.0|-5.52|-1.89||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.89|-5.52|0.0005
91582372|NCT04617275|183055239|SUPERIORITY||Mean Difference (Final Values)|-3.21||||0.0047|TWO_SIDED|90.0|-5.22|-1.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.20|-5.22|0.0047
91582373|NCT04617275|183055239|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.1003|TWO_SIDED|90.0|-3.45|0.44||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.44|-3.45|0.1003
91582374|NCT04617275|183055239|SUPERIORITY||Mean Difference (Final Values)|-4.95|||<|0.0001|TWO_SIDED|90.0|-6.96|-2.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.95|-6.96|<0.0001
91582375|NCT04617275|183055239|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0197|TWO_SIDED|90.0|-4.49|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-4.49|0.0197
91582376|NCT04617275|183055239|SUPERIORITY||Mean Difference (Final Values)|-4.94|||<|0.0001|TWO_SIDED|90.0|-7.03|-2.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.85|-7.03|<0.0001
91582377|NCT04617275|183055240|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.0836|TWO_SIDED|90.0|-2.12|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-2.12|0.0836
91582378|NCT04617275|183055241|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.0386|TWO_SIDED|90.0|-3.07|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-3.07|0.0386
91582379|NCT04617275|183055242|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.1566|TWO_SIDED|90.0|-3.99|1.0||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.00|-3.99|0.1566
91582380|NCT04617275|183055243|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.0916|TWO_SIDED|90.0|-5.91|0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.67|-5.91|0.0916
91582381|NCT04617275|183055244|SUPERIORITY||Mean Difference (Final Values)|-3.07||||0.059|TWO_SIDED|90.0|-6.31|0.17||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.17|-6.31|0.0590
91582382|NCT04617275|183055245|SUPERIORITY||Mean Difference (Final Values)|-3.74||||0.0826|TWO_SIDED|90.0|-8.23|0.75||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.75|-8.23|0.0826
91582383|NCT04227704|183055257|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
91582384|NCT04227704|183055258|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
91582385|NCT04227704|183055265|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
91582386|NCT02874924|183055409|EQUIVALENCE|Pilot study, therefore, no power calculation available.|Mean Difference (Net)|-1.81||||0.56|TWO_SIDED|95.0|-8.48|4.86|||t-test, 2 sided|||Null hypothesis||4.86|-8.48|0.56
91582387|NCT01874431|183055429|OTHER||Least square mean ratio|0.926||||0.1973|TWO_SIDED|90.0|0.799|1.074|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.||1.074|0.799|0.1973
91708341|NCT01763827|183309613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.57|STANDARD_ERROR_OF_MEAN|2.14|<|0.001|TWO_SIDED|95.0|-53.78|-45.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.36|-53.78|<0.001
91708342|NCT01763827|183309613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.77|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-57.28|-48.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-48.26|-57.28|<0.001
91708343|NCT01763827|183309613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.76|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-39.95|-31.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.57|-39.95|<0.001
91582388|NCT01874431|183055429|OTHER||Least square mean ratio|0.949||||0.2808|TWO_SIDED|90.0|0.818|1.101|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.101|0.818|0.2808
91582389|NCT01874431|183055429|OTHER||Least square mean ratio|0.878||||0.0723|TWO_SIDED|90.0|0.758|1.017|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.017|0.758|0.0723
91582390|NCT01874431|183055429|OTHER||Least square mean ratio|0.787||||0.0039|TWO_SIDED|90.0|0.68|0.912|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.912|0.68|0.0039
91582391|NCT01874431|183055429|OTHER||Least square mean ratio|0.755||||0.0009|TWO_SIDED|90.0|0.651|0.875|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.875|0.651|0.0009
91708344|NCT01763827|183309613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.97|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-38.48|-29.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.45|-38.48|<0.001
91708345|NCT01763827|183309614|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.48|||<|0.001|TWO_SIDED|95.0|-25.28|-11.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.68|-25.28|<0.001
91777383|NCT05179785|183435954|OTHER|||||||0.20047055|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20047055
91582392|NCT01874431|183055429|OTHER||Least square mean ratio|0.671|||<|0.0001|TWO_SIDED|90.0|0.584|0.772|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.772|0.584|< 0.0001
91613252|NCT01522651|183120986|OTHER|Pairwise Comparative analysis|Percentage Difference|8.8|STANDARD_ERROR_OF_MEAN|32.9||0.78|TWO_SIDED|95.0|-40.2|98.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||98.2|-40.2|0.780
91613253|NCT01522651|183120986|OTHER|Pairwise Comparative analysis|Percentage Difference|-57.0|STANDARD_ERROR_OF_MEAN|13.4||0.008|TWO_SIDED|95.0|-76.8|-20.1||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||-20.1|-76.8|0.008
91613254|NCT01522651|183120986|OTHER|Pairwise Comparative analysis|Percentage Difference|-42.6|STANDARD_ERROR_OF_MEAN|17.5||0.072|TWO_SIDED|95.0|-68.7|5.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||5.2|-68.7|0.072
91613255|NCT01522651|183120986|OTHER|Pairwise Comparative analysis||||||0.315||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.315
91613256|NCT01522651|183120986|OTHER|Pairwise Comparative analysis||||||0.049||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.049
91613257|NCT01522651|183120986|OTHER|Pairwise Comparative analysis||||||0.275||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.275
91613258|NCT01522651|183120986|OTHER|Pairwise Comparative analysis||||||0.002||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.002
91613259|NCT01522651|183120986|OTHER|Pairwise Comparative analysis||||||0.028||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.028
91582393|NCT01874431|183055429|OTHER||Least square mean ratio|0.624|||<|0.0001|TWO_SIDED|90.0|0.542|0.718|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.718|0.542|< 0.0001
91582394|NCT01874431|183055430|OTHER||Least squares mean difference|0.107||||0.0428|TWO_SIDED|95.0|0.003|0.21|||t-test, 2 sided|||||0.21|0.003|0.0428
91582395|NCT01874431|183055430|OTHER||Least squares mean difference|0.121||||0.0223|TWO_SIDED|95.0|0.017|0.225|||t-test, 2 sided|||||0.225|0.017|0.0223
91582396|NCT01874431|183055430|OTHER||Least squares mean difference|0.2||||0.0002|TWO_SIDED|95.0|0.096|0.305|||t-test, 2 sided|||||0.305|0.096|0.0002
91582397|NCT01874431|183055430|OTHER||Least squares mean difference|0.125||||0.0181|TWO_SIDED|95.0|0.021|0.229|||t-test, 2 sided|||||0.229|0.021|0.0181
91582398|NCT01874431|183055430|OTHER||Least squares mean difference|0.166||||0.0019|TWO_SIDED|95.0|0.061|0.27|||t-test, 2 sided|||||0.27|0.061|0.0019
91582399|NCT01874431|183055430|OTHER||Least squares mean difference|0.236|||<|0.0001|TWO_SIDED|95.0|0.137|0.334|||t-test, 2 sided|||||0.334|0.137|< 0.0001
91582400|NCT01874431|183055430|OTHER||Least squares mean difference|0.186||||0.0002|TWO_SIDED|95.0|0.088|0.284|||t-test, 2 sided|||||0.284|0.088|0.0002
91582401|NCT01874431|183055431|OTHER||Least squares mean difference|-0.786||||0.5454|TWO_SIDED|95.0|-3.337|1.765|||t-test, 2 sided|||||1.765|-3.337|0.5454
91582402|NCT01874431|183055431|OTHER||Least squares mean difference|-1.61||||0.2186|TWO_SIDED|95.0|-4.177|0.957|||t-test, 2 sided|||||0.957|-4.177|0.2186
91582403|NCT01874431|183055431|OTHER||Least squares mean difference|-0.918||||0.4859|TWO_SIDED|95.0|-3.503|1.667|||t-test, 2 sided|||||1.667|-3.503|0.4859
91582404|NCT01874431|183055431|OTHER||Least squares mean difference|-1.8||||0.1677|TWO_SIDED|95.0|-4.358|0.759|||t-test, 2 sided|||||0.759|-4.358|0.1677
91582405|NCT01874431|183055431|OTHER||Least squares mean difference|-2.613||||0.0462|TWO_SIDED|95.0|-5.183|-0.044|||t-test, 2 sided|||||-0.044|-5.183|0.0462
91582406|NCT01874431|183055431|OTHER||Least squares mean difference|-2.228||||0.0705|TWO_SIDED|95.0|-4.643|0.187|||t-test, 2 sided|||||0.187|-4.643|0.0705
91777384|NCT05179785|183435954|OTHER|||||||0.77922802|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.77922802
91777385|NCT05179785|183435954|OTHER|||||||0.29196708|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.29196708
91777386|NCT05179785|183435954|OTHER|||||||0.05605962|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.05605962
91777387|NCT05179785|183435954|OTHER|||||||0.57368284|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.57368284
91582407|NCT01874431|183055431|OTHER||Least squares mean difference|-2.446||||0.048|TWO_SIDED|95.0|-4.869|-0.022|||t-test, 2 sided|||||-0.022|-4.869|0.048
91582408|NCT01874431|183055432|OTHER||Least square mean difference|-2.863||||0.0757|TWO_SIDED|95.0|-6.022|0.297|||t-test, 2 sided|||||0.297|-6.022|0.0757
91582409|NCT01874431|183055432|OTHER||Least square mean difference|-0.643||||0.6941|TWO_SIDED|95.0|-3.851|2.565|||t-test, 2 sided|||||2.565|-3.851|0.6941
91582410|NCT01874431|183055432|OTHER||Least square mean difference|-1.976||||0.2228|TWO_SIDED|95.0|-5.155|1.203|||t-test, 2 sided|||||1.203|-5.155|0.2228
91582411|NCT01874431|183055432|OTHER||Least square mean difference|-1.932||||0.2313|TWO_SIDED|95.0|-5.098|1.234|||t-test, 2 sided|||||1.234|-5.098|0.2313
91582412|NCT01874431|183055432|OTHER||Least square mean difference|-3.342||||0.0386|TWO_SIDED|95.0|-6.509|-0.176|||t-test, 2 sided|||||-0.176|-6.509|0.0386
91582413|NCT01874431|183055432|OTHER||Least square mean difference|-0.634||||0.677|TWO_SIDED|95.0|-3.624|2.355|||t-test, 2 sided|||||2.355|-3.624|0.677
91582414|NCT01874431|183055432|OTHER||Least square mean difference|-0.688||||0.6536|TWO_SIDED|95.0|-3.699|2.322|||t-test, 2 sided|||||2.322|-3.699|0.6536
91582415|NCT01874431|183055433|OTHER||Least square mean difference|-3.044||||0.0816|TWO_SIDED|95.0|-6.471|0.383|||t-test, 2 sided|||||0.383|-6.471|0.0816
91582416|NCT01874431|183055433|OTHER||Least square mean difference|-0.537||||0.7625|TWO_SIDED|95.0|-4.027|2.953|||t-test, 2 sided|||||2.953|-4.027|0.7625
91582417|NCT01874431|183055433|OTHER||Least square mean difference|-1.301|||=|0.4603|TWO_SIDED|95.0|-4.759|2.157|||t-test, 2 sided|||||2.157|-4.759|= 0.4603
91582418|NCT01874431|183055433|OTHER||Least square mean difference|-1.574||||0.3678|TWO_SIDED|95.0|-5.004|1.855|||t-test, 2 sided|||||1.855|-5.004|0.3678
91582419|NCT01874431|183055433|OTHER||Least square mean difference|-1.727||||0.3279|TWO_SIDED|95.0|-5.191|1.736|||t-test, 2 sided|||||1.736|-5.191|0.3279
91582420|NCT01874431|183055433|OTHER||Least square mean difference|-1.682||||0.3102|TWO_SIDED|95.0|-4.935|1.57|||t-test, 2 sided|||||1.57|-4.935|0.3102
91582421|NCT01874431|183055433|OTHER||Least square mean difference|-2.511||||0.1317|TWO_SIDED|95.0|-5.778|0.755|||t-test, 2 sided|||||0.755|-5.778|0.1317
91582422|NCT02257567|183055457|SUPERIORITY||Difference in Response Rates|5.82||||0.5353|TWO_SIDED|95.0|-14.53|25.38|||Cochran-Mantel-Haenszel|||||25.38|-14.53|0.5353
91582423|NCT02257567|183055457|SUPERIORITY||Difference in Response Rates (4.89|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
91582424|NCT02257567|183055466|SUPERIORITY||Difference in Response Rates|0.69||||0.8817|TWO_SIDED|95.0|-19.68|20.86|||Cochran-Mantel-Haenszel|||||20.86|-19.68|0.8817
91582425|NCT02257567|183055466|SUPERIORITY||Difference in Response Rates|27.5||||0.0061|TWO_SIDED|95.0|7.66|44.74|||Cochran-Mantel-Haenszel|||||44.74|7.66|0.0061
91582426|NCT02257567|183055468|SUPERIORITY||Difference in Response Rates|-1.0||||0.9523|TWO_SIDED|95.0|-18.66|16.46|||Cochran-Mantel-Haenszel|||||16.46|-18.66|0.9523
91582427|NCT02257567|183055468|SUPERIORITY||Difference in Response Rates|30.0||||0.0036|TWO_SIDED|95.0|9.48|47.37|||Cochran-Mantel-Haenszel|||||47.37|9.48|0.0036
91582428|NCT02257567|183055469|SUPERIORITY||Difference in Response Rates|3.75||||0.6574|TWO_SIDED|95.0|-15.14|22.11|||Cochran-Mantel-Haenszel|||||22.11|-15.14|0.6574
91646425|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64||||0.0843|TWO_SIDED|95.0|0.88|7.96|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.96|0.88|0.0843
91646426|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.081|TWO_SIDED|95.0|0.88|8.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||8.28|0.88|0.0810
91646427|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4583|TWO_SIDED|95.0|0.55|3.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.70|0.55|0.4583
91646428|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4622|TWO_SIDED|95.0|0.55|3.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.73|0.55|0.4622
91646429|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.5512|TWO_SIDED|95.0|0.43|4.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.95|0.43|0.5512
91582429|NCT02257567|183055469|SUPERIORITY||Difference in Response Rates|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
91582430|NCT02257567|183055472|SUPERIORITY||Difference in Response Rates|3.88||||0.6225|TWO_SIDED|95.0|-14.49|21.72|||Cochran-Mantel-Haenszel|||||21.72|-14.49|0.6225
91582431|NCT02257567|183055472|SUPERIORITY||Difference in Response Rates|30.0||||0.0032|TWO_SIDED|95.0|9.94|47.12|||Cochran-Mantel-Haenszel|||||47.12|9.94|0.0032
91582432|NCT02257567|183055473|SUPERIORITY||Difference in Response Rates|-6.13||||0.4835|TWO_SIDED|95.0|-24.14|12.12|||Cochran-Mantel-Haenszel|||||12.12|-24.14|0.4835
91582433|NCT02257567|183055473|SUPERIORITY||Difference in Response Rates|25.0||||0.0096|TWO_SIDED|95.0|5.39|42.33|||Cochran-Mantel-Haenszel|||||42.33|5.39|0.0096
91582434|NCT02257567|183055474|SUPERIORITY||Difference in Response Rates|-0.5||||0.939|TWO_SIDED|95.0|-15.07|13.71|||Cochran-Mantel-Haenszel|||||13.71|-15.07|0.9390
91582435|NCT02257567|183055474|SUPERIORITY||Difference in Response Rates|37.5||||0.0006|TWO_SIDED|95.0|15.64|54.71|||Cochran-Mantel-Haenszel|||||54.71|15.64|0.0006
91646430|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9277|TWO_SIDED|95.0|0.31|3.67|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.67|0.31|0.9277
91777388|NCT05179785|183435954|OTHER|||||||0.56397238|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.56397238
91777389|NCT05179785|183435955|OTHER|||||||0.86107891|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.86107891
91777390|NCT05179785|183435955|OTHER|||||||0.62228799|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62228799
91777391|NCT05179785|183435955|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
91777392|NCT05179785|183435955|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
91582436|NCT02257567|183055475|SUPERIORITY||Difference in Response Rates|37.5||||0.0005|TWO_SIDED|95.0|15.82|54.62|||Cochran-Mantel-Haenszel|||||54.62|15.82|0.0005
91582437|NCT02257567|183055476|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0245|TWO_SIDED|95.0|0.19|0.91|||Log Rank|||||0.91|0.19|0.0245
91582438|NCT02257567|183055477|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.2451|TWO_SIDED|95.0|0.25|1.43|||Log Rank|||||1.43|0.25|0.2451
91582439|NCT02257567|183055478|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.2|0.56|||Log Rank|||||0.56|0.20|<.0001
91582440|NCT02257567|183055479|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0003|TWO_SIDED|95.0|0.23|0.66|||Log Rank|||||0.66|0.23|0.0003
91582441|NCT00946101|183055530|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.|rate difference|0.0|||||TWO_SIDED|95.0|-6.4|3.1|||score|||The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%||3.1|-6.4|
91582442|NCT00946101|183055531|SUPERIORITY_OR_OTHER||rate difference|1.5|||||TWO_SIDED|95.0|-12.8|9.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||9.8|-12.8|
91582443|NCT00946101|183055532|SUPERIORITY_OR_OTHER||rate difference|4.9|||||TWO_SIDED|95.0|-9.6|13.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||13.8|-9.6|
91582444|NCT00946101|183055533|SUPERIORITY_OR_OTHER||rate difference|17.5|||||TWO_SIDED|95.0|5.5|27.1|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||27.1|5.5|
91646431|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6402|TWO_SIDED|95.0|0.51|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.95|0.51|0.6402
91582445|NCT00946101|183055534|SUPERIORITY_OR_OTHER||rate difference|5.1|||||TWO_SIDED|95.0|-8.4|17.6|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||17.6|-8.4|
91582446|NCT00946101|183055537|SUPERIORITY_OR_OTHER||rate difference|13.3|||||TWO_SIDED|95.0|-0.4|25.7|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||25.7|-0.4|
91582447|NCT00946101|183055540|SUPERIORITY_OR_OTHER||rate difference|-6.3|||||TWO_SIDED|95.0|-19.7|6.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||6.1|-19.7|
91582448|NCT00946101|183055543|SUPERIORITY_OR_OTHER||rate difference|-6.4|||||TWO_SIDED|95.0|-20.3|7.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||7.1|-20.3|
91582449|NCT00946101|183055552|SUPERIORITY_OR_OTHER||rate difference|7.0|||||TWO_SIDED|95.0|-6.1|14.7|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||14.7|-6.1|
91582450|NCT00946101|183055553|SUPERIORITY_OR_OTHER||rate difference|7.2|||||TWO_SIDED|95.0|-5.8|15.1|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||15.1|-5.8|
91582451|NCT00946101|183055554|SUPERIORITY_OR_OTHER||rate difference|16.7|||||TWO_SIDED|95.0|5.9|25.2|||score|||The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||25.2|5.9|
91582452|NCT01288521|183055569|SUPERIORITY|The null hypothesis is that the tacrolimus biovailability alone is equal to the tacrolimus bioavailability when given with ketoconazole.||||||0.006|||||||Regression, Linear|The bioavailability with Tac alone vs. Tac +keto was compared using linear model adjusting for sex and creatinine clearance.||The bioavailability of Tac alone vs. Tac +keto was compared using a general linear model including sex and creatinine clearance as covariates.||||0.006
91582453|NCT02081417|183055570|NON_INFERIORITY|Based on the PCL-C if the interventions fell within 2.5 points of each other|Mean Difference (Net)|0.18||||0.01|TWO_SIDED|95.0|-3.4|3.8|||Mixed Models Analysis|||||3.8|-3.4|0.01
91582454|NCT03086213|183055585|NON_INFERIORITY|the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.|Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|0.025||0.025|TWO_SIDED|95.0|5.0|95.0||whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance|t-test, 2 sided|degrees of freedom|Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk|null hypothesis||95|5|0.025
91582455|NCT03086213|183055586|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level|||||<|0.05||||||the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.|t-test, 2 sided|degrees of freedom is defined as sample size subtraction one.||null hypothesis||||<0.05
91646432|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9256|TWO_SIDED|95.0|0.4|2.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.32|0.40|0.9256
91582456|NCT03086213|183055589|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level||||||0.05|||||||t-test, 2 sided|Degree of freedom is defined as sample size subtraction one.||null hypothesis||||0.05
91646433|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9514|TWO_SIDED|95.0|0.24|4.5|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.50|0.24|0.9514
91646434|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.7543|TWO_SIDED|95.0|0.18|3.44|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.44|0.18|0.7543
91582457|NCT01502631|183055591|SUPERIORITY||Least Squares (LS) Mean|5.61|STANDARD_ERROR_OF_MEAN|4.497||0.2182|TWO_SIDED|90.0|-1.93|13.14|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 2||13.14|-1.93|0.2182
91582458|NCT01502631|183055591|SUPERIORITY||Least Squares (LS) Mean|6.87|STANDARD_ERROR_OF_MEAN|5.583||0.226|TWO_SIDED|90.0|-2.54|16.27|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 4||16.27|-2.54|0.2260
91582459|NCT01502631|183055591|SUPERIORITY||Least Squares (LS) Mean|3.03|STANDARD_ERROR_OF_MEAN|6.023||0.6184|TWO_SIDED|90.0|-7.15|13.21|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 8||13.21|-7.15|0.6184
91582460|NCT01502631|183055591|SUPERIORITY||Least Squares (LS) Mean|4.54|STANDARD_ERROR_OF_MEAN|6.524||0.4912|TWO_SIDED|90.0|-6.48|15.56|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 16||15.56|-6.48|0.4912
91582461|NCT02319525|183055601|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
91582462|NCT02319525|183055602|SUPERIORITY_OR_OTHER|||||||0.08||||||We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.|Chi-squared|||||||0.08
91582463|NCT02319525|183055603|SUPERIORITY_OR_OTHER|||||||0.252|||||||Chi-squared|||We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.||||0.252
91582464|NCT02319525|183055604|SUPERIORITY_OR_OTHER|||||||0.504|||||||t-test, 2 sided|||||||0.504
91582465|NCT02319525|183055605|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
91582466|NCT02319525|183055606|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Impact of lupus nephritis"||||0.006
91582467|NCT02319525|183055606|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Risk factors"||||0.006
91646435|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8781|TWO_SIDED|95.0|0.38|3.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.07|0.38|0.8781
91777393|NCT05179785|183435955|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
91777394|NCT05179785|183435955|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
91777395|NCT05179785|183435955|OTHER|||||||0.62461968|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62461968
91777396|NCT05179785|183435955|OTHER|||||||0.51324793|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.51324793
91582468|NCT02319525|183055606|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the medication options"||||0.003
91582469|NCT02319525|183055606|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the evidence about medications"||||<0.001
91582470|NCT02319525|183055606|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the study about other patients"||||<0.001
91582471|NCT02319525|183055607|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||The test of significance compared all the rows, i.e., all response options for the statement.||||0.006
91582472|NCT01445301|183055644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|||<|0.001|TWO_SIDED|95.0|-15.0|-7.0|||ANCOVA|||||-7.0|-15.0|<0.001
91582473|NCT01445301|183055644|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-12.9|-3.6|||ANCOVA|||||-3.6|-12.9|<0.001
91582474|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.4|-1.5|||ANCOVA|||WEEK 1||-1.5|-4.4|<0.001
91613260|NCT01522651|183120986|OTHER|Pairwise Comparative analysis||||||0.334||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.334
91777397|NCT05179785|183435955|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
91777398|NCT05179785|183435955|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
91777399|NCT05179785|183435955|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
91777400|NCT05179785|183435955|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
91777401|NCT05179785|183435956|OTHER|||||||0.09266386|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.09266386
91646436|NCT01236053|183184713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7429|TWO_SIDED|95.0|0.29|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.40|0.29|0.7429
91646437|NCT02304302|183184716|SUPERIORITY||Mean Difference (Net)|0.34||||0.61|TWO_SIDED|95.0|-0.98|1.67|||Mixed Models Analysis|||||1.67|-0.98|0.61
91646438|NCT02304302|183184717|SUPERIORITY||Mean Difference (Net)|-0.32||||0.57|TWO_SIDED|95.0|-1.43|0.8|||Mixed Models Analysis|||||0.80|-1.43|0.57
91646439|NCT02304302|183184718|SUPERIORITY||Median Difference (Net)|-0.04||||0.91|TWO_SIDED|95.0|-0.74|0.66|||Mixed Models Analysis|||||0.66|-0.74|0.91
91646440|NCT02304302|183184719|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.91|0.91|||Mixed Models Analysis|||||0.91|-1.91|0.48
91777402|NCT05179785|183435956|OTHER|||||||0.53980185|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.53980185
91777403|NCT05179785|183435956|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
91777404|NCT05179785|183435956|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
91777405|NCT05179785|183435956|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
91777406|NCT05179785|183435956|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
91777407|NCT05179785|183435957|OTHER|||||||0.0265|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0265
91777408|NCT05179785|183435957|OTHER|||||||0.1053|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.1053
91777409|NCT05179785|183435957|OTHER|||||||0.0033|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0033
91777410|NCT01710345|183435958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|4.45||0.742|ONE_SIDED|95.0|||||ANCOVA|||||||0.742
91777411|NCT01710345|183435958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.66|STANDARD_ERROR_OF_MEAN|4.47||0.003|ONE_SIDED|95.0|||||ANCOVA|||||||0.003
91646441|NCT02304302|183184720|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5|TWO_SIDED|95.0|-5.14|2.53|||Mixed Models Analysis|||||2.53|-5.14|0.50
91646442|NCT02304302|183184721|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.52|0.32|||Mixed Models Analysis|||||0.32|-0.52|0.62
91777412|NCT02105740|183435980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|STANDARD_DEVIATION|1.178||0.034|TWO_SIDED|95.0|0.224|5.11|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.||5.110|0.224|0.034
91777413|NCT02105740|183435980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.66|STANDARD_DEVIATION|0.856||0.004|TWO_SIDED|95.0|1.253|6.08|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.||6.080|1.253|0.004
91777414|NCT02105740|183435980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.25|STANDARD_DEVIATION|0.827||0|TWO_SIDED|95.0|2.918|7.582|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.||7.582|2.918|0.000
91777415|NCT02105740|183435981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.||||
91777416|NCT02105740|183435981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.||||
91777417|NCT01075243|183435985|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.71||||0.0009|TWO_SIDED|95.0|1.53|5.89|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.||5.89|1.53|0.0009
91777418|NCT01075243|183435985|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.33|||<|0.0001|TWO_SIDED|95.0|8.66|14.0|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||14.00|8.66|<0.0001
91777419|NCT01075243|183435985|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.63|||<|0.0001||95.0|4.94|10.31|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 650 mg caplet and placebo caplet.||10.31|4.94|<0.0001
91777420|NCT00627393|183436000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|||3.20|0.44|0.73
91777421|NCT00627393|183436003|SUPERIORITY_OR_OTHER||Log Rank P-Value|0.43||||0.43|TWO_SIDED|||||Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).|Competing Risks|||||||0.43
91777422|NCT00627393|183436008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.293|STANDARD_ERROR_OF_MEAN|0.25885||0.35|TWO_SIDED|95.0|0.778|2.147|||Log Rank|Log-rank test to compare survival distributions between the control group and treatment group.|The control group is considered the reference group.|||2.147|0.778|0.35
91777423|NCT00551642|183436013|OTHER||Odds Ratio (OR)|1.05||||0.734|TWO_SIDED||||||Wald Chi-square|||||||0.7340
91777424|NCT03337308|183436016|SUPERIORITY||Difference of Least Squares (LS) means|-38.0|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-46.5|-29.6|||ANCOVA||Standard Error of the Difference of Least Squares (LS) Means|||-29.6|-46.5|<0.001
91582475|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-1.8||||0.113|TWO_SIDED|95.0|-4.0|0.4|||ANCOVA|||WEEK 2||0.4|-4.0|0.113
91582476|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.0||||0.084|TWO_SIDED|95.0|-4.2|0.3|||ANCOVA|||WEEK 4||0.3|-4.2|0.084
91582477|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.7||||0.026|TWO_SIDED|95.0|-5.1|-0.3|||ANCOVA|||WEEK 8||-0.3|-5.1|0.026
91582478|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.6||||0.03|TWO_SIDED|95.0|-5.0|-0.3|||ANCOVA|||WEEK 12||-0.3|-5.0|0.030
91582479|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-3.4||||0.028|TWO_SIDED|95.0|-6.5|-0.4|||ANCOVA|||WEEK 1||-0.4|-6.5|0.028
91582480|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.4||||0.004|TWO_SIDED|95.0|-9.1|-1.7|||ANCOVA|||WEEK 2||-1.7|-9.1|0.004
91582481|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Odds Ratio (OR)|-5.8||||0.003|TWO_SIDED|95.0|-9.6|-1.9|||ANCOVA|||WEEK 4||-1.9|-9.6|0.003
91582482|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.5||||0.006|TWO_SIDED|95.0|-9.4|-1.6|||ANCOVA|||WEEK 8||-1.6|-9.4|0.006
91582483|NCT01445301|183055646|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.5|-1.7|||ANCOVA|||WEEK 12||-1.7|-9.5|0.005
91582484|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.9|-1.1|||ANCOVA|||WEEK 1||-1.1|-3.9|<0.001
91582485|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.7|-1.6|||ANCOVA|||WEEK 2||-1.6|-4.7|<0.001
91582486|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-2.5||||0.002|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||WEEK 4||-0.9|-4.1|0.002
91582487|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-2.7||||0.003|TWO_SIDED|95.0|-4.5|-0.9|||ANCOVA|||WEEK 8||-0.9|-4.5|0.003
91582488|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-2.8||||0.002|TWO_SIDED|95.0|-4.6|-1.0|||ANCOVA|||WEEK 12||-1.0|-4.6|0.002
91777425|NCT03337308|183436016|SUPERIORITY||Difference of LS means|-19.0|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-26.1|-11.9|||ANCOVA||Standard Error of the Difference of LS Means|||-11.9|-26.1|<0.001
91582489|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.8|-3.2|||ANCOVA|||WEEK 1||-3.2|-8.8|<0.001
91582490|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-11.4|-4.7|||ANCOVA|||WEEK 2||-4.7|-11.4|<0.001
91582491|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-9.7|||<|0.001|TWO_SIDED|95.0|-13.1|-6.2|||ANCOVA|||WEEK 4||-6.2|-13.1|<0.001
91582492|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-8.6|||<|0.001|TWO_SIDED|95.0|-12.1|-5.1|||ANCOVA|||WEEK 8||-5.1|-12.1|<0.001
91582493|NCT01445301|183055646|SUPERIORITY||Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.6|-4.8|||ANCOVA|||WEEK 12||-4.8|-11.6|<0.001
91582494|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.71|||<|0.001|TWO_SIDED|95.0|-11.3|-4.12|||ANCOVA|||Total Lesion Counts, WEEK 1||-4.12|-11.30|<0.001
91582495|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.51|||<|0.001|TWO_SIDED|95.0|-13.24|-3.77|||ANCOVA|||Total Lesion Counts, WEEK 2||-3.77|-13.24|<0.001
91582496|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.89|||<|0.001|TWO_SIDED|95.0|-13.37|-4.41|||ANCOVA|||Total Lesion Counts, WEEK 4||-4.41|-13.37|<0.001
91582497|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.12|||<|0.001|TWO_SIDED|95.0|-13.82|-4.43|||ANCOVA|||Total Lesion Counts, WEEK 8||-4.43|-13.82|<0.001
91582498|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.43|||<|0.001|TWO_SIDED|95.0|-14.11|-4.75|||ANCOVA|||Total Lesion Counts, WEEK 12||-4.75|-14.11|<0.001
91646443|NCT02304302|183184722|SUPERIORITY||Mean Difference (Net)|2.94||||0.84|TWO_SIDED|95.0|-25.32|31.2|||Mixed Models Analysis|||||31.20|-25.32|0.84
91777426|NCT03337308|183436016|SUPERIORITY||Difference of LS means|-13.1|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.7|-6.5|||ANCOVA||Standard Error of the Difference of LS Means|||-6.5|-19.7|<0.001
91777427|NCT03337308|183436017|SUPERIORITY||Location shift|-46.1|STANDARD_ERROR_OF_MEAN|12.22|<|0.001|TWO_SIDED|99.0|-78.75|-15.78||using alpha = 0.01|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-15.78|-78.75|<0.001
91582499|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-10.54|||<|0.001|TWO_SIDED|95.0|-15.12|-5.97|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-5.97|-15.12|<0.001
91582500|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.21||||0.011|TWO_SIDED|95.0|-12.73|-1.69|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-1.69|-12.73|0.011
91582501|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-7.64||||0.005|TWO_SIDED|95.0|-12.93|-2.35|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-2.35|-12.93|0.005
91582502|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.73||||0.002|TWO_SIDED|95.0|-14.2|-3.26|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.26|-14.20|0.002
91582503|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.2||||0.002|TWO_SIDED|95.0|-13.34|-3.06|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-3.06|-13.34|0.002
91582504|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-5.8||||0.011|TWO_SIDED|95.0|-10.29|-1.32|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-1.32|-10.29|0.011
91582505|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.3||||0.005|TWO_SIDED|95.0|-14.1|-2.5|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-2.50|-14.10|0.005
91582506|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.27|||<|0.001|TWO_SIDED|95.0|-14.72|-3.83|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-3.83|-14.72|<0.001
91582507|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.84||||0.002|TWO_SIDED|95.0|-14.28|-3.39|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-3.39|-14.28|0.002
91582508|NCT01445301|183055647|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.68|||<|0.001|TWO_SIDED|95.0|-15.06|-4.3|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-4.30|-15.06|<0.001
91582509|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-12.32|-5.48|||ANCOVA|||Total Lesion Counts, WEEK 1||-5.48|-12.32|<0.001
91582510|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-11.17|||<|0.001|TWO_SIDED|95.0|-15.18|-7.16|||ANCOVA|||Total Lesion Counts, WEEK 2||-7.16|-15.18|<0.001
91582511|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-12.12|||<|0.001|TWO_SIDED|95.0|-15.9|-8.35|||ANCOVA|||Total Lesion Counts, WEEK 4||-8.35|-15.90|<0.001
91582512|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-11.33|||<|0.001|TWO_SIDED|95.0|-15.37|-7.3|||ANCOVA|||Total Lesion Counts, WEEK 8||-7.30|-15.37|<0.001
91582513|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-15.11|-7.25|||ANCOVA|||Total Lesion Counts, WEEK 12||-7.25|-15.11|<0.001
91582514|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-8.32|||<|0.001|TWO_SIDED|95.0|-12.76|-3.88|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-3.88|-12.76|<0.001
91582515|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-9.57|||<|0.001|TWO_SIDED|95.0|-13.83|-5.3|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-5.30|-13.83|<0.001
91646444|NCT02304302|183184723|SUPERIORITY||Mean Difference (Net)|-3.04||||0.24|TWO_SIDED|95.0|||||ANOVA|||QTc interval duration was the independent variable, treatment and time were the categorical factors.||||0.24
91582516|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-7.83|||<|0.001|TWO_SIDED|95.0|-12.03|-3.62|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-3.62|-12.03|<0.001
91582517|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-8.08|||<|0.001|TWO_SIDED|95.0|-12.63|-3.53|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.53|-12.63|<0.001
91582518|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-8.56|||<|0.001|TWO_SIDED|95.0|-12.71|-4.41|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-4.41|-12.71|<0.001
91582519|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-9.11|||<|0.001|TWO_SIDED|95.0|-13.53|-4.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-4.68|-13.53|<0.001
91582520|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-11.05|||<|0.001|TWO_SIDED|95.0|-16.3|-5.8|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-5.80|-16.30|<0.001
91582521|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-14.17|||<|0.001|TWO_SIDED|95.0|-18.97|-9.37|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-9.37|-18.97|<0.001
91582522|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-13.04|||<|0.001|TWO_SIDED|95.0|-17.83|-8.25|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-8.25|-17.83|<0.001
91582523|NCT01445301|183055647|SUPERIORITY||Mean Difference (Net)|-12.37|||<|0.001|TWO_SIDED|95.0|-17.05|-7.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-7.68|-17.05|<0.001
91582524|NCT01445301|183055648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91582525|NCT01445301|183055648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91646445|NCT02304302|183184724|SUPERIORITY||Mean Difference (Net)|1.91||||0.28|TWO_SIDED|95.0|-1.57|5.39|||Mixed Models Analysis|||||5.39|-1.57|0.28
91646446|NCT02304302|183184725|SUPERIORITY||Mean Difference (Net)|0.4||||0.51|TWO_SIDED|95.0|-0.8|1.61|||Mixed Models Analysis|||||1.61|-0.80|0.51
91646447|NCT02304302|183184726|SUPERIORITY||Mean Difference (Net)|1.17||||0.63|TWO_SIDED|95.0|-3.6|5.94|||Mixed Models Analysis|||||5.94|-3.6|0.63
91582526|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1||||0.470
91582527|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2||||0.844
91582528|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4||||0.022
91582529|NCT01445301|183055649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
91582530|NCT01445301|183055649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
91582531|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.572||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1||||0.572
91582532|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2||||0.335
91582533|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4||||0.187
91646448|NCT02304302|183184727|SUPERIORITY||Mean Difference (Net)|-3.65||||0.17|TWO_SIDED|95.0|-8.91|1.61|||Mixed Models Analysis|||||1.61|-8.91|0.17
91646449|NCT03078192|183184753|OTHER|Detecting pre-capillary PH was tested with a cohort of 32 patients. True PH status was based on RHC. A diagnosis of PH was established from mPAP \>20mmHg, while pre-capillary PH required PCWP ≤ 15mmHg and PVR ≥ 3 Woods Units, and post capillary PH required PCWP \> 15mmH and PVR \< 3 Woods Units \[21\]. Patients with both high PVR and PCWP \> 15mmHg were classified as combined pre- and post-capillary PH (CpcPH). Subjects with CpcPH were treated as positive for both pre- and post-capillary PH.|positive predictive value|0.86|||||TWO_SIDED|||||Positive predictive value for Precapillary Pulmonary Hypertension: 86%|calculation of PPV|||||||
91708346|NCT01763827|183309614|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-19.24|||<|0.001|TWO_SIDED|95.0|-23.2|-15.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-15.28|-23.20|<0.001
91708347|NCT01763827|183309614|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.37|||<|0.001|TWO_SIDED|95.0|-24.39|-12.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.35|-24.39|<0.001
91708348|NCT01763827|183309614|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.15|||<|0.001|TWO_SIDED|95.0|-23.23|-11.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.08|-23.23|<0.001
91777428|NCT03337308|183436017|SUPERIORITY||Median Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|8.14||0.002|TWO_SIDED|98.0|-45.0|-7.15||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-7.15|-45.00|0.002
91777429|NCT03337308|183436017|SUPERIORITY||Median Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|8.08||0.734|TWO_SIDED|98.0|-21.35|16.25||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||16.25|-21.35|0.734
91582534|NCT01445301|183055649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8||||<0.001
91582535|NCT01445301|183055649|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12||||0.006
91582536|NCT01445301|183055650|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1||||0.002
91708349|NCT01763827|183309615|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-27.76|-13.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-13.06|-27.76|<0.001
91582537|NCT01445301|183055650|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2||||<0.001
91582538|NCT01445301|183055650|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4||||<0.001
91582539|NCT01445301|183055650|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
91582540|NCT01445301|183055650|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
91582541|NCT01445301|183055650|SUPERIORITY_OR_OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 1||||0.480
91582542|NCT01445301|183055650|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 2||||<0.001
91708350|NCT01763827|183309615|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.82|||<|0.001|TWO_SIDED|95.0|-24.51|-11.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.12|-24.51|<0.001
91777430|NCT03337308|183436018|SUPERIORITY|using alpha = 0.01|Difference in LS mean|-33.7|STANDARD_ERROR_OF_MEAN|3.97|<|0.001|TWO_SIDED|99.0|-43.9|-23.4|||ANCOVA||Standard Error of the Difference of LS Means|||-23.4|-43.9|<0.001
91777431|NCT03337308|183436018|SUPERIORITY||Difference in LS means|-17.8|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|98.0|-25.1|-10.5||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-10.5|-25.1|<0.001
91777432|NCT03337308|183436018|SUPERIORITY||Difference in LS means|-12.1|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|98.0|-19.1|-5.0||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.0|-19.1|<0.001
91582543|NCT01445301|183055650|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 4||||0.009
91582544|NCT01445301|183055650|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 8||||0.008
91582545|NCT01445301|183055650|SUPERIORITY_OR_OTHER|||||||0.065|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 12||||0.065
91582546|NCT00190749|183055678|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for change to last observation|t-test, 2 sided|||||||0.226
91582547|NCT00190749|183055678|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value is change to last observation|t-test, 2 sided|||||||0.030
91582548|NCT00190749|183055678|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value for change to last observation.|ANCOVA|||||||0.204
91582549|NCT00190749|183055679|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||Pearson's correlation coefficient|||||||0.184
91582550|NCT00190749|183055679|SUPERIORITY_OR_OTHER|||||||0.295||95.0|||||Pearson's correlation coefficient|||||||0.295
91582551|NCT00190749|183055680|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Pearson's correlation coefficient|||||||0.256
91582552|NCT00190749|183055680|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Pearson's correlation coefficient|||||||0.277
91582553|NCT00190749|183055681|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||Pearson's correlation coefficient|||||||0.766
91582554|NCT00190749|183055681|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Pearson's correlation coefficient|||||||0.622
91582555|NCT00190749|183055682|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||Pearson's correlation coefficient|||||||0.829
91582556|NCT00190749|183055682|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Pearson's correlation coefficient|||||||0.714
91582557|NCT00190749|183055683|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||Pearson's correlation coefficient|||||||0.672
91582558|NCT00190749|183055683|SUPERIORITY_OR_OTHER|||||||0.191||95.0|||||Pearson's correlation coefficient|||||||0.191
91582559|NCT00190749|183055684|SUPERIORITY_OR_OTHER|||||||0.994||95.0|||||Pearson's correlation coefficient|||||||0.994
91582560|NCT00190749|183055684|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Pearson's correlation coefficient|||||||0.456
91582561|NCT00190749|183055685|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||Pearson's correlation coefficient|||||||0.454
91582562|NCT00190749|183055685|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||Pearson's correlation coefficient|||||||0.974
91582563|NCT00190749|183055686|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Pearson's correlation coefficient|||||||0.249
91582564|NCT00190749|183055686|SUPERIORITY_OR_OTHER|||||||0.163||95.0|||||Pearson's correlation coefficient|||||||0.163
91582565|NCT00190749|183055687|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Pearson's correlation coefficient|||||||0.201
91582566|NCT00190749|183055687|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Pearson's correlation coefficient|||||||0.168
91582567|NCT00190749|183055688|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||Pearson's correlation coefficient|||||||0.793
91582568|NCT00190749|183055688|SUPERIORITY_OR_OTHER|||||||0.777||95.0|||||Pearson's correlation coefficient|||||||0.777
91582569|NCT00190749|183055689|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Pearson's correlation coefficient|||||||0.815
91582570|NCT00190749|183055689|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||||||0.675
91582571|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.393
91582572|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.033
91582573|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.392||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.392
91777433|NCT03337308|183436019|SUPERIORITY||Difference of LS means|-27.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|99.0|-35.1|-19.1||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-19.1|-35.1|<0.001
91582574|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.129
91582575|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 3||||0.956
91582576|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 3||||0.846
91582577|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.675
91582578|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.306
91582579|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.468
91582580|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.739
91582581|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.404
91582582|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.711
91582583|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.281
91582584|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.805
91582585|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 8||||0.844
91582586|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 8||||0.359
91582587|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.642
91582588|NCT00190749|183055690|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.043
91582589|NCT00190749|183055691|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on Least Squares Mean (LSMean) change||||||<.001
91582590|NCT00190749|183055691|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.019
91582591|NCT00190749|183055691|SUPERIORITY_OR_OTHER|||||||0.065||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||||||0.065
91582592|NCT00190749|183055692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||<.001
91582593|NCT00190749|183055692|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.013
91582594|NCT00190749|183055692|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.076
91582595|NCT00190749|183055693|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.007
91777434|NCT03337308|183436019|SUPERIORITY||Difference of LS means|-14.2|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|98.0|-20.4|-8.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-8.1|-20.4|<0.001
91582596|NCT00190749|183055693|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.266
91582597|NCT00190749|183055693|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.239
91582598|NCT00190749|183055694|SUPERIORITY_OR_OTHER|||||||0.274||95.0|||||t-test, 2 sided|Within group p-vales are from t-tests on LSMean change||||||0.274
91582599|NCT00190749|183055694|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change.||||||0.105
91582600|NCT00190749|183055694|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.609
91582601|NCT00190749|183055695|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||0.406
91582602|NCT00190749|183055695|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.011
91582603|NCT00190749|183055695|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.076
91582604|NCT00190749|183055696|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.456
91646450|NCT01311505|183184754|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.9|||||TWO_SIDED|90.0|92.98|105.2||||||20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||105.20|92.98|
91646451|NCT01311505|183184755|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.24|||||TWO_SIDED|90.0|87.77|109.97||||||20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||109.97|87.77|
91646452|NCT01311505|183184757|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.25|||||TWO_SIDED|90.0|94.44|106.41||||||Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||106.41|94.44|
91646453|NCT00532779|183184774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.67|||<|0.001||95.0|-4.5|-2.85|||ANCOVA|||||-2.85|-4.50|<0.001
91646454|NCT00532779|183184774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|||<|0.001|TWO_SIDED|95.0|-5.63|-3.99|||ANCOVA|||||-3.99|-5.63|<0.001
91646455|NCT00532779|183184775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001||95.0|2.52|4.63|||Regression, Logistic|||||4.63|2.52|<0.001
91646456|NCT00532779|183184775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.86|||<|0.001||95.0|3.6|6.57|||Regression, Logistic|||||6.57|3.60|<0.001
91646457|NCT00532779|183184776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.14|4.81|||Regression, Logistic|||||4.81|2.14|<0.001
91646458|NCT00532779|183184776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.001|TWO_SIDED|95.0|2.82|6.23|||Regression, Logistic|||||6.23|2.82|<0.001
91646459|NCT00532779|183184777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.74|-1.43|||ANCOVA|||||-1.43|-3.74|<0.001
91646460|NCT00532779|183184777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.78|||<|0.001|TWO_SIDED|95.0|-4.93|-2.64|||ANCOVA|||||-2.64|-4.93|<0.001
91646461|NCT00532779|183184778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|||<|0.001|TWO_SIDED|95.0|2.17|4.66|||ANCOVA|||||4.66|2.17|<0.001
91646462|NCT00532779|183184778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.48|||<|0.001|TWO_SIDED|95.0|2.26|4.7|||ANCOVA|||||4.70|2.26|<0.001
91646463|NCT00532779|183184779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.88|||=|0.046|TWO_SIDED||||||ANCOVA|||||||=0.046
91646464|NCT00532779|183184779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.61|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91646465|NCT00532779|183184780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13|||<|0.001|TWO_SIDED|95.0|1.72|4.54|||ANCOVA|||||4.54|1.72|<0.001
91646466|NCT00532779|183184780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.14|||<|0.001|TWO_SIDED|95.0|2.73|5.56|||ANCOVA|||||5.56|2.73|<0.001
91646467|NCT00532779|183184781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.36|||=|0.016|TWO_SIDED||||||ANCOVA|||||||=0.016
91646468|NCT00532779|183184781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|||=|0.008|TWO_SIDED||||||ANCOVA|||||||=0.008
91646469|NCT00532779|183184782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.27|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
91646470|NCT00532779|183184782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.57|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91646471|NCT00532779|183184783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-2.6|0.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.42|-2.60|
91777435|NCT03337308|183436019|SUPERIORITY||Difference of LS means|-10.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|98.0|-16.1|-4.6||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-4.6|-16.1|<0.001
91582605|NCT00190749|183055696|SUPERIORITY_OR_OTHER|||||||0.712||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.712
91777436|NCT03337308|183436020|SUPERIORITY||Difference of LS means|-30.1|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|99.0|-39.9|-20.3||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-20.3|-39.9|<0.001
91777437|NCT03337308|183436020|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|98.0|-20.3|-5.3||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.3|-20.3|<0.001
91777438|NCT03337308|183436020|SUPERIORITY||Difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.09||0.003|TWO_SIDED|98.0|-16.5|-2.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-2.1|-16.5|0.003
91777439|NCT01294553|183436030|SUPERIORITY_OR_OTHER||Percentage of participants|15.4|||||TWO_SIDED|95.0|12.8|18.1|||||The estimated value represents the percentage of participants with an adverse event.|||18.1|12.8|
91777440|NCT00795535|183436041|SUPERIORITY_OR_OTHER||||||<|0.15|TWO_SIDED|||||To avoid overfitting the models, only predictors with p\<0.15 were included in the final models.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.||||< 0.15
91777441|NCT01903460|183436044|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-40.707||||0.574|TWO_SIDED|95.0|-191.679|110.265|||ANCOVA|||Analysis of LUM001 140ug/kg/day||110.265|-191.679|0.5740
91777442|NCT01903460|183436044|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-7.231||||0.9147|TWO_SIDED|95.0|-148.726|134.264|||ANCOVA|||Analysis of LUM001 280ug/kg/day||134.264|-148.726|0.9147
91777443|NCT01903460|183436044|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-23.969||||0.6954|TWO_SIDED|95.0|-151.969|104.031|||ANCOVA|||Analysis of all doses of LUM001||104.031|-151.969|0.6954
91777444|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|56.7||||0.0783|TWO_SIDED|95.0|-7.2|120.6|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALT||120.6|-7.2|0.0783
91777445|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|7.8||||0.7827|TWO_SIDED|95.0|-51.4|67.0|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALT||67.0|-51.4|0.7827
91777446|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|32.2||||0.2235|TWO_SIDED|95.0|-21.9|86.3|||ANCOVA|||Analysis of all doses of LUM001 for ALT||86.3|-21.9|0.2235
91777447|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|24.0||||0.2372|TWO_SIDED|95.0|-17.5|65.5|||ANCOVA|||Analysis of LUM001 140ug/kg/day for AST||65.5|-17.5|0.2372
91777448|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-15.8||||0.3914|TWO_SIDED|95.0|-54.1|22.4|||ANCOVA|||Analysis of LUM001 280ug/kg/day for AST||22.4|-54.1|0.3914
91777449|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|4.1||||0.8081|TWO_SIDED|95.0|-31.0|39.1|||ANCOVA|||Analysis of all doses of LUM001 for AST||39.1|-31.0|0.8081
91777450|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|51.7||||0.5748|TWO_SIDED|95.0|-140.3|243.7|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALP||243.7|-140.3|0.5748
91777451|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|11.9||||0.8835|TWO_SIDED|95.0|-158.4|182.2|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALP||182.2|-158.4|0.8835
91777452|NCT01903460|183436045|SUPERIORITY_OR_OTHER||LS mean difference from placebo|31.8||||0.6917|TWO_SIDED|95.0|-135.8|199.4|||ANCOVA|||Analysis of all doses of LUM001 for ALP||199.4|-135.8|0.6917
91777453|NCT01903460|183436046|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.348||||0.6907|TWO_SIDED|95.0|-2.468|1.772|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Patient ItchRO||1.772|-2.468|0.6907
91777454|NCT01903460|183436046|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.202||||0.7897|TWO_SIDED|95.0|-1.647|2.052|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Patient ItchRO||2.052|-1.647|0.7897
91777455|NCT01903460|183436046|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.073||||0.9203|TWO_SIDED|95.0|-1.85|1.705|||ANCOVA|||Analysis of all doses of LUM001 for Patient ItchRO||1.705|-1.850|0.9203
91777456|NCT01903460|183436046|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.21||||0.5966|TWO_SIDED|95.0|-1.038|0.618|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Observer ItchRO||0.618|-1.038|0.5966
91777457|NCT01903460|183436046|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.173||||0.632|TWO_SIDED|95.0|-0.58|0.926|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Observer ItchRO||0.926|-0.580|0.6320
91777458|NCT01903460|183436046|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.019||||0.9547|TWO_SIDED|95.0|-0.71|0.673|||ANCOVA|||Analysis of all doses of LUM001 for Observer ItchRO||0.673|-0.710|0.9547
91777459|NCT00829426|183436079|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|Geometric Test/Ref Ratio x 100|102.56|||||TWO_SIDED|90.0|98.74|106.52|||||Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|||106.52|98.74|
91777460|NCT00829426|183436080|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|92.88||||||90.0|90.34|95.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||95.48|90.34|
91777461|NCT00829426|183436081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|93.92||||||90.0|91.47|96.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||96.44|91.47|
91777462|NCT04408989|183436082|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.943|||||TWO_SIDED|90.0|0.899|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.899|
91582606|NCT00190749|183055696|SUPERIORITY_OR_OTHER|||||||0.689||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.689
91582607|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean||Total Score||||0.111
91582608|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean changes||Total Score||||0.159
91582609|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.951||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Total Score||||0.951
91582610|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Positive Subscale||||0.012
91582611|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean||Positive subscale||||0.002
91777463|NCT04408989|183436082|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.0|||||TWO_SIDED|90.0|0.956|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.956|
91777464|NCT04408989|183436082|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.01|1.12|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.12|1.01|
91777465|NCT04408989|183436083|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.937|||||TWO_SIDED|90.0|0.887|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.887|
91777466|NCT04408989|183436083|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.983|||||TWO_SIDED|90.0|0.925|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.925|
91777467|NCT04408989|183436083|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.991|1.11|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.11|0.991|
91777468|NCT00311766|183436101|SUPERIORITY_OR_OTHER||ANCOVA|0.8|||>|0.05|TWO_SIDED|95.0|||||Fisher Exact|||The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded||||>0.05
91777469|NCT02260934|183436103|SUPERIORITY|||||||0.58||||||Two-sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 24||||0.58
91777470|NCT02260934|183436103|SUPERIORITY|||||||0.25||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 48||||0.25
91777471|NCT02260934|183436103|SUPERIORITY|||||||0.15||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 96.||||0.15
91777472|NCT02260934|183436105|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms.|||||||||||||Regression, Logistic|Two sided test. P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 24|Treatment group was the independent variable in the logistic regression.|||
91582612|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.467||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Positive subscale||||0.467
91582613|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.365||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||Negative subscale||||0.365
91582614|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Negative subscale||||0.846
91582615|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Negative subscale||||0.559
91582616|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.150
91582617|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.612
91582618|NCT00190749|183055697|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Anxiety-Depression subscale||||0.475
91582619|NCT00190749|183055698|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Within group p-values are from t-tests on LSMean change|t-test, 2 sided|||||||.012
91582620|NCT00190749|183055698|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.010
91582621|NCT00190749|183055698|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.760
91582622|NCT00190749|183055699|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.943
91582623|NCT00190749|183055699|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.763
91646472|NCT00532779|183184783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94|||=|0.01|TWO_SIDED|95.0|-3.42|-0.46|||ANCOVA|||||-0.46|-3.42|=0.010
91646473|NCT00532779|183184784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.43|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
91582624|NCT00190749|183055699|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.832
91582625|NCT00190749|183055700|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.623
91582626|NCT00190749|183055700|SUPERIORITY_OR_OTHER|||||||0.853||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.853
91582627|NCT00190749|183055700|SUPERIORITY_OR_OTHER|||||||0.591||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.591
91582628|NCT00190749|183055701|SUPERIORITY_OR_OTHER|||||||0.302||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.302
91582629|NCT00190749|183055701|SUPERIORITY_OR_OTHER|||||||0.922||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.922
91582630|NCT00190749|183055701|SUPERIORITY_OR_OTHER|||||||0.479||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.479
91582631|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.004
91582632|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.001
91582633|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 1||||0.549
91582634|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.011
91582635|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.009
91582636|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 2||||0.793
91582637|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.045
91582638|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.027
91646474|NCT00532779|183184784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.29|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91777473|NCT02260934|183436105|SUPERIORITY||||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 48|P-value could not be produced because of zero count in at least one of the treatment arms.|||
91582639|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.699||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 3||||0.699
91582640|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 4||||0.002
91582641|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||ITem 4||||0.019
91582642|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 4||||0.733
91582643|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.034
91777474|NCT02260934|183436105|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms|||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms||Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|P-value could not be produced because of zero count in at least one of the treatment arms|||
91777475|NCT02260934|183436106|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.66||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 24||||0.66
91582644|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.235
91582645|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 5||||0.532
91582646|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.242||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.242
91582647|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.186
91582648|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 6||||0.799
91582649|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.097
91582650|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.214
91582651|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 7||||0.827
91582652|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.151
91582653|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.071
91582654|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 8||||0.629
91582655|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.036
91582656|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.112
91582657|NCT00190749|183055702|SUPERIORITY_OR_OTHER|||||||0.806||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 9||||0.806
91582658|NCT00190749|183055703|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.156
91582659|NCT00190749|183055703|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.829
91582660|NCT00190749|183055703|SUPERIORITY_OR_OTHER|||||||0.352||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.352
91582661|NCT00190749|183055704|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.740
91582662|NCT00190749|183055704|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|Within group p-values are frm t-tests on LSMean change||||||0.760
91582663|NCT00190749|183055704|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.997
91582664|NCT00190749|183055705|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.176
91582665|NCT00190749|183055705|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.237
91582666|NCT00190749|183055705|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.996
91582667|NCT00190749|183055706|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.027
91582668|NCT00190749|183055706|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.545
91582669|NCT00190749|183055706|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.024
91582670|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.009
91582671|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.959
91582672|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator|ANCOVA|||HDL particles, total||||0.038
91582673|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.013
91646475|NCT00532779|183184785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.81|||||TWO_SIDED|95.0|-6.68|-0.94||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.94|-6.68|
91582674|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.928
91582675|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||IDL||||0.049
91582676|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.009
91582677|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.662||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.662
91582678|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Medium small LDL||||0.12
91582679|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.099
91582680|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.304||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.304
91582681|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Small LDL||||0.024
91582682|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Very small LDL||||0.176
91582683|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|Withn group p-values are from t-tests on LSMean change||Very small LDL||||0.246
91582684|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|ANCOVA|||Very small LDL||||0.033
91582685|NCT00190749|183055707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||<0.001
91582686|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||0.047
91582687|NCT00190749|183055707|SUPERIORITY_OR_OTHER|||||||0.221||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||VLDL mean particle size||||0.221
91582688|NCT04493502|183055709|SUPERIORITY||Mean Difference (Final Values)|17.1||||0.189|TWO_SIDED|95.0|-7.3|41.4|||Regression, Logistic|||||41.4|-7.3|0.189
91582689|NCT04493502|183055710|SUPERIORITY||Mean Difference (Final Values)|-4.67||||0.024|TWO_SIDED|95.0|-8.69|-0.64|||ANCOVA|||||-0.64|-8.69|0.024
91582690|NCT04493502|183055711|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.949|TWO_SIDED|95.0|-1.44|1.53|||ANCOVA|||||1.53|-1.44|0.949
91582691|NCT02891408|183055712|OTHER||Geometric least-square mean (GLSM) ratio|181.0|||||TWO_SIDED|90.0|98.0|332.0||||||AUClast of Firsocostat||332|98|
91582692|NCT02891408|183055712|OTHER||GLSM ratio|881.0|||||TWO_SIDED|90.0|488.0|1589.0||||||AUClast of Firsocostat||1589|488|
91582693|NCT02891408|183055712|OTHER||GLSM ratio|3081.0|||||TWO_SIDED|90.0|2446.0|3881.0||||||AUClast of Firsocostat||3881|2446|
91582694|NCT02891408|183055712|OTHER||GLSM ratio|430.0|||||TWO_SIDED|90.0|185.0|998.0||||||AUClast of GS-834773||998|185|
91582695|NCT02891408|183055712|OTHER||GLSM ratio|4417.0|||||TWO_SIDED|90.0|1867.0|10449.0||||||AUClast of GS-834773||10449|1867|
91582696|NCT02891408|183055712|OTHER||GLSM ratio|14676.0|||||TWO_SIDED|90.0|7932.0|27153.0||||||AUClast of GS-834773||27153|7932|
91582697|NCT02891408|183055712|OTHER||GLSM ratio|122.0|||||TWO_SIDED|90.0|86.0|173.0||||||AUClast of Fenofibric Acid||173|86|
91582698|NCT02891408|183055713|OTHER||GLSM ratio|183.0|||||TWO_SIDED|90.0|100.0|337.0||||||AUCinf of Firsocostat||337|100|
91582699|NCT02891408|183055713|OTHER||GLSM ratio|869.0|||||TWO_SIDED|90.0|482.0|1568.0||||||AUCinf of Firsocostat||1568|482|
91582700|NCT02891408|183055713|OTHER||GLSM ratio|2976.0|||||TWO_SIDED|90.0|2389.0|3708.0||||||AUCinf of Firsocostat||3708|2389|
91582701|NCT02891408|183055713|OTHER||GLSM ratio|399.0|||||TWO_SIDED|90.0|179.0|892.0||||||AUCinf of GS-834773||892|179|
91582702|NCT02891408|183055713|OTHER||GLSM ratio|3843.0|||||TWO_SIDED|90.0|1641.0|9000.0||||||AUCinf of GS-834773||9000|1641|
91582703|NCT02891408|183055713|OTHER||GLSM ratio|10712.0|||||TWO_SIDED|90.0|6525.0|17585.0||||||AUCinf of GS-834773||17585|6525|
91582704|NCT02891408|183055713|OTHER||GLSM ratio|125.0|||||TWO_SIDED|90.0|89.0|174.0||||||AUCinf of Fenofibric Acid||174|89|
91582705|NCT02891408|183055714|OTHER||GLSM ratio|169.0|||||TWO_SIDED|90.0|87.0|326.0||||||Cmax of Firsocostat||326|87|
91582706|NCT02891408|183055714|OTHER||GLSM ratio|905.0|||||TWO_SIDED|90.0|537.0|1526.0||||||Cmax of Firsocostat||1526|537|
91582707|NCT02891408|183055714|OTHER||GLSM ratio|2719.0|||||TWO_SIDED|90.0|1994.0|3708.0||||||Cmax of Firsocostat||3708|1994|
91582708|NCT02891408|183055714|OTHER||GLSM ratio|391.0|||||TWO_SIDED|90.0|163.0|942.0||||||Cmax of GS-834773||942|163|
91582709|NCT02891408|183055714|OTHER||GLSM ratio|4470.0|||||TWO_SIDED|90.0|2170.0|9207.0||||||Cmax of GS-834773||9207|2170|
91582710|NCT02891408|183055714|OTHER||GLSM ratio|9278.0|||||TWO_SIDED|90.0|4945.0|17407.0||||||Cmax of GS-834773||17407|4945|
91582711|NCT02891408|183055714|OTHER||GLSM ratio|109.0|||||TWO_SIDED|90.0|81.0|146.0||||||Cmax of Fenofibric Acid||146|81|
91582712|NCT00709852|183055725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|0.61|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91582713|NCT00709852|183055725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_DEVIATION|0.66|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
91582714|NCT00709852|183055725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.47|<|0.0001||||||for internal morphology|paired t-test|||||||< 0.0001
91582715|NCT00709852|183055726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582716|NCT00709852|183055726|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582717|NCT00709852|183055726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582718|NCT00709852|183055727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|STANDARD_DEVIATION|0.51|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582719|NCT00709852|183055727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.5|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582720|NCT00709852|183055727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.52|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582721|NCT00709852|183055728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|STANDARD_DEVIATION|0.56|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582722|NCT00709852|183055728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|0.53|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582723|NCT00709852|183055728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.42|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582724|NCT00709852|183055729|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|5.51|||TWO_SIDED|95.0|-0.199|0.984|||confidence interval for paired means|lower limit of interval is compared to noninferiority margin||BR 1||0.984|-0.199|
91582725|NCT00709852|183055729|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|12.38|||TWO_SIDED|95.0|-1.772|0.885|||confidence interval for paired means|lower limit of confidence interval (CI) is compared to noninferiority margin||BR 2||0.885|-1.772|
91582726|NCT00709852|183055729|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|4.07|||TWO_SIDED|95.0|0.125|1.0|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||BR 3||1.000|0.125|
91582727|NCT00709852|183055729|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|5.68|||TWO_SIDED|95.0|-0.439|0.78|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||AR||0.780|-0.439|
91582728|NCT00709852|183055730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582729|NCT00709852|183055730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.37|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582730|NCT00709852|183055730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.38|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582731|NCT00709852|183055731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_DEVIATION|0.62|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582732|NCT00709852|183055731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582733|NCT00709852|183055731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|0.39|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582734|NCT00709852|183055732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_DEVIATION|0.33|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582735|NCT00709852|183055732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.33|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582736|NCT00709852|183055732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582737|NCT00709852|183055733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91646476|NCT00532779|183184785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84|||<|0.001|TWO_SIDED|95.0|-8.71|-2.98|||ANCOVA|||||-2.98|-8.71|<0.001
91777476|NCT02260934|183436106|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.65||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 48|Treatment group was the independent variable in the logistic regression.|||0.65
91777477|NCT02260934|183436107|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.64||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 24 Treatment group was the independent variable in the logistic regression.||||0.64
91777478|NCT02260934|183436107|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.37||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 48||||0.37
91777479|NCT02260934|183436107|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.32|||||||Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 96||||0.32
91777480|NCT02260934|183436108|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.91||||||2 sided test|Regression, Logistic|2 sided test||Week 96||||0.91
91777481|NCT02260934|183436109|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.73||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 24||||.73
91777482|NCT02260934|183436109|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.26||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 48||||0.26
91777483|NCT02260934|183436109|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.29||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 96||||0.29
91777484|NCT02260934|183436110|SUPERIORITY|2 sided test|||||>|0.99||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 24||||>0.99
91777485|NCT02260934|183436111|SUPERIORITY|2 sided test||||||0.49||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 48||||0.49
91777486|NCT02260934|183436113|SUPERIORITY|2 sided test||||||0.89||||||2 sided test|Regression, Logistic|||Treatment group was the independent variable in the logistic regression.||||0.89
91777487|NCT02260934|183436113|SUPERIORITY|Week 48||||||0.47||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.47
91777488|NCT02260934|183436113|SUPERIORITY|Week 96||||||0.94||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.94
91777489|NCT02260934|183436114|SUPERIORITY|Week 24||||||0.08||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.08
91777490|NCT02260934|183436114|SUPERIORITY|Week 48||||||0.11||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.11
91777491|NCT02260934|183436114|SUPERIORITY|Week 96||||||0.05||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.05
91777492|NCT02260934|183436115|SUPERIORITY|Week 24||||||0.2||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||.20
91777493|NCT02260934|183436115|SUPERIORITY|Week 48|||||>|0.99||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||>0.99
91777494|NCT02260934|183436115|SUPERIORITY|Week 96||||||0.63||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.63
91777495|NCT01436526|183436118|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.35||||0.0438||90.0|101.59|115.57|||ANOVA|||||115.57|101.59|0.0438
91777496|NCT01436526|183436119|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.19||||0.0514||90.0|101.31|115.54|||ANOVA|||||115.54|101.31|0.0514
91777497|NCT01436526|183436120|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|111.64||||0.0685||90.0|101.14|123.23|||ANOVA|||||123.23|101.14|0.0685
91777498|NCT02628873|183436126|EQUIVALENCE|Degree of agreement between the 2 Assessors|Degree of agreement / Kappa|0.48|||<|0.01|TWO_SIDED||||||Kappa|||||||< 0.01
91777499|NCT02628873|183436127|SUPERIORITY|T-test to determine whether one method had greater reported pain|Mean Difference (Final Values)|-0.925|STANDARD_DEVIATION|2.71|<|0.3|TWO_SIDED|95.0|-2.69|1.0|||t-test, 2 sided|||||1.00|-2.69|< 0.30
91777500|NCT02628873|183436128|SUPERIORITY||Mean Difference (Final Values)|-0.431|STANDARD_DEVIATION|2.76|<|0.67|TWO_SIDED|95.0|-2.4|1.56|||t-test, 2 sided|Paired t-test (pre-procedure versus post-procedure)||||1.56|-2.40|< 0.67
91777501|NCT00107653|183436149|SUPERIORITY_OR_OTHER||SVR for Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08||P-values are calculated based on the difference in proportion between Latino and Non-Latino White group|Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.|SVR for Latino Versus (VS) Non-Latino White||-0.08|-0.24|<0.0001
91777502|NCT00107653|183436150|SUPERIORITY_OR_OTHER||Study Group Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.031||0.0454|TWO_SIDED|95.0|-0.12|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.00|-0.12|0.0454
91777503|NCT00107653|183436150|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.07|-0.23|0.0003
91777504|NCT00107653|183436150|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.039||0.0004|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 24||-0.06|-0.22|0.0004
91777505|NCT00107653|183436150|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 48||-0.09|-0.24|<0.0001
91777506|NCT00107653|183436150|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.25|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 60||-0.09|-0.25|<0.0001
91777507|NCT00107653|183436150|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 72||-0.08|-0.24|<0.0001
91777508|NCT00107653|183436151|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.036||0.0353|TWO_SIDED|95.0|-0.15|-0.01|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.01|-0.15|0.0353
91777509|NCT00107653|183436152|SUPERIORITY_OR_OTHER||Study Group Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.033||0.0014|TWO_SIDED|95.0|-0.17|-0.04|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.04|-0.17|0.0014
91777510|NCT00107653|183436154|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0006|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 4||-0.06|-0.22|0.0006
91777511|NCT00107653|183436154|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 12||-0.08|-0.24|<0.0001
91777512|NCT00107653|183436154|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 24||-0.07|-0.23|0.0003
91582738|NCT00709852|183055733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.23|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91646477|NCT00532779|183184786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-3.62|2.84||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.84|-3.62|
91777513|NCT00107653|183436154|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0008|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 48||-0.06|-0.22|0.0008
91777514|NCT00107653|183436154|SUPERIORITY_OR_OTHER||Study Group Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.26|-0.1|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 60||-0.10|-0.26|<0.0001
91777515|NCT00107653|183436154|SUPERIORITY_OR_OTHER||Study Group Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.27|-0.11|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 72||-0.11|-0.27|<0.0001
91582739|NCT00709852|183055733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91708351|NCT01763827|183309615|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-28.13|-12.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.69|-28.13|<0.001
91582740|NCT00709852|183055734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_DEVIATION|1.16|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582741|NCT00709852|183055734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582742|NCT00709852|183055734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.82|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582743|NCT00709852|183055735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|1.29|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582744|NCT00709852|183055735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|1.44|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582745|NCT00709852|183055735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|1.11|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582746|NCT00709852|183055736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_DEVIATION|0.95|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582747|NCT00709852|183055736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|0.97|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582748|NCT00709852|183055736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.96|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582749|NCT00709852|183055737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|1.06|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91777516|NCT00107653|183436155|SUPERIORITY_OR_OTHER||Study Group Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0285|TWO_SIDED|95.0|-0.2|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with ISHAK HAI response. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI Response For Latino VS Non-Latino White||-0.0|-0.2|0.0285
91777517|NCT00107653|183436156|SUPERIORITY_OR_OTHER||Study Group Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3|||Normal approximation to the binomial.||The estimated value is the difference in change from baseline of ISHAK HAI activity (necroinflammatory) scores between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI activity For Latino VS Non-Latino White||1.3|0.5|<0.0001
91777518|NCT00107653|183436165|SUPERIORITY_OR_OTHER||Study Group Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|95.0|-0.96|-0.33|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 48||-0.33|-0.96|<0.0001
91582750|NCT00709852|183055737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|1.07|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582751|NCT00709852|183055737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|0.83|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582752|NCT00709852|183055738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|STANDARD_DEVIATION|0.53|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
91582753|NCT00709852|183055738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.48|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582754|NCT00709852|183055738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.41|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582755|NCT00709852|183055739|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|6.44|||TWO_SIDED|95.0|-0.532|0.851|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.851|-0.532|
91582756|NCT00709852|183055740|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||||95.0|0.0004|0.078|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.078|0.0004|
91582757|NCT00709852|183055740|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.41||||95.0|-0.009|0.082|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.082|-0.009|
91582758|NCT00709852|183055740|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.29||||95.0|-0.006|0.059|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.059|-0.006|
91582759|NCT00709852|183055741|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|5.7||||95.0|-0.601|0.622|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.622|-0.601|
91582760|NCT00709852|183055742|SUPERIORITY_OR_OTHER||Difference in percentages|8.3|||||||||||||for BR1|||||
91582761|NCT00709852|183055742|SUPERIORITY_OR_OTHER||Difference in percentages|-0.9|||||||||||||for BR2|||||
91582762|NCT00709852|183055742|SUPERIORITY_OR_OTHER||Difference in percentages|15.8|||||||||||||for BR3|||||
91708352|NCT01763827|183309615|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-15.77|||<|0.001|TWO_SIDED|95.0|-24.39|-7.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.14|-24.39|<0.001
91777519|NCT00107653|183436165|SUPERIORITY_OR_OTHER||Study Group Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.156||0.0921|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 72||0.04|-0.57|0.0921
91582763|NCT00709852|183055742|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.9|||||TWO_SIDED|95.0|-0.5|18.4|||CI for paired percentages|confidence interval is given for AR; lower limit is compared to the noninferiority margin||||18.4|-0.5|
91582764|NCT00709852|183055743|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|3.6||||||95.0|-5.9|13.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||13.1|-5.9|
91646478|NCT00532779|183184786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.484|TWO_SIDED|95.0|-4.29|2.04|||ANCOVA|||||2.04|-4.29|0.484
91646479|NCT00532779|183184787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.23|||||TWO_SIDED|95.0|1.16|3.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.30|1.16|
91646480|NCT00532779|183184787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83|||||TWO_SIDED|95.0|0.76|2.9||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.90|0.76|
91646481|NCT00532779|183184788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.19|1.73||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.73|0.19|
91646482|NCT00532779|183184788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.13|1.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.67|0.13|
91708353|NCT01763827|183309616|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.27||||0.72|TWO_SIDED|95.0|-13.27|2.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.73|-13.27|0.72
91582765|NCT00709852|183055744|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.3||||||95.0|-0.9|17.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||17.6|-0.9|
91582766|NCT00709852|183055745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582767|NCT00709852|183055745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91646483|NCT00532779|183184789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.19|1.28||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.28|0.19|
91646484|NCT00532779|183184789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-0.09|1.0||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.00|-0.09|
91646485|NCT00532779|183184790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.14|1.23||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.23|0.14|
91646486|NCT00532779|183184790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.4|0.69||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.69|-0.40|
91646487|NCT00532779|183184791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.53|0.53||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.53|-0.53|
91646488|NCT00532779|183184791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.8|0.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.27|-0.80|
91646489|NCT00828516|183184846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|0.96|<|0.001||95.0||||This was not adjusted for multiple comparisons|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|There will be no improvement in MYMOP profile score after 6 acupuncture treatments.||||<0.001
91646490|NCT00828516|183184847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_DEVIATION|0.94|<|0.001||95.0||||There will be no improvement in MYMOP profile score after 12 treatments|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|||||<0.001
91646491|NCT00689273|183184848|SUPERIORITY||Least Square (LS) Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.39|TWO_SIDED|80.0|-1.23|0.24|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect. One-sided alpha of 0.1 was used for the analysis.||0.24|-1.23|0.39
91646492|NCT00689273|183184849|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.52||0.63|TWO_SIDED|80.0|-0.92|0.42|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.42|-0.92|0.63
91708354|NCT01763827|183309616|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.59|||<|0.001|TWO_SIDED|95.0|-30.98|-10.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.20|-30.98|<0.001
91582768|NCT00709852|183055746|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|3.21||||95.0|-0.053|0.636|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.636|-0.053|
91582769|NCT00709852|183055747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.64|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582770|NCT00709852|183055747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_DEVIATION|0.5|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582771|NCT00709852|183055748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582772|NCT00709852|183055748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.97|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582773|NCT00709852|183055749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_DEVIATION|0.76|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582774|NCT00709852|183055749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.63|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582775|NCT00709852|183055750|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|3.39||||95.0|-0.087|0.641|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.641|-0.087|
91582776|NCT00709852|183055751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.61|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582777|NCT00709852|183055751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_DEVIATION|0.49|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582778|NCT00709852|183055752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91582779|NCT00709852|183055752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_DEVIATION|1.01|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91582780|NCT00709852|183055753|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.06||||||95.0|0.03|0.096|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.096|0.030|
91582781|NCT00709852|183055753|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04||||||95.0|0.003|0.071|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.071|0.003|
91582782|NCT00709852|183055753|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|0.003|0.055|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.055|0.003|
91582783|NCT00709852|183055754|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.59||||95.0|-0.049|0.078|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.078|-0.049|
91582784|NCT00709852|183055755|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|-0.009|0.065|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.065|-0.009|
91582785|NCT00709852|183055755|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.01||||||95.0|-0.04|0.02|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.020|-0.040|
91582786|NCT00709852|183055755|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01||||||95.0|-0.015|0.035|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.035|-0.015|
91582787|NCT00709852|183055756|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.042|0.153|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.153|0.042|
91582788|NCT00709852|183055756|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.03|0.161|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.161|0.030|
91582789|NCT00709852|183055756|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.05||||||95.0|0.006|0.098|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.098|0.006|
91582790|NCT00709852|183055757|SUPERIORITY_OR_OTHER||Difference|6.2||||0.0082|||||||McNemar|||||||0.0082
91582791|NCT00709852|183055758|SUPERIORITY_OR_OTHER||Difference|9.9|||<|0.0001|||||||McNemar|||||||< 0.0001
91582792|NCT00709852|183055759|SUPERIORITY_OR_OTHER||Difference|6.8||||0.0039|||||||McNemar|||||||0.0039
91582793|NCT00709852|183055760|SUPERIORITY_OR_OTHER||Difference|9.2|||<|0.0001|||||||McNemar|||||||< 0.0001
91582794|NCT00709852|183055761|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-0.4||||||95.0|-3.8|2.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||2.9|-3.8|
91582795|NCT00709852|183055762|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of interval is compared to noninferiority margin||||1.6|-0.3|
91582796|NCT00709852|183055763|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
91582797|NCT00709852|183055764|SUPERIORITY_OR_OTHER||Difference|13.6|||<|0.0001|||||||McNemar|||||||< 0.0001
91582798|NCT00709852|183055765|SUPERIORITY_OR_OTHER||Difference|0.0||||1|||||||McNemar|||||||1.0000
91582799|NCT00709852|183055766|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
91582800|NCT00709852|183055767|SUPERIORITY_OR_OTHER||Difference|13.1||||0.0001|||||||McNemar|||||||0.0001
91582801|NCT00709852|183055768|SUPERIORITY_OR_OTHER||Difference|1.6||||0.763|||||||McNemar|||||||0.7630
91582802|NCT00709852|183055769|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-3.1|3.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.1|-3.1|
91582803|NCT00709852|183055770|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-2.7|3.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.6|-2.7|
91582804|NCT00709852|183055771|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-1.6||||||95.0|-10.1|6.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||6.9|-10.1|
91582805|NCT00709852|183055772|SUPERIORITY_OR_OTHER||Difference|6.5||||0.0006|||||||McNemar|||||||0.0006
91582806|NCT00709852|183055773|SUPERIORITY_OR_OTHER||Difference|19.4||||0.0004|||||||McNemar|||||||0.0004
91582807|NCT00709852|183055774|SUPERIORITY_OR_OTHER||Difference|0.5||||0.6547|||||||McNemar|||||||0.6547
91582808|NCT00709852|183055775|SUPERIORITY_OR_OTHER||Difference|7.9|||<|0.0001|||||||McNemar|||||||< 0.0001
91582809|NCT00709852|183055776|SUPERIORITY_OR_OTHER||Difference|21.5|||<|0.0001|||||||McNemar|||||||< 0.0001
91582810|NCT00709852|183055777|SUPERIORITY_OR_OTHER||Difference|1.5||||0.0833|||||||McNemar|||||||0.0833
91582811|NCT00709852|183055778|SUPERIORITY_OR_OTHER||Difference|4.5||||0.0236|||||||McNemar|||||||0.0236
91582812|NCT00709852|183055779|SUPERIORITY_OR_OTHER||Difference|12.9||||0.0186|||||||McNemar|||||||0.0186
91582813|NCT00709852|183055780|SUPERIORITY_OR_OTHER||Difference|0.5||||0.7055|||||||McNemar|||||||0.7055
91582814|NCT00709852|183055781|SUPERIORITY_OR_OTHER||Difference|7.2|||<|0.0001|||||||McNemar|||||||< 0.0001
91582815|NCT00709852|183055782|SUPERIORITY_OR_OTHER||Difference|20.4|||<|0.0001|||||||McNemar|||||||< 0.0001
91582816|NCT00709852|183055783|SUPERIORITY_OR_OTHER||Difference|1.0||||0.1573|||||||McNemar|||||||0.1573
91708355|NCT01763827|183309616|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.71||||0.027|TWO_SIDED|95.0|-16.86|1.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.45|-16.86|0.027
91582817|NCT00709852|183055784|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|2.1||||||95.0|0.2|3.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.9|0.2|
91582818|NCT00709852|183055785|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|6.5||||||95.0|1.5|11.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||11.4|1.5|
91582819|NCT00709852|183055786|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-1.4|1.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.4|-1.4|
91582820|NCT00709852|183055787|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.6|-0.3|
91582821|NCT00709852|183055788|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|1.1||||||95.0|-1.0|3.2|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.2|-1.0|
91582822|NCT00709852|183055789|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-0.5|1.5|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.5|-0.5|
91582823|NCT00709852|183055790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.56|<|0.0001|||||||paired t test|||||||< 0.0001
91582824|NCT00709852|183055791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.58|<|0.0001|||||||paired t test|||||||< 0.0001
91582825|NCT00709852|183055792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.48||||||||||||||||
91582826|NCT00709852|183055793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.93|<|0.0001|||||||paired t test|||||||< 0.0001
91582827|NCT00709852|183055794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|0.89|<|0.0001|||||||paired t test|||||||< 0.0001
91582828|NCT00709852|183055795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.39||||||||||||||||
91582829|NCT00709852|183055796|SUPERIORITY_OR_OTHER||||||<|0.0001||||||for all three readers|t-test, 2 sided|||||||< 0.0001
91582830|NCT00709852|183055798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|1.06||||||||||||||||
91582831|NCT00709852|183055799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|26.6||||||||||||||||
91582832|NCT05249829|183055800|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
91582833|NCT05249829|183055801|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||2.010|1.546|
91708356|NCT01763827|183309616|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-11.73||||0.044|TWO_SIDED|95.0|-21.19|-2.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-2.27|-21.19|0.044
91777520|NCT00107653|183436165|SUPERIORITY_OR_OTHER||Study Group Difference|-8.72|STANDARD_ERROR_OF_MEAN|2.725||0.0015|TWO_SIDED|95.0|-14.07|-3.36|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 48 between Latino and Non-Latino White participants The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 48||-3.36|-14.07|0.0015
91777521|NCT00107653|183436165|SUPERIORITY_OR_OTHER||Study Group Difference|4.83|STANDARD_ERROR_OF_MEAN|2.37||0.0421|TWO_SIDED|95.0|0.18|9.49|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 72||9.49|0.18|0.0421
91777522|NCT00107653|183436166|SUPERIORITY_OR_OTHER||Study Group Difference|3.49|STANDARD_ERROR_OF_MEAN|0.864|<|0.0001|TWO_SIDED|95.0|1.79|5.18|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 48||5.18|1.79|<0.0001
91777523|NCT00107653|183436166|SUPERIORITY_OR_OTHER||Study Group Difference|0.1|STANDARD_ERROR_OF_MEAN|0.808||0.9047|TWO_SIDED|95.0|-1.49|1.68|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 72||1.68|-1.49|0.9047
91777524|NCT00107653|183436166|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.914||0.9286|TWO_SIDED|95.0|-1.88|1.71|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 48||1.71|-1.88|0.9286
91777525|NCT00107653|183436166|SUPERIORITY_OR_OTHER||Study Group Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1653|TWO_SIDED|95.0|-2.98|0.51|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 72||0.51|-2.98|0.1653
91777526|NCT02234843|183436215|OTHER||Hazard Ratio (HR)|0.4||||0.1509|TWO_SIDED|95.0|0.11|1.41|||Expl. Cox Proportional Hazards Model|||||1.41|0.11|0.1509
91777527|NCT04272242|183436257|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.91|0.93|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmax, comparing Day 28 to Day 0.||0.93|0.91|
91777528|NCT04272242|183436258|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.96|0.96|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for AUC0-24, comparing Day 28 to Day 0.||0.96|0.96|
91777529|NCT04272242|183436259|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmin, comparing Day 28 to Day 0.||1.00|0.97|
91777530|NCT00091949|183436277|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.0067|TWO_SIDED|95.0|0.62|0.93||P-value adjusted for interim looks.|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for interim looks.|||0.93|0.62|.0067
91777531|NCT00091949|183436278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.19|TWO_SIDED|95.0|0.61|1.1||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; conference interval (CI) adjusted for multiplicity (5 secondary outcomes).|||1.1|0.61|0.19
91777532|NCT00091949|183436279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.11|TWO_SIDED|95.0|0.52|1.07||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.07|0.52|0.11
91777533|NCT00091949|183436281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.52|TWO_SIDED|95.0|0.73|1.17||p-value adjusted for multiplicity (5 secondary outcomes)|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.17|0.73|0.52
91777534|NCT00091949|183436282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.023||||0.88|TWO_SIDED|95.0|-0.326|0.28|||Mixed Models Analysis||Pioglitazone arm compared to placebo.|Changes in modified mini-mental examination (3MS) score from baseline (to annual scores) were analyzed using a longitudinal repeated measures mixed effects model.||0.280|-0.326|0.88
91777535|NCT00091949|183436283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.11|TWO_SIDED|95.0|0.65|1.05||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.05|0.65|0.11
91777536|NCT05966142|183436293|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.5913|TWO_SIDED|95.0|-0.42|0.74|||t-test, 2 sided|||||0.74|-0.42|0.5913
91777537|NCT05966142|183436294|SUPERIORITY|||||||0.6803|||||||t-test, 2 sided|||||||0.6803
91777538|NCT05966142|183436295|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
91777539|NCT05966142|183436296|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.5252|TWO_SIDED|95.0|-1.7|0.9|||t-test, 2 sided|||||0.9|-1.7|0.5252
91582834|NCT05249829|183055802|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.535|||||TWO_SIDED|99.0|1.409|1.672||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||1.672|1.409|
91582835|NCT05249829|183055803|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.713|||||TWO_SIDED|96.0|1.583|1.853||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||1.853|1.583|
91582836|NCT05249829|183055804|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.048|||||TWO_SIDED|99.0|0.958|1.147||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 29 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1818).||1.147|0.958|
91582837|NCT05249829|183055805|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.104|||||TWO_SIDED|96.0|1.032|1.18||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1418).||1.180|1.032|
91582838|NCT05249829|183055812|SUPERIORITY|Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
91582839|NCT05249829|183055812|SUPERIORITY|Superiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=460).||2.010|1.546|
91582840|NCT02842827|183055875|OTHER|||||||0.3868|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.3868
91582841|NCT02842827|183055876|OTHER|||||||0.7744|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.7744
91582842|NCT02842827|183055877|OTHER|||||||0.508|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.5080
91582843|NCT02842827|183055878|OTHER|||||||0.6109|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.6109
91582844|NCT02842827|183055879|OTHER|||||||0.1151|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.1151
91582845|NCT02842827|183055880|OTHER|||||||0.0791|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.0791
91582846|NCT01815138|183055882|OTHER||Odds Ratio (OR)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
91582847|NCT01815138|183055883|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91582848|NCT00825825|183055885|SUPERIORITY_OR_OTHER|||||||0.000704||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.000704
91582849|NCT00825825|183055886|SUPERIORITY_OR_OTHER|||||||1.62e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0000162
91582850|NCT00825825|183055887|SUPERIORITY_OR_OTHER|||||||9.36e-06||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.00000936
91582851|NCT00825825|183055888|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.0279
91582852|NCT00825825|183055889|SUPERIORITY_OR_OTHER|||||||0.00124||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and placebo medication periods.||||0.00124
91582853|NCT00825825|183055890|SUPERIORITY_OR_OTHER|||||||6.33e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the placebo and citalopram medication periods.||||0.0000633
91582854|NCT00825825|183055891|SUPERIORITY_OR_OTHER|||||||0.0241||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0241
91582855|NCT00882687|183055892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3235|||||||Wilcoxon rank-sum test|||||||0.3235
91582856|NCT00882687|183055892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9144|||||||Wilcoxon rank-sum test|||||||0.9144
91582857|NCT00882687|183055892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3324|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.3324
91582858|NCT00882687|183055893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5846|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.5846
91582859|NCT00882687|183055893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1493
91777540|NCT05966142|183436297|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
91777541|NCT00894803|183436306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|an exact logistic regression was used due to the number of events|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
91777542|NCT00894803|183436307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.23|TWO_SIDED|95.0|0.7|4.31|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.31|0.70|0.23
91777543|NCT00894803|183436307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.53|TWO_SIDED|95.0|0.51|3.71|||Regression, Logistic|adjusting for age, baseline NIHSS score and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.71|0.51|0.53
91777544|NCT00894803|183436309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
91777545|NCT00894803|183436310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.76||95.0|0.35|8.02|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||8.02|0.35|0.76
91777546|NCT00894803|183436311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to small number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
91777547|NCT00894803|183436312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
91777548|NCT00894803|183436313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.78|TWO_SIDED|95.0|0.38|5.76|||Regression, Logistic|Exact methods used due t number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.76|0.38|0.78
91777549|NCT00894803|183436314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.99999|TWO_SIDED|95.0|0.26|4.18|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.18|0.26|0.99999
91777550|NCT00894803|183436315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.35|TWO_SIDED|95.0|0.63|3.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.67|0.63|0.35
91777551|NCT00894803|183436315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|3.02|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.02|0.40|0.85
91777552|NCT00894803|183436316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.3|TWO_SIDED|95.0|0.65|3.88|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.88|0.65|0.30
91777553|NCT00894803|183436316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.24|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.24|0.44|0.73
91777554|NCT00894803|183436317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.61|4.99|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.99|0.61|0.31
91777555|NCT00894803|183436318|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.55|TWO_SIDED|95.0|0.47|4.07|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.07|0.47|0.55
91777556|NCT00894803|183436319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.46|2.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||2.67|0.46|0.82
91777557|NCT00894803|183436320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.07|TWO_SIDED|95.0|0.9|6.64|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||6.64|0.90|0.07
91777558|NCT00894803|183436320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.22|TWO_SIDED|95.0|0.67|5.88|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.88|0.67|0.22
91777559|NCT00449696|183436322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.91||||0.122||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.122
91777560|NCT00449696|183436323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42||||0.071||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.071
91777561|NCT00449696|183436324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.64||||0.058||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.058
91777562|NCT00449696|183436325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.022||95.0||||P-value for strict OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.022
91777563|NCT00449696|183436325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.242||95.0||||P-value for OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.242
91777564|NCT00449696|183436326|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||P-value for physical component scores, physical function subscale, role physical subscale, and bodily pain subscale.|Wilcoxon (Mann-Whitney)|||||||>0.05
91777565|NCT00449696|183436327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.39||||0.037||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.037
91777566|NCT00449696|183436328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.746||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.746
91582860|NCT00882687|183055893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0404|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0404
91582861|NCT00882687|183055894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0578|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0578
91582862|NCT00882687|183055894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8988|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.8988
91582863|NCT00882687|183055894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4709
91582864|NCT00882687|183055895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1773|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1773
91582865|NCT00882687|183055895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4222|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4222
91582866|NCT00882687|183055895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4326|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4326
91582867|NCT02649946|183055899|SUPERIORITY|TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.|||||<|0.001||||||Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.|Chi-squared|||"Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.~Sample size calculation: 238 randomized subjects \[214 evaluable\] will give 92% power with one-sided type 1 error = 0.025."||||<0.001
91582868|NCT02649946|183055900|NON_INFERIORITY|Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.||||||0.0022|||||||Farrington and Manning|Non-inferiority test with non-inferiority margin of 10%.||"Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.~Sample size: 238 randomized subjects \[226 evaluable\] will give 85% power with one-sided type 1 error = 0.025."||||0.0022
91582869|NCT01588496|183056013|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.78|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-40.94|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-18.62|-40.94|<0.001
91582870|NCT01588496|183056014|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-23.14|STANDARD_ERROR_OF_MEAN|5.81|<|0.001|TWO_SIDED|95.0|-34.83|-11.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-11.45|-34.83|<0.001
91582871|NCT01588496|183056015|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.89|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-33.72|-12.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-12.05|-33.72|<0.001
91777567|NCT00449696|183436329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.166||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.166
91777568|NCT00449696|183436330|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.041
91582872|NCT01588496|183056016|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.83|STANDARD_ERROR_OF_MEAN|6.77||0.088|TWO_SIDED|95.0|-25.48|1.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||1.82|-25.48|0.088
91582873|NCT01588496|183056017|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.27|STANDARD_ERROR_OF_MEAN|5.86||0.088|TWO_SIDED|95.0|-23.11|0.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||0.56|-23.11|0.088
91582874|NCT01588496|183056018|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-30.93|STANDARD_ERROR_OF_MEAN|6.42|<|0.001|TWO_SIDED|95.0|-43.86|-18.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.||-18.00|-43.86|<0.001
91582875|NCT03143166|183056019|OTHER||Adjusted gMean ratio Test/Reference (%)|28.85|STANDARD_ERROR_OF_MEAN|86.7|||TWO_SIDED|90.0|21.346|38.996|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||38.996|21.346|
91582876|NCT03143166|183056020|OTHER||Adjusted gMean ratio Test/Reference (%)|26.37|STANDARD_ERROR_OF_MEAN|76.6|||TWO_SIDED|90.0|20.066|34.665|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||34.665|20.066|
91777569|NCT00307801|183436333|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
91777570|NCT03431259|183436387|SUPERIORITY|||||||0.0574|||||||Chi-squared|||||||.0574
91777571|NCT03431259|183436387|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.570
91777572|NCT03994081|183436413|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||||||0.332
91777573|NCT03994081|183436414|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.790
91777574|NCT03994081|183436415|SUPERIORITY|||||||0.464|||||||Pearson's correlation|||||||0.464
91582877|NCT03143166|183056021|OTHER||Adjusted gMean ratio Test/Reference (%)|28.02|STANDARD_ERROR_OF_MEAN|83.4|||TWO_SIDED|90.0|20.914|37.537|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||37.537|20.914|
91582878|NCT03143166|183056022|OTHER||Adjusted gMean ratio Test/Reference (%)|27.56|STANDARD_ERROR_OF_MEAN|75.6|||TWO_SIDED|90.0|21.023|36.118|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||36.118|21.023|
91582879|NCT03143166|183056023|OTHER||Adjusted gMean ratio Test/Reference (%)|30.59|STANDARD_ERROR_OF_MEAN|76.8|||TWO_SIDED|90.0|23.26|40.234|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.234|23.260|
91582880|NCT03143166|183056024|OTHER||Adjusted gMean ratio Test/Reference (%)|30.61|STANDARD_ERROR_OF_MEAN|74.9|||TWO_SIDED|90.0|23.404|40.037|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.037|23.404|
91582881|NCT04619251|183056028|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|337.6|||||TWO_SIDED|90.0|302.8|376.4|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =15.9|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||376.4|302.8|
91582882|NCT04619251|183056029|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|184.4|||||TWO_SIDED|90.0|156.0|218.0|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =26.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||218.0|156.0|
91582883|NCT04619251|183056030|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|356.8|||||TWO_SIDED|90.0|315.7|403.2|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =18.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||403.2|315.7|
91777575|NCT03994081|183436415|SUPERIORITY|||||||0.765|||||||Pearson's correlation|||||||0.765
91777576|NCT03994081|183436416|SUPERIORITY|||||||0.072|||||||Pearson's correlation|||||||0.072
91777577|NCT03994081|183436416|SUPERIORITY|||||||0.811|||||||Pearson's correlation|||||||0.811
91777578|NCT02059278|183436450|EQUIVALENCE|Analysis at 8 am on Day 15|Mean Difference (Final Values)|0.781||||0.0091|TWO_SIDED|95.0|0.195|1.366|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.366|0.195|0.0091
91777579|NCT02059278|183436450|EQUIVALENCE|Analysis at 10 am on Day 15|Mean Difference (Final Values)|0.664||||0.0098|TWO_SIDED|95.0|0.161|1.167|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.167|0.161|0.0098
91777580|NCT02059278|183436450|EQUIVALENCE|Analysis at 4 pm on Day 15|Mean Difference (Final Values)|0.542||||0.0398|TWO_SIDED|95.0|0.025|1.058|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.058|0.025|0.0398
91777581|NCT02059278|183436450|EQUIVALENCE|Analysis at 8 am on Day 42|Mean Difference (Final Values)|0.478||||0.1008|TWO_SIDED|95.0|-0.093|1.05|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.050|-0.093|0.1008
91582884|NCT00803751|183056040|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Fisher Exact|||||||0.17
91582885|NCT00803751|183056041|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Fisher Exact|||||||0.45
91582886|NCT00803751|183056042|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
91582887|NCT00803751|183056043|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
91582888|NCT00803751|183056044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91582889|NCT00803751|183056045|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||||||0.0004
91646493|NCT00689273|183184850|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.27||0.54|TWO_SIDED|80.0|-0.51|0.18|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.18|-0.51|0.54
91582890|NCT03102645|183056046|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.07|TWO_SIDED|95.0|-0.5|13.5|||t-test, 2 sided|CROS. DF=14.||CROS test||13.5|-0.5|0.07
91582891|NCT03102645|183056047|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.03|TWO_SIDED|95.0|2.0|28.2|||t-test, 2 sided|CROS test||CROS test||28.2|2.0|0.03
91582892|NCT01413087|183056048|SUPERIORITY|||||||0.483|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.483
91582893|NCT01413087|183056049|SUPERIORITY|||||||0.992|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.992
91582894|NCT05026710|183056068|SUPERIORITY|||||||0.26|||||||Regression, Linear|||||||0.26
91582895|NCT05026710|183056069|SUPERIORITY|||||||0.57|||||||Regression, Linear|||||||0.57
91582896|NCT05026710|183056070|SUPERIORITY|||||||0.58|||||||Regression, Linear|||||||0.58
91582897|NCT05026710|183056071|SUPERIORITY|||||||0.72|||||||Regression, Linear|||||||0.72
91646494|NCT00689273|183184850|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|80.0|-0.51|0.21|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.21|-0.51|0.60
91582898|NCT05026710|183056072|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
91582899|NCT05026710|183056073|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Linear mixed effects; covariates: days since URS, study arm, days\*arm, baseline LURN, stone location; random intercept with unstructured covariance||||||0.80
91582900|NCT05026710|183056074|SUPERIORITY|||||||0.25|||||||WinRatio, unmatched unstratified|WinRatio using unmatched method.||||||0.25
91582901|NCT05026710|183056075|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
91582902|NCT05026710|183056076|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||0.85
91582903|NCT01981473|183056119|SUPERIORITY_OR_OTHER||||||<|0.0001||||||As there was only one primary endpoint, no adjustment was made for multiple comparisons.|Fisher Exact|Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher's exact test was used.||This sample was to provide \>95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.||||<0.0001
91582904|NCT03405792|183056160|OTHER|||||||||||||||||We will use one-sample log-rank test to compare PFS between the triple combination arm relative to the historical control arm.|We took a look at median survival time and CI of our population and we compared it to the median PFS and CI of the historical control descriptively. There is no yielded P value.|||
91582905|NCT03405792|183056161|OTHER||||||||||||||||||Every participant (26/26; 100%) experienced an adverse event.|||
91582906|NCT03486457|183056190|SUPERIORITY||Difference in percentage of participants|32.35|STANDARD_ERROR_OF_MEAN|5.05|<|0.0001|TWO_SIDED|95.0|22.45|42.25|||Normal approximation|||The normal approximation to the difference in binomial proportions was used to test the difference between tofacitinib 5 mg BID and placebo and to generate 95% CI and p-value for the difference in response rates.||42.25|22.45|<0.0001
91646495|NCT00689273|183184851|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|1.8||0.44|TWO_SIDED|80.0|-3.69|0.94|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.94|-3.69|0.44
91708357|NCT01763827|183309617|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-6.23||||0.72|TWO_SIDED|95.0|-16.41|3.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||3.95|-16.41|0.72
91582907|NCT03486457|183056191|SUPERIORITY||Difference in percentage of participants|15.44|STANDARD_ERROR_OF_MEAN|4.79||0.0013|TWO_SIDED|95.0|6.05|24.83|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.83|6.05|0.0013
91582908|NCT03486457|183056191|SUPERIORITY||Difference in percentage of participants|30.15|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|19.53|40.76|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.76|19.53|<0.0001
91582909|NCT03486457|183056191|SUPERIORITY||Difference in percentage of participants|51.47|STANDARD_ERROR_OF_MEAN|5.56|<|0.0001|TWO_SIDED|95.0|40.57|62.37|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||62.37|40.57|<0.0001
91582910|NCT03486457|183056191|SUPERIORITY||Difference in percentage of participants|36.76|STANDARD_ERROR_OF_MEAN|6.81|<|0.0001|TWO_SIDED|95.0|23.41|50.12|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||50.12|23.41|<0.0001
91582911|NCT03486457|183056191|SUPERIORITY||Difference in percentage of participants|24.26|STANDARD_ERROR_OF_MEAN|7.21||0.0008|TWO_SIDED|95.0|10.14|38.39|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||38.39|10.14|0.0008
91582912|NCT03486457|183056191|SUPERIORITY||Difference in percentage of participants|13.97|STANDARD_ERROR_OF_MEAN|7.08||0.0486|TWO_SIDED|95.0|0.09|27.85|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||27.85|0.09|0.0486
91582913|NCT03486457|183056192|SUPERIORITY||Difference in percentage of participants|1.1|STANDARD_ERROR_OF_MEAN|1.53||0.473|TWO_SIDED|95.0|-1.9|4.1|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||4.10|-1.90|0.4730
91582914|NCT03486457|183056192|SUPERIORITY||Difference in percentage of participants|1.83|STANDARD_ERROR_OF_MEAN|1.69||0.2792|TWO_SIDED|95.0|-1.48|5.14|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||5.14|-1.48|0.2792
91582915|NCT03486457|183056192|SUPERIORITY||Difference in percentage of participants|7.35|STANDARD_ERROR_OF_MEAN|2.84||0.0095|TWO_SIDED|95.0|1.79|12.91|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||12.91|1.79|0.0095
91582916|NCT03486457|183056192|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|6.63|19.84|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||19.84|6.63|<0.0001
91582917|NCT03486457|183056192|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|4.69||0.0048|TWO_SIDED|95.0|4.03|22.44|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.44|4.03|0.0048
91582918|NCT03486457|183056192|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|6.6||0.0449|TWO_SIDED|95.0|0.3|26.17|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.17|0.30|0.0449
91582919|NCT03486457|183056193|SUPERIORITY||Difference in percentage of participants|2.94|STANDARD_ERROR_OF_MEAN|2.29||0.1985|TWO_SIDED|95.0|-1.54|7.42|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||7.42|-1.54|0.1985
91582920|NCT03486457|183056193|SUPERIORITY||Difference in percentage of participants|8.09|STANDARD_ERROR_OF_MEAN|2.91||0.0055|TWO_SIDED|95.0|2.38|13.8|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||13.80|2.38|0.0055
91646496|NCT00689273|183184851|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.0||0.23|TWO_SIDED|80.0|-5.0|0.16|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-5.00|0.23
91708358|NCT01763827|183309617|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.65|||<|0.001|TWO_SIDED|95.0|-26.67|-8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm|||-8.63|-26.67|<0.001
91582921|NCT03486457|183056193|SUPERIORITY||Difference in percentage of participants|27.21|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|18.51|35.9|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||35.90|18.51|<0.0001
91582922|NCT03486457|183056193|SUPERIORITY||Difference in percentage of participants|22.06|STANDARD_ERROR_OF_MEAN|6.37||0.0005|TWO_SIDED|95.0|9.58|34.54|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||34.54|9.58|0.0005
91582923|NCT03486457|183056193|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.24||0.0111|TWO_SIDED|95.0|4.2|32.57|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.57|4.20|0.0111
91582924|NCT03486457|183056194|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0097|TWO_SIDED|95.0|-0.2|-0.03|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.03|-0.20|0.0097
91582925|NCT03486457|183056194|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.045||0.0043|TWO_SIDED|95.0|-0.22|-0.04|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.04|-0.22|0.0043
91582926|NCT03486457|183056194|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.3|-0.11|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.30|<0.0001
91582927|NCT03486457|183056194|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001|TWO_SIDED|95.0|-0.32|-0.11|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.32|<0.0001
91646497|NCT00689273|183184852|SUPERIORITY||LS Mean Difference|-1.76|STANDARD_ERROR_OF_MEAN|2.46||0.48|TWO_SIDED|80.0|-4.94|1.41|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||1.41|-4.94|0.48
91582928|NCT03486457|183056194|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0535|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.18|0.0535
91582929|NCT03486457|183056194|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.094|TWO_SIDED|95.0|-0.16|0.01|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.16|0.0940
91582930|NCT03486457|183056195|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
91582931|NCT03486457|183056195|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
91582932|NCT03486457|183056195|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
91582933|NCT03486457|183056195|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
91582934|NCT03486457|183056195|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
91582935|NCT03486457|183056195|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
91582936|NCT03486457|183056196|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
91646498|NCT00689273|183184852|SUPERIORITY||LS Mean Difference|-3.02|STANDARD_ERROR_OF_MEAN|2.79||0.28|TWO_SIDED|80.0|-6.61|0.57|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.57|-6.61|0.28
91646499|NCT00689273|183184853|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.91||0.48|TWO_SIDED|80.0|-1.81|0.52|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.52|-1.81|0.48
91582937|NCT03486457|183056196|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
91582938|NCT03486457|183056196|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
91582939|NCT03486457|183056196|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
91582940|NCT03486457|183056196|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
91582941|NCT03486457|183056196|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
91582942|NCT03486457|183056197|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.633|<|0.0001|TWO_SIDED|95.0|-3.95|-1.45|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.45|-3.95|<0.0001
91582943|NCT03486457|183056197|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.2|-2.39|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.39|-5.20|<0.0001
91582944|NCT03486457|183056197|SUPERIORITY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|-6.39|-3.39|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.39|-6.39|<0.0001
91582945|NCT03486457|183056197|SUPERIORITY||LS mean difference|-5.85|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.53|-4.17|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.17|-7.53|<0.0001
91582946|NCT03486457|183056197|SUPERIORITY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.583|<|0.0001|TWO_SIDED|95.0|-4.35|-2.04|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.04|-4.35|<0.0001
91582947|NCT03486457|183056197|SUPERIORITY||LS mean difference|-2.59|STANDARD_ERROR_OF_MEAN|0.668||0.0002|TWO_SIDED|95.0|-3.91|-1.27|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.27|-3.91|0.0002
91582948|NCT03486457|183056198|SUPERIORITY||LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.012||0.001|TWO_SIDED|95.0|-5.4|-1.4|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.40|-5.40|0.0010
91582949|NCT03486457|183056198|SUPERIORITY||LS mean difference|-5.03|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-7.05|-3.01|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.01|-7.05|<0.0001
91582950|NCT03486457|183056198|SUPERIORITY||LS mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-7.7|-3.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.66|-7.70|<0.0001
91582951|NCT03486457|183056198|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|1.111|<|0.0001|TWO_SIDED|95.0|-9.2|-4.82|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.82|-9.20|<0.0001
91582952|NCT03486457|183056198|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.073||0.0003|TWO_SIDED|95.0|-6.07|-1.83|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.83|-6.07|0.0003
91582953|NCT03486457|183056198|SUPERIORITY||LS mean difference|-2.39|STANDARD_ERROR_OF_MEAN|1.108||0.0323|TWO_SIDED|95.0|-4.58|-0.2|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.20|-4.58|0.0323
91582954|NCT03486457|183056199|SUPERIORITY||LS mean difference|-6.57|STANDARD_ERROR_OF_MEAN|2.481||0.0087|TWO_SIDED|95.0|-11.46|-1.68|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.68|-11.46|0.0087
91582955|NCT03486457|183056199|SUPERIORITY||LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|2.487|<|0.0001|TWO_SIDED|95.0|-16.6|-6.79|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.79|-16.60|<0.0001
91646500|NCT00689273|183184853|SUPERIORITY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|1.03||0.28|TWO_SIDED|80.0|-2.45|0.2|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.20|-2.45|0.28
91582956|NCT03486457|183056199|SUPERIORITY||LS mean difference|-16.14|STANDARD_ERROR_OF_MEAN|2.796|<|0.0001|TWO_SIDED|95.0|-21.66|-10.63|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.63|-21.66|<0.0001
91582957|NCT03486457|183056199|SUPERIORITY||LS mean difference|-21.87|STANDARD_ERROR_OF_MEAN|3.027|<|0.0001|TWO_SIDED|95.0|-27.84|-15.9|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.90|-27.84|<0.0001
91582958|NCT03486457|183056199|SUPERIORITY||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.865||0.0163|TWO_SIDED|95.0|-12.6|-1.29|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.29|-12.60|0.0163
91582959|NCT03486457|183056199|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.967||0.2977|TWO_SIDED|95.0|-8.95|2.76|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.76|-8.95|0.2977
91582960|NCT03486457|183056200|SUPERIORITY||LS mean difference|-6.15|STANDARD_ERROR_OF_MEAN|2.646||0.0211|TWO_SIDED|95.0|-11.37|-0.93|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.93|-11.37|0.0211
91582961|NCT03486457|183056200|SUPERIORITY||LS mean difference|-13.08|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|95.0|-18.59|-7.58|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.58|-18.59|<0.0001
91582962|NCT03486457|183056200|SUPERIORITY||LS mean difference|-13.16|STANDARD_ERROR_OF_MEAN|2.928|<|0.0001|TWO_SIDED|95.0|-18.93|-7.38|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.38|-18.93|<0.0001
91582963|NCT03486457|183056200|SUPERIORITY||LS mean difference|-18.77|STANDARD_ERROR_OF_MEAN|3.187|<|0.0001|TWO_SIDED|95.0|-25.06|-12.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.49|-25.06|<0.0001
91582964|NCT03486457|183056200|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|2.827||0.014|TWO_SIDED|95.0|-12.59|-1.43|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.43|-12.59|0.0140
91582965|NCT03486457|183056200|SUPERIORITY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.931||0.0811|TWO_SIDED|95.0|-10.93|0.64|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.64|-10.93|0.0811
91582966|NCT03486457|183056201|SUPERIORITY||LS mean difference|-9.64|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|-13.46|-5.81|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.81|-13.46|<0.0001
91582967|NCT03486457|183056201|SUPERIORITY||LS mean difference|-9.52|STANDARD_ERROR_OF_MEAN|2.305|<|0.0001|TWO_SIDED|95.0|-14.07|-4.98|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.98|-14.07|<0.0001
91582968|NCT03486457|183056201|SUPERIORITY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|2.472|<|0.0001|TWO_SIDED|95.0|-21.85|-12.1|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.10|-21.85|<0.0001
91582969|NCT03486457|183056201|SUPERIORITY||LS mean difference|-18.42|STANDARD_ERROR_OF_MEAN|2.506|<|0.0001|TWO_SIDED|95.0|-23.36|-13.48|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-13.48|-23.36|<0.0001
91582970|NCT03486457|183056201|SUPERIORITY||LS mean difference|-7.22|STANDARD_ERROR_OF_MEAN|2.453||0.0037|TWO_SIDED|95.0|-12.06|-2.38|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.38|-12.06|0.0037
91582971|NCT03486457|183056201|SUPERIORITY||LS mean difference|-7.66|STANDARD_ERROR_OF_MEAN|2.267||0.0009|TWO_SIDED|95.0|-12.13|-3.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.18|-12.13|0.0009
91582972|NCT03486457|183056202|SUPERIORITY||LS mean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|-9.39|-5.02|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.02|-9.39|<0.0001
91582973|NCT03486457|183056202|SUPERIORITY||LS mean difference|-7.87|STANDARD_ERROR_OF_MEAN|1.171|<|0.0001|TWO_SIDED|95.0|-10.18|-5.56|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.56|-10.18|<0.0001
91582974|NCT03486457|183056202|SUPERIORITY||LS mean difference|-7.41|STANDARD_ERROR_OF_MEAN|1.182|<|0.0001|TWO_SIDED|95.0|-9.74|-5.08|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.08|-9.74|<0.0001
91582975|NCT03486457|183056202|SUPERIORITY||LS mean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.221|<|0.0001|TWO_SIDED|95.0|-10.21|-5.39|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.39|-10.21|<0.0001
91582976|NCT03486457|183056202|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.615||0.6264|TWO_SIDED|95.0|-0.91|1.51|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||1.51|-0.91|0.6264
91582977|NCT03486457|183056202|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.778||0.1008|TWO_SIDED|95.0|-2.82|0.25|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-2.82|0.1008
91582978|NCT03486457|183056203|SUPERIORITY||Difference in percentage of participants|0.44|STANDARD_ERROR_OF_MEAN|1.77||0.8032|TWO_SIDED|95.0|-3.02|3.9|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.90|-3.02|0.8032
91582979|NCT03486457|183056203|SUPERIORITY||Difference in percentage of participants|7.47|STANDARD_ERROR_OF_MEAN|3.44||0.0298|TWO_SIDED|95.0|0.73|14.21|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||14.21|0.73|0.0298
91582980|NCT03486457|183056203|SUPERIORITY||Difference in percentage of participants|-11.19|STANDARD_ERROR_OF_MEAN|6.48||0.084|TWO_SIDED|95.0|-23.88|1.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||1.50|-23.88|0.0840
91582981|NCT03486457|183056204|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.111||0.002|TWO_SIDED|95.0|-0.57|-0.13|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.57|0.0020
91582982|NCT03486457|183056204|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.32|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.32|-0.87|<0.0001
91582983|NCT03486457|183056204|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9678|TWO_SIDED|95.0|-0.3|0.31|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.31|-0.30|0.9678
91582984|NCT03486457|183056205|SUPERIORITY||Difference in percentage of participants|14.96|STANDARD_ERROR_OF_MEAN|5.78||0.0097|TWO_SIDED|95.0|3.63|26.3|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.30|3.63|0.0097
91582985|NCT03486457|183056205|SUPERIORITY||Difference in percentage of participants|24.89|STANDARD_ERROR_OF_MEAN|8.2||0.0024|TWO_SIDED|95.0|8.81|40.97|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.97|8.81|0.0024
91582986|NCT03486457|183056205|SUPERIORITY||Difference in percentage of participants|-17.93|STANDARD_ERROR_OF_MEAN|11.03||0.1042|TWO_SIDED|95.0|-39.55|3.7|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.70|-39.55|0.1042
91582987|NCT03486457|183056206|SUPERIORITY||LS mean difference|-25.89|STANDARD_ERROR_OF_MEAN|7.858||0.0014|TWO_SIDED|95.0|-41.49|-10.29|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.29|-41.49|0.0014
91582988|NCT03486457|183056206|SUPERIORITY||LS mean difference|-34.91|STANDARD_ERROR_OF_MEAN|8.948||0.0002|TWO_SIDED|95.0|-52.69|-17.13|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-17.13|-52.69|0.0002
91582989|NCT03486457|183056206|SUPERIORITY||LS mean difference|5.31|STANDARD_ERROR_OF_MEAN|10.663||0.62|TWO_SIDED|95.0|-15.9|26.51|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||26.51|-15.90|0.6200
91582990|NCT03486457|183056207|SUPERIORITY||LS mean difference|-39.65|STANDARD_ERROR_OF_MEAN|10.862||0.0004|TWO_SIDED|95.0|-61.21|-18.08|||Mixed Models Analysis|||Month 1, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-18.08|-61.21|0.0004
91582991|NCT03486457|183056207|SUPERIORITY||LS mean difference|-25.18|STANDARD_ERROR_OF_MEAN|8.453||0.0037|TWO_SIDED|95.0|-41.97|-8.4|||Mixed Models Analysis|||Month 1, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-8.40|-41.97|0.0037
91582992|NCT03486457|183056207|SUPERIORITY||LS mean difference|-21.3|STANDARD_ERROR_OF_MEAN|10.423||0.0438|TWO_SIDED|95.0|-42.0|-0.61|||Mixed Models Analysis|||Month 1, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.61|-42.00|0.0438
91582993|NCT03486457|183056207|SUPERIORITY||LS mean difference|-49.11|STANDARD_ERROR_OF_MEAN|10.529|<|0.0001|TWO_SIDED|95.0|-70.03|-28.19|||Mixed Models Analysis|||Month 3, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-28.19|-70.03|<0.0001
91582994|NCT03486457|183056207|SUPERIORITY||LS mean difference|-29.71|STANDARD_ERROR_OF_MEAN|9.47||0.0023|TWO_SIDED|95.0|-48.52|-10.89|||Mixed Models Analysis|||Month 3, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.89|-48.52|0.0023
91582995|NCT03486457|183056207|SUPERIORITY||LS mean difference|-36.78|STANDARD_ERROR_OF_MEAN|10.72||0.0009|TWO_SIDED|95.0|-58.08|-15.49|||Mixed Models Analysis|||Month 3, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.49|-58.08|0.0009
91646501|NCT00689273|183184854|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.28|TWO_SIDED|80.0|-0.46|0.04|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.04|-0.46|0.28
91646502|NCT00689273|183184854|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.28||0.14|TWO_SIDED|80.0|-0.78|-0.06|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.06|-0.78|0.14
91582996|NCT03486457|183056207|SUPERIORITY||LS mean difference|7.03|STANDARD_ERROR_OF_MEAN|10.495||0.5048|TWO_SIDED|95.0|-13.84|27.9|||Mixed Models Analysis|||Month 6, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||27.90|-13.84|0.5048
91582997|NCT03486457|183056207|SUPERIORITY||LS mean difference|9.16|STANDARD_ERROR_OF_MEAN|12.273||0.4575|TWO_SIDED|95.0|-15.24|33.57|||Mixed Models Analysis|||Month 6, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||33.57|-15.24|0.4575
91582998|NCT03486457|183056207|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|11.539||0.9523|TWO_SIDED|95.0|-22.26|23.65|||Mixed Models Analysis|||Month 6, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||23.65|-22.26|0.9523
91582999|NCT03486457|183056208|SUPERIORITY||LS mean difference|-28.69|STANDARD_ERROR_OF_MEAN|8.386||0.0008|TWO_SIDED|95.0|-45.24|-12.15|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.15|-45.24|0.0008
91583000|NCT03486457|183056208|SUPERIORITY||LS mean difference|-46.47|STANDARD_ERROR_OF_MEAN|10.632|<|0.0001|TWO_SIDED|95.0|-67.45|-25.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-25.49|-67.45|<0.0001
91583001|NCT03486457|183056208|SUPERIORITY||LS mean difference|-26.76|STANDARD_ERROR_OF_MEAN|10.778||0.0141|TWO_SIDED|95.0|-48.05|-5.47|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.47|-48.05|0.0141
91583002|NCT03486457|183056209|SUPERIORITY||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|2.399|<|0.0001|TWO_SIDED|95.0|-15.48|-6.02|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.02|-15.48|<0.0001
91583003|NCT03486457|183056209|SUPERIORITY||LS mean difference|-19.45|STANDARD_ERROR_OF_MEAN|2.575|<|0.0001|TWO_SIDED|95.0|-24.52|-14.37|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-14.37|-24.52|<0.0001
91583004|NCT03486457|183056209|SUPERIORITY||LS mean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.289||0.0039|TWO_SIDED|95.0|-11.22|-2.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.18|-11.22|0.0039
91583005|NCT03486457|183056210|SUPERIORITY||Difference in percentage of participants|14.19|STANDARD_ERROR_OF_MEAN|5.89||0.016|TWO_SIDED|95.0|2.64|25.73|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.73|2.64|0.0160
91583006|NCT03486457|183056210|SUPERIORITY||Difference in percentage of participants|25.65|STANDARD_ERROR_OF_MEAN|8.06||0.0015|TWO_SIDED|95.0|9.86|41.44|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.44|9.86|0.0015
91583007|NCT03486457|183056210|SUPERIORITY||Difference in percentage of participants|23.05|STANDARD_ERROR_OF_MEAN|9.16||0.0118|TWO_SIDED|95.0|5.11|41.0|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.00|5.11|0.0118
91583008|NCT03486457|183056211|SUPERIORITY||LS mean difference|-3.09|STANDARD_ERROR_OF_MEAN|1.259||0.0156|TWO_SIDED|95.0|-5.58|-0.6|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.60|-5.58|0.0156
91583009|NCT03486457|183056211|SUPERIORITY||LS mean difference|-4.06|STANDARD_ERROR_OF_MEAN|0.989|<|0.0001|TWO_SIDED|95.0|-6.02|-2.1|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.10|-6.02|<0.0001
91583010|NCT03486457|183056211|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.346||0.0061|TWO_SIDED|95.0|-1.65|-0.28|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.28|-1.65|0.0061
91708359|NCT01763827|183309617|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.14||||0.027|TWO_SIDED|95.0|-17.54|1.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.26|-17.54|0.027
91583011|NCT03486457|183056212|SUPERIORITY||Difference in percentage of participants|13.03|STANDARD_ERROR_OF_MEAN|10.01||0.193|TWO_SIDED|95.0|-6.59|32.64|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.64|-6.59|0.1930
91583012|NCT03486457|183056212|SUPERIORITY||Difference in percentage of participants|24.3|STANDARD_ERROR_OF_MEAN|10.11||0.0162|TWO_SIDED|95.0|4.48|44.11|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||44.11|4.48|0.0162
91708360|NCT01763827|183309617|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-13.23||||0.044|TWO_SIDED|95.0|-21.69|-4.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.77|-21.69|0.044
91583013|NCT03486457|183056212|SUPERIORITY||Difference in percentage of participants|4.07|STANDARD_ERROR_OF_MEAN|10.83||0.7068|TWO_SIDED|95.0|-17.15|25.3|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.30|-17.15|0.7068
91583014|NCT03486457|183056213|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.271||0.2811|TWO_SIDED|95.0|-0.83|0.25|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-0.83|0.2811
91583015|NCT03486457|183056213|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.295||0.214|TWO_SIDED|95.0|-0.96|0.22|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.96|0.2140
91583016|NCT03486457|183056213|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.239||0.2817|TWO_SIDED|95.0|-0.74|0.22|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.74|0.2817
91583017|NCT03486457|183056214|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.182||0.9407|TWO_SIDED|95.0|-0.37|0.35|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.37|0.9407
91583018|NCT03486457|183056214|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.293||0.4295|TWO_SIDED|95.0|-0.81|0.35|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.81|0.4295
91583019|NCT03486457|183056214|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.314||0.2946|TWO_SIDED|95.0|-0.95|0.29|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.29|-0.95|0.2946
91583020|NCT03486457|183056215|SUPERIORITY||Difference in percentage of participants|21.32|STANDARD_ERROR_OF_MEAN|5.62||0.0001|TWO_SIDED|95.0|10.32|32.33|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.33|10.32|0.0001
91583021|NCT03486457|183056215|SUPERIORITY||Difference in percentage of participants|36.03|STANDARD_ERROR_OF_MEAN|6.49|<|0.0001|TWO_SIDED|95.0|23.31|48.75|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||48.75|23.31|<0.0001
91583022|NCT03486457|183056215|SUPERIORITY||Difference in percentage of participants|52.21|STANDARD_ERROR_OF_MEAN|5.79|<|0.0001|TWO_SIDED|95.0|40.86|63.55|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||63.55|40.86|<0.0001
91583023|NCT03486457|183056215|SUPERIORITY||Difference in percentage of participants|39.71|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|26.38|53.03|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||53.03|26.38|<0.0001
91583024|NCT03486457|183056215|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.23||0.011|TWO_SIDED|95.0|4.22|32.55|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.55|4.22|0.0110
91583025|NCT03486457|183056215|SUPERIORITY||Difference in percentage of participants|16.18|STANDARD_ERROR_OF_MEAN|6.8||0.0173|TWO_SIDED|95.0|2.85|29.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.50|2.85|0.0173
91583026|NCT03486457|183056216|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.79|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.47|-0.79|<0.0001
91583027|NCT03486457|183056216|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.99|-0.62|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.62|-0.99|<0.0001
91777582|NCT02059278|183436450|EQUIVALENCE|Analysis at 10 am on Day 42|Mean Difference (Final Values)|0.505||||0.0558|TWO_SIDED|95.0|-0.013|1.024|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.024|-0.013|0.0558
91583028|NCT03486457|183056216|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.105|<|0.0001|TWO_SIDED|95.0|-1.08|-0.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.66|-1.08|<0.0001
91583029|NCT03486457|183056216|SUPERIORITY||LS mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.28|-0.8|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.80|-1.28|<0.0001
91583030|NCT03486457|183056216|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.129||0.0009|TWO_SIDED|95.0|-0.69|-0.18|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.18|-0.69|0.0009
91583031|NCT03486457|183056216|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.145||0.1202|TWO_SIDED|95.0|-0.51|0.06|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.06|-0.51|0.1202
91583032|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.72|STANDARD_ERROR_OF_MEAN|0.998||0.0003|TWO_SIDED|95.0|1.76|5.69|||Mixed Models Analysis|||Month 1, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.69|1.76|0.0003
91583033|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.102||0.0043|TWO_SIDED|95.0|1.01|5.35|||Mixed Models Analysis|||Month 1, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.35|1.01|0.0043
91583034|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.861||0.0004|TWO_SIDED|95.0|1.42|4.82|||Mixed Models Analysis|||Month 1, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.82|1.42|0.0004
91583035|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.54|STANDARD_ERROR_OF_MEAN|0.938||0.0002|TWO_SIDED|95.0|1.69|5.39|||Mixed Models Analysis|||Month 1, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.39|1.69|0.0002
91583036|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|1.203||0.0123|TWO_SIDED|95.0|0.67|5.41|||Mixed Models Analysis|||Month 1, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.41|0.67|0.0123
91583037|NCT03486457|183056217|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.115||0.0216|TWO_SIDED|95.0|0.38|4.78|||Mixed Models Analysis|||Month 1, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.78|0.38|0.0216
91583038|NCT03486457|183056217|SUPERIORITY||LS mean difference|2.04|STANDARD_ERROR_OF_MEAN|1.336||0.129|TWO_SIDED|95.0|-0.6|4.67|||Mixed Models Analysis|||Month 1, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.67|-0.60|0.1290
91583039|NCT03486457|183056217|SUPERIORITY||LS mean difference|1.91|STANDARD_ERROR_OF_MEAN|1.172||0.1043|TWO_SIDED|95.0|-0.4|4.22|||Mixed Models Analysis|||Month 1, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.22|-0.40|0.1043
91583040|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.77|STANDARD_ERROR_OF_MEAN|0.763|<|0.0001|TWO_SIDED|95.0|2.26|5.27|||Mixed Models Analysis|||Month 1, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.27|2.26|<0.0001
91777583|NCT02059278|183436450|EQUIVALENCE|Analysis at 4 pm on Day 42|Mean Difference (Final Values)|0.538||||0.0491|TWO_SIDED|95.0|0.002|1.074|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.074|0.002|0.0491
91583041|NCT03486457|183056217|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.178||0.1318|TWO_SIDED|95.0|-0.54|4.1|||Mixed Models Analysis|||Month 1, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.10|-0.54|0.1318
91583042|NCT03486457|183056217|SUPERIORITY||LS mean difference|2.53|STANDARD_ERROR_OF_MEAN|1.225||0.0402|TWO_SIDED|95.0|0.11|4.95|||Mixed Models Analysis|||Month 3, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.95|0.11|0.0402
91583043|NCT03486457|183056217|SUPERIORITY||LS mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.227||0.0004|TWO_SIDED|95.0|1.99|6.83|||Mixed Models Analysis|||Month 3, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.83|1.99|0.0004
91583044|NCT03486457|183056217|SUPERIORITY||LS mean difference|5.29|STANDARD_ERROR_OF_MEAN|1.069|<|0.0001|TWO_SIDED|95.0|3.18|7.4|||Mixed Models Analysis|||Month 3, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.40|3.18|<0.0001
91583045|NCT03486457|183056217|SUPERIORITY||LS mean difference|5.28|STANDARD_ERROR_OF_MEAN|1.261|<|0.0001|TWO_SIDED|95.0|2.79|7.76|||Mixed Models Analysis|||Month 3, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.76|2.79|<0.0001
91583046|NCT03486457|183056217|SUPERIORITY||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.366||0.1254|TWO_SIDED|95.0|-0.59|4.8|||Mixed Models Analysis|||Month 3, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.80|-0.59|0.1254
91646503|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.55|TWO_SIDED|80.0|-0.52|0.19|||Mixed Models Analysis|||Day 1: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.19|-0.52|0.55
91646504|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.81|-0.09|||Mixed Models Analysis|||Day 2: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.81|0.11
91583047|NCT03486457|183056217|SUPERIORITY||LS mean difference|4.34|STANDARD_ERROR_OF_MEAN|1.186||0.0003|TWO_SIDED|95.0|2.0|6.68|||Mixed Models Analysis|||Month 3, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.68|2.00|0.0003
91583048|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.384||0.014|TWO_SIDED|95.0|0.7|6.16|||Mixed Models Analysis|||Month 3, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.16|0.70|0.0140
91583049|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.47|STANDARD_ERROR_OF_MEAN|1.268||0.0067|TWO_SIDED|95.0|0.97|5.98|||Mixed Models Analysis|||Month 3, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.98|0.97|0.0067
91583050|NCT03486457|183056217|SUPERIORITY||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|2.23|6.12|||Mixed Models Analysis|||Month 3, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.12|2.23|<0.0001
91583051|NCT03486457|183056217|SUPERIORITY||LS mean difference|3.27|STANDARD_ERROR_OF_MEAN|1.248||0.0094|TWO_SIDED|95.0|0.81|5.73|||Mixed Models Analysis|||Month 3, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.73|0.81|0.0094
91583052|NCT03486457|183056217|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.049||0.7098|TWO_SIDED|95.0|-1.68|2.46|||Mixed Models Analysis|||Month 6, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.46|-1.68|0.7098
91583053|NCT03486457|183056217|SUPERIORITY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.234||0.4019|TWO_SIDED|95.0|-1.4|3.47|||Mixed Models Analysis|||Month 6, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.47|-1.40|0.4019
91708361|NCT01763827|183309618|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-4.59||||0.072|TWO_SIDED|95.0|-11.3|2.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.12|-11.30|0.072
91777584|NCT02059278|183436450|EQUIVALENCE|Analysis at 8 am on Day 84|Mean Difference (Final Values)|0.808||||0.0025|TWO_SIDED|95.0|0.286|1.329|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.329|0.286|0.0025
91777585|NCT02059278|183436450|EQUIVALENCE|Analysis at 10 am on Day 84|Mean Difference (Final Values)|0.627||||0.0113|TWO_SIDED|95.0|0.143|1.111|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.111|0.143|0.0113
91583054|NCT03486457|183056217|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.186||0.7537|TWO_SIDED|95.0|-1.97|2.71|||Mixed Models Analysis|||Month 6, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.71|-1.97|0.7537
91583055|NCT03486457|183056217|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|1.33||0.3595|TWO_SIDED|95.0|-1.4|3.85|||Mixed Models Analysis|||Month 6, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.85|-1.40|0.3595
91583056|NCT03486457|183056217|SUPERIORITY||LS mean difference|1.99|STANDARD_ERROR_OF_MEAN|1.52||0.1919|TWO_SIDED|95.0|-1.01|4.99|||Mixed Models Analysis|||Month 6, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.99|-1.01|0.1919
91583057|NCT03486457|183056217|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|1.209||0.8163|TWO_SIDED|95.0|-2.1|2.67|||Mixed Models Analysis|||Month 6, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.67|-2.10|0.8163
91583058|NCT03486457|183056217|SUPERIORITY||LS mean difference|2.23|STANDARD_ERROR_OF_MEAN|1.368||0.1048|TWO_SIDED|95.0|-0.47|4.93|||Mixed Models Analysis|||Month 6, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.93|-0.47|0.1048
91583059|NCT03486457|183056217|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.392||0.6118|TWO_SIDED|95.0|-2.04|3.45|||Mixed Models Analysis|||Month 6, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.45|-2.04|0.6118
91583060|NCT03486457|183056217|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.014||0.6996|TWO_SIDED|95.0|-1.61|2.39|||Mixed Models Analysis|||Month 6, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.39|-1.61|0.6996
91583061|NCT03486457|183056217|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.424||0.2122|TWO_SIDED|95.0|-1.03|4.59|||Mixed Models Analysis|||Month 6, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.59|-1.03|0.2122
91708362|NCT01763827|183309618|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.39|||<|0.001|TWO_SIDED|95.0|-30.11|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.68|-30.11|<0.001
91583062|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0722|TWO_SIDED|95.0|-0.25|0.01|||Mixed Models Analysis|||Month 1, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.25|0.0722
91583063|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.055||0.0035|TWO_SIDED|95.0|-0.27|-0.05|||Mixed Models Analysis|||Month 1, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.05|-0.27|0.0035
91583064|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.069||0.0475|TWO_SIDED|95.0|-0.27|0.0|||Mixed Models Analysis|||Month 1, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.27|0.0475
91583065|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.066||0.0537|TWO_SIDED|95.0|-0.26|0.0|||Mixed Models Analysis|||Month 1, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.26|0.0537
91583066|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.062||0.1977|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|||Month 1, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.04|-0.20|0.1977
91583067|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064||0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||Month 3, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.38|0.0001
91583068|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.057||0.0018|TWO_SIDED|95.0|-0.29|-0.07|||Mixed Models Analysis|||Month 3, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.07|-0.29|0.0018
91583069|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.47|-0.19|||Mixed Models Analysis|||Month 3, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.19|-0.47|<0.0001
91583070|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.073||0.0002|TWO_SIDED|95.0|-0.42|-0.14|||Mixed Models Analysis|||Month 3, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.14|-0.42|0.0002
91583071|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.063||0.0835|TWO_SIDED|95.0|-0.23|0.01|||Mixed Models Analysis|||Month 3, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.23|0.0835
91583072|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.0825|TWO_SIDED|95.0|-0.21|0.01|||Mixed Models Analysis|||Month 6, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.21|0.0825
91777586|NCT02059278|183436450|EQUIVALENCE|Analysis at 4 pm on Day 84|Mean Difference (Final Values)|0.456||||0.0649|TWO_SIDED|95.0|-0.063|0.975|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||0.975|-0.063|0.0649
91583073|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.049||0.5616|TWO_SIDED|95.0|-0.13|0.07|||Mixed Models Analysis|||Month 6, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.07|-0.13|0.5616
91583074|NCT03486457|183056218|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.065||0.0748|TWO_SIDED|95.0|-0.24|0.01|||Mixed Models Analysis|||Month 6, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.24|0.0748
91777587|NCT03955146|183436455|OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.062||0.2926|TWO_SIDED|95.0|-0.06|0.19|||Mixed Models Analysis|||||0.19|-0.06|0.2926
91777588|NCT04363320|183436463|SUPERIORITY||Slope|0.538|STANDARD_DEVIATION|0.169||0.002|TWO_SIDED|||||a prior threshold 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.002
91646505|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|80.0|-0.71|0.0|||Mixed Models Analysis|||Day 3: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.00|-0.71|0.20
91777589|NCT04363320|183436463|SUPERIORITY||Slope|0.38|STANDARD_DEVIATION|0.113||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.0008
91777590|NCT04363320|183436463|SUPERIORITY||Slope|0.207|STANDARD_DEVIATION|0.129||0.111|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.111
91777591|NCT04363320|183436463|SUPERIORITY||Slope|0.017|STANDARD_DEVIATION|0.014||0.235|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.235
91777592|NCT04363320|183436464|SUPERIORITY||Slope|0.153|STANDARD_DEVIATION|0.218||0.485|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.485
91583075|NCT03486457|183056218|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.9477|TWO_SIDED|95.0|-0.15|0.16|||Mixed Models Analysis|||Month 6, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.16|-0.15|0.9477
91583076|NCT03486457|183056218|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.067||0.3829|TWO_SIDED|95.0|-0.07|0.19|||Mixed Models Analysis|||Month 6, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.19|-0.07|0.3829
91583077|NCT03486457|183056219|SUPERIORITY||LS mean difference|6.01|STANDARD_ERROR_OF_MEAN|2.084||0.0044|TWO_SIDED|95.0|1.9|10.12|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||10.12|1.90|0.0044
91583078|NCT03486457|183056219|SUPERIORITY||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|5.71|15.88|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||15.88|5.71|<0.0001
91583079|NCT03486457|183056219|SUPERIORITY||LS mean difference|0.92|STANDARD_ERROR_OF_MEAN|2.442||0.7062|TWO_SIDED|95.0|-3.9|5.74|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.74|-3.90|0.7062
91583080|NCT03486457|183056220|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|2.404||0.7228|TWO_SIDED|95.0|-3.92|5.63|||Mixed Models Analysis|||Month 3, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.63|-3.92|0.7228
91583081|NCT03486457|183056220|SUPERIORITY||LS mean difference|-6.34|STANDARD_ERROR_OF_MEAN|4.561||0.1682|TWO_SIDED|95.0|-15.39|2.72|||Mixed Models Analysis|||Month 3, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.72|-15.39|0.1682
91583082|NCT03486457|183056220|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|4.707||0.19|TWO_SIDED|95.0|-15.56|3.13|||Mixed Models Analysis|||Month 3, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.13|-15.56|0.1900
91583083|NCT03486457|183056220|SUPERIORITY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.581||0.6757|TWO_SIDED|95.0|-6.22|4.05|||Mixed Models Analysis|||Month 6, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.05|-6.22|0.6757
91583084|NCT03486457|183056220|SUPERIORITY||LS mean difference|-2.38|STANDARD_ERROR_OF_MEAN|4.905||0.6285|TWO_SIDED|95.0|-12.13|7.37|||Mixed Models Analysis|||Month 6, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.37|-12.13|0.6285
91583085|NCT03486457|183056220|SUPERIORITY||LS mean difference|-2.63|STANDARD_ERROR_OF_MEAN|5.333||0.6228|TWO_SIDED|95.0|-13.23|7.97|||Mixed Models Analysis|||Month 6, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.97|-13.23|0.6228
91583086|NCT03486457|183056221|SUPERIORITY||LS mean difference|-12.81|STANDARD_ERROR_OF_MEAN|3.089|<|0.0001|TWO_SIDED|95.0|-18.9|-6.72|||Mixed Models Analysis|||Month 3, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.72|-18.90|<0.0001
91583087|NCT03486457|183056221|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|3.157||0.7384|TWO_SIDED|95.0|-5.17|7.28|||Mixed Models Analysis|||Month 6, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.28|-5.17|0.7384
91583088|NCT00372229|183056222|SUPERIORITY_OR_OTHER_LEGACY||Difference|-28.5|STANDARD_ERROR_OF_MEAN|5.45|||TWO_SIDED|96.0|-39.7|-17.3||||||||-17.3|-39.7|
91583089|NCT00372229|183056223|SUPERIORITY_OR_OTHER_LEGACY||Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|96.0|-19.2|-3.4||||||||-3.4|-19.2|
91583090|NCT00372229|183056224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2509|STANDARD_ERROR_OF_MEAN|0.1838||0.1739|TWO_SIDED|99.0|-0.2271|0.7289|||F-test|||||0.7289|-0.2271|0.1739
91646506|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.23|TWO_SIDED|80.0|-0.69|0.02|||Mixed Models Analysis|||Day 4: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.02|-0.69|0.23
91583091|NCT00372229|183056257|OTHER|Descriptive analysis|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.71|||TWO_SIDED|95.0|-20.2|13.9||||||||13.9|-20.2|
91583092|NCT00372229|183056258|OTHER|Descriptive analysis|Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-0.1|24.2||||||||24.2|-0.1|
91583093|NCT04055090|183056276|OTHER||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.438||0.046|TWO_SIDED|95.0|-1.76|-0.02|||Mixed Models Analysis|Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects|Mixed-effects Model for Repeated Measures with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. The Baseline average 24-hour pain score was included as a covariate.|||-0.02|-1.76|0.0460
91583094|NCT04055090|183056278|OTHER|||||||0.219|||||||Cochran-Mantel-Haenszel|||||||0.2190
91583095|NCT04055090|183056279|OTHER||Least-Squares Mean Difference|-1.48||||0.0155|TWO_SIDED|95.0|-2.67|-0.29|||Mixed Models Analysis||Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. Baseline average 24-hour pain score is included as a covariate.|||-0.29|-2.67|0.0155
91583096|NCT05478499|183056286|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.3|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||15.3|2.5|<0.0001
91583097|NCT05478499|183056286|SUPERIORITY||Odds Ratio (OR)|7.0|||<|0.0001|TWO_SIDED|95.0|2.7|18.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||18.4|2.7|<0.0001
91583098|NCT05478499|183056287|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.0001||95.0|4.6|352.0|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||352.0|4.6|<0.0001
91583099|NCT05478499|183056287|SUPERIORITY||Odds Ratio (OR)|37.3|||<|0.0001|TWO_SIDED|95.0|4.4|317.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||317.6|4.4|<0.0001
91583100|NCT05478499|183056288|SUPERIORITY||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.3|-1.6|||analysis of covariance model||analysis of covariance model|Full Analysis Set||-1.6|-3.3|<0.0001
91583101|NCT05478499|183056288|SUPERIORITY||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.3|-1.5|||analysis of covariance model||analysis of covariance model|Patient sub-population (s-PGA ≥ 3)||-1.5|-3.3|<0.0001
91583102|NCT05478499|183056289|SUPERIORITY||Odds Ratio (OR)|23.9|||<|0.0001|TWO_SIDED|95.0|5.4|105.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|||105.6|5.4|<0.0001
91583103|NCT00552240|183056312|NON_INFERIORITY_OR_EQUIVALENCE|A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).|Difference in proportion of responders|-0.041||||0.7142||95.0|-0.183|0.101|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.||0.101|-0.183|0.7142
91583104|NCT00552240|183056313|NON_INFERIORITY_OR_EQUIVALENCE|Same as for the primary analysis|Difference in proportion of responders|-0.027||||0.6479||95.0|-0.167|0.113|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.113|-0.167|0.6479
91583105|NCT00552240|183056314|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|0.084||||0.1477||95.0|-0.03|0.197|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.197|-0.030|0.1477
91777593|NCT04363320|183436464|SUPERIORITY||Slope|0.642|STANDARD_DEVIATION|0.19||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.0008
91777594|NCT04363320|183436464|SUPERIORITY||Slope|-0.377|STANDARD_DEVIATION|0.154||0.015|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)||||0.015
91777595|NCT04363320|183436464|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.017||0.241|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.241
91777596|NCT04363320|183436465|SUPERIORITY||Slope|1.912|STANDARD_DEVIATION|0.438||2e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.00002
91583106|NCT00552240|183056315|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|-0.067||||0.3703||95.0|-0.215|0.08|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.080|-0.215|0.3703
91583107|NCT00552240|183056316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.0314||95.0|0.46|0.964|||Regression, Cox|Controlling for screening viral load and CD4+ categories.||Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.||0.964|0.460|0.0314
91583108|NCT00552240|183056317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0172||95.0|0.428|0.921|||Regression, Cox|Controlling for screening viral load and CD4+ categories||"Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine."||0.921|0.428|0.0172
91777597|NCT04363320|183436465|SUPERIORITY||Slope|0.855|STANDARD_DEVIATION|0.206||4e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.00004
91583109|NCT00552240|183056345|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.8||||0.7315||95.0|-8.4|11.9|||ANCOVA|Controlling for screening viral load and CD4+ categories||||11.9|-8.4|0.7315
91583110|NCT00552240|183056346|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.6||||0.3625||95.0|-33.4|12.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||12.3|-33.4|0.3625
91583111|NCT00552240|183056347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.0164||95.0|0.9|8.8|||ANCOVA|Controlling for screening viral load and CD4+ categories||||8.8|0.9|0.0164
91583112|NCT00552240|183056348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.9257||95.0|-8.4|9.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||9.3|-8.4|0.9257
91583113|NCT00552240|183056349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0375||95.0|-0.64|-0.02|||ANCOVA|Controlling for screening viral load and CD4+ categories||||-0.02|-0.64|0.0375
91583114|NCT00552240|183056350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.4645||95.0|-1.02|0.47|||ANCOVA|Controlling for screening viral load and CD4+ categories||||0.47|-1.02|0.4645
91777598|NCT04363320|183436465|SUPERIORITY||Slope|0.322|STANDARD_DEVIATION|0.206||0.118|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.118
91777599|NCT04363320|183436465|SUPERIORITY||Slope|0.073|STANDARD_DEVIATION|0.031||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.020
91777600|NCT04363320|183436466|SUPERIORITY||Slope|0.617|STANDARD_DEVIATION|0.307||0.045|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.045
91583115|NCT02679573|183056360|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|-0.2|||||TWO_SIDED|95.0|-4.4|4.1|||||Difference = Difference in responder rates (Delafloxacin treatment group minus Moxifloxacin treatment group). Confidence intervals are calculated using Miettinen and Nurminen method without stratification.|"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125 where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) were presented, and the Miettinen-Nurminen test, without stratification, was used for the 2 sided 95% CI on the difference in response rate."||4.1|-4.4|
91583116|NCT02679573|183056361|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|9.7|||||TWO_SIDED|95.0|3.0|16.3||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||16.3|3.0|
91583117|NCT02679573|183056362|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.3|4.8||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.8|-3.3|
91583118|NCT02679573|183056363|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.0|4.6||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.6|-3.0|
91583119|NCT02679573|183056364|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.5|||||TWO_SIDED|95.0|-4.8|5.9||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||5.9|-4.8|
91583120|NCT02679573|183056365|OTHER|||||||0.5951||||||The log-rank test was used to compare the time to all-cause mortality between the 2 treatment groups.|Log Rank|||||||0.5951
91583121|NCT02476279|183056366|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|0.006|0.066|||||These numbers are in the intention-to-treat analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.066|0.006|
91583122|NCT02476279|183056366|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.003|0.06|||||These numbers are in the per protocol analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.060|-0.003|
91583123|NCT02476279|183056367|OTHER||Risk Difference (RD)|0.021|||||TWO_SIDED|95.0|-0.002|0.043|||||These numbers are in the intention-to-treat analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.043|-0.002|
91583124|NCT02476279|183056367|OTHER||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.004|0.044|||||These numbers are in the per protocol analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.044|-0.004|
91583125|NCT00912301|183056377|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Dunnett's test|pairwise comparison low dose NaCDC against placebo||||||0.031
91646507|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_DEVIATION|0.28||0.41|TWO_SIDED|80.0|-0.58|0.13|||Mixed Models Analysis|||Day 5: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.13|-0.58|0.41
91646508|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|80.0|-0.49|0.22|||Mixed Models Analysis|||Day 6: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.22|-0.49|0.62
91583126|NCT00912301|183056377|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Dunnett's test|pairwise comparison high dose NaCDC against placebo||||||0.010
91646509|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.49|TWO_SIDED|80.0|-0.55|0.16|||Mixed Models Analysis|||Day 7: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-0.55|0.49
91646510|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_DEVIATION|0.28||0.1|TWO_SIDED|80.0|-0.81|-0.1|||Mixed Models Analysis|||Day 8: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.10|-0.81|0.10
91646511|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.69|0.03|||Mixed Models Analysis|||Day 9: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.69|0.24
91646512|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.02|TWO_SIDED|80.0|-1.01|-0.28|||Mixed Models Analysis|||Day 10: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.28|-1.01|0.02
91708363|NCT01763827|183309618|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.71||||0.082|TWO_SIDED|95.0|-14.13|2.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.71|-14.13|0.082
91583127|NCT00116753|183056399|SUPERIORITY_OR_OTHER||Percentage of partcipants|78.3|||||TWO_SIDED|96.5|69.0|86.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||86|69|
91583128|NCT00116753|183056399|SUPERIORITY_OR_OTHER||Percentage of participants|79.5|||||TWO_SIDED|96.5|71.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|71|
91583129|NCT00116753|183056399|SUPERIORITY_OR_OTHER||Percentage of participants|85.3|||||TWO_SIDED|96.5|77.0|91.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||91|77|
91646513|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.93|-0.21|||Mixed Models Analysis|||Day 11: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.21|-0.93|0.04
91646514|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.95|-0.23|||Mixed Models Analysis|||Day 12: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.23|-0.95|0.04
91646515|NCT00689273|183184855|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.7|0.03|||Mixed Models Analysis|||Day 13: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.70|0.24
91708364|NCT01763827|183309618|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.84||||0.044|TWO_SIDED|95.0|-22.14|-3.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baselie value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-3.54|-22.14|0.044
91646516|NCT00689273|183184855|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.82|-0.09|||Mixed Models Analysis|||Day 14: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.82|0.11
91646517|NCT00689273|183184856|SUPERIORITY|||||||0.22|||||||Cochran-Mantel-Haenszel|||30% Reduction||||0.22
91708365|NCT01763827|183309619|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.94||||0.72|TWO_SIDED|95.0|-18.81|2.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.92|-18.81|0.72
91583130|NCT00116753|183056399|SUPERIORITY_OR_OTHER|||||||0.3022||95.0|||||Mantel Haenszel|||||||0.3022
91583131|NCT00116753|183056399|SUPERIORITY_OR_OTHER|||||||0.7797||95.0|||||Mantel Haenszel|||||||0.7797
91583132|NCT00116753|183056399|SUPERIORITY_OR_OTHER|||||||0.1557||95.0|||||Mantel Haenszel|||||||0.1557
91708366|NCT01763827|183309619|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-16.33|||<|0.001|TWO_SIDED|95.0|-25.64|-7.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.02|-25.64|<0.001
91777601|NCT04363320|183436466|SUPERIORITY||Slope|1.103|STANDARD_DEVIATION|0.229||2e-06|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.000002
91583133|NCT00116753|183056399|SUPERIORITY_OR_OTHER|||||||0.2208||95.0|||||Mantel Haenszel|||||||0.2208
91583134|NCT00116753|183056400|SUPERIORITY_OR_OTHER||Percentage of participants|80.7|||||TWO_SIDED|96.5|72.0|88.0|||||Estimated value is the percentage of participants with all testosterone values from after Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||88|72|
91583135|NCT00116753|183056400|SUPERIORITY_OR_OTHER||Percentage of participants|80.2|||||TWO_SIDED|96.5|72.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|72|
91583136|NCT00116753|183056400|SUPERIORITY_OR_OTHER||Percentage of participants|86.0|||||TWO_SIDED|96.5|78.0|92.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||92|78|
91583137|NCT00116753|183056400|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Mantel Haenszel|||||||0.3830
91583138|NCT00116753|183056400|SUPERIORITY_OR_OTHER|||||||0.9587||95.0|||||Mantel Haenszel|||||||0.9587
91583139|NCT00116753|183056400|SUPERIORITY_OR_OTHER|||||||0.2579||95.0|||||Mantel Haenszel|||||||0.2579
91583140|NCT00116753|183056400|SUPERIORITY_OR_OTHER|||||||0.2072||95.0|||||Mantel Haenszel|||||||0.2072
91583141|NCT00116753|183056401|SUPERIORITY_OR_OTHER||Percentage of participants|97.3|||||TWO_SIDED|95.0|93.0|99.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||99|93|
91583142|NCT00116753|183056401|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
91583143|NCT00116753|183056401|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
91583144|NCT01200589|183056404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.89|1.49||||||||1.49|0.89|
91583145|NCT00986973|183056414|SUPERIORITY_OR_OTHER||||||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
91583146|NCT00986973|183056415|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.82
91583147|NCT00986973|183056416|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.46
91583148|NCT00986973|183056417|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.071
91583149|NCT00986973|183056418|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.25
91583150|NCT00986973|183056419|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.050
91777602|NCT04363320|183436466|SUPERIORITY||Slope|-0.387|STANDARD_DEVIATION|0.218||0.076|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)||||0.076
91583151|NCT00986973|183056420|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
91583152|NCT00598273|183056421|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|97.5|-0.19|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.26|-0.19|
91613261|NCT03478878|183120989|SUPERIORITY||Mean Difference (Final Values)|1.83||||0.705|TWO_SIDED|95.0|-9.43|13.11||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||13.11|-9.43|0.705
91646518|NCT00689273|183184856|SUPERIORITY|||||||0.38|||||||Cochran-Mantel-Haenszel|||50% Reduction||||0.38
91646519|NCT00689273|183184857|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED|80.0|-0.27|0.07|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.07|-0.27|0.45
91777603|NCT04363320|183436466|SUPERIORITY||Slope|0.086|STANDARD_DEVIATION|0.036||0.019|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.019
91583153|NCT00598273|183056421|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|97.5|0.04|0.48|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.48|0.04|
91583154|NCT00598273|183056422|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.51|3.1|||Cochran-Mantel-Haenszel|||||3.10|0.51|
91583155|NCT00598273|183056422|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.62|3.56|||Cochran-Mantel-Haenszel|||||3.56|0.62|
91583156|NCT00598273|183056423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.94|1.05|||Cochran-Mantel-Haenszel|||||1.05|0.94|
91583157|NCT00598273|183056423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.95|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.95|
91646520|NCT00689273|183184857|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.37|TWO_SIDED|80.0|-0.29|0.05|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.05|-0.29|0.37
91646521|NCT03703297|183184876|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.01608|TWO_SIDED|95.0|0.606|0.95|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.|||0.950|0.606|0.01608
91708367|NCT01763827|183309619|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.58||||0.082|TWO_SIDED|95.0|-18.1|0.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||0.94|-18.10|0.082
91583158|NCT01323972|183056430|OTHER||GMT ratio|1.32|||||TWO_SIDED|95.0|1.06|1.65|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 2 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.65|1.06|
91583159|NCT01323972|183056430|OTHER||GMT ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.32|0.85|
91583160|NCT01323972|183056430|OTHER||GMT ratio|0.8||||||95.0|0.64|1.0|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 2 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1|0.64|
91583161|NCT01323972|183056430|NON_INFERIORITY|Non-inferiority was demonstrated if one month post Dose 3, the upper limit (UL) of the 2-sided 95% CI of the GMT ratio of the pilot scale lot (Control Group) over the pooled commercial scale lots (Pooled Log Group) was below 2.|GMT ratio|0.95||||||95.0|0.79|1.15||||||Demonstration of non-inferiority of the commercial scale lots of GSK 257049 to the pilot scale lot in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.15|0.79|
91583162|NCT03218397|183056455|SUPERIORITY||Difference in means|5.6||||0.013|TWO_SIDED|95.0|1.2|10.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||10|1.2|0.013
91583163|NCT03218397|183056456|SUPERIORITY|||||||0.265||||||alpha = 0.05|Fisher Exact|||||||0.265
91583164|NCT03218397|183056457|SUPERIORITY|||||||0.093||||||alpha = 0.05|t-test, 2 sided|T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.||||||0.093
91583165|NCT03218397|183056458|SUPERIORITY|||||||0.014||||||alpha = 0.05|Fisher Exact|||||||0.014
91583166|NCT03218397|183056459|SUPERIORITY||Difference in means|7.5||||0.009|TWO_SIDED|95.0|1.9|13.1||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||13.1|1.9|0.009
91708368|NCT01763827|183309619|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.72||||0.044|TWO_SIDED|95.0|-20.89|-4.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.54|-20.89|0.044
91583167|NCT03218397|183056460|SUPERIORITY||Difference in means|6.5||||0.022|TWO_SIDED|95.0|0.9|12.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||12.0|0.9|0.022
91583168|NCT03218397|183056461|SUPERIORITY||Difference in means|0.7||||0.46|TWO_SIDED|95.0|-1.2|2.7||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.7|-1.2|0.46
91583169|NCT03218397|183056462|SUPERIORITY||Difference in means|4.6||||0.074|TWO_SIDED|95.0|-0.4|9.6||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||9.6|-0.4|0.074
91583170|NCT03218397|183056463|SUPERIORITY||Difference in means|6.5||||0.008|TWO_SIDED|95.0|1.7|11.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||11.2|1.7|0.008
91583171|NCT03218397|183056464|SUPERIORITY||Difference in means|-1.9||||0.37|TWO_SIDED|95.0|-5.9|2.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.2|-5.9|0.37
91646522|NCT03703297|183184877|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.01042|TWO_SIDED|95.0|0.569|0.928|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI were calculated using stratified Cox proportional hazards model, adjusting for receipt of PCI, with treatment as only covariate and ties handled by Efron approach.|||0.928|0.569|0.01042
91777604|NCT03605667|183436472|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.93||0.9809|TWO_SIDED|95.0|-1.8|1.8|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, mini-mental state examination (MMSE) randomization stratification, apolipoprotein E (APoE) status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||1.8|-1.8|0.9809
91583172|NCT01049217|183056484|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.191||0.709|TWO_SIDED|95.0|-0.3|0.45|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with terms of treatment, pooled site, dideoxynucleoside analogue (D-drug) anti-retroviral agent (ART) use and baseline score.||0.45|-0.30|0.7090
91583173|NCT01049217|183056485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.5049
91583174|NCT01049217|183056486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4271|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.4271
91583175|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.2084|TWO_SIDED|95.0|-0.31|0.07|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.31|0.2084
91583176|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.126||0.1516|TWO_SIDED|95.0|-0.43|0.07|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.43|0.1516
91583177|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0468|TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.00|-0.56|0.0468
91583178|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.1224|TWO_SIDED|95.0|-0.62|0.07|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.62|0.1224
91583179|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.184||0.0373|TWO_SIDED|95.0|-0.75|-0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.02|-0.75|0.0373
91583180|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.199||0.166|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.12|-0.67|0.1660
91583181|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.214||0.3246|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.21|-0.63|0.3246
91583182|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.219||0.4879|TWO_SIDED|95.0|-0.58|0.28|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.28|-0.58|0.4879
91583183|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.223||0.2669|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.19|-0.69|0.2669
91583184|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.219||0.5452|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.30|-0.56|0.5452
91583185|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.229||0.5469|TWO_SIDED|95.0|-0.59|0.31|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.59|0.5469
91583186|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.7843|TWO_SIDED|95.0|-0.54|0.41|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.54|0.7843
91583187|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9008|TWO_SIDED|95.0|-0.5|0.44|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.44|-0.50|0.9008
91583188|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9064|TWO_SIDED|95.0|-0.45|0.5|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.45|0.9064
91583189|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.243||0.7205|TWO_SIDED|95.0|-0.57|0.39|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.39|-0.57|0.7205
91646523|NCT03958071|183184901|OTHER||Absolute standardized differences (ASD)|-0.1027||||0.281|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.2810
91646524|NCT03958071|183184901|OTHER||Absolute standardized differences (ASD)|-0.078||||0.1421|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1421
91583190|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.259||0.4334|TWO_SIDED|95.0|-0.71|0.31|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.71|0.4334
91583191|NCT01049217|183056487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.199||0.8402|TWO_SIDED|95.0|-0.43|0.35|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.35|-0.43|0.8402
91646525|NCT03958071|183184901|OTHER||Absolute standardized differences (ASD)|0.0159||||0.0048|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0048
91646526|NCT03958071|183184903|OTHER||Absolute standardized differences (ASD)|0.0214||||0.7681|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7681
91646527|NCT03958071|183184903|OTHER||Absolute standardized differences (ASD)|0.371|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
91583192|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.3098|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.08|-0.25|0.3098
91583193|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.118||0.2429|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.09|-0.37|0.2429
91646528|NCT03958071|183184903|OTHER||Absolute standardized differences (ASD)|0.349|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
91583194|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.137||0.0504|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.00|-0.54|0.0504
91708369|NCT01763827|183309620|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.007|TWO_SIDED|95.0|2.23|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.23|0.007
91583195|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.164||0.1141|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.06|-0.58|0.1141
91583196|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.173||0.0667|TWO_SIDED|95.0|-0.66|0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.02|-0.66|0.0667
91583197|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.189||0.2104|TWO_SIDED|95.0|-0.61|0.13|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.13|-0.61|0.2104
91646529|NCT03958071|183184904|OTHER||Absolute standardized differences (ASD)|-0.1257||||0.1659|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1659
91646530|NCT03958071|183184904|OTHER||Absolute standardized differences (ASD)|0.1566||||0.0112|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0112
91646531|NCT03958071|183184904|OTHER||Absolute standardized differences (ASD)|0.3019|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
91646532|NCT03958071|183184905|OTHER||Absolute standardized differences (ASD)|-0.0209||||0.326|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.3260
91646533|NCT03958071|183184905|OTHER||Absolute standardized differences (ASD)|-0.2694|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
91708370|NCT01763827|183309620|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|8.48|||<|0.001|TWO_SIDED|95.0|5.53|11.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||11.43|5.53|<0.001
91583198|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.197||0.483|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.25|-0.53|0.4830
91583199|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.5757|TWO_SIDED|95.0|-0.51|0.29|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.29|-0.51|0.5757
91583200|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.208||0.3231|TWO_SIDED|95.0|-0.62|0.2|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.62|0.3231
91583201|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.212||0.3143|TWO_SIDED|95.0|-0.63|0.2|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.63|0.3143
91583202|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.222||0.63|TWO_SIDED|95.0|-0.54|0.33|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.54|0.6300
91583203|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.227||0.5752|TWO_SIDED|95.0|-0.57|0.32|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.32|-0.57|0.5752
91583204|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.219||0.8905|TWO_SIDED|95.0|-0.46|0.4|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.46|0.8905
91583205|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.228||0.9991|TWO_SIDED|95.0|-0.45|0.45|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.45|-0.45|0.9991
91583206|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.228||0.8927|TWO_SIDED|95.0|-0.48|0.42|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.48|0.8927
91583207|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.245||0.8067|TWO_SIDED|95.0|-0.54|0.42|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.54|0.8067
91583208|NCT01049217|183056488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.19||0.9009|TWO_SIDED|95.0|-0.35|0.4|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.35|0.9009
91583209|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.177||0.0948|TWO_SIDED|95.0|-0.64|0.05|||ANCOVA|||Change at Week 4, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.64|0.0948
91583210|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.203||0.4167|TWO_SIDED|95.0|-0.57|0.23|||ANCOVA|||Change at Week 8, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.23|-0.57|0.4167
91583211|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.226||0.8179|TWO_SIDED|95.0|-0.39|0.5|||ANCOVA|||Change at Week 12, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.39|0.8179
91583212|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209||0.6913|TWO_SIDED|95.0|-0.33|0.5|||ANCOVA|||Change at Week 16, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.33|0.6913
91583213|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.203||0.9475|TWO_SIDED|95.0|-0.39|0.41|||ANCOVA|||Change at Endpoint, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.39|0.9475
91646534|NCT03958071|183184905|OTHER||Absolute standardized differences (ASD)|-0.2352|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
91583214|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.204||0.7412|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 4, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.47|0.7412
91583215|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.213||0.9715|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Change at Week 8, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.43|-0.41|0.9715
91583216|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.218||0.8163|TWO_SIDED|95.0|-0.38|0.48|||ANCOVA|||Change at Week 12, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.48|-0.38|0.8163
91583217|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.204||0.3682|TWO_SIDED|95.0|-0.22|0.58|||ANCOVA|||Change at Week 16, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.22|0.3682
91583218|NCT01049217|183056489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.199||0.3511|TWO_SIDED|95.0|-0.21|0.58|||ANCOVA|||Change at Endpoint, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.21|0.3511
91583219|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9686|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Burning: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9686
91583220|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4476|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Squeezing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.4476
91583221|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.563|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Pressure: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.5630
91583222|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9937|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Electric Shocks: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9937
91583223|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8718|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Stabbing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8718
91583224|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.8241|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Change at Endpoint, Light Touching: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.4|-0.5|0.8241
91583225|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3164|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Change at Endpoint, Pressure of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.2|-0.7|0.3164
91583226|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8996|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Cold of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8996
91583227|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9676|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Pins and Needles: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9676
91583228|NCT01049217|183056490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9091|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Tingling: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9091
91583229|NCT01049217|183056491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Duration of Spontaneous Pain: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7300
91583230|NCT01049217|183056491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0559|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Number of Pain Attacks: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.0559
91777605|NCT03605667|183436473|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4474|TWO_SIDED|95.0|-0.8|0.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APoE status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||0.3|-0.8|0.4474
91583231|NCT01049217|183056492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.9686|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||Change at Endpoint, Burning Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.05|0.9686
91583232|NCT01049217|183056492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.4711|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||Change at Endpoint, Pressing Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.06|0.4711
91583233|NCT01049217|183056492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.9215|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|||Change at Endpoint, Paroxysmal Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.04|0.9215
91583234|NCT01049217|183056492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.6042|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Change at Endpoint, Evoked Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.05|0.6042
91583235|NCT01049217|183056492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024||0.9394|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Change at Endpoint, P/D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.04|-0.05|0.9394
91708371|NCT01763827|183309620|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|4.81||||0.013|TWO_SIDED|95.0|0.85|8.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.78|0.85|0.013
91708372|NCT01763827|183309620|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|3.81||||0.044|TWO_SIDED|95.0|-0.77|8.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline visit|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.39|-0.77|0.044
91583236|NCT01049217|183056492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.7801|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Change at Endpoint, Total Score: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.04|0.7801
91708373|NCT01763827|183309621|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.91||||0.007|TWO_SIDED|95.0|1.67|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||10.16|1.67|0.007
91583237|NCT01049217|183056493|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|6.58||0.6012|TWO_SIDED||||||ANCOVA|||Endpoint TST: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.6012
91708374|NCT01763827|183309621|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|9.33|||<|0.001|TWO_SIDED|95.0|5.32|13.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||13.34|5.32|<0.001
91708375|NCT01763827|183309621|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|7.56||||0.013|TWO_SIDED|95.0|3.11|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||12.00|3.11|0.013
91708376|NCT01763827|183309621|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.044|TWO_SIDED|95.0|2.22|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.22|0.044
91708377|NCT04957212|183309678|EQUIVALENCE|We used an equivalence margin of 0.2 for the primary endpoint.|Risk Difference (RD)|-0.04||||0.54|TWO_SIDED|95.0|-0.16|0.09|||Chi-squared|||||0.09|-0.16|0.54
91708378|NCT04957212|183309679|OTHER||Risk Difference (RD)|-0.07||||0.26|TWO_SIDED|95.0|-0.21|0.06|||Chi-squared|||||0.06|-0.21|0.26
91708379|NCT04957212|183309680|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
91708380|NCT04957212|183309681|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
91583238|NCT01049217|183056493|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.89||0.0534|TWO_SIDED||||||ANCOVA|||Endpoint MIS: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0534
91583239|NCT01049217|183056494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.62||0.0966|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0966
91583240|NCT01049217|183056495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.51||0.0611|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0611
91583241|NCT01049217|183056496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8436.0|STANDARD_ERROR_OF_MEAN|6855.2||0.2195|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.2195
91646535|NCT03958071|183184906|OTHER||Absolute standardized differences (ASD)|0.09||||0.2042|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.2042
91646536|NCT03958071|183184906|OTHER||Absolute standardized differences (ASD)|0.21|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
91646537|NCT03958071|183184906|OTHER||Absolute standardized differences (ASD)|0.11||||0.02|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.02
91583242|NCT01049217|183056497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.66||0.8241|TWO_SIDED||||||ANCOVA|||||||0.8241
91646538|NCT03958071|183184907|OTHER||Absolute standardized differences (ASD)|0.0241||||0.7395|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7395
91646539|NCT03958071|183184907|OTHER||Absolute standardized differences (ASD)|0.1644||||0.0017|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0017
91646540|NCT03958071|183184907|OTHER||Absolute standardized differences (ASD)|0.1403||||0.0034|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0034
91583243|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|2.052||0.8528|TWO_SIDED|95.0|-4.42|3.66|||ANCOVA|||Change at Endpoint, Sleep Disturbance: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.66|-4.42|0.8528
91583244|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|3.179||0.365|TWO_SIDED|95.0|-3.37|9.14|||ANCOVA|||Change at Endpoint, Snoring: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||9.14|-3.37|0.3650
91583245|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|2.525||0.7237|TWO_SIDED|95.0|-4.07|5.86|||ANCOVA|||Change at Endpoint, SOB: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.86|-4.07|0.7237
91583246|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.165||0.2783|TWO_SIDED|95.0|-0.5|0.15|||ANCOVA|||Change at Endpoint, Quantity: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.15|-0.50|0.2783
91583247|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.02|STANDARD_ERROR_OF_MEAN|2.611||0.2475|TWO_SIDED|95.0|-2.11|8.16|||ANCOVA|||Change at Endpoint, Adequacy: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||8.16|-2.11|0.2475
91583248|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.16|STANDARD_ERROR_OF_MEAN|1.933||0.5492|TWO_SIDED|95.0|-2.64|4.96|||ANCOVA|||Change at Endpoint, Somnolence: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.96|-2.64|0.5492
91583249|NCT01049217|183056498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.614||0.9113|TWO_SIDED|95.0|-3.0|3.36|||ANCOVA|||Change at Endpoint, Sleep Problems Index: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.36|-3.00|0.9113
91583250|NCT01049217|183056499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Endpoint: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7399
91583251|NCT01049217|183056500|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.386||0.8258|TWO_SIDED|95.0|-0.67|0.84|||ANCOVA|||Change at Endpoint, HADS-A: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.84|-0.67|0.8258
91583252|NCT01049217|183056500|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.372||0.084|TWO_SIDED|95.0|-0.09|1.38|||ANCOVA|||Change at Endpoint, HADS-D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.38|-0.09|0.0840
91583253|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.393||0.6114|TWO_SIDED|95.0|-3.49|5.92|||ANCOVA|||Change at Endpoint, Ph Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.92|-3.49|0.6114
91583254|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|2.522||0.8209|TWO_SIDED|95.0|-4.39|5.53|||ANCOVA|||Change at Endpoint, R-P: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.53|-4.39|0.8209
91583255|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|2.335||0.9737|TWO_SIDED|95.0|-4.52|4.67|||ANCOVA|||Change at Endpoint, BP: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.67|-4.52|0.9737
91583256|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|1.937||0.6966|TWO_SIDED|95.0|-3.05|4.57|||ANCOVA|||Change at Endpoint, GH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.57|-3.05|0.6966
91583257|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.807||0.8569|TWO_SIDED|95.0|-1.44|1.73|||ANCOVA|||Change at Endpoint, Ph C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.73|-1.44|0.8569
91583258|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.847||0.4734|TWO_SIDED|95.0|-4.96|2.31|||ANCOVA|||Change at Endpoint, Vit: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.31|-4.96|0.4734
91583259|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|2.159||0.3625|TWO_SIDED|95.0|-6.22|2.28|||ANCOVA|||Change at Endpoint, So Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.28|-6.22|0.3625
91583260|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.543||0.2736|TWO_SIDED|95.0|-2.21|7.79|||ANCOVA|||Change at Endpoint, R-E: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||7.79|-2.21|0.2736
91583261|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.811||0.8199|TWO_SIDED|95.0|-3.98|3.15|||ANCOVA|||Change at Endpoint, MnH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.15|-3.98|0.8199
91583262|NCT01049217|183056501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.967||0.9361|TWO_SIDED|95.0|-1.82|1.98|||ANCOVA|||Change at Endpoint, Mn C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.98|-1.82|0.9361
91583263|NCT00589121|183056517|SUPERIORITY_OR_OTHER|The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).||||||0.0005|||||||Fisher Exact|||Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.||||0.0005
91583264|NCT02495792|183056535|OTHER||Risk Ratio (RR)|5.98|||||TWO_SIDED|95.0|1.6|21.7||||||||21.7|1.6|
91583265|NCT03519971|183056536|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.247|TWO_SIDED|95.0|0.647|1.123|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||The hazard ratio (HR) and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for age \[\< 65 versus (vs.) \>= 65 years\] and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.||1.123|0.647|0.247
91583266|NCT03519971|183056537|SUPERIORITY||Difference in percentages|0.2||||0.976|TWO_SIDED|99.5|-15.2|16.3|||Cochran-Mantel-Haenszel|The analysis was performed using a Cochran-Mantel-Haenszel (CMH) test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|The CIs for difference in percentages were estimated using Miettinen and Nurminen's method.|||16.3|-15.2|0.976
91583267|NCT03519971|183056538|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|1.03||||0.823|TWO_SIDED|95.0|0.778|1.386|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.386|0.778|0.823
91583268|NCT03519971|183056539|SUPERIORITY|For the comparison between treatments, the Kaplan-Meier estimator of survival at 24 months for each treatment was used to obtain the HR and the test is based on the method described in Klein 2007. To account for the stratification factors, the estimates and test statistics in each strata were combined by weighting inversely proportionately according to each within stratum variance.|Hazard Ratio (HR)|1.04||||0.847|TWO_SIDED|95.0|0.716|1.502|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.502|0.716|0.847
91583269|NCT03519971|183056540|SUPERIORITY|The analysis was performed using a CMH test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|Difference in percentages|0.0|||||TWO_SIDED|95.0|-4.8|3.0|||||The CIs for difference in percentages was calculated using Miettinen and Nurminen's method.|||3.0|-4.8|
91583270|NCT03519971|183056543|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.95||||0.79|TWO_SIDED|95.0|0.649|1.413|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.413|0.649|0.790
91583271|NCT03519971|183056544|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.81||||0.132|TWO_SIDED|95.0|0.614|1.071|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.071|0.614|0.132
91583272|NCT02545933|183056552|SUPERIORITY||least square mean difference|27.0||||0.011|TWO_SIDED|95.0|19.0|34.0|||ANOVA||DAPT group vs DAPT plus vorapaxar group|We hypothesized that adjunctive vorapaxar would result in a significant reduction of CAT-induced platelet aggregation. Assuming a 10% absolute reduction in CAT-induced maximal platelet aggregation with a common standard deviation of 13%, 37 patients per group with valid primary endpoint data were required to detect a significant difference with a 90% power and 2-sided alpha=0.05.||34|19|0.011
91583273|NCT05180500|183056560|OTHER|||||||0.7|||||||Fisher Exact|||||||.70
91583274|NCT05180500|183056561|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
91583275|NCT05180500|183056564|OTHER|||||||0.28|||||||Fisher Exact|||||||0.28
91583276|NCT05180500|183056565|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
91708381|NCT03299101|183309711|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.||||0.872
91583277|NCT05180500|183056566|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
91583278|NCT05180500|183056567|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
91583279|NCT05180500|183056568|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
91583280|NCT05180500|183056569|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91583281|NCT01775124|183056587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.95|-0.2|||ANOVA|||Descriptive, no hypothesis||-0.2|-2.95|
91583282|NCT02317432|183056603|SUPERIORITY||Slope|-0.12|||<|0.01|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.01
91583283|NCT02317432|183056604|SUPERIORITY||Slope|0.6||||0.03|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.03
91583284|NCT02317432|183056605|SUPERIORITY||Slope|6.0||||0.02|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.02
91583285|NCT02317432|183056606|SUPERIORITY||Slope|-1.24||||0.15|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.15
91583286|NCT02317432|183056607|SUPERIORITY||Slope|-0.49||||0.35|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.35
91583287|NCT00346268|183056616|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-7.58|STANDARD_ERROR_OF_MEAN|3.55||0.035|TWO_SIDED|95.0|-14.63|-0.53||Adjusted for treatment group and center|ANOVA|||||-0.53|-14.63|0.035
91708382|NCT03299101|183309711|SUPERIORITY||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|0.71||0.423|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.||||0.423
91583288|NCT00346268|183056617|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-15.16|STANDARD_ERROR_OF_MEAN|5.2||0.004|TWO_SIDED|95.0|-25.47|-4.85||Adjusted for treatment group and center|ANOVA|||||-4.85|-25.47|0.004
91583289|NCT00346268|183056618|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Log Rank|Stratified by center||||||0.257
91583290|NCT00346268|183056619|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.07|STANDARD_ERROR_OF_MEAN|0.3||0.81|TWO_SIDED|95.0|-0.68|0.53||Adjusted for treatment group and center|ANCOVA|Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume||||0.53|-0.68|0.810
91583291|NCT00346268|183056621|SUPERIORITY_OR_OTHER||Least squares mean difference (net)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED|95.0|-0.01|0.35|||ANOVA|||The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.||0.35|-0.01|0.070
91583292|NCT00346268|183056621|SUPERIORITY_OR_OTHER||LS Mean Difference (net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.074|TWO_SIDED|95.0|-0.02|0.33|||ANOVA|||The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.||0.33|-0.02|0.074
91583293|NCT00346268|183056622|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.71|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.16|-0.26||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.26|-1.16|0.002
91583294|NCT00346268|183056622|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.73|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.22|-0.23||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.23|-1.22|0.004
91583295|NCT00346268|183056623|SUPERIORITY_OR_OTHER||LS mean difference (net)|-1.16|STANDARD_ERROR_OF_MEAN|0.3||0.001|TWO_SIDED|95.0|-1.77|-0.56||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.56|-1.77|0.001
91646541|NCT02414854|183184908|SUPERIORITY|Hierarchical testing procedure was used to control type I error rate at 0.05 level. The procedure included the 2 primary outcome measures and the first 13 secondary outcome measures reported and considered 2 pair-wise comparisons: Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w and Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w. Testing order is specified in analysis description.|Relative risk|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Hierarchical testing sequence performed continued only when previous outcome measures was statistically significant at 0.05. Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.||0.68|0.43|<0.0001
91583296|NCT00346268|183056623|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.83|STANDARD_ERROR_OF_MEAN|0.3||0.006|TWO_SIDED|95.0|-1.41|-0.24||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.24|-1.41|0.006
91583297|NCT04487834|183056637|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91583298|NCT04487834|183056638|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
91583299|NCT04487834|183056639|SUPERIORITY|||||||0.4852|||||||Fisher Exact|||||||0.4852
91583300|NCT02831387|183056645|SUPERIORITY||Mean Difference (Net)|-1.88||||0.749|TWO_SIDED|95.0|-13.696|9.936|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in the Subject Reported Dry Eye Questionnaire||9.936|-13.696|0.749
91583301|NCT02831387|183056646|SUPERIORITY||Mean Difference (Net)|-6.6||||0.267|TWO_SIDED|95.0|-18.4|5.3|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Frequency Scores||5.3|-18.4|0.267
91583302|NCT02831387|183056647|SUPERIORITY||Mean Difference (Net)|3.9||||0.495|TWO_SIDED|95.0|-7.6|15.4|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Severity Scores||15.4|-7.6|0.495
91583303|NCT02831387|183056648|SUPERIORITY||Mean Difference (Net)|0.6||||0.316|TWO_SIDED|95.0|-0.6|1.9|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Fluorescein Staining of the Cornea||1.9|-0.6|0.316
91583304|NCT02831387|183056649|SUPERIORITY||Mean Difference (Net)|-0.2||||0.823|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva||1.5|-1.9|0.823
91583305|NCT02831387|183056650|SUPERIORITY||Odds Ratio (OR)|1.923|||||TWO_SIDED|95.0|0.515|7.184||||||Statistical Analysis 1 for the Number of participants with at least 20% improvement in symptoms from baseline to Day 29||7.184|0.515|
91583306|NCT02831387|183056651|SUPERIORITY||Mean Difference (Net)|1.666||||0.723|TWO_SIDED|95.0|-7.759|11.092|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score||11.092|-7.759|0.723
91583307|NCT00192647|183056652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2893|TWO_SIDED|95.0|0.88|1.52|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by viral load and country||||1.52|0.88|0.2893
91583308|NCT00192647|183056653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.91|1.63||||||||1.63|0.91|
91583309|NCT00192647|183056654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.24|2.27||||||Week 4||2.27|1.24|
91583310|NCT00192647|183056654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.24|2.17||||||Week 8||2.17|1.24|
91583311|NCT00192647|183056654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.4|2.53||||||Week 12||2.53|1.40|
91583312|NCT00192647|183056654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.08|1.98||||||Week 24||1.98|1.08|
91583313|NCT01828073|183056660|OTHER||Clopper-Pearson Confidence Interval (CI)|31.82|||||TWO_SIDED|90.0|16.0|51.5|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)||51.50|16.00|
91583314|NCT01828073|183056660|OTHER||Clopper-Pearson Confidence Interval (CI)|50.0|||||TWO_SIDED|90.0|29.1|70.9|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)||70.90|29.10|
91583315|NCT01828073|183056664|OTHER|||||||0.747||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.||||0.747
91583316|NCT01828073|183056664|OTHER|||||||0.341||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.||||0.341
91583317|NCT00118755|183056679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3883|TWO_SIDED|95.0|0.67|1.17|||Log Rank|||||1.17|0.67|0.3883
91583318|NCT00118755|183056680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2458|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2458
91583319|NCT00118755|183056681|SUPERIORITY_OR_OTHER||Difference in Response Rate|9.8||||||95.0|0.9|18.7|||||95% Wald asymptotic CI using normal approximation (continuity corrected)|||18.7|0.9|
91583320|NCT00118755|183056682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.6294||95.0|0.66|1.97|||Log Rank|||||1.97|0.66|0.6294
91583321|NCT01765192|183056683|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.039||0.013|TWO_SIDED|95.0|0.0219|0.1795|||ANCOVA|||The primary endpoint was analyzed using an analysis of covariance model adapted for the crossover design. The following fixed factors and covariates were included in the model: Treatment, sequence, period, and baseline FEV1 measurement of the respective treatment period. The reported analysis results are for the 2 crossover treatment periods combined.||0.1795|0.0219|0.013
91583322|NCT01765192|183056684|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED|95.0|-0.0185|0.1422||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FVC measurement as the covariate.|ANCOVA|||||0.1422|-0.0185|0.129
91583323|NCT01765192|183056685|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.032|TWO_SIDED|95.0|0.0113|0.2364||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FEF measurement as the covariate.|ANCOVA|||||0.2364|0.0113|0.032
91583324|NCT01765192|183056686|SUPERIORITY_OR_OTHER||LS Mean Difference|7.21|STANDARD_ERROR_OF_MEAN|15.105||0.635||95.0|-23.0531|37.466||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||37.4660|-23.0531|0.635
91777606|NCT03605667|183436474|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.867|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Model based summary statistics were from an analysis of covariance (ANCOVA) with baseline MMSE total score as covariate.||0.5|-0.6|0.8670
91777607|NCT03605667|183436475|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.21||0.195|TWO_SIDED|95.0|-0.8|3.9|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||3.9|-0.8|0.1950
91777608|NCT03605667|183436476|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.31||0.2583|TWO_SIDED|95.0|-1.1|4.1|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||4.1|-1.1|0.2583
91777609|NCT03605667|183436477|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4191|TWO_SIDED|95.0|-0.6|1.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||1.3|-0.6|0.4191
91777610|NCT03605667|183436479|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.224|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||Model based summary statistics are from an ANCOVA with baseline MMSE total score as covariate.||0.3|-1.2|0.2240
91777611|NCT03605667|183436480|SUPERIORITY|||||||0.0161|||||||Fisher Exact|||||||0.0161
91583325|NCT01765192|183056687|SUPERIORITY_OR_OTHER||LS Mean Difference|13.62|STANDARD_ERROR_OF_MEAN|5.206||0.011|TWO_SIDED|95.0|3.1896|24.0553||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||24.0553|3.1896|0.011
91583326|NCT01765192|183056688|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.089||0.025|TWO_SIDED|95.0|-0.385|-0.0271||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptom Score as the covariate.|ANCOVA|||||-0.0271|-0.3850|0.025
91583327|NCT01765192|183056689|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.075||0.217|TWO_SIDED|95.0|-0.2426|0.0563||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate.|ANCOVA|||||0.0563|-0.2426|0.217
91583328|NCT01016977|183056696|SUPERIORITY_OR_OTHER|||||||0.9597||95.0||||Week 1|ANCOVA|||||||0.9597
91583329|NCT01016977|183056696|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 2|ANCOVA|||||||0.5538
91583330|NCT01016977|183056696|SUPERIORITY_OR_OTHER|||||||0.6315||95.0||||Week 4|ANCOVA|||||||0.6315
91583331|NCT01016977|183056696|SUPERIORITY_OR_OTHER|||||||0.5655||95.0||||Week 8|ANCOVA|||||||0.5655
91583332|NCT01016977|183056696|SUPERIORITY_OR_OTHER|||||||0.7917||95.0||||Week 12|ANCOVA|||||||0.7917
91777612|NCT00541658|183436483|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.233|||||TWO_SIDED|95.0|-0.812|0.345|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.345|-0.812|
91646542|NCT02414854|183184908|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.523|||<|0.0001|TWO_SIDED|95.0|0.413|0.662||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.||0.662|0.413|<0.0001
91646543|NCT02414854|183184909|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Least Square (LS) Mean Difference|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.18||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.||0.18|0.08|<0.0001
91646544|NCT02414854|183184909|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.19||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.||0.19|0.08|<0.0001
91646545|NCT02414854|183184910|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|9.41|||<|0.0001|TWO_SIDED|95.0|5.74|13.07||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; \& treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value \& baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error \& handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.||13.07|5.74|<0.0001
91708383|NCT03299101|183309711|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|2.12||0.853|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.||||0.853
91583333|NCT01016977|183056697|SUPERIORITY_OR_OTHER|||||||0.5961||95.0||||Week 1|ANCOVA|||||||0.5961
91583334|NCT01016977|183056697|SUPERIORITY_OR_OTHER|||||||0.2293||95.0||||Week 2|ANCOVA|||||||0.2293
91583335|NCT01016977|183056697|SUPERIORITY_OR_OTHER|||||||0.9852||95.0||||Week 4|ANCOVA|||||||0.9852
91583336|NCT01016977|183056697|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 8|ANCOVA|||||||0.5538
91583337|NCT01016977|183056697|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
91583338|NCT01016977|183056698|SUPERIORITY_OR_OTHER|||||||0.8545||95.0||||Week 1|ANCOVA|||||||0.8545
91583339|NCT01016977|183056698|SUPERIORITY_OR_OTHER|||||||0.2895||95.0||||Week 2|ANCOVA|||||||0.2895
91583340|NCT01016977|183056698|SUPERIORITY_OR_OTHER|||||||0.8234||95.0||||Week 4|ANCOVA|||||||0.8234
91583341|NCT01016977|183056698|SUPERIORITY_OR_OTHER|||||||0.3644||95.0||||Week 8|ANCOVA|||||||0.3644
91583342|NCT01016977|183056698|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
91583343|NCT01016977|183056699|SUPERIORITY_OR_OTHER|||||||0.7546||95.0||||Week 1|ANCOVA|||||||0.7546
91583344|NCT01016977|183056699|SUPERIORITY_OR_OTHER|||||||0.7705||95.0||||Week 2|ANCOVA|||||||0.7705
91583345|NCT01016977|183056699|SUPERIORITY_OR_OTHER|||||||0.0259||95.0||||Week 4|ANCOVA|||||||0.0259
91583346|NCT01016977|183056699|SUPERIORITY_OR_OTHER|||||||0.9252||95.0||||Week 8|ANCOVA|||||||0.9252
91583347|NCT01016977|183056699|SUPERIORITY_OR_OTHER|||||||0.2927||95.0||||Week 12|ANCOVA|||||||0.2927
91583348|NCT01016977|183056700|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Week 1|ANCOVA|||||||0.4010
91583349|NCT01016977|183056700|SUPERIORITY_OR_OTHER|||||||0.0963||95.0||||Week 2|ANCOVA|||||||0.0963
91583350|NCT01016977|183056700|SUPERIORITY_OR_OTHER|||||||0.9291||95.0||||Week 4|ANCOVA|||||||0.9291
91583351|NCT01016977|183056700|SUPERIORITY_OR_OTHER|||||||0.5523||95.0||||Week 8|ANCOVA|||||||0.5523
91583352|NCT01016977|183056700|SUPERIORITY_OR_OTHER|||||||0.2556||95.0||||Week 12|ANCOVA|||||||0.2556
91583353|NCT01016977|183056701|SUPERIORITY_OR_OTHER|||||||0.4037||95.0||||Week 1|ANCOVA|||||||0.4037
91583354|NCT01016977|183056701|SUPERIORITY_OR_OTHER|||||||0.8662||95.0||||Week 2|ANCOVA|||||||0.8662
91583355|NCT01016977|183056701|SUPERIORITY_OR_OTHER|||||||0.5951||95.0||||Week 4|ANCOVA|||||||0.5951
91583356|NCT01016977|183056701|SUPERIORITY_OR_OTHER|||||||0.2349||95.0||||Week 8|ANCOVA|||||||0.2349
91583357|NCT01016977|183056701|SUPERIORITY_OR_OTHER|||||||0.3461||95.0||||Week 12|ANCOVA|||||||0.3461
91583358|NCT01016977|183056702|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||Week 1|ANCOVA|||||||0.7250
91583359|NCT01016977|183056702|SUPERIORITY_OR_OTHER|||||||0.9743||95.0||||Week 2|ANCOVA|||||||0.9743
91583360|NCT01016977|183056702|SUPERIORITY_OR_OTHER|||||||0.9816||95.0||||Week 4|ANCOVA|||||||0.9816
91583361|NCT01016977|183056702|SUPERIORITY_OR_OTHER|||||||0.8809||95.0||||Week 8|ANCOVA|||||||0.8809
91583362|NCT01016977|183056702|SUPERIORITY_OR_OTHER|||||||0.1679||95.0||||Week 12|ANCOVA|||||||0.1679
91583363|NCT01831856|183056821|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5749|TWO_SIDED|95.0|0.71|1.85|||Log Rank|||The primary criterion, time to first Atrial Fibrillation (AF) recurrence or atrial flutter emergence, was described using survival curves according to the Kaplan-Meier method, reporting the first and third quartiles (Q1, Q3), median, and 95% confidence interval. The time to first AF recurrence or atrial flutter emergence was compared between treatment groups using the Log rank test. Hazard ratios and 95% confidence intervals were estimated with the Cox regression model.||1.85|0.71|0.5749
91583364|NCT02996565|183056857|SUPERIORITY||Mean Difference (Net)|-0.76||||0.45|TWO_SIDED|95.0|-2.84|1.33||The threshold for statistical significance was p = 0.05.|planned contrast|The planned contrast compares model-predicted change in SBP from index to 365 days in Telehealth Care vs. Best Practice Clinic-Based Care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.33|-2.84|0.45
91583365|NCT02996565|183056858|SUPERIORITY|Random coefficients model predicted all EHR-documented DBPs from treatment group, days elapsed from index to each DBP (time) and treatment group by time with random clinic and patient intercepts.|Mean Difference (Net)|0.28||||0.64|TWO_SIDED|95.0|-0.95|1.51||The threshold for statistical significance was p\<0.05|planned contrast|The planned contrast compares the model-predicted change in DBP from index to 365 days in Telehealth care vs. index to 365 days in clinic based care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.51|-0.95|0.64
91583366|NCT02996565|183056859|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.53|||<|0.001|TWO_SIDED|95.0|1.27|1.85||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.85|1.27|<0.001
91583367|NCT02996565|183056860|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.25||||0.03|TWO_SIDED|95.0|1.02|1.52||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.52|1.02|0.03
91583368|NCT02996565|183056861|SUPERIORITY|Random coefficients model predicted the likelihood that smoking was current 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.01||||0.73|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of current smoking at 12 months in Telehealth care vs. clinic based care|unadjusted|||1.07|0.95|0.73
91583369|NCT02996565|183056862|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.17||||0.08|TWO_SIDED|95.0|0.98|1.4||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.4|.98|0.08
91583370|NCT02996565|183056863|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.11||||0.18|TWO_SIDED|95.0|0.95|1.29||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.29|0.95|0.18
91583371|NCT02996565|183056864|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.87|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.87|0.77
91583372|NCT02996565|183056865|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.8|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.80|0.32
91583373|NCT02996565|183056866|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.62|TWO_SIDED|95.0|0.76|1.19||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.19|0.76|0.62
91646546|NCT02414854|183184911|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.402|||<|0.0001|TWO_SIDED|95.0|0.307|0.526||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.||0.526|0.307|<0.0001
91646547|NCT02414854|183184912|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.21||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.||0.21|0.09|<0.0001
91646548|NCT02414854|183184913|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.326|||<|0.0001|TWO_SIDED|95.0|0.234|0.454||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.||0.454|0.234|<0.0001
91646549|NCT02414854|183184914|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.32||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.||0.32|0.16|<0.0001
91583374|NCT02996565|183056867|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.91|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.91|0.87
91583375|NCT02996565|183056868|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.51|TWO_SIDED|95.0|0.82|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.82|0.51
91583376|NCT02996565|183056869|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.09||||0.41|TWO_SIDED|95.0|0.87|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.37|0.87|0.41
91583377|NCT02996565|183056870|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.18|TWO_SIDED|95.0|0.77|1.06||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity was helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.06|0.77|0.18
91583378|NCT02996565|183056871|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.92||||0.31|TWO_SIDED|95.0|0.78|1.09||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.09|0.78|0.31
91583379|NCT02996565|183056872|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.56|TWO_SIDED|95.0|0.89|1.22||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.22|0.89|0.56
91583380|NCT02996565|183056873|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.84||||0.08|TWO_SIDED|95.0|0.68|1.03||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.03|0.68|0.08
91583381|NCT02996565|183056874|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.32|TWO_SIDED|95.0|0.73|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|.73|0.32
91583382|NCT02996565|183056875|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.14||||0.09|TWO_SIDED|95.0|0.98|1.33||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.33|0.98|0.09
91583383|NCT02996565|183056876|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.83|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.83|0.77
91583384|NCT02996565|183056877|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.21||||0.09|TWO_SIDED|95.0|0.97|1.5||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.5|.97|0.09
91583385|NCT02996565|183056878|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.64||||0.02|TWO_SIDED|95.0|0.45|0.92||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||0.92|0.45|0.02
91583386|NCT02996565|183056879|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.7||||0.006|TWO_SIDED|95.0|0.55|0.89||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||.89|.55|0.006
91583387|NCT02996565|183056880|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.01|0.60|0.06
91583388|NCT02996565|183056881|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.65|TWO_SIDED|95.0|0.94|1.1||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.10|0.94|0.65
91583389|NCT02996565|183056882|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.83|TWO_SIDED|95.0|0.83|1.25||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.25|0.83|0.83
91708384|NCT03299101|183309711|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|2.16||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.||||0.552
91583390|NCT02996565|183056883|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.41|TWO_SIDED|95.0|0.95|1.13||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.13|0.95|0.41
91583391|NCT02996565|183056884|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.4|TWO_SIDED|95.0|0.94|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.94|0.40
91583392|NCT02996565|183056885|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.01||||0.74|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.07|0.95|0.74
91583393|NCT02996565|183056886|SUPERIORITY|Random coefficients model predicted the likelihood that a new statin was current at 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.05||||0.71|TWO_SIDED|95.0|0.81|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of a new statin medication that is current at 12 months in Telehealth care vs. clinic based care|adjusted for baseline SBP , baseline DBP, baseline age, sex, Asian race|||1.37|0.81|0.71
91583394|NCT01602562|183056889|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|16.11|||||The estimated value reflects the percentage of participants with an HSV infection.|||16.11|0.00|
91583395|NCT01602562|183056889|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|17.65|||||The estimated value reflects the percentage of participants with an HSV infection.|||17.65|0.00|
91583396|NCT04964414|183056908|SUPERIORITY|||||||0.6|||||||Paired t-test|||||||0.6
91583397|NCT04964414|183056909|SUPERIORITY|||||||0.6|||||||Wilcoxon signed-rank|||||||0.6
91583398|NCT04964414|183056910|SUPERIORITY|||||||0.09|||||||Paired t-test|||||||0.09
91583399|NCT04964414|183056915|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
91583400|NCT04964414|183056916|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
91583401|NCT03881553|183056917|OTHER|Non-parametric Friedmans||||||0.081||||||χ2 =5.03|Friedman's|||||||0.081
91583402|NCT03881553|183056917|OTHER|Post hoc: Wilcoxon||||||0.05||||||ON1 compared to OFF1|Wilcoxon (Mann-Whitney)|||||||0.05
91583403|NCT03881553|183056917|OTHER|Post Hoc Wilcoxon||||||0.021||||||ON1 compared to OFF2|Wilcoxon (Mann-Whitney)|||||||0.021
91583404|NCT01313689|183056933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.2677|TWO_SIDED|95.0|0.5|1.24|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.24|0.50|0.2677
91646550|NCT02414854|183184915|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.834||||0.2599|TWO_SIDED|95.0|0.608|1.144||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.||1.144|0.608|0.2599
91583405|NCT01313689|183056933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0837|TWO_SIDED|95.0|0.19|1.53|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.53|0.19|0.0837
91646551|NCT01355523|183184947|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
91646552|NCT01355523|183184947|SUPERIORITY_OR_OTHER||Number need to treat|2.95|||||TWO_SIDED|95.0|1.703|11.024||||||||11.024|1.703|
91583406|NCT01313689|183056934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.003|TWO_SIDED|95.0|0.35|0.87|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.|||0.87|0.35|0.0030
91583407|NCT01313689|183056934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0262|TWO_SIDED|95.0|0.21|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.21|0.0262
91583408|NCT01313689|183056935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.942||||0.0223|TWO_SIDED|95.0|1.166|7.424|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||7.424|1.166|0.0223
91583409|NCT01313689|183056935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|999.999||||0.9985|TWO_SIDED|95.0|0.001|999.999|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||999.999|0.001|0.9985
91583410|NCT01313689|183056936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.366||||0.4159|TWO_SIDED|95.0|0.644|2.899||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement|Regression, Logistic|||||2.899|0.644|0.4159
91583411|NCT01313689|183056936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.8866|TWO_SIDED|95.0|0.076|19.862||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement|Regression, Logistic|||||19.862|0.076|0.8866
91583412|NCT01313689|183056937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.1732|TWO_SIDED|95.0|0.48|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.48|0.1732
91646553|NCT01355523|183184947|SUPERIORITY_OR_OTHER||Relative Risk|0.25|||||TWO_SIDED|95.0|0.076|0.797||||||||0.797|0.076|
91646554|NCT01355523|183184948|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||||||0.125
91646555|NCT01355523|183184949|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Fisher Exact|||||||0.460
91646556|NCT01355523|183184950|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Chi-squared|||||||0.002
91646557|NCT01355523|183184951|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.264
91646558|NCT01355523|183184952|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.351
91646559|NCT01355523|183184953|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.446
91646560|NCT01355523|183184954|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.122
91646561|NCT01355523|183184955|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.907
91521046|NCT01984697|182916885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.7|||<|0.001|TWO_SIDED|95.0|3.08|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.08|<0.001
91521047|NCT01984697|182916886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.5|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.50|<0.001
91521048|NCT01984697|182916886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.99|||<|0.001|TWO_SIDED|95.0|2.55|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.55|<0.001
91521049|NCT01984697|182916886|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|6.31|||<|0.001|TWO_SIDED|95.0|5.36|7.43|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||7.43|5.36|<0.001
91521050|NCT01984697|182916887|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.67|||<|0.001|TWO_SIDED|95.0|1.38|2.03|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.03|1.38|<0.001
91521051|NCT01984697|182916887|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.37|1.99|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.99|1.37|<0.001
91521052|NCT01984697|182916887|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.61|2.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.37|1.61|<0.001
91521053|NCT01984697|182916888|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.36|1.87|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.87|1.36|<0.001
91521054|NCT01984697|182916888|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.51|2.05|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.05|1.51|<0.001
91521055|NCT01984697|182916888|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.08|||<|0.001|TWO_SIDED|95.0|2.64|3.61|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.61|2.64|<0.001
91521056|NCT01984697|182916889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.55|||<|0.001|TWO_SIDED|95.0|2.15|3.01|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.01|2.15|<0.001
91521057|NCT01984697|182916889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.7|||<|0.001|TWO_SIDED|95.0|2.3|3.16|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.16|2.30|<0.001
91583413|NCT01313689|183056937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.8128|TWO_SIDED|95.0|0.46|2.68||P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Log Rank||Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||2.68|0.46|0.8128
91583414|NCT01337115|183056997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.44|STANDARD_ERROR_OF_MEAN|8.4||0.001|TWO_SIDED|95.0|11.55|45.34|||t-test, 2 sided|||Difference between mean VAS pain scores. Power 80%. Null hypothesis states there is no difference between pains scores in both groups||45.34|11.55|0.001
91646562|NCT01355523|183184956|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.555
91646563|NCT01355523|183184957|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.930
91646564|NCT01355523|183184958|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.386
91646565|NCT01355523|183184959|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.241
91646566|NCT01355523|183184960|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.339
91646567|NCT01355523|183184961|SUPERIORITY_OR_OTHER|||||||0.578||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.578
91646568|NCT01355523|183184962|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.000
91646569|NCT02625207|183185001|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.73||||0.1318|TWO_SIDED|90.0|98.55|138.26|||Mixed Models Analysis|||||138.26|98.55|0.1318
91646570|NCT02625207|183185001|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.85||||0.1369|TWO_SIDED|90.0|72.48|101.68|||Mixed Models Analysis|||||101.68|72.48|0.1369
91646571|NCT02625207|183185001|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.38|||<|0.0001|TWO_SIDED|90.0|53.51|75.07|||Mixed Models Analysis|||||75.07|53.51|< 0.0001
91646572|NCT02625207|183185001|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.83||||0.0036|TWO_SIDED|90.0|62.57|87.13|||Mixed Models Analysis|||||87.13|62.57|0.0036
91646573|NCT02625207|183185001|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.99||||0.0038|TWO_SIDED|90.0|62.7|87.31|||Mixed Models Analysis|||||87.31|62.70|0.0038
91646574|NCT02625207|183185002|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.59||||0.0531|TWO_SIDED|90.0|70.33|96.98|||Mixed Models Analysis|||||96.98|70.33|0.0531
91646575|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|137.07||||0.0106|TWO_SIDED|90.0|112.4|167.15|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||167.15|112.40|0.0106
91583415|NCT01337115|183056998|SUPERIORITY_OR_OTHER|||||||0.537||||||The null hypothesis is that there is no difference in patient satisfaction distribution by the three categories used (Bad; Reasonable; Good/Very Good) between groups.|Fisher's exact test|Fisher's Exact test allows to test for the significance of the distribution in the results table with three categories.||||||0.537
91583416|NCT01337115|183056999|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|5.67||0.006|TWO_SIDED|95.0|5.52|28.33|||t-test, 2 sided|||Null hypothesis states that there is no difference between groups. Power 80%||28.33|5.52|0.006
91583417|NCT01337115|183057000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|7.14||0.723|TWO_SIDED|95.0|-16.93|11.83|||t-test, 2 sided|||Null hypothesis states there is no difference between both groups. Power 80% to detect 15% difference in means||11.83|-16.93|0.723
91583418|NCT03386110|183057002|SUPERIORITY||Risk Ratio, log|1.19||||0.08|TWO_SIDED|95.0|-0.15|2.54|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-month follow-up, and controlled for the nesting of participants within couples.||2.54|-0.15|0.08
91583419|NCT03386110|183057002|SUPERIORITY||Risk Ratio, log|0.7||||0.25|TWO_SIDED|95.0|-0.49|1.89|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||1.89|-0.49|0.25
91583420|NCT03386110|183057002|SUPERIORITY||Risk Ratio, log|1.79||||0.007|TWO_SIDED|95.0|0.49|3.09|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||3.09|0.49|0.007
91583421|NCT03386110|183057002|SUPERIORITY||Risk Ratio, log|-0.36||||0.71|TWO_SIDED|95.0|-2.26|1.53|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||1.53|-2.26|0.71
91583422|NCT03386110|183057003|SUPERIORITY||Risk Ratio, log|0.36||||0.36|TWO_SIDED|95.0|-0.65|1.37|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.37|-0.65|0.36
91583423|NCT03386110|183057003|SUPERIORITY||Risk Ratio, log|-0.18||||0.63|TWO_SIDED|95.0|-1.15|0.78|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.78|-1.15|0.63
91583424|NCT03386110|183057003|SUPERIORITY||Risk Ratio, log|-0.54||||0.42|TWO_SIDED|95.0|-1.85|0.77|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.77|-1.85|0.42
91777613|NCT00541658|183436483|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.296|||||TWO_SIDED|95.0|-0.869|0.277|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.277|-0.869|
91777614|NCT00541658|183436484|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265||||0.2955|TWO_SIDED|95.0|-0.763|0.232|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant used.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.232|-0.763|0.2955
91583425|NCT03386110|183057003|SUPERIORITY||Risk Ratio, log|-1.7||||0.02|TWO_SIDED|95.0|-3.14|-0.27|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||-0.27|-3.14|0.02
91646576|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|164.06||||0.0001|TWO_SIDED|90.0|134.54|200.06|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||200.06|134.54|0.0001
91646577|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|198.49|||<|0.0001|TWO_SIDED|90.0|162.77|242.05|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||242.05|162.77|< 0.0001
91583426|NCT03386110|183057004|SUPERIORITY||Risk Ratio, log|0.48||||0.15|TWO_SIDED|95.0|-0.18|1.44|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.44|-0.18|0.15
91583427|NCT03386110|183057004|SUPERIORITY||Risk Ratio, log|0.24||||0.5|TWO_SIDED|95.0|-0.44|0.92|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.92|-0.44|0.50
91583428|NCT03386110|183057004|SUPERIORITY||Risk Ratio, log|-0.02||||0.91|TWO_SIDED|95.0|-0.34|0.31|||Mixed Models Analysis|Three-way interaction model testing whether baseline use moderated the effect of condition on marijuana use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.31|-0.34|0.910
91583429|NCT03386110|183057004|SUPERIORITY||Risk Ratio, log|0.34||||0.11|TWO_SIDED|95.0|-0.07|0.75|||Mixed Models Analysis|||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.75|-0.07|0.11
91583430|NCT02697292|183057005|SUPERIORITY||Odds Ratio (OR)|10.5||||0.044|TWO_SIDED|95.0|1.1|98.9|||t-test, 1 sided|||||98.9|1.1|0.044
91583431|NCT02697292|183057006|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
91583432|NCT03426267|183057009|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91583433|NCT03426267|183057010|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91521058|NCT01984697|182916889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.98|||<|0.001|TWO_SIDED|95.0|4.23|5.86|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.86|4.23|<0.001
91583434|NCT01043393|183057016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.779|||||TWO_SIDED|95.0|0.055|11.126||||||||11.126|0.055|
91583435|NCT02673515|183057094|OTHER|||||||0.797|||||||t-test, 2 sided|||Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Test||||0.797
91583436|NCT01370590|183057107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet was considered equivalent to co-administration of ezetimibe 10 mg and atorvastatin 20 mg, if the two-sided 97.5% expanded confidence intervals of the treatment difference in least squares means for percent change in LDL-C from baseline after 6 weeks of treatment (combination minus co-administration) was contained within -4% and 4% (equivalence margins).|Difference in Least-square Means|-0.2|||||TWO_SIDED|97.5|-1.7|3.3|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.4% and that the standard deviation of the difference is 12.8%.||3.3|-1.7|
91583437|NCT01370590|183057108|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-square means|0.3|||||TWO_SIDED|97.5|-0.8|1.4|||ANCOVA|||||1.4|-0.8|
91646578|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|120.99||||0.1061|TWO_SIDED|90.0|99.65|146.9|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||146.90|99.65|0.1061
91521059|NCT01984697|182916890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
91583438|NCT01370590|183057109|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|0.8|||||TWO_SIDED|97.5|-0.6|2.2|||ANCOVA|||||2.2|-0.6|
91583439|NCT01370590|183057110|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.0|||||TWO_SIDED|97.5|-1.3|1.4|||ANCOVA|||||1.4|-1.3|
91583440|NCT01370590|183057111|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.7|||||TWO_SIDED|97.5|-0.6|1.9|||ANCOVA|||||1.9|-0.6|
91583441|NCT01370590|183057112|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.6|||||TWO_SIDED|97.5|-3.2|6.3|||Constrained Longitudinal Data Analysis|||Analyses were based on log-transformed data.||6.3|-3.2|
91583442|NCT03992846|183057119|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|97.5|1.46|4.49|||Bonferroni-corrected p-value|||||4.49|1.46|<0.001
91583443|NCT03992846|183057119|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|97.5|4.86|15.91|||Bonferroni-corrected p-value|||||15.91|4.86|<0.001
91583444|NCT03992846|183057120|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|1.43||||0.279|TWO_SIDED|97.5|0.83|2.45|||Bonferroni-corrected p-value|||||2.45|0.83|0.279
91583445|NCT03992846|183057120|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|2.01||||0.007|TWO_SIDED|97.5|1.18|3.42|||Bonferroni-corrected p-value|||||3.42|1.18|0.007
91583446|NCT00409773|183057133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-16.5|-9.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-9.8|-16.5|<0.001
91583447|NCT00409773|183057133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-13.6|-6.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.9|-13.6|<0.001
91583448|NCT00409773|183057133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-11.3|-4.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.6|-11.3|<0.001
91583449|NCT00409773|183057134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-9.6|-4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.8|-9.6|<0.001
91583450|NCT00409773|183057134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.8|-2.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.9|-7.8|<0.001
91583451|NCT00409773|183057134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.0|-6.8|<0.001
91583452|NCT00409773|183057135|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.69||95.0|-5.4|3.3|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.3|-5.4|0.690
91583453|NCT00409773|183057135|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.8||||0.2||95.0|-1.6|7.1|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.1|-1.6|0.200
91583454|NCT00409773|183057135|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.4||||0.48||95.0|-4.7|3.9|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.9|-4.7|0.480
91583455|NCT00409773|183057136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.3||0.013||95.0|0.7|6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.0|0.7|0.013
91583456|NCT00409773|183057136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.3||0.378||95.0|-1.5|3.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||3.8|-1.5|0.378
91583457|NCT00409773|183057136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003||95.0|1.3|6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.6|1.3|0.003
91583458|NCT00409773|183057137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-13.3|-7.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-7.3|-13.3|<0.001
91646579|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|272.07|||<|0.0001|TWO_SIDED|90.0|224.08|330.33|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||330.33|224.08|<0.0001
91583459|NCT00409773|183057137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-10.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-10.2|<0.001
91583460|NCT00409773|183057137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.9|-3.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.9|-9.9|<0.001
91583461|NCT00409773|183057138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.6||0.809||95.0|-5.7|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-5.7|0.809
91583462|NCT00409773|183057138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.6||0.217||95.0|-1.9|8.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||8.4|-1.9|0.217
91583463|NCT00409773|183057138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.6||0.796||95.0|-5.8|4.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.4|-5.8|0.796
91583464|NCT00409773|183057139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-12.1|-6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.6|-12.1|<0.001
91583465|NCT00409773|183057139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.1|-2.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.6|-8.1|<0.001
91583466|NCT00409773|183057139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.0|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.0|<0.001
91646580|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|110.22||||0.3081|TWO_SIDED|90.0|94.05|129.18|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||129.18|94.05|0.3081
91646581|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.71||||0.8583|TWO_SIDED|90.0|86.79|119.2|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||119.20|86.79|0.8583
91646582|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|108.52||||0.3913|TWO_SIDED|90.0|92.6|127.17|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||127.17|92.60|0.3913
91646583|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|106.69||||0.4866|TWO_SIDED|90.0|91.36|124.6|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||124.60|91.36|0.4866
91646584|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|119.61||||0.059|TWO_SIDED|90.0|102.42|139.69|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||139.69|102.42|0.0590
91646585|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.7||||0.9816|TWO_SIDED|90.0|80.47|123.53|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||123.53|80.47|0.9816
91646586|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.12||||0.6974|TWO_SIDED|90.0|84.84|130.24|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||130.24|84.84|0.6974
91646587|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.03||||0.9363|TWO_SIDED|90.0|81.54|125.18|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||125.18|81.54|0.9363
91646588|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|96.11||||0.752|TWO_SIDED|90.0|77.94|118.52|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||118.52|77.94|0.7520
91646589|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|100.73||||0.9536|TWO_SIDED|90.0|81.69|124.22|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||124.22|81.69|0.9536
91646590|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.6||||0.8241|TWO_SIDED|90.0|81.28|117.18|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||117.18|81.28|0.8241
91646591|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.5||||0.1261|TWO_SIDED|90.0|98.69|142.28|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||142.28|98.69|0.1261
91646592|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.6||||0.9708|TWO_SIDED|90.0|82.95|119.59|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||119.59|82.95|0.9708
91777615|NCT00541658|183436485|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.131|||||TWO_SIDED|95.0|-0.674|0.412|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.412|-0.674|
91646593|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|84.05||||0.1099|TWO_SIDED|90.0|70.29|100.52|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||100.52|70.29|0.1099
91646594|NCT02625207|183185003|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.21||||0.7913|TWO_SIDED|90.0|81.29|116.25|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||116.25|81.29|0.7913
91646595|NCT02625207|183185004|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.65||||0.1338|TWO_SIDED|90.0|98.47|138.18|||Mixed Models Analysis|||||138.18|98.47|0.1338
91646596|NCT02625207|183185004|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.84||||0.137|TWO_SIDED|90.0|72.46|101.68|||Mixed Models Analysis|||||101.68|72.46|0.1370
91646597|NCT02625207|183185004|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.34|||<|0.0001|TWO_SIDED|90.0|53.47|75.04|||Mixed Models Analysis|||||75.04|53.47|< 0.0001
91646598|NCT02625207|183185004|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.79||||0.0036|TWO_SIDED|90.0|62.53|87.09|||Mixed Models Analysis|||||87.09|62.53|0.0036
91646599|NCT02625207|183185004|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.89||||0.0037|TWO_SIDED|90.0|62.61|87.2|||Mixed Models Analysis|||||87.20|62.61|0.0037
91646600|NCT02625207|183185005|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.42||||0.0507|TWO_SIDED|90.0|70.2|96.77|||Mixed Models Analysis|||||96.77|70.20|0.0507
91646601|NCT02625207|183185006|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.19||||0.1997|TWO_SIDED|90.0|95.26|146.63|||Mixed Models Analysis|||||146.63|95.26|0.1997
91646602|NCT02625207|183185006|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|87.28||||0.2947|TWO_SIDED|90.0|70.34|108.28|||Mixed Models Analysis|||||108.28|70.34|0.2947
91646603|NCT02625207|183185006|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|61.23||||0.0004|TWO_SIDED|90.0|49.35|75.97|||Mixed Models Analysis|||||75.97|49.35|0.0004
91646604|NCT02625207|183185006|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|70.16||||0.0071|TWO_SIDED|90.0|56.81|86.63|||Mixed Models Analysis|||||86.63|56.81|0.0071
91646605|NCT02625207|183185006|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|72.37||||0.0135|TWO_SIDED|90.0|58.6|89.36|||Mixed Models Analysis|||||89.36|58.60|0.0135
91646606|NCT02625207|183185007|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|68.32||||0.0505|TWO_SIDED|90.0|49.81|93.71|||Mixed Models Analysis|||||93.71|49.81|0.0505
91646607|NCT02625207|183185008|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|94.83||||0.6761|TWO_SIDED|90.0|76.7|117.24|||Mixed Models Analysis|||||117.24|76.70|0.6761
91646608|NCT02625207|183185008|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.43||||0.6771||90.0|85.28|130.35|||Mixed Models Analysis|||||130.35|85.28|0.6771
91646609|NCT02625207|183185008|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|75.74||||0.0331|TWO_SIDED|90.0|61.26|93.64|||Mixed Models Analysis|||||93.64|61.26|0.0331
91583467|NCT00409773|183057140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.2||0.042||95.0|0.1|4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.8|0.1|0.042
91583468|NCT00409773|183057140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-0.2|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-0.2|<0.001
91583469|NCT00409773|183057140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.0|4.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.0|-7.0|<0.001
91583470|NCT00409773|183057141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.6|-6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.0|-11.6|<0.001
91583471|NCT00409773|183057141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.2|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.2|<0.001
91583472|NCT00409773|183057141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.7|-3.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.1|-8.7|<0.001
91583473|NCT00409773|183057142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-17.6|-10.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-10.5|-17.6|<0.001
91583474|NCT00409773|183057142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-13.2|-6.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.1|-13.2|<0.001
91583475|NCT00409773|183057142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-12.0|-4.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.9|-12.0|<0.001
91583476|NCT00409773|183057143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-14.0|-8.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.0|-14.0|<0.001
91583477|NCT00409773|183057143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.4|-3.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.3|-9.4|<0.001
91583478|NCT00409773|183057143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-8.7|-2.7|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.7|-8.7|<0.001
91583479|NCT00409773|183057144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.0|-8.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.1|-15.0|<0.001
91646610|NCT02625207|183185008|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.84||||0.0104|TWO_SIDED|90.0|58.38|88.4|||Mixed Models Analysis|||||88.40|58.38|0.0104
91646611|NCT02625207|183185008|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.82||||0.0104|TWO_SIDED|90.0|58.37|88.39|||Mixed Models Analysis|||||88.39|58.37|0.0104
91583480|NCT00409773|183057144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-10.4|-3.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.6|-10.4|<0.001
91583481|NCT00409773|183057144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-11.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-11.2|<0.001
91583482|NCT00409773|183057147|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.9||||0.42||95.0|-11.0|5.0|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||5.0|-11.0|0.420
91583483|NCT00409773|183057147|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.9||||0.555||95.0|-9.5|7.2|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.2|-9.5|0.555
91583484|NCT00409773|183057147|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.3||||0.41||95.0|-5.1|9.6|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||9.6|-5.1|0.410
91583485|NCT01919814|183057156|SUPERIORITY||||||>|0.05||||||Threshold P-Value was 0.05|t-test, 2 sided|||||||>0.05
91583486|NCT02164383|183057159|SUPERIORITY||Mean Difference (Final Values)|1.82||||0.85|TWO_SIDED||||||ANOVA||ANOVA results: F(1,28)=.04, p=.85, partial eta-squared (as a measure of effect size) = .001|||||.85
91583487|NCT01440374|183057161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.202||||0.0315|TWO_SIDED|95.0|0.047|0.868|||Generalized Linear Mixed Models|||||0.868|0.047|0.0315
91583488|NCT03057977|183057223|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.04|0.65|0.86|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~alpha = 0.0496 (resulting from interim analysis) eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.86|0.65|<0.0001
91613903|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.677||||0.0007|TWO_SIDED|95.0|1.243|2.263|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.263|1.243|0.0007
91613904|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.384||||0.0002|TWO_SIDED|95.0|1.166|1.641|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.641|1.166|0.0002
91646612|NCT02625207|183185009|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.62||||0.9713|TWO_SIDED|90.0|83.07|119.45|||Mixed Models Analysis|||||119.45|83.07|0.9713
91646613|NCT02016755|183185052|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||Overall (LOCF)||||0.331
91646614|NCT02016755|183185052|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||Activity (LOCF)||||0.362
91646615|NCT02016755|183185052|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||Emotional (LOCF)||||0.159
91646616|NCT02016755|183185052|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Pain (LOCF)||||0.468
91646617|NCT02016755|183185052|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||Social (LOCF)||||0.197
91646618|NCT02016755|183185052|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Symptom (LOCF)||||0.448
91646619|NCT02016755|183185053|SUPERIORITY|||||||0.939|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.939
91646620|NCT02016755|183185053|SUPERIORITY|||||||0.508|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.508
91646621|NCT02016755|183185053|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.474
91777616|NCT00541658|183436485|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|0.156|||||TWO_SIDED|95.0|-0.382|0.695|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.695|-0.382|
91646622|NCT02016755|183185053|SUPERIORITY|||||||0.361|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.361
91646623|NCT02016755|183185053|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.258
91646624|NCT02016755|183185053|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||Change from baseline at Month 18||||0.059
91646625|NCT02016755|183185053|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.023
91646626|NCT02016755|183185054|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3 (Dorsalis pedis)||||0.655
91646627|NCT02016755|183185054|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Change from Baseline at Month 6 (Dorsalis pedis)||||0.310
91646628|NCT02016755|183185054|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||Change from Baseline at Month 9 (Dorsalis pedis)||||0.348
91646629|NCT02016755|183185054|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Change from Baseline at Month 12 (Dorsalis pedis)||||0.501
91646630|NCT02016755|183185054|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||Change from Baseline at Month 15 (Dorsalis pedis)||||0.536
91646631|NCT02016755|183185054|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change from Baseline at Month 18 (Dorsalis pedis)||||0.140
91646632|NCT02016755|183185054|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Change from Baseline at LOCF (Dorsalis pedis)||||0.018
91646633|NCT02016755|183185054|SUPERIORITY|||||||0.716|||||||t-test, 2 sided|||Change from baseline at Month 3 (Posterior tibial)||||0.716
91646634|NCT02016755|183185054|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||Change from baseline at Month 6 (Posterior tibial)||||0.641
91646635|NCT02016755|183185054|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from baseline at Month 9 (Posterior tibial)||||0.514
91646636|NCT02016755|183185054|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||Change from baseline at Month 12 (Posterior tibial)||||0.808
91646637|NCT02016755|183185054|SUPERIORITY|||||||0.396|||||||t-test, 2 sided|||Change from baseline at Month 15 (Posterior tibial)||||0.396
91646638|NCT02016755|183185054|SUPERIORITY|||||||0.162|||||||t-test, 2 sided|||Change from baseline at Month 18 (Posterior tibial)||||0.162
91646639|NCT02016755|183185054|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||Change from baseline at LOCF (Posterior tibial)||||0.259
91708385|NCT03299101|183309712|SUPERIORITY|||||||0.256||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.||||0.256
91777617|NCT00541658|183436486|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.258|||||TWO_SIDED|95.0|-0.836|0.321|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.321|-0.836|
91777618|NCT00541658|183436486|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.322|||||TWO_SIDED|95.0|-0.9|0.256|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.256|-0.900|
91777619|NCT00541658|183436487|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.154|||||TWO_SIDED|95.0|-1.903|-0.405|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.405|-1.903|
91777620|NCT00541658|183436487|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.044|||||TWO_SIDED|95.0|-1.789|-0.299|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.299|-1.789|
91646640|NCT02016755|183185055|SUPERIORITY|||||||0.671|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.671
91646641|NCT02016755|183185055|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.925
91646642|NCT02016755|183185055|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.514
91646643|NCT02016755|183185055|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.302
91646644|NCT02016755|183185055|SUPERIORITY|||||||0.373|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.373
91646645|NCT02016755|183185055|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.505
91646646|NCT02016755|183185055|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.135
91646647|NCT02016755|183185055|SUPERIORITY|||||||0.175|||||||t-test, 2 sided|||Change from baseline at month 3 (Left)||||0.175
91646648|NCT02016755|183185055|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Change from baseline at month 6 (Left)||||0.393
91646649|NCT02016755|183185055|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||Change from baseline at month 9 (Left)||||0.928
91646650|NCT02016755|183185055|SUPERIORITY|||||||0.429|||||||t-test, 2 sided|||Change from baseline at month 12 (Left)||||0.429
91646651|NCT02016755|183185055|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||Change from baseline at month 15 (Left)||||0.907
91646652|NCT02016755|183185055|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change from baseline at month 18 (Left)||||0.300
91646653|NCT02016755|183185055|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||Change from baseline at LOCF (Left)||||0.214
91708386|NCT03299101|183309712|SUPERIORITY||Mean Difference (Net)|4.69|STANDARD_ERROR_OF_MEAN|2.78||0.091|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.||||0.091
91777621|NCT00541658|183436488|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.059|||||TWO_SIDED|95.0|-1.762|-0.355|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.355|-1.762|
91777622|NCT00541658|183436488|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.922|||||TWO_SIDED|95.0|-1.62|-0.223|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.223|-1.620|
91777623|NCT00541658|183436489|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0524|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0524
91777624|NCT00541658|183436489|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.1207|TWO_SIDED|95.0|0.99|1.15|||Fisher Exact|||||1.15|0.99|0.1207
91777625|NCT00541658|183436490|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.0729|TWO_SIDED|95.0|1.0|1.15|||Fisher Exact|||||1.15|1.00|0.0729
91777626|NCT00541658|183436490|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.06||||0.1639|TWO_SIDED|95.0|0.98|1.14|||Fisher Exact|||||1.14|0.98|0.1639
91777627|NCT00541658|183436491|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0476|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0476
91777628|NCT00541658|183436491|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.12||||0.0014|TWO_SIDED|95.0|1.04|1.2|||ANOVA|||||1.20|1.04|0.0014
91777629|NCT00541658|183436492|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0547|TWO_SIDED|95.0|1.0|1.16|||ANOVA|||||1.16|1.00|0.0547
91777630|NCT00541658|183436492|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.1||||0.0066|TWO_SIDED|95.0|1.03|1.18|||ANOVA|||||1.18|1.03|0.0066
91777631|NCT00541658|183436493|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.135|||||TWO_SIDED|95.0|-0.504|0.234|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.234|-0.504|
91583489|NCT03057977|183057224|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.04|0.58|0.85|||Joint frailty model||HR vs placebo of recurrent HFF|"Model accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.85|0.58|0.0003
91646654|NCT02016755|183185056|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.655
91646655|NCT02016755|183185056|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.226
91777632|NCT00541658|183436493|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.072|||||TWO_SIDED|95.0|-0.437|0.294|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.294|-0.437|
91777633|NCT00541658|183436494|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.321|||||TWO_SIDED|95.0|-0.724|0.082|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.082|-0.724|
91777634|NCT00541658|183436494|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.692|0.112|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.112|-0.692|
91777635|NCT00541658|183436495|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.288|||||TWO_SIDED|95.0|-0.682|0.106|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.106|-0.682|
91777636|NCT00541658|183436495|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.681|0.101|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.101|-0.681|
91777637|NCT00541658|183436496|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.644|||||TWO_SIDED|95.0|-1.179|-0.11|||ANOVA|||||-0.110|-1.179|
91777638|NCT00541658|183436496|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.587|||||TWO_SIDED|95.0|-1.116|-0.059|||ANOVA|||||-0.059|-1.116|
91777639|NCT00541658|183436497|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.03|-0.014|||ANOVA|||||-0.014|-1.030|
91777640|NCT00541658|183436497|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.468|||||TWO_SIDED|95.0|-0.973|0.037|||ANOVA|||||0.037|-0.973|
91646656|NCT02016755|183185056|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.380
91646657|NCT02016755|183185056|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.187
91646658|NCT02016755|183185056|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.203
91646659|NCT02016755|183185056|SUPERIORITY|||||||0.074|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.074
91646660|NCT02016755|183185056|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.038
91583490|NCT03057977|183057225|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.733|||<|0.0001|TWO_SIDED|99.9|0.669|2.796|||Random intercept random coef. model||Empa vs Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with the same factors used for the primary endpoint (age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment) and additional factors time, treatment-by-time interaction, and baseline eGFR (CKD-EPI)cr-by-time interaction. Only on-treatment data from treated patients were used.~alpha=0.001"||2.796|0.669|<0.0001
91583491|NCT03057977|183057226|OTHER||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.77|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs. Placebo|||0.77|0.32|0.0019
91646661|NCT02016755|183185057|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.246
91646662|NCT02016755|183185057|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.474
91646663|NCT02016755|183185057|SUPERIORITY|||||||0.395|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.395
91646664|NCT02016755|183185057|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.220
91646665|NCT02016755|183185057|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.454
91521060|NCT01984697|182916890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
91521061|NCT01984697|182916890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
91583492|NCT03057977|183057227|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs Placebo|||0.81|0.59|<0.0001
91583493|NCT03057977|183057228|OTHER||Hazard Ratio (HR)|0.92||||0.4133|TWO_SIDED|95.0|0.75|1.12|||Regression, Cox|Model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. Placebo|||1.12|0.75|0.4133
91583494|NCT03057977|183057229|OTHER||Hazard Ratio (HR)|0.92||||0.3536|TWO_SIDED|95.0|0.77|1.1|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.10|0.77|0.3536
91646666|NCT02016755|183185057|SUPERIORITY|||||||0.167|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.167
91646667|NCT02016755|183185057|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.015
91646668|NCT04440163|183185089|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (\>) minus (-)10 percent (%), the non-inferiority was concluded.|Difference in percentage of participants|2.5|||||TWO_SIDED|95.0|-0.2|6.0|||Based on Miettinen and Nurminen method.|||MenA||6.0|-0.2|
91646669|NCT04440163|183185089|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|41.0|||||TWO_SIDED|95.0|34.4|47.5||||||MenC||47.5|34.4|
91777641|NCT00541658|183436498|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.731|0.201|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.201|-0.731|
91777642|NCT00541658|183436498|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.588|0.336|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.336|-0.588|
91777643|NCT00541658|183436499|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.328|||||TWO_SIDED|95.0|-0.811|0.156|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.156|-0.811|
91777644|NCT00541658|183436499|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.563|||||TWO_SIDED|95.0|-1.045|-0.08|||ANOVA|Fixed effects for treatment, pooled center, anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.080|-1.045|
91777645|NCT00541658|183436500|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.327|||||TWO_SIDED|95.0|-0.793|0.138|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.138|-0.793|
91777646|NCT00541658|183436500|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.537|||||TWO_SIDED|95.0|-1.0|-0.074|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.074|-1.000|
91777647|NCT00541658|183436501|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.578|||||TWO_SIDED|95.0|-1.189|0.032|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.032|-1.189|
91777648|NCT00541658|183436501|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.799|||||TWO_SIDED|95.0|-1.403|-0.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.194|-1.403|
91777649|NCT00541658|183436502|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.555|||||TWO_SIDED|95.0|-1.128|0.018|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.018|-1.128|
91777650|NCT00541658|183436502|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.616|||||TWO_SIDED|95.0|-1.185|-0.046|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.046|-1.185|
91777651|NCT00541658|183436503|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.249|||||TWO_SIDED|95.0|-0.86|0.363|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.363|-0.860|
91777652|NCT00541658|183436503|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.871|0.342|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.342|-0.871|
91777653|NCT00541658|183436504|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.557|||||TWO_SIDED|95.0|-1.185|0.071|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.071|-1.185|
91521062|NCT01984697|182916891|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
91521063|NCT01984697|182916891|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
91521064|NCT01984697|182916891|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
91521065|NCT01984697|182916892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
91521066|NCT01984697|182916892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
91583495|NCT03057977|183057230|OTHER||Hazard Ratio (HR)|0.86||||0.3576|TWO_SIDED|95.0|0.62|1.19|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.19|0.62|0.3576
91583496|NCT03057977|183057231|OTHER||Difference of adjusted means|2.06|STANDARD_ERROR_OF_MEAN|0.97||0.034|TWO_SIDED|95.0|0.16|3.96|||Mixed Model|Mixed model for repeated measures (MMRM)|Comparison vs. placebo|Mixed model with age, baseline eGFR (CKD-EPI) as linear covariate(s) and region, baseline diabetes status, sex, baseline LVEF, week reachable, treatment by visit interaction, baseline KCCQ - Clinical Summary Score by Visit interaction as fixed effects. An unstructured covariance structure has been used.||3.96|0.16|0.0340
91583497|NCT03057977|183057232|OTHER||Hazard Ratio (HR)|0.85||||0.0065|TWO_SIDED|95.0|0.75|0.95|||Joint frailty model||Comparison vs. placebo|Joint frailty model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline diabetes status and baseline LVEF. Model accounts for dependence between recurrent all-cause hospitalizations and all-cause mortality.||0.95|0.75|0.0065
91583498|NCT01350336|183057238|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 2 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.038|||||TWO_SIDED|95.0|-0.1251|0.0497||||||Comparison of Years 1 and 2||0.0497|-0.1251|
91583499|NCT01350336|183057238|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 3 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0325|||||TWO_SIDED|95.0|-0.1197|0.0565||||||Comparison of Years 1 and 3||0.0565|-0.1197|
91777654|NCT00541658|183436504|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.149|0.105|||ANOVA||LS Mean Difference is 5 mg daily minus weekly treatment.|||0.105|-1.149|
91777655|NCT00541658|183436505|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.546|||||TWO_SIDED|95.0|-1.17|0.078|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.078|-1.170|
91777656|NCT00541658|183436505|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.579|||||TWO_SIDED|95.0|-1.199|0.042|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.042|-1.199|
91777657|NCT00541658|183436506|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.095|||||TWO_SIDED|95.0|-1.861|-0.329|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.329|-1.861|
91777658|NCT00541658|183436506|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.19|||||TWO_SIDED|95.0|-1.948|-0.432|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.432|-1.948|
91777659|NCT00541658|183436507|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.919|||||TWO_SIDED|95.0|-1.655|-0.184|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.184|-1.655|
91777660|NCT00541658|183436507|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.056|||||TWO_SIDED|95.0|-1.787|-0.326|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.326|-1.787|
91777661|NCT00541658|183436508|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.771|||||TWO_SIDED|95.0|-0.885|8.427|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.427|-0.885|
91790181|NCT02660138|183459523|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.63||||0.0012|TWO_SIDED|95.0|1.68|7.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||7.86|1.68|0.0012
91583500|NCT01350336|183057238|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 4 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0566|||||TWO_SIDED|95.0|-0.1444|0.0329||||||Comparison of Years 1 and 4||0.0329|-0.1444|
91521067|NCT01984697|182916892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
91646670|NCT04440163|183185089|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|24.3|||||TWO_SIDED|95.0|18.8|30.4||||||MenW||30.4|18.8|
91777662|NCT00541658|183436508|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.826|||||TWO_SIDED|95.0|-1.819|7.471|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.471|-1.819|
91777663|NCT00541658|183436509|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.63|||||TWO_SIDED|95.0|-2.171|7.431|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.431|-2.171|
91777664|NCT00541658|183436509|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.617|||||TWO_SIDED|95.0|-0.152|9.386|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.386|-0.152|
91777665|NCT00541658|183436510|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.04|||||TWO_SIDED|95.0|0.091|9.989|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.989|0.091|
91521068|NCT01984697|182916893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.8|-1.7|<0.001
91521069|NCT01984697|182916893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
91521070|NCT01984697|182916893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
91521071|NCT01984697|182916894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
91521072|NCT01984697|182916894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.0|<0.001
91521073|NCT01984697|182916894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.1|<0.001
91521074|NCT01984697|182916895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
91521075|NCT01984697|182916895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
91521076|NCT01984697|182916895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|2.1|||<|0.001|TWO_SIDED|95.0|0.7|4.6|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.6|0.7|<0.001
91777666|NCT00541658|183436510|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.64|||||TWO_SIDED|95.0|-0.293|9.574|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.574|-0.293|
91777667|NCT00541658|183436511|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.372|||||TWO_SIDED|95.0|1.329|11.414|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.414|1.329|
91777668|NCT00541658|183436511|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.403|||||TWO_SIDED|95.0|-0.619|9.425|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.425|-0.619|
91777669|NCT00541658|183436512|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.739|||||TWO_SIDED|95.0|-0.793|10.271|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.271|-0.793|
91777670|NCT00541658|183436512|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.999|||||TWO_SIDED|95.0|-1.518|9.515|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.515|-1.518|
91777671|NCT00541658|183436513|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.817|||||TWO_SIDED|95.0|-0.693|10.327|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.327|-0.693|
91777672|NCT00541658|183436513|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.192|||||TWO_SIDED|95.0|-2.295|8.68|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.680|-2.295|
91521077|NCT01984697|182916896|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
91521078|NCT01984697|182916896|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
91521079|NCT01984697|182916896|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
91521080|NCT01984697|182916897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
91521081|NCT01984697|182916897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
91521082|NCT01984697|182916897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.1|<0.001
91583501|NCT01350336|183057238|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 5 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0765|||||TWO_SIDED|95.0|-0.1661|0.013||||||Comparison of Years 1 and 5||0.0130|-0.1661|
91583502|NCT04234425|183057251|OTHER|paired t test|Mean Difference (Final Values)|2.702|STANDARD_DEVIATION|5.36||0.017|TWO_SIDED||||||t-test, 2 sided|||||||.017
91583503|NCT04234425|183057252|OTHER|paired t test|Mean Difference (Final Values)|4.2|STANDARD_DEVIATION|7.06||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.08
91583504|NCT04234425|183057253|OTHER|paired t test|Mean Difference (Final Values)|20.47|STANDARD_DEVIATION|7.33||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
91583505|NCT00876928|183057254|SUPERIORITY_OR_OTHER||Percent of patients developing diabetes|10.0||||0.61|TWO_SIDED|95.0|8.0|12.0||A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index|Chi-squared||Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters|Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.||12|8|0.61
91583506|NCT00876928|183057255|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||ANOVA|||The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.||||0.39
91583507|NCT02795429|183057261|SUPERIORITY||Odds Ratio (OR)|0.561|||||||||||Bayesian Logistic Regression Model||Posterior probability that the odds ratio (ORRspartalizumab +capmatinib to ORRspartalizumab) was ≥ 1|||||
91583508|NCT02079610|183057289|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|3.93|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91777673|NCT00541658|183436514|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.45|||||TWO_SIDED|95.0|-0.26|9.16|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.160|-0.260|
91583509|NCT02079610|183057290|SUPERIORITY||Mean Difference (Final Values)|8.2|STANDARD_DEVIATION|5.2||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
91583510|NCT02079610|183057291|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|3.5||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
91583511|NCT03645057|183057301|SUPERIORITY|||||||0.433|||||||Wilcoxon rank sum test|||||||0.433
91583512|NCT03645057|183057302|SUPERIORITY|||||||0.836|||||||Wilcoxon rank sum test|||||||0.836
91583513|NCT03645057|183057303|SUPERIORITY|||||||0.073|||||||Wilcoxon rank sum test|||||||0.073
91583514|NCT03645057|183057304|SUPERIORITY|||||||0.989|||||||Wilcoxon rank sum test|||||||0.989
91583515|NCT03645057|183057305|SUPERIORITY|||||||0.565|||||||Wilcoxon rank sum test|||||||0.565
91583516|NCT03645057|183057306|SUPERIORITY|||||||0.479|||||||Wilcoxon rank sum test|||||||0.479
91583517|NCT03645057|183057307|SUPERIORITY|||||||0.577|||||||Wilcoxon rank sum test|||||||0.577
91583518|NCT03645057|183057308|SUPERIORITY|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||||||0.439
91583519|NCT03645057|183057309|SUPERIORITY|||||||0.242|||||||Wilcoxon rank sum test|||||||0.242
91583520|NCT01171807|183057330|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91583521|NCT03907410|183057393|SUPERIORITY||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|2.0|28.0||||||Multivariate comparison of Experiment phase adherence (Months 1-3) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||28|2|
91646671|NCT04440163|183185089|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|23.8|||||TWO_SIDED|95.0|18.0|30.1||||||MenY||30.1|18.0|
91583522|NCT03907410|183057393|SUPERIORITY||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-20.0|7.0||||||Multivariate comparison of Observation phase adherence (Months 4-6) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||7|-20|
91583523|NCT04776148|183057398|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).|Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|95.0|0.56|0.85||One-sided p-value based on log-rank test stratified by presence of liver metastasis|Log Rank|||||0.85|0.56|0.0003
91583524|NCT04776148|183057399|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.15||||0.7421|TWO_SIDED|85.0|0.75|1.77||One-sided p-value based on log-rank test.|Log Rank|||||1.77|0.75|0.7421
91583525|NCT04776148|183057400|OTHER||Difference in Percentage vs. SOC|8.7|||<|0.0001|TWO_SIDED|95.0|4.7|13.5|||Chi-squared||Based on Miettinen \& Nurminen method stratified by presence of liver metastasis|||13.5|4.7|<0.0001
91583526|NCT04776148|183057401|OTHER||Difference in Percentage vs. SOC|3.3||||0.2456|TWO_SIDED|95.0|-7.7|14.3|||Chi-squared||Based on Miettinen \& Nurminen method.|||14.3|-7.7|0.2456
91583527|NCT04776148|183057408|OTHER||Difference in least squares means|2.71||||0.1553|TWO_SIDED|95.0|-1.03|6.46||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||6.46|-1.03|0.1553
91583528|NCT04776148|183057409|OTHER||Difference in LS means|1.16||||0.4967|TWO_SIDED|95.0|-2.19|4.51||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||4.51|-2.19|0.4967
91583529|NCT04776148|183057410|OTHER||Difference in LS means|3.36||||0.2271|TWO_SIDED|95.0|-2.1|8.82||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||8.82|-2.10|0.2271
91583530|NCT04776148|183057411|OTHER||Difference in LS means|-5.46||||0.0264|TWO_SIDED|95.0|-10.27|-0.65||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||-0.65|-10.27|0.0264
91583531|NCT04776148|183057412|OTHER||Hazard Ratio (HR)|0.91||||0.4338|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.14|0.73|0.4338
91583532|NCT04776148|183057413|OTHER||Hazard Ratio (HR)|1.1||||0.4316|TWO_SIDED|95.0|0.87|1.38||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.38|0.87|0.4316
91583533|NCT04776148|183057414|OTHER||Hazard Ratio (HR)|1.06||||0.5587|TWO_SIDED|95.0|0.85|1.32|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.32|0.85|0.5587
91583534|NCT04776148|183057415|OTHER||Hazard Ratio (HR)|0.95||||0.6794|TWO_SIDED|95.0|0.73|1.23||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.23|0.73|0.6794
91583535|NCT04776148|183057416|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0379|TWO_SIDED|95.0|0.68|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).||1.02|0.68|0.0379
91583536|NCT04776148|183057417|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3574|TWO_SIDED|95.0|0.6|1.42|||Log Rank|One-sided p-value based on log-rank test.|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.||1.42|0.60|0.3574
91583537|NCT00757588|183057420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.59|-0.24||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-0.24|-0.59|<0.0001
91583538|NCT00757588|183057421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3829.8|STANDARD_ERROR_OF_MEAN|1165.99||0.0011|TWO_SIDED|95.0|-6122.4|-1537.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1537.1|-6122.4|0.0011
91583539|NCT00757588|183057422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|7.24||0.0016|TWO_SIDED|95.0|-37.2|-8.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-8.7|-37.2|0.0016
91583540|NCT00757588|183057423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|STANDARD_ERROR_OF_MEAN|4.732||0.3958|TWO_SIDED|95.0|-13.32|5.28||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||5.28|-13.32|0.3958
91583541|NCT00757588|183057425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-5.6|-1.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1.1|-5.6|
91646672|NCT04440163|183185090|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-6.5|0.5||||||MenA||0.5|-6.5|
91646673|NCT04440163|183185090|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.6|3.3||||||MenC||3.3|-4.6|
91646674|NCT04440163|183185090|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|-2.2|4.3||||||MenW||4.3|-2.2|
91646675|NCT04440163|183185090|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.7|||||TWO_SIDED|95.0|-4.6|3.8||||||MenY||3.8|-4.6|
91777674|NCT00541658|183436514|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.723|||||TWO_SIDED|95.0|-0.975|8.421|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.421|-0.975|
91583542|NCT02563522|183057434|OTHER||Mean Difference (Final Values)|18.7||||0.3455|TWO_SIDED|95.0|-12.37|45.81|||Fisher Exact|No imputation was performed for subjects with missing response data||The statistical hypotheses were H0: Pt = Pc versus Ha: Pt ≠ Pc, where Pt and Pc are the proportions of subjects with a confirmed target would closure by the 4-month follow-up for Active (Engensis) and Control (Placebo) groups, respectively. The hypothesis testing was a two-sided alpha of 0.05||45.81|-12.37|0.3455
91583543|NCT01052103|183057435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.732||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.732
91583544|NCT01052103|183057436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.846
91583545|NCT01052103|183057437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.201||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.201
91646676|NCT04440163|183185091|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|9.6|||||TWO_SIDED|95.0|4.2|15.2||||||||15.2|4.2|
91777675|NCT00541658|183436515|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.798|||||TWO_SIDED|95.0|-0.195|9.79|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.790|-0.195|
91646677|NCT04440163|183185092|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|4.0|||||TWO_SIDED|95.0|-0.7|8.9||||||A22||8.9|-0.7|
91646678|NCT04440163|183185092|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-1.0|4.3||||||A56||4.3|-1.0|
91583546|NCT01052103|183057438|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.136||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.136
91583547|NCT01052103|183057439|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.5|STANDARD_ERROR_OF_MEAN|2.4||0.739||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.739
91583548|NCT01052103|183057440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.19||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.190
91646679|NCT04440163|183185092|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|5.2|16.6||||||B24||16.6|5.2|
91646680|NCT04440163|183185092|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage|7.3|||||TWO_SIDED|95.0|2.9|11.9||||||B44||11.9|2.9|
91777676|NCT00541658|183436515|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.972|||||TWO_SIDED|95.0|0.02|9.924|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.924|0.020|
91583549|NCT01052103|183057441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.702||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.702
91583550|NCT01052103|183057442|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.851||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.851
91583551|NCT01052103|183057446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0||||0.999|TWO_SIDED|95.0|-4.3|4.3||P-value is for standing systolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||4.3|-4.3|0.999
91583552|NCT01052103|183057446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.8||||0.009|TWO_SIDED|95.0|1.0|6.7||P-value is for standing diastolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||6.7|1.0|0.009
91583553|NCT01052103|183057447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5||||0.818|TWO_SIDED|95.0|-5.0|3.9|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||3.9|-5.0|0.818
91583554|NCT01052103|183057448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.44||||0.571|TWO_SIDED|95.0|-1.98|1.1|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||1.10|-1.98|0.571
91583555|NCT01052103|183057453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.682||95.0||||P-value is for treatment-emergent suicidal ideation.|Fisher Exact|||||||0.682
91583556|NCT01052103|183057454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.7||0.727||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.727
91777677|NCT00541658|183436516|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.775|||||TWO_SIDED|95.0|-0.514|10.065|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.065|-0.514|
91777678|NCT00541658|183436516|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.638||||||95.0|0.356|10.92|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.920|0.356|
91646681|NCT04440163|183185124|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.7|||||TWO_SIDED|95.0|-1.0|5.3||||||MenA||5.3|-1.0|
91583557|NCT01052103|183057458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.7|STANDARD_ERROR_OF_MEAN|3.4||0.305||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.305
91583558|NCT01052103|183057459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.42||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.420
91583559|NCT00666679|183057468|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||0.033||95.0|0.0|0.09|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.09|0.00|0.033
91583560|NCT00666679|183057469|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.15||||0.005||95.0|-0.26|-0.05|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.05|-0.26|0.005
91583561|NCT00666679|183057470|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.09||||0.015||95.0|-0.17|-0.02|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.02|-0.17|0.015
91583562|NCT00666679|183057471|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.6||||0.073||95.0|-1.26|0.06|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.06|-1.26|0.073
91777679|NCT00541658|183436517|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.552|||||TWO_SIDED|95.0|1.162|11.942|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.942|1.162|
91777680|NCT00541658|183436517|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.531|||||TWO_SIDED|95.0|0.164|10.897|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.897|0.164|
91777681|NCT00541658|183436518|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.83|||||TWO_SIDED|95.0|1.175|14.485|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.485|1.175|
91777682|NCT00541658|183436518|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|8.383|||||TWO_SIDED|95.0|1.757|15.01|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||15.010|1.757|
91583563|NCT00666679|183057472|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|6.08||||0.004||95.0|1.94|10.23|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|Least-Squares Means for average percentage of days are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|||10.23|1.94|0.004
91583564|NCT00666679|183057473|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-5.43|||<=|0.001||95.0|-8.67|-2.19|||ANCOVA|Model with terms for patient, treatment and period.|Least-Squares Means for percentage of days are derived from ANCOVA model with terms for patient, treatment and period.|||-2.19|-8.67|<=0.001
91777683|NCT00541658|183436519|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.802|||||TWO_SIDED|95.0|1.385|14.22|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.220|1.385|
91777684|NCT00541658|183436519|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.301|||||TWO_SIDED|95.0|0.911|13.69|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||13.690|0.911|
91777685|NCT00541658|183436520|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.755|||||TWO_SIDED|95.0|-1.145|4.655|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.655|-1.145|
91777686|NCT00541658|183436520|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.805|||||TWO_SIDED|95.0|-1.087|4.698|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.698|-1.087|
91777687|NCT00541658|183436521|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.407|||||TWO_SIDED|95.0|-0.502|5.316|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.316|-0.502|
91777688|NCT00541658|183436521|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.309|||||TWO_SIDED|95.0|-1.576|4.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.194|-1.576|
91777689|NCT00541658|183436522|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.555|||||TWO_SIDED|95.0|-1.617|4.727|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.727|-1.617|
91583565|NCT00666679|183057474|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.07||||0.013||95.0|-0.12|-0.01|||Mixed Models Analysis|Model with fixed effects for treatment, period and baseline covariate.|Least-Squares Means for change from baseline are derived from mixed model with terms for treatment, period and baseline covariate.|||-0.01|-0.12|0.013
91583566|NCT00666679|183057475|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||0.002||95.0|0.03|0.13|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.13|0.03|0.002
91583567|NCT04874415|183057476|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-6.2|5.3|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||5.3|-6.2|
91583568|NCT04874415|183057476|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-9.4|4.6|||||Fixed step count is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||4.6|-9.4|
91583569|NCT04874415|183057476|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-11.0|3.1|||||Loss framed incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.1|-11|
91583570|NCT04874415|183057476|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|4.4|||||TWO_SIDED|95.0|-1.0|9.8|||||Daily step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||9.8|-1.0|
91583571|NCT04874415|183057477|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-686.0|||||TWO_SIDED|95.0|-2997.0|1626.0|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||1626|-2997|
91583572|NCT04874415|183057477|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-2340.0|||||TWO_SIDED|95.0|-4794.0|115.0|||||Fixed step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||115|-4794|
91583573|NCT04874415|183057477|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-1293.0|||||TWO_SIDED|95.0|-3477.0|890.0|||||||Loss framed incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|890|-3477|
91583574|NCT04874415|183057477|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-135.0|||||TWO_SIDED|95.0|-2424.0|2153.0|||||Daily step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2153|-2424|
91583575|NCT04874415|183057478|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.006|||||TWO_SIDED|95.0|-0.05|0.04|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.04|-0.05|
91583576|NCT04874415|183057478|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.07|0.02|||||Fixed step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.02|-0.07|
91583577|NCT04874415|183057478|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.02|0.06|||||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|0.06|-0.02|
91583578|NCT04874415|183057478|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.0006|||||TWO_SIDED|95.0|-0.04|0.04|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.04|-0.04|
91583579|NCT04874415|183057479|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|-0.006|||||TWO_SIDED|95.0|-10.3|10.3|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||10.3|-10.3|
91583580|NCT04874415|183057479|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|0.00001|||||TWO_SIDED|95.0|-0.03|0.03|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|
91583581|NCT04874415|183057479|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-12.7|12.7|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||12.7|-12.7|
91583582|NCT04874415|183057479|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|-0.00002|||||TWO_SIDED|95.0|-0.03|0.03|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|
91583583|NCT04874415|183057480|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.00003|||||TWO_SIDED|95.0|-2311.0|2311.0|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2311|-2311|
91583584|NCT04874415|183057480|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.0000004|||||TWO_SIDED|95.0|-27.9|27.9|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||27.9|-27.9|
91583585|NCT04874415|183057480|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.005|||||TWO_SIDED|95.0|-6.9|6.8|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||6.8|-6.9|
91583586|NCT04874415|183057480|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-126.0|125.0|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||125|-126|
91583587|NCT04874415|183057481|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-3.9|3.9|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.9|-3.9|
91583588|NCT04874415|183057481|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-2.6|2.6|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2.6|-2.6|
91583589|NCT04874415|183057481|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.00001|||||TWO_SIDED|95.0|-0.02|0.02|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.02|-0.02|
91583590|NCT04874415|183057481|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-22.8|22.8|||||Daily Step Count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||22.8|-22.8|
91583591|NCT04874415|183057482|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-38.3|38.2|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||38.2|-38.3|
91583592|NCT04874415|183057482|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.0001|||||TWO_SIDED|95.0|-0.3|0.3|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.3|-0.3|
91583593|NCT04874415|183057482|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.0006|||||TWO_SIDED|95.0|-0.8|0.8|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.8|-0.8|
91583594|NCT04874415|183057482|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.0001|||||TWO_SIDED|95.0|-0.4|0.4|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.4|-0.4|
91583595|NCT04874415|183057483|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-31.4|31.5|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||31.5|-31.4|
91583596|NCT04874415|183057483|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-44.3|44.5|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||44.5|-44.3|
91583597|NCT04874415|183057483|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-2.7|14.2|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||14.2|-2.7|
91583598|NCT04874415|183057483|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-13.3|2.4|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2.4|-13.3|
91583599|NCT04874415|183057484|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-3.1|3.1|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.1|-3.1|
91583600|NCT04874415|183057484|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.0003|||||TWO_SIDED|95.0|-2.3|2.3|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2.3|-2.3|
91583601|NCT04874415|183057484|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|0.003|||||TWO_SIDED|95.0|-3.4|3.4|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.4|-3.4|
91646682|NCT04440163|183185124|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.5|||||TWO_SIDED|95.0|3.0|17.9||||||MenC||17.9|3.0|
91708387|NCT03299101|183309712|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.69||0.066|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.||||0.066
91777690|NCT00541658|183436522|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.612|||||TWO_SIDED|95.0|-1.556|4.779|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.779|-1.556|
91777691|NCT00541658|183436523|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.434|||||TWO_SIDED|95.0|-1.652|4.521|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.521|-1.652|
91777692|NCT00541658|183436523|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.462|||||TWO_SIDED|95.0|-1.611|4.535|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.535|-1.611|
91777693|NCT00541658|183436524|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.749|||||TWO_SIDED|95.0|-0.938|6.436|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||6.436|-0.938|
91777694|NCT00541658|183436524|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.416|||||TWO_SIDED|95.0|-0.255|7.087|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus daily treatment.|||7.087|-0.255|
91646683|NCT04440163|183185124|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|6.3|||||TWO_SIDED|95.0|-0.1|13.1||||||MenW||13.1|-0.1|
91583602|NCT04874415|183057484|SUPERIORITY|Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.0005|||||TWO_SIDED|95.0|-0.5|0.5|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.5|-0.5|
91583603|NCT04874415|183057485|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|0.00000001|||||TWO_SIDED|95.0|-0.00002|0.00002|||||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.00002|-0.00002|
91583604|NCT04874415|183057485|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|-0.00002|||||TWO_SIDED|95.0|-0.03|0.03|||||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|
91583605|NCT04874415|183057485|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).)|Mean Difference (Final Values)|0.00002|||||TWO_SIDED|95.0|-0.03|0.03|||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|
91583606|NCT04874415|183057485|SUPERIORITY|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Mean Difference (Final Values)|-0.000003|||||TWO_SIDED|95.0|-0.004|0.004|||||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.004|-0.004|
91583607|NCT00701220|183057489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||The data were analyzed using analysis of variance for repeated measures with two groups. The repeated measure was the proportion of circulating blood cells that were positive for aldehyde dehydrogenase using the commercially available Aldofluor assay. The two groups were those with ischemic and non-ischemic cardiomyopathy. This analysis permitted both intergroup and intragroup analysis of the change in aldehyde dehydrogenase positive cells.||||<0.05
91583608|NCT00069108|183057499|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|Hazard Ratio (HR)|1.03||||0.00584|TWO_SIDED|95.0|0.87|1.24|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.24|0.87|0.00584
91583609|NCT00069108|183057500|NON_INFERIORITY_OR_EQUIVALENCE|While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|0.93||||0.00223|TWO_SIDED|95.0|0.74|1.17|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.17|0.74|0.00223
91583610|NCT00069108|183057501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||||1.37|0.91|
91583611|NCT00069108|183057502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||||1.47|0.95|
91583612|NCT00069108|183057503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4028|TWO_SIDED|95.0|0.79|1.77||p-value is for difference between response rates.|Chi-squared|||||1.77|0.79|0.4028
91583613|NCT00069108|183057504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.2911|TWO_SIDED|95.0|0.81|2.01||p-value is for difference between response rates.|Chi-squared|||||2.01|0.81|0.2911
91583614|NCT00069108|183057505|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||||1.23|0.87|
91583615|NCT00069108|183057507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.79|1.68||||||||1.68|0.79|
91583616|NCT00069108|183057508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.81|1.12||||||||1.12|0.81|
91583617|NCT01616056|183057515|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91583618|NCT01616056|183057517|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91583619|NCT01616056|183057519|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91583620|NCT01616056|183057522|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91583621|NCT03339570|183057524|SUPERIORITY||Mean Difference (Final Values)|18.3|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||Student's t test was used if they were variables adjusted to a normal distribution, or the Mann-Whitney U test if they were non-normal variables.||||<0.01
91583622|NCT01718353|183057586|OTHER|||||||0.02|||||||ANOVA|||%ARNL change from baseline at Cycle 1 Day 8 in participants with ≥50% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥50% decrease in PSA at Cycle 4||||0.02
91583623|NCT01718353|183057594|OTHER|||||||0.0927|||||||ANOVA|||MTB change from baseline at Cycle 1 Day 8 in participants with ≥30% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥30% decrease in PSA at Cycle 4||||0.0927
91583624|NCT01959516|183057595|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.0250
91583625|NCT01959516|183057596|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Mixed Models Analysis|||||||0.1439
91646684|NCT04440163|183185124|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|11.4|||||TWO_SIDED|95.0|5.0|18.2||||||MenY||18.2|5.0|
91583626|NCT01191268|183057634|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.||-0.07|-0.38|<0.001
91583627|NCT01191268|183057634|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.33|<0.001
91583628|NCT01191268|183057634|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.005|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.38|0.005
91583629|NCT01191268|183057634|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.015|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.33|0.015
91583630|NCT01191268|183057635|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.07|-0.42|<0.001
91583631|NCT01191268|183057635|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.37|<0.001
91583632|NCT01191268|183057635|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.42|0.005
91583633|NCT01191268|183057635|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.014|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.37|0.014
91583634|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.014
91583635|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.010
91583636|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.027||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.027
91583637|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.384||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.384
91583638|NCT01191268|183057636|SUPERIORITY_OR_OTHER||||||<|0.05||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||<0.05
91646685|NCT04440163|183185125|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-2.2|||||TWO_SIDED|95.0|-5.2|1.4||||||MenA||1.4|-5.2|
91583639|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.25||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.250
91777695|NCT00541658|183436525|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.197|||||TWO_SIDED|95.0|-1.318|5.711|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.711|-1.318|
91790182|NCT02660138|183459523|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.03|||<|0.0001|TWO_SIDED|95.0|3.56|18.09||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 600 U versus Placebo.||18.09|3.56|<0.0001
91583640|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.272||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.272
91583641|NCT01191268|183057636|SUPERIORITY_OR_OTHER|||||||0.623||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.623
91583642|NCT01191268|183057637|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
91583643|NCT01191268|183057637|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
91583644|NCT01191268|183057637|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
91583645|NCT01191268|183057637|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
91583646|NCT01191268|183057638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.628|TWO_SIDED|95.0|-0.35|0.21||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.21|-0.35|0.628
91583647|NCT01191268|183057638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.368|TWO_SIDED|95.0|-0.15|0.41||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.41|-0.15|0.368
91583648|NCT01191268|183057638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.37|TWO_SIDED|95.0|-0.16|0.42||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.42|-0.16|0.370
91583649|NCT01191268|183057638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.879|TWO_SIDED|95.0|-0.26|0.3||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.30|-0.26|0.879
91583650|NCT01191268|183057639|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.83|1.79||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||1.79|0.83|<0.001
91583651|NCT01191268|183057639|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.001|TWO_SIDED|95.0|1.32|2.28||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||2.28|1.32|<0.001
91583652|NCT01191268|183057639|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.55|1.64||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.64|0.55|<0.001
91583653|NCT01191268|183057639|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|0.88|1.96||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.96|0.88|<0.001
91583654|NCT01191268|183057641|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|||<|0.001|TWO_SIDED|95.0|-3.81|-2.59||Treatment comparison at 26 weeks.|ANCOVA|||||-2.59|-3.81|<0.001
91583655|NCT01191268|183057641|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.76|-1.54||Treatment comparison at 26 weeks.|ANCOVA|||||-1.54|-2.76|<0.001
91790183|NCT02660138|183459523|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.47||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 800 U versus Placebo||18.47|3.66|<0.0001
91583656|NCT01191268|183057641|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.23|||<|0.001|TWO_SIDED|95.0|-3.99|-2.48||Treatment comparison at 52 weeks.|ANCOVA|||||-2.48|-3.99|<0.001
91583657|NCT01191268|183057641|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.03|||<|0.001|TWO_SIDED|95.0|-2.78|-1.27||Treatment comparison at 52 weeks.|ANCOVA|||||-1.27|-2.78|<0.001
91583658|NCT01191268|183057643|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.44|-0.96||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.96|-1.44|<0.001
91583659|NCT01191268|183057643|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|||<|0.001|TWO_SIDED|95.0|-1.03|-0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.55|-1.03|<0.001
91583660|NCT01191268|183057643|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.94||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.94|-1.55|<0.001
91583661|NCT01191268|183057643|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.06|-0.46||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.46|-1.06|<0.001
91583662|NCT01270971|183057720|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91583663|NCT01270971|183057721|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91583664|NCT01270971|183057722|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91583665|NCT01270971|183057723|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91583666|NCT01551212|183057724|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.097|TWO_SIDED|95.0|-0.74|8.91|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||8.91|-0.74|0.097
91646686|NCT04440163|183185125|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-1.3|||||TWO_SIDED|95.0|-4.9|2.9||||||MenC||2.9|-4.9|
91777696|NCT00541658|183436525|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.251|||||TWO_SIDED|95.0|-1.248|5.751|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.751|-1.248|
91777697|NCT00541658|183436526|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
91777698|NCT00541658|183436526|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
91777699|NCT00541658|183436527|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
91583667|NCT01551212|183057725|SUPERIORITY||Mean Difference (Final Values)|7.99||||0.0085|TWO_SIDED|95.0|2.06|13.92|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||13.92|2.06|0.0085
91583668|NCT01551212|183057726|SUPERIORITY|||||||0.699|||||||Fisher Exact|||||||0.699
91583669|NCT00705523|183057731|SUPERIORITY_OR_OTHER|||||||0.1|||||||Regression, Logistic|beta=-0.67, exp(beta)=0.51, chi-squared(1) = 0.2.71||Self-reported drinking results, as gathered by the TLFB, were compared by the generalized estimating equations (GEE) (Diggle et al., 1994), using Poisson models for counts of drinking and heavy drinking days, and logistic regression models for absence/presence binary indicators of drinking. In the GEE model, the pre-treatment of the response was included as a covariate, together with the treatment group indicator, and a linear time effect.||||0.10
91583670|NCT02482870|183057744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared|Chi-square value = 2.424; degrees of freedom = 1||Sample size was calculated according to the first 60 patients. To obtain 90% power with an alpha error of 0.05, a total of 378 patients were required. Considering a possible drop-out rate of 2.5% due to unexpected complications, we aimed for 388 patients.||||0.119
91583671|NCT02482870|183057745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.0001|TWO_SIDED|95.0|3.0|4.6||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||4.6|3|<0.0001
91583672|NCT02482870|183057746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.9|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||1.4|0.5|<0.0001
91646687|NCT04440163|183185125|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.0|||||TWO_SIDED|95.0|-1.6|4.6||||||MenW||4.6|-1.6|
91583673|NCT02482870|183057747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.67||A priori threshold for statistical significance was 0.05.|t-test, 2 sided|t value = -11.224, degrees of freedom = 773.99||"For each patient, the difference between Cormack-Lehane score and Mallampati class was calculated for each laryngoscope. As an example, the first patient had a Mallampati score 3. Macintosh laryngoscope provided a Cormack-Lehane score of 2, therefore the difference is - 1, calculated as 2 - 3. In the same patient, King Vision video laryngoscope provided a Cormack-Lehane score of 1, therefore the difference is - 2, calculated as 1 - 3. T-test was used to compare the differences."||-0.67|-0.95|<0.0001
91583674|NCT02482870|183057748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-square test with Yates' continuity correction: chi-square = 0.101; degrees of freedom = 1||||||0.75
91583675|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0213|TWO_SIDED|90.0|0.019|0.14||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg versus (vs) placebo, centrally read||0.140|0.019|0.0213
91583676|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.128||||0.0025|TWO_SIDED|90.0|0.056|0.199||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.199|0.056|0.0025
91583677|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.118||||0.004|TWO_SIDED|90.0|0.048|0.188||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.188|0.048|0.0040
91583678|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.026||||0.1803|TWO_SIDED|90.0|-0.012|0.064||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.064|-0.012|0.1803
91583679|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0582|TWO_SIDED|90.0|0.002|0.159||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.159|0.002|0.0582
91583680|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.178||||0.0014|TWO_SIDED|90.0|0.083|0.272||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.272|0.083|0.0014
91583681|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.122||||0.0125|TWO_SIDED|90.0|0.036|0.208||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.208|0.036|0.0125
91583682|NCT01620255|183057749|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.0927|TWO_SIDED|90.0|-0.009|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.142|-0.009|0.0927
91583683|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.089||||0.1379|TWO_SIDED|90.0|-0.037|0.214||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.214|-0.037|0.1379
91777700|NCT00541658|183436527|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
91777701|NCT00541658|183436528|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
91777702|NCT00541658|183436528|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
91583684|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.254||||0.0011|TWO_SIDED|90.0|0.121|0.388||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.388|0.121|0.0011
91583685|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.163||||0.0239|TWO_SIDED|90.0|0.032|0.293||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.293|0.032|0.0239
91583686|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.213||||0.0052|TWO_SIDED|90.0|0.08|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.347|0.080|0.0052
91583687|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.056||||0.2617|TWO_SIDED|90.0|-0.075|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.186|-0.075|0.2617
91583688|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.212||||0.0058|TWO_SIDED|90.0|0.077|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.347|0.077|0.0058
91583689|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.156||||0.0326|TWO_SIDED|90.0|0.022|0.29||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.290|0.022|0.0326
91583690|NCT01620255|183057750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.185||||0.0145|TWO_SIDED|90.0|0.05|0.32||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.320|0.050|0.0145
91583691|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.081||||0.0618|TWO_SIDED|90.0|0.0|0.162||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.162|0.000|0.0618
91583692|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.187||||0.0009|TWO_SIDED|90.0|0.091|0.284||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.284|0.091|0.0009
91583693|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.159||||0.0027|TWO_SIDED|90.0|0.068|0.25||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.250|0.068|0.0027
91583694|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.069||||0.0999|TWO_SIDED|90.0|-0.013|0.151||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.151|-0.013|0.0999
91583695|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.001||||0.5225|TWO_SIDED|90.0|-0.111|0.114||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.114|-0.111|0.5225
91708388|NCT03299101|183309712|SUPERIORITY||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|3.13||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.||||0.552
91583696|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.154||||0.0246|TWO_SIDED|90.0|0.03|0.278||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.278|0.030|0.0246
91583697|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.13||||0.0464|TWO_SIDED|90.0|0.008|0.253||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.253|0.008|0.0464
91583698|NCT01620255|183057751|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.2|TWO_SIDED|90.0|-0.053|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.186|-0.053|0.2000
91583699|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean (LSM) Difference|-0.88||||0.0494|TWO_SIDED|90.0|-1.623|-0.145|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, centrally read change||-0.145|-1.623|0.0494
91583700|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.53||||0.0005|TWO_SIDED|90.0|-2.254|-0.809|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, centrally read change||-0.809|-2.254|0.0005
91708389|NCT03299101|183309713|SUPERIORITY|||||||0.003||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.||||0.003
91583701|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.12||||0.0117|TWO_SIDED|90.0|-1.845|-0.39|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, centrally read change||-0.390|-1.845|0.0117
91583702|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.27||||0.0049|TWO_SIDED|90.0|-2.016|-0.533|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, centrally read change||-0.533|-2.016|0.0049
91583703|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.94||||0.0543|TWO_SIDED|90.0|-1.737|-0.137|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, locally read change||-0.137|-1.737|0.0543
91583704|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.6||||0.0008|TWO_SIDED|90.0|-2.372|-0.819|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, locally read change||-0.819|-2.372|0.0008
91583705|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.07||||0.0255|TWO_SIDED|90.0|-1.858|-0.284|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, locally read change||-0.284|-1.858|0.0255
91583706|NCT01620255|183057753|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.29||||0.0079|TWO_SIDED|90.0|-2.082|-0.493|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, locally read change||-0.493|-2.082|0.0079
91583707|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.1016|TWO_SIDED|90.0|-0.511|0.001|||Mixed Models Analysis|Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W4||0.001|-0.511|0.1016
91583708|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0654|TWO_SIDED|90.0|-0.529|-0.03|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W4||-0.030|-0.529|0.0654
91583709|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.15|TWO_SIDED|90.0|-0.472|0.031|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W4||0.031|-0.472|0.1500
91583710|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.38||||0.0132|TWO_SIDED|90.0|-0.637|-0.129|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W4||-0.129|-0.637|0.0132
91583711|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.3||||0.0526|TWO_SIDED|90.0|-0.555|-0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W8||-0.046|-0.555|0.0526
91583712|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.31||||0.0422|TWO_SIDED|90.0|-0.554|-0.058|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W8||-0.058|-0.554|0.0422
91777703|NCT00541658|183436529|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
91777704|NCT00541658|183436529|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
91777705|NCT00541658|183436530|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
91777706|NCT00541658|183436530|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
91777707|NCT00541658|183436531|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
91777708|NCT00541658|183436531|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
91777709|NCT00541658|183436532|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
91777710|NCT00541658|183436532|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
91777711|NCT00541658|183436533|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
91777712|NCT00541658|183436533|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
91777713|NCT03373240|183436534|OTHER|Examining stop signal reaction time changed across the 4-week training period|Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|2.79||0.003|TWO_SIDED|95.0|-14.17|-3.06|||Mixed Models Analysis|||||-3.06|-14.17|.003
91777714|NCT03373240|183436535|SUPERIORITY||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.127||0.049|TWO_SIDED|95.0|-0.333|0.184|||ANOVA|||||.184|-.333|.049
91777715|NCT03373240|183436536|SUPERIORITY||Mean Difference (Net)|-1.914|STANDARD_ERROR_OF_MEAN|1.011||0.236|TWO_SIDED|95.0|-3.965|0.136|||ANOVA|||||.136|-3.965|.236
91777716|NCT03373240|183436537|OTHER|Examining whether percentage of risky choices decreased across the 4-wwek training period.|Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.77||0.039|TWO_SIDED|95.0|-3.15|-0.08|||Mixed Models Analysis|||||-.08|-3.15|.039
91583713|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.011|TWO_SIDED|90.0|-0.637|-0.137|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W8||-0.137|-0.637|0.0110
91583714|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.5||||0.001|TWO_SIDED|90.0|-0.755|-0.254|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W8||-0.254|-0.755|0.0010
91777717|NCT03373240|183436538|OTHER||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|0.82||0.035|TWO_SIDED|95.0|-3.4|-0.13|||Mixed Models Analysis|||||-.13|-3.40|.035
91777718|NCT03373240|183436539|OTHER||Mean Difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|3.12|5.39|||Mixed Models Analysis|||||5.39|3.12|<.001
91777719|NCT03373240|183436540|SUPERIORITY||Mean Difference (Net)|0.933|STANDARD_ERROR_OF_MEAN|0.403||0.008|TWO_SIDED|95.0|0.111|1.755|||ANOVA|||||1.755|.111|.008
91777720|NCT03373240|183436541|SUPERIORITY||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.096||0.077|TWO_SIDED|97.0|-0.177|0.214|||ANOVA|||||.214|-.177|.077
91777721|NCT03373240|183436542|SUPERIORITY||Mean Difference (Net)|-0.964|STANDARD_ERROR_OF_MEAN|1.902||0.547|TWO_SIDED|95.0|-4.822|2.895|||ANOVA|||||2.895|-4.822|.547
91777722|NCT03373240|183436543|SUPERIORITY||Mean Difference (Net)|-0.532|STANDARD_ERROR_OF_MEAN|0.628||0.436|TWO_SIDED|95.0|-1.805|0.742|||ANOVA|||||.742|-1.805|.436
91777723|NCT02867436|183436544|SUPERIORITY||Mean Difference (Final Values)|205.0|||<|0.05|TWO_SIDED|95.0|-223.0|633.0|||Regression, Linear|||||633|-223|<0.05
91777724|NCT02867436|183436545|SUPERIORITY||Mean Difference (Final Values)|-7.8|||<|0.05|TWO_SIDED|95.0|-14.1|-1.6|||Regression, Linear|||||-1.6|-14.1|<0.05
91777725|NCT02867436|183436546|SUPERIORITY||Mean Difference (Final Values)|-0.15|||<|0.05|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||||0.01|-0.31|<0.05
91777726|NCT02867436|183436547|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91777727|NCT02867436|183436548|SUPERIORITY||||||<|0.05||||||After Benjamini-Hochberg correction for multiple comparisons|ANOVA|||||||<0.05
91777728|NCT05178173|183436693|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.59
91777729|NCT05178173|183436693|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.18
91777730|NCT05178173|183436693|SUPERIORITY|||||||0.78||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.78
91777731|NCT05178173|183436693|SUPERIORITY|||||||0.08||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.08
91777732|NCT02086175|183436767|SUPERIORITY||percent|48.0||||0.044|TWO_SIDED|90.0|31.0|66.0|||Fisher Exact|||"Patients will be accrued in a single stage design, with a goal accrual of 25 patients.~Assuming a 30% response rate with rituximab alone, if the true but unknown rate of CR or PR is 50% with the addition of Imprime PGG, the probability of observing 11 or more patients with a response is 0.79 with 0.098 one-sided type-I error.~Therefore a study with 25 patients, in which an observed response rate of 11/25 (44%) would be considered worthy of further consideration."||66|31|0.044
91777733|NCT04314284|183436774|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
91777734|NCT04314284|183436775|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
91777735|NCT04314284|183436776|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
91777736|NCT04314284|183436780|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
91777737|NCT04314284|183436781|SUPERIORITY|||||||0.52|||||||Kruskal-Wallis|||||||0.52
91777738|NCT04314284|183436782|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
91777739|NCT04314284|183436785|OTHER|2-sided||||||0.71|||||||t-test, 2 sided|||||||0.71
91777740|NCT04314284|183436786|OTHER|2-sided||||||0.12|||||||t-test, 2 sided|||||||0.12
91777741|NCT04314284|183436788|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||0.66
91777742|NCT04607005|183436821|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.067|TWO_SIDED|95.0|-0.89|0.03||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||0.03|-0.89|0.067
91777743|NCT04607005|183436822|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.043|TWO_SIDED|95.0|-0.92|-0.02||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.02|-0.92|0.043
91777744|NCT04607005|183436823|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.003|TWO_SIDED|95.0|-2.37|-0.5||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.50|-2.37|0.003
91777745|NCT04607005|183436824|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.002|TWO_SIDED|95.0|-2.35|-0.51||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.51|-2.35|0.002
91777746|NCT04607005|183436825|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.003|TWO_SIDED|95.0|-2.52|-0.55||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.55|-2.52|0.003
91777747|NCT04607005|183436826|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.51|-0.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.57|-2.51|0.002
91777748|NCT04607005|183436827|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.012|TWO_SIDED|95.0|-2.9|-0.37||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.37|-2.90|0.012
91777749|NCT04607005|183436828|SUPERIORITY||Mean Difference (Final Values)|-1.67||||0.009|TWO_SIDED|95.0|-2.93|-0.42||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.42|-2.93|0.009
91777750|NCT04607005|183436829|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.005|TWO_SIDED|95.0|-1.99|-0.35||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.35|-1.99|0.005
91777751|NCT04607005|183436830|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.004|TWO_SIDED|95.0|-2.02|-0.4||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.40|-2.02|0.004
91777752|NCT04607005|183436831|SUPERIORITY||Mean Difference (Final Values)|-10.63||||0.01|TWO_SIDED|95.0|-18.68|-2.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-2.57|-18.68|0.010
91583715|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1611|TWO_SIDED|90.0|-0.475|0.038|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W12||0.038|-0.475|0.1611
91583716|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.36||||0.0186|TWO_SIDED|90.0|-0.608|-0.108|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W12||-0.108|-0.608|0.0186
91583717|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1647|TWO_SIDED|90.0|-0.465|0.039|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W12||0.039|-0.465|0.1647
91583718|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.35||||0.0231|TWO_SIDED|90.0|-0.607|-0.097|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W12||-0.097|-0.607|0.0231
91583719|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.46||||0.0002|TWO_SIDED|90.0|-0.658|-0.26|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4||-0.260|-0.658|0.0002
91583720|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.52|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.322|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4||-0.322|-0.710|<0.0001
91583721|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.49|||<|0.0001|TWO_SIDED|90.0|-0.686|-0.295|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W4||-0.295|-0.686|<0.0001
91583722|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.0012|TWO_SIDED|90.0|-0.587|-0.192|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W4||-0.192|-0.587|0.0012
91583723|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0207|TWO_SIDED|90.0|-0.475|-0.081|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8||-0.081|-0.475|0.0207
91583724|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0402|TWO_SIDED|90.0|-0.432|-0.048|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8||-0.048|-0.432|0.0402
91583725|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0071|TWO_SIDED|90.0|-0.511|-0.124|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W8||-0.124|-0.511|0.0071
91646688|NCT04440163|183185125|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-3.0|5.0||||||MenY||5.0|-3.0|
91777753|NCT04607005|183436832|SUPERIORITY||Mean Difference (Final Values)|-11.39||||0.004|TWO_SIDED|95.0|-19.19|-3.6||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-3.60|-19.19|0.004
91777754|NCT04607005|183436833|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.009|TWO_SIDED|95.0|-1.43|-0.21||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.21|-1.43|0.009
91583726|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.47|||<|0.0001|TWO_SIDED|90.0|-0.664|-0.275|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W8||-0.275|-0.664|<0.0001
91583727|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0395|TWO_SIDED|90.0|-0.449|-0.05|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12||-0.050|-0.449|0.0395
91583728|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0073|TWO_SIDED|90.0|-0.511|-0.123|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12||-0.123|-0.511|0.0073
91583729|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0413|TWO_SIDED|90.0|-0.439|-0.047|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W12||-0.047|-0.439|0.0413
91583730|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.4||||0.0008|TWO_SIDED|90.0|-0.602|-0.206|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W12||-0.206|-0.602|0.0008
91583731|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.19||||0.1862|TWO_SIDED|90.0|-0.421|0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W4||0.046|-0.421|0.1862
91777755|NCT04607005|183436834|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.004|TWO_SIDED|95.0|-1.49|-0.28||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.28|-1.49|0.004
91777756|NCT04607005|183436835|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.026|TWO_SIDED|95.0|0.26|0.92||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.92|0.26|0.026
91777757|NCT04607005|183436836|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.018|TWO_SIDED|95.0|0.25|0.88||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.88|0.25|0.018
91777758|NCT02711891|183436844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Paired Sample T-test|||||||0.8
91777759|NCT02711891|183436844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Paired Sample T-test|||||||.003
91777760|NCT02711891|183436844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||t-test, 2 sided|||||||0.002
91583732|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0998|TWO_SIDED|90.0|-0.455|0.0|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W4||-0.000|-0.455|0.0998
91583733|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1085|TWO_SIDED|90.0|-0.453|0.006|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W4||0.006|-0.453|0.1085
91583734|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.14||||0.3161|TWO_SIDED|90.0|-0.372|0.09|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W4||0.090|-0.372|0.3161
91583735|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.1||||0.4962|TWO_SIDED|90.0|-0.328|0.136|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W8||0.136|-0.328|0.4962
91583736|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.29||||0.0371|TWO_SIDED|90.0|-0.512|-0.06|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W8||-0.060|-0.512|0.0371
91583737|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1212|TWO_SIDED|90.0|-0.441|0.013|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W8||0.013|-0.441|0.1212
91583738|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.18||||0.187|TWO_SIDED|90.0|-0.41|0.045|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W8||0.045|-0.410|0.1870
91646689|NCT00589693|183185131|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%|Difference of 2 binomial proportions|-11.2|||||TWO_SIDED|95.0|-26.3|3.8|||Normal approximation of 2 proportions|||Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin||3.8|-26.3|
91646690|NCT00589693|183185132|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-18.8|||||TWO_SIDED|95.0|-57.2|19.5|||Normal approximation of 2 proportions|||||19.5|-57.2|
91646691|NCT00589693|183185133|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-5.6|||||TWO_SIDED|95.0|-23.0|11.7|||Normal approximation of 2 proportions|||||11.7|-23.0|
91583739|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.1133|TWO_SIDED|90.0|-0.459|0.009|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W12||0.009|-0.459|0.1133
91583740|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.43||||0.0022|TWO_SIDED|90.0|-0.653|-0.198|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W12||-0.198|-0.653|0.0022
91583741|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0788|TWO_SIDED|90.0|-0.475|-0.016|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W12||-0.016|-0.475|0.0788
91583742|NCT01620255|183057754|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0717|TWO_SIDED|90.0|-0.485|-0.022|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W12||-0.022|-0.485|0.0717
91777761|NCT02711891|183436846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||t-test, 1 sided|||||||0.01
91583743|NCT01620255|183057755|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.08||||0.5406|TWO_SIDED|90.0|-0.286|0.131|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo||0.131|-0.286|0.5406
91583744|NCT01620255|183057755|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.42||||0.0007|TWO_SIDED|90.0|-0.628|-0.221|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo||-0.221|-0.628|0.0007
91583745|NCT01620255|183057755|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.34||||0.0063|TWO_SIDED|90.0|-0.549|-0.137|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 75 mg vs placebo||-0.137|-0.549|0.0063
91583746|NCT01620255|183057755|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0748|TWO_SIDED|90.0|-0.436|-0.018|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 225 mg vs placebo||-0.018|-0.436|0.0748
91583747|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.9||||0.9744|TWO_SIDED|90.0|-101.0|97.14|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||97.14|-101.00|0.9744
91646692|NCT00589693|183185134|SUPERIORITY_OR_OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
91646693|NCT00589693|183185135|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|6.7|||||TWO_SIDED|95.0|-5.0|18.5|||Normal approximation of 2 proportions|||||18.5|-5.0|
91646694|NCT01128153|183185136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.47|-0.86|<0.0001
91646695|NCT01128153|183185137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.667||0.0301|TWO_SIDED|95.0|-31.85|-1.62|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-1.62|-31.85|0.0301
91646696|NCT01128153|183185138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.426||0.0301|TWO_SIDED|95.0|-1.77|-0.09|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.09|-1.77|0.0301
91777762|NCT02711891|183436846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|0.05|||||Chi-squared|||||||.001
91777763|NCT02711891|183436848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||||||Comparison of mean BPM during lance procedure for L1 vs L2 Loperamide.|t-test, 1 sided|||The population BPM lance one = population BPM mean lance two. Loperamide 1= Loperamide 2. Placebo 1=Placebo 2.||||.876
91583748|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|74.9||||0.2023|TWO_SIDED|90.0|-21.77|171.66|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||171.66|-21.77|0.2023
91583749|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|32.9||||0.5808|TWO_SIDED|90.0|-65.09|130.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||130.79|-65.09|0.5808
91583750|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|37.6||||0.5388|TWO_SIDED|90.0|-63.12|138.34|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||138.34|-63.12|0.5388
91583751|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-8.2||||0.8902|TWO_SIDED|90.0|-106.24|89.81|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||89.81|-106.24|0.8902
91583752|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|10.2||||0.8616|TWO_SIDED|90.0|-86.14|106.54|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||106.54|-86.14|0.8616
91583753|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-34.3||||0.5684|TWO_SIDED|90.0|-133.49|64.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||64.79|-133.49|0.5684
91583754|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|33.8||||0.57|TWO_SIDED|90.0|-64.2|131.86|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||131.86|-64.20|0.5700
91583755|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-30.0||||0.6234|TWO_SIDED|90.0|-130.56|70.57|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||70.57|-130.56|0.6234
91583756|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|36.0||||0.5474|TWO_SIDED|90.0|-62.44|134.38|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||134.38|-62.44|0.5474
91583757|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|78.5||||0.1918|TWO_SIDED|90.0|-20.48|177.56|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||177.56|-20.48|0.1918
91646697|NCT01128153|183185139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|4.595||0.0868|TWO_SIDED|95.0|-16.96|1.15|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||1.15|-16.96|0.0868
91583758|NCT01620255|183057756|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-3.0||||0.9615|TWO_SIDED|90.0|-104.88|98.91|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||98.91|-104.88|0.9615
91583759|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|6.4||||0.9328|TWO_SIDED|90.0|-118.6|131.41|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||131.41|-118.60|0.9328
91583760|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-9.8||||0.8962|TWO_SIDED|90.0|-132.91|113.39|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||113.39|-132.91|0.8962
91583761|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.5||||0.8775|TWO_SIDED|90.0|-110.83|133.74|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||133.74|-110.83|0.8775
91583762|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-17.0||||0.8224|TWO_SIDED|90.0|-142.02|107.94|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||107.94|-142.02|0.8224
91583763|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-52.7||||0.4831|TWO_SIDED|90.0|-176.48|71.02|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||71.02|-176.48|0.4831
91583764|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.2||||0.1183|TWO_SIDED|90.0|-236.63|6.13|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||6.13|-236.63|0.1183
91583765|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.8||||0.1139|TWO_SIDED|90.0|-236.29|4.69|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||4.69|-236.29|0.1139
91583766|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-96.4||||0.1931|TWO_SIDED|90.0|-218.17|25.46|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||25.46|-218.17|0.1931
91583767|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-119.7||||0.1182|TWO_SIDED|90.0|-245.66|6.32|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||6.32|-245.66|0.1182
91583768|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-41.7||||0.5784|TWO_SIDED|90.0|-165.34|81.87|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||81.87|-165.34|0.5784
91646698|NCT01128153|183185140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.255||0.0868|TWO_SIDED|95.0|-0.94|0.06|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||0.06|-0.94|0.0868
91583769|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-163.6||||0.0279|TWO_SIDED|90.0|-285.84|-41.29|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||-41.29|-285.84|0.0279
91646699|NCT01128153|183185141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.006|||<|0.0001|TWO_SIDED|95.0|3.852|21.05|||ANCOVA||Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)|||21.05|3.852|<0.0001
91646700|NCT01954082|183185142|SUPERIORITY||Risk Ratio (RR)|1.41||||0.0095|TWO_SIDED|95.0|1.08|1.83||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality and/or severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the development of severe ROP and mortality.||1.83|1.08|0.0095
91646701|NCT01954082|183185143|SUPERIORITY||Risk Ratio (RR)|1.03||||0.6599|TWO_SIDED|95.0|0.91|1.16||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of BPD is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of BPD.||1.16|0.91|0.6599
91777764|NCT02711891|183436848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085||||||Comparison of the mean between HR one and HR two during the procedure for lance one will equal the mean HR lance two following loperamide gel application.|ANOVA|df 16.||Mean HR during the procedure for lance one will equal mean HR lance two following loperamide gel applciation||||.085
91777765|NCT01148979|183436866|OTHER|A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.||||<0.05
91777766|NCT00565084|183436881|SUPERIORITY_OR_OTHER||Difference in LS Means|0.06||||0.743||90.0|-0.23|0.35|||ANOVA|||Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.||0.35|-0.23|0.743
91777767|NCT02266888|183436895|SUPERIORITY||Hazard Ratio (HR)|0.673||||0.514|TWO_SIDED|90.0|0.248|1.826|||Regression, Cox||Hazard ratio estimated for Rituximab vs. Placebo|||1.826|0.248|0.514
91777768|NCT02266888|183436899|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91777769|NCT02266888|183436900|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91777770|NCT02266888|183436901|SUPERIORITY|||||||0.188|||||||Fisher Exact|||||||0.188
91777771|NCT02266888|183436904|SUPERIORITY||Mean Difference (Net)|-1.62||||0.015|TWO_SIDED|90.0|-2.64|-0.6|||Paired t-Test|||This is not a comparison between treatment groups, but rather a comparison between timepoints.The Rituximab and Placebo groups were combined for purposes of testing the hypothesis that there would be no change in SD between pre-enrollment and 180 days post-enrollment into the TVI.||-0.60|-2.64|0.015
91777772|NCT02266888|183436906|SUPERIORITY|||||||0.502|||||||Cochran-Mantel-Haenszel|||||||0.502
91583770|NCT01620255|183057757|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-123.5||||0.1053|TWO_SIDED|90.0|-249.0|1.93|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||1.93|-249.00|0.1053
91646702|NCT01954082|183185144|SUPERIORITY||Risk Ratio (RR)|1.05||||0.3883|TWO_SIDED|95.0|0.94|1.17||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of BPD or on mortality due to BDP.||1.17|0.94|0.3883
91777773|NCT02266888|183436907|SUPERIORITY|||||||0.448|||||||Fisher Exact|||||||0.448
91777774|NCT02224560|183436931|SUPERIORITY||Median Difference (Final Values)|-21.57||||0.0047|TWO_SIDED|95.0|-34.79|-6.67|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-6.67|-34.79|0.0047
91777775|NCT02224560|183436931|SUPERIORITY||Median Difference (Final Values)|-19.19||||0.0016|TWO_SIDED|95.0|-31.24|-7.69|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.69|-31.24|0.0016
91777776|NCT02224560|183436932|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0006|TWO_SIDED|95.0|1.75|8.47||Calculated using a Cochran-Mantel-Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||8.47|1.75|0.0006
91777777|NCT02224560|183436932|SUPERIORITY||Odds Ratio (OR)|3.27||||0.003|TWO_SIDED|95.0|1.47|7.26||Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||7.26|1.47|0.0030
91777778|NCT02224560|183436933|SUPERIORITY||Median Difference (Final Values)|-18.76||||0.0091|TWO_SIDED|95.0|-31.8|-4.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.43|-31.80|0.0091
91777779|NCT02224560|183436933|SUPERIORITY||Median Difference (Final Values)|-19.47||||0.0015|TWO_SIDED|95.0|-30.37|-7.47|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.47|-30.37|0.0015
91777780|NCT02224560|183436934|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0439|TWO_SIDED|95.0|1.02|3.3|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||3.30|1.02|0.0439
91777781|NCT02224560|183436934|SUPERIORITY||Odds Ratio (OR)|2.57||||0.002|TWO_SIDED|95.0|1.41|4.66|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||4.66|1.41|0.0020
91777782|NCT00728689|183436936|SUPERIORITY_OR_OTHER|||||||0.4591|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.4591
91583771|NCT01620255|183057758|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.1||||0.8302|TWO_SIDED|90.0|-9.507|7.317|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, change from BL at W12||7.317|-9.507|0.8302
91583772|NCT01620255|183057758|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|12.33||||0.0141|TWO_SIDED|90.0|4.084|20.567|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, change from BL at W12||20.567|4.084|0.0141
91583773|NCT01620255|183057758|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.7||||0.0182|TWO_SIDED|90.0|3.564|19.84|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, change from BL at W12||19.840|3.564|0.0182
91583774|NCT01620255|183057758|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|15.48||||0.0026|TWO_SIDED|90.0|7.056|23.907|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, change from BL at W12||23.907|7.056|0.0026
91583775|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.73||||0.6862|TWO_SIDED|90.0|-3.689|2.235|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12||2.235|-3.689|0.6862
91583776|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.37||||0.0135|TWO_SIDED|90.0|1.467|7.28|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12||7.280|1.467|0.0135
91583777|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.16||||0.0171|TWO_SIDED|90.0|1.293|7.023|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, bowel fx change from BL at W12||7.023|1.293|0.0171
91583778|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.2||||0.0041|TWO_SIDED|90.0|2.232|8.172|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, bowel fx change from BL at W12||8.172|2.232|0.0041
91583779|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|0.22||||0.9072|TWO_SIDED|90.0|-2.897|3.339|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12||3.339|-2.897|0.9072
91583780|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.47||||0.0161|TWO_SIDED|90.0|1.42|7.522|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12||7.522|1.420|0.0161
91583781|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.06||||0.0271|TWO_SIDED|90.0|1.042|7.071|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, emotional fx change from BL at W12||7.071|1.042|0.0271
91583782|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.9||||0.002|TWO_SIDED|90.0|2.778|9.026|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, emotional fx change from BL at W12||9.026|2.778|0.0020
91583783|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.26||||0.7711|TWO_SIDED|90.0|-1.756|1.229|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12||1.229|-1.756|0.7711
91777783|NCT00728689|183436937|SUPERIORITY_OR_OTHER|||||||0.0048|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-τ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0048
91777784|NCT00728689|183436938|SUPERIORITY_OR_OTHER|||||||0.0997|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-∞ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0997
91583784|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.69||||0.0582|TWO_SIDED|90.0|0.223|3.147|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12||3.147|0.223|0.0582
91583785|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.68||||0.0558|TWO_SIDED|90.0|0.235|3.12|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12||3.120|0.235|0.0558
91583786|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.66||||0.0686|TWO_SIDED|90.0|0.161|3.153|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12||3.153|0.161|0.0686
91583787|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.33||||0.7561|TWO_SIDED|90.0|-2.094|1.429|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, social fx change from BL at W12||1.429|-2.094|0.7561
91583788|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.17||||0.0384|TWO_SIDED|90.0|0.447|3.891|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, social fx change from BL at W12||3.891|0.447|0.0384
91583789|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.86||||0.0729|TWO_SIDED|90.0|0.154|3.557|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, social fx change from BL at W12||3.557|0.154|0.0729
91583790|NCT01620255|183057759|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.95||||0.006|TWO_SIDED|90.0|1.19|4.715|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, social fx change from BL at W12||4.715|1.190|0.0060
91583791|NCT01620255|183057760|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.002||||0.5201|TWO_SIDED|90.0|-0.145|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo||0.142|-0.145|0.5201
91583792|NCT01620255|183057760|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.183||||0.0217|TWO_SIDED|90.0|0.039|0.328||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo||0.328|0.039|0.0217
91583793|NCT01620255|183057760|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.096||||0.1473|TWO_SIDED|90.0|-0.045|0.237||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo||0.237|-0.045|0.1473
91583794|NCT01620255|183057760|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.112||||0.1231|TWO_SIDED|90.0|-0.038|0.261||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo||0.261|-0.038|0.1231
91583795|NCT03794908|183057763|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.49||0.28|TWO_SIDED|95.0|-3.03|10.64|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at mid-treatment.||10.64|-3.03|0.28
91583796|NCT03794908|183057763|SUPERIORITY||Mean Difference (Net)|4.48|STANDARD_ERROR_OF_MEAN|3.53||0.21|TWO_SIDED|95.0|-2.44|11.4|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at end of treatment.||11.40|-2.44|0.21
91583797|NCT04981366|183057788|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.013
91583798|NCT04981366|183057789|SUPERIORITY||||||<|0.001||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||<0.001
91583799|NCT04981366|183057790|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583800|NCT04981366|183057791|SUPERIORITY|||||||0.007||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.007
91583801|NCT04981366|183057792|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583802|NCT04981366|183057793|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583803|NCT04981366|183057794|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
91777785|NCT00728689|183436939|SUPERIORITY_OR_OTHER|||||||0.0422|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, Cmax was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0422
91777786|NCT00728689|183436940|SUPERIORITY_OR_OTHER|||||||0.8581|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.8581
91583804|NCT04981366|183057795|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583805|NCT04981366|183057796|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583806|NCT04981366|183057797|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583807|NCT04981366|183057798|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583808|NCT04981366|183057799|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91583809|NCT04981366|183057800|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|||||||0.033
91583810|NCT04981366|183057801|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
91583811|NCT04981366|183057802|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|||||||0.203
91583812|NCT04981366|183057803|SUPERIORITY|||||||0.027|||||||Mixed Models Analysis|||||||0.027
91583813|NCT04981366|183057804|SUPERIORITY|||||||0.145|||||||Mixed Models Analysis|||||||0.145
91583814|NCT04981366|183057805|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91583815|NCT04981366|183057806|SUPERIORITY|||||||0.551|||||||Mixed Models Analysis|||||||0.551
91583816|NCT04981366|183057807|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91583817|NCT04981366|183057808|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91583818|NCT04981366|183057809|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91583819|NCT04981366|183057810|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
91583820|NCT04981366|183057811|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583821|NCT04981366|183057812|SUPERIORITY|||||||0.344|||||||Mixed Models Analysis|||||||0.344
91583822|NCT04981366|183057813|SUPERIORITY|||||||0.613|||||||Mixed Models Analysis|||||||0.613
91583823|NCT04981366|183057814|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
91583824|NCT04981366|183057815|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
91583825|NCT04981366|183057816|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583826|NCT04981366|183057817|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583827|NCT04981366|183057818|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583828|NCT04981366|183057820|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583829|NCT04981366|183057821|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583830|NCT04981366|183057822|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583831|NCT04981366|183057823|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583832|NCT04981366|183057824|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
91583833|NCT04981366|183057825|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583834|NCT04981366|183057826|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||||||0.949
91583835|NCT04981366|183057827|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
91583836|NCT04981366|183057828|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
91583837|NCT04981366|183057829|SUPERIORITY|||||||0.408|||||||Mixed Models Analysis|||||||0.408
91777787|NCT01523366|183436941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-167.2|STANDARD_ERROR_OF_MEAN|14.6|<|0.001|TWO_SIDED|95.0|-197.0|-137.4|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|||-137.4|-197.0|<.001
91777788|NCT01523366|183436942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.2|STANDARD_ERROR_OF_MEAN|18.23|<|0.001|TWO_SIDED|95.0|-172.3|-98.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 0.5 hours after the loading dose||-98.0|-172.3|<.001
91583838|NCT04981366|183057830|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||0.082
91583839|NCT04981366|183057831|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.550
91583840|NCT04981366|183057832|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.700
91583841|NCT04981366|183057833|SUPERIORITY|||||||0.254|||||||Mixed Models Analysis|||||||0.254
91583842|NCT04981366|183057834|SUPERIORITY|||||||0.373|||||||Mixed Models Analysis|||||||0.373
91583843|NCT04981366|183057835|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||0.407
91583844|NCT04981366|183057836|SUPERIORITY|||||||0.051|||||||Mixed Models Analysis|||||||0.051
91583845|NCT04981366|183057837|SUPERIORITY|||||||0.385|||||||Mixed Models Analysis|||||||0.385
91583846|NCT04981366|183057838|SUPERIORITY|||||||0.239|||||||Mixed Models Analysis|||||||0.239
91583847|NCT04981366|183057839|SUPERIORITY|||||||0.463|||||||Mixed Models Analysis|||||||0.463
91583848|NCT04981366|183057840|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
91583849|NCT04981366|183057841|SUPERIORITY|||||||0.469|||||||Mixed Models Analysis|||||||0.469
91583850|NCT04981366|183057842|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
91583851|NCT04981366|183057843|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
91583852|NCT04981366|183057844|SUPERIORITY|||||||0.0314|||||||Mixed Models Analysis|||||||0.0314
91583853|NCT04981366|183057845|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|||||||0.0147
91583854|NCT04981366|183057846|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91583855|NCT04981366|183057847|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91583856|NCT04981366|183057848|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91583857|NCT02700945|183057869|SUPERIORITY|The 12-month Kaplan-Meier estimate will be reported for each arm. The hazard ratio estimate for the treatment effect with its 95% confidence interval will be reported.|Hazard Ratio (HR)|7.4|||<|0.001|TWO_SIDED|95.0|2.6|21.3||A priori threshold is .05|Log Rank||A hazard ratio of \> 1 indicates that continuous monitoring arm is superior to control arm in detecting AF.|H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.||21.3|2.6|<0.001
91583858|NCT04018092|183057882|SUPERIORITY|||||||0.573||||||Only 2 values, thus not necessary to adjust.|Regression, Linear|The independent variable = intervention (active, sham); Covariates=baseline scores, site (Florida, Arizona), age (yrs), sex (m,f), and education (yrs)||linear regression was used to analyze pre-post intervention changes in the active vs sham group. Covariates in regression were baseline cognitive performance, site (University of Florida, University of Arizona), age (yrs), sex (F, M) and education (years)||||0.573
91583859|NCT04018092|183057883|SUPERIORITY|||||||0.043||||||Default Mode Network Analysis: Regression was performed using permutation tests with 5000 iterations for significance and to address multiple comparisons.|Regression, Linear|Covariates: Baseline network segregation values, Age, Sex, Education years, study site Baseline white matter hyperintensity volume. DOF = (1, 135)||||||0.043
91583860|NCT04018092|183057883|SUPERIORITY|||||||0.285||||||Frontoparietal Control Network Analysis: Regression was performed using permutation tests with 5000 iterations for significance and to address multiple comparisons.|Regression, Linear|Covariates: Baseline network segregation values, age, sex, education years, study site and baseline white matter hyperintensity volume. DOF = (1, 135)||||||0.285
91583861|NCT04218084|183057884|OTHER|Mixed Model Repeated Measures analysis|Difference in LS mean|-7.73||||0.0043|TWO_SIDED|95.0|-13.03|-2.42|||Mixed Models for Repeated Measures|||Week 24||-2.42|-13.03|0.0043
91583862|NCT01205152|183057906|OTHER|||||||0.002||||||Two-sided with p-value threshold \<0.05 for statistical significance.|Wilcoxon signed-rank test|||Change is relative to Baseline in Study ENB-002-08 (NCT00744042). The RGI-C score represents evaluation of skeletal X-rays at each post-treatment study timepoint compared with pre-treatment X-rays from Study ENB-002-08 using an ordinal scale. Therefore, an RGI-C score is not applicable for radiographs obtained at Baseline.||||0.0020
91777789|NCT01523366|183436942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-168.9|STANDARD_ERROR_OF_MEAN|17.28|<|0.001|TWO_SIDED|95.0|-204.0|-133.7|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 8 hours after the loading dose||-133.7|-204.0|<.001
91583863|NCT02783768|183057912|OTHER|Testing for difference in the outcome measure according to the exposure (which was not a treatment) in a randomized crossover setting.|Mean Difference (Net)|13.98||||0.012|TWO_SIDED|95.0|4.012|23.94|||Mixed Models Analysis||Measurements were included for participants with at least one valid MRI measurement.|"Within-person effects of e-cigarette exposure on pulmonary microvascular blood flow (PMBF) was assessed via mixed models accounting for order effects.~Null hypothesis: e-cigarette exposure is NOT associated with a change in PMBF.~Alternative hypothesis: e-cigarette exposure IS associated with a change in PMBF.~Power calculation: not applicable since this was a pilot/feasibility study."||23.94|4.012|0.012
91583864|NCT01037244|183057937|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Means|5.04|||<|0.0001|TWO_SIDED|95.0|3.36|6.73|||ANCOVA|Baseline Domain Score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||6.73|3.36|<0.0001
91583865|NCT01037244|183057937|SUPERIORITY_OR_OTHER||Difference in LS Means|7.18|||<|0.0001|TWO_SIDED|95.0|5.49|8.86|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||8.86|5.49|<0.0001
91583866|NCT01037244|183057937|SUPERIORITY_OR_OTHER||Difference in LS Means|7.95|||<|0.0001|TWO_SIDED|95.0|6.27|9.63|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||9.63|6.27|<0.0001
91583867|NCT01037244|183057938|SUPERIORITY_OR_OTHER||Difference in LS Means|18.6|||<|0.0001|TWO_SIDED|95.0|11.72|25.48|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.48|11.72|<0.0001
91583868|NCT01037244|183057938|SUPERIORITY_OR_OTHER||Difference in LS Means|29.02|||<|0.0001|TWO_SIDED|95.0|22.13|35.9|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||35.90|22.13|<0.0001
91583869|NCT01037244|183057938|SUPERIORITY_OR_OTHER||Difference in LS Means|31.51|||<|0.0001|TWO_SIDED|95.0|24.68|38.34|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||38.34|24.68|<0.0001
91583870|NCT01037244|183057939|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
91583871|NCT01037244|183057939|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
91583872|NCT01037244|183057939|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
91583873|NCT01037244|183057939|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
91521083|NCT01345630|182916902|NON_INFERIORITY_OR_EQUIVALENCE|For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.|Mean Difference (Final Values)|-9.54|||||TWO_SIDED|95.0|-14.83|-4.24||||||The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (\>=100,000 copies/mL or \<100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.||-4.24|-14.83|
91521084|NCT01345630|182916910|SUPERIORITY_OR_OTHER||Treatment difference|-0.075|STANDARD_ERROR_OF_MEAN|0.0303|||TWO_SIDED|95.0|-0.1343|-0.0157||||||The difference in proportions of patients with plasma HIV-1 RNA \<50 copies/mL at Week 48 between the \[MVC+DRV/r\] and the \[FTC/TDF+DRV/r\] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.||-0.0157|-0.1343|
91777790|NCT01523366|183436943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-150.5|STANDARD_ERROR_OF_MEAN|12.97|<|0.001|TWO_SIDED|95.0|-176.9|-124.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-124.1|-176.9|<.001
91521085|NCT01345630|182916915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.975|TWO_SIDED|95.0|-24.4|23.6|||ANCOVA|||Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||23.6|-24.4|0.9750
91521086|NCT01345630|182916916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-1.5|-3.1|<0.0001
91521087|NCT01345630|182916917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|127.7|||<|0.0001|TWO_SIDED|95.0|76.5|178.8|||ANCOVA|||Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||178.8|76.5|<0.0001
91521088|NCT01345630|182916918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.1|3.1|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||3.1|1.1|<0.0001
91521089|NCT01345630|182916919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.07|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-0.07|-0.15|<0.0001
91521090|NCT01345630|182916920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.861||||0.8379|TWO_SIDED|95.0|-658.181|809.903|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||809.903|-658.181|0.8379
91521091|NCT01345630|182916921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.3376|TWO_SIDED|95.0|-0.033|0.094|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.094|-0.033|0.3376
91521092|NCT01345630|182916922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014||||0.0043|TWO_SIDED|95.0|0.004|0.023|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.023|0.004|0.0043
91777791|NCT01523366|183436943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-140.2|STANDARD_ERROR_OF_MEAN|13.84|<|0.001|TWO_SIDED|95.0|-168.4|-111.9|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at 8 hours on Day 7 after multiple doses||-111.9|-168.4|<.001
91521093|NCT01345630|182916923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.2273|TWO_SIDED|95.0|-0.005|0.022|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.022|-0.005|0.2273
91521094|NCT01345630|182916924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.4188|TWO_SIDED|95.0|-0.007|0.018|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.018|-0.007|0.4188
91613262|NCT03478878|183120989|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.577|TWO_SIDED|95.0|-27.43|31.02||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||31.02|-27.43|0.577
91777792|NCT01523366|183436943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-130.6|STANDARD_ERROR_OF_MEAN|13.41|<|0.001|TWO_SIDED|95.0|-158.0|-103.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at end of dosing interval on Day 8||-103.2|-158.0|<.001
91777793|NCT00929695|183437019|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
91583874|NCT01037244|183057940|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.59|0.30|<0.0001
91583875|NCT01037244|183057940|SUPERIORITY_OR_OTHER||Difference in LS Means|0.68|||<|0.0001|TWO_SIDED|95.0|0.54|0.83|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.83|0.54|<0.0001
91583876|NCT01037244|183057940|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8|||<|0.0001|TWO_SIDED|95.0|0.66|0.95|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.95|0.66|<0.0001
91583877|NCT01037244|183057941|SUPERIORITY_OR_OTHER||Difference in LS Means|16.67|||<|0.0001|TWO_SIDED|95.0|11.23|22.11|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||22.11|11.23|<0.0001
91583878|NCT01037244|183057941|SUPERIORITY_OR_OTHER||Difference in LS Means|22.57|||<|0.0001|TWO_SIDED|95.0|17.11|28.03|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||28.03|17.11|<0.0001
91583879|NCT01037244|183057941|SUPERIORITY_OR_OTHER||Difference in LS Means|28.39|||<|0.0001|TWO_SIDED|95.0|22.98|33.79|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||33.79|22.98|<0.0001
91583880|NCT01037244|183057942|SUPERIORITY_OR_OTHER||Difference in LS Means|1.89|||<|0.0001|TWO_SIDED|95.0|1.17|2.61|||ANCOVA|P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.61|1.17|<0.0001
91583881|NCT01037244|183057942|SUPERIORITY_OR_OTHER||Difference in LS Means|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|2.99|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.99|1.54|<0.0001
91583882|NCT01037244|183057942|SUPERIORITY_OR_OTHER||Difference in LS Means|3.02|||<|0.0001|TWO_SIDED|95.0|2.3|3.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.73|2.30|<0.0001
91777794|NCT00929695|183437019|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.4
91777795|NCT00929695|183437027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.14|1.33||||||||1.33|0.14|
91777796|NCT00929695|183437028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.009|TWO_SIDED|95.0|0.12|0.74|||Regression, Cox|||||0.74|0.12|0.009
91777797|NCT00929695|183437030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.95|TWO_SIDED|95.0|0.6|1.74|||Regression, Cox|||||1.74|0.6|0.95
91583883|NCT01037244|183057943|SUPERIORITY_OR_OTHER||Difference in LS Means|1.42|||<|0.0001|TWO_SIDED|95.0|0.81|2.03|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.03|0.81|<0.0001
91613263|NCT03478878|183120990|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.646|TWO_SIDED|95.0|-7.6|11.35||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||11.35|-7.60|0.646
91708390|NCT03299101|183309713|SUPERIORITY||Mean Difference (Net)|7.48|STANDARD_ERROR_OF_MEAN|2.48||0.003|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.||||0.003
91583884|NCT01037244|183057943|SUPERIORITY_OR_OTHER||Difference in LS Means|1.65|||<|0.0001|TWO_SIDED|95.0|1.04|2.26|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.26|1.04|<0.0001
91583885|NCT01037244|183057943|SUPERIORITY_OR_OTHER||Difference in LS Means|1.98|||<|0.0001|TWO_SIDED|95.0|1.37|2.59|||ANCOVA|P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.59|1.37|<0.0001
91583886|NCT01037244|183057944|SUPERIORITY_OR_OTHER||Difference in LS Means|0.57||||0.0019|TWO_SIDED|95.0|0.21|0.93|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.93|0.21|0.0019
91583887|NCT01037244|183057944|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74|||<|0.0001|TWO_SIDED|95.0|0.38|1.1|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.10|0.38|<0.0001
91583888|NCT01037244|183057944|SUPERIORITY_OR_OTHER||Difference in LS Means|0.85|||<|0.0001|TWO_SIDED|95.0|0.49|1.21|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.21|0.49|<0.0001
91583889|NCT01037244|183057945|SUPERIORITY_OR_OTHER||Difference in LS Means|1.66|||<|0.0001|TWO_SIDED|95.0|1.13|2.19|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.19|1.13|<0.0001
91708391|NCT03299101|183309713|SUPERIORITY||Mean Difference (Net)|10.18|STANDARD_ERROR_OF_MEAN|3.61||0.005|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.||||0.005
91708392|NCT03299101|183309713|SUPERIORITY||Mean Difference (Net)|2.31|STANDARD_ERROR_OF_MEAN|2.18||0.29|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.||||0.290
91708393|NCT03299101|183309714|SUPERIORITY|||||||0.009||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.||||0.009
91708394|NCT03299101|183309714|SUPERIORITY||Mean Difference (Net)|12.61|STANDARD_ERROR_OF_MEAN|4.57||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.||||0.006
91708395|NCT03299101|183309714|SUPERIORITY||Mean Difference (Net)|12.79|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.||||0.015
91708396|NCT03299101|183309714|SUPERIORITY||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|3.42||0.802|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.||||0.802
91777798|NCT01352715|183437094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.|Cumulative probability difference|-3.4|||||TWO_SIDED|95.0|-8.4|1.5||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.||1.5|-8.4|
91646703|NCT01954082|183185145|SUPERIORITY||Risk Ratio (RR)|1.53||||0.0306|TWO_SIDED|95.0|1.03|2.25||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality prior to ROP endpoint is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on survival to ROP endpoint.||2.25|1.03|0.0306
91646704|NCT01954082|183185146|SUPERIORITY||Risk Ratio (RR)|1.02||||0.7464|TWO_SIDED|95.0|0.91|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of ROP||1.14|0.91|0.7464
91646705|NCT01954082|183185147|SUPERIORITY||Risk Ratio (RR)|0.98||||0.7598|TWO_SIDED|95.0|0.83|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of Type 2 ROP or more severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of Type 2 ROP or more severe ROP.||1.14|0.83|0.7598
91646706|NCT01954082|183185148|SUPERIORITY||Risk Ratio (RR)|1.04||||0.8133|TWO_SIDED|95.0|0.74|1.48||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of severe IVH is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence severe IVH.||1.48|0.74|0.8133
91646707|NCT01682512|183185163|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of \[-0.5, 0.5\].|Adjusted mean difference|-0.4|||||TWO_SIDED|90.0|-0.83|-0.03||Model analyzed was: DAS28(ESR) change from Baseline at Week 24 = overall mean + treatment + DAS28(ESR) Baseline score + visit + visit by treatment interaction + baseline-by-visit interaction + random error.|Mixed Models Analysis|A restricted maximum likelihood (REML)-based Mixed-Effect Model Repeated Measure (MMRM) approach was used.|Adjusted mean difference was calculated as: BI 695500 - Rituxan®|||-0.03|-0.83|
91646708|NCT01682512|183185164|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.35|STANDARD_ERROR_OF_MEAN|107.7|||TWO_SIDED|90.0|90.5|115.76|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.||115.76|90.50|
91646709|NCT01682512|183185164|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|88.21|STANDARD_ERROR_OF_MEAN|107.5|||TWO_SIDED|90.0|78.24|99.46|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.||99.46|78.24|
91646710|NCT01682512|183185164|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.18|STANDARD_ERROR_OF_MEAN|107.449|||TWO_SIDED|90.0|76.5|97.09|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.||97.09|76.50|
91646711|NCT01682512|183185165|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.46|STANDARD_ERROR_OF_MEAN|107.939|||TWO_SIDED|90.0|90.26|116.3|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.||116.30|90.26|
91708397|NCT03299101|183309715|SUPERIORITY|||||||0.01||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.||||0.010
91583890|NCT01037244|183057945|SUPERIORITY_OR_OTHER||Difference in LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|1.23|2.29|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.29|1.23|<0.0001
91583891|NCT01037244|183057945|SUPERIORITY_OR_OTHER||Difference in LS Means|2.56|||<|0.0001|TWO_SIDED|95.0|2.03|3.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.09|2.03|<0.0001
91583892|NCT01037244|183057946|SUPERIORITY_OR_OTHER||Difference in LS Means|12.34|||<|0.0001|TWO_SIDED|95.0|7.29|17.4|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||17.40|7.29|<0.0001
91583893|NCT01037244|183057946|SUPERIORITY_OR_OTHER||Difference in LS Means|19.29|||<|0.0001|TWO_SIDED|95.0|14.23|24.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.36|14.23|<0.0001
91583894|NCT01037244|183057946|SUPERIORITY_OR_OTHER||Difference in LS Means|19.16|||<|0.0001|TWO_SIDED|95.0|14.14|24.18|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled sites as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.18|14.14|<0.0001
91583895|NCT01037244|183057947|SUPERIORITY_OR_OTHER||Difference in LS Means|18.07|||<|0.0001|TWO_SIDED|95.0|10.7|25.43|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.43|10.70|<0.0001
91583896|NCT01037244|183057947|SUPERIORITY_OR_OTHER||Difference in LS Means|23.53|||<|0.0001|TWO_SIDED|95.0|16.12|30.94|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||30.94|16.12|<0.0001
91583897|NCT01037244|183057947|SUPERIORITY_OR_OTHER||Difference in LS Means|36.25|||<|0.0001|TWO_SIDED|95.0|28.92|43.59|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||43.59|28.92|<0.0001
91646712|NCT01682512|183185165|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.0|STANDARD_ERROR_OF_MEAN|107.404|||TWO_SIDED|90.0|76.38|96.82|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.||96.82|76.38|
91708398|NCT03299101|183309715|SUPERIORITY||Mean Difference (Net)|12.37|STANDARD_ERROR_OF_MEAN|4.35||0.004|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.||||0.004
91583898|NCT01037244|183057948|SUPERIORITY_OR_OTHER||Difference in LS Means|18.2|||<|0.0001|TWO_SIDED|95.0|10.79|25.6|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.60|10.79|<0.0001
91583899|NCT01037244|183057948|SUPERIORITY_OR_OTHER||Difference in LS Means|25.25|||<|0.0001|TWO_SIDED|95.0|17.82|32.69|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||32.69|17.82|<0.0001
91583900|NCT01037244|183057948|SUPERIORITY_OR_OTHER||Difference in LS Means|36.99|||<|0.0001|TWO_SIDED|95.0|29.63|44.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||44.36|29.63|<0.0001
91583901|NCT01037244|183057949|SUPERIORITY_OR_OTHER||Difference in LS Means|19.98|||<|0.0001|TWO_SIDED|95.0|12.69|27.26|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||27.26|12.69|<0.0001
91583902|NCT01037244|183057949|SUPERIORITY_OR_OTHER||Difference in LS Means|27.58|||<|0.0001|TWO_SIDED|95.0|20.29|34.88|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||34.88|20.29|<0.0001
91583903|NCT01037244|183057949|SUPERIORITY_OR_OTHER||Difference in LS Means|37.8|||<|0.0001|TWO_SIDED|95.0|30.57|45.03|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||45.03|30.57|<0.0001
91583904|NCT00690820|183057950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91583905|NCT00690820|183057951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91583906|NCT00690820|183057952|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91708399|NCT03299101|183309715|SUPERIORITY||Mean Difference (Net)|9.95|STANDARD_ERROR_OF_MEAN|4.9||0.042|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.||||0.042
91583907|NCT00690820|183057953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91583908|NCT00690820|183057954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91583909|NCT00690820|183057955|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.671
91583910|NCT00690820|183057956|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.003
91708400|NCT03299101|183309715|SUPERIORITY||Mean Difference (Net)|-3.77|STANDARD_ERROR_OF_MEAN|3.08||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.221
91521095|NCT01345630|182916925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.1722|TWO_SIDED|95.0|-5.17|0.94|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.94|-5.17|0.1722
91521096|NCT01345630|182916926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.78||||0.0071|TWO_SIDED|95.0|-218.34|-35.23|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||-35.23|-218.34|0.0071
91521097|NCT04676425|182916927|OTHER||Least-Squares Geometric Mean Ratio|1.19|||||TWO_SIDED|90.0|0.7|2.01|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||2.01|0.70|
91521098|NCT04676425|182916928|OTHER||Least-Squares Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.86|1.74|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||1.74|0.86|
91521099|NCT00939874|182916970|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91521100|NCT02231177|182916974|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|STANDARD_DEVIATION|32.15|||TWO_SIDED|90.0|0.99|1.27|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.27|0.99|
91521101|NCT02231177|182916975|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|STANDARD_DEVIATION|27.17|||TWO_SIDED|90.0|1.01|1.22|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.22|1.01|
91521102|NCT02231177|182916976|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|STANDARD_DEVIATION|20.43|||TWO_SIDED|90.0|0.91|1.06|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||1.06|0.91|
91521103|NCT02231177|182916977|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05|STANDARD_DEVIATION|19.85|||TWO_SIDED|90.0|0.98|1.13|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.13|0.98|
91521104|NCT02231177|182916978|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|STANDARD_DEVIATION|19.81|||TWO_SIDED|90.0|0.83|0.98|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||0.98|0.83|
91521105|NCT02231177|182916979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|STANDARD_DEVIATION|29.92|||TWO_SIDED|90.0|0.87|1.07|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.07|0.87|
91521106|NCT02231177|182916980|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02|STANDARD_DEVIATION|21.33|||TWO_SIDED|90.0|0.93|1.12|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg : Olodaterol 10 µg). No formal testing.||1.12|0.93|
91521107|NCT02231177|182916981|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|STANDARD_DEVIATION|22.61|||TWO_SIDED|90.0|0.84|1.0|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.00|0.84|
91777799|NCT00871975|183437129|SUPERIORITY_OR_OTHER||Sensitivity (percent)|80.6|||||TWO_SIDED||||||||We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
91646713|NCT01682512|183185165|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|83.93|STANDARD_ERROR_OF_MEAN|107.386|||TWO_SIDED|90.0|74.57|94.47|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.||94.47|74.57|
91777800|NCT00871975|183437129|SUPERIORITY_OR_OTHER||Specificity (percent)|28.1|||||TWO_SIDED||||||||We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
91777801|NCT01436149|183437130|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.96||0.883|TWO_SIDED|95.0|-1.7|2.0|||Mixed- effects Model for Repeat Measures|||||2.0|-1.7|0.883
91777802|NCT01436149|183437131|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.69||0.576|TWO_SIDED|95.0|-1.8|1.0|||Mixed- effects Model for Repeat Measures|||||1.0|-1.8|0.576
91777803|NCT01409707|183437156|SUPERIORITY_OR_OTHER||||||=|0.068||95.0||||The a priori threshold for statistical significance was set at p = .05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.||||=.068
91777804|NCT01409707|183437157|SUPERIORITY_OR_OTHER||||||=|0.39||95.0||||The a priori threshold for statistical significance was set at p=.05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.||||= 0.39
91777805|NCT00632229|183437158|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
91777806|NCT00632229|183437159|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
91777807|NCT05810740|183437170|OTHER||LS-Mean Ratio, Percent|96.43|||||TWO_SIDED|90.0|92.57|100.46||||||||100.46|92.57|
91777808|NCT05810740|183437171|OTHER||Geometric Mean Ratio|97.19|||||TWO_SIDED|90.0|93.47|101.06||||||||101.06|93.47|
91777809|NCT05810740|183437172|OTHER||Geometric Mean Ratio|94.02|||||TWO_SIDED|90.0|87.25|101.33||||||||101.33|87.25|
91777810|NCT00737672|183437214|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|||||||0.530
91777811|NCT00737672|183437217|SUPERIORITY_OR_OTHER|||||||0.475|||||||Log Rank|||||||0.475
91777812|NCT00737672|183437220|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data.|Log Rank|||||||0.008
91777813|NCT00737672|183437221|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test of non-inferior proportions with delta = 0.15.|||||<|0.001|||||||Z-test|One-sided.||||||<0.001
91777814|NCT00737672|183437222|SUPERIORITY_OR_OTHER|||||||0.035|||||||Log Rank|||||||0.035
91777815|NCT00737672|183437225|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-tailed.||||||1.000
91777816|NCT00737672|183437226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
91777817|NCT00737672|183437227|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
91777818|NCT02735863|183437236|SUPERIORITY|||||||0.5352|||||||Log Rank|||||||0.5352
91777819|NCT05452486|183437237|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|-3.89|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Dichotic digits comparison||||<0.01
91777820|NCT05452486|183437237|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|5.18||||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dichotic words comparison||||0.69
91777821|NCT05720897|183437291|SUPERIORITY|||||||0.399||||||The calculations are based on a Mann Whitney calculation.|Wilcoxon (Mann-Whitney)|||The study has an 80% power to detect changes in patient's self-reported anxiety as measured by their responses to the psychometrically validated STAI-S \& T instrument of 3.6 within each group (with an effect size of 0.55) and differences of a 5.0 between groups (with an effect size of 0.77).||||.399
91583911|NCT00690820|183057957|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.023
91583912|NCT00968227|183058060|SUPERIORITY|Paired t-test||||||0.001|||||||t-test, 2 sided|||||||0.001
91583913|NCT01691768|183058072|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-1.16|0.21||||Univariate Linear Mixed Models were used to analyze primary outcome.|The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.|Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.|The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.|0.21|-1.16|
91583914|NCT01691768|183058072|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)|Median Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.98|0.48||||Univariable Linear Mixed Models was used for the analyses|We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.|This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).||0.48|-0.98|
91583915|NCT01691768|183058073|SUPERIORITY||Incidence rate ratio|0.96||||0.928|TWO_SIDED|95.0|0.4|2.35|||z-test|We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.|The power was not calculated for all the secondary outcomes.||2.35|0.40|0.928
91583916|NCT01691768|183058074|SUPERIORITY||incidence rate ratio|0.96||||0.895|TWO_SIDED|95.0|0.45|2.04|||z-test|We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.|Power was not calculated for all the secondary outcomes.||2.04|0.45|0.895
91583917|NCT01691768|183058075|SUPERIORITY||Risk Ratio (RR)|1.08||||0.304|TWO_SIDED|95.0|0.94|1.24|||Regression, Log-binomial|||Power was not calculated for all secondary outcomes.||1.24|0.94|0.304
91583918|NCT01691768|183058076|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||||||0.455
91583919|NCT01691768|183058078|SUPERIORITY||incidence rate ratio|0.33||||0.097|TWO_SIDED|95.0|0.06|1.32|||z-test||We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.|||1.32|0.06|0.097
91583920|NCT01691768|183058079|SUPERIORITY||Risk Ratio (RR)|0.91||||0.462|TWO_SIDED|95.0|0.7|1.18|||Regression, Log-binomial|||||1.18|0.70|0.462
91646714|NCT01682512|183185166|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.87|STANDARD_ERROR_OF_MEAN|106.608|||TWO_SIDED|90.0|86.21|106.62|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.||106.62|86.21|
91583921|NCT02481947|183058117|NON_INFERIORITY|Non-inferiority margin = 12.6% (pre-specified)||||||0.016||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||||||0.016
91583922|NCT02751320|183058118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.7603|TWO_SIDED|95.0|-8.11|5.94||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||5.94|-8.11|0.7603
91583923|NCT02751320|183058118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.3555|TWO_SIDED|95.0|-10.34|3.74||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||3.74|-10.34|0.3555
91583924|NCT02751320|183058118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21||||0.5335|TWO_SIDED|95.0|-4.81|9.23||ANCOVA: Participant (random), treatment \& period (fixed), Participant-level baseline SMH, period-level baseline SMH, Participant-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates)|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||9.23|-4.81|0.5335
91708401|NCT03299101|183309716|SUPERIORITY|||||||0.814|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.||||0.814
91646715|NCT01682512|183185166|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.46|STANDARD_ERROR_OF_MEAN|106.775|||TWO_SIDED|90.0|80.23|99.74|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.||99.74|80.23|
91777822|NCT00400179|183437297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3952||95.0|||||Fisher Exact|||||||0.3952
91777823|NCT00400179|183437298|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0808|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0808
91777824|NCT00400179|183437299|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9158|TWO_SIDED|95.0|0.86|1.14|||Log Rank|||||1.14|0.86|0.9158
91777825|NCT00400179|183437300|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.032|TWO_SIDED|95.0|0.77|0.99|||Log Rank|||||0.99|0.77|0.0320
91777826|NCT00400179|183437301|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.1983|TWO_SIDED|95.0|0.8|1.05|||Log Rank|||||1.05|0.80|0.1983
91583925|NCT02751320|183058118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.96|||<|0.0001|TWO_SIDED|95.0|16.02|29.9||From ANCOVA: Participant (random), treatment \& period (fixed), Participant -level baseline SMH, period-level baseline SMH, Participant -level pre-treatment acidchallenge SMH and period-level pre-treatment acid challenge SMH (covariates) .|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|Treatment comparison corresponding to qualifying criteria for the analysis||29.90|16.02|<.0001
91583926|NCT01809002|183058131|NON_INFERIORITY|The primary endpoint tested non-inferiority as compared to collagen nerve cuff and superior to no treatment. Non-inferiority is defined as the lower limit of the 95% CI about the difference of \> -2 and the upper limit of the 95% CI for s2PD for Avance of \< 13 in ITT table.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.087|1.574|||ANCOVA|||The analysis was performed using a pre-defined standard statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.||1.574|-1.087|
91583927|NCT01809002|183058132|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||||||0.035
91583928|NCT01809002|183058132|SUPERIORITY|||||||0.365|||||||Wilcoxon (Mann-Whitney)|||||||0.365
91583929|NCT01809002|183058133|SUPERIORITY|||||||0.915||||||The number and percentage of all treated subjects who recovered s2PD in the target repair at Month 12 (i.e., s2PD of 2 - 15 mm) were summarized by repair type. Differences between the repair types were assessed using a logistic regression analysis.|Regression, Logistic|||Responders were defined as subjects achieving s2PD of 2-15 mm on the target nerve repair.||||0.915
91583930|NCT01809002|183058134|SUPERIORITY||LS Means difference|-2.84|||||TWO_SIDED|95.0|-11.6316|5.9541||Pre-injury baseline was defined as s2PD in the contralateral digit associated with the target digit.|ANCOVA|This analysis was assessed in the ITT population, at Month 12 using the LS Mean differences from a repeated measures ANCOVA model.||||5.9541|-11.6316|
91583931|NCT01809002|183058135|SUPERIORITY|||||||0.792|||||||Kaplan-Meier median and 95% CI|Differences between the repair types were assessed with a KM log-rank test that was appropriate for the handing of interval-censored data.||||||0.792
91583932|NCT01809002|183058136|SUPERIORITY|||||||0.526|||||||Wilcoxon (Mann-Whitney)|This analysis was completed to detect a distribution shift of the MRCC score between repairs with PNA and repairs with nerve cuff at Month 12.||||||0.526
91583933|NCT01809002|183058137|OTHER||Mean Difference (Final Values)|-24.09|||||TWO_SIDED|||||||||"This analysis compares the change in 12 Month Pain VAS scores from Baseline. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.~This analysis assesses each treatment group for clinically meaningful improvement in VAS from Baseline assuming a Meaningful Clinically Important Difference delta of 20 points (mm)."||||
91583934|NCT01809002|183058139|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91583935|NCT01809002|183058140|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|This analysis was completed utilizing a one-sided Wilcoxon Rank Sum test.||||||0.037
91646716|NCT01682512|183185166|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.31|STANDARD_ERROR_OF_MEAN|105.7|||TWO_SIDED|90.0|85.11|102.29|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.||102.29|85.11|
91583936|NCT01809002|183058141|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|One-sided Wilcoxon Rank Sum test was utilized for this analysis.||||||0.021
91583937|NCT01886378|183058164|SUPERIORITY||Least squares (LS) mean|423.594||||0.1518|TWO_SIDED|95.0|-155.66|1002.85||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% confidence interval (CI), and p-values are based on the GEE model.|||1002.85|-155.66|0.1518
91583938|NCT01886378|183058165|SUPERIORITY||LS mean|-0.011||||0.3964|TWO_SIDED|95.0|-0.04|0.01||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||0.01|-0.04|0.3964
91583939|NCT01886378|183058166|SUPERIORITY||LS mean|4.671||||0.0777|TWO_SIDED|95.0|-0.52|9.86||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||9.86|-0.52|0.0777
91777827|NCT04780061|183437302|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||An area under the curve approach was used to analyze the primary outcome, whereby participants' scores for each assessment were summed over the 21-day period. For missing values, we imputed the mean of the most recent and first subsequent measurement or carried the last observation forward if there was no subsequent measurement.||||0.53
91777828|NCT04780061|183437304|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91777829|NCT04780061|183437305|SUPERIORITY|||||||0.81|||||||Log Rank|||||||0.81
91777830|NCT02344108|183437311|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91777831|NCT02344108|183437312|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91583940|NCT01886378|183058167|SUPERIORITY||LS mean|181.37||||0.083|TWO_SIDED|95.0|-23.7|386.45||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||386.45|-23.70|0.0830
91646717|NCT01682512|183185167|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.97|STANDARD_ERROR_OF_MEAN|105.995|||TWO_SIDED|90.0|85.32|103.5|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.||103.50|85.32|
91777832|NCT02344108|183437313|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91777833|NCT02344108|183437314|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
91777834|NCT02344108|183437315|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
91777835|NCT02344108|183437316|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
91777836|NCT02344108|183437317|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91777837|NCT02344108|183437318|SUPERIORITY|||||||0.467|||||||t-test, 2 sided|||||||0.467
91777838|NCT02344108|183437319|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
91777839|NCT02344108|183437320|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
91777840|NCT02344108|183437321|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91777841|NCT02344108|183437322|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91777842|NCT02344108|183437323|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91777843|NCT04050553|183437324|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.7556|TWO_SIDED|95.0|-3.64|2.67|||Mixed Models Analysis|||||2.67|-3.64|0.7556
91777844|NCT04050553|183437325|SUPERIORITY||LS Mean Difference|-174.77||||0.0043|TWO_SIDED|95.0|-290.34|-59.21|||Mixed Models Analysis|||||-59.21|-290.34|0.0043
91777845|NCT04050553|183437326|SUPERIORITY||LS Mean Difference|-488.31|||<|0.0001|TWO_SIDED|95.0|-621.25|-355.36|||Mixed Models Analysis|||||-355.36|-621.25|<0.0001
91777846|NCT04050553|183437327|SUPERIORITY||LS Mean Difference|4.39||||0.0023|TWO_SIDED|95.0|1.69|7.08|||Mixed Models Analysis|||||7.08|1.69|0.0023
91583941|NCT01886378|183058168|SUPERIORITY||LS mean|-0.185||||0.032|TWO_SIDED|95.0|-0.35|-0.02||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||-0.02|-0.35|0.0320
91583942|NCT01886378|183058169|SUPERIORITY||LS mean|12.44||||0.085|TWO_SIDED|95.0|-1.72|26.6||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||26.60|-1.72|0.0850
91583943|NCT01886378|183058170|SUPERIORITY||LS mean|2.16||||0.3754|TWO_SIDED|95.0|-2.62|6.94||The LS Mean, standard error (SE), 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||6.94|-2.62|0.3754
91583944|NCT01886378|183058171|SUPERIORITY||LS mean|0.816||||0.7564|TWO_SIDED|95.0|-4.34|5.97||The LS Mean, SE, 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||5.97|-4.34|0.7564
91583945|NCT01886378|183058172|SUPERIORITY||LS mean|8.88|||<|0.0001|TWO_SIDED|95.0|5.67|12.08||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model|||||12.08|5.67|<0.0001
91583946|NCT01886378|183058173|SUPERIORITY||LS mean|9.7||||0.0152|TWO_SIDED|95.0|1.87|17.54||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||17.54|1.87|0.0152
91583947|NCT02411357|183058225|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Chi-square trend test|||||||<.001
91583948|NCT02858349|183058270|SUPERIORITY||Mean Difference (Net)|0.13||||0.0042|TWO_SIDED|95.0|0.05|0.21|||Mixed Models Analysis|||||0.21|0.05|0.0042
91646718|NCT01682512|183185167|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.3|STANDARD_ERROR_OF_MEAN|105.657|||TWO_SIDED|90.0|81.51|97.83|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.||97.83|81.51|
91777847|NCT04050553|183437328|SUPERIORITY||LS Mean Difference|-0.06||||0.0505|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 100 mg/dL.||0.00|-0.13|0.0505
91583949|NCT04217590|183058282|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|1.9|15.12|||Fisher Exact||The CI for OR is calculated as an exact CI. An OR \> 1 favours SZC.|||15.12|1.90|<0.001
91583950|NCT04217590|183058283|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.64|15.55|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.55|2.64|<0.001
91583951|NCT04217590|183058284|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.71|15.12|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.12|2.71|<0.001
91583952|NCT04217590|183058285|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.53|7.67|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||7.67|2.53|<0.001
91583953|NCT04217590|183058286|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.77|1.64|||||Endpoint analysed with Generalised linear mixed model. The CI for the mean difference was calculated by bootstrapping. A mean difference \> 0 favours SZC.|||1.64|0.77|
91583954|NCT04217590|183058287|SUPERIORITY||Odds Ratio (OR)|5.82|||<|0.001|TWO_SIDED|95.0|3.15|10.73|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||10.73|3.15|<0.001
91777848|NCT04050553|183437328|SUPERIORITY||LS Mean Difference|-0.18||||0.0104|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 63 mg/dL.||-0.05|-0.31|0.0104
91583955|NCT00704405|183058300|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|53.6|||<|0.001|TWO_SIDED|95.0|34.5|69.1|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||69.1|34.5|<0.001
91583956|NCT00704405|183058300|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|64.4|||<|0.001|TWO_SIDED|95.0|45.2|78.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||78.3|45.2|<0.001
91777849|NCT04050553|183437328|SUPERIORITY||LS Mean Difference|-0.19||||0.0068|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 45 mg/dL.||-0.06|-0.32|0.0068
91777850|NCT04050553|183437328|SUPERIORITY||LS Mean Difference|-0.11||||0.2302|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 72 mg/dL.||0.08|-0.30|0.2302
91777851|NCT04050553|183437329|SUPERIORITY||LS Mean Difference|-0.51||||0.8298|TWO_SIDED|95.0|-5.28|4.27|||Mixed Models Analysis|||For systolic blood pressure.||4.27|-5.28|0.8298
91777852|NCT04050553|183437329|SUPERIORITY||LS Mean Difference|1.96||||0.1516|TWO_SIDED|95.0|-0.76|4.67|||Mixed Models Analysis|||For diastolic blood pressure.||4.67|-0.76|0.1516
91777853|NCT04050553|183437330|SUPERIORITY||LS Mean Difference|-0.89||||0.5776|TWO_SIDED|95.0|-4.1|2.33|||Mixed Models Analysis|||||2.33|-4.10|0.5776
91777854|NCT00498940|183437335|SUPERIORITY_OR_OTHER|||||||0.14||||||Differences in cardiac index between groups were assessed by an independent 2-sample t test.|t-test, 2 sided|||||||.14
91777855|NCT03589859|183437380|OTHER|This was a physiology study, not a treatment trial. The test was for a change in VOR gain.|||||<|0.001|||||||Mixed Models Analysis|||A linear mixed effects model was used to compare pre- and post-training VOR gains||||<0.001
91777856|NCT00626106|183437396|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.542|TWO_SIDED|95.0|-0.11|0.07|||ANCOVA|||||0.07|-0.11|0.542
91777857|NCT02201953|183437411|NON_INFERIORITY_OR_EQUIVALENCE|Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)|Difference in proportions|14.4|||||TWO_SIDED|95.0|9.2|19.6|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||19.6|9.2|
91777858|NCT02201953|183437411|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.|Cochran-Mantel-Haenszel|||If the lower bound of 95% CI on the difference was \> -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.||||<0.001
91777859|NCT01298648|183437436|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed cases at Baseline and Week 4.||||||<0.0001
91777860|NCT01298648|183437438|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|Paired t-test using observed values at Baseline and Week 8.||||||<0.0001
91777861|NCT01298648|183437439|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed values at Baseline and Week 24.||||||<0.0001
91777862|NCT00918255|183437467|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.022
91777863|NCT00918255|183437467|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.025
91777864|NCT00918255|183437467|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.252
91777865|NCT00918255|183437468|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|ANCOVA|||||||0.062
91777866|NCT00918255|183437468|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.019
91777867|NCT00918255|183437468|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.286
91777868|NCT00918255|183437469|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
91777869|NCT00918255|183437469|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
91777870|NCT00918255|183437469|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.097
91777871|NCT00918255|183437470|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.044
91777872|NCT00918255|183437470|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.051
91777873|NCT00918255|183437470|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.320
91777874|NCT00918255|183437471|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
91777875|NCT00918255|183437471|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
91777876|NCT00918255|183437471|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.673
91777877|NCT00918255|183437472|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.012
91777878|NCT00918255|183437472|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.020
91777879|NCT00918255|183437472|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.721
91777880|NCT00918255|183437473|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Van Elteren test|||||||0.045
91777881|NCT00918255|183437473|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.014
91777882|NCT00918255|183437473|SUPERIORITY_OR_OTHER|||||||0.169||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.169
91777883|NCT01116986|183437484|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.312|TWO_SIDED|95.0|0.871|1.045|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.045|.871|.312
91646719|NCT01682512|183185167|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.02|STANDARD_ERROR_OF_MEAN|105.744|||TWO_SIDED|90.0|86.62|104.25|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.||104.25|86.62|
91646720|NCT01682512|183185169|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|104.49|STANDARD_ERROR_OF_MEAN|108.044|||TWO_SIDED|90.0|91.92|118.78|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.||118.78|91.92|
91646721|NCT01682512|183185169|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|91.39|STANDARD_ERROR_OF_MEAN|107.253|||TWO_SIDED|90.0|81.38|102.64|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.||102.64|81.38|
91646722|NCT01682512|183185169|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|87.47|STANDARD_ERROR_OF_MEAN|107.896|||TWO_SIDED|90.0|77.12|99.21|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.||99.21|77.12|
91646723|NCT00417027|183185174|SUPERIORITY_OR_OTHER||||||>|0.05||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||>0.05
91646724|NCT00417027|183185174|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.005
91646725|NCT00417027|183185174|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
91646726|NCT00417027|183185175|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Kruskal-Wallis|||||||0.54
91646727|NCT00417027|183185176|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Kruskal-Wallis|||||||0.32
91646728|NCT00417027|183185177|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||0.69
91646729|NCT00417027|183185178|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Analysis applies to all rows.|Chi-squared, Corrected|||Analysis apply to all rows. Only 1 comparison was made between the groups in distribution of number of bolus doses.||||0.72
91646730|NCT00417027|183185179|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Kruskal-Wallis|||||||0.41
91646731|NCT00417027|183185180|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Kruskal-Wallis|||||||0.85
91646732|NCT03137082|183185181|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<0.03
91646733|NCT03137082|183185182|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
91583957|NCT00704405|183058300|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|59.0|||<|0.001|TWO_SIDED|95.0|40.2|73.4|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||73.4|40.2|<0.001
91646734|NCT03137082|183185184|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91646735|NCT03137082|183185185|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91646736|NCT03137082|183185186|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
91646737|NCT03137082|183185187|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<.03
91646738|NCT03137082|183185188|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
91646739|NCT03137082|183185189|SUPERIORITY||||||<|0.3|||||||Mixed Models Analysis|||||||<0.3
91646740|NCT03137082|183185190|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
91646741|NCT03137082|183185191|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.4
91646742|NCT03137082|183185192|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91646743|NCT03137082|183185193|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
91646744|NCT02787785|183185194|SUPERIORITY||Cox Proportional Hazard|0.49||||0.354|TWO_SIDED|95.0|0.11|2.2|||Regression, Cox|||||2.20|0.11|0.354
91646745|NCT02787785|183185196|SUPERIORITY||Cox Proportional Hazard|0.37||||0.479|TWO_SIDED|95.0|0.02|5.88|||Regression, Cox|||||5.88|0.02|0.479
91646746|NCT01447628|183185220|SUPERIORITY|||||||0.6039|||||||Mixed Models Analysis|||||||0.6039
91646747|NCT01447628|183185221|SUPERIORITY|||||||0.0747|||||||Mixed Models Analysis|||||||0.0747
91646748|NCT01447628|183185221|SUPERIORITY|||||||0.799|||||||Mixed Models Analysis|||||||0.7990
91646749|NCT01447628|183185221|SUPERIORITY|||||||0.2111|||||||Mixed Models Analysis|||This is a combination of the p-values from the separate analyses of each data set.||||0.2111
91646750|NCT01447628|183185222|SUPERIORITY|||||||0.6583|||||||Mixed Models Analysis|||||||0.6583
91646751|NCT01447628|183185222|SUPERIORITY|||||||0.9166|||||||Mixed Models Analysis|||||||0.9166
91646752|NCT01447628|183185222|SUPERIORITY|||||||0.6631|||||||Mixed Models Analysis|||||||0.6631
91646753|NCT01447628|183185223|SUPERIORITY|||||||0.4039|||||||Mixed Models Analysis|||||||0.4039
91646754|NCT01447628|183185223|SUPERIORITY|||||||0.9144|||||||Mixed Models Analysis|||||||0.9144
91646755|NCT01447628|183185223|SUPERIORITY|||||||0.9959|||||||Mixed Models Analysis|||||||0.9959
91646756|NCT01447628|183185224|SUPERIORITY|||||||0.1788|||||||Mixed Models Analysis|||||||0.1788
91646757|NCT01447628|183185224|SUPERIORITY|||||||0.7795|||||||Mixed Models Analysis|||||||0.7795
91646758|NCT01447628|183185224|SUPERIORITY|||||||0.414|||||||Mixed Models Analysis|||||||0.414
91583958|NCT00704405|183058303|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|47.3|||<|0.001|TWO_SIDED|95.0|29.2|63.2|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||63.2|29.2|<0.001
91583959|NCT00704405|183058304|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|82.6|||||TWO_SIDED|95.0|69.5|90.2|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||90.2|69.5|
91646759|NCT01447628|183185225|SUPERIORITY|||||||0.8688|||||||Mixed Models Analysis|||||||0.8688
91646760|NCT01447628|183185225|SUPERIORITY|||||||0.9999|||||||Mixed Models Analysis|||||||0.9999
91646761|NCT01447628|183185225|SUPERIORITY|||||||0.991|||||||Mixed Models Analysis|||||||0.991
91646762|NCT01447628|183185226|SUPERIORITY|||||||0.5465|||||||Mixed Models Analysis|||||||0.5465
91646763|NCT01447628|183185226|SUPERIORITY|||||||0.4298|||||||Mixed Models Analysis|||||||0.4298
91583960|NCT00704405|183058304|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|76.1|||||TWO_SIDED|95.0|60.1|86.7|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||86.7|60.1|
91583961|NCT00704405|183058305|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|35.8|||||TWO_SIDED|95.0|15.5|53.4|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.|||53.4|15.5|
91646764|NCT01447628|183185226|SUPERIORITY|||||||0.5451|||||||Mixed Models Analysis|||||||0.5451
91583962|NCT01395888|183058306|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259||||0.484|TWO_SIDED|95.0|-0.468|0.986|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.986|-0.468|0.484
91583963|NCT02641496|183058326|OTHER|ANOVA||||||0.027||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Treatment 1 to Treatment 4 (approximately first 30 days of treatment)||||0.027
91646765|NCT01447628|183185227|SUPERIORITY|||||||0.6241|||||||Mixed Models Analysis|||Note that Endurance CPET was not done in China, hence only European data provided.||||0.6241
91646766|NCT01447628|183185228|SUPERIORITY|||||||0.4758|||||||Mixed Models Analysis|||||||0.4758
91777884|NCT01116986|183437484|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.664|TWO_SIDED|95.0|0.894|1.074|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.074|.894|.664
91777885|NCT01116986|183437484|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.989||||0.814|TWO_SIDED|95.0|0.903|1.084|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.084|.903|.814
91646767|NCT01447628|183185229|SUPERIORITY|||||||0.205|||||||Mixed Models Analysis|||||||0.2050
91646768|NCT01447628|183185229|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
91646769|NCT01447628|183185229|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
91583964|NCT02641496|183058326|OTHER|ANOVA||||||0.919||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Last 30 Days of 1 Year Study||||0.919
91583965|NCT02641496|183058327|OTHER|||||||0.696||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.696
91583966|NCT02641496|183058328|OTHER|||||||0.593||||||Significance threshold p\<0.05; two-tailed|ANOVA|||||||0.593
91583967|NCT02641496|183058329|OTHER|||||||0.925||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.925
91583968|NCT02112838|183058343|SUPERIORITY||Mean Difference (Final Values)|19.9||||0.97|TWO_SIDED|95.0|-910.6|950.5|||ANCOVA|||||950.5|-910.6|0.97
91646770|NCT01447628|183185230|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.0610
91646771|NCT01447628|183185230|SUPERIORITY|||||||0.0641|||||||Mixed Models Analysis|||||||0.0641
91646772|NCT01447628|183185231|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
91646773|NCT01447628|183185231|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
91646774|NCT01447628|183185231|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91646775|NCT01447628|183185232|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91646776|NCT01447628|183185233|SUPERIORITY|||||||0.8093|||||||Mixed Models Analysis|||||||0.8093
91646777|NCT01447628|183185233|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|||||||0.6300
91646778|NCT01447628|183185233|SUPERIORITY|||||||0.8533|||||||Mixed Models Analysis|||||||0.8533
91646779|NCT01447628|183185234|SUPERIORITY|||||||0.0725|||||||Mixed Models Analysis|||||||0.0725
91646780|NCT01447628|183185234|SUPERIORITY|||||||0.8572|||||||Mixed Models Analysis|||||||0.8572
91646781|NCT01447628|183185234|SUPERIORITY|||||||0.2348|||||||Mixed Models Analysis|||||||0.2348
91646782|NCT01447628|183185235|SUPERIORITY|||||||0.1115|||||||Mixed Models Analysis|||||||0.1115
91646783|NCT01447628|183185236|SUPERIORITY|||||||0.979|||||||Mixed Models Analysis|||||||0.9790
91646784|NCT01447628|183185237|SUPERIORITY|||||||0.7702|||||||Mixed Models Analysis|||||||0.7702
91646785|NCT01447628|183185238|SUPERIORITY|||||||0.2219|||||||Mixed Models Analysis|||||||0.2219
91646786|NCT01447628|183185239|SUPERIORITY|||||||0.1777|||||||Mixed Models Analysis|||||||0.1777
91646787|NCT01447628|183185239|SUPERIORITY|||||||0.7889|||||||Mixed Models Analysis|||||||0.7889
91646788|NCT01447628|183185239|SUPERIORITY|||||||0.4156|||||||Mixed Models Analysis|||||||0.4156
91646789|NCT01447628|183185240|SUPERIORITY|||||||0.7625|||||||Mixed Models Analysis|||||||0.7625
91583969|NCT02112838|183058343|SUPERIORITY||Mean Difference (Final Values)|-399.7||||0.4|TWO_SIDED|95.0|-1320.8|521.3|||ANCOVA|||||521.3|-1320.8|0.40
91583970|NCT01912456|183058415|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
91583971|NCT01912456|183058415|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
91646790|NCT01447628|183185240|SUPERIORITY|||||||0.2262|||||||Mixed Models Analysis|||||||0.2262
91583972|NCT01912456|183058415|OTHER||||||=|0.114|||||||Mixed Models Analysis|||||||= 0.114
91583973|NCT01912456|183058416|OTHER||difference in percentages of responder|13.8|||||TWO_SIDED|95.0|-2.8|29.7||||||||29.7|-2.8|
91583974|NCT01912456|183058417|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
91583975|NCT01912456|183058417|OTHER||||||=|0.018|||||||Mixed Models Analysis|||||||= 0.018
91583976|NCT01912456|183058417|OTHER||||||=|0.31|||||||Mixed Models Analysis|||||||= 0.31
91583977|NCT01340196|183058422|SUPERIORITY_OR_OTHER||Geometric mean ratio|121.89|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|111.714|132.999|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|||132.999|111.714|
91583978|NCT01340196|183058423|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.72|STANDARD_DEVIATION|17.2|||TWO_SIDED|90.0|85.215|105.29|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||105.290|85.215|
91646791|NCT01447628|183185240|SUPERIORITY|||||||0.4756|||||||Mixed Models Analysis|||||||0.4756
91646792|NCT01447628|183185241|SUPERIORITY|||||||0.7711|||||||Mixed Models Analysis|||||||0.7711
91583979|NCT01340196|183058424|SUPERIORITY_OR_OTHER||Geometric mean ratio|147.12|STANDARD_DEVIATION|14.6||||90.0|134.482|160.943|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||160.943|134.482|
91583980|NCT01340196|183058425|SUPERIORITY_OR_OTHER||Geometric mean ratio|77.88|STANDARD_DEVIATION|13.4|||TWO_SIDED|90.0|71.24|85.15|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||85.15|71.24|
91583981|NCT01340196|183058426|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.73|STANDARD_DEVIATION|20.1|||TWO_SIDED|90.0|71.56|93.34|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||93.34|71.56|
91646793|NCT01447628|183185241|SUPERIORITY|||||||0.7806|||||||Mixed Models Analysis|||||||0.7806
91646794|NCT01447628|183185241|SUPERIORITY|||||||0.9074|||||||Mixed Models Analysis|||||||0.9074
91646795|NCT01447628|183185242|SUPERIORITY|||||||0.9504|||||||Mixed Models Analysis|||||||0.9504
91646796|NCT01447628|183185242|SUPERIORITY|||||||0.8666|||||||Mixed Models Analysis|||||||0.8666
91646797|NCT01447628|183185242|SUPERIORITY|||||||0.8104|||||||Mixed Models Analysis|||||||0.8104
91646798|NCT01447628|183185243|SUPERIORITY|||||||0.4478|||||||Mixed Models Analysis|||||||0.4478
91646799|NCT01447628|183185244|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||||||0.4590
91646800|NCT01447628|183185245|SUPERIORITY|||||||0.8086|||||||Mixed Models Analysis|||||||0.8086
91583982|NCT01340196|183058427|SUPERIORITY_OR_OTHER||Geometric mean ratio|75.27|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|68.71|82.45|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||82.45|68.71|
91583983|NCT00320541|183058447|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance at 0.05 level was required.|Fisher Exact|||Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.||||0.117
91583984|NCT00320541|183058448|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Log Rank|||||||0.247
91583985|NCT00320541|183058449|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||Log Rank|||||||0.475
91646801|NCT01447628|183185246|SUPERIORITY|||||||0.6944|||||||Mixed Models Analysis|||||||0.6944
91646802|NCT01447628|183185247|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|||||||0.585
91646803|NCT01447628|183185248|SUPERIORITY|||||||0.4619|||||||Mixed Models Analysis|||||||0.4619
91646804|NCT01447628|183185249|SUPERIORITY|||||||0.7721|||||||Mixed Models Analysis|||||||0.7721
91777886|NCT01116986|183437484|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.925||||0.093|TWO_SIDED|95.0|0.844|1.013|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.013|.844|.093
91777887|NCT01116986|183437484|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983||||0.716|TWO_SIDED|95.0|0.898|1.077|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.077|.898|.716
91777888|NCT01116986|183437484|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.031||||0.511|TWO_SIDED|95.0|0.941|1.13|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.130|.941|.511
91777889|NCT01116986|183437485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||0.341|TWO_SIDED|95.0|0.916|1.29|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.||1.290|.916|.341
91777890|NCT01116986|183437485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.207|TWO_SIDED|95.0|0.941|1.325|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.325|.941|.207
91777891|NCT01116986|183437485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.196||||0.041|TWO_SIDED|95.0|1.008|1.42|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.420|1.008|.041
91777892|NCT01116986|183437485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.056||||0.536|TWO_SIDED|95.0|0.889|1.254|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.254|.889|.536
91583986|NCT00320541|183058450|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.010
91583987|NCT00320541|183058451|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.119
91583988|NCT00320541|183058452|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.023
91583989|NCT00320541|183058453|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.002
91583990|NCT00320541|183058454|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.004
91583991|NCT00320541|183058455|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.067
91583992|NCT00320541|183058456|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.036
91583993|NCT01097785|183058457|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
91583994|NCT01097785|183058458|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
91646805|NCT01447628|183185250|SUPERIORITY|||||||0.8332|||||||Mixed Models Analysis|||||||0.8332
91646806|NCT01447628|183185251|SUPERIORITY|||||||0.2651|||||||Mixed Models Analysis|||||||0.2651
91708402|NCT03299101|183309716|SUPERIORITY||Mean Difference (Net)|10.5|STANDARD_ERROR_OF_MEAN|30.91||0.734|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.||||0.734
91777893|NCT01116986|183437485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.587|TWO_SIDED|95.0|0.883|1.246|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.246|.883|.587
91583995|NCT05062759|183058470|OTHER||Geometric Least square (LS) mean ratio|0.65|||||TWO_SIDED|90.0|0.43|0.98||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model.||0.98|0.43|
91583996|NCT05062759|183058470|OTHER||Geometeric LS mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.15|0.60|
91583997|NCT05062759|183058470|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.71|1.37||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.37|0.71|
91583998|NCT05062759|183058471|OTHER||Geometeric LS mean ratio|0.73|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
91583999|NCT05062759|183058471|OTHER||Geometeric LS mean ratio|1.25|||||TWO_SIDED|90.0|0.72|2.17||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.17|0.72|
91584000|NCT05062759|183058471|OTHER||Geometric LS mean ratio|1.23|||||TWO_SIDED|90.0|0.73|2.07||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.07|0.73|
91584001|NCT05062759|183058471|OTHER||Geometeric LS mean ratio|0.89|||||TWO_SIDED|90.0|0.54|1.48||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.48|0.54|
91584002|NCT05062759|183058472|OTHER||Geometeric LS mean ratio|0.74|||||TWO_SIDED|90.0|0.52|1.04||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.04|0.52|
91584003|NCT05062759|183058472|OTHER||Geometeric LS mean ratio|0.96|||||TWO_SIDED|90.0|0.72|1.29||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.29|0.72|
91584004|NCT05062759|183058472|OTHER||Geometric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.73|1.46||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.46|0.73|
91584005|NCT05062759|183058473|OTHER||Geometeric LS mean ratio|0.79|||||TWO_SIDED|90.0|0.51|1.25||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.25|0.51|
91584006|NCT05062759|183058473|OTHER||Geometeric LS mean ratio|0.76|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
91584007|NCT05062759|183058473|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.49|1.99||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.99|0.49|
91777894|NCT01116986|183437485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.389|TWO_SIDED|95.0|0.909|1.278|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.278|.909|.389
91777895|NCT02392624|183437499|SUPERIORITY||Clinical Worsening Rate Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-54.5|-22.5|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-22.5|-54.5|<0.0001
91777896|NCT02392624|183437500|SUPERIORITY||||||<|0.0001|||||||Log Rank|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||||<0.0001
91584008|NCT05062759|183058473|OTHER||Geometeric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.7|1.52||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.52|0.70|
91584009|NCT01122862|183058487|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.0915|TWO_SIDED|95.0|-0.45|0.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.03|-0.45|0.0915
91584010|NCT01122862|183058488|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference in treatments being compared.||1.90|1.42|<0.0001
91584011|NCT01122862|183058489|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.6682|TWO_SIDED|95.0|-0.14|0.21|||ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.21|-0.14|0.6682
91584012|NCT01122862|183058489|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.74|||<|0.0001|TWO_SIDED|95.0|0.57|0.92||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.92|0.57|<0.0001
91584013|NCT01122862|183058490|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2||||0.11|TWO_SIDED|95.0|-0.44|0.05||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.05|-0.44|0.1100
91777897|NCT02392624|183437501|SUPERIORITY||Clinical Worsening Rate Difference|-32.1||||0.0004|TWO_SIDED|95.0|-47.9|-14.9|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-14.9|-47.9|0.0004
91584014|NCT01122862|183058490|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.68|||<|0.0001|TWO_SIDED|95.0|1.44|1.93||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.93|1.44|<0.0001
91584015|NCT01122862|183058491|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.728||95.0|-0.16|0.23||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.23|-0.16|0.7280
91584016|NCT01122862|183058491|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.88|||<|0.0001|TWO_SIDED|95.0|0.68|1.08||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.08|0.68|<0.0001
91584017|NCT01249274|183058514|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|1.04|1.36|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is the risk ratio estimate for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for the treatment variable.|||1.36|1.04|0.010
91584018|NCT01249274|183058515|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|30.39||||0.003|TWO_SIDED|95.0|3.18|290.04|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||290.04|3.18|0.003
91584019|NCT01249274|183058515|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|16.65||||0.038|TWO_SIDED|95.0|1.18|235.52|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction term for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 and 3-month post-trial follow-up. Treatment variable reference group was progesterone.|Negative binomial distribution, log link, and first-order autoregressive covariance structure||235.52|1.18|0.038
91584020|NCT01249274|183058516|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.87|1.15|||Generalized Estimating Equation||Estimated value is the risk ratio for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for treatment.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||1.15|0.87|0.99
91584021|NCT01249274|183058517|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.75|TWO_SIDED|95.0|0.23|7.88|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||7.88|0.23|0.75
91777898|NCT02392624|183437502|OTHER||||||<|0.0001|||||||One-sample t-test, 1 sided|The p-value from this test was used to determine the importance of continued treatment in this study. P-value is one-sided with alpha = 0.05.||The null hypothesis for this test was that the mean change from Week 24 to Week 48 in UAS7 score was \>/=5 and the alternative hypothesis was that the mean change from Week 24 to Week 48 in UAS7 score was \<5.||||<0.0001
91777899|NCT02392624|183437503|OTHER||||||<|0.0001|||||||One-sample t-test, 2 sided|The p-value from this test was used to evaluate the importance of retreatment after experiencing clinical worsening.||The null hypothesis for this test was that the mean change from the time of retreatment to 12 weeks after retreatment in UAS7 was zero and the alternative hypothesis was that this change was non-zero.||||<0.0001
91777900|NCT03841604|183437506|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1695|TWO_SIDED|95.0|-1.75|0.32|||Mixed Model Repeated Measures|||||0.32|-1.75|0.1695
91777901|NCT03841604|183437507|OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.55||0.0784|TWO_SIDED|95.0|-2.1|0.12|||Mixed Model Repeated Measures|||||0.12|-2.1|0.0784
91777902|NCT03841604|183437508|OTHER||Risk Difference (RD)|-0.23||||0.0744|TWO_SIDED|95.0|-0.45|-0.01|||Cochran-Mantel-Haenszel|||||-0.01|-0.45|0.0744
91777903|NCT03841604|183437509|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7247|TWO_SIDED|95.0|-0.7|0.49|||Mixed Model Repeated Measures|||||0.49|-0.70|0.7247
91777904|NCT03841604|183437510|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9052|TWO_SIDED|95.0|-0.43|0.38|||Mixed Model Repeated Measures|||||0.38|-0.43|0.9052
91777905|NCT03841604|183437511|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7115|TWO_SIDED|95.0|-0.61|0.88|||Mixed Model Repeated Measures|||||0.88|-0.61|0.7115
91777906|NCT03841604|183437512|SUPERIORITY||Risk Difference (RD)|0.04||||0.1967|TWO_SIDED|95.0|-0.04|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.04|0.1967
91777907|NCT03841604|183437513|SUPERIORITY||Risk Difference (RD)|0.06||||0.5122|TWO_SIDED|95.0|-0.13|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.13|0.5122
91777908|NCT03841604|183437515|OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.29||0.7376|TWO_SIDED|95.0|-3.03|2.16|||ANCOVA|||||2.16|-3.03|0.7376
91777909|NCT03841604|183437516|OTHER||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|3.92||0.5349|TWO_SIDED|95.0|-10.33|5.43|||Mixed Model Repeated Measures|||||5.43|-10.33|0.5349
91777910|NCT01337960|183437517|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||< 0.01
91777911|NCT01337960|183437518|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||Fisher Exact|||||||<.02
91777912|NCT01337960|183437519|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||Fisher Exact|||||||=0.17
91777913|NCT01337960|183437520|SUPERIORITY_OR_OTHER||||||=|0.35|TWO_SIDED||||||Fisher Exact|||||||=0.35
91777914|NCT03763877|183437552|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|7.926||0.9883|TWO_SIDED|95.0|-15.42|15.66|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||15.66|-15.42|0.9883
91777915|NCT03763877|183437552|SUPERIORITY||Mean Difference (Final Values)|-13.14|STANDARD_ERROR_OF_MEAN|7.609||0.0842|TWO_SIDED|95.0|-28.06|1.78|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.78|-28.06|0.0842
91777916|NCT03763877|183437552|SUPERIORITY||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|7.636||0.0763|TWO_SIDED|95.0|-28.51|1.43|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.43|-28.51|0.0763
91777917|NCT03763877|183437553|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|7.265||0.8283|TWO_SIDED|95.0|-16.01|12.85|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||12.85|-16.01|0.8283
91777918|NCT03763877|183437553|SUPERIORITY||Mean Difference (Final Values)|-13.25|STANDARD_ERROR_OF_MEAN|7.221||0.0698|TWO_SIDED|95.0|-27.6|1.1|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.10|-27.60|0.0698
91777919|NCT03763877|183437553|SUPERIORITY||Mean Difference (Final Values)|-17.31|STANDARD_ERROR_OF_MEAN|7.207||0.0184|TWO_SIDED|95.0|-31.63|-2.99|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||-2.99|-31.63|0.0184
91777920|NCT03763877|183437554|SUPERIORITY||Location Shift|-4.22||||0.5537|TWO_SIDED|95.0|-15.64|8.65|||Wilcoxon (Mann-Whitney)|||||8.65|-15.64|0.5537
91777921|NCT03763877|183437554|SUPERIORITY||Location Shift|-13.64||||0.1005|TWO_SIDED|95.0|-26.19|1.88|||Wilcoxon (Mann-Whitney)|||||1.88|-26.19|0.1005
91777922|NCT03763877|183437554|SUPERIORITY||Location Shift|-18.72||||0.0387|TWO_SIDED|95.0|-31.95|-1.58|||Wilcoxon (Mann-Whitney)|||||-1.58|-31.95|0.0387
91777923|NCT03763877|183437555|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|0.5733||0.5733|TWO_SIDED|95.0|-18.0|32.51|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||32.51|-18.00|0.5733
91777924|NCT03763877|183437555|SUPERIORITY||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|12.236||0.3861|TWO_SIDED|95.0|-34.6|13.38|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||13.38|-34.60|0.3861
91777925|NCT03763877|183437555|SUPERIORITY||Mean Difference (Final Values)|-21.13|STANDARD_ERROR_OF_MEAN|12.916||0.1019|TWO_SIDED|95.0|-46.46|4.19|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||4.19|-46.46|0.1019
91777926|NCT03763877|183437556|SUPERIORITY||Mean Difference (Final Values)|-0.242|STANDARD_ERROR_OF_MEAN|1.3873||0.8617|TWO_SIDED|95.0|-2.961|2.478|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||2.478|-2.961|0.8617
91777927|NCT03763877|183437556|SUPERIORITY||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|1.3712||0.0609|TWO_SIDED|95.0|-5.26|0.117|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|0.117|-5.260|0.0609
91777928|NCT03763877|183437556|SUPERIORITY||Mean Difference (Final Values)|-2.414|STANDARD_ERROR_OF_MEAN|1.3633||0.0766|TWO_SIDED|95.0|-5.087|0.258|||ANCOVA|ANCOVA using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.258|-5.087|0.0766
91777929|NCT03763877|183437557|SUPERIORITY||Odds Ratio (OR)|1.744||||0.5592|TWO_SIDED|95.0|0.27|11.267|||Regression, Logistic|Logistic regression with multiple imputation||||11.267|0.270|0.5592
91777930|NCT03763877|183437557|SUPERIORITY||Odds Ratio (OR)|2.287||||0.3747|TWO_SIDED|95.0|0.368|14.208|||Regression, Logistic|Logistic regression with multiple imputation||||14.208|0.368|0.3747
91777931|NCT03763877|183437557|SUPERIORITY||Odds Ratio (OR)|5.669||||0.0501|TWO_SIDED|95.0|1.0|32.149|||Regression, Logistic|Logistic regression with multiple imputation||||32.149|1.000|0.0501
91521108|NCT02231177|182916982|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32|STANDARD_DEVIATION|96.12|||TWO_SIDED|90.0|0.98|1.77|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg; Olodaterol 10 µg). No formal testing.||1.77|0.98|
91584022|NCT01249274|183058517|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.84|TWO_SIDED|95.0|0.24|5.84|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|||5.84|0.24|0.84
91584023|NCT01249274|183058518|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.1030
91584024|NCT01249274|183058519|SUPERIORITY_OR_OTHER||Score Statistic For Type 3 GEE Analysis|0.01||||0.9116|TWO_SIDED||||||Generalized Estimating Equation|Gamma distribution, logit link, 1st-order autoregressive covariance structure; p-value is for chi-sq (df=1) for type 3 GEE analysis score statistic|Estimated value is chi-sq (df=1) for type 3 GEE analysis score statistic for week\*treatment interaction term.|||||0.9116
91584025|NCT01249274|183058522|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|4.71||||0.048|TWO_SIDED|95.0|1.09|20.5|||Regression, Cox||Ratio presented is for placebo versus progesterone|||20.50|1.09|0.048
91584026|NCT01249274|183058523|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.5||||0.06|TWO_SIDED|95.0|0.92|13.3|||Regression, Cox||Ratio presented is for placebo versus progesterone|||13.30|0.92|0.06
91584027|NCT01498653|183058524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|28.5|||<|0.001|TWO_SIDED|95.0|20.1|36.9|||ANCOVA|||||36.9|20.1|<0.001
91584028|NCT03421431|183058540|SUPERIORITY||Least Squares (LS) mean difference|12.46||||0.0495|TWO_SIDED|95.0|0.029|24.891|||ANCOVA|||||24.891|0.029|0.0495
91584029|NCT03421431|183058540|SUPERIORITY||LS mean difference|6.257||||0.3039|TWO_SIDED|95.0|-5.754|18.268|||ANCOVA|||||18.268|-5.754|0.3039
91584030|NCT03421431|183058540|SUPERIORITY||LS mean difference|6.203||||0.213|TWO_SIDED|95.0|-3.615|16.021|||ANCOVA|||||16.021|-3.615|0.2130
91584031|NCT03421431|183058541|SUPERIORITY||LS mean difference|4.717||||0.0009|TWO_SIDED|95.0|1.98|7.455|||ANCOVA|||||7.455|1.980|0.0009
91584032|NCT03421431|183058541|SUPERIORITY||LS mean difference|0.934||||0.4946|TWO_SIDED|95.0|-1.766|3.635|||ANCOVA|||||3.635|-1.766|0.4946
91584033|NCT03421431|183058541|SUPERIORITY||LS mean difference|3.783||||0.0005|TWO_SIDED|95.0|1.708|5.858|||ANCOVA|||||5.858|1.708|0.0005
91584034|NCT03421431|183058542|SUPERIORITY||LS mean difference|0.076||||0.2756|TWO_SIDED|95.0|-0.062|0.214|||ANCOVA|||||0.214|-0.062|0.2756
91584035|NCT03421431|183058542|SUPERIORITY||LS mean difference|-0.003||||0.9686|TWO_SIDED|95.0|-0.136|0.131|||ANCOVA|||||0.131|-0.136|0.9686
91584036|NCT03421431|183058542|SUPERIORITY||LS mean difference|0.079||||0.1406|TWO_SIDED|95.0|-0.026|0.184|||ANCOVA|||||0.184|-0.026|0.1406
91584037|NCT03421431|183058543|SUPERIORITY||LS mean difference|-0.125||||0.613|TWO_SIDED|95.0|-0.613|0.363|||ANCOVA|||||0.363|-0.613|0.6130
91584038|NCT03421431|183058543|SUPERIORITY||LS mean difference|-0.049||||0.8366|TWO_SIDED|95.0|-0.521|0.423|||ANCOVA|||||0.423|-0.521|0.8366
91584039|NCT03421431|183058543|SUPERIORITY||LS mean difference|-0.076||||0.7015|TWO_SIDED|95.0|-0.466|0.315|||ANCOVA|||||0.315|-0.466|0.7015
91584040|NCT03421431|183058544|SUPERIORITY||LS mean difference|-0.186||||0.3875|TWO_SIDED|95.0|-0.613|0.24|||ANCOVA|||||0.240|-0.613|0.3875
91584041|NCT03421431|183058544|SUPERIORITY||LS mean difference|-0.248||||0.2331|TWO_SIDED|95.0|-0.657|0.162|||ANCOVA|||||0.162|-0.657|0.2331
91646807|NCT01029769|183185253|OTHER|"a logistic regression model with remission as the dependent variable and switch of treatment (yes/no) and PANSS-total score at visit 3 as independent variables was used. Multiple imputation (based upon 20 imputations, primary analysis), last observation carried forward and completers only analyses were performed."|||||=|0.01||||||Multiple imputation was performed separately for the switch and non-switch arms and the imputation model included the PANSS total score from all visits from phase II baseline (visit 2) onwards, remission at visit 7 and phase I arm allocation|Regression, Logistic|||Irrespective of the initially assigned antipsychotic treatment in period 1 of the trial (2-week-phase), the patients showing little improvement over the two weeks of treatment in period 1 now switched from the initial treatment in period 2 of the trial (6-week-phase) were grouped together as well as the patients non-switched from their initial treatment.||||=0.01
91584042|NCT03421431|183058544|SUPERIORITY||LS mean difference|0.061||||0.7164|TWO_SIDED|95.0|-0.272|0.395|||ANCOVA|||||0.395|-0.272|0.7164
91777932|NCT03763877|183437558|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|3.71||0.8013|TWO_SIDED|95.0|-8.3|6.4|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.4|-8.3|0.8013
91584043|NCT03421431|183058545|SUPERIORITY||LS mean difference|0.21|||<|0.0001|TWO_SIDED|95.0|0.11|0.311|||ANCOVA|||||0.311|0.110|<0.0001
91584044|NCT03421431|183058545|SUPERIORITY||LS mean difference|0.046||||0.348|TWO_SIDED|95.0|-0.051|0.143|||ANCOVA|||||0.143|-0.051|0.3480
91584045|NCT03421431|183058545|SUPERIORITY||LS mean difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.085|0.243|||ANCOVA|||||0.243|0.085|<0.0001
91584046|NCT03421431|183058546|SUPERIORITY||LS mean difference|-0.299||||0.0897|TWO_SIDED|95.0|-0.645|0.047|||ANCOVA|||||0.047|-0.645|0.0897
91584047|NCT03421431|183058546|SUPERIORITY||LS mean difference|-0.251||||0.1411|TWO_SIDED|95.0|-0.586|0.085|||ANCOVA|||||0.085|-0.586|0.1411
91584048|NCT03421431|183058546|SUPERIORITY||LS mean difference|-0.048||||0.733|TWO_SIDED|95.0|-0.326|0.23|||ANCOVA|||||0.230|-0.326|0.7330
91584049|NCT03421431|183058547|SUPERIORITY||LS mean difference|51.873||||0.9143|TWO_SIDED|95.0|-901.574|1005.32|||ANCOVA|||||1005.320|-901.574|0.9143
91584050|NCT03421431|183058547|SUPERIORITY||LS mean difference|404.168||||0.3718|TWO_SIDED|95.0|-489.519|1297.854|||ANCOVA|||||1297.854|-489.519|0.3718
91584051|NCT03421431|183058547|SUPERIORITY||LS mean difference|-352.295||||0.3466|TWO_SIDED|95.0|-1091.308|386.719|||ANCOVA|||||386.719|-1091.308|0.3466
91584052|NCT03421431|183058548|SUPERIORITY||LS mean difference|0.173||||0.0003|TWO_SIDED|95.0|0.081|0.264|||ANCOVA|||||0.264|0.081|0.0003
91584053|NCT03421431|183058548|SUPERIORITY||LS mean difference|0.025||||0.5685|TWO_SIDED|95.0|-0.062|0.113|||ANCOVA|||||0.113|-0.062|0.5685
91584054|NCT03421431|183058548|SUPERIORITY||LS mean difference|0.147|||<|0.0001|TWO_SIDED|95.0|0.075|0.219|||ANCOVA|||||0.219|0.075|<0.0001
91584055|NCT03421431|183058549|SUPERIORITY||LS mean difference|-0.133||||0.0282|TWO_SIDED|95.0|-0.252|-0.015|||ANCOVA|||||-0.015|-0.252|0.0282
91584056|NCT03421431|183058549|SUPERIORITY||LS mean difference|-0.068||||0.2412|TWO_SIDED|95.0|-0.182|0.046|||ANCOVA|||||0.046|-0.182|0.2412
91584057|NCT03421431|183058549|SUPERIORITY||LS mean difference|-0.066||||0.1649|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|||||0.027|-0.158|0.1649
91584058|NCT03421431|183058550|SUPERIORITY||LS mean difference|0.009||||0.4357|TWO_SIDED|95.0|-0.014|0.032|||ANCOVA|||||0.032|-0.014|0.4357
91584059|NCT03421431|183058550|SUPERIORITY||LS mean difference|0.001||||0.8989|TWO_SIDED|95.0|-0.021|0.023|||ANCOVA|||||0.023|-0.021|0.8989
91584060|NCT03421431|183058550|SUPERIORITY||LS mean difference|0.008||||0.412|TWO_SIDED|95.0|-0.011|0.026|||ANCOVA|||||0.026|-0.011|0.4120
91584061|NCT03421431|183058551|SUPERIORITY||LS mean difference|-1.731||||0.0134|TWO_SIDED|95.0|-3.095|-0.368|||ANCOVA|||||-0.368|-3.095|0.0134
91584062|NCT03421431|183058551|SUPERIORITY||LS mean difference|-0.327||||0.6263|TWO_SIDED|95.0|-1.656|1.001|||ANCOVA|||||1.001|-1.656|0.6263
91584063|NCT03421431|183058551|SUPERIORITY||LS mean difference|-1.404||||0.0115|TWO_SIDED|95.0|-2.487|-0.322|||ANCOVA|||||-0.322|-2.487|0.0115
91584064|NCT03421431|183058552|SUPERIORITY||LS mean difference|-3.723||||0.4608|TWO_SIDED|95.0|-13.7|6.253|||ANCOVA|||||6.253|-13.700|0.4608
91584065|NCT03421431|183058552|SUPERIORITY||LS mean difference|-2.377||||0.6238|TWO_SIDED|95.0|-11.962|7.207|||ANCOVA|||||7.207|-11.962|0.6238
91584066|NCT03421431|183058552|SUPERIORITY||LS mean difference|-1.346||||0.7367|TWO_SIDED|95.0|-9.268|6.576|||ANCOVA|||||6.576|-9.268|0.7367
91584067|NCT03421431|183058553|SUPERIORITY||LS mean difference|-0.407||||0.8302|TWO_SIDED|95.0|-4.287|3.474|||ANCOVA|||||3.474|-4.287|0.8302
91584068|NCT03421431|183058553|SUPERIORITY||LS mean difference|-1.28||||0.5053|TWO_SIDED|95.0|-5.192|2.632|||ANCOVA|||||2.632|-5.192|0.5053
91584069|NCT03421431|183058553|SUPERIORITY||LS mean difference|0.873||||0.476|TWO_SIDED|95.0|-1.62|3.366|||ANCOVA|||||3.366|-1.620|0.4760
91584070|NCT03421431|183058554|SUPERIORITY||LS mean difference|-5.91||||0.0639|TWO_SIDED|95.0|-12.171|0.351|||ANCOVA|||||0.351|-12.171|0.0639
91584071|NCT03421431|183058554|SUPERIORITY||LS mean difference|-2.064||||0.4884|TWO_SIDED|95.0|-7.971|3.843|||ANCOVA|||||3.843|-7.971|0.4884
91584072|NCT03421431|183058554|SUPERIORITY||LS mean difference|-3.846||||0.1532|TWO_SIDED|95.0|-9.156|1.464|||ANCOVA|||||1.464|-9.156|0.1532
91777933|NCT03763877|183437558|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|3.81||0.8694|TWO_SIDED|95.0|-8.2|7.0|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|7.0|-8.2|0.8694
91777934|NCT03763877|183437558|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|3.8||0.0581|TWO_SIDED|95.0|-14.9|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|0.3|-14.9|0.0581
91777935|NCT03763877|183437559|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|2.44||0.6681|TWO_SIDED|95.0|-3.8|5.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-3.8|0.6681
91777936|NCT03763877|183437559|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.51||0.8224|TWO_SIDED|95.0|-4.4|5.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.5|-4.4|0.8224
91777937|NCT03763877|183437559|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|2.5||0.0924|TWO_SIDED|95.0|-9.2|0.7|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7|-9.2|0.0924
91777938|NCT03763877|183437560|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.256||0.5148|TWO_SIDED|95.0|-0.68|0.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.34|-0.68|0.5148
91777939|NCT03763877|183437560|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.261||0.0434|TWO_SIDED|95.0|-1.05|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.02|-1.05|0.0434
91777940|NCT03763877|183437560|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.261||0.0494|TWO_SIDED|95.0|-1.04|0.0|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.00|-1.04|0.0494
91777941|NCT03763877|183437561|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.111||0.2449|TWO_SIDED|95.0|-0.35|0.09|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.09|-0.35|0.2449
91777942|NCT03763877|183437561|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.115||0.0502|TWO_SIDED|95.0|-0.46|0.0|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.00|-0.46|0.0502
91777943|NCT03763877|183437561|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.113||0.0123|TWO_SIDED|95.0|-0.51|-0.06|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.06|-0.51|0.0123
91777944|NCT03763877|183437562|SUPERIORITY||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.2172||0.251|TWO_SIDED|95.0|-0.682|0.18|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.180|-0.682|0.2510
91777945|NCT03763877|183437562|SUPERIORITY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.2202||0.8246|TWO_SIDED|95.0|-0.486|0.388|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.388|-0.486|0.8246
91584073|NCT03421431|183058555|SUPERIORITY||LS mean difference|-0.46||||0.0811|TWO_SIDED|95.0|-0.978|0.058|||ANCOVA|||||0.058|-0.978|0.0811
91584074|NCT03421431|183058555|SUPERIORITY||LS mean difference|0.117||||0.6312|TWO_SIDED|95.0|-0.367|0.601|||ANCOVA|||||0.601|-0.367|0.6312
91584075|NCT03421431|183058555|SUPERIORITY||LS mean difference|-0.577||||0.0099|TWO_SIDED|95.0|-1.011|-0.143|||ANCOVA|||||-0.143|-1.011|0.0099
91777946|NCT03763877|183437562|SUPERIORITY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.2216||0.9067|TWO_SIDED|95.0|-0.466|0.414|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.414|-0.466|0.9067
91777947|NCT03763877|183437563|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.0468||0.6951|TWO_SIDED|95.0|-0.111|0.075|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.075|-0.111|0.6951
91777948|NCT03763877|183437563|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.0472||0.103|TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.016|-0.171|0.1030
91777949|NCT03763877|183437563|SUPERIORITY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.0471||0.8583|TWO_SIDED|95.0|-0.085|0.102|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.102|-0.085|0.8583
91777950|NCT03763877|183437564|SUPERIORITY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.1777||0.5576|TWO_SIDED|95.0|-0.457|0.248|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.248|-0.457|0.5576
91777951|NCT03763877|183437564|SUPERIORITY||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.1799||0.4261|TWO_SIDED|95.0|-0.213|0.501|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.501|-0.213|0.4261
91777952|NCT03763877|183437564|SUPERIORITY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.1822||0.6571|TWO_SIDED|95.0|-0.281|0.443|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.443|-0.281|0.6571
91777953|NCT03763877|183437565|SUPERIORITY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.2851||0.5732|TWO_SIDED|95.0|-0.727|0.405|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.405|-0.727|0.5732
91777954|NCT03763877|183437565|SUPERIORITY||Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.2884||0.6312|TWO_SIDED|95.0|-0.712|0.434|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.434|-0.712|0.6312
91777955|NCT03763877|183437565|SUPERIORITY||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.2865||0.4857|TWO_SIDED|95.0|-0.769|0.368|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.368|-0.769|0.4857
91708403|NCT03299101|183309716|SUPERIORITY||Mean Difference (Net)|21.07|STANDARD_ERROR_OF_MEAN|22.12||0.341|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.||||0.341
91521109|NCT02231177|182916983|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|STANDARD_DEVIATION|72.08|||TWO_SIDED|90.0|0.79|1.24|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg; Tiotropium 5 µg). No formal testing.||1.24|0.79|
91521110|NCT02954354|182917015|SUPERIORITY||Difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.8|-17.8||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||The primary analysis of time to alleviation of symptoms was a comparison of baloxavir with placebo in all participants in the intention-to-treat infection population. Statistical tests were performed at the 0.05 significance level.||-17.8|-35.8|<0.0001
91521111|NCT02954354|182917015|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||<0.0001
91521112|NCT02954354|182917016|SUPERIORITY||Difference|-0.3||||0.756|TWO_SIDED|95.0|-6.6|6.6||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||A secondary analysis of time to alleviation of symptoms, consisting of a comparison between the 20 to 64 years of age stratum of the baloxavir group and the oseltamivir group, was conducted if statistical significance was observed in the primary analysis in order to maintain the overall Type I error.||6.6|-6.6|0.7560
91521113|NCT02954354|182917016|SUPERIORITY|||||||0.3761||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.3761
91521114|NCT02954354|182917017|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
91521115|NCT02954354|182917017|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
91521116|NCT02954354|182917017|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
91521117|NCT02954354|182917017|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
91521118|NCT02954354|182917017|SUPERIORITY|||||||0.4767||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.4767
91521119|NCT02954354|182917017|SUPERIORITY|||||||0.3353||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3353
91521120|NCT02954354|182917018|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
91521121|NCT02954354|182917018|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
91521122|NCT02954354|182917018|SUPERIORITY|||||||0.0852||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0852
91521123|NCT02954354|182917018|SUPERIORITY|||||||0.0063||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0063
91521124|NCT02954354|182917018|SUPERIORITY|||||||0.6187||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.6187
91521125|NCT02954354|182917018|SUPERIORITY|||||||0.8637||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|||Day 9||||0.8637
91521126|NCT02954354|182917019|SUPERIORITY|||||||0.6145||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.6145
91584076|NCT03421431|183058568|SUPERIORITY||LS mean difference|1.356||||0.112|TWO_SIDED|95.0|-0.322|3.034|||ANCOVA|||||3.034|-0.322|0.1120
91584077|NCT03421431|183058568|SUPERIORITY||LS mean difference|0.647||||0.4229|TWO_SIDED|95.0|-0.947|2.24|||ANCOVA|||||2.240|-0.947|0.4229
91584078|NCT03421431|183058568|SUPERIORITY||LS mean difference|0.71||||0.2764|TWO_SIDED|95.0|-0.577|1.996|||ANCOVA|||||1.996|-0.577|0.2764
91584079|NCT03421431|183058569|SUPERIORITY||LS mean difference|0.008||||0.5606|TWO_SIDED|95.0|-0.02|0.037|||ANCOVA|||||0.037|-0.020|0.5606
91584080|NCT03421431|183058569|SUPERIORITY||LS mean difference|0.023||||0.1002|TWO_SIDED|95.0|-0.004|0.05|||ANCOVA|||||0.050|-0.004|0.1002
91584081|NCT03421431|183058569|SUPERIORITY||LS mean difference|-0.014||||0.2002|TWO_SIDED|95.0|-0.036|0.008|||ANCOVA|||||0.008|-0.036|0.2002
91584082|NCT03421431|183058570|SUPERIORITY||LS mean difference|-178.787||||0.7014|TWO_SIDED|95.0|-1098.454|740.88|||ANCOVA|||||740.880|-1098.454|0.7014
91584083|NCT03421431|183058570|SUPERIORITY||LS mean difference|52.307||||0.907|TWO_SIDED|95.0|-830.934|935.547|||ANCOVA|||||935.547|-830.934|0.9070
91584084|NCT03421431|183058570|SUPERIORITY||LS mean difference|-231.094||||0.536|TWO_SIDED|95.0|-967.273|505.086|||ANCOVA|||||505.086|-967.273|0.5360
91777956|NCT03763877|183437566|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.074||0.5737|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.19|-0.11|0.5737
91584085|NCT03421431|183058571|SUPERIORITY||LS mean difference|-753.153||||0.2985|TWO_SIDED|95.0|-2183.92|677.614|||ANCOVA|||||677.614|-2183.920|0.2985
91584086|NCT03421431|183058571|SUPERIORITY||LS mean difference|139.107||||0.8413|TWO_SIDED|95.0|-1236.689|1514.902|||ANCOVA|||||1514.902|-1236.689|0.8413
91584087|NCT03421431|183058571|SUPERIORITY||LS mean difference|-892.26||||0.1168|TWO_SIDED|95.0|-2011.705|227.186|||ANCOVA|||||227.186|-2011.705|0.1168
91584088|NCT03421431|183058572|SUPERIORITY||LS mean difference|33.491|||<|0.0001|TWO_SIDED|95.0|17.984|48.998|||ANCOVA|||||48.998|17.984|<0.0001
91584089|NCT03421431|183058572|SUPERIORITY||LS mean difference|30.814|||<|0.0001|TWO_SIDED|95.0|15.802|45.825|||ANCOVA|||||45.825|15.802|<0.0001
91584090|NCT03421431|183058572|SUPERIORITY||LS mean difference|2.677||||0.6757|TWO_SIDED|95.0|-9.946|15.3|||ANCOVA|||||15.300|-9.946|0.6757
91584091|NCT03421431|183058573|SUPERIORITY||LS mean difference|21.3||||0.0134|TWO_SIDED|95.0|4.533|38.067|||ANCOVA|||||38.067|4.533|0.0134
91584092|NCT03421431|183058573|SUPERIORITY||LS mean difference|5.847||||0.4686|TWO_SIDED|95.0|-10.116|21.811|||ANCOVA|||||21.811|-10.116|0.4686
91584093|NCT03421431|183058573|SUPERIORITY||LS mean difference|15.453||||0.0181|TWO_SIDED|95.0|2.699|28.206|||ANCOVA|||||28.206|2.699|0.0181
91584094|NCT03421431|183058574|SUPERIORITY||LS mean difference|4.324||||0.0557|TWO_SIDED|95.0|-0.108|8.756|||ANCOVA|||||8.756|-0.108|0.0557
91584095|NCT03421431|183058574|SUPERIORITY||LS mean difference|2.305||||0.2867|TWO_SIDED|95.0|-1.955|6.566|||ANCOVA|||||6.566|-1.955|0.2867
91584096|NCT03421431|183058574|SUPERIORITY||LS mean difference|2.019||||0.2437|TWO_SIDED|95.0|-1.39|5.429|||ANCOVA|||||5.429|-1.390|0.2437
91584097|NCT03421431|183058575|SUPERIORITY||LS mean difference|0.019||||0.9913|TWO_SIDED|95.0|-3.491|3.53|||ANCOVA|||||3.530|-3.491|0.9913
91584098|NCT03421431|183058575|SUPERIORITY||LS mean difference|0.995||||0.553|TWO_SIDED|95.0|-2.323|4.314|||ANCOVA|||||4.314|-2.323|0.5530
91584099|NCT03421431|183058575|SUPERIORITY||LS mean difference|-0.976||||0.4729|TWO_SIDED|95.0|-3.665|1.713|||ANCOVA|||||1.713|-3.665|0.4729
91777957|NCT03763877|183437566|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.074||0.7563|TWO_SIDED|95.0|-0.12|0.17|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.17|-0.12|0.7563
91777958|NCT03763877|183437566|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.075||0.5695|TWO_SIDED|95.0|-0.19|0.11|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.11|-0.19|0.5695
91777959|NCT03763877|183437567|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.659||0.9552|TWO_SIDED|95.0|-1.34|1.27|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.27|-1.34|0.9552
91777960|NCT03763877|183437567|SUPERIORITY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.674||0.2633|TWO_SIDED|95.0|-2.1|0.58|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.58|-2.10|0.2633
91777961|NCT03763877|183437567|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.673||0.1962|TWO_SIDED|95.0|-2.21|0.46|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.46|-2.21|0.1962
91777962|NCT03763877|183437568|SUPERIORITY||Odds Ratio (OR)|1.353||||0.8245|TWO_SIDED|95.0|0.094|19.554|||Regression, Logistic|||||19.554|0.094|0.8245
91777963|NCT03763877|183437568|SUPERIORITY||Odds Ratio (OR)|2.791||||0.414|TWO_SIDED|95.0|0.238|32.752|||Regression, Logistic|||||32.752|0.238|0.4140
91777964|NCT03763877|183437568|SUPERIORITY||Odds Ratio (OR)|14.872||||0.0341|TWO_SIDED|95.0|1.226|180.452|||Regression, Logistic|||||180.452|1.226|0.0341
91777965|NCT03763877|183437569|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.84||0.4626|TWO_SIDED|95.0|-16.1|7.5|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.5|-16.1|0.4626
91777966|NCT03763877|183437569|SUPERIORITY||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|5.88||0.316|TWO_SIDED|95.0|-17.9|5.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-17.9|0.3160
91584100|NCT04147650|183058585|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1352|TWO_SIDED|95.0|0.62|7.62|||Regression, Logistic|||0.05 % VOS versus vehicle||7.62|0.62|0.1352
91584101|NCT04147650|183058585|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2823|TWO_SIDED|95.0|0.49|6.45|||Regression, Logistic|||0.10% VOS versus vehicle||6.45|0.49|0.2823
91584102|NCT04147650|183058585|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0889|TWO_SIDED|95.0|0.7|8.3|||Regression, Logistic|||0.20% VOS versus vehicle||8.30|0.70|0.0889
91584103|NCT04147650|183058586|SUPERIORITY||Least square mean difference|-2.6||||0.3604|TWO_SIDED|95.0|-9.6|4.3|||ANCOVA|||0.05% VOS versus vehicle||4.3|-9.6|0.3604
91584104|NCT04147650|183058586|SUPERIORITY||Least square mean difference|-2.6||||0.3737|TWO_SIDED|95.0|-9.6|4.4|||ANCOVA|||0.10% VOS versus vehicle||4.4|-9.6|0.3737
91584105|NCT04147650|183058586|SUPERIORITY||Least square mean difference|1.8||||0.5307|TWO_SIDED|95.0|-5.1|8.6|||ANCOVA|||0.20% VOS versus vehicle||8.6|-5.1|0.5307
91584106|NCT01178671|183058600|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
91584107|NCT01178671|183058601|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
91584108|NCT01178671|183058602|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||.14
91584109|NCT01178671|183058603|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.50
91584110|NCT01178671|183058604|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||0.023
91584111|NCT01178671|183058605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
91584112|NCT01178671|183058606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.042|TWO_SIDED|95.0|1.1|19.9|||Mixed Models Analysis|||||19.9|1.1|0.042
91584113|NCT01178671|183058607|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
91584114|NCT01178671|183058608|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
91584115|NCT01178671|183058609|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
91584116|NCT01078675|183058613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.88|STANDARD_DEVIATION|18.222|<|0.001|TWO_SIDED|-42.88|-45.44|-40.32||P-value\<0.001 at Month 24. No adjustment for multiple comparisons is made for individual age group.|ANCOVA|P-value is two-sided and based on ANCOVA using age group as the fixed factor, and study centre and the baseline value as covariates.||||-40.32|-45.44|<0.001
91584117|NCT02513303|183058626|SUPERIORITY|||||||0.2942|||||||Regression, Logistic|||||||0.2942
91584118|NCT00679627|183058627|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91584119|NCT00679627|183058628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.011|TWO_SIDED|95.0|0.37|0.89|||Regression, Cox|||||0.89|0.37|0.011
91584120|NCT00679627|183058629|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91584121|NCT00679627|183058630|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||||||0.002
91584122|NCT00679627|183058633|SUPERIORITY_OR_OTHER|||||||0.269||||||Baseline|Cochran-Mantel-Haenszel|||||||0.269
91584123|NCT00679627|183058633|SUPERIORITY_OR_OTHER|||||||0.835||||||Month 24|Cochran-Mantel-Haenszel|||||||0.835
91584124|NCT00679627|183058634|SUPERIORITY_OR_OTHER|||||||0.194||||||Orientation subscale|ANCOVA|||||||0.194
91584125|NCT00679627|183058634|SUPERIORITY_OR_OTHER|||||||0.353||||||Registration subscale|ANCOVA|||||||0.353
91584126|NCT00679627|183058634|SUPERIORITY_OR_OTHER|||||||0.009||||||Attention and Calculation subscale|ANCOVA|||||||0.009
91584127|NCT00679627|183058634|SUPERIORITY_OR_OTHER|||||||0.158||||||Recall subscale|ANCOVA|||||||0.158
91584128|NCT00679627|183058634|SUPERIORITY_OR_OTHER|||||||0.088||||||Language subscale|ANCOVA|||||||0.088
91584129|NCT00679627|183058635|SUPERIORITY_OR_OTHER|||||||0.01||||||Initiation subscale|ANCOVA|||||||0.010
91584130|NCT00679627|183058635|SUPERIORITY_OR_OTHER|||||||0.043||||||Planning and Organization subscale|ANCOVA|||||||0.043
91584131|NCT00679627|183058635|SUPERIORITY_OR_OTHER|||||||0.018||||||Effective Performance subscale|ANCOVA|||||||0.018
91584132|NCT00679627|183058635|SUPERIORITY_OR_OTHER|||||||0.005||||||Basic subscale|ANCOVA|||||||0.005
91584133|NCT00679627|183058635|SUPERIORITY_OR_OTHER|||||||0.054||||||Instrumental subscale|ANCOVA|||||||0.054
91584134|NCT00679627|183058635|SUPERIORITY_OR_OTHER|||||||0.137||||||Leisure subscale|ANCOVA|||||||0.137
91584135|NCT03513588|183058645|OTHER||Least Squares Mean Difference|-24.34|||<|0.001|TWO_SIDED|80.0|-31.28|-16.7|||ANCOVA|||||-16.70|-31.28|<0.001
91584136|NCT03513588|183058645|OTHER||Least Squares Mean Difference|-33.91|||<|0.001|TWO_SIDED|80.0|-39.78|-27.47|||ANCOVA|||||-27.47|-39.78|<0.001
91584137|NCT01275131|183058656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.95||||0.0009|TWO_SIDED|90.0|7.37|20.54|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 2/6||20.54|7.37|0.0009
91584138|NCT01275131|183058656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|18.14|||<|0.0001|TWO_SIDED|90.0|11.55|24.72|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 4/8||24.72|11.55|<0.0001
91584139|NCT01275131|183058658|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.41|||<|0.0001|TWO_SIDED|90.0|11.86|20.97|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 2/7||20.97|11.86|<0.0001
91584140|NCT01275131|183058658|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|14.1|||<|0.0001|TWO_SIDED|90.0|9.55|18.65|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 3/8||18.65|9.55|<0.0001
91584141|NCT01275131|183058658|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.32||||0.0552|TWO_SIDED|90.0|0.77|9.88|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 5/10||9.88|0.77|0.0552
91584142|NCT00903682|183058692|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The hypothesis is that the proportion of patients with at least 1 treatment-emergent Grade 1-4 neuropsychiatric adverse event, observed between Baseline through Week 12 and judged to be at least possibly drug-related, is significantly lower in the ETR arm than in the EFV arm. Assuming a significance level of 5%, a sample size of 75 subjects per arm would provide over 90% power to detect a 29% difference in treatment-emergent, drug-related Grade 1-4 neuropsychiatric adverse events.||||<0.001
91584143|NCT00903682|183058693|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.61|||||TWO_SIDED|95.0|-12.0|15.23|||||Difference in proportion of response ETR minus EFV|||15.23|-12.00|
91584144|NCT03110185|183058701|OTHER|Correlation||||||0.0761||||||Delirium Incidence. There were no multiple comparisons, but includes age as a regressor. a priori threshold was p \< 0.05.|Regression, Logistic|Generalized logistic regression for delirium incidence and total DMN fc with age as a regressor.||||||0.0761
91584145|NCT03430206|183058752|OTHER|||||||0.206|||||||Regression, Negative Binomial|||||||0.206
91584146|NCT03430206|183058753|OTHER|||||||0.101|||||||Regression, Negative Binomial|||||||0.101
91584147|NCT03430206|183058754|OTHER|||||||0.371|||||||Regression, Negative Binomial|||||||0.371
91584148|NCT03430206|183058756|OTHER|||||||0.601|||||||Regression, Negative Binomial|||||||0.601
91584149|NCT03430206|183058757|OTHER|||||||0.738|||||||Regression, Negative Binomial|||||||0.738
91646808|NCT03111407|183185258|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.2342|||||||t-test, 2 sided|||"Hip Knee Angle value 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 179.9 +/-2.9 (44) (171, 185.3)~Conventional group: 178.9 +/-3.9 (26) (167, 185)"||||0.2342
91584150|NCT04118374|183058773|SUPERIORITY||Median Difference (Final Values)|0.2|||<|0.01|TWO_SIDED|95.0|-0.5|1.8|||ANOVA|||||1.8|-0.5|<0.01
91584151|NCT00557947|183058774|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|difference proportions of successes (%)|4.8||||0.2188|TWO_SIDED|95.0|0.0|10.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||10.9|-0.0|0.2188
91584152|NCT00557947|183058775|SUPERIORITY_OR_OTHER||||||<|0.0001||0.0|||||t-test, 2 sided|||||||<0.0001
91584153|NCT00557947|183058776|SUPERIORITY_OR_OTHER|||||||0.3877||0.0|||||McNemar|||||||0.3877
91584154|NCT00557947|183058777|SUPERIORITY_OR_OTHER|||||||0.7539||0.0|||||McNemar|||||||0.7539
91584155|NCT00557947|183058778|SUPERIORITY_OR_OTHER|||||||1||0.0|||||McNemar|||||||1.0000
91584156|NCT04737187|183058780|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.77||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).||0.77|0.49|< 0.001
91777967|NCT03763877|183437569|SUPERIORITY||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|6.19||0.0204|TWO_SIDED|95.0|-27.4|-2.4|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-2.4|-27.4|0.0204
91777968|NCT03763877|183437570|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.91||0.4601|TWO_SIDED|95.0|-10.8|5.0|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.0|-10.8|0.4601
91777969|NCT03763877|183437570|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.95||0.9782|TWO_SIDED|95.0|-8.1|7.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.9|-8.1|0.9782
91777970|NCT03763877|183437570|SUPERIORITY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.13||0.0205|TWO_SIDED|95.0|-18.3|-1.6|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.6|-18.3|0.0205
91777971|NCT03763877|183437571|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.538||0.9529|TWO_SIDED|95.0|-1.12|1.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.05|-1.12|0.9529
91777972|NCT03763877|183437571|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.532||0.1285|TWO_SIDED|95.0|-1.9|0.25|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.25|-1.90|0.1285
91777973|NCT03763877|183437571|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.565||0.0417|TWO_SIDED|95.0|-2.32|-0.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.05|-2.32|0.0417
91777974|NCT03763877|183437572|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3141|TWO_SIDED|95.0|-0.69|0.23|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.23|-0.69|0.3141
91777975|NCT03763877|183437572|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0656|TWO_SIDED|95.0|-0.88|0.03|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.03|-0.88|0.0656
91777976|NCT03763877|183437572|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.237||0.0101|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.16|-1.12|0.0101
91777977|NCT02930824|183437593|SUPERIORITY|We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||||0.78||||||Analysis was done of adult patients enrolled that have a CYP2C19 Rapid or Ultra-rapid metabolizer result.|t-test, 2 sided|||We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||0.78
91777978|NCT02930824|183437594|SUPERIORITY|||||||0.031||||||Adjusted for baseline score, race, baseline proton pump inhibitor use, baseline histamine receptor antagonist use. A sensitivity analysis of participants only on omeprazole revealed similar findings.|Wilcoxon (Mann-Whitney)|Adjusted these end points for covariates, including the baseline score, race, and baseline medications using logistic regression||||||0.031
91777979|NCT02930824|183437595|SUPERIORITY||Hazard Ratio (HR)|2.42||||0.07|TWO_SIDED|95.0|0.9|6.3||unadjusted|Log Rank|||||6.3|0.9|0.07
91777980|NCT02930824|183437596|SUPERIORITY|||||||0.97||||||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.|Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.97
91777981|NCT02930824|183437597|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.83
91777982|NCT01524796|183437605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||paired Wilcoxon signed-rank test|||||||<0.001
91777983|NCT01524796|183437606|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
91777984|NCT01524796|183437607|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
91777985|NCT02121158|183437639|EQUIVALENCE|Unadjusted|Hazard Ratio (HR)|0.915||||0.7457|TWO_SIDED|95.0|0.534|1.568|||Cox Proportional Hazards|||||1.568|0.534|0.7457
91777986|NCT02435992|183437640|SUPERIORITY||Odds Ratio (OR)|3.586||||0.0001|TWO_SIDED|95.0|1.938|6.636|||Cochran-Mantel-Haenszel|||||6.636|1.938|0.0001
91777987|NCT02435992|183437641|SUPERIORITY||Odds Ratio (OR)|2.755||||0.0001|TWO_SIDED|95.0|1.767|4.294|||Cochran-Mantel-Haenszel|||||4.294|1.767|0.0001
91777988|NCT03773978|183437675|SUPERIORITY||Hazard Ratio (HR)|0.241|||<|0.001|TWO_SIDED|95.0|0.128|0.453|||Log Rank|||||0.453|0.128|<0.001
91777989|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|2.72||||0.052|TWO_SIDED|95.0|0.99|7.46|||Regression, Logistic|||at week 16||7.46|0.99|0.052
91777990|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.28|||Regression, Logistic|||at week 20||8.28|1.60|0.002
91777991|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|4.34|||<|0.001|TWO_SIDED|95.0|2.0|9.41|||Regression, Logistic|||at week 24||9.41|2.00|<0.001
91777992|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|3.37||||0.001|TWO_SIDED|95.0|1.62|7.01|||Regression, Logistic|||at week 28||7.01|1.62|0.001
91777993|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|3.0||||0.002|TWO_SIDED|95.0|1.48|6.07|||Regression, Logistic|||at week 32||6.07|1.48|0.002
91777994|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|3.25|||<|0.001|TWO_SIDED|95.0|1.62|6.52|||Regression, Logistic|||at week 36||6.52|1.62|<0.001
91777995|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|1.85|7.41|||Regression, Logistic|||at week 40||7.41|1.85|<0.001
91777996|NCT03773978|183437676|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.65|6.5|||Regression, Logistic|||at week 44||6.50|1.65|<0.001
91777997|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|1.25||||0.568|TWO_SIDED|95.0|0.59|2.65|||Regression, Logistic|||at week 16||2.65|0.59|0.568
91777998|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|2.92||||0.004|TWO_SIDED|95.0|1.4|6.09|||Regression, Logistic|||at week 20||6.09|1.40|0.004
91777999|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|2.1|9.15|||Regression, Logistic|||at week 24||9.15|2.10|<0.001
91778000|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|3.09||||0.002|TWO_SIDED|95.0|1.51|6.32|||Regression, Logistic|||at week 28||6.32|1.51|0.002
91778001|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|2.99||||0.003|TWO_SIDED|95.0|1.47|6.11|||Regression, Logistic|||at week 32||6.11|1.47|0.003
91778002|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|2.84||||0.003|TWO_SIDED|95.0|1.44|5.6|||Regression, Logistic|||at week 36||5.60|1.44|0.003
91778003|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.74|6.97|||Regression, Logistic|||at week 40||6.97|1.74|<0.001
91778004|NCT03773978|183437677|SUPERIORITY||Odds Ratio (OR)|2.87||||0.002|TWO_SIDED|95.0|1.46|5.66|||Regression, Logistic|||at week 44||5.66|1.46|0.002
91778005|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Regression, Logistic|||at week 16||1.87|0.52|0.972
91778006|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|2.47||||0.008|TWO_SIDED|95.0|1.27|4.81|||Regression, Logistic|||at week 20||4.81|1.27|0.008
91778007|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|2.57||||0.005|TWO_SIDED|95.0|1.33|4.97|||Regression, Logistic|||at week 24||4.97|1.33|0.005
91778008|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.001|TWO_SIDED|95.0|1.57|5.94|||Regression, Logistic|||at week 28||5.94|1.57|<0.001
91778009|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|2.42||||0.009|TWO_SIDED|95.0|1.25|4.71|||Regression, Logistic|||at week 32||4.71|1.25|0.009
91778010|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|2.8||||0.003|TWO_SIDED|95.0|1.43|5.47|||Regression, Logistic|||at week 36||5.47|1.43|0.003
91778011|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|2.93||||0.002|TWO_SIDED|95.0|1.47|5.83|||Regression, Logistic|||at week 40||5.83|1.47|0.002
91778012|NCT03773978|183437678|SUPERIORITY||Odds Ratio (OR)|1.93||||0.052|TWO_SIDED|95.0|0.99|3.74|||Regression, Logistic|||at week 44||3.74|0.99|0.052
91778013|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|1.35||||0.409|TWO_SIDED|95.0|0.66|2.75|||Regression, Logistic|||at week 16||2.75|0.66|0.409
91778014|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|2.13||||0.03|TWO_SIDED|95.0|1.07|4.23|||Regression, Logistic|||at week 20||4.23|1.07|0.030
91778015|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|2.36||||0.022|TWO_SIDED|95.0|1.13|4.92|||Regression, Logistic|||at week 24||4.92|1.13|0.022
91778016|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|2.05||||0.04|TWO_SIDED|95.0|1.03|4.08|||Regression, Logistic|||at week 28||4.08|1.03|0.040
91778017|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|2.13||||0.032|TWO_SIDED|95.0|1.07|4.24|||Regression, Logistic|||at week 32||4.24|1.07|0.032
91778018|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|1.71||||0.132|TWO_SIDED|95.0|0.85|3.42|||Regression, Logistic|||at week 36||3.42|0.85|0.132
91778019|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|2.02||||0.05|TWO_SIDED|95.0|1.0|4.1|||Regression, Logistic|||at week 40||4.10|1.00|0.050
91778020|NCT03773978|183437679|SUPERIORITY||Odds Ratio (OR)|2.32||||0.019|TWO_SIDED|95.0|1.15|4.71|||Regression, Logistic|||at week 44||4.71|1.15|0.019
91778021|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.92|||Regression, Logistic|||at week 16||1.92|0.33|0.620
91778022|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|1.3||||0.492|TWO_SIDED|95.0|0.61|2.78|||Regression, Logistic|||at week 20||2.78|0.61|0.492
91778023|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|1.17||||0.715|TWO_SIDED|95.0|0.5|2.75|||Regression, Logistic|||at week 24||2.75|0.50|0.715
91778024|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|1.4||||0.384|TWO_SIDED|95.0|0.66|2.99|||Regression, Logistic|||at week 28||2.99|0.66|0.384
91778025|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|1.47||||0.311|TWO_SIDED|95.0|0.7|3.1|||Regression, Logistic|||at week 32||3.10|0.70|0.311
91778026|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|1.58||||0.231|TWO_SIDED|95.0|0.75|3.34|||Regression, Logistic|||at week 36||3.34|0.75|0.231
91778027|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|1.82||||0.129|TWO_SIDED|95.0|0.84|3.95|||Regression, Logistic|||at week 40||3.95|0.84|0.129
91778028|NCT03773978|183437680|SUPERIORITY||Odds Ratio (OR)|2.23||||0.043|TWO_SIDED|95.0|1.02|4.84|||Regression, Logistic|||at week 44||4.84|1.02|0.043
91778029|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|1.1||||0.853|TWO_SIDED|95.0|0.4|2.98|||Regression, Logistic|||at week 16||2.98|0.40|0.853
91778030|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|0.7||||0.432|TWO_SIDED|95.0|0.29|1.71|||Regression, Logistic|||at week 20||1.71|0.29|0.432
91778031|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.41|2.31|||Regression, Logistic|||at week 24||2.31|0.41|0.960
91778032|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|1.71||||0.215|TWO_SIDED|95.0|0.73|4.01|||Regression, Logistic|||at week 28||4.01|0.73|0.215
91778033|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|1.8||||0.173|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||at week 32||4.22|0.77|0.173
91778034|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|1.46||||0.367|TWO_SIDED|95.0|0.64|3.33|||Regression, Logistic|||at week 36||3.33|0.64|0.367
91778035|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|1.9||||0.162|TWO_SIDED|95.0|0.77|4.67|||Regression, Logistic|||at week 40||4.67|0.77|0.162
91778036|NCT03773978|183437681|SUPERIORITY||Odds Ratio (OR)|1.96||||0.113|TWO_SIDED|95.0|0.85|4.5|||Regression, Logistic|||at week 44||4.50|0.85|0.113
91778037|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|0.8||||0.511|TWO_SIDED|95.0|0.42|1.55|||Regression, Logistic|||at week 16||1.55|0.42|0.511
91778038|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.64||||0.145|TWO_SIDED|95.0|0.84|3.2|||Regression, Logistic|||at week 20||3.20|0.84|0.145
91584157|NCT04737187|183058784|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.36|0.54||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|PFS Median analysis: A hierarchical testing method was used to control type I error and handle key secondary endpoint analysis. When the primary outcome measure significant testing was then performed sequentially on the key secondary outcome measure. statistically significant at 0.05 level.||0.54|0.36|< 0.001
91584158|NCT05227703|183058793|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.3||0.2925|TWO_SIDED|95.0|-7.0|2.1||Emraclidine 15 mg versus Placebo|Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|||2.1|-7.0|0.2925
91584159|NCT05227703|183058793|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.27||0.3914|TWO_SIDED|95.0|-2.5|6.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||6.4|-2.5|0.3914
91584160|NCT05227703|183058794|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.1165|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Emraclidine 15 mg versus Placebo||0.05|-0.48|0.1165
91584161|NCT05227703|183058794|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.134||0.8265|TWO_SIDED|95.0|-0.23|0.29|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||0.29|-0.23|0.8265
91584162|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.14||0.1167|TWO_SIDED|95.0|-4.0|0.5|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 1-- Emraclidine 15 mg versus Placebo||0.5|-4.0|0.1167
91584163|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.14||0.9254|TWO_SIDED|95.0|-2.1|2.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||2.3|-2.1|0.9254
91584164|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.55||0.8792|TWO_SIDED|95.0|-3.3|2.8|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 2-- Emraclidine 15 mg versus Placebo||2.8|-3.3|0.8792
91584165|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.52||0.5094|TWO_SIDED|95.0|-2.0|4.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||4.0|-2.0|0.5094
91613905|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.0002|TWO_SIDED|95.0|1.421|3.074|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.074|1.421|0.0002
91613906|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.288||||0.0006|TWO_SIDED|95.0|0.141|0.588|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.588|0.141|0.0006
91778039|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.38||||0.349|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||at week 24||2.72|0.70|0.349
91778040|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.63||||0.167|TWO_SIDED|95.0|0.82|3.25|||Regression, Logistic|||at week 28||3.25|0.82|0.167
91778041|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.55||||0.212|TWO_SIDED|95.0|0.78|3.07|||Regression, Logistic|||at week 32||3.07|0.78|0.212
91778042|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.21||||0.577|TWO_SIDED|95.0|0.62|2.39|||Regression, Logistic|||at week 36||2.39|0.62|0.577
91778043|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.51||||0.225|TWO_SIDED|95.0|0.78|2.95|||Regression, Logistic|||at week 40||2.95|0.78|0.225
91584166|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.76||0.4487|TWO_SIDED|95.0|-4.8|2.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 3-- Emraclidine 15 mg versus Placebo||2.1|-4.8|0.4487
91584167|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.72||0.4852|TWO_SIDED|95.0|-2.2|4.6|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||4.6|-2.2|0.4852
91584168|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.86||0.7593|TWO_SIDED|95.0|-4.2|3.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 4-- Emraclidine 15 mg versus Placebo||3.1|-4.2|0.7593
91646809|NCT03111407|183185259|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4427|||||||t-test, 2 sided|||"Knee Society Score Assessment 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 74.7 +/- 12.5 \[44\] (30.2, 78.0, 89.5), 95% C.I. (70.9, 78.5)~Conventional group: 72.4 +/- 11.6 \[26\] (45.0, 75.2, 90.1), 95% C.I. (67.7, 77.1)"||||0.4427
91778044|NCT03773978|183437682|SUPERIORITY||Odds Ratio (OR)|1.96||||0.055|TWO_SIDED|95.0|0.98|3.9|||Regression, Logistic|||at week 44||3.90|0.98|0.055
91778045|NCT03773978|183437684|SUPERIORITY||LS Mean difference|-4.33|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|-6.95|-1.7|||ANCOVA|||||-1.70|-6.95|0.001
91778046|NCT03773978|183437685|SUPERIORITY||LS Mean difference|-12.97|STANDARD_ERROR_OF_MEAN|4.262||0.003|TWO_SIDED|95.0|-21.39|-4.55|||ANCOVA|||||-4.55|-21.39|0.003
91778047|NCT03773978|183437686|SUPERIORITY||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.526||0.574|TWO_SIDED|95.0|-2.62|1.91|||ANCOVA|||||1.91|-2.62|0.574
91778048|NCT03773978|183437687|SUPERIORITY||LS Mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.348||0.208|TWO_SIDED|95.0|-0.26|1.15|||ANCOVA|||||1.15|-0.26|0.208
91778049|NCT03773978|183437688|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.438||0.019|TWO_SIDED|95.0|-1.98|-0.19|||ANCOVA|||||-0.19|-1.98|0.019
91778050|NCT00198822|183437725|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.05|ONE_SIDED|95.0||0.99||We set an a priori level of statistical significance of p equal to 0.05.|generalized estimating equations|RR with 95% CIs were estimated by GEE binomial regression, with a log link function and exchangeable correlation appropriate for binary data.|The vitamin A group and the Beta-carotene group were compared to the placebo group.|Sample size was based on an expected placebo group MR of 600/100,000 pregnancies, requiring 18,000 pregnancies to detect a 35% reduction in all-cause mortality, with a 5% type I error, 80% power, 1.21 design effect, 15% early pregnancy loss and 10% loss to follow-up. A mid-study DSMB analysis suggested a lower MR, leading the SS to be increased to 67,740. However, with no mortality difference evident at a DSMB meeting in Dec 2006, the trial was halted leaving 59,721 in the trial cohort.||0.99||0.05
91778051|NCT02667119|183437757|SUPERIORITY||F|4.75||||0.041|TWO_SIDED||||||ANCOVA|Controlled for baseline scores on the National Stressful Events PTSD Scale||Compared the two groups at 3 months post-baseline||||.041
91778052|NCT02667119|183437758|SUPERIORITY||F|6.89||||0.016|TWO_SIDED||||||ANCOVA|Controlled for baseline score on the National Stressful Events PTSD Scale||||||.016
91778053|NCT02667119|183437759|SUPERIORITY||t|-2.19||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
91778054|NCT02667119|183437760|SUPERIORITY||F|2.25||||0.148|TWO_SIDED|||||Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale|ANCOVA|||||||.148
91778055|NCT02667119|183437761|SUPERIORITY||F|4.64||||0.043|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale||||||.043
91778056|NCT02667119|183437762|SUPERIORITY||F|1.4||||0.25|TWO_SIDED|||||Controlling for baseline score on the Quality of Life Scale|ANCOVA|||||||.250
91778057|NCT02667119|183437763|SUPERIORITY||F|0.45||||0.508|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Quality of Life Scale||||||.508
91778058|NCT03818256|183437774|SUPERIORITY||Least Squares Mean Difference|0.11||||0.8511|TWO_SIDED|95.0|-1.03|1.24|||Mixed Models Analysis|||||1.24|-1.03|0.8511
91778059|NCT03818256|183437778|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8169|TWO_SIDED|95.0|0.15|4.474|||Regression, Logistic|||||4.474|0.150|0.8169
91778060|NCT03818256|183437779|SUPERIORITY||Location shift|0.175||||0.9285|TWO_SIDED|95.0|-2.86|2.78|||Wilcoxon rank-sum test|||||2.780|-2.860|0.9285
91778061|NCT03818256|183437780|SUPERIORITY||Least squares mean difference|0.007||||0.5669|TWO_SIDED|95.0|-0.018|0.033|||Mixed Models Analysis|||||0.033|-0.018|0.5669
91584169|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.82||0.6792|TWO_SIDED|95.0|-2.8|4.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||4.3|-2.8|0.6792
91584170|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|2.1||0.3983|TWO_SIDED|95.0|-5.9|2.4|||Mixed Model for Repeated Measures (MMRM)|||Week 5-- Emraclidine 15 mg versus Placebo||2.4|-5.9|0.3983
91584171|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.07||0.3859|TWO_SIDED|95.0|-2.3|5.9|||Mixed Model for Repeated Measures (MMRM)|||Week 5-- Emraclidine 30 mg versus Placebo||5.9|-2.3|0.3859
91584172|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.3||0.2925|TWO_SIDED|95.0|-7.0|2.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 6-- Emraclidine 15 mg versus Placebo||2.1|-7.0|0.2925
91584173|NCT05227703|183058795|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.27||0.3914|TWO_SIDED|95.0|-2.5|6.4|||Mixed Model for Repeated Measures (MMRM)|||Week 6-- Emraclidine 30 mg versus Placebo||6.4|-2.5|0.3914
91584174|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.073||0.0865|TWO_SIDED|95.0|-0.27|0.02|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 1-- Emraclidine 15 mg versus Placebo||0.02|-0.27|0.0865
91584175|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.072||0.9921|TWO_SIDED|95.0|-0.14|0.14|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||0.14|-0.14|0.9921
91613907|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247||||0.0013|TWO_SIDED|95.0|0.106|0.579|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.579|0.106|0.0013
91613908|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.0062|TWO_SIDED|95.0|0.931|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.931|0.0062
91778062|NCT00911170|183437786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.014|TWO_SIDED|95.0|0.19|0.86|||Cochran-Mantel-Haenszel|The p-value is adjusted for the randomization stratification factors (chemotherapy regimen, geographic region, disease stage).|Odds ratio adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|The primary hypothesis was that the percentage of participants treated with study chemotherapy and bevacizumab who experience grade 3/4 febrile neutropenia (FN) would be lower in participants randomized to the pegfilgrastim arm compared to placebo arm. The study was designed to have at least 90% power at the 2-sided 0.05 significance level to detect a 6% difference in incidence of grade 3/4 FN from 9% to 3%, which is approximately a 66.7% relative reduction.||0.86|0.19|0.014
91613909|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.002|TWO_SIDED|95.0|0.568|0.881|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.881|0.568|0.0020
91613910|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.434|||<|0.0001|TWO_SIDED|95.0|1.288|1.596|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.596|1.288|<0.0001
91646810|NCT03111407|183185260|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.6154|||||||t-test, 2 sided|||Knee Soceity Score Function 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 80.5 +/- 13.8 \[44\] (55.0, 80.0, 100.0), 95% C.I. (76.2, 84.7) Conventional group: 78.5 +/- 19.1 \[26\] (40.0, 80.0, 100.0),95% C.I. (70.8, 86.2)||||0.6154
91646811|NCT03111407|183185261|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4549|||||||t-test, 2 sided|||EQ-5D score 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 0.8 +/- 0.2 \[29\] (0.0, 1.0, 1.0), 95% C.I. (0.7, 0.9) Conventional group: 0.8 +/- 0.3 \[20\] (0.1, 0.8, 1.0), 95% C.I. (0.7, 0.9)||||0.4549
91584176|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.091||0.972|TWO_SIDED|95.0|-0.18|0.18|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 2-- Emraclidine 15 mg versus Placebo||0.18|-0.18|0.9720
91646812|NCT03496207|183185266|SUPERIORITY||Difference in Least Squares Means|-151.1|STANDARD_ERROR_OF_MEAN|49.53||0.003|TWO_SIDED|95.0|-249.59|-52.63|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-52.63|-249.59|0.0030
91646813|NCT03496207|183185266|SUPERIORITY||Difference in Least Squares Means|-269.4|STANDARD_ERROR_OF_MEAN|48.48|<|0.0001|TWO_SIDED|95.0|-365.81|-173.03|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-173.03|-365.81|<.0001
91646814|NCT03496207|183185267|SUPERIORITY||Difference in Least Squares Means|-13.9|STANDARD_ERROR_OF_MEAN|50.95||0.7851|TWO_SIDED|95.0|-113.85|86.06|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||86.06|-113.85|0.7851
91584177|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.089||0.6621|TWO_SIDED|95.0|-0.14|0.21|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||0.21|-0.14|0.6621
91584178|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.101||0.3617|TWO_SIDED|95.0|-0.29|0.11|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 3-- Emraclidine 15 mg versus Placebo||0.11|-0.29|0.3617
91646815|NCT03496207|183185268|SUPERIORITY||Multiple Imputation Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|57.45|<|0.0001|TWO_SIDED|95.0|-335.83|-110.49||Comparison of baseline and final value|ANCOVA||Standard multiple imputations are done with imputed values that are within the range of the minimum and maximum observed values using linear regression including baseline measurements.|||-110.49|-335.83|<.0001
91646816|NCT02756078|183185289|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|5.0|STANDARD_DEVIATION|1.796|||TWO_SIDED|98.0|1.3|8.73|||Bayesian hierarchical model|A 98% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||8.73|1.30|
91646817|NCT02756078|183185290|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|13.7|STANDARD_DEVIATION|1.701|||TWO_SIDED|95.0|10.34|17.05|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||17.05|10.34|
91646818|NCT02756078|183185291|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.37|STANDARD_DEVIATION|0.313|||TWO_SIDED|95.0|-1.0|0.25|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|||Mean difference was calculated as senofilcon A minus samfilcon A.|0.25|-1.00|
91646819|NCT02756078|183185292|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.06|STANDARD_DEVIATION|0.107|||TWO_SIDED|95.0|-0.27|0.16|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.16|-0.27|
91646820|NCT02756078|183185293|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|0.05|STANDARD_DEVIATION|0.261|||TWO_SIDED|95.0|-0.47|0.57|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.57|-0.47|
91708404|NCT03299101|183309716|SUPERIORITY||Mean Difference (Net)|28.55|STANDARD_ERROR_OF_MEAN|37.61||0.448|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.||||0.448
91708405|NCT03299101|183309717|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.||||0.419
91708406|NCT03299101|183309717|SUPERIORITY||Mean Difference (Net)|20.91|STANDARD_ERROR_OF_MEAN|27.03||0.439|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.||||0.439
91778063|NCT00911170|183437787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.704|TWO_SIDED|95.0|0.81|1.36|||Log Rank|P-values based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.36|0.81|0.704
91778064|NCT00911170|183437788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.552|TWO_SIDED|95.0|0.88|1.26|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.26|0.88|0.552
91778065|NCT00911170|183437789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.502|TWO_SIDED|95.0|0.88|1.29|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.29|0.88|0.502
91778066|NCT00911170|183437790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.683|TWO_SIDED|95.0|0.81|1.39|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \> 1.0 indicates a higher event rate for the pegfilgrastim arm relative to the placebo arm.|||1.39|0.81|0.683
91584179|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.098||0.5456|TWO_SIDED|95.0|-0.13|0.25|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.25|-0.13|0.5456
91584180|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.11||0.8459|TWO_SIDED|95.0|-0.24|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 4-- Emraclidine 15 mg versus Placebo||0.19|-0.24|0.8459
91584181|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.108||0.3922|TWO_SIDED|95.0|-0.12|0.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||0.30|-0.12|0.3922
91584182|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.122||0.2915|TWO_SIDED|95.0|-0.37|0.11|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 5-- Emraclidine 15 mg versus Placebo||0.11|-0.37|0.2915
91584183|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4425|TWO_SIDED|95.0|-0.14|0.33|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||0.33|-0.14|0.4425
91584184|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.1165|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 6-- Emraclidine 15 mg versus Placebo||0.05|-0.48|0.1165
91584185|NCT05227703|183058796|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.134||0.8265|TWO_SIDED|95.0|-0.23|0.29|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.29|-0.23|0.8265
91708407|NCT03299101|183309717|SUPERIORITY||Mean Difference (Net)|47.67|STANDARD_ERROR_OF_MEAN|26.19||0.069|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.||||0.069
91708408|NCT03299101|183309717|SUPERIORITY||Mean Difference (Net)|37.11|STANDARD_ERROR_OF_MEAN|37.96||0.328|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.||||0.328
91778067|NCT00911170|183437791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.312||95.0|0.29|1.49|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||1.49|0.29|0.312
91778068|NCT00911170|183437792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|||<|0.001||95.0|0.1|0.32|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.32|0.10|<.001
91778069|NCT00911170|183437793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.13|0.56|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.56|0.13|<.001
91778070|NCT02677493|183437799|EQUIVALENCE|"All statistical significance testing was performed at a two-sided significance level (α) of 5%.~Exceptionally, non-inferiority was tested at a one-sided CI of 97.5%."||||||0.09135|||||||ANCOVA|||To evaluate if the seroconversion (SCR) and seroprotection (SPR) rates on Day 28 after vaccination of IL-YANG Quadrivalent Influenza Vaccine Inj. meet the following criteria in all age groups of healthy male and female adults at the age of 19 or older.||||0.09135
91778071|NCT03591406|183437837|NON_INFERIORITY|Pre-defined non-inferiority margin of -15%|Difference in proportions|1.12|||||TWO_SIDED|95.0|-2.15|4.71|||||2-sided 95% Confidence Interval (CI) was computed using the Wilson score method with continuity correction described by Newcombe.|||4.71|-2.15|
91778072|NCT01389596|183437850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.2577|TWO_SIDED|95.0|-0.29|0.08|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||0.08|-0.29|0.2577
91778073|NCT01389596|183437850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0185|TWO_SIDED|95.0|-0.41|-0.04|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||-0.04|-0.41|0.0185
91778074|NCT01389596|183437851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.8024|TWO_SIDED|95.0|0.528|2.03|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||2.030|0.528|0.8024
91778075|NCT01389596|183437851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.636||||0.0092|TWO_SIDED|95.0|0.851|3.147|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||3.147|0.851|0.0092
91778076|NCT00904033|183437919|OTHER|||||||0.86|||||||ANCOVA|Main Effects Results only for No Exercise vs Exercise||||||0.86
91778077|NCT00904033|183437920|OTHER|||||||0.19|||||||ANCOVA|||||||0.19
91778078|NCT00904033|183437921|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
91778079|NCT00904033|183437922|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91778080|NCT00904033|183437923|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
91778081|NCT00904033|183437924|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
91778082|NCT00904033|183437925|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
91778083|NCT00904033|183437926|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
91778084|NCT01357850|183437927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0119||||0.7873|TWO_SIDED|95.0|-0.0768|0.1005|||ANOVA|||||0.1005|-0.0768|0.7873
91778085|NCT01357850|183437927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0678||||0.0499|TWO_SIDED|95.0|0.0|0.1356|||ANOVA|||||0.1356|0.0000|0.0499
91778086|NCT01357850|183437927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0467||||0.1666|TWO_SIDED|95.0|-0.0204|0.1137|||ANOVA|||||0.1137|-0.0204|0.1666
91778087|NCT01357850|183437928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.89||||0.9343|TWO_SIDED|95.0|-3172.05|3441.83|||ANOVA|||||3441.83|-3172.05|0.9343
91778088|NCT01357850|183437928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1278.77||||0.3375|TWO_SIDED|95.0|-1398.13|3955.68|||ANOVA|||||3955.68|-1398.13|0.3375
91778089|NCT01357850|183437928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|772.7||||0.5582|TWO_SIDED|95.0|-1887.77|3433.17|||ANOVA|||||3433.17|-1887.77|0.5582
91778090|NCT01357850|183437929|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.06||||0.2256|TWO_SIDED|95.0|-5.43|1.3|||ANOVA|||||1.30|-5.43|0.2256
91778091|NCT01357850|183437929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.5647|TWO_SIDED|95.0|-4.22|2.32|||ANOVA|||||2.32|-4.22|0.5647
91778092|NCT01357850|183437929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.8942|TWO_SIDED|95.0|-2.44|2.79|||ANOVA|||||2.79|-2.44|0.8942
91778093|NCT03077412|183437962|SUPERIORITY||Risk Difference in Percentages|22.1|||||TWO_SIDED|90.0|-9.9|50.0|||||The 90% exact confidence interval (CI) was calculated based on binomial distribution (Clopper-Pearson method).|||50.0|-9.9|
91778094|NCT03077412|183437962|SUPERIORITY||Risk Difference in Percentages|4.2|||||TWO_SIDED|90.0|-26.5|34.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||34.3|-26.5|
91778095|NCT03077412|183437963|SUPERIORITY||Risk Difference in Percentages|30.4|||||TWO_SIDED|90.0|-1.3|57.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||57.3|-1.3|
91778096|NCT03077412|183437963|SUPERIORITY||Risk Difference in Percentages|8.3|||||TWO_SIDED|90.0|-22.5|38.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||38.1|-22.5|
91708409|NCT03299101|183309718|SUPERIORITY|||||||0.196|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.||||0.196
91584186|NCT05227703|183058797|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and baseline value as a covariate.|Odds Ratio (OR)|1.26||||0.4597|TWO_SIDED|95.0|0.68|2.33|||Regression, Logistic|||Emraclidine 15 mg versus Placebo||2.33|0.68|0.4597
91584187|NCT05227703|183058797|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and baseline value as a covariate.|Odds Ratio (OR)|0.57||||0.1205|TWO_SIDED|95.0|0.28|1.16|||Regression, Logistic|||Emraclidine 30 mg versus Placebo||1.16|0.28|0.1205
91584188|NCT05227703|183058804|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0493|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 3-- Emraclidine 15 mg versus Placebo||0.2|0.0|0.0493
91584189|NCT05227703|183058804|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0226|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|0.0|0.0226
91708410|NCT03299101|183309718|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.||||0.562
91584190|NCT05227703|183058804|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.6845|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 6-- Emraclidine 15 mg versus Placebo||0.1|-0.1|0.6845
91584191|NCT05227703|183058804|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.895|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|0.8950
91584192|NCT05227703|183058805|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5073|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 3-- Emraclidine 15 mg versus Placebo||0.1|-0.1|0.5073
91584193|NCT05227703|183058805|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.465|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.1|-0.1|0.4650
91584194|NCT05227703|183058805|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0672|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 6-- Emraclidine 15 mg versus Placebo||0.0|-0.1|0.0672
91584195|NCT05227703|183058805|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.803|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|0.8030
91584196|NCT05227703|183058806|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.8259|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 3-- Emraclidine 15 mg versus Placebo||0.1|-0.1|0.8259
91646821|NCT02756078|183185294|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.05|STANDARD_DEVIATION|0.159|||TWO_SIDED|95.0|-0.36|0.26|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A.|||0.26|-0.36|
91778097|NCT03077412|183437964|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.64|2.49|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.49|0.64|
91778098|NCT03077412|183437964|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.47|1.75|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||1.75|0.47|
91778099|NCT03077412|183437965|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|90.0|0.87|4.01|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||4.01|0.87|
91778100|NCT03077412|183437965|SUPERIORITY||Hazard Ratio (HR)|1.37|||||TWO_SIDED|90.0|0.65|2.92|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.92|0.65|
91778101|NCT03077412|183437966|SUPERIORITY||Risk Difference in Percentages|-18.6|||||TWO_SIDED|90.0|-55.6|21.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||21.3|-55.6|
91778102|NCT03077412|183437966|SUPERIORITY||Risk Difference in Percentages|-13.2|||||TWO_SIDED|90.0|-51.0|24.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||24.1|-51.0|
91778103|NCT03762993|183438000|OTHER|Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.001||||||P-value is for the effect of time. A priori significance level set at .05|Mixed Models Analysis|||||||<0.001
91778104|NCT03762993|183438001|OTHER|Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.01||||||P-value represents effect of group. A priori threshold for significance set at .05|Mixed Models Analysis|||||||<0.01
91778105|NCT03038100|183438004|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2785|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2785
91778106|NCT03038100|183438005|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0376|TWO_SIDED|95.0|0.65|0.99|||Log Rank|||||0.99|0.65|0.0376
91521127|NCT02954354|182917019|SUPERIORITY|||||||0.2505||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.2505
91521128|NCT02954354|182917019|SUPERIORITY|||||||0.419||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4190
91521129|NCT02954354|182917019|SUPERIORITY|||||||0.0095||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0095
91521130|NCT02954354|182917019|SUPERIORITY|||||||0.7393||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.7393
91521131|NCT02954354|182917019|SUPERIORITY|||||||0.0049||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0049
91521132|NCT02954354|182917020|SUPERIORITY|||||||0.2266||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.2266
91521133|NCT02954354|182917020|SUPERIORITY|||||||0.1379||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.1379
91521134|NCT02954354|182917020|SUPERIORITY|||||||0.5479||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.5479
91521135|NCT02954354|182917020|SUPERIORITY|||||||0.0241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0241
91521136|NCT02954354|182917020|SUPERIORITY|||||||0.0898||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0898
91521137|NCT02954354|182917020|SUPERIORITY|||||||0.2548||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.2548
91521138|NCT02954354|182917021|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
91521139|NCT02954354|182917021|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
91521140|NCT02954354|182917021|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0008
91521141|NCT02954354|182917021|SUPERIORITY|||||||0.0132||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0132
91521142|NCT02954354|182917021|SUPERIORITY|||||||0.9307||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9307
91521143|NCT02954354|182917021|SUPERIORITY|||||||0.1677||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.1677
91521144|NCT02954354|182917022|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
91521145|NCT02954354|182917022|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
91521146|NCT02954354|182917022|SUPERIORITY|||||||0.801||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.8010
91521147|NCT02954354|182917022|SUPERIORITY|||||||0.9451||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.9451
91584197|NCT05227703|183058806|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.5936|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.0|-0.1|0.5936
91584198|NCT05227703|183058806|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0253|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 15 mg - Placebo|Week 6-- Emraclidine 15 mg versus Placebo||0.1|0.0|0.0253
91778107|NCT03038100|183438006|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3432|TWO_SIDED|95.0|0.78|1.09|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).||1.09|0.78|0.3432
91778108|NCT03038100|183438007|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83||||0.1316|TWO_SIDED|95.0|0.66|1.06|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).||1.06|0.66|0.1316
91778109|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.9096|TWO_SIDED|95.0|0.58|1.62|||Cochran-Mantel-Haenszel|||Emotional Functioning, Presurgical/Surgery||1.62|0.58|0.9096
91778110|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.4662|TWO_SIDED|95.0|0.73|2.01|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 4 Day 1||2.01|0.73|0.4662
91778111|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.5237|TWO_SIDED|95.0|0.51|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 6 Day 1||1.40|0.51|0.5237
91778112|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.25||||0.3826|TWO_SIDED|95.0|0.76|2.07|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||2.07|0.76|0.3826
91778113|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.56|1.76|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.76|0.56|0.9893
91778114|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.6892|TWO_SIDED|95.0|0.49|1.61|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.61|0.49|0.6892
91778115|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.1324|TWO_SIDED|95.0|0.3|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.17|0.30|0.1324
91778116|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.9176|TWO_SIDED|95.0|0.62|1.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/Early Termination Visit||1.70|0.62|0.9176
91778117|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7861|TWO_SIDED|95.0|0.5|1.68|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.68|0.50|0.7861
91778118|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.31||||0.4539|TWO_SIDED|95.0|0.65|2.65|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||2.65|0.65|0.4539
91778119|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.71||||0.4849|TWO_SIDED|95.0|0.27|1.86|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.86|0.27|0.4849
91778120|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.747|TWO_SIDED|95.0|0.19|3.34|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||3.34|0.19|0.7470
91778121|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.0896|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.0896
91778122|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Emotional Functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
91778123|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7347|TWO_SIDED|95.0|0.56|1.5|||Cochran-Mantel-Haenszel|||Physical Functioning, Presurgical/Surgery||1.50|0.56|0.7347
91778124|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.56||||0.0479|TWO_SIDED|95.0|0.32|1.0|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 4 Day 1||1.00|0.32|0.0479
91778125|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.61||||0.0712|TWO_SIDED|95.0|0.36|1.05|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 6 Day 1||1.05|0.36|0.0712
91778126|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8168|TWO_SIDED|95.0|0.56|1.58|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 8 Day 1||1.58|0.56|0.8168
91778127|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.6417|TWO_SIDED|95.0|0.5|1.52|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 12 Day 1||1.52|0.50|0.6417
91778128|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8821|TWO_SIDED|95.0|0.53|1.72|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 16 Day 1||1.72|0.53|0.8821
91778129|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.2158|TWO_SIDED|95.0|0.32|1.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 20 Day 1||1.30|0.32|0.2158
91521148|NCT02954354|182917022|SUPERIORITY|||||||0.2256||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.2256
91778130|NCT03038100|183438013|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4762|TWO_SIDED|95.0|0.51|1.37|||Cochran-Mantel-Haenszel|||Physical Functioning, Completion of Treatment/Early Termination Visit||1.37|0.51|0.4762
91778131|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.7585|TWO_SIDED|95.0|0.61|1.96|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 3 Months||1.96|0.61|0.7585
91778132|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9985|TWO_SIDED|95.0|0.52|1.93|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 6 Months||1.93|0.52|0.9985
91778133|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.07||||0.1067|TWO_SIDED|95.0|0.85|5.06|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 9 Months||5.06|0.85|0.1067
91778134|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.42||||0.6171|TWO_SIDED|95.0|0.36|5.61|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 12 Months||5.61|0.36|0.6171
91778135|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 18 Months||23.57|0.08|0.8084
91778136|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-50.0||||0.3173|TWO_SIDED|95.0|-100.0|94.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 24 Months||94.30|-100.00|0.3173
91778137|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6802|TWO_SIDED|95.0|0.69|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Presurgical/Surgery||1.77|0.69|0.6802
91778138|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.347|TWO_SIDED|95.0|0.48|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 4 Day 1||1.29|0.48|0.3470
91521149|NCT02954354|182917022|SUPERIORITY|||||||0.3332||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3332
91521150|NCT02954354|182917023|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
91778139|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.5564|TWO_SIDED|95.0|0.53|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 6 Day 1||1.41|0.53|0.5564
91778140|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.5|TWO_SIDED|95.0|0.72|1.99|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.99|0.72|0.5000
91778141|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9778|TWO_SIDED|95.0|0.57|1.78|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.78|0.57|0.9778
91778142|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6005|TWO_SIDED|95.0|0.65|2.12|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||2.12|0.65|0.6005
91778143|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.5|2.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||2.00|0.50|0.9900
91778144|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.32||||0.2634|TWO_SIDED|95.0|0.81|2.15|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/Early Termination Visit||2.15|0.81|0.2634
91778145|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.964|TWO_SIDED|95.0|0.56|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.56|0.9640
91778146|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.76||||0.4117|TWO_SIDED|95.0|0.4|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.46|0.40|0.4117
91778147|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.3505|TWO_SIDED|95.0|0.63|3.62|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||3.62|0.63|0.3505
91584199|NCT05227703|183058806|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.271|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|0.0|0.2710
91584200|NCT03373201|183058822|SUPERIORITY||Difference between LS means|60.3|||<|0.0001|TWO_SIDED|95.0|44.0|76.7|||ANOVA|||||76.7|44.0|<.0001
91584201|NCT03373201|183058823|SUPERIORITY||Difference between LS Means.|85.5|||<|0.0001|TWO_SIDED|95.0|64.3|106.6|||ANOVA|||||106.6|64.3|<.0001
91584202|NCT03373201|183058824|SUPERIORITY||Difference between LS means|-15.1|||<|0.0001|TWO_SIDED|95.0|-26.2|-4.0|||ANOVA|||||-4.0|-26.2|<.0001
91584203|NCT03373201|183058825|SUPERIORITY||Difference between LS means|-74.6|||<|0.0001|TWO_SIDED|95.0|-94.8|-54.3|||ANOVA|||||-54.3|-94.8|<.0001
91584204|NCT03373201|183058826|SUPERIORITY||Difference between LS Means.|-0.5||||0.0083|TWO_SIDED|95.0|-0.9|-0.1|||ANOVA|||||-0.1|-0.9|0.0083
91584205|NCT03373201|183058827|SUPERIORITY||Difference between LS Means.|6.6||||0.0099|TWO_SIDED|95.0|1.6|11.6|||ANOVA|||||11.6|1.6|0.0099
91584206|NCT03464097|183058828|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0539|TWO_SIDED|95.0|0.99|2.55|||Cochran-Mantel-Haenszel|||||2.55|0.99|0.0539
91584207|NCT03464097|183058829|SUPERIORITY||Odds Ratio (OR)|1.51||||0.1503|TWO_SIDED|95.0|0.86|2.65|||Cochran-Mantel-Haenszel|||||2.65|0.86|0.1503
91584208|NCT03464097|183058830|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1121|TWO_SIDED|95.0|0.92|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.92|0.1121
91778148|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.28||||0.2439|TWO_SIDED|95.0|0.55|9.45|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||9.45|0.55|0.2439
91584209|NCT03464097|183058831|SUPERIORITY||Odds Ratio (OR)|1.46||||0.1163|TWO_SIDED|95.0|0.91|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.91|0.1163
91584210|NCT03464097|183058832|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0561|TWO_SIDED|95.0|0.98|3.2|||Cochran-Mantel-Haenszel|||||3.20|0.98|0.0561
91584211|NCT03464097|183058833|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5061|TWO_SIDED|95.0|0.6|2.86|||Cochran-Mantel-Haenszel|||||2.86|0.60|0.5061
91584212|NCT03464097|183058834|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1179|TWO_SIDED|95.0|0.82|5.44|||Cochran-Mantel-Haenszel|||||5.44|0.82|0.1179
91584213|NCT03464097|183058835|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0769|TWO_SIDED|95.0|0.94|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.94|0.0769
91584214|NCT03464097|183058836|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0623|TWO_SIDED|95.0|0.92|7.98|||Cochran-Mantel-Haenszel|||||7.98|0.92|0.0623
91584215|NCT03464097|183058837|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1162|TWO_SIDED|95.0|0.89|3.0|||Cochran-Mantel-Haenszel|||||3.00|0.89|0.1162
91584216|NCT03464097|183058838|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2143|TWO_SIDED|95.0|0.85|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.85|0.2143
91584217|NCT03464097|183058839|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0663|TWO_SIDED|95.0|0.97|2.57|||Cochran-Mantel-Haenszel|||||2.57|0.97|0.0663
91584218|NCT03464097|183058840|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0774|TWO_SIDED|95.0|0.78|18.64|||Cochran-Mantel-Haenszel|||||18.64|0.78|0.0774
91584219|NCT03464097|183058842|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0308|TWO_SIDED|95.0|1.06|3.33|||Cochran-Mantel-Haenszel|||||3.33|1.06|0.0308
91584220|NCT03464097|183058843|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8745|TWO_SIDED|95.0|0.57|1.95|||Cochran-Mantel-Haenszel|||||1.95|0.57|0.8745
91584221|NCT03464097|183058844|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0361|TWO_SIDED|95.0|1.04|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.04|0.0361
91584222|NCT03035201|183058845|OTHER|two-tailed test of the null hypothesis of no differences between groups.|Mean from linear contrast|0.03|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|-0.02|0.08||Not adjusted|Mixed Models Analysis||Marginal effect of cocoa flavonal versus cocoa placebo based on the mean difference between linear contrasts.|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol.|0.08|-0.02|<0.05
91584223|NCT03035201|183058846|EQUIVALENCE|two-tailed test of the null hypothesis of no differences between groups.|Mean difference of linear contrasts|0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.02|0.12||Not adjusted|Wald test||Marginal effects of multivitamin versus multivitamin placebo|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol|0.12|0.02|<0.05
91584224|NCT03035201|183058847|EQUIVALENCE|Proportional hazards regression -- unadjusted two-sided test|Hazard Ratio (HR)|0.76||||0.15|TWO_SIDED|95.0|0.52|1.11||Not adjusted|Regression, Cox||Comparison group is placebo|||1.11|0.52|0.15
91778149|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.1573|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.1573
91778150|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-94.30|
91778151|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.182|TWO_SIDED|95.0|0.45|1.16|||Cochran-Mantel-Haenszel|||Role Functioning, Presurgical/Surgery||1.16|0.45|0.1820
91778152|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.47||||0.0046|TWO_SIDED|95.0|0.28|0.8|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 4 Day 1||0.80|0.28|0.0046
91778153|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.0361|TWO_SIDED|95.0|0.36|0.97|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 6 Day 1||0.97|0.36|0.0361
91778154|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.0848|TWO_SIDED|95.0|0.39|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.06|0.39|0.0848
91778155|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1224|TWO_SIDED|95.0|0.37|1.13|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.13|0.37|0.1224
91778156|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.3127|TWO_SIDED|95.0|0.41|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.33|0.41|0.3127
91778157|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.6065|TWO_SIDED|95.0|0.42|1.65|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.65|0.42|0.6065
91584225|NCT03035201|183058848|EQUIVALENCE|Unadjusted 2-sided test|Cox Proportional Hazard|0.91||||0.62|TWO_SIDED|95.0|0.63|1.32||Unadjusted|Regression, Cox||Comparison group is placebo.|||1.32|0.63|0.62
91584226|NCT03035201|183058849|EQUIVALENCE|Cocoa Flavonal minus Placebo|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED|95.0|-0.02|0.08||Unadjusted|Mixed Models Analysis|Wald test comparing linear contrasts|Cocoa Flavonal minus placebo|||0.08|-0.02|0.24
91584227|NCT03035201|183058850|EQUIVALENCE|two-sided|Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.04|0.09||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts: cocoa flavonal minus placebo|Cocoa flavonal minus placebo|Unadjusted 2-tailed test||0.09|-0.04|0.41
91584228|NCT03035201|183058851|EQUIVALENCE|2 sided test, multivitamin minus placebo|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.02|TWO_SIDED|95.0|0.01|0.11||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|2-sided test, unadjusted||0.11|0.01|0.02
91584229|NCT03035201|183058852|EQUIVALENCE|2-sided, unadjusted|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.04|TWO_SIDED|95.0|0.002|0.126||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|Multivitamin minus placebo||0.126|0.002|0.04
91584230|NCT02390050|183058853|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.34|-0.76|< 0.0001
91584231|NCT02390050|183058853|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.47|-0.89|< 0.0001
91584232|NCT02390050|183058853|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.59|-1.01|< 0.0001
91584233|NCT02390050|183058854|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1308|TWO_SIDED|95.0|0.8|5.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 5 mg bexagliflozin group was compared to placebo group.||5.3|0.8|0.1308
91584234|NCT02390050|183058854|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1294|TWO_SIDED|95.0|0.8|5.1|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 10 mg bexagliflozin group was compared to placebo group.||5.1|0.8|0.1294
91584235|NCT02390050|183058854|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0015|TWO_SIDED|95.0|1.7|10.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 20 mg bexagliflozin group was compared to placebo group.||10.3|1.7|0.0015
91584236|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-0.74|||||TWO_SIDED|95.0|-1.13|-0.36||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.36|-1.13|
91708411|NCT03299101|183309718|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.087|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.||||0.087
91708412|NCT03299101|183309718|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.226|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.||||0.226
91708413|NCT03299101|183309719|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.||||0.001
91708414|NCT03299101|183309719|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.||||0.001
91708415|NCT03299101|183309719|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests|Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.||||0.001
91708416|NCT03299101|183309719|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.874|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.||||0.874
91708417|NCT03299101|183309720|SUPERIORITY|||||||0.854|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.||||0.854
91584237|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-0.76|||||TWO_SIDED|95.0|-1.15|-0.38||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.38|-1.15|
91778158|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2173|TWO_SIDED|95.0|0.45|1.2|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.20|0.45|0.2173
91778159|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1316|TWO_SIDED|95.0|0.35|1.15|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.15|0.35|0.1316
91584238|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-0.99|||||TWO_SIDED|95.0|-1.38|-0.61||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.61|-1.38|
91584239|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-1.53|-0.52||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.52|-1.53|
91584240|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-1.45|||||TWO_SIDED|95.0|-1.95|-0.94||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.94|-1.95|
91584241|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-1.51|||||TWO_SIDED|95.0|-2.01|-1.01||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.01|-2.01|
91584242|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.12|-0.76||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.76|-2.12|< 0.0001
91584243|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.26|-0.91||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.91|-2.26|< 0.0001
91584244|NCT02390050|183058855|SUPERIORITY||Difference of LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.08||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.08|-2.43|< 0.0001
91584245|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-0.48|||||TWO_SIDED|95.0|-0.9|-0.06||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.06|-0.90|
91584246|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-0.9|||||TWO_SIDED|95.0|-1.31|-0.48||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.48|-1.31|
91584247|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-1.04|||||TWO_SIDED|95.0|-1.45|-0.62||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.62|-1.45|
91584248|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-0.93|||||TWO_SIDED|95.0|-1.39|-0.48||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.48|-1.39|
91584249|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-1.17|||||TWO_SIDED|95.0|-1.62|-0.72||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.72|-1.62|
91584250|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-1.1|||||TWO_SIDED|95.0|-1.55|-0.65||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.65|-1.55|
91584251|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-0.85||||0.0002|TWO_SIDED|95.0|-1.29|-0.41||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.41|-1.29|0.0002
91778160|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.7678|TWO_SIDED|95.0|0.46|1.76|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.76|0.46|0.7678
91584252|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.6||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.60|-1.49|< 0.0001
91584253|NCT02390050|183058856|SUPERIORITY||Difference of LS Means|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.52|-0.63||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.63|-1.52|< 0.0001
91584254|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-0.19|||||TWO_SIDED|95.0|-3.9|3.51||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||3.51|-3.90|
91584255|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-2.41|||||TWO_SIDED|95.0|-6.09|1.28||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.28|-6.09|
91584256|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-4.25|||||TWO_SIDED|95.0|-7.93|-0.58||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.58|-7.93|
91584257|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-0.18|||||TWO_SIDED|95.0|-2.5|2.13||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.13|-2.50|
91778161|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.7331|TWO_SIDED|95.0|0.34|2.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||2.14|0.34|0.7331
91778162|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.83||||0.1235|TWO_SIDED|95.0|0.73|10.92|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||10.92|0.73|0.1235
91778163|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|0.0|||||TWO_SIDED|95.0|-84.09|84.09||||||Role functioning, Post-Treatment Follow Up 18 Months||84.09|-84.09|
91708418|NCT03299101|183309720|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.32||0.298|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.||||0.298
91521151|NCT02954354|182917023|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
91708419|NCT03299101|183309720|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.31||0.684|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.||||0.684
91708420|NCT03299101|183309720|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.33||0.485|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.||||0.485
91708421|NCT03299101|183309721|SUPERIORITY|||||||0.067|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in RAI across all 4 time points.||||0.067
91708422|NCT03299101|183309721|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.22||0.089|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and day of surgery.||||0.089
91708423|NCT03299101|183309721|SUPERIORITY||Mean Difference (Net)|4.37|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.||||0.006
91708424|NCT03299101|183309721|SUPERIORITY||Mean Difference (Net)|1.98|STANDARD_ERROR_OF_MEAN|1.62||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.||||0.221
91708425|NCT03299101|183309722|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SGA across all 4 time points.||||0.860
91778164|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
91778165|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.65|1.78|||Cochran-Mantel-Haenszel|||Social functioning, Presurgical/Surgery||1.78|0.65|0.7869
91778166|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.2502|TWO_SIDED|95.0|0.43|1.25|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 4 Day 1||1.25|0.43|0.2502
91778167|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.5066|TWO_SIDED|95.0|0.5|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 6 Day 1||1.41|0.50|0.5066
91778168|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8124|TWO_SIDED|95.0|0.56|1.59|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.59|0.56|0.8124
91778169|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.4656|TWO_SIDED|95.0|0.7|2.17|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||2.17|0.70|0.4656
91778170|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6725|TWO_SIDED|95.0|0.62|2.12|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||2.12|0.62|0.6725
91778171|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.578|TWO_SIDED|95.0|0.41|1.64|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.64|0.41|0.5780
91778172|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7611|TWO_SIDED|95.0|0.66|1.76|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/Early Termination Visit||1.76|0.66|0.7611
91778173|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.7588|TWO_SIDED|95.0|0.62|1.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.94|0.62|0.7588
91778174|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.1428|TWO_SIDED|95.0|0.3|1.19|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.19|0.30|0.1428
91778175|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9802|TWO_SIDED|95.0|0.41|2.39|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||2.39|0.41|0.9802
91778176|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.34||||0.1967|TWO_SIDED|95.0|0.63|8.7|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||8.70|0.63|0.1967
91778177|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Respnders|8.33||||0.4795|TWO_SIDED|95.0|-69.28|85.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||85.94|-69.28|0.4795
91778178|NCT03038100|183438013|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
91778179|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6651|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.25|0.70|0.6651
91778180|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9927|TWO_SIDED|95.0|0.75|1.34|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.34|0.75|0.9927
91778181|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.8209|TWO_SIDED|95.0|0.77|1.39|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.39|0.77|0.8209
91584258|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-1.74|||||TWO_SIDED|95.0|-4.03|0.56||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.56|-4.03|
91646822|NCT02756078|183185295|NON_INFERIORITY|A non-inferiority margin of 0.67 was used.|Posterior odds ratio|1.35|STANDARD_DEVIATION|0.203|||TWO_SIDED|95.0|0.99|1.79|||Bayesian multinomial model|A 95% credible interval for the posterior odds ratio was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Odds ratio was calculated as senofilcon A over samfilcon A.|||1.79|0.99|
91646823|NCT00810615|183185297|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|A repeated measures model was designed so as to incorporate the adjust for the repeated (dependent) measures within individuals over time.||ANCOVA, baseline measurement was considered as a covariate and group (sham or 2.4 ATA), treatment (15 treatments, 30 treatments, and 6 weeks) as well as the interaction between group and treatment were considered as the independent variables.||||0.05
91646824|NCT00810615|183185309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5455||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with one significant event (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
91646825|NCT00810615|183185310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with two significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
91646826|NCT00810615|183185311|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1111||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with three significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
91584259|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-2.15|||||TWO_SIDED|95.0|-4.45|0.14||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.14|-4.45|
91646827|NCT00810615|183185312|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with four or more significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
91646828|NCT02618772|183185318|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
91646829|NCT02618772|183185319|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
91646830|NCT02618772|183185320|SUPERIORITY_OR_OTHER|||||||0.151||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.151
91778182|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.6507|TWO_SIDED|95.0|0.79|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.45|0.79|0.6507
91646831|NCT02618772|183185320|SUPERIORITY_OR_OTHER|||||||0.02||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.020
91646832|NCT02618772|183185320|SUPERIORITY_OR_OTHER|||||||0.198||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.198
91646833|NCT02618772|183185320|SUPERIORITY_OR_OTHER|||||||0.006||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.006
91646834|NCT02618772|183185321|SUPERIORITY_OR_OTHER|||||||0.185||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.185
91584260|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-4.57|2.9||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.90|-4.57|
91584261|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-3.39|||||TWO_SIDED|95.0|-7.12|0.34||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.34|-7.12|
91646835|NCT02618772|183185321|SUPERIORITY_OR_OTHER|||||||0.011||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.011
91646836|NCT02618772|183185321|SUPERIORITY_OR_OTHER|||||||0.191||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.191
91646837|NCT02618772|183185321|SUPERIORITY_OR_OTHER|||||||0.008||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.008
91646838|NCT02618772|183185322|SUPERIORITY_OR_OTHER|||||||0.004||||||This p value is a t-test of the Post STAI minus Pre STAI variable.|t-test, 2 sided|||||||0.004
91646839|NCT02618772|183185323|SUPERIORITY_OR_OTHER|||||||0.015||||||This p value is in reference to the t-test performed for STAI Post Minus STAI Pre.|t-test, 2 sided|||||||0.015
91646840|NCT02618772|183185324|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
91646841|NCT02618772|183185325|SUPERIORITY_OR_OTHER|||||||0.086|||||||t-test, 2 sided|||||||0.086
91646842|NCT02618772|183185326|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91646843|NCT02618772|183185327|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91778183|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.2596|TWO_SIDED|95.0|0.87|1.67|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.67|0.87|0.2596
91778184|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.6532|TWO_SIDED|95.0|0.75|1.58|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.58|0.75|0.6532
91778185|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7592|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion Of Treatment/ Early Termination Visit||1.45|0.76|0.7592
91778186|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.7424|TWO_SIDED|95.0|0.62|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.40|0.62|0.7424
91778187|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.1912|TWO_SIDED|95.0|0.85|2.19|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||2.19|0.85|0.1912
91778188|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.5526|TWO_SIDED|95.0|0.45|1.53|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||1.53|0.45|0.5526
91778189|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.3609|TWO_SIDED|95.0|0.32|1.52|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||1.52|0.32|0.3609
91584262|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-2.51|||||TWO_SIDED|95.0|-6.21|1.2||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.20|-6.21|
91584263|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|0.25|||||TWO_SIDED|95.0|-2.15|2.66||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.66|-2.15|
91584264|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-3.42|1.38||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.38|-3.42|
91584265|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-3.22|1.54||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.54|-3.22|
91584266|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-2.16||||0.3001|TWO_SIDED|95.0|-6.26|1.94||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||1.94|-6.26|0.3001
91584267|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-4.41||||0.0343|TWO_SIDED|95.0|-8.49|-0.33||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.33|-8.49|0.0343
91584268|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-3.83||||0.0679|TWO_SIDED|95.0|-7.95|0.28|||ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.28|-7.95|0.0679
91584269|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-2.24||||0.0776|TWO_SIDED|95.0|-4.73|0.25||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.25|-4.73|0.0776
91584270|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-1.47||||0.2415|TWO_SIDED|95.0|-3.95|1.0||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.00|-3.95|0.2415
91584271|NCT02390050|183058857|SUPERIORITY||Difference of LS Means|-2.04||||0.1086|TWO_SIDED|95.0|-4.54|0.46||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.46|-4.54|0.1086
91584272|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.09|||||TWO_SIDED|95.0|-0.2|0.03||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.03|-0.20|
91584273|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.02|-0.24|
91584274|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.02|-0.24|
91584275|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.45|||||TWO_SIDED|95.0|-0.62|-0.28||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.28|-0.62|
91584276|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.49|||||TWO_SIDED|95.0|-0.66|-0.32||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.32|-0.66|
91584277|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.53|||||TWO_SIDED|95.0|-0.7|-0.36||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.36|-0.70|
91584278|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.34|-0.76|< 0.0001
91584279|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.47|-0.89|< 0.0001
91584280|NCT02390050|183058858|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.59|-1.01|< 0.0001
91646844|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.069|TWO_SIDED|95.0|-0.06|1.65||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.|||1.65|-0.06|0.069
91646845|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.43|TWO_SIDED|95.0|-0.55|1.29||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.|||1.29|-0.55|0.43
91646846|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.76|TWO_SIDED|95.0|-1.05|0.77||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.|||0.77|-1.05|0.76
91646847|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.41|TWO_SIDED|95.0|-1.27|0.53||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.|||0.53|-1.27|0.41
91646848|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.039|TWO_SIDED|95.0|-1.85|-0.05||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.|||-0.05|-1.85|0.039
91646849|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.15|TWO_SIDED|95.0|-1.65|0.26||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.|||0.26|-1.65|0.15
91646850|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.15|TWO_SIDED|95.0|-1.68|0.25||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.|||0.25|-1.68|0.15
91646851|NCT02058368|183185332|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.004|TWO_SIDED|95.0|-2.4|-0.46||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.|||-0.46|-2.40|0.004
91584281|NCT03727438|183058860|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-3.7|||<|0.01|TWO_SIDED|95.0|-5.0|-2.4||alpha=.05|Mixed Models Analysis|Model parameters included a common intercept (baseline means constrained to be equal), stratification variables, timepoint, and arm by timepoint.||"Analyses were conducted according to the intention-to-treat principle. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Our modeling estimation approach was conducted with full-likelihood methods, providing unbiased treatment effect estimates under a missing-data framework known as missing at random (MAR)."||-2.4|-5.0|<0.01
91646852|NCT02058368|183185333|SUPERIORITY||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-25.9|-20.1||Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.|||-20.1|-25.9|<.001
91646853|NCT02058368|183185333|SUPERIORITY|Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-31.7|-25.2|||General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24|||-25.2|-31.7|<.001
91584282|NCT03727438|183058861|EQUIVALENCE|alpha= .05|Mean Difference (Final Values)|-19.6|||<|0.01|TWO_SIDED|95.0|-26.7|-12.5||alpha = 0.05|Mixed Models Analysis|||||-12.5|-26.7|<0.01
91584283|NCT03727438|183058862|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-20.6|||<|0.01|TWO_SIDED|95.0|-29.1|-12.0||alpha = .05|Mixed Models Analysis|||||-12.0|-29.1|<0.01
91584284|NCT03727438|183058863|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|11.0|||<|0.01|TWO_SIDED|95.0|7.7|14.3|||Mixed Models Analysis|alpha = 0.05||||14.3|7.7|<0.01
91584285|NCT03727438|183058864|EQUIVALENCE|Alpha = .05|Mean Difference (Final Values)|-6.2|||>|0.05|TWO_SIDED|95.0|-12.5|0.1||Alpha = .05|Mixed Models Analysis|||||0.1|-12.5|> 0.05
91584286|NCT03727438|183058865|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.4|0.5||alpha =.05|Mixed Models Analysis|||||.5|-.4|>0.05
91584287|NCT03727438|183058866|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|1.5|||<|0.05|TWO_SIDED|95.0|0.2|2.9||alpha = .05|Mixed Models Analysis|||||2.9|0.2|<0.05
91584288|NCT06729606|183058867|SUPERIORITY||Odds Ratio (OR)|1.11||||0.54|TWO_SIDED|95.0|0.8|1.55||Proportional odds model stratified by disease severity (high flow nasal canula \[HFNC\]/non-invasive ventilation \[NIV\] or invasive mechanical ventiliation \[IMV\]/ECMO) at study entry to determine the odds of being in a better category at day 90.|Proportional odds model||Summary odds ratio for being in a better category, active/placebo (95% confidence interval); pvalue|||1.55|0.80|0.54
91584289|NCT06729606|183058868|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.78|TWO_SIDED|95.0|0.77|1.41|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.41|0.77|0.78
91584290|NCT06729606|183058869|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1|TWO_SIDED|95.0|0.94|2.08|||Regression, Logistic||Odds ratio for active/placebo (95% confidence interval); pvalue|||2.08|0.94|0.10
91584291|NCT06729606|183058870|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.44|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.44|0.95|0.15
91584292|NCT06729606|183058871|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.71|TWO_SIDED|95.0|0.79|1.42|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.42|0.79|0.71
91584293|NCT02491632|183058875|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
91584294|NCT02491632|183058875|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
91584295|NCT02491632|183058875|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
91584296|NCT02491632|183058875|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
91584297|NCT02491632|183058876|OTHER||||||=|0.003|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.003
91584298|NCT02491632|183058876|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
91584299|NCT02491632|183058876|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
91584300|NCT02491632|183058876|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
91584301|NCT02491632|183058877|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
91584302|NCT02491632|183058877|OTHER||||||<|0.065|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.065
91646854|NCT02058368|183185334|SUPERIORITY|||||||0.91||||||P-value for IPSS improvement \>= 3 units has been presented for Month 3|Mantel Haenszel|||||||0.91
91646855|NCT02058368|183185334|SUPERIORITY|||||||0.31||||||P-value for IPSS improvement \>= 2 units has been presented for Month 3|Mantel Haenszel|||||||0.31
91646856|NCT02058368|183185334|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 3|Mantel Haenszel|||||||0.42
91584303|NCT02491632|183058877|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
91584304|NCT02491632|183058877|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
91584305|NCT02491632|183058878|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
91584306|NCT02491632|183058878|OTHER||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.30
91584307|NCT02491632|183058878|OTHER||||||=|0.19|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.19
91584308|NCT02491632|183058878|OTHER||||||=|0.27|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.27
91584309|NCT00231153|183058886|SUPERIORITY_OR_OTHER||Net percentage difference|2.25||||0.082||95.0|-0.3|4.81||The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.|Cochran-Mantel-Haenszel|||Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.||4.81|-0.30|0.082
91584310|NCT00231153|183058887|SUPERIORITY_OR_OTHER||Net percentage difference|3.67||||0.002||95.0|1.4|5.93|||Cochran-Mantel-Haenszel|||||5.93|1.40|0.002
91584311|NCT00231153|183058888|SUPERIORITY_OR_OTHER||Net percentage difference|11.4|||<|0.001||95.0|6.7|16.11|||Cochran-Mantel-Haenszel|||||16.11|6.70|<0.001
91646857|NCT02058368|183185334|SUPERIORITY|||||||0.92||||||P-value for IPSS improvement \>= 3 units has been presented for Month 6|Mantel Haenszel|||||||0.92
91646858|NCT02058368|183185334|SUPERIORITY|||||||0.89||||||P-value for IPSS improvement \>= 2 units has been presented for Month 6|Mantel Haenszel|||||||0.89
91646859|NCT02058368|183185334|SUPERIORITY|||||||0.81||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 6|Mantel Haenszel|||||||0.81
91646860|NCT02058368|183185334|SUPERIORITY|||||||0.08||||||P-value for IPSS improvement \>= 3 units has been presented for Month 9|Mantel Haenszel|||||||0.080
91584312|NCT00604279|183058900|NON_INFERIORITY_OR_EQUIVALENCE|The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points|Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.48||||95.0|-5.2|0.63|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.63|-5.20|
91584313|NCT00604279|183058901|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.34||||95.0|-2.14|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||3.12|-2.14|
91584314|NCT00604279|183058902|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||||95.0|-0.33|0.1|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.10|-0.33|
91584315|NCT00604279|183058903|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.08||||95.0|-0.67|7.5|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Quality of sleep||7.50|-0.67|
91584316|NCT00604279|183058903|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-5.04|2.9|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Daytime drowsiness||2.90|-5.04|
91584317|NCT00604279|183058904|SUPERIORITY_OR_OTHER||Point estimate of relative risk|0.9||||||95.0|0.81|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.81|
91584318|NCT03938545|183058905|SUPERIORITY||Risk Difference (RD)|21.4|||=|0.1993|TWO_SIDED|95.0|-11.3|54.1||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 680 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||54.1|-11.3|=0.1993
91584319|NCT03938545|183058905|SUPERIORITY||Risk Difference (RD)|24.2|||=|0.1016|TWO_SIDED|95.0|-4.8|53.2||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 340 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||53.2|-4.8|=0.1016
91584320|NCT03938545|183058905|SUPERIORITY||Risk Difference (RD)|-8.3|||=|0.2963|TWO_SIDED|95.0|-24.0|7.3||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 255 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||7.3|-24.0|=0.2963
91584321|NCT03938545|183058907|SUPERIORITY||Least Square Mean Difference|-60.085|||<|0.001|TWO_SIDED|95.0|-88.857|-31.313|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-31.313|-88.857|<0.001
91584322|NCT03938545|183058907|SUPERIORITY||Least Square Mean Difference|-65.143|||<|0.001|TWO_SIDED|95.0|-91.927|-38.358|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-38.358|-91.927|<0.001
91584323|NCT03938545|183058907|SUPERIORITY||Least Square Mean Difference|-37.323|||=|0.0284|TWO_SIDED|95.0|-70.455|-4.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-4.190|-70.455|=0.0284
91584324|NCT03938545|183058908|SUPERIORITY||Least Square Mean Difference|-73.003|||<|0.001|TWO_SIDED|95.0|-82.309|-63.697|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-63.697|-82.309|<0.001
91584325|NCT03938545|183058908|SUPERIORITY||Least Square Mean Difference|-59.005|||<|0.001|TWO_SIDED|95.0|-67.821|-50.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-50.190|-67.821|<0.001
91584326|NCT03938545|183058908|SUPERIORITY||Least Square Mean Difference|-51.836|||<|0.001|TWO_SIDED|95.0|-62.66|-41.012|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-41.012|-62.660|<0.001
91584327|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-81.49|||<|0.001|TWO_SIDED|95.0|-93.203|-69.777|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-69.777|-93.203|<0.001
91584328|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-67.591|||<|0.001|TWO_SIDED|95.0|-78.562|-56.62|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-56.620|-78.562|<0.001
91584329|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-67.233|||<|0.001|TWO_SIDED|95.0|-81.073|-53.394|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-53.394|-81.073|<0.001
91584330|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-74.865|||<|0.001|TWO_SIDED|95.0|-86.898|-62.832|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-62.832|-86.898|<0.001
91584331|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-53.198|||<|0.001|TWO_SIDED|95.0|-64.799|-41.596|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-41.596|-64.799|<0.001
91584332|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-53.398|||<|0.001|TWO_SIDED|95.0|-67.552|-39.245|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-39.245|-67.552|<0.001
91584333|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-88.764|||<|0.001|TWO_SIDED|95.0|-103.039|-74.489|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-74.489|-103.039|<0.001
91584334|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-65.714|||<|0.001|TWO_SIDED|95.0|-78.742|-52.686|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-52.686|-78.742|<0.001
91584335|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-66.685|||<|0.001|TWO_SIDED|95.0|-83.157|-50.214|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-50.214|-83.157|<0.001
91584336|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-68.722|||<|0.001|TWO_SIDED|95.0|-80.877|-56.568|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-56.568|-80.877|<0.001
91584337|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-55.554|||<|0.001|TWO_SIDED|95.0|-67.182|-43.926|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-43.926|-67.182|<0.001
91646861|NCT02058368|183185334|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 9|Mantel Haenszel|||||||0.42
91584338|NCT03938545|183058909|SUPERIORITY||Least Square Mean Difference|-53.079|||<|0.001|TWO_SIDED|95.0|-67.948|-38.21|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-38.210|-67.948|<0.001
91584339|NCT01060540|183058924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.44|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Adjusted for family history (low/unknown vs. high/moderate) and BMI\>=35 (yes vs no) stratification variables||||0.7|-0.3|0.44
91584340|NCT01060540|183058925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.19|TWO_SIDED|95.0|-0.1|0.3||adjusted for baseline BMI class and family history level stratification variables|Mixed Models Analysis|||||0.3|-0.1|0.19
91584341|NCT01060540|183058926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.38|TWO_SIDED|95.0|-0.4|0.1||adjusted for stratification variables baseline BMI and family history|Mixed Models Analysis|||||0.1|-0.4|0.38
91708426|NCT03299101|183309722|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and day of surgery.||||0.410
91584342|NCT01060540|183058927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.05|TWO_SIDED|95.0|-0.2|0.0||adjusted for baseline family history and BMI|Mixed Models Analysis|||||0.0|-0.2|0.05
91584343|NCT01060540|183058928|SUPERIORITY_OR_OTHER||incident rate ratio|0.9||||0.68|TWO_SIDED|95.0|0.7|1.2||adjusted for baseline family history and BMI|generalized linear model for count data|||||1.2|0.7|0.68
91584344|NCT00596427|183058949|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared.||||<0.01
91584345|NCT00596427|183058950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mixed-effects regression models|||Change from baseline between groups was compared.||||<0.001
91584346|NCT00596427|183058951|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|This model had fixed effects of treatment, visit and treatment by visit interaction and a random subject effect.||Comparison of change from baseline between groups (treatment effect)||||<0.1
91584347|NCT00596427|183058952|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||||||<0.01
91646862|NCT02058368|183185334|SUPERIORITY|||||||0.06||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 9|Mantel Haenszel|||||||0.060
91646863|NCT02058368|183185334|SUPERIORITY|||||||0.14||||||P-value for IPSS improvement \>= 3 units has been presented for Month 12|Mantel Haenszel|||||||0.14
91584348|NCT00596427|183058953|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||mixed-effects regression models|||||||<0.05
91584349|NCT00596427|183058954|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared (treatment effect)||||<0.1
91584350|NCT00596427|183058955|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||mixed-effects regression models|||||||0.05
91584351|NCT00596427|183058956|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||mixed-effects regression models|||||||0.6
91584352|NCT00596427|183058957|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||0.3
91584353|NCT00596427|183058958|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.0001
91584354|NCT00596427|183058959|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.01
91584355|NCT00596427|183058960|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||||||<0.1
91584356|NCT02401867|183058961|NON_INFERIORITY_OR_EQUIVALENCE|We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar's test adjusted for analysis of clustered matched-pair data.||||||0.29||||||Statistical significance was determined at an a priori threshold of p \<0.05|McNemar|Degrees of freedom = 1||Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]||||.29
91584357|NCT02401867|183058961|SUPERIORITY_OR_OTHER||Kappa|0.75|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.58|0.92||A priori threshold: p\<0.05|Kappa||Using the asymptotic standard error assuming the null hypothesis.|Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.||0.92|0.58|<0.001
91646864|NCT02058368|183185334|SUPERIORITY|||||||0.26||||||P-value for IPSS improvement \>= 2 units has been presented for Month 12|Mantel Haenszel|||||||0.26
91584358|NCT02401867|183058961|SUPERIORITY_OR_OTHER||Sensitivity|71.43|||||TWO_SIDED|95.0|47.82|88.72|||||Used exact confidence intervals.|Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||88.72|47.82|
91584359|NCT02401867|183058961|NON_INFERIORITY_OR_EQUIVALENCE|Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|Specificity|98.18|||||TWO_SIDED|95.0|93.59|99.78|||||Used exact confidence intervals.|||99.78|93.59|
91584360|NCT02401867|183058961|SUPERIORITY_OR_OTHER||Positive Predictive Value|88.24|||||TWO_SIDED|95.0|63.56|98.54|||||Used exact confidence intervals.|Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.54|63.56|
91778190|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7527|TWO_SIDED|95.0|0.2|3.23|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||3.23|0.20|0.7527
91584361|NCT02401867|183058961|SUPERIORITY_OR_OTHER||Negative predictive value|94.74|||||TWO_SIDED|95.0|88.9|98.04|||||Used exact confidence intervals|Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.04|88.90|
91584362|NCT03435497|183058965|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.017|TWO_SIDED||||||Regression, Linear|||||||.017
91584363|NCT03435497|183058966|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.5||||0.05|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||||1.6|0.2|.05
91584364|NCT03435497|183058967|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
91646865|NCT02058368|183185334|SUPERIORITY|||||||0.048||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 12|Mantel Haenszel|||||||0.048
91646866|NCT02058368|183185334|SUPERIORITY|||||||0.17||||||P-value for IPSS improvement \>= 3 units has been presented for Month 15|Mantel Haenszel|||||||0.17
91646867|NCT02058368|183185334|SUPERIORITY|||||||0.11||||||P-value for IPSS improvement \>= 2 units has been presented for Month 15|Mantel Haenszel|||||||0.11
91646868|NCT02058368|183185334|SUPERIORITY|||||||0.022||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 15|Mantel Haenszel|||||||0.022
91646869|NCT02058368|183185334|SUPERIORITY|||||||0.18||||||P-value for IPSS improvement \>= 3 units has been presented for Month 18|Mantel Haenszel|||||||0.18
91778191|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Emotional functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
91778192|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.3177|TWO_SIDED|95.0|0.62|1.17|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.17|0.62|0.3177
91778193|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4184|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.21|0.63|0.4184
91584365|NCT03435497|183058968|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED||||||Regression, Linear|||||||0.012
91584366|NCT03435497|183058969|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Odds Ratio (OR)|10.0||||0.022|TWO_SIDED|95.0|1.5|67.7|||Regression, Logistic|||||67.7|1.5|0.022
91584367|NCT03719170|183058970|SUPERIORITY||Slope|0.0000684|||||TWO_SIDED|95.0|-0.0003|0.000413||||||"Power Calculation:~Assuming approximately the same number of eligible subjects in each VISN (with an average of 10,563 candidates per VISN) and an Intraclass correlation coefficient (ICC) of 0.12, randomizing 17 VISNs will give more than 80% power to detect % days on PPI of 75% vs. 50%, 85% vs. 60%, 80% vs. 55%, or 70% vs. 45%, but to detect a difference between 70% vs. 50%, power is only 61% using 0.05 level 2-sided test."||0.000413|-0.0003|
91584368|NCT04281004|183058971|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91584369|NCT04281004|183058972|SUPERIORITY|||||||0.869|||||||Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.869
91584370|NCT04281004|183058973|SUPERIORITY|||||||0.007||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.007
91584371|NCT04281004|183058973|SUPERIORITY|||||||0.953||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.953
91584372|NCT04281004|183058973|SUPERIORITY|||||||0.841||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.841
91584373|NCT04281004|183058973|SUPERIORITY|||||||0.137||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.137
91584374|NCT04281004|183058974|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
91584375|NCT04281004|183058975|SUPERIORITY|||||||0.594|||||||Fisher Exact|||||||0.594
91584376|NCT04281004|183058976|SUPERIORITY|||||||0.663||||||Significance of treatment effect at month 1.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.663
91584377|NCT04281004|183058976|SUPERIORITY|||||||0.416||||||Significance of treatment effect at month 3.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.416
91584378|NCT04281004|183058976|SUPERIORITY|||||||0.89||||||Significance of treatment effect at month 6.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.890
91708427|NCT03299101|183309722|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.622|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.||||0.622
91584379|NCT04281004|183058976|SUPERIORITY|||||||0.192||||||Significance of treatment effect at month 12.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.192
91584380|NCT04281004|183058977|SUPERIORITY|||||||0.057||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.057
91584381|NCT04281004|183058977|SUPERIORITY|||||||0.528||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.528
91584382|NCT04281004|183058977|SUPERIORITY|||||||0.21||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.210
91584383|NCT04281004|183058977|SUPERIORITY|||||||0.853||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.853
91584384|NCT02245672|183058987|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
91584385|NCT02245672|183058987|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established.For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
91646870|NCT02058368|183185334|SUPERIORITY|||||||0.19||||||P-value for IPSS improvement \>= 2 units has been presented for Month 18|Mantel Haenszel|||||||0.19
91646871|NCT02058368|183185334|SUPERIORITY|||||||0.28||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 18|Mantel Haenszel|||||||0.28
91584386|NCT02245672|183058988|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.12|||||TWO_SIDED|90.0|1.016|1.237|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for the FEV1 AUEC0-12 clinical endpoint|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.237|1.016|
91584387|NCT02245672|183058989|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
91584388|NCT02245672|183058989|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
91584389|NCT02245672|183058990|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.069|||||TWO_SIDED|90.0|0.938|1.22|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for change from baseline in trough FEV1 endpoint on Day 29|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.220|0.938|
91584390|NCT04363801|183058997|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.9676|TWO_SIDED|95.0|0.98|2.05|||Log Rank|||||2.05|0.98|0.9676
91584391|NCT04363801|183059014|SUPERIORITY||Risk Difference (RD)|2.4||||0.3799|TWO_SIDED|95.0|-12.2|16.9|||Cochran-Mantel-Haenszel|||||16.9|-12.2|0.3799
91584392|NCT04363801|183059017|SUPERIORITY|||||||0.8679|||||||Log Rank|Stratified Log-rank Test||||||0.8679
91584393|NCT04363801|183059017|SUPERIORITY|||||||0.9676|||||||Log Rank|Stratified Log-rank Test||||||0.9676
91584394|NCT04363801|183059017|SUPERIORITY||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.74|3.05||||||||3.05|0.74|
91584395|NCT04363801|183059017|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.98|2.05||||||||2.05|0.98|
91584396|NCT04363801|183059018|SUPERIORITY||Risk Difference (RD)|8.4||||0.2649|TWO_SIDED|95.0|-18.4|33.6|||Mantel Haenszel||Common Risk Difference and 95% CI: estimated by stratified Newcombe method, weighted by minimum risk|||33.6|-18.4|0.2649
91584397|NCT04363801|183059018|SUPERIORITY||Risk Difference (RD)|2.4||||0.379|TWO_SIDED|95.0|-12.2|16.9|||Mantel Haenszel|||||16.9|-12.2|0.379
91584398|NCT02901041|183059027|SUPERIORITY||Mean Difference (Net)|0.02||||0.98|TWO_SIDED|95.0|-1.41|1.45|||t-test, 2 sided|t=0.03, df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||1.45|-1.41|.98
91584399|NCT02901041|183059028|SUPERIORITY||Mean Difference (Net)|-0.83||||0.13|TWO_SIDED|95.0|-1.92|0.26|||t-test, 2 sided|t=-1.52, df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.26|-1.92|.13
91584400|NCT02901041|183059029|SUPERIORITY||Mean Difference (Net)|-0.07||||0.19|TWO_SIDED|95.0|-0.17|0.03||Equality of variance was not assumed.|t-test, 2 sided|t=-1.33, df=72.65||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.03|-0.17|.19
91584401|NCT02901041|183059030|SUPERIORITY||Mean Difference (Net)|-0.17||||0.05|TWO_SIDED|95.0|-0.34|0.0|||t-test, 2 sided|t=-1.99, df=56.00||||0.00|-0.34|.05
91584402|NCT02901041|183059031|SUPERIORITY||Mean Difference (Net)|0.03||||0.71|TWO_SIDED|95.0|-0.11|0.17|||t-test, 2 sided|t=0.37,df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.17|-0.11|.71
91584403|NCT02901041|183059032|SUPERIORITY||Mean Difference (Net)|-0.11||||0.12|TWO_SIDED|95.0|-0.26|0.03|||t-test, 2 sided|t=-1.59,df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.26|.12
91584404|NCT02901041|183059033|SUPERIORITY||Mean Difference (Net)|0.14||||0.98|TWO_SIDED|95.0|-9.89|10.18|||t-test, 2 sided|t=0.03, df=79.00||||10.18|-9.89|.98
91584405|NCT02901041|183059034|SUPERIORITY||Mean Difference (Net)|-5.8||||0.13|TWO_SIDED|95.0|-13.43|1.83|||t-test, 2 sided|t=-1.52, df=56.00||||1.83|-13.43|.13
91584406|NCT02901041|183059035|SUPERIORITY||Mean Difference (Net)|27.07||||0.75|TWO_SIDED|95.0|-144.06|198.2|||t-test, 2 sided|t=0.32,df=61.00||||198.20|-144.06|.75
91646872|NCT02058368|183185334|SUPERIORITY|||||||0.39||||||P-value for IPSS improvement \>= 3 units has been presented for Month 21|Mantel Haenszel|||||||0.39
91646873|NCT02058368|183185334|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 21|Mantel Haenszel|||||||0.42
91646874|NCT02058368|183185334|SUPERIORITY|||||||0.084||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 21|Mantel Haenszel|||||||0.084
91646875|NCT02058368|183185334|SUPERIORITY|||||||0.016||||||P-value for IPSS improvement \>= 3 units has been presented for Month 24|Mantel Haenszel|||||||0.016
91646876|NCT02058368|183185334|SUPERIORITY|||||||0.047||||||P-value for IPSS improvement \>= 2 units has been presented for Month 24|Mantel Haenszel|||||||0.047
91646877|NCT02058368|183185334|SUPERIORITY|||||||0.007||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 24|Mantel Haenszel|||||||0.007
91646878|NCT02058368|183185335|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.33||0.006|TWO_SIDED|95.0|0.26|1.56||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.56|0.26|0.006
91646879|NCT02058368|183185335|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.005|TWO_SIDED|95.0|0.3|1.69||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.69|0.30|0.005
91646880|NCT02058368|183185335|SUPERIORITY||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|0.63|2.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.29|0.63|<.001
91646881|NCT02058368|183185335|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|0.54|2.15||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.15|0.54|0.001
91646882|NCT02058368|183185336|SUPERIORITY|||||||0.13||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 6|Mantel Haenszel|||||||0.13
91646883|NCT02058368|183185336|SUPERIORITY|||||||0.15||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 6|Mantel Haenszel|||||||0.15
91646884|NCT02058368|183185336|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 12|Mantel Haenszel|||||||<.001
91646885|NCT02058368|183185336|SUPERIORITY|||||||0.003||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 12|Mantel Haenszel|||||||0.003
91778194|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.571|TWO_SIDED|95.0|0.67|1.24|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.24|0.67|0.5710
91778195|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3973|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.19|0.65|0.3973
91778196|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.5163|TWO_SIDED|95.0|0.8|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.55|0.80|0.5163
91646886|NCT02058368|183185336|SUPERIORITY|||||||0.002||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 18|Mantel Haenszel|||||||0.002
91646887|NCT02058368|183185336|SUPERIORITY|||||||0.009||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 18|Mantel Haenszel|||||||0.009
91708428|NCT03299101|183309722|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.757|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.||||0.757
91646888|NCT02058368|183185336|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 24|Mantel Haenszel|||||||<.001
91646889|NCT02058368|183185336|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 24|Mantel Haenszel|||||||<.001
91646890|NCT02058368|183185337|SUPERIORITY||Cox Proportional Hazard|0.27||||0.012|TWO_SIDED|95.0|0.09|0.81||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.81|0.09|0.012
91646891|NCT02058368|183185338|SUPERIORITY||Cox Proportional Hazard|0.15||||0.005|TWO_SIDED|95.0|0.03|0.68||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.68|0.03|0.005
91646892|NCT02058368|183185339|SUPERIORITY||Cox Proportional Hazard|0.69||||0.68|TWO_SIDED|95.0|0.11|4.11||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||4.11|0.11|0.68
91646893|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.83|TWO_SIDED|95.0|-0.17|0.21||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.21|-0.17|0.83
91708429|NCT03299101|183309723|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.||||0.362
91778197|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6897|TWO_SIDED|95.0|0.64|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.35|0.64|0.6897
91778198|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.5735|TWO_SIDED|95.0|0.67|1.25|||Cochran-Mantel-Haenszel|||Physical functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.67|0.5735
91778199|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.75||||0.1414|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.10|0.50|0.1414
91778200|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8655|TWO_SIDED|95.0|0.59|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.55|0.59|0.8655
91584407|NCT02901041|183059036|SUPERIORITY||Mean Difference (Net)|99.05||||0.35|TWO_SIDED|95.0|-111.11|309.21|||t-test, 2 sided|t=0.95, df=46.00||||309.21|-111.11|.35
91584408|NCT02901041|183059037|SUPERIORITY||Mean Difference (Net)|0.85||||0.51|TWO_SIDED|95.0|-1.69|3.4|||t-test, 2 sided|t=0.67, df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||3.40|-1.69|.51
91584409|NCT02901041|183059038|SUPERIORITY||Mean Difference (Net)|-0.42||||0.55|TWO_SIDED|95.0|-1.82|0.98|||t-test, 2 sided|t=-0.61,df=36||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.98|-1.82|.55
91584410|NCT02901041|183059039|SUPERIORITY||Mean Difference (Net)|0.15||||0.95|TWO_SIDED|95.0|-4.15|4.45|||t-test, 2 sided|t=0.07,df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||4.45|-4.15|.95
91584411|NCT02901041|183059040|SUPERIORITY||Mean Difference (Net)|3.34||||0.42|TWO_SIDED|95.0|-4.93|11.62|||t-test, 2 sided|t=0.82, df=38.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||11.62|-4.93|.42
91584412|NCT02901041|183059041|SUPERIORITY||Mean Difference (Net)|0.32||||0.17|TWO_SIDED|95.0|-0.15|0.8||Equal variance was not assumed.|t-test, 2 sided|t=1.39, df=36.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.80|-0.15|.17
91584413|NCT02901041|183059042|SUPERIORITY||Mean Difference (Net)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.97||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.53, df=24.05||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.97|-0.14|0.14
91778201|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.3017|TWO_SIDED|95.0|0.38|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.35|0.38|0.3017
91778202|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.2325|TWO_SIDED|95.0|0.26|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||1.39|0.26|0.2325
91584414|NCT02901041|183059043|SUPERIORITY||Mean Difference (Net)|3.07||||0.14|TWO_SIDED|95.0|-1.03|7.16||Equal variances were not assumed when conducting the t-tests.|t-test, 2 sided|t=1.51,df=39.34||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||7.16|-1.03|.14
91778203|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.33||||0.1717|TWO_SIDED|95.0|0.06|1.69|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||1.69|0.06|0.1717
91778204|NCT03038100|183438014|SUPERIORITY|Stratified Analsyis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Physical functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
91778205|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4745|TWO_SIDED|95.0|0.84|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.46|0.84|0.4745
91584415|NCT02901041|183059044|SUPERIORITY||Mean Difference (Net)|3.18||||0.4|TWO_SIDED|95.0|-4.39|10.75||Equality of variance was not assumed.|t-test, 2 sided|t=0.85, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||10.75|-4.39|.40
91778206|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5499|TWO_SIDED|95.0|0.69|1.22|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.22|0.69|0.5499
91584416|NCT02901041|183059045|SUPERIORITY||Mean Difference (Net)|0.4||||0.06|TWO_SIDED|95.0|-0.01|0.81||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.97, df=38.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.81|-0.01|.06
91584417|NCT02901041|183059046|SUPERIORITY||Mean Difference (Net)|0.03||||0.96|TWO_SIDED|95.0|-1.0|1.05|||t-test, 2 sided|t=.06, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||1.05|-1.00|.96
91778207|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8436|TWO_SIDED|95.0|0.73|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.29|0.73|0.8436
91778208|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5798|TWO_SIDED|95.0|0.81|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.46|0.81|0.5798
91778209|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9094|TWO_SIDED|95.0|0.74|1.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.39|0.74|0.9094
91778210|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.4006|TWO_SIDED|95.0|0.81|1.67|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||1.67|0.81|0.4006
91778211|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4024|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.19|0.65|0.4024
91778212|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8796|TWO_SIDED|95.0|0.67|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.41|0.67|0.8796
91778213|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.435|TWO_SIDED|95.0|0.53|1.32|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.32|0.53|0.4350
91778214|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.6225|TWO_SIDED|95.0|0.47|1.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||1.56|0.47|0.6225
91778215|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.5775|TWO_SIDED|95.0|0.36|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||1.77|0.36|0.5775
91778216|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.37||||0.2343|TWO_SIDED|95.0|0.07|1.94|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||1.94|0.07|0.2343
91778217|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-66.67||||0.0833|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.0833
91584418|NCT02901041|183059047|SUPERIORITY||Mean Difference (Net)|2.03||||0.6|TWO_SIDED|95.0|-5.58|9.64|||t-test, 2 sided|t=0.53,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||9.64|-5.58|.60
91584419|NCT02901041|183059048|SUPERIORITY||Mean Difference (Net)|-0.06||||0.21|TWO_SIDED|95.0|-0.15|0.03|||t-test, 2 sided|t=-1.27, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.15|.21
91584420|NCT02901041|183059049|SUPERIORITY||Mean Difference (Net)|-0.28||||0.09|TWO_SIDED|95.0|-0.6|0.04|||t-test, 2 sided|t=-1.74,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.04|-0.60|.09
91778218|NCT03038100|183438014|SUPERIORITY|Superiority|Odds Ratio (OR)|0.93||||0.6012|TWO_SIDED|95.0|0.71|1.21|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.21|0.71|0.6012
91778219|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.2291|TWO_SIDED|95.0|0.65|1.11|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.11|0.65|0.2291
91778220|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6574|TWO_SIDED|95.0|0.71|1.24|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.24|0.71|0.6574
91584421|NCT02901041|183059050|SUPERIORITY||Mean Difference (Net)|-0.35||||0.1|TWO_SIDED|95.0|-0.78|0.07|||t-test, 2 sided|t=-1.69, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.07|-0.78|.10
91584422|NCT02901041|183059051|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.15|0.19|||t-test, 2 sided|t=0.25,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.19|-0.15|0.80
91584423|NCT02901041|183059052|SUPERIORITY||Mean Difference (Net)|-5.61||||0.41|TWO_SIDED|95.0|-14.56|3.34|||t-test, 2 sided|t=-0.84,df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||3.34|-14.56|.41
91778221|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9217|TWO_SIDED|95.0|0.76|1.35|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.35|0.76|0.9217
91778222|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7693|TWO_SIDED|95.0|0.7|1.3|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.30|0.70|0.7693
91778223|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.647|TWO_SIDED|95.0|0.64|1.31|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.31|0.64|0.6470
91778224|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6391|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Role functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.70|0.6391
91778225|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.0892|TWO_SIDED|95.0|0.51|1.05|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.05|0.51|0.0892
91584424|NCT03818204|183059062|OTHER||||||>=|0.46|||||||Regression, Linear|||The effect of angular position was modeled using linear mixed-effects (multiple regression) models. The five angles were randomly mapped for the dependent variable interpalpebral fissure. Because there were repeated measurements on each eye and each participant might respond differently to each angular position, participant and angular position within participant-eye were included as random effects.||||>=0.46
91646894|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|-0.04|0.36||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.36|-0.04|0.11
91646895|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.21|TWO_SIDED|95.0|-0.07|0.34||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.34|-0.07|0.21
91646896|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.23|0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.18|-0.23|0.80
91646897|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.3|0.11||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.11|-0.30|0.37
91708430|NCT03299101|183309723|SUPERIORITY||Mean Difference (Net)|25.52|STANDARD_ERROR_OF_MEAN|20.06||0.203|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.||||.203
91708431|NCT03299101|183309723|SUPERIORITY||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|13.77||0.357|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.||||0.357
91584425|NCT05754333|183059069|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.2|1.9|||paired t Test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||1.9|1.2|<0.001
91584426|NCT05754333|183059070|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.2|1.8|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.|||1.8|1.2|<0.001
91584427|NCT05754333|183059071|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.0|1.7|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||1.7|1.0|<0.001
91584428|NCT05754333|183059073|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||||
91584429|NCT05754333|183059074|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|||||
91584430|NCT05754333|183059075|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||||
91584431|NCT05754333|183059076|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||||
91584432|NCT05754333|183059077|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|||||
91584433|NCT05754333|183059078|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.6|||||||||||Mean Difference is calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||||
91584434|NCT05754333|183059079|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||||
91584435|NCT05754333|183059080|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|||||
91646898|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11||0.44|TWO_SIDED|95.0|-0.3|0.13||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.13|-0.30|0.44
91708432|NCT03299101|183309723|SUPERIORITY||Mean Difference (Net)|21.48|STANDARD_ERROR_OF_MEAN|15.4||0.163|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.||||0.163
91708433|NCT03299101|183309724|SUPERIORITY|||||||0.068|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across all 4 time points.||||0.068
91778226|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.055|TWO_SIDED|95.0|0.41|1.01|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.01|0.41|0.0550
91584436|NCT05754333|183059081|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||||
91584437|NCT05754333|183059082|SUPERIORITY||POP with at least 1 Point Higher|67.01|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 1 point higher. POP meeting this criterion was estimated.|||||
91584438|NCT05754333|183059082|SUPERIORITY||POP with at least 2 point higher|40.4|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 2 points higher. POP meeting this criterion was estimated.|||||
91584439|NCT05754333|183059082|SUPERIORITY||POP with at least 3 point higher|20.2|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 3 points higher. POP meeting this criterion was estimated.|||||
91584440|NCT05754333|183059082|SUPERIORITY||POP with at least 4 point higher|2.1|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 4 points higher. POP meeting this criterion was estimated|||||
91584441|NCT05754333|183059083|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.6|2.2|||paired t test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||2.2|1.6|<0.001
91584442|NCT05754333|183059083|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.221|||||TWO_SIDED|95.0|-0.011|0.431||||||CCC between BICR and investigator (95% CI), Reader 2||0.431|-0.011|
91584443|NCT05754333|183059083|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.8|1.5|||paired t test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||1.5|0.8|<0.001
91708434|NCT03299101|183309724|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.043|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and day of surgery.||||0.043
91708435|NCT03299101|183309724|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.092|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and 90 days postop.||||0.092
91778227|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.49||||0.0168|TWO_SIDED|95.0|0.27|0.88|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||0.88|0.27|0.0168
91778228|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.29||||0.0021|TWO_SIDED|95.0|0.13|0.65|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||0.65|0.13|0.0021
91778229|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7817|TWO_SIDED|95.0|0.17|3.8|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||3.80|0.17|0.7817
91778230|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Role functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
91778231|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.6646|TWO_SIDED|95.0|0.8|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.41|0.80|0.6646
91778232|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8677|TWO_SIDED|95.0|0.73|1.3|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.30|0.73|0.8677
91778233|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.767|TWO_SIDED|95.0|0.79|1.38|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.38|0.79|0.7670
91778234|NCT03038100|183438014|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7487|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.28|0.71|0.7487
91778235|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.1882|TWO_SIDED|95.0|0.9|1.68|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.68|0.90|0.1882
91778236|NCT03038100|183438014|SUPERIORITY||Odds Ratio (OR)|1.21||||0.3015|TWO_SIDED|95.0|0.84|1.72|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.72|0.84|0.3015
91778237|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.9059|TWO_SIDED|95.0|0.73|1.32|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.32|0.73|0.9059
91778238|NCT03038100|183438014|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7125|TWO_SIDED|95.0|0.65|1.35|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.35|0.65|0.7125
91778239|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.68||||0.0947|TWO_SIDED|95.0|0.43|1.07|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.07|0.43|0.0947
91778240|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.58||||0.0686|TWO_SIDED|95.0|0.32|1.05|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||1.05|0.32|0.0686
91778241|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.39||||0.0175|TWO_SIDED|95.0|0.17|0.86|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||0.86|0.17|0.0175
91778242|NCT03038100|183438014|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.46||||0.3376|TWO_SIDED|95.0|0.09|2.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||2.30|0.09|0.3376
91778243|NCT03038100|183438014|SUPERIORITY||Difference in Proportion of Responders|-50.0||||0.5637|TWO_SIDED|95.0|-100.0|23.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 24 Months||23.34|-100.00|0.5637
91646899|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.6|TWO_SIDED|95.0|-0.16|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.28|-0.16|0.60
91646900|NCT02058368|183185340|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.16|TWO_SIDED|95.0|-0.37|0.06||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.06|-0.37|0.16
91646901|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.18||0.17|TWO_SIDED|95.0|-0.11|0.62||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 3|||0.62|-0.11|0.17
91646902|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.59||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 6|||0.59|-0.20|0.33
91646903|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.2||0.15|TWO_SIDED|95.0|-0.1|0.68||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 9|||0.68|-0.10|0.15
91646904|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.21||0.46|TWO_SIDED|95.0|-0.25|0.55||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 12|||0.55|-0.25|0.46
91778244|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.977|TWO_SIDED|95.0|0.76|1.3|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 3 Day 1||1.30|0.76|0.9770
91584444|NCT05754333|183059083|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.053|||||TWO_SIDED|95.0|-0.181|0.282||||||CCC between BICR and investigator (95% CI), Reader 3||0.282|-0.181|
91584445|NCT05754333|183059083|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.9|2.6|||paired t test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||2.6|1.9|<0.001
91646905|NCT02058368|183185341|SUPERIORITY||Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.59|TWO_SIDED|95.0|-0.51|0.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 15|||0.29|-0.51|0.59
91646906|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.56|TWO_SIDED|95.0|-0.52|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 18|||0.28|-0.52|0.56
91646907|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.51|TWO_SIDED|95.0|-0.56|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 21|||0.28|-0.56|0.51
91646908|NCT02058368|183185341|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.034|TWO_SIDED|95.0|-0.88|-0.03||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 24|||-0.03|-0.88|0.034
91584446|NCT05754333|183059083|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.26|||||TWO_SIDED|95.0|0.03|0.464||||||CCC between BICR and investigator (95% CI), Reader 4||0.464|0.030|
91584447|NCT05754333|183059084|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|1.4|2.0|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.|For reader 2||2.0|1.4|<0.001
91584448|NCT05754333|183059084|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.219|||||TWO_SIDED|95.0|-0.013|0.429||||||CCC between BICR and investigator (95% CI), Reader 2||0.429|-0.013|
91778245|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7317|TWO_SIDED|95.0|0.8|1.37|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 5 Day 1||1.37|0.80|0.7317
91778246|NCT03038100|183438015|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6937|TWO_SIDED|95.0|0.8|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 8 Day 1||1.39|0.80|0.6937
91778247|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3916|TWO_SIDED|95.0|0.66|1.18|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.18|0.66|0.3916
91708436|NCT03299101|183309724|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.292|TWO_SIDED||||||Mixed Models Analysis|The null hypothesis was rejected a priori if p\<.05.|The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.292
91708437|NCT03299101|183309725|SUPERIORITY|||||||0.625|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across both time points.||||0.625
91708438|NCT01424241|183309739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|300.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||None available.||||<0.05
91708439|NCT01424241|183309739|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<.05
91708440|NCT00519584|183309743|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.39|||Log Rank||Ropivacaine/dex vs. Ropivacaine/saline|||0.39|0.08|<0.001
91708441|NCT00519584|183309743|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.23|0.83|||Log Rank||bupivacaine/dex vs. bupivacaine/Saline|||0.83|0.23|<0.001
91708442|NCT00519584|183309744|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91708443|NCT00519584|183309744|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91708444|NCT00519584|183309745|SUPERIORITY||||||<|0.001||||||adjusted significance level is 0.025|Wilcoxon (Mann-Whitney)|||||||<0.001
91708445|NCT00519584|183309745|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91708446|NCT00519584|183309746|SUPERIORITY|||||||0.29||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.29
91708447|NCT00519584|183309746|SUPERIORITY|||||||0.15||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.15
91708448|NCT05259917|183309747|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||<0.0001
91708449|NCT05259917|183309747|SUPERIORITY|||||||0.0013|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0013
91708450|NCT05259917|183309748|SUPERIORITY|||||||0.0036|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0036
91708451|NCT05259917|183309748|SUPERIORITY|||||||0.0032|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0032
91708452|NCT05259917|183309749|SUPERIORITY|||||||0.0022|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0022
91708453|NCT05259917|183309749|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||<0.0001
91708454|NCT03585712|183309780|OTHER|Is the overall mean change from baseline different from zero? Or did the infringement of schedule regardless the type of infringement lead to a change in mucus score?||||||0.26||||||P value from model testing intercept (does infringement change mucus score?) P-value from a repeated measures mixed model with the period, intervention, sequence and time (visit) as covariates. P-values ≤0.050 are considered significant|Mixed Models Analysis|||"Mixed model for repeated measures using as response delta to Day41, delta to Day42, delta to Day70 and delta to Day71.~Covariates: period, intervention (missed pill or delayed pill), sequence of intervention (missed pill then delayed pill and vice versa), time and subject.~Subject as random effect + time repeated effect within each combination subject\* period"||||0.26
91708455|NCT03585712|183309781|OTHER||||||>|0.999||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Absence of risk increase||||>0.999
91708456|NCT03585712|183309781|OTHER|||||||0.655||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Transient risk increase||||0.655
91708457|NCT03585712|183309781|OTHER|||||||0.317||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Prolonged risk increase||||0.317
91708458|NCT03585712|183309782|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
91708459|NCT03585712|183309782|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period.||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
91708460|NCT03585712|183309783|OTHER|||||||0.127|||||||McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.127
91778248|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.3363|TWO_SIDED|95.0|0.63|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.17|0.63|0.3363
91778249|NCT03038100|183438015|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6761|TWO_SIDED|95.0|0.75|1.55|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.55|0.75|0.6761
91778250|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6997|TWO_SIDED|95.0|0.71|1.26|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/ Early Termination Visit||1.26|0.71|0.6997
91778251|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.3592|TWO_SIDED|95.0|0.82|1.72|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.72|0.82|0.3592
91778252|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8798|TWO_SIDED|95.0|0.62|1.51|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||1.51|0.62|0.8798
91778253|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.3857|TWO_SIDED|95.0|0.43|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.39|0.43|0.3857
91584449|NCT05754333|183059084|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.8|1.4|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter(left or right) for eachparticipant.|For reader 3||1.4|0.8|<0.001
91584450|NCT05754333|183059084|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.043|||||TWO_SIDED|95.0|-0.191|0.272||||||CCC between BICR and investigator (95% CI), Reader 3||0.272|-0.191|
91584451|NCT05754333|183059084|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.8|2.5|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter(left or right) for eachparticipant.|For reader 4||2.5|1.8|<0.001
91584452|NCT05754333|183059084|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.245|||||TWO_SIDED|95.0|0.014|0.451||||||CCC between BICR and investigator (95% CI), Reader 4||0.451|0.014|
91584453|NCT05754333|183059085|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.1|1.8|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||1.8|1.1|<0.001
91584454|NCT05754333|183059085|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.339|||||TWO_SIDED|95.0|0.116|0.529||||||CCC between BICR and investigator (95% CI), Reader 2||0.529|0.116|
91584455|NCT05754333|183059085|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.6|1.3|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||1.3|0.6|<0.001
91584456|NCT05754333|183059085|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.186|||||TWO_SIDED|95.0|-0.048|0.4||||||CCC between BICR and investigator (95% CI), Reader 3||0.400|-0.048|
91646909|NCT02058368|183185342|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.54|-0.5||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.50|-1.54|<.001
91778254|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.6854|TWO_SIDED|95.0|0.39|1.85|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||1.85|0.39|0.6854
91778255|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.54||||0.4533|TWO_SIDED|95.0|0.11|2.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||2.70|0.11|0.4533
91778256|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33||||0.3173|TWO_SIDED|95.0|-100.0|75.44|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|0.3173
91778257|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.13||||0.3658|TWO_SIDED|95.0|0.87|1.47|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.47|0.87|0.3658
91584457|NCT05754333|183059085|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.6|2.3|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||2.3|1.6|<0.001
91778258|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7619|TWO_SIDED|95.0|0.8|1.36|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.36|0.80|0.7619
91584458|NCT05754333|183059085|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.297|||||TWO_SIDED|95.0|0.07|0.495||||||CCC between BICR and investigator (95% CI), Reader 4||0.495|0.070|
91584459|NCT05754333|183059086|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||||
91584460|NCT05754333|183059086|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||||
91584461|NCT05754333|183059086|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||||
91778259|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.658|TWO_SIDED|95.0|0.81|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.81|0.6580
91778260|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.18||||0.2726|TWO_SIDED|95.0|0.88|1.57|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.57|0.88|0.2726
91778261|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6973|TWO_SIDED|95.0|0.69|1.29|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.29|0.69|0.6973
91778262|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.447|TWO_SIDED|95.0|0.8|1.64|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.64|0.80|0.4470
91778263|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.515|TWO_SIDED|95.0|0.68|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.21|0.68|0.5150
91778264|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2103|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.82|0.88|0.2103
91778265|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.7969|TWO_SIDED|95.0|0.68|1.66|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.66|0.68|0.7969
91778266|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.6|1.91|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.91|0.60|0.8300
91584462|NCT05754333|183059087|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|Difference from WL in Means, Reader 2||||
91584463|NCT05754333|183059087|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|Difference from WL in Means, Reader 3||||
91584464|NCT05754333|183059087|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|Difference from WL in Means, Reader 4||||
91584465|NCT05754333|183059088|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||||
91584466|NCT05754333|183059088|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||||
91584467|NCT05754333|183059088|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||||
91584468|NCT05754333|183059089|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||||
91584469|NCT05754333|183059089|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||||
91584470|NCT05754333|183059089|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.5|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||||
91584471|NCT05754333|183059090|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-m in WL score of the ureter of interest (left; right) for each participant.|For reader 2||||
91708461|NCT03585712|183309783|OTHER|||||||0.018||||||\* Indicates significance at the 0.05 level (p-value ≤ 0.05).|McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period.||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.018
91778267|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6987|TWO_SIDED|95.0|0.53|2.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||2.55|0.53|0.6987
91778268|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.32||||0.1441|TWO_SIDED|95.0|0.62|17.77|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||17.77|0.62|0.1441
91584472|NCT05754333|183059090|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 3||||
91584473|NCT05754333|183059090|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 4||||
91708462|NCT03517449|183309786|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.47|0.66|||Log Rank||Regression, Cox method|||0.66|0.47|<0.0001
91584474|NCT05754333|183059091|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||||
91584475|NCT05754333|183059091|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||||
91584476|NCT05754333|183059091|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||||
91584477|NCT05754333|183059092|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||||
91584478|NCT05754333|183059092|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||||
91584479|NCT05754333|183059092|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||||
91708463|NCT03517449|183309787|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Log Rank||Regression, Cox method|||0.75|0.51|<0.0001
91778269|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Difference in proportion of Responders|-66.67||||0.3173|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.3173
91778270|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7591|TWO_SIDED|95.0|0.74|1.25|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 3 Day 1||1.25|0.74|0.7591
91584480|NCT05754333|183059093|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 2||||
91584481|NCT05754333|183059093|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 3||||
91708464|NCT03517449|183309788|SUPERIORITY||Difference in Percent|17.2|||<|0.0001|TWO_SIDED|95.0|11.5|22.9|||Miettinen & Nurminen method|||||22.9|11.5|<0.0001
91584482|NCT05754333|183059093|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 4||||
91584483|NCT05754333|183059094|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||||
91584484|NCT05754333|183059094|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||||
91584485|NCT05754333|183059094|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||||
91708465|NCT00856843|183309803|SUPERIORITY_OR_OTHER||Difference in success rates|8.8||||0.038|TWO_SIDED|95.0|0.9|16.8|||Chi-squared|||||16.8|0.9|0.038
91708466|NCT00856843|183309804|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
91708467|NCT00856843|183309805|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.020
91778271|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5403|TWO_SIDED|95.0|0.83|1.42|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 5 Day 1||1.42|0.83|0.5403
91584486|NCT00440999|183059101|NON_INFERIORITY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the crude cure rate on Day 14 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 10% non-inferiority margin. Non-inferiority was claimed if the lower limit of the 2-sided 95% CI for the difference in cure rates on Day 14 was \>10%.|Difference in cure rate|-0.5|||||TWO_SIDED|95.0|-2.6|1.4|||||Conclusion: non-inferiority between PA \& chloroquine.|"Null hypothesis: The cure rate on Day 14 for the PA group is inferior to the cure rate on Day 14 for the chloroquine group by more than 10%.~Was tested against the alternative:~Alternative hypothesis: The cure rate on Day 14 for the PA group was not inferior to the cure rate on Day 14 for the chloroquine group by more than 10%."||1.4|-2.6|
91584487|NCT03401229|183059110|SUPERIORITY||Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.852|-0.289||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.289|-0.852|<0.0001
91584488|NCT03401229|183059111|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0048|TWO_SIDED|95.0|-0.458|-0.083||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.083|-0.458|0.0048
91708468|NCT00856843|183309806|SUPERIORITY_OR_OTHER|||||||0.644|||||||Chi-squared|||||||0.644
91708469|NCT00856843|183309807|SUPERIORITY_OR_OTHER|||||||0.763|||||||Chi-squared|||||||0.763
91613264|NCT03478878|183120990|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.405|TWO_SIDED|95.0|-19.3|23.9||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||23.90|-19.30|0.405
91613265|NCT04688346|183121023|NON_INFERIORITY|t-test|Mean Difference (Final Values)|1.0||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91613266|NCT00059215|183121025|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||||||0.933
91613267|NCT00059215|183121025|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Log Rank|||||||0.590
91708470|NCT00856843|183309808|SUPERIORITY_OR_OTHER|||||||0.173|||||||Chi-squared|||||||0.173
91708471|NCT00856843|183309809|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
91708472|NCT00856843|183309810|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91778272|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.2654|TWO_SIDED|95.0|0.89|1.55|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 8 Day 1||1.55|0.89|0.2654
91613268|NCT00059215|183121026|SUPERIORITY_OR_OTHER|||||||0.945||95.0|||||Fisher Exact|||||||0.945
91613269|NCT00059215|183121026|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Log Rank|||||||0.260
91613270|NCT00059215|183121027|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91613271|NCT00059215|183121027|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Log Rank|||||||0.544
91613272|NCT00059215|183121028|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Fisher Exact|||||||0.370
91613273|NCT04494633|183121029|SUPERIORITY|||||||0.482314|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t-test with 61 degrees of freedom.||||||0.482314
91613274|NCT04494633|183121030|SUPERIORITY|||||||0.876964|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t test with 61 degrees of freedom.||||||.876964
91613275|NCT04494633|183121031|SUPERIORITY|||||||0.66602|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, with 61 degrees of freedom.||||||.66602
91613276|NCT04494633|183121032|SUPERIORITY|||||||0.726421|||||||t-test, 2 sided|Two-tailed unpaired t test comparing change for control (Pre to 2 weeks later) to case (Pre- to 2 weeks post) with 61 degrees of freedom.||||||.726421
91584489|NCT03401229|183059112|SUPERIORITY||Mean Difference (Net)|-5.212||||0.0821|TWO_SIDED|95.0|-11.087|0.664||Since both primary endpoints were significant at significant level of 0.01 level, this endpoint was tested at significant level of 0.05.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||0.664|-11.087|0.0821
91584490|NCT03401229|183059113|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.066|TWO_SIDED|95.0|0.55|1.02||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal because test for change from baseline in SNOT-22 at week 40 was not statistically significant.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the rate of incidence of first NP surgery and/or SCS use for NP between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.02|0.55|0.0660
91584491|NCT03401229|183059114|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5008|TWO_SIDED|95.0|0.53|1.36||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of first NP surgery between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.36|0.53|0.5008
91584492|NCT03401229|183059115|SUPERIORITY||Mean Difference (Net)|-0.218||||0.0029|TWO_SIDED|95.0|-0.361|-0.074||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.074|-0.361|0.0029
91584493|NCT03401229|183059116|SUPERIORITY||Mean Difference (Net)|-0.475||||0.0054|TWO_SIDED|95.0|-0.81|-0.141||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NPS is similar between benralizumab and placebo. H1: The change from baseline in NPS is different between benralizumab and placebo.||-0.141|-0.810|0.0054
91613277|NCT04494633|183121033|SUPERIORITY|||||||0.908468|||||||t-test, 2 sided|The statistical test used was a 2 tailed, unpaired t test with 61 degrees of freedom.||||||0.908468
91613278|NCT04494633|183121034|SUPERIORITY|||||||0.468104|||||||t-test, 2 sided|The groups were compared using a two tailed unpaired t test with 61 degrees of freedom.||||||.468104
91613911|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.26|1.726|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.726|1.260|<0.0001
91778273|NCT03038100|183438015|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5138|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 12 Day 1||1.48|0.82|0.5138
91778274|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.22||||0.2138|TWO_SIDED|95.0|0.89|1.67|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 16 Day 1||1.67|0.89|0.2138
91778275|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2114|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 20 Day 1||1.82|0.88|0.2114
91778276|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.3938|TWO_SIDED|95.0|0.85|1.53|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Completion of Treatment/ Early Termination Visit||1.53|0.85|0.3938
91778277|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7793|TWO_SIDED|95.0|0.65|1.38|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 3 Months||1.38|0.65|0.7793
91778278|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.737|TWO_SIDED|95.0|0.69|1.39|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 6 Months||1.39|0.69|0.7370
91778279|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9658|TWO_SIDED|95.0|0.55|1.79|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 9 Months||1.79|0.55|0.9658
91778280|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.3015|TWO_SIDED|95.0|0.29|1.46|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 12 Months||1.46|0.29|0.3015
91778281|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.7534|TWO_SIDED|95.0|0.15|3.94|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 18 Months||3.94|0.15|0.7534
91778282|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
91778283|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.1177|TWO_SIDED|95.0|0.61|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.06|0.61|0.1177
91778284|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.273|TWO_SIDED|95.0|0.88|1.56|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.56|0.88|0.2730
91646910|NCT02058368|183185342|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.009|TWO_SIDED|95.0|-1.23|-0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.18|-1.23|0.009
91646911|NCT02058368|183185347|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-2.1|-1.6||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.6|-2.1|<.001
91646912|NCT02058368|183185347|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-2.3|-1.9||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.9|-2.3|<.001
91646913|NCT02058368|183185347|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.1|-2.2||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-2.2|-3.1|<.001
91646914|NCT02058368|183185349|SUPERIORITY|||||||0.77||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6|Van Elteren test|||||||0.77
91646915|NCT02058368|183185349|SUPERIORITY|||||||0.84||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12|Van Elteren test|||||||0.84
91778285|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9306|TWO_SIDED|95.0|0.73|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.33|0.73|0.9306
91646916|NCT02058368|183185349|SUPERIORITY|||||||0.98||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18|Van Elteren test|||||||0.98
91646917|NCT02058368|183185349|SUPERIORITY|||||||0.28||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24|Van Elteren test|||||||0.28
91646918|NCT02441179|183185369|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||||||0.006
91646919|NCT02441179|183185370|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||||||0.012
91646920|NCT02441179|183185371|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Kruskal-Wallis|||||||0.16
91646921|NCT02441179|183185372|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
91646922|NCT02441179|183185373|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
91708473|NCT00856843|183309811|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
91708474|NCT00856843|183309812|SUPERIORITY_OR_OTHER|||||||0.013|||||||Chi-squared|||||||0.013
91708475|NCT00856843|183309813|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
91708476|NCT01900431|183309824|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2354|TWO_SIDED|90.0|0.8|5.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using combined estimate for odds ratio obtained by combining the log-transformation of odds ratio from Cochran Mantel-Haenszel (CMH) analyses of the different imputed datasets, using Rubin's formulae, and then by back-transforming the combined estimate. The CMH analyses were adjusted for randomization stratification factor VH level (VH \>= 4 versus VH \<4).||5.6|0.8|0.2354
91708477|NCT01900431|183309825|SUPERIORITY||Least Square (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0127|TWO_SIDED|90.0|-1.223|-0.262||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using mixed effect model with repeated measures (MMRM) with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline adjudicated VH.||-0.262|-1.223|0.0127
91708478|NCT01900431|183309826|SUPERIORITY||Odds Ratio (OR)|0.95||||1|TWO_SIDED|90.0|0.11|6.093||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||6.093|0.11|1
91708479|NCT01900431|183309827|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|2.26||0.0153|TWO_SIDED|90.0|1.99|9.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.||9.67|1.99|0.0153
91708480|NCT01900431|183309828|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|14.2||0.0683|TWO_SIDED|90.0|-50.41|-2.68||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-2.68|-50.41|0.0683
91708481|NCT01900431|183309829|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.55||0.0825|TWO_SIDED|90.0|-12.374|-0.35||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-0.35|-12.374|0.0825
91708482|NCT01900431|183309832|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|90.0|0.306|3.845||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||3.845|0.306|1
91778286|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8631|TWO_SIDED|95.0|0.72|1.32|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.32|0.72|0.8631
91646923|NCT02441179|183185374|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
91646924|NCT02441179|183185375|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
91584494|NCT03401229|183059117|SUPERIORITY||Mean Difference (Net)|-0.287||||0.0032|TWO_SIDED|95.0|-0.477|-0.096||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NBS is similar between benralizumab and placebo. H1: The change from baseline in NBS is different between benralizumab and placebo.||-0.096|-0.477|0.0032
91584495|NCT03401229|183059118|SUPERIORITY||Mean Difference (Net)|-7.492||||0.0188|TWO_SIDED|95.0|-13.741|-1.243||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||-1.243|-13.741|0.0188
91584496|NCT03401229|183059119|SUPERIORITY||Mean Difference (Net)|-0.237||||0.0023|TWO_SIDED|95.0|-0.389|-0.084||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.084|-0.389|0.0023
91584497|NCT03401229|183059120|SUPERIORITY||Mean Difference (Net)|-0.856||||0.2375|TWO_SIDED|95.0|-2.281|0.57||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following WP (WP for NP surgery), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the changes from baseline LMS score of benralizumab with placebo. H0: The change from baseline in LMS score is similar between benralizumab and placebo. H1: The change from baseline in LMS score is different between benralizumab and placebo.||0.570|-2.281|0.2375
91584498|NCT03401229|183059121|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5419|TWO_SIDED|95.0|0.51|1.43||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.43|0.51|0.5419
91584499|NCT03401229|183059122|SUPERIORITY||Odds Ratio (OR)|0.69||||0.0913|TWO_SIDED|95.0|0.44|1.06||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.06|0.44|0.0913
91708483|NCT00603382|183309859|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.101||||0.095|TWO_SIDED|95.0|-0.018|0.221|||ANCOVA|||||0.221|-0.018|0.095
91708484|NCT00603382|183309859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129||||0.033|TWO_SIDED|95.0|0.011|0.247|||ANCOVA|||||0.247|0.011|0.033
91708485|NCT00603382|183309859|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.089|0.319|||ANCOVA|||||0.319|0.089|<0.001
91708486|NCT00603382|183309859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.111|0.349|||ANCOVA|||||0.349|0.111|<0.001
91778287|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.0977|TWO_SIDED|95.0|0.95|1.86|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.86|0.95|0.0977
91778288|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.43||||0.0726|TWO_SIDED|95.0|0.97|2.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||2.10|0.97|0.0726
91708487|NCT00603382|183309859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.074|TWO_SIDED|95.0|-0.01|0.223|||ANCOVA|||||0.223|-0.010|0.074
91778289|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9974|TWO_SIDED|95.0|0.73|1.38|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.38|0.73|0.9974
91708488|NCT01078298|183309912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35|||<|0.0001|TWO_SIDED|95.0|2.16|5.21|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.21|2.16|<0.0001
91778290|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7069|TWO_SIDED|95.0|0.72|1.63|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.63|0.72|0.7069
91778291|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.3||||0.3068|TWO_SIDED|95.0|0.78|2.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.16|0.78|0.3068
91778292|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.64||||0.1375|TWO_SIDED|95.0|0.85|3.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.16|0.85|0.1375
91778293|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.954|TWO_SIDED|95.0|0.46|2.29|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||2.29|0.46|0.9540
91584500|NCT03401229|183059123|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0362|TWO_SIDED|95.0|0.44|0.97||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery or SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||0.97|0.44|0.0362
91584501|NCT03401229|183059124|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1505|TWO_SIDED|95.0|0.53|1.1||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.10|0.53|0.1505
91708489|NCT01078298|183309913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.56|4.1|||Regression, Logistic|||For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||4.10|1.56|0.0001
91708490|NCT01078298|183309913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0011|TWO_SIDED|95.0|1.4|3.98|||Regression, Logistic|||For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||3.98|1.40|0.0011
91708491|NCT01078298|183309914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.53|5.78|||Regression, Logistic|||For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.78|2.53|<0.0001
91584502|NCT03401229|183059128|SUPERIORITY||Rate Ratio|0.79||||0.2189|TWO_SIDED|95.0|0.54|1.15||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Negative Bionomial Model|Model included treatment, US/non-US and prior use of SCS\_NP with total number of courses of SCS\_NP as outcome and log of follow-up time as an offset||The endpoint compared the rate of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Rate ratio is benralizumab vs placebo and Rate ratio less than 1 indicates less likely of SCS\_NP use.||1.15|0.54|0.2189
91584503|NCT03401229|183059129|SUPERIORITY||Median Difference (Net)|-1.854||||0.0036|TWO_SIDED|95.0|-3.101|-0.608||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.608|-3.101|0.0036
91584504|NCT03401229|183059130|SUPERIORITY||Mean Difference (Net)|-0.166||||0.0941|TWO_SIDED|95.0|-0.36|0.028||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||0.028|-0.360|0.0941
91584505|NCT03401229|183059131|SUPERIORITY||Mean Difference (Net)|-0.213||||0.0246|TWO_SIDED|95.0|-0.399|-0.027||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.027|-0.399|0.0246
91584506|NCT03401229|183059132|SUPERIORITY||Mean Difference (Net)|0.672||||0.5833|TWO_SIDED|95.0|-1.73|3.074||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||3.074|-1.730|0.5833
91584507|NCT03401229|183059133|SUPERIORITY||Median Difference (Net)|2.684||||0.0619|TWO_SIDED|95.0|-0.134|5.502||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||5.502|-0.134|0.0619
91708492|NCT01078298|183309914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0004|TWO_SIDED|95.0|1.4|3.33|||Regression, Logistic|||For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.33|1.40|0.0004
91778294|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.53||||0.4283|TWO_SIDED|95.0|0.1|2.64|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||2.64|0.10|0.4283
91778295|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-95.56|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-95.56|
91778296|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.2153|TWO_SIDED|95.0|0.64|1.1|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 3 Day 1||1.10|0.64|0.2153
91778297|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7878|TWO_SIDED|95.0|0.73|1.27|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 5 Day 1||1.27|0.73|0.7878
91778298|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.81||||0.1544|TWO_SIDED|95.0|0.61|1.08|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 8 Day 1||1.08|0.61|0.1544
91778299|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8017|TWO_SIDED|95.0|0.77|1.4|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 12 Day 1||1.40|0.77|0.8017
91778300|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4295|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 16 Day 1||1.21|0.63|0.4295
91778301|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio, log|0.99||||0.954|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 20 Day 1||1.44|0.68|0.9540
91778302|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7494|TWO_SIDED|95.0|0.69|1.3|||Cochran-Mantel-Haenszel|||Social Functioning, Completion of Treatment/ Early Termination Visit||1.30|0.69|0.7494
91778303|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6412|TWO_SIDED|95.0|0.74|1.62|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 3 Months||1.62|0.74|0.6412
91778304|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8652|TWO_SIDED|95.0|0.65|1.67|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 6 Months||1.67|0.65|0.8652
91778305|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6912|TWO_SIDED|95.0|0.6|2.18|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 9 Months||2.18|0.60|0.6912
91778306|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.5834|TWO_SIDED|95.0|0.33|1.86|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 12 Months||1.86|0.33|0.5834
91584508|NCT03401229|183059134|SUPERIORITY||Median Difference (Net)|-5.057||||0.102|TWO_SIDED|95.0|-11.129|1.015||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|Following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||1.015|-11.129|0.1020
91584509|NCT01776424|183059171|SUPERIORITY||Hazard Ratio (HR)|0.76||||4e-05|TWO_SIDED|95.0|0.66|0.86||Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(\~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.86|0.66|0.00004
91584510|NCT01776424|183059171|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1149|TWO_SIDED|95.0|0.79|1.03|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.03|0.79|0.11490
91584511|NCT01776424|183059172|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|1e-05|TWO_SIDED|95.0|1.4|2.05|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||2.05|1.40|<0.00001
91584512|NCT01776424|183059172|SUPERIORITY||Hazard Ratio (HR)|1.51||||3e-05|TWO_SIDED|95.0|1.25|1.84|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.84|1.25|0.00003
91584513|NCT01776424|183059173|SUPERIORITY||Hazard Ratio (HR)|0.72||||1e-05|TWO_SIDED|95.0|0.63|0.83||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.83|0.63|0.00001
91584514|NCT01776424|183059173|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.06437|TWO_SIDED|95.0|0.77|1.01||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.01|0.77|0.06437
91584515|NCT01776424|183059174|SUPERIORITY||Hazard Ratio (HR)|0.74||||1e-05|TWO_SIDED|95.0|0.65|0.85||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.85|0.65|0.00001
91584516|NCT01776424|183059174|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.03995||95.0|0.77|0.99||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.99|0.77|0.03995
91584517|NCT01776424|183059175|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.01062|TWO_SIDED|95.0|0.71|0.96||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.96|0.71|0.01062
91584518|NCT01776424|183059175|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66418|TWO_SIDED|95.0|0.84|1.12||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.12|0.84|0.66418
91646925|NCT01488071|183185376|NON_INFERIORITY_OR_EQUIVALENCE|"Mixed model for repeated measurements (MMRM), using all available data, with a freely varying mean and covariance structures and with treatment, week, and site group as fixed factors and the baseline score as a covariate. The model also included interaction between week and baseline score, as well as interaction between week and treatment.~Non-inferiority, upper limit of Confidence Interval should not exceed 2."|Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.69||0.0018|TWO_SIDED|95.0|-3.51|-0.81||Under established non-inferiority the p-value is not adjusted.|Mixed Models Analysis|MMRM||||-0.81|-3.51|0.0018
91646926|NCT01488071|183185377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.72||0.0054|TWO_SIDED|95.0|-3.45|-0.6||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.60|-3.45|0.0054
91646927|NCT01488071|183185378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.56||0.0008|TWO_SIDED|95.0|-2.98|-0.8||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.80|-2.98|0.0008
91584519|NCT00819390|183059183|SUPERIORITY_OR_OTHER|||||||0.428||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.428
91646928|NCT01488071|183185379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.57||0.0007|TWO_SIDED|95.0|-3.04|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.04|0.0007
91646929|NCT01488071|183185380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0023|TWO_SIDED|95.0|-0.48|-0.11||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.11|-0.48|0.0023
91584520|NCT00819390|183059183|SUPERIORITY_OR_OTHER|||||||0.247||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments.||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.247
91646930|NCT01488071|183185381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.0075|TWO_SIDED|95.0|-0.47|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.47|0.0075
91584521|NCT02294227|183059212|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0002|TWO_SIDED|95.0|1.66|5.66|||Chi-squared|||||5.66|1.66|0.0002
91584522|NCT02294227|183059212|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0003|TWO_SIDED|95.0|1.76|5.97|||Chi-squared, Corrected|||||5.97|1.76|0.0003
91584523|NCT00887432|183059218|SUPERIORITY||Mean Difference (Net)|0.24||||0.431|TWO_SIDED|95.0|-0.36|0.84||Significance level of 0.05.|t-test, 2 sided|Paired t-test, df=86||Evaluated the change in PSA under the vitamin D and placebo conditions using the combined data (n=87).||0.84|-0.36|0.431
91584524|NCT00887432|183059219|SUPERIORITY|Comparing the mean PSA slopes between conditions (on vitamin D versus on placebo).|Mean Difference (Net)|-0.00019||||0.112|TWO_SIDED|95.0|-0.00042|0.000045||Significance level of 0.05.|Mixed Models Analysis|||||0.000045|-0.00042|0.112
91646931|NCT01488071|183185382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0048|TWO_SIDED|95.0|-0.42|-0.08||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.08|-0.42|0.0048
91646932|NCT01488071|183185383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0055|TWO_SIDED|95.0|-0.42|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.42|0.0055
91646933|NCT01488071|183185384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0012|TWO_SIDED|95.0|1.26|2.6||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.60|1.26|0.0012
91646934|NCT01488071|183185385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0014|TWO_SIDED|95.0|1.26|2.65||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.65|1.26|0.0014
91646935|NCT01488071|183185386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0054|TWO_SIDED|95.0|1.17|2.52||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.52|1.17|0.0054
91646936|NCT01488071|183185387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0002|TWO_SIDED|95.0|1.39|2.9||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.90|1.39|0.0002
91646937|NCT01488071|183185388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.72||0.0021|TWO_SIDED|95.0|-3.63|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.63|0.0021
91646938|NCT01488071|183185389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.75||0.0209|TWO_SIDED|95.0|-3.23|-0.27||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.27|-3.23|0.0209
91646939|NCT02139306|183185390|SUPERIORITY||Mean Difference (Net)|0.597|STANDARD_ERROR_OF_MEAN|0.957||0.5336|TWO_SIDED|95.0|-1.2881|2.4813|||Mixed-model, repeated-measures|||||2.4813|-1.2881|0.5336
91708493|NCT01078298|183309914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.002|TWO_SIDED|95.0|1.28|3.08|||Regression, Logistic|||For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.28|0.0020
91646940|NCT02139306|183185391|SUPERIORITY||Rate ratio|0.8567|STANDARD_ERROR_OF_MEAN|0.1577||0.4008|TWO_SIDED|95.0|0.5973|1.2288|||Negative binomial regression|||||1.2288|0.5973|0.4008
91646941|NCT02139306|183185392|SUPERIORITY||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.93||0.8881|TWO_SIDED|95.0|-3.5292|4.0731|||Mixed-model, repeated measures|||||4.0731|-3.5292|0.8881
91646942|NCT02139306|183185393|SUPERIORITY||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.1312||0.6208|TWO_SIDED|95.0|-0.3233|0.1934|||Mixed-model, repeated measures|||||0.1934|-0.3233|0.6208
91646943|NCT02278952|183185411|OTHER|Generalized estimating equation-adjusted linear models||||||0.33|||||||GEE-adjusted models|||||||0.33
91646944|NCT02278952|183185412|OTHER|Generalized estimating equation-adjusted linear model|||||<|0.0001|||||||GEE-adjusted linear model|||||||< 0.0001
91708494|NCT01078298|183309915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0027|TWO_SIDED|95.0|1.26|3.08|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.26|0.0027
91646945|NCT02278952|183185413|OTHER|Generalized estimating equation-adjusted linear models||||||0.049|||||||GEE-adjusted linear models|||||||0.049
91646946|NCT02278952|183185414|OTHER|Generalized estimating equation-adjusted linear models||||||0.114|||||||GEE-adjusted linear models|||||||0.114
91646947|NCT02278952|183185415|OTHER|Generalized estimating equation-adjusted linear models||||||0.47|||||||GEE-adjusted linear models|||P-value of tacrolimus dose||||0.470
91646948|NCT02278952|183185415|OTHER|Generalized estimating equation-adjusted linear models||||||0.037|||||||GEE-adjusted linear models|||P-value of Prednisone dose||||0.037
91646949|NCT02278952|183185415|OTHER|Generalized-estimating equation-adjusted linear models||||||0.456|||||||GEE-adjusted linear models|||P-value of mycophenolate mofetil dose||||0.456
91708495|NCT02798354|183309926|SUPERIORITY||Risk Difference (RD)|3.9|||<|0.0001|TWO_SIDED|95.0|2.4|5.3|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||5.3|2.4|<0.0001
91646950|NCT02787746|183185450|OTHER||Odds Ratio (OR)|0.988||||0.9744|TWO_SIDED|95.0|0.466|2.095|||Regression, Logistic|||Age (\>75y vs ≤75y）||2.095|0.466|0.9744
91646951|NCT02787746|183185450|OTHER||Odds Ratio (OR)|3.42||||0.3288|TWO_SIDED|95.0|0.29|40.354|||Regression, Logistic|||APOE ɛ4 (carrier vs non-carrier)||40.354|0.290|0.3288
91646952|NCT02787746|183185450|OTHER||Odds Ratio (OR)|2.107||||0.5732|TWO_SIDED|95.0|0.158|28.171|||Regression, Logistic|||Concomitant medication：Gastrointestinal drugs||28.171|0.158|0.5732
91646953|NCT02787746|183185450|OTHER||Odds Ratio (OR)|0.976||||0.9694|TWO_SIDED|95.0|0.281|3.387|||Regression, Logistic|||Concomitant medication：Hypoglycemic drugs||3.387|0.281|0.9694
91646954|NCT02787746|183185450|OTHER||Odds Ratio (OR)|2.221||||0.0396|TWO_SIDED|95.0|1.039|4.748|||Regression, Logistic|||Concomitant medication：Cardiovascular and Cerebrovascular drugs||4.748|1.039|0.0396
91646955|NCT02787746|183185450|OTHER||Odds Ratio (OR)|2.056||||0.5889|TWO_SIDED|95.0|0.151|28.074|||Regression, Logistic|||Concomitant medication：Hepatology drugs||28.074|0.151|0.5889
91646956|NCT02787746|183185450|OTHER||Odds Ratio (OR)|1.004||||0.1181|TWO_SIDED|95.0|0.999|1.008|||Regression, Logistic|||Duration of previous donepezil 5mg/d therapy (day)||1.008|0.999|0.1181
91584525|NCT00899548|183059221|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0002|TWO_SIDED|95.0|1.23|2.52|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.52|1.23|.0002
91646957|NCT01142466|183185460|SUPERIORITY_OR_OTHER|||||||0.1384|||||||Log Rank|||Two-sided log rank test with alpha equal to 0.05 was used as the appropriate nonparametric method to compare the two groups.||||0.1384
91778307|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.9578|TWO_SIDED|95.0|0.05|16.05|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 18 Months||16.05|0.05|0.9578
91778308|NCT03038100|183438015|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
91778309|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.6063|TWO_SIDED|95.0|0.75|1.63|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.63|0.75|0.6063
91778310|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.5739|TWO_SIDED|95.0|0.63|1.29|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.29|0.63|0.5739
91778311|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.3792|TWO_SIDED|95.0|0.56|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.25|0.56|0.3792
91778312|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6022|TWO_SIDED|95.0|0.73|1.73|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.73|0.73|0.6022
91778313|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.7893|TWO_SIDED|95.0|0.59|1.49|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.49|0.59|0.7893
91778314|NCT03038100|183438016|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2125|TWO_SIDED|95.0|0.42|1.22|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.22|0.42|0.2125
91778315|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9661|TWO_SIDED|95.0|0.7|1.46|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion of Treatment/ Early Termination Visit||1.46|0.70|0.9661
91778316|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.4299|TWO_SIDED|95.0|0.52|1.32|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.32|0.52|0.4299
91778317|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.1542|TWO_SIDED|95.0|0.36|1.18|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||1.18|0.36|0.1542
91584526|NCT00899548|183059222|OTHER||Cox Proportional Hazard|1.19||||0.001|TWO_SIDED|95.0|1.07|1.32|||Regression, Cox|||Hazard ratio||1.32|1.07|0.001
91584527|NCT00899548|183059225|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.001|TWO_SIDED|95.0|1.18|2.45|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.45|1.18|.001
91646958|NCT01142466|183185461|SUPERIORITY_OR_OTHER|||||||0.2635||95.0|||||Fisher Exact|||||||0.2635
91646959|NCT04084028|183185467|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
91646960|NCT04084028|183185468|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91778318|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.65||||0.0363|TWO_SIDED|95.0|1.04|6.76|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||6.76|1.04|0.0363
91778319|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.75||||0.0814|TWO_SIDED|95.0|0.85|8.93|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||8.93|0.85|0.0814
91778320|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|4.03||||0.1915|TWO_SIDED|95.0|0.43|38.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||38.00|0.43|0.1915
91778321|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|66.67||||0.3173|TWO_SIDED|95.0|-4.39|100.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 24 Months||100.00|-4.39|0.3173
91778322|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9818|TWO_SIDED|95.0|0.73|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.35|0.73|0.9818
91778323|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.6263|TWO_SIDED|95.0|0.8|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.45|0.80|0.6263
91778324|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9407|TWO_SIDED|95.0|0.73|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.73|0.9407
91778325|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.64|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.39|0.64|0.7700
91778326|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8458|TWO_SIDED|95.0|0.63|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.45|0.63|0.8458
91778327|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.7028|TWO_SIDED|95.0|0.57|1.46|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.46|0.57|0.7028
91778328|NCT03038100|183438016|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1391|TWO_SIDED|95.0|0.92|1.83|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.83|0.92|0.1391
91778329|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.8002|TWO_SIDED|95.0|0.69|1.62|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.62|0.69|0.8002
91778330|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9751|TWO_SIDED|95.0|0.6|1.68|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.68|0.60|0.9751
91778331|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.3811|TWO_SIDED|95.0|0.68|2.78|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||2.78|0.68|0.3811
91778332|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.395|TWO_SIDED|95.0|0.58|3.9|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||3.90|0.58|0.3950
91584528|NCT00953745|183059279|SUPERIORITY_OR_OTHER|||||||0.029||||||paired t-test thresholded at cluster level significance of p=0.001; family-wise error multiple comparisons corrected|t-test, 1 sided|||A region of increased relative Fluorodopa (FDOPA) uptake in the right medial caudate was anticipated for the aripiprazole augmentation responders over the 6 weeks of augmentation treatment (Weeks 10-16).||||0.029
91646961|NCT04084028|183185469|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
91646962|NCT04084028|183185470|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||.19
91646963|NCT04084028|183185471|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||.77
91646964|NCT04084028|183185472|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||.06
91646965|NCT01160198|183185498|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 once-daily||||<0.0001
91646966|NCT01160198|183185498|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 twice-daily||||<0.0001
91646967|NCT01160198|183185500|SUPERIORITY_OR_OTHER|||||||0.788|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily||||0.788
91708496|NCT02798354|183309927|SUPERIORITY||Risk Difference (RD)|16.0|||<|0.0001|TWO_SIDED|95.0|12.3|20.0|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||20|12.3|<0.0001
91584529|NCT00953745|183059280|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91584530|NCT00953745|183059280|SUPERIORITY_OR_OTHER|||||||0.366|||||||t-test, 2 sided|||||||0.366
91584531|NCT00600886|183059291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.942||||0.007|TWO_SIDED|95.0|1.19|3.168|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel adjusting for randomization stratification factor||Overall - All patients||3.168|1.190|0.007
91584532|NCT00600886|183059291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.337|||||TWO_SIDED|95.0|1.14|4.79||||||Post surgery - patients with prior surgery but no previous medical treatment for acromegaly||4.790|1.140|
91584533|NCT00600886|183059291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.654|||||TWO_SIDED|95.0|0.846|3.234||||||De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.||3.234|0.846|
91646968|NCT01160198|183185500|SUPERIORITY_OR_OTHER|||||||0.911|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.911
91646969|NCT01160198|183185500|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.700
91584534|NCT03075410|183059347|OTHER||Ratio|1.07|||||TWO_SIDED|90.0|0.87|1.34|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.34|0.87|
91584535|NCT03075410|183059348|OTHER||Ratio|0.94|||||TWO_SIDED|90.0|0.71|1.26|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-inf). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is use|||1.26|0.71|
91646970|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.17|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 2||0.17|-0.29|1
91646971|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1||95.0|-0.57|0.31|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 4||0.31|-0.57|1
91646972|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.75|0.46|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 6||0.46|-0.75|1
91646973|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||1|TWO_SIDED|95.0|-1.05|0.53|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 8||0.53|-1.05|1
91646974|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.49|TWO_SIDED|95.0|-0.35|0.09|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.09|-0.35|0.490
91646975|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-0.58|0.29|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.29|-0.58|1
91646976|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.68|0.51|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.51|-0.68|1
91646977|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.84|0.72|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.72|-0.84|1
91646978|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.15|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.15|-0.29|1
91646979|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.45|0.42|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.42|-0.45|1
91708497|NCT02798354|183309928|SUPERIORITY||Risk Difference (RD)|1.1||||0.302|TWO_SIDED|95.0|-1.0|3.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||3.1|-1.0|0.302
91708498|NCT02798354|183309929|SUPERIORITY||Risk Difference (RD)|26.6|||<|0.0001|TWO_SIDED|95.0|22.4|30.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||30.7|22.4|<0.0001
91584536|NCT03075410|183059349|OTHER||Ratio|0.97|||||TWO_SIDED|90.0|0.76|1.23|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.23|0.76|
91584537|NCT03075410|183059350|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.64|1.23|||||Fixed Effect Model has been used to assess Food Effect for the log transformed parameter t1/2 Treatment in the fed/fasted state is fitted as Fixed Effect.|||1.23|0.64|
91584538|NCT03075410|183059351|OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|-0.5|2.5|||||Hodges-Lehmann estimation is used to calculate the 90% confidence interval.|||2.50|-0.50|
91584539|NCT03075410|183059355|OTHER||Slope|1.1|||||TWO_SIDED|90.0|1.09|1.1|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 5mg Day 1-14||1.10|1.09|
91584540|NCT03075410|183059355|OTHER||Slope|1.08|||||TWO_SIDED|90.0|1.07|1.08|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 15mg Day 1-14||1.08|1.07|
91584541|NCT03075410|183059356|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.82|1.1|||||A slope of 1 indicates the pharmacokinetics are dose proportional. A slope greater than 1 indicates the increase in PK is greater than proportional to dose.||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|1.10|0.82|
91778333|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.8993|TWO_SIDED|95.0|0.16|5.12|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||5.12|0.16|0.8993
91778334|NCT03038100|183438016|SUPERIORITY|Stratified|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
91778335|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5988|TWO_SIDED|95.0|0.68|1.25|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.25|0.68|0.5988
91778336|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8859|TWO_SIDED|95.0|0.72|1.34|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.34|0.72|0.8859
91778337|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.2531|TWO_SIDED|95.0|0.58|1.16|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Cycle 8 Day 1||1.16|0.58|0.2531
91778338|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.0785|TWO_SIDED|95.0|0.46|1.04|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.04|0.46|0.0785
91778339|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.67||||0.0641|TWO_SIDED|95.0|0.43|1.03|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.03|0.43|0.0641
91778340|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.48||||0.0046|TWO_SIDED|95.0|0.29|0.8|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||0.80|0.29|0.0046
91584542|NCT03075410|183059357|OTHER||Slope|1.32|||||TWO_SIDED|90.0|1.24|1.39|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.39|1.24|
91584543|NCT03075410|183059358|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.81|1.11|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.11|0.81|
91584544|NCT03075410|183059359|OTHER||Slope|1.24|||||TWO_SIDED|90.0|1.15|1.33|||||Day 1.Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.33|1.15|
91584545|NCT03075410|183059359|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.9|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.90|
91584546|NCT03075410|183059360|OTHER||Slope|1.19|||||TWO_SIDED|90.0|0.92|1.46|||||Day 1. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.46|0.92|
91584547|NCT03075410|183059360|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.89|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.89|
91778341|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8928|TWO_SIDED|95.0|0.7|1.37|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.37|0.70|0.8928
91778342|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6106|TWO_SIDED|95.0|0.72|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.72|0.6106
91778343|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.6159|TWO_SIDED|95.0|0.67|1.95|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.95|0.67|0.6159
91778344|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.5372|TWO_SIDED|95.0|0.62|2.49|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Post-Treatment Follow Up 9 Months||2.49|0.62|0.5372
91778345|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22||||0.0845|TWO_SIDED|95.0|0.89|5.58|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||5.58|0.89|0.0845
91778346|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.67||||0.1344|TWO_SIDED|95.0|0.62|21.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||21.56|0.62|0.1344
91778347|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
91778348|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.026|TWO_SIDED|95.0|1.04|1.92|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.92|1.04|0.0260
91778349|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9179|TWO_SIDED|95.0|0.75|1.37|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.37|0.75|0.9179
91778350|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.582|TWO_SIDED|95.0|0.79|1.53|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.53|0.79|0.5820
91584548|NCT04546789|183059368|OTHER||Ratio of geometric least squares mean|1.25|||||TWO_SIDED|90.0|0.86|1.82||||||Mild Hepatic Impairment vs Normal Hepatic Function||1.82|0.86|
91584549|NCT04546789|183059368|OTHER||Ratio of geometric least square mean|1.95|||||TWO_SIDED|90.0|1.6|2.38||||||Moderate hepatic impairment vs Normal hepatic impairment||2.38|1.60|
91646980|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-0.53|0.65|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.65|-0.53|1
91646981|NCT01160198|183185501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||1|TWO_SIDED|95.0|-0.58|0.98|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.98|-0.58|1
91646982|NCT00802529|183185503|SUPERIORITY_OR_OTHER|||||||0.271||||||P-value for Drug x Time interaction.|ANOVA|Time: 2 degrees of freedom (Baseline vs 18-24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.271
91584550|NCT04546789|183059369|OTHER||Ratio of geometric least square mean|1.24|||||TWO_SIDED|90.0|0.77|1.99||||||Mild Hepatic Impairment vs Normal Hepatic Function||1.99|0.77|
91584551|NCT04546789|183059369|OTHER||Ratio of geometric least square mean|1.85|||||TWO_SIDED|90.0|1.51|2.26||||||Moderate Hepatic Impairment vs Normal Hepatic Function||2.26|1.51|
91584552|NCT04546789|183059396|OTHER||Ratio of geometric least square mean|0.8|||||TWO_SIDED|90.0|0.55|1.17||||||Mild Hepatic Impairment vs Normal Hepatic Function||1.17|0.55|
91584553|NCT04546789|183059396|OTHER||Ratio of geometric least square mean|0.51|||||TWO_SIDED|90.0|0.42|0.63||||||Moderate Hepatic Impairment vs Normal Hepatic Function||0.63|0.42|
91584554|NCT04546789|183059399|OTHER||Ratio of geometric least square mean|1.44|||||TWO_SIDED|90.0|0.93|2.25||||||Mild Hepatic Impairment vs Normal Hepatic Function||2.25|0.93|
91584555|NCT04546789|183059399|OTHER||Ratio of geometric least square mean|2.55|||||TWO_SIDED|90.0|1.98|3.29||||||Moderate Hepatic Impairment vs Normal Hepatic Function||3.29|1.98|
91584556|NCT04546789|183059400|OTHER||Ratio of geometric least square mean|1.43|||||TWO_SIDED|90.0|0.86|2.39||||||Mild Hepatic Impairment vs Normal Hepatic Function||2.39|0.86|
91584557|NCT04546789|183059400|OTHER||Ratio of geometric least square mean|2.42|||||TWO_SIDED|90.0|1.87|3.14||||||Moderate Hepatic Impairment vs Normal Hepatic Function||3.14|1.87|
91584558|NCT04546789|183059401|OTHER||Ratio of geometric least square mean|0.69|||||TWO_SIDED|90.0|0.45|1.08||||||Mild Hepatic Impairment vs Normal Hepatic Function||1.08|0.45|
91584559|NCT04546789|183059401|OTHER||Ratio of geometric least square mean|0.39|||||TWO_SIDED|90.0|0.3|0.5||||||Moderate Hepatic Impairment vs Normal Hepatic Function||0.50|0.30|
91584560|NCT04016558|183059434|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.007|TWO_SIDED||||||ANCOVA|||||||.007
91646983|NCT00802529|183185504|SUPERIORITY_OR_OTHER|||||||0.964||||||P-value for Drug x Time interaction.|ANOVA|Time: 6 degrees of freedom (Baseline, 1, 2, 6, 12, 18 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.964
91646984|NCT00802529|183185505|SUPERIORITY_OR_OTHER|||||||0.128||||||P-value for Drug x Time interaction.|ANOVA|Time: 5 degrees of freedom (Baseline, 1, 2, 6, 12 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.128
91584561|NCT04016558|183059435|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.006|TWO_SIDED||||||ANCOVA|||||||.006
91646985|NCT02413879|183185506|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
91646986|NCT02413879|183185508|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
91584562|NCT04016558|183059436|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.82|TWO_SIDED||||||ANCOVA|||||||0.82
91584563|NCT04016558|183059437|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.01|TWO_SIDED||||||ANCOVA|||||||.01
91646987|NCT00337129|183185547|SUPERIORITY_OR_OTHER||Response probability|0.05|||||TWO_SIDED|95.0|0.01|0.17|||two-stage binomial|||Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.||0.17|0.01|
91584564|NCT04016558|183059438|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED||||||ANCOVA|||||||.40
91584565|NCT04016558|183059440|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.12|TWO_SIDED||||||ANCOVA|||||||.12
91584566|NCT04016558|183059441|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.39|TWO_SIDED||||||ANCOVA|||||||.39
91584567|NCT04016558|183059442|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
91584568|NCT03756129|183059459|SUPERIORITY||Median Difference (Net)|-8.25||||0.0013|TWO_SIDED|80.0|-11.67|-4.83|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-4.83|-11.67|0.0013
91584569|NCT03756129|183059459|SUPERIORITY||Mean Difference (Net)|-5.71||||0.0196|TWO_SIDED|80.0|-9.22|-2.2|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-2.20|-9.22|0.0196
91584570|NCT03756129|183059460|SUPERIORITY||Mean Difference (Net)|-7.06||||0.013|TWO_SIDED|80.0|-11.06|-3.06|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo."||-3.06|-11.06|0.0130
91584571|NCT03756129|183059460|SUPERIORITY||Median Difference (Net)|-7.37||||0.0133|TWO_SIDED|80.0|-11.57|-3.18|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo."||-3.18|-11.57|0.0133
91584572|NCT03756129|183059461|SUPERIORITY||Mean Difference (Net)|-5.09||||0.1082|TWO_SIDED|80.0|-10.37|0.19|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg weekly minus placebo."||0.19|-10.37|0.1082
91646988|NCT02580318|183185603|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)|t-test, 2 sided|||this p value is calculated for poor effort||||<0.0001
91778351|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9772|TWO_SIDED|95.0|0.67|1.47|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.47|0.67|0.9772
91778352|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.13|TWO_SIDED|95.0|0.49|1.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.10|0.49|0.1300
91778353|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.099|TWO_SIDED|95.0|0.4|1.08|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.08|0.40|0.0990
91778354|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7133|TWO_SIDED|95.0|0.76|1.5|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.50|0.76|0.7133
91778355|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.38||||0.1384|TWO_SIDED|95.0|0.9|2.11|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||2.11|0.90|0.1384
91778356|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.2895|TWO_SIDED|95.0|0.78|2.26|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.26|0.78|0.2895
91778357|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.55||||0.2221|TWO_SIDED|95.0|0.77|3.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.14|0.77|0.2221
91778358|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|7.37||||0.0005|TWO_SIDED|95.0|2.08|26.1|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||26.10|2.08|0.0005
91778359|NCT03038100|183438016|SUPERIORITY||Odds Ratio (OR)|3.72||||0.2171|TWO_SIDED|95.0|0.4|34.56|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||34.56|0.40|0.2171
91778360|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Role functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
91584573|NCT03756129|183059461|SUPERIORITY||Mean Difference (Net)|-5.42||||0.0993|TWO_SIDED|80.0|-10.83|-0.02|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg weekly minus placebo."||-0.02|-10.83|0.0993
91584574|NCT03756129|183059461|SUPERIORITY||Mean Difference (Net)|-6.46||||0.0598|TWO_SIDED|80.0|-11.78|-1.15|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg biweekly minus placebo."||-1.15|-11.78|0.0598
91584575|NCT03756129|183059461|SUPERIORITY||Mean Difference (Net)|-3.06||||0.2491|TWO_SIDED|80.0|-8.86|2.74|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg biweekly minus placebo."||2.74|-8.86|0.2491
91584576|NCT02186847|183059496|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7563|TWO_SIDED|95.0|0.77|1.73|||Log Rank|One-sided significance level = 0.10|Reference level = Chemoradiation|The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.||1.73|0.77|0.7563
91584577|NCT02186847|183059497|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.64|1.68|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.68|0.64|0.8910
91584578|NCT02186847|183059498|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-side significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
91584579|NCT02186847|183059499|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
91584580|NCT02186847|183059500|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6266|TWO_SIDED|95.0|0.47|1.8|||Chi-squared|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.80|0.47|0.6266
91584581|NCT02647320|183059577|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.157||0.755|TWO_SIDED|90.0|-0.211|0.309|||Mixed Model Repeated Measure|||Difference in change at week 12||0.309|-0.211|.755
91584582|NCT02647320|183059577|OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.161||0.512|TWO_SIDED|90.0|-0.16|0.371|||Mixed Model Repeated Measure|||Difference in change at week 12||0.371|-0.160|.512
91584583|NCT02647320|183059577|OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|90.0|-0.312|0.151|||Mixed Model Repeated Measure|||Difference in change at week 12||0.151|-0.312|.566
91584584|NCT02647320|183059577|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.002|TWO_SIDED|90.0|-0.655|-0.197|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.197|-0.655|.002
91584585|NCT02647320|183059578|OTHER||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|3.13||0.144|TWO_SIDED|90.0|-9.76|0.58|||Mixed Model Repeated Measure|||Difference in change at week 12||0.58|-9.76|.144
91584586|NCT02647320|183059578|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.16||0.773|TWO_SIDED|90.0|-6.14|4.31|||Mixed Model Repeated Measure|||Difference in change at week 12||4.31|-6.14|.773
91646989|NCT02580318|183185603|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)|t-test, 2 sided|||p value calculated for hyperventilation (immediate)||||<0.0001
91584587|NCT02647320|183059578|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.79||0.963|TWO_SIDED|90.0|-4.73|4.48|||Mixed Model Repeated Measure|||Difference in change at week 12||4.48|-4.73|.963
91584588|NCT02647320|183059578|OTHER||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.74||0.258|TWO_SIDED|90.0|-7.64|1.42|||Mixed Model Repeated Measure|||Difference in change at week 12||1.42|-7.64|.258
91584589|NCT02647320|183059579|OTHER||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5||0.228|TWO_SIDED|90.0|-15.74|2.43|||Mixed Model Repeated Measure|||Difference in change at week 12||2.43|-15.74|.228
91584590|NCT02647320|183059579|OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|5.51||0.894|TWO_SIDED|90.0|-8.36|9.84|||Mixed Model Repeated Measure|||Difference in change at week 12||9.84|-8.36|.894
91646990|NCT02580318|183185603|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 5 minutes)||||<0.0001
91646991|NCT02580318|183185603|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 10 minutes)||||<0.0001
91584591|NCT02647320|183059579|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.86||0.846|TWO_SIDED|90.0|-8.97|7.08|||Mixed Model Repeated Measure|||Difference in change at week 12||7.08|-8.97|.846
91584592|NCT02647320|183059579|OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|4.77||0.409|TWO_SIDED|90.0|-11.82|3.93|||Mixed Model Repeated Measure|||Difference in change at week 12||3.93|-11.82|.409
91584593|NCT02647320|183059580|OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.59||0.576|TWO_SIDED|90.0|-2.83|5.73|||Mixed Model Repeated Measure|||Difference in change at week 12||5.73|-2.83|.576
91584594|NCT02647320|183059580|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.62||0.646|TWO_SIDED|90.0|-5.53|3.12|||Mixed Model Repeated Measure|||Difference in change at week 12||3.12|-5.53|.646
91584595|NCT02647320|183059580|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.3||0.902|TWO_SIDED|90.0|-3.52|4.08|||Mixed Model Repeated Measure|||Difference in change at week 12||4.08|-3.52|.902
91584596|NCT02647320|183059580|OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.27||0.478|TWO_SIDED|90.0|-5.35|2.13|||Mixed Model Repeated Measure|||Difference in change at week 12||2.13|-5.35|.478
91584597|NCT02647320|183059581|OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.22||0.072|TWO_SIDED|90.0|-14.57|-0.64|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.64|-14.57|.072
91584598|NCT02647320|183059581|OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|4.26||0.794|TWO_SIDED|90.0|-8.15|5.92|||Mixed Model Repeated Measure|||Difference in change at week 12||5.92|-8.15|.794
91584599|NCT02647320|183059581|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.75||0.946|TWO_SIDED|90.0|-6.45|5.94|||Mixed Model Repeated Measure|||Difference in change at week 12||5.94|-6.45|.946
91708499|NCT02798354|183309930|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|16.2|24.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||24.1|16.2|<0.0001
91584600|NCT02647320|183059581|OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|3.68||0.431|TWO_SIDED|90.0|-8.99|3.18|||Mixed Model Repeated Measure|||Difference in change at week 12||3.18|-8.99|.431
91584601|NCT02647320|183059582|OTHER||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|8.54||0.228|TWO_SIDED|90.0|-24.43|3.78|||Mixed Model Repeated Measure|||Difference in change at week 12||3.78|-24.43|.228
91708500|NCT02798354|183309931|SUPERIORITY||Risk Difference (RD)|14.0|||<|0.0001|TWO_SIDED|95.0|10.3|17.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||17.7|10.3|<0.0001
91708501|NCT02798354|183309932|SUPERIORITY||Risk Difference (RD)|0.1||||0.922|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||1.9|-1.8|0.922
91708502|NCT00350779|183309955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|0.87|<|0.001||95.0|-0.95|-0.49|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.49|-0.95|<0.001
91708503|NCT00350779|183309956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0|STANDARD_DEVIATION|31.3|<|0.001||95.0|-27.2|-10.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-10.9|-27.2|<0.001
91708504|NCT00350779|183309957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|43.7|<|0.001||95.0|-50.2|-25.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-25.5|-50.2|<0.001
91708505|NCT00350779|183309958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|1.04|<|0.001||95.0|-1.04|-0.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.50|-1.04|<0.001
91708506|NCT00350779|183309959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.4|STANDARD_DEVIATION|34.6|<|0.001||95.0|-26.4|-8.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-8.4|-26.4|<0.001
91708507|NCT00350779|183309960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.1|STANDARD_DEVIATION|51.0|<|0.001||95.0|-48.4|-19.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-19.9|-48.4|<0.001
91708508|NCT00528372|183309961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1522||0.0207||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0207
91708509|NCT00528372|183309961|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1541||0.0005||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0005
91708510|NCT00528372|183309961|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.1518|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
91708511|NCT00528372|183309961|SUPERIORITY_OR_OTHER||Difference from placebo|-0.61|STANDARD_ERROR_OF_MEAN|0.1536|||TWO_SIDED|95.0|-0.91|-0.3||||||||-0.30|-0.91|
91708512|NCT00528372|183309961|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1527|||TWO_SIDED|95.0|-0.86|-0.26||||||||-0.26|-0.86|
91708513|NCT00528372|183309961|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1474|||TWO_SIDED|95.0|-0.85|-0.27||||||||-0.27|-0.85|
91708514|NCT00528372|183309962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|5.734||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|||Week 24|||||
91708515|NCT00528372|183309962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.806||0.0007||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||0.0007
91708516|NCT00528372|183309962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||<0.0001
91708517|NCT00528372|183309962|SUPERIORITY_OR_OTHER||Difference from placebo|-21.5|STANDARD_ERROR_OF_MEAN|5.686|||TWO_SIDED|95.0|-32.6|-10.3||||||||-10.3|-32.6|
91708518|NCT00528372|183309962|SUPERIORITY_OR_OTHER||Difference from placebo|-23.3|STANDARD_ERROR_OF_MEAN|5.711|||TWO_SIDED|95.0|-34.4|-12.0||||||||-12.0|-34.4|
91708519|NCT00528372|183309962|SUPERIORITY_OR_OTHER||Difference from placebo|-25.5|STANDARD_ERROR_OF_MEAN|5.567|||TWO_SIDED|95.0|-36.4|-14.5||||||||-14.5|-36.4|
91708520|NCT00528372|183309964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.6307||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.||||||||
91708521|NCT00528372|183309964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.6388||0.3101||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.3101
91708522|NCT00528372|183309964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.6223||0.1189||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.1189
91708523|NCT00528372|183309964|SUPERIORITY_OR_OTHER||Difference from placebo|-1.63|STANDARD_ERROR_OF_MEAN|0.6254|||TWO_SIDED|95.0|-2.86|-0.41||||||||-0.41|-2.86|
91708524|NCT00528372|183309964|SUPERIORITY_OR_OTHER||Difference from placebo|-1.36|STANDARD_ERROR_OF_MEAN|0.6279|||TWO_SIDED|95.0|-2.6|-0.13||||||||-0.13|-2.60|
91708525|NCT00528372|183309964|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
91708526|NCT00528372|183309966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.324||||||||||||||||
91646992|NCT02580318|183185603|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)|t-test, 2 sided|||p value calculated for drinking water (immediate)||||<0.0001
91646993|NCT02580318|183185603|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)|t-test, 2 sided|||p value calculated for drinking water (5 minutes)||||<0.0001
91646994|NCT03870737|183185628|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 24.81, df = 1/40.||Outcomes fitted via a mixed effects model with time as predictor.||||<.0001
91646995|NCT03870737|183185630|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Time: F = 5.78, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.02
91646996|NCT03870737|183185631|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Time: F = 14.28, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.0005
91646997|NCT03870737|183185632|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Time: F = .19, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.67
91646998|NCT03870737|183185633|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Time: F = .08, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.76
91646999|NCT03870737|183185634|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Time: F = .06, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.80
91647000|NCT02613416|183185645|OTHER|||||||0.026||||||The p value was calculated.|Blyth-Still Casella Confidence Interval|||The primary hypothesis for this early phase study was that at least 30% of women would experience a \>5% relative decrease in their breast density after 6 months of treatment with denosumab 120 mg subcutaneous dose once a month.||||0.026
91521152|NCT02954354|182917023|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
91647001|NCT00390949|183185649|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjustments for community pair, age-group and value of variable at baseline||||||<0.05
91708527|NCT00528372|183309966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|4.342||||||||||||||||
91708528|NCT00528372|183309966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|4.176||||||||||||||||
91708529|NCT00528372|183309966|SUPERIORITY_OR_OTHER||Difference from placebo|-12.0|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-20.3|-3.7||||||||-3.7|-20.3|
91708530|NCT00528372|183309966|SUPERIORITY_OR_OTHER||Difference from placebo|-16.2|STANDARD_ERROR_OF_MEAN|4.321|||TWO_SIDED|95.0|-24.7|-7.7||||||||-7.7|-24.7|
91521153|NCT02954354|182917023|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
91521154|NCT02954354|182917023|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0010
91521155|NCT02954354|182917023|SUPERIORITY|||||||0.0002||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0002
91521156|NCT02954354|182917024|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
91521157|NCT02954354|182917024|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
91521158|NCT02954354|182917024|SUPERIORITY|||||||0.4148||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4148
91521159|NCT02954354|182917024|SUPERIORITY|||||||0.0338||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0338
91521160|NCT02954354|182917024|SUPERIORITY|||||||0.9619||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9619
91521161|NCT02954354|182917024|SUPERIORITY|||||||0.8491||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.8491
91521162|NCT02954354|182917025|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
91521163|NCT02954354|182917026|SUPERIORITY|||||||0.0313||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0313
91521164|NCT02954354|182917027|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
91584602|NCT02647320|183059582|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.62||0.951|TWO_SIDED|90.0|-13.7|14.77|||Mixed Model Repeated Measure|||Difference in change at week 12||14.77|-13.70|.951
91584603|NCT02647320|183059582|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.59||0.852|TWO_SIDED|90.0|-13.96|11.13|||Mixed Model Repeated Measure|||Difference in change at week 12||11.13|-13.96|.852
91584604|NCT02647320|183059582|OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|7.45||0.608|TWO_SIDED|90.0|-16.13|8.48|||Mixed Model Repeated Measure|||Difference in change at week 12||8.48|-16.13|.608
91584605|NCT02647320|183059583|OTHER||LS Mean Difference|5.32|STANDARD_ERROR_OF_MEAN|15.289||0.728|TWO_SIDED|90.0|-19.932|30.566|||Mixed Model Repeated Measure|||Difference in change at week 4||30.566|-19.932|.728
91584606|NCT02647320|183059583|OTHER||LS Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|15.853||0.837|TWO_SIDED|90.0|-29.446|22.914|||Mixed Model Repeated Measure|||Difference in change at week 4||22.914|-29.446|.837
91584607|NCT02647320|183059583|OTHER||LS Mean Difference|-3.65|STANDARD_ERROR_OF_MEAN|13.747||0.791|TWO_SIDED|90.0|-26.352|19.051|||Mixed Model Repeated Measure|||Difference in change at week 4||19.051|-26.352|.791
91647002|NCT00390949|183185650|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value of variable at baseline||||||<0.05
91647003|NCT00390949|183185651|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|||||||<0.05
91647004|NCT00390949|183185652|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
91708531|NCT00528372|183309966|SUPERIORITY_OR_OTHER||Difference from placebo|-17.9|STANDARD_ERROR_OF_MEAN|4.228|||TWO_SIDED|95.0|-26.2|-9.5||||||||-9.5|-26.2|
91708532|NCT00528372|183309968|SUPERIORITY_OR_OTHER||Percentage difference|9.7||||||||||||||||||
91584608|NCT02647320|183059583|OTHER||LS Mean Difference|-40.03|STANDARD_ERROR_OF_MEAN|13.472||0.003|TWO_SIDED|90.0|-62.283|-17.787|||Mixed Model Repeated Measure|||Difference in change at week 4||-17.787|-62.283|.003
91584609|NCT02647320|183059584|OTHER||LS Mean Difference|4.39|STANDARD_ERROR_OF_MEAN|20.396||0.83|TWO_SIDED|90.0|-29.312|38.087|||Mixed Model Repeated Measure|||Difference in change at week 12||38.087|-29.312|.830
91584610|NCT02647320|183059584|OTHER||LS Mean Difference|24.25|STANDARD_ERROR_OF_MEAN|20.335||0.235|TWO_SIDED|90.0|-9.354|57.848|||Mixed Model Repeated Measure|||Difference in change at week 12||57.848|-9.354|.235
91584611|NCT02647320|183059584|OTHER||LS Mean Difference|17.25|STANDARD_ERROR_OF_MEAN|17.72||0.331|TWO_SIDED|90.0|-12.03|46.529|||Mixed Model Repeated Measure|||Difference in change at week 12||46.529|-12.030|.331
91584612|NCT02647320|183059584|OTHER||LS Mean Difference|-29.51|STANDARD_ERROR_OF_MEAN|17.393||0.091|TWO_SIDED|90.0|-58.254|-0.775|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.775|-58.254|.091
91708533|NCT00528372|183309968|SUPERIORITY_OR_OTHER||Percentage difference|12.6||||||||||||||||||
91708534|NCT00528372|183309968|SUPERIORITY_OR_OTHER||Percentage difference|19.2||||||||||||||||||
91708535|NCT00528372|183309968|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.8|||||TWO_SIDED|95.0|4.9|34.7||||||||34.7|4.9|
91708536|NCT00528372|183309968|SUPERIORITY_OR_OTHER||Percent difference from placebo|12.4|||||TWO_SIDED|95.0|-2.5|27.3||||||||27.3|-2.5|
91708537|NCT00528372|183309968|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.9|||||TWO_SIDED|95.0|5.3|34.5||||||||34.5|5.3|
91708538|NCT00528372|183309969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.6979||||||||||||||||
91708539|NCT00528372|183309969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.6828||||||||||||||||
91708540|NCT00528372|183309969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.6404||||||||||||||||
91708541|NCT00528372|183309969|SUPERIORITY_OR_OTHER||Difference from placebo|-1.55|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
91708542|NCT00528372|183309969|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
91708543|NCT00528372|183309969|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
91708544|NCT00528372|183309970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
91708545|NCT00528372|183309970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
91708546|NCT00528372|183309970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.1708||||||||||||||||
91708547|NCT00528372|183309970|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.1798|||TWO_SIDED|95.0|-0.95|-0.25||||||||-0.25|-0.95|
91708548|NCT00528372|183309970|SUPERIORITY_OR_OTHER||Difference from placebo|-0.55|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|95.0|-0.89|-0.21||||||||-0.21|-0.89|
91708549|NCT00528372|183309970|SUPERIORITY_OR_OTHER||Difference from placebo|-0.58|STANDARD_ERROR_OF_MEAN|0.1704|||TWO_SIDED|95.0|-0.92|-0.25||||||||-0.25|-0.92|
91708550|NCT00528372|183309971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|6.526||||||||||||||||
91708551|NCT00528372|183309971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.761||||||||||||||||
91708552|NCT00528372|183309971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|6.334||||||||||||||||
91708553|NCT00528372|183309971|SUPERIORITY_OR_OTHER||Percent difference from placebo|18.8|||||TWO_SIDED|95.0|5.5|32.1||||||||32.1|5.5|
91708554|NCT00528372|183309971|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.3|||||TWO_SIDED|95.0|-1.8|24.4||||||||24.4|-1.8|
91708555|NCT00528372|183309971|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.4|||||TWO_SIDED|95.0|-1.0|23.9||||||||23.9|-1.0|
91708556|NCT00528372|183309972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.736||||||||||||||||
91708557|NCT00528372|183309972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.7371||||||||||||||||
91647005|NCT00390949|183185653|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair and age-group||||||<0.05
91647006|NCT00390949|183185654|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
91647007|NCT00763269|183185663|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91708558|NCT00528372|183309972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.7078||||||||||||||||
91647008|NCT00763269|183185664|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91647009|NCT00763269|183185665|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91708559|NCT00528372|183309972|SUPERIORITY_OR_OTHER||Difference from placebo|-1.87|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
91708560|NCT00528372|183309972|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
91708561|NCT00528372|183309972|SUPERIORITY_OR_OTHER||Difference from placebo|-0.97|STANDARD_ERROR_OF_MEAN|0.7135||||95.0|-2.37|0.44||||||||0.44|-2.37|
91708562|NCT01289574|183309983|SUPERIORITY_OR_OTHER|||||||0.1919|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site||||||0.1919
91708563|NCT01289574|183309984|SUPERIORITY_OR_OTHER|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
91584613|NCT02647320|183059585|OTHER||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|9.28||0.873|TWO_SIDED|90.0|-13.835|16.815|||Mixed Model Repeated Measure|||Difference in change at week 4||16.815|-13.835|.873
91584614|NCT02647320|183059585|OTHER||LS Mean Difference|-8.09|STANDARD_ERROR_OF_MEAN|9.505||0.395|TWO_SIDED|90.0|-23.79|7.604|||Mixed Model Repeated Measure|||Difference in change at week 4||7.604|-23.790|.395
91584615|NCT02647320|183059585|OTHER||LS Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|8.306||0.761|TWO_SIDED|90.0|-16.247|11.185|||Mixed Model Repeated Measure|||Difference in change at week 4||11.185|-16.247|.761
91584616|NCT02647320|183059585|OTHER||LS Mean Difference|-27.73|STANDARD_ERROR_OF_MEAN|8.17|<|0.001|TWO_SIDED|90.0|-41.22|-14.236|||Mixed Model Repeated Measure|||Difference in change at week 4||-14.236|-41.220|<0.001
91584617|NCT02647320|183059586|OTHER||LS Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|12.001||0.527|TWO_SIDED|90.0|-27.441|12.221|||Mixed Model Repeated Measure|||Difference in change at week 12||12.221|-27.441|.527
91647010|NCT00763269|183185666|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91647011|NCT01398982|183185674|NON_INFERIORITY_OR_EQUIVALENCE|Based on our published prospective, nonrandomized study using TAP block in abdominally-based autologous tissue breast reconstruction, 40 patients per group would achieve 85% power to detect a 65% reduction in mean total opioid consumption between the control and study groups (significance level alpha = 0.05; using a two-sided Wilcoxon rank-sum test).||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
91647012|NCT02229487|183185688|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||||||0.209
91584618|NCT02647320|183059586|OTHER||LS Mean Difference|-7.39|STANDARD_ERROR_OF_MEAN|0.532||0.532|TWO_SIDED|90.0|-26.927|12.138|||Mixed Model Repeated Measure|||Difference in change at week 12||12.138|-26.927|.532
91584619|NCT02647320|183059586|OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|10.421||0.672|TWO_SIDED|90.0|-21.635|12.807|||Mixed Model Repeated Measure|||Difference in change at week 12||12.807|-21.635|.672
91647013|NCT04936334|183185693|SUPERIORITY||McNemar|0.03|||<|0.05|TWO_SIDED||||||McNemar|||||||<0.05
91647014|NCT01347879|183185696|SUPERIORITY_OR_OTHER||Difference in least square means|-7.35||||0.006|TWO_SIDED|95.0|-12.5|-2.2|||ANCOVA|Lesion count at baseline and center as covariates||||-2.2|-12.5|0.006
91708564|NCT01289574|183309985|SUPERIORITY_OR_OTHER|||||||0.0857|||||||Cochran-Mantel-Haenszel|||||||0.0857
91647015|NCT01347879|183185697|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6||||0.8527|TWO_SIDED|95.0|-6.6|5.5|||ANCOVA|Lesion count at baseline and center as covariates||||5.5|-6.6|0.8527
91647016|NCT01347879|183185698|SUPERIORITY_OR_OTHER||Difference in least square means|-20.0||||0.0032|TWO_SIDED|95.0|-33.2|-6.8|||ANCOVA|Lesion count at baseline and center as covariates||||-6.8|-33.2|0.0032
91647017|NCT01347879|183185699|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Regression, Logistic|||||||0.0125
91647018|NCT01347879|183185704|SUPERIORITY_OR_OTHER||Difference in least square means|-2.56||||0.7161|TWO_SIDED|95.0|-16.5|11.3|||ANCOVA|Lesion count at baseline and center as covariate||||11.3|-16.5|0.7161
91584620|NCT02647320|183059586|OTHER||LS Mean Difference|-31.58|STANDARD_ERROR_OF_MEAN|10.229||0.002|TWO_SIDED|90.0|-48.482|-14.676|||Mixed Model Repeated Measure|||Difference in change at week 12||-14.676|-48.482|.002
91584621|NCT02647320|183059587|OTHER||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.9||0.298|TWO_SIDED|90.0|-15.9|3.6|||Mixed Model Repeated Measure|||Difference in change at week 2||3.60|-15.90|.298
91584622|NCT02647320|183059587|OTHER||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|6.09||0.008|TWO_SIDED|90.0|-26.37|-6.27|||Mixed Model Repeated Measure|||Difference in change at week 2||-6.27|-26.37|.008
91584623|NCT02647320|183059587|OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.32||0.074|TWO_SIDED|90.0|-18.31|-0.75|||Mixed Model Repeated Measure|||Difference in change at week 2||-0.75|-18.31|.074
91584624|NCT02647320|183059587|OTHER||LS Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|5.32|<|0.001|TWO_SIDED|90.0|-35.96|-18.38|||Mixed Model Repeated Measure|||Difference in change at week 2||-18.38|-35.96|<0.001
91584625|NCT02647320|183059588|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|5.96||0.84|TWO_SIDED|90.0|-11.04|8.63|||Mixed Model Repeated Measure|||Difference in change at week 4||8.63|-11.04|.840
91584626|NCT02647320|183059588|OTHER||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.06||0.05|TWO_SIDED|90.0|-21.94|-1.91|||Mixed Model Repeated Measure|||Difference in change at week 4||-1.91|-21.94|.050
91584627|NCT02647320|183059588|OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.31||0.227|TWO_SIDED|90.0|-15.21|2.33|||Mixed Model Repeated Measure|||Difference in change at week 4||2.33|-15.21|.227
91647019|NCT03747939|183185710|SUPERIORITY||Adjusted difference in proportions|18.5||||0.0008|TWO_SIDED|95.0|8.9|28.1|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per Interactive Web Response System (IWRS) data, using Cochran-Mantel-Haenszel (CMH) weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||28.1|8.9|0.0008
91647020|NCT03747939|183185711|SUPERIORITY||Adjusted difference in proportions|18.6||||0.0017|TWO_SIDED|95.0|7.0|30.2|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||30.2|7.0|0.0017
91708565|NCT02379273|183309986|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||A Friedman repeated-measures ANOVA on ranks was applied to the unilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.||||<0.001
91708566|NCT02379273|183309986|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
91708567|NCT02379273|183309987|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the unilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
91584628|NCT02647320|183059588|OTHER||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|5.27||0.13|TWO_SIDED|90.0|-21.83|-4.43|||Mixed Model Repeated Measure|||Difference in change at week 4||-4.43|-21.83|0.13
91584629|NCT02647320|183059589|OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|6.55||0.642|TWO_SIDED|90.0|-7.77|13.88|||Mixed Model Repeated Measure|||Difference in change at week 8||13.88|-7.77|.642
91584630|NCT02647320|183059589|OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.72||0.512|TWO_SIDED|90.0|-15.52|6.68|||Mixed Model Repeated Measure|||Difference in change at week 8||6.68|-15.52|.512
91584631|NCT02647320|183059589|OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.81||0.486|TWO_SIDED|90.0|-13.66|5.54|||Mixed Model Repeated Measure|||Difference in change at week 8||5.54|-13.66|.486
91584632|NCT02647320|183059589|OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|5.8||0.004|TWO_SIDED|90.0|-26.31|-7.16|||Mixed Model Repeated Measure|||Difference in change at week 8||-7.16|-26.31|.004
91584633|NCT02647320|183059590|OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|8.11||0.285|TWO_SIDED|90.0|-22.09|4.7|||Mixed Model Repeated Measure|||Difference in change at week 12||4.70|-22.09|.285
91584634|NCT02647320|183059590|OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|7.94||0.02|TWO_SIDED|90.0|-31.73|-5.49|||Mixed Model Repeated Measure|||Difference in change at week 12||-5.49|-31.73|.020
91584635|NCT02647320|183059590|OTHER||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|7.03||0.067|TWO_SIDED|90.0|-24.6|-1.35|||Mixed Model Repeated Measure|||Difference in change at week 12||-1.35|-24.60|.067
91584636|NCT02647320|183059590|OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.88||0.012|TWO_SIDED|90.0|-28.76|-6.03|||Mixed Model Repeated Measure|||Difference in change at week 12||-6.03|-28.76|.012
91584637|NCT00081770|183059592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.567||95.0|0.79|1.14||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.14|0.79|0.567
91584638|NCT00081770|183059592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.195||95.0|0.9|1.3||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.30|0.90|0.195
91708568|NCT02379273|183309987|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
91584639|NCT00081770|183059594|SUPERIORITY_OR_OTHER||Percentage of participants|39.9||||||95.0|36.9|42.9|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||42.9|36.9|
91584640|NCT00081770|183059594|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|33.1|39.0|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||39.0|33.1|
91584641|NCT00081770|183059594|SUPERIORITY_OR_OTHER||Percentage of participants|45.0||||||95.0|42.0|48.1|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||48.1|42.0|
91647021|NCT03747939|183185712|SUPERIORITY||Adjusted difference in proportions|5.1||||0.3539|TWO_SIDED|95.0|-5.8|16.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||16.0|-5.8|0.3539
91584642|NCT01072877|183059596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.49|||=|0.0001|TWO_SIDED|95.0|-3.72|-1.27|||ANCOVA|||||-1.27|-3.72|=0.0001
91708569|NCT02379273|183309988|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
91584643|NCT01072877|183059596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54|||<|0.0001|TWO_SIDED|95.0|-4.8|-2.29|||ANCOVA|||||-2.29|-4.80|<0.0001
91584644|NCT01072877|183059596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.98|-1.48|||ANCOVA|||||-1.48|-3.98|<0.0001
91584645|NCT01072877|183059596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.65|||<|0.0001|TWO_SIDED|95.0|-4.84|-2.46|||ANCOVA|||||-2.46|-4.84|<0.0001
91584646|NCT01072877|183059597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||=|0.0001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||||-0.40|-1.17|=0.0001
91584647|NCT01072877|183059597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.65|-0.86|||ANCOVA|||||-0.86|-1.65|<0.0001
91584648|NCT01072877|183059597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.06|||ANCOVA|||||-1.06|-1.85|<0.0001
91584649|NCT01072877|183059597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.23|||ANCOVA|||||-1.23|-1.98|<0.0001
91584650|NCT01072877|183059598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.0001|TWO_SIDED|95.0|-0.66|-0.23|||ANCOVA|||||-0.23|-0.66|=0.0001
91584651|NCT01072877|183059598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|||||-0.53|-0.98|<0.0001
91584652|NCT01072877|183059598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.53|||ANCOVA|||||-0.53|-0.97|<0.0001
91584653|NCT01072877|183059598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.68|||ANCOVA|||||-0.68|-1.11|<0.0001
91584654|NCT00601419|183059601|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of treatment related adverse events."||||=0.556
91584655|NCT00601419|183059602|SUPERIORITY_OR_OTHER||||||=|0.845|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.845
91584656|NCT00601419|183059603|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Fisher Exact|||"The null hypothesis is that there is no difference between With TSH deficiency and Without TSH deficiency in the frequency of treatment related adverse events."||||=0.038
91584657|NCT00601419|183059604|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past history. The null hypothesis is that there is no difference between With past history and Without past history in the frequency of treatment related adverse events."||||=0.013
91584658|NCT00601419|183059605|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no association between Initial Dose and the frequency of treatment related adverse events."||||=0.037
91584659|NCT00601419|183059605|SUPERIORITY_OR_OTHER||||||=|0.063|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose."||||=0.063
91584660|NCT00601419|183059607|SUPERIORITY_OR_OTHER||||||=|0.019|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years of age and \>=65 years of age in the efficacy of somatropin."||||=0.019
91584661|NCT00601419|183059608|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between male and female in the efficacy of somatropin."||||=1.000
91584662|NCT00601419|183059609|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was ACTH deficiency. The null hypothesis is that there is no difference between With ACTH deficiency and Without ACTH deficiency in the efficacy of somatropin."||||=0.037
91584663|NCT00362453|183059614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.8||||0.0005|TWO_SIDED|95.0|-183.66|-53.94|||Mixed Models Analysis|||||-53.94|-183.66|0.0005
91584664|NCT00362453|183059615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-324.6||||0.001|TWO_SIDED|95.0|-513.98|-135.22|||Mixed Models Analysis|||12 Week||-135.22|-513.98|0.001
91584665|NCT00362453|183059615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.2||||0.06|TWO_SIDED|95.0|-372.58|6.18|||Mixed Models Analysis|||24 Week||6.18|-372.58|0.06
91584666|NCT00362453|183059615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-105.3||||0.3|TWO_SIDED|95.0|-294.68|84.08|||Mixed Models Analysis|||48 week||84.08|-294.68|0.3
91584667|NCT00362453|183059616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.9||||0.1|TWO_SIDED|95.0|-53.04|7.24|||Mixed Models Analysis|||12 week||7.24|-53.04|0.1
91584668|NCT00362453|183059616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8||||0.3|TWO_SIDED|95.0|-44.94|15.34|||Mixed Models Analysis|||24 week||15.34|-44.94|0.3
91584669|NCT00362453|183059616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.8|TWO_SIDED|95.0|-33.79|26.49|||Mixed Models Analysis|||48 Week||26.49|-33.79|0.8
91584670|NCT00362453|183059617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.95||||0.05|TWO_SIDED|95.0|-131.81|-2.09|||Mixed Models Analysis|||24 Week||-2.09|-131.81|0.05
91584671|NCT00362453|183059617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.15||||0.2|TWO_SIDED|95.0|-111.01|18.71|||Mixed Models Analysis|||48 Week||18.71|-111.01|0.2
91584672|NCT00362453|183059618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.01|TWO_SIDED|95.0|-3.82|-0.49|||Mixed Models Analysis|||12 Week||-0.49|-3.82|0.01
91584673|NCT00362453|183059618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4|TWO_SIDED|95.0|-2.31|1.02|||Mixed Models Analysis|||24 Week||1.02|-2.31|0.4
91584674|NCT00362453|183059618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-1.62|1.7|||Mixed Models Analysis|||48 weeks||1.70|-1.62|1.0
91584675|NCT00362453|183059619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|95.0|-2.75|-0.66|||Mixed Models Analysis|||12 Week||-0.66|-2.75|0.002
91584676|NCT00362453|183059619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.3|TWO_SIDED|95.0|-1.58|0.51|||Mixed Models Analysis|||24 Week||0.51|-1.58|0.3
91584677|NCT00362453|183059619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.06|TWO_SIDED|95.0|-2.09|0.02|||Mixed Models Analysis|||48 Week||0.02|-2.09|0.06
91584678|NCT00362453|183059620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.88||||5e-05|TWO_SIDED|95.0|-15.91|-5.84|||Mixed Models Analysis|||12 Week||-5.84|-15.91|0.00005
91584679|NCT00362453|183059620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.05|TWO_SIDED|95.0|-10.15|-0.08|||Mixed Models Analysis|||24 Week||-0.08|-10.15|0.05
91584680|NCT00362453|183059620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.02|TWO_SIDED|95.0|-11.06|-0.91|||Mixed Models Analysis|||48 Week||-0.91|-11.06|0.02
91584681|NCT00362453|183059621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.08||||0.1|TWO_SIDED|95.0|-10.34|110.5|||Mixed Models Analysis|||12 Week||110.50|-10.34|0.1
91584682|NCT00362453|183059621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.71||||0.1|TWO_SIDED|95.0|-15.07|102.5|||Mixed Models Analysis|||24 Week||102.50|-15.07|0.1
91584683|NCT00362453|183059621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.61||||0.7|TWO_SIDED|95.0|-49.36|78.59|||Mixed Models Analysis|||48 Weeks||78.59|-49.36|0.7
91584684|NCT00362453|183059622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.54|0.34|||Mixed Models Analysis|||12 Weeks||0.34|-0.54|0.7
91584685|NCT00362453|183059622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.7|TWO_SIDED|95.0|-0.37|0.52|||Mixed Models Analysis|||24 Weeks||0.52|-0.37|0.7
91584686|NCT00362453|183059622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.6|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||48 weeks||0.34|-0.55|0.6
91584687|NCT00362453|183059623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.009|TWO_SIDED|95.0|-11.63|-1.77|||Mixed Models Analysis|||12 Week||-1.77|-11.63|0.009
91708570|NCT02379273|183309989|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||<0.001
91584688|NCT00362453|183059623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.04|TWO_SIDED|95.0|-10.23|-0.37|||Mixed Models Analysis|||24 Weeks||-0.37|-10.23|0.04
91584689|NCT00362453|183059623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.0006|TWO_SIDED|95.0|-13.83|-3.97|||Mixed Models Analysis|||48 Week||-3.97|-13.83|0.0006
91584690|NCT00362453|183059624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.04|TWO_SIDED|95.0|0.03|1.39|||Mixed Models Analysis|||12 Weeks||1.39|0.03|0.04
91584691|NCT00362453|183059624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.02|TWO_SIDED|95.0|0.17|1.53|||Mixed Models Analysis|||24 Weeks||1.53|0.17|0.02
91584692|NCT00362453|183059624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.007|TWO_SIDED|95.0|0.28|1.64|||Mixed Models Analysis|||48 Weeks||1.64|0.28|0.007
91708571|NCT02379273|183309990|SUPERIORITY|Pre- and postoperative mean scores were compared based on Friedman repeated-measures analysis of variance with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
91778361|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4647|TWO_SIDED|95.0|0.84|1.48|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.48|0.84|0.4647
91778362|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7676|TWO_SIDED|95.0|0.78|1.4|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.40|0.78|0.7676
91778363|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.1983|TWO_SIDED|95.0|0.89|1.71|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.71|0.89|0.1983
91778364|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9874|TWO_SIDED|95.0|0.69|1.44|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.44|0.69|0.9874
91584693|NCT00362453|183059625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43||||0.004|TWO_SIDED|95.0|2.5|12.36|||Mixed Models Analysis|||12 Weeks||12.36|2.50|0.004
91584694|NCT00362453|183059625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51||||0.08|TWO_SIDED|95.0|-0.42|9.45|||Mixed Models Analysis|||24 Weeks||9.45|-0.42|0.08
91584695|NCT00362453|183059625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32||||0.01|TWO_SIDED|95.0|1.38|11.25|||Mixed Models Analysis|||48 Weeks||11.25|1.38|0.01
91584696|NCT00362453|183059626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.9|TWO_SIDED|95.0|-6.15|6.57|||Mixed Models Analysis|||12 Weeks||6.57|-6.15|0.9
91584697|NCT00362453|183059626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1|TWO_SIDED|95.0|-6.47|6.25|||Mixed Models Analysis|||24 Weeks||6.25|-6.47|1.0
91584698|NCT00362453|183059626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.77||||0.1|TWO_SIDED|95.0|-1.59|11.13|||Mixed Models Analysis|||48 Weeks||11.13|-1.59|0.10
91778365|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.4716|TWO_SIDED|95.0|0.58|1.29|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.29|0.58|0.4716
91778366|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2041|TWO_SIDED|95.0|0.46|1.18|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.18|0.46|0.2041
91778367|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7771|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.45|0.76|0.7771
91778368|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8542|TWO_SIDED|95.0|0.64|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.45|0.64|0.8542
91778369|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.5||||0.123|TWO_SIDED|95.0|0.9|2.5|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||2.50|0.90|0.1230
91778370|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.72||||0.1089|TWO_SIDED|95.0|0.88|3.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||3.34|0.88|0.1089
91778371|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|5.82||||0.0011|TWO_SIDED|95.0|1.85|18.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||18.30|1.85|0.0011
91778372|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.51||||0.295|TWO_SIDED|95.0|0.43|14.74|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||14.74|0.43|0.2950
91778373|NCT03038100|183438016|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33|||||TWO_SIDED|95.0|-37.72|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-37.72|
91521165|NCT02954354|182917028|SUPERIORITY|||||||0.2424||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.2424
91584699|NCT02382016|183059716|SUPERIORITY||ratio of geometric means|0.65||||0.0001|TWO_SIDED|95.0|0.59|0.72|||ANCOVA|ANCOVA model adjusted by treatment, background PAH-specific therapy at baseline and region as factors \& log-transformed PVR at baseline as a covariate||The null hypothesis (change of PVR at Week 12 as a ratio of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed ratio of PVR at Week 12 to baseline PVR.||0.72|0.59|0.0001
91584700|NCT02382016|183059717|SUPERIORITY||Least squares (LS) mean difference|9.73||||0.4264|TWO_SIDED|95.0|-14.5|33.95||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|mixed-effect model repeated measure||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in 6MWD (LS mean difference macitentan 10 mg - placebo).|The main analysis on 6MWD was performed using a mixed-effect model repeated measure (MMRM) adjusted for treatment, visit, region, PAH-specific therapy at baseline, and treatment-by-visit interaction as factors, and baseline 6MWD and WHO functional class (FC) as covariates.||33.95|-14.50|0.4264
91584701|NCT02382016|183059718|SUPERIORITY||Odds Ratio (OR)|6.253||||0.1278|TWO_SIDED|95.0|0.714|298.376||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|Regression, Logistic|||A logistic regression model (exact) adjusted for treatment, PAH-specific therapy at baseline, and region as covariates was used to analyze worsening in WHO FC.||298.376|0.714|0.1278
91584702|NCT02382016|183059719|SUPERIORITY||ratio of geometric means|0.874||||0.3951|TWO_SIDED|95.0|0.639|1.196||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA|||||1.196|0.639|0.3951
91584703|NCT02382016|183059720|SUPERIORITY||Least squares (LS) mean difference|1.67||||0.0637|TWO_SIDED|95.0|-0.1|3.44||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mRAP (LS mean difference macitentan 10 mg - placebo).|||3.44|-0.10|0.0637
91584704|NCT02382016|183059721|SUPERIORITY||Least squares (LS) mean difference|-5.99||||0.0001|TWO_SIDED|95.0|-8.4|-3.57||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mPAP (LS mean difference macitentan 10 mg - placebo).|||-3.57|-8.40|0.0001
91584705|NCT02382016|183059722|SUPERIORITY||Least squares (LS) mean difference|0.52||||0.0009|TWO_SIDED|95.0|0.22|0.81||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in cardiac index (LS mean difference macitentan 10 mg - placebo).|||0.81|0.22|0.0009
91647022|NCT03747939|183185713|SUPERIORITY||Adjusted difference in proportions|22.1||||0.0003|TWO_SIDED|95.0|10.4|33.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||33.7|10.4|0.0003
91708572|NCT02432144|183309992|SUPERIORITY||LS Mean|-62.28|STANDARD_ERROR_OF_MEAN|4.946|<|0.0001|TWO_SIDED|95.0|-71.98|-52.59||P-values are from generalized estimating equation (GEE) model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 0||-52.59|-71.98|< 0.0001
91708573|NCT02432144|183309992|SUPERIORITY||LS Mean|-67.18|STANDARD_ERROR_OF_MEAN|3.224|<|0.0001|TWO_SIDED|95.0|-73.49|-60.86||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 12||-60.86|-73.49|< 0.0001
91708574|NCT02432144|183309992|SUPERIORITY||LS Mean|-64.12|STANDARD_ERROR_OF_MEAN|4.016|<|0.0001|TWO_SIDED|95.0|-71.99|-56.24||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 24||-56.24|-71.99|< 0.0001
91778374|NCT01774721|183438033|SUPERIORITY||Hazard Ratio (HR)|0.589|||<|0.0001|TWO_SIDED|95.0|0.469|0.739|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.739|0.469|<0.0001
91708575|NCT02432144|183309992|SUPERIORITY||LS Mean|-60.8|STANDARD_ERROR_OF_MEAN|5.992|<|0.0001|TWO_SIDED|95.0|-72.54|-49.06||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 36||-49.06|-72.54|< 0.0001
91708576|NCT02432144|183309992|SUPERIORITY||LS Mean|-57.85|||<|0.0001|TWO_SIDED|95.0|-71.87|-43.82||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 48||-43.82|-71.87|< 0.0001
91708577|NCT02371668|183310041|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91708578|NCT02371668|183310042|SUPERIORITY|||||||0.114|||||||Fisher Exact|||||||0.114
91708579|NCT02371668|183310043|SUPERIORITY|||||||0.4989|||||||Wilcoxon (Mann-Whitney)|||||||0.4989
91708580|NCT02371668|183310044|SUPERIORITY|||||||0.1412|||||||Wilcoxon (Mann-Whitney)|||||||0.1412
91708581|NCT02371668|183310045|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
91708582|NCT02371668|183310046|SUPERIORITY|||||||0.2445|||||||Wilcoxon (Mann-Whitney)|||||||0.2445
91708583|NCT02371668|183310047|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
91708584|NCT02371668|183310048|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.230
91778375|NCT01774721|183438034|SUPERIORITY||Hazard Ratio (HR)|0.748||||0.0077|TWO_SIDED|95.0|0.591|0.947|||1-sided stratified log-rank test||Based on stratified Cox Regression model|||0.947|0.591|0.0077
91584706|NCT02382016|183059723|SUPERIORITY||Least squares (LS) mean difference|-171.48||||0.0001|TWO_SIDED|95.0|-223.67|-119.3||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in TPR (LS mean difference macitentan 10 mg - placebo).|||-119.30|-223.67|0.0001
91584707|NCT02382016|183059724|SUPERIORITY||Least squares (LS) mean difference|0.03||||0.9844|TWO_SIDED|95.0|-2.85|2.91||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in SVO2 (LS mean difference macitentan 10 mg - placebo).|||2.91|-2.85|0.9844
91584708|NCT01535014|183059725|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
91584709|NCT01535014|183059725|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91584710|NCT01535014|183059725|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|||||||0.0007
91584711|NCT01535014|183059726|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91584712|NCT01535014|183059726|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91584713|NCT01535014|183059727|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91584714|NCT01535014|183059727|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91584715|NCT01535014|183059728|SUPERIORITY||||||<|0.05||||||For week 12, 16, 20, 24|Chi-squared|||||||<0.05
91584716|NCT01535014|183059728|SUPERIORITY||||||<|0.05||||||For week 16, 20, 24|Chi-squared|||||||<0.05
91584717|NCT01535014|183059729|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
91584718|NCT01535014|183059729|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
91584719|NCT01535014|183059730|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
91584720|NCT01535014|183059730|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
91584721|NCT01535014|183059731|SUPERIORITY|||||||0.02|||||||ANCOVA|||SF-36 Mental Health Domain||||0.02
91584722|NCT01535014|183059731|SUPERIORITY|||||||0.63|||||||ANCOVA|||SF-36 Mental Health Domain||||0.63
91584723|NCT01535014|183059731|SUPERIORITY|||||||0.6|||||||ANCOVA|||SF-36 Physical Health Domain||||0.60
91584724|NCT01535014|183059731|SUPERIORITY|||||||0.98|||||||ANCOVA|||SF-36 Physical Health Domain||||0.98
91584725|NCT00719563|183059768|SUPERIORITY_OR_OTHER|||||||0.0737|||||||Wilcoxon Rank Sum|||||||0.0737
91584726|NCT02047643|183059781|OTHER|||||||0.45|||||||Fisher Exact|Two-sided Fisher Exact test||||||.45
91584727|NCT02047643|183059782|OTHER|||||||0.66|||||||Fisher Exact|Two-sided Fisher Exact test||||||.66
91584728|NCT04256603|183059783|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||wilcox two sample test||||0.67
91584729|NCT02113241|183059788|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
91584730|NCT02113241|183059788|SUPERIORITY|||||||0.089||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.089
91708585|NCT02371668|183310049|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
91708586|NCT00398216|183310050|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
91708587|NCT00398216|183310050|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91708588|NCT00398216|183310050|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91708589|NCT00398216|183310050|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91708590|NCT00398216|183310053|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||||||.250
91584731|NCT02113241|183059789|SUPERIORITY|||||||0.003||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.003
91584732|NCT02113241|183059789|SUPERIORITY|||||||0.248||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.248
91584733|NCT02113241|183059790|SUPERIORITY|||||||0.161||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.161
91584734|NCT02113241|183059790|SUPERIORITY|||||||0.079||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.079
91584735|NCT02113241|183059791|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.067
91584736|NCT02113241|183059791|SUPERIORITY|||||||0.918||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.918
91584737|NCT02113241|183059792|SUPERIORITY|||||||0.128||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.128
91584738|NCT02113241|183059792|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
91584739|NCT02113241|183059793|SUPERIORITY|||||||0.433|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.433
91584740|NCT02113241|183059793|SUPERIORITY|||||||0.407||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.407
91584741|NCT02113241|183059794|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
91584742|NCT02113241|183059794|SUPERIORITY|||||||0.826||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.826
91584743|NCT02113241|183059795|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.791
91584744|NCT02113241|183059795|SUPERIORITY|||||||0.413||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.413
91584745|NCT02113241|183059796|SUPERIORITY|||||||0.075||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.075
91584746|NCT02113241|183059796|SUPERIORITY|||||||0.432||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.432
91708591|NCT00398216|183310053|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Fisher Exact|||||||.122
91647023|NCT03747939|183185714|SUPERIORITY||Adjusted difference in proportions|11.8||||0.0286|TWO_SIDED|95.0|1.7|22.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||22.0|1.7|0.0286
91647024|NCT03747939|183185715|SUPERIORITY||Adjusted difference in proportions|16.3||||0.0022|TWO_SIDED|95.0|6.9|25.8|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||25.8|6.9|0.0022
91647025|NCT03747939|183185716|SUPERIORITY||Difference in LS means|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.59|||MMRM||Apremilast - Placebo|Difference in LS means is based MMRM of the change from baseline.||-0.59|-1.48|<0.0001
91647026|NCT03747939|183185717|SUPERIORITY||Adjusted difference in proportions|17.7||||0.0043|TWO_SIDED|95.0|5.7|29.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||29.7|5.7|0.0043
91647027|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.64||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.64|-0.94|<0.0001
91647028|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.76|-1.06|<0.0001
91647029|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.52||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.52|-0.82|<0.0001
91647030|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1245|TWO_SIDED|95.0|-0.27|0.03||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||0.03|-0.27|0.1245
91647031|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0022|TWO_SIDED|95.0|-0.39|-0.09||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.09|-0.39|0.0022
91647032|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.41|-0.79|<0.0001
91647033|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.49||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.49|-0.87|<0.0001
91647034|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.48||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.48|-0.75|<0.0001
91647035|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.83|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.83|<0.0001
91647036|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.89|-0.59||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.59|-0.89|<0.0001
91647037|NCT01289990|183185755|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.85|<0.0001
91647038|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.61|-1.04|<0.0001
91647039|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.11|-0.69||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.69|-1.11|<0.0001
91647040|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.0322|TWO_SIDED|95.0|-0.41|-0.02||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.02|-0.41|0.0322
91647041|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0038|TWO_SIDED|95.0|-0.48|-0.09||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.09|-0.48|0.0038
91584747|NCT02113241|183059797|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
91584748|NCT02113241|183059797|SUPERIORITY|||||||0.835||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.835
91584749|NCT02113241|183059798|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
91584750|NCT02113241|183059798|SUPERIORITY|||||||0.778||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.778
91584751|NCT02113241|183059799|SUPERIORITY|||||||0.338||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.338
91584752|NCT02113241|183059799|SUPERIORITY|||||||0.309||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.309
91584753|NCT02113241|183059800|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.049
91584754|NCT02113241|183059800|SUPERIORITY|||||||0.563||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.563
91647042|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.83|-0.4||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.40|-0.83|<0.0001
91778376|NCT01774721|183438036|SUPERIORITY||Hazard Ratio (HR)|0.622|||<|0.0001|TWO_SIDED|95.0|0.497|0.779|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.779|0.497|<0.0001
91584755|NCT02113241|183059801|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.850
91584756|NCT02113241|183059801|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.206
91584757|NCT02113241|183059802|SUPERIORITY|||||||0.006||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.006
91584758|NCT02113241|183059802|SUPERIORITY|||||||0.95||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.950
91584759|NCT02113241|183059803|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.011
91647043|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.33|-0.90|<0.0001
91584760|NCT02113241|183059803|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
91584761|NCT02113241|183059804|SUPERIORITY|||||||0.652||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.652
91584762|NCT02113241|183059804|SUPERIORITY|||||||0.055||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.055
91584763|NCT02113241|183059805|SUPERIORITY|||||||0.254||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.254
91584764|NCT02113241|183059805|SUPERIORITY|||||||0.787||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.787
91584765|NCT02113241|183059806|SUPERIORITY|||||||0.129||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.129
91584766|NCT02113241|183059806|SUPERIORITY|||||||0.365||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.365
91584767|NCT02113241|183059807|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
91584768|NCT02113241|183059807|SUPERIORITY|||||||0.175||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.175
91584769|NCT02113241|183059808|SUPERIORITY|||||||0.392||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.392
91584770|NCT02113241|183059808|SUPERIORITY|||||||0.123|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.123
91584771|NCT02113241|183059809|SUPERIORITY|||||||0.176||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.176
91584772|NCT02113241|183059809|SUPERIORITY|||||||0.268||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.268
91584773|NCT02113241|183059810|SUPERIORITY|||||||0.064||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.064
91584774|NCT02113241|183059810|SUPERIORITY|||||||0.462||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.462
91647044|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.0|-0.44||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.44|-1.00|<0.0001
91708592|NCT00398216|183310053|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Fisher Exact|||||||.124
91778377|NCT01774721|183438039|SUPERIORITY||Hazard Ratio (HR)|0.403|||<|0.0001|TWO_SIDED|95.0|0.307|0.529|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on IRC review||0.529|0.307|<0.0001
91584775|NCT02113241|183059811|SUPERIORITY|||||||0.346||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.346
91584776|NCT02113241|183059811|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.002
91584777|NCT03249714|183059817|SUPERIORITY||Rate ratio|0.064|||<|0.001|TWO_SIDED|95.0|0.018|0.232|||negative binominal regression model|||||0.232|0.018|<0.001
91584778|NCT03249714|183059818|SUPERIORITY||rate ratio|0.136||||0.003|TWO_SIDED|95.0|0.036|0.513||Statistical significance (2-sided) at the 0.05 level|negative binomial regression|||||0.513|0.036|0.003
91584779|NCT03249714|183059818|SUPERIORITY||rate ratio|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||negative binominal regression|Indicates statistical significance (2-sided) at the 0.05 level.||||0.000|0.000|< 0.001
91584780|NCT03249714|183059819|SUPERIORITY||Rate ratio|0.284||||0.002|TWO_SIDED|95.0|0.13|0.62|||negative binominal regression|||||0.620|0.130|0.002
91584781|NCT03249714|183059820|SUPERIORITY||Rate ratio|0.42||||0.119|TWO_SIDED|95.0|0.141|1.25|||negative binominal regression|||||1.250|0.141|0.119
91584782|NCT01996813|183059829|SUPERIORITY||Odds Ratio (OR)|0.115||||0.0553|TWO_SIDED|95.0|0.002|1.034||The exact p-value was estimated|Regression, Logistic|The method was exact logistic regression||The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||1.034|0.002|.0553
91584783|NCT01996813|183059830|SUPERIORITY||Mean Difference (Final Values)|40.31|||<|0.001|TWO_SIDED|95.0|20.22|60.39|||t-test, 2 sided|A Satterthwaite correction was used to adjust the degrees of freedom||The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||60.39|20.22|<.001
91647045|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.47||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.47|-0.87|<0.0001
91647046|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.04|-0.63||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.63|-1.04|<0.0001
91584784|NCT00879762|183059831|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.398|0.868|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.868|0.398|
91584785|NCT00879762|183059832|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.384|0.853|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.853|0.384|
91708593|NCT00398216|183310053|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||Fisher Exact|||||||.123
91584786|NCT00879762|183059838|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.2|0.97|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||0.97|-0.20|
91584787|NCT00879762|183059839|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-0.17|1.0|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||1.00|-0.17|
91584788|NCT01211197|183059914|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.59|STANDARD_DEVIATION|7.6|||TWO_SIDED|90.0|95.75|105.67|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Ratio calculated as FDC fasted divided by individual tablets fasted.||105.67|95.75|
91584789|NCT01211197|183059914|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.94|STANDARD_DEVIATION|8.0|||TWO_SIDED|90.0|89.85|100.33|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||100.33|89.85|
91647047|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.57||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.57|-1.04|<0.0001
91708594|NCT01048944|183310054|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values are adjusted for multiple comparisons except for specific a priori directional predictions.|Mixed Models Analysis|||Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).||||<0.05
91708595|NCT01133704|183310062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.719|TWO_SIDED|95.0|0.69|1.7|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)|||1.70|0.69|0.719
91647048|NCT01289990|183185756|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.56||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.56|-1.04|<0.0001
91647049|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.8|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.8|<0.0001
91647050|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0001|TWO_SIDED|95.0|-6.4|-2.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.1|-6.4|0.0001
91647051|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.2107|TWO_SIDED|95.0|-3.5|0.8||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.8|-3.5|0.2107
91647052|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.1||0.0033|TWO_SIDED|95.0|-5.4|-1.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.1|-5.4|0.0033
91647053|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.0105|TWO_SIDED|95.0|-5.0|-0.7||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-5.0|0.0105
91647054|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.0543|TWO_SIDED|95.0|-4.9|0.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-4.9|0.0543
91647055|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.2||0.0019|TWO_SIDED|95.0|-6.4|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-6.4|0.0019
91647056|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.0045|TWO_SIDED|95.0|-5.0|-0.9||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-5.0|0.0045
91647057|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.6|<0.0001
91647058|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.0031|TWO_SIDED|95.0|-4.8|-1.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-4.8|0.0031
91647059|NCT01289990|183185757|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.0||0.0096|TWO_SIDED|95.0|-4.4|-0.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-4.4|0.0096
91647060|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.63||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.63|-0.94|<0.0001
91647061|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.04|-0.73||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.73|-1.04|<0.0001
91647062|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.51||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.51|-0.82|<0.0001
91647063|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.131|TWO_SIDED|95.0|-0.28|0.04||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||0.04|-0.28|0.1310
91647064|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.07|-0.38|0.0050
91647065|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.4||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.40|-0.79|<0.0001
91647066|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.5||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.50|-0.88|<0.0001
91647067|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.46||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.46|-0.75|<0.0001
91647068|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.88|-0.58||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.58|-0.88|<0.0001
91647069|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.56|||ANCOVA|||||-0.56|-0.87|<0.0001
91647070|NCT01289990|183185758|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.53||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.53|-0.85|<0.0001
91647071|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0025|TWO_SIDED|95.0|-5.5|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.5|0.0025
91647072|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0021|TWO_SIDED|95.0|-5.6|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.6|0.0021
91647073|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.7241|TWO_SIDED|95.0|-1.8|2.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||2.6|-1.8|0.7241
91647074|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-5.9|0.0008
91647075|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.1||0.0007|TWO_SIDED|95.0|-6.0|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-6.0|0.0007
91647076|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.0987|TWO_SIDED|95.0|-4.5|0.4||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-4.5|0.0987
91647077|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2||0.0028|TWO_SIDED|95.0|-6.1|-1.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.3|-6.1|0.0028
91647078|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.6|-2.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.3|-6.6|<0.0001
91647079|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-5.9|0.0008
91647080|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|1.0||0.0213|TWO_SIDED|95.0|-4.1|-0.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-4.1|0.0213
91647081|NCT01289990|183185759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0288|TWO_SIDED|95.0|-4.1|-0.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-4.1|0.0288
91647082|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1058|TWO_SIDED|95.0|-2.4|0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-2.4|0.1058
91647083|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0109|TWO_SIDED|95.0|-3.1|-0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-3.1|0.0109
91584790|NCT01211197|183059915|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|99.31|STANDARD_DEVIATION|12.2|||TWO_SIDED|90.0|91.76|107.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||107.49|91.76|
91584791|NCT01211197|183059915|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|64.3|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|55.97|73.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||73.87|55.97|
91584792|NCT01211197|183059916|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.94|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|96.03|106.11|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||106.11|96.03|
91584793|NCT01211197|183059916|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.39|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|89.22|99.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||99.87|89.22|
91584794|NCT01211197|183059917|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.13|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|95.59|111.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.25|95.59|
91584795|NCT01211197|183059917|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|96.96|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.23|107.78|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||107.78|87.23|
91584796|NCT01211197|183059918|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|102.15|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|93.87|111.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.15|93.87|
91584797|NCT01211197|183059918|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.67|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|91.7|110.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||110.51|91.70|
91584798|NCT01211197|183059919|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.49|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|95.3|112.39|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||112.39|95.30|
91584799|NCT01211197|183059919|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|75.13|STANDARD_DEVIATION|24.5|||TWO_SIDED|90.0|63.68|88.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||88.64|63.68|
91584800|NCT01209780|183059945|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0||||||Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain||2|-4|
91584801|NCT01209780|183059945|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|10.0|||||TWO_SIDED|95.0|6.0|14.0||||||Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain||14|6|
91521166|NCT02954354|182917029|SUPERIORITY||Difference|-72.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-48.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-48.0|-72.0|<0.0001
91584802|NCT01209780|183059945|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-5.0|3.0||||||Non-inferiority of investigational TIV to the control TIV against B influenza strain||3|-5|
91584803|NCT01209780|183059947|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.11|1.56||||||Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain||1.56|1.11|
91584804|NCT01209780|183059947|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.34|1.64||||||Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain||1.64|1.34|
91647084|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.8259|TWO_SIDED|95.0|-1.5|1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.2|-1.5|0.8259
91584805|NCT01209780|183059947|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.07||||||Non-inferiority of investigational TIV to licensed control TIV against B influenza strain||1.07|0.85|
91584806|NCT05007808|183059957|SUPERIORITY|ANCOVA model with Change from Baseline to Week 4/EOT as the outcome (dependent) variable, treatment as the independent variable, and baseline score as covariate. The p-value was derived from the t-test for the comparison of adjusted LS means between the treatment groups.|LS Mean Difference|-0.19||||0.6742|TWO_SIDED|95.0|-1.081|0.701|||t-test, 2 sided|||||0.701|-1.081|0.6742
91584807|NCT02318797|183059980|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment by time interaction test||||<0.0001
91584808|NCT02318797|183059980|SUPERIORITY|||||||0.0019|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.0019
91584809|NCT02318797|183059981|SUPERIORITY|||||||0.4103|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4103
91584810|NCT02318797|183059981|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
91584811|NCT02318797|183059981|SUPERIORITY|||||||0.4068|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4068
91584812|NCT02318797|183059981|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.2656
91584813|NCT02318797|183059982|SUPERIORITY|||||||0.4582|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4582
91584814|NCT02318797|183059982|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
91584815|NCT02318797|183059982|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.05
91647085|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.166|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1660
91647086|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0212|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0212
91647087|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0076
91647088|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.7||0.0003|TWO_SIDED|95.0|-4.1|-1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-4.1|0.0003
91708596|NCT01133704|183310063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.331|TWO_SIDED|95.0|0.78|2.07|||Log Rank||Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).|||2.07|0.78|0.331
91584816|NCT02318797|183059982|SUPERIORITY|||||||0.1792|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.1792
91584817|NCT02318797|183059983|SUPERIORITY|||||||0.2179|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.2179
91584818|NCT02318797|183059983|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
91584819|NCT02318797|183059983|SUPERIORITY|||||||0.4797|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4797
91584820|NCT02318797|183059983|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.0014
91584821|NCT02318797|183059984|SUPERIORITY|||||||0.0058|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0058
91647089|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.017|TWO_SIDED|95.0|-3.2|-0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-3.2|0.0170
91708597|NCT02207400|183310064|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.612|||<|0.0001|TWO_SIDED|95.0|-13.191|-10.033|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-10.033|-13.191|<0.0001
91584822|NCT02318797|183059985|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0014
91584823|NCT02318797|183059986|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0001
91584824|NCT02318797|183059987|SUPERIORITY|||||||0.5566|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.5566
91584825|NCT02318797|183059987|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
91584826|NCT02318797|183059988|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.002
91584827|NCT02318797|183059989|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0029
91584828|NCT02318797|183059990|SUPERIORITY|||||||0.0021|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0021
91584829|NCT02318797|183059991|SUPERIORITY|||||||0.1183|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1183
91584830|NCT02318797|183059991|SUPERIORITY|||||||0.0569|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.0569
91584831|NCT02318797|183059992|SUPERIORITY|||||||0.0745|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0745
91584832|NCT02318797|183059992|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
91584833|NCT02318797|183059993|SUPERIORITY|||||||0.1653|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1653
91584834|NCT02318797|183059993|SUPERIORITY|||||||0.1772|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.1772
91584835|NCT02318797|183059994|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||<0.0001
91584836|NCT02318797|183059995|SUPERIORITY|||||||0.0202|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0202
91584837|NCT02318797|183059996|SUPERIORITY|||||||0.4715|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.4715
91584838|NCT02318797|183059996|SUPERIORITY|||||||0.9209|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.9209
91584839|NCT01315353|183060064|SUPERIORITY|Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Cumulative rate difference|1.7|||||ONE_SIDED|95.0|-7.9||||||The lower bound of the (lower) one-sided 95% confidence interval was provided.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN2+ with 95% one-sided confidence interval.|||-7.9|
91584840|NCT01315353|183060065|OTHER|||||||0.94||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Log Rank|Log-rank test was stratified by ART use at screening.||Null Hypothesis: There is no difference between Arm A and Arm B with respect to time to CIN2+.||||0.94
91584841|NCT01315353|183060066|OTHER||Cumulative rate difference|4.4|||||TWO_SIDED|95.0|-4.8|13.6|||||Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN3+ with 95% two-sided confidence interval.||13.6|-4.8|
91584842|NCT01315353|183060067|OTHER|||||||0.445||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null hypothesis: There is no difference between Arm A and Arm B with respect to rate of premature study discontinuation.||||0.445
91584843|NCT01315353|183060068|OTHER|||||||1||||||P-value for the week 26 comparison. The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 26.||||1.000
91584844|NCT01315353|183060068|OTHER|||||||0.279||||||"P-value for the week 52 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between the Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 52.||||0.279
91647090|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0236|TWO_SIDED|95.0|-3.1|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-3.1|0.0236
91647091|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2523|TWO_SIDED|95.0|-2.0|0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.5|-2.0|0.2523
91647092|NCT01289990|183185760|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3494|TWO_SIDED|95.0|-1.9|0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.7|-1.9|0.3494
91647093|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1568|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1568
91647094|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1323|TWO_SIDED|95.0|-2.4|0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.3|-2.4|0.1323
91647095|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4327|TWO_SIDED|95.0|-0.8|1.9||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.9|-0.8|0.4327
91584845|NCT01315353|183060068|OTHER|||||||0.781||||||"P-value for the week 78 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 78.||||0.781
91647096|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0289|TWO_SIDED|95.0|-2.8|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.8|0.0289
91584846|NCT01315353|183060068|OTHER|||||||0.375||||||"P-value for the week 104 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 104.||||0.375
91584847|NCT01315353|183060068|OTHER|||||||0.444||||||"P-value for the week 130 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 130.||||0.444
91584848|NCT01315353|183060069|OTHER|||||||0.132||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.132
91778378|NCT01774721|183438039|SUPERIORITY||Hazard Ratio (HR)|0.545|||<|0.0001|TWO_SIDED|95.0|0.418|0.711|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on Investigator assessment||0.711|0.418|<0.0001
91647097|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0231|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0231
91778379|NCT01774721|183438040|SUPERIORITY|||||||0.1942|||||||Cochran-Mantel-Haenszel|||||||0.1942
91778380|NCT01774721|183438041|SUPERIORITY|||||||0.0924|||||||Cochran-Mantel-Haenszel|||||||0.0924
91778381|NCT01774721|183438048|SUPERIORITY||Cox Proportional Hazard|1.173||||0.1641|TWO_SIDED|95.0|0.928|1.483|||Unstratified Log-rank Test|||||1.483|0.928|0.1641
91584849|NCT01315353|183060070|OTHER|||||||0.227||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.227
91584850|NCT01315353|183060071|OTHER|||||||1||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||1.000
91584851|NCT00112047|183060099|NON_INFERIORITY_OR_EQUIVALENCE|Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.4||||0.002|TWO_SIDED|95.0|4.3|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||18.6|4.3|0.002
91584852|NCT00112047|183060100|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|9.1||||0.021|TWO_SIDED|95.0|1.6|16.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||16.6|1.6|0.021
91584853|NCT00112047|183060101|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.2||||0.004|TWO_SIDED|95.0|3.7|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made||Null hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||18.6|3.7|0.004
91584854|NCT00112047|183060102|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|7.9||||0.058|TWO_SIDED|95.0|0.1|15.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||15.6|0.1|0.058
91584855|NCT00112047|183060103|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.003
91584856|NCT00112047|183060104|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.046
91647098|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0513|TWO_SIDED|95.0|-3.0|0.0||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-3.0|0.0513
91647099|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0038|TWO_SIDED|95.0|-3.7|-0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-3.7|0.0038
91647100|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0084|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0084
91647101|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.7||0.0677|TWO_SIDED|95.0|-2.8|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.8|0.0677
91647102|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.0814|TWO_SIDED|95.0|-2.4|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.4|0.0814
91647103|NCT01289990|183185761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.1785|TWO_SIDED|95.0|-2.2|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.2|0.1785
91647104|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.75|-1.69||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.69|-2.75|<0.0001
91647105|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.14|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.66|-1.61||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.61|-2.66|<0.0001
91647106|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.27||0.0223|TWO_SIDED|95.0|0.09|1.14||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.14|0.09|0.0223
91647107|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.84|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.37|-2.31||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.31|-3.37|<0.0001
91647108|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.75|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.28|-2.22|||ANCOVA|||||-2.22|-3.28|<0.0001
91647109|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.09|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.76|-1.41||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.41|-2.76|<0.0001
91647110|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.66|-1.32||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.32|-2.66|<0.0001
91647111|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.27|-1.19||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.19|-2.27|<0.0001
91647112|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.85|-1.76||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.76|-2.85|<0.0001
91647113|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.48|-1.47||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.47|-2.48|<0.0001
91647114|NCT01289990|183185762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.52|-1.5||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.50|-2.52|<0.0001
91647115|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.35|-1.26||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.26|-2.35|<0.0001
91647116|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.56|-1.48||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.48|-2.56|<0.0001
91647117|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0546|TWO_SIDED|95.0|-0.01|1.08||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.08|-0.01|0.0546
91647118|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.89|-1.8||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.80|-2.89|<0.0001
91647119|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-3.1|-2.01||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.01|-3.10|<0.0001
91647120|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.69|-1.24||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.24|-2.69|<0.0001
91647121|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.43|-0.99||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.99|-2.43|<0.0001
91584857|NCT00112047|183060105|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is different between the 2 treatment groups.||||0.026
91584858|NCT00112047|183060106|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.||||0.063
91584859|NCT00112047|183060107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.31|TWO_SIDED|95.0|-0.16|0.06||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.06|-0.16|0.31
91584860|NCT00112047|183060108|SUPERIORITY_OR_OTHER||stratum-weighted difference|31.74||||0.002||95.0|8.96|54.52||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||54.52|8.96|0.002
91584861|NCT00112047|183060109|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|12.7||||0.004|TWO_SIDED|95.0|4.3|21.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.1|4.3|0.004
91584862|NCT00112047|183060110|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|6.4||||0.158|TWO_SIDED|95.0|-2.3|15.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||15.0|-2.3|0.158
91584863|NCT00112047|183060111|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
91647122|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.52|-1.34||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.34|-2.52|<0.0001
91647123|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.79|-1.6||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.60|-2.79|<0.0001
91647124|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.34|-1.27||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.27|-2.34|<0.0001
91584864|NCT00112047|183060112|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.124
91584865|NCT00112047|183060113|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is different between the 2 treatment groups.||||0.025
91584866|NCT00112047|183060114|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.41
91584867|NCT00112047|183060115|SUPERIORITY_OR_OTHER||stratum-weighted difference|-0.05||||0.45||95.0|-0.17|0.08||The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.17|0.45
91584868|NCT00112047|183060116|SUPERIORITY_OR_OTHER||stratum-weighted difference|32.93||||0.036||95.0|0.87|64.99||The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||64.99|0.87|0.036
91584869|NCT00112047|183060117|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum Test|No other adjustments were made.||Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal||||<0.001
91584870|NCT00112047|183060118|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.025
91584871|NCT00112047|183060119|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
91584872|NCT00112047|183060120|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|12.9||||0.004|TWO_SIDED|95.0|4.2|21.6||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.6|4.2|0.004
91584873|NCT00112047|183060121|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|8.1||||0.082|TWO_SIDED|95.0|-0.8|17.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||17.0|-0.8|0.082
91647125|NCT01289990|183185763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.18|-1.11||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.11|-2.18|<0.0001
91647126|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
91584874|NCT00112047|183060122|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|11.6||||0.009||95.0|3.1|20.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null Hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||20.1|3.1|0.009
91584875|NCT00112047|183060123|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|10.4||||0.019|TWO_SIDED|95.0|1.8|19.0||The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||19.0|1.8|0.019
91584876|NCT00112047|183060124|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
91584877|NCT00112047|183060125|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.056
91584878|NCT00112047|183060126|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is different between the 2 treatment groups||||0.066
91647127|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0015|TWO_SIDED|95.0|-2.8|-0.7||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-2.8|0.0015
91647128|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.5052|TWO_SIDED|95.0|-0.7|1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.4|-0.7|0.5052
91647129|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.5|-1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.4|-3.5|<0.0001
91647130|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
91778382|NCT00248040|183438069|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.275||||0.9076|TWO_SIDED|95.0|-5.0|4.45|||Other|||This analysis refers to the 1-3 hours time point||4.45|-5.00|0.9076
91778383|NCT00248040|183438069|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|2.444||||0.3084|TWO_SIDED|95.0|-2.32|7.21|||Other|||This analysis refers to the 1-3 hours timepoint.||7.21|-2.32|0.3084
91778384|NCT00248040|183438069|OTHER||Difference between means|-2.719||||0.2565|TWO_SIDED|95.0|-7.47|2.03|||Other|||||2.03|-7.47|0.2565
91778385|NCT00248040|183438069|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.063||||0.9855|TWO_SIDED|95.0|-6.91|6.79|||Other|||This analysis refers to the 10-12 hours time point.||6.79|-6.91|0.9855
91778386|NCT00248040|183438069|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|4.519||||0.1934|TWO_SIDED|95.0|-2.36|11.39|||Other|||This analysis refers to the 10-12 hours timepoint.||11.39|-2.36|0.1934
91778387|NCT00248040|183438069|OTHER|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-4.582||||0.1797|TWO_SIDED|95.0|-11.3|2.17|||Other|||This analysis refers to the 10-12 hours time point.||2.17|-11.3|0.1797
91778388|NCT00118417|183438084|SUPERIORITY_OR_OTHER|||||||0||95.0||||Paired t-test between endpoint and baseline PDSS|t-test, 2 sided|Degrees of Freedom = 38||||||0.0000
91778389|NCT00118417|183438085|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||T-test of PDSS change score|t-test, 2 sided|Degrees of Freedom = 22||||||0.97
91778390|NCT00118417|183438086|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||T-test of PDSS change between baseline and endpoint of Phase 3|t-test, 2 sided|Degrees of Freedom = 17||||||0.061
91647131|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.0064|TWO_SIDED|95.0|-2.6|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.6|0.0064
91647132|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0642|TWO_SIDED|95.0|-2.1|0.1||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.1|0.0642
91647133|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0053|TWO_SIDED|95.0|-1.8|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.8|0.0053
91647134|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||ANCOVA|||||-0.9|-2.3|<0.0001
91647135|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.1|0.0010
91647136|NCT01289990|183185764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0015|TWO_SIDED|95.0|-2.1|-0.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-2.1|0.0015
91647137|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.0028|TWO_SIDED|95.0|-2.7|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.7|0.0028
91647138|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0019|TWO_SIDED|95.0|-2.8|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.8|0.0019
91647139|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.6||0.5044|TWO_SIDED|95.0|-0.7|1.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.5|-0.7|0.5044
91647140|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0003|TWO_SIDED|95.0|-3.1|-0.9||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-3.1|0.0003
91647141|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6||0.0002|TWO_SIDED|95.0|-3.2|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.2|0.0002
91778391|NCT02978781|183438088|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9143|TWO_SIDED|95.0|-0.44|0.49|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14 (predose)|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.49|-0.44|0.9143
91778392|NCT02978781|183438089|OTHER||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.815||0.0529|TWO_SIDED|95.0|-3.5|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-3.50|0.0529
91778393|NCT02978781|183438095|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|1.326||0.7795|TWO_SIDED|95.0|-3.47|2.7|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.70|-3.47|0.7795
91647142|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0109|TWO_SIDED|95.0|-2.5|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-2.5|0.0109
91521167|NCT02954354|182917030|SUPERIORITY||Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-24.0|-72.0|<0.0001
91647143|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1238|TWO_SIDED|95.0|-1.9|0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-1.9|0.1238
91647144|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.8||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.8|-2.4|<0.0001
91647145|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.0076|TWO_SIDED|95.0|-1.9|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.9|0.0076
91647146|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0049|TWO_SIDED|95.0|-2.1|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.1|0.0049
91647147|NCT01289990|183185765|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0178|TWO_SIDED|95.0|-1.9|-0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-1.9|0.0178
91647148|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-37.8|-26.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-26.7|-37.8|<0.0001
91647149|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-37.2|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-42.8|-31.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-31.7|-42.8|<0.0001
91647150|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-22.9|-11.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-11.7|-22.9|<0.0001
91647151|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-20.6|-9.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.4|-20.6|<0.0001
91521168|NCT02954354|182917031|SUPERIORITY||Difference|-24.0||||0.002|TWO_SIDED|95.0|-120.0|0.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||0.0|-120.0|0.0020
91647152|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-25.5|-14.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-14.4|-25.5|<0.0001
91647153|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.1|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-35.0|-19.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.2|-35.0|<0.0001
91708598|NCT02207400|183310065|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.652|||<|0.0001|TWO_SIDED|95.0|-0.738|-0.566|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-0.566|-0.738|<0.0001
91647154|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-38.9|-23.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-23.2|-38.9|<0.0001
91708599|NCT02849704|183310071|SUPERIORITY||||||<|0.001||||||a priori threshold for significance: \<0.05|t-test, 2 sided|||||||<0.001
91708600|NCT02849704|183310072|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
91708601|NCT02849704|183310073|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.01
91647155|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-24.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-29.7|-18.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-18.9|-29.7|<0.0001
91647156|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-32.7|-21.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-21.9|-32.7|<0.0001
91647157|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.8|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-33.6|-22.0||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.0|-33.6|<0.0001
91708602|NCT02849704|183310074|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
91647158|NCT01289990|183185766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-34.5|-22.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.8|-34.5|<0.0001
91708603|NCT02849704|183310075|SUPERIORITY||||||<|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.05
91521169|NCT02954354|182917032|SUPERIORITY||Difference|-24.0||||0.0102|TWO_SIDED|95.0|-48.0|24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||24.0|-48.0|0.0102
91521170|NCT02954354|182917033|SUPERIORITY|||||||0.5973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.5973
91521171|NCT02954354|182917033|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.0010
91521172|NCT02954354|182917033|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
91521173|NCT02954354|182917033|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
91521174|NCT02954354|182917033|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
91521175|NCT02954354|182917033|SUPERIORITY|||||||0.0115||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.0115
91708604|NCT02849704|183310076|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
91584879|NCT00112047|183060127|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is different between the 2 treatment groups||||0.30
91584880|NCT00112047|183060128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.16|0.08||The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.16|0.39
91584881|NCT00112047|183060129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|41.3||||0.089|TWO_SIDED|95.0|4.05|78.55||The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||78.55|4.05|0.089
91584882|NCT00112047|183060130|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.001
91584883|NCT00112047|183060131|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.011
91584884|NCT00112047|183060132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
91584885|NCT00112047|183060142|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.||||0.16
91584886|NCT00112047|183060143|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.||||0.049
91584887|NCT00112047|183060144|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.||||0.055
91584888|NCT00112047|183060145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||<0.001
91584889|NCT00112047|183060146|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.12
91647159|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-37.4|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-37.4|<0.0001
91584890|NCT00112047|183060147|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.037
91584891|NCT00112047|183060148|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.013
91584892|NCT00112047|183060149|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||"The number and proportion of participants in each category (bothers, does not bother) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.70
91584893|NCT00112047|183060150|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value is from the Wilcoxon Signed Rank Test.|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.95
91584894|NCT00112047|183060151|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value is from the Wilcoxon Signed Rank Test|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.23
91584895|NCT01101477|183060193|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The patients with at lease one episode of hypoxemia (SPaO2\<90%) during FB were analyzed by Chi-square test. P value less 0.05 means significance, 2-sided.||||0.05
91584896|NCT01605292|183060200|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91647160|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-40.7|-29.1||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-29.1|-40.7|<0.0001
91647161|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-22.1|-10.5||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-10.5|-22.1|<0.0001
91584897|NCT01605292|183060201|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
91584898|NCT01605292|183060202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91584899|NCT01605292|183060203|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Fisher Exact|||||||0.56
91584900|NCT01605292|183060204|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91584901|NCT01605292|183060205|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared|||||||0.07
91584902|NCT01605292|183060206|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.75
91584903|NCT01605292|183060208|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||||||0.007
91647162|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-21.2|-9.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.6|-21.2|<0.0001
91584904|NCT01786174|183060221|SUPERIORITY_OR_OTHER||Slope|1.4|STANDARD_ERROR_OF_MEAN|4.3||0.746|TWO_SIDED|95.0|-7.17|9.96|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||9.96|-7.17|0.746
91584905|NCT01786174|183060222|SUPERIORITY_OR_OTHER||Slope|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.53|2.03|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||2.03|-1.53|0.780
91584906|NCT01786174|183060223|SUPERIORITY_OR_OTHER||Slope|-0.51|STANDARD_ERROR_OF_MEAN|2.26||0.823|TWO_SIDED|95.0|-5.0|3.99|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||3.99|-5.00|0.823
91584907|NCT01786174|183060225|SUPERIORITY_OR_OTHER||Slope|4.27|STANDARD_ERROR_OF_MEAN|4.04||0.294|TWO_SIDED|95.0|-3.78|12.33|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||12.33|-3.78|0.294
91584908|NCT03442985|183060231|OTHER||Risk Ratio (RR)|2.109||||0.2556|TWO_SIDED|95.0|0.583|7.638||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg versus (vs) Palovarotene 5.0 mg: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.638|0.583|0.2556
91584909|NCT03442985|183060231|OTHER||Risk Ratio (RR)|3.04||||0.1788|TWO_SIDED|95.0|0.601|15.373||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||15.373|0.601|0.1788
91584910|NCT03442985|183060231|OTHER||Risk Ratio (RR)|1.441||||0.657|TWO_SIDED|95.0|0.287|7.234||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.234|0.287|0.6570
91584911|NCT03442985|183060232|OTHER||Risk Ratio (RR)|-4412.6||||0.4252|TWO_SIDED|95.0|-15257.3|6432.1||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6432.1|-15257.3|0.4252
91584912|NCT03442985|183060232|OTHER||Risk Ratio (RR)|-4640.9||||0.4053|TWO_SIDED|95.0|-15570.8|6289.0||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6289.0|-15570.8|0.4053
91584913|NCT03442985|183060232|OTHER||Risk Ratio (RR)|-228.3||||0.9677|TWO_SIDED|95.0|-11265.0|10808.4||The p-values were not adjusted for multiple testings due to small sample size.|Unadjusted estimation equation model|||Palovarotene 5.0 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||10808.4|-11265.0|0.9677
91584914|NCT03442985|183060233|OTHER||Odds Ratio (OR)|0.643||||0.5025|TWO_SIDED|95.0|0.177|2.335|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.335|0.177|0.5025
91647163|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-18.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-24.5|-12.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-12.8|-24.5|<0.0001
91584915|NCT03442985|183060233|OTHER||Odds Ratio (OR)|0.528||||0.3763|TWO_SIDED|95.0|0.128|2.175|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.175|0.128|0.3763
91584916|NCT03442985|183060233|OTHER||Odds Ratio (OR)|0.82||||0.7714|TWO_SIDED|95.0|0.215|3.123|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||3.123|0.215|0.7714
91584917|NCT03442985|183060234|OTHER||Risk Ratio (RR)|0.951||||0.8155|TWO_SIDED|95.0|0.623|1.451||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.451|0.623|0.8155
91584918|NCT03442985|183060234|OTHER||Risk Ratio (RR)|1.003||||0.9918|TWO_SIDED|95.0|0.592|1.699||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.699|0.592|0.9918
91584919|NCT03442985|183060234|OTHER||Risk Ratio (RR)|1.055||||0.7997|TWO_SIDED|95.0|0.7|1.589||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.589|0.700|0.7997
91647164|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-31.4|-15.3||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-15.3|-31.4|<0.0001
91584920|NCT03442985|183060235|OTHER||Risk Ratio (RR)|1.548||||0.2186|TWO_SIDED|95.0|0.772|3.108||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||3.108|0.772|0.2186
91584921|NCT03442985|183060235|OTHER||Risk Ratio (RR)|1.655||||0.27|TWO_SIDED|95.0|0.676|4.052||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||4.052|0.676|0.2700
91584922|NCT03442985|183060235|OTHER||Risk Ratio (RR)|1.069||||0.8546|TWO_SIDED|95.0|0.524|2.178||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||2.178|0.524|0.8546
91584923|NCT00084266|183060253|NON_INFERIORITY_OR_EQUIVALENCE|The final p-value was compared against an O'Brien-Fleming boundary of 0.048.||||||0.042|TWO_SIDED||||||Chi-squared|||"Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as cure."||||0.042
91584924|NCT00084266|183060265|SUPERIORITY_OR_OTHER|||||||0.9344|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.9344
91584925|NCT00084266|183060266|SUPERIORITY_OR_OTHER|||||||0.5985|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.5985
91584926|NCT00084266|183060267|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.8590
91584927|NCT01215422|183060268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||>|0.05|ONE_SIDED|95.0|0.15||||Regression, Logistic||||||0.15|>0.05
91584928|NCT01215422|183060269|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The p-value represents the comparison of the two interventions combined and compared against baseline for Grades III and IV summed together.|Fisher Exact|||||||0.03
91584929|NCT01215422|183060272|SUPERIORITY_OR_OTHER||R-squared|0.16|||>|0.05||95.0||||Correlation between years of experience (all anesthesiologists, pooled) and time to intubation (both GS and KS VLSs, pooled)|Correlation|||||||>0.05
91647165|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.4|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-35.4|-19.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.4|-35.4|<0.0001
91708605|NCT02771860|183310096|SUPERIORITY||Mean Difference (Final Values)|8.9||||0.024|TWO_SIDED|95.0|1.0|16.9|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||16.9|1.0|0.024
91584930|NCT00420017|183060276|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.02|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||||0.86|0.16|0.02
91584931|NCT00420017|183060277|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
91647166|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.1|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-30.5|-19.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.6|-30.5|<0.0001
91647167|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-36.9|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-36.9|<0.0001
91584932|NCT00420017|183060278|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.097
91584933|NCT00420017|183060279|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
91584934|NCT02864381|183060284|SUPERIORITY||Odds Ratio (OR)|1.5||||0.8|TWO_SIDED|95.0|0.4|6.1||P-value is derived from Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status.|Cochran-Mantel-Haenszel||Odds Ratio is derived from CMH test stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||6.1|0.4|0.8
91584935|NCT02864381|183060285|SUPERIORITY||Hazard Ratio (HR)|0.836||||0.306|TWO_SIDED|95.0|0.589|1.189||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.189|0.589|0.306
91584936|NCT02864381|183060286|SUPERIORITY||Hazard Ratio (HR)|0.786||||0.312|TWO_SIDED|95.0|0.491|1.257||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.257|0.491|0.312
91584937|NCT00120406|183060301|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 10%.|||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|z-test, one-sided|||||||<0.01
91584938|NCT00120406|183060302|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|Generalized estimating equation (GEE)|||||||<0.01
91584939|NCT06336603|183060304|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< .001
91584940|NCT06336603|183060305|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< .001
91584941|NCT06336603|183060306|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< .001
91584942|NCT00388453|183060322|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
91584943|NCT01259726|183060414|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<=0.0001
91584944|NCT01259726|183060414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
91584945|NCT01259726|183060414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
91584946|NCT01259726|183060415|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
91584947|NCT01259726|183060415|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.002
91584948|NCT01259726|183060415|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
91584949|NCT01259726|183060416|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.054|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.054
91584950|NCT01259726|183060416|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.008
91647168|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.0|-24.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-24.9|-37.0|<0.0001
91647169|NCT01289990|183185767|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.9|-25.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.7|-37.9|<0.0001
91708606|NCT02771860|183310097|SUPERIORITY||Odds Ratio (OR)|0.23|||<|0.001|TWO_SIDED|95.0|0.11|0.5|||Regression, Logistic|||||0.50|0.11|<0.001
91708607|NCT02771860|183310098|SUPERIORITY||Mean Difference (Final Values)|14.3||||0.003|TWO_SIDED|95.0|4.6|24.0|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||24.0|4.6|0.003
91584951|NCT01259726|183060416|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.101
91584952|NCT01259726|183060417|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
91584953|NCT01259726|183060417|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.066|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.066
91584954|NCT01259726|183060417|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
91584955|NCT02656160|183060464|OTHER|||||||0.85||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||tonic||||0.85
91584956|NCT02656160|183060464|OTHER|||||||0.322||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||Phasic activity||||0.322
91584957|NCT02656160|183060465|OTHER|||||||0.42||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.42
91584958|NCT00926211|183060471|NON_INFERIORITY_OR_EQUIVALENCE|Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.|Mean Difference (Net)|-1.4|STANDARD_DEVIATION|15.5||0.023|ONE_SIDED|97.5||3.9||t-test comparison to the upper limit of the non-inferiority margin|t-test, 1 sided|Paired t-test compared to the non-inferiority margin of 4 follicles.|The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.|The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.||3.9||0.023
91584959|NCT00926211|183060472|NON_INFERIORITY_OR_EQUIVALENCE|Study was powered for the primary efficacy outcome.|Mean Difference (Final Values)|0.045|STANDARD_DEVIATION|0.146|<|0.001|ONE_SIDED|97.5|-0.004||||t-test, 1 sided|Paired t-test.||Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.|||-.004|<0.001
91584960|NCT03581825|183060473|SUPERIORITY|Statistically superiority was concluded if the lower limit of the confidence intervals of the Test lens are greater than 40 points.|Least-Square Mean|56.3|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|95.0|51.2|61.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||61.4|51.2|
91647170|NCT00363129|183185771|SUPERIORITY_OR_OTHER|||||||0.43|||||||Chi-squared|||||||0.43
91647171|NCT00363129|183185772|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
91647172|NCT00363129|183185773|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91647173|NCT01345058|183185842|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.49|TWO_SIDED|95.0|0.35|1.65|||Chi-squared||Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.|||1.65|0.35|0.49
91647174|NCT01892020|183185853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.27|<|0.001||95.0|-1.66|-0.58||The 2-h PPG increment was analyzed using a normal linear mixed model with period and treatment as fixed effects and subject as a random effect.|Mixed Models Analysis|||Let D be the treatment difference (BIAsp 50 BID + metformin minus BHI 50 BID + metformin) of 2-h PPG increment after a 4-week treatment. The null hypothesis was D = 0 mmol/L. The alternative hypothesis was D ≠ 0 mmol/L. Sample size was determined using a two-sided one sample t-test at a = 0.05 under the assumption of 0.8 mmol/L mean treatment different and 80% power.||-0.58|-1.66|< 0.001
91647175|NCT03162354|183185865|OTHER||Odds Ratio (OR)|0.64||||0.11|TWO_SIDED|95.0|0.37|1.11||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|We powered this hypothesis to detect a 17% increase (from 73% to 90%) in higher risk patients evaluated thoroughly for abuse at intervention sites, compared to baseline in prior PediBIRN studies. Generalized linear mixed-effects models were adopted to analyze 1,000 Monte Carlo datasets from simulation. For the target sample size of 304 higher risk patients (152 in each arm), the proportion of simulated datasets that yielded a statistically significant result for the primary hypothesis was 95.7%.||1.11|0.37|0.11
91647176|NCT03162354|183185866|OTHER||Odds Ratio (OR)|0.69||||0.49|TWO_SIDED|95.0|0.24|1.98||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.98|0.24|0.49
91647177|NCT03162354|183185867|OTHER||Odds Ratio (OR)|1.88||||0.22|TWO_SIDED|95.0|0.69|5.13||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||5.13|0.69|0.22
91647178|NCT03162354|183185868|OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.85|0.27|0.01
91647179|NCT03162354|183185869|OTHER||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.46|2.6||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.60|0.46|0.84
91647180|NCT03162354|183185870|OTHER||Odds Ratio (OR)|1.84||||0.05|TWO_SIDED|95.0|1.0|3.38||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.38|1.00|0.05
91647181|NCT03162354|183185871|OTHER||Odds Ratio (OR)|1.22||||0.71|TWO_SIDED|95.0|0.43|3.49||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.49|0.43|0.71
91647182|NCT03162354|183185872|OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.7|1.53||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.53|0.70|0.86
91647183|NCT03162354|183185873|OTHER||Odds Ratio (OR)|2.02||||0.01|TWO_SIDED|95.0|1.16|3.52||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline prior studies to the cluster randomized trial|||3.52|1.16|0.01
91647184|NCT03162354|183185874|OTHER||Odds Ratio (OR)|0.42|||<|0.001|TWO_SIDED|95.0|0.26|0.67||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior studies to the cluster randomized trial.|||0.67|0.26|<.001
91521176|NCT02954354|182917033|SUPERIORITY|||||||0.1298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.1298
91647185|NCT03162354|183185875|OTHER||Odds Ratio (OR)|0.46||||0.14|TWO_SIDED|95.0|0.16|1.31||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior PediBIRN studies to the clinical trial.|||1.31|0.16|0.14
91647186|NCT03162354|183185877|OTHER||Odds Ratio (OR)|0.74||||0.57|TWO_SIDED|95.0|0.27|2.05||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.05|0.27|0.57
91647187|NCT03162354|183185878|OTHER||Odds Ratio (OR)|0.63||||0.04|TWO_SIDED|95.0|0.4|0.99||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.99|0.40|0.04
91647188|NCT02149199|183185885|SUPERIORITY||Odds Ratio (OR)|1.14||||0.046|TWO_SIDED|95.0|1.0|1.3|||Regression, Logistic|Repeated measures logistic regression, with treatment, pre-study treatment, region and study week as fixed effects.|An odds ratio greater than 1 favours Symbicort 'as needed'|||1.30|1.00|0.046
91647189|NCT02149199|183185885|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI \>=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid.|Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.57|0.73|||Regression, Logistic|Repeated measures logistic regression with treatment, pre-study treatment, region and study week as fixed effects.||||0.73|0.57|
91708608|NCT04304508|183310105|OTHER|Dose-response test by using multiple comparison procedures (MCP) Mod.||||||0.7976|||||||MCP Mod|||Dose-response test||||0.7976
91708609|NCT04304508|183310105|OTHER||Crude incidence ratio|1.044|||||TWO_SIDED|90.0|0.8105|1.3478||||||Comparison of the Asundexian 10 mg group versus Placebo group.||1.3478|0.8105|
91584961|NCT03581825|183060474|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control was concluded if the lower confidence limit of LSM difference was above the non-inferiority margin -5.|Least-Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-0.5|7.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||7.4|-0.5|
91584962|NCT00585195|183060498|SUPERIORITY||Ratio of adjusted geometric means|131.72|||||TWO_SIDED|90.0|96.59|179.63||||||||179.63|96.59|
91584963|NCT00585195|183060498|SUPERIORITY||Ratio of adjusted geometric means|239.03|||||TWO_SIDED|90.0|172.14|331.93||||||||331.93|172.14|
91584964|NCT00585195|183060498|SUPERIORITY||Ratio of adjusted geometric means|201.56|||||TWO_SIDED|90.0|139.33|291.58||||||||291.58|139.33|
91584965|NCT00585195|183060499|SUPERIORITY||Ratio of adjusted geometric means|216.19|||||TWO_SIDED|90.0|161.41|289.56||||||||289.56|161.41|
91584966|NCT00585195|183060499|SUPERIORITY||Ratio of adjusted geometric means|350.0|||||TWO_SIDED|90.0|141.09|868.23||||||||868.23|141.09|
91584967|NCT00585195|183060499|SUPERIORITY||Ratio of adjusted geometric means|365.43|||||TWO_SIDED|90.0|263.22|507.31||||||||507.31|263.22|
91584968|NCT00585195|183060502|SUPERIORITY||Ratio of adjusted geometric mean|15.57|||||TWO_SIDED|90.0|10.89|22.26||||||||22.26|10.89|
91584969|NCT00585195|183060503|SUPERIORITY||Ratio of adjusted geometric mean|20.64|||||TWO_SIDED|90.0|14.59|29.18||||||||29.18|14.59|
91584970|NCT00585195|183060505|SUPERIORITY||Ratio of adjusted geometric means|157.4|||||TWO_SIDED|90.0|136.89|180.97||||||||180.97|136.89|
91584971|NCT00585195|183060506|SUPERIORITY||Ratio of adjusted geometric means|132.81|||||TWO_SIDED|90.0|119.1|148.1||||||||148.10|119.10|
91584972|NCT00529958|183060545|EQUIVALENCE|The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.|||||<|0.05||||||A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.|Mixed Models Analysis|||"All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment."||||<0.05
91584973|NCT03319849|183060578|SUPERIORITY||Median Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.0206||0.0186|TWO_SIDED|95.0|-0.089|-0.0082|||Mixed Models Analysis|||||-0.0082|-0.0890|0.0186
91584974|NCT00720941|183060609|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.|Hazard Ratio (HR)|1.0466|||||TWO_SIDED|95.0|0.8982|1.2195|||||The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).|||1.2195|0.8982|
91584975|NCT01313637|183060672|SUPERIORITY_OR_OTHER||Least squares mean difference|0.16|||<|0.001|TWO_SIDED|95.0|0.122|0.198|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.198|0.122|<0.001
91584976|NCT01313637|183060672|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.086|0.162|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.162|0.086|<0.001
91584977|NCT01313637|183060672|SUPERIORITY_OR_OTHER||Least squares mean difference|0.238|||<|0.001|TWO_SIDED|95.0|0.2|0.276|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus Placebo.|||0.276|0.200|<0.001
91584978|NCT01313637|183060672|SUPERIORITY_OR_OTHER||Least squares mean difference|0.079|||<|0.001|TWO_SIDED|95.0|0.046|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus UMEC 125 µg.|||0.112|0.046|<0.001
91708610|NCT04304508|183310105|OTHER||Crude incidence ratio|1.1963|||||TWO_SIDED|90.0|0.9281|1.5428||||||Comparison of the Asundexian 20 mg group versus Placebo group.||1.5428|0.9281|
91584979|NCT01313637|183060672|SUPERIORITY_OR_OTHER||Least squares mean difference|0.114|||<|0.001|TWO_SIDED|95.0|0.081|0.148|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus VI 25 µg.|||0.148|0.081|<0.001
91584980|NCT00655863|183060770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-307.229|||<|0.001|TWO_SIDED|95.0|-443.168|-171.29||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-171.290|-443.168|<0.001
91584981|NCT00655863|183060770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-253.711|||<|0.001||95.0|-394.161|-113.262||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-113.262|-394.161|<0.001
91584982|NCT01138007|183060788|SUPERIORITY_OR_OTHER||Least Squared Mean Difference|-0.5||||0.853|TWO_SIDED|95.0|-2.7|1.7||The p-value was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates. The multiplicity was adjusted by Dunnett's step-down procedure.|ANCOVA||The confidence interval was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|||1.7|-2.7|0.853
91584983|NCT01138007|183060788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||||95.0|||||||In the analysis plan, the second comparison of interest was not to be performed if the first comparison failed to show statistical significance.|||||
91584984|NCT03548987|183060797|SUPERIORITY||Treatment difference|-14.75|||<|0.0001|TWO_SIDED|95.0|-16.0|-13.5|||ANCOVA|||Treatment policy estimand||-13.50|-16.00|<0.0001
91584985|NCT03548987|183060797|OTHER||Treatment difference|-15.33|||<|0.0001|TWO_SIDED|95.0|-16.52|-14.13|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-14.13|-16.52|<0.0001
91584986|NCT04572841|183060834|SUPERIORITY||Least Square Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.39|2.02||||||Analysis was performed for change from baseline using a mixed model for repeated measures with visit, intervention group (SAR441344 and Placebo), and visit by intervention group interaction as fixed categorical effects, and participant specific baseline ESSDAI as continuous covariate.||2.02|-1.39|
91584987|NCT00712673|183060868|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.657|-0.312||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.312|-0.657|<0.0001
91584988|NCT00712673|183060868|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.54|-0.193||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.193|-0.540|<0.0001
91584989|NCT01468831|183060890|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|7.4|||TWO_SIDED|95.0|-10.6|26.1|||||Difference = Minocycline - Placebo|||26.1|-10.6|
91584990|NCT01468831|183060891|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|1.1|STANDARD_DEVIATION|1.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91584991|NCT01468831|183060892|OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.||||
91584992|NCT01468831|183060893|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.3|||TWO_SIDED|95.0|-3.9|2.3|||||Difference = Minocycline - Placebo|||2.3|-3.9|
91584993|NCT01468831|183060894|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-2.1|STANDARD_DEVIATION|1.0|||TWO_SIDED|95.0|-4.5|0.3|||||Difference = Minocycline - Placebo|||0.3|-4.5|
91584994|NCT01468831|183060895|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|-7.5|2.5|||||Difference = Minocycline - Placebo|||2.5|-7.5|
91647190|NCT02149199|183185886|SUPERIORITY||Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.328|0.577|||Regression, Cox|Cox-regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0, \>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||0.577|0.328|<0.001
91708611|NCT04304508|183310105|OTHER||Crude incidence ratio|1.0485|||||TWO_SIDED|90.0|0.8082|1.3619||||||Comparison of the Asundexian 50 mg group versus Placebo group.||1.3619|0.8082|
91708612|NCT04304508|183310113|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.724|||=|0.1507|TWO_SIDED|90.0|0.924|3.215|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||3.215|0.924|= 0.1507
91778394|NCT02978781|183438096|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.473||0.4846|TWO_SIDED|95.0|-0.65|1.33|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.33|-0.65|0.4846
91708613|NCT04304508|183310113|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.285|||=|0.5339|TWO_SIDED|90.0|0.662|2.494|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.494|0.662|= 0.5339
91708614|NCT04304508|183310113|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.749|||=|0.1401|TWO_SIDED|90.0|0.938|3.262|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.262|0.938|= 0.1401
91708615|NCT04304508|183310113|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.585|||=|0.1653|TWO_SIDED|90.0|0.918|2.736|||Log Rank|||Comparison of the Total Asundexian group versus Placebo group||2.736|0.918|= 0.1653
91708616|NCT00885378|183310122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.51|STANDARD_ERROR_OF_MEAN|6.162||0.1248|TWO_SIDED|95.0|-21.68|2.66|||ANCOVA|ANCOVA model: post - pre = pretreatment.|Estimate = adjusted mean change for Saxagliptin - adjusted mean change for Placebo.|||2.66|-21.68|0.1248
91708617|NCT00885378|183310123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||||TWO_SIDED|95.0|1.1|25.4|||||Adjusted for baseline.|||25.4|1.1|
91708618|NCT00885378|183310124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|3.0|24.7|||||Adjusted for baseline.|||24.7|3.0|
91708619|NCT00885378|183310131|SUPERIORITY_OR_OTHER||Standard Error of the Mean|-0.34||||0.0063|TWO_SIDED|95.0|-0.58|-0.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo at Week 12(LOCF) was adjusted for baseline.|difference between week t value - baseline value = baseline value + treatment.|||-0.10|-0.58|0.0063
91708620|NCT01393522|183310137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||ANCOVA|||||||0.1
91708621|NCT01393522|183310137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
91708622|NCT01393522|183310138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
91708623|NCT01393522|183310139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED||||||ANCOVA|||||||0.75
91708624|NCT01393522|183310139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||0.24
91708625|NCT01393522|183310140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
91708626|NCT01393522|183310141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||||||0.41
91708627|NCT01393522|183310142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
91708628|NCT01393522|183310143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
91708629|NCT03746405|183310144|SUPERIORITY||Mean Difference (Final Values)|1.15|||=|0.03|TWO_SIDED|||||Give the limited sample size, this p-value was not adjusted for multiple comparisons. The threshold for statistical significant was p \< 0.05|t-test, 2 sided|||Hypothesis: Active rTMS applied over the node in the medial prefrontal cortex the most strongly negatively connected to the right amygdala will decrease amygdala BOLD activation compared to sham rTMS||||= 0.03
91708630|NCT03479008|183310145|OTHER||||||<|0.0001||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||This presents the p value for the thigh comparison baseline to during stimulation||||<0.0001
91708631|NCT03479008|183310145|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This presents the p value for the calf comparisons between baseline and during stimulation.||||<0.0001
91708632|NCT03479008|183310145|OTHER||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This statistical analysis presents the data for the biceps comparisons between baseline and during stimulation.||||<0.001
91708633|NCT03479008|183310146|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||The P value below applies to the VO2||||<0.0001
91708634|NCT03479008|183310146|SUPERIORITY||||||<|0.001|||||||post-hoc analysis|with Bonferroni correction||This p value applies to the VCO2||||<0.001
91708635|NCT03479008|183310147|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
91708636|NCT03479008|183310148|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
91708637|NCT03479008|183310149|SUPERIORITY|||||||0.094|||||||post-hoc analysis|with Bonferroni correction||||||0.094
91708638|NCT03479008|183310150|SUPERIORITY|||||||0.011||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for Muscle bellies of Soleus (SO)||||0.011
91708639|NCT03479008|183310150|SUPERIORITY|||||||0.012|||||||ANOVA|Statistical significance level was set at p \< 0.05 for all tests.||Comparison of Vibration to Baseline for tibialis anterior (TA)||||0.012
91708640|NCT03479008|183310150|SUPERIORITY|||||||0.003||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for gastrocnemius lateralis (GL)||||0.003
91708641|NCT03479008|183310150|SUPERIORITY||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus medialis (VM)||||<0.001
91584995|NCT01468831|183060896|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-3.5|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-9.4|2.4|||||Difference = Minocycline - Placebo|||2.4|-9.4|
91584996|NCT01468831|183060897|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-3.7|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-9.5|2.0|||||Difference = Minocycline - Placebo|||2|-9.5|
91584997|NCT01468831|183060898|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|5.8|STANDARD_DEVIATION|9.1|||TWO_SIDED|95.0|-17.1|28.6|||||Difference = Minocycline - Placebo|||28.6|-17.1|
91584998|NCT01468831|183060899|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-51.8|STANDARD_DEVIATION|70.8|||TWO_SIDED|95.0|-231.2|127.6|||||Difference = Minocycline - Placebo|||127.6|-231.2|
91584999|NCT01468831|183060900|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-45.5|STANDARD_DEVIATION|153.5|||TWO_SIDED|95.0|-522.6|431.6|||||Difference = Minocycline - Placebo|||431.6|-522.6|
91585000|NCT01468831|183060901|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-12.8|STANDARD_DEVIATION|163.8|||TWO_SIDED|95.0|-513.1|487.6|||||Difference = Minocycline - Placebo|||487.6|-513.1|
91585001|NCT01468831|183060902|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-9.5|STANDARD_DEVIATION|156.8|||TWO_SIDED|95.0|-487.0|468.0|||||Difference = Minocycline - Placebo|||468|-487|
91585002|NCT01468831|183060903|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91585003|NCT01468831|183060904|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91585004|NCT01468831|183060905|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91585005|NCT01468831|183060905|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91585006|NCT01468831|183060905|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91647191|NCT02149199|183185886|SUPERIORITY||Hazard Ratio (HR)|0.901||||0.524|TWO_SIDED|95.0|0.653|1.242|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.242|0.653|0.524
91585007|NCT01468831|183060906|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91585008|NCT01468831|183060906|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91647192|NCT02149199|183185887|SUPERIORITY||Hazard Ratio (HR)|0.429|||<|0.001|TWO_SIDED|95.0|0.348|0.528|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||0.528|0.348|<0.001
91585009|NCT01468831|183060906|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91585010|NCT01287065|183060924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.377|||||TWO_SIDED|90.0|0.293|0.462|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg PM minus Placebo|||0.462|0.293|
91585011|NCT01287065|183060924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.422|||||TWO_SIDED|90.0|0.337|0.507|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minus Placebo|||0.507|0.337|
91585012|NCT01287065|183060924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|||||TWO_SIDED|90.0|-0.125|0.036|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minusFF/VI 100/25 µg PM|||0.036|-0.125|
91708642|NCT03479008|183310150|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus lateralis (VL)||||<0.0001
91708643|NCT03479008|183310150|SUPERIORITY|||||||0.59||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for rectus femoris (RF)||||0.59
91708644|NCT03479008|183310150|SUPERIORITY|||||||0.86||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for semitendinosus (ST)||||0.86
91708645|NCT03479008|183310150|SUPERIORITY|||||||0.006||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for deltoideus medius||||0.006
91708646|NCT00412932|183310151|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
91708647|NCT00412932|183310152|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
91708648|NCT00412932|183310153|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.|one-sample t-test|||||||<0.0001
91708649|NCT00412932|183310154|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. The P-Value of \<0.0001 applies to both daytime and nighttime periods.|one-sample t-test|||||||<0.0001
91708650|NCT00929994|183310164|OTHER||||||=|0.06||||||A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all \>.05).|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.||||=0.06
91708651|NCT00929994|183310164|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91708652|NCT00929994|183310165|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91708653|NCT00929994|183310166|SUPERIORITY|||||||0.04||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts.|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.||||0.04
91708654|NCT00929994|183310167|SUPERIORITY||||||>|0.05||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.||||>0.05
91708655|NCT03258645|183310169|OTHER||||||<|0.001|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.||||< 0.001
91708656|NCT03258645|183310170|OTHER|||||||0.01|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.||||0.01
91708657|NCT03258645|183310171|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.13||||0.016|TWO_SIDED|95.0|1.02|1.25|||Regression, Linear|Relation between age and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.25|1.02|0.016
91708658|NCT03258645|183310172|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.12||||0.002|TWO_SIDED|95.0|1.04|1.21|||Regression, Linear|Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.04|0.002
91708659|NCT03258645|183310173|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.1||||0.04|TWO_SIDED|95.0|1.0|1.21|||Regression, Linear|Relation between CHA2DS2-VASc and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.00|0.04
91708660|NCT03258645|183310174|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.9||||0.051|TWO_SIDED|95.0|0.45|1.0|||Regression, Linear|Relation between HAS-BLED and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.00|0.45|0.051
91710800|NCT02258217|183314012|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|3.03||0.003|TWO_SIDED|95.0|-2.9|-0.66|||Paired t-test, 2 sided|||"We compared the two ADL scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post ADL scores."||-0.66|-2.9|0.003
91585013|NCT02594826|183061026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|35.8|||<|0.001|TWO_SIDED|95.0|11.1|114.9|||Mixed Models Analysis|This is the calculated p-value, which is adjusted for age, marital status, prior screening, health insurance, and having a healthcare provider.||||114.9|11.1|<0.001
91585014|NCT02594826|183061027|SUPERIORITY|||||||0.005|||||||Regression, Linear|Controlling for: marital status, education, language spoken at home, health insurance, regular physician, language of physician, ever had Pap test.||The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.||||0.005
91585015|NCT01242800|183061051|SUPERIORITY|||||||0.32|||||||Log Rank|Stratified log rank test was used for arm comparison||||||0.32
91647193|NCT02149199|183185887|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.436|TWO_SIDED|95.0|0.718|1.153|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||1.153|0.718|0.436
91585016|NCT04508023|183061057|SUPERIORITY||Cox Proportional Hazard|1.16||||0.626|TWO_SIDED|95.0|0.63|2.15|||Log Rank|Log rank test stratified by the time from COVID-19 positive test to randomization.||||2.15|0.63|0.626
91585017|NCT00511901|183061117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
91585018|NCT00511901|183061118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||1||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 3 weeks||||1.00
91585019|NCT00511901|183061118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 8 weeks||||0.17
91585020|NCT00511901|183061118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 12 weeks||||0.59
91647194|NCT02149199|183185888|SUPERIORITY||Mean Difference (Net)|53.8|||<|0.001|TWO_SIDED|95.0|29.1|78.5|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||78.5|29.1|<0.001
91708661|NCT03258645|183310175|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.91||||0.026|TWO_SIDED|95.0|0.9|0.93|||Regression, Linear|Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||0.93|0.9|0.026
91585021|NCT00511901|183061119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
91585022|NCT00511901|183061120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 3 weeks||||0.66
91647195|NCT02149199|183185888|SUPERIORITY||Mean Difference (Net)|-54.3|||<|0.001|TWO_SIDED|95.0|-78.8|-29.8|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||-29.8|-78.8|<0.001
91585023|NCT00511901|183061120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 8 weeks||||1.00
91585024|NCT00511901|183061120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 12 weeks||||0.53
91585025|NCT00511901|183061121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 3 weeks||||0.96
91585026|NCT00511901|183061121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||1||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 8 weeks||||1.00
91585027|NCT00511901|183061121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 12 weeks||||0.66
91585028|NCT00511901|183061122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.64||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 3 weeks||||0.64
91585029|NCT00511901|183061122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 8 weeks||||0.83
91585030|NCT00511901|183061122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 12 weeks||||0.46
91647196|NCT02149199|183185889|SUPERIORITY||Mean Difference (Net)|11.95|||<|0.001|TWO_SIDED|95.0|7.89|16.0|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||16.00|7.89|<0.001
91585031|NCT00511901|183061123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.57||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 3 weeks||||0.37
91585032|NCT00511901|183061123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.39||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 8 weeks||||0.69
91585033|NCT00511901|183061123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.15||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 12 weeks||||0.36
91585034|NCT00511901|183061124|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.97||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 3 weeks||||0.97
91585035|NCT00511901|183061124|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 8 weeks||||0.46
91585036|NCT00511901|183061124|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 12 weeks||||0.68
91585037|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.938|TWO_SIDED|95.0||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.938
91585038|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.451||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.451
91585039|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.819||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.819
91521177|NCT02954354|182917033|SUPERIORITY|||||||0.117||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.1170
91521178|NCT02954354|182917033|SUPERIORITY|||||||0.0757||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.0757
91647197|NCT02149199|183185889|SUPERIORITY||Mean Difference (Net)|-9.98|||<|0.001|TWO_SIDED|95.0|-14.03|-5.93|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-5.93|-14.03|<0.001
91585040|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.5||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.500
91585041|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<.001
91647198|NCT02149199|183185890|SUPERIORITY||Mean Difference (Net)|10.94|||<|0.001|TWO_SIDED|95.0|6.99|14.9|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||14.90|6.99|<0.001
91647199|NCT02149199|183185890|SUPERIORITY||Mean Difference (Net)|-6.23||||0.002|TWO_SIDED|95.0|-10.18|-2.29|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-2.29|-10.18|0.002
91647200|NCT02149199|183185892|SUPERIORITY||Mean Difference (Net)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.18|-0.06|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.06|-0.18|<0.001
91708662|NCT02384538|183310258|OTHER||LS Mean Difference|1.52||||0.386|TWO_SIDED|95.0|-1.944|4.99||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||||4.990|-1.944|0.386
91585042|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.001
91585043|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
91647201|NCT02149199|183185892|SUPERIORITY||Mean Difference (Net)|0.09||||0.004|TWO_SIDED|95.0|0.03|0.15|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.15|0.03|0.004
91647202|NCT02149199|183185899|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|0.001|TWO_SIDED|95.0|0.343|0.497|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||0.497|0.343|<0.001
91647203|NCT02149199|183185899|SUPERIORITY||Hazard Ratio (HR)|0.865||||0.175|TWO_SIDED|95.0|0.701|1.067|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||1.067|0.701|0.175
91585044|NCT06020118|183061129|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
91647204|NCT02149199|183185900|SUPERIORITY||Mean Difference (Net)|-0.154|||<|0.001|TWO_SIDED|95.0|-0.203|-0.105|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.105|-0.203|<0.001
91778395|NCT02978781|183438096|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.845||0.4567|TWO_SIDED|95.0|-2.7|1.36|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.36|-2.70|0.4567
91778396|NCT02978781|183438097|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.85||0.3771|TWO_SIDED|95.0|-2.48|0.96|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.96|-2.48|0.3771
91778397|NCT02978781|183438098|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.415||0.7302|TWO_SIDED|95.0|-0.97|0.69|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.69|-0.97|0.7302
91778398|NCT02978781|183438098|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.467||0.7916|TWO_SIDED|95.0|-1.1|0.85|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.85|-1.10|0.7916
91778399|NCT02978781|183438099|SUPERIORITY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.34||0.1807|TWO_SIDED|95.0|-1.17|0.23|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.23|-1.17|0.1807
91778400|NCT02978781|183438100|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8709|TWO_SIDED|95.0|-1.7|1.9|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline(SAGE-217 - placebo)|Change from Baseline in Archimedes Spirals (AS) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.9|-1.7|0.8709
91778401|NCT02978781|183438100|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.7843|TWO_SIDED|95.0|-1.8|1.4|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo)|Change from Baseline in Handwriting at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.4|-1.8|0.7843
91778402|NCT02978781|183438100|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.984||0.7604|TWO_SIDED|95.0|-2.72|2.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo|Change from Baseline in Dot approximation task (DAT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.10|-2.72|0.7604
91778403|NCT02978781|183438101|OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.1333|TWO_SIDED|95.0|-1.13|0.17|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.17|-1.13|0.1333
91585045|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.894||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.894
91585046|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.104||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.104
91585047|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.815||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.815
91585048|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.814||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.814
91585049|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<0.001
91585050|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||<0.001
91585051|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
91585052|NCT06020118|183061130|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
91585053|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.699||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.699
91585054|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.88||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||0.880
91585055|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.72||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.720
91585056|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.238||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H3N2)||||0.238
91585057|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.28||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.280
91585058|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.094||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||0.094
91585059|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.216||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.216
91585060|NCT06020118|183061131|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.||||||0.436||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||0.436
91585061|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.615||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.615
91647205|NCT02149199|183185900|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.198|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||0.198|0.101|<0.001
91585062|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||<0.001
91647206|NCT02149199|183185901|SUPERIORITY||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.074|0.181|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||0.181|0.074|<0.001
91585063|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.87||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.870
91585064|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001|||||||Regression, Linear|GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.||Post-vaccine: Antigen A(H3N2)||||<0.001
91585065|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.64||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.640
91585066|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||<0.001
91585067|NCT06020118|183061131|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.444||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.444
91585068|NCT06020118|183061131|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||<0.001
91585069|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.793||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||0.793
91585070|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.326||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||0.326
91585071|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.933||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||0.933
91585072|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.424||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||0.424
91585073|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||<0.001
91585074|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||<0.001
91585075|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||<0.001
91585076|NCT06020118|183061132|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||<0.001
91585077|NCT01281969|183061144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97||||0.44|TWO_SIDED|95.0|-7.1|3.15||p-value is unadjusted. a priori threshold for statistical significance is .05|ANCOVA|F(1,34)=0.62, p=.44||Analysis of covariance model controlling for baseline scores. A priori power calculations based on the Perlmutter et al. study (IVIG effect size 1.2) suggested that a sample size of 16 per group would be sufficient to detect an effect size of 1.0 with 80% power.||3.15|-7.1|0.44
91585078|NCT01281969|183061145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||p-value is not adjusted.|Wilcoxon (Mann-Whitney)|Mean rank sum in the placebo group = 19.92; mean rank sum in the IVIG group = 15.97. Z = -1.18, p=.12||The Wilcoxon two-sample test was used to compare CGI-Improvement ratings (an ordinal variable) at week 6. Power calculation was based on CYBOCS as primary outcome.||||.12
91647207|NCT02149199|183185901|SUPERIORITY||Mean Difference (Net)|-0.102|||<|0.001|TWO_SIDED|95.0|-0.155|-0.049|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.049|-0.155|<0.001
91585079|NCT01281969|183061146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||p-value is not adjusted for multiple comparisons.|Chi-squared|X2 = 0.72, p=.40||Chi-squared test was used to compare distribution of responders by randomization group. Power calculation was based on CY-BOCS (primary outcome).||||.40
91708663|NCT02384538|183310260|OTHER||LS Mean Difference|2.55||||0.383|TWO_SIDED|95.0|-3.214|8.308||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||8.308|-3.214|0.383
91585080|NCT01296347|183061158|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91585081|NCT01296347|183061159|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||6 weeks||||0.71
91585082|NCT01296347|183061159|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||3 month||||1.0
91585083|NCT01296347|183061159|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||6 months||||0.32
91585084|NCT01296347|183061161|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91585085|NCT01296347|183061162|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91585086|NCT01296347|183061163|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91585087|NCT01296347|183061164|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91647208|NCT02149199|183185903|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.27|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.27|<0.001
91585088|NCT02240693|183061165|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.075||0.3236|TWO_SIDED|95.0|-0.074|0.223||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.223|-0.074|0.3236
91585089|NCT02240693|183061165|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.076||0.3694|TWO_SIDED|95.0|-0.22|0.082||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.082|-0.220|0.3694
91585090|NCT02240693|183061165|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.8374|TWO_SIDED|95.0|-0.171|0.139||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.139|-0.171|0.8374
91585091|NCT02240693|183061165|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.077||0.5484|TWO_SIDED|95.0|-0.106|0.199||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.199|-0.106|0.5484
91585092|NCT02240693|183061165|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.054||0.7905|TWO_SIDED|95.0|-0.092|0.121||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.121|-0.092|0.7905
91585093|NCT02240693|183061166|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.102||0.8973|TWO_SIDED|95.0|-2.33|2.04||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|2.04|-2.33|0.8973
91585094|NCT02240693|183061166|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.122||0.2141|TWO_SIDED|95.0|-0.82|3.63||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|3.63|-0.82|0.2141
91585095|NCT02240693|183061166|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.085||0.6553|TWO_SIDED|95.0|-2.64|1.67||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.67|-2.64|0.6553
91585096|NCT02240693|183061166|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.144||0.7166|TWO_SIDED|95.0|-1.85|2.69||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|2.69|-1.85|0.7166
91647209|NCT02149199|183185903|SUPERIORITY||Rate ratio|0.83||||0.279|TWO_SIDED|95.0|0.59|1.16|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||1.16|0.59|0.279
91585097|NCT02240693|183061167|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9491|TWO_SIDED|95.0|-0.49|0.46||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.46|-0.49|0.9491
91585098|NCT02240693|183061167|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1699|TWO_SIDED|95.0|-0.15|0.84||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.84|-0.15|0.1699
91585099|NCT02240693|183061167|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4948|TWO_SIDED|95.0|-0.69|0.33||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.33|-0.69|0.4948
91647210|NCT02149199|183185904|SUPERIORITY||Rate ratio|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.32|<0.001
91778404|NCT02978781|183438101|OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0572|TWO_SIDED|95.0|-1.64|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-1.64|0.0572
91778405|NCT02978781|183438101|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.255||0.0707|TWO_SIDED|95.0|-1.05|0.05|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.05|-1.05|0.0707
91778406|NCT02978781|183438102|OTHER||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.628||0.0278|TWO_SIDED|95.0|-2.87|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-2.87|0.0278
91778407|NCT02978781|183438103|OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.258||0.9579|TWO_SIDED|95.0|-0.57|0.54|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.54|-0.57|0.9579
91778408|NCT02978781|183438103|OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.234||0.0039|TWO_SIDED|95.0|-1.31|-0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.30|-1.31|0.0039
91778409|NCT02978781|183438103|OTHER||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.223||0.0099|TWO_SIDED|95.0|-1.14|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-1.14|0.0099
91778410|NCT02978781|183438104|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1595|TWO_SIDED|95.0|-1.5|0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Archimedes spirals (AS) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.3|-1.5|0.1595
91778411|NCT02978781|183438104|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0126|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Handwriting at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.1|-0.9|0.0126
91778412|NCT02978781|183438104|OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.151||0.1536|TWO_SIDED|95.0|-0.55|0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Dot approximation task (DAT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.10|-0.55|0.1536
91778413|NCT01383356|183438113|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (GMR) in percent|118.0|||||TWO_SIDED|90.0|111.0|125.0|||||Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||125|111|
91585100|NCT02240693|183061167|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.7548|TWO_SIDED|95.0|-0.42|0.58||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.58|-0.42|0.7548
91647211|NCT02149199|183185904|SUPERIORITY||Rate ratio|0.95||||0.663|TWO_SIDED|95.0|0.74|1.21|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||1.21|0.74|0.663
91585101|NCT02240693|183061168|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.081||0.8137|TWO_SIDED|95.0|-2.4|1.89||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.89|-2.40|0.8137
91585102|NCT02240693|183061168|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.12||0.5801|TWO_SIDED|95.0|-2.84|1.6||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.60|-2.84|0.5801
91585103|NCT02240693|183061168|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.072||0.2978|TWO_SIDED|95.0|-3.25|1.0||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.00|-3.25|0.2978
91585104|NCT02240693|183061168|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|1.072||0.0209|TWO_SIDED|95.0|-4.64|-0.39||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|-0.39|-4.64|0.0209
91585105|NCT02240693|183061169|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.120|-0.101|0.8694
91585106|NCT02240693|183061169|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.109|-0.116|0.9512
91585107|NCT02240693|183061169|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.115|-0.105|0.9321
91647212|NCT01083901|183185998|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|Changes from baseline to 16 weeks were regressed on the baseline measurement.||The null hypothesis was that the changes in total body fat-free mass in response to resistance exercise training would not be different among the groups. The expected difference in fat-free mass between the Acetaminophen and Placebo groups was 1.8 +/- 1.0% with a 3.6 +/1 1.0% increase in fat-free mass in the Placebo group. The study was designed to achieve 96% power at the 0.05 level with 10 men in the acetaminophen and placebo groups.||||0.38
91647213|NCT01083901|183185999|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|The change in fat mass was regressed on the baseline measure.||||||0.23
91647214|NCT01083901|183186000|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANCOVA|Change in strength was regressed on baseline measures.||||||0.30
91647215|NCT01083901|183186001|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|Changes in strength were regressed on the baseline measure.||||||0.37
91647216|NCT00563524|183186037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5237|||||||ANCOVA|||Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.5237
91778414|NCT01383356|183438113|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|122.0|||||TWO_SIDED|90.0|114.0|130.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).||130|114|
91585108|NCT02240693|183061169|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.025|-0.199|0.1288
91585109|NCT02240693|183061169|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.061|-0.098|0.6492
91585110|NCT02668185|183061185|SUPERIORITY|Generalised linear mixed model with a Poisson error structure|Mean Difference (Net)|29.66|||<|0.0001|TWO_SIDED|95.0|17.39|42.87||Intention to treat adjusted means.|generalised linear mixed model with a Po|Adjusted for intention to treat||||42.87|17.39|<0.0001
91585111|NCT02668185|183061186|SUPERIORITY||Mean Difference (Net)|50.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91585112|NCT02668185|183061187|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91647217|NCT00563524|183186037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8463|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.8463
91647218|NCT00563524|183186037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4596|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4596
91647219|NCT00563524|183186037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6345|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6345
91647220|NCT00563524|183186037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6235|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6235
91647221|NCT00563524|183186038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3833|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.3833
91647222|NCT00563524|183186038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4909|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4909
91647223|NCT00563524|183186038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.2200
91585113|NCT02668185|183061188|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91585114|NCT02668185|183061189|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91585115|NCT01013597|183061194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||t-test, 2 sided|||||||0.98
91647224|NCT00563524|183186038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4183|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4183
91585116|NCT02678247|183061197|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED|95.0|0.8|2.3||alpha = 0.05|t-test, 2 sided|paired t-test||||2.3|0.8|<0.001
91647225|NCT00563524|183186038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.465|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4650
91647226|NCT00563524|183186039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7051|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.7051
91647227|NCT00563524|183186039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1072|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.1072
91778415|NCT01383356|183438114|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
91778416|NCT01383356|183438114|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
91778417|NCT01383356|183438115|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE), AUC0-inf was no BE criteria|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
91778418|NCT01383356|183438115|NON_INFERIORITY_OR_EQUIVALENCE|BE, AUC0-inf was no BE criteria|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
91778419|NCT02054104|183438121|OTHER|||||||0.36|||||||Mann-Whitney U test|||||||0.36
91778420|NCT00084136|183438135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||<|0.01|TWO_SIDED|95.0|1.12|2.04||Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Log Rank|Log-rank test was stratified by country and screening RNA (\< 100,000 c/mL vs \>= 100,000 copies/mL).|The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.|||2.04|1.12|<0.01
91778421|NCT00084136|183438136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.72|1.27|||Other||The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.|While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.||1.27|0.72|
91778422|NCT02633306|183438162|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91647228|NCT00563524|183186039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0020
91647229|NCT00563524|183186039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0079
91647230|NCT00563524|183186039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0308|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0308
91778423|NCT02633306|183438163|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91585117|NCT02678247|183061198|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.1||0.664|TWO_SIDED|95.0|-0.06|0.04||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.04|-0.06|0.664
91585118|NCT02678247|183061199|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|3.05||0.026|TWO_SIDED|95.0|-3.17|-0.23||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||-0.23|-3.17|0.026
91585119|NCT02678247|183061200|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|4.58||0.847|TWO_SIDED|95.0|-2.0|2.42||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||2.42|-2|0.847
91585120|NCT02678247|183061201|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_DEVIATION|2.87|<|0.017|TWO_SIDED|95.0|-2.42|0.34||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.34|-2.42|<0.017
91585121|NCT02678247|183061202|OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.58||0.7|TWO_SIDED|95.0|-0.53|0.77||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||0.77|-0.53|0.7
91647231|NCT01467570|183186047|NON_INFERIORITY_OR_EQUIVALENCE|The differences between study groups were considered significant when the p value was \<0.05 or when the 95% CI for RD or MD did not include 0 (equivalent to p \< 0.05).||||||0.28|||||||t-test, 1 sided|||||||0.28
91521179|NCT02954354|182917033|SUPERIORITY|||||||0.9453||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.9453
91647232|NCT03712137|183186057|SUPERIORITY||Responder Rate Difference|30.9||||0.0001|TWO_SIDED|95.0|15.33|46.54|||Multiple Imputation|The procedure used to perform Multiple Imputation is PROC MIANALYZE in SAS with normal approximation||||46.54|15.33|0.0001
91647233|NCT03712137|183186060|SUPERIORITY||Mean Difference (Final Values)|45.9|||<|0.0001|TWO_SIDED|95.0|40.45|51.28|||Paired T-test|||||51.28|40.45|<0.0001
91585122|NCT02678247|183061203|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_DEVIATION|8.9||0.2|TWO_SIDED|95.0|-1.6|7.0||alpha = 0.05|t-test, 2 sided|paired t-test||||7.0|-1.6|0.20
91585123|NCT02678247|183061204|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|10.0||0.62|TWO_SIDED|95.0|-6.0|3.7||alpha = 0.05|t-test, 2 sided|paired t-test||||3.7|-6.0|0.62
91521180|NCT02954354|182917033|SUPERIORITY|||||||0.8657||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.8657
91585124|NCT02678247|183061205|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|5.7||0.07|TWO_SIDED|95.0|-0.2|5.3||alpha = 0.05|t-test, 2 sided|paired t-test||||5.3|-0.2|0.07
91647234|NCT01222715|183186066|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED|95.0|||||Log Rank|||The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.||||0.0124
91585125|NCT02678247|183061206|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.3||0.18|TWO_SIDED|95.0|-5.4|1.1||alpha = 0.05|t-test, 2 sided|paired t-test||||1.1|-5.4|0.18
91585126|NCT02678247|183061207|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.3||0.47|TWO_SIDED|95.0|-0.4|0.9||alpha = 0.05|t-test, 2 sided|paired t-test||||0.9|-0.4|0.47
91585127|NCT02678247|183061208|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.5||0.68|TWO_SIDED|95.0|-1.4|2.0||alpha = 0.05|t-test, 2 sided|paired t-test||||2.0|-1.4|0.68
91585128|NCT00081497|183061259|SUPERIORITY_OR_OTHER||Change in Slope Mean|-0.029||||0.013||95.0|-0.051|-0.007|||Mixed Models Analysis|Mixed effects model with a population level (fixed effect) intercept and slope and a subject level (random effect) intercept and slope.||The statistical analysis represents the primary outcome measure results.||-0.007|-0.051|0.0130
91585129|NCT00081497|183061260|SUPERIORITY_OR_OTHER||Mean Difference|-6.787||||0.0027||95.0|-11.123|-2.45|||Mixed Effects Model|||Statistical Analysis 1 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup \>60.||-2.450|-11.123|0.0027
91585130|NCT00081497|183061260|SUPERIORITY_OR_OTHER||Mean Difference|2.33||||0.1268||95.0|-0.685|5.345|||Mixed Effects Model|||Statistical Analysis 2 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup ≤ 60.||5.345|-0.685|0.1268
91585131|NCT03081052|183061269|EQUIVALENCE|We estimated sample size based on equivalence test of the incidence rates of a binary outcome (e.g. PGD grade 3 (PGD-3)) of two treatment groups as an illustration. Assuming the incidence rate of PGD-3 under iEPO treatment is 0.30 and acceptable margin of the equivalence is ± 0.19, we will need 200 lung transplant patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.049||||0.019|TWO_SIDED|90.0|-0.064|0.162|||two one sided test p-value|||||0.162|-0.064|0.019
91585132|NCT03081052|183061270|NON_INFERIORITY|We estimated sample size based on equivalence test of the incidence rates of a binary outcome of two treatment groups as an illustration. Assuming the incidence rate of moderate or severe RV failure under iEPO treatment is 0.113 and acceptable margin of the equivalence is ± 0.15, we will need 224 heart failure patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.025||||0.012|TWO_SIDED|90.0|-0.066|0.116|||two one-sided test p-value|||||0.116|-0.066|0.012
91585133|NCT03081052|183061271|OTHER||Hodges-Lehmann Location Shift|0.0||||0.747|TWO_SIDED|95.0|-3.0|3.0|||Log Rank|||||3|-3|0.747
91585134|NCT03081052|183061271|OTHER||Hodges-Lehmann Location Shift|0.0||||0.638|TWO_SIDED|95.0|-1.0|1.0|||Log Rank|||||1|-1|0.638
91585135|NCT03081052|183061273|OTHER||mean ratio|1.19||||0.453|TWO_SIDED|95.0|0.76|1.87|||log-linear regression|||||1.87|0.76|0.453
91585136|NCT03081052|183061273|OTHER||mean ratio|0.94||||0.816|TWO_SIDED|95.0|0.57|1.56|||log-linear regression|||||1.56|0.57|0.816
91585137|NCT03081052|183061274|OTHER||mean ratio|1.03||||0.864|TWO_SIDED|95.0|0.75|1.41|||log-linear regression|||||1.41|0.75|0.864
91585138|NCT03081052|183061274|OTHER||mean ratio|0.97||||0.825|TWO_SIDED|95.0|0.73|1.28|||log-linear regression|||||1.28|0.73|0.825
91647235|NCT03964220|183186189|OTHER||Hazard Ratio (HR)|0.65||||0.044|TWO_SIDED|95.0|0.427|0.99|||Regression, Cox|||The time to first exacerbation was analysis using Cox Proportional Hazards model with group status as the only independent variable assessing the risk of exacerbation across Tio and NonTio groups.||0.990|0.427|0.044
91647236|NCT03964220|183186190|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up.||||< 0.0001
91585139|NCT03081052|183061275|OTHER||Odds Ratio (OR)|1.43||||0.251|TWO_SIDED|95.0|0.78|2.61|||Chi-squared|||||2.61|0.78|0.251
91585140|NCT03081052|183061275|OTHER||Odds Ratio (OR)|1.2||||0.619|TWO_SIDED|95.0|0.58|2.5|||Chi-squared|||||2.5|0.58|0.619
91647237|NCT03964220|183186190|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up.||||< 0.0001
91647238|NCT00467818|183186243|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
91647239|NCT00467818|183186244|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
91585141|NCT03081052|183061277|OTHER||Odds Ratio (OR)|2.13||||0.614|TWO_SIDED|95.0|0.19|23.82|||Fisher Exact|||||23.82|0.19|0.614
91585142|NCT03081052|183061277|OTHER||Odds Ratio (OR)|0.6||||0.5424|TWO_SIDED|95.0|0.17|2.12|||Fisher Exact|||||2.12|0.17|0.5424
91585143|NCT02425644|183061284|SUPERIORITY||Rate ratio|0.695||||0.0003|TWO_SIDED|99.0|0.536|0.902|||Negative binomial regression model|||||0.902|0.536|0.0003
91585144|NCT02425644|183061285|SUPERIORITY||Mean Difference (Final Values)|-3.57||||0.0019|TWO_SIDED|95.0|-5.83|-1.32|||Mixed Models Analysis|||||-1.32|-5.83|0.0019
91585145|NCT02425644|183061286|SUPERIORITY||Rate Ratio|0.444|||<|0.0001|TWO_SIDED|95.0|0.364|0.542|||Negative binomial regression model|||||0.542|0.364|<.0001
91585146|NCT02425644|183061287|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.2939|TWO_SIDED|95.0|0.58|1.18|||Log Rank|||||1.18|0.58|0.2939
91585147|NCT02425644|183061288|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.372|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3720
91585148|NCT00567268|183061313|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.004|||||||Fisher Exact|||"The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin."||||=0.004
91585149|NCT00567268|183061314|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Fisher Exact|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
91585150|NCT00567268|183061314|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Cochran-Armitage|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
91585151|NCT00567268|183061315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no difference between \<65 years and \>=65 years in the number of participants who responded to the treatment with gabapentin."||||<0.001
91585152|NCT00567268|183061316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin."||||<0.001
91647240|NCT00467818|183186246|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.5|TWO_SIDED||||||Mixed Models Analysis|||||||<0.5
91585153|NCT00567268|183061316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was age. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories."||||<0.001
91647241|NCT00467818|183186247|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.5
91778424|NCT02633306|183438164|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91778425|NCT02633306|183438165|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91778426|NCT02633306|183438166|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91778427|NCT02633306|183438167|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91778428|NCT02633306|183438168|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
91778429|NCT00089752|183438174|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was designed to achieve at least 80% power, using n 1⁄4 123 per group with an effect size of at least 0.36|Adjusted difference in mean change|-1.76||||0.09|TWO_SIDED|95.0|-3.8|0.3||a priori threshold was p\<0.05|ANCOVA|||Intent to Treat analysis with Last Observation Carried Forward.||0.3|-3.8|0.09
91778430|NCT03879772|183438192|SUPERIORITY|||||||0.95|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).||||0.95
91778431|NCT03879772|183438192|SUPERIORITY|||||||0.78|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.78
91778432|NCT03879772|183438192|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
91778433|NCT03879772|183438192|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
91778434|NCT03879772|183438192|SUPERIORITY|||||||0.82|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.82
91778435|NCT03879772|183438192|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
91778436|NCT03879772|183438192|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
91778437|NCT03879772|183438192|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
91778438|NCT03879772|183438192|SUPERIORITY|||||||0.02|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.02
91778439|NCT03879772|183438192|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
91585154|NCT00567268|183061317|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|||||||Chi-squared|||"The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||=0.008
91778440|NCT03879772|183438193|SUPERIORITY|||||||0.56|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.56
91778441|NCT03879772|183438193|SUPERIORITY|||||||0.74|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.74
91778442|NCT03879772|183438193|SUPERIORITY|||||||0.68|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.68
91778443|NCT03879772|183438193|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778444|NCT03879772|183438193|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
91778445|NCT03879772|183438193|SUPERIORITY|||||||0.33|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.33
91778446|NCT03879772|183438193|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
91778447|NCT03879772|183438193|SUPERIORITY|||||||0.46|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.46
91778448|NCT03879772|183438193|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778449|NCT03879772|183438193|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778450|NCT03879772|183438194|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
91778451|NCT03879772|183438194|SUPERIORITY|||||||0.45|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.45
91778452|NCT03879772|183438194|SUPERIORITY|||||||0.12|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.12
91778453|NCT03879772|183438194|SUPERIORITY|||||||0.36|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.36
91778454|NCT03879772|183438194|SUPERIORITY|||||||0.6|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.6
91521181|NCT02954354|182917034|SUPERIORITY|||||||0.0458||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.0458
91585155|NCT00567268|183061317|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|||||||Cochran-Armitage|||"The factor tested was severity of partial epileptic seizure. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe)."||||=0.002
91585156|NCT00567268|183061318|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.018|||||||Chi-squared|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||=0.018
91585157|NCT00567268|183061319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||<0.001
91585158|NCT00567268|183061319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||<0.001
91585159|NCT00567268|183061320|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.025|||||||Cochran-Armitage|||"The factor tested was baseline creatinine clearance. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the baseline creatinine clearance."||||=0.025
91585160|NCT00567268|183061321|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.043|||||||Chi-squared|||"The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin."||||=0.043
91585161|NCT02525861|183061327|OTHER||Geometric Mean Ratio|5.398|||<|0.001|||||||Mixed-effects model|||Statistical analysis was collected and assessed based on A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
91585162|NCT02525861|183061328|OTHER||Geometric Mean Ratio|2.259|||<|0.001|||||||mixed-effects model|||Statistical analysis was collected and assessed based on functional A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
91585163|NCT01942720|183061336|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|-0.7||||0.631|TWO_SIDED||||||Sperman test|||Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up||||0.631
91585164|NCT01942720|183061336|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|0.022||||0.882|TWO_SIDED||||||Sperman correlation|||Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up||||0.882
91585165|NCT01942720|183061337|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.735|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit||||<0.001
91585166|NCT01942720|183061337|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit||||<0.001
91585167|NCT01942720|183061338|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.493||||0.002|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up||||0.002
91585168|NCT01942720|183061338|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.531|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up||||<0.001
91585169|NCT01942720|183061339|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.752|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
91647242|NCT02216214|183186262|SUPERIORITY||Least Squares Mean (LSM) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.33||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.33|-1.05|<0.001
91778455|NCT03879772|183438194|SUPERIORITY|||||||0.17|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.17
91585170|NCT01942720|183061339|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.785|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
91585171|NCT00511472|183061382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|STANDARD_ERROR_OF_MEAN|14.15||0.001|TWO_SIDED|90.0|22.71|69.5|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-Breakfast for Titration Group 1||69.50|22.71|0.001
91585172|NCT00511472|183061382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.28|STANDARD_ERROR_OF_MEAN|13.67|<|0.001|TWO_SIDED|90.0|27.68|72.88|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2||72.88|27.68|<0.001
91585173|NCT00446992|183061384|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||<0.001
91585174|NCT00446992|183061385|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||.043
91585175|NCT00446992|183061386|SUPERIORITY_OR_OTHER||||||=|0.69|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.690
91585176|NCT00446992|183061387|SUPERIORITY_OR_OTHER||||||=|0.691|TWO_SIDED||||||Intervariate|||Baseline compared to Week 16||||= 0.691
91585177|NCT00446992|183061388|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.877
91585178|NCT00446992|183061389|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.003
91585179|NCT00446992|183061390|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= .005
91585180|NCT00446992|183061391|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.696
91647243|NCT02216214|183186263|SUPERIORITY||LSM Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.82|-0.27||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.27|-0.82|<0.001
91585181|NCT00446992|183061392|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.013
91613912|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.963|||<|0.0001|TWO_SIDED|95.0|0.956|0.97|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.956|<0.0001
91647244|NCT02216214|183186264|SUPERIORITY||LSM Difference|13.68|STANDARD_ERROR_OF_MEAN|4.45||0.002|TWO_SIDED|95.0|4.95|22.42||P-value compares the Mirabegron group to the placebo group.|stratified rank ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||22.42|4.95|0.002
91647245|NCT02216214|183186265|SUPERIORITY||LSM Difference|-5.15|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|95.0|-7.84|-2.46||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-2.46|-7.84|<0.001
91647246|NCT02216214|183186266|SUPERIORITY||LSM Difference|2.72|STANDARD_ERROR_OF_MEAN|1.07||0.011|TWO_SIDED|95.0|0.62|4.83||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||4.83|0.62|0.011
91778456|NCT03879772|183438194|SUPERIORITY|||||||0.23|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.23
91778457|NCT03879772|183438194|SUPERIORITY|||||||0.42|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.42
91778458|NCT03879772|183438194|SUPERIORITY|||||||0.09|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.09
91778459|NCT03879772|183438194|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
91778460|NCT03879772|183438195|SUPERIORITY|||||||0.03|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.03
91778461|NCT03879772|183438195|SUPERIORITY|||||||0.04|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.04
91778462|NCT03879772|183438195|SUPERIORITY|||||||0.08|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.08
91778463|NCT03879772|183438195|SUPERIORITY|||||||0.49|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.49
91778464|NCT03879772|183438195|SUPERIORITY|||||||0.93|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.93
91778465|NCT03879772|183438195|SUPERIORITY|||||||0.75|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.75
91778466|NCT03879772|183438195|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778467|NCT03879772|183438195|SUPERIORITY|||||||0.71|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.71
91778468|NCT03879772|183438195|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778469|NCT03879772|183438195|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
91778470|NCT03879772|183438196|SUPERIORITY|||||||0.16|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.16
91778471|NCT03879772|183438196|SUPERIORITY|||||||0.22|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.22
91778472|NCT03879772|183438196|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
91778473|NCT03879772|183438196|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
91778474|NCT03879772|183438196|SUPERIORITY|||||||0.85|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.85
91778475|NCT03879772|183438196|SUPERIORITY|||||||0.96|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.96
91778476|NCT03879772|183438196|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778477|NCT03879772|183438196|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
91778478|NCT03879772|183438196|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778479|NCT03879772|183438196|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778480|NCT03879772|183438197|SUPERIORITY|||||||0.05|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.05
91778481|NCT03879772|183438197|SUPERIORITY|||||||0.07|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.07
91778482|NCT03879772|183438197|SUPERIORITY|||||||0.11|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.11
91778483|NCT03879772|183438197|SUPERIORITY|||||||0.31|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.31
91585182|NCT00406653|183061393|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.611|TWO_SIDED|95.0|0.6|2.4||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, \~10mg/kg, 30/\~10mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/\~10 mg/kg=45%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/\~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||2.4|0.6|0.611
91778484|NCT03879772|183438197|SUPERIORITY|||||||0.94|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.94
91778485|NCT03879772|183438197|SUPERIORITY|||||||0.73|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.73
91778486|NCT03879772|183438197|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778487|NCT03879772|183438197|SUPERIORITY|||||||0.79|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.79
91778488|NCT03879772|183438197|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778489|NCT03879772|183438197|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
91778490|NCT04916587|183438332|SUPERIORITY||Risk Difference (RD)|11.6|||||TWO_SIDED|95.0|10.6|12.6||||||||12.6|10.6|
91521182|NCT02954354|182917034|SUPERIORITY|||||||0.7565||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.7565
91778491|NCT04916587|183438333|SUPERIORITY||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|6.6|8.3||||||||8.3|6.6|
91778492|NCT04916587|183438334|SUPERIORITY||Odds Ratio (OR)|0.36||||0.03|TWO_SIDED|90.0|0.14|0.89|||Mixed Models Analysis|||||0.89|0.14|0.03
91790184|NCT02660138|183459523|OTHER|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|10.7|||<|0.0001|TWO_SIDED|95.0|4.59|24.95||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 600 U versus Placebo.||24.95|4.59|<0.0001
91585183|NCT00406653|183061396|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.4|3.44||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA mg/kg, \~10 mg/kg, 30/\~10 mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=80%, sample size=134, 5% significance; expected PLA response rate= 15%, ABA/\~10 mg/kg=30%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/\~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||3.44|0.4|
91585184|NCT00406653|183061397|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.436
91708664|NCT02384538|183310261|OTHER||LS Mean Difference|0.15||||0.719|TWO_SIDED|95.0|-0.677|0.979||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||0.979|-0.677|0.719
91778493|NCT04672239|183438367|SUPERIORITY||Mean Difference (Final Values)|7.3341||||0.0219|TWO_SIDED|95.0|1.0734|13.5948||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||13.5948|1.0734|0.0219
91778494|NCT04672239|183438367|SUPERIORITY||Mean Difference (Final Values)|8.7775||||0.0072|TWO_SIDED|95.0|2.407|15.148||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||15.1480|2.4070|0.0072
91778495|NCT04672239|183438368|SUPERIORITY||Odds Ratio (OR)|1.5072||||0.2259|TWO_SIDED|95.0|0.7759|2.9281|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the QG app treatment at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the QuitGuide app treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., end-of-treatment).||2.9281|0.7759|0.2259
91778496|NCT04672239|183438368|SUPERIORITY||Odds Ratio (OR)|1.963||||0.0579|TWO_SIDED|95.0|0.9776|3.9415|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the CtA pamphlet at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the Clearing the Air pamphlet treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., post-treatment).||3.9415|0.9776|0.0579
91778497|NCT04672239|183438369|SUPERIORITY||Wilcoxon Z|0.401||||0.9152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app treatment vs. QuitGuide app treatment at week 6 post-quit (end-of-treatment)|||||0.9152
91778498|NCT04672239|183438369|SUPERIORITY||Wilcoxon Z|1.372||||0.3557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|Pairwise comparison, SiS app treatment vs. CTA pamphlet at week 6 post-quit (end-of-treatment)|||||0.3557
91778499|NCT04672239|183438370|SUPERIORITY||Mean Difference (Final Values)|0.2936||||0.7469|TWO_SIDED|95.0|-1.4983|2.0856||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the QuitGuide treatment as control (Contrast coding SiS 1, QG -1)|||2.0856|-1.4983|0.7469
91778500|NCT04672239|183438370|SUPERIORITY||Mean Difference (Final Values)|1.2569||||0.1747|TWO_SIDED|95.0|-0.5628|3.0766||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the Clearing the Air pamphlet treatment as control (Contrast coding SiS 1, CtA -1)|||3.0766|-0.5628|0.1747
91778501|NCT04672239|183438371|SUPERIORITY||Wilcoxon Z|1.9255||||0.1315|TWO_SIDED|||||p-values were not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method||||||0.1315
91778502|NCT04672239|183438371|SUPERIORITY||Wilcoxon Z|1.401||||0.3403|TWO_SIDED|||||the p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app vs. Clearing the Air pamphlet|||||0.3403
91778503|NCT04672239|183438372|SUPERIORITY||Mean Difference (Final Values)|0.2289||||0.0429|TWO_SIDED|95.0|0.007364|0.4505||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app|0.4505|0.007364|0.0429
91585185|NCT00406653|183061404|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.112
91613913|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||<|0.0001|TWO_SIDED|95.0|1.12|1.275|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.275|1.120|<0.0001
91778504|NCT04672239|183438372|SUPERIORITY||Mean Difference (Final Values)|0.1609||||0.16|TWO_SIDED|95.0|-0.06415|0.386||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet|0.3860|-0.06415|0.1600
91778505|NCT04672239|183438373|SUPERIORITY||Mean Difference (Final Values)|0.152||||0.1996|TWO_SIDED|95.0|-0.08092|0.3848||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QG app|0.3848|-0.08092|0.1996
91778506|NCT04672239|183438373|SUPERIORITY||Mean Difference (Final Values)|0.292||||0.0154|TWO_SIDED|95.0|0.05636|0.5276||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|0.5276|0.05636|0.0154
91778507|NCT04672239|183438374|SUPERIORITY||Mean Difference (Final Values)|2.6255||||0.2988|TWO_SIDED|95.0|-2.3458|7.5968||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app (control)|7.5968|-2.3458|0.2988
91778508|NCT04672239|183438374|SUPERIORITY||Mean Difference (Final Values)|3.9277||||0.1251|TWO_SIDED|95.0|-1.1015|8.9569||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|8.9569|-1.1015|0.1251
91778509|NCT04672239|183438375|SUPERIORITY||Wilcoxon Z|-0.8096||||0.4182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4182
91778510|NCT04672239|183438376|SUPERIORITY||Wilcoxon Z|1.909||||0.0563|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0563
91778511|NCT04672239|183438377|SUPERIORITY||Mean Difference (Final Values)|0.1106||||0.5018|TWO_SIDED|95.0|-0.2143|0.4354|||t-test, 2 sided|||||0.4354|-0.2143|0.5018
91778512|NCT04672239|183438378|SUPERIORITY||Mean Difference (Final Values)|0.1406||||0.4246|TWO_SIDED|95.0|-0.2068|0.488|||t-test, 2 sided|||||0.4880|-0.2068|0.4246
91778513|NCT04672239|183438379|SUPERIORITY||Mean Difference (Final Values)|2.4296||||0.4078|TWO_SIDED|95.0|-3.3597|8.2188|||t-test, 2 sided||SiS app vs. QG (control)|||8.2188|-3.3597|0.4078
91778514|NCT04825678|183438399|OTHER||Least squares mean (LSM)|40.72|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|36.05|45.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline monthly migraine days (MMD), and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||45.39|36.05|< 0.001
91647247|NCT02216214|183186267|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.16||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.16|-0.46|<0.001
91778515|NCT04825678|183438399|OTHER||LSM|30.84|STANDARD_ERROR_OF_MEAN|14.53||0.058|TWO_SIDED|95.0|-1.3|62.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||62.98|-1.30|0.058
91778516|NCT04825678|183438400|OTHER||LSM|37.87|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|28.62|47.12||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||47.12|28.62|< 0.001
91778517|NCT04825678|183438400|OTHER||LSM|43.25|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|38.06|48.44||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||48.44|38.06|< 0.001
91778518|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.9|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-49.39|-40.41||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Physical Function Domain||-40.41|-49.39|< 0.001
91585186|NCT00731120|183061422|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.803||0.279|TWO_SIDED|95.0|-2.45|0.71||Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||P-values were tested at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||0.71|-2.45|0.279
91585187|NCT00731120|183061422|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.791||0.306|TWO_SIDED|95.0|-2.36|0.74||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||||0.74|-2.36|0.306
91521183|NCT02954354|182917034|SUPERIORITY|||||||0.3297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.3297
91647248|NCT02216214|183186268|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
91647249|NCT02216214|183186269|SUPERIORITY||Rate Ratio|0.68|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of urgency incontinence episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group was calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||<0.001
91647250|NCT02216214|183186270|SUPERIORITY||Rate Ratio|0.84||||0.432||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of nocturia episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||0.432
91647251|NCT02216214|183186271|SUPERIORITY|||||||0.317||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.317
91778519|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-54.15|STANDARD_ERROR_OF_MEAN|8.43|<|0.001|TWO_SIDED|95.0|-73.43|-34.86||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Physical Function Domain||-34.86|-73.43|< 0.001
91778520|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.35|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.26|-40.44||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Usual Activities Domain||-40.44|-48.26|< 0.001
91778521|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-43.8|STANDARD_ERROR_OF_MEAN|4.47|<|0.001|TWO_SIDED|95.0|-53.51|-34.08||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Usual Activities Domain||-34.08|-53.51|< 0.001
91778522|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.39|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-48.65|-40.14||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Social Function Domain||-40.14|-48.65|< 0.001
91585188|NCT02434939|183061441|NON_INFERIORITY_OR_EQUIVALENCE|a clinically significant difference in validated pain scores was defined as 1.3. assuming both treatments are on average equal, 240 patients provided 95% power to demonstrate that IV low dose ketamine is non inferior to IV morphine with a 0.05 level of significance.|Mean Difference (Final Values)|5.5||||0.18|TWO_SIDED|95.0|-2.2|13.2|||t-test, 2 sided|||||13.2|-2.2|0.18
91778523|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.03|STANDARD_ERROR_OF_MEAN|6.97|<|0.001|TWO_SIDED|95.0|-60.28|-29.79||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Social Function Domain||-29.79|-60.28|< 0.001
91778524|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-50.29|-40.7||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Emotional Function Domain||-40.70|-50.29|< 0.001
91778525|NCT04825678|183438409|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-60.06|STANDARD_ERROR_OF_MEAN|10.98|<|0.001|TWO_SIDED|95.0|-85.16|-34.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Emotional Function Domain||-34.96|-85.16|< 0.001
91778526|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-34.38|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-41.72|-27.03||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Physical Function Domain||-27.03|-41.72|< 0.001
91778527|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-49.56|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-54.44|-44.69||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Physical Function Domain||-44.69|-54.44|< 0.001
91778528|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-35.76|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-41.47|-30.06||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Usual Activities Domain||-30.06|-41.47|< 0.001
91778529|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.7|STANDARD_ERROR_OF_MEAN|2.23|<|0.001|TWO_SIDED|95.0|-51.1|-42.29||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Usual Activities Domain||-42.29|-51.10|< 0.001
91778530|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-36.42|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-42.89|-29.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Social Function Domain||-29.96|-42.89|< 0.001
91778531|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-51.49|-41.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Social Function Domain||-41.98|-51.49|< 0.001
91778532|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-41.44|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-49.47|-33.4||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Emotional Function Domain||-33.40|-49.47|< 0.001
91585189|NCT02434939|183061444|NON_INFERIORITY_OR_EQUIVALENCE|A clinically meaningful difference in validated pain scores was defined as 1.3.Assuming both treatments are on average equal, a sample size of 240 patients (120 per group) provided 95% power to demonstrate that IV LDK is non-inferior to IV morphine with a 0.05 level of significance.||||||0.07|||||||t-test, 2 sided|||||||0.07
91521184|NCT02954354|182917034|SUPERIORITY|||||||0.4442||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||0.4442
91585190|NCT01326533|183061451|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||<0.01
91585191|NCT01326533|183061452|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||0.013
91585192|NCT04079803|183061453|SUPERIORITY|||||||0.087||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0088 and CFB was 13.4. In percent change from baseline with these two subjects removed, P=0.004.|||0.087
91585193|NCT04079803|183061453|SUPERIORITY|||||||0.01||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0006 and CFB was 16.9. In percent change from baseline with this subject removed, P=0.0004.|||0.01
91585194|NCT04079803|183061454|SUPERIORITY||||||<|0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P\<0.0001 and CFB was -19.8.|||<0.0001
91585195|NCT04079803|183061454|SUPERIORITY|||||||0.0012||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.001 and CFB was -14.9.|||0.0012
91585196|NCT04079803|183061455|SUPERIORITY|||||||0.005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.003 and CFB was -3.2.|||0.005
91585197|NCT04079803|183061455|SUPERIORITY|||||||0.002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.003 and CFB was -2.5.|||0.002
91585198|NCT04079803|183061456|SUPERIORITY|||||||0.0002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -681.|||0.0002
91585199|NCT04079803|183061456|SUPERIORITY|||||||0.0005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0005 and CFB was -527.|||0.0005
91613914|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
91778533|NCT04825678|183438410|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-47.67|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-52.95|-42.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Emotional Function Domain||-42.39|-52.95|< 0.001
91778534|NCT01342211|183438411|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-5.63|STANDARD_ERROR_OF_MEAN|9.759||0.5661|TWO_SIDED|95.0|-25.09|13.83|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||13.83|-25.09|0.5661
91778535|NCT01342211|183438411|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|9.422||0.808|TWO_SIDED|95.0|-21.08|16.49|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||16.49|-21.08|0.8080
91778536|NCT01342211|183438411|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.72|STANDARD_ERROR_OF_MEAN|9.404||0.0001|TWO_SIDED|95.0|-56.47|-18.97|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-18.97|-56.47|0.0001
91585200|NCT04079803|183061457|SUPERIORITY|||||||0.0003||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -78.5.|||0.0003
91585201|NCT04079803|183061457|SUPERIORITY|||||||0.0058||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0008 and CFB was -51.0.|||0.0058
91585202|NCT04079803|183061458|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0001 and CFB was -23.7.|||0.0001
91585203|NCT04079803|183061458|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0002 and CFB was -20.9.|||0.0001
91585204|NCT04079803|183061459|OTHER||Effect size|0.23|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
91585205|NCT04079803|183061459|OTHER||Effect size|0.37|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
91585206|NCT04079803|183061460|OTHER||Effect size|0.46|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was almost identical (0.45) when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
91647252|NCT02216214|183186272|SUPERIORITY|||||||0.165||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.165
91647253|NCT02216214|183186273|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
91521185|NCT02954354|182917034|SUPERIORITY|||||||0.6029||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.6029
91647254|NCT02216214|183186274|SUPERIORITY|||||||0.019||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Coping Subscale Score||||0.019
91585207|NCT04079803|183061460|OTHER||Effect size|0.25|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
91585208|NCT04079803|183061461|SUPERIORITY|||||||0.0078||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.0078
91521186|NCT02954354|182917034|SUPERIORITY|||||||0.9881||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.9881
91585209|NCT04079803|183061461|SUPERIORITY|||||||0.019||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.019
91585210|NCT04079803|183061461|SUPERIORITY|||||||0.0002||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0002
91585211|NCT04079803|183061461|SUPERIORITY|||||||0.0007||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0007
91647255|NCT02216214|183186274|SUPERIORITY|||||||0.01||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Concern Subscale Score||||0.010
91585212|NCT04079803|183061461|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
91585213|NCT04079803|183061461|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
91647256|NCT02216214|183186274|SUPERIORITY|||||||0.006||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Sleep Subscale Score||||0.006
91647257|NCT02216214|183186274|SUPERIORITY|||||||0.614||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Social Subscale Score||||0.614
91647258|NCT02216214|183186275|SUPERIORITY|||||||0.002||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.002
91647259|NCT02216214|183186276|SUPERIORITY|||||||0.755||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.755
91521187|NCT02954354|182917034|SUPERIORITY|||||||0.9257||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.9257
91585214|NCT04079803|183061461|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.0001
91708665|NCT02384538|183310262|OTHER||LS Mean Difference|4.25||||0.387|TWO_SIDED|95.0|-5.448|13.945||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||13.945|-5.448|0.387
91778537|NCT01342211|183438411|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.11|STANDARD_ERROR_OF_MEAN|9.514|<|0.0001|TWO_SIDED|95.0|-68.08|-30.14|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-30.14|-68.08|<0.0001
91778538|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172||||0.8998|TWO_SIDED|95.0|0.1|13.92|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||13.92|0.10|0.8998
91778539|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.063||||0.5273|TWO_SIDED|95.0|0.22|19.48|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||19.48|0.22|0.5273
91778540|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.924||||0.0004|TWO_SIDED|95.0|5.93|490.67|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||490.67|5.93|0.0004
91778541|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.366|||<|0.0001|TWO_SIDED|95.0|18.65|4214.35|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||4214.35|18.65|<0.0001
91778542|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.262||||0.086|TWO_SIDED|95.0|0.06|1.21|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.21|0.06|0.0860
91778543|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.4308|TWO_SIDED|95.0|0.15|2.25|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||2.25|0.15|0.4308
91778544|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.272||||0.0127|TWO_SIDED|95.0|1.57|43.56|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.56|1.57|0.0127
91778545|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.528||||0.0096|TWO_SIDED|95.0|1.89|97.0|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||97.00|1.89|0.0096
91778546|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.9519|TWO_SIDED|95.0|0.02|61.54|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||61.54|0.02|0.9519
91778547|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.069||||0.974|TWO_SIDED|95.0|0.02|58.0|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||58.00|0.02|0.9740
91778548|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.286||||0.0273|TWO_SIDED|95.0|1.46|549.78|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||549.78|1.46|0.0273
91778549|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.508||||0.0022|TWO_SIDED|95.0|5.5|2384.03|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||2384.03|5.50|0.0022
91778550|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.216||||0.0684|TWO_SIDED|95.0|0.04|1.12|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.12|0.04|0.0684
91778551|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.081||||0.9068|TWO_SIDED|95.0|0.29|3.99|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||3.99|0.29|0.9068
91778552|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.251||||0.2235|TWO_SIDED|95.0|0.61|8.31|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||8.31|0.61|0.2235
91778553|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25||||0.012|TWO_SIDED|95.0|1.59|42.82|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||42.82|1.59|0.0120
91778554|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.5449|TWO_SIDED|95.0|0.01|9.92|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||9.92|0.01|0.5449
91778555|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.5585|TWO_SIDED|95.0|0.22|16.85|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||16.85|0.22|0.5585
91778556|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.059||||0.0022|TWO_SIDED|95.0|3.0|147.65|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||147.65|3.00|0.0022
91778557|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.851||||0.002|TWO_SIDED|95.0|3.15|165.99|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||165.99|3.15|0.0020
91778558|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.375|TWO_SIDED|95.0|0.48|7.12|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||7.12|0.48|0.3750
91778559|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.914|TWO_SIDED|95.0|0.28|4.23|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||4.23|0.28|0.9140
91778560|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.548||||0.0036|TWO_SIDED|95.0|2.09|43.57|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.57|2.09|0.0036
91778561|NCT01342211|183438412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.093||||0.0149|TWO_SIDED|95.0|1.42|26.1|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||26.10|1.42|0.0149
91778562|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.674||||0.5436|TWO_SIDED|95.0|0.32|8.83|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||8.83|0.32|0.5436
91585215|NCT04079803|183061461|SUPERIORITY|||||||0.046||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.046
91585216|NCT04079803|183061461|SUPERIORITY|||||||0.012||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.012
91585217|NCT04079803|183061461|SUPERIORITY|||||||0.014||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.014
91585218|NCT04079803|183061462|SUPERIORITY|||||||0.005||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as the ratio of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.005
91585219|NCT04079803|183061462|SUPERIORITY|||||||0.009||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as ratios of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.009
91585220|NCT04079803|183061462|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
91708666|NCT02384538|183310263|OTHER||LS Mean Difference|0.45||||0.281|TWO_SIDED|95.0|-0.373|1.272||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.272|-0.373|0.281
91708667|NCT02384538|183310264|OTHER||LS Mean Difference|0.52||||0.212|TWO_SIDED|95.0|-0.3|1.336||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.336|-0.300|0.212
91708668|NCT02872909|183310265|SUPERIORITY||Mean Difference (Final Values)|1.37|||<|0.05|TWO_SIDED|95.0|0.71|2.54||calculated as \<0.05 for 85% power|t-test, 2 sided|Analysed on log transformed data||Sample size requirement estimation - Preliminary data showed pain scores of 1.25 with ambulatory PDT (n=12) and 5.26 (SD 2.38) for conventional PDT (n=50). Estimated that for 85% power to detect as significant at 5% level a difference in mean pain score in one group of 2cm compared with 4 cm in the other group, assuming two-sided testing, a minimum of 45 subjects needed. We aimed for 50 subjects, with an allocation ratio of 2 (twice as many randomised to ambulatory PDT as conventional PDT)||2.54|0.71|<0.05
91778563|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.734||||0.742|TWO_SIDED|95.0|0.12|4.63|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||4.63|0.12|0.7420
91708669|NCT02872909|183310268|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91708670|NCT02187861|183310289|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-13.38|21.23||||||||21.23|-13.38|
91708671|NCT02187861|183310290|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-15.89|19.81||||||||19.81|-15.89|
91708672|NCT02187861|183310291|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-17.07|20.99||||||||20.99|-17.07|
91708673|NCT02187861|183310292|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-27.01|11.32||||||||11.32|-27.01|
91708674|NCT02187861|183310293|SUPERIORITY_OR_OTHER||Difference in response rates|13.73|||||TWO_SIDED|95.0|-4.24|31.69||||||At 6-8 weeks after Cycle 6 Day 1||31.69|-4.24|
91708675|NCT02187861|183310293|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-12.98|20.82||||||At Year 1||20.82|-12.98|
91708676|NCT02187861|183310294|SUPERIORITY_OR_OTHER||Difference in response rates|-15.69|||||TWO_SIDED|95.0|-31.87|0.49||||||At 4-10 weeks after Cycle 6 Day 1||0.49|-31.87|
91708677|NCT02187861|183310294|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-22.56|6.87||||||At Year 1||6.87|-22.56|
91708678|NCT02187861|183310300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.27|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.||1.27|0.38|
91708679|NCT02187861|183310300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.43|1.4|||||HR was calculated using Cox regression.|Unstratified Analysis||1.40|0.43|
91708680|NCT02187861|183310302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.||1.24|0.38|
91708681|NCT02187861|183310302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
91708682|NCT02187861|183310304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.||1.24|0.38|
91708683|NCT02187861|183310304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
91778564|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.151||||0.0002|TWO_SIDED|95.0|4.73|167.62|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||167.62|4.73|0.0002
91778565|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.214||||0.0001|TWO_SIDED|95.0|7.88|643.42|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||643.42|7.88|0.0001
91585221|NCT04079803|183061462|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
91585222|NCT04079803|183061463|SUPERIORITY|||||||0.01|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.01
91585223|NCT04079803|183061463|SUPERIORITY|||||||0.02|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.02
91585224|NCT04079803|183061463|SUPERIORITY|||||||0.009|||||||ANOVA|This p value is for the main effect of treatment of the ANOVA.||||||0.009
91778566|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.203||||0.321|TWO_SIDED|95.0|0.01|4.74|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||4.74|0.01|0.3210
91778567|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.3786|TWO_SIDED|95.0|0.39|12.27|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||12.27|0.39|0.3786
91778568|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.576||||0.0144|TWO_SIDED|95.0|1.5|38.38|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||38.38|1.50|0.0144
91778569|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.465||||0.0007|TWO_SIDED|95.0|3.59|116.6|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||116.60|3.59|0.0007
91778570|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.161||||0.8626|TWO_SIDED|95.0|0.21|6.3|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||6.30|0.21|0.8626
91778571|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.497||||0.6237|TWO_SIDED|95.0|0.3|7.51|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||7.51|0.30|0.6237
91778572|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.029||||0.0072|TWO_SIDED|95.0|1.76|36.65|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||36.65|1.76|0.0072
91778573|NCT01342211|183438413|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.557||||0.0005|TWO_SIDED|95.0|3.73|113.2|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||113.20|3.73|0.0005
91778574|NCT03593044|183438466|OTHER|||||||0.002|||||||t-test, 2 sided|||Photopic pupil size||||0.002
91778575|NCT03593044|183438466|OTHER|||||||0.66|||||||t-test, 2 sided|||Mesopic pupil size||||0.66
91778576|NCT03593044|183438467|OTHER|||||||0.96|||||||t-test, 2 sided|||High contrast distance visual acuity||||0.96
91778577|NCT03593044|183438467|OTHER|||||||0.77|||||||t-test, 2 sided|||High contrast near visual acuity||||0.77
91778578|NCT03593044|183438467|OTHER|||||||0.82|||||||t-test, 2 sided|||Low contrast distance visual acuity||||0.82
91778579|NCT03593044|183438468|OTHER|||||||0.1|||||||t-test, 2 sided|||Accommodative amplitude||||0.10
91778580|NCT03593044|183438468|OTHER|||||||0.66|||||||t-test, 2 sided|||Accommodative lag||||0.66
91778581|NCT03593044|183438468|OTHER|||||||0.24|||||||t-test, 2 sided|||Accommodative facility||||0.24
91778582|NCT03593044|183438469|OTHER|||||||0.3|||||||t-test, 2 sided|||Glare||||0.3
91778583|NCT03593044|183438469|OTHER|||||||0.5|||||||t-test, 2 sided|||Ghost images||||0.5
91585225|NCT04079803|183061464|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
91585226|NCT04079803|183061464|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
91708684|NCT02187861|183310306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.04|5.37|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.||5.37|0.04|
91778584|NCT03593044|183438469|OTHER|||||||0.9|||||||t-test, 2 sided|||Strain/tiredness||||0.9
91778585|NCT03593044|183438469|OTHER|||||||0.9|||||||t-test, 2 sided|||Changing vision||||0.9
91778586|NCT03593044|183438469|OTHER|||||||0.3|||||||t-test, 2 sided|||Headache frequency||||0.3
91778587|NCT03593044|183438469|OTHER|||||||0.7|||||||t-test, 2 sided|||Distance clarity||||0.7
91778588|NCT03593044|183438469|OTHER|||||||0.3|||||||t-test, 2 sided|||Computer clarity||||0.3
91778589|NCT03593044|183438469|OTHER|||||||0.1|||||||t-test, 2 sided|||Small print clarity||||0.1
91778590|NCT03593044|183438469|OTHER|||||||1|||||||t-test, 2 sided|||Vision during sports/hobbies||||1.0
91778591|NCT03593044|183438469|OTHER|||||||0.2|||||||t-test, 2 sided|||Overall vision||||0.2
91778592|NCT03593044|183438469|OTHER|||||||0.7|||||||t-test, 2 sided|||Light sensitivity||||0.7
91778593|NCT03593044|183438469|OTHER|||||||0.002|||||||t-test, 2 sided|||Discomfort during bright light||||0.002
91778594|NCT03593044|183438470|OTHER|||||||0.001|||||||t-test, 2 sided|||Right eye intraocular pressure||||0.001
91778595|NCT03593044|183438470|OTHER|||||||0.05|||||||t-test, 2 sided|||Left eye intraocular pressure||||0.05
91778596|NCT00554216|183438472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.36|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|8.43|10.3||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||10.30|8.43|<0.0001
91778597|NCT00554216|183438472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|2.38|4.71||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.71|2.38|<0.0001
91778598|NCT00554216|183438472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|4.65|6.99||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||6.99|4.65|<0.0001
91778599|NCT00554216|183438473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|STANDARD_ERROR_OF_MEAN|1.463|<|0.0001|TWO_SIDED|95.0|7.13|12.95||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||12.95|7.13|<0.0001
91778600|NCT00554216|183438473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|2.8|5.63||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||5.63|2.80|<0.0001
91778601|NCT00554216|183438473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|STANDARD_ERROR_OF_MEAN|0.394|<|0.0001|TWO_SIDED|95.0|1.76|3.33||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.33|1.76|<0.0001
91778602|NCT01347112|183438508|SUPERIORITY_OR_OTHER|||||||0.034||||||1 tailed fisher's exact test|Fisher Exact|1 tailed||||||0.034
91778603|NCT01347112|183438509|SUPERIORITY_OR_OTHER|||||||0.044||||||1 tailed fisher's exact|Fisher Exact|1 tailed||||||0.044
91778604|NCT01347112|183438510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-4.7|2.1|||||data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate|||2.1|-4.7|
91778605|NCT05462756|183438512|NON_INFERIORITY|The sample size provided \>99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.|LS Mean Difference|-0.012|||||TWO_SIDED|95.0|-0.14|0.116||||||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|
91778606|NCT05462756|183438513|SUPERIORITY||LS Mean Difference|-0.012||||0.855|TWO_SIDED|95.0|-0.14|0.116|||ANCOVA|||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|0.855
91778607|NCT05462756|183438514|SUPERIORITY||Odds Ratio (OR)|1.11||||0.504|TWO_SIDED|95.0|0.81|1.52|||Chi-squared|||||1.52|0.81|0.504
91778608|NCT05462756|183438515|SUPERIORITY||Relative rate|0.67||||0.058|TWO_SIDED|95.0|0.44|1.01|||Negative binomial model||Relative rate is the ratio of the group means (Insulin Efsitora vs Insulin Glargine).|Group mean is determined by Negative Binomial Model using Number of episodes = Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.||1.01|0.44|0.058
91778609|NCT05462756|183438516|SUPERIORITY||LS Mean Difference|-4.29||||0.104|TWO_SIDED|95.0|-9.461|0.886|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||0.886|-9.461|0.104
91778610|NCT05462756|183438517|SUPERIORITY||LS Mean Difference|1.35||||0.337|TWO_SIDED|95.0|-1.404|4.101|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||4.101|-1.404|0.337
91778611|NCT05462756|183438518|SUPERIORITY||LS Mean Difference|1.59||||0.104|TWO_SIDED|95.0|-0.327|3.508|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||3.508|-0.327|0.104
91778612|NCT05462756|183438519|SUPERIORITY||LS Mean Difference|-1.5||||0.304|TWO_SIDED|95.0|-4.358|1.36|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||1.360|-4.358|0.304
91708685|NCT02187861|183310306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.63|||||HR was calculated using Cox regression.|Unstratified Analysis||5.63|0.05|
91708686|NCT01301079|183310324|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Mann-Whitney|||||||0.113
91585227|NCT01668667|183061505|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.57|STANDARD_ERROR_OF_MEAN|0.745||0.014|TWO_SIDED|95.0|-4.62|-0.52|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.52|-4.62|0.014
91585228|NCT01668667|183061505|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.764||0.014|TWO_SIDED|95.0|-4.68|-0.54|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.54|-4.68|0.014
91585229|NCT01668667|183061505|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.767||0.144|TWO_SIDED|95.0|-3.63|0.53|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||0.53|-3.63|0.144
91708687|NCT01301079|183310325|SUPERIORITY_OR_OTHER|||||||0.946|TWO_SIDED||||||t-test, 2 sided|||||||0.946
91778613|NCT05462756|183438520|SUPERIORITY||LS Mean Difference|0.23||||0.523|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||LS Mean was determined by MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.||0.95|-0.48|0.523
91778614|NCT05462756|183438521|SUPERIORITY||LS Mean Difference|-35.04|||<|0.001|TWO_SIDED|95.0|-55.57|-14.5|||Mixed Models Analysis|||LS Mean was determined by Mixed Model Repeated Measures (MMRM) model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-14.50|-55.57|<0.001
91778615|NCT05462756|183438522|SUPERIORITY||LS Mean Difference|-7.55|||<|0.001|TWO_SIDED|95.0|-10.79|-4.3|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-4.30|-10.79|<0.001
91778616|NCT05462756|183438523|SUPERIORITY||LS Mean Difference|-73.5|||<|0.001|TWO_SIDED|95.0|-107.81|-39.2|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-39.20|-107.81|<0.001
91778617|NCT05462756|183438524|SUPERIORITY||LS Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|1.49|5.58|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||5.58|1.49|<0.001
91778618|NCT05462756|183438525|SUPERIORITY||Mean Difference (Net)|1.11||||0.442|TWO_SIDED|95.0|0.85|1.44|||Negative binomial model|||Group mean was reported and determined by Negative binomial method using Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.||1.44|0.85|0.442
91778619|NCT05462756|183438526|SUPERIORITY||LS Mean Difference|0.14||||0.543|TWO_SIDED|95.0|-0.32|0.6|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-0.32|0.543
91778620|NCT05462756|183438527|SUPERIORITY||LS Mean Difference|1.8||||0.099|TWO_SIDED|95.0|-0.3|4.0|||ANCOVA|||LS Mean was determined by ANCOVA model using Country + Personal Use CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables.||4.0|-0.3|0.099
91778621|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||MI at 0-6 Months||||>0.999
91778622|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-12 Months||||0.4889
91778623|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-18 Months||||0.4889
91778624|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-6 Months||||>0.999
91778625|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-12 Months||||>0.999
91778626|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-18 Months||||>0.999
91778627|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.7381|||||||Fisher Exact|||Major amputation at 0-6 Months||||0.7381
91778628|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-12 Months||||>0.999
91778629|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-18 Months||||>0.999
91778630|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Revascularization at 0-6 Months||||>0.999
91778631|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-12 Months||||0.4591
91778632|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-18 Months||||0.4591
91778633|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-6 Months||||>0.999
91778634|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-12 Months||||>0.999
91778635|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-18 Months||||>0.999
91778636|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.5136|||||||Fisher Exact|||0-6 Months (Major Amputation or Death)||||0.5136
91778637|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-12 Months (Major Amputation or Death)||||0.7575
91585230|NCT01668667|183061506|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.004|TWO_SIDED|95.0|1.3|3.95|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.95|1.30|0.004
91585231|NCT01668667|183061506|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.007|TWO_SIDED|95.0|1.23|3.77|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.77|1.23|0.007
91708688|NCT01301079|183310326|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||t-test, 2 sided|||||||0.999
91778638|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Death)||||>0.999
91778639|NCT02144610|183438531|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-6 Months (Major Amputation or Revascularization)||||0.7575
91778640|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-12 Months (Major Amputation or Revascularization)||||>0.999
91778641|NCT02144610|183438531|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Revascularization)||||>0.999
91778642|NCT02144610|183438532|SUPERIORITY_OR_OTHER|||||||0.514|||||||ANCOVA|||Change from Baseline at Month 3||||0.514
91778643|NCT02144610|183438532|SUPERIORITY_OR_OTHER|||||||0.445|||||||ANCOVA|||Change from Baseline at Month 6||||0.445
91778644|NCT02144610|183438532|SUPERIORITY_OR_OTHER|||||||0.863|||||||ANCOVA|||Change from Baseline at Month 9||||0.863
91778645|NCT02144610|183438532|SUPERIORITY_OR_OTHER|||||||0.111|||||||ANCOVA|||Change from Baseline at Month 12||||0.111
91778646|NCT02144610|183438532|SUPERIORITY_OR_OTHER|||||||0.153|||||||ANCOVA|||Change from Baseline at Month 15||||0.153
91778647|NCT02144610|183438532|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||Change from Baseline at last observation carried forward (LOCF)||||0.002
91778648|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.733|||||||ANCOVA|||Change from baseline at Month 3 (right brachial)||||0.733
91778649|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.808|||||||ANCOVA|||Change from baseline at Month 6 (right brachial)||||0.808
91778650|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.487|||||||ANCOVA|||Change from baseline at Month 9 (right brachial)||||0.487
91778651|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.216|||||||ANCOVA|||Change from baseline at Month 12 (right brachial)||||0.216
91778652|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|||Change from baseline at Month 15 (right brachial)||||0.896
91778653|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANCOVA|||Change from baseline at last observation carried forward (LOCF) (right brachial)||||0.167
91778654|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.378|||||||ANCOVA|||Change from baseline at Month 3 (left brachial)||||0.378
91778655|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANCOVA|||Change from baseline at Month 6 (left brachial)||||0.390
91778656|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.521|||||||ANCOVA|||Change from baseline at Month 9 (left brachial)||||0.521
91778657|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|||Change from baseline at Month 12 (left brachial)||||0.044
91778658|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.423|||||||ANCOVA|||Change from baseline at Month 15 (left brachial)||||0.423
91778659|NCT02144610|183438535|SUPERIORITY_OR_OTHER|||||||0.989|||||||ANCOVA|||Change from baseline at LOCF (left brachial)||||0.989
91778660|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.803|||||||ANCOVA|||Change from Baseline at Month 3 (Dorsalis Pedis)||||0.803
91708689|NCT01301079|183310327|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||0.019
91708690|NCT01301079|183310328|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||t-test, 2 sided|||||||0.652
91778661|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.668|||||||ANCOVA|||Change from Baseline at Month 6 (Dorsalis Pedis)||||0.668
91778662|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.789|||||||ANCOVA|||Change from Baseline at Month 9 (Dorsalis Pedis)||||0.789
91778663|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|||Change from Baseline at Month 12 (Dorsalis Pedis)||||0.280
91778664|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.324|||||||ANCOVA|||Change from Baseline at LOCF (Dorsalis Pedis)||||0.324
91778665|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||Change from Baseline at Month 3 (Posterior Tibial)||||0.759
91778666|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.414|||||||ANCOVA|||Change from Baseline at Month 6 (Posterior Tibial)||||0.414
91778667|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.886|||||||ANCOVA|||Change from Baseline at Month 9 (Posterior Tibial)||||0.886
91778668|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANCOVA|||Change from Baseline at Month 12 (Posterior Tibial)||||0.114
91778669|NCT02144610|183438536|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Change from Baseline at LOCF (Posterior Tibial)||||0.051
91778670|NCT02144610|183438537|SUPERIORITY_OR_OTHER|||||||0.211|||||||ANCOVA|||Change from Baseline at Month 3||||0.211
91778671|NCT02144610|183438537|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|||Change from Baseline at Month 6||||0.036
91778672|NCT02144610|183438537|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANCOVA|||Change from Baseline at Month 9||||0.725
91778673|NCT02144610|183438537|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||Change from Baseline at Month 12||||0.468
91778674|NCT02144610|183438537|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANCOVA|||Change from Baseline at Month 15||||0.854
91778675|NCT02144610|183438537|SUPERIORITY_OR_OTHER|||||||0.233|||||||ANCOVA|||Change from Baseline at LOCF||||0.233
91778676|NCT02144610|183438538|SUPERIORITY_OR_OTHER|||||||0.268|||||||ANCOVA|||Change from Baseline at Month 3||||0.268
91778677|NCT02144610|183438538|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANCOVA|||Change from Baseline at Month 6||||0.320
91778678|NCT02144610|183438538|SUPERIORITY_OR_OTHER|||||||0.315|||||||ANCOVA|||Change from Baseline at Month 9||||0.315
91778679|NCT02144610|183438538|SUPERIORITY_OR_OTHER|||||||0.327|||||||ANCOVA|||Change from Baseline at Month 12||||0.327
91778680|NCT02144610|183438538|SUPERIORITY_OR_OTHER|||||||0.643|||||||ANCOVA|||Change from Baseline at Month 15||||0.643
91778681|NCT02144610|183438538|SUPERIORITY_OR_OTHER|||||||0.74|||||||ANCOVA|||Change from Baseline at LOCF||||0.740
91585232|NCT01668667|183061506|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.27|3.94|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.94|1.27|0.005
91585233|NCT01668667|183061507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||ANOVA|||For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.||||0.022
91778682|NCT02144610|183438539|SUPERIORITY_OR_OTHER|||||||0.147|||||||ANCOVA|||Change from Baseline at Month 3||||0.147
91778683|NCT02144610|183438539|SUPERIORITY_OR_OTHER|||||||0.032|||||||ANCOVA|||Change from Baseline at Month 6||||0.032
91778684|NCT02144610|183438539|SUPERIORITY_OR_OTHER|||||||0.709|||||||ANCOVA|||Change from Baseline at Month 9||||0.709
91778685|NCT02144610|183438539|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANCOVA|||Change from Baseline at Month 12||||0.771
91778686|NCT02144610|183438539|SUPERIORITY_OR_OTHER|||||||0.83|||||||ANCOVA|||Change from Baseline at Month 15||||0.830
91778687|NCT02144610|183438539|SUPERIORITY_OR_OTHER|||||||0.033|||||||ANCOVA|||Change from Baseline at LOCF||||0.033
91778688|NCT02144610|183438540|SUPERIORITY_OR_OTHER|||||||0.105|||||||ANCOVA|||Pain (LOCF)||||0.105
91778689|NCT02144610|183438540|SUPERIORITY_OR_OTHER|||||||0.557|||||||ANCOVA|||Symptom (LOCF)||||0.557
91778690|NCT02144610|183438540|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||Activities (LOCF)||||0.940
91778691|NCT02144610|183438540|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|||Social (LOCF)||||0.905
91778692|NCT02144610|183438540|SUPERIORITY_OR_OTHER|||||||0.782|||||||ANCOVA|||Emotional Functioning (LOCF)||||0.782
91778693|NCT02144610|183438540|SUPERIORITY_OR_OTHER|||||||0.802|||||||ANCOVA|||Composite Overall (LOCF)||||0.802
91778694|NCT02144610|183438541|SUPERIORITY_OR_OTHER|||||||0.941|||||||ANCOVA|||Change from Baseline at Month 3||||0.941
91778695|NCT02144610|183438541|SUPERIORITY_OR_OTHER|||||||0.584|||||||ANCOVA|||Change from Baseline at Month 6||||0.584
91778696|NCT02144610|183438541|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|||Change from Baseline at Month 9||||0.100
91521188|NCT02954354|182917034|SUPERIORITY|||||||0.5317||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.5317
91778697|NCT02144610|183438541|SUPERIORITY_OR_OTHER|||||||0.916|||||||ANCOVA|||Change from Baseline at Month 12||||0.916
91778698|NCT02144610|183438541|SUPERIORITY_OR_OTHER|||||||0.486|||||||ANCOVA|||Change from Baseline at Month 15||||0.486
91778699|NCT02144610|183438541|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANCOVA|||Change from Baseline at LOCF||||0.835
91778700|NCT01432730|183438568|SUPERIORITY||Log mean difference (Active - Placebo)|-0.6027||||0.0003|TWO_SIDED|95.0|-0.9049|-0.3005|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.3005|-0.9049|0.0003
91778701|NCT01432730|183438569|SUPERIORITY||Mean Difference (Final Values)|-25.57||||0.003|TWO_SIDED|95.0|-41.53|-9.62|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-9.62|-41.53|0.003
91778702|NCT01432730|183438570|SUPERIORITY||Log mean difference (Active - Placebo)|-0.4212||||0.057|TWO_SIDED|95.0|-0.8568|0.01438|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||0.01438|-0.8568|0.057
91778703|NCT01432730|183438571|SUPERIORITY||Mean Difference (Final Values)|-8.53||||0.172|TWO_SIDED|95.0|-20.93|3.87|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||3.87|-20.93|0.172
91778704|NCT01432730|183438572|SUPERIORITY||Log mean difference (Active - Placebo)|-0.582||||0.001|TWO_SIDED|95.0|-0.8934|-0.2707|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.2707|-0.8934|0.001
91585234|NCT01668667|183061507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED||||||ANOVA|||Overall treatment effect||||0.072
91778705|NCT01432730|183438573|SUPERIORITY||Mean Difference (Final Values)|-2.538||||0.033|TWO_SIDED|95.0|-4.849|-0.227|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.227|-4.849|0.033
91778706|NCT01432730|183438574|SUPERIORITY||Median Difference (Final Values)|-2.267||||0.049|TWO_SIDED|95.0|-4.523|-0.01|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.010|-4.523|0.049
91778707|NCT01432730|183438575|SUPERIORITY||Mean Difference (Final Values)|-9.237||||0.018|TWO_SIDED|95.0|-16.759|-1.716|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.716|-16.759|0.018
91778708|NCT01432730|183438576|SUPERIORITY||Mean Difference (Final Values)|-21.25||||0.035|TWO_SIDED|95.0|-40.96|-1.54|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.54|-40.96|0.035
91778709|NCT03881852|183438584|SUPERIORITY||||||<|0.001||||||P-value calculated from LSMean|Mixed Models Analysis|||||||<0.001
91778710|NCT01421719|183438604|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||t-test, 2 sided|||Paired t test comparison of baseline number of urinary leaks per day versus number of leaks per day at 6 month evaluation after treatment.||||0.0087
91778711|NCT02653417|183438613|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|||||||||Regimen 1 = 5 mg vs Regimen 4 = placebo||||
91778712|NCT02653417|183438613|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Regimen 2 = 10 mg vs Regimen 4 = placebo||||
91778713|NCT02653417|183438613|SUPERIORITY||Mean Difference (Final Values)|0.46|||||TWO_SIDED|||||||||Regimen 3 = 20 mg vs Regimen 4 = placebo||||
91778714|NCT02494323|183438637|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value is adjusted for the comparison of subjects who benefited, were satisfied and willing to continue using the Segmented Electrodes versus subjects who didn't benefit, wern't satisfied ans were not willing to continue using the Segmented Eletrode|t-test, 1 sided|||||||<0.01
91585235|NCT01668667|183061508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.|Cochran-Armitage trend test|||||||0.012
91585236|NCT02988622|183061509|SUPERIORITY||Mean Difference (Net)|0.1205|STANDARD_DEVIATION|0.5499||0.0492|TWO_SIDED||||||t-test, 2 sided|||||||0.0492
91585237|NCT02988622|183061510|SUPERIORITY||Mean Difference (Net)|0.241|STANDARD_DEVIATION|0.0817||0.0817|TWO_SIDED||||||t-test, 2 sided|||||||0.0817
91778715|NCT03847896|183438638|SUPERIORITY||Mean Difference (Final Values)|60.5||||0.025|TWO_SIDED|95.0|7.7|113.4|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||113.4|7.7|0.025
91778716|NCT03847896|183438638|SUPERIORITY||Mean Difference (Final Values)|161.9|||<|0.001|TWO_SIDED|95.0|109.4|214.5|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||214.5|109.4|<0.001
91778717|NCT03847896|183438638|SUPERIORITY||Mean Difference (Final Values)|80.7||||0.003|TWO_SIDED|95.0|28.4|132.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||132.9|28.4|0.003
91778718|NCT03847896|183438639|SUPERIORITY||Mean Difference (Final Values)|73.3||||0.037|TWO_SIDED|95.0|4.4|142.2|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||142.2|4.4|0.037
91778719|NCT03847896|183438639|SUPERIORITY||Mean Difference (Final Values)|99.9||||0.005|TWO_SIDED|95.0|30.9|168.8|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||168.8|30.9|0.005
91778720|NCT03847896|183438639|SUPERIORITY||Mean Difference (Final Values)|132.8|||<|0.001|TWO_SIDED|95.0|63.6|201.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||201.9|63.6|<0.001
91778721|NCT03847896|183438639|SUPERIORITY||Mean Difference (Final Values)|87.9||||0.013|TWO_SIDED|95.0|18.8|156.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||156.9|18.8|0.013
91778722|NCT03847896|183438639|SUPERIORITY||Mean Difference (Final Values)|120.8|||<|0.001|TWO_SIDED|95.0|51.5|190.1|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||190.1|51.5|<0.001
91778723|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-6.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-6|
91778724|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-3.0|9.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||9|-3|
91778725|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
91778726|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
91778727|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-3|
91778728|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-2|
91778729|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
91778730|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
91585238|NCT02988622|183061511|SUPERIORITY||Mean Difference (Net)|0.3659|STANDARD_DEVIATION|1.7951||0.0686|TWO_SIDED||||||t-test, 2 sided|||||||0.0686
91585239|NCT02988622|183061512|SUPERIORITY||Mean Difference (Net)|-0.0843|STANDARD_DEVIATION|1.5789||0.6278|TWO_SIDED||||||t-test, 2 sided|||||||0.6278
91585240|NCT02988622|183061513|SUPERIORITY||Mean Difference (Net)|0.3373|STANDARD_DEVIATION|1.7619||0.0848|TWO_SIDED||||||t-test, 2 sided|||||||0.0848
91585241|NCT02988622|183061514|SUPERIORITY||Mean Difference (Net)|0.2195|STANDARD_DEVIATION|2.0788||0.3418|TWO_SIDED||||||t-test, 2 sided|||||||0.3418
91585242|NCT02988622|183061515|SUPERIORITY||Mean Difference (Net)|0.2375|STANDARD_DEVIATION|1.5528||0.1752|TWO_SIDED||||||t-test, 2 sided|||||||0.1752
91708691|NCT01301079|183310329|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||t-test, 2 sided|||||||0.221
91585243|NCT02988622|183061517|SUPERIORITY||Mean Difference (Net)|0.3824|STANDARD_DEVIATION|1.5685||0.0281|TWO_SIDED||||||t-test, 2 sided|||||||0.0281
91778731|NCT03847896|183438640|SUPERIORITY||Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-1|
91778732|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|0.699||||0.118|TWO_SIDED|95.0|0.445|1.096|||Regression, Logistic|||Comparison is not type-I error controlled.||1.096|0.445|0.118
91778733|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|1.386||||0.161|TWO_SIDED|95.0|0.878|2.187|||Regression, Logistic|||Comparison is not type-I error controlled.||2.187|0.878|0.161
91778734|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|1.605||||0.044|TWO_SIDED|95.0|1.013|2.541|||Regression, Logistic|||Comparison is not type-I error controlled.||2.541|1.013|0.044
91778735|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|1.626||||0.039|TWO_SIDED|95.0|1.024|2.584|||Regression, Logistic|||Comparison is not type-I error controlled.||2.584|1.024|0.039
91778736|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|2.297|||<|0.001|TWO_SIDED|95.0|1.456|3.626|||Regression, Logistic|||Comparison is not type-I error controlled.||3.626|1.456|<0.001
91778737|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|2.328|||<|0.001|TWO_SIDED|95.0|1.471|3.687|||Regression, Logistic|||Comparison is not type-I error controlled.||3.687|1.471|<0.001
91778738|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|1.158||||0.532|TWO_SIDED|95.0|0.731|1.835|||Regression, Logistic|||Comparison is not type-I error controlled.||1.835|0.731|0.532
91778739|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|1.174||||0.499|TWO_SIDED|95.0|0.737|1.868|||Regression, Logistic|||Comparison is not type-I error controlled.||1.868|0.737|0.499
91778740|NCT03847896|183438642|SUPERIORITY||Odds Ratio (OR)|1.014||||0.955|TWO_SIDED|95.0|0.635|1.618|||Regression, Logistic|||Comparison is not type-I error controlled.||1.618|0.635|0.955
91778741|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|-42.1||||0.169|TWO_SIDED|95.0|-101.9|17.8|||ANCOVA|||Comparison is not type-I error controlled.||17.8|-101.9|0.169
91778742|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|52.1||||0.086|TWO_SIDED|95.0|-7.4|111.5|||ANCOVA|||Comparison is not type-I error controlled.||111.5|-7.4|0.086
91585244|NCT03261700|183061525|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on Empowerment via the Personal Progress Scale Revised||||<.05
91585245|NCT03261700|183061526|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on self-efficacy via the General Self-Efficacy Scale||||<.05
91778743|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|30.7||||0.31|TWO_SIDED|95.0|-28.6|90.1|||ANCOVA|||Comparison is not type-I error controlled.||90.1|-28.6|0.31
91778744|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|65.9||||0.03|TWO_SIDED|95.0|6.3|125.4|||ANCOVA|||Comparison is not type-I error controlled.||125.4|6.3|0.03
91778745|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|72.8||||0.017|TWO_SIDED|95.0|13.1|132.5|||ANCOVA|||Comparison is not type-I error controlled.||132.5|13.1|0.017
91778746|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|107.9|||<|0.001|TWO_SIDED|95.0|48.1|167.8|||ANCOVA|||Comparison is not type-I error controlled.||167.8|48.1|<0.001
91778747|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.48|TWO_SIDED|95.0|-80.5|37.9|||ANCOVA|||Comparison is not type-I error controlled.||37.9|-80.5|0.48
91585246|NCT00413972|183061568|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
91585247|NCT00413972|183061568|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
91585248|NCT00413972|183061568|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
91778748|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|13.8||||0.648|TWO_SIDED|95.0|-45.6|73.2|||ANCOVA|||Comparison is not type-I error controlled.||73.2|-45.6|0.648
91778749|NCT03847896|183438643|SUPERIORITY||Mean Difference (Final Values)|35.1||||0.246|TWO_SIDED|95.0|-24.2|94.5|||ANCOVA|||Comparison is not type-I error controlled.||94.5|-24.2|0.246
91778750|NCT03038880|183438676|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.1|||||TWO_SIDED|80.0|-6.8|2.6|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|||2.6|-6.8|
91585249|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.78||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.78|1.10|
91585250|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.32||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.32|0.90|
91585251|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.13||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.13|1.19|
91778751|NCT03038880|183438676|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.1|||||TWO_SIDED|80.0|-3.4|5.5|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|||5.5|-3.4|
91778752|NCT03038880|183438677|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.09|||||TWO_SIDED|80.0|-6.75|2.56|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||2.56|-6.75|
91778753|NCT03038880|183438677|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.05|||||TWO_SIDED|80.0|-3.4|5.49|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||5.49|-3.40|
91585252|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.62|0.93|
91585253|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|12.1|||||TWO_SIDED|95.0|8.63|17.08||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||17.08|8.63|
91585254|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.82|3.48||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.48|1.82|
91585255|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.98|3.87||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.87|1.98|
91585256|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.0|4.08||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||4.08|2.00|
91647260|NCT02216214|183186277|SUPERIORITY||Rate Ratio|0.8||||0.014|TWO_SIDED|95.0|0.67|0.96||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.96|0.67|0.014
91708692|NCT01301079|183310330|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
91708693|NCT01301079|183310331|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||t-test, 2 sided|||||||0.386
91708694|NCT01301079|183310332|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||t-test, 1 sided|||||||0.499
91708695|NCT01301079|183310333|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||t-test, 2 sided|||||||0.909
91708696|NCT01301079|183310334|SUPERIORITY_OR_OTHER|||||||0.737|TWO_SIDED||||||t-test, 2 sided|||||||0.737
91708697|NCT01301079|183310335|SUPERIORITY_OR_OTHER||||||<|0.872|TWO_SIDED||||||t-test, 2 sided|||||||<0.872
91708698|NCT01301079|183310336|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED||||||t-test, 2 sided|||||||0.598
91708699|NCT01301079|183310337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.485|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.485
91708700|NCT01301079|183310338|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||t-test, 2 sided|||||||0.744
91708701|NCT01301079|183310339|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.540
91708702|NCT01301079|183310340|SUPERIORITY_OR_OTHER|||||||0.673|TWO_SIDED||||||t-test, 2 sided|||||||0.673
91708703|NCT01301079|183310341|SUPERIORITY_OR_OTHER|||||||0.586|TWO_SIDED||||||t-test, 2 sided|||||||0.586
91708704|NCT01301079|183310342|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||t-test, 2 sided|||||||0.077
91708705|NCT01301079|183310343|SUPERIORITY_OR_OTHER|||||||0.677|TWO_SIDED||||||t-test, 2 sided|||||||0.677
91708706|NCT01301079|183310344|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED||||||t-test, 2 sided|||||||0.545
91708707|NCT01301079|183310345|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|||||||0.650
91708708|NCT01301079|183310346|SUPERIORITY_OR_OTHER|||||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||0.593
91708709|NCT01301079|183310347|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
91708710|NCT01301079|183310348|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
91708711|NCT01301079|183310349|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
91708712|NCT01301079|183310350|SUPERIORITY_OR_OTHER|||||||0.611|TWO_SIDED||||||Chi-squared|||||||0.611
91708713|NCT01301079|183310351|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||t-test, 2 sided|||||||0.312
91708714|NCT01301079|183310352|SUPERIORITY_OR_OTHER|||||||0.676|TWO_SIDED||||||t-test, 2 sided|||||||0.676
91708715|NCT01301079|183310353|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||t-test, 2 sided|||||||0.938
91708716|NCT01301079|183310354|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||t-test, 2 sided|||||||0.385
91708717|NCT01301079|183310355|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|||||||0.422
91708718|NCT01301079|183310356|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.500
91708719|NCT01301079|183310357|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||t-test, 2 sided|||||||0.435
91708720|NCT01301079|183310358|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||||||0.745
91708721|NCT01301079|183310359|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||t-test, 2 sided|||||||0.557
91708722|NCT00264290|183310362|OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
91708723|NCT04472494|183310367|SUPERIORITY||Odds Ratio (OR)|1.07||||0.9297|TWO_SIDED|95.0|0.26|4.49|||Cochran-Mantel-Haenszel Chi-Square test|||||4.49|0.26|0.9297
91708724|NCT04472494|183310368|SUPERIORITY||Adjusted mean difference from Placebo|0.64||||0.74|TWO_SIDED|95.0|-0.55|1.82|||Cochran-Mantel-Haenszel|||||1.82|-0.55|0.7400
91708725|NCT04472494|183310369|SUPERIORITY||Estimate of Difference|-0.1||||0.9684|TWO_SIDED|95.0|-20.55|20.34|||Cochran-Mantel-Haenszel Chi-Square test||Estimate of Difference is based on minimum risk weights|||20.34|-20.55|0.9684
91708726|NCT04472494|183310370|SUPERIORITY||Odds Ratio (OR)|0.85||||0.8504|TWO_SIDED|95.0|0.18|3.97|||Cochran-Mantel-Haenszel|||||3.97|0.18|0.8504
91708727|NCT04472494|183310371|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2724|TWO_SIDED|95.0|0.53|9.82|||Cochran-Mantel-Haenszel|||||9.82|0.53|0.2724
91708728|NCT04472494|183310371|SUPERIORITY||Estimate of difference|12.78|||||TWO_SIDED|95.0|-10.61|36.17|||||||Estimate of difference is based on minimum risk weights|36.17|-10.61|
91708729|NCT04472494|183310372|SUPERIORITY||Odds Ratio (OR)|2.03||||0.4734|TWO_SIDED|95.0|0.33|12.64|||Cochran-Mantel-Haenszel|||||12.64|0.33|0.4734
91585257|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.64|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.21|0.64|
91585258|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.39|2.51||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.51|1.39|
91585259|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.41||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.41|1.56|
91708730|NCT04472494|183310372|SUPERIORITY||Estimate of difference|5.43|||||TWO_SIDED|95.0|-16.71|27.57|||||Estimate of difference is based on minimum risk weights|||27.57|-16.71|
91521189|NCT02954354|182917034|SUPERIORITY|||||||0.2144||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2144
91585260|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.72|1.28||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.28|0.72|
91585261|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.2|||||TWO_SIDED|95.0|3.67|7.33||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||7.33|3.67|
91585262|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.08|1.73||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.73|1.08|
91708731|NCT02144077|183310428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -15%|Difference in Percentage|1.6|||<|0.0001|ONE_SIDED|97.5|-6.5||||Farrington and Manning Test|Difference of proportions|||||-6.5|<0.0001
91708732|NCT00368459|183310454|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||For this pilot trial, we did not anticipate power to detect significant, clinically-meaningful between-group differences of the magnitude provided by FDA-approved AD therapies over a 12 month treatment period, but we specified that we would report trends (alpha \<0.1) as a guide to future effectiveness studies.||||>0.1
91708733|NCT00368459|183310455|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708734|NCT00368459|183310456|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708735|NCT00368459|183310457|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708736|NCT00368459|183310458|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708737|NCT00368459|183310459|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708738|NCT00368459|183310460|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708739|NCT00368459|183310461|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Favoring placebo, unadjusted for multiple comparisons|ANCOVA|||||||<0.01
91708740|NCT00368459|183310462|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708741|NCT00368459|183310463|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
91708742|NCT02620683|183310464|OTHER||Median Difference (Final Values)|-15.0||||0.006|TWO_SIDED|95.0|-34.6|-5.86|||Wilcoxon (Mann-Whitney)||for a cross over design difference in blood level was calculate buffered lidocaine minus non-buffered lidocaine|The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||-5.86|-34.6|0.006
91708743|NCT02620683|183310465|OTHER||Mean Difference (Final Values)|-0.66||||0.096|TWO_SIDED|95.0|-1.46|0.13|||t-test, 2 sided|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using ProcTTEST (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||0.13|-1.46|0.096
91708744|NCT02620683|183310466|OTHER||Median Difference (Final Values)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||1|-4|0.23
91708745|NCT02087943|183310482|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.01||||0.1308|TWO_SIDED|95.0|-34.52|4.5||Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||4.50|-34.52|0.1308
91708746|NCT02087943|183310482|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6||||0.0347|TWO_SIDED|95.0|-39.7|-1.5||Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||-1.50|-39.70|0.0347
91708747|NCT02087943|183310483|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-2.7||||0.4938|TWO_SIDED|95.0|-10.2|4.8||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, Cochran-Mantel-Haenszel (CMH) weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||4.8|-10.2|0.4938
91708748|NCT02087943|183310483|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|8.0||||0.1368|TWO_SIDED|95.0|-2.3|18.2||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, CMH weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||18.2|-2.3|0.1368
91708749|NCT02087943|183310484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-1.5||||0.8589|TWO_SIDED|95.0|-18.0|14.9|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||14.9|-18.0|0.8589
91708750|NCT02087943|183310484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|9.9||||0.2476|TWO_SIDED|95.0|-6.7|26.6|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||26.6|-6.7|0.2476
91585263|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.19|0.81|
91585264|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.07|1.77||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.77|1.07|
91585265|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4||||||95.0|1.01|1.8||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.80|1.01|
91585266|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.15||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.15|1.30|
91708751|NCT02087943|183310485|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.17||||0.5286|TWO_SIDED|95.0|-21.34|10.99|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||10.99|-21.34|0.5286
91708752|NCT02087943|183310485|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.17||||0.6092|TWO_SIDED|95.0|-20.22|11.88|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||11.88|-20.22|0.6092
91708753|NCT01690299|183310488|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|27.5|||<|0.0001|TWO_SIDED|95.0|14.9|40.1||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||40.1|14.9|< 0.0001
91708754|NCT01690299|183310489|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|35.9|||<|0.0001|TWO_SIDED|95.0|23.3|48.5||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||48.5|23.3|<0.0001
91708755|NCT01690299|183310490|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.0||||0.0005|TWO_SIDED|95.0|8.4|27.7||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The p-value is from a CMH test stratified by the BMI at screening.|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.|||27.7|8.4|0.0005
91708756|NCT01690299|183310490|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|14.8|35.5||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.||||35.5|14.8|<0.0001
91708757|NCT01690299|183310491|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.33|-19.46|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-19.46|-43.33|<0.0001
91708758|NCT01690299|183310491|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-39.85|||<|0.0001|TWO_SIDED|95.0|-51.78|-27.92|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-27.92|-51.78|<0.0001
91708759|NCT01690299|183310492|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|29.4||||0.0002|TWO_SIDED|95.0|14.9|43.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||43.9|14.9|0.0002
91708760|NCT01690299|183310492|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|49.8|||<|0.0001|TWO_SIDED|95.0|36.9|62.7||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||62.7|36.9|<0.0001
91708761|NCT01690299|183310493|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.48|||<|0.0001|TWO_SIDED|95.0|-6.82|-2.14|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-2.14|-6.82|<0.0001
91708762|NCT01690299|183310493|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-3.94||||0.0004|TWO_SIDED|95.0|-6.27|-1.6|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-1.60|-6.27|0.0004
91708763|NCT01690299|183310494|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.93||||0.7112|TWO_SIDED|95.0|-2.05|3.9|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||3.90|-2.05|0.7112
91708764|NCT01690299|183310494|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|2.22||||0.1719|TWO_SIDED|95.0|-0.75|5.19|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||5.19|-0.75|0.1719
91708765|NCT01690299|183310495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.1||||0.0011|TWO_SIDED|95.0|7.6|28.6||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||28.6|7.6|0.0011
91708766|NCT01690299|183310495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0021|TWO_SIDED|95.0|6.5|26.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||26.9|6.5|0.0021
91778754|NCT03038880|183438677|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.49|||||TWO_SIDED|80.0|-4.26|5.25|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||5.25|-4.26|
91585267|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.24|2.12||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.24|
91778755|NCT03038880|183438677|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.83|||||TWO_SIDED|80.0|-2.71|6.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||6.37|-2.71|
91778756|NCT03038880|183438679|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-15.92|25.44|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||25.44|-15.92|
91778757|NCT03038880|183438679|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|5.95|||||TWO_SIDED|80.0|-13.62|25.53|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||25.53|-13.62|
91778758|NCT03038880|183438679|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.17|||||TWO_SIDED|80.0|-24.52|16.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||16.19|-24.52|
91778759|NCT03038880|183438679|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|8.93|||||TWO_SIDED|80.0|-10.73|28.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.59|-10.73|
91778760|NCT03038880|183438681|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.76|||||TWO_SIDED|80.0|-10.72|1.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||1.19|-10.72|
91778761|NCT03038880|183438681|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
91778762|NCT03038880|183438681|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||||
91778763|NCT03038880|183438681|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
91778764|NCT03038880|183438682|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|21.9|||||TWO_SIDED|80.0|0.76|43.05|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||43.05|0.76|
91778765|NCT03038880|183438682|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|38.57|||||TWO_SIDED|80.0|19.56|57.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||57.59|19.56|
91778766|NCT03038880|183438682|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|19.64|||||TWO_SIDED|80.0|-1.14|40.43|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||40.43|-1.14|
91778767|NCT03038880|183438682|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|33.93|||||TWO_SIDED|80.0|14.95|52.91|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||52.91|14.95|
91778768|NCT03038880|183438683|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||||
91778769|NCT03038880|183438683|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
91708767|NCT01882803|183310529|OTHER||||||<=|0.0001||||||'\<=' represents '≤'|Exact Binomial Test|The p-value was calculated by 1-sided exact binomial test with the null hypothesis that ORR ≤30%.||ORR was tested against the null (≤30%) by 1-sided exact binomial test at 0.025 level.||||<=0.0001
91778770|NCT03038880|183438683|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-1.19|10.72|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||10.72|-1.19|
91778771|NCT03038880|183438683|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
91778772|NCT03038880|183438684|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.45|||||TWO_SIDED|80.0|-29.81|30.71|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||30.71|-29.81|
91778773|NCT03038880|183438684|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|14.68|||||TWO_SIDED|80.0|-14.29|43.65|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||43.65|-14.29|
91778774|NCT03038880|183438684|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-4.85|||||TWO_SIDED|80.0|-30.57|20.87|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||20.87|-30.57|
91778775|NCT03038880|183438684|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.12|||||TWO_SIDED|80.0|-23.57|25.8|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||25.80|-23.57|
91585268|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.03|1.79||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.79|1.03|
91585269|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5||||||95.0|1.11|1.98||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.98|1.11|
91585270|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.16|2.12||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.16|
91585271|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.86|1.47||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.47|0.86|
91585272|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.69|1.16|
91647261|NCT02216214|183186277|SUPERIORITY||Rate Ratio|0.81||||0.043|TWO_SIDED|95.0|0.66|0.99||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.99|0.66|0.043
91778776|NCT03038880|183438685|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-12.23|||||TWO_SIDED|80.0|-36.6|12.15|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||12.15|-36.60|
91778777|NCT03038880|183438685|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|4.98|||||TWO_SIDED|80.0|-18.5|28.45|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||28.45|-18.50|
91778778|NCT03038880|183438685|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-8.64|||||TWO_SIDED|80.0|-30.42|13.14|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||13.14|-30.42|
91778779|NCT03038880|183438685|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|7.36|||||TWO_SIDED|80.0|-13.65|28.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.37|-13.65|
91778780|NCT03926611|183438703|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-13.66|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-17.51|-9.81|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.81|-17.51|<0.0001
91778781|NCT03926611|183438703|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-13.64|STANDARD_ERROR_OF_MEAN|2.336|<|0.0001|TWO_SIDED|90.0|-17.49|-9.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.78|-17.49|<0.0001
91778782|NCT03926611|183438703|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-9.21|STANDARD_ERROR_OF_MEAN|2.277|<|0.0001|TWO_SIDED|90.0|-12.97|-5.45|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.45|-12.97|<0.0001
91778783|NCT03926611|183438703|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-10.55|STANDARD_ERROR_OF_MEAN|2.319|<|0.0001|TWO_SIDED|90.0|-14.38|-6.72|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-6.72|-14.38|<0.0001
91778784|NCT03926611|183438703|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-14.58|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-18.43|-10.73|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-10.73|-18.43|<0.0001
91778785|NCT03926611|183438703|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-12.62|STANDARD_ERROR_OF_MEAN|2.327|<|0.0001|TWO_SIDED|90.0|-16.45|-8.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-8.78|-16.45|<0.0001
91778786|NCT03926611|183438704|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-10.24|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|90.0|-14.72|-5.77|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.77|-14.72|<0.0001
91778787|NCT03926611|183438704|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-10.11|STANDARD_ERROR_OF_MEAN|2.711||0.0001|TWO_SIDED|90.0|-14.58|-5.63|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.63|-14.58|0.0001
91778788|NCT03926611|183438704|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-7.4|STANDARD_ERROR_OF_MEAN|2.635||0.0027|TWO_SIDED|90.0|-11.75|-3.05|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-3.05|-11.75|0.0027
91778789|NCT03926611|183438704|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-9.8|STANDARD_ERROR_OF_MEAN|2.696||0.0002|TWO_SIDED|90.0|-14.25|-5.35|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.35|-14.25|0.0002
91778790|NCT03926611|183438704|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-12.35|STANDARD_ERROR_OF_MEAN|2.714|<|0.0001|TWO_SIDED|90.0|-16.82|-7.87|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-7.87|-16.82|<0.0001
91778791|NCT03926611|183438704|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-9.52|STANDARD_ERROR_OF_MEAN|2.733||0.0003|TWO_SIDED|90.0|-14.03|-5.01|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.01|-14.03|0.0003
91790185|NCT02660138|183459523|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|12.63|||<|0.0001|TWO_SIDED|95.0|5.4|29.56||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 800 U versus Placebo.||29.56|5.40|<0.0001
91585273|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.54||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.54|0.87|
91585274|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.94|1.84||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.84|0.94|
91585275|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.4|||||TWO_SIDED|95.0|2.03|2.87||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.87|2.03|
91585276|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||1.13|0.84|
91585277|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.92|2.76||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.76|1.92|
91585278|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.55|2.42||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.42|1.55|
91585279|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.84|2.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.67|1.84|
91585280|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.13|5.93||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.13|
91585281|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.41|3.49||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.49|2.41|
91585282|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.34|3.52||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.52|2.34|
91585283|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.01|5.93||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.01|
91585284|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.91|2.79||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.79|1.91|
91585285|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|2.02|2.66||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.66|2.02|
91647262|NCT02216214|183186277|SUPERIORITY||Rate Ratio|0.69||||0.002|TWO_SIDED|95.0|0.54|0.87||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.87|0.54|0.002
91585286|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.0|||||TWO_SIDED|95.0|2.44|3.6||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.60|2.44|
91585287|NCT00427895|183061577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|3.31|5.31||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.31|3.31|
91585288|NCT00427895|183061578|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|39.2|||||TWO_SIDED|95.0|33.0|45.1||||||||45.1|33.0|
91585289|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.4|||||TWO_SIDED|95.0|2.32|5.09||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||5.09|2.32|
91585290|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.13|2.16||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.13|
91585291|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.88|1.98||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.98|0.88|
91647263|NCT02216214|183186279|SUPERIORITY||Odds Ratio (OR)|1.5||||0.005||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.005
91647264|NCT02216214|183186280|SUPERIORITY||Odds Ratio (OR)|1.775|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||<0.001
91585292|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.2|||||TWO_SIDED|95.0|2.04|4.97||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.97|2.04|
91585293|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.5|4.0||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.00|1.50|
91647265|NCT02216214|183186281|SUPERIORITY||Odds Ratio (OR)|1.501||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
91521190|NCT02954354|182917034|SUPERIORITY|||||||0.0413||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.0413
91647266|NCT02216214|183186282|SUPERIORITY||Odds Ratio (OR)|1.39||||0.034||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.034
91647267|NCT02216214|183186282|SUPERIORITY||Odds Ratio (OR)|1.327||||0.07||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.070
91521191|NCT02954354|182917034|SUPERIORITY|||||||0.0409||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.0409
91647268|NCT02216214|183186282|SUPERIORITY||Odds Ratio (OR)|1.452||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
91585294|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.7|||||TWO_SIDED|95.0|2.76|7.99||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||7.99|2.76|
91585295|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.93|2.97||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.97|0.93|
91585296|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|0.99|2.39||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.39|0.99|
91585297|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.37|3.5||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.50|1.37|
91585298|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.78|3.68||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.68|1.78|
91585299|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.77|4.01||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.01|1.77|
91585300|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.5|||||TWO_SIDED|95.0|1.99|6.13||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||6.13|1.99|
91585301|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|2.87|6.08||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.08|2.87|
91585302|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.26|4.3||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.30|2.26|
91585303|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT ratio|2.6|||||TWO_SIDED|95.0|1.72|3.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.80|1.72|
91585304|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|6.5|||||TWO_SIDED|95.0|4.09|10.19||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.19|4.09|
91585305|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|1.83|4.63||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.63|1.83|
91585306|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.8|||||TWO_SIDED|95.0|2.41|6.03||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.03|2.41|
91585307|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.8|||||TWO_SIDED|95.0|3.13|10.82||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.82|3.13|
91647269|NCT02216214|183186282|SUPERIORITY||Odds Ratio (OR)|1.116||||0.602||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.602
91585308|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.3|2.84||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.84|1.30|
91585309|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.02|4.78||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.78|2.02|
91647270|NCT02216214|183186283|SUPERIORITY||Odds Ratio (OR)|1.634||||0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.001
91521192|NCT02954354|182917035|SUPERIORITY||Difference|-19.8|||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
91647271|NCT02216214|183186284|SUPERIORITY||Odds Ratio (OR)|1.597||||0.003||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.003
91647272|NCT02216214|183186286|SUPERIORITY|||||||0.471||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.471
91778792|NCT00836693|183438712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|2.2|5.5||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||5.5|2.2|<0.001
91778793|NCT00836693|183438713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|5.1|18.3||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.3|5.1|<0.001
91778794|NCT00836693|183438714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.0|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|8.9|27.0||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||27.0|8.9|<0.001
91778795|NCT00836693|183438718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|9.5|22.8||P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||22.8|9.5|<0.001
91778796|NCT00836693|183438719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.11|>|0.001|TWO_SIDED|95.0|13.9|26.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANOVA|||The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||26.1|13.9|>0.001
91778797|NCT00836693|183438720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|5.5|18.0||p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.0|5.5|<0.001
91778798|NCT00836693|183438720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|6.6|19.8||p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||19.8|6.6|<0.001
91778799|NCT00836693|183438720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|3.34||0.0034|TWO_SIDED|95.0|3.3|16.5||p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||16.5|3.3|0.0034
91585310|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.87|3.76||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.76|1.87|
91585311|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.4|||||TWO_SIDED|95.0|2.97|6.58||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.58|2.97|
91585312|NCT00427895|183061579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.5|||||TWO_SIDED|95.0|3.2|9.41||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||9.41|3.20|
91521193|NCT02954354|182917036|SUPERIORITY||Difference|-0.7||||0.4194||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4194
91778800|NCT00836693|183438720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|3.52||0.002|TWO_SIDED|95.0|4.1|17.9||p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||17.9|4.1|0.0020
91778801|NCT00836693|183438720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|4.07||0.0653|TWO_SIDED|95.0|-0.5|15.6||p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||15.6|-0.5|0.0653
91778802|NCT00836693|183438721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
91778803|NCT00836693|183438722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0089|TWO_SIDED|95.0|0.2|1.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.1|0.2|0.0089
91778804|NCT00836693|183438723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.37||0.0461|TWO_SIDED|95.0|0.0|1.5||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.5|0.0|0.0461
91778805|NCT00836693|183438724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
91778806|NCT00836693|183438725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|2.22||0.0047|TWO_SIDED|95.0|2.0|10.7||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||10.7|2.0|0.0047
91778807|NCT00836693|183438726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|4.99|<|0.001|TWO_SIDED|95.0|14.6|34.3||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||34.3|14.6|<0.001
91585313|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|1.9|11.2||||||Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.2|1.9|
91585314|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.9|||||TWO_SIDED|95.0|-0.3|8.1||||||Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.1|-0.3|
91708768|NCT03066778|183310542|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.00069|TWO_SIDED|95.0|0.6|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.88|0.60|0.00069
91585315|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.4|||||TWO_SIDED|95.0|-0.2|7.2||||||Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-0.2|
91585316|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.3|||||TWO_SIDED|95.0|-2.6|7.2||||||Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-2.6|
91647273|NCT05354206|183186292|SUPERIORITY||Mean Difference (Final Values)|0.405|STANDARD_DEVIATION|0.285|<|0.05|TWO_SIDED|||||p-values have not been adjusted for multiple comparisons|t-test, 2 sided||Difference of RST from 1 for hip range of motion task without stimulation.|"Reticulospinal tract (RST) contribution computed as RST = (visual - startle)/(visual - auditory) reaction times, where a RST value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task.~A one sample t-test (or Wilcoxon signed-rank test for non-normally distributed data) was used to test the hypothesis that the RST contribution for a given movement was significantly greater than 1."||||<0.05
91778808|NCT00836693|183438727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5|STANDARD_ERROR_OF_MEAN|4.96|<|0.001|TWO_SIDED|95.0|13.7|33.2||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||33.2|13.7|<0.001
91585317|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|26.6|||||TWO_SIDED|95.0|21.7|31.7||||||Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||31.7|21.7|
91585318|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.5|||||TWO_SIDED|95.0|3.2|12.0||||||Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|3.2|
91778809|NCT00836693|183438728|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
91778810|NCT00836693|183438729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
91778811|NCT01122238|183438745|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.665
91778812|NCT01122238|183438745|SUPERIORITY_OR_OTHER|||||||0.562|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.562
91778813|NCT01122238|183438745|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.536
91778814|NCT01122238|183438745|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.206
91778815|NCT01122238|183438746|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.98|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.98
91778816|NCT01122238|183438746|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.4|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.40
91778817|NCT01122238|183438746|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.99|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.99
91778818|NCT01122238|183438746|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.33|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.33
91778819|NCT00129402|183438747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
91585319|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|12.3|||||TWO_SIDED|95.0|7.3|17.4||||||Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||17.4|7.3|
91708769|NCT03066778|183310543|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01643|TWO_SIDED|95.0|0.64|0.98|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.98|0.64|0.01643
91585320|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|14.1|||||TWO_SIDED|95.0|8.7|19.5||||||Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||19.5|8.7|
91778820|NCT00129402|183438748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
91585321|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.6|3.8||||||Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.8|-5.6|
91778821|NCT00129402|183438749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
91778822|NCT00129402|183438750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||non-parametric model|||||||.48
91778823|NCT00129402|183438751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
91778824|NCT00129402|183438752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0|||||ANOVA|||||||.95
91778825|NCT02900378|183438772|OTHER||Differences of least square means|5.68|STANDARD_ERROR_OF_MEAN|4.89||0.2464|TWO_SIDED|95.0|-3.93|15.29||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS)||15.29|-3.93|0.2464
91778826|NCT02900378|183438772|OTHER||Differences of least square means|8.98|STANDARD_ERROR_OF_MEAN|4.58||0.0503|TWO_SIDED|97.5|-1.31|19.27||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without AE/SAE)||19.27|-1.31|0.0503
91778827|NCT02900378|183438773|OTHER||Differences of least square means|-6.14|STANDARD_ERROR_OF_MEAN|8.61||0.4769|TWO_SIDED|97.5|-25.7|13.41||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with MI)||13.41|-25.70|0.4769
91778828|NCT02900378|183438773|OTHER||Differences of least square means|-5.67|STANDARD_ERROR_OF_MEAN|6.01||0.3463|TWO_SIDED|95.0|-17.48|6.14||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with LOCF)||6.14|-17.48|0.3463
91778829|NCT02900378|183438773|OTHER||Differences of least square means|-6.24|STANDARD_ERROR_OF_MEAN|6.69||0.3513|TWO_SIDED|95.0|-19.39|6.91||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without MI/LOCF)||6.91|-19.39|0.3513
91778830|NCT02900378|183438774|OTHER||Odds Ratio (OR)|1.228|||||TWO_SIDED|95.0|0.882|1.708||||||FAS population||1.708|0.882|
91585322|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|2.6|10.5||||||Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.5|2.6|
91778831|NCT02900378|183438775|OTHER||Odds Ratio (OR)|1.251|||||TWO_SIDED|95.0|0.895|1.748||||||FAS subset without AE/SAE||1.748|0.895|
91778832|NCT02900378|183438776|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.634|2.464||||||FAS population||2.464|0.634|
91778833|NCT02900378|183438777|OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.644|2.544||||||FAS subset without AE/SAE||2.544|0.644|
91778834|NCT02900378|183438778|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.863|1.811||||||FAS population||1.811|0.863|
91585323|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.2|7.1||||||Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.1|1.2|
91778835|NCT02900378|183438779|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.865|1.834||||||FAS subset without AE/SAE||1.834|0.865|
91778836|NCT02900378|183438780|OTHER|||||||0.1814|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS)||||0.1814
91778837|NCT02900378|183438780|OTHER|||||||0.3315|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS without AE/SAE)||||0.3315
91778838|NCT02900378|183438780|OTHER|||||||0.2414|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS)||||0.2414
91778839|NCT02900378|183438780|OTHER|||||||0.1793|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS without AE/SAE)||||0.1793
91778840|NCT02900378|183438781|OTHER||Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.462|1.457||||||Increased levels (\>= 10% increase) of non sedentary daytime physical activity at Week 12||1.457|0.462|
91778841|NCT02900378|183438782|OTHER|||||||0.0516|||||||Chi-squared|||Week 4||||0.0516
91778842|NCT02900378|183438782|OTHER|||||||0.9025|||||||Chi-squared|||Week 8||||0.9025
91778843|NCT02900378|183438782|OTHER|||||||0.6713|||||||Chi-squared|||Week 12||||0.6713
91778844|NCT02900378|183438783|OTHER|||||||0.0029|||||||Chi-squared|||Week 4||||0.0029
91778845|NCT02900378|183438783|OTHER|||||||0.7754|||||||Chi-squared|||Week 8||||0.7754
91778846|NCT02900378|183438783|OTHER|||||||0.2172|||||||Chi-squared|||Week 12||||0.2172
91778847|NCT02900378|183438784|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0008
91778848|NCT02900378|183438784|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0008
91778849|NCT02900378|183438784|OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0297
91778850|NCT02900378|183438784|OTHER|||||||0.0069|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0069
91778851|NCT02900378|183438784|OTHER|||||||0.2275|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.2275
91778852|NCT02900378|183438784|OTHER|||||||0.3486|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.3486
91778853|NCT02900378|183438784|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.6800
91778854|NCT02900378|183438784|OTHER|||||||0.7184|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.7184
91585324|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|-1.2|||||TWO_SIDED|95.0|-5.5|3.2||||||Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.||3.2|-5.5|
91585325|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|23.2|||||TWO_SIDED|95.0|17.0|29.3||||||Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||29.3|17.0|
91585326|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.6|||||TWO_SIDED|95.0|-0.2|7.5||||||Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.5|-0.2|
91585327|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-3.6|4.1||||||Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.1|-3.6|
91585328|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.4|||||TWO_SIDED|95.0|-0.4|5.5||||||Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.5|-0.4|
91778855|NCT02900378|183438784|OTHER|||||||0.5301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5301
91778856|NCT02900378|183438784|OTHER|||||||0.6019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.6019
91778857|NCT02900378|183438784|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8229
91778858|NCT02900378|183438784|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.8229
91778859|NCT02900378|183438785|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0001
91778860|NCT02900378|183438785|OTHER|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0123
91778861|NCT02900378|183438785|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.2560
91778862|NCT02900378|183438785|OTHER|||||||0.5865|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.5865
91778863|NCT02900378|183438785|OTHER|||||||0.5463|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.5463
91778864|NCT02900378|183438785|OTHER|||||||0.3212|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.3212
91585329|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.8|3.9||||||Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.9|-5.8|
91778865|NCT02900378|183438786|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0004
91778866|NCT02900378|183438786|OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0009
91778867|NCT02900378|183438786|OTHER|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0094
91778868|NCT02900378|183438786|OTHER|||||||0.0301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0301
91778869|NCT02900378|183438786|OTHER|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.1557
91778870|NCT02900378|183438786|OTHER|||||||0.6461|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6461
91778871|NCT02900378|183438786|OTHER|||||||0.9759|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.9759
91778872|NCT02900378|183438786|OTHER|||||||0.3941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3941
91778873|NCT02900378|183438786|OTHER|||||||0.7209|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.7209
91778874|NCT02900378|183438786|OTHER|||||||0.4444|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4444
91778875|NCT02900378|183438786|OTHER|||||||0.7247|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.7247
91778876|NCT02900378|183438786|OTHER|||||||0.2933|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.2933
91778877|NCT02900378|183438787|OTHER|||||||0.0854|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0854
91778878|NCT02900378|183438787|OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0528
91778879|NCT02900378|183438787|OTHER|||||||0.4137|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.4137
91778880|NCT02900378|183438787|OTHER|||||||0.0082|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0082
91778881|NCT02900378|183438787|OTHER|||||||0.7908|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.7908
91778882|NCT02900378|183438787|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6499
91778883|NCT02900378|183438787|OTHER|||||||0.5547|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.5547
91778884|NCT02900378|183438787|OTHER|||||||0.6961|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.6961
91778885|NCT02900378|183438787|OTHER|||||||0.5946|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5946
91778886|NCT02900378|183438787|OTHER|||||||0.8957|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.8957
91778887|NCT02900378|183438787|OTHER|||||||0.8468|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8468
91778888|NCT02900378|183438787|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1711
91778889|NCT02900378|183438788|OTHER|||||||0.0065|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0065
91778890|NCT02900378|183438788|OTHER|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0316
91778891|NCT02900378|183438788|OTHER|||||||0.1342|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.1342
91778892|NCT02900378|183438788|OTHER|||||||0.0252|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0252
91778893|NCT02900378|183438788|OTHER|||||||0.9024|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.9024
91778894|NCT02900378|183438788|OTHER|||||||0.9052|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.9052
91778895|NCT02900378|183438788|OTHER|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2870
91778896|NCT02900378|183438788|OTHER|||||||0.3174|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3174
91778897|NCT02900378|183438788|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5020
91585330|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.2|||||TWO_SIDED|95.0|-0.4|4.8||||||Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.8|-0.4|
91778898|NCT02900378|183438788|OTHER|||||||0.4037|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4037
91778899|NCT02900378|183438788|OTHER|||||||0.4823|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4823
91778900|NCT02900378|183438788|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1090
91778901|NCT02900378|183438789|OTHER|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0061
91778902|NCT02900378|183438789|OTHER|||||||0.0143|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0143
91778903|NCT02900378|183438789|OTHER|||||||0.0708|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0708
91778904|NCT02900378|183438789|OTHER|||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0750
91778905|NCT02900378|183438789|OTHER|||||||0.8017|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.8017
91778906|NCT02900378|183438789|OTHER|||||||0.7956|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.7956
91778907|NCT02900378|183438789|OTHER|||||||0.3499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.3499
91778908|NCT02900378|183438789|OTHER|||||||0.1192|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.1192
91778909|NCT02900378|183438789|OTHER|||||||0.5237|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5237
91778910|NCT02900378|183438789|OTHER|||||||0.3902|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.3902
91778911|NCT02900378|183438789|OTHER|||||||0.4228|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4228
91778912|NCT02900378|183438789|OTHER|||||||0.1571|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1571
91778913|NCT02900378|183438790|OTHER|||||||0.3231|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.3231
91778914|NCT02900378|183438790|OTHER|||||||0.3519|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.3519
91778915|NCT02900378|183438790|OTHER|||||||0.8335|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.8335
91778916|NCT02900378|183438790|OTHER|||||||0.0465|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0465
91778917|NCT02900378|183438790|OTHER|||||||0.5016|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.5016
91778918|NCT02900378|183438790|OTHER|||||||0.5941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.5941
91778919|NCT02900378|183438790|OTHER|||||||0.2019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2019
91778920|NCT02900378|183438790|OTHER|||||||0.4125|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.4125
91778921|NCT02900378|183438790|OTHER|||||||0.5702|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5702
91778922|NCT02900378|183438790|OTHER|||||||0.4752|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4752
91778923|NCT02900378|183438790|OTHER|||||||0.5343|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.5343
91778924|NCT02900378|183438790|OTHER|||||||0.0985|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.0985
91778925|NCT02900378|183438791|OTHER|||||||0.4525|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.4525
91778926|NCT02900378|183438791|OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0445
91778927|NCT02900378|183438791|OTHER|||||||0.1158|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.1158
91778928|NCT02900378|183438791|OTHER|||||||0.3901|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3901
91778929|NCT02900378|183438791|OTHER|||||||0.7725|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.7725
91778930|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.1974||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.1974
91778931|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
91778932|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
91778933|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
91778934|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.7418||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.7418
91778935|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.2429||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.2429
91778936|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
91778937|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
91778938|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
91778939|NCT01134055|183438793|SUPERIORITY_OR_OTHER|||||||0.7673||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.7673
91778940|NCT00001959|183438819|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||H0: GFR Decrease during baseline period and treatment period are same||||<0.01
91778941|NCT00001959|183438820|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Kruskal-Wallis|||H0: Proteinuria during baseline and treatment periods are same||||0.16
91778942|NCT03592186|183438831|SUPERIORITY|In zero-inflated distributions, two outcomes can be specified: 1) probability of being an excess zero (falling outside expected negative binomial distribution), and 2) count value, if not an excess zero. Our focal effect of interest was Time\*Condition in the count distribution, i.e. effect of condition over time on predicting the percent of days used greater than zero.|Risk Ratio (RR)|1.15|STANDARD_ERROR_OF_MEAN|2.57||0.12|TWO_SIDED|95.0|0.97|1.36|||Mixed Models Analysis|||Mixed models with zero-inflated distributions evaluated whether there was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used. We tested the primary outcome (percent of days of use over the past 90 days, adjusted for time in a controlled environment) for overall number of days of use.||1.36|.97|.12
91585331|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.0|||||TWO_SIDED|95.0|0.8|7.2||||||Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|0.8|
91585332|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.4|||||TWO_SIDED|95.0|0.6|8.2||||||Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.2|0.6|
91585333|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.8|||||TWO_SIDED|95.0|-0.3|7.9||||||Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.9|-0.3|
91585334|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Perecentage|4.2|||||TWO_SIDED|95.0|-0.1|8.7||||||Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.7|-0.1|
91585335|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-3.8|2.5||||||Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||2.5|-3.8|
91585336|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-2.1|1.9||||||Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||1.9|-2.1|
91521194|NCT02954354|182917037|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-23.1|||<|0.0001|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
91585337|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.9|||||TWO_SIDED|95.0|-2.4|6.2||||||Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.2|-2.4|
91585338|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.5|||||TWO_SIDED|95.0|-4.7|5.7||||||Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|-4.7|
91585339|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.2|||||TWO_SIDED|95.0|4.3|10.6||||||Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.6|4.3|
91585340|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.6|||||TWO_SIDED|95.0|-0.3|5.9||||||Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.9|-0.3|
91585341|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.2|||||TWO_SIDED|95.0|2.1|6.9||||||Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.9|2.1|
91778943|NCT03592186|183438832|SUPERIORITY||Risk Ratio (RR)|-0.1|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||Mixed models using a linear distribution evaluated whether change in substance-related problems differed by condition. The focal effect was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used.||.07|-.34|.19
91778944|NCT03592186|183438833|SUPERIORITY||Chi-square value|0.01||||0.92|TWO_SIDED||||||Chi-squared|||Comparison of the count of positive urine screens by condition at 12 weeks||||.92
91778945|NCT03755934|183438834|SUPERIORITY||LS mean estimate|-1.96|STANDARD_ERROR_OF_MEAN|0.961||0.0437|TWO_SIDED|95.0|-3.87|-0.06||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.06|-3.87|0.0437
91778946|NCT03755934|183438834|SUPERIORITY||LS mean estimate|0.72|STANDARD_ERROR_OF_MEAN|0.541||0.1878|TWO_SIDED|95.0|-0.36|1.79||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||1.79|-0.36|0.1878
91778947|NCT03755934|183438834|SUPERIORITY||LS mean estimate|-1.39|STANDARD_ERROR_OF_MEAN|0.407||0.0009|TWO_SIDED|95.0|-2.19|-0.58||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.58|-2.19|0.0009
91778948|NCT04266717|183438863|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91778949|NCT05523089|183438900|SUPERIORITY||Hodges-Lehmann estimator|-1.2||||0.039|TWO_SIDED|95.0|-5.7|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-5.7|0.0390
91778950|NCT05523089|183438902|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0185|TWO_SIDED|95.0|-2.9|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.0|-2.9|0.0185
91778951|NCT05523089|183438904|SUPERIORITY|||||||0.0613||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.0613
91778952|NCT05523089|183438905|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.1587|TWO_SIDED|95.0|-2.4|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-2.4|0.1587
91778953|NCT05523089|183438907|SUPERIORITY||Mean Difference (Net)|-1.1||||0.0236|TWO_SIDED|95.0|-2.0|-0.1||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.1|-2.0|0.0236
91778954|NCT05523089|183438909|SUPERIORITY|||||||0.1282||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.1282
91778955|NCT05523089|183438910|SUPERIORITY||Mean Difference (Net)|-5.4||||0.2877|TWO_SIDED|95.0|-11.2|0.3||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.3|-11.2|0.2877
91778956|NCT05523089|183438912|SUPERIORITY||Mean Difference (Net)|-1.8||||0.2517|TWO_SIDED|95.0|-4.1|0.6||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.6|-4.1|0.2517
91585342|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|5.1|||||TWO_SIDED|95.0|1.4|9.1||||||Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.1|1.4|
91585343|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.7|||||TWO_SIDED|95.0|1.7|6.1||||||Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.1|1.7|
91708770|NCT03066778|183310544|SUPERIORITY||Percent Difference|8.9||||0.0227|TWO_SIDED|95.0|0.2|17.4|||Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.|Based on Miettinen \& Nurminen method stratified by platinum chemotherapy, ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||17.4|0.2|0.02270
91778957|NCT05523089|183438916|SUPERIORITY|||||||0.9024||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.9024
91778958|NCT05523089|183438917|SUPERIORITY|||||||0.0248||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.0248
91778959|NCT05523089|183438919|SUPERIORITY|||||||0.1224||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1224
91778960|NCT05523089|183438921|SUPERIORITY|||||||0.1023||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1023
91778961|NCT05523089|183438923|SUPERIORITY|||||||0.1477||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1477
91778962|NCT05523089|183438925|SUPERIORITY|||||||0.1645||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1645
91778963|NCT02230995|183438966|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.22|STANDARD_DEVIATION|5.0|<|1e-05|TWO_SIDED|90.0|96.11|100.39|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.39|96.11|<0.00001
91778964|NCT02230995|183438967|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|102.14|STANDARD_DEVIATION|7.9|<|1e-05|TWO_SIDED|90.0|98.65|105.76|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||105.76|98.65|<0.00001
91778965|NCT02230995|183438968|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.7|STANDARD_DEVIATION|12.3|<|1e-05|TWO_SIDED|90.0|93.51|104.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||104.17|93.51|<0.00001
91585344|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.4|||||TWO_SIDED|95.0|4.1|9.3||||||Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.3|4.1|
91585345|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.2|||||TWO_SIDED|95.0|5.4|11.6||||||Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.6|5.4|
91585346|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.8|||||TWO_SIDED|95.0|4.8|11.4||||||Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.4|4.8|
91585347|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|11.2|||||TWO_SIDED|95.0|8.0|14.9||||||Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.9|8.0|
91585348|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.1|||||TWO_SIDED|95.0|0.9|5.7||||||Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|0.9|
91585349|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.4|||||TWO_SIDED|95.0|0.3|3.1||||||Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.1|0.3|
91708771|NCT03066778|183310549|OTHER||Difference in Least Square Means|4.43||||0.04|TWO_SIDED|95.0|0.21|8.66|||Log Rank|||||8.66|0.21|0.040
91778966|NCT02230995|183438969|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|105.69|STANDARD_DEVIATION|10.9|<|1e-05|TWO_SIDED|90.0|100.78|110.84|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||110.84|100.78|<0.00001
91778967|NCT02230995|183438970|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|98.32|STANDARD_DEVIATION|5.1|||TWO_SIDED|90.0|96.16|100.53|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.53|96.16|
91778968|NCT02230995|183438971|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|104.66|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|101.36|108.07|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||108.07|101.36|
91778969|NCT04040933|183438972|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.86|TWO_SIDED||||||ANCOVA|||||||0.860
91778970|NCT04040933|183438972|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.051|||||||ANCOVA|||||||0.051
91778971|NCT04040933|183438973|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.259|TWO_SIDED||||||ANCOVA|||||||0.259
91778972|NCT04040933|183438973|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.451|||||||ANCOVA|||||||0.451
91778973|NCT04040933|183438974|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||>|0.999|TWO_SIDED||||||ANCOVA|||||||>0.999
91778974|NCT04040933|183438974|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.739|||||||ANCOVA|||||||0.739
91778975|NCT04040933|183438975|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91585350|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.4|||||TWO_SIDED|95.0|5.4|12.0||||||Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|5.4|
91585351|NCT00427895|183061580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|10.5|||||TWO_SIDED|95.0|6.8|14.7||||||Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.7|6.8|
91585352|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.31|||||TWO_SIDED|95.0|1.52|3.51||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.51|1.52|
91585353|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.37|||||TWO_SIDED|95.0|0.95|1.99||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.99|0.95|
91585354|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.32|||||TWO_SIDED|95.0|1.47|3.64||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.64|1.47|
91521195|NCT02954354|182917038|SUPERIORITY||Difference|1.3||||0.4856||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4856
91585355|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.12||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.12|0.92|
91585356|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.01|2.16||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.01|
91585357|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.67|1.59||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.67|
91585358|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.34|||||TWO_SIDED|95.0|0.94|1.92||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.92|0.94|
91778976|NCT04040933|183438975|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.053|||||||ANCOVA|||||||0.053
91778977|NCT04040933|183438976|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.666|TWO_SIDED||||||ANCOVA|||||||0.666
91778978|NCT04040933|183438976|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.473|||||||ANCOVA|||||||0.473
91778979|NCT04040933|183438977|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.761|TWO_SIDED||||||ANCOVA|||||||0.761
91778980|NCT04040933|183438977|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.456|||||||ANCOVA|||||||0.456
91778981|NCT04040933|183438978|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.019|TWO_SIDED||||||ANCOVA|||||||0.019
91778982|NCT04040933|183438978|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.325|||||||ANCOVA|||||||0.325
91778983|NCT04040933|183438979|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001|TWO_SIDED|||||no adjustments|Boot-strap sampling method|||All hypothesis tests was conducted at 0.05 level without adjustment of multiple comparisons||||<0.001
91778984|NCT04040933|183438979|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001||||||no adjustments|Boot-strap sampling method|||||||<0.001
91778985|NCT02066181|183438982|SUPERIORITY||Hazard Ratio (HR)|11.3|||<|0.001|ONE_SIDED|95.0|5.7||||Log Rank||||||5.7|<0.001
91778986|NCT05764785|183439006|SUPERIORITY|||||||0.182||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.182
91778987|NCT05764785|183439007|SUPERIORITY|||||||0.461||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.461
91778988|NCT05764785|183439008|SUPERIORITY|||||||0.228||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.228
91778989|NCT05764785|183439009|SUPERIORITY|||||||0.295||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.295
91778990|NCT05764785|183439010|SUPERIORITY|||||||0.915||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.915
91778991|NCT05764785|183439011|SUPERIORITY|||||||0.226||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.226
91778992|NCT02141295|183439021|OTHER||Hazard Ratio (HR)|0.91|||=|0.6753|TWO_SIDED|95.0|0.6|1.39||log-rank|Regression, Cox|||Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.39|0.60|= 0.6753
91585359|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.33|||||TWO_SIDED|95.0|0.8|2.23||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.23|0.80|
91585360|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.68|1.59||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.68|
91585361|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.15|||||TWO_SIDED|95.0|0.8|1.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.66|0.80|
91585362|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.79||||||95.0|1.07|3.0||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.00|1.07|
91585363|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.45|||||TWO_SIDED|95.0|0.95|2.24||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.24|0.95|
91585364|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.18|||||TWO_SIDED|95.0|1.53|3.12||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.12|1.53|
91585365|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.06|1.91||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.91|1.06|
91585366|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.47|||||TWO_SIDED|95.0|1.71|3.55||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.55|1.71|
91585367|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.45|2.74||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.74|1.45|
91585368|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.04|||||TWO_SIDED|95.0|1.5|2.76||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.76|1.50|
91585369|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.85|||||TWO_SIDED|95.0|1.32|2.58||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.58|1.32|
91585370|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.46|2.62||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.62|1.46|
91585371|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.32|2.91||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.91|1.32|
91778993|NCT02141295|183439024|OTHER||Hazard Ratio (HR)|0.85|||=|0.574|TWO_SIDED|95.0|0.49|1.49|||Log Rank|||Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.49|0.49|= 0.5740
91778994|NCT00071890|183439046|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Chi-squared|||||||0.025
91778995|NCT00071890|183439047|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups|Wilcoxon (Mann-Whitney)|||||||0.069
91778996|NCT02904954|183439068|SUPERIORITY||Risk Difference (RD)|46.6||||0.0001|TWO_SIDED|95.0|26.7|66.6||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the MPR proportion between the two treatment arms. Null hypothesis is that there is no difference in the MPR proportion between the two arms.||66.6|26.7|0.0001
91778997|NCT02904954|183439069|SUPERIORITY|||||||0.89|||||||Log Rank|||Kaplan-Meier survival analysis comparing the two arms.||||0.89
91778998|NCT02904954|183439070|SUPERIORITY||Risk Difference (RD)|43.4||||0.0001|TWO_SIDED|95.0|24.4|62.3||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the objective clinical response proportion between the two treatment arms. Null hypothesis is that there is no difference in the objective clinical response proportion between the two arms. Objective clinical response proportion is defined as the proportion of patients in each arm who have complete response or partial response.||62.3|24.4|0.0001
91778999|NCT00753506|183439086|SUPERIORITY_OR_OTHER||F|1.59|||>|0.1|TWO_SIDED|95.0|||||ANOVA|||Repeated measures analaysis of variance||||>0.10
91779000|NCT03819114|183439088|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.2|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.20|0.81|
91779001|NCT03819114|183439088|EQUIVALENCE|Confidence Interval on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.6|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.60|1.12|
91779002|NCT03819114|183439088|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.27|2.18|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.18|1.27|
91779003|NCT03819114|183439088|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.45|0.78|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.45|
91779004|NCT03819114|183439089|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Fisher Exact|||||||1.00
91779005|NCT03819114|183439090|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.96|1.41|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.41|0.96|
91585372|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.36|||||TWO_SIDED|95.0|0.94|1.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.97|0.94|
91585373|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.08|2.03||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.03|1.08|
91585374|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|3.35|||||TWO_SIDED|95.0|2.19|5.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||5.12|2.19|
91585375|NCT00427895|183061582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.0|||||TWO_SIDED|95.0|1.41|2.83||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.83|1.41|
91585376|NCT03534284|183061607|SUPERIORITY|||||||0.6761||||||0.05 threshold for significance; no adjustment for multiple comparisons|Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 7||||0.6761
91585377|NCT03534284|183061608|SUPERIORITY|||||||0.8375|||||||Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 25||||0.8375
91585378|NCT03316300|183061631|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.0176|<|0.0001|TWO_SIDED|95.0|-0.13|-0.06|||Mixed Models Analysis|||||-0.06|-0.13|<0.0001
91585379|NCT02618642|183061637|SUPERIORITY|||||||0.3879|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared||||0.3879
91585380|NCT02618642|183061637|SUPERIORITY|||||||0.5361|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter were compared||||0.5361
91585381|NCT02618642|183061638|SUPERIORITY|||||||0.4669|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.||||0.4669
91585382|NCT02618642|183061638|SUPERIORITY|||||||0.4161|||||||Kruskal-Wallis|||||||0.4161
91585383|NCT02618642|183061639|SUPERIORITY|||||||0.9596|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.9596
91585384|NCT02618642|183061639|SUPERIORITY|||||||0.0907|||||||Kruskal-Wallis|||||||0.0907
91708772|NCT03066778|183310552|OTHER||Hazard Ratio (HR)|0.8||||0.208|TWO_SIDED|95.0|0.56|1.14|||Log Rank|Two-sided p-value based on stratified log-rank test|Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||1.14|0.56|0.208
91585385|NCT02618642|183061640|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.0110
91585386|NCT02618642|183061640|SUPERIORITY|||||||0.1165|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter (groups v, x, y,||||0.1165
91585387|NCT02618642|183061641|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||he results in the irradiated group (n=45) and the control group (n=15) were compared||||0.0200
91585388|NCT02618642|183061641|SUPERIORITY|comparison was conducted of the results obtained with a different filter (groups v, x, y,||||||0.0014|||||||Kruskal-Wallis|||||||0.0014
91585389|NCT00822523|183061664|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1||||0.61
91585390|NCT00822523|183061664|SUPERIORITY_OR_OTHER|||||||0.787|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2||||0.787
91585391|NCT00822523|183061664|SUPERIORITY_OR_OTHER|||||||0.234|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4||||0.234
91585392|NCT00822523|183061664|SUPERIORITY_OR_OTHER|||||||0.256|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14||||0.256
91585393|NCT00822523|183061664|SUPERIORITY_OR_OTHER|||||||0.292|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21||||0.292
91585394|NCT00822523|183061664|SUPERIORITY_OR_OTHER|||||||0.589|||||||t-test, 2 sided|||Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4||||0.589
91585395|NCT00822523|183061665|SUPERIORITY_OR_OTHER|||||||0.636|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurements||||0.636
91585396|NCT00822523|183061665|SUPERIORITY_OR_OTHER|||||||0.178|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment arm||||0.178
91708773|NCT00551525|183310554|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level 0.05, two-sided test|binomial proportion|||||||<0.001
91585397|NCT00822523|183061666|SUPERIORITY_OR_OTHER|||||||0.995|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21||||0.995
91585398|NCT00822523|183061666|SUPERIORITY_OR_OTHER|||||||0.2088|||||||Repeated measure ANOVA|||"Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment arm"||||0.2088
91585399|NCT00822523|183061668|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
91585400|NCT00822523|183061668|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
91585401|NCT00822523|183061668|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
91585402|NCT00822523|183061670|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
91585403|NCT00822523|183061670|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
91585404|NCT00822523|183061670|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
91585405|NCT00822523|183061671|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
91585406|NCT00822523|183061671|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
91585407|NCT00822523|183061671|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
91585408|NCT00822523|183061672|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
91585409|NCT00822523|183061672|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
91585410|NCT00822523|183061672|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
91585411|NCT00822523|183061673|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
91585412|NCT00822523|183061673|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
91585413|NCT00822523|183061673|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
91585414|NCT00822523|183061674|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
91585415|NCT00822523|183061674|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
91585416|NCT00822523|183061674|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
91585417|NCT00822523|183061675|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
91585418|NCT00822523|183061675|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
91585419|NCT00822523|183061675|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
91585420|NCT00822523|183061676|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
91585421|NCT00822523|183061676|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
91585422|NCT00822523|183061676|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
91585423|NCT00822523|183061677|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
91585424|NCT00822523|183061677|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
91585425|NCT00822523|183061677|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
91585426|NCT00822523|183061678|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
91585427|NCT00822523|183061678|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
91647274|NCT00713830|183186295|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.867|-0.621||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 570 patients in lixisenatide arm and 285 in placebo arm would provide a power of 99% (or 98%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.621|-0.867|<0.0001
91585428|NCT00822523|183061678|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
91585429|NCT00822523|183061679|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
91585430|NCT00822523|183061679|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
91585431|NCT00822523|183061679|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
91585432|NCT00822523|183061680|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
91585433|NCT00822523|183061680|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
91585434|NCT00822523|183061680|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
91647275|NCT02209272|183186311|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
91647276|NCT02209272|183186312|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
91585435|NCT03567434|183061681|SUPERIORITY|The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.283||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Frequency (Burst/Min)||||0.283
91585436|NCT03567434|183061681|SUPERIORITY|The original hypothesis was that resting MSNA burst incidence would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.92||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Incidence (Burst/100hb)||||0.920
91585437|NCT03567434|183061683|SUPERIORITY|The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.888||||||The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||||||0.888
91585438|NCT02181387|183061695|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
91585439|NCT02181387|183061695|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
91647277|NCT02209272|183186313|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
91521196|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7173|TWO_SIDED|95.0|-0.5|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.7|-0.5|0.7173
91585440|NCT02881957|183061696|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\<0.05 as significant. Adverse events were monitored until discharge.||||0.2
91585441|NCT02881957|183061697|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.4
91585442|NCT02881957|183061698|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
91585443|NCT02881957|183061699|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
91585444|NCT02881957|183061700|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.7
91585445|NCT02881957|183061701|SUPERIORITY|||||||0.99|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.99
91585446|NCT02881957|183061702|SUPERIORITY|||||||0.6|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.6
91585447|NCT02881957|183061703|SUPERIORITY|||||||0.7|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.7
91585448|NCT02881957|183061704|SUPERIORITY|||||||0.4|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.4
91585449|NCT02881957|183061705|SUPERIORITY|||||||0.1|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.1
91647278|NCT01676311|183186321|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group, CVLT-II-total learning score at baseline and week 12, and covariates (Beck Depression Index \[BDI\], time post-injury, British Columbia Postconcussion Symptom Inventory \[BC-PSI\]). Regression analyses were repeated, permuting data observations for each outcome. The BDI and BC-PSI are covariates in the regression model and not pre-specified Primary and Secondary Outcome Measures.||||0.38
91585450|NCT05269355|183061706|OTHER||Hazard Ratio (HR)|0.61||||0.0017|TWO_SIDED|95.0|0.45|0.83|||Regression, Cox|||||0.83|0.45|0.0017
91585451|NCT01880528|183061728|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
91585452|NCT01880528|183061729|SUPERIORITY|||||||0.0337|||||||Kruskal-Wallis|||||||0.0337
91585453|NCT01880528|183061730|SUPERIORITY|||||||0.0427|||||||Kruskal-Wallis|||||||0.0427
91585454|NCT01880528|183061731|SUPERIORITY|||||||0.0237|||||||Kruskal-Wallis|||||||0.0237
91585455|NCT01439360|183061732|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|63.2|||||TWO_SIDED|97.5|51.8|72.3|||Regression, Cox|Adjusted for age category and stratified for cohort.|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\>) 25%.||72.3|51.8|
91585456|NCT01439360|183061733|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|49.8|||||TWO_SIDED|97.5|41.8|56.8|||Regression, Cox|Adjusted for age category and stratified for cohort|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.||56.8|41.8|
91585457|NCT02072434|183061821|OTHER||Odds Ratio (OR)|0.46|||||TWO_SIDED|95.0|0.12|1.43||||||||1.43|0.12|
91585458|NCT02072434|183061822|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.64|3.55||||||||3.55|0.64|
91585459|NCT02072434|183061823|OTHER||Difference between percentages|-0.72|||||TWO_SIDED|95.0|-1.59|0.15||||||||0.15|-1.59|
91585460|NCT01117454|183061829|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank with continuity correction||||||0.008
91585461|NCT00676065|183061949|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||0.9|0.2|
91708774|NCT00551525|183310557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984|||||TWO_SIDED|95.0|0.91|1.063||||||Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and Gleason score (\<8 vs. 8-10\[reference level\]).||1.063|0.910|
91585462|NCT00676065|183061949|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||0.9|0.2|
91585463|NCT00676065|183061950|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.8|1.7|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.7|0.8|
91585464|NCT00676065|183061950|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.0|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.0|0.5|
91585465|NCT00676065|183061951|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.4|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.4|0.5|
91585466|NCT00676065|183061951|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.5|0.6|
91779006|NCT03819114|183439090|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.43|||||TWO_SIDED|90.0|1.21|1.69|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.69|1.21|
91779007|NCT03819114|183439090|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.17|1.96|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.96|1.17|
91779008|NCT03819114|183439090|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.6|1.0|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.00|0.60|
91779009|NCT03819114|183439091|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.37|||||TWO_SIDED|90.0|0.22|0.61|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.61|0.22|
91779010|NCT03819114|183439091|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.25|||||TWO_SIDED|90.0|0.15|0.44|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.44|0.15|
91779011|NCT03819114|183439091|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.11|||||TWO_SIDED|90.0|1.2|3.7|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.70|1.20|
91779012|NCT03819114|183439091|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.17|||||TWO_SIDED|90.0|0.09|0.32|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.32|0.09|
91779013|NCT03819114|183439092|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|4.03|||||TWO_SIDED|90.0|3.17|5.12|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||5.12|3.17|
91779014|NCT03819114|183439092|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.92|||||TWO_SIDED|90.0|2.33|3.65|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.65|2.33|
91779015|NCT03819114|183439092|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.82|1.52|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.52|0.82|
91779016|NCT03819114|183439092|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|3.62|||||TWO_SIDED|90.0|2.65|4.93|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||4.93|2.65|
91779017|NCT03819114|183439093|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.1|||||TWO_SIDED|90.0|1.66|2.65|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.65|1.66|
91779018|NCT03819114|183439093|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.39|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.39|0.89|
91779019|NCT03819114|183439093|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.2|||||TWO_SIDED|90.0|0.87|1.66|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.66|0.87|
91779020|NCT03819114|183439093|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.24|2.45|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.24|
91585467|NCT03952806|183061952|SUPERIORITY||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.4656|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||||1.30|-0.60|0.4656
91585468|NCT02875977|183061991|SUPERIORITY||Odds Ratio (OR)|1.794||||0.17|TWO_SIDED|95.0|0.782|4.119|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling||4.119|0.782|0.17
91585469|NCT02875977|183061992|SUPERIORITY||Odds Ratio (OR)|0.564||||0.056|TWO_SIDED|95.0|0.314|1.014|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling||1.014|0.314|0.056
91708775|NCT00551525|183310557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.89|1.169||||||Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), Gleason score (\<8 vs. 8-10\[reference level\]), and age.||1.169|0.890|
91779021|NCT03819114|183439094|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.52|||||TWO_SIDED|90.0|0.46|0.59|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.59|0.46|
91779022|NCT03819114|183439094|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.43|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.43|0.34|
91779023|NCT03819114|183439094|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.25|0.93|
91779024|NCT03819114|183439094|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.48|||||TWO_SIDED|90.0|0.41|0.56|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.56|0.41|
91779025|NCT03819114|183439096|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.93|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.93|0.60|
91779026|NCT03819114|183439096|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.9|1.36|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.36|0.90|
91779027|NCT03819114|183439096|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.74|||||TWO_SIDED|90.0|1.29|2.33|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.33|1.29|
91779028|NCT03819114|183439096|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.43|||||TWO_SIDED|90.0|0.32|0.58|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.58|0.32|
91779029|NCT03819114|183439097|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.49|0.78|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.49|
91779030|NCT03819114|183439097|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.71|1.1|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.10|0.71|
91779031|NCT03819114|183439097|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.77|||||TWO_SIDED|90.0|1.31|2.4|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.40|1.31|
91779032|NCT03819114|183439097|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.35|||||TWO_SIDED|90.0|0.26|0.47|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.47|0.26|
91585470|NCT02875977|183061993|SUPERIORITY||Odds Ratio (OR)|1.044||||0.9|TWO_SIDED|95.0|0.517|2.11|||Regression, Logistic|The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status||The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling||2.110|0.517|0.90
91585471|NCT02875977|183061994|SUPERIORITY||Z-Score|-1.4262||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling||||0.16
91585472|NCT02875977|183061995|SUPERIORITY||Mean Difference (Final Values)|-4.456|STANDARD_ERROR_OF_MEAN|6.5481||0.5|TWO_SIDED|95.0|-17.6149|8.7028|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling||8.7028|-17.6149|0.50
91585473|NCT00820027|183061996|SUPERIORITY||Difference in Least Squares Mean|-0.49||||0.018|TWO_SIDED|95.0|-0.89|-0.08|||longitudinal data analysis (LDA)|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.08|-0.89|0.018
91585474|NCT00820027|183061996|SUPERIORITY||Difference in Least Squares Mean|-0.54||||0.009|TWO_SIDED|95.0|-0.95|-0.14|||LDA|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.14|-0.95|0.009
91585475|NCT00820027|183061997|SUPERIORITY||Between-Treatment Ratio|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.85|0.56|<0.001
91779033|NCT03819114|183439098|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.5|||||TWO_SIDED|90.0|0.39|0.63|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.63|0.39|
91779034|NCT03819114|183439098|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.69|||||TWO_SIDED|90.0|0.55|0.86|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.86|0.55|
91779035|NCT03819114|183439098|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.8|||||TWO_SIDED|90.0|1.32|2.45|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.32|
91779036|NCT03819114|183439098|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.28|||||TWO_SIDED|90.0|0.2|0.38|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.38|0.20|
91779037|NCT04226742|183439099|SUPERIORITY||Mean Difference (Net)|0.58||||0.79|TWO_SIDED|95.0|-3.71|4.88||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.88|-3.71|0.79
91779038|NCT04226742|183439100|SUPERIORITY||Mean Difference (Net)|0.9||||0.61|TWO_SIDED|95.0|-2.52|4.32||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.32|-2.52|.61
91779039|NCT04226742|183439101|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.088|TWO_SIDED|95.0|-0.05|0.68||Significance threshold of alpha = 0.05|Mixed Models Analysis|||||0.68|-0.05|0.088
91779040|NCT04226742|183439102|SUPERIORITY||Mean Difference (Final Values)|13.68||||0.142|TWO_SIDED|95.0|-4.62|31.99||Threshold for statistical significance of alpha = 0.05|Mixed Models Analysis|||||31.99|-4.62|0.142
91779041|NCT04226742|183439103|SUPERIORITY||Mean Difference (Final Values)|-6.87||||0.109|TWO_SIDED|95.0|-15.28|1.54||Threshold for statistical significance of alpha = .05|Mixed Models Analysis|||||1.54|-15.28|0.109
91779042|NCT04226742|183439104|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.736|TWO_SIDED|95.0|-6.92|4.89|||Mixed Models Analysis|||||4.89|-6.92|0.736
91779043|NCT02492763|183439111|SUPERIORITY||Difference in Least Squares Means|-0.39||||0.126|TWO_SIDED|95.0|-0.88|0.11|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.11|-0.88|0.126
91779044|NCT02492763|183439111|SUPERIORITY||Difference in Least Squares Means|0.6||||0.017|TWO_SIDED|95.0|0.11|1.08|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.08|0.11|0.017
91779045|NCT02492763|183439111|SUPERIORITY||Difference in Least Squares Means|-0.61||||0.018|TWO_SIDED|95.0|-1.12|-0.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.10|-1.12|0.018
91779046|NCT02492763|183439111|SUPERIORITY||Difference in Least Squares Means|0.37||||0.146|TWO_SIDED|95.0|-0.13|0.87|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.87|-0.13|0.146
91779047|NCT02492763|183439111|SUPERIORITY||Difference in the Least Squares Means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.49|-0.48||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.48|-1.49|<0.001
91779048|NCT02492763|183439114|SUPERIORITY||Difference in % vs Placebo|-2.3||||0.301|TWO_SIDED|95.0|-12.1|5.6|||Miettinen & Nurminen method|||||5.6|-12.1|0.301
91779049|NCT02492763|183439114|SUPERIORITY||Difference in % vs Placebo|2.2||||0.573|TWO_SIDED|95.0|-8.1|13.2|||Miettinen & Nurminen method|||||13.2|-8.1|0.573
91779050|NCT02492763|183439114|SUPERIORITY||Difference in % vs Liraglutide|-2.4||||0.295|TWO_SIDED|95.0|-12.4|5.5|||Miettinen & Nurminen method|||||5.5|-12.4|0.295
91779051|NCT02492763|183439114|SUPERIORITY||Difference in % vs Liraglutide|2.2||||0.587|TWO_SIDED|95.0|-8.4|13.2|||Miettinen & Nurminen method|||||13.2|-8.4|0.587
91779052|NCT02492763|183439115|SUPERIORITY||Difference in the LS Means vs. Placebo|6.9|||||TWO_SIDED|95.0|3.42|10.37|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|10.37|3.42|
91585476|NCT00820027|183061997|SUPERIORITY||Between-Treatment Ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.82|0.54|<0.001
91585477|NCT00820027|183061998|OTHER||Difference in Percent|0.5||||0.506|TWO_SIDED|95.0|-3.3|2.5|||Miettinen & Nurminen|||||2.5|-3.3|0.506
91585478|NCT00820027|183061998|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
91585479|NCT00820027|183061998|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
91585480|NCT00820027|183061998|OTHER||Difference in Percent|0.5||||0.316|TWO_SIDED|95.0|-1.3|2.5|||Miettinen & Nurminen|||||2.5|-1.3|0.316
91585481|NCT00820027|183061998|SUPERIORITY||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|1.7|||Miettinen & Nurminen|||||1.7|-1.7|>0.999
91585482|NCT00820027|183061998|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|3.8|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||3.8|-1.7|>0.999
91585483|NCT00820027|183061998|OTHER||Difference in Percent|-0.5||||0.309|TWO_SIDED|95.0|-2.5|1.2|||Miettinen & Nurminen|||||1.2|-2.5|0.309
91585484|NCT00820027|183061999|OTHER||Difference in Percent|-3.2||||0.054|TWO_SIDED|95.0|-9.2|0.1|||Miettinen & Nurminen|||||0.1|-9.2|0.054
91585485|NCT00820027|183061999|OTHER||Difference in Percent|-2.3||||0.209|TWO_SIDED|95.0|-8.4|1.2|||Miettinen & Nurminen|||||1.2|-8.4|0.209
91708776|NCT00551525|183310557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.307|||||TWO_SIDED|95.0|0.364|4.697||||||Modeling the association of clinical T-stage (pT2 vs. pT3 \[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (\<8 vs. 8-10\[reference level\]), and age.||4.697|0.364|
91585486|NCT00820027|183061999|OTHER||Difference in Percent|-2.3||||0.227|TWO_SIDED|95.0|-8.4|1.3|||Miettinen & Nurminen|||||1.3|-8.4|0.227
91585487|NCT00820027|183061999|OTHER||Difference in Percent|-0.9||||0.415|TWO_SIDED|95.0|-3.7|1.6|||Miettinen & Nurminen|||||1.6|-3.7|0.415
91585488|NCT00820027|183061999|OTHER||Difference in Percent|-0.1||||0.965|TWO_SIDED|95.0|-3.0|2.8|||Miettinen & Nurminen|||||2.8|-3.0|0.965
91779053|NCT02492763|183439115|SUPERIORITY||Difference in LS Means vs. Liraglutide|3.84|||||TWO_SIDED|95.0|0.35|7.33|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|7.33|0.35|
91779054|NCT02492763|183439115|SUPERIORITY||Difference in LS Means vs. Placebo|7.7|||||TWO_SIDED|95.0|4.17|11.23|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|11.23|4.17|
91779055|NCT02492763|183439115|SUPERIORITY||Difference in LS Means vs. Liraglutide|4.65|||||TWO_SIDED|95.0|1.11|8.19|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|8.19|1.11|
91779056|NCT02492763|183439116|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.285|TWO_SIDED|95.0|-2.0|0.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.6|-2.0|0.285
91779057|NCT02492763|183439116|SUPERIORITY||Difference in Least Squares Means|0.9||||0.183|TWO_SIDED|95.0|-0.4|2.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.2|-0.4|0.183
91779058|NCT02492763|183439116|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.01|TWO_SIDED|95.0|-3.1|-0.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.4|-3.1|0.010
91779059|NCT02492763|183439116|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.2|-1.5|0.811
91779060|NCT02492763|183439116|SUPERIORITY||Difference in the Least Squares Means|-1.6||||0.018|TWO_SIDED|95.0|-2.9|-0.3||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.3|-2.9|0.018
91779061|NCT02492763|183439117|SUPERIORITY||Difference in Least Squares Means|-8.6||||0.385|TWO_SIDED|95.0|-28.2|10.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||10.9|-28.2|0.385
91779062|NCT02492763|183439117|SUPERIORITY||Difference in Least Squares Means|29.1||||0.004|TWO_SIDED|95.0|9.7|48.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||48.6|9.7|0.004
91779063|NCT02492763|183439117|SUPERIORITY||Difference in Least Squares Means|-29.5||||0.004|TWO_SIDED|95.0|-49.6|-9.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-9.4|-49.6|0.004
91779064|NCT02492763|183439117|SUPERIORITY||Difference in Least Squares Means|8.3||||0.416|TWO_SIDED|95.0|-11.7|28.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||28.2|-11.7|0.416
91779065|NCT02492763|183439117|SUPERIORITY||Difference in the Least Squares Means|-37.8|||<|0.001|TWO_SIDED|95.0|-57.5|-18.0||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-18.0|-57.5|<0.001
91779066|NCT02492763|183439121|SUPERIORITY||Difference in Least Squares Means|-3.7||||0.151|TWO_SIDED|95.0|-8.8|1.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.4|-8.8|0.151
91585489|NCT00820027|183061999|OTHER||Difference in Percent|2.3||||0.227|TWO_SIDED|95.0|-1.3|8.4|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||8.4|-1.3|0.227
91585490|NCT00820027|183061999|OTHER||Difference in Percent|0.8||||0.437|TWO_SIDED|95.0|-1.7|3.6|||Miettinen & Nurminen|||||3.6|-1.7|0.437
91585491|NCT00820027|183062000|OTHER||Difference in Percent|0.5||||0.806|TWO_SIDED|95.0|-5.3|4.5|||Miettinen & Nurminen|||||4.5|-5.3|0.806
91585492|NCT00820027|183062000|OTHER||Difference in Percent|-1.8||||0.278|TWO_SIDED|95.0|-7.4|1.4|||Miettinen & Nurminen|||||1.4|-7.4|0.278
91585493|NCT00820027|183062000|OTHER||Difference in Percent|0.1||||0.971|TWO_SIDED|95.0|-5.7|3.9|||Miettinen & Nurminen|||||3.9|-5.7|0.971
91585494|NCT00820027|183062000|OTHER||Difference in Percent|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.2|||Miettinen & Nurminen|||||4.2|-3.2|0.786
91585495|NCT00820027|183062000|OTHER||Difference in Percent|-1.8||||0.184|TWO_SIDED|95.0|-5.2|1.0|||Miettinen & Nurminen|||||1.0|-5.2|0.184
91585496|NCT00820027|183062000|OTHER||Difference in Percent|-0.1||||0.971|TWO_SIDED|95.0|-3.9|5.7|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||5.7|-3.9|0.971
91585497|NCT00820027|183062000|OTHER||Difference in Percent|-2.3||||0.113|TWO_SIDED|95.0|-5.8|0.6|||Miettinen & Nurminen|||||0.6|-5.8|0.113
91585498|NCT00820027|183062001|OTHER||Difference in Percent|-5.3||||0.365|TWO_SIDED|95.0|-17.0|6.0|||Miettinen & Nurminen|||||6.0|-17.0|0.365
91585499|NCT00820027|183062001|OTHER||Difference in Percent|-7.2||||0.222||95.0|-18.8|4.2|||Miettinen & Nurminen|||||4.2|-18.8|0.222
91585500|NCT00820027|183062001|OTHER||Difference in Percent|-5.5||||0.349|TWO_SIDED|95.0|-17.2|5.9|||Miettinen & Nurminen|||||5.9|-17.2|0.349
91585501|NCT00820027|183062001|OTHER||Difference in Percent|0.2||||0.965|TWO_SIDED|95.0|-8.7|9.0|||Miettinen & Nurminen|||||9.0|-8.7|0.965
91585502|NCT00820027|183062001|OTHER||Difference in Percent|-1.6||||0.718|TWO_SIDED|95.0|-10.5|7.3|||Miettinen & Nurminen|||||7.3|-10.5|0.718
91585503|NCT00820027|183062001|OTHER||Difference in Percent|5.5||||0.349|TWO_SIDED|95.0|-5.9|17.2|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||17.2|-5.9|0.349
91585504|NCT00820027|183062001|OTHER||Difference in Percent|1.8||||0.684|TWO_SIDED|95.0|-7.0|10.6|||Miettinen & Nurminen|||||10.6|-7.0|0.684
91585505|NCT00820027|183062002|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Difference in Least Squares Mean|-0.04|||||TWO_SIDED|95.0|-0.36|0.27||||||||0.27|-0.36|
91585506|NCT00820027|183062002|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.42|0.22||||||||0.22|-0.42|
91585507|NCT00820027|183062003|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
91708777|NCT00551525|183310557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.659|||||TWO_SIDED|95.0|0.217|2.006||||||Modeling the association of Gleason score (\<8 vs. 8-10\[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and age.||2.006|0.217|
91708778|NCT00073008|183310599|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|34.5||||||95.0|13.7|55.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||55.4|13.7|
91585508|NCT00820027|183062003|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.18|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.18|0.85|
91585509|NCT00820027|183062003|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
91585510|NCT02604433|183062005|SUPERIORITY||Odds Ratio (OR)|5.62|||<|0.0001|TWO_SIDED|95.0|2.17|14.53||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||14.53|2.17|<0.0001
91585511|NCT02604433|183062005|SUPERIORITY||Difference in Percentages|16.5|||||TWO_SIDED|95.0|10.0|23.1|||||Luspatercept - Placebo|||23.1|10.0|
91585512|NCT02604433|183062005|SUPERIORITY||Common Risk Difference|16.5||||||95.0|9.9|23.1|||||Luspatercept - Placebo|||23.1|9.9|
91613915|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
91708779|NCT00073008|183310599|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|19.7||||||95.0|2.9|36.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||36.4|2.9|
91585513|NCT02604433|183062006|SUPERIORITY||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|2.27|18.26||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% CIs, and p-value were estimated from the CMH test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate for outcomes 2-4, the testing procedure was implemented strictly in order: the test for this outcome was only conducted when there was evidence showing that erythroid response was achieved in the luspatercept group from Week 13 to Week 24 (primary endpoint).||18.26|2.27|<0.0001
91585514|NCT02604433|183062007|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0402|TWO_SIDED|95.0|0.96|18.79||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.||18.79|0.96|0.0402
91585515|NCT02604433|183062008|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0017|TWO_SIDED|95.0|1.65|86.29||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and achievement of objective in the luspatercept group in outcomes 2+3.||86.29|1.65|0.0017
91585516|NCT02604433|183062009|SUPERIORITY||LSM Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.76|-0.93||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean||-0.93|-1.76|<0.0001
91779067|NCT02492763|183439121|SUPERIORITY||Difference in Least Squares Means|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.1|-6.2|0.682
91779068|NCT02492763|183439121|SUPERIORITY||Difference in Least Squares Means|-2.5||||0.344|TWO_SIDED|95.0|-7.7|2.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.7|-7.7|0.344
91779069|NCT02492763|183439121|SUPERIORITY||Difference in Least Squares Means|0.2||||0.948|TWO_SIDED|95.0|-5.0|5.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||5.4|-5.0|0.948
91779070|NCT02492763|183439121|SUPERIORITY||Difference in the Least Squares Means|-2.7||||0.306|TWO_SIDED|95.0|-7.8|2.5||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||2.5|-7.8|0.306
91779071|NCT02492763|183439122|SUPERIORITY||Difference in Least Squares Means|1.5||||0.347|TWO_SIDED|95.0|-1.7|4.8|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.8|-1.7|0.347
91779072|NCT02492763|183439122|SUPERIORITY||Difference in Least Squares Means|-0.1||||0.963|TWO_SIDED|95.0|-3.3|3.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.2|-3.3|0.963
91779073|NCT02492763|183439122|SUPERIORITY||Difference in Least Squares Means|1.4||||0.394|TWO_SIDED|95.0|-1.9|4.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.7|-1.9|0.394
91779074|NCT02492763|183439122|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.905|TWO_SIDED|95.0|-3.5|3.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.1|-3.5|0.905
91779075|NCT02492763|183439122|SUPERIORITY||Difference in the Least Squares Means|1.6||||0.325|TWO_SIDED|95.0|-1.6|4.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.9|-1.6|0.325
91779076|NCT01193244|183439123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.707|||<|1e-05||95.0|0.626|0.799|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.||0.799|0.626|<0.00001
91585517|NCT02604433|183062010|SUPERIORITY||LS Mean of Difference|0.2||||0.7598|TWO_SIDED|95.0|-1.1|1.51||Significance level of 0.050 for 2-sided tests.|ANCOVA||luspatercept - placebo|Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square||1.51|-1.10|0.7598
91708780|NCT00073008|183310600|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|27.1||||||95.0|11.9|42.3|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||42.3|11.9|
91779077|NCT01193244|183439124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.59755||95.0|0.838|1.107|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio \<1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.107|0.838|0.59755
91585518|NCT02604433|183062011|SUPERIORITY||LS Mean of Difference|-68.0||||0.2552|TWO_SIDED|95.0|-185.8|49.7||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferasirox: Change from baseline at Week 48 LS = least squares||49.7|-185.8|0.2552
91585519|NCT02604433|183062011|SUPERIORITY||LS Mean of Difference|-76.4||||0.7746|TWO_SIDED|95.0|-612.9|460.1||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferiprone: Change from baseline at Week 48 LS = least squares||460.1|-612.9|0.7746
91585520|NCT02604433|183062011|SUPERIORITY||LS Mean of Difference|-147.3||||0.5186|TWO_SIDED|95.0|-673.1|378.5||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LS = least squares||378.5|-673.1|0.5186
91647279|NCT01676311|183186321|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-short delay free recall (SDFR) score, outcome (CVLT-II-SDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.38
91779078|NCT01193244|183439125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|||<|0.001||95.0|1.724|2.721|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline Eastern Cooperative Oncology Group (ECOG) score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio greater than (\>)1 favored orteronel. P-values tested for odds ratio equal to 1.||2.721|1.724|<0.001
91779079|NCT01193244|183439126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.712||||0.001||95.0|1.235|2.373|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline ECOG score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio \> 1 favored orteronel. P-values tested for odds ratio equal to 1.||2.373|1.235|0.001
91779080|NCT01193244|183439127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.885||||0.33906||95.0|0.688|1.138|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.138|0.688|0.33906
91779081|NCT00865566|183439153|OTHER|Score test|Hazard Ratio (HR)|0.73|||<|0.001|TWO_SIDED|95.0|0.63|0.84|||Regression, Cox||HR is vaccine / placebo|Cox proportional hazards model to assess the association between treatment assignment and dropout||0.84|0.63|<0.001
91779082|NCT00865566|183439154|OTHER||Hazard Ratio (HR)|0.77||||0.05|TWO_SIDED|95.0|0.59|1.0||Score test|Regression, Cox||HR is vaccine / placebo|Cox PH model to assess the association between treatment assignment and dropout||1|0.59|0.05
91779083|NCT00865566|183439155|OTHER||Cox Proportional Hazard|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84||Score test|Regression, Cox||HR is vaccine / placebo|Assess the association between treatment assignment and dropout||0.84|0.60|<0.001
91779084|NCT00865566|183439156|OTHER||Hazard Ratio (HR)|1.02||||0.903|TWO_SIDED|95.0|0.73|1.42||Score test|Regression, Cox|Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI|HR is vaccine / placebo|||1.42|0.73|0.903
91779085|NCT00865566|183439157|OTHER||Hazard Ratio (HR)|1.06||||0.783|TWO_SIDED|95.0|0.71|1.58||Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI|Regression, Cox|Score test|HR is vaccine / placebo|||1.58|0.71|0.783
91779086|NCT01039376|183439161|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.7|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.70|0.43|<0.0001
91779087|NCT01039376|183439162|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.68|0.42|<0.0001
91779088|NCT01039376|183439163|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6046|TWO_SIDED|95.0|0.69|1.25|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.25|0.69|0.6046
91779089|NCT01039376|183439165|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0178|TWO_SIDED|95.0|0.62|0.96|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.96|0.62|0.0178
91779090|NCT01039376|183439166|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3136|TWO_SIDED|95.0|0.42|1.32|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.32|0.42|0.3136
91779091|NCT01039376|183439167|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.1603|TWO_SIDED|95.0|0.29|1.19|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.19|0.29|0.1603
91779092|NCT01039376|183439168|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.0199|TWO_SIDED|95.0|-4.04|-0.35||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Disease Effects Scale|||-0.35|-4.04|0.0199
91779093|NCT01039376|183439168|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.0085|TWO_SIDED|95.0|-6.61|-0.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue Scale|||-0.97|-6.61|0.0085
91585521|NCT02604433|183062012|SUPERIORITY||LS Mean of Difference|-342.59|||<|0.0001|TWO_SIDED|95.0|-498.3|-186.87||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least squares||-186.87|-498.30|<0.0001
91585522|NCT02604433|183062013|SUPERIORITY||LS Mean of Difference|0.0||||0.9201|TWO_SIDED|95.0|-0.01|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.01|0.9201
91585523|NCT02604433|183062013|SUPERIORITY||LS Mean of Difference|-0.01||||0.462|TWO_SIDED|95.0|-0.02|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.02|0.4620
91585524|NCT02604433|183062014|SUPERIORITY||LS Mean of Difference|-2.22||||0.0543|TWO_SIDED|95.0|-4.48|0.04||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2\* as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least square||0.04|-4.48|0.0543
91779094|NCT01039376|183439168|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.0642|TWO_SIDED|95.0|-7.37|0.21||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Future Health Scale|||0.21|-7.37|0.0642
91779095|NCT01039376|183439168|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6398|TWO_SIDED|95.0|-1.67|2.72||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Infection Scale|||2.72|-1.67|0.6398
91779096|NCT01039376|183439168|SUPERIORITY||Mean Difference (Final Values)|-4.32||||0.0055|TWO_SIDED|95.0|-7.37|-1.28||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Problems Scale|||-1.28|-7.37|0.0055
91779097|NCT01039376|183439168|SUPERIORITY||Mean Difference (Final Values)|-2.49||||0.0063|TWO_SIDED|95.0|-4.27|-0.71||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Side Effects Scale|||-0.71|-4.27|0.0063
91779098|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.1816|TWO_SIDED|95.0|-3.64|0.69||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Appetite Loss|||0.69|-3.64|0.1816
91779099|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2863|TWO_SIDED|95.0|-1.18|3.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Cognitive Functioning|||3.97|-1.18|0.2863
91779100|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0932|TWO_SIDED|95.0|-4.28|0.33||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Constipation|||0.33|-4.28|0.0932
91779101|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.6533|TWO_SIDED|95.0|-1.67|2.66||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Diarrhoea|||2.66|-1.67|0.6533
91779102|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-2.32||||0.0963|TWO_SIDED|95.0|-5.06|0.42||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Dyspnoea|||0.42|-5.06|0.0963
91779103|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|3.89||||0.0037|TWO_SIDED|95.0|1.27|6.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Emotional Functioning|||6.51|1.27|0.0037
91779104|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-4.63||||0.0013|TWO_SIDED|95.0|-7.45|-1.82||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue|||-1.82|-7.45|0.0013
91779105|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.2902|TWO_SIDED|95.0|-5.02|1.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Financial Difficulties|||1.51|-5.02|0.2902
91779106|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.0606|TWO_SIDED|95.0|-2.49|0.05||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Nausea and Vomiting|||0.05|-2.49|0.0606
91779107|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-3.04||||0.0393|TWO_SIDED|95.0|-5.93|-0.15||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Pain|||-0.15|-5.93|0.0393
91585525|NCT02604433|183062015|SUPERIORITY|||||||0.666||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Health Domain Score - Change from Baseline at Week 24||||0.666
91585526|NCT02604433|183062015|SUPERIORITY|||||||0.384||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Total Score - Change from Baseline at Week 24||||0.384
91585527|NCT02604433|183062016|SUPERIORITY|||||||0.918||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Functioning Domain - Change from Baseline at Week 24||||0.918
91585528|NCT02604433|183062016|SUPERIORITY|||||||0.857||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||General Health Domain - Change from Baseline at Week 24||||0.857
91585529|NCT02604433|183062016|SUPERIORITY|||||||0.839||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||PCS - Change from Baseline at Week 24||||0.839
91585530|NCT02604433|183062019|SUPERIORITY||Odds Ratio (OR)|7.6||||0.0015|TWO_SIDED|95.0|1.8|32.9||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||32.9|1.8|0.0015
91585531|NCT02604433|183062022|SUPERIORITY||Mean Difference (Final Values)|-67.27||||0.0195|TWO_SIDED|95.0|-123.63|-10.91||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 33% Transfusion Burden Reduction||-10.91|-123.63|0.0195
91585532|NCT02604433|183062022|SUPERIORITY||Mean Difference (Final Values)|28.24||||0.7473|TWO_SIDED|95.0|-144.87|201.34||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 50% Transfusion Burden Reduction||201.34|-144.87|0.7473
91585533|NCT01128894|183062037|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide - liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.|Mean Difference (Final Values)|0.21||||0.0846|TWO_SIDED|95.0|0.08|0.34|||ANCOVA|||||0.34|0.08|0.0846
91585534|NCT01128738|183062044|SUPERIORITY_OR_OTHER||Percentage difference|50.2|||<|0.001|TWO_SIDED|95.0|38.1|62.3|||Fisher Exact||Percentage difference was estimated as BTX 50 U minus placebo.|||62.3|38.1|<0.001
91585535|NCT00973362|183062092|SUPERIORITY_OR_OTHER||Sensitivity (%)|75.0|||||TWO_SIDED|95.0|53.1|88.8||||||||88.8|53.1|
91585536|NCT00973362|183062092|SUPERIORITY_OR_OTHER||Specificity (%)|62.6|||||TWO_SIDED|95.0|59.2|65.9||||||||65.9|59.2|
91585537|NCT00973362|183062092|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|4.8|||||TWO_SIDED|95.0|3.4|5.8||||||||5.8|3.4|
91585538|NCT00973362|183062092|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.0|||||TWO_SIDED|95.0|98.1|99.6||||||||99.6|98.1|
91585539|NCT00973362|183062092|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
91585540|NCT00973362|183062092|SUPERIORITY_OR_OTHER||Relative Risk|4.8|||||TWO_SIDED|95.0|1.8|13.1|||||The relative risk of CIN2+ is defined as the \[ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) \] .|||13.1|1.8|
91779108|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|1.81||||0.0968|TWO_SIDED|95.0|-0.33|3.96||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Physical Functioning|||3.96|-0.33|0.0968
91585541|NCT00973362|183062093|SUPERIORITY_OR_OTHER||Sensitivity (%)|84.2|||||TWO_SIDED|95.0|62.4|94.5||||||||94.5|62.4|
91585542|NCT00973362|183062093|SUPERIORITY_OR_OTHER||Specificity (%)|48.7|||||TWO_SIDED|95.0|45.2|52.2||||||||52.2|45.2|
91585543|NCT00973362|183062093|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|3.8|||||TWO_SIDED|95.0|2.9|4.4||||||||4.4|2.9|
91585544|NCT00973362|183062093|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.2|||||TWO_SIDED|95.0|98.1|99.8||||||||99.8|98.1|
91585545|NCT00973362|183062093|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
91585546|NCT00973362|183062093|SUPERIORITY_OR_OTHER||Relative Risk|4.9|||||TWO_SIDED|95.0|1.4|16.7|||||The relative risk of CIN2+ is defined as the \[ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) \] .|||16.7|1.4|
91585547|NCT00973362|183062094|SUPERIORITY_OR_OTHER||Sensitivity(%)|86.8|||||TWO_SIDED|95.0|78.4|92.3||||||||92.3|78.4|
91585548|NCT00973362|183062094|SUPERIORITY_OR_OTHER||Specificty|62.9|||||TWO_SIDED|95.0|59.6|66.0||||||||66.0|59.6|
91585549|NCT00973362|183062094|SUPERIORITY_OR_OTHER||PPV|20.1|||||TWO_SIDED|95.0|18.1|22.0||||||||22.0|18.1|
91585550|NCT00973362|183062094|SUPERIORITY_OR_OTHER||NPV|97.8|||||TWO_SIDED|95.0|96.5|98.8||||||||98.8|96.5|
91585551|NCT00973362|183062094|SUPERIORITY_OR_OTHER||Prevalence (%)|9.7|||||TWO_SIDED|||||||||||||
91585552|NCT00973362|183062095|SUPERIORITY_OR_OTHER||Sensitivity (%)|88.8|||||TWO_SIDED|95.0|80.5|93.8||||||||93.8|80.5|
91585553|NCT00973362|183062095|SUPERIORITY_OR_OTHER||Specificity(%)|55.8|||||TWO_SIDED|95.0|52.3|59.3||||||||59.3|52.3|
91585554|NCT00973362|183062095|SUPERIORITY_OR_OTHER||PPV(%)|18.7|||||TWO_SIDED|95.0|17.0|20.4||||||||20.4|17.0|
91585555|NCT00973362|183062095|SUPERIORITY_OR_OTHER||NPV(%)|97.7|||||TWO_SIDED|95.0|96.2|98.8||||||||98.8|96.2|
91585556|NCT00973362|183062095|SUPERIORITY_OR_OTHER||Prevalence(%)|10.3|||||TWO_SIDED|||||||||||||
91585557|NCT02683941|183062105|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.866|TWO_SIDED|95.0|0.48|1.95|||Log Rank|||The hazard ratio and the 95% confidence interval (CI) were estimated using a Cox proportional hazards model, stratified for interactive web response system (IWRS) tumour subtype (typical versus \[vs\] atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.95|0.48|0.866
91585558|NCT02683941|183062106|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.837|TWO_SIDED|95.0|0.48|1.88|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.88|0.48|0.837
91585559|NCT02683941|183062107|OTHER||Percentage difference|14.0|||||TWO_SIDED|95.0|-10.97|37.86||||||The treatment difference compares lanreotide to placebo (central review). The 95% exact unconditional CI was used for ORR difference.||37.86|-10.97|
91585560|NCT02683941|183062107|OTHER||Percentage difference|2.0|||||TWO_SIDED|95.0|-22.69|26.53||||||The treatment difference compares lanreotide to placebo (local review). The 95% exact unconditional CI was used for ORR difference.||26.53|-22.69|
91585561|NCT02683941|183062108|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.582|TWO_SIDED|95.0|0.5|1.5|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.50|0.50|0.582
91585562|NCT00325039|183062114|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success rate (RMUS-TMUS)|3.0|||||TWO_SIDED|95.0|-3.6|9.6||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||9.6|-3.6|
91585563|NCT00325039|183062115|SUPERIORITY_OR_OTHER||Difference in proportions|-4.1||||0.14||95.0||||This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.|Chi-squared|||Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.||||0.14
91585564|NCT00325039|183062116|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success (RMUS - TMUS)|6.4|||||TWO_SIDED|95.0|-1.6|14.3||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||14.3|-1.6|
91585565|NCT00325039|183062117|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.||||0.47
91585566|NCT00325039|183062118|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||The UDI measure was compared using a two-sample t test.||||0.41
91647280|NCT01676311|183186321|SUPERIORITY|||||||0.42||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-long delay free recall (LDFR) score, outcome (CVLT-II-LDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.42
91585567|NCT00892723|183062167|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.87
91647281|NCT01676311|183186324|SUPERIORITY|||||||0.48||||||A chi-square test with factors of group (Huperzine A, placebo) and occurrence of seizure (yes, no) was performed. A permutation test was the used to assess the effect of Huperzine A on the prevalence of seizures.|Chi-squared test and permutation test|||||||0.48
91647282|NCT01676311|183186325|SUPERIORITY|||||||0.44||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of behavioral side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of behavioral side effects.|Chi-squared test and permutation test|||Behavioral side effects statistical analysis||||0.44
91779109|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.1449|TWO_SIDED|95.0|-0.61|4.17||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Global Health Status/QOL|||4.17|-0.61|0.1449
91779110|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|3.56||||0.0259|TWO_SIDED|95.0|0.43|6.7||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Role Functioning|||6.70|0.43|0.0259
91779111|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.0175|TWO_SIDED|95.0|0.64|6.65||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Functioning|||6.65|0.64|0.0175
91779112|NCT01039376|183439169|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.3209|TWO_SIDED|95.0|-5.33|1.75||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Insomnia|||1.75|-5.33|0.3209
91585568|NCT00892723|183062167|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.86
91585569|NCT00892723|183062167|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.11
91585570|NCT00892723|183062167|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.91
91585571|NCT00892723|183062168|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
91585572|NCT00892723|183062168|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.82
91585573|NCT00892723|183062168|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
91585574|NCT00892723|183062168|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.71
91585575|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.73
91585576|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.94
91585577|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.14
91585578|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.68
91585579|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.56
91585580|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.32
91585581|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.33
91585582|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.65
91585583|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.21
91585584|NCT00892723|183062169|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.90
91647283|NCT01676311|183186325|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of cardiac-respiratory side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Cardiac-respiratory side effects statistical analysis||||0.81
91779113|NCT01039376|183439170|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.011|TWO_SIDED|95.0|0.01|0.06||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Utility Score|||0.06|0.01|0.0110
91779114|NCT01039376|183439170|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.1999|TWO_SIDED|95.0|-0.73|3.49||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Thermometer Score|||3.49|-0.73|0.1999
91585585|NCT00892723|183062170|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.16
91779115|NCT01039376|183439182|SUPERIORITY||Hazard Ratio (HR)|1.547|||||TWO_SIDED|95.0|1.051|2.276|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 6q-, or +12q or 13q-/no abberation|||2.276|1.051|
91779116|NCT01039376|183439182|SUPERIORITY||Hazard Ratio (HR)|9.303|||||TWO_SIDED|95.0|4.934|17.54|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 17p-/no abberation|||17.540|4.934|
91779117|NCT01039376|183439182|SUPERIORITY||Hazard Ratio (HR)|4.219|||||TWO_SIDED|95.0|2.468|7.21|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 11q-/no abberation|||7.210|2.468|
91779118|NCT01039376|183439182|SUPERIORITY||Hazard Ratio (HR)|1.832|||||TWO_SIDED|95.0|1.434|2.339|||||HR estimated for B2 Microglobulin Group 2 with 3500 as cut off: \>3500 ug/L/\<=3500 ug/L|||2.339|1.434|
91779119|NCT01039376|183439182|SUPERIORITY||Hazard Ratio (HR)|0.573|||||TWO_SIDED|95.0|0.432|0.76|||||HR estimated for IgVH Mutational Status 1 Mutated/Unmutated|||0.760|0.432|
91779120|NCT01039376|183439182|SUPERIORITY||Hazard Ratio (HR)|1.301|||||TWO_SIDED|95.0|0.692|2.448|||||HR estimated for VH3-21 Usage Flag Yes/No.|||2.448|0.692|
91779121|NCT00785785|183439188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.466||||0.0081|TWO_SIDED|95.0|1.104|1.945|||Hazard Ratio|||||1.945|1.104|0.0081
91585586|NCT00892723|183062170|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.74
91585587|NCT00892723|183062170|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|||||||0.45
91585588|NCT00892723|183062170|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.079
91585589|NCT00892723|183062170|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.16
91585590|NCT00892723|183062170|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.45
91585591|NCT00426153|183062171|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Rank-sum test|||P values \<0.05 were considered statistically significant.||||0.048
91585592|NCT00426153|183062172|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P values \< 0.05 were considered statistically significant|Rank sum|||||||0.045
91585593|NCT00426153|183062173|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P Values \< 0.05 were considered statistically significant|Rank sum|||||||0.98
91585594|NCT00150969|183062175|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91585595|NCT00150969|183062182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91585596|NCT01630434|183062202|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.091||||0.004|ONE_SIDED|95.0||-0.01|||Wald Method|||||-0.01||0.004
91585597|NCT01630434|183062202|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.038||||0.06|ONE_SIDED|95.0||0.045|||Wald Method|||||0.045||0.06
91779122|NCT01244893|183439194|NON_INFERIORITY_OR_EQUIVALENCE|This study uses -0.05 LogMAR as the non-inferiority margin.|Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.003|||TWO_SIDED|95.0|-0.00092|0.01045|||Mixed Models Analysis||The mean difference is calculated as the test lens - control lens.|"Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale"||0.01045|-0.00092|
91779123|NCT00357552|183439198|NON_INFERIORITY_OR_EQUIVALENCE|Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.|proportion|87.0|||||TWO_SIDED|90.0|81.0|92.0|||confidence interval|Success was determined by whether the lower bound of the 90% exact confidence interval was greater than 65%.|exact confidence interval|The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.||92|81|
91779124|NCT04555616|183439221|OTHER|||||||0.12|||||||Fisher Exact|||Primary outcome analyzed via success rates among groups.||||0.12
91779125|NCT03089281|183439224|SUPERIORITY|||||||0.17|||||||Chi-squared|||||||0.17
91779126|NCT03089281|183439225|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
91779127|NCT03089281|183439226|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
91779128|NCT03089281|183439228|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
91779129|NCT03089281|183439229|SUPERIORITY|||||||0.49|||||||Cochran-Armitage Trend Test|||||||0.49
91779130|NCT03089281|183439230|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91779131|NCT03089281|183439231|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
91779132|NCT03089281|183439232|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
91779133|NCT03089281|183439233|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91779134|NCT03089281|183439234|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
91779135|NCT03089281|183439235|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
91779136|NCT03089281|183439236|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91779137|NCT02282605|183439244|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||||||0.792
91779138|NCT02282605|183439244|SUPERIORITY_OR_OTHER|||||||0.887|||||||Fisher Exact|||||||0.887
91779139|NCT02282605|183439245|SUPERIORITY_OR_OTHER|||||||0.0058||||||For timepoint Day 3 (12 hours after last dose)|Fisher Exact|||||||0.0058
91585598|NCT01630434|183062203|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|-0.015||||0.0003|ONE_SIDED|95.0||0.016|||Wald Method|||||0.016||0.0003
91585599|NCT01630434|183062203|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|0.006||||0.027|ONE_SIDED|95.0||0.044|||Wald Method|||||0.044||0.027
91585600|NCT01630434|183062204|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.035||||0.118|ONE_SIDED|95.0||0.091|||Wald Method|||||0.091||0.118
91779140|NCT02282605|183439247|SUPERIORITY_OR_OTHER|||||||0.028||||||The adjusted means were compared for the two-day treatment period.|ANCOVA|||||||0.028
91779141|NCT02282605|183439247|SUPERIORITY_OR_OTHER||||||<|0.001||||||The adjusted means were compared for the two-day treatment period to discharge.|ANCOVA|||||||<0.001
91779142|NCT02282605|183439247|SUPERIORITY_OR_OTHER|||||||0.005||||||The adjusted means were compared for the two-day treatment period through to discharge|ANCOVA|||||||0.005
91779143|NCT01744977|183439292|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.300
91779144|NCT01744977|183439293|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.|Mean Difference (Final Values)|-0.7||||0.839|TWO_SIDED|95.0|-8.0|6.5||As measured at 12m|Mixed Models Analysis||This value summarizes the full 12 month period so Mean Difference (Final Values) is appropriate.|||6.5|-8.0|0.839
91779145|NCT01750229|183439300|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.||||||0.002
91779146|NCT01746901|183439305|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.5|||<|0.0001|TWO_SIDED|95.0|24.4|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|24.4|<0.0001
91779147|NCT01746901|183439305|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7||||0.0132|TWO_SIDED|95.0|1.6|13.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.7|1.6|0.0132
91779148|NCT01746901|183439305|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
91779149|NCT01746901|183439305|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9|||<|0.0001|TWO_SIDED|95.0|16.8|28.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|16.8|<0.0001
91779150|NCT01746901|183439305|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
91585601|NCT01630434|183062204|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.065||||0.389|ONE_SIDED|95.0||0.124|||Wald Method|||||0.124||0.389
91585602|NCT01630434|183062205|NON_INFERIORITY|The non-inferiority margin is 4%|Difference of proportions|0.043|||||ONE_SIDED|95.0||0.071||||||||0.071||
91521197|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0009|TWO_SIDED|95.0|-1.7|-0.4||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||-0.4|-1.7|0.0009
91585603|NCT01630434|183062205|NON_INFERIORITY|The non-inferiority margin is 4%.|Difference of proportions|0.054|||||ONE_SIDED|95.0||0.087||||||||0.087||
91585604|NCT01630434|183062206|NON_INFERIORITY|The non-inferiority margin is 0.7.|Mean Difference (Final Values)|-0.045|||<|0.0001|ONE_SIDED|95.0||0.047|||t-test, 2 sided|||||0.047||<0.0001
91585605|NCT01054846|183062252|SUPERIORITY_OR_OTHER||z value|2.696|||<|0.01|TWO_SIDED||||||Chi-squared|||Differences between Survey 1 and Survey 2||||<0.01
91585606|NCT01054846|183062252|SUPERIORITY_OR_OTHER||z value|1.351|||>|0.05|TWO_SIDED||||||Chi-squared|||Difference between Survey 1 and Survey 2||||>0.05
91585607|NCT00394953|183062254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.83|3.79|||Chi-squared, Corrected|||The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.||3.79|1.83|<0.0001
91585608|NCT02446886|183062268|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.04|TWO_SIDED||||||t-test, 2 sided|||Previously published reproducibility of our MWF imaging (FAST-T2) has been established to be +/- 2.0 Our hypothesis for this study was the monthly ACTH would lead to greater remylination in acute MS lesions. However, to reach this goal, improvement must be beyond established reproducibility. Note: Since MWF is a fraction of myelin water to total water, it does not have a unit.||||0.04
91585609|NCT02446886|183062273|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.077|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were implemented to assess the variables of interest (lesion MWF) among patients randomized to once versus the monthly ACTH treatment group. The modeling strategy accounts for multiple lesions per patient, repeated measurements (longitudinal analysis) and the following covariates were always considered: patient age, gender, disease duration, individual T2w lesion volume, time on disease modifying treatments (DMT) prior to enrollment, and DMT during the study.|Linear mixed-effects models were implemented|||0.077
91585610|NCT03021954|183062285|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is in the intervention group, we expect a decrease in the area of the levator hiatus at 40 days and 3 months post-partum. Power 90 % confidence interval β = 0.10, α = 0.05||||0.086
91585611|NCT03021954|183062286|EQUIVALENCE|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is platelet rich plasma can maintain or increase levator ani muscle contractions post-partum||||0.29
91585612|NCT02120716|183062344|OTHER|Logistic regression analysis.|Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.6|51.2|||Regression, Logistic|||||51.2|0.6|0.13
91585613|NCT02120716|183062345|SUPERIORITY||Odds Ratio (OR)|11.7|||<|0.015|TWO_SIDED|95.0|4.2|33.0|||Regression, Logistic|||The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).||33.0|4.2|<0.015
91585614|NCT04677179|183062360|SUPERIORITY||Odds Ratio (OR)|0.57||||0.75|TWO_SIDED|95.0|0.03|11.32|||Cochran-Mantel-Haenszel|||||11.32|0.03|0.750
91779151|NCT01746901|183439305|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||18.5|TWO_SIDED|95.0|12.5|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|12.5|18.5
91779152|NCT01746901|183439306|SUPERIORITY_OR_OTHER||LS Mean Difference|49.3|||<|0.0001|TWO_SIDED|95.0|39.2|59.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.5|39.2|<0.0001
91779153|NCT01746901|183439306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9994|TWO_SIDED|95.0|-10.1|10.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.1|-10.1|0.9994
91779154|NCT01746901|183439306|SUPERIORITY_OR_OTHER||LS Mean Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.4|12.1|<0.0001
91779155|NCT01746901|183439306|SUPERIORITY_OR_OTHER||LS Mean Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.0|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|17.0|<0.0001
91779156|NCT01746901|183439306|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0|||<|0.0001|TWO_SIDED|95.0|12.8|33.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.1|12.8|<0.0001
91779157|NCT01746901|183439306|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0005|TWO_SIDED|95.0|8.1|28.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.4|8.1|0.0005
91779158|NCT01746901|183439307|SUPERIORITY_OR_OTHER||LS Mean Difference|63.2|||<|0.0001|TWO_SIDED|95.0|51.5|74.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.9|51.5|<0.0001
91779159|NCT01746901|183439307|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|0.6|0.0402
91779160|NCT01746901|183439307|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|21.1|44.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.7|21.1|<0.0001
91779161|NCT01746901|183439307|SUPERIORITY_OR_OTHER||LS Mean Difference|42.6|||<|0.0001|TWO_SIDED|95.0|30.9|54.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||54.4|30.9|<0.0001
91779162|NCT01746901|183439307|SUPERIORITY_OR_OTHER||LS Mean Difference|32.1|||<|0.0001|TWO_SIDED|95.0|20.3|43.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.9|20.3|<0.0001
91779163|NCT01746901|183439307|SUPERIORITY_OR_OTHER||LS Mean Difference|36.3|||<|0.0001|TWO_SIDED|95.0|24.6|48.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.1|24.6|<0.0001
91779164|NCT01746901|183439308|SUPERIORITY_OR_OTHER||LS Mean Difference|108.0|||<|0.0001|TWO_SIDED|95.0|91.6|124.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.5|91.6|<0.0001
91779165|NCT01746901|183439308|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4125|TWO_SIDED|95.0|-9.6|23.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.3|-9.6|0.4125
91779166|NCT01746901|183439308|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1|||<|0.0001|TWO_SIDED|95.0|29.6|62.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||62.5|29.6|<0.0001
91779167|NCT01746901|183439308|SUPERIORITY_OR_OTHER||LS Mean Difference|68.8|||<|0.0001|TWO_SIDED|95.0|52.4|85.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.2|52.4|<0.0001
91779168|NCT01746901|183439308|SUPERIORITY_OR_OTHER||LS Mean Difference|56.7|||<|0.0001|TWO_SIDED|95.0|40.3|73.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.2|40.3|<0.0001
91779169|NCT01746901|183439308|SUPERIORITY_OR_OTHER||LS Mean Difference|52.6|||<|0.0001|TWO_SIDED|95.0|36.2|69.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||69.0|36.2|<0.0001
91779170|NCT01746901|183439309|SUPERIORITY_OR_OTHER||LS Mean Difference|32.8|||<|0.0001|TWO_SIDED|95.0|21.8|43.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.7|21.8|<0.0001
91779171|NCT01746901|183439309|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.6434|TWO_SIDED|95.0|-8.4|13.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.5|-8.4|0.6434
91585615|NCT04677179|183062360|SUPERIORITY||Odds Ratio (OR)|0.8||||0.838|TWO_SIDED|95.0|0.1|6.21|||Cochran-Mantel-Haenszel|||||6.21|0.10|0.838
91779172|NCT01746901|183439309|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1072|TWO_SIDED|95.0|-2.0|20.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.0|-2.0|0.1072
91779173|NCT01746901|183439309|SUPERIORITY_OR_OTHER||LS Mean Difference|26.3|||<|0.0001|TWO_SIDED|95.0|15.4|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|15.4|<0.0001
91585616|NCT04677179|183062361|SUPERIORITY||Odds Ratio (OR)|0.57||||0.563|TWO_SIDED|95.0|0.1|3.3|||Cochran-Mantel-Haenszel|||||3.30|0.10|0.563
91585617|NCT04677179|183062361|SUPERIORITY||Odds Ratio (OR)|0.78||||0.759|TWO_SIDED|95.0|0.17|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.17|0.759
91585618|NCT04677179|183062362|SUPERIORITY||Odds Ratio (OR)|0.18||||0.163|TWO_SIDED|95.0|0.02|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.02|0.163
91585619|NCT04677179|183062362|SUPERIORITY||Odds Ratio (OR)|0.54||||0.439|TWO_SIDED|95.0|0.11|2.77|||Cochran-Mantel-Haenszel|||||2.77|0.11|0.439
91585620|NCT04677179|183062363|SUPERIORITY||Odds Ratio (OR)|1.29||||0.821|TWO_SIDED|95.0|0.17|9.88|||Cochran-Mantel-Haenszel|||||9.88|0.17|0.821
91779174|NCT01746901|183439309|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|14.7|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|14.7|<0.0001
91779175|NCT01746901|183439309|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0335|TWO_SIDED|95.0|0.9|22.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.9|0.9|0.0335
91779176|NCT01746901|183439310|SUPERIORITY_OR_OTHER||LS Mean Difference|35.0|||<|0.0001|TWO_SIDED|95.0|24.0|46.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.0|24.0|<0.0001
91779177|NCT01746901|183439310|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9811|TWO_SIDED|95.0|-11.1|10.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.8|-11.1|0.9811
91779178|NCT01746901|183439310|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1083|TWO_SIDED|95.0|-2.0|19.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.9|-2.0|0.1083
91779179|NCT01746901|183439310|SUPERIORITY_OR_OTHER||LS Mean Difference|25.9|||<|0.0001|TWO_SIDED|95.0|14.9|36.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.9|14.9|<0.0001
91779180|NCT01746901|183439310|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|12.3|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|12.3|<0.0001
91779181|NCT01746901|183439310|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0408|TWO_SIDED|95.0|0.5|22.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.4|0.5|0.0408
91779182|NCT01746901|183439311|SUPERIORITY_OR_OTHER||LS Mean Difference|36.9|||<|0.0001|TWO_SIDED|95.0|25.2|48.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.7|25.2|<0.0001
91779183|NCT01746901|183439311|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2||||0.5968|TWO_SIDED|95.0|-14.9|8.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.6|-14.9|0.5968
91779184|NCT01746901|183439311|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1471|TWO_SIDED|95.0|-3.1|20.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.4|-3.1|0.1471
91779185|NCT01746901|183439311|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
91779186|NCT01746901|183439311|SUPERIORITY_OR_OTHER||LS Mean Difference|22.4||||0.0002|TWO_SIDED|95.0|10.6|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|10.6|0.0002
91779187|NCT01746901|183439311|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
91779188|NCT01746901|183439313|SUPERIORITY_OR_OTHER||LS Mean Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.6|37.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.4|19.6|<0.0001
91585621|NCT04677179|183062363|SUPERIORITY||Odds Ratio (OR)|1.43||||0.572|TWO_SIDED|95.0|0.37|5.49|||Cochran-Mantel-Haenszel|||||5.49|0.37|0.572
91585622|NCT04677179|183062364|SUPERIORITY||Odds Ratio (OR)|1.18||||0.886|TWO_SIDED|95.0|0.14|10.16|||Cochran-Mantel-Haenszel|||||10.16|0.14|0.886
91585623|NCT04677179|183062364|SUPERIORITY||Odds Ratio (OR)|0.78||||0.784|TWO_SIDED|95.0|0.14|4.18|||Cochran-Mantel-Haenszel|||||4.18|0.14|0.784
91585624|NCT04677179|183062365|SUPERIORITY||Odds Ratio (OR)|0.37||||0.331|TWO_SIDED|95.0|0.06|2.43|||Cochran-Mantel-Haenszel|||||2.43|0.06|0.331
91585625|NCT04677179|183062365|SUPERIORITY||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.52|||Cochran-Mantel-Haenszel|||||2.52|0.10|0.407
91585626|NCT04677179|183062366|SUPERIORITY||Risk Ratio (RR)|1.5||||0.564|TWO_SIDED|95.0|0.38|6.0|||Cochran-Mantel-Haenszel|||||6.00|0.38|0.564
91585627|NCT04677179|183062366|SUPERIORITY||Risk Ratio (RR)|1.51||||0.681|TWO_SIDED|95.0|0.21|10.97|||Cochran-Mantel-Haenszel|||||10.97|0.21|0.681
91779189|NCT01746901|183439313|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6209|TWO_SIDED|95.0|-6.7|11.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|-6.7|0.6209
91779190|NCT01746901|183439313|SUPERIORITY_OR_OTHER||LS Mean Difference|7.5||||0.0997|TWO_SIDED|95.0|-1.4|16.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.3|-1.4|0.0997
91779191|NCT01746901|183439313|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|14.4|32.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.1|14.4|<0.0001
91779192|NCT01746901|183439313|SUPERIORITY_OR_OTHER||LS Mean Difference|16.6||||0.0003|TWO_SIDED|95.0|7.7|25.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|7.7|0.0003
91779193|NCT01746901|183439313|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0036|TWO_SIDED|95.0|4.4|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|4.4|0.0036
91779194|NCT01746901|183439314|SUPERIORITY_OR_OTHER||LS Mean Difference|29.9|||<|0.0001|TWO_SIDED|95.0|21.1|38.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.8|21.1|<0.0001
91779195|NCT01746901|183439314|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4||||0.5951|TWO_SIDED|95.0|-11.2|6.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|-11.2|0.5951
91585628|NCT04677179|183062367|SUPERIORITY||Risk Difference (RD)|3.6||||0.317|TWO_SIDED|95.0|-3.3|10.4|||Cochran-Mantel-Haenszel|||||10.4|-3.3|0.317
91585629|NCT04677179|183062367|SUPERIORITY||Risk Difference (RD)|6.9||||0.238|TWO_SIDED|95.0|-2.3|16.1|||Cochran-Mantel-Haenszel|||||16.1|-2.3|0.238
91779196|NCT01746901|183439314|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0841|TWO_SIDED|95.0|-1.1|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-1.1|0.0841
91779197|NCT01746901|183439314|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.0|28.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.6|11.0|<0.0001
91779198|NCT01746901|183439314|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5||||0.0014|TWO_SIDED|95.0|5.7|23.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.4|5.7|0.0014
91779199|NCT01746901|183439314|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0172|TWO_SIDED|95.0|1.9|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|1.9|0.0172
91779200|NCT01746901|183439315|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4|||<|0.0001|TWO_SIDED|95.0|21.0|39.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.9|21.0|<0.0001
91585630|NCT04677179|183062368|SUPERIORITY||LS Mean Difference|9.71|STANDARD_ERROR_OF_MEAN|10.935||0.378|TWO_SIDED|95.0|-12.17|31.6|||ANCOVA|||||31.60|-12.17|0.378
91779201|NCT01746901|183439315|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9||||0.2166|TWO_SIDED|95.0|-15.4|3.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-15.4|0.2166
91585631|NCT04677179|183062368|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|10.406||0.928|TWO_SIDED|95.0|-21.78|19.88|||ANCOVA|||||19.88|-21.78|0.928
91585632|NCT01257425|183062375|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin defined as 0.8 to 1.25|Ratio of AUC values|0.977|||||TWO_SIDED|90.0|0.88|1.08|||ANCOVA|||||1.08|0.88|
91585633|NCT01257425|183062376|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.932|||||TWO_SIDED|90.0|0.82|1.06|||ANCOVA|||||1.06|0.82|
91585634|NCT01257425|183062377|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.91|||||TWO_SIDED|90.0|0.81|1.02|||ANCOVA|||||1.02|0.81|
91585635|NCT01257425|183062379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||||0.11|-0.09|0.85
91585636|NCT01257425|183062380|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Log Rank|||||||0.98
91585637|NCT01257425|183062381|SUPERIORITY_OR_OTHER|||||||0.84|||||||Log Rank|||||||0.84
91585638|NCT04262817|183062382|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
91585639|NCT04262817|183062382|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.34
91585640|NCT04262817|183062383|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.38
91585641|NCT04262817|183062383|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.85
91585642|NCT04262817|183062384|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.39
91585643|NCT04262817|183062384|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.77
91585644|NCT04262817|183062385|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.43
91585645|NCT04262817|183062385|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.05
91585646|NCT04262817|183062386|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.05
91585647|NCT04262817|183062386|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.04
91585648|NCT04262817|183062387|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
91585649|NCT04262817|183062387|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.38
91585650|NCT04947527|183062388|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.279|TWO_SIDED|95.0|-4.2|1.2|||t-test, 2 sided|||||1.2|-4.2|0.279
91585651|NCT04947527|183062389|SUPERIORITY||Difference in percentages/proportions|-14.4||||0.023|TWO_SIDED|95.0|-26.7|-2.1|||Chi-squared|||||-2.1|-26.7|0.023
91585652|NCT04947527|183062390|SUPERIORITY||Risk Difference (RD)|-0.09||||0.133|TWO_SIDED||||||Fisher Exact|||||||0.133
91585653|NCT06609135|183062400|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.045
91585654|NCT06609135|183062401|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.045
91585655|NCT06609135|183062402|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.49
91585656|NCT06609135|183062403|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.49
91585657|NCT06609135|183062404|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.56
91779202|NCT01746901|183439315|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0777|TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-1.0|0.0777
91779203|NCT01746901|183439315|SUPERIORITY_OR_OTHER||LS Mean Difference|16.0||||0.0011|TWO_SIDED|95.0|6.5|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|6.5|0.0011
91779204|NCT01746901|183439315|SUPERIORITY_OR_OTHER||LS Mean Difference|12.7||||0.0086|TWO_SIDED|95.0|3.3|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|3.3|0.0086
91779205|NCT01746901|183439315|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0775|TWO_SIDED|95.0|-0.9|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-0.9|0.0775
91779206|NCT01746901|183439317|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|48.8|73.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.6|48.8|<0.0001
91779207|NCT01746901|183439317|SUPERIORITY_OR_OTHER||LS Mean Difference|18.8||||0.0032|TWO_SIDED|95.0|6.4|31.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.2|6.4|0.0032
91779208|NCT01746901|183439317|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
91779209|NCT01746901|183439317|SUPERIORITY_OR_OTHER||LS Mean Difference|47.2|||<|0.0001|TWO_SIDED|95.0|34.8|59.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.6|34.8|<0.0001
91779210|NCT01746901|183439317|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|61.1|86.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||86.0|61.1|<0.0001
91779211|NCT01746901|183439317|SUPERIORITY_OR_OTHER||LS Mean Difference|38.4|||<|0.0001|TWO_SIDED|95.0|26.0|50.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.8|26.0|<0.0001
91779212|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9|||<|0.0001|TWO_SIDED|95.0|36.0|51.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.8|36.0|<0.0001
91779213|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.4154|TWO_SIDED|95.0|-4.6|11.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.2|-4.6|0.4154
91779214|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|13.9|29.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|13.9|<0.0001
91779215|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|||<|0.0001|TWO_SIDED|95.0|17.5|33.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.3|17.5|<0.0001
91779216|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|12.3|28.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|12.3|<0.0001
91779217|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|18.9|||<|0.0001|TWO_SIDED|95.0|11.0|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.0|<0.0001
91779218|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|114.2|||<|0.0001|TWO_SIDED|95.0|97.1|131.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||131.3|97.1|<0.0001
91779219|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3985|TWO_SIDED|95.0|-9.8|24.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.4|-9.8|0.3985
91779220|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.8|38.5|<0.0001
91779221|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|65.9|||<|0.0001|TWO_SIDED|95.0|48.8|83.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.0|48.8|<0.0001
91585658|NCT06609135|183062405|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.56
91585659|NCT06609135|183062406|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.09
91585660|NCT06609135|183062407|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.09
91779222|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.7|38.5|<0.0001
91779223|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|54.1|||<|0.0001|TWO_SIDED|95.0|37.0|71.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.2|37.0|<0.0001
91779224|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|302.8|||<|0.0001|TWO_SIDED|95.0|248.8|356.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.8|248.8|<0.0001
91779225|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|47.8||||0.0824|TWO_SIDED|95.0|-6.2|101.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.7|-6.2|0.0824
91779226|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|188.5|||<|0.0001|TWO_SIDED|95.0|134.6|242.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||242.5|134.6|<0.0001
91779227|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|162.0|||<|0.0001|TWO_SIDED|95.0|108.0|216.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||216.0|108.0|<0.0001
91779228|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|141.9|||<|0.0001|TWO_SIDED|95.0|87.9|195.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||195.8|87.9|<0.0001
91779229|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|135.7|||<|0.0001|TWO_SIDED|95.0|81.7|189.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.6|81.7|<0.0001
91779230|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|287.6|||<|0.0001|TWO_SIDED|95.0|219.1|356.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.1|219.1|<0.0001
91779231|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|101.4||||0.004|TWO_SIDED|95.0|32.9|169.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||169.8|32.9|0.0040
91779232|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|218.5|||<|0.0001|TWO_SIDED|95.0|150.0|287.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||287.0|150.0|<0.0001
91779233|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|170.5|||<|0.0001|TWO_SIDED|95.0|102.0|239.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||239.0|102.0|<0.0001
91779234|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|158.6|||<|0.0001|TWO_SIDED|95.0|90.1|227.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.1|90.1|<0.0001
91779235|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|152.2|||<|0.0001|TWO_SIDED|95.0|83.7|220.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||220.7|83.7|<0.0001
91779236|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0002|TWO_SIDED|95.0|90.1|281.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.8|90.1|0.0002
91779237|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|205.0|||<|0.0001|TWO_SIDED|95.0|109.2|300.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||300.8|109.2|<0.0001
91779238|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|221.0|||<|0.0001|TWO_SIDED|95.0|125.2|316.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.7|125.2|<0.0001
91779239|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0006|TWO_SIDED|95.0|74.1|265.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||265.8|74.1|0.0006
91779240|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|185.7||||0.0002|TWO_SIDED|95.0|89.9|281.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.5|89.9|0.0002
91779241|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|144.9||||0.0033|TWO_SIDED|95.0|49.1|240.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.8|49.1|0.0033
91779242|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0017|TWO_SIDED|95.0|65.2|274.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||274.9|65.2|0.0017
91779243|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|211.4||||0.0001|TWO_SIDED|95.0|106.6|316.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.2|106.6|0.0001
91779244|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|219.2|||<|0.0001|TWO_SIDED|95.0|114.5|324.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||324.0|114.5|<0.0001
91779245|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|162.2||||0.0027|TWO_SIDED|95.0|57.3|267.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||267.0|57.3|0.0027
91585661|NCT06609135|183062408|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.44
91708781|NCT00073008|183310600|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|18.3||||||95.0|3.9|32.6|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||32.6|3.9|
91779246|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0006|TWO_SIDED|95.0|81.1|290.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.7|81.1|0.0006
91779247|NCT01746901|183439318|SUPERIORITY_OR_OTHER||LS Mean Difference|135.5||||0.0116|TWO_SIDED|95.0|30.7|240.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.4|30.7|0.0116
91585662|NCT06609135|183062409|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.44
91779248|NCT01746901|183439319|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.3|-1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.5|-4.3|<0.0001
91779249|NCT01746901|183439319|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.0001|TWO_SIDED|95.0|1.4|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.4|0.0001
91779250|NCT01746901|183439319|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7005|TWO_SIDED|95.0|-1.7|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.7|0.7005
91779251|NCT01746901|183439319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.844|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8440
91779252|NCT01746901|183439319|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7295|TWO_SIDED|95.0|-1.6|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.6|0.7295
91779253|NCT01746901|183439319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.8757|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8757
91779254|NCT01746901|183439320|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|47.4|72.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.9|47.4|<0.0001
91779255|NCT01746901|183439320|SUPERIORITY_OR_OTHER||LS Mean Difference|12.6||||0.0514|TWO_SIDED|95.0|-0.1|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|-0.1|0.0514
91779256|NCT01746901|183439320|SUPERIORITY_OR_OTHER||LS Mean Difference|29.7|||<|0.0001|TWO_SIDED|95.0|17.0|42.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||42.4|17.0|<0.0001
91779257|NCT01746901|183439320|SUPERIORITY_OR_OTHER||LS Mean Difference|43.0|||<|0.0001|TWO_SIDED|95.0|30.3|55.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.8|30.3|<0.0001
91779258|NCT01746901|183439320|SUPERIORITY_OR_OTHER||LS Mean Difference|33.7|||<|0.0001|TWO_SIDED|95.0|21.0|46.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|21.0|<0.0001
91779259|NCT01746901|183439320|SUPERIORITY_OR_OTHER||LS Mean Difference|36.4|||<|0.0001|TWO_SIDED|95.0|23.7|49.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.1|23.7|<0.0001
91585663|NCT06609135|183062410|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.59
91779260|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|39.5|||<|0.0001|TWO_SIDED|95.0|31.8|47.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.2|31.8|<0.0001
91779261|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.2739|TWO_SIDED|95.0|-3.4|12.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.0|-3.4|0.2739
91779262|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4|||<|0.0001|TWO_SIDED|95.0|8.7|24.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|8.7|<0.0001
91779263|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4|||<|0.0001|TWO_SIDED|95.0|19.7|35.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.0|19.7|<0.0001
91779264|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|20.5|||<|0.0001|TWO_SIDED|95.0|12.8|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|12.8|<0.0001
91779265|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|12.0|27.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.4|12.0|<0.0001
91779266|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|104.7|||<|0.0001|TWO_SIDED|95.0|87.7|121.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.8|87.7|<0.0001
91779267|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.4003|TWO_SIDED|95.0|-9.8|24.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.3|-9.8|0.4003
91647284|NCT01676311|183186325|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of dermatological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of dermatological side effects.|Chi-squared test and permutation test|||Dermatological side effects statistical analysis||||0.81
91585664|NCT06609135|183062411|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.59
91585665|NCT00826111|183062482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0085|STANDARD_ERROR_OF_MEAN|0.0534||0.88|TWO_SIDED|95.0|-0.139|0.0122|||t-test, 2 sided|||||.01220|-0.1390|0.88
91585666|NCT00826111|183062483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.112||0.79|TWO_SIDED|95.0|-0.286|0.224|||t-test, 2 sided|||||0.224|-0.286|0.79
91585667|NCT00826111|183062484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0222|STANDARD_ERROR_OF_MEAN|0.0128||0.16|TWO_SIDED|95.0|-0.58|0.0136|||t-test, 2 sided|||||.0136|-0.580|0.16
91585668|NCT00826111|183062485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.515||0.29|TWO_SIDED|95.0|-1.35|2.77|||t-test, 2 sided|||||2.77|-1.35|0.29
91647285|NCT01676311|183186325|SUPERIORITY|||||||0.73||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of gastrointestinal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Gastrointestinal side effects statistical analysis||||0.73
91585669|NCT00826111|183062486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0048|STANDARD_ERROR_OF_MEAN|0.005||0.37|TWO_SIDED|95.0|-0.0077|0.0174|||t-test, 2 sided|||||0.0174|-0.0077|0.37
91585670|NCT00826111|183062487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0056|STANDARD_ERROR_OF_MEAN|0.0042||0.21|TWO_SIDED|95.0|-0.0037|0.1481|||t-test, 2 sided|||||0.1481|-0.0037|0.21
91585671|NCT00826111|183062488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.35|STANDARD_ERROR_OF_MEAN|3.94||0.1|TWO_SIDED|95.0|-1.76|16.46|||t-test, 2 sided|||||16.46|-1.76|0.10
91708782|NCT00808470|183310616|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||15 minutes after exposure||||0.58
91521198|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||-1.1|-2.4|<0.0001
91708783|NCT00808470|183310616|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||1 hour and 15 minutes after exposure||||0.39
91521199|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||-1.2|-2.4|<0.0001
91521200|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.0|-0.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||-0.9|-2.0|<0.0001
91585672|NCT00826111|183062489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.06||0.89|TWO_SIDED|95.0|-9.31|10.51|||t-test, 2 sided|||||10.51|-9.31|0.89
91708784|NCT00808470|183310616|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||2 Hours 15 minutes after exposure||||.51
91585673|NCT00826111|183062490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.78||0.66|TWO_SIDED|95.0|-10.31|6.91|||t-test, 2 sided|||||6.91|-10.31|0.66
91779268|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|43.6|||<|0.0001|TWO_SIDED|95.0|26.6|60.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||60.7|26.6|<0.0001
91779269|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|68.4|||<|0.0001|TWO_SIDED|95.0|51.3|85.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.4|51.3|<0.0001
91779270|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|54.3|||<|0.0001|TWO_SIDED|95.0|37.3|71.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.4|37.3|<0.0001
91779271|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|53.0|||<|0.0001|TWO_SIDED|95.0|36.0|70.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|36.0|<0.0001
91779272|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|292.5|||<|0.0001|TWO_SIDED|95.0|240.0|345.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||345.1|240.0|<0.0001
91779273|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|32.2||||0.2277|TWO_SIDED|95.0|-20.3|84.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.7|-20.3|0.2277
91779274|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|173.1|||<|0.0001|TWO_SIDED|95.0|120.5|225.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.6|120.5|<0.0001
91779275|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|151.7|||<|0.0001|TWO_SIDED|95.0|99.1|204.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||204.2|99.1|<0.0001
91779276|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|129.8|||<|0.0001|TWO_SIDED|95.0|77.2|182.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||182.3|77.2|<0.0001
91779277|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|122.6|||<|0.0001|TWO_SIDED|95.0|70.0|175.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||175.1|70.0|<0.0001
91779278|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|295.3|||<|0.0001|TWO_SIDED|95.0|228.3|362.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||362.2|228.3|<0.0001
91779279|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|69.6||||0.0416|TWO_SIDED|95.0|2.7|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|2.7|0.0416
91779280|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|204.4|||<|0.0001|TWO_SIDED|95.0|137.5|271.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||271.3|137.5|<0.0001
91779281|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|160.5|||<|0.0001|TWO_SIDED|95.0|93.5|227.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.4|93.5|<0.0001
91779282|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|133.0||||0.0001|TWO_SIDED|95.0|66.1|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|66.1|0.0001
91779283|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|140.1|||<|0.0001|TWO_SIDED|95.0|73.1|207.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.0|73.1|<0.0001
91779284|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|219.5|||<|0.0001|TWO_SIDED|95.0|127.6|311.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||311.3|127.6|<0.0001
91779285|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|145.0||||0.0022|TWO_SIDED|95.0|53.2|236.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.8|53.2|0.0022
91779286|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|200.2|||<|0.0001|TWO_SIDED|95.0|108.4|292.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||292.0|108.4|<0.0001
91585674|NCT00402363|183062547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.263|TWO_SIDED|95.0|0.9|1.46|||Regression, Cox|||||1.46|0.90|0.263
91585675|NCT00402363|183062548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.089|TWO_SIDED|95.0|0.92|2.92|||Log Rank|||||2.92|0.92|0.089
91585676|NCT00402363|183062548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.081|TWO_SIDED|95.0|0.98|1.52|||Regression, Cox|||||1.52|0.98|0.081
91779287|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|164.3||||0.0005|TWO_SIDED|95.0|72.4|256.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||256.1|72.4|0.0005
91779288|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|146.6||||0.0019|TWO_SIDED|95.0|54.8|238.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||238.4|54.8|0.0019
91521201|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.5|-0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||-0.5|-1.5|0.0001
91647286|NCT01676311|183186325|SUPERIORITY|||||||0.54||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of genitourinary/neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects|Chi-squared test and permutation test|||Genitourinary/neurological side effects statistical analysis||||0.54
91585677|NCT00402363|183062549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.213|TWO_SIDED|95.0|0.91|1.49|||Regression, Cox|||||1.49|0.91|0.213
91779289|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|132.7||||0.0049|TWO_SIDED|95.0|40.8|224.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.5|40.8|0.0049
91779290|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|209.3|||<|0.0001|TWO_SIDED|95.0|108.3|310.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||310.3|108.3|<0.0001
91779291|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|145.7||||0.005|TWO_SIDED|95.0|44.7|246.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|44.7|0.0050
91779292|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|200.7||||0.0001|TWO_SIDED|95.0|99.7|301.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.6|99.7|0.0001
91779293|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3||||0.003|TWO_SIDED|95.0|53.3|255.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||255.3|53.3|0.0030
91779294|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|146.8||||0.0046|TWO_SIDED|95.0|45.9|247.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||247.8|45.9|0.0046
91779295|NCT01746901|183439321|SUPERIORITY_OR_OTHER||LS Mean Difference|123.3||||0.0171|TWO_SIDED|95.0|22.3|224.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.3|22.3|0.0171
91779296|NCT01746901|183439322|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0016|TWO_SIDED|95.0|-3.7|-0.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.9|-3.7|0.0016
91779297|NCT01746901|183439322|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0105|TWO_SIDED|95.0|0.4|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.4|0.0105
91779298|NCT01746901|183439322|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7259|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.7|0.7259
91779299|NCT01746901|183439322|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7813|TWO_SIDED|95.0|-1.6|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.6|0.7813
91779300|NCT01746901|183439322|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5235|TWO_SIDED|95.0|-1.9|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-1.9|0.5235
91779301|NCT01746901|183439322|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8512|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.6|0.8512
91779302|NCT01746901|183439323|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0883|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0883
91779303|NCT01746901|183439323|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0241|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0241
91779304|NCT01746901|183439323|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0235|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0235
91779305|NCT01746901|183439323|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0901|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0901
91779306|NCT01746901|183439323|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8||||0.1313|TWO_SIDED|95.0|-3.0|22.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.6|-3.0|0.1313
91779307|NCT01746901|183439323|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0982|TWO_SIDED|95.0|-2.0|23.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.6|-2.0|0.0982
91779308|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0351|TWO_SIDED|95.0|0.2|6.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|0.2|0.0351
91779309|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8751|TWO_SIDED|95.0|-3.3|2.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-3.3|0.8751
91779310|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0795|TWO_SIDED|95.0|-0.3|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-0.3|0.0795
91779311|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8382|TWO_SIDED|95.0|-2.7|3.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.4|-2.7|0.8382
91585678|NCT00402363|183062549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.171|TWO_SIDED|95.0|0.83|2.69|||Log Rank|||||2.69|0.83|0.171
91585679|NCT00402363|183062550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.082|TWO_SIDED|95.0|0.98|1.53|||Regression, Cox|||||1.53|0.98|0.082
91585680|NCT00402363|183062551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.331|TWO_SIDED|95.0|0.89|1.4|||Regression, Cox|||||1.40|0.89|0.331
91585681|NCT00402363|183062551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.297|TWO_SIDED|95.0|0.79|2.11|||Log Rank|||||2.11|0.79|0.297
91585682|NCT00402363|183062552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.168|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.168
91585683|NCT00402363|183062553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.27|TWO_SIDED|95.0|0.9|1.43|||Regression, Cox|||||1.43|0.90|0.270
91585684|NCT00402363|183062553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.486|TWO_SIDED|95.0|0.73|1.95|||Log Rank|||||1.95|0.73|0.486
91585685|NCT00402363|183062554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.167|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.167
91585686|NCT00402363|183062555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.565|TWO_SIDED|95.0|0.81|1.47|||Regression, Cox|||||1.47|0.81|0.565
91585687|NCT00402363|183062555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.68||||0.103|TWO_SIDED|95.0|0.89|3.15|||Log Rank|||||3.15|0.89|0.103
91585688|NCT00402363|183062556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.185|TWO_SIDED|95.0|0.92|1.56|||Regression, Cox|||||1.56|0.92|0.185
91585689|NCT00402363|183062557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.461|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.461
91585690|NCT00402363|183062557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.206|TWO_SIDED|95.0|0.79|2.86|||Log Rank|||||2.86|0.79|0.206
91585691|NCT00402363|183062558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.188|TWO_SIDED|95.0|0.92|1.57|||Regression, Cox|||||1.57|0.92|0.188
91585692|NCT00402363|183062559|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.07||||0.29|TWO_SIDED|95.0|-0.09|2.08|||non-parametric ANCOVA|||||2.08|-0.09|0.290
91585693|NCT00402363|183062559|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.063||||0.479|TWO_SIDED|95.0|-0.08|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-0.08|0.479
91585694|NCT00402363|183062559|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.039||||0.218|TWO_SIDED|95.0|-0.06|1.49|||non-parametric ANCOVA|||||1.49|-0.06|0.218
91585695|NCT00402363|183062560|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.321||||0.218|TWO_SIDED|95.0|-0.18|2.21|||non-parametric ANCOVA|||||2.21|-0.18|0.218
91585696|NCT00402363|183062560|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.216||||0.188|TWO_SIDED|95.0|-0.14|3.14|||Wilcoxon (Mann-Whitney)|||||3.14|-0.14|0.188
91585697|NCT00402363|183062560|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.181||||0.097|TWO_SIDED|95.0|-0.1|2.1|||non-parametric ANCOVA|||||2.10|-0.10|0.097
91585698|NCT00402363|183062561|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.242||||0.239|TWO_SIDED|95.0|-0.19|2.17|||non-parametric ANCOVA|||||2.17|-0.19|0.239
91585699|NCT00402363|183062561|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.249||||0.152|TWO_SIDED|95.0|-0.09|4.31|||Wilcoxon (Mann-Whitney)|||||4.31|-0.09|0.152
91585700|NCT00402363|183062561|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.2||||0.094|TWO_SIDED|95.0|-0.08|2.11|||non-parametric ANCOVA|||||2.11|-0.08|0.094
91585701|NCT00568321|183062563|SUPERIORITY||LS Mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.43||0.687|TWO_SIDED|90.0|-0.5|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.50|0.687
91585702|NCT00568321|183062563|SUPERIORITY||LS Mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.44||0.111|TWO_SIDED|90.0|-1.25|0.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||LS mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.19|-1.25|0.111
91585703|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.41||0.399|TWO_SIDED|90.0|-0.79|0.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.58|-0.79|0.399
91585704|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.42||0.189|TWO_SIDED|90.0|-1.06|0.32|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.32|-1.06|0.189
91585705|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.42||0.802|TWO_SIDED|90.0|-0.33|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.33|0.802
91585706|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.582|TWO_SIDED|90.0|-0.61|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.61|0.582
91585707|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.789|TWO_SIDED|90.0|-0.36|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.36|0.789
91585708|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.42||0.29|TWO_SIDED|90.0|-0.94|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-0.94|0.290
91585709|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.568|TWO_SIDED|90.0|-0.65|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.65|0.568
91647287|NCT01676311|183186325|SUPERIORITY|||||||0.27||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of hematological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Hematological side effects statistical analysis||||0.27
91647288|NCT01676311|183186325|SUPERIORITY|||||||0.41||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of musculoskeletal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Musculoskeletal side effects statistical analysis||||0.41
91647289|NCT01676311|183186325|SUPERIORITY|||||||1||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Neurological side effects statistical analysis||||1.00
91585710|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.45||0.116|TWO_SIDED|90.0|-1.27|0.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.20|-1.27|0.116
91585711|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.46||0.218|TWO_SIDED|90.0|-1.11|0.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.40|-1.11|0.218
91647290|NCT03398928|183186350|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91647291|NCT03398928|183186351|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91585712|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.261|TWO_SIDED|90.0|-1.06|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.06|0.261
91585713|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|90.0|-1.11|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.11|0.252
91585714|NCT00568321|183062564|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.49||0.182|TWO_SIDED|90.0|-1.26|0.36|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.36|-1.26|0.182
91585715|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.39||0.683|TWO_SIDED|90.0|-0.46|0.84|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.84|-0.46|0.683
91585716|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.31|TWO_SIDED|90.0|-0.85|0.46|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.46|-0.85|0.310
91585717|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.37||0.668|TWO_SIDED|90.0|-0.46|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.46|0.668
91585718|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.38||0.165|TWO_SIDED|90.0|-0.99|0.26|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.26|-0.99|0.165
91585719|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.36||0.546|TWO_SIDED|90.0|-0.55|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-0.55|0.546
91647292|NCT03398928|183186354|SUPERIORITY|||||||0.002||||||The statistical analysis applies to all the rows|Chi-squared|||||||0.002
91585720|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.36||0.19|TWO_SIDED|90.0|-0.92|0.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.28|-0.92|0.190
91585721|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.35||0.467|TWO_SIDED|90.0|-0.6|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-0.60|0.467
91647293|NCT03398928|183186355|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
91647294|NCT04529499|183186361|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
91585722|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.35||0.153|TWO_SIDED|90.0|-0.94|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-0.94|0.153
91585723|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.41||0.632|TWO_SIDED|90.0|-0.54|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.54|0.632
91585724|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.094|TWO_SIDED|90.0|-1.22|0.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.14|-1.22|0.094
91779312|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.0289|TWO_SIDED|95.0|0.4|6.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|0.4|0.0289
91779313|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7878|TWO_SIDED|95.0|-2.6|3.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-2.6|0.7878
91779314|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0019|TWO_SIDED|95.0|5.6|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|5.6|0.0019
91779315|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.821|TWO_SIDED|95.0|-8.1|10.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.3|-8.1|0.821
91779316|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0094|TWO_SIDED|95.0|3.1|21.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.5|3.1|0.0094
91779317|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4454|TWO_SIDED|95.0|-5.6|12.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.8|-5.6|0.4454
91779318|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9||||0.0934|TWO_SIDED|95.0|-1.3|17.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-1.3|0.0934
91779319|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.1358|TWO_SIDED|95.0|-2.2|16.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.2|-2.2|0.1358
91779320|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|59.8||||0.0004|TWO_SIDED|95.0|27.0|92.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||92.7|27.0|0.0004
91779321|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7||||0.2365|TWO_SIDED|95.0|-13.1|52.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||52.6|-13.1|0.2365
91779322|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0091|TWO_SIDED|95.0|11.1|76.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||76.7|11.1|0.0091
91779323|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|35.7||||0.0335|TWO_SIDED|95.0|2.8|68.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||68.5|2.8|0.0335
91779324|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8||||0.0661|TWO_SIDED|95.0|-2.1|63.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.6|-2.1|0.0661
91779325|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.1074|TWO_SIDED|95.0|-5.9|59.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.8|-5.9|0.1074
91779326|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|55.3||||0.0064|TWO_SIDED|95.0|15.8|94.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.9|15.8|0.0064
91779327|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8||||0.0543|TWO_SIDED|95.0|-0.7|78.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.3|-0.7|0.0543
91779328|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|50.2||||0.0131|TWO_SIDED|95.0|10.7|89.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.7|10.7|0.0131
91779329|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0297|TWO_SIDED|95.0|4.4|83.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.5|4.4|0.0297
91779330|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|41.3||||0.0407|TWO_SIDED|95.0|1.8|80.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.8|1.8|0.0407
91585725|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.39||0.468|TWO_SIDED|90.0|-0.68|0.61|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.61|-0.68|0.468
91585726|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.167|TWO_SIDED|90.0|-1.03|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.03|0.167
91585727|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.394|TWO_SIDED|90.0|-0.72|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-0.72|0.394
91585728|NCT00568321|183062565|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.38||0.138|TWO_SIDED|90.0|-1.04|0.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.21|-1.04|0.138
91585729|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.55||0.764|TWO_SIDED|90.0|-0.51|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.51|0.764
91585730|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.55||0.75|TWO_SIDED|90.0|-0.54|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.54|0.750
91585731|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|90.0|-0.46|1.03|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.03|-0.46|0.734
91585732|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.45||0.514|TWO_SIDED|90.0|-0.73|0.77|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.77|-0.73|0.514
91585733|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|1.89||0.765|TWO_SIDED|90.0|-1.76|4.5|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.50|-1.76|0.765
91647295|NCT04529499|183186361|SUPERIORITY||Cox Proportional Hazard|0.991|||||TWO_SIDED|95.0|0.767|1.28|||||Favipiravir + supportive care in numerator and Placebo+ Supportive care in denominator for CPH ratio analysis|||1.280|0.767|
91647296|NCT04529499|183186362|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
91585734|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.9||0.646|TWO_SIDED|90.0|-2.43|3.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.86|-2.43|0.646
91585735|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|90.0|-0.22|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.22|0.895
91585736|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.56||0.776|TWO_SIDED|90.0|-0.5|1.34|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.34|-0.50|0.776
91585737|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.45||0.944|TWO_SIDED|90.0|-0.03|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.03|0.944
91585738|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.46||0.835|TWO_SIDED|90.0|-0.31|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.31|0.835
91585739|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|3.23|STANDARD_ERROR_OF_MEAN|1.9||0.955|TWO_SIDED|90.0|0.09|6.37|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||6.37|0.09|0.955
91585740|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.93||0.884|TWO_SIDED|90.0|-0.88|5.49|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.49|-0.88|0.884
91585741|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.56||0.737|TWO_SIDED|90.0|-0.57|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.57|0.737
91585742|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.56||0.628|TWO_SIDED|90.0|-0.74|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.74|0.628
91585743|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.46||0.925|TWO_SIDED|90.0|-0.1|1.43|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.43|-0.10|0.925
91585744|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.46||0.518|TWO_SIDED|90.0|-0.75|0.79|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.79|-0.75|0.518
91585745|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.93||0.81|TWO_SIDED|90.0|-1.49|4.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.88|-1.49|0.810
91585746|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.94||0.6|TWO_SIDED|90.0|-2.72|3.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.70|-2.72|0.600
91585747|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.58||0.651|TWO_SIDED|90.0|-0.73|1.18|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.18|-0.73|0.651
91585748|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.59||0.342|TWO_SIDED|90.0|-1.21|0.73|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.73|-1.21|0.342
91708785|NCT00808470|183310616|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||3 hours, 15 minutes after exposure||||.36
91708786|NCT00808470|183310616|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||1 day after exposure||||.86
91585749|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.768|TWO_SIDED|90.0|-0.44|1.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.14|-0.44|0.768
91585750|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.48||0.211|TWO_SIDED|90.0|-1.19|0.41|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.41|-1.19|0.211
91585751|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.99||0.61|TWO_SIDED|90.0|-2.73|3.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.85|-2.73|0.610
91585752|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.02||0.241|TWO_SIDED|90.0|-4.76|1.91|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.91|-4.76|0.241
91585753|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.59||0.789|TWO_SIDED|90.0|-0.5|1.45|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.45|-0.50|0.789
91585754|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.6||0.57|TWO_SIDED|90.0|-0.88|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.88|0.570
91585755|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.49||0.782|TWO_SIDED|90.0|-0.43|1.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.19|-0.43|0.782
91585756|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.49||0.295|TWO_SIDED|90.0|-1.08|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-1.08|0.295
91585757|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|1.75|STANDARD_ERROR_OF_MEAN|2.04||0.804|TWO_SIDED|90.0|-1.62|5.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.11|-1.62|0.804
91585758|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|2.06||0.655|TWO_SIDED|90.0|-2.58|4.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.22|-2.58|0.655
91647297|NCT01494649|183186380|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1||||0.2294|TWO_SIDED|95.0|-0.26|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|The model included treatment as a fixed factor and basline Schiff score as a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favoured stannous fluoride toothpaste.|Null hypothesis is no difference between treatments. Tests were 2-sided.||0.06|-0.26|0.2294
91585759|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.6||0.409|TWO_SIDED|90.0|-1.13|0.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.86|-1.13|0.409
91647298|NCT01494649|183186381|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12||||0.1792||95.0|-0.3|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||0.06|-0.30|0.1792
91708787|NCT00808470|183310616|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||1 week after exposure||||.24
91708788|NCT01778751|183310624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.012|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Comparison at 3 months||-0.2|-1.7|0.012
91585760|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.61||0.482|TWO_SIDED|90.0|-1.03|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-1.03|0.482
91585761|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.5||0.592|TWO_SIDED|90.0|-0.71|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.71|0.592
91585762|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.5||0.368|TWO_SIDED|90.0|-1.0|0.66|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.66|-1.00|0.368
91585763|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.08||0.396|TWO_SIDED|90.0|-3.98|2.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.88|-3.98|0.396
91585764|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|2.09||0.545|TWO_SIDED|90.0|-3.21|3.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.69|-3.21|0.545
91585765|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.62||0.486|TWO_SIDED|90.0|-1.04|1.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.00|-1.04|0.486
91585766|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.63||0.324|TWO_SIDED|90.0|-1.33|0.75|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.75|-1.33|0.324
91585767|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.51||0.563|TWO_SIDED|90.0|-0.76|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.76|0.563
91708789|NCT01778751|183310624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.05|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||Comparison at 6 months||-0.0|-2.0|0.050
91585768|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.282|TWO_SIDED|90.0|-1.16|0.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.56|-1.16|0.282
91585769|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|2.12||0.409|TWO_SIDED|90.0|-3.99|3.01||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.01|-3.99|0.409
91585770|NCT00568321|183062566|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.293|TWO_SIDED|90.0|-4.76|2.39||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.39|-4.76|0.293
91585771|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.343|TWO_SIDED|90.0|-1.03|0.62|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.62|-1.03|0.343
91585772|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.576|TWO_SIDED|90.0|-0.75|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.75|0.576
91585773|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.63||0.46|TWO_SIDED|90.0|-1.1|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.10|0.460
91585774|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.15|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-1.15|0.435
91585775|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.104|TWO_SIDED|90.0|-1.62|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-1.62|0.104
91585776|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.57||0.204|TWO_SIDED|90.0|-1.42|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.42|0.204
91585777|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.5||0.931|TWO_SIDED|90.0|-0.08|1.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.58|-0.08|0.931
91585778|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.941|TWO_SIDED|90.0|-0.04|1.67|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.67|-0.04|0.941
91585779|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.63||0.936|TWO_SIDED|90.0|-0.08|2.01|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.01|-0.08|0.936
91585780|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.64||0.965|TWO_SIDED|90.0|0.11|2.23|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.23|0.11|0.965
91708790|NCT01778751|183310625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.303|TWO_SIDED|95.0|-2.7|8.4|||Mixed Models Analysis|||Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.||8.4|-2.7|0.303
91708791|NCT01778751|183310625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.7||||0.027|TWO_SIDED|95.0|0.9|14.4|||Mixed Models Analysis|||Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.||14.4|0.9|0.027
91585781|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.56||0.855|TWO_SIDED|90.0|-0.33|1.51|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.51|-0.33|0.855
91585782|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.58||0.765|TWO_SIDED|90.0|-0.54|1.38|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.38|-0.54|0.765
91585783|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.51||0.504|TWO_SIDED|90.0|-0.84|0.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.85|-0.84|0.504
91585784|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.643|TWO_SIDED|90.0|-0.67|1.06|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.06|-0.67|0.643
91585785|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.64||0.486|TWO_SIDED|90.0|-1.09|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-1.09|0.486
91585786|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.6|TWO_SIDED|90.0|-0.91|1.24|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.24|-0.91|0.600
91585787|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.57||0.418|TWO_SIDED|90.0|-1.05|0.82|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.82|-1.05|0.418
91585788|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.59||0.515|TWO_SIDED|90.0|-0.95|0.99|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.99|-0.95|0.515
91585789|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.53||0.456|TWO_SIDED|90.0|-0.93|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.93|0.456
91585790|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.54||0.556|TWO_SIDED|90.0|-0.82|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-0.82|0.556
91585791|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.67||0.448|TWO_SIDED|90.0|-1.19|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.19|0.448
91708792|NCT01778751|183310626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.83|TWO_SIDED|95.0|0.35|2.34|||Generalized estimating equation (GEE)|||||2.34|0.35|0.830
91585792|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.68||0.6|TWO_SIDED|90.0|-0.95|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.95|0.600
91585793|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.59||0.225|TWO_SIDED|90.0|-1.41|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-1.41|0.225
91585794|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.61||0.387|TWO_SIDED|90.0|-1.18|0.83|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.83|-1.18|0.387
91585795|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.54||0.657|TWO_SIDED|90.0|-0.67|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.67|0.657
91585796|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|90.0|-0.43|1.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.40|-0.43|0.808
91585797|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.68||0.742|TWO_SIDED|90.0|-0.68|1.57|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.57|-0.68|0.742
91585798|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.7||0.923|TWO_SIDED|90.0|-0.16|2.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.14|-0.16|0.923
91585799|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.6||0.49|TWO_SIDED|90.0|-1.01|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.01|0.490
91585800|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.609|TWO_SIDED|90.0|-0.86|1.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.20|-0.86|0.609
91585801|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.55||0.362|TWO_SIDED|90.0|-1.1|0.71|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.71|-1.10|0.362
91585802|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.56||0.61|TWO_SIDED|90.0|-0.77|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.77|0.610
91585803|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.7||0.376|TWO_SIDED|90.0|-1.37|0.93|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.93|-1.37|0.376
91585804|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.71||0.733|TWO_SIDED|90.0|-0.73|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.73|0.733
91585805|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.61||0.303|TWO_SIDED|90.0|-1.33|0.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.69|-1.33|0.303
91585806|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.63||0.548|TWO_SIDED|90.0|-0.97|1.12|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.12|-0.97|0.548
91585807|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.609|TWO_SIDED|90.0|-0.77|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-0.77|0.609
91585808|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.59||0.59|TWO_SIDED|90.0|-0.83|1.1|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.10|-0.83|0.590
91779331|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|27.5||||0.171|TWO_SIDED|95.0|-12.0|67.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.1|-12.0|0.1710
91779332|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0||||0.3362|TWO_SIDED|95.0|-106.7|36.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.7|-106.7|0.3362
91779333|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|126.9||||0.0006|TWO_SIDED|95.0|55.2|198.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.5|55.2|0.0006
91779334|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|53.2||||0.1449|TWO_SIDED|95.0|-18.5|124.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.8|-18.5|0.1449
91779335|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|38.7||||0.2882|TWO_SIDED|95.0|-33.0|110.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||110.4|-33.0|0.2882
91779336|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|55.0||||0.1314|TWO_SIDED|95.0|-16.6|126.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||126.7|-16.6|0.1314
91779337|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1||||0.5808|TWO_SIDED|95.0|-51.6|91.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||91.8|-51.6|0.5808
91779338|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.2||||0.1415|TWO_SIDED|95.0|-154.6|22.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.3|-154.6|0.1415
91779339|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|149.1||||0.0011|TWO_SIDED|95.0|60.7|237.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||237.5|60.7|0.0011
91779340|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|52.5||||0.2423|TWO_SIDED|95.0|-35.9|140.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||140.9|-35.9|0.2423
91585809|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.71||0.556|TWO_SIDED|90.0|-1.07|1.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.27|-1.07|0.556
91585810|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.73||0.443|TWO_SIDED|90.0|-1.32|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-1.32|0.443
91708793|NCT01778751|183310626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.97|TWO_SIDED|95.0|0.33|3.19|||Generalized Estimating Equation (GEE)|||Comparison at 6 months||3.19|0.33|0.970
91779341|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4||||0.498|TWO_SIDED|95.0|-58.0|118.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.8|-58.0|0.4980
91779342|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|54.5||||0.2253|TWO_SIDED|95.0|-33.9|142.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.9|-33.9|0.2253
91779343|NCT01746901|183439324|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.7945|TWO_SIDED|95.0|-76.8|100.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|-76.8|0.7945
91779344|NCT01746901|183439325|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.0129|TWO_SIDED|95.0|-5.1|-0.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.6|-5.1|0.0129
91779345|NCT01746901|183439325|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0003|TWO_SIDED|95.0|2.0|6.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.5|2.0|0.0003
91779346|NCT01746901|183439325|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5483|TWO_SIDED|95.0|-1.6|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.6|0.5483
91779347|NCT01746901|183439325|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5284|TWO_SIDED|95.0|-1.5|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.5|0.5284
91779348|NCT01746901|183439325|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1331|TWO_SIDED|95.0|-0.5|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-0.5|0.1331
91779349|NCT01746901|183439325|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.8732|TWO_SIDED|95.0|-2.1|2.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.4|-2.1|0.8732
91585811|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.62||0.527|TWO_SIDED|90.0|-0.99|1.07|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.07|-0.99|0.527
91585812|NCT00568321|183062573|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.66||0.583|TWO_SIDED|90.0|-0.95|1.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.22|-0.95|0.583
91585813|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.63||0.111|TWO_SIDED|90.0|-1.81|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.81|0.111
91779350|NCT01746901|183439326|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4555|TWO_SIDED|95.0|-5.9|13.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-5.9|0.4555
91779351|NCT01746901|183439326|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.1495|TWO_SIDED|95.0|-2.5|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-2.5|0.1495
91779352|NCT01746901|183439326|SUPERIORITY_OR_OTHER||LS Mean Difference|11.4||||0.02|TWO_SIDED|95.0|1.8|20.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|1.8|0.0200
91779353|NCT01746901|183439326|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.8668|TWO_SIDED|95.0|-10.3|8.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.7|-10.3|0.8668
91779354|NCT01746901|183439326|SUPERIORITY_OR_OTHER||LS Mean Difference|4.1||||0.3904|TWO_SIDED|95.0|-5.3|13.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.6|-5.3|0.3904
91779355|NCT01746901|183439326|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6524|TWO_SIDED|95.0|-7.3|11.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|-7.3|0.6524
91779356|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1771|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1771
91779357|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.3944|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3944
91779358|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1778|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1778
91779359|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.396|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3960
91521202|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1979|TWO_SIDED|95.0|-0.8|0.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.2|-0.8|0.1979
91779360|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.6125|TWO_SIDED|95.0|-0.9|1.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-0.9|0.6125
91779361|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.9059|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.1|0.9059
91779362|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.4585|TWO_SIDED|95.0|-2.9|6.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|-2.9|0.4585
91779363|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8986|TWO_SIDED|95.0|-4.2|4.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.8|-4.2|0.8986
91779364|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.3641|TWO_SIDED|95.0|-2.5|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.5|0.3641
91779365|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9674|TWO_SIDED|95.0|-4.6|4.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|-4.6|0.9674
91585814|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.64||0.523|TWO_SIDED|90.0|-1.02|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.02|0.523
91585815|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.63||0.887|TWO_SIDED|90.0|-0.28|1.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.81|-0.28|0.887
91585816|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.65||0.903|TWO_SIDED|90.0|-0.23|1.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.92|-0.23|0.903
91585817|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.64||0.472|TWO_SIDED|90.0|-1.11|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.11|0.472
91585818|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.66||0.628|TWO_SIDED|90.0|-0.87|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.87|0.628
91585819|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.67||0.243|TWO_SIDED|90.0|-1.58|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-1.58|0.243
91585820|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.69||0.346|TWO_SIDED|90.0|-1.42|0.87|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.87|-1.42|0.346
91585821|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.69||0.467|TWO_SIDED|90.0|-1.19|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-1.19|0.467
91585822|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.7||0.67|TWO_SIDED|90.0|-0.85|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.85|0.670
91585823|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.286|TWO_SIDED|90.0|-1.55|0.76|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.76|-1.55|0.286
91585824|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.71||0.598|TWO_SIDED|90.0|-1.0|1.35|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.35|-1.00|0.598
91585825|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.453|TWO_SIDED|90.0|-1.26|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.26|0.453
91521203|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1079|TWO_SIDED|95.0|-0.8|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.1|-0.8|0.1079
91585826|NCT00568321|183062576|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|90.0|-1.28|1.17|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.17|-1.28|0.472
91585827|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.02||0.548|TWO_SIDED|90.0|-1.81|1.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.56|-1.81|0.548
91585828|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.04||0.117|TWO_SIDED|90.0|-0.48|2.96|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.96|-0.48|0.117
91779366|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.5744|TWO_SIDED|95.0|-3.2|5.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-3.2|0.5744
91585829|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.11||0.779|TWO_SIDED|90.0|-2.69|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-2.69|0.779
91779367|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.3457|TWO_SIDED|95.0|-2.4|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.4|0.3457
91779368|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.6664|TWO_SIDED|95.0|-13.3|20.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.8|-13.3|0.6664
91779369|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.1949|TWO_SIDED|95.0|-5.8|28.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.0|-5.8|0.1949
91779370|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.2009|TWO_SIDED|95.0|-6.0|28.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|-6.0|0.2009
91779371|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8||||0.6595|TWO_SIDED|95.0|-13.1|20.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.7|-13.1|0.6595
91585830|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|1.14||0.375|TWO_SIDED|90.0|-1.52|2.25|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.25|-1.52|0.375
91585831|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.15||0.881|TWO_SIDED|90.0|-3.26|0.54|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.54|-3.26|0.881
91585832|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.17||0.636|TWO_SIDED|90.0|-2.33|1.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.52|-2.33|0.636
91585833|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.17||0.905|TWO_SIDED|90.0|-3.46|0.39|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.39|-3.46|0.905
91708794|NCT01778751|183310627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.428|TWO_SIDED|95.0|-3.3|1.4|||Mixed Models Analysis|||Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||1.4|-3.3|0.428
91779372|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.3176|TWO_SIDED|95.0|-8.3|25.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|-8.3|0.3176
91779373|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.6423|TWO_SIDED|95.0|-12.9|20.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|-12.9|0.6423
91779374|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4358|TWO_SIDED|95.0|-10.5|24.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.2|-10.5|0.4358
91779375|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.1789|TWO_SIDED|95.0|-5.4|28.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|-5.4|0.1789
91585834|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.21||0.499|TWO_SIDED|90.0|-2.0|2.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.00|-2.00|0.499
91585835|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.5||0.297|TWO_SIDED|90.0|-0.56|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.56|0.297
91585836|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.5||0.035|TWO_SIDED|90.0|0.09|1.74|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.74|0.09|0.035
91647299|NCT01494649|183186382|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||-0.30|-0.74|<0.0001
91647300|NCT01494649|183186383|SUPERIORITY_OR_OTHER||Mean adjusted difference|-0.08||||0.9445|TWO_SIDED|95.0|-2.49|2.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Tactile Threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2.32|-2.49|0.9445
91708795|NCT01778751|183310627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.397|TWO_SIDED|95.0|-1.4|3.6|||Mixed Models Analysis|||Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||3.6|-1.4|0.397
91708796|NCT01945294|183310652|SUPERIORITY_OR_OTHER||Difference in SVR12 percentage|-11.4|||||TWO_SIDED|95.0|-23.2|0.4||||||||0.4|-23.2|
91708797|NCT03403621|183310718|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.42
91708798|NCT03403621|183310718|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.72
91708799|NCT03403621|183310718|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.51
91708800|NCT03403621|183310718|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.58
91708801|NCT03403621|183310719|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.03
91585837|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.54||0.222|TWO_SIDED|90.0|-0.48|1.31|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.31|-0.48|0.222
91585838|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.54||0.069|TWO_SIDED|90.0|-0.09|1.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.70|-0.09|0.069
91585839|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.55||0.338|TWO_SIDED|90.0|-0.68|1.15|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.15|-0.68|0.338
91585840|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.56||0.381|TWO_SIDED|90.0|-0.75|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.75|0.381
91585841|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.56||0.306|TWO_SIDED|90.0|-0.64|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.64|0.306
91708802|NCT03403621|183310719|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.08
91585842|NCT00568321|183062590|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.58||0.44|TWO_SIDED|90.0|-0.87|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.87|0.440
91585843|NCT02175004|183062621|SUPERIORITY||Least Squares Mean Difference|-17.84|||<|0.001|TWO_SIDED|95.0|-26.12|-9.56||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 78||-9.56|-26.12|<0.001
91585844|NCT02175004|183062621|SUPERIORITY||Least Squares Mean Difference|-20.11|||<|0.001|TWO_SIDED|95.0|-31.27|-8.95||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 156||-8.95|-31.27|<0.001
91585845|NCT02175004|183062622|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.638|TWO_SIDED|95.0|-0.32|0.2||P-value=MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 78||0.20|-0.32|0.638
91708803|NCT03403621|183310719|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.02
91708804|NCT03403621|183310719|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.007
91521204|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5805|TWO_SIDED|95.0|-0.6|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.3|-0.6|0.5805
91708805|NCT03403621|183310720|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.21
91708806|NCT03403621|183310720|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.18
91708807|NCT03403621|183310720|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.33
91708808|NCT03403621|183310720|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.5
91585846|NCT02175004|183062622|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.965|TWO_SIDED|95.0|-0.3|0.29||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 156||0.29|-0.30|0.965
91585847|NCT02175004|183062623|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.68|-0.5||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 78||-0.50|-1.68|<0.001
91585848|NCT02175004|183062623|SUPERIORITY||Least Squares Mean Difference|-0.66||||0.067|TWO_SIDED|95.0|-1.38|0.05||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 156||0.05|-1.38|0.067
91521205|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.8057|TWO_SIDED|95.0|-0.4|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.5|-0.4|0.8057
91585849|NCT02175004|183062624|SUPERIORITY||Least Squares Mean Difference|0.34||||0.821|TWO_SIDED|95.0|-2.67|3.36||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 78||3.36|-2.67|0.821
91585850|NCT02175004|183062624|SUPERIORITY||Least Squares Mean Difference|-2.16||||0.293|TWO_SIDED|95.0|-6.21|1.9||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 156||1.90|-6.21|0.293
91585851|NCT02175004|183062625|SUPERIORITY||Least Squares Mean Difference|-2.78||||0.047|TWO_SIDED|95.0|-5.53|-0.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 78||-0.03|-5.53|0.047
91585852|NCT02175004|183062625|SUPERIORITY||Least Squares Mean Difference|-3.07||||0.041|TWO_SIDED|95.0|-6.0|-0.13||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 156||-0.13|-6.00|0.041
91585853|NCT02175004|183062626|OTHER||Least Squares Mean Difference|-17.48|||<|0.001|TWO_SIDED|95.0|-26.92|-8.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the NIS Composite Score at Week 52 of Year 4||-8.03|-26.92|<0.001
91585854|NCT02175004|183062627|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.941|TWO_SIDED|95.0|-0.19|0.17||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Cranial Nerves Score Score at Week 52 of Year 4||0.17|-0.19|0.941
91585855|NCT02175004|183062628|SUPERIORITY||Least Squares Mean Difference|-9.56||||0.011|TWO_SIDED|95.0|-16.97|-2.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Muscle Weakness Score at Week 52 of Years 4||-2.16|-16.97|0.011
91647301|NCT01494649|183186384|SUPERIORITY_OR_OTHER||Adjusted mean|-2.07||||0.22|TWO_SIDED|95.0|-5.38|1.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||1.25|-5.38|0.220
91521206|NCT02954354|182917039|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9525|TWO_SIDED|95.0|-0.6|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.6|0.9525
91585856|NCT02175004|183062629|SUPERIORITY||Least Squares Mean Difference|-1.05||||0.356|TWO_SIDED|95.0|-3.28|1.18||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Reflexes Score at Week 52 of Years 4||1.18|-3.28|0.356
91585857|NCT02175004|183062630|SUPERIORITY||Least Squares Mean Difference|-5.38|||<|0.001|TWO_SIDED|95.0|-8.58|-2.19||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Sensory Score at Week 52 of Years 4||-2.19|-8.58|<0.001
91585858|NCT02175004|183062631|SUPERIORITY||Least Squares Mean Difference|-9.31||||0.026|TWO_SIDED|95.0|-17.48|-1.14||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||-1.14|-17.48|0.026
91585859|NCT02175004|183062631|SUPERIORITY||Least Squares Mean Difference|-7.4||||0.107|TWO_SIDED|95.0|-16.41|1.62||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 156||1.62|-16.41|0.107
91585860|NCT02175004|183062631|SUPERIORITY||Least Squares Mean Difference|-2.72||||0.669|TWO_SIDED|95.0|-15.22|9.77||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 52 of Year 4||9.77|-15.22|0.669
91647302|NCT01494649|183186385|SUPERIORITY_OR_OTHER||Mean adjusted difference|8.69||||0.0004|TWO_SIDED|95.0|3.96|13.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||13.43|3.96|0.0004
91647303|NCT02508649|183186453|SUPERIORITY||Treatment difference|0.55||||0.3015|TWO_SIDED|95.0|-1.34|2.43|||van Elteren test|||The primary endpoint was analyzed using a van Elteren test. The analysis included a test of superiority using a two-sided 5% significance level.||2.43|-1.34|0.3015
91585861|NCT02175004|183062632|SUPERIORITY||Least Squares Mean Difference|-6.3||||0.097|TWO_SIDED|95.0|-13.75|1.15||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Change From CS2 Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||1.15|-13.75|0.097
91585862|NCT02175004|183062632|SUPERIORITY||Least Squares Mean Difference|-8.89||||0.081|TWO_SIDED|95.0|-18.88|1.11||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the Norfolk QoL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 156||1.11|-18.88|0.081
91585863|NCT02175004|183062632|SUPERIORITY||Least Squares Mean Difference|-11.87||||0.171|TWO_SIDED|95.0|-28.89|5.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 52 of Year 4||5.16|-28.89|0.171
91585864|NCT00343252|183062720|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.||||0.642
91585865|NCT00343252|183062721|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.||||0.683
91585866|NCT00343252|183062722|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.||||0.809
91647304|NCT02508649|183186454|SUPERIORITY||Odds Ratio (OR)|1.049||||0.7694|TWO_SIDED|95.0|0.762|1.445|||Regression, Logistic||An odds ratio \< 1 in proportion of subjects dying indicates lower mortality in the selepressin group.|Mortality was analyzed using a logistic regression model with the individual sequential organ failure assessment (SOFA) scores and age as covariates and treatment arm as factor.||1.445|0.762|0.7694
91708809|NCT01738191|183310750|SUPERIORITY|||||||0.25||||||two sided|Global Statistical Test|df=28||The primary comparison between ATM and placebo used O'Brien's Global Statistical Test (GST) to analyze change from baseline to 10 weeks for the set of neuropsychological measures included in the primary efficacy outcome.||||0.25
91585867|NCT00343252|183062723|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.||||0.986
91585868|NCT00343252|183062724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.746|TWO_SIDED|95.0|0.85|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 6-month endpoint.||1.26|0.85|0.746
91585869|NCT00343252|183062725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.719|TWO_SIDED|95.0|0.86|1.25||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 12-month endpoint.||1.25|0.86|0.719
91585870|NCT00343252|183062726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.681|TWO_SIDED|95.0|0.86|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction for average back pain at the 6-month endpoint.||1.26|0.86|0.681
91647305|NCT02508649|183186455|SUPERIORITY||Treatment difference|0.29||||0.8458|TWO_SIDED|95.0|-2.07|2.65|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.65|-2.07|0.8458
91647306|NCT02508649|183186456|SUPERIORITY||Treatment difference|0.49||||0.4124|TWO_SIDED|95.0|-1.22|2.19|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.19|-1.22|0.4124
91647307|NCT02508649|183186463|OTHER||Treatment difference|-0.51||||0.2009|TWO_SIDED|95.0|-1.3|0.27|||ANCOVA|||Overall score using a modified version of the SOFA on Day 1||0.27|-1.30|0.2009
91708810|NCT01451554|183310762|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||2 tailed t-test|t-test, 2 sided|||Data were compared between groups using the 2 sample T-test.||||0.06
91708811|NCT01451554|183310763|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Data were compared between groups using a 2 sample T-test.||||0.31
91585871|NCT00343252|183062727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.789|TWO_SIDED|95.0|0.86|1.23||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in average back pain at the 12-month endpoint.||1.23|0.86|0.789
91585872|NCT00343252|183062728|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.||||0.968
91585873|NCT00343252|183062729|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.||||0.568
91585874|NCT00343252|183062730|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.||||0.932
91585875|NCT00343252|183062731|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.||||0.814
91585876|NCT00343252|183062732|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.||||0.572
91585877|NCT00343252|183062735|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.600
91585878|NCT00343252|183062736|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.399
91708812|NCT02576977|183310776|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.99324|TWO_SIDED|95.0|1.08|2.08|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|||2.08|1.08|0.99324
91585879|NCT00343252|183062737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.453|TWO_SIDED|95.0|0.89|1.28|||Log Rank|||||1.28|0.89|0.453
91585880|NCT00343252|183062738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.353|TWO_SIDED|95.0|0.91|1.3|||Log Rank|||||1.30|0.91|0.353
91585881|NCT00343252|183062739|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||ANCOVA|||||||0.943
91585882|NCT00343252|183062740|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANCOVA|||||||0.553
91585883|NCT01592864|183062744|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.2|-0.6|<0.0001
91521207|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4091|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.8|-0.3|0.4091
91585884|NCT01592864|183062745|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.3|-0.6|<0.0001
91585885|NCT01592864|183062746|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.9|||<|0.0001|TWO_SIDED|95.0|11.1|22.8||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||22.8|11.1|<0.0001
91585886|NCT01592864|183062747|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.4|13.9||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favors first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||13.9|5.4|<0.0001
91585887|NCT01519466|183062766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_DEVIATION|2.32||0.0926|TWO_SIDED|95.0|-1.55|0.12|||t-test, 2 sided|||||0.12|-1.55|0.0926
91585888|NCT01519466|183062766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_DEVIATION|2.97||||||||||||||||
91585889|NCT01519466|183062767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.49||0.3251|TWO_SIDED|95.0|-0.27|0.09|||t-test, 2 sided|||||0.09|-0.27|0.3251
91585890|NCT01519466|183062767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.51||||||||||||||||
91647308|NCT02508649|183186463|OTHER||Treatment difference|0.11||||0.7894|TWO_SIDED|95.0|-0.68|0.9|||ANCOVA|||Overall score using a modified version of the SOFA on Day 3||0.90|-0.68|0.7894
91708813|NCT02576977|183310777|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.99989|TWO_SIDED|95.0|1.32|2.55|||Log Rank|One-sided p-value based on Stratified log-rank test.|||The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|2.55|1.32|0.99989
91585891|NCT01519466|183062768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.26||0.5798|TWO_SIDED|95.0|-0.33|0.58|||t-test, 2 sided|||Hyperglycaemia, glucose above 10mmol/l (180mg/dL)||0.58|-0.33|0.5798
91585892|NCT01519466|183062768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_DEVIATION|1.03||0.096|TWO_SIDED|95.0|-0.68|0.06|||t-test, 2 sided|||Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)||0.06|-0.68|0.0960
91585893|NCT01519466|183062768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_DEVIATION|6.53||0.0007|TWO_SIDED|95.0|2.01|6.71|||t-test, 2 sided|||Treatment Satisfaction||6.71|2.01|0.0007
91585894|NCT00307125|183062771|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||Analysis by Fisher's exact test counting participants with 50% decrease in anti-HLA antibodies at any time within 12 months post treatment initiation||||>0.999
91585895|NCT00307125|183062776|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
91585896|NCT00307125|183062777|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
91585897|NCT03552822|183062780|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91585898|NCT03552822|183062781|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
91585899|NCT03552822|183062782|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91585900|NCT03552822|183062783|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91585901|NCT03552822|183062784|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
91647309|NCT02508649|183186463|OTHER||Treatment difference|0.55||||0.1888|TWO_SIDED|95.0|-0.27|1.37|||ANCOVA|||Overall score using a modified version of the SOFA on Day 7||1.37|-0.27|0.1888
91647310|NCT02508649|183186463|OTHER||Treatment difference|-0.08||||0.2997|TWO_SIDED|95.0|-0.24|0.07|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 1||0.07|-0.24|0.2997
91647311|NCT02508649|183186463|OTHER||Treatment difference|-0.03||||0.6796|TWO_SIDED|95.0|-0.19|0.12|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 3||0.12|-0.19|0.6796
91647312|NCT02508649|183186463|OTHER||Treatment difference|0.03||||0.7467|TWO_SIDED|95.0|-0.14|0.19|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 7||0.19|-0.14|0.7467
91585902|NCT03552822|183062785|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
91585903|NCT03552822|183062786|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91585904|NCT03552822|183062787|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91585905|NCT03552822|183062788|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
91585906|NCT00561951|183062805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.002||95.0|-0.56|-0.13||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.13|-0.56|0.002
91585907|NCT00561951|183062805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.6|-0.17||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.17|-0.60|<0.001
91647313|NCT02508649|183186463|OTHER||Treatment difference|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 1||-0.19|-0.65|0.0003
91779376|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|14.0||||0.1131|TWO_SIDED|95.0|-3.3|31.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.3|-3.3|0.1131
91585908|NCT00561951|183062807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002||95.0|-0.91|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-0.91|0.002
91585909|NCT00561951|183062807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||<|0.001||95.0|-1.01|-0.32|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.32|-1.01|<0.001
91585910|NCT00561951|183062809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.003||95.0|-1.07|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-1.07|0.003
91585911|NCT00561951|183062809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.002||95.0|-1.09|-0.23|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.23|-1.09|0.002
91585912|NCT00561951|183062811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002||95.0|-0.63|-0.14|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.14|-0.63|0.002
91585913|NCT00561951|183062811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.03||95.0|-0.52|-0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.03|-0.52|0.030
91585914|NCT00561951|183062813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.624||95.0|-0.18|0.11|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.11|-0.18|0.624
91585915|NCT00561951|183062813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.129||95.0|-0.26|0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.03|-0.26|0.129
91585916|NCT02254278|183062851|SUPERIORITY|||||||0.04|||||||binomial|One-sided significance level=0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.04
91585917|NCT02254278|183062851|SUPERIORITY|||||||0.23|||||||bionmial|One-sided significance level = 0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.23
91585918|NCT02254278|183062852|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.02|TWO_SIDED|95.0|0.17|0.9|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||0.90|0.17|0.02
91585919|NCT02254278|183062853|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.58|TWO_SIDED|95.0|0.4|5.08|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||5.08|0.4|0.58
91585920|NCT02254278|183062854|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.93|TWO_SIDED|95.0|0.31|2.95||Two-side significance level = 0.05|Log Rank||Reference level = IMRT 5 weeks|||2.95|0.31|0.93
91585921|NCT02254278|183062855|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|Two-sided significance level = 0.05||End of RT||||<0.0001
91585922|NCT02254278|183062855|SUPERIORITY|||||||0.17|||||||Fisher Exact|Two-sided significance level = 0.05||One month after end of RT||||0.17
91647314|NCT02508649|183186463|OTHER||Treatment difference|-0.25||||0.0349|TWO_SIDED|95.0|-0.49|-0.02|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 3||-0.02|-0.49|0.0349
91647315|NCT02508649|183186463|OTHER||Treatment difference|-0.14||||0.2787|TWO_SIDED|95.0|-0.39|0.11|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 7||0.11|-0.39|0.2787
91647316|NCT02508649|183186463|OTHER||Treatment difference|-0.05||||0.6476|TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 1||0.16|-0.26|0.6476
91647317|NCT02508649|183186463|OTHER||Treatment difference|0.08||||0.4313|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 3||0.29|-0.13|0.4313
91647318|NCT02508649|183186463|OTHER||Treatment difference|0.17||||0.1334|TWO_SIDED|95.0|-0.05|0.39|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 7||0.39|-0.05|0.1334
91585923|NCT02254278|183062855|SUPERIORITY|||||||0.16|||||||Fisher Exact|Two-side significance level = 0.05||Six months after end of RT||||0.16
91585924|NCT02254278|183062855|SUPERIORITY|||||||0.26|||||||Fisher Exact|Two-side significance level = 0.05||One year after end of RT||||0.26
91585925|NCT02254278|183062855|SUPERIORITY|||||||0.82|||||||Fisher Exact|Two-side significance level = 0.05||Two years after the end of RT||||0.82
91585926|NCT02254278|183062857|SUPERIORITY|||||||0.3|||||||binomial test|One-sided significance level = 0.10||Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.3
91585927|NCT02254278|183062857|SUPERIORITY|||||||0.07|||||||binomial test|One-sided significance level = 0.10||Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.07
91585928|NCT02254278|183062858|SUPERIORITY|||||||0.28|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.28
91585929|NCT02254278|183062859|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.03
91585930|NCT02254278|183062863|SUPERIORITY|||||||0.08|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.08
91585931|NCT02254278|183062864|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.02
91585932|NCT06729593|183062865|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.45|2.11||Proportional odds model stratified by disease severity (high flow nasal canula(HFNC)/non-invasive ventilation(NIV) or invasive mechanical ventiliation(IMV)/ECMO) at study entry to determine the odds of being in a better category at day 90.|Proportional odds model||Summary odds ratio for being in a better category, active/placebo (95% confidence interval); pvalue|||2.11|0.45|0.96
91585933|NCT06729593|183062866|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.37|TWO_SIDED|95.0|0.39|1.42|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.42|0.39|0.37
91585934|NCT06729593|183062867|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8|TWO_SIDED|95.0|0.37|2.14|||Regression, Logistic||Odds ratio for active/placebo (95% confidence interval); pvalue|||2.14|0.37|0.80
91585935|NCT06729593|183062868|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.88|TWO_SIDED|95.0|0.64|1.67|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.67|0.64|0.88
91585936|NCT06729593|183062869|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5|TWO_SIDED|95.0|0.43|1.5|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.50|0.43|0.50
91647319|NCT02508649|183186463|OTHER||Treatment difference|0.12||||0.2126|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 1||0.30|-0.07|0.2126
91779377|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.5965|TWO_SIDED|95.0|-12.6|21.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.8|-12.6|0.5965
91585937|NCT05437510|183062870|SUPERIORITY||Efficacy|84.04|||<|0.0001|TWO_SIDED|95.0|69.493|92.411|||Exact method using binomial distribution|||The 2-sided 95% confidence interval (CI) for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||92.411|69.493|<0.0001
91585938|NCT05437510|183062871|SUPERIORITY||Efficacy|77.71||||0.0014|TWO_SIDED|95.0|39.249|93.432|||Exact method using binomial distribution|||The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||93.432|39.249|0.0014
91585939|NCT05437510|183062872|SUPERIORITY||Efficacy|90.7|||<|0.0001|TWO_SIDED|95.0|63.676|98.813||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for France: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||98.813|63.676|<0.0001
91585940|NCT05437510|183062872|SUPERIORITY||Efficacy|83.2||||0.0036|TWO_SIDED|95.0|33.589|97.593||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for UK: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||97.593|33.589|0.0036
91647320|NCT02508649|183186463|OTHER||Treatment Difference|0.23||||0.0174|TWO_SIDED|95.0|0.04|0.41|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 3||0.41|0.04|0.0174
91647321|NCT02508649|183186463|OTHER||Treatment difference|0.23||||0.0194|TWO_SIDED|95.0|0.04|0.43|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 7||0.43|0.04|0.0194
91647322|NCT02508649|183186463|OTHER||Treatment difference|-0.15||||0.1284|TWO_SIDED|95.0|-0.35|0.04|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 1||0.04|-0.35|0.1284
91779378|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.3175|TWO_SIDED|95.0|-8.5|25.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.9|-8.5|0.3175
91779379|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.6551|TWO_SIDED|95.0|-13.3|21.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.0|-13.3|0.6551
91779380|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3||||0.0354|TWO_SIDED|95.0|-87.5|-3.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.1|-87.5|0.0354
91779381|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|55.2||||0.01|TWO_SIDED|95.0|13.4|97.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.0|13.4|0.0100
91708814|NCT02576977|183310778|SUPERIORITY||Difference in % vs. SOC|-5.2||||0.79921|TWO_SIDED|95.0|-17.1|6.9|||Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|6.9|-17.1|0.79921
91647323|NCT02508649|183186463|OTHER||Treatment difference|-0.05||||0.6542|TWO_SIDED|95.0|-0.25|0.15|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 3||0.15|-0.25|0.6542
91585941|NCT05437510|183062872|SUPERIORITY||Efficacy|74.62||||0.0051|TWO_SIDED|95.0|29.74|92.595||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for Germany: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||92.595|29.740|0.0051
91585942|NCT05437510|183062873|SUPERIORITY||Efficacy|57.97|||<|0.0001|TWO_SIDED|95.0|40.36|70.76|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||70.760|40.360|<0.0001
91585943|NCT05437510|183062873|SUPERIORITY||Efficacy|52.48||||0.0039|TWO_SIDED|95.0|20.121|72.36|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||72.360|20.121|0.0039
91585944|NCT05437510|183062873|SUPERIORITY||Efficacy|58.62||||0.0024|TWO_SIDED|95.0|25.115|78.049|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||78.049|25.115|0.0024
91585945|NCT05437510|183062873|SUPERIORITY||Efficacy|70.74||||0.0037|TWO_SIDED|95.0|29.567|89.396|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.396|29.567|0.0037
91585946|NCT05437510|183062874|SUPERIORITY||Efficacy|82.44|||<|0.0001|TWO_SIDED|95.0|67.271|91.357|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.357|67.271|<0.0001
91585947|NCT05437510|183062874|SUPERIORITY||Efficacy|86.11|||<|0.0001|TWO_SIDED|95.0|60.283|96.459|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.459|60.283|<0.0001
91647324|NCT02508649|183186463|OTHER||Treatment difference|0.17||||0.1079|TWO_SIDED|95.0|-0.04|0.38|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 7||0.38|-0.04|0.1079
91585948|NCT05437510|183062874|SUPERIORITY||Efficacy|85.2||||0.0004|TWO_SIDED|95.0|50.084|97.183|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.183|50.084|0.0004
91585949|NCT05437510|183062874|SUPERIORITY||Efficacy|74.36||||0.0055|TWO_SIDED|95.0|29.006|92.518|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.518|29.006|0.0055
91779382|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.5379|TWO_SIDED|95.0|-29.0|55.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.4|-29.0|0.5379
91779383|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3||||0.8768|TWO_SIDED|95.0|-45.1|38.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-45.1|0.8768
91779384|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.7031|TWO_SIDED|95.0|-33.8|49.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.9|-33.8|0.7031
91779385|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.8507|TWO_SIDED|95.0|-45.8|37.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|-45.8|0.8507
91585950|NCT05437510|183062875|SUPERIORITY||Efficacy|75.31||||0.0013|TWO_SIDED|95.0|38.012|91.747|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.747|38.012|0.0013
91585951|NCT05437510|183062875|SUPERIORITY||Efficacy|78.1||||0.062|TWO_SIDED|95.0|-5.823|97.697|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.697|-5.823|0.0620
91779386|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.3||||0.0381|TWO_SIDED|95.0|-121.2|-3.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.5|-121.2|0.0381
91779387|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|64.0||||0.0318|TWO_SIDED|95.0|5.7|122.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||122.3|5.7|0.0318
91779388|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|15.2||||0.6095|TWO_SIDED|95.0|-43.6|74.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.1|-43.6|0.6095
91779389|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.6||||0.647|TWO_SIDED|95.0|-71.9|44.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.8|-71.9|0.6470
91779390|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.8136|TWO_SIDED|95.0|-51.4|65.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.4|-51.4|0.8136
91779391|NCT01746901|183439327|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.6||||0.6699|TWO_SIDED|95.0|-71.0|45.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.7|-71.0|0.6699
91779392|NCT01746901|183439328|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1728|TWO_SIDED|95.0|-3.9|0.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-3.9|0.1728
91779393|NCT01746901|183439328|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.2616|TWO_SIDED|95.0|-1.0|3.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.6|-1.0|0.2616
91779394|NCT01746901|183439328|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7307|TWO_SIDED|95.0|-1.9|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-1.9|0.7307
91779395|NCT01746901|183439328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5473|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5473
91779396|NCT01746901|183439328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.4999|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.1|0.4999
91779397|NCT01746901|183439328|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5592|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5592
91779398|NCT01746901|183439329|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0217|TWO_SIDED|95.0|2.0|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|2.0|0.0217
91585952|NCT05437510|183062875|SUPERIORITY||Efficacy|91.01||||0.006|TWO_SIDED|95.0|38.156|99.791|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||99.791|38.156|0.0060
91585953|NCT05437510|183062875|SUPERIORITY||Efficacy|26.01||||0.9851|TWO_SIDED|95.0|-337.329|89.162|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.162|-337.329|0.9851
91647325|NCT02508649|183186464|OTHER||Odds Ratio (OR)|1.4||||0.063|TWO_SIDED|95.0|0.98|2.0|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 7||2.00|0.98|0.0630
91647326|NCT02508649|183186464|OTHER||Odds Ratio (OR)|1.28||||0.1875|TWO_SIDED|95.0|0.89|1.86|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 30||1.86|0.89|0.1875
91710801|NCT02258217|183314013|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse) This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|3.09||0.99|TWO_SIDED|95.0|-1.22|1.22|||Paired t-test, 2 sided|||"We compared the two RSH scores measured in the same arm at different time points (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post RSH scores."||1.22|-1.22|0.99
91647327|NCT02508649|183186464|OTHER||Odds Ratio (OR)|1.14||||0.4382|TWO_SIDED|95.0|0.82|1.58|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 7||1.58|0.82|0.4382
91647328|NCT02508649|183186464|OTHER||Odds Ratio (OR)|1.01||||0.9529|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 30||1.39|0.73|0.9529
91647329|NCT00446134|183186473|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Other|12.75|STANDARD_DEVIATION|5.0||0.167|TWO_SIDED|95.0|-3.65|29.15|||Fisher Exact|||||29.15|-3.65|0.167
91585954|NCT05437510|183062876|SUPERIORITY||Efficacy|43.62|||<|0.0001|TWO_SIDED|95.0|24.677|58.057|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||58.057|24.677|<0.0001
91779399|NCT01746901|183439329|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.5513|TWO_SIDED|95.0|-7.8|14.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.6|-7.8|0.5513
91779400|NCT01746901|183439329|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0469|TWO_SIDED|95.0|0.2|22.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.8|0.2|0.0469
91779401|NCT01746901|183439329|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.3604|TWO_SIDED|95.0|-6.0|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-6.0|0.3604
91779402|NCT01746901|183439329|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2||||0.2725|TWO_SIDED|95.0|-5.0|17.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|-5.0|0.2725
91779403|NCT01746901|183439329|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4||||0.3461|TWO_SIDED|95.0|-5.8|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-5.8|0.3461
91779404|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1828|TWO_SIDED|95.0|-1.1|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-1.1|0.1828
91779405|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5||||0.3908|TWO_SIDED|95.0|-5.0|1.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.9|-5.0|0.3908
91779406|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.2513|TWO_SIDED|95.0|-1.5|5.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.5|-1.5|0.2513
91779407|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.5035|TWO_SIDED|95.0|-4.6|2.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-4.6|0.5035
91779408|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.1452|TWO_SIDED|95.0|-0.9|6.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.0|-0.9|0.1452
91779409|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.9303|TWO_SIDED|95.0|-3.6|3.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-3.6|0.9303
91779410|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8||||0.0283|TWO_SIDED|95.0|0.9|16.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.7|0.9|0.0283
91585955|NCT05437510|183062876|SUPERIORITY||Efficacy|34.78||||0.0754|TWO_SIDED|95.0|-4.148|59.648|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||59.648|-4.148|0.0754
91585956|NCT05437510|183062876|SUPERIORITY||Efficacy|40.67||||0.0177|TWO_SIDED|95.0|8.211|62.156|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||62.156|8.211|0.0177
91585957|NCT05437510|183062876|SUPERIORITY||Efficacy|66.38||||0.0046|TWO_SIDED|95.0|25.952|86.137|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||86.137|25.952|0.0046
91585958|NCT05437510|183062881|SUPERIORITY||Efficacy|82.72|||<|0.0001|TWO_SIDED|95.0|67.826|91.49|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.490|67.826|<0.0001
91585959|NCT05437510|183062881|SUPERIORITY||Efficacy|86.13|||<|0.0001|TWO_SIDED|95.0|60.34|96.464|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.464|60.340|<0.0001
91585960|NCT05437510|183062881|SUPERIORITY||Efficacy|85.92||||0.0002|TWO_SIDED|95.0|52.85|97.311|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.311|52.850|0.0002
91585961|NCT05437510|183062881|SUPERIORITY||Efficacy|74.39||||0.0054|TWO_SIDED|95.0|29.077|92.525|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.525|29.077|0.0054
91585962|NCT05437510|183062882|SUPERIORITY||Efficacy|41.89|||<|0.0001|TWO_SIDED|95.0|23.073|56.333|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||56.333|23.073|<0.0001
91585963|NCT05437510|183062882|SUPERIORITY||Efficacy|32.19||||0.1003|TWO_SIDED|95.0|-7.188|57.545|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||57.545|-7.188|0.1003
91585964|NCT05437510|183062882|SUPERIORITY||Efficacy|39.83||||0.0164|TWO_SIDED|95.0|8.449|60.911|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||60.911|8.449|0.0164
91585965|NCT05437510|183062882|SUPERIORITY||Efficacy|64.06||||0.0058|TWO_SIDED|95.0|23.386|84.478|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||84.478|23.386|0.0058
91585966|NCT00147823|183062888|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|Using baseline (6 wk) and two year post operative predicted effects data, and setting desirable power to detect our effects to 80%||The sample size provided at least 80% power at a 5% alpha level to detect a medium to large effect in patients receiving Vitoss alone compared to combination therapy consisting of Vitoss with Bone Marrow Aspirate. Since a random coefficients model was used to analyze the data, the sample size calculation was estimated under this model assuming a 3% attrition rate between all measurement times.||||<0.01
91585967|NCT00147823|183062889|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.01
91585968|NCT02892344|183062908|SUPERIORITY||Mean Difference (Net)|0.182|||<|0.001|TWO_SIDED|95.0|0.148|0.217|||Mixed Models Analysis|||||0.217|0.148|<0.001
91585969|NCT02892344|183062909|SUPERIORITY||Mean Difference (Net)|-0.218|||<|0.001|TWO_SIDED|95.0|-0.293|-0.143|||Mixed Models Analysis|||||-0.143|-0.293|<0.001
91585970|NCT02892344|183062910|SUPERIORITY||Mean Difference (Net)|0.132|||<|0.001|TWO_SIDED|95.0|0.105|0.158|||Mixed Models Analysis|||||0.158|0.105|<0.001
91585971|NCT02892344|183062911|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.145|0.207|||Mixed Models Analysis|||||0.207|0.145|<0.001
91585972|NCT02892344|183062912|SUPERIORITY||Mean Difference (Net)|0.1|||<|0.001|TWO_SIDED|95.0|0.061|0.139|||Mixed Models Analysis|||Pre-dose trough FVC||0.139|0.061|<0.001
91585973|NCT02892344|183062912|SUPERIORITY||Mean Difference (Net)|0.288|||<|0.001|TWO_SIDED|95.0|0.231|0.345|||Mixed Models Analysis|||Pre-dose trough FEF25-75%||0.345|0.231|<0.001
91585974|NCT02892344|183062913|SUPERIORITY||Mean Difference (Net)|27.2|||<|0.001|TWO_SIDED|95.0|22.1|32.4|||Mixed Models Analysis|||Mean Morning PEF||32.4|22.1|<0.001
91585975|NCT02892344|183062913|SUPERIORITY||Mean Difference (Net)|26.1|||<|0.001|TWO_SIDED|95.0|21.0|31.2|||Mixed Models Analysis|||Mean Evening PEF||31.2|21.0|<0.001
91585976|NCT02892344|183062916|SUPERIORITY||Mean Difference (Net)|-0.204|||<|0.001|TWO_SIDED|95.0|-0.277|-0.131|||Mixed Models Analysis|||||-0.131|-0.277|<0.001
91585977|NCT02892344|183062917|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.05|||Mixed Models Analysis|||Night-time number of puffs of rescue medication||-0.05|-0.16|<0.001
91585978|NCT02892344|183062917|SUPERIORITY||Mean Difference (Net)|-0.15|||<|0.001|TWO_SIDED|95.0|-0.22|-0.08|||Mixed Models Analysis|||Daytime number of puffs of rescue medication||-0.08|-0.22|<0.001
91585979|NCT02892344|183062918|SUPERIORITY||Mean Difference (Net)|8.1|||<|0.001|TWO_SIDED|95.0|4.3|11.8|||Mixed Models Analysis|||||11.8|4.3|<0.001
91779411|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7||||0.4861|TWO_SIDED|95.0|-10.5|5.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-10.5|0.4861
91585980|NCT02892344|183062919|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.064|0.234|||Mixed Models Analysis|||||0.234|0.064|<0.001
91585981|NCT02892344|183062922|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.14|0.59|||Regression, Cox|||||0.59|0.14|<0.001
91585982|NCT03938454|183062923|OTHER||Hodges-Lehmann|45.98||||0.0676|TWO_SIDED|95.0|23.5|65.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% percent reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||65.36|23.50|0.0676
91585983|NCT03938454|183062929|OTHER||Hodges-Lehmann|50.2||||0.0259|TWO_SIDED|95.0|27.94|67.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||67.36|27.94|0.0259
91585984|NCT05888103|183062960|SUPERIORITY||LS Mean Difference|-47.5|||<|0.0001|TWO_SIDED|95.0|-52.35|-42.65|||ANCOVA|||||-42.65|-52.35|<0.0001
91585985|NCT05888103|183062961|SUPERIORITY||LS Mean Difference|-69.73|||<|0.0001|TWO_SIDED|95.0|-76.6|-62.86|||ANCOVA|||||-62.86|-76.60|<0.0001
91585986|NCT05888103|183062962|SUPERIORITY||LS Mean Difference|-77.83|||<|0.0001|TWO_SIDED|95.0|-85.86|-69.8|||ANCOVA|||||-69.80|-85.86|<0.0001
91585987|NCT05888103|183062963|SUPERIORITY||LS Mean Difference|-226.61|||<|0.0001|TWO_SIDED|95.0|-244.77|-208.45|||ANCOVA|||||-208.45|-244.77|<0.0001
91585988|NCT05888103|183062964|SUPERIORITY||LS Mean Difference|-31.49|||<|0.0001|TWO_SIDED|95.0|-34.91|-28.07|||ANCOVA|||||-28.07|-34.91|<0.0001
91585989|NCT05888103|183062965|SUPERIORITY||LS Mean Difference|-71.46|||<|0.0001|TWO_SIDED|95.0|-79.24|-63.69|||ANCOVA|||||-63.69|-79.24|<0.0001
91585990|NCT05888103|183062966|SUPERIORITY||LS Mean Difference|2.94||||0.3743|TWO_SIDED|95.0|-3.55|9.42|||ANCOVA|||||9.42|-3.55|0.3743
91585991|NCT05888103|183062967|SUPERIORITY||LS Mean Difference|1.07||||0.4228|TWO_SIDED|95.0|-1.54|3.68|||ANCOVA|||||3.68|-1.54|0.4228
91585992|NCT05888103|183062968|SUPERIORITY||LS Mean Difference|-40.57|||<|0.0001|TWO_SIDED|95.0|-44.57|-36.57|||ANCOVA|||||-36.57|-44.57|<0.0001
91585993|NCT05888103|183062969|SUPERIORITY||LS Mean Difference|-72.34|||<|0.0001|TWO_SIDED|95.0|-79.56|-65.13|||ANCOVA|||||-65.13|-79.56|<0.0001
91585994|NCT05888103|183062970|SUPERIORITY||LS Mean Difference|-36.84|||<|0.0001|TWO_SIDED|95.0|-40.72|-32.96|||ANCOVA|||||-32.96|-40.72|<0.0001
91585995|NCT05888103|183062971|SUPERIORITY||LS Mean Difference|-41.87|||<|0.0001|TWO_SIDED|95.0|-46.28|-37.47|||ANCOVA|||||-37.47|-46.28|<0.0001
91779412|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.1809|TWO_SIDED|95.0|-2.5|13.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-2.5|0.1809
91585996|NCT05888103|183062972|SUPERIORITY||LS Mean Difference|2.05||||0.3011|TWO_SIDED|95.0|-1.84|5.93|||ANCOVA|||||5.93|-1.84|0.3011
91779413|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.856|TWO_SIDED|95.0|-7.1|8.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.5|-7.1|0.8560
91779414|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.2385|TWO_SIDED|95.0|-3.1|12.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.4|-3.1|0.2385
91779415|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.3479|TWO_SIDED|95.0|-4.1|11.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.5|-4.1|0.3479
91779416|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|27.7||||0.0185|TWO_SIDED|95.0|4.7|50.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.6|4.7|0.0185
91779417|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.5471|TWO_SIDED|95.0|-15.8|29.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|-15.8|0.5471
91585997|NCT05888103|183062973|SUPERIORITY||LS Mean Difference|3.13||||0.2403|TWO_SIDED|95.0|-2.09|8.35|||ANCOVA|||||8.35|-2.09|0.2403
91585998|NCT05888103|183062974|SUPERIORITY||LS Mean Difference|-30.27|||<|0.0001|TWO_SIDED|95.0|-40.58|-19.95|||ANCOVA|||||-19.95|-40.58|<0.0001
91585999|NCT05888103|183062975|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.6|0.76|||ANCOVA|||||0.76|0.60|<0.0001
91586000|NCT05888103|183062976|SUPERIORITY||LS Mean Difference|3.01||||0.5877|TWO_SIDED|95.0|-7.88|13.91|||ANCOVA|||||13.91|-7.88|0.5877
91586001|NCT05888103|183062977|SUPERIORITY||LS Mean Difference|-7.96||||0.5019|TWO_SIDED|95.0|-31.17|15.26|||ANCOVA|||||15.26|-31.17|0.5019
91586002|NCT04987307|183062983|SUPERIORITY||Difference percentage (%)|2.1||||0.7|TWO_SIDED|95.0|-8.6|12.8||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using nonresponder imputation (NRI).|Logistic regression model|||||12.8|-8.6|0.70
91586003|NCT04987307|183062983|SUPERIORITY||Difference %|2.0||||0.72|TWO_SIDED|95.0|-8.6|12.6||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||12.6|-8.6|0.72
91779418|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5||||0.0367|TWO_SIDED|95.0|1.5|47.4|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.4|1.5|0.0367
91586004|NCT04987307|183062983|SUPERIORITY||Difference %|3.1||||0.58|TWO_SIDED|95.0|-8.0|14.2||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||14.2|-8.0|0.58
91586005|NCT04987307|183062984|SUPERIORITY||Difference %|-1.1||||0.89|TWO_SIDED|95.0|-16.3|14.2||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||14.2|-16.3|0.89
91779419|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|10.1||||0.3797|TWO_SIDED|95.0|-12.6|32.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.9|-12.6|0.3797
91779420|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4||||0.1557|TWO_SIDED|95.0|-6.3|39.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.1|-6.3|0.1557
91779421|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2||||0.2904|TWO_SIDED|95.0|-10.5|34.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.9|-10.5|0.2904
91779422|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0||||0.0467|TWO_SIDED|95.0|0.4|51.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.6|0.4|0.0467
91779423|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|10.7||||0.4056|TWO_SIDED|95.0|-14.6|36.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.0|-14.6|0.4056
91779424|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|23.3||||0.0738|TWO_SIDED|95.0|-2.3|48.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.9|-2.3|0.0738
91779425|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4||||0.2987|TWO_SIDED|95.0|-12.0|38.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.7|-12.0|0.2987
91779426|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0763|TWO_SIDED|95.0|-2.4|48.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.2|-2.4|0.0763
91779427|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.3396|TWO_SIDED|95.0|-13.1|37.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.6|-13.1|0.3396
91779428|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2||||0.2425|TWO_SIDED|95.0|-89.1|22.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.7|-89.1|0.2425
91779429|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1||||0.0281|TWO_SIDED|95.0|6.8|117.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||117.5|6.8|0.0281
91779430|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.4189|TWO_SIDED|95.0|-33.0|78.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.8|-33.0|0.4189
91779431|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.831|TWO_SIDED|95.0|-49.4|61.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||61.4|-49.4|0.8310
91779432|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|34.8||||0.2161|TWO_SIDED|95.0|-20.6|90.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.1|-20.6|0.2161
91779433|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.8905|TWO_SIDED|95.0|-51.5|59.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.2|-51.5|0.8905
91586006|NCT04987307|183062984|SUPERIORITY||Difference %|4.7||||0.56|TWO_SIDED|95.0|-11.1|20.6||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||20.6|-11.1|0.56
91586007|NCT04987307|183062984|SUPERIORITY||Difference %|4.5||||0.59|TWO_SIDED|95.0|-11.7|20.7||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||20.7|-11.7|0.59
91586008|NCT04987307|183062985|SUPERIORITY||Difference %|4.2||||0.52|TWO_SIDED|95.0|-8.7|17.2||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||17.2|-8.7|0.52
91586009|NCT04987307|183062985|SUPERIORITY||Difference %|0.2||||0.97|TWO_SIDED|95.0|-11.8|12.2||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||12.2|-11.8|0.97
91586010|NCT04987307|183062985|SUPERIORITY||Difference %|1.5||||0.82|TWO_SIDED|95.0|-11.1|14.0||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression mode|||||14.0|-11.1|0.82
91586011|NCT04987307|183062986|SUPERIORITY||Difference %|2.6||||0.72|TWO_SIDED|95.0|-11.6|16.7||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||16.7|-11.6|0.72
91586012|NCT04987307|183062986|SUPERIORITY||Difference %|8.3||||0.28|TWO_SIDED|95.0|-6.6|23.1||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||23.1|-6.6|0.28
91710802|NCT02258217|183314015|EQUIVALENCE|"We created a difference in PCS score variable. This was calculated as follows:~PCS score (new relapse) - PCS score (after treatment of current relapse). This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|4.42||0.03|TWO_SIDED|95.0|-3.67|-0.18|||Paired t-test, two sided|||"We compared the two PCS scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post PCS scores."||-0.18|-3.67|0.03
91586013|NCT04987307|183062986|SUPERIORITY||Difference %|8.1||||0.3|TWO_SIDED|95.0|-7.1|23.3||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||23.3|-7.1|0.30
91586014|NCT04987307|183062987|SUPERIORITY||Difference %|8.46||||0.11|TWO_SIDED|95.0|0.0|16.9||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||16.9|0.0|0.11
91586015|NCT04987307|183062987|SUPERIORITY||Difference %|2.18||||0.46|TWO_SIDED|95.0|-3.4|7.7||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||7.7|-3.4|0.46
91586016|NCT04987307|183062987|SUPERIORITY||Difference %|0.14||||0.94|TWO_SIDED|95.0|-4.0|4.3||P-value was unadjusted and obtained from logistic regression model including stratification factors as covariates (prior experience with ≥1 biologic or targeted small molecule, corticosteroid use at randomization) using NRI.|Logistic regression model|||||4.3|-4.0|0.94
91586017|NCT04987307|183062988|SUPERIORITY||Treatment Difference|0.2||||0.39|TWO_SIDED|95.0|-0.3|0.7||P-value was obtained from the analysis of covariance (ANCOVA) model which includes stratification factors (prior experience with ≥ 1 biologic or targeted small molecule, corticosteroid use at randomization) as covariates.|ANCOVA|||||0.7|-0.3|0.39
91586018|NCT04987307|183062988|SUPERIORITY||Treatment Difference|0.2||||0.49|TWO_SIDED|95.0|-0.3|0.7||P-value was obtained from the ANCOVA model which includes stratification factors (prior experience with ≥ 1 biologic or targeted small molecule, corticosteroid use at randomization) as covariates.|ANCOVA|||||0.7|-0.3|0.49
91586019|NCT04987307|183062988|SUPERIORITY||Treatment Difference|0.1||||0.76|TWO_SIDED|95.0|-0.5|0.6||P-value was obtained from the ANCOVA model which includes stratification factors (prior experience with ≥ 1 biologic or targeted small molecule, corticosteroid use at randomization) as covariates.|ANCOVA|||||0.6|-0.5|0.76
91586020|NCT06795204|183063039|NON_INFERIORITY|Upper boundary of 90% CI should not exceed the margin of 10ms|Mean Difference (Final Values)|4.1|||<|0.05|TWO_SIDED|90.0|1.29|6.82|||Mixed Models Analysis||Upper boundary is 6.82ms, does not cross margin of the 10ms|1 min post-dose; worse case for the study drug||6.82|1.29|<0.05
91586021|NCT06795204|183063039|NON_INFERIORITY|Upper boundary of 90% CI should not exceed the margin of 10ms|Mean Difference (Final Values)|12.4|||<|0.05|TWO_SIDED|90.0|10.66|14.1|||Mixed Models Analysis||Upper boundary is 14.10ms, cross margin of the 10ms|3 h post-dose; worse case of the positive control||14.10|10.66|<0.05
91586022|NCT06795204|183063039|NON_INFERIORITY|Upper boundary of 90% CI should not exceed the margin of 10ms|Mean Difference (Final Values)|11.8|||<|0.05|TWO_SIDED|90.0|10.07|13.55|||Mixed Models Analysis||Upper boundary is 13.55ms, cross margin of the 10ms|4 h post-dose, second worse case of the positive control||13.55|10.07|<0.05
91586023|NCT03226392|183063073|SUPERIORITY||Mean Difference (Net)|-0.031||||0.214|TWO_SIDED|95.0|-0.08|0.018|||ANCOVA|||||0.018|-0.080|0.214
91586024|NCT03226392|183063074|SUPERIORITY||Mean Difference (Net)|-0.1||||0.035|TWO_SIDED|0.035|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.035
91586025|NCT03226392|183063075|SUPERIORITY||Mean Difference (Net)|0.093||||0.893|TWO_SIDED|95.0|-0.2|0.17|||ANCOVA|||||0.17|-0.20|0.893
91586026|NCT03226392|183063076|SUPERIORITY||Mean Difference (Net)|0.061||||0.448|TWO_SIDED|95.0|-0.07|0.17|||ANCOVA|||||0.17|-0.07|0.448
91586027|NCT04266301|183063110|SUPERIORITY||Hazard Ratio (HR)|0.847||||0.0825|TWO_SIDED|95.0|0.671|1.07||P Value is 1-sided|Log Rank|Log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very high risk MDS, CMML-2) as per IRT||||1.070|0.671|0.0825
91586028|NCT04266301|183063111|SUPERIORITY||Hazard Ratio (HR)|0.863|||||TWO_SIDED|95.0|0.693|1.076||||||||1.076|0.693|
91586029|NCT04266301|183063112|SUPERIORITY||Hazard Ratio (HR)|0.921||||0.2132|TWO_SIDED|95.0|0.75|1.13||P Value is 1-sided|Log Rank|log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very High risk MDS, CMML-2) as per IRT||||1.130|0.750|0.2132
91586030|NCT04266301|183063113|SUPERIORITY|||||||0.4692||||||P Value is 1-sided|negative binomial regression model|negative binomial regression model with log link stratified by randomization stratification factor as per IRT and baseline transfusion status||||||0.4692
91586031|NCT04266301|183063114|SUPERIORITY||Odds Ratio (OR)|0.95||||0.4865|TWO_SIDED|95.0|0.7|1.4||P Value is 1-sided|Cochran-Mantel-Haenszel|exact CMH Chi-square statistic, adjusting for randomization stratification factor as per IRT.||||1.4|0.7|0.4865
91586032|NCT04266301|183063115|SUPERIORITY||Odds Ratio (OR)|1.48||||0.5743|TWO_SIDED|95.0|1.0|2.2||P Value is 1-sided|Cochran-Mantel-Haenszel|exact CMH Chi-square statistic, adjusting for randomization stratification factor as per IRT.||||2.2|1|0.5743
91586033|NCT04266301|183063116|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2126|TWO_SIDED|95.0|0.8|1.7||P Value is 1-sided|Cochran-Mantel-Haenszel|exact CMH Chi-square statistic, adjusting for randomization stratification factor as per IRT.||||1.7|0.8|0.2126
91586034|NCT04266301|183063119|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.576|0.875||||||||0.875|0.576|
91586035|NCT04266301|183063120|SUPERIORITY||Hazard Ratio (HR)|0.815|||||TWO_SIDED|95.0|0.64|1.038||||||||1.038|0.640|
91586036|NCT03215758|183063130|SUPERIORITY||Mean Difference (Net)|0.0238||||0.088|TWO_SIDED|95.0|-0.006|0.088|||ANCOVA|||||0.088|-0.006|0.088
91521208|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3073|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||0.8|-0.3|0.3073
91586037|NCT03215758|183063131|SUPERIORITY||Mean Difference (Net)|-0.06||||0.278|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.278
91586038|NCT03215758|183063132|SUPERIORITY||Mean Difference (Net)|-0.08||||0.429|TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||||0.13|-0.30|0.429
91586039|NCT03215758|183063133|SUPERIORITY||Mean Difference (Net)|0.069||||0.777|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.777
91586040|NCT02977988|183063145|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||150 day period was selected for this outcome for a conceptual reason; that being, residential treatment average length of stay||||<0.05
91586041|NCT02977988|183063146|SUPERIORITY||||||<|0.05|||||||Negative Binomial Hurdle Model|||||||<0.05
91586042|NCT02977988|183063147|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91586043|NCT05630001|183063179|NON_INFERIORITY|Non-inferiority and primary objective was considered met if the lower bound of the estimated two-sided 95% confidence interval (CI) is greater than -1 g/dL.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91586044|NCT05630001|183063180|SUPERIORITY|Superiority and the key secondary objective was considered met if the lower bound of the estimated two-sided 95% CI was \> 0 g/dL.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91586045|NCT03946670|183063198|SUPERIORITY|||||||0.769|||||||Cochran-Mantel-Haenszel|stratified by the randomization stratification factor IPSS-R category||||||0.769
91586046|NCT03946670|183063199|SUPERIORITY||Cox Proportional Hazard|0.749||||0.1022|TWO_SIDED|95.0|0.479|1.173|||Log Rank|stratified by the randomization stratification factor IPSS-R category||||1.173|0.479|0.1022
91586047|NCT03946670|183063200|SUPERIORITY||Hazard Ratio (HR)|0.795|||||TWO_SIDED|95.0|0.521|1.212|||||Cox model stratified by IPSS-R score as per IRT|||1.212|0.521|
91586048|NCT03946670|183063201|SUPERIORITY||Hazard Ratio (HR)|0.808|||||TWO_SIDED|95.0|0.542|1.205|||||Cox model stratified by IPSS-R score as per Interactive Response Technology (IRT)|||1.205|0.542|
91586049|NCT03946670|183063202|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.589|1.343|||||Cox model stratified by IPSS-R score as per IRT|||1.343|0.589|
91586050|NCT03946670|183063203|SUPERIORITY||Hazard Ratio (HR)|0.906|||||TWO_SIDED|95.0|0.57|1.44|||||Cox model stratified by IPSS-R score as per IRT|||1.440|0.570|
91586051|NCT03946670|183063205|SUPERIORITY||Hazard Ratio (HR)|0.664|||||TWO_SIDED|95.0|0.24|1.838|||||Cox model stratified by IPSS-R score as per IRT|||1.838|0.240|
91586052|NCT03946670|183063206|SUPERIORITY||Hazard Ratio (HR)|1.237|||||TWO_SIDED|95.0|0.588|2.601|||||Cox model stratified by IPSS-R score as per IRT|||2.601|0.588|
91586053|NCT04652726|183063214|SUPERIORITY||LS Mean|-28.54|||<|0.0001|TWO_SIDED|95.0|-35.81|-21.27|||ANCOVA|||||-21.27|-35.81|<.0001
91586054|NCT04652726|183063215|SUPERIORITY||LS Mean|-29.3|||<|0.0001|TWO_SIDED|95.0|-36.24|-22.36|||MMRM|||||-22.36|-36.24|<.0001
91586055|NCT04652726|183063216|SUPERIORITY||LS Mean|-49.99|||<|0.0001|TWO_SIDED|95.0|-63.18|-36.81|||ANCOVA|||||-36.81|-63.18|<.0001
91586056|NCT04652726|183063217|SUPERIORITY||LS Mean|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.68|-19.73|||ANCOVA|||||-19.73|-31.68|<.0001
91586057|NCT04652726|183063218|SUPERIORITY||LS Mean|-6.18||||0.1419|TWO_SIDED|95.0|-17.48|5.12|||ANCOVA|||||5.12|-17.48|0.1419
91586058|NCT04652726|183063219|SUPERIORITY||LS Mean|-26.8|||<|0.0001|TWO_SIDED|95.0|-33.63|-19.97|||ANCOVA|||||-19.97|-33.63|<.0001
91779434|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8||||0.1597|TWO_SIDED|95.0|-124.2|20.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.6|-124.2|0.1597
91708815|NCT02362425|183310793|SUPERIORITY|An a priori power calculation, with power at 80% and a two-sided α of 0·05, determined that n=76 participants (n=38 per group) would be required to detect a statistically significant post-intervention difference in plasma glutathione (GSH) concentration between NAC and placebo groups. After the primary endpoint was changed, re-evaluation of the sample size determined that a larger sample (total n=182) would be required. As per protocol, the study was completed at this time.|Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.4|1.6|||Regression, Linear|Model comparing 12 m corrected 15-F2t-isoprostane conc. controlling for pre-intervention value. Investigated covariates: smoking and drinking status.||Null Hypothesis: In RYR1-RM myopathy patients, there will be no statistically significant difference in corrected 15-F2t-isoprostane concentration and/or corrected 15=f2t-Isop:PGR2alpha ratio between NAC and placebo groups at month 12, after controlling for established a priori confounders.||1.6|-1.4|0.88
91779435|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|70.9||||0.0525|TWO_SIDED|95.0|-0.8|142.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.6|-0.8|0.0525
91586059|NCT04652726|183063220|SUPERIORITY||LS Mean|-19.2|||<|0.0001|TWO_SIDED|95.0|-24.65|-13.75|||ANCOVA|||||-13.75|-24.65|<.0001
91586060|NCT03780725|183063241|OTHER||Mean relative change from baseline|17.1|STANDARD_DEVIATION|47.7|||||||||||Mean relative change from baseline (Cycle 1) to on treatment (Cycle 2) is reported.|"The mean relative change is calculated as first deriving the relative change from baseline for each selected lesion at each time point (96hours, 144hours):~100 \* (SUVpeak,lesion,timepoint,cycle2 - SUVpeak,lesion,timepoint,cycle1) / SUVpeak,lesion,timepoint,cycle1 Then, we calculate the mean over all evaluable lesions (at each time point) At last, the mean relative change is the lower mean value across time points."||||
91586061|NCT03780725|183063242|OTHER||Mean relative change from baseline|-5.9|STANDARD_DEVIATION|28.2|||||||||||Mean relative change from baseline (Cycle 1) to on treatment (Cycle 2) is reported.|"The mean relative change is calculated as first deriving the relative change from baseline for each selected lesion at each time point (96hours, 144hours):~100 \* (SUVpeak,lesion,timepoint,cycle2 - SUVpeak,lesion,timepoint,cycle1) / SUVpeak,lesion,timepoint,cycle1 Then, we calculate the mean over all evaluable lesions (at each time point) At last, the mean relative change is the lower mean value across time points."||||
91586062|NCT05192382|183063258|SUPERIORITY||Odds Ratio (OR)|42.806|||<|0.0001|TWO_SIDED|95.0|8.444|455.821|||exact logistic regression model|||Treatment comparison of all participants receiving paltusotine irrespective of dose levels with Placebo has been presented.||455.821|8.444|<0.0001
91586063|NCT05192382|183063259|SUPERIORITY||least square mean difference|-0.906|||<|0.0001|TWO_SIDED|95.0|-1.106|-0.706|||ANCOVA|||||-0.706|-1.106|<0.0001
91586064|NCT05192382|183063260|SUPERIORITY||Odds Ratio (OR)|18.319|||<|0.0001|TWO_SIDED|95.0|5.637|79.156|||exact logistic regression model|||Treatment comparison of all participants receiving paltusotine irrespective of dose levels with Placebo has been presented.||79.156|5.637|<0.0001
91586065|NCT05192382|183063261|SUPERIORITY||Odds Ratio (OR)|7.588|||<|0.0001|TWO_SIDED|95.0|2.776|23.483|||exact logistic regression model|||Treatment comparison of all participants receiving paltusotine irrespective of dose levels with Placebo has been presented.||23.483|2.776|<0.0001
91586066|NCT05192382|183063262|SUPERIORITY||least square mean difference|-5.423||||0.0039|TWO_SIDED|95.0|-9.07|-1.776|||ANCOVA|||||-1.776|-9.070|0.0039
91586067|NCT02604199|183063289|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.048||0.081|TWO_SIDED|95.0|-0.183|0.011||Mixed effect model repeat measurement (MMRM) includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|MMRM|Within-subject covariance is unstructured.||||0.011|-0.183|0.0810
91586068|NCT02604199|183063289|SUPERIORITY||LS Mean Difference|-0.309|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.406|-0.212||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.212|-0.406|<.0001
91586069|NCT02604199|183063289|SUPERIORITY||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.322|-0.124||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.124|-0.322|<.0001
91586070|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.089|STANDARD_ERROR_OF_MEAN|0.046||0.0583|TWO_SIDED|95.0|-0.181|0.003||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.003|-0.181|0.0583
91586071|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.176|STANDARD_ERROR_OF_MEAN|0.045||0.003|TWO_SIDED|95.0|-0.267|-0.085||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||-0.085|-0.267|0.003
91586072|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.087|STANDARD_ERROR_OF_MEAN|0.047||0.067|TWO_SIDED|95.0|-0.181|0.006||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.006|-0.181|0.0670
91586073|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0875|TWO_SIDED|95.0|-0.151|0.011||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||0.011|-0.151|0.0875
91586074|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.179|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.259|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.100|-0.259|<.0001
91586075|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0099|TWO_SIDED|95.0|-0.191|-0.027||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.027|-0.191|0.0099
91586076|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.143|STANDARD_ERROR_OF_MEAN|0.043||0.0017|TWO_SIDED|95.0|-0.229|-0.057||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.057|-0.229|0.0017
91586077|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|-0.349|-0.18||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.180|-0.349|<.0001
91586078|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.122|STANDARD_ERROR_OF_MEAN|0.043||0.0072|TWO_SIDED|95.0|-0.209|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.035|-0.209|0.0072
91779436|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1||||0.5294|TWO_SIDED|95.0|-49.3|95.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||95.4|-49.3|0.5294
91586079|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.118|STANDARD_ERROR_OF_MEAN|0.039||0.0043|TWO_SIDED|95.0|-0.197|-0.039||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.039|-0.197|0.0043
91708816|NCT02362425|183310794|SUPERIORITY||Mean Difference (Final Values)|23.9||||0.11|TWO_SIDED|95.0|-5.5|53.4||Model controlled for six-month(pre-intervention) distance and treatment group. Investigated covariates: height|Regression, Linear|||In RYR1-RM myopathy patients, there will be no statistically significant difference in 6MWT (six minute walk test) total distance between NAC and placebo groups at month 12, after controlling for established a priori confounders.||53.4|-5.5|.11
91586080|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.298|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.376|-0.221||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.221|-0.376|< 0.0001
91586081|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.181|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.261|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.100|-0.261|<.0001
91586082|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.048||0.0084|TWO_SIDED|95.0|-0.228|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.035|-0.228|0.0084
91586083|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.338|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.433|-0.243||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.243|-0.433|<.0001
91586084|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.206|STANDARD_ERROR_OF_MEAN|0.049||0.0001|TWO_SIDED|95.0|-0.304|-0.108||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.108|-0.304|0.0001
91586085|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.096|STANDARD_ERROR_OF_MEAN|0.05||0.0589|TWO_SIDED|95.0|-0.195|0.004||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||0.004|-0.195|0.0589
91586086|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.335|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.433|-0.236||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.236|-0.433|<.0001
91708817|NCT02362425|183310795|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-3.6|0.7|||Regression, Linear|||||0.7|-3.6|0.14
91586087|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.239|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.34|-0.137||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.137|-0.340|<.0001
91586088|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.052||0.0138|TWO_SIDED|95.0|-0.236|-0.028||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.028|-0.236|0.0138
91586089|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.355|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.458|-0.252||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.252|-0.458|<.0001
91586090|NCT02604199|183063290|SUPERIORITY||LS Mean|-0.223|STANDARD_ERROR_OF_MEAN|0.053||0.0001|TWO_SIDED|95.0|-0.329|-0.117||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.117|-0.329|0.0001
91586091|NCT02604212|183063300|SUPERIORITY||LS Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.102||0.6815|TWO_SIDED|95.0|-0.243|0.159|||MMRM|||||0.159|-0.243|0.6815
91647330|NCT00446134|183186473|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|5.71|STANDARD_DEVIATION|5.0||0.611|TWO_SIDED|95.0|-10.76|22.19|||Fisher Exact|||||22.19|-10.76|0.611
91708818|NCT02362425|183310796|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.62
91586092|NCT02604212|183063300|SUPERIORITY||LS Mean Difference|-0.438|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.638|-0.237|||MMRM|||||-0.237|-0.638|<.0001
91586093|NCT02604212|183063300|SUPERIORITY||LS Mean Difference|-0.396|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.569|-0.223|||MMRM|||||-0.223|-0.569|<.0001
91708819|NCT02362425|183310797|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.05|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||||0.0|-1.1|0.05
91586094|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.208|STANDARD_ERROR_OF_MEAN|0.083||0.0131|TWO_SIDED|95.0|-0.372|-0.044|||MMRM|||Day 15||-0.044|-0.372|0.0131
91586095|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.247|STANDARD_ERROR_OF_MEAN|0.084||0.0036|TWO_SIDED|95.0|-0.412|-0.082|||MMRM|||Day 15||-0.082|-0.412|0.0036
91586096|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.039|STANDARD_ERROR_OF_MEAN|0.077||0.6136|TWO_SIDED|95.0|-0.192|0.113|||MMRM|||Day 15||0.113|-0.192|0.6136
91586097|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.085|STANDARD_ERROR_OF_MEAN|0.083||0.3104|TWO_SIDED|95.0|-0.249|0.08|||MMRM|||Day 29||0.080|-0.249|0.3104
91586098|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.174|STANDARD_ERROR_OF_MEAN|0.084||0.0401|TWO_SIDED|95.0|-0.34|-0.008|||MMRM|||Day 29||-0.008|-0.340|0.0401
91586099|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.077||0.2494|TWO_SIDED|95.0|-0.242|0.063|||MMRM|||Day 29||0.063|-0.242|0.2494
91586100|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.085||0.0149|TWO_SIDED|95.0|-0.38|-0.042|||MMRM|||Day 43||-0.042|-0.380|0.0149
91586101|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.319|STANDARD_ERROR_OF_MEAN|0.086||0.0003|TWO_SIDED|95.0|-0.489|-0.149|||MMRM|||Day 43||-0.149|-0.489|0.0003
91586102|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.108|STANDARD_ERROR_OF_MEAN|0.078||0.1655|TWO_SIDED|95.0|-0.262|0.045|||MMRM|||Day 29||0.045|-0.262|0.1655
91586103|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.088||0.0889|TWO_SIDED|95.0|-0.324|0.023|||MMRM|||Day 57||0.023|-0.324|0.0889
91586104|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.322|STANDARD_ERROR_OF_MEAN|0.088||0.0004|TWO_SIDED|95.0|-0.497|-0.147|||MMRM|||Day 57||-0.147|-0.497|0.0004
91586105|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.078||0.0298|TWO_SIDED|95.0|-0.326|-0.017|||MMRM|||Day 57||-0.017|-0.326|0.0298
91586106|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.184|STANDARD_ERROR_OF_MEAN|0.089||0.0415|TWO_SIDED|95.0|-0.361|-0.007|||MMRM|||Day 71||-0.007|-0.361|0.0415
91586107|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.441|STANDARD_ERROR_OF_MEAN|0.091|<|0.0001|TWO_SIDED|95.0|-0.62|-0.261|||MMRM|||Day 71||-0.261|-0.620|<.0001
91647331|NCT00446134|183186473|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.98|STANDARD_DEVIATION|5.0||0.736|TWO_SIDED|95.0|-13.67|19.63|||Fisher Exact|||||19.63|-13.67|0.736
91647332|NCT00446134|183186473|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|7.04|STANDARD_DEVIATION|5.0||0.485|TWO_SIDED|95.0|-9.28|23.35|||Fisher Exact|||||23.35|-9.28|0.485
91708820|NCT02362425|183310798|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.1|0.6|||t-test, 2 sided|||||0.6|-2.1|0.25
91708821|NCT02362425|183310799|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.05|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||||0.0|-2.1|0.05
91708822|NCT02362425|183310800|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.09|TWO_SIDED|95.0|-0.6|7.3|||t-test, 2 sided|||||7.3|-0.6|0.09
91708823|NCT02362425|183310801|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.69|TWO_SIDED|95.0|-1.3|2.0|||t-test, 2 sided|||||2.0|-1.3|0.69
91708824|NCT02362425|183310802|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.31|TWO_SIDED|95.0|-3.5|1.1|||t-test, 2 sided|||||1.1|-3.5|0.31
91708825|NCT02362425|183310803|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.22|TWO_SIDED|95.0|-0.8|3.0|||t-test, 2 sided|||||3.0|-0.8|0.22
91586108|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.079||0.0015|TWO_SIDED|95.0|-0.413|-0.1|||MMRM|||Day 71||-0.100|-0.413|0.0015
91586109|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.092||0.351|TWO_SIDED|95.0|-0.268|0.096|||MMRM|||Day 85||0.096|-0.268|0.3510
91586110|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.59|-0.219|||MMRM|||Day 85||-0.219|-0.590|<.0001
91586111|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.318|STANDARD_ERROR_OF_MEAN|0.082||0.0002|TWO_SIDED|95.0|-0.481|-0.156|||MMRM|||Day 85||-0.156|-0.481|0.0002
91586112|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.151|STANDARD_ERROR_OF_MEAN|0.096||0.1198|TWO_SIDED|95.0|-0.341|0.04|||MMRM|||Day 99||0.040|-0.341|0.1198
91586113|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.516|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.708|-0.325|||MMRM|||Day 99||-0.325|-0.708|<.0001
91586114|NCT02604212|183063301|SUPERIORITY||LS Mean Difference|-0.366|STANDARD_ERROR_OF_MEAN|0.085|<|0.0001|TWO_SIDED|95.0|-0.535|-0.197|||MMRM|||Day 99||-0.197|-0.535|<.0001
91586115|NCT02604212|183063302|SUPERIORITY|||||||0.0867|||||||Fisher Exact|||||||0.0867
91779437|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.9126|TWO_SIDED|95.0|-75.7|67.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.7|-75.7|0.9126
91779438|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|34.6||||0.3418|TWO_SIDED|95.0|-37.1|106.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||106.3|-37.1|0.3418
91779439|NCT01746901|183439330|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.8833|TWO_SIDED|95.0|-77.0|66.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.4|-77.0|0.8833
91779440|NCT01746901|183439331|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6||||0.0041|TWO_SIDED|95.0|-6.1|-1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.2|-6.1|0.0041
91779441|NCT01746901|183439331|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0006|TWO_SIDED|95.0|1.9|6.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.8|1.9|0.0006
91779442|NCT01746901|183439331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8765|TWO_SIDED|95.0|-2.7|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-2.7|0.8765
91586116|NCT02604212|183063302|SUPERIORITY|||||||0.6285|||||||Fisher Exact|||||||0.6285
91586117|NCT02604212|183063302|SUPERIORITY|||||||0.7214|||||||Fisher Exact|||||||0.7214
91586118|NCT02604212|183063303|SUPERIORITY|||||||0.0325|||||||Fisher Exact|||||||0.0325
91586119|NCT02604212|183063303|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
91586120|NCT02604212|183063303|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91779443|NCT01746901|183439331|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.4746|TWO_SIDED|95.0|-1.6|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-1.6|0.4746
91779444|NCT01746901|183439331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.4607|TWO_SIDED|95.0|-3.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.3|0.4607
91779445|NCT01746901|183439331|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.2316|TWO_SIDED|95.0|-1.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-1.0|0.2316
91779446|NCT01746901|183439332|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8|||<|0.0001|TWO_SIDED|95.0|26.4|51.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.3|26.4|<0.0001
91779447|NCT01746901|183439332|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0136|TWO_SIDED|95.0|3.3|28.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.3|3.3|0.0136
91586121|NCT02604212|183063304|SUPERIORITY|||||||0.0824|||||||Fisher Exact|||||||0.0824
91586122|NCT02604212|183063304|SUPERIORITY|||||||0.2217|||||||Fisher Exact|||||||0.2217
91586123|NCT02604212|183063304|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
91586124|NCT02604212|183063305|SUPERIORITY|||||||0.0625|||||||Fisher Exact|||||||0.0625
91586125|NCT02604212|183063305|SUPERIORITY|||||||0.0684|||||||Fisher Exact|||||||0.0684
91586126|NCT02604212|183063305|SUPERIORITY|||||||0.2105|||||||Fisher Exact|||||||0.2105
91586127|NCT02604212|183063306|SUPERIORITY|||||||0.175|||||||Fisher Exact|||||||0.1750
91586128|NCT02604212|183063306|SUPERIORITY|||||||0.0229|||||||Fisher Exact|||||||0.0229
91586129|NCT02604212|183063306|SUPERIORITY|||||||0.0294|||||||Fisher Exact|||||||0.0294
91586130|NCT02604212|183063307|SUPERIORITY|||||||0.4615|||||||Fisher Exact|||||||0.4615
91586131|NCT02604212|183063307|SUPERIORITY|||||||0.0508|||||||Fisher Exact|||||||0.0508
91586132|NCT02604212|183063307|SUPERIORITY|||||||0.0769|||||||Fisher Exact|||||||0.0769
91586133|NCT02604212|183063308|SUPERIORITY|||||||0.0699|||||||Fisher Exact|||||||0.0699
91586134|NCT02604212|183063308|SUPERIORITY|||||||0.0179|||||||Fisher Exact|||||||0.0179
91586135|NCT02604212|183063308|SUPERIORITY|||||||0.043|||||||Fisher Exact|||||||0.0430
91586136|NCT02604212|183063309|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91586137|NCT02604212|183063309|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
91586138|NCT02604212|183063309|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
91586139|NCT04659863|183063319|OTHER||Mean Difference (Net)|-33.25|||||TWO_SIDED|95.0|-59.17|-7.34||||||||-7.34|-59.17|
91586140|NCT02076178|183063351|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir||||<0.01
91647333|NCT00446134|183186473|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|9.77|STANDARD_DEVIATION|5.0||0.295|TWO_SIDED|95.0|-6.72|26.26|||Fisher Exact|||||26.26|-6.72|0.295
91647334|NCT00446134|183186473|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.73|STANDARD_DEVIATION|5.0||0.864|TWO_SIDED|95.0|-13.84|19.3|||Fisher Exact|||||19.3|-13.84|0.864
91647335|NCT00446134|183186474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_DEVIATION|5.0||0.0304|TWO_SIDED|95.0|2.31|30.57|||Chi-squared|||||30.57|2.31|0.0304
91647336|NCT00446134|183186474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.1|STANDARD_DEVIATION|5.0||0.0293|TWO_SIDED|95.0|3.22|31.06|||Chi-squared|||||31.06|3.22|0.0293
91647337|NCT00446134|183186474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_DEVIATION|5.0||0.5816|TWO_SIDED|95.0|-10.41|20.24|||Chi-squared|||||20.24|-10.41|0.5816
91586141|NCT05358717|183063385|SUPERIORITY||LS Mean Difference|-15.97|||<|0.0001|TWO_SIDED|95.0|-23.59|-8.34|||Mixed Models Analysis|||||-8.34|-23.59|< 0.0001
91586142|NCT05358717|183063385|SUPERIORITY||LS Mean Difference|-27.28|||<|0.0001|TWO_SIDED|95.0|-34.45|-20.1|||Mixed Models Analysis|||||-20.10|-34.45|< 0.0001
91586143|NCT02640157|183063390|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-5.6|3.1||||||Difference in SVR12 rates (Arm A - Arm B).||3.1|-5.6|
91586144|NCT02640157|183063390|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|percentage of participants|95.3|||||TWO_SIDED|97.5|92.2|98.4||||||||98.4|92.2|
91647338|NCT00446134|183186475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
91708826|NCT02362425|183310804|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||||2.4|-2.6|0.93
91708827|NCT02362425|183310805|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||t-test, 2 sided|||||0.8|-1.3|0.66
91586145|NCT02640157|183063390|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|97.5|-6.2|3.7||||||Difference in SVR12 rates (Arm A - Arm B).||3.7|-6.2|
91647339|NCT00446134|183186475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.73|14.73|||Fisher Exact|||||14.73|-14.73|0.9999
91647340|NCT00446134|183186475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.11|15.71|||Fisher Exact|||||15.71|-14.11|0.9999
91647341|NCT00446134|183186475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
91647342|NCT00446134|183186475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.76|15.59|||Fisher Exact|||||15.59|-14.76|0.9999
91647343|NCT00446134|183186475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-15.71|14.11|||Fisher Exact|||||14.11|-15.71|0.9999
91647344|NCT02524665|183186489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.67|STANDARD_DEVIATION|61.97||0.0769||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used|Wilcoxon signed-rank test||Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.0769
91647345|NCT02524665|183186489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.77|STANDARD_DEVIATION|33.73||0.6698||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6698
91647346|NCT02524665|183186489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66|STANDARD_DEVIATION|17.59||0.6854||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6854
91647347|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|74.55||0.5031||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.5031
91647348|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|STANDARD_DEVIATION|99.76||0.2464||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.2464
91708828|NCT02362425|183310806|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.09|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||||4.6|-0.4|0.09
91708829|NCT02362425|183310807|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.09|TWO_SIDED|95.0|-0.7|9.0|||t-test, 2 sided|||||9.0|-0.7|0.09
91647349|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|STANDARD_DEVIATION|65.22||0.8894||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.8894
91647350|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.98|STANDARD_ERROR_OF_MEAN|46.04||0.6722||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.6722
91647351|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_DEVIATION|39.59||0.3352||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.3352
91647352|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|STANDARD_DEVIATION|35.46||0.9323||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9323
91647353|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|STANDARD_DEVIATION|26.05||0.3513||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.3513
91647354|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_DEVIATION|22.97||0.8199||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.8199
91647355|NCT02524665|183186490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|17.83||0.9616||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9616
91647356|NCT02524665|183186491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 1|||||1.0000
91708830|NCT02362425|183310808|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.15|TWO_SIDED|95.0|-13.4|2.4|||t-test, 2 sided|||||2.4|-13.4|0.15
91708831|NCT02362425|183310809|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.08|TWO_SIDED|95.0|-13.7|1.0|||t-test, 2 sided|||||1.0|-13.7|0.08
91647357|NCT02524665|183186491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.66||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.|||||0.7500
91647358|NCT02524665|183186491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||0.7539||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.|||||0.7539
91647359|NCT02524665|183186491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.87||0.3071||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 8|||||0.3071
91647360|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.|||||0.5000
91647361|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.52||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.|||||1.0000
91647362|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.|||||1.0000
91647363|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.|||||0
91647364|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||1.0000
91647365|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0
91647366|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0
91647367|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
91708832|NCT02362425|183310810|SUPERIORITY||Mean Difference (Final Values)|-16.27||||0.39|TWO_SIDED|95.0|-80.1|47.5|||t-test, 2 sided|||||47.5|-80.1|0.39
91708833|NCT02362425|183310811|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.57|TWO_SIDED|95.0|-59.5|39.5|||t-test, 2 sided|||||39.5|-59.5|0.57
91586146|NCT02640157|183063391|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-4.8|4.0||||||Difference in SVR12 rates (Arm C - Arm A)||4.0|-4.8|
91586147|NCT02640157|183063391|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Percentage of participants|94.9|||||TWO_SIDED|97.5|91.0|98.8||||||||98.8|91.0|
91586148|NCT02640157|183063391|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|97.5|-5.4|4.6||||||||4.6|-5.4|
91586149|NCT00710021|183063409|SUPERIORITY_OR_OTHER|||||||0.53||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.53
91586150|NCT00710021|183063410|SUPERIORITY_OR_OTHER|||||||0.038||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.038
91708834|NCT02362425|183310812|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.12|TWO_SIDED|95.0|-5.0|0.6|||t-test, 2 sided|||||0.6|-5.0|0.12
91586151|NCT00710021|183063411|SUPERIORITY_OR_OTHER|||||||0.047||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.047
91586152|NCT00710021|183063412|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.12
91586153|NCT00710021|183063413|SUPERIORITY_OR_OTHER|||||||0.31||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.31
91586154|NCT00710021|183063414|SUPERIORITY_OR_OTHER|||||||0.019||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.019
91586155|NCT00710021|183063415|SUPERIORITY_OR_OTHER|||||||0.28||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.28
91586156|NCT00710021|183063416|SUPERIORITY_OR_OTHER|||||||0.05||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.050
91586157|NCT00710021|183063417|SUPERIORITY_OR_OTHER|||||||0.29||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.29
91586158|NCT00710021|183063418|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.014
91586159|NCT00710021|183063419|SUPERIORITY_OR_OTHER|||||||0.96||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.96
91586160|NCT00710021|183063420|SUPERIORITY_OR_OTHER|||||||0.67||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.67
91586161|NCT00710021|183063421|SUPERIORITY_OR_OTHER|||||||0.59||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.59
91586162|NCT00710021|183063422|SUPERIORITY_OR_OTHER|||||||0.65||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.65
91586163|NCT00710021|183063423|SUPERIORITY_OR_OTHER|||||||0.86||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.86
91586164|NCT00710021|183063424|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586165|NCT00710021|183063425|SUPERIORITY_OR_OTHER|||||||0.62||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.||||||0.62
91586166|NCT00710021|183063426|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586167|NCT00710021|183063427|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586168|NCT00710021|183063428|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91708835|NCT02362425|183310813|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.76|TWO_SIDED|95.0|-3.6|2.7|||t-test, 2 sided|||||2.7|-3.6|0.76
91708836|NCT02362425|183310814|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.72|TWO_SIDED|95.0|-2.5|3.5|||t-test, 2 sided|||||3.5|-2.5|0.72
91708837|NCT02362425|183310815|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.7|TWO_SIDED|95.0|-1.8|2.7|||t-test, 2 sided|||||2.7|-1.8|0.70
91708838|NCT02362425|183310816|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.88|TWO_SIDED|95.0|-2.8|3.3|||t-test, 2 sided|||||3.3|-2.8|0.88
91586169|NCT00710021|183063429|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586170|NCT00710021|183063430|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586171|NCT00710021|183063431|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586172|NCT00710021|183063432|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586173|NCT00710021|183063433|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586174|NCT00710021|183063434|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
91586175|NCT00710021|183063435|SUPERIORITY_OR_OTHER|||||||0.1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Cochran-Mantel-Haenszel|Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.||||||0.10
91586176|NCT01992393|183063449|OTHER|||||||0.036|||||||GEE|||||||0.036
91586177|NCT01992393|183063450|OTHER|||||||0.042|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.042
91586178|NCT01992393|183063450|OTHER|||||||0.204|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU||||0.204
91586179|NCT01992393|183063451|OTHER|||||||0.129|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.129
91586180|NCT01992393|183063451|OTHER|||||||0.978|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.978
91586181|NCT01992393|183063452|OTHER|||||||0.128|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.128
91586182|NCT01992393|183063452|OTHER|||||||0.015|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.015
91586183|NCT01992393|183063453|OTHER|||||||0.759|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.759
91586184|NCT01992393|183063453|OTHER|||||||0.471|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.471
91586185|NCT01992393|183063454|OTHER|||||||0.775|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.775
91586186|NCT01992393|183063454|OTHER|||||||0.433|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.433
91586187|NCT01992393|183063455|OTHER|||||||0.936|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.936
91586188|NCT01992393|183063455|OTHER|||||||0.6|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.600
91586189|NCT01992393|183063456|OTHER|||||||0.56|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.560
91586190|NCT01992393|183063456|OTHER|||||||0.305|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.305
91586191|NCT05741372|183063457|OTHER||Adjusted geometric mean ratio|127.2|||||TWO_SIDED|90.0|85.4|189.6|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 23.6%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||189.6|85.4|
91586192|NCT05741372|183063457|OTHER||Adjusted geometric mean ratio|745.7|||||TWO_SIDED|90.0|464.9|1196.0|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 28.1%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||1196|464.9|
91586193|NCT05741372|183063458|OTHER||Adjusted geometric mean ratio|183.6|||||TWO_SIDED|90.0|117.3|287.5|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 26.6%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||287.5|117.3|
91586194|NCT05741372|183063458|OTHER||Adjusted geometric mean ratio|1712.2|||||TWO_SIDED|90.0|1006.7|2912.2|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 31.7%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||2912.2|1006.7|
91586195|NCT05741372|183063459|OTHER||Adjusted geometric mean ratio|96.6|||||TWO_SIDED|90.0|81.0|115.3|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 10.3%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||115.3|81.0|
91586196|NCT05741372|183063459|OTHER||Adjusted geometric mean ratio|93.6|||||TWO_SIDED|90.0|75.9|115.3|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 12.2%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||115.3|75.9|
91586197|NCT05741372|183063460|OTHER||Adjusted geometric mean ratio|78.9|||||TWO_SIDED|90.0|63.8|97.5|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 12.5%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||97.5|63.8|
91647368|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.|||||1.0000
91586198|NCT05741372|183063460|OTHER||Adjusted geometric mean ratio|83.6|||||TWO_SIDED|90.0|65.0|107.5|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 14.8%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||107.5|65.0|
91647369|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.|||||0
91647370|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.|||||0
91647371|NCT02524665|183186492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
91647372|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|0.63||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 1.|||||0.5000
91647373|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 2.|||||0.5000
91647374|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.92||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 4.|||||1.0000
91647375|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
91586199|NCT05741372|183063461|OTHER||Adjusted geometric mean ratio|97.4|||||TWO_SIDED|90.0|83.2|114.0|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 9.2%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||114|83.2|
91586200|NCT05741372|183063461|OTHER||Adjusted geometric mean ratio|94.2|||||TWO_SIDED|90.0|78.2|113.5|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 10.9%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||113.5|78.2|
91647376|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.88||0.8125||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||0.8125
91647377|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.94||0.5742||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0.5742
91647378|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0.5000
91647379|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||0.2500
91647380|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.62||1||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 1.|||||1.0000
91647381|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 2.|||||0.7500
91647382|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.98||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 4.|||||0.7500
91647383|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.73||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 8.|||||0.2500
91647384|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.54||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 1.|||||0.2500
91647385|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 2.|||||0.7500
91708839|NCT02362425|183310817|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.61|TWO_SIDED|95.0|-10.3|15.2|||t-test, 2 sided|||||15.2|-10.3|0.61
91586201|NCT05741372|183063462|OTHER||Adjusted geometric mean ratio|87.3|||||TWO_SIDED|90.0|74.0|102.9|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 9.7%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||102.9|74.0|
91708840|NCT02362425|183310818|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.87|TWO_SIDED|95.0|-7.4|8.5|||t-test, 2 sided|||||8.5|-7.4|0.87
91586202|NCT05741372|183063462|OTHER||Adjusted geometric mean ratio|83.6|||||TWO_SIDED|90.0|68.8|101.7|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 11.5%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||101.7|68.8|
91586203|NCT05741372|183063463|OTHER||Adjusted geometric mean ratio|88.3|||||TWO_SIDED|90.0|71.6|108.8|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 12.2%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||108.8|71.6|
91586204|NCT05741372|183063463|OTHER||Adjusted geometric mean ratio|115.5|||||TWO_SIDED|90.0|90.2|148.0|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 14.5%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||148.0|90.2|
91647386|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|1.01||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 4.|||||0.2500
91708841|NCT02362425|183310819|SUPERIORITY||Mean Difference (Final Values)|-12.5||||0.28|TWO_SIDED|95.0|-38.9|13.9|||t-test, 2 sided|||||13.9|-38.9|0.28
91708842|NCT02688764|183310862|SUPERIORITY|||||||0.1465||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.1465
91708843|NCT02688764|183310865|SUPERIORITY|||||||0.0872||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects||||0.0872
91708844|NCT02688764|183310866|SUPERIORITY|||||||0.6207||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.6207
91708845|NCT02688764|183310866|SUPERIORITY|||||||0.3226||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.3226
91708846|NCT02688764|183310884|SUPERIORITY|||||||0.5682||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=2 years to \<6 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5682
91708847|NCT02688764|183310884|SUPERIORITY|||||||0.2271||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=6 years to \<12 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.2271
91708848|NCT02688764|183310884|SUPERIORITY|||||||0.022||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=12 years to \<=18 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0220
91708849|NCT02688764|183310885|SUPERIORITY|||||||0.0058||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline above Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0058
91708850|NCT02688764|183310885|SUPERIORITY|||||||0.5801||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline below or within Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5801
91708851|NCT02579382|183310886|SUPERIORITY||Least Squares Mean Difference|0.107||||0.227|TWO_SIDED|95.0|-0.067|0.282||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.282|-0.067|0.227
91586205|NCT05741372|183063464|OTHER||Adjusted geometric mean ratio|76.8|||||TWO_SIDED|90.0|61.1|96.6|||||Ratio \[%\]=(adjusted geometric mean Group 2/adjusted geometric mean Group 1)\*100. Total gCV = 13.4%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||96.6|61.1|
91586206|NCT05741372|183063464|OTHER||Adjusted geometric mean ratio|96.2|||||TWO_SIDED|90.0|73.4|126.1|||||Ratio \[%\]=(adjusted geometric mean Group 3/adjusted geometric mean Group 1)\*100. Total gCV = 15.9%.|The adjusted geometric means ratio based on ANOVA was calculated by using least square means, the 90% CI by using residual error from quantiles from t-distribution. These quantities were back-transformed to original scale.||126.1|73.4|
91586207|NCT04837040|183063465|SUPERIORITY||Odds Ratio (OR)|126.526|||<|0.0001|TWO_SIDED|95.0|13.733|999.999|||exact logistic regression model|||Treatment comparison of all participants receiving paltusotine versus placebo has been presented.||999.999|13.733|<0.0001
91586208|NCT04837040|183063466|SUPERIORITY||least squares means difference|-0.791|||<|0.0001|TWO_SIDED|95.0|-1.057|-0.525|||ANCOVA|||||-0.525|-1.057|<0.0001
91586209|NCT04837040|183063467|SUPERIORITY||Odds Ratio (OR)|16.609||||0.0003|TWO_SIDED|95.0|2.864|181.355|||exact logistic regression model|||Treatment comparison of all participants receiving paltusotine versus placebo has been presented.||181.355|2.864|0.0003
91586210|NCT04837040|183063468|SUPERIORITY||least square mean difference|-5.164||||0.0216|TWO_SIDED|95.0|-9.536|-0.792|||ANCOVA|||||-0.792|-9.536|0.0216
91586211|NCT00602667|183063476|OTHER||Hazard Ratio (HR)|4.99|||||TWO_SIDED|95.0|1.17|21.23||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||21.23|1.17|
91586212|NCT00602667|183063476|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.4|1.84||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.84|0.40|
91586213|NCT00602667|183063477|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|0.42|8.22||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||8.22|0.42|
91647387|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 8.|||||0.2500
91586214|NCT00602667|183063477|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.31|1.79||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.79|0.31|
91647388|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.|||||0.5000
91586215|NCT02739412|183063551|SUPERIORITY|Power calculations were not performed in this study.|||||<|0.01|||||||ANOVA|||This is an open label feasibility study to assess the efficacy and safety of a 4 week course of daily subcutaneous IL-2 injections to increase peripheral blood CD4 Tregs. Results are expressed as median, IQR and comparison were performed using one way or two-way ANOVA, followed by Tukey's multiple comparison test. For all comparisons, a p\< 0.05 was considered significant.||||< 0.01
91586216|NCT04647526|183063597|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0088|TWO_SIDED|95.0|0.55|0.92|||Log Rank|||||0.92|0.55|0.0088
91586217|NCT05497284|183063620|OTHER|Probability (LTP001 is better than placebo)|Slope|-2.6|STANDARD_DEVIATION|2.07|||TWO_SIDED|80.0|-6.9|1.3||Probability that LTP001 is better than placebo is 10.3%|Baysesian random slope model|Bayesian random slope model to assess the difference in reduction rate (slope) in years between the treatment group and placebo group.||||1.3|-6.9|
91586218|NCT03816891|183063630|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|9.73||0.0347|TWO_SIDED|95.0|-40.82|-1.6||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||||-1.60|-40.82|0.0347
91586219|NCT03816891|183063630|SUPERIORITY||LS Mean Difference|-41.7|STANDARD_ERROR_OF_MEAN|6.73|<|0.0001|TWO_SIDED|95.0|-54.9|-28.5||Estimated from ANCOVA model with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||||-28.5|-54.9|<0.0001
91586220|NCT03816891|183063630|SUPERIORITY||LS Mean Difference|-36.4|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|95.0|-49.6|23.3||Estimated from ANCOVA model with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||||23.3|-49.6|<0.0001
91586221|NCT03816891|183063630|SUPERIORITY||LS Mean Difference|-18.4|STANDARD_ERROR_OF_MEAN|6.72||0.0061|TWO_SIDED|95.0|-31.6|-5.3||Estimated from ANCOVA model with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||||-5.3|-31.6|0.0061
91586222|NCT03816891|183063631|SUPERIORITY||Odds Ratio (OR)|2.76||||0.1093|TWO_SIDED|95.0|0.81|9.44||Calculated from Cochran-Mantel-Haenszel (CMH) test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||||9.44|0.81|0.1093
91586223|NCT03816891|183063632|SUPERIORITY||LS Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|9.86||0.0325|TWO_SIDED|95.0|-41.62|-1.9||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||||-1.90|-41.62|0.0325
91586224|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|5.85||0.0657|TWO_SIDED|95.0|-22.85|0.75||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 1||0.75|-22.85|0.0657
91647389|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.|||||0
91647390|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.|||||0.5000
91586225|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|6.96||0.0595|TWO_SIDED|95.0|-27.48|0.56||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||0.56|-27.48|0.0595
91586226|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|7.5||0.0455|TWO_SIDED|95.0|-30.55|-0.33||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 3||-0.33|-30.55|0.0455
91586227|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.73||0.0305|TWO_SIDED|95.0|-37.11|-1.93||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||-1.93|-37.11|0.0305
91586228|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|9.01||0.0456|TWO_SIDED|95.0|-36.69|-0.38||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 5||-0.38|-36.69|0.0456
91521209|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3465|TWO_SIDED|95.0|-0.8|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||0.3|-0.8|0.3465
91586229|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-20.5|STANDARD_ERROR_OF_MEAN|8.73||0.0236|TWO_SIDED|95.0|-38.06|-2.88||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||-2.88|-38.06|0.0236
91586230|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-20.8|STANDARD_ERROR_OF_MEAN|9.75||0.0385|TWO_SIDED|95.0|-40.45|-1.15||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 7||-1.15|-40.45|0.0385
91586231|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|9.73||0.0347|TWO_SIDED|95.0|-40.82|-1.6||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||-1.60|-40.82|0.0347
91586232|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|9.3||0.0694|TWO_SIDED|95.0|-36.06|1.44||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 9||1.44|-36.06|0.0694
91647391|NCT02524665|183186493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.81||1||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
91647392|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||1.0000
91647393|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||0||95.0||||The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||0
91647394|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||0.5637
91647395|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||1.0000
91647396|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||0.4795||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||0.4795
91647397|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||1.0000
91647398|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.3173
91647399|NCT02524665|183186494|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.1573
91647400|NCT02989610|183186495|SUPERIORITY|Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
91647401|NCT02989610|183186496|NON_INFERIORITY|Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
91521210|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4285|TWO_SIDED|95.0|-0.3|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||0.7|-0.3|0.4285
91647402|NCT02989610|183186497|SUPERIORITY|||||||1|||||||t-test, 1 sided|Paired t-test.||"Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.~The p-value presented is calculated and does not represent the threshold. The statistical test used for this endpoint is single sided, and the observed difference was in the opposite direction of the tested difference, leading to a p-value that is equivalent to 1 within the significance of the statistical software used."||||1.0000
91586233|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|8.93||0.0621|TWO_SIDED|95.0|-35.08|0.9||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 10||0.90|-35.08|0.0621
91647403|NCT04179474|183186498|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.55|||||TWO_SIDED|90.0|96.21|115.79|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.79|96.21|
91586234|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|9.52||0.2619|TWO_SIDED|95.0|-30.0|8.37||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 11||8.37|-30.0|0.2619
91647404|NCT04179474|183186499|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.03|||||TWO_SIDED|90.0|89.55|123.19|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||123.19|89.55|
91647405|NCT04179474|183186500|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.38|||||TWO_SIDED|90.0|96.19|115.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.45|96.19|
91647406|NCT04179474|183186501|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|104.76|||||TWO_SIDED|90.0|89.68|122.38|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||122.38|89.68|
91708852|NCT02579382|183310886|SUPERIORITY||Least Squares Mean Difference|0.018||||0.84|TWO_SIDED|95.0|-0.156|0.191||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.191|-0.156|0.840
91586235|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|9.17||0.1344|TWO_SIDED|95.0|-32.48|4.5||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||4.50|-32.48|0.1344
91586236|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-18.2|STANDARD_ERROR_OF_MEAN|9.17||0.0533|TWO_SIDED|95.0|-36.71|0.27||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 13||0.27|-36.71|0.0533
91586237|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|9.7||0.0335|TWO_SIDED|95.0|-40.82|-1.74||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 14||-1.74|-40.82|0.0335
91586238|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-19.1|STANDARD_ERROR_OF_MEAN|9.65||0.0536|TWO_SIDED|95.0|-38.58|0.31||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 15||0.31|-38.58|0.0536
91586239|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-19.1|STANDARD_ERROR_OF_MEAN|8.95||0.0388|TWO_SIDED|95.0|-37.11|-1.03||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||-1.03|-37.11|0.0388
91586240|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|15.92||0.5181|TWO_SIDED|95.0|-43.94|22.95||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 17||22.95|-43.94|0.5181
91586241|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|15.3||0.4142|TWO_SIDED|95.0|-45.08|19.47||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 18||19.47|-45.08|0.4142
91586242|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|14.85||0.445|TWO_SIDED|95.0|-42.94|19.72||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 19||19.72|-42.94|0.4450
91586243|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|15.2||0.6897|TWO_SIDED|95.0|-38.23|25.89||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 20||25.89|-38.23|0.6897
91586244|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|15.66||0.5636|TWO_SIDED|95.0|-42.25|23.81||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 21||23.81|-42.25|0.5636
91586245|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|14.85||0.419|TWO_SIDED|95.0|-43.64|19.04||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 22||19.04|-43.64|0.4190
91586246|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|15.88||0.3818|TWO_SIDED|95.0|-47.76|19.24||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 23||19.24|-47.76|0.3818
91586247|NCT03816891|183063634|SUPERIORITY||LS Mean Difference|-17.9|STANDARD_ERROR_OF_MEAN|16.61||0.2957|TWO_SIDED|95.0|-52.97|17.13||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||17.13|-52.97|0.2957
91647407|NCT04179474|183186502|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|103.86|||||TWO_SIDED|90.0|93.01|115.98|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means||115.98|93.01|
91647408|NCT04179474|183186503|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|99.55|||||TWO_SIDED|90.0|82.27|120.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||120.45|82.27|
91708853|NCT02579382|183310886|SUPERIORITY||Least Squares Mean Difference|0.127||||0.151|TWO_SIDED|95.0|-0.047|0.301||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.301|-0.047|0.151
91586248|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|7.64||0.7379|TWO_SIDED|95.0|-17.98|12.83||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 1||12.83|-17.98|0.7379
91708854|NCT03026283|183310909|OTHER|||||||1||||||In order to evaluate the significance of sensitivity and specificity findings, we implement McNemar's test comparing sensitivity and specificity for CCTA alone and FFR-CT, assuming conditional dependence.|Chi-squared|||Reference test is positive (test of sensitivity).||||1.00
91586249|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|9.45||0.3022|TWO_SIDED|95.0|-28.9|9.17||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||9.17|-28.90|0.3022
91586250|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|9.15||0.0606|TWO_SIDED|95.0|-36.07|0.82||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 3||0.82|-36.07|0.0606
91586251|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|10.65||0.1448|TWO_SIDED|95.0|-37.28|5.66||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||5.66|-37.28|0.1448
91586252|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|9.65||0.048|TWO_SIDED|95.0|-39.06|-0.18||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 5||-0.18|-39.06|0.0480
91586253|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-18.2|STANDARD_ERROR_OF_MEAN|10.95||0.1032|TWO_SIDED|95.0|-40.3|3.85||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||3.85|-40.30|0.1032
91586254|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-20.7|STANDARD_ERROR_OF_MEAN|10.39||0.0523|TWO_SIDED|95.0|-41.66|0.22||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 7||0.22|-41.66|0.0523
91586255|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|9.86||0.0325|TWO_SIDED|95.0|-41.62|-1.9||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||-1.90|-41.62|0.0325
91586256|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|13.13||0.7274|TWO_SIDED|95.0|-22.83|32.12||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 9||32.12|-22.83|0.7274
91779448|NCT01746901|183439332|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0039|TWO_SIDED|95.0|6.1|31.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.0|6.1|0.0039
91779449|NCT01746901|183439332|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|||<|0.0001|TWO_SIDED|95.0|23.6|48.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.5|23.6|<0.0001
91779450|NCT01746901|183439332|SUPERIORITY_OR_OTHER||LS Mean Difference|15.4||||0.0157|TWO_SIDED|95.0|2.9|27.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.8|2.9|0.0157
91779451|NCT01746901|183439332|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
91779452|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|||<|0.0001|TWO_SIDED|95.0|6.4|18.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|6.4|<0.0001
91779453|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.255|TWO_SIDED|95.0|-2.6|9.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||9.6|-2.6|0.2550
91779454|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4||||0.001|TWO_SIDED|95.0|4.3|16.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|4.3|0.0010
91779455|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|5.7||||0.0667|TWO_SIDED|95.0|-0.4|11.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.8|-0.4|0.0667
91779456|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|8.3||||0.0075|TWO_SIDED|95.0|2.3|14.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|2.3|0.0075
91779457|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.1354|TWO_SIDED|95.0|-1.5|10.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.7|-1.5|0.1354
91779458|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|50.9|||<|0.0001|TWO_SIDED|95.0|34.2|67.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.5|34.2|<0.0001
91779459|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3905|TWO_SIDED|95.0|-9.4|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|-9.4|0.3905
91779460|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|28.6||||0.0009|TWO_SIDED|95.0|11.9|45.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|11.9|0.0009
91586257|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|9.63||0.1523|TWO_SIDED|95.0|-33.47|5.39||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 10||5.39|-33.47|0.1523
91586258|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|14.61||0.9649|TWO_SIDED|95.0|-29.93|31.24||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 11||31.24|-29.93|0.9649
91779461|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|29.6||||0.0006|TWO_SIDED|95.0|12.9|46.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.3|12.9|0.0006
91586259|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|8.61||0.1351|TWO_SIDED|95.0|-30.48|4.25||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||4.25|-30.48|0.1351
91779462|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0072|TWO_SIDED|95.0|6.3|39.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.5|6.3|0.0072
91779463|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0||||0.0035|TWO_SIDED|95.0|8.4|41.6|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||41.6|8.4|0.0035
91779464|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|248.4|||<|0.0001|TWO_SIDED|95.0|188.6|308.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||308.3|188.6|<0.0001
91779465|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|68.2||||0.0263|TWO_SIDED|95.0|8.2|128.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||128.2|8.2|0.0263
91779466|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|151.2|||<|0.0001|TWO_SIDED|95.0|91.3|211.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||211.1|91.3|<0.0001
91586260|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|15.01||0.7258|TWO_SIDED|95.0|-36.75|26.07||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 13||26.07|-36.75|0.7258
91586261|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|14.14||0.6646|TWO_SIDED|95.0|-35.81|23.36||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 14||23.36|-35.81|0.6646
91586262|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|14.71||0.9151|TWO_SIDED|95.0|-29.2|32.38||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 15||32.38|-29.20|0.9151
91647409|NCT04508621|183186534|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.115|TWO_SIDED|95.0|-0.6|0.1|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||0.1|-0.6|0.115
91586263|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-20.9|STANDARD_ERROR_OF_MEAN|9.32||0.0304|TWO_SIDED|95.0|-39.66|-2.07||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||-2.07|-39.66|0.0304
91779467|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|165.4|||<|0.0001|TWO_SIDED|95.0|105.6|225.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.3|105.6|<0.0001
91779468|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|97.9||||0.0015|TWO_SIDED|95.0|38.3|157.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||157.6|38.3|0.0015
91779469|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|138.4|||<|0.0001|TWO_SIDED|95.0|78.7|198.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.2|78.7|<0.0001
91779470|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|241.3|||<|0.0001|TWO_SIDED|95.0|162.8|319.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||319.9|162.8|<0.0001
91779471|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|121.1||||0.0028|TWO_SIDED|95.0|42.4|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|42.4|0.0028
91779472|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|164.4|||<|0.0001|TWO_SIDED|95.0|85.8|243.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.1|85.8|<0.0001
91779473|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|198.0|||<|0.0001|TWO_SIDED|95.0|119.4|276.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||276.6|119.4|<0.0001
91779474|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|111.1||||0.0057|TWO_SIDED|95.0|32.8|189.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.4|32.8|0.0057
91779475|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|168.1|||<|0.0001|TWO_SIDED|95.0|89.7|246.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|89.7|<0.0001
91779476|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|128.4||||0.036|TWO_SIDED|95.0|8.5|248.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||248.3|8.5|0.0360
91779477|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|221.5||||0.0004|TWO_SIDED|95.0|101.2|341.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||341.7|101.2|0.0004
91779478|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0388|TWO_SIDED|95.0|6.6|246.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.8|6.6|0.0388
91586264|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|16.62||0.5209|TWO_SIDED|95.0|-45.96|24.17||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 18||24.17|-45.96|0.5209
91779479|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|223.2||||0.0003|TWO_SIDED|95.0|103.2|343.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.2|103.2|0.0003
91779480|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|107.2||||0.0787|TWO_SIDED|95.0|-12.4|226.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||226.8|-12.4|0.0787
91779481|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|181.3||||0.0033|TWO_SIDED|95.0|61.5|301.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.0|61.5|0.0033
91779482|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1||||0.1688|TWO_SIDED|95.0|-41.2|233.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||233.3|-41.2|0.1688
91779483|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|220.3||||0.0019|TWO_SIDED|95.0|82.6|358.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||358.0|82.6|0.0019
91779484|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|106.0||||0.1298|TWO_SIDED|95.0|-31.5|243.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.5|-31.5|0.1298
91779485|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|210.4||||0.0029|TWO_SIDED|95.0|73.0|347.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.8|73.0|0.0029
91779486|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|108.7||||0.1189|TWO_SIDED|95.0|-28.3|245.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||245.7|-28.3|0.1189
91708855|NCT03026283|183310909|OTHER||||||<|0.0047||||||In order to evaluate the significance of sensitivity and specificity findings, we implement Mcnemar's test comparing sensitive and pscificity for CCTA and FFR-CT assuming dependence.|Chi-squared|McNemar's chi-squared = 8.00||Reference test is Negative||||<0.0047
91779487|NCT01746901|183439333|SUPERIORITY_OR_OTHER||LS Mean Difference|153.6||||0.0284|TWO_SIDED|95.0|16.4|290.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.8|16.4|0.0284
91779488|NCT01746901|183439334|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0327|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.1|-3.4|0.0327
91779489|NCT01746901|183439334|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0019|TWO_SIDED|95.0|1.0|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.0|0.0019
91779490|NCT01746901|183439334|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7508|TWO_SIDED|95.0|-1.9|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.9|0.7508
91779491|NCT01746901|183439334|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.1868|TWO_SIDED|95.0|-0.5|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-0.5|0.1868
91779492|NCT01746901|183439334|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-1.6|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-1.6|0.9944
91779493|NCT01746901|183439334|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.2322|TWO_SIDED|95.0|-0.6|2.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.6|-0.6|0.2322
91779494|NCT01746901|183439335|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|||<|0.0001|TWO_SIDED|95.0|16.8|39.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.6|16.8|<0.0001
91779495|NCT01746901|183439335|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.1421|TWO_SIDED|95.0|-2.8|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|-2.8|0.1421
91779496|NCT01746901|183439335|SUPERIORITY_OR_OTHER||LS Mean Difference|20.9||||0.0004|TWO_SIDED|95.0|9.5|32.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.2|9.5|0.0004
91779497|NCT01746901|183439335|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0064|TWO_SIDED|95.0|4.5|27.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.0|4.5|0.0064
91779498|NCT01746901|183439335|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4||||0.1974|TWO_SIDED|95.0|-3.9|18.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|-3.9|0.1974
91779499|NCT01746901|183439335|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5||||0.0008|TWO_SIDED|95.0|8.3|30.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.8|8.3|0.0008
91779500|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|7.1|<0.0001
91779501|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.6868|TWO_SIDED|95.0|-4.1|6.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.2|-4.1|0.6868
91779502|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0058|TWO_SIDED|95.0|2.2|12.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.5|2.2|0.0058
91779503|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9||||0.0229|TWO_SIDED|95.0|0.8|11.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|0.8|0.0229
91779504|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.2168|TWO_SIDED|95.0|-1.9|8.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.3|-1.9|0.2168
91779505|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.0096|TWO_SIDED|95.0|1.7|11.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.9|1.7|0.0096
91779506|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|||<|0.0001|TWO_SIDED|95.0|20.0|45.9|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.9|20.0|<0.0001
91779507|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.8009|TWO_SIDED|95.0|-11.2|14.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|-11.2|0.8009
91779508|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|17.4||||0.0086|TWO_SIDED|95.0|4.5|30.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.3|4.5|0.0086
91779509|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2||||0.0089|TWO_SIDED|95.0|4.4|30.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.0|4.4|0.0089
91586265|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|17.93||0.5254|TWO_SIDED|95.0|-49.46|26.2||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 20||26.20|-49.46|0.5254
91586266|NCT03816891|183063636|SUPERIORITY||LS Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|17.7||0.4458|TWO_SIDED|95.0|-51.16|23.53||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||23.53|-51.16|0.4458
91586267|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|5.33||0.0149|TWO_SIDED|95.0|-24.22|-2.76||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||-2.76|-24.22|0.0149
91586268|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|6.73||0.1399|TWO_SIDED|95.0|-23.67|3.44||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||3.44|-23.67|0.1399
91586269|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|6.47||0.1078|TWO_SIDED|95.0|-23.68|2.42||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||2.42|-23.68|0.1078
91586270|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|7.02||0.0798|TWO_SIDED|95.0|-26.72|1.56||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||1.56|-26.72|0.0798
91586271|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|6.49||0.1405|TWO_SIDED|95.0|-22.83|3.34||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 10||3.34|-22.83|0.1405
91586272|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|6.77||0.2026|TWO_SIDED|95.0|-22.43|4.9||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||4.90|-22.43|0.2026
91586273|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|9.77||0.3646|TWO_SIDED|95.0|-29.52|11.37||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 14||11.37|-29.52|0.3646
91586274|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|6.45||0.1106|TWO_SIDED|95.0|-23.52|2.5||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||2.50|-23.52|0.1106
91586275|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-12.5|STANDARD_ERROR_OF_MEAN|10.74||0.2623|TWO_SIDED|95.0|-35.11|10.2||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 18||10.20|-35.11|0.2623
91586276|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|11.21||0.2095|TWO_SIDED|95.0|-38.27|9.03||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 20||9.03|-38.27|0.2095
91586277|NCT03816891|183063638|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|12.43||0.2127|TWO_SIDED|95.0|-42.3|10.13||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||10.13|-42.30|0.2127
91586278|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.96||||0.2474|TWO_SIDED|95.0|0.43|20.56||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 1||20.56|0.43|0.2474
91586279|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0687|TWO_SIDED|95.0|0.83|24.27||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 2||24.27|0.83|0.0687
91779510|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.4224|TWO_SIDED|95.0|-7.6|18.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-7.6|0.4224
91779511|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6||||0.0006|TWO_SIDED|95.0|9.8|35.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.5|9.8|0.0006
91779512|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1|||<|0.0001|TWO_SIDED|95.0|57.9|134.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||134.2|57.9|<0.0001
91779513|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|21.9||||0.253|TWO_SIDED|95.0|-15.8|59.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.7|-15.8|0.2530
91779514|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|78.6|||<|0.0001|TWO_SIDED|95.0|40.5|116.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||116.8|40.5|<0.0001
91779515|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|39.3||||0.0414|TWO_SIDED|95.0|1.6|77.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||77.1|1.6|0.0414
91779516|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9||||0.1329|TWO_SIDED|95.0|-8.9|66.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.6|-8.9|0.1329
91779517|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|45.5||||0.0187|TWO_SIDED|95.0|7.7|83.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|7.7|0.0187
91779518|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|76.9||||0.0009|TWO_SIDED|95.0|31.9|121.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.9|31.9|0.0009
91779519|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|45.4||||0.0456|TWO_SIDED|95.0|0.9|89.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.9|0.9|0.0456
91779520|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|82.8||||0.0004|TWO_SIDED|95.0|37.8|127.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||127.7|37.8|0.0004
91779521|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|39.6||||0.0812|TWO_SIDED|95.0|-5.0|84.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.1|-5.0|0.0812
91586280|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|6.89||||0.0145|TWO_SIDED|95.0|1.38|34.48||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 3||34.48|1.38|0.0145
91586281|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|4.85||||0.0235|TWO_SIDED|95.0|1.24|18.89||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 4||18.89|1.24|0.0235
91779522|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|35.5||||0.1174|TWO_SIDED|95.0|-9.0|80.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.0|-9.0|0.1174
91779523|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1||||0.0427|TWO_SIDED|95.0|1.5|90.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.6|1.5|0.0427
91779524|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0||||0.9318|TWO_SIDED|95.0|-66.9|73.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.0|-66.9|0.9318
91586282|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0334|TWO_SIDED|95.0|1.09|13.26||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 5||13.26|1.09|0.0334
91586283|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0618|TWO_SIDED|95.0|0.95|11.32||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 6||11.32|0.95|0.0618
91586284|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.38||||0.1748|TWO_SIDED|95.0|0.7|8.15||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 7||8.15|0.70|0.1748
91586285|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.76||||0.1093|TWO_SIDED|95.0|0.81|9.44||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 8||9.44|0.81|0.1093
91586286|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.76||||0.1093|TWO_SIDED|95.0|0.81|9.44||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 9||9.44|0.81|0.1093
91708856|NCT04560868|183310924|EQUIVALENCE|The point null hypothesis was a difference in expected number of log ins of exactly 0.|Mean Difference (Final Values)|12.73|||<|0.01|TWO_SIDED|95.0|6.41|19.05|||Regression, Linear||mean difference=experimental-control|Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.||19.05|6.41|<0.01
91586287|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.01||||0.261|TWO_SIDED|95.0|0.6|6.8||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 10||6.80|0.60|0.2610
91586288|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2867|TWO_SIDED|95.0|0.59|5.71||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 11||5.71|0.59|0.2867
91586289|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2874|TWO_SIDED|95.0|0.59|6.01||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 12||6.01|0.59|0.2874
91586290|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0527|TWO_SIDED|95.0|0.94|10.05||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 13||10.05|0.94|0.0527
91586291|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0936|TWO_SIDED|95.0|0.82|8.73||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 14||8.73|0.82|0.0936
91586292|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.92||||0.083|TWO_SIDED|95.0|0.84|10.21||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 15||10.21|0.84|0.0830
91586293|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3786|TWO_SIDED|95.0|0.53|5.33||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 16||5.33|0.53|0.3786
91586294|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6949|TWO_SIDED|95.0|0.12|3.99||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 17||3.99|0.12|0.6949
91586295|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|1.81||||0.5288|TWO_SIDED|95.0|0.31|10.66||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 18||10.66|0.31|0.5288
91586296|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|3.18||||0.2613|TWO_SIDED|95.0|0.43|23.37||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 19||23.37|0.43|0.2613
91708857|NCT04560868|183310925|EQUIVALENCE|The null hypothesis was a point null of relative risk equal to exactly 1.|Risk Ratio (RR)|1.01||||0.98|TWO_SIDED|95.0|0.55|1.85|||Regression, Poisson||relative risk=experimental/control|Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.||1.85|0.55|0.98
91708858|NCT04560868|183310926|EQUIVALENCE|The null hypothesis was a point null of exactly 0 risk difference between arms.|Risk Difference (RD)|0.08||||0.35|TWO_SIDED|95.0|-0.08|0.24|||Regression, Linear||Risk difference = experimental - control.|Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.||0.24|-0.08|0.35
91586297|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.23||||0.4208|TWO_SIDED|95.0|0.34|14.81||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 20||14.81|0.34|0.4208
91586298|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|1.32||||0.7884|TWO_SIDED|95.0|0.2|8.76||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 21||8.76|0.20|0.7884
91586299|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.68||||0.2982|TWO_SIDED|95.0|0.45|16.04||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 22||16.04|0.45|0.2982
91586300|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|3.18||||0.2613|TWO_SIDED|95.0|0.43|23.37||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 23||23.37|0.43|0.2613
91586301|NCT03816891|183063639|SUPERIORITY||Odds Ratio (OR)|2.23||||0.4208|TWO_SIDED|95.0|0.34|14.81||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 24||14.81|0.34|0.4208
91708859|NCT04560868|183310927|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.26||||0.4|TWO_SIDED|95.0|-0.35|0.87|||Regression, Linear||mean difference=experimental-control|||0.87|-0.35|0.40
91708860|NCT04560868|183310928|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.68|0.6|||Regression, Linear||mean difference=experimental-control|||0.60|-0.68|0.90
91586302|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|13.65||0.5172|TWO_SIDED|95.0|-36.42|18.6||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 1||18.60|-36.42|0.5172
91708861|NCT04560868|183310929|EQUIVALENCE|The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.4|||Regression, Linear||mean difference=experimental-control|||1.4|-0.5|0.39
91708862|NCT04560868|183310930|EQUIVALENCE|The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.6||||0.11|TWO_SIDED|95.0|-0.1|1.3|||Regression, Linear||mean difference=experimental-control|||1.3|-0.1|0.11
91708863|NCT04560868|183310932|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.|Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED|95.0|1.72|6.65|||Regression, Linear||mean difference=experimental-control|||6.65|1.72|<0.01
91708864|NCT04560868|183310933|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.08||||0.96|TWO_SIDED|95.0|-1.02|1.18|||Regression, Linear||mean difference=experimental-control|||1.18|-1.02|0.96
91708865|NCT04560868|183310934|EQUIVALENCE|The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.|Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.55|0.66|||Regression, Linear||mean difference=experimental-control|||0.66|-1.55|0.31
91708866|NCT04560868|183310938|EQUIVALENCE|The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.|Risk Ratio (RR)|3.9||||0.06|TWO_SIDED|95.0|0.9|16.9|||Regression, Poisson||RR=experimental/control|||16.9|0.9|0.06
91586303|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|14.77||0.1228|TWO_SIDED|95.0|-53.02|6.53||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||6.53|-53.02|0.1228
91586304|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-27.6|STANDARD_ERROR_OF_MEAN|26.99||0.3129|TWO_SIDED|95.0|-81.95|26.84||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 3||26.84|-81.95|0.3129
91586305|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-19.2|STANDARD_ERROR_OF_MEAN|12.36||0.1277|TWO_SIDED|95.0|-44.11|5.72||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||5.72|-44.11|0.1277
91779525|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|110.4||||0.002|TWO_SIDED|95.0|41.2|179.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||179.6|41.2|0.0020
91779526|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|81.5||||0.0226|TWO_SIDED|95.0|11.6|151.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||151.4|11.6|0.0226
91779527|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|32.0||||0.3629|TWO_SIDED|95.0|-37.3|101.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.2|-37.3|0.3629
91779528|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|35.9||||0.3077|TWO_SIDED|95.0|-33.4|105.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||105.1|-33.4|0.3077
91779529|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|39.1||||0.2662|TWO_SIDED|95.0|-30.1|108.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||108.4|-30.1|0.2662
91779530|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.4||||0.7875|TWO_SIDED|95.0|-94.7|71.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.9|-94.7|0.7875
91779531|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|115.0||||0.0066|TWO_SIDED|95.0|32.6|197.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||197.4|32.6|0.0066
91779532|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|81.7||||0.054|TWO_SIDED|95.0|-1.4|164.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.9|-1.4|0.0540
91779533|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8||||0.6014|TWO_SIDED|95.0|-60.6|104.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||104.3|-60.6|0.6014
91779534|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1||||0.3885|TWO_SIDED|95.0|-46.3|118.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.5|-46.3|0.3885
91586306|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|12.36||0.0424|TWO_SIDED|95.0|-50.76|-0.92||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 5||-0.92|-50.76|0.0424
91586307|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|22.06||0.1465|TWO_SIDED|95.0|-77.08|11.85||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||11.85|-77.08|0.1465
91586308|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-28.2|STANDARD_ERROR_OF_MEAN|12.68||0.0316|TWO_SIDED|95.0|-53.71|-2.59||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 7||-2.59|-53.71|0.0316
91586309|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-26.3|STANDARD_ERROR_OF_MEAN|10.59||0.0169|TWO_SIDED|95.0|-47.63|-4.95||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||-4.95|-47.63|0.0169
91586310|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|16.1||0.6641|TWO_SIDED|95.0|-40.8|26.59||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 9||26.59|-40.80|0.6641
91586311|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|11.26||0.0199|TWO_SIDED|95.0|-49.94|-4.53||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 10||-4.53|-49.94|0.0199
91779535|NCT01746901|183439336|SUPERIORITY_OR_OTHER||LS Mean Difference|29.5||||0.4801|TWO_SIDED|95.0|-52.9|112.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||112.0|-52.9|0.4801
91779536|NCT01746901|183439337|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.5494|TWO_SIDED|95.0|-2.5|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-2.5|0.5494
91779537|NCT01746901|183439337|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0626|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.8|-0.1|0.0626
91779538|NCT01746901|183439337|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7216|TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-1.6|0.7216
91779539|NCT01746901|183439337|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.3647|TWO_SIDED|95.0|-1.0|2.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-1.0|0.3647
91708867|NCT04560868|183310939|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.|Risk Ratio (RR)|1.01||||0.99|TWO_SIDED|95.0|0.38|2.65|||Regression, Poisson||risk ratio=experimental/control|||2.65|0.38|0.99
91586312|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|17.96||0.698|TWO_SIDED|95.0|-44.67|30.51||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 11||30.51|-44.67|0.6980
91586313|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|10.7||0.1838|TWO_SIDED|95.0|-36.05|7.13||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||7.13|-36.05|0.1838
91586314|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|18.99||0.2078|TWO_SIDED|95.0|-64.5|14.98||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 13||14.98|-64.50|0.2078
91586315|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|17.95||0.409|TWO_SIDED|95.0|-52.72|22.41||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 14||22.41|-52.72|0.4090
91586316|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|21.54||0.558|TWO_SIDED|95.0|-57.92|32.23||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 15||32.23|-57.92|0.5580
91586317|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|12.43||0.0486|TWO_SIDED|95.0|-50.3|-0.16||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||-0.16|-50.30|0.0486
91586318|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|17.73||0.3613|TWO_SIDED|95.0|-54.06|20.78||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 18||20.78|-54.06|0.3613
91586319|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|20.93||0.7042|TWO_SIDED|95.0|-52.24|36.08||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 20||36.08|-52.24|0.7042
91586320|NCT03816891|183063641|SUPERIORITY||LS Mean Difference|-25.6|STANDARD_ERROR_OF_MEAN|27.27||0.3602|TWO_SIDED|95.0|-83.17|31.89||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||31.89|-83.17|0.3602
91586321|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.97||0.5896|TWO_SIDED|95.0|-17.83|10.26||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 1||10.26|-17.83|0.5896
91586322|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|7.75||0.8292|TWO_SIDED|95.0|-17.29|13.93||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||13.93|-17.29|0.8292
91586323|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|8.23||0.4852|TWO_SIDED|95.0|-22.39|10.8||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 3||10.80|-22.39|0.4852
91586324|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|9.34||0.3731|TWO_SIDED|95.0|-27.24|10.42||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||10.42|-27.24|0.3731
91586325|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|10.15||0.436|TWO_SIDED|95.0|-28.44|12.48||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 5||12.48|-28.44|0.4360
91586326|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|10.54||0.5655|TWO_SIDED|95.0|-27.36|15.15||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||15.15|-27.36|0.5655
91586327|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|10.77||0.6302|TWO_SIDED|95.0|-26.93|16.49||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 7||16.49|-26.93|0.6302
91586328|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|10.89||0.5671|TWO_SIDED|95.0|-28.23|15.67||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||15.67|-28.23|0.5671
91586329|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|10.86||0.935|TWO_SIDED|95.0|-22.93|29.83||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 9||29.83|-22.93|0.935
91586330|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|10.08||0.9982|TWO_SIDED|95.0|-20.3|20.34||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 10||20.34|-20.30|0.9982
91586331|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|10.42||0.8102|TWO_SIDED|95.0|-18.48|23.51||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 11||23.51|-18.48|0.8102
91586332|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|10.34||0.9334|TWO_SIDED|95.0|-21.7|19.97||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||19.97|-21.70|0.9334
91586333|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|9.73||0.5873|TWO_SIDED|95.0|-24.92|14.29||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 13||14.29|-24.92|0.5873
91586334|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|9.82||0.3737|TWO_SIDED|95.0|-28.61|10.96||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 14||10.96|-28.61|0.3737
91586335|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|9.78||0.3631|TWO_SIDED|95.0|-28.7|10.72||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 15||10.72|-28.70|0.3631
91586336|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|10.06||0.5585|TWO_SIDED|95.0|-26.2|14.34||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||14.34|-26.20|0.5585
91586337|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|17.65||0.8889|TWO_SIDED|95.0|-39.58|34.58||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 17||34.58|-39.58|0.8889
91586338|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|17.15||0.7099|TWO_SIDED|95.0|-42.67|29.7||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 18||29.70|-42.67|0.7099
91586339|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|17.2||0.727|TWO_SIDED|95.0|-42.4|30.19||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 19||30.19|-42.40|0.7270
91586340|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|17.45||0.8366|TWO_SIDED|95.0|-40.47|33.16||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 20||33.16|-40.47|0.8366
91586341|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|18.17||0.8013|TWO_SIDED|95.0|-42.99|33.69||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 21||33.69|-42.99|0.8013
91647410|NCT04508621|183186535|SUPERIORITY|Patients with missing data considered non-responders.|Difference in Proportions|8.0||||0.038|TWO_SIDED|95.0|0.5|15.5|||Pearson Chi-Squared|||||15.5|0.5|0.038
91521211|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6703|TWO_SIDED|95.0|-0.4|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||0.6|-0.4|0.6703
91586342|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|17.23||0.681|TWO_SIDED|95.0|-43.56|29.15||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 22||29.15|-43.56|0.6810
91586343|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|17.69||0.8347|TWO_SIDED|95.0|-41.08|33.58||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 23||33.58|-41.08|0.8347
91586344|NCT03816891|183063643|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|17.42||0.9358|TWO_SIDED|95.0|-38.18|35.33||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||35.33|-38.18|0.9358
91586345|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|8.08||0.8948|TWO_SIDED|95.0|-15.2|17.35||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week. Program:|ANCOVA|||Week 1||17.35|-15.20|0.8948
91586346|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.55||0.8581|TWO_SIDED|95.0|-16.58|13.86||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||13.86|-16.58|0.8581
91586347|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|8.02||0.2797|TWO_SIDED|95.0|-24.93|7.38||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 3||7.38|-24.93|0.2797
91647411|NCT04508621|183186536|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.55||0.03|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||-0.3|-6.4|0.030
91586348|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|9.5||0.4333|TWO_SIDED|95.0|-26.67|11.64||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||11.64|-26.67|0.4333
91586349|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|9.77||0.2774|TWO_SIDED|95.0|-30.44|8.95||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 5||8.95|-30.44|0.2774
91586350|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|9.77||0.2308|TWO_SIDED|95.0|-31.55|7.82||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||7.82|-31.55|0.2308
91586351|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|9.99||0.1617|TWO_SIDED|95.0|-34.34|5.91||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 7||5.91|-34.34|0.1617
91708868|NCT04560868|183310940|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.|Mean Difference (Net)|1.39||||0.3|TWO_SIDED|95.0|-1.21|3.99|||Regression, Linear||treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.|||3.99|-1.21|0.30
91586352|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|10.16||0.222|TWO_SIDED|95.0|-33.05|7.89||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||7.89|-33.05|0.2220
91586353|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|10.15||0.6195|TWO_SIDED|95.0|-25.54|15.38||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 9||15.38|-25.54|0.6195
91586354|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|9.96||0.4984|TWO_SIDED|95.0|-26.86|13.27||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 10||13.27|-26.86|0.4984
91586355|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|10.11||0.8147|TWO_SIDED|95.0|-22.75|17.99||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 11||17.99|-22.75|0.8147
91586356|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|9.94||0.6917|TWO_SIDED|95.0|-24.01|16.07||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||16.07|-24.01|0.6917
91521212|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7187|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||0.5|-0.3|0.7187
91586357|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|10.34||0.7437|TWO_SIDED|95.0|-24.24|17.43||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 13||17.43|-24.24|0.7437
91708869|NCT04560868|183310941|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.|Mean Difference (Net)|1.5||||0.47|TWO_SIDED|95.0|-2.51|5.5|||Regression, Linear||treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.|||5.5|-2.51|0.47
91708870|NCT04560868|183310942|EQUIVALENCE|The null hypothesis was risk difference of exactly 0.|Risk Difference (RD)|0.04||||0.3|TWO_SIDED|95.0|-0.03|0.11|||Regression, Linear||risk difference=experimental-control|||0.11|-0.03|0.30
91708871|NCT01649362|183310943|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||||||0.63
91779540|NCT01746901|183439337|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.4456|TWO_SIDED|95.0|-2.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.7|0.4456
91779541|NCT01746901|183439337|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.05|TWO_SIDED|95.0|0.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|0.0|0.0500
91779542|NCT01746901|183439338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.34|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.34|-0.69|<0.0001
91779543|NCT01746901|183439338|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.86|-1.52|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.52|-1.86|<0.0001
91779544|NCT01746901|183439338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.63|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.63|-0.97|<0.0001
91779545|NCT01746901|183439338|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.58|-1.23|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.23|-1.58|<0.0001
91779546|NCT01746901|183439338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.56|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.56|-0.91|<0.0001
91779547|NCT01746901|183439338|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.46|-1.11|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.11|-1.46|<0.0001
91779548|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.75|-1.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.42|-1.75|<0.0001
91779549|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.3309|TWO_SIDED|95.0|-0.24|0.08|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.08|-0.24|0.3309
91779550|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.42|-0.74|<0.0001
91779551|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.92|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.92|-1.25|<0.0001
91779552|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.59|-0.26|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.26|-0.59|<0.0001
91779553|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.88|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.88|-1.21|<0.0001
91779554|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.03|||<|0.0001|TWO_SIDED|95.0|-4.37|-3.69|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.69|-4.37|<0.0001
91708872|NCT01649362|183310944|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
91708873|NCT01649362|183310945|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
91779555|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.2475|TWO_SIDED|95.0|-0.54|0.14|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.14|-0.54|0.2475
91779556|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.27|-1.96|<0.0001
91779557|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.62|||<|0.0001|TWO_SIDED|95.0|-2.96|-2.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.27|-2.96|<0.0001
91586358|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|11.34||0.7663|TWO_SIDED|95.0|-26.26|19.47||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 14||19.47|-26.26|0.7663
91586359|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|10.71||0.5157|TWO_SIDED|95.0|-28.61|14.75||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 15||14.75|-28.61|0.5157
91586360|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|10.41||0.5115|TWO_SIDED|95.0|-27.86|14.09||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||14.09|-27.86|0.5115
91586361|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|17.3||0.8795|TWO_SIDED|95.0|-33.68|39.0||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 17||39.00|-33.68|0.8795
91586362|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|17.11||0.9254|TWO_SIDED|95.0|-37.73|34.48||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 18||34.48|-37.73|0.9254
91586363|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|17.34||0.7718|TWO_SIDED|95.0|-41.68|31.47||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 19||31.47|-41.68|0.7718
91586364|NCT03816891|183063645|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|17.38||0.9855|TWO_SIDED|95.0|-36.34|36.98||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 20||36.98|-36.34|0.9855
91586365|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|18.21||0.7508|TWO_SIDED|95.0|-44.29|32.54||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 21||32.54|-44.29|0.7508
91586366|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|17.26||0.826|TWO_SIDED|95.0|-40.26|32.55||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 22||32.55|-40.26|0.8260
91521213|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.135|TWO_SIDED|95.0|-0.1|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.7|-0.1|0.1350
91586367|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|18.23||0.7259|TWO_SIDED|95.0|-44.95|31.96||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 23||31.96|-44.95|0.7259
91586368|NCT03816891|183063645|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|17.66||0.6826|TWO_SIDED|95.0|-44.61|29.92||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||29.92|-44.61|0.6826
91586369|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-28.0|STANDARD_ERROR_OF_MEAN|8.43||0.0018|TWO_SIDED|95.0|-44.96|-10.97||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||-10.97|-44.96|0.0018
91586370|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|8.2||0.0127|TWO_SIDED|95.0|-37.83|-4.77||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||-4.77|-37.83|0.0127
91586371|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|8.53||0.1547|TWO_SIDED|95.0|-29.54|4.84||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||4.84|-29.54|0.1547
91586372|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|9.62||0.2048|TWO_SIDED|95.0|-31.78|7.01||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||7.01|-31.78|0.2048
91586373|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|13.58||0.9508|TWO_SIDED|95.0|-29.28|27.58||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||27.58|-29.28|0.9508
91586374|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|8.74||0.614|TWO_SIDED|95.0|-22.07|13.19||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||13.19|-22.07|0.6140
91586375|NCT03816891|183063647|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|17.12||0.6207|TWO_SIDED|95.0|-44.94|27.66||from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||27.66|-44.94|0.6207
91586376|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|3.52||0.0079|TWO_SIDED|95.0|-16.89|-2.71||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 2||-2.71|-16.89|0.0079
91586377|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|5.12||0.0122|TWO_SIDED|95.0|-23.69|-3.06||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 4||-3.06|-23.69|0.0122
91586378|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|5.4||0.0328|TWO_SIDED|95.0|-22.8|-1.02||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 6||-1.02|-22.80|0.0328
91586379|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|5.76||0.0212|TWO_SIDED|95.0|-25.36|-2.15||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 8||-2.15|-25.36|0.0212
91586380|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|8.28||0.3112|TWO_SIDED|95.0|-25.95|8.72||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 12||8.72|-25.95|0.3112
91586381|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|5.74||0.0113|TWO_SIDED|95.0|-26.75|-3.61||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 16||-3.61|-26.75|0.0113
91586382|NCT03816891|183063649|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|10.11||0.454|TWO_SIDED|95.0|-29.2|13.68||Calculated from ANCOVA models including treatment as fixed effect, sex, atopy and baseline value as covariates by week.|ANCOVA|||Week 24||13.68|-29.20|0.4540
91586383|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|1.23||||0.8436|TWO_SIDED|95.0|0.16|9.64||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 2||9.64|0.16|0.8436
91586384|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|1.99||||0.4922|TWO_SIDED|95.0|0.29|13.75||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 4||13.75|0.29|0.4922
91586385|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|7.7||||0.0064|TWO_SIDED|95.0|1.61|36.91||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 6||36.91|1.61|0.0064
91710803|NCT02258217|183314016|EQUIVALENCE|"We created a difference in MSIS physical score variable. This was calculated as follows:~MSIS physical score (new relapse) - MSIS physical score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|2.5||||0.19|TWO_SIDED||||||Wilcoxon Signed Rank test|||"We compared the two MSIS physical scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post MSIS physical scores."||||0.19
91779558|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.00|-1.68|<0.0001
91779559|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.76|-2.08|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.08|-2.76|<0.0001
91779560|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.91|||<|0.0001|TWO_SIDED|95.0|-13.21|-10.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-10.60|-13.21|<0.0001
91779561|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|||<|0.0001|TWO_SIDED|95.0|-8.54|-5.93|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.93|-8.54|<0.0001
91586386|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|5.14||||0.0201|TWO_SIDED|95.0|1.26|20.91||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 8||20.91|1.26|0.0201
91586387|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0841|TWO_SIDED|95.0|0.82|10.55||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 10||10.55|0.82|0.0841
91586388|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|4.14||||0.0292|TWO_SIDED|95.0|1.12|15.22||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 12||15.22|1.12|0.0292
91586389|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|2.76||||0.2259|TWO_SIDED|95.0|0.51|15.0||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 14||15.00|0.51|0.2259
91586390|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0104|TWO_SIDED|95.0|1.41|20.95||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 16||20.95|1.41|0.0104
91586391|NCT03816891|183063653|OTHER||Odds Ratio (OR)|13.8||||0.0434|TWO_SIDED|95.0|0.89|214.44||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 18||214.44|0.89|0.0434
91586392|NCT03816891|183063653|SUPERIORITY|||||||0.0093||||||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 20||||0.0093
91586393|NCT03816891|183063653|SUPERIORITY||Odds Ratio (OR)|14.4||||0.029|TWO_SIDED|95.0|1.1|189.25||Calculated from CMH test with sex and atopy as stratification factors and placebo as reference within corresponding cohort.|Cochran-Mantel-Haenszel|||Week 24||189.25|1.10|0.0290
91779562|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.59|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-6.59|-9.20|<0.0001
91586394|NCT03816891|183063654|SUPERIORITY||Odds Ratio (OR)|71.24|||<|0.0001|TWO_SIDED|95.0|5.35|948.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||948.31|5.35|<0.0001
91586395|NCT03816891|183063654|SUPERIORITY||Odds Ratio (OR)|11.62||||0.0019|TWO_SIDED|95.0|1.62|83.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||83.47|1.62|0.0019
91586396|NCT03816891|183063654|SUPERIORITY||Odds Ratio (OR)|8.84||||0.0117|TWO_SIDED|95.0|1.14|68.26||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||68.26|1.14|0.0117
91586397|NCT03816891|183063655|SUPERIORITY||Odds Ratio (OR)|8.6|||<|0.0001|TWO_SIDED|95.0|3.34|22.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||22.14|3.34|<0.0001
91586398|NCT03816891|183063655|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|2.91|19.79||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||19.79|2.91|<0.0001
91586399|NCT03816891|183063655|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1252|TWO_SIDED|95.0|0.8|5.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||5.75|0.80|0.1252
91586400|NCT03816891|183063656|SUPERIORITY||Odds Ratio (OR)|5.65||||0.0017|TWO_SIDED|95.0|1.83|17.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||17.47|1.83|0.0017
91586401|NCT03816891|183063656|SUPERIORITY||Odds Ratio (OR)|3.61||||0.0196|TWO_SIDED|95.0|1.19|10.99||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||10.99|1.19|0.0196
91586402|NCT03816891|183063656|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6213|TWO_SIDED|95.0|0.4|4.69||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||||4.69|0.40|0.6213
91586403|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-1.8|-0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 1||-0.7|-1.8|<0.0001
91586404|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0287|TWO_SIDED|95.0|-1.2|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 1||-0.1|-1.2|0.0287
91586405|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.1123|TWO_SIDED|95.0|-1.0|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 1||0.1|-1.0|0.1123
91647412|NCT04508621|183186537|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.46||0.797|TWO_SIDED|95.0|-3.2|2.5|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||2.5|-3.2|0.797
91586406|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.0|-1.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-1.3|-3.0|<0.0001
91710804|NCT02258217|183314017|EQUIVALENCE|"We created a difference in MSIS psychological score variable. This was calculated as follows:~MSIS psychological score (new relapse) - MSIS psychological score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.3||0.01|TWO_SIDED|95.0|0.74|5.45|||Paired t-test, 2 sided|||"We compared the two MSIS psychological scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post MSIS psychological scores."||5.45|0.74|0.01
91586407|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0044|TWO_SIDED|95.0|-2.0|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-0.4|-2.0|0.0044
91586408|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0046|TWO_SIDED|95.0|-2.0|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-0.4|-2.0|0.0046
91586409|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.6|-1.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 3||-1.8|-3.6|<0.0001
91586410|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44||0.0011|TWO_SIDED|95.0|-2.3|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 3||-0.6|-2.3|0.0011
91586411|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.44||0.0171|TWO_SIDED|95.0|-1.9|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 3||-0.2|-1.9|0.0171
91779563|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.24|||<|0.0001|TWO_SIDED|95.0|-12.55|-9.94|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.94|-12.55|<0.0001
91779564|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.35|||<|0.0001|TWO_SIDED|95.0|-7.65|-5.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.05|-7.65|<0.0001
91779565|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.36|||<|0.0001|TWO_SIDED|95.0|-11.67|-9.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.05|-11.67|<0.0001
91779566|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.37|||<|0.0001|TWO_SIDED|95.0|-13.16|-9.58|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.58|-13.16|<0.0001
91779567|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.07|||<|0.0001|TWO_SIDED|95.0|-17.86|-14.28|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-14.28|-17.86|<0.0001
91779568|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.73|||<|0.0001|TWO_SIDED|95.0|-13.53|-9.93|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.93|-13.53|<0.0001
91779569|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.71|||<|0.0001|TWO_SIDED|95.0|-17.51|-13.91|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-13.91|-17.51|<0.0001
91779570|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.88|||<|0.0001|TWO_SIDED|95.0|-10.67|-7.09|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.09|-10.67|<0.0001
91779571|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.19|||<|0.0001|TWO_SIDED|95.0|-15.99|-12.39|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-12.39|-15.99|<0.0001
91779572|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.8784|TWO_SIDED|95.0|-3.63|3.11|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.11|-3.63|0.8784
91779573|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.66|||<|0.0001|TWO_SIDED|95.0|-45.02|-38.29|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-38.29|-45.02|<0.0001
91779574|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.63|||<|0.0001|TWO_SIDED|95.0|-23.01|-16.25|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-16.25|-23.01|<0.0001
91779575|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.28|||<|0.0001|TWO_SIDED|95.0|-25.67|-18.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.90|-25.67|<0.0001
91586412|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-4.0|-2.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-2.1|-4.0|<0.0001
91586413|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.6|-0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-0.8|-2.6|0.0002
91586414|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1146|TWO_SIDED|95.0|-1.6|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||0.2|-1.6|0.1146
91779576|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.5|||<|0.0001|TWO_SIDED|95.0|-15.86|-9.14|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.14|-15.86|<0.0001
91779577|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-23.98|-17.21|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.21|-23.98|<0.0001
91779578|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|10.64|||<|0.0001|TWO_SIDED|95.0|5.75|15.54|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.54|5.75|<0.0001
91779579|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.74|||<|0.0001|TWO_SIDED|95.0|-62.63|-52.85|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-52.85|-62.63|<0.0001
91779580|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.18|||<|0.0001|TWO_SIDED|95.0|-27.09|-17.27|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.27|-27.09|<0.0001
91586415|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-4.2|-2.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 5||-2.3|-4.2|<0.0001
91586416|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.0|-1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 5||-1.2|-3.0|<0.0001
91586417|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.46||0.0087|TWO_SIDED|95.0|-2.1|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 5||-0.3|-2.1|0.0087
91586418|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.3|-2.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 6||-2.4|-4.3|<0.0001
91586419|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.3|-1.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 6||-1.4|-3.3|<0.0001
91586420|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.47||0.0013|TWO_SIDED|95.0|-2.5|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 6||-0.6|-2.5|0.0013
91586421|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-4.4|-2.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 7||-2.4|-4.4|<0.0001
91586422|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-3.6|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 7||-1.6|-3.6|<0.0001
91586423|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.5||0.0048|TWO_SIDED|95.0|-2.4|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 7||-0.4|-2.4|0.0048
91586424|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.5|-2.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-2.4|-4.5|<0.0001
91586425|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-3.6|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-1.6|-3.6|<0.0001
91586426|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.51||0.0124|TWO_SIDED|95.0|-2.3|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-0.3|-2.3|0.0124
91586427|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-4.5|-2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 9||-2.5|-4.5|<0.0001
91586428|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-3.8|-1.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 9||-1.7|-3.8|<0.0001
91521214|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7046|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.5|-0.3|0.7046
91586429|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.52||0.0021|TWO_SIDED|95.0|-2.7|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 9||-0.6|-2.7|0.0021
91586430|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.6|-2.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 10||-2.4|-4.6|<0.0001
91586431|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.0|-1.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 10||-1.9|-4.0|<0.0001
91586432|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.54||0.0005|TWO_SIDED|95.0|-3.0|-0.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 10||-0.9|-3.0|0.0005
91586433|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.6|-2.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 11||-2.4|-4.6|<0.0001
91586434|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.1|-1.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 11||-1.8|-4.1|<0.0001
91586435|NCT03816891|183063657|OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.56||0.0044|TWO_SIDED|95.0|-2.7|-0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 11||-0.5|-2.7|0.0044
91586436|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.7|-2.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-2.4|-4.7|<0.0001
91586437|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-1.6|-3.8|<0.0001
91586438|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.56||0.0231|TWO_SIDED|95.0|-2.4|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-0.2|-2.4|0.0231
91586439|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.5|-2.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 13||-2.2|-4.5|<0.0001
91708874|NCT01704755|183311025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.||96.1|87.6|
91586440|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.0|-1.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 13||-1.7|-4.0|<0.0001
91586441|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.57||0.0074|TWO_SIDED|95.0|-2.7|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 13||-0.4|-2.7|0.0074
91586442|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-4.8|-2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 14||-2.5|-4.8|<0.0001
91586443|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-4.3|-2.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 14||-2.1|-4.3|<0.0001
91586444|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.58||0.0013|TWO_SIDED|95.0|-3.0|-0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 14||-0.7|-3.0|0.0013
91708875|NCT01704755|183311025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.||96.1|87.6|
91708876|NCT01704755|183311025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
91779581|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.91|||<|0.0001|TWO_SIDED|95.0|-29.83|-20.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-20.00|-29.83|<0.0001
91586445|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.8|-2.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 15||-2.6|-4.8|<0.0001
91586446|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.3|-2.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 15||-2.1|-4.3|<0.0001
91586447|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.57||0.001|TWO_SIDED|95.0|-3.0|-0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 15||-0.8|-3.0|0.0010
91586448|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.8|-2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-2.5|-4.8|<0.0001
91586449|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-4.2|-2.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-2.0|-4.2|<0.0001
91647413|NCT04508621|183186538|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.004|TWO_SIDED|95.0|-3.8|-0.7|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||-0.7|-3.8|0.004
91779582|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.53|||<|0.0001|TWO_SIDED|95.0|-18.41|-8.64|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-8.64|-18.41|<0.0001
91521215|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2765|TWO_SIDED|95.0|-0.2|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.6|-0.2|0.2765
91586450|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.57||0.004|TWO_SIDED|95.0|-2.8|-0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-0.5|-2.8|0.0040
91586451|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-4.2|-1.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 17||-1.9|-4.2|<0.0001
91647414|NCT04508621|183186539|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.74||0.101|TWO_SIDED|95.0|-2.7|0.2|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.2|-2.7|0.101
91647415|NCT04508621|183186540|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.094|TWO_SIDED|95.0|-0.6|0.0|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.0|-0.6|0.094
91708877|NCT01704755|183311025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
91708878|NCT01704755|183311026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|TWO_SIDED||||||Regression, Logistic|||To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.||||0.051
91708879|NCT01400906|183311029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.037|0.38|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.380|-0.037|
91708880|NCT01400906|183311029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||||TWO_SIDED|95.0|-0.047|0.37|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.370|-0.047|
91708881|NCT01400906|183311034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.638|||||TWO_SIDED|95.0|0.44|0.836|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.836|0.440|
91708882|NCT01400906|183311034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.661|||||TWO_SIDED|95.0|0.463|0.859|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.859|0.463|
91708883|NCT01400906|183311035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|0.018|0.333|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.333|0.018|
91708884|NCT01400906|183311035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|||||TWO_SIDED|95.0|0.008|0.323|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.323|0.008|
91586452|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.9|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 17||-1.6|-3.9|<0.0001
91586453|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.59||0.0087|TWO_SIDED|95.0|-2.7|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 17||-0.4|-2.7|0.0087
91586454|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.8|-1.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-1.4|-3.8|<0.0001
91586455|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.6||0.0003|TWO_SIDED|95.0|-3.4|-1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-1.0|-3.4|0.0003
91586456|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.59||0.359|TWO_SIDED|95.0|-2.4|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-0.1|-2.4|0.359
91586457|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6||0.0005|TWO_SIDED|95.0|-3.3|-0.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 19||-0.9|-3.3|0.0005
91586458|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.61||0.0027|TWO_SIDED|95.0|-3.1|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 19||-0.6|-3.1|0.0027
91586459|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.0657|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 19||0.1|-2.3|0.0657
91586460|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.6||0.0021|TWO_SIDED|95.0|-3.1|-0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-0.7|-3.1|0.0021
91586461|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.61||0.0172|TWO_SIDED|95.0|-2.7|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-0.3|-2.7|0.0172
91586462|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1344|TWO_SIDED|95.0|-2.1|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-0.3|-2.1|0.1344
91586463|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.61||0.0134|TWO_SIDED|95.0|-2.7|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 21||-0.3|-2.7|0.0134
91586464|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.62||0.026|TWO_SIDED|95.0|-2.6|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 21||-0.2|-2.6|0.0260
91586465|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.215|TWO_SIDED|95.0|-1.9|0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 21||0.4|-1.9|0.2150
91586466|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.62||0.0271|TWO_SIDED|95.0|-2.6|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 22||-0.2|-2.6|0.0271
91586467|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0502|TWO_SIDED|95.0|-2.5|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 22||0.0|-2.5|0.0502
91586468|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4138|TWO_SIDED|95.0|-1.7|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 22||0.7|-1.7|0.4138
91586469|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.63||0.0738|TWO_SIDED|95.0|-2.4|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 23||0.1|-2.4|0.0738
91586470|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63||0.1247|TWO_SIDED|95.0|-2.2|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 23||0.3|-2.2|0.1247
91779583|NCT01746901|183439339|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.7|||<|0.0001|TWO_SIDED|95.0|-28.62|-18.78|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.78|-28.62|<0.0001
91779584|NCT01746901|183439340|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|||<|0.0001|TWO_SIDED|95.0|-11.9|-7.57|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.57|-11.90|<0.0001
91779585|NCT01746901|183439340|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16|||<|0.0001|TWO_SIDED|95.0|2.99|7.32|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||7.32|2.99|<0.0001
91779586|NCT01746901|183439340|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.9766|TWO_SIDED|95.0|-2.13|2.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.20|-2.13|0.9766
91586471|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4572|TWO_SIDED|95.0|-1.7|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 23||0.8|-1.7|0.4572
91586472|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0617|TWO_SIDED|95.0|-2.4|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 24||0.1|-2.4|0.0617
91586473|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.63||0.677|TWO_SIDED|95.0|-2.4|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 24||0.1|-2.4|0.677
91779587|NCT01746901|183439340|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.44|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.44|-6.78|<0.0001
91779588|NCT01746901|183439340|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39||||0.7242|TWO_SIDED|95.0|-2.55|1.78|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.78|-2.55|0.7242
91586474|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4688|TWO_SIDED|95.0|-1.7|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 24||0.8|-1.7|0.4688
91586475|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1093|TWO_SIDED|95.0|-2.2|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 25||0.2|-2.2|0.1093
91586476|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1196|TWO_SIDED|95.0|-2.2|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 25||0.3|-2.2|0.1196
91779589|NCT01746901|183439340|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|||<|0.0001|TWO_SIDED|95.0|-6.62|-2.28|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.28|-6.62|<0.0001
91779590|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|19.0|||<|0.0001|TWO_SIDED|95.0|14.6|23.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.5|14.6|<0.0001
91779591|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.8048|TWO_SIDED|95.0|-3.9|5.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-3.9|0.8048
91779592|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.0002|TWO_SIDED|95.0|4.2|13.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.1|4.2|0.0002
91779593|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.4|6.5|<0.0001
91779594|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1||||0.0019|TWO_SIDED|95.0|2.7|11.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|2.7|0.0019
91779595|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6||||0.001|TWO_SIDED|95.0|3.2|12.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.1|3.2|0.0010
91779596|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|127.4|||<|0.0001|TWO_SIDED|95.0|93.6|161.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||161.2|93.6|<0.0001
91779597|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.7837|TWO_SIDED|95.0|-29.1|38.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-29.1|0.7837
91779598|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|65.8||||0.0002|TWO_SIDED|95.0|32.0|99.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||99.6|32.0|0.0002
91779599|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|66.3||||0.0002|TWO_SIDED|95.0|32.5|100.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|32.5|0.0002
91779600|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|60.3||||0.0006|TWO_SIDED|95.0|26.5|94.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.1|26.5|0.0006
91779601|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|31.9||||0.064|TWO_SIDED|95.0|-1.9|65.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.7|-1.9|0.0640
91586477|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.5763|TWO_SIDED|95.0|-1.5|0.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 25||0.9|-1.5|0.5763
91647416|NCT00752895|183186554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.295
91779602|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|142.6|||<|0.0001|TWO_SIDED|95.0|94.5|190.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||190.7|94.5|<0.0001
91779603|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.5169|TWO_SIDED|95.0|-32.3|63.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.9|-32.3|0.5169
91779604|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3||||0.0011|TWO_SIDED|95.0|33.2|129.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||129.3|33.2|0.0011
91779605|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|77.1||||0.0018|TWO_SIDED|95.0|29.1|125.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||125.2|29.1|0.0018
91586478|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0661|TWO_SIDED|95.0|-2.4|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 26||0.1|-2.4|0.0661
91586479|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0622|TWO_SIDED|95.0|-2.4|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 26||0.1|-2.4|0.0622
91586480|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4677|TWO_SIDED|95.0|-1.6|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 26||0.8|-1.6|0.4677
91586481|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.61||0.0854|TWO_SIDED|95.0|-2.2|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 27||0.1|-2.2|0.0854
91586482|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0768|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 27||0.1|-2.3|0.0768
91586483|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.256|TWO_SIDED|95.0|-1.9|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 27||0.5|-1.9|0.2560
91586484|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.61||0.0337|TWO_SIDED|95.0|-2.5|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 28||-0.1|-2.5|0.0337
91647417|NCT00752895|183186555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.820
91708885|NCT01400906|183311036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.476|||||TWO_SIDED|95.0|0.326|0.627|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.627|0.326|
91586485|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0778|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 28||0.1|-2.3|0.0778
91708886|NCT01400906|183311036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|0.38|0.68|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.680|0.380|
91586486|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.3218|TWO_SIDED|95.0|-1.8|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 28||0.6|-1.8|0.3218
91586487|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.59||0.0549|TWO_SIDED|95.0|-2.3|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 29||0.0|-2.3|0.0549
91586488|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0543|TWO_SIDED|95.0|-2.4|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 29||0.0|-2.4|0.0543
91586489|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3759|TWO_SIDED|95.0|-1.7|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 29||0.6|-1.7|0.3759
91708887|NCT02821416|183311038|SUPERIORITY||Median Difference (Final Values)|-5.81||||0.0208|TWO_SIDED|95.0|-10.69|-0.94|||Mixed Models Analysis|Model includes covariates of treatment, time post-allergen challenge , treatment\*time post-allergen challenge, allergen induced at screening||||-0.94|-10.69|0.0208
91708888|NCT02821416|183311039|SUPERIORITY||Median Difference (Final Values)|2.535||||0.363|TWO_SIDED|95.0|-3.045|8.116|||Mixed Models Analysis|Model includes covariates of treatment, maximum percent decrease in FEV1 late asthma response||||8.116|-3.045|0.3630
91708889|NCT01763203|183311041|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
91708890|NCT01763203|183311042|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
91708891|NCT01763203|183311044|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91708892|NCT01763203|183311045|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
91708893|NCT01763203|183311046|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
91708894|NCT01763203|183311047|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
91708895|NCT01763203|183311048|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
91708896|NCT01763203|183311049|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||||||0.47
91708897|NCT01763203|183311050|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
91708898|NCT01763203|183311051|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
91708899|NCT01763203|183311052|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||||||0.0021
91708900|NCT01763203|183311053|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
91708901|NCT01763203|183311054|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
91708902|NCT01763203|183311055|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
91708903|NCT01763203|183311056|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91708904|NCT01763203|183311057|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
91708905|NCT01763203|183311058|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
91708906|NCT01763203|183311059|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
91708907|NCT01763203|183311060|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
91708908|NCT02256917|183311061|OTHER|Confirmative one-sided one-sample Poisson-test.|ABR|4.87|||||TWO_SIDED|95.0|4.06|5.79||A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|one-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.96-5.93|||5.79|4.06|
91708909|NCT02256917|183311061|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Negative Binomial regression model including a correction for overdispersion.|Rate ratio|11.89|||<|0.0001|TWO_SIDED|95.0|7.5|18.86|||Negative binomial regression model|||||18.86|7.50|<0.0001
91708910|NCT02256917|183311061|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Poisson regression model including a correction for overdispersion.|Rate ratio|10.14|||<|0.0001|TWO_SIDED|95.0|6.12|16.8|||Poisson regression model|||||16.80|6.12|<0.0001
91708911|NCT02256917|183311062|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean spontaneous ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|3.12|||||TWO_SIDED|95.0|2.48|3.87|||One-sided one-sample Poisso|||||3.87|2.48|
91708912|NCT02256917|183311063|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with 2x/week prophylaxis or less with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|5.03|||||TWO_SIDED|95.0|3.9|6.39|||One-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.76-6.60|||6.39|3.90|
91779606|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|63.6||||0.0098|TWO_SIDED|95.0|15.6|111.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||111.7|15.6|0.0098
91779607|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|39.4||||0.1078|TWO_SIDED|95.0|-8.7|87.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||87.4|-8.7|0.1078
91708913|NCT01639703|183311082|OTHER||Odds Ratio (OR)|0.76||||0.2476|TWO_SIDED|95.0|0.47|1.21|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.21|0.47|0.2476
91708914|NCT01639703|183311083|OTHER||Odds Ratio (OR)|1.13||||0.5354|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.66|0.77|0.5354
91708915|NCT01639703|183311084|OTHER||Odds Ratio (OR)|0.9||||0.3487|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.13|0.71|0.3487
91779608|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|116.9|275.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||275.1|116.9|<0.0001
91779609|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.9726|TWO_SIDED|95.0|-77.7|80.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.5|-77.7|0.9726
91779610|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|114.1||||0.005|TWO_SIDED|95.0|35.0|193.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.2|35.0|0.0050
91779611|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|83.3||||0.0392|TWO_SIDED|95.0|4.2|162.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||162.4|4.2|0.0392
91779612|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|68.7||||0.0883|TWO_SIDED|95.0|-10.4|147.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.8|-10.4|0.0883
91779613|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|64.4||||0.11|TWO_SIDED|95.0|-14.7|143.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||143.5|-14.7|0.1100
91708916|NCT01639703|183311085|OTHER||Odds Ratio (OR)|1.08||||0.4195|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.29|0.90|0.4195
91708917|NCT01639703|183311086|OTHER||Odds Ratio (OR)|0.9||||0.7127|TWO_SIDED|95.0|0.53|1.54|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.54|0.53|0.7127
91708918|NCT01639703|183311087|OTHER||Odds Ratio (OR)|1.41||||0.1753|TWO_SIDED|95.0|0.86|2.31|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||2.31|0.86|0.1753
91708919|NCT01753115|183311108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of AUC|0.887|||||TWO_SIDED|90.0|0.831|0.948||||||Analysis of Ciprofloxacin Area Under the Curve at Day 5 and Day 44.||0.948|0.831|
91708920|NCT01753115|183311108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of Cmax|0.944|||||TWO_SIDED|90.0|0.852|1.046||||||Analysis of Cmax at Day 5 and Day 44||1.046|0.852|
91708921|NCT01753115|183311109|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.67.|Ratio of GMT|1.267|||||TWO_SIDED|95.0|0.898|1.787||||||||1.787|0.898|
91708922|NCT02081001|183311169|SUPERIORITY_OR_OTHER||Point estimate ratio|2.06|STANDARD_ERROR_OF_MEAN|1.19||0.23|TWO_SIDED|90.0|0.74|5.75|||Mixed Models Analysis|||||5.75|0.74|0.23
91708923|NCT02081001|183311169|SUPERIORITY_OR_OTHER||Point estimate ratio|1.25|STANDARD_ERROR_OF_MEAN|0.43||0.52|TWO_SIDED|90.0|0.69|2.28|||Mixed Models Analysis|||||2.28|0.69|0.52
91708924|NCT02081001|183311169|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.19||0.49|TWO_SIDED|90.0|0.59|1.25|||Mixed Models Analysis|||||1.25|0.59|0.49
91708925|NCT02081001|183311170|SUPERIORITY_OR_OTHER||Point estimate ratio|1.37|STANDARD_ERROR_OF_MEAN|0.34||0.23|TWO_SIDED|90.0|0.88|2.12|||Mixed Models Analysis|||||2.12|0.88|0.23
91779614|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|242.9|||<|0.0001|TWO_SIDED|95.0|138.6|347.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.2|138.6|<0.0001
91586490|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.6||0.0286|TWO_SIDED|95.0|-2.5|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 30||-0.1|-2.5|0.0286
91586491|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.61||0.0477|TWO_SIDED|95.0|-2.4|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 30||0.0|-2.4|0.0477
91586492|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2699|TWO_SIDED|95.0|-1.8|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 30||0.5|-1.8|0.2699
91586493|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.6||0.0294|TWO_SIDED|95.0|-2.5|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 31||-0.1|-2.5|0.0294
91586494|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.0702|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 31||0.1|-2.3|0.0702
91586495|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3636|TWO_SIDED|95.0|-1.7|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 31||0.6|-1.7|0.3636
91586496|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0273|TWO_SIDED|95.0|-2.5|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||-0.1|-2.5|0.0273
91708926|NCT02081001|183311170|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.18||0.09|TWO_SIDED|90.0|1.01|1.65|||Mixed Models Analysis|||||1.65|1.01|0.09
91779615|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.0||||0.6906|TWO_SIDED|95.0|-125.3|83.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|-125.3|0.6906
91586497|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.59||0.0785|TWO_SIDED|95.0|-2.2|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||0.1|-2.2|0.0785
91586498|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4111|TWO_SIDED|95.0|-1.6|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||0.7|-1.6|0.4111
91586499|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0471|TWO_SIDED|95.0|-2.4|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 33||0.0|-2.4|0.0471
91586500|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.59||0.0891|TWO_SIDED|95.0|-2.2|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 33||0.2|-2.2|0.0891
91586501|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.482|TWO_SIDED|95.0|-1.6|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 33||0.7|-1.6|0.4820
91586502|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0222|TWO_SIDED|95.0|-2.6|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 34||-0.2|-2.6|0.0222
91586503|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.0682|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 34||0.1|-2.3|0.0682
91586504|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4112|TWO_SIDED|95.0|-1.7|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 34||0.7|-1.7|0.4112
91586505|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.6||0.0307|TWO_SIDED|95.0|-2.5|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 35||-0.1|-2.5|0.0307
91586506|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1538|TWO_SIDED|95.0|-2.0|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 35||0.3|-2.0|0.1538
91586507|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4047|TWO_SIDED|95.0|-1.7|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 35||0.7|-1.7|0.4047
91586508|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.026|TWO_SIDED|95.0|-2.5|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 36||-0.2|-2.5|0.0260
91586509|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1223|TWO_SIDED|95.0|-2.1|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 36||0.3|-2.1|0.1223
91586510|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3641|TWO_SIDED|95.0|-1.7|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 36||0.6|-1.7|0.3641
91586511|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0284|TWO_SIDED|95.0|-2.6|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 37||-0.1|-2.6|0.0284
91586512|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.61||0.1534|TWO_SIDED|95.0|-2.1|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 37||0.3|-2.1|0.1534
91586513|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3914|TWO_SIDED|95.0|-1.7|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 37||0.7|-1.7|0.3914
91647418|NCT01966107|183186580|SUPERIORITY||Rate ratio|0.65||||0.006|TWO_SIDED|95.0|0.48|0.89|||Negative Binomial Regression model||||A rate ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|0.89|0.48|0.006
91779616|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7||||0.0259|TWO_SIDED|95.0|14.5|223.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||223.0|14.5|0.0259
91779617|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|103.2||||0.0525|TWO_SIDED|95.0|-1.1|207.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.5|-1.1|0.0525
91779618|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|60.2||||0.2558|TWO_SIDED|95.0|-44.1|164.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.4|-44.1|0.2558
91779619|NCT01746901|183439341|SUPERIORITY_OR_OTHER||LS Mean Difference|88.6||||0.0952|TWO_SIDED|95.0|-15.7|192.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||192.9|-15.7|0.0952
91779620|NCT01746901|183439342|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0298|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.2|-3.3|0.0298
91779621|NCT01746901|183439342|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|1.1|0.0008
91779622|NCT01746901|183439342|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.645|TWO_SIDED|95.0|-2.0|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.0|0.6450
91779623|NCT01746901|183439342|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0962|TWO_SIDED|95.0|-0.2|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-0.2|0.0962
91779624|NCT01746901|183439342|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.193|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.5|-2.6|0.1930
91586514|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0265|TWO_SIDED|95.0|-2.6|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 38||-0.2|-2.6|0.0265
91708927|NCT02081001|183311170|SUPERIORITY_OR_OTHER||Point estimate ratio|1.36|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|90.0|1.11|1.67|||Mixed Models Analysis|||||1.67|1.11|0.02
91708928|NCT02081001|183311171|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.19||0.15|TWO_SIDED|90.0|0.97|1.64|||Mixed Models Analysis|||||1.64|0.97|0.15
91708929|NCT02081001|183311171|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.26||0.24|TWO_SIDED|90.0|0.9|1.84|||Mixed Models Analysis|||||1.84|0.90|0.24
91708930|NCT02081001|183311171|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.15||0.31|TWO_SIDED|90.0|0.6|1.14|||Mixed Models Analysis|||||1.14|0.60|0.31
91708931|NCT02081001|183311172|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.09|TWO_SIDED|90.0|1.01|1.39|||Mixed Models Analysis|||||1.39|1.01|0.09
91708932|NCT02081001|183311172|SUPERIORITY_OR_OTHER||Point estimate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.12||0.29|TWO_SIDED|90.0|0.93|1.35|||Mixed Models Analysis|||||1.35|0.93|0.29
91708933|NCT02081001|183311172|SUPERIORITY_OR_OTHER||Point estimate ratio|1.11|STANDARD_ERROR_OF_MEAN|0.09||0.24|TWO_SIDED|90.0|0.96|1.28|||Mixed Models Analysis|||||1.28|0.96|0.24
91708934|NCT02081001|183311173|SUPERIORITY_OR_OTHER||Point estimate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.22||0.7|TWO_SIDED|90.0|0.6|1.38|||Mixed Models Analysis|||||1.38|0.60|0.70
91708935|NCT02081001|183311173|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|90.0|0.94|1.68|||Mixed Models Analysis|||||1.68|0.94|0.19
91708936|NCT02081001|183311173|SUPERIORITY_OR_OTHER||Point estmate ratio|1.45|STANDARD_ERROR_OF_MEAN|0.26||0.052|TWO_SIDED|90.0|1.07|1.98|||Mixed Models Analysis|||||1.98|1.07|0.052
91708937|NCT02081001|183311174|SUPERIORITY_OR_OTHER||Point estimate ratio|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|90.0|0.87|4.66|||Mixed Models Analysis|||||4.66|0.87|0.16
91708938|NCT02081001|183311174|SUPERIORITY_OR_OTHER||Point estimate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.49||0.48|TWO_SIDED|90.0|0.68|2.54|||Mixed Models Analysis|||||2.54|0.68|0.48
91708939|NCT02081001|183311174|SUPERIORITY_OR_OTHER||Point estimate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.16||0.28|TWO_SIDED|90.0|0.57|1.13|||Mixed Models Analysis|||||1.13|0.57|0.28
91708940|NCT02081001|183311175|SUPERIORITY_OR_OTHER||Point estimate ratio|1.06|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|90.0|0.87|1.3|||Mixed Models Analysis|||||1.30|0.87|0.61
91708941|NCT02081001|183311175|SUPERIORITY_OR_OTHER||Point estimate ratio|1.19|STANDARD_ERROR_OF_MEAN|0.16||0.22|TWO_SIDED|90.0|0.94|1.5|||Mixed Models Analysis|||||1.5|0.94|0.22
91708942|NCT02081001|183311175|SUPERIORITY_OR_OTHER||Point estimate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.12||0.26|TWO_SIDED|90.0|0.66|1.09|||Mixed Models Analysis|||||1.09|0.66|0.26
91708943|NCT02081001|183311176|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.14||0.19|TWO_SIDED|90.0|0.96|1.46|||Mixed Models Analysis|||||1.46|0.96|0.19
91708944|NCT02081001|183311176|SUPERIORITY_OR_OTHER||Point estimate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|90.0|0.95|1.38|||Regression, Cox|||||1.38|0.95|0.21
91708945|NCT02081001|183311176|SUPERIORITY_OR_OTHER||Point estimate ratio|1.13|STANDARD_ERROR_OF_MEAN|0.1||0.19|TWO_SIDED|90.0|0.97|1.31|||Mixed Models Analysis|||||1.31|0.97|0.19
91708946|NCT02081001|183311177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.4||0.24|TWO_SIDED|95.0|-17.1|4.3|||Mixed Models Analysis|||||4.3|-17.1|0.24
91779625|NCT01746901|183439342|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.031|TWO_SIDED|95.0|0.2|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.2|0.0310
91779626|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|41.5|||<|0.0001|TWO_SIDED|95.0|33.9|49.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.0|33.9|<0.0001
91779627|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.3763|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-4.2|0.3763
91779628|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|10.7|25.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.8|10.7|<0.0001
91779629|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.1|19.1|<0.0001
91779630|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.1|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|13.1|<0.0001
91779631|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|11.8|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.8|<0.0001
91779632|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|284.3|||<|0.0001|TWO_SIDED|95.0|232.9|335.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||335.8|232.9|<0.0001
91586515|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1682|TWO_SIDED|95.0|-2.0|0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 38||0.4|-2.0|0.1682
91586516|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.59||0.4699|TWO_SIDED|95.0|-1.6|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 38||0.7|-1.6|0.4699
91586517|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0241|TWO_SIDED|95.0|-2.5|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 39||-0.2|-2.5|0.0241
91521216|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0274|TWO_SIDED|95.0|0.0|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.8|0.0|0.0274
91779633|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|31.2||||0.2336|TWO_SIDED|95.0|-20.4|82.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||82.8|-20.4|0.2336
91779634|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|167.3|||<|0.0001|TWO_SIDED|95.0|115.7|218.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||218.9|115.7|<0.0001
91708947|NCT02081001|183311177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|5.4||0.0005|TWO_SIDED|95.0|-30.1|-8.7|||Mixed Models Analysis|||||-8.7|-30.1|0.0005
91779635|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|148.3|||<|0.0001|TWO_SIDED|95.0|96.8|199.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.7|96.8|<0.0001
91779636|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|135.6|||<|0.0001|TWO_SIDED|95.0|84.0|187.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||187.2|84.0|<0.0001
91779637|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|113.6|||<|0.0001|TWO_SIDED|95.0|62.1|165.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||165.0|62.1|<0.0001
91779638|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|278.3|||<|0.0001|TWO_SIDED|95.0|213.2|343.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.3|213.2|<0.0001
91779639|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|71.3||||0.0322|TWO_SIDED|95.0|6.1|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|6.1|0.0322
91779640|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|195.4|||<|0.0001|TWO_SIDED|95.0|130.2|260.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||260.5|130.2|<0.0001
91779641|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3|||<|0.0001|TWO_SIDED|95.0|89.2|219.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||219.3|89.2|<0.0001
91779642|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|143.2|||<|0.0001|TWO_SIDED|95.0|78.0|208.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||208.4|78.0|<0.0001
91779643|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0002|TWO_SIDED|95.0|61.7|191.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||191.8|61.7|0.0002
91779644|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|202.4|||<|0.0001|TWO_SIDED|95.0|118.4|286.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||286.4|118.4|<0.0001
91779645|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|137.6||||0.0015|TWO_SIDED|95.0|53.3|221.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||221.8|53.3|0.0015
91779646|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|192.9|||<|0.0001|TWO_SIDED|95.0|108.7|277.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||277.2|108.7|<0.0001
91779647|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0||||0.0007|TWO_SIDED|95.0|63.0|231.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||231.1|63.0|0.0007
91779648|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|148.1||||0.0007|TWO_SIDED|95.0|63.9|232.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||232.4|63.9|0.0007
91779649|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|109.6||||0.011|TWO_SIDED|95.0|25.5|193.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.6|25.5|0.0110
91779650|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|107.4|284.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||284.6|107.4|<0.0001
91779651|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|133.9||||0.0034|TWO_SIDED|95.0|45.0|222.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||222.8|45.0|0.0034
91779652|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|190.9|||<|0.0001|TWO_SIDED|95.0|102.1|279.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||279.8|102.1|<0.0001
91521217|NCT02954354|182917040|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6001|TWO_SIDED|95.0|-0.3|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.3|0.6001
91779653|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|138.9||||0.0023|TWO_SIDED|95.0|50.3|227.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.6|50.3|0.0023
91779654|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|147.8||||0.0013|TWO_SIDED|95.0|59.0|236.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.7|59.0|0.0013
91779655|NCT01746901|183439343|SUPERIORITY_OR_OTHER||LS Mean Difference|100.0||||0.0273|TWO_SIDED|95.0|11.3|188.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||188.6|11.3|0.0273
91779656|NCT01746901|183439344|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-1.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.8|-5.0|<0.0001
91586518|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.1064||0.1064|TWO_SIDED|95.0|-2.1|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 39||0.2|-2.1|0.1064
91586519|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.2948|TWO_SIDED|95.0|-1.7|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 39||0.5|-1.7|0.2948
91586520|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0282|TWO_SIDED|95.0|-2.5|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 40||-0.1|-2.5|0.0282
91586521|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.59||0.1074|TWO_SIDED|95.0|-2.1|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 40||0.2|-2.1|0.1074
91586522|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3061|TWO_SIDED|95.0|-1.7|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 40||0.5|-1.7|0.3061
91586523|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.59||0.0705|TWO_SIDED|95.0|-2.2|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 41||0.1|-2.2|0.0705
91586524|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.59||0.2405|TWO_SIDED|95.0|-1.9|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 41||0.5|-1.9|0.2405
91586525|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.3726|TWO_SIDED|95.0|-1.7|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 41||0.6|-1.7|0.3726
91586526|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.0554|TWO_SIDED|95.0|-2.3|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 42||0.0|-2.3|0.0554
91586527|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.2386|TWO_SIDED|95.0|-1.8|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 42||0.5|-1.8|0.2386
91586528|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.5147|TWO_SIDED|95.0|-1.5|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 42||0.8|-1.5|0.5147
91586529|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.58||0.1116|TWO_SIDED|95.0|-2.1|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 43||0.2|-2.1|0.1116
91586530|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.58||0.1266|TWO_SIDED|95.0|-2.0|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 43||0.3|-2.0|0.1266
91586531|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.57||0.3822|TWO_SIDED|95.0|-1.6|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 43||0.6|-1.6|0.3822
91708948|NCT02081001|183311177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|-34.0|-12.6|||Mixed Models Analysis|||||-12.6|-34.0|<0.0001
91708949|NCT02081001|183311178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|1.6||0.22|TWO_SIDED|95.0|-5.1|1.2|||Mixed Models Analysis|||||1.2|-5.1|0.22
91708950|NCT02081001|183311178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.58|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Analysis|||||2.3|-4.0|0.58
91708951|NCT02081001|183311178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.6||0.03|TWO_SIDED|95.0|-6.7|-0.4|||Mixed Models Analysis|||||-0.4|-6.7|0.03
91708952|NCT02937636|183311179|OTHER||Least square (LS) mean difference|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.07|||ANCOVA|From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate.|Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.07|-0.12|<.0001
91708953|NCT04208412|183311185|SUPERIORITY|||||||0.001|||||||Wilcoxon Test (Gehan's Generalized)|||||||0.0010
91708954|NCT04208412|183311186|SUPERIORITY|||||||0.0045|||||||Prescott's Test|||||||0.0045
91708955|NCT04208412|183311187|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||"Gehan's Generalized Wilcoxon Test:~600 mg KVD900 vs Placebo"||||<0.0001
91708956|NCT04208412|183311188|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
91708957|NCT04208412|183311189|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
91708958|NCT00795769|183311209|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.||||0.03
91586532|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.59||0.072|TWO_SIDED|95.0|-2.2|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 44||0.1|-2.2|0.0720
91647419|NCT01966107|183186582|NON_INFERIORITY|Estimate of the hazard ratio and its 95% CI for comparing aclidinium bromide 400 μg versus placebo were derived using the Cox proportional hazard model. A hazard ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.64|1.23||||||Composite MACE||1.23|0.64|
91647420|NCT02200614|183186583|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|1e-06|TWO_SIDED|95.0|0.341|0.5|||Log Rank||Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.500|0.341|<0.000001
91647421|NCT02200614|183186584|SUPERIORITY||Hazard Ratio (HR)|0.706||||0.04521|TWO_SIDED|95.0|0.501|0.994|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.994|0.501|0.045210
91647422|NCT02200614|183186585|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
91647423|NCT02200614|183186586|SUPERIORITY||Hazard Ratio (HR)|0.433|||<|1e-06|TWO_SIDED|95.0|0.314|0.595|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.595|0.314|<0.000001
91647424|NCT02200614|183186587|SUPERIORITY||Hazard Ratio (HR)|0.428||||0.011262|TWO_SIDED|95.0|0.218|0.842|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.842|0.218|0.011262
91647425|NCT02200614|183186588|SUPERIORITY||Hazard Ratio (HR)|0.685||||0.003048|TWO_SIDED|95.0|0.533|0.881|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.881|0.533|0.003048
91647426|NCT02200614|183186589|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
91708959|NCT00795769|183311209|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC||||<0.0001
91586533|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3434|TWO_SIDED|95.0|-1.7|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 44||0.6|-1.7|0.3434
91586534|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.5061|TWO_SIDED|95.0|-1.5|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 44||0.8|-1.5|0.5061
91647427|NCT02200614|183186590|SUPERIORITY||Hazard Ratio (HR)|0.579||||4.4e-05|TWO_SIDED|95.0|0.444|0.755|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.755|0.444|0.000044
91779657|NCT01746901|183439344|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0004|TWO_SIDED|95.0|1.3|4.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|1.3|0.0004
91779658|NCT01746901|183439344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8478|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8478
91647428|NCT02200614|183186591|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.005294|TWO_SIDED|95.0|0.287|0.815|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.815|0.287|0.005294
91647429|NCT00759759|183186638|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|90.46||||||90.0|82.9|98.7|||ANOVA|||ANOVA of ln-transformed plasma morphine Cmax||98.7|82.9|
91708960|NCT00435188|183311211|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus p value for group difference between groups at the end of the study and group by time interaction|Mixed Models Analysis|||||||<0.001
91708961|NCT00435188|183311214|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedom||||0.47
91708962|NCT00435188|183311217|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedom||||0.04
91708963|NCT00435188|183311218|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall differences between groups at the end of the study||||<0.001
91779659|NCT01746901|183439344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.6192|TWO_SIDED|95.0|-1.9|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.9|0.6192
91779660|NCT01746901|183439344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8857|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8857
91779661|NCT01746901|183439344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5092|TWO_SIDED|95.0|-2.1|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-2.1|0.5092
91779662|NCT03594110|183439357|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0017 required at interim analysis."|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|99.83|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|<0.0001
91779663|NCT03594110|183439358|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0145 required at interim analysis."|Hazard Ratio (HR)|0.84||||0.1363|TWO_SIDED|98.55|0.63|1.12|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first hospitalization for heart failure or cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.12|0.63|0.1363
91779664|NCT03594110|183439359|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of \<0.0097 required at interim analysis.|Hazard Ratio (HR)|0.86||||0.0022|TWO_SIDED|99.03|0.76|0.98|||Joint frailty model||Comparison vs. Placebo|Hazard ratio (HR) of the time to occurrences of all-cause hospitalizations (first and recurrent combined). HR based on an analysis of recurrent events accounting for terminal events using a joint frailty model with terms for age, log(local screening UACR), local screening Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), treatment, sex, screening diabetes status, region.||0.98|0.76|0.0022
91779665|NCT03594110|183439360|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0290 required at interim analysis."|Hazard Ratio (HR)|0.87||||0.2122|TWO_SIDED|97.1|0.68|1.11|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to death from any cause. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.11|0.68|0.2122
91779666|NCT03594110|183439361|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.81|0.62|<0.0001
91779667|NCT03594110|183439362|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.83||||0.2932|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||1.17|0.59|0.2932
91779668|NCT03594110|183439363|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.72||||0.0017|TWO_SIDED|95.0|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence cardiovascular death or end stage kidney disease (ESKD). HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|0.0017
91779669|NCT03594110|183439364|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
91779670|NCT03594110|183439365|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
91779671|NCT03594110|183439366|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.72|0.9|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of death from any cause or ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.90|0.72|
91586535|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.0366|TWO_SIDED|95.0|-2.3|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 45||-0.1|-2.3|0.0366
91779672|NCT03594110|183439367|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.64|
91779673|NCT03594110|183439368|OTHER||Mean Difference (Net)|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||Mixed Models Analysis||\[Comparator\] - \[Placebo\]|A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction.||-0.11|-0.38|< 0.001
91779674|NCT03594110|183439369|OTHER||Mean Difference (Net)|-12.0||||0.41|TWO_SIDED|95.0|-42.0|17.0|||Regression, Linear||\[Comparator\]-\[Placebo\]|Differences in MRI measurements between treatment groups were assessed using a linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.||17|-42|0.41
91779675|NCT02177032|183439377|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-2.4|0.0|||Fisher Exact|||||0|-2.4|
91779676|NCT02177032|183439378|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667."|Vaccine Group Ratios|0.46|||||TWO_SIDED|95.0|0.37|0.58|||ANOVA|||||0.58|0.37|
91779677|NCT02177032|183439379|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)"|Vaccine Group Ratios|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANOVA|||||1.29|0.84|
91779678|NCT02177032|183439379|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)"|Vaccine Group Ratios|1.68|||||TWO_SIDED|95.0|1.35|2.1|||ANOVA|||||2.1|1.35|
91779679|NCT02177032|183439379|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91)."|Vaccine Group Ratios|0.68|||||TWO_SIDED|95.0|0.54|0.85|||ANOVA|||||0.85|0.54|
91779680|NCT02177032|183439379|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)"|Vaccine Group Ratios|1.22|||||TWO_SIDED|95.0|0.94|1.59|||ANOVA|||||1.59|0.94|
91779681|NCT02177032|183439379|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)"|Vaccine Group Ratios|1.67|||||TWO_SIDED|95.0|1.27|2.19|||ANOVA|||||2.19|1.27|
91779682|NCT02177032|183439380|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|9.0|||||TWO_SIDED|95.0|3.8|13.9|||Fisher Exact|||||13.9|3.8|
91779683|NCT02177032|183439380|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.6|||Fisher Exact|||||1.6|-1|
91779684|NCT02177032|183439380|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-3.0|||||TWO_SIDED|95.0|-6.0|-1.4|||Fisher Exact|||||-1.4|-6|
91779685|NCT02177032|183439380|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-4.5|3.2|||Fisher Exact|||||3.2|-4.5|
91521218|NCT02954354|182917041|SUPERIORITY||Difference|-17.5|||<|0.0001|TWO_SIDED|95.0|-21.1|-11.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-11.9|-21.1|<0.0001
91521219|NCT02954354|182917042|SUPERIORITY|||||||0.9225||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.9225
91779686|NCT02177032|183439380|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|6.0|||||TWO_SIDED|95.0|1.3|11.5|||Fisher Exact|||||11.5|1.3|
91779687|NCT02177032|183439381|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-11.0|||||TWO_SIDED|95.0|-19.6|-1.0|||Fisher Exact|||||-1|-19.6|
91586536|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.1181|TWO_SIDED|95.0|-2.0|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 45||0.2|-2.0|0.1181
91647430|NCT00759759|183186640|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA performed on the ratio of geometric means|mean ratio|101.1||||||90.0|96.9|105.4|||ANOVA|||Statistical analysis of ln-transformed plasma morphine AUClast||105.4|96.9|
91708964|NCT00435188|183311221|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall difference between groups at the end of the study||||0.29
91708965|NCT00435188|183311224|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|||P value provides overall differences between groups at the end of the study||||0.35
91708966|NCT00435188|183311227|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||P value provides the overall differences between groups at the end of the study||||0.08
91708967|NCT01420016|183311234|EQUIVALENCE|The analysis used a time-by-condition mixed model to estimate the annual rate of change in post-index CV risk values by treatment group. The models included fixed effects for study arm (CDS vs. UC), time (years since index), and study-arm-by-time comparing the rate of change in CDS versus UC and a random clinic intercept. The intervention effect was the difference in rate of change in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|Slope Difference (Net)|-2.25|||<|0.05|TWO_SIDED|95.0|-3.45|-1.04||A priori power analysis (power=.80, α2=.05) estimated detectable group difference in CVR at 1 year of \~2-3%, assuming 18 clinics, 1000 patients per clinic (actual 400), 3 CVR per patient (actual 2.3), and ICC=.01-03 (actual .019). p-value calculated.|Mixed Models Analysis||The intervention effect was the difference in annualized rates of change (slope) in CV risk in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|||-1.04|-3.45|<0.05
91708968|NCT01454414|183311235|SUPERIORITY_OR_OTHER_LEGACY||Protective effectiveness= 1 - rate ratio|0.646||||0.004|TWO_SIDED|95.0|0.288|0.824|||Poisson regression|||Protective effectiveness (1 - the incidence rate ratio) and 95% CIs for comparing reported tick bites between the treatment and control groups were calculated using a GEE model with a Poisson distribution and log link, and included terms for treatment, year of follow-up, and the interaction of treatment and year of follow-up, with an offset variable for log outdoor work hours.||0.824|0.288|0.004
91708969|NCT02774005|183311237|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0021|TWO_SIDED|95.0|1.352|3.884|||Wald Chi-square|||||3.884|1.352|0.0021
91708970|NCT02774005|183311238|SUPERIORITY||Odds Ratio (OR)|1.646||||0.0873|TWO_SIDED|95.0|0.929|2.918|||Waldi-Chi-Square|||||2.918|0.929|0.0873
91708971|NCT02774005|183311239|SUPERIORITY||Odds Ratio (OR)|7.323||||0.0005|TWO_SIDED|95.0|2.339|25.912|||Waldi-Chi-Square|||||25.912|2.339|0.0005
91708972|NCT03275389|183311282|EQUIVALENCE|The use of the adjuvant (AS03) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|2.47|||||TWO_SIDED|94.46|2.06|2.95|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS03 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 1, at Day 29 of D-SUIV Adjuvant Group 2 and Day 85 of D-SUIV Adjuvant Group 3) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.95|2.06|
91708973|NCT03275389|183311282|EQUIVALENCE|The use of the adjuvant (AS01) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|1.75|||||TWO_SIDED|94.46|1.46|2.1|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS01 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 4, at Day 29 of D-SUIV Adjuvant Group 5 and Day 85 of D-SUIV Adjuvant Group 6) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.1|1.46|
91708974|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.462||0.6797||95.0|-0.83|1.22|||ANOVA|||Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose.||1.22|-0.83|0.6797
91708975|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.528||0.4811||95.0|-1.54|0.77|||ANOVA|||Difference from placebo (including Baseline), Day 1: 1 hour post-dose.||0.77|-1.54|0.4811
91708976|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.454||0.1693||95.0|-1.67|0.33|||ANOVA|||Difference from placebo (including Baseline), Day 1: 2 hours post-dose.||0.33|-1.67|0.1693
91708977|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.487||0.4034||95.0|-1.78|0.87|||ANOVA|||Difference from placebo (including Baseline) , Day 1: 3 hours post-dose.||0.87|-1.78|0.4034
91708978|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.694||0.1935||95.0|-2.36|0.5|||ANOVA|||Difference from placebo (including Baseline), Day 1: 4 hours post-dose.||0.50|-2.36|0.1935
91779688|NCT02177032|183439381|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-5.6|2.6|||Fisher Exact|||||2.6|-5.6|
91779689|NCT02177032|183439381|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-15.0|||||TWO_SIDED|95.0|-26.0|-7.1|||Fisher Exact|||||-7.1|-26|
91586537|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.7078|TWO_SIDED|95.0|-1.3|0.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 45||0.9|-1.3|0.7078
91586538|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.58||0.0868|TWO_SIDED|95.0|-2.1|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 46||0.1|-2.1|0.0868
91586539|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.57||0.1683|TWO_SIDED|95.0|-1.9|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 46||0.3|-1.9|0.1683
91586540|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.57||0.8909|TWO_SIDED|95.0|-1.2|1.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 46||1.1|-1.2|0.8909
91586541|NCT03816891|183063657|OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.59||0.0671|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 47||0.1|-2.3|0.0671
91779690|NCT02177032|183439381|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-17.0|||||TWO_SIDED|95.0|-29.0|-7.1|||Fisher Exact|||||-7.1|-29|
91521220|NCT02954354|182917043|SUPERIORITY|||||||0.7866||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.7866
91586542|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.59||0.3325|TWO_SIDED|95.0|-1.7|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 47||0.6|-1.7|0.3325
91586543|NCT03816891|183063657|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8912|TWO_SIDED|95.0|-1.2|1.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 47||1.1|-1.2|0.8912
91586544|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.0612|TWO_SIDED|95.0|-2.2|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||0.1|-2.2|0.0612
91586545|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.58||0.1879|TWO_SIDED|95.0|-1.9|0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||0.4|-1.9|0.1879
91586546|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7696|TWO_SIDED|95.0|-1.3|1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||1.0|-1.3|0.7696
91586547|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1211|TWO_SIDED|95.0|-2.1|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 49||0.2|-2.1|0.1211
91586548|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.3908|TWO_SIDED|95.0|-1.7|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 49||0.7|-1.7|0.3908
91586549|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.61||0.8036|TWO_SIDED|95.0|-1.1|1.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 49||1.4|-1.1|0.8036
91779691|NCT02177032|183439381|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-25.0|||||TWO_SIDED|95.0|-37.8|-13.2|||Fisher Exact|||||-13.2|-37.8|
91586550|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.63||0.0928|TWO_SIDED|95.0|-2.3|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 50||0.2|-2.3|0.0928
91586551|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.63||0.4439|TWO_SIDED|95.0|-1.7|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 50||0.8|-1.7|0.4439
91586552|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.63||0.7769|TWO_SIDED|95.0|-1.4|1.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 50||1.1|-1.4|0.7769
91586553|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.61||0.0742|TWO_SIDED|95.0|-2.3|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 51||0.1|-2.3|0.0742
91647431|NCT00759759|183186641|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.3||||||90.0|96.2|106.7|||ANOVA|||||106.7|96.2|
91779692|NCT01598532|183439391|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.004
91779693|NCT01598532|183439392|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.003
91779694|NCT01598532|183439393|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for effect of LED treatments||||<0.003
91779695|NCT01598532|183439394|SUPERIORITY_OR_OTHER||||||<|0.006|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effects of LED treatments||||<0.006
91779696|NCT00912808|183439397|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.049
91779697|NCT00912808|183439398|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.27
91586554|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.63||0.1496|TWO_SIDED|95.0|-2.2|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 51||0.3|-2.2|0.1496
91586555|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4901|TWO_SIDED|95.0|-1.6|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 51||0.8|-1.6|0.4901
91586556|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0895|TWO_SIDED|95.0|-2.3|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||0.2|-2.3|0.0895
91647432|NCT01556165|183186654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.32||0.0254|TWO_SIDED|75.0|-4.53|-1.47||No adjustments for multiple comparisons were made.|ANCOVA|||This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.||-1.47|-4.53|0.0254
91779698|NCT01967940|183439449|SUPERIORITY|Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.|Difference in proportions|60.7|||<|0.001|TWO_SIDED|95.0|42.6|78.8|||Fisher Exact||The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.||78.8|42.6|<0.001
91779699|NCT05567783|183439475|SUPERIORITY||Relative risk reduction (RRR, %)|15.85||||0.5552|TWO_SIDED|95.0|-49.27|52.56||two-sided, alpha=0.05|Poisson regression|Estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model|RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group was the only factor in the model|||52.56|-49.27|0.5552
91779700|NCT05567783|183439475|SUPERIORITY||Relative risk reduction (RRR, %)|3.78|||||TWO_SIDED|95.0|-67.23|44.63|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||44.63|-67.23|
91779701|NCT05567783|183439483|SUPERIORITY||Relative risk reduction (RRR, %)|57.23|||||TWO_SIDED|95.0|-2.51|82.15|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||82.15|-2.51|
91779702|NCT05567783|183439483|SUPERIORITY||Relative risk reduction (RRR, %)|11.45|||||TWO_SIDED|95.0|-76.25|55.51|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||55.51|-76.25|
91779703|NCT05567783|183439484|SUPERIORITY||Relative risk reduction (RRR, %)|44.13|||||TWO_SIDED|95.0|-50.49|79.26|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||79.26|-50.49|
91779704|NCT05567783|183439484|SUPERIORITY||Relative risk reduction (RRR, %)|-9.8|||||TWO_SIDED|95.0|-147.41|51.27|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||51.27|-147.41|
91779705|NCT00940771|183439493|OTHER|Friedman's Test|Chi Square|12.3||||0.006|TWO_SIDED||||||Friedman's Test|3 degrees of freedom.||||||.006
91779706|NCT00940771|183439493|OTHER|Post Hoc testing Post hoc Wilcoxon Signed Rank tests||||||0.007|||||||Wilcoxon Signed Rank|Z=-2.701||Nul lHypothesis that there is no difference between specific time points.||||.007
91779707|NCT00940771|183439494|OTHER|Friedman's test with 3 df||||||0.356|||||||Friedman's Test|3 degrees of freedom||||||.356
91779708|NCT00940771|183439495|OTHER||Chi-square|1.0||||0.801|TWO_SIDED||||||Friedman's test|3 degrees of freedom|1.0 is the actual calculated Chi-X value, not the p value.|The null hypothesis was that there was a difference. We were looking for no difference between before and after switch.||||.801
91521221|NCT02954354|182917043|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||<0.0001
91779709|NCT00940771|183439496|OTHER|Friedman's test||||||0.075||||||a priori threshold for statistical significance 0.05|Friedman's test|3 degrees of freedom||||||.075
91779710|NCT02593006|183439498|SUPERIORITY||Risk Difference (RD)|10.3|||>|0.05|TWO_SIDED|95.0|-3.2|23.8|||Propensity weighted regression model|||||23.8|-3.2|>0.05
91779711|NCT02593006|183439499|SUPERIORITY|||||||0.04||||||Global test of interaction between time and treatment group.|Mixed Models Analysis|||||||0.04
91779712|NCT02072668|183439521|SUPERIORITY|||||||0.6281|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.6281
91779713|NCT02072668|183439522|SUPERIORITY|||||||0.7973|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7973
91779714|NCT02072668|183439523|SUPERIORITY|||||||0.4442|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4442
91779715|NCT02072668|183439524|SUPERIORITY|||||||0.2545|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.2545
91779716|NCT02072668|183439530|SUPERIORITY|||||||0.4374|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4374
91779717|NCT02072668|183439531|SUPERIORITY|||||||0.347|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.3470
91779718|NCT02072668|183439532|SUPERIORITY|||||||0.0755|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0755
91779719|NCT02072668|183439534|SUPERIORITY|||||||0.0708|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0708
91779720|NCT02072668|183439535|SUPERIORITY|||||||0.4501|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4501
91779721|NCT02072668|183439536|SUPERIORITY|||||||0.0767|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0767
91779722|NCT02072668|183439537|SUPERIORITY|||||||0.725|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7250
91779723|NCT01353898|183439539|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.62|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 200 mg MK-1972 once daily||||
91779724|NCT01353898|183439539|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 800 mg MK-1972 once daily||||
91779725|NCT01353898|183439540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||||||||||||||||
91779726|NCT01353898|183439540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||||||||||||||||
91779727|NCT01353898|183439540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||||||||||||||||
91779728|NCT01353898|183439540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||||||||||||||||
91779729|NCT01353898|183439540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||||||||||||||||
91779730|NCT04322526|183439555|OTHER|||||||0.01|||||||t-test, 2 sided|||Changes in BOLD signal in the rACC during the processing of contextual cues (pleasant \> unpleasant).||||0.01
91779731|NCT04322526|183439556|OTHER|Mechanistic hypothesis: naltrexone will block contextual processing.||||||0.0002|||||||t-test, 2 sided|||Changes in BOLD fMRI signal from the Placebo vs. the Naltrexone session.||||0.0002
91779732|NCT02453321|183439616|SUPERIORITY|||||||0.355|||||||Kruskal-Wallis|||||||0.355
91779733|NCT02453321|183439617|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
91779734|NCT02230670|183439622|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.0817||0.091|TWO_SIDED|95.0|-0.302|0.023|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.023|-0.302|0.091
91779735|NCT02230670|183439622|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.041|TWO_SIDED|95.0|-0.41|0.01|||ANCOVA|||The analysis was conducted using an ANCOVA model adjusting for baseline value, baseline MELD score, and etiology. The significance was assessed using Type II Sums of Squares from this ANCOVA model.||0.01|-0.41|0.041
91779736|NCT02230670|183439623|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.333||0.466|TWO_SIDED|95.0|-0.91|0.42|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.42|-0.91|0.466
91586557|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65||0.4572|TWO_SIDED|95.0|-1.8|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||0.8|-1.8|0.4572
91586558|NCT03816891|183063657|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8157|TWO_SIDED|95.0|-1.1|1.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||1.4|-1.1|0.8157
91647433|NCT01556165|183186655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.21||0.0032|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||-0.21|-1.03|0.0032
91647434|NCT01556165|183186656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.52||0.1963|TWO_SIDED|95.0|-1.7|0.35|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.35|-1.70|0.1963
91647435|NCT01556165|183186657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.91||0.0641|TWO_SIDED|95.0|-3.52|0.1|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.10|-3.52|0.0641
91779737|NCT02230670|183439623|SUPERIORITY||Median Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|1.42||0.003|TWO_SIDED|95.0|-3.61|-0.77|||ANCOVA|calculated from the estimated least square means for the treatment by BL MELD category interaction term.||BL MELD \>= 15 subgroup results (N=19), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.77|-3.61|0.003
91779738|NCT02230670|183439623|SUPERIORITY||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|95.0|-3.09|-0.17|||ANCOVA|calculated from the estimated least square means for the treatment by etiology interaction term.||NASH Etiology subgroup results (N=20), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.17|-3.09|0.029
91779739|NCT01907854|183439629|SUPERIORITY_OR_OTHER||Treatment difference|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.4|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.||-0.40|-0.82|<0.0001
91779740|NCT01907854|183439630|SUPERIORITY_OR_OTHER||Treatment difference|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.34|-0.99|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.||-0.99|-2.34|<0.0001
91779741|NCT02106390|183439636|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.71|1.1|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||"H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination."||1.10|0.71|
91779742|NCT02106390|183439636|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.74|1.45|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.||1.45|0.74|
91779743|NCT02106390|183439636|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.82|1.25|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.||1.25|0.82|
91779744|NCT02106390|183439636|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.77|1.4|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.||1.40|0.77|
91779745|NCT02106390|183439637|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|2.48|||||TWO_SIDED|95.0|1.97|3.11|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.||3.11|1.97|
91779746|NCT02106390|183439637|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.||1.38|0.83|
91779747|NCT02106390|183439637|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.04|1.74|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.||1.74|1.04|
91779748|NCT02106390|183439637|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.||1.35|0.82|
91779749|NCT02504151|183439687|SUPERIORITY||Mean Difference (Net)|-0.284|STANDARD_ERROR_OF_MEAN|1.01||0.08|TWO_SIDED|95.0|-2.28|1.71|||Mixed Models Analysis|Linear mixed models was used with treatment, time and time\*treatment interaction in the model.|This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||1.71|-2.28|0.08
91779750|NCT02504151|183439688|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.48|TWO_SIDED|95.0|-0.12|0.07|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||0.07|-0.12|0.48
91779751|NCT02504151|183439689|SUPERIORITY||Mean Difference (Net)|-4.97|STANDARD_ERROR_OF_MEAN|2.47||0.485|TWO_SIDED|95.0|-9.87|-0.06|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||-0.06|-9.87|0.485
91586559|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-21.6|-7.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 1||-7.5|-21.6|<0.0001
91586560|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|3.56||0.0368|TWO_SIDED|95.0|-14.5|-0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 1||-0.5|-14.5|0.0368
91708979|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.715||0.0694||95.0|-2.83|0.12|||ANOVA|||Difference from placebo (including Baseline), Day 1: 5 hours post-dose.||0.12|-2.83|0.0694
91708980|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.713||0.0396||95.0|-3.02|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 1: 6 hours post-dose.||-0.08|-3.02|0.0396
91779752|NCT02504151|183439690|SUPERIORITY||Mean Difference (Net)|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.994|TWO_SIDED|95.0|0.07|8.19|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||8.19|0.07|0.994
91708981|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.319||0.1531||95.0|-1.25|0.24|||ANOVA|||Difference from placebo (including Baseline), Day 1: 8 hours post-dose.||0.24|-1.25|0.1531
91779753|NCT00538902|183439691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.026||95.0|1.09|4.39||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||4.39|1.09|0.026
91586561|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.58||0.17|TWO_SIDED|95.0|-12.0|2.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 1||2.1|-12.0|0.1700
91586562|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001|TWO_SIDED|95.0|-35.1|-15.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-15.3|-35.1|<0.0001
91586563|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|4.96||0.0056|TWO_SIDED|95.0|-23.7|-4.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-4.1|-23.7|0.0056
91586564|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|4.99||0.0076|TWO_SIDED|95.0|-23.3|-3.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-3.6|-23.3|0.0076
91586565|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-32.0|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|95.0|-42.5|-21.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 3||-21.5|-42.5|<0.0001
91586566|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.2|STANDARD_ERROR_OF_MEAN|5.32||0.0014|TWO_SIDED|95.0|-27.7|-6.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 3||-6.7|-27.7|0.0014
91586567|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|5.35||0.0296|TWO_SIDED|95.0|-22.3|-1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 3||-1.2|-22.3|0.0296
91586568|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-35.9|STANDARD_ERROR_OF_MEAN|5.54|<|0.0001|TWO_SIDED|95.0|-46.9|-25.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-25.0|-46.9|<0.0001
91586569|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-20.6|STANDARD_ERROR_OF_MEAN|5.5||0.0002|TWO_SIDED|95.0|-31.4|-9.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-9.7|-31.4|0.0002
91586570|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|5.53||0.1652|TWO_SIDED|95.0|-18.6|3.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||3.2|-18.6|0.1652
91586571|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-38.2|STANDARD_ERROR_OF_MEAN|5.52|<|0.0001|TWO_SIDED|95.0|-49.1|-27.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 5||-27.3|-49.1|<0.0001
91586572|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-24.5|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|-35.3|-13.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 5||-13.7|-35.3|<0.0001
91779754|NCT00538902|183439691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.004||95.0|1.35|5.3||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||5.30|1.35|0.004
91779755|NCT00538902|183439692|SUPERIORITY_OR_OTHER|||||||0.009||||||The between-treatment comparison between each adalimumab group vs. placebo was performed at the 2-sided alpha = 0.05 significance level, without using a stepwise testing procedure or alpha adjustment.|Cochran-Mantel-Haenszel|Percentage ACR responders at Week 12 were compared between adalimumab and placebo groups, where missing ACR responses were imputed as non-responder.||||||0.009
91586573|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.6|STANDARD_ERROR_OF_MEAN|5.51||0.0146|TWO_SIDED|95.0|-24.5|-2.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 5||-2.7|-24.5|0.0146
91586574|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-39.0|STANDARD_ERROR_OF_MEAN|5.66|<|0.0001|TWO_SIDED|95.0|-50.2|-27.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 6||-27.8|-50.2|<0.0001
91586575|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-27.7|STANDARD_ERROR_OF_MEAN|5.59|<|0.0001|TWO_SIDED|95.0|-38.8|-16.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 6||-16.7|-38.8|<0.0001
91708982|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.637||0.0951||95.0|-2.79|0.29|||ANOVA|||Difference from placebo (including Baseline), Day 1: 10 hours post-dose.||0.29|-2.79|0.0951
91708983|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.615||0.0614||95.0|-2.84|0.09|||ANOVA|||Difference from placebo (including Baseline), Day 1: 12 hours post-dose.||0.09|-2.84|0.0614
91779756|NCT00538902|183439692|SUPERIORITY_OR_OTHER|||||||0.121|||||||Cochran-Mantel-Haenszel|||||||0.121
91779757|NCT02148874|183439714|SUPERIORITY||Odds Ratio (OR)|1.05||||0.84|TWO_SIDED|95.0|0.64|1.73|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1.||1.73|0.64|0.84
91521222|NCT02954354|182917043|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
91647436|NCT02395536|183186719|NON_INFERIORITY|A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting.|Risk Difference (RD)|-0.001|||<|0.001|TWO_SIDED|95.0|-0.03|0.029||P-value for non-inferiority versus a 5% non-inferiority margin.|Farrington-Manning test||The estimated value and its associated confidence interval are for the in-office minus traditional hospital setting difference in the untoward event rates. The point estimate is negative since the in-office rate was lower than the hospital rate.|The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.||0.029|-0.030|<0.001
91708984|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.619||0.1946||95.0|-2.29|0.54|||ANOVA|||Difference from placebo (including Baseline), Day 8: pre-dose.||0.54|-2.29|0.1946
91779758|NCT02148874|183439714|SUPERIORITY||Odds Ratio (OR)|1.07||||0.79|TWO_SIDED|95.0|0.65|1.75|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.75|0.65|0.79
91779759|NCT02148874|183439714|SUPERIORITY||Odds Ratio (OR)|1.26||||0.43|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Massachusetts||2.24|0.71|0.43
91779760|NCT02148874|183439714|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.63|1.87|||Regression, Logistic||Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Brisbane||1.87|0.63|0.77
91779761|NCT02148874|183439715|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2|TWO_SIDED|95.0|0.84|2.32|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||2.32|0.84|0.20
91779762|NCT02148874|183439715|SUPERIORITY||Odds Ratio (OR)|1.09||||0.74|TWO_SIDED|95.0|0.66|1.8|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.80|0.66|0.74
91779763|NCT02148874|183439715|SUPERIORITY||Odds Ratio (OR)|1.89||||0.04|TWO_SIDED|95.0|1.04|3.44|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||3.44|1.04|0.04
91779764|NCT02148874|183439715|SUPERIORITY||Odds Ratio (OR)|1.63||||0.13|TWO_SIDED|95.0|0.87|3.04|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||3.04|0.87|0.13
91779765|NCT02148874|183439716|SUPERIORITY||Odds Ratio (OR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||1.48|0.53|0.64
91779766|NCT02148874|183439716|SUPERIORITY||Odds Ratio (OR)|0.89||||0.67|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.50|0.53|0.67
91779767|NCT02148874|183439716|SUPERIORITY||Odds Ratio (OR)|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||2.46|0.88|0.14
91779768|NCT02148874|183439716|SUPERIORITY||Odds Ratio (OR)|0.74||||0.25|TWO_SIDED|95.0|0.44|1.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||1.24|0.44|0.25
91779769|NCT01782378|183439717|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.33|<|0.01|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.01
91779770|NCT01782378|183439718|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.88||0.88|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.88
91779771|NCT01782378|183439719|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.59||0.81|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.81
91647437|NCT04876482|183186745|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-10.76|||<|0.05|TWO_SIDED||||||Regression, Linear|||"We hypothesized that the improvements in the AHI would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).~."||||<0.05
91647438|NCT04876482|183186746|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.05|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the upper airway volume would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647439|NCT04876482|183186747|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.275|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the minimal area on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls)||||<0.05
91647440|NCT04876482|183186748|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the anteror to posterior distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647441|NCT04876482|183186749|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the lateral distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647442|NCT04876482|183186750|OTHER|Baseline characteristics among the study groups were compared using Fisher exact test for categorical variables. McNemar chi-square test used for within-group analysis.|Number and percentage|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||We hypothesized that TORS followed by OPR would improve upper airway obstruction more compared with TORS alone and conservative treatment (control).||||<0.05
91708985|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.553||0.2843||95.0|-2.2|0.84|||ANOVA|||Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose.||0.84|-2.20|0.2843
91708986|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.82||0.215||95.0|-2.75|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 1 hour post-dose.||0.65|-2.75|0.2150
91779772|NCT01782378|183439720|SUPERIORITY||Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|2.88||0.23|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||0.23
91779773|NCT01782378|183439721|SUPERIORITY||Mean Difference (Final Values)|11.39|STANDARD_ERROR_OF_MEAN|7.08|<|0.12|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.12
91779774|NCT01782378|183439722|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.93|<|0.52|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.52
91779775|NCT01782378|183439723|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|3.51|<|0.27|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.27
91779776|NCT01782378|183439724|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.26|<|0.37|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.37
91779777|NCT01782378|183439725|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.78|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
91779778|NCT01782378|183439726|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.46
91521223|NCT02954354|182917043|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
91779779|NCT01782378|183439727|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.83|<|0.84|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.84
91779780|NCT01782378|183439728|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.75|<|0.93|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.93
91779781|NCT01782378|183439729|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|3.02|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
91779782|NCT01782378|183439730|SUPERIORITY|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|Mean Difference (Final Values)|-14.43|STANDARD_ERROR_OF_MEAN|12.54|<|0.26|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results that were considered credible.||||||<0.26
91779783|NCT01782378|183439731|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.7|<|0.45|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.45
91779784|NCT01782378|183439732|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|1.18|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.46
91779785|NCT01782378|183439733|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.44|<|0.64|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.64
91779786|NCT01782378|183439734|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.63|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.82
91779787|NCT01782378|183439735|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.53|<|0.43|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.43
91779788|NCT01782378|183439736|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.15|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.15
91779789|NCT01782378|183439737|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|1.86||0.08|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||.08
91779790|NCT01782378|183439738|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.83|<|0.7|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.7
91779791|NCT01782378|183439739|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5|<|0.48|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.48
91779792|NCT01782378|183439740|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.16|<|0.02|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.02
91779793|NCT01782378|183439741|SUPERIORITY||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.19|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
91779794|NCT01782378|183439742|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.88|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.82
91779795|NCT01782378|183439743|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.84|<|0.2|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.2
91779796|NCT01782378|183439744|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.86|<|0.71|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.71
91779797|NCT01782378|183439745|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.73|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
91779798|NCT01782378|183439746|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.94|<|0.44|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.44
91779799|NCT00705016|183439747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.885|TWO_SIDED|95.0|0.67|1.59||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log Hazard ratio (HR), if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||1.59|0.67|0.885
91779800|NCT00705016|183439747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.55||||0.054|TWO_SIDED|95.0|0.99|2.43||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||2.43|0.99|0.054
91779801|NCT00705016|183439748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.61|1.47||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.47|0.61|0.800
91779802|NCT00705016|183439748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.878|TWO_SIDED|95.0|0.66|1.63|||Cox proportional hazards model|||||1.63|0.66|0.878
91779803|NCT00705016|183439749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.595||||0.205|TWO_SIDED|95.0|0.776|3.276||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.276|0.776|0.205
91779804|NCT00705016|183439749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.671||||0.317|TWO_SIDED|95.0|0.307|1.465||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.465|0.307|0.317
91779805|NCT00705016|183439750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.396||||0.476|TWO_SIDED|95.0|0.551|3.539||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.539|0.551|0.476
91779806|NCT00705016|183439750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.668||||0.347|TWO_SIDED|95.0|0.287|1.555||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.555|0.287|0.347
91779807|NCT00705016|183439751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.81||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.81|0.84|0.294
91779808|NCT00705016|183439751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.007|TWO_SIDED|95.0|1.16|2.57||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.57|1.16|0.007
91779809|NCT00705016|183439752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.391|TWO_SIDED|95.0|0.71|2.39||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.39|0.71|0.391
91779810|NCT00705016|183439752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.007|TWO_SIDED|95.0|1.3|5.21||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||5.21|1.30|0.007
91779811|NCT02233517|183439754|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.84|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.84
91779812|NCT02233517|183439754|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.52|<|0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||<0.44
91779813|NCT02233517|183439754|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.33|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.33
91779814|NCT02233517|183439755|SUPERIORITY|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.1||0.26|TWO_SIDED||||||Mixed Models Analysis|||Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.26
91779815|NCT02233517|183439756|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|1.16||0.9|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.90
91779816|NCT02233517|183439756|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|1.16||0.85|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.85
91779817|NCT02233517|183439756|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|1.16||0.79|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.79
91779818|NCT02233517|183439757|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_DEVIATION|3.2||0.05|TWO_SIDED|95.0|-4.5|-0.002|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.||-.002|-4.5|0.05
91779819|NCT02233517|183439757|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|2.09||0.53|TWO_SIDED|95.0|-2.03|1.08|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.||1.08|-2.03|0.53
91647443|NCT04876482|183186751|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.23|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the jaw opening muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647444|NCT04876482|183186752|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.45|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue protrusion muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647445|NCT04876482|183186753|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|4.81|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue elevation muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647446|NCT04876482|183186754|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|7.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue depression muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91647447|NCT04876482|183186755|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|3.67|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue lateralization muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
91779820|NCT02233517|183439757|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_DEVIATION|2.42||0.5|TWO_SIDED|95.0|-2.3|1.14|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.||1.14|-2.30|0.50
91779821|NCT02233517|183439758|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED||||||Mixed Models Analysis||The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).||||<0.0001
91779822|NCT02233517|183439759|SUPERIORITY||Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.71||0.59|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.59
91647448|NCT02464059|183186764|SUPERIORITY||Mean Difference (Final Values)|-65.5|STANDARD_DEVIATION|207.8||0.21|TWO_SIDED|95.0|-172.4|41.3||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||41.3|-172.4|0.21
91647449|NCT02464059|183186765|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|12.6||0.86|TWO_SIDED|95.0|-7.02|5.91||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||5.91|-7.02|0.86
91779823|NCT02233517|183439759|SUPERIORITY||Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|2.71||0.61|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.61
91779824|NCT02233517|183439759|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|2.71||0.74|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.74
91779825|NCT02233517|183439760|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.25|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.25
91779826|NCT02233517|183439760|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.16||0.97|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.97
91779827|NCT02233517|183439760|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.69|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.69
91779828|NCT02233517|183439761|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.66||0.29|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.29
91779829|NCT02233517|183439761|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.66||0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.44
91779830|NCT02233517|183439761|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.66||0.11|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.11
91779831|NCT02233517|183439762|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.16|TWO_SIDED||||||Mixed Models Analysis||Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in PTSD in PCT).|Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.16
91779832|NCT02233517|183439763|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.37||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.45
91779833|NCT02233517|183439763|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.37||0.55|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.55
91779834|NCT02233517|183439763|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.37||0.87|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.87
91586576|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.5|STANDARD_ERROR_OF_MEAN|5.62||0.0022|TWO_SIDED|95.0|-28.5|-6.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 6||-6.4|-28.5|0.0022
91779835|NCT02233517|183439764|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.04||0.49|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment.|||||0.49
91779836|NCT02233517|183439764|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.04||0.7|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.70
91779837|NCT02233517|183439764|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.04||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.45
91779838|NCT00942604|183439765|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91779839|NCT00942604|183439766|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91779840|NCT04109547|183439774|SUPERIORITY||Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.3|-1.8|<0.0001
91779841|NCT04109547|183439774|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.2|-1.6|<0.0001
91779842|NCT04109547|183439774|SUPERIORITY||Treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-0.8|-1.2|<0.0001
91586577|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-39.1|STANDARD_ERROR_OF_MEAN|5.92|<|0.0001|TWO_SIDED|95.0|-50.8|-27.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 7||-27.4|-50.8|<0.0001
91779843|NCT00817843|183439856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.295||0.766||95.0|||||ANOVA|||"Between treatment difference in the change in FMD from the fasting to the post-fat load state.~Null hypothesis was that combination therapy (simvastatin/ezetimibe) would protect the FMD in the post-fat load phase and would therefore be associated with a smaller drop in FMD~Power calculation was based on the results from a pilot study. To detect a 1.0% difference between treatments with a SD of 2.7% and a power of 90% (alfa 0.05, two tailed) 80 evaluable patients were needed."||||0.766
91779844|NCT01499355|183439860|SUPERIORITY_OR_OTHER|||||||0.367||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world \[ROW\]) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.367
91779845|NCT01499355|183439860|SUPERIORITY_OR_OTHER|||||||0.283||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.283
91779846|NCT01499355|183439861|SUPERIORITY_OR_OTHER|||||||0.0486||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0486
91779847|NCT01499355|183439861|SUPERIORITY_OR_OTHER|||||||0.0668||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0668
91779848|NCT01499355|183439862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0628||||0.0456|TWO_SIDED|90.0|0.0081|0.4843||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||0.4843|0.0081|0.0456
91779849|NCT01499355|183439862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4344||||0.5455|TWO_SIDED|90.0|0.0996|1.8941||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||1.8941|0.0996|0.5455
91779850|NCT01499355|183439862|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Cochran-Mantel-Haenszel|||||||0.0252
91779851|NCT01499355|183439862|SUPERIORITY_OR_OTHER|||||||0.2876|||||||Cochran-Mantel-Haenszel|||||||0.2876
91779852|NCT01499355|183439865|SUPERIORITY_OR_OTHER|||||||0.863|||||||Regression, Cox|||||||0.863
91779853|NCT01499355|183439865|SUPERIORITY_OR_OTHER|||||||0.769|||||||Regression, Cox|||||||0.769
91779854|NCT01499355|183439865|SUPERIORITY_OR_OTHER|||||||0.907|||||||ANCOVA|||||||0.907
91779855|NCT01499355|183439865|SUPERIORITY_OR_OTHER|||||||0.996|||||||ANCOVA|||||||0.996
91779856|NCT02668653|183439866|OTHER||Hazard Ratio (HR)|0.776||||0.0324|TWO_SIDED|95.0|0.615|0.979|||Log Rank|Stratification factors include region, age, and WBC count at the time of diagnosis of AML.||||0.979|0.615|0.0324
91779857|NCT00999102|183439893|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.67|TWO_SIDED|95.0|-1.86|2.86|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 5 mg minus Mean Global Fatigue Score for Metoprolol 50 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||2.86|-1.86|0.67
91779858|NCT00999102|183439893|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.72|TWO_SIDED|95.0|-3.17|4.55|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 10 mg minus Mean Global Fatigue Score for Metoprolol 100 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||4.55|-3.17|0.72
91779859|NCT00999102|183439894|SUPERIORITY||Mean Difference (Final Values)|-7.03||||0.89|TWO_SIDED|95.0|-108.99|94.92|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 5 mg minus Mean Treadmill Exercise Time for Metoprolol 50 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||94.92|-108.99|0.89
91779860|NCT00999102|183439894|SUPERIORITY||Mean Difference (Final Values)|-25.9||||0.43|TWO_SIDED|95.0|-91.55|39.75|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 10 mg minus Mean Treadmill Exercise Time for Metoprolol 100 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||39.75|-91.55|0.43
91779861|NCT01929317|183439907|SUPERIORITY_OR_OTHER||Mean change from Baseline|-4.8|||<|0.001|TWO_SIDED|95.0|-6.3|-3.2|||t-test, 1 sided|||||-3.2|-6.3|<0.001
91779862|NCT01929317|183439908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 2.|||2.0|-2.4|
91779863|NCT01929317|183439908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 4.|||3.1|-1.9|
91779864|NCT01929317|183439908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.3|3.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 6.|||3.0|-2.3|
91779865|NCT01929317|183439908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 8.|||2.0|-3.4|
91779866|NCT01929317|183439908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-2.0|3.9|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 12.|||3.9|-2.0|
91647450|NCT02499406|183186773|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||>0.016
91779867|NCT01929317|183439910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 2.|||0.3|-0.2|
91779868|NCT01929317|183439910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 4.|||0.4|-0.2|
91779869|NCT01929317|183439910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 6.|||0.3|-0.4|
91779870|NCT01929317|183439910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 8.|||0.3|-0.3|
91779871|NCT01929317|183439910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 12.|||0.6|-0.2|
91779872|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.8|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, On status.|||0.1|-1.8|
91779873|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.4|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, On status.|||0.1|-2.4|
91779874|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.6|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, On status.|||0.3|-2.6|
91586578|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|5.84|<|0.0001|TWO_SIDED|95.0|-41.8|-18.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 7||-18.8|-41.8|<0.0001
91586579|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|5.87||0.0069|TWO_SIDED|95.0|-27.7|-4.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 7||-4.5|-27.7|0.0069
91586580|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-40.1|STANDARD_ERROR_OF_MEAN|6.09|<|0.0001|TWO_SIDED|95.0|-52.1|-28.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-28.0|-52.1|<0.0001
91586581|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|6.01|<|0.0001|TWO_SIDED|95.0|-42.3|-18.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-18.5|-42.3|<0.0001
91586582|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|6.05||0.0194|TWO_SIDED|95.0|-26.2|-2.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-2.3|-26.2|0.0194
91586583|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-40.6|STANDARD_ERROR_OF_MEAN|6.35|<|0.0001|TWO_SIDED|95.0|-53.2|-28.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 9||-28.1|-53.2|<0.0001
91586584|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|6.27|<|0.0001|TWO_SIDED|95.0|-44.9|-20.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 9||-20.1|-44.9|<0.0001
91586585|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|6.3||0.0054|TWO_SIDED|95.0|-30.2|-5.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 9||-5.3|-30.2|0.0054
91586586|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-40.7|STANDARD_ERROR_OF_MEAN|6.46|<|0.0001|TWO_SIDED|95.0|-53.4|-27.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 10||-27.9|-53.4|<0.0001
91586587|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-35.1|STANDARD_ERROR_OF_MEAN|6.41|<|0.0001|TWO_SIDED|95.0|-47.8|-22.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 10||-22.5|-47.8|<0.0001
91647451|NCT02499406|183186774|SUPERIORITY||||||<|0.016||||||p value was calculated and found to be below the a priori threshold for significance, which was adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||<0.016
91586588|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|6.42||0.0009|TWO_SIDED|95.0|-34.4|-9.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 10||-9.1|-34.4|0.0009
91586589|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-40.9|STANDARD_ERROR_OF_MEAN|6.66|<|0.0001|TWO_SIDED|95.0|-54.1|-27.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 11||-27.8|-54.1|<0.0001
91586590|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-35.2|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|-48.3|-22.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 11||-22.1|-48.3|<0.0001
91647452|NCT02499406|183186775|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
91779875|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.8|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, On status.|||0.3|-2.8|
91779876|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, On status.|||0.7|-2.7|
91779877|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.8|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, Off status.|||0.5|-1.8|
91779878|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.6|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, Off status.|||0.8|-2.6|
91779879|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.8|1.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, Off status.|||1.0|-2.8|
91779880|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, Off status.|||1.8|-2.1|
91586591|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-18.2|STANDARD_ERROR_OF_MEAN|6.61||0.0067|TWO_SIDED|95.0|-31.2|-5.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 11||-5.1|-31.2|0.0067
91586592|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-41.3|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|-54.5|-28.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-28.2|-54.5|<0.0001
91586593|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-32.2|STANDARD_ERROR_OF_MEAN|6.63|<|0.0001|TWO_SIDED|95.0|-45.3|-19.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-19.1|-45.3|<0.0001
91586594|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|6.6||0.0279|TWO_SIDED|95.0|-27.6|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-1.6|-27.6|0.0279
91586595|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|95.0|-51.9|-25.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 13||-25.4|-51.9|<0.0001
91586596|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-33.7|STANDARD_ERROR_OF_MEAN|6.69|<|0.0001|TWO_SIDED|95.0|-46.7|-20.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 13||-20.5|-46.7|<0.0001
91586597|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.7|STANDARD_ERROR_OF_MEAN|6.65||0.0085|TWO_SIDED|95.0|-30.8|-4.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 13||-4.6|-30.8|0.0085
91586598|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-41.9|STANDARD_ERROR_OF_MEAN|6.85|<|0.0001|TWO_SIDED|95.0|-55.4|-28.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 14||-28.4|-55.4|<0.0001
91586599|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|6.84|<|0.0001|TWO_SIDED|95.0|-51.1|-24.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 14||-24.1|-51.1|<0.0001
91586600|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-21.4|STANDARD_ERROR_OF_MEAN|6.8||0.002|TWO_SIDED|95.0|-34.8|-8.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 14||-8.0|-34.8|0.0020
91647453|NCT02499406|183186776|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=14||Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessment||||<0.016
91647454|NCT02499406|183186777|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=10||Null hypothesis is no difference between baseline and this 6-month assessment.||||<0.016
91586601|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-42.7|STANDARD_ERROR_OF_MEAN|6.72|<|0.0001|TWO_SIDED|95.0|-55.9|-29.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 15||-29.4|-55.9|<0.0001
91586602|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-37.2|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|95.0|-50.4|-24.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 15||-24.0|-50.4|< 0.0001
91586603|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-21.4|STANDARD_ERROR_OF_MEAN|6.67||0.0016|TWO_SIDED|95.0|-34.5|-8.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 15||-8.2|-34.5|0.0016
91586604|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-41.6|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|-55.0|-28.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-28.3|-55.0|<0.0001
91647455|NCT02499406|183186778|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=11||Null hypothesis is no difference between baseline and this 9-month assessment.||||<0.016
91647456|NCT02499406|183186779|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||> 0.016
91647457|NCT02499406|183186780|SUPERIORITY||||||=|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=10||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||=.016
91708987|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.189||0.9601||95.0|-0.44|0.42|||ANOVA|||Difference from placebo (including Baseline), Day 8: 2 hours post-dose.||0.42|-0.44|0.9601
91708988|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.311||0.867||95.0|-0.64|0.74|||ANOVA|||Difference from placebo (including baseline), Day 8: 3 hours post-dose.||0.74|-0.64|0.8670
91586605|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-36.4|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|-49.7|-23.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-23.1|-49.7|<0.0001
91586606|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-18.4|STANDARD_ERROR_OF_MEAN|6.72||0.0067|TWO_SIDED|95.0|-31.7|-5.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-5.2|-31.7|0.0067
91586607|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-35.2|STANDARD_ERROR_OF_MEAN|7.0|<|0.0001|TWO_SIDED|95.0|-49.0|-21.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 17||-21.4|-49.0|<0.0001
91708989|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.393||0.9024||95.0|-0.94|0.84|||ANOVA|||Difference from placebo (including baseline), Day 8: 4 hours post-dose.||0.84|-0.94|0.9024
91586608|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-32.1|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|-46.0|-18.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 17||-18.1|-46.0|<0.0001
91586609|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.9|STANDARD_ERROR_OF_MEAN|6.98||0.0111|TWO_SIDED|95.0|-31.7|-4.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 17||-4.1|-31.7|0.0111
91779881|NCT01929317|183439911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, Off status.|||2.1|-2.2|
91779882|NCT01929317|183439912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 2.|||0.4|-0.7|
91779883|NCT01929317|183439912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 4.|||0.6|-0.7|
91586610|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|7.02|<|0.0001|TWO_SIDED|95.0|-43.8|-16.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-16.1|-43.8|<0.0001
91586611|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-26.6|STANDARD_ERROR_OF_MEAN|7.12||0.0003|TWO_SIDED|95.0|-40.6|-12.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-12.5|-40.6|0.0003
91779884|NCT01929317|183439912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 6.|||0.8|-0.7|
91779885|NCT01929317|183439912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 8.|||0.7|-0.7|
91779886|NCT01929317|183439912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 12.|||0.5|-0.9|
91779887|NCT01929317|183439925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.65|1.04|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 2."|||1.04|-1.65|
91779888|NCT01929317|183439925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-1.34|1.45|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 4."|||1.45|-1.34|
91586612|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|6.96||0.0445|TWO_SIDED|95.0|-27.8|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-0.4|-27.8|0.0445
91779889|NCT01929317|183439925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.95|1.24|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 6."|||1.24|-1.95|
91779890|NCT01929317|183439925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-2.44|0.75|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 8."|||0.75|-2.44|
91779891|NCT01929317|183439925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-2.73|0.58|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 12."|||0.58|-2.73|
91779892|NCT01929317|183439926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|95.0|-8.77|6.71|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 2."|||6.71|-8.77|
91779893|NCT01929317|183439926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-7.94|8.22|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 4."|||8.22|-7.94|
91779894|NCT01929317|183439926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78|||||TWO_SIDED|95.0|-12.06|6.49|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 6."|||6.49|-12.06|
91779895|NCT01929317|183439926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|||||TWO_SIDED|95.0|-14.06|5.14|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 8."|||5.14|-14.06|
91779896|NCT01929317|183439926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-15.92|3.96|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 12."|||3.96|-15.92|
91779897|NCT01929317|183439927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-1.07|1.21|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 2."|||1.21|-1.07|
91586613|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|7.06||0.0008|TWO_SIDED|95.0|-38.1|-10.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 19||-10.2|-38.1|0.0008
91779898|NCT01929317|183439927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-0.75|1.7|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 4."|||1.70|-0.75|
91779899|NCT01929317|183439927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.65|1.86|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 6."|||1.86|-0.65|
91779900|NCT01929317|183439927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.52|2.22|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 8."|||2.22|-0.52|
91779901|NCT01929317|183439927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-0.55|2.26|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 12."|||2.26|-0.55|
91779902|NCT01929317|183439928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.98|1.36|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 2."|||1.36|-0.98|
91779903|NCT01929317|183439928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.64|1.78|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 4."|||1.78|-0.64|
91708990|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.293||0.9708||95.0|-0.67|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 5 hours post-dose.||0.65|-0.67|0.9708
91586614|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|7.17||0.0027|TWO_SIDED|95.0|-36.0|-7.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 19||-7.7|-36.0|0.0027
91586615|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.05||0.0724|TWO_SIDED|95.0|-26.7|1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 19||1.2|-26.7|0.0724
91586616|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-21.6|STANDARD_ERROR_OF_MEAN|7.11||0.0028|TWO_SIDED|95.0|-35.7|-7.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-7.6|-35.7|0.0028
91586617|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|7.22||0.0158|TWO_SIDED|95.0|-31.9|-3.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-3.3|-31.9|0.0158
91586618|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.06||0.1468|TWO_SIDED|95.0|-24.2|3.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||3.6|-24.2|0.1468
91586619|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|7.21||0.0167|TWO_SIDED|95.0|-31.7|-3.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 21||-3.2|-31.7|0.0167
91586620|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|7.29||0.0242|TWO_SIDED|95.0|-31.0|-2.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 21||-2.2|-31.0|0.0242
91586621|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|7.08||0.224|TWO_SIDED|95.0|-22.6|5.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 21||5.3|-22.6|0.2240
91586622|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|7.3||0.031|TWO_SIDED|95.0|-30.3|-1.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 22||-1.5|-30.3|0.0310
91586623|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|7.33||0.0437|TWO_SIDED|95.0|-29.4|-0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 22||-0.4|-29.4|0.0437
91586624|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|7.12||0.4123|TWO_SIDED|95.0|-19.9|8.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 22||8.2|-19.9|0.4123
91586625|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|7.46||0.0808|TWO_SIDED|95.0|-27.8|1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 23||1.6|-27.8|0.0808
91586626|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|7.45||0.1064|TWO_SIDED|95.0|-26.8|2.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 23||2.6|-26.8|0.1064
91586627|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|7.24||0.4366|TWO_SIDED|95.0|-19.9|8.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 23||8.6|-19.9|0.4366
91586628|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|7.39||0.0644|TWO_SIDED|95.0|-28.3|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 24||0.8|-28.3|0.0644
91708991|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.395||0.1078||95.0|-1.62|0.19|||ANOVA|||Difference from placebo (including Baseline), Day 8: 6 hours post-dose.||0.19|-1.62|0.1078
91708992|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.419||0.446||95.0|-1.28|0.61|||ANOVA|||Difference from placebo (including Baseline), Day 8: 8 hours post-dose.||0.61|-1.28|0.4460
91708993|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.394||0.5266||95.0|-1.13|0.62|||ANOVA|||Difference from placebo (including Baseline), Day 8: 10 hours post-dose.||0.62|-1.13|0.5266
91708994|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.273||0.029||95.0|-1.29|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 8: 12 hours post-dose.||-0.08|-1.29|0.0290
91647458|NCT02499406|183186781|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
91647459|NCT00948025|183186846|OTHER|Mann-Whitney U test was used to derive p-values.||||||0.0433||||||"1. a priori threshold for statistical significance set at p\<0.05.~2. the p-value was not adjusted for multiple comparisons."|Wilcoxon (Mann-Whitney)|||"1. P-value comparing static 2-point discrimination per visit derived from mixed linear modeling of longitudinal data.~2. P-Value is based on Mann-Whitney U test."||||0.0433
91647460|NCT02292433|183186890|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.96|STANDARD_ERROR_OF_MEAN|4.841||0.0032|TWO_SIDED|90.0|-28.93|-10.98|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-10.98|-28.93|0.0032
91647461|NCT02292433|183186890|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.06|STANDARD_ERROR_OF_MEAN|3.172|<|0.0001|TWO_SIDED|90.0|-46.77|-35.35|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-35.35|-46.77|<0.0001
91647462|NCT02292433|183186891|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.18|STANDARD_ERROR_OF_MEAN|2.851||0.0006|TWO_SIDED|90.0|-17.16|-7.21|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-7.21|-17.16|0.0006
91647463|NCT02292433|183186891|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.81|STANDARD_ERROR_OF_MEAN|2.821|<|0.0001|TWO_SIDED|90.0|-30.73|-20.88|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-20.88|-30.73|<0.0001
91647464|NCT02292433|183186892|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.521|STANDARD_ERROR_OF_MEAN|0.7237||0.0447|TWO_SIDED|90.0|-2.752|-0.29|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.290|-2.752|0.0447
91647465|NCT02292433|183186892|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.949|STANDARD_ERROR_OF_MEAN|0.7249||0.0119|TWO_SIDED|90.0|-3.183|-0.716|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.716|-3.183|0.0119
91647466|NCT02292433|183186892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.967|STANDARD_ERROR_OF_MEAN|2.3324||0.6873|TWO_SIDED|90.0|-5.195|3.261|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||3.261|-5.195|0.6873
91647467|NCT02292433|183186892|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.439|STANDARD_ERROR_OF_MEAN|0.9533||0.0659|TWO_SIDED|90.0|-4.502|-0.377|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.377|-4.502|0.0659
91647468|NCT02292433|183186892|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.358|STANDARD_ERROR_OF_MEAN|1.5994||0.4031|TWO_SIDED|90.0|-4.079|1.363|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||1.363|-4.079|0.4031
91647469|NCT02292433|183186892|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.766|STANDARD_ERROR_OF_MEAN|1.5951||0.0254|TWO_SIDED|90.0|-6.479|-1.052|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-1.052|-6.479|0.0254
91647470|NCT02292433|183186893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.069||0.0067|TWO_SIDED|90.0|-0.33|-0.09|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.09|-0.33|0.0067
91779904|NCT01929317|183439928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-0.71|1.84|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 6."|||1.84|-0.71|
91779905|NCT01929317|183439928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-0.47|2.39|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 8."|||2.39|-0.47|
91779906|NCT01929317|183439928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.63|2.33|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 12."|||2.33|-0.63|
91779907|NCT02205736|183439986|SUPERIORITY|||||||0.8084||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8084
91647471|NCT02292433|183186893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.071||0.0282|TWO_SIDED|90.0|-0.29|-0.05|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.05|-0.29|0.0282
91779908|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91586629|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|7.41||0.0633|TWO_SIDED|95.0|-28.5|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 24||0.8|-28.5|0.0633
91586630|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|7.23||0.4775|TWO_SIDED|95.0|-19.4|9.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 24||9.1|-19.4|0.4775
91586631|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.33||0.1106|TWO_SIDED|95.0|-26.2|2.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 25||2.7|-26.2|0.1106
91586632|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|7.32||0.1043|TWO_SIDED|95.0|-26.4|2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 25||2.5|-26.4|0.1043
91586633|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|7.19||0.563|TWO_SIDED|95.0|-18.4|10.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 25||10.0|-18.4|0.5630
91586634|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.6|STANDARD_ERROR_OF_MEAN|7.26||0.0629|TWO_SIDED|95.0|-27.9|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 26||0.7|-27.9|0.0629
91586635|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|7.34||0.0523|TWO_SIDED|95.0|-28.8|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 26||0.1|-28.8|0.0523
91586636|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.15||0.442|TWO_SIDED|95.0|-19.6|8.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 26||8.6|-19.6|0.4420
91586637|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.19||0.0908|TWO_SIDED|95.0|-26.4|2.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 27||2.0|-26.4|0.0908
91779909|NCT02205736|183439986|SUPERIORITY|||||||0.0036||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0036
91779910|NCT02205736|183439986|SUPERIORITY|||||||0.0033||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0033
91779911|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91779912|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91586638|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|7.32||0.0688|TWO_SIDED|95.0|-27.9|1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 27||1.0|-27.9|0.0688
91586639|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.17||0.2802|TWO_SIDED|95.0|-21.9|6.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 27||6.4|-21.9|0.2802
91779913|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91586640|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.24||0.0337|TWO_SIDED|95.0|-29.8|-1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 28||-1.2|-29.8|0.0337
91708995|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.531||0.183||95.0|-2.01|0.45|||ANOVA|||Difference from placebo (including Baseline), Day 8: 24 hours post-dose.||0.45|-2.01|0.1830
91708996|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.406||0.9884||95.0|-0.9|0.91|||ANOVA|||Difference from placebo (including Baseline), Day 8: 36 hours post-dose.||0.91|-0.90|0.9884
91708997|NCT00978341|183311315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.354||0.8082||95.0|-0.87|0.69|||ANOVA|||Difference from placebo (including Baseline), Day 8: 48 hours post-dose.||0.69|-0.87|0.8082
91708998|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.714||0.2101||95.0|-2.39|0.55|||ANOVA|||Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models.||0.55|-2.39|0.2101
91708999|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.623||0.1065||95.0|-2.33|0.24|||ANOVA|||Difference from placebo (including baseline); Day 3.||0.24|-2.33|0.1065
91709000|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0697||95.0|-1.11|0.05|||ANOVA|||Difference from placebo (including baseline); Day 4.||0.05|-1.11|0.0697
91709001|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.65||0.4589||95.0|-1.83|0.85|||ANOVA|||Difference from placebo; Day 5.||0.85|-1.83|0.4589
91709002|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.742||0.1326||95.0|-2.69|0.38|||ANOVA|||Difference from placebo; Day 6.||0.38|-2.69|0.1326
91709003|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.638||0.282||95.0|-2.45|0.9|||ANOVA|||Difference from placebo (including baseline); Day 7.||0.90|-2.45|0.2820
91709004|NCT00978341|183311316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.356||0.0108||95.0|-2.21|-0.44|||ANOVA|||Difference from placebo (including baseline); Day 8.||-0.44|-2.21|0.0108
91709005|NCT00978341|183311317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|19.06||0.9068||95.0|-41.78|37.27|||ANOVA|||Difference from placebo; Day 1: 4 hours post-dose (including Baseline).||37.27|-41.78|0.9068
91709006|NCT00978341|183311317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|15.813||0.7807||95.0|-30.53|39.57|||ANOVA|||Difference from placebo; Day 8: pre-dose (including Baseline).||39.57|-30.53|0.7807
91709007|NCT00978341|183311317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.51|STANDARD_ERROR_OF_MEAN|17.526||0.2293||95.0|-61.79|16.78|||ANOVA|||Difference from placebo; Day 8: 4 hours post-dose (including Baseline).||16.78|-61.79|0.2293
91709008|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.386||0.3774||95.0|-0.54|1.27|||ANOVA|||Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose.||1.27|-0.54|0.3774
91586641|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|7.28||0.0673|TWO_SIDED|95.0|-27.8|1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 28||1.0|-27.8|0.0673
91586642|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|7.27||0.3564|TWO_SIDED|95.0|-21.1|7.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 28||7.6|-21.1|0.3564
91586643|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.6|STANDARD_ERROR_OF_MEAN|7.08||0.0558|TWO_SIDED|95.0|-27.6|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 29||0.3|-27.6|0.0558
91586644|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|7.16||0.0471|TWO_SIDED|95.0|-28.5|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 29||-0.2|-28.5|0.0471
91586645|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|7.03||0.4101|TWO_SIDED|95.0|-19.7|8.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 29||8.1|-19.7|0.4101
91586646|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|7.16||0.0287|TWO_SIDED|95.0|-29.9|-1.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 30||-1.7|-29.9|0.0287
91586647|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|7.24||0.0427|TWO_SIDED|95.0|-29.1|-0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 30||-0.5|-29.1|0.0427
91586648|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|7.1||0.2828|TWO_SIDED|95.0|-21.7|6.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 30||6.4|-21.7|0.2828
91647472|NCT02292433|183186893|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.118||0.7877|TWO_SIDED|90.0|-0.18|0.25|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.18|0.7877
91647473|NCT02292433|183186893|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.156||0.5064|TWO_SIDED|90.0|-0.17|0.39|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.39|-0.17|0.5064
91586649|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|7.12||0.0294|TWO_SIDED|95.0|-29.7|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 31||-1.6|-29.7|0.0294
91586650|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|7.15||0.0636|TWO_SIDED|95.0|-27.5|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 31||0.8|-27.5|0.0636
91586651|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|7.02||0.3812|TWO_SIDED|95.0|-20.0|7.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 31||7.7|-20.0|0.3812
91586652|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|7.06||0.027|TWO_SIDED|95.0|-29.7|-1.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||-1.8|-29.7|0.0270
91586653|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|7.04||0.0679|TWO_SIDED|95.0|-26.9|1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||1.0|-26.9|0.0679
91647474|NCT02292433|183186893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.293||0.4072|TWO_SIDED|90.0|-0.75|0.25|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.75|0.4072
91586654|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.0||0.4452|TWO_SIDED|95.0|-19.2|8.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||8.5|-19.2|0.4452
91779914|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91586655|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.08||0.0467|TWO_SIDED|95.0|-28.2|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 33||-0.2|-28.2|0.0467
91586656|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.01||0.0829|TWO_SIDED|95.0|-26.1|1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 33||1.6|-26.1|0.0829
91586657|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.89||0.5263|TWO_SIDED|95.0|-18.0|9.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 33||9.2|-18.0|0.5263
91586658|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|7.19||0.021|TWO_SIDED|95.0|-31.0|-2.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 34||-2.6|-31.0|0.0210
91586659|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|7.17||0.0623|TWO_SIDED|95.0|-27.6|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 34||0.7|-27.6|0.0623
91586660|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|7.08||0.4899|TWO_SIDED|95.0|-18.9|9.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 34||9.1|-18.9|0.4899
91586661|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|7.14||0.0281|TWO_SIDED|95.0|-29.9|-1.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 35||-1.7|-29.9|0.0281
91586662|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|7.08||0.1318|TWO_SIDED|95.0|-24.7|3.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 35||3.3|-24.7|0.1318
91586663|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|6.99||0.4458|TWO_SIDED|95.0|-19.1|8.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 35||8.5|-19.1|0.4458
91586664|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|7.11||0.0229|TWO_SIDED|95.0|-30.4|-2.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 36||-2.3|-30.4|0.0229
91586665|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.11||0.0978|TWO_SIDED|95.0|-25.9|2.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 36||2.2|-25.9|0.0978
91586666|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|6.93||0.3792|TWO_SIDED|95.0|-19.8|7.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 36||7.6|-19.8|0.3792
91586667|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|7.22||0.029|TWO_SIDED|95.0|-30.2|-1.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 37||-1.7|-30.2|0.0290
91586668|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|7.15||0.1306|TWO_SIDED|95.0|-25.0|3.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 37||3.3|-25.0|0.1306
91586669|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|6.99||0.3923|TWO_SIDED|95.0|-19.8|7.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 37||7.8|-19.8|0.3923
91586670|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|7.19||0.0265|TWO_SIDED|95.0|-30.3|-1.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 38||-1.9|-30.3|0.0265
91647475|NCT02292433|183186893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.295||0.1422|TWO_SIDED|90.0|-0.95|0.06|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.06|-0.95|0.1422
91647476|NCT03555890|183186901|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.975|||||TWO_SIDED|90.0|0.948|1.003||||||||1.003|0.948|
91647477|NCT03555890|183186902|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.978|||||TWO_SIDED|90.0|0.958|0.998||||||||0.998|0.958|
91647478|NCT03555890|183186903|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.934|||||TWO_SIDED|90.0|0.875|0.998||||||||0.998|0.875|
91647479|NCT03555890|183186904|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.857|||||TWO_SIDED|90.0|0.815|0.902||||||||0.902|0.815|
91647480|NCT03372369|183186965|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.||||<0.0001
91647481|NCT03372369|183186965|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.||||<0.0001
91647482|NCT03372369|183186965|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.||||<0.0001
91647483|NCT03372369|183186966|SUPERIORITY||||||<|0.001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.||||<0.001
91647484|NCT03372369|183186966|SUPERIORITY||||||<|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.||||<0.01
91647485|NCT03372369|183186966|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.||||>0.01
91647486|NCT03372369|183186967|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
91779915|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91586671|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|7.12||0.1456|TWO_SIDED|95.0|-24.5|3.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 38||3.6|-24.5|0.1456
91586672|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|6.96||0.5138|TWO_SIDED|95.0|-18.3|9.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 38||9.2|-18.3|0.5138
91586673|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|7.08||0.0265|TWO_SIDED|95.0|-29.8|-1.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 39||-1.9|-29.8|0.0265
91586674|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|7.05||0.0986|TWO_SIDED|95.0|-25.7|2.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 39||2.2|-25.7|0.0986
91586675|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|6.91||0.36|TWO_SIDED|95.0|-20.0|7.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 39||7.3|-20.0|0.3600
91586676|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.09||0.0303|TWO_SIDED|95.0|-29.5|-1.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 40||-1.5|-29.5|0.0303
91586677|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.07||0.0979|TWO_SIDED|95.0|-25.7|2.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 40||2.2|-25.7|0.0979
91586678|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|6.92||0.3664|TWO_SIDED|95.0|-19.9|7.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 40||7.4|-19.9|0.3664
91586679|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|7.04||0.0806|TWO_SIDED|95.0|-26.3|1.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 41||1.5|-26.3|0.0806
91586680|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|7.01||0.226|TWO_SIDED|95.0|-22.4|5.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 41||5.3|-22.4|0.2260
91586681|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|6.92||0.3835|TWO_SIDED|95.0|-19.7|7.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 41||7.6|-19.7|0.3835
91586682|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|6.9||0.0594|TWO_SIDED|95.0|-26.7|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 42||0.5|-26.7|0.0594
91586683|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|6.91||0.2189|TWO_SIDED|95.0|-22.2|5.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 42||5.1|-22.2|0.2189
91586684|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|6.79||0.5238|TWO_SIDED|95.0|-17.8|9.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 42||9.1|-17.8|0.5238
91586685|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|6.92||0.1204|TWO_SIDED|95.0|-24.5|2.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 43||2.9|-24.5|0.1204
91709009|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.215||0.4153||95.0|-0.33|0.7|||ANOVA|||Difference from placebo (including Baseline); Day 1: 1 hour post-dose.||0.70|-0.33|0.4153
91586686|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|6.84||0.1129|TWO_SIDED|95.0|-24.4|2.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 43||2.6|-24.4|0.1129
91586687|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|6.81||0.3911|TWO_SIDED|95.0|-19.3|7.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 43||7.6|-19.3|0.3911
91586688|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|6.93||0.0784|TWO_SIDED|95.0|-26.0|1.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 44||1.4|-26.0|0.0784
91586689|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|6.9||0.3046|TWO_SIDED|95.0|-20.7|6.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 44||6.5|-20.7|0.3046
91586690|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.82||0.5205|TWO_SIDED|95.0|-17.9|9.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 44||9.1|-17.9|0.5205
91586691|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|6.74||0.0388|TWO_SIDED|95.0|-27.3|-0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 45||-0.7|-27.3|0.0388
91586692|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|6.75||0.1105|TWO_SIDED|95.0|-24.2|2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 45||2.5|-24.2|0.1105
91586693|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|6.68||0.7039|TWO_SIDED|95.0|-15.7|10.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 45||10.7|-15.7|0.7039
91586694|NCT03816891|183063658|SUPERIORITY||ls|-11.7|STANDARD_ERROR_OF_MEAN|6.82||0.0885|TWO_SIDED|95.0|-25.2|1.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 46||1.8|-25.2|0.0885
91586695|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|6.79||0.1535|TWO_SIDED|95.0|-23.1|3.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 46||3.7|-23.1|0.1535
91586696|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.76||0.8975|TWO_SIDED|95.0|-14.2|12.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 46||12.5|-14.2|0.8975
91586697|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|6.96||0.0674|TWO_SIDED|95.0|-26.6|0.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 47||0.9|-26.6|0.0674
91779916|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91779917|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91779918|NCT02205736|183439986|SUPERIORITY|||||||0.0124||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0124
91779919|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91586698|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|0.3025||0.3025|TWO_SIDED|95.0|-20.8|6.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 47||6.5|-20.8|0.3025
91586699|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.9||0.8964|TWO_SIDED|95.0|-14.5|12.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 47||12.7|-14.5|0.8964
91586700|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|6.79||0.0633|TWO_SIDED|95.0|-26.1|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||0.7|-26.1|0.0633
91586701|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|6.81||0.1665|TWO_SIDED|95.0|-22.9|4.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||4.0|-22.9|0.1665
91586702|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|6.78||0.7748|TWO_SIDED|95.0|-15.3|11.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||11.4|-15.3|0.7748
91586703|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|7.04||0.1239|TWO_SIDED|95.0|-24.8|3.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 49||3.0|-24.8|0.1239
91586704|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|7.17||0.3647|TWO_SIDED|95.0|-20.7|7.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 49||7.6|-20.7|0.3647
91586705|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|7.2||0.8056|TWO_SIDED|95.0|-12.5|16.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 49||16.0|-12.5|0.8056
91586706|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|7.35||0.1079|TWO_SIDED|95.0|-26.4|2.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 50||2.6|-26.4|0.1079
91586707|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|7.37||0.4174|TWO_SIDED|95.0|-20.6|8.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 50||8.6|-20.6|0.4174
91586708|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|7.39||0.7815|TWO_SIDED|95.0|-16.7|12.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 50||12.6|-16.7|0.7815
91586709|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.22||0.0802|TWO_SIDED|95.0|-27.0|1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 51||1.6|-27.0|0.0802
91647487|NCT03372369|183186967|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
91586710|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|7.48||0.1386|TWO_SIDED|95.0|-25.9|3.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 51||3.6|-25.9|0.1386
91586711|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|7.26||0.5101|TWO_SIDED|95.0|-19.2|9.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 51||9.6|-19.2|0.5101
91586712|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|7.25||0.0972|TWO_SIDED|95.0|-26.5|2.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||2.2|-26.5|0.0972
91779920|NCT02205736|183439986|SUPERIORITY|||||||0.0588||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0588
91779921|NCT02205736|183439986|SUPERIORITY|||||||0.0143||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0143
91779922|NCT02205736|183439986|SUPERIORITY|||||||0.1025||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1025
91779923|NCT02205736|183439986|SUPERIORITY|||||||0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0001
91779924|NCT02205736|183439986|SUPERIORITY|||||||0.1138||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1138
91779925|NCT02205736|183439986|SUPERIORITY|||||||0.0011||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0011
91779926|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
91779927|NCT02205736|183439986|SUPERIORITY|||||||0.0522||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0522
91779928|NCT02205736|183439986|SUPERIORITY|||||||0.8185||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8185
91586713|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|7.61||0.4454|TWO_SIDED|95.0|-20.9|9.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||9.2|-20.9|0.4454
91586714|NCT03816891|183063658|SUPERIORITY||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|7.28||0.7638|TWO_SIDED|95.0|-12.2|16.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed ( ≥ 10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||16.6|-12.2|0.7638
91586715|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.95||||0.5673|TWO_SIDED|95.0|0.18|20.86||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 1||20.86|0.18|0.5673
91779929|NCT02205736|183439986|SUPERIORITY|||||||0.0005||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0005
91586716|NCT03816891|183063659|SUPERIORITY|||||||0.3173||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 1||||0.3173
91779930|NCT02205736|183439986|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Subjects recorded True/False answers to Q25 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The contingency table of 329 responses to Q25 displayed the following: N=260 Correct at Baseline and Correct at Post-Intervention (79.0%), N=7 Correct at Baseline and Incorrect at Post-Intervention (2.1%), N=49 Incorrect at Baseline and Correct at Post-Intervention (14.9%), N=13 Incorrect at Baseline and Incorrect at Post-Intervention (4.0%).||||<.0001
91586717|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.57||||0.7668|TWO_SIDED|95.0|0.08|29.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 1||29.41|0.08|0.7668
91586718|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.26||||0.052|TWO_SIDED|95.0|0.76|51.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 2||51.82|0.76|0.0520
91586719|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.2||||0.5457|TWO_SIDED|95.0|0.17|28.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 2||28.14|0.17|0.5457
91586720|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.77||||0.1053|TWO_SIDED|95.0|0.57|79.79||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 2||79.79|0.57|0.1053
91586721|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|11.3||||0.0043|TWO_SIDED|95.0|1.45|88.33||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 3||88.33|1.45|0.0043
91586722|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.06|18.08||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 3||18.08|0.06|1.0000
91586723|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.81||||0.1006|TWO_SIDED|95.0|0.59|79.12||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 3||79.12|0.59|0.1006
91586724|NCT03816891|183063659|SUPERIORITY||||||<|0.0001||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 4||||<0.0001
91586725|NCT03816891|183063659|SUPERIORITY|||||||0.0193||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 4||||0.0193
91586726|NCT03816891|183063659|SUPERIORITY|||||||0.0463||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 4||||0.0463
91586727|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|15.95||||0.0002|TWO_SIDED|95.0|2.26|112.81||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 5||112.81|2.26|0.0002
91586728|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|5.82||||0.0917|TWO_SIDED|95.0|0.62|54.99||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 5||54.99|0.62|0.0917
91586729|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.81||||0.1006|TWO_SIDED|95.0|0.59|79.12||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 5||79.12|0.59|0.1006
91586730|NCT03816891|183063659|SUPERIORITY|||||||0.0001||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 6||||0.0001
91586731|NCT03816891|183063659|SUPERIORITY|||||||0.0035||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 6||||0.0035
91586732|NCT03816891|183063659|SUPERIORITY|||||||0.0269||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 6||||0.0269
91586733|NCT03816891|183063659|SUPERIORITY||||||<|0.0001||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 7||||<0.0001
91586734|NCT03816891|183063659|SUPERIORITY|||||||0.0009||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 7||||0.0009
91586735|NCT03816891|183063659|SUPERIORITY|||||||0.0098||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 7||||0.0098
91586736|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|28.79|||<|0.0001|TWO_SIDED|95.0|3.21|258.26||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 8||258.26|3.21|<0.0001
91586737|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|10.16||||0.0074|TWO_SIDED|95.0|1.31|79.08||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 8||79.08|1.31|0.0074
91586738|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|3.09||||0.2466|TWO_SIDED|95.0|0.37|26.06||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 8||26.06|0.37|0.2466
91586739|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|11.56||||0.0005|TWO_SIDED|95.0|2.37|56.49||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 9||56.49|2.37|0.0005
91586740|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.06||||0.014|TWO_SIDED|95.0|1.25|29.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 9||29.37|1.25|0.0140
91586741|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0823|TWO_SIDED|95.0|0.76|18.07||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 9||18.07|0.76|0.0823
91586742|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|9.38||||0.0002|TWO_SIDED|95.0|2.51|35.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 10||35.02|2.51|0.0002
91586743|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|4.65||||0.0197|TWO_SIDED|95.0|1.2|18.1||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 10||18.10|1.20|0.0197
91779931|NCT02205736|183439987|SUPERIORITY|||||||0.2482||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2482
91586744|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0392|TWO_SIDED|95.0|0.99|15.69||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 10||15.69|0.99|0.0392
91586745|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|13.93|||<|0.0001|TWO_SIDED|95.0|3.18|61.09||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 11||61.09|3.18|<0.0001
91586746|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|8.54||||0.0036|TWO_SIDED|95.0|1.72|42.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 11||42.37|1.72|0.0036
91586747|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0638|TWO_SIDED|95.0|0.81|24.23||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 11||24.23|0.81|0.0638
91586748|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|8.56||||0.0005|TWO_SIDED|95.0|2.28|32.07||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 12||32.07|2.28|0.0005
91586749|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0379|TWO_SIDED|95.0|1.03|16.19||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 12||16.19|1.03|0.0379
91586750|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.01||||0.3367|TWO_SIDED|95.0|0.46|8.78||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 12||8.78|0.46|0.3367
91586751|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|9.73||||0.0003|TWO_SIDED|95.0|2.46|38.51||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 13||38.51|2.46|0.0003
91586752|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.72||||0.0017|TWO_SIDED|95.0|1.82|24.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 13||24.75|1.82|0.0017
91586753|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.93||||0.0831|TWO_SIDED|95.0|0.79|10.83||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 13||10.83|0.79|0.0831
91586754|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|8.51||||0.0001|TWO_SIDED|95.0|2.58|28.06||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 14||28.06|2.58|0.0001
91586755|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0087|TWO_SIDED|95.0|1.41|15.94||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 14||15.94|1.41|0.0087
91586756|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1361|TWO_SIDED|95.0|0.73|9.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 14||9.37|0.73|0.1361
91586757|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|11.72|||<|0.0001|TWO_SIDED|95.0|3.08|44.56||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 15||44.56|3.08|<0.0001
91586758|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|5.74||||0.0058|TWO_SIDED|95.0|1.51|21.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 15||21.75|1.51|0.0058
91586759|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|3.16||||0.1036|TWO_SIDED|95.0|0.77|13.03||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 15||13.03|0.77|0.1036
91586760|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|71.24|||<|0.0001|TWO_SIDED|95.0|5.35|948.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 16||948.31|5.35|<0.0001
91586761|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|11.62||||0.0019|TWO_SIDED|95.0|1.62|83.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 16||83.47|1.62|0.0019
91586762|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|8.48||||0.0117|TWO_SIDED|95.0|1.14|68.26||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 16||68.26|1.14|0.0117
91586763|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|6.97|||<|0.0001|TWO_SIDED|95.0|2.46|19.76||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 17||19.76|2.46|<0.0001
91586764|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|3.64||||0.0173|TWO_SIDED|95.0|1.23|10.74||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 17||10.74|1.23|0.0173
91586765|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2598|TWO_SIDED|95.0|0.63|6.0||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 17||6.00|0.63|0.2598
91586766|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|5.09||||0.0003|TWO_SIDED|95.0|1.98|13.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 18||13.11|1.98|0.0003
91586767|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0402|TWO_SIDED|95.0|1.05|8.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 18||8.02|1.05|0.0402
91586768|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.97||||0.2003|TWO_SIDED|95.0|0.7|5.51||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 18||5.51|0.70|0.2003
91586769|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|3.84||||0.0034|TWO_SIDED|95.0|1.52|9.67||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 19||9.67|1.52|0.0034
91586770|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0749|TWO_SIDED|95.0|0.92|5.8||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 19||5.80|0.92|0.0749
91586771|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1248|TWO_SIDED|95.0|0.82|5.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 19||5.02|0.82|0.1248
91779932|NCT02205736|183439987|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
91779933|NCT02205736|183439987|SUPERIORITY|||||||0.005||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0050
91779934|NCT02205736|183439987|SUPERIORITY|||||||0.0423||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0423
91779935|NCT02205736|183439987|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
91779936|NCT02205736|183439987|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
91779937|NCT02205736|183439987|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
91779938|NCT02205736|183439987|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
91779939|NCT02205736|183439987|SUPERIORITY|||||||0.7456||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.7456
91586772|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0278|TWO_SIDED|95.0|1.09|6.03||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 20||6.03|1.09|0.0278
91709010|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48||||0.147||95.0|-0.23|1.2|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||1.20|-0.23|0.1470
91779940|NCT02205736|183439987|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
91521224|NCT02954354|182917043|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
91586773|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7001|TWO_SIDED|95.0|0.48|2.97||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 20||2.97|0.48|0.7001
91586774|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7844|TWO_SIDED|95.0|0.46|2.84||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 20||2.84|0.46|0.7844
91709011|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.3||0.1862||95.0|-1.18|0.29|||ANOVA|||Difference from placebo (including Baseline); Day 1: 3 hours post-dose.||0.29|-1.18|0.1862
91779941|NCT02205736|183439987|SUPERIORITY|||||||0.0028||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0028
91779942|NCT02205736|183439987|SUPERIORITY|||||||0.0707||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0707
91709012|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8321||95.0|-0.45|0.55|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.55|-0.45|0.8321
91709013|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.269||0.4251||95.0|-0.42|0.88|||ANOVA|||Difference from placebo (including Baseline); Day 1: 5 hours post-dose.||0.88|-0.42|0.4251
91709014|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.6394||95.0|-0.53|0.8|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.80|-0.53|0.6394
91709015|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.302||0.9964||95.0|-0.68|0.68|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.68|-0.68|0.9964
91779943|NCT02205736|183439987|SUPERIORITY|||||||0.0026||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0026
91779944|NCT02205736|183439987|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
91779945|NCT02205736|183439987|SUPERIORITY|||||||0.6547||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.6547
91586775|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0249|TWO_SIDED|95.0|1.12|6.44||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 21||6.44|1.12|0.0249
91586776|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0303|TWO_SIDED|95.0|1.09|6.54||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 21||6.54|1.09|0.0303
91586777|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2601|TWO_SIDED|95.0|0.69|4.12||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 21||4.12|0.69|0.2601
91586778|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0691|TWO_SIDED|95.0|0.94|5.46||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 22||5.46|0.94|0.0691
91586779|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0538|TWO_SIDED|95.0|0.98|5.52||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 22||5.52|0.98|0.0538
91586780|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6258|TWO_SIDED|95.0|0.52|2.94||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 22||2.94|0.52|0.6258
91586781|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7407|TWO_SIDED|95.0|0.5|2.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 23||2.63|0.50|0.7407
91586782|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5218|TWO_SIDED|95.0|0.57|3.06||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 23||3.06|0.57|0.5218
91586783|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9855|TWO_SIDED|95.0|0.43|2.34||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 23||2.34|0.43|0.9855
91586784|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7407|TWO_SIDED|95.0|0.5|2.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 24||2.68|0.50|0.7407
91586785|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.78||||0.1843|TWO_SIDED|95.0|0.76|4.17||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 24||4.17|0.76|0.1843
91586786|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6364|TWO_SIDED|95.0|0.54|2.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 24||2.77|0.54|0.6364
91586787|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9206|TWO_SIDED|95.0|0.45|2.4||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 25||2.40|0.45|0.9206
91586788|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6473|TWO_SIDED|95.0|0.52|2.87||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 25||2.87|0.52|0.6473
91586789|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8733|TWO_SIDED|95.0|0.4|2.15||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 25||2.15|0.40|0.8733
91586790|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.16||||0.738|TWO_SIDED|95.0|0.5|2.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 26||2.68|0.50|0.7380
91709016|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.324||0.3638||95.0|-0.47|1.11|||ANOVA|||Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose.||1.11|-0.47|0.3638
91586791|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3768|TWO_SIDED|95.0|0.63|3.43||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 26||3.43|0.63|0.3768
91586792|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9363|TWO_SIDED|95.0|0.45|2.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (\>= 10 years vs. \< 10 years).|Cochran-Mantel-Haenszel|||Week 26||2.41|0.45|0.9363
91586793|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4558|TWO_SIDED|95.0|0.6|3.18||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 27||3.18|0.60|0.4558
91586794|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4883|TWO_SIDED|95.0|0.57|3.24||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 27||3.24|0.57|0.4883
91521225|NCT02954354|182917043|SUPERIORITY|||||||0.7044||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.7044
91586795|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.84||||0.697|TWO_SIDED|95.0|0.36|1.96||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 27||1.96|0.36|0.6970
91586796|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4601|TWO_SIDED|95.0|0.6|3.16||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 28||3.16|0.60|0.4601
91586797|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3758|TWO_SIDED|95.0|0.63|3.51||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 28||3.51|0.63|0.3758
91586798|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7248|TWO_SIDED|95.0|0.36|2.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 28||2.02|0.36|0.7248
91779946|NCT02205736|183439987|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
91779947|NCT02205736|183439987|SUPERIORITY|||||||0.285||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2850
91779948|NCT02205736|183439987|SUPERIORITY|||||||0.0606||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0606
91779949|NCT02205736|183439987|SUPERIORITY|||||||0.0045||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0045
91779950|NCT02205736|183439987|SUPERIORITY|||||||0.9068||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.9068
91779951|NCT02205736|183439987|SUPERIORITY|||||||0.4142||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.4142
91779952|NCT02205736|183439987|SUPERIORITY|||||||0.5637||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.5637
91586799|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.37||||0.455|TWO_SIDED|95.0|0.6|3.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 29||3.11|0.60|0.4550
91586800|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3672|TWO_SIDED|95.0|0.64|3.35||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 29||3.35|0.64|0.3672
91586801|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.05||||0.912|TWO_SIDED|95.0|0.47|2.35||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 29||2.35|0.47|0.9120
91779953|NCT02205736|183439987|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 23 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
91586802|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3506|TWO_SIDED|95.0|0.65|3.35||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 30||3.35|0.65|0.3506
91586803|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.35||||0.4969|TWO_SIDED|95.0|0.58|3.16||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 30||3.16|0.58|0.4969
91586804|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9265|TWO_SIDED|95.0|0.42|2.19||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 30||2.19|0.42|0.9265
91586805|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.65||||0.244|TWO_SIDED|95.0|0.72|3.79||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 31||3.79|0.72|0.2440
91586806|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4829|TWO_SIDED|95.0|0.59|3.15||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 31||3.15|0.59|0.4829
91586807|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7382|TWO_SIDED|95.0|0.51|2.61||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 31||2.61|0.51|0.7382
91586808|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8833|TWO_SIDED|95.0|0.47|2.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.41|0.47|0.8833
91586809|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9385|TWO_SIDED|95.0|0.44|2.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.41|0.44|0.9385
91586810|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5975|TWO_SIDED|95.0|0.35|1.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||1.82|0.35|0.5975
91586811|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4491|TWO_SIDED|95.0|0.61|3.13||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 33||3.13|0.61|0.4491
91586812|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.71||||0.2348|TWO_SIDED|95.0|0.72|4.05||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 33||4.05|0.72|0.2348
91586813|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.05||||0.9087|TWO_SIDED|95.0|0.46|2.38||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 33||2.38|0.46|0.9087
91586814|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3349|TWO_SIDED|95.0|0.66|3.42||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 34||3.42|0.66|0.3349
91586815|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4806|TWO_SIDED|95.0|0.58|3.17||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 34||3.17|0.58|0.4806
91586816|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8998|TWO_SIDED|95.0|0.42|2.15||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 34||2.15|0.42|0.8998
91586817|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4618|TWO_SIDED|95.0|0.6|3.12||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 35||3.12|0.60|0.4618
91586818|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6154|TWO_SIDED|95.0|0.53|2.93||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 35||2.93|0.53|0.6154
91586819|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9442|TWO_SIDED|95.0|0.45|2.34||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 35||2.34|0.45|0.9442
91586820|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.36||||0.458|TWO_SIDED|95.0|0.6|3.08||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 36||3.08|0.60|0.4580
91586821|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6275|TWO_SIDED|95.0|0.52|2.95||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 36||2.95|0.52|0.6275
91586822|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3558|TWO_SIDED|95.0|0.65|3.36||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 36||3.36|0.65|0.3558
91586823|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.35||||0.4749|TWO_SIDED|95.0|0.6|3.04||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 37||3.04|0.60|0.4749
91647488|NCT03372369|183186967|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
91647489|NCT03372369|183186968|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
91647490|NCT03372369|183186968|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
91647491|NCT03372369|183186968|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
91647492|NCT01791127|183186971|SUPERIORITY|The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.|||||<|0.0001|||||||Exact, binomial|||||||<0.0001
91586824|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3672|TWO_SIDED|95.0|0.64|3.46||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 37||3.46|0.64|0.3672
91586825|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3462|TWO_SIDED|95.0|0.65|3.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 37||3.37|0.65|0.3462
91647493|NCT01791127|183186972|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 2 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
91647494|NCT01791127|183186973|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 3 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (successful sensing and pacing rate at 12 months) to 97.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
91709017|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.223||0.1202||95.0|-0.15|0.99|||ANOVA|||Difference from placebo (including Baseline); Day 8: 1 hour post-dose.||0.99|-0.15|0.1202
91586826|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.25||||0.5856|TWO_SIDED|95.0|0.56|2.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 38||2.82|0.56|0.5856
91586827|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.51||||0.3563|TWO_SIDED|95.0|0.64|3.58||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 38||3.58|0.64|0.3563
91647495|NCT01791127|183186974|SUPERIORITY|||||||||||||||||The primary endpoint 4 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 5 years) to 92.5%, with Type I error (alpha) or 0.025 and power of 80%.|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
91647496|NCT01017029|183187022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.482||||0.1043|TWO_SIDED|95.0|0.922|2.383|||Regression, Cox|||||2.383|0.922|0.1043
91647497|NCT01017029|183187024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.847||||0.0398|TWO_SIDED|95.0|1.029|3.315|||Regression, Cox|||||3.315|1.029|0.0398
91647498|NCT01017029|183187026|SUPERIORITY_OR_OTHER|||||||0.0234|||||||Fisher Exact|||CMV infections||||0.0234
91647499|NCT01017029|183187027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.403||||0.1966|TWO_SIDED|95.0|0.839|2.347|||Regression, Cox|||||2.347|0.839|0.1966
91709018|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.355||0.1204||95.0|-0.19|1.39|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||1.39|-0.19|0.1204
91586828|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6165|TWO_SIDED|95.0|0.54|2.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 38||2.82|0.54|0.6165
91586829|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4532|TWO_SIDED|95.0|0.6|3.1||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 39||3.10|0.60|0.4532
91586830|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4691|TWO_SIDED|95.0|0.58|3.27||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 39||3.27|0.58|0.4691
91586831|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3703|TWO_SIDED|95.0|0.64|3.32||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 39||3.32|0.64|0.3703
91586832|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9319|TWO_SIDED|95.0|0.43|2.15||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 40||2.15|0.43|0.9319
91779954|NCT02205736|183439987|SUPERIORITY|||||||0.0196||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0196
91779955|NCT02205736|183439987|SUPERIORITY||||||<|0.0001||||||This outcome measure for Q25 was tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5% in the analyses of 25 questions.|McNemar|||Patients gave True/False responses to Question 25 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
91779956|NCT01198977|183440002|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.013||||||Baseline and 3-month follow-up for arm 1 and arm 2.|ANOVA|||||||.013
91779957|NCT01198977|183440002|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.005||||||Comparing baseline to 6-month follow-up.|ANOVA|||||||0.005
91779958|NCT01198977|183440002|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.01||||||The interaction effect between the two conditions across time. Baseline, 3-month, 6-month.|ANOVA|||||||0.010
91779959|NCT01198977|183440003|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.009||||||Comparing depression scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||0.009
91779960|NCT01198977|183440003|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.032||||||Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months).|ANOVA|||||||.032
91647500|NCT00663039|183187061|SUPERIORITY|||||||0.758|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect Scores between Oxytocin and Placebo Arms||||0.758
91521226|NCT02954354|182917043|SUPERIORITY|||||||0.8512||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.8512
91521227|NCT02954354|182917043|SUPERIORITY|||||||0.8783||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.8783
91647501|NCT00663039|183187061|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill scores between Oxytocin and Placebo arms||||0.779
91647502|NCT00663039|183187062|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 1 scores between Oxytocin and Placebo Arms||||0.578
91647503|NCT00663039|183187062|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 2 scores between Oxytocin and Placebo Arms||||0.28
91647504|NCT00663039|183187062|SUPERIORITY|||||||0.707|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 3 scores between Oxytocin and Placebo Arms||||0.707
91647505|NCT00663039|183187063|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total amount of money offered during the trust game between the Oxytocin and Placebo arms||||0.391
91779961|NCT01198977|183440004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.049||||||Physical Activity Interaction effect between the Telephone Counseling and Education Counseling Group over time (baseline, 3 months, 6 months).|ANOVA|||||||0.049
91779962|NCT01198977|183440004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.014||||||Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||.014
91779963|NCT00664443|183440005|OTHER||Sensitivity|65.9|||||TWO_SIDED|95.0|63.5|68.2||||||||68.2|63.5|
91779964|NCT00664443|183440006|OTHER||Specificity|32.3|||||TWO_SIDED|95.0|29.0|35.9||||||||35.9|29.0|
91779965|NCT02153632|183440036|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|1.75||0.031|TWO_SIDED|95.0|-10.5|-0.5|||ANCOVA|||||-0.5|-10.5|0.031
91779966|NCT02153632|183440036|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|1.71||0.011|TWO_SIDED|95.0|-11.5|-1.5|||ANCOVA|||||-1.5|-11.5|0.011
91586833|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6374|TWO_SIDED|95.0|0.52|2.94||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 40||2.94|0.52|0.6374
91586834|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.49||||0.3457|TWO_SIDED|95.0|0.65|3.42||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 40||3.42|0.65|0.3457
91586835|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8906|TWO_SIDED|95.0|0.47|2.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 41||2.37|0.47|0.8906
91586836|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7882|TWO_SIDED|95.0|0.47|2.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 41||2.68|0.47|0.7882
91586837|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7898|TWO_SIDED|95.0|0.49|2.59||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 41||2.59|0.49|0.7898
91586838|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9521|TWO_SIDED|95.0|0.44|2.18||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 42||2.18|0.44|0.9521
91586839|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6001|TWO_SIDED|95.0|0.53|3.05||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 42||3.05|0.53|0.6001
91586840|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6054|TWO_SIDED|95.0|0.55|2.8||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 42||2.80|0.55|0.6054
91586841|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.81||||0.6042|TWO_SIDED|95.0|0.36|1.81||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 43||1.81|0.36|0.6042
91586842|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3465|TWO_SIDED|95.0|0.64|3.73||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 43||3.73|0.64|0.3465
91586843|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7427|TWO_SIDED|95.0|0.5|2.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 43||2.64|0.50|0.7427
91586844|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9218|TWO_SIDED|95.0|0.47|2.3||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 44||2.30|0.47|0.9218
91586845|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4909|TWO_SIDED|95.0|0.57|3.3||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 44||3.30|0.57|0.4909
91586846|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3616|TWO_SIDED|95.0|0.65|3.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 44||3.31|0.65|0.3616
91586847|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7578|TWO_SIDED|95.0|0.51|2.55||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 45||2.55|0.51|0.7578
91586848|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2369|TWO_SIDED|95.0|0.71|4.24||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 45||4.24|0.71|0.2369
91647506|NCT00663039|183187064|SUPERIORITY|||||||0.559|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.559
91647507|NCT00663039|183187064|SUPERIORITY|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.858
91647508|NCT00663039|183187064|SUPERIORITY|||||||0.514|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.514
91647509|NCT00663039|183187064|SUPERIORITY|||||||0.088|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.088
91647510|NCT00663039|183187065|SUPERIORITY|||||||0.296|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Oxytocin and Placebo arms.||||0.296
91647511|NCT00663039|183187065|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.136
91647512|NCT00663039|183187065|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Oxytocin and Placebo arms.||||0.47
91586849|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8774|TWO_SIDED|95.0|0.41|2.12||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 45||2.12|0.41|0.8774
91586850|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7578|TWO_SIDED|95.0|0.51|2.55||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 46||2.55|0.51|0.7578
91647513|NCT00663039|183187065|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.702
91647514|NCT00663039|183187066|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||Comparison of Brief Assessments of Cognition for Schizophrenia scores between the Oxytocin and Placebo arms.||||0.451
91647515|NCT00663039|183187067|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
91647516|NCT00663039|183187068|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||Comparison of Reading the Mind in the Eyes total scores between Oxytocin and Placebo arms||||0.946
91647517|NCT00663039|183187069|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Total scores between Oxytocin and Placebo arms||||0.016
91586851|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4691|TWO_SIDED|95.0|0.58|3.33||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 46||3.33|0.58|0.4691
91586852|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7272|TWO_SIDED|95.0|0.38|1.95||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 46||1.95|0.38|0.7272
91647518|NCT00663039|183187069|SUPERIORITY|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Hits between Oxytocin and Placebo arms||||0.185
91647519|NCT00663039|183187069|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition False Alarms between Oxytocin and Placebo arms||||0.404
91647520|NCT00323271|183187071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108||||0.911|TWO_SIDED|95.0|-2.106|1.888|||t-test, 2 sided|||||1.888|-2.106|.911
91647521|NCT00323271|183187072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.644||||0.32|TWO_SIDED|95.0|-1.058|2.345||Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|ANCOVA|||||2.345|-1.058|0.320
91647522|NCT04333199|183187073|SUPERIORITY||Odds Ratio (OR)|2.9903891|||<|0.001|TWO_SIDED|95.0|2.2805876|3.9211066||We used an a priori threshold of p \< .05.|Regression, Logistic|||||3.9211066|2.2805876|<0.001
91647523|NCT04333199|183187074|SUPERIORITY||Odds Ratio (OR)|1.1781659||||0.154|TWO_SIDED|95.0|0.9404654|1.4759445||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.4759445|0.9404654|0.154
91647524|NCT04333199|183187075|SUPERIORITY||Odds Ratio (OR)|0.9575636||||0.571|TWO_SIDED|95.0|0.8242111|1.1124918||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.1124918|0.8242111|0.571
91647525|NCT04333199|183187076|SUPERIORITY||Odds Ratio (OR)|1.8562672|||<|0.001|TWO_SIDED|95.0|1.5692523|2.1957769||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.1957769|1.5692523|<0.001
91647526|NCT04333199|183187078|SUPERIORITY||Odds Ratio (OR)|1.8542767|||<|0.001|TWO_SIDED|95.0|1.5220654|2.2589975||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.2589975|1.5220654|<0.001
91647527|NCT02981602|183187109|OTHER|||||||0.116||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.116
91647528|NCT02981602|183187109|OTHER||||||<|0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||<0.001
91647529|NCT02981602|183187109|OTHER|||||||0.573||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.573
91647530|NCT02981602|183187110|OTHER|||||||0.609||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.609
91647531|NCT02981602|183187110|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
91647532|NCT02981602|183187111|OTHER|Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group||||||0.245|||||||ANCOVA|||||||0.245
91647533|NCT02981602|183187111|OTHER|||||||0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.001
91779967|NCT04586205|183440059|OTHER|||||||0.024|||||||ANOVA|||The baseline measurement for this analysis is the Sternberg Sorting Task (SST) at Baseline. This task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS).||||0.024
91779968|NCT04586205|183440060|OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED||||||t-test, 2 sided||The difference in means between High-Load IAPS (.69) and Low-Load IAPS (.67) in the group that received active then sham TMS.|The baseline measurement for this analysis is the International Affective Picture System (IAPS) at baseline. This is an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. We compare mean High-Load IAPS and Low-Load IAPS scores in the group that received active then sham TMS.||||0.18
91779969|NCT04586205|183440061|OTHER|||||||0.19|||||||Chi-squared|||The outcome measure for this analysis was the International Affective Picture System (IAPS).||||0.19
91586853|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.05||||0.908|TWO_SIDED|95.0|0.47|2.35||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 47||2.35|0.47|0.9080
91586854|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6001|TWO_SIDED|95.0|0.53|3.05||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 47||3.05|0.53|0.6001
91586855|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5599|TWO_SIDED|95.0|0.35|1.76||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 47||1.76|0.35|0.5599
91586856|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9274|TWO_SIDED|95.0|0.43|2.17||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.17|0.43|0.9274
91586857|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9333|TWO_SIDED|95.0|0.44|2.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.47|0.44|0.9333
91586858|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7796|TWO_SIDED|95.0|0.5|2.5||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.50|0.50|0.7796
91586859|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.46||||0.8861|TWO_SIDED|95.0|0.46|2.44||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 49||2.44|0.46|0.8861
91586860|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7331|TWO_SIDED|95.0|0.36|2.03||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 49||2.03|0.36|0.7331
91779970|NCT04586205|183440062|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91779971|NCT04684836|183440064|SUPERIORITY|The analysis leveraged a difference-in-differences research design in an intent-to-treat framework, comparing outcomes for patients receiving care at high-telehealth practices with patients at comparable low-telehealth practices, before relative to after the onset of the pandemic (when telehealth use increased significantly).|Mean Difference (Net)|-0.0255||||0.0793|TWO_SIDED||||||Regression, Linear|All models included practice and year-quarter fixed effects, and clustered standard errors at the practice level.|This is the Unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|||||0.0793
91779972|NCT04684836|183440064|SUPERIORITY|Difference-in-differences model|Mean Difference (Net)|-0.0786||||0.5739|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||||||0.5739
91779973|NCT04684836|183440065|SUPERIORITY||Mean Difference (Net)|-0.0014||||0.3261|TWO_SIDED|||||This is an adjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences model||||0.3261
91779974|NCT04684836|183440065|SUPERIORITY||Mean Difference (Net)|0.0806|||<|0.01|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences model||||<0.01
91779975|NCT04684836|183440066|SUPERIORITY||Mean Difference (Net)|-0.0217||||0.1101|TWO_SIDED|||||This is an adjusted unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences||||0.1101
91779976|NCT04684836|183440066|SUPERIORITY||Mean Difference (Net)|0.5551||||0.4618|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.4618
91779977|NCT04684836|183440068|SUPERIORITY||Mean Difference (Net)|-0.0012||||0.8577|TWO_SIDED|||||This is an unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction|Regression, Linear|||Difference-in-differences||||0.8577
91586861|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5686|TWO_SIDED|95.0|0.35|1.78||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 49||1.78|0.35|0.5686
91586862|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.25||||0.601|TWO_SIDED|95.0|0.55|2.84||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 50||2.84|0.55|0.6010
91586863|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9732|TWO_SIDED|95.0|0.43|2.4||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 50||2.40|0.43|0.9732
91586864|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9378|TWO_SIDED|95.0|0.46|2.32||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 50||2.32|0.46|0.9378
91586865|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5799|TWO_SIDED|95.0|0.55|2.92||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 51||2.92|0.55|0.5799
91586866|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.01||||0.979|TWO_SIDED|95.0|0.42|2.44||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 51||2.44|0.42|0.9790
91586867|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7299|TWO_SIDED|95.0|0.51|2.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 51||2.64|0.51|0.7299
91586868|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7357|TWO_SIDED|95.0|0.51|2.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||2.64|0.51|0.7357
91586869|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.65||||0.3243|TWO_SIDED|95.0|0.28|1.51||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.51|0.28|0.3243
91586870|NCT03816891|183063659|SUPERIORITY||Odds Ratio (OR)|0.72||||0.4364|TWO_SIDED|95.0|0.32|1.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.63|0.32|0.4364
91586871|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.18||||0.0957|TWO_SIDED|95.0|0.6|44.6||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 1||44.60|0.60|0.0957
91586872|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.2||||0.5457|TWO_SIDED|95.0|0.17|28.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 1||28.14|0.17|0.5457
91586873|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.14||||0.3797|TWO_SIDED|95.0|0.24|41.51||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 1||41.51|0.24|0.3797
91586874|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|7.97||||0.0042|TWO_SIDED|95.0|1.64|38.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||38.75|1.64|0.0042
91586875|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.08||||0.0383|TWO_SIDED|95.0|0.99|26.09||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||26.09|0.99|0.0383
91586876|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0357|TWO_SIDED|95.0|1.02|28.92||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||28.92|1.02|0.0357
91647534|NCT02981602|183187111|OTHER|||||||0.762||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.762
91647535|NCT02981602|183187112|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
91586877|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|17.35|||<|0.0001|TWO_SIDED|95.0|3.86|77.91||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 3||77.91|3.86|<0.0001
91586878|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.04||||0.0408|TWO_SIDED|95.0|0.97|26.01||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 3||26.01|0.97|0.0408
91586879|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0357|TWO_SIDED|95.0|1.02|28.92||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 3||28.92|1.02|0.0357
91586880|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|4.51|62.54||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||62.54|4.51|<0.0001
91586881|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0116|TWO_SIDED|95.0|1.31|18.78||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||18.78|1.31|0.0116
91647536|NCT02981602|183187112|OTHER|||||||0.081||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.081
91647537|NCT02981602|183187112|OTHER|||||||0.616||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.616
91647538|NCT02981602|183187115|OTHER|||||||0.763||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.763
91779978|NCT04684836|183440068|SUPERIORITY||Mean Difference (Net)|0.2014||||0.5954|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.5954
91586882|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3738|TWO_SIDED|95.0|0.43|8.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||8.82|0.43|0.3738
91586883|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|44.08|||<|0.0001|TWO_SIDED|95.0|6.06|320.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 5||320.77|6.06|<0.0001
91586884|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|27.11||||0.0002|TWO_SIDED|95.0|2.73|268.93||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 5||268.93|2.73|0.0002
91586885|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|17.02||||0.0029|TWO_SIDED|95.0|1.74|166.84||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 5||166.84|1.74|0.0029
91586886|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|17.84|||<|0.0001|TWO_SIDED|95.0|4.7|67.78||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 6||67.78|4.70|<0.0001
91586887|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|9.86||||0.0002|TWO_SIDED|95.0|2.6|37.44||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 6||37.44|2.60|0.0002
91586888|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.87||||0.0055|TWO_SIDED|95.0|1.53|22.53||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 6||22.53|1.53|0.0055
91586889|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|14.14|||<|0.0001|TWO_SIDED|95.0|4.37|45.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 7||45.75|4.37|<0.0001
91586890|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|6.85||||0.0005|TWO_SIDED|95.0|2.11|22.25||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 7||22.25|2.11|0.0005
91586891|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|4.24||||0.016|TWO_SIDED|95.0|1.25|14.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 7||14.41|1.25|0.0160
91586892|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|14.14|||<|0.0001|TWO_SIDED|95.0|4.37|45.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||45.75|4.37|<0.0001
91586893|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0009|TWO_SIDED|95.0|1.93|20.33||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||20.33|1.93|0.0009
91586894|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|4.19||||0.0151|TWO_SIDED|95.0|1.25|14.04||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||14.04|1.25|0.0151
91586895|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|19.23|||<|0.0001|TWO_SIDED|95.0|5.35|69.06||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 9||69.06|5.35|<0.0001
91586896|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|11.51|||<|0.0001|TWO_SIDED|95.0|3.48|38.09||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 9||38.09|3.48|<0.0001
91586897|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|6.12||||0.0013|TWO_SIDED|95.0|1.86|20.2||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 9||20.20|1.86|0.0013
91586898|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|14.64|||<|0.0001|TWO_SIDED|95.0|4.89|43.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 10||43.82|4.89|<0.0001
91586899|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|9.59|||<|0.0001|TWO_SIDED|95.0|3.44|26.76||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 10||26.76|3.44|<0.0001
91779979|NCT02085161|183440131|SUPERIORITY_OR_OTHER||Treatment ratio|1.458|STANDARD_ERROR_OF_MEAN|0.147||0.0002|TWO_SIDED|95.0|1.196|1.777||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.777|1.196|0.0002
91779980|NCT02085161|183440131|SUPERIORITY_OR_OTHER||Treatment ratio|1.292|STANDARD_ERROR_OF_MEAN|0.129||0.0109|TWO_SIDED|95.0|1.061|1.573||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the second one in the alpha-protected hierarchical testing chain.||1.573|1.061|0.0109
91779981|NCT02085161|183440131|SUPERIORITY_OR_OTHER||Treatment ratio|1.041|STANDARD_ERROR_OF_MEAN|0.106||0.6895|TWO_SIDED|95.0|0.853|1.272||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.272|0.853|0.6895
91779982|NCT02085161|183440131|SUPERIORITY_OR_OTHER||Treatment ratio|1.128|STANDARD_ERROR_OF_MEAN|0.11||0.2188|TWO_SIDED|95.0|0.931|1.368||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.368|0.931|0.2188
91779983|NCT02085161|183440131|SUPERIORITY_OR_OTHER||Treatment ratio|1.241|STANDARD_ERROR_OF_MEAN|0.123||0.0303|TWO_SIDED|95.0|1.021|1.507||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.507|1.021|0.0303
91779984|NCT02085161|183440132|SUPERIORITY_OR_OTHER||LSMean Difference|-331.975|STANDARD_ERROR_OF_MEAN|296.375||0.2639|TWO_SIDED|95.0|-916.015|252.064||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||252.064|-916.015|0.2639
91779985|NCT02085161|183440132|SUPERIORITY_OR_OTHER||LSMean Difference|161.072|STANDARD_ERROR_OF_MEAN|293.506||0.5837|TWO_SIDED|95.0|-417.314|739.459||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||739.459|-417.314|0.5837
91779986|NCT02085161|183440132|SUPERIORITY_OR_OTHER||LSMean Difference|-524.926|STANDARD_ERROR_OF_MEAN|296.802||0.0783|TWO_SIDED|95.0|-1109.806|59.954||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||59.954|-1109.806|0.0783
91586900|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0049|TWO_SIDED|95.0|1.48|11.9||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 10||11.90|1.48|0.0049
91779987|NCT02085161|183440132|SUPERIORITY_OR_OTHER||LSMean Difference|-493.048|STANDARD_ERROR_OF_MEAN|289.566||0.09|TWO_SIDED|95.0|-1063.67|77.575||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||77.575|-1063.670|0.0900
91586901|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.3|||<|0.0001|TWO_SIDED|95.0|3.17|21.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 11||21.77|3.17|<0.0001
91586902|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.53|||<|0.0001|TWO_SIDED|95.0|2.2|13.92||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 11||13.92|2.20|<0.0001
91586903|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0939|TWO_SIDED|95.0|0.85|5.86||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 11||5.86|0.85|0.0939
91586904|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|7.68|||<|0.0001|TWO_SIDED|95.0|2.91|20.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||20.31|2.91|<0.0001
91647539|NCT02981602|183187115|OTHER|||||||0.804||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.804
91779988|NCT02085161|183440132|SUPERIORITY_OR_OTHER||LSMean Difference|685.998|STANDARD_ERROR_OF_MEAN|289.435||0.0186|TWO_SIDED|95.0|115.635|1256.362||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||1256.362|115.635|0.0186
91779989|NCT02085161|183440133|SUPERIORITY_OR_OTHER||LSMean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.5186|TWO_SIDED|95.0|-0.01|0.005||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.005|-0.010|0.5186
91586905|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|2.51|16.93||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||16.93|2.51|<0.0001
91586906|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1425|TWO_SIDED|95.0|0.77|5.28||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||5.28|0.77|0.1425
91586907|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|9.99|||<|0.0001|TWO_SIDED|95.0|3.61|27.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 13||27.64|3.61|<0.0001
91586908|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.31|||<|0.0001|TWO_SIDED|95.0|3.08|22.43||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 13||22.43|3.08|<0.0001
91586909|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0194|TWO_SIDED|95.0|1.17|8.6||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 13||8.60|1.17|0.0194
91586910|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|9.13|||<|0.0001|TWO_SIDED|95.0|3.5|23.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 14||23.77|3.50|<0.0001
91586911|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.02|||<|0.0001|TWO_SIDED|95.0|3.11|20.7||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 14||20.70|3.11|<0.0001
91586912|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0266|TWO_SIDED|95.0|1.12|7.87||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 14||7.87|1.12|0.0266
91586913|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|10.39|||<|0.0001|TWO_SIDED|95.0|3.85|28.0||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 15||28.00|3.85|<0.0001
91586914|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.15|||<|0.0001|TWO_SIDED|95.0|3.04|21.86||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 15||21.86|3.04|<0.0001
91586915|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0172|TWO_SIDED|95.0|1.22|9.29||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 15||9.29|1.22|0.0172
91586916|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.6|||<|0.0001|TWO_SIDED|95.0|3.34|22.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||22.14|3.34|<0.0001
91586917|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|2.91|19.79||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||19.79|2.91|<0.0001
91586918|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1252|TWO_SIDED|95.0|0.8|5.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||5.75|0.80|0.1252
91586919|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.01|||<|0.0001|TWO_SIDED|95.0|3.09|20.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 17||20.75|3.09|<0.0001
91586920|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|8.6|||<|0.0001|TWO_SIDED|95.0|3.3|22.4||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 17||22.40|3.30|<0.0001
91586921|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0074|TWO_SIDED|95.0|1.38|8.34||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 17||8.34|1.38|0.0074
91779990|NCT02085161|183440133|SUPERIORITY_OR_OTHER||LSMean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.6436|TWO_SIDED|95.0|-0.006|0.009||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.009|-0.006|0.6436
91779991|NCT02085161|183440133|SUPERIORITY_OR_OTHER||LSMean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.004||0.1081|TWO_SIDED|95.0|-0.014|0.001||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.001|-0.014|0.1081
91779992|NCT02085161|183440133|SUPERIORITY_OR_OTHER||LSMean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.004||0.2612|TWO_SIDED|95.0|-0.011|0.003||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.003|-0.011|0.2612
91779993|NCT02085161|183440133|SUPERIORITY_OR_OTHER||LSMean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.004||0.0361|TWO_SIDED|95.0|0.001|0.015||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.015|0.001|0.0361
91779994|NCT02085161|183440134|SUPERIORITY_OR_OTHER||LSMean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.056||0.1727|TWO_SIDED|95.0|-0.034|0.187||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.187|-0.034|0.1727
91779995|NCT02085161|183440134|SUPERIORITY_OR_OTHER||LSMean Difference|0.143|STANDARD_ERROR_OF_MEAN|0.055||0.0097|TWO_SIDED|95.0|0.035|0.252||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.252|0.035|0.0097
91779996|NCT02085161|183440134|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.056||0.7815|TWO_SIDED|95.0|-0.095|0.126||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.126|-0.095|0.7815
91779997|NCT02085161|183440134|SUPERIORITY_OR_OTHER||LSMean Difference|-0.067|STANDARD_ERROR_OF_MEAN|0.054||0.2183|TWO_SIDED|95.0|-0.174|0.04||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.040|-0.174|0.2183
91779998|NCT02085161|183440134|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.055||0.0203|TWO_SIDED|95.0|0.02|0.236||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.236|0.020|0.0203
91586922|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0015|TWO_SIDED|95.0|1.66|9.33||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||9.33|1.66|0.0015
91779999|NCT02085161|183440135|SUPERIORITY_OR_OTHER||Treatment ratio|1.333|STANDARD_ERROR_OF_MEAN|0.142||0.0077|TWO_SIDED|95.0|1.08|1.645||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|||1.645|1.080|0.0077
91780000|NCT02085161|183440135|SUPERIORITY_OR_OTHER||Treatment ratio|1.244|STANDARD_ERROR_OF_MEAN|0.131||0.039|TWO_SIDED|95.0|1.011|1.53||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|||1.530|1.011|0.0390
91780001|NCT02085161|183440135|SUPERIORITY_OR_OTHER||Treatment ratio|1.051|STANDARD_ERROR_OF_MEAN|0.113||0.6452|TWO_SIDED|95.0|0.85|1.299||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|||1.299|0.850|0.6452
91586923|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|5.03||||0.0003|TWO_SIDED|95.0|2.04|12.4||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||12.40|2.04|0.0003
91586924|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.82||||0.1667|TWO_SIDED|95.0|0.78|4.23||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||4.23|0.78|0.1667
91647540|NCT02981602|183187116|OTHER|||||||0.372||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.372
91521228|NCT02954354|182917043|SUPERIORITY|||||||0.8291||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.8291
91647541|NCT02981602|183187116|OTHER|||||||0.954||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.954
91647542|NCT00666718|183187118|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval (insulin lispro protamine suspension + insulin lispro minus insulin glargine+insulin lispro) at a significance level of 0.025 with 90% power."|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.11|0.31|||ANCOVA|||||0.31|-0.11|
91780002|NCT02085161|183440135|SUPERIORITY_OR_OTHER||Treatment ratio|1.071|STANDARD_ERROR_OF_MEAN|0.111||0.5048|TWO_SIDED|95.0|0.874|1.313||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.313|0.874|0.5048
91586925|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0087|TWO_SIDED|95.0|1.31|7.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 19||7.41|1.31|0.0087
91586926|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0079|TWO_SIDED|95.0|1.35|7.87||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 19||7.87|1.35|0.0079
91586927|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2631|TWO_SIDED|95.0|0.71|3.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 19||3.63|0.71|0.2631
91586928|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.59||||0.0263|TWO_SIDED|95.0|1.11|6.05||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||6.05|1.11|0.0263
91586929|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0643|TWO_SIDED|95.0|0.96|5.46||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||5.46|0.96|0.0643
91586930|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.44||||0.3954|TWO_SIDED|95.0|0.63|3.27||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||3.27|0.63|0.3954
91586931|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1083|TWO_SIDED|95.0|0.86|4.61||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 21||4.61|0.86|0.1083
91647543|NCT00666718|183187119|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||p-value is for Week 12 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.4580
91647544|NCT00666718|183187119|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Week 24 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.1070
91647545|NCT00666718|183187120|SUPERIORITY_OR_OTHER|||||||0.1333||95.0||||p-value is for HbA1c \<7.0%.|Fisher Exact|||||||0.1333
91586932|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0613|TWO_SIDED|95.0|0.96|5.69||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 21||5.69|0.96|0.0613
91586933|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.92||||0.1354|TWO_SIDED|95.0|0.82|4.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 21||4.47|0.82|0.1354
91586934|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.66||||0.2362|TWO_SIDED|95.0|0.72|3.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 22||3.82|0.72|0.2362
91586935|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0949|TWO_SIDED|95.0|0.88|5.17||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 22||5.17|0.88|0.0949
91586936|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5013|TWO_SIDED|95.0|0.58|3.04||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 22||3.04|0.58|0.5013
91647546|NCT00666718|183187120|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||p-value is for HbA1c \<=6.5%|Fisher Exact|||||||0.1213
91586937|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4386|TWO_SIDED|95.0|0.61|3.16||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 23||3.16|0.61|0.4386
91586938|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0504|TWO_SIDED|95.0|0.99|6.24||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 23||6.24|0.99|0.0504
91586939|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.45||||0.3781|TWO_SIDED|95.0|0.64|3.32||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 23||3.32|0.64|0.3781
91647547|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|||||TWO_SIDED|95.0|-0.43|1.17|||Mixed Models Analysis|Morning Pre-Meal measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.17|-0.43|
91647548|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|||||TWO_SIDED|95.0|-0.66|1.19|||Mixed Models Analysis|Morning Postprandial measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.19|-0.66|
91647549|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.15|0.57|||Mixed Models Analysis|Midday Pre-Meal measurement = Treatment +country + week +treatment\*country + treatment\*week (unstructured covariance was used).||||0.57|-1.15|
91780003|NCT02085161|183440135|SUPERIORITY_OR_OTHER||Treatment ratio|1.184|STANDARD_ERROR_OF_MEAN|0.123||0.1066|TWO_SIDED|95.0|0.964|1.453||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.453|0.964|0.1066
91780004|NCT02085161|183440136|SUPERIORITY_OR_OTHER||LSMean Difference|0.329|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.255|0.403||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.403|0.255|<0.0001
91780005|NCT02085161|183440136|SUPERIORITY_OR_OTHER||LSMean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.282|0.429||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.429|0.282|<0.0001
91780006|NCT02085161|183440136|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.099|0.249||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.249|0.099|<0.0001
91586940|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.83||||0.1535|TWO_SIDED|95.0|0.79|4.21||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 24||4.21|0.79|0.1535
91586941|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.09||||0.0925|TWO_SIDED|95.0|0.87|4.99||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 24||4.99|0.87|0.0925
91586942|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.75||||0.1948|TWO_SIDED|95.0|0.75|4.07||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 24||4.07|0.75|0.1948
91586943|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4304|TWO_SIDED|95.0|0.61|3.17||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 25||3.17|0.61|0.4304
91586944|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.17||||0.0873|TWO_SIDED|95.0|0.89|5.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 25||5.31|0.89|0.0873
91780007|NCT02085161|183440136|SUPERIORITY_OR_OTHER||LSMean Difference|-0.027|STANDARD_ERROR_OF_MEAN|0.037||0.4677|TWO_SIDED|95.0|-0.099|0.045||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.045|-0.099|0.4677
91780008|NCT02085161|183440136|SUPERIORITY_OR_OTHER||LSMean Difference|0.182|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.109|0.255||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.255|0.109|<0.0001
91780009|NCT02085161|183440137|SUPERIORITY_OR_OTHER||LSMean Difference|0.478|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|0.35|0.606||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.606|0.350|<0.0001
91586945|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3683|TWO_SIDED|95.0|0.64|3.38||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 25||3.38|0.64|0.3683
91586946|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3203|TWO_SIDED|95.0|0.66|3.48||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 26||3.48|0.66|0.3203
91586947|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1284|TWO_SIDED|95.0|0.82|4.98||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 26||4.98|0.82|0.1284
91586948|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.77||||0.179|TWO_SIDED|95.0|0.76|4.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 26||4.11|0.76|0.1790
91586949|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.28||||0.547|TWO_SIDED|95.0|0.56|2.91||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 27||2.91|0.56|0.5470
91780010|NCT02085161|183440137|SUPERIORITY_OR_OTHER||LSMean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|0.403|0.657||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.657|0.403|<0.0001
91780011|NCT02085161|183440137|SUPERIORITY_OR_OTHER||LSMean Difference|0.286|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.157|0.415||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.415|0.157|<0.0001
91780012|NCT02085161|183440137|SUPERIORITY_OR_OTHER||LSMean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.063||0.4107|TWO_SIDED|95.0|-0.176|0.072||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.072|-0.176|0.4107
91780013|NCT02085161|183440137|SUPERIORITY_OR_OTHER||LSMean Difference|0.244|STANDARD_ERROR_OF_MEAN|0.064||0.0002|TWO_SIDED|95.0|0.119|0.37||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.370|0.119|0.0002
91780014|NCT02085161|183440138|SUPERIORITY_OR_OTHER||LSMean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.179|0.457||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.457|0.179|<0.0001
91780015|NCT02085161|183440138|SUPERIORITY_OR_OTHER||LSMean Difference|0.302|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|0.165|0.439||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.439|0.165|<0.0001
91780016|NCT02085161|183440138|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.071||0.0145|TWO_SIDED|95.0|0.035|0.314||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.314|0.035|0.0145
91780017|NCT02085161|183440138|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.068||0.815|TWO_SIDED|95.0|-0.118|0.151||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.151|-0.118|0.8150
91586950|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.69||||0.2612|TWO_SIDED|95.0|0.68|4.16||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 27||4.16|0.68|0.2612
91586951|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5071|TWO_SIDED|95.0|0.57|3.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 27||3.11|0.57|0.5071
91586952|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4175|TWO_SIDED|95.0|0.61|3.19||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 28||3.19|0.61|0.4175
91586953|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.72||||0.284|TWO_SIDED|95.0|0.68|4.32||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 28||4.32|0.68|0.284
91586954|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9281|TWO_SIDED|95.0|0.46|2.33||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 28||2.33|0.46|0.9281
91780018|NCT02085161|183440138|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.069||0.0642|TWO_SIDED|95.0|-0.008|0.263||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.263|-0.008|0.0642
91780019|NCT03537404|183440144|OTHER||Geometric Mean Ratio|0.02|||||TWO_SIDED|90.0|-0.103|0.142|||||Cmax parameters were logarithmically transformed|||0.142|-0.103|
91780020|NCT03537404|183440144|OTHER||Geometric Mean Ratio|-0.022|||||TWO_SIDED|90.0|-0.22|0.175|||||Cmax parameters were logarithmically transformed|||0.175|-0.220|
91780021|NCT03537404|183440145|OTHER||Geometric Mean Ratio|0.041|||||TWO_SIDED|90.0|-0.075|0.157|||||AUCtau parameters were logarithmically transformed.|||0.157|-0.075|
91586955|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6987|TWO_SIDED|95.0|0.51|2.69||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 29||2.69|0.51|0.6987
91586956|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4794|TWO_SIDED|95.0|0.56|3.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 29||3.41|0.56|0.4794
91780022|NCT03537404|183440145|OTHER||Geometric Mean Ratio|-0.069|||||TWO_SIDED|90.0|-0.201|0.064|||||AUCtau parameters were logarithmically transformed|||0.064|-0.201|
91780023|NCT03537404|183440146|OTHER||Geometric Mean Ratio|0.271|||||TWO_SIDED|90.0|0.159|0.383|||||Cmax parameters were logarithmically transformed|||0.383|0.159|
91586957|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8164|TWO_SIDED|95.0|0.48|2.52||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 29||2.52|0.48|0.8164
91586958|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.28||||0.5484|TWO_SIDED|95.0|0.56|2.93||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 30||2.93|0.56|0.5484
91586959|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3596|TWO_SIDED|95.0|0.62|3.76||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 30||3.76|0.62|0.3596
91586960|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.21||||0.6414|TWO_SIDED|95.0|0.53|2.78||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 30||2.78|0.53|0.6414
91586961|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4233|TWO_SIDED|95.0|0.6|3.2||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 31||3.20|0.60|0.4233
91586962|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.51||||0.3632|TWO_SIDED|95.0|0.62|3.7||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 31||3.70|0.62|0.3632
91586963|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8018|TWO_SIDED|95.0|0.49|2.49||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 31||2.49|0.49|0.8018
91586964|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5465|TWO_SIDED|95.0|0.55|3.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||3.02|0.55|0.5465
91586965|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.68||||0.256|TWO_SIDED|95.0|0.68|4.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||4.14|0.68|0.2560
91586966|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.94||||0.881|TWO_SIDED|95.0|0.42|2.1||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.10|0.42|0.8810
91586967|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9701|TWO_SIDED|95.0|0.43|2.24||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 33||2.24|0.43|0.9701
91586968|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.56||||0.3331|TWO_SIDED|95.0|0.62|3.96||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 33||3.96|0.62|0.3331
91780024|NCT03537404|183440147|OTHER||Geometric Mean Ratio|0.074|||||TWO_SIDED|90.0|0.016|0.132|||||AUCtau parameters were logarithmically transformed|||0.132|0.016|
91780025|NCT03537404|183440148|OTHER||Geometric Mean Ratio|-0.148|||||TWO_SIDED|90.0|-0.45|0.153|||||Cmax parameters were logarithmically transformed|||0.153|-0.450|
91780026|NCT03537404|183440149|OTHER||Geometric Mean Ratio|-0.093|||||TWO_SIDED|90.0|-0.354|0.168|||||AUCtau parameters were logarithmically transformed|||0.168|-0.354|
91780027|NCT00068692|183440154|SUPERIORITY|||||||0.35||||||One-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration||||||0.35
91780028|NCT00068692|183440154|SUPERIORITY|||||||0.69||||||one-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration||||||0.69
91780029|NCT00123422|183440188|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Statistical tests were 2-sided and a p value of \< 0.05 was the criterion for statistical significance.|ANCOVA|The baseline value was the co-variate in this analysis.||||||0.015
91780030|NCT00123422|183440189|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|The baseline value was the co-variate in this analysis.||||||<0.05
91586969|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8386|TWO_SIDED|95.0|0.4|2.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 33||2.11|0.40|0.8386
91586970|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4091|TWO_SIDED|95.0|0.61|3.28||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 34||3.28|0.61|0.4091
91586971|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3746|TWO_SIDED|95.0|0.61|3.57||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 34||3.57|0.61|0.3746
91586972|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8018|TWO_SIDED|95.0|0.49|2.49||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 34||2.49|0.49|0.8018
91586973|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6717|TWO_SIDED|95.0|0.51|2.79||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 35||2.79|0.51|0.6717
91586974|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.99||||0.985|TWO_SIDED|95.0|0.41|2.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 35||2.41|0.41|0.9850
91586975|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9983|TWO_SIDED|95.0|0.43|2.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 35||2.31|0.43|0.9983
91586976|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.3||||0.5311|TWO_SIDED|95.0|0.56|3.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 36||3.02|0.56|0.5311
91586977|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6628|TWO_SIDED|95.0|0.5|2.99||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 36||2.99|0.50|0.6628
91586978|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.32||||0.5208|TWO_SIDED|95.0|0.56|3.09||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 36||3.09|0.56|0.5208
91586979|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8483|TWO_SIDED|95.0|0.46|2.55||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 37||2.55|0.46|0.8483
91586980|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6232|TWO_SIDED|95.0|0.5|3.2||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 37||3.20|0.50|0.6232
91586981|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8312|TWO_SIDED|95.0|0.46|2.61||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 37||2.61|0.46|0.8312
91586982|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5083|TWO_SIDED|95.0|0.55|3.3||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 38||3.30|0.55|0.5083
91586983|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8111|TWO_SIDED|95.0|0.44|2.86||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 38||2.86|0.44|0.8111
91647550|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|||||TWO_SIDED|95.0|-0.46|1.4|||Mixed Models Analysis|Midday Postprandial measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||1.40|-0.46|
91586984|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8089|TWO_SIDED|95.0|0.46|2.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 38||2.68|0.46|0.8089
91586985|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9723|TWO_SIDED|95.0|0.41|2.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 39||2.37|0.41|0.9723
91586986|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9883|TWO_SIDED|95.0|0.39|2.58||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 39||2.58|0.39|0.9883
91586987|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.83||||0.6781|TWO_SIDED|95.0|0.35|1.98||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 39||1.98|0.35|0.6781
91586988|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6924|TWO_SIDED|95.0|0.5|2.86||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 40||2.86|0.50|0.6924
91586989|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9883|TWO_SIDED|95.0|0.4|2.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 40||2.47|0.40|0.9883
91647551|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.93|0.83|||Mixed Models Analysis|Evening Pre-Meal measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||0.83|-0.93|
91586990|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8581|TWO_SIDED|95.0|0.39|2.18||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 40||2.18|0.39|0.8581
91586991|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9723|TWO_SIDED|95.0|0.41|2.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 41||2.37|0.41|0.9723
91586992|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9937|TWO_SIDED|95.0|0.38|2.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 41||2.63|0.38|0.9937
91586993|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.83||||0.6781|TWO_SIDED|95.0|0.35|1.98||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 41||1.98|0.35|0.6781
91586994|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9723|TWO_SIDED|95.0|0.41|2.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 42||2.37|0.41|0.9723
91586995|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9937|TWO_SIDED|95.0|0.38|2.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 42||2.63|0.38|0.9937
91586996|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.83||||0.6781|TWO_SIDED|95.0|0.35|1.98||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 42||1.98|0.35|0.6781
91586997|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8892|TWO_SIDED|95.0|0.44|2.57||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 43||2.57|0.44|0.8892
91586998|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6296|TWO_SIDED|95.0|0.5|3.21||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 43||3.21|0.50|0.6296
91586999|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7271|TWO_SIDED|95.0|0.36|2.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 43||2.02|0.36|0.7271
91587000|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9636|TWO_SIDED|95.0|0.4|2.42||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 44||2.42|0.40|0.9636
91587001|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6355|TWO_SIDED|95.0|0.32|2.0||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 44||2.00|0.32|0.6355
91587002|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.68||||0.3901|TWO_SIDED|95.0|0.28|1.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 44||1.64|0.28|0.3901
91587003|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5177|TWO_SIDED|95.0|0.54|3.36||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 45||3.36|0.54|0.5177
91587004|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.99||||0.991|TWO_SIDED|95.0|0.4|2.49||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 45||2.49|0.40|0.9910
91587005|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7064|TWO_SIDED|95.0|0.35|2.01||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 45||2.01|0.35|0.7064
91587006|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8373|TWO_SIDED|95.0|0.44|2.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 46||2.77|0.44|0.8373
91587007|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7614|TWO_SIDED|95.0|0.44|3.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 46||3.11|0.44|0.7614
91587008|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5301|TWO_SIDED|95.0|0.31|1.83||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 46||1.83|0.31|0.5301
91587009|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8248|TWO_SIDED|95.0|0.44|2.8||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 47||2.80|0.44|0.8248
91587010|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8374|TWO_SIDED|95.0|0.35|2.32||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 47||2.32|0.35|0.8374
91587011|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.69||||0.4088|TWO_SIDED|95.0|0.29|1.67||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 47||1.67|0.29|0.4088
91587012|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9745|TWO_SIDED|95.0|0.39|2.5||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.50|0.39|0.9745
91709019|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.289||0.4213||95.0|-0.44|0.93|||ANOVA|||Difference from placebo (including Baseline); Day 8: 3 hours post-dose.||0.93|-0.44|0.4213
91647552|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||||TWO_SIDED|95.0|-0.41|1.34|||Mixed Models Analysis|Evening Postprandial measurement = Treatment+country+week +treatment\*country + treatment\*week (unstructured covariance was used).||||1.34|-0.41|
91647553|NCT00666718|183187121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|||||TWO_SIDED|95.0|-0.67|0.96|||Mixed Models Analysis|0300 Hours measurement = Treatment+country+week+treatment\*country+treatment\*week (unstructured covariance was used).||||0.96|-0.67|
91587013|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.72||||0.4916|TWO_SIDED|95.0|0.28|1.84||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||1.84|0.28|0.4916
91587014|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.55||||0.1854|TWO_SIDED|95.0|0.23|1.35||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||1.35|0.23|0.1854
91587015|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8373|TWO_SIDED|95.0|0.44|2.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 49||2.77|0.44|0.8373
91587016|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5051|TWO_SIDED|95.0|0.29|1.83||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 49||1.83|0.29|0.5051
91647554|NCT00666718|183187122|SUPERIORITY_OR_OTHER|||||||0.5568||95.0||||p-value is for Fasting.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.5568
91647555|NCT00666718|183187122|SUPERIORITY_OR_OTHER|||||||0.7523||95.0||||p-value is for Post-breakfast.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.7523
91647556|NCT00666718|183187122|SUPERIORITY_OR_OTHER|||||||0.6448||95.0||||p-value is for Post-lunch.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.6448
91647557|NCT00666718|183187122|SUPERIORITY_OR_OTHER|||||||0.9122||95.0||||p-value is for Post-dinner.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment\*country (Mediterranean, rest of Europe)||||||0.9122
91780031|NCT02446899|183440217|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.3||||0.0013|TWO_SIDED|95.0|6.3|26.3||Nominal p-value.|Cochran-Mantel-Haenszel|||||26.3|6.3|0.0013
91780032|NCT02446899|183440218|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.0022|TWO_SIDED|95.0|6.5|28.2||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||28.2|6.5|0.0022
91780033|NCT02446899|183440219|SUPERIORITY||Mean Difference (Final Values)|21.2||||0.0135|TWO_SIDED|95.0|6.8|35.7||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||35.7|6.8|0.0135
91780034|NCT02446899|183440220|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.0392|TWO_SIDED|95.0|4.3|43.6||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||43.6|4.3|0.0392
91780035|NCT02446899|183440221|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.5469|TWO_SIDED|95.0|-10.6|20.0||Adjusted p-value|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||20.0|-10.6|0.5469
91587017|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.52||||0.1375|TWO_SIDED|95.0|0.21|1.24||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 49||1.24|0.21|0.1375
91647558|NCT00666718|183187123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-1.19|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-1.19|
91647559|NCT00666718|183187123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.11|-0.20|
91647560|NCT00666718|183187123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||||TWO_SIDED|95.0|-1.06|0.16|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.16|-1.06|
91780036|NCT02446899|183440222|SUPERIORITY||Rate Ratio|0.67||||0.0809|TWO_SIDED|95.0|0.48|0.94||Adjusted p-value.|Negative binomial regression|||Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.||0.94|0.48|0.0809
91780037|NCT01002339|183440227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||||||0.02
91521229|NCT02954354|182917043|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
91587018|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.18||||0.718|TWO_SIDED|95.0|0.49|2.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 50||2.82|0.49|0.7180
91587019|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7838|TWO_SIDED|95.0|0.37|2.13||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 50||2.13|0.37|0.7838
91587020|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5795|TWO_SIDED|95.0|0.34|1.83||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 50||1.83|0.34|0.5795
91587021|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5517|TWO_SIDED|95.0|0.54|3.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 51||3.14|0.54|0.5517
91587022|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.8||||0.606|TWO_SIDED|95.0|0.34|1.89||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 51||1.89|0.34|0.6060
91587023|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7491|TWO_SIDED|95.0|0.38|2.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 51||2.02|0.38|0.7491
91647561|NCT00666718|183187123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.06|-0.86|
91587024|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8593|TWO_SIDED|95.0|0.45|2.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||2.63|0.45|0.8593
91587025|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.55||||0.1868|TWO_SIDED|95.0|0.23|1.32||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.32|0.23|0.1868
91587026|NCT03816891|183063660|SUPERIORITY||Odds Ratio (OR)|0.61||||0.2436|TWO_SIDED|95.0|0.26|1.41||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.41|0.26|0.2436
91587027|NCT03816891|183063661|SUPERIORITY|||||||0.0841||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||||0.0841
91587028|NCT03816891|183063661|SUPERIORITY|||||||0.3442||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||||0.3442
91780038|NCT01002339|183440228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Chi-squared|||||||0.06
91587029|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|3.22||||0.3083|TWO_SIDED|95.0|0.31|33.01||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||33.01|0.31|0.3083
91780039|NCT01002339|183440229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
91780040|NCT01002339|183440230|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Chi-squared|||||||0.07
91780041|NCT01002339|183440231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||ANOVA|||||||0.2
91587030|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|2.2||||0.4905|TWO_SIDED|95.0|0.21|22.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||22.64|0.21|0.4905
91587031|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.81||||0.6379|TWO_SIDED|95.0|0.15|21.08||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||21.08|0.15|0.6379
91587032|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|7.37||||0.0073|TWO_SIDED|95.0|1.48|36.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||36.68|1.48|0.0073
91587033|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|2.68||||0.2453|TWO_SIDED|95.0|0.49|14.66||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||14.66|0.49|0.2453
91587034|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.43||||0.4853|TWO_SIDED|95.0|0.04|4.9||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||4.90|0.04|0.4853
91647562|NCT00666718|183187123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days=Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-0.14|
91780042|NCT01002339|183440232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||ANOVA|||||||0.4
91780043|NCT01002339|183440233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||||||0.8
91780044|NCT01002339|183440234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||ANOVA|||||||0.56
91780045|NCT01002339|183440235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Kruskal-Wallis|||||||0.8
91780046|NCT01002339|183440236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||||||0.66
91780047|NCT01002339|183440237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|||||||ANOVA|||||||0.37
91780048|NCT01002339|183440238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||||||0.45
91780049|NCT01002339|183440239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.50
91780050|NCT01002339|183440240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||Chi-squared|||||||0.17
91780051|NCT01002339|183440241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.5
91780052|NCT01002339|183440242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
91780053|NCT02215252|183440243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.355|||TWO_SIDED|90.0|-1.0|0.17||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||0.17|-1.00|
91780054|NCT02215252|183440243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.23|||TWO_SIDED|90.0|-0.91|-0.2||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||-0.20|-0.91|
91647563|NCT00666718|183187124|SUPERIORITY_OR_OTHER|||||||0.1701||95.0||||p-value is for \>=1 hypoglycemic episode.|Fisher Exact|||||||0.1701
91780055|NCT02215252|183440244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||||TWO_SIDED|90.0|0.78|4.69||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.69|0.78|
91780056|NCT02215252|183440244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|90.0|1.06|6.56||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||6.56|1.06|
91780057|NCT02215252|183440245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|90.0|0.33|4.74||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.74|0.33|
91780058|NCT02215252|183440245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75|||||TWO_SIDED|90.0|1.43|15.81||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||15.81|1.43|
91780059|NCT02215252|183440246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-1.75|-0.32||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.32|-1.75|
91780060|NCT02215252|183440246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-1.43|0.04||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.04|-1.43|
91647564|NCT00666718|183187124|SUPERIORITY_OR_OTHER|||||||0.1727||95.0||||p-value is for \>=1 nocturnal hypoglycemic episode.|Fisher Exact|||||||0.1727
91780061|NCT02215252|183440247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-0.86|0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.43|-0.86|
91780062|NCT02215252|183440247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|90.0|-1.33|0.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.00|-1.33|
91780063|NCT02215252|183440248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.87|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.87|
91780064|NCT02215252|183440248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-1.36|0.2||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.20|-1.36|
91780065|NCT02215252|183440249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.49|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.49|
91780066|NCT02215252|183440249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.13||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.13|-1.05|
91780067|NCT02215252|183440250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.09|0.39||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.39|-1.09|
91780068|NCT02215252|183440250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.0|0.51||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.51|-1.00|
91780069|NCT02215252|183440251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-5.12|4.57||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||4.57|-5.12|
91780070|NCT02215252|183440251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-10.57|-0.66||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.66|-10.57|
91780071|NCT02215252|183440252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|0.34|1.45||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.45|0.34|
91780072|NCT02215252|183440252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|90.0|0.24|1.07||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.07|0.24|
91780073|NCT02215252|183440253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.16|-0.02||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.02|-1.16|
91780074|NCT02215252|183440253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.57|-0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.43|-1.57|
91780075|NCT02215252|183440254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.0|STANDARD_ERROR_OF_MEAN|816.0|||TWO_SIDED|90.0|-1161.0|1544.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1544|-1161|
91780076|NCT02215252|183440254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|611.0|STANDARD_ERROR_OF_MEAN|812.0|||TWO_SIDED|90.0|-735.0|1956.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1956|-735|
91780077|NCT02215252|183440258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|90.0|2.98|13.01||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||13.01|2.98|
91780078|NCT02215252|183440258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|3.14|||TWO_SIDED|90.0|-4.46|5.95||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||5.95|-4.46|
91587035|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0205|TWO_SIDED|95.0|1.15|10.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||10.68|1.15|0.0205
91587036|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0548|TWO_SIDED|95.0|0.95|9.78||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||9.78|0.95|0.0548
91587037|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.76||||0.6853|TWO_SIDED|95.0|0.19|2.96||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||2.96|0.19|0.6853
91587038|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|5.65||||0.0017|TWO_SIDED|95.0|1.83|17.47||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||17.47|1.83|0.0017
91587039|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|3.61||||0.0196|TWO_SIDED|95.0|1.19|10.99||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||10.99|1.19|0.0196
91587040|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6213|TWO_SIDED|95.0|0.4|4.69||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||4.69|0.40|0.6213
91587041|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|7.44||||0.0003|TWO_SIDED|95.0|2.33|23.73||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||23.73|2.33|0.0003
91587042|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|4.84||||0.006|TWO_SIDED|95.0|1.5|15.58||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||15.58|1.50|0.0060
91587043|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3432|TWO_SIDED|95.0|0.54|6.07||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||6.07|0.54|0.3432
91647565|NCT00666718|183187124|SUPERIORITY_OR_OTHER|||||||0.2094||95.0||||p-value is for \>=1 non-nocturnal hypoglycemic episode.|Fisher Exact|||||||0.2094
91521230|NCT02954354|182917043|SUPERIORITY|||||||0.9312||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.9312
91587044|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0012|TWO_SIDED|95.0|1.84|13.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||13.37|1.84|0.0012
91587045|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0121|TWO_SIDED|95.0|1.27|8.11||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||8.11|1.27|0.0121
91587046|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8315|TWO_SIDED|95.0|0.41|3.08||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||3.08|0.41|0.8315
91647566|NCT00666718|183187124|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||p-value is for \>=1 severe hypoglycemic episode.|Fisher Exact|||||||0.6230
91647567|NCT00666718|183187126|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.86|0.55|||ANCOVA|weight change from baseline = Treatment + country + baseline Hb1Ac + baseline weight + treatment\*HbA1c baseline value||||0.55|-0.86|
91780079|NCT02215252|183440259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.55|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|2.94|20.17||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||20.17|2.94|
91780080|NCT02215252|183440259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-11.38|6.54||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||6.54|-11.38|
91780081|NCT01106690|183440297|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.811|-0.437|||ANCOVA|||||-0.437|-0.811|<0.001
91587047|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4161|TWO_SIDED|95.0|0.61|3.35||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||3.35|0.61|0.4161
91587048|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6277|TWO_SIDED|95.0|0.54|2.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.82|0.54|0.6277
91587049|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.69||||0.4128|TWO_SIDED|95.0|0.29|1.64||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||1.64|0.29|0.4128
91587050|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9726|TWO_SIDED|95.0|0.42|2.3||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.30|0.42|0.9726
91647568|NCT00666718|183187127|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||||TWO_SIDED|95.0|-8.33|12.68|||Mixed Models Analysis|Total daily insulin dose=Treatment+country+week+treatment\*country+ treatment\*week (unstructured covariance was used).||||12.68|-8.33|
91647569|NCT01032330|183187129|SUPERIORITY||Risk Difference (RD)|0.054||||0.004|ONE_SIDED|95.0|0.02||||One-sided Barnard's Test||||||0.020|0.004
91587051|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|1.05||||0.907|TWO_SIDED|95.0|0.46|2.39||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.39|0.46|0.9070
91587052|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.49||||0.0944|TWO_SIDED|95.0|0.21|1.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||1.14|0.21|0.0944
91587053|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.83||||0.6513|TWO_SIDED|95.0|0.37|1.88||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.88|0.37|0.6513
91587054|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5924|TWO_SIDED|95.0|0.35|1.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.82|0.35|0.5924
91587055|NCT03816891|183063661|SUPERIORITY||Odds Ratio (OR)|0.6||||0.2313|TWO_SIDED|95.0|0.27|1.38||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.38|0.27|0.2313
91587056|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|3.19||||0.3137|TWO_SIDED|95.0|0.31|33.17||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||33.17|0.31|0.3137
91587057|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|2.0||||0.5982|TWO_SIDED|95.0|0.16|25.75||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||25.75|0.16|0.5982
91647570|NCT01032330|183187130|OTHER||cumulative probability|0.15|||||TWO_SIDED|95.0|0.1|0.22|||||Kaplan-Meier estimate of cumulative probability of deterioration by 3 years|||.22|.10|
91587058|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|2.8||||0.3244|TWO_SIDED|95.0|0.31|25.38||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||25.38|0.31|0.3244
91587059|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|7.58||||0.0266|TWO_SIDED|95.0|0.96|59.86||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||59.86|0.96|0.0266
91587060|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0892|TWO_SIDED|95.0|0.63|42.8||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||42.80|0.63|0.0892
91647571|NCT01032330|183187131|SUPERIORITY||Risk Difference (RD)|0.024||||0.27|TWO_SIDED|95.0|-0.038|0.094|||One-sided Barnard's Test|||||0.094|-0.038|0.27
91647572|NCT01032330|183187133|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
91587061|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|4.06||||0.1864|TWO_SIDED|95.0|0.44|37.67||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||37.67|0.44|0.1864
91587062|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|9.27||||0.002|TWO_SIDED|95.0|1.89|45.55||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||45.55|1.89|0.0020
91587063|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0141|TWO_SIDED|95.0|1.28|32.22||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||32.22|1.28|0.0141
91587064|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|1.93||||0.4485|TWO_SIDED|95.0|0.34|10.89||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||10.89|0.34|0.4485
91587065|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0235|TWO_SIDED|95.0|1.14|9.55||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||9.55|1.14|0.0235
91587066|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0252|TWO_SIDED|95.0|1.13|9.59||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||9.59|1.13|0.0252
91587067|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.93||||0.9062|TWO_SIDED|95.0|0.27|3.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||3.14|0.27|0.9062
91587068|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|4.55||||0.0041|TWO_SIDED|95.0|1.57|13.19||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||13.19|1.57|0.0041
91647573|NCT01032330|183187134|OTHER|||||||0.38|||||||ANCOVA|||Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.||||0.38
91647574|NCT01032330|183187135|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
91521231|NCT02954354|182917044|SUPERIORITY|||||||0.2953||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.2953
91587069|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|4.72||||0.0025|TWO_SIDED|95.0|1.66|13.39||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||13.39|1.66|0.0025
91587070|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1632|TWO_SIDED|95.0|0.73|6.76||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||6.76|0.73|0.1632
91780082|NCT01106690|183440297|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.951|-0.575|||ANCOVA|||||-0.575|-0.951|<0.001
91780083|NCT01106690|183440298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.007||95.0|1.26|4.57|||Regression, Logistic|||||4.57|1.26|0.007
91587071|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|4.09||||0.003|TWO_SIDED|95.0|1.57|10.65||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||10.65|1.57|0.0030
91587072|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0014|TWO_SIDED|95.0|1.8|13.91||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||13.91|1.80|0.0014
91587073|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|1.73||||0.3017|TWO_SIDED|95.0|0.62|4.82||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||4.82|0.62|0.3017
91587074|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0018|TWO_SIDED|95.0|1.67|10.48||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||10.48|1.67|0.0018
91587075|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0017|TWO_SIDED|95.0|1.69|10.99||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||10.99|1.69|0.0017
91587076|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5365|TWO_SIDED|95.0|0.52|3.55||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||3.55|0.52|0.5365
91587077|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8774|TWO_SIDED|95.0|0.46|2.46||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.46|0.46|0.8774
91780084|NCT01106690|183440298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38|||<|0.001|TWO_SIDED|95.0|2.73|10.6|||Regression, Logistic|||||10.60|2.73|<0.001
91780085|NCT01106690|183440299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|3.857|<|0.001|TWO_SIDED|95.0|-36.96|-21.78|||ANCOVA|||||-21.78|-36.96|<0.001
91780086|NCT01106690|183440299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|3.861|<|0.001|TWO_SIDED|95.0|-43.3|-28.11|||ANCOVA|||||-28.11|-43.30|<0.001
91780087|NCT01106690|183440300|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|14.28|STANDARD_ERROR_OF_MEAN|2.521|<|0.001|TWO_SIDED|95.0|9.315|19.236|||ANCOVA|||||19.236|9.315|<0.001
91780088|NCT01106690|183440300|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|17.23|STANDARD_ERROR_OF_MEAN|2.509|<|0.001|TWO_SIDED|95.0|12.293|22.166|||ANCOVA|||||22.166|12.293|<0.001
91780089|NCT01106690|183440301|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.6|-1.8|||ANCOVA|||||-1.8|-3.6|<0.001
91780090|NCT01106690|183440301|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-4.6|-2.8|||ANCOVA|||||-2.8|-4.6|<0.001
91587078|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7261|TWO_SIDED|95.0|0.5|2.7||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.70|0.50|0.7261
91587079|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4195|TWO_SIDED|95.0|0.31|1.63||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||1.63|0.31|0.4195
91587080|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9759|TWO_SIDED|95.0|0.42|2.31||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.31|0.42|0.9759
91587081|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6857|TWO_SIDED|95.0|0.51|2.81||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.81|0.51|0.6857
91780091|NCT01106690|183440302|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|1.43||0.005|TWO_SIDED|95.0|-6.879|-1.251|||ANCOVA|||||-1.251|-6.879|0.005
91780092|NCT01106690|183440302|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.46|STANDARD_ERROR_OF_MEAN|1.433||0.016|TWO_SIDED|95.0|-6.281|-0.643|||ANCOVA|||||-0.643|-6.281|0.016
91780093|NCT01106690|183440303|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|5.7||0.034|TWO_SIDED|95.0|-12.1|-0.9|||ANCOVA|||||-0.9|-12.1|0.034
91780094|NCT01106690|183440303|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.003|TWO_SIDED|95.0|-28.1|-5.8|||ANCOVA|||||-5.8|-28.1|0.003
91780095|NCT01106690|183440304|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|1.9||0.01|TWO_SIDED|95.0|1.2|8.5|||ANCOVA|||||8.5|1.2|0.010
91780096|NCT01106690|183440304|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.8|10.2|||ANCOVA|||||10.2|2.8|<0.001
91780097|NCT02683577|183440316|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|1.695|||||TWO_SIDED|90.0|0.904|3.176|||||A repeated-measures analysis of variance (ANOVA) was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.176|0.904|
91780098|NCT02683577|183440316|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.462|||||TWO_SIDED|90.0|1.579|3.837|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.837|1.579|
91780099|NCT02683577|183440317|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the mild HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
91780100|NCT02683577|183440317|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the moderate HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
91780101|NCT02683577|183440318|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.294|||||TWO_SIDED|90.0|1.144|4.598|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for AUC(0-tlast) values for telotristat ethyl.||4.598|1.144|
91780102|NCT02683577|183440318|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.168|||||TWO_SIDED|90.0|1.715|5.852|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for telotristat ethyl.||5.852|1.715|
91780103|NCT02683577|183440320|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.72|||||TWO_SIDED|90.0|1.11|2.65|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for LP-778902.||2.65|1.11|
91780104|NCT02683577|183440320|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.0|||||TWO_SIDED|90.0|1.51|2.66|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on Cmax values for LP-778902.||2.66|1.51|
91780105|NCT02683577|183440321|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.316|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.3160
91780106|NCT02683577|183440321|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.4671|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.4671
91587082|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.44||||0.0633|TWO_SIDED|95.0|0.19|1.04||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||1.04|0.19|0.0633
91587083|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.82||||0.6466|TWO_SIDED|95.0|0.36|1.88||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.88|0.36|0.6466
91587084|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9298|TWO_SIDED|95.0|0.41|2.23||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||2.23|0.41|0.9298
91647575|NCT01032330|183187136|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
91647576|NCT01032330|183187136|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
91780107|NCT02683577|183440322|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.39|||||TWO_SIDED|90.0|1.45|3.94|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||3.94|1.45|
91587085|NCT03816891|183063662|SUPERIORITY||Odds Ratio (OR)|0.65||||0.3143|TWO_SIDED|95.0|0.29|1.49||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.49|0.29|0.3143
91587086|NCT03816891|183063663|SUPERIORITY|||||||0.1656||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||||0.1656
91647577|NCT01032330|183187137|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
91587087|NCT03816891|183063663|SUPERIORITY|||||||0.3026||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||||0.3026
91780108|NCT02683577|183440322|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.52|||||TWO_SIDED|90.0|2.45|5.03|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||5.03|2.45|
91780109|NCT02683577|183440323|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.26|||||TWO_SIDED|90.0|1.33|3.82|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on ln transformed AUC(0-inf) values for LP-778902.||3.82|1.33|
91780110|NCT02683577|183440323|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.32|||||TWO_SIDED|90.0|2.3|4.8|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-inf) values for LP-778902.||4.80|2.30|
91780111|NCT03219528|183440326|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Baseline||||0.78
91780112|NCT03219528|183440326|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||Week 5||||0.88
91780113|NCT03219528|183440335|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Baseline||||0.77
91780114|NCT03219528|183440335|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Week 5||||0.58
91780115|NCT00790842|183440343|OTHER|Recommended Phase 2 dose for Group A|Dose in milligrams per day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day|Recommended Phase 2 dose for Group A||||
91780116|NCT00790842|183440343|OTHER|Recommended phase 2 dose for patients in Group B|Dose in milligrams/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis|Recommended phase 2 dose for patients in Group B||||
91780117|NCT00790842|183440343|OTHER|Recommended phase 2 dose for Group C|Lenalidomide dose in mg/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis|Recommended phase 2 dose for Group C||||
91780118|NCT05571605|183440362|OTHER|||||||0.05|||||||ANOVA|||||||0.05
91780119|NCT01285323|183440451|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4063|||<|0.0001|TWO_SIDED|95.0|0.2819|0.5855||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5855|0.2819|<0.0001
91780120|NCT01285323|183440452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.0397||0.0109|TWO_SIDED|95.0|0.023|0.179||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.179|0.023|0.0109
91780121|NCT01285323|183440453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.0317||0.0037|TWO_SIDED|95.0|0.03|0.155||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active-placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.155|0.030|0.0037
91780122|NCT01285323|183440454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.937||0.0259|TWO_SIDED|95.0|0.025|0.393||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.393|0.025|0.0259
91780123|NCT01285323|183440455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.196|STANDARD_ERROR_OF_MEAN|0.0664||0.0032|TWO_SIDED|95.0|-0.327|-0.066||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||-0.066|-0.327|0.0032
91780124|NCT01285323|183440456|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.353|0.67|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.670|0.353|<0.0001
91587088|NCT03816891|183063663|SUPERIORITY|||||||0.3442||||||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||||0.3442
91587089|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|4.6||||0.1641|TWO_SIDED|95.0|0.47|45.07||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||45.07|0.47|0.1641
91587090|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|2.24||||0.5103|TWO_SIDED|95.0|0.2|25.61||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||25.61|0.20|0.5103
91587091|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|2.03||||0.5457|TWO_SIDED|95.0|0.19|22.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||22.02|0.19|0.5457
91587092|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0722|TWO_SIDED|95.0|0.8|22.44||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||22.44|0.80|0.0722
91587093|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|2.85||||0.2215|TWO_SIDED|95.0|0.51|16.01||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||16.01|0.51|0.2215
91587094|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.42||||0.4872|TWO_SIDED|95.0|0.03|5.06||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||5.06|0.03|0.4872
91587095|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|3.03||||0.055|TWO_SIDED|95.0|0.95|9.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||9.68|0.95|0.0550
91587096|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|1.79||||0.3519|TWO_SIDED|95.0|0.52|6.1||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||6.10|0.52|0.3519
91587097|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8266|TWO_SIDED|95.0|0.22|3.34||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||3.34|0.22|0.8266
91587098|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|7.99||||0.0009|TWO_SIDED|95.0|2.11|30.3||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||30.30|2.11|0.0009
91587099|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|4.93||||0.0116|TWO_SIDED|95.0|1.32|18.39||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||18.39|1.32|0.0116
91587100|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|2.5||||0.2127|TWO_SIDED|95.0|0.59|10.6||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||10.60|0.59|0.2127
91587101|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|7.0||||0.0006|TWO_SIDED|95.0|2.17|22.61||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||22.61|2.17|0.0006
91647578|NCT01032330|183187137|OTHER|||||||0.33|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.33
91587102|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|4.61||||0.0061|TWO_SIDED|95.0|1.47|14.43||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||14.43|1.47|0.0061
91587103|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|2.08||||0.2317|TWO_SIDED|95.0|0.62|6.9||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||6.90|0.62|0.2317
91587104|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0093|TWO_SIDED|95.0|1.36|9.81||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||9.81|1.36|0.0093
91587105|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0183|TWO_SIDED|95.0|1.21|8.8||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||8.80|1.21|0.0183
91587106|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7648|TWO_SIDED|95.0|0.4|3.45||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||3.45|0.40|0.7648
91587107|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|1.54||||0.337|TWO_SIDED|95.0|0.65|3.68||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||3.68|0.65|0.3370
91587108|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5054|TWO_SIDED|95.0|0.57|3.16||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||3.16|0.57|0.5054
91647579|NCT01032330|183187138|OTHER|||||||0.013|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.013
91587109|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.49||||0.1341|TWO_SIDED|95.0|0.19|1.24||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||1.24|0.19|0.1341
91587110|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9628|TWO_SIDED|95.0|0.43|2.25||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.25|0.43|0.9628
91587111|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9185|TWO_SIDED|95.0|0.46|2.39||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.39|0.46|0.9185
91587112|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.42||||0.0496|TWO_SIDED|95.0|0.18|1.0||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||1.00|0.18|0.0496
91587113|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7785|TWO_SIDED|95.0|0.38|2.04||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||2.04|0.38|0.7785
91587114|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8857|TWO_SIDED|95.0|0.42|2.13||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||2.13|0.42|0.8857
91587115|NCT03816891|183063663|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4174|TWO_SIDED|95.0|0.31|1.62||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.62|0.31|0.4174
91587116|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|2.02||||0.5673|TWO_SIDED|95.0|0.18|22.87||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||22.87|0.18|0.5673
91587117|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|3.17||||0.3139|TWO_SIDED|95.0|0.31|32.21||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||32.21|0.31|0.3139
91587118|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.88||||0.6197|TWO_SIDED|95.0|0.16|22.83||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 2||22.83|0.16|0.6197
91587119|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|6.95||||0.048|TWO_SIDED|95.0|0.8|60.25||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||60.25|0.80|0.0480
91587120|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0945|TWO_SIDED|95.0|0.62|48.12||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||48.12|0.62|0.0945
91647580|NCT01032330|183187138|OTHER|||||||0.26|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.26
91587121|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|4.29||||0.1745|TWO_SIDED|95.0|0.45|40.6||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 4||40.60|0.45|0.1745
91587122|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|5.49||||0.0233|TWO_SIDED|95.0|1.1|27.25||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||27.25|1.10|0.0233
91587123|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|3.21||||0.1422|TWO_SIDED|95.0|0.63|16.53||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||16.53|0.63|0.1422
91587124|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.92||||0.481|TWO_SIDED|95.0|0.31|11.77||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 8||11.77|0.31|0.4810
91587125|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0628|TWO_SIDED|95.0|0.93|8.6||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||8.60|0.93|0.0628
91587126|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1149|TWO_SIDED|95.0|0.8|6.87||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||6.87|0.80|0.1149
91587127|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9726|TWO_SIDED|95.0|0.3|3.48||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 12||3.48|0.30|0.9726
91587128|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|3.76||||0.0134|TWO_SIDED|95.0|1.28|11.0||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||11.00|1.28|0.0134
91587129|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0148|TWO_SIDED|95.0|1.21|9.06||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||9.06|1.21|0.0148
91587130|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1611|TWO_SIDED|95.0|0.73|6.71||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 16||6.71|0.73|0.1611
91647581|NCT01032330|183187139|OTHER|||||||0.42|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.42
91587131|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|3.72||||0.0061|TWO_SIDED|95.0|1.44|9.6||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||9.60|1.44|0.0061
91587132|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0228|TWO_SIDED|95.0|1.13|7.18||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||7.18|1.13|0.0228
91587133|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3331|TWO_SIDED|95.0|0.61|4.37||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 18||4.37|0.61|0.3331
91587134|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1718|TWO_SIDED|95.0|0.78|4.38||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||4.38|0.78|0.1718
91587135|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1219|TWO_SIDED|95.0|0.83|4.66||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||4.66|0.83|0.1219
91587136|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9755|TWO_SIDED|95.0|0.4|2.45||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 20||2.45|0.40|0.9755
91587137|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7579|TWO_SIDED|95.0|0.38|2.02||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.02|0.38|0.7579
91587138|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9213|TWO_SIDED|95.0|0.42|2.19||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||2.19|0.42|0.9213
91587139|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.49||||0.1001|TWO_SIDED|95.0|0.21|1.14||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 32||1.14|0.21|0.1001
91587140|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7945|TWO_SIDED|95.0|0.39|2.05||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.05|0.39|0.7945
91587141|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7214|TWO_SIDED|95.0|0.51|2.69||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||2.69|0.51|0.7214
91587142|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0727|TWO_SIDED|95.0|0.2|1.07||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 48||1.07|0.20|0.0727
91780125|NCT01285323|183440457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.012||0.0037|TWO_SIDED|95.0|0.011|0.059||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.059|0.011|0.0037
91587143|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.74||||0.4871|TWO_SIDED|95.0|0.32|1.72||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.72|0.32|0.4871
91587144|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6037|TWO_SIDED|95.0|0.35|1.85||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.85|0.35|0.6037
91587145|NCT03816891|183063664|SUPERIORITY||Odds Ratio (OR)|0.53||||0.1323|TWO_SIDED|95.0|0.23|1.22||Calculated from CMH tests adjusted by the randomization stratification variables: sex and years since the first nodule observed (≥10 vs. \<10 years).|Cochran-Mantel-Haenszel|||Week 52||1.22|0.23|0.1323
91587146|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-1.6|-3.8|<0.0001
91587147|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.3|-1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-1.2|-3.3|<0.0001
91587148|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.55||0.0125|TWO_SIDED|95.0|-2.5|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-0.3|-2.5|0.0125
91587149|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.8|-2.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-2.0|-3.8|<0.0001
91587150|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-2.9|-1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-1.0|-2.9|<0.0001
91587151|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.48||0.0198|TWO_SIDED|95.0|-2.1|-0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-0.2|-2.1|0.0198
91587152|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-3.4|-1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-1.2|-3.4|<0.0001
91587153|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.57||0.0004|TWO_SIDED|95.0|-3.2|-0.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-0.9|-3.2|0.0004
91587154|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57||0.0969|TWO_SIDED|95.0|-2.1|0.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||0.2|-2.1|0.0969
91587155|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-3.7|-1.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-1.3|-3.7|<0.0001
91587156|NCT03816891|183063665|SUPERIORITY||ls|-2.0|STANDARD_ERROR_OF_MEAN|0.62||0.0012|TWO_SIDED|95.0|-3.2|-0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-0.8|-3.2|0.0012
91587157|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.63||0.3212|TWO_SIDED|95.0|-1.9|0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||0.6|-1.9|0.3212
91587158|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.61||0.0011|TWO_SIDED|95.0|-3.2|-0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-0.8|-3.2|0.0011
91587159|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.61||0.0044|TWO_SIDED|95.0|-3.0|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-0.6|-3.0|0.0044
91587160|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.3635|TWO_SIDED|95.0|-1.8|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||0.7|-1.8|0.3635
91780126|NCT01285323|183440458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.1775||0.7263|TWO_SIDED|95.0|-0.411|0.287||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.287|-0.411|0.7263
91780127|NCT01285323|183440461|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.3893|||<|0.0001|TWO_SIDED|95.0|0.2621|0.5782||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5782|0.2621|<0.0001
91587161|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.62||0.0172|TWO_SIDED|95.0|-2.7|-0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-0.3|-2.7|0.0172
91587162|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.63||0.0401|TWO_SIDED|95.0|-2.6|-0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-0.1|-2.6|0.0401
91587163|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.63||0.7627|TWO_SIDED|95.0|-1.4|1.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||1.1|-1.4|0.7627
91587164|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.54||0.0827|TWO_SIDED|95.0|-2.0|0.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||0.1|-2.0|0.0827
91587165|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.55||0.1315|TWO_SIDED|95.0|-1.9|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||0.3|-1.9|0.1315
91587166|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.54||0.6133|TWO_SIDED|95.0|-0.8|1.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||1.4|-0.8|0.6133
91780128|NCT01285323|183440461|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio|0.6686||||0.402|TWO_SIDED|95.0|0.2878|1.6479||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.6479|0.2878|0.4020
91780129|NCT02606643|183440465|SUPERIORITY_OR_OTHER|||||||0.814|||||||Chi-squared|||an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group||||0.814
91780130|NCT02158546|183440470|SUPERIORITY||Least square means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.782|TWO_SIDED|95.0|-2.1|1.6|||Mixed Models Analysis|||||1.6|-2.1|0.782
91780131|NCT03418714|183440485|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||T test on the change in network activity across all networks, from before to after salvinorin A administration.||||.006
91780132|NCT03418714|183440486|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||T test on the change in within- and between-network connectivity across all values, from before to after salvinorin A administration.||||.001
91780133|NCT01208207|183440491|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|-0.64|||||TWO_SIDED|95.0|-5.47|4.19|||ANCOVA|||||4.19|-5.47|
91780134|NCT01208207|183440492|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|1.59|||||TWO_SIDED|95.0|-2.19|5.37|||ANCOVA|||||5.37|-2.19|
91780135|NCT01208207|183440493|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-1.58||||0.396|TWO_SIDED|80.0|-3.96|0.81|||ANCOVA|||||0.81|-3.96|0.396
91587167|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.54||0.3136|TWO_SIDED|95.0|-1.6|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||0.5|-1.6|0.3136
91587168|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3218|TWO_SIDED|95.0|-1.6|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||0.5|-1.6|0.3218
91587169|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6576|TWO_SIDED|95.0|-0.8|1.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||1.3|-0.8|0.6576
91780136|NCT01208207|183440494|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-2.7||||0.112||80.0|-4.88|-0.52|||ANCOVA|||||-0.52|-4.88|0.112
91780137|NCT03060096|183440509|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
91780138|NCT03060096|183440510|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91780139|NCT03060096|183440511|OTHER||Rate|0.764|||||ONE_SIDED|95.0|0.6783||||||||||0.6783|
91780140|NCT01055197|183440523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.2103|TWO_SIDED|95.0|0.82|2.53|||Log Rank|||The null hypothesis (H0) was that PCI + RT is not effective versus the alternative hypothesis (H1) that PCI + RT is effective. Assumptions were that PCI alone would have hazard rate λc of 1.204 and PCI + RT a hazard rate λc of 0.799 (hazard ratio λt/λc = 0.663). At each planned analysis, the p-value from the log-rank test statistic assessing overall survival was compared to the nominal significance level. The final targeted accrual was 154.||2.53|0.82|0.2103
91780141|NCT01055197|183440524|SUPERIORITY|||||||0.24|||||||Fisher Exact|2-sided significance level of 0.05||||||0.24
91780142|NCT01055197|183440526|SUPERIORITY|||||||0.0102|||||||Log Rank|2-sided significance level of 0.05||||||0.0102
91780143|NCT01721044|183440543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
91780144|NCT01721044|183440544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91780145|NCT01721044|183440545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91780146|NCT01721044|183440546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.140
91780147|NCT01721044|183440547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
91780148|NCT01721044|183440548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91780149|NCT01721044|183440549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91780150|NCT01721044|183440550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.723|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.723
91780151|NCT01721044|183440551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
91780152|NCT01721044|183440551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
91780153|NCT01721044|183440552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
91780154|NCT01721044|183440552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
91780155|NCT01721044|183440552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
91780156|NCT01721044|183440552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.015
91780157|NCT01721044|183440553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
91780158|NCT01721044|183440553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
91780159|NCT01721044|183440553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
91780160|NCT01721044|183440553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
91780161|NCT01721044|183440554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780162|NCT01721044|183440554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780163|NCT01721044|183440555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780164|NCT01721044|183440555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.009
91780165|NCT01721044|183440556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780166|NCT01721044|183440556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.003
91780167|NCT01721044|183440557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.012
91587170|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.55||0.1565|TWO_SIDED|95.0|-1.9|0.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||0.3|-1.9|0.1565
91780168|NCT01721044|183440557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.104
91780169|NCT01721044|183440558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.002
91780170|NCT01721044|183440558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.004
91780171|NCT01721044|183440559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780172|NCT01721044|183440559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.018
91780173|NCT01721044|183440560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780174|NCT01721044|183440560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
91780175|NCT01721044|183440561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.005
91780176|NCT01721044|183440561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.004
91780177|NCT01721044|183440561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.002
91780178|NCT01721044|183440561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.026
91780179|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.448|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.448
91780180|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.058
91780181|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.446
91780182|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.401
91780183|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
91780184|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
91780185|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
91780186|NCT01721044|183440562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
91780187|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
91587171|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.55||0.228|TWO_SIDED|95.0|-1.7|0.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||0.4|-1.7|0.2280
91780188|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
91780189|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.001
91780190|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.003
91780191|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
91780192|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
91780193|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.001
91780194|NCT01721044|183440563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.002
91780195|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.362
91780196|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.170
91780197|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.753
91780198|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.715
91780199|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.077
91780200|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.058
91780201|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.232|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.232
91780202|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.534
91780203|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.079
91780204|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.070
91780205|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.327
91780206|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.479
91780207|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.001
91780208|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.005
91780209|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.001
91780210|NCT01721044|183440564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.030
91780211|NCT02048670|183440579|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||Condition 1 - eyes open, visual surround locked, platform locked||||0.005
91780212|NCT02048670|183440579|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||Condition 2 - eyes closed, visual surround locked, platform locked||||0.006
91780213|NCT02048670|183440579|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||Condition 3 - eyes open, visual surround unlocked, platform locked||||0.051
91780214|NCT02048670|183440579|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|||Condition 4 - eyes open, visual surround locked, platform unlocked||||0.173
91780215|NCT02048670|183440579|SUPERIORITY|||||||0.985|||||||Kruskal-Wallis|||Condition 5 - eyes closed, visual surround locked, platform unlocked||||0.985
91780216|NCT02048670|183440579|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||Condition 6 - eyes open, visual surround unlocked, platform unlocked||||0.003
91780217|NCT02420821|183440587|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0205|TWO_SIDED|95.0|0.57|0.95|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.95|0.57|0.0205
91780218|NCT02420821|183440589|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2675|TWO_SIDED|95.0|0.76|1.08|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.08|0.76|0.2675
91780219|NCT02420821|183440591|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.263|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.13|0.64|0.263
91780220|NCT02420821|183440593|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1218|TWO_SIDED|95.0|0.74|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.04|0.74|0.1218
91780221|NCT02420821|183440595|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6138|TWO_SIDED|95.0|0.72|1.21|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.21|0.72|0.6138
91780222|NCT02420821|183440596|SUPERIORITY||Difference in Response Rates|3.3||||0.2733|TWO_SIDED|95.0|-3.09|9.7|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||9.70|-3.09|0.2733
91780223|NCT02420821|183440598|SUPERIORITY||Difference in Response Rates|1.96||||0.5121|TWO_SIDED|95.0|-4.32|8.24|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||8.24|-4.32|0.5121
91780224|NCT02420821|183440601|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0606|TWO_SIDED|95.0|0.71|1.01|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.01|0.71|0.0606
91780225|NCT02420821|183440602|SUPERIORITY||Difference in Response Rates|5.09||||0.1011|TWO_SIDED|95.0|-1.4|11.58|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||11.58|-1.40|0.1011
91780226|NCT02420821|183440605|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0254|TWO_SIDED|95.0|0.7|0.98|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.98|0.70|0.0254
91780227|NCT02420821|183440607|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.002|TWO_SIDED|95.0|0.34|0.79|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.79|0.34|0.0020
91780228|NCT02420821|183440609|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0497|TWO_SIDED|95.0|0.43|1.0|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.00|0.43|0.0497
91780229|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.43|-1.06|<0.0001
91780230|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.2||||0.2085|TWO_SIDED|95.0|-0.51|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-0.51|0.2085
91780231|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.71|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.71|-1.33|<0.0001
91780232|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.51||||0.0013|TWO_SIDED|95.0|-0.82|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-0.82|0.0013
91587172|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.94|TWO_SIDED|95.0|-1.0|1.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||1.1|-1.0|0.9400
91587173|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.276|TWO_SIDED|95.0|-1.8|0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||0.5|-1.8|0.2760
91587174|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.4096|TWO_SIDED|95.0|-1.6|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||0.7|-1.6|0.4096
91587175|NCT03816891|183063665|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.8177|TWO_SIDED|95.0|-1.0|1.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||1.3|-1.0|0.8177
91587176|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-145.0|STANDARD_ERROR_OF_MEAN|36.24||0.0001|TWO_SIDED|95.0|-216.6|-73.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-73.3|-216.6|0.0001
91780233|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.7|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.70|-1.34|<0.0001
91780234|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.43||||0.0098|TWO_SIDED|95.0|-0.76|-0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.10|-0.76|0.0098
91780235|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.65|-1.32|<0.0001
91780236|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.46||||0.008|TWO_SIDED|95.0|-0.8|-0.12|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.12|-0.80|0.0080
91780237|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.44|-1.13|<0.0001
91780238|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.21||||0.2512|TWO_SIDED|95.0|-0.56|0.15|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.15|-0.56|0.2512
91780239|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.65||||0.0005|TWO_SIDED|95.0|-1.01|-0.28|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.28|-1.01|0.0005
91780240|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.43||||0.0247|TWO_SIDED|95.0|-0.8|-0.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.05|-0.80|0.0247
91587177|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-106.4|STANDARD_ERROR_OF_MEAN|35.82||0.0035|TWO_SIDED|95.0|-177.2|-35.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-35.5|-177.2|0.0035
91587178|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-109.9||||0.0031|TWO_SIDED|95.0|-182.2|-37.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 2||-37.6|-182.2|0.0031
91587179|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-75.8|STANDARD_ERROR_OF_MEAN|14.9|<|0.0001|TWO_SIDED|95.0|-105.2|-46.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-46.4|-105.2|<0.0001
91587180|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-55.4|STANDARD_ERROR_OF_MEAN|15.14||0.0003|TWO_SIDED|95.0|-85.3|-25.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-25.5|-85.3|0.0003
91587181|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-43.3|STANDARD_ERROR_OF_MEAN|0.0053||0.0053|TWO_SIDED|95.0|-73.5|-13.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-13.1|-73.5|0.0053
91780241|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.39|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.39|-1.15|<0.0001
91780242|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.29||||0.1411|TWO_SIDED|95.0|-0.68|0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.10|-0.68|0.1411
91780243|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.65||||0.0014|TWO_SIDED|95.0|-1.05|-0.25|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.25|-1.05|0.0014
91780244|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.37||||0.0728|TWO_SIDED|95.0|-0.78|0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.03|-0.78|0.0728
91780245|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.49|-1.32|<0.0001
91587182|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|21.28||0.0472|TWO_SIDED|95.0|-84.6|-0.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-0.5|-84.6|0.0472
91587183|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-54.0|STANDARD_ERROR_OF_MEAN|21.11||0.0115|TWO_SIDED|95.0|-95.7|-12.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-12.3|-95.7|0.0115
91587184|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|21.28||0.1453|TWO_SIDED|95.0|-73.2|10.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||10.9|-73.2|0.1453
91647582|NCT01032330|183187139|OTHER|||||||0.61|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.61
91647583|NCT01032330|183187140|OTHER|||||||0.012|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.012
91780246|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.62||||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-1.05|0.0041
91647584|NCT01032330|183187140|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
91709020|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.205||0.6028||95.0|-0.34|0.56|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.56|-0.34|0.6028
91780247|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.55|-1.46|<0.0001
91587185|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-88.1|STANDARD_ERROR_OF_MEAN|27.58||0.0017|TWO_SIDED|95.0|-142.5|-33.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-33.6|-142.5|0.0017
91587186|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-71.7|STANDARD_ERROR_OF_MEAN|27.87||0.011|TWO_SIDED|95.0|-126.8|-16.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-16.7|-126.8|0.0110
91780248|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.5||||0.0353|TWO_SIDED|95.0|-0.96|-0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.03|-0.96|0.0353
91780249|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.85||||0.0011|TWO_SIDED|95.0|-1.35|-0.34|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.34|-1.35|0.0011
91780250|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.5||||0.0582|TWO_SIDED|95.0|-1.01|0.02|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.02|-1.01|0.0582
91780251|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.76||||0.0089|TWO_SIDED|95.0|-1.32|-0.19|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.19|-1.32|0.0089
91780252|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.02||||0.9575|TWO_SIDED|95.0|-0.57|0.61|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.61|-0.57|0.9575
91780253|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.36||||0.2745|TWO_SIDED|95.0|-1.01|0.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.29|-1.01|0.2745
91780254|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.13||||0.7088|TWO_SIDED|95.0|-0.81|0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.55|-0.81|0.7088
91780255|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.39||||0.3077|TWO_SIDED|95.0|-1.13|0.36|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.36|-1.13|0.3077
91780256|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.15||||0.7112|TWO_SIDED|95.0|-0.93|0.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.63|-0.93|0.7112
91587187|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-52.3|STANDARD_ERROR_OF_MEAN|28.46||0.0681|TWO_SIDED|95.0|-108.5|3.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||3.9|-108.5|0.0681
91587188|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-45.0|STANDARD_ERROR_OF_MEAN|13.79||0.0013|TWO_SIDED|95.0|-72.3|-17.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-17.8|-72.3|0.0013
91587189|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-34.0|STANDARD_ERROR_OF_MEAN|13.96||0.0161|TWO_SIDED|95.0|-61.5|-6.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-6.4|-61.5|0.0161
91587190|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|14.02||0.2466|TWO_SIDED|95.0|-44.0|11.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||11.4|-44.0|0.2466
91780257|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|-0.79||||0.0837|TWO_SIDED|95.0|-1.69|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-1.69|0.0837
91780258|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.08||||0.8655|TWO_SIDED|95.0|-0.88|1.04|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.04|-0.88|0.8655
91780259|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.02||||0.9725|TWO_SIDED|95.0|-1.07|1.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.11|-1.07|0.9725
91587191|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-32.7|STANDARD_ERROR_OF_MEAN|16.17||0.0451|TWO_SIDED|95.0|-64.6|-0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-0.7|-64.6|0.0451
91587192|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|16.43||0.177|TWO_SIDED|95.0|-54.8|10.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||10.2|-54.8|0.1770
91587193|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|16.54||0.6893|TWO_SIDED|95.0|-39.3|26.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||26.1|-39.3|0.6893
91587194|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-37.3|STANDARD_ERROR_OF_MEAN|14.02||0.0087|TWO_SIDED|95.0|-65.0|-9.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-9.6|-65.0|0.0087
91780260|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.38||||0.5285|TWO_SIDED|95.0|-0.8|1.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.55|-0.80|0.5285
91780261|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.03||||0.9663|TWO_SIDED|95.0|-1.34|1.4|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.40|-1.34|0.9663
91780262|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.01||||0.9914|TWO_SIDED|95.0|-1.61|1.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.63|-1.61|0.9914
91780263|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.22||||0.8345|TWO_SIDED|95.0|-1.85|2.3|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.30|-1.85|0.8345
91780264|NCT02420821|183440610|SUPERIORITY||LS Mean Difference|0.5||||0.7725|TWO_SIDED|95.0|-2.9|3.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||3.91|-2.90|0.7725
91780265|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.49||||0.001|TWO_SIDED|95.0|-0.77|-0.2|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.20|-0.77|0.0010
91587195|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|14.4||0.0439|TWO_SIDED|95.0|-57.7|-0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-0.8|-57.7|0.0439
91647585|NCT01032330|183187141|OTHER|||||||0.002|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||.002
91647586|NCT01032330|183187141|OTHER|||||||0.01|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.01
91647587|NCT01032330|183187142|OTHER|||||||0.11|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.11
91647588|NCT01032330|183187142|OTHER|||||||0.1|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.10
91647589|NCT01032330|183187143|OTHER|||||||0.6|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.60
91647590|NCT01032330|183187143|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
91647591|NCT02567266|183187151|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.338|TWO_SIDED|95.0|-0.58|0.2||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post-Treatment||.20|-.58|.338
91780266|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.34|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.34|-0.91|<0.0001
91780267|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.69|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.69|-1.13|<0.0001
91780268|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.52||||0.0002|TWO_SIDED|95.0|-0.79|-0.25|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.25|-0.79|0.0002
91780269|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.29|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.29|-0.84|<0.0001
91647592|NCT02567266|183187151|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.2||0.425|TWO_SIDED|95.0|-0.24|0.57||Threshold: p \<.05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post Treatment||0.57|-0.24|0.425
91647593|NCT02567266|183187151|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.77|0.06||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post||0.06|-0.77|0.09
91647594|NCT02567266|183187151|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.2||0.126|TWO_SIDED|95.0|-0.72|0.09||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.09|-0.72|0.126
91647595|NCT02567266|183187151|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.28|TWO_SIDED|95.0|-0.65|0.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.19|-0.65|0.28
91647596|NCT02567266|183187151|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.697|TWO_SIDED|95.0|-0.51|0.34||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.34|-0.51|0.697
91647597|NCT02567266|183187152|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.779|TWO_SIDED|95.0|-0.6|0.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.45|-0.6|0.779
91647598|NCT02567266|183187152|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.27||0.66|TWO_SIDED|95.0|-0.42|0.67||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.67|-0.42|0.66
91587196|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|14.33||0.511|TWO_SIDED|95.0|-37.8|18.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||18.9|-37.8|0.5110
91780270|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.32|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.32|-0.81|<0.0001
91780271|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.33||||0.0036|TWO_SIDED|95.0|-0.56|-0.11|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.11|-0.56|0.0036
91587197|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|14.76||0.0592|TWO_SIDED|95.0|-57.2|1.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||1.1|-57.2|0.0592
91587198|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-18.2|STANDARD_ERROR_OF_MEAN|15.21||0.2327|TWO_SIDED|95.0|-48.3|11.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||11.8|-48.3|0.2327
91587199|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|15.16||0.8173|TWO_SIDED|95.0|-33.5|26.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||26.4|-33.5|0.8173
91587200|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|15.06||0.0725|TWO_SIDED|95.0|-57.1|2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||2.5|-57.1|0.0725
91587201|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-23.3|STANDARD_ERROR_OF_MEAN|15.25||0.1285|TWO_SIDED|95.0|-53.5|6.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||6.8|-53.5|0.1285
91587202|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|14.82||0.6911|TWO_SIDED|95.0|-35.2|23.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||23.4|-35.2|0.6911
91587203|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-18.4|STANDARD_ERROR_OF_MEAN|15.24||0.2283|TWO_SIDED|95.0|-48.6|11.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||11.7|-48.6|0.2283
91780272|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.91|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.91|-1.46|<0.0001
91780273|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.54||||0.0001|TWO_SIDED|95.0|-0.81|-0.27|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.27|-0.81|0.0001
91780274|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.71|-1.28|<0.0001
91587204|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|15.6||0.3049|TWO_SIDED|95.0|-46.9|14.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||14.8|-46.9|0.3049
91587205|NCT03816891|183063666|SUPERIORITY||LS Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|15.62||0.7172|TWO_SIDED|95.0|-36.6|25.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||25.2|-36.6|0.7172
91587206|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001|TWO_SIDED|95.0|-24.1|-12.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-12.0|-24.1|<0.0001
91587207|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|3.08||0.0002|TWO_SIDED|95.0|-17.8|-5.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-5.6|-17.8|0.0002
91780275|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.33|-0.87|<0.0001
91780276|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.41|-0.75|<0.0001
91780277|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.34||||0.0051|TWO_SIDED|95.0|-0.58|-0.1|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.10|-0.58|0.0051
91780278|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-1.08|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.83|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.83|-1.33|<0.0001
91780279|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-0.05||||0.6541|TWO_SIDED|95.0|-0.26|0.16|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||0.16|-0.26|0.6541
91780280|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.76|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.76|-1.28|<0.0001
91780281|NCT02420821|183440611|SUPERIORITY||LS Mean Difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.88|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.88|-1.27|<0.0001
91780282|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.73|||<|0.0001|TWO_SIDED|95.0|0.58|0.87|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.87|0.58|<0.0001
91780283|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.57|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.57|0.28|<0.0001
91780284|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.84|0.55|<0.0001
91587208|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|3.08||0.0017|TWO_SIDED|95.0|-15.9|-3.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-3.8|-15.9|0.0017
91709021|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.491||0.3624||95.0|-0.68|1.64|||ANOVA|||Difference from placebo (including Baseline); Day 8: 5 hours post-dose.||1.64|-0.68|0.3624
91647599|NCT02567266|183187152|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.629|TWO_SIDED|95.0|-0.51|0.31||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.31|-0.51|0.629
91647600|NCT02567266|183187152|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.938|TWO_SIDED|95.0|-0.41|0.38||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.38|-0.41|0.938
91587209|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-21.0|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-28.0|-13.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-13.9|-28.0|<0.0001
91587210|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|3.52||0.0006|TWO_SIDED|95.0|-19.3|-5.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-5.4|-19.3|0.0006
91587211|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.53||0.0497|TWO_SIDED|95.0|-13.9|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||0.0|-13.9|0.0497
91587212|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-20.6|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|95.0|-28.9|-12.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-12.3|-28.9|<0.0001
91587213|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|4.21||0.0002|TWO_SIDED|95.0|-24.6|-8.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-8.0|-24.6|0.0002
91587214|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|4.29||0.0362|TWO_SIDED|95.0|-17.5|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-0.6|-17.5|0.0362
91587215|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-21.0|STANDARD_ERROR_OF_MEAN|3.96|<|0.0001|TWO_SIDED|95.0|-28.8|-13.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-13.2|-28.8|<0.0001
91647601|NCT02567266|183187152|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.68|TWO_SIDED|95.0|-0.32|0.49||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.49|-0.32|0.68
91587216|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|3.98||0.0001|TWO_SIDED|95.0|-23.5|-7.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-7.7|-23.5|0.0001
91587217|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|4.0||0.01|TWO_SIDED|95.0|-18.3|-2.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-2.5|-18.3|0.0100
91587218|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|4.27||0.0035|TWO_SIDED|95.0|-21.1|-4.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-4.3|-21.1|0.0035
91587219|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|4.33||0.0255|TWO_SIDED|95.0|-18.3|-1.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-1.2|-18.3|0.0255
91587220|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|4.31||0.2869|TWO_SIDED|95.0|-13.1|3.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||3.9|-13.1|0.2869
91647602|NCT02567266|183187152|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.479|TWO_SIDED|95.0|-0.75|0.35||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.35|-0.75|0.479
91647603|NCT02567266|183187153|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.58||0.852|TWO_SIDED|95.0|-2.85|3.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.45|-2.85|0.852
91647604|NCT02567266|183187153|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.62||0.917|TWO_SIDED|95.0|-3.41|3.07||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.07|-3.41|0.917
91709022|NCT00978341|183311318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.461||0.3163||95.0|-0.52|1.49|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||1.49|-0.52|0.3163
91587221|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|4.09||0.076|TWO_SIDED|95.0|-15.4|0.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||0.8|-15.4|0.0760
91587222|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|4.15||0.2673|TWO_SIDED|95.0|-12.8|3.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||3.6|-12.8|0.2673
91587223|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|4.14||0.732|TWO_SIDED|95.0|-9.6|6.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||6.8|-9.6|0.7320
91587224|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|4.34||0.0726|TWO_SIDED|95.0|-16.4|0.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||0.7|-16.4|0.0726
91587225|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|4.41||0.4475|TWO_SIDED|95.0|-12.1|5.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||5.4|-12.1|0.4475
91587226|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|4.41||0.6854|TWO_SIDED|95.0|-10.5|6.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||6.9|-10.5|0.6854
91587227|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|4.5||0.3287|TWO_SIDED|95.0|-13.3|4.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||4.5|-13.3|0.3287
91587228|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|4.49||0.9752|TWO_SIDED|95.0|-9.0|8.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||8.7|-9.0|0.9752
91587229|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|4.4||0.5761|TWO_SIDED|95.0|-6.2|11.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||11.2|-6.2|0.5761
91587230|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|4.54||0.2817|TWO_SIDED|95.0|-13.9|4.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||4.1|-13.9|0.2817
91780285|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.44|<0.0001
91587231|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|4.56||0.3554|TWO_SIDED|95.0|-13.3|4.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||4.8|-13.3|0.3554
91647605|NCT02567266|183187153|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.66||0.778|TWO_SIDED|95.0|-2.81|3.74||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.74|-2.81|0.778
91780286|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.77|||<|0.0001|TWO_SIDED|95.0|0.62|0.92|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.92|0.62|<0.0001
91587232|NCT03816891|183063667|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|4.57||0.7713|TWO_SIDED|95.0|-10.4|7.7||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||7.7|-10.4|0.7713
91587233|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|4.01|<|0.0001|TWO_SIDED|95.0|-32.8|-16.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-16.9|-32.8|<0.0001
91587234|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|4.04|<|0.0001|TWO_SIDED|95.0|-24.6|-8.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-8.6|-24.6|<0.0001
91647606|NCT02567266|183187153|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|2.12||0.66|TWO_SIDED|95.0|-3.3|5.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.19|-3.3|0.66
91587235|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-13.3|STANDARD_ERROR_OF_MEAN|4.05||0.0013|TWO_SIDED|95.0|-21.2|-5.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 4||-5.3|-21.2|0.0013
91587236|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-27.8|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-36.5|-19.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-19.1|-36.5|<0.0001
91587237|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|4.35||0.0002|TWO_SIDED|95.0|-25.4|-8.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||-8.2|-25.4|0.0002
91587238|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|4.36||0.0511|TWO_SIDED|95.0|-17.2|0.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 8||0.0|-17.2|0.0511
91587239|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-37.8|-17.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-17.1|-37.8|<0.0001
91587240|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-21.9|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-32.3|-11.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-11.5|-32.3|<0.0001
91587241|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|5.37||0.0386|TWO_SIDED|95.0|-21.8|-0.6||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 12||-0.6|-21.8|0.0386
91587242|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|95.0|-37.8|-18.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-18.4|-37.8|<0.0001
91587243|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|4.93|<|0.0001|TWO_SIDED|95.0|-31.0|-11.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-11.5|-31.0|<0.0001
91780287|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.46|0.78|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.78|0.46|<0.0001
91780288|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.97|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.97|0.66|<0.0001
91780289|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.81|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.81|0.49|<0.0001
91780290|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.83|||<|0.0001|TWO_SIDED|95.0|0.66|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.66|<0.0001
91780291|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.46|0.8|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.80|0.46|<0.0001
91587244|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|4.95||0.0108|TWO_SIDED|95.0|-22.5|-3.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 16||-3.0|-22.5|0.0108
91587245|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|5.39||0.0006|TWO_SIDED|95.0|-29.6|-8.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-8.4|-29.6|0.0006
91587246|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|5.45||0.0084|TWO_SIDED|95.0|-25.3|-3.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||-3.8|-25.3|0.0084
91587247|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.43||0.2422|TWO_SIDED|95.0|-17.1|4.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 18||4.4|-17.1|0.2422
91587248|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|5.17||0.0249|TWO_SIDED|95.0|-21.9|-1.5||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||-1.5|-21.9|0.0249
91647607|NCT02567266|183187153|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|2.19||0.935|TWO_SIDED|95.0|-4.55|4.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||4.19|-4.55|0.935
91521232|NCT02954354|182917044|SUPERIORITY|||||||0.5414||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.5414
91587249|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|5.24||0.1497|TWO_SIDED|95.0|-17.9|2.8||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||2.8|-17.9|0.1497
91587250|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|5.23||0.691|TWO_SIDED|95.0|-12.4|8.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 20||8.2|-12.4|0.6910
91587251|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|5.68||0.0331|TWO_SIDED|95.0|-23.4|-1.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||-1.0|-23.4|0.0331
91647608|NCT02567266|183187153|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.21||0.615|TWO_SIDED|95.0|-3.29|5.55||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.55|-3.29|0.615
91587252|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.77||0.3709|TWO_SIDED|95.0|-16.6|6.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||6.2|-16.6|0.3709
91587253|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|5.77||0.6924|TWO_SIDED|95.0|-13.7|9.1||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 32||9.1|-13.7|0.6924
91587254|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|5.78||0.1583|TWO_SIDED|95.0|-19.6|3.2||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||3.2|-19.6|0.1583
91587255|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|5.77||0.7193|TWO_SIDED|95.0|-13.5|9.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||9.3|-13.5|0.7193
91587256|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.64||0.7589|TWO_SIDED|95.0|-9.4|12.9||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 48||12.9|-9.4|0.7589
91587257|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|5.91||0.1642|TWO_SIDED|95.0|-20.0|3.4||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||3.4|-20.0|0.1642
91587258|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|5.94||0.2611|TWO_SIDED|95.0|-18.4|5.0||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||5.0|-18.4|0.2611
91587259|NCT03816891|183063668|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|5.94||0.8076|TWO_SIDED|95.0|-13.2|10.3||Estimated from ANCOVA models with treatment and randomization stratification factors of sex and years since the first nodule observed (i.e., ≥10 vs. \<10 years) as fixed effect factors, baseline as covariate.|ANCOVA|||Week 52||10.3|-13.2|0.8076
91587260|NCT02961218|183063687|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.57||0.55|TWO_SIDED|90.0|-1.03|0.85||probability reduction of average pain score in ACZ885 \> Placebo|Bayesian model for repeated measures||Lower limit and upper limit represents the credibility interval from the Bayesian analysis.|||0.85|-1.03|0.55
91587261|NCT02961218|183063689|SUPERIORITY||Ratio|0.408||||0.002|TWO_SIDED|90.0|0.253|0.658|||Mixed-effect Model for Repeated Measures|||||0.658|0.253|0.002
91587262|NCT02961218|183063690|SUPERIORITY||Ratio|0.752|||<|0.001|TWO_SIDED|90.0|0.657|0.862|||Mixed-effect Model for Repeated Measures|||||0.862|0.657|<.001
91587263|NCT02961218|183063691|SUPERIORITY||Ratio|0.682||||0.004|TWO_SIDED|90.0|0.547|0.849|||Mixed-effect Model for Repeated Measures|||||0.849|0.547|0.004
91587264|NCT02961218|183063692|SUPERIORITY||Ratio|0.718||||0.032|TWO_SIDED|90.0|0.556|0.925|||Mixed-effect Model for Repeated Measures|||||0.925|0.556|0.032
91587265|NCT02961218|183063699|SUPERIORITY||Ratio|1.4|STANDARD_ERROR_OF_MEAN|0.45||0.455|TWO_SIDED|90.0|0.58|3.4|||Generalized Linear Model (GLM)|||||3.40|0.58|0.455
91587266|NCT05135000|183063762|OTHER||Cox Proportional Hazard|0.7||||0.6843|TWO_SIDED|80.0|0.2|2.8|||Log Rank|||||2.8|0.2|0.6843
91613578|NCT01899144|183121465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.2|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|11.6|30.81|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||30.81|11.6|<0.0001
91587267|NCT04417127|183063764|SUPERIORITY|Analysis of the primary outcome was conducted using a doubly-robust generalized estimating equation (GEE) with a logit link function. Multiple imputation was used to account for missing data on baseline covariates; Rubin's rule was used for variance estimation. The GEE model included the intervention arm, used an independence working correlation matrix and variance was estimated using a sandwich variance estimator for clustered data.|Odds Ratio, log|0.84||||0.23|TWO_SIDED|95.0|0.63|1.12||Baseline values of variables (county, gender, age, education, income, viral load) were used for differential dropout adjustment for the primary comparison and differential dropout and confounding adjustments for comparisons to matched participants.|Wald test|Hypothesis: Microfinance with Integrated, Community-based Care \> Microfinance with Usual Care in terms of viral suppression at 18-months.|The intervention effect was estimated using the log odds ratio coefficient associated with the intervention in the GEE. The primary hypothesis test of intervention effect was conducted using a Wald test and 95% Wald-based confidence intervals.|For the primary outcome, the primary analysis was an intention-to-treat analysis that included all randomized participants comparing viral suppression at 18-months. Following studies of the effect of financial interventions, we powered the study to have at least 80% power to detect a 15% additive increase in viral suppression among microfinance group members receiving integrated community care compared to those receiving facility-based care, assuming 15% dropout.||1.12|0.63|0.23
91587268|NCT04417127|183063764|SUPERIORITY||Odds Ratio, log|2.16|||<|0.001|TWO_SIDED|95.0|1.48|3.19||Hypothesis: Microfinance with Integrated, Community-based Care \> Usual (Facility-based) Care in terms of viral suppression at 18-months.|Wald test|||A secondary analysis of the primary outcome included a comparison of viral suppression at 18- months, between each of the two randomized trial arms and the non-randomized, prospectively-followed, frequency-matched participants who were not engaged in microfinance. The secondary analysis used the same analytic model as the primary analysis, assuming no clustering in the non-randomized sample.||3.19|1.48|<0.001
91587269|NCT04417127|183063764|SUPERIORITY||Odds Ratio, log|1.42||||0.023|TWO_SIDED|95.0|1.05|1.92||Hypothesis: Microfinance with Usual (Facility-based) Care \> Usual (Facility-based) Care in terms of viral suppression at 18-months.|Wald test|||A secondary analysis of the primary outcome included a comparison of viral suppression at 18- months, between each of the two randomized trial arms and the non-randomized, prospectively-followed, frequency-matched participants who were not engaged in microfinance. The secondary analysis used the same analytic model as the primary analysis, assuming no clustering in the non-randomized sample.||1.92|1.05|0.023
91587270|NCT04417127|183063765|SUPERIORITY||Odds Ratio, log|3.31|||<|0.001|TWO_SIDED|95.0|2.58|4.26|||Wald test|||The retention in care analysis was an intention-to-treat analysis that included all enrolled participants and used the same analysis methods as those for the viral suppression (primary outcome) analysis. The retention in care analyses were not adjusted for multiplicity and should be considered hypothesis generating.||4.26|2.58|<0.001
91587271|NCT04417127|183063765|SUPERIORITY||Odds Ratio, log|7.51|||<|0.001|TWO_SIDED|95.0|6.0|9.55|||Wald test|||The retention in care analysis was an intention-to-treat analysis that included all enrolled participants and used the same analysis methods as those for the viral suppression (primary outcome) analysis. The retention in care analyses were not adjusted for multiplicity and should be considered hypothesis generating.||9.55|6.00|<0.001
91587272|NCT04417127|183063765|SUPERIORITY||Odds Ratio, log|2.56|||<|0.001|TWO_SIDED|95.0|2.14|3.06|||Wald test|||The retention in care analysis was an intention-to-treat analysis that included all enrolled participants and used the same analysis methods as those for the viral suppression (primary outcome) analysis. The retention in care analyses were not adjusted for multiplicity and should be considered hypothesis generating.||3.06|2.14|<0.001
91587273|NCT04417127|183063766|SUPERIORITY||Mean Difference (Final Values)|-0.206|||||TWO_SIDED|95.0|-2.595|2.183|||Wald test|||||2.183|-2.595|
91587274|NCT04417127|183063767|SUPERIORITY||Mean Difference (Final Values)|-0.4478|||||TWO_SIDED|95.0|-0.701|-0.194|||Wald test|||||-0.194|-0.701|
91709023|NCT00978341|183311319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|9.738||0.5919||95.0|-16.26|27.04|||ANOVA|||Difference from placebo (including Baseline); Day 1.||27.04|-16.26|0.5919
91587275|NCT03566810|183063809|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric Least Square(LS)Mean%|98.69|||||TWO_SIDED|90.0|92.2|105.64||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||105.64|92.20|
91587276|NCT03566810|183063809|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|99.39|||||TWO_SIDED|90.0|93.15|106.05||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||106.05|93.15|
91587277|NCT03566810|183063810|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.92|||||TWO_SIDED|90.0|91.08|107.44||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||107.44|91.08|
91587278|NCT03566810|183063810|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|96.89|||||TWO_SIDED|90.0|89.87|104.46||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.46|89.87|
91587279|NCT03566810|183063811|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.0||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||0.00|-0.50|
91780292|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.54|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.54|<0.0001
91709024|NCT00978341|183311319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.58|STANDARD_ERROR_OF_MEAN|14.603||0.3981||95.0|-17.7|42.87|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||42.87|-17.70|0.3981
91709025|NCT00978341|183311319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|12.123||0.8314||95.0|-24.0|29.28|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||29.28|-24.00|0.8314
91709026|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.7569||95.0|-0.14|0.1|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||0.10|-0.14|0.7569
91587280|NCT03566810|183063811|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.5||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||0.50|-0.50|
91587281|NCT03566810|183063813|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|97.89|||||TWO_SIDED|90.0|91.38|104.86||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||104.86|91.38|
91587282|NCT03566810|183063813|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.08|||||TWO_SIDED|90.0|92.37|104.14||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.14|92.37|
91587283|NCT01444651|183063832|SUPERIORITY_OR_OTHER||beta estimate|-1.25|STANDARD_ERROR_OF_MEAN|1.29||0.34|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.||||0.34
91587284|NCT01444651|183063833|SUPERIORITY_OR_OTHER||beta estimate|0.96|STANDARD_ERROR_OF_MEAN|0.68||0.18|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.18
91587285|NCT01444651|183063834|SUPERIORITY_OR_OTHER||beta estimate|-0.18|STANDARD_ERROR_OF_MEAN|0.58||0.76|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.||||0.76
91587286|NCT01444651|183063835|SUPERIORITY_OR_OTHER||beta estimate|1.48|STANDARD_ERROR_OF_MEAN|0.77||0.06|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.06
91587287|NCT01444651|183063836|SUPERIORITY_OR_OTHER||beta estimate|3.76|STANDARD_ERROR_OF_MEAN|1.38||0.009|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.009
91587288|NCT01444651|183063837|SUPERIORITY_OR_OTHER||beta estimate|8.09|STANDARD_ERROR_OF_MEAN|4.05||0.05|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.05
91587289|NCT02952001|183063896|SUPERIORITY|||||||0.562||||||The a priori threshold for statistical significance was 0.050. No adjustments made or required for multiplicity.|Log-rank chi-square test|||The null hypothesis of no difference in the survival time distributions was tested.||||0.562
91587290|NCT00148954|183063900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.003|TWO_SIDED|95.0|1.11|1.62|||Regression, Cox|||||1.62|1.11|0.003
91780293|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.3|0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.65|0.30|<0.0001
91780294|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.49|<0.0001
91587291|NCT01681628|183063904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|16.1|24.0||This was an a priori threshold.|t-test, 2 sided|||Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.||24.0|16.1|<0.001
91587292|NCT01681628|183063904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.4|STANDARD_DEVIATION|14.7|<|0.001|TWO_SIDED|95.0|29.1|34.7|||t-test, 2 sided|||Change in PCL-C scores from before to after treatment.||34.7|29.1|<0.001
91587293|NCT01681628|183063904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_DEVIATION|14.2|<|0.001|TWO_SIDED|95.0|11.4|17.1|||t-test, 2 sided|||Changes in PCL-C scores for control group after no treatment.||17.1|11.4|<0.001
91587294|NCT01681628|183063904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_DEVIATION|13.5|<|0.001|TWO_SIDED|95.0|17.1|22.5|||t-test, 2 sided|Degrees of freedom 94||Change in control group PCL-C scores after treatment, that is from time 2 to time 3.||22.5|17.1|<0.001
91587295|NCT01681628|183063905|SUPERIORITY_OR_OTHER||percentage of participants|65.7|||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-squared test of any change in PCL-C from time 1 to time 2.||||<0.001
91587296|NCT01681628|183063905|SUPERIORITY_OR_OTHER||% of participants with PCL score > 50|41.0|||<|0.001|TWO_SIDED||||||Chi-squared|||Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.||||<0.001
91587297|NCT01681628|183063905|SUPERIORITY_OR_OTHER||Percentage|39.9|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91709027|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4814||95.0|-0.26|0.13|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.13|-0.26|0.4814
91709028|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.143||0.6222||95.0|-0.37|0.23|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.23|-0.37|0.6222
91780295|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.29|0.66|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.66|0.29|<0.0001
91587298|NCT01681628|183063906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|||<|0.001|TWO_SIDED|95.0|15.2|20.5|||t-test, 2 sided|||Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.||20.5|15.2|<0.001
91587299|NCT04796896|183063927|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if:~The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.224|||||TWO_SIDED|95.0|1.061|1.413||||||||1.413|1.061|
91587300|NCT04796896|183063928|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|0.995|||||TWO_SIDED|95.0|0.87|1.139||||||||1.139|0.870|
91587301|NCT04796896|183063928|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.257|||||TWO_SIDED|95.0|1.101|1.434||||||||1.434|1.101|
91587302|NCT04796896|183063929|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.3|||||TWO_SIDED|95.0|-2.2|1.6||||||||1.6|-2.2|
91587303|NCT04796896|183063930|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.4|||||TWO_SIDED|95.0|-2.5|1.5||||||||1.5|-2.5|
91587304|NCT04796896|183063930|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4||||||||2.4|-0.8|
91587305|NCT04796896|183063931|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.897|||||TWO_SIDED|95.0|3.158|4.808||||||||4.808|3.158|
91780296|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.41|0.79|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.79|0.41|<0.0001
91587306|NCT04796896|183063931|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.982|||||TWO_SIDED|95.0|3.404|4.657||||||||4.657|3.404|
91587307|NCT04796896|183063933|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-4.4|2.4||||||||2.4|-4.4|
91587308|NCT04796896|183063933|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-2.2|2.4||||||||2.4|-2.2|
91587309|NCT04796896|183063942|OTHER|The 95% confidence interval (CI) of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.706|||||TWO_SIDED|95.0|0.325|0.873|||||Vaccine efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.873|0.325|
91587310|NCT04796896|183063942|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.409|||||TWO_SIDED|95.0|0.287|0.509|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.509|0.287|
91587311|NCT04796896|183063942|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.324|||||TWO_SIDED|95.0|0.127|0.474|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.474|0.127|
91587312|NCT04796896|183063943|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.683|||||TWO_SIDED|95.0|0.151|0.882|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.882|0.151|
91587313|NCT04796896|183063943|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.281|||||TWO_SIDED|95.0|-0.007|0.48|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.480|-0.007|
91709029|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.113||0.3035||95.0|-0.35|0.12|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.12|-0.35|0.3035
91780297|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.29|<0.0001
91780298|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.52|0.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.91|0.52|<0.0001
91780299|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.53|||<|0.0001|TWO_SIDED|95.0|0.33|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.33|<0.0001
91521233|NCT02954354|182917044|SUPERIORITY|||||||0.2079||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.2079
91521234|NCT02954354|182917044|SUPERIORITY|||||||0.7771||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||48 hours||||0.7771
91780300|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.51|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|0.51|<0.0001
91780301|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.41|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.41|<0.0001
91521235|NCT02954354|182917044|SUPERIORITY|||||||0.0215||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.0215
91709030|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.122||0.1881||95.0|-0.42|0.09|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||0.09|-0.42|0.1881
91709031|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.072||0.3159||95.0|-0.09|0.24|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.24|-0.09|0.3159
91709032|NCT00978341|183311320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8203||95.0|-0.22|0.27|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||0.27|-0.22|0.8203
91780302|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.49|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.49|<0.0001
91780303|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.42||||0.001|TWO_SIDED|95.0|0.17|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.17|0.0010
91780304|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.32|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.32|<0.0001
91780305|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.52||||0.0005|TWO_SIDED|95.0|0.23|0.82|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.82|0.23|0.0005
91780306|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.56||||0.0008|TWO_SIDED|95.0|0.23|0.88|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.88|0.23|0.0008
91587314|NCT04796896|183063943|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|-0.068|||||TWO_SIDED|95.0|-0.832|0.352|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.352|-0.832|
91587315|NCT04796896|183063944|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.76|||||TWO_SIDED|95.0|-0.416|0.965|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.965|-0.416|
91587316|NCT04796896|183063944|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.466|||||TWO_SIDED|95.0|0.328|0.574|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.574|0.328|
91587317|NCT04796896|183063944|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.432|||||TWO_SIDED|95.0|0.232|0.576|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.576|0.232|
91587318|NCT02021292|183063946|SUPERIORITY||ratio of geometric means|0.84||||0.041|TWO_SIDED|95.0|0.7|0.99|||ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.||0.99|0.70|0.0410
91587319|NCT02021292|183063947|SUPERIORITY||least squares (LS) mean difference|34.04||||0.0326|TWO_SIDED|95.0|2.9|65.2||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline in 6MWD at Week 24 is the same in the placebo and the macitentan group. Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||65.2|2.9|0.0326
91587320|NCT02021292|183063948|SUPERIORITY||least squares (LS) mean difference|-0.39||||0.3492|TWO_SIDED|95.0|-1.21|0.43||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline is the same in the placebo and the macitentan group. Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model.||0.43|-1.21|0.3492
91587321|NCT02021292|183063949|SUPERIORITY||Odds Ratio (OR)|0.212||||0.0962|TWO_SIDED|95.0|0.001|1.464||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is the odds of worsening are the same in the placebo and the macitentan group. Logistic regression is used for Treatment Group vs. Placebo comparison to generate odds ratio, confidence levels, and p-values with treatment and WHO functional class at baseline as factors in the model.||1.464|0.001|0.0962
91587322|NCT02021292|183063950|SUPERIORITY||Model-adjusted geometric mean ratio|0.81||||0.0098|TWO_SIDED|95.0|0.7|0.95||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis (ANCOVA) was applied, including 13 subjects with corrected hemodynamic values.||0.95|0.70|0.0098
91587323|NCT02021292|183063951|SUPERIORITY||Model-adjusted geometric mean ratio|0.79||||0.0061|TWO_SIDED|95.0|0.68|0.93||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.93|0.68|0.0061
91780307|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.33||||0.0591|TWO_SIDED|95.0|-0.01|0.67|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.67|-0.01|0.0591
91780308|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.67||||0.0005|TWO_SIDED|95.0|0.29|1.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.05|0.29|0.0005
91780309|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.3||||0.1378|TWO_SIDED|95.0|-0.09|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|-0.09|0.1378
91587324|NCT02021292|183063952|SUPERIORITY||Geometric mean ratio|0.85||||0.0414|TWO_SIDED|95.0|0.73|0.99||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.99|0.73|0.0414
91780310|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.43||||0.065|TWO_SIDED|95.0|-0.03|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|-0.03|0.0650
91587325|NCT02021292|183063953|SUPERIORITY||least squares (LS) mean difference|37.19||||0.0468|TWO_SIDED|95.0|0.54|73.83||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||||73.83|0.54|0.0468
91587326|NCT04356183|183063954|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91587327|NCT04356183|183063955|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91780311|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.48||||0.0531|TWO_SIDED|95.0|-0.01|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|-0.01|0.0531
91780312|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.93||||0.0011|TWO_SIDED|95.0|0.37|1.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.49|0.37|0.0011
91780313|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.55||||0.0708|TWO_SIDED|95.0|-0.05|1.14|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.14|-0.05|0.0708
91780314|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.58||||0.1078|TWO_SIDED|95.0|-0.13|1.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.29|-0.13|0.1078
91780315|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.62||||0.1487|TWO_SIDED|95.0|-0.22|1.47|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.47|-0.22|0.1487
91780316|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.33||||0.5537|TWO_SIDED|95.0|-0.77|1.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.43|-0.77|0.5537
91780317|NCT02420821|183440614|SUPERIORITY||LS Mean Difference|0.52||||0.5743|TWO_SIDED|95.0|-1.29|2.33|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.33|-1.29|0.5743
91780318|NCT02855125|183440690|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2744|TWO_SIDED|95.0|0.71|1.88|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model .|||1.88|0.71|0.2744
91587328|NCT04356183|183063956|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91587329|NCT01676909|183063977|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.362
91780319|NCT02855125|183440691|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.1431|TWO_SIDED|95.0|0.8|2.14|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model.|||2.14|0.80|0.1431
91780320|NCT04467905|183440696|SUPERIORITY||Mean Difference (Final Values)|-29.9|||<|0.0001|TWO_SIDED|95.0|-40.3|-19.3|||ANCOVA||The mean difference is the difference in adjusted means for the change between baseline value and nadir in the placebo group and the change between baseline and nadir in the etripamil group.|||-19.3|-40.3|<0.0001
91780321|NCT04953728|183440739|SUPERIORITY|||||||0.77306724|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.77306724
91780322|NCT04953728|183440739|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.24
91780323|NCT04953728|183440739|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.45
91780324|NCT04953728|183440739|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.13
91780325|NCT04953728|183440739|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during Sham when compared to baseline||||0.14
91780326|NCT04953728|183440740|SUPERIORITY|||||||0.81019363|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to ST36 25Hz||||0.81019363
91780327|NCT04953728|183440740|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 100Hz||||0.18
91780328|NCT04953728|183440740|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hz||||0.21
91780329|NCT04953728|183440740|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to Sham||||0.58
91780330|NCT04953728|183440740|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hz||||0.18
91780331|NCT04953728|183440740|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hz||||0.18
91780332|NCT04953728|183440740|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to sham||||0.78
91780333|NCT04953728|183440740|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hz||||0.89
91780334|NCT04953728|183440740|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to sham||||0.05
91780335|NCT04953728|183440740|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 25Hz when compared to sham||||0.07
91780336|NCT04953728|183440741|SUPERIORITY|||||||0.00046998|||||||t-test, 2 sided|||ST36 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.00046998
91780337|NCT04953728|183440741|SUPERIORITY|||||||0.74369428|||||||t-test, 2 sided|||ST36 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.74369428
91780338|NCT04953728|183440741|SUPERIORITY|||||||0.09854383|||||||t-test, 2 sided|||PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.09854383
91780339|NCT04953728|183440741|SUPERIORITY|||||||0.24872746|||||||t-test, 2 sided|||PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.24872746
91780340|NCT04953728|183440741|SUPERIORITY|||||||0.04828889|||||||t-test, 2 sided|||Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.04828889
91780341|NCT04953728|183440742|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||ST36 100Hz compared to ST36 25Hz||||0.02
91780342|NCT04953728|183440742|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 100Hz||||0.11
91780343|NCT04953728|183440742|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 25Hz||||0.01
91780344|NCT04953728|183440742|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||ST36 100Hz compared to Sham||||0.04
91780345|NCT04953728|183440742|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 100Hz||||0.11
91780346|NCT04953728|183440742|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 25Hz||||0.23
91780347|NCT04953728|183440742|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||ST36 25Hz compared to Sham||||0.17
91780348|NCT04953728|183440742|SUPERIORITY|||||||0.15|||||||t-test, 1 sided|||PC6 100Hz compared to PC6 25Hz||||0.15
91780349|NCT04953728|183440742|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||PC6 100Hz compared to Sham||||0.43
91780350|NCT04953728|183440742|SUPERIORITY|||||||0.19|||||||t-test, 1 sided|||PC6 25Hz compared to Sham||||0.19
91780351|NCT04953728|183440743|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 100Hz when compared to baseline||||0.87
91780352|NCT04953728|183440743|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 25Hz when compared to baseline||||0.13
91780353|NCT04953728|183440743|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baseline||||0.17
91780354|NCT04953728|183440743|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baseline||||0.88
91780355|NCT04953728|183440743|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during sham when compared to baseline||||0.14
91780356|NCT04953728|183440744|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.007
91780357|NCT04953728|183440744|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.83
91780358|NCT04953728|183440744|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.87
91780359|NCT04953728|183440744|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.004
91780360|NCT04953728|183440744|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during sham when compared to baseline||||0.056
91780361|NCT01646125|183440745|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76|||||TWO_SIDED|90.0|0.35|1.63||||||||1.63|0.35|
91780362|NCT02540629|183440764|EQUIVALENCE|Chi-squared test||||||0.01|||||||Chi-squared|||||||0.01
91780363|NCT03584789|183440862|SUPERIORITY||Odds Ratio (OR)|1.29||||0.08|TWO_SIDED|97.5|0.93|1.8|||Mixed Models Analysis|||||1.80|.93|.08
91780364|NCT03584789|183440862|SUPERIORITY||Odds Ratio (OR)|1.24||||0.18|TWO_SIDED|97.5|0.86|1.79|||Mixed Models Analysis|||||1.79|.86|.18
91780365|NCT03584789|183440863|SUPERIORITY||Odds Ratio (OR)|1.37||||0.71|TWO_SIDED|97.5|0.2|9.44|||Mixed Models Analysis|||||9.44|.20|.71
91780366|NCT03584789|183440863|SUPERIORITY||Odds Ratio (OR)|1.53||||0.62|TWO_SIDED|97.5|0.21|11.0|||Mixed Models Analysis|||||11.00|.21|.62
91780367|NCT03584789|183440864|SUPERIORITY||Median Difference (Net)|-0.07||||0.38|TWO_SIDED|95.0|-0.26|0.12|||Mixed Models Analysis|||||.12|-0.26|.38
91587330|NCT01676909|183063978|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.026
91587331|NCT01676909|183063979|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.032
91587332|NCT01676909|183063980|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.||||.64
91587333|NCT01676909|183063981|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||<.0001
91587334|NCT01676909|183063982|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
91587335|NCT01676909|183063983|SUPERIORITY|||||||0.544|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.544
91587336|NCT01676909|183063984|SUPERIORITY|||||||0.699|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.699
91587337|NCT01676909|183063985|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.006
91587338|NCT01676909|183063986|SUPERIORITY|||||||0.762|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.762
91587339|NCT01676909|183063987|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.326
91587340|NCT01676909|183063988|SUPERIORITY|||||||0.667|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.667
91613916|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
91587341|NCT01676909|183063989|SUPERIORITY|||||||0.142|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.142
91780368|NCT03584789|183440864|SUPERIORITY||Median Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||.17|-0.24|.70
91780369|NCT03584789|183440865|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.79|0.5|||Mixed Models Analysis|||||.50|-0.79|.65
91587342|NCT01676909|183063990|SUPERIORITY|||||||0.342|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.342
91780370|NCT03584789|183440865|SUPERIORITY||Mean Difference (Net)|-0.29||||0.41|TWO_SIDED|95.0|-0.99|0.41|||Mixed Models Analysis|||||.41|-0.99|.41
91780371|NCT00602472|183440889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.73|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.50|-0.73|<0.0001
91780372|NCT00602472|183440890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.56|-0.41|||ANCOVA|||Linagliptin vs. Placebo||-0.41|-0.56|<0.0001
91780373|NCT00602472|183440891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.78|-0.58|||ANCOVA|||Linagliptin vs. Placebo||-0.58|-0.78|<0.0001
91780374|NCT00602472|183440892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.8|-0.59|||ANCOVA|||Linagliptin vs. Placebo||-0.59|-0.80|<0.0001
91780375|NCT00602472|183440893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001||95.0|-18.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-18.1|<0.0001
91780376|NCT00602472|183440894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001||95.0|-22.4|-13.2|||ANCOVA|||Linagliptin vs. Placebo||-13.2|-22.4|<0.0001
91780377|NCT00602472|183440895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-20.3|-11.1|||ANCOVA|||Linagliptin vs. Placebo||-11.1|-20.3|<0.0001
91780378|NCT00602472|183440896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001||95.0|-17.2|-7.1|||ANCOVA|||Linagliptin vs. Placebo||-7.1|-17.2|<0.0001
91780379|NCT00602472|183440897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.51|||<|0.0001||95.0|3.332|9.111|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||9.111|3.332|<0.0001
91780380|NCT00602472|183440899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|||<|0.0001||95.0|1.989|7.327|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||7.327|1.989|<0.0001
91780381|NCT00602472|183440901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001||95.0|2.474|4.562|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||4.562|2.474|<0.0001
91780382|NCT04730271|183440909|NON_INFERIORITY|Test of non-inferiority: Absolute value deviation from plan with ROBOTIC is less than it is with manual instruments (not using ROBOTIC) under a non-inferiority margin of 1.5 degrees|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91780383|NCT04730271|183440910|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
91780384|NCT04730271|183440911|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||||||0.0282
91780385|NCT04730271|183440912|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
91780386|NCT04730271|183440913|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91780387|NCT04730271|183440914|SUPERIORITY|||||||0.633|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 1 year of the procedure.||||0.6330
91780388|NCT04730271|183440914|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Comparison between the proportion of Robotic and Manual subjects who had a serious local adverse event within 1 year of the procedure.||||0.0400
91780389|NCT04730271|183440914|SUPERIORITY|||||||0.4079|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 90 days of the procedure.||||0.4079
91780390|NCT04730271|183440914|SUPERIORITY|||||||0.1262|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local serious adverse event within 90 days of the procedure.||||0.1262
91780391|NCT04730271|183440916|SUPERIORITY|||||||0.6662|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.6662
91780392|NCT04730271|183440916|SUPERIORITY|||||||0.8154|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8154
91780393|NCT04730271|183440917|SUPERIORITY|||||||0.0165|||||||t-test, 2 sided|||Comparison of FJS at 12 weeks||||0.0165
91780394|NCT04730271|183440917|SUPERIORITY|||||||0.1331|||||||t-test, 2 sided|||Comparison of FJS at 1 year||||0.1331
91780395|NCT04730271|183440918|SUPERIORITY|||||||0.1596|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.1596
91780396|NCT04730271|183440918|SUPERIORITY|||||||0.6834|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6834
91780397|NCT04730271|183440919|SUPERIORITY|||||||0.5675|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.5675
91780398|NCT04730271|183440919|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9240
91780399|NCT04730271|183440920|SUPERIORITY|||||||0.4586|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4586
91780400|NCT04730271|183440920|SUPERIORITY|||||||0.6951|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6951
91587343|NCT01676909|183063991|SUPERIORITY|||||||0.563|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.563
91587344|NCT01676909|183063992|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.004
91780401|NCT04730271|183440921|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.8000
91780402|NCT04730271|183440921|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9730
91780403|NCT04730271|183440922|SUPERIORITY|||||||0.4636|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4636
91780404|NCT04730271|183440922|SUPERIORITY|||||||0.8088|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8088
91780405|NCT04730271|183440923|SUPERIORITY|||||||0.4851|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 12 weeks||||0.4851
91780406|NCT04730271|183440923|SUPERIORITY|||||||0.6486|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 1 year||||0.6486
91780407|NCT04730271|183440924|SUPERIORITY|||||||0.8887|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for Pain at rest between ROBOTIC and MANUAL at 1 year||||0.8887
91780408|NCT04730271|183440924|SUPERIORITY|||||||0.4007|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for pain at rest between ROBOTIC and MANUAL at 12 weeks||||0.4007
91780409|NCT04730271|183440924|SUPERIORITY|||||||0.0074|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for pain at rest at 12 weeks||||0.0074
91780410|NCT04730271|183440924|SUPERIORITY|||||||0.0663|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain at rest at 1 year||||0.0663
91780411|NCT04730271|183440924|SUPERIORITY|||||||0.7096|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for Pain with Activity at 1 year||||0.7096
91780412|NCT04730271|183440924|SUPERIORITY|||||||0.5321|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for pain with activity at 12 weeks||||0.5321
91780413|NCT04730271|183440924|SUPERIORITY|||||||0.0709|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 12 weeks||||0.0709
91780414|NCT04730271|183440924|SUPERIORITY|||||||0.1274|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 1 year||||0.1274
91780415|NCT04730271|183440925|SUPERIORITY|||||||0.6745|||||||t-test, 2 sided|||Comparison between the accuracy achieved in the first 10 cases compared to the subsequent cases||||0.6745
91780416|NCT02350296|183440942|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|108.12||||0.1455|TWO_SIDED|94.12|97.57|119.81||"treatment P value reported"|ANOVA||Estimated value and limits are expressed in %|||119.81|97.57|0.1455
91780417|NCT02350296|183440943|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.62||||0.0023|TWO_SIDED|94.12|104.26|117.38||"Treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.38|104.26|0.0023
91780418|NCT02350296|183440944|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.69||||0.0021|TWO_SIDED|94.12|104.35|117.41||"treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.41|104.35|0.0021
91780419|NCT02350296|183440945|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.||||||0.0201|||||||Friedman|||||||0.0201
91780420|NCT01544335|183440956|OTHER||||||<|0.001|||||||Correlation coefficient|The correlation between RVC and ΔL-Dex values was plotted, and the correlation strength was assessed using the Pearson correlation coefficient, r.||||||<0.001
91780421|NCT01532986|183440973|SUPERIORITY||Mean Difference (Final Values)|0.189|||>|0.05|TWO_SIDED|95.0|0.157|0.222|||t-test, 2 sided|||||0.222|0.157|>0.05
91780422|NCT01532986|183440974|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.04|0.08|||t-test, 2 sided|||||0.08|-0.04|>0.05
91780423|NCT01532986|183440975|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.52|0.57|||t-test, 2 sided|||||0.57|-0.52|>0.05
91780424|NCT01532986|183440976|SUPERIORITY||Mean Difference (Final Values)|-0.12|||>|0.05|TWO_SIDED|95.0|-0.34|0.1|||t-test, 2 sided|||||0.10|-0.34|>0.05
91780425|NCT01532986|183440977|SUPERIORITY||Mean Difference (Final Values)|-0.88|||>|0.05|TWO_SIDED|95.0|-2.04|0.29|||t-test, 2 sided|||||0.29|-2.04|>0.05
91780426|NCT01532986|183440978|SUPERIORITY||Mean Difference (Final Values)|1.22|||>|0.05|TWO_SIDED|95.0|-8.02|10.46|||t-test, 2 sided|||||10.46|-8.02|>0.05
91780427|NCT01532986|183440979|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED|95.0|0.0|0.34|||t-test, 2 sided|||||0.34|0.00|>0.05
91780428|NCT01532986|183440980|SUPERIORITY||Mean Difference (Final Values)|-0.06|||>|0.05|TWO_SIDED|95.0|-1.45|1.33|||t-test, 2 sided|||||1.33|-1.45|>0.05
91780429|NCT01532986|183440981|SUPERIORITY||Mean Difference (Final Values)|-11.52|||<|0.05|TWO_SIDED|95.0|-20.42|-2.62|||t-test, 2 sided|||||-2.62|-20.42|<0.05
91709033|NCT03035916|183311323|OTHER|||||||0.454|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.454
91780430|NCT01532986|183440982|SUPERIORITY||Mean Difference (Final Values)|-1.98|||>|0.05|TWO_SIDED|95.0|-4.2|0.24|||t-test, 2 sided|||||0.24|-4.20|>0.05
91780431|NCT03408392|183440983|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.38|||||TWO_SIDED|90.0|96.11|115.54||||||||115.54|96.11|
91780432|NCT03408392|183440984|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|101.14|||||TWO_SIDED|90.0|93.37|109.55||||||||109.55|93.37|
91780433|NCT03408392|183440985|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.14|||||TWO_SIDED|90.0|96.31|114.78||||||||114.78|96.31|
91780434|NCT00885170|183441014|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.67|||<|0.001|TWO_SIDED|95.0|1.17|4.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value \< 0.001).||4.17|1.17|<0.001
91780435|NCT00885170|183441015|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-5.5|||||TWO_SIDED|95.0|-16.9|6.0|||||Based on Miettinen \& Nurminen method.|||6.0|-16.9|
91780436|NCT00885170|183441016|SUPERIORITY_OR_OTHER||Difference in the Percentage vs. Placebo|5.7|||||TWO_SIDED|95.0|-0.4|12.6|||||Based on Miettinen \& Nurminen method.|||12.6|-0.4|
91780437|NCT00885170|183441017|SUPERIORITY_OR_OTHER||Difference in the least Squares Means|0.88||||0.166|TWO_SIDED|95.0|-0.37|2.14|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.14|-0.37|0.166
91780438|NCT00885170|183441018|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|3.18||||0.002|TWO_SIDED|95.0|1.19|5.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||5.17|1.19|0.002
91780439|NCT00885170|183441019|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.0||||0.142|TWO_SIDED|95.0|-0.34|2.35|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.35|-0.34|0.142
91780440|NCT00885170|183441020|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.7|||<|0.001|TWO_SIDED|95.0|1.41|4.0|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||4.00|1.41|<0.001
91780441|NCT00885170|183441021|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.06||||0.023|TWO_SIDED|95.0|0.15|1.98|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.98|0.15|0.023
91780442|NCT00885170|183441022|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.57|||<|0.001|TWO_SIDED|95.0|1.26|3.89|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||3.89|1.26|<0.001
91780443|NCT00885170|183441023|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.8||||0.103|TWO_SIDED|95.0|-0.16|1.77|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.77|-0.16|0.103
91780444|NCT00885170|183441024|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.22||||0.763|TWO_SIDED|95.0|-1.23|1.67|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.67|-1.23|0.763
91780445|NCT00885170|183441025|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.38||||0.578|TWO_SIDED|95.0|-0.96|1.72|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.72|-0.96|0.578
91780446|NCT00885170|183441026|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.16||||0.5|TWO_SIDED|95.0|-19.39|39.72|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||39.72|-19.39|0.500
91780447|NCT00885170|183441027|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.82||||0.709|TWO_SIDED|95.0|-36.29|24.65|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||24.65|-36.29|0.709
91780448|NCT00885170|183441028|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-47.04|||<|0.001|TWO_SIDED|95.0|-62.4|-31.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.67|-62.40|<0.001
91780449|NCT00885170|183441029|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.29|||<|0.001|TWO_SIDED|95.0|-61.43|-31.15|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.15|-61.43|<0.001
91587345|NCT01676909|183063993|SUPERIORITY|||||||0.727|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.727
91780450|NCT00885170|183441030|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.96||||0.186|TWO_SIDED|95.0|-5.29|27.22|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||27.22|-5.29|0.186
91780451|NCT00885170|183441031|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|12.82||||0.015|TWO_SIDED|95.0|2.54|23.1|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||23.10|2.54|0.015
91780452|NCT00885170|183441032|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|31.17||||0.011|TWO_SIDED|95.0|7.13|55.21|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||55.21|7.13|0.011
91587346|NCT01676909|183063994|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.446
91780453|NCT00885170|183441033|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|24.01||||0.059|TWO_SIDED|95.0|-0.93|48.94|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||48.94|-0.93|0.059
91780454|NCT00885170|183441034|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.11||||0.846|TWO_SIDED|95.0|-0.95|1.16|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||1.16|-0.95|0.846
91709034|NCT03035916|183311323|OTHER|||||||0.402|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.402
91709035|NCT03035916|183311323|OTHER|||||||0.901|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.901
91709036|NCT03035916|183311323|OTHER|||||||0.54|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.540
91709037|NCT03035916|183311323|OTHER|||||||0.523|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.523
91780455|NCT00885170|183441035|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.38||||0.413|TWO_SIDED|95.0|-1.91|4.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||4.67|-1.91|0.413
91780456|NCT00885170|183441036|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.91||||0.326|TWO_SIDED|95.0|-17.66|5.85|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||5.85|-17.66|0.326
91780457|NCT00885170|183441037|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.47||||0.835|TWO_SIDED|95.0|-12.37|15.32|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||15.32|-12.37|0.835
91780458|NCT00885170|183441038|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-3.13||||0.376|TWO_SIDED|95.0|-10.04|3.78|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||3.78|-10.04|0.376
91780459|NCT03771664|183441039|SUPERIORITY||Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.23||0.1537|TWO_SIDED|95.0|-1.2|7.7||Average change from baseline in SE was analyzed by analysis of covariance (ANCOVA) with explanatory (treatment, baseline antidepressant use, baseline SE) and response variables \[change from baseline in sleep efficiency at Day 14 (EODBT)\].|ANCOVA|||||7.7|-1.2|0.1537
91780460|NCT03771664|183441040|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|8.07||0.1126|TWO_SIDED|95.0|-29.0|3.1||Change from BL in overall WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from baseline (BL) in overall WASO||3.1|-29.0|0.1126
91709038|NCT03035916|183311323|OTHER|||||||0.26|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.260
91587347|NCT01676909|183063995|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.459
91780461|NCT03771664|183441040|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9819|TWO_SIDED|95.0|-3.3|3.2||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 1||3.2|-3.3|0.9819
91780462|NCT03771664|183441040|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|3.19||0.1838|TWO_SIDED|95.0|-10.6|2.1||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 2||2.1|-10.6|0.1838
91780463|NCT03771664|183441040|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.97||0.0797|TWO_SIDED|95.0|-15.0|0.9||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 3||0.9|-15.0|0.0797
91780464|NCT03771664|183441040|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|4.24||0.1559|TWO_SIDED|95.0|-14.5|2.4||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 4||2.4|-14.5|0.1559
91780465|NCT03771664|183441041|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|10.67||0.1441|TWO_SIDED|95.0|-5.5|37.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in overall TST||37.0|-5.5|0.1441
91780466|NCT03771664|183441041|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.47||0.3951|TWO_SIDED|95.0|-6.2|15.6||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 1||15.6|-6.2|0.3951
91780467|NCT03771664|183441041|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|4.16||0.3705|TWO_SIDED|95.0|-4.5|12.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BLPSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 2||12.0|-4.5|0.3705
91780468|NCT03771664|183441041|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|4.04||0.1412|TWO_SIDED|95.0|-2.0|14.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 3||14.0|-2.0|0.1412
91780469|NCT03771664|183441041|SUPERIORITY||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|4.24||0.1298|TWO_SIDED|95.0|-2.0|15.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 4||15.0|-2.0|0.1298
91780470|NCT03771664|183441042|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|7.87||0.7526|TWO_SIDED|95.0|-18.2|13.2||Change from BL in LPS was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||13.2|-18.2|0.7526
91780471|NCT03771664|183441043|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6769|TWO_SIDED|95.0|-2.0|1.3||Change from BL in NAW was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||1.3|-2.0|0.6769
91780472|NCT03771664|183441044|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.0824|TWO_SIDED|95.0|-6.4|0.4||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in mean duration of awakenings (MDA) in total||0.4|-6.4|0.0824
91780473|NCT03771664|183441044|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.4269|TWO_SIDED|95.0|-3.0|1.3||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 1||1.3|-3.0|0.4269
91780474|NCT03771664|183441044|SUPERIORITY|Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|3.02||0.2482|TWO_SIDED|95.0|-9.5|2.5|||ANCOVA|||Change from BL in MDA in quarter 2||2.5|-9.5|0.2482
91780475|NCT03771664|183441044|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|3.34||0.3076|TWO_SIDED|95.0|-10.1|3.2||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 3||3.2|-10.1|0.3076
91780476|NCT03771664|183441044|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.4491|TWO_SIDED|95.0|-1.9|0.8||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 4||0.8|-1.9|0.4491
91780477|NCT03771664|183441045|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|2.47||0.8724|TWO_SIDED|95.0|-4.5|5.3||Change from BL in DS N1 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in duration of stage (DS) N1 sleep||5.3|-4.5|0.8724
91780478|NCT03771664|183441045|SUPERIORITY||LS Mean Difference|18.6|STANDARD_ERROR_OF_MEAN|8.08||0.0238|TWO_SIDED|95.0|2.5|34.7||Change from BL in DS N2 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N2 sleep||34.7|2.5|0.0238
91780479|NCT03771664|183441045|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62||0.3863|TWO_SIDED|95.0|-6.3|16.1||Change from BL in DS N3 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N3 sleep||16.1|-6.3|0.3863
91780480|NCT03771664|183441045|SUPERIORITY||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.69||0.032|TWO_SIDED|95.0|-19.6|-0.9||Change from BL in REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14(EODBT)\].|ANCOVA|||Change from BL in duration of REM sleep||-0.9|-19.6|0.0320
91780481|NCT03771664|183441046|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9524|TWO_SIDED|95.0|-1.7|1.6||Change from BL in PS N1 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score;Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in percentage of stage (PS) N1 sleep time||1.6|-1.7|0.9524
91587348|NCT01676909|183063996|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
91780482|NCT03771664|183441046|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.55||0.093|TWO_SIDED|95.0|-0.5|5.7||Change from BL in PS N2 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N2 sleep time||5.7|-0.5|0.0930
91780483|NCT03771664|183441046|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.52||0.4427|TWO_SIDED|95.0|-1.9|4.2||Change from BL in PS N3 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N3 sleep time||4.2|-1.9|0.4427
91780484|NCT03771664|183441046|SUPERIORITY||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.06||0.0006|TWO_SIDED|95.0|-5.9|-1.7||Change from BL in % of REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in percentage (%) of REM sleep time||-1.7|-5.9|0.0006
91780485|NCT03771664|183441047|SUPERIORITY||LS Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|12.42||0.0083|TWO_SIDED|95.0|8.9|58.4||Change from BL in latency to first REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the first REM period||58.4|8.9|0.0083
91587349|NCT01676909|183063997|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.238
91780486|NCT03771664|183441047|SUPERIORITY||LS Mean Difference|43.2|STANDARD_ERROR_OF_MEAN|10.95||0.0002|TWO_SIDED|95.0|21.3|65.0||Change from BL in latency to second REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the second REM period||65.0|21.3|0.0002
91780487|NCT03771664|183441047|SUPERIORITY||LS Mean Difference|38.2|STANDARD_ERROR_OF_MEAN|10.99||0.0009|TWO_SIDED|95.0|16.2|60.2||Change from BL in latency to third REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the third REM period||60.2|16.2|0.0009
91780488|NCT03771664|183441047|SUPERIORITY||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|14.84||0.0899|TWO_SIDED|95.0|-4.3|56.3||Change from BL in latency to fourth REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the fourth REM period||56.3|-4.3|0.0899
91780489|NCT03771664|183441048|SUPERIORITY||LS Mean Difference|-171.1|STANDARD_ERROR_OF_MEAN|46.06||0.0004|TWO_SIDED|95.0|-262.9|-79.4||Change from BL in REM density was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-79.4|-262.9|0.0004
91780490|NCT03771664|183441049|SUPERIORITY||LS Mean Difference|-288.0|STANDARD_ERROR_OF_MEAN|68.81|<|0.0001|TWO_SIDED|95.0|-425.1|-151.0||Change from BL in REMA was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, baseline PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-151.0|-425.1|<0.0001
91780491|NCT03771664|183441051|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|14.65||0.4814|TWO_SIDED|95.0|-18.8|39.5||Change from BL in sTST was analyzed by Mixed Model Repeated Measures (MMRM) with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sTST||39.5|-18.8|0.4814
91780492|NCT03771664|183441051|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|6.45||0.0964|TWO_SIDED|95.0|-23.7|2.0||Change from BL in sWASO was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sWASO||2.0|-23.7|0.0964
91780493|NCT03771664|183441051|SUPERIORITY||LS Mean Difference|6.6|STANDARD_ERROR_OF_MEAN|7.32||0.3672|TWO_SIDED|95.0|-7.9|21.2||Change from BL in sSL was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sSL||21.2|-7.9|0.3672
91780494|NCT02120898|183441063|EQUIVALENCE|90% CI interval was -0.20 to +0.20 for therapeutic equivalence.|Percentage difference|-1.16||||0.0702|TWO_SIDED|90.0|-7.93|5.62|||Fisher Exact|||Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||5.62|-7.93|0.0702
91780495|NCT02120898|183441064|SUPERIORITY||Percentage difference|0.14||||0.0318|TWO_SIDED|90.0|-6.08|6.35||Threshold for significance at 0.05 level.|Fisher Exact|||Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||6.35|-6.08|0.0318
91780496|NCT00561925|183441068|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%|Cochran's statistic|4.9|||<|0.0001||95.0|-0.1|10.0|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.0|-0.1|<0.0001
91780497|NCT00561925|183441070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%|Cochran's statistic|4.84|||<|0.0001||95.0|-1.11|10.79|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.79|-1.11|<0.0001
91780498|NCT00561925|183441072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7719||95.0|-0.08|0.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||0.06|-0.08|0.7719
91780499|NCT00561925|183441073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.87||||0.0078||95.0|8.67|57.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||57.06|8.67|0.0078
91780500|NCT00561925|183441081|NON_INFERIORITY_OR_EQUIVALENCE|equivalence test with 80% -125% boundaries|adjusted gMean|79.58|STANDARD_ERROR_OF_MEAN|1.04||0.5542||90.0|74.62|84.86||p-value for ratio outside the interval 80%-125%|ANOVA||Inter-individual gCV = 49.9|adjusted geometric mean ratio NVP XR : NVP IR||84.86|74.62|0.5542
91780501|NCT00684021|183441085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.959|TWO_SIDED|95.0|-4.1|3.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||3.9|-4.1|0.959
91780502|NCT00684021|183441086|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.93|TWO_SIDED|95.0|0.42|2.23|||Fisher Exact|||Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.||2.23|0.42|0.93
91780503|NCT00684021|183441087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|4.8||0.585|TWO_SIDED|95.0|-12.2|6.9|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||6.9|-12.2|0.585
91780504|NCT00684021|183441088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|3.7||0.831|TWO_SIDED|95.0|-6.6|8.2|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||8.2|-6.6|0.831
91780505|NCT00684021|183441089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.817|TWO_SIDED|95.0|-5.5|7.0|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||7.0|-5.5|0.817
91780506|NCT00684021|183441090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|4.27||0.272|TWO_SIDED|95.0|-13.7|3.67|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||3.67|-13.7|0.272
91780507|NCT00684021|183441091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.409|TWO_SIDED|95.0|-3.0|1.2|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||1.2|-3.0|0.409
91780508|NCT00684021|183441091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|100.0|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|15.0|1000.0|||Regression, Linear|||||1000|15|0.02
91780509|NCT00684021|183441092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.777|TWO_SIDED|95.0|-3.9|2.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||2.9|-3.9|0.777
91780510|NCT00926237|183441176|SUPERIORITY||Mean Difference (Final Values)|-5.74||||0.04|ONE_SIDED|||||t value = -1.40|Mixed Models Analysis||1Hz active rTMS - Sham rTMS|||||.04
91780511|NCT00926237|183441176|SUPERIORITY||Mean Difference (Final Values)|-6.77||||0.02|ONE_SIDED|||||t value = -2.03|Mixed Models Analysis||10 Hz active rTMS - Sham rTMS|||||.02
91780512|NCT00926237|183441176|SUPERIORITY||Mean Difference (Final Values)|-4.73||||0.2|ONE_SIDED|||||t value = -1..28|Mixed Models Analysis||10 Hz washout - sham washout period|||||.20
91780513|NCT00926237|183441176|SUPERIORITY||Mean Difference (Final Values)|-5.19||||0.19|ONE_SIDED|||||t value = -1.29|Mixed Models Analysis||1Hz washout - sham washout|||||.19
91780514|NCT01732718|183441209|SUPERIORITY|||||||0.51|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.51
91780515|NCT01732718|183441210|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91780516|NCT01732718|183441212|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91780517|NCT01732718|183441214|SUPERIORITY|||||||0.57|||||||see comments for explanation|albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)||||||0.57
91780518|NCT01732718|183441218|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91780519|NCT01732718|183441219|SUPERIORITY|||||||0.1469|||||||t-test, 1 sided|||Comparison of the change in AMC||||0.1469
91780520|NCT01732718|183441219|SUPERIORITY|||||||0.2382|||||||t-test, 1 sided|||Comparison of the change in ALC||||0.2382
91780521|NCT01732718|183441219|SUPERIORITY|||||||0.5833|||||||t-test, 1 sided|||Comparison of the change in ANC||||0.5833
91587350|NCT01676909|183063998|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.011
91587351|NCT01676909|183063999|SUPERIORITY|||||||0.709|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.709
91709039|NCT03035916|183311323|OTHER|||||||0.139|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.139
91780522|NCT01732718|183441222|SUPERIORITY|||||||0.5184|||||||Wilcoxon (Mann-Whitney)|||||||0.5184
91780523|NCT04050202|183441224|OTHER||Mean Difference (Net)|8.45|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score.|||||<0.01
91780524|NCT04050202|183441225|OTHER||Mean Difference (Net)|13.97|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score|||||<0.01
91780525|NCT01411891|183441243|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.3|8.4||||||||8.4|0.3|
91780526|NCT01411891|183441244|SUPERIORITY||Risk Ratio (RR)|0.8||||0.65|TWO_SIDED|95.0|0.4|1.6|||Regression, Logistic|||||1.6|0.4|0.65
91780527|NCT01075685|183441245|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Type 3 tests of fixed effects|||||||0.0279
91780528|NCT01075685|183441246|SUPERIORITY_OR_OTHER|||||||0.0189||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0189
91780529|NCT01075685|183441247|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Chi-squared|||||||0.009
91780530|NCT01075685|183441248|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Chi-squared|||||||0.082
91780531|NCT00643162|183441299|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|6.15||0.68|TWO_SIDED||||||t-test, 2 sided|||||||.68
91780532|NCT00847210|183441319|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||There was no statistical significant difference (p-value \>0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.|ANOVA|||This study was not powered for any hypothesis testing. For Tmax, an analysis of variance (ANOVA) model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||||0.095
91780533|NCT00847210|183441320|SUPERIORITY_OR_OTHER||ratio of the central values for Cmax|1.21||||0.289|TWO_SIDED|90.0|0.897|1.63|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For natural logarithm of dose-normalized Cmax, an ANOVA model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. Site effect was tested in the model, and was not included in the final model if not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.630|0.897|0.289
91780534|NCT00847210|183441321|SUPERIORITY_OR_OTHER||Ratio of the dose-normalized AUC(0-tlqc)|1.158||||0.402|TWO_SIDED|90.0|0.864|1.551|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.551|0.864|0.402
91780535|NCT00847210|183441322|SUPERIORITY_OR_OTHER||Ratio of the central values for dose-nor|1.168||||0.388|TWO_SIDED|90.0|0.864|1.579|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.579|0.864|0.388
91780536|NCT01656408|183441342|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|3.8||0.978|TWO_SIDED|90.0|-6.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||6.6|-6.4|0.978
91780537|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|3.2||0.005|TWO_SIDED|90.0|-15.4|-4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.5|-15.4|0.005
91780538|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|3.3||0|TWO_SIDED|90.0|-19.8|-8.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-8.4|-19.8|0.000
91587352|NCT01676909|183064000|SUPERIORITY|||||||0.134|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.134
91587353|NCT01676909|183064001|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.045
91587354|NCT01676909|183064002|SUPERIORITY|||||||0.099|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.099
91587355|NCT01676909|183064003|SUPERIORITY|||||||0.852|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.852
91587356|NCT01676909|183064004|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.285
91587357|NCT01676909|183064005|SUPERIORITY|||||||0.222|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.222
91587358|NCT00823901|183064026|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
91587359|NCT01369511|183064027|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.527
91587360|NCT01369511|183064027|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.291
91780539|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|3.2||0.03|TWO_SIDED|90.0|-13.0|-1.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-1.9|-13.0|0.030
91780540|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|4.9||0.484|TWO_SIDED|90.0|-4.9|11.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||11.9|-4.9|0.484
91780541|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.0||0.169|TWO_SIDED|90.0|-9.3|0.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||0.9|-9.3|0.169
91780542|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|3.6||0.023|TWO_SIDED|90.0|-14.9|-2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-2.6|-14.9|0.023
91780543|NCT01656408|183441342|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.6||0.605|TWO_SIDED|90.0|-10.4|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||5.5|-10.4|0.605
91587361|NCT01369511|183064027|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.129
91780544|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.9||0.635|TWO_SIDED|90.0|-4.9|8.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||8.7|-4.9|0.635
91780545|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.8||0.077|TWO_SIDED|90.0|-10.1|-0.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.4|-10.1|0.077
91780546|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|90.0|-15.0|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.7|-15.0|0.001
91780547|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.5||0.556|TWO_SIDED|90.0|-8.0|3.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.9|-8.0|0.556
91780548|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.3||0.527|TWO_SIDED|90.0|-5.5|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||2.5|-5.5|0.527
91780549|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.8||0.234|TWO_SIDED|90.0|-8.1|1.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||1.4|-8.1|0.234
91587362|NCT01369511|183064028|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.751
91780550|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|90.0|-12.7|-4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-4.1|-12.7|0.002
91780551|NCT01656408|183441343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.1||0.726|TWO_SIDED|90.0|-4.2|6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.5|-4.2|0.726
91587363|NCT01369511|183064028|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.066
91587364|NCT01369511|183064028|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.031
91521236|NCT02954354|182917044|SUPERIORITY|||||||0.8033||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||96 hours||||0.8033
91587365|NCT01369511|183064028|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.315
91587366|NCT01369511|183064028|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.002
91780552|NCT01656408|183441344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.5||0.855|TWO_SIDED|90.0|-9.0|7.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||7.3|-9.0|0.855
91780553|NCT01656408|183441344|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.1||0.658|TWO_SIDED|90.0|-10.8|18.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||18.1|-10.8|0.658
91780554|NCT01656408|183441344|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|7.1||0.392|TWO_SIDED|90.0|-6.3|18.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||18.9|-6.3|0.392
91587367|NCT01369511|183064028|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.007
91587368|NCT01376349|183064029|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91587369|NCT01376349|183064029|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91587370|NCT05193500|183064039|OTHER|||||||0.085||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|one-sample t-test, compared to 0.5 (chance)||||||0.085
91587371|NCT05193500|183064039|OTHER|||||||0.049||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.049
91587372|NCT05193500|183064040|OTHER|||||||0.015||||||a priori threshold for statistical significance = 0.05|t-test, 2 sided|||||||0.015
91587373|NCT01294683|183064068|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.654|TWO_SIDED|95.0|-1.434|0.936|||Miettinen and Nurminen|||Periods I/II||0.936|-1.434|0.654
91780555|NCT01656408|183441345|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.5||0.563|TWO_SIDED|90.0|-6.0|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-6.0|0.563
91780556|NCT01656408|183441345|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9||0.381|TWO_SIDED|90.0|-0.8|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||2.5|-0.8|0.381
91780557|NCT01656408|183441345|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.0||0.387|TWO_SIDED|90.0|-1.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||5.2|-1.7|0.387
91587374|NCT01294683|183064068|SUPERIORITY_OR_OTHER||Difference in Percentages|1.304||||0.09|TWO_SIDED|95.0|-0.427|3.768|||Miettinen and Nurminen|||Period III||3.768|-0.427|0.090
91587375|NCT01294683|183064069|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.563|TWO_SIDED|95.0|-1.303|0.779|||Miettinen and Nurminen|||Periods I/II||0.779|-1.303|0.563
91587376|NCT01294683|183064069|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
91587377|NCT01294683|183064071|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
91587378|NCT01294683|183064074|SUPERIORITY_OR_OTHER||Difference in Percentages|0.617||||0.255|TWO_SIDED|95.0|-0.575|2.023|||Miettinen and Nurminen|||Periods I/II||2.023|-0.575|0.255
91587379|NCT01294683|183064074|SUPERIORITY_OR_OTHER||Difference in Percentages|0.395||||0.69|TWO_SIDED|95.0|-2.091|2.966|||Miettinen and Nurminen|||Period III||2.966|-2.091|0.690
91647609|NCT02020785|183187181|SUPERIORITY|Main analyses were intention-to-treat using mixed effects models allowing intercepts to vary for each individual. Carryover effects were examined by using treatment by assignment-order interaction terms. Pre-specified sensitivity analyses were conducted excluding patients who were non-compliant, prior to data analysis: 1st, noncompliance based on missing product pickups and follow-up visits; 2nd, suspected poor compliance (\< 250 mg difference between the higher and lower period).\]|Mean Difference (Final Values)|0.143||||0.05|TWO_SIDED|95.0|-0.025|0.34||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (14.3%, 95% CI: -2.5%, 34.0%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed 24-hour urine albumin excretion|Sample size for this study was calculated using the xsampsi module in STATA, based on a previous study with repeat 24-hour urine collections (standard deviation, 1.04). At an α level of 0.05, we anticipated that a sample size of 30 participants with mean albuminuria of 100 mg/d would result in \>80% power to detect a 13% difference in log- transformed albuminuria between the higher and lower phosphorus additive periods.||0.34|-0.025|0.05
91647610|NCT02020785|183187182|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.05|TWO_SIDED|95.0|-0.059|0.136||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (3.4%, 95% CI: -5.9%, 13.6%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed fibroblast growth factor 23|||0.136|-0.059|0.05
91647611|NCT02020785|183187183|SUPERIORITY||mean difference (during each period)|-1.1||||0.05|TWO_SIDED|95.0|-4.1|1.9||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.9|-4.1|0.05
91780558|NCT01656408|183441346|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|4.7||0.357|TWO_SIDED|90.0|-3.9|12.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||12.8|-3.9|0.357
91780559|NCT01656408|183441346|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|4.8||0.15|TWO_SIDED|90.0|-1.2|15.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||15.9|-1.2|0.150
91780560|NCT01656408|183441346|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|5.2||0.578|TWO_SIDED|90.0|-6.3|12.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||12.3|-6.3|0.578
91780561|NCT01656408|183441347|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.0||0.942|TWO_SIDED|90.0|-5.1|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||5.5|-5.1|0.942
91780562|NCT01656408|183441347|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.7||0.627|TWO_SIDED|90.0|-4.8|8.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||8.5|-4.8|0.627
91780563|NCT01656408|183441347|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|1.9||0.046|TWO_SIDED|90.0|0.9|7.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.6|0.9|0.046
91780564|NCT01656408|183441348|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|3.8||0.025|TWO_SIDED|90.0|-18.0|-3.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.6|-18.0|0.025
91780565|NCT01656408|183441348|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.6||0.055|TWO_SIDED|90.0|-11.0|-1.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-1.1|-11.0|0.055
91780566|NCT01656408|183441349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.6||0.999|TWO_SIDED|90.0|-4.4|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.4|-4.4|0.999
91780567|NCT01656408|183441349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.2||0.934|TWO_SIDED|90.0|-5.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||5.2|-5.7|0.934
91780568|NCT01656408|183441349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.4||0.547|TWO_SIDED|90.0|-3.7|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.9|-3.7|0.547
91780569|NCT01656408|183441349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|2.9||0.906|TWO_SIDED|90.0|-5.2|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.5|-5.2|0.906
91780570|NCT01656408|183441349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.1||0.682|TWO_SIDED|90.0|-4.0|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||6.6|-4.0|0.682
91780571|NCT01656408|183441350|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|2.8||0.099|TWO_SIDED|90.0|-11.1|0.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||0.0|-11.1|0.099
91780572|NCT01656408|183441350|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.1||0.034|TWO_SIDED|90.0|-10.1|-1.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.7|-10.1|0.034
91780573|NCT01656408|183441351|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.0||0.281|TWO_SIDED|90.0|-6.5|1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||1.6|-6.5|0.281
91780574|NCT01656408|183441351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.333|TWO_SIDED|90.0|-1.2|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||4.0|-1.2|0.333
91587380|NCT01294683|183064075|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-0.967|0.967|||Miettinen and Nurminen|||Periods I/II||0.967|-0.967|>0.999
91587381|NCT01294683|183064076|SUPERIORITY_OR_OTHER||Difference in Percentages|-1.029|||||TWO_SIDED|95.0|-7.301|5.252|||Miettinen and Nurminen||Miettinen and Nurminen Method|Periods I/II||5.252|-7.301|
91587382|NCT01294683|183064076|SUPERIORITY_OR_OTHER||Difference in Percentages|0.889|||||TWO_SIDED|95.0|-7.599|9.338|||||Miettinen and Nurminen Method|Period III||9.338|-7.599|
91587383|NCT01294683|183064077|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.412|||||TWO_SIDED|95.0|-4.28|3.45||||||Periods I/II||3.450|-4.280|
91587384|NCT01294683|183064077|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.533|||||TWO_SIDED|95.0|-3.916|2.619|||||Miettinen and Nurminen Method|Period III||2.619|-3.916|
91587385|NCT01794923|183064078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||Analysis was performed using an analysis of variance (ANOVA) model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||||0.200
91587386|NCT01794923|183064078|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|7.6||||0.23|TWO_SIDED|95.0|-4.81|19.92|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||19.92|-4.81|0.230
91587387|NCT01794923|183064078|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4||||0.484|TWO_SIDED|95.0|-16.81|7.99|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||7.99|-16.81|0.484
91647612|NCT02020785|183187184|SUPERIORITY||mean difference (during each period)|-0.8||||0.05|TWO_SIDED|95.0|-2.7|1.0||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.0|-2.7|0.05
91587388|NCT01794923|183064078|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.0||||0.077|TWO_SIDED|95.0|-1.32|25.25|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||25.25|-1.32|0.077
91587389|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.860
91587390|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.0||||0.584|TWO_SIDED|95.0|-18.3|32.38|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||32.38|-18.30|0.584
91587391|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6||||0.838|TWO_SIDED|95.0|-22.77|28.06|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.06|-22.77|0.838
91587392|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.4||||0.75|TWO_SIDED|95.0|-22.81|31.61|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||31.61|-22.81|0.750
91587393|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.533
91780575|NCT01656408|183441352|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.4||0.279|TWO_SIDED|90.0|-9.7|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.1|-9.7|0.279
91780576|NCT01656408|183441352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.4||0.817|TWO_SIDED|90.0|-6.9|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||5.2|-6.9|0.817
91780577|NCT01656408|183441353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.756|TWO_SIDED|90.0|-3.2|4.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.7|-3.2|0.756
91780578|NCT01656408|183441353|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|2.8||0.158|TWO_SIDED|90.0|-0.7|8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.6|-0.7|0.158
91587394|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-13.9||||0.326|TWO_SIDED|95.0|-41.81|13.95|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||13.95|-41.81|0.326
91587395|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0||||0.945|TWO_SIDED|95.0|-26.98|28.94|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.94|-26.98|0.945
91587396|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.9||||0.327|TWO_SIDED|95.0|-44.85|15.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||15.03|-44.85|0.327
91587397|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.988
91587398|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.2||||0.887|TWO_SIDED|95.0|-48.31|41.81|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||41.81|-48.31|0.887
91587399|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.7||||0.907|TWO_SIDED|95.0|-47.88|42.5|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||42.50|-47.88|0.907
91587400|NCT01794923|183064079|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.982|TWO_SIDED|95.0|-48.95|47.83|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||47.83|-48.95|0.982
91647613|NCT02164539|183187185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
91647614|NCT02164539|183187185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
91647615|NCT02164539|183187185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
91647616|NCT02164539|183187185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
91780579|NCT01656408|183441353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.8||0.404|TWO_SIDED|90.0|-2.4|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-2.4|0.404
91780580|NCT01656408|183441353|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.4||0.214|TWO_SIDED|90.0|-1.0|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||7.1|-1.0|0.214
91780581|NCT01656408|183441353|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.9||0.086|TWO_SIDED|90.0|0.2|10.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||10.0|0.2|0.086
91780582|NCT01656408|183441354|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|90.0|-16.8|-5.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.9|-16.8|0.003
91587401|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.630
91587402|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.342|TWO_SIDED|95.0|-0.39|0.14|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-0.39|0.342
91587403|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.6|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.34|0.600
91647617|NCT02164539|183187185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172|||Final dose response model|||||0.172|-0.027|0.152
91647618|NCT02164539|183187186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.01|TWO_SIDED|95.0|-1.7|-0.2|||ANCOVA|||||-0.2|-1.7|0.010
91587404|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.691|TWO_SIDED|95.0|-0.34|0.23|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.34|0.691
91780583|NCT01656408|183441354|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|3.5||0.105|TWO_SIDED|90.0|-12.3|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.1|-12.3|0.105
91780584|NCT01656408|183441355|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.691|TWO_SIDED|90.0|-7.5|4.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.6|-7.5|0.691
91780585|NCT01656408|183441355|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.9||0.57|TWO_SIDED|90.0|-4.3|8.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.8|-4.3|0.570
91780586|NCT01656408|183441355|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|3.4||0.666|TWO_SIDED|90.0|-4.2|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-4.2|0.666
91780587|NCT01656408|183441355|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|4.7||0.534|TWO_SIDED|90.0|-10.9|4.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.9|-10.9|0.534
91587405|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.091
91587406|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.351|TWO_SIDED|95.0|-0.44|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.16|-0.44|0.351
91587407|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.029|TWO_SIDED|95.0|-0.64|-0.04|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||-0.04|-0.64|0.029
91647619|NCT02164539|183187186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.004|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.4|-1.9|0.004
91647620|NCT02164539|183187186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.083|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||0.1|-1.4|0.083
91647621|NCT02164539|183187186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.014|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.2|-1.5|0.014
91647622|NCT02164539|183187186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.031|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.1|-1.4|0.031
91647623|NCT02164539|183187187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.7|||ANCOVA|||||-1.7|-4.6|<0.001
91647624|NCT02164539|183187187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<0.001
91647625|NCT02164539|183187187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.007|TWO_SIDED|95.0|-3.4|-0.6|||ANCOVA|||||-0.6|-3.4|0.007
91647626|NCT02164539|183187187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.002|TWO_SIDED|95.0|-3.2|-0.7|||ANCOVA|||||-0.7|-3.2|0.002
91780588|NCT01656408|183441355|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|4.0||0.528|TWO_SIDED|90.0|-4.1|9.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||9.2|-4.1|0.528
91780589|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.0||0.848|TWO_SIDED|90.0|-3.8|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-3.8|0.848
91780590|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-8.0|-4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.0|-8.0|<0.0001
91780591|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.5||0.025|TWO_SIDED|90.0|-14.4|-2.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.4|-14.4|0.025
91780592|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.8||0.044|TWO_SIDED|90.0|-7.0|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.8|-7.0|0.044
91780593|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.0||0.139|TWO_SIDED|90.0|-0.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.6|-0.4|0.139
91780594|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5||0.088|TWO_SIDED|90.0|-8.9|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-0.2|-8.9|0.088
91647627|NCT02164539|183187187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.009|TWO_SIDED|95.0|-2.9|-0.4|||ANCOVA|||||-0.4|-2.9|0.009
91647628|NCT02164539|183187188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1||||0.004||95.0|5.9|30.3|||ANCOVA|||||30.3|5.9|0.004
91647629|NCT02164539|183187188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.8|||<|0.001|TWO_SIDED|95.0|9.4|34.1|||ANCOVA|||||34.1|9.4|<0.001
91647630|NCT02164539|183187188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7||||0.001|TWO_SIDED|95.0|7.7|31.7|||ANCOVA|||||31.7|7.7|0.001
91647631|NCT02164539|183187188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.8|||<|0.001|TWO_SIDED|95.0|14.1|35.4|||ANCOVA|||||35.4|14.1|<0.001
91647632|NCT02164539|183187188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.5|||<|0.001|TWO_SIDED|95.0|8.0|29.1|||ANCOVA|||||29.1|8.0|<0.001
91647633|NCT02164539|183187189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.264|TWO_SIDED|95.0|-0.034|0.125|||ANCOVA|||||0.125|-0.034|0.264
91647634|NCT02164539|183187189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.328|TWO_SIDED|95.0|-0.041|0.121|||ANCOVA|||||0.121|-0.041|0.328
91647635|NCT02164539|183187189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.534|TWO_SIDED|95.0|-0.054|0.103|||ANCOVA|||||0.103|-0.054|0.534
91647636|NCT02164539|183187189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.005||||0.895|TWO_SIDED|95.0|-0.065|0.075|||ANCOVA|||||0.075|-0.065|0.895
91647637|NCT02164539|183187189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076||||0.031|TWO_SIDED|95.0|0.007|0.146|||ANCOVA|||||0.146|0.007|0.031
91647638|NCT02164539|183187190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.019|TWO_SIDED|95.0|-0.162|-0.014|||ANCOVA|||||-0.014|-0.162|0.019
91647639|NCT02164539|183187190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.091||||0.017|TWO_SIDED|95.0|-0.165|-0.016|||ANCOVA|||||-0.016|-0.165|0.017
91647640|NCT02164539|183187190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.017|TWO_SIDED|95.0|-0.162|-0.016|||ANCOVA|||||-0.016|-0.162|0.017
91647641|NCT02164539|183187190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.066|TWO_SIDED|95.0|-0.124|0.004|||ANCOVA|||||0.004|-0.124|0.066
91647642|NCT02164539|183187190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.227|-0.099|||ANCOVA|||||-0.099|-0.227|<0.001
91647643|NCT01255722|183187191|NON_INFERIORITY_OR_EQUIVALENCE|The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).|Mean Difference (Final Values)|-0.033||||0.05|TWO_SIDED|95.0|-0.088|0.021|||Chi-squared|||Iobitridol was compared to the best of the two comparators. The two-sided 95% confidence interval (CI) of the difference between both proportions (Iobitridol - Comparator) was computed and the lower limit of the CI compared to the clinical non-inferiority limit in the study. The non-inferiority of iobitridol over the best comparator was established if the lower limit of the two-sided 95% CI was equal to or higher than the clinical non-inferiority limit.||0.021|-0.088|0.05
91647644|NCT01255722|183187192|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.750
91647645|NCT01255722|183187194|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
91780595|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|2.2||0.023|TWO_SIDED|90.0|-9.3|-1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.6|-9.3|0.023
91647646|NCT01255722|183187195|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||Fisher Exact|||||||0.109
91647647|NCT01255722|183187196|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Fisher Exact|||||||0.09
91647648|NCT00701935|183187197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|4.432||0.8252|TWO_SIDED|95.0|-9.92|7.95||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.||"The power calculation is based on a two-sided t-test and significance level of 0.05.~Hypotheses for sample size:~Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%~94 patients are needed to attain the 37 patients randomized and analyzed in each group."||7.95|-9.92|0.8252
91647649|NCT00701935|183187198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|3.193||0.5207|TWO_SIDED|95.0|-8.53|4.39||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.||||4.39|-8.53|0.5207
91647650|NCT00701935|183187199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|2.687||0.1755|TWO_SIDED|95.0|-9.15|1.73||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.||||1.73|-9.15|0.1755
91647651|NCT00701935|183187200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001|TWO_SIDED|95.0|-1.19|-0.57||p-values were not adjusted for multiple comparisons.|ANCOVA|ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c||||-0.57|-1.19|<0.0001
91647652|NCT00701935|183187202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|0.491||0.0073|TWO_SIDED|95.0|-2.38|-0.4||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.||||-0.40|-2.38|0.0073
91647653|NCT00701935|183187203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.725||0.0035|TWO_SIDED|95.0|-3.66|-0.76||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.||||-0.76|-3.66|0.0035
91647654|NCT00701935|183187206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.248||0.4145|TWO_SIDED|95.0|-0.71|0.3||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol||||0.30|-0.71|0.4145
91647655|NCT00701935|183187207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.279||0.4007|TWO_SIDED|95.0|-0.8|0.33||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides||||0.33|-0.80|0.4007
91780596|NCT01656408|183441380|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.878|TWO_SIDED|90.0|-4.5|3.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||3.8|-4.5|0.878
91780597|NCT01656408|183441381|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.2||0.512|TWO_SIDED|90.0|-3.4|7.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.7|-3.4|0.512
91647656|NCT00701935|183187208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.7915|TWO_SIDED|95.0|-0.08|0.11||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol||||0.11|-0.08|0.7915
91780598|NCT01656408|183441381|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|3.0||0.429|TWO_SIDED|90.0|-7.5|2.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.7|-7.5|0.429
91780599|NCT01656408|183441381|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|2.9||0.166|TWO_SIDED|90.0|-9.3|0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.8|-9.3|0.166
91780600|NCT01656408|183441381|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.8||0.591|TWO_SIDED|90.0|-8.6|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.5|-8.6|0.591
91780601|NCT01656408|183441382|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|4.7||0.248|TWO_SIDED|90.0|-2.5|13.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.5|-2.5|0.248
91780602|NCT01656408|183441382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.836|TWO_SIDED|90.0|-5.6|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.4|-5.6|0.836
91780603|NCT01656408|183441382|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2||0.109|TWO_SIDED|90.0|-10.7|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.1|-10.7|0.109
91780604|NCT01656408|183441382|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|3.7||0.785|TWO_SIDED|90.0|-5.4|7.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.5|-5.4|0.785
91780605|NCT01656408|183441383|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.2||0.365|TWO_SIDED|90.0|-2.5|8.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.3|-2.5|0.365
91780606|NCT01656408|183441383|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.9||0.424|TWO_SIDED|90.0|-7.4|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.6|-7.4|0.424
91780607|NCT01656408|183441383|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|3.2||0.025|TWO_SIDED|90.0|-13.3|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.2|-13.3|0.025
91780608|NCT01656408|183441383|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|3.1||0.475|TWO_SIDED|90.0|-7.5|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.0|-7.5|0.475
91780609|NCT01656408|183441384|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.4||0.715|TWO_SIDED|90.0|-7.4|4.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.8|-7.4|0.715
91780610|NCT01656408|183441384|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|4.3||0.338|TWO_SIDED|90.0|-11.9|3.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||3.4|-11.9|0.338
91780611|NCT01656408|183441384|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.4||0.281|TWO_SIDED|90.0|-10.0|2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||2.3|-10.0|0.281
91780612|NCT01656408|183441385|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.8||0.317|TWO_SIDED|90.0|-2.1|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.9|-2.1|0.317
91780613|NCT01656408|183441386|SUPERIORITY_OR_OTHER||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|3.6||0.09|TWO_SIDED|90.0|0.2|13.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.2|0.2|0.090
91780614|NCT01656408|183441387|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.0||0.128|TWO_SIDED|90.0|-0.3|6.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.8|-0.3|0.128
91780615|NCT01656408|183441388|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.1||0.477|TWO_SIDED|90.0|-7.9|3.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.3|-7.9|0.477
91780616|NCT01656408|183441388|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.0||0.09|TWO_SIDED|90.0|-11.0|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||-0.2|-11.0|0.090
91780617|NCT01656408|183441388|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.0||0.028|TWO_SIDED|90.0|-13.0|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||-2.2|-13.0|0.028
91780618|NCT01656408|183441389|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.5||0.877|TWO_SIDED|90.0|-4.9|4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.1|-4.9|0.877
91780619|NCT01656408|183441390|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|4.6||0.827|TWO_SIDED|90.0|-9.3|7.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.2|-9.3|0.827
91780620|NCT01656408|183441391|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|3.5||0.161|TWO_SIDED|90.0|-11.4|1.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.0|-11.4|0.161
91780621|NCT01656408|183441392|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|4.4||0.046|TWO_SIDED|90.0|-18.8|-2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.3|-18.8|0.046
91780622|NCT01656408|183441392|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.3||0.001|TWO_SIDED|90.0|-17.2|-8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-8.6|-17.2|0.001
91780623|NCT01656408|183441393|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.6||0.91|TWO_SIDED|90.0|-4.6|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.2|-4.6|0.910
91780624|NCT01656408|183441394|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.6||0.906|TWO_SIDED|90.0|-6.6|5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.7|-6.6|0.906
91780625|NCT01656408|183441395|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.87|TWO_SIDED|90.0|-4.4|3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.7|-4.4|0.870
91780626|NCT01656408|183441396|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|90.0|-5.0|-3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.7|-5.0|<0.0001
91780627|NCT01656408|183441396|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|1.2||0.001|TWO_SIDED|90.0|-10.7|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-5.7|-10.7|0.001
91780628|NCT01656408|183441397|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.038|TWO_SIDED|90.0|-4.9|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.8|-4.9|0.038
91780629|NCT01656408|183441398|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.238|TWO_SIDED|90.0|-6.0|1.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.2|-6.0|0.238
91780630|NCT01656408|183441399|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.048|TWO_SIDED|90.0|-4.7|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.6|-4.7|0.048
91780631|NCT01656408|183441400|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.83|TWO_SIDED|90.0|-3.2|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.5|-3.2|0.830
91587408|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.238|TWO_SIDED|95.0|-0.13|0.52|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-0.13|0.238
91780632|NCT01656408|183441400|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.9||0.063|TWO_SIDED|90.0|-10.8|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-0.7|-10.8|0.063
91587409|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.305
91587410|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.37|TWO_SIDED|95.0|-0.54|0.2|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.20|-0.54|0.370
91587411|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.13|TWO_SIDED|95.0|-0.66|0.09|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.09|-0.66|0.130
91587412|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.28|0.51|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.51|-0.28|0.561
91780633|NCT01656408|183441401|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|3.7||0.892|TWO_SIDED|90.0|-7.1|6.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.1|-7.1|0.892
91780634|NCT01656408|183441402|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|3.1||0.571|TWO_SIDED|90.0|-3.4|6.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.9|-3.4|0.571
91780635|NCT01656408|183441403|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.8||0.816|TWO_SIDED|90.0|-5.4|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.0|-5.4|0.816
91780636|NCT01656408|183441404|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.2||0.061|TWO_SIDED|90.0|-8.4|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.6|-8.4|0.061
91780637|NCT01656408|183441404|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|2.6||0.161|TWO_SIDED|90.0|-8.3|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.7|-8.3|0.161
91780638|NCT01656408|183441405|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.0||0.786|TWO_SIDED|90.0|-4.0|2.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.9|-4.0|0.786
91780639|NCT01656408|183441406|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.3||0.263|TWO_SIDED|90.0|-9.3|1.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.8|-9.3|0.263
91587413|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.209|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.209
91587414|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.277|TWO_SIDED|95.0|-0.68|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.68|0.277
91647657|NCT00701935|183187209|SUPERIORITY_OR_OTHER||Ratio|3.28|STANDARD_ERROR_OF_MEAN|2.63||0.1388|TWO_SIDED|95.0|0.68|15.77||p-values were not adjusted for multiple comparisons.|Regression, Linear|Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.||Event rate per subject year was calculated for each subject : (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date.||15.77|0.68|0.1388
91780640|NCT01656408|183441407|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.0||0.565|TWO_SIDED|90.0|-4.4|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.1|-4.4|0.565
91780641|NCT00363480|183441408|SUPERIORITY_OR_OTHER||Percentage diffrence|-30.6|||<|0.0001|TWO_SIDED|95.0|-37.89|-23.29|||McNemar|||Comparison between GOAL and ACT response||-23.29|-37.89|<0.0001
91780642|NCT00363480|183441409|SUPERIORITY_OR_OTHER||t-Distribution|50.2|||||TWO_SIDED|95.0|43.15|57.32||||||||57.32|43.15|
91780643|NCT05465317|183441425|OTHER||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.65|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.65|<0.001
91587415|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.085|TWO_SIDED|95.0|-0.82|0.05|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.05|-0.82|0.085
91587416|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.546|TWO_SIDED|95.0|-0.32|0.61|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-0.32|0.546
91647658|NCT00947518|183187219|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.99
91780644|NCT05465317|183441425|OTHER||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.52|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.52|0.001
91780645|NCT05465317|183441425|OTHER||Hazard Ratio (HR)|0.79||||0.008|TWO_SIDED|95.0|0.67|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.67|0.008
91780646|NCT05465317|183441426|OTHER||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.60|0.005
91780647|NCT05465317|183441426|OTHER||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.41|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.41|0.02
91780648|NCT05465317|183441426|OTHER||Hazard Ratio (HR)|0.8||||0.08|TWO_SIDED|95.0|0.63|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.63|0.08
91780649|NCT05465317|183441427|OTHER||Hazard Ratio (HR)|0.68||||0.05|TWO_SIDED|95.0|0.46|1.0|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.00|0.46|0.05
91780650|NCT05465317|183441427|OTHER||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.35|1.09|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.09|0.35|0.09
91587417|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.185
91587418|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.4|TWO_SIDED|95.0|-0.64|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.26|-0.64|0.400
91587419|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.067|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.03|-0.88|0.067
91647659|NCT00947518|183187220|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
91647660|NCT00947518|183187221|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91647661|NCT00947518|183187222|SUPERIORITY||||||<|0.05|||||||Chi-squared||||For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni's correction was used.|||<0.05
91780651|NCT05465317|183441427|OTHER||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.29|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.29|0.43|0.30
91647662|NCT02065791|183187223|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.59|0.82|||Cox Proportional Hazard|||Comparison for canagliflozin versus placebo is reported here.||0.82|0.59|< 0.0001
91780652|NCT05465317|183441428|OTHER||Hazard Ratio (HR)|0.73||||0.11|TWO_SIDED|95.0|0.49|1.08|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.08|0.49|0.11
91780653|NCT05465317|183441428|OTHER||Hazard Ratio (HR)|0.63||||0.12|TWO_SIDED|95.0|0.35|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.35|0.12
91780654|NCT05465317|183441428|OTHER||Hazard Ratio (HR)|0.84||||0.52|TWO_SIDED|95.0|0.5|1.42|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.42|0.50|0.52
91780655|NCT05465317|183441430|OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.72|0.02
91780656|NCT05465317|183441430|OTHER||Hazard Ratio (HR)|0.82||||0.12|TWO_SIDED|95.0|0.65|1.05|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.05|0.65|0.12
91780657|NCT05465317|183441430|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.70|0.10
91780658|NCT05465317|183441431|OTHER||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.72|1.11|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.11|0.72|0.32
91780659|NCT05465317|183441431|OTHER||Hazard Ratio (HR)|0.9||||0.5|TWO_SIDED|95.0|0.65|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.65|0.50
91780660|NCT05465317|183441431|OTHER||Hazard Ratio (HR)|0.91||||0.5|TWO_SIDED|95.0|0.68|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.68|0.50
91780661|NCT05465317|183441432|OTHER||Hazard Ratio (HR)|0.75||||0.005|TWO_SIDED|95.0|0.62|0.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.92|0.62|0.005
91780662|NCT05465317|183441432|OTHER||Hazard Ratio (HR)|0.69||||0.03|TWO_SIDED|95.0|0.49|0.96|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.96|0.49|0.03
91780663|NCT05465317|183441432|OTHER||Hazard Ratio (HR)|0.8||||0.074|TWO_SIDED|95.0|0.63|1.02|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.02|0.63|0.074
91780664|NCT05465317|183441433|OTHER||Hazard Ratio (HR)|1.03||||0.46|TWO_SIDED|95.0|0.95|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.95|0.46
91780665|NCT05465317|183441433|OTHER||Hazard Ratio (HR)|1.04||||0.63|TWO_SIDED|95.0|0.9|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.90|0.63
91647663|NCT02065791|183187224|SUPERIORITY||Hazard Ratio (HR)|0.69|||=|0.0001|TWO_SIDED|95.0|0.57|0.83|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.83|0.57|=0.0001
91647664|NCT02065791|183187225|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0121|TWO_SIDED|95.0|0.67|0.95|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.95|0.67|=0.0121
91780666|NCT05465317|183441433|OTHER||Hazard Ratio (HR)|1.03||||0.52|TWO_SIDED|95.0|0.94|1.14|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.14|0.94|0.52
91780667|NCT05465317|183441434|OTHER||Hazard Ratio (HR)|0.81||||0.007|TWO_SIDED|95.0|0.7|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.70|0.007
91780668|NCT05465317|183441434|OTHER||Hazard Ratio (HR)|0.74||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.57|0.03
91780669|NCT05465317|183441434|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.71|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.71|0.10
91780670|NCT05465317|183441435|OTHER||Hazard Ratio (HR)|1.37||||0.15|TWO_SIDED|95.0|0.89|2.1|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.10|0.89|0.15
91780671|NCT05465317|183441435|OTHER||Hazard Ratio (HR)|1.05||||0.93|TWO_SIDED|95.0|0.4|2.72|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.72|0.40|0.93
91780672|NCT05465317|183441435|OTHER||Hazard Ratio (HR)|1.47||||0.113|TWO_SIDED|95.0|0.91|2.38|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.38|0.91|0.113
91780673|NCT05465317|183441436|OTHER||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.71|1.16|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.16|0.71|0.43
91780674|NCT05465317|183441436|OTHER||Hazard Ratio (HR)|0.8||||0.32|TWO_SIDED|95.0|0.51|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.51|0.32
91780675|NCT05465317|183441436|OTHER||Hazard Ratio (HR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.30|0.71|0.81
91780676|NCT05465317|183441437|OTHER||Hazard Ratio (HR)|0.93||||0.69|TWO_SIDED|95.0|0.65|1.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.33|0.65|0.69
91780677|NCT05465317|183441437|OTHER||Hazard Ratio (HR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.7|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.70|0.51|0.82
91780678|NCT05465317|183441437|OTHER||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.45|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.45|0.60|0.76
91780679|NCT05465317|183441438|OTHER||Hazard Ratio (HR)|0.68||||0.39|TWO_SIDED|95.0|0.29|1.62|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.62|0.29|0.39
91780680|NCT05465317|183441438|OTHER||Hazard Ratio (HR)|0.46||||0.34|TWO_SIDED|95.0|0.09|2.27|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.27|0.09|0.34
91780681|NCT05465317|183441438|OTHER||Hazard Ratio (HR)|0.82||||0.72|TWO_SIDED|95.0|0.29|2.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.33|0.29|0.72
91647665|NCT02065791|183187226|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0003|TWO_SIDED|95.0|0.47|0.8|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.80|0.47|=0.0003
91587420|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.35|TWO_SIDED|95.0|-0.25|0.71|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.25|0.350
91587421|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.493
91587422|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.922|TWO_SIDED|95.0|-0.53|0.48|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.48|-0.53|0.922
91587423|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.265|TWO_SIDED|95.0|-0.8|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.22|-0.80|0.265
91647666|NCT02065791|183187227|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.81|0.53|<0.0001
91647667|NCT02065791|183187228|SUPERIORITY||Hazard Ratio (HR)|0.78|||=|0.0502|TWO_SIDED|95.0|0.61|1.0|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.61|=0.0502
91780682|NCT05465317|183441439|OTHER||Hazard Ratio (HR)|0.84||||0.62|TWO_SIDED|95.0|0.43|1.66|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.66|0.43|0.62
91780683|NCT05465317|183441439|OTHER||Hazard Ratio (HR)|0.59||||0.31|TWO_SIDED|95.0|0.21|1.64|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.64|0.21|0.31
91780684|NCT05465317|183441439|OTHER||Hazard Ratio (HR)|1.16||||0.76|TWO_SIDED|95.0|0.46|2.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.92|0.46|0.76
91780685|NCT05465317|183441440|OTHER||Hazard Ratio (HR)|1.72|||<|0.001|TWO_SIDED|95.0|1.58|1.88|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.88|1.58|<0.001
91780686|NCT05465317|183441440|OTHER||Hazard Ratio (HR)|1.84|||<|0.001|TWO_SIDED|95.0|1.48|2.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.30|1.48|<0.001
91587424|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.342|TWO_SIDED|95.0|-0.28|0.81|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.81|-0.28|0.342
91587425|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.311
91647668|NCT02065791|183187229|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0727|TWO_SIDED|95.0|0.68|1.02|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||1.02|0.68|= 0.0727
91780687|NCT05465317|183441440|OTHER||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.54|1.87|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.87|1.54|<0.001
91780688|NCT04634253|183441441|SUPERIORITY||LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.361||0.017|TWO_SIDED|95.0|-1.6|-0.16|||Mixed Models Analysis|||||-0.16|-1.60|0.017
91587426|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.865|TWO_SIDED|95.0|-0.49|0.58|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.58|-0.49|0.865
91587427|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-0.89|0.18|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.89|0.193
91587428|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.17|TWO_SIDED|95.0|-0.17|0.97|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.97|-0.17|0.170
91587429|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.383
91647669|NCT02065791|183187230|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.86|0.63|0.0001
91647670|NCT04529096|183187231|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.1|1.14|||Bayesian Mixed Model Analysis|||||1.14|-0.10|
91647671|NCT04529096|183187232|SUPERIORITY||Posterior Mean Difference|1.05|||||TWO_SIDED|95.0|-0.46|2.56|||Bayesian Mixed Model Analysis|||||2.56|-0.46|
91647672|NCT04529096|183187233|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.25|0.58|||Bayesian Mixed Model Analysis|||||0.58|-0.25|
91647673|NCT04529096|183187234|SUPERIORITY||Posterior Mean Difference|0.48|||||TWO_SIDED|95.0|-0.19|1.17|||Bayesian Mixed Model Analysis|||||1.17|-0.19|
91647674|NCT04529096|183187235|SUPERIORITY||Posterior Mean Difference|4.63|||||TWO_SIDED|95.0|-3.51|12.59|||Bayesian Mixed Model Analysis|||||12.59|-3.51|
91780689|NCT04634253|183441441|SUPERIORITY||LS Mean|-1.09|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-1.73|-0.46|||Mixed Models Analysis|||||-0.46|-1.73|<0.001
91587430|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.802|TWO_SIDED|95.0|-0.48|0.62|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.62|-0.48|0.802
91587431|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.87|0.24|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.24|-0.87|0.260
91780690|NCT04634253|183441442|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.29|3.44|||Regression, Logistic|||||3.44|0.29|0.997
91780691|NCT04634253|183441442|SUPERIORITY||Odds Ratio (OR)|3.4||||0.032|TWO_SIDED|95.0|1.11|10.4|||Regression, Logistic|||||10.40|1.11|0.032
91780692|NCT04634253|183441443|SUPERIORITY||Odds Ratio (OR)|0.29||||0.235|TWO_SIDED|95.0|0.04|2.25|||Regression, Logistic|||||2.25|0.04|0.235
91780693|NCT04634253|183441443|SUPERIORITY||Odds Ratio (OR)|1.37||||0.661|TWO_SIDED|95.0|0.33|5.61|||Regression, Logistic|||||5.61|0.33|0.661
91780694|NCT04634253|183441444|SUPERIORITY||Odds Ratio (OR)|0.97||||0.965|TWO_SIDED|95.0|0.22|4.28|||Regression, Logistic|||||4.28|0.22|0.965
91780695|NCT04634253|183441444|SUPERIORITY||Odds Ratio (OR)|2.91||||0.098|TWO_SIDED|95.0|0.82|10.33|||Regression, Logistic|||||10.33|0.82|0.098
91780696|NCT04634253|183441445|SUPERIORITY||LS Mean Difference|-11.26|STANDARD_ERROR_OF_MEAN|3.71||0.003|TWO_SIDED|95.0|-18.65|-3.87|||Mixed Models Analysis|||||-3.87|-18.65|0.003
91780697|NCT04634253|183441445|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|3.265|<|0.001|TWO_SIDED|95.0|-19.61|-6.6|||Mixed Models Analysis|||||-6.60|-19.61|<0.001
91780698|NCT04634253|183441446|SUPERIORITY||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|3.782||0.008|TWO_SIDED|95.0|-17.83|-2.77|||Mixed Models Analysis|||||-2.77|-17.83|0.008
91780699|NCT04634253|183441446|SUPERIORITY||LS Mean Difference|-11.76|STANDARD_ERROR_OF_MEAN|3.282|<|0.001|TWO_SIDED|95.0|-18.29|-5.22|||Mixed Models Analysis|||||-5.22|-18.29|<0.001
91780700|NCT04634253|183441447|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.365||0.218|TWO_SIDED|95.0|-7.63|1.77|||ANCOVA|||Mental Component Score (MCS)||1.77|-7.63|0.218
91780701|NCT04634253|183441447|SUPERIORITY||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|2.065||0.578|TWO_SIDED|95.0|-2.95|5.26|||ANCOVA|||Mental Component Score (MCS)||5.26|-2.95|0.578
91780702|NCT04634253|183441447|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|2.368||0.396|TWO_SIDED|95.0|-2.69|6.73|||ANCOVA|||Physical Component Score (PCS)||6.73|-2.69|0.396
91780703|NCT04634253|183441447|SUPERIORITY||LS Mean Difference|1.42|STANDARD_ERROR_OF_MEAN|2.057||0.493|TWO_SIDED|95.0|-2.67|5.5|||ANCOVA|||Physical Component Score (PCS)||5.50|-2.67|0.493
91780704|NCT03486834|183441457|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).|Incidence Rate Estimate|2.9|||||TWO_SIDED|95.0|1.6|4.9||||||||4.9|1.6|
91780705|NCT03486834|183441457|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
91780706|NCT03486834|183441457|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|42.4|||||TWO_SIDED|95.0|-13.5|71.1||||||||71.1|-13.5|
91780707|NCT03486834|183441458|OTHER||Difference in Percent|59.8|||||TWO_SIDED|95.0|55.8|63.5||||||||63.5|55.8|
91780708|NCT03486834|183441458|OTHER||Difference in Percent|57.6|||||TWO_SIDED|95.0|53.5|61.5||||||||61.5|53.5|
91587432|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|0.98|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.21|0.199
91780709|NCT03486834|183441459|OTHER||Difference in Percent|15.9|||||TWO_SIDED|95.0|11.7|20.1||||||||20.1|11.7|
91780710|NCT03486834|183441459|OTHER||Difference in Percent|17.4|||||TWO_SIDED|95.0|13.3|21.6||||||||21.6|13.3|
91780711|NCT03486834|183441460|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
91780712|NCT03486834|183441460|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
91780713|NCT03486834|183441461|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|6.7|||||TWO_SIDED|95.0|4.6|9.5||||||||9.5|4.6|
91780714|NCT03486834|183441461|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
91780715|NCT03486834|183441461|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|-32.0|||||TWO_SIDED|95.0|-135.0|25.0||||||||25.0|-135.0|
91780716|NCT00888940|183441462|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
91780717|NCT02379091|183441469|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.351||0.086|TWO_SIDED|95.0|-1.31|0.09||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.09|-1.31|0.086
91780718|NCT02379091|183441469|SUPERIORITY_OR_OTHER||LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.366||0.107|TWO_SIDED|95.0|-1.32|0.13||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.13|-1.32|0.107
91780719|NCT02379091|183441469|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.347||0.01|TWO_SIDED|95.0|-1.61|-0.23||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||-0.23|-1.61|0.010
91587433|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.139
91780720|NCT03326713|183441484|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.2|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (TP vs TCN)||15.2|2.5|<.0001
91780721|NCT03326713|183441484|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.0001|TWO_SIDED|95.0|2.8|19.4|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TCN)||19.4|2.8|<.0001
91587434|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.441|TWO_SIDED|95.0|-0.35|0.8|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.80|-0.35|0.441
91587435|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.183|TWO_SIDED|95.0|-0.96|0.18|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.96|0.183
91587436|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.05|TWO_SIDED|95.0|0.0|1.23|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.23|-0.00|0.050
91587437|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.221
91647675|NCT04529096|183187236|SUPERIORITY||Posterior Mean Difference|0.05|||||TWO_SIDED|95.0|-0.4|0.51|||Bayesian Mixed Model Analysis|||||0.51|-0.40|
91780722|NCT03326713|183441484|SUPERIORITY||Odds Ratio (OR)|1.2||||1.2|TWO_SIDED|95.0|0.4|4.0|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TP)||4.0|0.4|1.2
91780723|NCT00935584|183441546|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
91780724|NCT00935584|183441546|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
91780725|NCT00935584|183441547|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
91780726|NCT00935584|183441547|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wicoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
91780727|NCT00935584|183441548|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
91780728|NCT00935584|183441548|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
91780729|NCT00935584|183441549|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
91780730|NCT00935584|183441549|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
91780731|NCT00935584|183441550|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
91780732|NCT00935584|183441550|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
91780733|NCT00935584|183441551|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
91780734|NCT00935584|183441551|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
91780735|NCT02129699|183441579|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.96||||0.355|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|Cox regression model for treatment effect, analysis adjusted for stratification factors||||1.19|0.78|0.355
91780736|NCT02129699|183441580|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.99||||0.459|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox|||||1.19|0.82|0.459
91780737|NCT06482125|183441614|SUPERIORITY||Odds Ratio (OR)|40.955||||0.001|TWO_SIDED|95.0|14.098|118.972|||Chi-squared, Corrected|||||118.972|14.098|0.001
91780738|NCT06482125|183441615|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.345|||||||Wilcoxon (Mann-Whitney)|||||||0.345
91780739|NCT06482125|183441616|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.450
91780740|NCT06482125|183441617|EQUIVALENCE|Reject H0 = the means are equivalent|Median Difference (Net)|1.0||||0.356|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.356
91521237|NCT02954354|182917044|SUPERIORITY|||||||0.4157||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.4157
91780741|NCT06482125|183441618|EQUIVALENCE|Reject H0 = the means are equivalent|Mean Difference (Final Values)|8.202||||0.07|TWO_SIDED|95.0|2.31|14.095|||t-test, 2 sided|||||14.095|2.310|0.07
91780742|NCT04701762|183441639|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|99.32|0.14|0.29|||GLM cumulative logit GEE model|||||0.29|0.14|<0.001
91780743|NCT04701762|183441640|SUPERIORITY||Risk Ratio (RR)|0.06|||<|0.001|TWO_SIDED|99.32|0.03|0.14|||Wilcoxon (Mann-Whitney)|||||0.14|0.03|<0.001
91780744|NCT04701762|183441641|SUPERIORITY||Risk Ratio (RR)|0.87||||0.53|TWO_SIDED|99.32|0.48|1.58|||GLM log-binomial model (log link)|||||1.58|0.48|0.53
91780745|NCT04701762|183441642|SUPERIORITY||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|0.92|3.1|||Mixed Models Analysis|||||3.1|0.92|<0.001
91647676|NCT04529096|183187237|SUPERIORITY||Posterior Mean Difference|-15.18|||||TWO_SIDED|95.0|-206.43|175.8|||Bayesian Mixed Model Analysis|||||175.80|-206.43|
91647677|NCT04529096|183187238|SUPERIORITY||Posterior Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.11|0.01|||Bayesian Mixed Model Analysis|||||0.01|-0.11|
91647678|NCT03467971|183187239|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|175.6652|||||TWO_SIDED|90.0|153.779|200.6664||||||Statistical Analysis for Metformin||200.6664|153.7790|
91780746|NCT04701762|183441643|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.27|TWO_SIDED|95.0|-0.34|1.2|||Mixed Models Analysis|||||1.2|-0.34|0.27
91780747|NCT05786651|183441644|EQUIVALENCE|Comparison of conditions|||||<|0.05|||||||ANOVA|||||||<.05
91780748|NCT05786651|183441645|EQUIVALENCE|Comparisons of mean values of conditions|||||<|0.05|||||||ANOVA|||||||<.05
91780749|NCT03397966|183441668|SUPERIORITY|||||||0.063||||||The investigators tested the effect of treatment (BNP vs. control) on the primary endpoint using mixed effects modeling, adjusting for treatment sequence, to assess the effect of treatment on each endpoint.|Mixed Models Analysis|||The primary endpoint is change in resting energy expenditure, calculated as final resting energy expenditure adjusted for baseline level, using linear regression. The null hypothesis is that there will be no significant effect of treatment on each endpoint. The investigators adhered to intention-to-treat principles. The test was performed with a significance level of 0.05.||||0.063
91780750|NCT03397966|183441669|SUPERIORITY|||||||0.07||||||Paired t-test.|t-test, 2 sided|||The null hypothesis is that there will be no significant effect of BNP on adipose gene expression of UCP1 compared with placebo. The alternative hypothesis is that UCP1 expression would be significantly higher after BNP treatment compared with placebo.||||0.07
91780751|NCT02873702|183441707|NON_INFERIORITY|Non-inferiority to lansoprazole if the lower bound of confidence interval (CI) for the treatment difference is greater than -10%.|Difference in Percentage|-2.65|||||TWO_SIDED|95.0|-26.59|21.3||||||Healing Period: Dexlansoprazole 60 mg versus Healing Period: Lansoprazole 30 mg||21.30|-26.59|
91780752|NCT03085797|183441735|SUPERIORITY||Difference in Medians|-0.73|||<|0.001|TWO_SIDED|95.0|-1.11|-0.34||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment,region,Baseline score,Baseline eosinophilcount(BEC). Par. with nasal surgery prior to Wk52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal|||-0.34|-1.11|<0.001
91647679|NCT03467971|183187239|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|104.457|||||TWO_SIDED|90.0|97.766|111.606||||||Statistical Analysis for Gliclazide||111.6060|97.7660|
91647680|NCT03467971|183187240|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|180.7734|||||TWO_SIDED|90.0|157.0135|208.1287||||||Statistical Analysis for Metformin||208.1287|157.0135|
91780753|NCT03085797|183441736|SUPERIORITY||Difference in Medians|-3.14|||<|0.001|TWO_SIDED|95.0|-4.09|-2.18||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.18|-4.09|<0.001
91780754|NCT03085797|183441737|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.43||||0.003|TWO_SIDED|95.0|0.25|0.76||p-Value was based on Cox Proportional Hazards Model.|Cox Proportional Hazards Model||Analysis using a Cox Proportional Hazards Model with covariates of treatment, geographic region, Baseline total endoscopic score (centrally read), Baseline nasal obstruction VAS, Baseline BEC, number of previous surgeries (1, 2, \>2 as ordinal).|||0.76|0.25|0.003
91780755|NCT03085797|183441738|OTHER||Difference in Medians|-3.18||||0.003|TWO_SIDED|95.0|-4.1|-2.26||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.26|-4.10|0.003
91780756|NCT03085797|183441739|OTHER||Difference in Medians|-16.49||||0.003|TWO_SIDED|95.0|-23.57|-9.42||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wk 52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal.|||-9.42|-23.57|0.003
91780757|NCT03085797|183441740|OTHER||Odds Ratio (OR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||p-Value was based on logistic regression model and is adjusted for multiplicity.|Regression, Logistic||Covariates: treatment group, geographic region, number of oral corticosteroids courses for NP in last 12 months(0,1,\>1 as ordinal), Baseline total endoscopic score(centrally read),Baseline nasal obstruction VAS score,log(e) Baseline eosinophil count.|||0.92|0.36|0.020
91780758|NCT03085797|183441741|OTHER||Difference in Medians|-2.68||||0.02|TWO_SIDED|95.0|-3.44|-1.91||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-1.91|-3.44|0.020
91647681|NCT03467971|183187240|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.0818|||||TWO_SIDED|90.0|98.0047|112.6699||||||Statistical Analysis for Gliclazide||112.6699|98.0047|
91647682|NCT03467971|183187241|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|127.7779|||||TWO_SIDED|90.0|110.2732|148.0612||||||Statistical Analysis for Metformin||148.0612|110.2732|
91647683|NCT03467971|183187241|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.4183|||||TWO_SIDED|90.0|94.5723|117.5081||||||Statistical Analysis for Gliclazide||117.5081|94.5723|
91709040|NCT03035916|183311323|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91587438|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.526|TWO_SIDED|95.0|-0.4|0.79|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.40|0.526
91587439|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.232|TWO_SIDED|95.0|-0.96|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.96|0.232
91587440|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.089|TWO_SIDED|95.0|-0.08|1.19|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.19|-0.08|0.089
91587441|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.190
91587442|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.365|TWO_SIDED|95.0|-0.31|0.85|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.85|-0.31|0.365
91587443|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.295|TWO_SIDED|95.0|-0.89|0.27|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.27|-0.89|0.295
91587444|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.069|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.20|-0.05|0.069
91587445|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.197
91587446|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.309|TWO_SIDED|95.0|-0.29|0.92|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.92|-0.29|0.309
91587447|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.359|TWO_SIDED|95.0|-0.89|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.33|-0.89|0.359
91587448|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.072|TWO_SIDED|95.0|-0.05|1.25|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.25|-0.05|0.072
91587449|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.151
91587450|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.09|TWO_SIDED|95.0|-0.1|1.32|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.32|-0.10|0.090
91587451|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.889|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.66|-0.76|0.889
91780759|NCT03085797|183441742|OTHER||Difference in Medians|-0.37||||0.02|TWO_SIDED|95.0|-0.65|-0.08||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-0.08|-0.65|0.020
91780760|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Results presented were Bonferonni-corrected for a mid-point safety analysis||Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .||||<.0001
91780761|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||=|0.56|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=.56
91587452|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.7||||0.088|TWO_SIDED|95.0|-0.1|1.42|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.42|-0.10|0.088
91587453|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.673
91587454|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.393|TWO_SIDED|95.0|-0.41|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.41|0.393
91587455|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.887|TWO_SIDED|95.0|-0.67|0.78|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.78|-0.67|0.887
91587456|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.507|TWO_SIDED|95.0|-0.51|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.51|0.507
91587457|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.873
91587458|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.605|TWO_SIDED|95.0|-0.58|1.0|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.00|-0.58|0.605
91587459|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.86|TWO_SIDED|95.0|-0.72|0.86|||ANOVA|||26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.86|-0.72|0.860
91587460|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.751|TWO_SIDED|95.0|-0.71|0.98|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.71|0.751
91587461|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.528
91780762|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||<|0.0009|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0009
91587462|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.486|TWO_SIDED|95.0|-1.09|0.52|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-1.09|0.486
91780763|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
91780764|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.006
91780765|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
91780766|NCT01554241|183441745|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
91780767|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||analyses were corrected for multiple comparisons (Bonferroni)|ANOVA|||||||<.0001
91780768|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=0.47
91780769|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.002
91780770|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
91780771|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.02
91780772|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
91780773|NCT01554241|183441746|SUPERIORITY_OR_OTHER||||||<|0.0003|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0003
91709041|NCT03035916|183311323|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91780774|NCT03198507|183441749|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0||||Statistical testing was 2 sided and performed using a significance (alpha) level of 0.05.|t-test, 2 sided|||||||0.0001
91780775|NCT03198507|183441752|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91780776|NCT04614974|183441754|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91780777|NCT04614974|183441755|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91587463|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.61|TWO_SIDED|95.0|-0.6|1.02|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.02|-0.60|0.610
91587464|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.261|TWO_SIDED|95.0|-1.36|0.37|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.37|-1.36|0.261
91587465|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.943|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.943
91780778|NCT04614974|183441756|OTHER|||||||0.5|||||||McNemar|||Noisy breathing pre/post||||0.5
91780779|NCT04614974|183441756|OTHER|||||||0.01|||||||McNemar|||Noisy breathing pre/post||||0.01
91780780|NCT04614974|183441756|OTHER|||||||0.2|||||||McNemar|||Stridor pre/post||||0.2
91780781|NCT04614974|183441756|SUPERIORITY|||||||0.02|||||||McNemar|||Stridor pre/post||||0.02
91780782|NCT04614974|183441756|OTHER|||||||0.5|||||||McNemar|||Chest wall retractions pre/post||||0.5
91780783|NCT04614974|183441756|OTHER|||||||1|||||||McNemar|||Chest wall retractions pre/post||||1.0
91780784|NCT04614974|183441756|OTHER|||||||1|||||||McNemar|||Apnea pre/post||||1.0
91780785|NCT04614974|183441757|OTHER|||||||0.5|||||||McNemar|||Emesis pre/post||||0.5
91780786|NCT04614974|183441757|OTHER|||||||0.07|||||||McNemar|||Emesis pre/post||||0.07
91780787|NCT04614974|183441757|SUPERIORITY|||||||0.06|||||||McNemar|||Choking pre/post||||0.06
91780788|NCT04614974|183441757|OTHER|||||||1|||||||McNemar|||Choking pre/post||||1.0
91780789|NCT04614974|183441757|OTHER|||||||0.02|||||||McNemar|||Coughing pre/post||||0.02
91780790|NCT04614974|183441757|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Coughing pre/post||||1.0
91780791|NCT04614974|183441757|OTHER|||||||1|||||||McNemar|||Gagging pre/post||||1.0
91780792|NCT04614974|183441758|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91780793|NCT04614974|183441759|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91780794|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA. Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
91780795|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|10.71|STANDARD_ERROR_OF_MEAN|6.26||0.0873|TWO_SIDED|60.0|5.44|15.98|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||15.98|5.44|0.0873
91780796|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|3.93|STANDARD_ERROR_OF_MEAN|5.71||0.4912|TWO_SIDED|60.0|-0.87|8.74|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||8.74|-0.87|0.4912
91780797|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|11.06|STANDARD_ERROR_OF_MEAN|6.61||0.0942|TWO_SIDED|60.0|5.5|16.62|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||16.62|5.50|0.0942
91780798|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|7.31|STANDARD_ERROR_OF_MEAN|6.36||0.2499|TWO_SIDED|60.0|1.96|12.66|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||12.66|1.96|0.2499
91780799|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|13.47|STANDARD_ERROR_OF_MEAN|7.1||0.058|TWO_SIDED|60.0|7.49|19.45|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||19.45|7.49|0.0580
91780800|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|12.62|STANDARD_ERROR_OF_MEAN|7.09||0.075|TWO_SIDED|60.0|6.66|18.59|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||18.59|6.66|0.0750
91780801|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|16.66|STANDARD_ERROR_OF_MEAN|7.75||0.0316|TWO_SIDED|60.0|10.14|23.19|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||23.19|10.14|0.0316
91780802|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||19.53|6.90|0.0783
91780803|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||27.96|12.58|0.0266
91587466|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.733|TWO_SIDED|95.0|-0.96|0.68|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.68|-0.96|0.733
91587467|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.902|TWO_SIDED|95.0|-0.87|0.77|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.77|-0.87|0.902
91587468|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.84|TWO_SIDED|95.0|-0.97|0.79|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.97|0.840
91587469|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.758
91587470|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.493|TWO_SIDED|95.0|-1.12|0.54|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.54|-1.12|0.493
91587471|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.974|TWO_SIDED|95.0|-0.84|0.82|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.82|-0.84|0.974
91587472|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.543|TWO_SIDED|95.0|-1.16|0.61|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-1.16|0.543
91587473|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.238|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.238
91587474|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.106|TWO_SIDED|95.0|-1.46|0.14|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-1.46|0.106
91780804|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||19.53|6.90|0.0783
91780805|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||27.96|12.58|0.0266
91780806|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|11.02|STANDARD_ERROR_OF_MEAN|7.74||0.1545|TWO_SIDED|60.0|4.51|17.54|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||17.54|4.51|0.1545
91587475|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.817|TWO_SIDED|95.0|-0.9|0.71|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.90|0.817
91709042|NCT03035916|183311323|OTHER|||||||0.464|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.464
91587476|NCT01794923|183064080|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.197|TWO_SIDED|95.0|-1.43|0.3|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.30|-1.43|0.197
91587477|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.702|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.702
91587478|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.8||||0.664|TWO_SIDED|95.0|-9.91|15.53|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||15.53|-9.91|0.664
91587479|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.0||||0.637|TWO_SIDED|95.0|-15.77|9.68|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||9.68|-15.77|0.637
91587480|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9||||0.401|TWO_SIDED|95.0|-7.85|19.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||19.57|-7.85|0.401
91709043|NCT03035916|183311323|OTHER|||||||0.007|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.007
91780807|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|18.08|STANDARD_ERROR_OF_MEAN|9.34||0.0528|TWO_SIDED|60.0|10.22|25.94|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||25.94|10.22|0.0528
91780808|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|14.03|STANDARD_ERROR_OF_MEAN|8.45||0.0968|TWO_SIDED|60.0|6.92|21.14|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||21.14|6.92|0.0968
91780809|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||23.85|7.81|0.0966
91780810|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||24.42|9.72|0.0507
91780811|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||23.85|7.81|0.0966
91780812|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||24.42|9.72|0.0507
91780813|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||23.85|7.81|0.0966
91780814|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|18.17|STANDARD_ERROR_OF_MEAN|9.56||0.0574|TWO_SIDED|60.0|10.12|26.22|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||26.22|10.12|0.0574
91780815|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|21.08|STANDARD_ERROR_OF_MEAN|11.84||0.0749|TWO_SIDED|60.0|11.12|31.04|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||31.04|11.12|0.0749
91780816|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|3.65|STANDARD_ERROR_OF_MEAN|4.44||0.4116|TWO_SIDED|60.0|-0.09|7.38|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.38|-0.09|0.4116
91780817|NCT00658359|183441764|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.98|STANDARD_ERROR_OF_MEAN|3.69||0.7895|TWO_SIDED|60.0|-4.09|2.12|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.12|-4.09|0.7895
91780818|NCT00658359|183441765|SUPERIORITY_OR_OTHER||Estimated rate difference|2.4|STANDARD_ERROR_OF_MEAN|5.9||0.683|TWO_SIDED|95.0|-9.1|13.9|||Chi-squared||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||13.9|-9.1|0.683
91780819|NCT00658359|183441765|SUPERIORITY_OR_OTHER||Estimated rate difference|3.9|STANDARD_ERROR_OF_MEAN|6.2||0.529|TWO_SIDED|95.0|-8.3|16.1|||Chi-squared||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||16.1|-8.3|0.529
91780820|NCT00658359|183441766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|STANDARD_ERROR_OF_MEAN|5.04||0.0699|TWO_SIDED|60.0|4.97|13.49|||Mixed Models Analysis||Tofacitinib LI minus CsA|||13.49|4.97|0.0699
91780821|NCT00658359|183441766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|STANDARD_ERROR_OF_MEAN|6.32||0.1958|TWO_SIDED|60.0|2.89|13.58|||Mixed Models Analysis||Tofacitinib MI minus CsA|||13.58|2.89|0.1958
91780822|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
91780823|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.41|STANDARD_ERROR_OF_MEAN|4.89||0.934|TWO_SIDED|60.0|-4.52|3.71|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||3.71|-4.52|0.9340
91780824|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||5.08|-3.88|0.9106
91780825|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.30|-6.29|0.6960
91780826|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||5.08|-3.88|0.9106
91780827|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.30|-6.29|0.6960
91780828|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||5.08|-3.88|0.9106
91780829|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.30|-6.29|0.6960
91521238|NCT02954354|182917044|SUPERIORITY|||||||0.5908||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||144 hours||||0.5908
91587481|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.926
91587482|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.743|TWO_SIDED|95.0|-29.51|21.1|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||21.10|-29.51|0.743
91587483|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8||||0.952|TWO_SIDED|95.0|-24.55|26.08|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.08|-24.55|0.952
91780830|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.18|STANDARD_ERROR_OF_MEAN|5.56||0.8322|TWO_SIDED|60.0|-5.86|3.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||3.50|-5.86|0.8322
91521239|NCT02954354|182917044|SUPERIORITY|||||||0.2975||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2975
91780831|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.77|STANDARD_ERROR_OF_MEAN|5.35||0.4809|TWO_SIDED|60.0|-8.27|0.73|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||0.73|-8.27|0.4809
91521240|NCT02954354|182917044|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
91521241|NCT02954354|182917044|SUPERIORITY|||||||0.5573||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.m|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.5573
91780832|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.62|-8.31|0.5704
91780833|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-1.14|-10.73|0.2972
91780834|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||1.62|-8.31|0.5704
91521242|NCT02954354|182917045|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2557|TWO_SIDED|95.0|-0.24|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.06|-0.24|0.2557
91521243|NCT02954354|182917045|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.46|-0.22||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||-0.22|-0.46|<0.0001
91521244|NCT02954354|182917045|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.52|-0.29||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||-0.29|-0.52|<0.0001
91587484|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.719|TWO_SIDED|95.0|-32.25|22.3|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||22.30|-32.25|0.719
91780835|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-1.14|-10.73|0.2972
91780836|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.62|-8.31|0.5704
91780837|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-1.14|-10.73|0.2972
91780838|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.62|-8.31|0.5704
91521245|NCT02954354|182917045|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.48|-0.27||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||-0.27|-0.48|<0.0001
91521246|NCT02954354|182917045|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.31|-0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||-0.13|-0.31|<0.0001
91521247|NCT02954354|182917045|SUPERIORITY||LS Mean Dfference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.4484|TWO_SIDED|95.0|-0.13|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.06|-0.13|0.4484
91521248|NCT02954354|182917045|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.5963|TWO_SIDED|95.0|-0.07|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||0.11|-0.07|0.5963
91587485|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.284
91587486|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-19.0||||0.171|TWO_SIDED|95.0|-46.21|8.28|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||8.28|-46.21|0.171
91780839|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-1.14|-10.73|0.2972
91780840|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.62|-8.31|0.5704
91780841|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-1.14|-10.73|0.2972
91780842|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.62|-8.31|0.5704
91780843|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-1.14|-10.73|0.2972
91780844|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.89|-0.39|0.4455
91780845|NCT00658359|183441768|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
91780846|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.52|STANDARD_ERROR_OF_MEAN|5.71||0.0654|TWO_SIDED|60.0|-15.33|-5.71|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-5.71|-15.33|0.0654
91780847|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.08|STANDARD_ERROR_OF_MEAN|6.37||0.3398|TWO_SIDED|60.0|-11.43|-0.72|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.72|-11.43|0.3398
91780848|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.75|STANDARD_ERROR_OF_MEAN|6.23||0.1601|TWO_SIDED|60.0|-13.99|-3.51|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-3.51|-13.99|0.1601
91780849|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.18|-13.10|0.2390
91780850|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.08|STANDARD_ERROR_OF_MEAN|6.4||0.2685|TWO_SIDED|60.0|-12.47|-1.7|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.70|-12.47|0.2685
91780851|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.18|-13.10|0.2390
91780852|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.81|STANDARD_ERROR_OF_MEAN|6.55||0.1785|TWO_SIDED|60.0|-14.32|-3.3|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.30|-14.32|0.1785
91780853|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-9.37|STANDARD_ERROR_OF_MEAN|6.63||0.158|TWO_SIDED|60.0|-14.95|-3.78|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.78|-14.95|0.1580
91780854|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.27|STANDARD_ERROR_OF_MEAN|6.81||0.0718|TWO_SIDED|60.0|-18.0|-6.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-6.53|-18.00|0.0718
91780855|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.83|STANDARD_ERROR_OF_MEAN|6.9||0.0629|TWO_SIDED|60.0|-18.63|-7.02|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-7.02|-18.63|0.0629
91780856|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate differences|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-9.94|-21.84|0.0246
91780857|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-10.43|-22.46|0.0214
91780858|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-9.94|-21.84|0.0246
91780859|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-10.43|-22.46|0.0214
91780860|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-11.93|-24.12|0.0128
91780861|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-12.42|-24.74|0.0111
91647684|NCT00883129|183187287|SUPERIORITY_OR_OTHER|||||||0.24||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the FVC %-predicted. Covariates were %-predicted FVC, HRCT-defined extent of lung fibrosis in the lobe of maximum involvement, and terms for time-trend, treatment and treatment-time trend interactions.||||0.24
91780862|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-11.93|-24.12|0.0128
91780863|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-12.42|-24.74|0.0111
91780864|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-11.93|-24.12|0.0128
91521249|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.0937|TWO_SIDED|95.0|-0.02|0.24||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.24|-0.02|0.0937
91780865|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-12.42|-24.74|0.0111
91780866|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-11.93|-24.12|0.0128
91587487|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.2||||0.875|TWO_SIDED|95.0|-25.08|29.42|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||29.42|-25.08|0.875
91587488|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1||||0.157|TWO_SIDED|95.0|-50.5|8.23|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||8.23|-50.50|0.157
91780867|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-12.42|-24.74|0.0111
91780868|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.4|STANDARD_ERROR_OF_MEAN|5.41||0.1715|TWO_SIDED|60.0|-11.95|-2.84|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||-2.84|-11.95|0.1715
91780869|NCT00658359|183441769|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.8|STANDARD_ERROR_OF_MEAN|5.87||0.4131|TWO_SIDED|60.0|-9.74|0.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.14|-9.74|0.4131
91780870|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
91780871|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|1.45|STANDARD_ERROR_OF_MEAN|5.18||0.7799|TWO_SIDED|60.0|-2.91|5.8|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||5.80|-2.91|0.7799
91780872|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||3.65|-5.63|0.8572
91780873|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.73|STANDARD_ERROR_OF_MEAN|5.56||0.7555|TWO_SIDED|60.0|-6.41|2.95|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.95|-6.41|0.7555
91780874|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||3.65|-5.63|0.8572
91780875|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|3.82|STANDARD_ERROR_OF_MEAN|6.22||0.539|TWO_SIDED|60.0|-1.41|9.06|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||9.06|-1.41|0.5390
91780876|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.64|STANDARD_ERROR_OF_MEAN|5.7||0.6432|TWO_SIDED|60.0|-7.44|2.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.16|-7.44|0.6432
91780877|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|2.18|STANDARD_ERROR_OF_MEAN|6.39||0.7336|TWO_SIDED|60.0|-3.2|7.55|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||7.55|-3.20|0.7336
91780878|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.74|STANDARD_ERROR_OF_MEAN|6.57||0.9099|TWO_SIDED|60.0|-6.28|4.79|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||4.79|-6.28|0.9099
91780879|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|0.77|STANDARD_ERROR_OF_MEAN|6.87||0.9106|TWO_SIDED|60.0|-5.01|6.56|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||6.56|-5.01|0.9106
91780880|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|6.91||0.5244|TWO_SIDED|60.0|-10.22|1.42|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.42|-10.22|0.5244
91587489|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.699|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.699
91780881|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.9|STANDARD_ERROR_OF_MEAN|7.38||0.9029|TWO_SIDED|60.0|-7.11|5.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.31|-7.11|0.9029
91780882|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.58|STANDARD_ERROR_OF_MEAN|7.38||0.7267|TWO_SIDED|60.0|-8.78|3.63|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.63|-8.78|0.7267
91780883|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.73|STANDARD_ERROR_OF_MEAN|7.52||0.7168|TWO_SIDED|60.0|-9.06|3.6|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.60|-9.06|0.7168
91780884|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.91|-10.72|0.5574
91780885|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.56|STANDARD_ERROR_OF_MEAN|7.65||0.5515|TWO_SIDED|60.0|-10.99|1.88|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.88|-10.99|0.5515
91780886|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.91|-10.72|0.5574
91780887|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||4.33|-8.92|0.7704
91780888|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.91|-10.72|0.5574
91780889|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||4.33|-8.92|0.7704
91780890|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.44|STANDARD_ERROR_OF_MEAN|7.83||0.9551|TWO_SIDED|60.0|-7.03|6.15|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||6.15|-7.03|0.9551
91780891|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||4.33|-8.92|0.7704
91780892|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test|||Month 12||7.89|-0.39|0.4455
91780893|NCT00658359|183441770|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
91780894|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.98|STANDARD_ERROR_OF_MEAN|6.67||0.2957|TWO_SIDED|60.0|-12.6|-1.36|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-1.36|-12.60|0.2957
91780895|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.65|STANDARD_ERROR_OF_MEAN|7.14||0.6097|TWO_SIDED|60.0|-9.66|2.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||2.37|-9.66|0.6097
91780896|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|6.79||0.2064|TWO_SIDED|60.0|-14.28|-2.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.86|-14.28|0.2064
91587490|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.8||||0.433|TWO_SIDED|95.0|-62.58|26.9|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.90|-62.58|0.433
91587491|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.966|TWO_SIDED|95.0|-45.73|43.78|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||43.78|-45.73|0.966
91587492|NCT01794923|183064081|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-16.9||||0.491|TWO_SIDED|95.0|-65.08|31.36|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||31.36|-65.08|0.491
91587493|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.219
91587494|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.214|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.08|-0.37|0.214
91587495|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.555|TWO_SIDED|95.0|-0.16|0.29|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.29|-0.16|0.555
91647685|NCT00883129|183187287|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the FVC %-predicted for each treatment arm independently.||||<0.05
91780897|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.24|STANDARD_ERROR_OF_MEAN|7.25||0.4696|TWO_SIDED|60.0|-11.34|0.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||0.86|-11.34|0.4696
91587496|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.09|TWO_SIDED|95.0|-0.45|0.03|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.03|-0.45|0.090
91587497|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.161
91587498|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.056|TWO_SIDED|95.0|-0.55|0.01|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.01|-0.55|0.056
91587499|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.395|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.16|-0.40|0.395
91587500|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.324|TWO_SIDED|95.0|-0.45|0.15|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.15|-0.45|0.324
91587501|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.246
91587502|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.094|TWO_SIDED|95.0|-0.68|0.05|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.05|-0.68|0.094
91587503|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.491|TWO_SIDED|95.0|-0.5|0.24|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.24|-0.50|0.491
91587504|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.359|TWO_SIDED|95.0|-0.58|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-0.58|0.359
91587505|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.294
91587506|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.136|TWO_SIDED|95.0|-0.74|0.1|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.10|-0.74|0.136
91587507|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.293|TWO_SIDED|95.0|-0.65|0.2|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-0.65|0.293
91780898|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.64|-14.50|0.2238
91780899|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.96|STANDARD_ERROR_OF_MEAN|7.52||0.5093|TWO_SIDED|60.0|-11.29|1.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||1.37|-11.29|0.5093
91587508|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.682|TWO_SIDED|95.0|-0.55|0.36|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.55|0.682
91587509|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.747
91587510|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.592|TWO_SIDED|95.0|-0.6|0.34|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.60|0.592
91587511|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.473|TWO_SIDED|95.0|-0.64|0.3|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.64|0.473
91587512|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.866|TWO_SIDED|95.0|-0.46|0.55|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.55|-0.46|0.866
91709044|NCT03035916|183311323|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91780900|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-2.64|-14.50|0.2238
91780901|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.16|STANDARD_ERROR_OF_MEAN|7.89||0.7846|TWO_SIDED|60.0|-8.8|4.48|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||4.48|-8.80|0.7846
91780902|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.3|STANDARD_ERROR_OF_MEAN|7.16||0.1501|TWO_SIDED|60.0|-16.33|-4.28|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-4.28|-16.33|0.1501
91780903|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.89|STANDARD_ERROR_OF_MEAN|8.0||0.6263|TWO_SIDED|60.0|-10.62|2.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.84|-10.62|0.6263
91780904|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-6.25|-18.62|0.0905
91780905|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||0.84|-12.90|0.4604
91780906|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-6.25|-18.62|0.0905
91780907|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||0.84|-12.90|0.4604
91780908|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-6.25|-18.62|0.0905
91780909|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||0.84|-12.90|0.4604
91780910|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-6.25|-18.62|0.0905
91587513|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.776|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.776
91780911|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||0.84|-12.90|0.4604
91587514|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.59|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.43|-0.59|0.761
91587515|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.477|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.33|-0.69|0.477
91587516|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.705|TWO_SIDED|95.0|-0.44|0.65|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-0.44|0.705
91587517|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.600
91587518|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.931|TWO_SIDED|95.0|-0.52|0.56|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.56|-0.52|0.931
91587519|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-0.78|0.3|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.78|0.381
91587520|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.371|TWO_SIDED|95.0|-0.32|0.85|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.85|-0.32|0.371
91587521|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.670
91587522|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.941|TWO_SIDED|95.0|-0.54|0.58|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.58|-0.54|0.941
91587523|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.437|TWO_SIDED|95.0|-0.78|0.34|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.78|0.437
91587524|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.429|TWO_SIDED|95.0|-0.36|0.84|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.84|-0.36|0.429
91587525|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.484
91587526|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.504|TWO_SIDED|95.0|-0.38|0.78|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.78|-0.38|0.504
91587527|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.528|TWO_SIDED|95.0|-0.77|0.4|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-0.77|0.528
91587528|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.229|TWO_SIDED|95.0|-0.24|1.01|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.01|-0.24|0.229
91587529|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.536
91587530|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.49|0.7|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.70|-0.49|0.728
91587531|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-0.84|0.35|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-0.84|0.414
91587532|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.28|TWO_SIDED|95.0|-0.29|0.99|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.29|0.280
91587533|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.402
91587534|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.513|TWO_SIDED|95.0|-0.41|0.81|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.81|-0.41|0.513
91587535|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.424|TWO_SIDED|95.0|-0.86|0.36|||ANOVA|||11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.86|0.424
91587536|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.178|TWO_SIDED|95.0|-0.21|1.1|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.10|-0.21|0.178
91587537|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.442|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.442
91587538|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.357|TWO_SIDED|95.0|-0.33|0.91|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.91|-0.33|0.357
91780912|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-6.25|-18.62|0.0905
91587539|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.675|TWO_SIDED|95.0|-0.75|0.49|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.49|-0.75|0.675
91780913|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||0.84|-12.90|0.4604
91780914|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-6.25|-18.62|0.0905
91780915|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||0.84|-12.90|0.4604
91780916|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.29|STANDARD_ERROR_OF_MEAN|6.31||0.7166|TWO_SIDED|60.0|-7.61|3.02|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||3.02|-7.61|0.7166
91780917|NCT00658359|183441771|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.51|STANDARD_ERROR_OF_MEAN|6.24||0.4692|TWO_SIDED|60.0|-9.76|0.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.73|-9.76|0.4692
91780918|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
91780919|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
91780920|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
91780921|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
91780922|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
91780923|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
91780924|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
91587540|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.25|1.09|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.09|-0.25|0.215
91587541|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.643
91587542|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.466|TWO_SIDED|95.0|-0.46|0.99|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.46|0.466
91780925|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
91780926|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
91780927|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
91780928|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
91780929|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
91780930|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
91780931|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
91780932|NCT00658359|183441772|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||5.57|1.46|0.1503
91587543|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.818|TWO_SIDED|95.0|-0.81|0.64|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.64|-0.81|0.818
91587544|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.373|TWO_SIDED|95.0|-0.43|1.13|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.13|-0.43|0.373
91587545|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.984
91587546|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.874|TWO_SIDED|95.0|-0.79|0.68|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.68|-0.79|0.874
91647686|NCT00883129|183187287|SUPERIORITY_OR_OTHER|||||||0.55||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of FVC %-predicted at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the FVC %-predicted.||||0.55
91780933|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.85|STANDARD_ERROR_OF_MEAN|1.83||0.3128|TWO_SIDED|60.0|-3.4|-0.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.31|-3.40|0.3128
91780934|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.91|0.26|0.3134
91780935|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.26|STANDARD_ERROR_OF_MEAN|2.42||0.9129|TWO_SIDED|60.0|-2.3|1.77|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||1.77|-2.30|0.9129
91780936|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.91|0.26|0.3134
91780937|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.16|-7.23|0.2447
91780938|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.91|0.26|0.3134
91780939|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-1.16|-7.23|0.2447
91780940|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.91|0.26|0.3134
91780941|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.44|STANDARD_ERROR_OF_MEAN|4.74||0.1164|TWO_SIDED|60.0|-11.43|-3.45|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-3.45|-11.43|0.1164
91780942|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.93|1.52|0.1545
91780943|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-0.94|-9.66|0.3061
91780944|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.93|1.52|0.1545
91780945|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-0.94|-9.66|0.3061
91780946|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||8.73|3.10|0.0774
91780947|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.59|-7.82|0.5772
91780948|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||8.73|3.10|0.0774
91780949|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.59|-7.82|0.5772
91780950|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||8.73|3.10|0.0774
91780951|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.59|-7.82|0.5772
91780952|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||8.73|3.10|0.0774
91780953|NCT00658359|183441773|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.59|-7.82|0.5772
91780954|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.35|STANDARD_ERROR_OF_MEAN|8.15||0.0786|TWO_SIDED|60.0|7.49|21.22|||Mixed Models Analysis|||Month 15||21.22|7.49|0.0786
91780955|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_ERROR_OF_MEAN|8.5||0.736|TWO_SIDED|60.0|-10.03|4.29|||Mixed Models Analysis|||Month 15||4.29|-10.03|0.7360
91780956|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.16|STANDARD_ERROR_OF_MEAN|8.19||0.1377|TWO_SIDED|60.0|5.27|19.05|||Mixed Models Analysis|||Month 18||19.05|5.27|0.1377
91780957|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|8.56||0.4131|TWO_SIDED|60.0|-14.21|0.2|||Mixed Models Analysis|||Month 18||0.20|-14.21|0.4131
91780958|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.52|STANDARD_ERROR_OF_MEAN|8.35||0.1057|TWO_SIDED|60.0|6.49|20.55|||Mixed Models Analysis|||Month 24||20.55|6.49|0.1057
91780959|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|8.95||0.1402|TWO_SIDED|60.0|-20.75|-5.68|||Mixed Models Analysis|||Month 24||-5.68|-20.75|0.1402
91587547|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.99|TWO_SIDED|95.0|-0.73|0.74|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.74|-0.73|0.990
91587548|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.875|TWO_SIDED|95.0|-0.85|0.73|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.73|-0.85|0.875
91587549|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.841
91587550|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.58|TWO_SIDED|95.0|-1.01|0.57|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.57|-1.01|0.580
91780960|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|9.13||0.0542|TWO_SIDED|60.0|9.91|25.29|||Mixed Models Analysis|||Month 30||25.29|9.91|0.0542
91780961|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|STANDARD_ERROR_OF_MEAN|10.09||0.3866|TWO_SIDED|60.0|0.24|17.24|||Mixed Models Analysis|||Month 30||17.24|0.24|0.3866
91780962|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|9.72||0.1981|TWO_SIDED|60.0|4.33|20.71|||Mixed Models Analysis|||Month 36||20.71|4.33|0.1981
91780963|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|STANDARD_ERROR_OF_MEAN|12.07||0.6397|TWO_SIDED|60.0|-15.81|4.51|||Mixed Models Analysis|||Month 36||4.51|-15.81|0.6397
91780964|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.93|STANDARD_ERROR_OF_MEAN|10.19||0.0508|TWO_SIDED|60.0|11.35|28.51|||Mixed Models Analysis|||Month 42||28.51|11.35|0.0508
91780965|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.42|STANDARD_ERROR_OF_MEAN|12.9||0.5143|TWO_SIDED|60.0|-2.45|19.28|||Mixed Models Analysis|||Month 42||19.28|-2.45|0.5143
91780966|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.26|STANDARD_ERROR_OF_MEAN|10.45||0.0021|TWO_SIDED|60.0|23.46|41.06|||Mixed Models Analysis|||Month 48||41.06|23.46|0.0021
91780967|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.73|STANDARD_ERROR_OF_MEAN|13.47||0.5661|TWO_SIDED|60.0|-19.07|3.61|||Mixed Models Analysis|||Month 48||3.61|-19.07|0.5661
91780968|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.2|STANDARD_ERROR_OF_MEAN|10.54||0.0057|TWO_SIDED|60.0|20.33|38.08|||Mixed Models Analysis|||Month 54||38.08|20.33|0.0057
91780969|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|STANDARD_ERROR_OF_MEAN|13.89||0.4504|TWO_SIDED|60.0|-22.18|1.21|||Mixed Models Analysis|||Month 54||1.21|-22.18|0.4504
91780970|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.37|STANDARD_ERROR_OF_MEAN|11.39||0.0078|TWO_SIDED|60.0|20.78|39.96|||Mixed Models Analysis|||Month 60||39.96|20.78|0.0078
91780971|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|14.44||0.6802|TWO_SIDED|60.0|-18.11|6.2|||Mixed Models Analysis|||Month 60||6.20|-18.11|0.6802
91587551|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.958|TWO_SIDED|95.0|-0.81|0.77|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.77|-0.81|0.958
91587552|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.643|TWO_SIDED|95.0|-1.05|0.65|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-1.05|0.643
91587553|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.299
91780972|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|STANDARD_ERROR_OF_MEAN|12.08||0.0216|TWO_SIDED|60.0|17.61|37.95|||Mixed Models Analysis|||Month 66||37.95|17.61|0.0216
91780973|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|15.12||0.9026|TWO_SIDED|60.0|-14.58|10.88|||Mixed Models Analysis|||Month 66||10.88|-14.58|0.9026
91780974|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38|STANDARD_ERROR_OF_MEAN|12.91||0.1146|TWO_SIDED|60.0|9.51|31.24|||Mixed Models Analysis|||Month 72||31.24|9.51|0.1146
91780975|NCT00658359|183441775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|STANDARD_ERROR_OF_MEAN|15.48||0.6918|TWO_SIDED|60.0|-19.18|6.9|||Mixed Models Analysis|||Month 72||6.90|-19.18|0.6918
91780976|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.62|STANDARD_ERROR_OF_MEAN|6.57||0.3139|TWO_SIDED|60.0|1.09|12.14|||Mixed Models Analysis|||Month 15||12.14|1.09|0.3139
91780977|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|6.75||0.5176|TWO_SIDED|60.0|-10.06|1.31|||Mixed Models Analysis|||Month 15||1.31|-10.06|0.5176
91780978|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.54|STANDARD_ERROR_OF_MEAN|6.56||0.3191|TWO_SIDED|60.0|1.02|12.06|||Mixed Models Analysis|||Month 18||12.06|1.02|0.3191
91780979|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|6.73||0.6608|TWO_SIDED|60.0|-8.62|2.71|||Mixed Models Analysis|||Month 18||2.71|-8.62|0.6608
91780980|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|6.7||0.2319|TWO_SIDED|60.0|2.37|13.66|||Mixed Models Analysis|||Month 24||13.66|2.37|0.2319
91587554|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.5||||0.23|TWO_SIDED|95.0|-1.26|0.31|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.26|0.230
91587555|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.694|TWO_SIDED|95.0|-0.63|0.94|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.94|-0.63|0.694
91587556|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.14|TWO_SIDED|95.0|-1.48|0.21|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-1.48|0.140
91587557|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.503
91587558|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.262|TWO_SIDED|95.0|-1.28|0.35|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-1.28|0.262
91587559|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.871|TWO_SIDED|95.0|-0.88|0.75|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.75|-0.88|0.871
91587560|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.373|TWO_SIDED|95.0|-1.27|0.48|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.48|-1.27|0.373
91587561|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.413
91780981|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|7.04||0.3554|TWO_SIDED|60.0|-12.43|-0.58|||Mixed Models Analysis|||Month 24||-0.58|-12.43|0.3554
91780982|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|STANDARD_ERROR_OF_MEAN|7.27||0.0113|TWO_SIDED|60.0|12.33|24.57|||Mixed Models Analysis|||Month 30||24.57|12.33|0.0113
91780983|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66|STANDARD_ERROR_OF_MEAN|7.99||0.479|TWO_SIDED|60.0|-1.07|12.39|||Mixed Models Analysis|||Month 30||12.39|-1.07|0.4790
91780984|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.46|STANDARD_ERROR_OF_MEAN|7.75||0.1776|TWO_SIDED|60.0|3.93|16.99|||Mixed Models Analysis|||Month 36||16.99|3.93|0.1776
91587562|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.317|TWO_SIDED|95.0|-1.22|0.4|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-1.22|0.317
91587563|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.708|TWO_SIDED|95.0|-0.66|0.97|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.97|-0.66|0.708
91587564|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.202|TWO_SIDED|95.0|-1.44|0.31|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.44|0.202
91587565|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.190
91587566|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.094|TWO_SIDED|95.0|-1.44|0.11|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.11|-1.44|0.094
91587567|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.96|TWO_SIDED|95.0|-0.8|0.76|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.76|-0.80|0.960
91587568|NCT01794923|183064082|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.132|TWO_SIDED|95.0|-1.48|0.2|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-1.48|0.132
91647687|NCT00883129|183187288|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the TLC %-predicted.||||>0.05
91780985|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|STANDARD_ERROR_OF_MEAN|9.5||0.7307|TWO_SIDED|60.0|-11.27|4.73|||Mixed Models Analysis|||Month 36||4.73|-11.27|0.7307
91587569|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.163
91647688|NCT00883129|183187289|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the DLCO %-predicted.||||<0.001
91780986|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.53|STANDARD_ERROR_OF_MEAN|8.25||0.1625|TWO_SIDED|60.0|4.59|18.48|||Mixed Models Analysis|||Month 42||18.48|4.59|0.1625
91780987|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.77|STANDARD_ERROR_OF_MEAN|10.12||0.2876|TWO_SIDED|60.0|2.25|19.29|||Mixed Models Analysis|||Month 42||19.29|2.25|0.2876
91780988|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|STANDARD_ERROR_OF_MEAN|8.41||0.027|TWO_SIDED|60.0|11.54|25.7|||Mixed Models Analysis|||Month 48||25.70|11.54|0.0270
91780989|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|10.54||0.7444|TWO_SIDED|60.0|-12.31|5.44|||Mixed Models Analysis|||Month 48||5.44|-12.31|0.7444
91780990|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.18|STANDARD_ERROR_OF_MEAN|8.44||0.0122|TWO_SIDED|60.0|14.08|28.29|||Mixed Models Analysis|||Month 54||28.29|14.08|0.0122
91587570|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.162|TWO_SIDED|95.0|-1.86|11.02|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.02|-1.86|0.162
91587571|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.9||||0.559|TWO_SIDED|95.0|-8.42|4.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||4.57|-8.42|0.559
91587572|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.5||||0.066|TWO_SIDED|95.0|-0.44|13.45|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.45|-0.44|0.066
91780991|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|10.86||0.3288|TWO_SIDED|60.0|-19.75|-1.47|||Mixed Models Analysis|||Month 54||-1.47|-19.75|0.3288
91780992|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.34|STANDARD_ERROR_OF_MEAN|9.15||0.0453|TWO_SIDED|60.0|10.63|26.05|||Mixed Models Analysis|||Month 60||26.05|10.63|0.0453
91780993|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|STANDARD_ERROR_OF_MEAN|11.28||0.5016|TWO_SIDED|60.0|-17.09|1.91|||Mixed Models Analysis|||Month 60||1.91|-17.09|0.5016
91780994|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.43|STANDARD_ERROR_OF_MEAN|9.69||0.0453|TWO_SIDED|60.0|11.27|27.59|||Mixed Models Analysis|||Month 66||27.59|11.27|0.0453
91780995|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_ERROR_OF_MEAN|11.84||0.8747|TWO_SIDED|60.0|-11.83|8.1|||Mixed Models Analysis|||Month 66||8.10|-11.83|0.8747
91780996|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98|STANDARD_ERROR_OF_MEAN|10.34||0.4997|TWO_SIDED|60.0|-1.72|15.69|||Mixed Models Analysis|||Month 72||15.69|-1.72|0.4997
91780997|NCT00658359|183441776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|12.1||0.2804|TWO_SIDED|60.0|-23.26|-2.88|||Mixed Models Analysis|||Month 72||-2.88|-23.26|0.2804
91780998|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|60.0|7.68|11.9|||Mixed Models Analysis|||Month 15||11.90|7.68|<0.0001
91647689|NCT00883129|183187289|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the DLCO %-predicted for each treatment arm independently.||||>0.05
91647690|NCT00883129|183187290|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the Quantitative Lung Fibrosis Score for the whole lung (QLF-WL).||||>0.05
91647691|NCT00883129|183187291|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in dyspnea as measured by the Transitional Dyspnea Index Score.||||>0.05
91647692|NCT00883129|183187291|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for dyspnea using the Transitional Dyspnea Index Score for each treatment arm independently.||||<0.05
91647693|NCT00883129|183187293|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in modified Rodnan Skin Score (mRSS).||||>0.05
91587573|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.957
91587574|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1||||0.864|TWO_SIDED|95.0|-11.2|13.33|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.33|-11.20|0.864
91587575|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9||||0.883|TWO_SIDED|95.0|-13.3|11.45|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.45|-13.30|0.883
91647694|NCT00883129|183187293|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the modified Rodnan Skin Score for each treatment arm independently.||||<0.05
91647695|NCT00883129|183187293|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of the mRSS at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the mRSS.||||>0.05
91647696|NCT00883129|183187294|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.||Fisher's Exact Test was utilized to compare the number of participants with a protocol-defined adverse event of interest, SAE or death between the MMF and CYC treatment arms.||||<0.05
91587576|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.767|TWO_SIDED|95.0|-11.24|15.22|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||15.22|-11.24|0.767
91587577|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.243
91587578|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.2||||0.176|TWO_SIDED|95.0|-20.12|3.7|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||3.70|-20.12|0.176
91647697|NCT00883129|183187295|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance was a P-Value of \</=0.05.|Log Rank|||A log-rank test was utilized to assess differences between the MMF and CYC treatment arms with respect to the time to withdrawal from study drug or meeting protocol-defined criteria for treatment failure.||||0.019
91647698|NCT03273257|183187296|SUPERIORITY|||||||0.139|||||||2-sample Wilcoxon rank sum test|||The null hypothesis is that there is no difference between the treatment groups in percent change from baseline in PVR immediately before PEA.||||0.139
91647699|NCT02450760|183187325|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91587579|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.741|TWO_SIDED|95.0|-10.0|14.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||14.03|-10.00|0.741
91587580|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.2||||0.118|TWO_SIDED|95.0|-23.07|2.62|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||2.62|-23.07|0.118
91587581|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.920
91647700|NCT02450760|183187326|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
91647701|NCT02450760|183187330|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
91647702|NCT02450760|183187331|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
91647703|NCT02450760|183187332|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
91647704|NCT01246973|183187335|SUPERIORITY_OR_OTHER|||||||0.6555|TWO_SIDED||||||F-test|||||||0.6555
91780999|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.32|STANDARD_ERROR_OF_MEAN|2.61||0.0418|TWO_SIDED|60.0|3.12|7.52|||Mixed Models Analysis|||Month 15||7.52|3.12|0.0418
91781000|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|2.51||0.0002|TWO_SIDED|60.0|7.28|11.51|||Mixed Models Analysis|||Month 18||11.51|7.28|0.0002
91587582|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.685|TWO_SIDED|95.0|-24.64|16.23|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||16.23|-24.64|0.685
91587583|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.4||||0.892|TWO_SIDED|95.0|-22.04|19.19|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.19|-22.04|0.892
91587584|NCT01794923|183064083|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.8||||0.804|TWO_SIDED|95.0|-24.82|19.25|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.25|-24.82|0.804
91587585|NCT01794923|183064084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||||0.533
91587586|NCT01794923|183064084|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5||||0.266|TWO_SIDED|95.0|-0.38|1.38|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.38|-0.38|0.266
91587587|NCT01794923|183064084|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.73|TWO_SIDED|95.0|-0.74|1.05|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.05|-0.74|0.730
91587588|NCT01794923|183064084|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.479|TWO_SIDED|95.0|-0.61|1.3|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.30|-0.61|0.479
91587589|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.189
91587590|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.389|TWO_SIDED|95.0|-0.17|0.07|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.17|0.389
91587591|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.273|TWO_SIDED|95.0|-0.05|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.05|0.273
91587592|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.069|TWO_SIDED|95.0|-0.25|0.01|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.01|-0.25|0.069
91587593|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.716
91587594|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.735|TWO_SIDED|95.0|-0.15|0.11|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.15|0.735
91587595|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.414|TWO_SIDED|95.0|-0.19|0.08|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.08|-0.19|0.414
91781001|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.63||0.0437|TWO_SIDED|60.0|3.09|7.51|||Mixed Models Analysis|||Month 18||7.51|3.09|0.0437
91587596|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.652|TWO_SIDED|95.0|-0.11|0.17|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.17|-0.11|0.652
91587597|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.622
91587598|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.83|TWO_SIDED|95.0|-0.17|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.17|0.830
91587599|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.442|TWO_SIDED|95.0|-0.26|0.11|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.26|0.442
91587600|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.358|TWO_SIDED|95.0|-0.11|0.29|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.11|0.358
91587601|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.714
91587602|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.683|TWO_SIDED|95.0|-0.29|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.29|0.683
91587603|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.413|TWO_SIDED|95.0|-0.34|0.14|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.14|-0.34|0.413
91587604|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.21|0.31|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.21|0.699
91587605|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.244
91587606|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.21|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.21|0.833
91781002|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37|STANDARD_ERROR_OF_MEAN|2.56||0.0011|TWO_SIDED|60.0|6.21|10.53|||Mixed Models Analysis|||Month 24||10.53|6.21|0.0011
91781003|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|2.75||0.4565|TWO_SIDED|60.0|-0.27|4.36|||Mixed Models Analysis|||Month 24||4.36|-0.27|0.4565
91781004|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|2.8||0.0001|TWO_SIDED|60.0|8.54|13.26|||Mixed Models Analysis|||Month 30||13.26|8.54|0.0001
91781005|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|3.09||0.1654|TWO_SIDED|60.0|1.69|6.89|||Mixed Models Analysis|||Month 30||6.89|1.69|0.1654
91781006|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45|STANDARD_ERROR_OF_MEAN|2.98||0.0015|TWO_SIDED|60.0|6.95|11.96|||Mixed Models Analysis|||Month 36||11.96|6.95|0.0015
91781007|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|STANDARD_ERROR_OF_MEAN|3.69||0.2636|TWO_SIDED|60.0|1.02|7.23|||Mixed Models Analysis|||Month 36||7.23|1.02|0.2636
91781008|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|3.12||0.052|TWO_SIDED|60.0|3.45|8.71|||Mixed Models Analysis|||Month 42||8.71|3.45|0.0520
91781009|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|STANDARD_ERROR_OF_MEAN|3.95||0.176|TWO_SIDED|60.0|2.02|8.67|||Mixed Models Analysis|||Month 42||8.67|2.02|0.1760
91521250|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3343|TWO_SIDED|95.0|-0.05|0.16||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||0.16|-0.05|0.3343
91587607|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.156|TWO_SIDED|95.0|-0.41|0.07|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.41|0.156
91587608|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.128|TWO_SIDED|95.0|-0.06|0.46|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.06|0.128
91587609|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.359
91781010|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08|STANDARD_ERROR_OF_MEAN|3.2||0.0274|TWO_SIDED|60.0|4.38|9.77|||Mixed Models Analysis|||Month 48||9.77|4.38|0.0274
91781011|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|4.13||0.8018|TWO_SIDED|60.0|-4.51|2.44|||Mixed Models Analysis|||Month 48||2.44|-4.51|0.8018
91781012|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|STANDARD_ERROR_OF_MEAN|3.23||0.0819|TWO_SIDED|60.0|2.91|8.35|||Mixed Models Analysis|||Month 54||8.35|2.91|0.0819
91647705|NCT01246973|183187336|SUPERIORITY_OR_OTHER|||||||0.3504|TWO_SIDED||||||Chi-squared|||||||0.3504
91781013|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|4.26||0.6103|TWO_SIDED|60.0|-5.75|1.41|||Mixed Models Analysis|||Month 54||1.41|-5.75|0.6103
91647706|NCT02239601|183187364|OTHER||Odds Ratio (OR)|0.41||||0.053|TWO_SIDED|95.0|0.17|1.01|||Mixed Models Analysis|||||1.01|0.17|0.053
91647707|NCT04682639|183187371|OTHER||LS mean difference|-18.54||||0.0103|TWO_SIDED|95.0|-32.6|-4.49|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||-4.49|-32.60|0.0103
91647708|NCT04682639|183187371|OTHER||LS mean difference|-7.53||||0.2861|TWO_SIDED|95.0|-21.48|6.42|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||6.42|-21.48|0.2861
91647709|NCT04682639|183187372|OTHER||LS mean difference|2.38||||0.4894|TWO_SIDED|95.0|-4.43|9.19|||Linear mixed effects model|||||9.19|-4.43|0.4894
91781014|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.49||0.1168|TWO_SIDED|60.0|2.54|8.41|||Mixed Models Analysis|||Month 60||8.41|2.54|0.1168
91781015|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|4.43||0.3357|TWO_SIDED|60.0|0.54|7.99|||Mixed Models Analysis|||Month 60||7.99|0.54|0.3357
91781016|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.42|STANDARD_ERROR_OF_MEAN|3.7||0.0448|TWO_SIDED|60.0|4.31|10.54|||Mixed Models Analysis|||Month 66||10.54|4.31|0.0448
91781017|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|4.64||0.7642|TWO_SIDED|60.0|-2.51|5.29|||Mixed Models Analysis|||Month 66||5.29|-2.51|0.7642
91781018|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|STANDARD_ERROR_OF_MEAN|3.95||0.1295|TWO_SIDED|60.0|2.67|9.32|||Mixed Models Analysis|||Month 72||9.32|2.67|0.1295
91781019|NCT00658359|183441777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_ERROR_OF_MEAN|4.75||0.654|TWO_SIDED|60.0|-1.87|6.13|||Mixed Models Analysis|||Month 72||6.13|-1.87|0.6540
91781020|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.11|STANDARD_ERROR_OF_MEAN|19.53||0.7543|TWO_SIDED|60.0|-22.55|10.33|||Mixed Models Analysis|||Month 15||10.33|-22.55|0.7543
91781021|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95|STANDARD_ERROR_OF_MEAN|20.33||0.6249|TWO_SIDED|60.0|-27.07|7.17|||Mixed Models Analysis|||Month 15||7.17|-27.07|0.6249
91781022|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.66|STANDARD_ERROR_OF_MEAN|19.61||0.3415|TWO_SIDED|60.0|-35.17|-2.15|||Mixed Models Analysis|||Month 18||-2.15|-35.17|0.3415
91781023|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.86|STANDARD_ERROR_OF_MEAN|20.47||0.072|TWO_SIDED|60.0|-54.1|-19.63|||Mixed Models Analysis|||Month 18||-19.63|-54.10|0.0720
91521251|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9258|TWO_SIDED|95.0|-0.09|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||0.10|-0.09|0.9258
91647710|NCT04682639|183187372|OTHER||LS mean difference|4.7||||0.1671|TWO_SIDED|95.0|-2.0|11.41|||Linear mixed effects model|||||11.41|-2.00|0.1671
91647711|NCT04682639|183187373|OTHER||LS mean difference|-54.53||||0.0565|TWO_SIDED|95.0|-110.59|1.54|||ANCOVA|||||1.54|-110.59|0.0565
91647712|NCT04682639|183187373|OTHER||LS mean difference|-13.95||||0.6193|TWO_SIDED|95.0|-69.61|41.71|||ANCOVA|||||41.71|-69.61|0.6193
91781024|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|19.99||0.2937|TWO_SIDED|60.0|-37.83|-4.17|||Mixed Models Analysis|||Month 24||-4.17|-37.83|0.2937
91781025|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.72|STANDARD_ERROR_OF_MEAN|21.38||0.0512|TWO_SIDED|60.0|-59.72|-23.73|||Mixed Models Analysis|||Month 24||-23.73|-59.72|0.0512
91781026|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.43|STANDARD_ERROR_OF_MEAN|21.76||0.037|TWO_SIDED|60.0|-63.75|-27.11|||Mixed Models Analysis|||Month 30||-27.11|-63.75|0.0370
91781027|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|24.0||0.8701|TWO_SIDED|60.0|-24.13|16.28|||Mixed Models Analysis|||Month 30||16.28|-24.13|0.8701
91781028|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|23.15||0.2146|TWO_SIDED|60.0|-48.24|-9.25|||Mixed Models Analysis|||Month 36||-9.25|-48.24|0.2146
91781029|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.03|STANDARD_ERROR_OF_MEAN|28.58||0.462|TWO_SIDED|60.0|-45.09|3.03|||Mixed Models Analysis|||Month 36||3.03|-45.09|0.4620
91781030|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16|STANDARD_ERROR_OF_MEAN|24.28||0.8639|TWO_SIDED|60.0|-16.28|24.6|||Mixed Models Analysis|||Month 42||24.60|-16.28|0.8639
91781031|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.3|STANDARD_ERROR_OF_MEAN|30.65||0.323|TWO_SIDED|60.0|-56.11|-4.5|||Mixed Models Analysis|||Month 42||-4.50|-56.11|0.3230
91781032|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.49|STANDARD_ERROR_OF_MEAN|24.92||0.2214|TWO_SIDED|60.0|9.51|51.47|||Mixed Models Analysis|||Month 48||51.47|9.51|0.2214
91781033|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.25|STANDARD_ERROR_OF_MEAN|32.08||0.7492|TWO_SIDED|60.0|-37.26|16.75|||Mixed Models Analysis|||Month 48||16.75|-37.26|0.7492
91781034|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|25.15||0.8236|TWO_SIDED|60.0|-15.57|26.79|||Mixed Models Analysis|||Month 54||26.79|-15.57|0.8236
91781035|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.67|STANDARD_ERROR_OF_MEAN|33.1||0.6578|TWO_SIDED|60.0|-13.2|42.54|||Mixed Models Analysis|||Month 54||42.54|-13.20|0.6578
91781036|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93|STANDARD_ERROR_OF_MEAN|27.12||0.5326|TWO_SIDED|60.0|-5.9|39.76|||Mixed Models Analysis|||Month 60||39.76|-5.90|0.5326
91781037|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|34.44||0.6845|TWO_SIDED|60.0|-42.99|15.0|||Mixed Models Analysis|||Month 60||15.00|-42.99|0.6845
91781038|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35|STANDARD_ERROR_OF_MEAN|28.73||0.7713|TWO_SIDED|60.0|-15.83|32.54|||Mixed Models Analysis|||Month 66||32.54|-15.83|0.7713
91781039|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.11|STANDARD_ERROR_OF_MEAN|36.06||0.8438|TWO_SIDED|60.0|-37.47|23.26|||Mixed Models Analysis|||Month 66||23.26|-37.47|0.8438
91781040|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|STANDARD_ERROR_OF_MEAN|30.7||0.4724|TWO_SIDED|60.0|-3.78|47.91|||Mixed Models Analysis|||Month 72||47.91|-3.78|0.4724
91781041|NCT00658359|183441778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.25|STANDARD_ERROR_OF_MEAN|36.98||0.6218|TWO_SIDED|60.0|-12.89|49.38|||Mixed Models Analysis|||Month 72||49.38|-12.89|0.6218
91781042|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|7.93||0.7693|TWO_SIDED|60.0|-9.01|4.35|||Mixed Models Analysis|||Month 15||4.35|-9.01|0.7693
91781043|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.75|STANDARD_ERROR_OF_MEAN|8.28||0.7396|TWO_SIDED|60.0|-4.22|9.73|||Mixed Models Analysis|||Month 15||9.73|-4.22|0.7396
91781044|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|STANDARD_ERROR_OF_MEAN|7.92||0.3881|TWO_SIDED|60.0|-13.51|-0.17|||Mixed Models Analysis|||Month 18||-0.17|-13.51|0.3881
91521252|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6574|TWO_SIDED|95.0|-0.1|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||0.06|-0.10|0.6574
91781045|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|8.28||0.5114|TWO_SIDED|60.0|-12.42|1.53|||Mixed Models Analysis|||Month 18||1.53|-12.42|0.5114
91781046|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|8.06||0.5829|TWO_SIDED|60.0|-11.21|2.36|||Mixed Models Analysis|||Month 24||2.36|-11.21|0.5829
91781047|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76|STANDARD_ERROR_OF_MEAN|8.58||0.2559|TWO_SIDED|60.0|-16.99|-2.53|||Mixed Models Analysis|||Month 24||-2.53|-16.99|0.2559
91781048|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|8.78||0.7548|TWO_SIDED|60.0|-4.65|10.14|||Mixed Models Analysis|||Month 30||10.14|-4.65|0.7548
91781049|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|9.57||0.7998|TWO_SIDED|60.0|-5.63|10.49|||Mixed Models Analysis|||Match 30||10.49|-5.63|0.7998
91781050|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|STANDARD_ERROR_OF_MEAN|9.08||0.2531|TWO_SIDED|60.0|2.74|18.03|||Mixed Models Analysis|||Month 36||18.03|2.74|0.2531
91781051|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.14|STANDARD_ERROR_OF_MEAN|11.2||0.365|TWO_SIDED|60.0|0.72|19.57|||Mixed Models Analysis|||Month 36||19.57|0.72|0.3650
91781052|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33|STANDARD_ERROR_OF_MEAN|9.34||0.4328|TWO_SIDED|60.0|-0.53|15.19|||Mixed Models Analysis|||Month 42||15.19|-0.53|0.4328
91781053|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|11.35||0.2547|TWO_SIDED|60.0|-22.5|-3.38|||Mixed Models Analysis|||Month 42||-3.38|-22.50|0.2547
91781054|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.72|STANDARD_ERROR_OF_MEAN|9.46||0.3572|TWO_SIDED|60.0|0.75|16.69|||Mixed Models Analysis|||Month 48||16.69|0.75|0.3572
91781055|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|11.64||0.8009|TWO_SIDED|60.0|-6.86|12.74|||Mixed Models Analysis|||Month 48||12.74|-6.86|0.8009
91781056|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|9.44||0.6814|TWO_SIDED|60.0|-11.82|4.07|||Mixed Models Analysis|||Month 54||4.07|-11.82|0.6814
91781057|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.88|STANDARD_ERROR_OF_MEAN|11.93||0.2803|TWO_SIDED|60.0|2.84|22.93|||Mixed Models Analysis|||Month 54||22.93|2.84|0.2803
91781058|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|10.23||0.7613|TWO_SIDED|60.0|-11.72|5.5|||Mixed Models Analysis|||Month 60||5.50|-11.72|0.7613
91781059|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|12.35||0.8554|TWO_SIDED|60.0|-12.65|8.15|||Mixed Models Analysis|||Month 60||8.15|-12.65|0.8554
91587610|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.278|TWO_SIDED|95.0|-0.12|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.43|-0.12|0.278
91587611|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.699|TWO_SIDED|95.0|-0.33|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.22|-0.33|0.699
91587612|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.172|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.172
91587613|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.515|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.515
91587614|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.527|TWO_SIDED|95.0|-0.19|0.37|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.37|-0.19|0.527
91587615|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.545|TWO_SIDED|95.0|-0.37|0.19|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.37|0.545
91647713|NCT04682639|183187374|OTHER||Adjusted difference from placebo|21.9||||0.0007|TWO_SIDED|95.0|9.23|34.57|||Mantel Haenszel|||||34.57|9.23|0.0007
91647714|NCT04682639|183187374|OTHER||Adjusted difference from placebo|13.85||||0.0121|TWO_SIDED|95.0|3.03|24.66|||Mantel Haenszel|||||24.66|3.03|0.0121
91781060|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|10.7||0.9132|TWO_SIDED|60.0|-10.18|7.84|||Mixed Models Analysis|||Month 66||7.84|-10.18|0.9132
91781061|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|12.79||0.7465|TWO_SIDED|60.0|-6.63|14.9|||Mixed Models Analysis|||Month 66||14.90|-6.63|0.7465
91781062|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|11.34||0.8747|TWO_SIDED|60.0|-11.34|7.76|||Mixed Models Analysis|||Month 72||7.76|-11.34|0.8747
91587616|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.25|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.47|-0.12|0.250
91587617|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.568|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.568
91587618|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.381|TWO_SIDED|95.0|-0.16|0.41|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.41|-0.16|0.381
91587619|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.31|0.26|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.31|0.863
91587620|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.33|TWO_SIDED|95.0|-0.16|0.46|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.16|0.330
91587621|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.167
91587622|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.165|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.165
91647715|NCT04682639|183187375|OTHER||Adjusted difference from placebo|12.15||||0.0173|TWO_SIDED|95.0|2.15|22.16|||Mantel Haenszel|||||22.16|2.15|0.0173
91647716|NCT04682639|183187375|OTHER||Adjusted difference from placebo|8.37||||0.059|TWO_SIDED|95.0|-0.32|17.07|||Mantel Haenszel|||||17.07|-0.32|0.0590
91709045|NCT03035916|183311323|OTHER|||||||0.411|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.411
91781063|NCT00658359|183441782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.19|STANDARD_ERROR_OF_MEAN|12.96||0.5793|TWO_SIDED|60.0|-18.1|3.72|||Mixed Models Analysis|||Month 72||3.72|-18.10|0.5793
91781064|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.76|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|60.0|10.4|15.11|||Mixed Models Analysis|||Month 15||15.11|10.40|<0.0001
91781065|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|60.0|10.96|15.82|||Mixed Models Analysis|||Month 15||15.82|10.96|<0.0001
91781066|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.48|STANDARD_ERROR_OF_MEAN|3.0||0.0002|TWO_SIDED|60.0|8.95|14.0|||Mixed Models Analysis|||Month 18||14.00|8.95|0.0002
91781067|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.98|STANDARD_ERROR_OF_MEAN|3.09||0.0002|TWO_SIDED|60.0|9.37|14.59|||Mixed Models Analysis|||Month 18||14.59|9.37|0.0002
91781068|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|60.0|10.32|15.39|||Mixed Models Analysis|||Month 24||15.39|10.32|<0.0001
91781069|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.71|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|60.0|11.08|16.35|||Mixed Models Analysis|||Month 24||16.35|11.08|<0.0001
91781070|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|60.0|13.03|18.69|||Mixed Models Analysis|||Month 30||18.69|13.03|<0.0001
91781071|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.61|STANDARD_ERROR_OF_MEAN|3.56||0.0002|TWO_SIDED|60.0|10.61|16.61|||Mixed Models Analysis|||Month 30||16.61|10.61|0.0002
91587623|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.39|0.21|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.39|0.564
91587624|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.068|TWO_SIDED|95.0|-0.02|0.62|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.62|-0.02|0.068
91587625|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.131
91587626|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.119|TWO_SIDED|95.0|-0.06|0.56|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.56|-0.06|0.119
91781072|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|3.61||0.001|TWO_SIDED|60.0|9.12|15.21|||Mixed Models Analysis|||Month 36||15.21|9.12|0.0010
91781073|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.56|STANDARD_ERROR_OF_MEAN|3.98||0.0019|TWO_SIDED|60.0|9.2|15.92|||Mixed Models Analysis|||Month 36||15.92|9.20|0.0019
91781074|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|3.38||0.0004|TWO_SIDED|60.0|9.56|15.27|||Mixed Models Analysis|||Month 42||15.27|9.56|0.0004
91781075|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|3.76||0.0182|TWO_SIDED|60.0|5.81|12.16|||Mixed Models Analysis|||Month 42||12.16|5.81|0.0182
91781076|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0013|TWO_SIDED|60.0|9.22|15.58|||Mixed Models Analysis|||Month 48||15.58|9.22|0.0013
91781077|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|4.29||0.0782|TWO_SIDED|60.0|3.99|11.22|||Mixed Models Analysis|||Month 48||11.22|3.99|0.0782
91781078|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|STANDARD_ERROR_OF_MEAN|4.02||0.0007|TWO_SIDED|60.0|10.64|17.43|||Mixed Models Analysis|||Month 54||17.43|10.64|0.0007
91781079|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.23|STANDARD_ERROR_OF_MEAN|4.72||0.0322|TWO_SIDED|60.0|6.24|14.22|||Mixed Models Analysis|||Month 54||14.22|6.24|0.0322
91521253|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.852|TWO_SIDED|95.0|-0.09|0.07||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||0.07|-0.09|0.8520
91781080|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.72|STANDARD_ERROR_OF_MEAN|3.7||0.0399|TWO_SIDED|60.0|4.59|10.86|||Mixed Models Analysis|||Month 60||10.86|4.59|0.0399
91781081|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|4.28||0.3391|TWO_SIDED|60.0|0.49|7.73|||Mixed Models Analysis|||Month 60||7.73|0.49|0.3391
91781082|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.75|STANDARD_ERROR_OF_MEAN|4.23||0.0702|TWO_SIDED|60.0|4.17|11.33|||Mixed Models Analysis|||Month 66||11.33|4.17|0.0702
91781083|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|4.89||0.221|TWO_SIDED|60.0|1.89|10.15|||Mixed Models Analysis|||Month 66||10.15|1.89|0.2210
91781084|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.03|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|60.0|8.59|17.46|||Mixed Models Analysis|||Month 72||17.46|8.59|0.0150
91781085|NCT00658359|183441784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|6.13||0.4875|TWO_SIDED|60.0|-0.91|9.45|||Mixed Models Analysis|||Month 72||9.45|-0.91|0.4875
91781086|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|4.33||0.001|TWO_SIDED|60.0|10.83|18.13|||Mixed Models Analysis|||Month 15||18.13|10.83|0.0010
91781087|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.47||0.001|TWO_SIDED|60.0|11.16|18.7|||Mixed Models Analysis|||Month 15||18.70|11.16|0.0010
91781088|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|STANDARD_ERROR_OF_MEAN|4.5||0.0023|TWO_SIDED|60.0|10.16|17.76|||Mixed Models Analysis|||Month 18||17.76|10.16|0.0023
91781089|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.57|STANDARD_ERROR_OF_MEAN|4.64||0.0039|TWO_SIDED|60.0|9.65|17.48|||Mixed Models Analysis|||Month 18||17.48|9.65|0.0039
91781090|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.02|STANDARD_ERROR_OF_MEAN|4.72||0.0017|TWO_SIDED|60.0|11.04|19.0|||Mixed Models Analysis|||Month 24||19.00|11.04|0.0017
91781091|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.88||0.0026|TWO_SIDED|60.0|10.81|19.04|||Mixed Models Analysis|||Month 24||19.04|10.81|0.0026
91781092|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.54|STANDARD_ERROR_OF_MEAN|5.06||0.0003|TWO_SIDED|60.0|14.27|22.81|||Mixed Models Analysis|||Month 30||22.81|14.27|0.0003
91781093|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.45|STANDARD_ERROR_OF_MEAN|5.29||0.0022|TWO_SIDED|60.0|11.99|20.91|||Mixed Models Analysis|||Month 30||20.91|11.99|0.0022
91781094|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19|STANDARD_ERROR_OF_MEAN|5.51||0.0065|TWO_SIDED|60.0|10.55|19.84|||Mixed Models Analysis|||Month 36||19.84|10.55|0.0065
91781095|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|6.0||0.0137|TWO_SIDED|60.0|9.87|19.99|||Mixed Models Analysis|||Month 36||19.99|9.87|0.0137
91781096|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|5.12||0.0018|TWO_SIDED|60.0|11.99|20.64|||Mixed Models Analysis|||Month 42||20.64|11.99|0.0018
91781097|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.24|STANDARD_ERROR_OF_MEAN|5.65||0.0316|TWO_SIDED|60.0|7.47|17.01|||Mixed Models Analysis|||Month 42||17.01|7.47|0.0316
91781098|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.33|STANDARD_ERROR_OF_MEAN|5.64||0.0043|TWO_SIDED|60.0|11.57|21.09|||Mixed Models Analysis|||Month 48||21.09|11.57|0.0043
91781099|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|6.31||0.1226|TWO_SIDED|60.0|4.47|15.12|||Mixed Models Analysis|||Month 48||15.12|4.47|0.1226
91781100|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.97|STANDARD_ERROR_OF_MEAN|5.7||0.0034|TWO_SIDED|60.0|12.17|21.78|||Mixed Models Analysis|||Month 54||21.78|12.17|0.0034
91781101|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.79|STANDARD_ERROR_OF_MEAN|6.52||0.0724|TWO_SIDED|60.0|6.29|17.29|||Mixed Models Analysis|||Month 54||17.29|6.29|0.0724
91781102|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.03|STANDARD_ERROR_OF_MEAN|5.92||0.1782|TWO_SIDED|60.0|3.02|13.03|||Mixed Models Analysis|||Month 60||13.03|3.02|0.1782
91781103|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|6.86||0.5947|TWO_SIDED|60.0|-2.14|9.46|||Mixed Models Analysis|||Month 66||9.46|-2.14|0.5947
91781104|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.99|STANDARD_ERROR_OF_MEAN|5.68||0.081|TWO_SIDED|60.0|5.2|14.79|||Mixed Models Analysis|||Month 66||14.79|5.20|0.0810
91781105|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|6.38||0.3965|TWO_SIDED|60.0|0.04|10.81|||Mixed Models Analysis|||Month 66||10.81|0.04|0.3965
91781106|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.16|STANDARD_ERROR_OF_MEAN|6.77||0.0128|TWO_SIDED|60.0|11.44|22.88|||Mixed Models Analysis|||Month 72||22.88|11.44|0.0128
91781107|NCT00658359|183441785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|7.83||0.5487|TWO_SIDED|60.0|-1.91|11.33|||Mixed Models Analysis|||Month 72||11.33|-1.91|0.5487
91781108|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.87|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|60.0|13.46|18.29|||Mixed Models Analysis|||Month 15||18.29|13.46|<0.0001
91781109|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|60.0|11.49|16.46|||Mixed Models Analysis|||Month 15||16.46|11.49|<0.0001
91781110|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.53|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|60.0|10.71|16.34|||Mixed Models Analysis|||Month 18||16.34|10.71|<0.0001
91781111|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_ERROR_OF_MEAN|3.43||0.0009|TWO_SIDED|60.0|8.67|14.45|||Mixed Models Analysis|||Month 18||14.45|8.67|0.0009
91781112|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.63|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|60.0|12.72|18.53|||Mixed Models Analysis|||Month 24||18.53|12.72|<0.0001
91781113|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.89|STANDARD_ERROR_OF_MEAN|3.54||0.001|TWO_SIDED|60.0|8.91|14.88|||Mixed Models Analysis|||Month 24||14.88|8.91|0.0010
91781114|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.29|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|60.0|16.03|22.55|||Mixed Models Analysis|||Month 30||22.55|16.03|<0.0001
91781115|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.97||0.0082|TWO_SIDED|60.0|7.27|13.98|||Mixed Models Analysis|||Month 30||13.98|7.27|0.0082
91781116|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.72|STANDARD_ERROR_OF_MEAN|4.31||0.0008|TWO_SIDED|60.0|11.09|18.36|||Mixed Models Analysis|||Month 36||18.36|11.09|0.0008
91781117|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.43||0.0462|TWO_SIDED|60.0|5.16|12.64|||Mixed Models Analysis|||Month 36||12.64|5.16|0.0462
91781118|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7|STANDARD_ERROR_OF_MEAN|4.25||0.0007|TWO_SIDED|60.0|11.11|18.28|||Mixed Models Analysis|||Month 42||18.28|11.11|0.0007
91781119|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|4.37||0.0519|TWO_SIDED|60.0|4.87|12.24|||Mixed Models Analysis|||Month 42||12.24|4.87|0.0519
91781120|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.58|STANDARD_ERROR_OF_MEAN|4.65||0.0039|TWO_SIDED|60.0|9.66|17.5|||Mixed Models Analysis|||Month 48||17.50|9.66|0.0039
91781121|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12|STANDARD_ERROR_OF_MEAN|4.78||0.058|TWO_SIDED|60.0|5.09|13.15|||Mixed Models Analysis|||Month 48||13.15|5.09|0.0580
91781122|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.61|STANDARD_ERROR_OF_MEAN|4.74||0.0006|TWO_SIDED|60.0|12.62|20.61|||Mixed Models Analysis|||Month 54||20.61|12.62|0.0006
91781123|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.15|STANDARD_ERROR_OF_MEAN|4.87||0.0136|TWO_SIDED|60.0|8.04|16.26|||Mixed Models Analysis|||Month 54||16.26|8.04|0.0136
91781124|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|4.74||0.0053|TWO_SIDED|60.0|9.39|17.39|||Mixed Models Analysis|||Month 60||17.39|9.39|0.0053
91781125|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.77|STANDARD_ERROR_OF_MEAN|4.87||0.0736|TWO_SIDED|60.0|4.66|12.88|||Mixed Models Analysis|||Month 60||12.88|4.66|0.0736
91781126|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|STANDARD_ERROR_OF_MEAN|4.8||0.005|TWO_SIDED|60.0|9.58|17.67|||Mixed Models Analysis|||Month 66||17.67|9.58|0.0050
91781127|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.77|STANDARD_ERROR_OF_MEAN|4.93||0.0491|TWO_SIDED|60.0|5.61|13.93|||Mixed Models Analysis|||Month 66||13.93|5.61|0.0491
91647717|NCT00331773|183187404|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio \[HR\] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.|Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.64|1.14|||Log Rank||Reference arm = Conventional 3D-CRT|||1.14|0.64|<0.001
91781128|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|5.04||0.0041|TWO_SIDED|60.0|10.4|18.91|||Mixed Models Analysis|||Month 72||18.91|10.40|0.0041
91781129|NCT00658359|183441786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.59|STANDARD_ERROR_OF_MEAN|5.19||0.066|TWO_SIDED|60.0|5.22|13.97|||Mixed Models Analysis|||Month 72||13.97|5.22|0.0660
91781130|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.73||0.2393|TWO_SIDED|95.0|-5.45|1.36|||Mixed Models Analysis|||Month 24: Physical Functioning||1.36|-5.45|0.2393
91781131|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|STANDARD_ERROR_OF_MEAN|1.89||0.0595|TWO_SIDED|95.0|-7.29|0.14|||Mixed Models Analysis|||Month 24: Physical Functioning||0.14|-7.29|0.0595
91781132|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.1||0.5182|TWO_SIDED|95.0|-2.77|5.49|||Mixed Models Analysis|||Month 24: Role Physical||5.49|-2.77|0.5182
91781133|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3938|TWO_SIDED|95.0|-6.49|2.56|||Mixed Models Analysis|||Month 24: Role Physical||2.56|-6.49|0.3938
91781134|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.12||0.8932|TWO_SIDED|95.0|-3.89|4.46|||Mixed Models Analysis|||Month 24: Bodily Pain||4.46|-3.89|0.8932
91781135|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|2.33||0.9673|TWO_SIDED|95.0|-4.48|4.67|||Mixed Models Analysis|||Month 24: Bodily Pain||4.67|-4.48|0.9673
91781136|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.78||0.329|TWO_SIDED|95.0|-1.76|5.23|||Mixed Models Analysis|||Month 24: General Health||5.23|-1.76|0.3290
91781137|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|1.95||0.578|TWO_SIDED|95.0|-2.75|4.92|||Mixed Models Analysis|||Month 24: General Health||4.92|-2.75|0.5780
91781138|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.87||0.9799|TWO_SIDED|95.0|-3.72|3.62|||Mixed Models Analysis|||Month 24: Vitality||3.62|-3.72|0.9799
91781139|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.07||0.396|TWO_SIDED|95.0|-2.31|5.83|||Mixed Models Analysis|||Month 24: Vitality||5.83|-2.31|0.3960
91781140|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|1.98||0.94|TWO_SIDED|95.0|-4.05|3.75|||Mixed Models Analysis|||Month 24: Social Functioning||3.75|-4.05|0.9400
91781141|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.2||0.8583|TWO_SIDED|95.0|-3.94|4.72|||Mixed Models Analysis|||Month 24: Social Functioning||4.72|-3.94|0.8583
91781142|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.82|STANDARD_ERROR_OF_MEAN|2.31||0.0997|TWO_SIDED|95.0|-0.73|8.37|||Mixed Models Analysis|||Month 24: Role Emotional||8.37|-0.73|0.0997
91781143|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.54||0.852|TWO_SIDED|95.0|-5.47|4.52|||Mixed Models Analysis|||Month 24: Role Emotional||4.52|-5.47|0.8520
91781144|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|2.01||0.4023|TWO_SIDED|95.0|-5.64|2.27|||Mixed Models Analysis|||Month 24: Mental Health||2.27|-5.64|0.4023
91781145|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|2.22||0.1092|TWO_SIDED|95.0|-0.8|7.92|||Mixed Models Analysis|||Month 24: Mental Health||7.92|-0.80|0.1092
91781146|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1754|TWO_SIDED|95.0|-0.1|0.52|||Mixed Models Analysis|||Month 24: TR Scale Score||0.52|-0.10|0.1754
91781147|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1802|TWO_SIDED|95.0|-0.11|0.57|||Mixed Models Analysis|||Month 24: TR Scale Score||0.57|-0.11|0.1802
91781148|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.68||0.9966|TWO_SIDED|95.0|-3.31|3.29|||Mixed Models Analysis|||Month 24: Physical Component Summary||3.29|-3.31|0.9966
91781149|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.84||0.188|TWO_SIDED|95.0|-6.04|1.19|||Mixed Models Analysis|||Month 24: Physical Component Summary||1.19|-6.04|0.1880
91781150|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.92||0.6154|TWO_SIDED|95.0|-2.81|4.73|||Mixed Models Analysis|||Month 24: Mental Component Summary||4.73|-2.81|0.6154
91781151|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.12||0.1248|TWO_SIDED|95.0|-0.91|7.43|||Mixed Models Analysis|||Month 24: Mental Component Summary||7.43|-0.91|0.1248
91781152|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.03||0.4174|TWO_SIDED|95.0|-5.63|2.34|||Mixed Models Analysis|||Month 36: Physical Functioning||2.34|-5.63|0.4174
91781153|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|STANDARD_ERROR_OF_MEAN|2.6||0.3486|TWO_SIDED|95.0|-7.54|2.66|||Mixed Models Analysis|||Month 36: Physical Functioning||2.66|-7.54|0.3486
91587627|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.616|TWO_SIDED|95.0|-0.39|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.39|0.616
91587628|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.056|TWO_SIDED|95.0|-0.01|0.66|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.01|0.056
91587629|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.255
91587630|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.144|TWO_SIDED|95.0|-0.08|0.57|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.57|-0.08|0.144
91587631|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.935|TWO_SIDED|95.0|-0.34|0.31|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.34|0.935
91587632|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.153|TWO_SIDED|95.0|-0.1|0.61|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.61|-0.10|0.153
91587633|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.128
91587634|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.067|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.63|-0.02|0.067
91587635|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-0.33|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.33|-0.33|0.999
91781154|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.47||0.8335|TWO_SIDED|95.0|-4.33|5.37|||Mixed Models Analysis|||Month 36: Role Physical||5.37|-4.33|0.8335
91587636|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.088|TWO_SIDED|95.0|-0.05|0.66|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.05|0.088
91587637|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.195|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.195
91587638|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.175|TWO_SIDED|95.0|-0.12|0.67|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.67|-0.12|0.175
91587639|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.61|TWO_SIDED|95.0|-0.5|0.3|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.30|-0.50|0.610
91587640|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.083|TWO_SIDED|95.0|-0.05|0.81|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.81|-0.05|0.083
91587641|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.884|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.884
91587642|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.43|0.35|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.35|-0.43|0.833
91587643|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.62|TWO_SIDED|95.0|-0.49|0.29|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.49|0.620
91587644|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.788|TWO_SIDED|95.0|-0.36|0.48|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.48|-0.36|0.788
91587645|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.755
91587646|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.787|TWO_SIDED|95.0|-0.45|0.34|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.34|-0.45|0.787
91587647|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.56|0.25|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.25|-0.56|0.455
91587648|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.654|TWO_SIDED|95.0|-0.33|0.53|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.33|0.654
91587649|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.370
91587650|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.472|TWO_SIDED|95.0|-0.51|0.24|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.51|0.472
91587651|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.427|TWO_SIDED|95.0|-0.23|0.53|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.23|0.427
91587652|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.159|TWO_SIDED|95.0|-0.69|0.11|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.69|0.159
91781155|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.18||0.5291|TWO_SIDED|95.0|-8.24|4.24|||Mixed Models Analysis|||Month 36: Role Physical||4.24|-8.24|0.5291
91781156|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.5||0.4033|TWO_SIDED|95.0|-2.82|7.0|||Mixed Models Analysis|||Month 36: Bodily Pain||7.00|-2.82|0.4033
91781157|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|3.24||0.9078|TWO_SIDED|95.0|-6.74|5.99|||Mixed Models Analysis|||Month 36: Bodily Pain||5.99|-6.74|0.9078
91587653|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.480
91647718|NCT00331773|183187407|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.51|1.17|||Log Rank||Reference arm = Conventional 3D-CRT|||1.17|0.51|< 0.001
91647719|NCT00331773|183187408|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.95||||0.008|TWO_SIDED|95.0|0.64|1.41|||Log Rank||Reference arm = Conventional 3D-CRT|||1.41|0.64|0.008
91647720|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.85|TWO_SIDED|95.0|0.73|1.46||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.||1.46|0.73|0.85
91647721|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.72|TWO_SIDED|95.0|0.29|5.81||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||5.81|0.29|0.72
91781158|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|2.08||0.3947|TWO_SIDED|95.0|-2.31|5.86|||Mixed Models Analysis|||Month 36: General Health||5.86|-2.31|0.3947
91587654|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.238|TWO_SIDED|95.0|-0.59|0.15|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.15|-0.59|0.238
91587655|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.794|TWO_SIDED|95.0|-0.42|0.32|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.32|-0.42|0.794
91587656|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.395|TWO_SIDED|95.0|-0.57|0.23|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.57|0.395
91587657|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.400
91587658|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.176|TWO_SIDED|95.0|-0.61|0.11|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.61|0.176
91587659|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.573|TWO_SIDED|95.0|-0.47|0.26|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.47|0.573
91587660|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.466|TWO_SIDED|95.0|-0.53|0.24|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.53|0.466
91587661|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.092
91647722|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.82|1.21||2-sided|Regression, Logistic||Reference Arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.21|0.82|0.95
91647723|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.39|TWO_SIDED|95.0|0.67|2.74||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.74|0.67|0.39
91647724|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.59||||0.005|TWO_SIDED|95.0|1.22|2.06||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.06|1.22|0.005
91781159|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.66||0.7165|TWO_SIDED|95.0|-4.26|6.2|||Mixed Models Analysis|||Month 36: General Health||6.20|-4.26|0.7165
91587662|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.086|TWO_SIDED|95.0|-0.67|0.04|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.04|-0.67|0.086
91587663|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.27|0.45|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.45|-0.27|0.616
91587664|NCT01794923|183064085|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.04|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||-0.02|-0.79|0.040
91781160|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.19||0.5112|TWO_SIDED|95.0|-2.87|5.75|||Mixed Models Analysis|||Month 36: Vitality||5.75|-2.87|0.5112
91781161|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.86||0.1218|TWO_SIDED|95.0|-1.18|10.04|||Mixed Models Analysis|||Month 36: Vitality||10.04|-1.18|0.1218
91587665|NCT01794923|183064086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||||0.751
91587666|NCT01794923|183064086|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.696|TWO_SIDED|95.0|-0.28|0.2|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.20|-0.28|0.696
91587667|NCT01794923|183064086|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.76|TWO_SIDED|95.0|-0.21|0.29|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.29|-0.21|0.760
91587668|NCT01794923|183064086|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|-0.1||||0.463|TWO_SIDED|95.0|-0.36|0.16|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.16|-0.36|0.463
91587669|NCT01881750|183064090|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Effects Regression Model|||Group X Time Interaction Cohen's d||||0.42
91587670|NCT00051363|183064097|SUPERIORITY_OR_OTHER|||||||0.0074||||||"2M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).~After correction for multiple comparisons (sequential Bonferroni) P Value=0.0444 (NS)"|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M E/F Function- SWMT-OMD.||||0.0074
91647725|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.19|TWO_SIDED|95.0|0.8|2.99||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.99|0.80|0.19
91647726|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.009|TWO_SIDED|95.0|1.07|1.61||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.61|1.07|0.009
91781162|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|2.33||0.2895|TWO_SIDED|95.0|-2.11|7.05|||Mixed Models Analysis|||Month 36: Social Functioning||7.05|-2.11|0.2895
91781163|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|3.03||0.8349|TWO_SIDED|95.0|-6.58|5.32|||Mixed Models Analysis|||Month 36: Social Functioning||5.32|-6.58|0.8349
91781164|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62|STANDARD_ERROR_OF_MEAN|2.72||0.0393|TWO_SIDED|95.0|0.28|10.97|||Mixed Models Analysis|||Month 36: Role Emotional||10.97|0.28|0.0393
91781165|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|3.52||0.7266|TWO_SIDED|95.0|-5.69|8.16|||Mixed Models Analysis|||Month 36: Role Emotional||8.16|-5.69|0.7266
91781166|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|2.36||0.4916|TWO_SIDED|95.0|-3.02|6.27|||Mixed Models Analysis|||Month 36: Mental Health||6.27|-3.02|0.4916
91781167|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|3.05||0.9008|TWO_SIDED|95.0|-5.62|6.38|||Mixed Models Analysis|||Month 36: Mental Health||6.38|-5.62|0.9008
91781168|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2965|TWO_SIDED|95.0|-0.17|0.55|||Mixed Models Analysis|||Month 36: TR Scale Score||0.55|-0.17|0.2965
91781169|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.24||0.1147|TWO_SIDED|95.0|-0.09|0.84|||Mixed Models Analysis|||Month 36: TR Scale Score||0.84|-0.09|0.1147
91781170|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|1.97||0.7786|TWO_SIDED|95.0|-4.42|3.31|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.31|-4.42|0.7786
91781171|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|2.53||0.5582|TWO_SIDED|95.0|-6.45|3.49|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.49|-6.45|0.5582
91781172|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|2.25||0.0727|TWO_SIDED|95.0|-0.37|8.47|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.47|-0.37|0.0727
91781173|NCT00658359|183441787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.91||0.3264|TWO_SIDED|95.0|-2.86|8.59|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.59|-2.86|0.3264
91781174|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3093|TWO_SIDED|95.0|-0.1|0.33|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.33|-0.10|0.3093
91781175|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.3223|TWO_SIDED|95.0|-0.12|0.36|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.36|-0.12|0.3223
91781176|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.4858|TWO_SIDED|95.0|-0.14|0.3|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.30|-0.14|0.4858
91781177|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3679|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.36|-0.13|0.3679
91781178|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6416|TWO_SIDED|95.0|-0.27|0.17|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.17|-0.27|0.6416
91781179|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4241|TWO_SIDED|95.0|-0.34|0.14|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.14|-0.34|0.4241
91781180|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.12||0.2133|TWO_SIDED|95.0|-0.09|0.39|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.39|-0.09|0.2133
91781181|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1918|TWO_SIDED|95.0|-0.09|0.44|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.44|-0.09|0.1918
91781182|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.55|-0.14|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.14|-0.55|0.0010
91781183|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.59|-0.13|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.13|-0.59|0.0020
91781184|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2012|TWO_SIDED|95.0|-0.08|0.4|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.40|-0.08|0.2012
91781185|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8986|TWO_SIDED|95.0|-0.25|0.29|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.29|-0.25|0.8986
91781186|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6724|TWO_SIDED|95.0|-0.13|0.2|||Mixed Models Analysis|||Month 24 Global Score||0.20|-0.13|0.6724
91781187|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.9297|TWO_SIDED|95.0|-0.18|0.19|||Mixed Models Analysis|||Month 24 Global Score||0.19|-0.18|0.9297
91781188|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8682|TWO_SIDED|95.0|-0.28|0.23|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.23|-0.28|0.8682
91781189|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3392|TWO_SIDED|95.0|-0.18|0.53|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.53|-0.18|0.3392
91781190|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6545|TWO_SIDED|95.0|-0.2|0.32|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.32|-0.20|0.6545
91781191|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.19||0.3253|TWO_SIDED|95.0|-0.18|0.55|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.55|-0.18|0.3253
91781192|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9698|TWO_SIDED|95.0|-0.26|0.25|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.25|-0.26|0.9698
91781193|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3065|TWO_SIDED|95.0|-0.17|0.54|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.54|-0.17|0.3065
91781194|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7147|TWO_SIDED|95.0|-0.33|0.23|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.23|-0.33|0.7147
91781195|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4852|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.53|-0.25|0.4852
91781196|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.13||0.0888|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.46|0.0888
91781197|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0719|TWO_SIDED|95.0|-0.65|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.65|0.0719
91781198|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7531|TWO_SIDED|95.0|-0.24|0.33|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.33|-0.24|0.7531
91781199|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6412|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.30|-0.49|0.6412
91781200|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.9186|TWO_SIDED|95.0|-0.2|0.18|||Mixed Models Analysis|||Month 36 Global Score||0.18|-0.20|0.9186
91781201|NCT00658359|183441788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6629|TWO_SIDED|95.0|-0.21|0.33|||Mixed Models Analysis|||Month 36 Global Score||0.33|-0.21|0.6629
91781202|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|1.72||0.2826|TWO_SIDED|95.0|-5.22|1.53|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||1.53|-5.22|0.2826
91781203|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|1.97||0.5371|TWO_SIDED|95.0|-2.65|5.09|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||5.09|-2.65|0.5371
91781204|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7503|TWO_SIDED|95.0|-1.41|1.02|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||1.02|-1.41|0.7503
91781205|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.72||0.261|TWO_SIDED|95.0|-0.6|2.21|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||2.21|-0.60|0.2610
91781206|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.98||0.3656|TWO_SIDED|95.0|-1.04|2.82|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||2.82|-1.04|0.3656
91781207|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.15||0.4405|TWO_SIDED|95.0|-3.16|1.37|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||1.37|-3.16|0.4405
91781208|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4135|TWO_SIDED|95.0|-5.45|2.25|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||2.25|-5.45|0.4135
91781209|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.75||0.7272|TWO_SIDED|95.0|-4.45|6.37|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||6.37|-4.45|0.7272
91781210|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.71||0.8111|TWO_SIDED|95.0|-1.56|1.22|||Mixed Models Analysis|||Month 36 Non-Pain symptoms Converted Score||1.22|-1.56|0.8111
91781211|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.02||0.2636|TWO_SIDED|95.0|-0.86|3.13|||Mixed Models Analysis|||Month 36 Non-Pain Symptoms Converted Score||3.13|-0.86|0.2636
91781212|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.13||0.689|TWO_SIDED|95.0|-1.77|2.67|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.67|-1.77|0.6890
91781213|NCT00658359|183441789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|1.62||0.4853|TWO_SIDED|95.0|-4.31|2.05|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.05|-4.31|0.4853
91781214|NCT02858362|183441824|OTHER|Difference in least square means. All 23 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.023|||||TWO_SIDED|95.0|-0.002|0.048||||||Week 24 Change from Baseline||0.048|-0.002|
91781215|NCT02858362|183441824|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.03|0.042||||||Week 48 Change from Baseline||0.042|-0.03|
91781216|NCT02858362|183441825|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-2.611|||||TWO_SIDED|95.0|-4.324|-0.898||||||Week 24 Change from Baseline||-0.898|-4.324|
91521254|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4532|TWO_SIDED|95.0|-0.05|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.11|-0.05|0.4532
91781217|NCT02858362|183441825|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|1.166|||||TWO_SIDED|95.0|-1.103|3.435||||||Week 48 Change from Baseline||3.435|-1.103|
91781218|NCT02858362|183441826|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-1.837|||||TWO_SIDED|95.0|-3.989|0.315||||||Week 24 Change from Baseline||0.315|-3.989|
91781219|NCT02858362|183441826|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|0.096|4.324||||||Week 48 Change from Baseline||4.324|0.096|
91781220|NCT01821118|183441856|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.984|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|90.0|0.82|1.184|||||SE of mean is presented in log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.184|0.820|
91781221|NCT01821118|183441856|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.934|STANDARD_ERROR_OF_MEAN|0.075|||TWO_SIDED|90.0|0.825|1.056|||||SE of mean is presented in log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.056|0.825|
91781222|NCT01821118|183441857|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.852|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|0.735|0.989|||||SE of mean is presented on log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||0.989|0.735|
91781223|NCT01821118|183441857|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.902|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|90.0|0.788|1.031|||||SE of mean presented on log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.031|0.788|
91781224|NCT01821118|183441858|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.005|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|90.0|0.933|1.086|||||SE of mean presented on log e scale.|ROI1, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.086|0.933|
91781225|NCT01821118|183441858|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.049|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|90.0|0.99|1.114|||||SE of mean presented on log e scale.|ROI1, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.114|0.990|
91781226|NCT01821118|183441858|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.998|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|90.0|0.947|1.052|||||SE of mean presented on log e scale.|ROI2, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.052|0.947|
91781227|NCT01821118|183441858|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|90.0|0.96|1.063|||||SE of mean presented on log e scale.|ROI2, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.063|0.960|
91781228|NCT01821118|183441859|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0602|STANDARD_ERROR_OF_MEAN|0.1281|||TWO_SIDED|90.0|-0.1576|0.2781||||||ROI1, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.2781|-0.1576|
91781229|NCT01821118|183441859|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0859|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|90.0|-0.2843|0.1124||||||ROI1, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1124|-0.2843|
91781230|NCT01821118|183441859|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0488|STANDARD_ERROR_OF_MEAN|0.0902|||TWO_SIDED|90.0|-0.2018|0.1042||||||ROI2, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1042|-0.2018|
91781231|NCT01821118|183441859|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0888|STANDARD_ERROR_OF_MEAN|0.1061|||TWO_SIDED|90.0|-0.2689|0.0914||||||ROI2, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.0914|-0.2689|
91781232|NCT01821118|183441860|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0464|STANDARD_ERROR_OF_MEAN|0.0395|||TWO_SIDED|90.0|-0.0207|0.1136||||||ROI1, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1136|-0.0207|
91781233|NCT01821118|183441860|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0737|STANDARD_ERROR_OF_MEAN|0.0383|||TWO_SIDED|90.0|0.0084|0.139||||||ROI1, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1390|0.0084|
91781234|NCT01821118|183441860|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0219|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|-0.0352|0.079||||||ROI2, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0790|-0.0352|
91781235|NCT01821118|183441860|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0117|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|90.0|-0.046|0.0694||||||ROI2, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0694|-0.0460|
91781236|NCT05038982|183441879|SUPERIORITY||Mean Difference (Net)|78.26|STANDARD_ERROR_OF_MEAN|16.15|<|0.001|TWO_SIDED|95.0|38.09|118.48||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||118.48|38.09|<0.001
91781237|NCT05038982|183441879|SUPERIORITY||Mean Difference (Net)|53.66|STANDARD_ERROR_OF_MEAN|18.12||0.0142|TWO_SIDED|95.0|8.55|98.76||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||98.76|8.55|0.0142
91781238|NCT05038982|183441881|SUPERIORITY||Mean Difference (Net)|9.4|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|6.3|12.5||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||12.5|6.3|0.002
91781239|NCT05038982|183441881|SUPERIORITY||Mean Difference (Net)|6.1|STANDARD_ERROR_OF_MEAN|1.99||0.0215|TWO_SIDED|95.0|1.6|10.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||10.6|1.6|0.0215
91781240|NCT05038982|183441882|SUPERIORITY||Mean Difference (Net)|10.1|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|5.9|14.3||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||14.3|5.9|0.002
91647727|NCT00331773|183187409|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.56||||0.22|TWO_SIDED|95.0|0.76|3.18||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||3.18|0.76|0.22
91647728|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 6 months||||0.72
91647729|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 6 months||||0.056
91647730|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 6 months||||0.99
91647731|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 6 months||||0.49
91647732|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 12 months||||0.0037
91647733|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 12 months||||0.062
91647734|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 12 months||||0.94
91647735|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 12 months||||0.93
91647736|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 24 months||||0.12
91781241|NCT05038982|183441882|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.74||0.02|TWO_SIDED|95.0|0.77|8.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.6|0.77|0.02
91781242|NCT05038982|183441883|SUPERIORITY||Mean Difference (Net)|5.44|STANDARD_ERROR_OF_MEAN|1.21||0.0078|TWO_SIDED|95.0|2.7|8.18||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.18|2.70|0.0078
91647737|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 24 months||||0.81
91647738|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 24 months||||0.69
91647739|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 24 months||||0.68
91647740|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 60 months||||0.071
91647741|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 60 months||||0.047
91647742|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 60 months||||0.4
91647743|NCT00331773|183187410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 60 months||||0.91
91647744|NCT00331773|183187412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.55
91647745|NCT00331773|183187412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.29
91647746|NCT00331773|183187412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.23
91647747|NCT00331773|183187412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.028
91647748|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level = 0.05||Baseline VAS score||||0.037
91647749|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||Baseline index score||||0.12
91647750|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month VAS score||||0.70
91647751|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month index score||||0.20
91647752|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month VAS score||||0.31
91647753|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month index score||||0.19
91647754|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month VAS score||||0.86
91647755|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month index score||||0.45
91647756|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month VAS score||||0.39
91647757|NCT00331773|183187413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month index score||||0.56
91647758|NCT01430182|183187463|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 1 sided|unpaired||||||0.37
91781243|NCT05038982|183441884|SUPERIORITY||Mean Difference (Net)|12.73|STANDARD_ERROR_OF_MEAN|3.16||0.0098|TWO_SIDED|95.0|5.57|19.89||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||19.89|5.57|0.0098
91647759|NCT00775983|183187505|NON_INFERIORITY_OR_EQUIVALENCE|Power: We assumed a standard deviation of five minutes based on historical clinic data for surgical abortions during this gestational duration range, a non-inferiority margin of five minutes, and a 10% potential attrition rate to power the study for a non-inferiority hypothesis. Thirty participants in each arm gave us 95% power to conclude non-inferiority of same day Dilapan-S compared to overnight laminaria with respect to procedure time of surgical abortions between 14-18 weeks gestation.|Mean Difference (Final Values)|2.1|||||TWO_SIDED|97.5|-0.3|4.5|||t-test, 2 sided|||Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.||4.5|-0.3|
91647760|NCT02143947|183187544|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
91781244|NCT05038982|183441884|SUPERIORITY||Mean Difference (Net)|9.88|STANDARD_ERROR_OF_MEAN|3.0||0.0117|TWO_SIDED|95.0|3.1|16.66||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||16.66|3.10|0.0117
91781245|NCT05038982|183441885|SUPERIORITY||Mean Difference (Net)|10.2|STANDARD_ERROR_OF_MEAN|2.54||0.002|TWO_SIDED|95.0|4.46|15.94||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||15.94|4.46|0.002
91781246|NCT05038982|183441886|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.23||0.0078|TWO_SIDED|95.0|0.57|1.63||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||1.63|0.57|0.0078
91587671|NCT00051363|183064097|SUPERIORITY_OR_OTHER|||||||0.2254||||||6M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M E/F Function- SWMT-OMD.||||0.2254
91587672|NCT00051363|183064098|SUPERIORITY_OR_OTHER|||||||0.4538||||||DX A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for DX A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.4538
91587673|NCT00051363|183064098|SUPERIORITY_OR_OTHER|||||||0.086||||||2M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.0860
91587674|NCT00051363|183064098|SUPERIORITY_OR_OTHER|||||||0.2103||||||6M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.2103
91587675|NCT00051363|183064099|SUPERIORITY_OR_OTHER|||||||0.7936||||||DX L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for DX L/M Function- BSRT-SR.||||0.7936
91587676|NCT00051363|183064099|SUPERIORITY_OR_OTHER|||||||0.5444||||||2M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR.||||0.5444
91587677|NCT00051363|183064099|SUPERIORITY_OR_OTHER|||||||0.7569||||||6M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR.||||0.7569
91587678|NCT00051363|183064100|SUPERIORITY_OR_OTHER|||||||0.5606||||||"2M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5606
91647761|NCT02143947|183187545|SUPERIORITY_OR_OTHER||||||=|0.036|TWO_SIDED||||||Mixed Models Analysis|||||||= .036
91647762|NCT02143947|183187546|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
91647763|NCT02143947|183187547|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< .05
91781247|NCT05038982|183441887|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.055||0.0391|TWO_SIDED|95.0|0.025|0.27||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.27|0.025|0.0391
91781248|NCT05038982|183441887|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.086||0.28|TWO_SIDED|95.0|-0.08|0.31||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.31|-.080|0.28
91587679|NCT00051363|183064100|SUPERIORITY_OR_OTHER|||||||0.6487||||||"2M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.6487
91587680|NCT00051363|183064100|SUPERIORITY_OR_OTHER|||||||0.5667||||||"2M L/M Function- PN-RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5667
91587681|NCT00051363|183064100|SUPERIORITY_OR_OTHER|||||||0.3972||||||"6M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3972
91587682|NCT00051363|183064100|SUPERIORITY_OR_OTHER|||||||0.3973||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3973
91587683|NCT00051363|183064100|SUPERIORITY_OR_OTHER|||||||0.3055||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3055
91587684|NCT00051363|183064101|SUPERIORITY_OR_OTHER|||||||0.3699||||||"2M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3699
91587685|NCT00051363|183064101|SUPERIORITY_OR_OTHER|||||||0.9673||||||"2M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9673
91587686|NCT00051363|183064101|SUPERIORITY_OR_OTHER|||||||0.3426||||||"2M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3426
91587687|NCT00051363|183064101|SUPERIORITY_OR_OTHER|||||||0.3901||||||"6M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3901
91587688|NCT00051363|183064101|SUPERIORITY_OR_OTHER|||||||0.9464||||||"6M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9464
91587689|NCT00051363|183064101|SUPERIORITY_OR_OTHER|||||||0.4372||||||"6M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.4372
91587690|NCT00051363|183064102|SUPERIORITY_OR_OTHER|||||||0.9656||||||"2M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9656
91587691|NCT00051363|183064102|SUPERIORITY_OR_OTHER|||||||0.6765||||||"2M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.6765
91587692|NCT00051363|183064102|SUPERIORITY_OR_OTHER|||||||0.5288||||||"2M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.5288
91587693|NCT00051363|183064102|SUPERIORITY_OR_OTHER|||||||0.7807||||||"6M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.7807
91587694|NCT00051363|183064102|SUPERIORITY_OR_OTHER|||||||0.9603||||||"6M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9603
91647764|NCT02660385|183187551|SUPERIORITY||Effect Size|-0.6||||0.0002|TWO_SIDED||||||Generalized Linear Mixed Model (GLMM)|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0002
91647765|NCT02660385|183187552|SUPERIORITY|||||||0.0723||||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0723
91587695|NCT00051363|183064102|SUPERIORITY_OR_OTHER|||||||0.3075||||||"6M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3075
91587696|NCT00051363|183064103|SUPERIORITY_OR_OTHER|||||||0.4262||||||2M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.4262
91587697|NCT00051363|183064103|SUPERIORITY_OR_OTHER|||||||0.3161||||||2M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.3161
91587698|NCT00051363|183064103|SUPERIORITY_OR_OTHER|||||||0.1835||||||2M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.1835
91587699|NCT00051363|183064103|SUPERIORITY_OR_OTHER|||||||0.2462||||||6M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2462
91587700|NCT00051363|183064103|SUPERIORITY_OR_OTHER|||||||0.2069||||||6M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2069
91647766|NCT02660385|183187553|SUPERIORITY||effect size|0.42||||0.011|TWO_SIDED||||||GLMM|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0110
91647767|NCT02660385|183187554|SUPERIORITY||effect size|-0.7|||<|0.0001|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||<0.0001
91647768|NCT02660385|183187555|SUPERIORITY||effect size|-0.12||||0.4356|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4356
91647769|NCT02660385|183187556|SUPERIORITY|||||||0.0148||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0148
91647770|NCT02660385|183187557|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
91587701|NCT00051363|183064103|SUPERIORITY_OR_OTHER|||||||0.5235||||||6M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.5235
91587702|NCT00051363|183064104|SUPERIORITY_OR_OTHER|||||||0.5419||||||2M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5419
91587703|NCT00051363|183064104|SUPERIORITY_OR_OTHER|||||||0.89||||||2M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8900
91587704|NCT00051363|183064104|SUPERIORITY_OR_OTHER|||||||0.0031||||||2M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0031
91587705|NCT00051363|183064104|SUPERIORITY_OR_OTHER|||||||0.8703||||||6M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8703
91587706|NCT00051363|183064104|SUPERIORITY_OR_OTHER|||||||0.1838||||||6M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.1838
91587707|NCT00051363|183064104|SUPERIORITY_OR_OTHER|||||||0.0739||||||6M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0739
91587708|NCT00051363|183064105|SUPERIORITY_OR_OTHER|||||||0.045||||||2M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0450
91587709|NCT00051363|183064105|SUPERIORITY_OR_OTHER|||||||0.4512||||||2M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4512
91647771|NCT02660385|183187558|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
91587710|NCT00051363|183064105|SUPERIORITY_OR_OTHER|||||||0.6672||||||2M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.6672
91647772|NCT02660385|183187559|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
91647773|NCT02660385|183187560|SUPERIORITY|||||||0.6358||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.6358
91647774|NCT02660385|183187561|SUPERIORITY||effect size|0.35||||0.0318|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0318
91587711|NCT00051363|183064105|SUPERIORITY_OR_OTHER|||||||0.8197||||||6M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8197
91647775|NCT02660385|183187562|SUPERIORITY|||||||0.2722||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2722
91647776|NCT02660385|183187563|SUPERIORITY||effect size|-0.27||||0.0954|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0954
91647777|NCT02660385|183187564|SUPERIORITY|||||||0.4222||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.4222
91647778|NCT02660385|183187565|SUPERIORITY||effect size|0.09||||0.5781|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.5781
91647779|NCT02660385|183187566|SUPERIORITY|||||||0.1238||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1238
91781249|NCT05038982|183441888|SUPERIORITY||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|1.607||0.0684|TWO_SIDED|95.0|0.035|7.235||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.235|0.035|0.0684
91587712|NCT00051363|183064105|SUPERIORITY_OR_OTHER|||||||0.989||||||6M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9890
91587713|NCT00051363|183064105|SUPERIORITY_OR_OTHER|||||||0.5029||||||6M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5029
91587714|NCT00051363|183064106|SUPERIORITY_OR_OTHER|||||||0.9518||||||2M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9518
91587715|NCT00051363|183064106|SUPERIORITY_OR_OTHER|||||||0.4108||||||2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4108
91587716|NCT00051363|183064106|SUPERIORITY_OR_OTHER|||||||0.4528||||||2M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4528
91587717|NCT00051363|183064106|SUPERIORITY_OR_OTHER|||||||0.8391||||||6M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8391
91587718|NCT00051363|183064106|SUPERIORITY_OR_OTHER|||||||0.2771||||||6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.2771
91647780|NCT02660385|183187567|SUPERIORITY||effect size|-0.3||||0.0558|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0558
91781250|NCT05038982|183441888|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.13||0.375|TWO_SIDED|95.0|-3.656|1.456||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||||1.456|-3.656|0.375
91647781|NCT02660385|183187568|SUPERIORITY|||||||0.023||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0230
91647782|NCT02660385|183187569|SUPERIORITY||effect size|0.06||||0.4597|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4597
91647783|NCT02660385|183187570|SUPERIORITY|||||||0.1943||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1943
91781251|NCT05038982|183441889|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.212||0.207|TWO_SIDED|95.0|-3.44|2.04||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||2.04|-3.44|0.207
91781252|NCT05038982|183441889|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.498||0.8125|TWO_SIDED|95.0|-3.389|3.389||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||3.389|-3.389|0.8125
91781253|NCT05038982|183441890|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_ERROR_OF_MEAN|1.009||0.0039|TWO_SIDED|95.0|2.52|7.08||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.08|2.52|0.0039
91781254|NCT05038982|183441890|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|1.033||0.0547|TWO_SIDED|95.0|-0.0376|4.638||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||4.638|-0.0376|0.0547
91781255|NCT05038982|183441891|SUPERIORITY||Mean Difference (Net)|9.0||||0.0003|TWO_SIDED|95.0|6.93|11.07||Threshold of significance at 0.05.|t-test, 2 sided|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||11.07|6.93|0.0003
91781256|NCT05038982|183441892|SUPERIORITY||Mean Difference (Net)|6.429|||<|0.0001|TWO_SIDED|95.0|4.011|8.846||Threshold of significance at 0.05.|t-test, 2 sided|||||8.846|4.011|<0.0001
91781257|NCT05038982|183441894|SUPERIORITY||Median Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33||Threshold of significance set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNA sequencing (RNASeq) performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.33|-0.83|<0.0001
91781258|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.091||0.0003|TWO_SIDED|95.0|-0.56|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.18|-0.56|0.0003
91647784|NCT02660385|183187571|SUPERIORITY||effect size|-0.23||||0.0027|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0027
91647785|NCT02660385|183187572|SUPERIORITY|||||||0.0792||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0792
91647786|NCT02660385|183187573|SUPERIORITY||effect size|0.13||||0.0656|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0656
91647787|NCT02660385|183187574|SUPERIORITY|||||||0.2174||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2174
91781259|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.0952|TWO_SIDED|95.0|-0.47|0.039||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||0.039|-0.47|0.0952
91781260|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.12||0.004|TWO_SIDED|95.0|-0.64|-0.13||Threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.13|-0.64|0.004
91781261|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.81|-0.053||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at week 0.||-0.053|-0.81|0.0277
91781262|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.077|TWO_SIDED|95.0|-0.85|0.049||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at week 12.||0.049|-0.85|0.077
91781263|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0363|TWO_SIDED|95.0|-0.64|-0.024||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.024|-0.64|0.0363
91781264|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|-0.63|0.062||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.062|-0.63|0.10
91781265|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0009|TWO_SIDED|95.0|-0.89|-0.27||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.27|-0.89|0.0009
91781266|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2326|TWO_SIDED|95.0|-0.77|0.2||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.20|-0.77|0.2326
91587719|NCT00051363|183064106|SUPERIORITY_OR_OTHER|||||||0.8961||||||6M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8961
91647788|NCT02660385|183187575|SUPERIORITY||effect size|0.07||||0.7028|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7028
91647789|NCT02660385|183187576|SUPERIORITY|||||||0.0509||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0509
91647790|NCT02660385|183187577|SUPERIORITY||Mean Difference (Final Values)|275.0|STANDARD_ERROR_OF_MEAN|1525.0||0.955|TWO_SIDED|95.0|-3288.0|2739.0|||t-test, 2 sided|||||2739|-3288|0.955
91781267|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0047|TWO_SIDED|95.0|-0.85|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.18|-0.85|0.0047
91781268|NCT05038982|183441894|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.0539|TWO_SIDED|95.0|-0.83|0.0076||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.0076|-0.83|0.0539
91781269|NCT00472576|183441896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.291|STANDARD_ERROR_OF_MEAN|0.693||0.001|TWO_SIDED|95.0|0.911|3.671|||Mixed Models Analysis||Mean differences reflect groups differences at end point.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||3.671|0.911|.001
91781270|NCT00472576|183441897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|2.479||0.272|TWO_SIDED|95.0|-6.981|2.901||This test is a comparison of the MK-0657 condition to the placebo condition.|Mixed Models Analysis||The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||2.901|-6.981|.272
91781271|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
91781272|NCT04032093|183441937|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|16.1|24.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||24.7|16.1|
91781273|NCT04032093|183441937|OTHER||Geometric Mean Ratio|15.6|||||TWO_SIDED|95.0|11.9|20.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.4|11.9|
91781274|NCT04032093|183441937|OTHER||Geometric Mean Ratio|11.2|||||TWO_SIDED|95.0|8.7|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.5|8.7|
91781275|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.9|
91781276|NCT04032093|183441937|OTHER||Geometric Mean Ratio|24.2|||||TWO_SIDED|95.0|18.5|31.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||31.7|18.5|
91781277|NCT04032093|183441937|OTHER||Geometric Mean Ratio|20.4|||||TWO_SIDED|95.0|15.7|26.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||26.6|15.7|
91587720|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.654||||||DX- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.6540
91587721|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.9778||||||DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.9778
91647791|NCT02660385|183187578|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
91647792|NCT02660385|183187579|SUPERIORITY||effect size|-0.05||||0.7496|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7496
91647793|NCT02660385|183187580|SUPERIORITY||effect size|0.06||||0.3821|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.3821
91647794|NCT02660385|183187581|SUPERIORITY|||||||0.7204||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.7204
91647795|NCT05180630|183187678|OTHER|||||||0.012||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3). Comparisons were total mean scores for Open dome condition, Vented dome condition, and Custom earmolds with dynamic venting|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for streamed music, but there was no analysis between groups.||||0.012
91647796|NCT05180630|183187679|OTHER|||||||0.154||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3).|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for own voice, but there was no analysis between groups.||||0.154
91647797|NCT00709735|183187681|SUPERIORITY||Mean Difference (Final Values)|-13.0|||||TWO_SIDED|95.0|-30.0|4.0|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||4.0|-30.0|
91647798|NCT00709735|183187682|SUPERIORITY||Mean Difference (Final Values)|-12.7|||||TWO_SIDED|95.0|-27.4|1.9|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||1.9|-27.4|
91647799|NCT00190684|183187837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for systolic BP|Wilcoxon signed-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647800|NCT00190684|183187837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for diastolic BP|Wilcoxon sign-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647801|NCT00190684|183187838|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for pulse|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647802|NCT00190684|183187839|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647803|NCT00190684|183187840|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647804|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91781278|NCT04032093|183441937|OTHER||Geometric Mean Ratio|13.6|||||TWO_SIDED|95.0|10.1|18.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.4|10.1|
91587722|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.8314||||||DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.8314
91647805|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647806|NCT00190684|183187841|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||p-value is for weight 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.644
91647807|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647808|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647809|NCT00190684|183187841|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for height 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.001
91647810|NCT00190684|183187841|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for height 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.044
91647811|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91587723|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.5018||||||DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.5018
91587724|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.0052||||||2M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0052
91587725|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.2476||||||2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.2476
91587726|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.752||||||2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.7520
91587727|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.0002||||||2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
91587728|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.0022||||||6M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0022
91587729|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.763||||||6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.7630
91587730|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.517||||||6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.5170
91587731|NCT00051363|183064107|SUPERIORITY_OR_OTHER|||||||0.0002||||||6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
91587732|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.9291||||||DX- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9291
91587733|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.6152||||||DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.6152
91587734|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.704||||||DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.7040
91587735|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.9537||||||DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9537
91587736|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.0004||||||2M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0004
91587737|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.3886||||||2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.3886
91781279|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
91781280|NCT04032093|183441937|OTHER||Geometric Mean Ratio|19.8|||||TWO_SIDED|95.0|15.3|25.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||25.7|15.3|
91781281|NCT04032093|183441937|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|15.9|25.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||25.1|15.9|
91647812|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91587738|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.0236||||||2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0236
91587739|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.0005||||||2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
91587740|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.0005||||||6M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
91587741|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.3796||||||6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.3796
91587742|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.0106||||||6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0106
91587743|NCT00051363|183064108|SUPERIORITY_OR_OTHER|||||||0.001||||||6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0010
91587744|NCT04668586|183064112|SUPERIORITY||||||<|0.006|||||||Chi-squared|||||||<0.006
91587745|NCT04668586|183064113|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Adjusted for four-category stratification group.||||||0.008
91587746|NCT04668586|183064115|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91587747|NCT04668586|183064116|SUPERIORITY|||||||0.09|||||||Chi-squared, Corrected|Adjusted for four-category stratification group.||||||0.09
91587748|NCT03282240|183064132|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.08|||||TWO_SIDED|95.0|0.958|1.224||||||B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.224|0.958|
91587749|NCT03282240|183064132|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.0|||||TWO_SIDED|95.0|0.881|1.129||||||B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.129|0.881|
91587750|NCT03282240|183064132|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.83|||||TWO_SIDED|95.0|0.744|0.932||||||A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||0.932|0.744|
91587751|NCT03282240|183064132|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.95|||||TWO_SIDED|95.0|0.842|1.066||||||A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.066|0.842|
91587752|NCT03282240|183064133|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-2.41|||||TWO_SIDED|95.0|-7.66|2.7||||||B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||2.70|-7.66|
91587753|NCT03282240|183064133|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-1.75|||||TWO_SIDED|95.0|-7.04|3.53||||||B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.53|-7.04|
91587754|NCT03282240|183064133|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-0.71|||||TWO_SIDED|95.0|-4.83|3.42||||||A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.42|-4.83|
91587755|NCT03282240|183064133|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-3.27|||||TWO_SIDED|95.0|-7.37|0.86||||||A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||0.86|-7.37|
91647813|NCT00190684|183187841|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||p-value is for BMI 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.032
91647814|NCT00190684|183187841|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||p-value is for BMI 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.351
91781282|NCT04032093|183441937|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|11.9|18.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||18.9|11.9|
91781283|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
91781284|NCT04032093|183441937|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|16.9|30.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||30.1|16.9|
91781285|NCT04032093|183441937|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|17.6|28.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||28.7|17.6|
91781286|NCT04032093|183441937|OTHER||Geometric Mean Ratio|16.8|||||TWO_SIDED|95.0|12.7|22.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||22.3|12.7|
91781287|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.2|0.8|
91587756|NCT03282240|183064134|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.04|||||TWO_SIDED|95.0|1.804|2.315||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.315|1.804|
91587757|NCT03282240|183064134|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.03|||||TWO_SIDED|95.0|1.802|2.288||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.288|1.802|
91647815|NCT00190684|183187841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91587758|NCT03282240|183064136|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|29.27|||||TWO_SIDED|95.0|24.78|33.29||||||B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||33.29|24.78|
91647816|NCT00190684|183187842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for RR interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647817|NCT00190684|183187842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QRS Interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91781288|NCT04032093|183441937|OTHER||Geometric Mean Ratio|21.0|||||TWO_SIDED|95.0|16.6|26.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||26.5|16.6|
91781289|NCT04032093|183441937|OTHER||Geometric Mean Ratio|15.3|||||TWO_SIDED|95.0|11.6|20.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.1|11.6|
91781290|NCT04032093|183441937|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|8.1|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.0|8.1|
91781291|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
91587759|NCT03282240|183064136|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|20.78|||||TWO_SIDED|95.0|16.5|24.61||||||B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||24.61|16.5|
91587760|NCT02910739|183064149|OTHER|The pharmacokinetic condition to initiate Part 2 of the study would be met if the point estimate for the AUC0-∞ ratio of geometric means (participants with moderate HI / healthy matched control participants) exceeds 1.5.|Geometric least-squares mean ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.83|1.3|||||GMR = geometric least squares mean (GLSM) for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-∞; no hypothesis testing was planned for this outcome measure.||1.30|0.83|
91587761|NCT02910739|183064150|OTHER||GMR|1.07|||||TWO_SIDED|90.0|0.77|1.5|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on Cmax; no hypothesis testing was planned for this outcome measure.||1.50|0.77|
91587762|NCT02910739|183064151|OTHER||GMR|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-last; no hypothesis testing was planned for this outcome measure.||1.31|0.82|
91587763|NCT02910739|183064152|OTHER||GMR|1.01|||||TWO_SIDED|90.0|0.8|1.27|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-24hr; no hypothesis testing was planned for this outcome measure.||1.27|0.80|
91587764|NCT02910739|183064153|OTHER||GMR|1.08|||||TWO_SIDED|90.0|0.9|1.3|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on C24hr; no hypothesis testing was planned for this outcome measure.||1.30|0.90|
91587765|NCT05089656|183064270|SUPERIORITY||LS-Means difference|1.88|STANDARD_ERROR_OF_MEAN|0.69||0.0074|TWO_SIDED|95.0|0.51|3.25|||Mixed Models Analysis|||Change from baseline at End of Follow-up Period 1||3.25|0.51|0.0074
91781292|NCT04032093|183441937|OTHER||Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|20.5|34.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||34.6|20.5|
91781293|NCT04032093|183441937|OTHER||Geometric Mean Ratio|18.0|||||TWO_SIDED|95.0|13.5|24.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||24.1|13.5|
91781294|NCT04032093|183441937|OTHER||Geometric Mean Ratio|13.5|||||TWO_SIDED|95.0|10.1|18.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.0|10.1|
91781295|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
91781296|NCT04032093|183441937|OTHER||Geometric Mean Ratio|25.0|||||TWO_SIDED|95.0|19.9|31.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||31.3|19.9|
91781297|NCT04032093|183441937|OTHER||Geometric Mean Ratio|18.1|||||TWO_SIDED|95.0|14.5|22.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||22.8|14.5|
91781298|NCT04032093|183441937|OTHER||Geometric Mean Ratio|13.8|||||TWO_SIDED|95.0|10.8|17.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||17.5|10.8|
91587766|NCT05089656|183064271|SUPERIORITY||LS-Means - difference|1.44|STANDARD_ERROR_OF_MEAN|0.889||0.1097|TWO_SIDED|95.0|-0.33|3.22|||Mixed Models Analysis|||Change from baseline at End of Follow-up Period 1||3.22|-0.33|0.1097
91587767|NCT05089656|183064272|SUPERIORITY||LS-Means difference|1.52|STANDARD_ERROR_OF_MEAN|0.599||0.0122|TWO_SIDED|95.0|0.34|2.71|||Mixed Models Analysis|||Change from baseline at End of Follow-up Period 1||2.71|0.34|0.0122
91587768|NCT05089656|183064273|SUPERIORITY||LS-Means difference|1.45|STANDARD_ERROR_OF_MEAN|0.836||0.0873|TWO_SIDED|95.0|-0.22|3.12|||Mixed Models Analysis|||Change from baseline at End of Follow-up Period 1||3.12|-0.22|0.0873
91587769|NCT05089656|183064274|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0879|TWO_SIDED|95.0|0.9|4.57|||Regression, Logistic|||End of Followup Period 1 (Week 52)||4.57|0.90|0.0879
91587770|NCT05089656|183064275|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6448|TWO_SIDED|95.0|0.46|3.56|||Regression, Logistic|||End of Followup Period 1 (Week 52)||3.56|0.46|0.6448
91587771|NCT02087748|183064303|SUPERIORITY_OR_OTHER|||||||0.0324|||||||t-test, 2 sided|||||||0.0324
91587772|NCT02087748|183064304|SUPERIORITY_OR_OTHER|||||||0.3688|||||||t-test, 2 sided|||||||0.3688
91587773|NCT02087748|183064305|SUPERIORITY_OR_OTHER|||||||0.0275|||||||t-test, 2 sided|||||||0.0275
91587774|NCT03219320|183064310|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91781299|NCT04032093|183441937|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.4|0.9|
91781300|NCT04032093|183441937|OTHER||Geometric Mean Ratio|34.7|||||TWO_SIDED|95.0|27.0|44.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||44.4|27.0|
91781301|NCT04032093|183441937|OTHER||Geometric Mean Ratio|23.2|||||TWO_SIDED|95.0|18.2|29.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||29.6|18.2|
91587775|NCT03078907|183064311|OTHER||Least Square (LS) mean|13.79|STANDARD_ERROR_OF_MEAN|13.695|||TWO_SIDED|95.0|13.366|40.944|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Freedson '98||40.944|13.366|
91587776|NCT03078907|183064311|OTHER||LS means|2.31|STANDARD_ERROR_OF_MEAN|6.601|||TWO_SIDED|95.0|-10.782|15.396|||ANCOVA|||Daily time spent in MVPA (minutes), Freedson '98||15.396|-10.782|
91587777|NCT03078907|183064311|OTHER||LS mean|17.81|STANDARD_ERROR_OF_MEAN|12.008|||TWO_SIDED|95.0|-6.003|41.619|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Koster '16||41.619|-6.003|
91587778|NCT03078907|183064312|OTHER||LS mean|0.67|STANDARD_ERROR_OF_MEAN|1.204|||TWO_SIDED|95.0|-1.713|3.06|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Freedson '98||3.060|-1.713|
91587779|NCT03078907|183064312|OTHER||LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.658|||TWO_SIDED|95.0|-1.351|1.258|||ANCOVA|||Percentage of daily time spent in MVPA (%), Freedson '98||1.258|-1.351|
91647818|NCT00190684|183187842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QT Bazett Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647819|NCT00190684|183187842|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for QT Data Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.310
91587780|NCT03078907|183064312|OTHER||LS mean|1.26|STANDARD_ERROR_OF_MEAN|1.191|||TWO_SIDED|95.0|-1.104|3.618|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Koster '16||3.618|-1.104|
91587781|NCT03078907|183064313|OTHER||LS mean|20.66|STANDARD_ERROR_OF_MEAN|63.695|||TWO_SIDED|95.0|-105.632|146.958|||ANCOVA|||Volume of total daily activities (counts / minute)||146.958|-105.632|
91587782|NCT03078907|183064313|OTHER||LS means|27.52|STANDARD_ERROR_OF_MEAN|65.291|||TWO_SIDED|95.0|-101.945|156.976|||ANCOVA|||Volume of non-sedentary activity (counts/minute), Koster '16||156.976|-101.945|
91587783|NCT03078907|183064314|OTHER||LS means|58409.0|STANDARD_ERROR_OF_MEAN|64985.0|||TWO_SIDED|95.0|-70444.0|187263.0|||ANCOVA|||||187263|-70444|
91587784|NCT03078907|183064315|OTHER||LS means|201.59|STANDARD_ERROR_OF_MEAN|224.212|||TWO_SIDED|95.0|-242.977|646.163|||ANCOVA|||||646.163|-242.977|
91587785|NCT03078907|183064316|OTHER||LS means|0.07|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.366|0.51|||ANCOVA|||||0.510|-0.366|
91587786|NCT01672788|183064333|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.31|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|96.89|105.93|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.93|96.89|
91587787|NCT01672788|183064333|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.3|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.4|103.29|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||103.29|97.40|
91587788|NCT01672788|183064334|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose.|Geometric Mean Ratio|101.61|STANDARD_DEVIATION|8.8|||TWO_SIDED|90.0|97.94|105.41|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||105.41|97.94|
91587789|NCT01672788|183064334|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|98.56|STANDARD_DEVIATION|10.8|||TWO_SIDED|90.0|94.24|103.08|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.08|94.24|
91587790|NCT01672788|183064335|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.2|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|96.89|105.71|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.71|96.89|
91587791|NCT01672788|183064335|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.31|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.41|103.3|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.30|97.41|
91587792|NCT01672788|183064336|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|102.7|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|98.75|106.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||106.81|98.75|
91587793|NCT01672788|183064336|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.97|STANDARD_DEVIATION|12.3|||TWO_SIDED|90.0|95.94|106.27|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||106.27|95.94|
91587794|NCT01672788|183064337|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|99.64|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|95.39|104.09|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||104.09|95.39|
91587795|NCT01672788|183064337|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|93.82|102.15|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.15|93.82|
91587796|NCT01672788|183064338|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|101.51|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|97.95|105.21|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.21|97.95|
91587797|NCT01672788|183064338|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose .|Geometric Mean Ratio|98.57|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.5|102.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.81|94.50|
91587798|NCT02445196|183064339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.57||||0.035|TWO_SIDED||||||ANOVA|||Repeated measures ANOVAs assessed the condition by time (baseline to posttreatment) interaction effects covarying PTSD treatment. Following the ITT principle, data from all randomized participants were analyzed and multiple imputation replaced missing values. A power analysis indicated that to achieve 80% power to detect an effect size in the magnitude (i.e., d = 0.25 to .33) with alpha of .05 and a correlation between repeated measures of .5, 60 participants per condition would be needed.||||.035
91587799|NCT02445196|183064340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.87||||0.086|TWO_SIDED||||||ANOVA|||||||.086
91587800|NCT02445196|183064341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.007|TWO_SIDED||||||ANOVA|||||||.007
91587801|NCT02445196|183064342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.72||||0.005|TWO_SIDED||||||ANOVA|||||||.005
91587802|NCT02445196|183064343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.113|TWO_SIDED||||||t-test, 2 sided|||||||.113
91587803|NCT02464228|183064368|OTHER|||||||0|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.000
91587804|NCT02464228|183064368|OTHER|||||||1|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
91587805|NCT02464228|183064368|OTHER|||||||0.026|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.026
91587806|NCT02464228|183064368|OTHER|||||||1|||||||Clopper-Pearson method|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
91587807|NCT01177787|183064388|OTHER||Mean Difference (Final Values)|-0.669|STANDARD_DEVIATION|0.03||0.503|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.503
91587808|NCT01570036|183064392|OTHER|Kaplan-Meier Survival Analysis|Hazard Ratio (HR)|0.62||||0.18|TWO_SIDED|95.0|0.31|1.25|||Kaplan-Meier Survival Analysis|||||1.25|.31|0.18
91587809|NCT01570036|183064394|OTHER|||||||0.02||||||Comparison of the mean LVEF from baseline to 3 months, 6 months, and 12 months; this time period includes the therapy period of trastuzumab.|ANOVA|||||||0.02
91587810|NCT01570036|183064394|OTHER|||||||0.58||||||The mean LVEF compared at baseline to 3 months, 6 months, 12 months and 24 months; this time period includes the duration of trastuzumab therapy and 1 year after completion of trastuzumab therapy.|ANOVA|||||||0.58
91647820|NCT00190684|183187842|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||p-value is for QT Fridericia Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.632
91647821|NCT00190684|183187843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for HR.|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647822|NCT00190684|183187845|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Total Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
91647823|NCT00190684|183187845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Inattentive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91781302|NCT04032093|183441937|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.0|21.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||21.7|12.0|
91781303|NCT04032093|183441939|OTHER||Geometric Mean Ratio|10.7|||||TWO_SIDED|95.0|8.1|14.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.1|8.1|
91781304|NCT04032093|183441939|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|5.5|
91781305|NCT04032093|183441939|OTHER||Geometric Mean Ratio|15.8|||||TWO_SIDED|95.0|10.7|23.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||23.4|10.7|
91781306|NCT04032093|183441939|OTHER||Geometric Mean Ratio|5.6|||||TWO_SIDED|95.0|3.5|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.0|3.5|
91781307|NCT04032093|183441939|OTHER||Geometric Mean Ratio|6.6|||||TWO_SIDED|95.0|4.5|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||9.6|4.5|
91781308|NCT04032093|183441939|OTHER||Geometric Mean Ratio|14.9|||||TWO_SIDED|95.0|11.1|19.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||19.9|11.1|
91781309|NCT04032093|183441939|OTHER||Geometric Mean Ratio|11.0|||||TWO_SIDED|95.0|6.5|18.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.6|6.5|
91781310|NCT04032093|183441939|OTHER||Geometric Mean Ratio|19.2|||||TWO_SIDED|95.0|13.1|28.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||28.0|13.1|
91781311|NCT04032093|183441939|OTHER||Geometric Mean Ratio|6.9|||||TWO_SIDED|95.0|4.2|11.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||11.4|4.2|
91587811|NCT01570036|183064394|OTHER|||||||0.65||||||Evaluating LVEF at all time points with a linear mixed regression model, this analysis compared cardiac ejection fraction over time.|Regression, Linear|||||||0.65
91781312|NCT04032093|183441939|OTHER||Geometric Mean Ratio|7.3|||||TWO_SIDED|95.0|4.5|11.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||11.8|4.5|
91781313|NCT04032093|183441939|OTHER||Geometric Mean Ratio|10.8|||||TWO_SIDED|95.0|8.3|14.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.2|8.3|
91587812|NCT01570036|183064394|OTHER|||||||0.91||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between randomization arms.|Regression, Linear|||||||0.91
91587813|NCT01570036|183064394|OTHER|||||||0.81||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between the arms over time.|Regression, Linear|||||||0.81
91587814|NCT01570036|183064395|OTHER|||||||0.149|||||||Chi-squared|Comparison of the maximum related local toxicity experienced per patient and compared between treatment arms.||The safety group consisted of any patients who received NPS with GM-CSF or placebo with GM-CSF inoculations.||||0.149
91587815|NCT01570036|183064395|OTHER|||||||0.901|||||||Chi-squared|Comparison of the maximum related systemic toxicity experienced per patient and compared between treatment arms.||||||0.901
91587816|NCT00819286|183064399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||3 Month CT Scores (Plates vs Wires)||||0.003
91587817|NCT00819286|183064399|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||6 Month CT Scores (Plates vs Wires)||||0.01
91587818|NCT00819286|183064400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93||95.0|||||t-test, 1 sided|||Plates vs Wires||||0.93
91781314|NCT04032093|183441939|OTHER||Geometric Mean Ratio|9.7|||||TWO_SIDED|95.0|6.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|6.5|
91781315|NCT04032093|183441939|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|7.1|15.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.9|7.1|
91781316|NCT04032093|183441939|OTHER||Geometric Mean Ratio|8.2|||||TWO_SIDED|95.0|5.2|12.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||12.9|5.2|
91781317|NCT04032093|183441939|OTHER||Geometric Mean Ratio|4.8|||||TWO_SIDED|95.0|3.1|7.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||7.5|3.1|
91781318|NCT04032093|183441939|OTHER||Geometric Mean Ratio|14.0|||||TWO_SIDED|95.0|10.5|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||18.7|10.5|
91781319|NCT04032093|183441939|OTHER||Geometric Mean Ratio|11.8|||||TWO_SIDED|95.0|7.4|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.7|7.4|
91781320|NCT04032093|183441939|OTHER||Geometric Mean Ratio|11.9|||||TWO_SIDED|95.0|7.7|18.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||18.3|7.7|
91781321|NCT04032093|183441939|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.5|5.5|
91781322|NCT04032093|183441939|OTHER||Geometric Mean Ratio|5.4|||||TWO_SIDED|95.0|3.3|8.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||8.8|3.3|
91781323|NCT04032093|183441939|OTHER||Geometric Mean Ratio|9.5|||||TWO_SIDED|95.0|7.4|12.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||12.3|7.4|
91781324|NCT04032093|183441939|OTHER||Geometric Mean Ratio|8.4|||||TWO_SIDED|95.0|5.7|12.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||12.4|5.7|
91781325|NCT04032093|183441939|OTHER||Geometric Mean Ratio|9.9|||||TWO_SIDED|95.0|6.4|15.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.4|6.4|
91781326|NCT04032093|183441939|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||6.8|2.9|
91781327|NCT04032093|183441939|OTHER||Geometric Mean Ratio|4.0|||||TWO_SIDED|95.0|2.5|6.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.3|2.5|
91781328|NCT04032093|183441939|OTHER||Geometric Mean Ratio|12.4|||||TWO_SIDED|95.0|9.2|16.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||16.6|9.2|
91587819|NCT02993523|183064411|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.465|0.723||Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|Log Rank||HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|||0.723|0.465|<0.001
91587820|NCT02993523|183064412|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).||||||<0.001
91587821|NCT03694418|183064420|OTHER||Incident Rate Ratio|1.73|STANDARD_DEVIATION|0.35|<|0.05|TWO_SIDED|95.0|1.02|2.95|||Wilcoxon (Mann-Whitney)|||||2.95|1.02|<0.05
91587822|NCT01806129|183064429|SUPERIORITY||Odds Ratio (OR)|2.07|||||TWO_SIDED|90.0|1.29|3.31|||||Odds ratio represents the odds of adopting the appropriate reproductive health management for patients with intervention compared to the odds among patients without intervention. Odds ratio was calculated by GEE analysis.|||3.31|1.29|
91587823|NCT00784693|183064501|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-0.87|1.69||||||Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.||1.69|-0.87|
91587824|NCT02982187|183064521|SUPERIORITY||Odds Ratio (OR)|29.114|||<|0.001|TWO_SIDED|95.0|11.047||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1: DISKUS + HandiHaler vs ELLIPTA|||11.047|<0.001
91587825|NCT02982187|183064521|SUPERIORITY||Odds Ratio (OR)|27.744|||<|0.001|TWO_SIDED|95.0|10.512||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||10.512|<0.001
91587826|NCT02982187|183064522|SUPERIORITY||Odds Ratio (OR)|4.248||||0.029|TWO_SIDED|95.0|1.416||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.416|0.029
91587827|NCT02982187|183064522|SUPERIORITY||Odds Ratio (OR)|3.855||||0.026|TWO_SIDED|95.0|1.394||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||1.394|0.026
91587828|NCT02982187|183064523|SUPERIORITY||Odds Ratio (OR)|2.0||||0.4|TWO_SIDED|95.0|0.459||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||0.459|0.400
91587829|NCT02982187|183064523|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
91587830|NCT02982187|183064524|SUPERIORITY||Odds Ratio (OR)|24.539|||<|0.001|TWO_SIDED|95.0|9.268||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||9.268|<0.001
91587831|NCT02982187|183064524|SUPERIORITY||Odds Ratio (OR)|17.974|||<|0.001|TWO_SIDED|95.0|7.239||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||7.239|<0.001
91781329|NCT04032093|183441939|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|7.1|17.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||17.9|7.1|
91781330|NCT04032093|183441939|OTHER||Geometric Mean Ratio|10.4|||||TWO_SIDED|95.0|7.0|15.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||15.2|7.0|
91781331|NCT04032093|183441939|OTHER||Geometric Mean Ratio|5.7|||||TWO_SIDED|95.0|3.7|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||9.0|3.7|
91781332|NCT04032093|183441939|OTHER||Geometric Mean Ratio|4.3|||||TWO_SIDED|95.0|2.7|7.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||7.0|2.7|
91781333|NCT04032093|183441939|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|8.6|14.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.9|8.6|
91781334|NCT04032093|183441939|OTHER||Geometric Mean Ratio|10.2|||||TWO_SIDED|95.0|7.4|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.0|7.4|
91587832|NCT02982187|183064525|SUPERIORITY||Odds Ratio (OR)|3.237||||0.067|TWO_SIDED|95.0|1.124||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.124|0.067
91587833|NCT02982187|183064525|SUPERIORITY||Odds Ratio (OR)|6.357||||0.003|TWO_SIDED|95.0|2.219||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||2.219|0.003
91587834|NCT02982187|183064526|SUPERIORITY||||||||||||||stratified exact logistic model|||Sub study 1: DISKUS + HandiHaler vs ELLIPTA|These statistics were only presented when the model successfully converged. A stratified exact logistic model was used with participant included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|||
91587835|NCT02982187|183064526|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
91587836|NCT02982187|183064527|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 1:DISKUS + HandiHaler vs ELLIPTA||||<0.001
91587837|NCT02982187|183064527|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA||||<0.001
91587838|NCT02982187|183064531|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91587839|NCT02982187|183064531|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91587840|NCT02982187|183064532|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91587841|NCT02982187|183064532|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91587842|NCT02888665|183064534|OTHER||see above|||||||||||see above. target ORR was not met.|||see above. target ORR was not met.|The primary objective of the phase II design compared ORR with historical rates (Judson et al. Lancet Onc., 2014). A 2-stage design with null hypothesis of 15% using a 1-sided 0.05 α level test has 85% power to detect an increase to 35%. This required up to 35 patients. After 2 responses in stage 1 (20 pts), the study moved to stage 2 (15 pts). If 10 responses were seen (29%), this would have ruled out an ORR of 15%. The study was closed when it became clear we would not meet this benchmark.|see above. target ORR was not met.|||
91647824|NCT00190684|183187845|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Hyperactive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
91647825|NCT00190684|183187846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CGI ADHD Severity within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||||||<0.001
91587843|NCT02349451|183064539|SUPERIORITY||response rate difference|39.8|||<|0.001|TWO_SIDED|95.0|17.2|57.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||57.7|17.2|<0.001
91587844|NCT02349451|183064539|SUPERIORITY||response rate difference|50.3|||<|0.001|TWO_SIDED|95.0|28.1|67.4||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||67.4|28.1|<0.001
91587845|NCT02349451|183064540|SUPERIORITY||response rate difference|-3.3||||0.723|TWO_SIDED|95.0|-18.5|12.1||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||12.1|-18.5|0.723
91587846|NCT02349451|183064540|SUPERIORITY||response rate difference|7.3||||0.215|TWO_SIDED|95.0|-7.4|21.6||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||21.6|-7.4|0.215
91587847|NCT02349451|183064541|SUPERIORITY||response rate difference|24.1||||0.021|TWO_SIDED|95.0|3.9|39.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.3|3.9|0.021
91587848|NCT02349451|183064541|SUPERIORITY||response rate difference|-0.9||||0.611|TWO_SIDED|95.0|-16.5|14.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||14.8|-16.5|0.611
91587849|NCT02349451|183064541|SUPERIORITY||response rate difference|40.9|||<|0.001|TWO_SIDED|95.0|20.1|55.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||55.8|20.1|<0.001
91709046|NCT03035916|183311323|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91781335|NCT04032093|183441939|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|10.2|22.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||22.1|10.2|
91781336|NCT04032093|183441939|OTHER||Geometric Mean Ratio|6.1|||||TWO_SIDED|95.0|3.9|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.6|3.9|
91781337|NCT04032093|183441939|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.9|2.9|
91781338|NCT04032093|183441939|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.5|21.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||21.2|12.5|
91781339|NCT04032093|183441939|OTHER||Geometric Mean Ratio|12.8|||||TWO_SIDED|95.0|8.6|19.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||19.1|8.6|
91781340|NCT04032093|183441939|OTHER||Geometric Mean Ratio|17.7|||||TWO_SIDED|95.0|11.9|26.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||26.2|11.9|
91781341|NCT04032093|183441939|OTHER||Geometric Mean Ratio|9.0|||||TWO_SIDED|95.0|5.7|14.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.4|5.7|
91781342|NCT04032093|183441939|OTHER||Geometric Mean Ratio|6.2|||||TWO_SIDED|95.0|3.9|9.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||9.9|3.9|
91781343|NCT01356277|183441940|SUPERIORITY||Odds Ratio (OR)|1.66||||0.006|TWO_SIDED|95.0|1.15|2.39|||Regression, Logistic|Unadjusted, ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|We estimated a sample size of 75 participants per group to have 85% power to detect a 20% difference in taking adherence between groups, using 2-sided tests and setting alpha at 0.05, assuming a common standard deviation of 40%. Targeted enrollment of 176 participants accounted for 15% drop-out. Only participants with electronic pillbox data could be included. For participants who withdrew or stopped using the pillbox, all available pillbox data were included.||2.39|1.15|0.006
91587850|NCT02349451|183064541|SUPERIORITY||response rate difference|15.9||||0.039|TWO_SIDED|95.0|-0.3|31.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||31.3|-0.3|0.039
91587851|NCT02349451|183064542|SUPERIORITY||response rate difference|18.4||||0.034|TWO_SIDED|95.0|1.5|29.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||29.7|1.5|0.034
91587852|NCT02349451|183064542|SUPERIORITY||response rate difference|7.3||||0.185|TWO_SIDED|95.0|-5.8|19.9||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||19.9|-5.8|0.185
91587853|NCT02349451|183064542|SUPERIORITY||response rate difference|27.3||||0.004|TWO_SIDED|95.0|9.6|39.0||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.0|9.6|0.004
91781344|NCT01356277|183441941|SUPERIORITY||Odds Ratio (OR)|1.74||||0.003|TWO_SIDED|95.0|1.21|2.5|||Regression, Logistic|Unadjusted ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|||2.50|1.21|0.003
91781345|NCT01356277|183441942|SUPERIORITY|||||||0.49|||||||Wilcoxon ranksum|||Null hypothesis was that there was no difference in the SD of tacrolimus trough levels between intervention and control.||||0.49
91781346|NCT01356277|183441943|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91781347|NCT01356277|183441944|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91587854|NCT02349451|183064542|SUPERIORITY||response rate difference|16.2||||0.017|TWO_SIDED|95.0|2.3|29.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||29.3|2.3|0.017
91587855|NCT02349451|183064543|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
91781348|NCT01356277|183441945|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates were compared between intervention and control groups using Chi square||||0.26
91781349|NCT01356277|183441946|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
91587856|NCT02349451|183064543|SUPERIORITY|||||||0.561||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.561
91587857|NCT02349451|183064543|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
91587858|NCT02349451|183064543|SUPERIORITY|||||||0.106||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.106
91587859|NCT02349451|183064544|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.58|-0.57||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.57|-1.58|<0.001
91587860|NCT02349451|183064544|SUPERIORITY||Least squares mean difference|-0.13||||0.479|TWO_SIDED|95.0|-0.48|0.23||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.23|-0.48|0.479
91587861|NCT02349451|183064544|SUPERIORITY||Least squares mean difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.9|-0.89||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.89|-1.90|<0.001
91587862|NCT02349451|183064544|SUPERIORITY||Least squares mean difference|-0.45||||0.012|TWO_SIDED|95.0|-0.81|-0.1||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.10|-0.81|0.012
91587863|NCT02349451|183064545|SUPERIORITY||Least squares mean difference|-1.17|||<|0.001|TWO_SIDED|95.0|-1.81|-0.53||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.53|-1.81|<0.001
91587864|NCT02349451|183064545|SUPERIORITY||Least squares mean difference|-0.09||||0.696|TWO_SIDED|95.0|-0.54|0.36||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.36|-0.54|0.696
91587865|NCT02349451|183064545|SUPERIORITY||Least squares mean difference|-1.41|||<|0.001|TWO_SIDED|95.0|-2.04|-0.77||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.77|-2.04|<0.001
91587866|NCT02349451|183064545|SUPERIORITY||Least squares mean difference|-0.33||||0.151|TWO_SIDED|95.0|-0.77|0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.12|-0.77|0.151
91587867|NCT02349451|183064546|SUPERIORITY||Least squares mean difference|-3.17|||<|0.001|TWO_SIDED|95.0|-4.14|-2.19||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-2.19|-4.14|<0.001
91587868|NCT02349451|183064546|SUPERIORITY||Least squares mean difference|-0.81||||0.021|TWO_SIDED|95.0|-1.51|-0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.12|-1.51|0.021
91587869|NCT02349451|183064546|SUPERIORITY||Least squares mean difference|-2.73|||<|0.001|TWO_SIDED|95.0|-3.7|-1.75||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-1.75|-3.70|<0.001
91587870|NCT02349451|183064546|SUPERIORITY||Least squares mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.32|-1.06|0.288
91587871|NCT02168842|183064563|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.79||||0.073|TWO_SIDED|95.0|0.61|1.03|||Log Rank|||||1.03|0.61|0.073
91587872|NCT02168842|183064564|EQUIVALENCE|Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.|Hazard Ratio (HR)|1.53||||0.21|TWO_SIDED|95.0|0.78|3.01|||Log Rank|||||3.01|0.78|0.21
91587873|NCT02168842|183064565|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.83||||0.35|TWO_SIDED|95.0|0.56|1.22|||Log Rank|||||1.22|0.56|0.35
91587874|NCT00186069|183064600|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.68|TWO_SIDED|95.0|0.77|1.86|||Fisher Exact|||||1.86|0.77|0.68
91587875|NCT00186069|183064601|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
91587876|NCT00186069|183064602|SUPERIORITY_OR_OTHER|||||||0.95|||||||Fisher Exact|||||||0.95
91587877|NCT00696761|183064615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91587878|NCT00696761|183064616|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Kruskal-Wallis|||The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.||||<0.05
91587879|NCT03318809|183064669|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and confidence interval (CI) are based on natural log scale data converted back to the original scale.|||2.10|0.73|
91587880|NCT03318809|183064670|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.41|||||TWO_SIDED|90.0|0.88|2.27|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.27|0.88|
91587881|NCT03318809|183064673|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.10|0.73|
91587882|NCT00752622|183064766|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to evaluation Week 10.||||<.0001
91587883|NCT00752622|183064766|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 30 of the Observational Phase.||||<.0001
91587884|NCT00752622|183064766|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 54 of the Observational Phase.||||<.0001
91587885|NCT00178126|183064846|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
91587886|NCT01323634|183064848|SUPERIORITY_OR_OTHER||Least square mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.037|0.124|||ANCOVA|||||0.124|0.037|<0.001
91587887|NCT01182194|183064851|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.5|||||TWO_SIDED|90.0|85.53|100.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.03|85.53|
91587888|NCT01182194|183064852|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.76|||||TWO_SIDED|90.0|95.66|101.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.96|95.66|
91613917|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
91781350|NCT02141204|183441994|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% confidence interval (CI) for the ratio of anti-RV IgA antibody GMCs between HRV Liq Group over the HRV Lyo Group should be greater than or equal to (≥) 0.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.65|1.34|||ANCOVA|95% CI for the adjusted GMC ratio and the logarithm of baseline concentration were used as fixed effects in this ANCOVA model.||Anti-RV IgA GMCs (non-inferiority): Non-inferiority comparison between GSK Biologicals' HRV liquid vaccine (HRV Liq Group) and GSK Biologicals' HRV lyophilized vaccine (HRV Lyo Group) in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month after the administration of the second dose of study vaccine.||1.34|0.65|
91781351|NCT01209325|183442005|SUPERIORITY|||||||0.112||||||Two-sided p-value|Exact poisson test|||||||0.112
91781352|NCT01209325|183442005|SUPERIORITY|||||||0.447||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.||||0.447
91781353|NCT01209325|183442006|SUPERIORITY|||||||0.224||||||Two-sided p-value.|Exact poisson test|||||||0.224
91587889|NCT01182194|183064853|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.47|||||TWO_SIDED|90.0|95.35|101.7|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.70|95.35|
91587890|NCT01182194|183064854|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.45|||||TWO_SIDED|90.0|94.36|109.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.08|94.36|
91587891|NCT01182194|183064855|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.54|||||TWO_SIDED|90.0|94.55|102.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.71|94.55|
91647826|NCT00190684|183187847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS ADHD Index Subscale within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91647827|NCT00190684|183187847|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for CPRS Cognitive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
91781354|NCT01209325|183442006|SUPERIORITY|One-sided p-value.||||||0.361|||||||Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.||||0.361
91647828|NCT00190684|183187847|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||p-value is for CPRS Hyperactive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.026
91781355|NCT01209325|183442007|SUPERIORITY|||||||0.079||||||Two-sided p-value.|Exact poisson test|||||||0.079
91781356|NCT01209325|183442007|SUPERIORITY|||||||0.35||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.||||0.350
91781357|NCT01209325|183442008|SUPERIORITY|||||||0.162|||||||Exact poisson test|||||||0.162
91781358|NCT01209325|183442008|SUPERIORITY|||||||0.49||||||One-sided p-value|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.||||0.490
91781359|NCT01209325|183442009|SUPERIORITY|||||||0.671||||||Two-sided p-value is comparing naive and prior exposure groups for HPV 6.|Exact Poisson calculation|||||||0.671
91781360|NCT01209325|183442009|SUPERIORITY|||||||0.312||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.||||0.312
91781361|NCT01209325|183442010|SUPERIORITY||||||>|0.999||||||Two-sided p-value.|Exact Poisson calculation|||||||>0.999
91781362|NCT01209325|183442010|SUPERIORITY|||||||0.209||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.||||0.209
91781363|NCT01209325|183442011|SUPERIORITY|||||||0.386||||||Two-sided p-value.|Exact Poisson calculation|||||||0.386
91781364|NCT01209325|183442011|SUPERIORITY|||||||0.305||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.||||0.305
91781365|NCT01209325|183442012|SUPERIORITY|||||||0.622||||||Two-sided p-value.|Exact Poisson calculation|||||||0.622
91587892|NCT01182194|183064856|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|96.07|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.46|96.07|
91647829|NCT00190684|183187847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS Oppositional Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
91781366|NCT01209325|183442012|SUPERIORITY|||||||0.15||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.||||0.150
91781367|NCT01209325|183442013|SUPERIORITY|||||||0.064||||||Two-sided p-value.|Exact Poisson calculation|||||||0.064
91781368|NCT01209325|183442014|SUPERIORITY|||||||0.745||||||Two-sided test.|Exact Poisson calculation|||||||0.745
91781369|NCT01209325|183442015|SUPERIORITY|||||||0.014|||||||Exact Poisson calculation|||||||0.014
91781370|NCT01209325|183442016|SUPERIORITY|||||||0.166||||||Two-sided p-value.|Exact Poisson calculation|||||||0.166
91781371|NCT01209325|183442017|SUPERIORITY|||||||0.789||||||Two-sided p-value.|Exact Poisson calculation|||||||0.789
91781372|NCT01209325|183442018|SUPERIORITY|||||||0.809||||||Two-sided p-value.|0.809|||||||0.809
91781373|NCT01209325|183442019|SUPERIORITY|||||||0.422||||||Two-sided p-value.|Exact Poisson calculation|||||||0.422
91781374|NCT01209325|183442020|SUPERIORITY|||||||0.423||||||Two-sided p-value.|Exact Poisson calculation|||||||0.423
91781375|NCT01285557|183442060|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9312|TWO_SIDED|95.0|0.76|1.28|||Unstratified Log-rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the unstratified log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.28|0.76|0.9312
91781376|NCT01285557|183442061|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3039|TWO_SIDED|95.0|0.65|1.14|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.14|0.65|0.3039
91781377|NCT01285557|183442062|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1683|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.08|0.66|0.1683
91781378|NCT02000115|183442081|NON_INFERIORITY|8.0% non-inferiority margin|Difference in percentages between groups|1.5||||0.006|ONE_SIDED|95.0||5.7||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·0%)|We analysed the primary effectiveness endpoint in the intention-to- treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||5.7||0.006
91781379|NCT02000115|183442082|NON_INFERIORITY|8.5% non-inferiority margin|Difference in percentages between groups|4.2||||0.03|ONE_SIDED|95.0||8.1||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·5%)|We analysed the primary safety endpoint in the intention-to-treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||8.1||0.03
91781380|NCT02000115|183442084|NON_INFERIORITY|non-inferiority margin of 4%|Difference in percentages between groups|0.4||||0.001|ONE_SIDED|95.0||2.3||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions.|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 4%, then non inferiority is demonstrated.|||2.3||0.001
91647830|NCT02354976|183187869|OTHER||Geometric mean ratio for difference|0.92||||0.407|TWO_SIDED|95.0|0.76|1.12|||Mixed Models Analysis|||||1.12|0.76|0.407
91781381|NCT02000115|183442085|NON_INFERIORITY|non-inferiority margin of 10 points|Mean Difference (Final Values)|-0.5|||<|0.0001|ONE_SIDED|95.0|-3.5|||p for non-inferiority|two-sample t-test|The test statistic is based on two sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -10, then non inferiority is demonstrated.||||-3.5|<0.0001
91781382|NCT02000115|183442086|NON_INFERIORITY|non-inferiority margin of 6%|Difference in percentages between groups|5.6||||0.4|ONE_SIDED|95.0||8.5||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 6%, then non inferiority is demonstrated.|||8.5||0.40
91781383|NCT02000115|183442087|NON_INFERIORITY|non-inferiority margin on -36 meters|Mean Difference (Final Values)|3.5||||0.0003|ONE_SIDED|95.0|-15.4|||p for non-inferiority|two sample t-test|The test statistic is based on a two-sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -36, then non inferiority is demonstrated.||||-15.4|0.0003
91781384|NCT04922216|183442098|SUPERIORITY||Mean Difference (Net)|0.3||||0.52|TWO_SIDED|95.0|-0.61|1.2|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 6 months).||1.20|-0.61|0.52
91781385|NCT04922216|183442098|SUPERIORITY||Mean Difference (Net)|-0.28||||0.54|TWO_SIDED|95.0|-1.19|0.63|||Mixed Models Analysis|Degrees of freedom (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||0.63|-1.19|0.54
91781386|NCT04922216|183442098|SUPERIORITY||Mean Difference (Net)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.31|||Mixed Models Analysis|Degrees of freedom (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||1.31|-0.50|0.39
91781387|NCT04922216|183442098|SUPERIORITY||Mean Difference (Net)|0.39||||0.7|TWO_SIDED|95.0|-0.52|1.3|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 6 months).||1.30|-0.52|0.70
91781388|NCT04922216|183442098|SUPERIORITY||Mean Difference (Net)|-0.55||||0.47|TWO_SIDED|95.0|-1.45|0.36|||Mixed Models Analysis|Degrees of freedom (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 6 months).||0.36|-1.45|0.47
91781389|NCT04922216|183442099|SUPERIORITY||Mean Difference (Net)|0.24||||0.43|TWO_SIDED|95.0|-0.36|0.84|||Mixed Models Analysis|DF (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 3 months).||0.84|-0.36|0.43
91781390|NCT04922216|183442099|SUPERIORITY||Mean Difference (Net)|-0.42||||0.17|TWO_SIDED|95.0|-1.01|0.18|||Mixed Models Analysis|DF (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||0.18|-1.01|0.17
91781391|NCT04922216|183442099|SUPERIORITY||Mean Difference (Net)|0.53||||0.08|TWO_SIDED|95.0|-0.06|1.13|||Mixed Models Analysis|DF (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||1.13|-0.06|0.08
91781392|NCT04922216|183442099|SUPERIORITY||Mean Difference (Net)|0.32||||0.58|TWO_SIDED|95.0|-0.28|0.91|||Mixed Models Analysis|DF (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 3 months).||0.91|-0.28|0.58
91647831|NCT02354976|183187870|OTHER||Geometric mean ratio for difference|0.84||||0.077|TWO_SIDED|95.0|0.7|1.02|||Mixed Models Analysis|||||1.02|0.70|0.077
91647832|NCT00068445|183187873|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
91647833|NCT00068445|183187874|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91647834|NCT00068445|183187875|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91781393|NCT04922216|183442099|SUPERIORITY||Mean Difference (Net)|-0.32||||0.55|TWO_SIDED|95.0|-0.91|0.28|||Mixed Models Analysis|DF (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 3 months).||0.28|-0.91|0.55
91647835|NCT00068445|183187876|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
91647836|NCT00068445|183187877|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91647837|NCT00068445|183187878|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91647838|NCT00068445|183187879|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91647839|NCT00068445|183187880|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91647840|NCT00068445|183187881|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91647841|NCT00068445|183187882|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91647842|NCT01155284|183187883|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|||||The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.|ANCOVA|||||||0.81
91647843|NCT01155284|183187884|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||ANCOVA|||||||0.869
91521255|NCT02954354|182917046|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.157|TWO_SIDED|95.0|-0.02|0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||120 hours||0.13|-0.02|0.1570
91587893|NCT01585987|183064860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.439||||0.0972|TWO_SIDED|80.0|1.085|1.908||Significance level used: 0.2|Log Rank||The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model|||1.908|1.085|0.0972
91587894|NCT01585987|183064861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.588||||0.0336|TWO_SIDED|80.0|1.199|2.103||Significance level used: 0.2|Log Rank|||||2.103|1.199|0.0336
91587895|NCT01585987|183064862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.6433|TWO_SIDED|80.0|0.602|1.269||Significance level used: 0.2|Log Rank||HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.|||1.269|0.602|0.6433
91587896|NCT01585987|183064864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0549||||0.3686|TWO_SIDED|80.0|0.7009|47.6447||Significance level used: 0.2|Cochran-Mantel-Haenszel|||||47.6447|0.7009|0.3686
91587897|NCT03291587|183064865|SUPERIORITY|With 418 analyzable participants across 13 clinics per group, we have 80% power to detect a group difference in primary outcome (7-day abstinence). This assumes control abstinence rate will be 10% versus 20% intervention rate using a 2-sided Z-test for proportions with alpha=0.05 (2-sided). To account for the clustering we used an intra-class correlation value of 0.03. We plan to enroll 1114-1300 patients (or approximately 42-50 per site) to conservatively allow for 25%- 35.5% loss to follow-up.|Odds Ratio (OR)|0.967||||0.865|TWO_SIDED|96.0|0.652|1.433|||Mixed Models Analysis|||A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.||1.433|0.652|0.865
91587898|NCT02197767|183064874|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
91587899|NCT02197767|183064875|SUPERIORITY|||||||0.068|||||||t-test, 2 sided|||||||0.068
91587900|NCT03662139|183064917|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
91587901|NCT03662139|183064917|SUPERIORITY||ICC|0.97|||<|0.05|TWO_SIDED|95.0|0.915|0.99|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)||0.99|0.915|<0.05
91587902|NCT03662139|183064917|SUPERIORITY||ICC|0.983|||<|0.01|TWO_SIDED|95.0|0.882|0.998|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)||0.998|0.882|<0.01
91587903|NCT03662139|183064918|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
91587904|NCT03662139|183064918|SUPERIORITY||Spearman's correlation coefficient (rs)|0.724|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test|The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.||Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy group||||<0.05
91587905|NCT03662139|183064919|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
91587906|NCT03662139|183064919|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.828|||<|0.01|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy group||||<0.01
91587907|NCT03662139|183064920|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
91587908|NCT03662139|183064920|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.673|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.||||<0.05
91587909|NCT04658186|183064983|SUPERIORITY||Difference in RMET|0.31||||0.647|TWO_SIDED|95.0|-1.0|1.61|||Wald Chi-square||Results were obtained from a generalized linear model for the restricted mean event time (RMET), with gender and age at baseline as covariates and treatment group as the effect of interest.|||1.61|-1.00|0.647
91587910|NCT04658186|183064983|SUPERIORITY||Difference in RMET|0.81||||0.214|TWO_SIDED|95.0|-0.47|2.09|||Wald Chi-square||Results obtained from generalized linear model for RMET, with gender and age at baseline as covariates and treatment group as effect of interest.|||2.09|-0.47|0.214
91587911|NCT04658186|183064986|SUPERIORITY||Difference in RMET|1.0||||0.124|TWO_SIDED|95.0|-0.27|2.27|||Wald Chi-square||Results were obtained from a generalized linear model for the RMET, with gender and age at baseline as covariates and treatment group as the effect of interest.|||2.27|-0.27|0.124
91587912|NCT04658186|183064986|SUPERIORITY||Difference in RMET|1.22||||0.064||95.0|-0.07|2.51|||Wald Chi-sqaure||Results were obtained from a generalized linear model for the RMET, with gender and age at baseline as covariates and treatment group as the effect of interest.|||2.51|-0.07|0.064
91613918|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.0009|TWO_SIDED|95.0|1.232|2.235|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.235|1.232|0.0009
91613919|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.255||||0.0045|TWO_SIDED|95.0|1.073|1.467|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.467|1.073|0.0045
91781394|NCT04922216|183442100|SUPERIORITY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.7|1.39|||Chi-squared|DF (1)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard dietary monitoring and simplified dietary monitoring (factor 1).||1.39|0.70|0.95
91781395|NCT04922216|183442100|SUPERIORITY||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.03|2.05|||Chi-squared|DF (1)|Weekly adaptive activity goals coded as 0 (reference) and daily adaptive activity goals coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between weekly adaptive activity goals and daily adaptive activity goals (factor 2).||2.05|1.03|0.03
91781396|NCT04922216|183442100|SUPERIORITY||Odds Ratio (OR)|0.85||||0.36|TWO_SIDED|95.0|0.6|1.2|||Chi-squared|DF (1)|Fixed decision points coded as 0 (reference) and adaptive decision points coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between fixed message decision points and adaptive message decision points (factor 3).||1.20|0.60|0.36
91781397|NCT04922216|183442100|SUPERIORITY||Odds Ratio (OR)|1.01||||0.95|TWO_SIDED|95.0|0.72|1.42|||Chi-squared|DF (1)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard message decision rules and adaptive message decision rules (factor 4).||1.42|0.72|0.95
91781398|NCT04922216|183442100|SUPERIORITY||Odds Ratio (OR)|1.2||||0.29|TWO_SIDED|95.0|0.85|1.69|||Chi-squared|DF (1)|No message choice coded as 0 (reference) and message choice coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between no message choice and message choice (factor 5).||1.69|0.85|0.29
91781399|NCT01136980|183442122|SUPERIORITY||||||<|0.028|||||||Chi-squared|||||||<0.028
91781400|NCT02605122|183442137|OTHER||Proportion experiencing TEAE or TESAE|34.3|||||TWO_SIDED|95.0|23.0|47.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||47|23|
91781401|NCT02605122|183442138|OTHER||Achievement of ECR|62.1|||||TWO_SIDED|95.0|49.0|74.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||74|49|
91781402|NCT02605122|183442139|OTHER||Achievement of Clinical Improvement|68.7|||||TWO_SIDED|95.0|58.0|78.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||78|58|
91781403|NCT02605122|183442140|OTHER||Achievement of Clinical Cure|62.0|||||TWO_SIDED|95.0|50.0|73.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson was used to determine confidence intervals.|Clopper-Pearson|||||73|50|
91781404|NCT00990704|183442141|SUPERIORITY_OR_OTHER||Difference between arms in percentage|13.6||||0.518|TWO_SIDED|95.0|-22.36|49.63|||Fisher Exact|||||49.63|-22.36|0.518
91781405|NCT01399372|183442155|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.015|TWO_SIDED|95.0|0.27|0.95||One-sided significance level = 0.15|Log Rank||Reference arm = Chemotherapy|Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.||0.95|0.27|0.015
91781406|NCT01399372|183442156|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.48|TWO_SIDED|95.0|0.38|1.58||Two-sided significance level = 0.05|Log Rank||Reference arm = Chemotherapy|||1.58|0.38|0.48
91781407|NCT01399372|183442158|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,||||0.005
91781408|NCT01399372|183442159|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.18|TWO_SIDED|95.0|0.21|1.31|||Gray's test||Reference arm = Chemotherapy arm|||1.31|0.21|0.18
91781409|NCT03284307|183442188|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.043||0.012|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Dexmedetomidine, Unconsciousness vs Disconnected Consciousness||||0.012
91781410|NCT03284307|183442188|SUPERIORITY||Slope|-0.238|STANDARD_ERROR_OF_MEAN|0.199||0.236|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Ketamine, Unconsciousness vs Disconnected Consciousness||||0.236
91781411|NCT03284307|183442188|SUPERIORITY||Slope|0.166|STANDARD_ERROR_OF_MEAN|0.12||0.174|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Propofol, Unconsciousness vs Disconnected Consciousness||||0.174
91781412|NCT03284307|183442188|SUPERIORITY||Slope|0.052|STANDARD_ERROR_OF_MEAN|0.111||0.64|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Sleep, Unconsciousness vs Disconnected Consciousness||||0.640
91781413|NCT03284307|183442190|SUPERIORITY|||||||0.134||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Card Sorting Score||||0.134
91781414|NCT03284307|183442190|SUPERIORITY|||||||0.012||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Card Sorting Score||||0.012
91709047|NCT03035916|183311323|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91587913|NCT00323297|183065006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|11.722||0.5802|TWO_SIDED|90.0|-21.843|17.087||A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.|ANCOVA|The mean difference in method of estimation is the difference between Sildenafil - placebo.||"The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one-sided significance level of 0.05, assuming a standard deviation of 60 meters.~This primary statistical analysis was carried for Week 12 data."||17.087|-21.843|0.5802
91587914|NCT01498289|183065026|SUPERIORITY||Cox Proportional Hazard|0.91||||0.83|TWO_SIDED|95.0|0.41|2.05|||Regression, Cox|||||2.05|0.41|0.83
91587915|NCT01498289|183065027|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.02|TWO_SIDED|95.0|0.5|0.93|||Regression, Cox|||||0.93|0.50|0.02
91587916|NCT01498289|183065028|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2|TWO_SIDED|95.0|0.61|1.11|||Regression, Cox|||||1.11|0.61|0.20
91587917|NCT01498289|183065029|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
91587918|NCT01498289|183065030|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.41|TWO_SIDED|95.0|0.44|1.4|||Regression, Cox|||Statistical analysis for Q1 ERCC1||1.40|0.44|0.41
91587919|NCT01498289|183065030|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.06|TWO_SIDED|95.0|0.32|1.02|||Regression, Cox|||Statistical analysis for Q2 ERCC1||1.02|0.32|0.06
91587920|NCT01498289|183065030|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.66|TWO_SIDED|95.0|0.49|1.58|||Regression, Cox|||Statistical analysis for Q3 ERCC1||1.58|0.49|0.66
91587921|NCT01498289|183065030|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.31|||Regression, Cox|||Statistical analysis for Q4 ERCC1||1.31|0.42|0.30
91587922|NCT04526197|183065056|OTHER|Confidence Interval|Ratio of geometric LS means|0.881|||||TWO_SIDED|90.0|0.776|1.001||||||||1.001|0.776|
91587923|NCT04526197|183065057|OTHER|Confidence Interval|Ratio of geometric LS means|1.016|||||TWO_SIDED|90.0|0.959|1.077||||||||1.077|0.959|
91709048|NCT03035916|183311324|OTHER|||||||0.412|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.412
91781415|NCT03284307|183442190|SUPERIORITY|||||||0.487||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|1 degree of freedom||NIH Toolbox Card Sorting Score||||0.487
91781416|NCT03284307|183442190|SUPERIORITY|||||||0.046||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Flanker Score||||0.046
91521256|NCT02954354|182917047|SUPERIORITY||Difference|-23.1||||0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.0001
91587924|NCT04526197|183065058|OTHER|Confidence Interval|Ratio of geometric LS means|1.01|||||TWO_SIDED|90.0|0.954|1.07||||||||1.070|0.954|
91587925|NCT00381303|183065066|NON_INFERIORITY_OR_EQUIVALENCE|Test for non-inferiority (Delta=15%)|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|0.052||0.3|TWO_SIDED|95.0|-19.85|0.68||P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)|Regression, Logistic|Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.||"Confidence interval of the difference in proportion of response between two sexes estimated by:~* Application of delta method to be obtained Standard Error (SE)~* Calculation of lower and upper bound using normal approximation to the difference in response rates"||0.68|-19.85|0.30
91587926|NCT03933774|183065140|SUPERIORITY|||||||0.002||||||P value \< 0.05 was considered significant.|t-test, 2 sided|||Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.||||0.002
91781417|NCT03284307|183442190|SUPERIORITY|||||||0.01||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Flanker Score||||0.010
91587927|NCT03933774|183065141|SUPERIORITY|||||||0.479||||||P value \< 0.05 was considered significant.|McNemar|||Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.||||0.479
91587928|NCT01777269|183065142|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.0|||<|0.001|TWO_SIDED|95.0|-10.22|-5.79|||mixed-model repeated-measures|||||-5.79|-10.22|<0.001
91587929|NCT01777269|183065143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.11|||<|0.001|TWO_SIDED|95.0|-6.01|-2.21|||mixed-model repeated-measures||Month 1|||-2.21|-6.01|<0.001
91587930|NCT01777269|183065143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.43|||<|0.001|TWO_SIDED|95.0|-8.45|-4.41|||Adjusted mean difference||Month 3|||-4.41|-8.45|<0.001
91587931|NCT01777269|183065143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.04|||<|0.001|TWO_SIDED|95.0|-11.31|-6.77|||mixed-model repeated-measures||Month 6|||-6.77|-11.31|<0.001
91587932|NCT01777269|183065143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.82|||<|0.001|TWO_SIDED|95.0|-10.96|-6.67|||mixed-model repeated-measures||Month 9|||-6.67|-10.96|<0.001
91587933|NCT01777269|183065145|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2||||0.37|TWO_SIDED|95.0|-0.62|0.23|||mixed-model repeated-measures||Month 1|||0.23|-0.62|0.37
91587934|NCT01777269|183065145|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24||||0.33|TWO_SIDED|95.0|-0.71|0.24|||mixed-model repeated-measures||Month 3|||0.24|-0.71|0.33
91587935|NCT01777269|183065145|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.37||||0.16|TWO_SIDED|95.0|-0.88|0.15|||mixed-model repeated-measures||Month 6|||0.15|-0.88|0.16
91587936|NCT01777269|183065145|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68||||0.009|TWO_SIDED|95.0|-1.19|-0.17|||mixed-model repeated-measures||Month 9|||-0.17|-1.19|0.009
91587937|NCT01777269|183065145|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46||||0.091|TWO_SIDED|95.0|-0.99|0.07|||mixed-model repeated-measures||Month 12|||0.07|-0.99|0.091
91587938|NCT01777269|183065146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.89|||<|0.001|TWO_SIDED|95.0|-4.07|-1.7|||mixed-model repeated-measures||Month 1|||-1.70|-4.07|<0.001
91781418|NCT03284307|183442190|SUPERIORITY|||||||0.356||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|||NIH Toolbox Flanker Score||||0.356
91781419|NCT03284307|183442191|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
91781420|NCT03284307|183442191|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|14 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
91587939|NCT01777269|183065146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|||<|0.001|TWO_SIDED|95.0|-6.59|-3.9|||mixed-model repeated-measures||Month 3|||-3.90|-6.59|<0.001
91587940|NCT01777269|183065146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.82|||<|0.001|TWO_SIDED|95.0|-8.3|-5.34|||mixed-model repeated-measures||Month 6|||-5.34|-8.30|<0.001
91587941|NCT01777269|183065146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.05|||<|0.001|TWO_SIDED|95.0|-8.51|-5.59|||mixed-model repeated-measures||Month 9|||-5.59|-8.51|<0.001
91587942|NCT01777269|183065146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.92|||<|0.001|TWO_SIDED|95.0|-8.47|-5.38|||mixed-model repeated-measures||Month 12|||-5.38|-8.47|<0.001
91587943|NCT01777269|183065147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.94||||0.012|TWO_SIDED|95.0|-1.67|-0.21|||mixed-model repeated-measures||Month 1|||-0.21|-1.67|0.012
91587944|NCT01777269|183065147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.93||||0.017|TWO_SIDED|95.0|-1.69|-0.17|||mixed-model repeated-measures||Month 3|||-0.17|-1.69|0.017
91587945|NCT01777269|183065147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.57|-0.88|||mixed-model repeated-measures||Month 6|||-0.88|-2.57|<0.001
91587946|NCT01777269|183065147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.009|TWO_SIDED|95.0|-2.01|-0.3|||mixed-model repeated-measures||Month 9|||-0.30|-2.01|0.009
91587947|NCT01777269|183065147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.047|TWO_SIDED|95.0|-1.65|-0.01|||mixed-model repeated-measures||Month 12|||-0.01|-1.65|0.047
91587948|NCT01777269|183065148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.45|-0.85|||mixed-model repeated-measures||Week 2|||-0.85|-2.45|<0.001
91587949|NCT01777269|183065148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55||||0.24|TWO_SIDED|95.0|-1.47|0.37|||mixed-model repeated-measures||Month 1|||0.37|-1.47|0.24
91781421|NCT03284307|183442191|SUPERIORITY|||||||0.067||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Predictive Coding Task Accuracy||||0.067
91781422|NCT03284307|183442192|SUPERIORITY|||||||0.5||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.5
91587950|NCT01777269|183065148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.006|TWO_SIDED|95.0|-2.19|-0.36|||mixed-model repeated-measures||Month 3|||-0.36|-2.19|0.006
91587951|NCT01777269|183065148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.74|-0.72|||mixed-model repeated-measures||Month 6|||-0.72|-2.74|<0.001
91587952|NCT01777269|183065148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.34||||0.013|TWO_SIDED|95.0|-2.4|-0.28|||mixed-model repeated-measures||Month 9|||-0.28|-2.40|0.013
91647844|NCT00123487|183187893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was claimed if the lower bound of the 95% CI for difference (QD - BD) was ≥ -12%.|Percent Difference|0.2|||||TWO_SIDED|95.0|-7.8|8.1||||||Primary endpoint was to be assessed at 6-Months: Assuming a 45% MaHR rate in the 70 mg BID participants, the primary efficacy analysis required a total of 540 participants, approximately 270 in each dosing schedule, giving at least 80% power to deduce non-inferiority of the QD schedule relative to the BID schedule if the lower bound of the 95% CI for the difference in MaHR rates (MaHRRQD - MaHRRBID) is greater than -12%.||8.1|-7.8|
91647845|NCT05788237|183187945|OTHER||GMR|0.84|||||TWO_SIDED|95.0|0.662|1.062||||||GMR for RSV A: RSVpreF + qIRV combination to RSVpreF alone.||1.062|0.662|
91781423|NCT03284307|183442192|SUPERIORITY|||||||0.37||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|11 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.37
91781424|NCT03284307|183442192|SUPERIORITY|||||||0.12||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.12
91587953|NCT01777269|183065148|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.12|-0.83|||mixed-model repeated-measures||Month 12|||-0.83|-3.12|<0.001
91587954|NCT01777269|183065149|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4||||0.036|TWO_SIDED|95.0|-0.78|-0.03|||mixed-model repeated-measures||Week 2|||-0.03|-0.78|0.036
91587955|NCT01777269|183065149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0||||1|TWO_SIDED|95.0|-0.37|0.37|||mixed-model repeated-measures||Month 1|||0.37|-0.37|1.00
91587956|NCT01777269|183065149|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26||||0.21|TWO_SIDED|95.0|-0.67|0.15|||mixed-model repeated-measures||Month 3|||0.15|-0.67|0.21
91587957|NCT01777269|183065149|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62||||0.009|TWO_SIDED|95.0|-1.09|-0.15|||mixed-model repeated-measures||Month 6|||-0.15|-1.09|0.009
91587958|NCT01777269|183065149|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.45||||0.056|TWO_SIDED|95.0|-0.91|0.01|||mixed-model repeated-measures||Month 9|||0.01|-0.91|0.056
91587959|NCT01777269|183065149|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.58||||0.023|TWO_SIDED|95.0|-1.08|-0.08|||mixed-model repeated-measures||Month 12|||-0.08|-1.08|0.023
91587960|NCT01777269|183065150|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|||<|0.001|TWO_SIDED|95.0|-3.89|-2.1|||mixed-model repeated-measures||Week 2|||-2.10|-3.89|<0.001
91587961|NCT01777269|183065150|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.15|-1.06|||mixed-model repeated-measures||Month 1|||-1.06|-3.15|<0.001
91587962|NCT01777269|183065150|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.25|-0.98|||mixed-model repeated-measures||Month 3|||-0.98|-3.25|<0.001
91587963|NCT01777269|183065150|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.76|-1.3|||mixed-model repeated-measures||Month 6|||-1.30|-3.76|<0.001
91587964|NCT01777269|183065150|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3||||0.042|TWO_SIDED|95.0|-2.56|-0.05|||mixed-model repeated-measures||Month 9|||-0.05|-2.56|0.042
91587965|NCT01777269|183065150|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.51|||<|0.001|TWO_SIDED|95.0|-4.87|-2.14|||mixed-model repeated-measures||Month 12|||-2.14|-4.87|<0.001
91587966|NCT01777269|183065151|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.78|||<|0.001|TWO_SIDED|95.0|-10.07|-5.49|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=2 points improvement at any time post-baseline visit|||-5.49|-10.07|<0.001
91587967|NCT01777269|183065151|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.39|||<|0.001|TWO_SIDED|95.0|-9.79|-4.99|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=3 points improvement at any time post-baseline visit|||-4.99|-9.79|<0.001
91587968|NCT01777269|183065152|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.79|||<|0.001|TWO_SIDED|95.0|-10.22|-5.35|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=25 points improvement at any time post-baseline visit|||-5.35|-10.22|<0.001
91587969|NCT00504881|183065154|SUPERIORITY_OR_OTHER||Percent Reduction over Placebo|7.3|||=|0.125|TWO_SIDED|95.0|-2.2|15.9|||ANCOVA|||ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.||15.9|-2.2|=0.125
91587970|NCT01783041|183065177|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
91587971|NCT01783041|183065178|OTHER||||||<|0.05||||||These are calculated p values.|Wilcoxon (Mann-Whitney)|This analysis applies to all sub-scales that were compared between the 2 study groups.||||||<0.05
91587972|NCT01783041|183065179|OTHER||||||<|0.05||||||Reported p values have been calculated.|t-test, 2 sided|Differences between the groups were analyzed using a two sided t-test.||||||<0.05
91587973|NCT01783041|183065180|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
91587974|NCT00803270|183065224|SUPERIORITY_OR_OTHER||Difference of proportions|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.99|TWO_SIDED|95.0|-0.28|0.44|||Fisher Exact|||||0.44|-0.28|0.99
91587975|NCT00803270|183065225|SUPERIORITY_OR_OTHER||difference of proportions|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.08|TWO_SIDED|95.0|0.03|0.87||Fisher's Exact Test of equality of percent meeting optimal outcome.|Fisher Exact|||||0.87|0.03|0.08
91647846|NCT05788237|183187945|OTHER||GMR|0.79|||||TWO_SIDED|95.0|0.614|1.013||||||GMR for RSV B: RSVpreF + qIRV combination to RSVpreF alone.||1.013|0.614|
91647847|NCT05788237|183187946|OTHER||GMR|0.81|||||TWO_SIDED|95.0|0.632|1.044||||||GMR for HAI: H1N1 A/Wisconsin: RSVpreF + qIRV combination to RSVpreF alone.||1.044|0.632|
91781425|NCT03249116|183442200|SUPERIORITY||F statistic|0.33||||0.723|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time||||||.723
91587976|NCT01966471|183065226|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.827||95.0|0.71|1.32|||Log Rank|||||1.32|0.71|0.8270
91587977|NCT01966471|183065227|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9291||95.0|0.77|1.34|||Log Rank|||||1.34|0.77|0.9291
91647848|NCT05788237|183187946|OTHER||Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.567|0.957||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV combination to RSVpreF alone.||0.957|0.567|
91587978|NCT01966471|183065228|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8756||95.0|0.74|1.3|||Log Rank|||||1.30|0.74|0.8756
91587979|NCT01966471|183065229|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9341||95.0|0.75|1.31|||Log Rank|||||1.31|0.75|0.9341
91647849|NCT05788237|183187946|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.741|1.181||||||GMR for HAI: B/Austria: RSVpreF + qIRV combination to RSVpreF alone.||1.181|0.741|
91587980|NCT01966471|183065230|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4577||95.0|0.61|1.25|||Log Rank|||||1.25|0.61|0.4577
91587981|NCT01966471|183065231|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2864||95.0|0.83|1.84|||Log Rank|||||1.84|0.83|0.2864
91587982|NCT02092220|183065246|SUPERIORITY||Mean Difference (Final Values)|-20.28|STANDARD_DEVIATION|24.59|<|0.0001|TWO_SIDED|95.0|-28.0|-12.56||Repeated measures model.|t-test, 2 sided||Bionic Pancreas Arm - Usual Care Arm|||-12.56|-28.00|<0.0001
91587983|NCT02092220|183065247|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.0001|TWO_SIDED|95.0|0.8|1.8||Repeated measures model.|t-test, 2 sided|||||1.8|0.8|<0.0001
91587984|NCT00593957|183065279|SUPERIORITY_OR_OTHER||||||<|0.4|||||||t-test, 2 sided|||||||<0.40
91647850|NCT05788237|183187946|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.707|1.174||||||GMR for HAI: B/Phuket: RSVpreF + qIRV combination to RSVpreF alone.||1.174|0.707|
91647851|NCT05788237|183187947|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.339||||||GMR for RSV A: RSVpreF + qIRV 1.0 mL (Group 1) combination to RSVpreF + qIRV 0.5 mL (Group 2)||1.339|0.820|
91647852|NCT05788237|183187947|OTHER||Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.833|1.352||||||GMR for RSV B: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.352|0.833|
91647853|NCT05788237|183187948|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.875|1.614||||||GMR for HAI: H1N1 A/Sydney: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.614|0.875|
91587985|NCT00593957|183065279|SUPERIORITY_OR_OTHER||||||<|0.62||95.0|||||t-test, 2 sided|||||||<0.62
91587986|NCT00593957|183065279|SUPERIORITY_OR_OTHER||||||<|0.38||95.0|||||t-test, 2 sided|||||||<0.38
91587987|NCT00593957|183065281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.1|||||||ANOVA|||Null hypothesis is that there would be no significant difference in social abilities as measured by the SSI score in this treatment group baseline to 6 months post-treatment.||||<0.10
91587988|NCT00593957|183065281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|||<|0.5|||||||ANOVA|||||||<0.50
91587989|NCT00593957|183065281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.48|||||||ANOVA|||||||<0.48
91587990|NCT00593957|183065282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.947|||<|0.05|||||||ANOVA|||||||<0.05
91587991|NCT02411578|183065286|SUPERIORITY|||||||0.99||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.||||0.99
91587992|NCT02411578|183065287|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.34
91587993|NCT02411578|183065288|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.01
91781426|NCT03249116|183442201|SUPERIORITY||F statistic|1.34||||0.271|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time||||||.271
91781427|NCT03249116|183442202|SUPERIORITY||F statistic|0.45||||0.638|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time||||||.638
91781428|NCT03249116|183442203|SUPERIORITY||F statistic|0.14||||0.868|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: number of errors between-subjects factors: condition, social anxiety||||||.868
91781429|NCT03249116|183442204|SUPERIORITY||F statistic|0.21||||0.809|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety||||||.809
91781430|NCT00221117|183442211|OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
91587994|NCT02411578|183065289|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.02
91587995|NCT02411578|183065290|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.86
91647854|NCT05788237|183187948|OTHER||Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.867|1.473||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.473|0.867|
91647855|NCT05788237|183187948|OTHER||Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.849|1.383||||||GMR for HAI: B/Austria: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.383|0.849|
91647856|NCT05788237|183187948|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.866|1.392||||||GMR for HAI: B/Phuket: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.392|0.866|
91647857|NCT00581386|183187999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125||||0.013||95.0|1.27|7.67|||Regression, Logistic|Logistic regression Number of obs = 217, LR chi2(2)=10.89, Prob\>chi2=0.0043,Log likelihood = -112.87788, Pseudo R2=0.0460|this is a simple odds ratio|||7.67|1.27|0.013
91709049|NCT03035916|183311324|OTHER|||||||0.592|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.592
91709050|NCT03035916|183311324|OTHER|||||||0.796|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.796
91709051|NCT03035916|183311324|OTHER|||||||0.576|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.576
91709052|NCT03035916|183311324|OTHER|||||||0.427|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.427
91709053|NCT03035916|183311324|OTHER|||||||0.201|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.201
91709054|NCT03035916|183311324|OTHER|||||||0.872|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.872
91709055|NCT03035916|183311324|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91709056|NCT03035916|183311324|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91781431|NCT00221117|183442212|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann-Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).||||0.05
91781432|NCT00499616|183442216|OTHER||Log Rank Test Statistic|0.9841||||0.3212|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.||||.3212
91781433|NCT00499616|183442220|OTHER||Log-Rank Test Statistic|5.0049||||0.0253|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.||||.0253
91781434|NCT00499616|183442221|OTHER|The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|Log Rank Test Statistic|2.6709||||0.1022|TWO_SIDED|95.0|||||Log Rank|||||||.1022
91781435|NCT00499616|183442222|OTHER||Chi-Square Test Statistic|9.9111||||0.0016|TWO_SIDED|95.0|||||Chi-squared|||The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.||||.0016
91709057|NCT03035916|183311324|OTHER|||||||0.165|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.165
91781436|NCT02223858|183442279|SUPERIORITY|A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.791|||||||Mixed Models Analysis|All models adjusted for site.||||||0.791
91781437|NCT02223858|183442280|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.88|||||||Mixed Models Analysis|All models adjusted for site.||||||0.880
91781438|NCT02223858|183442281|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.||||||0.901|||||||Mixed Models Analysis|All models adjusted for site.||||||0.901
91781439|NCT00241839|183442288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|2.24||0.059|TWO_SIDED|95.0|-0.17|8.7|||t-test, 2 sided|Satterthwaite correction for possibly unequal variance was made|A positive value of the estimated value would favor the allopurinol arm. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We compared the drop in baseline of diastolic BP for the two treatment groups Allopurinol vs. Placebo by a Satterthwaite corrected t-test.||8.7|-0.17|0.059
91781440|NCT00241839|183442289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|1.59||0.47|TWO_SIDED|95.0|-2.0|4.3||Positive numbers indicate a drop. We compared baseline minus value at treatment end for the two treatments.|t-test, 2 sided|Satterthwaite correction was used for potentially unequal variances.|The analysis is limited to those with both baseline and 8-10 week data on this variable.|||4.3|-2.0|0.47
91781441|NCT00241839|183442290|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|2.11||0.002|TWO_SIDED|95.0|-11.0|-2.6|||t-test, 2 sided|Sattherthwaite correction was used|The analysis is limited to those with both baseline and 8-10 week data on this variable. The 24 hour was in the opposite direction of the cuff.|||-2.6|-11.0|0.0020
91781442|NCT00241839|183442291|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|1.72|2.59|||t-test, 2 sided|Satterthwaite correction was used.|Allopurinol was associated with a significant decrease in uric acid over the treatment period as compared to placebo. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We expected allopurinol to be associated with a decrease in uric acid.||2.59|1.72|<0.001
91781443|NCT04954833|183442292|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR. A value of 0.05 logMAR is approximately 2.5 letters on the ETDRS chart.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|-0.01|0.02|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||0.02|-0.01|
91781444|NCT04954833|183442293|NON_INFERIORITY|A non-inferiority margin of 10% was used. A 10% of difference in the rate of lens fit acceptance is considered clinically significant.|Posterior mean difference of proportions|0.0|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|-0.009|0.01|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference between the Test and Control (Test - Control) was used to evaluate non-inferiority.|Interval presented is a 95% Credible interval|||0.010|-0.009|
91781445|NCT05021978|183442326|OTHER|||||||0.1048||||||Change from baseline to Day 7 in TETRAS Upper Limb Score|Mixed Models Analysis|Includes timepoint as fixed effect and baseline TETRAS score as a covariate. Within subject variability modeled using unstructured covariance pattern.||Sample size is a convenience sample determined according to feasibility to provide sufficient and safety data to inform the development of future controlled studies with PRAX-944. In the open-label phase of the trial (Part A ), at least 10 participants would provide an 80% probability of observing at least 1 AE with an underlying incidence of 15% or greater and provide approximately 80% power to detect an effect size of 1.0 on the primary endpoint change from baseline in TETRAS Upper Limb score.||||0.1048
91647858|NCT00581386|183187999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.003||95.0|1.57|9.29|||Odds ratio|||||9.29|1.57|0.003
91647859|NCT00581386|183188000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.006||||0.006||95.0|||||t-test, 2 sided|||||||0.006
91647860|NCT00581386|183188001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.088||||0.003||95.0|1.728|14.99|||Regression, Logistic|||||14.99|1.728|0.003
91781446|NCT05021978|183442326|OTHER|||||||0.0028||||||Change from baseline to Day 14 in TETRAS UL score|Mixed Models Analysis|||||||0.0028
91781447|NCT05021978|183442330|OTHER|||||||0.4025|||||||Mixed Models Analysis|Change from baseline to Day 7||||||0.4025
91781448|NCT05021978|183442330|OTHER|||||||0.0766||||||Change from baseline to Day 14|Mixed Models Analysis|||||||0.0766
91647861|NCT00581386|183188001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.22||||0.0004||95.0|2.419|21.527|||Regression, Logistic|||||21.527|2.419|0.0004
91647862|NCT00681824|183188003|SUPERIORITY_OR_OTHER|||||||0.7159||95.0|||||likelihood ratio of chi squared test|||||||0.7159
91709058|NCT03035916|183311324|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91647863|NCT03101293|183188052|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).|LS Mean Ratio|1.343||||0.0058|TWO_SIDED|90.0|1.146|1.574|||ANOVA|||||1.574|1.146|0.0058
91647864|NCT03101293|183188053|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.121||||0.1763|TWO_SIDED|90.0|0.969|1.298|||ANOVA|||||1.298|0.969|0.1763
91647865|NCT03101293|183188054|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.154||||0.2745|TWO_SIDED|90.0|0.929|1.433|||ANOVA|||||1.433|0.929|0.2745
91587996|NCT02411578|183065291|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.95
91587997|NCT02411578|183065292|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.78
91587998|NCT02411578|183065293|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.21
91587999|NCT02411578|183065294|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.09
91588000|NCT02411578|183065295|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.49
91588001|NCT02411578|183065296|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.63
91647866|NCT03182920|183188078|SUPERIORITY||Ratio of geometric least squares means|1.21|||||TWO_SIDED|90.0|0.962|1.52||||||||1.52|0.962|
91588002|NCT02411578|183065297|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.41
91647867|NCT03182920|183188079|SUPERIORITY||Ratio of geometric least squares means|1.26|||||TWO_SIDED|90.0|1.03|1.55||||||||1.55|1.03|
91647868|NCT00361257|183188081|SUPERIORITY_OR_OTHER||Slope|0.064|STANDARD_ERROR_OF_MEAN|0.164||0.651|TWO_SIDED|95.0|-0.258|0.386||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.|The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).|The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.||0.386|-0.258|0.651
91709059|NCT03035916|183311324|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91781449|NCT05021978|183442331|OTHER|||||||0.2501||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2501
91588003|NCT02411578|183065298|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.80
91588004|NCT02411578|183065299|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.13
91588005|NCT02411578|183065300|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.70
91588006|NCT02411578|183065301|SUPERIORITY|||||||0.93||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.93
91588007|NCT02411578|183065302|SUPERIORITY|||||||0.66||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.66
91588008|NCT02411578|183065303|SUPERIORITY|||||||0.08||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.08
91588009|NCT01231516|183065328|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.4||||0.03|TWO_SIDED|95.0|0.7|14.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Adjusted difference in proportion which is based on the difference in percentage, adjusted for Baseline (BL) stratification factors.|Analysis was adjusted for BL stratification factors: HIV-1 RNA (\<=50000 versus \[vs\]\>50000 c/mL), darunavir-ritonavir use without primary protease inhibitor mutations (yes vs no), and phenotypic susceptibility score (2 vs \<2) to background regimen.|||14.2|0.7|0.030
91588010|NCT02460666|183065344|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.3
91588011|NCT02460666|183065345|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
91588012|NCT02460666|183065346|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
91781450|NCT05021978|183442331|OTHER|||||||0.1874||||||Chnage from baseline to Day 14|Mixed Models Analysis|||||||0.1874
91588013|NCT02460666|183065347|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91588014|NCT05266586|183065349|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
91588015|NCT05266586|183065350|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
91588016|NCT05266586|183065351|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
91588017|NCT05266586|183065352|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
91588018|NCT05266586|183065353|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
91588019|NCT05266586|183065354|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
91588020|NCT05266586|183065355|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
91647869|NCT00361257|183188082|SUPERIORITY_OR_OTHER||Slope|0.091|STANDARD_ERROR_OF_MEAN|0.116||0.434|TWO_SIDED|95.0|-0.14|0.323||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.||The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.||0.323|-0.140|0.434
91647870|NCT00361257|183188083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.569|STANDARD_DEVIATION|0.469||0.337|TWO_SIDED|95.0|0.625|3.936||The p-value was not adjusted for multiple comparisons.|Regression, Cumulative Logistic|The model was adjusted for the stratification variables and the CNS penetration score.||The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.||3.936|0.625|0.337
91647871|NCT00361257|183188084|SUPERIORITY_OR_OTHER||Slope|0.502|STANDARD_ERROR_OF_MEAN|0.428||0.243|TWO_SIDED|95.0|-0.349|1.354||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.||The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.||1.354|-0.349|0.243
91781451|NCT05021978|183442332|OTHER|||||||0.4722||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.4722
91781452|NCT05021978|183442332|OTHER|||||||0.6215||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.6215
91588021|NCT05266586|183065356|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
91588022|NCT05266586|183065357|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
91588023|NCT05266586|183065358|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
91588024|NCT05266586|183065359|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
91588025|NCT05266586|183065360|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
91588026|NCT05266586|183065361|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
91588027|NCT05266586|183065362|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
91588028|NCT05266586|183065363|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
91588029|NCT05266586|183065364|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
91588030|NCT05266586|183065365|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
91588031|NCT05266586|183065366|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
91781453|NCT05021978|183442332|OTHER|||||||0.9648||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9648
91781454|NCT05021978|183442332|OTHER|||||||0.2855||||||Item 7 Handwriting change from baseline to Day 14|Mixed Models Analysis|||||||0.2855
91781455|NCT05021978|183442332|OTHER|||||||0.205||||||Item 6 Archimedes Spiral (right) change from baseline to Day 14|Mixed Models Analysis|||||||0.2050
91781456|NCT05021978|183442332|OTHER|||||||0.2364||||||Item 6 Archimedes Spiral (left) change from baseline to Day 14|Mixed Models Analysis|||||||0.2364
91781457|NCT05021978|183442336|OTHER|||||||0.0216|||||||Mixed Models Analysis|||||||0.0216
91781458|NCT05021978|183442337|OTHER|||||||0.1042||||||Change from baseline Day 7|Mixed Models Analysis|||||||0.1042
91781459|NCT05021978|183442337|OTHER|||||||0.0257||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.0257
91781460|NCT05021978|183442338|OTHER|||||||0.2971||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2971
91781461|NCT05021978|183442338|OTHER|||||||0.2034||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.2034
91781462|NCT05021978|183442338|OTHER|||||||0.1105||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.1105
91781463|NCT05021978|183442339|OTHER|||||||0.005||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.0050
91709060|NCT03035916|183311324|OTHER|||||||0.305|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.305
91781464|NCT05021978|183442339|OTHER|||||||0.0018||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0018
91781465|NCT05021978|183442339|OTHER|||||||0.0061||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0061
91781466|NCT05021978|183442340|OTHER|||||||0.9776||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.9776
91781467|NCT05021978|183442340|OTHER|||||||0.1962||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.1962
91588032|NCT01323621|183065386|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.267||95.0|-0.022|0.08|||ANCOVA||ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|||0.080|-0.022|0.267
91781468|NCT05021978|183442340|OTHER|||||||0.9419||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9419
91781469|NCT05021978|183442340|OTHER|||||||0.0668||||||Item 6 Archimedes Spiral (right) change from baseline to Day 21|Mixed Models Analysis|||||||0.0668
91781470|NCT05021978|183442340|OTHER|||||||0.9191||||||Item 6 Archimedes Spiral (left) change from baseline to Day 21|Mixed Models Analysis|||||||0.9191
91781471|NCT05021978|183442340|OTHER|||||||0.6075||||||Item 7 Handwriting change from baseline to Day 21|Mixed Models Analysis|||||||0.6075
91781472|NCT05021978|183442340|OTHER|||||||0.246||||||Item 6 Archimedes Spiral (right) change from baseline to Day 42|Mixed Models Analysis|||||||0.2460
91781473|NCT05021978|183442340|OTHER|||||||0.6736||||||Item 6 Archimedes Spiral (left) change from baseline to Day 42|Mixed Models Analysis|||||||0.6736
91588033|NCT00954421|183065388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.6|STANDARD_DEVIATION|19.4||0.026|TWO_SIDED|95.0|-30.61|-4.65|||two-sided sign-rank test||p-value assessed via sign-rank test (pre-planned method)|The null hypothesis is that the mean change in Tremor Rating Scale score from baseline to six months post-implant (with VIM and VO stimulators turned ON) will be zero||-4.65|-30.61|.026
91781474|NCT05021978|183442340|OTHER|||||||0.8511||||||Item 7 Handwriting change from baseline to Day 42|Mixed Models Analysis|||||||0.8511
91781475|NCT05021978|183442341|OTHER|||||||0.1505||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.1505
91781476|NCT05021978|183442341|OTHER|||||||0.0543||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0543
91781477|NCT05021978|183442341|OTHER|||||||0.0015||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0015
91781478|NCT05021978|183442342|OTHER|||||||0.8638||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.8638
91781479|NCT05021978|183442342|OTHER|||||||0.0605||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0605
91781480|NCT05021978|183442342|OTHER|||||||0.0871||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0871
91781481|NCT00043979|183442359|SUPERIORITY_OR_OTHER|||||||0.0003||||||7 participants who did not receive a transplant compared with 21 participants transplanted.|Kaplan-Meier|||||||.0003
91781482|NCT03096288|183442373|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.169|TWO_SIDED|95.0|-9.0|52.0|||t-test, 2 sided|||||52|-9|0.169
91781483|NCT03096288|183442373|SUPERIORITY||Median Difference (Final Values)|17.0||||0.236|TWO_SIDED|95.0|-11.0|45.0|||t-test, 2 sided|||||45|-11|0.236
91781484|NCT00414596|183442380|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|The primary pain end-point was assessed by a mixed effect model with time (visit) and as fixed effects and subject as random effect.||"Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience \>50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients."||||.0001
91781485|NCT02754440|183442456|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
91781486|NCT02754440|183442456|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
91781487|NCT02754440|183442456|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
91588034|NCT00954421|183065389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4|STANDARD_DEVIATION|9.1||0.011|TWO_SIDED|95.0|2.2|14.5||Sign rank test was pre-planned for P-value|Sign-Rank test||p-value assessed using sign rank test|The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when both stimulators are on (VIM and VO), versus when both stimulators are off, will be zero (i.e., that there will be no difference in effect between having both stimulators on versus both stimulators off)||14.5|2.2|0.011
91647872|NCT00361257|183188085|SUPERIORITY_OR_OTHER||Slope|0.293|STANDARD_ERROR_OF_MEAN|0.153||0.059|TWO_SIDED|95.0|-0.011|0.596||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.||The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.||0.596|-0.011|0.059
91781488|NCT02754440|183442457|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.957|STANDARD_ERROR_OF_MEAN|0.021|||ONE_SIDED|95.0|0.904|||||||Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.904|
91781489|NCT02754440|183442457|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
91781490|NCT02754440|183442457|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
91781491|NCT01189032|183442459|SUPERIORITY_OR_OTHER|||||||0.004||||||It's the p-value of linear trend. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.004
91781492|NCT01189032|183442459|SUPERIORITY_OR_OTHER|||||||0.006||||||It's the p-value of Saturated at 1% DE-089. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.006
91781493|NCT01995838|183442462|SUPERIORITY||LS Mean Difference|0.51||||0.0651|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|Baseline value and treatment as covariates.||||1.06|-0.03|0.0651
91781494|NCT01995838|183442462|SUPERIORITY||LS Mean Difference|0.13||||0.649|TWO_SIDED|95.0|-0.44|0.7|||ANCOVA|Baseline value and treatment as covariates.||||0.70|-0.44|0.6490
91781495|NCT01995838|183442462|SUPERIORITY||LS Mean Difference|0.43||||0.1059|TWO_SIDED|95.0|-0.09|0.94|||ANCOVA|Baseline value and treatment as covariates.||||0.94|-0.09|0.1059
91781496|NCT01995838|183442462|SUPERIORITY||LS Mean Difference|0.01||||0.9818|TWO_SIDED|95.0||0.55|||ANCOVA|Baseline value and treatment as covariates.||||0.55|-0. 54|0. 9818
91781497|NCT01995838|183442462|SUPERIORITY||LS Mean Difference|0.38||||0.1071|TWO_SIDED|95.0|-0.08|0.85|||ANCOVA|Baseline value and treatment as covariates.||||0.85|-0.08|0. 1071
91781498|NCT01995838|183442462|SUPERIORITY||LS Mean Difference|0.68||||0.0063|TWO_SIDED|95.0|0.19|1.17|||ANCOVA|Baseline value and treatment as covariates.||||1.17|0.19|0.0063
91781499|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|4.57||||0.0083|TWO_SIDED|95.0|1.19|7.94|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||7.94|1.19|0.0083
91781500|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|4.44||||0.0151|TWO_SIDED|95.0|0.86|8.01|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.01|0.86|0.0151
91781501|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|5.74||||0.0005|TWO_SIDED|95.0|2.54|8.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.93|2.54|0.0005
91781502|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|8.09|||<|0.0001|TWO_SIDED|95.0|4.73|11.45|||ANCOVA|||Days 1-2||11.45|4.73|<0.0001
91781503|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|10.06|||<|0.0001|TWO_SIDED|95.0|7.2|12.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||12.93|7.20|<0.0001
91588035|NCT00954421|183065389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73|STANDARD_DEVIATION|8.49||0.68||95.0|-4.96|6.42|||two-sided sign rank test|two sided sign rank test as pre-planned||The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when VO is on and VIM is off, versus when VIM is on and VO is off, will be zero (i.e., that there will be no difference in effect between having exclusively VIM versus VO on)||6.42|-4.96|.68
91588036|NCT00883051|183065390|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||<|0.0001|||||||Cochran-Armitage test for trend|||||||<0.0001
91588037|NCT00883051|183065391|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||=|0.0006|||||||Cochran-Armitage test for trend]|||||||=0.0006
91588038|NCT00458341|183065408|OTHER|||||||0.133||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.133
91588039|NCT00458341|183065408|OTHER|||||||0.19||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.190
91588040|NCT00458341|183065408|OTHER|||||||0.123||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.123
91588041|NCT00458341|183065408|OTHER|||||||0.592||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.592
91588042|NCT00458341|183065409|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
91588043|NCT00458341|183065409|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
91647873|NCT00361257|183188086|SUPERIORITY_OR_OTHER||Slope|-0.083|STANDARD_ERROR_OF_MEAN|0.147||0.572|TWO_SIDED|95.0|-0.375|0.209||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.||The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.||0.209|-0.375|0.572
91588044|NCT00458341|183065409|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
91647874|NCT00361257|183188087|SUPERIORITY_OR_OTHER||Slope|-0.086|STANDARD_ERROR_OF_MEAN|0.182||0.637|TWO_SIDED|95.0|-0.449|0.276||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.||The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.||0.276|-0.449|0.637
91647875|NCT00361257|183188088|SUPERIORITY_OR_OTHER||Slope|-0.074|STANDARD_ERROR_OF_MEAN|0.236||0.754|TWO_SIDED|95.0|-0.544|0.396||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.||The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.||0.396|-0.544|0.754
91588045|NCT00458341|183065409|OTHER|||||||0.518|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.518
91588046|NCT06515483|183065425|OTHER||Mean Difference (Final Values)|0.079||||0.323|TWO_SIDED|95.0|-0.095|0.254||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.254|-0.095|0.323
91588047|NCT06515483|183065425|OTHER||Mean Difference (Final Values)|-0.036||||0.371|TWO_SIDED|95.0|-0.156|0.084||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.084|-0.156|0.371
91781504|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|10.13|||<|0.0001|TWO_SIDED|95.0|7.18|13.08|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||13.08|7.18|<0.0001
91781505|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|0.34||||0.8505|TWO_SIDED|95.0|-3.22|3.9|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.90|-3.22|0.8505
91781506|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|3.94||||0.038|TWO_SIDED|95.0|0.22|7.66|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||7.66|0.22|0.0380
91781507|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|5.76||||0.0008|TWO_SIDED|95.0|2.4|9.12|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||9.12|2.40|0.0008
91588048|NCT06515483|183065425|OTHER||Mean Difference (Net)|-0.115||||0.12|TWO_SIDED|95.0|-0.262|0.031||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in PLI from baseline to 30 days between groups|||0.031|-0.262|0.120
91588049|NCT06515483|183065426|OTHER||Mean Difference (Final Values)|0.078||||0.27|TWO_SIDED|95.0|-0.048|0.204||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.204|-0.048|0.270
91588050|NCT06515483|183065426|OTHER||Mean Difference (Final Values)|-0.085||||0.071|TWO_SIDED|95.0|-0.203|0.033||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.033|-0.203|0.071
91588051|NCT06515483|183065426|OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.249|-0.077|||t-test, 2 sided||Comparing the mean difference in MGI from baseline to 30 days between groups|||-0.077|-0.249|<0.001
91588052|NCT06515483|183065427|OTHER||Mean Difference (Final Values)|0.31||||0.902|TWO_SIDED|95.0|-6.23|6.85||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||6.85|-6.23|0.902
91781508|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|7.78|||<|0.0001|TWO_SIDED|95.0|4.24|11.32|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||11.32|4.24|<0.0001
91588053|NCT06515483|183065427|OTHER||Mean Difference (Final Values)|-8.22||||0.006|TWO_SIDED|95.0|-16.46|0.02||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.02|-16.46|0.006
91588054|NCT06515483|183065427|OTHER||Mean Difference (Net)|-8.53||||0.032|TWO_SIDED|95.0|-16.31|-0.75||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in BOMP from baseline to 30 days between groups|||-0.75|-16.31|0.032
91588055|NCT03454828|183065430|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
91588056|NCT05104476|183065438|SUPERIORITY||Bayesian Progression Model|0.81|||||TWO_SIDED|95.0|0.56|1.13|||||Reported here is the estimated effect parameter from the Bayesian Progression Model and the associated Credibility Interval for the active arm.|||1.13|0.56|
91588057|NCT03865940|183065457|SUPERIORITY|||||||0.374|TWO_SIDED|95.0||||P-values less than 0.05 considered significant.|Regression, Cox|Testing null hypothesis that guanfacine has no effect on time from injection to return to baseline.||||||0.374
91588058|NCT03865940|183065458|SUPERIORITY||||||<|0.001||||||P-values less than 0.05 considered significant.|Regression, Logistic|Analysis adjusted for pre-injection score and accounted for repeated measures. Effect of study drug was tested using a four degree-of-freedom test.||||||<0.001
91588059|NCT03865940|183065459|SUPERIORITY|||||||0.775|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.775
91588060|NCT03865940|183065460|SUPERIORITY|||||||0.099|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.099
91588061|NCT03865940|183065461|SUPERIORITY|||||||0.907|||||||Proportional Odds Regression|The analysis was not adjusted for baseline factors.||||||0.907
91588062|NCT03865940|183065462|SUPERIORITY|||||||0.373|||||||Regression, Logistic|Adjusted for use of pain medication at baseline||||||0.373
91588063|NCT00992511|183065465|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.77|1.46||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.46|0.77|
91588064|NCT00992511|183065465|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.86|1.61||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.61|0.86|
91588065|NCT01176968|183065486|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.581|||<|0.0001|TWO_SIDED|95.0|0.446|0.756||All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.|Regression, Cox|||Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.||0.756|0.446|< 0.0001
91647876|NCT00361257|183188089|SUPERIORITY_OR_OTHER||Slope|0.145|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.||The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
91781509|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|7.89|||<|0.0001|TWO_SIDED|95.0|4.86|10.92|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||10.92|4.86|<0.0001
91781510|NCT01995838|183442463|SUPERIORITY||LS Mean Difference|8.87|||<|0.0001|TWO_SIDED|95.0|5.72|12.02|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||12.02|5.72|<0.0001
91781511|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.77||||0.1407|TWO_SIDED|95.0|0.54|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.09|0.54|0.1407
91588066|NCT01176968|183065487|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.562||||0.6406|TWO_SIDED|95.0|0.05|6.308|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||6.308|0.050|0.6406
91588067|NCT01176968|183065488|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.726||||0.5338|TWO_SIDED|95.0|0.265|1.99|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||1.990|0.265|0.5338
91781512|NCT01995838|183442464|SUPERIORITY|Days 1-2|Geometric Mean Ratio|0.55||||0.0018|TWO_SIDED|95.0|0.38|0.8|||ANCOVA|Baseline value and treatment as covariates.||||0.80|0.38|0.0018
91781513|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.6||||0.0025|TWO_SIDED|95.0|0.43|0.83|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.83|0.43|0.0025
91781514|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.54||||0.0006|TWO_SIDED|95.0|0.38|0.76|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.76|0.38|0.0006
91781515|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.7|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.70|0.38|<0.0001
91588068|NCT01176968|183065490|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.083||||0.8042|TWO_SIDED|95.0|0.575|2.04|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||2.040|0.575|0.8042
91588069|NCT01176968|183065491|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.598||||0.0003|TWO_SIDED|95.0|0.452|0.791|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||0.791|0.452|0.0003
91588070|NCT01176968|183065492|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.069||||0.9353|TWO_SIDED|95.0|0.213|5.371|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||5.371|0.213|0.9353
91588071|NCT01176968|183065493|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.6||||0.3757|TWO_SIDED|95.0|0.566|4.525|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||4.525|0.566|0.3757
91588072|NCT01176968|183065494|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45||||0.1744|TWO_SIDED|95.0|-3.55|0.65|||ANCOVA|||ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.||0.65|-3.55|0.1744
91588073|NCT01176968|183065495|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.7123|TWO_SIDED|95.0|-0.1|0.14||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.14|-0.10|0.7123
91588074|NCT01176968|183065495|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.4105|TWO_SIDED|95.0|-0.05|0.13||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.13|-0.05|0.4105
91588075|NCT01176968|183065496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91588076|NCT01176968|183065496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.5552|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.5552
91709061|NCT03035916|183311324|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91588077|NCT01176968|183065496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||< 0.0001
91588078|NCT01176968|183065496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91588079|NCT01176968|183065496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91588080|NCT01176968|183065496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3347|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.3347
91588081|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0005
91588082|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91709062|NCT03035916|183311324|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91709063|NCT03035916|183311325|OTHER|||||||0.673|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.673
91709064|NCT03035916|183311325|OTHER|||||||0.824|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.824
91781516|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.29|0.54|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2:||0.54|0.29|<0.0001
91588083|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1558|TWO_SIDED||||||Wilcoxon-Rank Sum test|||For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.1558
91588084|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0008
91588085|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91588086|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0293
91588087|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.1723
91588088|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0295|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0295
91588089|NCT01176968|183065497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0865|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0865
91647877|NCT00361257|183188090|SUPERIORITY_OR_OTHER||Slope|-0.126|STANDARD_ERROR_OF_MEAN|0.172||0.467|TWO_SIDED|95.0|-0.467|0.216||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.||The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.||0.216|-0.467|0.467
91781517|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.73||||0.1158|TWO_SIDED|95.0|0.49|1.08|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||1.08|0.49|0.1158
91781518|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.49||||0.001|TWO_SIDED|95.0|0.33|0.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.75|0.33|0.0010
91781519|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.47|||<|0.0001|TWO_SIDED|95.0|0.32|0.69|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.69|0.32|<0.0001
91588090|NCT01176968|183065498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0944
91588091|NCT01176968|183065498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0360
91781520|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.47|0.21|<0.0001
91781521|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.57|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.57|0.29|<0.0001
91781522|NCT01995838|183442464|SUPERIORITY||Geometric Mean Ratio|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.48|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.48|0.24|<0.0001
91588092|NCT01176968|183065498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6459|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.6459
91588093|NCT01176968|183065499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91588094|NCT01176968|183065499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
91588095|NCT01176968|183065499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0801|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0801
91588096|NCT00744523|183065500|SUPERIORITY_OR_OTHER||proportion of the primary endpoint|2.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.05|ONE_SIDED|95.0||5.2|||t-test, 1 sided||"Parameter Dispersion Type of Standard Error of the mean is meant to state that 'mean is the mean of proportions in the sense of a central-limit theorem"|The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).||5.2||<0.05
91588097|NCT03588728|183065532|SUPERIORITY|||||||0.781|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.781
91588098|NCT03588728|183065533|SUPERIORITY|||||||0.409|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.409
91588099|NCT03588728|183065534|SUPERIORITY|||||||0.697|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.697
91588100|NCT03588728|183065535|SUPERIORITY|||||||0.193|||||||ANOVA|P value indicates interaction term.||Test of between subjects effects||||.193
91588101|NCT03588728|183065536|SUPERIORITY|||||||0.185|||||||ANOVA|P value indicates the interaction term||Test of between-subjects effects||||.185
91588102|NCT03588728|183065537|SUPERIORITY|||||||0.198|||||||ANOVA|P value indicates the interaction term||Test of between-measures effects||||.198
91781523|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-11.08||||0.105|TWO_SIDED|95.0|-24.48|2.33|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||2.33|-24.48|0.1050
91781524|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-2.29||||0.7501|TWO_SIDED|95.0|-16.46|11.87|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||11.87|-16.46|0.7501
91781525|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-11.26||||0.0818|TWO_SIDED|95.0|-23.94|1.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.43|-23.94|0.0818
91781526|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-19.81||||0.0038|TWO_SIDED|95.0|-33.18|-6.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-6.43|-33.18|0.0038
91521257|NCT02954354|182917047|SUPERIORITY||Difference|-9.0||||0.0298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.0298
91588103|NCT03588728|183065538|SUPERIORITY|||||||0.638|||||||ANOVA|||Test of between-subjects effects||||.638
91647878|NCT00361257|183188091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.476|STANDARD_DEVIATION|1.048||0.234|TWO_SIDED|95.0|0.575|10.668||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.||"The null hypothesis was that the proportion of being better at 24 weeks in minocycline group was the same as in the placebo group."||10.668|0.575|0.234
91588104|NCT03588728|183065539|SUPERIORITY|||||||0.574|||||||ANOVA|p-value indicates the interaction term||Test of between-subjects effectd||||.574
91588105|NCT03588728|183065540|SUPERIORITY|||||||0.564|||||||ANOVA|P-value indicates the interaction term||Test of between-subjects effects||||.564
91588106|NCT03588728|183065541|SUPERIORITY|||||||0.998|||||||ANOVA|p-value indicates the interaction term||Tests of between-subjects effects||||.998
91588107|NCT03588728|183065542|SUPERIORITY|||||||0.348|||||||ANOVA|P-value indicates the interaction term||Tests of between-subjecs effects||||.348
91588108|NCT01067326|183065603|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Change in EPCs from baseline to 4 months||||0.02
91588109|NCT01067326|183065604|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|||Difference in systolic blood pressure from baseline to 4 months.||||.006
91647879|NCT00361257|183188092|SUPERIORITY_OR_OTHER||Slope|19.09|STANDARD_ERROR_OF_MEAN|33.75||0.574|TWO_SIDED|95.0|-48.26|86.44||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.||The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.||86.44|-48.26|0.574
91521258|NCT02954354|182917047|SUPERIORITY||Difference|-11.8||||0.0297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.0297
91781527|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-29.34|||<|0.0001|TWO_SIDED|95.0|-40.75|17.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||17.93|-40.75|<0.0001
91781528|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-25.84|||<|0.0001|TWO_SIDED|95.0|-37.59|-14.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-14.09|-37.59|<0.0001
91781529|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|0.4642||||0.4642|TWO_SIDED|95.0|-9.6|20.98|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||20.98|-9.60|0.4642
91781530|NCT01995838|183442465|SUPERIORITY|Baseline value and treatment as covariates.|LS Mean Difference|-2.31||||0.7754|TWO_SIDED|95.0|-18.27|13.64|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||13.64|-18.27|0.7754
91781531|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-10.69||||0.1461|TWO_SIDED|95.0|-25.14|3.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.75|-25.14|0.1461
91781532|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-14.73||||0.0581|TWO_SIDED|95.0|-29.97|0.51|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.51|-29.97|0.0581
91781533|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-20.8||||0.0019|TWO_SIDED|95.0|-33.86|-7.74|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.74|-33.86|0.0019
91781534|NCT01995838|183442465|SUPERIORITY||LS Mean Difference|-21.52||||0.002|TWO_SIDED|95.0|-35.12|-7.91|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.91|-35.12|0.0020
91781535|NCT01995838|183442469|SUPERIORITY||LS Mean Difference|-3.05||||0.1483|TWO_SIDED|95.0|-7.2|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.09|-7.20|0.1483
91781536|NCT01995838|183442469|SUPERIORITY||LS Mean Difference|-0.64||||0.772|TWO_SIDED|95.0|-4.96|3.69|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||3.69|-4.96|0.7720
91781537|NCT01995838|183442469|SUPERIORITY||LS Mean Difference|1.5||||0.4548|TWO_SIDED|95.0|-2.44|5.44|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.44|-2.44|0.4548
91781538|NCT01995838|183442469|SUPERIORITY||LS Mean Difference|-2.39||||0.253|TWO_SIDED|95.0|-6.51|1.72|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.72|-6.51|0.2530
91781539|NCT01995838|183442469|SUPERIORITY||LS Mean Difference|2.41||||0.1794|TWO_SIDED|95.0|-1.11|5.93|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.93|-1.11|0.1794
91781540|NCT01995838|183442469|SUPERIORITY||LS Mean Difference|0.94||||0.6148|TWO_SIDED|95.0|-2.74|4.63|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||4.63|-2.74|0.6148
91781541|NCT00346697|183442509|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91781542|NCT00346697|183442510|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||.80
91781543|NCT00346697|183442511|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91781544|NCT00346697|183442512|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91781545|NCT00346697|183442513|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91781546|NCT00346697|183442514|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
91781547|NCT00346697|183442515|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
91781548|NCT00346697|183442516|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
91781549|NCT00346697|183442517|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91781550|NCT00346697|183442518|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91781551|NCT00346697|183442519|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91781552|NCT00346697|183442520|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91781553|NCT00346697|183442521|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91781554|NCT00346697|183442522|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91781555|NCT00346697|183442523|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
91781556|NCT02691507|183442560|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781557|NCT02691507|183442560|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
91781558|NCT02691507|183442560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.795||0.616|TWO_SIDED|95.0|-1.196|1.998||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.998|-1.196|0.616
91781559|NCT02691507|183442561|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781560|NCT02691507|183442561|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91647880|NCT00361257|183188093|SUPERIORITY_OR_OTHER||Slope|40.43|STANDARD_ERROR_OF_MEAN|59.91||0.502|TWO_SIDED|95.0|-79.12|159.97||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.||The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.||159.97|-79.12|0.502
91647881|NCT00361257|183188094|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||Log Rank|||The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.||||0.967
91647882|NCT00361257|183188096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.071|STANDARD_ERROR_OF_MEAN|0.497||0.89|TWO_SIDED|95.0|0.405|2.837||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|The model was adjusted for the stratification variables and the baseline CNS penetration score.||The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.||2.837|0.405|0.890
91647883|NCT00361257|183188097|SUPERIORITY_OR_OTHER||Slope|-0.405|STANDARD_ERROR_OF_MEAN|0.391||0.304|TWO_SIDED|95.0|-1.182|0.373||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.||The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.||0.373|-1.182|0.304
91588110|NCT01067326|183065605|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Difference in diastolic blood pressure from baseline to 4 months.||||0.04
91588111|NCT01067326|183065606|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||P-value for intergroup comparison of change from baseline to month 4||||0.94
91588112|NCT00078754|183065609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANCOVA|||||||0.622
91588113|NCT00078754|183065610|SUPERIORITY|||||||0.029||||||LHA score main effect.|ANCOVA|The LHA Score F\[1,83\] = 4.91, p = 0.029; Condition F\[2,83\] = 0.20, p = 0.815; Condition x LHA Score F\[2,83\] = 0.255, p = 0.799.||The hypothesis was that subjects with LHA Scores = 18 or more would respond better to divalproex (than fluoxetine) while those with LHA scores = or \< 17 would respond better to fluoxetine (than divalproex).||||0.029
91588114|NCT00078754|183065610|SUPERIORITY||Mean Difference (Final Values)|19.0|STANDARD_ERROR_OF_MEAN|2.7||0.8|TWO_SIDED||||||ANCOVA|Baseline OAS-M Aggression score as covariate.||ANCOVA at endpoint with baseline OAS-M AGG score as covariate.||||0.80
91588115|NCT00809523|183065612|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.||||0.007
91588116|NCT00809523|183065613|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
91588117|NCT00986440|183065637|SUPERIORITY||Z statistic for difference|3.92|||<|0.0001|TWO_SIDED||||||2-sided P value for z test|||||||<0.0001
91588118|NCT00986440|183065637|SUPERIORITY||Hazard Ratio, log|-0.41|||||TWO_SIDED|||||||||||||
91647884|NCT00361257|183188102|SUPERIORITY_OR_OTHER||Slope|-0.097|STANDARD_ERROR_OF_MEAN|0.146||0.506|TWO_SIDED|95.0|-0.388|0.193||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.||The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.||0.193|-0.388|0.506
91709065|NCT03035916|183311325|OTHER|||||||0.547|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.547
91588119|NCT00986440|183065638|SUPERIORITY|||||||0.038|||||||Log Rank|||||||0.0380
91588120|NCT00986440|183065638|SUPERIORITY|||||||0.1773|||||||Peto-Peto-Prentice|||||||0.1773
91588121|NCT00986440|183065638|SUPERIORITY|||||||0.2844|||||||Wilcoxon (Mann-Whitney)|||||||0.2844
91588122|NCT00986440|183065638|SUPERIORITY|||||||0.114|||||||Tarone-Ware|||||||0.1140
91588123|NCT00986440|183065639|SUPERIORITY|||||||0.1213|||||||Log Rank|||||||0.1213
91588124|NCT00267631|183065658|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Chi-squared|||||||.026
91588125|NCT02876835|183065694|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.19|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|
91588126|NCT02876835|183065695|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.08|||||TWO_SIDED|95.0|0.03|0.13||||||||0.13|0.03|
91588127|NCT02876835|183065696|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.670884|TWO_SIDED|95.0|0.89|1.19||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|0.670884
91588128|NCT02876835|183065697|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.800813|TWO_SIDED|95.0|0.93|1.22||The p-value was compared against 0.012500 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.93|0.800813
91588129|NCT02876835|183065698|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.886195|TWO_SIDED|95.0|0.95|1.24||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.24|0.95|0.886195
91588130|NCT02876835|183065699|SUPERIORITY||Subdistribution hazard ratio|0.98||||0.36947|TWO_SIDED|95.0|0.84|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.84|0.369470
91588131|NCT02876835|183065700|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6197|TWO_SIDED|95.0|0.87|1.2|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.20|0.87|0.6197
91647885|NCT00361257|183188103|SUPERIORITY_OR_OTHER||Slope|0.146|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.||The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
91647886|NCT00361257|183188104|SUPERIORITY_OR_OTHER||Slope|0.055|STANDARD_ERROR_OF_MEAN|0.137||0.69|TWO_SIDED|95.0|-0.217|0.327||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.||The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.||0.327|-0.217|0.690
91588132|NCT02876835|183065701|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8976|TWO_SIDED|95.0|0.91|1.58|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.58|0.91|0.8976
91588133|NCT02876835|183065702|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6581|TWO_SIDED|95.0|0.8|1.4|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.40|0.80|0.6581
91588134|NCT02876835|183065703|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.894|TWO_SIDED|95.0|0.85|2.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||2.07|0.85|0.8940
91588135|NCT02876835|183065704|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9422|TWO_SIDED|95.0|0.98|1.23|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.23|0.98|0.9422
91588136|NCT02876835|183065704|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
91647887|NCT03471182|183188115|SUPERIORITY|||||||0.035||||||Primary hypothesis of a group difference (i.e., CUD vs HHC-PET participants) in mGluR5 availability was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 9 regions of interest (i.e., all 9 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of region. Group (i.e., CUD, HHC-PET) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the region-by-group interaction term and a factor to model the random-effect of participant.||||0.035
91588137|NCT02876835|183065704|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6789|TWO_SIDED|95.0|0.82|1.39|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.39|0.82|0.6789
91588138|NCT02876835|183065704|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.9016|TWO_SIDED|95.0|0.85|2.19|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||2.19|0.85|0.9016
91588139|NCT02876835|183065704|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
91709066|NCT03035916|183311325|OTHER|||||||0.303|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.303
91709067|NCT03035916|183311325|OTHER|||||||0.026|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.026
91781561|NCT02691507|183442561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.803||0.297|TWO_SIDED|95.0|-0.767|2.46||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.460|-0.767|0.297
91781562|NCT02691507|183442562|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91588140|NCT02876835|183065704|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.8989|TWO_SIDED|95.0|0.92|1.46|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.46|0.92|0.8989
91588141|NCT02876835|183065705|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.7673|TWO_SIDED|95.0|0.88|1.33|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.33|0.88|0.7673
91588142|NCT02876835|183065706|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.8601|TWO_SIDED|95.0|0.96|1.15|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.15|0.96|0.8601
91588143|NCT02876835|183065707|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6207|TWO_SIDED|95.0|0.86|1.22|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.86|0.6207
91588144|NCT02876835|183065708|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.9393|TWO_SIDED|95.0|0.97|1.26|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.26|0.97|0.9393
91588145|NCT02876835|183065709|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.9412|TWO_SIDED|95.0|0.95|1.56|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.56|0.95|0.9412
91588146|NCT02876835|183065710|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.8994|TWO_SIDED|95.0|0.88|1.84|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.84|0.88|0.8994
91588147|NCT02876835|183065711|SUPERIORITY||Subdistribution hazard ratio|0.92||||0.2073|TWO_SIDED|95.0|0.75|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.75|0.2073
91588148|NCT02876835|183065712|SUPERIORITY||Subdistribution hazard ratio|1.0||||0.5068|TWO_SIDED|95.0|0.84|1.19|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.19|0.84|0.5068
91588149|NCT02876835|183065713|SUPERIORITY||Subdistribution hazard ratio|0.88||||0.3285|TWO_SIDED|95.0|0.51|1.54|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.54|0.51|0.3285
91588150|NCT02876835|183065714|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||||0.11|-0.05|
91588151|NCT02876835|183065715|SUPERIORITY||Difference in response rate|8.3|||<|0.0001|TWO_SIDED|95.0|5.2|11.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for current ESA use and region was used to compare the number of responders between the treatment groups.|||11.4|5.2|<0.0001
91588152|NCT02876835|183065716|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Mean Difference (Final Values)|4.57|||||TWO_SIDED|95.0|2.04|7.11|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||7.11|2.04|
91588153|NCT02876835|183065717|SUPERIORITY||Probability|0.55|||<|0.0001|TWO_SIDED|95.0|0.53|0.57|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.57|0.53|<0.0001
91781563|NCT02691507|183442562|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91588154|NCT02876835|183065718|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|3.94|||||TWO_SIDED|95.0|1.9|5.91|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||5.91|1.90|
91588155|NCT02876835|183065719|SUPERIORITY||Probability|0.54|||<|0.0001|TWO_SIDED|95.0|0.52|0.56|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.56|0.52|<0.0001
91588156|NCT02876835|183065720|SUPERIORITY||LS mean difference|0.56||||0.7916|TWO_SIDED|95.0|-0.79|1.9|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.90|-0.79|0.7916
91588157|NCT02876835|183065720|SUPERIORITY||LS mean difference|0.65||||0.9581|TWO_SIDED|95.0|-0.09|1.38|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.38|-0.09|0.9581
91588158|NCT02876835|183065720|SUPERIORITY||LS mean difference|0.6||||0.9241|TWO_SIDED|95.0|-0.22|1.43|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.43|-0.22|0.9241
91588159|NCT02876835|183065721|SUPERIORITY||LS mean difference|-0.08||||0.442|TWO_SIDED|95.0|-1.18|1.02|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||1.02|-1.18|0.4420
91588160|NCT02876835|183065721|SUPERIORITY||LS mean difference|0.11||||0.6369|TWO_SIDED|95.0|-0.52|0.75|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.75|-0.52|0.6369
91588161|NCT02876835|183065721|SUPERIORITY||LS mean difference|0.04||||0.549|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.74|-0.65|0.5490
91588162|NCT02876835|183065722|SUPERIORITY||Ratio of exacerbation rate|0.88||||0.0074|TWO_SIDED|95.0|0.79|0.98|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs estimated using negative binomial model with treatment,current ESA use at randomization and region as covariates and logarithm of time on treatment as offset variable for treatment group comparison.|||0.98|0.79|0.0074
91588163|NCT02876835|183065724|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0113|TWO_SIDED|95.0|0.42|0.94|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, current ESA use and region.|||0.94|0.42|0.0113
91588164|NCT02876835|183065725|SUPERIORITY||LS mean difference|-0.36||||0.932|TWO_SIDED|95.0|-0.83|0.11|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time,current ESA use at randomization, region,Baseline value and Baseline value by time and treatment by time interactions|||0.11|-0.83|0.9320
91588165|NCT02876835|183065725|SUPERIORITY||LS mean difference|-0.11||||0.6761|TWO_SIDED|95.0|-0.59|0.36|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.36|-0.59|0.6761
91588166|NCT02876835|183065725|SUPERIORITY||LS mean difference|0.12||||0.3335|TWO_SIDED|95.0|-0.43|0.67|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.67|-0.43|0.3335
91588167|NCT02876835|183065725|SUPERIORITY||LS mean difference|-0.2||||0.7423|TWO_SIDED|95.0|-0.81|0.41|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.41|-0.81|0.7423
91588168|NCT02876835|183065726|SUPERIORITY||LS mean difference|-0.29||||0.8268|TWO_SIDED|95.0|-0.9|0.32|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions.|||0.32|-0.90|0.8268
91588169|NCT02876835|183065726|SUPERIORITY||LS mean difference|-0.15||||0.6851|TWO_SIDED|95.0|-0.77|0.47|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.47|-0.77|0.6851
91588170|NCT02876835|183065726|SUPERIORITY||LS mean difference|-0.33||||0.8316|TWO_SIDED|95.0|-1.01|0.35|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.35|-1.01|0.8316
91588171|NCT02876835|183065726|SUPERIORITY||LS mean difference|-0.35||||0.8032|TWO_SIDED|95.0|-1.16|0.46|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.46|-1.16|0.8032
91709068|NCT03035916|183311325|OTHER|||||||0.002|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.002
91588172|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.34||||0.8562|TWO_SIDED|95.0|-0.95|0.28|||MMRM||B pain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.28|-0.95|0.8562
91588173|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.15||||0.6849|TWO_SIDED|95.0|-0.77|0.47|||MMRM||B pain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.47|-0.77|0.6849
91588174|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.49||||0.9074|TWO_SIDED|95.0|-1.22|0.24|||MMRM||B pain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.24|-1.22|0.9074
91709069|NCT03035916|183311325|OTHER|||||||0.057|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.057
91588175|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.47||||0.8765|TWO_SIDED|95.0|-1.26|0.32|||MMRM||B pain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.32|-1.26|0.8765
91709070|NCT03035916|183311325|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91588176|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.08||||0.6252|TWO_SIDED|95.0|-0.56|0.4|||MMRM||GH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.40|-0.56|0.6252
91588177|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.2||||0.7852|TWO_SIDED|95.0|-0.68|0.29|||MMRM||GH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.29|-0.68|0.7852
91709071|NCT03035916|183311325|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91521259|NCT02954354|182917047|SUPERIORITY||Difference|-20.7||||0.0027||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal Congestion||||0.0027
91781564|NCT02691507|183442562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.846||0.394|TWO_SIDED|95.0|-0.973|2.426||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.426|-0.973|0.394
91588178|NCT02876835|183065727|SUPERIORITY||LS mean difference|0.1||||0.3614|TWO_SIDED|95.0|-0.46|0.66|||MMRM||GH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.66|-0.46|0.3614
91588179|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.08||||0.5991|TWO_SIDED|95.0|-0.7|0.54|||MMRM||GH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.54|-0.70|0.5991
91588180|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.31||||0.8526|TWO_SIDED|95.0|-0.88|0.27|||MMRM||MH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.27|-0.88|0.8526
91588181|NCT02876835|183065727|SUPERIORITY||LS mean difference|0.02||||0.4673|TWO_SIDED|95.0|-0.56|0.61|||MMRM||MH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.61|-0.56|0.4673
91588182|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.31||||0.8262|TWO_SIDED|95.0|-0.95|0.33|||MMRM||MH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.33|-0.95|0.8262
91588183|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.25||||0.738|TWO_SIDED|95.0|-1.0|0.51|||MMRM||MH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.51|-1.00|0.7380
91588184|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.09||||0.5997|TWO_SIDED|95.0|-0.8|0.62|||MMRM||RE,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.62|-0.80|0.5997
91588185|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.26||||0.7649|TWO_SIDED|95.0|-0.98|0.45|||MMRM||RE,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.45|-0.98|0.7649
91781565|NCT02691507|183442563|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781566|NCT02691507|183442563|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91588186|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.37||||0.8175|TWO_SIDED|95.0|-1.18|0.43|||MMRM||RE,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.18|0.8175
91588187|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.52||||0.8591|TWO_SIDED|95.0|-1.47|0.43|||MMRM||RE,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.47|0.8591
91588188|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.5||||0.9588|TWO_SIDED|95.0|-1.06|0.06|||MMRM||RP,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.06|-1.06|0.9588
91588189|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.33||||0.8761|TWO_SIDED|95.0|-0.9|0.23|||MMRM||RP,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.23|-0.90|0.8761
91588190|NCT02876835|183065727|SUPERIORITY||LS mean difference|0.06||||0.4293|TWO_SIDED|95.0|-0.58|0.7|||MMRM||RP,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.70|-0.58|0.4293
91781567|NCT02691507|183442563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.708||0.69|TWO_SIDED|95.0|-1.14|1.709||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.709|-1.140|0.690
91781568|NCT02691507|183442564|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91647888|NCT03471182|183188116|SUPERIORITY|Outcome Measure Data were tested using a single linear mixed effects model. The 4 brain networks of interest (i.e., all 4 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||||0.024||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in functional brain network engagement was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||||||0.024
91647889|NCT03471182|183188117|SUPERIORITY|||||||0.87||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in fALFF was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 5 brain networks of interest (i.e., all 5 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||0.870
91647890|NCT00289731|183188132|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.66|||||TWO_SIDED|95.0|-5.34|1.48||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.48|-5.34|
91647891|NCT00289731|183188132|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.63|||||TWO_SIDED|95.0|-5.31|1.6||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.60|-5.31|
91647892|NCT00289731|183188133|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%.|Difference in seroprotection rate|12.04|||||TWO_SIDED|95.0|4.97|19.35||||||Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.||19.35|4.97|
91781569|NCT02691507|183442564|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91588191|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.19||||0.6983|TWO_SIDED|95.0|-0.92|0.53|||MMRM||RP,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.53|-0.92|0.6983
91588192|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.62||||0.9743|TWO_SIDED|95.0|-1.25|0.0|||MMRM||SF,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.00|-1.25|0.9743
91781570|NCT02691507|183442564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.735||0.914|TWO_SIDED|95.0|-1.556|1.397||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.397|-1.556|0.914
91781571|NCT02691507|183442565|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781572|NCT02691507|183442565|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91588193|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.32||||0.8405|TWO_SIDED|95.0|-0.94|0.31|||MMRM||SF,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.31|-0.94|0.8405
91709072|NCT03035916|183311325|OTHER|||||||0.069|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.069
91709073|NCT03035916|183311325|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91588194|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.13||||0.6459|TWO_SIDED|95.0|-0.82|0.56|||MMRM||SF,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.56|-0.82|0.6459
91647893|NCT00289731|183188133|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%.|Difference in seroprotection rates|20.69|||||TWO_SIDED|95.0|12.92|28.62||||||Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.||28.62|12.92|
91647894|NCT02314520|183188161|SUPERIORITY|||||||0.271||||||0.05 is the threshold for significance for this primary outcome.|Fisher Exact|||||||0.271
91647895|NCT00661674|183188165|SUPERIORITY_OR_OTHER|||||||0.0001||||||p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.0001
91647896|NCT00661674|183188166|SUPERIORITY_OR_OTHER|||||||0.2244||||||p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.2244
91588195|NCT02876835|183065727|SUPERIORITY||LS mean difference|-0.38||||0.8272|TWO_SIDED|95.0|-1.17|0.41|||MMRM||SF,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.41|-1.17|0.8272
91647897|NCT00660790|183188167|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||The paired student's t-test or the Wilcoxon signed-rank test was used to compare the measurements before and after multifactorial treatment, as appropriate, depending on the distribution of the data.||||0.021
91647898|NCT00423488|183188280|SUPERIORITY_OR_OTHER_LEGACY||least-squares means|-11.5||||0.005||95.0|-19.4|-3.5|||ANOVA|The analysis of variance (ANOVA) model included term of treatment effect. If more than one basal value was available, the latest was used.||||-3.5|-19.4|0.005
91647899|NCT03118765|183188281|OTHER|ANOVA|LS mean ratio (%)|29.4|||||TWO_SIDED|90.0|21.14|41.0|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||41.00|21.14|
91647900|NCT03118765|183188281|OTHER|ANOVA|LS mean ratio (%)|57.0|||||TWO_SIDED|90.0|41.37|78.46|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||78.46|41.37|
91647901|NCT03118765|183188281|OTHER|ANOVA|LS mean ratio (%)|155.8|||||TWO_SIDED|90.0|111.88|216.99|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||216.99|111.88|
91647902|NCT03118765|183188282|OTHER|ANOVA|LS mean ratio (%)|39.7|||||TWO_SIDED|90.0|29.79|52.87|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||52.87|29.79|
91647903|NCT03118765|183188282|OTHER|ANOVA|LS mean ratio (%)|85.2|||||TWO_SIDED|90.0|64.43|112.64|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||112.64|64.43|
91647904|NCT03118765|183188282|OTHER|ANOVA|LS mean ratio (%)|211.5|||||TWO_SIDED|90.0|158.8|281.8|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||281.80|158.80|
91647905|NCT03118765|183188283|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.228|TWO_SIDED|95.0|-0.04|0.17|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.17|-0.04|0.228
91588196|NCT02876835|183065728|SUPERIORITY||LS mean difference|-0.56||||0.9786|TWO_SIDED|95.0|-1.09|-0.02|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||-0.02|-1.09|0.9786
91588197|NCT02876835|183065728|SUPERIORITY||LS mean difference|-0.12||||0.6642|TWO_SIDED|95.0|-0.68|0.44|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.44|-0.68|0.6642
91588198|NCT02876835|183065728|SUPERIORITY||LS mean difference|-0.1||||0.6261|TWO_SIDED|95.0|-0.72|0.52|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.52|-0.72|0.6261
91588199|NCT02876835|183065728|SUPERIORITY||LS mean difference|-0.49||||0.9161|TWO_SIDED|95.0|-1.19|0.21|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.21|-1.19|0.9161
91588200|NCT02876835|183065729|SUPERIORITY||LS mean difference|-0.32||||0.8703|TWO_SIDED|95.0|-0.88|0.24|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.24|-0.88|0.8703
91588201|NCT02876835|183065729|SUPERIORITY||LS mean difference|0.13||||0.3167|TWO_SIDED|95.0|-0.41|0.67|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.67|-0.41|0.3167
91588202|NCT02876835|183065729|SUPERIORITY||LS mean difference|0.15||||0.3155|TWO_SIDED|95.0|-0.47|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.78|-0.47|0.3155
91588203|NCT02876835|183065729|SUPERIORITY||LS mean difference|-0.32||||0.8069|TWO_SIDED|95.0|-1.06|0.41|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.41|-1.06|0.8069
91588204|NCT02876835|183065730|SUPERIORITY||LS mean difference|-0.0234||||0.9724|TWO_SIDED|95.0|-0.0474|0.0005|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0005|-0.0474|0.9724
91588205|NCT02876835|183065731|SUPERIORITY||LS mean difference|0.7||||0.2687|TWO_SIDED|95.0|-1.5|2.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||2.9|-1.5|0.2687
91588206|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.22||||0.978|TWO_SIDED|95.0|-2.4|-0.03|||MMRM||Tired/LE/Weak domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.40|0.9780
91588207|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.97||||0.943|TWO_SIDED|95.0|-2.18|0.23|||MMRM||Tired/LE/Weak domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.23|-2.18|0.9430
91588208|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.6||||0.8042|TWO_SIDED|95.0|-1.98|0.77|||MMRM||Tired/LE/Weak domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.77|-1.98|0.8042
91588209|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.57||||0.977|TWO_SIDED|95.0|-3.11|-0.03|||MMRM||Tired/LE/Weak domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-3.11|0.9770
91588210|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.2||||0.9905|TWO_SIDED|95.0|-2.2|-0.2|||MMRM||CP/SOB,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.20|-2.20|0.9905
91588211|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.65||||0.8939|TWO_SIDED|95.0|-1.67|0.37|||LS mean difference||CP/SOB,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.37|-1.67|0.8939
91588212|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.52||||0.807|TWO_SIDED|95.0|-1.7|0.66|||MMRM||CP/SOB,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.66|-1.70|0.8070
91588213|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.18||||0.9615|TWO_SIDED|95.0|-2.49|0.13|||MMRM||CP/SOB,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.13|-2.49|0.9615
91588214|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.76||||0.9015|TWO_SIDED|95.0|-1.91|0.39|||MMRM||Cog domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.39|-1.91|0.9015
91647906|NCT03118765|183188283|SUPERIORITY||Mean Difference (Net)|0.02||||0.655|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.13|-0.08|0.655
91781573|NCT02691507|183442565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.774||0.757|TWO_SIDED|95.0|-1.796|1.314||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.314|-1.796|0.757
91781574|NCT02691507|183442566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781575|NCT02691507|183442566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781576|NCT02691507|183442566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.798||0.556|TWO_SIDED|95.0|-2.075|1.129||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.129|-2.075|0.556
91521260|NCT02954354|182917047|SUPERIORITY||Difference|-4.9||||0.0003||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||Feverishness or chills||||0.0003
91588215|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.18||||0.9781|TWO_SIDED|95.0|-2.32|-0.03|||MMRM||Cog domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.32|0.9781
91588216|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.77||||0.8778|TWO_SIDED|95.0|-2.07|0.53|||MMRM||Cog domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.53|-2.07|0.8778
91647907|NCT03118765|183188283|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.894|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.11|-0.10|0.894
91781577|NCT02691507|183442567|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781578|NCT02691507|183442567|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781579|NCT02691507|183442567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.772||0.106|TWO_SIDED|95.0|-2.824|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-2.824|0.106
91781580|NCT02691507|183442568|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781581|NCT02691507|183442568|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91647908|NCT03118765|183188283|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.26|TWO_SIDED|95.0|-0.04|0.16|||MMRM|||SPIRIVA RESPIMAT 5 μg vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.16|-0.04|0.260
91781582|NCT02691507|183442568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.83|STANDARD_ERROR_OF_MEAN|6.681|<|0.001|TWO_SIDED|95.0|13.407|40.247||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||40.247|13.407|<0.001
91781583|NCT02691507|183442569|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781584|NCT02691507|183442569|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
91781585|NCT02691507|183442569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.33|STANDARD_ERROR_OF_MEAN|3.996|<|0.001|TWO_SIDED|95.0|11.301|27.352||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||27.352|11.301|<0.001
91781586|NCT02691507|183442570|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781587|NCT02691507|183442570|SUPERIORITY_OR_OTHER|||||||0.009||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.009
91781588|NCT02691507|183442570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.01|STANDARD_ERROR_OF_MEAN|4.072|<|0.001|TWO_SIDED|95.0|7.829|24.187||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.187|7.829|<0.001
91781589|NCT02691507|183442571|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781590|NCT02691507|183442571|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
91781591|NCT02691507|183442571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.25|STANDARD_ERROR_OF_MEAN|3.764|<|0.001|TWO_SIDED|95.0|5.684|20.82||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||20.820|5.684|<0.001
91647909|NCT03118765|183188284|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 10 μg was (Geo mean: 108200 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
91781592|NCT02691507|183442572|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781593|NCT02691507|183442572|SUPERIORITY_OR_OTHER|||||||0.049||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.049
91781594|NCT02691507|183442572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.08|STANDARD_ERROR_OF_MEAN|4.138||0.001|TWO_SIDED|95.0|5.766|22.387||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||22.387|5.766|0.001
91781595|NCT02691507|183442573|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781596|NCT02691507|183442573|SUPERIORITY_OR_OTHER|||||||0.024||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.024
91781597|NCT02691507|183442573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.26|STANDARD_ERROR_OF_MEAN|4.679||0.004|TWO_SIDED|95.0|4.862|23.66||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||23.660|4.862|0.004
91781598|NCT02691507|183442574|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91781599|NCT02691507|183442574|SUPERIORITY_OR_OTHER|||||||0.015||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.015
91588217|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.65||||0.9864|TWO_SIDED|95.0|-3.11|-0.19|||MMRM||Cog domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.19|-3.11|0.9864
91588218|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.1||||0.9725|TWO_SIDED|95.0|-2.3|0.0|||MMRM||SOB, no activity,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.3|0.9725
91588219|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.3||||0.7188|TWO_SIDED|95.0|-1.5|0.8|||MMRM||SOB, no activity,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.8|-1.5|0.7188
91588220|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.9||||0.8903|TWO_SIDED|95.0|-2.3|0.5|||MMRM||SOB, no activity,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.5|-2.3|0.8903
91588221|NCT02876835|183065732|SUPERIORITY||LS mean difference|0.0||||0.5011|TWO_SIDED|95.0|-1.6|1.6|||MMRM||SOB, no activity,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.6|-1.6|0.5011
91588222|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.1||||0.9716|TWO_SIDED|95.0|-2.2|0.0|||MMRM||S-SB,Resting, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.2|0.9716
91588223|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.3||||0.6908|TWO_SIDED|95.0|-1.4|0.9|||MMRM||S-SB,Resting, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.4|0.6908
91588224|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.5||||0.7462|TWO_SIDED|95.0|-1.8|0.9|||MMRM||S-SB,Resting, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.8|0.7462
91588225|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.5||||0.977|TWO_SIDED|95.0|-2.9|0.0|||MMRM||S-SB,Resting, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.9|0.9770
91588226|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.4||||0.9471|TWO_SIDED|95.0|-3.2|0.3|||MMRM||Diff std for LT, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.3|-3.2|0.9471
91588227|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.9||||0.833|TWO_SIDED|95.0|-2.6|0.9|||MMRM||Diff std for LT, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-2.6|0.8330
91588228|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.2||||0.8918|TWO_SIDED|95.0|-3.2|0.7|||MMRM||Diff std for LT, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.7|-3.2|0.8918
91588229|NCT02876835|183065732|SUPERIORITY||LS mean difference|-3.2||||0.9986|TWO_SIDED|95.0|-5.4|-1.1|||MMRM||Diff std for LT, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-1.1|-5.4|0.9986
91781600|NCT02691507|183442574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|4.222||0.004|TWO_SIDED|95.0|4.291|21.252||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.252|4.291|0.004
91781601|NCT02691507|183442575|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91588230|NCT02876835|183065732|SUPERIORITY||LS mean difference|0.4||||0.3035|TWO_SIDED|95.0|-1.2|2.1|||MMRM||Diff sleep, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||2.1|-1.2|0.3035
91588231|NCT02876835|183065732|SUPERIORITY||LS mean difference|-1.4||||0.9563|TWO_SIDED|95.0|-3.1|0.2|||MMRM||Diff sleep, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.2|-3.1|0.9563
91588232|NCT02876835|183065732|SUPERIORITY||LS mean difference|-0.4||||0.6548|TWO_SIDED|95.0|-2.3|1.5|||MMRM||Diff sleep, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.5|-2.3|0.6548
91588233|NCT02876835|183065732|SUPERIORITY||LS mean difference|-2.4||||0.9832|TWO_SIDED|95.0|-4.5|-0.2|||MMRM||Diff sleep, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.2|-4.5|0.9832
91781602|NCT02691507|183442575|SUPERIORITY_OR_OTHER|||||||0.034||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.034
91647910|NCT03118765|183188284|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 20 μg was (Geo mean: 263100 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
91588234|NCT02876835|183065733|SUPERIORITY||LS mean difference|0.02||||0.6917|TWO_SIDED|95.0|-0.05|0.08|||MMRM||Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week 8 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.08|-0.05|0.6917
91588235|NCT02876835|183065733|SUPERIORITY||LS mean difference|0.05||||0.951|TWO_SIDED|95.0|-0.01|0.11|||MMRM||Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week 12 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.11|-0.01|0.9510
91588236|NCT02876835|183065733|SUPERIORITY||LS mean difference|-0.04||||0.1136|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week 28 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1136
91588237|NCT02876835|183065733|SUPERIORITY||LS mean difference|0.05||||0.8859|TWO_SIDED|95.0|-0.03|0.13|||MMRM||Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week 52 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.13|-0.03|0.8859
91588238|NCT02876835|183065734|SUPERIORITY||LS mean difference|-0.2||||0.7716|TWO_SIDED|95.0|-0.74|0.33|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use at randomization, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.33|-0.74|0.7716
91588239|NCT02979925|183065736|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||||||0.246
91588240|NCT02979925|183065737|SUPERIORITY|||||||0.651|||||||Mixed Models Analysis|||||||0.651
91709074|NCT03035916|183311325|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91647911|NCT03118765|183188284|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 40 μg was (Geo mean: 438300 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
91781603|NCT02691507|183442575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.71|STANDARD_ERROR_OF_MEAN|5.925||0.037|TWO_SIDED|95.0|0.805|24.621||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.621|0.805|0.037
91588241|NCT02979925|183065738|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
91588242|NCT05245097|183065739|OTHER|For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully conditional specification (FCS) discriminant function method will be used to impute missing primary endpoint using the baseline covariates of age, sex, race, ethnicity, mobility level, and BIMS Score. The FCS logistic method was replaced with the FCS discriminant function method due to a quasi-separation caused by only one observed primary endpoint event in the treatment group.||||||0.004||||||The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score.|Regression, Logistic|||||||0.004
91709075|NCT03035916|183311325|OTHER|||||||0.561|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.561
91588243|NCT05245097|183065740|OTHER|||||||0.003||||||The hip fracture due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|||||||0.003
91588244|NCT05245097|183065740|SUPERIORITY|||||||0.003|||||||Regression, Logistic|||||||0.003
91588245|NCT05245097|183065741|SUPERIORITY|||||||0.001||||||The emergency department visit due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple ED visits due to falls are only counted once.||||||0.001
91588246|NCT05245097|183065742|SUPERIORITY|||||||0.003||||||The hospitalization due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple hospitalizations due to falls are only counted once.||||||0.003
91588247|NCT00692978|183065767|EQUIVALENCE|Log transformed parametric ANOVA|||||<|0.05||||||calculated|ANOVA|||||||<0.05
91588248|NCT05461794|183065772|OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.3|23.9|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||23.9|0.3|
91588249|NCT05461794|183065772|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-9.3|19.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||19.5|-9.3|
91647912|NCT03118765|183188285|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 10 μg was (Geo mean: 293700 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
91647913|NCT03118765|183188285|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 20 μg was (Geo mean: 436500 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
91647914|NCT03118765|183188285|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 40 μg was (Geo mean: 1249000 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
91647915|NCT03118765|183188286|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 1.082% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
91709076|NCT03035916|183311325|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91588250|NCT05461794|183065774|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.45|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||1.61|0.45|
91588251|NCT05461794|183065775|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.9|6.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||6.8|0.9|
91588252|NCT05461794|183065775|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||3.7|0.3|
91588253|NCT05461794|183065775|OTHER||Risk Difference (RD)|22.0|||||TWO_SIDED|95.0|-1.5|43.3|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||43.3|-1.5|
91588254|NCT05461794|183065775|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-24.5|28.4|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||28.4|-24.5|
91588255|NCT05461794|183065776|OTHER||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|0.7|40.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||40.8|0.7|
91588256|NCT05461794|183065776|OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.1|2.9|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||2.9|0.1|
91588257|NCT05461794|183065776|OTHER||Risk Difference (RD)|12.7|||||TWO_SIDED|95.0|-2.3|29.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||29.5|-2.3|
91588258|NCT05461794|183065776|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-34.7|13.8|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||13.8|-34.7|
91588259|NCT05461794|183065777|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.29|0.96|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||0.96|0.29|
91588260|NCT05461794|183065777|OTHER||Hazard Ratio (HR)|1.96|||||TWO_SIDED|95.0|0.79|4.82|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||4.82|0.79|
91588261|NCT05461794|183065778|OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.1|2.7|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||2.7|0.1|
91647916|NCT03118765|183188286|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 1.316% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
91588262|NCT02083705|183065780|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||"We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \<33 weeks of gestation.~For this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG."||||0.05
91588263|NCT00467285|183065796|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||comparison of changes in BMD at 6months compared to baseline||||<0.05
91588264|NCT03891524|183065831|OTHER|||||||0.0004|||||||MCP-mod analysis|||||||0.0004
91588265|NCT03891524|183065832|OTHER|||||||0.7188|||||||MCP-MOD analysis|||||||0.7188
91588266|NCT03019796|183065839|OTHER|||||||0.04|||||||ANOVA|repeated measures||||||0.040
91588267|NCT03019796|183065840|OTHER|||||||0.054|||||||ANOVA|repeated measures||||||0.054
91588268|NCT03019796|183065841|OTHER|||||||0.04|||||||ANOVA|REPEATED MEASURES||||||0.040
91588269|NCT03019796|183065842|OTHER|||||||0.321|||||||ANOVA|REPEATED MEASURES||||||0.321
91588270|NCT03019796|183065843|OTHER|||||||0.401|||||||ANOVA|REPEATED MEASURES||||||0.401
91588271|NCT03019796|183065844|OTHER|||||||0.021|||||||ANOVA|REPEATED MEASURES||||||0.021
91588272|NCT01389765|183065890|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.01|||||TWO_SIDED|90.0|0.97|1.05|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatment states (fed/fasted), and the 90% confidence interval for the ratio.||||1.05|0.97|
91588273|NCT01389765|183065891|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatments states (fed/fasted), and the 90% confidence interval for the ratio.||||1.01|0.92|
91588274|NCT01389765|183065892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.0031|TWO_SIDED|90.0|0.5|1.5|||Wilcoxon (Mann-Whitney)|Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.||||1.50|0.50|0.0031
91588275|NCT00475033|183065893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.4|||||TWO_SIDED|95.0|-5.3|-0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||-0.1|-5.3|
91588276|NCT00475033|183065894|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Ratio of GMs (13vPnC, 7vPnC)||1.48|0.96|
91588277|NCT00475033|183065895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.6|1.7|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.7|-1.6|
91647917|NCT03118765|183188286|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 1.096% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
91647918|NCT03118765|183188287|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 2.937% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
91647919|NCT03118765|183188287|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 2.183% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
91588278|NCT00475033|183065895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.3|-1.3|
91588279|NCT00475033|183065895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|1.1|||||TWO_SIDED|95.0|-1.7|4.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||4.2|-1.7|
91781604|NCT03739203|183442623|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.88||0.6798|TWO_SIDED|95.0|-2.1|1.37||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||1.37|-2.10|0.6798
91588280|NCT00475033|183065895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.1|||||TWO_SIDED|95.0|-5.5|1.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage||1.2|-5.5|
91781605|NCT03739203|183442623|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1245|TWO_SIDED|95.0|-3.11|0.38||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.38|-3.11|0.1245
91588281|NCT00475033|183065896|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.4|-1.4|
91588282|NCT00475033|183065897|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.27|||||TWO_SIDED|95.0|1.08|1.5|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)||1.50|1.08|
91588283|NCT00475033|183065902|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.14|||||TWO_SIDED|95.0|1.02|1.27|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PT: Ratio of geometric means (13vPnC, 7vPnC)||1.27|1.02|
91588284|NCT00475033|183065902|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12|||||TWO_SIDED|95.0|1.01|1.25|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FHA: Ratio of geometric means (13vPnC, 7vPnC)||1.25|1.01|
91588285|NCT00475033|183065902|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.89|1.24|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRN: Ratio of geometric means (13vPnC, 7vPnC)||1.24|0.89|
91588286|NCT00475033|183065902|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FIM: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.78|
91647920|NCT03118765|183188287|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 3.123% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
91781606|NCT03739203|183442624|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.5152|TWO_SIDED|95.0|-0.29|0.15||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.15|-0.29|0.5152
91781607|NCT03739203|183442624|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0573|TWO_SIDED|95.0|-0.43|0.01||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.01|-0.43|0.0573
91781608|NCT02592798|183442625|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-46.8|33.3|||||Abatacept - Placebo for Double-Blind Period Day 113|||33.3|-46.8|
91781609|NCT02592798|183442625|SUPERIORITY||Mean Difference (Final Values)|-20.8|||||TWO_SIDED|95.0|-63.3|24.3|||||Abatacept - Placebo for Open Label Period Day 113|||24.3|-63.3|
91781610|NCT02592798|183442626|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-1.6495|2.3855|||||Abatacept - Placebo for Double-Blind Period Day 113|||2.3855|-1.6495|
91781611|NCT02592798|183442626|SUPERIORITY||Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-1.7933|5.6954|||||Abatacept - Placebo for Open Label Period Day 113|||5.6954|-1.7933|
91781612|NCT02592798|183442627|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.1483|0.4119|||||Abatacept - Placebo for Double-Blind Period Day 113|||0.4119|-0.1483|
91781613|NCT02592798|183442627|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.5107|0.7551|||||Abatacept - Placebo for Open Label Period Day 113|||0.7551|-0.5107|
91781614|NCT02592798|183442628|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-44.7|44.7|||||Abatacept - Placebo for Open Label Period Day 113|||44.7|-44.7|
91781615|NCT02592798|183442629|SUPERIORITY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-8.1395|6.7645|||||Abatacept - Placebo for Fatigue|||6.7645|-8.1395|
91588287|NCT00475033|183065903|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-1.8|||||TWO_SIDED|95.0|-4.4|0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||0.1|-4.4|
91588288|NCT00475033|183065904|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.75|1.12|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)||1.12|0.75|
91588289|NCT00475033|183065905|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-3.0|||||TWO_SIDED|95.0|-9.4|3.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||3.4|-9.4|
91588290|NCT03645954|183065914|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||<0.01
91588291|NCT03645954|183065915|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
91588292|NCT03645954|183065916|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
91588293|NCT03645954|183065917|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
91647921|NCT03118765|183188288|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean Cmax of tiotropium was 2.191 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
91588294|NCT03645954|183065918|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
91588295|NCT03645954|183065919|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
91588296|NCT01598311|183065929|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in adjusted percentage of cured subjects was \> -10%.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-4.9|7.6||||||||7.6|-4.9|
91588297|NCT01598311|183065931|SUPERIORITY|Superiority was declared if the lower bound of the 95% CI of the adjusted difference in sustained response was \> 0.|Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-3.6|12.2||||||||12.2|-3.6|
91588298|NCT04223856|183065942|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.377|0.538||P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.|Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.538|0.377|<0.00001
91588299|NCT04223856|183065943|SUPERIORITY|P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.|Hazard Ratio (HR)|0.468|||<|1e-05|TWO_SIDED|95.0|0.376|0.582|||Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.582|0.376|<0.00001
91588300|NCT00523718|183065967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||||||.24
91588301|NCT02217436|183065973|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
91588302|NCT02217436|183065974|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91588303|NCT02656420|183065975|EQUIVALENCE|Statistical significance of the treatment effect (p \< 0.01) for the lower doses compared to the high dose as the reference.|Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.89|-1.57||Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).|Mixed Models Analysis|||The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.||-1.57|-1.89|<0.001
91588304|NCT02656420|183065976|SUPERIORITY|To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.|Mean Difference (Final Values)|63.2|||<|0.05|TWO_SIDED|95.0|10.6|140.9|||Regression, Linear||This Estimation Parameter was based on the comparison between the full dose group and the placebo group.|All broccoli sprout arms were compared with the placebo arm.||140.9|10.6|<0.05
91588305|NCT04533451|183065982|SUPERIORITY|||||||0.0385|||||||Log Rank|||||||0.0385
91588306|NCT04533451|183065984|EQUIVALENCE|Relatively large sample size and groups are independent.||||||0.9829|||||||Chi-squared|||||||0.9829
91588307|NCT05344092|183065986|OTHER|Wilcoxon signed rank test comparing baseline score to post-mobile app intervention score (approximately 4 week) for the VetEd Mobile Application user group.|Median Difference (Net)|-0.84||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.40
91647922|NCT03118765|183188288|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean Cmax of tiotropium was 4.796 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
91647923|NCT03118765|183188288|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean Cmax of tiotropium was 10.2 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
91647924|NCT03118765|183188289|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean AUC0-tau of tiotropium was 8.597 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
91647925|NCT03118765|183188289|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean AUC0-tau of tiotropium was 18.00 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
91588308|NCT05344092|183065988|OTHER|Wilcoxon Signed Rank test comparing baseline score to post-mobile app use score (approximately Week 4) for users of the VetEd mobile app.|Median Difference (Net)|-0.11||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.92
91588309|NCT05344092|183065989|OTHER|Wilcoxon Signed Rank test comparing baseline score to post-mobile app use score (approximately Week 4) for users of the VetEd mobile app.|Median Difference (Net)|-0.42||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.68
91588310|NCT02634346|183065990|SUPERIORITY||Least square mean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|-10.0|-2.8|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-2.8|-10.0|<0.001
91588311|NCT02634346|183065990|SUPERIORITY||Least square mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.84||0.004|TWO_SIDED|95.0|-8.9|-1.7|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-1.7|-8.9|0.004
91588312|NCT02634346|183065991|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.118||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.14|-0.61|0.002
91588313|NCT02634346|183065991|SUPERIORITY||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.118|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.20|-0.67|<0.001
91588314|NCT03153137|183066051|SUPERIORITY|For each stage, the p-value from the ANCOVA model including randomized treatment, geographical region, and baseline peak VO2 was used to construct the final adjusted p-value.|Median unbiased estimate and repeated CI|0.62|||=|0.193|TWO_SIDED|99.0|-0.62|1.85||Final adjusted p-value (from weighted inverse normal combination test)|ANCOVA|||Due to adaptive nature of the design, the main analysis was conducted on FAS using the inverse normal combination method with pre-specified weights to combine first and second stage p-values.||1.85|-0.62|= 0.1930
91588315|NCT01821378|183066078|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.255|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||||2.2|-8.4|0.255
91647926|NCT03118765|183188289|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean AUC0-tau of tiotropium was 42.69 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
91588316|NCT01821378|183066078|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.3|||<|-0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|||||-5.7|-14.9|<-0.001
91588317|NCT01821378|183066079|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.169|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||||0.09|-0.49|0.169
91588318|NCT01821378|183066079|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.32|||Mixed Models Analysis|||||-0.32|-0.83|<0.001
91588319|NCT01821378|183066080|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.3||||0.706|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA|||||1.2|-1.8|0.706
91588320|NCT01821378|183066080|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.0||||0.003|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|||||-0.7|-3.3|0.003
91588321|NCT01821378|183066081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.173|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||||2.5|0.8|0.173
91588322|NCT01821378|183066081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|2.0|5.2|||Regression, Logistic|||||5.2|2.0|<0.001
91588323|NCT01821378|183066082|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.7||||0.023|TWO_SIDED|95.0|-14.3|-1.1|||Mixed Models Analysis|||||-1.1|-14.3|0.023
91588324|NCT01821378|183066083|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.8||||0.464|TWO_SIDED|95.0|-2.9|1.3|||ANCOVA|||||1.3|-2.9|0.464
91588325|NCT01821378|183066083|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.8||||0.122|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|||||0.5|-4.1|0.122
91588326|NCT01821378|183066084|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||0.258|TWO_SIDED|95.0|-1.7|6.2|||Mixed Models Analysis|||||6.2|-1.7|0.258
91588327|NCT01821378|183066084|SUPERIORITY_OR_OTHER||Slope|6.6|||<|0.001|TWO_SIDED|95.0|3.2|10.1|||Mixed Models Analysis|||||10.1|3.2|<0.001
91588328|NCT01821378|183066085|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.35||||0.052|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.00|-0.70|0.052
91588329|NCT01821378|183066086|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.084||||0.012|TWO_SIDED|95.0|0.018|0.149|||ANCOVA|||||0.149|0.018|0.012
91588330|NCT01821378|183066086|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.138|||<|0.001|TWO_SIDED|95.0|0.081|0.194|||ANCOVA|||||0.194|0.081|<0.001
91588331|NCT01821378|183066087|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.992|TWO_SIDED|95.0|-6.6|6.6|||Mixed Models Analysis|||||6.6|-6.6|0.992
91588332|NCT01821378|183066087|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.3||||0.044|TWO_SIDED|95.0|-14.4|-0.2|||Mixed Models Analysis|||||-0.2|-14.4|0.044
91588333|NCT01821378|183066088|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.578|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||||0.25|-0.45|0.578
91588334|NCT01821378|183066088|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.58||||0.003|TWO_SIDED|95.0|-0.96|-0.2|||Mixed Models Analysis|||||-0.20|-0.96|0.003
91588335|NCT00195507|183066089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.64|-0.43|||ANCOVA|Treatment and center as main effects, and baseline score as a covariant.||||-0.43|-0.64|<0.001
91647927|NCT03118765|183188292|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean CavSS was 0.9536 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
91647928|NCT03118765|183188292|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean CavSS was 1.998 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
91588336|NCT00195507|183066090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91588337|NCT00195507|183066092|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||||||0.143
91647929|NCT03118765|183188292|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean CavSS was 5.083 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
91647930|NCT03118765|183188293|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.617 for GSP304 10 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
91588338|NCT01106404|183066108|SUPERIORITY_OR_OTHER||binomial proportion|0.865|||<|0.001|ONE_SIDED|97.5|0.765||||Fisher Exact||In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|"ITT analysis:~Hypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p \> 0.25"|||0.765|< 0.001
91588339|NCT01106404|183066108|SUPERIORITY_OR_OTHER||binomial proportion|0.901|||<|0.001|ONE_SIDED|97.5|0.807||||Fisher Exact||In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|Completed case analysis|||0.807|< 0.001
91588340|NCT01106404|183066109|SUPERIORITY_OR_OTHER||binomial proportion|0.028|||||TWO_SIDED|95.0|0.003|0.098|||||The combined percentage of subjects with worsened pain relief was reported.|||0.098|0.003|
91588341|NCT01106404|183066110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.8|STANDARD_DEVIATION|51.9|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
91588342|NCT01106404|183066111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_DEVIATION|1.93|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
91588343|NCT01106404|183066111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.04|<|0.001|TWO_SIDED|95.0|||||Wilcoxon signed rank test|||||||< 0.001
91588344|NCT03027557|183066126|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
91588345|NCT03027557|183066127|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
91588346|NCT03027557|183066128|SUPERIORITY||||||=|0.0019|||||||ANOVA|||||||= 0.0019
91588347|NCT03027557|183066129|SUPERIORITY||||||=|0.096|||||||ANOVA|||||||= 0.096
91588348|NCT03027557|183066130|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
91588349|NCT03027557|183066131|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
91588350|NCT03027557|183066132|SUPERIORITY||||||=|0.0027|||||||ANOVA|||||||= 0.0027
91588351|NCT03027557|183066133|SUPERIORITY||||||=|0.081|||||||ANOVA|||||||= 0.081
91588352|NCT03027557|183066134|SUPERIORITY||||||=|0.0071|||||||ANOVA|||||||= 0.0071
91588353|NCT03027557|183066135|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
91588354|NCT03027557|183066136|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
91588355|NCT03027557|183066137|SUPERIORITY||||||=|0.38|||||||Kruskal-Wallis|||||||= 0.38
91588356|NCT03027557|183066142|SUPERIORITY||||||=|0.83|||||||Kruskal-Wallis|||||||= 0.83
91588357|NCT03027557|183066145|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
91588358|NCT03027557|183066146|SUPERIORITY||||||=|0.0077|||||||ANOVA|||||||= 0.0077
91588359|NCT03027557|183066147|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
91588360|NCT03027557|183066148|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
91588361|NCT03027557|183066149|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
91588362|NCT03027557|183066150|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
91588363|NCT03027557|183066151|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
91588364|NCT03027557|183066152|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
91588365|NCT03027557|183066153|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
91588366|NCT03027557|183066155|SUPERIORITY||||||=|0.5|||||||Kruskal-Wallis|||||||= 0.5
91588367|NCT03027557|183066156|SUPERIORITY||||||=|0.85|||||||ANOVA|||||||= 0.85
91588368|NCT03027557|183066157|SUPERIORITY||||||=|0.22|||||||ANOVA|||||||= 0.22
91588369|NCT03027557|183066158|SUPERIORITY||||||=|0.18|||||||Kruskal-Wallis|||||||= 0.18
91588370|NCT02430051|183066163|SUPERIORITY|||||||0.01|||||||Mixed-effects regression model|Adjusted for attained age and first or second clinic visit.||||||0.01
91588371|NCT02430051|183066164|SUPERIORITY|||||||0.25|||||||Mixed-effects regression model|Adjustment for attained age and first and second clinic visit.||||||0.25
91588372|NCT02430051|183066165|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91588373|NCT02430051|183066166|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91588374|NCT02430051|183066167|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91588375|NCT02430051|183066168|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91588376|NCT02430051|183066169|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91588377|NCT02430051|183066170|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91588378|NCT02430051|183066171|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91588379|NCT02430051|183066172|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91588380|NCT02430051|183066173|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
91588381|NCT02430051|183066174|SUPERIORITY||||||<|0.0001|||||||Multivariate linear regression|Adjusted for autism severity, IQ, dental fear and anxiety, sensory over-responsivity, general anxiety, expressive communication, gender, and age.||||||<0.0001
91588382|NCT02430051|183066175|SUPERIORITY|||||||0.61|||||||General linear mixed model|||||||0.61
91588383|NCT01009554|183066205|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.126|STANDARD_ERROR_OF_MEAN|0.0905||0.168|TWO_SIDED|95.0|-0.054|0.306||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.306|-0.054|0.168
91588384|NCT01009554|183066207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.006|STANDARD_ERROR_OF_MEAN|0.067||0.928|TWO_SIDED|95.0|-0.127|0.139||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.139|-0.127|0.928
91588385|NCT01009554|183066208|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.235|STANDARD_ERROR_OF_MEAN|0.0718||0.002|TWO_SIDED|95.0|0.092|0.378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.378|0.092|0.002
91588386|NCT01009554|183066209|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.041|STANDARD_ERROR_OF_MEAN|0.1235||0.741|TWO_SIDED|95.0|-0.205|0.286||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.286|-0.205|0.741
91588387|NCT01009554|183066210|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.161|STANDARD_ERROR_OF_MEAN|0.1386||0.249|TWO_SIDED|95.0|-0.437|0.115||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.115|-0.437|0.249
91588388|NCT01009554|183066211|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.201|STANDARD_ERROR_OF_MEAN|0.1398||0.154|TWO_SIDED|95.0|-0.479|0.077||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.077|-0.479|0.154
91588389|NCT01009554|183066212|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.195|STANDARD_ERROR_OF_MEAN|0.0746||0.011|TWO_SIDED|95.0|-0.343|-0.047||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.047|-0.343|0.011
91588390|NCT01009554|183066213|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.334|STANDARD_ERROR_OF_MEAN|0.0703|<|0.001|TWO_SIDED|95.0|-0.474|-0.195||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.195|-0.474|<0.001
91588391|NCT01009554|183066214|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.0939||0.025|TWO_SIDED|95.0|-0.401|-0.027||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.027|-0.401|0.025
91588392|NCT01009554|183066215|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.0562||0.319|TWO_SIDED|95.0|-0.055|0.168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.168|-0.055|0.319
91588393|NCT01009554|183066216|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.272|STANDARD_ERROR_OF_MEAN|0.0668|<|0.001|TWO_SIDED|95.0|0.139|0.405||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.405|0.139|<0.001
91588394|NCT01009554|183066217|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.398|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|0.231|0.565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.565|0.231|<0.001
91588395|NCT01009554|183066218|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.0271||0.27|TWO_SIDED|95.0|-0.024|0.084||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.084|-0.024|0.270
91588396|NCT01009554|183066219|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.0324|<|0.001|TWO_SIDED|95.0|0.073|0.202||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.202|0.073|<0.001
91588397|NCT01009554|183066220|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0399|<|0.001|TWO_SIDED|95.0|0.114|0.273||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.273|0.114|<0.001
91588398|NCT01009554|183066221|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0273||0.217|TWO_SIDED|95.0|-0.02|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|-0.020|0.217
91588399|NCT01009554|183066222|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.073|0.2||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.200|0.073|<0.001
91588400|NCT01009554|183066223|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.195|STANDARD_ERROR_OF_MEAN|0.0406|<|0.001|TWO_SIDED|95.0|0.114|0.276||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.276|0.114|<0.001
91588401|NCT01009554|183066224|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0716||0.444|TWO_SIDED|95.0|-0.087|0.197||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.197|-0.087|0.444
91588402|NCT01009554|183066225|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.349|STANDARD_ERROR_OF_MEAN|0.0843|<|0.001|TWO_SIDED|95.0|0.182|0.517||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.517|0.182|<0.001
91588403|NCT01009554|183066226|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.542|STANDARD_ERROR_OF_MEAN|0.1063|<|0.001|TWO_SIDED|95.0|0.331|0.754||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.754|0.331|<0.001
91588404|NCT01009554|183066227|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.032|STANDARD_ERROR_OF_MEAN|0.0344||0.361|TWO_SIDED|95.0|-0.037|0.1||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.100|-0.037|0.361
91588405|NCT01009554|183066228|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.092|0.256||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.256|0.092|<0.001
91588406|NCT01009554|183066229|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.264|STANDARD_ERROR_OF_MEAN|0.0504|<|0.001|TWO_SIDED|95.0|0.164|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.164|<0.001
91588407|NCT01009554|183066230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0345||0.331|TWO_SIDED|95.0|-0.035|0.102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.102|-0.035|0.331
91588408|NCT01009554|183066231|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.177|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.095|0.259||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.259|0.095|<0.001
91588409|NCT01009554|183066232|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.265|STANDARD_ERROR_OF_MEAN|0.0519|<|0.001|TWO_SIDED|95.0|0.162|0.368||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.368|0.162|<0.001
91588410|NCT01009554|183066233|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.138|STANDARD_ERROR_OF_MEAN|0.0726||0.06|TWO_SIDED|95.0|-0.006|0.282||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.282|-0.006|0.060
91588411|NCT01009554|183066234|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.338|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.165|0.51||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.510|0.165|<0.001
91588412|NCT01009554|183066235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.394|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.176|0.612||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.612|0.176|<0.001
91588413|NCT01009554|183066236|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072|STANDARD_ERROR_OF_MEAN|0.0355||0.045|TWO_SIDED|95.0|0.002|0.143||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.143|0.002|0.045
91588414|NCT01009554|183066237|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.178|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|0.095|0.26||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.260|0.095|<0.001
91588415|NCT01009554|183066238|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|95.0|0.094|0.3||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.300|0.094|<0.001
91588416|NCT01009554|183066239|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.077|STANDARD_ERROR_OF_MEAN|0.0355||0.034|TWO_SIDED|95.0|0.006|0.147||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.147|0.006|0.034
91588417|NCT01009554|183066240|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0398|<|0.001|TWO_SIDED|95.0|0.089|0.247||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.247|0.089|<0.001
91588418|NCT01009554|183066241|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0516|<|0.001|TWO_SIDED|95.0|0.091|0.296||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.296|0.091|<0.001
91588419|NCT01009554|183066242|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.031||0.524|TWO_SIDED|95.0|-0.082|0.042||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.042|-0.082|0.524
91588420|NCT01009554|183066243|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0395||0.172|TWO_SIDED|95.0|-0.024|0.133||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.133|-0.024|0.172
91647931|NCT03118765|183188293|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.522 for GSP304 20 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
91588421|NCT01009554|183066244|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.116|STANDARD_ERROR_OF_MEAN|0.0439||0.01|TWO_SIDED|95.0|0.028|0.203||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.203|0.028|0.010
91588422|NCT01009554|183066245|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.014|STANDARD_ERROR_OF_MEAN|0.0145||0.348|TWO_SIDED|95.0|-0.043|0.015||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.015|-0.043|0.348
91588423|NCT01009554|183066246|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0186||0.185|TWO_SIDED|95.0|-0.012|0.062||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.062|-0.012|0.185
91588424|NCT01009554|183066247|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.049|STANDARD_ERROR_OF_MEAN|0.0196||0.014|TWO_SIDED|95.0|0.01|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|0.010|0.014
91588425|NCT01009554|183066248|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.016||0.623|TWO_SIDED|95.0|-0.04|0.024||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.024|-0.040|0.623
91588426|NCT01009554|183066249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0186||0.192|TWO_SIDED|95.0|-0.013|0.061||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.061|-0.013|0.192
91588427|NCT01009554|183066250|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.057|STANDARD_ERROR_OF_MEAN|0.0213||0.009|TWO_SIDED|95.0|0.014|0.099||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.099|0.014|0.009
91588428|NCT01009554|183066251|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0384||0.893|TWO_SIDED|95.0|-0.081|0.071||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.071|-0.081|0.893
91588429|NCT01009554|183066252|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0476||0.655|TWO_SIDED|95.0|-0.073|0.116||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.116|-0.073|0.655
91588430|NCT01009554|183066253|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.0693||0.002|TWO_SIDED|95.0|0.084|0.359||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.359|0.084|0.002
91588431|NCT01009554|183066254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.0187||0.914|TWO_SIDED|95.0|-0.039|0.035||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.035|-0.039|0.914
91588432|NCT01009554|183066255|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0229||0.646|TWO_SIDED|95.0|-0.035|0.056||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.056|-0.035|0.646
91588433|NCT01009554|183066256|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.0309||0.001|TWO_SIDED|95.0|0.04|0.163||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.163|0.040|0.001
91588434|NCT01009554|183066257|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0179||0.93|TWO_SIDED|95.0|-0.034|0.037||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.037|-0.034|0.930
91647932|NCT03118765|183188293|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.926 for GSP304 40 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
91588435|NCT01009554|183066258|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.0224||0.486|TWO_SIDED|95.0|-0.029|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.060|-0.029|0.486
91588436|NCT01009554|183066259|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0338||0.001|TWO_SIDED|95.0|0.045|0.18||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.180|0.045|0.001
91588437|NCT01009554|183066260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1006||0.237|TWO_SIDED|95.0|-0.08|0.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.320|-0.080|0.237
91588438|NCT01009554|183066261|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.298|0.743||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.743|0.298|<0.001
91588439|NCT01009554|183066262|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.567|STANDARD_ERROR_OF_MEAN|0.1367|<|0.001|TWO_SIDED|95.0|0.295|0.839||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.839|0.295|<0.001
91588440|NCT01009554|183066263|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0491||0.21|TWO_SIDED|95.0|-0.036|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.160|-0.036|0.210
91588441|NCT01009554|183066264|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|0.153|0.372||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.372|0.153|<0.001
91588442|NCT01009554|183066265|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.281|STANDARD_ERROR_OF_MEAN|0.0654|<|0.001|TWO_SIDED|95.0|0.151|0.411||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.411|0.151|<0.001
91647933|NCT03118765|183188294|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.944 for GSP304 10 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
91588443|NCT01009554|183066266|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.066|STANDARD_ERROR_OF_MEAN|0.0496||0.187|TWO_SIDED|95.0|-0.033|0.165||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.165|-0.033|0.187
91588444|NCT01009554|183066267|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.256|STANDARD_ERROR_OF_MEAN|0.0544|<|0.001|TWO_SIDED|95.0|0.148|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.148|<0.001
91647934|NCT03118765|183188294|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.808 for GSP304 20 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
91521261|NCT02954354|182917047|SUPERIORITY||Difference|-8.1||||0.0094||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.0094
91588445|NCT01009554|183066268|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.273|STANDARD_ERROR_OF_MEAN|0.0669|<|0.001|TWO_SIDED|95.0|0.14|0.406||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.406|0.140|<0.001
91588446|NCT04427501|183066296|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.15|0.58||||||||0.58|0.15|
91647935|NCT03118765|183188294|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 2.125 for GSP304 40 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
91647936|NCT03118765|183188295|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.004|TWO_SIDED|95.0|0.04|0.21|||Mixed Models Analysis|||||0.21|0.04|0.004
91647937|NCT03118765|183188295|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
91647938|NCT03118765|183188295|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.007|TWO_SIDED|95.0|0.03|0.21|||Mixed Models Analysis|||||0.21|0.03|0.007
91647939|NCT03118765|183188295|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
91588447|NCT04427501|183066296|SUPERIORITY||Odds Ratio (OR)|0.12|||||TWO_SIDED|95.0|0.04|0.31||||||||0.31|0.04|
91588448|NCT04427501|183066297|SUPERIORITY||Odds Ratio (OR)|0.23|||||TWO_SIDED|95.0|0.13|0.4||||||||0.40|0.13|
91588449|NCT04427501|183066298|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.221||0.6921|TWO_SIDED|95.0|-0.35|0.52|||Mixed Models Analysis|||||0.52|-0.35|0.6921
91588450|NCT04427501|183066298|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.219||0.211|TWO_SIDED|95.0|-0.71|0.16|||Mixed Models Analysis|||||0.16|-0.71|0.2110
91647940|NCT03118765|183188296|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.001|TWO_SIDED|95.0|0.08|0.28|||Mixed Models Analysis|||||0.28|0.08|0.001
91647941|NCT03118765|183188296|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.005|TWO_SIDED|95.0|0.05|0.25|||Mixed Models Analysis|||||0.25|0.05|0.005
91588451|NCT04427501|183066298|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.225||0.163|TWO_SIDED|95.0|-0.13|0.76|||Mixed Models Analysis|||||0.76|-0.13|0.1630
91588452|NCT04427501|183066298|SUPERIORITY||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.22||0.0099|TWO_SIDED|95.0|-1.0|-0.14|||Mixed Models Analysis|||||-0.14|-1.00|0.0099
91588453|NCT04427501|183066303|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.13|1.86||||||||1.86|1.13|
91588454|NCT04427501|183066303|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|1.24|1.95||||||||1.95|1.24|
91647942|NCT03118765|183188296|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.032|TWO_SIDED|95.0|0.01|0.21|||Mixed Models Analysis|||||0.21|0.01|0.032
91647943|NCT03118765|183188296|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.001|TWO_SIDED|95.0|0.07|0.27|||Mixed Models Analysis|||||0.27|0.07|0.001
91588455|NCT04427501|183066303|SUPERIORITY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.06|2.53||||||||2.53|1.06|
91588456|NCT04427501|183066304|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.17|1.93||||||||1.93|1.17|
91588457|NCT04427501|183066304|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.33|2.09||||||||2.09|1.33|
91588458|NCT04427501|183066304|SUPERIORITY||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.22|2.9||||||||2.9|1.22|
91588459|NCT04427501|183066305|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.18|0.64||||||||0.64|0.18|
91588460|NCT04427501|183066305|SUPERIORITY||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.07|0.38||||||||0.38|0.07|
91588461|NCT04427501|183066305|SUPERIORITY||Odds Ratio (OR)|0.25|||||TWO_SIDED|95.0|0.06|1.05||||||||1.05|0.06|
91588462|NCT04427501|183066306|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0|TWO_SIDED|95.0|-1.46|-0.94|||Mixed Models Analysis|||||-0.94|-1.46|<0.0000000
91588463|NCT04427501|183066306|SUPERIORITY||Mean Difference (Net)|-1.09|||<|0|TWO_SIDED|95.0|-1.34|-0.85|||Mixed Models Analysis|||||-0.85|-1.34|<0.0000000
91588464|NCT04427501|183066306|SUPERIORITY||Mean Difference (Net)|-0.99||||3.777e-05|TWO_SIDED|95.0|-1.45|-0.52|||Mixed Models Analysis|||||-0.52|-1.45|0.00003777
91588465|NCT04427501|183066307|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
91588466|NCT04427501|183066307|SUPERIORITY||Hazard Ratio (HR)|1.111||||0.13|TWO_SIDED||||||Stratified Log-rank|||||||0.130
91588467|NCT04427501|183066307|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.012|TWO_SIDED||||||Stratified Log-rank|||||||0.012
91588468|NCT04427501|183066308|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
91588469|NCT04427501|183066308|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.033|TWO_SIDED||||||Stratified Log-rank|||||||0.033
91588470|NCT04427501|183066308|SUPERIORITY||Hazard Ratio (HR)|1.521||||0.017|TWO_SIDED||||||Stratified Log-rank|||||||0.017
91647944|NCT03118765|183188297|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.166|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.166
91647945|NCT03118765|183188297|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.182|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.182
91647946|NCT03118765|183188297|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.401|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||||0.17|-0.07|0.401
91647947|NCT03118765|183188297|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.574|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||||0.16|-0.09|0.574
91647948|NCT03118765|183188298|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.493|TWO_SIDED|95.0|-0.1|0.21|||Mixed Models Analysis|||||0.21|-0.10|0.493
91647949|NCT03118765|183188298|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.864|TWO_SIDED|95.0|-0.17|0.14|||Mixed Models Analysis|||||0.14|-0.17|0.864
91647950|NCT03118765|183188298|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.978|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.978
91647951|NCT03118765|183188298|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.20|-0.10|0.500
91647952|NCT03118765|183188299|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.003|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis|||||0.20|0.04|0.003
91781616|NCT02592798|183442629|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.9402|6.5402|||||Abatacept - Placebo for Pain interference|||6.5402|-13.9402|
91588471|NCT04427501|183066309|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.243||0.499|TWO_SIDED|95.0|-0.31|0.64|||Mixed Models Analysis|||||0.64|-0.31|0.499
91588472|NCT04427501|183066309|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.241||0.492|TWO_SIDED|95.0|-0.64|0.31|||Mixed Models Analysis|||||0.31|-0.64|0.492
91647953|NCT03118765|183188299|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.001|TWO_SIDED|95.0|0.06|0.22|||Mixed Models Analysis|||||0.22|0.06|0.001
91781617|NCT02592798|183442629|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-6.5736|4.5736|||||Abatacept - Placebo for Physical function|||4.5736|-6.5736|
91781618|NCT02592798|183442630|SUPERIORITY||Mean Difference (Final Values)|12.45|||||TWO_SIDED|95.0|-4.595|29.485|||||Abatacept - Placebo for Fatigue|||29.4850|-4.5950|
91781619|NCT02592798|183442630|SUPERIORITY||Mean Difference (Final Values)|7.14|||||TWO_SIDED|95.0|-2.5917|16.8717|||||Abatacept - Placebo for Pain interference|||16.8717|-2.5917|
91781620|NCT02592798|183442630|SUPERIORITY||Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-12.1068|10.3468|||||Abatacept - Placebo for Mobility|||10.3468|-12.1068|
91781621|NCT01216189|183442639|SUPERIORITY||Mean change|-0.138||||0.004|TWO_SIDED|95.0|-0.232|-0.044||The threshold for statistical significance was p = 0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||-0.044|-0.232|0.004
91781622|NCT01216189|183442639|SUPERIORITY||Mean change|-0.011||||0.805|TWO_SIDED|95.0|-0.097|0.075||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||0.075|-0.097|0.805
91781623|NCT01216189|183442640|SUPERIORITY||Mean change in FSFI scores|-9.33||||0.013|TWO_SIDED|95.0|-16.66|-1.99||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for Age, Psychological General Well-being total score and relationship with partner.||"The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using no preoperative radiotherapy as the reference group."||-1.99|-16.66|0.013
91588473|NCT04427501|183066309|SUPERIORITY||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.246||0.125|TWO_SIDED|95.0|-0.11|0.86|||Mixed Models Analysis|||||0.86|-0.11|0.125
91588474|NCT04427501|183066309|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.236||0.069|TWO_SIDED|95.0|-0.89|0.03|||Mixed Models Analysis|||||0.03|-0.89|0.069
91588475|NCT04427501|183066310|SUPERIORITY||Odds Ratio (OR)|1.74||||0.034|TWO_SIDED|95.0|1.04|2.9|||Regression, Logistic|||||2.90|1.04|0.034
91588476|NCT04427501|183066310|SUPERIORITY||Odds Ratio (OR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91|||Regression, Logistic|||||1.91|0.69|0.594
91647954|NCT03118765|183188299|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|||||0.21|0.06|0.001
91647955|NCT03118765|183188299|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Mixed Models Analysis|||||0.23|0.08|<0.001
91647956|NCT03118765|183188300|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
91647957|NCT03118765|183188300|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.061|TWO_SIDED|95.0|0.0|0.18|||Mixed Models Analysis|||||0.18|-0.00|0.061
91647958|NCT03118765|183188300|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Mixed Models Analysis|||||0.16|-0.02|0.140
91647959|NCT03118765|183188300|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
91709077|NCT03035916|183311325|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91781624|NCT03751657|183442668|OTHER||Treatment difference|-0.18||||0.0818|TWO_SIDED|95.0|-0.38|0.02|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear mixed model for repeated measures (MMRM) with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate. Furthermore, the model includes the interaction between visit and all explanatory variables.||0.02|-0.38|0.0818
91781625|NCT03751657|183442682|OTHER||Treatment difference|-1.97||||0.0818|TWO_SIDED|95.0|-4.19|0.25|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear MMRM with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate.Furthermore, the model includes the interaction between visit and all explanatory variables.||0.25|-4.19|0.0818
91781626|NCT04603027|183442684|SUPERIORITY||Posterior Mean difference|-5.99|||||TWO_SIDED|95.0|-20.28|7.12||||||||7.12|-20.28|
91781627|NCT04603027|183442684|SUPERIORITY||Posterior Mean difference|-8.35|||||TWO_SIDED|95.0|-22.07|5.04||||||||5.04|-22.07|
91781628|NCT04603027|183442684|SUPERIORITY||Posterior Mean difference|-9.1|||||TWO_SIDED|95.0|-23.22|4.65||||||||4.65|-23.22|
91781629|NCT04603027|183442685|SUPERIORITY||Posterior Mean difference|-2.6|||||TWO_SIDED|95.0|-13.91|9.9||||||||9.90|-13.91|
91781630|NCT04603027|183442685|SUPERIORITY||Posterior Mean difference|-3.33|||||TWO_SIDED|95.0|-15.21|8.52||||||||8.52|-15.21|
91781631|NCT04603027|183442685|SUPERIORITY||Posterior Mean difference|0.11|||||TWO_SIDED|95.0|-12.33|11.53||||||||11.53|-12.33|
91781632|NCT04603027|183442686|SUPERIORITY||Posterior Mean difference|-0.69|||||TWO_SIDED|95.0|-1.88|0.46||||||||0.46|-1.88|
91781633|NCT04603027|183442686|SUPERIORITY||Posterior Mean difference|-0.73|||||TWO_SIDED|95.0|-1.82|0.45||||||||0.45|-1.82|
91781634|NCT04603027|183442686|SUPERIORITY||Posterior Mean difference|-0.81|||||TWO_SIDED|95.0|-2.05|0.33||||||||0.33|-2.05|
91781635|NCT04603027|183442687|SUPERIORITY||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.01|6.94||||||||6.94|1.01|
91781636|NCT04603027|183442687|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.17|7.37||||||||7.37|1.17|
91781637|NCT04603027|183442687|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.63|4.7||||||||4.70|0.63|
91781638|NCT04603027|183442688|SUPERIORITY|||||||0.1|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.100
91588477|NCT04427501|183066310|SUPERIORITY||Odds Ratio (OR)|1.32||||0.291|TWO_SIDED|95.0|0.79|2.2|||Regression, Logistic|||||2.20|0.79|0.291
91588478|NCT04427501|183066310|SUPERIORITY||Odds Ratio (OR)|1.45||||0.143|TWO_SIDED|95.0|0.88|2.4|||Regression, Logistic|||||2.40|0.88|0.143
91588479|NCT04427501|183066311|SUPERIORITY||Odds Ratio (OR)|1.89||||0.014|TWO_SIDED|95.0|1.14|3.15|||Regression, Logistic|||||3.15|1.14|0.014
91588480|NCT04427501|183066311|SUPERIORITY||Odds Ratio (OR)|1.06||||0.828|TWO_SIDED|95.0|0.64|1.74|||Regression, Logistic|||||1.74|0.64|0.828
91588481|NCT04427501|183066311|SUPERIORITY||Odds Ratio (OR)|1.82||||0.022|TWO_SIDED|95.0|1.09|3.02|||Regression, Logistic|||||3.02|1.09|0.022
91647960|NCT02643966|183188301|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Year/Screen 1.|simple proportions|1.3||||0.005|TWO_SIDED|95.0|0.3|2.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||2.1|0.3|0.005
91588482|NCT04427501|183066311|SUPERIORITY||Odds Ratio (OR)|1.48||||0.119|TWO_SIDED|95.0|0.9|2.43|||Regression, Logistic|||||2.43|0.90|0.119
91588483|NCT04427501|183066314|SUPERIORITY||Odds Ratio (OR)|0.23||||0.098|TWO_SIDED|95.0|0.04|1.31|||Regression, Logistic|||||1.31|0.04|0.098
91588484|NCT04427501|183066314|SUPERIORITY||Odds Ratio (OR)|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Regression, Logistic|||||1.51|0.09|0.165
91588485|NCT04427501|183066314|SUPERIORITY||Odds Ratio (OR)|0.39||||0.191|TWO_SIDED|95.0|0.1|1.6|||Regression, Logistic|||||1.60|0.10|0.191
91588486|NCT04427501|183066314|SUPERIORITY||Odds Ratio (OR)|0.21||||0.075|TWO_SIDED|95.0|0.04|1.18|||Regression, Logistic|||||1.18|0.04|0.075
91588487|NCT04427501|183066315|SUPERIORITY|||||||0.616|||||||Stratified Log-rank|||||||0.616
91588488|NCT04427501|183066315|SUPERIORITY|||||||0.281|||||||Stratified Log-rank|||||||0.281
91588489|NCT04427501|183066315|SUPERIORITY|||||||0.815|||||||Stratified Log-rank|||||||0.815
91588490|NCT04427501|183066315|SUPERIORITY|||||||0.334|||||||Stratified Log-rank|||||||0.334
91588491|NCT03170154|183066322|OTHER||1-sided 95% Upper CL|99.99|||||ONE_SIDED||||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 92.5 for the AAS at 12 months.|||||
91588492|NCT03170154|183066323|OTHER||1-sided 95% Upper CL|99.98|||||ONE_SIDED|95.0|||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 96.7 for the BAS at 12 months.|||||
91588493|NCT05629962|183066391|SUPERIORITY|||||||0.954|||||||Cochran-Mantel-Haenszel|||||||0.954
91588494|NCT03951220|183066399|SUPERIORITY|||||||0.7343|||||||ANOVA|||||||0.7343
91588495|NCT03951220|183066400|OTHER|Correlation|Spearman (r)|0.39||||0.0445|TWO_SIDED|95.0|0.0|0.68|||Spearman's rank correlation coeffcieitn|||||0.68|0.00|0.0445
91588496|NCT03951220|183066401|SUPERIORITY|||||||0.0079||||||Dunn's multiple comparisons test|Kruskal-Wallis|||For baseline P1NP||||0.0079
91588497|NCT03951220|183066401|SUPERIORITY|||||||0.0482||||||Dunn's multiple comparison test|ANOVA|||For baseline sclerostin||||0.0482
91588498|NCT03951220|183066412|OTHER|||||||0.015|||||||Fisher-Freeman-Halton exact test|||||||0.015
91588499|NCT03951220|183066415|OTHER|||||||0.007|||||||Mann-Whitney test|||||||0.007
91588500|NCT05090995|183066424|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91588501|NCT05090995|183066425|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91588502|NCT05090995|183066426|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91588503|NCT05090995|183066427|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91588504|NCT05090995|183066428|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For baseline consequences||||<.0001
91588505|NCT05090995|183066428|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For effects with time||||<.0001
91781639|NCT04603027|183442688|SUPERIORITY|||||||0.034|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.034
91781640|NCT04603027|183442688|SUPERIORITY|||||||0.094|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.094
91781641|NCT04603027|183442692|SUPERIORITY||Posterior Mean Odds Ratio|2.14|||||TWO_SIDED|95.0|0.45|10.96||||||||10.96|0.45|
91781642|NCT04603027|183442692|SUPERIORITY||Posterior Mean Odds Ratio|2.02|||||TWO_SIDED|95.0|0.42|8.78||||||||8.78|0.42|
91781643|NCT04603027|183442692|SUPERIORITY||Posterior Mean Odds Ratio|2.12|||||TWO_SIDED|95.0|0.46|9.51||||||||9.51|0.46|
91588506|NCT05090995|183066429|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91588507|NCT05090995|183066430|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Effect of baseline sleep scores||||<.0001
91588508|NCT05090995|183066430|OTHER|||||||0.04|||||||Mixed Models Analysis|||For effects with time||||0.04
91588509|NCT05090995|183066431|OTHER|||||||0.02|||||||Mixed Models Analysis|||For interaction between treatment group and time||||0.02
91588510|NCT05090995|183066431|OTHER|||||||0.02|||||||Mixed Models Analysis|||Main effects of sex||||0.02
91588511|NCT05090995|183066431|OTHER|||||||0.0007|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||0.0007
91588512|NCT05090995|183066431|OTHER|||||||0.02|||||||Mixed Models Analysis|||||||0.02
91588513|NCT05090995|183066432|OTHER|||||||0.0001|||||||Mixed Models Analysis|||Main effect of day of the week.||||0.0001
91588514|NCT05090995|183066433|OTHER|||||||0.04|||||||Mixed Models Analysis|||For interaction between treatment condition and time||||0.04
91781644|NCT04603027|183442693|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
91781645|NCT04603027|183442693|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
91781646|NCT04603027|183442693|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
91781647|NCT04603027|183442694|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
91588515|NCT05090995|183066433|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of sex||||<.0001
91588516|NCT05090995|183066433|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||<0.0001
91588517|NCT05090995|183066433|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91588518|NCT01005459|183066434|OTHER|unpaired t-test|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
91588519|NCT01005459|183066434|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
91588520|NCT00174265|183066444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.||||0.0148
91588521|NCT00174265|183066445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0||||Significant level adjusted for one interim analysis was set as 0.049 two-sided.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.||||0.8100
91647961|NCT02643966|183188301|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Years/Screens 2 \& 3.|simple proportions|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.5||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||1.5|0.4|<0.001
91647962|NCT02643966|183188302|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Year/Screen 1.|simple proportions|17.8||||0.005|TWO_SIDED|95.0|4.4|31.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||31.1|4.4|0.005
91588522|NCT03231943|183066502|OTHER||Power model|0.9476|||||TWO_SIDED|90.0|0.8982|0.9971|||||The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1|||0.9971|0.8982|
91588523|NCT03231943|183066503|OTHER||Power model|0.928|||||TWO_SIDED|90.0|0.8877|0.9683|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1|||0.9683|0.8877|
91588524|NCT03231943|183066504|OTHER||Power Model|0.9352|||||TWO_SIDED|90.0|0.897|0.9734|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1|||0.9734|0.8970|
91709078|NCT03035916|183311326|OTHER|||||||0.249|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.249
91588525|NCT03231943|183066505|OTHER||Power model|0.7968|||||TWO_SIDED|90.0|0.6424|0.9512|||||The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1|||0.9512|0.6424|
91588526|NCT03231943|183066506|OTHER||Power model|0.789|||||TWO_SIDED|90.0|0.6149|0.9631|||||The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2|||0.9631|0.6149|
91588527|NCT03231943|183066507|OTHER||Power model|0.7955|||||TWO_SIDED|90.0|0.6562|0.9349|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9349|0.6562|
91588528|NCT03231943|183066512|OTHER||Power model|0.737|||||TWO_SIDED|90.0|0.5649|0.9091|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9091|0.5649|
91588529|NCT03231943|183066513|OTHER||Power model|0.7397|||||TWO_SIDED|90.0|0.5576|0.9218|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2|||0.9218|0.5576|
91588530|NCT03471871|183066520|OTHER||Least squares (LS) mean difference|-0.36||||0.099|TWO_SIDED|95.0|-0.78|0.07||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.07|-0.78|0.099
91588531|NCT03471871|183066520|OTHER||LS mean difference|-0.29||||0.176|TWO_SIDED|95.0|-0.72|0.14||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.14|-0.72|0.176
91588532|NCT03471871|183066521|OTHER||LS mean difference|-0.06||||0.948|TWO_SIDED|95.0|-1.95|1.83||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.83|-1.95|0.948
91588533|NCT03471871|183066522|OTHER||LS mean difference|0.52||||0.639|TWO_SIDED|95.0|-1.72|2.76||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.76|-1.72|0.639
91588534|NCT03471871|183066522|OTHER||LS mean difference|-1.16||||0.297|TWO_SIDED|95.0|-3.4|1.08||P-Value was at the 0.05 level of significance.|mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.08|-3.40|0.297
91781648|NCT04603027|183442694|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
91781649|NCT04603027|183442694|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
91781650|NCT04603027|183442695|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
91781651|NCT04603027|183442695|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
91781652|NCT04603027|183442695|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
91781653|NCT04603027|183442696|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
91781654|NCT04603027|183442696|SUPERIORITY||Posterior Mean difference|-2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
91781655|NCT04603027|183442696|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
91781656|NCT04603027|183442697|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
91781657|NCT04603027|183442697|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
91781658|NCT04603027|183442697|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
91781659|NCT04603027|183442698|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-19.99|28.84||||||||28.84|-19.99|
91588535|NCT03471871|183066523|OTHER||LS mean difference|-0.03||||0.979|TWO_SIDED|95.0|-2.22|2.17||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.17|-2.22|0.979
91588536|NCT03471871|183066524|OTHER||LS mean difference|0.185||||0.095|TWO_SIDED|95.0|-0.034|0.405||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<90%||0.405|-0.034|0.095
91588537|NCT03471871|183066524|OTHER||LS mean difference|0.245||||0.03|TWO_SIDED|95.0|0.025|0.464||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||When SpO2 is \<90%||0.464|0.025|0.030
91588538|NCT03471871|183066524|OTHER||LS mean difference|0.004||||0.885|TWO_SIDED|95.0|-0.058|0.067||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.067|-0.058|0.885
91588539|NCT03471871|183066524|OTHER||LS mean difference|0.044||||0.158|TWO_SIDED|95.0|-0.018|0.107||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.107|-0.018|0.158
91781660|NCT04603027|183442698|SUPERIORITY||Posterior Mean difference|-2.49|||||TWO_SIDED|95.0|-26.47|21.55||||||||21.55|-26.47|
91588540|NCT03471871|183066524|OTHER||LS mean difference|0.001||||0.462|TWO_SIDED|95.0|-0.002|0.005||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.005|-0.002|0.462
91781661|NCT04603027|183442698|SUPERIORITY||Posterior Mean difference|13.36|||||TWO_SIDED|95.0|-12.03|36.92||||||||36.92|-12.03|
91781662|NCT04603027|183442699|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
91781663|NCT04603027|183442699|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
91781664|NCT04603027|183442699|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
91781665|NCT04603027|183442700|SUPERIORITY||Posterior Mean difference|13.71|||||TWO_SIDED|95.0|-50.62|73.35||||||||73.35|-50.62|
91781666|NCT04603027|183442700|SUPERIORITY||Posterior Mean difference|73.69|||||TWO_SIDED|95.0|21.69|126.92||||||||126.92|21.69|
91781667|NCT04603027|183442700|SUPERIORITY||Posterior Mean difference|8.41|||||TWO_SIDED|95.0|-44.58|56.81||||||||56.81|-44.58|
91781668|NCT04603027|183442701|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
91781669|NCT04603027|183442701|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
91781670|NCT04603027|183442701|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
91781671|NCT03894813|183442705|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
91781672|NCT03894813|183442706|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
91781673|NCT03894813|183442707|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
91781674|NCT03894813|183442708|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
91521262|NCT02954354|182917047|SUPERIORITY||Difference|-15.3||||0.0007||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.0007
91588541|NCT03471871|183066524|OTHER||LS mean difference|0.002||||0.166|TWO_SIDED|95.0|-0.001|0.006||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.006|-0.001|0.166
91588542|NCT03471871|183066526|OTHER||LS mean difference|0.07||||0.699|TWO_SIDED|95.0|-0.31|0.46||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: Mean SpO2 during TST||0.46|-0.31|0.699
91588543|NCT03471871|183066526|OTHER||LS mean difference|0.25||||0.169|TWO_SIDED|95.0|-0.11|0.61||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: Mean SpO2 during TST||0.61|-0.11|0.169
91588544|NCT03471871|183066527|OTHER||LS mean difference|0.312||||0.472|TWO_SIDED|95.0|-0.558|1.181||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<90%||1.181|-0.558|0.472
91709079|NCT03035916|183311326|OTHER|||||||0.091|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.091
91709080|NCT03035916|183311326|OTHER|||||||0.493|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.493
91588545|NCT03471871|183066527|OTHER||LS mean difference|0.067||||0.479|TWO_SIDED|95.0|-0.124|0.258||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<85%||0.258|-0.124|0.479
91588546|NCT03471871|183066527|OTHER||LS mean difference|0.002||||0.852|TWO_SIDED|95.0|-0.019|0.023||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<80%||0.023|-0.019|0.852
91588547|NCT03471871|183066527|OTHER||LS mean difference|0.088||||0.733|TWO_SIDED|95.0|-0.431|0.607||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<90%||0.607|-0.431|0.733
91588548|NCT03471871|183066527|OTHER||LSM difference|0.056||||0.518|TWO_SIDED|95.0|-0.117|0.228||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: When SpO2 is \<85%||0.228|-0.117|0.518
91588549|NCT03471871|183066527|OTHER||LS mean difference|0.006||||0.576|TWO_SIDED|95.0|-0.015|0.026||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<80%||0.026|-0.015|0.576
91588550|NCT03040622|183066529|OTHER|||||||0.06|||||||ANOVA|||||||0.06
91588551|NCT03040622|183066530|OTHER|||||||0.009|||||||ANOVA|||||||0.009
91588552|NCT03040622|183066531|OTHER|||||||0.001|||||||ANOVA|||||||0.001
91588553|NCT02673619|183066561|OTHER||Percentage difference|25.0|||||TWO_SIDED|90.0|-21.1|75.1||||||||75.1|-21.1|
91588554|NCT02673619|183066561|OTHER||Percentage difference|25.5|||||TWO_SIDED|90.0|-10.2|59.2||||||||59.2|-10.2|
91588555|NCT02673619|183066562|OTHER||Percentage Difference|-16.2|||||TWO_SIDED|90.0|-59.7|32.0||||||||32.0|-59.7|
91588556|NCT02673619|183066562|OTHER||Percentage Difference|18.0|||||TWO_SIDED|90.0|-18.8|52.1||||||||52.1|-18.8|
91588557|NCT02673619|183066566|OTHER||Percentage Difference|16.2|||||TWO_SIDED|90.0|-32.0|59.7||||||||59.7|-32.0|
91588558|NCT02673619|183066566|OTHER||Percentage Difference|7.5|||||TWO_SIDED|90.0|-27.7|42.3||||||||42.3|-27.7|
91588559|NCT03444324|183066585|NON_INFERIORITY|The primary efficacy analysis of this endpoint was to test non-inferiority in the Per-protocol Set. The final analysis was performed using a two-way analysis of variance (ANOVA). Non-inferiority was to be demonstrated if the upper confidence limit of the two-sided 95 % confidence interval (CI) for the difference in the least squares mean (LSM) was less than the non-inferiority margin (150 mL).|Difference in LSM|-279.43|||<|0.001|TWO_SIDED|95.0|-552.38|-6.48||p-value from Van Elteren test, stratified by predictive blood loss (\> 1,000 mL to = 2,000 mL and \>2,000 mL)|Van Elteren test|||||-6.48|-552.38|<0.001
91588560|NCT03444324|183066586|OTHER||Difference in response rate|38.1|||<|0.001|TWO_SIDED|95.0|26.0|50.3|||Cochran-Mantel-Haenszel|P-value is from a Cochran-Mantel-Haenszel model stratified by predictive blood loss (\> 1,000 mL to ≤ 2,000 mL and \> 2,000 mL).||||50.3|26|<0.001
91588561|NCT03444324|183066587|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91588562|NCT03444324|183066593|OTHER||Difference in LSM|-15.5|||<|0.831|TWO_SIDED|95.0|-157.83|126.88|||ANOVA|||||126.88|-157.83|<0.831
91588563|NCT03444324|183066594|OTHER||Difference in LSM|12.4|||=|0.809|TWO_SIDED|95.0|-88.84|113.66|||ANOVA|||||113.66|-88.84|=0.809
91588564|NCT03444324|183066595|OTHER||Difference in proportion|-4.8|||=|0.022|TWO_SIDED|95.0|-8.9|-0.7|||Cochran-Mantel-Haenszel|||||-0.7|-8.9|=0.022
91588565|NCT01078220|183066615|SUPERIORITY_OR_OTHER||Relative Risk|6.0|||||TWO_SIDED|95.0|3.91|9.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||9.21|3.91|
91588566|NCT01078220|183066615|SUPERIORITY_OR_OTHER||Relative Risk|2.88|||||TWO_SIDED|95.0|1.18|7.08|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||7.08|1.18|
91588567|NCT01078220|183066619|SUPERIORITY_OR_OTHER||Relative Risk|1.64|||||TWO_SIDED|95.0|1.17|2.3|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||2.3|1.17|
91588568|NCT01078220|183066619|SUPERIORITY_OR_OTHER||Relative Risk|1.05|||||TWO_SIDED|95.0|0.82|1.35|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.35|0.82|
91588569|NCT01078220|183066619|SUPERIORITY_OR_OTHER||Relative Risk|1.02|||||TWO_SIDED|95.0|0.53|1.98|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||1.98|0.53|
91588570|NCT01078220|183066619|SUPERIORITY_OR_OTHER||Relative Risk|0.78|||||TWO_SIDED|95.0|0.5|1.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.21|0.5|
91588571|NCT03824639|183066620|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.37|||||TWO_SIDED|||||||||||||
91588572|NCT03824639|183066621|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.18|||||TWO_SIDED|||||||||||||
91588573|NCT02616614|183066668|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80,1.25\] for the PP population.|Mean Difference (Net)|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
91588574|NCT02616614|183066668|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
91588575|NCT02616614|183066668|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91588576|NCT02616614|183066669|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80, 1.25\] for the PP population.|Mean Difference (Net)|1.0|||||TWO_SIDED|90.0|0.9|1.11||||||||1.11|0.90|
91588577|NCT02616614|183066669|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
91647963|NCT02643966|183188302|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Years/Screens 2 and 3.|simple proportions|13.5|||<|0.001|TWO_SIDED|95.0|4.9|22.3||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||22.3|4.9|< 0.001
91647964|NCT02643966|183188304|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Year/Screen 1.|Slope|4.5|||<|0.001|TWO_SIDED|95.0|3.8|5.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||5.1|3.8|< 0.001
91588578|NCT02616614|183066669|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
91588579|NCT02616614|183066670|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Mean Difference (Net)|-0.022|||||TWO_SIDED|90.0|-0.087|0.043|||||Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).||0.043|-0.087|
91588580|NCT02748018|183066671|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.4||||||||-0.4||
91588581|NCT02748018|183066672|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.9|||||ONE_SIDED|97.5||-3.6||||||||-3.6||
91709081|NCT03035916|183311326|OTHER|||||||0.067|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.067
91588582|NCT02748018|183066673|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
91521263|NCT02954354|182917048|SUPERIORITY||Difference|6.8||||0.6623||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.6623
91588583|NCT02748018|183066674|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.8|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
91521264|NCT02954354|182917048|SUPERIORITY||Difference|1.8||||0.8184||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.8184
91521265|NCT02954354|182917048|SUPERIORITY||Difference|1.3||||0.9989||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.9989
91521266|NCT02954354|182917048|SUPERIORITY||Difference|1.7||||0.3706||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal congestion||||0.3706
91521267|NCT02954354|182917048|SUPERIORITY||Difference|-0.1||||0.9973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Feverishness or chills||||0.9973
91521268|NCT02954354|182917048|SUPERIORITY||Difference|-0.7||||0.676||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.6760
91521269|NCT02954354|182917048|SUPERIORITY||Difference|2.2||||0.4241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.4241
91521270|NCT02954354|182917049|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-39.5||||0.0563|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0563
91521271|NCT02954354|182917050|SUPERIORITY||Difference|-0.6||||0.7176||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.7176
91521272|NCT02954354|182917051|SUPERIORITY|||||||0.6728||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.6728
91521273|NCT02954354|182917052|SUPERIORITY|||||||0.2217||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2217
91521274|NCT03039023|182917059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.2||||||A p-value \<0.05 was considered significant.|Wilcoxon signed-rank test|||||||0.20
91521275|NCT03039023|182917059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521276|NCT03039023|182917059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521277|NCT03039023|182917059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91588584|NCT02748018|183066675|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.3||||||||0.3||
91588585|NCT02748018|183066676|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-1.0|||||ONE_SIDED|97.5||-0.2||||||||-0.2||
91588586|NCT02748018|183066677|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-2.2|||||ONE_SIDED|97.5||-0.9||||||||-0.9||
91588587|NCT02748018|183066678|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
91588588|NCT02748018|183066679|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) During Night|Mean Difference (Final Values)|-5.4|||||ONE_SIDED|97.5||-3.7||||||||-3.7||
91588589|NCT02748018|183066680|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) During Night|Mean Difference (Final Values)|18.8|||||ONE_SIDED|97.5|14.5||||||||||14.5|
91588590|NCT02748018|183066681|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|12.0|||||ONE_SIDED|97.5|8.8||||||||||8.8|
91588591|NCT02748018|183066682|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-2.6||||||||-2.6||
91588592|NCT02748018|183066683|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.6|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
91588593|NCT02748018|183066684|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-1.9||||||||-1.9||
91588594|NCT02748018|183066685|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.1|||||ONE_SIDED|97.5||0.3||||||||0.3||
91588595|NCT02748018|183066686|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-7.3|||||ONE_SIDED|97.5||-4.7||||||||-4.7||
91588596|NCT02748018|183066687|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|15.9|||||ONE_SIDED|97.5|11.1||||||||||11.1|
91588597|NCT02748018|183066688|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|13.6|||||ONE_SIDED|97.5|9.9||||||||||9.9|
91588598|NCT02748018|183066689|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.3|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
91588599|NCT02748018|183066690|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.2|||||ONE_SIDED|97.5||0.0||||||||0.0||
91588600|NCT02748018|183066691|NON_INFERIORITY|Non-inferiority margin: 2%. Treatment Effect on Time in Hypoglycemic Range (%) with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||0.7||||||||0.7||
91588601|NCT02748018|183066692|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
91588602|NCT02748018|183066693|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||0.2||||||||0.2||
91588603|NCT02748018|183066694|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|12.2|||||ONE_SIDED|97.5|8.3||||||||||8.3|
91588604|NCT02748018|183066695|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|6.3|||||ONE_SIDED|97.5|3.3||||||||||3.3|
91588605|NCT02748018|183066696|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
91588606|NCT02748018|183066697|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
91588607|NCT03801902|183066715|OTHER||||||||||||||||||"If 0-1 of initial 6 evaluable patients on an arm have a safety event, then the regimen will be deemed safe and that arm will continue to the second part of the study to enroll 6 additional evaluable patients. However, if 2 or more of the 6 patients develop a safety event, then that arm is considered not safe and will not continue to second part. The probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% is at least 77%. If the true toxicity rate is ≤ 18%, then the probability that the treatment will be deemed to be safe is at least 70%.~If fewer than 4 of the total of 12 evaluable patients on an arm experience a safety event, then the treatment will be considered tolerable. With a cohort of 12 patients, the probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% at least 78%. If the true toxicity rate is ≤ 18%, the probability that the treatment will be deemed to be safe is 85%."|||
91588608|NCT03952585|183066721|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|7.42|||||ONE_SIDED|90.0||19.46|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||19.46||
91588609|NCT03952585|183066721|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|5.55|||||ONE_SIDED|90.0||14.85|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||14.85||
91588610|NCT03952585|183066724|SUPERIORITY||Hazard Ratio (HR)|20.56|||||TWO_SIDED|95.0|1.05|403.31|||||Cause-specific; reference level = Arm 1|||403.31|1.05|
91588611|NCT03952585|183066724|SUPERIORITY||Hazard Ratio (HR)|12.87|||||TWO_SIDED|95.0|0.58|287.93|||||Reference level = Arm 1|||287.93|0.58|
91588612|NCT03952585|183066725|SUPERIORITY||Cox Proportional Hazard|1.78|||||TWO_SIDED|95.0|0.34|9.46|||||Cause-specific; reference level = Arm 1|||9.46|0.34|
91588613|NCT03952585|183066725|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.24|8.45|||||Cause-specific; reference level = Arm 1|||8.45|0.24|
91588614|NCT03952585|183066726|SUPERIORITY||Hazard Ratio (HR)|5.58|||||TWO_SIDED|95.0|0.67|46.41|||||Reference level = Arm 1|||46.41|0.67|
91588615|NCT03952585|183066726|SUPERIORITY||Hazard Ratio (HR)|4.87|||||TWO_SIDED|95.0|0.57|41.74|||||Reference level = Arm 1|||41.74|0.57|
91588616|NCT02260882|183066756|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
91588617|NCT02260882|183066756|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
91588618|NCT02260882|183066756|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
91588619|NCT02119325|183066766|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-4.64||||0.0487|TWO_SIDED|95.0|-9.26|-0.03||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect."||-0.03|-9.26|0.0487
91588620|NCT02119325|183066767|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-6.79||||0.6116|TWO_SIDED|95.0|-34.02|20.44||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect."||20.44|-34.02|0.6116
91588621|NCT01372410|183066892|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Day 8 analysis.|Wald Test|||||||<0.0001
91781675|NCT03894813|183442709|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
91588622|NCT01372410|183066892|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Pooled Day 7 and 8 analysis.|Wald Test|||||||<0.0001
91588623|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|||<|0.001|TWO_SIDED|95.0|0.058|0.168|||Mixed Models Analysis|||||0.168|0.058|<0.001
91588624|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.158|||Mixed Models Analysis|||||0.158|0.045|<0.001
91588625|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.068|0.179|||Mixed Models Analysis|||||0.179|0.068|<0.001
91588626|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.127|0.239|||Mixed Models Analysis|||||0.239|0.127|<0.001
91588627|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.069|0.182|||Mixed Models Analysis|||||0.182|0.069|<0.001
91588628|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|||<|0.001|TWO_SIDED|95.0|0.083|0.196|||Mixed Models Analysis|||||0.196|0.083|<0.001
91588629|NCT01372410|183066893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.157|||Mixed Models Analysis|||||0.157|0.045|<0.001
91588630|NCT00852592|183066955|SUPERIORITY_OR_OTHER||||||=|0.005|||||||ANOVA|||||||=0.005
91588631|NCT00852592|183066956|SUPERIORITY_OR_OTHER||||||=|0.004|||||||ANOVA|||||||=0.004
91588632|NCT00448435|183066982|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin + or - 15 L/min|Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|5.91||0.6383||95.0|-9.1|14.69||Confidence Interval|Mixed Models Analysis|||Difference between treatments \[(SLM + FP)- SFC\](SE) 2.8 (5.91)||14.69|-9.10|0.6383
91588633|NCT00412971|183067001|SUPERIORITY_OR_OTHER||difference in recurrence rate|0.25||||0.05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.05
91588634|NCT01387230|183067004|SUPERIORITY_OR_OTHER||Least squares mean difference|0.127|||<|0.001|TWO_SIDED|95.0|0.052|0.202|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.202|0.052|<0.001
91588635|NCT01387230|183067004|SUPERIORITY_OR_OTHER||Least squares mean difference|0.152|||<|0.001|TWO_SIDED|95.0|0.076|0.229|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.229|0.076|<0.001
91588636|NCT00372385|183067007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.758||||0.0026|TWO_SIDED|95.0|1.424|5.34|||Regression, Logistic|||||5.340|1.424|0.0026
91588637|NCT00372385|183067007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.709||||0.959|TWO_SIDED|95.0|0.91|3.212|||Regression, Logistic|||||3.212|0.910|0.959
91588638|NCT00372385|183067007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.589||||0.1089|TWO_SIDED|95.0|0.309|1.125|||Regression, Logistic|||||1.125|0.309|0.1089
91588639|NCT00372385|183067008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.632||||0.0041|TWO_SIDED|95.0|1.359|5.097|||Regression, Logistic|||||5.097|1.359|0.0041
91588640|NCT00372385|183067008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.623||||0.1324|TWO_SIDED|95.0|0.864|3.05|||Regression, Logistic|||||3.050|0.864|0.1324
91588641|NCT00372385|183067008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.591||||0.1099|TWO_SIDED|95.0|0.311|1.126|||Regression, Logistic|||||1.126|0.311|0.1099
91781676|NCT02948634|183442756|SUPERIORITY|||||||0.43|||||||ANOVA|||||||0.43
91588642|NCT01405937|183067013|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
91588643|NCT01405937|183067013|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
91588644|NCT02554903|183067021|SUPERIORITY||Geometric Mean Ratio|0.7393||||0.0158|TWO_SIDED|95.0|0.5798|0.9426|||ANCOVA|||||0.9426|0.5798|0.0158
91588645|NCT02340091|183067050|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9194|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
91588646|NCT01163721|183067055|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.93|-0.13||P-value is from an Analysis of Covariance (ANCOVA) model with treatment as factor and baseline HbA1c value as covariate. Due to the exploratory nature of this study, there were no adjustments for multiplicity.|ANCOVA|||Assuming a common standard deviation of 1.1%, 60 evaluable participants would provide 93% power to detect a statistically significant -1.0% difference in change from baseline HbA1c at Week 12 between ranolazine and placebo (2-sided alpha = 0.05). 80 participants were randomized to ensure at least 60 evaluable participants.||-0.13|-0.93|0.010
91588647|NCT01163721|183067056|SUPERIORITY_OR_OTHER||difference in LSM|-15.4|STANDARD_ERROR_OF_MEAN|12.83||0.234|TWO_SIDED|95.0|-41.0|10.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||10.2|-41.0|0.234
91709082|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
91588648|NCT01163721|183067057|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-2.5|STANDARD_ERROR_OF_MEAN|9.38||0.794|TWO_SIDED|95.0|-21.1|16.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||16.2|-21.1|0.794
91588649|NCT02708095|183067076|SUPERIORITY||Odds Ratio (OR)|1.28||||0.392|TWO_SIDED|95.0|0.73|2.27|||Regression, Logistic|||||2.27|0.73|0.392
91588650|NCT02708095|183067076|SUPERIORITY||Odds Ratio (OR)|1.84||||0.041|TWO_SIDED|95.0|1.02|3.29|||Regression, Logistic|||||3.29|1.02|0.041
91588651|NCT02708095|183067077|SUPERIORITY||Odds Ratio, log|1.25||||0.44|TWO_SIDED|95.0|0.71|2.19|||Regression, Logistic|||||2.19|0.71|0.440
91588652|NCT02708095|183067077|SUPERIORITY||Odds Ratio (OR)|2.04||||0.015|TWO_SIDED|95.0|1.15|3.62|||Regression, Logistic|||||3.62|1.15|0.015
91588653|NCT02708095|183067078|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.26||||0.6|TWO_SIDED|95.0|-1.23|0.71|||Mixed Models Analysis|||||0.71|-1.23|0.600
91588654|NCT02708095|183067078|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.58||||0.243|TWO_SIDED|95.0|-1.55|0.39|||Mixed Models Analysis|||||0.39|-1.55|0.243
91588655|NCT02708095|183067079|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.16||||0.285|TWO_SIDED|95.0|-0.45|0.13|||Mixed Models Analysis|||||0.13|-0.45|0.285
91588656|NCT02708095|183067079|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.33||||0.026|TWO_SIDED|95.0|-0.62|-0.04|||Mixed Models Analysis|||||-0.04|-0.62|0.026
91588657|NCT05640648|183067082|OTHER||Incidence rate ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.62|2.09|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||2.09|1.62|<0.001
91588658|NCT05640648|183067083|OTHER||Incidence Rate Ratio|7.46||||0.002|TWO_SIDED|95.0|2.06|26.95|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||26.95|2.06|0.002
91588659|NCT05640648|183067084|OTHER||Incidence Rate Ratio|1.25||||0.5|TWO_SIDED|95.0|0.65|2.42|||Mixed Models Analysis|Mixed effects poisson model adjusting for time and group (paired healthcentres, based on randomization)||||2.42|0.65|0.50
91588660|NCT05640648|183067087|OTHER||Incidence Rate Ratio|4.75|||<|0.001|TWO_SIDED|95.0|2.07|10.91|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||10.91|2.07|<0.001
91588661|NCT03254485|183067089|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.3681|TWO_SIDED|95.0|-0.95|0.35|||ANCOVA|||||0.35|-0.95|=0.3681
91588662|NCT03254485|183067090|SUPERIORITY||Least Squares Mean Difference|-16.74|||=|0.2817|TWO_SIDED|95.0|-47.38|13.9|||ANCOVA|||||13.90|-47.38|=0.2817
91588663|NCT03254485|183067091|SUPERIORITY||Least Squares Mean Difference|-0.297|||=|0.6508|TWO_SIDED|95.0|-1.591|0.997|||ANCOVA|||||0.997|-1.591|=0.6508
91588664|NCT03153111|183067093|SUPERIORITY||Geometric mean ratio|1.02||||0.7923|TWO_SIDED|90.0|0.88|1.19|||ANCOVA|||||1.19|0.88|0.7923
91781677|NCT02948634|183442757|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
91588665|NCT03153111|183067094|SUPERIORITY||Least square mean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.82||0.2172|TWO_SIDED|90.0|-8.17|1.17|||ANCOVA|||||1.17|-8.17|0.2172
91588666|NCT03153111|183067095|SUPERIORITY||Least square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3665|TWO_SIDED|90.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.3665
91781678|NCT02948634|183442758|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91588667|NCT02684357|183067097|OTHER||Adjusted percentage difference|72.5|||<|0.001|TWO_SIDED|95.0|66.8|78.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||78.2|66.8|< 0.001
91613920|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.086||||0.0001|TWO_SIDED|95.0|1.434|3.034|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.034|1.434|0.0001
91588668|NCT02684357|183067098|OTHER||Adjusted percentage difference|78.5|||<|0.001|TWO_SIDED|95.0|72.4|84.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.5|72.4|< 0.001
91588669|NCT02684357|183067099|OTHER||Adjusted percentage difference|47.5|||<|0.001|TWO_SIDED|95.0|40.9|54.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.2|40.9|< 0.001
91588670|NCT02684357|183067100|OTHER||Adjusted percentage difference|48.2|||<|0.001|TWO_SIDED|95.0|41.9|54.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.6|41.9|< 0.001
91588671|NCT02684357|183067101|OTHER||Adjusted percentage difference|62.2|||<|0.001|TWO_SIDED|95.0|55.5|68.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||68.9|55.5|< 0.001
91588672|NCT02684357|183067102|OTHER||Adjusted percentage difference|31.2|||<|0.001|TWO_SIDED|95.0|25.7|36.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.6|25.7|< 0.001
91588673|NCT02684357|183067103|OTHER||Adjusted percentage difference|27.6|||<|0.001|TWO_SIDED|95.0|16.7|38.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||38.5|16.7|< 0.001
91588674|NCT02684357|183067104|OTHER||Adjusted percentage difference|22.3|||<|0.001|TWO_SIDED|95.0|12.0|32.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.5|12.0|< 0.001
91588675|NCT02684357|183067105|OTHER||Adjusted percentage difference|27.0|||<|0.001|TWO_SIDED|95.0|17.0|37.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||37.0|17.0|< 0.001
91588676|NCT02684357|183067106|OTHER||Adjusted percentage difference|26.3|||<|0.001|TWO_SIDED|95.0|16.1|36.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.4|16.1|< 0.001
91588677|NCT02684357|183067107|OTHER||Adjusted percentage difference|30.2|||<|0.001|TWO_SIDED|95.0|19.6|40.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.9|19.6|< 0.001
91588678|NCT02684357|183067108|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
91588679|NCT02684357|183067109|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
91647965|NCT02643966|183188304|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Years/Screens 2 \& 3.|simple proportions|3.7|||<|0.001|TWO_SIDED|95.0|3.3|4.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||4.1|3.3|< 0.001
91588680|NCT02684357|183067110|OTHER||Adjusted percentage difference|19.2|||<|0.001|TWO_SIDED|95.0|9.5|28.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.8|9.5|< 0.001
91588681|NCT02684357|183067111|OTHER||Adjusted percentage difference|18.0|||<|0.001|TWO_SIDED|95.0|7.8|28.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.3|7.8|< 0.001
91588682|NCT02684357|183067112|OTHER||Adjusted percentage difference|20.2|||<|0.001|TWO_SIDED|95.0|9.1|31.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.4|9.1|< 0.001
91647966|NCT01493531|183188305|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.23|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.23|<0.0001
91588683|NCT02684357|183067113|OTHER||Mean Difference (Final Values)|-6.375|||<|0.001|TWO_SIDED|95.0|-7.102|-5.648|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.648|-7.102|< 0.001
91588684|NCT02684357|183067114|OTHER||Adjusted percentage difference|84.7|||<|0.001|TWO_SIDED|95.0|79.0|90.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||90.4|79.0|< 0.001
91588685|NCT02684357|183067115|OTHER||Adjusted percentage difference|29.1|||<|0.001|TWO_SIDED|95.0|18.5|39.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||39.6|18.5|< 0.001
91588686|NCT02684357|183067116|OTHER||Adjusted percentage difference|14.7||||0.001|TWO_SIDED|95.0|5.9|23.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||23.5|5.9|0.001
91588687|NCT03226275|183067205|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.46|||||TWO_SIDED|90.0|93.25|106.09||||||Statistical Comparison of Bisoprolol in Fasting state||106.09|93.25|
91647967|NCT01493531|183188305|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.34|0.52|||Cochran-Mantel-Haenszel|||||0.52|0.34|<0.0001
91647968|NCT01493531|183188306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.5716|TWO_SIDED|95.0|0.57|1.37|||Negative Binomial Regression|||||1.37|0.57|0.5716
91647969|NCT01493531|183188306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.7454|TWO_SIDED|95.0|0.6|1.45|||Negative Binomial Regression|||||1.45|0.60|0.7454
91647970|NCT01493531|183188307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.8466|TWO_SIDED|95.0|-0.24|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.24|0.8466
91647971|NCT01493531|183188307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.06||||0.6301|TWO_SIDED|95.0|-0.29|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.29|0.6301
91647972|NCT03070431|183188327|SUPERIORITY|It was assumed that radiotherapy with 5x4 Gy results in 6-month LPFS of 67% and an increase by 20% is clinically relevant when using 5x5 Gy. For comparison of 5x5 Gy and a historical control (5x4 Gy), it was assumed that it can be performed with a simple Pearson-Chi-Square test (2-sided significance level of 5%, power of 79%) if 40 patients treated with 5x5 Gy and 400 patients of the control group qualified for Propensity-Score adjusted comparison, assuming 6-month LPFS rates of 87% and 67%.|Risk Difference (RD)|20.0|||<|0.05|TWO_SIDED||||||Cochran-Mantel-Haenszel|||historical control group treated with 5 x 4 Gy|"In a prospective study, 6-month LPFS rates were 86% after longer-course (mainly 3Gyx10) and 67% after short-course radiotherapy (mainly 4Gyx5) \[Rades D, et al., Int J Radiat Oncol Biol Phys 2009;73:228-34.\]. For sample size calculations, it was assumed that conventional radiotherapy with 4Gyx5 results in 6-month LPFS of 67% and that an increase by 20% is clinically relevant and realistic with 5Gyx5. A sample size of 40 eligible patients was required for the phase 2 trial assuming that that 6-month LPFS would be 87% and estimated with a precision of +/-20% expressed as the half length of the associated two-sided confidence interval (95%), and power of \>=80%.~For comparison of phase 2 cohort and historical control group, it was assumed that this could be performed with a simple Pearson-Chi-Square test using a two-sided significance level of 5% (10%) and a power of 79% (86%) if 40 patients received 5Gyx5 and N=400 of the control group qualified for Propensity-Score adjusted comparison."|||<0.05
91588688|NCT03226275|183067205|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|96.76|||||TWO_SIDED|90.0|92.95|100.73||||||Statistical Comparison of Amlodipine in Fasting State||100.73|92.95|
91588689|NCT03226275|183067205|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.95|||||TWO_SIDED|90.0|90.02|108.76||||||Statistical Comparison of Bisoprolol in Fed State||108.76|90.02|
91647973|NCT00370396|183188337|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix-Synflorix minus Prevenar-Prevenar\] in terms of percentages of subjects reporting rectal fever \>39.0°C was computed.|Difference in percentage|-4.43|||||TWO_SIDED|95.0|-11.85|-0.21||||||Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever \> 39.0°C.||-0.21|-11.85|
91588690|NCT03226275|183067205|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|103.07|||||TWO_SIDED|90.0|95.53|111.2||||||Statistical Comparison of Amlodipine in Fed State||111.20|95.53|
91647974|NCT02340078|183188372|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9516|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
91588691|NCT03226275|183067206|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|97.85|||||TWO_SIDED|90.0|92.29|103.74||||||Statistical Comparison of Bisoprolol in Fasting State||103.74|92.29|
91588692|NCT03226275|183067206|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|100.03|||||TWO_SIDED|90.0|94.37|106.03||||||Statistical Comparison of Amlodipine in Fasting State||106.03|94.37|
91588693|NCT03226275|183067206|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|93.87|||||TWO_SIDED|90.0|84.56|104.2||||||Statistical Comparison of Bisoprolol in Fed State||104.20|84.56|
91588694|NCT03226275|183067206|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|106.56|||||TWO_SIDED|90.0|97.82|116.08||||||Statistical Comparison of Amlodipine in Fed State||116.08|97.82|
91588695|NCT03226275|183067207|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.13|||||TWO_SIDED|90.0|0.0|0.5||||||Statistical Comparison of Bisoprolol in Fasting State||0.50|0.00|
91588696|NCT03226275|183067207|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.0||||||Statistical Comparison of Amlodipine in Fasting State||0.00|-1.00|
91588697|NCT03226275|183067207|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Bisoprolol in Fed State||0.50|-1.00|
91781679|NCT01255436|183442797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.06|TWO_SIDED|95.0|-9.4|1.0||p-value\<0.05 is considered significant|t-test, 1 sided|||||1.0|-9.4|0.06
91781680|NCT01255436|183442798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-4.1|1.3||p-value \< 0.05 considered significant|t-test, 1 sided|||||1.3|-4.1|0.14
91588698|NCT03226275|183067207|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Amlodipine in Fed State||0.50|-1.00|
91588699|NCT03226275|183067209|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.98|||||TWO_SIDED|90.0|93.61|106.79||||||Statistical Comparison of Bisoprolol in Fasting State||106.79|93.61|
91588700|NCT03226275|183067209|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.68|||||TWO_SIDED|90.0|93.38|104.28||||||Statistical Comparison of Amlodipine in Fasting State||104.28|93.38|
91588701|NCT03226275|183067209|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.52|||||TWO_SIDED|90.0|89.75|108.15||||||Statistical Comparison of Bisoprolol in Fed State||108.15|89.75|
91588702|NCT03226275|183067209|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|104.06|||||TWO_SIDED|90.0|96.11|112.66||||||Statistical Comparison of Amlodipine in Fed State||112.66|96.11|
91781681|NCT01255436|183442799|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.045|TWO_SIDED|95.0|1.0|1.6|||Fisher Exact||Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)|||1.6|1.0|0.045
91781682|NCT01255436|183442800|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.014|TWO_SIDED|95.0|1.04|1.53|||Fisher Exact|||||1.53|1.04|0.014
91781683|NCT04816669|183442801|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.|Geometric mean ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 lyophilized SDV - BNT162b2 frozen-liquid MDV and the corresponding CI (based on the Student t distribution).|||0.77|0.60|
91588703|NCT01436071|183067219|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12||||0.012|TWO_SIDED|95.0|0.026|0.213|||ANCOVA|||||0.213|0.026|0.012
91588704|NCT01920594|183067244|SUPERIORITY||Mean Difference (Final Values)|2228.14||||0.082|TWO_SIDED|95.0|-292.84|4749.11|||ANCOVA||The point estimate was calculated as least square (LS) mean difference (final values) of S-100B Protein \[test\] and S-100B Protein \[reference\].|||4749.11|-292.84|0.0820
91588705|NCT01920594|183067245|SUPERIORITY||Mean Difference (Final Values)|777.95||||0.1997|TWO_SIDED|95.0|-424.04|1979.94|||ANCOVA||The point estimate was calculated as LS mean difference (final values) of GFAP \[test\] and GFAP \[reference\].|||1979.94|-424.04|0.1997
91588706|NCT01920594|183067251|SUPERIORITY||Estimate of comparison (Ratio)|1.77||||0.153|TWO_SIDED|95.0|0.8|3.9|||ANOVA||The point estimate was calculated as Geometric mean ratio of S-100B\[test\] and S-100B\[reference\].|||3.90|0.80|0.1530
91588707|NCT01920594|183067252|SUPERIORITY||Estimate of comparison (Ratio)|3.13||||0.1377|TWO_SIDED|95.0|0.69|14.26|||ANOVA||The point estimate was calculated as Geometric mean ratio of GFAP\[test\] and GFAP\[reference\].|||14.26|0.69|0.1377
91588708|NCT01920594|183067253|SUPERIORITY||Mean Difference (Final Values)|34.56|||<|0.0001|TWO_SIDED|95.0|21.95|47.17|||ANCOVA||The point estimate was calculated as LS mean difference final values of Erythropoietin\[test\] and Erythropoietin\[reference\].|||47.17|21.95|<.0001
91588709|NCT01920594|183067254|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.2404|TWO_SIDED|95.0|-0.37|1.45|||ANCOVA||The point estimate was calculated as LS mean difference final values of Lactate Dehydrogenase\[test\] and Lactate Dehydrogenase\[reference\].|||1.45|-0.37|0.2404
91588710|NCT01920594|183067255|SUPERIORITY||Mean Difference (Final Values)|925.88||||0.0526|TWO_SIDED|95.0|-10.73|1862.49|||ANCOVA||The point estimate was calculated as LS mean difference final values of Tau Protein\[test\] and Tau Protein\[reference\].|||1862.49|-10.73|0.0526
91588711|NCT01920594|183067256|SUPERIORITY||Mean Difference (Final Values)|4.11||||0.0893|TWO_SIDED|95.0|-0.65|8.87|||ANCOVA||The point estimate was calculated as LS mean difference final values of Neuron Specific Enolase\[test\] and Neuron Specific Enolase\[reference\].|||8.87|-0.65|0.0893
91588712|NCT01920594|183067261|SUPERIORITY||Ratio of geometric mean|1.84||||0.5012|TWO_SIDED|95.0|0.3|11.32|||ANOVA|||For Troponin I||11.32|0.30|0.5012
91588713|NCT01920594|183067261|SUPERIORITY||Ratio of geometric mean|0.75||||0.8053|TWO_SIDED|95.0|0.07|8.57|||ANOVA|||For Troponin T||8.57|0.07|0.8053
91588714|NCT04498169|183067379|SUPERIORITY|With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.||||||0.0021|||||||One-sample t-test (within group)|||The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).||||0.0021
91588715|NCT04682977|183067392|SUPERIORITY||Mean difference (adjusted)|1.58|STANDARD_ERROR_OF_MEAN|0.76||0.04|TWO_SIDED|||||Sidak correction for multiple comparisons.|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.04
91588716|NCT04682977|183067393|SUPERIORITY||Mean difference (adjusted)|1.98|STANDARD_ERROR_OF_MEAN|1.75||0.26|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.26
91647975|NCT00204932|183188373|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis was based on test-retest variance of body fat mass measure by DEXA|||||<|0.05||95.0|||||ANOVA|||Analysis of variance to test CLA not equal to placebo||||<0.05
91647976|NCT00204932|183188373|SUPERIORITY||||||<|0.05|||||||ANOVA|||Pre- post treatment comparison o fat oxidation found that fat oxidation increased in CLA (4 +/- 8 g) and decreased in placebo (-7 +/- 11 g) groups during sleep. after 6 mo of supplementation.||||<0.05
91781684|NCT04816669|183442809|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67|Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.77|1.68|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 frozen-liquid LNP - BNT162b2 frozen-liquid RTU and the corresponding CI (based on the Student t distribution).|||1.68|0.77|
91588717|NCT04682977|183067394|SUPERIORITY||Mean difference (adjusted)|-1.06|STANDARD_ERROR_OF_MEAN|1.6||0.51|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.51
91588718|NCT04682977|183067395|SUPERIORITY||Mean difference (adjusted)|2.17|STANDARD_ERROR_OF_MEAN|1.78||0.23|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.23
91588719|NCT04682977|183067396|SUPERIORITY||Mean difference (adjusted)|4.65|STANDARD_ERROR_OF_MEAN|5.97||0.44|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.44
91647977|NCT02731833|183188376|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.505|-0.3|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as factor and baseline Schiff sensitivity score as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|Statistical analyses was conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.300|-0.505|<0.0001
91588720|NCT04682977|183067397|SUPERIORITY||Mean difference (adjusted)|4.37|STANDARD_ERROR_OF_MEAN|3.47||0.22|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.22
91588721|NCT04682977|183067398|SUPERIORITY||Mean difference (adjusted)|0.91|STANDARD_ERROR_OF_MEAN|1.8||0.91|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.91
91588722|NCT04682977|183067399|SUPERIORITY||Mean difference (adjusted)|0.18|STANDARD_ERROR_OF_MEAN|0.65||0.78|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.78
91588723|NCT04682977|183067400|SUPERIORITY||Mean difference (adjusted)|-0.12|STANDARD_ERROR_OF_MEAN|0.53||0.83|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.83
91588724|NCT04682977|183067401|SUPERIORITY|||||||0.67||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.67
91647978|NCT01170364|183188384|SUPERIORITY||||||<|0.004|||||||paired sample t-test, two tailed|||||||<0.004
91709083|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
91647979|NCT00368537|183188387|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|0.0||||||95.0|-8.7|8.6|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||8.6|-8.7|
91647980|NCT00368537|183188388|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.2||||||95.0|-9.6|14.0|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||14.0|-9.6|
91647981|NCT00368537|183188389|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.4||||||95.0|-9.6|14.4|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|Group comparison of eradication + presumed eradication||14.4|-9.6|
91647982|NCT00368537|183188391|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.444||95.0|-4.4|2.0|||Fisher Exact|2-sided||Intensive care unit||2.0|-4.4|0.444
91588725|NCT04682977|183067402|SUPERIORITY|||||||0.77||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.77
91588726|NCT04682977|183067403|SUPERIORITY|||||||0.79||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.79
91588727|NCT04682977|183067404|SUPERIORITY|||||||0.44||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.44
91588728|NCT04682977|183067405|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r||||||0.65
91647983|NCT01368276|183188396|SUPERIORITY_OR_OTHER||Treatment Difference|-42.9||||0.2645|TWO_SIDED|||||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||||0.2645
91647984|NCT01368276|183188397|SUPERIORITY_OR_OTHER||Treatment Difference|-1.2||||1|TWO_SIDED|95.0|-57.3|54.9||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||54.9|-57.3|1.0000
91588729|NCT04682977|183067406|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.66
91588730|NCT04682977|183067407|SUPERIORITY|||||||0.81||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.81
91647985|NCT01427920|183188406|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.25||||||95.0|0.04|0.46|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||FAS||0.46|0.04|
91647986|NCT01427920|183188407|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.26||||||95.0|0.05|0.48|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||PP||0.48|0.05|
91647987|NCT01427920|183188408|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.13||||0.659||95.0|-0.44|0.69|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.||H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).||0.69|-0.44|0.659
91588731|NCT04682977|183067408|SUPERIORITY|||||||0.89||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.89
91588732|NCT00221195|183067422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The Wilcoxin signed-rank test was used to compare the frequency of bleeds between the prophylaxis and on-demand periods.||||<0.001
91588733|NCT01383161|183067428|SUPERIORITY|||||||0.5|||||||mixed-effects general linear model|||||||0.5
91588734|NCT01383161|183067428|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91588735|NCT01383161|183067428|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
91588736|NCT01383161|183067429|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
91588737|NCT01383161|183067429|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
91588738|NCT01383161|183067429|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91588739|NCT01383161|183067430|SUPERIORITY|||||||0.05|||||||mixed-effects general linear model|||||||0.05
91588740|NCT01383161|183067430|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
91588741|NCT01383161|183067430|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91647988|NCT03341273|183188413|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-15.0|2.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D5V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D5V is 5.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||2|-15|
91588742|NCT01383161|183067431|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
91588743|NCT01383161|183067431|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||.002
91588744|NCT01383161|183067431|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
91588745|NCT01383161|183067432|SUPERIORITY|||||||0.04|||||||mixed-effects general linear model|||||||0.04
91588746|NCT01383161|183067432|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91588747|NCT01383161|183067432|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91588748|NCT01383161|183067433|SUPERIORITY|||||||0.3|||||||mixed-effects general linear model|||||||0.3
91588749|NCT01383161|183067433|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91588750|NCT01383161|183067433|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
91588751|NCT01423812|183067439|OTHER||||||<|0.05|||||||t-test, 2 sided|||p value||||<0.05
91588752|NCT01423812|183067440|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91588753|NCT04464265|183067444|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|2.0|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline. For an fMRI study of cognitive function, Desmond and Glover (J. Neurosci. Methods., 2002) reported that about 25 subjects are necessary to achieve 80% power for a 0.5% increase of activity. We analyzed 27 subjects that fulfilled the suggested optimal group size for reliable statistics in functional MRI studies (also see Thirion et al., Neuroimage, 2007).||||<0.001
91588754|NCT04464265|183067445|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-2.72|STANDARD_DEVIATION|3.17|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|||||<0.001
91588755|NCT01063829|183067446|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
91588756|NCT01063829|183067446|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
91709084|NCT03035916|183311326|OTHER|||||||0.079|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.079
91588757|NCT01063829|183067446|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
91588758|NCT01063829|183067447|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
91588759|NCT01063829|183067447|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||||||0.126
91588760|NCT01063829|183067447|SUPERIORITY_OR_OTHER|||||||0.148|||||||Log Rank|||||||0.148
91588761|NCT01063829|183067448|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
91588762|NCT01063829|183067448|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
91588763|NCT01063829|183067448|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
91588764|NCT01862640|183067452|SUPERIORITY||Least square (LS) mean difference|-3.77|||=|0.0404|TWO_SIDED|95.0|-7.38|-0.17|||Mixed-effect model repeated measure|||||-0.17|-7.38|=0.0404
91588765|NCT01862640|183067452|SUPERIORITY||LS mean difference|0.23|||=|0.9015|TWO_SIDED|95.0|-3.4|3.86|||Mixed-effect model repeated measure|||||3.86|-3.40|=0.9015
91588766|NCT01862640|183067453|SUPERIORITY||LS mean difference|-0.16|||=|0.1566|TWO_SIDED|95.0|-0.39|0.06|||Mixed-effect model repeated measure|||||0.06|-0.39|=0.1566
91588767|NCT01862640|183067453|SUPERIORITY||LS mean difference|0.09|||=|0.444|TWO_SIDED|95.0|-0.14|0.32|||Mixed-effect model repeated measure|||||0.32|-0.14|=0.4440
91588768|NCT04884763|183067454|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.567|TWO_SIDED|95.0|-0.76|1.35||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.35|-0.76|0.567
91588769|NCT04884763|183067455|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.778|TWO_SIDED|95.0|-0.91|1.21||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.21|-0.91|0.778
91588770|NCT04884763|183067456|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.105|TWO_SIDED|95.0|-0.2|1.96||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.96|-0.20|0.105
91613921|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.318||||0.001|TWO_SIDED|95.0|0.16|0.63|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.630|0.160|0.0010
91588771|NCT04884763|183067457|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.163|TWO_SIDED|95.0|-7.6|42.7||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||42.7|-7.6|0.163
91588772|NCT04884763|183067458|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.91|TWO_SIDED|95.0|-1.13|1.01||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.01|-1.13|0.910
91588773|NCT04884763|183067459|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.972|TWO_SIDED|95.0|-0.83|0.8||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.80|-0.83|0.972
91588774|NCT04884763|183067460|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.037|TWO_SIDED|95.0|0.18|5.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.43|0.18|0.037
91588775|NCT04884763|183067461|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.885|TWO_SIDED|95.0|-3.95|3.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||3.43|-3.95|0.885
91588776|NCT04884763|183067462|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.474|TWO_SIDED|95.0|-0.87|1.81||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.81|-0.87|0.474
91588777|NCT04884763|183067463|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.822|TWO_SIDED|95.0|-1.94|1.56||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.56|-1.94|0.822
91588778|NCT04884763|183067464|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.455|TWO_SIDED|95.0|-0.88|1.91||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.91|-0.88|0.455
91709085|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91781685|NCT01229267|183442817|SUPERIORITY||Vaccine Efficacy|0.638|||||TWO_SIDED|95.0|0.484|0.746|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is \>0.25.||0.746|0.484|
91588779|NCT04884763|183067465|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.467|TWO_SIDED|95.0|-12.8|27.0||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||27.0|-12.8|0.467
91588780|NCT04884763|183067466|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.755|TWO_SIDED|95.0|-0.79|1.07||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.07|-0.79|0.755
91588781|NCT04884763|183067467|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.613|TWO_SIDED|95.0|-1.18|0.71||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.71|-1.18|0.613
91588782|NCT04884763|183067468|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.003|TWO_SIDED|95.0|0.94|4.22||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||4.22|0.94|0.003
91647989|NCT03341273|183188414|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-12.0|3.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D11V is 11.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||3|-12|
91781686|NCT01229267|183442818|OTHER||Vaccine Efficacy|0.695|||||TWO_SIDED|95.0|0.49|0.818|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.818|0.490|
91781687|NCT01229267|183442819|OTHER||Vaccine Efficacy|0.735|||||TWO_SIDED|95.0|0.498|0.86|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.860|0.498|
91781688|NCT01229267|183442820|OTHER||Vaccine Efficacy|0.837|||||TWO_SIDED|95.0|0.446|0.952|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.952|0.446|
91781689|NCT01229267|183442821|OTHER||Risk Difference (RD)|0.2||||0.942|TWO_SIDED|95.0|-5.1|5.5|||Normal approximation||Miettinen \& Nurminen|||5.5|-5.1|0.942
91781690|NCT01837823|183442835|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.231||||0.054|TWO_SIDED||||||Regression, Linear|||||||0.054
91588783|NCT04884763|183067469|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.536|TWO_SIDED|95.0|-2.7|5.08||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.08|-2.70|0.536
91588784|NCT02178553|183067470|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.142|TWO_SIDED|90.0|-0.1|1.8|||t-test, 2 sided|||||1.8|-0.1|0.142
91588785|NCT02178553|183067471|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.101|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.101
91588786|NCT02178553|183067472|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.014|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.014
91588787|NCT02178553|183067473|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.375|TWO_SIDED|90.0|-0.3|1.0|||t-test, 2 sided|||||1.0|-0.3|0.375
91647990|NCT03341273|183188415|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-13.0|0.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D28V is 28.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||0|-13|
91647991|NCT03341273|183188416|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from Day 1 through Day 5 Visit. It is based on adequate clinical improvement at Day 5 Visit and solicited events from Day 1 through Day 5 Visit.|Pr(Higher DOOR in Placebo at Day 5 Visit|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.68||Missing DOOR values at Day 5 Visit were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: The sum of the probability that a participant assigned to placebo will have a higher DOOR at Day 5 visit than if assigned to the Azithromycin plus one-half the probability of equal DOORs at Day 5 Visit is 50% (i.e., no difference in DOOR at Day 5 Visit).||0.68|0.57|<0.001
91647992|NCT01717456|183188438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|6.72||0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||.05
91588788|NCT01699789|183067474|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.57|
91647993|NCT04991311|183188500|SUPERIORITY||Mean Difference (Final Values)|398.4|STANDARD_DEVIATION|581.6|=|0.0585|TWO_SIDED|95.0|-17.6|814.4|||Paired t-test (2-sided, alpha=0.05)|||The participants in both comparison groups are the same.||814.4|-17.6|= 0.0585
91588789|NCT01699789|183067475|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.48|1.26||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.26|0.48|
91588790|NCT01699789|183067476|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.97||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.|In an analysis of change from baseline in likelihood of Poor Mental Health Quality of Life, CEP showed a significant advantage at 6 months, but not at 12 months.|0.97|0.61|
91647994|NCT00054275|183188528|SUPERIORITY_OR_OTHER||proportion of pts with partial response|0.39||||0.95|TWO_SIDED|95.0|0.23|0.58|||confidence interval for partial response|Confidence interval for partial response rate using Wilson's Method||||0.58|0.23|0.95
91647995|NCT03944707|183188552|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.0698||0.6643|TWO_SIDED|80.0|-0.06|0.119||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.119|-0.060|0.6643
91647996|NCT03944707|183188556|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_DEVIATION|0.21||0.6609|TWO_SIDED|80.0|-0.35|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.18|-0.35|0.6609
91647997|NCT03944707|183188557|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|7.13||0.5107|TWO_SIDED|80.0|-9.0|9.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean morning PEF||9.1|-9.0|0.5107
91588791|NCT01699789|183067477|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.3|0.7|
91588792|NCT01699789|183067478|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
91588793|NCT01699789|183067479|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.19|2.59||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.59|1.19|
91588794|NCT01699789|183067480|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.04|1.03|
91588795|NCT01699789|183067481|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.14|1.98||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.98|1.14|
91588796|NCT01699789|183067482|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.96|0.38|
91588797|NCT01699789|183067483|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.69|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.70|0.69|
91647998|NCT03944707|183188557|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_DEVIATION|9.15||0.3611|TWO_SIDED|80.0|-15.2|8.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean evening PEF||8.1|-15.2|0.3611
91588798|NCT01699789|183067484|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.32|1.09||||||Adjusted analyses used multiply imputed data (N= 249), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||1.09|0.32|
91647999|NCT03944707|183188558|SUPERIORITY||Mean Difference (Net)|-0.133|STANDARD_DEVIATION|0.1588||0.8022|TWO_SIDED|80.0|-0.336|0.071||Probability LOU064 better than placebo|Bayesian model||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.071|-0.336|0.8022
91648000|NCT03944707|183188559|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.1573||0.6312|TWO_SIDED|80.0|-0.251|0.149||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in daytime asthma symptom score||0.149|-0.251|0.6312
91588799|NCT01699789|183067485|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.28|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.28|
91588800|NCT01699789|183067486|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.14|0.88||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.88|0.14|
91648001|NCT03944707|183188559|SUPERIORITY||Mean Difference (Net)|0.075|STANDARD_DEVIATION|0.0819||0.1752|TWO_SIDED|80.0|-0.028|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in nighttime asthma symptom score||0.180|-0.028|0.1752
91648002|NCT02444182|183188567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.21||0.015|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in Gingival index between probiotics and control groups||||0.015
91781691|NCT01837823|183442836|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.074||||0.5|TWO_SIDED||||||Pearson correlation coefficient|||for minimum lumen area site||||0.50
91781692|NCT06170242|183442872|SUPERIORITY|P-values are from analysis of covariance (ANCOVA) with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in least square (LS) means|-540.56|||<|0.0001|TWO_SIDED|95.0|-680.8|-400.33|||ANCOVA|||High Dose versus (vs) Placebo||-400.33|-680.80|<0.0001
91588801|NCT01699789|183067487|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.52|1.25|||||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.52|
91588802|NCT01699789|183067488|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.69|1.41||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition||1.41|0.69|
91588803|NCT01699789|183067489|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.46|0.70|
91588804|NCT01699789|183067490|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63|||<|0.01|TWO_SIDED|95.0|1.4|4.94|||Regression, Logistic|||Adjusted analyses used multiply imputed data (N=298), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||4.94|1.40|<.01
91588805|NCT01699789|183067491|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.66|1.21||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.21|0.66|
91588806|NCT01699789|183067492|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.61|1.4||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.40|0.61|
91588807|NCT01699789|183067493|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.34|1.25||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.34|
91588808|NCT01699789|183067494|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.3|0.82||||||Adjusted analyses used multiply imputed data (N=553), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||0.82|0.30|
91588809|NCT01699789|183067495|SUPERIORITY||Rate Ratio (RR)|2.84|||||TWO_SIDED|95.0|1.39|5.8||||||Adjusted analyses used multiply imputed data (N=588), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.||5.80|1.39|
91588810|NCT01699789|183067496|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|6.2|||||TWO_SIDED|95.0|1.5|24.9||||||Adjusted analyses used multiply imputed data (N=410), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||24.9|1.5|
91588811|NCT01699789|183067497|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.59|1.57||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.57|0.59|
91588812|NCT01699789|183067498|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.4|1.22|||||When analyzed as change from baseline, CEP showed significant reductions in likelihood of behavioral health hospitalizations at 6 months (P \< 0.01) and 12 months (P \< 0.01).|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.22|.40|
91588813|NCT01699789|183067499|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.66||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.66|.66|
91781693|NCT06170242|183442872|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-523.12|||<|0.0001|TWO_SIDED|95.0|-674.46|-371.78|||ANCOVA|||Low Dose vs Placebo||-371.78|-674.46|<0.0001
91781694|NCT06170242|183442872|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS means|-536.3|||<|0.0001|TWO_SIDED|95.0|-641.71|-430.89|||ANCOVA|||Pooled EDP-323 vs Placebo||-430.89|-641.71|<0.0001
91588814|NCT01699789|183067500|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.74|1.42||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.42|0.74|
91588815|NCT01699789|183067501|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.6|1.05||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.05|.60|
91588816|NCT01699789|183067502|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.32||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.32|0.72|
91588817|NCT01699789|183067503|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.39||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.39|0.55|
91588818|NCT01699789|183067504|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a log link function was used with adjustment for covariates.||1.29|0.65|
91588819|NCT01699789|183067505|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.2|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a linear regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.2|
91648003|NCT02444182|183188568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.09||0.909|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in plaque index between probiotics and control groups||||0.909
91588820|NCT01699789|183067506|SUPERIORITY||Rate Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.1|0.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.8|0.1|
91588821|NCT01699789|183067507|SUPERIORITY||Rate Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||3.7|0.4|
91588822|NCT01699789|183067508|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.8|
91588823|NCT01699789|183067509|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|2.1||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.1|0.5|
91588824|NCT01699789|183067510|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.7|1.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.6|0.7|
91648004|NCT01453374|183188572|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
91648005|NCT01453374|183188573|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
91648006|NCT01453374|183188574|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
91781695|NCT06170242|183442873|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.85|-2.81|||ANCOVA|||High Dose vs Placebo||-2.81|-4.85|<0.0001
91648007|NCT01453374|183188580|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED||||||Fisher Exact|||||||<0.10
91648008|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.39|TWO_SIDED|95.0|-4.29|1.68|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.68|-4.29|0.390
91709086|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91588825|NCT01699789|183067511|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.3|4.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||4.0|0.3|
91588826|NCT01699789|183067512|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.4|2.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.7|0.4|
91588827|NCT01699789|183067513|SUPERIORITY||Rate Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.2|8.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.6|0.2|
91588828|NCT01699789|183067514|SUPERIORITY||Rate Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.4|1.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.8|0.4|
91588829|NCT01699789|183067515|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.6|1.2|
91588830|NCT01699789|183067516|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.5|
91588831|NCT01699789|183067517|SUPERIORITY||Odds Ratio (OR)|2.9|||||TWO_SIDED|95.0|1.0|8.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.3|1.0|
91588832|NCT01699789|183067518|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.7|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.7|
91588833|NCT01699789|183067519|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.5|
91588834|NCT01699789|183067520|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.0|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|1.0|
91588835|NCT01699789|183067521|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
91588836|NCT01699789|183067522|SUPERIORITY||Cox Proportional Hazard|1.12|||>|0.05|TWO_SIDED|95.0|0.83|1.5|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.50|0.83|>.05
91781696|NCT06170242|183442873|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-4.16|||<|0.0001|TWO_SIDED|95.0|-5.44|-2.89|||ANCOVA|||Low Dose vs Placebo||-2.89|-5.44|<0.0001
91781697|NCT06170242|183442874|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-0.29||||0.633|TWO_SIDED|95.0|-1.5|0.92|||ANCOVA|||High Dose vs Placebo||0.92|-1.50|0.6330
91781698|NCT06170242|183442874|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-0.14||||0.8309|TWO_SIDED|95.0|-1.46|1.17|||ANCOVA|||Lose Dose vs Placebo||1.17|-1.46|0.8309
91588837|NCT01699789|183067523|SUPERIORITY||Cox Proportional Hazard|1.23|||>|0.05|TWO_SIDED|95.0|0.99|1.52|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.52|0.99|>0.05
91588838|NCT01699789|183067524|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.0|2.99||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||2.99|1.00|
91588839|NCT01699789|183067525|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|1.24|5.54||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||5.54|1.24|
91588840|NCT01786239|183067528|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Mixed Models Analysis|||||||0.0493
91588841|NCT02511678|183067529|SUPERIORITY|||||||0.0746||||||The 1-sided p-value was based on a t-test against a performance goal of -2.|t-test, 1 sided|||||||0.0746
91588842|NCT01295281|183067541|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Two catheters were tested regarding subjects' perception when using them, in a cross over design. After using each catheter for 1 week the subjects were asked: Do you experience discomfort when using your catheter?, and the subjects were supposed to answer Yes or No. The hypothesis to be investigated was that the tolerability/perception was about the same for each type of catheter, i.e. the POBE 2.0 should be non-inferior compared to PVC. H0: p(disc. POBE - Yes) = p(disc. PVC - Yes)"||||||0.0066|||||||McNemar|||The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.||||0.0066
91588843|NCT00292461|183067554|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||||||0.240
91588844|NCT00292461|183067555|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Cochran-Mantel-Haenszel|||||||0.460
91588845|NCT00292461|183067556|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Cochran-Mantel-Haenszel|||||||0.079
91588846|NCT00292461|183067557|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Cochran-Mantel-Haenszel|||||||0.860
91781699|NCT06170242|183442876|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-1.57||||0.0021|TWO_SIDED|95.0|-2.53|-0.61|||ANCOVA|||High Dose vs Placebo.||-0.61|-2.53|0.0021
91781700|NCT06170242|183442876|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-1.09||||0.0905|TWO_SIDED|95.0|-2.35|0.18|||ANCOVA|||Lose Dose vs Placebo||0.18|-2.35|0.0905
91588847|NCT03049735|183067628|SUPERIORITY||Treatment difference|54.54|||<|0.0001|TWO_SIDED|95.0|44.3|64.78||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix + E2/NETA minus placebo.|The primary efficacy analysis was the comparison of the relugolix + E2/NETA group with the placebo group with respect to responder rate.||64.78|44.3|<0.0001
91588848|NCT03049735|183067629|SUPERIORITY||Treatment difference|46.83|||<|0.0001|TWO_SIDED|95.0|37.31|56.35||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for difference is based on the normal approximation.|||56.35|37.31|<0.0001
91648009|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.264|TWO_SIDED|95.0|-1.37|4.97|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.97|-1.37|0.264
91648010|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.357|TWO_SIDED|95.0|-4.74|1.72|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.72|-4.74|0.357
91588849|NCT03049735|183067630|SUPERIORITY||Treatment difference|-61.1|STANDARD_ERROR_OF_MEAN|6.32|<|0.0001|TWO_SIDED|95.0|-73.5|-48.6||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance. Treatment difference is relugolix plus E2/NETA minus placebo.||||-48.6|-73.5|<0.0001
91588850|NCT03049735|183067631|SUPERIORITY||Treatment difference|28.26|||=|0.0377|TWO_SIDED|95.0|3.68|52.84||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||52.84|3.68|= 0.0377
91588851|NCT03049735|183067632|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|18.36|47.56||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||47.56|18.36|<0.0001
91588852|NCT03049735|183067633|SUPERIORITY||Treatment difference|-12.1|STANDARD_ERROR_OF_MEAN|7.19||0.0921|TWO_SIDED|95.0|-26.3|2.0||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||2|-26.3|0.0921
91588853|NCT03049735|183067634|SUPERIORITY||Treatment difference|-15.1|STANDARD_ERROR_OF_MEAN|3.98||0.0002|TWO_SIDED|95.0|-23.0|-7.3||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||-7.3|-23|0.0002
91588854|NCT03049735|183067635|SUPERIORITY||Treatment difference|-28.9|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-36.3|-21.5||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance level. LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||-21.5|-36.3|<0.0001
91588855|NCT03049735|183067638|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91588856|NCT03049735|183067643|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
91588857|NCT03049735|183067644|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
91588858|NCT03049735|183067645|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
91781701|NCT06170242|183442879|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-203.63|||<|0.0001|TWO_SIDED|95.0|-272.18|-135.07|||ANCOVA|||High Dose vs Placebo||-135.07|-272.18|<0.0001
91588859|NCT03049735|183067646|SUPERIORITY||||||<|0.0001||||||P-value was based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
91588860|NCT03049735|183067647|SUPERIORITY|||||||0.0377||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0377
91588861|NCT03049735|183067648|SUPERIORITY|||||||0.0117||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||0.0117
91588862|NCT03049735|183067649|SUPERIORITY|||||||0.0084||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||0.0084
91588863|NCT03049735|183067650|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588864|NCT03049735|183067651|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588865|NCT03049735|183067652|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588866|NCT03049735|183067653|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588867|NCT03049735|183067654|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between Relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
91588868|NCT03049735|183067655|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588869|NCT03049735|183067656|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
91588870|NCT03049735|183067657|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588871|NCT03049735|183067658|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588872|NCT03049735|183067660|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
91588873|NCT03049735|183067667|SUPERIORITY|||||||0.0002||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0002
91588874|NCT02146326|183067672|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
91588875|NCT02146326|183067673|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
91588876|NCT02146326|183067674|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.54
91588877|NCT02146326|183067675|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.94
91781702|NCT06170242|183442879|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-215.03|||<|0.0001|TWO_SIDED|95.0|-288.84|-141.22|||ANCOVA|||Low Dose vs Placebo||-141.22|-288.84|<0.0001
91588878|NCT02146326|183067676|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.96
91588879|NCT02146326|183067677|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
91588880|NCT02146326|183067678|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.47
91588881|NCT02146326|183067679|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.60
91588882|NCT02146326|183067680|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
91588883|NCT02146326|183067681|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.83
91588884|NCT02146326|183067682|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
91588885|NCT02146326|183067683|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
91588886|NCT02146326|183067684|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.13
91588887|NCT02146326|183067685|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.93
91588888|NCT02146326|183067686|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
91648011|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.981|TWO_SIDED|95.0|-3.5|3.42|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.42|-3.50|0.981
91648012|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.584|TWO_SIDED|95.0|-4.37|2.47|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.47|-4.37|0.584
91588889|NCT02146326|183067687|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.21
91588890|NCT02146326|183067689|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
91588891|NCT02146326|183067690|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
91588892|NCT02146326|183067691|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
91588893|NCT02146326|183067692|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
91588894|NCT02146326|183067693|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.04
91588895|NCT02146326|183067694|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.34
91588896|NCT02146326|183067695|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.71
91588897|NCT02146326|183067696|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.22
91648013|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58||||0.392|TWO_SIDED|95.0|-2.05|5.2|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.20|-2.05|0.392
91648014|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.345|TWO_SIDED|95.0|-6.34|2.24|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.24|-6.34|0.345
91588898|NCT02146326|183067697|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
91588899|NCT02146326|183067698|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
91588900|NCT02146326|183067699|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.55
91588901|NCT02146326|183067700|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.91
91588902|NCT02146326|183067701|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.48
91648015|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.922|TWO_SIDED|95.0|-4.73|4.28|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.28|-4.73|0.922
91521278|NCT03039023|182917059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.27||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.27
91588903|NCT02146326|183067702|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
91521279|NCT03039023|182917060|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.1||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.10
91521280|NCT03039023|182917060|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.0002||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.0002
91521281|NCT03039023|182917060|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
91521282|NCT03039023|182917060|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.006||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.006
91521283|NCT03039023|182917060|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.79||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.79
91521284|NCT03039023|182917061|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.28||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.28
91521285|NCT03039023|182917061|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521286|NCT03039023|182917061|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521287|NCT03039023|182917061|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521288|NCT03039023|182917061|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.11||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.11
91521289|NCT03039023|182917062|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.005||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.005
91521290|NCT03039023|182917062|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
91521291|NCT03039023|182917062|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
91521292|NCT03039023|182917062|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.009||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.009
91521293|NCT03039023|182917062|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
91521294|NCT03039023|182917063|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.93||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.93
91521295|NCT03039023|182917063|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
91521296|NCT03039023|182917063|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.003||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.003
91521297|NCT03039023|182917063|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
91521298|NCT03039023|182917063|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.99||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.99
91521299|NCT03039023|182917064|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
91521300|NCT03039023|182917064|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521301|NCT03039023|182917064|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
91521302|NCT03039023|182917064|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.001
91521303|NCT03039023|182917064|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
91521304|NCT00448448|182917082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.0267|TWO_SIDED|95.0|1.08|3.46|||Regression, Logistic|The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.||||3.46|1.08|<0.0267
91521305|NCT02684006|182917088|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0001|TWO_SIDED|95.0|0.475|0.79||2-sided p-value|Log Rank|||||0.790|0.475|0.0001
91521306|NCT02684006|182917089|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1509|TWO_SIDED|95.0|0.701|1.057||2-sided p-value|Log Rank|||||1.057|0.701|0.1509
91521307|NCT02684006|182917090|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0002|TWO_SIDED|95.0|0.563|0.84||2-sided p-value|Log Rank|||||0.840|0.563|0.0002
91521308|NCT02684006|182917091|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1338|TWO_SIDED|95.0|0.749|1.039||2-sided p-value|Log Rank|||||1.039|0.749|0.1338
91521309|NCT02684006|182917100|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.565|0.768||2-sided p-value|Log Rank|||||0.768|0.565|<.0001
91521310|NCT02684006|182917101|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.551|0.754||||||||0.754|0.551|
91588904|NCT02146326|183067703|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.77
91588905|NCT02146326|183067704|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.59
91588906|NCT02146326|183067705|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
91709087|NCT03035916|183311326|OTHER|||||||0.314||||||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.314
91781703|NCT06170242|183442880|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-3.22|||<|0.0001|TWO_SIDED|95.0|-4.05|-2.4|||ANCOVA|||High Dose vs Placebo||-2.40|-4.05|<0.0001
91781704|NCT06170242|183442880|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-3.23|||<|0.0001|TWO_SIDED|95.0|-4.11|-2.34|||ANCOVA|||Low Dose vs Placebo||-2.34|-4.11|<0.0001
91588907|NCT02146326|183067706|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.05
91648016|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.384|TWO_SIDED|95.0|-7.97|3.1|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.10|-7.97|0.384
91521311|NCT00162370|182917168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Regression, Cox|||The null hypothesis evaluated is that the scores are not associated with outcome. Of the two measures, wall motion index is considered to be the primary endpoint measure. The cardiac event rate will be summarized by categorical levels of wall motion index score and the difference in wall motion index score.||||0.014
91521312|NCT00162370|182917169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Regression, Cox|||||||<0.0001
91521313|NCT01895972|182917225|OTHER||||||<|0.001||||||The reduction from baseline in IOP was significant at all post-baseline assessment time points through Week 52.|t-test, 2 sided|||comparison vs. baseline||||<0.001
91521314|NCT04085328|182917229|NON_INFERIORITY|Predefined margin of 0.05 for noninferiority|Difference in proportion|-0.0154|||||ONE_SIDED|95.0||-0.0015|||Generalized linear model|Proportion of events was analyzed using a generalized linear model, with a logit link function, accounting for within-subject correlation.|Difference in proportion = LID015385 minus Biofinity.|||-0.0015||
91521315|NCT01422408|182917253|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.|||||<|0.001||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||<0.001
91521316|NCT01422408|182917253|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.001|TWO_SIDED|95.0|0.0|0.36||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||0.36|0|0.001
91521317|NCT01422408|182917254|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.002||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||0.002
91521318|NCT01422408|182917254|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.062|TWO_SIDED|95.0|0.0|1.09||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||1.09|0|0.062
91521319|NCT01422408|182917255|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.001
91521320|NCT01422408|182917256|OTHER|2.5% significance level to account for two co-primary endpoints.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.002
91521321|NCT01422408|182917258|OTHER|||||||0.1029||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1029
91521322|NCT01422408|182917259|OTHER|||||||0.2678||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2678
91521323|NCT01422408|182917260|OTHER|||||||0.2472||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2472
91521324|NCT01422408|182917261|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
91521325|NCT01422408|182917262|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
91588908|NCT02146326|183067707|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.06
91588909|NCT02146326|183067708|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.84
91781705|NCT06170242|183442881|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|1.44||||0.0238|TWO_SIDED|95.0|0.2|2.68|||ANCOVA|||High Dose vs Placebo||2.68|0.20|0.0238
91781706|NCT06170242|183442881|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|1.68||||0.0134|TWO_SIDED|95.0|0.36|2.99|||ANCOVA|||Low Dose vs Placebo||2.99|0.36|0.0134
91781707|NCT06170242|183442883|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-2.18||||0.0389|TWO_SIDED|95.0|-4.23|-0.12|||ANCOVA|||High Dose vs Placebo||-0.12|-4.23|0.0389
91781708|NCT06170242|183442883|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-1.31||||0.2713|TWO_SIDED|95.0|-3.73|1.1|||ANCOVA|||Low Dose vs Placebo||1.10|-3.73|0.2713
91781709|NCT06170242|183442885|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-280.61|||<|0.0001|TWO_SIDED|95.0|-404.44|-156.77|||ANCOVA|||High Dose vs Placebo||-156.77|-404.44|<0.0001
91781710|NCT06170242|183442885|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-301.15|||<|0.0001|TWO_SIDED|95.0|-428.53|-173.76|||ANCOVA|||Low Dose vs Placebo||-173.76|-428.53|<0.0001
91781711|NCT06170242|183442886|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-3.64|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.02|||ANCOVA|||High Dose vs Placebo||-2.02|-5.26|<0.0001
91781712|NCT06170242|183442886|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.35|-2.05|||ANCOVA|||Low Dose vs Placebo||-2.05|-5.35|<0.0001
91781713|NCT06170242|183442887|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-1.08||||0.0552|TWO_SIDED|95.0|-2.19|0.03|||ANCOVA|||High Dose vs Placebo||0.03|-2.19|0.0552
91781714|NCT06170242|183442887|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-0.38||||0.5599|TWO_SIDED|95.0|-1.69|0.92|||ANCOVA|||Low Dose vs Placebo||0.92|-1.69|0.5599
91781715|NCT06170242|183442888|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-1.04||||0.0307|TWO_SIDED|95.0|-1.97|-0.1|||ANCOVA|||High Dose vs Placebo||-0.10|-1.97|0.0307
91781716|NCT06170242|183442888|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-0.53||||0.4119|TWO_SIDED|95.0|-1.81|0.76|||ANCOVA|||||0.76|-1.81|0.4119
91588910|NCT02146326|183067709|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
91588911|NCT02146326|183067710|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.45
91588912|NCT03602261|183067764|OTHER|||||||0.5536|||||||Fisher Exact|||||||0.5536
91781717|NCT06170242|183442889|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-13.37||||0.0042|TWO_SIDED|95.0|-22.34|-4.4|||ANCOVA|||High Dose vs Placebo||-4.40|-22.34|0.0042
91781718|NCT06170242|183442889|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-13.19||||0.0058|TWO_SIDED|95.0|-22.38|-4.0|||ANCOVA|||Low Dose vs Placebo||-4.00|-22.38|0.0058
91781719|NCT06170242|183442890|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-18.72||||0.0026|TWO_SIDED|95.0|-30.61|-6.84|||ANCOVA|||High Dose vs Placebo||-6.84|-30.61|0.0026
91781720|NCT06170242|183442890|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-19.28||||0.0022|TWO_SIDED|95.0|-31.3|-7.26|||ANCOVA|||||-7.26|-31.30|0.0022
91588913|NCT03808688|183067780|OTHER|Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.||||||||||||||||Cohorts assessed versus baseline treatment|All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.|||
91588914|NCT02137512|183067790|SUPERIORITY|No adjustments were made for multiple comparisons.|||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91709088|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91781721|NCT02558296|183442902|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the primary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.56|<0.0001
91781722|NCT02558296|183442903|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.4||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories, history of heart failure, treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.40|-0.65|<0.0001
91781723|NCT02558296|183442904|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in body weight from baseline to Week 48 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.07|-2.24||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c and eGFR, history of heart failure, insulin use (Y/N), treatment, visit and baseline body weight as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in body weight from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-2.24|-3.07|<0.0001
91781724|NCT02558296|183442905|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in systolic blood pressure from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.96||||0.0112|TWO_SIDED|95.0|-5.51|-0.42||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c, GFR categories, BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline SBP as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in systolic blood pressure from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.42|-5.51|0.0112
91781725|NCT02558296|183442906|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.50|<0.0001
91781726|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.49|-0.63|<0.0001
91781727|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
91588915|NCT02137512|183067790|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588916|NCT02137512|183067790|SUPERIORITY|||||||0.31||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.31
91588917|NCT02137512|183067791|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
91588918|NCT02137512|183067791|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588919|NCT02137512|183067791|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588920|NCT02137512|183067792|SUPERIORITY|||||||0.1||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.10
91588921|NCT02137512|183067792|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588922|NCT02137512|183067792|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588923|NCT02137512|183067793|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588924|NCT02137512|183067793|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588925|NCT02137512|183067793|SUPERIORITY|||||||0.91||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.91
91588926|NCT02137512|183067794|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588927|NCT02137512|183067794|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588928|NCT02137512|183067794|SUPERIORITY|||||||0.2||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.20
91588929|NCT02137512|183067795|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
91588930|NCT02137512|183067795|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588931|NCT02137512|183067795|SUPERIORITY|||||||0.49||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.49
91781728|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
91588932|NCT02137512|183067796|SUPERIORITY|||||||0.009||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.009
91588933|NCT02137512|183067796|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
91588934|NCT02137512|183067796|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
91588935|NCT02137512|183067797|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
91588936|NCT02137512|183067797|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
91588937|NCT02137512|183067797|SUPERIORITY|||||||0.18||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.18
91709089|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91588938|NCT02137512|183067798|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
91588939|NCT02137512|183067798|SUPERIORITY|||||||0.54||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.54
91588940|NCT02137512|183067798|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
91588941|NCT02137512|183067799|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
91588942|NCT02137512|183067799|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588943|NCT02137512|183067799|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
91588944|NCT02137512|183067800|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588945|NCT02137512|183067800|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588946|NCT02137512|183067800|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
91588947|NCT02137512|183067801|SUPERIORITY|||||||0.13||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.13
91588948|NCT02137512|183067801|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588949|NCT02137512|183067801|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588950|NCT02137512|183067802|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588951|NCT02137512|183067802|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588952|NCT02137512|183067802|SUPERIORITY|||||||0.41||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.41
91588953|NCT02137512|183067803|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588954|NCT02137512|183067803|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588955|NCT02137512|183067803|SUPERIORITY|||||||0.12||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.12
91588956|NCT02137512|183067804|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
91588957|NCT02137512|183067804|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588958|NCT02137512|183067804|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
91588959|NCT02137512|183067805|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588960|NCT02137512|183067805|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
91588961|NCT02137512|183067805|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
91588962|NCT02137512|183067806|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588963|NCT02137512|183067806|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588964|NCT02137512|183067806|SUPERIORITY|||||||0.11||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.11
91588965|NCT02137512|183067807|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
91588966|NCT02137512|183067807|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
91588967|NCT02137512|183067807|SUPERIORITY|||||||0.61||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.61
91588968|NCT02137512|183067808|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588969|NCT02137512|183067808|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588970|NCT02137512|183067808|SUPERIORITY|||||||0.29||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.29
91588971|NCT02137512|183067809|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588972|NCT02137512|183067809|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
91588973|NCT02137512|183067809|SUPERIORITY||||||>|0.99||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||>0.99
91588974|NCT02137512|183067810|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
91588975|NCT02137512|183067810|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588976|NCT02137512|183067810|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
91588977|NCT02137512|183067811|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
91588978|NCT02137512|183067811|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588979|NCT02137512|183067811|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588980|NCT02137512|183067812|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588981|NCT02137512|183067812|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588982|NCT02137512|183067812|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
91588983|NCT02137512|183067813|SUPERIORITY|||||||0.04||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.04
91588984|NCT02137512|183067813|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588985|NCT02137512|183067813|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588986|NCT02137512|183067814|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
91648017|NCT00996918|183188593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.961|TWO_SIDED|95.0|-6.08|5.78|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.78|-6.08|0.961
91781729|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.37|-0.56|<0.0001
91781730|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.31||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.31|-0.54|<0.0001
91781731|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.51|-0.27||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.27|-0.51|<0.0001
91781732|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.3||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.30|-0.56|<0.0001
91588987|NCT02137512|183067814|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588988|NCT02137512|183067814|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588989|NCT02137512|183067815|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 1 sided|||||||<0.001
91588990|NCT02137512|183067815|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588991|NCT02137512|183067815|SUPERIORITY|||||||0.53||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.53
91588992|NCT02137512|183067816|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
91588993|NCT02137512|183067816|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588994|NCT02137512|183067816|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588995|NCT02137512|183067817|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588996|NCT02137512|183067817|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588997|NCT02137512|183067817|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588998|NCT02137512|183067818|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91588999|NCT02137512|183067818|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589000|NCT02137512|183067818|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
91589001|NCT02137512|183067819|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
91589002|NCT02137512|183067819|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589003|NCT02137512|183067819|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589004|NCT02137512|183067820|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589005|NCT02137512|183067820|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
91781733|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.23||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.23|-0.54|<0.0001
91781734|NCT02558296|183442906|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.27||||0.0045|TWO_SIDED|95.0|-0.47|-0.07||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.07|-0.47|0.0045
91781735|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.55|-1.15||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.15|-1.55|<0.0001
91781736|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.18|-1.61|<0.0001
91781737|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.16||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.16|-1.61|<0.0001
91781738|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.89||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.89|-1.41|<0.0001
91781739|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.98||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.98|-1.48|<0.0001
91781740|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.72||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.72|-1.27|<0.0001
91589006|NCT02137512|183067820|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
91589007|NCT02137512|183067821|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589008|NCT02137512|183067821|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589009|NCT02137512|183067821|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
91589010|NCT02137512|183067822|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
91589011|NCT02137512|183067822|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
91648018|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.837|TWO_SIDED|95.0|-1.91|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-1.91|0.837
91648019|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.064|TWO_SIDED|95.0|-0.13|4.41|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.41|-0.13|0.064
91648020|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-2.32|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-2.32|0.990
91589012|NCT02137512|183067822|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
91589013|NCT02137512|183067823|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
91589014|NCT02137512|183067823|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589015|NCT02137512|183067823|SUPERIORITY|||||||0.71||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.71
91589016|NCT02137512|183067824|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589017|NCT02137512|183067824|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589018|NCT02137512|183067824|SUPERIORITY|||||||0.39||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.39
91648021|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.817|TWO_SIDED|95.0|-2.22|2.82|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.82|-2.22|0.817
91648022|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.697|TWO_SIDED|95.0|-2.04|3.05|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-2.04|0.697
91781741|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.90|-1.50|<0.0001
91589019|NCT02137512|183067825|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589020|NCT02137512|183067825|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589021|NCT02137512|183067825|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
91589022|NCT02137512|183067826|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
91589023|NCT02137512|183067826|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
91589024|NCT02137512|183067826|SUPERIORITY|||||||0.86||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.86
91589025|NCT02137512|183067827|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589026|NCT02137512|183067827|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589027|NCT02137512|183067827|SUPERIORITY|||||||0.74||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.74
91589028|NCT02137512|183067828|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589029|NCT02137512|183067828|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589030|NCT02137512|183067828|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
91589031|NCT02137512|183067829|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
91589032|NCT02137512|183067829|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
91589033|NCT02137512|183067829|SUPERIORITY|||||||0.68||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.68
91589034|NCT02137512|183067830|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
91589035|NCT02137512|183067830|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
91589036|NCT02137512|183067830|SUPERIORITY|||||||0.62||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.62
91589037|NCT02137512|183067831|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589038|NCT02137512|183067831|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
91589039|NCT02137512|183067831|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
91589040|NCT02137512|183067832|SUPERIORITY|||||||0.67||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.67
91589041|NCT02137512|183067832|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
91589042|NCT02137512|183067832|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
91589043|NCT02137512|183067833|SUPERIORITY|||||||0.25||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.25
91648023|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.158|TWO_SIDED|95.0|-0.76|4.63|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.63|-0.76|0.158
91648024|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.829|TWO_SIDED|95.0|-4.06|3.26|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.26|-4.06|0.829
91589044|NCT02137512|183067834|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
91589045|NCT02137512|183067835|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589046|NCT02137512|183067836|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589047|NCT02137512|183067837|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589048|NCT02137512|183067838|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
91589049|NCT02137512|183067839|SUPERIORITY|||||||0.01||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.01
91589050|NCT02137512|183067840|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
91589051|NCT02137512|183067841|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
91589052|NCT01215175|183067845|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
91589053|NCT01215175|183067846|OTHER||Risk Difference (RD)|8.2||||||95.0|-7.9|26.6|||||Miettinen \& Nurminen method|||26.6|-7.9|
91589054|NCT01215175|183067846|OTHER||Risk Difference (RD)|3.6||||||95.0|-15.5|22.9|||||Miettinen \& Nurminen method|||22.9|-15.5|
91589055|NCT01215175|183067847|OTHER||Risk Difference (RD)|0.0||||||95.0|-11.5|11.5|||||Miettinen \& Nurminen method|||11.5|-11.5|
91589056|NCT01215175|183067848|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.2|10.6|||||Miettinen \& Nurminen method|||10.6|-12.2|
91589057|NCT01215175|183067848|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.3|12.3|||||Miettinen \& Nurminen method|||12.3|-12.3|
91589058|NCT01215175|183067849|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
91589059|NCT01215175|183067850|OTHER||Risk Difference (RD)|9.8||||||95.0|-10.6|30.9|||||Miettinen \& Nurminen method|||30.9|-10.6|
91589060|NCT01215175|183067850|OTHER||Risk Difference (RD)|3.6||||||95.0|-19.1|26.0|||||Miettinen \& Nurminen method|||26.0|-19.1|
91589061|NCT03872453|183067860|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|4.2||||0.1214|TWO_SIDED|98.3|-2.3|10.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||10.7|-2.3|0.1214
91589062|NCT03872453|183067860|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.0||||0.0113|TWO_SIDED|98.3|0.4|13.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.7|0.4|0.0113
91589063|NCT03872453|183067860|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.7||||0.0055|TWO_SIDED|98.3|1.1|14.3||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||14.3|1.1|0.0055
91589064|NCT03872453|183067861|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|5.4||||0.1162|TWO_SIDED|98.3|-2.8|13.6||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.6|-2.8|0.1162
91589065|NCT03872453|183067861|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.3||||0.0155|TWO_SIDED|98.3|0.1|16.5||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||16.5|0.1|0.0155
91589066|NCT03872453|183067861|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.9||||0.0094|TWO_SIDED|98.3|0.7|17.0||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||17.0|0.7|0.0094
91648025|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.95|TWO_SIDED|95.0|-3.69|3.93|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|-3.69|0.950
91648026|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.816|TWO_SIDED|95.0|-5.35|4.23|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.23|-5.35|0.816
91648027|NCT00996918|183188594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.751|TWO_SIDED|95.0|-4.32|5.96|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.96|-4.32|0.751
91648028|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.967|TWO_SIDED|95.0|-7.22|7.53|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.53|-7.22|0.967
91648029|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.593|TWO_SIDED|95.0|-5.72|9.98|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.98|-5.72|0.593
91648030|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.968|TWO_SIDED|95.0|-7.32|7.62|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.62|-7.32|0.968
91648031|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92||||0.473|TWO_SIDED|95.0|-10.92|5.08|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.08|-10.92|0.473
91648032|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.63|TWO_SIDED|95.0|-9.91|6.02|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.02|-9.91|0.630
91648033|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.293|TWO_SIDED|95.0|-13.02|3.95|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-13.02|0.293
91648034|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.733|TWO_SIDED|95.0|-7.28|10.33|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.33|-7.28|0.733
91648035|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81||||0.55|TWO_SIDED|95.0|-12.06|6.45|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.45|-12.06|0.550
91648036|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.902|TWO_SIDED|95.0|-11.04|12.5|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||12.50|-11.04|0.902
91648037|NCT00996918|183188595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07||||0.43|TWO_SIDED|95.0|-17.75|7.61|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.61|-17.75|0.430
91709090|NCT03035916|183311326|OTHER|||||||0.087|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.087
91589067|NCT03872453|183067862|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.1||||0.0439|TWO_SIDED|98.3|-1.3|15.4||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.4|-1.3|0.0439
91589068|NCT03872453|183067862|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.5||||0.0302|TWO_SIDED|98.3|-0.8|15.9||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.9|-0.8|0.0302
91589069|NCT02960113|183067884|OTHER|||||||0.98||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing nausea equal between groups||||0.98
91589070|NCT02960113|183067885|OTHER|||||||0.9||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing vomiting equal across groups||||0.90
91589071|NCT02960113|183067886|OTHER|Null hypothesis: Mean scores equal across treatment groups||||||0.026|||||||ANOVA|||||||0.026
91589072|NCT02960113|183067887|OTHER|Null hypothesis: means equal across treatment groups||||||0.91|||||||ANOVA|||||||0.91
91589073|NCT02960113|183067888|OTHER|||||||0.8|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.80
91648038|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.683|TWO_SIDED|95.0|-6.01|3.95|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-6.01|0.683
91589074|NCT02960113|183067889|OTHER|||||||0.82|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.82
91589075|NCT02960113|183067890|OTHER|||||||0.93|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.93
91648039|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.177|TWO_SIDED|95.0|-1.68|9.06|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.06|-1.68|0.177
91781742|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.82||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.82|-1.49|<0.0001
91589076|NCT02960113|183067891|OTHER|Null hypothesis: percent of vomiting equal across treatment groups||||||0.55|||||||Chi-squared|d.f.=2||||||0.55
91589077|NCT02960113|183067892|OTHER|||||||0.71|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.71
91589078|NCT02960113|183067893|OTHER|||||||0.55|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.55
91589079|NCT02960113|183067894|OTHER|||||||0.2|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.20
91589080|NCT00863109|183067896|SUPERIORITY_OR_OTHER|||||||0.027|||||||Student´s t-test for paired samples|||Within-group comparison of Worry domain between BL Visit and WK72 Visit||||0.027
91589081|NCT00863109|183067897|SUPERIORITY_OR_OTHER|||||||0.038|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in MCS||||0.038
91589082|NCT00863109|183067898|SUPERIORITY_OR_OTHER|||||||0.014|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Emotional Function domain||||0.014
91589083|NCT00863109|183067898|SUPERIORITY_OR_OTHER|||||||0.009|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Worry domain||||0.009
91589084|NCT00863109|183067898|SUPERIORITY_OR_OTHER|||||||0.022|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in CLDQ-HCV Global domain||||0.022
91589085|NCT00702845|183067923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.2|3.9|||ANOVA|||||3.9|1.2|<0.001
91589086|NCT00440700|183067941|SUPERIORITY_OR_OTHER||Slope|15.5|||<|0.05||95.0|||||Mixed Models Analysis|||Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.||||<0.05
91589087|NCT00440700|183067943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.61|<|0.05|ONE_SIDED|95.0|||||Kruskal-Wallis||Usual care was the reference comparison group.|Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.||||<0.05
91589088|NCT00440700|183067944|SUPERIORITY_OR_OTHER||Slope|5.0|||<|0.05||95.0|||||Mixed Models Analysis|||Cortisol levels were compared among all 3 groups.||||<0.05
91589089|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.026||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R' and represented in the text as adjusted p-value.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60 years and \>/= 60 years) to facilitate comparison.||||0.026
91589090|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.496||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||0.496
91589091|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05|||||||Regression, Linear|||The influence of age on leptin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
91589092|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
91589093|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
91589094|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin, leptin, IGF1 and 2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||>0.05
91589095|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.014||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.014
91589096|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.006||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of leptin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.006
91589097|NCT04697264|183067947|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.019||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of IGF1 and IGF2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.019
91648040|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.734|TWO_SIDED|95.0|-6.03|4.25|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.25|-6.03|0.734
91648041|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.595|TWO_SIDED|95.0|-7.06|4.05|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.05|-7.06|0.595
91781743|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.63||||0.0008|TWO_SIDED|95.0|-1.01|-0.24||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.24|-1.01|0.0008
91648042|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.409|TWO_SIDED|95.0|-7.95|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-7.95|0.409
91589098|NCT04697264|183067948|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.033||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of LVSI on adiponectin levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of LVSI) to facilitate comparisons.||||0.033
91589099|NCT04697264|183067948|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.015||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of MELF on TNF levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of MELF) to facilitate comparisons.||||0.015
91589100|NCT04697264|183067948|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of tumour grade (Grade 1/2), stage (Stage 1/ \>/=1), histology (type 1 and type 2), and MSI (presence or absence) on the biomarker levels (adiponectin, leptin, IGF 1 and 2, IL6 and TNF) were assessed using multivariate linear regression, with binary categorisations to facilitate comparisons.||||>0.05
91589101|NCT04697264|183067949|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.0001
91589102|NCT04697264|183067950|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||>0.05
91589103|NCT04697264|183067951|OTHER||||||<|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.05
91589104|NCT04697264|183067952|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the study population at baseline."||||>0.05
91589105|NCT04697264|183067952|OTHER|||||||0.09||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the study population at baseline."||||0.09
91589106|NCT04697264|183067952|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the association between IL6, TNFα, IGF1, and IGF2 and the BMI of the study population at baseline."||||>0.05
91589107|NCT04697264|183067953|OTHER|||||||0.004||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the control population at baseline."||||0.004
91648043|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.368|TWO_SIDED|95.0|-8.73|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-8.73|0.368
91648044|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.458|TWO_SIDED|95.0|-4.01|8.89|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||8.89|-4.01|0.458
91648045|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.76|TWO_SIDED|95.0|-7.77|5.68|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.68|-7.77|0.760
91648046|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.597|TWO_SIDED|95.0|-5.67|9.86|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.86|-5.67|0.597
91709091|NCT03035916|183311326|OTHER|||||||0.023|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.023
91589108|NCT04697264|183067953|OTHER|||||||0.0002||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the control population at baseline."||||0.0002
91781744|NCT02558296|183442907|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.5||||0.0462|TWO_SIDED|95.0|-1.09|0.08||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||0.08|-1.09|0.0462
91589109|NCT04697264|183067953|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between IL6, TNFα, IGF1, and IGF2 and the BMI of the control population at baseline."||||>0.05
91589110|NCT04697264|183067954|OTHER|||||||0.0007||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||||||0.0007
91589111|NCT04697264|183067955|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||Leptin levels were compared between the day 0 and 6 months post-operative bloods.||||>0.05
91589112|NCT04697264|183067955|OTHER|||||||0.004||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF1 levels were compared between the day 0 and 6 months post-operative bloods.||||0.004
91589113|NCT04697264|183067955|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF2 levels were compared between the day 0 and 6 months post-operative bloods.||||<0.0001
91589114|NCT04697264|183067957|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.0001
91589115|NCT04697264|183067957|OTHER||||||<|0.05|||||||t-test, 2 sided|||Expression of leptin and their receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.05
91648047|NCT00996918|183188596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.501|TWO_SIDED|95.0|-11.24|5.5|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.50|-11.24|0.501
91648048|NCT00996918|183188597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.183|TWO_SIDED|95.0|-8.91|1.71|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.71|-8.91|0.183
91781745|NCT02558296|183442908|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||0.41|0.22|<0.0001
91781746|NCT02558296|183442909|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.35|0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during entire study.|||0.49|0.35|<0.0001
91781747|NCT02558296|183442910|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0005|TWO_SIDED|95.0|1.33|3.11||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the ratio of bexagliflozin over placebo.|||3.11|1.33|0.0005
91589116|NCT04697264|183067957|OTHER||||||>|0.05|||||||t-test, 2 sided|||Expression of adiponectin receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||>0.05
91589117|NCT04697264|183067958|OTHER|||||||0.0002|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and lymph node tissue using qRT-PCR.||||0.0002
91589118|NCT04697264|183067958|OTHER|||||||0.011|||||||t-test, 2 sided|||Expression of leptin was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.011
91589119|NCT04697264|183067958|OTHER|||||||0.009|||||||t-test, 2 sided|||The expression of IL6 receptor (IL6R) was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.009
91589120|NCT04697264|183067958|OTHER||||||>|0.05|||||||t-test, 2 sided|||The expression of adiponectin receptor, leptin receptor, IGF1 and IGF 2 receptors, IL6, TNF, IGF1 and IGF2 were studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||>0.05
91589121|NCT04697264|183067959|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating adiponectin levels and the expression of these markers and their receptors in endometrial tissue were compared using correlation studies.||||>0.05
91589122|NCT04697264|183067960|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating leptin, IGF1 and IGF2 levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
91589123|NCT04697264|183067961|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating IL6 and TNF levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
91589124|NCT00813319|183067968|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion condition||||>.05
91589125|NCT00813319|183067969|SUPERIORITY_OR_OTHER||||||=|0.52|||||||Chi-squared|||||||=.52
91589126|NCT00813319|183067970|SUPERIORITY_OR_OTHER||||||=|0.12|||||||Chi-squared|Degrees of freedom = 2||This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)||||=.12
91589127|NCT03434353|183067971|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-30.4|26.4|||||The percentage difference (Group 1 - Group 2) \& corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative).|||26.4|-30.4|
91589128|NCT03434353|183067971|OTHER||Percentage Difference|-24.7|||||TWO_SIDED|95.0|-49.2|-0.2|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||-0.2|-49.2|
91589129|NCT03434353|183067971|OTHER||Percentage Difference|-17.8|||||TWO_SIDED|95.0|-43.7|8.2|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||8.2|-43.7|
91589130|NCT03434353|183067973|OTHER||Percentage Difference|-16.6|||||TWO_SIDED|95.0|-37.7|4.4|||||The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.7|
91589131|NCT03434353|183067973|OTHER||Percentage Difference|-16.9|||||TWO_SIDED|95.0|-38.1|4.3|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.3|-38.1|
91589132|NCT03434353|183067973|OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-37.9|4.4|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.9|
91589133|NCT03739762|183067989|SUPERIORITY||Mean Difference (Final Values)|-31.85||||0.003|TWO_SIDED|95.0|-52.91|-10.79|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||The sample size of 284 ensured 90% power to detect a 41-minute difference in sitting time between I-STAND and the attention control from baseline to 6 months, assuming a standard deviation (SD) of 97 minutes/day for change in sitting time (based on our pilot data), and 15% loss to follow-up. Sample and power calculations were performed using R software version 3.5 \[39\] via simulation, assuming specified SDs and differences between means.||-10.79|-52.91|0.003
91589134|NCT03739762|183067990|SUPERIORITY||Mean Difference (Final Values)|-3.48||||0.033|TWO_SIDED|95.0|-6.68|-0.28|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||-0.28|-6.68|.033
91589135|NCT03739762|183067991|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.784|TWO_SIDED|95.0|-1.63|2.16|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.16|-1.63|.784
91781748|NCT02558296|183442911|SUPERIORITY||Hazard Ratio (HR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.4|2.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during the entire study.|||2.38|1.40|<0.0001
91781749|NCT02558296|183442912|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0803|TWO_SIDED|95.0|0.33|1.2||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.20|0.33|0.0803
91781750|NCT02558296|183442912|SUPERIORITY||Odds Ratio (OR)|0.47||||0.0272|TWO_SIDED|95.0|0.22|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.01|0.22|0.0272
91781751|NCT02558296|183442912|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0757|TWO_SIDED|95.0|0.34|1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.18|0.34|0.0757
91589136|NCT03739762|183067992|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.927|TWO_SIDED|95.0|-2.61|2.38|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.38|-2.61|.927
91589137|NCT03739762|183067993|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.916|TWO_SIDED|95.0|-0.42|0.47|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.47|-0.42|.916
91589138|NCT03739762|183067994|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.325|TWO_SIDED|95.0|-1.09|0.36|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.36|-1.09|.325
91709092|NCT03035916|183311326|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91648049|NCT00996918|183188597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.92|TWO_SIDED|95.0|-5.92|5.35|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.35|-5.92|0.920
91648050|NCT00996918|183188597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||0.133|TWO_SIDED|95.0|-11.52|1.53|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.53|-11.52|0.133
91648051|NCT00996918|183188597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.505|TWO_SIDED|95.0|-4.55|9.22|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.22|-4.55|0.505
91648052|NCT00996918|183188597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.86||||0.003|TWO_SIDED|95.0|-21.46|-4.25|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||-4.25|-21.46|0.003
91648053|NCT00996918|183188597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.76|TWO_SIDED|95.0|-7.95|10.88|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.88|-7.95|0.760
91648054|NCT00996918|183188598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||0.373|TWO_SIDED|95.0|-6.68|2.52|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.52|-6.68|0.373
91648055|NCT00996918|183188598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.677|TWO_SIDED|95.0|-5.92|3.86|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.86|-5.92|0.677
91648056|NCT00996918|183188598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.28|TWO_SIDED|95.0|-9.61|2.8|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.80|-9.61|0.280
91589139|NCT02267603|183067999|OTHER|The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.||||||||||||||||The protocol was designed w/ a standard Simon 2 stage design. Null hypothesis that true response rate is 5% was tested against a 1-sided alternative. In stage 1, 9 patients were accrued. If no responses in these 9 patients, study was to stop. Otherwise,15 more patients were to be accrued for a total of 24 patients. Study was amended to increase number of patients to 50, following discussion w/ pharmaceutical collaborator and FDA.|ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.|||
91589140|NCT01346488|183068018|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589141|NCT01346488|183068018|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589142|NCT01346488|183068018|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589143|NCT01346488|183068018|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91589144|NCT01346488|183068018|SUPERIORITY_OR_OTHER|||||||1||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||1.0000
91521326|NCT01422408|182917263|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
91589145|NCT01346488|183068018|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589146|NCT01346488|183068019|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589147|NCT01346488|183068019|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589148|NCT01346488|183068019|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589149|NCT01346488|183068019|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91589150|NCT01346488|183068019|SUPERIORITY_OR_OTHER|||||||0.0054||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0054
91589151|NCT01346488|183068019|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91781752|NCT02558296|183442912|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0273|TWO_SIDED|95.0|0.23|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.01|0.23|0.0273
91589152|NCT01346488|183068020|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||<0.0001
91589153|NCT01346488|183068020|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
91589154|NCT01346488|183068020|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589155|NCT01346488|183068020|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
91521327|NCT01422408|182917264|OTHER|||||||0.6587||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6587
91521328|NCT01422408|182917265|OTHER|||||||0.8772||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8772
91521329|NCT01422408|182917266|OTHER|||||||0.7395||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7395
91521330|NCT01422408|182917267|OTHER|||||||0.9618||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9618
91521331|NCT01422408|182917268|OTHER|||||||0.5113||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.5113
91521332|NCT01422408|182917269|OTHER|||||||0.8833||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8833
91521333|NCT01422408|182917270|OTHER|||||||0.7983||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7983
91521334|NCT01422408|182917271|OTHER|||||||0.4937||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.4937
91521335|NCT01422408|182917272|OTHER|||||||0.9106||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9106
91521336|NCT01422408|182917273|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
91589156|NCT01346488|183068020|SUPERIORITY_OR_OTHER|||||||0.0592||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0592
91589157|NCT01346488|183068020|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589158|NCT01346488|183068021|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589159|NCT01346488|183068021|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
91589160|NCT01346488|183068021|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||<0.0001
91589161|NCT01346488|183068021|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
91589162|NCT01346488|183068021|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
91589163|NCT01346488|183068021|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589164|NCT01346488|183068022|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589165|NCT01346488|183068022|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589166|NCT01346488|183068022|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589167|NCT01346488|183068022|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91589168|NCT01346488|183068022|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
91589169|NCT01346488|183068022|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589170|NCT01346488|183068023|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||<0.0001
91589171|NCT01346488|183068023|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
91589172|NCT01346488|183068023|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
91589173|NCT01346488|183068023|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
91589174|NCT01346488|183068023|SUPERIORITY_OR_OTHER||||||=|0.0005||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||= 0.0005
91589175|NCT01346488|183068023|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
91589176|NCT01346488|183068024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589177|NCT01346488|183068024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589178|NCT01346488|183068024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589179|NCT01346488|183068024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91648057|NCT00996918|183188598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.95|TWO_SIDED|95.0|-6.34|6.76|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.76|-6.34|0.950
91781753|NCT02919995|183442922|OTHER||Contrast ratio|1.038||||0.0196|TWO_SIDED|95.0|1.007|1.07|||ANCOVA|||||1.07|1.007|0.0196
91781754|NCT02919995|183442922|OTHER||Contrast ratio|1.024||||0.0802|TWO_SIDED|95.0|0.997|1.052|||ANCOVA|||||1.052|0.997|0.0802
91589180|NCT01346488|183068024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
91589181|NCT01346488|183068024|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589182|NCT01346488|183068025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
91589183|NCT01346488|183068025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
91589184|NCT01346488|183068025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
91589185|NCT01346488|183068025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
91589186|NCT01346488|183068025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
91589187|NCT01346488|183068025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
91589188|NCT01346488|183068026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589189|NCT01346488|183068026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589190|NCT01346488|183068026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589191|NCT01346488|183068026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91589192|NCT01346488|183068026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
91589193|NCT01346488|183068026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91781755|NCT02919995|183442922|OTHER||Contrast ratio|0.986||||0.3487|TWO_SIDED|95.0|0.957|1.017|||ANCOVA|||||1.017|0.957|0.3487
91781756|NCT02919995|183442923|OTHER||Contrast ratio|1.072||||0.0043|TWO_SIDED|95.0|1.026|1.12|||ANCOVA|||||1.12|1.026|0.0043
91589194|NCT01346488|183068027|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
91589195|NCT01346488|183068027|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
91589196|NCT01346488|183068027|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
91589197|NCT01346488|183068027|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
91589198|NCT01346488|183068027|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
91589199|NCT01346488|183068027|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
91589200|NCT01346488|183068028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589201|NCT01346488|183068028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589202|NCT01346488|183068028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589203|NCT01346488|183068028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91589204|NCT01346488|183068028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
91589205|NCT01346488|183068028|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589206|NCT01346488|183068029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
91589207|NCT01346488|183068029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
91589208|NCT01346488|183068029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
91648058|NCT00996918|183188598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.06||||0.13|TWO_SIDED|95.0|-23.16|3.05|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-23.16|0.130
91589209|NCT01346488|183068029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
91589210|NCT01346488|183068029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
91589211|NCT01346488|183068029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
91589212|NCT01346488|183068030|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
91589213|NCT01346488|183068030|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
91589214|NCT01346488|183068030|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
91589215|NCT01346488|183068030|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
91589216|NCT01346488|183068030|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
91589217|NCT01346488|183068030|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
91589218|NCT01008696|183068033|SUPERIORITY_OR_OTHER|||||||0.8849||||||Homozygous extensive metabolizer|Chi-squared|||||||0.8849
91648059|NCT00996918|183188598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.732|TWO_SIDED|95.0|-11.97|16.94|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||16.94|-11.97|0.732
91709093|NCT03035916|183311327|OTHER|||||||0.384|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.384
91781757|NCT02919995|183442923|OTHER||Contrast ratio|1.055||||0.0109|TWO_SIDED|95.0|1.014|1.096|||ANCOVA|||||1.096|1.014|0.0109
91589219|NCT01008696|183068033|SUPERIORITY_OR_OTHER|||||||0.865||||||Heterozygous extensive metabolizer|Chi-squared|||||||0.8650
91589220|NCT01008696|183068033|SUPERIORITY_OR_OTHER|||||||0.266||||||Poor metabolizer|Chi-squared|||||||0.2660
91589221|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.7734||||||Change at Day 57: Heartburn|Wilcoxon rank-sum test|||||||0.7734
91589222|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.6414||||||Change at Day 57: Regurgitation|Wilcoxon rank-sum test|||||||0.6414
91589223|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.7809||||||Change at Day 57: Globus sensation|Wilcoxon rank-sum test|||||||0.7809
91589224|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.8294||||||Change at Day 57: Chronic cough|Wilcoxon rank-sum test|||||||0.8294
91589225|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.9874||||||Change at Day 57: Epigastric pain|Wilcoxon rank-sum test|||||||0.9874
91589226|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.2776||||||Change at Day 57: Non cardiac chest pain|Wilcoxon rank-sum test|||||||0.2776
91589227|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.6295||||||Change at Day 57: Hoarseness|Wilcoxon rank-sum test|||||||0.6295
91589228|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.5335||||||Change at Day 57: Dysphagia|Wilcoxon rank-sum test|||||||0.5335
91589229|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.8068||||||Change at Day 57: Abdominal distension|Wilcoxon rank-sum test|||||||0.8068
91589230|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.568||||||Change at Day 57: Bloating|Wilcoxon rank-sum test|||||||0.5680
91589231|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.5913||||||Change at Day 57: Post-prandial discomfort|Wilcoxon rank-sum test|||||||0.5913
91589232|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.5566||||||Change at Day 57: Early satiety|Wilcoxon rank-sum test|||||||0.5566
91589233|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.7047||||||Change at Day 57: Nausea|Wilcoxon rank-sum test|||||||0.7047
91589234|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.3654||||||Change at Day 57: Vomitting|Wilcoxon rank-sum test|||||||0.3654
91589235|NCT01008696|183068034|SUPERIORITY_OR_OTHER|||||||0.531||||||Change at Day 57: Belching|Wilcoxon rank-sum test|||||||0.5310
91589236|NCT01008696|183068035|SUPERIORITY_OR_OTHER|||||||0.5032|||||||Wilcoxon rank-sum test|||||||0.5032
91589237|NCT01621230|183068052|OTHER|The median (first and third quartile) lengths of the second stage of labor were estimated at 28min (15, 58) in women without epidural analgesia. Assuming a one-third increase in the length of the second stage to 37min due to epidural bupivacaine, a sample size of 155 per arm (310 total) was required for 80% power to detect such a difference using a two-sided Wilcoxon rank sum test.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91589238|NCT01621230|183068055|OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||.55
91589239|NCT01621230|183068056|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||.57
91589240|NCT02856893|183068076|OTHER|The decision rule is based on confidence intervals. The treatment strategy will be considered feasible (H0 is rejected) if the lower bound of the 84% two-sided confidence interval of the PFS rate at 18 months is greater than 40%.|Kaplan-Meier survival rate|67.2|||||TWO_SIDED|84.0|56.4|75.9|||||"The population parameter is PFS Rate at 18 months in the Gefitinib till + blood test/progression then Osimertinib arm. The decision rule is based on the lower bound of the estimated confidence interval around the point estimate."|Each arm will be assessed individually against a historical control with a single proportion test. The test is designed to reject a PFS rate at 18 months of 40% (null hypothesis) at the 0.08 significance level. Under the alternative hypothesis of a PFS rate at 18 months of 60%, 49 patients are required to reach a power of 84%.||75.9|56.4|
91521337|NCT01422408|182917274|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
91589241|NCT02856893|183068076|OTHER|The decision rule is based on confidence intervals. The treatment strategy will be considered feasible (H0 is rejected) if the lower bound of the 84% two-sided confidence interval of the PFS rate at 18 months is greater than 40%.|Kaplan-Meier survival rate|53.5|||||TWO_SIDED|84.0|42.3|63.5|||||"The population parameter is PFS Rate at 18 months in the Gefitinib till progression than Osimertinib arm. The decision rule is based on the lower bound of the estimated confidence interval around the point estimate."|Each arm will be assessed individually against a historical control with a single proportion test. The test is designed to reject a PFS rate at 18 months of 40% (null hypothesis) at the 0.08 significance level. Under the alternative hypothesis of a PFS rate at 18 months of 60%, 49 patients are required to reach a power of 84%.||63.5|42.3|
91589242|NCT03258554|183068094|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.8878|TWO_SIDED|95.0|0.84|2.12||One-sided significance level = 0.2|Log Rank||Reference arm = radiation therapy + cetuximab|Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.||2.12|0.84|0.8878
91589243|NCT03258554|183068095|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.8175|TWO_SIDED|95.0|0.74|2.28||One-side significance level = 0.025|Log Rank|||||2.28|0.74|0.8175
91589244|NCT03258554|183068096|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.1001|TWO_SIDED|95.0|0.89|3.28||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||3.28|0.89|0.1001
91648060|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.938|TWO_SIDED|95.0|-1.12|1.21|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.21|-1.12|0.938
91589245|NCT03258554|183068097|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.5197|TWO_SIDED|95.0|0.32|1.77||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||1.77|0.32|0.5197
91589246|NCT03258554|183068098|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.3201|TWO_SIDED|95.0|0.57|5.38||Two-sided significance level = 0.05|Log Rank|||||5.38|0.57|0.3201
91589247|NCT03258554|183068099|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
91589248|NCT03258554|183068100|SUPERIORITY|||||||0.0688||||||Two-side significance level = 0.05|Fisher Exact|||||||0.0688
91709094|NCT03035916|183311327|OTHER|||||||0.53|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.530
91781758|NCT02919995|183442923|OTHER||Contrast ratio|0.984||||0.4306|TWO_SIDED|95.0|0.942|1.027|||ANCOVA|||||1.027|0.942|0.4306
91781759|NCT02919995|183442924|OTHER||Contrast ratio|1.065||||0.0064|TWO_SIDED|95.0|1.021|1.11|||ANCOVA|||||1.11|1.021|0.0064
91781760|NCT02919995|183442924|OTHER||Contrast ratio|1.049||||0.0149|TWO_SIDED|95.0|1.011|1.089|||ANCOVA|||||1.089|1.011|0.0149
91589249|NCT03258554|183068103|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.62|1.97|||||Reference arm = RT + Cetuximab|CPS ≥ 1||1.97|0.62|
91589250|NCT03258554|183068103|SUPERIORITY||Cox Proportional Hazard|1.64|||||TWO_SIDED|95.0|0.66|4.06|||||Reference arm = RT + Cetuximab|CPS = 0||4.06|0.66|
91589251|NCT03258554|183068103|SUPERIORITY|||||||0.41||||||Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)|Regression, Cox|||Interaction||||0.41
91589252|NCT03258554|183068104|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.57|2.51|||||Reference arm = RT + cetuximab|p16-positive||2.51|0.57|
91589253|NCT03258554|183068104|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.83|2.89|||||Reference arm = RT + cetuximab|p16-negative||2.89|0.83|
91589254|NCT03258554|183068104|SUPERIORITY|||||||0.61||||||Testing the interaction of treatment arm and p16 status (positive, negative)|Regression, Cox|||Interaction||||0.61
91781761|NCT02919995|183442924|OTHER||Contrast ratio|0.945||||0.466|TWO_SIDED|95.0|0.945|1.027|||ANCOVA|||||1.027|0.945|0.466
91781762|NCT02919995|183442925|OTHER||Contrast ratio|1.061||||0.0093|TWO_SIDED|95.0|1.017|1.107|||ANCOVA|||||1.107|1.017|0.0093
91781763|NCT02919995|183442925|OTHER||Contrast ratio|1.042||||0.0333|TWO_SIDED|95.0|1.004|1.082|||ANCOVA|||||1.082|1.004|0.0333
91781764|NCT02919995|183442925|OTHER||Contrast ratio|0.982||||0.3693|TWO_SIDED|95.0|0.941|1.024|||ANCOVA|||||1.024|0.941|0.3693
91781765|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|2.27|||||TWO_SIDED|95.0|-3.96|8.49||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.49|-3.96|
91781766|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|0.198|||||TWO_SIDED|95.0|-3.19|3.59||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-3.19|
91781767|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|1.55|||||TWO_SIDED|95.0|-2.25|5.35||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.35|-2.25|
91781768|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|20.0|||||TWO_SIDED|95.0|13.7|26.2||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||26.2|13.7|
91781769|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||||TWO_SIDED|95.0|2.8|9.58||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.58|2.80|
91589255|NCT01214187|183068108|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.81||0.2072|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference = (Change from baseline to Week 12 for Carbon monoxide group) minus (Change from baseline to Week 12 for Placebo group)|||||0.2072
91589256|NCT01214187|183068109|SUPERIORITY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.57||0.5882|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|Difference = (Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.5882
91589257|NCT01214187|183068110|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|1.93||0.7401|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|difference=(change from baseline to week 12 for CO group) minus (change from baseline to week 12 for placebo group)|||||0.7401
91589258|NCT01214187|183068111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.46|STANDARD_ERROR_OF_MEAN|18.14||0.0099|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference=(Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.0099
91589259|NCT01214187|183068112|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|2.42||0.8124|TWO_SIDED||||||ANOVA|Repeated measure ANOVA||||||0.8124
91589260|NCT00998426|183068117|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||This is the p value for the meter by time interaction|Random intercept model|||A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.||||0.59
91589261|NCT02308007|183068119|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||||||0.030
91648061|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.753|TWO_SIDED|95.0|-1.43|1.04|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.04|-1.43|0.753
91589262|NCT02308007|183068119|SUPERIORITY|||||||0.073|||||||Chi-squared, Corrected|||||||0.073
91589263|NCT02308007|183068119|SUPERIORITY|||||||0.0204|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0204
91589264|NCT02308007|183068119|SUPERIORITY|||||||0.0493|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0493
91589265|NCT02308007|183068120|SUPERIORITY|||||||0.015|||||||Chi-squared, Corrected|||||||0.015
91648062|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.809|TWO_SIDED|95.0|-1.04|1.33|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.33|-1.04|0.809
91709095|NCT03035916|183311327|OTHER|||||||0.819|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.819
91589266|NCT02308007|183068120|SUPERIORITY|||||||0.193|||||||Chi-squared, Corrected|||Difference for Terconazole/metronidazole vaginal gel cures minus metronidazole vaginal gel cures||||0.193
91589267|NCT02308007|183068121|SUPERIORITY|||||||0.012|||||||Chi-squared, Corrected|||||||0.012
91589268|NCT02308007|183068121|SUPERIORITY|||||||0.918|||||||Chi-squared, Corrected|||||||0.918
91589269|NCT01233869|183068129|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.86|||<|0.0001|TWO_SIDED|95.0|2.02|5.74|||Mixed Models Analysis|||Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.||5.74|2.02|<0.0001
91589270|NCT01233869|183068129|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.83||||0.1234|TWO_SIDED|95.0|-0.5|4.22|||Mixed Models Analysis|||Statistical Analysis 2 is comparison of annualized rate of kidney enlargement: bosutinib 200 mg/day versus bosutinib 400/200 mg/day.||4.22|-0.50|0.1234
91589271|NCT01233869|183068129|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.06||||0.005|TWO_SIDED|95.0|0.93|5.23|||Mixed Models Analysis|||Statistical Analysis 3 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 200 mg/day.||5.23|0.93|0.0050
91589272|NCT01233869|183068129|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.41||||0.1336|TWO_SIDED|95.0|-1.03|8.05|||Mixed Models Analysis|||Statistical Analysis 4 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400 mg/day.||8.05|-1.03|0.1336
91589273|NCT01233869|183068129|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.95|||<|0.0001|TWO_SIDED|95.0|2.65|7.3|||Mixed Models Analysis|||Statistical Analysis 5 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400/200 mg/day.||7.30|2.65|<0.0001
91589274|NCT01324323|183068151|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean (%)|179.3|||||TWO_SIDED|90.0|160.3|200.7|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||200.7|160.3|
91589275|NCT01324323|183068152|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|178.3|||||TWO_SIDED|90.0|159.4|199.4|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||199.4|159.4|
91648063|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.421|TWO_SIDED|95.0|-1.8|0.75|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.75|-1.80|0.421
91589276|NCT01324323|183068153|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|179.6|||||TWO_SIDED|90.0|160.5|201.0|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||201.0|160.5|
91589277|NCT01324323|183068154|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|159.1|||||TWO_SIDED|90.0|135.8|186.5|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||186.5|135.8|
91589278|NCT01324323|183068155|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.15||||0.791|TWO_SIDED|90.0|-1.0|1.01|||Wilcoxon signed-rank|||"Note: The median, median difference (romidepsin + rifampin minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||1.01|-1.0|0.7910
91589279|NCT00537485|183068160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-3.7|1.1|||t-test, 2 sided|||||1.1|-3.7|0.002
91589280|NCT00537485|183068161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.7|||<|0.001|TWO_SIDED|95.0|16.7|44.6|||Chi-squared, Corrected|||||44.6|16.7|<0.001
91589281|NCT00537485|183068161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.001|TWO_SIDED|95.0|12.0|40.2|||Chi-squared, Corrected|||||40.2|12.0|<0.001
91589282|NCT02967354|183068170|SUPERIORITY|||||||0.5875||||||Treshold for significance P\<0.05|ANOVA|||||||0.5875
91589283|NCT02967354|183068171|SUPERIORITY|||||||0.0065||||||Treshold for significance P\<0.05|ANOVA|||||||0.0065
91589284|NCT02967354|183068172|SUPERIORITY|||||||0.0072||||||Treshold for significance P\<0.05|ANOVA|||||||0.0072
91589285|NCT02967354|183068173|SUPERIORITY|||||||0.9472||||||Treshold for significance P\<0.05|ANOVA|||||||0.9472
91648064|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.535|TWO_SIDED|95.0|-0.85|1.63|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.63|-0.85|0.535
91709096|NCT03035916|183311327|OTHER|||||||0.108|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.108
91589286|NCT02967354|183068174|SUPERIORITY|||||||0.0048||||||Treshold for significance P\<0.05|ANOVA|||||||0.0048
91589287|NCT01158651|183068175|SUPERIORITY|The treatment regimen was considered promising for further study if after 48 weeks of treatment there was at least a 25% response rate compared to an expected response rate of 5% or less, which was considered evidence of an unpromising regimen. Assuming the true response rate is 5%, the binomial distribution was used to calculate Type I errors and power.|Proportion responding|0.682|||<|0.001|TWO_SIDED|95.0|0.4872|0.8764|||Exact test|||||0.8764|0.4872|<0.001
91589288|NCT01191541|183068177|NON_INFERIORITY|The primary objective was to demonstrate the noninferiority of DNR alone to DNR+ARA-C in the rate of DFS at 2 years. Assuming a 95% rate of DFS in the two groups, a margin of -15% , 5% type 1 error, 80% power, 30 evaluable patients per group were required to draw a noninferiority conclusion.|||||<|0.05||||||the p-value is not adjusted|Log Rank|||The characteristics of all of the included patients were summarized using cross-tabulations (for categorical variables) and quantiles. Nonparametric tests were used to analyse comparisons between groups .EFS、disease-free survival (DFS) and OS were estimated using the Kaplan -Meier method, and log-rank tests were used. All P values were two-sided, and those with values of 0.05 or less were considered to be statistically significant.||||<0.05
91589289|NCT01601847|183068180|SUPERIORITY||Risk Ratio (RR)|0.66||||0.02|TWO_SIDED|95.0|0.47|0.94|||Poisson|Poisson regression using GEE with robust variance estimation (e.g. Zou, American Journal Epidemiology, 2004)||||0.94|0.47|0.02
91589290|NCT01601847|183068180|SUPERIORITY||Odds Ratio (OR)|0.522||||0.0185|TWO_SIDED|95.0|0.304|0.897|||logistic regression with GEE|||||0.897|0.304|0.0185
91589291|NCT01601847|183068181|SUPERIORITY|||||||0.228|||||||Regression, Logistic|||For secondary outcomes, GEE is used to assess randomization arm association.||||0.228
91589292|NCT01601847|183068182|SUPERIORITY|||||||0.798|||||||Regression, Logistic|||||||0.798
91589293|NCT01603082|183068262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.1|STANDARD_ERROR_OF_MEAN|17.9|<|0.001|TWO_SIDED|95.0|-194.7|-123.5|||t-test, 2 sided||Ticagrelor minus clopidogrel.|||-123.5|-194.7|<0.001
91589294|NCT01603082|183068263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|15.2||0.182|TWO_SIDED|95.0|-50.5|9.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 0.5 hours after the loading dose||9.7|-50.5|0.182
91589295|NCT01603082|183068263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-158.5|STANDARD_ERROR_OF_MEAN|15.5|<|0.001|TWO_SIDED|95.0|-189.4|-127.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 8 hours after the loading dose.||-127.7|-189.4|<0.001
91781770|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|11.7|||||TWO_SIDED|95.0|7.87|15.5||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||15.5|7.87|
91589296|NCT01603082|183068263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|STANDARD_ERROR_OF_MEAN|16.5||0.01|TWO_SIDED|95.0|-76.5|-10.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at end of PCI.||-10.7|-76.5|0.010
91589297|NCT00846885|183068264|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
91589298|NCT00846885|183068265|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|106.0||||||90.0|102.0|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|102|
91589299|NCT00846885|183068266|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|101.0|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|101|
91589300|NCT04561765|183068327|SUPERIORITY|||||||0.051|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.051
91589301|NCT04561765|183068327|SUPERIORITY|||||||0.206|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.206
91589302|NCT04561765|183068327|SUPERIORITY|||||||0.765|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.765
91589303|NCT04561765|183068327|SUPERIORITY|||||||0.991|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at follow-up.||||0.991
91589304|NCT04561765|183068327|SUPERIORITY|||||||0.963|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.963
91709097|NCT03035916|183311327|OTHER|||||||0.667|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.667
91781771|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-13.9|||||TWO_SIDED|95.0|-18.9|-8.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-8.80|-18.9|
91781772|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-4.62|||||TWO_SIDED|95.0|-7.67|-1.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.56|-7.67|
91781773|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-8.43|||||TWO_SIDED|95.0|-11.5|-5.33||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.33|-11.5|
91781774|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|7.8|||||TWO_SIDED|95.0|2.72|12.9||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.9|2.72|
91781775|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|4.38|||||TWO_SIDED|95.0|1.3|7.46||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.46|1.30|
91781776|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|5.06|||||TWO_SIDED|95.0|1.93|8.18||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.18|1.93|
91781777|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|0.905|||||TWO_SIDED|95.0|-5.49|7.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.30|-5.49|
91589305|NCT04561765|183068327|SUPERIORITY|||||||0.916|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.916
91589306|NCT04561765|183068328|SUPERIORITY|||||||0.005|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.005
91589307|NCT04561765|183068328|SUPERIORITY|||||||0.27|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.270
91589308|NCT04561765|183068328|SUPERIORITY|||||||0.177|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.177
91589309|NCT04561765|183068328|SUPERIORITY|||||||0.3|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P Value at follow-up.||||0.300
91589310|NCT04561765|183068328|SUPERIORITY|||||||0.996|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.996
91589311|NCT04561765|183068328|SUPERIORITY|||||||0.334|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.334
91589312|NCT04561765|183068330|SUPERIORITY|||||||0.212|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.212
91589313|NCT04561765|183068330|SUPERIORITY|||||||0.965|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.965
91589314|NCT04561765|183068330|SUPERIORITY|||||||0.294|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.294
91589315|NCT04561765|183068330|SUPERIORITY|||||||0.207|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.207
91589316|NCT04561765|183068330|SUPERIORITY|||||||0.158|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.158
91589317|NCT04561765|183068330|SUPERIORITY|||||||0.988|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.988
91589318|NCT04561765|183068332|SUPERIORITY|||||||0.295|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.295
91589319|NCT04561765|183068332|SUPERIORITY|||||||0.718|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.718
91589320|NCT04561765|183068332|SUPERIORITY|||||||0.738|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.738
91589321|NCT04561765|183068332|SUPERIORITY|||||||0.797|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.797
91648065|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.445|TWO_SIDED|95.0|-0.82|1.86|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.86|-0.82|0.445
91648066|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.309|TWO_SIDED|95.0|-0.67|2.12|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.12|-0.67|0.309
91589322|NCT04561765|183068332|SUPERIORITY|||||||0.26|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.260
91589323|NCT04561765|183068332|SUPERIORITY|||||||0.616|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.616
91589324|NCT04561765|183068333|SUPERIORITY|||||||0.333|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.333
91589325|NCT04561765|183068333|SUPERIORITY|||||||0.003|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.003
91589326|NCT04561765|183068333|SUPERIORITY|||||||0.106|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.106
91589327|NCT04561765|183068333|SUPERIORITY|||||||0.541|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.541
91589328|NCT04561765|183068333|SUPERIORITY|||||||0.202|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.202
91589329|NCT04561765|183068333|SUPERIORITY|||||||0.791|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.791
91589330|NCT04561765|183068334|SUPERIORITY|||||||0.026|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.026
91589331|NCT04561765|183068334|SUPERIORITY|||||||0.15|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.15
91589332|NCT04561765|183068334|SUPERIORITY|||||||0.745|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.745
91589333|NCT04561765|183068334|SUPERIORITY|||||||0.021|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.021
91589334|NCT04561765|183068334|SUPERIORITY|||||||0.155|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.155
91589335|NCT04561765|183068334|SUPERIORITY|||||||0.652|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.652
91589336|NCT04561765|183068335|SUPERIORITY|||||||0.343|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.343
91589337|NCT04561765|183068335|SUPERIORITY|||||||0.995|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.995
91589338|NCT04561765|183068335|SUPERIORITY|||||||0.371|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.371
91589339|NCT04561765|183068335|SUPERIORITY|||||||0.228|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.228
91589340|NCT04561765|183068335|SUPERIORITY|||||||0.282|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.282
91589341|NCT04561765|183068335|SUPERIORITY|||||||0.986|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.986
91589342|NCT04561765|183068336|SUPERIORITY|||||||0.421|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.421
91589343|NCT04561765|183068336|SUPERIORITY|||||||0.556|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.556
91589344|NCT02645760|183068467|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.26 points in mean 11-point NRS pain score between core stabilization exercise and conventional treatment from baseline to week 7.||||<0.001
91589345|NCT02645760|183068468|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.68 points in mean disability score (RMDQ score) between core stabilization exercise and conventional treatment from baseline to week 7.||||0.009
91589346|NCT02645760|183068469|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.79 centimeter in mean range of motion between core stabilization exercise and conventional treatment from baseline to week 7.||||0.013
91589347|NCT02645760|183068470|SUPERIORITY_OR_OTHER|||||||0.012|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.30 centimeter in mean repositioning error between core stabilization exercise and conventional treatment from baseline to week 7.||||0.012
91589348|NCT01284062|183068471|SUPERIORITY_OR_OTHER||Least squares (LS) mean|0.41|||||TWO_SIDED|80.0|0.225|0.766|||||LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.|||0.766|0.225|
91589349|NCT01284062|183068471|SUPERIORITY_OR_OTHER||LS mean|0.29|||||TWO_SIDED|80.0|0.187|0.446|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||0.446|0.187|
91589350|NCT01284062|183068471|SUPERIORITY_OR_OTHER||LS mean|0.79|||||TWO_SIDED|80.0|0.517|1.203|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.203|0.517|
91589351|NCT01284062|183068471|SUPERIORITY_OR_OTHER||LS mean|1.24|||||TWO_SIDED|80.0|0.794|1.949|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.949|0.794|
91589352|NCT01284062|183068471|SUPERIORITY_OR_OTHER||LS mean ratio|0.7||||0.532|TWO_SIDED|80.0|0.329|1.472|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.472|0.329|0.5320
91589353|NCT01284062|183068471|SUPERIORITY_OR_OTHER||LS mean ratio|1.9||||0.27|TWO_SIDED|80.0|0.9|4.013|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||4.013|0.900|0.2700
91589354|NCT01284062|183068471|SUPERIORITY_OR_OTHER||LS mean ratio|3.0||||0.0666|TWO_SIDED|80.0|1.403|6.409|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||6.409|1.403|0.0666
91648067|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.872|TWO_SIDED|95.0|-1.34|1.57|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-1.34|0.872
91648068|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.004|TWO_SIDED|95.0|0.79|4.26|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.26|0.79|0.004
91648069|NCT00996918|183188599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.026|TWO_SIDED|95.0|0.25|3.93|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|0.25|0.026
91648070|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.504|TWO_SIDED|95.0|-0.77|1.57|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-0.77|0.504
91648071|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.592|TWO_SIDED|95.0|-1.58|0.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.90|-1.58|0.592
91648072|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.441|TWO_SIDED|95.0|-0.72|1.65|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.65|-0.72|0.441
91648073|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.288|TWO_SIDED|95.0|-1.97|0.59|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.59|-1.97|0.288
91648074|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.303|TWO_SIDED|95.0|-0.59|1.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.90|-0.59|0.303
91648075|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.713|TWO_SIDED|95.0|-1.09|1.6|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.60|-1.09|0.713
91648076|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.198|TWO_SIDED|95.0|-0.49|2.34|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.34|-0.49|0.198
91648077|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.756|TWO_SIDED|95.0|-1.7|1.24|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.24|-1.70|0.756
91521338|NCT01422408|182917275|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
91589355|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.7|||||TWO_SIDED|80.0|0.466|1.048||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.048|0.466|
91589356|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.81|||||TWO_SIDED|80.0|0.552|1.185||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.185|0.552|
91589357|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.71|||||TWO_SIDED|80.0|0.488|1.027||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.027|0.488|
91589358|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.77|||||TWO_SIDED|80.0|0.5|1.195||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.195|0.500|
91521339|NCT01422408|182917276|OTHER|||||||0.08531||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.08531
91521340|NCT01422408|182917277|OTHER|||||||0.2011||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2011
91521341|NCT01422408|182917278|OTHER|||||||0.1187||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1187
91521342|NCT02038894|182917286|NON_INFERIORITY|A previous study for evaluating respiratory complications with intubated and insufflated techniques found a difference in the incidence of respiratory complications of 9.1%, a power analysis was determined. 200 subjects per group was estimated provide 82% power to detect a difference. We elected to do an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications.|Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.14||Threshold for significance \<0.05 Comparing SPO2 \<95%|Mean equality test|||||0.14|0|<0.0001
91521343|NCT02038894|182917286|NON_INFERIORITY|A previous study found an incidence of respiratory complications of 9.1%. 200 subjects per group was estimated provide 82% power to detect a difference when conducting a two- sided test at a significance level of a = 0.05.We did an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications. Based on the results of that interim analysis, recruitment was discontinued|Odds Ratio (OR)|0.0||||0.0001|TWO_SIDED|95.0|0.0|0.27||p\<0.05. Sp02\<85%|Mean equality test||Odds ratios were calculated to the respiratory complications comparing the different groups and by regrouping by the differences in airway management (IS + IP vs NA) and by the medication used for anesthesia maintenance (IS vs IP + NA)|||0.27|0|0.0001
91521344|NCT02038894|182917287|NON_INFERIORITY|No previous data was available to calculate a power calculation for the secondary outcome.||||||0.901||||||Threshold of Significance|Mean equality test|||Total OR Time||||0.901
91521345|NCT00724152|182917288|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.||||<0.05
91589359|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.631|1.328||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.328|0.631|
91589360|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.47|||||TWO_SIDED|80.0|0.339|0.655||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.655|0.339|
91589361|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.669|1.269||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.269|0.669|
91521346|NCT03266770|182917299|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.83|TWO_SIDED|95.0|-1.07|1.29|||t-test, 2 sided|||||1.29|-1.07|0.83
91521347|NCT04274894|182917301|NON_INFERIORITY|"The hypothesis for the primary safety analysis is:~H0: Change in 24-hour average SBP from Baseline to EOT ≥ 3 mmHg Vs. H1: Change in 24-hour average SBP from Baseline to EOT \< 3 mmHg"|LS Mean Change from Baseline to EOT|1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|0.63|3.13||||||The primary endpoint of change from Baseline to End of Treatment (EOT) in average 24-hour SBP was evaluated using a linear regression model with change in average 24-hour SBP from Baseline to EOT as the dependent variable, centralized baseline average 24-hour SBP, ongoing medical history of hypertension, and pooled study center as covariates in the per protocol population.||3.13|0.63|
91521348|NCT03848403|182917307|SUPERIORITY||Least Squares (LS) Means Difference|-21.69|||<|0.0001|TWO_SIDED|95.0|-26.9|-16.48|||Mixed Models Analysis|||||-16.48|-26.90|<0.0001
91521349|NCT03848403|182917307|SUPERIORITY||LS Means Difference|-21.14|||<|0.0001|TWO_SIDED|95.0|-26.39|-15.88|||Mixed Models Analysis|||||-15.88|-26.39|<0.0001
91521350|NCT03848403|182917307|SUPERIORITY||LS Means Difference|0.55||||0.8341|TWO_SIDED|95.0|-4.65|5.75|||Mixed Models Analysis|||||5.75|-4.65|0.8341
91521351|NCT00101933|182917327|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Since a treatment-by-visit interaction remains in the final model, the results were analyzed by visit. The results shown are for the last month in the blinded phase (month 3-4).|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0017
91521352|NCT00101933|182917329|SUPERIORITY_OR_OTHER||Rate per 1000 years of stimulation|4.9|||||TWO_SIDED|95.0|0.6|17.79|||No statistical test||The rate is calculated per 1000 subject years of follow-up based on 406 subject years of stimulation. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP were included in the calculation.|||17.79|0.60|
91521353|NCT00101933|182917330|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Fisher Exact|||Fisher's Exact test. The numbers presented in this analysis are the number of subjects who were responders based on a responder definition including all subjects with 50% or greater improvement in total seizure count.||||0.830
91521354|NCT00101933|182917331|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.105
91521355|NCT00101933|182917332|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.498
91521356|NCT00101933|182917333|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91521357|NCT00101933|182917334|SUPERIORITY_OR_OTHER|||||||0.0387||95.0||||Since a visit-by-treatment interaction did not remain in the final model, the results shown are for the entire blinded phase.|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0387
91521358|NCT00101933|182917335|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||Numbers provided indicate the percentage change from baseline in seizure frequency of each participant's most severe seizures. Negative values indicate improvement from baseline.||||0.047
91521359|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.517|TWO_SIDED|95.0|-10.4|5.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4.||5.2|-10.4|0.517
91521360|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.763|TWO_SIDED|95.0|-8.9|6.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||6.5|-8.9|0.763
91521361|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.164|TWO_SIDED|95.0|-2.3|13.3|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||13.3|-2.3|0.164
91521362|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.9|TWO_SIDED|95.0|-9.2|10.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||10.5|-9.2|0.900
91521363|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.788|TWO_SIDED|95.0|-11.1|8.4|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||8.4|-11.1|0.788
91521364|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.722|TWO_SIDED|95.0|-8.2|11.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||11.8|-8.2|0.722
91521365|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7||||0.26|TWO_SIDED|95.0|-18.2|4.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||4.9|-18.2|0.260
91589362|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.55|||||TWO_SIDED|80.0|0.388|0.779||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.779|0.388|
91589363|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.78|||||TWO_SIDED|80.0|0.454|1.331||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.331|0.454|
91589364|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.36|||||TWO_SIDED|80.0|0.236|0.553||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.553|0.236|
91589365|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|1.14|||||TWO_SIDED|80.0|0.757|1.722||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.722|0.757|
91589366|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.52|||||TWO_SIDED|80.0|0.338|0.788||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.788|0.338|
91589367|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.64|||||TWO_SIDED|80.0|0.374|1.084||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.084|0.374|
91589368|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.19|||||TWO_SIDED|80.0|0.122|0.297||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.297|0.122|
91648078|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.006|TWO_SIDED|95.0|0.69|4.22|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.22|0.69|0.006
91648079|NCT00996918|183188600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.066|TWO_SIDED|95.0|-0.12|3.62|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.62|-0.12|0.066
91648080|NCT01965535|183188602|SUPERIORITY_OR_OTHER||difference in proportions|1.4|||||TWO_SIDED|95.0|-5.9|8.6|||||The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.|A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.||8.6|-5.9|
91781778|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-2.71|||||TWO_SIDED|95.0|-6.96|1.54||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.54|-6.96|
91781779|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|1.66|||||TWO_SIDED|95.0|-2.85|6.16||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.16|-2.85|
91589369|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.96|||||TWO_SIDED|80.0|0.623|1.465||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.465|0.623|
91589370|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean|0.67|||||TWO_SIDED|80.0|0.411|1.076||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.076|0.411|
91589371|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.16||||0.7352|TWO_SIDED|80.0|0.663|2.021|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.021|0.663|0.7352
91589372|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9754|TWO_SIDED|80.0|0.586|1.753|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.753|0.586|0.9754
91589373|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.11||||0.8277|TWO_SIDED|80.0|0.609|2.008|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.008|0.609|0.8277
91589374|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|0.51||||0.0885|TWO_SIDED|80.0|0.313|0.846|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.846|0.313|0.0885
91589375|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9856|TWO_SIDED|80.0|0.617|1.644|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.644|0.617|0.9856
91589376|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|0.6||||0.1996|TWO_SIDED|80.0|0.361|1.0|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.000|0.361|0.1996
91589377|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|0.46||||0.1553|TWO_SIDED|80.0|0.233|0.926|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.926|0.233|0.1553
91589378|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.47||||0.4633|TWO_SIDED|80.0|0.748|2.882|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.882|0.748|0.4633
91781780|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|17.5|||||TWO_SIDED|95.0|11.2|23.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||23.8|11.2|
91781781|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|6.51|||||TWO_SIDED|95.0|2.32|10.7||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||10.7|2.32|
91781782|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|14.2|||||TWO_SIDED|95.0|9.75|18.7||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.7|9.75|
91589379|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|0.66||||0.4409|TWO_SIDED|80.0|0.335|1.316|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.316|0.335|0.4409
91781783|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|||||TWO_SIDED|95.0|-14.6|-5.34||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.34|-14.6|
91781784|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-3.46|||||TWO_SIDED|95.0|-7.22|0.297||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.297|-7.22|
91589380|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|0.3||||0.0283|TWO_SIDED|80.0|0.15|0.598|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.598|0.150|0.0283
91589381|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.5||||0.4434|TWO_SIDED|80.0|0.758|2.97|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.970|0.758|0.4434
91589382|NCT01284062|183068478|SUPERIORITY_OR_OTHER||LS mean ratio|1.04||||0.9372|TWO_SIDED|80.0|0.51|2.141|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.141|0.510|0.9372
91589383|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percentage of participants|41.67|||||TWO_SIDED|80.0|25.53|59.81|||||CI was assessed by Wilson score method.|||59.81|25.53|
91589384|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percentage of participants|60.0|||||TWO_SIDED|80.0|43.59|74.43|||||CI was assessed by Wilson score method.|||74.43|43.59|
91589385|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|80.0|34.74|65.26|||||CI was assessed by Wilson score method.|||65.26|34.74|
91589386|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percentage of participants|15.38|||||TWO_SIDED|80.0|6.58|31.96|||||CI was assessed by Wilson score method.|||31.96|6.58|
91589387|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percent difference|18.33||||0.4495|TWO_SIDED|80.0|-6.13|39.98|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||39.98|-6.13|0.4495
91589388|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percent difference|8.33||||0.7177|TWO_SIDED|80.0|-15.37|30.54|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||30.54|-15.37|0.7177
91589389|NCT01284062|183068483|SUPERIORITY_OR_OTHER||percent difference|-26.28||||0.2016|TWO_SIDED|80.0|-46.45|-3.15|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-3.15|-46.45|0.2016
91589390|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percentage of participants|16.67|||||TWO_SIDED|80.0|7.14|34.22|||||CI was assessed by Wilson score method.|||34.22|7.14|
91589391|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percentage of participants|33.33|||||TWO_SIDED|80.0|20.08|49.88|||||CI was assessed by Wilson score method.|||49.88|20.08|
91589392|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percentage of participants|18.75|||||TWO_SIDED|80.0|9.4|33.92|||||CI was assessed by Wilson score method.|||33.92|9.40|
91589393|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|80.0|0.0|11.22|||||CI was assessed by Wilson score method.|||11.22|0.00|
91589394|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percent difference|16.67||||0.4082|TWO_SIDED|80.0|-5.33|35.76|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||35.76|-5.33|0.4082
91589395|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percent difference|2.08||||1|TWO_SIDED|80.0|-17.8|19.99|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||19.99|-17.80|1.0000
91589396|NCT01284062|183068484|SUPERIORITY_OR_OTHER||percent difference|-16.67||||0.22|TWO_SIDED|80.0|-34.22|-1.95|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-1.95|-34.22|0.2200
91589397|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean|-1.32|||||TWO_SIDED|80.0|-2.332|-0.3||||||||-0.300|-2.332|
91589398|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean|-2.28|||||TWO_SIDED|80.0|-3.19|-1.374||||||||-1.374|-3.190|
91589399|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean|-2.3|||||TWO_SIDED|80.0|-3.178|-1.419||||||||-1.419|-3.178|
91589400|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean|-0.79|||||TWO_SIDED|80.0|-1.761|0.19||||||||0.190|-1.761|
91589401|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean difference|-0.97||||0.3639|TWO_SIDED|80.0|-2.335|0.403|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.403|-2.335|0.3639
91589402|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean difference|-0.98||||0.3446|TWO_SIDED|80.0|-2.32|0.355|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.355|-2.320|0.3446
91781785|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-8.16|||||TWO_SIDED|95.0|-11.6|-4.71||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.71|-11.6|
91781786|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|12.1|||||TWO_SIDED|95.0|7.39|16.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|7.39|
91781787|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|6.7|||||TWO_SIDED|95.0|2.91|10.5||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.5|2.91|
91781788|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|10.3|||||TWO_SIDED|95.0|6.88|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|6.88|
91648081|NCT01946282|183188632|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.59|||||||Chi-squared|||||||0.59
91648082|NCT01946282|183188632|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.75|||||||Chi-squared|||||||.75
91648083|NCT01946282|183188632|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.08|||||||Chi-squared|||||||.080
91648084|NCT01946282|183188633|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.07|||||||Chi-squared|||||||0.070
91648085|NCT01946282|183188633|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.8|||||||Chi-squared|||||||0.80
91648086|NCT01946282|183188633|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.6|||||||Chi-squared|||||||0.60
91648087|NCT01946282|183188633|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.31|||||||Chi-squared|||||||0.31
91648088|NCT01946282|183188633|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.82|||||||Chi-squared|||||||0.82
91648089|NCT01946282|183188633|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.033|||||||Chi-squared|||||||0.033
91648090|NCT01946282|183188633|EQUIVALENCE|We estimated needing 545 observations per incentive group to achieve power necessary to detect at least a 10% absolute difference in FIT return rate between patients who received the $5 incentive versus patients who received the $10 incentive, with assumed rates of 45% in the $5 incentive group and 53% in the $10 incentive group, a=0.05, and power=90%.||||||0.033|||||||Chi-squared|||||||0.033
91648091|NCT01946282|183188633|EQUIVALENCE||||||>|0.99|||||||Chi-squared|||||||>0.99
91781789|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-1.06|||||TWO_SIDED|95.0|-7.41|5.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.30|-7.41|
91781790|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|2.2|||||TWO_SIDED|95.0|-2.15|6.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.56|-2.15|
91648092|NCT01946282|183188633|EQUIVALENCE|||||||0.184|||||||Chi-squared|||||||0.184
91648093|NCT00078819|183188638|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
91648094|NCT00078819|183188639|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
91709098|NCT03035916|183311327|OTHER|||||||0.046|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.046
91781791|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||||TWO_SIDED|95.0|-3.23|5.47||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.47|-3.23|
91781792|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|19.4|||||TWO_SIDED|95.0|13.2|25.6||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||25.6|13.2|
91781793|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|9.04|||||TWO_SIDED|95.0|4.78|13.3||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||13.3|4.78|
91781794|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|14.7|||||TWO_SIDED|95.0|10.4|18.9||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.9|10.4|
91589403|NCT01284062|183068485|SUPERIORITY_OR_OTHER||LS mean difference|0.53||||0.6285|TWO_SIDED|80.0|-0.884|1.945|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||1.945|-0.884|0.6285
91589404|NCT04722250|183068554|NON_INFERIORITY|The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.|Risk Difference (RD)|-1.2|||<|0.001|TWO_SIDED|90.0|-4.9|2.5|||z-test on Kaplan-Meier percentages|||||2.5|-4.9|<0.001
91589405|NCT04722250|183068555|SUPERIORITY||Risk Difference (RD)|-32.2|||<|0.001|TWO_SIDED|95.0|-38.7|-25.6|||z-test on Kaplan-Meier percentages|||||-25.6|-38.7|<0.001
91589406|NCT03829319|183068601|OTHER||Hazard Ratio (HR)|0.88||||0.07976|TWO_SIDED|95.0|0.74|1.05|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.05|0.74|0.07976
91589407|NCT03829319|183068602|OTHER||Hazard Ratio (HR)|1.05||||0.70818|TWO_SIDED|95.0|0.88|1.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.26|0.88|0.70818
91589408|NCT03829319|183068603|OTHER||Percent Difference|6.3||||0.08643|TWO_SIDED|95.0|-2.8|15.4|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Comparison based on Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50% ).||15.4|-2.8|0.08643
91589409|NCT03829319|183068607|OTHER||Difference in Least Square Means|-1.01||||0.4805|TWO_SIDED|95.0|-3.83|1.8|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||1.80|-3.83|0.4805
91589410|NCT03829319|183068608|OTHER||Difference in Least Square Means|-0.29||||0.8747|TWO_SIDED|95.0|-3.95|3.36|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||3.36|-3.95|0.8747
91648095|NCT00078819|183188640|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
91648096|NCT00078819|183188641|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Van Elteren test|Two-sided van Elteren's test stratified by age group||||||<0.0001
91648097|NCT00078819|183188642|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
91648098|NCT01749033|183188706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Chi-squared|||We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.76
91648099|NCT01749033|183188708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.05|TWO_SIDED||||||Chi-squared||The reported p value was calculated.|We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.05
91648100|NCT01039584|183188742|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-9.1|12.3|||Wald's method|||||12.3|-9.1|
91781795|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|||||TWO_SIDED|95.0|-15.6|-5.52||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.52|-15.6|
91648101|NCT01039584|183188743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-7.3|12.8|||Wald's method|||||12.8|-7.3|
91648102|NCT01039584|183188744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure|Yates continuity correction|1.5||||0.05|TWO_SIDED|90.0|-11.7|9.4|||Wald's method|||||9.4|-11.7|0.05
91781796|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-4.25|||||TWO_SIDED|95.0|-9.26|0.764||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.764|-9.26|
91781797|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|-8.76|||||TWO_SIDED|95.0|-12.6|-4.87||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.87|-12.6|
91781798|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|95.0|7.17|17.4||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||17.4|7.17|
91781799|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|5.95|||||TWO_SIDED|95.0|0.917|11.0||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.0|0.917|
91589411|NCT03829319|183068609|OTHER||Difference in Least Square Means|-0.91||||0.5941|TWO_SIDED|95.0|-4.24|2.43|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (\<50% versus ≥50%)) as covariates.||2.43|-4.24|0.5941
91589412|NCT03829319|183068610|OTHER||covariate|-2.16||||0.3115|TWO_SIDED|95.0|-6.36|2.03|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.03|-6.36|0.3115
91589413|NCT03829319|183068611|OTHER||covariate|-0.37||||0.8134|TWO_SIDED|95.0|-3.47|2.72|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.72|-3.47|0.8134
91589414|NCT03829319|183068612|OTHER||Hazard Ratio (HR)|1.16||||0.2133|TWO_SIDED|95.0|0.92|1.47|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.47|0.92|0.2133
91589415|NCT03829319|183068613|OTHER||Hazard Ratio (HR)|1.41||||0.0377|TWO_SIDED|95.0|1.02|1.94|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.94|1.02|0.0377
91589416|NCT03829319|183068614|OTHER||Hazard Ratio (HR)|0.87||||0.4084|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.21|0.62|0.4084
91589417|NCT03829319|183068615|OTHER||Hazard Ratio (HR)|1.04||||0.7955|TWO_SIDED|95.0|0.79|1.36|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.36|0.79|0.7955
91589418|NCT03829319|183068617|OTHER||Hazard Ratio (HR)|1.04||||0.7191|TWO_SIDED|95.0|0.84|1.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.28|0.84|0.7191
91589419|NCT04484259|183068618|NON_INFERIORITY|non-inferiority margin 45 PRU|Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-23.0|38.0||||||The primary end point was non-inferiority of Ticagrelor 60 mg monotherapy vs. aspirin plus Ticagrelor 60 mg||38|-23|
91589420|NCT04498832|183068622|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was greater than (\>) 1 between groups for each of the comparisons.|GMT ratio|2.81|||||TWO_SIDED|95.0|2.46|3.2|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H1N1||3.20|2.46|
91589421|NCT04498832|183068622|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.25|||||TWO_SIDED|95.0|2.03|2.5|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H3N2-like||2.50|2.03|
91589422|NCT04498832|183068622|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.55|||||TWO_SIDED|95.0|2.31|2.81|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Victoria-like||2.81|2.31|
91589423|NCT04498832|183068622|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|3.12|||||TWO_SIDED|95.0|2.85|3.42|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Yamagata||3.42|2.85|
91589424|NCT04498832|183068623|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|29.7|||||TWO_SIDED|95.0|25.7|33.5|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H1N1||33.5|25.7|
91589425|NCT04498832|183068623|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|28.1|||||TWO_SIDED|95.0|24.0|32.0|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H3N2-like||32.0|24.0|
91589426|NCT04498832|183068623|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|31.4|||||TWO_SIDED|95.0|27.4|35.2|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Victoria-like||35.2|27.4|
91589427|NCT04498832|183068623|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|35.4|||||TWO_SIDED|95.0|31.4|39.3|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Yamagata||39.3|31.4|
91589428|NCT01313650|183068635|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.076|0.155|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.155|0.076|<0.001
91589429|NCT01313650|183068635|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072|||<|0.001|TWO_SIDED|95.0|0.032|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.112|0.032|<0.001
91589430|NCT01313650|183068635|SUPERIORITY_OR_OTHER||Least squares mean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.207|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.207|0.128|<0.001
91589431|NCT01313650|183068635|SUPERIORITY_OR_OTHER||Least squares mean difference|0.052||||0.004|TWO_SIDED|95.0|0.017|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.|||0.087|0.017|0.004
91589432|NCT01313650|183068635|SUPERIORITY_OR_OTHER||Least squares mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.|||0.130|0.060|<0.001
91589433|NCT04029480|183068639|SUPERIORITY||Difference in Bayesian Means|-0.67|||||TWO_SIDED|95.0|-1.06|-0.29||||||This analysis is based on a Bayesian ANCOVA model including terms for Baseline A1C, treatment, age (10 to 14 years/15 to 17 years), and insulin use (yes/no) at Screening and calculated by Rubin's Rule. The 95% confidence interval actually refers to a credible interval.||-0.29|-1.06|
91589434|NCT04029480|183068640|OTHER||Difference in Percent|-6.8|||||TWO_SIDED|95.0|-22.2|9.3||||||This analysis is based on Miettinen \& Nurminen method.||9.3|-22.2|
91589435|NCT04029480|183068641|OTHER||Difference in Percent|-12.4|||||TWO_SIDED|95.0|-25.9|2.8||||||This analysis is based on Miettinen \& Nurminen method.||2.8|-25.9|
91589436|NCT04029480|183068642|OTHER||Difference in Percent|0.0|||||||||||||No confidence intervals (CIs) were calculated. CIs were computed only for those endpoints where at least ≥8 participants in the combined ertugliflozin group or ≥2 participants in the placebo group had events.|This analysis is based on Miettinen \& Nurminen method.||||
91589437|NCT04029480|183068643|OTHER||Difference in Percent|-1.8|||||||||||||No confidence intervals (CIs) were calculated. CIs were computed only for those endpoints where at least ≥8 participants in the combined ertugliflozin group or ≥2 participants in the placebo group had events.|This analysis is based on Miettinen \& Nurminen method.||||
91589438|NCT04029480|183068644|SUPERIORITY||Difference in Least Squares Means|-0.66||||0.021|TWO_SIDED|95.0|-1.23|-0.1|||ANCOVA|||This analysis is based on an ANCOVA model including terms for Baseline A1C, treatment, age (10 to 14 years/15 to 17 years), and insulin use (yes/no) at Screening and calculated by Rubin's Rule.||-0.10|-1.23|0.021
91589439|NCT04029480|183068645|SUPERIORITY||Difference in Least Squares Means|-0.86||||0.001|TWO_SIDED|95.0|-1.39|-0.33|||ANCOVA|||This analysis is based on an ANCOVA model including terms for Baseline A1C, treatment, age (10 to 14 years/15 to 17 years), and insulin use (yes/no) at Screening and calculated by Rubin's Rule.||-0.33|-1.39|0.001
91589440|NCT04029480|183068646|SUPERIORITY||Difference in Least Squares Means|-29.0||||0.001|TWO_SIDED|95.0|-44.4|-13.6|||cLDA|||This analysis is based on a constrained longitudinal data analysis (cLDA) model including terms for treatment, time, age (10 to 14 years/15 to 17 years), insulin use (yes/no), interaction of time by treatment with the constraint that the model estimated a single baseline mean (applicable to all treatment groups).||-13.6|-44.4|0.001
91589441|NCT04029480|183068647|SUPERIORITY||Difference in Least Squares Means|-1.03||||0.003|TWO_SIDED|95.0|-1.7|-0.35|||cLDA|||This analysis is a based on a constrained longitudinal data analysis (cLDA) model including terms for treatment, time, age (10 to 14 years/15 to 17 years), insulin use (yes/no), interaction of time by treatment with the constraint that the model estimated a single baseline mean (applicable to all treatment groups).||-0.35|-1.70|0.003
91589442|NCT04029480|183068648|SUPERIORITY||Difference in Least Squares Means|-33.1||||0.001|TWO_SIDED|95.0|-53.0|-13.1|||cLDA|||This analysis is based on a constrained longitudinal data analysis (cLDA) model including terms for treatment, time, age (10 to 14 years/15 to 17 years), insulin use (yes/no), interaction of time by treatment with the constraint that the model estimated a single baseline mean (applicable to all treatment groups).||-13.1|-53.0|0.001
91589443|NCT01839487|183068671|OTHER||Hazard Ratio (HR)|0.74||||0.058|TWO_SIDED|95.0|0.54|1.01||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the Karnofsky Performance Status (KPS) category (70-80% and 90-100%) at screening using AG as the reference arm.||1.01|0.54|0.058
91589444|NCT01839487|183068673|OTHER||Hazard Ratio (HR)|0.57||||0.092|TWO_SIDED|95.0|0.3|1.1||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-high was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.10|0.30|0.092
91709099|NCT03035916|183311327|OTHER|||||||0.006|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.006
91589445|NCT01839487|183068673|OTHER||Hazard Ratio (HR)|0.88||||0.514|TWO_SIDED|95.0|0.59|1.31||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-low was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.31|0.59|0.514
91589446|NCT01839487|183068674|OTHER||Risk Ratio (RR)|1.22||||0.225|TWO_SIDED|95.0|0.88|1.68||Threshold for significance at 0.1 level.|Cochran-Mantel-Haenszel|||p-Value and relative risk were based on a stratified Cochran-Mantel-Haenszel method using KPS category at screening as the stratification factor.||1.68|0.88|0.225
91589447|NCT01839487|183068675|OTHER||Hazard Ratio (HR)|0.91||||0.495|TWO_SIDED|95.0|0.7|1.19||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.19|0.70|0.495
91589448|NCT03714425|183068689|SUPERIORITY||||||<|0.05||||||The primary research objective to measure perceived improvement in pain at three months was assessed using a two-sample t-test of PGIC scores between the two treatment groups using a type I error rate of 0.05 (two-sided).|t-test, 2 sided|Most of the analyses involved delta scores reflecting changes within subjects, though we compared PGIC raw scores rather than change scores.||||||<0.05
91589449|NCT01658826|183068691|SUPERIORITY||Risk Ratio (RR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||non-linear mixed effects model|||||0.63|0.30|<0.0001
91589450|NCT03877432|183068699|SUPERIORITY|||||||0.012|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 1T stimulation amplitude changes on bladder capacity.||||0.012
91589451|NCT03877432|183068699|SUPERIORITY|||||||0.017|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 2T stimulation amplitude changes on bladder capacity.||||0.017
91589452|NCT03877432|183068699|SUPERIORITY|||||||0.003|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 3T stimulation amplitude changes on bladder capacity.||||0.003
91589453|NCT03877432|183068699|SUPERIORITY|||||||0.004|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 4T stimulation amplitude changes on bladder capacity.||||0.004
91589454|NCT01474863|183068717|SUPERIORITY|||||||0.86|||||||ANOVA|||||||0.86
91589455|NCT02038920|183068718|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1448|TWO_SIDED|95.0|0.816|3.958|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||3.958|0.816|0.1448
91589456|NCT02038920|183068719|SUPERIORITY||Odds Ratio (OR)|3.57||||0.1779|TWO_SIDED|95.0|0.532|23.953|||Pearson's Chi-square Test||MLN0002 group/placebo group|||23.953|0.532|0.1779
91589457|NCT02038920|183068725|SUPERIORITY||Odds Ratio (OR)|1.83||||0.1963|TWO_SIDED|95.0|0.72|4.673|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||4.673|0.720|0.1963
91589458|NCT02038920|183068727|SUPERIORITY||Odds Ratio (OR)|15.4||||0.0094|TWO_SIDED|95.0|1.473|160.972|||Pearson's Chi-square Test|||||160.972|1.473|0.0094
91589459|NCT02038920|183068728|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6534|TWO_SIDED|95.0|0.254|8.844|||Pearson's Chi-square Test||MLN0002 group/placebo group.|||8.844|0.254|0.6534
91648103|NCT03550794|183188755|OTHER||Mean Difference (Final Values)|-0.57||||0.07|TWO_SIDED|95.0|-1.18|0.04||"Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.~Missing creatinine imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.04|-1.18|0.07
91589460|NCT02038920|183068729|SUPERIORITY|||||||0.2059|||||||Pearson's Chi-square Test|||||||0.2059
91589461|NCT00866697|183068738|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.766||||0.0021|TWO_SIDED|95.0|0.643|0.911||The P-value from the stratified log-rank test was adjusted for the two stratification factors.|Log Rank||The Hazard Ratio was estimated using a Pike estimator.|||0.911|0.643|0.0021
91589462|NCT00866697|183068739|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6431|TWO_SIDED|95.0|0.805|1.145|||Log Rank|Stratified Log-Rank P-Value.|"The HR was estimated using a Pike estimator.~CIs were estimated using the Brookmeyer-Crowley method."|||1.145|0.805|0.6431
91589463|NCT01703663|183068765|SUPERIORITY_OR_OTHER||absolute difference|-5.73||||0.183|TWO_SIDED|95.0|-14.4|2.97|||ANOVA|||||2.97|-14.4|0.183
91589464|NCT02113579|183068833|SUPERIORITY_OR_OTHER||Success rate difference (%)|24.7|||<|0.001|TWO_SIDED|||||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05) with estimated difference of \>= 20%, testing proceeded to Mean Cold Air Stimulus VAS Score at Week 4. Family-wise error was controlled at 0.05.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 4, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||<0.001
91589465|NCT02113579|183068834|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.27|STANDARD_ERROR_OF_MEAN|2.239|<|0.001|TWO_SIDED|95.0|-18.68|-9.87||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Tactile Sensitivity Score at Week 4. Family-wise error was controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-9.87|-18.68|<0.001
91648104|NCT03550794|183188756|OTHER||Odds Ratio (OR)|0.58||||0.34|TWO_SIDED|95.0|0.18|1.74||P-value from odds ratio from logistic regression model controlling for site, with outcome of receiving renal replacement therapy.|Regression, Logistic|||||1.74|0.18|0.34
91521366|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.422|TWO_SIDED|95.0|-16.1|6.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||6.8|-16.1|0.422
91589466|NCT02113579|183068835|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.45|STANDARD_ERROR_OF_MEAN|1.844|<|0.001|TWO_SIDED|95.0|9.83|17.08||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Cold Air Stimulus VAS Score at Week 2 and Mean Tactile Sensitivity Score at Week 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||17.08|9.83|<0.001
91648105|NCT03550794|183188757|OTHER||Median Difference (Final Values)|22.0||||0.002|TWO_SIDED|95.0|7.4|36.6||P-value from quantile regression model controlling for site.|Quantile regression|||||36.6|7.4|0.002
91648106|NCT03550794|183188758|OTHER||Hazard Ratio (HR)|0.62||||0.14|TWO_SIDED|95.0|0.32|1.18||P-value from Cox proportional hazards model adjusting for site.|Regression, Cox|||||1.18|0.32|0.14
91781800|NCT01263197|183442972|SUPERIORITY_OR_OTHER||LS mean difference|9.9|||||TWO_SIDED|95.0|5.98|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|5.98|
91521367|NCT01218126|182917371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.564|TWO_SIDED|95.0|-15.1|8.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||8.2|-15.1|0.564
91521368|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.968|TWO_SIDED|95.0|-39.0|38.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 4||38|-39|0.968
91521369|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.715|TWO_SIDED|95.0|-45.0|31.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 Placebo versus Losmapimod 7.5 mg at Week 4||31|-45|0.715
91521370|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.152|TWO_SIDED|95.0|-10.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||66|-10|0.152
91521371|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.922|TWO_SIDED|95.0|-45.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||40|-45|0.922
91521372|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.694|TWO_SIDED|95.0|-34.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-34|0.694
91521373|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.0||||0.094|TWO_SIDED|95.0|-6.3|79.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||79|-6.3|0.094
91521374|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.456|TWO_SIDED|95.0|-26.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||58|-26|0.456
91521375|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-22.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||61|-22|0.355
91521376|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.023|TWO_SIDED|95.0|6.7|91.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||91|6.7|0.023
91781801|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|1.62|||||TWO_SIDED|95.0|-1.81|5.06||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.06|-1.81|
91781802|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||||TWO_SIDED|95.0|-1.38|6.85||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.85|-1.38|
91589467|NCT02113579|183068836|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.67|STANDARD_ERROR_OF_MEAN|1.809|<|0.001|TWO_SIDED|95.0|-11.23|-4.11||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.11|-11.23|<0.001
91781803|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|2.67|||||TWO_SIDED|95.0|-0.209|5.56||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.56|-0.209|
91589468|NCT02113579|183068837|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|2.78|6.62||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.62|2.78|<0.001
91589469|NCT02113579|183068838|SUPERIORITY_OR_OTHER||Success rate difference (%)|15.44||||0.002|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 2, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||0.002
91589470|NCT02113579|183068839|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.67|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-9.92|-3.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.43|-9.92|<0.001
91589471|NCT02113579|183068840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.52|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-15.3|-7.75||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-7.75|-15.30|<0.001
91589472|NCT02113579|183068841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.422||0.023|TWO_SIDED|95.0|-6.04|-0.45||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.45|-6.04|0.023
91648107|NCT03550794|183188759|OTHER||Odds Ratio (OR)|0.43||||0.07|TWO_SIDED|95.0|0.17|1.06||P-value from logistic regression model controlling for site|Regression, Logistic|||||1.06|0.17|0.07
91648108|NCT03550794|183188760|OTHER||Mean Difference (Final Values)|0.96||||0.79|TWO_SIDED|95.0|0.71|1.3||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 72 hours.~Missing lactate imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||1.30|0.71|0.79
91648109|NCT03550794|183188762|OTHER||Mean Difference (Final Values)|-1.53||||0.16|TWO_SIDED|95.0|-3.63|0.58||"Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.~Missing SOFA imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.58|-3.63|0.16
91781804|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|0.541|||||TWO_SIDED|95.0|-2.94|4.02||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.02|-2.94|
91781805|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|5.26|||||TWO_SIDED|95.0|1.09|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.43|1.09|
91781806|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|-0.322|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|-0.322|
91781807|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-6.46|||||TWO_SIDED|95.0|-11.5|-1.41||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.41|-11.5|
91589473|NCT02113579|183068842|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|1.873|<|0.001|TWO_SIDED|95.0|-11.29|-3.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||-3.93|-11.29|<0.001
91589474|NCT00726622|183068845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91589475|NCT02462928|183068861|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-3.8|||||TWO_SIDED|95.1|-8.2|0.3|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.3|-8.2|
91589476|NCT02462928|183068861|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-4.2|||||TWO_SIDED|95.1|-8.7|0.0|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.0|-8.7|
91589477|NCT02462928|183068862|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares (LS) Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-4.7|-0.1|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-0.1|-4.7|
91589478|NCT02462928|183068862|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-6.0|-1.3|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-1.3|-6.0|
91589479|NCT02462928|183068863|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|8.6|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-3.8|20.9|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||20.9|-3.8|
91589480|NCT02462928|183068863|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-10.1|14.7|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||14.7|-10.1|
91589481|NCT02462928|183068864|SUPERIORITY||Percentage Difference|-4.7|||||TWO_SIDED|95.1|-11.5|2.1|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||2.1|-11.5|
91589482|NCT02462928|183068864|SUPERIORITY||Percentage Difference|-8.2|||||TWO_SIDED|95.1|-14.7|-1.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||-1.5|-14.7|
91589483|NCT02462928|183068865|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-3.7|0.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||-0.0|-3.7|
91589484|NCT02462928|183068865|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-2.7|1.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||1.0|-2.7|
91589485|NCT00395863|183068866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test|||||||< 0.0001
91589486|NCT00395863|183068866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
91589487|NCT00395863|183068866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||< 0.0001
91781808|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|0.171|||||TWO_SIDED|95.0|-5.21|5.56||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.56|-5.21|
91781809|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-3.09|||||TWO_SIDED|95.0|-6.73|0.557||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.557|-6.73|
91589488|NCT00395863|183068867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Reader 1|wilcoxon signed-rank test|||||||0.0001
91589489|NCT00395863|183068867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Reader 2|wilcoxon signed-rank test|||||||0.001
91589490|NCT00395863|183068867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||Reader 3|wilcoxon signed-rank test|||||||0.0002
91589491|NCT00395863|183068868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Reader 1|wilcoxon signed-rank test|||||||<0.0001
91589492|NCT00395863|183068868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
91589493|NCT00395863|183068868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||<0.0001
91589494|NCT00395863|183068869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|0.22|<|0.0001||95.0|0.14|0.3||Mean difference of MultiHance minus Magnevist for change from baseline|t-test, 2 sided|||||0.30|0.14|<0.0001
91589495|NCT00395863|183068870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.2|<|0.0001||95.0|0.22|0.38||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.38|0.22|<0.0001
91589496|NCT00395863|183068871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.19|<|0.0001||95.0|0.18|0.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.33|0.18|<0.0001
91589497|NCT00395863|183068872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99|STANDARD_DEVIATION|59.78||0.0062||95.0|20.72|61.26||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||61.26|20.72|0.0062
91589498|NCT00395863|183068873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.95|STANDARD_DEVIATION|48.64||0.0027||95.0|16.57|45.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||45.33|16.57|0.0027
91781810|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||||TWO_SIDED|95.0|-3.61|6.53||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.53|-3.61|
91589499|NCT00395863|183068874|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|25.04|STANDARD_DEVIATION|37.37||0.02||95.0|12.41|37.67||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||37.67|12.41|0.02
91589500|NCT00395863|183068875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.77|STANDARD_DEVIATION|48.51||0.0019||95.0|14.28|51.25||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||51.25|14.28|0.0019
91589501|NCT00395863|183068876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.61|STANDARD_DEVIATION|43.16||0.0008||95.0|16.75|50.47||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||50.47|16.75|0.0008
91589502|NCT00395863|183068877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.72|STANDARD_DEVIATION|48.5||0.0026||95.0|14.63|52.81||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||52.81|14.63|0.0026
91589503|NCT01448213|183068903|SUPERIORITY_OR_OTHER|||||||0.17|||||||Log Rank|||||||0.17
91589504|NCT01448213|183068904|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
91589505|NCT03503513|183068908|SUPERIORITY||Risk Ratio (RR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.03|0.2|||differences in incidence rate ratio|An incidence rate ratio per person/month was determined by comparing the total number of UTIs in relation to time points.||comparison between pre and during treatment rates of UTI||0.20|0.03|<0.0001
91589506|NCT03503513|183068909|SUPERIORITY||Mean Difference (Final Values)|-3.8|STANDARD_DEVIATION|6.13|<|0.06|TWO_SIDED|95.0|-7.9|0.3||a priori threshold p value of \<0.05|t-test, 2 sided||Baseline to end of 6 month treatment score comparisons; (higher numbers represent more symptoms or complications)|NBSS Domain score for incontinence pre-post comparison; small sample size did not allow for power calculation.||0.3|-7.9|<0.06
91589507|NCT03503513|183068909|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.09|<|0.39|TWO_SIDED|95.0|-3.8|1.7||a priori threshold p\<0.05|t-test, 2 sided||(higher numbers represent more symptoms or complications)|NBSS Domain score for storage and voiding; pre-post comparison. Due to small sample size (n=11) no power calculations were conducted.||1.7|-3.8|<0.39
91589508|NCT03503513|183068909|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|3.99|<|0.14|TWO_SIDED|95.0|-4.6|0.8|||t-test, 2 sided||Higher numbers represent more symptoms or complications referred as consequences.|Pre and post test comparisons of mean NBSS scores for the consequences domain. Power calculations were not conducted due to small sample size.||0.8|-4.6|<0.14
91589509|NCT03503513|183068910|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.99|<|0.34|TWO_SIDED|95.0|-6.8|2.6|||t-test, 2 sided|||||2.6|-6.8|<0.34
91781811|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|11.4|||||TWO_SIDED|95.0|5.99|16.8||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|5.99|
91781812|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|7.15|||||TWO_SIDED|95.0|3.49|10.8||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.8|3.49|
91589510|NCT00733304|183068989|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-3.18|2.31||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||2.31|-3.18|
91589511|NCT00733304|183068989|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.659|||TWO_SIDED|95.0|-7.13|-0.46||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||-0.46|-7.13|
91589512|NCT00733304|183068989|SUPERIORITY||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|1.672|||TWO_SIDED|95.0|-7.52|-0.78||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||-0.78|-7.52|
91589513|NCT00733304|183068989|SUPERIORITY||Mean Difference (Net)|-4.03|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-7.53|0.53||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||0.53|-7.53|
91589514|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|8.28|STANDARD_ERROR_OF_MEAN|16.899|||TWO_SIDED|95.0|-25.72|42.29||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||For Month 1 versus Screening visit||42.29|-25.72|
91589515|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|17.177|||TWO_SIDED|95.0|-35.73|33.31||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||33.31|-35.73|
91589516|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|-5.11|STANDARD_ERROR_OF_MEAN|17.958|||TWO_SIDED|95.0|-41.08|30.86||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||30.86|-41.08|
91589517|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|-9.92|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-47.83|28.0||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||28.00|-47.83|
91589518|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-35.5|40.33||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||40.33|-35.50|
91781813|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|0.0309|||||TWO_SIDED|95.0|-5.28|5.34||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.34|-5.28|
91781814|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-5.93|3.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-5.93|
91589519|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|9.05|STANDARD_ERROR_OF_MEAN|20.931|||TWO_SIDED|95.0|-33.09|51.2||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 1 versus Screening visit||51.20|-33.09|
91781815|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-0.333|||||TWO_SIDED|95.0|-4.35|3.68||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.68|-4.35|
91521377|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.0||||0.32|TWO_SIDED|95.0|-21.0|65.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||65|-21|0.320
91589520|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|-1.24|STANDARD_ERROR_OF_MEAN|21.29|||TWO_SIDED|95.0|-44.05|41.57||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||41.57|-44.05|
91781816|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-2.11|||||TWO_SIDED|95.0|-7.42|3.2||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.20|-7.42|
91781817|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|4.36|||||TWO_SIDED|95.0|-0.404|9.12||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.12|-0.404|
91589521|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|15.39|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-28.28|59.06||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||59.06|-28.28|
91589522|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|-16.82|STANDARD_ERROR_OF_MEAN|22.183|||TWO_SIDED|95.0|-61.28|27.63||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||27.63|-61.28|
91589523|NCT00733304|183068990|SUPERIORITY||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-45.83|41.51||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||41.51|-45.83|
91589524|NCT00528567|183068993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.07|||Log Rank|Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||||1.07|0.72|0.1810
91589525|NCT00528567|183068995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5247|TWO_SIDED|95.0|0.74|1.17|||Log Rank|Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery||||1.17|0.74|0.5247
91589526|NCT00528567|183068997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1966|TWO_SIDED|95.0|0.71|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.71|0.1966
91589527|NCT00528567|183068998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2318|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2318
91589528|NCT00528567|183069001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2792|TWO_SIDED|95.0|0.72|1.1|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.10|0.72|0.2792
91589529|NCT00528567|183069003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1832|TWO_SIDED|95.0|0.72|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.72|0.1832
91589530|NCT00528567|183069005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3309|TWO_SIDED|95.0|0.72|1.12|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.12|0.72|0.3309
91589531|NCT05696236|183069055|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
91589532|NCT05696236|183069056|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91648110|NCT01864525|183188764|SUPERIORITY|||||||0.0216||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0216
91648111|NCT01864525|183188764|SUPERIORITY|||||||0.0499||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0499
91781818|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-0.119|||||TWO_SIDED|95.0|-4.14|3.9||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.90|-4.14|
91781819|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-4.16|||||TWO_SIDED|95.0|-9.69|1.37||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.37|-9.69|
91781820|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-4.76|||||TWO_SIDED|95.0|-10.2|0.718||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.718|-10.2|
91781821|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-4.2|||||TWO_SIDED|95.0|-8.71|0.32||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.320|-8.71|
91589533|NCT05696236|183069057|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91589534|NCT05341700|183069059|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of PINP between RUN and RUN+J.||||0.246
91589535|NCT05341700|183069060|SUPERIORITY|||||||0.714|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of CTX between RUN and RUN+J.||||0.714
91589536|NCT05341700|183069061|SUPERIORITY|||||||0.309|||||||Mixed Models Analysis|||||||0.309
91589537|NCT05341700|183069062|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of IGF1 between RUN and RUN+J.||||0.308
91589538|NCT05341700|183069063|SUPERIORITY|||||||0.207|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of ferritin between RUN and RUN+J.||||0.207
91589539|NCT01829360|183069064|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|The significance of fixed effects (e.g.,treatment) was evaluated using Wald tests||||||<0.05
91589540|NCT01829360|183069064|OTHER|A secondary analysis was performed to examine individual differences in treatment outcomes. This was done collapsed across all arms because the difference between the arms/treatments was not significant in the primary analysis. This was done by adding predictors to the primary analysis model to determine if learner characteristics were significantly related to growth in word defining. All continuous learner characteristics were grand mean centered.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91589541|NCT01829360|183069065|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||The interim definition data were analyzed with the primary pre-/post-definition data to capture growth across the entire treatment period.||||<0.05
91589542|NCT01026142|183069067|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0731|TWO_SIDED|95.0|0.65|1.02||The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.|Log Rank|Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.|The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.|"The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:~H0: IRF PFS\<pertuzumab\> = IRF PFS\<control\> vs. H1: IRF PFS\<pertuzumab\> ≠ IRF PFS\<control\>"||1.02|0.65|0.0731
91589543|NCT00778622|183069082|SUPERIORITY_OR_OTHER|||||||0.0806||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.||"Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method CI for mean for one group in nQuery Advisor v6.0."||||0.0806
91589544|NCT00778622|183069082|SUPERIORITY_OR_OTHER|||||||0.1984||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.1984
91589545|NCT00778622|183069082|SUPERIORITY_OR_OTHER|||||||0.0232||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.0232
91589546|NCT00778622|183069082|SUPERIORITY_OR_OTHER|||||||0.3589||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.3589
91589547|NCT00778622|183069083|SUPERIORITY_OR_OTHER|||||||0.4614||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.||||||0.4614
91589548|NCT00778622|183069083|SUPERIORITY_OR_OTHER|||||||0.4696||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.4696
91589549|NCT00778622|183069083|SUPERIORITY_OR_OTHER|||||||0.5305||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.5305
91589550|NCT00778622|183069083|SUPERIORITY_OR_OTHER|||||||0.9145||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.9145
91589551|NCT00778622|183069084|SUPERIORITY_OR_OTHER|||||||0.0305||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.||||||0.0305
91589552|NCT00778622|183069084|SUPERIORITY_OR_OTHER|||||||0.008||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0080
91709100|NCT03035916|183311327|OTHER|||||||0.406|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.406
91781822|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||||TWO_SIDED|95.0|-2.34|8.74||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.74|-2.34|
91781823|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||||TWO_SIDED|95.0|-1.54|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.43|-1.54|
91781824|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|4.84|||||TWO_SIDED|95.0|0.319|9.37||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.37|0.319|
91589553|NCT00778622|183069084|SUPERIORITY_OR_OTHER|||||||0.0422||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0422
91589554|NCT00778622|183069085|SUPERIORITY_OR_OTHER|||||||0.4508||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.||||||0.4508
91589555|NCT00778622|183069085|SUPERIORITY_OR_OTHER|||||||0.0526||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0526
91589556|NCT00778622|183069085|SUPERIORITY_OR_OTHER|||||||0.1295||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.1295
91781825|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||||TWO_SIDED|95.0|-3.44|8.12||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.12|-3.44|
91589557|NCT00778622|183069086|SUPERIORITY_OR_OTHER|||||||0.1431||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.||||||0.1431
91589558|NCT00778622|183069086|SUPERIORITY_OR_OTHER|||||||0.4066||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4066
91589559|NCT00778622|183069086|SUPERIORITY_OR_OTHER|||||||0.4071||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4071
91781826|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|1.89|||||TWO_SIDED|95.0|-3.22|7.0||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.00|-3.22|
91781827|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|1.83|||||TWO_SIDED|95.0|-1.85|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.52|-1.85|
91781828|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|0.327|||||TWO_SIDED|95.0|-5.45|6.1||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.10|-5.45|
91781829|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|3.18|||||TWO_SIDED|95.0|-1.93|8.29||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||8.29|-1.93|
91781830|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|2.12|||||TWO_SIDED|95.0|-1.56|5.81||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.81|-1.56|
91781831|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|||||TWO_SIDED|95.0|-6.79|3.59||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.59|-6.79|
91781832|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-0.163|||||TWO_SIDED|95.0|-5.0|4.68||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||4.68|-5.00|
91589560|NCT00778622|183069087|SUPERIORITY_OR_OTHER|||||||0.021||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.||||||0.0210
91589561|NCT00778622|183069087|SUPERIORITY_OR_OTHER|||||||0.2507||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.2507
91589562|NCT00778622|183069087|SUPERIORITY_OR_OTHER|||||||0.6546||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.6546
91589563|NCT02469896|183069140|SUPERIORITY||Risk Ratio (RR)|0.875||||0.602|TWO_SIDED|95.0|0.556|1.377|||Fisher Exact|||||1.377|0.556|0.602
91589564|NCT02469896|183069141|SUPERIORITY||||||||||||||||||No statistical data was obtain because no patients died during the trial.|||
91589565|NCT02469896|183069142|SUPERIORITY||Slope|0.099||||0.922|TWO_SIDED|95.0|-1.902|2.099||Unadjusted|Mixed Models Analysis|||||2.099|-1.902|0.922
91589566|NCT02469896|183069143|SUPERIORITY||Difference of slopes|-0.008||||0.983|TWO_SIDED|95.0|-0.761|0.745|||Mixed Models Analysis|||||0.745|-0.761|0.983
91589567|NCT02469896|183069145|SUPERIORITY||Ratio of geometric means|1.15||||0.684|TWO_SIDED|95.0|0.566|2.337|||t-test, 2 sided|||PBMC IL-6 fold-change||2.337|0.566|0.684
91589568|NCT02469896|183069145|SUPERIORITY||Ratio of geometric means|1.344||||0.663|TWO_SIDED|95.0|0.331|2.08|||t-test, 2 sided|||||2.080|0.331|0.663
91589569|NCT02469896|183069145|SUPERIORITY||Ratio of geometric means|1.198||||0.5|TWO_SIDED|95.0|0.691|2.08|||t-test, 2 sided|||||2.080|0.691|0.500
91589570|NCT02469896|183069146|SUPERIORITY||Ratio of fold change|0.047|||<|0.001|TWO_SIDED|95.0|0.01|0.217|||Mixed Models Analysis|||||0.217|0.010|<0.001
91589571|NCT02469896|183069146|SUPERIORITY||Ratio of fold change|1.306||||0.247|TWO_SIDED|95.0|0.828|2.059|||Mixed Models Analysis|||||2.059|0.828|0.247
91589572|NCT02469896|183069146|SUPERIORITY||Ratio of fold change|19.591|||<|0.001|TWO_SIDED|95.0|11.143|34.446|||Mixed Models Analysis|||||34.446|11.143|<0.001
91589573|NCT02469896|183069146|SUPERIORITY||Ratio of fold change|1.264||||0.185|TWO_SIDED|95.0|0.892|1.791|||Mixed Models Analysis|||||1.791|0.892|0.185
91589574|NCT02469896|183069146|SUPERIORITY||Ratio of fold change|1.396||||0.427|TWO_SIDED|95.0|0.608|3.206|||Mixed Models Analysis|||||3.206|0.608|0.427
91589575|NCT02469896|183069146|SUPERIORITY||Ratio of fold change|0.893||||0.285|TWO_SIDED|95.0|0.725|1.1|||Mixed Models Analysis|||||1.100|0.725|0.285
91589576|NCT02469896|183069147|SUPERIORITY||Ratio of fold change|0.167||||0.011|TWO_SIDED|95.0|0.043|0.643|||Mixed Models Analysis|||||0.643|0.043|0.011
91589577|NCT02469896|183069147|SUPERIORITY||Ratio of fold change|0.741||||0.604|TWO_SIDED|95.0|0.228|2.405|||Mixed Models Analysis|||||2.405|0.228|0.604
91589578|NCT02469896|183069147|SUPERIORITY||Ratio of fold change|2.94|||<|0.001|TWO_SIDED|95.0|1.823|4.74|||Mixed Models Analysis|||||4.740|1.823|<0.001
91589579|NCT02469896|183069147|SUPERIORITY||Ratio of fold change|1.078||||0.587|TWO_SIDED|95.0|0.813|1.431|||Mixed Models Analysis|||||1.431|0.813|0.587
91589580|NCT02469896|183069147|SUPERIORITY||Ratio of fold change|1.078||||0.697|TWO_SIDED|95.0|0.728|1.595|||Mixed Models Analysis|||||1.595|0.728|0.697
91589581|NCT02469896|183069148|SUPERIORITY||Ratio of fold change|1.785|||<|0.001|TWO_SIDED|95.0|1.502|2.121|||Mixed Models Analysis|||||2.121|1.502|<0.001
91589582|NCT02510560|183069150|SUPERIORITY|||||||0.115|||||||Stratified Van Elteren Test|||||||0.115
91589583|NCT02510560|183069150|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
91589584|NCT02510560|183069151|SUPERIORITY|||||||0.714|||||||Stratified Van Elteren Test|||||||0.714
91589585|NCT02510560|183069151|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
91589586|NCT03684642|183069161|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<=0.3%.|Least Square (LS) Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.14||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.14|-0.20|
91589587|NCT03684642|183069161|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was \<=0.3%.|LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.25|0.09||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.09|-0.25|
91589588|NCT03684642|183069161|SUPERIORITY|||||||0.7064||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.7064
91589589|NCT03684642|183069161|SUPERIORITY|||||||0.3427||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.3427
91589590|NCT04556396|183069167|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.01|TWO_SIDED|95.0|0.1|0.4|||Chi-squared|||||0.4|0.1|<0.01
91589591|NCT04908189|183069232|SUPERIORITY||Adjusted Mean Difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.3031|-0.6455|<0.0001
91589592|NCT04908189|183069233|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.0438|-0.1814|0.0013
91589593|NCT04908189|183069235|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||3.105|0.980|0.0002
91589594|NCT04908189|183069238|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||2.0|-0.4|0.2017
91589595|NCT04908189|183069242|SUPERIORITY||Adjusted mean difference|0.0643|STANDARD_ERROR_OF_MEAN|0.02831||0.0231|TWO_SIDED|95.0|0.0088|0.1198|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1198|0.0088|0.0231
91589596|NCT04908189|183069242|SUPERIORITY||Adjusted mean difference|0.0085|STANDARD_ERROR_OF_MEAN|0.03126||0.7865|TWO_SIDED|95.0|-0.0528|0.0697|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0697|-0.0528|0.7865
91589597|NCT04908189|183069242|SUPERIORITY||Adjusted mean difference|-0.0515|STANDARD_ERROR_OF_MEAN|0.03386||0.128|TWO_SIDED|95.0|-0.1179|0.0148|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||0.0148|-0.1179|0.1280
91589598|NCT04908189|183069242|SUPERIORITY||Adjusted mean differnce|-0.0541|STANDARD_ERROR_OF_MEAN|0.0346||0.118|TWO_SIDED|95.0|-0.1219|0.0137|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.0137|-0.1219|0.1180
91589599|NCT04908189|183069242|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.0438|-0.1814|0.0013
91589600|NCT04908189|183069247|SUPERIORITY||Adjusted mean difference|0.692|STANDARD_ERROR_OF_MEAN|0.4384||0.1147|TWO_SIDED|95.0|-0.168|1.551|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||1.551|-0.168|0.1147
91589601|NCT04908189|183069247|SUPERIORITY||Adjusted mean difference|1.999|STANDARD_ERROR_OF_MEAN|0.5147||0.0001|TWO_SIDED|95.0|0.991|3.008|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||3.008|0.991|0.0001
91589602|NCT04908189|183069247|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||3.105|0.980|0.0002
91589603|NCT04908189|183069251|SUPERIORITY||Adjusted mean difference|-0.284|STANDARD_ERROR_OF_MEAN|0.567||0.6159|TWO_SIDED|95.0|-1.396|0.827|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.827|-1.396|0.6159
91589604|NCT04908189|183069251|SUPERIORITY||Adjusted mean difference|0.829|STANDARD_ERROR_OF_MEAN|0.625||0.1847|TWO_SIDED|95.0|-0.396|2.054|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||2.054|-0.396|0.1847
91589605|NCT04908189|183069251|SUPERIORITY||Adjusted mean difference|1.145|STANDARD_ERROR_OF_MEAN|0.673||0.0888|TWO_SIDED|95.0|-0.174|2.464|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.464|-0.174|0.0888
91589606|NCT04908189|183069252|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.1924|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.3|-1.6|0.1924
91589607|NCT04908189|183069252|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.7601|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.8|-1.20|0.7601
91589608|NCT04908189|183069252|SUPERIORITY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0303|TWO_SIDED|95.0|0.1|2.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||2.4|0.1|0.0303
91589609|NCT04908189|183069252|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.63||0.4747|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||1.7|-0.8|0.4747
91589610|NCT04908189|183069252|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.0|-0.4|0.2017
91589611|NCT04908189|183069254|SUPERIORITY||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.1015||0.4459|TWO_SIDED|95.0|-0.276|0.122|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.122|-0.276|0.4459
91589612|NCT04908189|183069254|SUPERIORITY||Adjusted mean difference|-0.232|STANDARD_ERROR_OF_MEAN|0.1164||0.0461|TWO_SIDED|95.0|-0.46|-0.004|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||-0.004|-0.460|0.0461
91589613|NCT04908189|183069254|SUPERIORITY||Adjusted mean difference|-0.598|STANDARD_ERROR_OF_MEAN|0.1321|<|0.0001|TWO_SIDED|95.0|-0.857|-0.339|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.339|-0.857|<0.0001
91589614|NCT04908189|183069254|SUPERIORITY||Adjusted mean difference|-0.605|STANDARD_ERROR_OF_MEAN|0.1416|<|0.0001|TWO_SIDED|95.0|-0.882|-0.327|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.327|-0.882|<0.0001
91589615|NCT04908189|183069254|SUPERIORITY||Adjusted mean difference|-0.786|STANDARD_ERROR_OF_MEAN|0.1455|<|0.0001|TWO_SIDED|95.0|-1.071|-0.501|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.501|-1.071|<0.0001
91589616|NCT04908189|183069255|SUPERIORITY||Adjusted mean difference|0.3525|STANDARD_ERROR_OF_MEAN|0.9227||0.7025|TWO_SIDED|95.0|-1.456|2.1609|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||2.1609|-1.4560|0.7025
91589617|NCT04908189|183069255|SUPERIORITY||Adjusted mean difference|-1.373|STANDARD_ERROR_OF_MEAN|0.93331||0.1413|TWO_SIDED|95.0|-3.2023|0.4562|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.4562|-3.2023|0.1413
91589618|NCT04908189|183069255|SUPERIORITY||Adjused mean difference|-3.7522|STANDARD_ERROR_OF_MEAN|1.10374||0.0007|TWO_SIDED|95.0|-5.9155|-1.589|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-1.5890|-5.9155|0.0007
91589619|NCT04908189|183069255|SUPERIORITY||Adjusted mean difference|-4.8072|STANDARD_ERROR_OF_MEAN|1.13857|<|0.0001|TWO_SIDED|95.0|-7.0388|-2.5757|||ANOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-2.5757|-7.0388|<0.0001
91589620|NCT04908189|183069255|SUPERIORITY||Adjusted mean difference|-6.2006|STANDARD_ERROR_OF_MEAN|1.2284|<|0.0001|TWO_SIDED|95.0|-8.6082|-3.793|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-3.7930|-8.6082|<0.0001
91589621|NCT04908189|183069259|SUPERIORITY||Adjusted mean difference|0.0318|STANDARD_ERROR_OF_MEAN|0.05613||0.5707|TWO_SIDED|95.0|-0.0782|0.1419|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1419|-0.0782|0.5707
91589622|NCT04908189|183069259|SUPERIORITY||Adjusted mean difference|-0.0833|STANDARD_ERROR_OF_MEAN|0.06303||0.1862|TWO_SIDED|95.0|-0.2069|0.0402|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0402|-0.2069|0.1862
91589623|NCT04908189|183069259|SUPERIORITY||Adjusted mean difference|-0.2958|STANDARD_ERROR_OF_MEAN|0.07854||0.0002|TWO_SIDED|95.0|-0.4497|-0.1418|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.1418|-0.4497|0.0002
91589624|NCT04908189|183069259|SUPERIORITY||Adjusted mean difference|-0.3262|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.4889|-0.1635|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.1635|-0.4889|<0.0001
91781833|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|-0.829|||||TWO_SIDED|95.0|-5.2|3.54||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.54|-5.20|
91781834|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|1.95|||||TWO_SIDED|95.0|-3.27|7.17||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.17|-3.27|
91589625|NCT04908189|183069259|SUPERIORITY||Adjusted mean difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3031|-0.6455|<0.0001
91781835|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|3.71|||||TWO_SIDED|95.0|-1.17|8.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.59|-1.17|
91589626|NCT04908189|183069262|SUPERIORITY||Adjusted mean difference|-0.0758|STANDARD_ERROR_OF_MEAN|0.07069||0.2836|TWO_SIDED|95.0|-0.2144|0.0627|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0627|-0.2144|0.2836
91589627|NCT04908189|183069262|SUPERIORITY||Adjusted mean difference|-0.5548|STANDARD_ERROR_OF_MEAN|0.09431|<|0.0001|TWO_SIDED|95.0|-0.7396|-0.3699|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.3699|-0.7396|<0.0001
91589628|NCT04908189|183069262|SUPERIORITY||Adjusted mean difference|-0.5835|STANDARD_ERROR_OF_MEAN|0.10162|<|0.0001|TWO_SIDED|95.0|-0.7826|-0.3843|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3843|-0.7826|<0.0001
91781836|NCT01263197|183442973|SUPERIORITY_OR_OTHER||LS mean difference|4.28|||||TWO_SIDED|95.0|-0.103|8.67||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.67|-0.103|
91781837|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-3.9|1.44||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.44|-3.90|
91781838|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|1.05|||||TWO_SIDED|95.0|-1.91|4.02||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.02|-1.91|
91589629|NCT04908189|183069263|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.2143|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.1|-0.4|0.2143
91589630|NCT04908189|183069263|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.2|-0.8|0.0001
91589631|NCT04908189|183069263|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.4|-1.0|<0.0001
91648112|NCT01864525|183188764|SUPERIORITY|||||||0.0339||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0339
91589632|NCT04908189|183069263|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.4|-0.9|<0.0001
91589633|NCT04908189|183069266|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.801||0.8316|TWO_SIDED|95.0|-3.91|3.15|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Absenteeism||3.15|-3.91|0.8316
91589634|NCT04908189|183069266|SUPERIORITY||Adjusted mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.827||0.106|TWO_SIDED|95.0|-6.54|0.63|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Presenteeism||0.63|-6.54|0.1060
91589635|NCT04908189|183069266|SUPERIORITY||Adjusted mean difference|-2.71|STANDARD_ERROR_OF_MEAN|1.918||0.1578|TWO_SIDED|95.0|-6.47|1.05|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Work Productivity||1.05|-6.47|0.1578
91589636|NCT04908189|183069266|SUPERIORITY||Adjusted mean difference|-7.59|STANDARD_ERROR_OF_MEAN|1.719|<|0.0001|TWO_SIDED|95.0|-10.96|-4.22|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Activity Impairment||-4.22|-10.96|<0.0001
91589637|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|-0.0026|STANDARD_ERROR_OF_MEAN|0.01224||0.8487|TWO_SIDED|95.0|-0.0291|0.0239|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Utility Score||0.0239|-0.0291|0.8487
91589638|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|0.0365|STANDARD_ERROR_OF_MEAN|0.01531||0.0171|TWO_SIDED|95.0|0.0065|0.0665|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Utility Score||0.0665|0.0065|0.0171
91589639|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9254|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Mobility||0.1|-0.1|0.9254
91589640|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0566|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Mobility||0.0|-0.2|0.0566
91589641|NCT04908189|183069267|SUPERIORITY||Ajudted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.8933|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Self-Care||0.1|-0.1|0.8933
91709101|NCT03035916|183311327|OTHER|||||||0.042|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.042
91589642|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0738|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Self-Care||0.0|-0.2|0.0738
91589643|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6176|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Usual Activities||0.1|-0.1|0.6176
91709102|NCT03035916|183311327|OTHER|||||||0.655|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.655
91589644|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1544|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Usual Activities||0.0|-0.2|0.1544
91589645|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4707|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Pain/Discomfort||0.1|-0.2|0.4707
91589646|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0114|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Pain/Discomfort||0.0|-0.3|0.0114
91709103|NCT03035916|183311327|OTHER|||||||0.262|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.262
91589647|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6594|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Anxiety/Depression||0.1|-0.1|0.6594
91589648|NCT04908189|183069267|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7123|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Anxiety/Depression||0.1|-0.1|0.7123
91648113|NCT01864525|183188764|SUPERIORITY|||||||0.045||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0450
91589649|NCT04908189|183069268|SUPERIORITY||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.498||0.9834|TWO_SIDED|95.0|-0.99|0.97|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.97|-0.99|0.9834
91589650|NCT04908189|183069268|SUPERIORITY||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.565||0.6099|TWO_SIDED|95.0|-1.39|0.82|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.82|-1.39|0.6099
91589651|NCT04908189|183069268|SUPERIORITY||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.538||0.2205|TWO_SIDED|95.0|-1.71|0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||0.40|-1.71|0.2205
91589652|NCT00607022|183069269|OTHER|Kruskal-Wallis values between each loading group and for Wilcoxon Signed Rank for measures on the mesial vs buccal side of the implant.|||||>|0.05||||||0.0501 \< p \< 0.9797|Kruskal-Wallis|Kruskal-Wallis test evaluated ISQ at each time point..||Comparison between loading groups at 16 weeks - loading at baseline, Loading at 6 weeks, and loading at 12 weeks. Scores for all groups were compared at 16 weeks from implant placement..||||>0.05
91589653|NCT03622619|183069298|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91589654|NCT03622619|183069299|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91589655|NCT03622619|183069300|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
91589656|NCT03622619|183069301|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Burning/stinging||||||0.90
91589657|NCT03622619|183069301|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Grittiness/foreign body sensation||||||0.30
91589658|NCT03622619|183069301|SUPERIORITY|||||||0.66||||||Dryness|Wilcoxon (Mann-Whitney)|||||||0.66
91589659|NCT03622619|183069301|SUPERIORITY|||||||0.14||||||Blurred vision|Wilcoxon (Mann-Whitney)|||||||0.14
91589660|NCT03622619|183069301|SUPERIORITY|||||||0.3||||||Overall discomfort|Wilcoxon (Mann-Whitney)|||||||0.30
91589661|NCT03610165|183069309|SUPERIORITY||Median Difference (Final Values)|0.0||||0.757|TWO_SIDED|95.0|-0.03|0.04|||Wilcoxon (Mann-Whitney)|||||0.04|-0.03|0.757
91589662|NCT03610165|183069310|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.715|TWO_SIDED|95.0|-12.0|7.0|||Wilcoxon (Mann-Whitney)|||||7|-12|0.715
91709104|NCT03035916|183311327|OTHER|||||||0.143|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.143
91709105|NCT03035916|183311327|OTHER|||||||0.494|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.494
91589663|NCT03610165|183069311|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.328|TWO_SIDED|95.0|-3.3|1.0|||Wilcoxon (Mann-Whitney)|||||1|-3.3|0.328
91589664|NCT03610165|183069312|SUPERIORITY||Median Difference (Final Values)|0.0||||0.376|TWO_SIDED|95.0|-0.001|0.011|||Wilcoxon (Mann-Whitney)|||||0.011|-0.001|0.376
91589665|NCT03610165|183069313|SUPERIORITY||Median Difference (Final Values)|0.0||||0.226|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.226
91589666|NCT03610165|183069314|SUPERIORITY||Median Difference (Final Values)|0.0||||0.61|TWO_SIDED|95.0|-0.67|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|-0.67|0.610
91589667|NCT03610165|183069315|SUPERIORITY||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.302
91589668|NCT03610165|183069316|SUPERIORITY||Median Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.67|0.67|||Wilcoxon (Mann-Whitney)|||||0.67|-0.67|0.889
91589669|NCT03610165|183069317|SUPERIORITY||Median Difference (Final Values)|0.0||||0.403|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.403
91589670|NCT02383589|183069324|SUPERIORITY||Difference in proportion|30.8|||<|0.0001|TWO_SIDED|95.0|14.7|45.15||The analysis was stratified by the stratification factors applied at randomization.|Cochran-Mantel-Haenszel|||||45.15|14.70|<0.0001
91589671|NCT02383589|183069325|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
91589672|NCT02383589|183069326|SUPERIORITY||Adjusted Rate Ratio|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.29||The model was adjusted for the following covariates in addition to log (each participant's duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.|Negative Binominal Regression|||||0.29|0.05|<0.0001
91589673|NCT02383589|183069327|SUPERIORITY||Hazard Ratio (HR)|4.83||||0.0003|TWO_SIDED|95.0|1.97|11.81||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||11.81|1.97|0.0003
91589674|NCT02383589|183069328|SUPERIORITY||Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.06|0.39||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||0.39|0.06|<0.0001
91709106|NCT03035916|183311327|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
91709107|NCT03035916|183311327|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
91589675|NCT02383589|183069329|SUPERIORITY||Difference in Estimated Means|-2.872||||0.0012|TWO_SIDED|95.0|-4.577|-1.167||P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment|Mixed Model Repeated Measures|||||-1.167|-4.577|0.0012
91589676|NCT00447382|183069333|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.04||||0.649||95.0|0.86|1.26|||ANOVA|Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data).|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|"Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA."||1.26|0.86|0.649
91589677|NCT00447382|183069335|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.03||||0.758||95.0|-0.21|0.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.15|-0.21|0.758
91589678|NCT00447382|183069336|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.1||||0.812||95.0|-0.89|0.7|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.7|-0.89|0.812
91589679|NCT00447382|183069338|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|0.93||||0.15||95.0|0.84|1.03|||ANOVA|Adjustments:Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.03|0.84|0.15
91589680|NCT00447382|183069339|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.0||||0.966||95.0|0.87|1.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.15|0.87|0.966
91589681|NCT00789867|183069357|OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
91589682|NCT00789867|183069358|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
91589683|NCT00789867|183069359|OTHER|||||||0.06|||||||Kruskal-Wallis|||||||0.06
91589684|NCT00789867|183069360|OTHER|||||||0.08|||||||Kruskal-Wallis|||||||0.08
91589685|NCT00789867|183069361|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
91589686|NCT00789867|183069362|OTHER|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91589687|NCT00594516|183069363|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09||||95.0|-0.09|0.28||||||Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.||0.28|-0.09|
91589688|NCT01493557|183069368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.31||||0.2554|TWO_SIDED|95.0|-6.54|29.49|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||29.49|-6.54|0.2554
91589689|NCT01493557|183069369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.3165|TWO_SIDED|95.0|-11.24|24.58|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||24.58|-11.24|0.3165
91589690|NCT01493557|183069370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.41||||0.0273|TWO_SIDED|95.0|0.71|35.98|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||35.98|0.71|0.0273
91589691|NCT01493557|183069371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52||||0.7104|TWO_SIDED|95.0|-44.22|28.4|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.40|-44.22|0.7104
91589692|NCT01493557|183069372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81||||1|TWO_SIDED|95.0|-32.94|40.44|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||40.44|-32.94|1.0000
91589693|NCT01493557|183069373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.71||||1|TWO_SIDED|95.0|-41.25|28.77|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.77|-41.25|1.0000
91589694|NCT01493557|183069377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-9.9|8.9|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for the Duration of gastrointestinal symptoms (GIS).||8.9|-9.9|
91589695|NCT01493557|183069377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.3|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||6.3|-3.5|
91589696|NCT01493557|183069377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.2|||||TWO_SIDED|95.0|-8.2|48.5|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||48.5|-8.2|
91589697|NCT02973425|183069378|OTHER||Cox Proportional Hazard|1.68||||0.02|TWO_SIDED|95.0|1.09|2.6|||Regression, Cox|||The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models||2.60|1.09|0.02
91589698|NCT02973425|183069379|OTHER||Linear regression|0.03||||0.03|TWO_SIDED|95.0|||||Regression, Linear|||For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.||||0.03
91589699|NCT02973425|183069380|OTHER|Six-month OR, 95%CI, and P value were calculated from generalized estimating equation marginal models with a logit link and an exchangeable correlation matrix.|Odds Ratio (OR)|1.92||||0.048|TWO_SIDED|95.0|1.01|3.68||Analysis models were adjusted by study site, having quit attempts in the past 12 months measured at baseline, cigarettes per day measured at baseline, quit attempts in the past 12 months measured at baseline.|Chi-squared|||||3.68|1.01|0.048
91589700|NCT02973425|183069381|OTHER||Odds Ratio (OR)|2.01||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).||||0.01
91589701|NCT03823404|183069387|SUPERIORITY||||||<|0.0455||||||The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.|mixed-effects model for repeated measure|||||||<0.0455
91589702|NCT03823404|183069388|SUPERIORITY||||||<|455|||||||Mixed Models Analysis|||||||<0455
91589703|NCT03829241|183069417|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.7||0.917|TWO_SIDED|95.0|-1.45|1.3|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||1.30|-1.45|0.917
91589704|NCT00698451|183069423|SUPERIORITY_OR_OTHER||Percentage|72.2||||0.05|TWO_SIDED|95.0|58.4|83.5|||Exact Binomial Distribution|||||83.5|58.4|0.05
91781839|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-0.199|||||TWO_SIDED|95.0|-2.58|2.18||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.18|-2.58|
91781840|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.34|4.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.07|-1.34|
91781841|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||||TWO_SIDED|95.0|0.674|6.69||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.69|0.674|
91781842|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-0.0178|4.81||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.81|-0.0178|
91589705|NCT05178134|183069429|NON_INFERIORITY|Non-inferiority margin was set to -15% (on an absolute scale)|Difference in response rates|-0.02|||||TWO_SIDED|95.0|-0.108|0.069||||||||0.069|-0.108|
91589706|NCT00006392|183069509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.01|TWO_SIDED|99.0|0.95|1.35||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.35|0.95|< .01
91589707|NCT00006392|183069509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.01|TWO_SIDED|99.0|0.87|1.24||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.24|0.87|< .01
91589708|NCT00006392|183069509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||<|0.01||99.0|0.88|1.25||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.||1.25|.88|< .01
91589709|NCT00006392|183069510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||>|0.05||99.0|0.64|1.55||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.55|.64|> .05
91589710|NCT00006392|183069510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||>|0.01|TWO_SIDED|99.0|0.73|1.72||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.72|0.73|> .01
91589711|NCT00006392|183069510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||>|0.01|TWO_SIDED|99.0|0.9|1.16||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.16|0.90|>.01
91589712|NCT00006392|183069511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||>|0.05|TWO_SIDED|99.0|0.69|1.73||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.73|0.69|> .05
91589713|NCT00006392|183069511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||>|0.05|TWO_SIDED|99.0|0.66|1.67||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.67|0.66|> .05
91589714|NCT00006392|183069511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||>|0.05|TWO_SIDED|99.0|0.82|2.0||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||2.00|0.82|> .05
91589715|NCT00006392|183069512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||>|0.05|TWO_SIDED|99.0|0.91|1.17||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.17|0.91|> .05
91589716|NCT00006392|183069512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||>|0.05|TWO_SIDED|99.0|0.89|1.15||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.15|0.89|> .05
91589717|NCT00006392|183069512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||>|0.05||99.0|0.9|1.16||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.16|0.90|> .05
91589718|NCT00006392|183069513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||>|0.05||99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo is the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
91589719|NCT00006392|183069513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||>|0.05|TWO_SIDED|99.0|0.82|1.19||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.19|0.82|> .05
91589720|NCT00006392|183069513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||>|0.05|TWO_SIDED|99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox|||Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
91781843|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-4.22|||||TWO_SIDED|95.0|-7.83|-0.619||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-0.619|-7.83|
91781844|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|0.335|||||TWO_SIDED|95.0|-4.45|5.12||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.12|-4.45|
91589721|NCT00006392|183069514|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||>|0.05|TWO_SIDED|99.0|0.88|1.09||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.09|0.88|> .05
91589722|NCT00006392|183069514|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||>|0.05|TWO_SIDED|99.0|0.92|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.13|0.92|> .05
91589723|NCT00006392|183069514|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED|99.0|0.89|1.1||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.10|0.89|> .05
91589724|NCT01186796|183069519|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91589725|NCT01186796|183069520|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
91589726|NCT01186796|183069521|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||"Unit of mass secreted per burst is in ug/L. An automated deconvolution method was used and mathematically verified by direct statistical proof and empirically validated using hypothalamopituitary sampling and a simulated pulsatile time series."|ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
91589727|NCT01186796|183069522|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
91589728|NCT01186796|183069523|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
91589729|NCT01936909|183069538|SUPERIORITY||||||>|0.2|||||||ANOVA|||This test reflects a comparison between baseline and 2 weeks (both rows).||||>0.20
91589730|NCT01936909|183069539|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Paired analysis versus baseline||||<0.01
91589731|NCT01936909|183069540|SUPERIORITY|Log-rank test||||||0.12|||||||Log Rank|||||||0.12
91589732|NCT00578786|183069543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0|STANDARD_DEVIATION|74.28|||TWO_SIDED|95.0|22.7|53.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||53.3|22.7|
91589733|NCT00578786|183069543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.5|STANDARD_DEVIATION|78.55|||TWO_SIDED|95.0|21.1|43.8|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||43.8|21.1|
91589734|NCT00578786|183069543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.9|STANDARD_DEVIATION|72.85|||TWO_SIDED|95.0|26.1|55.7|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||55.7|26.1|
91589735|NCT00578786|183069543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.0|STANDARD_DEVIATION|75.97|||TWO_SIDED|95.0|28.3|43.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||43.7|28.3|
91589736|NCT00578786|183069544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|96.14|||TWO_SIDED|95.0|5.1|44.7|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||44.7|5.1|
91589737|NCT00578786|183069544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.9|STANDARD_DEVIATION|94.5|||TWO_SIDED|95.0|14.2|41.6|||||Applies to Ambrisentan 5.0 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||41.6|14.2|
91589738|NCT00578786|183069544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.2|STANDARD_DEVIATION|72.97|||TWO_SIDED|95.0|22.4|52.0|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||52.0|22.4|
91589739|NCT00578786|183069544|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.5|STANDARD_DEVIATION|89.81|||TWO_SIDED|95.0|20.4|38.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||38.7|20.4|
91589740|NCT00578786|183069545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|97.48|||TWO_SIDED|95.0|-13.4|26.8|||||Applies to Ambrisentan 2.5 mg group only. LOCF method of imputation.|||26.8|-13.4|
91589741|NCT00578786|183069545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_DEVIATION|100.69|||TWO_SIDED|95.0|8.7|37.8|||||Applies to Ambrisentan 5 mg group only. LOCF method of imputation.|||37.8|8.7|
91589742|NCT00578786|183069545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0|STANDARD_DEVIATION|84.38|||TWO_SIDED|95.0|10.9|45.1|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation.|||45.1|10.9|
91589743|NCT00578786|183069545|SUPERIORITY_OR_OTHER||Median Difference (Net)|20.3|STANDARD_DEVIATION|96.05|||TWO_SIDED|95.0|10.6|30.1|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||30.1|10.6|
91589744|NCT00578786|183069546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|95.21|||TWO_SIDED|95.0|-18.9|20.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||20.3|-18.9|
91589745|NCT00578786|183069546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.8|STANDARD_DEVIATION|101.22|||TWO_SIDED|95.0|4.2|33.5|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||33.5|4.2|
91589746|NCT00578786|183069546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.8|STANDARD_DEVIATION|87.07|||TWO_SIDED|95.0|10.1|45.4|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||45.4|10.1|
91589747|NCT00578786|183069546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.6|STANDARD_DEVIATION|96.54|||TWO_SIDED|95.0|6.8|26.4|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||26.4|6.8|
91589748|NCT00578786|183069548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|2.254|||TWO_SIDED|95.0|-0.55|0.38|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.38|-0.55|
91589749|NCT00578786|183069548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|-0.94|-0.23|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.23|-0.94|
91589750|NCT00578786|183069548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-1.0|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-1.00|
91589751|NCT00578786|183069548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|2.393|||TWO_SIDED|95.0|-0.69|-0.2|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.20|-0.69|
91589752|NCT00578786|183069549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|2.603|||TWO_SIDED|95.0|-0.31|0.76|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.76|-0.31|
91589753|NCT00578786|183069549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|2.477|||TWO_SIDED|95.0|-0.68|0.03|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.03|-0.68|
91589754|NCT00578786|183069549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|2.305|||TWO_SIDED|95.0|-1.12|-0.18|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.18|-1.12|
91589755|NCT00578786|183069549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_DEVIATION|2.48|||TWO_SIDED|95.0|-0.52|-0.02|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.02|-0.52|
91589756|NCT00578786|183069550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|2.593|||TWO_SIDED|95.0|-0.33|0.74|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.74|-0.33|
91589757|NCT00578786|183069550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.514|||TWO_SIDED|95.0|-0.51|0.22|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.22|-0.51|
91589758|NCT00578786|183069550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|2.215|||TWO_SIDED|95.0|-0.93|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-0.93|
91589759|NCT00578786|183069550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.467|||TWO_SIDED|95.0|-0.39|0.11|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.11|-0.39|
91589760|NCT00312221|183069563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.126|TWO_SIDED|95.0|-0.8562|0.1054|||Mixed Models Analysis||Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase|||0.1054|-0.8562|0.126
91589761|NCT00312221|183069563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.14||95.0|-0.8455|0.1189|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.1189|-0.8455|0.140
91589762|NCT00312221|183069564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.47|-0.2|||ANCOVA||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||-0.20|-1.47|0.007
91589763|NCT00312221|183069564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.011|TWO_SIDED|95.0|-1.47|-0.17|||ANCOVA||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||-0.17|-1.47|0.011
91589764|NCT00312221|183069565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.707|TWO_SIDED|95.0|-3.0054|2.0397|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||2.0397|-3.0054|0.707
91589765|NCT00312221|183069565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.187|TWO_SIDED|95.0|-4.4459|0.8706|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.8706|-4.4459|0.187
91589766|NCT00312221|183069566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.685|TWO_SIDED|95.0|-5.6177|3.693|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||3.6930|-5.6177|0.685
91589767|NCT00312221|183069566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.443|TWO_SIDED|95.0|-6.4415|2.8255|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||2.8255|-6.4415|0.443
91589768|NCT01807923|183069572|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.03|||<|0.0001|TWO_SIDED|95.0|2.62|5.44|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than (\<)18 versus greater than equal to (\>=18) years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||5.44|2.62|<0.0001
91589769|NCT01807923|183069572|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0003|TWO_SIDED|95.0|1.18|4.01|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.01|1.18|0.0003
91589770|NCT01807923|183069573|SUPERIORITY_OR_OTHER||LS Mean Difference|6.73|||<|0.0001|TWO_SIDED|95.0|4.27|9.19|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||9.19|4.27|<0.0001
91589771|NCT01807923|183069573|SUPERIORITY_OR_OTHER||LS Mean Difference|4.33||||0.0006|TWO_SIDED|95.0|1.86|6.8|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||6.80|1.86|0.0006
91589772|NCT01807923|183069574|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.1122|TWO_SIDED|95.0|-0.04|0.35|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.35|-0.04|0.1122
91589773|NCT01807923|183069574|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1938|TWO_SIDED|95.0|-0.07|0.32|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.32|-0.07|0.1938
91589774|NCT01807923|183069575|SUPERIORITY_OR_OTHER||LS Mean Difference|3.88||||0.0168|TWO_SIDED|95.0|0.7|7.05||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||7.05|0.70|0.0168
91589775|NCT01807923|183069575|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.3569|TWO_SIDED|95.0|-1.69|4.69|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.69|-1.69|0.3569
91589776|NCT01807923|183069576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9378|||<|0.0001|TWO_SIDED|95.0|1.8786|4.5941||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.5941|1.8786|<0.0001
91589777|NCT01807923|183069576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0592||||0.0023|TWO_SIDED|95.0|1.292|3.2819||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.2819|1.2920|0.0023
91589778|NCT01807923|183069577|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.7186||||0.0491|TWO_SIDED|95.0|0.517|0.9987|||Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9987|0.5170|0.0491
91589779|NCT01807923|183069577|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6643||||0.0169|TWO_SIDED|95.0|0.4749|0.9291||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.9291|0.4749|0.0169
91589780|NCT01807923|183069578|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1565|TWO_SIDED|95.0|-0.16|0.96|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||0.96|-0.16|0.1565
91589781|NCT01807923|183069578|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2992|TWO_SIDED|95.0|-0.26|0.86|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.86|-0.26|0.2992
91589782|NCT01807923|183069579|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.1539|TWO_SIDED|95.0|-0.037|0.233|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.2330|-0.0370|0.1539
91589783|NCT01807923|183069579|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0781||||0.2713|TWO_SIDED|95.0|-0.0615|0.2176|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.2176|-0.0615|0.2713
91589784|NCT01807923|183069580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0396|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0396
91589785|NCT01807923|183069580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.0385|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0385
91589786|NCT01807923|183069581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6565||||0.0552|TWO_SIDED|95.0|0.4266|1.0103|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||1.0103|0.4266|0.0552
91589787|NCT01807923|183069581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6438||||0.0512|TWO_SIDED|95.0|0.4142|1.0005|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||1.0005|0.4142|0.0512
91589788|NCT01807923|183069582|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.5604|TWO_SIDED|95.0|-0.0142|0.0262|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0262|-0.0142|0.5604
91589789|NCT01807923|183069582|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0095||||0.3613|TWO_SIDED|95.0|-0.0109|0.0298|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0298|-0.0109|0.3613
91589790|NCT01807923|183069583|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.1342|TWO_SIDED|95.0|-0.7|4.9|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||4.9|-0.7|0.1342
91589791|NCT01807923|183069583|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.3071|TWO_SIDED|95.0|-1.3|4.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||4.2|-1.3|0.3071
91589792|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.016|TWO_SIDED|95.0|1.03|9.96|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||9.96|1.03|0.0160
91589793|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.0126|TWO_SIDED|95.0|1.25|10.35|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||10.35|1.25|0.0126
91709108|NCT03035916|183311327|OTHER|||||||0.555|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
91589794|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.18||||0.0074|TWO_SIDED|95.0|-7.23|-1.13|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-1.13|-7.23|0.0074
91589795|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.74||||0.0029|TWO_SIDED|95.0|-7.85|-1.63|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.63|-7.85|0.0029
91589796|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.7721|TWO_SIDED|95.0|-3.5|4.71|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.71|-3.50|0.7721
91589797|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.1472|TWO_SIDED|95.0|-1.09|7.25|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||7.25|-1.09|0.1472
91589798|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.0345|TWO_SIDED|95.0|0.4|10.58|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||10.58|0.40|0.0345
91589799|NCT01807923|183069584|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.0109|TWO_SIDED|95.0|1.55|11.89|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||11.89|1.55|0.0109
91589800|NCT04721821|183069590|SUPERIORITY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.82|1.44||||||||1.44|0.82|
91589801|NCT04721821|183069591|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.44|1.16||||||||1.16|0.44|
91589802|NCT04721821|183069592|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.73|1.27||||||||1.27|0.73|
91589803|NCT04721821|183069593|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.79|1.88||||||||1.88|0.79|
91589804|NCT04721821|183069594|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.79|1.67||||||||1.67|0.79|
91589805|NCT04721821|183069595|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.94|1.76||||||||1.76|0.94|
91589806|NCT04721821|183069596|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.7|1.89||||||||1.89|0.70|
91589807|NCT04721821|183069597|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.69|1.32||||||||1.32|0.69|
91709109|NCT03035916|183311327|OTHER|||||||0.411|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.411
91589808|NCT04721821|183069598|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.81|2.16||||||||2.16|0.81|
91589809|NCT04721821|183069599|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.81|1.87||||||||1.87|0.81|
91589810|NCT04721821|183069600|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.8|1.66||||||Month 6 follow-up visit analysis||1.66|0.80|
91589811|NCT04721821|183069600|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||Month 12 follow-up visit analysis||1.65|0.75|
91589812|NCT04721821|183069601|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.57|1.99||||||Month 6 follow-up visit analysis||1.99|0.57|
91589813|NCT04721821|183069601|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.49|1.75||||||Month 12 follow-up visit analysis||1.75|0.49|
91589814|NCT04721821|183069602|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.79|1.58||||||Month 6 follow-up visit analysis||1.58|0.79|
91589815|NCT04721821|183069602|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35||||||Month 12 follow-up visit analysis||1.35|0.60|
91589816|NCT04721821|183069603|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.77|2.29||||||Month 6 follow-up visit analysis||2.29|0.77|
91589817|NCT04721821|183069603|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.82|2.71||||||Month 12 follow-up visit analysis||2.71|0.82|
91589818|NCT04721821|183069604|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.81|2.24||||||Month 6 follow-up visit analysis||2.24|0.81|
91589819|NCT04721821|183069604|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.62||||||Month 12 follow-up visit analysis||1.62|0.50|
91589820|NCT04721821|183069605|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.88|1.31||||||Month 6 follow-up visit analysis||1.31|-0.88|
91589821|NCT04721821|183069605|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.73|-0.27||||||Month 12 follow-up visit analysis||-0.27|-2.73|
91589822|NCT04721821|183069606|SUPERIORITY||Median Difference (Net)|0.39|||||TWO_SIDED|95.0|-1.24|2.02||||||Month 6 follow-up visit analysis||2.02|-1.24|
91589823|NCT04721821|183069606|SUPERIORITY||Median Difference (Net)|0.96|||||TWO_SIDED|95.0|-0.92|2.84||||||Month 12 follow-up visit analysis||2.84|-0.92|
91589824|NCT04721821|183069607|SUPERIORITY||Mean Difference (Net)|-0.56|||||TWO_SIDED|95.0|-1.68|0.56||||||Month 6 follow-up visit analysis||0.56|-1.68|
91589825|NCT04721821|183069607|SUPERIORITY||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-0.51|1.99||||||Month 12 follow-up visit analysis||1.99|-0.51|
91589826|NCT04721821|183069608|SUPERIORITY||Mean Difference (Net)|-1.11|||||TWO_SIDED|95.0|-2.66|0.45||||||Month 6 follow-up visit analysis||0.45|-2.66|
91589827|NCT04721821|183069608|SUPERIORITY||Mean Difference (Net)|-1.73|||||TWO_SIDED|95.0|-3.52|0.05||||||Month 12 follow-up visit analysis||0.05|-3.52|
91589828|NCT04721821|183069609|SUPERIORITY||Mean Difference (Net)|-0.93|||||TWO_SIDED|95.0|-2.3|0.44||||||Month 6 follow-up visit analysis||0.44|-2.30|
91589829|NCT04721821|183069609|SUPERIORITY||Mean Difference (Net)|-0.99|||||TWO_SIDED|95.0|-2.6|0.62||||||Month 12 follow-up visit analysis||0.62|-2.60|
91589830|NCT04721821|183069610|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||Month 6 follow-up visit analysis: mACR 20||1.35|0.80|
91781845|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-4.81|0.969||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.969|-4.81|
91781846|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||||TWO_SIDED|95.0|-1.15|6.1||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.10|-1.15|
91589831|NCT04721821|183069610|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.86|1.67||||||Month 6 follow-up visit analysis: mACR 50||1.67|0.86|
91589832|NCT04721821|183069610|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.57|1.54||||||Month 6 follow-up visit analysis: mACR 70||1.54|0.57|
91589833|NCT04721821|183069610|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||Month 12 follow-up visit analysis: mACR 20||1.41|0.77|
91589834|NCT04721821|183069610|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.89|1.95||||||Month 12 follow-up visit analysis: mACR 50||1.95|0.89|
91589835|NCT04721821|183069610|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.85|2.6||||||Month 12 follow-up visit analysis: mACR 70||2.60|0.85|
91589836|NCT04721821|183069611|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.34||||||Month 6 follow-up visit analysis: mACR 20||1.34|0.59|
91589837|NCT04721821|183069611|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.39|1.15||||||Month 6 follow-up visit analysis: mACR 50||1.15|0.39|
91589838|NCT04721821|183069611|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.34|1.83||||||Month 6 follow-up visit analysis: mACR 70||1.83|0.34|
91589839|NCT04721821|183069611|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.42||||||Month 12 follow-up visit analysis: mACR 20||1.42|0.56|
91589840|NCT04721821|183069611|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.46|1.8||||||Month 12 follow-up visit analysis: mACR 50||1.80|0.46|
91589841|NCT04721821|183069611|SUPERIORITY||Odds Ratio (OR)|0.54|||||TWO_SIDED|95.0|0.19|1.48||||||Month 12 follow-up visit analysis: mACR 70||1.48|0.19|
91589842|NCT04721821|183069612|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.45||||||Month 6 follow-up visit analysis: mACR 20||1.45|0.86|
91589843|NCT04721821|183069612|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.67|1.26||||||Month 6 follow-up visit analysis: mACR 50||1.26|0.67|
91781847|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|9.12|||||TWO_SIDED|95.0|4.3|13.9||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.9|4.30|
91589844|NCT04721821|183069612|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.44|1.09||||||Month 6 follow-up visit analysis: mACR 70||1.09|0.44|
91589845|NCT04721821|183069612|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.74|1.38||||||Month 12 follow-up visit analysis: mACR 20||1.38|0.74|
91589846|NCT04721821|183069612|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.69|1.52||||||Month 12 follow-up visit analysis: mACR 50||1.52|0.69|
91589847|NCT04721821|183069612|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.46|1.33||||||Month 12 follow-up visit analysis: mACR 70||1.33|0.46|
91589848|NCT04721821|183069613|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.78|1.77||||||Month 6 follow-up visit analysis: mACR 20||1.77|0.78|
91589849|NCT04721821|183069613|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.71|1.95||||||Month 6 follow-up visit analysis: mACR 50||1.95|0.71|
91589850|NCT04721821|183069613|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.39||||||Month 6 follow-up visit analysis: mACR 70||2.39|0.45|
91589851|NCT04721821|183069613|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.5|1.4||||||Month 12 follow-up visit analysis: mACR 20||1.40|0.50|
91589852|NCT04721821|183069613|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.49|1.83||||||Month 12 follow-up visit analysis: mACR 50||1.83|0.49|
91589853|NCT04721821|183069613|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.33|1.95||||||Month 12 follow-up visit analysis: mACR 70||1.95|0.33|
91589854|NCT04721821|183069614|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.76|1.49||||||Month 6 follow-up visit analysis: mACR 20||1.49|0.76|
91589855|NCT04721821|183069614|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||Month 6 follow-up visit analysis: mACR 50||1.37|0.55|
91589856|NCT04721821|183069614|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.32|1.2||||||Month 6 follow-up visit analysis: mACR 70||1.20|0.32|
91589857|NCT04721821|183069614|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||Month 12 follow-up visit analysis: mACR 20||1.30|0.59|
91589858|NCT04721821|183069614|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.65|1.86||||||Month 12 follow-up visit analysis: mACR 50||1.86|0.65|
91589859|NCT04721821|183069614|SUPERIORITY||Odds Ratio (OR)|1.43||||||95.0|0.62|3.28||||||Month 12 follow-up visit analysis: mACR 70||3.28|0.62|
91589860|NCT04721821|183069615|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.94|2.15||||||Month 6 follow-up visit analysis||2.15|0.94|
91589861|NCT04721821|183069615|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.68|1.84||||||Month 12 follow-up visit analysis||1.84|0.68|
91781848|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|6.03|||||TWO_SIDED|95.0|3.12|8.94||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.94|3.12|
91781849|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-0.913|||||TWO_SIDED|95.0|-4.65|2.82||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.82|-4.65|
91781850|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-0.444|||||TWO_SIDED|95.0|-4.33|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.44|-4.33|
91589862|NCT04721821|183069616|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.41|1.67||||||Month 6 follow-up visit analysis||1.67|0.41|
91589863|NCT04721821|183069616|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.62|3.07||||||Month 12 follow-up visit analysis||3.07|0.62|
91589864|NCT04721821|183069617|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Month 6 follow-up visit analysis||1.52|0.66|
91589865|NCT04721821|183069617|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.64|1.74||||||Month 12 follow-up visit analysis||1.74|0.64|
91589866|NCT04721821|183069618|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.8|2.94||||||Month 6 follow-up visit analysis||2.94|0.80|
91589867|NCT04721821|183069618|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.76|3.87||||||Month 12 follow-up visit analysis||3.87|0.76|
91589868|NCT04721821|183069619|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.73|2.27||||||Month 6 follow-up visit analysis||2.27|0.73|
91589869|NCT04721821|183069619|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.63|2.23||||||Month 12 follow-up visit analysis||2.23|0.63|
91648114|NCT01864525|183188765|SUPERIORITY|||||||0.7172||||||A priori significance was set at P\<0.05 for this hypothesis-driven auditory-perceptual variable. Main effect for drug is given above. For the main task effect, P=0.9602. For the interaction effect of drug\*task, P=0.1699.|Mixed Models Analysis|||Statistical modeling tested for main effects of auditory-perceptual ratings for drug and task (sustained vowel and sentence-level ratings), and interaction effects of these variables. The summed scores, averaged across all participants, are provided separately for the sustained vowel and sentence-level ratings. Values range from 0 (no difference between baseline and post-test) to 3 (all three raters indicated that post-test sample was better (less tremor severity).||||0.7172
91648115|NCT01890785|183188766|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.708|||||TWO_SIDED|90.0|0.655|0.766||||||||0.766|0.655|
91589870|NCT04721821|183069620|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
91589871|NCT04721821|183069620|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||Month 12 follow-up visit analysis||0.09|-0.01|
91589872|NCT04721821|183069621|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06||||||Month 6 follow-up visit analysis||0.06|-0.08|
91589873|NCT04721821|183069621|SUPERIORITY||Median Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.05||||||Month 12 follow-up visit analysis||0.05|-0.11|
91589874|NCT04721821|183069622|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||Month 6 follow-up visit analysis||0.03|-0.07|
91589875|NCT04721821|183069622|SUPERIORITY||Odds Ratio (OR)|0.01|||||TWO_SIDED|95.0|-0.05|0.07||||||Month 12 follow-up visit analysis||0.07|-0.05|
91589876|NCT04721821|183069623|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||Month 6 follow-up visit analysis||0.07|-0.06|
91589877|NCT04721821|183069623|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.12|0.06||||||Month 12 follow-up visit analysis||0.06|-0.12|
91589878|NCT04721821|183069624|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04||||||Month 6 follow-up visit analysis||0.04|-0.09|
91589879|NCT04721821|183069624|SUPERIORITY||Odds Ratio (OR)|0.02|||||TWO_SIDED|95.0|-0.06|0.09||||||Month 12 follow-up visit analysis||0.09|-0.06|
91589880|NCT04721821|183069625|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.9|1.45||||||Month 6 follow-up visit analysis||1.45|0.90|
91589881|NCT04721821|183069625|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.54|0.94||||||Month 12 follow-up visit analysis||0.94|0.54|
91589882|NCT04721821|183069626|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.53|1.11||||||Month 6 follow-up visit analysis||1.11|0.53|
91589883|NCT04721821|183069626|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.72|1.61||||||Month 12 follow-up visit analysis||1.61|0.72|
91589884|NCT04721821|183069627|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.73|1.21||||||Month 6 follow-up visit analysis||1.21|0.73|
91589885|NCT04721821|183069627|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.39||||||Month 12 follow-up visit analysis||1.39|0.77|
91589886|NCT04721821|183069628|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||Month 6 follow-up visit analysis||1.32|0.64|
91589887|NCT04721821|183069628|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.69|1.64||||||Month 12 follow-up visit analysis||1.64|0.69|
91589888|NCT04721821|183069629|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.59||||||Month 6 follow-up visit analysis||1.59|0.84|
91589889|NCT04721821|183069629|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||Month 12 follow-up visit analysis||1.32|0.65|
91589890|NCT04721821|183069630|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.04||||||Month 6 follow-up visit analysis||0.04|-0.03|
91589891|NCT04721821|183069630|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.04|0.05||||||Month 12 follow-up visit analysis||0.05|-0.04|
91589892|NCT04721821|183069631|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.05|0.05||||||Month 6 follow-up visit analysis||0.05|-0.05|
91589893|NCT04721821|183069631|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.07|0.06||||||Month 12 follow-up visit analysis||0.06|-0.07|
91589894|NCT04721821|183069632|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.02||||||Month 6 follow-up visit analysis||0.02|-0.06|
91589895|NCT04721821|183069632|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||Month 12 follow-up visit analysis||0.04|-0.04|
91589896|NCT04721821|183069633|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
91589897|NCT04721821|183069633|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.1|0.03||||||Month 12 follow-up visit analysis||0.03|-0.10|
91589898|NCT04721821|183069634|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.05|0.04||||||Month 6 follow-up visit analysis||0.04|-0.05|
91589899|NCT04721821|183069634|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.06||||||Month 12 follow-up visit analysis||0.06|-0.06|
91589900|NCT04721821|183069635|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.65|2.45||||||Month 6 follow-up visit analysis||2.45|-2.65|
91781851|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|0.378|||||TWO_SIDED|95.0|-2.2|2.95||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.95|-2.20|
91589901|NCT04721821|183069635|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-2.59|3.11||||||Month 12 follow-up visit analysis||3.11|-2.59|
91589902|NCT04721821|183069636|SUPERIORITY||Mean Difference (Final Values)|0.83|||||TWO_SIDED|95.0|-2.71|4.38||||||Month 6 follow-up visit analysis||4.38|-2.71|
91589903|NCT04721821|183069636|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-5.12|2.95||||||Month 12 follow-up visit analysis||2.95|-5.12|
91589904|NCT04721821|183069637|SUPERIORITY||Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-3.94|1.45||||||Month 6 follow-up visit analysis||1.45|-3.94|
91589905|NCT04721821|183069637|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-3.61|2.42||||||Month 12 follow-up visit analysis||2.42|-3.61|
91781852|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|0.878|||||TWO_SIDED|95.0|-2.86|4.62||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.62|-2.86|
91589906|NCT04721821|183069638|SUPERIORITY||Mean Difference (Final Values)|-0.67|||||TWO_SIDED|95.0|-4.39|3.05||||||Month 6 follow-up visit analysis||3.05|-4.39|
91589907|NCT04721821|183069638|SUPERIORITY||Mean Difference (Final Values)|-4.84|||||TWO_SIDED|95.0|-9.19|-0.48||||||Month 12 follow-up visit analysis||-0.48|-9.19|
91589908|NCT04721821|183069639|SUPERIORITY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-3.59|2.82||||||Month 6 follow-up visit analysis||2.82|-3.59|
91589909|NCT04721821|183069639|SUPERIORITY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.97|4.49||||||Month 12 follow-up visit analysis||4.49|-2.97|
91781853|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|2.92|||||TWO_SIDED|95.0|-0.966|6.8||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.80|-0.966|
91589910|NCT04721821|183069640|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||Month 6 follow-up visit analysis||1.34|0.73|
91589911|NCT04721821|183069640|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.66|1.34||||||Month 12 follow-up visit analysis||1.34|0.66|
91589912|NCT04721821|183069641|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.62|1.73||||||Month 6 follow-up visit analysis||1.73|0.62|
91589913|NCT04721821|183069641|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.6||||||Month 12 follow-up visit analysis||1.60|0.50|
91589914|NCT04721821|183069642|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.64|1.19||||||Month 6 follow-up visit analysis||1.19|0.64|
91589915|NCT04721821|183069642|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.6|1.26||||||Month 12 follow-up visit analysis||1.26|0.60|
91589916|NCT04721821|183069643|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.55|1.46||||||Month 6 follow-up visit analysis||1.46|0.55|
91589917|NCT04721821|183069643|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.47|1.51||||||Month 12 follow-up visit analysis||1.51|0.47|
91589918|NCT04721821|183069644|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.6|1.38||||||Month 6 follow-up visit analysis||1.38|0.60|
91589919|NCT04721821|183069644|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.56|1.5||||||Month 12 follow-up visit analysis||1.50|0.56|
91589920|NCT04721821|183069645|SUPERIORITY||Mean Difference (Final Values)|1.71|||||TWO_SIDED|95.0|-0.69|4.11||||||Month 6 follow-up visit analysis||4.11|-0.69|
91589921|NCT04721821|183069645|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-2.79|2.77||||||Month 12 follow-up visit analysis||2.77|-2.79|
91648116|NCT01890785|183188766|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.918|||||TWO_SIDED|90.0|0.849|0.992||||||||0.992|0.849|
91589922|NCT04721821|183069646|SUPERIORITY||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-5.02|1.6||||||Month 6 follow-up visit analysis||1.60|-5.02|
91589923|NCT04721821|183069646|SUPERIORITY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-2.85|4.96||||||Month 12 follow-up visit analysis||4.96|-2.85|
91589924|NCT04721821|183069647|SUPERIORITY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-3.75|1.45||||||Month 6 follow-up visit analysis||1.45|-3.75|
91589925|NCT04721821|183069647|SUPERIORITY||Median Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-3.54|2.47||||||Month 12 follow-up visit analysis||2.47|-3.54|
91589926|NCT04721821|183069648|SUPERIORITY||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-2.36|4.73||||||Month 6 follow-up visit analysis||4.73|-2.36|
91589927|NCT04721821|183069648|SUPERIORITY||Mean Difference (Final Values)|-3.15|||||TWO_SIDED|95.0|-7.36|1.07||||||Month 12 follow-up visit analysis||1.07|-7.36|
91589928|NCT04721821|183069649|SUPERIORITY||Mean Difference (Final Values)|2.37|||||TWO_SIDED|95.0|-0.66|5.41||||||Month 6 follow-up visit analysis||5.41|-0.66|
91589929|NCT04721821|183069649|SUPERIORITY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-2.69|4.71||||||Month 12 follow-up visit analysis||4.71|-2.69|
91589930|NCT04721821|183069650|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.16|0.4||||||Month 6 follow-up visit analysis||0.40|-0.16|
91589931|NCT04721821|183069650|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.21|0.45||||||Month 12 follow-up visit analysis||0.45|-0.21|
91589932|NCT04721821|183069651|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.4|0.43||||||Month 6 follow-up visit analysis||0.43|-0.40|
91589933|NCT04721821|183069651|SUPERIORITY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.74|0.29||||||Month 12 follow-up visit analysis||0.29|-0.74|
91589934|NCT04721821|183069652|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.51|0.1||||||Month 6 follow-up visit analysis||0.10|-0.51|
91589935|NCT04721821|183069652|SUPERIORITY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.42|0.31||||||Month 12 follow-up visit analysis||0.31|-0.42|
91648117|NCT01890785|183188767|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.641|||||TWO_SIDED|90.0|0.582|0.707||||||||0.707|0.582|
91648118|NCT01890785|183188767|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.828|||||TWO_SIDED|90.0|0.752|0.912||||||||0.912|0.752|
91589936|NCT04721821|183069653|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.34|0.32||||||Month 6 follow-up visit analysis||0.32|-0.34|
91589937|NCT04721821|183069653|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.69|0.31||||||Month 12 follow-up visit analysis||0.31|-0.69|
91589938|NCT04721821|183069654|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.37|0.32||||||Month 6 follow-up visit analysis||0.32|-0.37|
91589939|NCT04721821|183069654|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.3|0.59||||||Month 12 follow-up visit analysis||0.59|-0.30|
91589940|NCT03836807|183069661|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.020
91589941|NCT03836807|183069662|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
91589942|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-0.3||||0.914|TWO_SIDED|95.0|-5.5|5.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at Baseline (at 0')||5.0|-5.5|0.914
91589943|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||7.4|-4.9|0.685
91589944|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-0.3||||0.93|TWO_SIDED|95.0|-7.4|6.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||6.8|-7.4|0.930
91589945|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-2.1||||0.615|TWO_SIDED|95.0|-10.3|6.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||6.1|-10.3|0.615
91589946|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-8.5||||0.051|TWO_SIDED|95.0|-17.0|0.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||0|-17.0|0.051
91589947|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-8.4||||0.043|TWO_SIDED|95.0|-16.6|-0.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||-0.3|-16.6|0.043
91589948|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-9.0||||0.023|TWO_SIDED|95.0|-16.7|-1.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||-1.3|-16.7|0.023
91589949|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-10.5||||0.009|TWO_SIDED|95.0|-18.2|-2.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||-2.7|-18.2|0.009
91589950|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-9.3||||0.018|TWO_SIDED|95.0|-17.0|-1.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||-1.7|-17.0|0.018
91589951|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-5.5||||0.182|TWO_SIDED|95.0|-13.6|2.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||2.6|-13.6|0.182
91589952|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-4.8||||0.236|TWO_SIDED|95.0|-12.9|3.2|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 4h||3.2|-12.9|0.236
91589953|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-3.6||||0.32|TWO_SIDED|95.0|-10.6|3.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5h||3.5|-10.6|0.320
91589954|NCT03836807|183069663|SUPERIORITY||adjusted least square mean|-2.2||||0.572|TWO_SIDED|95.0|-10.0|5.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||5.6|-10.0|0.572
91589955|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|2.7||||0.361|TWO_SIDED|95.0|-3.1|8.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||8.4|-3.1|0.361
91589956|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|4.2||||0.298|TWO_SIDED|95.0|-3.8|12.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||12.3|-3.8|0.298
91589957|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|8.9||||0.112|TWO_SIDED|95.0|-2.1|19.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||19.8|-2.1|0.112
91589958|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.8|36.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||36.8|7.8|0.003
91589959|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|21.2||||0.008|TWO_SIDED|95.0|5.6|36.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||36.7|5.6|0.008
91589960|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|18.7||||0.018|TWO_SIDED|95.0|3.3|34.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||34.0|3.3|0.018
91589961|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.7|37.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||37.0|7.7|0.003
91589962|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|22.0||||0.003|TWO_SIDED|95.0|8.0|36.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||36.1|8.0|0.003
91589963|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|16.7||||0.015|TWO_SIDED|95.0|3.4|30.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||30.0|3.4|0.015
91589964|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|10.8||||0.103|TWO_SIDED|95.0|-2.2|23.9|||ANOVA|||at 4h||23.9|-2.2|0.103
91589965|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|5.9||||0.311|TWO_SIDED|95.0|-5.6|17.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||17.5|-5.6|0.311
91589966|NCT03836807|183069664|SUPERIORITY||adjusted least square mean|2.8||||0.638|TWO_SIDED|95.0|-9.0|14.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||14.5|-9.0|0.638
91589967|NCT03836807|183069665|SUPERIORITY|||||||0.007|||||||ANOVA|||in the ITT population||||0.007
91781854|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|2.94|||||TWO_SIDED|95.0|0.366|5.52||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|0.366|
91781855|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-2.88|||||TWO_SIDED|95.0|-6.84|1.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.07|-6.84|
91781856|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-0.975|||||TWO_SIDED|95.0|-5.39|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.44|-5.39|
91781857|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-1.82|||||TWO_SIDED|95.0|-5.3|1.66||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.66|-5.30|
91781858|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|5.6|||||TWO_SIDED|95.0|1.63|9.56||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.56|1.63|
91781859|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|7.82|||||TWO_SIDED|95.0|3.39|12.3||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.3|3.39|
91781860|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|6.6|||||TWO_SIDED|95.0|3.11|10.1||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.1|3.11|
91781861|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|0.847|||||TWO_SIDED|95.0|-3.23|4.92||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.92|-3.23|
91781862|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-3.48|||||TWO_SIDED|95.0|-8.17|1.21||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.21|-8.17|
91781863|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-0.372|||||TWO_SIDED|95.0|-2.88|2.14||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.14|-2.88|
91781864|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|-2.17|5.98||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.98|-2.17|
91781865|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-3.62|5.76||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.76|-3.62|
91781866|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|3.03|||||TWO_SIDED|95.0|0.522|5.55||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.55|0.522|
91781867|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|0.737|||||TWO_SIDED|95.0|-3.9|5.38||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.38|-3.90|
91781868|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-1.95|||||TWO_SIDED|95.0|-6.36|2.47||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.47|-6.36|
91781869|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-4.79|2.45||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.45|-4.79|
91781870|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|7.25|||||TWO_SIDED|95.0|2.59|11.9||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.9|2.59|
91781871|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|5.58|||||TWO_SIDED|95.0|1.13|10.0||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.0|1.13|
91781872|NCT01263197|183442974|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||||TWO_SIDED|95.0|1.89|9.16||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.16|1.89|
91589968|NCT03836807|183069665|SUPERIORITY|||||||0.009|||||||ANOVA|||in the PP population||||0.009
91589969|NCT03836807|183069666|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
91589970|NCT03836807|183069667|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
91589971|NCT03836807|183069668|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.480
91589972|NCT03531788|183069674|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor provide data per participant during testing of upper extremity activities/tasks and were collected while wearing the device (Kinova and WREX) and without the device (Kinova and WREX). For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|Due to the small sample size, we utilized change in activity count data when comparing two upper limb testing sessions: one without the use of an arm support device (Kinova or WREX) and one while using the arm support device. For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|||
91589973|NCT03531788|183069675|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor were collected during baseline (without a device) and throughout the 4 week device trial (with the device). For each time period, activity count data were averaged across the day. We then compared the baseline time period to the device trial period to understand the difference in movement and upper extremity positioning during the device trial. Data presented are within group change scores and not between group data comparisons.|Counts from each axis (x, y, z) were measured across baseline and during the 4-week trial to explore arm movement and positioning during the use of an upper extremity arm device. Counts (within each participant) were summed. A change score from trial minus baseline was calculated for each axis. We provide an average change score and standard deviation across participants with Kinova and participants with WREX.|||
91589974|NCT03531788|183069676|OTHER|||||||||||||||||Three goals were identified for each participant and scored without using an arm support device to serve as a baseline measure of abilities. These scores were compared to the scores achieved on the same goals using the arm support device.|We compared the change in GAS scores when using an arm support device on three goal areas identified as important for each participant. For each goal, we measured abilities at baseline and with the device (Kinova and WREX). We calculated the change in score for each goal and averaged these change scores across all participants. While our groups are too small to complete statistical tests to estimate the significance of the differences participants noted in activity and independence while using both arm supports, our results quantify the amount of increased success participants noted with the use of the arm support device.|||
91589975|NCT02019420|183069677|NON_INFERIORITY|Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI \> -10.|Difference in all-cause mortality|-1.8|||||TWO_SIDED|95.0|-8.2|4.7|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||4.7|-8.2|
91589976|NCT02019420|183069678|OTHER|Difference in mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.6|||||TWO_SIDED|95.0|-10.3|7.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||7.1|-10.3|
91589977|NCT02019420|183069679|OTHER|Difference in ITT clinical success (tedizolid - linezolid)|Difference in clinical success|-7.6|||||TWO_SIDED|95.0|-14.7|-0.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-0.5|-14.7|
91589978|NCT02019420|183069680|OTHER|Difference in CE clinical success (tedizolid - linezolid)|Difference in clinical success|-6.5|||||TWO_SIDED|95.0|-15.1|2.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||2.1|-15.1|
91589979|NCT02019420|183069681|OTHER|Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.5|||||TWO_SIDED|95.0|-12.5|9.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||9.5|-12.5|
91589980|NCT02019420|183069682|OTHER|Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||18.9|-12.8|
91589981|NCT02019420|183069683|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
91589982|NCT02019420|183069684|OTHER|Difference in ME-1 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
91589983|NCT02019420|183069685|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-12.5|||||TWO_SIDED|95.0|-21.5|-3.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-3.5|-21.5|
91589984|NCT02019420|183069686|OTHER|Difference in ME-2 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.7|||||TWO_SIDED|95.0|-26.2|-1.2|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-1.2|-26.2|
91589985|NCT03739437|183069736|SUPERIORITY|||||||0.384|||||||Chi-squared|||||||0.384
91589986|NCT05118204|183069807|SUPERIORITY||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|1.346||1|TWO_SIDED|95.0|0.05|16.54|||Fisher Exact|||||16.540|0.050|1.00
91613579|NCT01899144|183121465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.7|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|14.13|33.23|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||33.23|14.13|<0.0001
91589987|NCT04409353|183069837|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.47||||0.4884|TWO_SIDED|95.0|-0.87|1.81||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.81|-0.87|0.4884
91589988|NCT04409353|183069837|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.16||||0.8095|TWO_SIDED|95.0|-1.12|1.43||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.43|-1.12|0.8095
91589989|NCT04409353|183069838|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.79||||0.3101|TWO_SIDED|95.0|-0.74|2.32||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.32|-0.74|0.3101
91589990|NCT04409353|183069838|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.42||||0.6328|TWO_SIDED|95.0|-2.13|1.3||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.30|-2.13|0.6328
91589991|NCT04409353|183069838|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.16||||0.126|TWO_SIDED|95.0|-0.33|2.64||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.64|-0.33|0.1260
91589992|NCT04409353|183069838|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.51||||0.515|TWO_SIDED|95.0|-2.05|1.03||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.03|-2.05|0.5150
91613922|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.275||||0.0021|TWO_SIDED|95.0|0.121|0.626|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.626|0.121|0.0021
91613923|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.962||||0.0064|TWO_SIDED|95.0|0.935|0.989|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.935|0.0064
91613924|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.391|||<|0.0001|TWO_SIDED|95.0|1.245|1.553|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.553|1.245|<0.0001
91781873|NCT02557139|183443011|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|< 0.001
91781874|NCT02557139|183443011|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Geometric Means (%)|100.0||||0.23|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|0.23
91589993|NCT04409353|183069839|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.43||||0.018|TWO_SIDED|95.0|0.25|2.61||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||2.61|0.25|.0180
91589994|NCT04409353|183069839|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.5742|TWO_SIDED|95.0|-1.48|0.82||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||0.82|-1.48|0.5742
91589995|NCT04409353|183069840|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.39||||0.7338|TWO_SIDED|95.0|-1.85|2.62||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- Anxiety score obtained at Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.62|-1.85|0.7338
91589996|NCT04409353|183069840|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.63||||0.5279|TWO_SIDED|95.0|-1.34|2.6||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.60|-1.34|0.5279
91589997|NCT04409353|183069841|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.19||||0.1833|TWO_SIDED|95.0|-0.56|2.94||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||2.94|-0.56|0.1833
91589998|NCT04409353|183069841|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.7006|TWO_SIDED|95.0|-2.04|1.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||1.37|-2.04|0.7006
91781875|NCT02557139|183443012|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 34.25%|125.00|80.00|<0.001
91781876|NCT02557139|183443012|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.16|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability;|125.00|80.00|0.16
91589999|NCT04409353|183069842|OTHER||Common Odds Ratio|0.76||||0.1913|TWO_SIDED|95.0|0.5|1.15||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.15|0.50|0.1913
91590000|NCT04409353|183069842|OTHER||Common Odds Ratio|0.83||||0.367|TWO_SIDED|95.0|0.55|1.24||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.24|0.55|0.3670
91590001|NCT04409353|183069843|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.83||||0.1619|TWO_SIDED|95.0|-1.98|0.33||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||0.33|-1.98|0.1619
91590002|NCT04409353|183069843|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.04||||0.9569|TWO_SIDED|95.0|-1.31|1.24||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||1.24|-1.31|0.9569
91613580|NCT01899144|183121465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|4.85||0.0107|TWO_SIDED|95.0|2.93|22.05|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||22.05|2.93|0.0107
91648119|NCT01890785|183188768|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.937|1.004||||||||1.004|0.937|
91648120|NCT01890785|183188768|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.944|||||TWO_SIDED|90.0|0.912|0.977||||||||0.977|0.912|
91648121|NCT01890785|183188769|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.945|0.998||||||||0.998|0.945|
91521378|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.267|TWO_SIDED|95.0|-19.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||67|-19|0.267
91648122|NCT01890785|183188769|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.944|0.997||||||||0.997|0.944|
91648123|NCT03001011|183188780|SUPERIORITY||Median difference (Renvela - Placebo)|-0.21|||<|0.0001|TWO_SIDED|||||Threshold for statistical significance at 0.05.|Wilcoxon rank sum test||Renvela Vs. Placebo|A hierarchical testing procedure was used to control type I error \& handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.||||<0.0001
91648124|NCT02392559|183188801|SUPERIORITY||treatment difference|-38.3|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.54|-31.06|||repeated measures model||Treatment difference uses placebo as the reference.|||-31.06|-45.54|< 0.0001
91590003|NCT04409353|183069844|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.03||||0.9727|TWO_SIDED|95.0|-1.8|1.86||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||1.86|-1.80|0.9727
91590004|NCT04409353|183069844|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.43||||0.6427|TWO_SIDED|95.0|-1.4|2.26||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||2.26|-1.40|0.6427
91590005|NCT04409353|183069845|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|691.58||||0.291|TWO_SIDED|95.0|-602.98|1986.14||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1986.14|-602.98|0.2910
91590006|NCT04409353|183069845|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|405.68||||0.4842|TWO_SIDED|95.0|-741.79|1553.15||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1553.15|-741.79|0.4842
91590007|NCT04409353|183069846|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.0||||0.4228|TWO_SIDED|95.0|-1.48|3.49||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||3.49|-1.48|0.4228
91613581|NCT01899144|183121465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.88||0.7772|TWO_SIDED|95.0|-11.0|8.23||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||8.23|-11.00|0.7772
91613582|NCT01899144|183121465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|4.87||0.0226|TWO_SIDED|95.0|-20.8|-1.59||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||-1.59|-20.80|0.0226
91613583|NCT01899144|183121466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
91781877|NCT02557139|183443012|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|< 0.001
91781878|NCT02557139|183443012|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.18|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided||Intra-subject variability = 38.16%|AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|0.18
91781879|NCT02284243|183443019|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.0180
91781880|NCT02284243|183443020|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, and SPID 0-24|ANCOVA|||||||<0.05
91648125|NCT02392559|183188801|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91648126|NCT02392559|183188802|SUPERIORITY||treatment difference|-42.09|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-48.34|-35.83|||repeated measures model||Treatment difference uses placebo as the reference.|||-35.83|-48.34|< 0.0001
91648127|NCT02392559|183188802|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91781881|NCT02284243|183443021|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to perceptible and meaningful pain relief|Log Rank|||||||<0.05
91781882|NCT02284243|183443022|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to ≥30% and ≥50% reduction in pain|Cochran-Mantel-Haenszel|Test for general association stratified by site||||||<0.05
91781883|NCT02284243|183443024|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Log Rank|||||||0.0009
91781884|NCT02284243|183443025|SUPERIORITY_OR_OTHER|||||||0.7718|||||||Cochran-Mantel-Haenszel|||||||0.7718
91781885|NCT01094119|183443154|SUPERIORITY|||||||0.0069|||||||Regression, Logistic|||||||0.0069
91781886|NCT00357903|183443180|SUPERIORITY_OR_OTHER||Standardized incidence rate|0.0||||||95.0|0.0|53.87||||||||53.87|0.00|
91781887|NCT00357903|183443180|SUPERIORITY_OR_OTHER||Standardized incidence rate|1.3||||||95.0|0.97|1.71||||||||1.71|0.97|
91781888|NCT05006573|183443254|SUPERIORITY||Risk Ratio (RR)|1.14||||0.5911|TWO_SIDED|95.0|0.71|1.82|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Placebo) and its 95% CI are estimated using a negative binomial model. The covariates include treatment arm, baseline blood eosinophil category, and number of exacerbations from previous year.|||1.82|0.71|0.5911
91781889|NCT05006573|183443255|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.6677|TWO_SIDED|95.0|0.67|1.91|||Regression, Cox||The analysis is performed using cox proportional hazards model with covariates of treatment group, number of exacerbations in previous year and baseline eosinophil category.|||1.91|0.67|0.6677
91781890|NCT02864394|183443284|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1276|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||Treatment comparison (Hazard Ratio, HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. One-sided p-value was based on log-rank test.||1.14|0.61|0.1276
91781891|NCT02864394|183443285|OTHER||Hazard Ratio (HR)|0.75||||0.0076|TWO_SIDED|95.0|0.6|0.95|||Log Rank|||OS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||0.95|0.60|0.0076
91781892|NCT02864394|183443286|OTHER||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.54|1.07|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. A nominal one-sided p-value for testing was based on log-rank test.||1.07|0.54|0.0534
91781893|NCT02864394|183443287|OTHER||Hazard Ratio (HR)|0.84||||0.0847|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||1.08|0.66|0.0847
91521379|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.289|TWO_SIDED|95.0|-20.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||67|-20|0.289
91781894|NCT02864394|183443288|OTHER||Difference in Percentage|21.0|||<|0.0001|TWO_SIDED|95.0|11.5|30.7|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on the Miettinen \& Nurminen method. A nominal one-sided p-value for testing was calculated.||30.7|11.5|<0.0001
91781895|NCT02864394|183443289|OTHER||Difference in Percentage|15.0|||<|0.0001|TWO_SIDED|95.0|8.8|21.6|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on Miettinen \& Nurminen method stratified by PD-L1 expression status (TPS\>=50% vs. TPS 1-49%). If no participants were in one of the treatment arms involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison. A nominal one-sided p-value for testing was calculated.||21.6|8.8|<0.0001
91781896|NCT02656693|183443304|SUPERIORITY|||||||0.00017|||||||Mixed Models Analysis|||||||0.00017
91781897|NCT02656693|183443306|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
91781898|NCT02656693|183443308|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
91781899|NCT02656693|183443309|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91648128|NCT02392559|183188803|SUPERIORITY||treatment difference|-68.6|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-83.1|-54.0||Treatment difference uses placebo as the reference.|repeated measures model|||||-54.0|-83.1|< 0.0001
91781900|NCT02656693|183443311|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91781901|NCT02656693|183443312|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91781902|NCT02656693|183443313|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
91781903|NCT02656693|183443314|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
91781904|NCT02656693|183443315|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
91781905|NCT02656693|183443316|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91781906|NCT02656693|183443317|SUPERIORITY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
91781907|NCT02656693|183443318|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
91781908|NCT02656693|183443319|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
91781909|NCT02656693|183443320|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
91781910|NCT02656693|183443321|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
91781911|NCT02656693|183443322|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
91781912|NCT02656693|183443323|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
91590008|NCT04409353|183069846|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.28||||0.8363|TWO_SIDED|95.0|-2.92|2.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||2.37|-2.92|0.8363
91590009|NCT04409353|183069847|OTHER||Odds Ratio (OR)|0.83||||0.514|TWO_SIDED|95.0|0.48|1.44||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||1.44|0.48|0.514
91590010|NCT04409353|183069847|OTHER||Odds Ratio (OR)|1.35||||0.28|TWO_SIDED|95.0|0.78|2.36||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||2.36|0.78|0.280
91781913|NCT02656693|183443324|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
91781914|NCT02656693|183443325|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
91590011|NCT04252287|183069874|SUPERIORITY||LS mean difference|4.3||||0.016|TWO_SIDED|95.0|0.8|7.8|||ANCOVA|||||7.8|0.8|0.016
91590012|NCT04252287|183069875|SUPERIORITY||LS mean difference|29.8||||0.852|TWO_SIDED|95.0|-284.4|344.1|||ANCOVA|||||344.1|-284.4|0.852
91590013|NCT02564926|183069888|OTHER||LS mean difference (kg)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.346|-1.819|||ANCOVA|||||-1.819|-3.346|<0.001
91590014|NCT02564926|183069889|OTHER||LS mean difference (%)|-0.46||||0.014|TWO_SIDED|95.0|-0.821|-0.094|||Mixed Models Analysis|||||-0.094|-0.821|0.014
91590015|NCT02564926|183069890|OTHER||Odds Ratio (OR)|1.45||||0.343|TWO_SIDED|95.0|0.673|3.113|||Regression, Logistic|||||3.113|0.673|0.343
91590016|NCT02564926|183069891|OTHER||LS mean difference (mg/dL)|-18.25||||0.006|TWO_SIDED|95.0|-31.14|-5.351|||Mixed Models Analysis|||||-5.351|-31.140|0.006
91590017|NCT02564926|183069892|OTHER||LS mean difference (kg)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.667|-2.631|||Mixed Models Analysis|||||-2.631|-4.667|<0.001
91590018|NCT02564926|183069893|OTHER||LS mean difference (cm)|-2.21||||0.006|TWO_SIDED|95.0|-3.785|-0.635|||Mixed Models Analysis|||||-0.635|-3.785|0.006
91590019|NCT02564926|183069894|OTHER||LS mean difference (kg/m2)|-1.37|||<|0.001|TWO_SIDED|95.0|-1.742|-0.99|||Mixed Models Analysis|||||-0.990|-1.742|<0.001
91590020|NCT02564926|183069895|OTHER||LS mean difference (mmHg)|-6.81||||0.002|TWO_SIDED|95.0|-10.969|-2.641|||Mixed Models Analysis|||||-2.641|-10.969|0.002
91590021|NCT02564926|183069896|OTHER||LS mean difference (mmHg)|-2.61||||0.11|TWO_SIDED|95.0|-5.829|0.6|||Mixed Models Analysis|||||0.600|-5.829|0.110
91590022|NCT02564926|183069897|OTHER||LS mean difference (cm2)|-17.55||||0.002|TWO_SIDED|95.0|-28.603|-6.489|||ANCOVA|||||-6.489|-28.603|0.002
91590023|NCT02564926|183069898|OTHER||LS mean difference (cm2)|-18.39|||<|0.001|TWO_SIDED|95.0|-27.561|-9.218|||ANCOVA|||||-9.218|-27.561|<0.001
91590024|NCT02564926|183069899|OTHER||LS mean difference|-0.03||||0.503|TWO_SIDED|95.0|-0.127|0.063|||ANCOVA|||||0.063|-0.127|0.503
91590025|NCT02564926|183069900|OTHER||LS mean difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.992|-0.54|||ANCOVA|||||-0.540|-1.992|<0.001
91781915|NCT02656693|183443326|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91781916|NCT02656693|183443327|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||||||0.42
91781917|NCT02656693|183443328|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
91590026|NCT02564926|183069901|OTHER||LS mean difference (ng/mL)|657.71||||0.044|TWO_SIDED|95.0|18.325|1297.101|||ANCOVA|||||1297.101|18.325|0.044
91590027|NCT02564926|183069902|OTHER||LS mean difference (mg/L)|-0.12||||0.756|TWO_SIDED|95.0|-0.858|0.625|||ANCOVA|||||0.625|-0.858|0.756
91590028|NCT02564926|183069903|OTHER||LS mean difference (%)|-1.94|||<|0.001|TWO_SIDED|95.0|-2.807|-1.082|||ANCOVA|||||-1.082|-2.807|<0.001
91590029|NCT01554488|183069906|OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-5.03|2.92||||||All of the comparisons were based on mixed effects linear regression models with visit and group\*visit as fixed effects and subject as a random effect. Confidence intervals for the treatment difference (group\*visit interaction) were constructed using the Wald method.||2.92|-5.03|
91781918|NCT02656693|183443329|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91781919|NCT02223702|183443382|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Friedman Test|All rows were compared to eachother||||||<0.01
91781920|NCT02223702|183443383|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|All rows were compared to eachother||||||<0.01
91781921|NCT00880919|183443388|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||Mean changes were calculated using each groups linear and quadratic effects||||.015
91790186|NCT02660138|183459524|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|84.81|||<|0.0001|TWO_SIDED|95.0|43.73|125.89|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||125.89|43.73|<0.0001
91590030|NCT04600336|183069924|SUPERIORITY||Mean Difference (Final Values)|-9.11||||0.0019|TWO_SIDED|90.0|-13.76|-4.46|||t-test, 2 sided|||||-4.46|-13.76|0.0019
91590031|NCT04600336|183069924|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.0732|TWO_SIDED|90.0|-9.7|-0.48|||t-test, 2 sided|||||-0.48|-9.70|0.0732
91590032|NCT04600336|183069927|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||||||0.0120
91590033|NCT04600336|183069930|SUPERIORITY|||||||0.0057|||||||Kruskal-Wallis|||||||0.0057
91590034|NCT04223791|183069935|NON_INFERIORITY|Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points.|Estimated difference|0.31|||<|0.001|TWO_SIDED|95.0|-1.19|1.96||p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.|Unstratified Miettinen and Nurminen||Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||1.96|-1.19|<.001
91590035|NCT04223791|183069936|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-3.5|||||TWO_SIDED|95.0|-10.4|3.4|||||Based on Miettinen and Nurminen method|||3.4|-10.4|
91590036|NCT04223791|183069937|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-0.02|||||TWO_SIDED|95.0|-2.7|2.6|||||Based on Miettinen and Nurminen method|||2.6|-2.7|
91590037|NCT04223791|183069950|SUPERIORITY||Treatment Difference|-0.3||||0.392|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|Model included terms for baseline weight, sex, race, and treatment.|Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||0.39|-0.99|0.392
91590038|NCT02366728|183069962|OTHER|||||||0.072|||||||Log Rank|||||||0.072
91590039|NCT02366728|183069962|OTHER|||||||0.089|||||||Log Rank|||||||0.089
91590040|NCT02366728|183069963|OTHER|||||||0.0195|||||||Wilcoxon (Mann-Whitney)|||||||0.0195
91590041|NCT02366728|183069964|OTHER|||||||0.4|||||||Log Rank|||||||0.40
91590042|NCT02366728|183069965|OTHER|||||||0.4|||||||Log Rank|||||||0.40
91590043|NCT02366728|183069966|OTHER|||||||0.16|||||||Log Rank|||||||0.16
91590044|NCT02366728|183069966|OTHER|||||||0.078|||||||Log Rank|||||||0.078
91590045|NCT02366728|183069967|OTHER|||||||0.64|||||||Log Rank|||||||0.64
91590046|NCT02366728|183069968|OTHER|||||||0.29|||||||Log Rank|||||||0.29
91590047|NCT01187550|183070090|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Wilcoxon rank sum test|||||||0.194
91590048|NCT01187550|183070091|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Wilcoxon rank sum test|||||||0.752
91590049|NCT01187550|183070092|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon rank sum test|||||||0.710
91590050|NCT01187550|183070093|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Wilcoxon rank sum test|||||||0.265
91590051|NCT01187550|183070094|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Wilcoxon rank sum test|||||||0.308
91590052|NCT01187550|183070095|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon rank sum test|||For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.078
91590053|NCT01187550|183070095|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Wilcoxon rank sum test|||For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.033
91590054|NCT01187550|183070095|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon rank sum test|||For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.041
91590055|NCT01187550|183070095|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon rank sum test|||For triglycerides: Wilcoxon rank sum test was used to calculate p-value.||||0.091
91590056|NCT00129623|183070096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1226|||<|0.0001|TWO_SIDED|95.0|2.9613|5.2838||The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, \>3 years) as independent factors.|ANOVA|||"H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).~H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD)."||5.2838|2.9613|<0.0001
91590057|NCT00129623|183070102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.51|||||TWO_SIDED|95.0|5.12|30.56||||||Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||30.56|5.12|
91590058|NCT00129623|183070102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.59|||||TWO_SIDED|95.0|3.8|19.42||||||Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||19.42|3.80|
91590059|NCT00129623|183070102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.8|||||TWO_SIDED|95.0|5.17|36.79||||||Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||36.79|5.17|
91590060|NCT00596934|183070105|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P\<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study||||0.015
91590061|NCT00596934|183070106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91590062|NCT00596934|183070107|SUPERIORITY_OR_OTHER|||||||0.074||||||p = 0.074|t-test, 2 sided|||||||0.074
91590063|NCT00596934|183070108|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91590064|NCT00596934|183070109|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
91590065|NCT00596934|183070110|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
91590066|NCT00596934|183070111|SUPERIORITY_OR_OTHER|||||||0.195||||||p-value = 0.195.|t-test, 2 sided|||||||0.195
91590067|NCT00596934|183070112|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
91590068|NCT03239483|183070129|SUPERIORITY|||||||0.072|||||||Fisher Exact|||two-sided Fisher's Exact Test||||0.072
91590069|NCT03239483|183070134|SUPERIORITY|||||||1||||||This is a calculated p-value. P-values of 1.0 are possible when using the Fisher Exact test method.|Fisher Exact|||||||1.00
91590070|NCT03239483|183070135|SUPERIORITY|||||||0.591|||||||Fisher Exact|||||||0.591
91590071|NCT00056862|183070177|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||Null hypothesis: first phase decline in HCV RNA are the same for the two groups||||0.002
91590072|NCT00056862|183070179|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups||||0.2
91590073|NCT00056862|183070180|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0|||||Log Rank|||Null hypothesis: the time to negativity for the two groups are same||||0.047
91590074|NCT00729781|183070193|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|57.8||||0.19|ONE_SIDED|97.5|42.2||||One-sided, binomial exact test|||This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was \< 0.025, the objective would have been met.|||42.2|0.19
91590075|NCT00729781|183070194|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|15.6|||>|0.99|ONE_SIDED|97.5|0.05||||One-sided, binomial exact test||||||0.05|>0.99
91590076|NCT02378220|183070212|OTHER||Risk Ratio (RR)|0.65||||0.21|TWO_SIDED|95.0|0.32|1.28||P-value for 30 days measure.|Regression, Poisson|||||1.28|0.32|0.21
91590077|NCT02378220|183070212|OTHER||Risk Ratio (RR)|0.48||||0.007|TWO_SIDED|95.0|0.27|0.82||P-Value for 60 days measure|Regression, Poisson|||||0.82|0.27|0.007
91590078|NCT02378220|183070213|OTHER||Risk Ratio (RR)|0.62||||0.16|TWO_SIDED|95.0|0.31|1.21||P-Value for 30 days measure|Regression, Poisson|||||1.21|0.31|0.16
91590079|NCT02378220|183070213|OTHER||Risk Ratio (RR)|0.58||||0.045|TWO_SIDED|95.0|0.34|0.99|||Regression, Poisson|||||0.99|0.34|0.045
91590080|NCT02378220|183070214|OTHER||Hazard Ratio (HR)|0.59||||0.1|TWO_SIDED|95.0|0.31|1.12|||Log Rank|||||1.12|0.31|0.10
91590081|NCT02378220|183070215|OTHER||Hazard Ratio (HR)|0.6||||0.09|TWO_SIDED|95.0|0.33|1.1|||Log Rank|||||1.10|0.33|0.09
91590082|NCT05105789|183070239|SUPERIORITY|"One-sample binomial test. Null hypothesis: NPV of BinaxNOW at Home testing is at most 91%.~Alternative hypothesis: NPV of BinaxNOW at Home testing is greater than 91%."|Kappa Co-efficient|100.0||||0.0015|TWO_SIDED|95.0|95.0|100.0|||one-sample binomial test||binary outcome|Negative Predictive Value||100|95|0.0015
91590083|NCT05105789|183070239|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.3308|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.3308
91590084|NCT05105789|183070239|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.0536|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0536
91590085|NCT05105789|183070240|EQUIVALENCE|Concordance between the PCR test results will be evaluated by calculating the Kappa statistic which will be reported along with corresponding two-sided 95% confidence interval. The nonparametric bootstrap technique will be used to construct the confidence interval. A kappa statistic of \>0.95 will be considered as sufficient to define lollipop swab test non-inferior to the gold-standard PCR testing of nasal swabs.|Kappa Co-efficient|0.91|||||TWO_SIDED|95.0|0.78|1.0||||||Kappa statistics for Nasal Swab PCR vs Lollipop Swab PCR||1.00|0.78|
91590086|NCT05105789|183070241|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.201|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.2010
91590087|NCT05105789|183070241|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.0705|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0705
91590088|NCT00728481|183070244|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison between arms for a histologic response||||1.00
91590089|NCT00728481|183070249|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Fisher Exact|||Comparison between arms for a symptomatic response||||0.76
91590090|NCT01505010|183070252|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_ERROR_OF_MEAN|8.5||0.018|TWO_SIDED||||||Mixed Models Analysis|Adjusted for the baseline 24-h systolic blood pressure|Difference at 6 months in 24-h systolic blood pressure (control minus intervention)|We used mixed models to compare blood pressure changes between randomized groups at 6 months, while adjusting for the baseline blood pressure; statistical significance was a P-value less than 0.05 on two-sided tests.||||0.018
91590091|NCT01505010|183070253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|4.87||0.86|TWO_SIDED||||||t-test, 2 sided|||Difference between control and intervention group at 6 months||||0.86
91590092|NCT01505010|183070254|SUPERIORITY||Median Difference (Final Values)|1.7||||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcocon rank sum test||||0.032
91590093|NCT01505010|183070254|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.8||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.032
91590094|NCT02558231|183070275|SUPERIORITY||Ratio of geometric Least Square mean|0.96||||0.4239|TWO_SIDED|95.0|0.86|1.07|||ANCOVA|||||1.07|0.86|0.4239
91590095|NCT02558231|183070276|SUPERIORITY||Least Square (LS) Mean difference|-1.43||||0.8758|TWO_SIDED|95.0|-19.393|16.538|||ANCOVA|||||16.538|-19.393|0.8758
91590096|NCT02558231|183070277|SUPERIORITY||Ratio of geometric LS mean|1.03||||0.8529|TWO_SIDED|95.0|0.77|1.371|||ANCOVA|||||1.371|0.770|0.8529
91590097|NCT02558231|183070279|SUPERIORITY||LS Mean Difference|-0.72||||0.4998|TWO_SIDED|95.0|-2.834|1.386|||ANCOVA|||||1.386|-2.834|0.4998
91590098|NCT02558231|183070280|SUPERIORITY||LS Mean Difference|-0.09||||0.8528|TWO_SIDED|95.0|-1.003|0.83|||ANCOVA|||||0.830|-1.003|0.8528
91590099|NCT02558231|183070281|SUPERIORITY||LS Mean Difference|2.4||||0.9474|TWO_SIDED|95.0|-69.368|74.178|||ANCOVA|||||74.178|-69.368|0.9474
91590100|NCT02558231|183070282|SUPERIORITY||LS Mean Difference|0.13||||0.1902|TWO_SIDED|95.0|-0.066|0.328|||ANCOVA|||||0.328|-0.066|0.1902
91590101|NCT02558231|183070283|SUPERIORITY||LS Mean Difference|-1.2||||0.1227|TWO_SIDED|95.0|-2.737|0.327|||ANCOVA|||||0.327|-2.737|0.1227
91590102|NCT02558231|183070284|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0867|TWO_SIDED|95.0|0.32|1.09|||Log Rank|||||1.09|0.32|0.0867
91590103|NCT03933397|183070288|SUPERIORITY|||||||0.909|||||||Regression, Linear|||||||0.909
91590104|NCT01294150|183070310|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance|t-test, 2 sided|||||||0.003
91590105|NCT00698932|183070323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|-0.65|-0.34|||ANCOVA|\*adjusted for baseline HbA1c||||-0.34|-0.65|<0.0001
91590106|NCT00698932|183070324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.06|-0.39|||ANCOVA|\*adjusted for baseline FPG||||-0.39|-1.06|<0.0001
91590107|NCT00698932|183070325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.12|STANDARD_ERROR_OF_MEAN|3.053|<|0.0001||95.0|-19.12|-7.13|||ANCOVA|\*adjusted for baseline FPG||||-7.13|-19.12|<0.0001
91590108|NCT00698932|183070326|SUPERIORITY_OR_OTHER||Median Difference (Net)|-182.0|STANDARD_ERROR_OF_MEAN|54.4||0.001||95.0|-289.0|-74.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-74|-289|0.001
91590109|NCT00698932|183070327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3280.0|STANDARD_ERROR_OF_MEAN|980.0||0.001||95.0|-5214.0|-1345.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-1345|-5214|0.001
91590110|NCT00698932|183070328|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.0001||95.0|8.9|24.9|||ANCOVA|||||24.9|8.9|<0.0001
91590111|NCT01621542|183070330|OTHER|None specified||||||||||||||||The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|||
91590112|NCT00708175|183070339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.17|TWO_SIDED|95.0|-1.33|0.24||P-value is from a 1-way ANCOVA with treatment group as a factor and baseline BMD as a covariate. There were no multiplicity adjustments.|ANCOVA|||The sample size was calculated using a precision approach to estimate the difference between the pioglitazone and placebo treatment groups in the percent change from baseline in BMD.||0.24|-1.33|0.170
91590113|NCT00708175|183070340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.64|TWO_SIDED|95.0|-0.91|0.56||P-value is from a 1-way ANCOVA with treatment group as a factor and the Month 12 BMD value as a covariate. There were no multiplicity adjustments.|ANCOVA|||||0.56|-0.91|0.640
91590114|NCT03672461|183070360|SUPERIORITY||Model based LS mean difference|0.29||||0.056|TWO_SIDED|95.0|-0.01|0.6|||Mixed Models Analysis|adjusted for baseline value. Repeated measures mixed models, unstructured variance co-variance matrix||Null Hypothesis: Yoga is not associated with improvement in change from baseline in Total Urinary Incontinence Episodes||0.6|-0.01|0.056
91590115|NCT03672461|183070361|SUPERIORITY||Model based LS mean difference|0.03||||0.757|TWO_SIDED|95.0|-0.15|0.2|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.2|-0.15|0.757
91709110|NCT03035916|183311327|OTHER|||||||0.167|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.167
91590116|NCT03672461|183070362|SUPERIORITY||Model based LS mean difference|0.22||||0.048|TWO_SIDED|95.0|0.0|0.45|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.45|0|0.048
91590117|NCT03672461|183070363|SUPERIORITY||Model based LS mean difference|0.82||||0.911|TWO_SIDED|95.0|-13.6|15.23|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||15.23|-13.6|0.911
91590118|NCT03672461|183070364|SUPERIORITY||Model based LS mean difference|3.13||||0.041|TWO_SIDED|95.0|0.13|6.13|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.13|0.13|0.041
91590119|NCT03672461|183070365|SUPERIORITY||Model based LS mean difference|0.07||||0.564|TWO_SIDED|95.0|-0.16|0.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.3|-0.16|0.564
91590120|NCT03672461|183070366|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
91590121|NCT03672461|183070367|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
91590122|NCT03672461|183070368|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
91590123|NCT03672461|183070369|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
91590124|NCT03672461|183070370|SUPERIORITY||Model based LS mean difference|0.24||||0.691|TWO_SIDED|95.0|-0.95|1.43|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.43|-0.95|0.691
91590125|NCT03672461|183070371|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
91709111|NCT03035916|183311327|OTHER|||||||0.445|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.445
91709112|NCT03035916|183311327|OTHER|||||||0.489|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.489
91590126|NCT03672461|183070372|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
91590127|NCT03672461|183070373|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||5.84|-3.87|0.689
91590128|NCT03672461|183070374|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
91590129|NCT03672461|183070375|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
91590130|NCT03672461|183070376|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
91590131|NCT03672461|183070377|SUPERIORITY||Model based LS mean difference|1.21||||0.747|TWO_SIDED|95.0|-6.25|8.67|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||8.67|-6.25|0.747
91781922|NCT02863419|183443407|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.1|||<|0.0001|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|<0.0001
91781923|NCT02863419|183443407|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.0645|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|0.0645
91781924|NCT02863419|183443407|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.2|<0.0001
91781925|NCT02863419|183443407|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|<0.0001
91781926|NCT02863419|183443407|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2||||0.0056|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|0.0056
91590132|NCT03672461|183070378|SUPERIORITY||Model based LS mean difference|-2.76||||0.459|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.459
91590133|NCT03672461|183070379|SUPERIORITY||Model based LS mean difference|-2.0||||0.556|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.556
91648129|NCT02392559|183188803|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91648130|NCT02392559|183188804|SUPERIORITY||treatment difference|-35.04|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-41.79|-28.3|||repeated measures model||Treatment difference uses placebo as the reference.|||-28.30|-41.79|< 0.0001
91648131|NCT02392559|183188804|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91648132|NCT02392559|183188805|SUPERIORITY||treatment difference|-32.47|STANDARD_ERROR_OF_MEAN|3.21|<|0.0001|TWO_SIDED|95.0|-38.82|-26.13|||repeated measures model||Treatment difference uses placebo as the reference.|||-26.13|-38.82|< 0.0001
91648133|NCT02392559|183188805|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91648134|NCT02392559|183188806|SUPERIORITY||treatment difference|-30.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.0001|TWO_SIDED|95.0|-36.4|-24.21|||repeated measures model||Treatment difference uses placebo as the reference.|||-24.21|-36.40|< 0.0001
91648135|NCT02392559|183188806|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91648136|NCT02392559|183188807|SUPERIORITY||treatment difference|-36.38|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-42.97|-29.8|||repeated measures model||Treatment difference uses placebo as the reference.|||-29.80|-42.97|< 0.0001
91648137|NCT02392559|183188807|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
91781927|NCT02863419|183443407|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.2||||0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.4|0.0001
91648138|NCT03125915|183188820|SUPERIORITY||Beta|-3.62||||0.03|TWO_SIDED|95.0|-6.78|-0.46||A multi-level latent growth curve (LGC) with a intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-leve latent growth curve||For 1-Month Follow-Up, substance use module (SUM) among those who did not view CT Video|||-0.46|-6.78|.03
91590134|NCT03672461|183070380|SUPERIORITY||Model based LS mean difference|-3.26||||0.516|TWO_SIDED|95.0|-13.2|6.7|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.7|-13.2|0.516
91590135|NCT03672461|183070381|SUPERIORITY||Model based LS mean difference|-2.38||||0.154|TWO_SIDED|95.0|-5.68|0.91|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.91|-5.68|0.154
91590136|NCT03672461|183070382|SUPERIORITY||Model based LS mean difference|-2.22||||0.375|TWO_SIDED|95.0|-7.17|2.72|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.72|-7.17|0.375
91590137|NCT03672461|183070383|SUPERIORITY||Model based LS mean difference|-1.75||||0.287|TWO_SIDED|95.0|-5.0|1.5|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||1.5|-5|0.287
91590138|NCT03672461|183070384|SUPERIORITY||Model based LS mean difference|-1.63||||0.147|TWO_SIDED|95.0|-3.85|0.58||adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix|Mixed Models Analysis|||||0.58|-3.85|0.147
91648139|NCT03125915|183188820|SUPERIORITY||Beta|-1.67||||0.18|TWO_SIDED|95.0|-4.1|0.76||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did view the CT video.|||0.76|-4.10|.18
91648140|NCT03125915|183188820|SUPERIORITY||Beta|-0.35||||0.75|TWO_SIDED|95.0|-2.5|1.8||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow up, effect of CT video among those who completed the SUM.|||1.80|-2.50|0.75
91648141|NCT03125915|183188820|SUPERIORITY||Beta|-2.3||||0.14|TWO_SIDED|95.0|-5.37|0.77||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-Month follow up, effect of CT video among those who did not complete SUM.|||0.77|-5.37|0.14
91590139|NCT03672461|183070385|SUPERIORITY||Model based LS mean difference|-1.37||||0.495|TWO_SIDED|95.0|-5.36|2.61|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||2.61|-5.36|0.495
91590140|NCT03672461|183070386|SUPERIORITY||Model based LS mean difference|-2.82||||0.303|TWO_SIDED|95.0|-8.22|2.59|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.59|-8.22|0.303
91590141|NCT03672461|183070387|SUPERIORITY||Model based LS mean difference|2.97||||0.196|TWO_SIDED|95.0|-1.56|7.51|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||7.51|-1.56|0.196
91590142|NCT04667247|183070389|OTHER||ratio of frequencies|0.94||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
91590143|NCT04667247|183070392|OTHER||ratio of frequencies|1.022||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
91590144|NCT04667247|183070394|OTHER||ratio of frequencies|4.828||||0.061|TWO_SIDED||||||Chi-squared, Corrected|||||||0.061
91590145|NCT04667247|183070395|OTHER||ratio of frequencies|3.526||||0.1|TWO_SIDED||||||Chi-squared, Corrected|||||||.100
91590146|NCT04667247|183070396|OTHER||ratio of frequencies|0.005||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
91590147|NCT04667247|183070397|OTHER||ratio of frequencies|3.036||||0.162|TWO_SIDED||||||Chi-squared, Corrected|||||||.162
91590148|NCT04667247|183070399|OTHER||ratio of frequencies|0.151||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.00
91590149|NCT04667247|183070400|SUPERIORITY||F value|1.908||||0.174|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.174
91590150|NCT04667247|183070401|SUPERIORITY||F value|0.038||||0.846|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.846
91590151|NCT04667247|183070402|SUPERIORITY||F value|0.041||||0.841|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.841
91590152|NCT04667247|183070403|SUPERIORITY||F value|0.261||||0.612|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.612
91590153|NCT04667247|183070404|SUPERIORITY||F value|0.161||||0.69|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.690
91590154|NCT04667247|183070405|SUPERIORITY||F value|2.671||||0.109|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.109
91590155|NCT04667247|183070406|SUPERIORITY||F value|0.039||||0.844|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.844
91590156|NCT04667247|183070407|SUPERIORITY||F value|4.28||||0.044|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.044
91590157|NCT04667247|183070408|SUPERIORITY||F value|0.001||||0.989|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.989
91590158|NCT04667247|183070409|SUPERIORITY||F value|7.186||||0.01|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.010
91590159|NCT04667247|183070410|SUPERIORITY||F value|0.345||||0.56|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.560
91590160|NCT04667247|183070411|SUPERIORITY||F value|0.143||||0.707|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.707
91590161|NCT04667247|183070412|SUPERIORITY||F value|0.09||||0.765|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||0.765
91590162|NCT04667247|183070413|SUPERIORITY||F value|7.835||||0.005|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.005
91590163|NCT04667247|183070414|SUPERIORITY||F value|16.56|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||<0.001
91590164|NCT02012296|183070486|SUPERIORITY|||||||0.83|||||||Log Rank|||||||0.83
91590165|NCT02012296|183070487|SUPERIORITY|||||||0.21|||||||Log Rank|||||||0.21
91590166|NCT02012296|183070490|SUPERIORITY|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
91590167|NCT02012296|183070491|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91590168|NCT02012296|183070492|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91590169|NCT01681810|183070511|OTHER|Paired t-test comparing insulin stimulated glucose disposal at end of 12 weeks on nitrite drug to baseline (pre-drug) insulin stimulated glucose disposal.||||||0.2068|||||||t-test, 2 sided|||||||0.2068
91590170|NCT01681810|183070512|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.||||||0.0074||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0074
91590171|NCT01681810|183070513|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
91590172|NCT01681810|183070514|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
91590173|NCT01681810|183070515|OTHER|One-way repeated measures ANOVA comparing methemoglobin percent over time on nitrite drug to baseline (pre-drug) methemoglobin percent.||||||0.0127||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0127
91590174|NCT03627767|183070524|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.286|0.424||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.424|0.286|< 0.0001
91590175|NCT03627767|183070524|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.176|0.27||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.270|0.176|< 0.0001
91590176|NCT03627767|183070524|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.503|0.78||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.780|0.503|< 0.0001
91590177|NCT03627767|183070525|SUPERIORITY||Difference in percentage|0.0|||=|0.9495|TWO_SIDED|95.0|-1.0|1.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.1|-1.0|= 0.9495
91590178|NCT03627767|183070525|SUPERIORITY||Difference in percentage|-0.4|||=|0.5717|TWO_SIDED|95.0|-1.6|0.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.6|= 0.5717
91590179|NCT03627767|183070525|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.7|0.9||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.7|
91590180|NCT03627767|183070525|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.1|47.8||P-value was adjusted by disease severity at baseline and randomization strata|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.8|33.1|< 0.0001
91590181|NCT03627767|183070525|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.1|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.1|< 0.0001
91590182|NCT03627767|183070525|SUPERIORITY||Difference in percentage|22.1|||||TWO_SIDED|95.0|14.3|29.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.9|14.3|
91590183|NCT03627767|183070525|SUPERIORITY||Difference in percentage|35.1|||<|0.0001|TWO_SIDED|95.0|28.1|42.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.0|28.1|< 0.0001
91590184|NCT03627767|183070525|SUPERIORITY||Difference in percentage|51.5|||<|0.0001|TWO_SIDED|95.0|44.6|58.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.4|44.6|< 0.0001
91590185|NCT03627767|183070525|SUPERIORITY||Difference in percentage|16.5|||||TWO_SIDED|95.0|8.1|24.8||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.8|8.1|
91590186|NCT03627767|183070525|SUPERIORITY||Difference in percentage|32.2|||<|0.0001|TWO_SIDED|95.0|25.2|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.2|< 0.0001
91590187|NCT03627767|183070525|SUPERIORITY||Difference in percentage|46.9|||<|0.0001|TWO_SIDED|95.0|39.9|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.9|< 0.0001
91590188|NCT03627767|183070525|SUPERIORITY||Difference in percentage|14.2|||||TWO_SIDED|95.0|5.9|22.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.6|5.9|
91590189|NCT03627767|183070525|SUPERIORITY||Difference in percentage|25.5|||<|0.0001|TWO_SIDED|95.0|18.5|32.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.5|18.5|< 0.0001
91590190|NCT03627767|183070525|SUPERIORITY||Difference in percentage|42.5|||<|0.0001|TWO_SIDED|95.0|35.3|49.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.7|35.3|< 0.0001
91590191|NCT03627767|183070525|SUPERIORITY||Difference in percentage|17.1|||||TWO_SIDED|95.0|8.6|25.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.6|
91590192|NCT03627767|183070526|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
91709113|NCT03035916|183311327|OTHER|||||||0.159|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.159
91648142|NCT03125915|183188820|SUPERIORITY||Beta|-2.79||||0.013|TWO_SIDED|95.0|-5.0|-0.58||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who viewed the CT video.|||-0.58|-5.00|0.013
91648143|NCT03125915|183188820|SUPERIORITY||Beta|-2.09||||0.1|TWO_SIDED|95.0|-4.56|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who did not view CT video|||0.38|-4.56|0.10
91590193|NCT03627767|183070526|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.||0.0|0.0|
91590194|NCT03627767|183070526|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
91590195|NCT03627767|183070526|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.3|50.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.1|35.3|< 0.0001
91590196|NCT03627767|183070526|SUPERIORITY||Difference in percentage|55.4|||<|0.0001|TWO_SIDED|95.0|49.1|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|49.1|< 0.0001
91590197|NCT03627767|183070526|SUPERIORITY||Difference in percentage|12.9|||||TWO_SIDED|95.0|7.9|17.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.9|7.9|
91590198|NCT03627767|183070526|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|37.9|53.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.0|37.9|< 0.0001
91590199|NCT03627767|183070526|SUPERIORITY||Difference in percentage|63.0|||<|0.0001|TWO_SIDED|95.0|56.4|69.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.5|56.4|< 0.0001
91590200|NCT03627767|183070526|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|10.7|24.7||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||24.7|10.7|
91590201|NCT03627767|183070526|SUPERIORITY||Difference in percentage|41.0|||<|0.0001|TWO_SIDED|95.0|33.6|48.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.5|33.6|< 0.0001
91590202|NCT03627767|183070526|SUPERIORITY||Difference in percentage|58.3|||<|0.0001|TWO_SIDED|95.0|51.3|65.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||65.2|51.3|< 0.0001
91590203|NCT03627767|183070526|SUPERIORITY||Difference in percentage|17.5|||||TWO_SIDED|95.0|9.6|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.6|
91590204|NCT03627767|183070526|SUPERIORITY||Difference in percentage|35.3|||<|0.0001|TWO_SIDED|95.0|27.8|42.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.8|27.8|< 0.0001
91590205|NCT03627767|183070526|OTHER||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.3|62.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.4|48.3|< 0.0001
91590206|NCT03627767|183070526|SUPERIORITY||Difference in percentage|20.3|||||TWO_SIDED|95.0|12.1|28.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||28.5|12.1|
91781928|NCT02863419|183443408|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2||||0.0003|TWO_SIDED|95.0|-1.9|-0.6||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.9|0.0003
91781929|NCT02863419|183443408|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-3.0|-4.7|<0.0001
91521380|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.786|TWO_SIDED|95.0|-37.0|49.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||49|-37|0.786
91521381|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.0||||0.134|TWO_SIDED|95.0|-10.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||76|-10|0.134
91521382|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.0||||0.191|TWO_SIDED|95.0|-15.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||74|-15|0.191
91590207|NCT03627767|183070527|SUPERIORITY||Difference in percentage|0.7|||=|0.1848|TWO_SIDED|95.0|-0.3|1.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.7|-0.3|= 0.1848
91590208|NCT03627767|183070527|SUPERIORITY||Difference in percentage|0.3|||=|0.5971|TWO_SIDED|95.0|-0.9|1.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.6|-0.9|= 0.5971
91590209|NCT03627767|183070527|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.1|0.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.4|-1.1|
91590210|NCT03627767|183070527|SUPERIORITY||Difference in percentage|49.4|||<|0.0001|TWO_SIDED|95.0|42.0|56.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||56.8|42.0|< 0.0001
91590211|NCT03627767|183070527|SUPERIORITY||Difference in percentage|65.5|||<|0.0001|TWO_SIDED|95.0|59.3|71.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||71.7|59.3|< 0.0001
91590212|NCT03627767|183070527|SUPERIORITY||Difference in percentage|16.3|||||TWO_SIDED|95.0|10.3|22.3||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|10.3|
91590213|NCT03627767|183070527|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.2|50.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.2|35.2|< 0.0001
91590214|NCT03627767|183070527|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.0|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.0|< 0.0001
91590215|NCT03627767|183070527|SUPERIORITY||Difference in percentage|19.8|||||TWO_SIDED|95.0|12.3|27.4||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.4|12.3|
91781930|NCT02863419|183443408|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.9|-2.2|<0.0001
91781931|NCT02863419|183443408|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral sema 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.2|-4.8|<0.0001
91781932|NCT02863419|183443429|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.17||||0.4915|TWO_SIDED|95.0|0.75|1.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.80|0.75|0.4915
91781933|NCT02863419|183443429|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.48||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.48|0.21|<0.0001
91781934|NCT02863419|183443430|SUPERIORITY|This hypothesis was not controlled for multiplicity|Hazard Ratio (HR)|1.17||||0.6252|TWO_SIDED|95.0|0.62|2.22||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||2.22|0.62|0.6252
91781935|NCT02863419|183443430|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.09|<0.0001
91781936|NCT00297258|183443454|SUPERIORITY_OR_OTHER||percentage of participants|46.0||||0.653||90.0|11.0|47.6|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||47.6|11.0|0.653
91781937|NCT00297258|183443454|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
91781938|NCT00297258|183443454|SUPERIORITY_OR_OTHER||percentage of participants|49.0|||<|0.001||90.0|34.3|63.2|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||63.2|34.3|<0.001
91590216|NCT03627767|183070527|SUPERIORITY||Difference in percentage|39.5|||<|0.0001|TWO_SIDED|95.0|32.1|46.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.9|32.1|< 0.0001
91709114|NCT03035916|183311327|OTHER|||||||0.72|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.720
91781939|NCT00297258|183443454|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
91781940|NCT02839200|183443467|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
91590217|NCT03627767|183070527|SUPERIORITY||Difference in percentage|56.7|||<|0.0001|TWO_SIDED|95.0|49.8|63.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||63.7|49.8|< 0.0001
91590218|NCT03627767|183070527|SUPERIORITY||Difference in percentage|17.4|||||TWO_SIDED|95.0|9.3|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.3|
91590219|NCT03627767|183070527|SUPERIORITY||Difference in percentage|33.0|||<|0.0001|TWO_SIDED|95.0|25.7|40.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||40.4|25.7|< 0.0001
91590220|NCT03627767|183070527|SUPERIORITY||Difference in percentage|51.7|||<|0.0001|TWO_SIDED|95.0|44.6|58.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.8|44.6|< 0.0001
91590221|NCT03627767|183070527|SUPERIORITY||Difference in percentage|19.2|||||TWO_SIDED|95.0|10.8|27.6||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.6|10.8|
91590222|NCT03627767|183070528|SUPERIORITY||Difference in percentage|2.6|||=|0.3994|TWO_SIDED|95.0|-3.3|8.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.4|-3.3|= 0.3994
91590223|NCT03627767|183070528|SUPERIORITY||Difference in percentage|1.8|||=|0.5542|TWO_SIDED|95.0|-4.1|7.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.8|-4.1|= 0.5542
91590224|NCT03627767|183070528|SUPERIORITY||Difference in percentage|-0.8|||||TWO_SIDED|95.0|-6.5|5.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.0|-6.5|
91590225|NCT03627767|183070528|SUPERIORITY||Difference in percentage|37.5|||<|0.0001|TWO_SIDED|95.0|30.2|44.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.9|30.2|< 0.0001
91590226|NCT03627767|183070528|SUPERIORITY||Difference in percentage|63.3|||<|0.0001|TWO_SIDED|95.0|56.8|69.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.8|56.8|< 0.0001
91590227|NCT03627767|183070528|SUPERIORITY||Difference in percentage|25.5|||||TWO_SIDED|95.0|17.7|33.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||33.4|17.7|
91590228|NCT03627767|183070528|SUPERIORITY||Difference in percentage|36.9|||<|0.0001|TWO_SIDED|95.0|29.9|44.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.0|29.9|< 0.0001
91590229|NCT03627767|183070528|SUPERIORITY||Difference in percentage|54.2|||<|0.0001|TWO_SIDED|95.0|47.3|61.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.0|47.3|< 0.0001
91781941|NCT02839200|183443467|OTHER||LS mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.95||0.241|TWO_SIDED|95.0|-18.7|4.7|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||4.7|-18.7|0.241
91781942|NCT02839200|183443467|OTHER||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|6.0||0.072|TWO_SIDED|95.0|-22.6|1.0|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||1|-22.6|0.072
91781943|NCT02839200|183443467|OTHER||LS Mean difference|-16.2|STANDARD_ERROR_OF_MEAN|5.95||0.007|TWO_SIDED|95.0|-27.9|-4.5|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-4.5|-27.9|0.007
91590230|NCT03627767|183070528|SUPERIORITY||Difference in percentage|17.2|||||TWO_SIDED|95.0|8.9|25.5||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.9|
91590231|NCT03627767|183070528|SUPERIORITY||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|22.7|37.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|22.7|< 0.0001
91590232|NCT03627767|183070528|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.6|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.6|< 0.0001
91590233|NCT03627767|183070528|SUPERIORITY||Difference in percentage|16.9|||||TWO_SIDED|95.0|8.5|25.3||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.3|8.5|
91590234|NCT03627767|183070528|SUPERIORITY||Difference in percentage|27.4|||<|0.0001|TWO_SIDED|95.0|20.4|34.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||34.3|20.4|< 0.0001
91781944|NCT02839200|183443467|OTHER||LS Mean difference|-25.6|STANDARD_ERROR_OF_MEAN|5.92|<|0.001|TWO_SIDED|95.0|-37.3|-13.9|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-13.9|-37.3|< 0.001
91781945|NCT02839200|183443467|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|5.97||0.155|TWO_SIDED|95.0|-20.4|3.3|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||3.3|-20.4|0.155
91781946|NCT02453711|183443481|OTHER||Treatment difference (%-points)|-3.7|STANDARD_ERROR_OF_MEAN|1.13|=|0.0055|TWO_SIDED|95.0|-6.55|-0.85|||ANCOVA||Semaglutide 0.05 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-0.85|-6.55|=0.0055
91781947|NCT02453711|183443481|OTHER||Treatment difference (%-points)|-6.32|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-9.16|-3.49|||ANCOVA||Semaglutide 0.1 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-3.49|-9.16|<0.0001
91590235|NCT03627767|183070528|SUPERIORITY||Difference in percentage|43.8|||<|0.0001|TWO_SIDED|95.0|36.7|50.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.9|36.7|< 0.0001
91590236|NCT03627767|183070528|SUPERIORITY||Difference in percentage|16.8|||||TWO_SIDED|95.0|8.4|25.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.2|8.4|
91590237|NCT03627767|183070529|SUPERIORITY||Difference in percentage|0.3|||=|0.9313|TWO_SIDED|95.0|-7.5|8.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.1|-7.5|= 0.9313
91590238|NCT03627767|183070529|SUPERIORITY||Difference in percentage|-2.1|||=|0.6043|TWO_SIDED|95.0|-9.8|5.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.7|-9.8|= 0.6043
91590239|NCT03627767|183070529|SUPERIORITY||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-10.0|5.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-10.0|
91590240|NCT03627767|183070529|SUPERIORITY||Difference in percentage|11.6|||<|0.0001|TWO_SIDED|95.0|6.6|16.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.5|6.6|< 0.0001
91590241|NCT03627767|183070529|SUPERIORITY||Difference in percentage|25.3|||<|0.0001|TWO_SIDED|95.0|19.4|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|19.4|< 0.0001
91590242|NCT03627767|183070529|SUPERIORITY||Difference in percentage|13.5|||||TWO_SIDED|95.0|6.6|20.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.4|6.6|
91709115|NCT03035916|183311327|OTHER|||||||0.026|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.026
91781948|NCT02453711|183443481|OTHER||Treatment difference (%-points)|-9.31|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-12.15|-6.46|||ANCOVA||Semaglutide 0.2 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.46|-12.15|<0.0001
91590243|NCT03627767|183070529|SUPERIORITY||Difference in percentage|12.9|||<|0.0001|TWO_SIDED|95.0|7.7|18.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||18.0|7.7|< 0.0001
91590244|NCT03627767|183070529|SUPERIORITY||Difference in percentage|26.0|||<|0.0001|TWO_SIDED|95.0|19.9|32.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.0|19.9|< 0.0001
91590245|NCT03627767|183070529|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|6.3|20.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.6|6.3|
91590246|NCT03627767|183070529|SUPERIORITY||Difference in percentage|11.7|||<|0.0001|TWO_SIDED|95.0|6.5|16.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.8|6.5|< 0.0001
91590247|NCT03627767|183070529|SUPERIORITY||Difference in percentage|25.7|||<|0.0001|TWO_SIDED|95.0|19.6|31.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.8|19.6|< 0.0001
91590248|NCT03627767|183070529|SUPERIORITY||Difference in percentage|14.1|||||TWO_SIDED|95.0|7.0|21.2||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.2|7.0|
91590249|NCT03627767|183070529|SUPERIORITY||Difference in percentage|14.6|||<|0.0001|TWO_SIDED|95.0|9.2|20.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.0|9.2|< 0.0001
91590250|NCT03627767|183070529|SUPERIORITY||Difference in percentage|24.5|||<|0.0001|TWO_SIDED|95.0|18.4|30.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.5|18.4|< 0.0001
91590251|NCT03627767|183070529|SUPERIORITY||Difference in percentage|10.0|||||TWO_SIDED|95.0|2.7|17.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.2|2.7|
91590252|NCT03627767|183070530|SUPERIORITY||Difference in percentage|1.8|||=|0.6082|TWO_SIDED|95.0|-5.0|8.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.5|-5.0|= 0.6082
91590253|NCT03627767|183070530|SUPERIORITY||Difference in percentage|0.2|||=|0.964|TWO_SIDED|95.0|-6.7|7.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.0|-6.7|= 0.9640
91590254|NCT03627767|183070530|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-9.1|4.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||4.4|-9.1|
91590255|NCT03627767|183070530|SUPERIORITY||Difference in percentage|38.9|||<|0.0001|TWO_SIDED|95.0|31.2|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|31.2|< 0.0001
91590256|NCT03627767|183070530|SUPERIORITY||Difference in percentage|59.7|||<|0.0001|TWO_SIDED|95.0|52.7|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|52.7|< 0.0001
91590257|NCT03627767|183070530|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|12.7|29.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.0|12.7|
91590258|NCT03627767|183070530|SUPERIORITY||Difference in percentage|33.9|||<|0.0001|TWO_SIDED|95.0|26.6|41.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.2|26.6|< 0.0001
91590259|NCT03627767|183070530|SUPERIORITY||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.2|62.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.3|48.2|< 0.0001
91590260|NCT03627767|183070530|SUPERIORITY||Difference in percentage|21.7|||||TWO_SIDED|95.0|13.2|30.2||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.2|13.2|
91590261|NCT03627767|183070530|SUPERIORITY||Difference in percentage|29.7|||<|0.0001|TWO_SIDED|95.0|22.7|36.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||36.7|22.7|< 0.0001
91590262|NCT03627767|183070530|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|38.4|52.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||52.7|38.4|< 0.0001
91590263|NCT03627767|183070530|SUPERIORITY||Difference in percentage|16.0|||||TWO_SIDED|95.0|7.4|24.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.6|7.4|
91590264|NCT03627767|183070530|SUPERIORITY||Difference in percentage|19.9|||<|0.0001|TWO_SIDED|95.0|13.0|26.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.8|13.0|< 0.0001
91590265|NCT03627767|183070530|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|32.8|48.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.1|32.8|< 0.0001
91590266|NCT03627767|183070530|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|11.8|30.0||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.0|11.8|
91590267|NCT03627767|183070533|SUPERIORITY||LSM difference|0.0|||=|0.9207|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9207
91648144|NCT03125915|183188820|SUPERIORITY||Beta|0.4||||0.78|TWO_SIDED|95.0|-2.35|3.16||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT Video among those who completed the SUM|A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.||3.16|-2.35|0.78
91648145|NCT03125915|183188820|SUPERIORITY||Beta|-0.3||||0.75|TWO_SIDED|95.0|-2.12|1.53||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||1.53|-2.12|0.75
91709116|NCT03035916|183311327|OTHER|||||||0.011|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.011
91781949|NCT02453711|183443481|OTHER||Treatment difference (%-points)|-8.88|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-11.72|-6.03|||ANCOVA||Semaglutide 0.3 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.03|-11.72|<0.0001
91590268|NCT03627767|183070533|SUPERIORITY||LSM difference|0.0|||=|0.9998|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9998
91590269|NCT03627767|183070533|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|
91590270|NCT03627767|183070533|SUPERIORITY||LSM difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.7|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.5|< 0.0001
91590271|NCT03627767|183070533|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.8|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.8|-3.6|< 0.0001
91590272|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.4|
91590273|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-2.0|< 0.0001
91590274|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-2.5|< 0.0001
91590275|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.9|-0.1||||||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.9|
91590276|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.0|||=|0.0039|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.7|= 0.0039
91648146|NCT03125915|183188820|SUPERIORITY||Beta|-3.93||||0.014|TWO_SIDED|95.0|-7.06|-0.81||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed the CT video.|||-0.81|-7.06|0.014
91590277|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.2|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.5|< 0.0001
91709117|NCT03035916|183311327|OTHER|||||||0.763|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.763
91781950|NCT02453711|183443481|OTHER||Treatment difference (%-points)|-11.55|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-14.38|-8.72|||ANCOVA||Semaglutide 0.4 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-8.72|-14.38|<0.0001
91648147|NCT03125915|183188820|SUPERIORITY||Beta|-0.57||||0.67|TWO_SIDED|95.0|-3.16|2.03||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of SUM among those who did not view CT video.|||2.03|-3.16|0.67
91781951|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.0135||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline Hgb \<10.80 versus modeled Hgb change from baseline in participants with Baseline Hgb \>= 10.80||||0.0135
91781952|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.5082||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline weight \<= 80.5 Kg versus modeled Hgb change from baseline in participants with Baseline weight \> 80.5||||0.5082
91781953|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino versus modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino||||0.9770
91781954|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.0618||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline geographic ancestry as African American versus modeled Hgb change from baseline in participants with no geographic ancestry as African American||||0.0618
91781955|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline gender as male versus modeled Hgb change from baseline in participants with Baseline gender female||||0.7495
91781956|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.7865||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline age \<65 years versus modeled Hgb change from baseline in participants with Baseline age \>=65 years||||0.7865
91781957|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.0622||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline co-ad with food versus modeled Hgb change from baseline in participants with Baseline co-ad without food||||0.0622
91781958|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.2044||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline diabetes presence versus modeled Hgb change from baseline in participants with no Baseline diabetes||||0.2044
91781959|NCT01587924|183443518|SUPERIORITY_OR_OTHER|||||||0.8537||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline region as the US and Canada versus modeled Hgb change from baseline in participants with Baseline region as not the US and Canada||||0.8537
91781960|NCT00606593|183443549|SUPERIORITY_OR_OTHER||Least square means treatment effect|-10.4||||0.0018|TWO_SIDED|95.0|-17.0|-3.9|||Linear model|||||-3.9|-17.0|0.0018
91781961|NCT00606593|183443549|SUPERIORITY_OR_OTHER||Least square means treatment effect|-19.2|||<|0.0001|TWO_SIDED|95.0|-25.7|-12.6|||Linear model|||||-12.6|-25.7|<0.0001
91781962|NCT00606593|183443549|SUPERIORITY_OR_OTHER||Least square means treatment effect|-31.4|||<|0.0001|TWO_SIDED|95.0|-38.0|-24.9|||Linear model|||||-24.9|-38.0|<0.0001
91781963|NCT00606593|183443549|SUPERIORITY_OR_OTHER||Least square means treatment effect|-46.5|||<|0.0001|TWO_SIDED|95.0|-53.3|-39.9|||Linear model|||||-39.9|-53.3|<0.0001
91781964|NCT00606593|183443550|SUPERIORITY_OR_OTHER||Least square means treatment effect|14.3|||<|0.0001|TWO_SIDED|95.0|7.4|21.2|||Linear model|||||21.2|7.4|<0.0001
91781965|NCT00606593|183443550|SUPERIORITY_OR_OTHER||Least square means treatment effect|21.5|||<|0.0001|TWO_SIDED|95.0|14.6|28.4|||Linear model|||||28.4|14.6|<0.0001
91781966|NCT00606593|183443550|SUPERIORITY_OR_OTHER||Least square means treatment effect|34.7|||<|0.0001|TWO_SIDED|95.0|27.8|41.6|||Linear model|||||41.6|27.8|<0.0001
91781967|NCT00606593|183443550|SUPERIORITY_OR_OTHER||Least square means treatment effect|55.1|||<|0.0001|TWO_SIDED|95.0|48.2|62.0|||Linear model|||||62.0|48.2|<0.0001
91781968|NCT00607373|183443552|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Fifty-one patients were enrolled to allow for patient withdrawals and potential exclusions from analysis sets.||||<0.001
91781969|NCT00607373|183443553|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91781970|NCT00607373|183443555|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
91781971|NCT00607373|183443558|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
91781972|NCT00607373|183443560|SUPERIORITY_OR_OTHER|||||||0.013||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.013
91781973|NCT00607373|183443562|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.001
91590278|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.3|-0.4||||||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.3|
91590279|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.5|||=|0.1488|TWO_SIDED|95.0|-1.2|0.2|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.2|= 0.1488
91590280|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.3|||=|0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.0|= 0.0003
91590281|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.2|-0.3||||||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|
91590282|NCT03627767|183070533|SUPERIORITY||LSM difference|0.0|||=|0.9294|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.2|= 0.9294
91590283|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.1|||=|0.4081|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|= 0.4081
91590284|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|
91590285|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.4|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.1|< 0.0001
91590286|NCT03627767|183070533|SUPERIORITY||LSM difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.7|-2.0|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.0|-2.7|< 0.0001
91648148|NCT03125915|183188820|SUPERIORITY||Beta|-0.24||||0.83|TWO_SIDED|95.0|-2.39|1.91||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of CT video among those who completed the SUM.|||1.91|-2.39|0.83
91648149|NCT03125915|183188820|SUPERIORITY||Beta|3.13||||0.05|TWO_SIDED|95.0|-0.004|6.25||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of CT video among those who did not complete SUM.|||6.25|-0.004|0.05
91781974|NCT00607373|183443564|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.009
91781975|NCT00607373|183443566|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
91590287|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-0.9|-0.2||||||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-0.9|
91590288|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.7|||=|0.0035|TWO_SIDED|95.0|-1.2|-0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.2|= 0.0035
91590289|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.6|< 0.0001
91590290|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.8|-0.1||||||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.8|
91590291|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.7|||=|0.0136|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0136
91709118|NCT03035916|183311327|OTHER|||||||0.187|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.187
91781976|NCT00607373|183443568|SUPERIORITY_OR_OTHER|||||||0.328||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.328
91521383|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.852|TWO_SIDED|95.0|-38.0|46.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||46|-38|0.852
91521384|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.397|TWO_SIDED|95.0|-24.0|60.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||60|-24|0.397
91521385|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.494|TWO_SIDED|95.0|-28.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||58|-28|0.494
91521386|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.807|TWO_SIDED|95.0|-31.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||40|-31|0.807
91521387|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.386|TWO_SIDED|95.0|-20.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||51|-20|0.386
91521388|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.0||||0.089|TWO_SIDED|95.0|-4.8|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||67|-4.8|0.089
91521389|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.958|TWO_SIDED|95.0|-45.0|43.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||43|-45|0.958
91521390|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0||||0.766|TWO_SIDED|95.0|-37.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-37|0.766
91521391|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.06||95.0|-1.7|87.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||87|-1.7|0.060
91521392|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.678|TWO_SIDED|95.0|-53.0|35.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||35|-53|0.678
91521393|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0||||0.636|TWO_SIDED|95.0|-33.0|54.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||54|-33|0.636
91521394|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.094|TWO_SIDED|95.0|-6.5|83.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||83|-6.5|0.094
91521395|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0||||0.772|TWO_SIDED|95.0|-49.0|37.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||37|-49|0.772
91521396|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.0||||0.387|TWO_SIDED|95.0|-24.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||61|-24|0.387
91521397|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.0||||0.243|TWO_SIDED|95.0|-18.0|69.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||69|-18|0.243
91521398|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0||||0.398|TWO_SIDED|95.0|-62.0|25.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||25|-62|0.398
91521399|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0||||0.214|TWO_SIDED|95.0|-16.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||70|-16|0.214
91590292|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
91590293|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.4|||||TWO_SIDED|95.0|-0.8|0.0||||||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-0.8|
91590294|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.3|||=|0.2887|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.0|= 0.2887
91590295|NCT03627767|183070533|SUPERIORITY||LSM difference|-1.0|||=|0.0025|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.6|= 0.0025
91590296|NCT03627767|183070533|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-1.0|-0.2||||||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.0|
91590297|NCT03627767|183070534|SUPERIORITY||Difference in percentage|1.0|||=|0.4244|TWO_SIDED|95.0|-1.4|3.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.4|-1.4|= 0.4244
91590298|NCT03627767|183070534|SUPERIORITY||Difference in percentage|-0.3|||=|0.8092|TWO_SIDED|95.0|-3.1|2.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||2.4|-3.1|= 0.8092
91781977|NCT00607373|183443570|SUPERIORITY_OR_OTHER|||||||0.035||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.035
91781978|NCT04546672|183443591|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.58|TWO_SIDED|95.0|-31.1|55.4|||t-test, 2 sided|||||55.4|-31.1|0.58
91781979|NCT04546672|183443592|SUPERIORITY||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|9.2|15.4|||t-test, 2 sided|||||15.4|9.2|<0.001
91781980|NCT04546672|183443593|SUPERIORITY||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.9|6.2|||Fisher Exact|||||6.2|0.9|0.087
91781981|NCT04546672|183443594|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.48|TWO_SIDED|95.0|-26.4|12.6|||t-test, 2 sided|||||12.6|-26.4|0.48
91781982|NCT04546672|183443595|SUPERIORITY||Mean Difference (Final Values)|16.7||||0.02|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.02
91781983|NCT04546672|183443596|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.27|TWO_SIDED|95.0|-2.2|8.3|||t-test, 2 sided|||||8.3|-2.2|0.27
91590299|NCT03627767|183070534|SUPERIORITY||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-4.1|1.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.0|-4.1|
91781984|NCT01397968|183443598|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum|||||||<0.0001
91781985|NCT01397968|183443599|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
91781986|NCT02908672|183443600|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0224|TWO_SIDED|95.0|0.64|0.97|||Log Rank||Stratified Hazard Ratio|||0.97|0.64|0.0224
91781987|NCT02908672|183443601|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1607|TWO_SIDED|95.0|0.67|1.07|||Log Rank||Stratified Hazard Ratio|||1.07|0.67|0.1607
91781988|NCT02908672|183443602|SUPERIORITY||Difference in response rate|1.63||||0.6997|TWO_SIDED|95.0|-6.9|10.15|||Cochran-Mantel-Haenszel|||||10.15|-6.90|0.6997
91590300|NCT03627767|183070534|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.2|54.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||54.2|39.2|< 0.0001
91590301|NCT03627767|183070534|SUPERIORITY||Difference in percentage|63.6|||<|0.0001|TWO_SIDED|95.0|57.2|70.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||70.0|57.2|< 0.0001
91590302|NCT03627767|183070534|SUPERIORITY||Difference in percentage|17.0|||||TWO_SIDED|95.0|10.4|23.5||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.5|10.4|
91781989|NCT02908672|183443604|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1191|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.1191
91781990|NCT02908672|183443605|SUPERIORITY||Difference in Event Free Rate|8.2||||0.0693|TWO_SIDED|95.0|-0.65|17.04|||Z-test|||||17.04|-0.65|0.0693
91781991|NCT01424072|183443614|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.023
91590303|NCT03627767|183070534|SUPERIORITY||Difference in percentage|41.3|||<|0.0001|TWO_SIDED|95.0|33.9|48.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.7|33.9|< 0.0001
91590304|NCT03627767|183070534|SUPERIORITY||Difference in percentage|59.9|||<|0.0001|TWO_SIDED|95.0|53.1|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|53.1|< 0.0001
91590305|NCT03627767|183070534|SUPERIORITY||Difference in percentage|18.7|||||TWO_SIDED|95.0|10.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|10.8|
91590306|NCT03627767|183070534|SUPERIORITY||Difference in percentage|37.0|||<|0.0001|TWO_SIDED|95.0|29.6|44.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.4|29.6|< 0.0001
91590307|NCT03627767|183070534|SUPERIORITY||Difference in percentage|54.6|||<|0.0001|TWO_SIDED|95.0|47.6|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|47.6|< 0.0001
91590308|NCT03627767|183070534|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|9.4|26.0||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.0|9.4|
91590309|NCT03627767|183070534|SUPERIORITY||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|22.6|37.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.4|22.6|< 0.0001
91590310|NCT03627767|183070534|SUPERIORITY||Difference in percentage|50.9|||<|0.0001|TWO_SIDED|95.0|43.8|58.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.1|43.8|< 0.0001
91590311|NCT03627767|183070534|SUPERIORITY||Difference in percentage|21.1|||||TWO_SIDED|95.0|12.8|29.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.5|12.8|
91590312|NCT03627767|183070535|SUPERIORITY||Difference in percentage|1.4|||=|0.7232|TWO_SIDED|95.0|-6.1|8.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.8|-6.1|= 0.7232
91590313|NCT03627767|183070535|SUPERIORITY||Difference in percentage|-2.2|||=|0.5694|TWO_SIDED|95.0|-9.8|5.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-9.8|= 0.5694
91781992|NCT01424072|183443615|SUPERIORITY_OR_OTHER||||||,|0||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|This result was only to the domain Social Support.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days) and at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0,022
91590314|NCT03627767|183070535|SUPERIORITY||Difference in percentage|-3.7|||||TWO_SIDED|95.0|-11.2|3.8||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.8|-11.2|
91590315|NCT03627767|183070535|SUPERIORITY||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|22.2|35.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||35.8|22.2|< 0.0001
91590316|NCT03627767|183070535|SUPERIORITY||Difference in percentage|57.9|||<|0.0001|TWO_SIDED|95.0|51.2|64.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||64.5|51.2|< 0.0001
91590317|NCT03627767|183070535|SUPERIORITY||Difference in percentage|28.9|||||TWO_SIDED|95.0|20.8|37.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|20.8|
91781993|NCT01424072|183443616|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.039
91781994|NCT01424072|183443616|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANOVA|It was carried out the analysis of variance (ANOVA) among the groups at the follow up and then it was used the post hoc test.||Coping Strategy: Confrontation domain||||0.029
91781995|NCT02876601|183443618|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||||||0.408
91781996|NCT02876601|183443619|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
91781997|NCT02876601|183443620|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91781998|NCT02876601|183443621|SUPERIORITY|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||||||0.642
91781999|NCT02876601|183443622|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
91782000|NCT02876601|183443623|SUPERIORITY|||||||0.326|||||||Wilcoxon (Mann-Whitney)|||||||0.326
91590318|NCT03627767|183070535|SUPERIORITY||Difference in percentage|30.5|||<|0.0001|TWO_SIDED|95.0|23.9|37.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.2|23.9|< 0.0001
91590319|NCT03627767|183070535|SUPERIORITY||Difference in percentage|48.9|||<|0.0001|TWO_SIDED|95.0|42.1|55.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||55.6|42.1|< 0.0001
91590320|NCT03627767|183070535|SUPERIORITY||Difference in percentage|18.2|||||TWO_SIDED|95.0|9.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|9.8|
91590321|NCT03627767|183070535|SUPERIORITY||Difference in percentage|25.0|||<|0.0001|TWO_SIDED|95.0|18.4|31.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.5|18.4|< 0.0001
91590322|NCT03627767|183070535|SUPERIORITY||Difference in percentage|39.6|||<|0.0001|TWO_SIDED|95.0|32.7|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|32.7|< 0.0001
91590323|NCT03627767|183070535|SUPERIORITY||Difference in percentage|14.5|||||TWO_SIDED|95.0|6.3|22.8||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.8|6.3|
91590324|NCT03627767|183070535|SUPERIORITY||Difference in percentage|24.7|||<|0.0001|TWO_SIDED|95.0|18.1|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|18.1|< 0.0001
91590325|NCT03627767|183070535|SUPERIORITY||Difference in percentage|38.5|||<|0.0001|TWO_SIDED|95.0|31.6|45.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||45.3|31.6|< 0.0001
91590326|NCT03627767|183070535|SUPERIORITY||Difference in percentage|13.9|||||TWO_SIDED|95.0|5.6|22.3||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|5.6|
91590327|NCT03627767|183070543|SUPERIORITY||Difference in percentage|3.0|||=|0.4815|TWO_SIDED|95.0|-5.3|11.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||11.3|-5.3|= 0.4815
91590328|NCT03627767|183070543|SUPERIORITY||Difference in percentage|-1.8|||=|0.6748|TWO_SIDED|95.0|-10.3|6.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||6.6|-10.3|= 0.6748
91590329|NCT03627767|183070543|SUPERIORITY||Difference in percentage|-5.1|||||TWO_SIDED|95.0|-13.4|3.2||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.2|-13.4|
91648150|NCT03125915|183188821|SUPERIORITY||Beta|0.05||||0.9|TWO_SIDED|95.0|-2.3|2.41||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent intercept factor among those who did not view CT videos|||2.41|-2.30|0.90
91590330|NCT03627767|183070543|SUPERIORITY||Difference in percentage|24.0|||<|0.0001|TWO_SIDED|95.0|17.8|30.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.3|17.8|< 0.0001
91590331|NCT03627767|183070543|SUPERIORITY||Difference in percentage|42.3|||<|0.0001|TWO_SIDED|95.0|35.6|49.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.0|35.6|< 0.0001
91590332|NCT03627767|183070543|SUPERIORITY||Difference in percentage|18.4|||||TWO_SIDED|95.0|10.2|26.6||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||26.6|10.2|
91782001|NCT02876601|183443624|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||0.796
91782002|NCT02876601|183443625|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||||||0.918
91782003|NCT02876601|183443626|SUPERIORITY|||||||0.877|||||||Wilcoxon (Mann-Whitney)|||||||0.877
91782004|NCT02876601|183443627|SUPERIORITY|||||||0.423|||||||Wilcoxon (Mann-Whitney)|||||||0.423
91590333|NCT03627767|183070543|SUPERIORITY||Difference in percentage|24.6|||<|0.0001|TWO_SIDED|95.0|18.2|31.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.0|18.2|< 0.0001
91590334|NCT03627767|183070543|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.7|47.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.3|33.7|< 0.0001
91590335|NCT03627767|183070543|SUPERIORITY||Difference in percentage|15.9|||||TWO_SIDED|95.0|7.6|24.1||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.1|7.6|
91590336|NCT03627767|183070543|SUPERIORITY||Difference in percentage|18.8|||<|0.0001|TWO_SIDED|95.0|12.6|25.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.1|12.6|< 0.0001
91590337|NCT03627767|183070543|SUPERIORITY||Difference in percentage|34.5|||<|0.0001|TWO_SIDED|95.0|27.6|41.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.5|27.6|< 0.0001
91590338|NCT03627767|183070543|SUPERIORITY||Difference in percentage|15.6|||||TWO_SIDED|95.0|7.5|23.7||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.7|7.5|
91648151|NCT03125915|183188821|SUPERIORITY||Beta|0.26||||0.78|TWO_SIDED|95.0|-2.23|2.75||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT video on the latent intercept factor among those who did not view SUM.|||2.75|-2.23|0.78
91590339|NCT03627767|183070543|SUPERIORITY||Difference in percentage|18.7|||<|0.0001|TWO_SIDED|95.0|12.4|25.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.0|12.4|< 0.0001
91590340|NCT03627767|183070543|SUPERIORITY||Difference in percentage|32.3|||<|0.0001|TWO_SIDED|95.0|25.4|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.4|< 0.0001
91590341|NCT03627767|183070543|SUPERIORITY||Difference in percentage|13.7|||||TWO_SIDED|95.0|5.6|21.7||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.7|5.6|
91709119|NCT03035916|183311327|OTHER|||||||0.112|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.112
91590342|NCT03627767|183070544|SUPERIORITY||LSM difference|0.1|||=|0.7373|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.5|= 0.7373
91590343|NCT03627767|183070544|SUPERIORITY||LSM difference|-0.1|||=|0.8092|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.7|= 0.8092
91590344|NCT03627767|183070544|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.8|0.4||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.8|
91590345|NCT03627767|183070544|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.1|-4.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.0|-6.1|< 0.0001
91590346|NCT03627767|183070544|SUPERIORITY||LSM difference|-6.6|||<|0.0001|TWO_SIDED|95.0|-7.6|-5.5|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.5|-7.6|< 0.0001
91590347|NCT03627767|183070544|SUPERIORITY||LSM difference|-1.5|||||TWO_SIDED|95.0|-2.4|-0.6||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.4|
91590348|NCT03627767|183070544|SUPERIORITY||LSM difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.7|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.7|-5.3|< 0.0001
91648152|NCT03125915|183188821|SUPERIORITY||Beta|-1.18||||0.53|TWO_SIDED|95.0|-4.86|2.51||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT video on the latent intercept.|||2.51|-4.86|0.53
91648153|NCT03125915|183188821|SUPERIORITY||Beta|1.83||||0.14|TWO_SIDED|95.0|-0.62|4.29||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent slope factor among those who did not view CT Videos.|||4.29|-0.62|0.14
91782005|NCT02876601|183443628|SUPERIORITY|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||||||0.938
91782006|NCT00354432|183443633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3455|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.||The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.||||.3455
91782007|NCT00354432|183443634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|||Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.||||0.2081
91782008|NCT03863080|183443643|SUPERIORITY||Least square mean difference|-56.33|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Total IgG levels has been presented.|||||<0.0001
91782009|NCT03863080|183443643|SUPERIORITY||Least square mean difference|-74.49|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Total IgG levels has been presented.|||||<0.0001
91782010|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-62.7|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 1 subclass has been presented.|||||<0.001
91782011|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-73.0|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 1 subclass has been presented.|||||<0.001
91782012|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-52.5|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 2 subclass has been presented.|||||<0.001
91782013|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-61.4|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 2 subclass has been presented.|||||<0.001
91782014|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-66.1|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 3 subclass has been presented.|||||<0.001
91782015|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-80.8|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 3 subclass has been presented.|||||<0.001
91782016|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-44.9|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 4 subclass has been presented.|||||<0.001
91590349|NCT03627767|183070544|SUPERIORITY||LSM difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.9|-6.4|< 0.0001
91709120|NCT03035916|183311328|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
91782017|NCT03863080|183443644|SUPERIORITY||Least square mean difference|-61.6|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 4 subclass has been presented.|||||<0.001
91648154|NCT03125915|183188821|SUPERIORITY||Beta|0.35||||0.76|TWO_SIDED|95.0|-2.02|2.72||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT Video on latent slope factor among those who did not complete the SUM.|||2.72|-2.02|0.76
91648155|NCT03125915|183188821|SUPERIORITY||Beta|-1.28||||0.45|TWO_SIDED|95.0|-4.62|2.06||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor.|||2.06|-4.62|0.45
91782018|NCT03863080|183443645|SUPERIORITY||Least square mean difference|-62.58||||0.0009|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Anti-AChR-IgG has been presented.|||||0.0009
91782019|NCT03863080|183443645|SUPERIORITY||Least square mean difference|-101.2|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Anti-AChR-IgG has been presented.|||||<0.0001
91782020|NCT05307692|183443677|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.47||0.308|TWO_SIDED|80.0|-3.41|0.39|||Mixed model repeated measures|||||0.39|-3.41|0.308
91709121|NCT03035916|183311328|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
91709122|NCT03035916|183311328|OTHER|||||||0.314|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.314
91709123|NCT03035916|183311328|OTHER|||||||0.003|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.003
91590350|NCT03627767|183070544|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.1|
91590351|NCT03627767|183070544|SUPERIORITY||LSM difference|-1.9|||=|0.015|TWO_SIDED|95.0|-3.5|-0.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.5|= 0.0150
91590352|NCT03627767|183070544|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-4.7|< 0.0001
91590353|NCT03627767|183070544|SUPERIORITY||LSM difference|-1.3|||||TWO_SIDED|95.0|-2.3|-0.3||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.3|
91590354|NCT03627767|183070544|SUPERIORITY||LSM difference|-0.8|||=|0.3616|TWO_SIDED|95.0|-2.4|0.9|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-2.4|= 0.3616
91590355|NCT03627767|183070544|SUPERIORITY||LSM difference|-2.7|||=|0.0012|TWO_SIDED|95.0|-4.3|-1.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-4.3|= 0.0012
91590356|NCT03627767|183070544|SUPERIORITY||LSM difference|-1.9|||||TWO_SIDED|95.0|-3.0|-0.8||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-3.0|
91590357|NCT03627767|183070545|SUPERIORITY||LSM difference|0.6|||=|0.3339|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.8|-0.6|= 0.3339
91590358|NCT03627767|183070545|SUPERIORITY||LSM difference|0.5|||=|0.4653|TWO_SIDED|95.0|-0.8|1.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-0.8|= 0.4653
91590359|NCT03627767|183070545|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.1|-1.3|
91590360|NCT03627767|183070545|SUPERIORITY||LSM difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.3|-6.2|< 0.0001
91590361|NCT03627767|183070545|SUPERIORITY||LSM difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.2|-4.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.3|-8.2|< 0.0001
91590362|NCT03627767|183070545|SUPERIORITY||LSM difference|-2.0|||||TWO_SIDED|95.0|-3.6|-0.3||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-3.6|
91590363|NCT03627767|183070545|SUPERIORITY||LSM difference|0.1|||=|0.9083|TWO_SIDED|95.0|-1.8|2.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||2.1|-1.8|= 0.9083
91590364|NCT03627767|183070545|SUPERIORITY||LSM difference|-1.1|||=|0.2439|TWO_SIDED|95.0|-3.0|0.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|-3.0|= 0.2439
91590365|NCT03627767|183070545|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-2.6|
91782021|NCT05307692|183443678|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.42||0.282|TWO_SIDED|80.0|-3.33|0.29|||Mixed model repeated measures|||||0.29|-3.33|0.282
91782022|NCT05232682|183443710|OTHER||F-test|2.41||||0.1183|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1183
91782023|NCT05232682|183443711|OTHER||F-test|0.07||||0.9308|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.9308
91782024|NCT05232682|183443712|OTHER||F-test|2.1||||0.1517|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1517
91782025|NCT05232682|183443713|OTHER||F-test|0.14||||0.8747|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.8747
91782026|NCT05232682|183443714|OTHER||F-test|1.19||||0.3269|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3269
91782027|NCT05232682|183443715|OTHER||F-test|1.14||||0.3411|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3411
91782028|NCT00905164|183443716|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|99.5|||||TWO_SIDED|90.0|94.27|105.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||105.03|94.27|
91782029|NCT00905164|183443717|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|100.13||||||90.0|97.6|102.72|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.72|97.60|
91782030|NCT00905164|183443718|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|101.53||||||90.0|99.01|104.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.12|99.01|
91782031|NCT01077050|183443727|SUPERIORITY_OR_OTHER||Sensitivity to Melanoma|96.6|||||ONE_SIDED|95.0|94.2|||The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.|Clopper-Pearson 1-sided||||||94.2|
91782032|NCT01077050|183443727|SUPERIORITY_OR_OTHER||Sensitivity to Basal Cell Carcinoma|100.0|||||TWO_SIDED|95.0|92.6|100.0|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for Basal Cell Carcinoma||||100|92.6|
91782033|NCT01077050|183443727|SUPERIORITY_OR_OTHER||Observed sensitivity for squamous cell c|93.3|||||TWO_SIDED|95.0|68.1|99.8|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for squamous cell carcinoma||||99.8|68.1|
91782034|NCT01077050|183443727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.0|||<|0.0001|TWO_SIDED|95.0|6.6|25.5|||Mixed Models Analysis|Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.||||25.5|6.6|<0.0001
91782035|NCT00684060|183443729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|8.6|<|0.05|TWO_SIDED|95.0|-7.05|0.95||Threshold 0.05|t-test, 2 sided|No adjustment for multiple comparisons||Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||.95|-7.05|<0.05
91782036|NCT00684060|183443730|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.05||95.0|0.08|1.17|||Fisher Exact|||comparison of the proportion of events in patients in the active group to those in patients in the control group||1.17|0.08|<0.05
91782037|NCT00684060|183443731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|17.2|<|0.05|TWO_SIDED|95.0|-9.3|6.8|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||6.8|-9.3|<0.05
91782038|NCT00684060|183443732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|21.8|<|0.05|TWO_SIDED|95.0|-9.5|10.9|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||10.9|-9.5|<0.05
91782039|NCT00684060|183443733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|14.2|<|0.05|TWO_SIDED|95.0|-4.1|9.2|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||9.2|-4.1|<0.05
91782040|NCT00684060|183443734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|17.7|<|0.05||95.0|-9.9|6.9|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||6.9|-9.9|<0.05
91782041|NCT00684060|183443735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|4.4|<|0.05|TWO_SIDED|95.0|-2.8|1.3||Unadjusted|t-test, 2 sided|||Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||1.3|-2.8|<0.05
91782042|NCT00684060|183443736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.05||95.0|-6.0|0.8|||t-test, 2 sided|||Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||0.8|-6.0|<0.05
91782043|NCT02641561|183443756|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
91782044|NCT00702715|183443757|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence|Median Difference (Final Values)|78.0|||||TWO_SIDED|95.0|36.0|143.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||143.0|36.0|
91782045|NCT00702715|183443758|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|68.0|||||TWO_SIDED|95.0|36.0|120.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||120.0|36.0|
91590366|NCT03627767|183070545|SUPERIORITY||LSM difference|-0.3|||=|0.7405|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-2.4|= 0.7405
91590367|NCT03627767|183070545|SUPERIORITY||LSM difference|-2.1|||=|0.041|TWO_SIDED|95.0|-4.1|-0.1|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-4.1|= 0.0410
91590368|NCT03627767|183070545|SUPERIORITY||LSM difference|-1.7|||||TWO_SIDED|95.0|-3.1|-0.4||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.1|
91590369|NCT03627767|183070545|SUPERIORITY||LSM difference|-1.0|||=|0.4026|TWO_SIDED|95.0|-3.5|1.4|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.4|-3.5|= 0.4026
91590370|NCT03627767|183070545|SUPERIORITY||LSM difference|-1.9|||=|0.0944|TWO_SIDED|95.0|-4.2|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-4.2|= 0.0944
91590371|NCT03627767|183070545|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-2.5|0.7||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-2.5|
91590372|NCT03627767|183070546|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.211|0.341||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate p-value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).||0.341|0.211|< 0.0001
91648156|NCT03125915|183188822|SUPERIORITY||Beta|-0.75||||0.02|TWO_SIDED|95.0|-1.39|-0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who viewed CT videos.|||-0.11|-1.39|0.02
91648157|NCT03125915|183188822|SUPERIORITY||Beta|-0.49||||0.1|TWO_SIDED|95.0|-1.07|0.09||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view CT videos.|||0.09|-1.07|0.10
91709124|NCT03035916|183311328|OTHER|||||||0.367|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.367
91782046|NCT00702715|183443759|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|60.0|||||TWO_SIDED|95.0|31.0|103.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||103.0|31.0|
91782047|NCT00689260|183443760|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Wilcoxon (Mann-Whitney)|||P-Value based on two-sided Wilcoxon rank-sum test for difference in medians between log aware and log unaware||||0.908
91782048|NCT02563067|183443788|SUPERIORITY||Rate Ratio|0.69||||0.059|TWO_SIDED|95.0|0.5|0.96|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.96|0.50|0.059
91782049|NCT02563067|183443788|SUPERIORITY||Rate Ratio|0.72||||0.114|TWO_SIDED|95.0|0.52|1.01|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.01|0.52|0.114
91590373|NCT03627767|183070546|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.136||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.136|0.070|< 0.0001
91590374|NCT03627767|183070546|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.255|0.516||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.516|0.255|< 0.0001
91590375|NCT03627767|183070547|SUPERIORITY||LSM difference|0.1|||=|0.7556|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7556
91590376|NCT03627767|183070547|SUPERIORITY||LSM difference|0.1|||=|0.7484|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7484
91709125|NCT03035916|183311328|OTHER|||||||0.031|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.031
91709126|NCT03035916|183311328|OTHER|||||||0.009|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.009
91782050|NCT02563067|183443789|SUPERIORITY||Mean Difference (Net)|0.15||||0.369|TWO_SIDED|95.0|-0.02|0.32|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.32|-0.02|0.369
91590377|NCT03627767|183070547|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.5|
91782051|NCT02563067|183443789|SUPERIORITY||Mean Difference (Net)|0.13||||0.824|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.30|-0.04|0.824
91590378|NCT03627767|183070547|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
91590379|NCT03627767|183070547|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.9|< 0.0001
91590380|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.7|
91590381|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.6|||=|0.0242|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0242
91590382|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.9|||=|0.0012|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.4|= 0.0012
91782052|NCT02563067|183443790|SUPERIORITY||Mean Difference (Net)|-0.17||||0.369|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.01|-0.36|0.369
91590383|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.6|
91590384|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.6|||=|0.124|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.3|= 0.1240
91590385|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.9|||=|0.0107|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.6|= 0.0107
91782053|NCT02563067|183443790|SUPERIORITY||Mean Difference (Net)|-0.09||||0.824|TWO_SIDED|95.0|-0.28|0.1|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.10|-0.28|0.824
91590386|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.8|
91590387|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.4|||=|0.3139|TWO_SIDED|95.0|-1.1|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.1|= 0.3139
91590388|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.6|||=|0.0853|TWO_SIDED|95.0|-1.3|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.3|= 0.0853
91590389|NCT03627767|183070547|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.7|0.2||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.7|
91590390|NCT03627767|183070548|SUPERIORITY||LSM difference|0.4|||=|0.0674|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|0.0|= 0.0674
91590391|NCT03627767|183070548|SUPERIORITY||LSM difference|0.3|||=|0.1437|TWO_SIDED|95.0|-0.1|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.1|= 0.1437
91590392|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.5|
91590393|NCT03627767|183070548|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
91590394|NCT03627767|183070548|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
91590395|NCT03627767|183070548|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.4|
91521400|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.526|TWO_SIDED|95.0|-30.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||58|-30|0.526
91590396|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.4|||=|0.1136|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.0|= 0.1136
91590397|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.6|||=|0.0276|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.1|= 0.0276
91590398|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.2||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.5|
91590399|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.9|||=|0.0108|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.5|= 0.0108
91590400|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.6|||=|0.0677|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-1.3|= 0.0677
91590401|NCT03627767|183070548|SUPERIORITY||LSM difference|0.3|||||TWO_SIDED|95.0|-0.2|0.7||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.2|
91590402|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.5|||=|0.132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.1|= 0.1320
91590403|NCT03627767|183070548|SUPERIORITY||LSM difference|-0.3|||=|0.2975|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.9|= 0.2975
91590404|NCT03627767|183070548|SUPERIORITY||LSM difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.2|
91590405|NCT03627767|183070549|SUPERIORITY||LSM difference|-0.4|||=|0.3531|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-1.3|= 0.3531
91590406|NCT03627767|183070549|SUPERIORITY||LSM difference|0.0|||=|0.9282|TWO_SIDED|95.0|-0.8|0.9|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-0.8|= 0.9282
91590407|NCT03627767|183070549|SUPERIORITY||LSM difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.3|-0.4|
91782054|NCT02563067|183443791|SUPERIORITY||Mean Difference (Net)|0.068||||0.369|TWO_SIDED|95.0|-0.018|0.154|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.154|-0.018|0.369
91782055|NCT02563067|183443791|SUPERIORITY||Mean Difference (Net)|0.038||||0.824|TWO_SIDED|95.0|-0.048|0.124|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.124|-0.048|0.824
91782056|NCT02563067|183443792|SUPERIORITY||Rate Ratio|0.82||||0.369|TWO_SIDED|95.0|0.62|1.07|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.07|0.62|0.369
91782057|NCT02563067|183443792|SUPERIORITY||Rate Ratio|0.76||||0.348|TWO_SIDED|95.0|0.58|1.0|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.00|0.58|0.348
91782058|NCT02563067|183443793|SUPERIORITY||Mean Difference (Net)|0.07||||0.824|TWO_SIDED|95.0|-0.07|0.21|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.21|-0.07|0.824
91782059|NCT02563067|183443793|SUPERIORITY||Mean Difference (Net)|0.12||||0.824|TWO_SIDED|95.0|-0.02|0.26|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.26|-0.02|0.824
91782060|NCT02563067|183443794|SUPERIORITY||Mean Difference (Net)|-0.12||||0.824|TWO_SIDED|95.0|-0.28|0.03|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.03|-0.28|0.824
91782061|NCT02563067|183443794|SUPERIORITY||Mean Difference (Net)|-0.07||||0.824|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.08|-0.23|0.824
91782062|NCT02563067|183443795|SUPERIORITY||Mean Difference (Net)|0.05||||0.369|TWO_SIDED|95.0|-0.019|0.119|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.119|-0.019|0.369
91782063|NCT02563067|183443795|SUPERIORITY||Mean Difference (Net)|0.061||||0.595|TWO_SIDED|95.0|-0.008|0.13|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.130|-0.008|0.595
91782064|NCT00826462|183443820|OTHER||||||<|0.01|||||||linear generalized estimating equations||||A linear GEE regression model adjusted for the significant covariates at p \< 0.05 from the univariate GEE logistic regression models calculated for success|||<0.01
91782065|NCT00826462|183443820|OTHER||||||<|0.01|||||||linear generalized estimating equations|||||||<0.01
91782066|NCT00826462|183443824|OTHER||||||||||||||||||linear generalized estimating equations (GEE) regression model adjusted for significant covariates; between groups estimated odds ratio (OR) for no pain on two isometric movements using logistic GEE regression model adjusted for significant covariates; 99 % confidence intervals|||
91790187|NCT02660138|183459524|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|110.57|||<|0.0001|TWO_SIDED|95.0|70.17|150.98|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||150.98|70.17|<0.0001
91590408|NCT03627767|183070549|SUPERIORITY||LSM difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.3|-5.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.0|-7.3|< 0.0001
91590409|NCT03627767|183070549|SUPERIORITY||LSM difference|-9.2|||<|0.0001|TWO_SIDED|95.0|-10.3|-8.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-8.1|-10.3|< 0.0001
91590410|NCT03627767|183070549|SUPERIORITY||LSM difference|-3.1|||||TWO_SIDED|95.0|-4.0|-2.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.1|-4.0|
91590411|NCT03627767|183070549|SUPERIORITY||LSM difference|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.9|-6.2|< 0.0001
91590412|NCT03627767|183070549|SUPERIORITY||LSM difference|-6.7|||<|0.0001|TWO_SIDED|95.0|-8.3|-5.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.1|-8.3|< 0.0001
91590413|NCT03627767|183070549|SUPERIORITY||LSM difference|-2.1|||||TWO_SIDED|95.0|-3.3|-0.9||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-3.3|
91590414|NCT03627767|183070549|SUPERIORITY||LSM difference|-2.6|||=|0.0082|TWO_SIDED|95.0|-4.5|-0.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-4.5|= 0.0082
91590415|NCT03627767|183070549|SUPERIORITY||LSM difference|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.6|-7.4|< 0.0001
91590416|NCT03627767|183070549|SUPERIORITY||LSM difference|-2.9|||||TWO_SIDED|95.0|-4.2|-1.6||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.6|-4.2|
91590417|NCT03627767|183070549|SUPERIORITY||LSM difference|-2.4|||=|0.0313|TWO_SIDED|95.0|-4.5|-0.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-4.5|= 0.0313
91709127|NCT03035916|183311328|OTHER|||||||0.873|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.873
91590418|NCT03627767|183070549|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.0|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.0|-7.1|< 0.0001
91590419|NCT03627767|183070549|SUPERIORITY||LSM difference|-2.7|||||TWO_SIDED|95.0|-4.1|-1.3||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-4.1|
91709128|NCT03035916|183311328|OTHER|||||||0.026|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.026
91709129|NCT03035916|183311328|OTHER|||||||0.411|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.411
91590420|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.1|||=|0.4832|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.4|= 0.4832
91590421|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.1|||=|0.6553|TWO_SIDED|95.0|-0.3|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.3|= 0.6553
91590422|NCT03627767|183070550|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.2|
91590423|NCT03627767|183070550|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-1.5|< 0.0001
91590424|NCT03627767|183070550|SUPERIORITY||LSM difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.7|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.2|< 0.0001
91590425|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.7|||||TWO_SIDED|95.0|-0.9|-0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-0.9|
91590426|NCT03627767|183070550|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.0|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.0|-1.7|< 0.0001
91590427|NCT03627767|183070550|SUPERIORITY||LSM difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.8|-2.5|< 0.0001
91590428|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
91590429|NCT03627767|183070550|SUPERIORITY||LSM difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.4|< 0.0001
91590430|NCT03627767|183070550|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.2|< 0.0001
91590431|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
91590432|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.8|||=|0.002|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|= 0.0020
91590433|NCT03627767|183070550|SUPERIORITY||LSM difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.2|< 0.0001
91590434|NCT03627767|183070550|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-1.3|-0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.3|
91590435|NCT02953639|183070558|SUPERIORITY||Treatment Difference|-0.36||||0.73|TWO_SIDED|90.0|-2.11|1.38|||Mixed Models Analysis|||Week 12 Day 84||1.38|-2.11|0.730
91590436|NCT02953639|183070558|SUPERIORITY||Treatment Difference|0.28||||0.793|TWO_SIDED|90.0|-1.47|2.02|||Mixed Models Analysis|||Week 24 Day 168||2.02|-1.47|0.793
91648158|NCT03125915|183188822|SUPERIORITY||Beta|-0.15||||0.63|TWO_SIDED|95.0|-0.77|0.47||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who completed SUM.|||0.47|-0.77|0.63
91590437|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.91||||0.556|TWO_SIDED|90.0|-3.46|1.64|||Mixed Models Analysis|||Week 12 Day 84 (Attention/Vigilance)||1.64|-3.46|0.556
91590438|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.27||||0.848|TWO_SIDED|90.0|-2.59|2.05|||Mixed Models Analysis|||Week 24 Day 168 (Attention/Vigilance)||2.05|-2.59|0.848
91590439|NCT02953639|183070559|SUPERIORITY||Treatment Difference|0.04||||0.973|TWO_SIDED|90.0|-2.08|2.16|||Mixed Models Analysis|||Week 12 Day 84 (Reasoning and Problem Solving)||2.16|-2.08|0.973
91590440|NCT02953639|183070559|SUPERIORITY||Treatment Difference|0.57||||0.651|TWO_SIDED|90.0|-1.53|2.67|||Mixed Models Analysis|||Week 24 Day 168 (Reasoning and Problem Solving)||2.67|-1.53|0.651
91590441|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-1.44||||0.35|TWO_SIDED|90.0|-3.89|1.08|||Mixed Models Analysis|||Week 12 Day 84 (Social Cognition)||1.08|-3.89|0.350
91590442|NCT02953639|183070559|SUPERIORITY||Treatment Difference|2.18||||0.121|TWO_SIDED|90.0|-0.14|4.5|||Mixed Models Analysis|||Week 24 Day 168 (Social Cognition)||4.50|-0.14|0.121
91590443|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.13||||0.911|TWO_SIDED|90.0|-2.1|1.83|||Mixed Models Analysis|||Week 12 Day 84 (Speed of Processing)||1.83|-2.10|0.911
91590444|NCT02953639|183070559|SUPERIORITY||Treatment Difference|0.02||||0.987|TWO_SIDED|90.0|-1.99|2.03|||Mixed Models Analysis|||Week 24 Day 168 (Speed of Processing)||2.03|-1.99|0.987
91590445|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.34||||0.803|TWO_SIDED|90.0|-2.62|1.93|||Mixed Models Analysis|||Week 12 Day 84 (Verbal Learning)||1.93|-2.62|0.803
91590446|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.94||||0.502|TWO_SIDED|90.0|-3.26|1.38|||Mixed Models Analysis|||Week 24 Day 168 (Verbal Learning)||1.38|-3.26|0.502
91590447|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.11||||0.945|TWO_SIDED|90.0|-2.74|2.52|||Mixed Models Analysis|||Week 12 Day 84 (Visual Learning)||2.52|-2.74|0.945
91590448|NCT02953639|183070559|SUPERIORITY||Treatment Difference|1.11||||0.488|TWO_SIDED|90.0|-1.54|3.76|||Mixed Models Analysis|||Week 24 Day 168 (Visual Learning)||3.76|-1.54|0.488
91590449|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-1.37||||0.262|TWO_SIDED|90.0|-3.38|0.64|||Mixed Models Analysis|||Week 12 Day 84 (Working Memory)||0.64|-3.38|0.262
91590450|NCT02953639|183070559|SUPERIORITY||Treatment Difference|-0.89||||0.489|TWO_SIDED|90.0|-3.01|1.23|||Mixed Models Analysis|||Week 24 Day 168 (Working Memory)||1.23|-3.01|0.489
91590451|NCT02953639|183070560|SUPERIORITY||Treatment Difference|-1.63||||0.211|TWO_SIDED|90.0|-3.78|0.52|||Mixed Models Analysis|||Week 12 Day 84 (VPA I total raw score)||0.52|-3.78|0.211
91590452|NCT02953639|183070560|SUPERIORITY||Treatment Difference|0.35||||0.787|TWO_SIDED|90.0|-1.81|2.52|||Mixed Models Analysis|||Week 24 Day 168 (VPA I total raw score)||2.52|-1.81|0.787
91590453|NCT02953639|183070560|SUPERIORITY||Treatment Difference|0.28||||0.477|TWO_SIDED|90.0|-0.37|0.94|||Mixed Models Analysis|||Week 12 Day 84 (VPA II total raw score)||0.94|-0.37|0.477
91590454|NCT02953639|183070560|SUPERIORITY||Treatment Difference|0.91||||0.028|TWO_SIDED|90.0|0.23|1.58|||Mixed Models Analysis|||Week 24 Day 168 (VPA II total raw score)||1.58|0.23|0.028
91590455|NCT02953639|183070560|SUPERIORITY||Treatment Difference|-0.3||||0.683|TWO_SIDED|90.0|-1.51|0.91|||Mixed Models Analysis|||Week 12 Day 84 (VPA II recognition total raw score)||0.91|-1.51|0.683
91590456|NCT02953639|183070560|SUPERIORITY||Treatment Difference|0.04||||0.954|TWO_SIDED|90.0|-1.13|1.22|||Mixed Models Analysis|||Week 24 Day 168 (VPA II recognition total raw score)||1.22|-1.13|0.954
91590457|NCT02953639|183070561|SUPERIORITY||Treatment Difference|1.45||||0.164|TWO_SIDED|90.0|-0.27|3.17|||Mixed Models Analysis|||Week 12 Day 84 (LM I)||3.17|-0.27|0.164
91590458|NCT02953639|183070561|SUPERIORITY||Treatment Difference|0.56||||0.559|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||Week 24 Day 168 (LM I)||2.14|-1.02|0.559
91590459|NCT02953639|183070561|SUPERIORITY||Treatment Difference|0.12||||0.912|TWO_SIDED|90.0|-1.7|1.94|||Mixed Models Analysis|||Week 12 Day 84 (LM II)||1.94|-1.70|0.912
91590460|NCT02953639|183070561|SUPERIORITY||Treatment Difference|-0.36||||0.706|TWO_SIDED|90.0|-1.93|1.22|||Mixed Models Analysis|||Week 24 Day 168 (LM II)||1.22|-1.93|0.706
91590461|NCT02953639|183070562|SUPERIORITY||Treatment Difference|1.04||||0.527|TWO_SIDED|90.0|0.94|1.15|||Mixed Models Analysis|||Week 12 Day 84||1.15|0.94|0.527
91648159|NCT03125915|183188822|SUPERIORITY||Beta|-0.41||||0.19|TWO_SIDED|95.0|-1.01|0.2||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who did not complete SUM.|||0.20|-1.01|0.19
91590462|NCT02953639|183070562|SUPERIORITY||Treatment Difference|1.04||||0.636|TWO_SIDED|90.0|0.92|1.17|||Mixed Models Analysis|||Week 24 Day 168||1.17|0.92|0.636
91590463|NCT02953639|183070563|SUPERIORITY||Treatment Difference|-1.36||||0.323|TWO_SIDED|90.0|-3.63|0.91|||Mixed Models Analysis|||Week 12 Day 84||0.91|-3.63|0.323
91590464|NCT02953639|183070563|SUPERIORITY||Treatment Difference|-0.95||||0.579|TWO_SIDED|90.0|-3.77|1.88|||Mixed Models Analysis|||Week 24 Day 168||1.88|-3.77|0.579
91648160|NCT03125915|183188822|SUPERIORITY||Beta|-0.64||||0.01|TWO_SIDED|95.0|-1.13|-0.15||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of SUM among those who completed the CT video.|||-0.15|-1.13|0.01
91590465|NCT02953639|183070564|SUPERIORITY||Treatment Difference|-0.67||||0.493|TWO_SIDED|90.0|-2.27|0.94|||Mixed Models Analysis|||Week 12 Day 84||0.94|-2.27|0.493
91590466|NCT02953639|183070564|SUPERIORITY||Treatment Difference|-0.12||||0.926|TWO_SIDED|90.0|-2.32|2.07|||Mixed Models Analysis|||Week 24 Day 168||2.07|-2.32|0.926
91590467|NCT02953639|183070565|SUPERIORITY||Treatment Difference|-0.02||||0.839|TWO_SIDED|90.0|-0.22|0.17|||Mixed Models Analysis|||Week 12 Day 84||0.17|-0.22|0.839
91590468|NCT02953639|183070565|SUPERIORITY||Treatment Difference|-0.06||||0.625|TWO_SIDED|90.0|-0.27|0.15|||Mixed Models Analysis|||Week 24 Day 168||0.15|-0.27|0.625
91590469|NCT02953639|183070566|SUPERIORITY||Treatment Difference|-0.03||||0.865|TWO_SIDED|90.0|-0.28|0.23|||Mixed Models Analysis|||Week 12 Day 84||0.23|-0.28|0.865
91590470|NCT02953639|183070566|SUPERIORITY||Treatment Difference|-0.01||||0.964|TWO_SIDED|90.0|-0.31|0.29|||Mixed Models Analysis|||Week 24 Day 168||0.29|-0.31|0.964
91590471|NCT02953639|183070567|SUPERIORITY||Treatment Difference|3.27||||0.142|TWO_SIDED|90.0|-0.4|6.95|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Cognition \& Vitality Score)||6.95|-0.40|0.142
91590472|NCT02953639|183070567|SUPERIORITY||Treatment Difference|-2.32||||0.416|TWO_SIDED|90.0|-7.04|2.4|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Cognition \& Vitality Score)||2.40|-7.04|0.416
91590473|NCT02953639|183070567|SUPERIORITY||Treatment Difference|1.98||||0.394|TWO_SIDED|90.0|-1.86|5.83|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Psychosocial Score)||5.83|-1.86|0.394
91590474|NCT02953639|183070567|SUPERIORITY||Treatment Difference|0.71||||0.776|TWO_SIDED|90.0|-3.44|4.87|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Psychosocial Score)||4.87|-3.44|0.776
91590475|NCT02953639|183070567|SUPERIORITY||Treatment Difference|2.43||||0.254|TWO_SIDED|90.0|-1.09|5.94|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Total Score)||5.94|-1.09|0.254
91590476|NCT02953639|183070567|SUPERIORITY||Treatment Difference|-0.57||||0.816|TWO_SIDED|90.0|-4.64|3.5|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Total Score)||3.50|-4.64|0.816
91590477|NCT03034460|183070580|SUPERIORITY||||||=|0.158|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \[n=48\] versus CD5024 1% Cream Matched Placebo \[n=48\]).||||= 0.158
91590478|NCT03034460|183070580|SUPERIORITY||||||=|0.002|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \[n=22\] versus Adapalene Benzoyl Peroxyde Matched Placebo \[n=22\]).||||= 0.002
91590479|NCT02294682|183070591|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|97.0|||||ONE_SIDED|95.0|85.1||||||GSK2140944 1500 mg||||85.1|
91590480|NCT02294682|183070591|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|95.0|||||ONE_SIDED|95.0|84.7||||||GSK2140944 3000 mg||||84.7|
91590481|NCT01516970|183070609|SUPERIORITY_OR_OTHER|||||||0.2434||||||The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel \[CMH\]-Test) with p-value: 0.2434|Cochran-Mantel-Haenszel|||||||0.2434
91590482|NCT01516970|183070610|SUPERIORITY_OR_OTHER|||||||0.8839||||||The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.|Fisher Exact|||||||0.8839
91590483|NCT01002456|183070614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.1|3.2|||||Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.|||3.2|1.1|
91590484|NCT00744211|183070623|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<0.05; Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||<0.05
91590485|NCT00744211|183070624|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||0.001
91590486|NCT00744211|183070625|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91590487|NCT00744211|183070626|EQUIVALENCE|Chi-square tests for differences between groups.||||||0.015||||||P-value is associated with the hematological/lymphatic adverse event.|Chi-squared|||||||0.015
91590488|NCT00038727|183070651|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.81|1.28|||Log Rank|||||1.28|0.81|0.87
91590489|NCT00038727|183070651|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||||1.25|0.79|0.95
91590490|NCT04178967|183070683|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
91590491|NCT04178967|183070684|SUPERIORITY||Risk Difference (RD)|33.3|||<|1e-06|TWO_SIDED|95.0|24.4|42.2|||Cochran-Mantel-Haenszel|||||42.2|24.4|<0.000001
91590492|NCT04178967|183070685|SUPERIORITY||Risk Difference (RD)|0.7||||0.308463|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.308463
91590493|NCT04178967|183070686|SUPERIORITY||Risk Difference (RD)|8.1||||0.001607|TWO_SIDED|95.0|4.1|12.0|||Cochran-Mantel-Haenszel|||||12.0|4.1|0.001607
91590494|NCT04178967|183070687|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
91590495|NCT04178967|183070688|SUPERIORITY||Risk Difference (RD)|20.7||||8e-06|TWO_SIDED|95.0|13.3|28.1|||Cochran-Mantel-Haenszel|||||28.1|13.3|0.000008
91590496|NCT04178967|183070689|SUPERIORITY||LS Mean Difference (Final Values)|-27.53|||<|1e-06|TWO_SIDED|95.0|-34.9|-20.2|||ANCOVA|||||-20.2|-34.9|<0.000001
91590497|NCT04178967|183070690|SUPERIORITY||Risk Difference (RD)|28.3|||<|1e-06|TWO_SIDED|95.0|20.0|36.5|||Cochran-Mantel-Haenszel|||||36.5|20.0|<0.000001
91590498|NCT04178967|183070691|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.0|38.4|||Cochran-Mantel-Haenszel|||||38.4|21.0|<0.000001
91590499|NCT04178967|183070692|SUPERIORITY||LS Mean Difference (Final Values)|-33.57|||<|1e-06|TWO_SIDED|95.0|-41.2|-26.0|||ANCOVA|||||-26.0|-41.2|<0.000001
91590500|NCT04178967|183070693|SUPERIORITY||LS Mean Difference (Final Values)|-16.2|||<|1e-06|TWO_SIDED|95.0|-20.3|-12.0|||Mixed Models Analysis|||||-12.0|-20.3|<0.000001
91590501|NCT04178967|183070694|SUPERIORITY||Risk Difference (RD)|4.9||||0.022921|TWO_SIDED|95.0|1.4|8.4|||Cochran-Mantel-Haenszel|||||8.4|1.4|0.022921
91590502|NCT04178967|183070695|SUPERIORITY||LS Mean Difference (Final Values)|-4.9|||<|1e-06|TWO_SIDED|95.0|-6.3|-3.5|||ANCOVA|||||-3.5|-6.3|<0.000001
91590503|NCT04178967|183070696|SUPERIORITY||Risk Difference (RD)|32.9||||1e-06|TWO_SIDED|95.0|22.2|43.6|||Cochran-Mantel-Haenszel|||||43.6|22.2|0.000001
91590504|NCT04178967|183070697|SUPERIORITY||Risk Difference (RD)|33.0||||1e-06|TWO_SIDED|95.0|22.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|22.2|0.000001
91590505|NCT04178967|183070698|SUPERIORITY||LS Mean Difference (Final Values)|-37.09|||<|1e-06|TWO_SIDED|95.0|-47.4|-26.8|||ANCOVA|||||-26.8|-47.4|<0.000001
91590506|NCT04178967|183070699|SUPERIORITY||LS Mean Difference (Final Values)|-0.7|||<|1e-06|TWO_SIDED|95.0|-0.9|-0.5|||ANCOVA|||||-0.5|-0.9|<0.000001
91590507|NCT04178967|183070700|SUPERIORITY||Risk Difference (RD)|18.9||||0.000571|TWO_SIDED|95.0|9.6|28.1|||Cochran-Mantel-Haenszel|||||28.1|9.6|0.000571
91590508|NCT04178967|183070701|SUPERIORITY||Risk Difference (RD)|0.4||||0.469221|TWO_SIDED|95.0|-0.4|1.2|||Cochran-Mantel-Haenszel|||||1.2|-0.4|0.469221
91590509|NCT04178967|183070702|SUPERIORITY||Risk Difference (RD)|2.7||||0.113194|TWO_SIDED|95.0|-0.1|5.4|||Cochran-Mantel-Haenszel|||||5.4|-0.1|0.113194
91590510|NCT04178967|183070703|SUPERIORITY||Risk Difference (RD)|13.2||||0.00023|TWO_SIDED|95.0|7.7|18.7|||Cochran-Mantel-Haenszel|||||18.7|7.7|0.000230
91590511|NCT04178967|183070704|SUPERIORITY||Risk Difference (RD)|0.4||||0.46816|TWO_SIDED|95.0|-0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|-0.4|0.468160
91590512|NCT04178967|183070705|SUPERIORITY||Risk Difference (RD)|2.9||||0.11577|TWO_SIDED|95.0|-0.1|5.8|||Cochran-Mantel-Haenszel|||||5.8|-0.1|0.115770
91590513|NCT04178967|183070706|SUPERIORITY||Risk Difference (RD)|14.2||||0.000252|TWO_SIDED|95.0|8.2|20.1|||Cochran-Mantel-Haenszel|||||20.1|8.2|0.000252
91590514|NCT04178967|183070707|SUPERIORITY||LS Mean Difference (Final Values)|-30.76|||<|1e-06|TWO_SIDED|95.0|-36.93|-24.59|||ANCOVA|||||-24.59|-36.93|<0.000001
91590515|NCT04178967|183070709|SUPERIORITY||Risk Difference (RD)|12.8||||0.238245|TWO_SIDED|95.0|-9.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|-9.5|0.238245
91590516|NCT04178967|183070709|SUPERIORITY||Risk Difference (RD)|4.8||||0.612427|TWO_SIDED|95.0|-17.8|27.3|||Cochran-Mantel-Haenszel|||||27.3|-17.8|0.612427
91590517|NCT04178967|183070710|SUPERIORITY||Risk Difference (RD)|32.6||||0.033876|TWO_SIDED|95.0|2.6|62.5|||Cochran-Mantel-Haenszel|||||62.5|2.6|0.033876
91590518|NCT04178967|183070710|SUPERIORITY||Risk Difference (RD)|13.4||||0.407417|TWO_SIDED|95.0|-17.5|44.3|||Cochran-Mantel-Haenszel|||||44.3|-17.5|0.407417
91590519|NCT04178967|183070711|SUPERIORITY||Risk Difference (RD)|20.3||||0.159281|TWO_SIDED|95.0|-11.4|52.0|||Cochran-Mantel-Haenszel|||||52.0|-11.4|0.159281
91590520|NCT04178967|183070711|SUPERIORITY||Risk Difference (RD)|20.4||||0.16495|TWO_SIDED|95.0|-10.6|51.4|||Cochran-Mantel-Haenszel|||||51.4|-10.6|0.164950
91590521|NCT04178967|183070712|SUPERIORITY||Risk Difference (RD)|19.7||||0.179704|TWO_SIDED|95.0|-12.2|51.2|||Cochran-Mantel-Haenszel|||||51.2|-12.2|0.179704
91590522|NCT04178967|183070712|SUPERIORITY||Risk Difference (RD)|24.3||||0.08308|TWO_SIDED|95.0|-6.5|55.1|||Cochran-Mantel-Haenszel|||||55.1|-6.5|0.083080
91590523|NCT04178967|183070713|SUPERIORITY||LS Mean Difference (Final Values)|-6.29||||0.176748|TWO_SIDED|95.0|-15.46|2.87|||ANCOVA|||||2.87|-15.46|0.176748
91590524|NCT04178967|183070713|SUPERIORITY||LS Mean Difference (Final Values)|-6.25||||0.183151|TWO_SIDED|95.0|-15.48|2.99|||ANCOVA|||||2.99|-15.48|0.183151
91590525|NCT04178967|183070714|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||UK||0.1|0.1|0.000001
91648161|NCT03125915|183188822|SUPERIORITY||Beta|-0.49||||0.12|TWO_SIDED|95.0|-1.11|0.12||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of SUM among those who did not complete CT video.|||0.12|-1.11|0.12
91590526|NCT04178967|183070714|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||US||0.1|0.0|0.000001
91590527|NCT04178967|183070715|SUPERIORITY||LS Mean Difference (Final Values)|4.5||||0.005304|TWO_SIDED|95.0|1.3|7.6|||ANCOVA|||||7.6|1.3|0.005304
91590528|NCT04178967|183070716|SUPERIORITY||LS Mean Difference (Final Values)|-6.0|||<|1e-06|TWO_SIDED|95.0|-7.7|-4.3|||Mixed Models Analysis|||||-4.3|-7.7|<0.000001
91590529|NCT04178967|183070717|SUPERIORITY||LS Mean Difference (Final Values)|-2.91||||0.241275|TWO_SIDED|95.0|-7.85|2.03|||ANCOVA|||||2.03|-7.85|0.241275
91590530|NCT04178967|183070718|SUPERIORITY||LS Mean Difference (Final Values)|-2.74||||0.000116|TWO_SIDED|95.0|-4.12|-1.36|||ANCOVA|||||-1.36|-4.12|0.000116
91590531|NCT04178967|183070719|SUPERIORITY||LS Mean Difference (Final Values)|-1.1||||0.645132|TWO_SIDED|95.0|-5.86|3.67|||ANCOVA|||||3.67|-5.86|0.645132
91590532|NCT04178967|183070720|SUPERIORITY||LS Mean Difference (Final Values)|-2.75||||3.1e-05|TWO_SIDED|95.0|-4.03|-1.47|||ANCOVA|||||-1.47|-4.03|0.000031
91590533|NCT04178967|183070721|SUPERIORITY||LS Mean Difference (Final Values)|0.0||||0.974417|TWO_SIDED|95.0|-0.27|0.26|||ANCOVA|||||0.26|-0.27|0.974417
91590534|NCT04178967|183070722|SUPERIORITY||LS Mean Difference (Final Values)|-4.2||||0.084769|TWO_SIDED|95.0|-9.1|0.6|||Mixed Models Analysis|||||0.6|-9.1|0.084769
91590535|NCT00628251|183070736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.6604|TWO_SIDED|95.0|0.51|1.56||If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.56|0.51|0.6604
91590536|NCT00628251|183070736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.7794||95.0|0.48|1.74||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.74|0.48|0.7794
91590537|NCT00628251|183070736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.6604|TWO_SIDED|95.0|0.45|1.62||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.62|0.45|0.6604
91590538|NCT00628251|183070737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.27||||0.1291|TWO_SIDED|95.0|0.79|7.32||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||7.32|0.79|0.1291
91590539|NCT00628251|183070737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.3131|TWO_SIDED|95.0|0.55|7.01||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||7.01|0.55|0.3131
91590540|NCT00628251|183070737|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.69||||0.1079|TWO_SIDED|95.0|0.81|9.76|||Regression, Logistic|The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||9.76|0.81|0.1079
91590541|NCT00628251|183070743|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.5781|TWO_SIDED|95.0|0.41|1.7||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||1.70|0.41|0.5781
91590542|NCT00628251|183070743|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.3417|TWO_SIDED|95.0|0.27|1.55||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||1.55|0.27|0.3417
91590543|NCT00628251|183070743|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9877|TWO_SIDED|95.0|0.44|2.27||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||2.27|0.44|0.9877
91590544|NCT01368042|183070822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_DEVIATION|32.9||0.03|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.03
91590545|NCT01368042|183070823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_DEVIATION|57.2||0.05|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.05
91590546|NCT01368042|183070824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|STANDARD_DEVIATION|56.4||0.003|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.003
91590547|NCT01368042|183070825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_DEVIATION|30.5|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
91590548|NCT01368042|183070826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_DEVIATION|27.2|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
91590549|NCT01368042|183070827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_DEVIATION|35.3|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
91590550|NCT01368042|183070828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_DEVIATION|34.8|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||<0.001
91648162|NCT03125915|183188822|SUPERIORITY||Beta|-0.34||||0.23|TWO_SIDED|95.0|-0.89|0.21||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of CT video among those who completed SUM.|||0.21|-0.89|0.23
91590551|NCT01368042|183070829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|20.9||0.38|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.38
91590552|NCT01368042|183070830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_DEVIATION|32.0|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
91590553|NCT01368042|183070831|SUPERIORITY_OR_OTHER|||||||0.03|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Physical functioning scale||||0.03
91590554|NCT01368042|183070831|SUPERIORITY_OR_OTHER|||||||0.02|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to physical health scale||||0.02
91590555|NCT01368042|183070831|SUPERIORITY_OR_OTHER|||||||0.01|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to emotional problems scale||||0.01
91590556|NCT01368042|183070831|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Energy/fatigue scale||||<0.001
91590557|NCT01368042|183070831|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Emotional well-being scale||||0.002
91590558|NCT01368042|183070831|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Social functioning scale||||0.002
91590559|NCT01368042|183070831|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Bodily pain scale||||<0.001
91648163|NCT03125915|183188822|SUPERIORITY||Beta|-0.19||||0.51|TWO_SIDED|95.0|-0.76|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||0.38|-0.76|0.51
91648164|NCT03125915|183188822|SUPERIORITY||Beta|-0.79||||0.003|TWO_SIDED|95.0|-1.32|-0.27||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed CT videos.|||-0.27|-1.32|0.003
91590560|NCT01368042|183070831|SUPERIORITY_OR_OTHER|||||||0.56|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||General health perceptions scale||||0.56
91590561|NCT01368042|183070832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|41.6||0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.001
91590562|NCT01368042|183070833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.4||0.03|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.03
91590563|NCT01368042|183070834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.9||0.06|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.06
91590564|NCT01368042|183070835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|1.7||0.84|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.84
91590565|NCT01368042|183070836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|16.5||0.67|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.67
91590566|NCT01368042|183070837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|STANDARD_DEVIATION|324.8||0.02|||||||Wilcoxon signed rank test-paired samples||n= 215 (paired samples)|||||0.02
91590567|NCT01368042|183070838|SUPERIORITY_OR_OTHER|||||||0.12|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||||||0.12
91590568|NCT02632721|183070853|OTHER||Probability of DLT rate in [0.16, 0.33)|0.081|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
91590569|NCT02632721|183070853|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
91590570|NCT02632721|183070853|OTHER||Probability of DLT rate in [0.16, 0.33)|0.028|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
91590571|NCT02632721|183070853|OTHER||Posterior probability of the DLT rate ly|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
91521401|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.671|TWO_SIDED|95.0|-53.0|34.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||34|-53|0.671
91590572|NCT02632721|183070853|OTHER||Probability of DLT rate in [0.16, 0.33)|0.012|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
91590573|NCT02632721|183070853|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
91590574|NCT04207801|183070863|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Efficacy of AUR101 was tested against placebo with respect to the primary endpoint (PASI75 response). A sample size of 25 in each of the three arms provided an 80% power with a one-sided Type I error of 0.05, if the true placebo response rate was 7% and the response rate on investigational arm(s) was 35%. The sample size was increased to 30 to account for \~ 15-20% dropouts over the study period.||||0.01
91648165|NCT03125915|183188822|SUPERIORITY||Beta|-0.25||||0.49|TWO_SIDED|95.0|-0.96|0.46||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of SUM among those who did not view the CT video.|||0.46|-0.96|0.49
91648166|NCT03125915|183188822|SUPERIORITY||Beta|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who completed SUM.|||0.11|-1.16|0.10
91648167|NCT03125915|183188822|SUPERIORITY||Beta|-0.02||||0.96|TWO_SIDED|95.0|-0.6|0.64||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who did not complete SUM.|||0.64|-0.60|0.96
91590575|NCT02663271|183070874|SUPERIORITY|We used one-sample log rank test to compare to historical control.|Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
91590576|NCT01572675|183070884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for duration of prescription at enrollment||||<0.001
91590577|NCT01572675|183070884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for duration of prescription at enrollment||||<0.001
91590578|NCT01572675|183070889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.||||<0.001
91590579|NCT01572675|183070892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.104
91590580|NCT01572675|183070892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.0049
91590581|NCT01572675|183070892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.618|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.618
91709130|NCT03035916|183311328|OTHER|||||||0.787|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.787
91590582|NCT01572675|183070893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for medical history of arterial hypertension||||0.012
91590583|NCT01572675|183070893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for medical history of arterial hypertension||||0.175
91590584|NCT01572675|183070895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for significant past treatments||||0.701
91590585|NCT01572675|183070895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for significant past treatments||||0.007
91590586|NCT01572675|183070895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.955|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for significant past treatments||||0.955
91590587|NCT01572675|183070898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Fisher Exact|||Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications||||0.049
91590588|NCT01572675|183070901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165|||||||Chi-squared|||Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment||||0.165
91590589|NCT00223678|183070903|SUPERIORITY_OR_OTHER|||||||0.849|||||||Log Rank|||||||0.849
91590590|NCT05315947|183071002|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for Cmax was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.87|||||TWO_SIDED|90.0|0.7814|0.9686||||||||0.9686|0.7814|
91590591|NCT05315947|183071003|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(0-t) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.989|||||TWO_SIDED|90.0|0.9756|1.003||||||||1.003|0.9756|
91648168|NCT02176642|183188838|NON_INFERIORITY|We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91590592|NCT02499770|183071011|OTHER||||||=|0.0097||||||The p-value was calculated using the stratified log-rank test to account for the baseline ECOG status (0-1 vs 2) as the stratification factor. Significance level was set as two-sided 0.2.|Stratified log-rank test|p-value calculated using stratified log-rank test with baseline ECOG status (0-1 vs 2) as stratification factor. Significance level was two-sided 0.2.||||||= 0.0097
91590593|NCT00315939|183071094|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
91590594|NCT04124614|183071127|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-5.59||||0.0007|TWO_SIDED|95.0|-8.79|-2.38|||MMRM|||||-2.38|-8.79|0.0007
91590595|NCT04124614|183071128|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-0.47||||0.0019|TWO_SIDED|95.0|-0.76|-0.17|||MMRM|||||-0.17|-0.76|0.0019
91590596|NCT04124614|183071129|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-12.03||||0.0016|TWO_SIDED|95.0|-19.44|-4.62|||MMRM|||||-4.62|-19.44|0.0016
91590597|NCT04415658|183071135|SUPERIORITY||Risk Ratio (RR)|1.01||||0.57|TWO_SIDED|95.0|0.97|1.07|||Chi-squared, Corrected|||80% power to detect a 10% increase in hearts transplanted||1.07|0.97|0.57
91590598|NCT04415658|183071136|NON_INFERIORITY|Six percent margin, assuming 96% graft survival in control group|Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|-2.3|6.0|||Regression, Logistic|||Non-inferiority analysis for thyroxine vs saline||6.0|-2.3|<0.001
91590599|NCT00785044|183071169|SUPERIORITY_OR_OTHER|Analysis was performed using the null hypothesis for the AUC stated as: H0: θ ≤A versus H1: θ \>A, where the AUC (θ) value was: 'A' selected based on the diagnostic utility desired from the use of myocardial 123 I-mIBG uptake measured using H/M ratio. A smooth parametric model of the ROC curve was fitted to the data. The AUC for the resulting model was calculated and 95% confidence interval for the AUC was reported. The hypothesis was tested using the Z-statistics at 'A' at level of 0.70.|Mean|0.581|||<|0.001|TWO_SIDED|95.0|0.532|0.63||At 0.05 level of significance.|Z-statistic|||"Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio."||0.630|0.532|<0.001
91590600|NCT01830855|183071171|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.93|1.14||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.14|0.93|
91590601|NCT01830855|183071171|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.13|0.92|
91590602|NCT01830855|183071171|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.12|0.88|
91590603|NCT01830855|183071171|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.85|
91590604|NCT01830855|183071171|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.86|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.86|
91590605|NCT01830855|183071171|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.88|1.14||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948||1.14|0.88|
91590606|NCT01798992|183071247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.685
91648169|NCT02176642|183188839|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91590607|NCT01798992|183071248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.071
91590608|NCT00763971|183071255|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-18.6|||<|0.001|TWO_SIDED|95.0|-21.5|-15.7|||ANCOVA|||||-15.7|-21.5|<0.001
91648170|NCT02176642|183188840|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91590609|NCT00763971|183071255|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-13.0|||<|0.001|TWO_SIDED|95.0|-15.9|-10.2|||ANCOVA|||||-10.2|-15.9|<0.001
91590610|NCT00763971|183071256|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|63.6|||<|0.001|TWO_SIDED|95.0|53.0|74.1|||Cochran-Mantel-Haenszel|||||74.1|53.0|<0.001
91590611|NCT00763971|183071256|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|34.6|57.7|||Cochran-Mantel-Haenszel|||||57.7|34.6|<0.001
91590612|NCT00763971|183071257|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-21.3|||<|0.001|TWO_SIDED|95.0|-25.5|-17.0|||ANCOVA|||||-17.0|-25.5|<0.001
91590613|NCT00763971|183071257|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-15.1|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||ANCOVA|||||-10.9|-19.3|<0.001
91590614|NCT00763971|183071259|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|8.8|||<|0.001|TWO_SIDED|95.0|6.1|11.5|||ANCOVA|||||11.5|6.1|<0.001
91590615|NCT00763971|183071259|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|7.3|||<|0.001|TWO_SIDED|95.0|4.6|10.0|||ANCOVA|||||10.0|4.6|<0.001
91590616|NCT00763971|183071260|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.2|-0.4|<0.001
91590617|NCT00763971|183071260|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||||-0.1|-0.3|<0.001
91648171|NCT02176642|183188841|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91648172|NCT02176642|183188842|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91648173|NCT02176642|183188843|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91648174|NCT02176642|183188844|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91590618|NCT01540825|183071273|SUPERIORITY_OR_OTHER||Slope|1.2472|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|1.1831|1.3112|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.||1.3112|1.1831|
91590619|NCT01540825|183071275|SUPERIORITY_OR_OTHER||Slope|1.1626|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.1195|1.2057|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.||1.2057|1.1195|
91590620|NCT01540825|183071276|SUPERIORITY_OR_OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.108|1.1941|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed||1.1941|1.1080|
91590621|NCT01641237|183071282|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||<0.0001
91590622|NCT01641237|183071282|SUPERIORITY_OR_OTHER|||||||0.3748||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||0.3748
91590623|NCT01641237|183071283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.1898|TWO_SIDED|95.0|-1.09|5.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||5.43|-1.09|0.1898
91590624|NCT01641237|183071283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.6||||0.0009|TWO_SIDED|95.0|2.35|8.86||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.||8.86|2.35|0.0009
91590625|NCT01641237|183071283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.43||||0.0389|TWO_SIDED|95.0|0.18|6.68||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||6.68|0.18|0.0389
91590626|NCT01641237|183071283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.86|||<|0.0001|TWO_SIDED|95.0|6.58|13.13||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||13.13|6.58|<0.0001
91590627|NCT01641237|183071283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.68|||<|0.0001|TWO_SIDED|95.0|4.41|10.96||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||10.96|4.41|<0.0001
91648175|NCT02176642|183188845|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91648176|NCT02176642|183188846|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
91590628|NCT01641237|183071283|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.25||||0.0112|TWO_SIDED|95.0|0.98|7.53||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||7.53|0.98|0.0112
91590629|NCT01641237|183071284|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.||||<0.0001
91590630|NCT01641237|183071284|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANOVA|||Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.||||0.0002
91590631|NCT01641237|183071284|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|32.38|||<|0.0001|TWO_SIDED|95.0|25.18|39.59||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||39.59|25.18|<0.0001
91648177|NCT00295620|183188851|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.425|TWO_SIDED|95.0|0.79|1.11|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event||1.11|0.79|0.425
91648178|NCT00295620|183188852|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.867|TWO_SIDED|95.0|0.83|1.25|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event||1.25|0.83|0.867
91648179|NCT00295620|183188853|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.052|TWO_SIDED|95.0|1.0|1.84|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture||1.84|1.00|0.052
91590632|NCT01641237|183071284|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|31.46|||<|0.0001|TWO_SIDED|95.0|24.25|38.67||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||38.67|24.25|<0.0001
91590633|NCT01641237|183071284|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.81|||<|0.0001|TWO_SIDED|95.0|13.6|28.02||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||28.02|13.60|<0.0001
91590634|NCT01641237|183071284|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.92||||0.8|TWO_SIDED|95.0|-6.25|8.1||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||8.10|-6.25|0.8000
91590635|NCT01641237|183071284|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.57||||0.0017|TWO_SIDED|95.0|4.4|18.74||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||18.74|4.40|0.0017
91590636|NCT01641237|183071284|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.65||||0.0038|TWO_SIDED|95.0|3.48|17.81||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||17.81|3.48|0.0038
91590637|NCT01641237|183071285|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.||||<0.0001
91590638|NCT01641237|183071285|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.||||0.0008
91648180|NCT00295620|183188854|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.678|TWO_SIDED|95.0|0.81|1.38|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma||1.38|0.81|0.678
91648181|NCT00295620|183188855|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.531|TWO_SIDED|95.0|0.75|1.77|||Log Rank|||Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma||1.77|0.75|0.531
91648182|NCT01625286|183188874|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.8||||0.308|TWO_SIDED|80.0|0.6|1.06||2-sided p-value|Regression, Cox|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.06|0.60|0.308
91590639|NCT01641237|183071285|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.90|1.42|<0.0001
91782067|NCT00337675|183443847|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|5.3|STANDARD_ERROR_OF_MEAN|7.3||0.51||95.0|-11.4|19.6||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||19.6|-11.4|0.510
91590640|NCT01641237|183071285|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.6|||<|0.0001|TWO_SIDED|95.0|1.36|1.85||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.85|1.36|<0.0001
91648183|NCT01625286|183188875|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.081|TWO_SIDED|80.0|-17.1|-0.8||1-sided p-value|ANCOVA|||||-0.8|-17.1|0.081
91648184|NCT01625286|183188881|SUPERIORITY||Odds Ratio (OR)|1.53||||0.139|TWO_SIDED|80.0|0.93|2.54||1-sided p-value|Regression, Logistic|including treatment and PIK3CA status as factors/covariates||||2.54|0.93|0.139
91648185|NCT01625286|183188882|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.77||||0.482|TWO_SIDED|80.0|0.48|1.24||2-sided p-value|Log Rank|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.24|0.48|0.482
91648186|NCT04523831|183188885|SUPERIORITY||Cox Proportional Hazard|0.53|||<|0.03|TWO_SIDED|95.0|0.3|0.96|||Regression, Linear|||||0.96|0.30|<0.03
91590641|NCT01641237|183071285|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.38|0.86||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.86|0.38|<0.0001
91590642|NCT01641237|183071285|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.29||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.29|-0.19|0.6680
91590643|NCT01641237|183071285|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.8|1.28||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.28|0.80|<0.0001
91590644|NCT01641237|183071285|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.99|||<|0.0001|TWO_SIDED|95.0|0.75|1.23||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.23|0.75|<0.0001
91590645|NCT01301456|183071311|SUPERIORITY_OR_OTHER||Least square (LS) mean|-21.16|STANDARD_ERROR_OF_MEAN|16.766||0.219|TWO_SIDED|80.0|-43.26|0.93|||Mixed meal tolerance test|||Day 30||0.93|-43.26|0.219
91590646|NCT01301456|183071311|SUPERIORITY_OR_OTHER||LS mean|-34.18|STANDARD_ERROR_OF_MEAN|15.189||0.034|TWO_SIDED|80.0|-54.2|-14.16|||Mixed meal tolerance test|||Day 30||-14.16|-54.20|0.034
91590647|NCT01301456|183071311|SUPERIORITY_OR_OTHER||LS mean|-33.67|STANDARD_ERROR_OF_MEAN|15.806||0.044|TWO_SIDED|80.0|-54.5|-12.84|||Mixed meal tolerance test|||Day 30||-12.84|-54.50|0.044
91590648|NCT01301456|183071311|SUPERIORITY_OR_OTHER||LS mean|-2.93|STANDARD_ERROR_OF_MEAN|16.111||0.857|TWO_SIDED|80.0|-24.16|18.31|||Mixed meal tolerance test|||Day 30||18.31|-24.16|0.857
91648187|NCT04523831|183188886|SUPERIORITY||Cox Proportional Hazard|0.51|||<|0.004|TWO_SIDED|95.0|0.32|0.8|||Regression, Logistic|||||0.80|0.32|<0.004
91648188|NCT04523831|183188887|SUPERIORITY||Cox Proportional Hazard|0.45|||<|0.013|TWO_SIDED|95.0|0.23|0.85|||Regression, Logistic|||||0.85|0.23|<0.013
91648189|NCT04523831|183188888|SUPERIORITY||Cox Proportional Hazard|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.81|||Regression, Logistic|||||0.81|0.44|<0.001
91648190|NCT01963676|183188902|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from Day 5 to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups:~H0: μ1 = μ2 μ1: mean(difference 5 days-baseline) for tDCS group (n=13) μ2: mean(difference 5 days-baseline) for sham group (n=13)"||||0.48
91590649|NCT01301456|183071312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.251||0.419|TWO_SIDED|80.0|-0.54|0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.12|-0.54|0.419
91590650|NCT01301456|183071312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.224||0.077|TWO_SIDED|80.0|-0.71|-0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.12|-0.71|0.077
91590651|NCT01301456|183071312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.147|TWO_SIDED|80.0|-0.65|-0.04|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.04|-0.65|0.147
91590652|NCT01301456|183071312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.244||0.086|TWO_SIDED|80.0|-0.76|-0.11|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.11|-0.76|0.086
91590653|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|4.11|STANDARD_ERROR_OF_MEAN|9.326||0.663|TWO_SIDED|80.0|-8.16|16.37|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||16.37|-8.16|0.663
91590654|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|8.472||0.825|TWO_SIDED|80.0|-13.03|9.25|||mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.25|-13.03|0.825
91590655|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|8.791||0.878|TWO_SIDED|80.0|-10.2|12.92|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.92|-10.20|0.878
91648191|NCT01963676|183188903|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from 1 Month to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the AHRS score changes from baseline to 1month between the groups:~H0: μ1 = μ2 μ1: mean(difference 1 month-baseline) for tDCS group (n=13) μ2: mean(difference 1 month-baseline) for sham group (n=13)"||||0.86
91648192|NCT00409188|183188939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.893||||0.1566|TWO_SIDED|95.0|0.763|1.044|||Regression, Cox|||||1.044|0.763|0.1566
91648193|NCT00409188|183188940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.0226|TWO_SIDED|95.0|0.732|0.977|||Regression, Cox|||||0.977|0.732|0.0226
91590656|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|8.829||0.936|TWO_SIDED|80.0|-10.89|12.33|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.33|-10.89|0.936
91590657|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|13.037||0.959|TWO_SIDED|80.0|-16.46|17.82|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||17.82|-16.46|0.959
91590658|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.46|STANDARD_ERROR_OF_MEAN|11.872||0.011|TWO_SIDED|80.0|-48.07|-16.85|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-16.85|-48.07|0.011
91590659|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|12.212||0.833|TWO_SIDED|80.0|-18.67|13.45|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.45|-18.67|0.833
91590660|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|12.365||0.565|TWO_SIDED|80.0|-23.47|9.05|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.05|-23.47|0.565
91590661|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|9.713||0.703|TWO_SIDED|80.0|-16.52|9.02|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.02|-16.52|0.703
91590662|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.46|STANDARD_ERROR_OF_MEAN|8.827||0.008|TWO_SIDED|80.0|-37.07|-13.85|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.85|-37.07|0.008
91590663|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|9.061||0.253|TWO_SIDED|80.0|-22.51|1.32|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.32|-22.51|0.253
91590664|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|9.198||0.128|TWO_SIDED|80.0|-26.57|-2.38|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-2.38|-26.57|0.128
91590665|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.15|STANDARD_ERROR_OF_MEAN|11.421||0.196|TWO_SIDED|80.0|-30.17|-0.13|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.13|-30.17|0.196
91648194|NCT00409188|183188941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.0528|TWO_SIDED|95.0|0.752|1.002|||Regression, Cox|||||1.002|0.752|0.0528
91590666|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.17|STANDARD_ERROR_OF_MEAN|10.393||0.012|TWO_SIDED|80.0|-41.84|-14.51|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-14.51|-41.84|0.012
91590667|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.48|STANDARD_ERROR_OF_MEAN|10.773||0.047|TWO_SIDED|80.0|-36.65|-8.32|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-8.32|-36.65|0.047
91590668|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.63|STANDARD_ERROR_OF_MEAN|11.837||0.023|TWO_SIDED|80.0|-44.19|-13.06|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.06|-44.19|0.023
91590669|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|13.576||0.711|TWO_SIDED|80.0|-12.77|22.93|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||22.93|-12.77|0.711
91590670|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|12.365||0.666|TWO_SIDED|80.0|-10.86|21.66|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||21.66|-10.86|0.666
91590671|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05|STANDARD_ERROR_OF_MEAN|12.333||0.807|TWO_SIDED|80.0|-19.27|13.17|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.17|-19.27|0.807
91590672|NCT01301456|183071314|SUPERIORITY_OR_OTHER||LS Mean Difference|6.79|STANDARD_ERROR_OF_MEAN|12.877||0.603|TWO_SIDED|80.0|-10.15|23.72|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||23.72|-10.15|0.603
91590673|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.551||0.387|TWO_SIDED|80.0|-0.24|1.21|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.21|-0.24|0.387
91590674|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.501||0.309|TWO_SIDED|80.0|-0.14|1.18|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.18|-0.14|0.309
91648195|NCT01681771|183188994|SUPERIORITY|||||||0.21|||||||ANCOVA|ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline||||||0.21
91709131|NCT03035916|183311328|OTHER|||||||0.306|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.306
91590675|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.518||0.956|TWO_SIDED|80.0|-0.71|0.65|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.65|-0.71|0.956
91590676|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.542||0.089|TWO_SIDED|80.0|0.24|1.67|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.67|0.24|0.089
91590677|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.923||0.434|TWO_SIDED|80.0|-0.48|1.95|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.95|-0.48|0.434
91590678|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.841||0.15|TWO_SIDED|80.0|0.14|2.35|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.35|0.14|0.150
91590679|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.861||0.752|TWO_SIDED|80.0|-0.86|1.41|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.41|-0.86|0.752
91590680|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.888||0.492|TWO_SIDED|80.0|-0.55|1.79|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.79|-0.55|0.492
91590681|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.064||0.358|TWO_SIDED|80.0|-0.4|2.4|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.40|-0.40|0.358
91590682|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.11|TWO_SIDED|80.0|0.33|2.88|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.33|0.110
91590683|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.993||0.461|TWO_SIDED|80.0|-0.56|2.05|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.05|-0.56|0.461
91590684|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.021||0.286|TWO_SIDED|80.0|-0.23|2.45|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.45|-0.23|0.286
91709132|NCT03035916|183311328|OTHER|||||||0.921|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.921
91590685|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|1.172||0.362|TWO_SIDED|80.0|-0.45|2.63|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.63|-0.45|0.362
91590686|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.069||0.179|TWO_SIDED|80.0|0.07|2.88|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.07|0.179
91590687|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.092||0.342|TWO_SIDED|80.0|-0.38|2.49|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.49|-0.38|0.342
91590688|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|STANDARD_ERROR_OF_MEAN|1.129||0.272|TWO_SIDED|80.0|-0.22|2.75|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.75|-0.22|0.272
91590689|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|1.317||0.979|TWO_SIDED|80.0|-1.77|1.7|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.70|-1.77|0.979
91590690|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.201||0.568|TWO_SIDED|80.0|-2.27|0.88|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.88|-2.27|0.568
91590691|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.201||0.311|TWO_SIDED|80.0|-0.34|2.82|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.82|-0.34|0.311
91590692|NCT01301456|183071316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.26||0.71|TWO_SIDED|80.0|-1.18|2.13|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.13|-1.18|0.710
91590693|NCT05395104|183071330|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.0865|||||TWO_SIDED|90.0|0.9724|1.2141||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2141|0.9724|
91590694|NCT05395104|183071332|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1174|||||TWO_SIDED|90.0|0.9784|1.2762||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2762|0.9784|
91590695|NCT05395104|183071333|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1239|||||TWO_SIDED|90.0|0.9887|1.2776||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2776|0.9887|
91521402|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-23.0|64.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||64|-23|0.355
91521403|NCT01218126|182917372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.781|TWO_SIDED|95.0|-38.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||50|-38|0.781
91709133|NCT03035916|183311328|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
91782068|NCT00337675|183443847|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|-1.2|STANDARD_ERROR_OF_MEAN|7.8||0.884||95.0|-19.2|14.0||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||14.0|-19.2|0.884
91782069|NCT00337675|183443848|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.176||95.0|-0.46|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.46|0.176
91782070|NCT00337675|183443848|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.202||95.0|-0.44|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.44|0.202
91782071|NCT00337675|183443849|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.045||95.0|-0.24|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.24|0.045
91782072|NCT00337675|183443849|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.061||95.0|-0.23|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.23|0.061
91782073|NCT02015637|183443850|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rate|-5.9|||||TWO_SIDED|95.0|-13.18|1.36||||||||1.36|-13.18|
91782074|NCT02015637|183443851|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rates|-9.9|||||TWO_SIDED|95.0|-16.03|-3.87||||||||-3.87|-16.03|
91782075|NCT01317277|183443857|SUPERIORITY|||||||0.68||||||In between-group analyses, overall MEMS adherence was defined as % of doses taken.|Wilcoxon (Mann-Whitney)|Non-parametric methods.||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.68
91709134|NCT03035916|183311328|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
91590696|NCT00789750|183071356|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.16|-0.49|<0.001
91590697|NCT00789750|183071357|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.24|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.24|<0.001
91590698|NCT00789750|183071358|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.056||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.32|0.0002
91590699|NCT00789750|183071359|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.077|<|0.001|TWO_SIDED|95.0|-0.51|-0.2|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.20|-0.51|<0.001
91590700|NCT00789750|183071360|OTHER|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
91590701|NCT00789750|183071361|OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-21.93|-7.49|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-7.49|-21.93|<0.0001
91648196|NCT00265083|183188995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide \>=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP\<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP\<1.5mg/dL and 32.5-45% in pts with screening CRP\>=1.5mg/dL, between Groups I vs II or III.||||<0.001
91648197|NCT00265083|183188995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
91648198|NCT00265083|183188995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
91648199|NCT00265083|183188996|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.||||<0.001
91648200|NCT00265083|183188996|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group II and Group I.||||<0.001
91648201|NCT00265083|183188996|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group III and Group I.||||<0.001
91648202|NCT00265083|183188997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.||||<0.001
91590702|NCT00789750|183071362|OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
91590703|NCT00789750|183071363|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91590704|NCT00789750|183071364|OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
91590705|NCT00789750|183071365|OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91590706|NCT00789750|183071366|OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-20.62|-12.18|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-12.18|-20.62|<0.001
91590707|NCT00789750|183071367|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.31||0.1652|TWO_SIDED|95.0|-0.75|4.39|||ANCOVA|||Treatment difference = Colesevelam - Placebo||4.39|-0.75|0.1652
91590708|NCT00789750|183071368|OTHER||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.44|-6.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-6.16|-13.44|<0.0001
91590709|NCT00789750|183071369|OTHER||Median Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|67.01||0.0004|TWO_SIDED|95.0|5.3|17.5|||ANCOVA||The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.|Treatment difference = Colesevelam - Placebo||17.5|5.3|0.0004
91590710|NCT00789750|183071370|OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.93||0.0003|TWO_SIDED|95.0|1.58|5.23|||ANCOVA|||Treatment difference = Colesevelam - Placebo||5.23|1.58|0.0003
91590711|NCT00789750|183071371|OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.0001|TWO_SIDED|95.0|-11.75|-5.78|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-5.78|-11.75|<0.0001
91590712|NCT00789750|183071372|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.77||0.7286|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA|||Treatment difference = Colesevelam - Placebo||2.9|-4.1|0.7286
91590713|NCT00789750|183071373|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0653|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Treatment difference = Colesevelam - Placebo||0.0|-0.4|0.0653
91648203|NCT00265083|183188997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group II and Group I.||||<0.001
91590714|NCT00789750|183071374|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8862|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||Treatment difference = Colesevelam - Placebo||1.3|-1.5|0.8862
91590715|NCT04422990|183071414|NON_INFERIORITY|Noninferiority in mean CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least squares mean difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures model||Least squares mean difference (LID018869 minus Biofinity).|||0.01|-0.01|
91590716|NCT04422990|183071415|NON_INFERIORITY|Proportion of subjects was used for the statistical analysis. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Generalized linear mixed model||Lens difference (LID018869 minus Biofinity)|||0.02|-0.04|
91590717|NCT03740997|183071432|OTHER||Mean Difference (Net)|16.2|STANDARD_DEVIATION|5.46||0.0008|TWO_SIDED|95.0|10.44|21.89|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||21.89|10.44|0.0008
91590718|NCT03740997|183071432|OTHER||Mean Difference (Net)|17.1|STANDARD_DEVIATION|13.49|<|0.0001|TWO_SIDED|95.0|11.11|23.07|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||23.07|11.11|<0.0001
91590719|NCT03740997|183071432|OTHER||Mean Difference (Net)|19.3|STANDARD_DEVIATION|6.5||0.0002|TWO_SIDED|95.0|13.28|25.3|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||25.30|13.28|0.0002
91648204|NCT00265083|183188997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group III and Group I.||||<0.001
91590720|NCT03740997|183071432|OTHER||Mean Difference (Net)|18.5|STANDARD_DEVIATION|11.68|<|0.0001|TWO_SIDED|95.0|13.47|23.57|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||23.57|13.47|<0.0001
91648205|NCT00265083|183188998|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.||||0.288
91648206|NCT00265083|183188998|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group II and Group I.||||0.444
91590721|NCT03740997|183071432|OTHER||Mean Difference (Net)|19.8|STANDARD_DEVIATION|3.06|<|0.0001|TWO_SIDED|95.0|16.62|23.05|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||23.05|16.62|<0.0001
91782076|NCT01317277|183443858|SUPERIORITY|||||||0.95||||||MEMS adherence based on dose timing was examined for between-group differences.|Wilcoxon (Mann-Whitney)|Non-parametric methods||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.95
91782077|NCT01317277|183443859|SUPERIORITY|||||||0.05||||||Z = -1.97|Wilcoxon (Mann-Whitney)|Non-parametric methods; P-Value is calculated.||Text-reported METH use days||||0.05
91590722|NCT03740997|183071432|OTHER||Mean Difference (Net)|20.1|STANDARD_DEVIATION|13.38|<|0.0001|TWO_SIDED|95.0|14.16|26.03|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||26.03|14.16|<0.0001
91590723|NCT03740997|183071432|OTHER||Mean Difference (Net)|22.0|STANDARD_DEVIATION|2.77|<|0.0001|TWO_SIDED|95.0|19.44|24.56|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||24.56|19.44|<0.0001
91782078|NCT02688777|183443860|SUPERIORITY||Hazard Ratio, log|0.6|||||TWO_SIDED|||||||||||||
91590724|NCT03740997|183071432|OTHER||Mean Difference (Net)|21.2|STANDARD_DEVIATION|13.34|<|0.0001|TWO_SIDED|95.0|15.45|26.99|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||26.99|15.45|<0.0001
91590725|NCT03740997|183071432|OTHER||Mean Difference (Net)|11.8|STANDARD_DEVIATION|9.35||0.0268|TWO_SIDED|95.0|2.02|21.64|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||21.64|2.02|0.0268
91590726|NCT03740997|183071432|OTHER||Mean Difference (Net)|16.1|STANDARD_DEVIATION|15.08|<|0.0001|TWO_SIDED|95.0|9.45|22.82|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||22.82|9.45|<0.0001
91590727|NCT03740997|183071432|OTHER||Mean Difference (Net)|12.1|STANDARD_DEVIATION|6.59||0.0028|TWO_SIDED|95.0|6.04|18.24|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||18.24|6.04|0.0028
91648207|NCT00265083|183188998|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group III and Group I.||||0.247
91782079|NCT02688777|183443861|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.37|TWO_SIDED|||||A priori threshold for significance is p \< 0.05.|t-test, 2 sided|||||||0.37
91782080|NCT02688777|183443862|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02||0.13|TWO_SIDED|||||A priori threshold set for p \< 0.05|t-test, 2 sided|||||||0.13
91782081|NCT02688777|183443863|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.4|TWO_SIDED|||||A priori threshold p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.40
91782082|NCT02688777|183443864|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|3.4||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
91782083|NCT02688777|183443865|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.1||0.43|TWO_SIDED|||||A priori threshold set at p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.43
91782084|NCT02688777|183443866|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED|||||A prior threshold for significance set at p \< 0.05|t-test, 2 sided|||||||0.02
91590728|NCT03740997|183071432|OTHER||Mean Difference (Net)|15.8|STANDARD_DEVIATION|13.37|<|0.0001|TWO_SIDED|95.0|10.04|21.61|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||21.61|10.04|<0.0001
91590729|NCT01849497|183071446|SUPERIORITY_OR_OTHER||Treatment Difference|-6.8|||||TWO_SIDED|95.0|-16.3|2.0||||||||2.0|-16.3|
91590730|NCT01849497|183071447|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-3.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-10.38|2.99||||||||2.99|-10.38|
91590731|NCT03346057|183071463|OTHER||Estimated Difference in percentage|-6.7||||0.026|TWO_SIDED|95.0|-17.5|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-17.5|0.026
91590732|NCT03346057|183071463|OTHER||Estimated Difference in percentage|-6.2||||0.058|TWO_SIDED|95.0|-17.3|0.2|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||0.2|-17.3|0.058
91590733|NCT03346057|183071463|OTHER||Estimated Difference in percentage|-2.0||||0.73|TWO_SIDED|95.0|-17.8|8.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||8.6|-17.8|0.730
91590734|NCT03346057|183071464|OTHER||Estimated Difference in percentage|-14.9||||0.007|TWO_SIDED|95.0|-28.8|-4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-4.0|-28.8|0.007
91590735|NCT03346057|183071464|OTHER||Estimated Difference in percentage|-12.2||||0.036|TWO_SIDED|95.0|-26.1|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-26.1|0.036
91590736|NCT03346057|183071464|OTHER||Estimated Difference in percentage|-9.9||||0.158|TWO_SIDED|95.0|-27.6|3.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||3.6|-27.6|0.158
91648208|NCT03154333|183189009|OTHER||Risk Ratio (RR)|1.01||||0.9666|TWO_SIDED|95.0|0.63|1.62|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||1.62|0.63|0.9666
91782085|NCT02688777|183443867|SUPERIORITY||Mean Difference (Final Values)|13.95|STANDARD_ERROR_OF_MEAN|8.9||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
91590737|NCT03346057|183071465|OTHER||Estimated Difference in percentage|-0.9||||0.637|TWO_SIDED|95.0|-9.4|4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||4.0|-9.4|0.637
91590738|NCT03346057|183071465|OTHER||Estimated Difference in percentage|-2.1||||0.134|TWO_SIDED|95.0|-10.6|1.5|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||1.5|-10.6|0.134
91590739|NCT03346057|183071465|OTHER||Estimated Difference in percentage|-1.7||||0.577|TWO_SIDED|95.0|-14.7|5.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||5.8|-14.7|0.577
91590740|NCT03346057|183071466|OTHER||Estimated Difference in percentage|6.2|||||TWO_SIDED|95.0|-2.6|18.5||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||18.5|-2.6|
91590741|NCT03346057|183071466|OTHER||Estimated Difference in percentage|0.5|||||TWO_SIDED|95.0|-9.3|13.1||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||13.1|-9.3|
91590742|NCT03346057|183071466|OTHER||Estimated Difference in percentage|2.0|||||TWO_SIDED|95.0|-8.4|17.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||17.7|-8.4|
91590743|NCT03346057|183071467|OTHER||Estimated Difference in percentage|5.6|||||TWO_SIDED|95.0|-5.5|14.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||14.3|-5.5|
91590744|NCT03346057|183071467|OTHER||Estimated Difference in percentage|1.5|||||TWO_SIDED|95.0|-9.2|9.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||9.3|-9.2|
91590745|NCT03346057|183071467|OTHER||Estimated Difference in percentage|0.9|||||TWO_SIDED|95.0|-15.1|12.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||12.7|-15.1|
91590746|NCT03346057|183071468|OTHER||Estimated Difference in percentage|-2.1|||||TWO_SIDED|95.0|-11.8|3.8||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 2 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||3.8|-11.8|
91648209|NCT03154333|183189010|OTHER||Risk Ratio (RR)|1.53||||0.2861|TWO_SIDED|95.0|0.41|3.28|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||3.28|0.41|0.2861
91648210|NCT01872689|183189058|SUPERIORITY||Median Difference (Final Values)|0.98111|STANDARD_ERROR_OF_MEAN|1.31064||0.4555|TWO_SIDED|95.0|-1.61|3.57|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||3.57|-1.61|0.4555
91782086|NCT02688777|183443868|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
91782087|NCT02688777|183443869|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
91782088|NCT02688777|183443870|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91782089|NCT02688777|183443871|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91782090|NCT02688777|183443872|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
91590747|NCT03346057|183071468|OTHER||Estimated Difference in percentage|1.8|||||TWO_SIDED|95.0|-8.1|8.4||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 4 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||8.4|-8.1|
91590748|NCT03346057|183071468|OTHER||Estimated Difference in percentage|1.1|||||TWO_SIDED|95.0|-13.5|11.1||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 16 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||11.1|-13.5|
91590749|NCT00705432|183071501|SUPERIORITY_OR_OTHER||The difference in SVR|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||34.1|19.1|<0.0001
91590750|NCT00705432|183071501|SUPERIORITY_OR_OTHER||The difference in SVR|28.3|||<|0.0001|TWO_SIDED|95.0|20.8|35.8|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.8|20.8|<0.0001
91590751|NCT00705432|183071501|SUPERIORITY_OR_OTHER||The difference in SVR|19.2||||0.044|TWO_SIDED|95.0|1.6|36.9|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.9|1.6|0.0440
91590752|NCT00705432|183071501|SUPERIORITY_OR_OTHER||The difference in SVR|29.7||||0.0035|TWO_SIDED|95.0|12.2|47.1|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||47.1|12.2|0.0035
91590753|NCT00705432|183071502|SUPERIORITY_OR_OTHER||The difference in SVR rates|27.5|||<|0.0001|TWO_SIDED|95.0|19.2|35.2|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.2|19.2|<0.0001
91590754|NCT00705432|183071502|SUPERIORITY_OR_OTHER||The difference in SVR rates|29.1|||<|0.0001|TWO_SIDED|95.0|21.5|36.8|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.8|21.5|<0.0001
91590755|NCT00705432|183071502|SUPERIORITY_OR_OTHER||The difference in SVR|21.3||||0.0366|TWO_SIDED|95.0|2.3|40.2|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||40.2|2.3|0.0366
91648211|NCT01872689|183189058|SUPERIORITY||Mean Difference (Final Values)|0.49998|STANDARD_ERROR_OF_MEAN|0.84946||0.5566|TWO_SIDED|95.0|-1.17|2.17|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.17|-1.17|0.5566
91648212|NCT01872689|183189059|SUPERIORITY||Median Difference (Final Values)|21.93023|STANDARD_ERROR_OF_MEAN|21.62248||0.3129|TWO_SIDED|95.0|-20.97|64.83|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||64.83|-20.97|0.3129
91521404|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.742|TWO_SIDED|95.0|-66.0|93.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||93|-66|0.742
91590756|NCT00705432|183071502|SUPERIORITY_OR_OTHER||The difference in SVR|27.2||||0.0107|TWO_SIDED|95.0|9.0|45.3|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||45.3|9.0|0.0107
91590757|NCT01557348|183071511|SUPERIORITY_OR_OTHER|||||||0.0068||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0068
91590758|NCT01557348|183071512|SUPERIORITY_OR_OTHER|||||||0.0588||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0588
91590759|NCT01557348|183071513|SUPERIORITY_OR_OTHER|||||||0.1126||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 6||||0.1126
91590760|NCT01557348|183071513|SUPERIORITY_OR_OTHER|||||||0.2342||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 12||||0.2342
91590761|NCT01557348|183071514|SUPERIORITY_OR_OTHER|||||||0.4168||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 6||||0.4168
91648213|NCT01872689|183189059|SUPERIORITY||Mean Difference (Final Values)|-21.4127|STANDARD_ERROR_OF_MEAN|16.8016||0.2036|TWO_SIDED|95.0|-54.5|11.67|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||11.67|-54.50|0.2036
91782091|NCT02549365|183443873|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.6|13.9|||||Incidence of laboratory confirmed influenza is compared between those vaccinated and household controls. VE will be calculated as 1 - RR with 95% confidence intervals using Poisson regression.|||13.9|0.6|
91590762|NCT01557348|183071514|SUPERIORITY_OR_OTHER|||||||0.5867||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 12||||0.5867
91648214|NCT01872689|183189061|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.4299|TWO_SIDED|95.0|0.44|1.41|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.41|0.44|0.4299
91590763|NCT01557348|183071515|SUPERIORITY_OR_OTHER|||||||0.8758||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 6||||0.8758
91590764|NCT01557348|183071515|SUPERIORITY_OR_OTHER|||||||0.4849||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 12||||0.4849
91590765|NCT01557348|183071516|SUPERIORITY_OR_OTHER|||||||0.0086||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 6||||0.0086
91590766|NCT01557348|183071516|SUPERIORITY_OR_OTHER|||||||0.2918||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 12||||0.2918
91590767|NCT01557348|183071517|SUPERIORITY_OR_OTHER|||||||0.0764||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 6||||0.0764
91590768|NCT01557348|183071517|SUPERIORITY_OR_OTHER|||||||0.0587||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 12||||0.0587
91590769|NCT01557348|183071518|SUPERIORITY_OR_OTHER|||||||0.0443||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 6||||0.0443
91590770|NCT01557348|183071518|SUPERIORITY_OR_OTHER|||||||0.4802||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 12||||0.4802
91590771|NCT01557348|183071519|SUPERIORITY_OR_OTHER|||||||0.2026||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 6||||0.2026
91590772|NCT01557348|183071519|SUPERIORITY_OR_OTHER|||||||0.0295||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 12||||0.0295
91782092|NCT00912795|183443876|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|0.62|
91590773|NCT01557348|183071520|SUPERIORITY_OR_OTHER|||||||0.337||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 6||||0.3370
91590774|NCT01557348|183071520|SUPERIORITY_OR_OTHER|||||||0.1515||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 12||||0.1515
91590775|NCT01557348|183071521|SUPERIORITY_OR_OTHER|||||||0.3253||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 6||||0.3253
91590776|NCT01557348|183071521|SUPERIORITY_OR_OTHER|||||||0.3535||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 12||||0.3535
91590777|NCT01667107|183071533|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.53||||0.139|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.139
91590778|NCT01667107|183071533|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.59||||0.057|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.057
91590779|NCT03427125|183071535|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91782093|NCT00912795|183443877|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.5|3.2||||||||3.2|0.50|
91782094|NCT00912795|183443878|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5|||||TWO_SIDED|95.0|0.81|7.5||||||||7.5|0.81|
91782095|NCT00912795|183443879|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|.62|
91782096|NCT00473382|183443886|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.8|||<|0.0001|TWO_SIDED|95.0|11.4|30.2||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||30.2|11.4|<0.0001
91782097|NCT00473382|183443886|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|33.3|||<|0.0001|TWO_SIDED|95.0|23.8|42.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||42.8|23.8|<0.0001
91648215|NCT01872689|183189061|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3751|TWO_SIDED|95.0|0.56|1.24|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.24|0.56|0.3751
91590780|NCT03427125|183071536|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.0020
91590781|NCT02281357|183071538|SUPERIORITY|The null hypothesis was that the average percentage change in OCS dose on tralokinumab was equal to the average percentage change in OCS dose on placebo.|LS Mean difference|-7.78||||0.271|TWO_SIDED|95.0|-21.7|6.15|||ANCOVA|The analysis of covariance (ANCOVA) model utilised a sandwich estimator for the variance.|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate. No interaction terms were included in the model. All group comparisons from the ANCOVA model were based on Type III sums of squares.|Comparison of percent change from baseline in OCS dose: tralokinumab vs placebo.||6.15|-21.70|0.271
91590782|NCT02281357|183071539|SUPERIORITY||Odds Ratio (OR)|1.33||||0.442|TWO_SIDED|95.0|0.65|2.73|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of OCS dose ≤5.0 mg: tralokinumab vs placebo.||2.73|0.65|0.442
91590783|NCT02281357|183071540|SUPERIORITY||Odds Ratio (OR)|1.38||||0.356|TWO_SIDED|95.0|0.7|2.74|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of ≥50% reduction in OCS dose: tralokinumab vs placebo.||2.74|0.70|0.356
91590784|NCT02281357|183071541|SUPERIORITY||Rate Ratio|0.8||||0.186|TWO_SIDED|95.0|0.57|1.12|||Negative binomial||Treatment group, OCS dose at baseline, and number of exacerbations in the previous year are included in the model as covariates.|Comparison of AAER: tralokinumab vs placebo.||1.12|0.57|0.186
91590785|NCT01162239|183071547|OTHER|||||||0.62|||||||Chi-squared|||||||0.62
91590786|NCT01162239|183071548|OTHER|||||||0.91|||||||Chi-squared|||||||0.91
91590787|NCT05390580|183071549|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||Repeated measures were analyzed with longitudinal mixed-effects models (FDA guidance), using subject as a random effect. This accounted for irregular timing, missing data, and time-varying covariates. Models included treatment, time since last known normal, and their interaction; quadratic time terms captured U-shaped cytokine/WBC patterns. Interaction p-values tested trajectory differences between taVNS and sham.||||0.24
91590788|NCT05390580|183071550|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Repeated measures were analyzed with longitudinal mixed-effects models (FDA guidance), using subject as a random effect. This accounted for irregular timing, missing data, and time-varying covariates. Models included treatment, time since last known normal, and their interaction; quadratic time terms captured U-shaped cytokine/WBC patterns. Interaction p-values tested trajectory differences between taVNS and sham.||||0.0001
91782098|NCT00473382|183443887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||<|0.0001|TWO_SIDED|95.0|5.4|11.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||11.5|5.4|<0.0001
91590789|NCT05390580|183071551|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||Repeated measures were analyzed with longitudinal mixed-effects models (FDA guidance), using subject as a random effect. This accounted for irregular timing, missing data, and time-varying covariates. Models included treatment, time since last known normal, and their interaction; quadratic time terms captured U-shaped cytokine/WBC patterns. Interaction p-values tested trajectory differences between taVNS and sham.||||0.26
91590790|NCT05390580|183071552|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Repeated measures were analyzed with longitudinal mixed-effects models (FDA guidance), using subject as a random effect. This accounted for irregular timing, missing data, and time-varying covariates. Models included treatment, time since last known normal, and their interaction; quadratic time terms captured U-shaped cytokine/WBC patterns. Interaction p-values tested trajectory differences between taVNS and sham.||||0.14
91590791|NCT05390580|183071554|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|||Repeated measures were analyzed with longitudinal mixed-effects models (FDA guidance), using subject as a random effect. This accounted for irregular timing, missing data, and time-varying covariates. Models included treatment, time since last known normal, and their interaction; linearly for in-hospital NIHSS scores based on panel data plots. Interaction terms were utilized to delineate differences amongst trajectories of the outcome of interest.||||0.69
91590792|NCT05390580|183071555|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Estimated using a mixed model that includes a random effect for person, based on actual day of the mRS, 90 day assessment. Restricted to participants who survived to an mRS assessment for day 90 , leaving 14 participants (28 mRS scores) in the treatment group and 17 participants (34 mRS scores) in the sham group.||||0.48
91590793|NCT05390580|183071556|EQUIVALENCE|Here we were testing if there were any safety differences based on treatment. This was a pilot exploratory trial, for which we may be underpowered.||||||0.49|||||||Regression, Logistic|||To assess our dichotomous safety endpoints, we used logistic regression models constructed to assess differences in hypotension.||||0.49
91648216|NCT01872689|183189062|SUPERIORITY||Median Difference (Final Values)|0.54171|STANDARD_ERROR_OF_MEAN|1.05201||0.6075|TWO_SIDED|95.0|-1.54|2.62|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.62|-1.54|0.6075
91709135|NCT03035916|183311328|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
91648217|NCT01872689|183189062|SUPERIORITY||Mean Difference (Final Values)|0.18203|STANDARD_ERROR_OF_MEAN|0.65206||0.7803|TWO_SIDED|95.0|-1.1|1.47|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||1.47|-1.10|0.7803
91590794|NCT05390580|183071557|EQUIVALENCE|Here we were testing if there were any safety differences based on treatment. This was a pilot exploratory trial, for which we may be underpowered.||||||0.66|||||||Regression, Logistic|||To assess our dichotomous safety endpoints, we used logistic regression models constructed to assess differences in bradycardia.||||0.66
91590795|NCT00823303|183071558|NON_INFERIORITY_OR_EQUIVALENCE|On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.||||||0.36|||||||Fisher Exact|||||||0.36
91590796|NCT02877927|183071559|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|5.0|||||TWO_SIDED|95.0|-0.2|10.3|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||10.3|-0.2|
91590797|NCT02877927|183071560|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|3.3|||||TWO_SIDED|95.0|-2.2|8.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.9|-2.2|
91590798|NCT02877927|183071561|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.3|||||TWO_SIDED|95.0|-0.6|5.6|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||5.6|-0.6|
91590799|NCT01791803|183071579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.6|||||TWO_SIDED|95.0|1.1|11.4||||||||11.4|1.1|
91590800|NCT01791803|183071579|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.4|||||TWO_SIDED|95.0|1.04|9.7||||||||9.7|1.04|
91648218|NCT01872689|183189064|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0972|TWO_SIDED|95.0|0.39|1.09|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.09|0.39|0.0972
91782099|NCT00473382|183443887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||<|0.0001|TWO_SIDED|95.0|6.4|13.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.3|6.4|<0.0001
91590801|NCT01791803|183071580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.8|6.2||||Adjusted for gender, marital status, diagnosis at enrollment.||||6.2|0.8|
91590802|NCT01791803|183071580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.2|10.0||||||||10|1.2|
91590803|NCT01791803|183071581|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis||||< 0.001
91590804|NCT01791803|183071581|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness||||0.07
91590805|NCT02060383|183071608|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.63|0.08|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c \<7% vs ≥7%) as fixed effects.|All Patients||0.08|-0.63|
91590806|NCT02060383|183071608|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.96|0.95|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Cushing's Disease||0.95|-0.96|
91590807|NCT02060383|183071608|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.74|0.02|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Acromegaly||0.02|-0.74|
91590808|NCT03426787|183071615|SUPERIORITY||Mean Difference (Final Values)|-12.30216|||<|0.001|TWO_SIDED|95.0|-18.95|-5.6531|||t-test, 2 sided|||||-5.6531|-18.95|<0.001
91590809|NCT03426787|183071616|SUPERIORITY||Mean Difference (Final Values)|-0.4717||||0.0463|TWO_SIDED|95.0|-0.9355|-0.00793|||t-test, 2 sided|||||-0.00793|-0.9355|0.0463
91590810|NCT03426787|183071617|SUPERIORITY||Median Difference (Final Values)|-1.936|||>|0.05|TWO_SIDED|95.0|-7.4086|3.5365|||t-test, 2 sided|||||3.5365|-7.4086|>0.05
91648219|NCT01872689|183189064|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9344|TWO_SIDED|95.0|0.72|1.42|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.42|0.72|0.9344
91648220|NCT01872689|183189065|SUPERIORITY||Median Difference (Final Values)|28.12302|STANDARD_ERROR_OF_MEAN|49.47253||0.5707|TWO_SIDED|95.0|-69.8|126.04|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||126.04|-69.80|0.5707
91709136|NCT03035916|183311328|OTHER|||||||0.058|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.058
91590811|NCT00257166|183071625|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-5.22|STANDARD_ERROR_OF_MEAN|1.48||0.0005|TWO_SIDED|95.0|-8.12|-2.31|||ANCOVA|||Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-2.31|-8.12|0.0005
91590812|NCT00257166|183071626|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2545|STANDARD_ERROR_OF_MEAN|0.9422||0.0006|TWO_SIDED|95.0|-5.1045|-1.4046|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4046|-5.1045|0.0006
91590813|NCT00257166|183071626|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5857|STANDARD_ERROR_OF_MEAN|1.4184||0.0117|TWO_SIDED|95.0|-6.3705|-0.8009|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.8009|-6.3705|0.0117
91590814|NCT00257166|183071626|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.8665|STANDARD_ERROR_OF_MEAN|1.7154||0.0047|TWO_SIDED|95.0|-8.2345|-1.4985|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4985|-8.2345|0.0047
91590815|NCT00257166|183071627|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3754|STANDARD_ERROR_OF_MEAN|0.0989||0.0002|TWO_SIDED|95.0|-0.5696|-0.1812|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.1812|-0.5696|0.0002
91590816|NCT00257166|183071627|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5596|STANDARD_ERROR_OF_MEAN|0.1355|<|0.0001|TWO_SIDED|95.0|-0.8256|-0.2936|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.2936|-0.8256|<0.0001
91590817|NCT00257166|183071627|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6798|STANDARD_ERROR_OF_MEAN|0.1643|<|0.0001|TWO_SIDED|95.0|-1.0024|-0.3572|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3572|-1.0024|<0.0001
91590818|NCT00257166|183071627|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6884|STANDARD_ERROR_OF_MEAN|0.1761||0.0001|TWO_SIDED|95.0|-1.0342|-0.3426|||ANCOVA|||Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3426|-1.0342|0.0001
91590819|NCT00257166|183071628|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.18|-0.34|||ANCOVA|||Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.||-0.34|-1.18|0.0004
91590820|NCT02592551|183071629|OTHER||Median Difference (Final Values)|8.6||||0.109|TWO_SIDED||||||Wilcoxon signed rank test|||Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab||||0.109
91590821|NCT02592551|183071630|OTHER|Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab||||||1|||||||Wilcoxon signed rank test|||||||1
91590822|NCT02592551|183071631|OTHER|||||||0.461|||||||Wilcoxon signed rank test|||Compare tumor expression programmed death-ligand 1 (PD-L1) before and after treatment with combination MEDI-4736 and Tremelimumab||||0.461
91590823|NCT02592551|183071632|OTHER|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg (ratio of CD8/treg) after MEDI-4736 and Tremelimumab, and after MEDI4736 alone||||0.954
91648221|NCT01872689|183189065|SUPERIORITY||Mean Difference (Final Values)|21.72972|STANDARD_ERROR_OF_MEAN|31.68767||0.4934|TWO_SIDED|95.0|-40.65|84.11|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||84.11|-40.65|0.4934
91590824|NCT02592551|183071633|OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group||||0.799
91590825|NCT02592551|183071636|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone||||0.418
91590826|NCT02592551|183071637|OTHER|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and before and at day 1 of untreated||||0.932
91590827|NCT00525044|183071663|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.028||0.0156|TWO_SIDED|95.0|-0.12|-0.01|||ANOVA||Treatment differences (Ambroxol- Placebo)|"Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.01|-0.12|0.0156
91590828|NCT00525044|183071664|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0|-0.4|0.1280
91521405|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.446|TWO_SIDED|95.0|-109.0|48.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||48|-109|0.446
91521406|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.0||||0.157|TWO_SIDED|95.0|-22.0|137.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||137|-22|0.157
91521407|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.826|TWO_SIDED|95.0|-93.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||74|-93|0.826
91521408|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.773||95.0|-95.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||70|-95|0.773
91521409|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|47.0||||0.277|TWO_SIDED|95.0|-38.0|131.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||131|-38|0.277
91521410|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.0||||0.319|TWO_SIDED|95.0|-43.0|132.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||132|-43|0.319
91521411|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.716|TWO_SIDED|95.0|-71.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||103|-71|0.716
91521412|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.098|TWO_SIDED|95.0|-14.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-14|0.098
91521413|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.832|TWO_SIDED|95.0|-80.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||100|-80|0.832
91521414|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.0||||0.579|TWO_SIDED|95.0|-64.0|114.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||114|-64|0.579
91521415|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|42.0||||0.369|TWO_SIDED|95.0|-49.0|133.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||133|-49|0.369
91521416|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0||||0.487|TWO_SIDED|95.0|-121.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||58|-121|0.487
91521417|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.887|TWO_SIDED|95.0|-82.0|95.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||95|-82|0.887
91590829|NCT00525044|183071664|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
91648222|NCT01872689|183189066|SUPERIORITY||Median Difference (Final Values)|-2.10204|STANDARD_ERROR_OF_MEAN|2.41325||0.3854|TWO_SIDED|95.0|-6.88|2.68|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.68|-6.88|0.3854
91648223|NCT01872689|183189066|SUPERIORITY||Mean Difference (Final Values)|-0.16313|STANDARD_ERROR_OF_MEAN|1.37698||0.9057|TWO_SIDED|95.0|-2.87|2.55|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.55|-2.87|0.9057
91648224|NCT01872689|183189068|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4433|TWO_SIDED|95.0|0.54|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.54|0.4433
91790188|NCT00308581|183459527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.696||95.0|0.7|1.7||Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).|Regression, Logistic||Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).|With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.||1.7|0.7|0.696
91590830|NCT00525044|183071664|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
91590831|NCT00525044|183071664|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
91590832|NCT00525044|183071665|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.1280
91590833|NCT00525044|183071665|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
91590834|NCT00525044|183071665|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
91590835|NCT00525044|183071665|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
91590836|NCT00525044|183071666|OTHER|||||||0.9939|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.9939
91590837|NCT00525044|183071666|OTHER|||||||0.5552|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.5552
91590838|NCT00525044|183071667|OTHER|||||||0.0343|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0343
91590839|NCT00525044|183071667|OTHER|||||||0.0119|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0119
91648225|NCT01872689|183189070|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.9366|TWO_SIDED|95.0|0.21|5.3|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||5.30|0.21|0.9366
91648226|NCT01872689|183189070|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.1346|TWO_SIDED|95.0|0.16|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.16|0.1346
91648227|NCT01872689|183189072|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6815|TWO_SIDED|95.0|0.52|1.54|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.54|0.52|0.6815
91648228|NCT01872689|183189074|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.5685|TWO_SIDED|95.0|0.23|2.26|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||2.26|0.23|0.5685
91648229|NCT01872689|183189074|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.1976|TWO_SIDED|95.0|0.37|1.23|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.23|0.37|0.1976
91709137|NCT03035916|183311328|OTHER|||||||0.166|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.166
91648230|NCT01042977|183189106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0489|<|0.0001|TWO_SIDED|95.0|-0.5|-0.3||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.30|-0.50|<0.0001
91648231|NCT01042977|183189107|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.0|||<|0.0001|TWO_SIDED|95.0|4.3|9.8||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||9.8|4.3|<0.0001
91648232|NCT01042977|183189108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.1957|<|0.0001|TWO_SIDED|95.0|-2.31|-1.54||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.54|-2.31|<0.0001
91648233|NCT01042977|183189109|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6|STANDARD_ERROR_OF_MEAN|2.149|<|0.0001|TWO_SIDED|95.0|9.4|17.8||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline total body weight and age stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||17.8|9.4|<0.0001
91648234|NCT01042977|183189110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.7977||0.0007|TWO_SIDED|95.0|-4.28|-1.15||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.15|-4.28|0.0007
91648235|NCT01042977|183189111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|0.7983||0.0002|TWO_SIDED|95.0|-4.59|-1.46||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.46|-4.59|0.0002
91648236|NCT01042977|183189112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.9746||0.0004|TWO_SIDED|95.0|-5.35|-1.53||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.53|-5.35|0.0004
91648237|NCT02499354|183189113|SUPERIORITY|||||||0.2742|||||||t-test, 1 sided|||||||0.2742
91648238|NCT02499354|183189114|SUPERIORITY|||||||0.55|||||||Chi-squared|||||||0.55
91648239|NCT01677910|183189120|SUPERIORITY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.283|-0.337|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.337|-1.283|< 0.001
91790189|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-5.0|11.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||11.2|-5.0|0.78
91648240|NCT01677910|183189120|SUPERIORITY||Mean Difference (Net)|-0.833|||<|0.001|TWO_SIDED|95.0|-1.292|-0.374|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.374|-1.292|< 0.001
91648241|NCT04132232|183189140|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
91648242|NCT00755937|183189141|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|66.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
91648243|NCT00755937|183189142|SUPERIORITY_OR_OTHER||percentage (no inferential test)|72.5||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
91648244|NCT00755937|183189143|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
91648245|NCT00755937|183189144|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|60.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
91648246|NCT00755937|183189145|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|64.8||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
91648247|NCT00755937|183189146|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
91648248|NCT03547531|183189154|OTHER||||||>|0.05|||||||t-test, 2 sided|independent t-test||Null hypothesis: the mean of plaque index between groups are not different|the statistical analysis used in this study is independent t-test|||>0.05
91648249|NCT03547531|183189155|OTHER|this data is analyzed using independent t-test|||||>|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||>0.05
91648250|NCT03547531|183189156|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of plaque index between groups|this data is analyzed using independent t-test|||<0.05
91590840|NCT02039726|183071675|OTHER||Hazard Ratio (HR)|0.758||||0.0185|TWO_SIDED|95.0|0.584|0.983|||P-value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||0.983|0.584|0.0185
91590841|NCT02039726|183071676|OTHER||Hazard Ratio (HR)|0.898||||0.2034|TWO_SIDED|95.0|0.697|1.157|||P value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||1.157|0.697|0.2034
91590842|NCT00713817|183071690|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.89||||0.273|TWO_SIDED|95.0|-0.78|2.56|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||2.56|-0.78|0.273
91590843|NCT00713817|183071691|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.62||||0.296|TWO_SIDED|95.0|-4.51|13.75|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||13.75|-4.51|0.296
91590844|NCT00713817|183071692|SUPERIORITY_OR_OTHER_LEGACY||Chi-square|0.048||||0.826||95.0|||||Log Rank|||Time to treatment failure was analysed using Kaplan-Meier Survival analysis methodology. The difference in loss of response cumulative distribution function between treatments was assessed using the Hodges-Lehmann estimate.||||0.826
91590845|NCT00713817|183071693|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.14||||0.54|TWO_SIDED|95.0|-39.7|9.62|||Hodges-Lehmann|||The difference in loss of response cumulative distribution functions between treatments was assessed using the Wilcoxon test with an estimate of the median difference between groups in response level (percent change from baseline) provided by the Hodges-Lehmann estimator.||9.62|-39.7|0.54
91590846|NCT00713817|183071694|SUPERIORITY_OR_OTHER_LEGACY||Estimate mean treatment difference|-0.08||||0.902|TWO_SIDED|95.0|-1.45|1.29|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||1.29|-1.45|0.902
91590847|NCT00713817|183071695|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.557||||0.603|TWO_SIDED|95.0|0.293|8.261|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated the parent Randomised Controlled Trials (RCTs). The interaction between treatment group and parent RCTs was investigated, but was dropped from the model if found to have little influence. The test was performed at the 10% significance level. The final model was then treatment group and parent RCTs, i.e. the treatment effect was adjusted for parent RCTs baseline.||8.261|0.293|0.603
91590848|NCT01817907|183071699|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
91590849|NCT01086410|183071727|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.99|||||TWO_SIDED|95.0|0.87|1.12|||||Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.12|0.87|
91648251|NCT03547531|183189157|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||<0.05
91590850|NCT01086410|183071727|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.97|||||TWO_SIDED|95.0|0.86|1.1|||||Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.10|0.86|
91590851|NCT01086410|183071727|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||0.41|0.28|
91590852|NCT00621751|183071767|OTHER||Median Difference (Final Values)|36.7||||0.6|TWO_SIDED|||||CBZ (up to 800 mg daily) vs placebo significantly improves behavior (Rasch NPI irritability \& aggression rated by observer) baseline to day-42 among individuals \>6 months post-traumatic brain injury and moderate-severe irritability.|ANCOVA|||The primary outcome was a composite measure of observer-rated NPI-I \& NPI-A domains transformed to a Rasch logit scale ranging 0 (best) to 100 (worse) units (i.e., observer-rated NPI-I/A Rasch construct scores). Mean day-42 observer-rated NPI-I/A Rasch construct scores were compared between the placebo vs. carbamazepine groups using ANCOVA with baseline score as covariate.||||0.60
91590853|NCT00621751|183071768|OTHER|A prespecified secondary analysis compared proportions of participants that experienced a decrease of \> 1 MCID in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.|||||<|0.05|||||||ANCOVA|||||||< .05
91590854|NCT05097716|183071796|EQUIVALENCE|90% CI|ratio of adjusted geometric means|103.01|||||TWO_SIDED|90.0|96.66|109.77|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||109.77|96.66|
91648252|NCT02117479|183189165|OTHER||Hazard Ratio (HR)|0.969|||||TWO_SIDED|95.0|0.747|1.256||||||||1.256|0.747|
91590855|NCT05097716|183071797|EQUIVALENCE|90% CI|ratio of adjusted geometric means|99.05|||||TWO_SIDED|90.0|92.01|106.62|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||106.62|92.01|
91590856|NCT00791258|183071815|SUPERIORITY_OR_OTHER||Percentage|75.8|||||TWO_SIDED|95.0|73.0|78.5||||||||78.5|73.0|
91590857|NCT00791258|183071816|SUPERIORITY_OR_OTHER||Percentage|84.3|||||TWO_SIDED|95.0|81.8|86.5||||||||86.5|81.8|
91648253|NCT02117479|183189166|OTHER||Hazard Ratio (HR)|1.056|||||TWO_SIDED|95.0|0.827|1.348||||||||1.348|0.827|
91709138|NCT03035916|183311328|OTHER|||||||0.288|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.288
91648254|NCT01223196|183189200|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.||Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).||||0.04
91648255|NCT01223196|183189200|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.||||||0.05
91782100|NCT00473382|183443888|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|21.4||||0.0002|TWO_SIDED|95.0|10.8|31.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||31.9|10.8|0.0002
91790190|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.75|TWO_SIDED|95.0|-4.6|10.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||10.7|-4.6|0.75
91590858|NCT00791258|183071817|SUPERIORITY_OR_OTHER||Percentage|71.3|||||TWO_SIDED|95.0|68.3|74.1||||||12 week analysis||74.1|68.3|
91590859|NCT00791258|183071817|SUPERIORITY_OR_OTHER||Percentage|84.8|||||TWO_SIDED|95.0|82.4|87.0||||||20 week analysis||87.0|82.4|
91590860|NCT00791258|183071818|SUPERIORITY_OR_OTHER||Median Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-13.8|||t-test, 1 sided|||4 week analysis||-13.8|-15.4|<0.0001
91590861|NCT00791258|183071818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.6|||<|0.0001|TWO_SIDED|95.0|-17.7|-15.7|||t-test, 1 sided|||8 week analysis||-15.7|-17.7|<0.0001
91590862|NCT00791258|183071818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.8|||<|0.0001|TWO_SIDED|95.0|-22.7|-20.9|||t-test, 1 sided|||12 week analysis||-20.9|-22.7|<0.0001
91590863|NCT00791258|183071818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.0|||<|0.0001|TWO_SIDED|95.0|-27.0|-25.0|||t-test, 1 sided|||16 week analysis||-25.0|-27.0|<0.0001
91590864|NCT00791258|183071818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-27.8|-25.7|||t-test, 1 sided|||20 week analysis||-25.7|-27.8|<0.0001
91590865|NCT00791258|183071819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1|||<|0.0001|TWO_SIDED|95.0|-8.6|-7.6|||t-test, 1 sided|||4 week analysis||-7.6|-8.6|<0.0001
91790191|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.3||0.08|TWO_SIDED|95.0|-0.6|13.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.7|-0.6|0.08
91590866|NCT00791258|183071819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|||<|0.0001|TWO_SIDED|95.0|-9.7|-8.5|||t-test, 1 sided|||8 week analysis||-8.5|-9.7|<0.0001
91590867|NCT00791258|183071819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-11.4|||t-test, 1 sided|||12 week analysis||-11.4|-12.5|<0.0001
91590868|NCT00791258|183071819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.2|-14.0|||t-test, 1 sided|||16 week analysis||-14.0|-15.2|<0.0001
91590869|NCT00791258|183071819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.5||||0.0001|TWO_SIDED|95.0|-15.1|-13.8|||t-test, 1 sided|||20 week analysis||-13.8|-15.1|0.0001
91590870|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.8|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.4|||t-test, 1 sided|||Mean 24-hour systolic blood pressure||-13.4|-16.2|<0.0001
91590871|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.3|||<|0.0001|TWO_SIDED|95.0|-17.8|-14.8|||t-test, 1 sided|||Mean daytime systolic blood pressure||-14.8|-17.8|<0.0001
91590872|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.5|||<|0.0001|TWO_SIDED|95.0|-14.1|-10.8|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-10.8|-14.1|<0.0001
91590873|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.6|||t-test, 1 sided|||systolic blood pressure during last 2 hours of dose||-11.6|-15.7|<0.0001
91590874|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.0001|TWO_SIDED|95.0|-14.7|-11.2|||t-test, 1 sided|||systolic blood pressure during last 4 hours of dose||-11.2|-14.7|<0.0001
91590875|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.6|||<|0.0001|TWO_SIDED|95.0|-14.3|-10.9|||t-test, 1 sided|||systolic blood pressure during last 6 hours of dose||-10.9|-14.3|<0.0001
91590876|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4|||<|0.0001||95.0|-10.3|-8.5|||t-test, 1 sided|||Mean 24-hour diastolic blood pressure||-8.5|-10.3|<0.0001
91590877|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.6|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-9.6|-11.7|<0.0001
91648256|NCT01223196|183189201|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.||Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
91709139|NCT03035916|183311328|OTHER|||||||0.299|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.299
91590878|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.6|||<|0.0001|TWO_SIDED|95.0|-8.8|-6.4|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-6.4|-8.8|<0.0001
91590879|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|||<|0.0001||95.0|-10.0|-7.2|||t-test, 1 sided|||diastolic blood pressure during last 2 hours of dose||-7.2|-10.0|<0.0001
91590880|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.8|||t-test, 1 sided|||diastolic blood pressure during last 4 hours of dose||-6.8|-9.2|<0.0001
91590881|NCT00791258|183071831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.7|||<|0.0001||95.0|-8.8|-6.6|||t-test, 1 sided|||diastolic blood pressure during last 6 hours of dose||-6.6|-8.8|<0.0001
91590882|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.0001|TWO_SIDED|95.0|-22.6|-19.3|||t-test, 1 sided|||24-hour mean systolic blood pressure||-19.3|-22.6|<0.0001
91590883|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.2|||<|0.0001|TWO_SIDED|95.0|-25.1|-21.4|||t-test, 1 sided|||Mean daytime systolic blood pressure||-21.4|-25.1|<0.0001
91590884|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.5|||<|0.0001|TWO_SIDED|95.0|-19.4|-15.6|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-15.6|-19.4|<0.0001
91590885|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4|||t-test, 1 sided|||Systolic blood pressure - last 2 hours of dose||-17.4|-21.7|<0.0001
91590886|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.2|||<|0.0001|TWO_SIDED|95.0|-20.2|-16.3|||t-test, 1 sided|||Systolic blood pressure - last 4 hours of dose||-16.3|-20.2|<0.0001
91590887|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.7|-16.0|||t-test, 1 sided|||Systolic blood pressure - last 6 hours of dose||-16.0|-19.7|<0.0001
91590888|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.3|||<|0.0001|TWO_SIDED|95.0|-14.4|-12.2|||t-test, 1 sided|||24-hour mean diastolic blood pressure||-12.2|-14.4|<0.0001
91648257|NCT01223196|183189201|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.||Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1||||<0.05
91590889|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.8|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-13.8|-16.2|<0.0001
91590890|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-9.8|-12.4|<0.0001
91590891|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.3|||<|0.0001|TWO_SIDED|95.0|-13.8|-10.8|||t-test, 1 sided|||Diastolic blood pressure - last 2 hours of dose||-10.8|-13.8|<0.0001
91590892|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.6|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.2|||t-test, 1 sided|||Diastolic blood pressure - last 4 hours of dose||-10.2|-12.9|<0.0001
91590893|NCT00791258|183071832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-12.6|-10.0|||t-test, 1 sided|||Diastolic blood pressure - last 6 hours of dose||-10.0|-12.6|<0.0001
91590894|NCT00314249|183071880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.38||||||95.0|-8.56|-4.19|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-4.19|-8.56|
91590895|NCT00314249|183071881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||||95.0|-0.69|-0.38|||ANOVA|||This parameter was analyzed using an ANOVA model with treatment group and study center as factors.||-0.38|-0.69|
91590896|NCT00314249|183071882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||||95.0|-3.27|-0.11|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-0.11|-3.27|
91590897|NCT00314249|183071883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001||95.0|1.45|2.94||Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.||2.94|1.45|<0.001
91782101|NCT00473382|183443888|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|27.1|||<|0.0001|TWO_SIDED|95.0|16.4|37.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||37.9|16.4|<0.0001
91790192|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4||0.17|TWO_SIDED|95.0|-1.6|13.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.2|-1.6|0.17
91590898|NCT00314249|183071884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86|||<|0.001||95.0|1.38|2.51||Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.||2.51|1.38|<0.001
91709140|NCT03035916|183311328|OTHER|||||||0.051|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.051
91782102|NCT00473382|183443889|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.1||||0.0119|TWO_SIDED|95.0|1.7|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|1.7|0.0119
91590899|NCT00314249|183071885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||||95.0|0.86|2.44|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||2.44|0.86|
91590900|NCT01372150|183071895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.226|TWO_SIDED|95.0|-1.06|4.48|||Mixed-effects model for repeated measure|Mixed-effects model for repeated measures (MMRM)|Adjusted mean difference = placebo - fluoxetine|Fluoxetine versus Placebo||4.48|-1.06|0.226
91590901|NCT01372150|183071895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.739|TWO_SIDED|95.0|-3.23|2.3|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||2.30|-3.23|0.739
91590902|NCT01372150|183071896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.224|TWO_SIDED|95.0|-0.11|0.46|||MMRM||Adjusted mean difference = Placebo - Fluoxetine|Fluoxetine versus Placebo||0.46|-0.11|0.224
91590903|NCT01372150|183071896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.944|TWO_SIDED|95.0|-0.29|0.27|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||0.27|-0.29|0.944
91590904|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.924||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 1||||0.924
91590905|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.698||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 1||||0.698
91590906|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.214||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 2||||0.214
91590907|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.113||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 2||||0.113
91782103|NCT00473382|183443889|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|4.5||||0.1384|TWO_SIDED|95.0|-1.2|10.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||10.1|-1.2|0.1384
91590908|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.314||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 3||||0.314
91590909|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.659||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 3||||0.659
91590910|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.577||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 4||||0.577
91590911|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.187||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 4||||0.187
91590912|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.051||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 6||||0.051
91590913|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.266||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 6||||0.266
91590914|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.095||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 8||||0.095
91590915|NCT01372150|183071897|SUPERIORITY_OR_OTHER|||||||0.852||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 8||||0.852
91590916|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.186|TWO_SIDED|95.0|0.226|1.335|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 1||1.335|0.226|0.186
91709141|NCT03035916|183311328|OTHER|||||||0.186|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.186
91590917|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.984|TWO_SIDED|95.0|0.382|2.567|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 1||2.567|0.382|0.984
91590918|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.795||||0.462|TWO_SIDED|95.0|0.431|1.465|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 2||1.465|0.431|0.462
91590919|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.726||||0.297|TWO_SIDED|95.0|0.399|1.324|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 2||1.324|0.399|0.297
91590920|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.194|TWO_SIDED|95.0|0.391|1.21|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 3||1.210|0.391|0.194
91590921|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732||||0.272|TWO_SIDED|95.0|0.419|1.277|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 3||1.277|0.419|0.272
91590922|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.748||||0.313|TWO_SIDED|95.0|0.426|1.314|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 4||1.314|0.426|0.313
91590923|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.157|TWO_SIDED|95.0|0.376|1.171|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 4||1.171|0.376|0.157
91590924|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.072|TWO_SIDED|95.0|0.319|1.05|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 6||1.050|0.319|0.072
91590925|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.135|TWO_SIDED|95.0|0.356|1.149|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 6||1.149|0.356|0.135
91590926|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.465||||0.017|TWO_SIDED|95.0|0.249|0.871|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 8||0.871|0.249|0.017
91590927|NCT01372150|183071898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.751||||0.343|TWO_SIDED|95.0|0.415|1.357|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 8||1.357|0.415|0.343
91590928|NCT01006265|183071928|SUPERIORITY||Treatment effect (rate ratio)|0.226|||<|0.0001|TWO_SIDED|95.0|0.133|0.384|||Negative binomial regression model|||||0.384|0.133|<0.0001
91590929|NCT01006265|183071928|SUPERIORITY||Treatment effect (rate ratio)|0.17|||<|0.0001|TWO_SIDED|95.0|0.1|0.289|||Negative binomial regression model|||||0.289|0.100|<0.0001
91590930|NCT01006265|183071928|SUPERIORITY||Treatment effect (rate ratio)|0.566||||0.0318|TWO_SIDED|95.0|0.337|0.952|||Negative binomial regression model|||||0.952|0.337|0.0318
91590931|NCT01177384|183071931|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.62|||<|0.001|TWO_SIDED|95.0|-0.79|-0.44||The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.|ANCOVA|||||-0.44|-0.79|<.001
91590932|NCT01177384|183071932|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.8|-7.0||The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.|ANCOVA|||||-7.0|-21.8|<.001
91590933|NCT00955279|183071935|SUPERIORITY_OR_OTHER|||||||0.543|||||||ANCOVA|||||||0.543
91590934|NCT00955279|183071935|SUPERIORITY_OR_OTHER|||||||0.126|||||||ANCOVA|||||||0.126
91590935|NCT00955279|183071936|SUPERIORITY_OR_OTHER|||||||0.896|||||||Linear Contrasts Test|||||||0.896
91590936|NCT00955279|183071936|SUPERIORITY_OR_OTHER|||||||0.063|||||||Linear Contrasts Test|||||||0.063
91590937|NCT00955279|183071937|SUPERIORITY_OR_OTHER|||||||0.374|||||||Linear Contrasts Test|||||||0.374
91590938|NCT00955279|183071937|SUPERIORITY_OR_OTHER|||||||0.073|||||||Linear Contrasts Test|||||||0.073
91590939|NCT00955279|183071938|SUPERIORITY_OR_OTHER|||||||0.1931|||||||Fisher Exact|||||||0.1931
91590940|NCT00955279|183071938|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Fisher Exact|||||||0.2772
91590941|NCT00955279|183071939|SUPERIORITY_OR_OTHER|||||||0.451|||||||Linear Contrast Test|||||||0.451
91590942|NCT00955279|183071939|SUPERIORITY_OR_OTHER|||||||0.546|||||||Linear Contrast Test|||||||0.546
91590943|NCT00232141|183072043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3914||95.0|-0.83|0.32||The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.|ANCOVA|||Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment \& placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, \& a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint||0.32|-0.83|0.3914
91590944|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0131||95.0|-0.81|-0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.10|-0.81|0.0131
91648258|NCT01223196|183189202|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.||Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
91648259|NCT02629133|183189203|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.560
91782104|NCT00473382|183443890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.0102|TWO_SIDED|95.0|2.0|14.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||14.6|2.0|0.0102
91782105|NCT00473382|183443890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.0005|TWO_SIDED|95.0|5.1|17.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||17.3|5.1|0.0005
91590945|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.24||0.0393||95.0|-0.96|-0.02||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.02|-0.96|0.0393
91590946|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0554||95.0|-1.08|0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||0.01|-1.08|0.0554
91590947|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.29||0.1513||95.0|-0.99|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.15|-0.99|0.1513
91590948|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.3||0.3345||95.0|-0.89|0.3||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.30|-0.89|0.3345
91590949|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0879||95.0|-1.13|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.08|-1.13|0.0879
91590950|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.32||0.0307||95.0|-1.32|-0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.07|-1.32|0.0307
91590951|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.31||0.0156||95.0|-1.36|-0.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.14|-1.36|0.0156
91590952|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.32||0.0981||95.0|-1.15|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.15|0.0981
91590953|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.306||95.0|-0.93|0.29||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.29|-0.93|0.3060
91590954|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.33||0.1874||95.0|-1.08|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.21|-1.08|0.1874
91648260|NCT02629133|183189203|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months||||0.760
91648261|NCT02629133|183189204|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
91648262|NCT02629133|183189204|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.||||0.029
91648263|NCT02629133|183189205|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.325|TWO_SIDED|95.0|-4.5|13.5||We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.|Mixed Models Analysis|||||13.5|-4.5|0.325
91648264|NCT02629133|183189206|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.192|TWO_SIDED|95.0|-0.61|2.98||We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||Higher scores represent more cyber-stalking over follow-up.|||2.98|-0.61|0.192
91648265|NCT02629133|183189207|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.119|TWO_SIDED|95.0|-3.24|0.38||We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.|Mixed Models Analysis||Higher is better (reflecting more safety behaviors used).|||0.38|-3.24|0.119
91648266|NCT02572427|183189214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||0.039
91648267|NCT02572427|183189215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91648268|NCT00386100|183189234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.305||No adjustment for multiple comparisons|ANCOVA|ANCOVA with terms for treatment, region, gender, and baseline value with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.305|-0.669|<0.0001
91648269|NCT00386100|183189235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||No adjustment for multiple comparisons|Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.30|-0.69|<0.0001
91648270|NCT00386100|183189236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.0046|TWO_SIDED|95.0|1.18|2.46||Hb1AC \<= 6.5%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32.|Odds of having an HbA1c \<= 6.5% at Week 80 on Avandamet compared to Metformin.|||2.46|1.18|0.0046
91648271|NCT00386100|183189236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.59|||<|0.0001|TWO_SIDED|95.0|1.75|3.81||Hb1AC \< 7%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32|Odds of having an HbA1c \<7% at Week 80 on Avandamet compared to Metformin|||3.81|1.75|<0.0001
91521418|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.0||||0.486|TWO_SIDED|95.0|-59.0|123.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||123|-59|0.486
91648272|NCT00386100|183189237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|||<|0.0001||95.0|-1.54|-0.77|||Repeated measures analysis|Terms for baseline, region, treatment, pre-screening Hb1Ac strata, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.77|-1.54|<0.0001
91648273|NCT00386100|183189238|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.425|-0.71||No adjustment for multiple comparisons|ANCOVA|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.710|-1.425|<0.001
91648274|NCT00386100|183189239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.47|||<|0.0001|TWO_SIDED|95.0|2.94|6.81||FPG \<=6.1 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32.|Odds of having an FPG \<=6.1 mmol/l at Week 80 on Avandamet compared to Metformin|||6.81|2.94|<0.0001
91648275|NCT00386100|183189239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.25|4.92||FPG \<=7 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac, and baseline with LOCF from Week 32.|Odds of having an FPG \<=7 mmol/l at Week 80 on Avandamet compared to Metformin|||4.92|2.25|<0.0001
91648276|NCT00386100|183189240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Regression, Cox|Cox proportional hazard regression with terms for treatment, region, baseline Hb1Ac strata, and gender||||0.74|0.45|<0.0001
91648277|NCT00386100|183189241|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.97||||0.0006|TWO_SIDED|95.0|2.522|9.526||Total cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||9.526|2.522|0.0006
91648278|NCT00386100|183189241|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.71||||0.056|TWO_SIDED|95.0|2.486|15.304||LDL cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||15.304|2.486|0.056
91648279|NCT00386100|183189241|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.58||||0.072|TWO_SIDED|95.0|-0.232|5.47||HDL cholesterol. No adjustment for multiple comparison. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||5.470|-0.232|0.072
91648280|NCT00386100|183189241|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.743||||0.835|TWO_SIDED|95.0|-6.056|8.035||Triglycerides. No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||8.035|-6.056|0.835
91709142|NCT03035916|183311328|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.555
91590955|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.1025||95.0|-1.22|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.11|-1.22|0.1025
91590956|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0662||95.0|-1.3|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||0.04|-1.30|0.0662
91590957|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.37||0.1856||95.0|-1.21|0.24||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.24|-1.21|0.1856
91648281|NCT00386100|183189242|SUPERIORITY_OR_OTHER||Percent difference from metformin|102.24|||<|0.0001|TWO_SIDED|95.0|79.23|128.19||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||128.19|79.23|<0.0001
91782106|NCT00473382|183443891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-111.8|||<|0.0001|TWO_SIDED|95.0|-151.6|-72.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-72.0|-151.6|<0.0001
91782107|NCT00473382|183443891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.2|||<|0.0001|TWO_SIDED|95.0|-169.7|-94.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-94.8|-169.7|<0.0001
91782108|NCT00473382|183443892|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-4.3||||0.0853|TWO_SIDED|95.0|-9.3|0.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.8|-9.3|0.0853
91790193|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.7||0.61|TWO_SIDED|95.0|-6.5|17.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||17.2|-6.5|0.61
91590958|NCT00232141|183072044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.7925||95.0|-0.66|0.5||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.50|-0.66|0.7925
91590959|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.1191||95.0|0.802|5.935||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||5.935|0.802|0.1191
91590960|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.5041||95.0|0.666|2.301||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||2.301|0.666|0.5041
91590961|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.6859||95.0|0.638|1.985||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||1.985|0.638|0.6859
91709143|NCT03035916|183311328|OTHER|||||||0.065|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.065
91590962|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.414||95.0|0.735|2.116||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.116|0.735|0.4140
91590963|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.7852||95.0|0.644|1.794||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.794|0.644|0.7852
91590964|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7399||95.0|0.654|1.817||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.817|0.654|0.7399
91590965|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.1055||95.0|0.913|2.701||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||2.701|0.913|0.1055
91590966|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.2107||95.0|0.829|2.401||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.401|0.829|0.2107
91782109|NCT00473382|183443892|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-5.8||||0.0073|TWO_SIDED|95.0|-9.8|-1.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.7|-9.8|0.0073
91790194|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|3.1||0.32|TWO_SIDED|95.0|-4.1|16.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||16.8|-4.1|0.32
91590967|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.527||95.0|0.697|2.046||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||2.046|0.697|0.5270
91590968|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.6845||95.0|0.513|1.546||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.546|0.513|0.6845
91590969|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7737||95.0|0.522|1.619||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||1.619|0.522|0.7737
91590970|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.8853||95.0|0.597|1.818||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||1.818|0.597|0.8853
91590971|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7712||95.0|0.612|1.946||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||1.946|0.612|0.7712
91590972|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9586||95.0|0.574|1.796||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||1.796|0.574|0.9586
91648282|NCT00386100|183189243|SUPERIORITY_OR_OTHER||Percent difference from metformin|-8.2||||0.138|TWO_SIDED|95.0|-18.04|2.82||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||2.82|-18.04|0.1380
91648283|NCT00386100|183189244|SUPERIORITY_OR_OTHER||Percent difference from metformin|-11.308||||0.0342|TWO_SIDED|95.0|-20.617|-0.899||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||-0.899|-20.617|0.0342
91648284|NCT00386100|183189245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.7||||0.0042|TWO_SIDED|95.0|-56.666|-0.99||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline.|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.99|-56.666|0.0042
91590973|NCT00232141|183072045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.3482||95.0|0.486|1.283||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.283|0.486|0.3482
91590974|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.1132||95.0|0.882|2.969||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||2.969|0.882|0.1132
91590975|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.4687||95.0|0.731|1.978||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||1.978|0.731|0.4687
91590976|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1546||95.0|0.877|2.375||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||2.375|0.877|0.1546
91590977|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.4216||95.0|0.7444|2.025||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.025|0.7444|0.4216
91590978|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7479||95.0|0.556|1.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.527|0.556|0.7479
91590979|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.3842||95.0|0.481|1.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.330|0.481|0.3842
91648285|NCT00386100|183189246|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.229||||0.0006|TWO_SIDED|95.0|-0.359|-0.099||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.099|-0.359|0.0006
91648286|NCT00386100|183189247|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.4||||0.7148|TWO_SIDED|95.0|-9.87|16.34||HOMA-B. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||16.34|-9.87|0.7148
91648287|NCT00386100|183189247|SUPERIORITY_OR_OTHER||percent difference from metformin|31.14|||<|0.001|TWO_SIDED|95.0|14.82|49.78||HOMA-S. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||49.78|14.82|<0.001
91648288|NCT00386100|183189248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.85||||0.319|TWO_SIDED|95.0|-79.035|240.744|||Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, pre-screening Hb1AC, time, and treatment by time interaction||||240.744|-79.035|0.319
91790195|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|2.8||0.03|TWO_SIDED|95.0|1.6|22.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||22.3|1.6|0.03
91590980|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.845||95.0|0.627|1.769||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||1.769|0.627|0.8450
91590981|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.864|2.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.527|0.864|0.1602
91590982|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6815||95.0|0.66|1.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||1.890|0.660|0.6815
91590983|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.5635||95.0|0.486|1.482||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.482|0.486|0.5635
91648289|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0012|TWO_SIDED|95.0|-3.5|-0.9||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.9|-3.5|0.0012
91709144|NCT03035916|183311328|OTHER|||||||0.168|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.168
91648290|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031|TWO_SIDED|95.0|-2.7|-0.6||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-2.7|0.0031
91648291|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0308|TWO_SIDED|95.0|-2.0|-0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-2.0|0.0308
91782110|NCT00473382|183443893|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|14.0||||0.0002|TWO_SIDED|95.0|6.8|21.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||21.1|6.8|0.0002
91590984|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.49||95.0|0.699|2.104||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||2.104|0.699|0.4900
91590985|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.856|2.575||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||2.575|0.856|0.1602
91590986|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5819||95.0|0.663|2.079||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||2.079|0.663|0.5819
91590987|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2796||95.0|0.768|2.432||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||2.432|0.768|0.2796
91590988|NCT00232141|183072046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.5437||95.0|0.534|1.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.390|0.534|0.5437
91590989|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.53||0.5425||95.0|-3.44|6.52||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Disturbance.||6.52|-3.44|0.5425
91590990|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.3184||95.0|-0.75|0.25||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Quantity||0.25|-0.75|0.3184
91590991|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.92||0.9886||95.0|-5.81|5.72||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Adequacy||5.72|-5.81|0.9886
91590992|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|2.51||0.5742||95.0|-3.53|6.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Awaken Short of Breath or with Headache||6.35|-3.53|0.5742
91590993|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.5775||95.0|-3.54|6.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Somnolence||6.33|-3.54|0.5775
91590994|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.34|STANDARD_ERROR_OF_MEAN|3.21||0.004||95.0|3.02|15.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Snoring||15.66|3.02|0.0040
91648292|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0954|TWO_SIDED|95.0|-3.7|0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.3|-3.7|0.0954
91709145|NCT03035916|183311328|OTHER|||||||0.739|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.739
91590995|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|1.98||0.5882||95.0|-2.83|4.97||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index I||4.97|-2.83|0.5882
91590996|NCT00232141|183072047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|1.89||0.4516||95.0|-2.3|5.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index II||5.14|-2.30|0.4516
91590997|NCT00232141|183072048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.39||0.5105||95.0|-0.51|1.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Anxiety||1.03|-0.51|0.5105
91590998|NCT00232141|183072048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.37||0.2513||95.0|-0.3|1.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Depression||1.14|-0.30|0.2513
91590999|NCT00232141|183072049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.27||0.5834||95.0|-0.38|0.67||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Severity Index||0.67|-0.38|0.5834
91591000|NCT00232141|183072049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.25||0.7783||95.0|-0.43|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Interference Index||0.57|-0.43|0.7783
91591001|NCT00232141|183072050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4776||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.34|-0.73|0.4776
91591002|NCT00232141|183072051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.0077
91591003|NCT00232141|183072052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3852||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.3852
91591004|NCT00232141|183072053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3097||95.0|-0.03|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Burning||0.10|-0.03|0.3097
91591005|NCT00232141|183072053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.6147||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pressing||0.04|-0.07|0.6147
91591006|NCT00232141|183072053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6838||95.0|-0.05|0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paroxysmal||0.07|-0.05|0.6838
91591007|NCT00232141|183072053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6479||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Evoked||0.04|-0.07|0.6479
91591008|NCT00232141|183072053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1849||95.0|-0.02|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paresthesia/dysesthesia||0.11|-0.02|0.1849
91591009|NCT00232141|183072053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5898||95.0|0.0|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Total Score||0|0|0.5898
91709146|NCT03035916|183311328|OTHER|||||||0.079|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.079
91709147|NCT03035916|183311329|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
91591010|NCT00232141|183072054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6865||95.0|-0.45|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Static mechanical allodynia||0.68|-0.45|0.6865
91591011|NCT00232141|183072054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3787||95.0|-0.71|0.27||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Dynamic mechanical allodynia||0.27|-0.71|0.3787
91591012|NCT00232141|183072054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35||0.7704||95.0|-0.79|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Punctate hyperalgesia testing area||0.59|-0.79|0.7704
91591013|NCT00232141|183072054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.33||0.6088||95.0|-0.82|0.48||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Temporal summation to tactile stimuli||0.48|-0.82|0.6088
91591014|NCT00232141|183072054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.33||0.3767||95.0|-0.93|0.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold allodynia testing area||0.35|-0.93|0.3767
91591015|NCT00232141|183072054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.38||0.7689||95.0|-0.64|0.86||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold hyperalgesia testing area||0.86|-0.64|0.7689
91591016|NCT00232141|183072055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.25||0.1277||95.0|-0.86|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.11|-0.86|0.1277
91591017|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0469||95.0|-0.71|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.00|-0.71|0.0469
91648293|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0015|TWO_SIDED|95.0|-4.7|-1.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.2|-4.7|0.0015
91790196|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|3.1||0.04|TWO_SIDED|95.0|0.5|21.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||21.8|0.5|0.04
91591018|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0067||95.0|-1.08|-0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.18|-1.08|0.0067
91591019|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.27||0.031||95.0|-1.1|-0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||-0.05|-1.10|0.0310
91591020|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.27||0.2088||95.0|-0.86|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.19|-0.86|0.2088
91591021|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1849||95.0|-0.87|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.17|-0.87|0.1849
91591022|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.27||0.0452||95.0|-1.09|-0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||-0.01|-1.09|0.0452
91709148|NCT03035916|183311329|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91709149|NCT03035916|183311329|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91591023|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.29||0.0359||95.0|-1.18|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.04|-1.18|0.0359
91591024|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.29||0.0184||95.0|-1.26|-0.12||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.12|-1.26|0.0184
91591025|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1043||95.0|-1.06|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.06|0.1043
91591026|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.29||0.1053||95.0|-1.04|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.10|-1.04|0.1053
91591027|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.3||0.144||95.0|-1.03|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.15|-1.03|0.1440
91591028|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.32||0.0866||95.0|-1.17|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.08|-1.17|0.0866
91591029|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.32||0.0359||95.0|-1.3|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||-0.04|-1.30|0.0359
91648294|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0045|TWO_SIDED|95.0|-3.9|-0.7||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-3.9|0.0045
91790197|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||1|TWO_SIDED|95.0|-1.5|1.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.2|-1.5|1.00
91591030|NCT00232141|183072056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.34||0.0711||95.0|-1.3|0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.05|-1.30|0.0711
91591031|NCT00232141|183072058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.23||0.0685||95.0|-0.89|0.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.03|-0.89|0.0685
91591032|NCT00232141|183072058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.928||95.0|-0.52|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.57|-0.52|0.9280
91591033|NCT00232141|183072058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.29||0.6672||95.0|-0.71|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.71|0.6672
91591034|NCT00232141|183072058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.9731||95.0|-0.57|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.57|0.9731
91648295|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0005|TWO_SIDED|95.0|-3.3|-1.0||Female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-3.3|0.0005
91709150|NCT03035916|183311330|OTHER|||||||0.056||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.056
91648296|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.2363|TWO_SIDED|95.0|-4.6|1.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.2|-4.6|0.2363
91591035|NCT00232141|183072058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.9045||95.0|-0.61|0.69||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.69|-0.61|0.9045
91591036|NCT00232141|183072058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.3||0.8298||95.0|-0.53|0.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.66|-0.53|0.8298
91591037|NCT00232141|183072059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.8605||95.0|-0.52|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.44|-0.52|0.8605
91591038|NCT00232141|183072059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8348||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.58|0.8348
91591039|NCT00232141|183072059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.26||0.2227||95.0|-0.83|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.19|-0.83|0.2227
91591040|NCT00232141|183072059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4753||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.34|-0.73|0.4753
91591041|NCT00232141|183072059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.27||0.6017||95.0|-0.4|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.68|-0.40|0.6017
91591042|NCT00232141|183072059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.26||0.6158||95.0|-0.38|0.64||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.64|-0.38|0.6158
91591043|NCT00232141|183072060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.22||0.239||95.0|-0.69|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.17|-0.69|0.2390
91648297|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.0161|TWO_SIDED|95.0|-5.9|-0.6||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-5.9|0.0161
91648298|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0338|TWO_SIDED|95.0|-4.9|-0.2||Postmenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.9|0.0338
91648299|NCT00386100|183189250|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.1|-1.0||Postmenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-4.1|0.0020
91648300|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0005|TWO_SIDED|95.0|-2.3|-0.7||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-2.3|0.0005
91591044|NCT00232141|183072060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.9444||95.0|-0.49|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.45|-0.49|0.9444
91591045|NCT00232141|183072060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.7386||95.0|-0.63|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.63|0.7386
91591046|NCT00232141|183072060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.27||0.3493||95.0|-0.79|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.28|-0.79|0.3493
91591047|NCT00232141|183072060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.3||0.6596||95.0|-0.46|0.73||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.73|-0.46|0.6596
91591048|NCT00232141|183072060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.27||0.4075||95.0|-0.31|0.77||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.77|-0.31|0.4075
91782111|NCT00473382|183443893|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|28.3|||<|0.0001|TWO_SIDED|95.0|20.2|36.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||36.4|20.2|<0.0001
91591049|NCT00232141|183072061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.0202||95.0|-1.01|-0.09||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.09|-1.01|0.0202
91591050|NCT00232141|183072061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8865||95.0|-0.55|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.55|0.8865
91591051|NCT00232141|183072061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9964||95.0|-0.54|0.54||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.54|-0.54|0.9964
91591052|NCT00232141|183072061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5993||95.0|-0.7|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.70|0.5993
91591053|NCT00232141|183072061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.31||0.3553||95.0|-0.33|0.9||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.90|-0.33|0.3553
91591054|NCT00232141|183072061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2771||95.0|-0.25|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.88|-0.25|0.2771
91591055|NCT00232141|183072062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.26||0.2352||95.0|-0.82|0.2||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.20|-0.82|0.2352
91591056|NCT00232141|183072062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7607||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.60|0.7607
91648301|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.011|TWO_SIDED|95.0|-1.7|-0.2||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-1.7|0.0110
91591057|NCT00232141|183072062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.6563||95.0|-0.64|0.4||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.40|-0.64|0.6563
91591058|NCT00232141|183072062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8319||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.47|-0.58|0.8319
91591059|NCT00232141|183072062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3086||95.0|-0.28|0.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.89|-0.28|0.3086
91591060|NCT00232141|183072062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.7972||95.0|-0.48|0.62||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.62|-0.48|0.7972
91591061|NCT00232141|183072063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.1863||95.0|-0.94|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.18|-0.94|0.1863
91591062|NCT00232141|183072063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|-0.31||0.5953||95.0|-0.77|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.77|0.5953
91591063|NCT00232141|183072063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.28||0.508||95.0|-0.73|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.36|-0.73|0.5080
91591064|NCT00232141|183072063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5842||95.0|-0.7|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.39|-0.70|0.5842
91591065|NCT00232141|183072063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.3||0.4286||95.0|-0.35|0.83||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.83|-0.35|0.4286
91591066|NCT00232141|183072063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.28||0.5766||95.0|-0.4|0.71||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.71|-0.40|0.5766
91591067|NCT00232141|183072064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.5493||95.0|-0.73|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.39|-0.73|0.5493
91591068|NCT00232141|183072064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9875||95.0|-0.58|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.59|-0.58|0.9875
91591069|NCT00232141|183072064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.29||0.6931||95.0|-0.68|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.68|0.6931
91591070|NCT00232141|183072064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4614||95.0|-0.34|0.75||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.75|-0.34|0.4614
91591071|NCT00232141|183072064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.31||0.1467||95.0|-0.16|1.06||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.06|-0.16|0.1467
91591072|NCT00232141|183072064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2819||95.0|-0.25|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.25|0.2819
91782112|NCT00473382|183443894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.5|-1.3|<0.0001
91782113|NCT00473382|183443894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.0|-1.6|<0.0001
91591073|NCT00232141|183072065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8727||95.0|-0.55|0.46||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.46|-0.55|0.8727
91591074|NCT00232141|183072065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6897||95.0|-0.65|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.65|0.6897
91591075|NCT00232141|183072065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7527||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.44|-0.60|0.7527
91591076|NCT00232141|183072065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.6394||95.0|-0.67|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.67|0.6394
91591077|NCT00232141|183072065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.31||0.1188||95.0|-0.13|1.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.11|-0.13|0.1188
91591078|NCT00232141|183072065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.28||0.2685||95.0|-0.24|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.24|0.2685
91648302|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0618|TWO_SIDED|95.0|-1.1|0.0||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-1.1|0.0618
91648303|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.011|TWO_SIDED|95.0|-2.3|-0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.3|0.0110
91591079|NCT00232141|183072066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.4991||95.0|-0.74|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.36|-0.74|0.4991
91591080|NCT00232141|183072066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6094||95.0|-0.73|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.73|0.6094
91591081|NCT00232141|183072066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.26||0.3669||95.0|-0.76|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.28|-0.76|0.3669
91591082|NCT00232141|183072066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7641||95.0|-0.43|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.43|0.7641
91709151|NCT03035916|183311330|OTHER|||||||0.009||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.009
91591083|NCT00232141|183072066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9428||95.0|-0.51|0.55||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.55|-0.51|0.9428
91591084|NCT00232141|183072066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.26||0.9508||95.0|-0.52|0.49||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.49|-0.52|0.9508
91591085|NCT00232141|183072067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073||95.0|-1.18|-0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.19|-1.18|0.0073
91591086|NCT00232141|183072067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.3||0.2202||95.0|-0.96|0.22||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.22|-0.96|0.2202
91591087|NCT00232141|183072067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.29||0.1824||95.0|-0.95|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.18|-0.95|0.1824
91648304|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.0272|TWO_SIDED|95.0|-1.9|-0.1||Male population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.9|0.0272
91648305|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0337|TWO_SIDED|95.0|-1.6|-0.1||Male population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.6|0.0337
91648306|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.7||||0.0152|TWO_SIDED|95.0|-3.1|-0.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-3.1|0.0152
91648307|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.4|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-2.4|0.0570
91648308|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.2||||0.0296|TWO_SIDED|95.0|-4.3|-0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.3|0.0296
91782114|NCT01166282|183443924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.17|||=|0.039|TWO_SIDED|95.0|-99.69|-2.66|||ANCOVA|||||-2.66|-99.69|=0.039
91782115|NCT01166282|183443925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.62|||=|0.382|TWO_SIDED|95.0|-5.32|2.08|||1-way ANOVA|||||2.08|-5.32|=0.382
91591088|NCT00232141|183072067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1872||95.0|-0.98|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.19|-0.98|0.1872
91591089|NCT00232141|183072067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.32||0.4374||95.0|-0.38|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.88|-0.38|0.4374
91591090|NCT00232141|183072067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.3||0.4406||95.0|-0.36|0.82||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.82|-0.36|0.4406
91591091|NCT00232141|183072068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.27||0.2277||95.0|-0.86|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.21|-0.86|0.2277
91709152|NCT03035916|183311330|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
91782116|NCT01166282|183443926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|||=|0.209|TWO_SIDED|95.0|-8.78|1.97|||1-way ANOVA|||||1.97|-8.78|=0.209
91782117|NCT01166282|183443927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||=|0.509|TWO_SIDED|95.0|-4.49|2.26|||1-way ANOVA|||||2.26|-4.49|=0.509
91591092|NCT00232141|183072068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8407||95.0|-0.71|0.58||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.58|-0.71|0.8407
91591093|NCT00232141|183072068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8809||95.0|-0.62|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.53|-0.62|0.8809
91591094|NCT00232141|183072068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.29||0.6288||95.0|-0.72|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.43|-0.72|0.6288
91591095|NCT00232141|183072068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9739||95.0|-0.59|0.61||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.61|-0.59|0.9739
91591096|NCT00232141|183072068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8926||95.0|-0.61|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.53|-0.61|0.8926
91591097|NCT00232141|183072071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7136||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.7136
91591098|NCT00232141|183072072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.6729
91591099|NCT05564299|183072076|OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test||||0.053
91648309|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.0155|TWO_SIDED|95.0|-4.4|-0.5||Premenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.5|-4.4|0.0155
91648310|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.587|TWO_SIDED|95.0|-1.7|1.0||Premenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.7|0.5870
91648311|NCT00386100|183189251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.1854|TWO_SIDED|95.0|-3.6|0.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-3.6|0.1854
91709153|NCT03035916|183311330|OTHER|||||||0.198|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.198
91591100|NCT00683163|183072111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.82|TWO_SIDED|95.0|-11.5|9.2|||t-test, 2 sided|||Mean difference in percent change from baseline (Concurrent - Sequential)||9.2|-11.5|0.82
91591101|NCT02229539|183072112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Wilcoxon rank-sum|||||||0.02
91591102|NCT02229539|183072112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon rank-sum|||||||0.004
91591103|NCT00088907|183072126|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Log Rank|||||||0.60
91591104|NCT00088907|183072127|SUPERIORITY_OR_OTHER|||||||0.19|||||||Log Rank|||||||0.19
91591105|NCT01809132|183072177|SUPERIORITY|||||||0.3|||||||Log Rank|||||||.30
91591106|NCT01809132|183072178|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||the observational subject was lost to follow-up||||.42
91591107|NCT01809132|183072179|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
91591108|NCT01809132|183072180|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
91591109|NCT03349775|183072193|SUPERIORITY||Median Difference (Final Values)|-2.57|STANDARD_DEVIATION|5.14||0.35|TWO_SIDED|95.0|-8.32|3.18|||t-test, 2 sided|||||3.18|-8.32|0.35
91591110|NCT03349775|183072194|SUPERIORITY||Median Difference (Final Values)|1.13|STANDARD_DEVIATION|2.13||0.37|TWO_SIDED|95.0|-1.65|3.92|||t-test, 2 sided|||||3.92|-1.65|0.37
91591111|NCT02022085|183072213|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 6 months with Baha Attract vs Unaided||||<0.0001
91591112|NCT02022085|183072213|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 12 months with Baha Attract vs Unaided||||<0.0001
91591113|NCT02022085|183072213|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 24 months with Baha Attract vs Unaided||||<0.0001
91591114|NCT02022085|183072214|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 24 months vs Unaided situation Pre-Op||||<0.0001
91591115|NCT02022085|183072215|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 12 months vs Unaided situation Pre-Op||||<0.0001
91591116|NCT02022085|183072216|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 6 months vs Unaided situation Pre-Op||||<0.0001
91591117|NCT02022085|183072217|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in Noise, 6 months Baha Attract vs Unaided||||<0.0001
91591118|NCT02022085|183072217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 12 months Baha Attract vs Unaided||||<0.0001
91591119|NCT02022085|183072217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 24 months Baha Attract vs Unaided||||<0.0001
91591120|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 50dB||||<0.0001
91591121|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 65dB||||<0.0001
91591122|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 80dB||||<0.0001
91591123|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 50dB||||<0.0001
91591124|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 65dB||||<0.0001
91591125|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 80dB||||<0.0001
91782118|NCT01166282|183443928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||=|0.514|TWO_SIDED|95.0|-18.5|40.5|||Fisher Exact|||||40.5|-18.5|=0.514
91591126|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 50dB||||<0.0001
91591127|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 65dB||||<0.0001
91591128|NCT02022085|183072218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 80dB||||<0.0001
91591129|NCT02022085|183072219|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months with Baha Attract vs Softband: change in PTA4||||0.38
91591130|NCT02022085|183072219|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||12 months with Baha Attract vs Softband: change in PTA4||||0.84
91591131|NCT02022085|183072219|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher's non-parametric permutation test|||24 months with Baha Attract vs Softband: change in PTA4||||0.89
91591132|NCT02022085|183072220|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||250Hz: 6 months with Baha Attract vs Softband||||0.34
91591133|NCT02022085|183072220|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz: 6 months with Baha Attract vs Softband||||0.0004
91591134|NCT02022085|183072220|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz: 6 months with Baha Attract vs Softband||||0.22
91591135|NCT02022085|183072220|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz: 6 months with Baha Attract vs Softband||||0.64
91591136|NCT02022085|183072220|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz: 6 months with Baha Attract vs Softband||||0.039
91591137|NCT02022085|183072220|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz: 6 months with Baha Attract vs Softband||||0.012
91591138|NCT02022085|183072220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz: 6 months with Baha Attract vs Softband||||<0.0001
91591139|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher's non-parametric permutation test|||250Hz: 12 months with Baha Attract vs Softband||||0.11
91591140|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.066|||||||Fisher's non-parametric permutation test|||500Hz: 12 months with Baha Attract vs Softband||||0.066
91591141|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher's non-parametric permutation test|||1000Hz: 12 months with Baha Attract vs Softband||||0.71
91709154|NCT03035916|183311330|OTHER|||||||0.047|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.047
91591142|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher's non-parametric permutation test|||2000Hz: 12 months with Baha Attract vs Softband||||0.78
91591143|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher's non-parametric permutation test|||3000Hz: 12 months with Baha Attract vs Softband||||0.015
91591144|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.035|||||||Fisher's non-parametric permutation test|||4000Hz: 12 months with Baha Attract vs Softband||||0.035
91591145|NCT02022085|183072221|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Fisher's non-parametric permutation test|||6000Hz: 12 months with Baha Attract vs Softband||||0.0013
91591146|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||250Hz: 24 months with Baha Attract vs Softband||||0.0051
91591147|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.26|||||||Fisher's non-parametric permutation test|||500Hz: 24 months with Baha Attract vs Softband||||0.26
91591148|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher's non-parametric permutation test|||1000Hz: 24 months with Baha Attract vs Softband||||0.22
91591149|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher's non-parametric permutation test|||2000Hz: 24 months with Baha Attract vs Softband||||0.57
91591150|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||3000Hz: 24 months with Baha Attract vs Softband||||0.064
91591151|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||4000Hz: 24 months with Baha Attract vs Softband||||0.064
91591152|NCT02022085|183072222|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||6000Hz: 24 months with Baha Attract vs Softband||||0.0051
91591153|NCT02022085|183072223|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in Noise with Baha Attract vs Softband||||0.46
91591154|NCT02022085|183072223|SUPERIORITY_OR_OTHER|||||||0.19|||||||Fisher's non-parametric permutation test|||12 months: Speech in Noise with Baha Attract vs Softband||||0.19
91782119|NCT01166282|183443929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.7|||=|0.111|TWO_SIDED|95.0|-2.0|57.5|||Fisher Exact|||||57.5|-2.0|=0.111
91782120|NCT01166282|183443930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.8|||=|0.031|TWO_SIDED|95.0|8.1|61.6|||Fisher Exact|||||61.6|8.1|=0.031
91591155|NCT02022085|183072223|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher's non-parametric permutation test|||24 months: Speech in Noise with Baha Attract vs Softband||||0.31
91591156|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 50dB||||0.43
91591157|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 65dB||||0.16
91591158|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 80dB||||0.65
91591159|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.93|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 50dB||||0.93
91591160|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.094|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 65dB||||0.094
91591161|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.44|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 80dB||||0.44
91591162|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.021|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 50dB||||0.021
91648312|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.9||||0.0038|TWO_SIDED|95.0|-3.2|-0.6||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-3.2|0.0038
91648313|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0134|TWO_SIDED|95.0|-2.7|-0.3||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.7|0.0134
91591163|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 65dB||||0.024
91591164|NCT02022085|183072224|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 80dB||||0.59
91591165|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Comprehensive health state||||0.088
91591166|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Vision||||0.88
91591167|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Hearing||||0.020
91591168|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Speech||||0.039
91591169|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Ambulation||||0.25
91591170|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Dexterity||||0.38
91591171|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Emotion||||0.43
91591172|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Cognition||||0.85
91591173|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Pain||||0.25
91591174|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Comprehensive health state||||0.088
91591175|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.63|||||||Fisher's non-parametric permutation test|||24 months change in Vision||||0.63
91591176|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Hearing||||0.045
91591177|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher's non-parametric permutation test|||24 months change in Speech||||0.016
91591178|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher's non-parametric permutation test|||24 months change in Ambulation||||0.25
91591179|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxan Signed Rank Test|Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead||24 months change in Dexterity||||0.50
91591180|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher's non-parametric permutation test|||24 months change in Emotion||||0.29
91591181|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.92|||||||Fisher's non-parametric permutation test|||24 months change in Cognition||||0.92
91591182|NCT02022085|183072225|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher's non-parametric permutation test|||24 months change in Pain||||0.020
91591183|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Ease of communication||||<0.0001
91591184|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Background noise||||<0.0001
91591185|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Reverberation||||<0.0001
91591186|NCT02022085|183072226|SUPERIORITY_OR_OTHER|||||||0.69|||||||Fisher's non-parametric permutation test|||6 months: Aversiveness||||0.69
91591187|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Global||||<0.0001
91591188|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Ease of communication||||<0.001
91591189|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Background noise||||<0.001
91591190|NCT02022085|183072226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Reverberation||||<0.001
91591191|NCT02022085|183072226|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||24 months: Aversiveness||||0.84
91591192|NCT02022085|183072226|SUPERIORITY_OR_OTHER||Fisher's non-parametric permutation test||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Global||||<0.001
91591193|NCT02022085|183072227|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 6 months||||<0.0001
91591194|NCT02022085|183072227|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 6 months||||<0.0001
91591195|NCT02022085|183072227|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 6 months||||<0.0001
91591196|NCT02022085|183072227|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 24 months||||<0.0001
91591197|NCT02022085|183072227|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 24 months||||<0.0001
91782121|NCT00531661|183443932|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Negative Binomial Regression|||||||0.0002
91591198|NCT02022085|183072227|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 24 months||||<0.0001
91591199|NCT03383289|183072246|SUPERIORITY||Beta estimate of the percent who fell|0.118|STANDARD_ERROR_OF_MEAN|0.145||0.417|TWO_SIDED||||||Mixed Models Analysis|MIANALYZE was used to model missing data. Models were adjusted for the design effects of clustering.||||||0.4170
91591200|NCT03383289|183072248|OTHER|paired t test|Mean Difference (Final Values)|-1.353|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.708|-0.998|||paired t test|||Analysis of adjusted mean differences using a paired t test procedure||-0.998|-1.708|<0.001
91591201|NCT03383289|183072249|SUPERIORITY||Beta|0.6364|STANDARD_ERROR_OF_MEAN|0.233||0.0064|TWO_SIDED|95.0|0.1797|1.0931|||Poisson regression|||||1.0931|0.1797|0.0064
91648314|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.0967|TWO_SIDED|95.0|-1.5|0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.1|-1.5|0.0967
91782122|NCT00531661|183443933|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
91591202|NCT03383289|183072249|SUPERIORITY||Estimated log mean|-4.0168||||0.001|TWO_SIDED|95.0|-5.5827|-2.4509|||Poisson regression|||||-2.4509|-5.5827|0.001
91591203|NCT03383289|183072250|OTHER|adjusted mean differences from paired t tests|Mean Difference (Final Values)|-0.456|STANDARD_ERROR_OF_MEAN|0.162||0.005|TWO_SIDED|95.0|-0.774|-0.138|||paired t test|||||-0.138|-0.774|0.005
91591204|NCT04439071|183072251|OTHER|||||||0.949|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.949
91591205|NCT04439071|183072270|OTHER|||||||0.033|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.033
91591206|NCT00892177|183072278|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|100.0|||||TWO_SIDED|||||||||||||
91591207|NCT00892177|183072279|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.22|TWO_SIDED|95.0|-0.052|0.262|||Chi-squared, Corrected||Difference in proportion|||0.262|-0.052|0.22
91591208|NCT00892177|183072281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.61|1.4|||Kaplan Meier|||||1.4|0.61|0.7
91591209|NCT00892177|183072282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.14||||0.52|TWO_SIDED|95.0|0.76|1.7|||Kaplan Meier|||||1.7|0.76|0.52
91591210|NCT00892177|183072283|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.96|TWO_SIDED||||||Mixed Models Analysis||The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.|||||0.96
91591211|NCT00892177|183072284|SUPERIORITY|||||||0.6325|||||||Fisher Exact|||||||0.6325
91591212|NCT01011439|183072285|SUPERIORITY||Single proportion|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.59|||Fisher Exact|||H0:p\</=17% vs. H1:p\>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients' enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.||0.59|0.31|<0.001
91591213|NCT01178333|183072305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.98||||0.09|TWO_SIDED|95.0|0.9|4.36|||Regression, Cox|||||4.36|0.90|0.09
91591214|NCT01178333|183072305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.45|TWO_SIDED|95.0|0.65|2.66|||Regression, Cox|||||2.66|0.65|0.45
91591215|NCT01178333|183072307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.76||||0.15|TWO_SIDED|95.0|0.55|40.87|||Regression, Cox|||||40.87|0.55|0.15
91591216|NCT01178333|183072307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35||||0.78|TWO_SIDED|95.0|0.16|11.25|||Regression, Cox|||||11.25|0.16|0.78
91591217|NCT01178333|183072308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.38||||0.06|TWO_SIDED|95.0|0.98|5.79|||Regression, Cox|||||5.79|0.98|0.06
91591218|NCT01178333|183072308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.91||||0.11|TWO_SIDED|95.0|0.87|4.21|||Regression, Cox|||||4.21|0.87|0.11
91591219|NCT01178333|183072309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.8||||0.001|TWO_SIDED|95.0|1.5|5.22|||Regression, Cox|||||5.22|1.50|0.001
91591220|NCT01178333|183072309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.45|||Regression, Cox|||||3.45|1.12|0.02
91591221|NCT01178333|183072312|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.72
91591222|NCT01178333|183072313|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.37
91591223|NCT01178333|183072314|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.02
91591224|NCT01178333|183072315|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
91591225|NCT01178333|183072316|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
91782123|NCT00531661|183443934|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
91591226|NCT01178333|183072317|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
91591227|NCT01178333|183072318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48||||0.003|TWO_SIDED|95.0|1.35|4.55|||Regression, Cox|||||4.55|1.35|0.003
91591228|NCT01178333|183072318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.07|TWO_SIDED|95.0|0.96|2.85|||Regression, Cox|||||2.85|0.96|0.07
91648315|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0512|TWO_SIDED|95.0|-3.0|0.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.0|0.0512
91782124|NCT00531661|183443935|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|||||||0.0077
91782125|NCT00531661|183443936|SUPERIORITY_OR_OTHER|||||||0.0292||95.0|||||Fisher Exact|||||||0.0292
91591229|NCT01178333|183072320|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
91591230|NCT01178333|183072321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.56|1.49|||Regression, Cox|||||1.49|0.56|0.72
91591231|NCT01178333|183072321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.34|TWO_SIDED|95.0|0.54|1.24|||Regression, Cox|||||1.24|0.54|0.34
91591232|NCT01241552|183072328|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.7||||0.3182|TWO_SIDED|95.0|-8.6|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||5.5|-8.6|0.3182
91591233|NCT01241552|183072328|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.1||||0.0003|TWO_SIDED|95.0|-15.9|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-4.3|-15.9|0.0003
91591234|NCT01241552|183072328|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-17.4|-5.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-5.9|-17.4|< 0.0001
91591235|NCT01241552|183072328|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0013|TWO_SIDED|95.0|-16.9|-3.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-3.4|-16.9|0.0013
91591236|NCT01241552|183072328|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.2997|TWO_SIDED|95.0|-6.7|3.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||3.9|-6.7|0.2997
91591237|NCT01241552|183072329|SUPERIORITY_OR_OTHER||Adjusted Difference|-8.3||||0.9775|TWO_SIDED|95.0|-16.3|-0.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||-0.2|-16.3|0.9775
91591238|NCT01241552|183072329|SUPERIORITY_OR_OTHER||Adjusted Difference|4.8||||0.0861|TWO_SIDED|95.0|-2.1|11.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||11.7|-2.1|0.0861
91591239|NCT01241552|183072329|SUPERIORITY_OR_OTHER||Adjusted Difference|3.5||||0.1646|TWO_SIDED|95.0|-3.5|10.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||10.4|-3.5|0.1646
91591240|NCT01241552|183072329|SUPERIORITY_OR_OTHER||Adjusted Difference|11.7||||0.0025|TWO_SIDED|95.0|3.5|19.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||19.7|3.5|0.0025
91709155|NCT03035916|183311330|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.002
91782126|NCT00531661|183443937|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0280
91782127|NCT00531661|183443938|SUPERIORITY_OR_OTHER|||||||0.0236||95.0|||||t-test, 2 sided|||||||0.0236
91782128|NCT00531661|183443939|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Negative Binomial Regression|||||||<0.0001
91591241|NCT01241552|183072329|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.6532|TWO_SIDED|95.0|-8.3|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.5|-8.3|0.6532
91591242|NCT01241552|183072330|SUPERIORITY_OR_OTHER||Adjusted Difference|1.7||||0.6505|TWO_SIDED|95.0|-6.9|10.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||10.7|-6.9|0.6505
91591243|NCT01241552|183072330|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.8||||0.0013|TWO_SIDED|95.0|-17.7|-3.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-3.8|-17.7|0.0013
91591244|NCT01241552|183072330|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.7||||0.0006|TWO_SIDED|95.0|-18.6|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-18.6|0.0006
91591245|NCT01241552|183072330|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7||||0.0007|TWO_SIDED|95.0|-22.5|-5.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-5.2|-22.5|0.0007
91591246|NCT01241552|183072330|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.0||||0.3906|TWO_SIDED|95.0|-7.7|5.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.8|-7.7|0.3906
91591247|NCT01241552|183072331|SUPERIORITY_OR_OTHER||Percentage Difference|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.8|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||12.8|-2.5|0.185
91591248|NCT01241552|183072331|SUPERIORITY_OR_OTHER||Percentage Difference|3.4||||0.323|TWO_SIDED|95.0|-3.3|10.1|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.1|-3.3|0.323
91648316|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.033|TWO_SIDED|95.0|-4.6|-0.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.6|0.0330
91648317|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.0547|TWO_SIDED|95.0|-3.7|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.7|0.0547
91591249|NCT01241552|183072331|SUPERIORITY_OR_OTHER||Percentage Difference|-2.3||||0.507|TWO_SIDED|95.0|-9.1|4.5|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.5|-9.1|0.507
91591250|NCT01241552|183072332|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.246|TWO_SIDED|95.0|-1.5|6.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||6.7|-1.5|0.246
91591251|NCT01241552|183072332|SUPERIORITY_OR_OTHER||Percentage Difference|3.2||||0.069|TWO_SIDED|95.0|-0.3|6.8|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||6.8|-0.3|0.069
91591252|NCT01241552|183072332|SUPERIORITY_OR_OTHER||Percentage Difference|1.2||||0.464|TWO_SIDED|95.0|-2.1|4.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.6|-2.1|0.464
91591253|NCT01241552|183072333|SUPERIORITY_OR_OTHER||Percentage Difference|7.7||||0.027|TWO_SIDED|95.0|0.9|14.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||14.7|0.9|0.027
91591254|NCT01241552|183072333|SUPERIORITY_OR_OTHER||Percentage Difference|1.5||||0.594|TWO_SIDED|95.0|-4.1|7.2|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||7.2|-4.1|0.594
91591255|NCT01241552|183072333|SUPERIORITY_OR_OTHER||Percentage Difference|-5.3||||0.051|TWO_SIDED|95.0|-10.6|0.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||0.0|-10.6|0.051
91591256|NCT01241552|183072334|SUPERIORITY_OR_OTHER||Percentage Difference|1.0||||0.115|TWO_SIDED|95.0|-0.3|3.5|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-0.3|0.115
91591257|NCT01241552|183072334|SUPERIORITY_OR_OTHER||Percentage Difference|0.8||||0.17|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||2.4|-0.5|0.170
91591258|NCT01241552|183072334|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.544|TWO_SIDED|95.0|-0.9|1.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placeb + SOC|||1.6|-0.9|0.544
91591259|NCT01241552|183072335|SUPERIORITY_OR_OTHER||Percentage Difference|0.4||||0.192|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||2.4|-0.5|0.192
91591260|NCT01241552|183072335|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.311|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-0.7|0.311
91591261|NCT01241552|183072335|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.0|-1.0|> 0.999
91591262|NCT01241552|183072336|SUPERIORITY_OR_OTHER||Percentage Difference|3.6|||||TWO_SIDED|95.0|-1.0|8.7|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.7|-1.0|
91591263|NCT01241552|183072336|SUPERIORITY_OR_OTHER||Percentage Difference|4.3|||||TWO_SIDED|95.0|0.2|8.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||8.5|0.2|
91591264|NCT01241552|183072336|SUPERIORITY_OR_OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-2.6|5.2|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||5.2|-2.6|
91591265|NCT01241552|183072337|SUPERIORITY_OR_OTHER||Percentage Difference|-6.9|||||TWO_SIDED|95.0|-16.8|3.5|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-16.8|
91591266|NCT01241552|183072337|SUPERIORITY_OR_OTHER||Percentage Difference|-18.0|||||TWO_SIDED|95.0|-26.3|-9.6|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-9.6|-26.3|
91591267|NCT01241552|183072337|SUPERIORITY_OR_OTHER||Percentage Difference|-16.2|||||TWO_SIDED|95.0|-24.5|-7.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-7.7|-24.5|
91591268|NCT01241552|183072338|SUPERIORITY_OR_OTHER||Percentage Difference|-6.1|||||TWO_SIDED|95.0|-20.1|8.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.6|-20.1|
91591269|NCT01241552|183072338|SUPERIORITY_OR_OTHER||Percentage Difference|-13.2|||||TWO_SIDED|95.0|-25.5|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-25.5|
91591270|NCT01241552|183072338|SUPERIORITY_OR_OTHER||Percentage Difference|-14.4|||||TWO_SIDED|95.0|-26.8|-1.6|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-1.6|-26.8|
91591271|NCT01241552|183072339|SUPERIORITY_OR_OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-16.9|21.0|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||21.0|-16.9|
91591272|NCT01241552|183072339|SUPERIORITY_OR_OTHER||Percentage Difference|-14.6|||||TWO_SIDED|95.0|-28.3|-1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-1.4|-28.3|
91591273|NCT01241552|183072339|SUPERIORITY_OR_OTHER||Percentage Difference|-12.1|||||TWO_SIDED|95.0|-26.2|1.9|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.9|-26.2|
91591274|NCT01241552|183072340|SUPERIORITY_OR_OTHER||Percentage Difference|-10.0|||||TWO_SIDED|95.0|-30.1|10.0|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.0|-30.1|
91648318|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.0613|TWO_SIDED|95.0|-6.3|0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-6.3|0.0613
91591275|NCT01241552|183072340|SUPERIORITY_OR_OTHER||Percentage Difference|-25.3|||||TWO_SIDED|95.0|-43.7|-6.1|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-6.1|-43.7|
91591276|NCT01241552|183072341|SUPERIORITY_OR_OTHER||Percentage Difference|-11.3|||||TWO_SIDED|95.0|-24.9|3.9|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.9|-24.9|
91591277|NCT01241552|183072341|SUPERIORITY_OR_OTHER||Percentage Difference|-12.7|||||TWO_SIDED|95.0|-24.7|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-24.7|
91591278|NCT01241552|183072341|SUPERIORITY_OR_OTHER||Percentage Difference|-16.0|||||TWO_SIDED|95.0|-27.8|-4.0|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.0|-27.8|
91591279|NCT01241552|183072342|SUPERIORITY_OR_OTHER||Percentage Difference|-10.1|||||TWO_SIDED|95.0|-23.2|4.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||4.6|-23.2|
91591280|NCT01241552|183072342|SUPERIORITY_OR_OTHER||Percentage Difference|-11.0|||||TWO_SIDED|95.0|-23.2|1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-23.2|
91591281|NCT01241552|183072342|SUPERIORITY_OR_OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-28.4|-4.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-28.4|
91591282|NCT02606461|183072348|SUPERIORITY||Hazard Ratio (HR)|0.7026||||0.0114|TWO_SIDED|95.0|0.5191|0.9509|||Log Rank|||||0.9509|0.5191|0.0114
91591283|NCT02606461|183072350|SUPERIORITY||Hazard Ratio, log|1.1521||||0.6051|TWO_SIDED|95.0|0.5357|2.4778|||Log Rank|||||2.4778|0.5357|0.6051
91591284|NCT00239226|183072374|SUPERIORITY_OR_OTHER||Slope|3.93||||0.047|||||||Log Rank|||||||0.047
91591285|NCT01892306|183072387|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||.02
91591286|NCT01892306|183072388|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.02
91591287|NCT01892306|183072389|SUPERIORITY_OR_OTHER|||||||0.24|||||||Mixed Models Analysis|||Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.24
91591288|NCT01892306|183072390|OTHER|||||||0.62|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.||||.62
91591289|NCT01892306|183072390|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores||||.03
91591290|NCT01892306|183072391|OTHER|||||||0.95|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.95
91591291|NCT01892306|183072391|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.03
91591292|NCT01892306|183072392|OTHER|||||||0.87|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.87
91591293|NCT01892306|183072392|OTHER|||||||0.37|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.37
91591294|NCT01892306|183072393|OTHER|||||||0.17|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.||||0.17
91591295|NCT01892306|183072393|OTHER|||||||0.04|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores||||.04
91591296|NCT01892306|183072394|OTHER|||||||0.007|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||0.007
91591297|NCT01892306|183072394|OTHER|||||||0.14|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||.14
91591298|NCT01750931|183072419|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.45||||0.4396|TWO_SIDED|95.0|99.4|105.59|||ANOVA|||||105.59|99.40|0.4396
91591299|NCT01750931|183072421|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|105.02||||0.9712|TWO_SIDED|95.0|99.69|110.63|||ANOVA||Comparison of AUC0-t between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||110.63|99.69|0.9712
91591300|NCT01750931|183072421|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.31||||0.9951|TWO_SIDED|95.0|99.05|105.69|||ANOVA||Comparison of AUC0-infinity between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||105.69|99.05|0.9951
91591301|NCT01829425|183072426|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney|Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.|Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds \> - 5% would be consistent with non-inferiority||||5|<.025
91591302|NCT01829425|183072427|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney||||||5|<.025
91591303|NCT01390272|183072555|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-2.1||||0.26|TWO_SIDED|95.0|-5.9|1.6|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||1.6|-5.9|0.26
91591304|NCT01390272|183072556|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.3||||0.5|TWO_SIDED|95.0|-4.9|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-4.9|0.50
91591305|NCT01390272|183072557|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.6||||0.43|TWO_SIDED|95.0|-5.6|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-5.6|0.43
91782129|NCT00531661|183443940|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
91591306|NCT01390272|183072559|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.83|TWO_SIDED|95.0|0.7|1.6|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 6 months||1.6|0.7|0.83
91591307|NCT01390272|183072560|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|0.9||||0.53|TWO_SIDED|95.0|0.5|1.4|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 12 months||1.4|0.5|0.53
91591308|NCT01390272|183072561|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.5||||0.09|TWO_SIDED|95.0|0.9|2.3|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 18 months.||2.3|0.9|0.09
91591309|NCT01390272|183072564|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.7|1.5|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variable of diabetes status and diabetes control.||||1.5|0.7|0.95
91591310|NCT01390272|183072565|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.1|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link.Adjusted for baseline stratification variable of diabetes status and blood pressure control.||Comparison at 12 months||2.1|0.9|0.12
91591311|NCT01390272|183072566|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.2||||0.3|TWO_SIDED|95.0|0.8|1.9|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status and blood pressure control.||Comparison at 18 months||1.9|0.8|0.30
91591312|NCT03044249|183072581|SUPERIORITY||Response Ratio|4.0||||0.48|TWO_SIDED|90.0|-18.0|25.0|||Fisher Exact|||||25|-18|0.48
91591313|NCT03044249|183072583|SUPERIORITY||Mean Difference (Final Values)|-5.28||||0.14|TWO_SIDED|90.0|-11.16|0.61|||Mixed Models Analysis|||||0.61|-11.16|0.14
91591314|NCT03044249|183072584|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.37|TWO_SIDED|90.0|-4.47|1.31|||Mixed Models Analysis|||||1.31|-4.47|0.37
91591315|NCT03044249|183072588|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.94|TWO_SIDED|90.0|-2.0|1.84|||Mixed Models Analysis|||||1.84|-2.00|0.94
91709156|NCT03035916|183311330|OTHER|||||||0.102|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.102
91591316|NCT00782288|183072602|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Measures were compared between Baseline, Treatment \& Recovery periods to determine if changes from baseline differed between placebo and the two digitoxin dose levels. Kruskal-Wallis equity of population rank test was performed on the changes Day 28 minus Day 1. To compare the change from baseline to treatment period between the two arms, a Wilcoxon rank sum test was performed. To determine whether induced sputum Il-8 returned to baseline at the final visit, a one sample sign test was performed.||||>0.05
91790198|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.88|TWO_SIDED|95.0|-3.5|2.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||2.3|-3.5|0.88
91591317|NCT00782288|183072608|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline,Treatment and Recovery periods were compared to determine if changes from baseline differed between placebo and the two digitoxin doses.||||>0.05
91591318|NCT00601250|183072615|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.78|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.5|-0.78|<0.0001
91591319|NCT00601250|183072616|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.431|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.333|||ANCOVA|||Linagliptin vs. Placebo||-0.333|-0.530|<0.0001
91591320|NCT00601250|183072617|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.596|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001||95.0|-0.721|-0.471|||ANCOVA|||Linagliptin vs. Placebo||-0.471|-0.721|<0.0001
91591321|NCT00601250|183072618|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.648|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|-0.785|-0.512|||ANCOVA|||Linagliptin vs. Placebo||-0.512|-0.785|<0.0001
91591322|NCT00601250|183072619|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-21.13|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001||95.0|-27.3|-14.96|||ANCOVA|||Linagliptin vs. Placebo||-14.96|-27.3|<0.0001
91591323|NCT00601250|183072620|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|2.67|<|0.0001||95.0|-21.76|-11.29|||ANCOVA|||Linagliptin vs. Placebo||-11.29|-21.76|<0.0001
91790199|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.98|TWO_SIDED|95.0|-0.8|1.0|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.0|-0.8|0.98
91591324|NCT00601250|183072621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.73|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001||95.0|-22.44|-11.01|||ANCOVA|||Linagliptin vs. Placebo||-11.01|-22.44|<0.0001
91591325|NCT00601250|183072622|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.83|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001||95.0|-26.81|-14.84|||ANCOVA|||Linagliptin vs. Placebo||-14.84|-26.81|<0.0001
91591326|NCT00601250|183072623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.395|||<|0.0001||95.0|2.41|8.013|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||8.013|2.410|<0.0001
91591327|NCT00601250|183072625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.0016||95.0|1.907|15.614|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||15.614|1.907|0.0016
91591328|NCT00601250|183072627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.754|||<|0.0001||95.0|2.486|5.669|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.669|2.486|<0.0001
91591329|NCT00601250|183072628|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-67.13|STANDARD_ERROR_OF_MEAN|13.88|<|0.0001|TWO_SIDED|95.0|-94.69|-39.58|||ANCOVA|||Linagliptin vs. Placebo||-39.58|-94.69|<0.0001
91591330|NCT00601250|183072629|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|10.02|<|0.0001|TWO_SIDED|95.0|-61.71|-21.89|||ANCOVA|||Linagliptin vs. Placebo||-21.89|-61.71|<0.0001
91591331|NCT04050670|183072663|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the thigh versus abdomen injection sites were from 0.80 to 1.25|Ratio of geometric least squares mean|0.953|||||TWO_SIDED|90.0|0.935|0.97|||Linear mixed effects model|||||0.970|0.935|
91591332|NCT04050670|183072663|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.99|||||TWO_SIDED|90.0|0.972|1.01|||Linear mixed effects model|||||1.01|0.972|
91591333|NCT04050670|183072664|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for thigh versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.862|||||TWO_SIDED|90.0|0.818|0.909|||Linear mixed effects model|||||0.909|0.818|
91591334|NCT04050670|183072664|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.921|||||TWO_SIDED|95.0|0.874|0.971|||Linear mixed effects model|||||0.971|0.874|
91591335|NCT04196803|183072694|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||<0.05
91591336|NCT04196803|183072695|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
91591337|NCT04196803|183072696|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
91591338|NCT04196803|183072697|SUPERIORITY||||||=|0.08|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||=0.08
91591339|NCT03523728|183072707|SUPERIORITY||Relative difference|21.32|||=|0.1367|TWO_SIDED|95.0|-5.77|58.22|||linear mixed effect model|||||58.22|-5.77|=0.1367
91591340|NCT03523728|183072707|SUPERIORITY||Relative difference|0.34|||=|0.9812|TWO_SIDED|95.0|-24.57|33.36|||linear mixed effect model|||||33.36|-24.57|=0.9812
91591341|NCT03523728|183072708|SUPERIORITY||Relative difference|101.32|||=|0.0005|TWO_SIDED|95.0|35.63|233.72|||linear mixed effect model|||||233.72|35.63|=0.0005
91591342|NCT03523728|183072708|SUPERIORITY||Relative difference|104.17|||=|0.0002|TWO_SIDED|95.0|39.54|236.45|||linear mixed effect model|||||236.45|39.54|=0.0002
91591343|NCT03523728|183072709|SUPERIORITY||Relative difference|51.01|||=|0.0197|TWO_SIDED|95.0|7.01|125.45|||linear mixed effect model|||||125.45|7.01|=0.0197
91591344|NCT03523728|183072709|SUPERIORITY||Relative difference|46.36|||=|0.0337|TWO_SIDED|95.0|3.21|119.01|||linear mixed effect model|||||119.01|3.21|=0.0337
91591345|NCT03523728|183072711|SUPERIORITY||Least square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.23|=|0.6374|TWO_SIDED|95.0|-0.342|0.556|||Mixed effect model with repeated measure|||||0.556|-0.342|=0.6374
91591346|NCT03523728|183072711|SUPERIORITY||Least square mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.22|=|0.256|TWO_SIDED|95.0|-0.689|0.185|||Mixed effect model with repeated measure|||||0.185|-0.689|=0.2560
91591347|NCT03523728|183072712|SUPERIORITY||Least square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.42|=|0.79|TWO_SIDED|95.0|-0.971|0.747|||Mixed effect model with repeated measure|||||0.747|-0.971|=0.7900
91591348|NCT03523728|183072712|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.32|=|0.6322|TWO_SIDED|95.0|-0.808|0.5|||Mixed effect model with repeated measure|||||0.500|-0.808|=0.6322
91591349|NCT03523728|183072713|SUPERIORITY||Least square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.6245|TWO_SIDED|95.0|-0.506|0.839|||Mixed effect model with repeated measure|||||0.839|-0.506|=0.6245
91591350|NCT03523728|183072713|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.33|=|0.2567|TWO_SIDED|95.0|-1.044|0.281|||Mixed effect model with repeated measure|||||0.281|-1.044|=0.2567
91591351|NCT03523728|183072714|SUPERIORITY||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.68|=|0.2023|TWO_SIDED|95.0|-2.232|0.485|||Mixed effect model with repeated measure|||||0.485|-2.232|=0.2023
91591352|NCT03523728|183072714|SUPERIORITY||Least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.53|=|0.3205|TWO_SIDED|95.0|-1.61|0.537|||Mixed effect model with repeated measure|||||0.537|-1.610|=0.3205
91591353|NCT01509079|183072781|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANOVA|||||||0.38
91591354|NCT01195090|183072789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.165|TWO_SIDED|95.0|-0.58|0.08||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.|ANCOVA|||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.||0.08|-0.58|0.165
91591355|NCT01195090|183072805|NON_INFERIORITY_OR_EQUIVALENCE|Chi-square test|Chi-Square|0.0034||||0.954||||||Chi-square test|Chi-squared|||Chi-square test for percentages of patient achieving an A1C \<7%||||0.954
91591356|NCT05111041|183072818|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.302|3.309||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.309|0.302|1.000
91591357|NCT05111041|183072819|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7389|TWO_SIDED|95.0|0.215|2.972||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||2.972|0.215|0.7389
91591358|NCT05111041|183072821|SUPERIORITY||Odds Ratio (OR)|1.306||||0.6058|TWO_SIDED|95.0|0.474|3.602||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.602|0.474|0.6058
91591359|NCT05111041|183072822|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.349|2.866||||||||2.866|0.349|
91591360|NCT05111041|183072823|SUPERIORITY||Odds Ratio (OR)|1.333||||0.5925|TWO_SIDED|95.0|0.465|3.823||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.823|0.465|0.5925
91591361|NCT01205230|183072829|SUPERIORITY_OR_OTHER||Ratio of least square geometric means|1.66|||||TWO_SIDED|90.0|1.39|1.99|||||Ratio of least square (LS) geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.99|1.39|
91591362|NCT01205230|183072829|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.6|||||TWO_SIDED|90.0|0.52|0.7|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.70|0.52|
91591363|NCT01205230|183072830|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|1.45|||||TWO_SIDED|90.0|1.14|1.86|||||Ratio of LS geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.86|1.14|
91591364|NCT01205230|183072830|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.58|||||TWO_SIDED|90.0|0.5|0.67|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.67|0.50|
91591365|NCT01205230|183072831|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45|||||TWO_SIDED|90.0|-1.06|0.06||||||||0.06|-1.06|
91591366|NCT01205230|183072831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||||TWO_SIDED|90.0|-0.1|2.44||||||||2.44|-0.10|
91591367|NCT00823823|183072856|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.||||1.00
91591368|NCT03334409|183072869|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91591369|NCT03334409|183072870|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
91591370|NCT03334409|183072871|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
91591371|NCT03334409|183072872|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91591372|NCT03334409|183072873|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
91591373|NCT03334409|183072874|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91591374|NCT01495858|183072880|SUPERIORITY_OR_OTHER|||||||0.3047|||||||ANCOVA|||||||0.3047
91591375|NCT01495858|183072881|SUPERIORITY_OR_OTHER|||||||0.1677|||||||Log Rank|||||||0.1677
91591376|NCT01495858|183072882|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
91591377|NCT01495858|183072883|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
91591378|NCT01495858|183072884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91591379|NCT01495858|183072885|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
91591380|NCT01495858|183072886|SUPERIORITY_OR_OTHER|||||||0.0145|||||||Cochran-Mantel-Haenszel|||||||0.0145
91591381|NCT01495858|183072887|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
91591382|NCT01495858|183072888|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Cochran-Mantel-Haenszel|||||||0.0387
91591383|NCT01495858|183072889|SUPERIORITY_OR_OTHER|||||||0.0305|||||||Cochran-Mantel-Haenszel|||||||0.0305
91591384|NCT01495858|183072890|SUPERIORITY_OR_OTHER|||||||0.0176|||||||Cochran-Mantel-Haenszel|||||||0.0176
91591385|NCT01495858|183072891|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91591386|NCT01495858|183072892|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
91591387|NCT01495858|183072893|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91591388|NCT01495858|183072894|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
91591389|NCT01495858|183072895|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
91591390|NCT01495858|183072896|SUPERIORITY_OR_OTHER|||||||0.4519|||||||ANCOVA|||||||0.4519
91591391|NCT01495858|183072897|SUPERIORITY_OR_OTHER|||||||0.3707|||||||ANCOVA|||||||0.3707
91591392|NCT01495858|183072898|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Log Rank|||||||>0.05
91591393|NCT01495858|183072900|SUPERIORITY_OR_OTHER|||||||0.3765|||||||Cochran-Mantel-Haenszel|||||||0.3765
91591394|NCT05215262|183072907|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.04|TWO_SIDED|95.0|0.04|3.17|||Mixed Models Analysis|||||3.17|0.04|0.04
91591395|NCT05215262|183072907|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.82|TWO_SIDED|95.0|-1.59|1.99|||Mixed Models Analysis|||||1.99|-1.59|0.82
91591396|NCT05215262|183072907|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.2|TWO_SIDED|95.0|-0.89|4.23|||Mixed Models Analysis|||Difference-in-differences results, comparing GSES scores between the Intervention and Standard of Care groups at the three-month time point.||4.23|-0.89|0.20
91591397|NCT00718549|183072927|SUPERIORITY|||||||0.028|||||||Log Rank|||||||0.028
91591398|NCT00718549|183072927|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.033||95.0|0.187|0.933|||Cox's proportional hazards regression|||Univariate comparison||0.933|0.187|0.033
91591399|NCT00718549|183072927|SUPERIORITY||Hazard Ratio (HR)|0.052||||0.111|TWO_SIDED|95.0|0.001|1.972|||Cox's proportional hazards model|||Multivariate Comparison||1.972|0.001|0.111
91591400|NCT00718549|183072928|SUPERIORITY||Odds Ratio (OR)|3.654||||0.155|TWO_SIDED|95.0|0.674|28.337|||Regression, Logistic|||Week 129: Univariate Comparison||28.337|0.674|0.155
91591401|NCT00718549|183072929|SUPERIORITY||Odds Ratio (OR)|0.625||||0.634|TWO_SIDED|95.0|0.073|4.114|||Regression, Logistic|||Week 129: Univariate comparison||4.114|0.073|0.634
91591402|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|0.769||||0.752|TWO_SIDED|95.0|0.151|3.92|||Cox's proportional hazards model|||Multivariate Comparison: Age \<60 years versus Age \>/=60 years||3.920|0.151|0.752
91591403|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|0.068||||0.128|TWO_SIDED|95.0|0.002|2.158|||Cox's proportional hazards model|||Multivariate Comparison: Sex: Female versus Male||2.158|0.002|0.128
91591404|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|2.282||||0.728|TWO_SIDED|95.0|0.022|240.864|||Cox's proportional hazards model|||Multivariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||240.864|0.022|0.728
91591405|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|26.275||||0.048|TWO_SIDED|95.0|1.036|666.708|||Cox's proportional hazards model|||Multivariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||666.708|1.036|0.048
91591406|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.417|TWO_SIDED|95.0|0.005|9.1|||Cox's proportional hazards model|||Multivariate Comparison: ZAP-70 Expression Negative versus Positive||9.100|0.005|0.417
91591407|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|0.197||||0.134|TWO_SIDED|95.0|0.024|1.647|||Cox's proportional hazards model|||Multivariate Comparison: CD38 Expression Negative versus Positive||1.647|0.024|0.134
91591408|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|8.373||||0.426|TWO_SIDED|95.0|0.045|1568.717|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 17p No versus Yes||1568.717|0.045|0.426
91591409|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|0.438||||0.733|TWO_SIDED|95.0|0.004|50.334|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 13q No versus Yes||50.334|0.004|0.733
91591410|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|2.621||||0.463|TWO_SIDED|95.0|0.2|34.422|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 11q No versus Yes||34.422|0.200|0.463
91591411|NCT00718549|183072930|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.397|TWO_SIDED|95.0|0.016|5.122|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 12q No versus Yes||5.122|0.016|0.397
91591412|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.982||||0.969|TWO_SIDED|95.0|0.393|2.531|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.531|0.393|0.969
91591413|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.552||||0.26|TWO_SIDED|95.0|0.183|1.488|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||1.488|0.183|0.260
91591414|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.465||||0.121|TWO_SIDED|95.0|0.177|1.242|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||1.242|0.177|0.121
91591415|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.374||||0.045|TWO_SIDED|95.0|0.137|0.957|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||0.957|0.137|0.045
91591416|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|8.809||||0.04|TWO_SIDED|95.0|1.655|163.316|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||163.316|1.655|0.040
91591417|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.921||||0.887|TWO_SIDED|95.0|0.287|2.851|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||2.851|0.287|0.887
91591418|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.932||||0.936|TWO_SIDED|95.0|0.186|6.839|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||6.839|0.186|0.936
91591419|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|1.88||||0.199|TWO_SIDED|95.0|0.719|5.012|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||5.012|0.719|0.199
91591420|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|1.668||||0.375|TWO_SIDED|95.0|0.566|5.649|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.649|0.566|0.375
91591421|NCT00718549|183072931|SUPERIORITY||Odds Ratio (OR)|0.957||||0.961|TWO_SIDED|95.0|0.173|7.275|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||7.275|0.173|0.961
91591422|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|1.31||||0.768|TWO_SIDED|95.0|0.237|10.189|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||10.189|0.237|0.768
91591423|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|0.667||||0.657|TWO_SIDED|95.0|0.086|3.653|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||3.653|0.086|0.657
91591424|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|1.68||||0.655|TWO_SIDED|95.0|0.229|34.486|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||34.486|0.229|0.655
91591425|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|0.635||||0.595|TWO_SIDED|95.0|0.117|3.73|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||3.730|0.117|0.595
91591426|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.164|8.102|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||8.102|0.164|1.000
91591427|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|0.857||||0.882|TWO_SIDED|95.0|0.093|6.636|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||6.636|0.093|0.882
91591428|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|0.154||||0.216|TWO_SIDED|95.0|0.005|4.405|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||4.405|0.005|0.216
91591429|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|0.361||||0.396|TWO_SIDED|95.0|0.017|2.971|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||2.971|0.017|0.396
91591430|NCT00718549|183072932|SUPERIORITY||Odds Ratio (OR)|0.75||||0.776|TWO_SIDED|95.0|0.103|6.572|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||6.572|0.103|0.776
91591431|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|0.528||||0.357|TWO_SIDED|95.0|0.131|2.114|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.114|0.131|0.357
91591432|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|0.694||||0.623|TWO_SIDED|95.0|0.138|2.8|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||2.800|0.138|0.623
91591433|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|4.0||||0.097|TWO_SIDED|95.0|0.901|28.158|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||28.158|0.901|0.097
91591434|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|4.2||||0.233|TWO_SIDED|95.0|0.484|89.588|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||89.588|0.484|0.233
91648319|NCT00386100|183189252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.1369|TWO_SIDED|95.0|-3.9|1.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.7|-3.9|0.1369
91648320|NCT00386100|183189253|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.126|TWO_SIDED|95.0|-1.7|0.2||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-1.7|0.1260
91591435|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|0.844||||0.826|TWO_SIDED|95.0|0.161|3.681|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||3.681|0.161|0.826
91591436|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|1.067||||0.933|TWO_SIDED|95.0|0.246|5.581|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.581|0.246|0.933
91591437|NCT00718549|183072933|SUPERIORITY||Odds Ratio (OR)|0.727||||0.794|TWO_SIDED|95.0|0.08|15.779|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||15.779|0.080|0.794
91591438|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|1.923||||0.591|TWO_SIDED|95.0|0.225|41.751|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||41.751|0.225|0.591
91591439|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|1.3||||0.796|TWO_SIDED|95.0|0.147|9.222|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||9.222|0.147|0.796
91591440|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|3.2||||0.338|TWO_SIDED|95.0|0.375|69.479|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||69.479|0.375|0.338
91591441|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|2.333||||0.486|TWO_SIDED|95.0|0.201|29.008|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||29.008|0.201|0.486
91591442|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|0.667||||0.691|TWO_SIDED|95.0|0.074|4.722|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||4.722|0.074|0.691
91591443|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|1.5||||0.691|TWO_SIDED|95.0|0.212|13.563|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||13.563|0.212|0.691
91591444|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.076|24.621|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||24.621|0.076|1.000
91591445|NCT00718549|183072934|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.099|22.791|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||22.791|0.099|1.000
91591446|NCT05417607|183072956|SUPERIORITY||Mean Difference (Net)|3.75|STANDARD_DEVIATION|5.86||0.0047|TWO_SIDED|95.0|1.27|6.22|||t-test, 2 sided|||Within group pre- and post-intervention.||6.22|1.27|0.0047
91591447|NCT05417607|183072957|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_DEVIATION|7.9||0.2383|TWO_SIDED|95.0|-1.6|6.02|||t-test, 2 sided|||Within group pre- and post-intervention.||6.02|-1.6|0.2383
91591448|NCT05417607|183072958|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_DEVIATION|3.58||0.3426|TWO_SIDED|95.0|-2.22|0.8|||t-test, 2 sided|||Within group pre- and post-intervention.||0.80|-2.22|0.3426
91591449|NCT02871778|183072961|SUPERIORITY||Least Square (LS) Mean difference|1.519||||0.0437|TWO_SIDED|95.0|0.044|2.995|||Mixed-effects Model|||||2.995|0.044|0.0437
91591450|NCT02871778|183072961|SUPERIORITY||LS Mean difference|0.04||||0.9755|TWO_SIDED|95.0|-2.509|2.589|||Mixed-effects Model|||||2.589|-2.509|0.9755
91591451|NCT02871778|183072961|SUPERIORITY||LS Mean difference|2.318||||0.0731|TWO_SIDED|95.0|-0.22|4.856|||Mixed-effects Model|||||4.856|-0.22|0.0731
91591452|NCT02871778|183072961|SUPERIORITY||LS Mean Difference|0.799||||0.5373|TWO_SIDED|95.0|-1.751|3.348|||Mixed-effects Model|||||3.348|-1.751|0.5373
91591453|NCT02871778|183072961|SUPERIORITY||LS Mean difference|0.838||||0.453|TWO_SIDED|95.0|-1.368|3.045|||Mixed-effects Model|||||3.045|-1.368|0.453
91591454|NCT02653300|183072970|OTHER|||||||0.03125|||||||Sign test|||||||0.03125
91591455|NCT00911625|183072981|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|9.502||0.958|TWO_SIDED|95.0|-19.341|18.341|||t-test, 2 sided|||The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level||18.341|-19.341|.958
91591456|NCT00911625|183072982|SUPERIORITY||Odds Ratio (OR)|0.438||||0.0828|TWO_SIDED|95.0|0.172|1.114|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.||1.114|0.172|.0828
91591457|NCT04666350|183072986|OTHER||Combined Difference in Prevalence|-0.025||||0.711|TWO_SIDED|95.0|-0.16|0.109|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.109|-0.160|0.711
91591458|NCT04666350|183072986|OTHER||Combined Difference in Prevalence|-0.016||||0.795|TWO_SIDED|95.0|-0.139|0.107|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.107|-0.139|0.795
91591459|NCT04666350|183072987|OTHER||Relative Rate|0.38||||0.019|TWO_SIDED|95.0|0.21|0.7||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DSFA Day 2 versus Day 1.||0.70|0.21|0.019
91591460|NCT04666350|183072987|OTHER||Relative Rate|0.23||||0.003|TWO_SIDED|95.0|0.11|0.45||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DMFA Day 2 versus Day 1.||0.45|0.11|0.003
91591461|NCT04666350|183072988|OTHER||Combined Difference in Prevalence|-0.023||||0.75|TWO_SIDED|95.0|-0.164|0.118|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.118|-0.164|0.750
91591462|NCT04666350|183072988|OTHER||Combined Difference in Prevalence|-0.031||||0.681|TWO_SIDED|95.0|-0.178|0.117|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.117|-0.178|0.681
91591463|NCT00307333|183072996|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
91709157|NCT03035916|183311330|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.005
91591464|NCT00307333|183072997|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
91591465|NCT00307333|183072998|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
91591466|NCT00307333|183072999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.61|0.99|||||HR = hazard for intervention / hazard for control|||0.99|0.61|
91591467|NCT04166383|183073001|OTHER|||||||0.1||||||P≤0.10 (alpha 0.1); power = 90% (beta 0.1)|Kaplan-Meier|||||||0.10
91591468|NCT03044886|183073006|SUPERIORITY|||||||0.576|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.576
91591469|NCT03044886|183073007|SUPERIORITY|||||||0.489|||||||ANOVA|||||||0.489
91591470|NCT03044886|183073008|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
91591471|NCT03044886|183073008|SUPERIORITY|||||||0.041|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.041
91591472|NCT03044886|183073009|SUPERIORITY|||||||0.71|||||||ANCOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.710
91591473|NCT03044886|183073010|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.340
91591474|NCT03044886|183073011|SUPERIORITY|||||||0.048|||||||ANOVA|||||||0.048
91591475|NCT03044886|183073011|SUPERIORITY|||||||0.038|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.038
91591476|NCT03044886|183073012|SUPERIORITY|||||||0.521|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.521
91591477|NCT03044886|183073013|SUPERIORITY|||||||0.742|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.742
91591478|NCT03044886|183073014|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||<0.05
91591479|NCT03044886|183073014|SUPERIORITY|||||||0.073|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.073
91591480|NCT03044886|183073015|SUPERIORITY|||||||0.348|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.348
91591481|NCT03044886|183073016|SUPERIORITY|||||||0.685|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.685
91591482|NCT03044886|183073017|SUPERIORITY|||||||0.075|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.075
91591483|NCT03044886|183073017|SUPERIORITY|||||||0.083|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.083
91591484|NCT01159912|183073035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146||||0.009|TWO_SIDED|95.0|0.036|0.257|||ANCOVA|||||0.257|0.036|0.009
91591485|NCT01159912|183073035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.145||||0.011|TWO_SIDED|95.0|0.033|0.257|||ANCOVA|||||0.257|0.033|0.011
91591486|NCT00228566|183073079|SUPERIORITY_OR_OTHER||% Responders = 201/241|83.4||||||95.0|78.7|88.1|||Descriptive Statistics||The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.|This was an open label study, with all patients receiving treatment with armodafinil||88.1|78.7|
91591487|NCT01479829|183073080|SUPERIORITY||Chi-square value|5.3466||||0.02|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 5.3466.|The null hypothesis is that there is no difference in the response rate between patients assigned to the intervention cohort or control cohort.||||.02
91591488|NCT01479829|183073081|SUPERIORITY||Chi-square value|13.3821|||<|0.001|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 13.3821.|The null hypothesis is that there is no difference in the remission rate between patients assigned to the intervention cohort or control cohort.||||<.001
91591489|NCT02142738|183073096|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.68||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.68|0.37|<0.001
91591490|NCT02142738|183073097|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.47|0.86||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.86|0.47|0.002
91648321|NCT00386100|183189253|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.3117|TWO_SIDED|95.0|-2.2|0.7||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-2.2|0.3117
91591491|NCT02142738|183073098|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|16.6||||0.0011|TWO_SIDED|95.0|6.0|27.0||One-sided p-value for testing|Miettinen & Nurminem method|Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||H0: difference in %=0 vs. H1: difference in % \>0||27.0|6.0|0.0011
91591492|NCT02615470|183073119|SUPERIORITY||||||=|0.202||||||A priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.202
91591493|NCT02615470|183073120|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
91591494|NCT02615470|183073121|SUPERIORITY||||||=|0.322||||||a priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.322
91591495|NCT01756040|183073146|OTHER|||||||0.932||||||not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||We hypothesized that intestinal permeability as measured by urinary lactulose/rhamnose ratio would be higher in the lower gestational age (\<29 weeks) compared to the more mature infants (≥29 weeks gestation) at postnatal age 7-10 days.||||0.932
91648322|NCT00386100|183189253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1776|TWO_SIDED|95.0|-2.2|0.4||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.4|-2.2|0.1776
91591496|NCT01756040|183073147|OTHER|||||||0.316|||||||t-test, 2 sided|||We hypothesized that stool A1AT would be higher in infants with high IP as measured by urinary La/Rh compared to those with low IP.||||0.316
91591497|NCT01756040|183073148|OTHER|||||||0.011||||||The significance value was estimated using Bayesian goodness-of-fit p-value to assess the significance of the association of the relative abundance of Clostridiales and IP categories. P value \<0.05 was considered significant.|Bayesian goodness of fit|||||||0.011
91591498|NCT01756040|183073149|OTHER|||||||0.0023|||||||t-test, 2 sided|||We hypothesized that infants with normal barrier function (La/Rh ratio ≤0.05) would have been fed breastmilk for longer duration than infants with impaired barrier function (La/Rh\>0.05).||||0.0023
91591499|NCT01756040|183073150|OTHER|||||||1|||||||Chi-squared|||||||1.0
91591500|NCT01756040|183073151|OTHER|||||||0.461||||||A priori threshold \<0.05|Chi-squared|||||||0.461
91591501|NCT01756040|183073152|OTHER|||||||0.019|||||||t-test, 2 sided|||We hypothesized that infants with impaired barrier function as measured by high urinary La/Rh (\>0.05) ratio at 7-10 days of age would require longer time to reach full enteral feedings than infants with normal barrier function (La/Rh≤0.05)||||0.019
91591502|NCT01825057|183073163|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0009|TWO_SIDED|||||adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - Do One|||||0.0009
91591503|NCT01825057|183073163|SUPERIORITY||Median Difference (Final Values)|19.7|||<|0.0001|TWO_SIDED|||||Adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - See One|||||<0.0001
91591504|NCT01825057|183073163|SUPERIORITY||Mean Difference (Final Values)|2.178||||0.4983|TWO_SIDED||||||Kruskal-Wallis|degrees of freedom = 2|mean difference = Do One - See One|||||0.4983
91591505|NCT01825057|183073164|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.0217|TWO_SIDED|||||Adjusted for multiple comparisons using the Dwass, Steel, Critchlow-Fligner Method.|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0217
91591506|NCT01825057|183073164|SUPERIORITY|mean difference is Order One - See One|Mean Difference (Final Values)|1.22||||0.0126|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis|||||||0.0126
91591507|NCT01825057|183073164|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.4231|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference is Do One - See One|||||0.4231
91591508|NCT01825057|183073165|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.0091|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0091
91591509|NCT01825057|183073165|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.0196|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0196
91591510|NCT01825057|183073165|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.2832|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.2832
91591511|NCT01825057|183073166|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.1566|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.1566
91591512|NCT01825057|183073166|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.0982|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0982
91591513|NCT01825057|183073166|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.6631|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.6631
91591514|NCT01825057|183073167|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.1327|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||.1327
91591515|NCT01825057|183073167|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4097|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||||mean difference = Order One - See One|||0.4097
91591516|NCT01825057|183073167|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.8779|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.8779
91591517|NCT01179672|183073187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.03|TWO_SIDED|95.0|-0.82|-0.04|||Mixed Models Analysis|||||-0.04|-0.82|0.030
91591518|NCT01179672|183073188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.008|TWO_SIDED|95.0|-0.95|-0.14||P-value is for mean change from baseline to 12-week endpoint in night pain.|Mixed Models Analysis|||||-0.14|-0.95|0.008
91591519|NCT01179672|183073188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.017|TWO_SIDED|95.0|-1.0|-0.1||P-value is for mean change from baseline to 12 week endpoint in worst pain.|Mixed Models Analysis|||||-0.10|-1.00|0.017
91591520|NCT01179672|183073189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.016|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||||-0.09|-0.90|0.016
91591521|NCT01179672|183073190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.081|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||||0.03|-0.48|0.081
91591522|NCT01179672|183073191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.034|TWO_SIDED|95.0|-0.4|-0.02|||Mixed Models Analysis|||||-0.02|-0.40|0.034
91591523|NCT01179672|183073192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.022|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|ANCOVA adjusted for treatment, pooled investigator and baseline.||||-0.16|-2.07|0.022
91591524|NCT01179672|183073193|SUPERIORITY_OR_OTHER|||||||0.014||||||P-value is for ≥30% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.014
91591525|NCT01179672|183073193|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for ≥50% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.006
91591526|NCT01179672|183073193|SUPERIORITY_OR_OTHER|||||||0.193||||||P-value is for ≥75% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.193
91591527|NCT01179672|183073194|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for ≥30% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.003
91591528|NCT01179672|183073194|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for ≥50% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.001
91591529|NCT01179672|183073194|SUPERIORITY_OR_OTHER|||||||0.168||||||P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel test was stratified by pooled investigator.||||||0.168
91591530|NCT01179672|183073195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24|||Mixed Models Analysis|||||-0.24|-0.96|0.001
91591531|NCT01179672|183073196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.02|TWO_SIDED|95.0|-2.33|-0.2|||Mixed Models Analysis|||||-0.20|-2.33|0.020
91591532|NCT04667377|183073206|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
91709158|NCT03035916|183311330|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
91709159|NCT03035916|183311330|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91591533|NCT04667377|183073206|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Exponential model fit|Model Assumption: 50% of maximum effect achieved at dose 3.6 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
91591534|NCT04667377|183073206|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax1 model fit|Model Assumption: 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
91591535|NCT04667377|183073206|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax2 model fit|Model Assumption: 70% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
91591536|NCT04667377|183073206|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Sigmoid Emax model fit|Model Assumption: 50% of maximum effect achieved at dose 2.4 mg, 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
91648323|NCT00386100|183189253|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.2||||0.2259|TWO_SIDED|95.0|-3.2|0.8||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-3.2|0.2259
91648324|NCT00386100|183189253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.384|TWO_SIDED|95.0|-2.8|1.1||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-2.8|0.3840
91648325|NCT00386100|183189254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.6102|TWO_SIDED|95.0|-1.9|1.1||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-1.9|0.6102
91709160|NCT03035916|183311330|OTHER|||||||0.023|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.023
91709161|NCT03035916|183311330|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91709162|NCT03035916|183311330|OTHER|||||||0.425|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.425
91709163|NCT03035916|183311330|OTHER|||||||0.124|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.124
91591537|NCT04667377|183073206|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.37|STANDARD_ERROR_OF_MEAN|1.5||0.0257|TWO_SIDED|95.0|-6.33|-0.41||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.41|-6.33|0.0257
91591538|NCT04667377|183073206|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-9.69|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-12.57|-6.81||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation as used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-6.81|-12.57|<.0001
91591539|NCT04667377|183073206|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-10.4|STANDARD_ERROR_OF_MEAN|1.48|<|0.0001|TWO_SIDED|95.0|-13.32|-7.49||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.49|-13.32|<.0001
91591540|NCT04667377|183073206|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.12|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-15.0|-9.24||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation will be used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.24|-15.00|<.0001
91591541|NCT04667377|183073207|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.28||||0.0015|TWO_SIDED|95.0|1.57|6.84||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||6.84|1.57|0.0015
91591542|NCT04667377|183073207|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|8.83|||<|0.0001|TWO_SIDED|95.0|4.0|19.46||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||19.46|4.00|<.0001
91591543|NCT04667377|183073207|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|7.48|||<|0.0001|TWO_SIDED|95.0|3.41|16.41||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||16.41|3.41|<.0001
91613925|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.295||||0.0029|TWO_SIDED|95.0|1.092|1.535|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.535|1.092|0.0029
91709164|NCT03035916|183311330|OTHER|||||||0.052|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.052
91782130|NCT00531661|183443941|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
91648326|NCT00386100|183189254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.3445|TWO_SIDED|95.0|-2.9|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-2.9|0.3445
91648327|NCT00386100|183189254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9735|TWO_SIDED|95.0|-2.4|2.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.3|-2.4|0.9735
91648328|NCT00386100|183189254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.4861|TWO_SIDED|95.0|-5.8|2.9||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.9|-5.8|0.4861
91648329|NCT00386100|183189254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.877|TWO_SIDED|95.0|-3.5|4.0||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||4.0|-3.5|0.8770
91648330|NCT00386100|183189255|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.7015|TWO_SIDED|95.0|-1.5|1.0||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.5|0.7015
91648331|NCT00386100|183189255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.6767|TWO_SIDED|95.0|-0.7|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-0.7|0.6767
91648332|NCT00386100|183189255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.4199|TWO_SIDED|95.0|-3.4|1.5||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.5|-3.4|0.4199
91648333|NCT00386100|183189255|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.2526|TWO_SIDED|95.0|-16.4|5.4||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||5.4|-16.4|0.2526
91782131|NCT01262989|183443948|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.95||||||90.0|97.17|109.07|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||109.07|97.17|
91648334|NCT00386100|183189255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.4153|TWO_SIDED|95.0|-1.8|0.8||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-1.8|0.4153
91648335|NCT00386100|183189256|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.168||||0.7895|TWO_SIDED|95.0|-1.066|1.417||Overall population, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.417|-1.066|0.7895
91648336|NCT00386100|183189256|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.745||||0.4155|TWO_SIDED|95.0|-1.064|2.587||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.587|-1.064|0.4155
91648337|NCT00386100|183189256|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.452||||0.6223|TWO_SIDED|95.0|-2.253|1.382||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.382|-2.253|0.6223
91648338|NCT00386100|183189256|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.638||||0.5908|TWO_SIDED|95.0|-3.043|1.826||Premenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.826|-3.043|0.5908
91648339|NCT00386100|183189256|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.155||||0.9154|TWO_SIDED|95.0|-3.037|2.814||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.814|-3.037|0.9154
91648340|NCT00386100|183189257|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.467||||0.8682|TWO_SIDED|95.0|-14.785|20.818||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.818|-14.785|0.8682
91591544|NCT04667377|183073207|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.77|||<|0.0001|TWO_SIDED|95.0|4.77|24.31||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||24.31|4.77|<.0001
91591545|NCT04667377|183073208|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.22||||0.012|TWO_SIDED|95.0|1.29|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|1.29|0.0120
91591546|NCT04667377|183073208|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.62|||<|0.0001|TWO_SIDED|95.0|4.36|25.86||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||25.86|4.36|<.0001
91591547|NCT04667377|183073208|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.78|||<|0.0001|TWO_SIDED|95.0|4.02|23.79||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||23.79|4.02|<.0001
91591548|NCT04667377|183073208|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|5.91|35.55||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||35.55|5.91|<.0001
91591549|NCT04667377|183073209|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|2.13||||0.2654|TWO_SIDED|95.0|0.56|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|0.56|0.2654
91648341|NCT00386100|183189257|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.328||||0.974|TWO_SIDED|95.0|-18.308|23.214||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||23.214|-18.308|0.9740
91648342|NCT00386100|183189257|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.986||||0.8378|TWO_SIDED|95.0|-22.997|37.735||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||37.735|-22.997|0.8378
91648343|NCT00386100|183189257|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.19||||0.7889|TWO_SIDED|95.0|-43.839|108.422||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||108.422|-43.839|0.7889
91648344|NCT00386100|183189257|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.344||||0.88|TWO_SIDED|95.0|-34.853|63.935||Postmenopausal females, Week 80. Log transformed.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||63.935|-34.853|0.8800
91648345|NCT00386100|183189258|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.2168||||0.9069|TWO_SIDED|95.0|-17.6057|24.3392||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||24.3392|-17.6057|0.9069
91648346|NCT00386100|183189258|SUPERIORITY_OR_OTHER||Percent difference from metformin|-10.1648||||0.5118|TWO_SIDED|95.0|-35.6298|25.3742||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.3742|-35.6298|0.5118
91648347|NCT00386100|183189258|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.8777||||0.5816|TWO_SIDED|95.0|-20.2636|48.6692||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||48.6692|-20.2636|0.5816
91648348|NCT00386100|183189258|SUPERIORITY_OR_OTHER||Percent difference from metformin|-1.0031||||0.9587|TWO_SIDED|95.0|-35.928|52.959||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||52.9590|-35.9280|0.9587
91648349|NCT00386100|183189258|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.7614||||0.8337|TWO_SIDED|95.0|-34.4741|67.4901||Postmenopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||67.4901|-34.4741|0.8337
91648350|NCT00386100|183189259|SUPERIORITY_OR_OTHER||Percent difference from metformin|7.527||||0.7041|TWO_SIDED|95.0|-26.773|57.892||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||57.892|-26.773|0.7041
91648351|NCT00386100|183189259|SUPERIORITY_OR_OTHER||Percent difference from metformin|30.211||||0.6403|TWO_SIDED|95.0|-61.586|341.371||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||341.371|-61.586|0.6403
91648352|NCT00386100|183189259|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.929||||0.8474|TWO_SIDED|95.0|-17.015|25.198||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.198|-17.015|0.8474
91521419|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0||||0.604||95.0|-113.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||66|-113|0.604
91648353|NCT00386100|183189260|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.7||||0.486|TWO_SIDED|95.0|-9.6|23.6||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.6|-9.6|0.4860
91648354|NCT00386100|183189260|SUPERIORITY_OR_OTHER||Percent difference from metformin|12.3||||0.3791|TWO_SIDED|95.0|-13.7|46.1||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||46.1|-13.7|0.3791
91648355|NCT00386100|183189260|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.0||||0.7065|TWO_SIDED|95.0|-15.3|27.6||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||27.6|-15.3|0.7065
91648356|NCT00386100|183189260|SUPERIORITY_OR_OTHER||Percent difference from metformin|32.1||||0.1381|TWO_SIDED|95.0|-9.5|92.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||92.7|-9.5|0.1381
91648357|NCT00386100|183189260|SUPERIORITY_OR_OTHER||Percent difference from metformin|-4.3||||0.7195|TWO_SIDED|95.0|-25.4|22.7||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||22.7|-25.4|0.7195
91648358|NCT00386100|183189261|SUPERIORITY_OR_OTHER||Percent difference from metformin|-3.0||||0.5595|TWO_SIDED|95.0|-12.3|7.4||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.4|-12.3|0.5595
91648359|NCT00386100|183189261|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.0||||0.9125|TWO_SIDED|95.0|-15.3|20.4||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.4|-15.3|0.9125
91648360|NCT00386100|183189261|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.8||||0.9122|TWO_SIDED|95.0|-14.0|14.5||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.5|-14.0|0.9122
91648361|NCT00386100|183189261|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.6||||0.7435|TWO_SIDED|95.0|-21.2|38.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||38.7|-21.2|0.7435
91648362|NCT00386100|183189261|SUPERIORITY_OR_OTHER||Percent difference from metformin|-7.5||||0.3897|TWO_SIDED|95.0|-23.0|11.0||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||11.0|-23.0|0.3897
91709165|NCT03035916|183311331|OTHER|||||||0.176||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.176
91709166|NCT03035916|183311331|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
91709167|NCT03035916|183311331|OTHER|||||||0.228|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.228
91782132|NCT01262989|183443949|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.79||||||90.0|96.99|108.93|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||108.93|96.99|
91782133|NCT01262989|183443950|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.47||||||90.0|87.59|101.9|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||101.90|87.59|
91782134|NCT03599089|183443951|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
91782135|NCT03599089|183443952|SUPERIORITY|||||||0.0245|||||||Regression, Logistic|||||||0.0245
91782136|NCT03599089|183443953|SUPERIORITY|||||||0.0019|||||||ANOVA|||||||0.0019
91521420|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.872|TWO_SIDED|95.0|-97.0|82.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||82|-97|0.872
91782137|NCT03511937|183443981|SUPERIORITY||Mean Difference (Final Values)|-31.4||||0.02|TWO_SIDED|95.0|-57.9|-5.0||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-5.0|-57.9|0.02
91591550|NCT04667377|183073209|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.47||||0.0002|TWO_SIDED|95.0|2.89|30.95||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||30.95|2.89|0.0002
91591551|NCT04667377|183073209|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|11.79|||<|0.0001|TWO_SIDED|95.0|3.62|38.36||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||38.36|3.62|<.0001
91591552|NCT04667377|183073209|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|21.02|||<|0.0001|TWO_SIDED|95.0|6.47|68.28||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||68.28|6.47|<.0001
91591553|NCT04667377|183073210|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.53|STANDARD_ERROR_OF_MEAN|1.48||0.0025|TWO_SIDED|95.0|-7.44|-1.61||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-1.61|-7.44|0.0025
91591554|NCT04667377|183073210|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.07|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-14.94|-9.19||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.19|-14.94|<.0001
91591555|NCT04667377|183073210|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.96|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-15.85|-10.07||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-10.07|-15.85|<.0001
91591556|NCT04667377|183073210|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-15.78|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-18.67|-12.9||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-12.90|-18.67|<.0001
91782138|NCT03511937|183443982|SUPERIORITY||Mean Difference (Final Values)|-69.4||||0.55|TWO_SIDED|95.0|-295.5|156.6||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||156.6|-295.5|0.55
91782139|NCT03511937|183443983|SUPERIORITY||Mean Difference (Final Values)|-13.0||||0.006|TWO_SIDED|95.0|-23.0|-4.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||-4|-23|0.006
91782140|NCT03511937|183443984|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.01|TWO_SIDED|95.0|-0.4|-0.1||The a priori threshold for statistical significance was \< 0.05.|Negative binomial regression|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-0.1|-0.4|0.010
91782141|NCT03511937|183443985|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.403|TWO_SIDED|95.0|-0.2|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust standard errors.||||0.5|-0.2|0.403
91521421|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.355|TWO_SIDED|95.0|-48.0|134.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||134|-48|0.355
91648363|NCT00386100|183189262|SUPERIORITY_OR_OTHER||Percent difference from metformin|-2.83||||0.5176|TWO_SIDED|95.0|-10.97|6.06||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||6.06|-10.97|0.5176
91648364|NCT00386100|183189262|SUPERIORITY_OR_OTHER||Percent difference from metformin|-6.26||||0.362|TWO_SIDED|95.0|-18.62|7.97||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.97|-18.62|0.3620
91648365|NCT00386100|183189262|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.72||||0.9115|TWO_SIDED|95.0|-11.39|14.48||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.48|-11.39|0.9115
91648366|NCT00386100|183189262|SUPERIORITY_OR_OTHER||Percent difference from metformin|-13.51||||0.1956|TWO_SIDED|95.0|-30.35|8.31||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||8.31|-30.35|0.1956
91648367|NCT00386100|183189262|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.75||||0.6749|TWO_SIDED|95.0|-13.09|23.85||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.85|-13.09|0.6749
91782142|NCT03511937|183443986|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.005|TWO_SIDED|95.0|0.1|0.8||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.8|0.1|0.005
91648368|NCT02328807|183189263|OTHER||Negative biopsy rate at 6 months after R|0.667|||||TWO_SIDED|95.0|0.223|0.957|||||Two-sided exact confidence interval was calculated using Clopper-Pearson method.|This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.||0.957|0.223|
91648369|NCT03672396|183189268|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.13||||0.378|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.378
91648370|NCT03672396|183189269|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.35||||0.586|TWO_SIDED|95.0|-1.0|1.7|||t-test, 2 sided|||||1.7|-1.0|0.586
91648371|NCT03672396|183189270|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.25||||0.252|TWO_SIDED|95.0|-0.7|0.2|||t-test, 2 sided|||||0.2|-0.7|0.252
91648372|NCT03672396|183189271|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-16.3||||0.111|TWO_SIDED|95.0|-36.9|4.3|||t-test, 2 sided|Mean difference calculated as Post - Pre.||||4.3|-36.9|0.111
91648373|NCT03672396|183189272|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.4||||0.579|TWO_SIDED|95.0|-4.3|7.2|||t-test, 2 sided|||||7.2|-4.3|0.579
91709168|NCT03035916|183311331|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91782143|NCT03511937|183443987|SUPERIORITY||Mean Difference (Final Values)|37.0|||<|0.001|TWO_SIDED|95.0|32.0|43.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||43|32|<0.001
91782144|NCT03511937|183443988|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|1.9||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.9|1.4|<0.001
91782145|NCT03511937|183443989|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.3|<0.001
91782146|NCT03511937|183443990|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.3|0.9|<0.001
91782147|NCT03511937|183443991|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.1|0.7|<0.001
91782148|NCT03511937|183443992|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.055|TWO_SIDED|95.0|-0.001|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.001|0.055
91591557|NCT04667377|183073211|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.36|STANDARD_ERROR_OF_MEAN|1.71||0.0116|TWO_SIDED|95.0|-7.74|-0.98||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.98|-7.74|0.0116
91591558|NCT04667377|183073211|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.03|STANDARD_ERROR_OF_MEAN|1.71|<|0.0001|TWO_SIDED|95.0|-14.39|-7.66||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.66|-14.39|<.0001
91591559|NCT04667377|183073211|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.0|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-14.33|-7.67||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.67|-14.33|<.0001
91591560|NCT04667377|183073211|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.05|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-15.39|-8.71||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-8.71|-15.39|<.0001
91591561|NCT04667377|183073212|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.73|STANDARD_ERROR_OF_MEAN|2.08||0.0733|TWO_SIDED|95.0|-7.82|0.35||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||0.35|-7.82|0.0733
91591562|NCT04667377|183073212|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-5.62|STANDARD_ERROR_OF_MEAN|2.08|<|0.0072|TWO_SIDED|95.0|-9.71|1.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.53|-9.71|<.0072
91591563|NCT04667377|183073212|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.2|STANDARD_ERROR_OF_MEAN|2.05||0.0027|TWO_SIDED|95.0|-10.23|-2.17||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.17|-10.23|0.0027
91591564|NCT04667377|183073212|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.16|STANDARD_ERROR_OF_MEAN|2.08||0.0033|TWO_SIDED|95.0|-10.25|-2.06||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.06|-10.25|0.0033
91591565|NCT04667377|183073213|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-1.44|STANDARD_ERROR_OF_MEAN|1.26||0.2569|TWO_SIDED|95.0|-3.92|1.05||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.05|-3.92|0.2569
91591566|NCT04667377|183073213|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.49|STANDARD_ERROR_OF_MEAN|1.26||0.0495|TWO_SIDED|95.0|-4.97|0.0||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.00|-4.97|0.0495
91648374|NCT03672396|183189273|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.1||||0.948|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.948
91591567|NCT04667377|183073213|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.44|STANDARD_ERROR_OF_MEAN|1.24||0.0506|TWO_SIDED|95.0|-4.9|0.01||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 -placebo.|No formal hypotheses were tested.||0.01|-4.90|0.0506
91782149|NCT03511937|183443993|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.258|TWO_SIDED|95.0|-0.27|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.27|0.258
91782150|NCT03511937|183443994|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.416|TWO_SIDED|95.0|-0.3|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.30|0.416
91591568|NCT04667377|183073213|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.93|STANDARD_ERROR_OF_MEAN|1.25||0.0202|TWO_SIDED|95.0|-5.4|-0.46||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.46|-5.40|0.0202
91591569|NCT03861936|183073217|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on Cochran-Mantel-Haenszel (CMH) model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
91591570|NCT03861936|183073217|SUPERIORITY||Percentage Difference|69.6|||<|0.0001|TWO_SIDED|95.0|55.1|84.0||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||84.0|55.1|<.0001
91591571|NCT03861936|183073223|SUPERIORITY||Percentage Difference|48.4|||<|0.0001|TWO_SIDED|95.0|33.1|63.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||63.7|33.1|<.0001
91591572|NCT03861936|183073223|SUPERIORITY||Percentage Difference|45.7|||<|0.0001|TWO_SIDED|95.0|29.5|61.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||61.8|29.5|<.0001
91591573|NCT03861936|183073224|SUPERIORITY||Percentage Difference|55.2|||<|0.0001|TWO_SIDED|95.0|39.6|70.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.8|39.6|<.0001
91591574|NCT03861936|183073224|SUPERIORITY||Percentage Difference|60.9|||<|0.0001|TWO_SIDED|95.0|45.1|76.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||76.7|45.1|<.0001
91648375|NCT03672396|183189274|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.2||||0.594|TWO_SIDED|95.0|-1.1|0.7|||t-test, 2 sided|||||0.7|-1.1|0.594
91591575|NCT03861936|183073225|SUPERIORITY||Percentage Difference|54.2|||<|0.0001|TWO_SIDED|95.0|37.9|70.5||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.5|37.9|<.0001
91591576|NCT03861936|183073225|SUPERIORITY||Percentage Difference|47.8|||<|0.0001|TWO_SIDED|95.0|30.1|65.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||65.6|30.1|<.0001
91591577|NCT03861936|183073226|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
91591578|NCT03861936|183073226|SUPERIORITY||Percentage Difference|52.2|||<|0.0001|TWO_SIDED|95.0|34.8|69.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||69.6|34.8|<.0001
91591579|NCT03861936|183073227|SUPERIORITY||Least Squares (LS) Mean Difference|-5.82|STANDARD_ERROR_OF_MEAN|0.647|<|0.0001|TWO_SIDED|95.0|-7.1|-4.54||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.54|-7.10|<.0001
91591580|NCT03861936|183073227|SUPERIORITY||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.678|<|0.0001|TWO_SIDED|95.0|-7.15|-4.47||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.47|-7.15|<.0001
91591581|NCT03861936|183073228|SUPERIORITY||LS Mean Difference|-7.63|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001|TWO_SIDED|95.0|-9.12|-6.13||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.13|-9.12|<.0001
91591582|NCT03861936|183073228|SUPERIORITY||LS Mean Difference|-8.26|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|-9.83|-6.69||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.69|-9.83|<.0001
91591583|NCT01312038|183073233|SUPERIORITY_OR_OTHER||||||=|0.93|||||||Paired T-test|df=34||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.||||=0.93
91709169|NCT03035916|183311331|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
91591584|NCT01312038|183073233|SUPERIORITY_OR_OTHER||||||=|0.39|||||||Paired T-test|df = 31||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.||||=0.39
91782151|NCT03511937|183443995|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.609|TWO_SIDED|95.0|-0.14|0.24||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.24|-0.14|0.609
91591585|NCT02665052|183073268|SUPERIORITY|||||||0.64||||||The primary analysis was a two sample t-test (alpha=0.05) of the mean WMFT log-time change at 6 weeks. The threshold for statistical significance was p-value = 0.05.|t-test, 2 sided|||78 participants were needed to generate a sample size of 22 per group and provide 80% power to detect a between group difference in mean Wolf time change (6 week - baseline) based on an a priori assumption of a mean change of 0 and 7.4 seconds respectively for the delayed entry usual care control and home-based BATRAC group; a SD of 7.6 and discontinuation rate of 15%.||||0.64
91782152|NCT03511937|183443996|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.002|TWO_SIDED|95.0|0.1|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.1|0.002
91782153|NCT03511937|183443997|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.8|2.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||2.3|1.8|<0.001
91782154|NCT03511937|183443998|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.311|TWO_SIDED|95.0|-0.23|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.23|0.311
91782155|NCT03511937|183443999|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.253|TWO_SIDED|95.0|-0.3|0.08||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.08|-0.30|0.253
91782156|NCT03511937|183444000|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.658|TWO_SIDED|95.0|-0.22|0.14||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.14|-0.22|0.658
91591586|NCT02665052|183073269|SUPERIORITY|||||||0.01||||||The lab-based group had significant within group mean Fugl-Meyer (FM) change at week 6.|ANOVA|Dunnett's adjustments were used to compare the active intervention changes to the delayed-entry usual care control group.||Within group changes from baseline to week 6 were assessed using analysis of variance.||||0.01
91591587|NCT02665052|183073269|SUPERIORITY|||||||0.97|||||||ANOVA|||FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control.||||0.97
91591588|NCT02665052|183073270|SUPERIORITY|||||||0.31|||||||ANOVA|||Within group SIS hand changes from baseline to week 6 were assessed using analysis of variance followed by comparisons to the delayed-entry usual care control using Dunnett's adjustment.||||0.31
91782157|NCT03511937|183444001|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.661|TWO_SIDED|95.0|-271.3|172.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||172.3|-271.3|0.661
91782158|NCT03511937|183444002|SUPERIORITY||Mean Difference (Final Values)|12.5||||0.082|TWO_SIDED|95.0|-1.6|26.6||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||26.6|-1.6|0.082
91782159|NCT02983552|183444003|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.71|TWO_SIDED|95.0|-2.2|1.7||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 4 week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.||1.7|-2.2|0.71
91613926|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.109|||<|0.0001|TWO_SIDED|95.0|0.05|0.236|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.236|0.050|<0.0001
91648376|NCT03672396|183189275|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.8||||0.274|TWO_SIDED|95.0|-2.3|0.7|||t-test, 2 sided|||||0.7|-2.3|0.274
91782160|NCT02983552|183444005|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|98.3|-2.4|2.1|||||A 2-sided 98.3% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 8-week visit.|||2.1|-2.4|
91782161|NCT02983552|183444011|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|98.3|-13.0|9.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.||9|-13|
91790200|NCT00899353|183459592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.2||0.98|TWO_SIDED|95.0|-6.6|5.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||5.3|-6.6|0.98
91591589|NCT02234284|183073271|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.35|TWO_SIDED|95.0|-0.15|0.43|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.43|-.15|.35
91591590|NCT02234284|183073272|SUPERIORITY||Mean Difference (Net)|0.26||||0.2|TWO_SIDED|95.0|-0.13|0.65|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.65|-.13|.20
91591591|NCT02234284|183073273|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.13|TWO_SIDED|95.0|-0.49|0.07|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.07|-0.49|.13
91591592|NCT02234284|183073274|SUPERIORITY||Mean Difference (Final Values)|8.53||||0.32|TWO_SIDED|95.0|-8.18|25.26|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.|25.26|-8.18|.32
91591593|NCT02234284|183073275|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.27|TWO_SIDED|95.0|-0.23|0.83|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.83|-.23|.27
91591594|NCT02234284|183073276|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.02|TWO_SIDED|95.0|0.07|0.68|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.68|.07|.02
91613927|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0014|TWO_SIDED|95.0|0.159|0.645|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.645|0.159|0.0014
91709170|NCT03035916|183311331|OTHER|||||||0.057|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.057
91782162|NCT02983552|183444012|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|98.3|-15.0|12.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.|For secondary visual acuity outcomes, which included the 8-week treatment group comparison, a Bonferroni adjustment was used to control for multiple testing (3 outcomes tested) to preserve the overall type I error rate at 5% (2-sided alpha=0.017 per test).|12|-15|
91782163|NCT02983552|183444014|SUPERIORITY|||||||0.38||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.38
91782164|NCT02983552|183444016|SUPERIORITY|||||||0.53||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.53
91782165|NCT02983552|183444018|SUPERIORITY|||||||0.19||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.19
91782166|NCT02983552|183444020|SUPERIORITY|||||||0.74||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.74
91591595|NCT02234284|183073277|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.4|TWO_SIDED|95.0|-2.78|1.12|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.12|-2.78|.40
91782167|NCT02983552|183444025|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|99.0|-2.5|0.4|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.4|-2.5|
91591596|NCT02234284|183073278|SUPERIORITY||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-3.0|3.0|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||3|-3|.98
91591597|NCT02234284|183073279|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.3|TWO_SIDED|95.0|-33.3|10.2|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||10.2|-33.3|.30
91591598|NCT02234284|183073280|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.29|TWO_SIDED|95.0|-2.07|0.62|||Mixed Models Analysis||Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|||0.62|-2.07|.29
91591599|NCT02234284|183073281|SUPERIORITY||Mean Difference (Final Values)|39.7|||<|0.001|TWO_SIDED|95.0|19.6|59.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||59.8|19.6|<.001
91591600|NCT02234284|183073282|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.38|TWO_SIDED|95.0|-9.5|25.2|||Mixed Models Analysis||Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.2|-9.5|.38
91591601|NCT02234284|183073283|SUPERIORITY||Median Difference (Final Values)|2.0||||0.73|TWO_SIDED|95.0|-9.4|13.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||13.4|-9.4|.73
91591602|NCT02234284|183073284|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.7|TWO_SIDED|95.0|-14.0|20.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||20.8|-14.0|.70
91613928|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.248||||0.539|TWO_SIDED|95.0|0.616|2.528|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|0.616|0.5390
91790201|NCT01247298|183459600|OTHER||Kaplan Meier Estimate|82.0|||||TWO_SIDED||||||||Kaplan Meier Estimates of Progression Free Survival (PFS)|||||
91648377|NCT03672396|183189276|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.89||||0.013|TWO_SIDED|95.0|0.48|3.29|||t-test, 2 sided|||||3.29|0.48|0.013
91648378|NCT03672396|183189277|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|4.16||||0.369|TWO_SIDED|95.0|-5.54|13.85|||t-test, 2 sided|||||13.85|-5.54|0.369
91648379|NCT03672396|183189278|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.4||||0.945|TWO_SIDED|95.0|-13.5|12.7|||t-test, 2 sided|||||12.7|-13.5|0.945
91648380|NCT03672396|183189279|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.42|TWO_SIDED|95.0|-2.0|4.6|||t-test, 2 sided|||||4.6|-2.0|0.420
91648381|NCT03672396|183189280|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.6||||0.941|TWO_SIDED|95.0|-16.9|15.8|||t-test, 2 sided|||||15.8|-16.9|0.941
91648382|NCT03672396|183189281|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|2.3||||0.203|TWO_SIDED|95.0|-1.4|5.9|||t-test, 2 sided|||||5.9|-1.4|0.203
91648383|NCT03672396|183189282|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.057|TWO_SIDED|95.0|-0.04|2.6|||t-test, 2 sided|||||2.6|-0.04|0.057
91648384|NCT03672396|183189283|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.1||||0.809|TWO_SIDED|95.0|-1.0|1.3|||t-test, 2 sided|||||1.3|-1.0|0.809
91648385|NCT03672396|183189284|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.4||||0.191|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||||1.1|-0.3|0.191
91648386|NCT03672396|183189285|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.5||||0.237|TWO_SIDED|95.0|-0.3|1.3|||t-test, 2 sided|||||1.3|-0.3|0.237
91648387|NCT00065065|183189319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.005||95.0|1.5|10.5|||Regression, Logistic|||||10.5|1.5|.005
91648388|NCT04542330|183189378|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||Acute infection was analysed as recurrent events using an Andersen-Gill Cox proportional hazards regression model with time since inclusion as underlying time scale. The analysis was done for the composite outcome and for all subcomponents separately, presenting Hazard Ratios (HR) with 95% Confidence Intervals (CI) for each. For all recurrent outcomes, a wash-out period of 14 days was used to define new events.||||< 0.05
91648389|NCT04542330|183189379|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for primary outcome.||||< 0.05
91648390|NCT04542330|183189380|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||The secondary outcome, self-reported respiratory symptoms, was analysed the same way as the primary outcome (recurrent events).||||< 0.05
91648391|NCT04542330|183189381|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for the primary outcome.||||< 0.05
91648392|NCT02556632|183189382|OTHER|||||||0.9306|||||||ANOVA|||||||0.9306
91648393|NCT02556632|183189383|OTHER|||||||0.8048|||||||Fisher Exact|||||||0.8048
91648394|NCT02556632|183189384|OTHER|||||||0.8591|||||||ANOVA|||||||0.8591
91648395|NCT04355767|183189417|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.|A Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
91648396|NCT04355767|183189417|SUPERIORITY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-5.9|10.4|||||Risk difference after adjustment for age, sex, symptom duration.|Analysis is of patients with a disease-progression event.||10.4|-5.9|
91648397|NCT04355767|183189418|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event.|A Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
91648398|NCT04355767|183189420|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
91521422|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.839|TWO_SIDED|95.0|-65.0|80.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||80|-65|0.839
91521423|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.0||||0.741|TWO_SIDED|95.0|-60.0|84.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||84|-60|0.741
91521424|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.0||||0.056|TWO_SIDED|95.0|-1.8|143.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||143|-1.8|0.056
91521425|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.0||||0.554|TWO_SIDED|95.0|-107.0|57.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||57|-107|0.554
91521426|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.472|TWO_SIDED|95.0|-110.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||51|-110|0.472
91521427|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.0||||0.116|TWO_SIDED|95.0|-16.0|149.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||149|-16|0.116
91521428|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.805|TWO_SIDED|95.0|-98.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||76|-98|0.805
91521429|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.763|TWO_SIDED|95.0|-73.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||100|-73|0.763
91521430|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.096|TWO_SIDED|95.0|-13.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-13|0.096
91521431|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0||||0.485|TWO_SIDED|95.0|-118.0|56.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||56|-118|0.485
91521432|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.0||||0.704|TWO_SIDED|95.0|-69.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||103|-69|0.704
91521433|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.0||||0.108|TWO_SIDED|95.0|-16.0|159.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||159|-16|0.108
91648399|NCT04355767|183189421|OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||||1.1|-0.4|
91782168|NCT02983552|183444026|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|99.0|-2.3|0.3|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.3|-2.3|
91591603|NCT02234284|183073285|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-5.5|5.3|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||5.3|-5.5|.97
91591604|NCT02234284|183073286|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.52|TWO_SIDED|95.0|-0.32|1.28|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.28|-0.32|.52
91591605|NCT02234284|183073287|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.78|TWO_SIDED|95.0|-0.32|0.22|||Mixed Models Analysis||Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.22|-0.32|.78
91591606|NCT02234284|183073288|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.56|0.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.40|-0.56|.80
91591607|NCT02234284|183073289|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.35|TWO_SIDED|95.0|-0.32|0.06|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.06|-0.32|.35
91591608|NCT02234284|183073290|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.37|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.04|-0.20|.37
91613929|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.604||||0.0223|TWO_SIDED|95.0|1.069|2.405|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.405|1.069|0.0223
91782169|NCT02983552|183444027|SUPERIORITY|||||||0.37|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.||||0.37
91782170|NCT02983552|183444028|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.||||0.99
91782171|NCT02983552|183444029|SUPERIORITY|||||||0.2|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.20
91782172|NCT02983552|183444030|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
91782173|NCT02983552|183444031|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.44
91591609|NCT02234284|183073291|SUPERIORITY||difference in proportion|-18.9||||0.01|TWO_SIDED|95.0|-33.1|-4.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||-4.8|-33.1|.01
91591610|NCT02234284|183073292|SUPERIORITY||Mean Difference (Final Values)|14.6||||0.01|TWO_SIDED|95.0|3.3|25.9|||Mixed Models Analysis||Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.9|3.3|.01
91591611|NCT01338415|183073320|OTHER||Hazard Ratio (HR)|1.438|||||TWO_SIDED|95.0|0.47|4.399|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||4.399|0.470|
91591612|NCT01338415|183073320|OTHER|||||||0.0526||||||p-value \<= 10% indicates that the covariate WHO FC at baseline is related to the time to PAH worsening|Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0526
91591613|NCT01338415|183073320|OTHER||Hazard Ratio (HR)|1.169||||||95.0|0.371|3.681|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||3.681|0.371|
91591614|NCT01338415|183073320|SUPERIORITY|||||||0.076||||||p-value \<= 10% indicates an improvement in model fit|log(e) likelihood ratio|||Test of improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.076
91591615|NCT01338415|183073321|OTHER||Hazard Ratio (HR)|1.935|||||TWO_SIDED|95.0|0.582|6.428|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||6.428|0.582|
91591616|NCT01338415|183073321|OTHER|||||||0.0085|||||||Regression, Cox|p-value \<= 10% indicates that the covariate is related to the time to the time to death up to end-of-study||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0085
91591617|NCT01338415|183073321|OTHER||Hazard Ratio (HR)|1.487|||||TWO_SIDED|95.0|0.437|5.052|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||5.052|0.437|
91782174|NCT02983552|183444032|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
91782175|NCT02983552|183444033|SUPERIORITY|||||||0.12|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.12
91591618|NCT01338415|183073321|SUPERIORITY|||||||0.014|||||||log(e) likelihood ratio|p-value \<= 10% indicates an improvement in model fit||Test of the improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.014
91591619|NCT01576172|183073401|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
91591620|NCT01576172|183073402|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t=-0.39 on 112.7 degrees of freedom (Satterthwaite)||||||0.70
91591621|NCT01576172|183073403|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
91591622|NCT01576172|183073404|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
91591623|NCT01576172|183073405|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
91591624|NCT03496324|183073406|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% confidence interval (CI) (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|94.19|STANDARD_ERROR_OF_MEAN|18.9|||TWO_SIDED|90.0|85.81|103.38||||||||103.38|85.81|
91591625|NCT03496324|183073406|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|111.66|STANDARD_ERROR_OF_MEAN|14.3|||TWO_SIDED|90.0|103.84|120.07||||||||120.07|103.84|
91591626|NCT03496324|183073407|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|101.57|STANDARD_ERROR_OF_MEAN|10.5|||TWO_SIDED|90.0|96.28|107.16||||||||107.16|96.28|
91648400|NCT00301873|183189438|SUPERIORITY_OR_OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.0855||0.2212||95.0||||The p-value is a test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.||||.2212
91782176|NCT02983552|183444034|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
91782177|NCT02983552|183444035|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.12
91591627|NCT03496324|183073407|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|104.47|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|101.4|107.63||||||||107.63|101.4|
91709171|NCT03035916|183311331|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
91782178|NCT02983552|183444036|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
91591628|NCT02092350|183073414|SUPERIORITY_OR_OTHER|||||||0.001|||||||One-sided exact test|||The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be \>45%.||||0.001
91591629|NCT00646906|183073425|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize the effects of aspirin, while reversing the order of administration will not. Percent change from start (8:00 am on day 1) to finish (8:00 am on day 7) of period in serum thromboxane B2 for each order of drug administration will be primary endpoint of interest.||||>0.05
91591630|NCT00646906|183073426|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||||||>0.05
91591631|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative Improvement (%)|8.4|||<|0.001|TWO_SIDED|95.0|7.0|9.7|||a large sample test (z-test)|||Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).||9.7|7.0|<0.001
91591632|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative improvement (%)|8.6|||<|0.001|TWO_SIDED|95.0|7.7|9.6|||a large sample test (z-test)|||Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.||9.6|7.7|<0.001
91591633|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative improvement (%)|79.7|||<|0.001|TWO_SIDED|95.0|70.5|89.0|||a large sample test (z-test)|||Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.||89.0|70.5|<0.001
91591634|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative Improvement (%)|1.0||||0.546|TWO_SIDED|95.0|-2.2|4.2|||a large sample test (z-test)|||Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.||4.2|-2.2|0.546
91591635|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative Improvement (%)|81.9|||<|0.001|TWO_SIDED|95.0|72.2|91.7|||a large sample test (z-test)|||Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).||91.7|72.2|<0.001
91782179|NCT02983552|183444039|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.||||0.07
91782180|NCT02983552|183444040|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.||||0.06
91782181|NCT02983552|183444043|SUPERIORITY||||||>|0.01||||||Statistical significance of the interaction term was based on a 2-sided alpha=0.01.|ANCOVA|||An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.||||>0.01
91591636|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative Improvement (%)|62.1|||<|0.001|TWO_SIDED|95.0|59.1|65.1|||a large sample test (z-test)|||Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.||65.1|59.1|<0.001
91591637|NCT00303979|183073439|SUPERIORITY_OR_OTHER||Relative Improvement (%)|14.7|||<|0.001|TWO_SIDED|95.0|12.6|16.8|||a large sample test (z-test)|||Performance Measure #7: relative change in % of eligible patients with HF education.||16.8|12.6|<0.001
91591638|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.4||||0.004|TWO_SIDED|95.0|-1.1|39.8|||t-test, 2 sided|||Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.||39.8|-1.1|0.004
91591639|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|7.6|||<|0.001|TWO_SIDED|95.0|5.1|10.2|||t-test, 2 sided|||Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.||10.2|5.1|<0.001
91709172|NCT03035916|183311331|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
91709173|NCT03035916|183311331|OTHER|||||||0.004|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.004
91709174|NCT03035916|183311331|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.005
91782182|NCT02023697|183444073|OTHER||Hazard Ratio (HR)|1.057||||0.7047|TWO_SIDED|80.0|0.878|1.272|||Log Rank||Arm B / Arm (A+C)|||1.272|0.878|0.7047
91782183|NCT02023697|183444075|OTHER||Hazard Ratio (HR)|1.26||||0.3134|TWO_SIDED|80.0|0.939|1.69|||Log Rank||Arm C /Arm A|||1.690|0.939|0.3134
91782184|NCT02023697|183444079|OTHER||Hazard Ratio (HR)|1.075||||0.6205|TWO_SIDED|80.0|0.892|1.297|||Log Rank||Arm B/Arm (A+C)|||1.297|0.892|0.6205
91648401|NCT00301873|183189438|SUPERIORITY_OR_OTHER||Slope|0.2357|STANDARD_ERROR_OF_MEAN|0.1091||0.0413||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression||||.0413
91648402|NCT00301873|183189438|SUPERIORITY_OR_OTHER||Slope|-0.232|STANDARD_ERROR_OF_MEAN|0.1029||0.0418||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression||||.0418
91782185|NCT02023697|183444081|OTHER||Hazard Ratio (HR)|0.999||||0.9958|TWO_SIDED|80.0|0.744|1.341|||Log Rank||Arm C/Arm A|||1.341|0.744|0.9958
91782186|NCT02023697|183444085|OTHER||Hazard Ratio (HR)|1.068||||0.7461|TWO_SIDED|80.0|0.823|1.385|||Log Rank||Arm B/Arm (A+C)|||1.385|0.823|0.7461
91782187|NCT02023697|183444087|OTHER||Hazard Ratio (HR)|1.549||||0.155|TWO_SIDED|80.0|1.041|2.306|||Log Rank||Arm C/Arm A|||2.306|1.041|0.1550
91709175|NCT03035916|183311331|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
91709176|NCT03035916|183311331|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
91782188|NCT02023697|183444091|OTHER||Hazard Ratio (HR)|0.969||||0.8284|TWO_SIDED|80.0|0.805|1.167|||Log Rank||Arm B/Arm (A+C)|||1.167|0.805|0.8284
91782189|NCT02023697|183444093|OTHER||Hazard Ratio (HR)|1.059||||0.7896|TWO_SIDED|80.0|0.804|1.396|||Log Rank||Arm C/Arm A|||1.396|0.804|0.7896
91782190|NCT02023697|183444097|OTHER||Hazard Ratio (HR)|0.986||||0.9274|TWO_SIDED|80.0|0.803|1.21|||Log Rank||Arm B/Arm (A+C)|||1.210|0.803|0.9274
91782191|NCT02023697|183444099|OTHER||Hazard Ratio (HR)|1.134||||0.5754|TWO_SIDED|80.0|0.85|1.514|||Log Rank||Arm C/Arm A|||1.514|0.850|0.5754
91782192|NCT02023697|183444105|OTHER||Hazard Ratio (HR)|0.898||||0.6214|TWO_SIDED|80.0|0.678|1.188|||Log Rank||Arm B/Arm (A+C)|||1.188|0.678|0.6214
91782193|NCT02023697|183444107|OTHER||Hazard Ratio (HR)|0.863||||0.7214|TWO_SIDED|80.0|0.505|1.475|||Log Rank||Arm C/Arm A|||1.475|0.505|0.7214
91782194|NCT00541385|183444112|OTHER|"Analysis of the PCR-corrected ACPR response rate on Day 28 for the PA group. Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is ≤90%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is \>90%."|||||<|0.0001||||||The threshold for significance was ≤0.025.|Exact binomial test|||||||<0.0001
91790202|NCT00095147|183459630|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-1.04|||<|0.001|TWO_SIDED|95.0|-1.42|-0.67|||ANCOVA|||The primary analysis was the comparison of abatacept versus placebo for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.67|-1.42|<0.001
91790203|NCT00095147|183459631|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.77|||<|0.001|TWO_SIDED|95.0|-1.14|-0.39|||ANCOVA|||Infliximab versus placebo were compared for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.39|-1.14|<0.001
91648403|NCT00301873|183189438|SUPERIORITY_OR_OTHER||Slope|0.2123|STANDARD_ERROR_OF_MEAN|0.1209||0.1026||95.0||||the p-value is a test of whether the slope ofl the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression||||.1026
91521434|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-64.0||||0.147||95.0|-151.0|23.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||23|-151|0.147
91521435|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.792|TWO_SIDED|95.0|-98.0|75.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||75|-98|0.792
91521436|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.0||||0.275||95.0|-39.0|138.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||138|-39|0.275
91521437|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0||||0.53|TWO_SIDED|95.0|-115.0|59.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||59|-115|0.530
91521438|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.827|TWO_SIDED|95.0|-77.0|96.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||96|-77|0.827
91521439|NCT01218126|182917373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.0||||0.434|TWO_SIDED|95.0|-53.0|124.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||124|-53|0.434
91521440|NCT01218126|182917374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.686|TWO_SIDED|95.0|-3.3|2.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||2.2|-3.3|0.686
91521441|NCT01218126|182917374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.279|TWO_SIDED|95.0|-1.2|4.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||4.2|-1.2|0.279
91521442|NCT01218126|182917374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.193|TWO_SIDED|95.0|-4.6|0.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.9|-4.6|0.193
91521443|NCT01218126|182917374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.803|TWO_SIDED|95.0|-2.7|3.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||3.5|-2.7|0.803
91521444|NCT01218126|182917374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.2|5.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||5.0|-1.2|0.229
91521445|NCT01218126|182917374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.39|TWO_SIDED|95.0|-4.5|1.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.8|-4.5|0.390
91521446|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.157|TWO_SIDED|95.0|0.91|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.01|0.91|0.157
91521447|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||0.95|0.86|0.000
91521448|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.96|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.96|0.86|0.000
91648404|NCT04583592|183189450|SUPERIORITY|||||||0.787||||||\<0.05|Chi-squared|||||||0.787
91648405|NCT02517099|183189466|SUPERIORITY||Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.384||0.05|TWO_SIDED|95.0|1.591|8.8|||Wilcoxon (Mann-Whitney)|||||8.80|1.591|0.05
91709177|NCT03035916|183311331|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
91709178|NCT03035916|183311331|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
91790204|NCT00095147|183459633|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|20.6||||0.001|TWO_SIDED|95.0|7.7|33.6|||Chi-squared, Corrected|||Comparisons were made between ABA and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||33.6|7.7|0.001
91591640|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|30.0|||<|0.001|TWO_SIDED|95.0|24.6|35.5|||t-test, 2 sided|||Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.||35.5|24.6|<0.001
91591641|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|1.0||||0.513||95.0|-3.6|5.5|||t-test, 2 sided|||Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.||5.5|-3.6|0.513
91591642|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|48.4|||<|0.001|TWO_SIDED|95.0|37.9|58.8|||t-test, 2 sided|||Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.||58.8|37.9|<0.001
91591643|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|70.9|||<|0.001|TWO_SIDED|95.0|61.0|80.8|||t-test, 2 sided|||Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.||80.8|61.0|<0.001
91591644|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|50.6|||<|0.001|TWO_SIDED|95.0|27.1|74.2|||t-test, 2 sided|||Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.||74.2|27.1|<0.001
91790205|NCT00095147|183459633|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|17.9||||0.005|TWO_SIDED|95.0|5.1|30.7|||Chi-squared, Corrected|||Comparisons were made between INF and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||30.7|5.1|0.005
91521449|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.072||95.0|0.9|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.00|0.90|0.072
91591645|NCT00303979|183073441|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.2|||<|0.001|TWO_SIDED|95.0|16.3|22.0|||t-test, 2 sided|||Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.||22.0|16.3|<0.001
91591646|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.3||||0.197|TWO_SIDED|95.0|-5.4|25.9|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||25.9|-5.4|0.197
91591647|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6||||0.061|TWO_SIDED|95.0|-0.5|21.7|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||21.7|-0.5|0.061
91591648|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.1||||0.622|TWO_SIDED|95.0|-5.7|3.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||3.4|-5.7|0.622
91591649|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.2||||0.05|TWO_SIDED|95.0|0.0|12.4|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||12.4|0.0|0.05
91591650|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.8||||0.711|TWO_SIDED|95.0|-11.2|7.7|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||7.7|-11.2|0.711
91591651|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.4|||<|0.001|TWO_SIDED|95.0|6.9|22.0|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||22.0|6.9|<0.001
91591652|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|38.5|||<|0.001|TWO_SIDED|95.0|23.2|53.8|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.||53.8|23.2|<0.001
91591653|NCT00303979|183073442|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.6|||<|0.001|TWO_SIDED|95.0|4.2|9.0|||t-test, 2 sided|||Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.||9.0|4.2|<0.001
91591654|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.5||||0.19|TWO_SIDED|95.0|-5.3|26.3|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||26.3|-5.3|0.190
91591655|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.3||||0.048|TWO_SIDED|95.0|0.1|28.4|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||28.4|0.1|0.048
91591656|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|5.8||||0.24|TWO_SIDED|95.0|-3.9|15.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||15.4|-3.9|0.240
91591657|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.7||||0.033|TWO_SIDED|95.0|0.5|13.0|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||13.0|0.5|0.033
91591658|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|9.3||||0.085|TWO_SIDED|95.0|-1.3|19.8|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||19.8|-1.3|0.085
91591659|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|17.6|||<|0.001|TWO_SIDED|95.0|9.3|25.8|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||25.8|9.3|<0.001
91591660|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|59.5|||<|0.001|TWO_SIDED|95.0|33.9|85.2|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.||85.2|33.9|<0.001
91591661|NCT00303979|183073443|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6|||<|0.001|TWO_SIDED|95.0|7.6|13.6|||t-test, 2 sided|||Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.||13.6|7.6|<0.001
91591662|NCT01958788|183073444|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.06|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
91591663|NCT01958788|183073444|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.34|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591664|NCT01958788|183073444|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591665|NCT01958788|183073445|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.32|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
91591666|NCT01958788|183073445|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.29|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591667|NCT01958788|183073445|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.15|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591668|NCT01958788|183073446|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.72|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment follow-up||||
91591669|NCT01958788|183073446|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.66|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591670|NCT01958788|183073446|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.07|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591671|NCT01958788|183073447|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.13|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
91591672|NCT01958788|183073447|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591673|NCT01958788|183073447|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.18|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591674|NCT01958788|183073448|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.41|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
91709179|NCT03035916|183311332|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
91648406|NCT00766506|183189470|SUPERIORITY_OR_OTHER||Least square mean difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.55|-1.91|||ANCOVA|P-value was calculated from analysis of covariance (ANCOVA), with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-1.91|-2.55|<0.001
91790206|NCT00095147|183459635|SUPERIORITY_OR_OTHER||Difference from placebo|-0.38|||<|0.001|TWO_SIDED|95.0|-0.53|-0.23|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.23|-0.53|<0.001
91521450|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0|TWO_SIDED|95.0|0.85|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.95|0.85|0.000
91782195|NCT00541385|183444112|NON_INFERIORITY|The secondary efficacy analysis tested the non-inferiority of PA compared to the AL group with regard to the PCR-corrected ACPR response rate on Day 28 using a 2-sided 95% confidence interval (Newcombe Wilson score method without continuity correction) and a 10% non-inferiority margin for the EE population. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval for the difference in 28-day PCR-corrected ACPR was not lower than 10%.|ACPR percent difference|-1.2||||0.3728|TWO_SIDED|95.0|-3.6|2.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-Square test. If the calculated p-value was \<0.05, then the superiority of PA over AL was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate for the AL group.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate for the AL group."||2.1|-3.6|0.3728
91591675|NCT01958788|183073448|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.65|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591676|NCT01958788|183073448|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.7|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591677|NCT01958788|183073449|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.64|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
91591678|NCT01958788|183073449|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.47|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591679|NCT01958788|183073449|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.56|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591680|NCT01958788|183073450|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
91591681|NCT01958788|183073450|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.15|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
91591682|NCT01958788|183073450|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.55|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
91591683|NCT00240981|183073459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.8||||0.003|TWO_SIDED|95.0|43.9|215.6||The unadjusted analysis using two-sample Student's t-tests of equal change in the trial groups, allowing unequal variance.|t-test, 2 sided|||||215.6|43.9|0.003
91591684|NCT00240981|183073459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.4||||0.004|TWO_SIDED|95.0|43.5|215.4||Adjusted analysis used multiple linear regression, with adjustment for baseline total score on the Short Physical Performance Battery, and self-report of limitations in mobility.|Regression, Linear|||||215.4|43.5|0.004
91521451|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88||||0|TWO_SIDED|95.0|0.83|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 8||0.94|0.83|0.000
91782196|NCT01469377|183444120|SUPERIORITY||Least squares mean difference|-0.9||||0.2404|TWO_SIDED|95.0|-2.4|0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.6|-2.4|0.2404
91591685|NCT00240981|183073460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.2|55.8||Unadjusted|t-test, 2 sided|||||55.8|13.2|0.002
91591686|NCT00240981|183073460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.1|56.2||Adjusted|Regression, Linear|||||56.2|13.1|0.002
91591687|NCT00240981|183073461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7||||0.34|TWO_SIDED|95.0|-9.2|26.7||Unadjusted|t-test, 2 sided|||||26.7|-9.2|0.34
91591688|NCT00240981|183073461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1||||0.37|TWO_SIDED|95.0|-9.9|26.2||Adjusted.|Regression, Linear|||||26.2|-9.9|0.37
91591689|NCT00240981|183073462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.69|TWO_SIDED|95.0|-1.1|1.7||Unadjusted|t-test, 2 sided|||||1.7|-1.1|0.69
91591690|NCT00240981|183073462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26||||0.71|TWO_SIDED|95.0|-1.1|1.7||Adjusted.|Regression, Linear|||||1.7|-1.1|0.71
91591691|NCT00240981|183073463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.26|TWO_SIDED|95.0|-0.035|0.135||Unadjusted.|t-test, 2 sided|||||0.135|-0.035|0.26
91591692|NCT00240981|183073463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.27|TWO_SIDED|95.0|-0.037|0.133||Adjusted|Regression, Linear|||||0.133|-0.037|0.27
91591693|NCT00240981|183073464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.2||||0.05|TWO_SIDED|95.0|0.3|60.1||Unadjusted.|t-test, 2 sided|||||60.1|0.3|0.05
91591694|NCT00240981|183073464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.7||||0.05|TWO_SIDED|95.0|0.2|59.3||Adjusted|Regression, Linear|||||59.3|0.2|0.05
91591695|NCT00240981|183073466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.2|TWO_SIDED|95.0|1.2|2.5||Month 3 Measures|t-test, 2 sided|||||2.5|1.2|0.2
91591696|NCT00240981|183073466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||<|0.0001|TWO_SIDED|95.0|0.4|2.2||Month 6 Measures|t-test, 2 sided|||||2.2|0.4|<.0001
91591697|NCT00240981|183073467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.002|TWO_SIDED|95.0|-2.7|-0.6||3 Months Measures|t-test, 2 sided|||||-0.6|-2.7|0.002
91591698|NCT00240981|183073467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.2||6 Month Measures|t-test, 2 sided|||||-1.2|-2.8|<.0001
91591699|NCT00240981|183073468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074||||0.24|TWO_SIDED|95.0|-0.05|0.19||Unadjusted.|t-test, 2 sided|||||0.19|-0.05|0.24
91591700|NCT00240981|183073468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.14|TWO_SIDED|95.0|-0.03|0.209||Adjusted.|Regression, Linear|||||0.209|-0.030|0.14
91591701|NCT00369785|183073476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in immediate recall memory at 24 weeks||||.62
91591702|NCT00369785|183073477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in discrimination memory between the two groups||||.007
91591703|NCT00800683|183073478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-0.89|-0.31|||ANCOVA|||For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.||-0.31|-0.89|< 0.0001
91591704|NCT00800683|183073479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.03|-0.41|||ANCOVA|||||-0.41|-1.03|< 0.0001
91591705|NCT00800683|183073480|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.9|-0.33|||ANCOVA|||||-0.33|-0.90|< 0.0001
91591706|NCT00800683|183073481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.96|-0.41|||ANCOVA|||||-0.41|-0.96|< 0.0001
91591707|NCT00800683|183073482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.05|-0.39|||ANCOVA|||||-0.39|-1.05|< 0.0001
91591708|NCT00800683|183073483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.06|-0.44|||ANCOVA|||||-0.44|-1.06|< 0.0001
91591709|NCT00800683|183073484|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-0.96|-0.33|||ANCOVA|||||-0.33|-0.96|< 0.0001
91591710|NCT00800683|183073485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-1.02|-0.44|||ANCOVA|||||-0.44|-1.02|< 0.0001
91782197|NCT01469377|183444120|SUPERIORITY||Least squares mean difference|-2.2||||0.0114|TWO_SIDED|95.0|-3.7|-0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||-0.6|-3.7|0.0114
91591711|NCT00800683|183073486|SUPERIORITY_OR_OTHER|||||||0.1199||95.0||||P-value calculated using a Fisher's exact Test.|Fisher Exact|||||||0.1199
91591712|NCT00800683|183073487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.103||||0.2225||95.0|0.003|3.978|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||3.978|0.003|0.2225
91591713|NCT00800683|183073488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.816||||0.8927|TWO_SIDED|95.0|0.042|15.756|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||15.756|0.042|0.8927
91591714|NCT00800683|183073489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|11.43||0.8802||95.0|-24.36|20.91|||ANCOVA|||||20.91|-24.36|0.8802
91591715|NCT00800683|183073490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24|STANDARD_ERROR_OF_MEAN|8.19||0.7848||95.0|-18.47|13.98|||ANCOVA|||||13.98|-18.47|0.7848
91591716|NCT00800683|183073491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|8.09||0.1878||95.0|-26.74|5.31|||ANCOVA|||||5.31|-26.74|0.1878
91591717|NCT00800683|183073492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|7.92||0.5781||95.0|-11.28|20.12|||ANCOVA|||||20.12|-11.28|0.5781
91591718|NCT00800683|183073493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.24|STANDARD_ERROR_OF_MEAN|8.8||0.2954||95.0|-26.67|8.18|||ANCOVA|||||8.18|-26.67|0.2954
91591719|NCT00800683|183073494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.37|STANDARD_ERROR_OF_MEAN|8.27||0.5984||95.0|-12.02|20.75|||ANCOVA|||||20.75|-12.02|0.5984
91591720|NCT00800683|183073495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.07|STANDARD_ERROR_OF_MEAN|8.53||0.4085||95.0|-9.82|23.96|||ANCOVA|||||23.96|-9.82|0.4085
91591721|NCT00800683|183073496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|8.17||0.8698||95.0|-14.84|17.52|||ANCOVA|||||17.52|-14.84|0.8698
91591722|NCT02247960|183073510|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
91591723|NCT00953719|183073521|NON_INFERIORITY_OR_EQUIVALENCE|The prospectively planned primary endpoint analysis was a non-inferiority test of covariate adjusted 24 month or later Harris Hip score means with a 5 point non-inferiority margin. A prospective power analysis with an anticipated Harris Hip score standard deviation of 10.08 (for both treatment groups) indicated that sample sizes of 134 and 67 would provide approximately 95% statistical power for this non-inferiority test with a type 1 error rate of 5%.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|ONE_SIDED|95.0|-1.4||||ANCOVA||||||-1.40|<0.001
91591724|NCT00953719|183073527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.952||95.0|||||Mixed Models Analysis|SAS PROC MIXED was used with an ante-dependence covariance structure.||A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.||||0.952
91648407|NCT00766506|183189471|SUPERIORITY_OR_OTHER|||||||0.219|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 24||||0.219
91709180|NCT03035916|183311332|OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
91591725|NCT01910116|183073539|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Assuming that an improvement in AUSCAN pain score of \>10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.||||0.014
91591726|NCT01910116|183073540|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.011
91591727|NCT01910116|183073541|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
91591728|NCT01910116|183073542|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.014
91591729|NCT01910116|183073543|SUPERIORITY_OR_OTHER|||||||0.728|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.728
91591730|NCT01910116|183073544|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.229
91591731|NCT01910116|183073545|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.194
91591732|NCT01910116|183073546|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.347
91591733|NCT01910116|183073547|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.122
91591734|NCT01910116|183073548|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.097
91591735|NCT01910116|183073550|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.050
91591736|NCT01910116|183073551|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
91591737|NCT01910116|183073552|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
91591738|NCT01910116|183073553|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.049
91591739|NCT01910116|183073554|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.221
91591740|NCT01910116|183073555|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.174
91591741|NCT01910116|183073556|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.124
91591742|NCT01910116|183073557|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
91591743|NCT01910116|183073558|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.126
91591744|NCT01910116|183073559|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
91591745|NCT01910116|183073560|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.660
91591746|NCT01910116|183073561|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
91591747|NCT01910116|183073562|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.186
91591748|NCT01910116|183073563|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.493
91591749|NCT01910116|183073564|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.062
91591750|NCT01910116|183073565|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.604
91591751|NCT01910116|183073566|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.252
91591752|NCT01910116|183073567|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||Chi-squared|||||||0.378
91591753|NCT01910116|183073568|SUPERIORITY_OR_OTHER|||||||0.485|TWO_SIDED||||||Chi-squared|||||||0.485
91591754|NCT01910116|183073569|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
91591755|NCT01910116|183073570|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||Fisher Exact|||||||0.683
91591756|NCT01910116|183073571|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Chi-squared|||||||0.036
91591757|NCT01910116|183073572|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Chi-squared|||||||0.022
91591758|NCT01910116|183073573|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
91591759|NCT01910116|183073574|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.060
91591760|NCT02289352|183073576|EQUIVALENCE|If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, +20%\], then bioequivalence of the Test product to the Reference product is considered to have been demonstrated.|Mean Difference (Net)|-0.58|||||TWO_SIDED|90.0|-6.49|5.33||||||||5.33|-6.49|
91591761|NCT02289352|183073576|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91591762|NCT02289352|183073576|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91591763|NCT02289352|183073577|EQUIVALENCE|"The secondary efficacy variable is the proportion of patients with a clinical response of treatment success on Day 1.~If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both the CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, 20%\], then bioequivalence of the Test to Reference product is considered to have been demonstrated."|Mean Difference (Net)|6.94|||||TWO_SIDED|90.0|-1.54|15.41||||||||15.41|-1.54|
91591764|NCT02289352|183073577|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91591765|NCT02289352|183073577|SUPERIORITY|||||||0.0045|||||||t-test, 2 sided|||||||0.0045
91591766|NCT03606980|183073578|EQUIVALENCE|p\<0.05 was considered statistically significant. A 95% confidence interval was computed using logistic regression model.|Hazard Ratio (HR)|3.11||||0.0366|TWO_SIDED|95.0|1.073|9.005|||Cox proportional hazards analysis|||||9.005|1.073|0.0366
91591767|NCT03606980|183073578|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|4.16||||0.0232|TWO_SIDED|95.0|1.215|14.273|||Cox proportional hazards analysis|||||14.273|1.215|0.0232
91591768|NCT03606980|183073578|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|1.24||||0.64|TWO_SIDED|95.0|0.389|4.615|||Cox proportional hazards analysis|||||4.615|0.389|0.64
91591769|NCT03606980|183073579|EQUIVALENCE|All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.86|||||||ANOVA|||||||0.86
91591770|NCT03606980|183073580|EQUIVALENCE|p\<00.05 was considered statistically significant.||||||0.25|||||||ANOVA|||||||0.25
91591771|NCT03606980|183073581|EQUIVALENCE|p\<0.05 considered statistically significant.||||||0.29|||||||ANOVA|||||||0.29
91591772|NCT03606980|183073582|EQUIVALENCE|All statistical tests were performed using the SAS Studio. All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.57|||||||ANOVA|||||||0.57
91591773|NCT01196533|183073583|SUPERIORITY_OR_OTHER||||||||||||||||||All data in the outcome measure table is presenting the percentage of error.|||
91591774|NCT02374021|183073584|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|95.0|-0.19|0.15|||ANCOVA|||||0.15|-0.19|0.79
91591775|NCT02374021|183073585|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.05|TWO_SIDED|95.0|-0.14|0.17|||ANCOVA|||||0.17|-0.14|0.05
91591776|NCT02374021|183073586|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.05|TWO_SIDED|95.0|-0.11|0.18|||ANCOVA|||||0.18|-0.11|0.05
91591777|NCT02374021|183073587|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.05|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||||0.19|-0.20|0.05
91591778|NCT02374021|183073588|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.05|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|||||0.16|-0.17|0.05
91591779|NCT02807480|183073618|OTHER|Correlation between conflict approach behavior and GAD-7 scores at baseline|Pearson correlation|0.23||||0.088|TWO_SIDED||||||Pearson correlation|||||||.088
91591780|NCT02807480|183073618|OTHER||Pearson correlation|-0.2||||0.134|TWO_SIDED||||||Pearson correlation|||Correlation of baseline response time during conflict with baseline GAD-7 scores.||||.134
91591781|NCT02807480|183073618|OTHER||Pearson correlation|0.12||||0.032|TWO_SIDED||||||Pearson correlation|||Correlation of baseline striatum response to points (reward) with baseline GAD-7 scores.||||.032
91591782|NCT02807480|183073618|OTHER||Pearson correlation|-0.12||||0.375|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right amygdala activity during negative images with baseline GAD7 scores||||0.375
91591783|NCT02807480|183073618|OTHER||Pearson correlation|0.06||||0.651|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right dlPFC activity during conflict decision-making with baseline GAD-7 scores.||||.651
91782198|NCT01469377|183444121|SUPERIORITY||Least squares mean difference|-1.1||||0.2404|TWO_SIDED|95.0|-2.5|0.3||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.3|-2.5|0.2404
91591784|NCT02807480|183073618|OTHER|Correlation of baseline striatum response to negative pictures with baseline GAD-7 scores.|Pearson correlation|-0.35||||0.008|TWO_SIDED||||||Pearson correlation|||||||.008
91591785|NCT02807480|183073619|OTHER||Slope|-1.51||||0.007|TWO_SIDED|95.0|-2.62|-0.41||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear||Those with lower levels of baseline left amygdala response to positive picture outcomes had favorable GAD symptom improvements in BA and limited GAD symptom improvements in EXP.|Assess left amygdala response to positive picture decision outcomes as a predictor of GAD-7 symptom improvement: time x L. Amyg x treatment-arm interaction||-0.41|-2.62|.007
91591786|NCT02807480|183073619|OTHER||Slope|0.36||||0.238|TWO_SIDED|95.0|-0.24|0.97|||Regression, Linear|||Baseline approach behavior during conflict trials predicting trajectory of GAD-7 symptoms: time main effect||0.97|-0.24|0.238
91782199|NCT01469377|183444121|SUPERIORITY||Least squares mean difference|-1.4||||0.114|TWO_SIDED|95.0|-2.8|0.0||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.0|-2.8|0.1140
91591787|NCT02807480|183073619|SUPERIORITY||Slope|-0.49||||0.262|TWO_SIDED|95.0|-1.36|0.37|||Regression, Linear|||Relationship between baseline approach behavior on conflict trials and the trajectory of GAD-7 symptoms: time x treatment interaction effect||0.37|-1.36|.262
91591788|NCT02807480|183073619|OTHER||Slope|2.37||||0.222|TWO_SIDED|95.0|-1.44|6.19|||Regression, Linear|||relationship between baseline response time on conflict trials and trajectory of GAD-7 symptoms: time main effects||6.19|-1.44|.222
91591789|NCT02807480|183073619|SUPERIORITY||Slope|-0.23||||0.942|TWO_SIDED|95.0|-6.48|6.02|||Regression, Linear|||Relationship between baseline average RT during conflict trials on the AAC and trajectory of GAD-7 symptoms: time x treatment interaction effect||6.02|-6.48|.942
91591790|NCT02807480|183073619|OTHER||Slope|-0.05||||0.932|TWO_SIDED|95.0|-1.2|1.1|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time main effects||1.1|-1.2|.932
91591791|NCT02807480|183073619|SUPERIORITY||Slope|-0.08||||0.922|TWO_SIDED|95.0|-1.7|1.53|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time x treatment interaction effects||1.53|-1.7|.922
91591792|NCT02807480|183073619|OTHER||Slope|0.0||||0.998|TWO_SIDED|95.0|-0.99|0.99|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time main effects||.99|-.99|.998
91591793|NCT02807480|183073619|SUPERIORITY||Slope|-0.88||||0.234|TWO_SIDED|95.0|-2.34|0.57|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time x treatment interaction||.57|-2.34|.234
91591794|NCT02807480|183073619|OTHER||Slope|-0.03||||0.967|TWO_SIDED|95.0|-1.53|1.47|||Regression, Linear|||Relationship of right dlPFC activity during conflict decisions with GAD-7 trajectory: time main effects||1.47|-1.53|.967
91591795|NCT02807480|183073619|OTHER||Slope|0.74||||0.504|TWO_SIDED|95.0|-1.43|2.91|||Regression, Linear|||Relationship of right dlPFC activity during conflict decision-making with GAD-7 trajectory: time x treatment interaction effect||2.91|-1.43|0.504
91591796|NCT02807480|183073619|OTHER||Slope|-1.68||||0.612|TWO_SIDED|95.0|-8.21|4.84|||Regression, Linear|||Change in conflict arbitration (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_Change interaction||4.84|-8.21|0.612
91648408|NCT00766506|183189471|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 48||||0.299
91591797|NCT02807480|183073619|SUPERIORITY||Slope|5.08||||0.259|TWO_SIDED|95.0|-3.76|13.92|||Regression, Linear|||change in conflict arbitration response time (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over 10 sessions: RT\_Change x Time x Treatment interaction||13.92|-3.76|.259
91591798|NCT02807480|183073619|OTHER||Slope|-0.53||||0.209|TWO_SIDED|95.0|-1.35|0.3|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.30|-1.35|.209
91591799|NCT02807480|183073619|SUPERIORITY||Slope|1.53||||0.013|TWO_SIDED|95.0|0.33|2.73|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change x Treatment interaction||2.73|0.33|0.013
91591800|NCT02807480|183073620|OTHER||Slope|-2.95||||0.006|TWO_SIDED|95.0|-5.06|-0.84||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of the linear trajectory of symptom change over time: time x EC interaction||-0.84|-5.06|0.006
91591801|NCT02807480|183073620|OTHER||Slope|-1.02||||0.003|TWO_SIDED|95.0|-1.68|-0.36|||Regression, Linear|||Assess avoidance behavior on conflict trials as a predictor of PROMIS Anxiety symptom improvement: time x avoidance interaction||-0.36|-1.68|0.003
91591802|NCT02807480|183073620|OTHER||Slope|-1.88||||0.007|TWO_SIDED|95.0|-2.89|-0.87||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear|||Assess left dlPFC response to baseline negative picture decision outcomes as a predictor of PROMIS Anxiety symptom improvement: time x L. dlPFC interaction||-0.87|-2.89|.007
91591803|NCT02807480|183073620|OTHER||Slope|1.02||||0.003|TWO_SIDED|95.0|0.36|1.68|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms||1.68|0.36|.003
91591804|NCT02807480|183073620|SUPERIORITY||Slope|-0.54||||0.258|TWO_SIDED|95.0|-1.48|0.4|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x approach behavior interaction||0.4|-1.48|.258
91591805|NCT02807480|183073620|OTHER||Slope|1.3||||0.56|TWO_SIDED|95.0|-3.08|5.69|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x approach behavior interaction||5.69|-3.08|.56
91591806|NCT02807480|183073620|SUPERIORITY||Slope|-1.77||||0.629|TWO_SIDED|95.0|-8.95|5.41|||Regression, Linear|||Relationships between baseline average RT (response time) during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x RT interaction||5.41|-8.95|.629
91782200|NCT01526733|183444131|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.15|||<|0.0001|TWO_SIDED|90.0|1.71|2.71||Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||2.71|1.71|<0.0001
91591807|NCT02807480|183073620|OTHER||Slope|-0.21||||0.75|TWO_SIDED|95.0|-1.51|1.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS ANXIETY trajectory: time x striatum interaction effects||1.09|-1.51|0.75
91591808|NCT02807480|183073620|SUPERIORITY||Slope|1.27||||0.169|TWO_SIDED|95.0|-0.54|3.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Anxiety trajectory: time x treatment x striatum interaction effects||3.09|-0.54|.169
91591809|NCT02807480|183073620|OTHER||Slope|0.15||||0.792|TWO_SIDED|95.0|-1.0|1.31|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x amygdala interaction||1.31|-1.00|0.792
91591810|NCT02807480|183073620|SUPERIORITY||Slope|-0.73||||0.396|TWO_SIDED|95.0|-2.41|0.96|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x treatment amygdala interaction||0.96|-2.41|.396
91591811|NCT02807480|183073620|OTHER||Slope|-1.55||||0.009|TWO_SIDED|95.0|-2.7|-0.4|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x dlPFC interaction||-0.4|-2.7|.009
91782201|NCT01526733|183444131|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.62|||<|0.0001|TWO_SIDED|90.0|2.08|3.29||Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||3.29|2.08|<0.0001
91782202|NCT02952820|183444144|SUPERIORITY||least squares geometric mean (LSGM)ratio|0.732|||<|0.0001|TWO_SIDED|95.0|0.636|0.843|||Mixed Models Analysis|||Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value \[MNAR/CCMV\]).||0.843|0.636|<.0001
91782203|NCT02952820|183444144|SUPERIORITY||LSGM ratio|0.701|||<|0.0001|TWO_SIDED|95.0|0.607|0.81|||Mixed Models Analysis|||Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.810|0.607|<.0001
91782204|NCT02952820|183444145|SUPERIORITY||LSGM ratio|0.781|||<|0.0001|TWO_SIDED|95.0|0.725|0.842|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.842|0.725|<.0001
91782205|NCT02952820|183444145|SUPERIORITY||LSGM ratio|0.752|||<|0.0001|TWO_SIDED|95.0|0.698|0.811|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.811|0.698|<.0001
91591812|NCT02807480|183073620|SUPERIORITY||Slope|0.28||||0.724|TWO_SIDED|95.0|-1.28|1.84|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x treatment dlPFC interaction||1.84|-1.28|0.724
91591813|NCT02807480|183073620|OTHER||Slope|-4.99||||0.209|TWO_SIDED|95.0|-12.79|2.8|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||2.80|-12.79|.209
91648409|NCT00766506|183189471|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At study discontinuation or withdrawal||||0.136
91648410|NCT00766506|183189472|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-0.30|-0.74|<0.001
91591814|NCT02807480|183073620|SUPERIORITY||Slope|12.68||||0.017|TWO_SIDED|95.0|2.23|23.13|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||23.13|2.23|0.017
91591815|NCT02807480|183073620|OTHER||Slope|-0.58||||0.259|TWO_SIDED|95.0|-1.59|0.43|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.43|-1.59|.259
91591816|NCT02807480|183073620|OTHER||Slope|1.07||||0.15|TWO_SIDED|95.0|-0.39|2.54|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.54|-0.39|.150
91709181|NCT03035916|183311332|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
91591817|NCT02807480|183073621|OTHER||Slope|-3.52||||0.001|TWO_SIDED|95.0|-5.57|-1.47||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Assess emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of PROMIS Depression scores. Time x EC interaction.||-1.47|-5.57|0.001
91591818|NCT02807480|183073621|OTHER||Slope|-1.93|||<|0.001|TWO_SIDED|95.0|-2.91|-0.95||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline left dlPFC response to negative pictures as a predictor of PROMIS depression symptom improvement: time x L. dlFPC interaction.||-0.95|-2.91|<.001
91591819|NCT02807480|183073621|OTHER||Slope|-2.02||||0.036|TWO_SIDED|95.0|-3.9|-0.13||Threshold for statistical significance is 0.05.|Regression, Linear|||Baseline striatum response to monetary outcomes as a predictor of improvement in depressive symptoms: time x treatment x striatum interaction.||-0.13|-3.9|.036
91591820|NCT02807480|183073621|OTHER||Slope|-1.21|||<|0.001|TWO_SIDED|95.0|-1.85|-0.58||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x approach behavior interaction||-0.58|-1.85|<.001
91591821|NCT02807480|183073621|SUPERIORITY||Slope|-0.91||||0.049|TWO_SIDED|95.0|-1.81|0.0|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x approach behavior interaction||0.00|-1.81|.049
91591822|NCT02807480|183073621|OTHER||Slope|0.6||||0.778|TWO_SIDED|95.0|-3.6|4.81|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x RT interaction||4.81|-3.6|.778
91591823|NCT02807480|183073621|SUPERIORITY||Slope|1.38||||0.696|TWO_SIDED|95.0|-5.56|8.31|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x RT interaction||8.31|-5.56|.696
91591824|NCT02807480|183073621|OTHER||Slope|0.44||||0.503|TWO_SIDED|95.0|-0.84|1.71|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Depression trajectory: time x striatum interaction effects||1.71|-0.84|.503
91591825|NCT02807480|183073621|OTHER||Slope|-0.9||||0.114|TWO_SIDED|95.0|-2.02|0.22|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x amygdala interaction||.22|-2.02|.114
91591826|NCT02807480|183073621|SUPERIORITY||Slope|0.48||||0.561|TWO_SIDED|95.0|-1.15|2.11|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x treatment amygdala interaction||2.11|-1.15|.561
91591827|NCT02807480|183073621|OTHER||Slope|-1.54||||0.007|TWO_SIDED|95.0|-2.66|-0.42|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x dlPFC interaction||-0.42|-2.66|.007
91591828|NCT02807480|183073621|SUPERIORITY||Slope|0.65||||0.403|TWO_SIDED|95.0|-0.87|2.17|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x treatment dlPFC interaction||2.17|-0.87|0.403
91591829|NCT02807480|183073621|OTHER||Slope|-1.51||||0.681|TWO_SIDED|95.0|-8.76|5.73|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||5.73|-8.76|0.681
91591830|NCT02807480|183073621|SUPERIORITY||Slope|5.61||||0.264|TWO_SIDED|95.0|-4.24|15.46|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.46|-4.24|.264
91591831|NCT02807480|183073621|OTHER||Slope|-0.43||||0.367|TWO_SIDED|95.0|-1.38|0.51|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.51|-1.38|.367
91591832|NCT02807480|183073621|OTHER||Slope|0.88||||0.211|TWO_SIDED|95.0|-0.5|2.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.25|-0.50|.211
91591833|NCT02807480|183073622|OTHER||Slope|0.74||||0.028|TWO_SIDED|95.0|0.08|1.41|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS score: time x approach behavior interaction||1.41|0.08|0.028
91591834|NCT02807480|183073622|SUPERIORITY||Slope|-0.55||||0.251|TWO_SIDED|95.0|-1.49|0.39|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x approach behavior interaction||0.39|-1.49|0.251
91591835|NCT02807480|183073622|OTHER||Slope|-0.26||||0.902|TWO_SIDED|95.0|-4.49|3.96|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x RT interaction||3.96|-4.49|0.902
91591836|NCT02807480|183073622|SUPERIORITY||Slope|2.23||||0.519|TWO_SIDED|95.0|-4.55|9.01|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x RT interaction||9.01|-4.55|.519
91591837|NCT02807480|183073622|OTHER||Slope|-0.64||||0.326|TWO_SIDED|95.0|-1.92|0.64|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x striatum interaction effects||0.64|-1.92|.326
91591838|NCT02807480|183073622|SUPERIORITY||Slope|1.26||||0.168|TWO_SIDED|95.0|-0.53|3.05|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x treatment x striatum interaction effects||3.05|-0.53|.168
91709182|NCT03035916|183311333|OTHER|||||||0.644|||||||t-test, 2 sided|||||||0.644
91709183|NCT03035916|183311333|OTHER|||||||0.045|||||||t-test, 2 sided|||||||0.045
91591839|NCT02807480|183073622|OTHER||Slope|-0.5||||0.248|TWO_SIDED|95.0|-1.34|0.35|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x amygdala interaction||0.35|-1.34|.248
91591840|NCT02807480|183073622|SUPERIORITY||Slope|0.3||||0.603|TWO_SIDED|95.0|-0.84|1.44|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x treatment amygdala interaction||1.44|-0.84|0.603
91591841|NCT02807480|183073622|OTHER||Slope|-0.85||||0.107|TWO_SIDED|95.0|-1.89|0.18|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x dlPFC interaction||0.18|-1.89|.107
91591842|NCT02807480|183073622|SUPERIORITY||Slope|0.16||||0.846|TWO_SIDED|95.0|-1.47|1.8|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x treatment x dlPFC interaction||1.80|-1.47|0.846
91591843|NCT02807480|183073622|OTHER||Slope|-2.26||||0.561|TWO_SIDED|95.0|-9.89|5.37|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x RT\_change interaction||5.37|-9.89|.561
91591844|NCT02807480|183073622|SUPERIORITY||Slope|5.45||||0.297|TWO_SIDED|95.0|-4.8|15.7|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.70|-4.80|.297
91591845|NCT02807480|183073622|OTHER||Slope|-0.18||||0.712|TWO_SIDED|95.0|-1.15|0.79|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS cores over the 10 sessions: Time x Behavior\_change interaction||0.79|-1.15|.712
91709184|NCT03035916|183311333|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
91709185|NCT03035916|183311334|OTHER|||||||0.421|||||||t-test, 2 sided|||||||0.421
91782206|NCT02952820|183444145|SUPERIORITY||LSGM ratio|0.81|||<|0.0001|TWO_SIDED|95.0|0.735|0.893|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.893|0.735|<.0001
91782207|NCT02952820|183444145|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.698|0.848|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.848|0.698|<.0001
91782208|NCT02952820|183444145|SUPERIORITY||LSGM ratio|0.778|||<|0.0001|TWO_SIDED|95.0|0.69|0.878|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.878|0.690|<.0001
91782209|NCT02952820|183444145|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.681|0.869|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.869|0.681|<.0001
91782210|NCT02952820|183444146|SUPERIORITY||LSM Difference|4.299|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|2.638|5.961|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.961|2.638|<.0001
91782211|NCT02952820|183444146|SUPERIORITY||LSM Difference|5.793|STANDARD_ERROR_OF_MEAN|0.846|<|0.0001|TWO_SIDED|95.0|4.133|7.452|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||7.452|4.133|<.0001
91782212|NCT02952820|183444146|SUPERIORITY||LSM Difference|2.227|STANDARD_ERROR_OF_MEAN|0.979||0.023|TWO_SIDED|95.0|0.307|4.146|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||4.146|0.307|0.0230
91782213|NCT02952820|183444146|SUPERIORITY||LSM Difference|3.615|STANDARD_ERROR_OF_MEAN|1.01||0.0003|TWO_SIDED|95.0|1.635|5.595|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.595|1.635|0.0003
91782214|NCT02952820|183444146|SUPERIORITY||LSM Difference|4.222|STANDARD_ERROR_OF_MEAN|1.099||0.0001|TWO_SIDED|95.0|2.068|6.377|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.377|2.068|0.0001
91782215|NCT02952820|183444146|SUPERIORITY||LSM Difference|4.361|STANDARD_ERROR_OF_MEAN|1.092|<|0.0001|TWO_SIDED|95.0|2.22|6.501|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.501|2.220|<.0001
91521452|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.728|TWO_SIDED|95.0|0.93|1.05|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.05|0.93|0.728
91782216|NCT02952820|183444146|SUPERIORITY||LSM Difference|4.549|STANDARD_ERROR_OF_MEAN|1.179||0.0001|TWO_SIDED|95.0|2.236|6.861|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.861|2.236|0.0001
91782217|NCT02952820|183444146|SUPERIORITY||LSM Difference|4.667|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|2.373|6.96|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.960|2.373|<.0001
91782218|NCT02952820|183444147|SUPERIORITY||Least square mean (LSM) Difference|-14.328|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001|TWO_SIDED|95.0|-21.411|-7.245|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.245|-21.411|<.0001
91782219|NCT02952820|183444147|SUPERIORITY||LSM Difference|-16.72|STANDARD_ERROR_OF_MEAN|3.619|<|0.0001|TWO_SIDED|95.0|-23.813|-9.626|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-9.626|-23.813|<.0001
91709186|NCT03035916|183311334|OTHER|||||||0.046|||||||t-test, 2 sided|||||||0.046
91521453|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.002|TWO_SIDED|95.0|0.86|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.97|0.86|0.002
91521454|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.001|TWO_SIDED|95.0|0.84|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.95|0.84|0.001
91521455|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.823|TWO_SIDED|95.0|0.95|1.07|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.07|0.95|0.823
91521456|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.153|TWO_SIDED|95.0|0.9|1.02|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.02|0.90|0.153
91591846|NCT02807480|183073622|SUPERIORITY||Slope|0.56||||0.431|TWO_SIDED|95.0|-0.84|1.97|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||1.97|-0.84|0.431
91591847|NCT02807480|183073623|OTHER||Slope|-6.42||||0.276|TWO_SIDED|95.0|-18.15|5.3|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: approach behavior main effect||5.30|-18.15|.276
91591848|NCT02807480|183073623|SUPERIORITY||Slope|5.69||||0.52|TWO_SIDED|95.0|-12.12|23.5|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: treatment x approach behavior interaction||23.50|-12.12|.520
91591849|NCT02807480|183073623|OTHER||Slope|-50.0||||0.199|TWO_SIDED|95.0|-127.65|27.65|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: RT main effect||27.65|-127.65|.199
91591850|NCT02807480|183073623|SUPERIORITY||Slope|93.87||||0.191|TWO_SIDED|95.0|-4.14|236.88|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: treatment x RT interaction||236.88|-4.14|.191
91591851|NCT02807480|183073623|OTHER||Slope|27.35||||0.021|TWO_SIDED|95.0|4.45|50.26|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ trajectory: striatum main effect||50.26|4.45|0.021
91591852|NCT02807480|183073623|SUPERIORITY||Slope|-5.47||||0.734|TWO_SIDED|95.0|-37.94|27.0|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ post-treatment: treatment x striatum interaction effects||27.00|-37.94|.734
91591853|NCT02807480|183073623|OTHER||Slope|-9.79||||0.231|TWO_SIDED|95.0|-26.11|6.53|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: amygdala main effect||6.53|-26.11|.231
91591854|NCT02807480|183073623|SUPERIORITY||Slope|8.55||||0.602|TWO_SIDED|95.0|-24.48|41.58|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: treatment amygdala interaction||41.58|-24.48|.602
91591855|NCT02807480|183073623|OTHER||Slope|-19.29||||0.369|TWO_SIDED|95.0|-62.07|23.68|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: dlPFC main effect||23.68|-62.07|.369
91591856|NCT02807480|183073623|SUPERIORITY||Slope|9.12||||0.684|TWO_SIDED|95.0|-36.05|54.29|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: treatment x dlPFC interaction||54.29|-36.05|.684
91591857|NCT02807480|183073623|OTHER||Slope|9.6||||0.487|TWO_SIDED|95.0|-18.39|37.59|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ cores over the 10 sessions: Behavior\_change main effect||37.59|-18.39|.487
91591858|NCT02807480|183073623|SUPERIORITY||Slope|-46.34||||0.033|TWO_SIDED|95.0|-88.5|-4.18|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x Behavior\_change interaction||-4.18|-88.5|.033
91591859|NCT02807480|183073623|OTHER||Slope|39.53||||0.546|TWO_SIDED|95.0|-94.2|173.85|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: RT\_change main effect||173.85|-94.2|.546
91591860|NCT02807480|183073623|SUPERIORITY||Slope|-89.96||||0.443|TWO_SIDED|95.0|-327.39|147.67|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x RT\_change interaction||147.67|-327.39|.443
91591861|NCT02807480|183073624|OTHER||Slope|-1.01||||0.357|TWO_SIDED|95.0|-3.22|1.19|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: approach behavior main effect||1.19|-3.22|.357
91591862|NCT02807480|183073624|SUPERIORITY||Slope|0.37||||0.812|TWO_SIDED|95.0|-2.74|3.47|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: treatment x approach behavior interaction||3.47|-2.74|.812
91591863|NCT02807480|183073624|OTHER||Slope|2.01||||0.826|TWO_SIDED|95.0|-16.42|20.45|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: RT main effect||20.45|-16.42|.826
91782220|NCT02952820|183444147|SUPERIORITY||LSM Difference|-5.514|STANDARD_ERROR_OF_MEAN|4.109||0.1796|TWO_SIDED|95.0|-13.568|2.54|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||2.540|-13.568|0.1796
91782221|NCT02952820|183444147|SUPERIORITY||LSM Difference|-7.005|STANDARD_ERROR_OF_MEAN|4.129||0.0898|TWO_SIDED|95.0|-15.098|1.088|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||1.088|-15.098|0.0898
91648411|NCT00766506|183189473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.131|TWO_SIDED|95.0|0.84|3.92|||Mantel Haenszel|P-value was calculated from a Mantel-Haenszel Chi-Squared test.||||3.92|0.84|0.131
91591864|NCT02807480|183073624|SUPERIORITY||Slope|-2.89||||0.838|TWO_SIDED|95.0|-31.42|25.64|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: treatment x RT interaction||25.64|-31.42|.838
91591865|NCT02807480|183073624|OTHER||Slope|-0.68||||0.776|TWO_SIDED|95.0|-5.51|4.14|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: striatum main effect||4.14|-5.51|.776
91591866|NCT02807480|183073624|SUPERIORITY||Slope|-0.69||||0.844|TWO_SIDED|95.0|-7.79|6.4|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: treatment x striatum interaction effects||6.40|-7.79|.844
91591867|NCT02807480|183073624|OTHER||Slope|0.88||||0.719|TWO_SIDED|95.0|-4.03|5.79|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: amygdala main effect||5.79|-4.03|.719
91591868|NCT02807480|183073624|SUPERIORITY||Slope|-2.33||||0.464|TWO_SIDED|95.0|-8.74|4.07|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: treatment x amygdala interaction||4.07|-8.74|.464
91591869|NCT02807480|183073624|OTHER||Slope|5.91||||0.135|TWO_SIDED|95.0|-1.93|13.75|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: dlPFC main effect||13.75|-1.93|.135
91591870|NCT02807480|183073624|SUPERIORITY||Slope|-6.09||||0.158|TWO_SIDED|95.0|-14.65|2.47|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: treatment x dlPFC interaction||2.47|-14.65|.158
91591871|NCT02807480|183073624|OTHER||Slope|1.16||||0.69|TWO_SIDED|95.0|-4.78|7.11|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II cores over the 10 sessions: Behavior\_change main effect||7.11|-4.78|.690
91782222|NCT02952820|183444147|SUPERIORITY||LSM Difference|-13.424|STANDARD_ERROR_OF_MEAN|4.486||0.0028|TWO_SIDED|95.0|-22.218|-4.631|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-4.631|-22.218|0.0028
91782223|NCT02952820|183444147|SUPERIORITY||LSM Difference|-10.079|STANDARD_ERROR_OF_MEAN|4.578||0.0277|TWO_SIDED|95.0|-19.053|-1.104|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-1.104|-19.053|0.0277
91782224|NCT02952820|183444147|SUPERIORITY||LSM Difference|-17.474|STANDARD_ERROR_OF_MEAN|5.014||0.0005|TWO_SIDED|95.0|-27.306|-7.643|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.643|-27.306|0.0005
91782225|NCT02952820|183444147|SUPERIORITY||LSM Difference|-12.671|STANDARD_ERROR_OF_MEAN|4.951||0.0105|TWO_SIDED|95.0|-22.378|-2.964|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-2.964|-22.378|0.0105
91591872|NCT02807480|183073624|SUPERIORITY||Slope|-1.37||||0.715|TWO_SIDED|95.0|-8.99|6.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x Behavior\_change interaction||6.25|-8.99|.715
91591873|NCT02807480|183073624|OTHER||Slope|5.14||||0.74|TWO_SIDED|95.0|-26.38|36.65|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: RT\_change main effect||36.65|-26.38|.740
91591874|NCT02807480|183073624|SUPERIORITY||Slope|-0.98||||0.966|TWO_SIDED|95.0|-48.1|46.14|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x RT\_change interaction||46.14|-48.10|.966
91591875|NCT02081534|183073641|SUPERIORITY|||||||0.012|||||||ANCOVA|||||||0.012
91591876|NCT02716675|183073735|OTHER||Prevention Efficacy (PE)|26.6||||0.15|TWO_SIDED|95.0|-11.7|51.8||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||51.8|-11.7|0.15
91591877|NCT02716675|183073735|OTHER||Prevention Efficacy (PE)|22.4|||||TWO_SIDED|95.0|-25.5|52.0||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||52.0|-25.5|
91591878|NCT02716675|183073735|OTHER||Prevention Efficacy (PE)|30.9|||||TWO_SIDED|95.0|-13.9|58.0||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||58.0|-13.9|
91591879|NCT02716675|183073737|OTHER||Prevention Efficacy (PE)|73.0|||||TWO_SIDED|95.0|27.6|89.9||||||PE against IC80 of least sensitive variant less than 1||89.9|27.6|
91591880|NCT02716675|183073737|OTHER||Prevention Efficacy (PE)|6.1|||||TWO_SIDED|95.0|-174.3|67.8||||||PE against IC80 of least sensitive variant 1-3||67.8|-174.3|
91591881|NCT02716675|183073737|OTHER||Prevention Efficacy (PE)|8.6|||||TWO_SIDED|95.0|-68.1|50.3||||||PE against IC80 of least sensitive variant \> 3||50.3|-68.1|
91591882|NCT02015442|183073740|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline vs. treatment period||||0.390
91591883|NCT02015442|183073740|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Baseline vs treatment||||0.204
91591884|NCT02015442|183073741|SUPERIORITY|||||||0.001||||||calculated|t-test, 2 sided|||Baseline vs treatment||||0.001
91591885|NCT02015442|183073741|SUPERIORITY|||||||0.244|||||||t-test, 2 sided|||Baseline vs treatment||||0.244
91591886|NCT02015442|183073741|SUPERIORITY|||||||0.244|||||||ANOVA|||||||0.244
91648412|NCT00766506|183189474|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.342
91648413|NCT00766506|183189475|SUPERIORITY_OR_OTHER|||||||0.836|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.836
91591887|NCT00290290|183073742|SUPERIORITY_OR_OTHER||Relative Risk|0.59||||0.004|TWO_SIDED|95.0|0.41|0.85|||Log Rank|||The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.||0.85|0.41|0.004
91591888|NCT00003895|183073744|SUPERIORITY_OR_OTHER||||||<|0.001||||||Post versus Pre-treatment % g209-2M-specific t-cells|t-test, 2 sided|||||||<.001
91591889|NCT00003895|183073744|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Post versus Pre-Treatment %g209-2M-specific T-cells|t-test, 2 sided|||||||<.0001
91591890|NCT00003895|183073744|SUPERIORITY_OR_OTHER|||||||0.59||||||Arm A Versus Arm B|t-test, 2 sided|||||||0.59
91591891|NCT01380730|183073745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.1|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-71.48|-60.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.72|-71.48|<0.001
91591892|NCT01380730|183073745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.24|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-65.61|-54.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.88|-65.61|<0.001
91591893|NCT01380730|183073745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.82|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-47.18|-36.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.45|-47.18|<0.001
91591894|NCT01380730|183073745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.33|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-56.04|-44.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.62|-56.04|<0.001
91591895|NCT01380730|183073745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.0|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-55.69|-44.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.31|-55.69|<0.001
91591896|NCT01380730|183073745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.84|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-47.55|-36.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.13|-47.55|<0.001
91591897|NCT01380730|183073746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-87.0|-71.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-71.5|-87.0|<0.001
91591898|NCT01380730|183073746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-85.2|-69.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-69.6|-85.2|<0.001
91591899|NCT01380730|183073746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.7|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-58.5|-43.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.0|-58.5|<0.001
91591900|NCT01380730|183073746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.6|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.6|<0.001
91591901|NCT01380730|183073746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.5|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.5|<0.001
91591902|NCT01380730|183073746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-58.0|-43.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.1|-58.0|<0.001
91591903|NCT01380730|183073747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|-66.37|-56.43||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-56.43|-66.37|<0.001
91591904|NCT01380730|183073747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.42|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-60.37|-50.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-50.47|-60.37|<0.001
91648414|NCT00766506|183189476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.029|TWO_SIDED|95.0|1.04|24.03|||Chi-squared|||||24.03|1.04|0.029
91709187|NCT03035916|183311334|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
91591905|NCT01380730|183073747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-43.39|-33.48||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-33.48|-43.39|<0.001
91591906|NCT01380730|183073747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.58|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-52.72|-42.44||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.44|-52.72|<0.001
91591907|NCT01380730|183073747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-50.92|-40.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-40.67|-50.92|<0.001
91591908|NCT01380730|183073747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-42.94|-32.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-32.65|-42.94|<0.001
91591909|NCT01380730|183073748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.45|STANDARD_ERROR_OF_MEAN|2.46|<|0.001|TWO_SIDED|95.0|-61.28|-51.61||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-51.61|-61.28|<0.001
91591910|NCT01380730|183073748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.15|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-54.97|-45.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-45.33|-54.97|<0.001
91591911|NCT01380730|183073748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.74|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-39.56|-29.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.92|-39.56|<0.001
91591912|NCT01380730|183073748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.03|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-47.16|-36.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.90|-47.16|<0.001
91709188|NCT03035916|183311335|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.910
91782226|NCT02952820|183444148|SUPERIORITY||LSM Difference|22.034|STANDARD_ERROR_OF_MEAN|4.354|<|0.0001|TWO_SIDED|95.0|13.488|30.579|||Mixed Models Analysis|||First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||30.579|13.488|<.0001
91782227|NCT02952820|183444148|SUPERIORITY||LSM Difference|31.796|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|23.258|40.334|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||40.334|23.258|<.0001
91782228|NCT02952820|183444148|SUPERIORITY||LSM Difference|11.76|STANDARD_ERROR_OF_MEAN|5.269||0.0259|TWO_SIDED|95.0|1.418|22.102|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||22.102|1.418|0.0259
91591913|NCT01380730|183073748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.77|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-45.88|-35.66||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-35.66|-45.88|<0.001
91591914|NCT01380730|183073748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.38|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-39.51|-29.25||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.25|-39.51|<0.001
91591915|NCT01380730|183073749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-52.18|-43.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.29|-52.18|<0.001
91591916|NCT01380730|183073749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.38|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-47.81|-38.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-38.94|-47.81|<0.001
91591917|NCT01380730|183073749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.4|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-35.83|-26.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-26.97|-35.83|<0.001
91591918|NCT01380730|183073749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.65|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-39.99|-31.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.32|-39.99|<0.001
91709189|NCT03035916|183311335|OTHER|||||||0.864|||||||t-test, 2 sided|||||||0.864
91709190|NCT03035916|183311335|OTHER|||||||0.785|||||||t-test, 2 sided|||||||0.785
91709191|NCT03035916|183311336|OTHER|||||||0.972|||||||t-test, 2 sided|||||||0.972
91709192|NCT03035916|183311336|OTHER|||||||0.987|||||||t-test, 2 sided|||||||0.987
91709193|NCT03035916|183311336|OTHER|||||||0.518|||||||t-test, 2 sided|||||||0.518
91521457|NCT01218126|182917376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.126|TWO_SIDED|95.0|0.9|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.01|0.90|0.126
91521458|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87||||0.291|TWO_SIDED|95.0|0.68|1.12|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.12|0.68|0.291
91521459|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.046|TWO_SIDED|95.0|0.61|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||1.00|0.61|0.046
91521460|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.014|TWO_SIDED|95.0|0.57|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.94|0.57|0.014
91521461|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04||||0.755|TWO_SIDED|95.0|0.82|1.32|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.32|0.82|0.755
91521462|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.029|TWO_SIDED|95.0|0.6|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.97|0.60|0.029
91521463|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.015|TWO_SIDED|95.0|0.58|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.94|0.58|0.015
91521464|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.468|TWO_SIDED|95.0|0.71|1.17|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.17|0.71|0.468
91521465|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.011||95.0|0.57|0.93|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.93|0.57|0.011
91521466|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0|TWO_SIDED|95.0|0.5|0.82|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.82|0.50|0.000
91521467|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.696|TWO_SIDED|95.0|0.74|1.22|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.22|0.74|0.696
91521468|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81||||0.099|TWO_SIDED|95.0|0.64|1.04|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.04|0.64|0.099
91521469|NCT01218126|182917377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.11|0.67|0.256
91521470|NCT01218126|182917378|SUPERIORITY_OR_OTHER||Rate ratio|1.0||||0.989|TWO_SIDED|95.0|0.64|1.54|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 2.5 mg arm) / (Rate of exacerbation in placebo arm)|Losmapimod 2.5 mg versus Placebo||1.54|0.64|0.989
91521471|NCT01218126|182917378|SUPERIORITY_OR_OTHER||Rate ratio|0.98||||0.915||95.0|0.64|1.5|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 7.5 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 7.5 mg||1.50|0.64|0.915
91648415|NCT00766506|183189478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.23|TWO_SIDED|95.0|0.74|3.53|||Chi-squared|||Paracetamol: P-value was calculated using Chi-squared test.||3.53|0.74|0.230
91591919|NCT01380730|183073749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.97|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-40.29|-31.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.65|-40.29|<0.001
91591920|NCT01380730|183073749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.73|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-32.06|-23.39||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-23.39|-32.06|<0.001
91591921|NCT01380730|183073750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-58.23|-48.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-48.65|-58.23|<0.001
91591922|NCT01380730|183073750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.3|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-52.08|-42.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.52|-52.08|<0.001
91591923|NCT01380730|183073750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-39.53|-29.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.97|-39.53|<0.001
91591924|NCT01380730|183073750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.93|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-48.36|-37.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-37.50|-48.36|<0.001
91591925|NCT01380730|183073750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.4|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-47.81|-36.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.98|-47.81|<0.001
91591926|NCT01380730|183073750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.77|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-39.2|-28.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-28.33|-39.20|<0.001
91591927|NCT00962390|183073751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4678|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4678
91782229|NCT02952820|183444148|SUPERIORITY||LSM Difference|22.131|STANDARD_ERROR_OF_MEAN|5.286|<|0.0001|TWO_SIDED|95.0|11.757|32.505|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||32.505|11.757|<.0001
91782230|NCT02952820|183444148|SUPERIORITY||LSM Difference|17.374|STANDARD_ERROR_OF_MEAN|5.906||0.0034|TWO_SIDED|95.0|5.781|28.968|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||28.968|5.781|0.0034
91782231|NCT02952820|183444148|SUPERIORITY||LSM Difference|21.686|STANDARD_ERROR_OF_MEAN|5.946||0.0003|TWO_SIDED|95.0|10.014|33.359|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||33.359|10.014|0.0003
91591928|NCT00962390|183073751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4892|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4892
91591929|NCT00962390|183073751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8185|TWO_SIDED|95.0|-0.8|1.0||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.0|-0.8|0.8185
91591930|NCT00766090|183073778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.064|0.153|||ANCOVA|||||0.153|0.064|<0.001
91591931|NCT00766090|183073778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.054|0.142|||ANCOVA|||||0.142|0.054|<0.001
91591932|NCT00766090|183073778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087||||0.02|TWO_SIDED|95.0|0.014|0.161|||ANCOVA|||||0.161|0.014|0.020
91648416|NCT00766506|183189478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.163|TWO_SIDED|95.0|0.8|3.7|||Chi-squared|||NSAID's: P-value was calculated using Chi-squared test.||3.70|0.80|0.163
91648417|NCT03053622|183189480|OTHER||Ratio of Geometric Least Squares Means|0.996|||||TWO_SIDED|90.0|0.807|1.23||||||||1.23|0.807|
91782232|NCT02952820|183444148|SUPERIORITY||LSM Difference|18.555|STANDARD_ERROR_OF_MEAN|6.324||0.0034|TWO_SIDED|95.0|6.14|30.969|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).||30.969|6.140|0.0034
91782233|NCT02952820|183444148|SUPERIORITY||LSM Difference|22.686|STANDARD_ERROR_OF_MEAN|6.392||0.0004|TWO_SIDED|95.0|10.137|35.234|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||35.234|10.137|0.0004
91521472|NCT01218126|182917378|SUPERIORITY_OR_OTHER||Rate ratio|0.74||||0.21|TWO_SIDED|95.0|0.47|1.18|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 15 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 15 mg||1.18|0.47|0.210
91521473|NCT05380947|182917385|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T1/R)|135.2|||||TWO_SIDED|90.0|99.7|183.6|||||Unit of adjusted geometric means ratio (T1/R) is %. Unit of 90% Confidence Interval is %. Intra-individual geometric coefficient of variation (gCV) = 39.7%|||183.6|99.7|
91521474|NCT05380947|182917385|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T2/T1)|74.2|||||TWO_SIDED|90.0|67.6|81.6|||||Unit of adjusted geometric means ratio (T2/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual geometric coefficient of variation (gCV) = 9.8%|||81.6|67.6|
91521475|NCT05380947|182917385|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T3/T1)|97.1|||||TWO_SIDED|90.0|85.8|110.0|||||Unit of adjusted geometric means ratio (T3/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual geometric coefficient of variation (gCV) = 13.8%|||110.0|85.8|
91521476|NCT05380947|182917386|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T1/R)|139.3|||||TWO_SIDED|90.0|87.7|221.3|||||Unit of adjusted geometric means ratio (T1/R) is %. Unit of 90% Confidence Interval is %. Intra-individual coefficient of variation (gCV) = 62.3%|||221.3|87.7|
91521477|NCT05380947|182917386|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T2/T1)|53.5|||||TWO_SIDED|90.0|40.5|70.8|||||Unit of adjusted geometric means ratio (T2/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual coefficient of variation (gCV) = 31.0%|||70.8|40.5|
91782234|NCT02952820|183444149|SUPERIORITY||Difference of percentage|13.67||||0.0004|TWO_SIDED|95.0|6.24|21.1|||Cochran-Mantel-Haenszel|||Sleep onset responders: Statistical analysis 1||21.10|6.24|0.0004
91782235|NCT02952820|183444149|SUPERIORITY||Difference of percentage|12.53||||0.0009|TWO_SIDED|95.0|5.2|19.86|||Cochran-Mantel-Haenszel|||Sleep Onset Responders: Statistical analysis 2||19.86|5.20|0.0009
91782236|NCT02952820|183444149|SUPERIORITY||Difference of percentage|14.65||||0.0002|TWO_SIDED|95.0|6.97|22.33|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 3||22.33|6.97|0.0002
91782237|NCT02952820|183444149|SUPERIORITY||Difference of percentage|9.82||||0.011|TWO_SIDED|95.0|2.29|17.35|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 4||17.35|2.29|0.0110
91782238|NCT02952820|183444151|SUPERIORITY||LSM Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.287||0.0137|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.15|-1.27|0.0137
91782239|NCT02952820|183444151|SUPERIORITY||LSM Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.289||0.0011|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.38|-1.51|0.0011
91782240|NCT02952820|183444151|SUPERIORITY||LSM Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.302||0.0001|TWO_SIDED|95.0|-1.75|-0.57|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.57|-1.75|0.0001
91591933|NCT00766090|183073778|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters.|Mean Difference (Final Values)|0.011||||0.641|TWO_SIDED|95.0|-0.035|0.056|||ANCOVA|||||0.056|-0.035|0.641
91591934|NCT00766090|183073778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|||<|0.001|TWO_SIDED|95.0|0.059|0.205|||ANCOVA|||||0.205|0.059|<0.001
91521478|NCT05380947|182917386|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T3/T1)|87.0|||||TWO_SIDED|90.0|66.8|113.2|||||Unit of adjusted geometric means ratio (T3/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual coefficient of variation (gCV) = 30.5%|||113.2|66.8|
91521479|NCT05380947|182917387|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T1/R)|129.1|||||TWO_SIDED|90.0|96.2|173.4|||||Unit of adjusted geometric means ratio (T1/R) is %. Unit of 90% Confidence Interval is %. Intra-individual coefficient of variation (gCV) =36.6%|||173.4|96.2|
91521480|NCT05380947|182917387|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T2/T1)|74.9|||||TWO_SIDED|90.0|68.6|81.7|||||Unit of adjusted geometric means ratio (T2/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual coefficient of variation (gCV) = 9.0%|||81.7|68.6|
91591935|NCT03591354|183073907|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91591936|NCT02463071|183073999|SUPERIORITY||Mean Difference (Final Values)|-26.72|STANDARD_ERROR_OF_MEAN|4.96|<|0.0001|TWO_SIDED|95.0|-36.55|-16.88|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-16.88|-36.55|<0.0001
91591937|NCT02463071|183073999|SUPERIORITY||Mean Difference (Final Values)|-32.92|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|-42.93|-22.92|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-22.92|-42.93|<0.0001
91648418|NCT03053622|183189480|OTHER||Ratio of Geometric Least Squares Means|0.729|||||TWO_SIDED|90.0|0.591|0.898||||||||0.898|0.591|
91648419|NCT03053622|183189480|OTHER||Ratio of Geometric Least Squares Means|0.422|||||TWO_SIDED|90.0|0.343|0.518||||||||0.518|0.343|
91591938|NCT01499953|183074088|NON_INFERIORITY|The hypotheses for non-inferiority test using ∆=4.5% for the difference between incidence rates were H0: πrivaroxaban-πfondaparinux ≥ 4.5%, H1: πrivaroxaban-πfondaparinux \< 4.5% where πfondaparinux and πrivaroxaban were the incidence rates of CIAC confirmed VTE complications up to Day 45 in the treatment groups. Rejection of the null hypothesis would have concluded that rivaroxaban was not inferior to fondaparinux. To calculate the p-value, an asymptotic test for non-inferiority was used.||||||0.0252|||||||asymptotic test for non-inferiority|||||||0.0252
91591939|NCT03734016|183074103|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.12|||<|0.0001|TWO_SIDED|95.0|1.04|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.04|<0.0001
91591940|NCT03734016|183074103|SUPERIORITY|||||||0.0035||||||Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0035
91591941|NCT03734016|183074104|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.05|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.05|<0.0001
91591942|NCT03734016|183074104|SUPERIORITY|Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.||||||0.0007|||||||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0007
91591943|NCT03734016|183074105|NON_INFERIORITY|Non-inferiority was tested with a non-inferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
91782241|NCT02952820|183444151|SUPERIORITY||LSM Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-1.96|-0.76|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.76|-1.96|<.0001
91782242|NCT02952820|183444151|SUPERIORITY||LSM Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.302|<|0.0001|TWO_SIDED|95.0|-1.9|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.90|<.0001
91782243|NCT02952820|183444151|SUPERIORITY||LSM Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-1.92|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.92|<.0001
91591944|NCT03734016|183074105|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
91591945|NCT03734016|183074106|NON_INFERIORITY|Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86||Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Stratified Wald test||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
91782244|NCT02952820|183444152|SUPERIORITY||LSM Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.905||0.067|TWO_SIDED|95.0|-3.44|0.12|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||0.12|-3.44|0.0670
91591946|NCT03734016|183074106|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
91591947|NCT03734016|183074107|SUPERIORITY||Rate Difference|-8.0||||0.0004|TWO_SIDED|95.0|-12.4|-3.6|||Chi-squared||Rate difference is the zanubrutinib rate minus the ibrutinib rate.|||-3.6|-12.4|0.0004
91591948|NCT03734016|183074110|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.41|0.72|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.72|0.41|
91591949|NCT03734016|183074113|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.11|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.11|0.51|
91591950|NCT03734016|183074114|OTHER||Least Squares (LS) Mean Difference|3.0||||0.0338|TWO_SIDED|95.0|0.23|5.77|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 24. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||5.77|0.23|0.0338
91591951|NCT03734016|183074114|OTHER||LS Mean Difference|1.34||||0.3304|TWO_SIDED|95.0|-1.37|4.06|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 48. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||4.06|-1.37|0.3304
91591952|NCT03734016|183074114|OTHER||LS Mean Difference|1.82||||0.1189|TWO_SIDED|95.0|-0.47|4.12|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||4.12|-0.47|0.1189
91782245|NCT02952820|183444152|SUPERIORITY||LSM Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.913||0.0257|TWO_SIDED|95.0|-3.83|-0.25|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.25|-3.83|0.0257
91782246|NCT02952820|183444152|SUPERIORITY||LSM Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.939||0.0206|TWO_SIDED|95.0|-4.02|-0.34|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.34|-4.02|0.0206
91782247|NCT02952820|183444152|SUPERIORITY||LSM Difference|-3.04|STANDARD_ERROR_OF_MEAN|0.95||0.0014|TWO_SIDED|95.0|-4.91|-1.18|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-1.18|-4.91|0.0014
91648420|NCT03053622|183189480|OTHER||Ratio of Geometric Least Squares Means|0.307|||||TWO_SIDED|90.0|0.249|0.379||||||||0.379|0.249|
91648421|NCT03053622|183189481|OTHER||Ratio of Geometric Least Squares Means|0.986|||||TWO_SIDED|90.0|0.81|1.2||||||||1.20|0.810|
91782248|NCT02952820|183444152|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.112||0.0134|TWO_SIDED|95.0|-4.48|-0.52|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.52|-4.48|0.0134
91782249|NCT02952820|183444152|SUPERIORITY||LSM Difference|-2.56|STANDARD_ERROR_OF_MEAN|1.026||0.0128|TWO_SIDED|95.0|-4.57|-0.54|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.54|-4.57|0.0128
91782250|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.205|STANDARD_ERROR_OF_MEAN|0.076||0.0067|TWO_SIDED|95.0|0.057|0.353|||Mixed Models Analysis|||First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.353|0.057|0.0067
91782251|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.171|STANDARD_ERROR_OF_MEAN|0.076||0.0237|TWO_SIDED|95.0|0.023|0.32|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.320|0.023|0.0237
91782252|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.077|STANDARD_ERROR_OF_MEAN|0.094||0.412|TWO_SIDED|95.0|-0.107|0.261|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.261|-0.107|0.4120
91782253|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.073|STANDARD_ERROR_OF_MEAN|0.094||0.4347|TWO_SIDED|95.0|-0.111|0.258|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.258|-0.111|0.4347
91782254|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.074|STANDARD_ERROR_OF_MEAN|0.109||0.4992|TWO_SIDED|95.0|-0.141|0.289|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.289|-0.141|0.4992
91591953|NCT03734016|183074114|OTHER||LS Mean Difference|1.15||||0.3274|TWO_SIDED|95.0|-1.15|3.44|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.44|-1.15|0.3274
91709194|NCT01402986|183311343|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.709|TWO_SIDED|95.0|0.67|1.31|||Poisson regression|||The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus \[vs\] more than \[\>\] 2 but less than or equal to \[=\<\] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.||1.31|0.67|0.709
91782255|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.255|STANDARD_ERROR_OF_MEAN|0.11||0.0208|TWO_SIDED|95.0|0.039|0.471|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.471|0.039|0.0208
91782256|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.144|STANDARD_ERROR_OF_MEAN|0.119||0.2248|TWO_SIDED|95.0|-0.089|0.378|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.378|-0.089|0.2248
91782257|NCT02952820|183444153|SUPERIORITY||LSM Difference|0.261|STANDARD_ERROR_OF_MEAN|0.12||0.0298|TWO_SIDED|95.0|0.026|0.497|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.497|0.026|0.0298
91782258|NCT03070964|183444171|SUPERIORITY||Exact binomial estimator|16.7|||||TWO_SIDED|95.0|2.1|48.4||||||||48.4|2.1|
91591954|NCT03734016|183074114|OTHER||LS Mean Difference|0.63||||0.6821|TWO_SIDED|95.0|-2.4|3.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.66|-2.40|0.6821
91591955|NCT03734016|183074114|OTHER||LS Mean Difference|1.8||||0.2701|TWO_SIDED|95.0|-1.4|5.0|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||5.00|-1.40|0.2701
91782259|NCT01600170|183444174|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.39
91782260|NCT01600170|183444175|SUPERIORITY||||||<|0.45||||||Threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||<0.45
91591956|NCT03734016|183074115|OTHER||LS Mean Difference|-1.91||||0.1778|TWO_SIDED|95.0|-4.7|0.87|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.87|-4.70|0.1778
91790207|NCT00095147|183459635|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3|||<|0.001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.15|-0.45|<0.001
91790208|NCT00095147|183459637|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|4.02|||<|0.001|TWO_SIDED|95.0|1.92|6.12|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||6.12|1.92|<0.001
91790209|NCT00095147|183459637|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|3.51||||0.004|TWO_SIDED|95.0|1.1|5.91|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.91|1.10|0.004
91790210|NCT00095147|183459637|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|3.32||||0.002|TWO_SIDED|95.0|1.25|5.4|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.40|1.25|0.002
91591957|NCT03734016|183074115|OTHER||LS Mean Difference|-0.35||||0.8174|TWO_SIDED|95.0|-3.32|2.62|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||2.62|-3.32|0.8174
91591958|NCT03734016|183074115|OTHER||LS Mean Difference|-0.29||||0.6294|TWO_SIDED|95.0|-1.48|0.89|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.89|-1.48|0.6294
91591959|NCT03734016|183074115|OTHER||LS Mean Difference|-0.51||||0.4933|TWO_SIDED|95.0|-1.99|0.96|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.96|-1.99|0.4933
91591960|NCT03734016|183074115|OTHER||LS Mean Difference|-1.43||||0.3643|TWO_SIDED|95.0|-4.51|1.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||1.66|-4.51|0.3643
91591961|NCT03734016|183074115|OTHER||LS Mean Difference|-2.43||||0.1363|TWO_SIDED|95.0|-5.62|0.77|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.77|-5.62|0.1363
91591962|NCT03734016|183074115|OTHER||LS Mean Difference|-1.59||||0.2001|TWO_SIDED|95.0|-4.01|0.84|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.84|-4.01|0.2001
91591963|NCT03734016|183074115|OTHER||LS Mean Difference|-1.85||||0.1121|TWO_SIDED|95.0|-4.12|0.43|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.43|-4.12|0.1121
91591964|NCT01624259|183074120|NON_INFERIORITY_OR_EQUIVALENCE|"Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy.~This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks."|LS Mean Difference|-0.06|||<|0.001|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment).|Mixed Models Analysis|||To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.||0.07|-0.19|<0.001
91591965|NCT01624259|183074120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.186|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment)|Mixed Models Analysis|||Superiority analysis||0.07|-0.19|0.186
91591966|NCT01624259|183074121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.28||0.01|TWO_SIDED|95.0|0.17|1.26||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model at 26 weeks.||1.26|0.17|0.010
91591967|NCT01624259|183074122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|0.05|0.45||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||0.45|0.05|0.013
91591968|NCT01624259|183074123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|2.61||0.828|TWO_SIDED|95.0|-5.69|4.56||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||4.56|-5.69|0.828
91782261|NCT01600170|183444176|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.80
91790211|NCT00095147|183459637|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|2.68||||0.027|TWO_SIDED|95.0|0.31|5.05|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.05|0.31|0.027
91591969|NCT01624259|183074124|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25|STANDARD_ERROR_OF_MEAN|1.86||0.228|TWO_SIDED|95.0|-5.91|1.41||No adjustment for multiplicity.|Mixed Models Analysis|P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM.||||1.41|-5.91|0.228
91591970|NCT01624259|183074125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.322|TWO_SIDED|95.0|0.81|1.86||P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).|Regression, Logistic|No adjustment for multiplicity.||Treatment comparison for HbA1c levels ≤6.5%||1.86|0.81|0.322
91648422|NCT03053622|183189481|OTHER||Ratio of Geometric Least Squares Means|0.753|||||TWO_SIDED|90.0|0.619|0.916||||||||0.916|0.619|
91782262|NCT01600170|183444177|SUPERIORITY|||||||0.04||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.04
91591971|NCT01624259|183074125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.925|TWO_SIDED|95.0|0.64|1.63||No adjustment for multiplicity.|Regression, Logistic|P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).||Treatment comparison for HbA1c levels \<7.0%.||1.63|0.64|0.925
91591972|NCT01624259|183074126|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.79||0.608|TWO_SIDED|95.0|-4.06|6.92|||ANCOVA|No adjustment for multiplicity.||||6.92|-4.06|0.608
91591973|NCT02273726|183074160|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001|TWO_SIDED|95.0|0.365|0.591|||ANCOVA|ANCOVA with MI||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening hemoglobin (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.591|0.365|<0.0001
91591974|NCT02273726|183074161|NON_INFERIORITY|The non-inferiority was established when the 2-sided 95% CI for the difference of LS means between the 2 treatment groups using the MMRM model lay entirely above -0.75 g/dL.|LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.404|0.687|||Mixed Models Analysis|||Treatment comparison was made using a mixed model of repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.687|0.404|<0.0001
91591975|NCT02273726|183074162|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|7.6|||||TWO_SIDED|95.0|0.9|14.3||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||14.3|0.9|
91591976|NCT02273726|183074163|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|2.7|||||TWO_SIDED|95.0|-4.3|9.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||9.7|-4.3|
91591977|NCT02273726|183074164|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|Least Square Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.514|<|0.0001|TWO_SIDED|95.0|-17.64|-11.695|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-11.695|-17.640|<0.0001
91782263|NCT01600170|183444178|SUPERIORITY|||||||0.15||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.15
91591978|NCT02273726|183074165|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|0.503|0.869||Threshold for significance at 0.05 level.|ANCOVA|ANCOVA with MI||Treatment comparison was made using the MI strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.869|0.503|<0.0001
91591979|NCT02273726|183074166|SUPERIORITY||LS Mean Difference|-20.14|STANDARD_ERROR_OF_MEAN|6.975||0.00091|TWO_SIDED|95.0|-33.842|-6.445||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-6.445|-33.842|0.00091
91591980|NCT02273726|183074167|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|0.67||||0.0337|TWO_SIDED|95.0|0.466|0.97|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.970|0.466|0.0337
91591981|NCT02273726|183074168|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.739||0.35|TWO_SIDED|95.0|-0.76|2.142|||Mixed Models Analysis|||Treatment comparison was made using MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||2.142|-0.760|0.3500
91591982|NCT03697720|183074181|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was .05|t-test, 2 sided|Paired t-test||Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.||||<0.0001
91591983|NCT03697720|183074182|SUPERIORITY|||||||0.119|||||||t-test, 2 sided|paired t-test||||||.119
91591984|NCT02414399|183074188|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.29||Alpha =0.045 (to account for .005 alpha spending at interim analysis)|Regression, Cox||azithromycin is the numerator and placebo is the denominator|Death or rehospitalization||1.29|.64|0.58
91591985|NCT02414399|183074188|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.49|TWO_SIDED|95.0|0.39|1.58|||Regression, Cox||Azithromycin-numerator and placebo-denominator|Death alone||1.58|0.39|0.49
91591986|NCT02414399|183074188|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.7|1.47|||Regression, Cox||numerator-azithromycin denominator-placebo|Rehospitalization alone||1.47|.70|.94
91591987|NCT02414399|183074196|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.77|||||||Chi-squared|||M0||||0.77
91591988|NCT02414399|183074196|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.088|||||||Chi-squared|||Month 3||||0.088
91591989|NCT02414399|183074196|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.44|||||||Chi-squared|||M6||||0.44
91782264|NCT01600170|183444179|SUPERIORITY|||||||0.63||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.63
91790212|NCT00534313|183459750|SUPERIORITY_OR_OTHER||Difference|22.9||||0.022|TWO_SIDED|95.0|4.0|41.8||The p-value (two-sided) was based on Cochran-Mantel-Haenszel method (CMH) with stratification of baseline body surface area (BSA) affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||41.8|4.0|0.022
91591990|NCT01704287|183074211|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels \[≥110% Upper Limit of Normal (ULN)\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|||0.73|0.46|<0.0001
91591991|NCT01704287|183074211|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.37|0.6||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|||0.60|0.37|<0.0001
91648423|NCT03053622|183189482|OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.1|48.4||||||||48.40|-0.10|
91521481|NCT05380947|182917387|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted geometric means ratio (T3/T1)|96.9|||||TWO_SIDED|90.0|85.3|110.2|||||Unit of adjusted geometric means ratio (T3/T1) is %. Unit of 90% Confidence Interval is %. Intra-individual coefficient of variation (gCV) = 14.2%|||110.2|85.3|
91521482|NCT01563536|182917398|SUPERIORITY_OR_OTHER||Mean Difference (Maximal Decrease)|-1.5||||0.035|TWO_SIDED|95.0|-2.81|-0.13||Pre-specified 2-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.||||-0.13|-2.81|0.035
91521483|NCT01860703|182917400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||||TWO_SIDED|90.0|1.02|5.01||||||||5.01|1.02|
91521484|NCT01860703|182917406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23|||||TWO_SIDED|90.0|3.26|7.19||||||||7.19|3.26|
91521485|NCT01860703|182917409|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|13.42|||||TWO_SIDED|90.0|11.1|15.75||||||||15.75|11.10|
91521486|NCT02532556|182917412|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
91521487|NCT02532556|182917413|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
91521488|NCT00538590|182917427|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.95
91521489|NCT00538590|182917429|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||1.00
91521490|NCT00538590|182917430|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.40
91521491|NCT00538590|182917431|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.91
91521492|NCT03184792|182917465|SUPERIORITY||Mean Difference (Final Values)|9.5|||<|0|TWO_SIDED|95.0|6.6|12.4|||ANOVA|||||12.4|6.6|<0.000
91591992|NCT01704287|183074211|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.83||||0.1247|TWO_SIDED|95.0|0.66|1.05||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|||1.05|0.66|0.1247
91591993|NCT01704287|183074212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1173|TWO_SIDED|95.0|0.67|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.67|0.1173
91591994|NCT01704287|183074212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0106|TWO_SIDED|95.0|0.57|0.96||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.96|0.57|0.0106
91591995|NCT01704287|183074212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2905|TWO_SIDED|95.0|0.67|1.12||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.12|0.67|0.2905
91591996|NCT01704287|183074213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1146|TWO_SIDED|95.0|0.68|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.68|0.1146
91591997|NCT01704287|183074213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0023|TWO_SIDED|95.0|0.55|0.9||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.90|0.55|0.0023
91591998|NCT01704287|183074213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.149|TWO_SIDED|95.0|0.66|1.07||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.07|0.66|0.1490
91591999|NCT01704287|183074214|SUPERIORITY_OR_OTHER_LEGACY|PD-L1-Positive Participants|Hazard Ratio (HR)|0.92||||0.3113|TWO_SIDED|95.0|0.66|1.28||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.28|0.66|0.3113
91592000|NCT01704287|183074214|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.5|0.99||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.99|0.50|0.0208
91782265|NCT01600170|183444180|SUPERIORITY|||||||0.035||||||Threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.035
91782266|NCT01600170|183444181|SUPERIORITY|||||||0.62||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.62
91790213|NCT00534313|183459750|SUPERIORITY_OR_OTHER||Difference|28.7||||0.006|TWO_SIDED|95.0|9.4|48.0||p-value (two-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||48.0|9.4|0.006
91790214|NCT00534313|183459750|SUPERIORITY_OR_OTHER||Difference|14.6||||0.121|TWO_SIDED|95.0|-3.5|32.6||p-value (2-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||32.6|-3.5|0.121
91790215|NCT00534313|183459757|SUPERIORITY_OR_OTHER||Difference|-6.0|||||TWO_SIDED|95.0|-23.0|11.0|||Cochran-Mantel-Haenszel||Difference and 95% confidence intervals (CI) was based on CMH with stratification of baseline BSA affected by psoriasis.|||11.0|-23.0|
91790216|NCT00534313|183459757|SUPERIORITY_OR_OTHER||Difference|-0.5|||||TWO_SIDED|95.0|-18.0|17.1|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||17.1|-18.0|
91790217|NCT00534313|183459757|SUPERIORITY_OR_OTHER||Difference|10.4|||||TWO_SIDED|95.0|-7.6|28.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||28.5|-7.6|
91790218|NCT00534313|183459758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.77|||||TWO_SIDED|95.0|-7.02|44.56|||ANCOVA|||||44.56|-7.02|
91790219|NCT00534313|183459758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.34|||||TWO_SIDED|95.0|-3.93|48.6|||ANCOVA|||||48.60|-3.93|
91790220|NCT00534313|183459758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.48|||||TWO_SIDED|95.0|4.82|56.15|||ANCOVA|||||56.15|4.82|
91592001|NCT01704287|183074214|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.71||||0.0496|TWO_SIDED|95.0|0.5|1.0||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.00|0.50|0.0496
91592002|NCT01704287|183074214|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|1.07||||0.6043|TWO_SIDED|95.0|0.65|1.76||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.76|0.65|0.6043
91592003|NCT01704287|183074214|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.62||||0.0335|TWO_SIDED|95.0|0.37|1.04||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.04|0.37|0.0335
91592004|NCT01704287|183074214|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.71||||0.1504|TWO_SIDED|95.0|0.44|1.13||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.13|0.44|0.1504
91592005|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.9|||||TWO_SIDED|95.0|1.58|2.28||||||A/H1N1: 60-64 years||2.28|1.58|
91592006|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.7|||||TWO_SIDED|95.0|1.38|2.08||||||A/H3N2: 60-64 years||2.08|1.38|
91782267|NCT01600170|183444182|SUPERIORITY|||||||0.99||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.99
91782268|NCT02970162|183444192|SUPERIORITY|||||||0.0004||||||LS means|Least square means|Fixed effects treatment and QMG at Baseline. Between-treatment difference in LS means (95% CI) -6.54 (-9.78, -3.29).||||||0.0004
91782269|NCT02970162|183444193|SUPERIORITY||LS means|2.95||||0.0003|TWO_SIDED|95.0|1.53|4.38||CFB for SGI score was modeled as the response, with fixed effects terms for treatment and SGI at Baseline|Fixed effects linear model|This statistical test applies to the change from baseline SGI scores to Day 4 values row.||||4.38|1.53|0.0003
91782270|NCT02970162|183444194|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||||||0.0020
91782271|NCT02970162|183444195|SUPERIORITY|||||||0.0112|||||||Fisher Exact|||||||0.0112
91782272|NCT00750438|183444210|SUPERIORITY|||||||0.972|||||||Regression, Linear|||||||0.972
91782273|NCT00750438|183444211|SUPERIORITY|||||||0.559|||||||t-test, 2 sided|||Baseline and 24 weeks||||0.559
91782274|NCT00750438|183444211|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.062
91782275|NCT00750438|183444211|SUPERIORITY|||||||0.099|||||||Regression, Linear|||||||0.099
91782276|NCT00750438|183444212|SUPERIORITY|||||||0.036|||||||Regression, Linear|||||||0.036
91782277|NCT00750438|183444213|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.001
91782278|NCT00750438|183444213|SUPERIORITY|||||||0.723|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.723
91782279|NCT00750438|183444213|SUPERIORITY|||||||0.027|||||||Regression, Linear|||||||0.027
91782280|NCT00750438|183444214|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
91782281|NCT00750438|183444214|SUPERIORITY|||||||0.644|||||||t-test, 2 sided|||||||0.644
91782282|NCT00750438|183444214|SUPERIORITY|||||||0.549|||||||Regression, Linear|||||||0.549
91782283|NCT03848728|183444215|SUPERIORITY||Risk Ratio (RR)|1.1||||0.0019|TWO_SIDED|95.0|1.03|1.16|||TMLE|||||1.16|1.03|0.0019
91782284|NCT05475483|183444236|OTHER||Mean Difference (Final Values)|-1.27|||=|0.045|TWO_SIDED|95.0|-2.51|-0.03|||Mixed Models Analysis|||||-0.03|-2.51|= 0.045
91782285|NCT05475483|183444237|OTHER||Odds Ratio (OR)|2.22|||=|0.078|TWO_SIDED|95.0|0.91|5.37|||Regression, Logistic|||||5.37|0.91|= 0.078
91782286|NCT05475483|183444238|OTHER||Odds Ratio (OR)|1.95||||0.143|TWO_SIDED|95.0|0.8|4.76|||Regression, Logistic|||||4.76|0.80|0.143
91782287|NCT05475483|183444239|OTHER||Mean Difference (Final Values)|-1.78|||=|0.032|TWO_SIDED|95.0|-3.4|-0.16|||Mixed Models Analysis|||||-0.16|-3.40|= 0.032
91782288|NCT01499277|183444259|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations.|Risk Difference (RD)|-0.95|||||TWO_SIDED|95.0|-6.9|5.41||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||5.41|-6.9|
91790221|NCT00534313|183459760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.08||||||95.0|-4.79|8.96|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.96|-4.79|
91790222|NCT00534313|183459760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|||||TWO_SIDED|95.0|-4.94|8.95|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.95|-4.94|
91790223|NCT00534313|183459760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-6.08|7.58|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||7.58|-6.08|
91592007|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.3|1.74||||||B1: 60-64 years||1.74|1.30|
91782289|NCT01499277|183444260|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was \>0%.|Risk Difference (RD)|1.27|||||TWO_SIDED|95.0|-4.32|7.48||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||7.48|-4.32|
91782290|NCT01499277|183444261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.71|||||TWO_SIDED|95.0|-6.21|10.39||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||10.39|-6.21|
91782291|NCT01499277|183444262|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.77|||||TWO_SIDED|95.0|-2.11|12.86||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||12.86|-2.11|
91782292|NCT01499277|183444263|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.25|||||TWO_SIDED|95.0|-4.05|7.06||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||7.06|-4.05|
91782293|NCT01499277|183444264|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.92|||||TWO_SIDED|95.0|-2.19|8.73||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||8.73|-2.19|
91782294|NCT01499277|183444265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.79|||||TWO_SIDED|95.0|-3.98|1.18||||RD is the difference in relapse rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||1.18|-3.98|
91782295|NCT01499277|183444266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.86|||||TWO_SIDED|95.0|-6.34|3.15||||RD is the difference in success rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||3.15|-6.34|
91782296|NCT02974543|183444277|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91782297|NCT02974543|183444278|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91782298|NCT00220636|183444281|SUPERIORITY_OR_OTHER||t statistic|4.7|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.||||<.001
91782299|NCT00220636|183444283|SUPERIORITY_OR_OTHER||t statistic|-3.1||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.||||.009
91782300|NCT00220636|183444284|SUPERIORITY_OR_OTHER||t statistic|3.1||||0.008|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.||||.008
91782301|NCT02910986|183444303|SUPERIORITY||||||>|0.05|||||||Chi-squared|||The percentage with improved knowledge (defined as having an incorrect response at T0 and a correct response at T1) was compared between study groups with chi-square tests.||||> 0.05
91782302|NCT02910986|183444304|SUPERIORITY|||||||0.56||||||The priori threshold for statistical significance was 0.05|Chi-squared|||||||0.56
91782303|NCT02910986|183444305|SUPERIORITY||||||>|0.05||||||The priori threshold for statistical significance was 0.05.|Chi-squared|||||||> 0.05
91782304|NCT02910986|183444305|OTHER||difference between EC and UC|2.6|||||TWO_SIDED|98.3|-6.0|11.2||||||||11.2|-6.0|
91782305|NCT02910986|183444305|OTHER||difference between INT and UC|5.0|||||TWO_SIDED|98.3|-4.3|14.3||||||||14.3|-4.3|
91782306|NCT02910986|183444305|OTHER||difference between INT and ENH|2.4|||||TWO_SIDED|98.3|-7.0|11.9||||||||11.9|-7.0|
91782307|NCT03682770|183444326|SUPERIORITY||Difference in percentage|20.23||||0.042|TWO_SIDED|95.0|1.266|39.189||The p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by screening peanut-specific IgE level and baseline body weight.|Cochran-Mantel-Haenszel||Difference in percentage derived by Mantel-Haenszel (MH) method|||39.189|1.266|0.0420
91782308|NCT03682770|183444327|SUPERIORITY||Least Square Mean Difference|0.67||||0.04|TWO_SIDED|95.0|0.031|1.305||P-value is based on treatment difference (dupilumab + AR101 vs placebo + AR101) of the LS mean change using analysis of covariance (ANCOVA) model.|ANCOVA|||||1.305|0.031|0.0400
91782309|NCT03682770|183444328|SUPERIORITY||Difference in percentage|11.91||||0.0806|TWO_SIDED|95.0|-3.612|27.44||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kilo allergy unit per liter \[kUA/L\] vs \>100 kUA/L) and body weight (\<30 kg, \>=30 and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||27.440|-3.612|0.0806
91782310|NCT03682770|183444330|SUPERIORITY||Difference in percentage|10.4||||0.353|TWO_SIDED|95.0|-11.668|32.474||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||32.474|-11.668|0.3530
91782311|NCT03682770|183444331|SUPERIORITY||Least Square Mean Difference|0.37||||0.2628|TWO_SIDED|95.0|-0.281|1.029||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||1.029|-0.281|0.2628
91782312|NCT03682770|183444332|SUPERIORITY||Difference in percentage|-2.36||||0.814|TWO_SIDED|95.0|-25.004|20.282||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||20.282|-25.004|0.8140
91782313|NCT03682770|183444333|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8805|TWO_SIDED|95.0|-0.699|0.599||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||0.599|-0.699|0.8805
91782314|NCT03682770|183444335|SUPERIORITY||Difference percentage|-85.55|||<|0.0001|TWO_SIDED|95.0|-99.47|-73.91||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate,- and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-73.91|-99.47|<0.0001
91782315|NCT03682770|183444336|SUPERIORITY||Difference in percentage|-68.78|||<|0.0001|TWO_SIDED|95.0|-86.71|-56.4||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate, and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-56.40|-86.71|<0.0001
91782316|NCT02304367|183444352|OTHER|||||||0.0428|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in osteoid thickness is zero was tested using a t-test.||||0.0428
91782317|NCT02304367|183444353|OTHER|||||||0.977|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OS/BS is zero was tested using a t-test.||||0.9770
91782318|NCT02304367|183444354|OTHER|||||||0.0858|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OV/BV is zero was tested using a t-test.||||0.0858
91782319|NCT02304367|183444355|OTHER|||||||0.4077|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in Mlt is zero was tested using a t-test.||||0.4077
91782320|NCT02304367|183444362|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 24||||0.016
91782321|NCT02304367|183444362|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 48||||0.030
91782322|NCT02304367|183444362|OTHER|||||||0.259|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 96||||0.259
91782323|NCT02304367|183444362|OTHER|||||||0.346|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 144||||0.346
91782324|NCT02304367|183444362|OTHER|||||||0.213|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 168||||0.213
91782325|NCT02304367|183444362|OTHER|||||||0.873|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 192||||0.873
91782326|NCT02304367|183444362|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 216||||0.001
91782327|NCT02304367|183444362|OTHER|||||||0.04|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 240||||0.040
91592008|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.77|||||TWO_SIDED|95.0|1.53|2.04||||||B2: 60-64 years||2.04|1.53|
91592009|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.44|2.15||||||A/H1N1: \>=65 years||2.15|1.44|
91592010|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|2.15|||||TWO_SIDED|95.0|1.74|2.65||||||A/H3N2: \>=65 years||2.65|1.74|
91592011|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.55|||||TWO_SIDED|95.0|1.34|1.79||||||B1: \>=65 years||1.79|1.34|
91592012|NCT04024228|183074236|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.52|2.03||||||B2: \>=65 years||2.03|1.52|
91592013|NCT04490395|183074259|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.044|TWO_SIDED|95.0|-0.26|3.62|||t-test, 2 sided|||||3.62|-0.26|0.044
91592014|NCT04490395|183074260|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.056|TWO_SIDED|95.0|-0.15|1.33|||t-test, 2 sided|||||1.33|-0.15|0.056
91592015|NCT04490395|183074261|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.377|TWO_SIDED|95.0|-1.75|1.28|||t-test, 2 sided|||||1.28|-1.75|0.377
91592016|NCT04490395|183074262|SUPERIORITY|Within subjects change over time|F test (1,15) df|1.381||||0.258|TWO_SIDED||||||ANOVA|Change over time||Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.|Within subjects change over time.|||0.258
91592017|NCT04490395|183074262|SUPERIORITY|Between group analysis|F test (1,15) df|0.246||||0.627|TWO_SIDED||||||ANOVA||||Between group analysis|||0.627
91592018|NCT04490395|183074262|SUPERIORITY||F test (1,15) df|0.005||||0.947|TWO_SIDED||||||ANOVA|||Time x Condition interaction|Time x Condition interaction|||0.947
91592019|NCT04490395|183074263|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.038|TWO_SIDED|95.0|-1.85|0.98|||t-test, 2 sided|||||0.98|-1.85|0.038
91782328|NCT02304367|183444363|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 24||||<0.0001
91592020|NCT04490395|183074264|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.07|TWO_SIDED|95.0|-6.05|0.94|||t-test, 2 sided|||||0.94|-6.05|0.07
91592021|NCT04490395|183074265|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.43|TWO_SIDED|95.0|-1.19|1.42|||t-test, 2 sided|||||1.42|-1.19|0.43
91592022|NCT04490395|183074266|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.72|TWO_SIDED|95.0|-0.194|1.42|||t-test, 2 sided|||||1.42|-.194|0.72
91592023|NCT04490395|183074267|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.341|TWO_SIDED|95.0|-0.35|0.23|||t-test, 2 sided|||||0.23|-0.35|0.341
91782329|NCT02304367|183444363|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 48||||<0.0001
91592024|NCT04490395|183074268|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.25|TWO_SIDED|95.0|-2.35|1.17|||t-test, 2 sided|||||1.17|-2.35|0.25
91592025|NCT00938717|183074269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|2.44|8.84||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||8.84|2.44|<0.0001
91592026|NCT00938717|183074270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.03||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||7.03|2.50|<0.0001
91592027|NCT00938717|183074271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.91|3.6||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||3.60|1.91|<0.0001
91782330|NCT02304367|183444363|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 96||||0.001
91782331|NCT02304367|183444363|OTHER|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 144||||0.007
91782332|NCT02304367|183444363|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 168||||0.005
91782333|NCT02304367|183444363|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 192||||0.004
91782334|NCT02304367|183444363|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 216||||0.002
91521493|NCT03184792|182917465|SUPERIORITY||Median Difference (Final Values)|10.4||||0.01|TWO_SIDED|95.0|3.7|17.0|||t-test, 2 sided|||||17.0|3.7|0.010
91782335|NCT02304367|183444363|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 240||||0.006
91782336|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 24||||< 0.001
91782337|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 48||||< 0.001
91782338|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 96||||<0.001
91782339|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 144||||< 0.001
91782340|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 168||||< 0.001
91592028|NCT00938717|183074272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.22|4.49||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||4.49|2.22|<0.0001
91592029|NCT01180478|183074304|SUPERIORITY_OR_OTHER|||||||0.585|||||||Log Rank|||The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).||||0.585
91592030|NCT01180478|183074305|SUPERIORITY_OR_OTHER|||||||0.742|||||||Chi-squared|||||||0.742
91592031|NCT01180478|183074306|SUPERIORITY_OR_OTHER|||||||0.17|||||||Fisher Exact|The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.||The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.||||0.170
91592032|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.311|||||||Chi-squared|||Comparison of the numbers in 'Bleeding' between NBI and WL||||0.311
91592033|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.666|||||||Chi-squared|||Comparison of the numbers in 'Fever' between NBI and WL||||0.666
91592034|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|||Comparison in the number of 'UTI' between NBI and WL||||0.569
91592035|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.111|||||||Chi-squared|||Comparison in the number of 'Bladder cramps' between NBI and WL||||0.111
91592036|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'DVT' between NBI and WL|Non of the participants/patients had DVT. Therefore, the p-value is not available|||
91592037|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'CVA/TIA' between NBI and WL||||0.500
91592038|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'Lung embolism' between NBI and WL|Non of the participants/patients had a lung embolism. Therefore, no p-value was available|||
91592039|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'Sepsis' between NBI and WL||||0.500
91592040|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Comparison in the number of 'Acute Abdomen' between NBI and WL||||1.000
91592041|NCT01180478|183074307|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||Comparison in the number of 'Other perioperative complication' between NBI and WL||||0.170
91782341|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 192||||< 0.001
91592042|NCT01180478|183074308|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED||||||Chi-squared|||||||0.553
91592043|NCT02114164|183074388|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91782342|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 216||||< 0.001
91592044|NCT02114164|183074389|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
91592045|NCT02114164|183074390|OTHER|||||||0.13||||||Comparison at baseline|t-test, 2 sided|||||||0.13
91592046|NCT02114164|183074390|OTHER|||||||0.018||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.018
91592047|NCT02114164|183074390|OTHER|||||||0.712||||||Comparison at end of procedure|t-test, 2 sided|||||||0.712
91592048|NCT02114164|183074391|OTHER|||||||0.42||||||Comparison at baseline|t-test, 2 sided|||||||0.42
91592049|NCT02114164|183074391|OTHER|||||||0.75||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.75
91592050|NCT02114164|183074391|OTHER|||||||0.99||||||Comparison at end of procedure|t-test, 2 sided|||||||0.99
91592051|NCT02114164|183074392|OTHER|||||||0.88||||||Comparison at baseline|t-test, 2 sided|||||||0.88
91592052|NCT02114164|183074392|OTHER|||||||0.65||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.65
91592053|NCT02114164|183074392|OTHER|||||||0.86||||||Comparison at end of procedure|t-test, 2 sided|||||||0.86
91592054|NCT02114164|183074393|OTHER|Number of interventions required by the anesthesiologists were compared between the AirSeal and standard Endopath groups using zero-inflated Poisson regression||||||0.41|||||||Zero-inflated Poisson regression|||||||0.41
91592055|NCT02114164|183074394|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
91592056|NCT02114164|183074395|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91592057|NCT02573870|183074427|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p-values were not presented as non-inferiority was assessed by confidence interval (CI).|Mean Difference (Final Values)|-2.245|||||TWO_SIDED|95.0|-6.153|1.663|||||Treatment difference is calculated as active minus placebo and the non-inferiority bound was 10 bpm for Day 42|||1.663|-6.153|
91592058|NCT00257725|183074428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.09|STANDARD_DEVIATION|0.73||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
91592059|NCT00257725|183074429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.64|STANDARD_DEVIATION|1.29||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
91592060|NCT00257725|183074430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.55|STANDARD_DEVIATION|7.7||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
91592061|NCT01858532|183074431|OTHER||||||=|0.029|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.029
91782343|NCT02304367|183444364|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 240||||< 0.001
91782344|NCT02304367|183444365|OTHER|||||||0.659|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 24||||0.659
91782345|NCT02304367|183444365|OTHER|||||||0.752|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 48||||0.752
91782346|NCT02304367|183444365|OTHER|||||||0.594|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 96||||0.594
91592062|NCT01858532|183074431|OTHER||Hazard Ratio (HR)|0.654|||=|0.005|TWO_SIDED|95.0|0.488|0.878|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.878|0.488|=0.005
91592063|NCT01858532|183074432|OTHER||||||=|0.289|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.289
91592064|NCT01858532|183074432|OTHER||Hazard Ratio (HR)|0.779||||0.112|TWO_SIDED|95.0|0.573|1.06|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.060|0.573|0.112
91592065|NCT01858532|183074433|OTHER|||||||0.089|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.089
91521494|NCT03184792|182917466|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91592066|NCT01858532|183074433|OTHER||Hazard Ratio (HR)|0.801||||0.049|TWO_SIDED|95.0|0.642|0.999|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.999|0.642|0.049
91592067|NCT01858532|183074434|OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.89|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.89|0.58|0.002
91592068|NCT01858532|183074435|OTHER|||||||0.446|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.446
91592069|NCT01858532|183074435|OTHER||Hazard Ratio (HR)|0.884||||0.447|TWO_SIDED|95.0|0.643|1.215|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.215|0.643|0.447
91592070|NCT00514514|183074436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.56|||<|0.0001|TWO_SIDED|95.0|2.82|8.31|||ANCOVA|||||8.31|2.82|< 0.0001
91592071|NCT01480284|183074473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was judged based on the one-sided test of the model, y(Δ) = Baseline + Group ( Δ= -1.0). The adjusted mean values of the TDF group and the ETV group were calculated, and the adjusted mean value and two-sided 95% confidence interval of differences between the TDF group and the ETV group were calculated. Non-inferiority was also to be confirmed when the upper limit of the calculated two-sided 95% confidence interval was less than the non-inferiority limit value of 1.0|Mean Difference (Final Values)|-0.13|||<|0.0001|TWO_SIDED|95.0|-0.28|0.02||p-value was compared with the significance level of 0.025|ANCOVA|||||0.02|-0.28|<0.0001
91592072|NCT01480284|183074474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.4|0.39|||||CI and estimate difference is provided for change from Baseline in serum HBV DNA level at Week 48.|||0.39|-0.40|
91592073|NCT04746833|183074485|EQUIVALENCE|mean of Summit will be equal to mean of control||||||0.91|||||||t-test, 2 sided|||||||.91
91592074|NCT04746833|183074486|OTHER|||||||||||||||||descriptive statistic of system use|simple descriptive findings for evaluation of feasibility of the Sumit app|||
91592075|NCT04746833|183074487|EQUIVALENCE|standard null hypothesis of no difference between groups||||||0.5|||||||t-test, 2 sided|||||||.50
91592076|NCT04013789|183074499|NON_INFERIORITY|The noninferiority margin was set at 0.05.|Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.03|||Mixed Effects Repeated Measures Model||DACP FreshTech minus DACP|||0.03||
91592077|NCT01488279|183074501|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|480.8||0.983|TWO_SIDED|95.0|-1147.6|1126.0|||ANOVA|||2X2 crossover design with baseline values. To compare the means between Sitagliptin and Placebo, a sequential three step testing process used. The results of the third step, the direct treatment comparisons are presented.||1126.0|-1147.6|.983
91592078|NCT01488279|183074504|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|1.935||0.997|TWO_SIDED|95.0|-4.585|4.568|||ANOVA|||||4.568|-4.585|.997
91592079|NCT01488279|183074505|SUPERIORITY||Mean Difference (Net)|-38.9|STANDARD_ERROR_OF_MEAN|49.9||0.46|TWO_SIDED|95.0|-156.9|79.0|||ANOVA|||||79.0|-156.9|.460
91592080|NCT03593850|183074506|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
91592081|NCT03593850|183074507|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.392|||||||t-test, 2 sided|||||||0.392
91592082|NCT03593850|183074508|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.802|||||||t-test, 2 sided|||||||0.802
91592083|NCT03593850|183074509|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91782347|NCT02304367|183444365|OTHER|||||||0.614|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 144||||0.614
91592084|NCT03593850|183074509|SUPERIORITY||Adjusted mean difference|1.429||||0.006|TWO_SIDED||||||ANCOVA|Fixed factors: group, covariates: pain before (VAS2), age in years, age at menarche, duration of menses, usual pain, anxiety before, hours with pain.|||Adjusted means: music 3.131 (99% CI 2.62, 3.999) and silence 4.56 (99% CI 3.581, 5.538), F= 8.44, R-square 54.5%|||0.006
91592085|NCT03593850|183074510|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91592086|NCT03593850|183074510|SUPERIORITY||Adjusted mean difference|0.721||||0.37|TWO_SIDED||||||ANCOVA|Fixed factor: Groups Covariates: Pain before, pain after, age, age menarche, menses duration, usual pain, anxiety before, anxiety after, hours pain|Adjusted means: music 2.58 (99% CI 1.339, 3.829), and silence 3.305 (1.728, 4.881); F 0.827, R-square 27.2%|||||0.370
91592087|NCT03593850|183074511|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.377|||||||t-test, 2 sided|||||||0.377
91592088|NCT03593850|183074512|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||0.049
91592089|NCT03593850|183074513|SUPERIORITY|||||||0.168|||||||t-test, 2 sided|||||||0.168
91592090|NCT03593850|183074514|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.642|||||||Chi-squared|||||||0.642
91592091|NCT03593850|183074515|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
91592092|NCT03593850|183074516|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
91592093|NCT03593850|183074517|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.307|||||||t-test, 2 sided|||||||0.307
91592094|NCT03593850|183074518|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.318|||||||t-test, 2 sided|||||||0.318
91592095|NCT03593850|183074519|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.954|||||||t-test, 2 sided|||||||0.954
91782348|NCT02304367|183444365|OTHER|||||||0.542|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 168||||0.542
91782349|NCT02304367|183444365|OTHER|||||||0.067|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 192||||0.067
91782350|NCT02304367|183444365|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 216||||0.330
91782351|NCT02304367|183444365|SUPERIORITY|||||||0.161|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 240||||0.161
91782352|NCT02304367|183444366|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 24||||< 0.001
91782353|NCT02304367|183444366|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 48||||< 0.001
91782354|NCT02304367|183444366|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 96||||0.001
91782355|NCT02304367|183444366|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 144||||< 0.001
91782356|NCT02304367|183444366|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 168||||< 0.001
91782357|NCT02304367|183444366|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 192||||< 0.001
91782358|NCT02304367|183444366|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 216||||< 0.001
91782359|NCT02304367|183444366|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 240||||< 0.001
91782360|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 24||||< 0.001
91782361|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 48||||< 0.001
91782362|NCT02304367|183444367|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 96||||0.002
91782363|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 144||||< 0.001
91782364|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 168||||< 0.001
91782365|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 192||||< 0.001
91782366|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 216||||< 0.001
91782367|NCT02304367|183444367|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 240||||< 0.001
91782368|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 24||||< 0.001
91782369|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 48||||< 0.001
91782370|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 96||||< 0.001
91782371|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 144||||< 0.001
91592096|NCT03593850|183074520|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.258|||||||t-test, 2 sided|||||||0.258
91592097|NCT03593850|183074521|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
91782372|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 168||||< 0.001
91782373|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 192||||< 0.001
91782374|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 216||||< 0.001
91782375|NCT02304367|183444368|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 240||||< 0.001
91782376|NCT02304367|183444369|OTHER|||||||0.878|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 24||||0.878
91782377|NCT02304367|183444369|OTHER|||||||0.081|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 48||||0.081
91782378|NCT02304367|183444369|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 96||||0.001
91782379|NCT02304367|183444369|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 144||||< 0.001
91782380|NCT02304367|183444369|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 168||||< 0.001
91782381|NCT02304367|183444369|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 192||||< 0.001
91782382|NCT02304367|183444369|OTHER|||||||0.055|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 216||||0.055
91782383|NCT02304367|183444369|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 240||||0.041
91782384|NCT02304367|183444370|OTHER|||||||0.817|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.817
91782385|NCT02304367|183444370|OTHER|||||||0.042|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.042
91782386|NCT02304367|183444370|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
91782387|NCT02304367|183444370|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
91521495|NCT00313820|182917472|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.578||95.0|-0.7|0.4|||ANCOVA|ANCOVA with treatment and country as factors and baseline pain score as covariate.||Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo||0.4|-0.7|0.578
91592098|NCT03593850|183074522|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||||||0.056
91592099|NCT03593850|183074523|SUPERIORITY|||||||0.885|||||||t-test, 2 sided|||||||0.885
91782388|NCT02304367|183444370|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
91782389|NCT02304367|183444370|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
91782390|NCT02304367|183444370|OTHER|||||||0.174|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.174
91782391|NCT02304367|183444370|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
91782392|NCT02304367|183444371|OTHER|||||||0.694|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.694
91782393|NCT02304367|183444371|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.047
91782394|NCT02304367|183444371|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
91782395|NCT02304367|183444371|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
91782396|NCT02304367|183444371|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
91782397|NCT02304367|183444371|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
91782398|NCT02304367|183444371|OTHER|||||||0.17|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.170
91782399|NCT02304367|183444371|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
91782400|NCT02304367|183444372|OTHER|||||||0.09|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.090
91782401|NCT02304367|183444372|OTHER|||||||0.226|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.226
91782402|NCT02304367|183444372|OTHER|||||||0.918|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.918
91782403|NCT02304367|183444372|OTHER|||||||0.616|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.616
91782404|NCT02304367|183444372|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.041
91592100|NCT03593850|183074524|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
91592101|NCT00119041|183074548|SUPERIORITY_OR_OTHER||||||>|0.153|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|||Comparisons were made between the intervention and control groups at baseline||||>0.153
91592102|NCT00119041|183074548|SUPERIORITY_OR_OTHER||||||>|0.25|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.||Comparisons were made between the intervention and control groups at 18 months||||>0.25
91592103|NCT04784897|183074554|SUPERIORITY||Cox Proportional Hazard|0.9289||||0.7273|TWO_SIDED|90.0|0.6585|1.3102|||Log Rank|||Main comparison is between Brilacidin 5-dose and Pooled Placebo||1.3102|0.6585|0.7273
91592104|NCT04784897|183074554|SUPERIORITY||Cox Proportional Hazard|0.8968||||0.5975|TWO_SIDED|90.0|0.5464|1.472|||Log Rank|||Secondary comparison between Brilacidin 3-dose and Pooled Placebo||1.4720|0.5464|0.5975
91592105|NCT02319668|183074573|SUPERIORITY_OR_OTHER||Least square (LS) Mean difference|0.2||||0.2965|TWO_SIDED|95.0|-0.18|0.58|||ANCOVA|ANCOVA with treatment as factor and baseline as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.58|-0.18|0.2965
91592106|NCT00365456|183074589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.012|STANDARD_ERROR_OF_MEAN|1.0045||0.01|TWO_SIDED|95.0|1.003|1.021||No multiplicity correction of the significance level was performed as only one primary endpoint was planned.|ANCOVA|Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.||An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.||1.021|1.003|0.010
91592107|NCT01846728|183074590|OTHER|||||||0.84||||||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|t-test, 2 sided|||||||0.84
91592108|NCT01846728|183074591|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
91592109|NCT01846728|183074592|OTHER|Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||||0.92|||||||t-test, 2 sided|||||||0.92
91592110|NCT01846728|183074593|OTHER|||||||0.98|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.98
91782405|NCT02304367|183444372|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.002
91592111|NCT01846728|183074594|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
91782406|NCT02304367|183444372|OTHER|||||||0.137|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.137
91592112|NCT04754802|183074602|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.42||0.5063|TWO_SIDED|95.0|-3.2|6.4|||ANCOVA|||||6.4|-3.2|.5063
91592113|NCT04754802|183074603|SUPERIORITY||Other|-0.015||||0.8077|TWO_SIDED|95.0|-0.137|0.107|||Wald Normal Approximation (Z)|Wald Normal Approximation (Z) for difference between two proportions||||0.107|-0.137|.8077
91592114|NCT00701090|183074604|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%, i.e., Sitagliptin was declared non-inferior to glimepiride if the upper limit of the two-sided 95% confidence interval for the between group difference (sitagliptin minus glimepiride) was less than 0.4%|Mean Difference (Net)|0.07|STANDARD_DEVIATION|0.7|||TWO_SIDED|95.0|-0.03|0.16|||||ANCOVA model with terms: treatment, country, and baseline HbA1c.|||0.16|-0.03|
91592115|NCT00701090|183074605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_DEVIATION|28.8|||TWO_SIDED|95.0|-0.9|6.7|||||ANCOVA model terms: treatment, country, and baseline.|||6.7|-0.9|
91782407|NCT02304367|183444372|OTHER|||||||0.368|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.368
91782408|NCT02304367|183444373|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.018
91782409|NCT02304367|183444373|OTHER|||||||0.133|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.133
91592116|NCT00701090|183074606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||Miettinen &Nurminen method||Miettinen \&Nurminen method was used for the 95% confidence interval|||-10.9|-19.3|<0.001
91592117|NCT00701090|183074607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|2.9|<|0.001|TWO_SIDED|95.0|-2.3|-1.6|||ANCOVA|Model terms: treatment, country, and baseline.|ANCOVA model terms: treatment, country, and baseline.|||-1.6|-2.3|<0.001
91592118|NCT00701090|183074608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.47|0.9|||||The parameter estimate and 95% CI represent the odds of having A1C \<7.0% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.90|0.47|
91592119|NCT00701090|183074609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.47|0.95|||||The parameter estimate and 95% CI represent the odds of having A1C \<6.5% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.95|0.47|
91592120|NCT00324753|183074610|SUPERIORITY|||||||0.005||||||p-value based on a test of any treatment difference by site.|Mixed Models Analysis|The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.||||||.005
91592121|NCT01299376|183074615|SUPERIORITY_OR_OTHER||Difference in Least-squares Means|-5.9|||<|0.001|TWO_SIDED|95.0|-7.5|-4.2|||Contrained Longitudinal Data Analysis|Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.||||-4.2|-7.5|<0.001
91521496|NCT00313820|182917472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294||95.0||||Interaction p-value based on adding interaction term to the main model.|ANCOVA|||Modelled Results: Treatment by country interaction||||0.294
91782410|NCT02304367|183444373|OTHER|||||||0.321|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.321
91782411|NCT02304367|183444373|OTHER|||||||0.218|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.218
91782412|NCT02304367|183444373|OTHER|||||||0.788|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.788
91782413|NCT02304367|183444373|OTHER|||||||0.156|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.156
91782414|NCT02304367|183444373|OTHER|||||||0.155|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.155
91782415|NCT02304367|183444373|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.580
91782416|NCT02304367|183444374|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.002
91782417|NCT02304367|183444374|OTHER|||||||0.273|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.273
91782418|NCT02304367|183444374|OTHER|||||||0.469|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.469
91782419|NCT02304367|183444374|OTHER|||||||0.828|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.828
91782420|NCT02304367|183444374|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||< 0.001
91782421|NCT02304367|183444374|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.141
91782422|NCT02304367|183444374|OTHER|||||||0.606|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.606
91782423|NCT02304367|183444374|OTHER|||||||0.907|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.907
91782424|NCT02304367|183444375|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.001
91782425|NCT02304367|183444375|OTHER|||||||0.149|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.149
91782426|NCT02304367|183444375|OTHER|||||||0.372|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.372
91782427|NCT02304367|183444375|OTHER|||||||0.116|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.116
91782428|NCT02304367|183444375|OTHER|||||||0.013|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||0.013
91782429|NCT02304367|183444375|OTHER|||||||0.962|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.962
91782430|NCT02304367|183444375|OTHER|||||||0.664|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.664
91782431|NCT02304367|183444375|OTHER|||||||0.79|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.790
91782432|NCT02304367|183444376|OTHER|||||||0.05|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||0.050
91782433|NCT02304367|183444376|OTHER|||||||0.526|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.526
91592122|NCT01299376|183074626|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3|||<|0.001|TWO_SIDED|95.0|-12.8|-7.7||Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|Constrained Longitudinal Data Analysis|||||-7.7|-12.8|<0.001
91592123|NCT00617604|183074628|SUPERIORITY_OR_OTHER||Difference|3.9|||||TWO_SIDED|90.0|-2.5|10.3||||||||10.3|-2.5|
91592124|NCT00617604|183074629|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-3.1|5.0||||||||5.0|-3.1|
91592125|NCT00617604|183074630|SUPERIORITY_OR_OTHER||Difference|3.0|||||TWO_SIDED|90.0|-4.0|10.1||||||||10.1|-4.0|
91592126|NCT00617604|183074631|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-0.6|2.5||||||||2.5|-0.6|
91592127|NCT00617604|183074632|SUPERIORITY_OR_OTHER||Difference|-5.1|||||TWO_SIDED|90.0|-14.9|4.7||||||||4.7|-14.9|
91592128|NCT00617604|183074633|SUPERIORITY_OR_OTHER||Difference|-9.4|||||TWO_SIDED|90.0|-18.5|0.0||||||||0.0|-18.5|
91592129|NCT00617604|183074634|SUPERIORITY_OR_OTHER||Difference|-1.9|||||TWO_SIDED|90.0|-7.6|3.8||||||||3.8|-7.6|
91592130|NCT00617604|183074635|SUPERIORITY_OR_OTHER||Difference|-1.8|||||TWO_SIDED|90.0|-8.2|4.6||||||||4.6|-8.2|
91592131|NCT00617604|183074636|SUPERIORITY_OR_OTHER||Difference|1.9|||||TWO_SIDED|90.0|-1.3|5.0||||||||5.0|-1.3|
91592132|NCT00617604|183074637|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-1.2|10.4||||||||10.4|-1.2|
91592133|NCT00617604|183074639|SUPERIORITY_OR_OTHER||Difference|2.0|||||TWO_SIDED|90.0|-3.3|7.2||||||||7.2|-3.3|
91592134|NCT00617604|183074644|SUPERIORITY_OR_OTHER||Slope|6.0|||||TWO_SIDED|90.0|-2.7|14.6||||||||14.6|-2.7|
91592135|NCT00617604|183074645|SUPERIORITY_OR_OTHER||Difference|-4.5|||||TWO_SIDED|90.0|-11.2|2.2||||||||2.2|-11.2|
91592136|NCT00617604|183074646|SUPERIORITY_OR_OTHER||Difference|5.2|||||TWO_SIDED|90.0|-4.4|14.7||||||||14.7|-4.4|
91592137|NCT04029961|183074655|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
91592138|NCT04029961|183074656|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
91592139|NCT04029961|183074657|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
91592140|NCT04029961|183074658|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
91613930|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.444||||0.0056|TWO_SIDED|95.0|1.547|12.766|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.766|1.547|0.0056
91592141|NCT04029961|183074659|OTHER|"A univariate analysis comparing the proportion of each arm that indicated an item was met, evaluated for each item at each time point."|||||<|0.05|||||||Univariate analysis|||"The statistical test described below was only performed on the top 10 items on the scale rated the highest in importance by participants. The top 10 items were determined by computing the mean rating for each item (participants gave each item a rating from '1' - '9' with higher values representing greater importance) and selecting the 10 items with the largest mean values, excluding the item the radiation oncologist who will be treating me as that item was not addressed in either intervention."||||<0.05
91592142|NCT03086265|183074660|OTHER|||||||0.7934|||||||t-test, 2 sided|||||||0.7934
91592143|NCT03086265|183074669|OTHER|||||||0.6876|||||||t-test, 2 sided|||||||0.6876
91592144|NCT03086265|183074670|OTHER|||||||0.7549|||||||t-test, 2 sided|||||||0.7549
91592145|NCT03086265|183074671|OTHER|||||||0.6479|||||||t-test, 2 sided|||||||0.6479
91592146|NCT03086265|183074672|OTHER|||||||0.8322|||||||t-test, 2 sided|||||||0.8322
91592147|NCT03086265|183074674|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
91592148|NCT03086265|183074675|OTHER|||||||0.3346|||||||t-test, 2 sided|||||||0.3346
91592149|NCT03086265|183074676|OTHER|||||||0.5513|||||||t-test, 2 sided|||||||0.5513
91592150|NCT03086265|183074677|OTHER|||||||0.1927|||||||t-test, 2 sided|||||||0.1927
91592151|NCT03086265|183074678|OTHER|||||||0.6483|||||||t-test, 2 sided|||||||0.6483
91592152|NCT03086265|183074679|OTHER|||||||0.5625|||||||t-test, 2 sided|||||||0.5625
91782434|NCT02304367|183444376|OTHER|||||||0.845|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.845
91782435|NCT02304367|183444376|OTHER|||||||0.782|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.782
91592153|NCT03086265|183074680|OTHER|||||||0.2827|||||||t-test, 2 sided|||||||0.2827
91592154|NCT03086265|183074681|OTHER|||||||0.8426|||||||t-test, 2 sided|||||||0.8426
91592155|NCT03086265|183074682|OTHER|||||||0.9856|||||||t-test, 2 sided|||||||0.9856
91592156|NCT03086265|183074683|OTHER|||||||0.8112|||||||t-test, 2 sided|||||||0.8112
91592157|NCT03086265|183074684|OTHER|||||||0.6587|||||||t-test, 2 sided|||||||0.6587
91592158|NCT03086265|183074685|OTHER|||||||0.4143|||||||t-test, 2 sided|||||||0.4143
91592159|NCT03086265|183074686|OTHER|||||||0.4324|||||||t-test, 2 sided|||||||0.4324
91592160|NCT03086265|183074687|OTHER|||||||0.7221|||||||t-test, 2 sided|||Comparison of preoperative scores.||||0.7221
91592161|NCT03086265|183074687|OTHER|||||||0.0336|||||||t-test, 2 sided|||Comparison of postoperative scores.||||0.0336
91592162|NCT02347488|183074691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|2.88|3.32|||ANCOVA|||Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures.||3.32|2.88|<0.001
91592163|NCT00688155|183074695|EQUIVALENCE|Two-sided test of mean differences from baseline.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|||||Physical activity training versus no physical activity training;|ANOVA|||Marginal comparisons of physical activity training vs no physical activity training||||0.66
91592164|NCT00688155|183074695|EQUIVALENCE|Two-sided tests of mean differences from baseline.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.26||0.55|TWO_SIDED|||||P-value for physical activity training is 0.55|ANOVA|||Marginal comparisons of physical activity training versus no physical activity training||||0.55
91592165|NCT00688155|183074695|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.25||0.95|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.95
91592166|NCT00688155|183074695|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.26||0.48|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.48
91592167|NCT00688155|183074697|EQUIVALENCE|Two-sided tests of marginal means|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.23|TWO_SIDED||||||ANOVA|||Marginal comparisons of physical activity training versus no physical activity training.||||0.23
91592168|NCT00688155|183074697|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.42|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.42
91782436|NCT02304367|183444376|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.020
91782437|NCT02304367|183444376|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.005
91782438|NCT02304367|183444376|OTHER|||||||0.136|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 216||||0.136
91592169|NCT00445224|183074712|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||.041
91592170|NCT00445224|183074713|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||Repeated measures ANOVA for group and time||||.049
91592171|NCT04391036|183074714|SUPERIORITY||||||>|0.99|||||||McNemar|||This was a paired analysis comparing successful insertion of the high and low Eudragit® Films. The McNemar's test statistic is based on the discordant pairs (number of participants with high successful, low unsuccessful versus low successful, high unsuccessful).||||>.99
91592172|NCT04391036|183074715|SUPERIORITY|||||||0.45||||||This was a paired analysis comparing difficulty of insertion of the high and low Eudragit® Films. The McNemar's test is based on discordant pairs (high was not difficult, low was difficult versus low was not difficult, high was difficult).|McNemar|||||||.45
91592173|NCT04391036|183074716|SUPERIORITY|||||||0.26|||||||Fisher Exact|This was an overall Fisher's exact test so the analysis applies to all categories.||||||.26
91592174|NCT03184077|183074717|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
91592175|NCT03184077|183074718|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
91592176|NCT03184077|183074719|SUPERIORITY|||||||0.01||||||This is a calculated p value|Chi-squared|||||||0.01
91592177|NCT04136184|183074720|SUPERIORITY||Difference in LS Mean|-24.7593||||1e-08|TWO_SIDED|95.0|-30.9552|-18.5635|||MMRM|||||-18.5635|-30.9552|0.00000001
91592178|NCT04136184|183074721|SUPERIORITY||Difference in LS Mean|-19.7352||||1e-08|TWO_SIDED|95.0|-25.6301|-13.8403|||MMRM|||||-13.8403|-25.6301|0.00000001
91592179|NCT04136184|183074722|SUPERIORITY||Difference in LS Mean|-70.42||||1e-08|TWO_SIDED|95.0|-75.17|-65.66|||MMRM|||||-65.66|-75.17|0.00000001
91592180|NCT04136184|183074723|SUPERIORITY||Difference in LS Mean|-66.65||||1e-08|TWO_SIDED|95.0|-71.59|-61.71|||MMRM|||||-61.71|-71.59|0.00000001
91592181|NCT04136184|183074724|SUPERIORITY||Difference in LS Mean|-9.3542||||0.00012203|TWO_SIDED|95.0|-13.8691|-4.8394|||MMRM|||||-4.8394|-13.8691|0.00012203
91592182|NCT04136184|183074725|SUPERIORITY||Difference in LS Mean|-11.8202||||1.873e-05|TWO_SIDED|95.0|-16.8927|-6.7477|||MMRM|||||-6.7477|-16.8927|0.00001873
91592183|NCT04136184|183074726|SUPERIORITY||Difference in LS Mean|-3.94||||0.00052447|TWO_SIDED|95.0|-6.08|-1.8|||MMRM|||Week 35||-1.80|-6.08|0.00052447
91592184|NCT04136184|183074726|SUPERIORITY||Difference in LS Mean|-8.21||||1e-08|TWO_SIDED|95.0|-10.65|-5.76|||MMRM|||Week 66||-5.76|-10.65|0.00000001
91592185|NCT04136184|183074727|SUPERIORITY||Difference in LS Mean|5.305||||5.58e-06|TWO_SIDED|95.0|3.195|7.416|||MMRM|||||7.416|3.195|0.00000558
91592186|NCT04136184|183074728|SUPERIORITY||Difference in LS Mean|-0.2||||0.02407897|TWO_SIDED|95.0|-0.4|0.0|||MMRM|||||-0.0|-0.4|0.02407897
91592187|NCT04136184|183074729|SUPERIORITY||Difference in LS Mean|82.6991||||2e-07|TWO_SIDED|95.0|54.6431|110.7551|||MMRM|||||110.7551|54.6431|0.00000020
91592188|NCT05314712|183074746|OTHER|Linear Mixed Model (repeated measures model) of sleep trouble||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. Under the assumption that the likert scale data was treated as continuous, the data was analyzed using a linear mixed model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final sleep trouble model included the covariates timing of survey, DASS scale, and indicator variable if child played outside.|||
91592189|NCT05314712|183074746|OTHER|Mixed effects linear regression model of hours slept||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. The data was analyzed using a mixed effects linear regression model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final model for hours slept included the covariates number of children in the household, indicator variable if child played outside, and baseline hours slept.|||
91592190|NCT04096274|183074834|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
91592191|NCT04096274|183074835|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
91592192|NCT04096274|183074836|SUPERIORITY|||||||0.188|||||||Mixed Models Analysis|||||||.188
91592193|NCT04096274|183074837|SUPERIORITY|||||||0.782|||||||Mixed Models Analysis|||||||.782
91592194|NCT01462435|183074839|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|446.946|STANDARD_ERROR_OF_MEAN|122.2935|<|0.001|TWO_SIDED|95.0|206.567|687.324|||ANCOVA|||||687.324|206.567|<0.001
91592195|NCT01462435|183074839|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|316.145|STANDARD_ERROR_OF_MEAN|121.5971||0.01|TWO_SIDED|95.0|77.136|555.155|||ANCOVA|||||555.155|77.136|0.010
91592196|NCT01462435|183074839|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|313.119|STANDARD_ERROR_OF_MEAN|122.5676||0.011|TWO_SIDED|95.0|72.202|554.037|||ANCOVA|||||554.037|72.202|0.011
91592197|NCT01462435|183074840|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||t-test, 2 sided|||||||0.043
91592198|NCT01462435|183074840|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||||||0.109
91592199|NCT01462435|183074840|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||t-test, 2 sided|||||||0.183
91592200|NCT01462435|183074841|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
91592201|NCT01462435|183074841|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
91592202|NCT01462435|183074841|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.050
91592203|NCT01462435|183074842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91782439|NCT02304367|183444376|OTHER|||||||0.101|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.101
91592204|NCT01462435|183074842|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91592205|NCT01462435|183074842|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91592206|NCT01462435|183074843|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
91592207|NCT01462435|183074843|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||||||0.091
91592208|NCT01462435|183074843|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||t-test, 2 sided|||||||0.053
91592209|NCT01462435|183074844|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
91592210|NCT01462435|183074844|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
91592211|NCT01462435|183074844|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
91592212|NCT01462435|183074845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91592213|NCT01462435|183074845|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
91592214|NCT01462435|183074845|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91592215|NCT01462435|183074846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91592216|NCT01462435|183074846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91592217|NCT01462435|183074846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91592218|NCT02248259|183074855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.522|128.376|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.376|100.522|
91592219|NCT02248259|183074855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.98|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.839|99.452|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.452|77.839|
91592220|NCT02248259|183074855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.21|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.636|94.021|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||94.021|84.636|
91592221|NCT02248259|183074855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.89|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.592|97.396|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis of CD 13896||97.396|88.592|
91592222|NCT02248259|183074855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.796|103.584|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.584|95.796|
91592223|NCT02248259|183074855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.37|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.783|110.278|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.278|98.783|
91592224|NCT02248259|183074856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|93.26|STANDARD_ERROR_OF_MEAN|1.086|||TWO_SIDED|90.0|80.377|108.217|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||108.217|80.377|
91782440|NCT02304367|183444377|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||< 0.001
91782441|NCT02304367|183444377|OTHER|||||||0.238|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.238
91782442|NCT02304367|183444377|OTHER|||||||0.286|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.286
91592225|NCT02248259|183074856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|76.65|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|60.482|97.141|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||97.141|60.482|
91592226|NCT02248259|183074856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|78.71|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|67.304|92.052|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||92.052|67.304|
91592227|NCT02248259|183074856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|95.29|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|81.092|111.964|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||111.964|81.092|
91592228|NCT02248259|183074856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|86.79|STANDARD_ERROR_OF_MEAN|1.041|||TWO_SIDED|90.0|80.731|93.309|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||93.309|80.731|
91592229|NCT02248259|183074856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|107.45|STANDARD_ERROR_OF_MEAN|1.091|||TWO_SIDED|90.0|91.764|125.812|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||125.812|91.764|
91592230|NCT02248259|183074857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.61|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.505|128.427|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.427|100.505|
91592231|NCT02248259|183074857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.91|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.763|99.37|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.370|77.763|
91592232|NCT02248259|183074857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.05|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.478|93.859|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||93.859|84.478|
91592233|NCT02248259|183074857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.48|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.278|96.889|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||96.889|88.278|
91592234|NCT02248259|183074857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.791|103.583|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.583|95.791|
91592235|NCT02248259|183074857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.44|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.861|110.336|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.336|98.861|
91592236|NCT01901575|183074875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.65|STANDARD_ERROR_OF_MEAN|0.75||0.05|TWO_SIDED|0.15|0.65|0.8|||Fisher Exact|||"null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's"||0.8|0.65|0.05
91592237|NCT00496730|183074900|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91592238|NCT00496730|183074901|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91592239|NCT00496730|183074902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91592240|NCT03962738|183074913|SUPERIORITY||Odds Ratio (OR)|3.46|||<|0.001|TWO_SIDED|95.0|2.17|5.54|||Regression, Logistic|||||5.54|2.17|<0.001
91592241|NCT03962738|183074914|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Trend Test|||||||<.001
91592242|NCT03962738|183074915|SUPERIORITY||Odds Ratio (OR)|1.76||||0.037|TWO_SIDED|95.0|1.03|2.99|||Regression, Logistic|||||2.99|1.03|0.037
91592243|NCT03962738|183074915|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.16|5.17|||Regression, Logistic|||||5.17|2.16|<0.001
91592244|NCT03962738|183074915|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.89|4.62|||Regression, Logistic|||||4.62|1.89|<0.001
91592245|NCT03962738|183074916|SUPERIORITY||Odds Ratio (OR)|1.49||||0.197|TWO_SIDED|95.0|0.81|2.72|||Regression, Logistic|||||2.72|0.81|0.197
91592246|NCT03962738|183074916|SUPERIORITY||Odds Ratio (OR)|1.59||||0.044|TWO_SIDED|95.0|1.01|2.5|||Regression, Logistic|||||2.50|1.01|0.044
91592247|NCT03962738|183074916|SUPERIORITY||Odds Ratio (OR)|1.75||||0.023|TWO_SIDED|95.0|1.08|2.83|||Regression, Logistic|||||2.83|1.08|0.023
91592248|NCT03962738|183074917|SUPERIORITY||Odds Ratio (OR)|1.52||||0.268|TWO_SIDED|95.0|0.73|3.17|||Regression, Logistic|||||3.17|0.73|0.268
91592249|NCT03962738|183074917|SUPERIORITY||Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.26|3.82|||Regression, Logistic|||||3.82|1.26|0.006
91592250|NCT03962738|183074917|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.5|4.61|||Regression, Logistic|||||4.61|1.50|<0.001
91592251|NCT03962738|183074918|SUPERIORITY||Odds Ratio (OR)|1.26||||0.535|TWO_SIDED|95.0|0.61|2.58|||Regression, Logistic|||||2.58|0.61|0.535
91592252|NCT03962738|183074918|SUPERIORITY||Odds Ratio (OR)|1.77||||0.036|TWO_SIDED|95.0|1.04|3.03|||Regression, Logistic|||||3.03|1.04|0.036
91592253|NCT03962738|183074918|SUPERIORITY||Odds Ratio (OR)|1.93||||0.018|TWO_SIDED|95.0|1.12|3.33|||Regression, Logistic|||||3.33|1.12|0.018
91592254|NCT03962738|183074919|SUPERIORITY||Odds Ratio (OR)|1.67||||0.199|TWO_SIDED|95.0|0.76|3.65|||Regression, Logistic|||||3.65|0.76|0.199
91592255|NCT03962738|183074919|SUPERIORITY||Odds Ratio (OR)|1.33||||0.305|TWO_SIDED|95.0|0.77|2.32|||Regression, Logistic|||||2.32|0.77|0.305
91592256|NCT03962738|183074919|SUPERIORITY||Odds Ratio (OR)|1.26||||0.426|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|||||2.24|0.71|0.426
91592257|NCT03962738|183074920|SUPERIORITY||Odds Ratio (OR)|1.57||||0.135|TWO_SIDED|95.0|0.87|2.82|||Regression, Logistic|||||2.82|0.87|0.135
91592258|NCT03962738|183074920|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.3|||Regression, Logistic|||||2.30|0.95|0.080
91592259|NCT03962738|183074920|SUPERIORITY||Odds Ratio (OR)|1.56||||0.061|TWO_SIDED|95.0|0.98|2.49|||Regression, Logistic|||||2.49|0.98|0.061
91521497|NCT00313820|182917473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.161||95.0|-0.8|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1 Modelled Results||0.1|-0.8|0.161
91592260|NCT03962738|183074921|SUPERIORITY||Odds Ratio (OR)|1.38||||0.342|TWO_SIDED|95.0|0.71|2.67|||Regression, Logistic|||||2.67|0.71|0.342
91592261|NCT03962738|183074921|SUPERIORITY||Odds Ratio (OR)|1.25||||0.377|TWO_SIDED|95.0|0.76|2.04|||Regression, Logistic|||||2.04|0.76|0.377
91592262|NCT03962738|183074921|SUPERIORITY||Odds Ratio (OR)|1.05||||0.862|TWO_SIDED|95.0|0.63|1.72|||Regression, Logistic|||||1.72|0.63|0.862
91592263|NCT03962738|183074923|SUPERIORITY||Odds Ratio (OR)|3.43||||0.112|TWO_SIDED|95.0|0.75|15.65|||Regression, Logistic|||||15.65|0.75|0.112
91592264|NCT03962738|183074923|SUPERIORITY||Odds Ratio (OR)|9.05|||<|0.001|TWO_SIDED|95.0|2.68|30.55|||Regression, Logistic|||||30.55|2.68|<0.001
91592265|NCT03962738|183074923|SUPERIORITY||Odds Ratio (OR)|10.19|||<|0.001|TWO_SIDED|95.0|3.01|34.55|||Regression, Logistic|||||34.55|3.01|<0.001
91592266|NCT03962738|183074924|SUPERIORITY||Odds Ratio (OR)|0.78||||0.343|TWO_SIDED|95.0|0.46|1.31|||Regression, Logistic|||||1.31|0.46|0.343
91592267|NCT03962738|183074924|SUPERIORITY||Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.37|2.98|||Regression, Logistic|||||2.98|1.37|<0.001
91592268|NCT03962738|183074924|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.2|||Regression, Logistic|||||3.20|1.42|<0.001
91592269|NCT03962738|183074925|SUPERIORITY||Odds Ratio (OR)|1.19||||0.605|TWO_SIDED|95.0|0.62|2.26|||Regression, Logistic|||||2.26|0.62|0.605
91592270|NCT03962738|183074925|SUPERIORITY||Odds Ratio (OR)|1.8||||0.015|TWO_SIDED|95.0|1.12|2.9|||Regression, Logistic|||||2.90|1.12|0.015
91592271|NCT03962738|183074925|SUPERIORITY||Odds Ratio (OR)|1.23||||0.432|TWO_SIDED|95.0|0.74|2.05|||Regression, Logistic|||||2.05|0.74|0.432
91592272|NCT03962738|183074926|SUPERIORITY||Odds Ratio (OR)|1.77||||0.166|TWO_SIDED|95.0|0.79|3.96|||Regression, Logistic|||||3.96|0.79|0.166
91592273|NCT03962738|183074926|SUPERIORITY||Odds Ratio (OR)|1.34||||0.396|TWO_SIDED|95.0|0.68|2.62|||Regression, Logistic|||||2.62|0.68|0.396
91592274|NCT03962738|183074926|SUPERIORITY||Odds Ratio (OR)|1.58||||0.181|TWO_SIDED|95.0|0.81|3.11|||Regression, Logistic|||||3.11|0.81|0.181
91592275|NCT03962738|183074927|SUPERIORITY||Odds Ratio (OR)|1.44||||0.233|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|||||2.64|0.79|0.233
91592276|NCT03962738|183074927|SUPERIORITY||Odds Ratio (OR)|1.5||||0.092|TWO_SIDED|95.0|0.94|2.41|||Regression, Logistic|||||2.41|0.94|0.092
91592277|NCT03962738|183074927|SUPERIORITY||Odds Ratio (OR)|1.8||||0.017|TWO_SIDED|95.0|1.11|2.92|||Regression, Logistic|||||2.92|1.11|0.017
91592278|NCT03962738|183074928|SUPERIORITY|||||||0.724|||||||ANCOVA|||||||0.724
91592279|NCT03962738|183074928|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.240
91592280|NCT03962738|183074928|SUPERIORITY|||||||0.548|||||||ANCOVA|||||||0.548
91592281|NCT03962738|183074929|SUPERIORITY|||||||0.719|||||||ANCOVA|||||||0.719
91592282|NCT03962738|183074929|SUPERIORITY|||||||0.823|||||||ANCOVA|||||||0.823
91592283|NCT03962738|183074929|SUPERIORITY|||||||0.612|||||||ANCOVA|||||||0.612
91592284|NCT03962738|183074930|SUPERIORITY||Odds Ratio (OR)|1.78||||0.037|TWO_SIDED|95.0|1.04|3.07|||Regression, Logistic|||||3.07|1.04|0.037
91592285|NCT03962738|183074930|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.06|||Regression, Logistic|||||4.06|1.75|<.001
91592286|NCT03962738|183074930|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|2.11|5.06|||Regression, Logistic|||||5.06|2.11|<.001
91592287|NCT03962738|183074931|SUPERIORITY|||||||0.162|||||||ANOVA|||Work Functioning||||0.162
91592288|NCT03962738|183074931|SUPERIORITY|||||||0.356|||||||ANOVA|||Social Functioning||||0.356
91592289|NCT03962738|183074931|SUPERIORITY|||||||0.696|||||||ANOVA|||Energy and Vitality||||0.696
91521498|NCT00313820|182917473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.062||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2 Modelled Results||0.0|-1.0|0.062
91521499|NCT00313820|182917473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.024||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3 Modelled Results||-0.1|-1.1|0.024
91521500|NCT00313820|182917473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.026||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6 Modelled Results||-0.1|-1.1|0.026
91592290|NCT03962738|183074931|SUPERIORITY|||||||0.914|||||||ANOVA|||Feelings and Concerns||||0.914
91592291|NCT03962738|183074931|SUPERIORITY|||||||0.226|||||||ANOVA|||Migraine Symptoms||||0.226
91592292|NCT03962738|183074931|SUPERIORITY|||||||0.31|||||||ANOVA|||Work Functioning||||0.310
91592293|NCT03962738|183074931|SUPERIORITY|||||||0.684|||||||ANOVA|||Social Functioning||||0.684
91782443|NCT02304367|183444377|OTHER|||||||0.093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.093
91782444|NCT02304367|183444377|OTHER|||||||0.89|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.890
91521501|NCT00313820|182917473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.105||95.0|-0.9|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9 Modelled Results||0.1|-0.9|0.105
91521502|NCT00313820|182917473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.592||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12 Modelled Results||0.4|-0.6|0.592
91521503|NCT00313820|182917474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||30% Responders||||0.087
91521504|NCT00313820|182917475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||50% Responders||||0.622
91592294|NCT03962738|183074931|SUPERIORITY|||||||0.864|||||||ANOVA|||Energy and Vitality||||0.864
91592295|NCT03962738|183074931|SUPERIORITY|||||||0.412|||||||ANOVA|||Feelings and Concerns||||0.412
91592296|NCT03962738|183074931|SUPERIORITY|||||||0.025|||||||ANOVA|||Migraine Symptoms||||0.025
91592297|NCT03962738|183074931|SUPERIORITY|||||||0.619|||||||ANOVA|||Work Functioning||||0.619
91592298|NCT03962738|183074931|SUPERIORITY|||||||0.824|||||||ANOVA|||Social Functioning||||0.824
91592299|NCT03962738|183074931|SUPERIORITY|||||||0.476|||||||ANOVA|||Energy and Vitality||||0.476
91592300|NCT03962738|183074931|SUPERIORITY|||||||0.352|||||||ANOVA|||Feelings and Concerns||||0.352
91592301|NCT03962738|183074931|SUPERIORITY|||||||0.044|||||||ANOVA|||Migraine Symptoms||||0.044
91592302|NCT02170779|183074932|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
91592303|NCT02170779|183074933|SUPERIORITY_OR_OTHER|||||||0.738|||||||Wilcoxon (Mann-Whitney)|||||||0.738
91592304|NCT02170779|183074934|SUPERIORITY_OR_OTHER|||||||0.8434|||||||Wilcoxon (Mann-Whitney)|||||||0.8434
91592305|NCT02170779|183074935|SUPERIORITY_OR_OTHER|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||||||0.638
91592306|NCT02170779|183074936|SUPERIORITY_OR_OTHER|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
91592307|NCT02170779|183074937|SUPERIORITY_OR_OTHER|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||This analysis refers to the physical component of the MSIS-29||||0.144
91592308|NCT02170779|183074937|SUPERIORITY_OR_OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||This refers to the psychological analysis for the MSIS-29.||||0.953
91592309|NCT02170779|183074938|SUPERIORITY_OR_OTHER|||||||0.915|||||||Wilcoxon (Mann-Whitney)|||||||0.915
91592310|NCT02170779|183074939|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
91592311|NCT02170779|183074940|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91592312|NCT02367066|183074941|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.02||0.02|TWO_SIDED|80.0|0.9|0.98||1-sided|Mixed Models Analysis|||||0.98|0.90|0.02
91592313|NCT02367066|183074942|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.03||0.06|TWO_SIDED|80.0|0.92|0.99||1-sided|Mixed Models Analysis|||||0.99|0.92|0.06
91592314|NCT02367066|183074943|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|80.0|0.96|1.03||1-sided|Mixed Models Analysis|||||1.03|0.96|0.41
91592315|NCT02367066|183074944|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.05||0.06|TWO_SIDED|80.0|0.85|0.99||1-sided|Mixed Models Analysis|||||0.99|0.85|0.06
91592316|NCT02367066|183074945|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.04||0.18|TWO_SIDED|80.0|0.99|1.13||1-sided|Mixed Models Analysis|||||1.13|0.99|0.18
91592317|NCT02367066|183074946|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED|80.0|0.89|0.98||1-sided|Mixed Models Analysis|||||0.98|0.89|0.04
91592318|NCT02367066|183074948|SUPERIORITY_OR_OTHER||Geometric LS MEan Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|80.0|0.91|1.06||1-sided|Mixed Models Analysis|||||1.06|0.91|0.37
91592319|NCT02367066|183074950|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.01||0.06|TWO_SIDED|80.0|1.0|1.04||1-sided|Mixed Models Analysis|||||1.04|1.00|0.06
91592320|NCT02367066|183074951|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.45|TWO_SIDED|90.0|-0.01|0.03||2-sided|Mixed Models Analysis|||||0.03|-0.01|0.45
91613584|NCT01899144|183121466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.21|0.59|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.59|0.21|<0.0001
91782445|NCT02304367|183444377|OTHER|||||||0.059|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.059
91782446|NCT02304367|183444377|SUPERIORITY|||||||0.623||||||Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.|GEE model|||Week 216||||0.623
91782447|NCT02304367|183444377|OTHER|||||||0.411|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.411
91782448|NCT02304367|183444378|OTHER|||||||0.8209|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.8209
91592321|NCT04556136|183074968|NON_INFERIORITY|This non-inferiority study was designed to demonstrate the ability of the phototherapy kiosk to safely administer UVB radiation to participants with varying levels of 25(OH)D and achieve comparable levels of serum 25(OH)D in a similar population of adults randomized to receive RDA of 600 IU vitamin D oral supplementation daily. It is important to evaluate device equivalence to standard of care in the maintenance of sufficient levels of vitamin D in adults 18 - 70 years old.||||||0.01||||||Threshold for significance \<0.05|Wilcoxon (Mann-Whitney)|Effect sizes for significant differences were included as eta squared (ŋ2) values.||The intent-to-treat analysis plan was carried out with all available subject data points. No interim analysis was performed. Exploratory data analyses were conducted on serum vitamin D levels of participants assigned to either the oral supplementation or kiosk group. Analysis was restricted to participants with valid baseline serum vitamin D data and at least one follow-up blood draw. The Shapiro-Wilk test was used to assess the normality of the data distribution.||||0.01
91592322|NCT03492554|183074992|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Specificity = 92% H1: Specificity \> 92 Under the assumption that the true population specificity is 96.5%, 226 subjects who were diagnosed with SR based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject its null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms approximately 300 subjects with no known diagnosis of AF were enrolled.||||<0.0001
91592323|NCT03492554|183074993|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Sensitivity = 90% H1: Sensitivity \> 90% Under the assumption that the true population sensitivity is 95%, 231 subjects who were diagnosed with AF based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject the null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms, a minimum of 260 subjects with a known diagnosis of AF were enrolled.||||<0.0001
91592324|NCT03492554|183074994|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of visual display= 0.8 H1: agreement proportion of visual display\> 0.8 Under the assumption that the true population agreement proportion of visual display was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
91592325|NCT03492554|183074995|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of R wave amplitude = 0.8 H1: agreement proportion of R wave amplitude \> 0.8 Under the assumption that the true population agreement proportion of R wave amplitude was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
91592326|NCT01478360|183074997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.5392|TWO_SIDED|90.0|-0.617|0.285|||Mixed Models Analysis|||||0.285|-0.617|0.5392
91592327|NCT00529451|183075025|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-3.63|-1.25||||||||-1.25|-3.63|
91592328|NCT00529451|183075026|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-0.86|||||TWO_SIDED|95.0|-2.06|0.34||||||||0.34|-2.06|
91592329|NCT00529451|183075027|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-1.48|||||TWO_SIDED|95.0|-2.67|-0.28||||||||-0.28|-2.67|
91592330|NCT01010633|183075039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|5.7|22.9|||Chi-squared|||||22.9|5.7|<0.001
91592331|NCT01010633|183075041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|21.4|40.7|||Chi-squared|||||40.7|21.4|<0.001
91592332|NCT00097773|183075051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.86|TWO_SIDED|95.0|0.54|1.66||There was no significant interaction with ciprofloxacin in this analysis.|Regression, Cox||risk of exacerbation comparing cycled therapy to culture-based therapy|The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.||1.66|0.54|0.86
91592333|NCT00097773|183075051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.2|TWO_SIDED|95.0|0.82|2.54|||Regression, Cox||risk of exacerbation comparing oral cipro to oral placebo|A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||2.54|0.82|0.20
91592334|NCT00097773|183075052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.28||95.0|0.49|1.23|||Regression, Logistic|No interaction with ciprofloxacin usage was observed.|odds of a positive culture comparing cycled therapy to culture-based therapy|Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.||1.23|0.49|0.28
91592335|NCT00097773|183075052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.67|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic||odds of a positive culture comparing the cipro group to the placebo group|Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.||1.71|0.71|0.67
91592336|NCT00097773|183075053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.18|TWO_SIDED|95.0|0.58|1.11|||Regression, Cox|No interaction with ciprofloxacin usage was observed.|Hazard ratio comparing cycled to culture based therapy|The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.||1.11|0.58|0.18
91782449|NCT02304367|183444378|OTHER|||||||0.2851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2851
91782450|NCT02304367|183444378|OTHER|||||||0.6689|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.6689
91782451|NCT02304367|183444378|OTHER|||||||0.1612|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1612
91782452|NCT02304367|183444379|OTHER|||||||0.4093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.4093
91592337|NCT00097773|183075053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.12|TWO_SIDED|95.0|0.94|1.78|||Regression, Cox||Hazard ratio comparing cipro to placebo.|This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||1.78|0.94|0.12
91592338|NCT04305275|183075066|SUPERIORITY||Least Squares (LS) Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.533||0.0491|TWO_SIDED|95.0|-2.14|0.0|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||||0.00|-2.14|0.0491
91592339|NCT04305275|183075067|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.398||0.0468|TWO_SIDED|95.0|-1.6|-0.01|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.01|-1.60|0.0468
91782453|NCT02304367|183444379|OTHER|||||||0.572|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5720
91782454|NCT02304367|183444379|OTHER|||||||0.3501|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.3501
91782455|NCT02304367|183444379|OTHER|||||||0.5172|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.5172
91782456|NCT02304367|183444380|OTHER|||||||0.0046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 24||||0.0046
91782457|NCT02304367|183444380|OTHER|||||||0.0012|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 48||||0.0012
91782458|NCT02304367|183444381|OTHER|||||||0.6475|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.6475
91782459|NCT02304367|183444381|OTHER|||||||0.5319|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5319
91782460|NCT02304367|183444381|OTHER|||||||0.9206|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.9206
91782461|NCT02304367|183444381|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1530
91782462|NCT02304367|183444382|OTHER|||||||0.2125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2125
91782463|NCT02304367|183444382|OTHER|||||||0.1241|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1241
91782464|NCT02304367|183444383|OTHER|||||||0.41|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.410
91782465|NCT02304367|183444383|OTHER|||||||0.21|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.210
91782466|NCT02304367|183444383|OTHER|||||||0.06|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.060
91782467|NCT02304367|183444383|OTHER|||||||0.076|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.076
91782468|NCT02304367|183444383|OTHER|||||||0.171|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.171
91782469|NCT02304367|183444383|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.141
91782470|NCT02304367|183444383|OTHER|||||||0.263|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.263
91782471|NCT02304367|183444383|OTHER|||||||0.32|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.320
91782472|NCT02304367|183444384|OTHER|||||||0.407|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.407
91782473|NCT02304367|183444384|OTHER|||||||0.192|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.192
91782474|NCT02304367|183444384|OTHER|||||||0.106|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.106
91782475|NCT02304367|183444384|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.020
91782476|NCT02304367|183444384|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.002
91782477|NCT02304367|183444384|OTHER|||||||0.22|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.220
91782478|NCT02304367|183444384|OTHER|||||||0.23|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.230
91782479|NCT02304367|183444384|OTHER|||||||0.232|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.232
91782480|NCT02304367|183444385|OTHER|||||||0.082|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.082
91782481|NCT02304367|183444385|OTHER|||||||0.176|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.176
91782482|NCT02304367|183444385|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.047
91782483|NCT02304367|183444385|OTHER|||||||0.017|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.017
91592340|NCT04305275|183075067|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.467||0.3124|TWO_SIDED|95.0|-1.41|0.46|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||0.46|-1.41|0.3124
91592341|NCT04305275|183075067|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.605||0.5148|TWO_SIDED|95.0|-1.61|0.81|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||0.81|-1.61|0.5148
91592342|NCT04305275|183075067|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.59||0.6452|TWO_SIDED|95.0|-1.45|0.91|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||0.91|-1.45|0.6452
91592343|NCT04305275|183075067|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.482||0.1171|TWO_SIDED|95.0|-1.73|0.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||0.20|-1.73|0.1171
91592344|NCT04305275|183075067|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.557||0.2724|TWO_SIDED|95.0|-0.5|1.73|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||1.73|-0.50|0.2724
91592345|NCT04305275|183075068|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.658||0.8784|TWO_SIDED|95.0|-1.42|1.21|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||1.21|-1.42|0.8784
91592346|NCT04305275|183075068|SUPERIORITY||LS mean difference|0.93|STANDARD_ERROR_OF_MEAN|0.687||0.1795|TWO_SIDED|95.0|-0.44|2.3|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||2.30|-0.44|0.1795
91592347|NCT04305275|183075068|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.829||0.5588|TWO_SIDED|95.0|-2.15|1.17|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.17|-2.15|0.5588
91592348|NCT04305275|183075068|SUPERIORITY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.796||0.5036|TWO_SIDED|95.0|-1.06|2.13|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.13|-1.06|0.5036
91592349|NCT04305275|183075068|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.736||0.6636|TWO_SIDED|95.0|-1.15|1.79|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||1.79|-1.15|0.6636
91592350|NCT04305275|183075068|SUPERIORITY||LS mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.756||0.3999|TWO_SIDED|95.0|-0.87|2.15|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.15|-0.87|0.3999
91782484|NCT02304367|183444385|OTHER|||||||0|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.000
91592351|NCT04305275|183075068|SUPERIORITY||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.776||0.3933|TWO_SIDED|95.0|-0.88|2.22|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||2.22|-0.88|0.3933
91592352|NCT04305275|183075069|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.167||0.0193|TWO_SIDED|95.0|-5.14|-0.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.47|-5.14|0.0193
91592353|NCT04305275|183075069|SUPERIORITY||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.277||0.0243|TWO_SIDED|95.0|-5.51|-0.4|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15||-0.40|-5.51|0.0243
91592354|NCT04305275|183075069|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.209||0.0385|TWO_SIDED|95.0|-4.98|-0.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||-0.14|-4.98|0.0385
91592355|NCT04305275|183075069|SUPERIORITY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|1.221||0.2682|TWO_SIDED|95.0|-3.81|1.08|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||1.08|-3.81|0.2682
91592356|NCT04305275|183075069|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|1.233||0.3649|TWO_SIDED|95.0|-1.34|3.59|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||3.59|-1.34|0.3649
91782485|NCT02304367|183444385|OTHER|||||||0.057|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.057
91782486|NCT02304367|183444385|OTHER|||||||0.071|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.071
91782487|NCT02304367|183444385|OTHER|||||||0.07|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.070
91782488|NCT02304367|183444386|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.014
91592357|NCT04305275|183075070|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.078||0.2478|TWO_SIDED|95.0|-3.41|0.9|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||0.90|-3.41|0.2478
91592358|NCT04305275|183075070|SUPERIORITY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.192||0.4486|TWO_SIDED|95.0|-3.29|1.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||1.47|-3.29|0.4486
91592359|NCT04305275|183075070|SUPERIORITY||LS mean difference|-1.52|STANDARD_ERROR_OF_MEAN|1.352||0.2662|TWO_SIDED|95.0|-4.22|1.19|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.19|-4.22|0.2662
91592360|NCT04305275|183075070|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.282||0.9965|TWO_SIDED|95.0|-2.56|2.57|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.57|-2.56|0.9965
91592361|NCT04305275|183075070|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|1.222||0.8437|TWO_SIDED|95.0|-2.68|2.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||2.20|-2.68|0.8437
91592362|NCT04305275|183075070|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.232||0.796|TWO_SIDED|95.0|-2.78|2.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.14|-2.78|0.7960
91592363|NCT04305275|183075070|SUPERIORITY||LS mean difference|2.28|STANDARD_ERROR_OF_MEAN|1.119||0.0456|TWO_SIDED|95.0|0.05|4.52|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||4.52|0.05|0.0456
91592364|NCT02456662|183075113|SUPERIORITY|Based on previous work as well as anecdotal data from our clinic population, we expect vomiting to occur in approximately 30% of our patients who take their doxycycline the night before their procedure. To have 80% power to detect a 50% decrease in nausea and vomiting, we will need 122 patients in each arm of the study.||||||0|||||||Chi-squared|||||||0.00
91592365|NCT02303704|183075120|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||P-value less than 0.05 was considered significant|t-test, 2 sided|two compare two independent quantitative groups||Null hypothesis was there is no significant difference between the means of two groups||||<0.05
91592366|NCT02303704|183075121|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91592367|NCT02303704|183075122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||p-value \<0.05 was considered significant.|t-test, 2 sided|To compare the means between the two groups, to find out the significant difference between Group I and II.||Null Hypothesis: The dose of nor-adrenaline on weaning from CPB is same for Group I and II.||||<0.05
91782489|NCT02304367|183444386|OTHER|||||||0.309|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.309
91592368|NCT02303704|183075123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to chek the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91592369|NCT02303704|183075124|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||p- value less than 0.05 was considered as significant difference in proportion between the two groups|Chi-squared|two compare the qualitative data between two groups||Null Hypothesis:The proportion of IABP use is same between the two groups||||<0.05
91782490|NCT02304367|183444386|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.036
91782491|NCT02304367|183444386|OTHER|||||||0.096|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.096
91782492|NCT02304367|183444386|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.005
91782493|NCT02304367|183444386|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.022
91782494|NCT02304367|183444386|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.022
91592370|NCT02303704|183075125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||P-value \<0.05 was considered to be significant i.e. operative mortality is not same between the two groups|Fisher Exact|Fisher exact test was used because 1 cell (25%) have expected count less than 5.||Null Hypothesis: Operative mortality ratio is same in both groups||||<0.05
91613931|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.403||||0.0267|TWO_SIDED|95.0|1.04|1.892|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.892|1.040|0.0267
91782495|NCT02304367|183444386|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.004
91782496|NCT02304367|183444387|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
91782497|NCT02304367|183444387|OTHER|||||||0.019|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.019
91592371|NCT01034540|183075126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.959||||||Values were not normally distributed, thus analyses were performed on ranked values and medians (IQL) are presented.|ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||An evaluable sample of 19 subjects provided 80% power (5% alpha-level, 2-tailed) to detect a 2.1 unit difference between control and active in MISI, assuming a 3.0 unit standard deviation (SD). Repeated measures ANOVA was used to assess responses to treatment. Initial repeated measures models contained terms of treatment period, and sequence as fixed effects, with subject modeled as random effect; models were reduced until only significant terms or treatment remained.||||0.959
91592372|NCT01034540|183075127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||||||0.037
91592373|NCT01034540|183075127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||||||All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).|ANOVA|||||||0.073
91592374|NCT01353079|183075133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.834|||<|0.05|TWO_SIDED|95.0|-1.298|-0.369|||ANCOVA|||||-0.369|-1.298|<0.05
91592375|NCT01353079|183075134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.857|||<|0.05|TWO_SIDED|95.0|-1.388|-0.326|||ANCOVA|||||-0.326|-1.388|<0.05
91592376|NCT01353079|183075135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.771|||<|0.05|TWO_SIDED|95.0|-1.213|-0.329|||ANCOVA|||||-0.329|-1.213|<0.05
91592377|NCT01353079|183075136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.788|||<|0.05|TWO_SIDED|95.0|-1.291|-0.284|||ANCOVA|||||-0.284|-1.291|<0.05
91592378|NCT01721876|183075143|SUPERIORITY|The 2-sided test of the hypothesis was performed at a 0.05 level of significance. An odds ratio (OR) = 1 would indicate that the odds of achieving CR+CRi with Volasertib + Low-dose Cytarabine is equal to the odds of achieving CR+CRi with Placebo + Low-dose Cytarabine , whereas an OR ≠ 1 would indicate the opposite. H0, CR+CRi: OR = 1 vs. Ha, CR+CRi: OR ≠ 1.|Odds Ratio (OR)|1.8751||||0.0024|TWO_SIDED|95.0|1.2432|2.8281|||Cochran-Mantel-Haenszel||Common odds ratio is calculated by Mantel-Haenszel estimate adjusting for the two stratification factors (baseline Eastern Cooperative Oncology Group (ECOG) and type of AML). If odds ratio is above 1 then it favours Volasertib+Low-dose Cytarabine.|This analysis was exploratory and descriptive.||2.8281|1.2432|0.0024
91592379|NCT01721876|183075144|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.97||||0.7571|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.7571
91592380|NCT01721876|183075145|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.96||||0.6718|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.6718
91592381|NCT01721876|183075146|OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.7|2.7|||Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|||2.7|0.7|
91592382|NCT03805750|183075152|OTHER|||||||0.52|||||||Regression, Logistic|||||||0.52
91592383|NCT05293743|183075167|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.67||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.82.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by parent-reported brace logs.||||0.67
91592384|NCT05293743|183075167|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.23||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.70.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by iButton temperature sensors.||||0.23
91782498|NCT02304367|183444387|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
91782499|NCT02304367|183444387|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.006
91782500|NCT02304367|183444387|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
91782501|NCT02304367|183444387|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||< 0.001
91782502|NCT02304367|183444387|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.002
91782503|NCT02304367|183444387|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.002
91782504|NCT02304367|183444388|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.016
91782505|NCT02304367|183444388|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.004
91592385|NCT05293743|183075168|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.86||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.68.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by parent-reported brace logs.||||0.86
91592386|NCT05293743|183075168|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.21||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.94.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by iButton temperature sensors.||||0.21
91592387|NCT00493220|183075173|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|111.79|||||TWO_SIDED|90.0|108.57|115.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||115.12|108.57|
91592388|NCT00493220|183075173|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|60.81|||||TWO_SIDED|90.0|59.06|62.62|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||62.62|59.06|
91592389|NCT00493220|183075173|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|54.4|||||TWO_SIDED|90.0|52.82|56.01|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||56.01|52.82|
91592390|NCT00493220|183075174|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0|||<|0.01|TWO_SIDED|90.0|-1.25|-0.75|||Wilcoxon signed-rank test||HYLENEX SC minus Placebo SC|||-0.75|-1.25|<0.01
91592391|NCT00493220|183075174|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.52|||<|0.01|TWO_SIDED|90.0|1.27|1.71|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||1.71|1.27|<0.01
91592392|NCT00493220|183075174|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.52|||<|0.01|TWO_SIDED|90.0|2.26|2.76|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||2.76|2.26|<0.01
91592393|NCT00493220|183075175|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.99|||||TWO_SIDED|90.0|98.95|105.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||105.12|98.95|
91592394|NCT00493220|183075175|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.79|||||TWO_SIDED|90.0|103.61|110.07|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.07|103.61|
91592395|NCT00493220|183075175|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|104.71|||||TWO_SIDED|90.0|101.59|107.92|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||107.92|101.59|
91782506|NCT02304367|183444388|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
91592396|NCT00493220|183075176|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.76|||||TWO_SIDED|90.0|98.64|104.98|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||104.98|98.64|
91592397|NCT00493220|183075176|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.95|||||TWO_SIDED|90.0|103.67|110.33|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.33|103.67|
91592398|NCT00493220|183075176|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|105.1|||||TWO_SIDED|90.0|101.87|108.42|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||108.42|101.87|
91592399|NCT04360551|183075208|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
91782507|NCT02304367|183444388|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
91592400|NCT04360551|183075209|SUPERIORITY||||||>|0.5|||||||Kruskal-Wallis|||||||>0.5
91592401|NCT03496012|183075210|SUPERIORITY||Difference in Proportions|2.9|||=|0.354|TWO_SIDED|95.0|-3.1|15.0|||Fisher's Exact|||||15|-3.1|=0.354
91592402|NCT03496012|183075210|SUPERIORITY||Difference in proportions|4.6|||=|0.245|TWO_SIDED|95.0|-1.4|12.8|||Fisher's Exact|||||12.8|-1.4|=0.245
91592403|NCT03496012|183075212|SUPERIORITY||Difference in proportions|16.0|||||TWO_SIDED|95.0|5.3|32.2||||||||32.2|5.3|
91592404|NCT03496012|183075212|SUPERIORITY||Difference in proportions|12.2|||||TWO_SIDED|95.0|3.5|23.0||||||||23|3.5|
91592405|NCT03496012|183075213|SUPERIORITY||Difference in proportions|2.8|||||TWO_SIDED|95.0|-17.2|21.0||||||||21|-17.2|
91592406|NCT03496012|183075213|SUPERIORITY||Difference in proportions|15.3|||||TWO_SIDED|95.0|0.3|30.1||||||||30.1|0.3|
91592407|NCT02232802|183075256|EQUIVALENCE|Following logarithmic transformation, Cmax values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|99.42|||||TWO_SIDED|95.0|96.28|102.65|||||Geometric least square means are being compared.|Statistical comparison for Anti-FXa||102.65|96.28|
91592408|NCT02232802|183075256|EQUIVALENCE|Following logarithmic transformation, Cmax was subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|91.55|||||TWO_SIDED|95.0|86.65|96.73|||||Geometric least square means are being compared.|Statistical comparison on Anti-FIIa||96.73|86.65|
91782508|NCT02304367|183444388|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
91782509|NCT02304367|183444388|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.036
91592409|NCT02232802|183075257|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|102.89|||||TWO_SIDED|95.0|100.67|105.15|||||Geometric least square means are being compared.|Anti-FXa statistical comparison||105.15|100.67|
91592410|NCT02232802|183075257|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|92.37|||||TWO_SIDED|95.0|87.72|97.25|||||Geometric least square means are being compared.|Anti-FIIa comparison||97.25|87.72|
91592411|NCT02232802|183075258|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|104.26|||||TWO_SIDED|95.0|101.68|106.9|||||Geometric least square means are being compared.|Anti-FXA comparison||106.9|101.68|
91592412|NCT02232802|183075258|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|90.44|||||TWO_SIDED|95.0|85.38|95.8|||||Geometric least square means are being compared.|Anti-FIIa comparison||95.8|85.38|
91592413|NCT02232802|183075259|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.7642|TWO_SIDED|95.0|-0.5|0.5||An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FXa comparison||0.5|-0.5|0.7642
91592414|NCT02232802|183075259|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.9464|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FIIa comparison||0.5|-0.5|0.9464
91592415|NCT02232802|183075265|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|103.94|||||TWO_SIDED|95.0|101.22|106.73||||||||106.73|101.22|
91592416|NCT02232802|183075266|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|108.59|||||TWO_SIDED|95.0|103.93|113.46||||||||113.46|103.93|
91592417|NCT02232802|183075267|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|102.76|||||TWO_SIDED|95.0|97.51|108.28||||||||108.28|97.51|
91592418|NCT02232802|183075268|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|114.91|||||TWO_SIDED|95.0|102.29|129.08||||||||129.08|102.29|
91592419|NCT02232802|183075269|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Median Difference (Final Values)|0.0|||=|0.8554|TWO_SIDED|95.0|-0.5|0.5|||ANOVA|||||0.5|-0.5|= 0.8554
91592420|NCT02232802|183075270|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|geometric least square mean ratio|100.86|||||TWO_SIDED|95.0|99.27|102.47||||||||102.47|99.27|
91782510|NCT02304367|183444388|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.008
91592421|NCT02232802|183075271|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|geometric least square mean ratio|95.13|||||TWO_SIDED|95.0|85.7|105.6||||||||105.6|85.7|
91592422|NCT02232802|183075272|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.6857|TWO_SIDED|95.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.5|-0.25|= 0.6857
91592423|NCT02232802|183075278|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|111.39|||||TWO_SIDED|95.0|105.89|117.17||||||||117.17|105.89|
91592424|NCT02232802|183075279|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|113.82|||||TWO_SIDED|95.0|107.47|120.53||||||||120.53|107.47|
91782511|NCT02304367|183444388|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.008
91782512|NCT02304367|183444389|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.006
91782513|NCT02304367|183444389|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.003
91782514|NCT02304367|183444389|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||<0.001
91782515|NCT02304367|183444389|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
91782516|NCT02304367|183444389|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
91782517|NCT02304367|183444389|SUPERIORITY|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.007
91782518|NCT02304367|183444389|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.005
91592425|NCT02232802|183075284|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.9217|TWO_SIDED|95.0|-0.13|0.13|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.13|-0.13|= 0.9217
91592426|NCT00885703|183075290|SUPERIORITY|||||||0.0012||||||Analysis did not adjust for multiple comparisons.|Chi-squared|||Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.||||0.0012
91592427|NCT00885703|183075291|SUPERIORITY|||||||0.012|||||||Fisher Exact|||Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.||||0.012
91592428|NCT00885703|183075292|SUPERIORITY|||||||0.019|||||||Kruskal-Wallis|||Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.||||0.019
91592429|NCT00885703|183075293|SUPERIORITY|||||||0.0894||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.0894
91592430|NCT00885703|183075293|SUPERIORITY|||||||0.4828||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.4828
91592431|NCT00885703|183075293|SUPERIORITY|||||||0.1766||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.1766
91592432|NCT00346073|183075301|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.43|||||TWO_SIDED|95.0|-1.47|0.84||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-diphtheria (anti-D) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.84|-1.47|
91592433|NCT00346073|183075301|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.42|||||TWO_SIDED|95.0|-0.9|0.11||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.11|-0.9|
91592434|NCT00346073|183075302|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-1.04|||||TWO_SIDED|95.0|-1.97|0.0||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 1.0 IU/mL, one month after vaccination.||0|-1.97|
91592435|NCT00346073|183075304|SUPERIORITY||Booster response|77.2|||||TWO_SIDED|95.0|74.9|79.3||||||"Demonstration that anti-PT booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||79.3|74.9|
91592436|NCT00346073|183075304|SUPERIORITY||Booster response|96.9|||||TWO_SIDED|95.0|95.8|97.7||||||"Demonstration that anti-FHA booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||97.7|95.8|
91592437|NCT00346073|183075304|SUPERIORITY||Booster response|93.2|||||TWO_SIDED|95.0|91.8|94.4||||||"Demonstration that anti-PRN booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||94.4|91.8|
91592438|NCT03600142|183075334|NON_INFERIORITY|For WLHIV (n=55), chi-square tests were used to assess differences between conditions in the proportion of participants who were retained in HIV care at 3 months post enrollment.||||||0.963|||||||Chi-squared|||We were aware that our resources of time and funding would not be sufficient to detect a significant difference in the HIV care outcome, and that we would only be able to detect observational signals of impact. We aimed for a minimum of 50 WLHIV, which is considered an adequate sample to assess feasibility and acceptability in a pilot intervention study. Given an estimated 5% HIV prevalence among women presenting for ANC, this required us to enroll 1000 female participants.||||0.963
91592439|NCT02687542|183075370|OTHER|Bayesian Dose Response Analysis|Bayesian Dose Reponse Estimate|-0.693|STANDARD_ERROR_OF_MEAN|0.6162||0.5776|TWO_SIDED|90.0|-1.713|0.304||Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity|Bayesian Dose Response Analysis|Estimate and 90% credible interval of Bayesian dose response difference from placebo||||0.304|-1.713|0.5776
91592440|NCT00857532|183075384|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||Spearman's Rank Order Correlation|||"P-value for Attention correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score."||||0.021
91592441|NCT00857532|183075384|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Spearman's Rank Order Correlation|||"P-value for Initiation/Perseveration correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score."||||0.077
91592442|NCT00857532|183075384|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Spearman's Rank Order Correlation|||"P-value for Construction correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score."||||0.364
91592443|NCT00857532|183075384|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Spearman's Rank Order Correlation|||"P-value for Conceptualization correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score."||||0.266
91592444|NCT00857532|183075384|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Spearman's Rank Order Correlation|||"P-value for Memory correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score."||||0.152
91592445|NCT00857532|183075384|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Spearman's Rank Order Correlation|||"P-value for DRS-2 Total correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score."||||0.041
91592446|NCT00857532|183075385|SUPERIORITY_OR_OTHER|||||||0.0411||95.0|||||Spearman's Rank Order Correlation|||"P-value for Amyloid beta correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta."||||0.0411
91592447|NCT00857532|183075385|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Spearman's Rank Order Correlation|||"P-value for Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau."||||0.5800
91782519|NCT02304367|183444389|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
91592448|NCT00857532|183075385|SUPERIORITY_OR_OTHER|||||||0.8164||95.0|||||Spearman's Rank Order Correlation|||"P-value for Phospho-Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau."||||0.8164
91592449|NCT02187471|183075436|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.4601|TWO_SIDED|95.0|-0.52|0.23|||Difference of means|||||0.23|-0.52|0.4601
91592450|NCT02187471|183075436|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.77|-0.03|||Difference of means|||||-0.03|-0.77|0.0350
91592451|NCT02187471|183075436|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.191||0.0001|TWO_SIDED|95.0|-1.12|-0.37|||Difference of means|||||-0.37|-1.12|0.0001
91592452|NCT02187471|183075436|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.193||0.0019|TWO_SIDED|95.0|0.22|0.98|||Difference of means|||||0.98|0.22|0.0019
91782520|NCT02304367|183444390|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.009
91782521|NCT02304367|183444390|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.020
91592453|NCT02187471|183075436|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.192||0.0761|TWO_SIDED|95.0|-0.04|0.72|||Difference of means|||||0.72|-0.04|0.0761
91782522|NCT02304367|183444390|OTHER|||||||0.044|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.044
91782523|NCT02304367|183444390|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
91782524|NCT02304367|183444390|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.015
91782525|NCT02304367|183444390|OTHER|||||||0.125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.125
91782526|NCT02304367|183444390|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.004
91782527|NCT02304367|183444390|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.018
91782528|NCT02304367|183444391|OTHER|||||||0.148|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.148
91782529|NCT02304367|183444391|OTHER|||||||0.295|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.295
91782530|NCT02304367|183444391|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.005
91782531|NCT02304367|183444391|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
91782532|NCT02304367|183444391|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.014
91782533|NCT02304367|183444391|OTHER|||||||0.14|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.140
91782534|NCT02304367|183444391|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
91782535|NCT02304367|183444391|OTHER|||||||0.142|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.142
91782536|NCT02304367|183444392|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
91782537|NCT02304367|183444392|OTHER|||||||0.077|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.077
91782538|NCT02304367|183444392|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.046
91782539|NCT02304367|183444392|OTHER|||||||0.049|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.049
91782540|NCT02304367|183444392|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.003
91782541|NCT02304367|183444392|OTHER|||||||0.073|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.073
91592454|NCT02187471|183075438|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|1.67||0.3407|TWO_SIDED|95.0|-4.86|1.68|||Difference of means|||||1.68|-4.86|0.3407
91592455|NCT02187471|183075438|SUPERIORITY||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.669||0.0012|TWO_SIDED|95.0|-8.69|-2.15|||Difference of means|||||-2.15|-8.69|0.0012
91592456|NCT02187471|183075438|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|1.665||0.0083|TWO_SIDED|95.0|-7.66|-1.13|||Difference of means|||||-1.13|-7.66|0.0083
91592457|NCT02187471|183075438|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.677||0.0946|TWO_SIDED|95.0|-0.48|6.09|||Difference of means|||||6.09|-0.48|0.0946
91782542|NCT02304367|183444392|OTHER|||||||0.109|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.109
91782543|NCT02304367|183444392|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
91782544|NCT02304367|183444393|OTHER|||||||0.328|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.328
91782545|NCT02304367|183444393|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.015
91782546|NCT02304367|183444393|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.020
91782547|NCT02304367|183444393|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.004
91782548|NCT02304367|183444393|OTHER|||||||0.021|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.021
91782549|NCT02304367|183444393|OTHER|||||||0.08|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.080
91782550|NCT02304367|183444393|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
91592458|NCT02187471|183075438|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|1.669||0.5384|TWO_SIDED|95.0|-4.3|2.24|||Difference of means|||||2.24|-4.30|0.5384
91592459|NCT02187471|183075440|SUPERIORITY||Difference in least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.003|TWO_SIDED|95.0|-1.5|-0.3|||ANCOVA|||||-0.3|-1.5|0.0030
91592460|NCT02187471|183075440|SUPERIORITY||Difference in least squares means|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||ANCOVA|||||-1.1|-2.3|<0.0001
91592461|NCT02187471|183075440|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.7|-0.6|||ANCOVA|||||-0.6|-1.7|0.0001
91592462|NCT02187471|183075440|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3562|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3562
91592463|NCT02187471|183075440|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0862|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|||||0.1|-1.1|0.0862
91592464|NCT02187471|183075441|SUPERIORITY||Difference in least square means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5183|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.5183
91782551|NCT02304367|183444393|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.003
91782552|NCT02304367|183444394|OTHER|||||||0.207|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.207
91782553|NCT02304367|183444394|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.008
91782554|NCT02304367|183444394|OTHER|||||||0.598|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.598
91782555|NCT02304367|183444394|OTHER|||||||0.237|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.237
91592465|NCT02187471|183075441|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2669|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.2|-0.9|0.2669
91592466|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.463|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.4630
91592467|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.928|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.5|0.9280
91592468|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7089|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.7|0.7089
91592469|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0669|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0|-1.1|0.0669
91521505|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|-1.0|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1; Modelled Results||-0.1|-1.0|0.027
91592470|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0081|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||-0.2|-1.3|0.0081
91592471|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0867|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.1|-1.0|0.0867
91592472|NCT02187471|183075441|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.9066|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.6|0.9066
91592473|NCT02187471|183075441|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3509|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.3|-0.8|0.3509
91592474|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|2.187|STANDARD_ERROR_OF_MEAN|0.6203||0.0004|TWO_SIDED|95.0|0.97|3.404|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.404|0.970|0.0004
91592475|NCT02187471|183075442|SUPERIORITY||Difference of least squares means|2.483|STANDARD_ERROR_OF_MEAN|0.6209|<|0.0001|TWO_SIDED|95.0|1.265|3.701|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||3.701|1.265|<0.0001
91592476|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|2.621|STANDARD_ERROR_OF_MEAN|0.6215|<|0.0001|TWO_SIDED|95.0|1.401|3.84|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||3.840|1.401|<0.0001
91592477|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|-0.434|STANDARD_ERROR_OF_MEAN|0.6245||0.4877|TWO_SIDED|95.0|-1.659|0.792|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.792|-1.659|0.4877
91592478|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|-0.137|STANDARD_ERROR_OF_MEAN|0.6252||0.8263|TWO_SIDED|95.0|-1.364|1.089|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.089|-1.364|0.8263
91592479|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|0.228|STANDARD_ERROR_OF_MEAN|0.7345||0.7567|TWO_SIDED|95.0|-1.213|1.669|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.669|-1.213|0.7567
91592480|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|0.7349|STANDARD_ERROR_OF_MEAN|0.7349||0.0787|TWO_SIDED|95.0|-0.149|2.735|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||2.735|-0.149|0.0787
91592481|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|0.7358|STANDARD_ERROR_OF_MEAN|0.7358||0.3516|TWO_SIDED|95.0|-0.758|2.129|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.129|-0.758|0.3516
91592482|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|-0.458|STANDARD_ERROR_OF_MEAN|0.7372||0.5344|TWO_SIDED|95.0|-1.905|0.988|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.988|-1.905|0.5344
91592483|NCT02187471|183075442|SUPERIORITY||Difference in least squares means|0.607|STANDARD_ERROR_OF_MEAN|0.7379||0.4107|TWO_SIDED|95.0|-0.84|2.055|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||2.055|-0.840|0.4107
91592484|NCT02187471|183075443|SUPERIORITY||Difference in least squares means|0.0203|STANDARD_ERROR_OF_MEAN|0.01369||0.1394|TWO_SIDED|95.0|-0.0066|0.0471|||ANCOVA|||||0.0471|-0.0066|0.1394
91592485|NCT02187471|183075443|SUPERIORITY||Difference in least squares means|0.0211|STANDARD_ERROR_OF_MEAN|0.01369||0.1237|TWO_SIDED|95.0|-0.0058|0.048|||ANCOVA|||||0.0480|-0.0058|0.1237
91592486|NCT02187471|183075443|SUPERIORITY||Difference in least squares means|0.0386|STANDARD_ERROR_OF_MEAN|0.01371||0.0049|TWO_SIDED|95.0|0.0117|0.0655|||ANCOVA|||||0.0655|0.0117|0.0049
91592487|NCT02187471|183075443|SUPERIORITY||Difference in least squares means|-0.0184|STANDARD_ERROR_OF_MEAN|0.01378||0.1824|TWO_SIDED|95.0|-0.0454|0.0086|||ANCOVA|||||0.0086|-0.0454|0.1824
91592488|NCT02187471|183075443|SUPERIORITY||Difference in least squares means|-0.0175|STANDARD_ERROR_OF_MEAN|0.01378||0.2036|TWO_SIDED|95.0|-0.0446|0.0095|||ANCOVA|||||0.0095|-0.0446|0.2036
91592489|NCT02187471|183075444|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.162||0.0006|TWO_SIDED|95.0|-0.87|-0.24|||Mixed Models Analysis|||||-0.24|-0.87|0.0006
91592490|NCT02187471|183075444|SUPERIORITY||Difference in least squares means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.57|||Mixed Models Analysis|||||-0.57|-1.20|<0.0001
91592491|NCT02187471|183075444|SUPERIORITY||Difference in least squares means|-0.95|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|-1.27|-0.63|||Mixed Models Analysis|||||-0.63|-1.27|<0.0001
91592492|NCT02187471|183075444|SUPERIORITY||Difference in least squares means|0.39|STANDARD_ERROR_OF_MEAN|0.162||0.0158|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.0158
91592493|NCT02187471|183075444|SUPERIORITY||Difference in least squares means|0.07|STANDARD_ERROR_OF_MEAN|0.161||0.6819|TWO_SIDED|95.0|-0.25|0.38|||Mixed Models Analysis|||||0.38|-0.25|0.6819
91592494|NCT02187471|183075446|SUPERIORITY||Difference of least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
91592495|NCT02187471|183075446|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2005|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.2005
91592496|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||-0.3|-1.0|0.0010
91592497|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.0|0.2|0.0030
91592498|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3351|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3351
91592499|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
91592500|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0782|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0782
91592501|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0068|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||-0.1|-0.9|0.0068
91592502|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0169|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0169
91592503|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1481|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1481
91592504|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
91592505|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0088|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||-0.1|-0.8|0.0088
91592506|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||-0.3|-0.9|0.0005
91592507|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.0|0.0627
91592508|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3064|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3064
91592509|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
91592510|NCT02187471|183075446|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0868|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0868
91592511|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||-0.3|-1.1|0.0004
91592512|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0271|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0271
91592513|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6838|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.3|0.6838
91592514|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.791|STANDARD_ERROR_OF_MEAN|0.172|<|0.0001|TWO_SIDED|95.0|-1.129|-0.454|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.454|-1.129|<0.0001
91592515|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.33|STANDARD_ERROR_OF_MEAN|0.1718||0.0552|TWO_SIDED|95.0|-0.667|0.007|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.007|-0.667|0.0552
91592516|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-0.612|STANDARD_ERROR_OF_MEAN|0.1718||0.0004|TWO_SIDED|95.0|-0.95|-0.275|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||-0.275|-0.950|0.0004
91592517|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.462|STANDARD_ERROR_OF_MEAN|0.1729||0.0077|TWO_SIDED|95.0|0.122|0.801|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.801|0.122|0.0077
91782556|NCT02304367|183444394|OTHER|||||||0.899|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.899
91521506|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.038||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2; Modelled Results||-0.0|-1.0|0.038
91521507|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004||95.0|-1.2|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3; Modelled Results||-0.2|-1.2|0.004
91521508|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.005||95.0|-1.1|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6; Modelled Results||-0.2|-1.1|0.005
91521509|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.078||95.0|-0.9|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9; Modelled Results||0.0|-0.9|0.078
91521510|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.663||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12; Modelled Results||0.4|-0.6|0.663
91521511|NCT00313820|182917476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.627||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Endpoint \[Week 12 or ET\]; Modelled Results||0.4|-0.6|0.627
91521512|NCT00313820|182917477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.05||0.741||95.0|-7.0|5.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate|ANCOVA|||Modelled Results||5.0|-7.0|0.741
91521513|NCT00313820|182917478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.216||95.0|-1.0|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Burning Pain Week 12 \[LOCF\]; Modelled Results||0.2|-1.0|0.216
91592518|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|0.179|STANDARD_ERROR_OF_MEAN|0.173||0.3014|TWO_SIDED|95.0|-0.161|0.518|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.518|-0.161|0.3014
91592519|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|9.6|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|4.9|14.3|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||14.3|4.9|<0.0001
91782557|NCT02304367|183444394|OTHER|||||||0.585|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.585
91782558|NCT02304367|183444394|OTHER|||||||0.461|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.461
91592520|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|8.5|STANDARD_ERROR_OF_MEAN|2.39||0.0004|TWO_SIDED|95.0|3.8|13.2|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||13.2|3.8|0.0004
91592521|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|10.4|STANDARD_ERROR_OF_MEAN|2.39|<|0.0001|TWO_SIDED|95.0|5.7|15.1|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg BID||15.1|5.7|<0.0001
91592522|NCT02187471|183075446|SUPERIORITY||Difference in least squares means|-1.1|STANDARD_ERROR_OF_MEAN|2.41||0.6449|TWO_SIDED|95.0|-5.8|3.6|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.6|-5.8|0.6449
91592523|NCT02187471|183075446|SUPERIORITY||Difference in least square means|0.8|STANDARD_ERROR_OF_MEAN|2.41||0.734|TWO_SIDED|95.0|-3.9|5.5|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.5|-3.9|0.7340
91592524|NCT02187471|183075447|SUPERIORITY||Difference in least squares means|-0.016|STANDARD_ERROR_OF_MEAN|0.0225||0.4816|TWO_SIDED|95.0|-0.06|0.028|||ANCOVA|||||0.028|-0.060|0.4816
91592525|NCT02187471|183075447|SUPERIORITY||Difference in least square means|-0.064|STANDARD_ERROR_OF_MEAN|0.0225||0.0044|TWO_SIDED|95.0|-0.109|-0.02|||ANCOVA|||||-0.020|-.109|0.0044
91592526|NCT02187471|183075447|SUPERIORITY||Difference in least squares means|-0.074|STANDARD_ERROR_OF_MEAN|0.0226||0.001|TWO_SIDED|95.0|-0.119|-0.03|||ANCOVA|||||-0.030|-0.119|0.0010
91782559|NCT02304367|183444394|OTHER|||||||0.583|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.583
91592527|NCT02187471|183075447|SUPERIORITY||Difference in least squares means|0.059|STANDARD_ERROR_OF_MEAN|0.0226||0.0094|TWO_SIDED|95.0|0.014|0.103|||ANCOVA|||||0.103|0.014|0.0094
91521514|NCT00313820|182917478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.76||95.0|-0.4|0.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Pressing Pain Week 12 \[LOCF\]; Modelled Results||0.6|-0.4|0.760
91648424|NCT03053622|183189482|OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.25|23.97|||||"In this outcome, the median difference is not calculated by subtracting two observations, it is derived by Hodges-Lehmann approach to estimating location shift. This method will give the value of 0.25."|||23.97|-0.25|
91648425|NCT01406873|183189531|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
91592528|NCT02187471|183075447|SUPERIORITY||Difference in least squares means|0.01|STANDARD_ERROR_OF_MEAN|0.0226||0.6527|TWO_SIDED|95.0|-0.034|0.055|||ANCOVA|||||0.055|-0.034|0.6527
91592529|NCT01206062|183075448|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||Regression, Cox|||||0.89|0.64|<0.001
91648426|NCT03990389|183189535|SUPERIORITY|||||||0.0618||||||Three degrees of freedom for the interaction test|Mixed Models Analysis|||||||0.0618
91648427|NCT03990389|183189535|SUPERIORITY||estimated treatment effect at month 1|-2.29|STANDARD_ERROR_OF_MEAN|1.8||0.63|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.63
91648428|NCT03990389|183189535|SUPERIORITY||estimated treatment effect at month 2|-5.19|STANDARD_ERROR_OF_MEAN|1.9||0.018|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.018
91648429|NCT03990389|183189535|SUPERIORITY||estimated treatment effect at month 3|-3.3|STANDARD_ERROR_OF_MEAN|1.9||0.234|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.234
91648430|NCT03990389|183189536|OTHER|||||||0.116|||||||t-test, 2 sided|||||||0.116
91782560|NCT02304367|183444395|OTHER|||||||0.654|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.654
91592530|NCT01206062|183075449|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.003|TWO_SIDED|95.0|0.6|0.9|||Regression, Cox|||||0.90|0.60|0.003
91592531|NCT01206062|183075450|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.58|TWO_SIDED|95.0|0.34|1.83|||Regression, Cox|||||1.83|0.34|0.58
91782561|NCT02304367|183444395|OTHER|||||||0.579|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.579
91782562|NCT02304367|183444395|OTHER|||||||0.123|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.123
91782563|NCT02304367|183444395|OTHER|||||||0.712|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.712
91782564|NCT02304367|183444395|OTHER|||||||0.258|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.258
91782565|NCT02304367|183444395|OTHER|||||||0.851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.851
91782566|NCT02304367|183444395|OTHER|||||||0.849|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.849
91782567|NCT02304367|183444395|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.153
91782568|NCT02304367|183444396|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.002
91782569|NCT02304367|183444396|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.030
91782570|NCT02304367|183444396|OTHER|||||||0.011|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.011
91782571|NCT02304367|183444396|OTHER|||||||0.186|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.186
91782572|NCT02304367|183444396|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
91782573|NCT02304367|183444396|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.330
91782574|NCT02304367|183444396|OTHER|||||||0.072|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.072
91782575|NCT02304367|183444396|OTHER|||||||0.045|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.045
91782576|NCT02304367|183444397|OTHER|||||||0.369|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.369
91782577|NCT02304367|183444397|OTHER|||||||0.026|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.026
91782578|NCT02304367|183444397|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
91782579|NCT02304367|183444397|OTHER|||||||0.235|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.235
91782580|NCT02304367|183444397|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.009
91782581|NCT02304367|183444397|OTHER|||||||0.278|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.278
91782582|NCT02304367|183444397|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.046
91592532|NCT01206062|183075452|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Cox|||||1.04|0.67|.10
91592533|NCT02318667|183075461|OTHER|||||||0.0074|||||||t-test, 2 sided|||||||0.0074
91592534|NCT02318667|183075462|OTHER|||||||0.1506|||||||t-test, 2 sided|||||||0.1506
91592535|NCT01101438|183075490|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.93
91592536|NCT01101438|183075491|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.17|||Log Rank|||||1.17|0.87|0.94
91592537|NCT01101438|183075492|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.83|1.24|||Log Rank|||||1.24|0.83|0.88
91592538|NCT00709111|183075517|SUPERIORITY_OR_OTHER|||||||0.97||||||The p-value is one-sided with a nominal level of 0.05.|Wilcoxon signed-rank, 1-sided|||The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change \<20 cells/mm\^3. The study was powered to yield 80% power to show that there was \>=20 cells/mm\^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm\^3, a standard deviation of 60 cells/mm\^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.||||0.97
91592539|NCT01735279|183075561|OTHER|Test t Student|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91592540|NCT01735279|183075561|SUPERIORITY||Mean Difference (Final Values)|30.84|||<|0.01|ONE_SIDED|95.0|||||ANOVA|||||||<0.01
91592541|NCT01735279|183075561|SUPERIORITY||Mean Difference (Final Values)|0.002|||<|0.01|TWO_SIDED||||||t-test, 1 sided|||||||<0.01
91592542|NCT01735279|183075561|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.01|ONE_SIDED||||||t-test, 1 sided|||||||<0.01
91592543|NCT00806195|183075562|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines-PRoutine Vaccines) was ≥ 6%.|Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-0.8|6.4|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was \<6%.||6.4|-0.8|
91592544|NCT00806195|183075563|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was ≥5%.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|1.5|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.5|-0.9|
91592545|NCT00806195|183075563|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was \<5%.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.8|1.3|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.3|-0.8|
91521515|NCT00313820|182917478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.36||95.0|-0.7|0.3||Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Paroxysmal Pain Week 12 \[LOCF\]; Modelled Results||0.3|-0.7|0.360
91592546|NCT03634397|183075568|OTHER||Mean Difference (Final Values)|5.73|||<|0.05|TWO_SIDED|95.0|2.31|9.14||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear||The delta values of the outcome from baseline 2 to post-treatment 1 were directly modeled using linear regression with adjustment for age, female sex, and the hemisphere affected by the stroke.|||9.14|2.31|<.05
91592547|NCT03634397|183075570|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Mean Difference (Final Values)|0.83|||<|0.05|TWO_SIDED|95.0|-2.58|4.24||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.||||4.24|-2.58|<.05
91592548|NCT03634397|183075571|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Median Difference (Final Values)|1.12|||<|0.05|TWO_SIDED|95.0|-2.29|4.53||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|||4.53|-2.29|<.05
91648431|NCT00207714|183189541|SUPERIORITY_OR_OTHER|||||||0.01||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.||||0.010
91592549|NCT03901105|183075582|OTHER||Risk Ratio (RR)|1.36||||0.0313|TWO_SIDED|95.0|1.028|1.785||A priori threshold was two-sided 0.05.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline CDR-SB score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.785|1.028|0.0313
91592550|NCT03901105|183075583|OTHER||Risk Ratio (RR)|1.35||||0.0833|TWO_SIDED|95.0|0.962|1.886||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for MMSE CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.886|0.962|.0833
91592551|NCT03901105|183075583|OTHER||Risk Ratio (RR)|1.77||||0.0141|TWO_SIDED|95.0|1.122|2.796||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for ADAS-Cog11 CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.796|1.122|.0141
91592552|NCT03901105|183075583|OTHER||Risk Ratio (RR)|1.32||||0.0639|TWO_SIDED|95.0|0.984|1.776||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for FAQ CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.776|0.984|.0639
91592553|NCT03901105|183075583|OTHER||Risk Ratio (RR)|1.28||||0.2814|TWO_SIDED|95.0|0.815|2.02||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for CDR Global CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.020|0.815|.2814
91592554|NCT03901105|183075584|OTHER|||||||0.0305||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between CDR-SB least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||.0305
91592555|NCT03901105|183075584|OTHER||||||<|0.0001||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between MMSE least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||<0.0001
91592556|NCT03901105|183075584|OTHER|||||||0.0006||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between ADAS-Cog11 least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0006
91592557|NCT03901105|183075584|OTHER|||||||0.0097||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between FAQ least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0097
91592558|NCT00922480|183075590|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
91592559|NCT00922480|183075591|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
91592560|NCT02161575|183075596|SUPERIORITY||Median Difference (Final Values)|-30.75|||<|0.0001|TWO_SIDED|95.0|-59.5|-20.5|||Wilcoxon (Mann-Whitney)|Confidence Interval for the Median Change form Baseline||The null hypothesis was that the change in CSRT from baseline to Day 90 was zero||-20.50|-59.50|<0.0001
91648432|NCT00207714|183189541|SUPERIORITY_OR_OTHER|||||||0.056|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.056
91592561|NCT02446314|183075616|SUPERIORITY||||||=|0.04|||||||Linear Mixed Model / Baseline Covariate|||||||= .04
91592562|NCT02446314|183075617|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
91592563|NCT02446314|183075618|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
91521516|NCT00313820|182917478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.239||95.0|-0.8|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Evoked Pain Week 12 \[LOCF\]; Modelled Results||0.2|-0.8|0.239
91521517|NCT00313820|182917478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.118||95.0|-1.0|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||P/D Week 12 \[LOCF\]; Modelled Results||0.1|-1.0|0.118
91521518|NCT00313820|182917478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.87||0.138||95.0|-6.5|0.9||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Total Score Week 12 \[LOCF\]; Modelled Results||0.9|-6.5|0.138
91521519|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|2.79||0.086||95.0|-10.3|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep disturbance; Modelled Results||0.7|-10.3|0.086
91521520|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|3.72||0.039||95.0|0.4|15.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Snoring score; Modelled Results||15.1|0.4|0.039
91521521|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|2.71||0.169||95.0|-9.1|1.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Awaken SOB or headache; Modelled Results||1.6|-9.1|0.169
91521522|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03||95.0|0.0|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep quantity; Modelled Results||0.7|0.0|0.030
91521523|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|3.44||0.013||95.0|1.8|15.4||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep adequacy; Modelled Results||15.4|1.8|0.013
91521524|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.51||0.399||95.0|-2.8|7.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Somnolence; Modelled Results||7.1|-2.8|0.399
91521525|NCT00313820|182917479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.13||0.049||95.0|-8.4|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Overall sleep problems index; Modelled Results||-0.0|-8.4|0.049
91521526|NCT00313820|182917480|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.5||0.201||95.0|0.8|2.9||Estimated from a logistic regression model with treatment and the baseline assessment as factors.|Regression, Logistic||Standard error of the mean = standard error of the odds ratio.|Modelled Results||2.9|0.8|0.201
91521527|NCT00313820|182917481|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.015||95.0|-1.8|-0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Anxiety score; Modelled Results||-0.2|-1.8|0.015
91521528|NCT00313820|182917481|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.6||95.0|-0.6|1.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Depression score; Modelled Results||1.0|-0.6|0.600
91521529|NCT00313820|182917482|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.566||95.0|-0.1|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||0.1|-0.1|0.566
91521530|NCT00313820|182917483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.47||0.22||95.0|-1.8|7.9||Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||7.9|-1.8|0.220
91521531|NCT00313820|182917484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.144||95.0|-0.5|0.1||Estimated from ANCOVA (general linear model) with treament and country as factors.|ANCOVA|||Modelled Results||0.1|-0.5|0.144
91521532|NCT00313820|182917485|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.049||95.0|-0.6|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors.|ANCOVA|||Modelled Results||-0.0|-0.6|0.049
91521533|NCT00251862|182917488|SUPERIORITY_OR_OTHER||Absolute Difference|8.3||||0.046|TWO_SIDED|95.0|-2.2|14.2|||Chi-squared|||Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P\<0.05 level.||14.2|-2.2|0.046
91521534|NCT00251862|182917488|SUPERIORITY_OR_OTHER||Absolute Difference|6.0||||0.153|TWO_SIDED|95.0|0.2|16.5|||Chi-squared|||||16.5|0.2|0.153
91521535|NCT00251862|182917489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons: DA+YDR vs. Control, P\<0.001; DA alone vs. Control, P\<0.001|ANCOVA|||The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
91521536|NCT00251862|182917490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
91521537|NCT00251862|182917491|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
91592564|NCT02446314|183075619|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
91521538|NCT02453685|182917492|SUPERIORITY_OR_OTHER||Treatment difference at week 32|0.18||||0.0435|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis||"'Treatment difference' refers to BIAsp 30 minus Basal-bolus"|Analysis was performed using mixed model repeated measurements including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix.||0.36|0.01|0.0435
91521539|NCT01515748|182917509|SUPERIORITY|||||||0.0152||||||Threshold for statistical significance at 0.049.|Stratified Log Rank|||Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).||||0.0152
91521540|NCT02597907|182917606|OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
91521541|NCT00949715|182917607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.2352|TWO_SIDED|95.0|-2.7|10.8|||t-test, 2 sided|||HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.||10.8|-2.7|0.2352
91521542|NCT00949715|182917608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.7405|TWO_SIDED|95.0|-7.6|5.5|||t-test, 2 sided|||Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.||5.5|-7.6|0.7405
91521543|NCT00949715|182917609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3||||0.1051|TWO_SIDED|95.0|-25.1|2.4|||t-test, 2 sided|||Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volume||2.4|-25.1|0.1051
91521544|NCT00949715|182917610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.9||||0.9835||95.0||||Adjusting for age and gender|Wilcoxon (Mann-Whitney)|Rank Sum||Ho: The AT/AF burden in the RVS group is the same as the RVA group.||||0.9835
91521545|NCT05050578|182917627|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference = LID18869 minus AOHG. Sign is retained with the rounded value.|||0.00||
91521546|NCT00990964|182917632|SUPERIORITY_OR_OTHER||One sample proportion|0.94|||||TWO_SIDED|95.0|0.929|0.951||||||||.951|.929|
91521547|NCT00990964|182917633|SUPERIORITY_OR_OTHER||One sample proportion|0.974|||||TWO_SIDED|95.0|0.965|0.98||||||||.980|.965|
91521548|NCT03386032|182917645|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means.||Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.||||<0.05
91521549|NCT03386032|182917646|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means. Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left miss||"Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.~Significance level: 0.05 (2-sided)"||||<0.05
91521550|NCT04082442|182917662|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||.0001
91521551|NCT04082442|182917663|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||.34
91521552|NCT04525547|182917665|OTHER|||||||0.817|||||||t-test, 2 sided|||||||0.8170
91521553|NCT04525547|182917666|OTHER|||||||0.6533|||||||t-test, 2 sided|||||||0.6533
91521554|NCT01493687|182917691|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91521555|NCT01493687|182917692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.13|||<|0.001|TWO_SIDED|95.0|-10.12|-6.13|||ANCOVA|||||-6.13|-10.12|<0.001
91521556|NCT01493687|182917693|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91521557|NCT01783418|182917695|SUPERIORITY_OR_OTHER|||||||0.613|TWO_SIDED||||||ANOVA|||Baseline and Post-intervention (8 weeks)||||0.613
91521558|NCT01783418|182917696|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.957
91521559|NCT01783418|182917697|SUPERIORITY_OR_OTHER|||||||0.256|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||.256
91521560|NCT01783418|182917698|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.97
91521561|NCT01783418|182917699|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention||||0.241
91592565|NCT02446314|183075620|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
91592566|NCT01671111|183075630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.0560
91592567|NCT01671111|183075631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1232
91592568|NCT01671111|183075632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1319|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1319
91592569|NCT01671111|183075633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.8061
91592570|NCT01671111|183075634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2297|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.2297
91592571|NCT01671111|183075635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1248|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.1248
91592572|NCT00545064|183075660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.001||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 score = 7"||7.0|-0.6|0.001
91592573|NCT00545064|183075660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.097||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 = 0"||7.0|-0.6|0.097
91592574|NCT00545064|183075663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = -4"||-10.7|-12.3|<0.001
91592575|NCT00545064|183075663|SUPERIORITY_OR_OTHER||Median Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = 0"||-10.7|-12.3|<0.001
91592576|NCT04376827|183075751|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.7807|TWO_SIDED|80.0|0.27|1.41|||log-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||1.41|0.27|0.7807
91592577|NCT04376827|183075752|SUPERIORITY||Hazard Ratio (HR)|1.52||||0.4654|TWO_SIDED|80.0|0.62|3.85|||long-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||3.85|0.62|0.4654
91592578|NCT01798589|183075808|OTHER|Bioequivalence is assessed based on concordance between the 2 allergen using Kappa statistic|Concordance|66.7|||||TWO_SIDED|95.0|41.6|90.2||||||||90.2|41.6|
91592579|NCT00139776|183075861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||"Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.~Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level."||||<0.0001
91592580|NCT00139776|183075862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|Log Rank|||Kaplan-Meier analysis||||<0.0001
91521562|NCT01783418|182917700|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.358
91592581|NCT00139776|183075863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
91521563|NCT01783418|182917701|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.95
91592582|NCT00139776|183075864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
91592583|NCT00139776|183075865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
91592584|NCT00139776|183075865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||<0.001
91592585|NCT00139776|183075865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||<0.001
91592586|NCT00139776|183075865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.003
91648433|NCT00207714|183189541|SUPERIORITY_OR_OTHER|||||||0.281|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.281
91648434|NCT00207714|183189541|SUPERIORITY_OR_OTHER|||||||0.119|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.119
91592587|NCT00139776|183075865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.022
91592588|NCT00139776|183075865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.047
91592589|NCT00139776|183075866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
91592590|NCT00139776|183075866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||0.001
91592591|NCT00139776|183075866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||0.096
91592592|NCT00139776|183075866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.338
91592593|NCT00139776|183075866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.832||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.832
91592594|NCT00139776|183075866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.972
91592595|NCT00139776|183075867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046||95.0||||Overall p-value Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.0046
91592596|NCT00139776|183075868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0102
91592597|NCT00139776|183075869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0012
91592598|NCT00139776|183075870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
91592599|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Total WOMAC score||||<0.001
91592600|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.71||||95.0|0.21|2.99|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Continuous use||2.99|0.21|
91648435|NCT00207714|183189541|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||<0.001
91592601|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.99|STANDARD_ERROR_OF_MEAN|0.71||||95.0|3.6|6.38|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Intermittent use||6.38|3.60|
91592602|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
91592603|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.06|0.67|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Continuous use||0.67|0.06|
91648436|NCT00207714|183189542|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.||||0.001
91648437|NCT00207714|183189542|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks||||0.006
91648438|NCT00207714|183189542|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks||||0.095
91592604|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.88|1.49|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Intermittent use||1.49|0.88|
91592605|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||0.004
91648439|NCT00207714|183189542|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA on van der Waerden normal scores.|ANOVA on van der Waerden normal scores||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks||||0.010
91648440|NCT00207714|183189542|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks||||<0.001
91648441|NCT02595528|183189543|SUPERIORITY||Least Squares (LS)|-2.5543||||0.0029|||||||Mixed model for repeated measures|||AGN-190584 Quadratic||||0.0029
91648442|NCT02595528|183189543|SUPERIORITY||Least Squares (LS)|6.6961|||<|0.0001|||||||Mixed model for repeated measures|||AGN-190584 Linear||||<0.0001
91648443|NCT02595528|183189543|SUPERIORITY||Least Squares (LS)|-69.89||||0.4126|||||||Mixed model for repeated measures|||AGN-199201 Quadratic||||0.4126
91648444|NCT02595528|183189543|SUPERIORITY||Least Squares (LS)|10.5017||||0.3752|||||||Mixed model for repeated measures|||AGN-199201 Linear||||0.3752
91648445|NCT03202511|183189544|EQUIVALENCE|0.8 to 1.25 equivalence margin was used.|Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.47|1.77||||||||1.77|1.47|
91648446|NCT03202511|183189545|EQUIVALENCE|80 to 125% equivalence margin was used.|Geometric Mean Ratio|77.4|||||TWO_SIDED|90.0|61.4|97.6||||||||97.6|61.4|
91648447|NCT02082912|183189564|SUPERIORITY||F statistic|0.216||||0.651|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.651
91648448|NCT02082912|183189565|SUPERIORITY||F statistic|0.633||||0.447|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.447
91648449|NCT02082912|183189566|SUPERIORITY||F statistic|0.557||||0.471|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.471
91782583|NCT02304367|183444397|OTHER|||||||0.035|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.035
91782584|NCT02304367|183444398|OTHER|||||||0.442|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.442
91782585|NCT02304367|183444398|OTHER|||||||0.677|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.677
91782586|NCT02304367|183444398|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.027
91782587|NCT02304367|183444398|OTHER|||||||0.42|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.420
91782588|NCT02304367|183444398|SUPERIORITY|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
91782589|NCT02304367|183444398|OTHER|||||||0.312|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.312
91782590|NCT02304367|183444398|OTHER|||||||0.249|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.249
91782591|NCT02304367|183444398|OTHER|||||||0.102|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.102
91782592|NCT02304367|183444399|OTHER|||||||0.856|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.856
91782593|NCT02304367|183444399|OTHER|||||||0.898|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.898
91782594|NCT02304367|183444399|OTHER|||||||0.785|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.785
91782595|NCT02304367|183444399|OTHER|||||||0.932|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.932
91782596|NCT02304367|183444399|OTHER|||||||0.545|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.545
91782597|NCT02304367|183444399|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.580
91782598|NCT02304367|183444399|OTHER|||||||0.462|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.462
91648450|NCT00782275|183189571|SUPERIORITY|||||||0.081|||||||exact binomial test|||The regimen was evaluated against an historical control with null and alternative 4-month PFS rates of 50% and 70%, respectively. With the final sample size of 40 eligible patients and using the same operating characteristics (alpha and beta 10%), the decision rule changes such that if 25 or more patients of 40 are alive and progression-free at 4 months then this regimen is considered promising.||||0.081
91648451|NCT04378010|183189575|OTHER||LS mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.788||0.454|TWO_SIDED|95.0|-3.479|7.239|||Mixed model repeated measures|||||7.239|-3.479|0.454
91648452|NCT04378010|183189575|OTHER||LS mean difference|-0.439|STANDARD_ERROR_OF_MEAN|1.553||0.848|TWO_SIDED|95.0|-5.458|4.579|||Mixed model repeated measures|||||4.579|-5.458|0.848
91648453|NCT04378010|183189586|OTHER||LS mean difference|-11.718|STANDARD_ERROR_OF_MEAN|7.052||0.114|TWO_SIDED|95.0|-26.342|2.906|||ANCOVA|||||2.906|-26.342|0.114
91648454|NCT04378010|183189586|OTHER||LS mean difference|-11.261|STANDARD_ERROR_OF_MEAN|6.879||0.099|TWO_SIDED|95.0|-24.723|2.2|||ANCOVA|||||2.200|-24.723|0.099
91648455|NCT04378010|183189587|OTHER||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|0.331||0.003|TWO_SIDED|95.0|0.365|1.736|||ANCOVA|||||1.736|0.365|0.003
91648456|NCT04378010|183189587|OTHER||LS mean difference|0.591|STANDARD_ERROR_OF_MEAN|0.315||0.064|TWO_SIDED|95.0|-0.035|1.216|||ANCOVA|||||1.216|-0.035|0.064
91648457|NCT04378010|183189591|OTHER||LS mean difference|12.986|STANDARD_ERROR_OF_MEAN|5.472||0.04|TWO_SIDED|95.0|0.608|25.363|||Mixed model repeated measures|||||25.363|0.608|0.040
91521564|NCT00508261|182917710|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.64|||||TWO_SIDED|95.0|-0.33|4.71||||||Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.||4.71|-0.33|
91648458|NCT04378010|183189591|OTHER||LS mean difference|7.211|STANDARD_ERROR_OF_MEAN|5.724||0.242|TWO_SIDED|95.0|-4.997|19.418|||Mixed model repeated measures|||||19.418|-4.997|0.242
91648459|NCT00747747|183189625|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypothesis: no difference among groups.||||<0.05
91648460|NCT00747747|183189630|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypotheis: no difference among the groups.||||<0.05
91648461|NCT02919475|183189639|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
91648462|NCT02919475|183189639|SUPERIORITY|||||||0.841|||||||Fisher Exact|||||||0.841
91648463|NCT02919475|183189639|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
91648464|NCT02919475|183189639|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91648465|NCT02919475|183189640|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91648466|NCT02919475|183189640|SUPERIORITY|||||||0.832|||||||Fisher Exact|||||||0.832
91648467|NCT02919475|183189640|SUPERIORITY|||||||0.682|||||||Fisher Exact|||||||0.682
91648468|NCT02919475|183189640|SUPERIORITY|||||||0.665|||||||Fisher Exact|||||||0.665
91648469|NCT02919475|183189641|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91648470|NCT02919475|183189641|SUPERIORITY|||||||0.627|||||||Fisher Exact|||||||0.627
91648471|NCT02919475|183189641|SUPERIORITY|||||||0.794|||||||Fisher Exact|||||||0.794
91648472|NCT02919475|183189641|SUPERIORITY|||||||0.453|||||||Fisher Exact|||||||0.453
91648473|NCT02919475|183189642|SUPERIORITY|||||||0.113|||||||Fisher Exact|||||||0.113
91648474|NCT02919475|183189642|SUPERIORITY|||||||0.024|||||||Fisher Exact|||||||0.024
91648475|NCT02919475|183189642|SUPERIORITY|||||||0.056|||||||Fisher Exact|||||||0.056
91648476|NCT02919475|183189642|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
91648477|NCT01928446|183189649|SUPERIORITY||Cox Proportional Hazard|1.1||||0.61|TWO_SIDED|95.0|0.77|1.55|||Log Rank|||Model1 - Treatment only: unadjusted for other covariates||1.55|0.77|0.61
91648478|NCT01928446|183189649|SUPERIORITY||Cox Proportional Hazard|1.08||||0.67|TWO_SIDED|95.0|0.76|1.53|||Log Rank|||Model2 - Treatment only: unadjusted with Site as random Effect||1.53|0.76|0.67
91648479|NCT01928446|183189650|SUPERIORITY||Cox Proportional Hazard|1.49||||0.37|TWO_SIDED|95.0|0.61|3.64|||Log Rank|||||3.64|0.61|0.37
91648480|NCT01928446|183189651|SUPERIORITY||Cox Proportional Hazard|1.14||||0.77|TWO_SIDED|95.0|0.48|2.69|||Log Rank|||Model 5: Non-fatal self-directed violence subgroup||2.69|0.48|0.77
91648481|NCT01928446|183189651|SUPERIORITY||Cox Proportional Hazard|1.61||||0.22|TWO_SIDED|95.0|0.75|3.43|||Log Rank|||Model 6: Interrupted self-directed violence subgroup||3.43|0.75|0.22
91648482|NCT01928446|183189651|SUPERIORITY||Cox Proportional Hazard|0.92||||0.71|TWO_SIDED|95.0|0.58|1.45|||Log Rank|||Model 7: Hospitalization to prevent suicide||1.45|0.58|0.71
91648483|NCT04356573|183189693|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91648484|NCT01577537|183189694|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91648485|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-3.2||||0.008|TWO_SIDED|95.0|-5.6|-0.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.8|-5.6|0.008
91648486|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.3|||<|0.001|TWO_SIDED|95.0|-7.7|-2.9||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-2.9|-7.7|<0.001
91592606|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.02|0.25|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Continuous use||0.25|-0.02|
91592607|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.07||||95.0|0.26|0.53|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Intermittent use||0.53|0.26|
91592608|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||0.002
91592609|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.51||||95.0|0.13|2.14|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Continuous use||2.14|0.13|
91592610|NCT00139776|183075871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.43|STANDARD_ERROR_OF_MEAN|0.51||||95.0|2.42|4.43|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Intermittent use||4.43|2.42|
91592611|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2712||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep disturbance||||0.2712
91592612|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Snoring||||0.8737
91592613|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7703||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Awaken short of breath||||0.7703
91592614|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Quantity of sleep||||0.3769
91592615|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4075||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep adequacy||||0.4075
91592616|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5854||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Somnolence||||0.5854
91592617|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8358||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index I||||0.8358
91592618|NCT00139776|183075872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5878||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index II||||0.5878
91592619|NCT00139776|183075873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC total score||||<0.001
91592620|NCT00139776|183075873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
91592621|NCT00139776|183075873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||<0.001
91592622|NCT00139776|183075873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||<0.001
91592623|NCT00139776|183075874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1437||95.0||||Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|by general association||Analysis across all 3 sleep scores for Period III||||0.1437
91592624|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical function||||<0.0001
91592625|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role physical||||<0.0001
91592626|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Bodily pain||||<0.0001
91592627|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||General health||||0.3097
91592628|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Vitality||||0.0139
91592629|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1303||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Social functioning||||0.1303
91592630|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role emotional||||0.1404
91592631|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4015||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental health||||0.4015
91592632|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical component summary||||<0.0001
91592633|NCT00139776|183075875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0301||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental component summary||||0.0301
91592634|NCT04223843|183075887|OTHER||Difference of adjusted means|0.336|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.246|0.425|||ANCOVA|Model included fixed categorical effects of treatment and the fixed continous effect of baseline FEV1 AUC0-3.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3 change from baseline between Tio+Olo and matching placebo.||0.425|0.246|<0.0001
91592635|NCT04223843|183075887|OTHER||Difference of adjusted means|0.321|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.233|0.409|||ANCOVA|Model included the fixed categorical effect of treatment and the fixed continuous effect of baseline FEV1 AUC0-3h.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3h change from baseline between Tio+Olo and matching placebo.||0.409|0.233|<0.0001
91782599|NCT02304367|183444399|OTHER|||||||0.26|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.260
91592636|NCT04223843|183075888|OTHER||Difference of adjusted means|0.201|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.117|0.286|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.286|0.117|<0.0001
91592637|NCT04223843|183075888|OTHER||Difference of adjusted means|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.135|0.299|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.299|0.135|<0.0001
91592638|NCT01970488|183075895|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.|Least Squares (LS) Mean Difference|-2.18|||||TWO_SIDED|95.0|-7.39|3.02||||||||3.02|-7.39|
91592639|NCT00509067|183075936|SUPERIORITY|||||||0.93||||||alpha set at P \< .05|Mixed Models Analysis|Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.||||||0.93
91592640|NCT00509067|183075937|SUPERIORITY|||||||0.23||||||alpha level set at .05|Mixed Models Analysis|Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..||||||0.23
91592641|NCT00509067|183075937|SUPERIORITY|||||||0.23||||||alpha set at P\<0.05|Mixed Models Analysis|Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.||||||0.23
91592642|NCT01286454|183075938|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.23|||||TWO_SIDED|90.0|102.69|120.47||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||120.47|102.69|
91592643|NCT01286454|183075938|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.07|||||TWO_SIDED|90.0|95.16|111.64||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||111.64|95.16|
91592644|NCT01286454|183075938|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|70.36|||||TWO_SIDED|90.0|64.52|76.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||76.74|64.52|
91592645|NCT01286454|183075938|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|113.55|||||TWO_SIDED|90.0|105.91|121.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||121.74|105.91|
91592646|NCT01286454|183075939|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|112.8|||||TWO_SIDED|90.0|103.85|122.52||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||122.52|103.85|
91709195|NCT01402986|183311343|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.904|TWO_SIDED|95.0|0.71|1.46|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \> 2 but =\< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.46|0.71|0.904
91592647|NCT01286454|183075939|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.71|||||TWO_SIDED|90.0|95.48|112.65||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||112.65|95.48|
91592648|NCT01286454|183075939|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|66.87|||||TWO_SIDED|90.0|61.56|72.63||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||72.63|61.56|
91592649|NCT01286454|183075939|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|28.34|||||TWO_SIDED|90.0|26.09|30.78||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||30.78|26.09|
91592650|NCT01286454|183075939|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|114.7|||||TWO_SIDED|90.0|106.99|122.97||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||122.97|106.99|
91592651|NCT01286454|183075940|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|259.4|||||TWO_SIDED|90.0|231.48|290.7||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||290.70|231.48|
91592652|NCT01286454|183075940|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|134.83|||||TWO_SIDED|90.0|120.31|151.09||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||151.09|120.31|
91592653|NCT01286454|183075940|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|48.58|||||TWO_SIDED|90.0|43.35|54.44||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||54.44|43.35|
91592654|NCT01286454|183075940|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|14.38|||||TWO_SIDED|90.0|12.83|16.11||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||16.11|12.83|
91592655|NCT01286454|183075940|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|171.06|||||TWO_SIDED|90.0|115.82|187.78||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||187.78|115.82|
91592656|NCT01898689|183075943|EQUIVALENCE|The a priori equivalence region for the difference in means between the two concentrations was specified as +10 mA. This value was considered the minimal clinically relevant current since it approximates the tolerated electrical current range at baseline of the general population-in other words, natural variability and therefore a relatively small amount of current to detect.|Mean Difference (Net)|0.2||||0.02|TWO_SIDED|90.0|-8.2|8.5||"P-values from the TOST procedure were 0.02 and 0.03 for the mean being inside the lower and upper boundaries, respectively.~(estimated mean difference of 0.2 mA; 90% CI 28.2 to 8.5)"|Mixed Models Analysis|||"The null and alternative hypotheses were thus:~H0: m0.1%-m0.4% ≤ -10 or m0.1%-m0.4% ≥ 10 and Ha: -10 , m0.1%-m0.4% , 10 where m0.1% and m0.1% are the population means for tolerance to current under 0.1% and 0.4% ropivacaine, respectively.~With 24 evaluable subjects, we had 90% power at the 0.05 significance level to detect equivalence of 0.1% and 0.4% ropivacaine concentration on the mean tolerance to transcutaneous electrical stimulation"||8.5|-8.2|0.02
91592657|NCT01289821|183075976|SUPERIORITY_OR_OTHER||Percentage of Participants|43.9||||0.36|TWO_SIDED|80.0|33.19|55.09|||One-sample exact binomial test|||"Null hypothesis: True probability p of objective tumor response does not exceed p0, p0=0.4. H0: p\<=0.4 One-sided type I error probability of alpha=10%"||55.09|33.19|0.36
91648487|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.2|||<|0.001|TWO_SIDED|95.0|-8.6|-3.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-3.8|-8.6|<0.001
91648488|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.92|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 1 (Placebo\<2.5 mg=5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 1. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
91782600|NCT00573144|183444402|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
91592658|NCT02887404|183075985|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.92|TWO_SIDED|95.0|-6.0|6.0|||t-test, 2 sided|||||6|-6|0.92
91592659|NCT02887404|183075986|NON_INFERIORITY|Delta: 15. The significance level for non-inferiority was 0.025|Median Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-21.0|3.0|||Hodges-Lehmann estimator|||||3|-21|<0.001
91592660|NCT02887404|183075986|SUPERIORITY||Median Difference (Final Values)|-9.0||||0.175|TWO_SIDED|97.5|-23.0|5.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice.|Hodges-Lehmann estimator|||||5|-23|0.175
91592661|NCT02887404|183075987|NON_INFERIORITY|Delta: 1 The significance level for the non-inferiority test was 0.025.|Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.8|1.0||This is a joint hypothesis testing. We tested non-inferiority on both secondary outcomes. If both showed significant non-inferiority, we tested superiority on both outcomes.|Regression, Linear|||||1|-0.8|<0.001
91592662|NCT02887404|183075987|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.094|TWO_SIDED|97.5|-0.8|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.1|-0.8|0.094
91592663|NCT02887404|183076005|NON_INFERIORITY|Delta: 9; significance level was 0.025|Median Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.1|||Wilcoxon (Mann-Whitney)|||||0.1|-0.3|<0.001
91592664|NCT02887404|183076005|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.171|TWO_SIDED|97.5|-0.3|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Wilcoxon sum rank test|||||0.1|-0.3|0.171
91592665|NCT02887404|183076006|NON_INFERIORITY|Delta: 1 significance level: 0.025|Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.0|-0.1|||Regression, Linear||||The superiority test (this is a joint-hypothesis testing) showed a mean difference of -0.5 between treatment and control group with 97.5% CI of (-1.0, 0.0) and p-value of 0.025. The significance level was 0.025.|-0.1|-1.0|<0.001
91592666|NCT02887404|183076006|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|97.5|-1.0|0.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.0|-1.0|0.025
91592667|NCT01022242|183076007|SUPERIORITY_OR_OTHER|||||||0.8861|||||||ANCOVA|||||||0.8861
91592668|NCT02243865|183076008|SUPERIORITY|||||||0.6938|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||||||0.6938
91648489|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.87|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 2 (Placebo=2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 2. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
91592669|NCT02243865|183076009|SUPERIORITY|||||||0.6557|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation duration||||0.6557
91592670|NCT02243865|183076009|SUPERIORITY|||||||0.515|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration||||0.515
91592671|NCT02243865|183076009|SUPERIORITY|||||||0.3256|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration||||0.3256
91592672|NCT02243865|183076009|SUPERIORITY|||||||0.4086|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration.||||0.4086
91592673|NCT03654976|183076017|SUPERIORITY||Rate ratio|0.89||||0.5412|TWO_SIDED|95.0|0.6|1.31|||Negative binomial regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The number of clinically relevant asthma exacerbations was analyzed using a negative binomial regression model with a log-link function and the logarithm of the time in years in the efficacy period as offset. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||1.31|0.60|0.5412
91592674|NCT03654976|183076018|SUPERIORITY||Odds Ratio (OR)|0.7713||||0.4156|TWO_SIDED|95.0|0.41|1.44|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.44|0.41|0.4156
91592675|NCT03654976|183076019|SUPERIORITY||Odds Ratio (OR)|0.8477||||0.4146|TWO_SIDED|95.0|0.57|1.26|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit is included as a covariate. No missing data approach was applied.||1.26|0.57|0.4146
91782601|NCT00573144|183444403|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
91782602|NCT00573144|183444404|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
91592676|NCT03654976|183076020|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8829|TWO_SIDED|95.0|-1.47|1.7|||Mixed-effect model repeated measurement||12 SQ-HDM - placebo|A 'mixed-effect model repeated measurement' model was analysed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.70|-1.47|0.8829
91592677|NCT03654976|183076021|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0044|TWO_SIDED|95.0|1.29|3.96|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analyzed using a generalized linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||3.96|1.29|0.0044
91592678|NCT03654976|183076022|SUPERIORITY||Odds Ratio, log|1.62||||0.0698|TWO_SIDED|95.0|0.96|2.74|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||2.74|0.96|0.0698
91592679|NCT00117598|183076025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.25|0.63|||Log Rank||HR from a cox model adjusted for baseline stratification factors|Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator's choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.||0.63|0.25|<0.0001
91592680|NCT00117598|183076025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.65|0.26|<0.0001
91592681|NCT00117598|183076026|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Fisher Exact|||||||0.0019
91592682|NCT00117598|183076026|SUPERIORITY_OR_OTHER|||||||0.6179|TWO_SIDED||||||Fisher Exact|||||||0.6179
91592683|NCT00117598|183076027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3053|TWO_SIDED|95.0|0.46|1.28|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.28|0.46|0.3053
91592684|NCT00117598|183076027|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.9515|TWO_SIDED|95.0|0.6|1.62|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.62|0.60|0.9515
91592685|NCT00117598|183076028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.14|9.01|||||HR from a cox model adjusted for baseline stratification factors|||9.01|0.14|
91592686|NCT00117598|183076028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.1|13.3|||||HR from a cox model adjusted for baseline stratification factors|||13.3|0.10|
91592687|NCT00117598|183076030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.56|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.56|0.23|<0.0001
91592688|NCT00117598|183076030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.26|0.6|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.60|0.26|<0.0001
91709196|NCT01402986|183311360|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.293|TWO_SIDED|95.0|0.26|1.51|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.51|0.26|0.293
91592689|NCT00117598|183076031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0004|TWO_SIDED|95.0|0.23|0.67|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.67|0.23|0.0004
91592690|NCT00117598|183076031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0712|TWO_SIDED|95.0|0.4|1.04|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.04|0.40|0.0712
91592691|NCT01500525|183076046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0|||<|0.05|ONE_SIDED|95.0|||||Regression, Cox|||||||<0.05
91592692|NCT01660451|183076047|SUPERIORITY_OR_OTHER_LEGACY||Response rate|45.45||||0.0001|TWO_SIDED|90.0|30.49|61.06||0.0001|Exact binomial test|||Response rate was statistically compared by exact binomial test if higher than 5%.||61.06|30.49|0.0001
91592693|NCT01660451|183076047|SUPERIORITY_OR_OTHER_LEGACY||Response rate|27.08||||0.0001|TWO_SIDED|90.0|16.83|39.57||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.||39.57|16.83|0.0001
91592694|NCT01660451|183076048|SUPERIORITY_OR_OTHER_LEGACY||Response rate|59.15|||<|0.0001|TWO_SIDED|95.0|50.6|67.32||0.001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||67.32|50.60|<0.0001
91592695|NCT01660451|183076049|SUPERIORITY_OR_OTHER_LEGACY||Response rate|46.88||||0.0001|TWO_SIDED|90.0|31.54|62.66||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||62.66|31.54|0.0001
91592696|NCT01660451|183076049|SUPERIORITY_OR_OTHER_LEGACY||Response rate|31.25||||0.0001|TWO_SIDED|90.0|20.35|43.97||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||43.97|20.35|0.0001
91592697|NCT01660451|183076050|SUPERIORITY_OR_OTHER_LEGACY||Response rate|51.41||||0.0039|TWO_SIDED|95.0|42.88|59.87||0.01|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||59.87|42.88|0.0039
91592698|NCT01660451|183076061|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|1.0|||||TWO_SIDED|95.0|0.5|2.5||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||2.5|0.5|
91592699|NCT01660451|183076062|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|0.5|||||TWO_SIDED|95.0|-0.7|3.2||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||3.2|-0.7|
91592700|NCT04688775|183076063|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5048|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Repeated Measures|||Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebo||2.6|-1.3|0.5048
91592701|NCT04688775|183076068|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0772|TWO_SIDED|95.0|0.96|2.17|||Regression, Cox|||||2.17|0.96|0.0772
91592702|NCT00074581|183076096|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22|||Regression, Cox||The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.|||0.22|0.02|<0.0001
91592703|NCT00074581|183076097|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.19|0.53|||Regression, Cox||The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.|||0.53|0.19|<0.0001
91592704|NCT01536951|183076136|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.239|||||TWO_SIDED|90.0|-1.65|2.12|||||LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.12|-1.65|
91592705|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||||TWO_SIDED|90.0|-0.079|3.69|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.69|-0.0790|
91592706|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|||||TWO_SIDED|90.0|-0.446|3.32|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.32|-0.446|
91592707|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|0.468|||||TWO_SIDED|90.0|-1.42|2.35|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.35|-1.42|
91592708|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|0.702|||||TWO_SIDED|90.0|-1.18|2.59|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.59|-1.18|
91592709|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|||||TWO_SIDED|90.0|-2.68|1.1|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||1.10|-2.68|
91709197|NCT01402986|183311360|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.27|TWO_SIDED|95.0|0.27|1.44|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.44|0.27|0.270
91592710|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|90.0|-0.182|3.6|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.60|-0.182|
91592711|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|0.963|||||TWO_SIDED|90.0|-0.921|2.85|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.85|-0.921|
91592712|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|90.0|10.0|14.5|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||14.5|10.0|
91592713|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|11.0|||||TWO_SIDED|90.0|8.74|13.3|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.3|8.74|
91592714|NCT01536951|183076136|SUPERIORITY_OR_OTHER||LS mean difference|11.1|||||TWO_SIDED|90.0|8.87|13.4|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.4|8.87|
91592715|NCT01843972|183076141|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|97.88|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|79.963|119.809|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||119.809|79.963|
91592716|NCT01843972|183076141|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|111.2|STANDARD_DEVIATION|24.7|||TWO_SIDED|90.0|88.596|139.576|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||139.576|88.596|
91709198|NCT01402986|183311361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.257|TWO_SIDED|95.0|0.57|1.16|||Regression, Cox|||||1.16|0.57|0.257
91592717|NCT01843972|183076142|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|101.31|STANDARD_DEVIATION|28.2|||TWO_SIDED|90.0|80.593|127.351|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||127.351|80.593|
91592718|NCT01843972|183076142|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|92.69|STANDARD_DEVIATION|33.0|||TWO_SIDED|90.0|68.662|125.119|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||125.119|68.662|
91592719|NCT01843972|183076143|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0233|||||TWO_SIDED|95.0|0.8265|1.2201|||Regression, Linear|||||1.2201|0.8265|
91592720|NCT01843972|183076144|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|0.9686|||||TWO_SIDED|95.0|0.8107|1.1266|||Regression, Linear|||Dose proportionality of BI 691751 was explored using a power model (regression model applied to log-transformed data).||1.1266|0.8107|
91648490|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-3.4||||0.0021||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 3 (Placebo=2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 3. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||0.0021
91709199|NCT01402986|183311361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.225|TWO_SIDED|95.0|0.56|1.15|||Regression, Cox|||||1.15|0.56|0.225
91709200|NCT01402986|183311362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.538|TWO_SIDED|95.0|0.37|1.68|||Regression, Cox|||||1.68|0.37|0.538
91709201|NCT01402986|183311362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.561|TWO_SIDED|95.0|0.37|1.71|||Regression, Cox|||||1.71|0.37|0.561
91592721|NCT01843972|183076145|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|95.48|STANDARD_DEVIATION|30.8|||TWO_SIDED|90.0|74.414|122.511|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||122.511|74.414|
91648491|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.28|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 4 (Placebo\<2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 4. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
91648492|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.64|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 5 (Placebo=2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 5. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
91648493|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.07|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 6 (Placebo\<2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 6. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
91648494|NCT01244815|183189699|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.49|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 7 (Placebo\<2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 7. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
91648495|NCT01244815|183189700|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.3|-0.9|<0.001
91648496|NCT01244815|183189700|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-0.9|<0.001
91648497|NCT01244815|183189700|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-1.0|<0.001
91592722|NCT01843972|183076145|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|84.376|142.894|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||142.894|84.376|
91592723|NCT01843972|183076145|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0312|||||TWO_SIDED|95.0|0.833|1.179|||Regression, Linear|||||1.1790|0.833|
91592724|NCT02774616|183076152|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0004|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0004
91592725|NCT02774616|183076153|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0019|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0019
91592726|NCT02774616|183076155|NON_INFERIORITY|This endpoint evaluates the rate of appropriate right ventricular sensing of all patients in which a sensing measurement was performed. The following hypothesis has been defined: Ho: Rate of appropriate sensing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate sensing through 3 months post-implant \> 93.0%|||||<|0.0001||||||A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate sensing is greater than 93.0% in the population.|exact binomial|||||||<0.0001
91592727|NCT02774616|183076156|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate pacing is greater than 93.0% in the population.|||||<|0.0001|||||||exact binomial|||"This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant \> 93.0%"||||<0.0001
91592728|NCT00545402|183076165|SUPERIORITY_OR_OTHER|||||||0.2611|||||||Log Rank|||||||0.2611
91592729|NCT00545402|183076167|SUPERIORITY_OR_OTHER|||||||0.7091|||||||Log Rank|||||||0.7091
91592730|NCT00382018|183076170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.69|1.47|||Log Rank|||Hazard Ration of overall survival compared Arm C2 to Arm C1.||1.47|0.69|0.98
91592731|NCT00382018|183076171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.64|TWO_SIDED|95.0|0.64|1.32|||Log Rank|||Hazard Ratio of progression free survival compared Arm C2 to Arm C1||1.32|0.64|0.64
91592732|NCT01984164|183076176|SUPERIORITY||Treatment effect size|-13.6|||||TWO_SIDED|95.0|-23.6|-3.7|||||effect size p-value = 0.008|All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).||-3.7|-23.6|
91592733|NCT00427349|183076186|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||one sample binomial test|The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test||The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).||||<0.001
91592734|NCT04456764|183076350|SUPERIORITY|||||||0.55||||||Test for group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.55
91790224|NCT00534313|183459764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||||TWO_SIDED|95.0|1.97|12.33|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as factor and baseline value as covariate was used for the analysis.||||12.33|1.97|
91592735|NCT04456764|183076351|SUPERIORITY|||||||0.12||||||group x time interaction|Mixed Models Analysis|random agency and a random participant effect||||||0.12
91592736|NCT04456764|183076352|SUPERIORITY|||||||0.0986|||||||Mixed Models Analysis|Adjusted for clustering.||||||0.0986
91592737|NCT04456764|183076353|SUPERIORITY|||||||0.51||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.51
91592738|NCT04456764|183076354|SUPERIORITY|||||||0.04||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.04
91592739|NCT04456764|183076355|SUPERIORITY|||||||0.02||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.02
91592740|NCT03227471|183076362|OTHER|||||||0.9943||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.9943
91592741|NCT03227471|183076362|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
91592742|NCT03227471|183076362|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||< 0.0001
91592743|NCT03227471|183076362|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
91592744|NCT03227471|183076363|OTHER|||||||0.8869||||||P value within treatment.|Mixed-effects model for repeated measure|||||||0.8869
91592745|NCT03227471|183076363|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
91592746|NCT03227471|183076364|OTHER|||||||0.6407||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.6407
91592747|NCT03227471|183076364|OTHER||||||<|0.0001||||||P value within treatment.|mixed-effects model for repeated measure|||||||<0.0001
91592748|NCT03227471|183076379|OTHER|||||||0.5802||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.5802
91790225|NCT00534313|183459764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.12|||||TWO_SIDED|95.0|3.83|14.41|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis||||14.41|3.83|
91790226|NCT00534313|183459764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.17|||||TWO_SIDED|95.0|1.01|11.32|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||11.32|1.01|
91592749|NCT03227471|183076379|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592750|NCT03227471|183076379|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592751|NCT03227471|183076379|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592752|NCT03227471|183076380|OTHER|||||||0.8712||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8712
91592753|NCT03227471|183076380|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
91592754|NCT03227471|183076381|OTHER|||||||0.8359||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8359
91592755|NCT03227471|183076381|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
91592756|NCT03227471|183076382|OTHER|||||||0.9453||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.9453
91592757|NCT03227471|183076382|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592758|NCT03227471|183076382|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592759|NCT03227471|183076382|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592760|NCT03227471|183076383|OTHER|||||||0.7849||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7849
91592761|NCT03227471|183076383|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
91592762|NCT03227471|183076384|OTHER|||||||0.7356||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7356
91592763|NCT03227471|183076384|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
91592764|NCT03227471|183076385|OTHER|||||||0.394||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.3940
91592765|NCT03227471|183076385|OTHER|||||||0.0003||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.0003
91592766|NCT03227471|183076385|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592767|NCT03227471|183076385|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
91592768|NCT03227471|183076386|OTHER|||||||0.4757||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.4757
91592769|NCT03227471|183076386|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
91592770|NCT03227471|183076387|OTHER|||||||0.007||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.0070
91592771|NCT03227471|183076387|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
91592772|NCT00736255|183076392|SUPERIORITY_OR_OTHER|||||||0.54|||||||Chi-squared|||"Null Hypothesis:LDX and NRT will not facilitate smoking cessation compared to NRT and placebo.~Alternate Hypothesis: LDX and NRT will facilitate smoking cessation compared to NRT and placebo.~This is a one tailed, proof of concept study so there is no formal power analysis, however if we see a signal for treatment effect, we would like to do further investigation by conducting a separate trial."||||0.54
91592773|NCT00980200|183076403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.001|TWO_SIDED|95.0|0.049|0.14|||ANCOVA|||||0.140|0.049|<0.001
91592774|NCT00980200|183076403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.095|0.185|||ANCOVA|||||0.185|0.095|<0.001
91592775|NCT00980200|183076403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.057|0.147|||ANCOVA|||||0.147|0.057|<0.001
91592776|NCT00980200|183076403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.08|0.17|||ANCOVA|||||0.170|0.080|<0.001
91592777|NCT00457015|183076407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The primary efficacy analysis compared the change from baseline in MSCS Score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.010
91592778|NCT00457015|183076408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.003
91592779|NCT00457015|183076409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||Kaplan-Meier analysis using the Log-Rank test was used to compare the time distribution between the 2 treatment groups.||||0.102
91592780|NCT03670953|183076412|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.226||0.0194|TWO_SIDED|95.0|0.09|0.97||"LSM, SE, CI and p-value from a MMRM with CFB in Good on time as outcome, baseline Good on time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||0.97|0.09|0.0194
91592781|NCT03670953|183076413|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.214||0.0252|TWO_SIDED|95.0|-0.9|-0.06||"LSM, SE, CI and p-value from a MMRM with CFB in Off time as outcome, baseline Off time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||-0.06|-0.90|0.0252
91592782|NCT03670953|183076414|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Percent difference|10.9||||0.0015|TWO_SIDED|95.0|3.5|18.3||"P-value from the Cochran-Mantel-Haenszel test stratified by pooled center comparing the percentage of Much or Very Much Improved participants between the treatment groups."|Cochran-Mantel-Haenszel|||||18.3|3.5|0.0015
91592783|NCT03670953|183076415|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9587|TWO_SIDED|95.0|-1.8|1.7||LSM, SE, CI and p-value from a MMRM with CFB in MDS-UPDRS Part III Score as outcome, baseline MDS-UPDRS Part III Score as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||1.7|-1.8|0.9587
91592784|NCT03670953|183076416|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.11||0.9668|TWO_SIDED|95.0|-2.2|2.1||LSM, SE, CI \& p-value from MMRM with CFB in MDS-UPDRS Part II \& III Scores as outcome, baseline MDS-UPDRS Part II and III Scores as a covariate, treatment and visit as fixed effects, pooled center as random effect \& a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||2.1|-2.2|0.9668
91592785|NCT00937937|183076418|SUPERIORITY_OR_OTHER_LEGACY||1-year overall survival estimate|0.38|||||TWO_SIDED|95.0|0.27|0.49||||||one-year overall survival estimate.||0.49|0.27|
91592786|NCT00937937|183076419|SUPERIORITY_OR_OTHER_LEGACY||6-month PFS estimate|0.07|||||TWO_SIDED|95.0|0.03|0.15||||||6-month PFS estimate.||0.15|0.03|
91592787|NCT00054704|183076424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.828|STANDARD_ERROR_OF_MEAN|3.182||0.086|TWO_SIDED|95.0|-12.59|0.934||A linear mixed model included drug, visit and their interaction as fixed factors. Subject was a random factor. The test here is for the main effect of drug.|Mixed Models Analysis|Baseline score was a covariate. Restricted maximum likelihood estimates were used with a compound symmetry covariance structure.||The primary intent of this study was to compare the efficacy of riluzole to placebo in the treatment of overall depressive symptomatology of bipolar disorder subjects who were acutely depressed. Data from 8 riluzole and 11 placebo participants were analyzed due to missing data for one riluzole patient.||0.934|-12.590|.086
91592788|NCT05368961|183076482|OTHER|Null hypothesis; there is no difference in anxiety scores between usual care and distraction||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91592789|NCT05714982|183076491|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592790|NCT05714982|183076491|SUPERIORITY|||||||0.78|||||||General linear model|||||||.78
91592791|NCT05714982|183076492|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592792|NCT05714982|183076492|SUPERIORITY|||||||0.66|||||||General linear model|||||||.66
91592793|NCT05714982|183076493|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592794|NCT05714982|183076493|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592795|NCT05714982|183076494|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
91592796|NCT05714982|183076494|SUPERIORITY|||||||0.95|||||||General linear model|||||||.95
91592797|NCT05714982|183076495|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592798|NCT05714982|183076495|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592799|NCT05714982|183076496|SUPERIORITY||||||<|0.0001|||||||General linear model|||||||<.0001
91592800|NCT05714982|183076496|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592801|NCT05714982|183076497|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592802|NCT05714982|183076497|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
91592803|NCT05714982|183076498|SUPERIORITY|||||||0.03|||||||General linear model|||||||.03
91592804|NCT05714982|183076498|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
91592805|NCT05714982|183076499|SUPERIORITY|||||||0.61|||||||General linear model|||||||.61
91592806|NCT05714982|183076499|SUPERIORITY|||||||0.68|||||||General linear model|||||||.68
91592807|NCT05714982|183076500|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
91592808|NCT05714982|183076500|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
91592809|NCT05714982|183076501|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
91592810|NCT05714982|183076501|SUPERIORITY|||||||0.9|||||||General linear model|||||||.9
91592811|NCT05714982|183076502|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.73|1.2||||||||1.2|.73|
91592812|NCT05714982|183076502|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.69|1.2||||||||1.2|.69|
91592813|NCT05714982|183076503|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.3|0.9||||||||.9|.3|
91592814|NCT05714982|183076503|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|.6|
91592815|NCT05714982|183076504|SUPERIORITY|||||||0.02|||||||General linear model|||||||.02
91592816|NCT05714982|183076504|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
91592817|NCT05714982|183076505|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
91592818|NCT05714982|183076505|SUPERIORITY|||||||0.004|||||||General linear model|||||||.004
91592819|NCT05714982|183076506|SUPERIORITY|||||||0.3|||||||General linear model|||||||0.3
91592820|NCT05714982|183076506|SUPERIORITY|||||||0.5|||||||General linear model|||||||0.5
91592821|NCT05714982|183076507|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.99|2.1||||||||2.1|.99|
91592822|NCT05714982|183076507|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
91592823|NCT01911442|183076508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.15||0.5463|TWO_SIDED|95.0|-5.6|3.0|||Mixed Models Analysis|||LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||3.0|-5.6|0.5463
91592824|NCT01911442|183076508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.09||0.3592|TWO_SIDED|95.0|-6.1|2.2|||Mixed Models Analysis|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.||2.2|-6.1|0.3592
91592825|NCT01911442|183076509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1755|TWO_SIDED||||||Mixed Models Analysis||This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.|||||0.1755
91592826|NCT01911442|183076509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2402|TWO_SIDED||||||Mixed Models Analysis|||||||0.2402
91592827|NCT02101515|183076549|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.22|0.93||||||||0.93|0.22|
91592828|NCT02101515|183076551|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.41|||||TWO_SIDED|95.0|0.67|8.4||||||||8.40|0.67|
91592829|NCT02101515|183076552|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
91592830|NCT02101515|183076553|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.71|||||TWO_SIDED|95.0|1.3|5.62||||||||5.62|1.30|
91592831|NCT02101515|183076554|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.06|13.92||||||||13.92|0.06|
91592832|NCT02101515|183076556|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.41|||||TWO_SIDED|95.0|0.68|42.9||||||||42.90|0.68|
91592833|NCT02101515|183076558|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.46|1.54||||||||1.54|0.46|
91592834|NCT02101515|183076559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.39|1.49||||||||1.49|0.39|
91592835|NCT02101515|183076561|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
91592836|NCT02101515|183076565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3|||||TWO_SIDED|95.0|0.03|2.77||||||||2.77|0.03|
91592837|NCT02790138|183076566|SUPERIORITY||Percentage Difference|21.6||||0.013|TWO_SIDED|95.0|4.9|37.5||The significance level was 0.05.|Fisher's Exact Test|||The Placebo IV and Vedolizumab IV 300 mg groups were analyzed using Fisher's Exact Test at Week 14.||37.5|4.9|0.013
91592838|NCT02790138|183076567|SUPERIORITY||Percentage Difference|17.6|||=|0.043|TWO_SIDED|95.0|0.3|35.1||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||||35.1|0.3|=0.043
91592839|NCT02790138|183076568|SUPERIORITY||Percentage Difference|25.5|||=|0.004|TWO_SIDED|95.0|8.0|41.4||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Fisher's Exact Test|||Week 14||41.4|8.0|=0.004
91592840|NCT02790138|183076568|SUPERIORITY||Percentage Difference|19.6|||=|0.027|TWO_SIDED|95.0|1.9|37.0||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34.||37.0|1.9|=0.027
91592841|NCT02790138|183076569|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|1.7|9.4|||||Hazard ratio for achieving PDAI remission.|||9.4|1.7|
91592842|NCT02790138|183076570|SUPERIORITY||Percentage Difference|29.4|||=|0.003|TWO_SIDED|95.0|8.0|47.6||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 14||47.6|8.0|=0.003
91592843|NCT02790138|183076570|SUPERIORITY||Percentage Difference|21.6|||=|0.026|TWO_SIDED|95.0|1.9|39.8||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34||39.8|1.9|=0.026
91592844|NCT02790138|183076571|SUPERIORITY||Odds Estimator|2.02|||=|0.002|TWO_SIDED|95.0|1.11|2.93||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.93|1.11|=0.002
91592845|NCT02790138|183076571|SUPERIORITY||Odds Estimator|1.71|||=|0.02|TWO_SIDED|95.0|0.92|2.49||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.49|0.92|=0.020
91592846|NCT02790138|183076572|SUPERIORITY||Odds Estimator|1.34|||=|0.191|TWO_SIDED|95.0|0.74|1.94||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.94|0.74|=0.191
91592847|NCT02790138|183076572|SUPERIORITY||Odds Estimator|1.07|||=|0.766|TWO_SIDED|95.0|0.6|1.54||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.54|0.60|=0.766
91592848|NCT02790138|183076573|SUPERIORITY||Odds Estimator|1.57|||=|0.055|TWO_SIDED|95.0|0.83|2.31||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.31|0.83|=0.055
91592849|NCT02790138|183076573|SUPERIORITY||Odds Estimator|1.48|||=|0.095|TWO_SIDED|95.0|0.79|2.16||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.16|0.79|=0.095
91592850|NCT02790138|183076574|SUPERIORITY||Odds Estimator|1.14|||=|0.575|TWO_SIDED|95.0|0.61|1.67||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.67|0.61|=0.575
91592851|NCT02790138|183076574|SUPERIORITY||Odds Estimator|1.21|||=|0.403|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.78|0.65|=0.403
91592852|NCT02790138|183076574|SUPERIORITY||Odds Estimator|1.6|||=|0.047|TWO_SIDED|95.0|0.85|2.34||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.34|0.85|=0.047
91592853|NCT02790138|183076575|SUPERIORITY||Odds Estimator|1.44|||=|0.119|TWO_SIDED|95.0|0.77|2.12||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.12|0.77|=0.119
91782603|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.93|
91782604|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.96|1.01||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.01|0.96|
91790227|NCT00534313|183459765|SUPERIORITY_OR_OTHER||Difference|16.0|||||TWO_SIDED|95.0|-2.5|34.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.5|-2.5|
91790228|NCT00534313|183459765|SUPERIORITY_OR_OTHER||Difference|26.1||||||95.0|6.8|45.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||45.5|6.8|
91790229|NCT00534313|183459765|SUPERIORITY_OR_OTHER||Difference|16.6||||||95.0|-1.8|34.9|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.9|-1.8|
91592854|NCT02790138|183076575|SUPERIORITY||Odds Estimator|1.15|||=|0.542|TWO_SIDED|95.0|0.62|1.69||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.69|0.62|=0.542
91592855|NCT02790138|183076575|SUPERIORITY||Odds Estimator|1.22|||=|0.404|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.78|0.65|=0.404
91592856|NCT01226459|183076588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.0|13.1|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.||13.1|5.0|<0.0001
91592857|NCT01226459|183076589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|7.0|14.7|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is of the change from baseline to week 12 data.||14.7|7.0|<0.0001
91592858|NCT01226459|183076590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04|||ANCOVA|||||1.04|0.35|<0.0001
91592859|NCT03770091|183076591|SUPERIORITY|ANOVA performed||||||0.6|||||||ANOVA|||||||0.6
91592860|NCT03770091|183076592|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
91592861|NCT03770091|183076593|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
91592862|NCT03770091|183076594|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
91592863|NCT03770091|183076595|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
91592864|NCT01092143|183076603|SUPERIORITY||Adjusted mean treatment differences|3.083|STANDARD_DEVIATION|1.65||0.0311|TWO_SIDED|95.0|-0.157|6.323||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.323|-0.157|0.0311
91592865|NCT01092143|183076603|SUPERIORITY||Adjusted mean treatment differences|3.589|STANDARD_DEVIATION|1.6||0.0126|TWO_SIDED|95.0|0.447|6.732||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, trea||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.732|0.447|0.0126
91592866|NCT01092143|183076603|SUPERIORITY||Adjusted mean treatment differences|3.977|STANDARD_DEVIATION|1.64||0.0078|TWO_SIDED|95.0|0.756|7.197||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with placebo, after 6 weeks.||7.197|0.756|0.0078
91592867|NCT01092143|183076603|OTHER||Adjusted mean treatment differences|8.619|STANDARD_DEVIATION|1.684|<|0.0001|TWO_SIDED|95.0|5.312|11.927||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with fluticasone propionate 110 mcg 2 puffs b.i.d. compared with those treated with placebo, after 6 weeks.||11.927|5.312|<.0001
91592868|NCT01092143|183076603|SUPERIORITY||Adjusted mean treatment differences|-5.536|STANDARD_DEVIATION|1.653||0.9996|TWO_SIDED|95.0|-8.783|-2.29||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-2.290|-8.783|0.9996
91592869|NCT01092143|183076603|SUPERIORITY||Adjusted mean treatment differences|-5.03|STANDARD_DEVIATION|1.606||0.9991|TWO_SIDED|95.0|-8.185|-1.875||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with fluticasone propionate 220mcg b.i.d., after 6 weeks.||-1.875|-8.185|0.9991
91592870|NCT01092143|183076603|SUPERIORITY||Adjusted mean treatment differences|-4.643|STANDARD_DEVIATION|1.647||0.9975|TWO_SIDED|95.0|-7.877|-1.408||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-1.408|-7.877|0.9975
91592871|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|0.073|STANDARD_DEVIATION|0.113||0.7413|TWO_SIDED|95.0|-0.149|0.295||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.295|-0.149|0.7413
91592872|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|-0.08|STANDARD_DEVIATION|0.11||0.2335|TWO_SIDED|95.0|-0.296|0.136||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.136|-0.296|0.2335
91592873|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|-0.061|STANDARD_DEVIATION|0.113||0.2933|TWO_SIDED|95.0|-0.282|0.16||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.160|-0.282|0.2933
91592874|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|-0.333|STANDARD_DEVIATION|0.116||0.0021|TWO_SIDED|95.0|-0.561|-0.105||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.105|-0.561|0.0021
91592875|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|0.406|STANDARD_DEVIATION|0.114||0.9998|TWO_SIDED|95.0|0.183|0.63||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.630|0.183|0.9998
91592876|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|0.253|STANDARD_DEVIATION|0.11||0.989|TWO_SIDED|95.0|0.037|0.47||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.470|0.037|0.9890
91592877|NCT01092143|183076604|SUPERIORITY||Adjusted mean treatment differences|0.272|STANDARD_DEVIATION|0.113||0.9918|TWO_SIDED|95.0|0.05|0.494||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.494|0.050|0.9918
91592878|NCT00698997|183076644|OTHER|Non- equivalence.|slope difference|1.01||||0.03|TWO_SIDED||||||Mixed Models Analysis|||We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen's recommendations as f2.||||.03
91592879|NCT05082376|183076668|OTHER||Adjusted Mean Difference|7.7|||<|0.0001|TWO_SIDED|95.0|6.6|8.8|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||8.8|6.6|<0.0001
91592880|NCT05082376|183076668|OTHER||Adjusted Mean Difference|6.9|||<|0.0001|TWO_SIDED|95.0|5.8|7.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment.||7.9|5.8|<0.0001
91592881|NCT05082376|183076668|OTHER||Adjusted Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|4.0|6.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment.||6.2|4.0|<0.0001
91592882|NCT05082376|183076668|OTHER||Adjusted Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.6|5.8|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment.||5.8|3.6|<0.0001
91592883|NCT02568475|183076670|EQUIVALENCE|Continuous scale: score compares results before and after intervention without a cut parameter.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.74||0.046|TWO_SIDED|95.0|0.059|7.12|||t-test, 2 sided|||||7.12|0.059|0.046
91790230|NCT00402233|183459766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.0001||95.0|-6.53|-2.26|||ANCOVA|||||-2.26|-6.53|<0.0001
91790231|NCT00402233|183459766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|||<|0.0001||95.0|-6.54|-2.28|||ANCOVA|||||-2.28|-6.54|<0.0001
91790232|NCT00402233|183459766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72|||<|0.0001||95.0|-6.91|-2.52|||ANCOVA|||||-2.52|-6.91|<0.0001
91790233|NCT00402233|183459767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||||95.0|0.431|1.849|||Regression, Logistic|||||1.849|0.431|
91790234|NCT00402233|183459767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.885||||||95.0|0.424|1.845|||Regression, Logistic|||||1.845|0.424|
91790235|NCT00402233|183459767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||||95.0|0.317|1.492|||Regression, Logistic|||||1.492|0.317|
91790236|NCT00402233|183459768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.014||95.0|0.23|2.04|||ANCOVA|||||2.04|0.23|0.014
91790237|NCT00402233|183459768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03||95.0|0.094|1.9|||ANCOVA|||||1.9|0.094|0.03
91790238|NCT00402233|183459768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49||||0.0019||95.0|0.56|2.43|||ANCOVA|||||2.43|0.56|0.0019
91790239|NCT00402233|183459769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.39||95.0|-1.82|0.71|||ANCOVA|||||0.71|-1.82|0.39
91790240|NCT00402233|183459769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.37||95.0|-1.84|0.69|||ANCOVA|||||0.69|-1.84|0.37
91790241|NCT00402233|183459769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.48||95.0|-1.78|0.84|||ANCOVA|||||0.84|-1.78|0.48
91790242|NCT00827931|183459801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-99.9|STANDARD_ERROR_OF_MEAN|131.99||0.46|TWO_SIDED|95.0|-371.4|171.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||171.5|-371.4|0.460
91790243|NCT00827931|183459802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.6|STANDARD_ERROR_OF_MEAN|147.61||0.579|TWO_SIDED|95.0|-386.5|219.3|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||219.3|-386.5|0.579
91592884|NCT02568475|183076671|OTHER|This is a continuous scale with no clinical cut score/value. We tested mean differences between the two groups.|Mean Difference (Final Values)|6.78||||0.001|TWO_SIDED|95.0|2.9|10.6|||t-test, 2 sided|||||10.6|2.9|0.001
91592885|NCT02504554|183076677|OTHER||||||<|0.001||||||"no adjustment for multiple hypothesis testing since this was an exploratory study.~the p-value listed is the actual result from analysis of the study data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank analysis of symptoms at 10 weeks (end of treatment) vs. baseline||||<0.001
91592886|NCT02504554|183076678|OTHER|paired 2-sided t-test comparing baseline and 10 weeks (end of treatment)|||||<|0.001||||||no adjustment for multiple comparisons|t-test, 2 sided|paired t-test, 2 sided||||||<0.001
91592887|NCT02504554|183076680|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~The p-value listed is the result for the actual analysis of the data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing the baseline score vs. the score at 10 weeks (end of treatment).||||<0.001
91592888|NCT02504554|183076681|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the study results."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing scores at baseline vs. 10 weeks (end of treatment)||||<0.001
91782605|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.00|0.94|
91782606|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
91782607|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.06|0.96|
91782608|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.07|0.93|
91790244|NCT00827931|183459803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.5|STANDARD_ERROR_OF_MEAN|239.19||0.452|TWO_SIDED|95.0|-672.6|305.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||305.5|-672.6|0.452
91790245|NCT00827931|183459804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-417.7|STANDARD_ERROR_OF_MEAN|152.51||0.01|TWO_SIDED|95.0|-729.4|-106.1|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||-106.1|-729.4|0.010
91790246|NCT00827931|183459805|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used at 5% level of significance.||||0.701
91790247|NCT04157673|183459845|SUPERIORITY|||||||0.0002||||||This is the overall treatment effect from the mixed model. p-value threshold set at p = 0.05.|Mixed Models Analysis|||Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||0.0002
91592889|NCT02504554|183076683|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the analysis of the study data"|t-test, 2 sided|||2-sided t-test comparing the group at baseline vs. 18 weeks (8 weeks after end of treatment)||||<0.001
91592890|NCT02504554|183076684|OTHER|||||||0.002||||||no adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare scores at baseline vs. at 10 weeks (end of treatment)||||0.002
91592891|NCT00290186|183076685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.539||95.0|-1.5|3.3|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.3|-1.5|0.539
91592892|NCT00290186|183076686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.921|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.8|-1.6|0.921
91790248|NCT04157673|183459846|OTHER|Effect size of mean differences|Mean Difference (Final Values)|2.75|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Cohen's d effect size = 0.73|Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||
91790249|NCT04157673|183459847|OTHER|Effect size of mean pre-post differences|Mean Difference (Final Values)|0.355|STANDARD_DEVIATION|0.295|||TWO_SIDED||||||||cohen's d effect size for mean differences pre to post-treatment = 1.20|||||
91790250|NCT02282293|183459868|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61||Calculated p-value|Chi-squared|||||7.61|0.50|0.50
91790251|NCT02282293|183459870|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61|||Chi-squared|||||7.61|0.50|0.50
91790252|NCT02282293|183459872|OTHER||Risk Ratio (RR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.48||Calculated p-value|GEE|||||1.48|0.13|0.19
91790253|NCT02282293|183459873|OTHER||Risk Ratio (RR)|1.33||||0.35|TWO_SIDED|95.0|0.72|2.45|||Chi-squared|||||2.45|0.72|0.35
91790254|NCT01894568|183459890|NON_INFERIORITY_OR_EQUIVALENCE|0.4% is the margin of Non-inferiority|LS Mean Difference|-0.24||||0.005|TWO_SIDED|95.0|-0.41|-0.07|||Mixed Models Analysis|||||-0.07|-0.41|0.005
91592893|NCT00290186|183076687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.945|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.945
91592894|NCT00290186|183076688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.342|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-5.1|0.342
91592895|NCT00290186|183076689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.149|TWO_SIDED|95.0|-1.6|8.6|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||8.6|-1.6|0.149
91592896|NCT00290186|183076690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.685|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.685
91592897|NCT00290186|183076691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.584|TWO_SIDED|95.0|-2.4|3.0|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.0|-2.4|0.584
91592898|NCT00290186|183076692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.498|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.7|-1.5|0.498
91592899|NCT00290186|183076693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.945|TWO_SIDED|95.0|-2.3|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-2.3|0.945
91782609|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.05|||||TWO_SIDED|90.0|0.99|1.11||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.11|0.99|
91592900|NCT00290186|183076694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.932|TWO_SIDED|95.0|-2.1|2.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.4|-2.1|0.932
91782610|NCT02637037|183444410|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.03|||||TWO_SIDED|90.0|0.96|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.96|
91782611|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.94|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.94|
91790255|NCT04545944|183459909|OTHER||Geometric Least Squares Mean Ratio|192.4|||||TWO_SIDED|90.0|152.8|242.4||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||242.4|152.8|
91790256|NCT04545944|183459910|OTHER||Geometric Least Squares Mean Ratio|188.9|||||TWO_SIDED|90.0|150.6|236.9||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||236.9|150.6|
91592901|NCT00290186|183076695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.051|TWO_SIDED|95.0|-0.2|4.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||4.7|-0.2|0.051
91592902|NCT00290186|183076696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.648|TWO_SIDED|95.0|-4.0|2.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.8|-4.0|0.648
91592903|NCT00290186|183076697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.473|TWO_SIDED|95.0|-4.7|1.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.4|-4.7|0.473
91592904|NCT00290186|183076698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0||||0.157|TWO_SIDED|95.0|-22.0|114.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||114|-22|0.157
91592905|NCT00290186|183076699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-15.0|13.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||13|-15|0.876
91592906|NCT00290186|183076700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-79.0||||0.167|TWO_SIDED|95.0|-198.0|41.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||41|-198|0.167
91592907|NCT00290186|183076701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.0||||0.468|TWO_SIDED|95.0|-153.0|77.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||77|-153|0.468
91592908|NCT00282295|183076720|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|2.18|||||TWO_SIDED|95.0|0.79|4.17||||||The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||4.17|0.79|
91592909|NCT00282295|183076720|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|0.02|||||TWO_SIDED|95.0|-1.4|1.48||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||1.48|-1.4|
91592910|NCT00282295|183076721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of 0.67|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.||1.03|0.84|
91592911|NCT00282295|183076721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.69|0.84||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.||0.84|0.69|
91592912|NCT00282295|183076721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.63|||||TWO_SIDED|95.0|0.54|0.72||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.||0.72|0.54|
91592913|NCT00282295|183076722|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-4.38|||||TWO_SIDED|95.0|-9.91|1.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.||1.15|-9.91|
91592914|NCT00282295|183076722|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-3.39|||||TWO_SIDED|95.0|-7.03|0.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.||0.15|-7.03|
91592915|NCT00282295|183076722|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-1.96|||||TWO_SIDED|95.0|-5.25|-1.25||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.||-1.25|-5.25|
91592916|NCT00282295|183076723|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|-0.21|||||TWO_SIDED|95.0|-4.85|4.43||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.||4.43|-4.85|
91592917|NCT00282295|183076723|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.69|||||TWO_SIDED|95.0|-1.69|5.16||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.||5.16|-1.69|
91592918|NCT00282295|183076723|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.82||||||95.0|-2.58|6.25||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.||6.25|-2.58|
91592919|NCT00282295|183076723|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|3.56|||||TWO_SIDED|95.0|0.96|6.45||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination||6.45|0.96|
91592920|NCT01401842|183076750|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on lumbar extension muscular strength (Nm) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.001
91592921|NCT01401842|183076751|SUPERIORITY_OR_OTHER|||||||0.871|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.871
91592922|NCT01401842|183076752|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.021
91592923|NCT01251653|183076789|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|81.27|STANDARD_DEVIATION|63.3||0.4815|TWO_SIDED|90.0|44.863|147.205|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.205|44.863|0.4815
91592924|NCT01251653|183076789|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|95.36|STANDARD_DEVIATION|15.4||0.0149|TWO_SIDED|90.0|84.139|108.077|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||108.077|84.139|0.0149
91592925|NCT01251653|183076789|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|88.12|STANDARD_DEVIATION|9.2||0.0208|TWO_SIDED|90.0|81.778|94.964|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.964|81.778|0.0208
91592926|NCT01251653|183076790|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|141.36|STANDARD_DEVIATION|14.7||0.8715|TWO_SIDED|90.0|115.848|172.495|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||172.495|115.848|0.8715
91592927|NCT01251653|183076790|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|77.42|STANDARD_DEVIATION|16.8||0.6805|TWO_SIDED|90.0|68.516|87.473|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||87.473|68.516|0.6805
91592928|NCT01251653|183076790|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|83.95|STANDARD_DEVIATION|14.3||0.2327|TWO_SIDED|90.0|74.794|94.217|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.217|74.794|0.2327
91592929|NCT01251653|183076791|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|136.11|STANDARD_DEVIATION|26.3||0.7759|TWO_SIDED|90.0|112.09|165.29|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||165.29|112.09|0.7759
91592930|NCT01251653|183076792|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|118.41|STANDARD_DEVIATION|31.6||0.3359|TWO_SIDED|90.0|94.81|147.88|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.88|94.81|0.3359
91592931|NCT01251653|183076795|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|93.69|STANDARD_DEVIATION|19.5||0.0349|TWO_SIDED|90.0|81.352|107.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||107.890|81.352|0.0349
91790257|NCT04545944|183459911|OTHER||Geometric Least Squares Mean Ratio|193.4|||||TWO_SIDED|90.0|160.5|233.1||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||233.1|160.5|
91790258|NCT01514370|183459917|OTHER|||||||0.271|||||||Chi-squared|||||||0.271
91790259|NCT03207035|183460014|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91790260|NCT03207035|183460015|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91790261|NCT03207035|183460016|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
91790262|NCT03207035|183460017|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
91790263|NCT03207035|183460018|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91790264|NCT03207035|183460019|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91790265|NCT03207035|183460020|OTHER|||||||0.53|||||||Chi-squared|||||||0.53
91790266|NCT03207035|183460021|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
91790267|NCT03645434|183460023|SUPERIORITY||Mean Difference (Final Values)|0.202|||<|0.0001|TWO_SIDED|95.0|0.151|0.253|||Mixed Models Analysis|||||0.253|0.151|<0.0001
91790268|NCT03645434|183460028|SUPERIORITY||Mean Difference (Final Values)|0.098|||<|0.0001|TWO_SIDED|95.0|0.051|0.146|||Mixed Models Analysis|||Day 2||0.146|0.051|<0.0001
91790269|NCT03645434|183460028|SUPERIORITY||Mean Difference (Final Values)|0.195|||<|0.0001|TWO_SIDED|95.0|0.148|0.242|||Mixed Models Analysis|||Day 8||0.242|0.148|<0.0001
91790270|NCT03645434|183460029|SUPERIORITY||Mean Difference (Final Values)|0.306|||<|0.0001|TWO_SIDED|95.0|0.266|0.346|||Mixed Models Analysis|||Day 1||0.346|0.266|<0.0001
91592932|NCT01251653|183076795|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|98.11|STANDARD_DEVIATION|30.4||0.0405|TWO_SIDED|90.0|81.053|118.76|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||118.760|81.053|0.0405
91592933|NCT01251653|183076796|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|90.78|STANDARD_DEVIATION|22.8||0.0728|TWO_SIDED|90.0|78.566|104.901|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||104.901|78.566|0.0728
91592934|NCT01251653|183076796|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|85.74|STANDARD_DEVIATION|48.9||0.3294|TWO_SIDED|90.0|65.561|112.138|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||112.138|65.561|0.3294
91592935|NCT00847145|183076800|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.||2|-5|
91592936|NCT00847145|183076800|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.|Percentage group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.||5|-5|
91592937|NCT00847145|183076800|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.||1|-4|
91592938|NCT00847145|183076800|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.||3|-6|
91592939|NCT00847145|183076800|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-11.0|7.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.||7|-11|
91592940|NCT01439282|183076839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108||||||1-side P value was obtained|1-sample binomial test|||||||0.1080
91592941|NCT01469182|183076856|SUPERIORITY_OR_OTHER||Percent Difference|9.95||||0.005|TWO_SIDED|95.0|3.1|16.7|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||16.7|3.1|0.005
91592942|NCT01469182|183076857|SUPERIORITY_OR_OTHER||Percent Difference|5.58|||<|0.001|TWO_SIDED|95.0|2.9|8.2|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||8.2|2.9|<0.001
91592943|NCT01469182|183076858|SUPERIORITY_OR_OTHER||Percent Difference|7.88|||<|0.001|TWO_SIDED|95.0|5.5|10.5|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||10.5|5.5|<0.001
91592944|NCT01469182|183076859|SUPERIORITY_OR_OTHER||Percent Difference|10.17|||<|0.001|TWO_SIDED|95.0|6.6|13.6|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||13.6|6.6|<0.001
91592945|NCT01469182|183076860|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||<|0.001|TWO_SIDED|95.0|3.3|7.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||7.4|3.3|<0.001
91592946|NCT01469182|183076861|SUPERIORITY_OR_OTHER||Percent Difference|0.17||||0.861|TWO_SIDED|95.0|-2.1|1.9|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||1.9|-2.1|0.861
91592947|NCT01469182|183076862|SUPERIORITY_OR_OTHER||Percent Difference|1.15||||0.344||95.0|-1.5|3.3|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.3|-1.5|0.344
91592948|NCT01469182|183076863|SUPERIORITY_OR_OTHER||Percent Difference|0.99||||0.382|TWO_SIDED|95.0|-1.5|3.0|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.0|-1.5|0.382
91592949|NCT01469182|183076864|SUPERIORITY_OR_OTHER||Percent Difference|2.46||||0.029|TWO_SIDED|95.0|0.3|4.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||4.4|0.3|0.029
91592950|NCT01785160|183076884|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability (No formal testing was performed)|Adjusted Geometric Mean ratio|272.06|STANDARD_DEVIATION|67.9||0.9999||95.0|199.69|370.66||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||370.66|199.69|0.9999
91592951|NCT01785160|183076885|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability(No formal testing was performed)|Adjusted Geometric Mean ratio|245.72|STANDARD_DEVIATION|87.1||0.9973||95.0|168.46|358.404||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||358.404|168.460|0.9973
91592952|NCT00549939|183076906|SUPERIORITY_OR_OTHER|||||||1||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1.00
91592953|NCT00549939|183076906|SUPERIORITY_OR_OTHER|||||||0.91||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.91
91592954|NCT00549939|183076908|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-6.2|STANDARD_ERROR_OF_MEAN|3.8||0.104|TWO_SIDED|95.0|-13.72|1.29||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||1.29|-13.72|0.1040
91592955|NCT00549939|183076908|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-7.1|STANDARD_ERROR_OF_MEAN|3.77||0.104|TWO_SIDED|95.0|-14.51|0.39||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.39|-14.51|0.1040
91592956|NCT00549939|183076909|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-11.4|STANDARD_ERROR_OF_MEAN|7.54||0.1338|TWO_SIDED|95.0|-26.27|3.53||P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||3.53|-26.27|0.1338
91790271|NCT03645434|183460029|SUPERIORITY||Mean Difference (Final Values)|0.374|||<|0.0001|TWO_SIDED|95.0|0.324|0.425|||Mixed Models Analysis|||Day 8||0.425|0.324|<0.0001
91790272|NCT03645434|183460029|SUPERIORITY||Mean Difference (Final Values)|0.388|||<|0.0001|TWO_SIDED|95.0|0.329|0.447|||Mixed Models Analysis|||Day 14||0.447|0.329|<0.0001
91790273|NCT03645434|183460030|SUPERIORITY||Mean Difference (Final Values)|-0.551||||0.001|TWO_SIDED|95.0|-0.876|-0.226|||Mixed Models Analysis|||Day 1 to Day 8||-0.226|-0.876|0.0010
91790274|NCT03645434|183460030|SUPERIORITY||Mean Difference (Final Values)|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.248|-0.486|||Mixed Models Analysis|||Day 9 to Day 14||-0.486|-1.248|<0.0001
91790275|NCT03645434|183460030|SUPERIORITY||Mean Difference (Final Values)|-0.722|||<|0.0001|TWO_SIDED|95.0|-1.047|-0.397|||Mixed Models Analysis|||Day 1 to Day 14||-0.397|-1.047|<0.0001
91790276|NCT03645434|183460031|SUPERIORITY||Mean Difference (Final Values)|-1.571||||0.0022|TWO_SIDED|95.0|-2.563|-0.579|||Mixed Models Analysis|||Day 1 to Day 8||-0.579|-2.563|0.0022
91790277|NCT03645434|183460031|SUPERIORITY||Mean Difference (Final Values)|-2.386|||<|0.0001|TWO_SIDED|95.0|-3.541|-1.23|||Mixed Models Analysis|||Day 9 to Day 14||-1.230|-3.541|<0.0001
91790278|NCT03645434|183460031|SUPERIORITY||Mean Difference (Final Values)|-1.912||||0.0003|TWO_SIDED|95.0|-2.923|-0.901|||Mixed Models Analysis|||Day 1 to Day 14||-0.901|-2.923|0.0003
91790279|NCT03645434|183460042|SUPERIORITY||Mean Difference (Final Values)|-1.268|||<|0.0001|TWO_SIDED|95.0|-1.741|-0.794|||Mixed Models Analysis|||Day 1 to Day 8||-0.794|-1.741|<0.0001
91790280|NCT03645434|183460042|SUPERIORITY||Mean Difference (Final Values)|-1.302|||<|0.0001|TWO_SIDED|95.0|-1.804|-0.8|||Mixed Models Analysis|||Day 9 to Day 14||-0.800|-1.804|<0.0001
91790281|NCT02880956|183460050|SUPERIORITY||Least Squares (LS) Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.178||0.74|TWO_SIDED|95.0|-0.291|0.409||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.291|0.740
91790282|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790283|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.176||0.367|TWO_SIDED|95.0|-0.504|0.187||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.187|-0.504|0.367
91790284|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790285|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.843|TWO_SIDED|95.0|-0.318|0.389||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.389|-0.318|0.843
91790286|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91592957|NCT00549939|183076909|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-14.3|STANDARD_ERROR_OF_MEAN|7.48||0.1152|TWO_SIDED|95.0|-29.1|0.47||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.47|-29.10|0.1152
91592958|NCT00549939|183076911|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor compliance as covariate."||||0.7889
91592959|NCT00549939|183076911|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||||0.7889
91592960|NCT01360554|183076933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.195|TWO_SIDED|95.0|0.797|1.093||One-sided P-value.|1-sided stratified log-rank test|Stratified by epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG).|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS, baseline ECOG as stratification factors.|||1.093|0.797|0.195
91592961|NCT01360554|183076934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.037||||0.643|TWO_SIDED|95.0|0.848|1.268||One-sided P-value|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.268|0.848|0.643
91592962|NCT01360554|183076935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.069|TWO_SIDED|95.0|0.78|1.035||Stratified by EGFR status, KRAS status, and baseline ECOG.|1-sided stratified log-rank test|One-sided P-value|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.035|0.780|0.069
91592963|NCT01360554|183076936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.728|TWO_SIDED|95.0|0.881|1.267||One-sided P-value.|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.267|0.881|0.728
91592964|NCT01360554|183076937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.638|TWO_SIDED|95.0|0.887|1.188||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status, KRAS status, and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.188|0.887|0.638
91592965|NCT01360554|183076938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.775|TWO_SIDED|95.0|0.886|1.312||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.312|0.886|0.775
91592966|NCT01360554|183076946|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.9357||||||95.0|-4.278|0.407|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Global QoL. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||0.407|-4.278|
91592967|NCT01360554|183076946|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.8067||||||95.0|-1.312|2.926|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 cognitive functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.926|-1.312|
91592968|NCT01360554|183076946|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|0.73||||||95.0|-1.575|3.035|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 emotional functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.035|-1.575|
91592969|NCT01360554|183076946|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.5289||||||95.0|-0.756|3.814|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 physical functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.814|-0.756|
91592970|NCT01360554|183076946|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2219||||||95.0|-1.975|4.419|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 role functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.419|-1.975|
91521565|NCT00508261|182917710|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.73|||||TWO_SIDED|95.0|0.73|6.24||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.||6.24|0.73|
91790287|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.222||0.703|TWO_SIDED|95.0|-0.351|0.52||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.520|-0.351|0.703
91790288|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790289|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.218||0.947|TWO_SIDED|95.0|-0.442|0.413||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.413|-0.442|0.947
91790290|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790291|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.222||0.732|TWO_SIDED|95.0|-0.514|0.361||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.361|-0.514|0.732
91790292|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790293|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.939|TWO_SIDED|95.0|-0.623|0.576||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.576|-0.623|0.939
91790294|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790295|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.299||0.872|TWO_SIDED|95.0|-0.637|0.54||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.540|-0.637|0.872
91790296|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790297|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.305||0.773|TWO_SIDED|95.0|-0.688|0.512||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.512|-0.688|0.773
91790298|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790299|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.387||0.848|TWO_SIDED|95.0|-0.834|0.686||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.686|-0.834|0.848
91790300|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790301|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.38||0.869|TWO_SIDED|95.0|-0.81|0.684||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.684|-0.810|0.869
91790302|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790303|NCT02880956|183460050|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.389||0.679|TWO_SIDED|95.0|-0.603|0.925||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.603|0.679
91790304|NCT02880956|183460050|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|2.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790305|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.693||0.562|TWO_SIDED|95.0|-1.764|0.96||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.960|-1.764|0.562
91790306|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91592971|NCT01360554|183076946|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.497||||||95.0|-4.575|1.581|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 social functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.581|-4.575|
91592972|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2851|||||TWO_SIDED|95.0|-2.416|4.986|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Appetite loss. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.986|-2.416|
91592973|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-5.923|||||TWO_SIDED|95.0|-8.432|-3.414|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Constipation. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-3.414|-8.432|
91592974|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|20.2564|||||TWO_SIDED|95.0|16.874|23.639|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Diarrhea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||23.639|16.874|
91592975|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.5499|||||TWO_SIDED|95.0|-7.719|-1.381|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Dysponea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.381|-7.719|
91592976|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.6584|||||TWO_SIDED|95.0|-4.442|1.125|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Fatigue. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.125|-4.442|
91592977|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.1469||||||95.0|-3.056|2.762|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Financial Difficulties. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.762|-3.056|
91592978|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.8711|||||TWO_SIDED|95.0|-7.998|-1.745|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Insomnia. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.745|-7.998|
91592979|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.4924|||||TWO_SIDED|95.0|-2.485|1.5|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Nausea and Vomiting. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.500|-2.485|
91592980|NCT01360554|183076947|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.3096|||||TWO_SIDED|95.0|-2.646|3.265|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Pain. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.265|-2.646|
91613932|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.226||||0.0018|TWO_SIDED|95.0|0.089|0.575|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.575|0.089|0.0018
91782612|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.97|1.02||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.02|0.97|
91782613|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.98||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||0.98|0.93|
91782614|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
91782615|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.08|0.97|
91782616|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.95|
91782617|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.03|||||TWO_SIDED|90.0|0.97|1.09||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.09|0.97|
91782618|NCT02637037|183444411|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.07|0.95|
91782619|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.03|0.93|
91782620|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.9|1.06||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.90|
91782621|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.89|1.05||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.05|0.89|
91782622|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.95|||||TWO_SIDED|90.0|0.87|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.03|0.87|
91782623|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.07|0.96|
91782624|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.04|0.92|
91782625|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.0|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.06|0.95|
91592981|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|2.6381||||||95.0|0.172|5.104|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Trouble Swallowing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||5.104|0.172|
91592982|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.2504||||||95.0|-7.178|-1.322|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Coughing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.322|-7.178|
91592983|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|-1.0764||||||95.0|-3.997|1.845|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Haemoptysis as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.845|-3.997|
91592984|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|9.3545||||||95.0|6.211|12.497|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Sore Mouth as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||12.497|6.211|
91592985|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1762||||||95.0|-3.56|1.208|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Shortness of Breath as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.208|-3.560|
91521566|NCT00508261|182917710|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.61|||||TWO_SIDED|95.0|-0.36|4.64||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.||4.64|-0.36|
91521567|NCT00508261|182917710|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.7|||||TWO_SIDED|95.0|0.71|6.18||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.||6.18|0.71|
91592986|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.6378||||||95.0|-3.684|2.408|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Peripheral Neuropathy as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.408|-3.684|
91592987|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.3637||||||95.0|-4.546|1.819|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Alopecia as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.819|-4.546|
91592988|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.2163||||||95.0|-3.885|1.452|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Chest as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.452|-3.885|
91592989|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1475||||||95.0|-3.902|1.607|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Arm or Shoulder as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.607|-3.902|
91592990|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.0687||||||95.0|-4.488|2.351|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain Other Parts as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.351|-4.488|
91592991|NCT01360554|183076948|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.0322||||||95.0|-4.847|4.911|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Any Med for Pain as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.911|-4.847|
91592992|NCT01360554|183076949|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.3886||||||95.0|-2.413|1.636|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for EQ-5D VAS. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.636|-2.413|
91592993|NCT00674583|183076950|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-5.25|5.75||||||To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference \[Nimenrix group minus Menjugate group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||5.75|-5.25|
91592994|NCT00111800|183076960|SUPERIORITY||Mean Difference (Net)|-0.28||||0.061|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.58|0.061
91592995|NCT00111800|183076960|SUPERIORITY||Mean Difference (Net)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.82|-0.24|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.24|-0.82|<0.001
91592996|NCT00111800|183076960|SUPERIORITY||Mean Difference (Net)|-0.45||||0.002|TWO_SIDED|95.0|-0.74|-0.16|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.16|-0.74|0.002
91592997|NCT00111800|183076960|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.09|-0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.50|-1.09|<0.001
91592998|NCT00111800|183076960|SUPERIORITY||Mean Difference (Net)|-0.84|||<|0.001|TWO_SIDED|95.0|-1.13|-0.55|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.55|-1.13|<0.001
91592999|NCT00111800|183076962|SUPERIORITY||Mean Difference (Net)|-0.4||||0.306|TWO_SIDED|95.0|-1.18|0.37|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.37|-1.18|0.306
91593000|NCT00111800|183076962|SUPERIORITY||Mean Difference (Net)|-0.8||||0.039|TWO_SIDED|95.0|-1.56|-0.04|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.04|-1.56|0.039
91593001|NCT00111800|183076962|SUPERIORITY||Mean Difference (Net)|-0.58||||0.13|TWO_SIDED|95.0|-1.34|0.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.17|-1.34|0.130
91593002|NCT00111800|183076962|SUPERIORITY||Mean Difference (Net)|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.69|-2.23|<0.001
91593003|NCT00111800|183076962|SUPERIORITY||Mean Difference (Net)|-1.22||||0.002|TWO_SIDED|95.0|-1.99|-0.46|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.46|-1.99|0.002
91593004|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|0.92||||0.909|TWO_SIDED|95.0|0.21|3.95|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.95|0.21|0.909
91593005|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.27|4.92|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.92|0.27|0.852
91593006|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.2||||0.795|TWO_SIDED|95.0|0.3|4.83|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.83|0.30|0.795
91782626|NCT02637037|183444412|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.94|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.94|
91782627|NCT00638014|183444441|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
91782628|NCT01869764|183444482|OTHER|||||||0.93|||||||ANOVA|||||||0.93
91593007|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|2.68||||0.135|TWO_SIDED|95.0|0.74|9.77|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.77|0.74|0.135
91593008|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|3.24||||0.085|TWO_SIDED|95.0|0.85|12.37|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||12.37|0.85|0.085
91593009|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.1||||0.866|TWO_SIDED|95.0|0.36|3.36|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.36|0.36|0.866
91593010|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.99||||0.202|TWO_SIDED|95.0|0.69|5.76|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.76|0.69|0.202
91593011|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.04||||0.941|TWO_SIDED|95.0|0.35|3.13|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.13|0.35|0.941
91593012|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|2.15||||0.152|TWO_SIDED|95.0|0.76|6.13|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.13|0.76|0.152
91782629|NCT01869764|183444483|OTHER|||||||0.29|||||||ANOVA|||||||0.29
91782630|NCT04717336|183444509|SUPERIORITY||Mean of Paired Differences|0.002||||0.98|TWO_SIDED|95.0|-0.22|0.23|||Paired T-Test|A paired t-test was applied across both periods because this is a cross-over study where each participant serves at their own control.||The aim of this analysis is to test whether there is a statistically significant difference in Pulse Wave Velocity when participants are on sodium chloride vs. placebo, regardless of period.||0.23|-0.22|0.98
91521568|NCT00508261|182917711|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.97|||||TWO_SIDED|95.0|0.83|1.12||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.||1.12|0.83|
91521569|NCT00508261|182917711|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.||1.13|0.85|
91521570|NCT00508261|182917711|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.92|||||TWO_SIDED|95.0|0.78|1.1||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.||1.1|0.78|
91521571|NCT00508261|182917712|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.22|||||TWO_SIDED|95.0|-1.47|4.6||||||||4.6|-1.47|
91521572|NCT00508261|182917713|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.19|||||TWO_SIDED|95.0|-1.45|4.5||||||||4.5|-1.45|
91521573|NCT00180479|182917739|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.|||||<|0.0001|||||||t-test, 1 sided|||Primary endpoint analyzed for intent-to-treat \& per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.||||<0.0001
91593013|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|3.24||||0.032|TWO_SIDED|95.0|1.11|9.52|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.52|1.11|0.032
91593014|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|0.46||||0.198|TWO_SIDED|95.0|0.14|1.5|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||1.50|0.14|0.198
91593015|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.43||||0.481|TWO_SIDED|95.0|0.53|3.85|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.85|0.53|0.481
91593016|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.36|2.78|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||2.78|0.36|0.991
91593017|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|3.65||||0.008|TWO_SIDED|95.0|1.41|9.48|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.48|1.41|0.008
91593018|NCT00111800|183076964|SUPERIORITY||Odds Ratio (OR)|2.0||||0.161|TWO_SIDED|95.0|0.76|5.24|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c reduction \>=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.24|0.76|0.161
91593019|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|1.77||||0.38|TWO_SIDED|95.0|0.5|6.3|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.30|0.50|0.380
91593020|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|2.57||||0.145|TWO_SIDED|95.0|0.72|9.11|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.11|0.72|0.145
91593021|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|1.09||||0.906|TWO_SIDED|95.0|0.26|4.62|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.26|0.906
91593022|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|1.56||||0.509|TWO_SIDED|95.0|0.41|5.91|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.91|0.41|0.509
91593023|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|3.14||||0.077|TWO_SIDED|95.0|0.89|11.14|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||11.14|0.89|0.077
91593024|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|1.9||||0.254|TWO_SIDED|95.0|0.63|5.72|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.72|0.63|0.254
91593025|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|1.59||||0.396|TWO_SIDED|95.0|0.55|4.62|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.55|0.396
91593026|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|1.35||||0.59|TWO_SIDED|95.0|0.45|4.0|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.00|0.45|0.590
91593027|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|3.24||||0.026|TWO_SIDED|95.0|1.15|9.13|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.13|1.15|0.026
91593028|NCT00111800|183076965|SUPERIORITY||Odds Ratio (OR)|3.0||||0.034|TWO_SIDED|95.0|1.08|8.3|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||8.30|1.08|0.034
91593029|NCT00111800|183076966|SUPERIORITY||Mean Difference (Net)|-14.9||||0.057||95.0|-30.2|0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.5|-30.2|0.057
91593030|NCT00111800|183076966|SUPERIORITY||Mean Difference (Net)|-22.4||||0.003||95.0|-37.1|-7.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-7.6|-37.1|0.003
91593031|NCT00111800|183076966|SUPERIORITY||Mean Difference (Net)|-29.2|||<|0.001||95.0|-43.9|-14.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-14.5|-43.9|<0.001
91593032|NCT00111800|183076966|SUPERIORITY||Mean Difference (Net)|-39.6|||<|0.001|TWO_SIDED|95.0|-54.6|-24.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-24.6|-54.6|<0.001
91593033|NCT00111800|183076966|SUPERIORITY||Mean Difference (Net)|-38.9|||<|0.001|TWO_SIDED|95.0|-53.8|-23.9|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-23.9|-53.8|<0.001
91593034|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|-8.51||||0.489|TWO_SIDED|95.0|-32.66|15.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for fasting serum insulin.|Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||15.65|-32.66|0.489
91593035|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|14.18||||0.237|TWO_SIDED|95.0|-9.37|37.72|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for fasting serum insulin.|Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||37.72|-9.37|0.237
91782631|NCT02039843|183444510|SUPERIORITY|||||||0.052||||||Two-sided a priori alpha level was 0.05.|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in WHO-DAS score adjusted for gender, site, baseline score, time \& timeXgroup interaction||||||0.052
91782632|NCT02039843|183444511|SUPERIORITY|||||||0.421||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.421
91782633|NCT02039843|183444512|SUPERIORITY|||||||0.606||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in MCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.606
91782634|NCT02039843|183444513|SUPERIORITY|||||||0.21||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PSQI score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.210
91782635|NCT02039843|183444514|SUPERIORITY|||||||0.036||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCL-5 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.036
91782636|NCT02039843|183444515|SUPERIORITY|||||||0.079||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PHQ-9 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.079
91782637|NCT02039843|183444516|SUPERIORITY|||||||0.155||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in DAR score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.155
91782638|NCT02039843|183444517|SUPERIORITY|||||||0.157||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Generalized linear mixed repeated measures analysis on group difference in SBI adjusted for gender, site, baseline SBI, time, and timeXgroup||||||0.157
91593036|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|7.31||||0.534||95.0|-15.79|30.42|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for fasting serum insulin.|Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||30.42|-15.79|0.534
91593037|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|5.27||||0.665|TWO_SIDED|95.0|-18.64|29.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for fasting serum insulin.|Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||29.17|-18.64|0.665
91593038|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|12.74||||0.295|TWO_SIDED|95.0|-11.18|36.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for fasting serum insulin.|Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||36.65|-11.18|0.295
91593039|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|3.31||||0.327|TWO_SIDED|95.0|-3.32|9.94|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for pro-insulin.|Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.94|-3.32|0.327
91593040|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|3.06||||0.345|TWO_SIDED|95.0|-3.31|9.44|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for pro-insulin.|Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.44|-3.31|0.345
91593041|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|-0.35||||0.914|TWO_SIDED|95.0|-6.7|6.0|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for pro-insulin.|Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.00|-6.70|0.914
91593042|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|-2.21||||0.504|TWO_SIDED|95.0|-8.71|4.29|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for pro-insulin.|Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.29|-8.71|0.504
91782639|NCT02039843|183444518|SUPERIORITY|||||||0.43||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.430
91782640|NCT02039843|183444519|SUPERIORITY|||||||0.358||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.358
91782641|NCT02039843|183444520|SUPERIORITY|||||||0.39||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.39
91782642|NCT02039843|183444530|SUPERIORITY|||||||0.383||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.383
91782643|NCT02039843|183444531|SUPERIORITY|||||||0.932|||||||Regression, Linear|||||||0.932
91782644|NCT01958164|183444536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|73.3|||||TWO_SIDED|95.0|23.3|89.3|||||Difference calculated as actilyse minus saline solution|||89.3|23.3|
91782645|NCT01958164|183444537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||||TWO_SIDED|95.0|20.7|90.3|||||Difference calculated as actilyse minus saline solution|||90.3|20.7|
91782646|NCT00740857|183444541|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
91782647|NCT00740857|183444541|SUPERIORITY_OR_OTHER|||||||0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||0.001
91782648|NCT00740857|183444541|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
91782649|NCT00740857|183444542|SUPERIORITY_OR_OTHER|||||||0.118|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.118
91593043|NCT00111800|183076968|SUPERIORITY||Mean Difference (Net)|2.75||||0.403|TWO_SIDED|95.0|-3.71|9.22|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for pro-insulin.|Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.22|-3.71|0.403
91593044|NCT00111800|183076971|SUPERIORITY||Mean Difference (Net)|0.03||||0.286|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.08|-0.02|0.286
91593045|NCT00111800|183076971|SUPERIORITY||Mean Difference (Net)|-0.02||||0.457|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.03|-0.07|0.457
91593046|NCT00111800|183076971|SUPERIORITY||Mean Difference (Net)|-0.04||||0.136|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.136
91593047|NCT00111800|183076971|SUPERIORITY||Mean Difference (Net)|-0.06||||0.021|TWO_SIDED|95.0|-0.11|-0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.01|-0.11|0.021
91593048|NCT00111800|183076971|SUPERIORITY||Mean Difference (Net)|-0.04||||0.094|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.094
91593049|NCT02752035|183076999|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.523|TWO_SIDED|95.0|0.57|1.329|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.329|0.570|0.523
91593050|NCT02752035|183077000|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.787|TWO_SIDED|95.0|0.635|1.393|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.393|0.635|0.787
91593051|NCT02752035|183077002|SUPERIORITY||Treatment Difference|8.2||||0.249|TWO_SIDED|95.0|-6.5|23.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||23.0|-6.5|0.249
91593052|NCT02752035|183077003|SUPERIORITY||Treatment Difference|33.3|||<|0.001|TWO_SIDED|95.0|16.6|50.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||50.0|16.6|<0.001
91593053|NCT02752035|183077004|SUPERIORITY||Treatment Difference|8.5||||0.049|TWO_SIDED|95.0|-0.1|17.1||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||17.1|-0.1|0.049
91593054|NCT02752035|183077005|SUPERIORITY||Treatment Difference|16.7||||0.032|TWO_SIDED|95.0|1.1|32.4||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||32.4|1.1|0.032
91593055|NCT02752035|183077006|SUPERIORITY||Treatment Difference|-9.0||||0.34|TWO_SIDED|95.0|-29.8|11.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||11.0|-29.8|0.340
91593056|NCT02752035|183077007|SUPERIORITY||Treatment Difference|50.0||||0.221|TWO_SIDED|95.0|-61.0|100.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||100.0|-61.0|0.221
91593057|NCT02752035|183077008|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.592|TWO_SIDED|95.0|0.451|1.58|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|||1.580|0.451|0.592
91593058|NCT02752035|183077009|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.3|TWO_SIDED|95.0|0.198|1.658|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR/CRh.||1.658|0.198|0.300
91593059|NCT02752035|183077009|SUPERIORITY||Hazard Ratio (HR)|0.411||||0.171|TWO_SIDED|95.0|0.113|1.504|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR.||1.504|0.113|0.171
91593060|NCT02752035|183077009|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.383|TWO_SIDED|95.0|0.295|1.62|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRc||1.620|0.295|0.383
91593061|NCT02752035|183077009|SUPERIORITY||Hazard Ratio (HR)|999.0||||0.998|TWO_SIDED|95.0|0.001||Upper limit of 95% confidence interval was not estimable due to insufficient number of participants.||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRh.|||0.001|0.998
91593062|NCT02752035|183077009|SUPERIORITY||Hazard Ratio (HR)|0.628||||0.174|TWO_SIDED|95.0|0.321|1.229|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of response.||1.229|0.321|0.174
91782650|NCT00740857|183444542|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60....||||<0.001
91782651|NCT00740857|183444543|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.041
91782652|NCT00740857|183444543|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
91648498|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0||||0.018|TWO_SIDED|95.0|1.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||7.6|1.2|0.018
91648499|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.4||||0.008|TWO_SIDED|95.0|1.4|8.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||8.6|1.4|0.008
91648500|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1||||0.129|TWO_SIDED|95.0|0.8|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||5.6|0.8|0.129
91648501|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9||||0.003|TWO_SIDED|95.0|1.4|5.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.9|1.4|0.003
91648502|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8||||0.005|TWO_SIDED|95.0|1.4|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.6|1.4|0.005
91648503|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||7.3|1.8|<0.001
91648504|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.018|TWO_SIDED|95.0|1.1|4.1||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||4.1|1.1|0.018
91648505|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
91521574|NCT00180479|182917740|NON_INFERIORITY_OR_EQUIVALENCE|Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.|||||<|0.0001|||||||t-test, 1 sided|||Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.||||<0.0001
91782653|NCT00740857|183444544|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
91782654|NCT00740857|183444545|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.056
91782655|NCT00740857|183444545|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
91782656|NCT00740857|183444546|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
91782657|NCT00740857|183444547|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
91782658|NCT00740857|183444548|SUPERIORITY_OR_OTHER||||||<|0.001|||||||proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
91782659|NCT02963506|183444549|OTHER||Correlation statistic|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|||Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.||||<0.001
91782660|NCT02963506|183444549|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|2.6|||=|0.04|TWO_SIDED|95.0|1.04|6.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.||6.48|1.04|=0.040
91782661|NCT02963506|183444549|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.5|||=|0.001|TWO_SIDED|95.0|1.83|10.86||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||10.86|1.83|=0.001
91593063|NCT02752035|183077010|SUPERIORITY||Least square mean difference|0.5||||0.56|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|Using analysis of covariance including treatment, age group per IRT and baseline score as covariate.|Least square mean difference and P-value were calculated using AZA as reference.|||2.0|-1.1|0.560
91593064|NCT01263483|183077019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.002|||||TWO_SIDED|95.0|-1.166|-0.838||||||||-0.838|-1.166|
91593065|NCT01263483|183077019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.947|||||TWO_SIDED|95.0|-1.097|-0.796||||||||-0.796|-1.097|
91593066|NCT01263483|183077020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|||||TWO_SIDED|95.0|-0.229|-0.123||||||||-0.123|-0.229|
91593067|NCT01263483|183077020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.247|-0.133||||||||-0.133|-0.247|
91593068|NCT01263483|183077021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.421|||||TWO_SIDED|95.0|-0.507|-0.334||||||||-0.334|-0.507|
91593069|NCT01263483|183077021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|||||TWO_SIDED|95.0|-0.504|-0.324||||||||-0.324|-0.504|
91593070|NCT01263483|183077022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.738|||||TWO_SIDED|95.0|-0.871|-0.605||||||||-0.605|-0.871|
91593071|NCT01263483|183077022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.749|||||TWO_SIDED|95.0|-0.875|-0.623||||||||-0.623|-0.875|
91593072|NCT01263483|183077023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.01|||||TWO_SIDED|95.0|-18.5|-5.52||||||||-5.52|-18.50|
91593073|NCT01263483|183077023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.33|||||TWO_SIDED|95.0|-21.93|-8.73||||||||-8.73|-21.93|
91593074|NCT01263483|183077024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65|||||TWO_SIDED|95.0|-23.02|-8.27||||||||-8.27|-23.02|
91593075|NCT01263483|183077024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.03|||||TWO_SIDED|95.0|-29.68|-14.38||||||||-14.38|-29.68|
91593076|NCT01263483|183077025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3|||||TWO_SIDED|95.0|-26.09|-10.5||||||||-10.50|-26.09|
91593077|NCT01263483|183077025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-27.34|-11.34||||||||-11.34|-27.34|
91593078|NCT01263483|183077026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.53|||||TWO_SIDED|95.0|-21.46|-5.6||||||||-5.60|-21.46|
91593079|NCT01263483|183077026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.97|||||TWO_SIDED|95.0|-21.53|-4.41||||||||-4.41|-21.53|
91593080|NCT01263483|183077027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.304|0.104||||||||0.104|-0.304|
91593081|NCT01263483|183077027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|||||TWO_SIDED|95.0|-0.239|0.167||||||||0.167|-0.239|
91593082|NCT01263483|183077028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|||||TWO_SIDED|95.0|-0.267|0.292||||||||0.292|-0.267|
91593083|NCT01263483|183077028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|||||TWO_SIDED|95.0|-0.264|0.196||||||||0.196|-0.264|
91593084|NCT01263483|183077029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||||TWO_SIDED|95.0|-0.268|0.191||||||||0.191|-0.268|
91593085|NCT01263483|183077029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||||TWO_SIDED|95.0|-0.261|0.115||||||||0.115|-0.261|
91593086|NCT01263483|183077030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.183|0.252||||||||0.252|-0.183|
91593087|NCT01263483|183077030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||||TWO_SIDED|95.0|-0.124|0.288||||||||0.288|-0.124|
91593088|NCT01263483|183077031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.54|||||TWO_SIDED|95.0|-41.28|-21.8||||||||-21.80|-41.28|
91593089|NCT01263483|183077031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||||TWO_SIDED|95.0|-44.88|-22.57||||||||-22.57|-44.88|
91593090|NCT01263483|183077032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.38|||||TWO_SIDED|95.0|-90.67|-50.09||||||||-50.09|-90.67|
91593091|NCT01263483|183077032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.49|||||TWO_SIDED|95.0|-93.1|-51.88||||||||-51.88|-93.10|
91593092|NCT01263483|183077033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.093|||||TWO_SIDED|95.0|2.229|11.958||||||||11.958|2.229|
91593093|NCT01263483|183077033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.967|||||TWO_SIDED|95.0|-0.521|8.455||||||||8.455|-0.521|
91593094|NCT01263483|183077034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.045|1.144||||||||1.144|-0.045|
91593095|NCT01263483|183077034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.428|||||TWO_SIDED|95.0|-0.233|1.09||||||||1.090|-0.233|
91648506|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6|||Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
91648507|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.042|TWO_SIDED|95.0|1.0|3.4||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||3.4|1.0|0.042
91593096|NCT01263483|183077035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.77|||||TWO_SIDED|95.0|-36.65|-0.9||||||||-0.90|-36.65|
91593097|NCT01263483|183077035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.04|||||TWO_SIDED|95.0|-37.82|-2.27||||||||-2.27|-37.82|
91593098|NCT01131676|183077040|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.02|0.74|0.99||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||0.99|0.74|<0.0001
91593099|NCT01131676|183077040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0382|TWO_SIDED|95.02|0.74|0.99||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.99|0.74|0.0382
91593100|NCT01131676|183077041|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.02|0.78|1.01||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|<0.0001
91782662|NCT02963506|183444549|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|2.27|13.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||13.48|2.27|<0.001
91782663|NCT02963506|183444549|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.3|||<|0.001|TWO_SIDED|95.0|2.19|12.92||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||12.92|2.19|<0.001
91782664|NCT02963506|183444550|OTHER||LS Mean Difference vs placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.86|-0.24|||ANCOVA|||Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.24|-0.86|<0.001
91593101|NCT01131676|183077041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0795|TWO_SIDED|95.02|0.78|1.01||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|0.0795
91593102|NCT01131676|183077042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.4172|TWO_SIDED|95.0|0.7|2.33||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||2.33|0.70|0.4172
91782665|NCT02963506|183444550|OTHER||LS Mean Difference vs placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.47|-0.83|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.83|-1.47|<0.001
91782666|NCT02963506|183444550|OTHER||LS Mean Difference vs placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.72|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.72|-1.35|<0.001
91782667|NCT02963506|183444550|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.45|-0.82|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.82|-1.45|<0.001
91782668|NCT02963506|183444551|OTHER||Odds Ratio (OR)|1.7|||=|0.163|TWO_SIDED|95.0|0.8|3.67||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||3.67|0.80|=0.163
91782669|NCT02963506|183444551|OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.84|8.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||8.48|1.84|<0.001
91782670|NCT02963506|183444551|OTHER||Odds Ratio (OR)|3.5|||=|0.001|TWO_SIDED|95.0|1.66|7.61||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||7.61|1.66|=0.001
91782671|NCT02963506|183444551|OTHER||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|2.92|14.28||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||14.28|2.92|<0.001
91782672|NCT02963506|183444552|OTHER||Odds Ratio (OR)|5.3|||=|0.003|TWO_SIDED|95.0|1.74|15.96||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||15.96|1.74|=0.003
91782673|NCT02963506|183444552|OTHER||Odds Ratio (OR)|11.9|||<|0.001|TWO_SIDED|95.0|4.03|35.38||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||35.38|4.03|<0.001
91782674|NCT02963506|183444552|OTHER||Odds Ratio (OR)|14.3|||<|0.001|TWO_SIDED|95.0|4.81|42.46||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||42.46|4.81|<0.001
91782675|NCT02963506|183444552|OTHER||Odds Ratio (OR)|14.9|||<|0.001|TWO_SIDED|95.0|5.02|44.27||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||44.27|5.02|<0.001
91782676|NCT02963506|183444553|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.094|TWO_SIDED|95.0|-1.31|0.1|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.10|-1.31|=0.094
91782677|NCT02963506|183444553|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.34|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.34|<0.001
91782678|NCT02963506|183444553|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.35|<0.001
91782679|NCT02963506|183444553|OTHER||LS Mean Difference vs placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.6|-1.18|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-1.18|-2.60|<0.001
91782680|NCT02963506|183444554|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.075|TWO_SIDED|95.0|-1.35|0.07|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.07|-1.35|=0.075
91593103|NCT01131676|183077043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.5|0.85||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.85|0.50|0.0017
91593104|NCT01131676|183077044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2547|TWO_SIDED|95.0|0.87|1.04||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||1.04|0.87|0.2547
91593105|NCT01131676|183077045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.72||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.72|0.54|<0.0001
91593106|NCT01131676|183077046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.70|0.54|<0.0001
91593107|NCT02577406|183077049|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2288|TWO_SIDED|95.0|0.67|1.1|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory|||1.10|0.67|0.2288
91593108|NCT02577406|183077050|SUPERIORITY||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.14||p-value from a Cochran-Mantel-Haenszel test comparing the response rates between the AG-221 group and the combined CCR group with stratification factors of prior intensive therapy for AML and primary refractory status|Cochran-Mantel-Haenszel||Odds ratio from logistic regression|||11.14|3.32|<0.0001
91648508|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|1.7|5.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.8|1.7|<0.001
91648509|NCT01244815|183189701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001||95.0|1.6|5.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.3|1.6|<0.001
91709202|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.73||||0.19|TWO_SIDED|95.0|0.46|1.17|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.17|0.46|0.190
91593109|NCT02577406|183077051|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.02|TWO_SIDED|95.0|0.55|0.95|||Stratified Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status.|||0.95|0.55|0.0200
91593110|NCT02577406|183077057|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91593111|NCT02577406|183077058|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91593112|NCT02577406|183077059|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91593113|NCT02577406|183077061|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.67|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status|||0.67|0.41|<0.0001
91593114|NCT01111851|183077077|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS Means|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.01|0.99|
91709203|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.856|TWO_SIDED|95.0|0.56|1.61|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.61|0.56|0.856
91593115|NCT01111851|183077078|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.98|1.02|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.02|0.98|
91593116|NCT01111851|183077079|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.03|0.97|
91593117|NCT01111851|183077080|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|0.91|||||TWO_SIDED|90.0|0.5|1.66|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.66|0.50|
91593118|NCT01961349|183077094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91593119|NCT01961349|183077094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91593120|NCT01961349|183077095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91593121|NCT01961349|183077095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91593122|NCT02901574|183077125|SUPERIORITY||Mean Difference (Final Values)|3.87||||0.24|TWO_SIDED|95.0|-2.55|10.3||Threshold for significance is two-sided alpha of 0.05.|Mixed Models Analysis|||||10.30|-2.55|0.24
91593123|NCT00073528|183077139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio wase based on the log-rank test.|||0.96|0.53|0.019
91593124|NCT00073528|183077140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio was based on the log-rank test.|||0.96|0.53|0.019
91593125|NCT04037748|183077179|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|90.8|||||TWO_SIDED|90.0|86.3|95.6||||||||95.6|86.3|
91593126|NCT04037748|183077180|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|93.7|||||TWO_SIDED|90.0|88.2|99.5||||||||99.5|88.2|
91593127|NCT04037748|183077182|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|97.3|||||TWO_SIDED|90.0|94.7|100.0||||||||100.0|94.7|
91593128|NCT04037748|183077183|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|94.82|||||TWO_SIDED|90.0|92.0|97.8||||||||97.8|92.0|
91593129|NCT01854645|183077188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
91593130|NCT01854645|183077188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
91593131|NCT01854645|183077188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
91593132|NCT01854645|183077188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
91593133|NCT01854645|183077188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
91593134|NCT01854645|183077188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
91593135|NCT02064920|183077190|SUPERIORITY_OR_OTHER||Change in SD from Week 4 to Week 16|0.005|||||TWO_SIDED|95.0|-0.031|0.039|||||SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.|Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined||0.039|-0.031|
91613933|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.529||||0.0083|TWO_SIDED|95.0|1.116|2.097|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.097|1.116|0.0083
91613934|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.285||||0.0028|TWO_SIDED|95.0|1.09|1.515|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.515|1.090|0.0028
91613935|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.061||||0.0002|TWO_SIDED|95.0|1.401|3.032|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.032|1.401|0.0002
91613936|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327||||0.0019|TWO_SIDED|95.0|0.162|0.662|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.662|0.162|0.0019
91613937|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0086|TWO_SIDED|95.0|0.137|0.749|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.749|0.137|0.0086
91613938|NCT01070550|183121726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247|||<|0.0001|TWO_SIDED|95.0|0.138|0.441|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.441|0.138|<0.0001
91613939|NCT01505491|183121767|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|113.22|STANDARD_ERROR_OF_MEAN|1.086||0.1163|TWO_SIDED|90.0|98.752|129.812|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||129.812|98.752|0.1163
91593136|NCT02109562|183077192|SUPERIORITY||Mean Difference (Final Values)|-6.148|STANDARD_ERROR_OF_MEAN|1.7261||0.0004|TWO_SIDED|95.0|-9.982|-2.314||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-2.314|-9.982|0.0004
91593137|NCT02109562|183077192|SUPERIORITY||Mean Difference (Final Values)|-7.237|STANDARD_ERROR_OF_MEAN|1.7141|<|0.0001|TWO_SIDED|95.0|-11.045|-3.429||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-3.429|-11.045|<0.0001
91593138|NCT02109562|183077193|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0934||0.0002|TWO_SIDED|95.0|-0.557|-0.143||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.143|-0.557|0.0002
91593139|NCT02109562|183077193|SUPERIORITY||Mean Difference (Final Values)|-0.396|STANDARD_ERROR_OF_MEAN|0.0928|<|0.0001|TWO_SIDED|95.0|-0.602|-0.19||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.190|-0.602|<0.0001
91593140|NCT03023930|183077195|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|proc logistic||||||<0.001
91593141|NCT03023930|183077196|SUPERIORITY|||||||0.011|||||||Regression, Logistic|proc logistic||||||0.011
91648510|NCT01244815|183189702|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25||||0.014|TWO_SIDED|95.0|-0.45|-0.05|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.05|-0.45|0.014
91521575|NCT03315143|182917793|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.88|0.63|<0.001
91593142|NCT00262522|183077232|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.||||>0.100
91593143|NCT00262522|183077233|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|1.3||||0.715||95.0|-5.1|7.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||7.8|-5.1|0.715
91593144|NCT00262522|183077234|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|-4.3||||0.249||95.0|-11.5|2.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||2.8|-11.5|0.249
91593145|NCT00262522|183077235|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANOVA|||||||0.269
91593146|NCT04272892|183077236|SUPERIORITY||Mean Difference (Final Values)|3.35|||<|0.021|TWO_SIDED|||||p values are calculated for original data (complete case) and each of the 5 imputed datasets. The p value range was 0.002 - 0.020. This is not multiple statistical analyses- it is just one with multiple imputations.|ANCOVA|Degrees of freedom for original data (complete case): 1,64. Degrees of freedom for imputed datasets: 1,80||||||<0.021
91593147|NCT04272892|183077237|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.059|TWO_SIDED|95.0|-0.106|5.822|||ANCOVA|ANCOVA of score at 8 week follow up with baseline score as covariate, effect of group||||5.822|-.106|0.059
91593148|NCT04272892|183077238|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.596|TWO_SIDED|95.0|-3.5|6.0|||ANCOVA|ANCOVA of sleep fragmentation at post-intervention with baseline as covariate, effect of group||||6.0|-3.5|0.596
91593149|NCT04272892|183077239|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.031|TWO_SIDED|95.0|0.431|8.612|||ANCOVA|ANCOVA of sleep fragmentation at 8 week follow up with baseline as covariate, effect of group||||8.612|.431|0.031
91593150|NCT04272892|183077240|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.885|TWO_SIDED|95.0|-7.8|9.1|||ANCOVA|ANCOVA of wake after sleep onset post-intervention with baseline as covariate, effect of group||||9.1|-7.8|0.885
91648511|NCT01244815|183189702|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17||||0.107|TWO_SIDED|95.0|-0.37|0.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.04|-0.37|0.107
91593151|NCT04272892|183077241|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|17.0|||ANCOVA|ANCOVA of wake after sleep onset at 8 week follow up with baseline as covariate, effect of group||||17|-1|0.077
91593152|NCT04272892|183077242|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.014|TWO_SIDED|95.0|2.0|18.0|||ANCOVA|ANCOVA of sleep onset latency (median of 7 nights) at end of intervention with baseline as covariate, effect of group||||18|2|0.014
91593153|NCT04272892|183077243|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.03|TWO_SIDED|95.0|0.18|3.5|||ANCOVA|ANCOVA of PHQ9 score post-intervention with baseline as covariate, effect of group||||3.5|.18|0.03
91593154|NCT04272892|183077244|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.036|TWO_SIDED|95.0|0.149|4.44|||ANCOVA|ANCOVA of PHQ9 score at 8 week follow up with baseline as covariate, effect of group||||4.44|.149|0.036
91648512|NCT01244815|183189702|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.039|TWO_SIDED|95.0|-0.42|-0.01|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.01|-0.42|0.039
91782681|NCT02963506|183444554|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.003|TWO_SIDED|95.0|-1.79|-0.37|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.37|-1.79|=0.003
91593155|NCT04272892|183077245|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.054|TWO_SIDED|95.0|-0.03|3.25|||ANCOVA|ANCOVA of GAD7 post-intervention, with baseline as covariate, effect of group||||3.25|-0.03|0.054
91593156|NCT04272892|183077246|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.229|TWO_SIDED|95.0|-0.7|2.87|||ANCOVA|ANCOVA of GAD7 at 8 week follow up, with baseline as covariate, effect of group||||2.87|-.70|0.229
91593157|NCT04272892|183077247|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.502|TWO_SIDED|95.0|-5.51|2.73|||ANCOVA|ANCOVA of SIS index at post-intervention, with baseline as covariate, effect of group||||2.73|-5.51|0.502
91593158|NCT04272892|183077248|SUPERIORITY||Mean Difference (Final Values)|0.183||||0.924|TWO_SIDED|95.0|-3.63|4.0|||ANCOVA|ANCOVA of SIS index at 8 week follow up, with baseline as covariate, effect of group||||4.0|-3.63|0.924
91593159|NCT05318937|183077255|SUPERIORITY||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|2.07||0.9934|TWO_SIDED|95.0|-4.13|4.09||The p-value was obtained using a MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MMRM||Difference was calculated as SAGE-718 - placebo.|||4.09|-4.13|0.9934
91782682|NCT02963506|183444554|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.002|TWO_SIDED|95.0|-1.84|-0.42|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.42|-1.84|=0.002
91782683|NCT02963506|183444554|OTHER||LS Mean Difference vs placebo|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.22|-0.81|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.81|-2.22|<0.001
91593160|NCT04722042|183077259|SUPERIORITY|||||||0.557|||||||ANOVA|||comparison of word recognition over time (activation, and 1, 3, 6, and 12 months post-activation) between groups (default versus place-based)||||0.557
91593161|NCT04722042|183077260|SUPERIORITY|||||||0.208|||||||ANOVA|||comparison of spatial release from masking over time (1, 3, 6, and 12 months post-activation) between the groups (default versus place-based)||||0.208
91593162|NCT04722042|183077261|SUPERIORITY|||||||0.126|||||||ANOVA|||comparison of spatial release from masking between the groups over time||||0.126
91593163|NCT04722042|183077262|SUPERIORITY|||||||0.369|||||||ANOVA|||comparison of perceived benefit between the groups over time||||0.369
91593164|NCT04722042|183077263|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91782684|NCT01724346|183444558|SUPERIORITY||Hazard Ratio (HR)|0.155|||<|0.0001|TWO_SIDED|95.0|0.11|0.22||P-value is from stratified log-rank test.|Log Rank|||||0.220|0.110|< 0.0001
91782685|NCT01724346|183444561|SUPERIORITY||Hazard Ratio (HR)|0.087|||<|0.0001|TWO_SIDED|95.0|0.054|0.141||P value is from stratified log-rank test.|Log Rank|||||0.141|0.054|< 0.0001
91782686|NCT01724346|183444562|SUPERIORITY||Rate ratio|2.496|||<|0.0001|TWO_SIDED|95.0|1.99|3.131||Rate ratio and p-value are based on Cochran-Mantel-Haenszel chi-square test stratified by Eastern Cooperative Oncology Group (ECOG; 0-1 vs 2) and Rai stage (0/I/II vs III/IV) at baseline.|Cochran-Mantel-Haenszel|||||3.131|1.990|< 0.0001
91593165|NCT04722042|183077264|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91593166|NCT04722042|183077265|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91593167|NCT01877915|183077273|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.27|TWO_SIDED|95.0|0.84|1.05|||Log Rank|||Statistical Analysis 1||1.05|0.84|0.270
91593168|NCT01877915|183077279|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.951|TWO_SIDED|95.0|0.41|2.59|||Log Rank|||Statistical Analysis 1 (Fatal Bleeding)||2.59|0.41|0.951
91593169|NCT01877915|183077279|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.253|TWO_SIDED|95.0|0.33|1.34|||Log Rank|||Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)||1.34|0.33|0.253
91593170|NCT05314517|183077303|OTHER||Stratified Common Risk Difference|14.1||||0.1244|TWO_SIDED|90.0|-1.0|29.2|||Cochran-Mantel-Haenszel|||||29.2|-1.0|0.1244
91521576|NCT03315143|182917794|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.55|0.82|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.82|0.55|<0.001
91521577|NCT03315143|182917795|SUPERIORITY||Hazard Ratio (HR)|0.9|||=|0.35|TWO_SIDED|95.0|0.73|1.12|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.12|0.73|=0.35
91521578|NCT03315143|182917796|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.63|0.83||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.63|
91521579|NCT03315143|182917797|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.89|0.65|
91593171|NCT04714073|183077312|OTHER||Ratio of geometric means (%)|218.81|||||TWO_SIDED|90.0|194.06|246.72|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||246.72|194.06|
91593172|NCT04714073|183077313|OTHER||Ratio of geometric means (%)|156.29|||||TWO_SIDED|90.0|135.04|180.89|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 22.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||180.89|135.04|
91521580|NCT03315143|182917798|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.08||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.08|0.46|
91521581|NCT03315143|182917799|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.18|0.83|
91521582|NCT03315143|182917800|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.91|0.65|
91613940|NCT01505491|183121767|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|132.24|STANDARD_ERROR_OF_MEAN|1.094||0.7345|TWO_SIDED|90.0|113.984|153.412|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||153.412|113.984|0.7345
91521583|NCT00840801|182917801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).|||||<|0.001|||||||Stratified score test|||Non-inferiority Test on Seropositive Response Rate||||<0.001
91521584|NCT00335452|182917816|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|6.1||||0.3037|TWO_SIDED|95.0|-5.8|16.6||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||16.6|-5.8|0.3037
91521585|NCT00335452|182917817|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).||||||0.012
91521586|NCT00335452|182917818|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|3.1||||0.6047|TWO_SIDED|95.0|-9.2|14.0||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.|The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.|||14.0|-9.2|0.6047
91521587|NCT00335452|182917819|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|-6.5||||0.4579|TWO_SIDED|95.0|-26.0|9.9||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||9.9|-26.0|0.4579
91521588|NCT00335452|182917819|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|17.6||||0.0262|TWO_SIDED|95.0|2.2|30.5||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||30.5|2.2|0.0262
91521589|NCT00335452|182917819|SUPERIORITY_OR_OTHER|||||||0.0355||95.0||||The a priori threshold for statistical significance is ≤0.05.|Chi-squared|Interaction chi-squared test of the Cox proportional hazards model.||||||0.0355
91521590|NCT00335452|182917820|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|14.7||||0.0332|TWO_SIDED|95.0|1.2|26.3||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||26.3|1.2|0.0332
91521591|NCT00335452|182917821|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).||||||0.945
91521592|NCT00335452|182917822|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|32.6||||0.0004|TWO_SIDED|95.0|16.2|45.8||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||45.8|16.2|0.0004
91521593|NCT02736825|182917823|NON_INFERIORITY|Non-inferiority margin of 15% between two independent percentages using the z-test with unpooled variance||||||0.367|||||||Z-test|||||||0.3670
91521594|NCT02901626|182917842|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.83|1.2||||||||1.20|0.83|
91521595|NCT02901626|182917843|SUPERIORITY||Median Difference (Net)|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||||8|-4|
91521596|NCT02901626|182917844|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.06|0.8||||||||0.80|-1.06|
91521597|NCT02901626|182917845|SUPERIORITY||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.92|1.71||||||||1.71|0.92|
91521598|NCT02901626|182917846|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.93|1.55||||||||1.55|0.93|
91521599|NCT02901626|182917847|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.93|1.45||||||||1.45|0.93|
91521600|NCT02901626|182917848|SUPERIORITY||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.92|1.82||||||||1.82|0.92|
91521601|NCT02901626|182917849|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
91521602|NCT02901626|182917850|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.61|2.39||||||||2.39|0.61|
91521603|NCT02901626|182917851|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.79|1.31||||||||1.31|0.79|
91521604|NCT02901626|182917852|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.55|2.04||||||||2.04|0.55|
91521605|NCT02901626|182917853|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
91521606|NCT02901626|182917854|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.95|1.94||||||||1.94|0.95|
91521607|NCT02901626|182917855|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.0|2.11||||||||2.11|1.00|
91521608|NCT02901626|182917856|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||||1.18|0.88|
91521609|NCT02901626|182917857|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|-12.0|12.0||||||||12|-12|
91521610|NCT02901626|182917858|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
91521611|NCT02901626|182917859|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-12.0|14.0||||||||14|-12|
91521612|NCT02901626|182917860|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.06|15.7||||||||15.7|0.06|
91521613|NCT02901626|182917861|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.25|2.65||||||||2.65|0.25|
91521614|NCT02901626|182917862|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.17|1.9||||||||1.90|0.17|
91521615|NCT02901626|182917863|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.68|1.96||||||||1.96|0.68|
91521616|NCT02901626|182917864|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.71|1.27||||||||1.27|0.71|
91521617|NCT02901626|182917865|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.37|1.41||||||||1.41|0.37|
91521618|NCT02901626|182917866|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.39|3.37||||||||3.37|0.39|
91521619|NCT02901626|182917867|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.78|1.29||||||||1.29|0.78|
91521620|NCT02901626|182917868|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||||1.10|0.58|
91521621|NCT02901626|182917869|SUPERIORITY||Risk Ratio (RR)|2.45|||||TWO_SIDED|95.0|0.48|12.57||||||||12.57|0.48|
91521622|NCT02901626|182917870|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.27|1.58||||||||1.58|0.27|
91521623|NCT02901626|182917871|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.47|0.97||||||||0.97|0.47|
91521624|NCT02901626|182917872|SUPERIORITY||Risk Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.09|2.66||||||||2.66|0.09|
91521625|NCT02901626|182917873|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.81|1.37||||||||1.37|0.81|
91521626|NCT02901626|182917874|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
91521627|NCT02901626|182917875|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|-16.0|36.0||||||||36|-16|
91521628|NCT03662074|182917887|OTHER||||||||||||||||||The pre-specified analysis plan as per the protocol is to proceed to the second stage of recruitment for additional participants if the response proportion exceeds the historical control of 10%.|||
91521629|NCT01446666|182917908|SUPERIORITY||||||<|0.01|||||||McNemar|||The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.||||<0.01
91521630|NCT01446666|182917909|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
91613941|NCT01505491|183121767|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.51|STANDARD_ERROR_OF_MEAN|1.09||0.1833|TWO_SIDED|90.0|74.974|99.83|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||99.830|74.974|0.1833
91521631|NCT01446666|182917910|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
91521632|NCT01446666|182917911|SUPERIORITY|||||||0.004|||||||McNemar|||||||0.004
91521633|NCT03701399|182917932|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7581|TWO_SIDED|95.0|-0.47|0.34|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country, baseline score as a covariate|All SCA participants||0.34|-0.47|0.7581
91782687|NCT00298558|183444593|SUPERIORITY_OR_OTHER||Effect Size|0.06||||0.43|TWO_SIDED|99.0|-0.14|0.27|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.27|-0.14|0.43
91782688|NCT00298558|183444593|SUPERIORITY_OR_OTHER||Effect Size|-0.11||||0.17|TWO_SIDED|99.0|-0.31|0.1|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.10|-0.31|0.17
91782689|NCT00298558|183444593|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.52|TWO_SIDED|99.0|-0.25|0.15|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.15|-0.25|0.52
91782690|NCT00298558|183444596|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.69|TWO_SIDED|99.0|-0.17|0.12|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.12|-0.17|0.69
91782691|NCT00298558|183444596|SUPERIORITY_OR_OTHER||Effect Size|0.23|||<|0.01|TWO_SIDED|99.0|0.09|0.38|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.38|0.09|<0.01
91782692|NCT00298558|183444596|SUPERIORITY_OR_OTHER||Effect Size|-0.06||||0.27|TWO_SIDED|99.0|-0.2|0.08|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.08|-0.20|0.27
91782693|NCT00298558|183444598|SUPERIORITY_OR_OTHER||Effect Size|-0.07||||0.45|TWO_SIDED|99.0|-0.29|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.29|0.45
91782694|NCT00298558|183444598|SUPERIORITY_OR_OTHER||Effect Size|0.005||||0.95|TWO_SIDED|99.0|-0.22|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.22|0.95
91782695|NCT00298558|183444598|SUPERIORITY_OR_OTHER||Effect Size|0.66|||<|0.01|TWO_SIDED|99.0|0.43|0.88|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.88|0.43|<0.01
91593173|NCT04714073|183077314|OTHER||Ratio of geometric means (%)|223.12|||||TWO_SIDED|90.0|198.61|250.66|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 17.5."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||250.66|198.61|
91593174|NCT02603120|183077343|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|0.7|||||TWO_SIDED|95.002|-1.0|2.8|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.8|-1.0|
91593175|NCT02603120|183077343|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
91782696|NCT00298558|183444599|SUPERIORITY_OR_OTHER||Effect Size|0.48|||<|0.01|TWO_SIDED|99.0|0.12|0.84|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.84|0.12|<0.01
91782697|NCT00298558|183444599|SUPERIORITY_OR_OTHER||Effect Size|0.38|||<|0.01|TWO_SIDED|99.0|0.02|0.74|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.74|0.02|<0.01
91521634|NCT03701399|182917932|SUPERIORITY||Least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.28||0.045|TWO_SIDED|95.0|-1.11|-0.01|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country.|SCA3 genotype participants||-0.01|-1.11|0.0450
91521635|NCT03945292|182917957|SUPERIORITY||Difference|-66.81|STANDARD_ERROR_OF_MEAN|5.107|<|0.0001|TWO_SIDED|95.0|-77.18|-56.45||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|Mixed model repeated measures (MMRM)|NAFLD=non-alcoholic fatty liver disease; NSH=non-alcoholic steatohepatitis||||-56.45|-77.18|< 0.0001
91521636|NCT03945292|182917957|SUPERIORITY||Difference|-90.03|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-100.72|-79.34||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-79.34|-100.72|< 0.0001
91782698|NCT00298558|183444599|SUPERIORITY_OR_OTHER||Effect Size|0.36|||<|0.01|TWO_SIDED|99.0|0.01|0.72|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.72|0.01|<0.01
91782699|NCT00298558|183444600|SUPERIORITY_OR_OTHER||Effect Size|0.004||||0.97|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.97
91521637|NCT03945292|182917957|SUPERIORITY||Difference|-97.57|STANDARD_ERROR_OF_MEAN|5.24|<|0.0001|TWO_SIDED|95.0|-108.21|-86.94||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-86.94|-108.21|< 0.0001
91521638|NCT03945292|182917961|SUPERIORITY||Least Squares (LS) Mean Difference|-129.31|STANDARD_ERROR_OF_MEAN|36.409||0.0021|TWO_SIDED|95.0|-205.52|-53.11||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-53.11|-205.52|0.0021
91521639|NCT03945292|182917961|SUPERIORITY||LS Mean Difference|-124.03|STANDARD_ERROR_OF_MEAN|37.207||0.0035|TWO_SIDED|95.0|-201.9|-46.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-46.15|-201.9|0.0035
91521640|NCT03945292|182917961|SUPERIORITY||LS Mean Difference|-140.58|STANDARD_ERROR_OF_MEAN|30.906||0.0002|TWO_SIDED|95.0|-205.27|-75.89||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-75.89|-205.27|0.0002
91593176|NCT02603120|183077344|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|-1.4|||||TWO_SIDED|95.002|-5.5|2.6|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.6|-5.5|
91593177|NCT02603120|183077344|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||.59
91593178|NCT02603120|183077345|OTHER||Difference in least squares means|-35.0||||0.031|TWO_SIDED|95.0|-67.0|-3.0|||ANOVA|||||-3|-67|0.031
91593179|NCT02603120|183077347|OTHER||Difference in least squares means|0.276||||0.33|TWO_SIDED|95.0|-0.275|0.827|||ANOVA|||||0.827|-0.275|0.33
91593180|NCT02603120|183077349|OTHER||Difference in least squares means|-0.143||||0.47|TWO_SIDED|95.0|-0.534|0.248|||ANOVA|||||0.248|-0.534|0.47
91593181|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.0034
91521641|NCT03945292|182917963|SUPERIORITY||LS Mean Difference|-98.07|STANDARD_ERROR_OF_MEAN|20.291||0.0001|TWO_SIDED|95.0|-140.53|-55.6||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-55.6|-140.53|0.0001
91782700|NCT00298558|183444600|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.86|TWO_SIDED|99.0|-0.25|0.22|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.22|-0.25|0.86
91593182|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.26||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.2600
91593183|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated measures Analysis of Variance|||60 minutes after study drug injection.||||0.0001
91593184|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.0039||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0039
91593185|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.93||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.9300
91593186|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.0031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0031
91593187|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.019||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0190
91593188|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.92||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.9200
91593189|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.015||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0150
91521642|NCT03945292|182917963|SUPERIORITY||LS Mean Difference|-109.56|STANDARD_ERROR_OF_MEAN|21.616|<|0.0001|TWO_SIDED|95.0|-154.81|-64.32||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-64.32|-154.81|< 0.0001
91593190|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0950
91593191|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.6||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.6000
91593192|NCT00916357|183077356|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0310
91593193|NCT00916357|183077357|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
91593194|NCT00916357|183077357|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.1800
91593195|NCT00916357|183077357|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
91782701|NCT00298558|183444600|SUPERIORITY_OR_OTHER||Effect Size|0.008||||0.93|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.93
91782702|NCT00298558|183444601|SUPERIORITY_OR_OTHER||Effect Size|0.02||||0.78|TWO_SIDED|99.0|-0.19|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.19|0.78
91782703|NCT00298558|183444601|SUPERIORITY_OR_OTHER||Effect Size|-0.004||||0.96|TWO_SIDED|99.0|-0.21|0.21|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.21|-0.21|0.96
91790307|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.682||0.066|TWO_SIDED|95.0|-2.602|0.081||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.081|-2.602|0.066
91790308|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|5.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790309|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.7||0.962|TWO_SIDED|95.0|-1.343|1.41||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.410|-1.343|0.962
91790310|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|5.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790311|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.887||0.265|TWO_SIDED|95.0|-2.734|0.755||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.755|-2.734|0.265
91790312|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91593196|NCT00916357|183077358|SUPERIORITY_OR_OTHER|||||||0.0045||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0045
91593197|NCT00916357|183077358|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.4800
91593198|NCT00916357|183077358|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0006
91790313|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.863||0.212|TWO_SIDED|95.0|-2.775|0.618||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.618|-2.775|0.212
91790314|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.29|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790315|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.893||0.602|TWO_SIDED|95.0|-2.223|1.29||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.290|-2.223|0.602
91521643|NCT03945292|182917963|SUPERIORITY||LS Mean Difference|-118.04|STANDARD_ERROR_OF_MEAN|17.16|<|0.0001|TWO_SIDED|95.0|-153.95|-82.12||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-82.12|-153.95|< 0.0001
91593199|NCT00916357|183077359|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
91593200|NCT00916357|183077359|SUPERIORITY_OR_OTHER|||||||0.0016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0016
91593201|NCT00916357|183077359|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.1000
91593202|NCT00916357|183077360|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone + Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
91593203|NCT00916357|183077360|SUPERIORITY_OR_OTHER|||||||0.3||||||Treatment comparison for Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.3000
91593204|NCT00916357|183077360|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
91593205|NCT00916357|183077361|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
91593206|NCT00916357|183077361|SUPERIORITY_OR_OTHER|||||||0.77||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.7700
91593207|NCT00916357|183077361|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
91593208|NCT00916357|183077362|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0100
91593209|NCT00916357|183077362|SUPERIORITY_OR_OTHER|||||||0.82||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8200
91593210|NCT00916357|183077362|SUPERIORITY_OR_OTHER|||||||0.0056||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0056
91593211|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.064||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.064
91593212|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.47||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.47
91790316|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|6.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91593213|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.012
91593214|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.099||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.099
91593215|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.46
91593216|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.02||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.020
91593217|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.13||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.13
91593218|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.41||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.41
91593219|NCT00916357|183077363|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.46
91593220|NCT00916357|183077364|SUPERIORITY_OR_OTHER|||||||0.016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.016
91790317|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.019||0.635|TWO_SIDED|95.0|-2.489|1.519||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.519|-2.489|0.635
91790318|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|6.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790319|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.003||0.795|TWO_SIDED|95.0|-2.233|1.712||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.712|-2.233|0.795
91790320|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790321|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|1.11|STANDARD_ERROR_OF_MEAN|1.027||0.281|TWO_SIDED|95.0|-0.91|3.128||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.128|-0.910|0.281
91790322|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91521644|NCT03945292|182917965|SUPERIORITY||LS Mean Difference|-180.7|STANDARD_ERROR_OF_MEAN|74.087||0.0247|TWO_SIDED|95.0|-335.77|-25.64||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-25.64|-335.77|0.0247
91521645|NCT03945292|182917965|SUPERIORITY||LS Mean Difference|-163.79|STANDARD_ERROR_OF_MEAN|73.513||0.0382|TWO_SIDED|95.0|-317.65|-9.93||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-9.93|-317.65|0.0382
91521646|NCT03945292|182917965|SUPERIORITY||LS Mean Difference|-193.2|STANDARD_ERROR_OF_MEAN|63.089||0.0064|TWO_SIDED|95.0|-325.25|-61.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-61.15|-325.25|0.0064
91521647|NCT06060457|182918022|OTHER||Geometric Mean Ratio (GMR)|0.625|||||TWO_SIDED|95.0|0.57|0.686||||||RSV-A: Arm 1 versus Arm 2||0.686|0.570|
91521648|NCT06060457|182918022|OTHER||GMR|0.638|||||TWO_SIDED|95.0|0.584|0.697||||||RSV-B: Arm 1 versus Arm 2||0.697|0.584|
91521649|NCT00514735|182918098|SUPERIORITY_OR_OTHER||||||<|0.0001||||||In order to maintain the overall level of significance at the α=0.025 level after a planned interim analysis using α=0.003, this test will actually be performed using an adjusted α=0.0245 at the completion of the study.|Chi-squared|||"H0: Pa ≤ Pm Ha: Pa \> Pm~where Pa is the proportion of successfully treated subjects in the ablation management arm and Pm is the proportion of successfully treated subjects in the optimal medical management/drug therapy arm."||||<0.0001
91521650|NCT00514735|182918099|SUPERIORITY_OR_OTHER|||||||0.1427||||||An exact, one-sample binomial test was conducted at a one-sided α=0.025 level of significance.|Fisher Exact|||"H0: Pa ≥ 0.16 Ha: Pa \< 0.16~where Pa is the proportion of acute safety failures in the ablation management arm."||||0.1427
91521651|NCT00514735|182918100|NON_INFERIORITY_OR_EQUIVALENCE|This objective was not statistically powered. The non-inferiority chronic safety margin was 0.06.||||||0.0033|||||||t-test, 1 sided|||"H0: Pa ≥ Pm + 0.06 Ha: Pa \< Pm + 0.06~where Pa is the proportion of failed subjects in the ablation management arm and Pm is the proportion of failed subjects in the optimal medical management/drug therapy arm."||||0.0033
91521652|NCT00514735|182918102|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LAD from baseline to 6 month in Ablation Management arm, and μm is the change of LAD from baseline to 6 month in Medical Management arm."||||0.35
91521653|NCT00514735|182918103|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LVEF from baseline to 6 month in Ablation Management arm, and μm is the change of LVEF from baseline to 6 month in Medical Management arm."||||0.06
91521654|NCT00514735|182918104|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91521655|NCT00514735|182918105|SUPERIORITY_OR_OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
91593221|NCT00916357|183077364|SUPERIORITY_OR_OTHER|||||||0.88||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8800
91593222|NCT00916357|183077364|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.011
91593223|NCT00916357|183077366|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
91593224|NCT00916357|183077366|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||0.1800
91593225|NCT00916357|183077366|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
91593226|NCT00916357|183077366|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison for Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
91593227|NCT00916357|183077366|SUPERIORITY_OR_OTHER|||||||0.72||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||0.7200
91648513|NCT01244815|183189703|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.33||||0.006|TWO_SIDED|95.0|-0.56|-0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.10|-0.56|0.006
91648514|NCT01244815|183189703|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.35||||0.003|TWO_SIDED|95.0|-0.59|-0.12|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.12|-0.59|0.003
91648515|NCT01244815|183189703|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.67|-0.21|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.21|-0.67|<0.001
91648516|NCT01244815|183189704|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.011|TWO_SIDED|95.0|-0.61|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.61|0.011
91648517|NCT01244815|183189704|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.63|||<|0.001|TWO_SIDED|95.0|-0.89|-0.36|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.36|-0.89|<0.001
91648518|NCT01244815|183189704|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.35|-0.88|<0.001
91648519|NCT01244815|183189705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.32|-0.90|<0.001
91648520|NCT01244815|183189705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.75|||<|0.001|TWO_SIDED|95.0|-1.04|-0.46|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.46|-1.04|<0.001
91648521|NCT01244815|183189705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.45|-1.03|<0.001
91648522|NCT01244815|183189706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.536|TWO_SIDED|95.0|-0.28|0.15|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.15|-0.28|0.536
91648523|NCT01244815|183189706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.811|TWO_SIDED|95.0|-0.24|0.19|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.19|-0.24|0.811
91648524|NCT01244815|183189706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.556|TWO_SIDED|95.0|-0.15|0.28|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.28|-0.15|0.556
91648525|NCT01244815|183189707|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.053|TWO_SIDED|95.0|-0.42|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.00|-0.42|0.053
91648526|NCT01244815|183189707|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.18||||0.094|TWO_SIDED|95.0|-0.4|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.40|0.094
91709204|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|1.13||||0.602|TWO_SIDED|95.0|0.71|1.81|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.81|0.71|0.602
91648527|NCT01244815|183189707|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15||||0.178|TWO_SIDED|95.0|-0.36|0.07|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.07|-0.36|0.178
91648528|NCT01244815|183189708|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.506|TWO_SIDED|95.0|-0.33|0.16|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.16|-0.33|0.506
91648529|NCT01244815|183189708|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19||||0.131|TWO_SIDED|95.0|-0.43|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.43|0.131
91648530|NCT01244815|183189708|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16||||0.211|TWO_SIDED|95.0|-0.4|0.09|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.09|-0.40|0.211
91648531|NCT01244815|183189709|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23||||0.079|TWO_SIDED|95.0|-0.49|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.49|0.079
91648532|NCT01244815|183189709|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.01|TWO_SIDED|95.0|-0.6|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.60|0.010
91709205|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.703|TWO_SIDED|95.0|0.55|1.5|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.50|0.55|0.703
91521656|NCT01499082|182918120|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.112|0.107||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.107|-0.112|
91521657|NCT01499082|182918121|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.79||||0.0045|TWO_SIDED|95.0|0.67|0.93|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.93|0.67|0.0045
91521658|NCT01499082|182918122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.162||0.6909|TWO_SIDED|95.0|-0.383|0.254|||ANCOVA|||Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.||0.254|-0.383|0.6909
91521659|NCT01499082|182918131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|-0.189|0.298||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.||0.298|-0.189|
91521660|NCT04557930|182918139|SUPERIORITY||Odds Ratio (OR)|0.96||||0.41|TWO_SIDED|95.0|0.88|1.06|||Mixed Models Analysis|||We tested the association between exposure to the intervention and the incidence of ACP billing in the pre- and post-intervention periods using a mixed effects logistic regression model, adjusting for time, patient and hospital covariates.||1.06|0.88|0.41
91521661|NCT04557930|182918139|SUPERIORITY|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Odds Ratio (OR)|1.03||||0.74|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|Overall effect allowing effect heterogeneity across steps \<0.001 Interaction effect \<0.001|Step 1 cohort|||1.19|0.89|0.74
91521662|NCT04557930|182918139|SUPERIORITY||Odds Ratio (OR)|1.15||||0.09|TWO_SIDED|95.0|0.98|1.36|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 2 cohort|1.36|0.98|0.09
91521663|NCT04557930|182918139|SUPERIORITY||Odds Ratio (OR)|1.13||||0.11|TWO_SIDED|95.0|0.97|1.33|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 3 cohort|1.33|0.97|0.11
91521664|NCT04557930|182918139|SUPERIORITY||Odds Ratio (OR)|0.66|||<|0.001|TWO_SIDED|95.0|0.57|0.76|||Mixed Models Analysis||Step 4 cohort|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.||0.76|0.57|<0.001
91521665|NCT04557930|182918139|SUPERIORITY||Odds Ratio (OR)|0.95||||0.49|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 5 cohort|1.19|0.89|0.49
91521666|NCT00803452|182918147|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
91521667|NCT01971723|182918169|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|Groups were compared against each other at the two different time points and against themselves at the same time points.||This statistical analysis is for the squat one repetition maximum outcomes, only.||||.38
91521668|NCT01971723|182918169|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis is for the bench press one repetition maximum outcomes, only.||||0.0001
91521669|NCT01971723|182918169|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||This statistical analysis is for the deadlift one repetition maximum measures, only.||||.3
91521670|NCT01971723|182918169|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis compares the outcomes of the total weight lifted.||||0.0001
91521671|NCT01971723|182918170|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91521672|NCT01971723|182918171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical measurement is for cholesterol measure outcomes, only.||||>.05
91790323|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261||0.729|TWO_SIDED|95.0|-2.918|2.043||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.043|-2.918|0.729
91521673|NCT01971723|182918171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for glucose measure outcomes, only.||||>.05
91521674|NCT01971723|182918171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for HDL measure outcomes, only.||||>.05
91521675|NCT01971723|182918171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for LDL measure outcomes, only.||||>.05
91790324|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|7.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790325|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|1.248||0.636|TWO_SIDED|95.0|-3.047|1.863||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.863|-3.047|0.636
91593228|NCT00916357|183077366|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
91593229|NCT04451161|183077411|SUPERIORITY|||||||0.591||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.591
91648533|NCT01244815|183189709|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.139|TWO_SIDED|95.0|-0.46|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.46|0.139
91648534|NCT01244815|183189710|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.61||||0.004|TWO_SIDED|95.0|-4.38|-0.83|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.83|-4.38|0.004
91648535|NCT01244815|183189710|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.17||||0.017|TWO_SIDED|95.0|-3.95|-0.39|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.39|-3.95|0.017
91648536|NCT01244815|183189710|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.16||||0.017|TWO_SIDED|95.0|-3.93|-0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.38|-3.93|0.017
91648537|NCT01244815|183189711|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.79||||0.395|TWO_SIDED|95.0|-2.62|1.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||1.04|-2.62|0.395
91648538|NCT01244815|183189711|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.44||||0.009|TWO_SIDED|95.0|-4.26|-0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.63|-4.26|0.009
91648539|NCT01244815|183189711|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.121|TWO_SIDED|95.0|-3.27|0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.38|-3.27|0.121
91648540|NCT01244815|183189712|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.135|TWO_SIDED|95.0|-3.33|0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.45|-3.33|0.135
91648541|NCT01244815|183189712|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.19||||0.023|TWO_SIDED|95.0|-4.08|-0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.30|-4.08|0.023
91648542|NCT01244815|183189712|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.28||||0.189|TWO_SIDED|95.0|-3.2|0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.63|-3.20|0.189
91648543|NCT01244815|183189713|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.29||||0.002|TWO_SIDED|95.0|1.56|7.02|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.02|1.56|0.002
91648544|NCT01244815|183189713|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.95|||<|0.001|TWO_SIDED|95.0|4.22|9.68|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||9.68|4.22|<0.001
91648545|NCT01244815|183189713|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.11|||<|0.001|TWO_SIDED|95.0|2.31|7.91|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.91|2.31|<0.001
91648546|NCT01244815|183189714|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.24||||0.05|TWO_SIDED|95.0|0.0|4.48|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||4.48|-0.00|0.050
91648547|NCT01244815|183189714|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.35||||0.239|TWO_SIDED|95.0|-0.9|3.59|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||3.59|-0.90|0.239
91648548|NCT01244815|183189714|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.78||||0.018|TWO_SIDED|95.0|0.48|5.08|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||5.08|0.48|0.018
91648549|NCT01244815|183189715|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.39||||0.001|TWO_SIDED|95.0|0.15|0.62|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.62|0.15|0.001
91648550|NCT01244815|183189715|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.18||||0.135|TWO_SIDED|95.0|-0.06|0.41|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.41|-0.06|0.135
91648551|NCT01244815|183189715|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.25||||0.044|TWO_SIDED|95.0|0.01|0.49|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.49|0.01|0.044
91648552|NCT00919802|183189784|OTHER|||||||0.688|||||||t-test, 2 sided|||Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.||||0.688
91648553|NCT00919802|183189785|OTHER|paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test||||||0.7252|||||||t-test, 2 sided|||||||0.7252
91648554|NCT02059187|183189812|NON_INFERIORITY_OR_EQUIVALENCE|MK-1293 was to be considered non-inferior to Lantus in type 2 diabetes mellitus (T2DM) if the upper bound of the two-sided 95% confidence interval (CI) for the between-treatment difference (MK-1293 minus Lantus) in least-squares (LS) means was below 0.4% based on a cLDA model.|Difference in least squares means|0.03|||||TWO_SIDED|95.0|-0.12|0.18||||||||0.18|-0.12|
91648555|NCT02059187|183189813|SUPERIORITY_OR_OTHER||Difference in percentage|5.7|||||TWO_SIDED|95.0|-2.3|13.7||||||||13.7|-2.3|
91648556|NCT02059187|183189815|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-8.5|8.5||||||||8.5|-8.5|
91648557|NCT02059187|183189816|SUPERIORITY_OR_OTHER||Difference in percent|6.8|||||TWO_SIDED|95.0|-0.6|14.2||||||||14.2|-0.6|
91648558|NCT02059187|183189817|SUPERIORITY_OR_OTHER||Difference in LS means|1.4|||||TWO_SIDED|95.0|-2.2|4.9||||||||4.9|-2.2|
91648559|NCT02059187|183189818|SUPERIORITY_OR_OTHER||Dofference in LS means|0.01|||||TWO_SIDED|95.0|-0.02|0.05||||||||0.05|-0.02|
91648560|NCT02059187|183189819|SUPERIORITY_OR_OTHER||Difference in LS means|3.5|||||TWO_SIDED|95.0|-3.7|10.7||||||||10.7|-3.7|
91648561|NCT02059187|183189820|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4|||||TWO_SIDED|95.0|-11.3|4.4||||||||4.4|-11.3|
91648562|NCT02059187|183189821|SUPERIORITY_OR_OTHER||Adjusted difference in percent|2.8|||||TWO_SIDED|95.0|-6.1|11.6|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||11.6|-6.1|
91648563|NCT02059187|183189822|SUPERIORITY_OR_OTHER||Adjusted difference in percent|-0.9|||||TWO_SIDED|95.0|-8.3|6.5|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||6.5|-8.3|
91648564|NCT03751020|183189823|SUPERIORITY||Mean Difference (Net)|-6.34|||<|0.01|TWO_SIDED|95.0|-11.03|-1.64|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-1.64|-11.03|<0.01
91648565|NCT03751020|183189824|SUPERIORITY||Mean Difference (Net)|-0.33||||0.03|TWO_SIDED|95.0|-0.62|-0.03|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-0.03|-0.62|0.03
91648566|NCT03751020|183189825|SUPERIORITY||Mean Difference (Net)|-4.03||||0.07|TWO_SIDED|95.0|-8.55|0.47|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.47|-8.55|0.07
91648567|NCT03751020|183189826|SUPERIORITY||Mean Difference (Net)|1.12||||0.73|TWO_SIDED|95.0|-6.48|8.77|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||8.77|-6.48|0.73
91648568|NCT03751020|183189827|SUPERIORITY||Mean Difference (Net)|-1.28||||0.1|TWO_SIDED|95.0|-2.8|0.24|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.24|-2.80|0.10
91648569|NCT03751020|183189828|SUPERIORITY||Mean Difference (Net)|0.09||||0.76|TWO_SIDED|95.0|-1.19|1.57|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||1.57|-1.19|0.76
91648570|NCT00528879|183189853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1014||0.0002||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0002
91648571|NCT00528879|183189853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1016|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
91648572|NCT00528879|183189853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1021|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
91648573|NCT00528879|183189854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|3.774|<|0.0019||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0019
91648574|NCT00528879|183189854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|3.781|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91648575|NCT00528879|183189854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|3.819|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91648576|NCT00528879|183189855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91648577|NCT00528879|183189855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91648578|NCT00528879|183189855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3365|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91593230|NCT04451161|183077411|SUPERIORITY|||||||0.032||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.032
91593231|NCT04451161|183077411|SUPERIORITY|||||||0.054||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase.|Chi-squared|||One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.054
91593232|NCT04451161|183077411|SUPERIORITY|||||||0.98||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.98
91648579|NCT00528879|183189856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.1||||0.1775||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.1775
91648580|NCT00528879|183189856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.0275||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0275
91709206|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.455|TWO_SIDED|95.0|0.58|1.28|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.28|0.58|0.455
91648581|NCT00528879|183189856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7||||0.0062||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0062
91648582|NCT00528879|183189857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.3515||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
91709207|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.929|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.57|0.66|0.929
91593233|NCT04451161|183077411|SUPERIORITY|||||||0.068||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.068
91593234|NCT04451161|183077411|SUPERIORITY|||||||0.165||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.165
91648583|NCT00528879|183189857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3022||0.0068||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0068
91593235|NCT04451161|183077411|SUPERIORITY|||||||0.191||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.191
91648584|NCT00528879|183189857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.3535||0.029||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0290
91648585|NCT00528879|183189858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3681||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
91593236|NCT04451161|183077411|SUPERIORITY|||||||0.86||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.86
91648586|NCT00528879|183189858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.3745|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91593237|NCT04451161|183077412|SUPERIORITY||Slope|3.425|STANDARD_ERROR_OF_MEAN|2.783||0.22|TWO_SIDED|95.0|-2.064|8.915||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||8.915|-2.064|0.22
91593238|NCT04451161|183077412|SUPERIORITY||Slope|4.97|STANDARD_ERROR_OF_MEAN|2.774||0.075|TWO_SIDED|95.0|-0.502|10.443||Mixed model analysis was used (the students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||10.443|-.502|0.075
91593239|NCT04451161|183077413|SUPERIORITY||Slope|1.024|STANDARD_ERROR_OF_MEAN|0.952||0.284|TWO_SIDED|95.0|-0.855|2.904||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||2.904|-.855|0.284
91648587|NCT00528879|183189858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3791|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91648588|NCT00528879|183189865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1109||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
91782704|NCT00298558|183444601|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.56|TWO_SIDED|99.0|-0.26|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.26|0.56
91782705|NCT02581410|183444602|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17|||ANCOVA|||To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).||1.17|0.92|
91782706|NCT01322945|183444650|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
91593240|NCT04451161|183077413|SUPERIORITY||Slope|1.908|STANDARD_ERROR_OF_MEAN|0.951||0.046|TWO_SIDED|95.0|0.03|3.786||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||3.786|.03|.046
91648589|NCT00528879|183189865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1129||0.0004||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0004
91521676|NCT01971723|182918171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis for the triglyceride measure outcomes, only.||||>.05
91648590|NCT00528879|183189865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1146|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91782707|NCT02819011|183444707|SUPERIORITY|||||||0.04||||||priori threshold for statistical significance= 0.05|Mixed Models Analysis|||Repeated measures to compare changes in two groups from baseline to 6 months||||0.040
91782708|NCT02819011|183444708|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.005
91782709|NCT02819011|183444709|SUPERIORITY|||||||0.019||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.019
91782710|NCT02819011|183444711|SUPERIORITY|||||||0.572||||||priori threshold for statistical significance = 0.05|Generalized Estimating Equations|||Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.||||0.572
91782711|NCT02819011|183444712|SUPERIORITY|||||||0.65||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.650
91782712|NCT02819011|183444713|SUPERIORITY|||||||0.756||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.756
91593241|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.1|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.146|0.100|<0.0001
91593242|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.117|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.094|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.140|0.094|<0.0001
91593243|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.086|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.132|0.086|<0.0001
91648591|NCT00528879|183189866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|2.769||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
91593244|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.07|0.116||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.116|0.070|<0.0001
91593245|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.08|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.080|<0.0001
91593246|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2169|TWO_SIDED|95.0|-0.008|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.037|-0.008|0.2169
91593247|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.13||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.130|0.085|<0.0001
91782713|NCT02819011|183444716|SUPERIORITY|||||||0.769||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.769
91782714|NCT02819011|183444717|SUPERIORITY|||||||0.857||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.857
91782715|NCT02819011|183444718|SUPERIORITY|||||||0.829||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.829
91782716|NCT02260180|183444787|SUPERIORITY|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91782717|NCT02260180|183444787|SUPERIORITY||||||<|0.0001|||||||Chi-squared|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.||||||<0.0001
91782718|NCT02260180|183444788|SUPERIORITY||||||<|0.0001||||||No adjustment for multiple comparisons were made.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||||||<0.0001
91782719|NCT02260180|183444788|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons were conducted.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.||||<0.0001
91782720|NCT00943072|183444791|SUPERIORITY_OR_OTHER||Risk Difference (RD)|44.8|||<|0.0001|TWO_SIDED|95.0|33.0|56.6||P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA \> 20/200 and BCVA ≤ 20/200)|Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||56.6|33.0|< 0.0001
91782721|NCT00943072|183444792|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|17.36|26.04|||ANCOVA||RD is the IAI group minus sham group. 95% confidence interval is for the RD.|||26.04|17.36|< 0.0001
91782722|NCT00943072|183444792|SUPERIORITY_OR_OTHER||Least Square Mean|16.36|||||||||||ANCOVA||LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
91782723|NCT00943072|183444793|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-311.9|||<|0.0001|TWO_SIDED|95.0|-389.4|-234.4|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-234.4|-389.4|< 0.0001
91782724|NCT00943072|183444793|SUPERIORITY_OR_OTHER||Least Square Mean|-487.1|||||||||||ANCOVA||The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
91782725|NCT00943072|183444794|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.6||||0.0059|TWO_SIDED|95.0|-12.2|-1.1|||Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-1.1|-12.2|0.0059
91782726|NCT00943072|183444795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.26||||0.0009|TWO_SIDED|95.0|2.61|9.91|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||9.91|2.61|0.0009
91782727|NCT00943072|183444795|SUPERIORITY_OR_OTHER||Least Square Mean|8.8|||||||||||ANCOVA||Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
91782728|NCT01193257|183444796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.12085|TWO_SIDED|95.0|0.739|1.036|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\[less than or equal to\] \<=4, greater than \[\>\] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||1.036|0.739|0.12085
91593248|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.012||0.5849|TWO_SIDED|95.0|-0.017|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.017|0.5849
91593249|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1863|TWO_SIDED|95.0|-0.007|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.007|0.1863
91593250|NCT01431274|183077451|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4352|TWO_SIDED|95.0|-0.032|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.014|-0.032|0.4352
91593251|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.106||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.106|0.059|<.0001
91593252|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.047|<0.0001
91593253|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.081|0.034|<0.0001
91593254|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0174|TWO_SIDED|95.0|0.005|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.052|0.005|0.0174
91593255|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
91593256|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0407|TWO_SIDED|95.0|0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|0.001|0.0407
91593257|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.03|0.077||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.077|0.030|<0.0001
91648592|NCT00528879|183189866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.762|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91593258|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3326|TWO_SIDED|95.0|-0.012|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.012|0.3326
91593259|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0151|TWO_SIDED|95.0|0.006|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.006|0.0151
91648593|NCT00528879|183189866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.808|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
91648594|NCT00528879|183189867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|Modified logistic regression|||||||
91648595|NCT00528879|183189867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.8627|||||||Modified logistic regression|||||||0.8627
91648596|NCT00528879|183189867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.0149||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0149
91648597|NCT02555618|183189870|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.7|||||TWO_SIDED|95.0|-7.983|11.415|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||11.415|-7.983|
91648598|NCT02555618|183189870|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-4.8|||||TWO_SIDED|95.0|-13.974|4.403|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||4.403|-13.974|
91648599|NCT02555618|183189870|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|2.6|||||TWO_SIDED|95.0|-6.082|11.32|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||11.320|-6.082|
91593260|NCT01431274|183077452|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1421|TWO_SIDED|95.0|-0.041|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.006|-0.041|0.1421
91593261|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.608|-2.778|0.0022
91648600|NCT02555618|183189871|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.7984|1.2253|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2253|0.7984|
91648601|NCT02555618|183189871|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.5544|1.05|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0500|0.5544|
91782729|NCT01193257|183444797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.00038|TWO_SIDED|95.0|0.653|0.885|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\<=4, \>4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||0.885|0.653|0.00038
91648602|NCT02555618|183189871|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.8134|1.3931|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3931|0.8134|
91648603|NCT02555618|183189874|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|6.8|||||TWO_SIDED|95.0|-3.02|16.348||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||16.348|-3.020|
91648604|NCT02555618|183189874|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-8.8|||||TWO_SIDED|95.0|-18.282|0.901||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||0.901|-18.282|
91648605|NCT02555618|183189874|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.3|||||TWO_SIDED|95.0|-11.461|6.835||||||The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||6.835|-11.461|
91648606|NCT02555618|183189875|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9559|1.1473|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.1473|0.9559|
91648607|NCT02555618|183189875|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.7862|1.0241|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0241|0.7862|
91648608|NCT02555618|183189875|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.9273|1.0364|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.0364|0.9273|
91648609|NCT02555618|183189878|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|14.7|||||TWO_SIDED|95.0|5.489|23.577||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||23.577|5.489|
91648610|NCT02555618|183189878|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-1.9|||||TWO_SIDED|95.0|-10.614|6.928||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||6.928|-10.614|
91648611|NCT02555618|183189878|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.4|||||TWO_SIDED|95.0|-10.346|5.579||||||The analysis is difference of seroconversion rate between treatment groups for B-Strain.||5.579|-10.346|
91648612|NCT02555618|183189879|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.1221|1.9623|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.9623|1.1221|
91648613|NCT02555618|183189879|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.7806|1.4564|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.4564|0.7806|
91782730|NCT01193257|183444798|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||< 0.0001
91782731|NCT01193257|183444799|SUPERIORITY_OR_OTHER|||||||0.12778|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||0.12778
91593262|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.153|-2.313|0.0252
91593263|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.052|-2.113|0.0620
91521677|NCT01971723|182918172|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91593264|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.618|-1.531|0.4051
91648614|NCT02555618|183189879|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.8166|1.3934|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3934|0.8166|
91648615|NCT02555618|183189882|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.1|||||TWO_SIDED|95.0|-7.195|9.423|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||9.423|-7.195|
91648616|NCT02555618|183189882|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-0.8|||||TWO_SIDED|95.0|-10.369|8.803|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||8.803|-10.369|
91593265|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.507|-1.649|0.2988
91709208|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.507|TWO_SIDED|95.0|0.63|2.51|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||2.51|0.63|0.507
91613942|NCT01505491|183121768|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|109.42|STANDARD_ERROR_OF_MEAN|1.073||0.0303|TWO_SIDED|90.0|97.384|122.935|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.935|97.384|0.0303
91782732|NCT00839319|183444821|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Correlations between serum hormone levels and IT hormones, and between IT hormones were performed on 23 subjects in 4 groups using Spearmen technique.||||||<0.05
91521678|NCT01971723|182918173|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91521679|NCT01971723|182918174|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91521680|NCT01971723|182918175|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91782733|NCT00373113|183444899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.002|TWO_SIDED|95.0|1.156|1.869||2-sided log-rank test with the same set of stratification factors. The set of stratification factors included those used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|Null hypothesis is that PFS (median=4.2 months) for sunitinib arm equals PFS for capecitabine arm. The study was designed to have 90% power to detect statistical difference in PFS between two treatment groups assuming the hazard ratio (sunitinib/capecitabine) is 0.75 and both arms follow exponential distribution.||1.869|1.156|0.002
91782734|NCT00373113|183444900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.516|||<|0.001|TWO_SIDED|95.0|1.188|1.933||2-sided log-rank test with the same set of stratification factors that was used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|||1.933|1.188|<0.001
91782735|NCT00373113|183444901|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|11.3|||||TWO_SIDED|95.0|7.6|16.1||||||||16.1|7.6|
91782736|NCT00373113|183444901|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|16.4|||||TWO_SIDED|95.0|12.0|21.6||||||||21.6|12.0|
91782737|NCT00373113|183444901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.049||||0.109|TWO_SIDED|95.0|-11.2|1.1|||Pearson Chi-Square Test|||||1.1|-11.2|0.109
91782738|NCT00373113|183444902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.788||||0.037|TWO_SIDED|95.0|1.042|7.459|||Log Rank|||||7.459|1.042|0.037
91782739|NCT00373113|183444904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.219|TWO_SIDED|95.0|0.896|1.611||2-sided log-rank test with the same set of stratification factors that were used in the randomization except study sites.|Log Rank|||||1.611|0.896|0.219
91782740|NCT00539942|183444920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.05|||||||Chi-squared|||Unable to analyze data||||<.05
91782741|NCT02362282|183444974|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
91782742|NCT02004093|183444976|SUPERIORITY_OR_OTHER|||||||0.3967|||||||Log Rank|||||||0.3967
91782743|NCT02004093|183444976|SUPERIORITY_OR_OTHER|||||||0.4552|||||||Wilcoxon (Mann-Whitney)|||||||0.4552
91782744|NCT02004093|183444976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.3972|TWO_SIDED|80.0|0.92|1.49||p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1|Wald test|||||1.49|0.92|0.3972
91782745|NCT02004093|183444977|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.32||||0.3943|TWO_SIDED|80.0|-3.9|16.6|||Chi-squared|||||16.6|-3.9|0.3943
91782746|NCT02004093|183444977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|80.0|0.86|2.17|||||approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method|||2.17|0.86|
91782747|NCT02004093|183444978|SUPERIORITY_OR_OTHER|||||||0.3655|||||||Log Rank|||||||0.3655
91782748|NCT02004093|183444978|SUPERIORITY_OR_OTHER|||||||0.1319|||||||Wilcoxon (Mann-Whitney)|||||||0.1319
91782749|NCT02004093|183444978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.3679|TWO_SIDED|80.0|0.92|1.61|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.61|0.92|0.3679
91782750|NCT02004093|183444981|SUPERIORITY_OR_OTHER|||||||0.8129|||||||Log Rank|||||||0.8129
91782751|NCT02004093|183444981|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.6920
91782752|NCT02004093|183444981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8137|TWO_SIDED|80.0|0.82|1.32|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.32|0.82|0.8137
91782753|NCT02004093|183444984|SUPERIORITY_OR_OTHER|||||||0.5726|||||||Log Rank|||||||0.5726
91782754|NCT02004093|183444984|SUPERIORITY_OR_OTHER|||||||0.3903|||||||Wilcoxon (Mann-Whitney)|||||||0.3903
91782755|NCT02004093|183444984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.587|TWO_SIDED|80.0|0.87|1.43|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.43|0.87|0.5870
91782756|NCT02004093|183444986|SUPERIORITY_OR_OTHER|||||||0.9261|||||||Log Rank|||||||0.9261
91782757|NCT02004093|183444986|SUPERIORITY_OR_OTHER|||||||0.8591|||||||Wilcoxon (Mann-Whitney)|||||||0.8591
91782758|NCT02004093|183444986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9262|TWO_SIDED|80.0|0.74|1.41||p-value resulting from Wald test of null hypothesis that the hazard ratio=1|Wald test|||||1.41|0.74|0.9262
91782759|NCT00439517|183444990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0048|TWO_SIDED|95.0|0.515|0.889|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.889|0.515|0.0048
91521681|NCT01971723|182918176|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91521682|NCT01971723|182918177|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>.05
91593266|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.407|-1.731|0.2249
91593267|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.042|-2.195|0.0418
91593268|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.633|-1.552|0.4097
91593269|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.515|-1.664|0.3013
91593270|NCT01431274|183077453|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||1.200|-0.970|0.8355
91593271|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.684|0.155|0.0019
91593272|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.619|0.092|0.0082
91593273|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.681|0.152|0.0020
91593274|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.554|0.027|0.0307
91593275|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.616|0.089|0.0088
91593276|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.266|-0.259|0.9801
91593277|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.557|0.030|0.0289
91593278|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.330|-0.202|0.6382
91593279|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.391|-0.140|0.3525
91593280|NCT01431274|183077454|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.203|-0.327|0.6457
91593281|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0067|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0067
91648617|NCT02555618|183189882|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|3.2|||||TWO_SIDED|95.0|-6.406|12.757|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||12.757|-6.406|
91521683|NCT01971723|182918178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for deadlift volume measure outcomes, only.||||>.05
91648618|NCT02555618|183189883|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.9106|1.2484|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2484|0.9106|
91648619|NCT02555618|183189883|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.8686|1.0969|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.||1.0969|0.8686|
91648620|NCT02555618|183189883|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9622|1.1427|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.1427|0.9622|
91648621|NCT00845026|183189891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0||||No adjustments were made for multiplicity. All treatment comparisons were evaluated based on a two-sided significance level of 0.05.|Log Rank|||||||0.184
91648622|NCT02522949|183189962|SUPERIORITY|||||||0.7146|||||||ANCOVA|||Oropharyngeal||||0.7146
91648623|NCT02522949|183189962|SUPERIORITY|||||||0.3543|||||||ANCOVA|||Nasal||||0.3543
91648624|NCT02522949|183189970|OTHER|||||||0.0232|||||||Exact Wilcoxon rank sum test|||||||0.0232
91648625|NCT00725725|183189982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5299||||0.3934|TWO_SIDED|95.0|-2.0781|5.138|||Mixed Models Analysis|||||5.1380|-2.0781|0.3934
91648626|NCT00725725|183189982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2667||||0.3515|TWO_SIDED|95.0|-1.4665|4.0|||Mixed Models Analysis|||||4.0000|-1.4665|0.3515
91648627|NCT00725725|183189983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8246||||0.3597|TWO_SIDED|95.0|-5.8307|2.1815|||Mixed Models Analysis|||||2.1815|-5.8307|0.3597
91648628|NCT00725725|183189983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4414||||0.777|TWO_SIDED|95.0|-3.5952|2.7124|||Mixed Models Analysis|||||2.7124|-3.5952|0.7770
91648629|NCT00725725|183189984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3356||||0.2683|TWO_SIDED|95.0|-1.8933|6.5644|||Mixed Models Analysis|||||6.5644|-1.8933|0.2683
91648630|NCT00725725|183189984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1317||||0.0844|TWO_SIDED|95.0|-0.4518|6.7152|||Mixed Models Analysis|||||6.7152|-0.4518|0.0844
91648631|NCT00725725|183189988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3456||||0.8894|TWO_SIDED|95.0|-4.6211|5.3124|||Mixed Models Analysis|||||5.3124|-4.6211|0.8894
91648632|NCT00725725|183189988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0417||||0.3765|TWO_SIDED|95.0|-2.5526|6.636|||Mixed Models Analysis|||||6.6360|-2.5526|0.3765
91648633|NCT00725725|183189989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2502||||0.8073|TWO_SIDED|95.0|-11.4963|8.9958|||Mixed Models Analysis|||||8.9958|-11.4963|0.8073
91648634|NCT00725725|183189989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0291||||0.661|TWO_SIDED|95.0|-7.2132|11.2714|||Mixed Models Analysis|||||11.2714|-7.2132|0.6610
91648635|NCT00725725|183189990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7296||||0.7895|TWO_SIDED|95.0|-4.7291|6.1883|||Mixed Models Analysis|||||6.1883|-4.7291|0.7895
91648636|NCT00725725|183189990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.526||||0.5488|TWO_SIDED|95.0|-3.5495|6.6015|||Mixed Models Analysis|||||6.6015|-3.5495|0.5488
91648637|NCT00725725|183189991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2766||||0.6516|TWO_SIDED|95.0|-6.9269|4.3738|||Mixed Models Analysis|||||4.3738|-6.9269|0.6516
91648638|NCT00725725|183189991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1867||||0.0256|TWO_SIDED|95.0|-11.5864|-0.7869|||Mixed Models Analysis|||||-0.7869|-11.5864|0.0256
91648639|NCT04288115|183190005|NON_INFERIORITY|An one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|-5.3||||0.0913|TWO_SIDED|90.0|-16.1|5.4||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Hypothyroid Symptoms score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||5.4|-16.1|0.0913
91593282|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
91593283|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.012||0.0746|TWO_SIDED|95.0|-0.002|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.002|0.0746
91593284|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.054|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.101|0.054|<0.0001
91593285|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.046|<0.0001
91593286|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3549|TWO_SIDED|95.0|-0.013|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.013|0.3549
91593287|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.065|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.113|0.065|<0.0001
91593288|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.072|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.072|<0.0001
91593289|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.08|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-0.080|<0.0001
91593290|NCT01431274|183077455|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.012||0.5018|TWO_SIDED|95.0|-0.016|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.016|0.5018
91593291|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.104|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.104|<0.0001
91593292|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.102|0.15||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.150|0.102|<0.0001
91593293|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.135|0.087|<0.0001
91648640|NCT04288115|183190005|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical difference.|Difference in Group Means|0.8||||0.8793|TWO_SIDED|95.0|-9.4|10.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates the real discontinuation mean and the sham discontinuation mean are different. Adjusted for gender and baseline HSSs.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-week outcome||10.9|-9.4|0.8793
91593294|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.096|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.072|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.072|<0.0001
91593295|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.133||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.133|0.085|<0.0001
91593296|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1569|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1569
91593297|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.089|0.137||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.137|0.089|<0.0001
91593298|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.012||0.8834|TWO_SIDED|95.0|-0.022|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.026|-0.022|0.8834
91593299|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.012||0.2129|TWO_SIDED|95.0|-0.009|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.009|0.2129
91593300|NCT01431274|183077456|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.012||0.2702|TWO_SIDED|95.0|-0.037|0.01||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.010|-0.037|0.2702
91593301|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.117|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.166|0.117|<0.0001
91593302|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.09|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.139|0.090|<0.0001
91593303|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.143||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.143|0.094|<0.0001
91593304|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.099|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.074|<0.0001
91593305|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.067|0.117||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.117|0.067|<0.0001
91593306|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.023|STANDARD_ERROR_OF_MEAN|0.013||0.0717|TWO_SIDED|95.0|-0.002|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.002|0.0717
91593307|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.097|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.097|<0.0001
91593308|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0344|TWO_SIDED|95.0|0.002|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.051|0.002|0.0344
91648641|NCT04288115|183190005|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-2.3||||0.686|TWO_SIDED|95.0|-14.0|9.3||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline HSS.|Differences are reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-month outcome||9.3|-14.0|0.6860
91648642|NCT04288115|183190006|NON_INFERIORITY|A one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|5.2||||0.0036|TWO_SIDED|90.0|-6.2|16.6||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Tiredness score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||16.6|-6.2|0.0036
91709209|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.805|TWO_SIDED|95.0|0.44|1.89|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||1.89|0.44|0.805
91593309|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.1126|TWO_SIDED|95.0|-0.005|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.005|0.1126
91593310|NCT01431274|183077457|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.6009|TWO_SIDED|95.0|-0.018|0.031||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.031|-0.018|0.6009
91593311|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.049|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.096|0.049|<0.0001
91593312|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.087|0.039|<0.0001
91593313|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
91593314|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0122|TWO_SIDED|95.0|0.007|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.054|0.007|0.0122
91648643|NCT04288115|183190006|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|2.3||||0.7104|TWO_SIDED|95.0|-10.1|14.7||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These mean differences have been adjusted for gender and baseline tiredness score.|Analysis of 6-week outcome||14.7|-10.1|0.7104
91648644|NCT04288115|183190006|OTHER|A two-sided α-level of 0.05 will be used to determine statistical significance.|Difference in Group Means|5.4||||0.3381|TWO_SIDED|95.0|-5.9|16.7||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline tiredness scores.|Analysis of 6-month outcome||16.7|-5.9|0.3381
91593315|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.012||0.0021|TWO_SIDED|95.0|0.014|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.061|0.014|0.0021
91593316|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0347|TWO_SIDED|95.0|0.002|0.049||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.049|0.002|0.0347
91593317|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.032|0.08||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.080|0.032|<0.0001
91593318|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4407|TWO_SIDED|95.0|-0.014|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.033|-0.014|0.4407
91593319|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1777|TWO_SIDED|95.0|-0.007|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.040|-0.007|0.1777
91593320|NCT01431274|183077458|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5641|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5641
91593321|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
91593322|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.051|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.099|0.051|<0.0001
91593323|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.012||0.0018|TWO_SIDED|95.0|0.014|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.062|0.014|0.0018
91593324|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0517|TWO_SIDED|95.0|0.0|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.000|0.0517
91593325|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0072|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0072
91593326|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0005|TWO_SIDED|95.0|0.019|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.066|0.019|0.0005
91593327|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.042|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|0.042|<0.0001
91593328|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.012||0.6619|TWO_SIDED|95.0|-0.018|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.018|0.6619
91648645|NCT04288115|183190007|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-0.02||||0.4684|TWO_SIDED|95.0|-0.076|0.036||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-week EQ-5D Descriptive score outcome.||0.036|-0.076|0.4684
91648646|NCT04288115|183190007|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|0.003||||0.9585|TWO_SIDED|95.0|-0.102|0.107||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-month EQ-5D Descriptive score outcome.||0.107|-0.102|0.9585
91593329|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2401|TWO_SIDED|95.0|-0.01|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.038|-0.010|0.2401
91593330|NCT01431274|183077459|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4601|TWO_SIDED|95.0|-0.033|0.015||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.015|-0.033|0.4601
91593331|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.064|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.112|0.064|<0.0001
91593332|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.052|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.052|<0.0001
91593333|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.046|<0.0001
91593334|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.027|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|0.027|<0.0001
91593335|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.082|0.034|<0.0001
91593336|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1405|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1405
91593337|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.045|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.045|<0.0001
91593338|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3118|TWO_SIDED|95.0|-0.012|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.036|-0.012|0.3118
91593339|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.012||0.1171|TWO_SIDED|95.0|-0.005|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.043|-0.005|0.1171
91593340|NCT01431274|183077460|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5759|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5759
91593341|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.079|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.055|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.103|0.055|<0.0001
91593342|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.038|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.086|0.038|<0.0001
91593343|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.037|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.085|0.037|<0.0001
91593344|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.071|0.022|0.0002
91593345|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.012||0.0004|TWO_SIDED|95.0|0.019|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.068|0.019|0.0004
91593346|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.136|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1360
91593347|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.041|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|0.041|<0.0001
91593348|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1617|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1617
91593349|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2476|TWO_SIDED|95.0|-0.01|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.010|0.2476
91593350|NCT01431274|183077461|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.012||0.8083|TWO_SIDED|95.0|-0.021|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.027|-0.021|0.8083
91648647|NCT04288115|183190007|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|7.0||||0.0643|TWO_SIDED|95.0|-0.4|14.4||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-week EQ-5D VAS score outcome.||14.4|-0.4|0.0643
91782760|NCT00439517|183444991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.756||||0.016|TWO_SIDED|95.0|1.11|2.777|||Cochran-Mantel-Haenszel|Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.||||2.777|1.110|0.016
91782761|NCT00439517|183444992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3797|TWO_SIDED|95.0|0.603|1.213|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.213|0.603|0.3797
91782762|NCT00439517|183444993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.8575|TWO_SIDED|95.0|0.755|1.263|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||1.263|0.755|0.8575
91782763|NCT02289157|183445019|OTHER||Risk Ratio (RR)|0.9||||0.54|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.||||1.4|0.5|0.54
91782764|NCT02289157|183445020|OTHER|||||||0.31|||||||Chi-squared|Pearson Chi-squared, df (3)||Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.||||0.31
91782765|NCT02289157|183445021|OTHER|||||||0.54||||||Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.|Wilcoxon (Mann-Whitney)|||||||0.54
91782766|NCT02289157|183445022|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.||||0.41
91593351|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.075|0.124||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.124|0.075|<0.0001
91782767|NCT02289157|183445023|OTHER|||||||0.38|||||||Chi-squared|||Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.||||0.38
91782768|NCT02289157|183445024|OTHER|||||||0.48||||||Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.|Chi-squared|||||||0.48
91782769|NCT02289157|183445025|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.||||0.52
91782770|NCT02289157|183445025|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.||||0.45
91782771|NCT02289157|183445025|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.||||0.44
91782772|NCT02289157|183445026|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing||||||0.68||||||Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.|Cochran-Mantel-Haenszel|||||||0.68
91593352|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.088|0.039|<0.0001
91593353|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.051|<0.0001
91593354|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.023|0.072||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.072|0.023|0.0001
91782773|NCT02289157|183445027|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing||||||0.27|||||||Cochran-Mantel-Haenszel|||||||0.27
91782774|NCT02289157|183445028|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing||||||0.55|||||||Cochran-Mantel-Haenszel|||||||0.55
91782775|NCT02289157|183445029|OTHER|Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing||||||0.49|||||||Cochran-Mantel-Haenszel|||||||0.49
91782776|NCT02289157|183445030|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity||||||0.92|||||||Cochran-Mantel-Haenszel|||||||0.92
91782777|NCT02289157|183445031|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.||||||0.22|||||||Cochran-Mantel-Haenszel|||||||0.22
91782778|NCT02289157|183445032|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity||||||0.74|||||||Cochran-Mantel-Haenszel|||||||0.74
91782779|NCT01388335|183445034|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.81|||||TWO_SIDED|90.0|0.691|0.95|||||Ratio of Geometric LS mean is for S-warfarin.|||0.950|0.691|
91782780|NCT01388335|183445034|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.912|||||TWO_SIDED|90.0|0.815|1.02|||||Ratio of Geometric LS mean is for R-warfarin.|||1.02|0.815|
91782781|NCT01388335|183445035|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.98|||||TWO_SIDED|90.0|0.76|3.5|||||Median Difference (Final Values) is for S-warfarin.|||3.50|0.76|
91782782|NCT01388335|183445035|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|-1.0|6.84|||||Median Difference (Final Values) is for R-warfarin.|||6.84|-1.00|
91782783|NCT01388335|183445036|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.28|||||TWO_SIDED|90.0|1.14|1.44|||||Ratio of Geometric LS mean is for S-warfarin.|||1.44|1.14|
91782784|NCT01388335|183445036|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.26|||||TWO_SIDED|90.0|1.08|1.47|||||Ratio of Geometric LS mean is for R-warfarin.|||1.47|1.08|
91782785|NCT01388335|183445041|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.92|||||TWO_SIDED|90.0|0.86|1.0|||||Ratio of Geometric LS mean.|||1.00|0.86|
91782786|NCT01388335|183445042|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Ratio of Geometric LS mean.|||1.02|0.95|
91782787|NCT01388335|183445045|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Mean|1.03||||||90.0|0.99|1.08|||||Ratio of Geometric LS mean for Period 2, Day 14, 0 hours.|||1.08|0.99|
91521684|NCT01971723|182918178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for auxiliary squat volume measure outcomes, only.||||>.05
91782788|NCT01388335|183445045|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Means|1.02|||||TWO_SIDED|90.0|0.98|1.06|||||Ratio of Geometric LS mean for Period 2, Day 14, 4 hours.|||1.06|0.98|
91782789|NCT00976560|183445051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.99|||TWO_SIDED|95.0|-2.54|1.35|||BMMRM|Bayesian Mixed Effects Model Repeated Measures (BMMRM)|Prior distribution of N(-4.1, 6.4009) incorporated into the posterior for the treatment difference at Week 6. The presented Confidence Interval is Highest Probability Density (HPD).||Posterior probability of the treatment difference being greater than 1.6 points in favor of GW856553 7.5mg BID as compared to placebo at Week 6 is 15.46 and for 0 is 72.98 and for 2 is 7.87.|1.35|-2.54|
91782790|NCT00125164|183445074|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.79|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.19|2.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.39|1.19|<0.0001
91782791|NCT00125164|183445074|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.99|3.16||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.16|1.99|< 0.0001
91782792|NCT00125164|183445074|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.79|STANDARD_ERROR_OF_MEAN|0.26||0.0032||95.0|0.27|1.31|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.31|0.27|0.0032
91593355|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.064|0.015|0.0014
91593356|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0554|TWO_SIDED|95.0|-0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|-0.001|0.0554
91593357|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|0.047|<0.0001
91593358|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0041|TWO_SIDED|95.0|0.011|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.060|0.011|0.0041
91593359|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.0248|TWO_SIDED|95.0|0.004|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.004|0.0248
91593360|NCT01431274|183077462|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5338|TWO_SIDED|95.0|-0.017|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.017|0.5338
91593361|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0017|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0017
91593362|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.09|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.186|0.090|<0.0001
91593363|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0426|TWO_SIDED|95.0|0.002|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.098|0.002|0.0426
91593364|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.074|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.170|0.074|<0.0001
91593365|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.063|0.159||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.159|0.063|<0.0001
91593366|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.025||0.2661|TWO_SIDED|95.0|-0.021|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.021|0.2661
91709210|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.716|TWO_SIDED|95.0|0.44|1.75|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||1.75|0.44|0.716
91521685|NCT01971723|182918178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for squat volume measure outcomes, only.||||>.05
91782793|NCT00125164|183445075|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.24|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.24|< 0.0001
91782794|NCT00125164|183445075|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.34|0.6||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.60|0.34|< 0.0001
91790326|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|7.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91521686|NCT01971723|182918178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for bench volume measure outcomes, only.||||>.05
91521687|NCT01971723|182918178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total squat volume measures, only.||||>.05
91521688|NCT01971723|182918178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total weight lifted volume measure outcomes, only.||||>.05
91521689|NCT01971723|182918179|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91521690|NCT01971723|182918180|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91521691|NCT01971723|182918181|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
91521692|NCT03017079|182918183|NON_INFERIORITY|a:0.05;β：0.01 P=.046||||||0.05|||||||t-test, 2 sided|||P=.046||||0.05
91521693|NCT03017079|182918184|NON_INFERIORITY|a 0.05|Odds Ratio (OR)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91521694|NCT03017079|182918185|SUPERIORITY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
91521695|NCT03017079|182918187|NON_INFERIORITY|According to the rule of a=0.05, P\<0.05 means that the hypothesis was true|||||<|0.05|||||||Chi-squared, Corrected|||||||<0.05
91521696|NCT04450108|182918188|SUPERIORITY|The change of FeNO values will be estimated in ANCOVA with baseline values as the covariable and will be reported as percent change together with the 95%-confidence interval.|||||<|0.001|||||||ANCOVA|||Since the effect size of the change (mean change / standard deviation) is on the order of 1 (resulting in N=10 and 13 for power = 80% and 90%, respectively) and therefore large, the sample size is not determined by the primary objective but by the necessity to achieve representative data of FeNO measurement data over all age groups, measurement ranges (\<, ≥ cut off) and sites. Thus, 120 subjects will be recruited.||||<0.001
91521697|NCT01255592|182918201|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.31||||0.004|TWO_SIDED|90.0|0.17|0.59|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.59|0.17|0.004
91521698|NCT01255592|182918202|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.64||||0.008|TWO_SIDED|90.0|0.49|0.84|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.84|0.49|0.008
91521699|NCT01255592|182918203|SUPERIORITY_OR_OTHER||LS mean difference|6.78|STANDARD_ERROR_OF_MEAN|3.298||0.047|TWO_SIDED|90.0|1.22|12.33|||ANCOVA|||The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.||12.33|1.22|0.047
91521700|NCT01255592|182918204|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.284|TWO_SIDED|90.0|-0.05|0.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.26|-0.05|0.284
91521701|NCT01255592|182918205|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.078||0.929|TWO_SIDED|90.0|-0.12|0.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.14|-0.12|0.929
91521702|NCT01255592|182918206|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.062||0.966|TWO_SIDED|90.0|-0.11|0.1|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.10|-0.11|0.966
91521703|NCT01255592|182918207|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.791|TWO_SIDED|90.0|-0.13|0.17|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.17|-0.13|0.791
91521704|NCT01255592|182918208|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.433|TWO_SIDED|90.0|-1.6|0.6|||ANCOVA|||The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.||0.6|-1.6|0.433
91521705|NCT01255592|182918209|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|8.03||0.935|TWO_SIDED|90.0|-12.81|14.13|||ANCOVA|||Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||14.13|-12.81|0.935
91521706|NCT01255592|182918209|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|7.35||0.654|TWO_SIDED|90.0|-9.02|15.64|||ANCOVA|||Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||15.64|-9.02|0.654
91521707|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.329|TWO_SIDED|90.0|-0.09|0.36|||ANCOVA|||Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.36|-0.09|0.329
91521708|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.664|TWO_SIDED|90.0|-0.16|0.27|||ANCOVA|||How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.27|-0.16|0.664
91521709|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|90.0|-0.04|0.54|||ANCOVA|||Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.54|-0.04|0.152
91521710|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.15|TWO_SIDED|90.0|-0.8|0.05|||ANCOVA|||What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.05|-0.80|0.150
91648648|NCT04288115|183190007|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.2||||0.1742|TWO_SIDED|95.0|-15.3|2.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline scores.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-month EQ-5D VAS score outcome.||2.9|-15.3|0.1742
91521711|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.248|TWO_SIDED|90.0|-0.06|0.35|||ANCOVA|||The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.35|-0.06|0.248
91521712|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.053|TWO_SIDED|90.0|-0.45|-0.04|||ANCOVA|||Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||-0.04|-0.45|0.053
91648649|NCT04288115|183190008|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-12.0||||0.1695|TWO_SIDED|95.0|-29.3|5.3||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline total cholesterol value.|Analysis of 6-month total cholesterol outcome.||5.3|-29.3|0.1695
91648650|NCT04288115|183190008|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.8||||0.3805|TWO_SIDED|95.0|-22.2|8.6||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline LDL values.|Analysis of 6-month LDL outcome.||8.6|-22.2|0.3805
91782795|NCT00125164|183445075|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0495||95.0|0.0|0.22|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.22|0.00|0.0495
91782796|NCT00125164|183445083|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|1.26|2.4||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.40|1.26|<0.0001
91782797|NCT00125164|183445083|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|2.26|3.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.39|2.26|<0.0001
91782798|NCT00125164|183445083|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.25||0.0002||95.0|0.5|1.51|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.51|0.50|0.0002
91782799|NCT00125164|183445084|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.25|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.25|<0.0001
91521713|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.179|TWO_SIDED|90.0|-0.04|0.42|||ANCOVA|||How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.42|-0.04|0.179
91790327|NCT02880956|183460059|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|1.294||0.427|TWO_SIDED|95.0|-1.515|3.575||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.575|-1.515|0.427
91521714|NCT01255592|182918210|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.942|TWO_SIDED|90.0|-0.75|0.68|||ANCOVA|||Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.68|-0.75|0.942
91521715|NCT01255592|182918211|SUPERIORITY_OR_OTHER||LS mean difference|-1.66|STANDARD_ERROR_OF_MEAN|3.374||0.625|TWO_SIDED|90.0|-7.32|4.0|||ANCOVA|||Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.00|-7.32|0.625
91521716|NCT01255592|182918211|SUPERIORITY_OR_OTHER||LS mean difference|-4.88|STANDARD_ERROR_OF_MEAN|3.342||0.151|TWO_SIDED|90.0|-10.49|0.74|||ANCOVA|||Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.74|-10.49|0.151
91593367|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.102|0.198||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.198|0.102|<0.0001
91709211|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|1.51||||0.328|TWO_SIDED|95.0|0.66|3.43|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||3.43|0.66|0.328
91782800|NCT00125164|183445084|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.39|0.64||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.64|0.39|<0.0001
91782801|NCT00125164|183445084|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||0.0071||95.0|0.04|0.26|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.26|0.04|0.0071
91782802|NCT01243580|183445124|EQUIVALENCE|Comparing Ortho-Cyclen to Ag200-15|||||<|0.0001|||||||ANOVA|||||||<0.0001
91782803|NCT01243580|183445125|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen|||||<|0.0001|||||||ANOVA|||||||<0.0001
91782804|NCT01243580|183445126|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen||||||0.0001|||||||ANOVA|||||||0.0001
91782805|NCT01243580|183445127|EQUIVALENCE|Comparison of Ortho-Cylen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
91782806|NCT01243580|183445128|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0009|||||||ANOVA|||||||0.0009
91782807|NCT01243580|183445129|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0167|||||||ANOVA|||||||0.0167
91782808|NCT01243580|183445130|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0007|||||||ANOVA|||||||0.0007
91782809|NCT01243580|183445131|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0175|||||||ANOVA|||||||0.0175
91782810|NCT01243580|183445132|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0001|||||||ANOVA|||||||0.0001
91782811|NCT01243580|183445133|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
91782812|NCT01301027|183445137|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
91782813|NCT01301027|183445138|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
91782814|NCT01301027|183445139|SUPERIORITY_OR_OTHER|||||||0.508|||||||t-test, 2 sided|||||||0.508
91782815|NCT01301027|183445140|SUPERIORITY_OR_OTHER|||||||0.984|||||||t-test, 2 sided|||||||0.984
91782816|NCT04308291|183445146|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|paired t-test||||||<0.0001
91782817|NCT01931566|183445170|OTHER|||||||0.023|||||||Regression, Cox|||||||0.023
91782818|NCT01931566|183445171|SUPERIORITY|||||||0.307|||||||Regression, Cox|||||||0.307
91782819|NCT04625101|183445178|SUPERIORITY|||||||0.4326|||||||ANCOVA|||||||0.4326
91782820|NCT02469870|183445220|SUPERIORITY|||||||0.598|||||||ANCOVA|||To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.598
91782821|NCT02469870|183445221|SUPERIORITY|||||||0.81|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.81
91782822|NCT02469870|183445222|SUPERIORITY|||||||0.404|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.404
91782823|NCT02469870|183445223|SUPERIORITY|||||||0.246|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.246
91782824|NCT02469870|183445224|SUPERIORITY|||||||0.007|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.007
91782825|NCT02469870|183445225|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Two-sample t-test||||.045
91782826|NCT00092443|183445235|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|72.5|||<|0.001||95.0|50.6|85.6|||Exact Binomial Test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||85.6|50.6|<0.001
91782827|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|56.7||||||95.0|44.0|66.8||||||||66.8|44.0|
91782828|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|2.7||||||95.0|0.3|9.5||||||||9.5|0.3|
91782829|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|14.5||||||95.0|6.9|25.8||||||||25.8|6.9|
91782830|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|5.1||||||||5.1|0.0|
91782831|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|9.0||||||95.0|3.4|18.5||||||||18.5|3.4|
91782832|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|4.8||||||||4.8|0.0|
91782833|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|39.7||||||95.0|27.6|52.8||||||||52.8|27.6|
91782834|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|1.4||||||95.0|0.0|7.7||||||||7.7|0.0|
91782835|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|24.6||||||95.0|14.5|37.3||||||||37.3|14.5|
91782836|NCT00092443|183445236|SUPERIORITY_OR_OTHER||Percent of Participants|2.9||||||95.0|0.4|10.1||||||||10.1|0.4|
91782837|NCT02685267|183445237|OTHER|The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.|log-rank test|0.6761||||0.6761|TWO_SIDED|95.0|||||Chi-squared|||The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.||||0.6761
91782838|NCT01027806|183445247|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91593368|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0119|TWO_SIDED|95.0|-0.109|-0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.014|-0.109|0.0119
91593369|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.073|STANDARD_ERROR_OF_MEAN|0.024||0.0029|TWO_SIDED|95.0|-0.121|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.121|0.0029
91593370|NCT01431274|183077463|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.024||0.6408|TWO_SIDED|95.0|-0.036|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.059|-0.036|0.6408
91593371|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.173|0.27||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.270|0.173|<0.0001
91593372|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.145|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.145|<0.0001
91593373|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.136|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.233|0.136|<0.0001
91593374|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.065|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.162|0.065|<0.0001
91593375|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.157|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.205||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.205|0.108|<0.0001
91593376|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.025||0.1355|TWO_SIDED|95.0|-0.012|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.085|-0.012|0.1355
91593377|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.151|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.102|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.199|0.102|<0.0001
91593378|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.025||0.2562|TWO_SIDED|95.0|-0.02|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.076|-0.020|0.2562
91648651|NCT04288115|183190008|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|1.7||||0.5724|TWO_SIDED|95.0|-4.44|7.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline HDL values.|Analysis of 6-month HDL outcome.||7.9|-4.44|0.5724
91648652|NCT04288115|183190008|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-17.8||||0.3939|TWO_SIDED|95.0|-59.4|23.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline triglyceride values.|Analysis of 6-month triglyceride outcome.||23.9|-59.4|0.3939
91593379|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0041|TWO_SIDED|95.0|0.022|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.119|0.022|0.0041
91593380|NCT01431274|183077464|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0815|TWO_SIDED|95.0|-0.091|0.005||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.005|-0.091|0.0815
91593381|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.195|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.149|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.149|<0.0001
91593382|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.107|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.199|0.107|<0.0001
91593383|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.174|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.128|0.221||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.221|0.128|<0.0001
91593384|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.061|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.154|0.061|<0.0001
91593385|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.086|0.178||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.178|0.086|<0.0001
91593386|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3727|TWO_SIDED|95.0|-0.025|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.067|-0.025|0.3727
91593387|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.082|0.175||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.175|0.082|<0.0001
91593388|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0744|TWO_SIDED|95.0|-0.004|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.004|0.0744
91593389|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.024||0.0047|TWO_SIDED|95.0|0.021|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.021|0.0047
91593390|NCT01431274|183077465|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.025|STANDARD_ERROR_OF_MEAN|0.024||0.2945|TWO_SIDED|95.0|-0.071|0.022||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.022|-0.071|0.2945
91648653|NCT00382291|183190020|SUPERIORITY_OR_OTHER|||||||0.2106||95.0|||||Kruskal-Wallis|||Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.||||.2106
91648654|NCT00382291|183190021|SUPERIORITY_OR_OTHER|||||||0.8831|TWO_SIDED|95.0|||||ANCOVA|||Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.||||.8831
91521717|NCT01255592|182918211|SUPERIORITY_OR_OTHER||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|4.524||0.773|TWO_SIDED|90.0|-8.91|6.28|||ANCOVA|||Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.28|-8.91|0.773
91782839|NCT02923921|183445269|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.6565|TWO_SIDED|95.0|0.863|1.265|||Log Rank|||The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).||1.265|0.863|0.6565
91521718|NCT01255592|182918211|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|3.845||0.92|TWO_SIDED|90.0|-6.84|6.07|||ANCOVA|||Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.07|-6.84|0.920
91521719|NCT01255592|182918212|SUPERIORITY_OR_OTHER||Ratio of LS means|0.69||||0.22|TWO_SIDED|90.0|0.42|1.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.14|0.42|0.220
91521720|NCT01255592|182918213|SUPERIORITY_OR_OTHER||Ratio of LS means|4.46|||<|0.001|TWO_SIDED|90.0|3.05|6.54|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.54|3.05|<0.001
91521721|NCT01255592|182918214|SUPERIORITY_OR_OTHER||Ratio of LS means|0.92||||0.67|TWO_SIDED|90.0|0.68|1.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.26|0.68|0.670
91521722|NCT01255592|182918215|SUPERIORITY_OR_OTHER||Ratio of LS means|0.99||||0.968|TWO_SIDED|90.0|0.78|1.27|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.27|0.78|0.968
91521723|NCT01255592|182918216|SUPERIORITY_OR_OTHER||Ratio of LS means|1.43||||0.193|TWO_SIDED|90.0|0.91|2.24|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.24|0.91|0.193
91521724|NCT01255592|182918217|SUPERIORITY_OR_OTHER||Ratio of LS means|3.24|||<|0.001|TWO_SIDED|90.0|2.19|4.79|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.79|2.19|<0.001
91521725|NCT01255592|182918218|SUPERIORITY_OR_OTHER||Ratio of LS means|1.02||||0.917|TWO_SIDED|90.0|0.71|1.48|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.48|0.71|0.917
91521726|NCT01255592|182918219|SUPERIORITY_OR_OTHER||Ratio of LS means|0.17||||0.111|TWO_SIDED|90.0|0.03|1.08|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.08|0.03|0.111
91521727|NCT01255592|182918220|SUPERIORITY_OR_OTHER||Ratio of LS means|1.33||||0.367|TWO_SIDED|90.0|0.79|2.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.26|0.79|0.367
91521728|NCT01255592|182918221|SUPERIORITY_OR_OTHER||Ratio of LS means|1.54||||0.112|TWO_SIDED|90.0|0.98|2.4|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.40|0.98|0.112
91521729|NCT01255592|182918222|SUPERIORITY_OR_OTHER||Ratio of LS means|1.05||||0.241|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.12|0.98|0.241
91521730|NCT01255592|182918223|SUPERIORITY_OR_OTHER||Ratio of LS means|5.5|||<|0.001|TWO_SIDED|90.0|4.18|7.23|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||7.23|4.18|<0.001
91521731|NCT01255592|182918224|SUPERIORITY_OR_OTHER||Ratio of LS means|1.16||||0.281|TWO_SIDED|90.0|0.92|1.47|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.47|0.92|0.281
91521732|NCT01255592|182918225|SUPERIORITY_OR_OTHER||Ratio of LS means|1.56||||0.001|TWO_SIDED|90.0|1.28|1.91|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.91|1.28|0.001
91521733|NCT01255592|182918226|SUPERIORITY_OR_OTHER||Ratio of LS means|6.07|||<|0.001|TWO_SIDED|90.0|4.42|8.35|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||8.35|4.42|<0.001
91521734|NCT03928028|182918229|SUPERIORITY|||||||0.507||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.507
91521735|NCT03928028|182918229|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.017
91521736|NCT03928028|182918229|SUPERIORITY|||||||0.139||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.139
91521737|NCT03928028|182918230|SUPERIORITY|||||||0.389|||||||generalized estimating equation|||This analysis compare mothers in FBT to mothers in FBT+CRTp||||.389
91521738|NCT03928028|182918230|SUPERIORITY|||||||0.447||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.447
91521739|NCT03928028|182918230|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||<.001
91521740|NCT03928028|182918231|SUPERIORITY|||||||0.778||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.778
91521741|NCT03928028|182918231|SUPERIORITY|||||||0.297||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.297
91521742|NCT03928028|182918231|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.062
91648655|NCT02270983|183190053|SUPERIORITY||Least squares mean difference|1.325|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|0.439|2.211|||ANCOVA|||||2.211|0.439|0.0035
91648656|NCT02270983|183190053|SUPERIORITY||Least squares mean difference|1.908|STANDARD_ERROR_OF_MEAN|0.451|<|0.0001|TWO_SIDED|95.0|1.021|2.796|||ANCOVA|||||2.796|1.021|<0.0001
91648657|NCT02270983|183190054|SUPERIORITY||Cox Proportional Hazard|1.28||||0.1429|TWO_SIDED|95.0|0.92|1.77|||Log Rank|||||1.77|0.92|0.1429
91782840|NCT02923921|183445270|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8144|TWO_SIDED|95.0|0.808|1.19|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||1.190|0.808|0.8144
91593391|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.205|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.155|0.255||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.255|0.155|<0.0001
91593392|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.107|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.206|0.107|<0.0001
91593393|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.142|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.142|<0.0001
91593394|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.124|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.074|0.174||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.174|0.074|<0.0001
91593395|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.144|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.193|0.094|<0.0001
91593396|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.025||0.6103|TWO_SIDED|95.0|-0.037|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.062|-0.037|0.6103
91593397|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.087|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.186|0.087|<0.0001
91648658|NCT02270983|183190054|SUPERIORITY||Cox Proportional Hazard|1.43||||0.0287|TWO_SIDED|95.0|1.04|1.97|||Log Rank|||||1.97|1.04|0.0287
91648659|NCT02270983|183190055|SUPERIORITY||Odds Ratio (OR)|1.37||||0.3332|TWO_SIDED|95.0|0.73|2.58|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||2.58|0.73|0.3332
91648660|NCT02270983|183190055|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0506|TWO_SIDED|95.0|1.0|3.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||3.68|1.00|0.0506
91648661|NCT02270983|183190056|SUPERIORITY||Least squares mean difference|0.751|STANDARD_ERROR_OF_MEAN|0.217||0.0007|TWO_SIDED|95.0|0.324|1.178|||ANCOVA|||||1.178|0.324|0.0007
91648662|NCT02270983|183190056|SUPERIORITY||Least squares mean difference|0.987|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|0.558|1.416|||ANCOVA|||||1.416|0.558|<0.0001
91648663|NCT02270983|183190057|SUPERIORITY||Least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.145||0.0017|TWO_SIDED|95.0|-0.746|-0.174|||ANCOVA|||||-0.174|-0.746|0.0017
91648664|NCT02270983|183190057|SUPERIORITY||Least squares mean difference|-0.669|STANDARD_ERROR_OF_MEAN|0.146|<|0.0001|TWO_SIDED|95.0|-0.957|-0.382|||ANCOVA|||||-0.382|-0.957|<0.0001
91648665|NCT02270983|183190058|SUPERIORITY||Least squares mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.205||0.872|TWO_SIDED|95.0|-0.371|0.437|||ANCOVA|||||0.437|-0.371|0.8720
91648666|NCT02270983|183190058|SUPERIORITY||Least squares mean difference|-0.607|STANDARD_ERROR_OF_MEAN|0.205||0.0034|TWO_SIDED|95.0|-1.011|-0.203|||ANCOVA|||||-0.203|-1.011|0.0034
91648667|NCT03840811|183190087|OTHER|||||||0.23|||||||Sign test|||To assess whether the fitness of a given mutant is different than that of wild-type, the ratio of colony-forming units of the mutant strain was compared to those of the WT strain at the time of treatment and in the inoculum using a Wilcoxon Signed-Rank Test with a significance level of 0.025. CIs of participants in Mixed FA1090 + FA7537 group were compared to mean = 1.||||0.230
91782841|NCT02923921|183445271|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7044|TWO_SIDED|95.0|0.4|1.7||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.7|0.4|0.7044
91521743|NCT03928028|182918232|SUPERIORITY|||||||0.069||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.069
91521744|NCT03928028|182918232|SUPERIORITY|||||||0.323||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.323
91521745|NCT03928028|182918232|SUPERIORITY|||||||0.225|||||||generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.225
91521746|NCT03928028|182918233|SUPERIORITY|||||||0.196||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.196
91521747|NCT03928028|182918233|SUPERIORITY|||||||0.812||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.812
91521748|NCT03928028|182918233|SUPERIORITY|||||||0.499||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.499
91521749|NCT03928028|182918234|SUPERIORITY|||||||0.446||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.446
91521750|NCT03928028|182918234|SUPERIORITY|||||||0.647|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.647
91521751|NCT03928028|182918234|SUPERIORITY|||||||0.765||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.765
91521752|NCT03928028|182918235|SUPERIORITY|||||||0.425||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.425
91521753|NCT03928028|182918235|SUPERIORITY|||||||0.63|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.630
91521754|NCT03928028|182918235|SUPERIORITY|||||||0.854||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.854
91521755|NCT02802501|182918240|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|0.001|TWO_SIDED|95.0|0.285|0.693|||Cox Proportional Hazard||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.693|0.285|<0.001
91521756|NCT02802501|182918241|SUPERIORITY||Hazard Ratio (HR)|1.722|||||TWO_SIDED|95.0|1.031|2.875|||||If hazard ratio was found to be \>1 then there are higher chances of relapse with Tafenoquine+DHA-PQP compared to Primaquine+DHA-PQP.|||2.875|1.031|
91521757|NCT02802501|182918242|SUPERIORITY||Hazard Ratio (HR)|0.258|||||TWO_SIDED|95.0|0.155|0.431|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Primaquine+DHA-PQP compared to DHA-PQP only.|||0.431|0.155|
91521758|NCT02802501|182918243|SUPERIORITY||Hazard Ratio (HR)|0.433|||||TWO_SIDED|95.0|0.273|0.686|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.686|0.273|
91521759|NCT05067439|182918279|OTHER||Ratio of Adjusted Geometric Means|288.81|||||TWO_SIDED|90.0|240.56|346.73||||||Omeprazole 10 mg was Reference and abrocitinib 200 mg + omeprazole 10 mg was Test. Natural log-transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||346.73|240.56|
91521760|NCT05067439|182918280|OTHER||Ratio of Adjusted Geometric Means|139.59|||||TWO_SIDED|90.0|121.98|159.74||||||Caffeine 100 mg was Reference and abrocitinib 200 mg + caffeine 100 mg was Test. Natural log-transformed AUCinfCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||159.74|121.98|
91521761|NCT05067439|182918281|OTHER||Ratio of Adjusted Geometric Means|110.1|||||TWO_SIDED|90.0|103.45|117.17||||||Efavirenz 50 mg was Reference and abrocitinib 200 mg + efavirenz 50 mg was Test. Natural log-transformed AUClastCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||117.17|103.45|
91521762|NCT02323646|182918291|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
91521763|NCT02323646|182918291|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
91521764|NCT02323646|182918292|SUPERIORITY|||||||0.0237|||||||Fisher Exact|||||||0.0237
91521765|NCT02323646|182918292|SUPERIORITY|||||||0.0272|||||||Fisher Exact|||||||0.0272
91521766|NCT02323646|182918293|SUPERIORITY|||||||0.0145|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0145
91521767|NCT02323646|182918293|SUPERIORITY|||||||0.0662|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0662
91521768|NCT02323646|182918293|SUPERIORITY|||||||0.0061|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0061
91521769|NCT02323646|182918293|SUPERIORITY|||||||0.0296|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0296
91521770|NCT02323646|182918294|SUPERIORITY|||||||0.2642|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2642
91521771|NCT02323646|182918294|SUPERIORITY|||||||0.4383|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.4383
91521772|NCT02323646|182918294|SUPERIORITY|||||||0.5333|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5333
91521773|NCT02323646|182918294|SUPERIORITY|||||||0.8791|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8791
91521774|NCT02323646|182918294|SUPERIORITY|||||||0.3666|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3666
91521775|NCT02323646|182918294|SUPERIORITY|||||||0.345|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3450
91521776|NCT02323646|182918295|SUPERIORITY|||||||0.0473|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0473
91593398|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0559|TWO_SIDED|95.0|-0.001|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.001|0.0559
91593399|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.025||0.0073|TWO_SIDED|95.0|0.018|0.118||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.118|0.018|0.0073
91593400|NCT01431274|183077466|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.02|STANDARD_DEVIATION|0.025||0.4368|TWO_SIDED|95.0|-0.07|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.030|-0.070|0.4368
91593401|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.196|0.098|<0.0001
91593402|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0023|TWO_SIDED|95.0|0.027|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.027|0.0023
91593403|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
91593404|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0545|TWO_SIDED|95.0|-0.001|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 μg).~Spatial power covariance structure for within-patient errors."|||0.097|-0.001|0.0545
91593405|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0456|TWO_SIDED|95.0|0.001|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.099|0.001|0.0456
91593406|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.025||0.2949|TWO_SIDED|95.0|-0.023|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.023|0.2949
91593407|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.074|STANDARD_ERROR_OF_MEAN|0.025||0.0029|TWO_SIDED|95.0|0.025|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.025|0.0029
91613943|NCT01505491|183121768|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|128.88|STANDARD_ERROR_OF_MEAN|1.08||0.6547|TWO_SIDED|90.0|113.492|146.365|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||146.365|113.492|0.6547
91613944|NCT01505491|183121768|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.24|STANDARD_ERROR_OF_MEAN|1.077||0.1572|TWO_SIDED|90.0|76.238|97.564|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||97.564|76.238|0.1572
91648668|NCT03840811|183190088|OTHER||Risk Difference (RD)|-0.14||||0.54|TWO_SIDED|95.0|-0.58|0.34||One-sided Fisher's Exact Test with alpha=0.025|Fisher Exact|||||0.34|-0.58|0.54
91613945|NCT01505491|183121769|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|110.3|STANDARD_ERROR_OF_MEAN|1.063||0.0212|TWO_SIDED|90.0|99.687|122.035|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.035|99.687|0.0212
91521777|NCT02323646|182918295|SUPERIORITY|||||||0.0191|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0191
91593408|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0045|TWO_SIDED|95.0|0.022|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.022|0.0045
91593409|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.073|STANDARD_ERROR_OF_MEAN|0.025||0.0035|TWO_SIDED|95.0|0.024|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.122|0.024|0.0035
91593410|NCT01431274|183077467|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.9369|TWO_SIDED|95.0|-0.051|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.051|0.9369
91593411|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.168|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.119|0.217||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.217|0.119|<0.0001
91593412|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.154|0.056|<0.0001
91593413|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.054|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.054|<0.0001
91593414|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.025||0.0585|TWO_SIDED|95.0|-0.002|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|-0.002|0.0585
91593415|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.025||0.1042|TWO_SIDED|95.0|-0.008|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|-0.008|0.1042
91593416|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.025||0.0097|TWO_SIDED|95.0|0.016|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.016|0.0097
91593417|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.063|0.161||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.161|0.063|<0.0001
91593418|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.025||0.012|TWO_SIDED|95.0|0.014|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.112|0.014|0.0120
91593419|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.025|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.105|0.007|0.0250
91648669|NCT02186808|183190096|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91521778|NCT02323646|182918295|SUPERIORITY|||||||0.0749|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0749
91521779|NCT02323646|182918295|SUPERIORITY|||||||0.0233|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0233
91521780|NCT02323646|182918295|SUPERIORITY|||||||0.7569|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7569
91782842|NCT02923921|183445272|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1463|TWO_SIDED|95.0|0.9|1.8||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.8|0.9|0.1463
91593420|NCT01431274|183077468|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.025||0.7889|TWO_SIDED|95.0|-0.042|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|-0.042|0.7889
91593421|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.187|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.138|0.237||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.237|0.138|<0.0001
91593422|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
91593423|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.103|0.202||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.202|0.103|<0.0001
91593424|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.025||0.0134|TWO_SIDED|95.0|0.013|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.111|0.013|0.0134
91593425|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0006|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.136|0.037|0.0006
91593426|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.025||0.167|TWO_SIDED|95.0|-0.015|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.084|-0.015|0.1670
91593427|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.048|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.048|0.0001
91593428|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.0085|TWO_SIDED|95.0|0.017|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.115|0.017|0.0085
91593429|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0003|TWO_SIDED|95.0|0.041|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.140|0.041|0.0003
91648670|NCT00472446|183190115|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||.028
91648671|NCT00472446|183190116|SUPERIORITY_OR_OTHER|||||||0.016|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||0.016
91648672|NCT00472446|183190116|SUPERIORITY_OR_OTHER|||||||0.723|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure pre-operative versus post-operative application||||0.723
91782843|NCT02923921|183445273|SUPERIORITY||Hazard Ratio (HR)|1.008||||0.9952|TWO_SIDED|95.0|0.37|2.741|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||2.741|0.370|0.9952
91521781|NCT02323646|182918295|SUPERIORITY|||||||0.5399|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5399
91521782|NCT02323646|182918296|SUPERIORITY|||||||0.1683|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1683
91593430|NCT01431274|183077469|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.025||0.3332|TWO_SIDED|95.0|-0.074|0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.025|-0.074|0.3332
91593431|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.105|0.201||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.201|0.105|<0.0001
91593432|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0016|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0016
91593433|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.18||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.180|0.084|<0.0001
91593434|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.024||0.0926|TWO_SIDED|95.0|-0.007|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.007|0.0926
91593435|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.024||0.0231|TWO_SIDED|95.0|0.008|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.103|0.008|0.0231
91593436|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3802|TWO_SIDED|95.0|-0.026|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.069|-0.026|0.3802
91593437|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.024||0.0105|TWO_SIDED|95.0|0.015|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.110|0.015|0.0105
91593438|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0018|TWO_SIDED|95.0|0.028|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.028|0.0018
91593439|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0002|TWO_SIDED|95.0|0.043|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.139|0.043|0.0002
91593440|NCT01431274|183077470|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.024||0.5554|TWO_SIDED|95.0|-0.062|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.034|-0.062|0.5554
91782844|NCT02923921|183445274|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.2298|TWO_SIDED|95.0|-11.6|2.8|||Log Rank|||||2.8|-11.6|0.2298
91782845|NCT04661579|183445302|OTHER||Vaccine Efficacy|35.9||||0.009|TWO_SIDED|95.0|10.3|54.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 1 and 4. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||54.2|10.3|0.009
91521783|NCT02323646|182918296|SUPERIORITY|||||||0.256|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2560
91521784|NCT02323646|182918296|SUPERIORITY|||||||0.4997|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.4997
91521785|NCT02323646|182918296|SUPERIORITY|||||||0.1334|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.1334
91648673|NCT00472446|183190118|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Fisher Exact|mid p value of the two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:"||||0.94
91648674|NCT00472446|183190118|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|mid p value of two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:"||||0.58
91648675|NCT00472446|183190119|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamol"||||0.328
91648676|NCT00472446|183190119|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizole"||||0.81
91648677|NCT00472446|183190119|SUPERIORITY_OR_OTHER|||||||0.331|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dose"||||0.331
91648678|NCT00472446|183190119|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dose"||||0.440
91648679|NCT00472446|183190120|SUPERIORITY_OR_OTHER|||||||0.925|TWO_SIDED||||||non-parametric ANOVA-type statistic|non-parametric ANOVA-type statistic for pooled main effects, full model||null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment||||0.925
91648680|NCT03211156|183190121|OTHER|||||||0.757|||||||Chi-squared, Corrected|||||||0.757
91790328|NCT02880956|183460059|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|7.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91521786|NCT02323646|182918296|SUPERIORITY|||||||0.0323|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.0323
91648681|NCT03211156|183190122|OTHER|||||||0.048|||||||Fisher Exact|||||||0.048
91648682|NCT01202994|183190133|OTHER||correlation coefficient|-0.45|||<|0.05|TWO_SIDED|||||This is a calculated p-value.|correlation|||The primary analysis is to examine the correlation between the practice effect z-score (presented in the Secondary Outcome section) and the standardized uptake value of flutemetamol (presented in the Outcome module).||||<0.05
91648683|NCT04126733|183190144|EQUIVALENCE|H0: ORR ≤ 5% versus H1: ORR \>5% The hypothesis was tested by a one-sided exact binomial test, assuming a background response rate for the combination to be at most 5%.|Rate|7.1||||0.2721||95.0|2.4|15.9||The target response rate for the combination treatment was 17%. Using a one-sided exact binomial test at a type-I error of at most 2.5% at least 8 responders out of the 70 patients were needed to achieve significance.|Exact Binomial Test|||||15.9|2.4|0.2721
91648684|NCT00837577|183190151|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.09|-0.75||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-0.75|-1.09|<.001
91648685|NCT00837577|183190152|SUPERIORITY_OR_OTHER||Least squares mean difference|-51.3|STANDARD_ERROR_OF_MEAN|5.6|<|0.001|TWO_SIDED|95.0|-62.3|-40.2||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-40.2|-62.3|<.001
91648686|NCT00837577|183190153|SUPERIORITY_OR_OTHER||Least squares mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-30.0|-15.0||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-15.0|-30.0|<.001
91648687|NCT00272961|183190165|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|8.37|STANDARD_ERROR_OF_MEAN|6.19||0.185|TWO_SIDED|95.0|-4.21|20.96|||ANCOVA|||Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.||20.96|-4.21|0.185
91648688|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|5.59||0.97|TWO_SIDED|95.0|-11.16|11.59|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.59|-11.16|0.970
91648689|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|5.71||0.994|TWO_SIDED|95.0|-11.66|11.57|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.57|-11.66|0.994
91648690|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.72||0.861|TWO_SIDED|95.0|-10.62|12.64|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||12.64|-10.62|0.861
91648691|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|4.9||0.221|TWO_SIDED|95.0|-3.79|15.99|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||15.99|-3.79|0.221
91648692|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|4.49||0.88|TWO_SIDED|95.0|-8.37|9.73|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.73|-8.37|0.880
91790329|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.69|TWO_SIDED|95.0|-0.083|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.083|0.690
91521787|NCT02323646|182918296|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
91521788|NCT02323646|182918297|SUPERIORITY|||||||0.6356|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.6356
91521789|NCT02323646|182918297|SUPERIORITY|||||||0.9539|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9539
91521790|NCT02323646|182918297|SUPERIORITY|||||||0.5219|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5219
91521791|NCT02323646|182918297|SUPERIORITY|||||||0.2678|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.2678
91521792|NCT02323646|182918297|SUPERIORITY|||||||0.3086|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3086
91521793|NCT02323646|182918297|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
91521794|NCT02323646|182918298|SUPERIORITY|||||||0.8393|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8393
91521795|NCT02323646|182918298|SUPERIORITY|||||||0.1361|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1361
91521796|NCT02323646|182918298|SUPERIORITY|||||||0.0382|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0382
91521797|NCT02323646|182918298|SUPERIORITY|||||||0.6273|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.6273
91521798|NCT02323646|182918298|SUPERIORITY|||||||0.8237|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.8237
91521799|NCT02323646|182918298|SUPERIORITY|||||||0.137|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.1370
91521800|NCT02323646|182918299|SUPERIORITY|||||||0.7949|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.7949
91521801|NCT02323646|182918299|SUPERIORITY|||||||0.1928|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1928
91521802|NCT02323646|182918299|SUPERIORITY|||||||1|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||1.0000
91521803|NCT02323646|182918299|SUPERIORITY|||||||0.392|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3920
91521804|NCT02323646|182918299|SUPERIORITY|||||||0.541|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5410
91521805|NCT02323646|182918299|SUPERIORITY|||||||0.4602|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4602
91521806|NCT02323646|182918300|SUPERIORITY|||||||0.9536|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9536
91521807|NCT02323646|182918300|SUPERIORITY|||||||0.1355|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1355
91521808|NCT02323646|182918300|SUPERIORITY|||||||0.9396|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9396
91521809|NCT02323646|182918300|SUPERIORITY|||||||0.9102|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9102
91521810|NCT02323646|182918300|SUPERIORITY|||||||0.6266|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6266
91782846|NCT04661579|183445303|OTHER||Vaccine Efficacy|-24.0||||0.369|TWO_SIDED|95.0|-97.0|22.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 2 and 5. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||22.2|-97|0.369
91782847|NCT04335136|183445320|OTHER|||||||0.5207||||||The level of significance was 5% (2-sided).|Chi-squared|||"Hypothesis tested: H0: pAPN01 = pPlacebo; H1: pAPN01 ≠ pPlacebo (with p=proportion of patients with event).~A total of 186 patients (93 per group) was estimated to yield 80% power to detect a 20% absolute risk reduction in the primary, from 50% in the placebo group to 30% in the APN01 group, at a 2-sided alpha of 0.05. To consider patients who would be randomized but not treated, a total of 200 patients (100 per group) were planned to be enrolled."||||0.5207
91782848|NCT04335136|183445320|OTHER||Odds Ratio (OR)|0.63||||0.3588|TWO_SIDED|95.0|0.23|1.7|||Regression, Logistic|Degree of freedom: 1||||1.70|0.23|0.3588
91593441|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.127|0.228||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.228|0.127|<0.0001
91593442|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0011|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.134|0.033|0.0011
91593443|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.142|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.091|0.192||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.192|0.091|<0.0001
91593444|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.026||0.1112|TWO_SIDED|95.0|-0.009|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.091|-0.009|0.1112
91593445|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.026||0.0632|TWO_SIDED|95.0|-0.003|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.003|0.0632
91593446|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1615|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.086|-0.014|0.1615
91593447|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.0027|TWO_SIDED|95.0|0.027|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.127|0.027|0.0027
91593448|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.144|0.044|0.0003
91593449|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.101|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.05|0.151||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.151|0.050|<0.0001
91648693|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|4.56||0.9|TWO_SIDED|95.0|-9.78|8.63|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||8.63|-9.78|0.900
91782849|NCT01396447|183445337|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1292|TWO_SIDED|95.0|-4.3|0.5||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|||0.5|-4.3|0.1292
91521811|NCT02323646|182918300|SUPERIORITY|||||||0.9302|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.9302
91593450|NCT01431274|183077471|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.026||0.7925|TWO_SIDED|95.0|-0.057|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.044|-0.057|0.7925
91593451|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.162|0.074|<0.0001
91593452|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.169|0.077|<0.0001
91593453|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.114|0.028|0.0012
91593454|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.137|0.050|<0.0001
91593455|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.121|0.031|0.0010
91593456|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.092|0.003|0.0384
91593457|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.185|0.097|<0.0001
91593458|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.040|-0.049|0.8428
91593459|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.020|-0.065|0.3048
91593460|NCT01431274|183077472|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.063|-0.027|0.4311
91593461|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.139|0.057|<0.0001
91593462|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.149|0.063|<0.0001
91782850|NCT01396447|183445337|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.3|-1.6||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|||-1.6|-6.3|0.0010
91593463|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.091|0.010|0.0136
91593464|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.116|0.035|0.0003
91593465|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.101|0.016|0.0065
91593466|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.089|0.005|0.0277
91782851|NCT01396447|183445337|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0374|TWO_SIDED|95.0|-4.9|-0.1||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|||-0.1|-4.9|0.0374
91593467|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.164|0.081|<0.0001
91593468|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.034|-0.049|0.7116
91593469|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.016|-0.065|0.2332
91593470|NCT01431274|183077473|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.059|-0.025|0.4374
91593471|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.244|0.077|0.0002
91593472|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.228|0.053|0.0017
91593473|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.210|0.046|0.0022
91593474|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.259|0.093|<0.0001
91593475|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.194|0.022|0.0141
91593476|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.118|-0.053|0.4581
91593477|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.293|0.124|<0.0001
91593478|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.105|-0.064|0.6335
91593479|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.034|-0.129|0.2530
91593480|NCT01431274|183077474|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.153|-0.017|0.1188
91593481|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.217|0.057|0.0008
91593482|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.209|0.042|0.0032
91593483|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.183|0.027|0.0085
91593484|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.235|0.077|0.0001
91593485|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.176|0.011|0.0255
91593486|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.113|-0.049|0.4393
91593487|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.269|0.108|<0.0001
91593488|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.092|-0.069|0.7784
91593489|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.026|-0.129|0.1965
91521812|NCT02323646|182918301|SUPERIORITY|||||||0.817|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8170
91593490|NCT01431274|183077475|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.144|-0.019|0.1315
91613946|NCT01505491|183121769|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|117.53|STANDARD_ERROR_OF_MEAN|1.066||0.17|TWO_SIDED|90.0|105.638|130.757|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||130.757|105.638|0.1700
91613947|NCT01505491|183121769|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|96.53|STANDARD_ERROR_OF_MEAN|1.064||0.0016|TWO_SIDED|90.0|87.064|107.017|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||107.017|87.064|0.0016
91521813|NCT02323646|182918301|SUPERIORITY|||||||0.8177|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8177
91593491|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-1.043|-3.239|0.0001
91593492|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||-0.033|-2.230|0.0435
91593493|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.432|-2.623|0.0063
91593494|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.577|-1.611|0.3545
91593495|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.578|-1.614|0.3542
91593496|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.476|-1.702|0.2697
91593497|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-2.227|0.0434
91593498|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.095|-2.114|0.0732
91782852|NCT01396447|183445338|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.3025|TWO_SIDED|95.0|-0.4|0.1|||Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||0.1|-0.4|0.3025
91782853|NCT01396447|183445338|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0044|TWO_SIDED|95.0|-0.6|-0.2|||Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.2|-0.6|0.0044
91782854|NCT01396447|183445338|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0489|TWO_SIDED|95.0|-0.5|0.0|||Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.0|-0.5|0.0489
91593499|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.092|-2.114|0.0724
91593500|NCT01431274|183077476|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.104|-1.102|0.9983
91613948|NCT02759146|183121772|SUPERIORITY||Difference between least squared means|0.09||||0.72|TWO_SIDED|95.0|-0.36|0.52||Adjusted for baseline and balancing factors used in the randomization|Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||.52|-.36|.72
91648694|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.71|STANDARD_ERROR_OF_MEAN|4.56||0.218|TWO_SIDED|95.0|-14.91|3.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||3.50|-14.91|0.218
91521814|NCT02323646|182918301|SUPERIORITY|||||||0.3167|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3167
91593501|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.718|-2.985|0.0014
91593502|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.686|-1.573|0.4413
91593503|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.304|-2.569|0.0129
91593504|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.070|-1.182|0.9222
91593505|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|ANCOVA|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||1.100|-1.157|0.9602
91593506|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.703|-1.533|0.4669
91593507|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.656|-1.598|0.4126
91593508|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.265|-2.551|0.0158
91613949|NCT02759146|183121772|SUPERIORITY||Difference between least squared means|-0.15||||0.58|TWO_SIDED|95.0|-0.72|0.41|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||.41|-.72|.58
91613950|NCT02759146|183121772|SUPERIORITY||Difference between least squared means|-0.24||||0.42|TWO_SIDED|95.0|-0.81|0.34|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||.34|-.81|.42
91613951|NCT02759146|183121773|SUPERIORITY||Difference between least squared means|-0.01||||0.96|TWO_SIDED|95.0|-0.44|0.42|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.42|-0.44|0.96
91613952|NCT02759146|183121773|SUPERIORITY||Difference between least squared means|-0.2||||0.48|TWO_SIDED|95.0|-0.75|0.35|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.35|-0.75|0.48
91613953|NCT02759146|183121773|SUPERIORITY||Difference between least squared means|-0.19||||0.52|TWO_SIDED|95.0|-0.75|0.38|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||0.38|-0.75|0.52
91593509|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.240|-2.521|0.0177
91593510|NCT01431274|183077477|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.109|-1.164|0.9624
91593511|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.862|0.329|<0.0001
91593512|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.907|0.373|<0.0001
91782855|NCT04693234|183445347|SUPERIORITY|||||||0.0054|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0054
91782856|NCT04693234|183445348|SUPERIORITY|||||||0.0127|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0127
91782857|NCT05814367|183445367|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used.|Least-square Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.025|0.014|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|The sample size of 38 was calculated to provide at least 90% statistical power to test Non-inferiority of the Test lens compared to the Control lens using a paired t-test with a two-sided type I error rate of 5%.||0.014|-0.025|
91782858|NCT00408200|183445417|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91782859|NCT00670306|183445430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_DEVIATION|7.1|<|0.001|||||||t-test, 2 sided|||||||<0.001
91782860|NCT04939415|183445498|SUPERIORITY||ratio of frequencies|0.0||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
91782861|NCT04939415|183445499|SUPERIORITY||ratio of frequencies|1.023||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
91782862|NCT04939415|183445501|SUPERIORITY||ratio of frequencies|1.073||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
91782863|NCT04939415|183445502|SUPERIORITY||ratio of frequencies|2.1||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
91782864|NCT04939415|183445504|SUPERIORITY||ratio of frequencies|3.243||||0.231|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.231
91782865|NCT04939415|183445505|SUPERIORITY||ratio of frequencies|0.034||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
91782866|NCT04939415|183445506|OTHER||ratio of frequencies|0.083||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
91782867|NCT04939415|183445508|SUPERIORITY||ratio of frequencies|1.213||||0.462|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.462
91782868|NCT04939415|183445509|SUPERIORITY||ratio of frequencies|0.153||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
91782869|NCT04939415|183445510|SUPERIORITY||F value|0.185||||0.668|TWO_SIDED||||||Mixed Models Analysis|Group by Day interaction||||||0.668
91782870|NCT04939415|183445511|SUPERIORITY||F value|0.032||||0.86|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.860
91782871|NCT04939415|183445512|SUPERIORITY||F value|0.035||||0.853|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.853
91782872|NCT04939415|183445513|SUPERIORITY||F value|0.0||||0.995|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.995
91782873|NCT04939415|183445514|SUPERIORITY||F value|1.27||||0.266|TWO_SIDED||||||Mixed Models Analysis|||||||0.266
91782874|NCT04939415|183445515|SUPERIORITY||F value|4.533||||0.039|TWO_SIDED||||||Mixed Models Analysis||group by day interaction is reported.|||||0.039
91782875|NCT04939415|183445515|SUPERIORITY||F Ratio|13.897|||<|0.001|TWO_SIDED||||||ANOVA|Degrees of freedom: 1,23||day 0 to day 14 for the mQFPD group were examined.||||<0.001
91782876|NCT04939415|183445515|SUPERIORITY||F ratio|0.41||||0.529|TWO_SIDED||||||ANOVA|degrees of freedom: 1,20||day 0 to day 14 for the Placebo Group were examined.||||0.529
91521815|NCT02323646|182918301|SUPERIORITY|||||||0.5503|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5503
91593513|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.690|0.156|0.0019
91593514|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.712|0.179|0.0011
91593515|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.735|0.201|0.0006
91593516|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.438|-0.094|0.2045
91593517|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.885|0.351|<0.0001
91593518|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.223|-0.313|0.7432
91593519|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.245|-0.290|0.8687
91593520|NCT01431274|183077478|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.246|-0.290|0.8709
91593521|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.898|0.362|<0.0001
91593522|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.703|0.166|0.0015
91593523|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.687|0.151|0.0022
91613954|NCT02759146|183121774|SUPERIORITY||Difference between least squared means|0.67||||0.68|TWO_SIDED|95.0|-2.52|3.86|||Mixed Models Analysis||Comparing reflexology to meditative practices for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||3.86|-2.52|.68
91782877|NCT04939415|183445516|SUPERIORITY||ratio of frequencies|0.14||||0.71|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.710
91782878|NCT04939415|183445517|SUPERIORITY||F value|2.855||||0.099|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.099
91782879|NCT04939415|183445518|SUPERIORITY||F value|1.497||||0.228|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.228
91782880|NCT04939415|183445519|SUPERIORITY||F value|2.537||||0.119|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.119
91782881|NCT04939415|183445520|SUPERIORITY||F value|0.219||||0.643|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.643
91782882|NCT04939415|183445521|SUPERIORITY||F value|0.054||||0.817|TWO_SIDED||||||Mixed Models Analysis|||||||0.817
91782883|NCT04939415|183445522|SUPERIORITY||F value|0.315||||0.578|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.578
91593524|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.495|-0.041|0.0966
91593525|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.492|-0.045|0.1029
91593526|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.478|-0.056|0.1220
91593527|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.707|0.170|0.0014
91593528|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.465|-0.074|0.1542
91593529|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.461|-0.077|0.1626
91593530|NCT01431274|183077479|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.274|-0.265|0.9765
91593531|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.925|0.370|<0.0001
91613955|NCT02759146|183121774|SUPERIORITY||Difference between least squared means|-2.53||||0.23|TWO_SIDED|95.0|-6.64|1.58|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||1.58|-6.64|.23
91782884|NCT04939415|183445523|SUPERIORITY||F value|0.215||||0.643|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.643
91782885|NCT04939415|183445524|SUPERIORITY||F value|1.987||||0.159|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.159
91782886|NCT00478023|183445538|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|18.1|||<|0.0001||95.0|10.9|25.3||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||25.3|10.9|<0.0001
91782887|NCT00478023|183445538|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.8|||<|0.0001||95.0|13.7|28.0||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||28.0|13.7|<0.0001
91782888|NCT00478023|183445538|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|23.3|||<|0.0001||95.0|16.3|30.4||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||30.4|16.3|<0.0001
91648695|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|5.62|STANDARD_ERROR_OF_MEAN|2.68||0.044|TWO_SIDED|95.0|0.17|11.08|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.08|0.17|0.044
91782889|NCT00478023|183445538|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.6|||<|0.0001||95.0|13.4|27.8||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||27.8|13.4|<0.0001
91782890|NCT00478023|183445539|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|37.1|||<|0.0001||95.0|21.6|52.6||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||52.6|21.6|<0.0001
91593532|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.600|0.045|0.0226
91593533|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.649|0.093|0.0089
91521816|NCT02323646|182918301|SUPERIORITY|||||||0.6929|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6929
91521817|NCT02323646|182918301|SUPERIORITY|||||||0.726|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7260
91521818|NCT02323646|182918302|SUPERIORITY|||||||0.3896|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.3896
91521819|NCT02323646|182918302|SUPERIORITY|||||||0.1358|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1358
91521820|NCT02323646|182918302|SUPERIORITY|||||||0.7903|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.7903
91521821|NCT02323646|182918302|SUPERIORITY|||||||0.8206|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8206
91521822|NCT02323646|182918302|SUPERIORITY|||||||0.7891|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7891
91521823|NCT02323646|182918302|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4010
91521824|NCT02323646|182918303|SUPERIORITY|||||||0.0294|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0294
91521825|NCT02323646|182918303|SUPERIORITY|||||||0.1934|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1934
91521826|NCT02323646|182918303|SUPERIORITY|||||||0.0442|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0442
91521827|NCT02323646|182918303|SUPERIORITY|||||||0.8314|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8314
91521828|NCT00089141|182918304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.22||95.0|0.7|3.7||P values are 2 sided and are based on likelihood ratio statistics.|Regression, Cox|Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.|For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.|||3.7|0.7|.22
91521829|NCT00089141|182918305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.03||95.0|1.1|2.6|||Regression, Cox|Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).||||2.6|1.1|.03
91521830|NCT00089141|182918306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.55||95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|.55
91521831|NCT00089141|182918307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.48||95.0|0.4|6.0|||Regression, Cox|||||6.0|0.4|.48
91521832|NCT00089141|182918308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.17||95.0|0.8|3.9|||Regression, Cox|adjusted for risk category||||3.9|0.8|.17
91521833|NCT00089141|182918309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.41||95.0|0.5|5.0|||Regression, Cox|||||5.0|0.5|.41
91521834|NCT00089141|182918310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.69||||0.14||95.0|0.9|3.2|||Regression, Cox|||||3.2|0.9|.14
91521835|NCT00089141|182918311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99||||0.1||95.0|0.9|4.3|||Regression, Cox|||||4.3|0.9|.10
91521836|NCT00089141|182918312|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.34||95.0|0.08|2.1|||Regression, Cox|||||2.1|.08|.34
91521837|NCT00089141|182918313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.28||95.0|0.7|3.2|||Regression, Cox|||||3.2|0.7|.28
91521838|NCT02459262|182918321|OTHER|ANOVA repeated measures: In-transformed antibody concentrations as dependent variable; dose level, time, presence of adjuvant and dose\*time interaction as fixed effects; subjects as random effects||||||0.0193||||||Adjuvant effect at Day 85, the primary immunological endpoint|ANOVA|Adjuvant effect, with higher antibody concentration values after all dose levels of vaccine was significant at all time points (D29, D43, D57, Day 85)||The objectives for Part A were to evaluate the effect of adjuvant and to inform the selection of dose levels for Part B. The study was not powered for inter-group comparisons.||||0.0193
91521839|NCT02459262|182918322|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91521840|NCT02459262|182918323|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91521841|NCT05168579|182918326|SUPERIORITY||Odds Ratio (OR)|13.8|||<|0.001|TWO_SIDED|95.0|2.76|69.6|||Mixed Models Analysis|||||69.6|2.76|<0.001
91613956|NCT02759146|183121774|SUPERIORITY||Difference between least squared means|-3.2||||0.14|TWO_SIDED|95.0|-7.41|1.01|||Mixed Models Analysis||Comparing meditative practice to control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||1.01|-7.41|0.14
91648696|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.41||0.557|TWO_SIDED|95.0|-3.47|6.33|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.33|-3.47|0.557
91648697|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|6.37|STANDARD_ERROR_OF_MEAN|2.5||0.016|TWO_SIDED|95.0|1.28|11.45|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.45|1.28|0.016
91648698|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|2.5||0.695|TWO_SIDED|95.0|-4.09|6.07|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.07|-4.09|0.695
91648699|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.56||0.067|TWO_SIDED|95.0|-0.36|9.95|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.95|-0.36|0.067
91648700|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.36||0.737|TWO_SIDED|95.0|-3.96|5.55|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||5.55|-3.96|0.737
91648701|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|2.4||0.023|TWO_SIDED|95.0|0.8|10.47|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||10.47|0.80|0.023
91648702|NCT00272961|183190165|SUPERIORITY_OR_OTHER||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|2.4||0.495|TWO_SIDED|95.0|-3.2|6.5|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.50|-3.20|0.495
91648703|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|232.59|STANDARD_ERROR_OF_MEAN|201.83||0.2577|TWO_SIDED|95.0|-178.5|643.7|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||643.7|-178.5|0.2577
91648704|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|103.67|STANDARD_ERROR_OF_MEAN|173.86||0.5552|TWO_SIDED|95.0|-250.5|457.8|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||457.8|-250.5|0.5552
91648705|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|41.26|STANDARD_ERROR_OF_MEAN|177.26||0.8174|TWO_SIDED|95.0|-319.8|402.3|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||402.3|-319.8|0.8174
91648706|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|166.4|STANDARD_ERROR_OF_MEAN|177.55||0.3557|TWO_SIDED|95.0|-195.3|528.1|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||528.1|-195.3|0.3557
91648707|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|163.04|STANDARD_ERROR_OF_MEAN|130.15||0.2172|TWO_SIDED|95.0|-99.6|425.7|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||425.7|-99.6|0.2172
91648708|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|115.35|STANDARD_ERROR_OF_MEAN|116.03||0.3258|TWO_SIDED|95.0|-118.8|349.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||349.5|-118.8|0.3258
91648709|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|117.88||0.8352|TWO_SIDED|95.0|-213.2|262.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||262.6|-213.2|0.8352
91648710|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|50.59|STANDARD_ERROR_OF_MEAN|117.93||0.6701|TWO_SIDED|95.0|-187.4|288.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||288.6|-187.4|0.6701
91648711|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|225.57|STANDARD_ERROR_OF_MEAN|108.95||0.0466|TWO_SIDED|95.0|3.6|447.5|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||447.5|3.6|0.0466
91648712|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|114.77|STANDARD_ERROR_OF_MEAN|93.2637||0.2274|TWO_SIDED|95.0|-75.2|304.8|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||304.8|-75.2|0.2274
91648713|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|224.89|STANDARD_ERROR_OF_MEAN|96.9259||0.0269|TWO_SIDED|95.0|27.5|422.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||422.3|27.5|0.0269
91593534|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.609|0.056|0.0186
91593535|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.324|-0.231|0.7441
91593536|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 μg).~Spatial power covariance structure for within-patient errors."|||0.551|0.001|0.0492
91593537|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.884|0.332|<0.0001
91593538|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.605|0.045|0.0230
91593539|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.317|-0.240|0.7855
91593540|NCT01431274|183077480|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.564|0.007|0.0442
91593541|NCT00053703|183077484|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91648714|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|133.22|STANDARD_ERROR_OF_MEAN|96.7383||0.178|TWO_SIDED|95.0|-63.8|330.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||330.3|-63.8|0.1780
91593542|NCT04261504|183077499|SUPERIORITY|||||||0.03||||||Threshold p\<0.05.|threshold-free cluster enhancement|||||||0.03
91593543|NCT00397033|183077503|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.001
91648715|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|240.64|STANDARD_ERROR_OF_MEAN|114.32||0.0413|TWO_SIDED|95.0|9.9|471.4|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||471.4|9.9|0.0413
91593544|NCT00397033|183077503|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.008
91593545|NCT00397033|183077504|SUPERIORITY_OR_OTHER||LS Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-5.1|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.7|-5.1|<0.001
91593546|NCT00397033|183077504|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.217||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.217
91648716|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|157.99|STANDARD_ERROR_OF_MEAN|102.21||0.1297|TWO_SIDED|95.0|-48.3|364.3|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||364.3|-48.3|0.1297
91648717|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|254.9|STANDARD_ERROR_OF_MEAN|104.0||0.0185|TWO_SIDED|95.0|45.0|464.8|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||464.8|45.0|0.0185
91521842|NCT01242748|182918328|NON_INFERIORITY_OR_EQUIVALENCE|Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.|Hazard Ratio (HR)|0.774||||0.1589|TWO_SIDED|95.0|0.542|1.106|||Cox proportional hazard model|||The hazard ratio of PSA PFS failure rates was estimated using the Cox proportional hazard model with time to PSA PFS failure as dependent and treatment as independent variables and adjusted for baseline PSA category, prostate cancer stage, weight and geographical region. Degarelix was to be considered non-inferior to goserelin if the upper limit of the two-sided 95% confidence interval (CI) of the adjusted hazard ratio was less than or equal to the non-inferiority margin of 1.33.||1.106|0.542|0.1589
91521843|NCT01242748|182918329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783||||0.1244|TWO_SIDED|95.0|0.574|1.07|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.070|0.574|0.1244
91521844|NCT01242748|182918330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856|||||TWO_SIDED|95.0|0.58|1.263||||||The hazard ratio was estimated using the Cox proportional hazard model.||1.263|0.580|
91648718|NCT00272961|183190166|SUPERIORITY_OR_OTHER||LS Mean Difference|157.66|STANDARD_ERROR_OF_MEAN|104.33||0.1382|TWO_SIDED|95.0|-52.9|368.2|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||368.2|-52.9|0.1382
91521845|NCT01242748|182918331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.511||||0.0005|TWO_SIDED|95.0|1.739|7.09|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||7.090|1.739|0.0005
91521846|NCT01242748|182918332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.143|TWO_SIDED|95.0|0.493|1.108|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.108|0.493|0.143
91521847|NCT01242748|182918333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.2212|TWO_SIDED|95.0|0.259|1.368|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.368|0.259|0.2212
91521848|NCT02347657|182918379|SUPERIORITY||Least Squares (LS) Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|3.1|4.8|||Mixed model for repeated measures (MMRM)|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||4.8|3.1|<0.0001
91521849|NCT02347657|182918380|SUPERIORITY||LS mean difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.3|8.3|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||8.3|5.3|<0.0001
91521850|NCT02347657|182918381|SUPERIORITY||Event Rate Ratio|0.65||||0.0054|TWO_SIDED|95.0|0.48|0.88|||Negative Binomial Regression|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.88|0.48|0.0054
91521851|NCT02347657|182918382|SUPERIORITY||LS mean difference|0.06||||0.4127|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.19|-0.08|0.4127
91521852|NCT00677352|182918397|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.5|1.6|||ANCOVA|||The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.||1.6|-2.5|
91521853|NCT00677352|182918403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).|Fisher Exact|||||||0.0062
91593547|NCT00397033|183077505|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.108||95.0|-2.3|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-2.3|0.108
91593548|NCT00397033|183077505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.43||95.0|-1.7|0.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.7|-1.7|0.430
91593549|NCT00397033|183077506|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.5||0.008||95.0|-6.7|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-6.7|0.008
91521854|NCT02182973|182918404|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91613957|NCT02759146|183121775|SUPERIORITY||Difference between least squared means|0.01||||0.98|TWO_SIDED|95.0|-0.38|0.39|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.39|-0.38|0.98
91613958|NCT02759146|183121775|SUPERIORITY||Difference between least squared means|-0.24||||0.34|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.25|-0.74|0.34
91613959|NCT02759146|183121775|SUPERIORITY||Difference between least squared means|-0.25||||0.34|TWO_SIDED|95.0|-0.76|0.26|||Mixed Models Analysis||Comparing meditative practices vs control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||0.26|-0.76|0.34
91613960|NCT02759146|183121776|SUPERIORITY||Difference between least squared means|0.25||||0.57|TWO_SIDED|95.0|-0.63|1.14|||Mixed Models Analysis||After the initial 4 weeks of reflexology, comparing continued reflexology to added meditative practice|Aim 2: After 4 weeks of reflexology, comparing continuing reflexology vs adding meditative practice||1.14|-.63|0.57
91613961|NCT02759146|183121776|SUPERIORITY||Least Square (LS) Mean|0.49||||0.39|TWO_SIDED|95.0|-0.64|1.63|||Mixed Models Analysis||After the initial 4 weeks of meditative practices, comparing continuing meditative practice to adding reflexology|Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12||1.63|-0.64|0.39
91613962|NCT02759146|183121777|SUPERIORITY||Least Square (LS) Mean|1.94||||0.67|TWO_SIDED|95.0|-10.93|7.04|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||7.04|-10.93|0.67
91613963|NCT02759146|183121777|SUPERIORITY||Least Square (LS) Mean|-1.85||||0.66|TWO_SIDED|95.0|-6.59|10.29|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12||10.29|-6.59|0.66
91613964|NCT02759146|183121778|SUPERIORITY||Difference between least squared means|-0.19||||0.62|TWO_SIDED|95.0|-0.95|0.57|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||0.57|-0.95|0.62
91613965|NCT02759146|183121778|SUPERIORITY||Least Square (LS) Mean|-0.04||||0.95|TWO_SIDED|95.0|-1.15|1.22|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12||1.22|-1.15|0.95
91613966|NCT02759146|183121779|SUPERIORITY||Difference between least squared means|-0.14||||0.77|TWO_SIDED|95.0|-1.04|0.77|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice for weeks 5-12||0.77|-1.04|0.77
91613967|NCT02759146|183121779|SUPERIORITY||Least Square (LS) Mean|0.22||||0.67|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12||0.80|-1.23|0.67
91613968|NCT02759146|183121780|SUPERIORITY||Least Square (LS) Mean|0.09||||0.42|TWO_SIDED|95.0|-0.88|0.37|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.37|-0.88|0.42
91613969|NCT02759146|183121780|SUPERIORITY||Least Square (LS) Mean|-0.34||||0.29|TWO_SIDED|95.0|-0.98|0.29|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practices vs control for weeks 5-12||0.29|-0.98|0.29
91613970|NCT02759146|183121781|SUPERIORITY||Least Square (LS) Mean|-0.42||||0.15|TWO_SIDED|95.0|-1.0|0.15|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.15|-1.00|0.15
91613971|NCT02759146|183121781|SUPERIORITY||Least Square (LS) Mean|-0.2||||0.5|TWO_SIDED|95.0|-0.8|0.39|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.39|-0.80|0.50
91613972|NCT02759146|183121782|SUPERIORITY||Least Square (LS) Mean|-0.27||||0.33|TWO_SIDED|95.0|-0.83|0.28|||Mixed Models Analysis||Comparing reflexology vs control for week 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.28|-0.83|0.33
91613973|NCT02759146|183121782|SUPERIORITY||Least Square (LS) Mean|-0.36||||0.22|TWO_SIDED|95.0|-0.93|0.21|||Mixed Models Analysis|||Aim 4: Comparing meditative practice vs control for weeks 5-12||0.21|-0.93|0.22
91521855|NCT02182973|182918405|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||0.875
91521856|NCT02182973|182918406|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
91521857|NCT00762450|182918407|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|paired t-tests||The null hypothesis states that there is no difference between groups.||||0.05
91521858|NCT05614089|182918408|SUPERIORITY|||||||0.43||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||6-month (primary)||||0.43
91521859|NCT05614089|182918408|SUPERIORITY|||||||0.008||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||12-month||||0.008
91521860|NCT05614089|182918409|SUPERIORITY|||||||0.71||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||6-month (primary)||||0.71
91521861|NCT05614089|182918409|SUPERIORITY|||||||0.64||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||12-month||||0.64
91521862|NCT05614089|182918410|SUPERIORITY|||||||0.54|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||6-month||||0.54
91521863|NCT05614089|182918410|SUPERIORITY|||||||0.07|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||12-month||||0.07
91521864|NCT05614089|182918411|SUPERIORITY|||||||0.58|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||6-month||||0.58
91521865|NCT05614089|182918411|SUPERIORITY|||||||0.21|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||12-month||||0.21
91521866|NCT05614089|182918412|SUPERIORITY|||||||0.7|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||6-month||||0.70
91521867|NCT05614089|182918412|SUPERIORITY|||||||0.02|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||12-month||||0.02
91521868|NCT05614089|182918413|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||6-month||||0.81
91521869|NCT05614089|182918413|SUPERIORITY|||||||0.29|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||12-month||||0.29
91521870|NCT05614089|182918414|SUPERIORITY|||||||0.98|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.98
91521871|NCT05614089|182918414|SUPERIORITY|||||||0.61|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.61
91521872|NCT05614089|182918415|SUPERIORITY|||||||0.83|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.83
91521873|NCT05614089|182918415|SUPERIORITY|||||||0.09|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.09
91521874|NCT05614089|182918416|SUPERIORITY|||||||0.95|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||6-month||||0.95
91521875|NCT05614089|182918416|SUPERIORITY|||||||0.73|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||12-month||||0.73
91521876|NCT05614089|182918417|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||6-month||||0.81
91521877|NCT05614089|182918417|SUPERIORITY|||||||0.44|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||12-month||||0.44
91521878|NCT05614089|182918418|SUPERIORITY|||||||0.04|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||6-month||||0.04
91593550|NCT00397033|183077506|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.175||95.0|-4.8|0.9|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.9|-4.8|0.175
91593551|NCT00397033|183077507|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.9||0.001||95.0|-4.6|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.1|-4.6|0.001
91593552|NCT00397033|183077507|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.209||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.209
91593553|NCT00397033|183077509|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.6||0.032||95.0|-6.5|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-6.5|0.032
91593554|NCT00397033|183077509|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.5||0.013||95.0|-6.8|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.8|-6.8|0.013
91593555|NCT00397033|183077510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.232||95.0|-2.0|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-2.0|0.232
91593556|NCT00397033|183077510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.31||95.0|-1.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-1.8|0.310
91593557|NCT00397033|183077511|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.004||95.0|-3.1|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.6|-3.1|0.004
91593558|NCT00397033|183077511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.269||95.0|-1.9|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.9|0.269
91593559|NCT00397033|183077512|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.2|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-3.2|<0.001
91593560|NCT00397033|183077512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.314||95.0|-1.7|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.7|0.314
91593561|NCT00397033|183077513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.071||95.0|-1.8|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.8|0.071
91593562|NCT00397033|183077513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.099||95.0|-1.7|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.7|0.099
91593563|NCT00397033|183077515|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-0.9|<0.001
91593564|NCT00397033|183077515|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.083||95.0|-0.6|0.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.6|0.083
91593565|NCT00397033|183077516|SUPERIORITY_OR_OTHER||LS Means Difference|-8.3|STANDARD_ERROR_OF_MEAN|2.8||0.003||95.0|-13.8|-2.9||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||-2.9|-13.8|0.003
91593566|NCT00397033|183077516|SUPERIORITY_OR_OTHER||LS Means Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.7||0.187||95.0|-9.0|1.8||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||1.8|-9.0|0.187
91593567|NCT00397033|183077517|SUPERIORITY_OR_OTHER||LS Means Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.1|-0.4|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.|||-0.4|-1.1|<0.001
91593568|NCT00397033|183077517|SUPERIORITY_OR_OTHER||LS Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.029||95.0|-0.7|0.0|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.7|0.029
91593569|NCT00397033|183077519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.9|-3.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-3.7|-9.9|<0.001
91593570|NCT00397033|183077519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.5||0.066||95.0|-5.8|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-5.8|0.066
91593571|NCT01020591|183077527|NON_INFERIORITY_OR_EQUIVALENCE|The power and sample size calculations, based on the ability to detect treatment and evaluation group differences, were performed on Minitab™ V.15. 40 participants were estimated to be required for group allocation (20 in each group: evaluation;evaluation and treatment)for 80% power in at least 3 out of the 4 outcome measures. After 30 subjects, analysis determined that there would be no further statistically significant changes in results therefore, data collection was stopped at 30 subjects.|||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Index||||<0.05
91593572|NCT02426476|183077545|SUPERIORITY||||||<|0.01||||||Group by Time interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
91593573|NCT02426476|183077546|SUPERIORITY|||||||0.87||||||Group by Time interaction|Mixed Models Analysis|||||||0.87
91593574|NCT02426476|183077547|SUPERIORITY||||||<|0.01||||||Group by Time Interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
91593575|NCT00807742|183077554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.606|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.606
91593576|NCT00807742|183077555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.29|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.290
91593577|NCT00807742|183077556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.32|TWO_SIDED|95.0|0.49|8.23|||Chi-squared|||||8.23|0.49|.32
91593578|NCT00807742|183077557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.298|TWO_SIDED|95.0|0.51|8.45|||Chi-squared|||||8.45|0.51|.298
91593579|NCT00807742|183077558|SUPERIORITY||Effect Size d|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||t-test, 2 sided|||||-0.27|-0.71|<.001
91593580|NCT00807742|183077559|SUPERIORITY||Effect Size d|-0.15||||0.199|TWO_SIDED|95.0|-0.38|0.08|||t-test, 2 sided|||||0.08|-0.38|.199
91593581|NCT00807742|183077560|SUPERIORITY||Effect Size d|-0.12||||0.148|TWO_SIDED|95.0|-0.57|0.33|||t-test, 2 sided|||||0.33|-.57|.148
91593582|NCT00807742|183077561|SUPERIORITY||Effect Size d|-0.15||||0.249|TWO_SIDED|95.0|-0.4|0.11|||t-test, 2 sided|||||0.11|-0.40|.249
91593583|NCT00807742|183077562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.402|TWO_SIDED|95.0|0.59|3.72|||Chi-squared|||||3.72|0.59|0.402
91593584|NCT00807742|183077563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.772|TWO_SIDED|95.0|0.49|1.7|||Chi-squared|||||1.70|0.49|.772
91593585|NCT00807742|183077564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.6|1.77|||Chi-squared|||||1.77|0.60|.910
91593586|NCT00807742|183077565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.812|TWO_SIDED|95.0|0.54|1.62|||Chi-squared|||||1.62|0.54|.812
91593587|NCT00807742|183077566|SUPERIORITY||Odds Ratio (OR)|0.76||||0.49|TWO_SIDED|95.0|0.36|1.65|||Chi-squared|||||1.65|0.36|.490
91782891|NCT00478023|183445539|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|44.0|||<|0.0001||95.0|28.6|59.5||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariates.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||59.5|28.6|<0.0001
91593588|NCT00807742|183077567|SUPERIORITY||Odds Ratio (OR)|1.19||||0.511|TWO_SIDED|95.0|0.67|2.06|||Chi-squared|||||2.06|0.67|.511
91593589|NCT00807742|183077568|SUPERIORITY||Odds Ratio (OR)|1.19||||0.499|TWO_SIDED|95.0|0.72|1.97|||Chi-squared|||||1.97|0.72|.499
91593590|NCT00807742|183077569|SUPERIORITY||Odds Ratio (OR)|0.96||||0.876|TWO_SIDED|95.0|0.58|1.6|||Chi-squared|||||1.60|0.58|.876
91593591|NCT00807742|183077570|SUPERIORITY_OR_OTHER||Effect Size d|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||t-test, 2 sided|||||-0.15|-0.59|.001
91593592|NCT00807742|183077571|SUPERIORITY_OR_OTHER||Effect Size d|-0.25||||0.069|TWO_SIDED|95.0|-0.46|0.02|||t-test, 2 sided|||||0.02|-0.46|.069
91593593|NCT00807742|183077572|SUPERIORITY_OR_OTHER||Effect Size d|-0.16||||0.202|TWO_SIDED|95.0|-0.4|0.08|||t-test, 2 sided|||||0.08|-0.40|.202
91593594|NCT00807742|183077573|SUPERIORITY_OR_OTHER||Effect Size d|-0.17||||0.199|TWO_SIDED|95.0|-0.42|0.09|||t-test, 2 sided|||||0.09|-0.42|.199
91593595|NCT05470465|183077579|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|ONE_SIDED|97.5||-3.1||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.1||<0.001
91593596|NCT05470465|183077579|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.001|ONE_SIDED|97.5||-2.1||To demonstrate an effect of oxycodone with escitalopram compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.001
91593597|NCT05470465|183077580|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.002|ONE_SIDED|97.5||-2.1||To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.002
91613974|NCT02759146|183121783|SUPERIORITY||Least Square (LS) Mean|0.92||||0.17|TWO_SIDED|95.0|-8.62|1.52|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||1.52|-8.62|0.17
91613975|NCT02759146|183121783|SUPERIORITY||Least Square (LS) Mean|-4.48||||0.09|TWO_SIDED|95.0|-9.66|0.7|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.70|-9.66|0.09
91593598|NCT05470465|183077580|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.5||To demonstrate an effect of escitalopram compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.5||0.003
91593599|NCT05470465|183077581|SUPERIORITY||Mean Difference (Final Values)|-7.1|||<|0.001|ONE_SIDED|97.5||-4.1||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-4.1||<0.001
91593600|NCT05470465|183077581|SUPERIORITY||Mean Difference (Final Values)|-5.6|||<|0.001|ONE_SIDED|97.5||-2.6||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.6||<0.001
91593601|NCT05470465|183077582|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.001|ONE_SIDED|97.5||-5.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-5.9||<0.001
91593602|NCT05470465|183077582|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.7||0.003
91593603|NCT05470465|183077583|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|ONE_SIDED|97.5||-6.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.5||<0.001
91613976|NCT00385268|183121793|SUPERIORITY||Odds Ratio (OR)|1.68||||0.44|TWO_SIDED|95.0|0.55|5.14|||GEE model of repeated measures|GEE on repeated binary indicators of BE positive / negative test||||5.14|0.55|0.44
91613977|NCT01525849|183121832|NON_INFERIORITY_OR_EQUIVALENCE|Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.|||||<|0.001|||||||t-test, 1 sided|||Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.||||<0.001
91613978|NCT01525849|183121833|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.||||<0.0001
91613979|NCT01525849|183121834|SUPERIORITY_OR_OTHER|||||||0.628|||||||t-test, 2 sided|||||||0.628
91593604|NCT05470465|183077583|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|ONE_SIDED|97.5||-9.0||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-9.0||<0.001
91593605|NCT05470465|183077584|SUPERIORITY||Mean Difference (Final Values)|-14.1|||<|0.001|ONE_SIDED|97.5||-8.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-8.5||<0.001
91593606|NCT05470465|183077584|SUPERIORITY||Mean Difference (Final Values)|-9.5|||<|0.001|ONE_SIDED|97.5||-3.8||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.8||<0.001
91593607|NCT00449670|183077629|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.81||||||95.0|0.66|1.01|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 2).||1.01|0.66|
91593608|NCT00449670|183077629|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.69|1.06|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 3).||1.06|0.69|
91593609|NCT00449670|183077629|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.68|1.05|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 4).||1.05|0.68|
91648719|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|3.0||0.7758|TWO_SIDED|95.0|-5.31|7.03|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.03|-5.31|0.7758
91593610|NCT00449670|183077629|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.05|||||TWO_SIDED|95.0|0.85|1.3|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 3).||1.3|0.85|
91593611|NCT00449670|183077629|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 4).||1.29|0.84|
91613980|NCT01525849|183121836|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91782892|NCT00478023|183445539|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|51.4|||<|0.0001||95.0|36.1|66.7||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA||Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||66.7|36.1|<0.0001
91790330|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|0.39|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91593612|NCT00449670|183077629|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.23|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 3 and Lot 4).||1.23|0.8|
91593613|NCT03577730|183077711|OTHER||Median Difference (Final Values)|55.0||||0.092|TWO_SIDED|95.0|-9.0|118.0|||Generalized estimating equations||The median difference (+55) is an estimated difference between groups - rather than the actual difference - based on the pre-specified generalized estimated equations modeling.|||118|-9|0.092
91593614|NCT03577730|183077712|OTHER|||||||0.802|||||||Mixed Models Analysis|||Analysis for visual analog scale scores at rest presented.||||0.802
91593615|NCT03577730|183077713|OTHER|||||||0.32|||||||Mixed Models Analysis|||||||0.320
91593616|NCT03577730|183077714|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.670
91593617|NCT03577730|183077715|OTHER|||||||0.595|||||||Fisher Exact|||||||0.595
91593618|NCT03577730|183077716|OTHER|||||||0.985|||||||Fisher Exact|||||||0.985
91593619|NCT03577730|183077717|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||||||0.417
91593620|NCT03577730|183077718|OTHER|||||||0.432|||||||Wilcoxon (Mann-Whitney)|||||||0.432
91709212|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.804|TWO_SIDED|95.0|0.64|1.41|||Poission regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.41|0.64|0.804
91593621|NCT03577730|183077719|OTHER|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
91593622|NCT03577730|183077720|OTHER|||||||0.058|||||||Chi-squared|||||||0.058
91593623|NCT06098248|183077762|NON_INFERIORITY|The non-inferiority margin was set at 0.05 for sensitivity. A power calculation was conducted assuming a 30% missing data rate, with final missing data at approximately 10%|Risk Difference (RD)|-0.0123|STANDARD_ERROR_OF_MEAN|0.0132|<|0.4049|ONE_SIDED|95.0||0.0164||A one-sided significance level of 0.05 was used for the non-inferiority tests.|McNemar|McNemar's test was chosen due to paired nominal data (specimens tested by both methods). Degrees of freedom = 1|Lower Limit reflects estimated value due to 1-sided CI requirement and system constraints. True lower bound is theoretically -∞.|We performed a paired comparison within the same participant population, evaluating both cCeLL - Ex vivo and Frozen Section on each specimen.|If any secondary analyses could not fit into the above format (e.g., AUC analysis, time efficiency), they were reported as descriptive statistics rather than hypothesis testing|0.0164||<0.4049
91593624|NCT06098248|183077763|NON_INFERIORITY|The non-inferiority margin was set at 0.10 for specificity|Risk Difference (RD)|-0.1071|STANDARD_DEVIATION|0.4103|<|0.3075|TWO_SIDED|95.0|-0.1628|0.0557||A one-sided significance level of 0.10 was used for the non-inferiority tests.|McNemar|McNemar's test was chosen due to paired nominal data (specimens tested by both methods). Degrees of freedom = 1|Lower Limit reflects estimated value due to 1-sided CI requirement and system constraints. True lower bound is theoretically -∞.|We performed a paired comparison within the same participant population, evaluating both cCeLL - Ex vivo and Frozen Section on each specimen.|f any secondary analyses could not fit into the above format (e.g., AUC analysis, time efficiency), they were reported as descriptive statistics rather than hypothesis testing|0.0557|-0.1628|<0.3075
91709213|NCT01402986|183311363|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.088|TWO_SIDED|95.0|0.47|1.05|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.05|0.47|0.088
91782893|NCT00478023|183445539|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|46.9|||<|0.0001||95.0|31.4|62.4||No multiplicity adjustment.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as a covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||62.4|31.4|<0.0001
91521879|NCT05614089|182918418|SUPERIORITY|||||||0.1|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||12-month||||0.10
91790331|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.052||0.595|TWO_SIDED|95.0|-0.075|0.131||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.131|-0.075|0.595
91790332|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790333|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.054||0.201|TWO_SIDED|95.0|0.037|0.175||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.175|0.037|0.201
91790334|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790335|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.064||0.361|TWO_SIDED|95.0|-0.067|0.184||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.184|-0.067|0.361
91790336|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790337|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.522|TWO_SIDED|95.0|-0.082|0.162||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|Week 48||0.162|-0.082|0.522
91790338|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790339|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.064||0.147|TWO_SIDED|95.0|-0.033|0.219||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.219|-0.033|0.147
91790340|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790341|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.492|TWO_SIDED|95.0|-0.243|0.117||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.117|-0.243|0.492
91790342|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790343|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.691|TWO_SIDED|95.0|-0.213|0.141||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.141|-0.213|0.691
91790344|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790345|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.091||0.135|TWO_SIDED|95.0|-0.043|0.317||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.317|-0.043|0.135
91790346|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790347|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.117||0.713|TWO_SIDED|95.0|-0.273|0.187||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.187|-0.273|0.713
91790348|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790349|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.318|TWO_SIDED|95.0|-0.341|0.111||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.111|-0.341|0.318
91593625|NCT00253643|183077764|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED|||||Utilized a priori threshold for statistical significance of 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores||||0.1521
91593626|NCT00253643|183077765|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|||||A priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67||||0.1573
91593627|NCT02445651|183077772|OTHER|Correlation coefficient: The correlation between the pre-to-post change in UPDRS and the imaging findings of DAT binding in the caudate and putamen, as well as SERT binding in the midbrain, was evaluated using both Pearson and Spearman correlation coefficients to confirm any findings using both methods. Analysis of UPDRS total scores, pre-to post differences were compared between NAC and controls study groups using 2-sample t-test.||||||0.05||||||P value adjusted for multiple comparisons. Threshold, for a 5-10% improvement in oral and IV NAC cohort for an 80% power to detect a significant change of P = 0.05. for sample size \~ 28 subjects in the NAC arm and \~ 14 subjects in the control arm.|5-10% improvement in the oral and IV NAC|Threshold, for a 5-10% improvement in oral and IV NAC cohort for an 80% power to detect a significant change of P = 0.05.|||The primary analysis of dopamine and midbrain serotonin uptake measures from DaTscan was performed using separate linear mixed effect (LME) models with random subject effect. This method differs from a repeated measures analysis of variance because the LME is a statistical model that has both fixed effects and random effects.|||0.05
91593628|NCT02445651|183077772|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91593629|NCT02445651|183077772|OTHER|The primary analysis of dopamine and midbrain serotonin uptake measures from DaTscan was performed using separate linear mixed effect (LME) models with random subject effect. This method differs from a repeated measures analysis of variance because the LME is a statistical model that has both fixed effects and random effects.||||||0.05||||||For a 5-10% improvement in the oral and IV NAC cohort for an 80% power to detect a significant change of P = 0.05. for sample size \~ 28 subjects in the NAC arm and \~ 14 subjects in the control arm.|t-test, 2 sided|Correlation coefficient: pre-to-post evaluated using Pearson and Spearman correlation coefficients to confirm any findings.||||||0.05
91593630|NCT03596866|183077776|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.8672|TWO_SIDED|95.0|0.658|1.424||P-value from a 2-sided stratified log-rank test using the stratification factors: presence of intracranial central nervous system (CNS) metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|2-sided Stratified Log-rank Test||The hazard ratio was obtained using the stratified Cox regression model with the same stratification factors.|||1.424|0.658|=0.8672
91593631|NCT03596866|183077777|SUPERIORITY||Hazard Ratio (HR)|1.592|||=|0.0713|TWO_SIDED|95.0|0.956|2.652||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||2.652|0.956|=0.0713
91782894|NCT00611026|183445571|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||<0.0001
91782895|NCT00611026|183445571|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0228
91782896|NCT00611026|183445571|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0072
91782897|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0020
91593632|NCT03596866|183077778|SUPERIORITY||Hazard Ratio (HR)|1.232|||=|0.2501|TWO_SIDED|95.0|0.862|1.761||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||1.761|0.862|=0.2501
91593633|NCT03596866|183077779|SUPERIORITY||Odds Ratio (OR)|0.7|||=|0.1555|TWO_SIDED|95.0|0.42|1.15||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|BIRC Assessed||1.15|0.42|=0.1555
91593634|NCT03596866|183077779|SUPERIORITY||Odds Ratio (OR)|0.55|||=|0.0169|TWO_SIDED|95.0|0.33|0.9||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Investigator Assessed||0.90|0.33|=0.0169
91593635|NCT03596866|183077782|SUPERIORITY||Odds Ratio (OR)|1.31|||=|0.6246|TWO_SIDED|95.0|0.44|3.84||P-value was from a Cochran-Mantel-Haenszel test stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|Cochran-Mantel-Haenszel||Odds ratio was stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|||3.84|0.44|=0.6246
91593636|NCT03596866|183077784|SUPERIORITY||||||=|0.0778||||||P-value from a 2-sided stratified Gray's test using the stratification factors (at randomization per IxRS): presence of intracranial CNS metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|Gray's Test|P-value is for the event type: Intracranial Disease Progression without Prior Systemic Progression or Death.||||||=0.0778
91593637|NCT04770532|183077787|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||-0.08|-0.37|<0.0001
91593638|NCT04707157|183077815|SUPERIORITY||Posterior Mean Difference|-1.56|||||TWO_SIDED|95.0|-2.76|-0.38|||||Posterior mean difference with 95% credible interval is reported.|||-0.38|-2.76|
91593639|NCT04707157|183077816|SUPERIORITY||Posterior Mean Difference|-1.03|||||TWO_SIDED|95.0|-2.14|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-2.14|
91593640|NCT04707157|183077817|SUPERIORITY||Posterior Mean Difference|-0.91|||||TWO_SIDED|95.0|-1.56|-0.25|||||Posterior mean difference with 95% credible interval is reported.|||-0.25|-1.56|
91593641|NCT04707157|183077818|SUPERIORITY||Posterior Mean Difference|-1.99|||||TWO_SIDED|95.0|-3.22|-0.77|||||Posterior mean difference with 95% credible interval is reported.|||-0.77|-3.22|
91593642|NCT04707157|183077819|SUPERIORITY||Posterior Mean Difference|-19.12|||||TWO_SIDED|95.0|-31.22|-6.97|||||Posterior mean difference with 95% credible interval is reported.|||-6.97|-31.22|
91593643|NCT04707157|183077820|SUPERIORITY||Posterior Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.86|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.86|
91593644|NCT04707157|183077821|SUPERIORITY||Posterior Mean Difference|-269.92|||||TWO_SIDED|95.0|-624.98|86.24|||||Posterior mean difference with 95% credible interval is reported.|||86.24|-624.98|
91593645|NCT04707157|183077822|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.22|0.29|||||Posterior mean difference with 95% credible interval is reported.|||0.29|-0.22|
91593646|NCT01748942|183077861|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91593647|NCT01748942|183077864|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91782898|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.0519|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0519
91782899|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.1503|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1503
91782900|NCT00611026|183445572|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91593648|NCT01748942|183077865|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91593649|NCT01748942|183077866|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91593650|NCT01748942|183077867|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91593651|NCT01748942|183077868|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
91593652|NCT03437564|183077869|EQUIVALENCE|The difference in the least square (LS) means between the formulations (dosing of one Vortioxetine 20 mg tablet - dosing of two Vortioxetine 10 mg tablets) and the two-sided 90% confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.996|||||TWO_SIDED|90.0|0.967|1.026|||ANOVA|||||1.026|0.967|
91593653|NCT03437564|183077870|EQUIVALENCE|The difference in the LS means between the formulations (dosing of one vortioxetine 20 mg tablet - dosing of two vortioxetine 10 mg tablets) and the two-sided 90% CI were provided using a crossover ANOVA model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.972|||||TWO_SIDED|90.0|0.937|1.008|||ANOVA|||||1.008|0.937|
91593654|NCT00243386|183077881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6016||95.0|||||t-test, 2 sided|||A t-test was used to compare the means of the transformed data. The null-hypothesis tested was H0: X'A(PK-driven prophylaxis) - X'B (standard prophylaxis) = 0 (i.e., no difference for treatment under the 2 prophylactic regimens. X' = (ABR+0.5)\^(1/2)||||0.6016
91593655|NCT00243386|183077882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-Test|||||||<0.0001
91593656|NCT00243386|183077883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
91593657|NCT00243386|183077884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
91593658|NCT00243386|183077885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4924||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.4924
91593659|NCT00243386|183077906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1467||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.1467
91593660|NCT00243386|183077907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0007
91593661|NCT00243386|183077908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0002
91593662|NCT00243386|183077909|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Signed-Rank Test|||||||<0.0001
91593663|NCT04995055|183077917|SUPERIORITY||Least-square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|2.81|||TWO_SIDED|95.0|-21.2|-9.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-9.5|-21.2|
91593664|NCT04995055|183077918|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
91593665|NCT04995055|183077919|SUPERIORITY||Least-square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-4.9|-2.1|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-2.1|-4.9|
91593666|NCT04995055|183077920|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
91593667|NCT04995055|183077922|SUPERIORITY||Least-square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-4.4|-1.9|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-1.9|-4.4|
91593668|NCT03418129|183077923|SUPERIORITY||Slope|0.2331|STANDARD_ERROR_OF_MEAN|0.2176||0.2852|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.2852
91593669|NCT03418129|183077923|SUPERIORITY||Slope|0.03057|STANDARD_ERROR_OF_MEAN|0.2132||0.8861|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.8861
91593670|NCT03418129|183077924|SUPERIORITY||Slope|-0.03844|STANDARD_ERROR_OF_MEAN|0.09424||0.6842|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.6842
91593671|NCT03418129|183077924|SUPERIORITY||Slope|-0.1432|STANDARD_ERROR_OF_MEAN|0.09427||0.132|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.132
91593672|NCT03418129|183077925|SUPERIORITY||Slope|0.1911|STANDARD_ERROR_OF_MEAN|0.2551||0.4542|TWO_SIDED||||||ANCOVA|||||||0.4542
91593673|NCT03418129|183077925|SUPERIORITY||Slope|-0.3761|STANDARD_ERROR_OF_MEAN|0.2454||0.1261|TWO_SIDED||||||ANCOVA|||||||0.1261
91593674|NCT01940471|183077943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 288 and 576 participants in the TDF and TAF groups, respectively, were planned to give 84% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size based on the assumption that the expected difference (TAF - TDF) in the proportion of participants with HBV DNA \< 29 IU/mL was 0 and the proportion of participants with HBV DNA \< 29 IU/mL in the TDF group was 69%. Missing data were treated as not achieving the primary endpoint.|Difference in proportions|-3.6|||||TWO_SIDED|95.0|-9.8|2.6|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||2.6|-9.8|
91593675|NCT01806857|183077967|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Random Effects Model|||||||0.0003
91593676|NCT01806857|183077971|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Random Effects Model|||||||0.0001
91593677|NCT01721057|183077983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Regression, Logistic|||||||0.001
91593678|NCT01202279|183078004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Fisher Exact|||||||0.025
91593679|NCT01202279|183078005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANCOVA|||||||0.022
91593680|NCT00789880|183078030|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.||||0.7
91593681|NCT00789880|183078030|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.12
91593682|NCT00789880|183078031|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.3
91593683|NCT00789880|183078032|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
91521880|NCT05417620|182918419|OTHER||Incidence rate ratio|1.21||||0.707|TWO_SIDED|95.0|0.44|3.31||Threshold for significance: 0.05.|Regression, Poisson|||"This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report rate = average counts of PrEP initiations per number of study months."||3.31|0.44|0.707
91521881|NCT03937219|182918430|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0131|TWO_SIDED|95.0|0.57|0.94|||Log Rank|||||0.94|0.57|0.0131
91593684|NCT00789880|183078032|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.2
91593685|NCT00789880|183078033|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.8
91593686|NCT00789880|183078033|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.2
91593687|NCT00789880|183078034|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.4
91593688|NCT00789880|183078035|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
91593689|NCT00789880|183078035|SUPERIORITY_OR_OTHER|||||||1||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||1.0
91593690|NCT00789880|183078036|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.2
91593691|NCT00789880|183078036|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.5
91593692|NCT00789880|183078037|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.7
91593693|NCT00789880|183078038|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.2
91593694|NCT00789880|183078038|SUPERIORITY_OR_OTHER|||||||0.3||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.3
91593695|NCT03159091|183078061|SUPERIORITY|||||||0.0422|||||||G-test (Chi-square)|||||||0.0422
91593696|NCT03159091|183078062|SUPERIORITY|||||||0.1101|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between initial and 4 weeks total scores row.||||0.1101
91648720|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|2.45||0.888|TWO_SIDED|95.0|-5.4|4.71|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||4.71|-5.40|0.8880
91593697|NCT03159091|183078063|SUPERIORITY|||||||0.1373|||||||G-test (Chi-square)|||||||0.1373
91593698|NCT03159091|183078064|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|||||||0.0870
91593699|NCT03159091|183078065|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91593700|NCT02044133|183078081|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91593701|NCT04085523|183078082|SUPERIORITY||||||=|0.6004|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.6004
91593702|NCT04085523|183078082|SUPERIORITY||||||=|0.7022|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.7022
91593703|NCT04085523|183078082|SUPERIORITY||||||=|0.0849|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0849
91593704|NCT04085523|183078082|SUPERIORITY||||||=|0.0218|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0218
91593705|NCT02046096|183078083|OTHER||12-month rate (%)|97.8|||<|0.0001|TWO_SIDED|95.0|95.6|99.1||The threshold for statistical significance was p = 0.025|One-tailed Exact binomial test||The 95% confidence interval was computed using Exact method.|Null Hypothesis: The rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling, π, does not meet the performance goal (90%).||99.1|95.6|<0.0001
91593706|NCT02046096|183078084|OTHER||Cumulative probability|81.5|STANDARD_ERROR_OF_MEAN|4.5||0.369|TWO_SIDED|95.0|72.6|90.4||the threshold for statistical significance is 0.025.|Z-statistic|The hypothesis is assessed using a Z-statistic. The Z-statistic is given by Z = (Ŝ(t) - 0.8) / SE where SE is the Standard Error|The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|"the null hypotheses is: H0: S(t) ≤ 80%(Performance Goal) where,~* t is time through 12 months~* S(t) is the true rate of freedom from major adverse events at time t."||90.4|72.6|0.369
91593707|NCT02046096|183078085|OTHER||12-month freedom from MAE rate (%)|86.7||||0.001|TWO_SIDED|95.0|82.5|90.2||The threshold for statistical significance was p = 0.025|One-tailed exact binomial test|||Null Hypothesis: The 12-month freedom from MAE, π, does not meet the performance goal (80%).||90.2|82.5|0.001
91593708|NCT00487396|183078098|OTHER||||||<|0.0001|||||||McNemar|||"Pathologies were including in the analysis as follows:~* combination of CE+IC procedures but not detected by the combination of SBFT+IC procedures were marked as CE+IC new finding ;~* Pathologies detected by the combination of SBFT+IC procedures but not detected by the combination of CE+IC procedures were marked as SBFT+IC new finding event;~* Pathologies detected by the combination of CE+IC procedures and by the combination of SBFT+IC procedures were marked as same findings event."||||<0.0001
91593709|NCT00487396|183078099|OTHER||||||<|0.0001|||||||McNemar|||"For each category, the numbers of found and missed pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by SBFT procedure were marked as CE new finding event;~* Pathologies detected by SBFT procedure but not detected by CE procedure were marked as SBFT new finding event;~* Pathologies detected by both procedures (i.e., CE and SBFT) were marked as same findings event."||||<0.0001
91593710|NCT00487396|183078100|OTHER|||||||0.085|||||||McNemar|||"Pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by IC procedure were marked as CE new finding event;~* Pathologies detected by IC procedure but not detected by CE procedure were marked as IC new finding event;~* Pathologies detected by both procedures (i.e., CE and IC) were marked as same findings event."||||0.085
91593711|NCT00943579|183078122|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||Chi-square analyses were used to assess CGI-I scores. there were no transformations.||||>.05
91593712|NCT00418665|183078131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||||95.0|0.07|5.136|||||Romiplostim/placebo|||5.136|0.070|
91593713|NCT00418665|183078131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
91593714|NCT00418665|183078132|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
91593715|NCT00418665|183078132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.514||||||95.0|0.102|2.589|||||Romiplostim/placebo|||2.589|0.102|
91593716|NCT00418665|183078133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||||95.0|0.227|39.608|||||Romiplostim/placebo|||39.608|0.227|
91593717|NCT00418665|183078133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.714||||||95.0|0.144|20.473|||||Romiplostim/placebo|||20.473|0.144|
91593718|NCT00418665|183078134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||||95.0|0.097|8.529|||||Romiplostim/placebo|||8.529|0.097|
91593719|NCT00418665|183078134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.866||||||95.0|0.175|4.278|||||Romiplostim/placebo|||4.278|0.175|
91593720|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 4||14.2|-5.0|
91593721|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 6B||9.5|-7.3|
91648721|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|1.86|STANDARD_ERROR_OF_MEAN|2.46||0.4573|TWO_SIDED|95.0|-3.21|6.93|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||6.93|-3.21|0.4573
91648722|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|2.78||0.4424|TWO_SIDED|95.0|-3.56|7.91|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.91|-3.56|0.4424
91782901|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0002
91782902|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Van Elteren's|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0130
91782903|NCT00611026|183445572|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91782904|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0021
91782905|NCT00611026|183445572|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0525
91782906|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0161|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||-0.1|-0.5|0.0161
91782907|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0944|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.4|0.0944
91593722|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 9V||9.5|-7.3|
91593723|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.8|9.5||||||Comparison between treatments for common serotype 14||9.5|-7.8|
91593724|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 18C||14.2|-5.0|
91593725|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 19F||9.5|-7.3|
91593726|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 23F||9.5|-7.3|
91593727|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
91648723|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|3.32||0.347|TWO_SIDED|95.0|-3.65|10.01|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||10.01|-3.65|0.3470
91648724|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|2.72||0.6249|TWO_SIDED|95.0|-4.25|6.94|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||6.94|-4.25|0.6249
91593728|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 3||9.5|-7.3|
91593729|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 5||9.5|-7.3|
91593730|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
91593731|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 7F||9.5|-7.3|
91593732|NCT00853749|183078135|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
91593733|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.8|||||TWO_SIDED|95.0|-8.6|12.7||||||Comparison between treatments for common serotype 4||12.7|-8.6|
91593734|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 6B||9.7|-7.5|
91593735|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 9V||9.7|-7.5|
91648725|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|2.73||0.1625|TWO_SIDED|95.0|-1.69|9.54|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||9.54|-1.69|0.1625
91593736|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 14||9.7|-7.5|
91593737|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.4|10.0||||||Comparison between treatments for common serotype 18C||10.0|-7.4|
91593738|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|10.0||||||Comparison between treatments for common serotype 19F||10.0|-7.5|
91593739|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-10.8|8.1||||||Comparison between treatments for common serotype 23F||8.1|-10.8|
91593740|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
91593741|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.1|7.9||||||Comparison between treatments for additional serotype 3||7.9|-11.1|
91593742|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.7|||||TWO_SIDED|95.0|-8.5|12.2||||||Comparison between treatments for additional serotype 5||12.2|-8.5|
91593743|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
91593744|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.3|7.7||||||Comparison between treatments for additional serotype 7F||7.7|-11.3|
91648726|NCT00272961|183190171|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|3.08||0.7556|TWO_SIDED|95.0|-5.38|7.31|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||7.31|-5.38|0.7556
91593745|NCT00853749|183078136|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
91593746|NCT00853749|183078137|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.3|||||TWO_SIDED|95.0|0.22|0.42|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.42|0.22|
91593747|NCT00853749|183078137|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.32|||||TWO_SIDED|95.0|0.23|0.44|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.44|0.23|
91593748|NCT00853749|183078137|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.44|||||TWO_SIDED|95.0|0.29|0.67|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.67|0.29|
91593749|NCT00853749|183078137|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.61|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.61|
91790350|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790351|NCT02880956|183460060|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.119||0.927|TWO_SIDED|95.0|-0.244|0.222||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.222|-0.244|0.927
91593750|NCT00853749|183078137|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.47|||||TWO_SIDED|95.0|0.34|0.65|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.65|0.34|
91593751|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.35|1.12|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.12|0.35|
91593752|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.68|1.38|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.38|0.68|
91593753|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.51|1.81|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.81|0.51|
91593754|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.67|1.48|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.48|0.67|
91593755|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.33|0.98|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.98|0.33|
91593756|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.72|1.56|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.56|0.72|
91593757|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.39|0.99|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.99|0.39|
91593758|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.2|||||TWO_SIDED|95.0|0.12|0.32|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.32|0.12|
91593759|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.56|1.18|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.18|0.56|
91593760|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.4|||||TWO_SIDED|95.0|0.21|0.63|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.63|0.21|
91593761|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.88|2.25|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||2.25|0.88|
91593762|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.7|||||TWO_SIDED|95.0|0.48|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.48|
91593763|NCT00853749|183078138|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.54|1.2|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.20|0.54|
91593764|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.37|||||TWO_SIDED|95.0|0.25|0.55|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.55|0.25|
91593765|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.71|||||TWO_SIDED|95.0|0.44|1.15|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.15|0.44|
91593766|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.75|0.45|
91593767|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.48|1.24|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.24|0.48|
91521882|NCT04393441|182918432|NON_INFERIORITY|MMRM with fixed effects=treatment, visit, visit by treatment interaction,Baseline total staining stratum(TSS),and Baseline TSS by visit interaction.|Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.57||0.0475|TWO_SIDED|95.0|0.01|2.27|||MMRM|||Change from Baseline in Total Staining Score at Day 90: The null hypothesis was that 011516X tear formulation was to be considered noninferior to Systane Ultra MD if the upper limit of 2-sided confidence interval (CI) was less than 2.3 units.||2.27|0.01|0.0475
91521883|NCT04393441|182918433|OTHER|No formal hypothesis was planned. The p-value for treatment differences is reported for reference.|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|16.32||0.9001|TWO_SIDED|95.0|-30.03|34.14|||MMRM|MMRM with fixed effects=treatment, visit, visit by treatment interaction, Baseline TSS, and Baseline TSS by visit interaction.||||34.14|-30.03|0.9001
91521884|NCT02782169|182918434|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
91521885|NCT02953938|182918470|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_DEVIATION|0.64||0.368|TWO_SIDED|95.0|-1.49|1.07|||Cochran-Mantel-Haenszel|||||1.07|-1.49|0.3680
91593768|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.57|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.85|0.38|
91593769|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.56|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.56|
91593770|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.64|||||TWO_SIDED|95.0|0.44|0.95|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.95|0.44|
91593771|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.27|||||TWO_SIDED|95.0|0.18|0.4|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.40|0.18|
91593772|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.76|1.72|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.72|0.76|
91593773|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.36|||||TWO_SIDED|95.0|0.25|0.51|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.51|0.25|
91593774|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.55|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.55|
91593775|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.61|1.28|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.28|0.61|
91593776|NCT00853749|183078139|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.6|1.23|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.23|0.60|
91593777|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any tenderness||||0.253
91593778|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for significant tenderness||||0.380
91593779|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.135|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any redness||||0.135
91593780|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild redness||||0.520
91593781|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate redness||||0.283
91782908|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3613|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.3|0.3613
91782909|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.4|-0.9|<0.0001
91782910|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0043|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.1|-0.6|0.0043
91782911|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0186|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||-0.0|-0.5|0.0186
91790352|NCT02880956|183460060|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91782912|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.4|-0.9|<0.0001
91782913|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0407|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-0.6|0.0407
91782914|NCT00611026|183445573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0016|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||-0.1|-0.6|0.0016
91782915|NCT00611026|183445574|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0217
91648727|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.59||0.0714|TWO_SIDED|95.0|-6.25|0.28|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||0.28|-6.25|0.0714
91521886|NCT02953938|182918471|SUPERIORITY||Mean Difference (Final Values)|-6.58|STANDARD_DEVIATION|3.042||0.0349|TWO_SIDED|95.0|-12.67|-0.48|||ANOVA|||||-0.48|-12.67|0.0349
91521887|NCT02953938|182918472|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.051||0.2707|TWO_SIDED|95.0|-0.045|0.158|||ANOVA|||||0.158|-0.045|0.2707
91521888|NCT02953938|182918474|SUPERIORITY||Mean Difference (Final Values)|11.32||||0.7602|TWO_SIDED|95.0|-62.65|85.28|||ANOVA|||||85.28|-62.65|0.7602
91521889|NCT03371082|182918479|EQUIVALENCE|The limits of the lower and upper equivalence margin were -11.3 and 11.3, respectively.|Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|90.0|-5.4|6.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||6.5|-5.4|
91648728|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.34||0.7269|TWO_SIDED|95.0|-2.29|3.24|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.24|-2.29|0.7269
91782916|NCT00611026|183445574|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
91782917|NCT00611026|183445574|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0020
91782918|NCT00611026|183445574|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0217
91782919|NCT00611026|183445574|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
91782920|NCT00611026|183445574|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0421
91782921|NCT00611026|183445574|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0023
91782922|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.3823|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||0.1|-0.1|0.3823
91782923|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.4802|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.1|-0.1|0.4802
91782924|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.8355|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.1|0.8355
91782925|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.0286|TWO_SIDED|95.0|-0.12|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.0|-0.12|0.0286
91521890|NCT00810264|182918560|NON_INFERIORITY|The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.|||||<|0.0001|||||||Binomial Proportion|||||||<0.0001
91521891|NCT01648348|182918632|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.57|TWO_SIDED|95.0|0.73|1.77|||Log Rank|||||1.77|0.73|0.57
91521892|NCT01648348|182918633|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91521893|NCT01648348|182918634|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.82|TWO_SIDED|95.0|0.66|1.69|||Log Rank|||||1.69|0.66|0.82
91521894|NCT01648348|182918636|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
91521895|NCT01648348|182918637|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Future uncertainty symptom scale/item t-test, 2-sided, unpooled.||||0.55
91521896|NCT01648348|182918637|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Visual disorder symptom scale/item t-test, 2-sided, unpooled.||||0.16
91521897|NCT01648348|182918637|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Motor dysfunction symptom scale/item t-test, 2-sided, unpooled.||||0.99
91521898|NCT01648348|182918637|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Communication deficit symptom scale/item t-test, 2-sided, unpooled.||||0.75
91521899|NCT01648348|182918637|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Headaches symptom scale/item t-test, 2-sided, unpooled.||||0.17
91521900|NCT01648348|182918637|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Seizures symptom scale/item t-test, 2-sided, unpooled.||||0.90
91521901|NCT01648348|182918637|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Drowsiness symptom scale/item t-test, 2-sided, unpooled.||||0.82
91521902|NCT01648348|182918637|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Itchy skin symptom scale/item t-test, 2-sided, unpooled.||||0.15
91521903|NCT01648348|182918637|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Hair loss symptom scale/item t-test, 2-sided, unpooled.||||0.77
91521904|NCT01648348|182918637|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Weakness of legs symptom scale/item t-test, 2-sided, unpooled.||||0.10
91521905|NCT01648348|182918637|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Bladder control symptom scale/item t-test, 2-sided, unpooled.||||0.65
91521906|NCT01648348|182918638|SUPERIORITY|||||||0.83|||||||proportion test|||||||0.83
91521907|NCT00696410|182918642|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||p value represents test of paired (within patient) difference||||0.068
91521908|NCT00696410|182918642|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.022
91521909|NCT00696410|182918643|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Sign test|||p value represents test of paired (within patient) difference||||0.71
91521910|NCT00696410|182918643|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.33
91521911|NCT00696410|182918644|SUPERIORITY_OR_OTHER|||||||0.69|||||||Sign test|||p value represents test of paired (within patient) difference||||0.69
91521912|NCT00696410|182918644|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.004
91521913|NCT00696410|182918645|SUPERIORITY_OR_OTHER|||||||0.48|||||||Sign test|||p value represents test of paired (within patient) difference||||0.48
91521914|NCT00696410|182918645|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.39
91521915|NCT00696410|182918646|SUPERIORITY_OR_OTHER|||||||0.92|||||||Sign test|||p value represents test of paired (within patient) difference||||0.92
91521916|NCT00696410|182918646|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.22
91521917|NCT03063294|182918647|SUPERIORITY||Difference in Difference|0.02|||||TWO_SIDED|95.0|-0.47|0.5|||||"The difference in difference equals the follow-up minus baseline change in Hassles scale results for the toolkit plus coaching clinics, minus the follow-up minus baseline change in the Hassles scale results for the toolkit only clinics."|"Zero-inflated negative binomial regression was used to obtain predicted mean Hassles scale scores for the toolkit only clinics and toolkit plus coaching clinics at baseline and follow-up, adjusting for study design and characteristics of survey respondents. The difference-in-difference was then computed as described below, under method of estimation. Bootstrap resampling was used to calculate the 95% confidence intervals around the predicted means and the difference-in-difference."||0.50|-0.47|
91521918|NCT02134587|182918655|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.00001
91521919|NCT02134587|182918656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91521920|NCT01165775|182918744|SUPERIORITY_OR_OTHER|||||||0.2155|||||||Chi-squared|||||||0.2155
91521921|NCT03355326|182918745|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
91521922|NCT03355326|182918746|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.900
91521923|NCT03355326|182918747|SUPERIORITY|||||||0.648|||||||Wilcoxon (Mann-Whitney)|||||||0.648
91521924|NCT03355326|182918748|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||||||0.967
91521925|NCT03355326|182918749|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91521926|NCT03355326|182918750|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91521927|NCT03355326|182918751|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91521928|NCT00608582|182918756|SUPERIORITY_OR_OTHER||||||<|0.028||||||p\<0.05 considered significant|ANOVA|Post-hoc paired t-tests were performed.||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).||||<0.028
91521929|NCT00608582|182918756|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.||||<0.05
91593782|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.225|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe redness||||0.225
91593783|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any swelling||||0.202
91593784|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild swelling||||0.294
91782926|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0794|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||0.0|-0.2|0.0794
91593785|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate swelling||||0.175
91593786|NCT00853749|183078140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.314|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe swelling||||0.314
91593787|NCT00853749|183078141|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C||||> .99
91593788|NCT00853749|183078141|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased appetite||||> .99
91593789|NCT00853749|183078141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.543|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for irritability||||0.543
91782927|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.0||0.5906|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||0.1|-0.1|0.5906
91593790|NCT00853749|183078141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.233|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for increased sleep||||0.233
91593791|NCT00853749|183078141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased sleep||||0.198
91593792|NCT00853749|183078141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.628|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for rash||||0.628
91593793|NCT01538628|183078144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Exact binomial test|testing the null hypothesis that the proportion for SpaceOAR is less than or equal to 0.70.||||||.0001
91782928|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0134|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.0|-0.3|0.0134
91782929|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.1759|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.2|0.1759
91782930|NCT00611026|183445575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.0||0.1661|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||0.0|-0.2|0.1661
91782931|NCT00611026|183445576|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0021
91782932|NCT00611026|183445576|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0200
91593794|NCT00307151|183078151|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.6||||0.015|TWO_SIDED|95.0|3.7|33.6||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months)and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||33.6|3.7|0.015
91593795|NCT00307151|183078151|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.5|||<|0.001|TWO_SIDED|95.0|11.2|31.8||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months) and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||31.8|11.2|<0.001
91593796|NCT01761292|183078226|OTHER||mean|13.906|||<|0.0001|TWO_SIDED|95.0|11.5657|16.2466||The paired t-test or non-parametric signed rank test for 2 means (paired observations) (as is appropriate) was applied for testing the statistical significance of the Change From Baseline to End of Study. MFA% P \< 0.05 was set as significant.|t-test, 2 sided|||||16.2466|11.5657|<0.0001
91593797|NCT01761292|183078227|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
91593798|NCT05611671|183078241|OTHER||Risk Difference (RD)|6.71|||||TWO_SIDED|95.0|-7.76|21.18||||||||21.18|-7.76|
91782933|NCT00611026|183445577|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0006
91593799|NCT05611671|183078241|OTHER||Risk Difference (RD)|-0.41|||||TWO_SIDED|95.0|-13.99|13.17||||||||13.17|-13.99|
91593800|NCT05611671|183078241|OTHER||Risk Difference (RD)|-6.93|||||TWO_SIDED|95.0|-19.74|5.88||||||||5.88|-19.74|
91593801|NCT05611671|183078242|OTHER||Risk Difference (RD)|7.05|||||TWO_SIDED|95.0|-8.77|22.86||||||||22.86|-8.77|
91593802|NCT05611671|183078242|OTHER||Risk Difference (RD)|-0.93|||||TWO_SIDED|95.0|-16.74|14.88||||||||14.88|-16.74|
91782934|NCT00611026|183445577|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0202
91593803|NCT05611671|183078242|OTHER||Risk Difference (RD)|3.07|||||TWO_SIDED|95.0|-12.78|18.92||||||||18.92|-12.78|
91593804|NCT00309465|183078251|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value for three dosing strategies in insulin glargine only group in fasting blood glucose achievement of 100-179 mg/dl range.|Chi-squared|||Comparison for Target Blood Glucose Achievement of 100-179 mg/dl||||0.332
91593805|NCT00309465|183078251|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||P value is for three strategies in insulin glargine plus bolus group for fasting blood glucose achievement of 100-179 mg/dl|Chi-squared|||Comparison for Target Achievement of blood glucose values of 100-179 mg/dl||||0.294
91782935|NCT00611026|183445577|SUPERIORITY_OR_OTHER|||||||0.2126|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.2126
91593806|NCT00309465|183078251|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||P value is for three strategies in insulin glargine only group for achievement of 80-249 mg/dl|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl||||0.162
91593807|NCT00309465|183078251|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P value is for three strategies in insulin glargine plus bolus group in achievement of fasting blood glucose value of 80-249 mg/dl.|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl.||||0.031
91593808|NCT02113436|183078256|SUPERIORITY_OR_OTHER||Difference in Least square means|-0.97||||0.206|TWO_SIDED|95.0|-2.47|0.54|||ANCOVA|||||0.54|-2.47|0.206
91593809|NCT02113436|183078257|SUPERIORITY_OR_OTHER||Difference in Least sqaure means|-0.49||||0.235|TWO_SIDED|95.0|-1.29|0.32|||ANCOVA|||||0.32|-1.29|0.235
91593810|NCT02113436|183078258|SUPERIORITY_OR_OTHER||Difference in Least-Sqaure means|-0.48||||0.236|TWO_SIDED|95.0|-1.27|0.31|||ANCOVA|||||0.31|-1.27|0.236
91593811|NCT02113436|183078259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.14|1.6||||||||1.60|0.14|
91593812|NCT02113436|183078260|SUPERIORITY_OR_OTHER||Difference in Least-Square Means|0.7||||0.041|TWO_SIDED|95.0|0.0|1.4|||ANCOVA|||||1.4|0.0|0.041
91593813|NCT02113436|183078261|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.06||||0.335|TWO_SIDED|95.0|-0.2|0.07|||ANCOVA|||||0.07|-0.20|0.335
91593814|NCT02113436|183078262|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.6||||0.389|TWO_SIDED|95.0|-3.3|8.6|||ANCOVA|||||8.6|-3.3|0.389
91593815|NCT01486927|183078266|SUPERIORITY_OR_OTHER||Rate ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.07|0.1|||Poisson, regression|||A test of the null hypothesis of no difference on AsBR between the 2 comparison groups was based on the Poisson Regression method. The corresponding prophylaxis/on-demand ratio with 95% confidence interval (CI) was calculated.||0.10|0.07|< 0.0001
91593816|NCT02636582|183078290|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
91593817|NCT02636582|183078291|SUPERIORITY|||||||0.964|||||||Wilcoxon (Mann-Whitney)|||||||0.964
91593818|NCT02636582|183078292|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91593819|NCT02636582|183078293|OTHER|||||||0.172||||||HER2 expression - biopsy|Fisher Exact|||||||0.172
91593820|NCT02636582|183078293|OTHER|||||||0.38||||||HER2 expression - resection|Fisher Exact|||||||0.38
91593821|NCT05895552|183078305|SUPERIORITY|The mixed model repeated measures (MMRM) model includes treatment group, baseline NPRS score, visit, interaction of visit and treatment group, and interaction of baseline NPRS score and visit.|Least square (LS) mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.351|<|0.5224|TWO_SIDED|95.0|-0.468|0.918|||MMRM|||||0.918|-0.468|<0.5224
91593822|NCT05895552|183078305|SUPERIORITY|The MMRM model includes treatment group, baseline NPRS score, visit, interaction of visit and treatment group, and interaction of baseline NPRS score and visit.|LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.351|<|0.8223|TWO_SIDED|95.0|-0.772|0.614|||MMRM|||||0.614|-0.772|<0.8223
91593823|NCT00829179|183078416|SUPERIORITY_OR_OTHER||Difference in Mean|11.0|STANDARD_DEVIATION|13.3||0.005||95.0|||||Sign test|||||||0.005
91593824|NCT00271596|183078420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166|STANDARD_ERROR_OF_MEAN|0.098||0.092|TWO_SIDED|95.0|-0.361|0.028|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.028|-0.361|0.092
91593825|NCT00271596|183078421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.337|STANDARD_ERROR_OF_MEAN|0.168||0.048|TWO_SIDED|95.0|-0.672|-0.003|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||-0.003|-0.672|0.048
91593826|NCT00271596|183078422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278|STANDARD_ERROR_OF_MEAN|0.268||0.302|TWO_SIDED|95.0|-0.81|0.254|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.254|-0.810|0.302
91648729|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|1.36||0.8656|TWO_SIDED|95.0|-2.58|3.04|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.04|-2.58|0.8656
91593827|NCT00271596|183078423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.153||0.708|TWO_SIDED|95.0|-0.361|0.246|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.246|-0.361|0.708
91593828|NCT00271596|183078424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.229|0.367|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.367|-0.229|0.646
91593829|NCT00271596|183078425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.174||0.23||95.0|-0.554|0.135|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.135|-0.554|0.230
91648730|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7113|TWO_SIDED|95.0|-3.41|2.36|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||2.36|-3.41|0.7113
91521930|NCT00608582|182918756|SUPERIORITY_OR_OTHER||||||<|0.237||||||p\<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.||||<0.237
91521931|NCT00608582|182918757|SUPERIORITY_OR_OTHER|||||||0.414||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||0.414
91521932|NCT00608582|182918757|SUPERIORITY_OR_OTHER||||||<|0.822||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.822
91782936|NCT00611026|183445577|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91782937|NCT00611026|183445577|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0019
91782938|NCT00611026|183445577|SUPERIORITY_OR_OTHER|||||||0.0148|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0148
91521933|NCT00608582|182918757|SUPERIORITY_OR_OTHER||||||<|0.835||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.835
91521934|NCT04922554|182918758|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|14.15||||0.2182|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.2182
91521935|NCT04922554|182918759|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|22.15||||0.046|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.0460
91782939|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0012
91782940|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0205
91782941|NCT00611026|183445578|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
91521936|NCT04922554|182918768|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.8||||0.824|TWO_SIDED|95.0|-6.01|7.52||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||7.52|-6.01|0.8240
91521937|NCT04922554|182918769|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.1||||0.2149|TWO_SIDED|95.0|-3.03|13.2||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.20|-3.03|0.2149
91521938|NCT04922554|182918770|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|8.3||||0.123|TWO_SIDED|95.0|-2.31|18.88||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||18.88|-2.31|0.1230
91521939|NCT04922554|182918771|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.5||||0.1168|TWO_SIDED|95.0|-1.41|12.43||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||12.43|-1.41|0.1168
91521940|NCT04922554|182918772|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|6.5||||0.0743|TWO_SIDED|95.0|-0.66|13.66||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.66|-0.66|0.0743
91521941|NCT04922554|182918773|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|7.1||||0.0899|TWO_SIDED|95.0|-1.13|15.23||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||15.23|-1.13|0.0899
91593830|NCT00271596|183078426|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.317|STANDARD_ERROR_OF_MEAN|0.482||0.512|TWO_SIDED|95.0|-1.276|0.642|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.642|-1.276|0.512
91521942|NCT04922554|182918774|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.5||||0.9019|TWO_SIDED|95.0|-7.6|8.59||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||8.59|-7.60|0.9019
91593831|NCT00271596|183078427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.17||0.12|TWO_SIDED|95.0|-4.3|0.5|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.50|-4.30|0.12
91593832|NCT00271596|183078428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.68||0.49|TWO_SIDED|95.0|-1.87|0.91|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.91|-1.87|0.49
91593833|NCT00271596|183078429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-2.5|STANDARD_ERROR_OF_MEAN|1.23||0.05|TWO_SIDED|95.0|-5.04|0.04||Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|Mixed Models Analysis|||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.04|-5.04|0.05
91593834|NCT02969915|183078437|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.64|2.26||||||||2.26|0.64|
91593835|NCT02969915|183078438|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.91|1.9||||||||1.90|0.91|
91593836|NCT02969915|183078439|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.7|1.95||||||||1.95|0.70|
91593837|NCT02969915|183078440|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95||||||||1.95|0.85|
91593838|NCT02969915|183078441|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.79|1.75||||||||1.75|0.79|
91593839|NCT02969915|183078442|SUPERIORITY||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.38|5.76||||||||5.76|0.38|
91593840|NCT02969915|183078443|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.68|1.36||||||||1.36|0.68|
91593841|NCT02969915|183078444|SUPERIORITY||Risk Ratio, log|1.38|||||TWO_SIDED|95.0|0.77|2.46||||||||2.46|0.77|
91593842|NCT02969915|183078445|SUPERIORITY||Risk Ratio (RR)|0.39|||||TWO_SIDED|95.0|0.09|1.8||||||||1.80|0.09|
91782942|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0038|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0038
91593843|NCT04580446|183078451|OTHER|Descriptive analysis used to identify the dose level associated with ≤1 of 6 participants experiencing a dose-limiting toxicity (DLT), consistent with standard 3+3 design methodology.|Maximally Tolerated Dose/Fractionation|46.5|||||TWO_SIDED||||||||MTD/fractionation determined as 46.5 Gy in 15 fractions based on incidence of DLTs during dose escalation (3 + 3 design)|"Estimation Parameter: Maximally Tolerated Dose/Fractionation Description: The maximally tolerated dose (MTD)/fractionation of hypofractionated radiation therapy was determined based on the incidence of dose-limiting toxicities (DLTs) observed during the dose-escalation phase.~Estimate: 46.5 Gy × 15 fractions"||||
91593844|NCT04206605|183078461|SUPERIORITY||Rate Ratio|1.02|||=|0.899|TWO_SIDED|95.0|0.71|1.47||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.47|0.71|=0.899
91593845|NCT04206605|183078462|SUPERIORITY||Risk Difference (RD)|0.003|||=|1|TWO_SIDED|95.0|-0.153|0.114||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from Cochran-Mantel-Haenszel (CMH) test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.114|-0.153|=1.000
91593846|NCT04206605|183078463|SUPERIORITY||Rate Ratio|0.96|||=|0.852|TWO_SIDED|95.0|0.62|1.48||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.48|0.62|=0.852
91593847|NCT04206605|183078464|SUPERIORITY||Rate Ratio|1.1|||=|0.66|TWO_SIDED|95.0|0.72|1.7||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.70|0.72|=0.660
91593848|NCT04206605|183078465|SUPERIORITY||Risk Difference (RD)|-0.087|||=|0.25|TWO_SIDED|95.0|-0.28|0.063||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from CMH test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.063|-0.280|=0.250
91593849|NCT04206605|183078467|SUPERIORITY||Rate Ratio|0.97|||=|0.896|TWO_SIDED|95.0|0.58|1.61||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.61|0.58|=0.896
91593850|NCT04206605|183078469|SUPERIORITY||||||=|0.498||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.498
91782943|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0219|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0219
91782944|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0001
91593851|NCT04206605|183078470|SUPERIORITY||||||=|0.184||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.184
91593852|NCT01392677|183078544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1022|<|0.0001|TWO_SIDED|95.0|-0.89|-0.49||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Mixed Models Analysis|Longitudinal repeated measures model using mixed model with treatment group, baseline value, week and week\*treatment and week\*baseline||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-0.89|<0.0001
91593853|NCT01392677|183078545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.45|STANDARD_ERROR_OF_MEAN|4.8846|<|0.0001|TWO_SIDED|95.0|-43.08|-23.82||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-23.82|-43.08|<0.0001
91593854|NCT01392677|183078546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|0.3651|<|0.0001|TWO_SIDED|95.0|-2.79|-1.35||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.35|-2.79|<0.0001
91593855|NCT01392677|183078547|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.7|STANDARD_ERROR_OF_MEAN|5.056|<|0.0001|TWO_SIDED|95.0|10.7|30.6||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsiatis, Davidian, Zhang \& Lu, with adjustment for baseline value||H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0||30.6|10.7|<0.0001
91593856|NCT01392677|183078548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.6677||0.025|TWO_SIDED|95.0|-7.05|-0.48||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.48|-7.05|0.025
91593857|NCT01357577|183078557|OTHER|||||||0.48||||||P-Value show above is for post-assessment time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.48
91593858|NCT01357577|183078557|OTHER|||||||0.12||||||The p-value shown above is for the 6-month time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.12
91593859|NCT01357577|183078557|OTHER|||||||0.65||||||The p-value shown above refers to the treatment main effect.|Mixed Models Analysis|||||||.65
91593860|NCT01357577|183078557|OTHER|||||||0.072||||||The p-value shown above refers to the timepoint main effect.|Mixed Models Analysis|||||||.072
91593861|NCT01357577|183078557|OTHER|||||||0.005|||||||Mixed Models Analysis|The p-value shown above refers to the interaction.||||||.0050
91593862|NCT01357577|183078557|OTHER|||||||0.12|||||||Mixed Models Analysis|The p-value shown above refers to the site main effect.||||||.12
91593863|NCT01357577|183078558|OTHER|mixed-effects linear regression model adjusted for study site and the baseline value of the dependent variable.||||||0.12||||||Post-treatment P-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (Alcohol Use) score.||||||.12
91593864|NCT01357577|183078558|OTHER|||||||0.84||||||6-month P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.84
91593865|NCT01357577|183078558|OTHER|||||||0.26||||||treatment main effect|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.26
91593866|NCT01357577|183078558|OTHER|||||||0.14||||||Timepoint main effect P-value|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.14
91593867|NCT01357577|183078558|OTHER|||||||0.29||||||interaction|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.29
91593868|NCT01357577|183078558|OTHER|||||||0.16||||||Site main effect P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.16
91593869|NCT01357577|183078559|OTHER|||||||0.66||||||Post-treatment p-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (drug score).||||||.66
91782945|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0805|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0805
91782946|NCT00611026|183445578|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0093
91782947|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0374|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.0|-0.7|0.0374
91782948|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3161|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.2|-0.5|0.3161
91593870|NCT01357577|183078559|OTHER|||||||0.53||||||6-month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.53
91593871|NCT01357577|183078559|OTHER|||||||0.86||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.86
91593872|NCT01357577|183078559|OTHER|||||||0.16||||||Timepoint main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.16
91593873|NCT01357577|183078559|OTHER|||||||0.47||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.47
91593874|NCT01357577|183078559|OTHER|||||||0.19||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.19
91593875|NCT01357577|183078560|OTHER|||||||0.18||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.18
91593876|NCT01357577|183078560|OTHER|||||||0.45||||||P-value at 6 months.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.45
91593877|NCT01357577|183078560|OTHER|||||||0.73||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.73
91593878|NCT01357577|183078560|OTHER|||||||0.63||||||Timepoint main effect P-Value|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.63
91593879|NCT01357577|183078560|OTHER|||||||0.024||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.024
91593880|NCT01357577|183078560|OTHER|||||||0.15||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.15
91593881|NCT01357577|183078561|OTHER|||||||0.48||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.48
91593882|NCT01357577|183078561|OTHER|||||||0.2||||||6-Month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.20
91593883|NCT01357577|183078561|OTHER|||||||0.26||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.26
91593884|NCT01357577|183078561|OTHER|||||||0.71||||||Timepoint main effect.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.71
91593885|NCT01357577|183078561|OTHER|||||||0.56||||||Interaction main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.56
91593886|NCT01357577|183078561|OTHER|||||||0.51||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.51
91593887|NCT06689527|183078580|OTHER||Ratio of Geometric LS Mean (%)|83.95|||||TWO_SIDED|90.0|74.08|93.59|||||The linear mixed model was applied to log-transformed PK parameter AUC0-tlast, of midazolam based on the PK Set to assess treatment differences on the log scale of midazolam with vamorolone vs midazolam alone (Day 14 vs Day 1).|Linear model with treatment as fixed effect and subjects as random effect||93.59|74.08|
91593888|NCT06689527|183078581|OTHER||Ratio of Geometric LS Mean (|83.05|||||TWO_SIDED|90.0|74.18|95.0|||||The linear mixed model was applied to log-transformed PK parameter AUC0-inf of midazolam based on the PK Set to assess treatment differences on the log scale of midazolam with vamorolone vs midazolam alone (Day 14 vs Day 1)|Linear model with treatment as fixed effect and subjects as random effect||95.00|74.18|
91593889|NCT06689527|183078582|OTHER||Ratio of Geometric LS Mean (%)|88.59|||||TWO_SIDED|90.0|79.44|98.79|||||The linear mixed model was applied to log-transformed PK parameter Cmax of midazolam based on the PK Set to assess treatment differences on the log scale of midazolam with vamorolone vs midazolam alone (Day 14 vs Day 1).|Linear model with treatment as fixed effect and subject as random effect||98.79|79.44|
91593890|NCT06689527|183078583|OTHER||Ratio of Geometric LS Mean (%)|114.55|||||TWO_SIDED|90.0|101.59|129.18|||||The linear mixed model was applied to log-transformed PK parameter AUC0-tlast of 1'-hydroxymidazolam based on the PK Set to assess treatment differences on the log scale of midazolam with vamorolone vs midazolam alone (Day 14 vs Day 1)|Linear model with treatment as fixed effect and subject as random effect||129.18|101.59|
91593891|NCT06689527|183078584|OTHER||Ratio of Geometric LS Mean (%)|113.7|||||TWO_SIDED|90.0|101.29|127.63|||||The linear mixed model was applied to log-transformed PK parameter AUC0-inf, of 1'-hydroxymidazolam based on the PK Set to assess treatment differences on the log scale of midazolam with vamorolone vs midazolam alone (Day 14 vs Day 1)|Linear model with treatment as fixed effect and subject as random effect||127.63|101.29|
91593892|NCT06689527|183078585|OTHER||Ratio of Geometric LS Mean (%)|128.67|||||TWO_SIDED|90.0|105.36|157.13|||||The linear mixed model was applied to log-transformed PK parameter Cmax of 1'-hydroxymidazolam based on the PK Set to assess treatment differences on the log scale of midazolam with vamorolone vs midazolam alone (Day 14 vs Day 1)|Linear model with treatment as fixed effect and subject as random effect||157.13|105.36|
91593893|NCT00666458|183078610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.01|0.2||||||||0.20|-0.01|
91593894|NCT00666458|183078611|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8|||||TWO_SIDED|95.0|-9.0|3.5||||||||3.5|-9.0|
91593895|NCT00666458|183078612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42|STANDARD_ERROR_OF_MEAN|2.064|||TWO_SIDED|95.0|1.37|9.47||||||||9.47|1.37|
91593896|NCT00666458|183078613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|0.08|0.53||||||||0.53|0.08|
91648731|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|2.21||0.2204|TWO_SIDED|95.0|-7.32|1.77|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.77|-7.32|0.2204
91593897|NCT01035099|183078630|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.31
91593898|NCT01035099|183078631|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.19
91593899|NCT01035099|183078634|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.12
91593900|NCT01035099|183078635|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.77
91593901|NCT01035099|183078636|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.63
91593902|NCT01035099|183078638|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.14
91593903|NCT01035099|183078639|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||<0.0001
91593904|NCT01035099|183078640|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.58
91593905|NCT01035099|183078642|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.42
91593906|NCT01148537|183078648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001|TWO_SIDED|90.0|3.4|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||||8.4|3.4|< .001
91593907|NCT01148537|183078649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.77|TWO_SIDED|90.0|-1.8|2.6|||ANCOVA||For the comparison of BTDS to placebo, the subjects randomized to moxifloxacin were excluded.|||2.6|-1.8|.770
91593908|NCT01148537|183078650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|||<|0.001|TWO_SIDED|90.0|3.3|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||Day 13 analysis||8.4|3.3|< .001
91593909|NCT01148537|183078651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.64|||<|0.001|TWO_SIDED|90.0|5.4|9.9|||ANCOVA|ANCOVA model with average baseline as a covariate, and with gender and treatment as main effects||||9.9|5.4|< .001
91593910|NCT01148537|183078652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.936|TWO_SIDED|90.0|-2.9|2.6|||ANCOVA|||Day 6 analysis||2.6|-2.9|.936
91593911|NCT01148537|183078652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.16|||<|0.001|TWO_SIDED|90.0|4.2|10.1|||ANCOVA|||Day 13 analysis||10.1|4.2|< .001
91593912|NCT01148537|183078653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|||<|0.001|TWO_SIDED|90.0|5.5|10.9|||ANCOVA|||Day 6 analysis||10.9|5.5|< .001
91593913|NCT01148537|183078653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|90.0|4.3|10.5|||ANCOVA|||Day 13 analysis||10.5|4.3|< .001
91782949|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1817|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.1|-0.5|0.1817
91782950|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.8|-1.6|<0.0001
91782951|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.2|-1.0|0.0054
91782952|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.3|-0.9|0.0005
91782953|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.6|-1.5|<0.0001
91782954|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1467|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.1|-0.7|0.1467
91782955|NCT00611026|183445579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.4|-1.1|<0.0001
91782956|NCT00611026|183445580|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0828
91782957|NCT00611026|183445580|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
91782958|NCT00611026|183445580|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0008
91782959|NCT00611026|183445580|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0022
91782960|NCT00611026|183445580|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
91782961|NCT00611026|183445580|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0008
91782962|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0576
91593914|NCT01148537|183078654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.427|TWO_SIDED|90.0|-1.4|4.0|||ANCOVA|||Day 6 analysis||4.0|-1.4|.427
91593915|NCT01148537|183078654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.01||||0.001|TWO_SIDED|90.0|3.2|8.8|||ANCOVA|||Day 13 analysis||8.8|3.2|.001
91593916|NCT01148537|183078655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.001|TWO_SIDED|90.0|4.2|9.6|||ANCOVA|||Day 6 analysis||9.6|4.2|< .001
91593917|NCT01148537|183078655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68||||0.006|TWO_SIDED|90.0|1.9|7.4|||ANCOVA|||Day 13 analysis||7.4|1.9|.006
91593918|NCT00896779|183078656|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
91593919|NCT00896779|183078656|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
91593920|NCT01843842|183078657|SUPERIORITY|||||||0.016|||||||Global Test Statistic|See O'Brien 1984, Pocock 1997.||||||0.016
91593921|NCT01843842|183078658|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91593922|NCT01843842|183078659|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91593923|NCT01843842|183078660|SUPERIORITY|||||||0.0283||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Day 3, doctor's examination)||||0.0283
91593924|NCT01843842|183078660|SUPERIORITY|||||||0.3264|||||||Kruskal-Wallis|||Non-specific (Day 3, doctor's examination)||||0.3264
91593925|NCT01843842|183078660|SUPERIORITY|||||||0.706|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Day 3, doctor's examination)||||0.7060
91593926|NCT01843842|183078660|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||All symptoms (Day 3, doctor's examination)||||0.25
91648732|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.87||0.5298|TWO_SIDED|95.0|-5.04|2.66|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||2.66|-5.04|0.5298
91593927|NCT01843842|183078660|SUPERIORITY|||||||0.244|||||||ANCOVA|||Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)||||0.244
91593928|NCT01843842|183078661|SUPERIORITY|||||||0.1158|||||||Kruskal-Wallis|||Duration of fever based on Patient Diary Data||||0.1158
91782963|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.2230
91593929|NCT01843842|183078661|SUPERIORITY|||||||0.5755|||||||Kruskal-Wallis|||Duration of non-specific symptoms based on Patient Diary Data||||0.5755
91593930|NCT01843842|183078661|SUPERIORITY|||||||0.4331|||||||Kruskal-Wallis|||Duration of nasal/ throat/ chest symptoms based on Patient Diary Data||||0.4331
91593931|NCT01843842|183078661|SUPERIORITY|||||||0.356|||||||Kruskal-Wallis|||Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data||||0.3560
91593932|NCT01843842|183078662|SUPERIORITY|||||||0.0166||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1, 3, 6 doctor's examination)||||0.0166
91593933|NCT01843842|183078662|SUPERIORITY|||||||0.082|||||||Kruskal-Wallis|||Non-specific (Days 1, 3, 6 doctor's examination)||||0.0820
91593934|NCT01843842|183078662|SUPERIORITY|||||||0.7227|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)||||0.7227
91593935|NCT01843842|183078662|SUPERIORITY|||||||0.2645|||||||Kruskal-Wallis|||All symptoms (Days 1, 3, 6 doctor's examination)||||0.2645
91593936|NCT01843842|183078662|SUPERIORITY|||||||0.0142||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1-5, patient diary data)||||0.0142
91593937|NCT01843842|183078662|SUPERIORITY|||||||0.0145||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Non-specific (Days 1-5, patient diary data)||||0.0145
91593938|NCT01843842|183078662|SUPERIORITY|||||||0.2963|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1-5, patient diary data)||||0.2963
91593939|NCT01843842|183078662|SUPERIORITY|||||||0.0364||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||All symptoms (Days 1-5, patient diary data)||||0.0364
91593940|NCT01843842|183078663|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.40
91593941|NCT00632099|183078665|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
91593942|NCT02018822|183078689|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2552|||||||Chi-squared|||||||0.2552
91593943|NCT02018822|183078690|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2235|||||||Chi-squared|||||||0.2235
91593944|NCT02018822|183078691|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3891|||||||Chi-squared|||||||0.3891
91593945|NCT02018822|183078692|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
91593946|NCT02018822|183078693|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
91593947|NCT02018822|183078694|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2707|||||||Chi-squared|||||||0.2707
91593948|NCT03201458|183078695|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.027|TWO_SIDED|90.0|0.35|0.93||One-sided test|Log Rank|||||0.93|0.35|0.027
91593949|NCT03201458|183078696|SUPERIORITY||Odds Ratio (OR)|2.3||||0.22|TWO_SIDED||||||Fisher Exact|||||||0.22
91593950|NCT03201458|183078698|SUPERIORITY|||||||0.41||||||One-sided test|Log Rank|||||||0.410
91593951|NCT02184195|183078717|SUPERIORITY||Hazard Ratio (HR)|0.531||||0.0038|TWO_SIDED|95.0|0.346|0.815|||Log-rank test|||||0.815|0.346|0.0038
91593952|NCT02184195|183078718|OTHER||Hazard Ratio (HR)|0.831||||0.3487|TWO_SIDED|95.0|0.564|1.224|||Log-rank test|||||1.224|0.564|0.3487
91593953|NCT02184195|183078719|SUPERIORITY||Hazard Ratio (HR)|0.659||||0.0613|TWO_SIDED|95.0|0.426|1.02|||Log-rank test|||||1.020|0.426|0.0613
91593954|NCT02184195|183078720|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0111|TWO_SIDED|95.0|0.418|0.894|||Log-rank test|||||0.894|0.418|0.0111
91593955|NCT02184195|183078721|SUPERIORITY||Hazard Ratio (HR)|0.442|||<|0.0001|TWO_SIDED|95.0|0.297|0.658|||Log-rank test|||||0.658|0.297|<0.0001
91593956|NCT02184195|183078722|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.289|0.627|||Log-rank test|||||0.627|0.289|<0.0001
91593957|NCT02184195|183078723|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3273|TWO_SIDED|95.0|0.668|3.61|||Regression, Logistic|||||3.610|0.668|0.3273
91593958|NCT02184195|183078725|SUPERIORITY||Mean Difference (Final Values)|-2.21||||0.355|TWO_SIDED|95.0|-6.917|2.496|||Mixed Models Analysis|||||2.496|-6.917|0.355
91593959|NCT03002155|183078732|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparisons due to the pilot nature of the study, alpha level was 0.10.|ANOVA|||||||.26
91593960|NCT03002155|183078733|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
91593961|NCT03002155|183078734|SUPERIORITY|||||||0.24|||||||ANOVA|||For PROMIS Global Physical||||0.24
91593962|NCT03002155|183078734|SUPERIORITY|||||||0.8||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||For PROMIS Global Mental||||0.80
91593963|NCT03002155|183078735|SUPERIORITY|||||||0.81||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.81
91593964|NCT03002155|183078736|SUPERIORITY|||||||0.03||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.03
91593965|NCT01412554|183078760|OTHER|Only descriptive statistics|||||<|0.05|||||||Spearman|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient||Only an observational follow-up study|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient|||<0.05
91593966|NCT03302975|183078765|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||ANOVA|||||||0.001
91593967|NCT05998148|183078769|OTHER||Mean Difference (Net)|0.2||||0.91|TWO_SIDED|||||The threshold for statistical significance was p= 0.05.|t-test, 2 sided|Since 2 hypothesis tests are conducted, we applied a Bonferroni correction. Our new adjusted threshold level is 0.05/2= 0.025.|Treatment Difference = Virtual - Standard In-person|The null hypothesis states that the virtual group and in-person group exhibit no difference in mean PROMIS physical score. From the literature, an effect size of 0.618 was obtained from the PROMIS physical. Using a power of 80% and a significance level of 0.05, it was determined that a sample size of 34 per group would detect a statistical difference between the groups. An intention-to-treat analysis was conducted on the scores at the 6-month follow-up appointment.||||0.91
91593968|NCT05998148|183078769|OTHER||Mean Difference (Net)|-3.7||||0.077|TWO_SIDED|||||The threshold for statistical significance was p= 0.05.|t-test, 2 sided|Since 2 hypothesis tests are conducted, we applied a Bonferroni correction. Our new adjusted threshold level is 0.05/2= 0.025.|Treatment Difference = Virtual - Standard In-person|The null hypothesis states that the virtual group and in-person group exhibit no difference in mean PROMIS mental score. The minimum sample size determined for the PROMIS physical score was applied to this outcome score. An intention-to-treat analysis was conducted on the scores at the 6-month follow-up appointment.||||0.077
91593969|NCT05998148|183078769|OTHER||Mean Difference (Net)|0.56||||0.75|TWO_SIDED||||||t-test, 2 sided||Treatment Difference = Virtual - Standard In-person|The null hypothesis states that the virtual group and in-person group exhibit no difference in mean PROMIS physical score. From the literature, effect size of 0.618 was obtained from PROMIS physical. Using a power of 80% and a significance level of 0.05, it was determined that a sample size of 34 per group would detect a statistical difference between the groups. A per-protocol analysis was conducted on the scores at the 6-month follow-up appointment. There were 34 patients in each group.||||0.75
91593970|NCT05998148|183078769|OTHER||Mean Difference (Net)|-4.49||||0.049|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|Since 2 hypothesis tests are conducted, we applied a Bonferroni correction. Our new adjusted threshold level is 0.05/2= 0.025.|Treatment Difference = Virtual - Standard In-person|The null hypothesis states that the virtual group and in-person group exhibit no difference in mean PROMIS mental score. The minimum sample size determined for the PROMIS physical score was used for this analysis. A per-protocol analysis was conducted on the scores at the 6-month follow-up appointment. There were 34 patients in each group.||||0.049
91648733|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.9||0.3135|TWO_SIDED|95.0|-5.86|1.96|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.96|-5.86|0.3135
91648734|NCT00272961|183190172|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.95||0.2962|TWO_SIDED|95.0|-6.09|1.93|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.93|-6.09|0.2962
91648735|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.74|STANDARD_ERROR_OF_MEAN|5.39||0.4933|TWO_SIDED|95.0|-14.84|7.35|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.35|-14.84|0.4933
91593971|NCT05998148|183078770|OTHER||Mean Difference (Net)|3.84||||0.49|TWO_SIDED|||||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Treatment Difference = Virtual - Standard In-person|There were 27 patients in the virtual phone group. There were 26 patients in the standard in-person group.||||0.49
91593972|NCT05998148|183078771|OTHER||Mean Difference (Net)|3.65||||0.54|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Virtual - Standard In-person|There are 18 patients in the virtual group. There are 9 patients in the standard in-person group.||||0.54
91593973|NCT05998148|183078772|OTHER||Mean Difference (Net)|0.13||||0.39|TWO_SIDED|||||The threshold for statistical significance was p=0.05|t-test, 2 sided||Treatment Difference = Virtual - Standard In-person|There are 45 patients in the virtual phone group. There are 35 patients in the standard in-person group.||||0.39
91593974|NCT03834519|183078774|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2616|TWO_SIDED|95.0|0.77|1.14|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in survival assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.14|0.77|0.2616
91782964|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.3555|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.3555
91782965|NCT00611026|183445581|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
91782966|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0009
91782967|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.0071|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0071
91782968|NCT00611026|183445581|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
91782969|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.1764|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.1764
91782970|NCT00611026|183445581|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0001
91782971|NCT00611026|183445582|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
91782972|NCT00611026|183445582|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0003
91782973|NCT00611026|183445582|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0302
91593975|NCT03834519|183078775|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5544|TWO_SIDED|95.0|0.82|1.25|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in rPFS assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.25|0.82|0.5544
91593976|NCT03834519|183078776|OTHER|Treatment difference in TFST|Hazard Ratio (HR)|0.86||||||95.0|0.71|1.03|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.03|0.71|
91593977|NCT03834519|183078777|OTHER|Treatment difference in ORR|Difference in percentage|10.9|||||TWO_SIDED|95.0|4.0|17.1||||||||17.1|4.0|
91593978|NCT03834519|183078779|OTHER|Treatment difference in time to PSA progression|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.89|1.38|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.38|0.89|
91521943|NCT04922554|182918775|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|13.7||||0.0015|TWO_SIDED|95.0|5.43|21.89||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||21.89|5.43|0.0015
91593979|NCT03834519|183078780|OTHER|Treatment difference in SSRE|Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.78|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||0.78|0.38|
91593980|NCT03834519|183078781|OTHER|Treatment difference in time to radiographic soft tissue progression|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.62|1.0|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.00|0.62|
91648736|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.57||0.408|TWO_SIDED|95.0|-13.26|5.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.57|-13.26|0.4080
91593981|NCT03834519|183078782|OTHER|Treatment difference in TTPE|Hazard Ratio (HR)|0.95||||0.3643|TWO_SIDED|95.0|0.72|1.26|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.26|0.72|0.3643
91593982|NCT06608368|183078837|SUPERIORITY||Least Square Mean Difference|-6.2108|STANDARD_ERROR_OF_MEAN|4.0959||0.1332|TWO_SIDED|95.0|-14.3568|1.9353|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|||1.9353|-14.3568|0.1332
91648737|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|4.56||0.5936|TWO_SIDED|95.0|-11.86|6.93|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.93|-11.86|0.5936
91593983|NCT06608368|183078837|SUPERIORITY||Least Square Mean Difference|-2.9623|STANDARD_ERROR_OF_MEAN|4.1021||0.4722|TWO_SIDED|95.0|-11.1207|5.196|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|||5.1960|-11.1207|0.4722
91593984|NCT06608368|183078837|SUPERIORITY||Least Square Mean Difference|3.2484|STANDARD_ERROR_OF_MEAN|3.9692||0.4155|TWO_SIDED|95.0|-4.6456|11.1425|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|||11.1425|-4.6456|0.4155
91593985|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-4.739|STANDARD_ERROR_OF_MEAN|3.383||0.165|TWO_SIDED|95.0|-11.4672|1.9891|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Intensity||1.9891|-11.4672|0.1650
91593986|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-4.4392|STANDARD_ERROR_OF_MEAN|3.3248||0.1855|TWO_SIDED|95.0|-11.0516|2.1732|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Intensity||2.1732|-11.0516|0.1855
91782974|NCT00611026|183445582|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
91593987|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|0.2998|STANDARD_ERROR_OF_MEAN|3.2234||0.9261|TWO_SIDED|95.0|-6.1107|6.7104|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Intensity||6.7104|-6.1107|0.9261
91593988|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-2.7189|STANDARD_ERROR_OF_MEAN|3.2406||0.4039|TWO_SIDED|95.0|-9.1643|3.7265|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Duration||3.7265|-9.1643|0.4039
91593989|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-3.6986|STANDARD_ERROR_OF_MEAN|3.1959||0.2505|TWO_SIDED|95.0|-10.0548|2.6577|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Duration||2.6577|-10.0548|0.2505
91593990|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-0.9797|STANDARD_ERROR_OF_MEAN|3.1648||0.7577|TWO_SIDED|95.0|-7.2744|5.3151|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Duration||5.3151|-7.2744|0.7577
91593991|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-1.8461|STANDARD_ERROR_OF_MEAN|2.9755||0.5367|TWO_SIDED|95.0|-7.7642|4.072|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Tolerability||4.0720|-7.7642|0.5367
91593992|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-2.0435|STANDARD_ERROR_OF_MEAN|2.9907||0.4963|TWO_SIDED|95.0|-7.9916|3.9047|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Tolerability||3.9047|-7.9916|0.4963
91790353|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.081||0.456|TWO_SIDED|95.0|-0.219|0.098||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.098|-0.219|0.456
91790354|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790355|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.079||0.093|TWO_SIDED|95.0|-0.29|0.023||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.023|-0.290|0.093
91790356|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790357|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.082||0.75|TWO_SIDED|95.0|-0.187|0.135||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.135|-0.187|0.750
91790358|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790359|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.106||0.134|TWO_SIDED|95.0|-0.049|0.366||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.366|-0.049|0.134
91790360|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790361|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.103||0.316|TWO_SIDED|95.0|-0.099|0.305||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.305|-0.099|0.316
91790362|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|0.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91648738|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|4.79||0.7883|TWO_SIDED|95.0|-11.17|8.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.57|-11.17|0.7883
91648739|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|5.12||0.5719|TWO_SIDED|95.0|-13.46|7.6|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.60|-13.46|0.5719
91648740|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|4.33||0.3401|TWO_SIDED|95.0|-13.11|4.7|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||4.70|-13.11|0.3401
91648741|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.34||0.6329|TWO_SIDED|95.0|-11.01|6.82|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.82|-11.01|0.6329
91648742|NCT00272961|183190173|SUPERIORITY_OR_OTHER||LS Mean Difference|3.83|STANDARD_ERROR_OF_MEAN|4.51||0.4037|TWO_SIDED|95.0|-5.45|13.11|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||13.11|-5.45|0.4037
91648743|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|4.08||0.7685|TWO_SIDED|95.0|-7.19|9.62|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||9.62|-7.19|0.7685
91648744|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.88|STANDARD_ERROR_OF_MEAN|3.49||0.1739|TWO_SIDED|95.0|-12.07|2.3|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||2.30|-12.07|0.1739
91648745|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|3.61||0.4612|TWO_SIDED|95.0|-4.74|10.15|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||10.15|-4.74|0.4612
91648746|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|3.67||0.7172|TWO_SIDED|95.0|-8.9|6.21|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.21|-8.90|0.7172
91648747|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45|STANDARD_ERROR_OF_MEAN|4.12||0.4098|TWO_SIDED|95.0|-5.01|11.91|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||11.91|-5.01|0.4098
91648748|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|3.48||0.6943|TWO_SIDED|95.0|-8.54|5.78|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.78|-8.54|0.6943
91648749|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|STANDARD_ERROR_OF_MEAN|3.67||0.2042|TWO_SIDED|95.0|-2.76|12.31|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||12.31|-2.76|0.2042
91648750|NCT00272961|183190174|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|3.77||0.7791|TWO_SIDED|95.0|-6.69|8.83|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.83|-6.69|0.7791
91648751|NCT01507831|183190176|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.9|||<|0.0001|TWO_SIDED|95.0|-64.3|-59.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.4|-64.3|<0.0001
91648752|NCT01507831|183190177|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.5|||<|0.0001|TWO_SIDED|95.0|-65.9|-61.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.2|-65.9|<0.0001
91648753|NCT01507831|183190178|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.8|||<|0.0001|TWO_SIDED|95.0|-67.2|-62.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-62.4|-67.2|<0.0001
91648754|NCT01507831|183190179|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.5|||<|0.0001|TWO_SIDED|95.0|-67.9|-63.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-63.2|-67.9|<0.0001
91648755|NCT01507831|183190180|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.3|||<|0.0001|TWO_SIDED|95.0|-64.0|-58.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.5|-64.0|<0.0001
91648756|NCT01507831|183190181|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.0|||<|0.0001|TWO_SIDED|95.0|-56.3|-51.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.7|-56.3|<0.0001
91648757|NCT01507831|183190182|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-57.7|-53.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.2|-57.7|<0.0001
91648758|NCT01507831|183190183|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.3|||<|0.0001|TWO_SIDED|95.0|-54.4|-50.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.2|-54.4|<0.0001
91521944|NCT04922554|182918776|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.9||||0.8269|TWO_SIDED|95.0|-7.26|9.05||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison of Omadacycline and Placebo for activity score has been presented.|||9.05|-7.26|0.8269
91521945|NCT04922554|182918776|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.2||||0.9584|TWO_SIDED|95.0|-7.74|7.35||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for impact score has been presented|||7.35|-7.74|0.9584
91521946|NCT04922554|182918776|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.0||||0.2123|TWO_SIDED|95.0|-12.88|2.92||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for symptom score has been presented.|||2.92|-12.88|0.2123
91521947|NCT04922554|182918776|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.8||||0.8161|TWO_SIDED|95.0|-7.58|5.99||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for total score has been presented.|||5.99|-7.58|0.8161
91648759|NCT01507831|183190184|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.7|||<|0.0001|TWO_SIDED|95.0|-55.7|-51.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.6|-55.7|<0.0001
91782975|NCT00611026|183445582|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0007
91782976|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0701|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||0.0|-0.1|0.0701
91782977|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.4823|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.1|0.4823
91782978|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1702|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.0|-0.1|0.1702
91782979|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.1|-0.3|<0.0001
91782980|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0059|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.0|-0.2|0.0059
91521948|NCT04922554|182918777|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.7||||0.001|TWO_SIDED|95.0|-8.95|-2.38||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||-2.38|-8.95|0.0010
91521949|NCT04922554|182918778|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|39.61||||0.002|TWO_SIDED|95.0|16.66|62.56|||Fisher Exact|||||62.56|16.66|0.0020
91521950|NCT04922554|182918779|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|15.41||||0.3051|TWO_SIDED|95.0|-9.1|39.93|||Fisher Exact|||||39.93|-9.10|0.3051
91782981|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0014|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.0|-0.2|0.0014
91782982|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.1|-0.3|<0.0001
91593993|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-0.1974|STANDARD_ERROR_OF_MEAN|2.8888||0.9457|TWO_SIDED|95.0|-5.9429|5.5481|||Mixed Model with Repeated Measures||Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Tolerability||5.5481|-5.9429|0.9457
91593994|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-4.8837|STANDARD_ERROR_OF_MEAN|4.0222||0.2281|TWO_SIDED|95.0|-12.8837|3.1163|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Description||3.1163|-12.8837|0.2281
91782983|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.311|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.1|0.3110
91782984|NCT00611026|183445583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0004|TWO_SIDED|95.0|-0.2|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.1|-0.2|0.0004
91782985|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.0136|TWO_SIDED|95.0|-2.7|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.3|-2.7|0.0136
91782986|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1918|TWO_SIDED|95.0|-2.0|0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.4|-2.0|0.1918
91782987|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1505|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.3|-1.7|0.1505
91782988|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.2|-2.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-2.6|-5.2|<0.0001
91782989|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0034|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.7|-3.3|0.0034
91782990|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0006|TWO_SIDED|95.0|-3.0|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.8|-3.0|0.0006
91782991|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.0|-2.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-2.3|-5.0|<0.0001
91782992|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.0859|TWO_SIDED|95.0|-2.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.2|-2.5|0.0859
91782993|NCT00611026|183445584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-1.4|-3.6|<0.0001
91782994|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 1.||||0.0008
91782995|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.||||0.0024
91782996|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.6514|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.||||0.6514
91782997|NCT00611026|183445585|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 4.||||<0.0001
91521951|NCT04922554|182918780|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.3552|||||||Wilcoxon rank sum test|||||||0.3552
91782998|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.||||0.0063
91521952|NCT04922554|182918781|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0753|||||||Wilcoxon rank sum test|||||||0.0753
91593995|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|-3.9754|STANDARD_ERROR_OF_MEAN|4.0489||0.329|TWO_SIDED|95.0|-12.0283|4.0775|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Description||4.0775|-12.0283|0.3290
91521953|NCT04922554|182918783|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Odds Ratio (OR)|3.84||||0.0168|TWO_SIDED|95.0|1.24|11.87|||Chi-squared|||||11.87|1.24|0.0168
91593996|NCT06608368|183078838|SUPERIORITY||Least Square Mean Difference|0.9083|STANDARD_ERROR_OF_MEAN|3.9297||0.8178|TWO_SIDED|95.0|-6.9076|8.7243|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Description||8.7243|-6.9076|0.8178
91593997|NCT06608368|183078839|SUPERIORITY||Least Square Mean Difference|-0.6315|STANDARD_ERROR_OF_MEAN|0.351||0.0756|TWO_SIDED|95.0|-1.3296|0.06658|||Mixed Model with Repeated Measures||Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|||0.06658|-1.3296|0.0756
91593998|NCT06608368|183078839|SUPERIORITY||Least Square Mean Difference|-0.6447|STANDARD_ERROR_OF_MEAN|0.3589||0.0761|TWO_SIDED|95.0|-1.3586|0.06924|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|||0.06924|-1.3586|0.0761
91593999|NCT06608368|183078839|SUPERIORITY||Least Square Mean Difference|-0.01316|STANDARD_ERROR_OF_MEAN|0.3469||0.9698|TWO_SIDED|95.0|-0.7031|0.6767|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|||0.6767|-0.7031|0.9698
91782999|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0494|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.||||0.0494
91594000|NCT06608368|183078842|SUPERIORITY||Least Square Mean Difference|-6.0228|STANDARD_ERROR_OF_MEAN|5.9481||0.3142|TWO_SIDED|95.0|-17.8534|5.8078|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|||5.8078|-17.8534|0.3142
91783000|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 12.||||0.0003
91783001|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0991|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.||||0.0991
91783002|NCT00611026|183445585|SUPERIORITY_OR_OTHER|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.||||0.0169
91783003|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0009
91783004|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.0279|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0279
91783005|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.2817|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||||0.2817
91783006|NCT00611026|183445586|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
91783007|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0001
91783008|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0177
91783009|NCT00611026|183445586|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
91594001|NCT06608368|183078842|SUPERIORITY||Least Square Mean Difference|-9.3856|STANDARD_ERROR_OF_MEAN|5.9568||0.1189|TWO_SIDED|95.0|-21.2335|2.4624|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|||2.4624|-21.2335|0.1189
91594002|NCT06608368|183078842|SUPERIORITY||Least Square Mean Difference|-3.3627|STANDARD_ERROR_OF_MEAN|5.7636||0.5612|TWO_SIDED|95.0|-14.8264|8.1009|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|||8.1009|-14.8264|0.5612
91783010|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0107
91783011|NCT00611026|183445586|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0005
91783012|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0011
91783013|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0072
91783014|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.3713|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 1.||||0.3713
91783015|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0002
91594003|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-0.9595|STANDARD_ERROR_OF_MEAN|4.7895||0.8417|TWO_SIDED|95.0|-10.4856|8.5665|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Intensity||8.5665|-10.4856|0.8417
91594004|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-3.5821|STANDARD_ERROR_OF_MEAN|4.7059||0.4487|TWO_SIDED|95.0|-12.942|5.7777|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Intensity||5.7777|-12.9420|0.4487
91594005|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-2.6226|STANDARD_ERROR_OF_MEAN|4.5624||0.567|TWO_SIDED|95.0|-11.697|6.4517|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Intensity||6.4517|-11.6970|0.5670
91594006|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-2.4045|STANDARD_ERROR_OF_MEAN|3.9029||0.5395|TWO_SIDED|95.0|-10.1672|5.3583|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Duration||5.3583|-10.1672|0.5395
91594007|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-4.1471|STANDARD_ERROR_OF_MEAN|3.8479||0.2843|TWO_SIDED|95.0|-11.8005|3.5062|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Duration||3.5062|-11.8005|0.2843
91783016|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.1485
91783017|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0040
91783018|NCT00611026|183445587|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
91783019|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0060
91783020|NCT00611026|183445587|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0016
91783021|NCT00611026|183445588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.5|-4.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-4.7|-9.5|<0.0001
91783022|NCT00611026|183445588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.2||0.0458|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-4.8|0.0458
91783023|NCT00611026|183445588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-2.7|-6.6|<0.0001
91783024|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|3.4|7.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||7.9|3.4|<0.0001
91783025|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0429|TWO_SIDED|95.0|0.1|4.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.||4.6|0.1|0.0429
91783026|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.9||0.0003|TWO_SIDED|95.0|1.5|5.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.||5.2|1.5|0.0003
91783027|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|4.0|9.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||9.2|4.0|<0.0001
91783028|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.0795|TWO_SIDED|95.0|-0.3|4.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.||4.9|-0.3|0.0795
91783029|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|2.1|6.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.||6.3|2.1|<0.0001
91783030|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|4.3|9.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||9.6|4.3|<0.0001
91594008|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-1.7427|STANDARD_ERROR_OF_MEAN|3.8124||0.6488|TWO_SIDED|95.0|-9.3255|5.8401|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Duration||5.8401|-9.3255|0.6488
91594009|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|0.6984|STANDARD_ERROR_OF_MEAN|3.7493||0.8527|TWO_SIDED|95.0|-6.7589|8.1556|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Tolerability||8.1556|-6.7589|0.8527
91594010|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-3.2212|STANDARD_ERROR_OF_MEAN|3.7677||0.395|TWO_SIDED|95.0|-10.7149|4.2726|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Tolerability||4.2726|-10.7149|0.3950
91594011|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-3.9195|STANDARD_ERROR_OF_MEAN|3.6397||0.2847|TWO_SIDED|95.0|-11.1588|3.3198|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Tolerability||3.3198|-11.1588|0.2847
91594012|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-2.4837|STANDARD_ERROR_OF_MEAN|4.6595||0.5954|TWO_SIDED|95.0|-11.7512|6.7839|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|LMS Description||6.7839|-11.7512|0.5954
91594013|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-2.9779|STANDARD_ERROR_OF_MEAN|4.6891||0.5271|TWO_SIDED|95.0|-12.3044|6.3485|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|LMS Description||6.3485|-12.3044|0.5271
91594014|NCT06608368|183078843|SUPERIORITY||Least Square Mean Difference|-0.4942|STANDARD_ERROR_OF_MEAN|4.5519||0.9138|TWO_SIDED|95.0|-9.5478|8.5593|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|LMS Description||8.5593|-9.5478|0.9138
91783031|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0229|TWO_SIDED|95.0|0.4|5.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.||5.7|0.4|0.0229
91783032|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|1.1||0.0004|TWO_SIDED|95.0|1.7|6.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.||6.0|1.7|0.0004
91783033|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.2||0.0003|TWO_SIDED|95.0|2.0|6.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||6.9|2.0|0.0003
91783034|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.2||0.0923|TWO_SIDED|95.0|-0.3|4.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.||4.5|-0.3|0.0923
91783035|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.0||0.018|TWO_SIDED|95.0|0.4|4.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.||4.4|0.4|0.0180
91783036|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|1.3|5.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||5.1|1.3|0.0011
91783037|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.0||0.2208|TWO_SIDED|95.0|-0.7|3.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.||3.1|-0.7|0.2208
91783038|NCT00611026|183445589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0117|TWO_SIDED|95.0|0.4|3.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.||3.5|0.4|0.0117
91783039|NCT02817464|183445673|OTHER||Geometric Mean Ratio|1.84|||||TWO_SIDED|90.0|1.44|2.36||||||||2.36|1.44|
91783040|NCT02817464|183445674|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.33|1.33||||||||1.33|0.33|
91783041|NCT02817464|183445676|OTHER||Geometric Mean Ratio|1.67|||||TWO_SIDED|90.0|1.33|2.09||||||||2.09|1.33|
91783042|NCT02817464|183445677|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.3|2.01||||||||2.01|1.30|
91783043|NCT02817464|183445678|OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|1.04|1.4||||||||1.40|1.04|
91783044|NCT02817464|183445679|OTHER||Geometric Mean Ratio|0.51|||||TWO_SIDED|90.0|0.23|1.13||||||||1.13|0.23|
91783045|NCT02817464|183445681|OTHER|||||||0.0073|||||||Log Rank|||||||0.0073
91783046|NCT04292899|183445700|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1563|TWO_SIDED|95.0|0.507|1.115||P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.|Proportional odds model|||||1.115|0.507|0.1563
91783047|NCT04292899|183445700|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0368|TWO_SIDED|95.0|0.458|0.976||P-value was calculated using a proportional odds model with treatment as the independent variable.|Proportional odds model|||||0.976|0.458|0.0368
91783048|NCT04292899|183445701|SUPERIORITY||Difference in Percentages|1.3||||0.7678|TWO_SIDED|95.0|-7.4|10.0||P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.|Cochran-Mantel-Haenszel|||||10.0|-7.4|0.7678
91648760|NCT01507831|183190185|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-39.1|-35.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.9|-39.1|<0.0001
91783049|NCT00948441|183445702|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||t-test, 2 sided|||matched pairs T test to compare infection rates during the two study periods||||0.012
91783050|NCT04674761|183445707|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.277||0.0012|TWO_SIDED|95.0|-1.44|-0.33|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline score as a covariate, and baseline age stratification, baseline direct bilirubin, treatment group, time (in months), and treatment-by-time interaction as fixed effects. One-sided p-value was reported.||-0.33|-1.44|0.0012
91783051|NCT04674761|183445708|SUPERIORITY||LS mean difference|-112.74|STANDARD_ERROR_OF_MEAN|32.864||0.0006|TWO_SIDED|95.0|-178.78|-46.69|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline serum bile acid (sBA) concentration data as a covariate, and baseline age stratification, treatment group, visits (Weeks 4, 8, 12, 16, 20, 24), and treatment-by-visit interaction as fixed effects. The comparison of treatment difference in change from baseline to the average of Week 20 and Week 24 is estimated and tested using contrast. One-sided p-value was reported.||-46.69|-178.78|0.0006
91783052|NCT05340478|183445719|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91783053|NCT01032889|183445726|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3||||0.052|TWO_SIDED|95.0|-0.61|0.0|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.00|-0.61|0.052
91783054|NCT01032889|183445726|SUPERIORITY_OR_OTHER||Difference from placebo|-0.5||||0.003|TWO_SIDED|95.0|-0.77|-0.16|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.16|-0.77|0.003
91783055|NCT01032889|183445727|SUPERIORITY_OR_OTHER||Difference from placebo|-0.2||||0.117|TWO_SIDED|95.0|-0.55|0.06|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.06|-0.55|0.117
91783056|NCT01032889|183445727|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|||<|0.001|TWO_SIDED|95.0|-0.91|-0.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.30|-0.91|<0.001
91783057|NCT01032889|183445728|SUPERIORITY_OR_OTHER||Difference from placebo|-1.4||||0.005|TWO_SIDED|95.0|-2.44|-0.46|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.46|-2.44|0.005
91783058|NCT01032889|183445728|SUPERIORITY_OR_OTHER||Difference from placebo|-2.5|||<|0.001|TWO_SIDED|95.0|-3.48|-1.48|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-1.48|-3.48|<0.001
91783059|NCT01032889|183445729|SUPERIORITY_OR_OTHER||Difference from placebo|-606.0||||0.166|TWO_SIDED|95.0|-1482.0|269.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||269.3|-1482|0.166
91783060|NCT01032889|183445729|SUPERIORITY_OR_OTHER||Difference from placebo|-110.0||||0.803|TWO_SIDED|95.0|-1013.0|792.6|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||792.6|-1013|0.803
91783061|NCT01032889|183445730|SUPERIORITY_OR_OTHER||Difference from placebo|-1.5|||<|0.001|TWO_SIDED|95.0|-2.32|-0.69|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.69|-2.32|<0.001
91783062|NCT01032889|183445730|SUPERIORITY_OR_OTHER||Difference from placebo|-1.7|||<|0.001|TWO_SIDED|95.0|-2.46|-0.85|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.85|-2.46|<0.001
91783063|NCT01500720|183445731|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.169|||<|0.0001|TWO_SIDED|95.0|1.563|3.01||P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.|Stratified Two-Sided Log-Rank Test||Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.|||3.01|1.563|<0.0001
91783064|NCT03532451|183445780|SUPERIORITY|||||||0.08|||||||Wilcoxon Signed-Rank Test|||Null hypothesis is the change in CD8+ cell density is not significantly different from zero.||||0.08
91783065|NCT03532451|183445780|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank Test|||||||0.002
91783066|NCT03532451|183445781|SUPERIORITY|||||||0.88|||||||Wilcoxon rank sum test|||||||0.88
91783067|NCT00525161|183445790|SUPERIORITY_OR_OTHER||Clinical Response Rate at 3 months|0.0|||||TWO_SIDED||||||||Defined as complete response/partial response after 3 months of adding sorafenib to endocrine therapy|Based on known historical response rate to sorafenib of no better than 5-10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.||||
91783068|NCT00525161|183445791|SUPERIORITY_OR_OTHER||Median Progression Free Survival|6.1|||||TWO_SIDED|95.0|2.6|11.3||||||||11.3|2.6|
91783069|NCT04845568|183445823|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.08||0.592|TWO_SIDED|95.0|-3.16|5.43||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for physical activity does not differ between conditions.||5.43|-3.16|0.592
91790363|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.106||0.218|TWO_SIDED|95.0|-0.078|0.339||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.339|-0.078|0.218
91790364|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91521954|NCT04922554|182918784|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0233|||||||Log Rank|||||||0.0233
91594015|NCT06608368|183078844|SUPERIORITY||Least Square Mean Difference|-0.2639|STANDARD_ERROR_OF_MEAN|0.4455||0.5551|TWO_SIDED|95.0|-1.15|0.6221|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Test Dentifrice value.|||0.6221|-1.1500|0.5551
91521955|NCT04922554|182918785|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0349|||||||Log Rank|||||||0.0349
91521956|NCT03810534|182918804|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|3.24||0.62|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.62
91521957|NCT03810534|182918805|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.44||0.31|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.31
91521958|NCT03810534|182918806|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.33||0.93|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.93
91521959|NCT03810534|182918807|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.34||0.6|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.60
91521960|NCT03810534|182918808|SUPERIORITY||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|3.49||0.53|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.53
91521961|NCT03810534|182918809|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|3.57||0.83|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.83
91594016|NCT06608368|183078844|SUPERIORITY||Least Square Mean Difference|-0.5044|STANDARD_ERROR_OF_MEAN|0.4555||0.2714|TWO_SIDED|95.0|-1.4104|0.4016|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice value.|||0.4016|-1.4104|0.2714
91594017|NCT06608368|183078844|SUPERIORITY||Least Square Mean Difference|-0.2404|STANDARD_ERROR_OF_MEAN|0.4402||0.5864|TWO_SIDED|95.0|-1.116|0.6351|||Mixed Model with Repeated Measures||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|||0.6351|-1.1160|0.5864
91594018|NCT06608368|183078847|SUPERIORITY||Least Square Mean Difference|-0.3597|STANDARD_ERROR_OF_MEAN|0.4238||0.3984|TWO_SIDED|95.0|-1.2026|0.4831|||ANCOVA||Least Square Mean Difference was calculated as Positive Control Dentifrice minus Test Dentifrice value.|||0.4831|-1.2026|0.3984
91594019|NCT06608368|183078847|SUPERIORITY||Least Square Mean Difference|-0.3827|STANDARD_ERROR_OF_MEAN|0.4277||0.3734|TWO_SIDED|95.0|-1.2332|0.4678|||ANCOVA||Least Square Mean Difference was calculated as Positive Control Dentifrice value minus Reference Dentifrice.|||0.4678|-1.2332|0.3734
91783070|NCT04845568|183445823|SUPERIORITY||Mean Difference (Net)|-1.19|STANDARD_ERROR_OF_MEAN|1.56||0.453|TWO_SIDED|95.0|-4.39|2.02||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Healthy Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for healthy eating does not differ between conditions.||2.02|-4.39|0.453
91783071|NCT04845568|183445824|SUPERIORITY||Mean Difference (Net)|0.275|STANDARD_ERROR_OF_MEAN|0.3||0.368|TWO_SIDED|95.0|-0.342|0.892||A priori threshold for statistical significance set at p\< 0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness to Change Child's Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in readiness for healthy eating does not differ between conditions.||.892|-.342|.368
91783072|NCT04845568|183445824|SUPERIORITY||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.34||0.714|TWO_SIDED|95.0|-0.575|0.827||A priori threshold for statistical significance set at p\< .05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions to help child improve physical activity from baseline to two-week follow up does not differ between conditions.||.827|-.575|.714
91783073|NCT04845568|183445825|SUPERIORITY||Mean Difference (Net)|-0.522|STANDARD_ERROR_OF_MEAN|1.88||0.783|TWO_SIDED|95.0|-4.39|3.34||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child attitudes toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child attitudes toward healthy eating from baseline to post-intervention does not differ between conditions.||3.34|-4.39|.783
91783074|NCT04845568|183445825|SUPERIORITY||Mean Difference (Net)|-1.99|STANDARD_ERROR_OF_MEAN|1.97||0.323|TWO_SIDED|95.0|-6.05|2.07||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intentions toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child intentions toward healthy eating from baseline to post-intervention does not differ between conditions.||2.07|-6.05|.323
91783075|NCT04845568|183445825|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.89||0.276|TWO_SIDED|95.0|-1.79|6.01||A priori threshold for statistical significance is set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in caregiver intentions toward helping their child engage in healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions from baseline to post-intervention does not differ between conditions.||6.01|-1.79|.276
91783076|NCT04845568|183445826|SUPERIORITY||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.4||0.547|TWO_SIDED|95.0|-0.59|1.08||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fruits. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fruit servings per week from baseline to two-week follow up does not differ between conditions.||1.08|-.59|.547
91783077|NCT04845568|183445826|SUPERIORITY||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.42||0.99|TWO_SIDED|95.0|-0.87|0.86||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of vegetables. It is an independent samples t test. It is testing the null hypothesis that the mean change in child vegetable servings per week from baseline to two-week follow up does not differ between conditions.||.86|-.87|.990
91783078|NCT04845568|183445826|SUPERIORITY||Mean Difference (Net)|-0.203|STANDARD_ERROR_OF_MEAN|0.32||0.527|TWO_SIDED|95.0|-0.86|0.45||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fast food. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fast food servings per week from baseline to two-week follow up does not differ between conditions.||.45|-.86|.527
91783079|NCT04845568|183445827|SUPERIORITY||Mean Difference (Net)|-0.159|STANDARD_ERROR_OF_MEAN|0.55||0.777|TWO_SIDED|95.0|-1.33|1.01||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child weekly intake of breakfast. It is an independent samples t test. It is testing the null hypothesis that the mean change in child breakfast meals per week from baseline to two-week follow up does not differ between conditions.||1.01|-1.33|.777
91790365|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.799|TWO_SIDED|95.0|-0.219|0.169||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.169|-0.219|0.799
91594020|NCT06608368|183078847|SUPERIORITY||Least Square Mean Difference|-0.02296|STANDARD_ERROR_OF_MEAN|0.4099||0.9555|TWO_SIDED|95.0|-0.8382|0.7923|||ANCOVA||Least Square Mean Difference was calculated as Test Dentifrice value minus Reference Dentifrice value.|||0.7923|-0.8382|0.9555
91594021|NCT03080883|183078855|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.3117|TWO_SIDED|95.0|0.38|1.37|||Gray Test P-value|||||1.37|0.38|0.3117
91594022|NCT03080883|183078856|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.4|2.53|||Gray Test P-value|||||2.53|0.40|0.9970
91594023|NCT01999465|183078880|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms.||||||0.40
91594024|NCT01999465|183078881|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
91594025|NCT01308008|183078887|SUPERIORITY||coefficient|0.05||||0.16|TWO_SIDED|95.0|-0.02|0.13|||Regression, Logistic|||||0.13|-0.02|0.16
91594026|NCT01308008|183078888|SUPERIORITY||coefficient|34.0||||0.17|TWO_SIDED|95.0|-15.0|83.0|||Regression, Logistic|||||83|-15|0.17
91594027|NCT01308008|183078889|SUPERIORITY||coefficient|-8.7||||0.5|TWO_SIDED|95.0|-35.0|17.0|||Regression, Logistic|||||17|-35|0.5
91594028|NCT02325219|183078890|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91594029|NCT02325219|183078890|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91594030|NCT02325219|183078891|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91594031|NCT02325219|183078891|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91594032|NCT02187172|183078937|SUPERIORITY||Mean Difference (Final Values)|-0.2456|STANDARD_ERROR_OF_MEAN|0.07||0.0012|TWO_SIDED|95.0|-0.3873|-0.104|||Regression, Linear|||Comparison during RCT period||-0.1040|-0.3873|0.0012
91594033|NCT02187172|183078937|SUPERIORITY||Mean Difference (Final Values)|-0.0151|STANDARD_ERROR_OF_MEAN|0.0353||0.6718|TWO_SIDED|95.0|-0.0867|0.0565|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.0565|-0.0867|0.6718
91594034|NCT02187172|183078938|SUPERIORITY||Mean Difference (Final Values)|-64.97|STANDARD_ERROR_OF_MEAN|44.88||0.1159|TWO_SIDED|95.0|-115.83|25.89|||Regression, Linear|||Comparison during RCT period||25.89|-115.83|0.1159
91594035|NCT02187172|183078938|SUPERIORITY||Mean Difference (Final Values)|6.65|STANDARD_ERROR_OF_MEAN|22.24||0.7666|TWO_SIDED|95.0|-38.41|51.72|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||51.72|-38.41|0.7666
91594036|NCT02187172|183078939|SUPERIORITY||Mean Difference (Final Values)|-80.89|STANDARD_ERROR_OF_MEAN|30.46||0.0115|TWO_SIDED|95.0|-142.55|-19.23|||Regression, Linear|||Comparison during RCT period||-19.23|-142.55|0.0115
91594037|NCT02187172|183078939|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|14.11||0.8883|TWO_SIDED|95.0|-30.58|26.59|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||26.59|-30.58|0.8883
91594038|NCT02187172|183078940|SUPERIORITY||Mean Difference (Final Values)|-3027.21|STANDARD_ERROR_OF_MEAN|3180.58||0.3472|TWO_SIDED|95.0|-9465.95|3411.54|||Regression, Linear|||Comparison during RCT period||3411.54|-9465.95|0.3472
91783080|NCT04845568|183445827|SUPERIORITY||Mean Difference (Net)|-0.736|STANDARD_ERROR_OF_MEAN|0.74||0.329|TWO_SIDED|95.0|-2.26|0.79||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of family dinners. It is an independent samples t test. It is testing the null hypothesis that the mean change in child family dinners per week from baseline to two-week follow up does not differ between conditions.||.79|-2.26|.329
91783081|NCT04845568|183445828|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.086|TWO_SIDED|95.0|-0.07|0.99||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child screentime. It is an independent samples t test. It is testing the null hypothesis that the mean change in child screentime per week from baseline to two-week follow up does not differ between conditions.||.99|-0.07|.086
91783082|NCT04845568|183445828|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.64|TWO_SIDED|95.0|-0.64|0.4||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child active hours. It is an independent samples t test. It is testing the null hypothesis that the mean change in child active hours per week from baseline to two-week follow up does not differ between conditions.||.40|-.64|.64
91783083|NCT00630838|183445829|SUPERIORITY_OR_OTHER||||||=|0.897|TWO_SIDED||||||t-test, 2 sided|||||||=0.897
91594039|NCT02187172|183078940|SUPERIORITY||Mean Difference (Final Values)|-1974.63|STANDARD_ERROR_OF_MEAN|1659.11||0.2416|TWO_SIDED|95.0|-5336.3|1387.04|||Regression, Linear|||Combined ustekinumab and placebo groups for active treatment period analysis.||1387.04|-5336.30|0.2416
91594040|NCT02187172|183078941|SUPERIORITY||Mean Difference (Final Values)|20.66|STANDARD_ERROR_OF_MEAN|24.75||0.6742|TWO_SIDED|95.0|-78.03|119.34|||Regression, Linear|||Comparison during RCT period||119.34|-78.03|0.6742
91594041|NCT02187172|183078941|SUPERIORITY||Mean Difference (Final Values)|47.0|STANDARD_ERROR_OF_MEAN|35.84||0.1979|TWO_SIDED|95.0|-25.63|11963.0|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||11963|-25.63|0.1979
91594042|NCT02187172|183078942|SUPERIORITY||Mean Difference (Final Values)|-7884.29|STANDARD_ERROR_OF_MEAN|7780.29||0.3173|TWO_SIDED|95.0|-23634.67|7566.1|||Regression, Linear|||Comparison during RCT period||7566.10|-23634.67|0.3173
91594043|NCT02187172|183078942|SUPERIORITY||Mean Difference (Final Values)|-3782.54|STANDARD_ERROR_OF_MEAN|4073.25||0.3591|TWO_SIDED|95.0|-12035.72|4470.64|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4470.64|-12035.72|0.3591
91594044|NCT02187172|183078943|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.54||0.9767|TWO_SIDED|95.0|-5.22|5.07|||Regression, Linear|||Comparison during RCT period||5.07|-5.22|0.9767
91594045|NCT02187172|183078943|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.09||0.3205|TWO_SIDED|95.0|-3.29|1.11|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.11|-3.29|0.3205
91594046|NCT02187172|183078944|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|19.96||0.4632|TWO_SIDED|95.0|-55.19|25.61|||Regression, Linear|||Comparison during RCT period||25.61|-55.19|0.4632
91594047|NCT02187172|183078944|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|11.47||0.5316|TWO_SIDED|95.0|-30.47|15.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||15.99|-30.47|0.5316
91594048|NCT02187172|183078945|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1928|TWO_SIDED|95.0|-2.27|0.47|||Regression, Linear|||Comparison during RCT period||0.47|-2.27|0.1928
91594049|NCT02187172|183078945|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-1.36|0.02|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.02|-1.36|0.0580
91594050|NCT02187172|183078946|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|11.41||0.7185|TWO_SIDED|95.0|-27.24|18.96|||Regression, Linear|||Comparison during RCT period||18.96|-27.24|0.7185
91594051|NCT02187172|183078946|SUPERIORITY||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|8.41||0.3271|TWO_SIDED|95.0|-25.4|8.69|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||8.69|-25.40|0.3271
91594052|NCT02187172|183078947|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.51||0.3124|TWO_SIDED|95.0|-1.56|0.51|||Regression, Linear|||Comparison during RCT period||0.51|-1.56|0.3124
91783084|NCT00256997|183445859|SUPERIORITY_OR_OTHER|||||||0.5498||||||P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale.|Cox proportional hazard model|||||||0.5498
91594053|NCT02187172|183078947|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0106|TWO_SIDED|95.0|-0.54|-0.08|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.08|-0.54|0.0106
91594054|NCT02187172|183078948|SUPERIORITY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|33.42||0.0408|TWO_SIDED|95.0|-138.42|-3.11|||Regression, Linear|||Comparison during RCT period||-3.11|-138.42|0.0408
91594055|NCT02187172|183078948|SUPERIORITY||Mean Difference (Final Values)|71.72|STANDARD_ERROR_OF_MEAN|132.87||0.5926|TWO_SIDED|95.0|-197.5|340.93|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||340.93|-197.50|0.5926
91594056|NCT02187172|183078949|SUPERIORITY||Mean Difference (Final Values)|191.49|STANDARD_ERROR_OF_MEAN|46.1||0.0002|TWO_SIDED|95.0|98.18|284.81|||Regression, Linear|||Comparison during RCT period||284.81|98.18|0.0002
91594057|NCT02187172|183078949|SUPERIORITY||Mean Difference (Final Values)|171.21|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001|TWO_SIDED|95.0|130.08|212.34|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||212.34|130.08|<0.0001
91521962|NCT03810534|182918810|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.05||0.75|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.75
91594058|NCT02187172|183078950|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.98||0.011|TWO_SIDED|95.0|-4.62|-0.64|||Regression, Linear|||Comparison during RCT period||-0.64|-4.62|0.0110
91594059|NCT02187172|183078950|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0008|TWO_SIDED|95.0|-1.79|-0.51|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.51|-1.79|0.0008
91594060|NCT02187172|183078951|SUPERIORITY||Mean Difference (Final Values)|-155.31|STANDARD_ERROR_OF_MEAN|688.28||0.8227|TWO_SIDED|95.0|-1548.66|1238.04|||Regression, Linear|||Comparison during RCT period||1238.04|-1548.66|0.8227
91594061|NCT02187172|183078951|SUPERIORITY||Mean Difference (Final Values)|-407.43|STANDARD_ERROR_OF_MEAN|180.7||0.0302|TWO_SIDED|95.0|-773.57|-41.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-41.29|-773.57|0.0302
91594062|NCT02187172|183078952|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|-0.47||0.2333|TWO_SIDED|95.0|-1.25|0.32|||Regression, Linear|||Comparison during RCT period||0.32|-1.25|0.2333
91783085|NCT04672655|183445879|OTHER|||||||0.8875||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.8875
91594063|NCT02187172|183078952|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0713|TWO_SIDED|95.0|-0.8|0.03|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.03|-0.80|0.0713
91783086|NCT04672655|183445880|OTHER|||||||0.4811||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.4811
91783087|NCT04672655|183445881|OTHER|||||||0.754||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.754
91783088|NCT04672655|183445882|OTHER|||||||0.0406||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.0406
91783089|NCT04672655|183445883|OTHER|||||||0.9032||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.9032
91783090|NCT01326104|183445884|SUPERIORITY||comparing two curves|0.286||||0.927|TWO_SIDED|90.0|0.107|0.764||This is the p-value comparing Group A with historical control.|Log Rank|One sample log rank.||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||0.764|0.107|0.927
91783091|NCT01326104|183445884|SUPERIORITY||compare two curves|0.0|||<|0.001|TWO_SIDED|||||This is the p-value comparing Group B with historical control.|Log Rank|||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||||<0.001
91783092|NCT01326104|183445884|SUPERIORITY||Comparing two curves|0.091|||<|0.001|TWO_SIDED|90.0|0.03|0.276||This is the p-value comparing Groups A and B combined with historical control.|Log Rank|||||0.276|0.03|<0.001
91783093|NCT01287741|183445890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4753|TWO_SIDED|95.0|0.78|1.12|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.12|0.78|0.4753
91783094|NCT01287741|183445891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2736|TWO_SIDED|95.0|0.72|1.1|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.10|0.72|0.2736
91783095|NCT03843541|183445906|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_DEVIATION|0.763|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||<0.001
91783096|NCT03843541|183445907|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_DEVIATION|0.783||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.002
91783097|NCT03843541|183445908|SUPERIORITY|||||||0.239|||||||Stratified Mann-Whitney U Statistic|||||||0.239
91783098|NCT03843541|183445909|SUPERIORITY|||||||0.037|||||||Stratified Mann-Whitney U Statistic|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.037
91783099|NCT03843541|183445910|SUPERIORITY|||||||0.093|||||||Stratified Mann Whitney U Statistic|||||||0.093
91783100|NCT03843541|183445910|SUPERIORITY|||||||0.118|||||||Stratified Mann Whitney U Statistic|||||||0.118
91783101|NCT03843541|183445911|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
91783102|NCT03843541|183445911|SUPERIORITY|||||||0.11|||||||Stratified Mann Whitney U Statistic|||||||0.110
91783103|NCT03843541|183445912|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
91783104|NCT03843541|183445912|SUPERIORITY|||||||0.402|||||||Stratified Mann Whitney U Statistic|||||||0.402
91648761|NCT01507831|183190186|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.0|||<|0.0001|TWO_SIDED|95.0|-58.3|-53.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.7|-58.3|<0.0001
91783105|NCT03843541|183445913|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5||||0.002|TWO_SIDED|97.5|0.43|1.0|||Modified Mann-Whitney U Statistic||The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.|||1.00|0.43|0.002
91783106|NCT03843541|183445914|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5|||<|0.001|TWO_SIDED|98.75|0.45|1.0|||Modified Mann-Whitney U Statistic||"The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.~."|||1.00|0.45|<0.001
91783107|NCT03843541|183445915|SUPERIORITY|||||||0.356|||||||Modified Mann-Whitney U Statistic|||||||0.356
91783108|NCT03843541|183445915|SUPERIORITY|||||||0.007|||||||Modified Mann-Whitney U Statistic|||||||0.007
91594064|NCT02187172|183078953|SUPERIORITY||Mean Difference (Final Values)|-16.87|STANDARD_ERROR_OF_MEAN|15.62||0.2869|TWO_SIDED|95.0|-48.48|14.75|||Regression, Linear|||Comparison during RCT period||14.75|-48.48|0.2869
91594065|NCT02187172|183078953|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|1.71||0.1988|TWO_SIDED|95.0|-5.69|1.22|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.22|-5.69|0.1988
91594066|NCT02187172|183078954|SUPERIORITY||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|12.91||0.8744|TWO_SIDED|95.0|-24.09|28.2|||Regression, Linear|||Comparison during RCT period||28.20|-24.09|0.8744
91594067|NCT02187172|183078954|SUPERIORITY||Mean Difference (Final Values)|10.55|STANDARD_ERROR_OF_MEAN|8.26||0.2093|TWO_SIDED|95.0|-6.18|27.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||27.29|-6.18|0.2093
91594068|NCT02187172|183078955|SUPERIORITY||Mean Difference (Final Values)|19.2|STANDARD_ERROR_OF_MEAN|7.41||0.0135|TWO_SIDED|95.0|4.21|34.2|||Regression, Linear|||Comparison during RCT period||34.20|4.21|0.0135
91594069|NCT02187172|183078955|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|4.14||0.8499|TWO_SIDED|95.0|-9.19|7.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||7.61|-9.19|0.8499
91594070|NCT02187172|183078956|SUPERIORITY||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.96||0.0693|TWO_SIDED|95.0|-0.3|7.62|||Regression, Linear|||Comparison during RCT period||7.62|-0.30|0.0693
91594071|NCT02187172|183078956|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.42||0.1841|TWO_SIDED|95.0|-0.96|4.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4.80|-0.96|0.1841
91594072|NCT02187172|183078957|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.03||0.2305|TWO_SIDED|95.0|-0.83|3.34|||Regression, Linear|||Comparison during RCT period||3.34|-0.83|0.2305
91594073|NCT02187172|183078957|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.72||0.2189|TWO_SIDED|95.0|-0.53|2.37|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.37|-0.53|0.2189
91783109|NCT03843541|183445916|SUPERIORITY|||||||0.38|||||||Modified Mann-Whitney U Statistic|||||||0.380
91783110|NCT03843541|183445916|SUPERIORITY|||||||0.018|||||||Modified Mann-Whitney U Statistic|||||||0.018
91594074|NCT02187172|183078958|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3212|TWO_SIDED|95.0|-0.34|0.11|||Regression, Linear|||Comparison during RCT period||0.11|-0.34|0.3212
91594075|NCT02187172|183078958|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0137|TWO_SIDED|95.0|0.04|0.31|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.31|0.04|0.0137
91594076|NCT02187172|183078959|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.6||0.8383|TWO_SIDED|95.0|-1.09|1.33|||Regression, Linear|||Comparison during RCT period||1.33|-1.09|0.8383
91594077|NCT02187172|183078959|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.36||0.1651|TWO_SIDED|95.0|-0.22|1.24|||Regression, Logistic|||Global change from baseline after 52 weeks of active treatment.||1.24|-0.22|0.1651
91648762|NCT01507831|183190187|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-56.6|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-52.6|-56.6|<0.0001
91783111|NCT03843541|183445917|SUPERIORITY|||||||0.366|||||||Modified Mann-Whitney U Statistic|||||||0.366
91783112|NCT03843541|183445917|SUPERIORITY|||||||0.027|||||||Modified Mann-Whitney U Statistic|||||||0.027
91783113|NCT03843541|183445918|SUPERIORITY|||||||0.052|||||||Modified Mann-Whitney U Statistic|||||||0.052
91783114|NCT03843541|183445918|SUPERIORITY|||||||0.058|||||||Modified Mann-Whitney U Statistic|||||||0.058
91783115|NCT03843541|183445919|SUPERIORITY|||||||0.309|||||||Modified Mann-Whitney U Statistic|||||||0.309
91783116|NCT03843541|183445919|SUPERIORITY|||||||0.006|||||||Modified Mann-Whitney U Statistic|||||||0.006
91521963|NCT03810534|182918811|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.07||0.5|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.50
91521964|NCT03810534|182918812|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5||0.48|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.48
91521965|NCT03810534|182918813|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.52||0.22|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.22
91521966|NCT03810534|182918814|SUPERIORITY||Mean ratio|0.96|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||.88
91521967|NCT03810534|182918815|SUPERIORITY||Mean ratio|0.72|STANDARD_ERROR_OF_MEAN|0.18||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||.23
91521968|NCT03092375|182918823|OTHER|Study is not intended to be powered|Mean Difference (Final Values)|-0.76|||||TWO_SIDED|95.0|-9.48|5.12|||||Excludes re-infection and death|The difference in the percentage of subjects with on-treatment virologic failure (Defined as increase of \>1 log10 IU/mL above nadir during treatment, or HCV RNA \>= 15 IU/mL at end of treatment with at least 6 weeks of treatment between Arms A and B are summarized with two-sided 95% Wilson score intervals.||5.12|-9.48|
91521969|NCT03092375|182918824|OTHER|The difference in the percentage of subjects with post-treatment relapse between Arms A and B are summarized with two-sided 95% Wilson score intervals.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.49|5.49||||||||5.49|-10.49|
91594078|NCT02187172|183078960|SUPERIORITY||Mean Difference (Final Values)|2.49|STANDARD_ERROR_OF_MEAN|1.7||0.1502|TWO_SIDED|95.0|-0.94|5.93|||Regression, Linear|||Comparison during RCT period||5.93|-0.94|0.1502
91521970|NCT03092375|182918825|OTHER|Difference in percentage of subjects with on-treatment virologic failure between Arms C and D will be summarized with two-sided 95% Wilson score intervals|Mean Difference (Final Values)|9.52|||||TWO_SIDED|95.0|-3.03|22.08||||||||22.08|-3.03|
91521971|NCT03092375|182918826|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-13.85|10.22||||||Excludes re-infection and death||10.22|-13.85|
91521972|NCT03092375|182918827|OTHER|Study was not powered to compare efficacy|Logistic Regression Contrast Estimate|-0.812||||0.161|TWO_SIDED|95.0|-1.947|0.323|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Comparison of Arm Pair A/C versus B/D overall on mITT population|||0.323|-1.947|0.161
91521973|NCT03092375|182918827|OTHER|Study is not powered to compare efficacy of 12 wks vs 16 weeks of treatment|Logistic regression contrast estimate|0.89||||0.89|TWO_SIDED|95.0|-1.239|1.076|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Difference in proportion of SVR12 rates for 12 vs 16 weeks on mITT Comparing Cirrhotic subjects versus non-cirrhotic subjects.|||1.076|-1.239|0.890
91521974|NCT03092375|182918827|OTHER|Study is not powered|Logistic regression contrast estimate|0.977||||0.265|TWO_SIDED|95.0|-0.74|2.694|||Chi-squared|||Comparison of 12 weeks vs 16 weeks in Genotype 1b vs non-1b||2.694|-0.740|0.265
91521975|NCT00861614|182918837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0127|TWO_SIDED|95.0|0.71|0.96|||Log Rank||Ipilimumab over placebo|||0.96|0.71|0.0127
91521976|NCT00861614|182918839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.61|0.82|||||Ipilimumab over placebo|||0.82|0.61|
91521977|NCT00861614|182918841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.02|4.0|||||Ipilimumab over placebo|||4.00|0.02|
91521978|NCT00944658|182918851|SUPERIORITY|||||||0.139|||||||ANCOVA|||||||0.139
91521979|NCT00944658|182918852|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
91521980|NCT00944658|182918853|SUPERIORITY|||||||0.108|||||||ANCOVA|Rank Ancova||||||0.108
91521981|NCT00605202|182918885|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value of the change in the plasma potassium (baseline to 2 weeks) between arms|t-test, 2 sided|||Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms||||0.007
91521982|NCT00838682|182918886|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91521983|NCT00838682|182918887|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91521984|NCT00838682|182918888|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91521985|NCT00838682|182918889|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91521986|NCT00838682|182918890|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91521987|NCT00838682|182918891|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91594079|NCT02187172|183078960|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.84||0.8054|TWO_SIDED|95.0|-1.49|1.91|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.91|-1.49|0.8054
91594080|NCT02187172|183078961|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.69||0.4235|TWO_SIDED|95.0|-4.79|2.05|||Regression, Linear|||Comparison during RCT period||2.05|-4.79|0.4235
91783117|NCT02930018|183445922|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.146||||0.335|TWO_SIDED|95.0|0.869|1.511||2 sided 0.05 significance level.|Regression, Logistic|||The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.||1.511|0.869|0.335
91783118|NCT02930018|183445923|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.024||||0.866|TWO_SIDED|95.0|0.781|1.342||2 sided 0.05 significance level.|Regression, Logistic|||||1.342|0.781|0.866
91783119|NCT02930018|183445924|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.776||||0.199|TWO_SIDED|95.0|0.527|1.143||2 sided 0.05 significance level.|Regression, Logistic|||||1.143|0.527|0.199
91521988|NCT02305381|182918892|SUPERIORITY_OR_OTHER||Treatment difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.01|-1.5|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.50|-2.01|< 0.0001
91521989|NCT02305381|182918892|SUPERIORITY_OR_OTHER||Treatment difference|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.1|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.10|-1.61|< 0.0001
91521990|NCT02276066|182918900|OTHER|We performed a delta analysis, by graphing the difference between the two measurements, we wanted to visually assess the degree of agreement or discrepancy between the two methods. We were looking to evaluate the consistency, accuracy, or bias between different measurement techniques.|||||<|0.05|||||||Delta analysis|||||||<0.05
91521991|NCT02943941|182918913|OTHER|||||||0.429|||||||ANOVA|||||||0.429
91521992|NCT02943941|182918914|OTHER|||||||0.059||||||Pressure during coughing versus normal breathing initially measured at baseline.|ANOVA|||||||0.059
91521993|NCT02943941|182918915|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91521994|NCT03286751|182918935|SUPERIORITY||Ratio of Geometric LSMeans|1.01||||0.5495|TWO_SIDED|95.0|0.974|1.05|||Mixed Models Analysis|||||1.05|0.974|0.5495
91521995|NCT03286751|182918935|SUPERIORITY||Ratio of Geometric LSMeans|1.02||||0.2236|TWO_SIDED|95.0|0.986|1.06|||Mixed Models Analysis|||||1.06|0.986|0.2236
91521996|NCT03286751|182918935|SUPERIORITY||Ratio of Geometric LSMeans|1.03||||0.0727|TWO_SIDED|95.0|0.997|1.07|||Mixed Models Analysis|||||1.07|0.997|0.0727
91521997|NCT03286751|182918936|SUPERIORITY||Ratio of Geometric LSMeans|0.97||||0.5749|TWO_SIDED|95.0|0.87|1.08|||Mixed Models Analysis|||||1.08|0.87|0.5749
91521998|NCT03286751|182918936|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1578|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1578
91521999|NCT03286751|182918936|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1351|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1351
91594081|NCT02187172|183078961|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.97||0.8653|TWO_SIDED|95.0|-1.8|2.13|||Regression, Linear|||Comparison during RCT period||2.13|-1.80|0.8653
91594082|NCT02187172|183078962|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.89||0.558|TWO_SIDED|95.0|-4.95|2.71|||Regression, Linear|||Comparison during RCT period||2.71|-4.95|0.5580
91594083|NCT02187172|183078962|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.0||0.4454|TWO_SIDED|95.0|-1.25|2.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.80|-1.25|0.4454
91594084|NCT02187172|183078963|SUPERIORITY||Mean Difference (Final Values)|21.37|STANDARD_ERROR_OF_MEAN|6.67||0.0027|TWO_SIDED|95.0|7.86|34.87|||Regression, Linear|||Comparison during RCT period||34.87|7.86|0.0027
91594085|NCT02187172|183078963|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|4.07||0.4775|TWO_SIDED|95.0|-11.17|5.33|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||5.33|-11.17|0.4775
91594086|NCT02187172|183078964|SUPERIORITY||Mean Difference (Final Values)|230.77|STANDARD_ERROR_OF_MEAN|69.8||0.0021|TWO_SIDED|95.0|89.47|372.08|||Regression, Linear|||Comparison during RCT period||372.08|89.47|0.0021
91594087|NCT02187172|183078964|SUPERIORITY||Mean Difference (Final Values)|-31.89|STANDARD_ERROR_OF_MEAN|41.71||0.4493|TWO_SIDED|95.0|-116.4|52.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||52.61|-116.40|0.4493
91594088|NCT02187172|183078965|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8008|TWO_SIDED|95.0|-0.3|0.38|||Regression, Linear|||Comparison during RCT period||0.38|-0.30|0.8008
91594089|NCT02187172|183078965|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.8068|TWO_SIDED|95.0|-0.19|0.24|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.24|-0.19|0.8068
91594090|NCT02187172|183078966|SUPERIORITY||Mean Difference (Final Values)|46.96|STANDARD_ERROR_OF_MEAN|56.12||0.4079|TWO_SIDED|95.0|-66.65|160.57|||Regression, Logistic|||Comparison during RCT period||160.57|-66.65|0.4079
91594091|NCT02187172|183078966|SUPERIORITY||Mean Difference (Final Values)|4.68|STANDARD_ERROR_OF_MEAN|33.85||0.8907|TWO_SIDED|95.0|-63.91|73.28|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||73.28|-63.91|0.8907
91594092|NCT02187172|183078967|SUPERIORITY||Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|48.81||0.8866|TWO_SIDED|95.0|-91.8|105.81|||Regression, Linear|||Comparison during RCT period||105.81|-91.80|0.8866
91594093|NCT02187172|183078967|SUPERIORITY||Mean Difference (Final Values)|-24.74|STANDARD_ERROR_OF_MEAN|32.59||0.4527|TWO_SIDED|95.0|-90.78|41.3|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||41.30|-90.78|0.4527
91648763|NCT01507831|183190188|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-40.4|-37.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.5|-40.4|<0.0001
91783120|NCT02930018|183445925|SUPERIORITY||Odds Ratio (OR)|1.657||||0.028|TWO_SIDED|95.0|1.055|2.603|||Regression, Logistic|||||2.603|1.055|0.028
91783121|NCT02930018|183445925|SUPERIORITY||Absolute Risk Difference (%)|9.6|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
91783122|NCT02930018|183445925|SUPERIORITY||Relative Risk Difference (%)|19.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
91783123|NCT02930018|183445926|SUPERIORITY||Odds Ratio (OR)|1.482||||0.088|TWO_SIDED|95.0|0.943|2.329|||Regression, Logistic|||||2.329|0.943|0.088
91783124|NCT02930018|183445926|SUPERIORITY||Absolute Risk Difference (%)|9.1|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
91783125|NCT02930018|183445926|SUPERIORITY||Relative Risk Difference (%)|18.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
91783126|NCT02930018|183445927|SUPERIORITY||Odds Ratio (OR)|0.572||||0.055|TWO_SIDED|95.0|0.323|1.013|||Regression, Logistic|||||1.013|0.323|0.055
91783127|NCT02930018|183445927|SUPERIORITY||Absolute Risk Difference (%)|7.5|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
91783128|NCT02930018|183445927|SUPERIORITY||Relative Risk Difference (%)|39.7|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
91594094|NCT02187172|183078968|SUPERIORITY||Mean Difference (Final Values)|194.69|STANDARD_ERROR_OF_MEAN|66.23||0.0056|TWO_SIDED|95.0|60.61|328.77|||Regression, Linear|||Comparison during RCT period||328.77|60.61|0.0056
91594095|NCT02187172|183078968|SUPERIORITY||Mean Difference (Final Values)|-29.16|STANDARD_ERROR_OF_MEAN|38.01||0.4478|TWO_SIDED|95.0|-106.17|47.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||47.85|-106.17|0.4478
91594096|NCT02187172|183078969|SUPERIORITY||Mean Difference (Final Values)|3.14|STANDARD_ERROR_OF_MEAN|2.81||0.2704|TWO_SIDED|95.0|-2.55|8.83|||Regression, Linear|||Comparison during RCT period||8.83|-2.55|0.2704
91594097|NCT02187172|183078969|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.41||0.295|TWO_SIDED|95.0|-1.36|4.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.36|-1.36|0.2950
91594098|NCT02187172|183078970|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|6.57||0.0149|TWO_SIDED|95.0|-30.03|-3.45|||Regression, Linear|||Comparison during RCT period||-3.45|-30.03|0.0149
91594099|NCT02187172|183078970|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.37||0.9734|TWO_SIDED|95.0|-6.93|6.71|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.71|-6.93|0.9734
91594100|NCT02187172|183078971|SUPERIORITY||Mean Difference (Net)|-9.21|STANDARD_ERROR_OF_MEAN|11.76||0.4384|TWO_SIDED|95.0|-33.03|14.6|||Regression, Linear|||Comparison during RCT period||14.60|-33.03|0.4384
91594101|NCT02187172|183078971|SUPERIORITY||Mean Difference (Final Values)|11.14|STANDARD_ERROR_OF_MEAN|7.33||0.1373|TWO_SIDED|95.0|-3.72|25.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||25.99|-3.72|0.1373
91594102|NCT02187172|183078972|SUPERIORITY||Mean Difference (Final Values)|-15.71|STANDARD_ERROR_OF_MEAN|5.77||0.0097|TWO_SIDED|95.0|-27.39|-4.03|||Regression, Linear|||Comparison during RCT period||-4.03|-27.39|0.0097
91594103|NCT02187172|183078972|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.07||0.8119|TWO_SIDED|95.0|-4.69|3.7|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.70|-4.69|0.8119
91594104|NCT02187172|183078973|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|4.57||0.9415|TWO_SIDED|95.0|-8.91|9.59|||Regression, Linear|||Comparison during RCT period||9.59|-8.91|0.9415
91594105|NCT02187172|183078973|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|2.43||0.4485|TWO_SIDED|95.0|-6.77|3.06|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.06|-6.77|0.4485
91594106|NCT02187172|183078974|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|5.16||0.988|TWO_SIDED|95.0|-10.37|10.53|||Regression, Linear|||Comparison during RCT period||10.53|-10.37|0.9880
91594107|NCT02187172|183078974|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|2.59||0.8836|TWO_SIDED|95.0|-4.86|5.63|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||5.63|-4.86|0.8836
91594108|NCT02187172|183078975|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.3||0.8321|TWO_SIDED|95.0|-2.91|2.36|||Regression, Linear|||Comparison during RCT period||2.36|-2.91|0.8321
91594109|NCT02187172|183078975|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0394|TWO_SIDED|95.0|0.12|4.48|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.48|0.12|0.0394
91783129|NCT02930018|183445928|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.887||||0.529|TWO_SIDED|95.0|0.612|1.286|||Regression, Logistic|||||1.286|0.612|0.529
91783130|NCT02930018|183445929|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.782||||0.181|TWO_SIDED|95.0|0.545|1.121|||Regression, Logistic|||||1.121|0.545|0.181
91783131|NCT02930018|183445930|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.05||||0.869|TWO_SIDED|95.0|0.588|1.874|||Regression, Logistic|||||1.874|0.588|0.869
91783132|NCT00479687|183445972|SUPERIORITY|||||||0.038||||||There was a single primary variable and the a-prior threshold for statistical significance was 0.05.|Mixed Models Analysis|mixed effects repeated measure model with baseline VAS, treatment, and week as fixed effects and subject nested within site as a random effect.||||||0.0380
91594110|NCT02187172|183078976|SUPERIORITY||Mean Difference (Final Values)|152.68|STANDARD_ERROR_OF_MEAN|43.76||0.0012|TWO_SIDED|95.0|64.07|241.23|||Regression, Linear|||Comparison during RCT period||241.23|64.07|0.0012
91594111|NCT02187172|183078976|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|25.7||0.9085|TWO_SIDED|95.0|-55.04|49.09|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||49.09|-55.04|0.9085
91594112|NCT02187172|183078977|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.1792|TWO_SIDED|95.0|-0.03|0.14|||Regression, Linear|||Comparison during RCT period||0.14|-0.03|0.1792
91594113|NCT02187172|183078977|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2559|TWO_SIDED|95.0|-0.03|0.1|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.10|-0.03|0.2559
91594114|NCT02187172|183078978|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2453|TWO_SIDED|95.0|-0.11|0.41|||Regression, Linear|||||0.41|-0.11|0.2453
91594115|NCT02187172|183078978|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1087|TWO_SIDED|95.0|-0.02|0.23|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.23|-0.02|0.1087
91594116|NCT02187172|183078979|SUPERIORITY||Mean Difference (Final Values)|48.43|STANDARD_ERROR_OF_MEAN|61.62||0.4368|TWO_SIDED|95.0|-76.31|173.16|||Regression, Linear|||Comparison during RCT period||173.16|-76.31|0.4368
91594117|NCT02187172|183078979|SUPERIORITY||Mean Difference (Final Values)|-49.56|STANDARD_ERROR_OF_MEAN|27.84||0.0833|TWO_SIDED|95.0|-105.97|6.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.85|-105.97|0.0833
91648764|NCT01507831|183190189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|51.6|99.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||99.1|51.6|<0.0001
91783133|NCT02840799|183445984|SUPERIORITY||Mean Difference (Final Values)|-0.1309108|STANDARD_ERROR_OF_MEAN|0.2619326||0.6191|TWO_SIDED|95.0|-0.6552259|0.3934043||A two-sided α=0.05 was determined by the power calculation.|t-test, 2 sided|t = -0.49979, df = 58. N=59 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.|Only participants that successfully crossed over were included in the t-test (N=59).|We considered an increase in peak VO2 of \~0.6 ml/kg/min to be the minimum clinically significant change. Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints with a two-sided α=0.05. PASS11157 was used to perform power calculations.||0.3934043|-0.6552259|0.6191
91783134|NCT02840799|183445984|SUPERIORITY||Slope|0.1||||0.711|TWO_SIDED|95.0|-0.043|0.62||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.62|-.043|0.711
91783135|NCT02840799|183445985|SUPERIORITY||Mean Difference (Final Values)|2.217657|STANDARD_ERROR_OF_MEAN|2.065196||0.2871|TWO_SIDED|95.0|-1.910612|6.3459261|||t-test, 2 sided|t = 1.0738, df = 62, p-value = 0.2871, N=63 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.||A two-sided α=0.05 was determined by the power calculation.||6.3459261|-1.910612|0.2871
91594118|NCT02187172|183078980|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.11||0.8036|TWO_SIDED|95.0|-2.52|1.97|||Regression, Linear|||Comparison during RCT period||1.97|-2.52|0.8036
91594119|NCT02187172|183078980|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.51||0.4608|TWO_SIDED|95.0|-0.65|1.4|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.40|-0.65|0.4608
91594120|NCT02187172|183078981|SUPERIORITY||Mean Difference (Final Values)|3320.58|STANDARD_ERROR_OF_MEAN|3414.9||0.337|TWO_SIDED|95.0|-3592.52|10233.67|||Regression, Linear|||Comparison during RCT period||10233.67|-3592.52|0.3370
91594121|NCT02187172|183078981|SUPERIORITY||Mean Difference (Final Values)|6926.25|STANDARD_ERROR_OF_MEAN|2257.84||0.004|TWO_SIDED|95.0|2351.43|11501.07|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||11501.07|2351.43|0.0040
91594122|NCT02187172|183078982|SUPERIORITY||Mean Difference (Final Values)|-68.95|STANDARD_ERROR_OF_MEAN|131.9||0.6042|TWO_SIDED|95.0|-335.97|198.08|||Regression, Linear|||Comparison during RCT period||198.08|-335.97|0.6042
91594123|NCT02187172|183078982|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|85.98||0.9267|TWO_SIDED|95.0|-182.18|166.26|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||166.26|-182.18|0.9267
91790366|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790367|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.098||0.406|TWO_SIDED|95.0|-0.273|0.111||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.111|-0.273|0.406
91594124|NCT02187172|183078983|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|5.18||0.4226|TWO_SIDED|95.0|-6.28|14.68|||Regression, Linear|||Comparison during RCT period||14.68|-6.28|0.4226
91594125|NCT02187172|183078983|SUPERIORITY||Mean Difference (Final Values)|3.41|STANDARD_ERROR_OF_MEAN|3.43||0.327|TWO_SIDED|95.0|-3.54|10.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||10.36|-3.54|0.3270
91594126|NCT02187172|183078984|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.52||0.7507|TWO_SIDED|95.0|-3.56|2.59|||Regression, Linear|||Comparison during RCT period||2.59|-3.56|0.7507
91594127|NCT02187172|183078984|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.89||0.9348|TWO_SIDED|95.0|-1.88|1.73|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.73|-1.88|0.9348
91594128|NCT02187172|183078985|SUPERIORITY||Difference of proportions|0.67||||0.0005|TWO_SIDED|95.0|0.45|0.89|||Chi-squared|||||0.89|0.45|0.0005
91594129|NCT02187172|183078985|OTHER|95% CI of proportion achieving PASI75 at end of study|Proportion|0.72|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
91594130|NCT02187172|183078986|SUPERIORITY||Difference of proportions|0.41||||0.0016|TWO_SIDED|95.0|0.2|0.62|||Chi-squared|||||0.62|0.20|0.0016
91594131|NCT02187172|183078986|OTHER|95% CI of proportion achieving PASI90 at end of study|Proportion|0.49|||||TWO_SIDED|95.0|0.32|0.65||||||||0.65|0.32|
91594132|NCT02187172|183078987|SUPERIORITY||Difference of proportions|0.53||||0.0005|TWO_SIDED|95.0|0.29|0.78|||Chi-squared|||Comparison during RCT period for binary Physician Global Assessment||0.78|0.29|0.0005
91594133|NCT02187172|183078987|OTHER|95% CI of proportion achieving PGA clear/almost clear at end of study|Proportion|0.46|||||TWO_SIDED|95.0|0.3|0.63||||||||0.63|0.30|
91648765|NCT01507831|183190190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|93.4|||<|0.0001|TWO_SIDED|95.0|66.1|132.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||132.0|66.1|<0.0001
91648766|NCT01507831|183190191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.6|||<|0.0001|TWO_SIDED|95.0|53.3|104.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||104.4|53.3|<0.0001
91648767|NCT01507831|183190192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|97.3|||<|0.0001|TWO_SIDED|95.0|68.2|138.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||138.9|68.2|<0.0001
91648768|NCT01507831|183190193|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-23.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.1|-28.1|<0.0001
91648769|NCT01507831|183190194|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|3.3|<0.0001
91783136|NCT02840799|183445985|SUPERIORITY||Slope|-2.12||||0.2935|TWO_SIDED|95.0|-6.12|1.88||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect. Randomization sequence was not included in the final model due to lack of evidence for a carry over effect. Phase 1 data for participants that did not crossover due to IDS were considered for the model (N=74).||1.88|-6.12|0.2935
91783137|NCT02840799|183445986|SUPERIORITY||Mean Difference (Final Values)|2.1859922|STANDARD_ERROR_OF_MEAN|1.578944||0.171|TWO_SIDED|95.0|-0.9674467|5.3392901||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3844, df=65, p=0.171. N=66 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossover correctly.||||5.3392901|-0.9674467|0.171
91783138|NCT02840799|183445986|SUPERIORITY||Slope|-2.51||||0.113|TWO_SIDED|95.0|-5.62|0.61||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.61|-5.62|0.113
91594134|NCT02187172|183078988|SUPERIORITY||Mean Difference (Final Values)|8.32|STANDARD_ERROR_OF_MEAN|6.3||0.1944|TWO_SIDED|95.0|-4.42|21.06|||Regression, Linear|||||21.06|-4.42|0.1944
91648770|NCT01507831|183190195|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-20.1|-14.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-14.6|-20.1|<0.0001
91648771|NCT01507831|183190196|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|1.6|4.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.2|1.6|<0.0001
91594135|NCT02187172|183078988|SUPERIORITY||Mean Difference (Final Values)|-12.33|STANDARD_ERROR_OF_MEAN|3.5||0.0011|TWO_SIDED|95.0|-19.4|-5.25|||Regression, Linear|||||-5.25|-19.40|0.0011
91594136|NCT02187172|183078989|SUPERIORITY||Mean Difference (Final Values)|-779.59|STANDARD_ERROR_OF_MEAN|1049.99||0.4628|TWO_SIDED|95.0|-2911.19|1352.01|||Regression, Linear|||||1352.01|-2911.19|0.4628
91594137|NCT02187172|183078989|SUPERIORITY||Mean Difference (Final Values)|-910.84|STANDARD_ERROR_OF_MEAN|729.96||0.2209|TWO_SIDED|95.0|-2395.95|574.27|||Regression, Linear|||||574.27|-2395.95|0.2209
91594138|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.4295|TWO_SIDED|95.0|-1.65|0.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 1||0.70|-1.65|0.4295
91594139|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.0586|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 1||0.04|-2.34|0.0586
91594140|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.0111|TWO_SIDED|95.0|-3.34|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 2||-0.43|-3.34|0.0111
91594141|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.0141|TWO_SIDED|95.0|-3.3|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 2||-0.37|-3.30|0.0141
91594142|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.0152|TWO_SIDED|95.0|-4.0|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 4||-0.43|-4.00|0.0152
91594143|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06||||0.001|TWO_SIDED|95.0|-4.86|-1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 4||-1.25|-4.86|0.0010
91783139|NCT02840799|183445987|SUPERIORITY||Mean Difference (Final Values)|2.776572|STANDARD_ERROR_OF_MEAN|3.99464||0.4905|TWO_SIDED|95.0|-5.264221|10.817366||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t = 0.69507, df=46, p=.4905. N=47 due to only analyzed participants that correctly crossovered.||||10.817366|-5.264221|0.4905
91783140|NCT02840799|183445987|SUPERIORITY||Slope|1.088||||0.796|TWO_SIDED|95.0|-7.3|9.48||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||9.48|-7.30|0.796
91783141|NCT02840799|183445988|SUPERIORITY||Mean Difference (Final Values)|-38.11189|STANDARD_ERROR_OF_MEAN|43.84245||0.4017|TWO_SIDED|95.0|-133.63637|57.41259|||t-test, 2 sided|t=-0.86929,, df=12, p=0.4017||||57.41259|-133.63637|0.4017
91783142|NCT02840799|183445988|SUPERIORITY||Slope|61.77||||0.183|TWO_SIDED|95.0|-34.15|157.69||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||157.69|-34.15|0.183
91783143|NCT02840799|183445989|SUPERIORITY||Mean Difference (Final Values)|0.202782|STANDARD_ERROR_OF_MEAN|0.202782||0.5636|TWO_SIDED|95.0|-0.4959279|0.9014918||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=0.58074, df=59, p=0.5636||||0.9014918|-0.4959279|0.5636
91783144|NCT02840799|183445989|SUPERIORITY||Slope|-0.3118||||0.361|TWO_SIDED|95.0|-0.99|0.37||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.37|-0.99|0.361
91648772|NCT01507831|183190197|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-27.4|-22.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.7|-27.4|<0.0001
91783145|NCT02840799|183445990|SUPERIORITY||Mean Difference (Final Values)|-0.1532142|STANDARD_ERROR_OF_MEAN|-0.1532142||0.7707|TWO_SIDED|95.0|-1.1998786|0.8934502||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t= -0.29271, df=61, p=0.7707||||0.8934502|-1.1998786|0.7707
91783146|NCT02840799|183445990|SUPERIORITY||Slope|0.18872||||0.724|TWO_SIDED|95.0|-0.88|1.25||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||1.25|-0.88|0.724
91783147|NCT02840799|183445991|SUPERIORITY||Mean Difference (Final Values)|0.3262821|STANDARD_ERROR_OF_MEAN|0.2333465||0.1680825|TWO_SIDED|95.0|-0.1421806|0.7947447||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3983, df=51, p=0.1681||||0.7947447|-0.1421806|0.1680825
91783148|NCT02840799|183445991|SUPERIORITY||Slope|-0.4082||||0.093|TWO_SIDED|95.0|-0.88|0.07||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.07|-0.88|0.0930
91783149|NCT02840799|183445992|SUPERIORITY||Mean Difference (Final Values)|-2.116437|STANDARD_ERROR_OF_MEAN|1.176768||0.07984|TWO_SIDED|95.0|-4.4966754|0.2638017||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided||t = -1.7985, df=39, p=0.07984|||0.2638017|-4.4966754|0.07984
91783150|NCT02840799|183445992|SUPERIORITY||Slope|1.68||||0.135|TWO_SIDED|95.0|-0.54|3.9||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||3.90|-0.54|0.135
91783151|NCT02840799|183445993|SUPERIORITY||Mean Difference (Final Values)|-0.0192733|STANDARD_ERROR_OF_MEAN|0.01295984||0.145|TWO_SIDED|95.0|-0.0454871|0.0069404||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||0.00694040|-0.0454871|0.1450
91783152|NCT02840799|183445993|SUPERIORITY||Slope|0.01324||||0.3047|TWO_SIDED|95.0|-0.01|0.04||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.04|-0.01|0.3047
91783153|NCT02840799|183445994|SUPERIORITY||Mean Difference (Final Values)|-3.506681|STANDARD_ERROR_OF_MEAN|4.494971||0.44|TWO_SIDED|95.0|-12.598617|5.585256||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||5.585256|-12.598617|0.44
91522000|NCT01301391|182918946|SUPERIORITY||Single proportion|0.54|||<|0.001|TWO_SIDED|95.0|0.33|0.74||A priori threshold for statistical significance = 0.05|Fisher Exact|||H0:p≤ 25% vs H1:p\> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If \>=4 successes out of the first 15 patients are observed, accrual will continue up to 30.||0.74|0.33|<0.001
91783154|NCT02840799|183445994|SUPERIORITY||Slope|3.39106||||0.39911|TWO_SIDED|95.0|-4.66|11.44||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||11.44|-4.66|0.39911
91522001|NCT00106184|182918961|SUPERIORITY_OR_OTHER||||||=|0.74|TWO_SIDED||||||Log Rank|No confidence intervals as no parameters were estimated.||Proportional hazards model||||=0.74
91783155|NCT02642315|183446011|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
91783156|NCT02642315|183446012|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
91783157|NCT03860818|183446063|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Rate of inpatient hospitalization during study||||<.001
91783158|NCT03860818|183446063|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
91783159|NCT03860818|183446064|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Statistical analysis applies to all rows.||||||<0.001
91783160|NCT03860818|183446065|SUPERIORITY|||||||0.9064|||||||Chi-squared|||||||0.9064
91783161|NCT03860818|183446066|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
91783162|NCT00505778|183446071|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|1.3||||0.5016|TWO_SIDED|95.0|-2.3|4.9|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.9|-2.3|0.5016
91790368|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91783163|NCT00505778|183446072|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.8||||0.5426|TWO_SIDED|95.0|-1.8|3.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||3.5|-1.8|0.5426
91783164|NCT00505778|183446073|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.0||||0.977|TWO_SIDED|95.0|-4.6|4.7|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.7|-4.6|0.9770
91783165|NCT00505778|183446074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4726|TWO_SIDED|95.0|0.762|1.796|||Log Rank|Stratified by prior Asacol dose Category||||1.796|0.762|0.4726
91783166|NCT00505778|183446075|SUPERIORITY_OR_OTHER||Difference BID-QD in Least Square Mean|-0.45||||0.1753|TWO_SIDED|95.0|-1.09|0.2|||ANOVA|ANOVA with prior Asacol dose category as factor.||||0.20|-1.09|0.1753
91522002|NCT00106184|182918962|SUPERIORITY_OR_OTHER||||||>|0.9|TWO_SIDED|95.0|||||Chi-squared|Difference in baseline muscle enzymes therefore tested the difference in the proportions adjusting for the baseline values.||||||>0.90
91522003|NCT00106184|182918963|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Log Rank|||||||>0.90
91522004|NCT01814748|182918980|SUPERIORITY_OR_OTHER||Difference in least squares means|0.12||||0.535|TWO_SIDED|95.0|-0.26|0.49|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||0.49|-0.26|0.535
91522005|NCT01814748|182918981|SUPERIORITY_OR_OTHER||Difference in percent|-0.4|||||TWO_SIDED|95.0|-13.8|13.0||||||||13.0|-13.8|
91522006|NCT01814748|182918982|SUPERIORITY_OR_OTHER||Difference in percent|-2.0||||||||||||||||||
91522007|NCT01814748|182918983|SUPERIORITY_OR_OTHER||Difference in least squares means|4.2||||0.685|TWO_SIDED|95.0|-16.1|24.4|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||24.4|-16.1|0.685
91522008|NCT01814748|182918984|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.586|TWO_SIDED|95.0|-17.1|9.7|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||9.7|-17.1|0.586
91522009|NCT01814748|182918985|SUPERIORITY_OR_OTHER||Between-group rate difference|-0.4|||||TWO_SIDED|95.0|-14.0|13.1|||Mietinnen and Nurminen|||||13.1|-14.0|
91522010|NCT01814748|182918986|SUPERIORITY_OR_OTHER||Between-group rate difference|4.0|||||TWO_SIDED|95.0|-7.4|15.5|||Mietinnen and Nurminen|||||15.5|-7.4|
91522011|NCT00409682|182918996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.29||||0.075|TWO_SIDED|95.0|-3.14|23.71||There is no adjustment for multiple comparison on the primary outcome measure.|Cochran-Mantel-Haenszel||Difference is between adalimumab High-dose and adalimumab Low-dose group.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.||23.71|-3.14|0.075
91522012|NCT00409682|182918997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.18||||0.1|TWO_SIDED|95.0|-2.62|22.97||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||22.97|-2.62|0.100
91522013|NCT00409682|182918998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.72||||0.073|TWO_SIDED|95.0|-3.45|24.89||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||24.89|-3.45|0.073
91594144|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.0245|TWO_SIDED|95.0|-4.5|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 6||-0.31|-4.50|0.0245
91594145|NCT00880399|183078990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0082|TWO_SIDED|95.0|-4.97|-0.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 6||-0.75|-4.97|0.0082
91594146|NCT00880399|183078992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.51|TWO_SIDED|95.0|0.8|3.19|||Log Rank|||Placebo Vs Orvepitant 30 mg at Week 6||3.19|0.80|0.51
91594147|NCT00880399|183078992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.37|TWO_SIDED|95.0|0.84|3.3|||Log Rank|||Placebo Vs Orvepitant 60 mg at Week 6||3.30|0.84|0.37
91594148|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.7859|TWO_SIDED|95.0|-0.72|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.55|-0.72|0.7859
91594149|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.15||||0.6429|TWO_SIDED|95.0|-0.79|0.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.49|-0.79|0.6429
91594150|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.0092|TWO_SIDED|95.0|-1.82|-0.26|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.26|-1.82|0.0092
91594151|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.023|TWO_SIDED|95.0|-1.69|-0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.13|-1.69|0.0230
91648773|NCT01507831|183190198|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||6.8|4.3|<0.0001
91648774|NCT01507831|183190199|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-20.5|-15.3||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.3|-20.5|<0.0001
91648775|NCT01507831|183190200|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|2.8|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|2.8|<0.0001
91783167|NCT00505778|183446076|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|Difference BID-QD Remission Rates|3.6||||0.1557|TWO_SIDED|95.0|-1.3|8.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||8.5|-1.3|0.1557
91783168|NCT03436082|183446077|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.04|||||||Chi-squared|||||||0.04
91783169|NCT03436082|183446079|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.85|||||||Chi-squared|||||||0.85
91783170|NCT02917642|183446081|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.||||0.04
91783171|NCT02917642|183446082|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.||||0.94
91783172|NCT01864603|183446083|OTHER||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Comparison of Phase 1 arms||1.17|0.77|
91783173|NCT01864603|183446084|OTHER||Rate ratio|0.26|||||TWO_SIDED|95.0|0.09|0.75||||||||0.75|0.09|
91783174|NCT02136069|183446110|SUPERIORITY||Adjusted Difference in Remission Rates|-0.9||||0.8114||95.0|-8.7|6.83|||Cochran-Mantel-Haenszel|||||6.83|-8.70|0.8114
91783175|NCT02136069|183446111|NON_INFERIORITY|with margin -12.5%|Adjusted Difference in Remission Rates|-12.0||||0.1293|TWO_SIDED|95.0|-20.5|-3.26||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|A Farrington-Manning non-inferiority test was used to determine the nominal p-value.||||-3.26|-20.50|0.1293
91783176|NCT02136069|183446112|SUPERIORITY||Adjusted Difference in Remission Rates|-3.4||||0.4056|TWO_SIDED|95.0|-11.53|4.74||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|||||4.74|-11.53|0.4056
91783177|NCT02136069|183446113|SUPERIORITY||Adjusted Difference in Remission Rates|-2.4||||0.4591|TWO_SIDED|95.0|-8.88|4.14||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.14|-8.88|0.4591
91594152|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.0104|TWO_SIDED|95.0|-2.27|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.31|-2.27|0.0104
91594153|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.001|TWO_SIDED|95.0|-2.67|-0.69|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.69|-2.67|0.0010
91594154|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.0361|TWO_SIDED|95.0|-2.37|-0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.08|-2.37|0.0361
91594155|NCT00880399|183078993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54||||0.0092||95.0|-2.69|-0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.38|-2.69|0.0092
91594156|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.1662|TWO_SIDED|95.0|-1.74|0.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.30|-1.74|0.1662
91594157|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.2116|TWO_SIDED|95.0|-1.69|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.38|-1.69|0.2116
91594158|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02||||0.082|TWO_SIDED|95.0|-2.17|0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.13|-2.17|0.0820
91594159|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.3498|TWO_SIDED|95.0|-1.71|0.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.61|-1.71|0.3498
91594160|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.0107|TWO_SIDED|95.0|-2.99|-0.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.40|-2.99|0.0107
91783178|NCT02136069|183446114|SUPERIORITY||Adjusted Difference in Remission Rates|5.3||||0.4196|TWO_SIDED|95.0|-7.54|18.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||18.13|-7.54|0.4196
91783179|NCT02136069|183446115|SUPERIORITY||Adjusted Difference in Response Rates|-12.4||||0.0118|TWO_SIDED|95.0|-21.84|-2.66||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-2.66|-21.84|0.0118
91594161|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.0017|TWO_SIDED|95.0|-3.4|-0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.79|-3.40|0.0017
91783180|NCT02136069|183446116|SUPERIORITY||Adjusted Difference in Response Rates|-4.9||||0.2845|TWO_SIDED|95.0|-13.76|4.12||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.12|-13.76|0.2845
91783181|NCT02136069|183446117|SUPERIORITY||Adjusted Difference in Response Rates|-6.3||||0.1234|TWO_SIDED|95.0|-14.3|1.84||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||1.84|-14.30|0.1234
91783182|NCT02136069|183446118|SUPERIORITY||Adjusted Difference in Remission Rates|-5.0||||0.2168|TWO_SIDED|95.0|-12.84|2.94||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.94|-12.84|0.2168
91783183|NCT02136069|183446119|SUPERIORITY||Adjusted Difference in Response Rates|-9.5||||0.0564|TWO_SIDED|95.0|-19.06|0.29||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||0.29|-19.06|0.0564
91783184|NCT02136069|183446120|SUPERIORITY||Adjusted Difference in Response Rates|-6.0||||0.1729|TWO_SIDED|95.0|-14.51|2.7||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.70|-14.51|0.1729
91783185|NCT02136069|183446121|SUPERIORITY||Adjusted Difference in Remission Rates|-0.8||||0.8941|TWO_SIDED|95.0|-12.01|10.68||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||10.68|-12.01|0.8941
91783186|NCT02136069|183446130|SUPERIORITY|Week 10|Difference in Adjusted Means|-3.1||||0.4106|TWO_SIDED|95.0|-10.6|4.3||p-value has not been adjusted for multiplicity|ANCOVA|||||4.3|-10.6|0.4106
91783187|NCT02136069|183446130|SUPERIORITY|Week 30|Difference in Adjusted Means|-5.7||||0.1434|TWO_SIDED|95.0|-13.3|1.9||p-value has not been adjusted for multiplicity|ANCOVA|||||1.9|-13.3|0.1434
91783188|NCT02136069|183446130|SUPERIORITY|Week 54|Difference in Adjusted Means|-6.1||||0.1103|TWO_SIDED|95.0|-13.6|1.4||p-value has not been adjusted for multiplicity|ANCOVA|||||1.4|-13.6|0.1103
91783189|NCT04154189|183446150|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0396|TWO_SIDED|95.0|0.27|1.08||One-sided P value|Log Rank||Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.|||1.08|0.27|0.0396
91783190|NCT04154189|183446151|OTHER|Difference in PFS rates, and 2-sided 95% confidence intervals (CIs): CI and p-value constructed using the difference of the 2 Kaplan-Meier PFS rates (4 months) and the 2 corresponding Greenwood standard errors.|Difference in Percentage|10.2||||0.1683|TWO_SIDED|95.0|-10.6|31.1||One-sided P value|Kaplan-Meier Method|||||31.1|-10.6|0.1683
91783191|NCT04154189|183446153|OTHER||Hazard Ratio (HR)|0.93||||0.3924|TWO_SIDED|95.0|0.53|1.62||Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.|Stratified Log-rank One-sided Test||Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.|||1.62|0.53|0.3924
91783192|NCT04154189|183446154|OTHER|Difference and 95% CI: difference of 2 Kaplan-Meier OS-1y rates and corresponding Greenwood standard errors.|Difference in Percentage|-22.9||||0.0352|TWO_SIDED|95.0|-47.6|1.9||One-sided P value|Kaplan Meier Method|||||1.9|-47.6|0.0352
91783193|NCT04154189|183446155|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|7.7|||||TWO_SIDED|95.0|-6.4|22.3||||||||22.3|-6.4|
91783194|NCT04154189|183446156|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|5.2|||||TWO_SIDED|95.0|-10.3|20.0||||||||20.0|-10.3|
91783195|NCT01056016|183446162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.4|||=|0.003|TWO_SIDED||||||t-test, 2 sided|||The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.||||=.003
91783196|NCT04758637|183446190|SUPERIORITY||Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0|2.4|13.59||The calculated p-value is 7.62E-10.|Zero-inflated Poisson mixed regression|Model estimates were used to derive estimated difference in difference value. Confidence intervals were bootstrapped using 1000 repetitions.||Null hypothesis is the difference in difference in estimated mean pill counts from the last week of baseline (week 26) to the last week of the intervention period (week 53) between control and non-fatal is 0.||13.59|2.4|0
91783197|NCT04758637|183446190|SUPERIORITY||Mean Difference (Final Values)|-14.65||||0|TWO_SIDED|95.0|-25.14|-6.97||The calculated p-value is 2E-16.|Zero-inflated Poisson mixed regression|Model estimates were used to derive estimated difference in difference value. Confidence intervals were bootstrapped using 1000 repetitions.||Null hypothesis is the difference in difference in estimated means from the study start (week 0) to the study end (week 23) between control and fatal is 0.||-6.97|-25.14|0
91783198|NCT04758637|183446191|SUPERIORITY||Slope|0.72||||0.219|TWO_SIDED|95.0|-0.43|1.86|||Regression, Logistic|||||1.86|-0.43|0.219
91783199|NCT04758637|183446191|SUPERIORITY||Slope|-0.72||||0.229|TWO_SIDED|95.0|-1.9|0.46|||Regression, Logistic|||||0.46|-1.9|0.229
91783200|NCT01354314|183446193|SUPERIORITY|||||||0.893|||||||Regression, Linear|||||||0.893
91783201|NCT01354314|183446193|SUPERIORITY|||||||0.594|||||||Regression, Linear|||||||0.594
91783202|NCT01354314|183446193|SUPERIORITY|||||||0.712|||||||Regression, Linear|||||||0.712
91783203|NCT01354314|183446194|SUPERIORITY|||||||0.673|||||||Regression, Linear|||||||0.673
91594162|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.088|TWO_SIDED|95.0|-2.78|0.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.19|-2.78|0.0880
91594163|NCT00880399|183078994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.0282|TWO_SIDED|95.0|-3.17|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.18|-3.17|0.0282
91594164|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9854|TWO_SIDED|95.0|-0.45|0.44|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.44|-0.45|0.9854
91594165|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3476|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.23|-0.66|0.3476
91648776|NCT01455545|183190213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.967|TWO_SIDED|95.0|0.962|1.037|||Regression, Logistic|||Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.||1.037|0.962|0.967
91594166|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0898|TWO_SIDED|95.0|-0.94|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.07|-0.94|0.0898
91648777|NCT01455545|183190214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001||||0.861|TWO_SIDED|95.0|0.985|1.018|||Regression, Logistic|||||1.018|0.985|0.861
91783204|NCT01354314|183446194|SUPERIORITY|||||||0.153|||||||Regression, Linear|||||||0.153
91783205|NCT01354314|183446194|SUPERIORITY|||||||0.282|||||||Regression, Linear|||||||0.282
91783206|NCT01354314|183446195|SUPERIORITY|||||||0.327|||||||Regression, Linear|||||||0.327
91783207|NCT01354314|183446195|SUPERIORITY|||||||0.178|||||||Regression, Linear|||||||0.178
91783208|NCT01354314|183446195|SUPERIORITY|||||||0.48|||||||Regression, Linear|||||||0.480
91783209|NCT01354314|183446196|SUPERIORITY|||||||0.267|||||||Regression, Linear|||||||0.267
91783210|NCT01354314|183446196|SUPERIORITY|||||||0.368|||||||Regression, Linear|||||||0.368
91783211|NCT01354314|183446196|SUPERIORITY|||||||0.672|||||||Regression, Linear|||||||0.672
91783212|NCT05019521|183446226|SUPERIORITY||Least square (LS) mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0413||0.9205|TWO_SIDED|90.0|-0.01|0.126|||Mixed Models Analysis|||||0.126|-0.010|0.9205
91783213|NCT05019521|183446226|SUPERIORITY||LS mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0425||0.9205|TWO_SIDED|90.0|-0.086|0.055|||Mixed Models Analysis|||||0.055|-0.086|0.9205
91783214|NCT05019521|183446226|SUPERIORITY||LS mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.0422||0.9205|TWO_SIDED|90.0|-0.033|0.106|||Mixed Models Analysis|||||0.106|-0.033|0.9205
91783215|NCT02721966|183446255|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
91783216|NCT02721966|183446255|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.41|6.1|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||6.10|2.41|<.0001
91783217|NCT02721966|183446256|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
91783218|NCT02721966|183446257|SUPERIORITY||Odds Ratio (OR)|4.71|||<|0.0001|TWO_SIDED|95.0|2.67|8.33|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.67|<.0001
91783219|NCT02721966|183446257|SUPERIORITY||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.2|9.84|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|9.84|3.20|<.0001
91783220|NCT02721966|183446258|SUPERIORITY||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.43|8.33|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.43|<.0001
91594167|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0928|TWO_SIDED|95.0|-0.95|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.07|-0.95|0.0928
91594168|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2937|TWO_SIDED|95.0|-0.93|0.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.28|-0.93|0.2937
91783221|NCT02721966|183446258|SUPERIORITY||Odds Ratio (OR)|5.57|||<|0.0001|TWO_SIDED|95.0|3.04|10.21|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|10.21|3.04|<.0001
91783222|NCT02721966|183446259|SUPERIORITY||LS Mean of Treatment Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.62|<|0.0001|TWO_SIDED|95.0|-20.0|-9.7|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.0|<.0001
91783223|NCT02721966|183446259|SUPERIORITY||LS Mean of Treatment Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.59|<|0.0001|TWO_SIDED|95.0|-18.0|-7.8|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-7.8|-18.0|<.0001
91790369|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.099||0.363|TWO_SIDED|95.0|-0.285|0.105||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.105|-0.285|0.363
91594169|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.0587|TWO_SIDED|95.0|-1.2|0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.02|-1.20|0.0587
91594170|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.195|TWO_SIDED|95.0|-1.14|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.23|-1.14|0.1950
91594171|NCT00880399|183078995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.0498|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.00|-1.40|0.0498
91594172|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.1731|TWO_SIDED|95.0|0.72|6.4|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 1||6.40|0.72|0.1731
91594173|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.77||||0.7084|TWO_SIDED|95.0|0.2|2.97|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 1||2.97|0.20|0.7084
91594174|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.6||||0.0247|TWO_SIDED|95.0|1.13|5.98|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 2||5.98|1.13|0.0247
91594175|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||0.1862|TWO_SIDED|95.0|0.75|4.3|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 2||4.30|0.75|0.1862
91594176|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.87||||0.063|TWO_SIDED|95.0|0.97|3.61|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 4||3.61|0.97|0.0630
91648778|NCT01455545|183190215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.625||||0.252|TWO_SIDED|95.0|0.706|3.739|||Chi-squared|||Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square||3.739|0.706|0.252
91594177|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1413|TWO_SIDED|95.0|0.85|3.23|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 4||3.23|0.85|0.1413
91594178|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0806|TWO_SIDED|95.0|0.93|3.37|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 6||3.37|0.93|0.0806
91648779|NCT01455545|183190216|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Chi - square||||0.217
91648780|NCT01455545|183190217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.643|TWO_SIDED|95.0|0.376|1.829|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square||1.829|0.376|0.643
91783224|NCT02721966|183446260|SUPERIORITY||LS Mean of Treatment Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|95.0|-20.4|-9.7|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.4|<.0001
91783225|NCT02721966|183446260|SUPERIORITY||LS Mean of Treatment Difference|-15.0|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-20.3|-9.8|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.8|-20.3|<.0001
91783226|NCT02721966|183446261|SUPERIORITY||LS Mean of Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0971|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate.|0.1|-1.1|0.0971
91783227|NCT02721966|183446261|SUPERIORITY||LS Mean of Treatment Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0207|TWO_SIDED|95.0|-1.3|-0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-0.1|-1.3|0.0207
91783228|NCT02721966|183446262|SUPERIORITY||LS Mean of Treatment Difference|-0.175|STANDARD_ERROR_OF_MEAN|0.0502||0.0005|TWO_SIDED|95.0|-0.273|-0.076|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.076|-0.273|0.0005
91783229|NCT02721966|183446262|SUPERIORITY||LS Mean of Treatment Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0497|<|0.0001|TWO_SIDED|95.0|-0.331|-0.136|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.136|-0.331|<.0001
91783230|NCT02721966|183446263|SUPERIORITY||LS Mean of Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.01||0.0002|TWO_SIDED|95.0|1.8|5.7|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.7|1.8|0.0002
91594179|NCT00880399|183078996|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.53||||0.2007|TWO_SIDED|95.0|0.8|2.92|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 6||2.92|0.80|0.2007
91594180|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2523|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.07|-0.25|0.2523
91594181|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2639|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.07|-0.25|0.2639
91594182|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.0004|TWO_SIDED|95.0|-0.58|-0.17|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.17|-0.58|0.0004
91648781|NCT01455545|183190218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.155|TWO_SIDED|95.0|0.247|1.253|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.253|0.247|0.155
91648782|NCT01455545|183190219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19||||0.107|TWO_SIDED|95.0|0.02|1.763|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.763|0.020|0.107
91648783|NCT01455545|183190220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.849||||0.196|TWO_SIDED|95.0|1.541|2.219|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||2.219|1.541|0.196
91648784|NCT01455545|183190221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135||||0.15|TWO_SIDED|95.0|0.618|15.91|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||15.91|0.618|0.150
91648785|NCT01455545|183190222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.096||||0.822|TWO_SIDED|95.0|0.492|2.441|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.||2.441|0.492|0.822
91648786|NCT01455545|183190223|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91648787|NCT01455545|183190223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.005|TWO_SIDED|95.0|1.012|1.065|||Regression, Logistic|||||1.065|1.012|0.005
91648788|NCT01455545|183190224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.013|TWO_SIDED|95.0|0.153|0.799|||Regression, Logistic|||Ho = no differences between both groups H1= there are differences between both groups.||0.799|0.153|0.013
91648789|NCT03276962|183190293|SUPERIORITY||Incremental vaccine efficacy|-21.0||||0.154|TWO_SIDED|95.0|-57.0|7.0|||Regression, Cox|The 95% Confidence Interval of the incremental vaccine efficacy estimates was calculated from Cox regression model.||To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.||7|-57|0.154
91648790|NCT03056001|183190327|OTHER|Estimation only.|Rate|0.0333|||||TWO_SIDED|95.0|0.0008|0.1722|||||Confidence interval estimated using the Clopper Pearson method.|The reported severe or life-threatening adverse event rate with weekly doxorubicin and dacarbazine was 0.55. If it became evident that the rate of severe or life-threatening toxicity convincingly exceeded 0.55, the study would have been halted. Convincing evidence of exceeding 0.55 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.75 or higher.||0.1722|0.0008|
91648791|NCT03056001|183190328|OTHER|Estimation only|Median|1.3|||||TWO_SIDED|95.0|0.8|2.1|||||The Kaplan Meier method was used to estimate the median OS (in years) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||2.1|0.8|
91648792|NCT03056001|183190329|OTHER|Estimation only|Median|5.7|||||TWO_SIDED|95.0|4.1|8.3|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||8.3|4.1|
91648793|NCT03056001|183190330|OTHER|Estimation only.|Rate|0.367|||||TWO_SIDED|95.0|0.199|0.561|||||Confidence interval estimated using the Clopper Pearson method.|||0.561|0.199|
91648794|NCT03056001|183190331|OTHER|Estimation only|Median|8.0|||||TWO_SIDED|95.0|2.8|34.6|||||The Kaplan Meier method was used to estimate the median DoR (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median duration of response.|||34.6|2.8|
91783231|NCT02721966|183446263|SUPERIORITY||LS Mean of Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|0.99||0.0007|TWO_SIDED|95.0|1.4|5.3|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.3|1.4|0.0007
91783232|NCT02721966|183446264|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.5|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.5|<.0001
91783233|NCT02721966|183446264|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.4|<.0001
91783234|NCT02721966|183446265|SUPERIORITY||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.31|9.95|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|9.95|3.31|<.0001
91783235|NCT02721966|183446265|SUPERIORITY||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.83|8.16|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|8.16|2.83|<.0001
91790370|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91648795|NCT03567239|183190379|OTHER|"The PIADS is broken into 3 subgroups - Competence, Adaptability, and Self-Esteem. The minimum possible score is -3 and the maximum possible score is 3 for each subgroup - with positive 3 being the best. The 7-Point Likert scale was used in response to the question The device provided increased my ability to … in relation to the custom need they had. A response of 1 = Strongly disagree and 7 = strongly agree."|||||||||||||||||Median values: Overall = 2.42, Competence = 2.58, Adaptability = 2.33, Self-Esteem = 2.00, Likert = 7|||
91648796|NCT03567239|183190380|OTHER|||||||||||||||||The NASA Task Load Index ranges from 1 to 21 with the lower the score the better.|Median vales: Overall = 4.83, Mental demand = 11, Physical demand = 4, Temporal demand = 6, Performance = 3, Effort = 3, Frustration = 5.|||
91783236|NCT02840461|183446275|EQUIVALENCE|Therapeutic equivalence of the Test product to the Reference product based on the primary endpoint was evaluated in the PP population. If the confidence interval is within 80-125% for the primary endpoint, then the Test and Reference treatments are considered therapeutically equivalent.|Mean Difference (Net)|103.51|||||TWO_SIDED|90.0|97.95|110.0||||||||110.00|97.95|
91783237|NCT02840461|183446275|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0027|TWO_SIDED|95.0|-16.24|-3.42|||ANOVA|||||-3.42|-16.24|0.0027
91594183|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.0348|TWO_SIDED|95.0|-0.43|-0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.02|-0.43|0.0348
91594184|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.0166|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.06|-0.62|0.0166
91594185|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.0014|TWO_SIDED|95.0|-0.75|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.18|-0.75|0.0014
91594186|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.0099|TWO_SIDED|95.0|-0.79|-0.11|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.11|-0.79|0.0099
91594187|NCT00880399|183078997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.0059|TWO_SIDED|95.0|-0.83|-0.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.14|-0.83|0.0059
91783238|NCT02840461|183446275|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0028|TWO_SIDED|95.0|-16.25|-3.4|||ANOVA|||||-3.40|-16.25|0.0028
91594188|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.5473|TWO_SIDED|95.0|-2.04|1.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.08|-2.04|0.5473
91594189|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9814|TWO_SIDED|95.0|-1.56|1.6|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.60|-1.56|0.9814
91594190|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.0515|TWO_SIDED|95.0|-3.03|0.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.01|-3.03|0.0515
91648797|NCT03567239|183190381|OTHER|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.||||||||||||||||The QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) evaluates a patient's satisfaction with various assistive technologies. It has two subgroups, Device and Service on a scale of 1-5 with 5 being the best score.|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.|||
91594191|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.468|TWO_SIDED|95.0|-2.09|0.96|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.96|-2.09|0.4680
91594192|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.1757|TWO_SIDED|95.0|-2.98|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.55|-2.98|0.1757
91783239|NCT02840461|183446276|EQUIVALENCE|If the 90% confidence interval (with Yates correction) for the difference between the proportion of patients in the Test and Reference groups considered to be a clinical success was contained within the pre-defined equivalence limits \[-20%, +20%\], the therapeutic equivalence of the Test to Reference product was considered supported.|Mean Difference (Net)|5.8|||||TWO_SIDED|90.0|-2.7|14.2||||||||14.2|-2.7|
91783240|NCT04301193|183446290|OTHER||Correlation - R value|0.93|||<|0.05|TWO_SIDED||||||Regression, Linear|||Using standard techniques for estimating sample size, a Delong's test indicated that a total of 61 samples would be sufcient to detect a 0.2 increase in the AUROC from the null hypothesis 0.5, assuming an alpha level of 5% and 90% power \[12\]. The manuscript was referenced against the STROBE checklist for cohort studies. Descriptive statistics were used to present.||||<0.05
91783241|NCT04301193|183446290|OTHER||Correlation - R value|0.77|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
91790371|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.125||0.22|TWO_SIDED|95.0|-0.4|0.093||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.093|-0.400|0.220
91790372|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790373|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.123||0.245|TWO_SIDED|95.0|-0.386|0.099||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.099|-0.386|0.245
91790374|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790375|NCT02880956|183460061|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.127||0.569|TWO_SIDED|95.0|-0.323|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.178|-0.323|0.569
91594193|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.2048|TWO_SIDED|95.0|-2.93|0.63|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.63|-2.93|0.2048
91594194|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.0312|TWO_SIDED|95.0|-4.12|-0.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.20|-4.12|0.0312
91790376|NCT02880956|183460061|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790377|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.093||0.945|TWO_SIDED|95.0|-0.177|0.19||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.190|-0.177|0.945
91790378|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91594195|NCT00880399|183078998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0202|TWO_SIDED|95.0|-4.31|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.37|-4.31|0.0202
91594196|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.45||||0.7246|TWO_SIDED|95.0|-20.38|29.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 1||29.28|-20.38|0.7246
91594197|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.36||||0.0332|TWO_SIDED|95.0|2.2|52.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 1||52.52|2.20|0.0332
91594198|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.12||||0.5439|TWO_SIDED|95.0|-18.18|34.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 2||34.41|-18.18|0.5439
91783242|NCT04193189|183446342|NON_INFERIORITY|Pre-specified non-inferiority margin (2-CpG minus 3-alum): -10%.|Common proportion difference|12.5|||||TWO_SIDED|97.5|4.1|20.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||20.9|4.1|
91594199|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.52||||0.3127|TWO_SIDED|95.0|-12.8|39.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 2||39.85|-12.80|0.3127
91594200|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.51||||0.2419|TWO_SIDED|95.0|-46.9|11.89|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 4||11.89|-46.90|0.2419
91783243|NCT04193189|183446342|SUPERIORITY||Common proportion difference|18.4|||||TWO_SIDED|97.5|10.4|26.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe repeated confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||26.2|10.4|
91783244|NCT04193189|183446342|SUPERIORITY||Common proportion difference|6.0|||||TWO_SIDED|97.5|-0.2|11.8|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Secondary objective of Group A||11.8|-0.2|
91783245|NCT04193189|183446344|SUPERIORITY||Common proportion difference|9.0|||||TWO_SIDED|97.5|0.1|18.1|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 4 weeks post last scheduled vaccination (Week 8 in 2-CpG, Week 28 in 3-alum)||18.1|0.1|
91783246|NCT04193189|183446344|SUPERIORITY||Common proportion difference|19.0|||||TWO_SIDED|97.5|10.0|27.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 12 in 2-CpG, Week 32 in 3-alum)||27.9|10.0|
91783247|NCT04193189|183446344|SUPERIORITY||Common proportion difference|27.8|||||TWO_SIDED|97.5|17.7|37.2|||||Common SP proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 28 in 2-CpG, Week 48 in 3-alum)||37.2|17.7|
91783248|NCT04193189|183446344|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|21.3|42.3|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 52 in 2-CpG, Week 72 in 3-alum)||42.3|21.3|
91594201|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Median Difference (Net)|21.11||||0.1606|TWO_SIDED|95.0|-8.43|50.64|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 4||50.64|-8.43|0.1606
91783249|NCT04193189|183446344|SUPERIORITY||Common proportion difference|23.8|||||TWO_SIDED|97.5|15.5|32.3|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 32)||32.3|15.5|
91783250|NCT04193189|183446344|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|23.2|41.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 48)||41.2|23.2|
91783251|NCT04193189|183446344|SUPERIORITY||Common proportion difference|38.8|||||TWO_SIDED|97.5|28.9|48.1|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 72)||48.1|28.9|
91594202|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.48||||0.7412||95.0|-22.21|31.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 6||31.16|-22.21|0.7412
91594203|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.47||||0.3974|TWO_SIDED|95.0|-15.19|38.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 6||38.14|-15.19|0.3974
91594204|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.52||||0.1397|TWO_SIDED|95.0|-26.83|3.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 1||3.79|-26.83|0.1397
91594205|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9||||0.0026|TWO_SIDED|95.0|-39.4|-8.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 1||-8.41|-39.40|0.0026
91594206|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67||||0.3206|TWO_SIDED|95.0|-22.85|7.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 2||7.50|-22.85|0.3206
91594207|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.67||||0.0015|TWO_SIDED|95.0|-39.86|-9.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 2||-9.49|-39.86|0.0015
91594208|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.71||||0.2157|TWO_SIDED|95.0|-27.7|6.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 4||6.28|-27.70|0.2157
91594209|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.31||||0.0784|TWO_SIDED|95.0|-32.37|1.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 4||1.75|-32.37|0.0784
91594210|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.84||||0.3345|TWO_SIDED|95.0|-7.09|20.78|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 6||20.78|-7.09|0.3345
91783252|NCT04193189|183446344|SUPERIORITY||Common proportion difference|10.0|||||TWO_SIDED|97.5|3.1|16.4|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 4 weeks post last scheduled vaccination (Week 28 in 3-CpG, Week 8 in 2-CpG)||16.4|3.1|
91783253|NCT04193189|183446344|SUPERIORITY||Common proportion difference|4.8|||||TWO_SIDED|97.5|-0.8|10.5|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 8 weeks post last scheduled vaccination (Week 32 in 3-CpG, Week 12 in 2-CpG)||10.5|-0.8|
91783254|NCT04193189|183446344|SUPERIORITY||Common proportion difference|4.9|||||TWO_SIDED|97.5|-0.8|11.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 24 weeks post last scheduled vaccination (Week 48 in 3-CpG, Week 28 in 2-CpG)||11.2|-0.8|
91783255|NCT04193189|183446344|SUPERIORITY||Common proportion difference|7.2|||||TWO_SIDED|97.5|0.7|14.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 48 weeks post last scheduled vaccination (Week 72 in 3-CpG, Week 52 in 2-CpG)||14.2|0.7|
91783256|NCT03036215|183446365|OTHER||Mean Difference (Net)|-7.0|||||TWO_SIDED|||||||||Pilot study, no power analysis applicable; no statistical test||||
91783257|NCT03036215|183446366|OTHER|pilot study; no statistical test performed|Mean Difference (Net)|1.0|||||TWO_SIDED|||||||||Pilot study; no statistical test run||||
91783258|NCT03036215|183446367|OTHER||Mean Difference (Net)|-5.2|||||TWO_SIDED|||||||||Pilot study; no statistical test for significance run||||
91783259|NCT01474239|183446378|SUPERIORITY_OR_OTHER|||||||0.4291|TWO_SIDED|||||Statistical significance was assessed with a one-sided alpha error of 10 percent (%).|Exact Binomial Test|||The 6-month OS rate (OS-6) for bevacizumab was compared to the expected proportion of 0.60 under null hypothesis (ineffective treatment) with the application of the exact binomial test. The one-tailed statistical hypotheses was p0 less than or equal to (≤) 0.60 (null hypothesis) versus pA greater than or equal to (≥) 0.77 (alternative hypothesis), where p is the estimated probability of survival at 6 months.||||0.4291
91783260|NCT01243242|183446394|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using the median test for independent samples|Median|||For the primary endpoint (CAARS change), median test was applied as the primary analysis due to outlier numbers observed ; secondary analysis of the primary endpoint utilized ANCOVA with adjustment to age, gender and site (which is usually expected to influence the endpoint) as well as baseline values. Additional parametric T-test was applied, but was found less effective due to outlier values.||||0.0093
91783261|NCT01243242|183446395|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age|ANCOVA|||Analysis of Covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) and to Visits 3 through 5 in the primary endpoint, CAARS, and secondary endpoint scales, CGI-S, TOVA and AAQoL between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0195
91594211|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.25||||0.6471|TWO_SIDED|95.0|-17.19|10.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 6||10.70|-17.19|0.6471
91783262|NCT01243242|183446396|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age.|ANCOVA|||Analysis of covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0093
91594212|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.8071|TWO_SIDED|95.0|-16.95|21.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 1||21.75|-16.95|0.8071
91594213|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.3564|TWO_SIDED|95.0|-29.11|10.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 1||10.52|-29.11|0.3564
91594214|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.86||||0.122|TWO_SIDED|95.0|-36.0|4.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 2||4.28|-36.00|0.1220
91594215|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.25||||0.0313|TWO_SIDED|95.0|-42.49|-2.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 2||-2.01|-42.49|0.0313
91594216|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.15||||0.8861|TWO_SIDED|95.0|-27.45|31.76|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 4||31.76|-27.45|0.8861
91594217|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.9132|TWO_SIDED|95.0|-31.87|28.53|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 4||28.53|-31.87|0.9132
91594218|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.09||||0.7844|TWO_SIDED|95.0|-33.55|25.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||25.37|-33.55|0.7844
91594219|NCT00880399|183078999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.8497|TWO_SIDED|95.0|-27.33|33.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||33.14|-27.33|0.8497
91594220|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4814|TWO_SIDED|95.0|-0.83|0.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.39|-0.83|0.4814
91594221|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.6179|TWO_SIDED|95.0|-0.47|0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.79|-0.47|0.6179
91648798|NCT02766400|183190398|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d effect size at 12 months|0.53|||<|0.001|TWO_SIDED|95.0|-0.12|1.19||a priori threshold was set at p\<0.05|Linear mixed models|F(4,150)=5.11|Effect size was calculated using mean change scores (baseline to month 12) and standard error of change (baseline to month 12) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||1.19|-0.12|<0.001
91709214|NCT01402986|183311364|SUPERIORITY_OR_OTHER||Rate Ratio|0.8||||0.365|TWO_SIDED|95.0|0.5|1.29|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.29|0.50|0.365
91783263|NCT03983317|183446398|OTHER|We tested if the average drinks consumed was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.026|||||||t-test, 2 sided|Paired t-test||||||0.026
91594222|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.5022|TWO_SIDED|95.0|-0.44|0.21|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.21|-0.44|0.5022
91594223|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.1389|TWO_SIDED|95.0|-0.57|0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.08|-0.57|0.1389
91594224|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9663|TWO_SIDED|95.0|-0.36|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.38|-0.36|0.9663
91594225|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.1311|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.09|-0.67|0.1311
91783264|NCT03983317|183446400|OTHER|We tested if the average craving intensity was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.001|||||||t-test, 2 sided|Paired t-test||||||0.001
91783265|NCT00662675|183446403|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-fat as a covariate.||The power calculation was based on the assumption that the true mean difference between the active and the placebo group was 31.2% with a common standard deviation of 22.6% using a 2-sided, 2-sample, t-test with a 5% significance level.||||<0.001
91783266|NCT00662675|183446404|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-protein(nitrogen) as a covariate.|ANCOVA|||||||<0.001
91783267|NCT01256294|183446414|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02|||||TWO_SIDED|95.0|0.96|1.09||||||||1.09|0.96|
91783268|NCT01256294|183446414|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02||||0.486|TWO_SIDED|90.0|0.97|1.08||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of AUC0-12h were assessed relative to the interval \[80%, 125%\].||1.08|0.97|0.486
91783269|NCT01256294|183446419|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09|||||TWO_SIDED|95.0|1.0|1.2|||||Ratio of geometric means: Generic tacrolimus/Branded tacrolimus|||1.20|1.00|
91783270|NCT01256294|183446419|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09||||0.057|TWO_SIDED|90.0|1.01|1.18||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of Cmax were assessed relative to the interval \[80%, 125%\].||1.18|1.01|0.057
91783271|NCT01621802|183446455|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.98|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.98|-0.72|
91594226|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.1362|TWO_SIDED|95.0|-0.73|0.1|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.10|-0.73|0.1362
91783272|NCT01621802|183446455|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.71|||||TWO_SIDED|97.5|0.02|2.97|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||2.97|0.02|
91783273|NCT01621802|183446456|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.97|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.97|-0.72|
91783274|NCT01621802|183446456|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
91783275|NCT01621802|183446457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO group minus pooled Com\_MMR\_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|-0.14|||||TWO_SIDED|97.5|-0.98|1.84|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.84|-0.98|
91783276|NCT01621802|183446457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
91783277|NCT01621802|183446458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.99|||||TWO_SIDED|97.5|0.92|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.92|
91783278|NCT01621802|183446458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.96|1.1|||ANCOVA|Ancova model: adjustment for baseline concentration country - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.10|0.96|
91783279|NCT01621802|183446459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.0|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.00|0.83|
91783280|NCT01621802|183446459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.96|||||TWO_SIDED|97.5|0.87|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.87|
91790379|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.092||0.974|TWO_SIDED|95.0|-0.184|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.178|-0.184|0.974
91594227|NCT00880399|183079000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.0275|TWO_SIDED|95.0|-0.91|-0.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.05|-0.91|0.0275
91594228|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.0606|TWO_SIDED|95.0|-0.02|1.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 1||1.06|-0.02|0.0606
91594229|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.0132|TWO_SIDED|95.0|0.15|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 1||1.24|0.15|0.0132
91594230|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.001|TWO_SIDED|95.0|0.38|1.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 2||1.50|0.38|0.0010
91594231|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.0034|TWO_SIDED|95.0|0.28|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 2||1.40|0.28|0.0034
91783281|NCT01621802|183446460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.97|1.09|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|Adjusted geometric mean concentration (GMC) ratio (Inv\_MMR\_CO group divided by Com\_MMR\_CO group) for antibodies to rubella virus.||1.09|0.97|
91783282|NCT01621802|183446460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.95|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.07|0.95|
91783283|NCT04857320|183446481|SUPERIORITY|||||||1.6e-05|||||||ANOVA|Degrees of Freedom = 5||Glucose was monitored by means of a wearable Continuous Glucose Monitor for several days prior to, during and post dosing. Measurements were gathered for each subject and averaged within-subject data. Our null hypothesis was that post prandial serum glucose would not vary significantly from their baseline values.||||0.000016
91783284|NCT04857320|183446482|SUPERIORITY|||||||0|||||||t-test, 1 sided|Degrees of Freedom = 3||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0
91783285|NCT04857320|183446482|SUPERIORITY|||||||3e-06|||||||t-test, 1 sided|||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0.000003
91783286|NCT04857320|183446482|SUPERIORITY|||||||2e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000002
91783287|NCT04857320|183446482|SUPERIORITY|||||||3.5e-05|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000035
91783288|NCT04857320|183446482|SUPERIORITY|||||||4e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000004
91783289|NCT04857320|183446483|SUPERIORITY|||||||0|||||||ANOVA|||||||0
91783290|NCT01149148|183446487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3333|STANDARD_DEVIATION|1.626||0.678|TWO_SIDED|95.0|-1.36|2.02||A prior threshold for statistical significance is p \< 0.05|t-test, 2 sided||The difference between baseline and three months is (baseline - 3 month). The difference in control and intervention is (intervention - control), which in this case is (unblinded - blinded).|The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.||2.02|-1.36|0.678
91783291|NCT02249832|183446497|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|||||<|0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||<0.001
91783292|NCT02249832|183446498|EQUIVALENCE|A significance level of 0.05 was used (two-sided).|||||<|0.001|||||||ANOVA|||A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||<0.001
91783293|NCT02249832|183446499|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||||0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.001
91783294|NCT02914301|183446513|OTHER|We compared outcomes between study arms using t-tests for continuous outcomes.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91783295|NCT04881942|183446585|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|89.44||||0.0184|TWO_SIDED|95.0|15.77|163.11|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham)|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||163.11|15.77|0.0184
91790380|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91783296|NCT04881942|183446585|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|195.7|||<|0.0001|TWO_SIDED|95.0|122.01|269.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||269.38|122.01|<.0001
91783297|NCT04881942|183446585|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|168.83|||<|0.0001|TWO_SIDED|95.0|95.17|242.5|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||242.50|95.17|<.0001
91783298|NCT04881942|183446585|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|182.65|||<|0.0001|TWO_SIDED|95.0|108.63|256.67|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||256.67|108.63|<.0001
91783299|NCT04881942|183446588|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5972.3|||<|0.0001|TWO_SIDED|95.0|4191.1|7753.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7753.6|4191.1|<.0001
91783300|NCT04881942|183446588|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6099.5|||<|0.0001|TWO_SIDED|95.0|4317.8|7881.2|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7881.2|4317.8|<.0001
91783301|NCT04881942|183446588|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6484.7|||<|0.0001|TWO_SIDED|95.0|4701.7|8267.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||8267.6|4701.7|<.0001
91783302|NCT04881942|183446588|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5366.8|||<|0.0001|TWO_SIDED|95.0|3575.9|7157.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7157.7|3575.9|<.0001
91594232|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.6692|TWO_SIDED|95.0|-0.47|0.72|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 4||0.72|-0.47|0.6692
91783303|NCT04881942|183446591|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.17||||0.915|TWO_SIDED|95.0|-2.92|3.25|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.25|-2.92|0.9150
91783304|NCT04881942|183446591|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.35||||0.8217|TWO_SIDED|95.0|-2.7|3.4|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.40|-2.70|0.8217
91783305|NCT04881942|183446591|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|21.11|||<|0.0001|TWO_SIDED|95.0|18.06|24.16|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||24.16|18.06|<.0001
91783306|NCT04881942|183446591|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|31.01|||<|0.0001|TWO_SIDED|95.0|27.91|34.12|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||34.12|27.91|<.0001
91783307|NCT04881942|183446594|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1678.4||||0.0031|TWO_SIDED|95.0|592.14|2764.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2764.6|592.14|.0031
91783308|NCT04881942|183446594|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1199.7||||0.031|TWO_SIDED|95.0|113.74|2285.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2285.7|113.74|.0310
91783309|NCT04881942|183446594|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|3354.5|||<|0.0001|TWO_SIDED|95.0|2266.6|4442.3|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||4442.3|2266.6|<.0001
91783310|NCT04881942|183446594|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|2511.0|||<|0.0001|TWO_SIDED|95.0|1416.1|3605.9|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3605.9|1416.1|<.0001
91790381|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.094||0.963|TWO_SIDED|95.0|-0.19|0.181||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||||0.181|-0.190|0.963
91594233|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.82||||0.0078|TWO_SIDED|95.0|0.22|1.42|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 4||1.42|0.22|0.0078
91594234|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66||||0.044|TWO_SIDED|95.0|0.02|1.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 6||1.30|0.02|0.0440
91594235|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0181|TWO_SIDED|95.0|0.13|1.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 6||1.41|0.13|0.0181
91594236|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.1484|TWO_SIDED|95.0|-0.14|0.92|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 1||0.92|-0.14|0.1484
91594237|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.0108|TWO_SIDED|95.0|0.16|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 1||1.24|0.16|0.0108
91594238|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.0361||95.0|0.04|1.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 2||1.16|0.04|0.0361
91594239|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.0418|TWO_SIDED|95.0|0.02|1.15|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 2||1.15|0.02|0.0418
91594240|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9305|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 4||0.58|-0.64|0.9305
91648799|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.04819|STANDARD_ERROR_OF_MEAN|0.02482||0.0535|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total POQ Score as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0535
91783311|NCT04881942|183446597|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0002|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|.0002
91783312|NCT04881942|183446597|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0003|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|0.0003
91783313|NCT04881942|183446597|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.47|0.21|<.0001
91783314|NCT04881942|183446597|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.43|0.17|<.0001
91783315|NCT04881942|183446604|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Final Values)|0.035|||<|0.0001|TWO_SIDED|95.0|0.031|0.039|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.039|0.031|<.0001
91783316|NCT04881942|183446604|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.034|||<|0.0001|TWO_SIDED|95.0|0.03|0.038|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.038|0.030|<.0001
91783317|NCT04881942|183446604|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.04|||<|0.0001|TWO_SIDED|95.0|0.036|0.044|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.044|0.036|<.0001
91790382|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91594241|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0141|TWO_SIDED|95.0|0.16|1.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 4||1.39|0.16|0.0141
91594242|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.0562|TWO_SIDED|95.0|-0.02|1.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.31|-0.02|0.0562
91594243|NCT00880399|183079001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.0296|TWO_SIDED|95.0|0.07|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.40|0.07|0.0296
91594244|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.0735|TWO_SIDED|95.0|-0.21|4.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||4.61|-0.21|0.0735
91594245|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35||||0.2905|TWO_SIDED|95.0|-1.17|3.86|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||3.86|-1.17|0.2905
91594246|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.05||||0.4327|TWO_SIDED|95.0|-1.6|3.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||3.70|-1.60|0.4327
91594247|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.4642|TWO_SIDED|95.0|-1.73|3.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||3.75|-1.73|0.4642
91594248|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48||||0.285|TWO_SIDED|95.0|-1.26|4.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||4.23|-1.26|0.2850
91594249|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.5984|TWO_SIDED|95.0|-2.08|3.59|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||3.59|-2.08|0.5984
91594250|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21||||0.4192|TWO_SIDED|95.0|-1.76|4.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||4.19|-1.76|0.4192
91594251|NCT00880399|183079005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.6766|TWO_SIDED|95.0|-2.42|3.71|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||3.71|-2.42|0.6766
91594252|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9951|TWO_SIDED|95.0|-1.26|1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.25|-1.26|0.9951
91594253|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.894|TWO_SIDED|95.0|-1.17|1.34|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.34|-1.17|0.8940
91709215|NCT01402986|183311364|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.922|TWO_SIDED|95.0|0.56|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.68|0.56|0.922
91783318|NCT04881942|183446604|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.037|||<|0.0001|TWO_SIDED|95.0|0.033|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.033|<.0001
91783319|NCT04881942|183446605|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.031|0.04|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.040|0.031|<.0001
91783320|NCT04881942|183446605|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.032|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.032|<.0001
91783321|NCT04881942|183446605|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.041|||<|0.0001|TWO_SIDED|95.0|0.037|0.046|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.046|0.037|<.0001
91783322|NCT04881942|183446605|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.038|||<|0.0001|TWO_SIDED|95.0|0.033|0.042|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.042|0.033|<.0001
91783323|NCT04881942|183446606|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.536|||<|0.0001|TWO_SIDED|95.0|0.407|0.665|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.665|0.407|<.0001
91783324|NCT04881942|183446606|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.408|||<|0.0001|TWO_SIDED|95.0|0.28|0.537|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.537|0.280|<.0001
91783325|NCT04881942|183446606|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.468|||<|0.0001|TWO_SIDED|95.0|0.339|0.596|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.596|0.339|<.0001
91783326|NCT04881942|183446606|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.43|||<|0.0001|TWO_SIDED|95.0|0.301|0.559|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.559|0.301|<.0001
91594254|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.8195|TWO_SIDED|95.0|-1.61|1.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||1.28|-1.61|0.8195
91594255|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.4106|TWO_SIDED|95.0|-0.84|2.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||2.05|-0.84|0.4106
91648800|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00163|STANDARD_ERROR_OF_MEAN|0.001826||0.3729|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Rating as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.3729
91648801|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00593|STANDARD_ERROR_OF_MEAN|0.007228||0.4124|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mobility as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.4124
91648802|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00432|STANDARD_ERROR_OF_MEAN|0.009334||0.6442|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities of Daily Living as outcome variable. Linear mixed models were constructed with fixed effects terms for treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test if the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.6442
91594256|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9403|TWO_SIDED|95.0|-1.71|1.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||1.85|-1.71|0.9403
91594257|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5206|TWO_SIDED|95.0|-2.36|1.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||1.20|-2.36|0.5206
91594258|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.714|TWO_SIDED|95.0|-2.3|1.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||1.58|-2.30|0.7140
91594259|NCT00880399|183079006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.26||||0.0234|TWO_SIDED|95.0|-4.22|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.31|-4.22|0.0234
91594260|NCT02605187|183079043|SUPERIORITY|||||||0.882||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.882
91594261|NCT02605187|183079043|SUPERIORITY|||||||0.565||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.565
91594262|NCT02605187|183079043|SUPERIORITY|||||||0.022||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.022
91783327|NCT04881942|183446608|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|277.79|||<|0.0001|TWO_SIDED|95.0|213.62|341.96|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||341.96|213.62|<.0001
91783328|NCT04881942|183446608|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|241.32|||<|0.0001|TWO_SIDED|95.0|176.99|305.64|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||305.64|176.99|<.0001
91783329|NCT04881942|183446608|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|248.22|||<|0.0001|TWO_SIDED|95.0|184.01|312.43|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||312.43|184.01|<.0001
91783330|NCT04881942|183446608|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|257.92|||<|0.0001|TWO_SIDED|95.0|193.58|322.26|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||322.26|193.58|<.0001
91783331|NCT04881942|183446609|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.223|||<|0.0001|TWO_SIDED|95.0|1.915|2.58|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.580|1.915|<.0001
91783332|NCT04881942|183446609|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.203|||<|0.0001|TWO_SIDED|95.0|1.897|2.557|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.557|1.897|<.0001
91783333|NCT04881942|183446609|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.101|||<|0.0001|TWO_SIDED|95.0|1.81|2.439|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.439|1.810|<.0001
91783334|NCT04881942|183446609|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|2.052|||<|0.0001|TWO_SIDED|95.0|1.767|2.382|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.382|1.767|<.0001
91594263|NCT02605187|183079043|SUPERIORITY|||||||0.14||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.140
91783335|NCT04881942|183446610|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|709.86|||<|0.0001|TWO_SIDED|95.0|549.19|870.54|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||870.54|549.19|<.0001
91594264|NCT02605187|183079044|SUPERIORITY|||||||0.311||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 0-24 hours after delivery.||||0.311
91594265|NCT02605187|183079044|SUPERIORITY|||||||0.008||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 24-48 hours after delivery.||||0.008
91594266|NCT02605187|183079045|SUPERIORITY|||||||0.092|||||||Fisher Exact|||Comparison of presence of pruritus 0-24 hours after delivery.||||0.092
91594267|NCT02605187|183079045|SUPERIORITY|||||||0.269|||||||Fisher Exact|||Comparison of presence of pruritus 24-48 hours after delivery.||||0.269
91594268|NCT02605187|183079046|SUPERIORITY|||||||0.006|||||||ANOVA|||Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equal||||0.006
91594269|NCT02605187|183079046|SUPERIORITY|||||||0.296|||||||ANOVA|||Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equal||||0.296
91594270|NCT02605187|183079047|SUPERIORITY|||||||0.759|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.||||0.759
91594271|NCT02605187|183079047|SUPERIORITY|||||||0.761|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.||||0.761
91648803|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00898|STANDARD_ERROR_OF_MEAN|0.006436||0.1641|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Vitality as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1641
91648804|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01952|STANDARD_ERROR_OF_MEAN|0.009846||0.0487|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Neg. Affect as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0487
91783336|NCT04881942|183446610|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|568.35|||<|0.0001|TWO_SIDED|95.0|407.18|729.51|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||729.51|407.18|<.0001
91783337|NCT04881942|183446610|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|562.0|||<|0.0001|TWO_SIDED|95.0|401.34|722.67|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||722.67|401.34|<.0001
91783338|NCT04881942|183446610|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|517.23|||<|0.0001|TWO_SIDED|95.0|356.11|678.34|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||678.34|356.11|<.0001
91783339|NCT01147627|183446632|NON_INFERIORITY_OR_EQUIVALENCE|108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.|||||<|0.05||95.0|||||ANCOVA|||||||<0.05
91783340|NCT03328208|183446640|SUPERIORITY||Mean Difference (Final Values)|0.724|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91783341|NCT03328208|183446641|SUPERIORITY||Mean Difference (Final Values)|0.038|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91783342|NCT03656380|183446693|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
91783343|NCT03656380|183446694|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91783344|NCT03656380|183446695|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
91783345|NCT03656380|183446696|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91783346|NCT03656380|183446697|SUPERIORITY||||||<|0.001|||||||Chi-squared|||\<15 eos/hpf||||<0.001
91783347|NCT03656380|183446697|SUPERIORITY|||||||0.02|||||||Chi-squared|||≤6 eos/hpf||||0.02
91594272|NCT02605187|183079048|SUPERIORITY|||||||0.281|||||||Chi-squared|||||||0.281
91594273|NCT02605187|183079049|SUPERIORITY|||||||0.786|||||||ANOVA|||Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equal||||0.786
91594274|NCT02605187|183079049|SUPERIORITY|||||||0.985|||||||ANOVA|||Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equal||||0.985
91594275|NCT02605187|183079050|SUPERIORITY|||||||0.057|||||||Chi-squared|||Comparison of participants who need nausea treatment from 0-24 hours after delivery.||||0.057
91594276|NCT02605187|183079050|SUPERIORITY|||||||0.246|||||||Fisher Exact|||Comparison of participants who need nausea treatment from 24-48 hours after delivery.||||0.246
91594277|NCT02605187|183079051|SUPERIORITY|||||||0.226|||||||ANOVA|||Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equal||||0.226
91594278|NCT02605187|183079052|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
91594279|NCT02605187|183079053|SUPERIORITY|||||||0.019|||||||ANOVA|||Comparison of satisfaction with pain medication 24 hours after delivery.||||0.019
91594280|NCT02605187|183079053|SUPERIORITY|||||||0.873|||||||ANOVA|||Comparison of satisfaction with pain medication 48 hours after delivery.||||0.873
91594281|NCT01648790|183079054|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.983|||||TWO_SIDED|90.0|0.819|1.18|||||Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.18|0.819|
91783348|NCT03656380|183446697|SUPERIORITY|||||||0.27|||||||Chi-squared|||≤1 eos/hpf||||0.27
91783349|NCT03656380|183446698|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
91783350|NCT03656380|183446699|SUPERIORITY|||||||0.44|||||||ANCOVA|||||||0.44
91783351|NCT01727024|183446700|SUPERIORITY_OR_OTHER|||||||0.451|||||||Generalized Estimating Equation (GEE)|||||||0.451
91594282|NCT01648790|183079055|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.987|||||TWO_SIDED|90.0|0.918|1.06|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.06|0.918|
91709216|NCT01402986|183311364|SUPERIORITY_OR_OTHER||Rate Ratio|1.11||||0.685|TWO_SIDED|95.0|0.67|1.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.84|0.67|0.685
91783352|NCT02028208|183446714|OTHER|Concordance between 0.40 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.38|||||TWO_SIDED|95.0|0.08|0.67||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.67|0.08|
91783353|NCT02028208|183446714|OTHER|Concordance between 0.40 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.67|||||TWO_SIDED|95.0|0.35|0.99||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.99|0.35|
91783354|NCT02028208|183446714|OTHER|Concordance between 0.36 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.46|||||TWO_SIDED|95.0|0.15|0.76||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.76|0.15|
91783355|NCT02028208|183446714|OTHER|Concordance between 0.36 mg/cm2 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.57|||||TWO_SIDED|95.0|0.21|0.93||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.93|0.21|
91783356|NCT02028208|183446714|OTHER|Concordance between 0.10 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.48|||||TWO_SIDED|95.0|0.05|0.9||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.90|0.05|
91783357|NCT02028208|183446714|OTHER|Concordance between 0.10 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.39|||||TWO_SIDED|95.0|0.1|0.68||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.68|0.10|
91594283|NCT01648790|183079056|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.28|||||TWO_SIDED|90.0|0.233|0.335|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.335|0.233|
91594284|NCT01648790|183079057|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.779|||||TWO_SIDED|90.0|0.724|0.837|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.837|0.724|
91783358|NCT02028208|183446714|OTHER||Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between 0.30 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum||1.00|0.50|
91783359|NCT02028208|183446714|OTHER|Concordance between 0.30 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.39|-0.02|
91783360|NCT02028208|183446714|OTHER|Concordance between 0.60 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||1.00|0.50|
91783361|NCT02028208|183446714|OTHER||Kappa statistic|0.06|||||TWO_SIDED|95.0|-0.05|0.17||||Concordance between 0.60 mg/cm2 palladium and 1.0 palladium chloride in petrolatum||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.17|-0.05|
91783362|NCT03776812|183446783|OTHER||Hazard Ratio (HR)|0.83||||0.3293|TWO_SIDED|95.0|0.56|1.22|||Cox proportional hazards model|||||1.22|0.56|0.3293
91783363|NCT03776812|183446783|OTHER||Hazard Ratio (HR)|0.66||||0.0384|TWO_SIDED|95.0|0.44|0.98|||Cox proportional hazards model|||||0.98|0.44|0.0384
91783364|NCT02082119|183446812|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91783365|NCT00552188|183446814|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline value||||0.34
91783366|NCT00552188|183446815|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline||||0.15
91783367|NCT00243269|183446822|SUPERIORITY_OR_OTHER|||||||0.932||95.0|||||ANOVA|||The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.||||0.932
91783368|NCT00243269|183446823|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||ANOVA to compare means of the four groups was used.||||0.84
91783369|NCT00856518|183446835|SUPERIORITY_OR_OTHER|||||||0.899||||||EMST arm vs. Sham arm baseline MEP value comparison|Wilcoxon (Mann-Whitney)|||||||0.899
91783370|NCT00856518|183446835|SUPERIORITY_OR_OTHER|||||||0.946|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response||||||0.946
91783371|NCT00856518|183446835|SUPERIORITY_OR_OTHER|||||||0.00042|||||||t-test, 2 sided|EMST arm post vs. pre-MEP comparison||||||0.00042
91783372|NCT00856518|183446835|SUPERIORITY_OR_OTHER|||||||0.0019||||||Sham arm post vs. pre-MEP comparison|t-test, 2 sided|||||||0.0019
91783373|NCT00856518|183446837|SUPERIORITY_OR_OTHER||||||>|0.05||||||EMST arm vs. Sham arm baseline total score and subscale score comparison|Wilcoxon (Mann-Whitney)|||||||> 0.05
91594285|NCT01761084|183079120|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.58|1.94||||||||1.94|.58|
91783374|NCT00856518|183446837|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains||||||> 0.05
91783375|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.014|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response in Burden domain||||||0.014
91783376|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.022|||||||Plum Ordinal Regression test|EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain||||||0.022
91783377|NCT00856518|183446837|SUPERIORITY_OR_OTHER||||||>|0.05||||||Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains.|Wilcoxon Signed Ranks Test|||||||>0.05
91783378|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Burden domain||||||0.038
91783379|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Mental Health domain||||||0.031
91783380|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.027|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Burden domain||||||0.027
91783381|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Mental Health domain||||||0.016
91783382|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Pharyngeal domain||||||0.007
91783383|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Saliva domain||||||0.036
91783384|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Fear domain||||||0.004
91783385|NCT00856518|183446837|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score||||||0.016
91783386|NCT02867384|183446838|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
91594286|NCT01761084|183079121|SUPERIORITY||Risk Ratio (RR)|1.32|||||TWO_SIDED|95.0|0.99|1.74||||||||1.74|.99|
91594287|NCT01761084|183079122|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.811|TWO_SIDED|95.0|-0.84|1.07|||t-test, 2 sided|Intention-to-treat analysis|Intention-to-treat analysis|Baseline||1.07|-0.84|0.811
91594288|NCT01761084|183079122|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.765|TWO_SIDED|95.0|-0.8|1.09|||t-test, 2 sided||Per-protocol analysis|Month 12||1.09|-0.80|0.765
91594289|NCT01761084|183079123|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.796|TWO_SIDED|95.0|-0.8|0.61|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.61|-0.80|0.796
91594290|NCT01761084|183079123|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.888|TWO_SIDED|95.0|-0.75|0.65|||t-test, 2 sided||Per-protocol analysis|Month 12||0.65|-0.75|0.888
91594291|NCT01761084|183079124|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.719|TWO_SIDED|95.0|-0.54|0.78|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.78|-0.54|0.719
91594292|NCT01761084|183079124|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.745|TWO_SIDED|95.0|-0.56|0.79|||t-test, 2 sided||Per-protocol analysis|Month 12||0.79|-0.56|0.745
91594293|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.854|TWO_SIDED|95.0|-5.66|6.83|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in EQ5D - VAS||6.83|-5.66|0.854
91594294|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.585|TWO_SIDED|95.0|-4.66|8.22|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in EQ5D-VAS||8.22|-4.66|0.585
91594295|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.335|TWO_SIDED|95.0|-0.16|0.47|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in OQLQ Average Score||0.47|-0.16|0.335
91594296|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.285|TWO_SIDED|95.0|-0.15|0.5|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in OQLQ Average Score||0.50|-0.15|0.285
91594297|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.225|TWO_SIDED|95.0|-1.36|0.32|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS at rest||0.32|-1.36|0.225
91594298|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.488|TWO_SIDED|95.0|-1.16|0.56|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS at rest||0.56|-1.16|0.488
91648805|NCT03593772|183190401|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0066|STANDARD_ERROR_OF_MEAN|0.004644||0.1554|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Fear as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1554
91648806|NCT03593772|183190402|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00113|STANDARD_ERROR_OF_MEAN|0.000863||0.1924|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1924
91648807|NCT03593772|183190402|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0019|STANDARD_ERROR_OF_MEAN|0.001152||0.1002|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1002
91709217|NCT01402986|183311364|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.813|TWO_SIDED|95.0|0.66|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.70|0.66|0.813
91709218|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.335|TWO_SIDED|95.0|0.56|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.22|0.56|0.335
91709219|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.586|TWO_SIDED|95.0|0.54|1.41|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.41|0.54|0.586
91709220|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|1.36||||0.331|TWO_SIDED|95.0|0.73|2.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.52|0.73|0.331
91783387|NCT02105961|183446849|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.068|TWO_SIDED|95.0|0.65|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.068
91783388|NCT02105961|183446849|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.034|TWO_SIDED|95.0|0.65|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.034
91783389|NCT02105961|183446849|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period|||1.05|0.70|0.140
91783390|NCT02105961|183446849|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.05|0.70|0.140
91783391|NCT02105961|183446850|SUPERIORITY||Hazard Ratio(Mepolizumab 100/Placebo)|0.82||||0.14|TWO_SIDED|95.0|0.64|1.04||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.140
91783392|NCT02105961|183446850|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.82||||0.103|TWO_SIDED|95.0|0.64|1.04||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.103
91783393|NCT02105961|183446850|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.14|TWO_SIDED|95.0|0.6|0.97||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.140
91594299|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.808|TWO_SIDED|95.0|-0.68|0.88|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS during movement||0.88|-0.68|0.808
91783394|NCT02105961|183446850|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.03|TWO_SIDED|95.0|0.6|0.97||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.030
91594300|NCT01761084|183079125|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.566|TWO_SIDED|95.0|-0.57|1.04|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS during movement||1.04|-0.57|0.566
91594301|NCT01761084|183079128|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.951|TWO_SIDED|95.0|-1.412|1.501|||t-test, 2 sided|||Baseline||1.501|-1.412|.951
91594302|NCT01761084|183079128|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.039|TWO_SIDED|95.0|-2.721|-0.071|||t-test, 2 sided|||Month 12||-0.071|-2.721|0.039
91594303|NCT01761084|183079129|SUPERIORITY||Mean Difference (Final Values)|-65.9|||<|0.05|TWO_SIDED|95.0|-91.8|-40.0||Month 6 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-40.0|-91.8|<0.05
91594304|NCT01761084|183079129|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.05|TWO_SIDED|95.0|-69.8|-28.8||Month 12 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-28.8|-69.8|<0.05
91594305|NCT01761084|183079134|SUPERIORITY||Incident Rate Ratio|0.97|||||TWO_SIDED|95.0|0.58|1.63||||||Negative Binomial Regression.||1.63|.58|
91594306|NCT01761084|183079137|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.536|TWO_SIDED|95.0|-0.28|0.53|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in height||0.53|-0.28|0.536
91648808|NCT03593772|183190402|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000343|STANDARD_ERROR_OF_MEAN|0.000996||0.7311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7311
91648809|NCT03593772|183190403|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00241|STANDARD_ERROR_OF_MEAN|0.001716||0.1622|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1622
91594307|NCT01761084|183079138|SUPERIORITY||Mean Difference (Net)|-0.055||||0.9|TWO_SIDED|95.0|-0.917|0.807|||t-test, 2 sided|||Month 12 scores.||0.807|-0.917|.900
91594308|NCT01761084|183079139|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|13.9||0.712|TWO_SIDED|95.0|-33.6|23.2|||t-test, 2 sided|||Baseline||23.2|-33.6|.712
91783395|NCT02105961|183446851|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.14|TWO_SIDED|95.0|0.35|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.140
91783396|NCT02105961|183446851|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.042|TWO_SIDED|95.0|0.35|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.042
91783397|NCT02105961|183446851|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
91783398|NCT02105961|183446851|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
91594309|NCT01761084|183079139|SUPERIORITY||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|15.3||0.6|TWO_SIDED|95.0|-23.3|39.5|||t-test, 1 sided|||Month 12||39.5|-23.3|.60
91594310|NCT01761084|183079141|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.25|0.55|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in weight||0.55|-0.25|0.461
91594311|NCT00940589|183079143|SUPERIORITY_OR_OTHER||||||<|0.045|TWO_SIDED||||||ANCOVA|||||||<0.045
91594312|NCT00940589|183079144|SUPERIORITY_OR_OTHER||||||<|0.044|TWO_SIDED||||||ANCOVA|||||||<0.044
91594313|NCT01261507|183079145|SUPERIORITY_OR_OTHER||difference in areas under the LROC curve|-0.059|STANDARD_ERROR_OF_MEAN|0.037|<|0.05|TWO_SIDED|95.0|-0.086|-0.031|||mixed model:Dorfman, Berbaum, Metz|||Measure is the difference between the radiologists working without the software less the value for the radiologists working with the software. Thus a negative value would indicate that the the radiologists showed better results when using the software.||-0.031|-0.086|<0.05
91594314|NCT01278745|183079148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|Adjusted for baseline PAV||||||0.0019
91594315|NCT02953340|183079170|NON_INFERIORITY|The study used non inferiority margin of 0.62 days for the above comparison. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean difference|-0.074|||<|0.0001|TWO_SIDED|95.0|-0.292|0.129|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||0.129|-0.292|< 0.0001
91594316|NCT01376778|183079180|SUPERIORITY||Risk Ratio (RR)|1.17||||0.42|TWO_SIDED|95.0|0.8|1.72|||Chi-squared|||||1.72|0.80|0.42
91594317|NCT01376778|183079185|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.86|3.03||||||||3.03|0.86|
91594318|NCT01376778|183079186|SUPERIORITY||Risk Ratio (RR)|2.82|||||TWO_SIDED|95.0|0.29|72.42||||||||72.42|0.29|
91594319|NCT01376778|183079187|SUPERIORITY||Risk Difference (RD)|-0.41|||||TWO_SIDED|||||||||||||
91594320|NCT01376778|183079188|SUPERIORITY||Risk Ratio (RR)|1.47|||||TWO_SIDED|95.0|0.81|2.67||||||||2.67|0.81|
91594321|NCT01376778|183079189|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.65|4.01||||||||4.01|0.65|
91594322|NCT01376778|183079191|SUPERIORITY||Risk Ratio (RR)|1.88|||||TWO_SIDED|95.0|0.66|5.41||||||||5.41|0.66|
91594323|NCT01376778|183079192|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.66|0.15||||||||0.15|-0.66|
91594324|NCT01376778|183079193|SUPERIORITY||Risk Difference (RD)|-35.0|||||TWO_SIDED|95.0|-157.0|87.0||||||||87|-157|
91783399|NCT02105961|183446852|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.447|TWO_SIDED|95.0|-4.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.447
91783400|NCT02105961|183446852|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.18|TWO_SIDED|95.0|-4.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.180
91594325|NCT01376778|183079194|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.92|3.99||||||||3.99|0.92|
91783401|NCT02105961|183446852|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
91783402|NCT02105961|183446852|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
91594326|NCT01376778|183079198|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.03|31.5||||||||31.5|0.03|
91783403|NCT02105961|183446853|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.926|TWO_SIDED|95.0|-2.3|0.0||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.926
91783404|NCT02105961|183446853|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.055
91594327|NCT01376778|183079199|SUPERIORITY||Risk Ratio (RR)|0.48|||||TWO_SIDED|95.0|0.17|1.38||||||||1.38|0.17|
91594328|NCT01376778|183079202|SUPERIORITY||Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.32|1.23||||||||1.23|0.32|
91594329|NCT01376778|183079203|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.68||||||||1.68|0.42|
91594330|NCT01376778|183079204|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.17|5.23||||||||5.23|0.17|
91594331|NCT01376778|183079212|SUPERIORITY||Risk Ratio (RR)|1.3||||0.37|TWO_SIDED|95.0|0.7|2.5|||Chi-squared|||||2.5|0.7|0.37
91594332|NCT01376778|183079213|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
91594333|NCT01376778|183079214|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
91594334|NCT01923285|183079215|NON_INFERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001||||||The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|Chi-squared|||"The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.~If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025."||||<0.0001
91594335|NCT01923285|183079215|SUPERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025|||||=|0.0004|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||=0.0004
91613981|NCT00431847|183121845|SUPERIORITY_OR_OTHER||Slope|-0.0323|STANDARD_ERROR_OF_MEAN|0.00619|<|0.0001|TWO_SIDED|95.0|-0.0448|-0.02013|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02013|-0.0448|<0.0001
91594336|NCT01923285|183079216|OTHER|Comparison of the mean difference. Difference in intensities is calculated as the supine paresthesia intensity minus the upright paresthesia intensity.|Mean Difference (Net)|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Wilcoxon (Mann-Whitney)||Difference in paresthesia intensities is calculated as the supine paresthesia score minus the upright paresthesia score for each subject.|"Secondary endpoint compared the mean differences in upright and supine paresthesia scores between the Axium and Control groups at three months post INS implant. This endpoint was evaluated at a two-sided significance level of 0.05.~The primary hypothesis tested was: H0: μ0- μ1≤0 vs. H1: μ0- μ1\>0 where μ0 is the mean difference in paresthesia intensities in the Control group and μ1 is the mean difference in the Axium group."||2.8|1.0|<0.0001
91594337|NCT01923285|183079217|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||<0.0001
91594338|NCT01923285|183079217|SUPERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||=|0.0047|||||||Chi-squared|||||||=0.0047
91594339|NCT01923285|183079218|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.||||||0.0003|||||||Non-inferiority|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||0.0003
91594340|NCT00941668|183079250|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91709221|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|1.41||||0.311|TWO_SIDED|95.0|0.73|2.71|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.71|0.73|0.311
91783405|NCT02105961|183446853|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.926|TWO_SIDED|95.0|-1.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.926
91783406|NCT02105961|183446853|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.547|TWO_SIDED|95.0|-1.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.547
91783407|NCT04380519|183446861|SUPERIORITY||Risk Ratio (RR)|1.012||||0.434|ONE_SIDED|97.5|0.88|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.880|0.434
91783408|NCT04380519|183446861|SUPERIORITY||Risk Ratio (RR)|1.125||||0.073|ONE_SIDED|97.5|0.989|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.989|0.073
91783409|NCT04380519|183446863|SUPERIORITY||Risk Ratio (RR)|1.019||||0.393|ONE_SIDED|97.5|0.892|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.892|0.393
91783410|NCT04380519|183446863|SUPERIORITY||Risk Ratio (RR)|1.098||||0.061|ONE_SIDED|97.5|0.975|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.975|0.061
91783411|NCT04380519|183446864|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.31|1.44||||||||1.44|0.31|
91783412|NCT04380519|183446864|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.12|0.89||||||||0.89|0.12|
91783413|NCT04380519|183446864|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.28|1.49||||||||1.49|0.28|
91594341|NCT00941668|183079251|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91594342|NCT00916149|183079255|OTHER||||||>|0.05||||||For each group (levetiracetam and no treatment), the change in IEDs/hour from pre to post-intervention: p \>0.05. The a priori threshold for statistical significance was p=0.05.|Wilcoxon Signed Ranks Test|||Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)||||>0.05
91594343|NCT00916149|183079256|OTHER|||||||0.005|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.||||0.005
91594344|NCT00916149|183079256|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.||||>0.05
91594345|NCT00916149|183079257|OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.||||0.016
91783414|NCT04380519|183446864|SUPERIORITY||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.11|0.87||||||||0.87|0.11|
91783415|NCT04380519|183446865|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.93|5.92||||||||5.92|0.93|
91783416|NCT04380519|183446865|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.55|4.09||||||||4.09|0.55|
91783417|NCT04380519|183446865|SUPERIORITY||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.94|6.81||||||||6.81|0.94|
91783418|NCT04380519|183446865|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.53|4.46||||||||4.46|0.53|
91783419|NCT04173494|183446866|SUPERIORITY||Stratified Cochran-Mantel-Haenszel|15.67||||0.0095|TWO_SIDED|95.0|5.54|25.81|||Cochran-Mantel-Haenszel|||||25.81|5.54|0.0095
91790383|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.104||0.625|TWO_SIDED|95.0|-0.255|0.154||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.154|-0.255|0.625
91790384|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91594346|NCT00916149|183079257|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.||||>0.05
91709222|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|0.81||||0.414|TWO_SIDED|95.0|0.48|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.35|0.48|0.414
91594347|NCT00916149|183079258|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.||||>0.05
91594348|NCT00916149|183079258|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.||||>0.05
91594349|NCT00916149|183079259|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.||||>0.05
91594350|NCT00916149|183079259|OTHER|||||||0.045|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.||||0.045
91594351|NCT00916149|183079260|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.||||>0.05
91594352|NCT00916149|183079260|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.||||>0.05
91594353|NCT00916149|183079261|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment group||||>0.05
91594354|NCT00916149|183079261|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment group||||>0.05
91594355|NCT00916149|183079262|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment group||||>0.05
91594356|NCT00916149|183079262|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment group||||>0.05
91594357|NCT00916149|183079263|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment group||||>0.05
91594358|NCT00916149|183079264|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment group||||>0.05
91594359|NCT00916149|183079264|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment group||||>0.05
91594360|NCT00916149|183079265|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment group||||>0.05
91594361|NCT00916149|183079265|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment group||||>0.05
91648810|NCT03593772|183190403|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00235|STANDARD_ERROR_OF_MEAN|0.002052||0.254|TWO_SIDED||||||Mixed Models Analysis|||Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2540
91594362|NCT00916149|183079266|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment group||||>0.05
91594363|NCT00916149|183079266|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment group||||>0.05
91594364|NCT00916149|183079267|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment group||||>0.05
91594365|NCT00916149|183079267|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
91594366|NCT00916149|183079268|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the no treatment group||||>0.05
91594367|NCT00916149|183079268|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment group||||>0.05
91594368|NCT00916149|183079269|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment group||||>0.05
91594369|NCT00916149|183079269|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
91594370|NCT00916149|183079270|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment group||||>0.05
91594371|NCT00916149|183079270|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment group||||>0.05
91594372|NCT00916149|183079271|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment group||||>0.05
91594373|NCT00916149|183079271|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment group||||>0.05
91594374|NCT00916149|183079272|OTHER|||||||0.014|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment group||||0.014
91594375|NCT00916149|183079272|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment group||||>0.05
91594376|NCT00916149|183079273|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment group||||>0.05
91594377|NCT00916149|183079273|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
91594378|NCT00916149|183079274|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment group||||>0.05
91594379|NCT00916149|183079274|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment group||||>0.05
91594380|NCT00916149|183079275|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment group||||>0.05
91594381|NCT00916149|183079276|OTHER|||||||0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment group||||0.05
91594382|NCT00916149|183079277|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
91594383|NCT00916149|183079277|OTHER|||||||0.039|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||0.039
91594384|NCT00916149|183079278|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
91648811|NCT03593772|183190403|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00612|STANDARD_ERROR_OF_MEAN|0.002297||0.0082|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0082
91594385|NCT00916149|183079278|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
91594386|NCT00916149|183079279|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
91594387|NCT00916149|183079279|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
91594388|NCT00916149|183079280|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
91594389|NCT00916149|183079280|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
91594390|NCT00916149|183079281|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
91648812|NCT03593772|183190403|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00636|STANDARD_ERROR_OF_MEAN|0.002378||0.0079|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0079
91648813|NCT03593772|183190403|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00334|STANDARD_ERROR_OF_MEAN|0.002367||0.1588|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1588
91594391|NCT00916149|183079281|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
91783420|NCT04173494|183446867|NON_INFERIORITY|If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.|Non-inferiority difference|13.58||||0.0116|TWO_SIDED|95.0|1.86|25.3|||Cochran-Mantel-Haenszel||Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.|||25.30|1.86|0.0116
91783421|NCT04173494|183446868|OTHER||Stratified Cochran-Mantel-Haenszel|33.05|||<|0.0001|TWO_SIDED|95.0|22.59|43.51|||Cochran-Mantel-Haenszel|||||43.51|22.59|< 0.0001
91783422|NCT04173494|183446869|OTHER||Least Squares Mean Difference|-6.22||||0.0014|TWO_SIDED|95.0|-10.0|-2.43|||mixed model for repeated measures (MMRM)|||||-2.43|-10.0|0.0014
91783423|NCT04173494|183446870|OTHER||Stratified Cochran-Mantel-Haenszel|18.18||||0.0011|TWO_SIDED|95.0|9.77|26.59|||Cochran-Mantel-Haenszel|||||26.59|9.77|0.0011
91783424|NCT04173494|183446871|OTHER||Stratified Cochran-Mantel-Haenszel|17.2||||0.0012|TWO_SIDED|95.0|7.99|26.4|||Cochran-Mantel-Haenszel|||||26.40|7.99|0.0012
91783425|NCT04173494|183446872|OTHER||Stratified Cochran-Mantel-Haenszel|10.62||||0.1133|TWO_SIDED|95.0|-2.4|23.64|||Cochran-Mantel-Haenszel|||||23.64|-2.40|0.1133
91783426|NCT04173494|183446875|OTHER||Hazard Ratio (HR)|0.556||||0.0006|TWO_SIDED|95.0|0.397|0.778|||Anderson & Gill proportional means model|||||0.778|0.397|0.0006
91783427|NCT04173494|183446876|OTHER||Stratified CMH|-8.26||||0.1602|TWO_SIDED|95.0|-20.18|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.18|0.1602
91783428|NCT04173494|183446877|OTHER||Stratified CMH|19.0||||0.0124|TWO_SIDED|95.0|4.68|33.32|||Cochran-Mantel-Haenszel||\>=1g/dL Increase in Hemoglobin response|||33.32|4.68|0.0124
91783429|NCT04173494|183446877|OTHER||Stratified CMH|15.68||||0.0282|TWO_SIDED|95.0|2.47|28.9|||Cochran-Mantel-Haenszel||\>=1.5g/dL Increase in Hemoglobin response|||28.90|2.47|0.0282
91783430|NCT04173494|183446877|OTHER||Stratified CMH|6.97||||0.2844|TWO_SIDED|95.0|-5.41|19.35|||Cochran-Mantel-Haenszel||\>=2g/dL Increase in Hemoglobin response|||19.35|-5.41|0.2844
91783431|NCT04173494|183446882|OTHER||Hazard Ratio (HR)|0.89||||0.6879|TWO_SIDED|95.0|0.504|1.572|||Log Rank|||||1.572|0.504|0.6879
91783432|NCT04173494|183446883|OTHER||Hazard Ratio (HR)|0.804||||0.432|TWO_SIDED|95.0|0.466|1.386|||Log Rank|||||1.386|0.466|0.4320
91783433|NCT04173494|183446884|OTHER||Least Squares Mean Difference|-0.71||||0.0513|TWO_SIDED|95.0|-1.42|0.0|||MMRM|||||0.00|-1.42|0.0513
91783434|NCT04173494|183446885|OTHER||Least Squares Mean Difference|-10.82||||0.0113|TWO_SIDED|95.0|-19.15|-2.48|||MMRM|||||-2.48|-19.15|0.0113
91783435|NCT04173494|183446886|OTHER||Least Squares Mean Difference|1.31||||0.357|TWO_SIDED|95.0|-1.49|4.11|||MMRM|||||4.11|-1.49|0.3570
91783436|NCT05300763|183446909|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|1.25|3.22|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.22|1.25|
91783437|NCT05300763|183446910|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (96.25%) confidence interval is above 1.|Odds Ratio (OR)|2.0|||||TWO_SIDED|96.25|1.18|3.41|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.41|1.18|
91783438|NCT05300763|183446911|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (97.5 %) confidence interval is above 1.|Odds Ratio (OR)|2.17|||||TWO_SIDED|97.5|1.3|3.64|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.64|1.30|
91783439|NCT05300763|183446912|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.04|3.02|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.02|1.04|
91783440|NCT01485172|183446913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.864|TWO_SIDED|95.0|-3.41|4.05||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.05|-3.41|0.864
91783441|NCT01485172|183446913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.539|TWO_SIDED|95.0|-3.61|1.9||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.90|-3.61|0.539
91783442|NCT01485172|183446913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.091|TWO_SIDED|95.0|-5.21|0.39||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.39|-5.21|0.091
91783443|NCT01485172|183446913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.124|TWO_SIDED|95.0|-4.93|0.6||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.60|-4.93|0.124
91783444|NCT01485172|183446913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.658|TWO_SIDED|95.0|-5.04|3.19||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||3.19|-5.04|0.658
91783445|NCT01485172|183446913|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.439
91783446|NCT01485172|183446913|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.177
91783447|NCT01485172|183446913|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.060
91783448|NCT01485172|183446913|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.047
91783449|NCT01485172|183446913|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.407
91783450|NCT01485172|183446914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.003||||0.397|TWO_SIDED|95.0|0.4|9.98|||Generalized Estimating Equations model|||||9.98|0.40|0.397
91783451|NCT01485172|183446914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.242||||0.131|TWO_SIDED|95.0|0.79|6.4|||Generalized Estimating Equations model|||||6.40|0.79|0.131
91783452|NCT01485172|183446914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.515||||0.018|TWO_SIDED|95.0|1.25|9.92|||Generalized Estimating Equations model|||||9.92|1.25|0.018
91783453|NCT01485172|183446914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.02||95.0|1.22|10.64|||Generalized Estimating Equations model|||||10.64|1.22|0.020
91783454|NCT01485172|183446914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.679||||0.202|TWO_SIDED|95.0|0.59|12.16|||Generalized Estimating Equations model|||||12.16|0.59|0.202
91783455|NCT01485172|183446915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.544||||0.662||95.0|0.22|10.84|||Generalized Estimating Equations model|||||10.84|0.22|0.662
91594392|NCT00916149|183079282|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
91594393|NCT00916149|183079282|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
91783456|NCT01485172|183446915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.485||||0.557|TWO_SIDED|95.0|0.4|5.55|||Generalized Estimating Equations model|||||5.55|0.40|0.557
91594394|NCT00916149|183079283|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
91594395|NCT00916149|183079283|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
91594396|NCT00916149|183079284|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
91594397|NCT00916149|183079284|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
91594398|NCT00916149|183079285|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment group||||>0.05
91594399|NCT00916149|183079285|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment group||||>0.05
91594400|NCT00916149|183079286|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the no treatment group||||>0.05
91594401|NCT00916149|183079286|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment group||||>0.05
91594402|NCT00978029|183079287|SUPERIORITY_OR_OTHER||Percent Difference|6.9||||0.486|TWO_SIDED|95.0|-10.17|23.97|||Fisher Exact|||||23.97|-10.17|0.486
91594403|NCT00978029|183079287|SUPERIORITY_OR_OTHER||Percent Difference|16.9||||0.078|TWO_SIDED|95.0|0.01|33.83|||Fisher Exact|||||33.83|0.01|0.078
91594404|NCT02662036|183079295|SUPERIORITY|||||||0.76|||||||Mann Whitney U Test|||Statistical analysis #1 is for intraoperative opioid use||||0.76
91594405|NCT02662036|183079295|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||Statistical analysis #2 is for postoperative acute care unit opioid use||||0.38
91594406|NCT02662036|183079295|SUPERIORITY|||||||0.69|||||||Mann Whitney U Test|||Statistical analysis #3 is for postoperative floor opioid use||||0.69
91783457|NCT01485172|183446915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.347|TWO_SIDED|95.0|0.51|6.72|||Generalized Estimating Equations model|||||6.72|0.51|0.347
91783458|NCT01485172|183446915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.379|TWO_SIDED|95.0|0.49|6.38|||Generalized Estimating Equations model|||||6.38|0.49|0.379
91783459|NCT01485172|183446915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.194||||0.851|TWO_SIDED|95.0|0.19|7.63|||Generalized Estimating Equations model|||||7.63|0.19|0.851
91783460|NCT01485172|183446917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.54|TWO_SIDED|95.0|0.36|7.03|||Generalized Estimating Equations model|||||7.03|0.36|0.540
91783461|NCT01485172|183446917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.473||||0.494|TWO_SIDED|95.0|0.49|4.47|||Generalized Estimating Equations model|||||4.47|0.49|0.494
91783462|NCT01485172|183446917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.391||||0.115|TWO_SIDED|95.0|0.81|7.06|||Generalized Estimating Equations model|||||7.06|0.81|0.115
91783463|NCT01485172|183446917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96||||0.045|TWO_SIDED|95.0|1.02|8.55|||Generalized Estimating Equations model|||||8.55|1.02|0.045
91783464|NCT01485172|183446917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506||||0.221|TWO_SIDED|95.0|0.58|10.9|||Generalized Estimating Equations model|||||10.90|0.58|0.221
91783465|NCT01485172|183446918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.662|TWO_SIDED|95.0|-3.78|5.93||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.93|-3.78|0.662
91783466|NCT01485172|183446918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.621|TWO_SIDED|95.0|-4.63|2.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.77|-4.63|0.621
91783467|NCT01485172|183446918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.75||||0.15|TWO_SIDED|95.0|-6.5|1.01||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.01|-6.50|0.150
91783468|NCT01485172|183446918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74||||0.048|TWO_SIDED|95.0|-7.43|-0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.04|-7.43|0.048
91783469|NCT01485172|183446918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.715|TWO_SIDED|95.0|-6.32|4.35||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.35|-6.32|0.715
91783470|NCT01485172|183446919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.158|TWO_SIDED|95.0|-0.46|2.81||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.81|-0.46|0.158
91783471|NCT01485172|183446919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.446|TWO_SIDED|95.0|-1.71|0.76||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.76|-1.71|0.446
91783472|NCT01485172|183446919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.163|TWO_SIDED|95.0|-2.1|0.36||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.36|-2.10|0.163
91594407|NCT02662036|183079295|SUPERIORITY|||||||0.98|||||||Mann Whitney U Test|||Statistical analysis #4 is for total opioid use||||0.98
91594408|NCT02662036|183079296|SUPERIORITY|||||||0.28|||||||Mann Whitney U Test|||Statistical analysis #1 is for postoperative acute care unit antiemetic use||||0.28
91594409|NCT02662036|183079296|SUPERIORITY|||||||0.62|||||||Mann Whitney U Test|||Statistical analysis #2 is for floor antiemetic use||||0.62
91594410|NCT02662036|183079296|SUPERIORITY|||||||0.5|||||||Mann Whitney U Test|||Statistical analysis #3 is for total antiemetic use||||0.50
91594411|NCT02662036|183079297|SUPERIORITY|||||||0.2|||||||Mann Whitney U Test|||||||0.20
91594412|NCT02662036|183079298|SUPERIORITY|||||||0.64|||||||Mann Whitney U Test|||||||0.64
91783473|NCT01485172|183446919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.117|TWO_SIDED|95.0|-2.27|0.25||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.25|-2.27|0.117
91783474|NCT01485172|183446919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.456|TWO_SIDED|95.0|-2.67|1.2||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.20|-2.67|0.456
91783475|NCT01485172|183446920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.823|TWO_SIDED|95.0|-4.38|5.5||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.50|-4.38|0.823
91783476|NCT01485172|183446920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.568|TWO_SIDED|95.0|-4.86|2.68||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.68|-4.86|0.568
91783477|NCT01485172|183446920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0.101|TWO_SIDED|95.0|-7.01|0.63||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.63|-7.01|0.101
91783478|NCT01485172|183446920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94||||0.04|TWO_SIDED|95.0|-7.7|-0.18||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.18|-7.70|0.040
91783479|NCT01485172|183446920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.811|TWO_SIDED|95.0|-6.08|4.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.77|-6.08|0.811
91783480|NCT01485172|183446921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.102|TWO_SIDED|95.0|-0.86|0.08||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.08|-0.86|0.102
91783481|NCT01485172|183446921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.723|TWO_SIDED|95.0|-0.41|0.29||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.29|-0.41|0.723
91783482|NCT01485172|183446921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.084|TWO_SIDED|95.0|-0.66|0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.04|-0.66|0.084
91783483|NCT01485172|183446921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.697|TWO_SIDED|95.0|-0.42|0.28||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.28|-0.42|0.697
91783484|NCT01485172|183446921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.086|TWO_SIDED|95.0|-0.06|0.97||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.97|-0.06|0.086
91783485|NCT01485172|183446922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.769||||0.733|TWO_SIDED|95.0|0.17|3.49|||Generalized Estimating Equations model|||||3.49|0.17|0.733
91783486|NCT01485172|183446922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.411||||0.519|TWO_SIDED|95.0|0.5|4.02|||Generalized Estimating Equations model|||||4.02|0.50|0.519
91783487|NCT01485172|183446922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.204||||0.008|TWO_SIDED|95.0|1.46|12.07|||Generalized Estimating Equations model|||||12.07|1.46|0.008
91783488|NCT01485172|183446922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.001|TWO_SIDED|95.0|1.93|15.46|||Generalized Estimating Equations model|||||15.46|1.93|0.001
91783489|NCT01485172|183446922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.281||||0.752|TWO_SIDED|95.0|0.27|5.98|||Generalized Estimating Equations model|||||5.98|0.27|0.752
91783490|NCT03051178|183446930|SUPERIORITY||||||<|0.01||||||All post-hoc comparisons were Bonferroni corrected.|ANOVA|||TRS scores measured across different stimulation conditions were assessed using a mixed model ANOVA with the participant as a random effect. All post-hoc comparisons were Bonferroni corrected.||||<0.01
91783491|NCT00048074|183446941|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (2mg q 2 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.257|||<|0.001|TWO_SIDED|95.0|0.701|1.814|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.814|0.701|<0.001
91783492|NCT00048074|183446941|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (3mg q 3 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.025|||<|0.001|TWO_SIDED|95.0|0.471|1.578|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.578|0.471|<0.001
91783493|NCT02395081|183446960|SUPERIORITY|||||||0.7||||||SBP wk 16-20|ANOVA|||||||0.70
91783494|NCT02395081|183446962|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
91783495|NCT02395081|183446963|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
91783496|NCT02395081|183446965|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
91783497|NCT02395081|183446966|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91783498|NCT02395081|183446967|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
91783499|NCT02395081|183446968|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91783500|NCT02395081|183446969|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
91783501|NCT02395081|183446970|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91783502|NCT00356304|183446981|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<.05
91783503|NCT02504216|183446985|SUPERIORITY||Hazard Ratio (HR)|0.85|||=|0.0043|TWO_SIDED|95.0|0.76|0.96|||Log Rank|P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||IxRS: Interactive web/voice response system||0.96|0.76|=0.0043
91594413|NCT02662036|183079299|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||||||0.38
91594414|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-6.4|11.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||11.2|-6.4|
91594415|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||8.3|-10.8|
91594416|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-9.3|13.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||13.2|-9.3|
91648814|NCT03593772|183190404|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00974|STANDARD_ERROR_OF_MEAN|0.01379||0.4808|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PCL-5 Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4808
91709223|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.463|TWO_SIDED|95.0|0.68|2.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||2.36|0.68|0.463
91709224|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.793|TWO_SIDED|95.0|0.67|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.68|0.67|0.793
91783504|NCT02504216|183446986|OTHER||Hazard Ratio (HR)|1.43|||=|0.0695|TWO_SIDED|95.0|0.97|2.1|||Log Rank|P-value (2-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||||2.10|0.97|=0.0695
91783505|NCT02504216|183446987|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0004|TWO_SIDED|95.0|0.71|0.91||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.91|0.71|=0.0004
91783506|NCT02504216|183446988|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.014|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0140
91783507|NCT02504216|183446989|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.62|0.85||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.85|0.62|<0.0001
91783508|NCT02504216|183446990|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.0145|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0145
91783509|NCT02504216|183446991|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0051|TWO_SIDED|95.0|0.76|0.96||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.96|0.76|=0.0051
91783510|NCT02504216|183446992|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.8322|TWO_SIDED|95.0|0.92|1.27||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.27|0.92|=0.8322
91783511|NCT02504216|183446993|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0235|TWO_SIDED|95.0|0.37|1.0||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.00|0.37|=0.0235
91783512|NCT02504216|183446994|OTHER||Hazard Ratio (HR)|1.42|||=|0.0068|TWO_SIDED|95.0|1.1|1.84|||Log Rank|||||1.84|1.10|=0.0068
91783513|NCT02504216|183446995|OTHER||Hazard Ratio (HR)|1.29|||=|0.0979|TWO_SIDED|95.0|0.95|1.76|||Log Rank|||||1.76|0.95|=0.0979
91783514|NCT03237286|183447023|SUPERIORITY|||||||0.0004|||||||Regression, Linear|||||||.0004
91783515|NCT00104520|183447063|SUPERIORITY_OR_OTHER|||||||0.007||0.0||||Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.|Log Rank|||H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, \~210 subjects (70 in each AZLI group, 35 in each placebo group) provided \>90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.||||0.0070
91783516|NCT00104520|183447064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.01||||0.0196|TWO_SIDED|95.0|0.81|9.21||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.||9.21|0.81|0.0196
91783517|NCT00104520|183447065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.28||||0.0012|TWO_SIDED|95.0|2.5|10.06||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).||10.060|2.500|0.0012
91783518|NCT00104520|183447067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659||||0.0059|TWO_SIDED|95.0|-1.125|-0.193|||ANCOVA|ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\<=2, 4-8, 16-128 or \>=256 μg/mL) value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.||-0.193|-1.125|0.0059
91783519|NCT03523988|183447085|SUPERIORITY|||||||0.04||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.04
91783520|NCT03523988|183447085|SUPERIORITY|||||||0.63||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.63
91594417|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-11.4|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||11.4|-11.4|
91522014|NCT00409682|182918999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.51||||0.038|TWO_SIDED|95.0|-0.01|27.04||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||27.04|-0.01|0.038
91594418|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-14.8|||||TWO_SIDED|95.0|-29.2|-0.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||-0.3|-29.2|
91594419|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-20.9|6.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||6.9|-20.9|
91594420|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-17.6|||||TWO_SIDED|95.0|-32.8|-2.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-2.4|-32.8|
91594421|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-34.1|-3.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-3.9|-34.1|
91594422|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
91594423|NCT02090413|183079311|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
91783521|NCT03523988|183447085|SUPERIORITY|||||||0.41||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.41
91783522|NCT03523988|183447086|SUPERIORITY|||||||0.65||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.65
91594424|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-2.6|12.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.4|-2.6|
91594425|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.5|12.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.5|-2.5|
91594426|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.1|-11.2|
91594427|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.3|-10.8|
91594428|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-1.8|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.8|
91594429|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-1.7|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.7|
91594430|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-5.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||17.3|-5.4|
91594431|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-6.4|16.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||16.4|-6.4|
91783523|NCT03523988|183447086|SUPERIORITY|||||||0.82||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.82
91783524|NCT03523988|183447086|SUPERIORITY|||||||0.69||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.69
91783525|NCT03523988|183447087|SUPERIORITY|||||||0.53||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.53
91783526|NCT03523988|183447087|SUPERIORITY|||||||0.31||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.31
91594432|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-19.5|3.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||3.5|-19.5|
91594433|NCT02090413|183079312|SUPERIORITY_OR_OTHER||Difference in percentage|-11.3|||||TWO_SIDED|95.0|-23.1|0.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||0.6|-23.1|
91594434|NCT02090413|183079315|SUPERIORITY_OR_OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-15.8|13.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||13.0|-15.8|
91594435|NCT02090413|183079315|SUPERIORITY_OR_OTHER||Difference in percentage|5.4|||||TWO_SIDED|95.0|-8.4|19.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||19.1|-8.4|
91594436|NCT02090413|183079315|SUPERIORITY_OR_OTHER||Difference in percentage|6.5|||||TWO_SIDED|95.0|-9.9|23.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||23.0|-9.9|
91594437|NCT02090413|183079315|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||||TWO_SIDED|95.0|0.2|31.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||31.3|0.2|
91783527|NCT03523988|183447087|SUPERIORITY|||||||0.37||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.37
91783528|NCT00806819|183447155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0435|TWO_SIDED|95.0|0.7|0.99|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||0.99|0.70|0.0435
91783529|NCT00806819|183447156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.894|TWO_SIDED|95.0|0.85|1.21|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.21|0.85|0.8940
91783530|NCT00806819|183447157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0506|TWO_SIDED|95.0|0.7|1.0|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.00|0.70|0.0506
91783531|NCT00806819|183447158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0865|TWO_SIDED|95.0|0.73|1.02|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.02|0.73|0.0865
91783532|NCT00806819|183447159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7279|TWO_SIDED|95.0|0.65|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|0.65|0.7279
91783533|NCT00806819|183447159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.518|TWO_SIDED|95.0|0.75|1.76||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||1.76|0.75|0.5180
91783534|NCT00806819|183447162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0387|TWO_SIDED|95.0|1.02|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|1.02|0.0387
91783535|NCT00806819|183447162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.1071|TWO_SIDED|95.0|0.95|1.75||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||1.75|0.95|0.1071
91783536|NCT00806819|183447164|SUPERIORITY_OR_OTHER|||||||0.1558|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||0.1558
91783537|NCT00806819|183447164|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||0.0565
91783538|NCT00806819|183447165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5068|TWO_SIDED|95.0|0.74|1.16|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.16|0.74|0.5068
91783539|NCT00806819|183447166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1181|TWO_SIDED|95.0|0.66|1.05|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.05|0.66|0.1181
91783540|NCT00806819|183447166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4264|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.12|0.77|0.4264
91783541|NCT00806819|183447166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8929|TWO_SIDED|95.0|0.84|1.23|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.23|0.84|0.8929
91783542|NCT00912197|183447202|SUPERIORITY|||||||0.135|||||||ANCOVA|||||||0.135
91783543|NCT00912197|183447203|SUPERIORITY|||||||0.688|||||||ANCOVA|||||||0.688
91594438|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||15.4|-10.2|
91594439|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.6|16.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||16.6|-8.6|
91594440|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||18.9|-12.8|
91783544|NCT00912197|183447204|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||after treatment, 56 days||||0.715
91783545|NCT00912197|183447205|SUPERIORITY|||||||0.578|||||||ANCOVA|||||||0.578
91783546|NCT00912197|183447205|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||baseline to after treatment, at 56 days||||0.007
91783547|NCT00912197|183447205|SUPERIORITY|||||||0.05||||||calculated|t-test, 2 sided|||baseline to after treatment, at 56 days||||0.05
91783548|NCT00912197|183447209|SUPERIORITY|||||||0.024|||||||ANCOVA|||Acetate||||0.024
91783549|NCT00756613|183447214|EQUIVALENCE|We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.|Cox Proportional Hazard|0.91||||0.24|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.||1.06|0.78|0.24
91783550|NCT00756613|183447215|EQUIVALENCE|The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.|Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.88|1.18|||Regression, Cox|||||1.18|0.88|0.81
91783551|NCT00756613|183447216|EQUIVALENCE|The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.|Cox Proportional Hazard|0.9||||0.48|TWO_SIDED|95.0|0.67|1.2|||Regression, Cox|||||1.20|0.67|0.48
91783552|NCT00756613|183447218|EQUIVALENCE|T-test comparing between the two groups of treatment using the average score of last two surveys.|Mean Difference (Final Values)|1.61||||0.172|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.172
91594441|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|12.3|||||TWO_SIDED|95.0|-2.8|27.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||27.3|-2.8|
91594442|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-15.7|12.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||12.2|-15.7|
91594443|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-9.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||17.3|-9.4|
91783553|NCT03801044|183447227|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91594444|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-25.1|7.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||7.0|-25.1|
91783554|NCT04901715|183447243|OTHER|||||||0.002|||||||ANOVA|||||||0.002
91783555|NCT04901715|183447243|OTHER|||||||0.054|||||||ANOVA|||||||0.054
91783556|NCT04901715|183447243|OTHER|||||||0.27|||||||ANOVA|||||||0.27
91783557|NCT04901715|183447244|OTHER|||||||0.014|||||||ANOVA|||||||0.014
91783558|NCT04901715|183447244|OTHER|||||||0.066|||||||ANOVA|||||||0.066
91783559|NCT04901715|183447244|OTHER|||||||0.58|||||||ANOVA|||||||0.58
91783560|NCT00147069|183447287|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
91783561|NCT00147069|183447288|SUPERIORITY|||||||0.05||||||The reported p value was calculated|Kruskal-Wallis|||||||0.05
91783562|NCT00147069|183447289|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
91783563|NCT00147069|183447290|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
91783564|NCT00122980|183447297|NON_INFERIORITY_OR_EQUIVALENCE|"Based on pilot data, the efficacy of hydroxyurea to reduce secondary stroke rate was not predicted to be equivalent to transfusions. Therefore, an increased stroke rate (non-inferiority margin = 0.20) was allowed by study design. This acceptable stroke margin was predicted to be offset by the likelihood of significantly greater improvement in the management of iron overload through elimination of transfusions along with serial phlebotomy in the Hydroxyurea/Phlebotomy arm."||||||0.214||95.0|||||Log Rank|||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20, the non-inferiority margin, AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean LIC is less than for Transfusion/Chelation (see next primary endpoint analysis).||||0.214
91783565|NCT00122980|183447298|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||The a priori defined LOCF approach was deemed to be biased due to the study's early termination, and was replaced by this mixed models analysis.|Mixed Models Analysis|Including main effects of age at consent, baseline iron, and treatment group, on observed change from baseline Log10 transformed values only.||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis (see previous primary endpoint analysis) in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20 AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean log10 transformed LIC is less than for Transfusion/Chelation.||||0.144
91594445|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|3.3|||||TWO_SIDED|95.0|-12.0|18.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||18.5|-12.0|
91594446|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-13.5|12.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||12.9|-13.5|
91594447|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||15.4|-10.2|
91594448|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|||||TWO_SIDED|95.0|-15.3|15.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||15.7|-15.3|
91594449|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|4.8|||||TWO_SIDED|95.0|-10.3|19.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||19.9|-10.3|
91594450|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-18.4|14.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||14.3|-18.4|
91594451|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|13.7|||||TWO_SIDED|95.0|-1.9|29.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||29.3|-1.9|
91594452|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-22.1|11.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||11.8|-22.1|
91783566|NCT00122980|183447299|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
91783567|NCT00122980|183447300|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||>0.05
91783568|NCT00122980|183447301|SUPERIORITY_OR_OTHER|||||||0.841||95.0|||||ANOVA|||The change-from-baseline to endpoint scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||0.841
91783569|NCT00122980|183447302|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
91783570|NCT00122980|183447303|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||0.039
91783571|NCT00122980|183447304|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|Analysis controlling for baseline value and time on study.||||||0.033
91783572|NCT00122980|183447305|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Controlling for baseline value and time on study||||||<0.01
91783573|NCT00459732|183447306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|95.0|||||ANOVA|||||||0.13
91594453|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|7.1|||||TWO_SIDED|95.0|-9.6|23.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||23.9|-9.6|
91783574|NCT00459732|183447307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|TWO_SIDED|95.0|||||ANOVA|Repeated measures||||||0.44
91783575|NCT00459732|183447308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|95.0|||||ANCOVA|Repeated measures analysis of variance adjusted for baseline osteocalcin level.||||||0.16
91783576|NCT00724711|183447318|NON_INFERIORITY_OR_EQUIVALENCE|"This study was designed to show noninferiority (change of \< 12%) in regard of proportions of responders (TLOVR) at Week 48.~With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than -0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.~312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%."|Difference in percentages between groups|3.0|||||TWO_SIDED|95.0|-5.1|11.2|||Inverted two one-sided tests|Inverted two one-sided tests with the standardized statistic||"Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)"||11.2|-5.1|
91783577|NCT00535288|183447374|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.2|||<|0.01|TWO_SIDED|95.0|-2.2|-0.2||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.2|-2.2|<0.01
91783578|NCT00535288|183447374|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.7|||<|0.01|TWO_SIDED|95.0|-2.7|-0.7||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.7|-2.7|<0.01
91522015|NCT00409682|182919000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|2.903||0.161|TWO_SIDED|95.0|-9.86|1.66||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|"Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.~The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience)."||1.66|-9.86|0.161
91522016|NCT00409682|182919001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.941||0.735|TWO_SIDED|95.0|-6.88|4.88|||ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.||4.88|-6.88|0.735
91594454|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8 combined||25.5|-6.8|
91522017|NCT04710927|182919007|OTHER||Odds Ratio (OR)|0.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91522018|NCT04710927|182919007|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91594455|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8||25.5|-6.8|
91594456|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-13.2|20.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||20.8|-13.2|
91594457|NCT02090413|183079316|SUPERIORITY_OR_OTHER||Difference in percentage|8.4|||||TWO_SIDED|95.0|-8.5|25.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||25.3|-8.5|
91594458|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.414|0.125|||||Analysis of variance model (ANCOVA) model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.125|-0.414|
91594459|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.392|||||TWO_SIDED|95.0|-0.656|-0.128|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||-0.128|-0.656|
91594460|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-0.507|0.012|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.012|-0.507|
91594461|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.376|||||TWO_SIDED|95.0|-0.193|0.945|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.945|-0.193|
91648815|NCT03593772|183190405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00033|STANDARD_ERROR_OF_MEAN|0.00856||0.9692|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Physical Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9692
91783579|NCT00535288|183447374|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.4|||<|0.01|TWO_SIDED|95.0|-2.4|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.4|<0.01
91783580|NCT00535288|183447374|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-2.9|<0.01
91783581|NCT00535288|183447375|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.12|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.12|<0.01
91783582|NCT00535288|183447375|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.02|TWO_SIDED|95.0|-0.11|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.11|0.02
91783583|NCT00535288|183447375|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.13|-0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.02|-0.13|<0.01
91783584|NCT00535288|183447375|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.08|||<|0.01|TWO_SIDED|95.0|-0.14|-0.03||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.03|-0.14|<0.01
91783585|NCT00535288|183447376|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.0||||0.08|TWO_SIDED|95.0|-2.1|0.1||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||0.1|-2.1|0.08
91594462|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|||||TWO_SIDED|95.0|-0.498|0.635|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.635|-0.498|
91594463|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.308|||||TWO_SIDED|95.0|-0.867|0.251|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.251|-0.867|
91594464|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.308|0.355|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.355|-0.308|
91594465|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.374|0.254|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.254|-0.374|
91594466|NCT02090413|183079320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||||TWO_SIDED|95.0|-0.4|0.232|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.232|-0.4|
91594467|NCT05248295|183079334|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of the variables. Below, the results are reported for the effect of production condition (Unison vs. Solo) for the group of interest, People with aphasia.|Odds Ratio (OR)|1.21|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|||||Results are reported for production condition for people with aphasia (experimental group).|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|People with aphasia (PWA) were not directly compared to controls since the finding of a lower % syllables correct in any condition in PWA would be trivial. Instead, within-groups analyses were conducted to understand how the experimental variables affected syllable accuracy within each group.||||0.077
91783586|NCT00535288|183447376|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.6|||<|0.01|TWO_SIDED|95.0|-2.7|-0.5||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.5|-2.7|<0.01
91648816|NCT03593772|183190405|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01738|STANDARD_ERROR_OF_MEAN|0.007848||0.0277|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0277
91594468|NCT05248295|183079334|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the group of interest, People with aphasia.|||||>|0.1||||||Results are reported for Timing Condition for the People with aphasia.|Regression, Logistic|||||||>.1
91594469|NCT05248295|183079334|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the group of interest, People with aphasia.|Odds Ratio (OR)|1.55|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed as ((Unison Metrical)/(Unison Conversational)) / ((Solo Metrical)/(Solo Conversational))|||||<0.001
91594470|NCT05248295|183079334|OTHER||Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.14||0.036|TWO_SIDED|||||Results are reported for Production Condition for the Control group.|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|Separate regression models were used within each group. Here, the results are reported for the Control group.||||0.036
91594471|NCT05248295|183079334|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the control group.|Odds Ratio (OR)|3.36|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed with Metrical as the numerator and Conversational as the denominator|||||<0.001
91594472|NCT05248295|183079334|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the control group.|||||>|0.1|||||||Regression, Logistic|||||||>.1
91594473|NCT05248295|183079335|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of Timing Condition. Production Condition is not included in the analysis since all timing data are from the unison production condition, by definition.|Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||Results are reported for people with aphasia (experimental group).|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group rather than a true comparator. Instead, within-groups analyses were conducted to understand how the experimental variable affected timing alignment in each group.||||<0.001
91594474|NCT05248295|183079335|OTHER||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|||||Results are reported for the Control group.|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group and not a true comparator. Instead, within-groups analyses were conducted to understand how experimental variables affected timing alignment in each group.||||<0.001
91594475|NCT04490018|183079336|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|4.98|||||TWO_SIDED|95.0|0.06|10.36||||||Serogroup A||10.36|0.06|
91594476|NCT04490018|183079336|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|4.97|||||TWO_SIDED|95.0|1.58|9.5||||||Serogroup C||9.50|1.58|
91594477|NCT04490018|183079336|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.28|4.42||||||Serogroup W||4.42|-1.28|
91783587|NCT00535288|183447376|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.5|||<|0.01|TWO_SIDED|95.0|-2.7|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.7|<0.01
91594478|NCT04490018|183079336|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.88|4.77||||||Serogroup Y||4.77|-1.88|
91594479|NCT02321930|183079364|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
91594480|NCT02321930|183079365|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
91594481|NCT02321930|183079366|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
91594482|NCT02321930|183079367|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
91594483|NCT02321930|183079368|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
91594484|NCT01484977|183079371|SUPERIORITY_OR_OTHER||Retention Rate|73.3|||||TWO_SIDED|95.0|65.42|81.25||||||"Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.~The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.~This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation."||81.25|65.42|
91783588|NCT00535288|183447376|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|||<|0.01|TWO_SIDED|95.0|-3.1|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-3.1|<0.01
91613982|NCT00431847|183121845|SUPERIORITY_OR_OTHER||Chi Squared|2.65||||0.4492|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4492
91594485|NCT01133379|183079372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|4.75||0.811|TWO_SIDED|95.0|-10.5|8.24||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|-10.5|0.811
91783589|NCT00535288|183447379|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.07|TWO_SIDED|95.0|-0.12|0.0||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.00|-0.12|0.07
91594486|NCT01133379|183079372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|STANDARD_ERROR_OF_MEAN|4.75||0.105|TWO_SIDED|95.0|-17.1|1.63||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.63|-17.1|0.105
91594487|NCT01133379|183079373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.969||0.779|TWO_SIDED|95.0|-6.72|8.95||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.95|-6.72|0.779
91594488|NCT01133379|183079373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|3.969||0.217|TWO_SIDED|95.0|-12.8|2.92||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.92|-12.8|0.217
91594489|NCT01133379|183079374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|2.613||0.904|TWO_SIDED|95.0|-4.84|5.47||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.47|-4.84|0.904
91594490|NCT01133379|183079374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.613||0.129|TWO_SIDED|95.0|-9.15|1.17||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.17|-9.15|0.129
91594491|NCT01133379|183079375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|1.336||0.477|TWO_SIDED|95.0|-3.59|1.69||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.69|-3.59|0.477
91594492|NCT01133379|183079375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|1.336||0.472|TWO_SIDED|95.0|-3.6|1.67||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-3.60|0.472
91594493|NCT01133379|183079376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.726||0.86|TWO_SIDED|95.0|-5.86|4.9||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.90|-5.86|0.860
91648817|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00188|STANDARD_ERROR_OF_MEAN|0.003253||0.5642|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total PSQI Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5642
91709225|NCT01402986|183311365|SUPERIORITY_OR_OTHER||Rate Ratio|0.77||||0.264|TWO_SIDED|95.0|0.49|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.22|0.49|0.264
91783590|NCT00535288|183447379|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.05||||0.24|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.24
91594494|NCT01133379|183079376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|2.723||0.763|TWO_SIDED|95.0|-6.2|4.55||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.55|-6.20|0.763
91594495|NCT01133379|183079377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.856||0.488|TWO_SIDED|95.0|-7.62|3.66||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.66|-7.62|0.488
91594496|NCT01133379|183079377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.854||0.311|TWO_SIDED|95.0|-8.54|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||2.73|-8.54|0.311
91783591|NCT00535288|183447379|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.04||||0.29|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.29
91594497|NCT01133379|183079378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|3.478||0.604|TWO_SIDED|95.0|-8.68|5.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.06|-8.68|0.604
91594498|NCT01133379|183079378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.477||0.583|TWO_SIDED|95.0|-4.95|8.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.78|-4.95|0.583
91594499|NCT01133379|183079379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|3.61||0.847|TWO_SIDED|95.0|-7.83|6.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.43|-7.83|0.847
91594500|NCT01133379|183079379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|3.61||0.708|TWO_SIDED|95.0|-5.77|8.48||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.48|-5.77|0.708
91648818|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00092|STANDARD_ERROR_OF_MEAN|0.00079||0.2438|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2438
91522019|NCT03595332|182919008|EQUIVALENCE|The analysis tests whether for both groups combined, the baseline to 10-week follow-up BMI percentile scores are significantly different from zero.|Mean Difference (Final Values)|1.137|STANDARD_ERROR_OF_MEAN|0.9846||0.248|TWO_SIDED|95.0|-0.793|3.067||This test compares baseline to 10-week post-test for both groups combined, to test the null hypothesis that the BMI Percentile score would not be different from zero. A p-value of 0.05 was used as a priori threshold for statistical significance.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of 222 children nested within 150 families and 4 schools.||||3.067|-0.793|0.248
91594501|NCT01133379|183079380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.678||0.36|TWO_SIDED|95.0|-7.75|2.83||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.83|-7.75|0.360
91594502|NCT01133379|183079380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.679||0.149|TWO_SIDED|95.0|-9.17|1.41||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.41|-9.17|0.149
91594503|NCT01133379|183079381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|3.235||0.421|TWO_SIDED|95.0|-9.0|3.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.78|-9.00|0.421
91594504|NCT01133379|183079381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|STANDARD_ERROR_OF_MEAN|3.235||0.26|TWO_SIDED|95.0|-10.0|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.73|-10.0|0.260
91594505|NCT01133379|183079382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|3.601||0.989|TWO_SIDED|95.0|-7.16|7.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||7.06|-7.16|0.989
91594506|NCT01133379|183079382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|3.599||0.721|TWO_SIDED|95.0|-8.39|5.82||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.82|-8.39|0.721
91594507|NCT01133379|183079383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|STANDARD_ERROR_OF_MEAN|3.69||0.743|TWO_SIDED|95.0|-8.5|6.07||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.07|-8.50|0.743
91594508|NCT01133379|183079383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.688||0.928|TWO_SIDED|95.0|-7.61|6.95||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.95|-7.61|0.928
91594509|NCT01133379|183079384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.369||0.683|TWO_SIDED|95.0|-3.71|5.65||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.65|-3.71|0.683
91594510|NCT01133379|183079384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|2.371||0.914|TWO_SIDED|95.0|-4.94|4.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.42|-4.94|0.914
91594511|NCT01133379|183079385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.994||0.04|TWO_SIDED|95.0|-12.1|-0.27||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.27|-12.1|0.040
91783592|NCT00535288|183447379|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07||||0.02|TWO_SIDED|95.0|-0.14|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.14|0.02
91783593|NCT04643158|183447398|SUPERIORITY||Least Square Mean Difference|0.0236||||0.828|TWO_SIDED|95.0|-0.1934|0.2406|||Mixed Models Analysis|||||0.2406|-0.1934|0.828
91783594|NCT04643158|183447398|SUPERIORITY||Least Square Mean Difference|0.196||||0.035|TWO_SIDED|95.0|0.0143|0.3778|||Mixed Models Analysis|||||0.3778|0.0143|0.035
91594512|NCT01133379|183079385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.997||0.043|TWO_SIDED|95.0|-12.0|-0.18||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.18|-12.0|0.043
91594513|NCT01133379|183079386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|3.522||0.511|TWO_SIDED|95.0|-9.27|4.64||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.64|-9.27|0.511
91594514|NCT01133379|183079386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|3.526||0.25|TWO_SIDED|95.0|-11.0|2.89||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.89|-11.0|0.250
91709226|NCT01402986|183311366|SUPERIORITY_OR_OTHER||Rate Ratio|0.66||||0.245|TWO_SIDED|95.0|0.33|1.32|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.32|0.33|0.245
91783595|NCT04643158|183447418|SUPERIORITY||Geometric Least Square Mean Ratio|-38.31||||0.202|TWO_SIDED|95.0|-71.11|31.72|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||31.72|-71.11|0.202
91783596|NCT04643158|183447418|SUPERIORITY||Geometric Least Square Mean Ratio|-15.43||||0.596|TWO_SIDED|95.0|-55.57|60.96|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||60.96|-55.57|0.596
91783597|NCT02197078|183447424|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.03||||||||1.03|0.66|
91783598|NCT02197078|183447424|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.65|1.1||||||||1.10|0.65|
91783599|NCT02197078|183447424|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.49|0.86||||||||0.86|0.49|
91783600|NCT02197078|183447424|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.1||||||||1.10|0.83|
91783601|NCT02197078|183447424|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.85|1.19||||||||1.19|0.85|
91783602|NCT02197078|183447424|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.66|0.96||||||||0.96|0.66|
91783603|NCT02197078|183447425|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.23||||||||1.23|0.66|
91594515|NCT01133379|183079387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|STANDARD_ERROR_OF_MEAN|3.684||0.233|TWO_SIDED|95.0|-11.7|2.86||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.86|-11.7|0.233
91594516|NCT01133379|183079387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.84|STANDARD_ERROR_OF_MEAN|3.687||0.115|TWO_SIDED|95.0|-13.1|1.44||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.44|-13.1|0.115
91594517|NCT00841204|183079391|OTHER|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||||||0.0056
91594518|NCT00841204|183079392|OTHER|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||||||0.386
91594519|NCT00841204|183079393|OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
91594520|NCT00841204|183079394|OTHER|||||||0.58|||||||Regression, Linear|||||||0.58
91594521|NCT00841204|183079395|OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
91594522|NCT00255970|183079399|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.||||>.05
91594523|NCT00255970|183079399|SUPERIORITY_OR_OTHER||||||>|0.05||||||The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|ANOVA|||A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.||||>0.05
91594524|NCT00255970|183079400|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>.05
91594525|NCT00255970|183079401|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The change in recession, measured in mm, had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
91594526|NCT00255970|183079402|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.||||>0.05
91594527|NCT00255970|183079403|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
91594528|NCT00121108|183079406|SUPERIORITY||Relative risk|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Fisher Exact|||||0.21|0.08|<0.001
91594529|NCT03996876|183079417|SUPERIORITY|Given the relatively small sample size, results of our inferential statistical tests should be interpreted with caution.|F Statistic|1.032||||0.322|TWO_SIDED|||||The a priori threshold for statistical significance was set at 0.05.|ANOVA|We conducted a two-way mixed ANOVA with intervention as the between-subjects and time as the within-subjects variable.|The F Statistic reported is for the interaction between Intervention and Time.|||||0.322
91594530|NCT02726971|183079420|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91594531|NCT01380379|183079423|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|Single group comparison pre-post change score, compared to a value of 0 (no change)||||||<.01
91594532|NCT01380379|183079424|SUPERIORITY_OR_OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<.04
91594533|NCT00597753|183079433|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.3|-0.01|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin alfa group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||-0.01|-0.30|
91594534|NCT00597753|183079434|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.76|1.92|||Cochran-Mantel-Haenszel|||||1.92|0.76|
91594535|NCT00597753|183079435|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.97|||Cochran-Mantel-Haenszel|||||0.97|0.79|
91594536|NCT04342871|183079469|OTHER|Pre-post comparison from baseline to 2-weeks post-intervention||||||0.2|||||||t-test, 2 sided|||||||0.2
91594537|NCT01417195|183079487|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin for the lower limit of the 95% CI for the difference in fertilization rate was below -12%.|Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|-4.3|11.5|||||"Mean difference = Menopur/Bravelle - Menopur.~95% CI is based on Student's t-distribution, assuming equal variances."|||11.5|-4.3|
91594538|NCT02257372|183079509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|||<|0.001|TWO_SIDED|95.0|0.071|0.174|||Mixed model repeated measures analysis|||||0.174|0.071|<0.001
91594539|NCT02257372|183079510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|||<|0.001|TWO_SIDED|95.0|0.099|0.197|||Mixed model repeated measures analysis|||||0.197|0.099|<0.001
91594540|NCT02634151|183079511|SUPERIORITY||LS Mean Difference|-11.05||||0.0057|TWO_SIDED|95.0|-18.81|-3.29|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||A 2-sided test with a significance level of 0.05 was used for the comparison.||-3.29|-18.81|0.0057
91594541|NCT02634151|183079512|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.8||||0.0648|TWO_SIDED|95.0|-24.35|0.75|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||High-Intensity.||0.75|-24.35|0.0648
91594542|NCT02634151|183079512|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.64||||0.0398|TWO_SIDED|95.0|-20.77|-0.51|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||Moderate Intensity.||-0.51|-20.77|0.0398
91594543|NCT02634151|183079513|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.09||||0.0275|TWO_SIDED|95.0|-19.04|-1.14|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.14|-19.04|0.0275
91594544|NCT02634151|183079513|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.4||||0.0524|TWO_SIDED|95.0|-18.9|0.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4.||0.10|-18.90|0.0524
91594545|NCT02634151|183079513|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.89||||0.8602|TWO_SIDED|95.0|-9.12|10.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||10.90|-9.12|0.8602
91594546|NCT02634151|183079513|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.63||||0.0115|TWO_SIDED|95.0|-22.37|-2.89|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-2.89|-22.37|0.0115
91594547|NCT02634151|183079513|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.87||||0.1945|TWO_SIDED|95.0|-14.79|3.05|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Average of week 8 and 12||3.05|-14.79|0.1945
91594548|NCT02634151|183079514|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.88||||0.0991|TWO_SIDED|95.0|-12.89|1.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.13|-12.89|0.0991
91594549|NCT02634151|183079515|OTHER|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.58||||0.0101|TWO_SIDED|95.0|-13.32|-1.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.84|-13.32|0.0101
91709227|NCT01402986|183311366|SUPERIORITY_OR_OTHER||Rate Ratio|0.76||||0.438|TWO_SIDED|95.0|0.37|1.54|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.54|0.37|0.438
91594550|NCT02634151|183079515|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.56||||0.0037|TWO_SIDED|95.0|-15.94|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.18|-15.94|0.0037
91594551|NCT02634151|183079515|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.94||||0.7839|TWO_SIDED|95.0|-7.72|5.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.84|-7.72|0.7839
91594552|NCT02634151|183079515|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.69||||0.0025|TWO_SIDED|95.0|-17.53|-3.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.84|-17.53|0.0025
91594553|NCT02634151|183079516|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.66||||0.0117|TWO_SIDED|95.0|-22.45|-2.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.88|-22.45|0.0117
91594554|NCT02634151|183079516|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.55||||0.0036|TWO_SIDED|95.0|-25.88|-5.21|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.21|-25.88|0.0036
91594555|NCT02634151|183079516|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.59||||0.9147|TWO_SIDED|95.0|-11.48|10.31||Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.|ANCOVA|||Week 8||10.31|-11.48|0.9147
91594556|NCT02634151|183079516|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.59||||0.0026|TWO_SIDED|95.0|-27.24|-5.93|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.93|-27.24|0.0026
91594557|NCT02634151|183079517|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.13||||0.0101|TWO_SIDED|95.0|-10.77|-1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.50|-10.77|0.0101
91594558|NCT02634151|183079517|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.73||||0.0036|TWO_SIDED|95.0|-12.89|-2.58|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-2.58|-12.89|0.0036
91594559|NCT02634151|183079517|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.12||||0.9653|TWO_SIDED|95.0|-5.27|5.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.51|-5.27|0.9653
91594560|NCT02634151|183079517|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.89||||0.0101|TWO_SIDED|95.0|-12.1|-1.68|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.68|-12.10|0.0101
91594561|NCT02634151|183079518|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.74||||0.0173|TWO_SIDED|95.0|-23.19|-2.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.30|-23.19|0.0173
91594562|NCT02634151|183079518|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.29||||0.0038|TWO_SIDED|95.0|-27.17|-5.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.40|-27.17|0.0038
91594563|NCT02634151|183079518|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.58||||0.7846|TWO_SIDED|95.0|-9.85|13.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||13.01|-9.85|0.7846
91594564|NCT02634151|183079518|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.98||||0.0121|TWO_SIDED|95.0|-24.83|-3.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.13|-24.83|0.0121
91594565|NCT02634151|183079519|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.32||||0.0108|TWO_SIDED|95.0|-23.32|-3.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-3.12|-23.32|0.0108
91594566|NCT02634151|183079519|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.78|-12.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.42|-34.78|<0.0001
91594567|NCT02634151|183079519|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.71||||0.1376|TWO_SIDED|95.0|-15.6|2.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.18|-15.60|0.1376
91709228|NCT01402986|183311366|SUPERIORITY_OR_OTHER||Rate Ratio|1.01||||0.947|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.57|0.66|0.947
91594568|NCT02634151|183079519|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.64||||0.0144|TWO_SIDED|95.0|-28.1|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||-3.18|-28.10|0.0144
91594569|NCT02634151|183079520|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-19.53||||0.0113|TWO_SIDED|95.0|-34.55|-4.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-4.51|-34.55|0.0113
91594570|NCT02634151|183079520|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-33.64||||0.0002|TWO_SIDED|95.0|-50.58|-16.69|||ANCOVA|||Week 4||-16.69|-50.58|0.0002
91594571|NCT02634151|183079520|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-8.33||||0.1873|TWO_SIDED|95.0|-20.77|4.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.12|-20.77|0.1873
91594572|NCT02634151|183079520|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-29.58||||0.0172|TWO_SIDED|95.0|-53.8|-5.37|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.37|-53.80|0.0172
91594573|NCT02634151|183079521|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.52||||0.021|TWO_SIDED|95.0|-21.27|-1.77|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.77|-21.27|0.0210
91594574|NCT02634151|183079521|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.01|||<|0.0001|TWO_SIDED|95.0|-34.02|-12.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.01|-34.02|<0.0001
91594575|NCT02634151|183079521|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.43||||0.1483|TWO_SIDED|95.0|-15.19|2.33|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.33|-15.19|0.1483
91594576|NCT02634151|183079521|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.63||||0.0214|TWO_SIDED|95.0|-21.5|-1.76|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.76|-21.50|0.0214
91783604|NCT02197078|183447425|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
91594577|NCT02634151|183079522|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.95||||0.0308|TWO_SIDED|95.0|-5.62|-0.28|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-0.28|-5.62|0.0308
91594578|NCT02634151|183079522|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.3||||0.0002|TWO_SIDED|95.0|-9.56|-3.04|||ANCOVA|A 2-sided test with a significance level of 0.05 was used for the comparison.||Week 4||-3.04|-9.56|0.0002
91594579|NCT02634151|183079522|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.58||||0.2056|TWO_SIDED|95.0|-4.03|0.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.88|-4.03|0.2056
91594580|NCT02634151|183079522|SUPERIORITY||LS Mean Difference|-4.0||||0.0103|TWO_SIDED|95.0|-7.04|-0.96|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.96|-7.04|0.0103
91594581|NCT02634151|183079523|SUPERIORITY||LS Mean Difference|-2.13||||0.3193|TWO_SIDED|95.0|-6.36|2.09|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||2.09|-6.36|0.3193
91594582|NCT02634151|183079523|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.4||||0.2932|TWO_SIDED|95.0|-6.91|2.11|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.11|-6.91|0.2932
91594583|NCT02634151|183079523|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.98||||0.4383|TWO_SIDED|95.0|-3.06|7.02|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.02|-3.06|0.4383
91594584|NCT02634151|183079523|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|2.78||||0.2814|TWO_SIDED|95.0|-2.31|7.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.86|-2.31|0.2814
91594585|NCT02634151|183079524|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.92||||0.4278|TWO_SIDED|95.0|-3.23|1.38|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||1.38|-3.23|0.4278
91594586|NCT02634151|183079524|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.13||||0.3529|TWO_SIDED|95.0|-3.53|1.27|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.27|-3.53|0.3529
91594587|NCT02634151|183079524|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.24||||0.3522|TWO_SIDED|95.0|-1.39|3.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.86|-1.39|0.3522
91594588|NCT02634151|183079524|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.6||||0.2635|TWO_SIDED|95.0|-1.22|4.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.42|-1.22|0.2635
91594589|NCT02634151|183079525|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.23||||0.0464|TWO_SIDED|95.0|1.01|4.93|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.93|1.01|0.0464
91594590|NCT02634151|183079525|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.3||||0.5278|TWO_SIDED|95.0|0.58|2.92|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.92|0.58|0.5278
91594591|NCT02634151|183079525|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.36||||0.0359|TWO_SIDED|95.0|1.06|5.27|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.27|1.06|0.0359
91594592|NCT02634151|183079526|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.5||||0.0268|TWO_SIDED|95.0|1.11|5.61|||Regression, Logistic|||Week 4||5.61|1.11|0.0268
91594593|NCT02634151|183079526|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2755|TWO_SIDED|95.0|0.7|3.41|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.41|0.70|0.2755
91648819|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000304|STANDARD_ERROR_OF_MEAN|0.000885||0.7317|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7317
91594594|NCT02634151|183079526|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|4.74||||0.0003|TWO_SIDED|95.0|2.05|10.94|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||10.94|2.05|0.0003
91594595|NCT02634151|183079527|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.26||||0.0079|TWO_SIDED|95.0|1.36|7.8|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||7.80|1.36|0.0079
91709229|NCT01402986|183311366|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.916|TWO_SIDED|95.0|0.59|1.59|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.59|0.59|0.916
91648820|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00062|STANDARD_ERROR_OF_MEAN|0.001327||0.6393|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6393
91648821|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00112|STANDARD_ERROR_OF_MEAN|0.000873||0.1995|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1995
91783605|NCT02197078|183447425|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.01||||||||1.01|0.48|
91594596|NCT02634151|183079527|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.44||||0.4002|TWO_SIDED|95.0|0.62|3.35|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.35|0.62|0.4002
91594597|NCT02634151|183079527|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.09||||0.0142|TWO_SIDED|95.0|1.25|7.59|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.59|1.25|0.0142
91594598|NCT02634151|183079528|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.7||||0.0115|TWO_SIDED|95.0|1.34|10.2|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||10.20|1.34|0.0115
91594599|NCT02634151|183079528|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.15||||0.7566|TWO_SIDED|95.0|0.48|2.75|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.75|0.48|0.7566
91594600|NCT02634151|183079528|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.96||||0.0298|TWO_SIDED|95.0|1.11|7.88|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.88|1.11|0.0298
91594601|NCT02634151|183079529|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.4||||0.0029|TWO_SIDED|95.0|-17.2|-3.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.7|-17.2|0.0029
91594602|NCT02634151|183079529|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-4.3||||0.1666|TWO_SIDED|95.0|-10.4|1.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.8|-10.4|0.1666
91594603|NCT02634151|183079529|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.5||||0.001|TWO_SIDED|95.0|-18.2|-4.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.8|-18.2|0.0010
91594604|NCT02634151|183079530|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.7||||0.0018|TWO_SIDED|95.0|-17.3|-4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-4.1|-17.3|0.0018
91709230|NCT01402986|183311367|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.56|0.52|0.723
91783606|NCT02197078|183447425|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
91783607|NCT02197078|183447425|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.28||||||||1.28|0.79|
91594605|NCT02634151|183079530|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.8||||0.2437|TWO_SIDED|95.0|-10.1|2.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.6|-10.1|0.2437
91594606|NCT02634151|183079530|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.6||||0.0012|TWO_SIDED|95.0|-18.5|-4.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.7|-18.5|0.0012
91594607|NCT02634151|183079531|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.6832|TWO_SIDED|95.0|-4.2|2.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.8|-4.2|0.6832
91594608|NCT02634151|183079531|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.674|TWO_SIDED|95.0|-2.9|4.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.5|-2.9|0.6740
91594609|NCT02634151|183079531|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.3379|TWO_SIDED|95.0|-2.0|5.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.7|-2.0|0.3379
91648822|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00072|STANDARD_ERROR_OF_MEAN|0.000675||0.2886|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2886
91783608|NCT02197078|183447425|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.06||||||||1.06|0.62|
91783609|NCT02197078|183447426|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.51|0.94||||||||0.94|0.51|
91522020|NCT03595332|182919009|EQUIVALENCE|Analysis tested whether BMI Percentile score change among overweight participants (BMI equal or greater than 85th percentile at baseline) significantly changed from baseline to follow-up (was significantly different from zero). This was a subset analysis among the highest risk participants in the study.|Mean Difference (Final Values)|-3.173|STANDARD_ERROR_OF_MEAN|1.34||0.018|TWO_SIDED|95.0|-5.806|-0.541||The p-value threshold was 0.05 for all comparisons.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of children within schools and families.|A negative parameter suggests a decreased BMI Percentile.|||-0.541|-5.806|0.018
91522021|NCT03595332|182919010|EQUIVALENCE|Analysis tested the difference in BMI percentile between baseline and 1-year follow-up among participants in the immediate intervention group to test the null hypothesis that no change occurred.|Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|1.676||0.829|TWO_SIDED|95.0|-2.922|3.648||A prior threshold for statistical significance was 0.05. No adjustment for multiple comparisons was made.|Regression, Linear|Analysis included Generalized Estimating Equations with linear response variable, accounting for nested data structure.||||3.648|-2.922|0.829
91522022|NCT03595332|182919011|EQUIVALENCE|Analysis test whether for both groups combined, Baseline to 10-week change in reported intention of physical activity was significantly different from zero.|Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.128||0.026|TWO_SIDED|95.0|0.034|0.534||A priori threshold for statistical significance is 0.05. No adjustments for multiple comparisons were made.|Regression, Linear|Linear regression models with Generalized Estimating Equations to account for nested data were made.|A positive parameter would suggest an increase in intentions to be physically active.|||0.534|0.034|0.026
91522023|NCT02227875|182919012|NON_INFERIORITY|Mixed-Effect Model for Repeated Measures|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.098|0.218||||||||0.218|-0.098|
91522024|NCT01069354|182919168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41|||<|0.0001|TWO_SIDED|||||Paired t-test|t-test, 2 sided|||||||<0.0001
91522025|NCT01069354|182919169|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Binomial proportion, two-sided Fisher's exact test|Fisher Exact|||91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0||||<0.0001
91522026|NCT01069354|182919170|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
91522027|NCT01069354|182919171|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
91522028|NCT01069354|182919172|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
91709231|NCT01402986|183311367|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.852|TWO_SIDED|95.0|0.6|1.86|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.86|0.60|0.852
91783610|NCT02197078|183447426|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9||||||||0.90|0.44|
91522029|NCT01069354|182919173|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
91783611|NCT02197078|183447426|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.41|0.88||||||||0.88|0.41|
91783612|NCT02197078|183447426|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
91522030|NCT01069354|182919174|SUPERIORITY_OR_OTHER|||||||0.5663||||||Paired t-test|t-test, 2 sided|||||||0.5663
91522031|NCT01069354|182919175|SUPERIORITY_OR_OTHER|||||||0.3197||||||Paired t-test|t-test, 2 sided|||||||0.3197
91522032|NCT03138733|182919178|NON_INFERIORITY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two sided 95% CI for the difference in response rates in the mITT population was greater than -15%, the non-inferiority of ceftobiprole to daptomycin therapy was to be concluded.|Adjusted proportion difference|2.0|||||TWO_SIDED|95.0|-7.1|11.1||||||The observed difference in percentage of responders at PTE (ceftobiprole group minus the daptomycin group) were determined and a two-sided 95% confidence interval (CI) for the observed difference was computed, with adjustment for actual stratum (dialysis status and prior antibacterial treatment use). Cochran-Mantel-Haenszel (CMH) weights were used for the stratum weight in the calculation of the CI||11.1|-7.1|
91522033|NCT03138733|182919179|OTHER||Adjusted proportion difference|0.6|||||TWO_SIDED|95.0|-8.3|9.5|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||9.5|-8.3|
91522034|NCT03138733|182919180|OTHER||Adjusted proportion difference|5.1|||||TWO_SIDED|95.0|-2.9|13.0|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||13|-2.9|
91522035|NCT03138733|182919181|OTHER||Adjusted proportion difference|-0.5|||||TWO_SIDED|95.0|-6.2|5.2|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||5.2|-6.2|
91783613|NCT02197078|183447426|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||||1.19|0.77|
91783614|NCT02197078|183447426|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
91783615|NCT02197078|183447427|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.58|1.38||||||||1.38|0.58|
91783616|NCT02197078|183447427|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
91783617|NCT02197078|183447427|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.24|0.78||||||||0.78|0.24|
91783618|NCT02197078|183447427|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.73|1.25||||||||1.25|0.73|
91783619|NCT02197078|183447427|OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.78|1.52||||||||1.52|0.78|
91594610|NCT02634151|183079532|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.7753|TWO_SIDED|95.0|-5.9|4.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.4|-5.9|0.7753
91783620|NCT02197078|183447427|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05||||||||1.05|0.52|
91783621|NCT02197078|183447428|OTHER||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.1|2.18||||||||2.18|1.10|
91783622|NCT02197078|183447428|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.19|3.03||||||||3.03|1.19|
91783623|NCT02197078|183447428|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||||1.68|0.73|
91783624|NCT02197078|183447428|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.76|1.29||||||||1.29|0.76|
91783625|NCT02197078|183447428|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.77|1.56||||||||1.56|0.77|
91783626|NCT02197078|183447428|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14||||||||1.14|0.54|
91783627|NCT02197078|183447429|OTHER||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.97|2.0||||||||2.00|0.97|
91783628|NCT02197078|183447429|OTHER||Hazard Ratio (HR)|1.71|||||TWO_SIDED|95.0|1.07|2.72||||||||2.72|1.07|
91783629|NCT02197078|183447429|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
91783630|NCT02197078|183447429|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|1.01|1.76||||||||1.76|1.01|
91783631|NCT02197078|183447429|OTHER||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27||||||||2.27|1.02|
91783632|NCT02197078|183447429|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.81|1.71||||||||1.71|0.81|
91783633|NCT02197078|183447430|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.04|1.47||||||||1.47|1.04|
91783634|NCT02197078|183447430|OTHER||Hazard Ratio (HR)|1.31|||||TWO_SIDED|95.0|1.06|1.61||||||||1.61|1.06|
91783635|NCT02197078|183447430|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
91783636|NCT02197078|183447430|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
91783637|NCT02197078|183447430|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||||1.27|0.90|
91783638|NCT02197078|183447430|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.75|1.09||||||||1.09|0.75|
91783639|NCT02197078|183447431|OTHER||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.64|4.06||||||||4.06|0.64|
91783640|NCT02197078|183447431|OTHER||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.61|4.58||||||||4.58|0.61|
91783641|NCT02197078|183447431|OTHER||Hazard Ratio (HR)|1.84|||||TWO_SIDED|95.0|0.62|5.48||||||||5.48|0.62|
91783642|NCT02197078|183447431|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.57|2.4||||||||2.40|0.57|
91783643|NCT02197078|183447431|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.38|2.43||||||||2.43|0.38|
91783644|NCT02197078|183447431|OTHER||Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.64|4.27||||||||4.27|0.64|
91783645|NCT00622440|183447432|OTHER||Wilcoxon Rank Sum Effect Size|0.275||||0.042|TWO_SIDED|95.0|||||Wilcoxon rank sum||The wilcoxon rank sum effect size ranges in strength of effect from small (0.10 - \< 0.30), to medium (0.30 - \< 0.50), to large (\>=0.50) with a total range of 0 to 1|Estimated Effect Size for Phase 3 Trial||||.042
91783646|NCT02223377|183447436|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.56|1.78|||Regression, Logistic|||||1.78|0.56|0.997
91783647|NCT02223377|183447441|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.04|TWO_SIDED|95.0|-1.43|-0.03|||ANOVA|||||-0.03|-1.43|0.040
91783648|NCT06026124|183447461|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783649|NCT06026124|183447461|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783650|NCT06026124|183447462|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783651|NCT06026124|183447462|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783652|NCT06026124|183447463|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783653|NCT06026124|183447463|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783654|NCT06026124|183447464|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
91783655|NCT06026124|183447464|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91783656|NCT06026124|183447465|SUPERIORITY||||||=|0.17|||||||LSD test|||||||=0.17
91783657|NCT06026124|183447465|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
91783658|NCT06026124|183447466|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
91783659|NCT06026124|183447467|SUPERIORITY||||||=|0.51|||||||LSD test|||||||=0.51
91783660|NCT03023813|183447470|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
91783661|NCT03023813|183447471|OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
91783662|NCT03023813|183447472|OTHER|||||||0.39|||||||t-test, 2 sided|||||||.39
91783663|NCT03023813|183447473|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
91783664|NCT03023813|183447474|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
91783665|NCT03023813|183447475|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
91783666|NCT03023813|183447476|OTHER|Percent change in weight (lbs.) since the baseline encounter|Mean Difference (Net)|-2.96||||0.27|TWO_SIDED|95.0|-8.18|2.26|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included weight loss||2.26|-8.18|0.27
91783667|NCT03023813|183447476|OTHER|Change in systolic blood pressure since the baseline encounter (mmHg)|Mean Difference (Net)|-6.42||||0.19|TWO_SIDED|95.0|-16.12|3.27|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included blood pressure control||3.27|-16.12|0.19
91783668|NCT03023813|183447476|OTHER|Percentage point change in HbA1c (%) since the baseline encounter|Mean Difference (Net)|-0.68||||0.24|TWO_SIDED|95.0|-1.82|0.45|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included glycemic control||0.45|-1.82|0.24
91648823|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002048|STANDARD_ERROR_OF_MEAN|0.001356||0.1323|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1323
91648824|NCT03593772|183190406|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000209|STANDARD_ERROR_OF_MEAN|0.000793||0.7923|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7923
91648825|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00046|STANDARD_ERROR_OF_MEAN|0.001074||0.6679|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6679
91648826|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001083|STANDARD_ERROR_OF_MEAN|0.000769||0.1607|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1607
91648827|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000984|STANDARD_ERROR_OF_MEAN|0.00064||0.126|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1260
91648828|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000909|STANDARD_ERROR_OF_MEAN|0.000933||0.3311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3311
91648829|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001041|STANDARD_ERROR_OF_MEAN|0.000887||0.2416|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2416
91648830|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00087|STANDARD_ERROR_OF_MEAN|0.001016||0.3903|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3903
91648831|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001186|STANDARD_ERROR_OF_MEAN|0.00095||0.2131|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2131
91709232|NCT01402986|183311367|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.409|TWO_SIDED|95.0|0.6|1.23|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.23|0.60|0.409
91790385|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.468|TWO_SIDED|95.0|-0.272|0.125||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.125|-0.272|0.468
91522036|NCT03138733|182919182|OTHER||Adjusted proportion difference|0.1|||||TWO_SIDED|95.0|-4.6|4.8|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||4.8|-4.6|
91522037|NCT02521285|182919202|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
91522038|NCT02521285|182919202|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||||||0.149
91522039|NCT02521285|182919203|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
91522040|NCT02521285|182919204|SUPERIORITY|||||||0.382|||||||t-test, 2 sided|||||||0.382
91522041|NCT02521285|182919204|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91522042|NCT02521285|182919205|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
91522043|NCT02521285|182919205|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91522044|NCT02521285|182919206|SUPERIORITY|||||||0.234|||||||t-test, 2 sided|||||||0.234
91522045|NCT02521285|182919206|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||0.442
91522046|NCT02521285|182919207|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|||||||0.645
91522047|NCT02521285|182919207|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
91522048|NCT02521285|182919215|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
91522049|NCT02521285|182919216|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||Difference between arms||||0.397
91522050|NCT02521285|182919216|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||Difference in arms.||||0.983
91522051|NCT02521285|182919217|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
91522052|NCT02521285|182919217|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||0.203
91522053|NCT02521285|182919218|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
91522054|NCT02521285|182919218|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
91522055|NCT02521285|182919219|SUPERIORITY|||||||0.281|||||||t-test, 2 sided|||||||0.281
91522056|NCT02521285|182919219|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
91522057|NCT02521285|182919220|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
91522058|NCT02521285|182919220|SUPERIORITY|||||||0.195|||||||t-test, 2 sided|||||||0.195
91522059|NCT02521285|182919221|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
91522060|NCT02521285|182919221|SUPERIORITY|||||||0.432|||||||t-test, 2 sided|||||||0.432
91522061|NCT02521285|182919222|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
91522062|NCT02521285|182919222|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
91522063|NCT02521285|182919223|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
91522064|NCT02521285|182919223|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
91522065|NCT02521285|182919226|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|||||||0.518
91522066|NCT02521285|182919227|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
91522067|NCT02521285|182919227|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||||||0.505
91522068|NCT02521285|182919228|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
91522069|NCT02521285|182919228|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
91522070|NCT02521285|182919229|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
91522071|NCT02521285|182919229|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91648832|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001485|STANDARD_ERROR_OF_MEAN|0.000933||0.113|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1130
91648833|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001983|STANDARD_ERROR_OF_MEAN|0.000939||0.0358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0358
91648834|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00019|STANDARD_ERROR_OF_MEAN|0.000495||0.7027|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7027
91648835|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000761|STANDARD_ERROR_OF_MEAN|0.00073||0.2979|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2979
91648836|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00063|STANDARD_ERROR_OF_MEAN|0.000798||0.4278|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4278
91648837|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0000074|STANDARD_ERROR_OF_MEAN|0.000877||0.9933|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9933
91709233|NCT01402986|183311367|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.744|TWO_SIDED|95.0|0.72|1.58|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.58|0.72|0.744
91783669|NCT03023813|183447476|OTHER|Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter|Mean Difference (Net)|-1.2||||0.34|TWO_SIDED|95.0|-3.65|1.26|||Generalized linear mixed regression||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||1.26|-3.65|0.34
91783670|NCT03023813|183447476|OTHER|Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter|Mean Difference (Net)|-8.46||||0.36|TWO_SIDED|95.0|-26.63|9.7|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||9.70|-26.63|0.36
91790386|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790387|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.104||0.636|TWO_SIDED|95.0|-0.155|0.254||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.254|-0.155|0.636
91790388|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790389|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.112||0.887|TWO_SIDED|95.0|-0.204|0.236||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.236|-0.204|0.887
91790390|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91594611|NCT02634151|183079532|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.5472|TWO_SIDED|95.0|-3.9|7.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.4|-3.9|0.5472
91594612|NCT02634151|183079532|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|3.6||||0.2406|TWO_SIDED|95.0|-2.4|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.6|-2.4|0.2406
91594613|NCT02634151|183079533|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9028|TWO_SIDED|95.0|-3.3|3.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||3.8|-3.3|0.9028
91594614|NCT02634151|183079533|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|5.2||||0.0199|TWO_SIDED|95.0|0.8|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||9.6|0.8|0.0199
91594615|NCT02634151|183079533|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.6||||0.0369|TWO_SIDED|95.0|0.3|8.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||8.9|0.3|0.0369
91594616|NCT02634151|183079534|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.1||||0.911|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.4|-1.2|0.9110
91594617|NCT02634151|183079534|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.0243|TWO_SIDED|95.0|0.3|3.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.5|0.3|0.0243
91648838|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00115|STANDARD_ERROR_OF_MEAN|0.000816||0.1589|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1589
91783671|NCT03023813|183447476|OTHER|Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter.|Odds Ratio (OR)|1.2||||0.92|TWO_SIDED|95.0|0.03|45.56|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. OR \<1 indicates reduction in smoking intensity; OR \>1 indicates increase in smoking intensity.|Among participants whose individualized preventive care recommendations included tobacco cessation||45.56|0.03|0.92
91522072|NCT05701995|182919242|SUPERIORITY||Odds Ratio (OR)|7.7||||0.0001|TWO_SIDED|95.0|2.5|23.6|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||23.6|2.5|0.0001
91594618|NCT02634151|183079534|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.0388|TWO_SIDED|95.0|0.1|3.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||3.2|0.1|0.0388
91594619|NCT02634151|183079535|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|7.0||||0.2799|TWO_SIDED|95.0|-5.7|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-5.7|0.2799
91594620|NCT02634151|183079535|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|26.8||||0.0018|TWO_SIDED|95.0|10.2|43.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||43.3|10.2|0.0018
91594621|NCT02634151|183079535|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|20.1||||0.0197|TWO_SIDED|95.0|3.3|36.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||36.9|3.3|0.0197
91522073|NCT05701995|182919242|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0003|TWO_SIDED|95.0|2.4|30.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||30.4|2.4|0.0003
91594622|NCT02634151|183079536|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.6||||0.0179|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.0|0.1|0.0179
91594623|NCT02634151|183079536|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.1||||0.0003|TWO_SIDED|95.0|0.5|1.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.7|0.5|0.0003
91594624|NCT02634151|183079536|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.0095|TWO_SIDED|95.0|0.2|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||1.5|0.2|0.0095
91594625|NCT02634151|183079537|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.2||||0.0057|TWO_SIDED|95.0|-20.8|-3.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.6|-20.8|0.0057
91648839|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000109|STANDARD_ERROR_OF_MEAN|0.000767||0.8875|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8875
91783672|NCT03023813|183447476|OTHER|Receipt of colorectal cancer screening since the baseline encounter|Odds Ratio (OR)|2.52||||0.99|TWO_SIDED|95.0|0.001|1000.0|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. Lower limit estimate was \<0.001 and upper limit estimate was \>1000 (ClinicalTrials.gov does not allow \< or \> to be entered into the confidence interval lower limit or upper limit fields).|Among participants whose individualized preventive care recommendations included colorectal cancer screening||1000|0.001|0.99
91783673|NCT02283762|183447491|SUPERIORITY||Difference of LS means|-2.34||||0.0815|TWO_SIDED|95.0|-4.99|0.3|||MMRM (Method 1)|||||0.30|-4.99|0.0815
91522074|NCT05701995|182919243|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0107|TWO_SIDED|95.0|1.2|4.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||4.4|1.2|0.0107
91522075|NCT05701995|182919243|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0175|TWO_SIDED|95.0|1.2|4.7|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||4.7|1.2|0.0175
91522076|NCT05701995|182919244|SUPERIORITY||Adjusted Mean Difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.2|||Covariance model|||Full Analysis Set||-1.2|-2.9|<0.0001
91522077|NCT05701995|182919244|SUPERIORITY||Adjusted Mean Difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.3|||Covariance model|||Full Analysis Set Sub-population||-1.3|-3.0|<0.0001
91522078|NCT05701995|182919245|SUPERIORITY||Odds Ratio (OR)|5.9||||0.0004|TWO_SIDED|95.0|2.0|17.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||17.4|2.0|0.0004
91522079|NCT00715429|182919252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||||||Daily cramp rate at baseline\& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.|t-test, 2 sided|T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.||||||0.27
91522080|NCT00406133|182919254|SUPERIORITY_OR_OTHER|||||||0.29||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age 8-14 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.||||0.29
91594626|NCT02634151|183079537|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9665|TWO_SIDED|95.0|-8.3|8.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||8.6|-8.3|0.9665
91594627|NCT02634151|183079537|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.2||||0.2358|TWO_SIDED|95.0|-16.4|4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.1|-16.4|0.2358
91594628|NCT02634151|183079538|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.3||||0.0048|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.4|-2.3|0.0048
91594629|NCT02634151|183079538|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.1||||0.9064|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.8|-0.9|0.9064
91783674|NCT02283762|183447492|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|%|0.2||||0.977|TWO_SIDED|95.0|-13.68|14.09|||Mantel Haenszel|||||14.09|-13.68|0.9770
91783675|NCT02283762|183447493|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.07||||0.3529|TWO_SIDED|95.0|-0.23|0.08|||MMRM (Method 1)|||change from baseline||0.08|-0.23|0.3529
91522081|NCT00406133|182919254|SUPERIORITY_OR_OTHER|||||||0.52||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value for age 15-24 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||0.52
91522082|NCT00406133|182919254|SUPERIORITY_OR_OTHER||||||<|0.001||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age \>=25 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||<0.001
91522083|NCT00406133|182919255|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value was for the comparison of RT-CGM group and Control group.|ANCOVA|Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.||||0.16
91709234|NCT01402986|183311368|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.802|TWO_SIDED|95.0|0.58|1.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.52|0.58|0.802
91783676|NCT02283762|183447494|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.79||||0.0887|TWO_SIDED|95.0|-0.12|1.69|||MMRM (Method 1)|||Change from baseline||1.69|-0.12|0.0887
91522084|NCT00406133|182919256|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
91522085|NCT00406133|182919256|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 15-24 year age group.|Fisher Exact|||||||0.48
91522086|NCT00406133|182919256|SUPERIORITY_OR_OTHER|||||||1||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the \>=25 year age group.|Fisher Exact|||||||1.0
91522087|NCT00406133|182919256|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
91522088|NCT00406133|182919256|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 15-24 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.48
91594630|NCT02634151|183079538|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.2505|TWO_SIDED|95.0|-1.7|0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||0.4|-1.7|0.2505
91594631|NCT02634151|183079539|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-9.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-9.0|-22.6|<0.0001
91594632|NCT02634151|183079539|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.2||||0.0406|TWO_SIDED|95.0|-14.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||-0.3|-14.0|0.0406
91594633|NCT02634151|183079539|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-22.8|-7.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-7.8|-22.8|<0.0001
91709235|NCT01402986|183311368|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.05|TWO_SIDED|95.0|0.36|1.0|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.00|0.36|0.050
91783677|NCT02283762|183447495|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.83||||0.0241|TWO_SIDED|95.0|0.11|1.54|||MMRM (Method 1)|||Change from baseline||1.54|0.11|0.0241
91783678|NCT02283762|183447496|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.2||||0.901|TWO_SIDED|95.0|-3.4|3.0|||MMRM (Method 1)|||change from baseline||3.00|-3.40|0.9010
91783679|NCT00202878|183447497|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.016|TWO_SIDED|95.0|0.887|0.988|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.988|0.887|0.016
91783680|NCT00202878|183447498|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.948||||0.035|TWO_SIDED|95.0|0.903|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.996|0.903|0.035
91594634|NCT02634151|183079540|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.3|-0.9|<0.0001
91594635|NCT02634151|183079540|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.3||||0.0771|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.0|-0.6|0.0771
91594636|NCT02634151|183079540|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.0006|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.3|-1.0|0.0006
91594637|NCT02634151|183079541|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.6||||0.121|TWO_SIDED|95.0|-2.3|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-2.3|0.1210
91594638|NCT02634151|183079541|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.0||||0.0948|TWO_SIDED|95.0|-1.4|17.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||17.3|-1.4|0.0948
91709236|NCT01402986|183311368|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.792|TWO_SIDED|95.0|0.56|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||1.56|0.56|0.792
91594639|NCT02634151|183079541|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.1||||0.5113|TWO_SIDED|95.0|-8.2|16.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||16.4|-8.2|0.5113
91594640|NCT02634151|183079542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.7276|TWO_SIDED|95.0|-7.8|11.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||11.1|-7.8|0.7276
91594641|NCT02634151|183079542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.7||||0.2218|TWO_SIDED|95.0|-2.9|12.2|||ANCOVA|||Week 8||12.2|-2.9|0.2218
91594642|NCT02634151|183079542|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.3||||0.942|TWO_SIDED|95.0|-9.2|9.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.8|-9.2|0.9420
91594643|NCT02634151|183079543|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|32.57||||0.6786|TWO_SIDED|95.0|-122.98|188.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||188.12|-122.98|0.6786
91594644|NCT02634151|183079544|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.84||||0.1648|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.35|-2.03|0.1648
91594645|NCT02634151|183079545|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|41.5||||0.4701|TWO_SIDED|95.0|-72.1|155.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||155.1|-72.1|0.4701
91594646|NCT02634151|183079546|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-32.4||||0.0517|TWO_SIDED|95.0|-65.1|0.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.2|-65.1|0.0517
91594647|NCT02634151|183079547|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.5||||0.9111|TWO_SIDED|95.0|-177.8|158.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||158.8|-177.8|0.9111
91594648|NCT02634151|183079548|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.0||||0.3864|TWO_SIDED|95.0|-10.0|3.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||3.9|-10.0|0.3864
91594649|NCT02634151|183079549|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|12.2||||0.0145|TWO_SIDED|95.0|2.5|22.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||22.0|2.5|0.0145
91594650|NCT02634151|183079550|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.051|TWO_SIDED|95.0|0.0|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.5|-0.0|0.0510
91594651|NCT01040351|183079564|NON_INFERIORITY_OR_EQUIVALENCE|. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)|Odds Ratio (OR)|3.02||||0.023|TWO_SIDED|95.0|1.13|8.0|||Chi-squared|||||8.0|1.13|0.023
91594652|NCT03503877|183079589|SUPERIORITY|||||||0.07|||||||Wilcoxon signed-rank testing|||||||0.07
91594653|NCT03503877|183079590|SUPERIORITY|||||||0.89|||||||Wilcoxon signed-rank testing|||||||0.89
91594654|NCT03503877|183079591|SUPERIORITY|||||||0.54||||||High mosaicism|Wilcoxon signed-rank testing|||||||0.54
91594655|NCT03503877|183079591|SUPERIORITY|||||||0.2||||||Low mosaicism|Wilcoxon signed-rank|||||||.20
91594656|NCT03503877|183079592|SUPERIORITY|||||||0.01||||||Time to Expanded Blastocyst|Wilcoxon signed-rank testing|||||||0.01
91594657|NCT01977599|183079593|OTHER|Chi Square|||||<|0.001|||||||Chi-squared|||||||<0.001
91594658|NCT02700412|183079598|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
91648840|NCT03593772|183190407|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00032|STANDARD_ERROR_OF_MEAN|0.00078||0.6859|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6859
91648841|NCT03593772|183190408|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01408|STANDARD_ERROR_OF_MEAN|0.01085||0.1959|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on BDI total score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1959
91648842|NCT03593772|183190409|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00788|STANDARD_ERROR_OF_MEAN|0.005845||0.1792|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Perceived Stress Scale Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1792
91594659|NCT02700412|183079599|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
91594660|NCT04416555|183079611|SUPERIORITY|||||||0.391|||||||Mixed Models Analysis|||||||0.391
91648843|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00132|STANDARD_ERROR_OF_MEAN|0.01039||0.8991|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8991
91648844|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002105|STANDARD_ERROR_OF_MEAN|0.002349||0.3711|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3711
91783681|NCT00202878|183447499|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.912||||0.016|TWO_SIDED|95.0|0.847|0.983|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.983|0.847|0.016
91783682|NCT00202878|183447500|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.945||||0.035|TWO_SIDED|95.0|0.897|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment|Model includes events from randomization to last study visit.|||0.996|0.897|0.035
91594661|NCT04416555|183079612|SUPERIORITY|||||||0.608|||||||Regression, Linear|||||||0.608
91783683|NCT01594528|183447509|OTHER|||||||0.992||||||comparison between groups for body indicators|Wilcoxon (Mann-Whitney)|||||||0.992
91783684|NCT01594528|183447509|OTHER|||||||0.8||||||comparison between groups facial indicators|Wilcoxon (Mann-Whitney)|||||||0.8
91783685|NCT01594528|183447509|OTHER|||||||0.586||||||comparison between groups for vocal indicators|Wilcoxon (Mann-Whitney)|||||||0.586
91783686|NCT00078897|183447590|OTHER|Negative binomial regression|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.91|1.16|||Negative binomial regression|||||1.16|0.91|0.68
91783687|NCT04421027|183447633|SUPERIORITY||Odds Ratio (OR)|0.85||||0.18|TWO_SIDED|95.0|0.67|1.08|||Regression, Logistic|||||1.08|0.67|0.1800
91783688|NCT04421027|183447634|SUPERIORITY||Odds Ratio (OR)|1.12||||0.728|TWO_SIDED|95.0|0.58|2.16|||Regression, Logistic|||||2.16|0.58|0.7280
91783689|NCT04421027|183447635|SUPERIORITY||Odds Ratio (OR)|1.07||||0.5444|TWO_SIDED|95.0|0.86|1.34|||Regression, Logistic|||||1.34|0.86|0.5444
91783690|NCT04421027|183447636|SUPERIORITY||LS Mean difference (net)|0.75|STANDARD_ERROR_OF_MEAN|0.399||0.0586|TWO_SIDED|95.0|0.0|1.5|||ANOVA|||||1.5|-0.0|0.0586
91594662|NCT04416555|183079613|SUPERIORITY|||||||0.768|||||||Mixed Models Analysis|||||||0.768
91594663|NCT04416555|183079614|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
91594664|NCT04416555|183079615|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
91783691|NCT04421027|183447637|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1453|TWO_SIDED|95.0|0.99|1.24|||Log Rank|||||1.24|0.99|0.1453
91783692|NCT04421027|183447638|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0464|TWO_SIDED|95.0|1.0|1.47|||Proportional Odds Model|||Day 4||1.47|1.00|0.0464
91783693|NCT04421027|183447639|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0172|TWO_SIDED|95.0|1.04|1.49|||Proportional Odds Model|||||1.49|1.04|0.0172
91783694|NCT04421027|183447640|SUPERIORITY||Odds Ratio (OR)|1.17||||0.0921|TWO_SIDED|95.0|0.97|1.41|||Proportional Odds Model|||||1.41|0.97|0.0921
91783695|NCT04421027|183447641|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0168|TWO_SIDED|95.0|1.05|1.56|||Proportional Odds Model|||||1.56|1.05|0.0168
91783696|NCT04421027|183447642|SUPERIORITY||LS Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.408||0.0626|TWO_SIDED|95.0|-1.6|0.0|||ANOVA|||||0.0|-1.6|0.0626
91783697|NCT04421027|183447643|SUPERIORITY||Odds Ratio (OR)|1.15||||0.429|TWO_SIDED|95.0|0.81|1.63|||Regression, Logistic|||||1.63|0.81|0.4290
91783698|NCT04421027|183447644|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0018|TWO_SIDED|95.0|0.41|0.78|||Log Rank|||||0.78|0.41|0.0018
91783699|NCT04421027|183447645|SUPERIORITY||LS Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.323||0.9526|TWO_SIDED|95.0|-0.62|0.65|||ANOVA|||||0.65|-0.62|0.9526
91783700|NCT04421027|183447646|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.1831|TWO_SIDED|95.0|0.741|1.061|||Log Rank|||||1.061|0.741|0.1831
91783701|NCT04421027|183447647|SUPERIORITY||Hazard Ratio (HR)|1.202||||0.0243|TWO_SIDED|95.0|1.017|1.421|||Log Rank|||||1.421|1.017|0.0243
91783702|NCT04421027|183447648|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.128||0.191|TWO_SIDED|95.0|-0.42|0.08|||Mixed Models Analysis|||Day 4||0.08|-0.42|0.191
91783703|NCT04421027|183447648|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.278|TWO_SIDED|95.0|-0.49|0.14|||Mixed Models Analysis|||Day 7||0.14|-0.49|0.278
91783704|NCT04421027|183447648|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.496|TWO_SIDED|95.0|-0.49|0.24|||Mixed Models Analysis|||Day 10||0.24|-0.49|0.496
91783705|NCT04421027|183447648|SUPERIORITY||LS Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.226||0.263|TWO_SIDED|95.0|-0.7|0.19|||Mixed Models Analysis|||Day 14||0.19|-0.70|0.263
91783706|NCT04421027|183447650|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6436|TWO_SIDED||||||Log Rank|||||||0.6436
91783707|NCT04421027|183447651|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.127|TWO_SIDED||||||Log Rank|||||||0.1270
91783708|NCT04421027|183447652|SUPERIORITY||LS Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3058|TWO_SIDED|95.0|-0.68|0.21|||ANOVA|||||0.21|-0.68|0.3058
91783709|NCT04421027|183447653|SUPERIORITY||LS Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.306||0.7073|TWO_SIDED|95.0|-0.49|0.72|||ANOVA|||||0.72|-0.49|0.7073
91783710|NCT05767749|183447692|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.93|TWO_SIDED|95.0|-12.8|14.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Lidocaine + epinephrine vs Bupivacaine)|||14.0|-12.8|0.93
91783711|NCT05767749|183447692|SUPERIORITY||Mean Difference (Final Values)|3.73||||0.54|TWO_SIDED|95.0|-8.3|15.8|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Ropivacaine vs Bupivacaine)|||15.8|-8.3|0.54
91783712|NCT05767749|183447692|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.6|TWO_SIDED|95.0|-8.7|15.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Bupivacaine) minus (Ropivacaine vs Bupivacaine)|||15.0|-8.7|0.60
91783713|NCT04838977|183447737|SUPERIORITY||Between group difference|-4.2|||||TWO_SIDED|95.0|-7.6|-0.8||||||The null hypothesis is there is no difference in mean CPSS at 10 weeks in the intervention group versus the control group.||-0.8|-7.6|
91783714|NCT00353470|183447747|SUPERIORITY||shared parameters model|-0.56|STANDARD_ERROR_OF_MEAN|0.29|>|0.16|TWO_SIDED||||||Chi-squared|||Power: to detect a between-group effect size of 0.45, for statistical power of 0.80, 56 patients for PFPP or CBT vs. 28 for ART were required. Response rates at termination were calculated by chi-square in the full ITT sample using LOCF.||||>0.16
91783715|NCT00353470|183447747|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91783716|NCT00950859|183447755|SUPERIORITY_OR_OTHER||percentage of participants|78.0|||||TWO_SIDED|95.0|58.0|91.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||91|58|
91783717|NCT00950859|183447755|SUPERIORITY_OR_OTHER||percentage of participants|96.0||||||95.0|79.0|100.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||100|79|
91783718|NCT03583385|183447773|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|103.42|||||TWO_SIDED|90.0|95.18|112.37||||||||112.37|95.18|
91783719|NCT03583385|183447774|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|106.78|||||TWO_SIDED|90.0|98.99|115.19||||||||115.19|98.99|
91783720|NCT04248491|183447854|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
91783721|NCT04248491|183447855|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91783722|NCT04248491|183447857|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
91783723|NCT04248491|183447859|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
91783724|NCT04248491|183447860|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||||||0.157
91783725|NCT04248491|183447861|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
91783726|NCT04248491|183447862|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
91783727|NCT04248491|183447863|SUPERIORITY|||||||0.799|||||||t-test, 2 sided|||||||0.799
91783728|NCT04248491|183447864|SUPERIORITY|||||||0.757|||||||t-test, 2 sided|||||||0.757
91783729|NCT04248491|183447865|SUPERIORITY|||||||0.472|||||||t-test, 2 sided|||||||0.472
91783730|NCT04248491|183447867|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
91790391|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.111||0.016|TWO_SIDED|95.0|0.051|0.486||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.486|0.051|0.016
91790392|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.33|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91594665|NCT00530270|183079621|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.127
91594666|NCT00530270|183079622|SUPERIORITY_OR_OTHER|||||||0.801||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.801
91594667|NCT00530270|183079623|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.02
91594668|NCT00530270|183079624|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.876
91594669|NCT00530270|183079625|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.770
91594670|NCT01118273|183079626|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
91594671|NCT01118273|183079627|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANCOVA|||||||0.31
91594672|NCT01118273|183079628|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||||||0.45
91594673|NCT01118273|183079629|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91594674|NCT01118273|183079630|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||||||0.05
91594675|NCT01118273|183079631|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|||||||0.019
91594676|NCT01118273|183079632|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.018
91648845|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001864|STANDARD_ERROR_OF_MEAN|0.002348||0.428|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4280
91594677|NCT01118273|183079633|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
91594678|NCT01118273|183079634|SUPERIORITY_OR_OTHER|||||||0.76|||||||Cochran-Mantel-Haenszel|||||||0.76
91594679|NCT01118273|183079635|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
91594680|NCT01118273|183079636|SUPERIORITY_OR_OTHER|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
91594681|NCT01118273|183079637|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
91594682|NCT01118273|183079638|SUPERIORITY_OR_OTHER|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
91594683|NCT01118273|183079640|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANCOVA|||||||0.42
91594684|NCT01118273|183079641|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
91594685|NCT01118273|183079642|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
91594686|NCT01118273|183079643|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANCOVA|||||||0.72
91594687|NCT01118273|183079644|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
91594688|NCT01118273|183079646|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.35
91594689|NCT01118273|183079648|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||||||0.53
91594690|NCT01118273|183079649|SUPERIORITY_OR_OTHER|||||||0.55|||||||ANCOVA|||||||0.55
91594691|NCT01118273|183079650|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANCOVA|||||||0.59
91594692|NCT01118273|183079651|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANCOVA|||||||0.25
91594693|NCT01197521|183079652|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
91594694|NCT01197521|183079652|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1||||0.006|TWO_SIDED|95.0|0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.03|0.006
91594695|NCT01197521|183079653|SUPERIORITY_OR_OTHER|||||||0.252||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.252
91648846|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00007|STANDARD_ERROR_OF_MEAN|0.003205||0.9831|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9831
91648847|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003052|STANDARD_ERROR_OF_MEAN|0.006364||0.632|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6320
91648848|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00007|STANDARD_ERROR_OF_MEAN|0.002259||0.9755|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9755
91648849|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00056|STANDARD_ERROR_OF_MEAN|0.001818||0.7584|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7584
91709237|NCT01402986|183311368|SUPERIORITY_OR_OTHER||Rate Ratio|1.39||||0.231|TWO_SIDED|95.0|0.81|2.38|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||2.38|0.81|0.231
91594696|NCT01197521|183079653|SUPERIORITY_OR_OTHER|||||||0.17||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.170
91594697|NCT01197521|183079654|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.13|||<|0.001|TWO_SIDED|95.0|0.1|0.17||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.10|<0.001
91594698|NCT01197521|183079655|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.16|||<|0.001|TWO_SIDED|95.0|0.11|0.22||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.11|<0.001
91594699|NCT01197521|183079655|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.002|TWO_SIDED|95.0|0.03|0.14||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.14|0.03|0.002
91594700|NCT01197521|183079656|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.12||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.05|<0.001
91594701|NCT01197521|183079656|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.04||||0.015|TWO_SIDED|95.0|0.01|0.07||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.01|0.015
91594702|NCT01197521|183079657|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
91594703|NCT01197521|183079657|SUPERIORITY_OR_OTHER|||||||0.002||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.002
91594704|NCT01197521|183079658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0|||<|0.001|TWO_SIDED|95.0|2.44|14.64||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.64|2.44|<0.001
91594705|NCT01197521|183079658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.76|11.02||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||11.02|1.76|0.002
91594706|NCT01197521|183079659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.63|5.67||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.67|1.63|<0.001
91594707|NCT01197521|183079659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.93|3.5||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.50|0.93|0.083
91594708|NCT01197521|183079660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.79|3.3||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.30|1.79|<0.001
91594709|NCT01197521|183079660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.004|TWO_SIDED|95.0|1.16|2.14||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.14|1.16|0.004
91790393|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.112||0.272|TWO_SIDED|95.0|-0.097|0.342||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.342|-0.097|0.272
91790394|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790395|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.145||0.671|TWO_SIDED|95.0|-0.223|0.347||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.347|-0.223|0.671
91594710|NCT01197521|183079661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.68|3.26||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.26|1.68|<0.001
91594711|NCT01197521|183079661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.38|2.68||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.68|1.38|<0.001
91594712|NCT01197521|183079662|SUPERIORITY_OR_OTHER||Treatment difference|2.24|||<|0.001||95.0|1.16|3.31||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.31|1.16|<0.001
91594713|NCT01197521|183079662|SUPERIORITY_OR_OTHER||Treatment difference|1.27||||0.02||95.0|0.2|2.35||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.35|0.20|0.020
91594714|NCT01197521|183079663|SUPERIORITY_OR_OTHER||Treatment difference|1.8||||0.005||95.0|0.54|3.07||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.07|0.54|0.005
91594715|NCT01197521|183079663|SUPERIORITY_OR_OTHER||Treatment difference|1.56||||0.017||95.0|0.28|2.83||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.28|0.017
91594716|NCT01309659|183079668|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the immediate intervention group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.308
91594717|NCT01309659|183079668|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.601
91594718|NCT01309659|183079668|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.396
91594719|NCT01309659|183079668|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.106
91594720|NCT01309659|183079668|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.606
91648850|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000297|STANDARD_ERROR_OF_MEAN|0.003444||0.9313|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9313
91594721|NCT01309659|183079668|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.077
91709238|NCT01402986|183311369|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.046|TWO_SIDED|95.0|0.06|0.98|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||0.98|0.06|0.046
91790396|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790397|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.143||0.493|TWO_SIDED|95.0|-0.183|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.378|-0.183|0.493
91790398|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91594722|NCT01309659|183079677|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the immediate intervention group. Testing the correlation =0.|t-test, 2 sided|||||||0.649
91594723|NCT01309659|183079677|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0.|t-test, 2 sided|||||||0.001
91594724|NCT01309659|183079678|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.391
91594725|NCT01309659|183079678|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0.|t-test, 2 sided|||||||0.111
91648851|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00129|STANDARD_ERROR_OF_MEAN|0.002097||0.5401|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5401
91594726|NCT01309659|183079679|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.077
91594727|NCT01309659|183079679|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.798
91594728|NCT01309659|183079679|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.383
91594729|NCT01309659|183079679|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.732
91594730|NCT01309659|183079679|SUPERIORITY_OR_OTHER|||||||0.286|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.286
91594731|NCT01309659|183079679|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.356
91594732|NCT01309659|183079680|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.649
91594733|NCT01309659|183079680|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.396
91594734|NCT01309659|183079681|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the intermediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.624
91594735|NCT01309659|183079681|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.329
91594736|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.48|||||TWO_SIDED|95.0|1.22|1.81|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 1||1.81|1.22|
91594737|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.31|||||TWO_SIDED|95.0|1.12|1.54|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 3||1.54|1.12|
91594738|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.13|1.58|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 4||1.58|1.13|
91594739|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.08|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 5||1.71|1.08|
91594740|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.37|||||TWO_SIDED|95.0|1.12|1.69|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6A||1.69|1.12|
91594741|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.17|1.7|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6B||1.70|1.17|
91594742|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.16|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 7F||1.55|1.16|
91648852|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00018|STANDARD_ERROR_OF_MEAN|0.002471||0.9421|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9421
91709239|NCT01402986|183311369|SUPERIORITY_OR_OTHER||Rate Ratio|0.47||||0.197|TWO_SIDED|95.0|0.15|1.48|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||1.48|0.15|0.197
91790399|NCT02880956|183460062|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.147||0.501|TWO_SIDED|95.0|-0.19|0.387||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.387|-0.190|0.501
91790400|NCT02880956|183460062|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790401|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.188||0.742|TWO_SIDED|95.0|-0.307|0.431||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.431|-0.307|0.742
91790402|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91594743|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 8||1.64|1.17|
91594744|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.24|||||TWO_SIDED|95.0|1.05|1.47|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 9V||1.47|1.05|
91594745|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 10A||1.44|1.03|
91594746|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.18|||||TWO_SIDED|95.0|0.98|1.42|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 11A||1.42|0.98|
91594747|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.99|1.46|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 12F||1.46|0.99|
91594748|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.21|1.67|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 14||1.67|1.21|
91594749|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.46|||||TWO_SIDED|95.0|1.22|1.76|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 15B||1.76|1.22|
91594750|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.29|||||TWO_SIDED|95.0|1.07|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 18C||1.55|1.07|
91594751|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19A||1.61|1.20|
91594752|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.33|||||TWO_SIDED|95.0|1.12|1.57|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19F||1.57|1.12|
91594753|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.12|1.6|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 22F||1.60|1.12|
91594754|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.09|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 23F||1.71|1.09|
91594755|NCT05879107|183079691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.2|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 33F||1.64|1.20|
91594756|NCT05879107|183079692|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer was \<=1.5.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-A||1.20|0.94|
91709240|NCT01402986|183311369|SUPERIORITY_OR_OTHER||Rate Ratio|1.18||||0.708|TWO_SIDED|95.0|0.5|2.79|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||2.79|0.50|0.708
91594757|NCT05879107|183079693|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer was \<=1.5.|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-B||1.13|0.89|
91594758|NCT02997735|183079707|SUPERIORITY||Odds Ratio (OR)|7.78|||<|0.001|TWO_SIDED|95.0|2.81|27.9|||Chi-squared||ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.|||27.90|2.81|<0.001
91594759|NCT02997735|183079708|SUPERIORITY||Odds Ratio (OR)|0.48||||0.15|TWO_SIDED|95.0|0.13|1.72|||Chi-squared||1-5 years Row (\<1 Ref)|||1.72|0.13|0.15
91594760|NCT02997735|183079708|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.18|2.12|||||6-12 years Row (\<1 Ref)|||2.12|0.18|
91594761|NCT02997735|183079708|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|0.49|6.94|||||13 or Older Row (\<1 Ref)|||6.94|0.49|
91594762|NCT02997735|183079709|SUPERIORITY||Odds Ratio (OR)|2.38||||0.028|TWO_SIDED|95.0|0.92|6.5|||Chi-squared||35-49 years Row (18-34 Ref)|||6.50|0.92|0.028
91594763|NCT02997735|183079709|SUPERIORITY||Odds Ratio (OR)|5.1|||||TWO_SIDED|95.0|1.46|17.32|||||50 or older Row (18-34 Ref)|||17.32|1.46|
91594764|NCT02997735|183079710|SUPERIORITY||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|2.8|||Chi-squared||Asthma Row (No asthma Ref)|||2.80|0.40|0.85
91783731|NCT01068964|183447869|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 1.5 mmHg was used. That is, if the upper limit of the 95% confidence interval for the difference in the mean diurnal IOP change between the two groups (Group 1 minus Group 2) is less than 1.5 mm Hg, then the null hypothesis will be rejected. The study had an 85% power.|Mean Difference (Final Values)|-0.556|||||TWO_SIDED|95.0|-1.68|0.57||||||A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.||0.57|-1.68|
91783732|NCT00621348|183447871|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|Risk Ratio (RR)|0.12|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|95.0|0.016|0.93||p value was adjusted for multiple comparisons.|Fisher Exact||The risk ratio is for Group A compared with Group C.|The incidence of hospital-acquired hyponatremia with current standard intravenous fluid therapy was approximately 30%. Sample of 72 patients would be needed in each group to demonstrate the decrease in incidence of hyponatremia (defined as plasma sodium\< 130 mEq/L) to 10%, with a power of 80 percent and alpha error of 0.05. In view of short study period and feasibility it was planned a priori to enroll at least 50 patients in each treatment limb.||0.93|0.016|<0.05
91783733|NCT02474069|183447876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.087|TWO_SIDED|95.0|0.39|1.07|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.07|0.39|0.087
91594765|NCT02997735|183079711|SUPERIORITY||Odds Ratio (OR)|2.07||||0.086|TWO_SIDED|95.0|0.9|6.5|||Chi-squared||10 or more cigarettes Row (\<10 cigarettes Ref)|||6.50|0.90|0.086
91594766|NCT02997735|183079712|SUPERIORITY||Odds Ratio (OR)|0.47||||0.35|TWO_SIDED|95.0|0.15|1.27|||Chi-squared||Less than 6 months Row (30 days Ref)|||1.27|0.15|0.35
91594767|NCT02997735|183079712|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.15|2.21|||||||6 or more months Row (30 days Ref)|2.21|0.15|
91594768|NCT03029143|183079719|OTHER||Odds Ratio (OR)|0.6|||=|0.401|TWO_SIDED|95.0|0.2|1.8|||Chi-squared||||Chi-squared test was used to estimate P-value from the logistic regression model where Endoscopic Mucosal Healing was the response variable and Treatment and TNF stratification were factors. Baseline complete Mayo Score and natural logarithm of trough concentration at week 6 were covariates.|1.8|0.2|=0.401
91594769|NCT03029143|183079720|OTHER||Adjusted risk difference|-0.4|||=|0.943|TWO_SIDED|95.0|-11.4|10.6|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|10.6|-11.4|=0.943
91594770|NCT03029143|183079721|OTHER||Adjusted risk difference|-1.2|||=|0.893|TWO_SIDED|95.0|-18.7|16.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|16.3|-18.7|=0.893
91594771|NCT03029143|183079722|OTHER||Adjusted risk difference|6.0|||=|0.525|TWO_SIDED|95.0|-12.4|24.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.3|-12.4|=0.525
91594772|NCT03029143|183079723|OTHER||Adjusted risk difference|-6.6|||=|0.623|TWO_SIDED|95.0|-34.0|20.8|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|20.8|-34.0|=0.623
91594773|NCT03029143|183079724|SUPERIORITY||Adjusted risk difference|8.1|||=|0.344|TWO_SIDED|95.0|-8.5|24.7|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.7|-8.5|=0.344
91594774|NCT04744207|183079727|SUPERIORITY||Least squares mean estimate|0.81|||<|0.05|TWO_SIDED|95.0|-2.48|4.1|||ANCOVA|||||4.10|-2.48|<0.05
91594775|NCT00258674|183079752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.307||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.307
91594776|NCT00258674|183079753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.551||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.551
91594777|NCT00258674|183079754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.927
91594778|NCT00258674|183079755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.308||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.308
91594779|NCT00258674|183079756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.867||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.867
91594780|NCT00258674|183079757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.807||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.807
91594781|NCT00258674|183079758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.702||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.702
91594782|NCT00258674|183079759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.413||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.413
91594783|NCT00258674|183079760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.996||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.996
91594784|NCT00258674|183079761|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.451||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.451
91594785|NCT00258674|183079762|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1||||0.447||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.447
91594786|NCT00258674|183079763|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.936||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.936
91594787|NCT00258674|183079764|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.332||95.0||||A comparison of the claims vs. claims+MR arms was also conducted, giving a p-value of 0.537.|Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.332
91783734|NCT02474069|183447877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.281|TWO_SIDED|95.0|0.43|1.28|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.28|0.43|0.281
91594788|NCT00258674|183079765|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.86||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.860
91594789|NCT00258674|183079766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.382||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.382
91594790|NCT00258674|183079767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.988||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.988
91594791|NCT00258674|183079768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.685
91594792|NCT03710486|183079834|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.13202|TWO_SIDED|95.0|0.32|1.16|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by propensity scores inverse probability treatment weighting (PS-IPTW).|Estimated with a logistic regression adjusted by PS-IPTW.|||1.16|0.32|=0.13202
91594793|NCT03710486|183079835|SUPERIORITY||Odds Ratio (OR)|1.18|||=|0.5861|TWO_SIDED|95.0|0.65|2.13|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.13|0.65|=0.5861
91594794|NCT03710486|183079838|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.1648|TWO_SIDED|95.0|0.35|1.19|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.19|0.35|=0.1648
91594795|NCT03710486|183079839|SUPERIORITY||Odds Ratio (OR)|0.66|||=|0.1732|TWO_SIDED|95.0|0.36|1.2|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.20|0.36|=0.1732
91594796|NCT03710486|183079842|SUPERIORITY||||||=|0.2011|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||CD: Vedolizumab Versus Other Biological||||=0.2011
91594797|NCT03710486|183079843|SUPERIORITY||||||=|0.6939|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||||||=0.6939
91594798|NCT03710486|183079844|SUPERIORITY||Odds Ratio (OR)|0.29|||=|0.0071|TWO_SIDED|95.0|0.12|0.71|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.71|0.12|=0.0071
91594799|NCT03710486|183079845|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.4809|TWO_SIDED|95.0|0.64|2.55|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.55|0.64|=0.4809
91594800|NCT03710486|183079846|SUPERIORITY||Odds Ratio (OR)|1.05|||=|0.915|TWO_SIDED|95.0|0.46|2.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.36|0.46|=0.9150
91594801|NCT03710486|183079847|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.7254|TWO_SIDED|95.0|0.56|2.28|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.28|0.56|=0.7254
91594802|NCT03710486|183079848|SUPERIORITY||Odds Ratio (OR)|0.34|||=|0.0051|TWO_SIDED|95.0|0.16|0.72|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.72|0.16|=0.0051
91594803|NCT03710486|183079849|SUPERIORITY||Odds Ratio (OR)|0.53|||=|0.0653|TWO_SIDED|95.0|0.27|1.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.04|0.27|=0.0653
91594804|NCT03710486|183079850|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.7629|TWO_SIDED|95.0|0.47|1.74|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.74|0.47|=0.7629
91594805|NCT03710486|183079851|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.4895|TWO_SIDED|95.0|0.43|1.5|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.50|0.43|=0.4895
91594806|NCT03710486|183079852|SUPERIORITY||Odds Ratio (OR)|0.76|||=|0.4458|TWO_SIDED|95.0|0.38|1.54|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.54|0.38|=0.4458
91594807|NCT03710486|183079853|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.04|0.47|=0.9471
91594808|NCT03710486|183079854|SUPERIORITY||Odds Ratio (OR)|0.42|||=|0.0104|TWO_SIDED|95.0|0.21|0.81|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.81|0.21|=0.0104
91594809|NCT03710486|183079855|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
91594810|NCT03710486|183079856|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|CD Participants||2.04|0.47|=0.9471
91594811|NCT03710486|183079857|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.0104|TWO_SIDED|95.0|0.12|0.75|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.75|0.12|=0.0104
91594812|NCT03710486|183079858|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
91594813|NCT03710486|183079859|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.54|TWO_SIDED|95.0|0.59|2.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.78|0.59|=0.5400
91594814|NCT03710486|183079860|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.8123|TWO_SIDED|95.0|0.26|5.66|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||5.66|0.26|=0.8123
91594815|NCT03710486|183079861|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.0282|TWO_SIDED|95.0|0.06|0.85|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.85|0.06|=0.0282
91594816|NCT03710486|183079862|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.8584|TWO_SIDED|95.0|0.29|4.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||4.36|0.29|=0.8584
91594817|NCT03710486|183079863|SUPERIORITY||Odds Ratio (OR)|0.95|||=|0.9474|TWO_SIDED|95.0|0.24|3.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||3.78|0.24|=0.9474
91594818|NCT03710486|183079864|SUPERIORITY||Odds Ratio (OR)|0.73|||=|0.3103|TWO_SIDED|95.0|0.4|1.34|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.34|0.40|=0.3103
91594819|NCT03710486|183079864|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0045|TWO_SIDED|95.0|0.22|0.76|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||0.76|0.22|=0.0045
91594820|NCT03710486|183079864|SUPERIORITY||Odds Ratio (OR)|1.19|||=|0.6287|TWO_SIDED|95.0|0.59|2.42|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.42|0.59|=0.6287
91594821|NCT03710486|183079864|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.2495|TWO_SIDED|95.0|0.31|1.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||1.36|0.31|=0.2495
91594822|NCT03710486|183079865|SUPERIORITY||Risk Ratio (RR)|0.89|||=|0.4784|TWO_SIDED|95.0|0.66|1.22|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.22|0.66|=0.4784
91594823|NCT03710486|183079865|SUPERIORITY||Risk Ratio (RR)|0.83|||=|0.2616|TWO_SIDED|95.0|0.6|1.15|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.15|0.60|=0.2616
91594824|NCT03710486|183079865|SUPERIORITY||Risk Ratio (RR)|2.01|||=|0.0077|TWO_SIDED|95.0|1.2|3.34|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||3.34|1.20|=0.0077
91594825|NCT03710486|183079865|SUPERIORITY||Risk Ratio (RR)|1.3|||=|0.3046|TWO_SIDED|95.0|0.79|2.14|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.14|0.79|=0.3046
91594826|NCT03710486|183079866|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.1681|TWO_SIDED|95.0|0.22|1.3|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.30|0.22|=0.1681
91594827|NCT03710486|183079866|SUPERIORITY||Odds Ratio (OR)|0.23|||=|0.0645|TWO_SIDED|95.0|0.05|1.09|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.09|0.05|=0.0645
91594828|NCT03710486|183079866|SUPERIORITY||Odds Ratio (OR)|0.38|||=|0.3145|TWO_SIDED|95.0|0.06|2.51|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.51|0.06|=0.3145
91594829|NCT03710486|183079866|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.8197|TWO_SIDED|95.0|0.05|47.11|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||47.11|0.05|=0.8197
91594830|NCT03710486|183079867|SUPERIORITY||Risk Ratio (RR)|0.43|||=|0.0239|TWO_SIDED|95.0|0.2|0.89|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.89|0.20|=0.0239
91594831|NCT03710486|183079867|SUPERIORITY||Risk Ratio (RR)|0.21|||=|0.0373|TWO_SIDED|95.0|0.05|0.91|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.91|0.05|=0.0373
91594832|NCT03710486|183079867|SUPERIORITY||Risk Ratio (RR)|0.54|||=|0.426|TWO_SIDED|95.0|0.12|2.49|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.49|0.12|=0.4260
91594833|NCT03710486|183079867|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression||The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||48.44|0.05|=0.8012
91594834|NCT03710486|183079868|SUPERIORITY||Odds Ratio (OR)|0.17|||=|0.0044|TWO_SIDED|95.0|0.05|0.58|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.58|0.05|=0.0044
91594835|NCT03710486|183079868|SUPERIORITY||Odds Ratio (OR)|0.32|||=|0.0215|TWO_SIDED|95.0|0.12|0.84|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.84|0.12|=0.0215
91594836|NCT03710486|183079869|SUPERIORITY||Risk Ratio (RR)|0.27|||=|0.0152|TWO_SIDED|95.0|0.1|0.78|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.78|0.10|=0.0152
91594837|NCT03710486|183079869|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||48.44|0.05|=0.8012
91594838|NCT01147744|183079885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.326|TWO_SIDED|95.0|-0.06|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.06|0.326
91594839|NCT01147744|183079885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.104||||0.066|TWO_SIDED|95.0|-0.01|0.22||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.22|-0.01|0.066
91594840|NCT01147744|183079885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.224|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.224
91594841|NCT01147744|183079885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.062||||0.271|TWO_SIDED|95.0|-0.05|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.05|0.271
91594842|NCT01147744|183079885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.189|||<|0.001|TWO_SIDED|95.0|0.08|0.3||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.30|0.08|<0.001
91594843|NCT01147744|183079885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.22|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.220
91594844|NCT01147744|183079886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.932|TWO_SIDED|95.0|-9.25|8.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||8.48|-9.25|0.932
91594845|NCT01147744|183079886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.367||||0.762|TWO_SIDED|95.0|-7.5|10.23|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.23|-7.50|0.762
91594846|NCT01147744|183079886|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.798||||0.689|TWO_SIDED|95.0|-10.62|7.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||7.03|-10.62|0.689
91594847|NCT01147744|183079886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.321||||0.605|TWO_SIDED|95.0|-6.49|11.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.13|-6.49|0.605
91594848|NCT01147744|183079886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.584|TWO_SIDED|95.0|-6.36|11.28|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.28|-6.36|0.584
91594849|NCT01147744|183079886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.529||||0.907|TWO_SIDED|95.0|-8.4|9.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||9.45|-8.40|0.907
91594850|NCT01147744|183079887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.463||||0.753|TWO_SIDED|95.0|-7.65|10.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.58|-7.65|0.753
91594851|NCT01147744|183079887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.419|TWO_SIDED|95.0|-5.36|12.87|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.87|-5.36|0.419
91594852|NCT01147744|183079887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.046||||0.51|TWO_SIDED|95.0|-12.12|6.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||6.03|-12.12|0.510
91594853|NCT01147744|183079887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.585||||0.32|TWO_SIDED|95.0|-4.47|13.64|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||13.64|-4.47|0.320
91594854|NCT01147744|183079887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.484||||0.452|TWO_SIDED|95.0|-5.61|12.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.58|-5.61|0.452
91594855|NCT01147744|183079887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.615||||0.229|TWO_SIDED|95.0|-3.55|14.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||14.78|-3.55|0.229
91594856|NCT01147744|183079888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.169||||0.771|TWO_SIDED|95.0|-6.73|9.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.07|-6.73|0.771
91594857|NCT01147744|183079888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56||||0.257|TWO_SIDED|95.0|-3.33|12.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.45|-3.33|0.257
91594858|NCT01147744|183079888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.326||||0.741|TWO_SIDED|95.0|-6.54|9.19|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.19|-6.54|0.741
91594859|NCT01147744|183079888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.983|TWO_SIDED|95.0|-7.76|7.93|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.93|-7.76|0.983
91594860|NCT01147744|183079888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.204||||0.041|TWO_SIDED|95.0|0.34|16.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||16.07|0.34|0.041
91594861|NCT01147744|183079888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.891||||0.475|TWO_SIDED|95.0|-5.05|10.83|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.83|-5.05|0.475
91709241|NCT01402986|183311369|SUPERIORITY_OR_OTHER||Rate Ratio|1.31||||0.594|TWO_SIDED|95.0|0.48|3.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||3.57|0.48|0.594
91594862|NCT01147744|183079889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.837||||0.838|TWO_SIDED|95.0|-7.22|8.89|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.89|-7.22|0.838
91594863|NCT01147744|183079889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.715||||0.508|TWO_SIDED|95.0|-5.33|10.76|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.76|-5.33|0.508
91594864|NCT01147744|183079889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.124||||0.603|TWO_SIDED|95.0|-5.9|10.14|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.14|-5.90|0.603
91594865|NCT01147744|183079889|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.781||||0.662|TWO_SIDED|95.0|-9.78|6.22|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||6.22|-9.78|0.662
91594866|NCT01147744|183079889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.949||||0.146|TWO_SIDED|95.0|-2.08|13.98|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.98|-2.08|0.146
91594867|NCT01147744|183079889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.394||||0.191|TWO_SIDED|95.0|-2.69|13.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.48|-2.69|0.191
91594868|NCT01147744|183079890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.106||||0.164|TWO_SIDED|95.0|-2.5|14.71|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||14.71|-2.50|0.164
91594869|NCT01147744|183079890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.106||||0.349||95.0|-4.49|12.7|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.70|-4.49|0.349
91594870|NCT01147744|183079890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.148||||0.623|TWO_SIDED|95.0|-6.42|10.72|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.72|-6.42|0.623
91594871|NCT01147744|183079890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.713||||0.694|TWO_SIDED|95.0|-6.84|10.26|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.26|-6.84|0.694
91594872|NCT01147744|183079890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.592||||0.028|TWO_SIDED|95.0|1.03|18.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||18.15|1.03|0.028
91709242|NCT01402986|183311370|SUPERIORITY_OR_OTHER||Rate Ratio|1.03||||0.975|TWO_SIDED|95.0|0.14|7.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||7.67|0.14|0.975
91594873|NCT01147744|183079890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.75||||0.125|TWO_SIDED|95.0|-1.89|15.38|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.38|-1.89|0.125
91594874|NCT01147744|183079891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.346||||0.585|TWO_SIDED|95.0|-6.09|10.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.78|-6.09|0.585
91594875|NCT01147744|183079891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.431||||0.92|TWO_SIDED|95.0|-8.0|8.86|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.86|-8.00|0.920
91594876|NCT01147744|183079891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.702||||0.528|TWO_SIDED|95.0|-5.7|11.11|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||11.11|-5.70|0.528
91594877|NCT01147744|183079891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.218||||0.776|TWO_SIDED|95.0|-9.6|7.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.17|-9.60|0.776
91594878|NCT01147744|183079891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.49||||0.081|TWO_SIDED|95.0|-0.92|15.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.90|-0.92|0.081
91594879|NCT01147744|183079891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.611||||0.403|TWO_SIDED|95.0|-4.87|12.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.09|-4.87|0.403
91594880|NCT01147744|183079892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005||||0.951|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.17|0.951
91594881|NCT01147744|183079892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.043|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.01|-0.33|0.043
91783735|NCT00918736|183447891|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be \> 1 using pair t-test after 3 weekly injections, investigators need \> 42 patients to give \> 90% power to reject the null hypothesis-mean AOS score reduction \<1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients||||<0.05
91783736|NCT01474018|183447898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
91783737|NCT01474018|183447899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91594882|NCT01147744|183079892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.734|TWO_SIDED|95.0|-0.19|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.19|0.734
91594883|NCT01147744|183079892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003||||0.972|TWO_SIDED|95.0|-0.16|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.16|0.972
91594884|NCT01147744|183079892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.097||||0.238|TWO_SIDED|95.0|-0.26|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.26|0.238
91594885|NCT01147744|183079892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075||||0.36|TWO_SIDED|95.0|-0.24|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.24|0.360
91594886|NCT01147744|183079893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.692|TWO_SIDED|95.0|-0.11|0.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.17|-0.11|0.692
91594887|NCT01147744|183079893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.176|TWO_SIDED|95.0|-0.24|0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.04|-0.24|0.176
91594888|NCT01147744|183079893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021||||0.768|TWO_SIDED|95.0|-0.16|0.12|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.12|-0.16|0.768
91594889|NCT01147744|183079893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.887|TWO_SIDED|95.0|-0.13|0.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.15|-0.13|0.887
91594890|NCT01147744|183079893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051||||0.471|TWO_SIDED|95.0|-0.19|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.19|0.471
91594891|NCT01147744|183079893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083||||0.248|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.22|0.248
91594892|NCT01147744|183079894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131||||0.209|TWO_SIDED|95.0|-0.33|0.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.07|-0.33|0.209
91783738|NCT01474018|183447899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
91783739|NCT00838513|183447936|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
91783740|NCT00838513|183447937|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
91594893|NCT01147744|183079894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.264||||0.011|TWO_SIDED|95.0|-0.47|-0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.06|-0.47|0.011
91594894|NCT01147744|183079894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076||||0.464|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.28|0.464
91594895|NCT01147744|183079894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.662|TWO_SIDED|95.0|-0.25|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.25|0.662
91594896|NCT01147744|183079894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.018|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.04|-0.45|0.018
91594897|NCT01147744|183079894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.207||||0.047|TWO_SIDED|95.0|-0.41|0.0|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.00|-0.41|0.047
91594898|NCT01147744|183079895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.3|TWO_SIDED|95.0|-0.28|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.28|0.300
91594899|NCT01147744|183079895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.138||||0.145|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.05|-0.32|0.145
91594900|NCT01147744|183079895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.123||||0.19|TWO_SIDED|95.0|-0.31|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.31|0.190
91594901|NCT01147744|183079895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.98|TWO_SIDED|95.0|-0.19|0.18|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.18|-0.19|0.980
91648853|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00151|STANDARD_ERROR_OF_MEAN|0.003983||0.7042|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7042
91594902|NCT01147744|183079895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.171||||0.07|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.01|-0.36|0.070
91594903|NCT01147744|183079895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.158||||0.095|TWO_SIDED|95.0|-0.34|0.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.03|-0.34|0.095
91594904|NCT01147744|183079896|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91594905|NCT01147744|183079896|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
91594906|NCT01147744|183079896|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91594907|NCT01147744|183079896|SUPERIORITY_OR_OTHER|||||||0.828|||||||Fisher Exact|||||||0.828
91594908|NCT01147744|183079896|SUPERIORITY_OR_OTHER|||||||0.477|||||||Fisher Exact|||||||0.477
91594909|NCT01147744|183079896|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.460
91594910|NCT01342484|183079903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.48||0.3295|TWO_SIDED|95.0|-1.47|0.51|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, pharmacokinetic (PK) / pharmacodynamics (PD) subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.51|-1.47|0.3295
91594911|NCT01342484|183079903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.42||0.1447|TWO_SIDED|95.0|-1.5|0.23|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.23|-1.50|0.1447
91594912|NCT01342484|183079905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|1.36||0.8216|TWO_SIDED|95.0|-3.08|2.46|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||2.46|-3.08|0.8216
91613983|NCT00431847|183121845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.108|STANDARD_ERROR_OF_MEAN|0.2308||0.64|TWO_SIDED|95.0|-0.5621|0.3461|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.|Estimated intercept group difference|A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3461|-0.5621|0.640
91648854|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.02128|STANDARD_ERROR_OF_MEAN|0.008331||0.0114|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0114
91594913|NCT01342484|183079905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.18||0.1189|TWO_SIDED|95.0|-4.31|0.52|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.52|-4.31|0.1189
91594914|NCT00432042|183079906|NON_INFERIORITY_OR_EQUIVALENCE|Measles difference|Mean Difference (Final Values)|1.14|||||TWO_SIDED|95.0|-1.62|4.82|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||4.82|-1.62|
91594915|NCT00432042|183079906|NON_INFERIORITY_OR_EQUIVALENCE|Mumps difference|Mean Difference (Final Values)|-1.83|||||TWO_SIDED|95.0|-4.21|1.1|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.10|-4.21|
91594916|NCT00432042|183079906|NON_INFERIORITY_OR_EQUIVALENCE|Rubella difference|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.19|1.35|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.35|-3.19|
91594917|NCT00432042|183079906|NON_INFERIORITY_OR_EQUIVALENCE|Varicella difference|Mean Difference (Final Values)|2.53|||||TWO_SIDED|95.0|-0.41|6.58|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||6.58|-0.41|
91594918|NCT00432042|183079907|NON_INFERIORITY_OR_EQUIVALENCE|Hepatitis B difference|Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.29|4.24|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||4.24|-0.29|
91594919|NCT00432042|183079907|NON_INFERIORITY_OR_EQUIVALENCE|Haemophilus Influenza type B difference|Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-0.17|6.89|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||6.89|-0.17|
91594920|NCT00432042|183079908|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PT difference|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.08|0.88|
91648855|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002587|STANDARD_ERROR_OF_MEAN|0.001727||0.1358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1358
91783741|NCT00838513|183447938|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
91783742|NCT00838513|183447939|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
91594921|NCT00432042|183079908|NON_INFERIORITY_OR_EQUIVALENCE|Anti-FHA difference|GMT ratio|1.09|||||TWO_SIDED|95.0|0.98|1.23|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.23|0.98|
91594922|NCT00432042|183079908|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PRN difference|GMT ratio|1.18|||||TWO_SIDED|95.0|1.03|1.36|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.36|1.03|
91594923|NCT00492752|183079951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6783||||0.014144||95.0|0.4962|0.9272|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||0.9272|0.4962|0.014144
91594924|NCT00492752|183079951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6208||||0.003464||95.0|0.4498|0.8568|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.8568|0.4498|0.003464
91594925|NCT00492752|183079952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9032||||0.497537||95.0|0.6705|1.2165|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||1.2165|0.6705|0.497537
91594926|NCT00492752|183079952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8831||||0.437926||95.0|0.6449|1.2093|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||1.2093|0.6449|0.437926
91594927|NCT00492752|183079953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5744||||0.000537||95.0|0.4154|0.7942|||Log Rank||Hazard ratio is for Sorafenib vs placebo|||0.7942|0.4154|0.000537
91594928|NCT00492752|183079953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5375||||0.00054||95.0|0.3763|0.7677|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.7677|0.3763|0.000540
91594929|NCT00492752|183079954|SUPERIORITY_OR_OTHER||Disease control rate|0.3533||||||95.0|0.2771|0.4355||||||||0.4355|0.2771|
91594930|NCT00492752|183079954|SUPERIORITY_OR_OTHER||Disease control rate|0.1579||||||95.0|0.0843|0.2596||||||||0.2596|0.0843|
91594931|NCT00492752|183079957|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|based on tumor response rate (CR+PR)||||||0.67
91594932|NCT04649255|183079991|OTHER||Exact binomial|96.4|||<|0.025|TWO_SIDED|95.0|96.4|100.0|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: Ps ≤ PGS, versus HA: PS \> PGS, where where Ps is the population primary safety success rate in the Test group and PGS is the safety performance goal of 82%.||100|96.4|<0.025
91594933|NCT04649255|183079992|OTHER||Exact binomial|89.1|||<|0.025|TWO_SIDED|95.0|89.1|97.5|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: PE ≤ PGE, versus HA: PE \> PGE, where PE is the proportion of target lesions with clinical success and PGE is the effectiveness performance goal of 72%.||97.5|89.1|<0.025
91594934|NCT03357731|183080060|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|0.9242||0.027|TWO_SIDED|95.0|-4.0432|-0.257|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.2570|-4.0432|0.027
91594935|NCT03357731|183080061|SUPERIORITY||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.9832||0.846|TWO_SIDED|95.0|-1.8176|2.2042|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||2.2042|-1.8176|0.846
91594936|NCT03357731|183080062|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.93||0.177|TWO_SIDED|95.0|-0.62|3.19|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||3.19|-0.62|0.177
91594937|NCT03357731|183080062|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.839|TWO_SIDED|95.0|-1.08|0.88|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.88|-1.08|0.839
91594938|NCT03357731|183080063|SUPERIORITY||Mean Difference (Net)|-0.0977|STANDARD_ERROR_OF_MEAN|0.03308||0.007|TWO_SIDED|95.0|-0.16634|-0.02915|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.02915|-0.16634|0.007
91594939|NCT03357731|183080063|SUPERIORITY||Mean Difference (Net)|-0.0371|STANDARD_ERROR_OF_MEAN|0.02194||0.103|TWO_SIDED|95.0|-0.08243|0.00814|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.00814|-0.08243|0.103
91594940|NCT03357731|183080064|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.037||0.003|TWO_SIDED|95.0|-0.205|-0.051|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||-0.051|-0.205|0.003
91594941|NCT03357731|183080064|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.904|TWO_SIDED|95.0|-0.051|0.057|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||0.057|-0.051|0.904
91594942|NCT03357731|183080064|SUPERIORITY||Mean Difference (Net)|-1.66|STANDARD_ERROR_OF_MEAN|0.527||0.006|TWO_SIDED|95.0|-2.763|-0.549|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||-0.549|-2.763|0.006
91594943|NCT03357731|183080064|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.392||0.503|TWO_SIDED|95.0|-1.085|0.55|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||0.550|-1.085|0.503
91594944|NCT03357731|183080065|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.398||0.994|TWO_SIDED|95.0|-0.827|0.82|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||0.820|-0.827|0.994
91594945|NCT03357731|183080065|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.258||0.073|TWO_SIDED|95.0|-0.049|1.013|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||1.013|-0.049|0.073
91594946|NCT03357731|183080066|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.4||0.705|TWO_SIDED|95.0|-0.67|0.976|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.976|-0.670|0.705
91648856|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001402|STANDARD_ERROR_OF_MEAN|0.001796||0.4354|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4354
91648857|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.005759|STANDARD_ERROR_OF_MEAN|0.002113||0.007|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0070
91790403|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.185||0.431|TWO_SIDED|95.0|-0.511|0.218||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.218|-0.511|0.431
91783743|NCT00838513|183447940|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
91783744|NCT00838513|183447941|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
91594947|NCT03357731|183080066|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.404||0.105|TWO_SIDED|95.0|-1.504|0.151|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.151|-1.504|0.105
91594948|NCT02347098|183080092|SUPERIORITY|||||||0.2533|||||||t-test, 2 sided|||||||0.2533
91594949|NCT02347098|183080093|SUPERIORITY|||||||0.779|||||||t-test, 2 sided|||||||0.7790
91594950|NCT02347098|183080094|SUPERIORITY|||||||0.4549||||||The p-value reported compares the trends of outcome across time (baseline pre-PCI, baseline post-PCI, 30-day follow-up, and 90-day follow-up) between treatment groups using the repeated measurement analysis.|Mixed Models Analysis|||||||0.4549
91594951|NCT02347098|183080095|SUPERIORITY|||||||0.2663|||||||Fisher Exact|||||||0.2663
91594952|NCT04673292|183080099|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing community-based testing to the fixed site SOC testing.|Prevalence Ratio|1.04||||0.67|TWO_SIDED|95.0|0.86|1.27|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.27|0.86|0.67
91594953|NCT04673292|183080099|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing self-collected testing to the fixed site SOC testing.|Prevalence Ratio|1.08||||0.43|TWO_SIDED|95.0|0.89|1.31|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.31|0.89|0.43
91594954|NCT04673292|183080100|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the community-based testing to fixed site SOC testing. Alpha threshold of 0.05.|Time Ratio|0.87||||0.14|TWO_SIDED|95.0|0.73|1.05||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.05|0.73|0.14
91594955|NCT04673292|183080100|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05.|Time Ratio|0.86||||0.09|TWO_SIDED|95.0|0.71|1.03||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.03|0.71|0.09
91594956|NCT04673292|183080101|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the community-based testing to fixed site SOC testing.|Time Ratio|0.96||||0.56|TWO_SIDED|95.0|0.83|1.1||aprior threshold for significance: p\<0.05|Accelerated Failure Time|Study arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.10|0.83|0.56
91594957|NCT04673292|183080101|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing.|Time Ratio|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.07|0.81|0.32
91594958|NCT02535715|183080106|SUPERIORITY|ANOVA Bonferroni adjustment|||||<|0.05|||||||ANOVA|||||||<0.05
91594959|NCT04353284|183080107|SUPERIORITY||Mean Difference (Net)|0.74||||0.06|TWO_SIDED|95.0|-0.03|1.51|||Mixed Models Analysis|||This analysis compares the change from baseline between treatment arms.||1.51|-0.03|0.06
91594960|NCT04353284|183080108|SUPERIORITY||Mean Difference (Net)|0.06||||0.87|TWO_SIDED|95.0|-0.7|0.83|||Mixed Models Analysis|||||0.83|-0.70|0.87
91594961|NCT04353284|183080109|SUPERIORITY||Mean Difference (Net)|0.23||||0.69|TWO_SIDED|95.0|-0.94|1.4|||Mixed Models Analysis|||||1.4|-0.94|0.69
91594962|NCT04353284|183080110|SUPERIORITY||Odds Ratio (OR)|1.3||||0.71|TWO_SIDED|95.0|0.33|5.09|||GEE|||Nasopharyngeal Swab Samples analyzed.||5.09|0.33|0.71
91594963|NCT04353284|183080110|SUPERIORITY||Odds Ratio (OR)|0.4||||0.17|TWO_SIDED|95.0|0.11|1.47|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||1.47|0.11|0.17
91594964|NCT04353284|183080111|SUPERIORITY||Odds Ratio (OR)|3.05||||0.03|TWO_SIDED|95.0|1.12|8.26|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||8.26|1.12|0.03
91783745|NCT00838513|183447942|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
91594965|NCT04353284|183080111|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.47|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.47|0.68
91594966|NCT04353284|183080112|SUPERIORITY||Odds Ratio (OR)|6.28||||0.1|TWO_SIDED|95.0|0.7|56.6|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||56.60|0.70|0.10
91594967|NCT04353284|183080112|SUPERIORITY||Odds Ratio (OR)|0.9||||0.87|TWO_SIDED|95.0|0.25|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.25|0.87
91594968|NCT04353284|183080113|SUPERIORITY||Mean Difference (Net)|-6.6||||0.02|TWO_SIDED|95.0|-12.1|-1.2|||Mixed Models Analysis|||||-1.2|-12.1|0.02
91594969|NCT04353284|183080114|SUPERIORITY||Mean Difference (Net)|-2.1||||0.48|TWO_SIDED|95.0|-7.9|3.7|||Mixed Models Analysis|||||3.7|-7.9|0.48
91594970|NCT04353284|183080115|SUPERIORITY||Mean Difference (Net)|1.0||||0.16|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||||2.3|-0.4|0.16
91594971|NCT04353284|183080116|SUPERIORITY||Mean Difference (Net)|0.7||||0.34|TWO_SIDED|95.0|-0.7|2.1|||Mixed Models Analysis|||||2.1|-0.7|0.34
91783746|NCT00838513|183447943|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
91594972|NCT03448068|183080119|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91594973|NCT03448068|183080120|SUPERIORITY|||||||0.2252|||||||t-test, 2 sided|||||||0.2252
91594974|NCT03448068|183080121|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.0610
91594975|NCT03448068|183080122|SUPERIORITY|||||||0.272|||||||t-test, 2 sided|||||||0.2720
91594976|NCT03448068|183080123|SUPERIORITY|||||||0.7298|||||||Chi-squared|||Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapy||||0.7298
91594977|NCT03448068|183080123|SUPERIORITY|||||||0.1058|||||||Chi-squared|||Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapy||||0.1058
91594978|NCT03448068|183080123|SUPERIORITY|||||||1|||||||Chi-squared|||Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapy||||1.000
91594979|NCT03448068|183080124|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
91594980|NCT01438489|183080128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.014|TWO_SIDED|90.0|1.33|4.26|||Regression, Logistic|||All-comers||4.26|1.33|0.014
91594981|NCT01438489|183080128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.063|TWO_SIDED|90.0|1.08|3.49|||Regression, Logistic|||All-comers||3.49|1.08|0.063
91594982|NCT01438489|183080129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55||||0.004|TWO_SIDED|90.0|1.72|7.32|||Regression, Logistic|||High||7.32|1.72|0.004
91594983|NCT01438489|183080129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.029|TWO_SIDED|90.0|1.27|5.53|||Regression, Logistic|||High||5.53|1.27|0.029
91594984|NCT03129321|183080161|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|4.24|||||TWO_SIDED|90.0|-5.05|13.54||||||||13.54|-5.05|
91594985|NCT03129321|183080162|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91594986|NCT03129321|183080162|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
91594987|NCT03129321|183080163|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|2.85|||||TWO_SIDED|90.0|-6.29|11.98||||||||11.98|-6.29|
91594988|NCT03129321|183080164|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|-0.02|||||TWO_SIDED|90.0|-8.29|8.26||||||||8.26|-8.29|
91594989|NCT03129321|183080165|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.0020
91594990|NCT03129321|183080165|SUPERIORITY|||||||0.0076|||||||Cochran-Mantel-Haenszel|||||||0.0076
91594991|NCT03129321|183080166|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91594992|NCT03129321|183080166|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91594993|NCT03070470|183080167|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|90.0|-9.5|12.0||The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.|Mixed Models Analysis|||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||12.0|-9.5|
91709243|NCT01402986|183311370|SUPERIORITY_OR_OTHER||Rate Ratio|1.66||||0.473|TWO_SIDED|95.0|0.41|6.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||6.67|0.41|0.473
91783747|NCT00838513|183447944|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
91783748|NCT00838513|183447945|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
91783749|NCT00838513|183447946|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
91783750|NCT00838513|183447947|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
91594994|NCT03070470|183080167|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.6|||||TWO_SIDED|90.0|-11.4|6.1|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||6.1|-11.4|
91648858|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01037|STANDARD_ERROR_OF_MEAN|0.004485||0.0217|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0217
91594995|NCT03070470|183080167|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.9|||||TWO_SIDED|90.0|-14.6|8.8|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||8.8|-14.6|
91594996|NCT03070470|183080168|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|30.7|||||TWO_SIDED|90.0|22.6|38.9|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model.||38.9|22.6|
91594997|NCT02375724|183080177|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.02||||0.0306|TWO_SIDED|95.0|-1.94|-0.1|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||-0.10|-1.94|0.0306
91594998|NCT02375724|183080178|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22||||0.0793|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.03|-0.46|0.0793
91594999|NCT02375724|183080179|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.06||||0.844|TWO_SIDED|95.0|-0.64|0.52|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.52|-0.64|0.844
91595000|NCT02285998|183080225|NON_INFERIORITY_OR_EQUIVALENCE|The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.|Relative Vaccine Efficacy (rVE)|30.0|||||TWO_SIDED|95.0|10.0|47.0||||||The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was \> -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be \> +9%.||47|10|
91595001|NCT04041284|183080248|OTHER||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.16|-1.21|||ANCOVA|||||-1.21|-3.16|<0.0001
91595002|NCT04041284|183080249|OTHER||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0205|TWO_SIDED|95.0|-2.61|-0.22|||Mixed Models Analysis|||||-0.22|-2.61|0.0205
91595003|NCT04041284|183080250|OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.89|5.62|||Regression, Logistic|||||5.62|1.89|<0.0001
91595004|NCT04041284|183080251|OTHER||LS mean difference|11.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.0001|TWO_SIDED|95.0|6.91|15.59|||Mixed Models Analysis||Restrictive score: Fremanezumab versus placebo|||15.59|6.91|<0.0001
91595005|NCT04041284|183080251|OTHER||LS mean difference|9.9|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|5.73|14.08|||Mixed Models Analysis||Preventive score: Fremanezumab versus placebo|||14.08|5.73|<0.0001
91595006|NCT04041284|183080252|OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0915|TWO_SIDED|95.0|-0.39|0.03|||Mixed Models Analysis||Change at Week 4: Fremanezumab versus Placebo|||0.03|-0.39|0.0915
91709244|NCT01402986|183311370|SUPERIORITY_OR_OTHER||Rate Ratio|0.49||||0.099|TWO_SIDED|95.0|0.21|1.14|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.14|0.21|0.099
91709245|NCT01402986|183311370|SUPERIORITY_OR_OTHER||Rate Ratio|0.42||||0.148|TWO_SIDED|95.0|0.13|1.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.36|0.13|0.148
91595007|NCT04041284|183080252|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0006|TWO_SIDED|95.0|-0.59|-0.16|||Mixed Models Analysis||Change at Week 8: Fremanezumab versus Placebo|||-0.16|-0.59|0.0006
91595008|NCT04041284|183080252|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.58|-0.12|||Mixed Models Analysis||Change at Week 12: Fremanezumab versus Placebo|||-0.12|-0.58|0.0030
91595009|NCT04041284|183080253|OTHER||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.15|-1.96|||Mixed Models Analysis|||||-1.96|-5.15|<0.0001
91595010|NCT03455491|183080262|SUPERIORITY|||||||0.3541|||||||Gekhan-Wilcoxon test|||||||0.3541
91595011|NCT03455491|183080263|SUPERIORITY|||||||0.3597|||||||Gekhan-Wilcoxon test|||||||0.3597
91595012|NCT03455491|183080265|SUPERIORITY|||||||0.4551|||||||ANOVA|one-way ANOVA||||||0.4551
91595013|NCT00884273|183080272|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Final Values)|2.37||||0.36|TWO_SIDED|95.0|-2.78|7.52||FAS.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.52|-2.78|0.36
91709246|NCT01402986|183311371|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.698|TWO_SIDED|95.0|0.31|2.19|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||2.19|0.31|0.698
91783751|NCT00035932|183447966|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.14|||||TWO_SIDED|97.5|-0.09|0.37||||||||0.37|-0.09|
91783752|NCT00035932|183447966|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.31|||||TWO_SIDED|97.5|0.07|0.55||||||||0.55|0.07|
91783753|NCT00035932|183447967|SUPERIORITY_OR_OTHER||Treatment Difference|0.13|||||TWO_SIDED|95.0|-0.04|0.3||||||||0.30|-0.04|
91783754|NCT00035932|183447967|SUPERIORITY_OR_OTHER||Treatment Difference|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
91783755|NCT00035932|183447970|SUPERIORITY_OR_OTHER||Time-Averaged Difference|0.13|||||TWO_SIDED|97.5|-0.12|0.39||||||||0.39|-0.12|
91783756|NCT00035932|183447970|SUPERIORITY_OR_OTHER||Time-Averaged Distance|0.33|||||TWO_SIDED|97.5|0.07|0.6||||||||0.60|0.07|
91783757|NCT00035932|183447971|SUPERIORITY_OR_OTHER||Difference estimate|-0.5|||||TWO_SIDED|95.0|-13.3|12.3|||||ATV 300/RTV - LPV/RTV|Randomized participants||12.3|-13.3|
91783758|NCT00035932|183447972|SUPERIORITY_OR_OTHER||Difference Estimate|3.6|||||TWO_SIDED|95.0|-7.0|14.1||||||||14.1|-7.0|
91783759|NCT00035932|183447972|SUPERIORITY_OR_OTHER||Difference Estimate|-11.3|||||TWO_SIDED|95.0|-22.9|0.4||||||||0.4|-22.9|
91783760|NCT00035932|183447974|SUPERIORITY_OR_OTHER||Difference Estimate|-5.0|||||TWO_SIDED|95.0|-16.9|7.0||||||||7.0|-16.9|
91595014|NCT00884273|183080281|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Net)|2.24||||0.41|TWO_SIDED|95.0|-3.1|7.58||PP.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.58|-3.10|0.41
91595015|NCT03803059|183080287|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean change from baseline is zero||||<0.01
91595016|NCT03803059|183080288|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||<0.01
91595017|NCT03803059|183080289|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using the Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4.||||<0.01
91595018|NCT03803059|183080290|SUPERIORITY|||||||0.051|||||||t-test, 1 sided|||Calculated using paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.051
91595019|NCT03803059|183080291|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||<0.01
91595020|NCT03803059|183080292|SUPERIORITY|||||||0.331|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.331
91595021|NCT03803059|183080293|SUPERIORITY|||||||0.863|||||||t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.863
91595022|NCT03803059|183080294|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.048
91595023|NCT03803059|183080295|SUPERIORITY|||||||0.355||||||P-value reported is for viscoelastic deformation.|t-test, 2 sided|at significance level alpha+0.05||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.355
91595024|NCT03803059|183080296|SUPERIORITY|||||||0.859||||||Calculated with a paired T test. Testing hypothesis is that the mean change from baseline is zero.|t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.859
91595025|NCT03803059|183080297|EQUIVALENCE|.A binomial (sign) test was performed to test if the the proportion of the combined designated favorable evaluations/responses is equal to the combined designated negative evaluations/responses for each question|||||<|0.01|||||||Sign test|||Patient satisfaction questionnaires were tabulated, and the frequency and percentage of all response options were reported for each question and time point calculated from the binomial (sign) test. The testing hypothesis is that the proportion of favorable responses is equal to the unfavorable||||<0.01
91783761|NCT00035932|183447974|SUPERIORITY_OR_OTHER||Difference Estimate|-16.1|||||TWO_SIDED|95.0|-28.5|-3.7||||||||-3.7|-28.5|
91783762|NCT00035932|183447976|SUPERIORITY_OR_OTHER||Difference Estimate|0.4|||||TWO_SIDED|95.0|-12.5|13.2|||||ATV 300/RTV - LPV/RTV|||13.2|-12.5|
91783763|NCT00035932|183447977|SUPERIORITY_OR_OTHER||Difference Estimate|3.2|||||TWO_SIDED|95.0|-9.1|15.4||||||||15.4|-9.1|
91648859|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00039|STANDARD_ERROR_OF_MEAN|0.001461||0.7881|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7881
91648860|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004717|STANDARD_ERROR_OF_MEAN|0.00141||0.001|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0010
91648861|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004393|STANDARD_ERROR_OF_MEAN|0.002415||0.0693|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0693
91648862|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002959|STANDARD_ERROR_OF_MEAN|0.001887||0.1184|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1184
91648863|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003436|STANDARD_ERROR_OF_MEAN|0.002262||0.1301|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1301
91648864|NCT03593772|183190410|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.006022|STANDARD_ERROR_OF_MEAN|0.003697||0.1049|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1049
91648865|NCT02795780|183190446|OTHER|||||||0.0166||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0166
91648866|NCT02795780|183190446|OTHER|||||||0.0108||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0108
91648867|NCT01364259|183190448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.175|TWO_SIDED||||||Fisher Exact||Our odds ratio is equal to 0\*5/9\*2 because we have a zero cell in the two by two table. Hence the OR = 0.|||||0.175
91648868|NCT01164137|183190455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.87|TWO_SIDED|95.0|-0.98|0.84|||t-test, 2 sided|||||.84|-.98|.87
91648869|NCT01164137|183190456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.32|TWO_SIDED|95.0|-0.62|1.88|||t-test, 2 sided|||||1.88|-.62|.32
91648870|NCT01164137|183190457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.18|TWO_SIDED|95.0|-0.57|3.01|||t-test, 2 sided|||||3.01|-.57|.18
91648871|NCT01164137|183190458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.11|TWO_SIDED|95.0|-0.39|3.81|||t-test, 2 sided|||||3.81|-.39|.11
91648872|NCT01164137|183190459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.85||||0.13|TWO_SIDED|95.0|-0.56|4.27|||t-test, 2 sided|||||4.27|-.56|.13
91648873|NCT03033069|183190470|SUPERIORITY||Least Squares (LS ) Mean Difference|-5.99|||=|0.0021|TWO_SIDED|95.0|-9.79|-2.19|||Mixed Model Repeated Measures (MMRM)|||MMRM analysis with an unstructured (UN) variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-2.19|-9.79|=0.0021
91783764|NCT00035932|183447977|SUPERIORITY_OR_OTHER||Difference Estimate|-16.7|||||TWO_SIDED|95.0|-29.4|-4.0||||||||-4.0|-29.4|
91783765|NCT00035932|183447978|SUPERIORITY_OR_OTHER||Difference Estimate|-1.1|||||TWO_SIDED|95.0|-13.7|11.4||||||||11.4|-13.7|
91783766|NCT00035932|183447978|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-30.6|-5.3||||||||-5.3|-30.6|
91783767|NCT00035932|183447979|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.0|10.3|||Chi-squared, Corrected||ATV 300/RTV - LPV/RTV|||10.3|-15.0|
91783768|NCT00035932|183447980|SUPERIORITY_OR_OTHER||Difference Estimate|-2.3|||||TWO_SIDED|95.0|-14.6|10.0||||||||10.0|-14.6|
91783769|NCT00035932|183447980|SUPERIORITY_OR_OTHER||Difference Estimate|-18.9|||||TWO_SIDED|95.0|-30.7|-7.1||||||||-7.1|-30.7|
91595026|NCT03803059|183080298|SUPERIORITY|||||||0.031||||||All statistical tests were 2-sided at significance level alpha=0.05. No multiple testing corrections were considered in the study.|t-test, 2 sided|||The null hypothesis that the mean change from baseline is zero was tested using a paired t-test||||0.031
91595027|NCT02904915|183080299|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
91595028|NCT02904915|183080300|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
91595029|NCT02904915|183080301|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
91595030|NCT02484911|183080392|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
91595031|NCT02484911|183080393|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
91595032|NCT02484911|183080395|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
91595033|NCT02484911|183080396|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
91783770|NCT00035932|183447981|SUPERIORITY_OR_OTHER||Difference Estimate|-6.4|||||TWO_SIDED|95.0|-18.7|5.8||||||||5.8|-18.7|
91595034|NCT02484911|183080397|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
91648874|NCT03033069|183190470|SUPERIORITY||LS Mean Difference|-1.74|||=|0.3868|TWO_SIDED|95.0|-5.7|2.22|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.22|-5.70|=0.3868
91783771|NCT00035932|183447981|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-29.9|-5.9||||||||-5.9|-29.9|
91783772|NCT00035932|183447983|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-18.4|||||TWO_SIDED|97.5|-44.3|7.5||||||||7.5|-44.3|
91783773|NCT00035932|183447983|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-44.9|||||TWO_SIDED|97.5|-74.5|-15.3||||||||-15.3|-74.5|
91783774|NCT00035932|183447984|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-17.5|||||TWO_SIDED|97.5|-45.6|10.6||||||||10.6|-45.6|
91783775|NCT00035932|183447984|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-47.6|||||TWO_SIDED|97.5|-79.2|-16.1||||||||-16.1|-79.2|
91595035|NCT02484911|183080398|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
91595036|NCT02484911|183080400|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
91595037|NCT02484911|183080401|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
91595038|NCT02484911|183080402|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
91595039|NCT02484911|183080403|SUPERIORITY_OR_OTHER|||||||0.246|||||||Chi-squared|||||||0.246
91595040|NCT03118232|183080417|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|16.6|||<|0.001|TWO_SIDED|95.0|11.0|21.8|||Mixed Models Analysis|||||21.8|11.0|<0.001
91595041|NCT03118232|183080418|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|14.6|||<|0.001|TWO_SIDED|95.0|9.7|19.2|||Mixed Models Analysis|||||19.2|9.7|<0.001
91595042|NCT04036708|183080423|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|2.33||0.77|TWO_SIDED|95.0|-3.93|5.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||5.32|-3.93|.77
91595043|NCT04036708|183080423|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.44||0.9|TWO_SIDED|95.0|-5.14|4.54||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||4.54|-5.14|.90
91595044|NCT04036708|183080424|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|64.03|STANDARD_ERROR_OF_MEAN|24.55||0.01|TWO_SIDED|95.0|15.26|112.8||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||112.8|15.26|.01
91783776|NCT00035932|183447986|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and HIV RNA||||<0.05
91783777|NCT00035932|183447986|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between number of PI Mutations at baseline (\<4; \>=4) of ATV 400 mg / SQV and HIV RNA||||<0.05
91595045|NCT04036708|183080424|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-37.53|STANDARD_ERROR_OF_MEAN|24.86||0.13|TWO_SIDED|95.0|-86.92|11.85||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, and child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||11.85|-86.92|.13
91595046|NCT04036708|183080425|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|2.97||0.55|TWO_SIDED|95.0|-7.65|4.13||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||4.13|-7.65|.55
91648875|NCT03033069|183190470|SUPERIORITY||LS Mean Difference|-0.91|||=|0.6399|TWO_SIDED|95.0|-4.74|2.92|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.92|-4.74|=0.6399
91783778|NCT00035932|183447988|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
91783779|NCT00035932|183447988|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
91783780|NCT00035932|183447988|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between # of PI Mutations at baseline (\<4; \>=4) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
91783781|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-10.9|||||TWO_SIDED|95.0|-15.5|-6.0||||||Total Cholesterol||-6.0|-15.5|
91783782|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-12.4|||||TWO_SIDED|95.0|-16.9|-7.6||||||Total Cholesterol||-7.6|-16.9|
91783783|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-6.7|||||TWO_SIDED|95.0|-13.6|0.7||||||HDL cholesterol||0.7|-13.6|
91783784|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-1.0|||||TWO_SIDED|95.0|-9.3|8.1||||||HDL Cholesterol||8.1|-9.3|
91783785|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-6.8|||||TWO_SIDED|95.0|-15.6|3.0||||||Fasting LDL Cholesterol||3.0|-15.6|
91783786|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-7.3|||||TWO_SIDED|95.0|-15.5|1.8||||||Fasting LDL Cholesterol||1.8|-15.5|
91783787|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-24.9|||||TWO_SIDED|95.0|-35.0|-13.2||||||Fasting Triglycerides||-13.2|-35.0|
91783788|NCT00035932|183447990|SUPERIORITY_OR_OTHER||Difference Estimate|-34.2|||||TWO_SIDED|95.0|-43.4|-23.4||||||Fasting Triglycerides||-23.4|-43.4|
91783789|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-12.1|||||TWO_SIDED|95.0|-17.0|-7.2||||||Total Cholesterol||-7.2|-17.0|
91783790|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-12.0|||||TWO_SIDED|95.0|-17.4|-6.5||||||Total Cholesterol||-6.5|-17.4|
91783791|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-4.4|||||TWO_SIDED|95.0|-12.4|3.5||||||HDL Cholesterol||3.5|-12.4|
91783792|NCT00035932|183447991|SUPERIORITY_OR_OTHER||DIfference Estimate|-0.8|||||TWO_SIDED|95.0|-11.0|9.3||||||HDL Cholesterol||9.3|-11.0|
91783793|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-8.9|||||TWO_SIDED|95.0|-19.0|1.2||||||Fasting LDL CHolesterol||1.2|-19.0|
91783794|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-7.4|||||TWO_SIDED|95.0|-17.7|3.0||||||Fasting LDL Cholesterol||3.0|-17.7|
91783795|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-29.6|||||TWO_SIDED|95.0|-41.6|-17.7||||||Fasting Triglycerides||-17.7|-41.6|
91783796|NCT00035932|183447991|SUPERIORITY_OR_OTHER||Difference Estimate|-38.4|||||TWO_SIDED|95.0|-49.7|-27.1||||||Fasting Triglycerides||-27.1|-49.7|
91783797|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-14.4|||||TWO_SIDED|95.0|-20.1|-8.3|||||ATV 300/RTV - LPV/RTV|Observed values, Total Cholesterol||-8.3|-20.1|
91783798|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-9.0|||||TWO_SIDED|95.0|-16.1|-1.3|||||ATV 400/SQV - LPV/RTV|observed values, total cholesterol||-1.3|-16.1|
91783799|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-11.0|||||TWO_SIDED|95.0|-19.9|-1.2|||||ATV 300/RTV - LPV/RTV|observed values, HDL cholesterol||-1.2|-19.9|
91783800|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-4.1|||||TWO_SIDED|95.0|-14.0|7.0|||||ATV 400/SQV - LPV/RTV|Observed values, HDL cholesterol||7.0|-14.0|
91783801|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-12.7|||||TWO_SIDED|95.0|-22.3|-1.8|||||ATV 300/RTV - LPV/RTV|observed cases, fasting LDL||-1.8|-22.3|
91783802|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-7.9|||||TWO_SIDED|95.0|-19.0|4.8|||||ATV 400/SQV - LPV/RTV|Observed Cases, Fasting LDL cholesterol||4.8|-19.0|
91783803|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-24.8|||||TWO_SIDED|95.0|-38.6|-8.0|||||ATV 300/RTV - LPV/RTV|observed cases, fasting triglycerides||-8.0|-38.6|
91783804|NCT00035932|183447992|SUPERIORITY_OR_OTHER||Difference Estimate|-19.8|||||TWO_SIDED|95.0|-36.5|1.3|||||ATV 400/SQV - LPV/RTV|observed cases, fasting triglycerides||1.3|-36.5|
91783805|NCT00035932|183448003|SUPERIORITY_OR_OTHER||time-averaged difference|0.14|||||TWO_SIDED|97.5|-0.13|0.41|||||ATV 300/RTV - LPV/RTV|overall||0.41|-0.13|
91783806|NCT00035932|183448003|SUPERIORITY_OR_OTHER||time-averaged difference|0.11|||||TWO_SIDED|97.5|-0.16|0.38|||||ATV 300/RTV - LPV/RTV|last observation carried forward||0.38|-0.16|
91783807|NCT02268175|183448011|SUPERIORITY|||||||0.151||||||1-sided|Fisher Exact|||The hypothesis was that treatment with ARM 1 will have a pCR/MRD rate of 35% compared with Arm 2 rate of 10%. Given 75 men randomized in 2:1 ratio to Arm 1 (N=50) or Arm 2 (N=25), there was 84% power to detect this difference, using Fisher's exact test with one-sided type I error of 0.1.||||0.151
91595047|NCT04036708|183080425|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|3.05||0.26|TWO_SIDED|95.0|-9.48|2.63||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.63|-9.48|.26
91595048|NCT04036708|183080426|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|95.0|-0.48|0.16||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.16|-0.48|.32
91648876|NCT03033069|183190470|SUPERIORITY||LS Mean Difference|-5.08|||=|0.0106|TWO_SIDED|95.0|-8.96|-1.2|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-1.20|-8.96|=0.0106
91648877|NCT03033069|183190470|SUPERIORITY||LS Mean Difference|-4.24|||=|0.0384|TWO_SIDED|95.0|-8.26|-0.23|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-0.23|-8.26|=0.0384
91709247|NCT01402986|183311371|SUPERIORITY_OR_OTHER||Rate Ratio|0.55||||0.299|TWO_SIDED|95.0|0.18|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.70|0.18|0.299
91709248|NCT01402986|183311371|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.105|TWO_SIDED|95.0|0.05|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.34|0.05|0.105
91648878|NCT00430638|183190471|SUPERIORITY_OR_OTHER||||||<|0.0001||||||No multiplicity adjustments|ANCOVA|The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91709249|NCT01402986|183311371|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.576|TWO_SIDED|95.0|0.2|2.47|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||2.47|0.20|0.576
91709250|NCT01402986|183311372|SUPERIORITY_OR_OTHER||Rate Ratio|0.48||||0.133|TWO_SIDED|95.0|0.19|1.25|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.25|0.19|0.133
91783808|NCT02100696|183448035|SUPERIORITY||Adjusted difference in response rates|12.2||||0.0033|TWO_SIDED|95.0|3.95|17.67|||Cochran-Mantel-Haenszel|||||17.67|3.95|0.0033
91783809|NCT02100696|183448036|SUPERIORITY||Treatment Difference|3.8||||0.4956|TWO_SIDED|95.0|-7.13|14.56|||Cochran-Mantel-Haenszel|||||14.56|-7.13|0.4956
91783810|NCT02100696|183448037|SUPERIORITY||Adjusted Difference in Remission Rates|12.5||||0.0028|TWO_SIDED|95.0|4.19|17.94||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.94|4.19|0.0028
91783811|NCT02100696|183448038|SUPERIORITY||Adjusted Difference in Response Rates|14.3||||0.0241|TWO_SIDED|95.0|3.21|24.14||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||24.14|3.21|0.0241
91783812|NCT02100696|183448039|SUPERIORITY||Adjusted Difference in Response Rates|8.1||||0.1605|TWO_SIDED|95.0|-2.54|17.22||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.22|-2.54|0.1605
91783813|NCT02100696|183448040|SUPERIORITY||Adjusted Difference in Remission Rates|7.6||||0.3881|TWO_SIDED|95.0|-1.22|13.66||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||13.66|-1.22|0.3881
91783814|NCT02100696|183448041|SUPERIORITY||Adjusted Difference in Remission Rates|4.9||||0.5879|TWO_SIDED|95.0|-6.78|14.69||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.69|-6.78|0.5879
91783815|NCT02100696|183448042|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.0351|TWO_SIDED|95.0|-0.5|0.0||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||-0.0|-0.5|0.0351
91783816|NCT02100696|183448043|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.2698|TWO_SIDED|95.0|-0.4|0.1||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||0.1|-0.4|0.2698
91595049|NCT04036708|183080426|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|95.0|-0.72|-0.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.06|-0.72|.02
91595050|NCT04036708|183080427|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.06|TWO_SIDED|95.0|-0.78|0.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.01|-0.78|.06
91595051|NCT04036708|183080427|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.11|-0.28||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.28|-1.11|.001
91595052|NCT04036708|183080428|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.04|TWO_SIDED|95.0|0.07|2.03||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.03|0.07|.04
91595053|NCT04036708|183080428|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.51||0.07|TWO_SIDED|95.0|-0.08|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||1.96|-0.08|.07
91595054|NCT04036708|183080429|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.01|TWO_SIDED|95.0|1.02|3.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||3.06|1.02|<.01
91595055|NCT04036708|183080429|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.53|<|0.01|TWO_SIDED|95.0|0.67|2.79||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.79|0.67|<.01
91595056|NCT02918864|183080430|SUPERIORITY||Beta Coefficient|-0.22||||0.037|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.037
91648879|NCT00430638|183190472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91783817|NCT02100696|183448044|SUPERIORITY||Difference in Least Square Means|-1.6||||0.2698|TWO_SIDED|95.0|-2.9|-0.3||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||-0.3|-2.9|0.2698
91783818|NCT02100696|183448045|SUPERIORITY||Difference in Least Square Means|-0.5||||0.3881|TWO_SIDED|95.0|-1.0|0.0||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||0.0|-1.0|0.3881
91783819|NCT02100696|183448046|SUPERIORITY||Difference in Adjusted Means|9.1||||0.0445|TWO_SIDED|95.0|0.2|17.9||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||17.9|0.2|0.0445
91783820|NCT02100696|183448047|SUPERIORITY||Adjusted Difference in Remission Rates|0.1||||0.9959|TWO_SIDED|95.0|-19.67|19.88||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||19.88|-19.67|0.9959
91783821|NCT02100696|183448048|SUPERIORITY||Adjusted Difference in Remission Rates|3.8||||0.5014|TWO_SIDED|95.0|-7.26|14.7||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.70|-7.26|0.5014
91783822|NCT02100696|183448049|SUPERIORITY||Adjusted Difference in Remission Rates|0.6||||0.9538|TWO_SIDED|95.0|-19.08|20.35||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||20.35|-19.08|0.9538
91783823|NCT02100696|183448050|SUPERIORITY||Adjusted Difference in Response Rates|14.5||||0.0153|TWO_SIDED|95.0|2.66|25.78||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||25.78|2.66|0.0153
91783824|NCT02100696|183448051|SUPERIORITY||Adjusted Difference in Remission Rates|16.8||||0.0073|TWO_SIDED|95.0|4.44|28.41||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||28.41|4.44|0.0073
91783825|NCT02100696|183448052|SUPERIORITY||Adjusted Difference in Remission Rates|11.9||||0.0174|TWO_SIDED|95.0|1.87|21.71||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.71|1.87|0.0174
91595057|NCT02918864|183080432|SUPERIORITY||Beta Coefficient|-0.23||||0.016|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.016
91595058|NCT02918864|183080434|SUPERIORITY||Beta Coefficient|-0.16||||0.061|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.061
91595059|NCT02918864|183080436|SUPERIORITY||Beta Coefficient|0.03||||0.674|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.674
91595060|NCT02918864|183080438|SUPERIORITY||Beta Coefficient|0.09||||0.191|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.191
91595061|NCT02918864|183080440|SUPERIORITY||Beta Coefficient|0.04||||0.599|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||H0=No significant interaction of Group\*Time||||0.599
91595062|NCT02918864|183080442|SUPERIORITY|||||||0.462||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 12"||||0.462
91595063|NCT02918864|183080443|SUPERIORITY|||||||1||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 16"||||1.000
91595064|NCT02918864|183080444|SUPERIORITY|||||||0.607||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 24"||||0.607
91595065|NCT02918864|183080445|SUPERIORITY||Beta Coefficient|-0.15||||0.31|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.310
91595066|NCT02918864|183080447|SUPERIORITY||Beta Coefficient|-0.2||||0.115|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.115
91783826|NCT02100696|183448053|SUPERIORITY||Adjusted Difference in Remission Rates|7.3||||0.3015|TWO_SIDED|95.0|-6.83|21.6||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.60|-6.83|0.3015
91783827|NCT02100696|183448054|SUPERIORITY||Adjusted Difference in Remission Rates|7.4||||0.2787|TWO_SIDED|95.0|-6.23|21.17||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.17|-6.23|0.2787
91595067|NCT02918864|183080449|SUPERIORITY||Beta Coefficient|-0.08||||0.455|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.455
91595068|NCT02918864|183080451|SUPERIORITY||Beta Coefficient|-0.14||||0.379|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.379
91595069|NCT02918864|183080453|SUPERIORITY||Beta Coefficient|-0.14||||0.275|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.275
91595070|NCT02918864|183080455|SUPERIORITY||Beta Coefficient|-0.2||||0.087|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||||||0.087
91595071|NCT02104583|183080466|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.52||||0.152|TWO_SIDED|95.0|0.86|2.71|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or rest of world (ROW)\].||2.71|0.86|0.152
91783828|NCT02100696|183448055|SUPERIORITY||Difference in Least Square Means|-1.5||||0.0763|TWO_SIDED|95.0|-3.1|0.2||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.2|-3.1|0.0763
91783829|NCT02100696|183448056|SUPERIORITY||Difference in Least Square Means|-0.2||||0.5329|TWO_SIDED|95.0|-1.0|0.5||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.5|-1.0|0.5329
91783830|NCT02100696|183448057|SUPERIORITY||Difference in Adjusted Means|-4.9||||0.2228|TWO_SIDED|95.0|-12.7|3.0||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||3.0|-12.7|0.2228
91783831|NCT01009619|183448072|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
91595072|NCT02104583|183080466|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|0.82||||0.662|TWO_SIDED|95.0|0.34|1.97|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW\].||1.97|0.34|0.662
91595073|NCT02104583|183080466|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.24||||0.618|TWO_SIDED|95.0|0.54|2.86|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW.||2.86|0.54|0.618
91595074|NCT00129766|183080476|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.|Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.503|1.083|||t-test, 2 sided||Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.|ITT population||1.083|0.503|
91595075|NCT00129766|183080485|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.11||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Cochran-Mantel-Haenszel|||||||0.110
91595076|NCT00129766|183080486|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.005||95.0||||No adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF||||||0.005
91595077|NCT00129766|183080487|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.476||95.0|||||Van Eleteren test|Test stratified by presence or absence of CLD of prematurity specified on the CRF||P-value is for overall incidence||||0.476
91595078|NCT00129766|183080488|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.493||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.493
91595079|NCT00129766|183080489|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.652||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.652
91595080|NCT02819635|183080516|SUPERIORITY||Adjusted risk difference (%)|8.4||||0.049|TWO_SIDED|95.0|0.0|16.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||16.8|0.0|0.049
91595081|NCT02819635|183080516|SUPERIORITY||Adjusted risk difference (%)|13.5||||0.01|TWO_SIDED|95.0|3.3|23.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||23.8|3.3|0.010
91595082|NCT02819635|183080516|SUPERIORITY||Adjusted risk difference (%)|13.8||||0.007|TWO_SIDED|95.0|3.8|23.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||23.9|3.8|0.007
91595083|NCT02819635|183080516|SUPERIORITY||Adjusted risk difference (%)|21.1|||<|0.001|TWO_SIDED|95.0|8.6|33.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||33.6|8.6|<0.001
91595084|NCT02819635|183080517|SUPERIORITY||Adjusted risk difference (%)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||27.4|15.8|<0.001
91595085|NCT02819635|183080518|SUPERIORITY||Adjusted risk difference (%)|30.7|||<|0.001|TWO_SIDED|95.0|21.7|39.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||39.8|21.7|<0.001
91783832|NCT01009619|183448073|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
91783833|NCT02954172|183448132|EQUIVALENCE|the equivalence margin of the ORR ratio was set at (0.75, 1.33).|Odds Ratio (OR)|0.9|||||TWO_SIDED|90.0|0.756|1.077||||||||1.077|0.756|
91783834|NCT02954172|183448133|EQUIVALENCE|||||||0.7066|||||||Log Rank|||||||0.7066
91783835|NCT02954172|183448134|EQUIVALENCE|||||||0.3497|||||||Log Rank|||||||0.3497
91595086|NCT02819635|183080518|SUPERIORITY||Adjusted risk difference (%)|39.0|||<|0.001|TWO_SIDED|95.0|29.7|48.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||48.2|29.7|<0.001
91595087|NCT02819635|183080519|SUPERIORITY||Adjusted risk difference (%)|13.1||||0.03|TWO_SIDED|95.0|1.2|25.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||25.0|1.2|0.030
91595088|NCT02819635|183080519|SUPERIORITY||Adjusted risk difference (%)|27.6|||<|0.001|TWO_SIDED|95.0|13.1|42.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||42.1|13.1|<0.001
91595089|NCT02819635|183080519|SUPERIORITY||Adjusted risk difference (%)|26.6|||<|0.001|TWO_SIDED|95.0|12.3|40.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||40.8|12.3|<0.001
91595090|NCT02819635|183080519|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|19.2|51.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||51.7|19.2|<0.001
91595091|NCT02819635|183080520|SUPERIORITY||Adjusted risk difference (%)|11.0||||0.021|TWO_SIDED|95.0|1.7|20.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||20.4|1.7|0.021
91595092|NCT02819635|183080520|SUPERIORITY||Adjusted risk difference (%)|9.6||||0.024|TWO_SIDED|95.0|1.3|18.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||18.0|1.3|0.024
91595093|NCT02819635|183080520|SUPERIORITY||Adjusted risk difference (%)|12.2||||0.015|TWO_SIDED|95.0|2.3|22.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||22.0|2.3|0.015
91595094|NCT02819635|183080520|SUPERIORITY||Adjusted risk difference (%)|20.1||||0.001|TWO_SIDED|95.0|8.0|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||32.1|8.0|0.001
91595095|NCT02819635|183080521|SUPERIORITY||Adjusted risk difference (%)|16.7||||0.038|TWO_SIDED|95.0|0.9|32.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||32.5|0.9|0.038
91595096|NCT02819635|183080521|SUPERIORITY||Adjusted risk difference (%)|35.2|||<|0.001|TWO_SIDED|95.0|17.5|52.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||52.8|17.5|<0.001
91648880|NCT00430638|183190473|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91522089|NCT00406133|182919256|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the \>=25 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||1.0
91522090|NCT00406133|182919257|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.53
91648881|NCT00430638|183190473|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91522091|NCT00406133|182919257|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
91522092|NCT00406133|182919257|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|||||||<0.001
91522093|NCT00406133|182919258|SUPERIORITY_OR_OTHER|||||||0.58||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.58
91522094|NCT00406133|182919258|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.85
91522095|NCT00406133|182919258|SUPERIORITY_OR_OTHER|||||||0.002||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.002
91522096|NCT00406133|182919259|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.18
91522097|NCT00406133|182919259|SUPERIORITY_OR_OTHER|||||||0.44||||||P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.44
91522098|NCT00406133|182919259|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||<0.001
91595097|NCT02819635|183080521|SUPERIORITY||Adjusted risk difference (%)|33.6|||<|0.001|TWO_SIDED|95.0|16.3|50.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||50.8|16.3|<0.001
91595098|NCT02819635|183080521|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|26.2|63.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||63.9|26.2|<0.001
91595099|NCT02819635|183080522|SUPERIORITY||Adjusted risk difference (%)|5.9||||0.495|TWO_SIDED|95.0|-11.1|22.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||22.9|-11.1|0.495
91595100|NCT02819635|183080522|SUPERIORITY||Adjusted risk difference (%)|15.9||||0.074|TWO_SIDED|95.0|-1.6|33.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||33.4|-1.6|0.074
91595101|NCT02819635|183080522|SUPERIORITY||Adjusted risk difference (%)|19.2||||0.033|TWO_SIDED|95.0|1.6|36.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||36.9|1.6|0.033
91595102|NCT02819635|183080522|SUPERIORITY||Adjusted risk difference (%)|40.1|||<|0.001|TWO_SIDED|95.0|20.5|59.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||59.7|20.5|<0.001
91595103|NCT02819635|183080523|SUPERIORITY||LS Mean Difference|-2.142|||<|0.001|TWO_SIDED|95.0|-3.2323|-1.052||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||-1.0520|-3.2323|<0.001
91595104|NCT02819635|183080523|SUPERIORITY||LS Mean Difference|-2.938|||<|0.001|TWO_SIDED|95.0|-4.0284|-1.8478||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||-1.8478|-4.0284|<0.001
91595105|NCT02819635|183080523|SUPERIORITY||LS Mean Difference|-3.736|||<|0.001|TWO_SIDED|95.0|-4.8247|-2.647||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||-2.6470|-4.8247|<0.001
91595106|NCT02819635|183080523|SUPERIORITY||LS Mean Difference|-4.061|||<|0.001|TWO_SIDED|95.0|-5.1252|-2.9974||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||-2.9974|-5.1252|<0.001
91648882|NCT00430638|183190474|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91648883|NCT00430638|183190474|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91648884|NCT00430638|183190475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91790404|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91522099|NCT00406133|182919260|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.29
91595107|NCT02819635|183080524|SUPERIORITY||Adjusted risk difference (%)|6.6||||0.075|TWO_SIDED|95.0|-0.7|13.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||13.9|-0.7|0.075
91595108|NCT02819635|183080524|SUPERIORITY||Adjusted risk difference (%)|3.8||||0.199|TWO_SIDED|95.0|-2.0|9.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||9.6|-2.0|0.199
91595109|NCT02819635|183080524|SUPERIORITY||Adjusted risk difference (%)|11.1||||0.015|TWO_SIDED|95.0|2.2|20.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||20.0|2.2|0.015
91595110|NCT02819635|183080524|SUPERIORITY||Adjusted risk difference (%)|17.8||||0.004|TWO_SIDED|95.0|5.8|29.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||29.9|5.8|0.004
91595111|NCT02819635|183080525|SUPERIORITY||Adjusted risk difference (%)|25.6||||0.003|TWO_SIDED|95.0|8.9|42.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||42.3|8.9|0.003
91595112|NCT02819635|183080525|SUPERIORITY||Adjusted risk difference (%)|43.6|||<|0.001|TWO_SIDED|95.0|25.4|61.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||61.8|25.4|<0.001
91595113|NCT02819635|183080525|SUPERIORITY||Adjusted risk difference (%)|39.4|||<|0.001|TWO_SIDED|95.0|21.3|57.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||57.5|21.3|<0.001
91595114|NCT02819635|183080525|SUPERIORITY||Adjusted risk difference (%)|43.1|||<|0.001|TWO_SIDED|95.0|24.4|61.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||61.9|24.4|<0.001
91595115|NCT02819635|183080526|SUPERIORITY||Adjusted risk difference (%)|29.3|||<|0.001|TWO_SIDED|95.0|22.6|35.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.9|22.6|<0.001
91790405|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.29|TWO_SIDED|95.0|-0.574|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.574|0.290
91790406|NCT02880956|183460063|SUPERIORITY||effect size|0.13|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790407|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.191||0.541|TWO_SIDED|95.0|-0.492|0.258||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.258|-0.492|0.541
91790408|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91595116|NCT02819635|183080527|SUPERIORITY||Adjusted risk difference (%)|12.7|||<|0.001|TWO_SIDED|95.0|8.4|17.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||17.0|8.4|<0.001
91595117|NCT02819635|183080528|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|38.4|54.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||54.2|38.4|<0.001
91595118|NCT02819635|183080529|SUPERIORITY||Adjusted risk difference (%)|33.3|||<|0.001|TWO_SIDED|95.0|24.8|41.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)||Substudy 2: Upadacitinib 45 mg vs Placebo|Difference = Upadacitinib 45 mg - Placebo|41.8|24.8|<0.001
91595119|NCT02819635|183080530|SUPERIORITY||Adjusted risk difference (%)|23.7|||<|0.001|TWO_SIDED|95.0|17.5|30.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||30.0|17.5|<0.001
91595120|NCT02819635|183080531|SUPERIORITY||Adjusted risk difference (%)|27.4|||<|0.001|TWO_SIDED|95.0|19.2|35.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.6|19.2|<0.001
91595121|NCT02819635|183080532|SUPERIORITY||Adjusted risk difference (%)|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||32.1|15.1|<0.001
91595122|NCT02819635|183080533|SUPERIORITY||Adjusted risk difference (%)|32.2|||<|0.001|TWO_SIDED|95.0|23.8|40.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.7|23.8|<0.001
91595123|NCT02819635|183080534|SUPERIORITY||Least Squares (LS) Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|27.02|40.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.36|27.02|<0.001
91595124|NCT02819635|183080535|SUPERIORITY||Adjusted risk difference (%)|9.7|||<|0.001|TWO_SIDED|95.0|5.7|13.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||13.7|5.7|<0.001
91595125|NCT02819635|183080536|SUPERIORITY||Least Squares (LS) Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|4.79|8.59||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||8.59|4.79|<0.001
91648885|NCT00430638|183190475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
91648886|NCT00430638|183190476|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - \> or equal to 65 years old): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0125
91595126|NCT02819635|183080537|SUPERIORITY||Adjusted risk difference (%)|34.4|||<|0.001|TWO_SIDED|95.0|25.1|43.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||43.7|25.1|<0.001
91595127|NCT02819635|183080537|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|36.7|55.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||55.8|36.7|<0.001
91595128|NCT02819635|183080538|SUPERIORITY||Adjusted risk difference (%)|37.4|||<|0.001|TWO_SIDED|95.0|20.3|54.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.6|20.3|<0.001
91595129|NCT02819635|183080538|SUPERIORITY||Adjusted risk difference (%)|47.0|||<|0.001|TWO_SIDED|95.0|30.7|63.3||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||63.3|30.7|<0.001
91595130|NCT02819635|183080539|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|18.2|52.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||52.7|18.2|<0.001
91595131|NCT02819635|183080539|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|28.7|61.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.6|28.7|<0.001
91595132|NCT02819635|183080540|SUPERIORITY||Adjusted risk difference (%)|42.0|||<|0.001|TWO_SIDED|95.0|27.8|56.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||56.2|27.8|<0.001
91595133|NCT02819635|183080540|SUPERIORITY||Adjusted risk difference (%)|48.6|||<|0.001|TWO_SIDED|95.0|35.5|61.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.7|35.5|<0.001
91595134|NCT02819635|183080541|SUPERIORITY||Adjusted risk difference (%)|18.7|||<|0.001|TWO_SIDED|95.0|11.0|26.4||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||26.4|11.0|<0.001
91595135|NCT02819635|183080541|SUPERIORITY||Adjusted risk difference (%)|19.4|||<|0.001|TWO_SIDED|95.0|11.7|27.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||27.2|11.7|<0.001
91595136|NCT02819635|183080542|SUPERIORITY||Adjusted risk difference (%)|44.6|||<|0.001|TWO_SIDED|95.0|34.5|54.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.7|34.5|<0.001
91595137|NCT02819635|183080542|SUPERIORITY||Adjusted risk difference (%)|56.6|||<|0.001|TWO_SIDED|95.0|47.2|66.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||66.0|47.2|<0.001
91648887|NCT00430638|183190476|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) \> or equal to 65): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0006
91595138|NCT02819635|183080543|SUPERIORITY||Adjusted risk difference (%)|23.8|||<|0.001|TWO_SIDED|95.0|14.8|32.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||32.8|14.8|<0.001
91595139|NCT02819635|183080543|SUPERIORITY||Adjusted risk difference (%)|37.3|||<|0.001|TWO_SIDED|95.0|27.8|46.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||46.8|27.8|<0.001
91595140|NCT02819635|183080544|SUPERIORITY||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|4.77|<|0.001|TWO_SIDED|95.0|21.98|40.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||40.70|21.98|<0.001
91595141|NCT02819635|183080544|SUPERIORITY||LS Mean Difference|41.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|31.39|50.55||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||50.55|31.39|<0.001
91595142|NCT02819635|183080545|SUPERIORITY||Adjusted risk difference (%)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|20.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||20.0|6.0|<0.001
91595143|NCT02819635|183080545|SUPERIORITY||Adjusted risk difference (%)|13.6|||<|0.001|TWO_SIDED|95.0|6.6|20.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||20.6|6.6|<0.001
91595144|NCT02819635|183080546|SUPERIORITY||Adjusted risk difference (%)|38.7|||<|0.001|TWO_SIDED|95.0|28.9|48.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||48.5|28.9|<0.001
91595145|NCT02819635|183080546|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|35.5|54.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||54.8|35.5|<0.001
91595146|NCT02819635|183080547|SUPERIORITY||Adjusted risk difference (%)|24.3|||<|0.001|TWO_SIDED|95.0|14.2|34.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||34.5|14.2|<0.001
91595147|NCT02819635|183080547|SUPERIORITY||Adjusted risk difference (%)|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.9||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||43.9|23.6|<0.001
91595148|NCT02819635|183080548|SUPERIORITY||LS Mean Difference|5.1|||<|0.001|TWO_SIDED|95.0|2.67|7.52||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||7.52|2.67|<0.001
91595149|NCT02819635|183080548|SUPERIORITY||LS Mean Difference|5.9|||<|0.001|TWO_SIDED|95.0|3.44|8.27||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||8.27|3.44|<0.001
91595150|NCT05433571|183080560|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.917|STANDARD_ERROR_OF_MEAN|0.0194|||TWO_SIDED|95.0|0.878|0.955|||Bootstrapping Methods|bias adjusted confidence intervals||||0.955|0.878|
91595151|NCT05433571|183080560|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.887|STANDARD_ERROR_OF_MEAN|0.0219|||TWO_SIDED|95.0|0.845|0.93|||Bootstrapping Methods|bias adjusted confidence intervals||||0.930|0.845|
91595152|NCT01476475|183080575|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of insulin glargine/lixisenatide FRC versus insulin glargine was tested first, at alpha level of 0.025 (1-sided) and a non-inferiority margin of 0.4% HbA1c. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided). The non-inferiority was assessed using upper bound of 2-sided 95% confidence interval (CI) at ≤0.4%.|Least square (LS) mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.312|-0.037|||ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. A step-down testing procedure described by Hochberg and Tamhane was used to control type-1 error.||-0.037|-0.312|
91595153|NCT01476475|183080575|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.312|-0.037||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided).||-0.037|-0.312|0.0130
91595154|NCT01476475|183080576|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.17|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-3.832|-2.504||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA with treatment groups,randomization strata of screening HbA1c(\<8.0, ≥8.0%)\& screening BMI(\<30 kg/m\^2, ≥30 kg/m\^2),country as fixed effects and baseline 2-hour PPG value as covariates.A step-down testing procedure used to control type-1 error.If non-inferiority demonstrated for primary endpoint,superiority testing on secondary endpoints was performed sequentially in order endpoints are reported(continued only if previous endpoint was statistically significant).||-2.504|-3.832|<0.0001
91595155|NCT01476475|183080577|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.331|<|0.0001|TWO_SIDED|95.0|-3.895|-2.592||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline 2-hour plasma glucose excursion value as covariates.||-2.592|-3.895|<0.0001
91595156|NCT01476475|183080578|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.125||0.0154|TWO_SIDED|95.0|-0.55|-0.058||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline average 7-point SMPG value as covariates.||-0.058|-0.550|0.0154
91595157|NCT01476475|183080579|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.11|-0.773||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline body weight value as covariates.||-0.773|-2.110|<0.0001
91595158|NCT01476475|183080580|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.704||0.0583|TWO_SIDED|95.0|-6.592|0.114||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects.||0.114|-6.592|0.0583
91595159|NCT00676676|183080599|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Baseline versus 2-week||||0.002
91595160|NCT00676676|183080599|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Baseline versus 8-week||||0.004
91595161|NCT01918007|183080601|SUPERIORITY||Odds Ratio (OR)|1.3||||0.54|TWO_SIDED|95.0|0.5|3.3|||Chi-squared|||||3.3|0.5|0.54
91595162|NCT01918007|183080602|SUPERIORITY||Odds Ratio (OR)|14.0|||<|0.001|TWO_SIDED|95.0|2.9|68.4|||Chi-squared|||||68.4|2.9|<0.001
91595163|NCT01918007|183080603|SUPERIORITY||Mean Difference (Net)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.35|-0.27|||t-test, 2 sided|||||-0.27|-0.35|<0.001
91595164|NCT01918007|183080604|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91648888|NCT00430638|183190477|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91595165|NCT01918007|183080605|SUPERIORITY||Mean Difference (Net)|-2.76|||<|0.001|TWO_SIDED|95.0|-3.63|-1.9|||t-test, 2 sided|||||-1.90|-3.63|<0.001
91595166|NCT01918007|183080606|SUPERIORITY||Risk Ratio (RR)|1.16||||0.553|TWO_SIDED|95.0|0.71|1.89|||Chi-squared|||||1.89|0.71|0.553
91595167|NCT01918007|183080607|SUPERIORITY||Risk Ratio (RR)|1.79||||0.057|TWO_SIDED|95.0|0.98|3.27|||Chi-squared|||||3.27|0.98|0.057
91595168|NCT01918007|183080608|SUPERIORITY||Risk Ratio (RR)|2.29||||0.084|TWO_SIDED|95.0|0.84|6.25|||Chi-squared|||||6.25|0.84|0.084
91648889|NCT00430638|183190477|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91648890|NCT00430638|183190478|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91648891|NCT00430638|183190478|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91595169|NCT01918007|183080609|SUPERIORITY|||||||0.547|||||||Wilcoxon (Mann-Whitney)|||||||0.547
91595170|NCT01918007|183080610|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
91595171|NCT01918007|183080611|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
91595172|NCT01918007|183080612|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
91595173|NCT01918007|183080613|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
91595174|NCT01372384|183080619|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 4 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed.||||0.045
91595175|NCT01372384|183080619|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 6 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed||||1.000
91648892|NCT00430638|183190479|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91648893|NCT00430638|183190479|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91783836|NCT00233064|183448135|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.0||||||95.0|0.0|1.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.9|0.0|
91783837|NCT00233064|183448135|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.5||||||95.0|0.0|2.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||2.9|0.0|
91595176|NCT01372384|183080619|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 6 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||1.000
91595177|NCT01372384|183080619|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Progression of disease at Visit 6 (Two proportions for of Stable Disease Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Stable Disease Vs Progression of disease was analyzed||||1.000
91595178|NCT01372384|183080619|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 10 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||0.274
91595179|NCT01471015|183080630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
91595180|NCT01471015|183080631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
91595181|NCT04962022|183080637|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|118.57||||0.05|TWO_SIDED|90.0|112.5|124.97|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||124.97|112.50|0.05
91595182|NCT04962022|183080638|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|138.82||||0.05|TWO_SIDED|90.0|129.25|149.11|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||149.11|129.25|0.05
91595183|NCT00330382|183080658|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.11|||>|0.45|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area||||>0.45
91595184|NCT00330382|183080658|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.92|||>|0.88|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in protease activity with relative percent change in total lesion area||||> 0.88
91595185|NCT00330382|183080658|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.07|||>|0.66|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in serum Neu with relative percent change in total lesion area||||> 0.66
91595186|NCT02684604|183080659|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91595187|NCT02285777|183080682|OTHER|Pre-specified.|Vaccine Effectiveness|71.0||||0.0001|TWO_SIDED|95.0|69.0|73.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains was computed by mean of a generalized linear model.||73|69|0.0001
91595188|NCT02285777|183080683|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|55.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||55|48|0.0001
91595189|NCT02285777|183080684|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|54.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||54|48|0.0001
91595190|NCT02285777|183080684|OTHER|Pre-specified.|Vaccine Effectiveness|24.0||||0.0001||95.0|20.0|28.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||28|20|0.0001
91595191|NCT00552175|183080706|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.17|-0.56|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.||-0.56|-1.17|<0.0001
91595192|NCT00552175|183080708|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.64||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.64|-1.27|<0.0001
91595193|NCT00552175|183080708|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.51||P-value for Night Pain.|Mixed Models Analysis|Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.51|-1.15|<0.0001
91595194|NCT00552175|183080709|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||||TWO_SIDED|95.0|-1.26|-0.49|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.49|-1.26|
91595195|NCT00552175|183080709|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.43|-0.66|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.66|-1.43|
91595196|NCT00552175|183080709|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.39|-1.17|
91595197|NCT00552175|183080709|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.28|-0.5|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.5|-1.28|
91595198|NCT00552175|183080710|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.44|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.44|-0.85|<0.0001
91595199|NCT00552175|183080711|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.9|-0.39|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.39|-0.9|
91595200|NCT00552175|183080711|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.91|-0.4|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.4|-0.91|
91648894|NCT00430638|183190480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91648895|NCT00430638|183190480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
91648896|NCT01529749|183190481|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648897|NCT01529749|183190482|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648898|NCT01529749|183190483|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648899|NCT01529749|183190484|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648900|NCT01529749|183190485|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648901|NCT01529749|183190486|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648902|NCT01529749|183190487|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91522100|NCT00406133|182919260|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
91595201|NCT00552175|183080712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.61||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.61|-1.34|<0.0001
91595202|NCT00552175|183080712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.48||P-value for Least Pain.|Mixed Models Analysis|Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.48|-1.21|<0.0001
91648903|NCT01529749|183190488|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648904|NCT01529749|183190489|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91648905|NCT01529749|183190490|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648906|NCT01529749|183190491|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648907|NCT01529749|183190492|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648908|NCT01529749|183190493|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648909|NCT01529749|183190494|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648910|NCT01529749|183190495|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
91648911|NCT01529749|183190496|SUPERIORITY|||||||0.49|||||||Chi-squared, Corrected|||||||0.49
91648912|NCT01529749|183190497|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
91709251|NCT01402986|183311372|SUPERIORITY_OR_OTHER||Rate Ratio|0.46||||0.241|TWO_SIDED|95.0|0.13|1.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.67|0.13|0.241
91783838|NCT00233064|183448135|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.3||||||95.0|0.0|1.5|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.5|0.0|
91595203|NCT00552175|183080712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.67||P-value for Average Pain.|Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.67|-1.33|<0.0001
91595204|NCT00552175|183080712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||P-value for Pain Right Now.|Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.54|-1.29|<0.0001
91595205|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.34|-0.44|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.44|-1.34|
91595206|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.06|||||TWO_SIDED|95.0|-1.51|-0.62|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.62|-1.51|
91595207|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.23|-0.33|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.33|-1.23|
91595208|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Mean Squares Difference|-0.91|||||TWO_SIDED|95.0|-1.36|-0.46|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.46|-1.36|
91595209|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||||TWO_SIDED|95.0|-1.39|-0.58|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.58|-1.39|
91595210|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.01|||||TWO_SIDED|95.0|-1.41|-0.61|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.61|-1.41|
91709252|NCT01402986|183311372|SUPERIORITY_OR_OTHER||Rate Ratio|0.59||||0.51|TWO_SIDED|95.0|0.12|2.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.84|0.12|0.510
91790409|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.186||0.617|TWO_SIDED|95.0|-0.459|0.272||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.272|-0.459|0.617
91595211|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|||||TWO_SIDED|95.0|-1.35|-0.41|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.41|-1.35|
91595212|NCT00552175|183080713|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||||TWO_SIDED|95.0|-1.41|-0.48|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.48|-1.41|
91595213|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41||||0.0676|TWO_SIDED|95.0|-0.85|0.03||P-value for General Activity.|Mixed Models Analysis|Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.03|-0.85|0.0676
91790410|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790411|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.457|TWO_SIDED|95.0|-0.517|0.233||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.233|-0.517|0.457
91790412|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790413|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|0.22|STANDARD_ERROR_OF_MEAN|0.188||0.245|TWO_SIDED|95.0|-0.151|0.59||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.590|-0.151|0.245
91790414|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91595214|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37||||0.0933|TWO_SIDED|95.0|-0.8|0.06||P-value for Mood.|Mixed Models Analysis|Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.06|-0.8|0.0933
91595215|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.0228|TWO_SIDED|95.0|-0.91|-0.07||P-value for Walking Ability.|Mixed Models Analysis|Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.07|-0.91|0.0228
91595216|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.38||||0.0783|TWO_SIDED|95.0|-0.8|0.04||P-value for Normal Work.|Mixed Models Analysis|Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.04|-0.8|0.0783
91595217|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55||||0.0076|TWO_SIDED|95.0|-0.96|-0.15||P-value for Relation to People.|Mixed Models Analysis|Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.15|-0.96|0.0076
91595218|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46||||0.0378|TWO_SIDED|95.0|-0.9|-0.03||P-value for Sleep.|Mixed Models Analysis|Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.03|-0.9|0.0378
91595219|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.0089|TWO_SIDED|95.0|-0.98|-0.14||P-value for Enjoyment of Life.|Mixed Models Analysis|Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.14|-0.98|0.0089
91595220|NCT00552175|183080714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48||||0.0095|TWO_SIDED|95.0|-0.85|-0.12||P-value for Average of Interference Scores|Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.12|-0.85|0.0095
91595221|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.14|-0.06|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||-0.06|-1.14|
91595222|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.77|0.32|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||0.32|-0.77|
91595223|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.8|0.27|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.27|-0.8|
91595224|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.05|-1.01|
91709253|NCT01402986|183311372|SUPERIORITY_OR_OTHER||Rate Ratio|0.74||||0.661|TWO_SIDED|95.0|0.19|2.85|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.85|0.19|0.661
91709254|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.79||||0.057|TWO_SIDED|95.0|-0.21|13.79|||Repeated measure model|||Baseline serum periostin \>= median||13.79|-0.21|0.057
91595225|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.02|0.02|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.02|-1.02|
91595226|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49|||||TWO_SIDED|95.0|-1.01|0.03|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.03|-1.01|
91709255|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.57||||0.874|TWO_SIDED|95.0|-6.54|7.68|||Repeated measure model|||Baseline serum periostin \>= median||7.68|-6.54|0.874
91595227|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.35|||||TWO_SIDED|95.0|-0.86|0.16|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.16|-0.86|
91595228|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.92|0.11|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.11|-0.92|
91595229|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|||||TWO_SIDED|95.0|-0.89|0.11|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||0.11|-0.89|
91595230|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.21|-0.22|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||-0.22|-1.21|
91595231|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.57|||||TWO_SIDED|95.0|-1.11|-0.03|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||-0.03|-1.11|
91595232|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||0.18|-0.9|
91648913|NCT02623426|183190509|SUPERIORITY||Ratio of the proportion of baseline|1.36|||<|0.001|TWO_SIDED|95.0|1.19|1.56||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Methotrexate/Ozurdex). Values greater than 1 indicate less reduction in retinal thickness in the Methotrexate treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for Methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.56|1.19|<0.001
91709256|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.37||||0.028|TWO_SIDED|95.0|0.8|13.95|||Repeated measure model|||Baseline serum periostin \< median||13.95|0.80|0.028
91595233|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37|||||TWO_SIDED|95.0|-0.88|0.15|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||0.15|-0.88|
91595234|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||||TWO_SIDED|95.0|-1.27|-0.24|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||-0.24|-1.27|
91709257|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.09||||0.745|TWO_SIDED|95.0|-5.48|7.66|||Repeated measure model|||Baseline serum periostin \< median||7.66|-5.48|0.745
91595235|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|||||TWO_SIDED|95.0|-0.9|0.0|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||0|-0.9|
91709258|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.12||||0.011|TWO_SIDED|95.0|1.66|12.58|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||12.58|1.66|0.011
91595236|NCT00552175|183080715|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.52|||||TWO_SIDED|95.0|-0.97|-0.07|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||-0.07|-0.97|
91595237|NCT00552175|183080716|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11||||0.8517|TWO_SIDED|95.0|-1.22|1.01|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.01|-1.22|0.8517
91595238|NCT00552175|183080717|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34|||||TWO_SIDED|95.0|-1.03|1.71|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.71|-1.03|
91709259|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.48||||0.863|TWO_SIDED|95.0|-5.93|4.97|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||4.97|-5.93|0.863
91709260|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.24||||0.221|TWO_SIDED|95.0|-3.8|16.27|||Repeated measure model|||Baseline serum periostin \< 25th percentile||16.27|-3.80|0.221
91783839|NCT01120964|183448161|OTHER|Analyses presented herein are for re-intubation time included.|Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||"Total duration of postoperative invasive mechanical ventilation was analyzed by treatment group using summary statistics, and was compared between citrulline and placebo groups using an ANOVA.~Kaplan-Meier analyses were performed for: 1) zero durations censored, 2) zero durations uncensored, 3) patients with zero duration excluded. The same analyses were performed with re-intubation time removed."||73.4|-9.5|0.0222
91783840|NCT01120964|183448162|OTHER||Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||Re-intubation time included. Threshold for significance was p\<0.05|t-test, 2 sided|||Analyses presented herein are for re-intubation time included.||73.4|-9.5|0.0222
91595239|NCT00552175|183080717|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|||||TWO_SIDED|95.0|-1.92|0.81|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.81|-1.92|
91595240|NCT03548935|183080723|SUPERIORITY||Treatment difference|-12.44|||<|0.0001|TWO_SIDED|95.0|-13.37|-11.51|||ANCOVA|||Treatment policy estimand||-11.51|-13.37|<.0001
91595241|NCT03548935|183080723|SUPERIORITY||Treatment difference|-14.42|||<|0.0001|TWO_SIDED|95.0|-15.29|-13.55|||ANCOVA|||Hypothetical estimand||-13.55|-15.29|<0.0001
91595242|NCT03548935|183080724|SUPERIORITY||Odds Ratio (OR)|11.22|||<|0.0001|TWO_SIDED|95.0|8.88|14.19|||Regression, Logistic|||Treatment policy estimand||14.19|8.88|<0.0001
91595243|NCT03548935|183080724|SUPERIORITY||Odds Ratio (OR)|37.03|||<|0.0001|TWO_SIDED|95.0|28.02|48.95|||Regression, Logistic|||Hypothetical estimand||48.95|28.02|<0.0001
91595244|NCT04677959|183080765|OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0||||||||The 95% credible intervals of the odds ratio from the posterior distributions were calculated and presented.||||
91595245|NCT01074190|183080789|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||.34
91783841|NCT01120964|183448163|OTHER||Mean Difference (Final Values)|50.7||||0.0418|TWO_SIDED|95.0|5.4|96.0||The threshold for significance was P\<0.05|Wilcoxon (Mann-Whitney)|||||96.0|5.4|0.0418
91783842|NCT01120964|183448164|OTHER||Mean Difference (Final Values)|12.7||||0.0727|TWO_SIDED|95.0|-2.6|28.1||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||28.1|-2.6|0.0727
91783843|NCT01120964|183448165|OTHER||Mean Difference (Final Values)|559.8||||0.1271|TWO_SIDED|95.0|-193.5|1313.2|||Wilcoxon (Mann-Whitney)|||||1313.2|-193.5|0.1271
91595246|NCT01074190|183080790|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.1
91595247|NCT01074190|183080791|SUPERIORITY|||||||0.1|||||||Chi-squared|||A sample size of 315 achieves 80% power to detect a difference among groups using a 2 degrees of freedom Chi-Square Test with a significance level (alpha) of 0.05.||||.1
91595248|NCT00804570|183080794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.12|TWO_SIDED|95.0|-9.72|1.13|||Mixed Models Analysis|||||1.13|-9.72|0.120
91595249|NCT00804570|183080795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.013|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||||-0.15|-1.27|0.013
91595250|NCT00804570|183080796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.37||||0.051|TWO_SIDED|95.0|-0.02|10.77|||Mixed Models Analysis|||||10.77|-0.02|0.051
91595251|NCT00804570|183080797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.249|TWO_SIDED|95.0|-1.07|0.28|||Mixed Models Analysis|||||0.28|-1.07|0.249
91595252|NCT00804570|183080798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.199|TWO_SIDED|95.0|-1.12|0.23|||Mixed Models Analysis|||||0.23|-1.12|0.199
91595253|NCT00804570|183080799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.318|TWO_SIDED|95.0|-2.03|0.66|||Mixed Models Analysis|||||0.66|-2.03|0.318
91595254|NCT00804570|183080800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.034|TWO_SIDED|95.0|-5.8|-0.22|||Mixed Models Analysis|||||-0.22|-5.80|0.034
91595255|NCT00804570|183080801|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.9||||0.001|TWO_SIDED|95.0|0.85|0.96|||Mixed Models Analysis|||||0.96|0.85|0.001
91595256|NCT00804570|183080802|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.96||||0.103|TWO_SIDED|95.0|0.91|1.01|||Mixed Models Analysis|||||1.01|0.91|0.103
91595257|NCT00804570|183080803|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.94||||0.012|TWO_SIDED|95.0|0.89|0.99|||Mixed Models Analysis|||||0.99|0.89|0.012
91595258|NCT00804570|183080804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32||||0.392|TWO_SIDED|95.0|-1.05|0.41|||Mixed Models Analysis|||||0.41|-1.05|0.392
91595259|NCT00804570|183080805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.185|TWO_SIDED|95.0|-1.1|0.21|||Mixed Models Analysis|||||0.21|-1.10|0.185
91595260|NCT00804570|183080806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.142|TWO_SIDED|95.0|-0.42|2.92|||ANCOVA|||||2.92|-0.42|0.142
91709261|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.58||||0.108|TWO_SIDED|95.0|-1.91|19.07|||Repeated measure model|||Baseline serum periostin \< 25th percentile||19.07|-1.91|0.108
91783844|NCT01120964|183448166|OTHER||Mean Difference (Final Values)|3.5||||0.972|TWO_SIDED|95.0|-7.0|14.1|||Wilcoxon (Mann-Whitney)|||||14.1|-7.0|0.9720
91783845|NCT01120964|183448167|OTHER||Mean Difference (Final Values)|5.2||||0.8884|TWO_SIDED|95.0|-7.7|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-7.7|0.8884
91783846|NCT01120964|183448168|OTHER|Total number of postoperative hours spent in PICU|Mean Difference (Final Values)|69.14||||0.1891|TWO_SIDED|95.0|-49.39|187.67||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||187.67|-49.39|0.1891
91783847|NCT01120964|183448169|OTHER||Mean Difference (Final Values)|30.2||||0.0479|TWO_SIDED|95.0|-10.8|71.1||Duration including re-intubation time. Threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||71.1|-10.8|0.0479
91648914|NCT02623426|183190509|SUPERIORITY||Ratio of the proportion of BL|1.22||||0.012|TWO_SIDED|95.0|1.04|1.43||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Lucentis/Ozurdex) at 12 weeks. Values greater than 1 indicate less reduction in retinal thickness in the Lucentis treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.43|1.04|0.012
91648915|NCT02094937|183190510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.31|2.49||||||||2.49|0.31|
91648916|NCT02094937|183190510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.28|2.19||||||||2.19|0.28|
91648917|NCT02094937|183190511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.9|4.12||||||||4.12|0.90|
91648918|NCT02094937|183190511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.66|3.2||||||||3.20|0.66|
91648919|NCT05166421|183190536|OTHER||Geometric mean ratio|0.938|||||TWO_SIDED|90.0|0.8458|1.0403||||||Statistical Comparison of AUCinf of AZD7442||1.0403|0.8458|
91648920|NCT05166421|183190536|OTHER||Geometric mean ratio|0.9968|||||TWO_SIDED|90.0|0.898|1.1066||||||Statistical Comparison of AUCinf of AZD7442||1.1066|0.8980|
91648921|NCT05166421|183190536|OTHER||Geometric mean ratio|1.0627|||||TWO_SIDED|90.0|0.9579|1.179||||||Statistical Comparison of AUCinf of AZD7442||1.1790|0.9579|
91648922|NCT05166421|183190536|OTHER||Geometric mean ratio|0.8992|||||TWO_SIDED|90.0|0.8107|0.9974||||||Statistical Comparison of AUCinf of AZD8895||0.9974|0.8107|
91648923|NCT05166421|183190536|OTHER||Geometric mean ratio|0.9826|||||TWO_SIDED|90.0|0.8854|1.0905||||||Statistical Comparison of AUCinf of AZD8895||1.0905|0.8854|
91648924|NCT05166421|183190536|OTHER||Geometric mean ratio|1.0928|||||TWO_SIDED|90.0|0.9853|1.212||||||Statistical Comparison of AUCinf of AZD8895||1.2120|0.9853|
91648925|NCT05166421|183190536|OTHER||Geometric mean ratio|1.0039|||||TWO_SIDED|90.0|0.9029|1.1161||||||Statistical Comparison of AUCinf of AZD1061||1.1161|0.9029|
91648926|NCT05166421|183190536|OTHER||Geometric mean ratio|1.0336|||||TWO_SIDED|90.0|0.9288|1.1503||||||Statistical Comparison of AUCinf of AZD1061||1.1503|0.9288|
91648927|NCT05166421|183190536|OTHER||Geometric mean ratio|1.0296|||||TWO_SIDED|90.0|0.9258|1.1451||||||Statistical Comparison of AUCinf of AZD1061||1.1451|0.9258|
91648928|NCT05166421|183190537|OTHER||Geometric mean ratio|0.9418|||||TWO_SIDED|90.0|0.8512|1.0421||||||Statistical Comparison of AUClast of AZD7442||1.0421|0.8512|
91783848|NCT01120964|183448170|OTHER||Mean Difference (Final Values)|3.7||||0.2637|TWO_SIDED|95.0|-2.2|9.7|||Wilcoxon (Mann-Whitney)|||||9.7|-2.2|0.2637
91783849|NCT01120964|183448172|OTHER||Mean Difference (Final Values)|7.5||||0.6431|TWO_SIDED|95.0|-25.9|41.0|||t-test, 2 sided|||||41.0|-25.9|0.6431
91783850|NCT01120964|183448173|OTHER||Mean Difference (Final Values)|39.5||||0.6408|TWO_SIDED|95.0|-134.2|213.1|||ANOVA|||||213.1|-134.2|0.6408
91648929|NCT05166421|183190537|OTHER||Geometric mean ratio|0.9973|||||TWO_SIDED|90.0|0.9004|1.1046||||||Statistical Comparison of AUClast of AZD7442||1.1046|0.9004|
91648930|NCT05166421|183190537|OTHER||Geometric mean ratio|1.0589|||||TWO_SIDED|90.0|0.9559|1.173||||||Statistical Comparison of AUClast of AZD7442||1.1730|0.9559|
91648931|NCT05166421|183190537|OTHER||Geometric mean ratio|0.8812|||||TWO_SIDED|90.0|0.7933|0.9788||||||Statistical Comparison of AUClast of AZD8895||0.9788|0.7933|
91783851|NCT00826202|183448185|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|cohen's d= 0.67||||||0.07
91783852|NCT00826202|183448186|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED||||||t-test, 2 sided|cohen's d=0.84||||||.056
91783853|NCT00826202|183448187|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Cohen's d=0.68||||||0.03
91783854|NCT00826202|183448188|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|cohen's d=0.93||||||0.12
91648932|NCT05166421|183190537|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.8633|1.0674||||||Statistical Comparison of AUClast of AZD8895||1.0674|0.8633|
91648933|NCT05166421|183190537|OTHER||Geometric mean ratio|1.0894|||||TWO_SIDED|90.0|0.9796|1.2116||||||Statistical Comparison of AUClast of AZD8895||1.2116|0.9796|
91648934|NCT05166421|183190537|OTHER||Geometric mean ratio|1.0065|||||TWO_SIDED|90.0|0.9061|1.118||||||Statistical Comparison of AUClast of AZD1061||1.1180|0.9061|
91648935|NCT05166421|183190537|OTHER||Geometric mean ratio|1.0293|||||TWO_SIDED|90.0|0.9257|1.1446||||||Statistical Comparison of AUClast of AZD1061||1.1446|0.9257|
91648936|NCT05166421|183190537|OTHER||Geometric mean ratio|1.0227|||||TWO_SIDED|90.0|0.9196|1.1373||||||Statistical Comparison of AUClast of AZD1061||1.1373|0.9196|
91648937|NCT05166421|183190538|OTHER||Geometric mean ratio|1.0308|||||TWO_SIDED|90.0|0.9451|1.1243||||||Statistical Comparison of Cmax of AZD7442||1.1243|0.9451|
91648938|NCT05166421|183190538|OTHER||Geometric mean ratio|0.993|||||TWO_SIDED|90.0|0.9112|1.0822||||||Statistical Comparison of Cmax of AZD7442||1.0822|0.9112|
91648939|NCT05166421|183190538|OTHER||Geometric mean ratio|0.9634|||||TWO_SIDED|90.0|0.8833|1.0507||||||Statistical Comparison of Cmax of AZD7442||1.0507|0.8833|
91648940|NCT05166421|183190538|OTHER||Geometric mean ratio|0.9701|||||TWO_SIDED|90.0|0.8894|1.0582||||||Statistical Comparison of Cmax of AZD8895||1.0582|0.8894|
91648941|NCT05166421|183190538|OTHER||Geometric mean ratio|0.9629|||||TWO_SIDED|90.0|0.8835|1.0494||||||Statistical Comparison of Cmax of AZD8895||1.0494|0.8835|
91648942|NCT05166421|183190538|OTHER||Geometric mean ratio|0.9926|||||TWO_SIDED|90.0|0.91|1.0826||||||Statistical Comparison of Cmax of AZD8895||1.0826|0.9100|
91648943|NCT05166421|183190538|OTHER||Geometric mean ratio|1.0976|||||TWO_SIDED|90.0|0.9992|1.2057||||||Statistical Comparison of Cmax of AZD1061||1.2057|0.9992|
91648944|NCT05166421|183190538|OTHER||Geometric mean ratio|1.0195|||||TWO_SIDED|90.0|0.929|1.119||||||Statistical Comparison of Cmax of AZD1061||1.1190|0.9290|
91783855|NCT00494676|183448245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||=|0.001|TWO_SIDED|95.0|1.8|21.0|||McNemar||The marginal odds ratio based on discordant pairs was computed.|The analysis used a McNemar test for data combined across both periods of the crossover. We estimated that 70% and 35% of participants would say yes to the real and sham prisms, respectively. For a 2-tailed test, the minimum sample size to detect a 35% difference in yes responses to real and sham prisms was 57 participants, assuming 30% overlap (30% said yes to both pairs of glasses), power of 90% and α of 1%. Assuming an attrition rate of 20%, we planned to enroll 68 participants.||21.0|1.8|= 0.001
91522101|NCT00406133|182919260|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.41
91595261|NCT00804570|183080807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.69|TWO_SIDED|95.0|-1.01|0.04||P-value is for desire to stop drinking at this time.|ANCOVA|||||0.04|-1.01|0.69
91595262|NCT00804570|183080807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.545|TWO_SIDED|95.0|-0.85|0.45||P-value is for expectation of success in quitting alcohol.|ANCOVA|||||0.45|-0.85|0.545
91595263|NCT00804570|183080807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.2|0.24||P-value is for difficulty to quit and remain abstinent.|ANCOVA|||||0.24|-1.20|0.190
91595264|NCT00804570|183080807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.856|TWO_SIDED|95.0|-0.49|0.4||P-value is for goal related to alcohol use.|ANCOVA|||||0.40|-0.49|0.856
91595265|NCT00804570|183080808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.297|TWO_SIDED|95.0|-0.68|2.22|||Mixed Models Analysis|||||2.22|-0.68|0.297
91595266|NCT00804570|183080809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46||||0.633|TWO_SIDED|95.0|-1.44|2.36|||Mixed Models Analysis|||||2.36|-1.44|0.633
91595267|NCT00804570|183080812|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.409|TWO_SIDED|95.0|-2.62|1.07||P-value is for supine systolic blood pressure.|Mixed Models Analysis|||||1.07|-2.62|0.409
91595268|NCT00804570|183080812|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45||||0.452|TWO_SIDED|95.0|-1.63|0.73||P-value is for supine diastolic blood pressure.|Mixed Models Analysis|||||0.73|-1.63|0.452
91595269|NCT00804570|183080813|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53||||0.456|TWO_SIDED|95.0|-1.93|0.87|||Mixed Models Analysis|||||0.87|-1.93|0.456
91595270|NCT00804570|183080814|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.08||||0.081|TWO_SIDED|95.0|-4.41|0.26|||Mixed Models Analysis|||||0.26|-4.41|0.081
91648945|NCT05166421|183190538|OTHER||Geometric mean ratio|0.9289|||||TWO_SIDED|90.0|0.8457|1.0203||||||Statistical Comparison of Cmax of AZD1061||1.0203|0.8457|
91709262|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|9.89||||0.09|TWO_SIDED|95.0|-1.57|21.35|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||21.35|-1.57|0.090
91595271|NCT00804570|183080815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
91595272|NCT00804570|183080816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Fisher Exact|||||||0.002
91595273|NCT00804570|183080817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69||||0.235|TWO_SIDED|95.0|-1.82|0.45||P-value is for orthostatic systolic blood pressure.|Mixed Models Analysis|||||0.45|-1.82|0.235
91595274|NCT00804570|183080817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.4|TWO_SIDED|95.0|-1.05|0.42||P-value is for orthostatic diastolic blood pressure.|Mixed Models Analysis|||||0.42|-1.05|0.400
91595275|NCT00804570|183080818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74||||0.077|TWO_SIDED|95.0|-0.08|1.57|||Mixed Models Analysis|||||1.57|-0.08|0.077
91595276|NCT00804570|183080820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.001|TWO_SIDED|95.0|0.24|0.9|||Mixed Models Analysis|||||0.90|0.24|<0.001
91595277|NCT00290342|183080821|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to diphteria||1.79|-1.85|
91595278|NCT00290342|183080821|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to tetanus||1.79|-1.85|
91595279|NCT00290342|183080822|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.82||||||Immune response non-inferiority - Anti-Polio 1||1.82|-1.85|
91709263|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.7||||0.908|TWO_SIDED|95.0|-11.19|12.59|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||12.59|-11.19|0.908
91595280|NCT00290342|183080822|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.49|||||TWO_SIDED|95.0|-1.36|2.71||||||Immune response non-inferiority - Anti-Polio 2||2.71|-1.36|
91595281|NCT00290342|183080822|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|-0.01|||||TWO_SIDED|95.0|-2.28|2.24||||||Immune response non-inferiority - Anti-Polio 3||2.24|-2.28|
91595282|NCT00290342|183080823|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|1.44|||||TWO_SIDED|95.0|-0.46|4.13||||||Immune response non-inferiority - Anti-PT||4.13|-0.46|
91595283|NCT00290342|183080823|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.45|||||TWO_SIDED|95.0|-1.88|2.95||||||Immune response non-inferiority - Anti-FHA||2.95|-1.88|
91595284|NCT00290342|183080823|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.47|||||TWO_SIDED|95.0|-1.4|2.64||||||Immune response non-inferiority - Anti-PRN||2.64|-1.4|
91595285|NCT00619255|183080836|SUPERIORITY||Slope|1.38||||0.71|TWO_SIDED||||||Chi-squared|DF=3||||||0.71
91595286|NCT00619255|183080837|SUPERIORITY||Slope|1.02||||0.8|TWO_SIDED||||||Chi-squared|DF=3||||||0.80
91595287|NCT00619255|183080838|SUPERIORITY|||||||0.67|||||||Chi-squared|"DF = 1~Chi-Square Value = 0.18"||||||0.67
91595288|NCT00619255|183080839|SUPERIORITY||Slope|9.0||||0.03|TWO_SIDED||||||Chi-squared|DF=3||||||0.03
91595289|NCT00619255|183080840|SUPERIORITY||Slope|1.35||||0.72|TWO_SIDED||||||Chi-squared|DF=3||||||0.72
91595290|NCT02121262|183080841|SUPERIORITY||Rate Difference|1.5||||0.7431|TWO_SIDED|95.0|-5.9|8.9|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel (CMH) general association test stratified by baseline BCVA categories.||||8.9|-5.9|0.7431
91709264|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.52||||0.013|TWO_SIDED|95.0|1.41|11.64|||Repeated measure model|||Baseline serum periostin \< 75th percentile||11.64|1.41|0.013
91709265|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.23||||0.635|TWO_SIDED|95.0|-3.84|6.29|||Repeated measure model|||Baseline serum periostin \< 75th percentile||6.29|-3.84|0.635
91595291|NCT02121262|183080842|SUPERIORITY||Least Squares Mean (LSM) Difference|2.9|STANDARD_ERROR_OF_MEAN|0.89||0.0011|TWO_SIDED|95.0|1.17|4.66|||ANCOVA|The ANCOVA model included the treatment group as the main effect and baseline BCVA score as the covariate.|Null hypothesis-there was no difference in treatment groups of average BCVA CFB in 12-months. Hypothesis test-based on 2-sided test at 0.05 significance level,confidence interval(CI) was constructed between treatment groups in LSM using ANCOVA model.|||4.66|1.17|0.0011
91595292|NCT02121262|183080843|SUPERIORITY||Least Squares Mean Difference|-89.3|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|-122.53|-56.01|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline retinal thickness as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-56.01|-122.53|<0.0001
91595293|NCT02121262|183080844|SUPERIORITY||Least Squares Mean Difference|-7.729|STANDARD_ERROR_OF_MEAN|1.0443|<|0.0001|TWO_SIDED|95.0|-9.7855|-5.6733|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline total leakage area as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-5.6733|-9.7855|<0.0001
91595294|NCT01553188|183080845|SUPERIORITY|||||||0.44|||||||Log rank two-tailed p-value|||||||0.44
91595295|NCT01553188|183080847|SUPERIORITY|||||||0.26|||||||Log rank two-tailed p-value|||||||0.26
91595296|NCT05376215|183080909|NON_INFERIORITY|The non-inferiority margin of -12.5 was used per the findings from Chisolm, et al (2005), see attached article. In that study, the smallest critical difference for the short term retest difference was 12.5 for the APHAB global score at the 90th percentile. For this study, non-inferiority is confirmed if Fitting Method B is no more than 12.5 percentage points below the mean global benefit score of Fitting Method A.||||||0.806|||||||Mixed Models Analysis|||||||0.806
91595297|NCT05376215|183080910|NON_INFERIORITY|The non-inferiority margin is -1.8 dB. This is based off of work by Killion (2004) in which the critical difference for 4 lists is 1.9 dB at the 95% confidence interval. Killion also found that if all 12 lists are presented, the mean SNR scores will differ by 1.8 dB 5% of the time.||||||0.889|||||||Mixed Models Analysis|||||||0.889
91709266|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.89||||0.014|TWO_SIDED|95.0|1.84|15.94|||Repeated measure model|||Th2 high||15.94|1.84|0.014
91595298|NCT01301950|183080911|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.||||0.54
91595299|NCT02651584|183080916|NON_INFERIORITY|The p-value was based on the chi square test for non-inferiority with the margin of 10% point.|||||<|0.001|||||||Chi-squared|||||||<0.001
91595300|NCT02651584|183080917|SUPERIORITY|||||||0.004|||||||Wilcoxon Rank-Sum|||including subject self-reported opioid use||||0.004
91595301|NCT02651584|183080917|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum|||not including self-reported opioid use||||0.008
91595302|NCT02651584|183080919|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was based on the chi square test for non-inferiority with the margin of 15%.||||||0.006|||||||Chi-squared|||||||0.006
91595303|NCT00942175|183080920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.6106|0.8026|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8026|0.6106|
91595304|NCT00942175|183080920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.734|||||TWO_SIDED|90.0|0.6516|0.8269|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8269|0.6516|
91595305|NCT00942175|183080920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5564|||||TWO_SIDED|90.0|0.4877|0.6347|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.6347|0.4877|
91595306|NCT00942175|183080920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6783|||||TWO_SIDED|90.0|0.5063|0.9087|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9087|0.5063|
91595307|NCT00942175|183080921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8573|||||TWO_SIDED|90.0|0.802|0.9165|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9165|0.8020|
91595308|NCT00942175|183080921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9103|||||TWO_SIDED|90.0|0.8567|0.9672|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9672|0.8567|
91595309|NCT00942175|183080921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6943|||||TWO_SIDED|90.0|0.6438|0.7487|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.7487|0.6438|
91595310|NCT00942175|183080921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8389|||||TWO_SIDED|90.0|0.644|1.0928|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||1.0928|0.6440|
91595311|NCT00942175|183080922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1016|||||TWO_SIDED|90.0|0.0348|8.1684|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||8.1684|0.0348|
91595312|NCT00942175|183080922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0474|||||TWO_SIDED|90.0|-0.8555|4.9503|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||4.9503|-0.8555|
91595313|NCT00942175|183080922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0407|||||TWO_SIDED|90.0|6.5219|15.5595|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.5595|6.5219|
91595314|NCT00942175|183080922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4437|||||TWO_SIDED|90.0|7.1791|15.7083|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.7083|7.1791|
91595315|NCT00942175|183080923|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.035
91595316|NCT00942175|183080923|SUPERIORITY_OR_OTHER|||||||0.445||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.445
91595317|NCT00942175|183080923|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
91595318|NCT00942175|183080923|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
91595319|NCT00942175|183080924|SUPERIORITY_OR_OTHER|||||||0.004||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.004
91595320|NCT00942175|183080924|SUPERIORITY_OR_OTHER|||||||0.148||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.148
91595321|NCT00942175|183080924|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
91595322|NCT00942175|183080924|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<.0001
91595323|NCT00578136|183080956|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|The Wilcoxon rank-sum test was used because the study did not have a normal distribution using the Kolmogorov-Smirnov test (p\<0.01).||Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.||||0.008
91595324|NCT02822885|183081013|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91595325|NCT02822885|183081014|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91595326|NCT02822885|183081015|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91595327|NCT02822885|183081016|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91595328|NCT02822885|183081017|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91595329|NCT04013529|183081047|SUPERIORITY||||||=|0.9|||||||ANCOVA|||||||=0.90
91595330|NCT04013529|183081048|SUPERIORITY||||||=|0.88|||||||ANCOVA|||||||= 0.88
91595331|NCT04013529|183081049|SUPERIORITY||||||<|0.17|||||||ANCOVA|||||||< 0.17
91595332|NCT04013529|183081050|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||< 0.05
91595333|NCT04013529|183081051|SUPERIORITY||||||=|0.81|||||||ANCOVA|||||||= 0.81
91595334|NCT02971631|183081072|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Paired analysis||||||0.008
91595335|NCT02971631|183081073|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired analysis||||||0.03
91595336|NCT02971631|183081074|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|Paired analysis||For meal consumption rate||||0.79
91595337|NCT02971631|183081076|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Baseline||||0.20
91595338|NCT02971631|183081076|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Paired analysis||Post-OGTT||||0.58
91595339|NCT02971631|183081076|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.39
91595340|NCT02971631|183081076|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.20
91595341|NCT02971631|183081077|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|Paired analysis||Baseline||||0.26
91595342|NCT02971631|183081077|SUPERIORITY|||||||0.06||||||Paired analysis|t-test, 2 sided|||Post-OGTT||||0.06
91595343|NCT02971631|183081077|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.95
91595344|NCT02971631|183081077|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.88
91595345|NCT02971631|183081078|SUPERIORITY|||||||1|||||||Other|0 events over whole study, no statistical test appropriate||||||1
91595346|NCT02971631|183081079|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91595347|NCT05885737|183081080|EQUIVALENCE|Testing of primary efficacy endpoint was 2-sided and conducted at the 5% significance level. The efficacy of difelikefalin was to be declared for this study if null hypothesis of no treatment difference in the primary efficacy analysis was rejected in favor of the alternative that participants randomized to difelikefalin experience significantly different itching compared to participants randomized to placebo. The null hypothesis was to be rejected if the 2-sided p value was less than (\<) 0.05.|Least square mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.223||0.0003|TWO_SIDED|95.0|-1.25|-0.37|||MMRM|||The null hypothesis in this study was that there was no treatment difference in the primary efficacy analysis of the primary endpoint. The alternative hypothesis was that in participants randomized to difelikefalin there was a significant treatment difference in change in itching compared to participants randomized to placebo. The assessment was based on the mean change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the DB period.||-0.37|-1.25|0.0003
91595348|NCT00609791|183081092|SUPERIORITY||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.0057||0.055|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on age in years||||0.055
91595349|NCT00609791|183081092|SUPERIORITY||Slope|1.17|STANDARD_ERROR_OF_MEAN|0.45||0.013|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on chemotherapy toxicity risk score||||0.013
91595350|NCT00609791|183081093|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0063||0.25|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL on age in years||||0.25
91595351|NCT00609791|183081093|SUPERIORITY||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.44||0.04|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL versus chemotherapy toxicity risk score||||0.04
91595352|NCT00609791|183081094|OTHER|||||||0.041|||||||Fisher Exact|||||||0.041
91595353|NCT00609791|183081097|SUPERIORITY||Mean Difference (Final Values)|-4.89||||0.38|TWO_SIDED|95.0|-16.5|6.7|||t-test, 2 sided|||Difference in age based on whether there was need for a dose reduction.||6.7|-16.5|.38
91648946|NCT03877237|183190561|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.23||||0.02164|TWO_SIDED|95.0|0.96|8.22||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.22|0.96|0.02164
91783856|NCT00494676|183448246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|2.6|=|0.09|TWO_SIDED|95.0|-0.1|1.3|||t-test, 2 sided|||Mobility improvement scores were normally distributed. A paired t-test was used to conduct a within-subjects comparison of the crossover differences in mobility scores between real and sham prism glasses. An alpha level of 5% was used to indicate statistical significance for secondary analyses||1.3|-0.1|= 0.09
91783857|NCT00494676|183448247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.7|=|0.002|TWO_SIDED|95.0|0.7|3.0|||t-test, 2 sided|||||3.0|0.7|= 0.002
91783858|NCT00494676|183448248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|2.1|=|0.21|TWO_SIDED|95.0|-1.2|0.3|||t-test, 2 sided|||||0.3|-1.2|= 0.21
91783859|NCT04976192|183448249|OTHER||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-1.56|0.94||||||||0.94|-1.56|
91783860|NCT04976192|183448250|OTHER||LS Mean Difference|-0.39|||||TWO_SIDED|90.0|-1.37|0.58||||||||0.58|-1.37|
91783861|NCT04976192|183448250|OTHER||Relative Potency|0.89|||||||||||||Relative potency of TEV-45779 and XOLAIR is a co-primary efficacy endpoint for FDA submission.|The relative potency of the test drug to the reference drug was defined as the dose of the test drug that produced the same biological response as 1 unit of the dose of the reference drug. Relative potency was demonstrated if the 90% confidence interval (CI) for relative potency fell entirely within the equivalence margins.||||
91783862|NCT04073225|183448277|SUPERIORITY||Mean Difference (Net)|-33.8||||0.323|TWO_SIDED|95.0|-100.9|33.2|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||33.2|-100.9|.323
91783863|NCT04073225|183448278|SUPERIORITY||Mean Difference (Net)|-81.3||||0.057|TWO_SIDED|95.0|-165.2|2.5|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||2.5|-165.2|.057
91783864|NCT04073225|183448279|SUPERIORITY||Mean Difference (Net)|3.1||||0.047|TWO_SIDED|95.0|0.03|6.08|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||6.08|0.03|.047
91783865|NCT04073225|183448280|SUPERIORITY||Mean Difference (Net)|0.59||||0.565|TWO_SIDED|95.0|-1.4|2.6|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||2.6|-1.4|.565
91783866|NCT04073225|183448281|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.825||0.147|TWO_SIDED|95.0|-0.5|3.03|||t-test, 2 sided|||||3.03|-0.50|0.147
91783867|NCT04073225|183448282|SUPERIORITY||Mean Difference (Net)|99.4||||0.605|TWO_SIDED|95.0|-334.3|533.0|||t-test, 2 sided|||We conducted t-tests of differences in volumetric change comparing intervention to control arms.||533.0|-334.3|.605
91783868|NCT04073225|183448283|SUPERIORITY||Mean Difference (Net)|130.8||||0.59|TWO_SIDED|95.0|-259.7|248.6|||t-test, 2 sided|||We conducted t-tests of differences in volumetric change comparing intervention to control arms.||248.6|-259.7|.590
91783869|NCT04073225|183448284|SUPERIORITY||Mean Difference (Net)|-24.72|STANDARD_ERROR_OF_MEAN|73.85||0.743|TWO_SIDED|95.0|-183.11|133.68|||t-test, 2 sided|||||133.68|-183.11|.743
91783870|NCT04073225|183448285|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|3.13||0.731|TWO_SIDED|95.0|-7.91|5.71|||t-test, 2 sided|||||5.71|-7.91|0.731
91790415|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.187||0.491|TWO_SIDED|95.0|-0.238|0.496||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.496|-0.238|0.491
91790416|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91648947|NCT03877237|183190562|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.17||||0.05842|TWO_SIDED|95.0|0.03|8.33||KCCQ-PLS was tested at the alpha level of 0.04990 because KCCQ-TSS had a statistically significant p-value, in accordance with the pre-specified testing strategy.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.33|0.03|0.05842
91595354|NCT00609791|183081097|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.76|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided|||Difference in AUC24 based on the need of a dose reduction.||0.44|-0.33|0.76
91595355|NCT00609791|183081097|SUPERIORITY||Mean Difference (Final Values)|-0.063||||0.75|TWO_SIDED|95.0|-0.49|0.36|||t-test, 2 sided|||Difference in clearance based on whether there was a need for dose reduction.||0.36|-0.49|0.75
91595356|NCT00609791|183081098|SUPERIORITY||Mean Difference (Final Values)|5.81||||0.15|TWO_SIDED|95.0|-2.3|13.9|||t-test, 2 sided|||Difference in age based on whether there was need for a dose omission.||13.9|-2.3|0.15
91595357|NCT00609791|183081098|SUPERIORITY||Mean Difference (Final Values)|-0.079||||0.61|TWO_SIDED|95.0|-0.39|0.23|||t-test, 2 sided|||Difference in AUC24 based on whether there was need for a dose omission.||0.23|-0.39|0.61
91595358|NCT00609791|183081098|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|95.0|-0.22|0.42|||t-test, 2 sided|||Difference in clearance based on whether there was a need for a dose omission.||0.42|-0.22|0.51
91595359|NCT00609791|183081099|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.75|TWO_SIDED|95.0|-9.3|12.7|||t-test, 2 sided|||Difference in age based on whether a participant experienced grade 3 toxicity.||12.7|-9.3|0.75
91648948|NCT03877237|183190563|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.2||||0.68626|TWO_SIDED|95.0|-6.5|13.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00010:~H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||13.0|-6.5|0.68626
91709267|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.91||||0.28|TWO_SIDED|95.0|-3.19|11.02|||Repeated measure model|||Th2 high||11.02|-3.19|0.280
91709268|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.22||||0.292|TWO_SIDED|95.0|-2.78|9.22|||Repeated measure model|||Th2 low||9.22|-2.78|0.292
91595360|NCT00609791|183081099|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.13|TWO_SIDED|95.0|-0.12|0.81|||t-test, 2 sided|||Difference in AUC based on whether a participant experienced grade 3 toxicity.||0.81|-0.12|0.13
91595361|NCT00609791|183081099|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.34|TWO_SIDED|95.0|-0.67|0.25|||t-test, 2 sided|||Difference in clearance based on whether a participant experienced grade 3 toxicity.||0.25|-0.67|0.34
91595362|NCT04129528|183081102|SUPERIORITY||Ratio of geometric means CFZ533/placebo|1.173||||0.1817|TWO_SIDED|80.0|0.94|1.47||one-sided P-value|Mixed model repeated measure analysis|||||1.47|0.94|0.1817
91595363|NCT02933034|183081128|OTHER|||||||0.001|||||||t-test, 2 sided|||Comparison of infarct size using MEMRI versus DEMRI scan||||0.001
91595364|NCT01146873|183081182|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|0.107|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
91595365|NCT01146873|183081183|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|-0.007|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
91595366|NCT01146873|183081184|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91595367|NCT01146873|183081186|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
91595368|NCT01399788|183081240|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.81|||||TWO_SIDED|90.0|99.2|108.64||||||Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||108.64|99.20|
91595369|NCT01399788|183081240|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|107.28|||||TWO_SIDED|90.0|101.95|112.9||||||Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||112.90|101.95|
91595370|NCT01399788|183081240|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
91595371|NCT01399788|183081241|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|102.75|||||TWO_SIDED|90.0|95.36|110.71||||||Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||110.71|95.36|
91595372|NCT01399788|183081241|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.85|||||TWO_SIDED|90.0|92.13|117.07||||||Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||117.07|92.13|
91595373|NCT01399788|183081241|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
91595374|NCT01399788|183081242|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.73|||||TWO_SIDED|90.0|99.12|104.4||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.40|99.12|
91595375|NCT01399788|183081243|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|95.17|||||TWO_SIDED|90.0|88.6|102.22||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.22|88.60|
91648949|NCT03877237|183190564|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|-0.16||||0.19748|TWO_SIDED|95.0|-0.55|0.22||Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||0.22|-0.55|0.19748
91648950|NCT02290028|183190574|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.||||<0.0001
91783871|NCT05407064|183448286|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 4 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 4 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 4 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
91648951|NCT02290028|183190575|SUPERIORITY||||||=|0.002|||||||Exact, binomial|||Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.||||=0.002
91595376|NCT01399788|183081244|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.3|||||TWO_SIDED|90.0|99.7|109.1||||||Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||109.10|99.70|
91595377|NCT01399788|183081244|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|105.74|||||TWO_SIDED|90.0|100.32|111.46||||||Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||111.46|100.32|
91595378|NCT01399788|183081244|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|100.97|||||TWO_SIDED|90.0|96.28|105.88||||||Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||105.88|96.28|
91595379|NCT01399788|183081245|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.8|||||TWO_SIDED|90.0|99.24|104.43||||||Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.43|99.24|
91595380|NCT02919436|183081248|SUPERIORITY|We found observed rate of postoperative urinary retention in male spine surgery patients to historically be 17%. We hypothesize that the use of tamsulosin can reduce this rate by 50%. A two group continuity corrected chi-square test with a .05 two-sided significance level will have 80% power to detect the difference between a control group proportion of .17 and a treatment group proportion of .085 (odds ratio of .454) when the sample size in each group is 264 and a total sample size of 528.||||||0.96|||||||Chi-squared, Corrected|||||||.96
91595381|NCT01389752|183081251|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.65|||||TWO_SIDED|90.0|0.61|0.68||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.68|0.61|
91595382|NCT01389752|183081252|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.9|||||TWO_SIDED|90.0|0.83|0.98||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.98|0.83|
91595383|NCT01389752|183081253|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.55||||0.001|TWO_SIDED|90.0|-1.04|-0.5||The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).|Wilcoxon (Mann-Whitney)|||||-0.50|-1.04|0.0010
91709269|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.18||||0.691|TWO_SIDED|95.0|-6.99|4.64|||Repeated measure model|||Th2 low||4.64|-6.99|0.691
91595384|NCT01594515|183081260|SUPERIORITY_OR_OTHER||Slope|0.9702|STANDARD_ERROR_OF_MEAN|0.0151|||TWO_SIDED|95.0|0.94|1.0005|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50)||1.0005|0.9400|
91709270|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.83||||0.004|TWO_SIDED|95.0|2.85|14.81|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||14.81|2.85|0.004
91709271|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.25||||0.177|TWO_SIDED|95.0|-1.92|10.43|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||10.43|-1.92|0.177
91595385|NCT01594515|183081261|SUPERIORITY_OR_OTHER||Slope|1.0442|STANDARD_ERROR_OF_MEAN|0.0148|||TWO_SIDED|95.0|1.0145|1.074|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale."|This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48)||1.0740|1.0145|
91595386|NCT02409290|183081273|SUPERIORITY||Cox Proportional Hazard|0.2||||0.0016|TWO_SIDED|95.0|0.07|0.61|||Log Rank|||||0.61|0.07|0.0016
91595387|NCT02409290|183081274|SUPERIORITY||Cox Proportional Hazard|0.11||||0.0005|TWO_SIDED|95.0|0.03|0.5|||Log Rank|||Control regimen (arm B) uses concurrent controls only||0.50|0.03|0.0005
91595388|NCT04251910|183081280|SUPERIORITY|||||||0.0813|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0813
91595389|NCT04251910|183081280|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0011
91595390|NCT04251910|183081280|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0002
91595391|NCT04251910|183081282|SUPERIORITY|||||||0.9616|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.9616
91709272|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.05||||0.159|TWO_SIDED|95.0|-2.39|14.5|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||14.50|-2.39|0.159
91709273|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.72||||0.857|TWO_SIDED|95.0|-8.63|7.18|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||7.18|-8.63|0.857
91783872|NCT05407064|183448287|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 8 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 8 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
91783873|NCT05407064|183448288|SUPERIORITY|||||||0.1157|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1157
91783874|NCT05407064|183448288|SUPERIORITY|||||||0.663|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.6630
91783875|NCT05407064|183448288|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0004
91783876|NCT05407064|183448288|SUPERIORITY|||||||0.01|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0100
91783877|NCT05407064|183448289|SUPERIORITY|||||||0.2309|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2309
91783878|NCT05407064|183448289|SUPERIORITY|||||||0.7218|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.7218
91783879|NCT05407064|183448289|SUPERIORITY|||||||0.0637|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0637
91783880|NCT05407064|183448289|SUPERIORITY|||||||0.0216|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0216
91595392|NCT04251910|183081282|SUPERIORITY|||||||0.546|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.5460
91595393|NCT04251910|183081282|SUPERIORITY|||||||0.0961|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/s Part A-Placebo (2 hours)||||0.0961
91595394|NCT04251910|183081282|SUPERIORITY|||||||0.1359|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.1359
91595395|NCT04251910|183081282|SUPERIORITY|||||||0.1688|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.1688
91595396|NCT04251910|183081282|SUPERIORITY|||||||0.667|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.6670
91595397|NCT04251910|183081282|SUPERIORITY|||||||0.8695|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.8695
91595398|NCT04251910|183081282|SUPERIORITY|||||||0.5002|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.5002
91595399|NCT04251910|183081282|SUPERIORITY|||||||0.5631|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.5631
91595400|NCT04251910|183081282|SUPERIORITY|||||||0.0089|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (1 hour)||||0.0089
91595401|NCT04251910|183081282|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (2 hours)||||<.0001
91595402|NCT04251910|183081282|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.0011
91595403|NCT04251910|183081282|SUPERIORITY|||||||0.0008|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.0008
91595404|NCT04251910|183081282|SUPERIORITY|||||||0.2847|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.2847
91595405|NCT04251910|183081282|SUPERIORITY|||||||0.2616|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.2616
91595406|NCT04251910|183081282|SUPERIORITY|||||||0.1989|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.1989
91595407|NCT04251910|183081282|SUPERIORITY|||||||0.4585|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (30 minutes)||||0.4585
91595408|NCT04251910|183081282|SUPERIORITY|||||||0.0005|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (1 hour)||||0.0005
91595409|NCT04251910|183081282|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0004
91595410|NCT04251910|183081282|SUPERIORITY|||||||0.0025|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (4 hours)||||0.0025
91595411|NCT04251910|183081282|SUPERIORITY|||||||0.1027|TWO_SIDED|95.0|||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (8 hours)||||0.1027
91595412|NCT04251910|183081282|SUPERIORITY|||||||0.7953|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (24 hours)||||0.7953
91595413|NCT04251910|183081282|SUPERIORITY|||||||0.1416|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.1416
91595414|NCT04251910|183081282|SUPERIORITY|||||||0.0658|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.0658
91595415|NCT04251910|183081283|SUPERIORITY|||||||0.876|||||||Mixed effects model|||Part A -30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.8760
91648952|NCT02290028|183190576|SUPERIORITY|||||||||||||||||Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%|On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
91648953|NCT01735877|183190587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.52||0.77|||||||t-test, 2 sided|||At Baseline||||0.77
91648954|NCT01735877|183190587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12|||<|0.0001|TWO_SIDED|95.0|11.02|17.25|||ANCOVA|||Mean Change from baseline to 1 month||17.25|11.02|<0.0001
91648955|NCT01735877|183190587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.56|||<|0.0001|TWO_SIDED|95.0|18.65|26.48|||ANCOVA|||Baseline to 3 month||26.48|18.65|<0.0001
91648956|NCT01735877|183190587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.28|||<|0.0001|TWO_SIDED|95.0|18.94|27.62|||ANCOVA|||Baseline to 6 month||27.62|18.94|<0.0001
91648957|NCT01735877|183190588|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
91783881|NCT05407064|183448290|SUPERIORITY|||||||0.1006|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1006
91783882|NCT05407064|183448290|SUPERIORITY|||||||0.2225|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2225
91783883|NCT05407064|183448290|SUPERIORITY|||||||0.0025|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0025
91595416|NCT04251910|183081283|SUPERIORITY|||||||0.9077|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (Day 1; 2 hours)||||0.9077
91595417|NCT04251910|183081283|SUPERIORITY|||||||0.7208|||||||Mixed effects model|||Part A 30 mcg BXCL501 vs Part A-Placebo (Day1; 4 hours)||||0.7208
91595418|NCT04251910|183081283|SUPERIORITY|||||||0.3666|||||||Mixed effects model|||Part A BXCL501 30 mcg v/s Part A-Placebo(Day 1;8 hours)||||0.3666
91595419|NCT04251910|183081283|SUPERIORITY|||||||0.0191|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Placebo-Part A (Day1; 1 hour)||||0.0191
91595420|NCT04251910|183081283|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Part A-Placebo (Day 1; 2 hours)||||0.0006
91595421|NCT04251910|183081283|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 1; 4 hours)||||<.0001
91595422|NCT04251910|183081283|SUPERIORITY|||||||0.0003|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1;8 hours)||||0.0003
91595423|NCT04251910|183081283|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0006
91595424|NCT04251910|183081283|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0002
91595425|NCT04251910|183081283|SUPERIORITY|||||||0.0029|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0029
91595426|NCT04251910|183081283|SUPERIORITY|||||||0.2446|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.2446
91595427|NCT04251910|183081284|SUPERIORITY|||||||0.0926|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.0926
91595428|NCT04251910|183081284|SUPERIORITY|||||||0.3976|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.3976
91595429|NCT04251910|183081284|SUPERIORITY|||||||0.1169|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1169
91595430|NCT04251910|183081284|SUPERIORITY|||||||0.3786|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.3786
91595431|NCT04251910|183081284|SUPERIORITY|||||||0.564|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24hours)||||0.5640
91595432|NCT04251910|183081284|SUPERIORITY|||||||0.602|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.6020
91595433|NCT04251910|183081284|SUPERIORITY|||||||0.5875|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5875
91595434|NCT04251910|183081284|SUPERIORITY|||||||0.1055|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.1055
91648958|NCT01735877|183190588|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At 1 month||||0.99
91648959|NCT01735877|183190588|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||At 3 months||||0.03
91783884|NCT05407064|183448290|SUPERIORITY|||||||0.0042|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0042
91783885|NCT05407064|183448291|SUPERIORITY|||||||0.6258|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6258
91595435|NCT04251910|183081284|SUPERIORITY|||||||0.0024|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0024
91783886|NCT05407064|183448291|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.95
91783887|NCT05407064|183448291|SUPERIORITY|||||||0.0174|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0174
91783888|NCT05407064|183448291|SUPERIORITY|||||||0.0206|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0206
91783889|NCT05407064|183448292|SUPERIORITY|||||||0.5538|||||||t-test, 2 sided|||Assessment of change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.5538
91783890|NCT05407064|183448292|SUPERIORITY|||||||0.665|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6650
91783891|NCT05407064|183448292|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0190
91783892|NCT05407064|183448292|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0034
91783893|NCT05407064|183448293|SUPERIORITY|||||||0.7236|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.7236
91783894|NCT05407064|183448293|SUPERIORITY|||||||0.9738|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.9738
91783895|NCT05407064|183448293|SUPERIORITY|||||||0.0338|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0338
91783896|NCT05407064|183448293|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0282
91783897|NCT05407064|183448294|SUPERIORITY|||||||0.9302|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.9302
91783898|NCT05407064|183448294|SUPERIORITY|||||||0.6763|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.6763
91783899|NCT05407064|183448294|SUPERIORITY|||||||0.0816|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0816
91783900|NCT05407064|183448294|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0190
91783901|NCT05407064|183448295|SUPERIORITY|||||||0.5647|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.5647
91783902|NCT05407064|183448295|SUPERIORITY|||||||0.3497|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3497
91783903|NCT05407064|183448295|SUPERIORITY|||||||0.0229|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0229
91783904|NCT05407064|183448295|SUPERIORITY|||||||0.0073|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0073
91783905|NCT05407064|183448296|SUPERIORITY|||||||0.0158|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0158
91595436|NCT04251910|183081284|SUPERIORITY|||||||0.0016|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0016
91783906|NCT05407064|183448296|SUPERIORITY|||||||0.0429|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0429
91783907|NCT05407064|183448296|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
91783908|NCT05407064|183448296|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
91783909|NCT05407064|183448297|SUPERIORITY|||||||0.0804|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0804
91783910|NCT05407064|183448297|SUPERIORITY|||||||0.0532|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0532
91783911|NCT05407064|183448297|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
91783912|NCT05407064|183448297|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
91595437|NCT04251910|183081284|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0002
91595438|NCT04251910|183081284|SUPERIORITY|||||||0.2039|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.2039
91595439|NCT04251910|183081284|SUPERIORITY|||||||0.1948|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.1948
91595440|NCT04251910|183081284|SUPERIORITY|||||||0.5615|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5615
91595441|NCT04251910|183081284|SUPERIORITY|||||||0.8266|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.8266
91595442|NCT04251910|183081284|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
91648960|NCT01735877|183190588|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||At 6 months||||0.004
91648961|NCT01735877|183190589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.25||0.64|||||||t-test, 2 sided|||At Baseline||||0.64
91648962|NCT01735877|183190589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.92||||0.002|TWO_SIDED|95.0|2.24|9.6|||ANCOVA|||Mean change from baseline to 1 month||9.60|2.24|0.002
91783913|NCT05407064|183448298|SUPERIORITY|||||||0.2152|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.2152
91783914|NCT05407064|183448298|SUPERIORITY|||||||0.3369|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3369
91783915|NCT05407064|183448298|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0010
91783916|NCT05407064|183448298|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0046
91783917|NCT05407064|183448299|SUPERIORITY|||||||0.4489|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.4489
91783918|NCT05407064|183448299|SUPERIORITY|||||||0.7326|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.7326
91783919|NCT05407064|183448299|SUPERIORITY|||||||0.0492|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0492
91783920|NCT05407064|183448299|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0131
91783921|NCT05407064|183448300|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3330
91783922|NCT05407064|183448300|SUPERIORITY|||||||0.1193|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.1193
91783923|NCT05407064|183448300|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0032
91783924|NCT05407064|183448300|SUPERIORITY|||||||0.0127|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0127
91595443|NCT04251910|183081284|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0004
91595444|NCT04251910|183081284|SUPERIORITY|||||||0.1037|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.1037
91595445|NCT04251910|183081284|SUPERIORITY|||||||0.3267|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.3267
91595446|NCT04251910|183081284|SUPERIORITY|||||||0.0339|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.0339
91595447|NCT04251910|183081284|SUPERIORITY|||||||0.1892|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day7)||||0.1892
91595448|NCT04251910|183081285|SUPERIORITY|||||||0.3359|||||||Fisher Exact|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.3359
91595449|NCT04251910|183081285|SUPERIORITY|||||||0.0004|||||||Fisher Exact|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.0004
91595450|NCT04251910|183081285|SUPERIORITY|||||||0.0351|||||||Fisher Exact|||||||0.0351
91595451|NCT04251910|183081286|SUPERIORITY|||||||0.0952|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0952
91595452|NCT04251910|183081286|SUPERIORITY|||||||0.8977|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.8977
91595453|NCT04251910|183081286|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0002
91595454|NCT04251910|183081286|SUPERIORITY|||||||0.3147|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.3147
91595455|NCT04251910|183081286|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||<.0001
91595456|NCT04251910|183081286|SUPERIORITY|||||||0.1241|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.1241
91595457|NCT04251910|183081287|SUPERIORITY|||||||0.408|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.4080
91648963|NCT01735877|183190589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71||||0.005|TWO_SIDED|95.0|2.8|14.63|||ANCOVA|||Mean change from baseline to 3 month||14.63|2.80|0.005
91648964|NCT01735877|183190589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.63||||0.006|TWO_SIDED|95.0|2.67|14.6|||ANCOVA|||Mean change from baseline to 6 month||14.60|2.67|0.006
91595458|NCT04251910|183081287|SUPERIORITY|||||||0.4198|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.4198
91595459|NCT04251910|183081287|SUPERIORITY|||||||0.037|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day1; 2 hours)||||0.0370
91595460|NCT04251910|183081287|SUPERIORITY|||||||0.1324|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1324
91595461|NCT04251910|183081287|SUPERIORITY|||||||0.0624|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0624
91595462|NCT04251910|183081287|SUPERIORITY|||||||0.6334|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.6334
91595463|NCT04251910|183081287|SUPERIORITY|||||||0.0275|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0275
91648965|NCT01735877|183190590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.24||0.99|||||||t-test, 2 sided|||Baseline||||0.99
91648966|NCT01735877|183190590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.0001|TWO_SIDED|95.0|2.93|4.42|||ANCOVA|||Mean change from baseline to 1 month||4.42|2.93|<0.0001
91648967|NCT01735877|183190590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.0001|TWO_SIDED|95.0|2.61|4.21|||ANCOVA|||Mean change from baseline to 3 month||4.21|2.61|<0.0001
91595464|NCT04251910|183081287|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
91648968|NCT01735877|183190590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.4|4.02|||ANCOVA|||Mean change from baseline to 6 month||4.02|2.40|<0.0001
91595465|NCT04251910|183081287|SUPERIORITY|||||||0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0001
91595466|NCT04251910|183081287|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day1; 8 hours)||||<.0001
91595467|NCT04251910|183081287|SUPERIORITY|||||||0.2806|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.2806
91595468|NCT04251910|183081287|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
91595469|NCT04251910|183081287|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hour)||||<.0001
91595470|NCT04251910|183081287|SUPERIORITY|||||||0.0009|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0009
91595471|NCT04251910|183081287|SUPERIORITY|||||||0.0081|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.0081
91595472|NCT04251910|183081288|SUPERIORITY|||||||0.0591|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0591
91595473|NCT04251910|183081288|SUPERIORITY|||||||0.0966|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0966
91595474|NCT04251910|183081288|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
91595475|NCT04251910|183081288|SUPERIORITY|||||||0.029|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0290
91595476|NCT04251910|183081288|SUPERIORITY|||||||0.0937|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0937
91595477|NCT04251910|183081288|SUPERIORITY|||||||0.2747|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.2747
91595478|NCT04251910|183081291|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours post administration)||||0.0002
91595479|NCT01056510|183081293|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||The first-line subpopulation became the focus of the primary statistical analysis following the protocol amendment dated 21-May-2012.||||0.002
91595480|NCT01056510|183081294|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||< 0.001
91595481|NCT01056510|183081295|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||0.009
91595482|NCT01056510|183081296|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 3 cycles||||0.900
91648969|NCT01735877|183190591|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
91648970|NCT01735877|183190591|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At month 1||||0.99
91648971|NCT01735877|183190591|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||At month 3||||0.04
91595483|NCT01056510|183081296|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 6 cycles||||0.563
91595484|NCT01056510|183081296|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||At the EOT visit||||0.304
91595485|NCT01056510|183081299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.525||||0.003|TWO_SIDED|95.0|0.341|0.809|||Log Rank|||Unstratified analysis||0.809|0.341|0.003
91595486|NCT01056510|183081299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.523||||0.003|TWO_SIDED|95.0|0.339|0.806|||Log Rank|||Stratified analysis: by baseline Binet stage||0.806|0.339|0.003
91595487|NCT01056510|183081301|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Log Rank|||||||0.029
91595488|NCT01056510|183081303|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Log Rank|||||||0.006
91648972|NCT01735877|183190591|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||At month 6||||0.01
91648973|NCT04364165|183190613|SUPERIORITY||Odds Ratio (OR)|2.0||||0.01|TWO_SIDED|95.0|1.44|2.78|||Regression, Logistic|||||2.78|1.44|.01
91648974|NCT04364165|183190614|SUPERIORITY||Odds Ratio (OR)|1.44||||0.41|TWO_SIDED|95.0|0.36|5.78|||Regression, Logistic|||||5.78|0.36|.41
91595489|NCT01056510|183081305|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Log Rank|||||||0.037
91595490|NCT01056510|183081307|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Log Rank|||||||0.007
91595491|NCT01056510|183081309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994||||0.986|TWO_SIDED|95.0|0.517|1.911||Unstratified analysis|Log Rank|||||1.911|0.517|0.986
91648975|NCT00830063|183190615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.76|-0.72||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.||-0.72|-1.76|<0.001
91595492|NCT01056510|183081309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.939|TWO_SIDED|95.0|0.505|1.88|||Log Rank|||Stratified analysis: by baseline Binet stage||1.880|0.505|0.939
91595493|NCT01056510|183081310|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||||||< 0.001
91595494|NCT01765920|183081361|SUPERIORITY|||||||0.0174||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0174
91595495|NCT01765920|183081362|SUPERIORITY|||||||0.0719||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0719
91595496|NCT01765920|183081363|SUPERIORITY|||||||0.02||||||Total score analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.02
91595497|NCT01765920|183081363|SUPERIORITY|||||||0.0099||||||"Symptoms domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.0099
91595498|NCT01765920|183081363|SUPERIORITY|||||||0.037||||||"Ability domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.037
91595499|NCT01765920|183081364|SUPERIORITY|||||||0.22||||||Day 1 analysis.|Fisher Exact|||||||0.22
91595500|NCT01765920|183081364|SUPERIORITY|||||||0.32||||||Day 2 analysis.|Fisher Exact|||||||0.32
91595501|NCT01765920|183081364|SUPERIORITY|||||||0.47||||||Day 3 analysis.|Fisher Exact|||||||0.47
91595502|NCT01765920|183081364|SUPERIORITY|||||||0.72||||||Day 4 analysis.|Fisher Exact|||||||0.72
91595503|NCT01765920|183081364|SUPERIORITY|||||||0.25||||||Day 5 analysis.|Fisher Exact|||||||0.25
91595504|NCT01765920|183081365|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
91595505|NCT00777101|183081375|NON_INFERIORITY|Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.|Hazard Ratio (HR)|1.19||||0.231|TWO_SIDED|95.0|0.89|1.6|||Log Rank|The log-rank test comparing treatment groups is stratified by region.|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.|||1.60|0.89|0.231
91595506|NCT01947816|183081385|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
91595507|NCT01947816|183081385|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
91595508|NCT01947816|183081385|SUPERIORITY|||||||0.5512|||||||paired t-test|||Change from Baseline When Discontinued||||0.5512
91595509|NCT01947816|183081385|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
91595510|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 4||||< 0.0001
91595511|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 8||||< 0.0001
91595512|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 16||||< 0.0001
91595513|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
91595514|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
91648976|NCT00830063|183190615|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.52|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.52|<0.001
91595515|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline when discontinued||||< 0.0001
91595516|NCT01947816|183081387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
91595517|NCT00841789|183081393|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.10
91783925|NCT05407064|183448301|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0046
91595518|NCT00841789|183081394|SUPERIORITY|||||||0.86|||||||Regression, Cox|||We applied a Generalized Estimating Equation (GEE) model to determine z score change values (see Protocol page 36 in Supplement).||||0.86
91648977|NCT00830063|183190615|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.26||0.007|TWO_SIDED|95.0|-1.23|-0.2||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.20|-1.23|0.007
91783926|NCT05407064|183448301|SUPERIORITY|||||||0.0052|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0052
91783927|NCT05407064|183448301|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
91783928|NCT05407064|183448301|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
91595519|NCT00841789|183081395|SUPERIORITY|||||||0.83|||||||GEE|||General Estimating Equation||||.83
91595520|NCT00841789|183081395|OTHER|Generallzed Estimating Equation was used for z-score change within groups compared to baseline|General Estimating Equation|||||0.1279|||||||GEE|||We analyzed change from baseline for both etanercept and placebo. LS mean change J(standard error) reported||||0.1279
91595521|NCT00841789|183081396|OTHER|General Estimating Equation for 3 coronary arteries.||||||0.03|||||||GEE|||General Estimating Equation|Generalize estimating equation for 3 coronary arteries evaluated in each patient by echocardiography|||0.03
91595522|NCT00841789|183081396|OTHER|see above||||||0.619|||||||GEE|||GEE performed to compare with change in coronary z score from baseline||||0.619
91648978|NCT00830063|183190615|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.068|TWO_SIDED|95.0|-0.99|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.99|0.068
91648979|NCT00830063|183190616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.73|-0.77||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.77|-1.73|<0.001
91783929|NCT05407064|183448302|SUPERIORITY|||||||0.0567|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0567
91783930|NCT05407064|183448302|SUPERIORITY|||||||0.0235|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0235
91783931|NCT05407064|183448302|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
91783932|NCT05407064|183448302|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
91595523|NCT03317795|183081417|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91595524|NCT03317795|183081419|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91595525|NCT03317795|183081420|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Physical composite score||||0.32
91595526|NCT03317795|183081420|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Mental composite score||||0.26
91595527|NCT03317795|183081421|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91595528|NCT03317795|183081422|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
91595529|NCT02424253|183081442|SUPERIORITY||LS Difference|-0.35|||=|0.249|TWO_SIDED|90.0|-1.21|0.51||1-sided p-value.|ANCOVA|The ANCOVA model included baseline value and treatment.||Change from baseline||0.51|-1.21|= 0.249
91595530|NCT02424253|183081443|SUPERIORITY||LS Difference|-5.06|||=|0.01|TWO_SIDED|90.0|-8.66|-1.46||1-sided p-value.|ANCOVA|The ANCOVA model included baseline EASI, stratification variable (worst daily pruritus NRS ≤ 7.5 or \> 7.5) and treatment.||Change from baseline analysis||-1.46|-8.66|= 0.01
91595531|NCT02258451|183081461|SUPERIORITY||Hazard Ratio (HR)|0.891||||0.4843|TWO_SIDED|80.0|0.72|1.102||1-sided SSE-FS hypotheses were tested using a log-rank test with a 2-sided alpha of 0.2, stratified by the randomization stratification factors.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) for SSE-FS was calculated using Cox Proportional Hazards Model, stratified by the same stratification factors as randomization.|The 1-sided null hypothesis that treatment with radium-223 dichloride does not result in superior SSE-FS to treatment with placebo in participant population was tested against the 1-sided alternative hypothesis that the treatment with radium-223 dichloride results in superior SSE-FS time to treatment the placebo. H0: SSE-FS Radium-223+Exemestane/Everolimus \<= SSE-FS Placebo+Exemestane/Everolimus, versus HA: SSE-FSRadium-223+Exemestane/Everolimus \> SSE-FS Placebo+Exemestane/Everolimus||1.102|0.720|0.4843
91783933|NCT05407064|183448303|SUPERIORITY|||||||0.2632|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2632
91783934|NCT05407064|183448303|SUPERIORITY|||||||0.2962|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2962
91783935|NCT05407064|183448303|SUPERIORITY|||||||0.0013|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0013
91783936|NCT05407064|183448303|SUPERIORITY|||||||0.0547|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0547
91783937|NCT05407064|183448304|SUPERIORITY|||||||0.0937|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0937
91783938|NCT05407064|183448304|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.8230
91783939|NCT05407064|183448304|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0032
91783940|NCT05407064|183448304|SUPERIORITY|||||||0.0129|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0129
91783941|NCT05407064|183448305|SUPERIORITY|||||||0.1889|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1889
91783942|NCT05407064|183448305|SUPERIORITY|||||||0.1589|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1589
91783943|NCT05407064|183448305|SUPERIORITY|||||||0.0008|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0008
91783944|NCT05407064|183448305|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0194
91709274|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|13.75||||0.002|TWO_SIDED|95.0|5.28|22.22|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||22.22|5.28|0.002
91783945|NCT05407064|183448306|SUPERIORITY|||||||0.0057|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0057
91783946|NCT05407064|183448306|SUPERIORITY|||||||0.0168|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0168
91783947|NCT05407064|183448306|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||0.0000
91783948|NCT05407064|183448306|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
91783949|NCT05407064|183448307|SUPERIORITY|||||||0.0958|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0958
91783950|NCT05407064|183448307|SUPERIORITY|||||||0.0544|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0544
91783951|NCT05407064|183448307|SUPERIORITY|||||||0.0029|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0029
91783952|NCT05407064|183448307|SUPERIORITY|||||||0.0006|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0006
91783953|NCT05407064|183448308|SUPERIORITY|||||||0.2038|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.2038
91783954|NCT05407064|183448308|SUPERIORITY|||||||0.1977|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.1977
91783955|NCT05407064|183448308|SUPERIORITY|||||||0.0357|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0357
91783956|NCT05407064|183448308|SUPERIORITY|||||||0.0302|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0302
91783957|NCT05407064|183448309|SUPERIORITY|||||||0.2165|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2165
91783958|NCT05407064|183448309|SUPERIORITY|||||||0.6868|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.6868
91783959|NCT05407064|183448309|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1350
91783960|NCT05407064|183448309|SUPERIORITY|||||||0.0273|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0273
91783961|NCT05407064|183448310|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2450
91783962|NCT05407064|183448310|SUPERIORITY|||||||0.3461|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.3461
91783963|NCT05407064|183448310|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1110
91783964|NCT05407064|183448310|SUPERIORITY|||||||0.2386|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2386
91783965|NCT05407064|183448311|SUPERIORITY|||||||0.1475|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1475
91595532|NCT02258451|183081462|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.8438|TWO_SIDED|95.0|0.697|1.343||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.343|0.697|0.8438
91783966|NCT05407064|183448311|SUPERIORITY|||||||0.0308|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0308
91783967|NCT05407064|183448311|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
91783968|NCT05407064|183448311|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0004
91783969|NCT05407064|183448312|SUPERIORITY|||||||0.0873|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0873
91783970|NCT05407064|183448312|SUPERIORITY|||||||0.1702|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1702
91783971|NCT05407064|183448312|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0007
91783972|NCT05407064|183448312|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0001
91783973|NCT05407064|183448313|SUPERIORITY|||||||0.4193|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.4193
91783974|NCT05407064|183448313|SUPERIORITY|||||||0.1663|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1663
91783975|NCT05407064|183448313|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0002
91783976|NCT05407064|183448313|SUPERIORITY|||||||0.0306|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0306
91783977|NCT05407064|183448314|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0534
91783978|NCT05407064|183448314|SUPERIORITY|||||||0.6551|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.6551
91783979|NCT05407064|183448314|SUPERIORITY|||||||0.0079|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0079
91595533|NCT02258451|183081463|SUPERIORITY||Hazard Ratio (HR)|0.962||||0.8811|TWO_SIDED|95.0|0.577|1.604||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.604|0.577|0.8811
91783980|NCT05407064|183448314|SUPERIORITY|||||||0.1133|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.1133
91595534|NCT02258451|183081464|SUPERIORITY||Hazard Ratio (HR)|0.928||||0.6537|TWO_SIDED|95.0|0.667|1.289||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|Participants with baseline WPS \> 8 were included in the analysis population but censored at Day 1.||1.289|0.667|0.6537
91783981|NCT05407064|183448315|SUPERIORITY|||||||0.1248|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1248
91783982|NCT05407064|183448315|SUPERIORITY|||||||0.1788|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1788
91783983|NCT05407064|183448315|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0030
91783984|NCT05407064|183448315|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0534
91783985|NCT04236141|183448428|SUPERIORITY||Difference in Response Rates|10.71|||||TWO_SIDED|95.0|-19.0|40.43||||||||40.43|-19.00|
91783986|NCT04236141|183448429|SUPERIORITY||Difference in Response Rates|7.14|||||TWO_SIDED|95.0|-22.03|36.31||||||||36.31|-22.03|
91783987|NCT04236141|183448430|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
91783988|NCT04236141|183448431|SUPERIORITY||Difference in Response Rates|21.43|||||TWO_SIDED|95.0|-9.44|52.3||||||||52.30|-9.44|
91783989|NCT04236141|183448432|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
91783990|NCT04236141|183448433|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
91783991|NCT04236141|183448434|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-12.7|48.42||||||||48.42|-12.70|
91783992|NCT04236141|183448435|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
91783993|NCT04236141|183448436|SUPERIORITY||Difference in Response Rates|25.0|||||TWO_SIDED|95.0|-10.38|60.38||||||||60.38|-10.38|
91783994|NCT04236141|183448437|SUPERIORITY||Difference in Response Rates|3.57|||||TWO_SIDED|95.0|-33.84|40.98||||||||40.98|-33.84|
91783995|NCT02160899|183448520|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91783996|NCT02160899|183448520|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91595535|NCT02258451|183081465|SUPERIORITY||Hazard Ratio (HR)|0.884||||0.4496|TWO_SIDED|95.0|0.641|1.219||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.219|0.641|0.4496
91595536|NCT02258451|183081466|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.3467|TWO_SIDED|95.0|0.66|1.157||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.157|0.660|0.3467
91595537|NCT02258451|183081467|SUPERIORITY||Risk Difference (RD)|4.1||||0.556|TWO_SIDED|95.0|-10.2|18.4||P-value was calculated using a 2-sided Cochran-Mantel-Haenszel test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Cochran-Mantel-Haenszel|||||18.4|-10.2|0.556
91709275|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|5.23||||0.243|TWO_SIDED|95.0|-3.56|14.02|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||14.02|-3.56|0.243
91783997|NCT02160899|183448520|SUPERIORITY|||||||0.044|||||||Exact Wilcoxon Rank Sum Test|||||||0.044
91595538|NCT02958007|183081506|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
91595539|NCT03021499|183081507|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.001|TWO_SIDED|95.0|1.64|4.27|||Regression, Logistic|The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region.||The primary endpoint was the proportion of subjects showing renal response at Week 52 as adjudicated by the Clinical Endpoints Committee.||4.27|1.64|<0.001
91595540|NCT03021499|183081508|SUPERIORITY||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.51|2.7|||Log Rank|||||2.7|1.51|<0.001
91595541|NCT03021499|183081510|SUPERIORITY||Odds Ratio (OR)|2.23||||0.002|TWO_SIDED|95.0|1.34|3.72|||Regression, Cox||The hazard ratios are from a Cox's proportional hazards model with terms for treatment arm, baseline UPCR, biopsy class, MMF use at baseline and Region|||3.72|1.34|0.002
91595542|NCT03021499|183081511|SUPERIORITY||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.56|3.79||Week 24|Regression, Logistic||Week 24|Week 24||3.79|1.56|<0.001
91595543|NCT03021499|183081511|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51||Week 52|Regression, Logistic||Week 52|Week 52||3.51|1.45|<0.001
91595544|NCT03021499|183081512|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.349|TWO_SIDED|95.0|0.53|1.25|||Regression, Cox|||||1.25|0.53|0.349
91595545|NCT03021499|183081512|SUPERIORITY|||||||0.646|||||||Log Rank|||||||0.646
91709276|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.37||||0.144|TWO_SIDED|95.0|-1.5|10.24|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||10.24|-1.50|0.144
91709277|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.804|TWO_SIDED|95.0|-5.01|6.46|||Baseline peripheral blood eosinophil cou|||Baseline peripheral blood eosinophil count \< 300 cells/μ||6.46|-5.01|0.804
91783998|NCT04473235|183448526|SUPERIORITY||Mean Difference (Final Values)|-0.799|STANDARD_ERROR_OF_MEAN|1.3||0.531|TWO_SIDED||||||t-test, 2 sided|||||||0.531
91783999|NCT04473235|183448527|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.627|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the left hippocampus and left prefrontal cortex.||||0.627
91784000|NCT04473235|183448527|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the right hippocampus and right prefrontal cortex.||||0.120
91784001|NCT00745849|183448554|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
91784002|NCT05111301|183448559|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
91784003|NCT05111301|183448560|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
91784004|NCT05111301|183448561|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.54
91784005|NCT05111301|183448562|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.03
91784006|NCT05111301|183448563|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.001
91784007|NCT05111301|183448564|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.01
91784008|NCT05111301|183448565|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.80
91784009|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|0.96||||0.454|TWO_SIDED|90.0|-1.15|3.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.07|-1.15|0.4540
91784010|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|7.88|||<|0.0001|TWO_SIDED|90.0|5.77|9.99|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||9.99|5.77|< 0.0001
91784011|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|11.33|||<|0.0001|TWO_SIDED|90.0|9.22|13.44|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||13.44|9.22|< 0.0001
91784012|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.0001|TWO_SIDED|90.0|6.48|10.7|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.70|6.48|< 0.0001
91784013|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|8.96|||<|0.0001|TWO_SIDED|90.0|6.85|11.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||11.07|6.85|< 0.0001
91648980|NCT00830063|183190616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.51|-0.55||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.55|-1.51|<0.001
91784014|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|8.07|||<|0.0001|TWO_SIDED|90.0|5.96|10.18|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.18|5.96|< 0.0001
91784015|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||<|0.0001|TWO_SIDED|90.0|3.42|7.64|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.64|3.42|< 0.0001
91648981|NCT00830063|183190616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|95.0|-1.24|-0.28||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.28|-1.24|0.002
91648982|NCT00830063|183190616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.24||0.03|TWO_SIDED|95.0|-1.01|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-1.01|0.030
91709278|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|11.19||||0.029|TWO_SIDED|95.0|1.15|21.23|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||21.23|1.15|0.029
91522102|NCT00406133|182919261|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.50
91522103|NCT00406133|182919261|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.99
91522104|NCT00406133|182919261|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.10
91522105|NCT00406133|182919262|SUPERIORITY_OR_OTHER|||||||0.66||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Glucose variability was assessed by computing the absolute rate of change.||||0.66
91595546|NCT03021499|183081515|SUPERIORITY||Hazard Ratio (HR)|2.05|||<|0.001|TWO_SIDED|95.0|1.62|2.6|||Log Rank|||||2.6|1.62|<0.001
91595547|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 2||-1.9|-7.3|< 0.001
91648983|NCT00830063|183190617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.16||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.16|-0.50|<0.001
91595548|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.014|TWO_SIDED|95.0|-6.1|-0.7|||Mixed Models Analysis|||Week 4||-0.7|-6.1|0.014
91595549|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 8||-1.9|-7.3|< 0.001
91595550|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.39||0.017|TWO_SIDED|95.0|-6.0|-0.6|||Mixed Models Analysis|||Week 12||-0.6|-6|0.017
91595551|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-2.4|STANDARD_ERROR_OF_MEAN|1.4||0.085|TWO_SIDED|95.0|-5.1|0.3|||Mixed Models Analysis|||Week 16||0.3|-5.1|0.085
91595552|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.035|TWO_SIDED|95.0|-5.7|-0.2|||Mixed Models Analysis|||Week 20||-0.2|-5.7|0.035
91648984|NCT00830063|183190617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.014|TWO_SIDED|95.0|-0.39|-0.04||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.04|-0.39|0.014
91595553|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.41||0.121|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 24||0.6|-5|0.121
91595554|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.42||0.12|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 30||0.6|-5|0.12
91648985|NCT00830063|183190617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.026|TWO_SIDED|95.0|-0.36|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.36|0.026
91648986|NCT00830063|183190617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.349|TWO_SIDED|95.0|-0.25|0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.09|-0.25|0.349
91648987|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
91648988|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
91648989|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
91595555|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-2.3|STANDARD_ERROR_OF_MEAN|1.43||0.102|TWO_SIDED|95.0|-5.1|0.5|||Mixed Models Analysis|||Week 36||0.5|-5.1|0.102
91595556|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.44||0.022|TWO_SIDED|95.0|-6.1|0.5|||Mixed Models Analysis|||Week 42||0.5|-6.1|0.022
91595557|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-4.1|STANDARD_ERROR_OF_MEAN|1.45||0.004|TWO_SIDED|95.0|-7.0|-1.3|||Mixed Models Analysis|||Week 48||-1.3|-7|0.004
91595558|NCT03021499|183081516|SUPERIORITY||Mean Difference (Least Squares)|-2.8|STANDARD_ERROR_OF_MEAN|1.46||0.055|TWO_SIDED|95.0|-5.7|0.1|||Mixed Models Analysis|||Week 52||0.1|-5.7|0.055
91595559|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.011|TWO_SIDED|95.0|-1.0|-0.13|||Mixed Models Analysis|||Week 2||-0.13|-1|0.011
91595560|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-0.76|STANDARD_ERROR_OF_MEAN|0.187|<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||Week 4||-0.4|-1.13|<0.001
91595561|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-0.7|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||Week 8||-0.34|-1.05|<0.001
91595562|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-0.94|STANDARD_ERROR_OF_MEAN|0.196|<|0.001|TWO_SIDED|95.0|-1.33|-0.55|||Mixed Models Analysis|||Week 12||-0.55|-1.33|<0.001
91595563|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.18|STANDARD_ERROR_OF_MEAN|0.214|<|0.001|TWO_SIDED|95.0|-1.6|-0.76|||Mixed Models Analysis|||Week 16||-0.76|-1.6|<0.001
91595564|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.16|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|95.0|-1.63|-0.68|||Mixed Models Analysis|||Week 20||-0.68|-1.63|<0.001
91595565|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.15|STANDARD_ERROR_OF_MEAN|0.222|<|0.001|TWO_SIDED|95.0|-1.59|-0.72|||Mixed Models Analysis|||Week 24||-0.72|-1.59|<0.001
91595566|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.02|STANDARD_ERROR_OF_MEAN|0.284|<|0.001|TWO_SIDED|95.0|-1.58|-0.46|||Mixed Models Analysis|||Week 30||-0.46|-1.58|<0.001
91595567|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.21|STANDARD_ERROR_OF_MEAN|0.264|<|0.001|TWO_SIDED|95.0|-1.73|-0.69|||Mixed Models Analysis|||Week 36||-0.69|-1.73|<0.001
91595568|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.37|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.87|-0.86|||Mixed Models Analysis|||Week 42||-0.86|-1.87|<0.001
91595569|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-1.06|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.56|-0.55|||Mixed Models Analysis|||Week 48||-0.55|-1.56|<0.001
91595570|NCT03021499|183081517|SUPERIORITY||Mean Difference (Least Squares)|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||Mixed Models Analysis|||Week 52||-0.46|-1.52|<0.001
91595571|NCT03021499|183081518|SUPERIORITY||Odds Ratio (OR)|2.44||||0.008|TWO_SIDED|95.0|1.26|4.71||Week 24|Regression, Logistic||Week 24|Week 24||4.71|1.26|0.008
91595572|NCT03021499|183081518|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.48|4.0||Week 52|Regression, Logistic||Week 52|Week 52||4.00|1.48|<0.001
91595573|NCT03021499|183081519|SUPERIORITY||Least Squares Mean difference|-0.5||||0.373|TWO_SIDED|95.0|-1.6|0.6||Week 24|Mixed Models Analysis||Week 24|Week 24||0.6|-1.6|0.373
91595574|NCT03021499|183081519|SUPERIORITY||Least Squares Mean difference|-0.5||||0.277|TWO_SIDED|95.0|-1.4|0.4||Week 52|Mixed Models Analysis||Week 52|Week 52||0.4|-1.4|0.277
91595575|NCT03021499|183081520|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|1.389||0.733|TWO_SIDED|95.0|-3.21|2.26|||Mixed Models Analysis|||SF-36 Change from Baseline Week 24||2.26|-3.21|0.733
91595576|NCT03021499|183081520|SUPERIORITY||Mean Difference (Least Squares)|-0.37|STANDARD_ERROR_OF_MEAN|1.481||0.801|TWO_SIDED|95.0|-3.29|2.54|||Mixed Models Analysis|||SF-36 Change from Baseline at Week 52||2.54|-3.29|0.801
91595577|NCT03021499|183081520|SUPERIORITY||Mean Difference (Least Squares)|1.7|STANDARD_ERROR_OF_MEAN|1.442||0.239|TWO_SIDED|95.0|-1.14|4.54|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 24||4.54|-1.14|0.239
91595578|NCT03021499|183081520|SUPERIORITY||Mean Difference (Least Squares)|-0.6|STANDARD_ERROR_OF_MEAN|1.535||0.695|TWO_SIDED|95.0|-3.62|2.42|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 52||2.42|-3.62|0.695
91595579|NCT03021499|183081520|SUPERIORITY||Mean Difference (Least Squares)|-1.89|STANDARD_ERROR_OF_MEAN|1.439||0.19|TWO_SIDED|95.0|-4.72|0.94|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 24||0.94|-4.72|0.19
91595580|NCT03021499|183081520|SUPERIORITY||Mean Difference (Least Squares)|0.826|STANDARD_ERROR_OF_MEAN|1.531||0.826|TWO_SIDED|95.0|-2.67|3.35|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 52||3.35|-2.67|0.826
91595581|NCT00495820|183081521|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91595582|NCT00495820|183081522|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Mixed Models Analysis|||||||=0.01
91595583|NCT01870401|183081546|NON_INFERIORITY|The protocol identified a non-inferiority bound equal to 0.12 (12%).|||||<|0.025|||||||Farrington and Manning|||The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB \< where p is the success rate in each arm and (alpha) is the non-inferiority bound.||||<0.025
91595584|NCT01870401|183081547|SUPERIORITY|||||||0.0222|||||||Wald Test|One-sided Wald test based on model estimate of DCB treatment effect and subject as a random effect.||||||0.0222
91595585|NCT01192022|183081582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.55|9.29||Logistic regression model with treatment and pooled center as factors.|Regression, Logistic|||||9.29|2.55|<0.001
91595586|NCT03045861|183081632|OTHER||Emax|-1.822|||||TWO_SIDED|95.0|-2.333|1.31||||||||1.310|-2.333|
91595587|NCT03045861|183081632|OTHER||ED50|1020.755|||||TWO_SIDED|95.0|100.786|1940.724||||||||1940.724|100.786|
91595588|NCT03045861|183081632|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.095|0.306||||||||0.306|0.095|
91595589|NCT03045861|183081633|OTHER||Emax|-1.801|||||TWO_SIDED|95.0|-2.319|-1.283||||||||-1.283|-2.319|
91595590|NCT03045861|183081633|OTHER||ED50|55.572|||||TWO_SIDED|95.0|3.565|107.579||||||||107.579|3.565|
91595591|NCT03045861|183081633|OTHER||s2e|0.206|||||TWO_SIDED|95.0|0.097|0.314||||||||0.314|0.097|
91595592|NCT03045861|183081634|OTHER||Emax|-1.846|||||TWO_SIDED|95.0|-2.352|-1.34||||||||-1.340|-2.352|
91595593|NCT03045861|183081634|OTHER||ED50|32.415|||||TWO_SIDED|95.0|4.687|60.143||||||||60.143|4.687|
91595594|NCT03045861|183081634|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.094|0.305||||||||0.305|0.094|
91595595|NCT01549275|183081693|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom =1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cells between two groups.||||< 0.005
91595596|NCT01549275|183081693|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured HCC cells with or without concomitant cancer-associated fibroblasts between two groups.||||< 0.005
91595597|NCT01549275|183081693|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cancer-associated fibroblasts alone between two groups.||||> 0.1
91595598|NCT01549275|183081694|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||1
91595599|NCT01549275|183081694|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.032
91595600|NCT01549275|183081694|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.048
91595601|NCT01549275|183081694|SUPERIORITY_OR_OTHER|||||||0.176|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.176
91595602|NCT01549275|183081694|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells.||||0.021
91595603|NCT01549275|183081694|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.129
91595604|NCT00122681|183081695|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.9|||||TWO_SIDED|95.0|79.9|98.3||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.3|79.9|
91595605|NCT00122681|183081695|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|82.9|99.6||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||99.6|82.9|
91595606|NCT00122681|183081695|SUPERIORITY_OR_OTHER||1-Rate Ratio|86.7|||||TWO_SIDED|95.0|39.7|98.7||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.7|39.7|
91595607|NCT00122681|183081695|SUPERIORITY_OR_OTHER||1-Rate Ratio|90.8|||||TWO_SIDED|95.0|78.1|96.9||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||96.9|78.1|
91595608|NCT00122681|183081695|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.7|||||TWO_SIDED|95.0|79.3|98.2||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.2|79.3|
91595609|NCT00122681|183081695|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|44.1|98.8||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.8|44.1|
91595610|NCT00122681|183081696|SUPERIORITY_OR_OTHER||1-Rate Ratio|94.9|||||TWO_SIDED|95.0|87.7|98.4||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||98.4|87.7|
91648990|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
91595611|NCT00122681|183081696|SUPERIORITY_OR_OTHER||1-Rate Ratio|97.6|||||TWO_SIDED|95.0|91.0|99.7||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||99.7|91.0|
91595612|NCT00122681|183081696|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.1|||||TWO_SIDED|95.0|57.2|97.5||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||97.5|57.2|
91595613|NCT00122681|183081696|SUPERIORITY_OR_OTHER||1-Rate Ratio|93.6|||||TWO_SIDED|95.0|86.3|97.5||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.5|86.3|
91595614|NCT00122681|183081696|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|88.5|98.9||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.9|88.5|
91595615|NCT00122681|183081696|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|59.2|97.6||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.6|59.2|
91595616|NCT00122681|183081721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.798||||0.391|TWO_SIDED|95.0|0.476|1.337|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection||1.337|0.476|0.3910
91595617|NCT00122681|183081723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778||||0.3796|TWO_SIDED|95.0|0.444|1.362|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.362|0.444|0.3796
91595618|NCT00122681|183081725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.1035||95.0|0.337|1.106|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.||1.106|0.337|0.1035
91595619|NCT00122681|183081727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.635||||0.2111|TWO_SIDED|95.0|0.312|1.293|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.293|0.312|0.2111
91595620|NCT00783094|183081743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.201|TWO_SIDED|95.0|-1.8|0.4|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.4|-1.8|0.201
91595621|NCT00783094|183081743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.062|TWO_SIDED|95.0|-2.2|0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-2.2|0.062
91595622|NCT00783094|183081744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.356|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-0.7|0.356
91709279|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.887|TWO_SIDED|95.0|-9.19|10.62|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||10.62|-9.19|0.887
91784016|NCT02785770|183448582|SUPERIORITY_OR_OTHER||LS mean difference|3.74||||0.0036|TWO_SIDED|90.0|1.64|5.85|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.85|1.64|0.0036
91784017|NCT02785770|183448583|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.29||||0.8195|TWO_SIDED|90.0|-2.38|1.8|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.80|-2.38|0.8195
91784018|NCT02785770|183448583|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.0004|TWO_SIDED|90.0|2.44|6.64|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.64|2.44|0.0004
91784019|NCT02785770|183448584|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.9146|TWO_SIDED|90.0|-1.95|2.22|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.22|-1.95|0.9146
91784020|NCT02785770|183448584|SUPERIORITY_OR_OTHER||LS mean difference|5.04|||<|0.0001|TWO_SIDED|90.0|2.95|7.14|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.14|2.95|<0.0001
91595623|NCT00783094|183081744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.487|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.3|-0.6|0.487
91595624|NCT00783094|183081745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.228|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.3|-1.3|0.228
91595625|NCT00783094|183081745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.033|TWO_SIDED|95.0|-1.7|-0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.1|-1.7|0.033
91595626|NCT00783094|183081746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.249|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.1|-0.4|0.249
91595627|NCT00783094|183081746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.0|-0.6|0.022
91595628|NCT00783094|183081747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.904|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.3|-0.4|0.904
91595629|NCT00783094|183081747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.||||0.3|-0.4|0.800
91595630|NCT00783094|183081748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.147|TWO_SIDED|95.0|-1.5|0.2|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-1.5|0.147
91595631|NCT00783094|183081748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.094|TWO_SIDED|95.0|-1.6|0.1|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-1.6|0.094
91595632|NCT00783094|183081751|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank-sum test|||||||0.342
91595633|NCT00783094|183081751|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank sum test|||||||0.127
91648991|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
91709280|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.67||||0.002|TWO_SIDED|95.0|2.76|12.59|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||12.59|2.76|0.002
91595634|NCT00783094|183081751|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.705
91595635|NCT00783094|183081751|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.173
91595636|NCT00783094|183081752|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Wilcoxin rank-sum test|||||||0.606
91595637|NCT00783094|183081752|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Wilcoxin rank-sum test|||||||0.149
91595638|NCT00783094|183081753|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxin rank-sum test|||||||0.428
91595639|NCT00783094|183081753|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||Wilcoxin rank-sum test|||||||0.426
91595640|NCT00783094|183081754|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxin rank-sum|||||||0.060
91595641|NCT00783094|183081754|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxin rank-sum|||||||0.212
91595642|NCT01324232|183081766|SUPERIORITY||Pearson correlation|0.0019|||=|0.9827|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between the change from Baseline PRS scores and the DM plasma concentration was equal to zero and was tested using a 2-sided test at the 5% level of significance within active treatment groups. The regression line was fitted using change from baseline in average PRS during Day 57-84 as the dependent variable and the average of log-transformed DM Plasma Concentration at Day 22 and Day 50 as the independent variable.||||= 0.9827
91595643|NCT01324232|183081768|SUPERIORITY||||||=|0.8869|||||||ANCOVA|||Test of dose trend (overall P value)||||=0.8869
91595644|NCT01324232|183081768|SUPERIORITY||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.46|=|0.9381|TWO_SIDED|95.0|-0.94|0.87|||ANCOVA|||Pairwise treatment group vs placebo||0.87|-0.94|=0.9381
91595645|NCT01324232|183081768|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.46|=|0.4128|TWO_SIDED|95.0|-1.28|0.53|||ANCOVA|||Pairwise treatment group vs placebo||0.53|-1.28|=0.4128
91595646|NCT01324232|183081768|SUPERIORITY||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.461|=|0.9427|TWO_SIDED|95.0|-0.88|0.94|||ANCOVA|||Pairwise treatment group vs placebo||0.94|-0.88|=0.9427
91595647|NCT01324232|183081768|SUPERIORITY||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.401|=|0.6075|TWO_SIDED|95.0|-1.0|0.58|||ANCOVA|||Pairwise treatment group vs placebo||0.58|-1.0|=0.6075
91595648|NCT01324232|183081768|SUPERIORITY||Adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.402|=|0.669|TWO_SIDED|95.0|-0.96|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.96|=0.6690
91595649|NCT01324232|183081768|SUPERIORITY||Adjusted mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.38|=|0.7394|TWO_SIDED|95.0|-0.88|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.88|=0.7394
91595650|NCT01324232|183081769|SUPERIORITY||||||=|0.9731|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9731
91595651|NCT01324232|183081769|SUPERIORITY||Mean difference (final values)|1.32|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.46|6.09||||||||6.09|-3.46|
91595652|NCT01324232|183081769|SUPERIORITY||Mean difference (final values)|-3.0|STANDARD_ERROR_OF_MEAN|2.394|||TWO_SIDED|95.0|-7.72|1.72||||||||1.72|-7.72|
91595653|NCT01324232|183081769|SUPERIORITY||Mean difference (final values)|1.2|STANDARD_ERROR_OF_MEAN|2.408|||TWO_SIDED|95.0|-3.54|5.95||||||||5.95|-3.54|
91595654|NCT01324232|183081771|SUPERIORITY||||||=|0.4778||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.4778
91595655|NCT01324232|183081771|SUPERIORITY||Adjusted mean difference|0.49|STANDARD_ERROR_OF_MEAN|3.676|||TWO_SIDED|95.0|-6.76|7.74||||||||7.74|-6.76|
91595656|NCT01324232|183081771|SUPERIORITY||Adjusted mean difference|-1.67|STANDARD_ERROR_OF_MEAN|3.663|||TWO_SIDED|95.0|-8.89|5.56||||||||5.56|-8.89|
91595657|NCT01324232|183081771|SUPERIORITY||Adjusted mean difference|3.43|STANDARD_ERROR_OF_MEAN|3.681|||TWO_SIDED|95.0|-3.83|10.68||||||||10.68|-3.83|
91595658|NCT01324232|183081772|SUPERIORITY||||||=|0.0685|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.0685
91709281|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.79||||0.268|TWO_SIDED|95.0|-2.15|7.74|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||7.74|-2.15|0.268
91595659|NCT01324232|183081772|SUPERIORITY||Mean difference (final values)|-0.51|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-1.85|0.83||||||||0.83|-1.85|
91595660|NCT01324232|183081772|SUPERIORITY||Mean difference (final values)|-0.85|STANDARD_ERROR_OF_MEAN|0.677|||TWO_SIDED|95.0|-2.19|0.48||||||||0.48|-2.19|
91595661|NCT01324232|183081772|SUPERIORITY||Mean difference (final values)|-1.2|STANDARD_ERROR_OF_MEAN|0.681|||TWO_SIDED|95.0|-2.54|0.15||||||||0.15|-2.54|
91595662|NCT01324232|183081773|SUPERIORITY||||||=|0.4201|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.4201
91595663|NCT01324232|183081773|SUPERIORITY||Adjusted mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.473|||TWO_SIDED|95.0|-3.4|2.41||||||||2.41|-3.40|
91595664|NCT01324232|183081773|SUPERIORITY||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.454|||TWO_SIDED|95.0|-3.76|1.97||||||||1.97|-3.76|
91595665|NCT01324232|183081773|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-1.42|4.34||||||||4.34|-1.42|
91595666|NCT01324232|183081774|SUPERIORITY||||||=|0.8068||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.8068
91595667|NCT01324232|183081774|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|-3.47|1.28||||||||1.28|-3.47|
91595668|NCT01324232|183081774|SUPERIORITY||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-2.99|1.74||||||||1.74|-2.99|
91595669|NCT01324232|183081774|SUPERIORITY||Adjusted mean difference|0.31|STANDARD_ERROR_OF_MEAN|1.207|||TWO_SIDED|95.0|-2.07|2.69||||||||2.69|-2.07|
91595670|NCT01324232|183081775|SUPERIORITY||||||=|0.6315||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Oral responses.|ANCOVA|||||||=0.6315
91595671|NCT01324232|183081775|SUPERIORITY||Adjusted mean difference|2.37|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-3.19|7.93||||||||7.93|-3.19|
91595672|NCT01324232|183081775|SUPERIORITY||Adjusted mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-3.83|6.45||||||||6.45|-3.83|
91595673|NCT01324232|183081775|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|2.728|||TWO_SIDED|95.0|-4.01|6.94||||||||6.94|-4.01|
91595674|NCT01324232|183081775|SUPERIORITY||||||=|0.1485|TWO_SIDED|||||P-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Written responses.|ANCOVA|||||||=0.1485
91595675|NCT01324232|183081775|SUPERIORITY||Mean difference (final values)|1.77|STANDARD_ERROR_OF_MEAN|1.558|||TWO_SIDED|95.0|-1.31|4.85||||||||4.85|-1.31|
91595676|NCT01324232|183081775|SUPERIORITY||Mean difference (final values)|-1.68|STANDARD_ERROR_OF_MEAN|1.605|||TWO_SIDED|95.0|-4.86|1.49||||||||1.49|-4.86|
91595677|NCT01324232|183081775|SUPERIORITY||Mean difference (final values)|-1.65|STANDARD_ERROR_OF_MEAN|1.549|||TWO_SIDED|95.0|-4.71|1.41||||||||1.41|-4.71|
91595678|NCT01324232|183081776|SUPERIORITY||||||=|0.1404|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 158 of the 209 participants in the mITT Population were analyzed at Day 22.||||=0.1404
91595679|NCT01324232|183081776|SUPERIORITY||||||=|0.0805|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 152 of the 209 participants in the mITT Population were analyzed at Day 50.||||=0.0805
91595680|NCT01324232|183081776|SUPERIORITY||||||=|0.0551|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 185 of the 209 participants in the mITT Population were analyzed at Day 85.||||=0.0551
91595681|NCT01324232|183081777|SUPERIORITY||||||=|0.9207|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9207
91595682|NCT01265615|183081787|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595683|NCT01265615|183081788|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595684|NCT01265615|183081789|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595685|NCT01265615|183081790|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595686|NCT01265615|183081791|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595687|NCT01265615|183081792|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595688|NCT01265615|183081793|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595689|NCT01265615|183081794|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91709282|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.82||||0.003|TWO_SIDED|95.0|2.64|13.01|||Repeated measure model|||2 asthma exacerbations in the past year||13.01|2.64|0.003
91709283|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.42||||0.361|TWO_SIDED|95.0|-2.78|7.62|||Repeated measure model|||2 asthma exacerbations in the past year||7.62|-2.78|0.361
91784021|NCT02785770|183448585|SUPERIORITY_OR_OTHER||LS mean difference|1.24||||0.3272|TWO_SIDED|90.0|-0.84|3.33|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.33|-0.84|0.3272
91784022|NCT02785770|183448585|SUPERIORITY_OR_OTHER||LS mean difference|4.26||||0.0009|TWO_SIDED|90.0|2.16|6.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.36|2.16|0.0009
91522106|NCT00406133|182919262|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.48
91595690|NCT01265615|183081795|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595691|NCT01265615|183081796|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91595692|NCT01732796|183081797|SUPERIORITY_OR_OTHER||Adjusted response rate|81.4|||<|0.0001|TWO_SIDED|95.0|76.6|86.2|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||86.2|76.6|<0.0001
91595693|NCT01732796|183081797|SUPERIORITY_OR_OTHER||Adjusted response rate|71.7||||0.3989|TWO_SIDED|95.0|66.1|77.4|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||77.4|66.1|0.3989
91595694|NCT01732796|183081798|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|10.8||||0.004|TWO_SIDED|95.0|2.8|18.8|||z-test|based on two sample z-test with continuity correction for variance.||||18.8|2.8|0.0040
91595695|NCT01732796|183081799|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|6.0||||0.0575|TWO_SIDED|95.0|-1.5|13.5|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||13.5|-1.5|0.0575
91595696|NCT01732796|183081800|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|9.9||||0.0089|TWO_SIDED|95.0|1.7|18.1|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||18.1|1.7|0.0089
91595697|NCT02324920|183081831|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.46|||Regression, Cox||||Additional models were implemented to control for country and investigational sites effect on primary endpoint.|0.46|0.11|<0.001
91595698|NCT02324920|183081832|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.002|TWO_SIDED|95.0|0.27|0.75|||Regression, Cox|||||0.75|0.27|0.002
91595699|NCT01757678|183081833|OTHER||Difference in Probability|0.14|||||TWO_SIDED|95.0|0.09|0.19||||||||.19|.09|
91595700|NCT01757678|183081834|OTHER||Difference in Probability|0.09|||||TWO_SIDED|95.0|0.04|0.14||||||||.14|.04|
91595701|NCT03703102|183081842|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
91595702|NCT03703102|183081842|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
91595703|NCT03703102|183081842|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
91595704|NCT03703102|183081842|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
91595705|NCT00876187|183081866|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.21||0.113|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.08|-0.74|0.113
91595706|NCT00876187|183081866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.19|-0.42|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-1.19|<0.001
91595707|NCT00876187|183081866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.31|-0.54|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.54|-1.31|<0.001
91595708|NCT00876187|183081866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.2||0.688|TWO_SIDED|95.0|-0.31|0.47|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.47|-0.31|0.688
91595709|NCT00876187|183081866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.76|0.035
91595710|NCT00876187|183081866|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.006|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.88|0.006
91595711|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.221|TWO_SIDED|95.0|-0.57|0.13|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.13|-0.57|0.221
91648992|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.13|-2.07|<0.001
91648993|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
91595712|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-0.90|<0.001
91595713|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.027|TWO_SIDED|95.0|-0.7|-0.04|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.70|0.027
91595714|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.17||0.082|TWO_SIDED|95.0|-0.04|0.62|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.62|-0.04|0.082
91595715|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.703|TWO_SIDED|95.0|-0.37|0.25|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.25|-0.37|0.703
91595716|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.16||0.379|TWO_SIDED|95.0|-0.17|0.45|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.45|-0.17|0.379
91595717|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|-0.87|-0.11|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.11|-0.87|0.012
91595718|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.67|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.39|<0.001
91595719|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.31|<0.001
91595720|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.862|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.39|-0.33|0.862
91595721|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.85|0.003
91595722|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.76|0.014
91648994|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
91709284|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.34||||0.185|TWO_SIDED|95.0|-3.06|15.75|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||15.75|-3.06|0.185
91595723|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|-0.86|-0.08|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-0.86|0.019
91595724|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.25|<0.001
91595725|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.29|<0.001
91595726|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.19||0.668|TWO_SIDED|95.0|-0.45|0.29|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.29|-0.45|0.668
91595727|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.84|0.005
91595728|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.88|0.002
91595729|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.89|-0.04|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.89|0.032
91784023|NCT02785770|183448586|SUPERIORITY_OR_OTHER||LS mean difference|-0.48||||0.7024|TWO_SIDED|90.0|-2.57|1.6|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.60|-2.57|0.7024
91784024|NCT02785770|183448586|SUPERIORITY_OR_OTHER||LS mean difference|2.26||||0.0768|TWO_SIDED|90.0|0.16|4.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.36|0.16|0.0768
91595730|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.21|-0.41|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.21|<0.001
91595731|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.28|-0.48|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.48|-1.28|<0.001
91595732|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.773|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.34|-0.46|0.773
91595733|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.78|-0.03|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.78|0.035
91595734|NCT00876187|183081869|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.85|-0.1|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-0.85|0.014
91595735|NCT05074251|183081888|SUPERIORITY||Risk Ratio (RR)|1.41|||<|0.05|TWO_SIDED|95.0|1.14|1.75|||Regression, Logistic|||||1.75|1.14|<0.05
91595736|NCT05112536|183081892|OTHER|||||||0.101|||||||Wilcoxon signed-rank test|||||||0.101
91595737|NCT03972969|183081897|SUPERIORITY||Incidence Rate Ratio|0.13|||<|0.05|TWO_SIDED|95.0|0.05|0.32|||negative binomial regression|||||0.32|0.05|<0.05
91595738|NCT03972969|183081897|SUPERIORITY||Incidence Rate Ratio|0.25|||<|0.05|TWO_SIDED|95.0|0.1|0.61|||negative binomial regression|||||0.61|0.10|<0.05
91595739|NCT03972969|183081897|SUPERIORITY||Incidence Rate Ratio|0.52|||<|0.05|TWO_SIDED|95.0|0.19|1.38|||negative binomial regression|||||1.38|0.19|<0.05
91595740|NCT03972969|183081898|SUPERIORITY||Incidence Rate Ratio|0.15|||<|0.05|TWO_SIDED|95.0|0.07|0.33|||negative binomial regression|||||0.33|0.07|<0.05
91595741|NCT03972969|183081898|SUPERIORITY||Incidence Rate Ratio|0.26|||<|0.05|TWO_SIDED|95.0|0.11|0.58|||negative binomial regression|||||0.58|0.11|<0.05
91595742|NCT03972969|183081898|SUPERIORITY||Incidence Rate Ratio|0.58|||<|0.05|TWO_SIDED|95.0|0.25|1.38|||negative binomial regression|||||1.38|0.25|<0.05
91784025|NCT02785770|183448587|SUPERIORITY_OR_OTHER||LS mean difference|-1.97||||0.1201|TWO_SIDED|90.0|-4.06|0.12|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.12|-4.06|0.1201
91784026|NCT02785770|183448587|SUPERIORITY_OR_OTHER||LS mean difference|1.21||||0.3424|TWO_SIDED|90.0|-0.89|3.31|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.31|-0.89|0.3424
91595743|NCT02459795|183081901|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.0|||||TWO_SIDED|90.0|-7.0|12.92|||Yates correction|||||12.92|-7.00|
91784027|NCT02785770|183448588|SUPERIORITY_OR_OTHER||LS mean difference|-1.35||||0.287|TWO_SIDED|90.0|-3.44|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.44|0.2870
91784028|NCT02785770|183448588|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.9334|TWO_SIDED|90.0|-2.21|1.99|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-2.21|0.9334
91784029|NCT02785770|183448589|SUPERIORITY_OR_OTHER||LS mean difference|-2.16||||0.0893|TWO_SIDED|90.0|-4.24|-0.07|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.07|-4.24|0.0893
91784030|NCT02785770|183448589|SUPERIORITY_OR_OTHER||LS mean difference|-2.61||||0.0412|TWO_SIDED|90.0|-4.71|-0.51|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.51|-4.71|0.0412
91784031|NCT02785770|183448590|SUPERIORITY_OR_OTHER||LS mean difference|-1.34||||0.2892|TWO_SIDED|90.0|-3.43|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.43|0.2892
91784032|NCT02785770|183448590|SUPERIORITY_OR_OTHER||LS mean difference|-2.78||||0.0294|TWO_SIDED|90.0|-4.88|-0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.68|-4.88|0.0294
91784033|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|1.28||||0.16|TWO_SIDED|90.0|-0.22|2.78|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.78|-0.22|0.1600
91784034|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|2.38||||0.0092|TWO_SIDED|90.0|0.88|3.87|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.87|0.88|0.0092
91784035|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|0.91||||0.3174|TWO_SIDED|90.0|-0.59|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-0.59|0.3174
91784036|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.7344|TWO_SIDED|90.0|-1.81|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.81|0.7344
91784037|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.5881|TWO_SIDED|90.0|-1.0|1.99|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-1.00|0.5881
91595744|NCT03259074|183081907|SUPERIORITY||Marginal difference|1.51||||0.7164|TWO_SIDED|95.0|-6.63|9.64||Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.|Regression, Logistic|||||9.64|-6.63|0.7164
91595745|NCT03259074|183081907|SUPERIORITY||Marginal difference|1.67||||0.6925|TWO_SIDED|95.0|-6.61|9.95|||Regression, Logistic|Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.||||9.95|-6.61|0.6925
91595746|NCT03259074|183081908|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.18|||||TWO_SIDED|95.0|-0.646|0.293|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.293|-0.646|
91709285|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.986|TWO_SIDED|95.0|-9.5|9.34|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||9.34|-9.50|0.986
91709286|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.87||||0.912|TWO_SIDED|95.0|-14.7|16.44|||Repeated measure model|||Chronic OCS use||16.44|-14.70|0.912
91522107|NCT00406133|182919262|SUPERIORITY_OR_OTHER|||||||0.07||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.07
91522108|NCT00406133|182919263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adjusted for baseline A1c and clinical center.||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).||||<0.001
91522109|NCT00406133|182919264|SUPERIORITY_OR_OTHER||||||<|0.001||||||Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|ANCOVA|Adjusted for baseline value, clinical center and type of continuous glucose monitor.||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||<0.001
91595747|NCT03259074|183081908|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.16|||||TWO_SIDED|95.0|-0.639|0.315|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.315|-0.639|
91648995|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
91784038|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|-0.82||||0.368|TWO_SIDED|90.0|-2.32|0.68|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-2.32|0.3680
91784039|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.42|TWO_SIDED|90.0|-2.23|0.76|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.76|-2.23|0.4200
91784040|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|-3.03||||0.0009|TWO_SIDED|90.0|-4.53|-1.53|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-1.53|-4.53|0.0009
91784041|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|4.46|||<|0.0001|TWO_SIDED|90.0|2.96|5.97|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.97|2.96|< 0.0001
91784042|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|5.83|||<|0.0001|TWO_SIDED|90.0|4.32|7.33|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.33|4.32|< 0.0001
91784043|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.0001|TWO_SIDED|90.0|2.58|5.59|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.59|2.58|< 0.0001
91784044|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|2.53||||0.0059|TWO_SIDED|90.0|1.02|4.03|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.03|1.02|0.0059
91784045|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|2.5||||0.0063|TWO_SIDED|90.0|1.0|4.01|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.01|1.00|0.0063
91784046|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|1.45||||0.1138|TWO_SIDED|90.0|-0.06|2.95|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.95|-0.06|0.1138
91784047|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|-0.36||||0.6976|TWO_SIDED|90.0|-1.86|1.15|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.15|-1.86|0.6976
91784048|NCT02785770|183448591|SUPERIORITY_OR_OTHER||LS mean difference|-2.12||||0.0208|TWO_SIDED|90.0|-3.62|-0.61|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.61|-3.62|0.0208
91784049|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-0.64||||0.576|TWO_SIDED|90.0|-2.53|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-2.53|0.5760
91784050|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-0.94||||0.4126|TWO_SIDED|90.0|-2.83|0.95|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.95|-2.83|0.4126
91784051|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-1.17||||0.3085|TWO_SIDED|90.0|-3.06|0.72|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.72|-3.06|0.3085
91784052|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-0.99||||0.3889|TWO_SIDED|90.0|-2.88|0.9|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.88|0.3889
91784053|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-0.57||||0.6192|TWO_SIDED|90.0|-2.46|1.32|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.32|-2.46|0.6192
91784054|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-2.45||||0.0332|TWO_SIDED|90.0|-4.34|-0.56|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.56|-4.34|0.0332
91648996|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
91522110|NCT00406133|182919265|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.03
91648997|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
91709287|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.46||||0.86|TWO_SIDED|95.0|-17.76|14.84|||Repeated measure model|||Chronic OCS use||14.84|-17.76|0.860
91522111|NCT00406133|182919266|SUPERIORITY_OR_OTHER|||||||0.04||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.04
91522112|NCT00406133|182919266|SUPERIORITY_OR_OTHER|||||||0.46||||||P-value for the 15-24 year age group|Regression, Logistic|||||||0.46
91522113|NCT00406133|182919266|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value for the \>=25 year age group|Regression, Logistic|||||||0.003
91522114|NCT00406133|182919267|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value for 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.24
91522115|NCT00406133|182919267|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.98
91522116|NCT00406133|182919267|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.48
91595748|NCT03259074|183081909|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|4.32|||||TWO_SIDED|95.0|-5.62|14.27|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||14.27|-5.62|
91595749|NCT03259074|183081909|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.09|||||TWO_SIDED|95.0|-9.13|11.31|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||11.31|-9.13|
91648998|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
91522117|NCT00406133|182919268|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value representative of 13 and 26 weeks combined|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.005
91522118|NCT00406133|182919269|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.05
91522119|NCT00406133|182919270|SUPERIORITY_OR_OTHER|||||||0.39||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Glucose variability was assessed by computing the absolute rate of change.||||0.39
91522120|NCT00406133|182919271|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Nominal p-value not adjusted for multiple comparisons|ANCOVA|||||||0.04
91522121|NCT00406133|182919272|SUPERIORITY_OR_OTHER||Ratio of treatment differences|408148.0|||||TWO_SIDED|95.0|-176644.0|3475108.0||||||"ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:~(mean cost\[CGM\] - mean cost \[control\]) / (mean QALY\[CGM\] - mean QALY\[SMBG\]).~Units are dollars per QALY."||3475108|-176644|
91522122|NCT00406133|182919273|SUPERIORITY_OR_OTHER|||||||0.009||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.009
91522123|NCT00406133|182919273|SUPERIORITY_OR_OTHER|||||||0.57||||||P-value for 15-24 year old age group|Regression, Logistic|||||||0.57
91522124|NCT00406133|182919273|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||<0.001
91522125|NCT00406133|182919274|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.18
91522126|NCT00406133|182919274|SUPERIORITY_OR_OTHER|||||||0.84||||||P-value for 15-24 year old age group.|Regression, Logistic|||||||0.84
91522127|NCT00406133|182919274|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for \>=25 year old age group.|Regression, Logistic|||||||0.02
91522128|NCT00406133|182919275|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.01
91522129|NCT00406133|182919275|SUPERIORITY_OR_OTHER|||||||0.8||||||P-value for 14-24 year age group|Regression, Logistic|||||||0.80
91522130|NCT00406133|182919275|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value for \>=25 year age group|Regression, Logistic|||||||0.005
91522131|NCT00406133|182919276|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for the 8-14 year age group|Regression, Logistic|||A post-hoc defined binary outcome of 26-week glycated hemoglobin \<7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.02
91522132|NCT00406133|182919276|SUPERIORITY_OR_OTHER|||||||0.67||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.67
91522133|NCT00406133|182919276|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.006
91709288|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.56||||0.002|TWO_SIDED|95.0|2.76|12.36|||Repeated measure model|||Without chronic OCS use||12.36|2.76|0.002
91648999|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.07|-2.12|<0.001
91649000|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.85|-1.90|<0.001
91649001|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
91649002|NCT00830063|183190618|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
91595750|NCT03259074|183081910|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.183|STANDARD_ERROR_OF_MEAN|0.1517|||TWO_SIDED|95.0|-0.12|0.48|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||0.48|-0.12|
91649003|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
91649004|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
91649005|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
91649006|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
91649007|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.45|-0.52||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.52|-1.45|<0.001
91709289|NCT01402986|183311373|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.28||||0.601|TWO_SIDED|95.0|-3.51|6.06|||Repeated measure model|||Without chronic OCS use||6.06|-3.51|0.601
91595751|NCT03259074|183081910|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.332|STANDARD_ERROR_OF_MEAN|0.1545|||TWO_SIDED|95.0|0.03|0.64|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||0.64|0.03|
91595752|NCT03259074|183081911|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.877|STANDARD_ERROR_OF_MEAN|0.3316|||TWO_SIDED|95.0|0.22|1.53|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||1.53|0.22|
91595753|NCT03259074|183081911|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.419|STANDARD_ERROR_OF_MEAN|0.3357|||TWO_SIDED|95.0|-0.24|1.08|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||1.08|-0.24|
91595754|NCT03259074|183081912|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.54|||||TWO_SIDED|95.0|-5.1|8.18|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||8.18|-5.10|
91595755|NCT03259074|183081913|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|-2.34|||||TWO_SIDED|95.0|-10.18|5.51|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method.|||5.51|-10.18|
91649008|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.02|-1.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.10|-2.02|<0.001
91649009|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.361|TWO_SIDED|95.0|-0.68|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.68|0.361
91649010|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.25|-0.33||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.33|-1.25|<0.001
91649011|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.54|-0.59||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.59|-1.54|<0.001
91709290|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.145|TWO_SIDED|95.0|-0.57|0.08|||Repeated measure model|||Baseline serum periostin \>= median||0.08|-0.57|0.145
91784055|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.7224|TWO_SIDED|90.0|-2.3|1.48|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.48|-2.30|0.7224
91784056|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.6507|TWO_SIDED|90.0|-1.37|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-1.37|0.6507
91595756|NCT03259074|183081914|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|Marginal difference|2.18|||||TWO_SIDED|95.0|-5.34|9.69|||Marginal difference||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||9.69|-5.34|
91595757|NCT03259074|183081915|OTHER||Marginal difference|0.33|||||TWO_SIDED|95.0|-7.08|7.74||Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||7.74|-7.08|
91595758|NCT00705783|183081916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199|||<|0.0001|TWO_SIDED|95.0|0.125|0.317|||Log Rank||Aripiprazole depot/placebo depot|Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.||0.317|0.125|<0.0001
91595759|NCT00705783|183081917|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.|Chi-squared|||||||<0.0001
91595760|NCT00705783|183081918|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91595761|NCT00705783|183081919|SUPERIORITY_OR_OTHER|||||||0.1756||95.0|||||Chi-squared|||||||0.1756
91595762|NCT00705783|183081920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.11|||<|0.0001|TWO_SIDED|95.0|-12.68|-7.54|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-7.54|-12.68|<0.0001
91595763|NCT00705783|183081921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.35|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.35|-0.70|<0.0001
91784057|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-1.72||||0.1366|TWO_SIDED|90.0|-3.62|0.18|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.18|-3.62|0.1366
91595764|NCT00705783|183081922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82|||<|0.0001|TWO_SIDED|95.0|-4.72|-2.91|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||Positive Subscale Score||-2.91|-4.72|<0.0001
91595765|NCT00705783|183081923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0001|TWO_SIDED|95.0|-2.04|-0.67|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.67|-2.04|0.0001
91595766|NCT00705783|183081924|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91595767|NCT00705783|183081925|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
91595768|NCT02411539|183081959|SUPERIORITY|Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution||||||0.16||||||Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.||||0.16
91595769|NCT01664559|183081996|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.99
91649012|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.04|-1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.09|-2.04|<0.001
91649013|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.063|TWO_SIDED|95.0|-0.93|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.93|0.063
91784058|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-2.81||||0.0153|TWO_SIDED|90.0|-4.71|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-4.71|0.0153
91784059|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-1.88||||0.104|TWO_SIDED|90.0|-3.78|0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.02|-3.78|0.1040
91595770|NCT01664559|183081997|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) Anticipated pain||||0.31
91595771|NCT01664559|183081997|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||0.33
91595772|NCT01664559|183081997|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.72
91595773|NCT01664559|183081997|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.36
91595774|NCT01664559|183081997|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.64
91595775|NCT01664559|183081997|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) 5 min after placement||||<0.001
91595776|NCT01664559|183081997|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 15 min after placement||||<0.001
91595777|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) anticipated pain||||0.6
91709291|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.05||||0.759|TWO_SIDED|95.0|-0.28|0.38|||Repeated measure model|||Baseline serum periostin \>= median||0.38|-0.28|0.759
91709292|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.936|TWO_SIDED|95.0|-0.38|0.35|||Repeated measure model|||Baseline serum periostin \< median||0.35|-0.38|0.936
91784060|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-1.51||||0.1924|TWO_SIDED|90.0|-3.41|0.4|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.40|-3.41|0.1924
91595778|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||1.0
91595779|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.34
91595780|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.32
91595781|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.04
91595782|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) IUD placement||||0.02
91595783|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 5 min after placement||||0.32
91595784|NCT01664559|183081998|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||8\) 15 min after placement||||0.02
91595785|NCT01664559|183081999|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)||||> 0.05
91595786|NCT01664559|183081999|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Injection site pain (just as bad or worse than IUD procedure)||||0.76
91595787|NCT01664559|183081999|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Satisfied or very satisfied with IUD placement procedure||||0.76
91595788|NCT01664559|183081999|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||Would recommend IUD placement to a friend||||0.35
91595789|NCT01664559|183081999|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Desires additional pain medication||||0.02
91595790|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||Level of training, PGY 1, 2, 3, 4 and Attending||||0.2
91595791|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||IUD type (levonorgestrel or copper)||||0.09
91595792|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Purpose of IUD (contraception or heavy menstrual bleeding)||||1.0
91595793|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Chi-squared|||Position of uterus (anteverted, retroverted, midpositioned)||||0.92
91595794|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Need for cervical dilation||||1.0
91595795|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared, Corrected|||Able to complete the IUD insertion||||1.0
91595796|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Chi-squared|||Significant bleeding||||0.24
91595797|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Major complications||||1.0
91595798|NCT01664559|183082000|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Took acetaminophen prior to leaving the office||||0.02
91595799|NCT03631732|183082001|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (CI) of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-4.8|0.9|||||Differences in percentages of participants with HIV-1 RNA \>= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||0.9|-4.8|
91595800|NCT03631732|183082001|SUPERIORITY|||||||0.3399|||||||Fisher Exact|||||||0.3399
91595801|NCT03631732|183082003|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.8|||||TWO_SIDED|95.0|-2.0|6.8|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||6.8|-2.0|
91595802|NCT03631732|183082003|SUPERIORITY|||||||0.3532|||||||Fisher Exact|||||||0.3532
91595803|NCT03631732|183082004|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.4|||||TWO_SIDED|95.0|-1.0|5.3|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||5.3|-1.0|
91595804|NCT03631732|183082004|SUPERIORITY|||||||0.3356|||||||Fisher Exact|||||||0.3356
91595805|NCT03631732|183082006|OTHER||Difference in LSM|11.0||||0.5618|TWO_SIDED|95.0|-27.0|49.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||49|-27|0.5618
91595806|NCT03631732|183082007|OTHER||Difference in LSM|9.0||||0.6632|TWO_SIDED|95.0|-31.0|48.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||48|-31|0.6632
91595807|NCT02255409|183082058|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-6.7|9.7||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||9.7|-6.7|
91709293|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.28||||0.127|TWO_SIDED|95.0|-0.64|0.08|||Repeated measure model|||Baseline serum periostin \< median||0.08|-0.64|0.127
91595808|NCT02255409|183082058|OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-14.2|2.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||2.3|-14.2|
91595809|NCT02255409|183082058|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|8.4|24.1||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||24.1|8.4|
91595810|NCT02255409|183082058|OTHER||Mean Difference (Final Values)|14.2|||||TWO_SIDED|95.0|6.3|22.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||22.0|6.3|
91595811|NCT02255409|183082059|OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|2.2||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||2.2|-0.9|
91595812|NCT02255409|183082059|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||1.2|-1.9|
91595813|NCT02255409|183082059|OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|9.3|20.0||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||20.0|9.3|
91595814|NCT02255409|183082059|OTHER||Mean Difference (Final Values)|26.0|||||TWO_SIDED|95.0|20.6|32.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||32.0|20.6|
91595815|NCT02255409|183082063|OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-1.6|13.0||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||13.0|-1.6|
91595816|NCT02255409|183082063|OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-5.5|9.8||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.8|-5.5|
91595817|NCT02255409|183082063|OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|5.3|18.3||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||18.3|5.3|
91595818|NCT02255409|183082063|OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-8.4|5.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||5.7|-8.4|
91595819|NCT02255409|183082064|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|2.4|8.4||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||8.4|2.4|
91595820|NCT02255409|183082064|OTHER||Mean Difference (Final Values)|5.6|||||TWO_SIDED|95.0|3.1|9.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.3|3.1|
91649014|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.43|-0.48||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.48|-1.43|<0.001
91649015|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.71||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.71|-1.70|<0.001
91649016|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.85|-0.86||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.86|-1.85|<0.001
91649017|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.006|TWO_SIDED|95.0|-1.19|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-1.19|0.006
91649018|NCT00830063|183190619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.34|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.34|<0.001
91649019|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
91649020|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
91784061|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-1.94||||0.0928|TWO_SIDED|90.0|-3.84|-0.04|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.04|-3.84|0.0928
91649021|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
91649022|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
91649023|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
91649024|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.13|-2.07|<0.001
91649025|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
91649026|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
91784062|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-2.06||||0.0745|TWO_SIDED|90.0|-3.96|-0.16|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.16|-3.96|0.0745
91784063|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-1.01||||0.3836|TWO_SIDED|90.0|-2.91|0.9|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.91|0.3836
91649027|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
91595821|NCT02255409|183082064|OTHER||Mean Difference (Final Values)|33.2|||||TWO_SIDED|95.0|25.0|40.9||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||40.9|25.0|
91595822|NCT02255409|183082064|OTHER||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|29.6|44.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||44.7|29.6|
91595823|NCT02255409|183082065|OTHER||GMT Ratio|1.94|||||TWO_SIDED|95.0|1.6|2.4||||||The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 1.||2.4|1.6|
91595824|NCT02255409|183082065|OTHER||GMT Ratio|1.48|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 22.||1.7|1.3|
91595825|NCT02255409|183082065|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 181.||1.7|1.3|
91595826|NCT02255409|183082065|OTHER||GMT Ratio|2.16|||||TWO_SIDED|95.0|1.7|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||2.7|1.7|
91595827|NCT02255409|183082065|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||1.5|1.2|
91595828|NCT02255409|183082065|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||1.6|1.2|
91595829|NCT02255409|183082065|OTHER||GMT Ratio|1.82|||||TWO_SIDED|95.0|1.5|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.2|1.5|
91595830|NCT02255409|183082065|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.5|2.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 22.||2.0|1.5|
91595831|NCT02255409|183082065|OTHER||GMT Ratio|1.85|||||TWO_SIDED|95.0|1.6|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 181.||2.2|1.6|
91649028|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
91649029|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
91595832|NCT02255409|183082065|OTHER||GMT Ratio|3.24|||||TWO_SIDED|95.0|2.7|4.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 1.||4.0|2.7|
91595833|NCT02255409|183082065|OTHER||GMT Ratio|1.49|||||TWO_SIDED|95.0|1.2|1.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 22.||1.8|1.2|
91595834|NCT02255409|183082065|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 181.||1.5|1.1|
91784064|NCT02785770|183448592|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0734|TWO_SIDED|90.0|-3.97|-0.17|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.17|-3.97|0.0734
91595835|NCT02255409|183082067|OTHER||Mean Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-5.2|16.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||16.3|-5.2|
91595836|NCT02255409|183082067|OTHER||Mean Difference (Final Values)|14.5|||||TWO_SIDED|95.0|5.3|23.6||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||23.6|5.3|
91784065|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|0.8||||0.2588|TWO_SIDED|90.0|-0.36|1.96|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.96|-0.36|0.2588
91784066|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.8465|TWO_SIDED|90.0|-1.03|1.3|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.30|-1.03|0.8465
91595837|NCT02255409|183082068|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|9.5|24.1||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||24.1|9.5|
91595838|NCT02255409|183082068|OTHER||Mean Difference (Final Values)|46.4|||||TWO_SIDED|95.0|35.9|55.8||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||55.8|35.9|
91595839|NCT02255409|183082069|OTHER||GMT Ratio|2.63|||||TWO_SIDED|95.0|1.8|3.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||3.8|1.8|
91595840|NCT02255409|183082069|OTHER||GMT Ratio|1.57|||||TWO_SIDED|95.0|1.3|2.9||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.9|1.3|
91595841|NCT02255409|183082069|OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||2.2|1.3|
91595842|NCT02255409|183082069|OTHER||GMT Ratio|1.99|||||TWO_SIDED|95.0|1.5|2.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.6|1.5|
91595843|NCT02255409|183082069|OTHER||GMT Ratio|2.21|||||TWO_SIDED|95.0|1.8|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.7|1.8|
91595844|NCT02255409|183082069|OTHER||GMT Ratio|2.55|||||TWO_SIDED|95.0|2.1|3.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||3.2|2.1|
91595845|NCT00135668|183082071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.2|STANDARD_DEVIATION|16.16|<|0.001|TWO_SIDED|95.0|-18.44|-13.97|||t-test, 2 sided|Paired t-test used.||Paired t-test used to test the null hypothesis of no change in MAP from baseline.||-13.97|-18.44|<0.001
91595846|NCT00135668|183082071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|15.68|<|0.001|TWO_SIDED|95.0|-15.45|-6.55|||t-test, 2 sided|Paired t-test.||||-6.55|-15.45|<0.001
91595847|NCT00135668|183082071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.0|STANDARD_DEVIATION|12.88|<|0.001|TWO_SIDED|95.0|-20.7|-13.3|||t-test, 2 sided|Paired t-test.||||-13.30|-20.70|<0.001
91595848|NCT00135668|183082071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_DEVIATION|15.95|<|0.001|TWO_SIDED|95.0|-24.38|-15.58|||t-test, 2 sided|Paired t-test.||||-15.58|-24.38|<0.001
91595849|NCT00135668|183082071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.6|STANDARD_DEVIATION|18.63|<|0.001|TWO_SIDED|95.0|-21.87|-11.39|||t-test, 2 sided|Paired t-test||||-11.39|-21.87|<0.001
91595850|NCT02370615|183082082|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|2.012|||||TWO_SIDED|90.0|1.632|2.481||||||Analysis for TAK 272F||2.481|1.632|
91595851|NCT02370615|183082082|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.089|||||TWO_SIDED|90.0|0.064|0.123||||||Analysis for TAK 272-M-I||0.123|0.064|
91595852|NCT02370615|183082083|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.888|||||TWO_SIDED|90.0|4.137|5.777||||||Analysis for TAK 272F||5.777|4.137|
91595853|NCT02370615|183082084|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.702|||||TWO_SIDED|90.0|3.969|5.569||||||Analysis for TAK 272F||5.569|3.969|
91595854|NCT02370615|183082084|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.023|||||TWO_SIDED|90.0|0.012|0.045||||||Analysis for TAK 272-M-I||0.045|0.012|
91595855|NCT02370615|183082086|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.349|||||TWO_SIDED|90.0|1.117|1.628||||||||1.628|1.117|
91595856|NCT02370615|183082087|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.02|||||TWO_SIDED|90.0|0.919|1.131||||||||1.131|0.919|
91709294|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.13||||0.343|TWO_SIDED|95.0|-0.41|0.14|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.14|-0.41|0.343
91595857|NCT02370615|183082088|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.155|||||TWO_SIDED|90.0|1.035|1.289||||||||1.289|1.035|
91595858|NCT02370615|183082090|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.235|||||TWO_SIDED|90.0|1.1|1.387||||||Analysis for Midazolam||1.387|1.100|
91595859|NCT02370615|183082090|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|0.887|||||TWO_SIDED|90.0|0.781|1.008||||||Analysis for 1'Hydroxymidazolam||1.008|0.781|
91595860|NCT02370615|183082091|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.422|||||TWO_SIDED|90.0|1.29|1.568||||||Analysis for Midazolam||1.568|1.290|
91595861|NCT02370615|183082091|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.081|||||TWO_SIDED|90.0|1.008|1.16||||||Analysis for 1'Hydroxymidazolam||1.160|1.008|
91595862|NCT02370615|183082092|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.425|||||TWO_SIDED|90.0|1.291|1.574||||||Analysis for Midazolam||1.574|1.291|
91595863|NCT02370615|183082092|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.061|||||TWO_SIDED|90.0|0.986|1.143||||||Analysis for 1'Hydroxymidazolam||1.143|0.986|
91595864|NCT02290873|183082099|SUPERIORITY||Difference in Rates|0.8961|||<|0.0001|TWO_SIDED|95.0|0.8505|0.9416||P-value calculated from a Cochran-Mantel-Haenszel test accounting for fentanyl strata.|Cochran-Mantel-Haenszel|||||0.9416|0.8505|<0.0001
91595865|NCT02290873|183082100|SUPERIORITY||Hazard Ratio (HR)|6.133|||<|0.0001|TWO_SIDED|95.0|4.416|8.517|||Log Rank|||||8.517|4.416|<0.0001
91595866|NCT03715153|183082103|SUPERIORITY||Estimate of the adjusted difference|0.35|STANDARD_ERROR_OF_MEAN|0.71||0.617|TWO_SIDED|95.0|-1.04|1.75|||t-test, 2 sided|General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline.|Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.04|0.617
91595867|NCT03715153|183082104|SUPERIORITY||Estimate of the adjusted difference|0.48|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-5.91|6.88|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||6.88|-5.91|
91595868|NCT03715153|183082105|SUPERIORITY||Estimate of the adjusted difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.24|0.16|||||Rank-based analysis (Wilcoxon scores) including terms for fixed categorical effects of treatment, country and gender. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||0.16|-0.24|
91595869|NCT03715153|183082106|SUPERIORITY||Estimate of the adjusted difference|0.16|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-1.42|1.75|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.42|
91595870|NCT03715153|183082110|SUPERIORITY||Estimate of the adjusted difference|-0.26|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-5.12|4.59||||||||4.59|-5.12|
91595871|NCT00078325|183082127|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|Treatment and country as factors.||||||0.0001
91595872|NCT00078325|183082127|SUPERIORITY_OR_OTHER|||||||0.0008|||||||ANOVA|Treatment and country as factors.||||||0.0008
91595873|NCT00078325|183082128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
91595874|NCT00078325|183082128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
91595875|NCT01519765|183082145|SUPERIORITY_OR_OTHER|||||||0.1611|||||||Fisher Exact|||A consecutive sample will be used as women are recruited. Based on an 80% power and an alpha of 0.05, a sample size of 103 subjects in each arm is required to detect a 20% difference between deliveries within 24hrs between the two treatment arms. An effect size of 20% was selected as this is thought to be a clinically significant difference. This is based on the Wing study showing 50% delivery within 24 hrs with vaginal misoprostol.||||0.1611
91595876|NCT01519765|183082146|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||0.018
91595877|NCT01519765|183082147|SUPERIORITY_OR_OTHER|||||||0.0623|||||||Kruskal-Wallis|||||||0.0623
91595878|NCT01519765|183082148|SUPERIORITY_OR_OTHER|||||||0.1141|TWO_SIDED||||||Kruskal-Wallis|||||||0.1141
91595879|NCT01519765|183082149|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
91595880|NCT01519765|183082150|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
91595881|NCT01519765|183082151|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Kruskal-Wallis|||||||0.093
91595882|NCT01519765|183082152|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Fisher Exact|||||||0.2417
91595883|NCT01519765|183082153|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
91595884|NCT01519765|183082154|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED||||||Fisher Exact|||||||0.1054
91595885|NCT01519765|183082155|SUPERIORITY_OR_OTHER|||||||0.8043|TWO_SIDED||||||Fisher Exact|||||||0.8043
91595886|NCT01519765|183082156|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Fisher Exact|||||||0.797
91595887|NCT01519765|183082157|SUPERIORITY_OR_OTHER|||||||0.751|||||||Fisher Exact|||||||0.751
91595888|NCT01519765|183082158|SUPERIORITY_OR_OTHER|||||||0.6244|TWO_SIDED||||||Fisher Exact|||||||0.6244
91595889|NCT01519765|183082159|SUPERIORITY_OR_OTHER|||||||0.7906|TWO_SIDED||||||Fisher Exact|||||||0.7906
91595890|NCT01519765|183082160|SUPERIORITY_OR_OTHER|||||||0.5118|TWO_SIDED||||||Fisher Exact|||||||0.5118
91595891|NCT01519765|183082161|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
91709295|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.928|TWO_SIDED|95.0|-0.29|0.27|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.27|-0.29|0.928
91595892|NCT01519765|183082162|SUPERIORITY_OR_OTHER|||||||0.741|TWO_SIDED||||||Fisher Exact|||||||0.741
91595893|NCT01519765|183082163|SUPERIORITY_OR_OTHER|||||||0.579|TWO_SIDED||||||Kruskal-Wallis|||||||0.579
91595894|NCT01519765|183082164|SUPERIORITY_OR_OTHER|||||||0.8062|||||||Kruskal-Wallis|||Score for Nausea and vomiting||||.8062
91595895|NCT01519765|183082164|SUPERIORITY_OR_OTHER|||||||0.1505|||||||Kruskal-Wallis|||Effectiveness||||0.1505
91595896|NCT01519765|183082164|SUPERIORITY_OR_OTHER|||||||0.1223|||||||Kruskal-Wallis|||Patient concern||||0.1223
91595897|NCT01519765|183082164|SUPERIORITY_OR_OTHER|||||||0.538||||||Patient satisfaction|Kruskal-Wallis|||Labor satisfaction||||0.5380
91595898|NCT01519765|183082165|SUPERIORITY_OR_OTHER|||||||0.2868||||||This is the overall p value of all rows.|Chi-squared|||||||0.2868
91595899|NCT02943564|183082166|SUPERIORITY||Least Squares Mean Difference|0.1||||0.8862|TWO_SIDED|95.0|-1.5|1.73|||Mixed Model Repeated Measures (MMRM)|||||1.73|-1.50|0.8862
91595900|NCT02943564|183082166|SUPERIORITY||Least Squares Mean Difference|-0.5||||0.5772|TWO_SIDED|95.0|-2.07|1.16|||Mixed Model Repeated Measures (MMRM)|||||1.16|-2.07|0.5772
91595901|NCT02943564|183082167|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.8967|TWO_SIDED|95.0|-1.48|1.29|||Mixed Model Repeated Measures (MMRM)|||||1.29|-1.48|0.8967
91595902|NCT02943564|183082167|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9963|TWO_SIDED|95.0|-1.38|1.39|||Mixed Model Repeated Measures (MMRM)|||||1.39|-1.38|0.9963
91595903|NCT02012621|183082204|OTHER||Odds Ratio (OR)|73.5|||<|0.0001|TWO_SIDED|95.0|25.7|210.5|||Regression, Logistic|||||210.5|25.7|<0.0001
91595904|NCT02012621|183082205|OTHER||Odds Ratio (OR)|8.5||||0.0012|TWO_SIDED|95.0|2.3|30.9|||Regression, Logistic|||||30.9|2.3|0.0012
91595905|NCT02012621|183082206|OTHER||Odds Ratio (OR)|4.7|||<|0.0001|TWO_SIDED|95.0|2.6|8.7|||Regression, Logistic|||||8.7|2.6|<0.0001
91595906|NCT00533442|183082228|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Kidney (logrank test).||||0.01
91595907|NCT00533442|183082228|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Pancreas (logrank test).||||0.01
91595908|NCT00533442|183082228|SUPERIORITY|||||||0.16|||||||Log Rank|||Death-Censored Kidney Graft Failure (logrank test).||||0.16
91595909|NCT00533442|183082228|SUPERIORITY|||||||0.12|||||||Log Rank|||Death-Censored Pancreas Graft Failure (logrank test).||||0.12
91595910|NCT00533442|183082228|SUPERIORITY|||||||0.96|||||||Log Rank|||Death-Uncensored (Kidney \& Pancreas) Graft Survival (logrank test).||||0.96
91595911|NCT00533442|183082228|SUPERIORITY||||||>|0.99||||||Patient Death (logrank test).|Log Rank|||||||>0.99
91595912|NCT00533442|183082229|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Comparison of Mean eGFR at 12 Months Post-Transplant (t-test).||||0.21
91595913|NCT00533442|183082229|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Comparison of Mean eGFR at 36 Months Post-Transplant (t-test).||||0.71
91595914|NCT00533442|183082229|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Comparison of Mean eGFR at 60 Months Post-Transplant (t-test).||||0.33
91595915|NCT00533442|183082230|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 12 Months Post-Transplant (t-test).||||.47
91595916|NCT00533442|183082230|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 36 Months Post-Transplant (t-test).||||0.97
91595917|NCT00533442|183082230|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 60 Months Post-Transplant (t-test).||||0.75
91595918|NCT00874120|183082259|SUPERIORITY_OR_OTHER||residual error term from the ANOVA|-0.5||||0.548|TWO_SIDED|95.0|-2.0|1.1||P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.|ANOVA|||||1.1|-2.0|0.5480
91613984|NCT00431847|183121845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3299|STANDARD_ERROR_OF_MEAN|0.3372||0.3286|TWO_SIDED|95.0|-0.3334|0.9932|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9932|-0.3334|0.3286
91613985|NCT00431847|183121845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8591|STANDARD_ERROR_OF_MEAN|0.4716||0.0694|TWO_SIDED|95.0|-0.06841|1.7866|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.7866|-0.06841|0.0694
91595919|NCT03615183|183082260|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.36|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.72%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
91595920|NCT03615183|183082260|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.63|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.86%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
91595921|NCT03615183|183082260|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.92|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 9.42%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
91595922|NCT00105443|183082277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6931||||0.00583||95.0|0.5549|0.8658||According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).|Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and tumor burden. In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here."||0.8658|0.5549|0.00583
91595923|NCT00105443|183082278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0764||||0.7676||95.0|0.8837|1.311|||Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and tumor burden. This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study."||1.3110|0.8837|0.7676
91595924|NCT00105443|183082279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5764||||7e-06||95.0|0.4484|0.741|||Log Rank||This is the sorafenib to placebo hazard ratio.|"In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and tumor burden."||0.7410|0.4484|0.000007
91595925|NCT00105443|183082280|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.95||||0.001641||95.0|-19.56|-4.35|||Cochran-Mantel-Haenszel||Sorafenib minus placebo difference|"Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and tumor burden."||-4.35|-19.56|0.001641
91595926|NCT03187769|183082287|SUPERIORITY||Least Squares Mean Difference|-1.87||||0.012|TWO_SIDED|95.0|-3.33|-0.41|||ANCOVA|||||-.41|-3.33|.012
91595927|NCT01623271|183082293|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91595928|NCT00393887|183082325|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Fisher Exact|||Two-sided Fisher's exact test||||0.11
91595929|NCT02017327|183082374|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91595930|NCT02017327|183082374|SUPERIORITY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
91595931|NCT01265797|183082384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare outcome measures between two treatment groups in the run-in month minus blinded month||The a priori alpha level was set at p \< 0.05, and a power of 0.80 (80%) was used to compute the number of subjects needed to find a meaningful difference between the verum and sham groups. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group.||||0.30
91649030|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
91595932|NCT01265797|183082385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare secondary outcome measures between two treatment groups in the run-in month minus open label month||||||0.89
91595933|NCT01265797|183082386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
91649031|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||-1.59|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.07|-2.12|<0.001
91649032|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.85|-1.90|<0.001
91709296|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.23||||0.374|TWO_SIDED|95.0|-0.74|0.28|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.28|-0.74|0.374
91595934|NCT01265797|183082387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare the primary and secondary outcome measures between the two treatment groups.||The a priori alpha level was set at p \< 0.05, and beta 0.2. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group. The null hypothesis: No difference in the depression score/14 day recall between the two groups.||||0.98
91595935|NCT01265797|183082388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.75
91595936|NCT01265797|183082389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
91595937|NCT01265797|183082390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.02|TWO_SIDED|||||Change in mean anxiety score/ 14 day recall from the blinded period to open label period|Wilcoxon (Mann-Whitney)|||||||0.02
91595938|NCT01265797|183082391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.98
91595939|NCT01265797|183082392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
91595940|NCT01265797|183082393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
91595941|NCT01265797|183082394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
91595942|NCT01265797|183082395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.92
91595943|NCT01923129|183082411|NON_INFERIORITY|The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe \& Altman.|||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91595944|NCT03998046|183082449|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||.85
91595945|NCT03998046|183082451|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.20
91649033|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
91649034|NCT00830063|183190620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
91649035|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.026|TWO_SIDED|95.0|-0.96|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.96|0.026
91709297|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.29||||0.259|TWO_SIDED|95.0|-0.81|0.22|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.22|-0.81|0.259
91522134|NCT00406133|182919277|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
91595946|NCT03998046|183082452|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.38
91595947|NCT03998046|183082453|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
91595948|NCT03998046|183082454|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
91595949|NCT03998046|183082455|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
91595950|NCT03998046|183082456|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||.61
91595951|NCT03998046|183082457|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||.56
91595952|NCT01699542|183082521|SUPERIORITY|||||||0.159|||||||Generalized Linear Model|||||||0.159
91595953|NCT04341441|183082548|SUPERIORITY|Sample size was determined with one planned interim analysis when 50% of participants had completed their 8 weeks of treatment using an O'Brien-Fleming alpha spending method to ensure an overall type 1 error of 0.05. With a sample size of 900 per group and alpha = 0.0492, the power to detect a 32% reduction in COVID-19 disease rate (10% vs 6.8%) between the placebo and HCQ treated groups, determined at 87%. Study required 1000 per group with a total of 3000 patients to complete the trial.|Risk Ratio (RR)|0.32||||0.75|TWO_SIDED|||||P-value for the comparison between groups, including the non-randomized active comparator, was 0.75.|Mantel Haenszel||Low number of primary events precluded estimated value of risk ratio.|||||0.75
91595954|NCT03924752|183082617|OTHER|A two-way repeated-measures analysis of variance (ANOVA) was performed on different walking conditions (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed across different locomotion modes by setting the significant value to 0.05. Two independent variables were assistance type (Exo vs No Exo) and different locomotion modes.||||||0.9547||||||This presents the effect of exoskeleton assistance on the user's preferred overground walking speed across different locomotion modes.|ANOVA|||||||0.9547
91595955|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||All sites combined (week 6) - Between-group differences of mean in LBP||-0.7|-1.4|
91595956|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.2|-0.5||||||All sites combined (week 12) - Between-group differences of mean in LBP||-0.5|-1.2|
91595957|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.1||||||Walter Reed site (week 6) - Between-group differences of mean in LBP||-0.1|-1.3|
91595958|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Walter Reed site (week 12) - Between-group differences of mean in LBP||0.2|-1.0|
91595959|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.8|-0.6||||||Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP||-0.6|-1.8|
91595960|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.8|-0.5||||||Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP||-0.5|-1.8|
91595961|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-1.9|-0.8||||||Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP||-0.8|-1.9|
91595962|NCT01692275|183082618|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.7|-0.5||||||Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP||-0.5|-1.7|
91595963|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-3.1|-1.2||||||All sites combined (week 6) - RMDQ Between-Group Differences in Disability||-1.2|-3.1|
91595964|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.0|-1.0||||||All sites combined (week 12) - RMDQ Between-Group Differences in Disability||-1.0|-3.0|
91595965|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.4|-0.2||||||Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability||-0.2|-3.4|
91595966|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.2|0.2||||||Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability||0.2|-3.2|
91595967|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.8|-0.4||||||Pensacola site (week 6) - RMDQ Between-Group Differences in Disability||-0.4|-3.8|
91595968|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-3.7|-0.2||||||Pensacola site (week 12) - RMDQ Between-Group Differences in Disability||-0.2|-3.7|
91595969|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.3|-1.1||||||San Diego site (week 6) - RMDQ Between-Group Differences in Disability||-1.1|-4.3|
91595970|NCT01692275|183082619|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.4|-1.1||||||San Diego site (week 12) - RMDQ Between-Group Differences in Disability||-1.1|-4.4|
91595971|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
91595972|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
91595973|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
91595974|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
91595975|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
91595976|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
91595977|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.7|-0.2||||||San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.7|
91595978|NCT01692275|183082620|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1||||||San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.1|-0.7|
91595979|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.6|-0.8||||||All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-1.6|
91595980|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.6|-0.7||||||All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-1.6|
91595981|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.02||||||Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.02|-1.3|
91595982|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-1.5|-0.1||||||Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.1|-1.5|
91595983|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.0|-0.7||||||Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-2.0|
91595984|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-2.3|-0.8||||||Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-2.3|
91595985|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.3|-1.0||||||San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-1.0|-2.3|
91595986|NCT01692275|183082621|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.9|-0.5||||||San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.5|-1.9|
91595987|NCT01692275|183082622|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.97||||||Week 6: All 3 sites combined||0.97|0.54|
91595988|NCT01692275|183082622|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.58|1.0||||||Week 12: All 3 sites combined||1.0|0.58|
91595989|NCT01692275|183082623|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.13|0.25||||||All sites combined: 6 weeks||0.25|0.13|
91595990|NCT01692275|183082623|SUPERIORITY||Odds Ratio (OR)|0.26|||||TWO_SIDED|95.0|0.16|0.42||||||Walter Reed site: 6 weeks||0.42|0.16|
91595991|NCT01692275|183082623|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.1|0.33||||||Naval Hospital Pensacola site: 6 weeks||0.33|0.10|
91595992|NCT01692275|183082623|SUPERIORITY||Odds Ratio (OR)|0.13|||||TWO_SIDED|95.0|0.08|0.21||||||Naval Medical Center San Diego site: 6 weeks||0.21|0.08|
91595993|NCT01692275|183082624|SUPERIORITY||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|2.1|2.8||||||All sites combined: 6 weeks||2.8|2.1|
91649036|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.43|-1.32|<0.001
91649037|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.23||0.333|TWO_SIDED|95.0|-0.23|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.23|0.333
91595994|NCT01692275|183082624|SUPERIORITY||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|1.4|2.6||||||Walter Reed site: 6 weeks||2.6|1.4|
91595995|NCT01692275|183082624|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|1.6|3.0||||||Naval Hospital Pensacola site: 6 weeks||3.0|1.6|
91595996|NCT01692275|183082624|SUPERIORITY||Mean Difference (Final Values)|3.1|||||TWO_SIDED|95.0|2.5|3.7||||||Naval Medical Center San Diego site: 6 weeks||3.7|2.5|
91595997|NCT03787472|183082665|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least-Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-5.5|6.6|||Linear Mixed Model|The Kenward and Roger method was used for the calculation of the denominator of degrees of freedom.|Mean difference was calculated as Test - Control|||6.6|-5.5|
91595998|NCT03787472|183082666|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.025|0.041|||Linear Mixed Model||Mean difference was calculated as Test - Control|Distance Standard High Contrast Bright||0.041|-0.025|
91595999|NCT03787472|183082666|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|-0.012|STANDARD_ERROR_OF_MEAN|0.0155|||TWO_SIDED|95.0|-0.043|0.019|||Linear Mixed Model||Mean difference was calculated as Test - Control|Intermediate Standard High Contrast Bright||0.019|-0.043|
91596000|NCT03787472|183082666|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0169|||TWO_SIDED|95.0|-0.03|0.037|||Linear Mixed Model||Mean difference was calculated as Test - Control|Near Standard High Contrast Bright||0.037|-0.030|
91596001|NCT02227693|183082674|OTHER||Difference of responder rate vs. placebo|19.5||||0.146|TWO_SIDED|95.0|-18.1|57.0|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||57.0|-18.1|0.146
91596002|NCT02227693|183082674|OTHER||Difference of responder rate vs. placebo|54.5||||0.004|TWO_SIDED|95.0|21.4|87.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||87.7|21.4|0.004
91596003|NCT02227693|183082674|OTHER||Difference of responder rate vs. placebo|30.9||||0.024|TWO_SIDED|95.0|-3.9|65.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||65.7|-3.9|0.024
91596004|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|14.3||||0.388|TWO_SIDED|95.0|-11.6|40.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||40.2|-11.6|0.388
91596005|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|27.3||||0.214|TWO_SIDED|95.0|1.0|53.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||53.6|1.0|0.214
91649038|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.527|TWO_SIDED|95.0|-0.59|0.3||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.30|-0.59|0.527
91649039|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.48|-0.57||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.57|-1.48|<0.001
91649040|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.16|-1.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.25|-2.16|<0.001
91649041|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.574|TWO_SIDED|95.0|-0.58|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|-0.58|0.574
91649042|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.26|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.26|<0.001
91649043|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.67|-1.60|<0.001
91649044|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.1|-1.17||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.17|-2.10|<0.001
91649045|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.055|TWO_SIDED|95.0|-0.92|0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.01|-0.92|0.055
91709298|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.11|-0.84|0.127
91596006|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|62.3||||0.012|TWO_SIDED|95.0|24.8|99.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||99.9|24.8|0.012
91596007|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|72.7||||0.001|TWO_SIDED|95.0|44.3|100.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||100.0|44.3|0.001
91596008|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|40.9||||0.063|TWO_SIDED|95.0|5.6|76.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||76.2|5.6|0.063
91596009|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|-27.3||||0.245|TWO_SIDED|95.0|-53.6|-1.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||-1.0|-53.6|0.245
91596010|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|27.3||||0.386|TWO_SIDED|95.0|-12.2|66.8||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||66.8|-12.2|0.386
91596011|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|-7.3||||1|TWO_SIDED|95.0|-43.4|28.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.9|-43.4|1.000
91596012|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|-18.2||||0.496|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.496
91596013|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|-9.1||||1|TWO_SIDED|95.0|-37.5|19.3||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||19.3|-37.5|1.000
91596014|NCT02227693|183082675|OTHER||Difference of proportion vs. placebo|-18.2||||0.476|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.476
91596015|NCT02227693|183082676|OTHER||Difference of proportion vs. placebo|63.6||||0.003|TWO_SIDED|95.0|35.2|92.1||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||92.1|35.2|0.003
91596016|NCT02227693|183082676|OTHER||Difference of proportion vs. placebo|30.0||||0.09|TWO_SIDED|95.0|1.6|58.4||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||58.4|1.6|0.090
91596017|NCT02227693|183082676|OTHER||Difference of proportion vs. placebo|10.0||||0.476|TWO_SIDED|95.0|-8.6|28.6||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.6|-8.6|0.476
91596018|NCT02227693|183082679|OTHER|||||||0.296||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.296
91596019|NCT02227693|183082679|OTHER|||||||0.07||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.070
91596020|NCT02227693|183082679|OTHER|||||||0.138||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.138
91596021|NCT02227693|183082679|OTHER|||||||0.012||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.012
91522135|NCT00406133|182919278|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||0.002
91596022|NCT02227693|183082679|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
91596023|NCT02227693|183082679|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
91596024|NCT02227693|183082679|OTHER|||||||0.624||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.624
91596025|NCT02227693|183082679|OTHER|||||||0.009||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.009
91596026|NCT02227693|183082679|OTHER|||||||0.01||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.010
91596027|NCT02227693|183082679|OTHER|||||||0.154||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.154
91596028|NCT02227693|183082679|OTHER|||||||0.216||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.216
91649046|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.42|<0.001
91596029|NCT02227693|183082679|OTHER|||||||0.901||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.901
91596030|NCT00132132|183082698|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|This analysis is the per protocol unadjusted value||||||0.03
91596031|NCT00132132|183082698|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|Age adjusted per protocol||||||0.14
91596032|NCT00132132|183082698|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.||||||0.006
91596033|NCT00132132|183082699|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
91596034|NCT03776175|183082700|SUPERIORITY||Difference in LS mean|-44.52||||0|TWO_SIDED|90.0|-54.97|-31.65|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in least square (LS) mean between groups||-31.65|-54.97|0.0000
91596035|NCT03776175|183082700|SUPERIORITY||Difference in LS Mean|-35.4||||0.0007|TWO_SIDED|90.0|-47.4|-20.68|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference LS mean between groups.||-20.68|-47.40|0.0007
91649047|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.75|-0.79||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.79|-1.75|<0.001
91649048|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.95|-0.99||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.99|-1.95|<0.001
91709299|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.42|-0.56|0.775
91596036|NCT03776175|183082700|SUPERIORITY||Difference in LS Mean|-44.64||||0|TWO_SIDED|90.0|-54.8|-32.19|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||-32.19|-54.80|0.0000
91596037|NCT03776175|183082700|SUPERIORITY||Difference in LS Mean|-0.21||||0.9836|TWO_SIDED|90.0|-15.66|18.08|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||18.08|-15.66|0.9836
91596038|NCT03776175|183082700|SUPERIORITY||Difference in LS Mean|-14.3||||0.1233|TWO_SIDED|90.0|-27.32|1.06|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||1.06|-27.32|0.1233
91596039|NCT03776175|183082700|SUPERIORITY||Difference in LS Mean|-0.21|||||TWO_SIDED|50.0|-6.82|6.87|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||6.87|-6.82|
91596040|NCT03776175|183082700|SUPERIORITY||Difference in LS Mean|-14.3|||||TWO_SIDED|50.0|-19.86|-8.35|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||-8.35|-19.86|
91596041|NCT00930761|183082713|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.06||95.0|0.99|1.51|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.51|0.99|0.06
91596042|NCT00930761|183082714|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.13||95.0|0.73|5.66|||Chi-squared|||||5.66|0.73|0.13
91596043|NCT00930761|183082715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||0.03||95.0|1.01|1.57|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.57|1.01|0.03
91596044|NCT00930761|183082716|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.09||95.0|0.95|1.71|||Chi-squared|||||1.71|0.95|0.09
91596045|NCT03699007|183082723|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91596046|NCT03699007|183082724|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91596047|NCT01970995|183082725|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|13.49|||<|0.001|TWO_SIDED|95.0|10.96|16.6||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.60|10.96|<.001
91613585|NCT01899144|183121466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
91649049|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.24||0.006|TWO_SIDED|95.0|-1.15|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-1.15|0.006
91649050|NCT00830063|183190621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.39||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.39|-1.34|<0.001
91596048|NCT01970995|183082726|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|50.67|||<|0.001|TWO_SIDED|95.0|44.88|57.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||57.20|44.88|<.001
91596049|NCT01970995|183082727|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|10.97|||<|0.001|TWO_SIDED|95.0|9.26|12.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||12.99|9.26|<.001
91596050|NCT01970995|183082728|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|44.94|||<|0.001|TWO_SIDED|95.0|42.11|47.97||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||47.97|42.11|<.001
91596051|NCT01970995|183082729|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.25|||<|0.001|TWO_SIDED|95.0|17.38|31.11||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||31.11|17.38|<.001
91596052|NCT03882970|183082762|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.86|||<|0.001|TWO_SIDED|95.0|-1.0|-0.72|||Mixed Models Analysis|||||-0.72|-1.00|<0.001
91596053|NCT03882970|183082762|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.17|-0.9|||Mixed Models Analysis|||||-0.90|-1.17|<0.001
91596054|NCT03882970|183082763|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.73|-0.45|||Mixed Models Analysis|||||-0.45|-0.73|<0.001
91596055|NCT03882970|183082764|SUPERIORITY||LS Mean Difference|-9.8|||<|0.001|TWO_SIDED|95.0|-10.8|-8.8|||Mixed Models Analysis|||||-8.8|-10.8|<0.001
91596056|NCT03882970|183082764|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-14.0|-11.9|||Mixed Models Analysis|||||-11.9|-14.0|<0.001
91596057|NCT03882970|183082764|SUPERIORITY||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-16.2|-14.2|||Mixed Models Analysis|||||-14.2|-16.2|<0.001
91649051|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
91709300|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
91596058|NCT03882970|183082765|SUPERIORITY||LS Mean Difference|7.5||||0.004|TWO_SIDED|95.0|2.4|12.5|||Mixed Models Analysis|||||12.5|2.4|0.004
91596059|NCT03882970|183082765|SUPERIORITY||LS Mean Difference|0.8||||0.751|TWO_SIDED|95.0|-4.3|5.9|||Mixed Models Analysis|||||5.9|-4.3|0.751
91596060|NCT03882970|183082765|SUPERIORITY||LS Mean Difference|-3.6||||0.168|TWO_SIDED|95.0|-8.7|1.5|||Mixed Models Analysis|||||1.5|-8.7|0.168
91596061|NCT03882970|183082766|SUPERIORITY||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.38|5.01|||Regression, Logistic|||||5.01|2.38|<0.001
91596062|NCT03882970|183082766|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|4.55|10.84|||Regression, Logistic|||||10.84|4.55|<0.001
91596063|NCT03882970|183082766|SUPERIORITY||Odds Ratio (OR)|10.79|||<|0.001|TWO_SIDED|95.0|6.65|17.48|||Regression, Logistic|||||17.48|6.65|<0.001
91596064|NCT03882970|183082768|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.001|TWO_SIDED|95.0|18.35|48.35|||Regression, Logistic|||||48.35|18.35|<0.001
91596065|NCT03882970|183082768|SUPERIORITY||Odds Ratio (OR)|79.88|||<|0.001|TWO_SIDED|95.0|47.56|134.17|||Regression, Logistic|||||134.17|47.56|<0.001
91596066|NCT03882970|183082768|SUPERIORITY||Odds Ratio (OR)|110.77|||<|0.001|TWO_SIDED|95.0|64.73|189.55|||Regression, Logistic|||||189.55|64.73|<0.001
91649052|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
91649053|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
91709301|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
91596067|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|-0.26||||0.096|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Hyperglycemia||0.05|-0.57|0.096
91596068|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|-0.25||||0.113|TWO_SIDED|95.0|-0.57|0.06|||ANCOVA|||Hyperglycemia||0.06|-0.57|0.113
91596069|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|-0.47||||0.003|TWO_SIDED|95.0|-0.78|-0.16|||ANCOVA|||Hyperglycemia||-0.16|-0.78|0.003
91596070|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|-0.41||||0.014|TWO_SIDED|95.0|-0.74|-0.08|||ANCOVA|||Hypoglycemia||-0.08|-0.74|0.014
91709302|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.181|TWO_SIDED|95.0|-0.59|0.11|||Repeated measure model|||Th2 high||0.11|-0.59|0.181
91596071|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|-0.18||||0.28|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.51|0.280
91596072|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|-0.26||||0.129|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Hypoglycemia||0.07|-0.59|0.129
91596073|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|3.01|||<|0.001|TWO_SIDED|95.0|2.26|3.75|||ANCOVA|||Treatment Satisfaction Score||3.75|2.26|<0.001
91596074|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.15|3.65|||ANCOVA|||Treatment Satisfaction Score||3.65|2.15|<0.001
91596075|NCT03882970|183082769|SUPERIORITY||LS Mean Difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74|||ANCOVA|||Treatment Satisfaction Score||3.74|2.24|<0.001
91596076|NCT02813694|183082782|NON_INFERIORITY|non-inferiority margin= 10%|Treatment difference|0.1|||||TWO_SIDED|95.0|-4.4|4.5|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic|||4.5|-4.4|
91596077|NCT02813694|183082783|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.1|-6.3|
91596078|NCT02813694|183082783|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.|||3.3|-6.5|
91596079|NCT02813694|183082784|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.2|0.5|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\]; PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||0.5|-8.2|
91596080|NCT02813694|183082784|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.4|0.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.|||0.7|-8.4|
91596081|NCT04474795|183082785|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Compared pre and post training scores||||<0.0001
91596082|NCT04474795|183082786|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Comparison of scores pre and post training in individuals who completed training modules||||<0.0001
91596083|NCT04474795|183082787|SUPERIORITY|||||||0.606|||||||Wilcoxon paired signed rank test|||Patient autonomy||||0.606
91596084|NCT04474795|183082787|SUPERIORITY|||||||0.003|||||||Wilcoxon paired signed rank test|||Value of tight control||||0.003
91596085|NCT04474795|183082787|SUPERIORITY|||||||0.475|||||||Wilcoxon paired signed rank test|||Need for Special Training||||0.475
91596086|NCT04474795|183082788|SUPERIORITY|||||||0.009|||||||Wilcoxon paired signed rank test|||||||0.009
91596087|NCT00814775|183082794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.72|TWO_SIDED|95.0|0.55|2.37|||Regression, Cox||CTrach vs. Fastrach|||2.37|0.55|0.72
91596088|NCT00814775|183082795|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.45|TWO_SIDED|95.0|0.38|1.54|||Regression, Cox||CTrach vs. Fastrach|||1.54|0.38|0.45
91596089|NCT00749996|183082814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.228|TWO_SIDED|95.0|-1.59|0.38|||t-test, 2 sided|||The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.||0.38|-1.59|0.228
91596090|NCT00749996|183082815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.719|TWO_SIDED|95.0|-8.8|6.08|||t-test, 2 sided|||The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.||6.08|-8.80|0.719
91596091|NCT02189213|183082835|OTHER|The parameters were the CGI-Improvement scale which comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The hypothesis is that \~50% of subjects receiving treatment will not respond.|||||=|0.0002|||||||t-test, 2 sided|||At least 50% of subjects will respond to Sertraline treatment (CGI greater than or equal to 2).||||=0.0002
91596092|NCT00768521|183082867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.18||||0.008||90.0|7.58|41.06||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|Primary Hypothesis: Tolterodine LA 4 mg is superior to placebo with respect to change from baseline in maximum cystometric capacity at 4 hours post Dose 7 (i.e., steady state). The expected treatment effect is targeted at 40 mL.|||41.06|7.58|0.008
91596093|NCT00768521|183082868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.422||90.0|-11.5|16.71||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.||||16.71|-11.5|0.422
91596094|NCT01445951|183082885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 0.4 margin|Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|0.02|0.36||||||MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit\*treatment)||0.36|0.02|
91784067|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|1.02||||0.1502|TWO_SIDED|90.0|-0.15|2.18|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.18|-0.15|0.1502
91596095|NCT01445951|183082886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.02|0.04|||||Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\*Treatment)|||0.04|-0.02|
91596096|NCT01445951|183082887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.42|STANDARD_ERROR_OF_MEAN|10.622|||TWO_SIDED|95.0|-56.25|-14.59|||||MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\*Treatment)|||-14.59|-56.25|
91596097|NCT01445951|183082890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.512||0.0102|TWO_SIDED|95.0|-2.33|-0.31|||ANCOVA|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|||-0.31|-2.33|0.0102
91596098|NCT01445951|183082890|SUPERIORITY_OR_OTHER|||||||0.4955|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.4955
91784068|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.97|TWO_SIDED|90.0|-1.19|1.14|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.14|-1.19|0.9700
91596099|NCT01445951|183082890|SUPERIORITY_OR_OTHER|||||||0.6807|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.6807
91596100|NCT01445951|183082890|SUPERIORITY_OR_OTHER|||||||0.0079|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.0079
91596101|NCT01445951|183082892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5328||||0.0156|TWO_SIDED|95.0|0.3198|0.8877|||Regression, Logistic|Logistic model with affects for Region, Basal insulin stratum, and Treatment||||0.8877|0.3198|0.0156
91596102|NCT01445951|183082893|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||<0.0001
91596103|NCT01445951|183082894|SUPERIORITY_OR_OTHER|||||||0.1022|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||0.1022
91596104|NCT01445951|183082895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.449||||0.0158|TWO_SIDED|95.0|0.23|0.86|||Regression, Logistic|Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c|Gen2 in the numerator, Aspart in the denominator|||0.86|0.23|0.0158
91709303|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.25||||0.161|TWO_SIDED|95.0|-0.6|0.1|||Repeated measure model|||Th2 high||0.10|-0.60|0.161
91709304|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
91784069|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-1.18||||0.0947|TWO_SIDED|90.0|-2.34|-0.02|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.34|0.0947
91784070|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.7759|TWO_SIDED|90.0|-0.96|1.36|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.36|-0.96|0.7759
91596105|NCT03099187|183082944|SUPERIORITY||Difference in Group Means|-134.6||||0.6777|TWO_SIDED|95.0|-772.4|503.3||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|t-test, 2 sided|||Primary Analysis in 2019. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||503.3|-772.4|0.6777
91596106|NCT03099187|183082944|SUPERIORITY||Difference in Group Means|-216.0||||0.4682|TWO_SIDED|95.0|-803.6|371.7||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||371.7|-803.6|0.4682
91596107|NCT03099187|183082945|SUPERIORITY|||||||0.0383|||||||rank ANCOVA|||Primary Analysis in 2019||||0.0383
91596108|NCT03099187|183082945|SUPERIORITY|||||||0.0239|||||||rank ANCOVA|||Final Analysis in 2020||||0.0239
91596109|NCT03099187|183082946|SUPERIORITY||Overall Mean Difference|95.3||||0.0018|TWO_SIDED|95.0|35.9|154.6||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Primary Analysis in 2019||154.6|35.9|0.0018
91596110|NCT03099187|183082946|SUPERIORITY||Overall Mean Difference|84.3||||0.0096|TWO_SIDED|95.0|20.7|147.8||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020||147.8|20.7|0.0096
91596111|NCT03099187|183082947|SUPERIORITY||Odds Ratio (OR)|0.42||||0.0006|TWO_SIDED|95.0|0.25|0.69||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.69|0.25|0.0006
91596112|NCT03099187|183082947|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0009|TWO_SIDED|95.0|0.26|0.71||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.71|0.26|0.0009
91596113|NCT03099187|183082948|SUPERIORITY||Odds Ratio (OR)|0.44||||0.0114|TWO_SIDED|95.0|0.23|0.84||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.84|0.23|0.0114
91596114|NCT03099187|183082948|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0168|TWO_SIDED|95.0|0.24|0.88||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.88|0.24|0.0168
91596115|NCT03099187|183082949|SUPERIORITY|||||||0.0874||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0874
91649054|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
91649055|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.66|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.66|<0.001
91522136|NCT00406133|182919279|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
91522137|NCT06916468|182919339|OTHER||Proportion|86.79|||<|0.001|TWO_SIDED||||||Binomial test|Comparing preference to 50/50 baseline||||||<0.001
91596116|NCT03099187|183082949|SUPERIORITY|||||||0.1191||||||p-values are not adjusted for multiplicity and are provided for descriptive purpose only.|rank ANCOVA|||Final Analysis in 2020||||0.1191
91596117|NCT03099187|183082950|SUPERIORITY|||||||0.0395||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0395
91596118|NCT03099187|183082950|SUPERIORITY|||||||0.0299||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Final Analysis in 2020||||0.0299
91596119|NCT03099187|183082951|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.7788|TWO_SIDED|95.0|-5.0|5.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||5.00|-5.00|0.7788
91596120|NCT03099187|183082951|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.8289|TWO_SIDED|95.0|-5.0|5.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate|rank ANCOVA|||Final Analysis in 2020||5.00|-5.00|0.8289
91649056|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.72|-0.41||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.41|-0.72|<0.001
91596121|NCT03099187|183082952|SUPERIORITY||Hodges-Lehmann Median difference|0.29||||0.1872|TWO_SIDED|95.0|-0.45|1.04||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.04|-0.45|0.1872
91596122|NCT03099187|183082952|SUPERIORITY||Hodges-Lehmann Median Difference|0.27||||0.2019|TWO_SIDED|95.0|-0.48|1.02||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.02|-0.48|0.2019
91596123|NCT03099187|183082953|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.2995|TWO_SIDED|95.0|-10.0|4.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||4.00|-10.00|0.2995
91649057|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.041|TWO_SIDED|95.0|-0.32|-0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.01|-0.32|0.041
91649058|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.38|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.38|0.006
91649059|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.27||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.27|-0.60|<0.001
91649060|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.29||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.29|-0.62|<0.001
91649061|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.011
91649062|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.07|-0.40|0.006
91649063|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.26||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.26|-0.60|<0.001
91649064|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.14||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.14|-0.48|<0.001
91649065|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.42|-0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.09|-0.42|0.003
91709305|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
91784071|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.9649|TWO_SIDED|90.0|-1.13|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.13|0.9649
91784072|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.9034|TWO_SIDED|90.0|-1.08|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-1.08|0.9034
91596124|NCT03099187|183082953|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.3372|TWO_SIDED|95.0|-10.0|4.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||4.00|-10.00|0.3372
91596125|NCT03099187|183082954|SUPERIORITY||Hodges-Lehmann Median Difference|-1.86||||0.163|TWO_SIDED|95.0|-5.06|1.38|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.38|-5.06|0.1630
91596126|NCT03099187|183082954|SUPERIORITY||Hodges-Lehmann Median Difference|-1.74||||0.1851|TWO_SIDED|95.0|-5.0|1.55||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.55|-5.00|0.1851
91596127|NCT03099187|183082955|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.5922|TWO_SIDED|95.0|0.59|2.49|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. All-cause non-elective hospitalization.||2.49|0.59|0.5922
91596128|NCT03099187|183082955|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.8057|TWO_SIDED|95.0|0.26|2.83|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. Respiratory non-elective hospitalization.||2.83|0.26|0.8057
91649066|NCT00830063|183190622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.105|TWO_SIDED|95.0|-0.3|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.30|0.105
91649067|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
91649068|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
91649069|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
91784073|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.3391|TWO_SIDED|90.0|-1.85|0.49|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.49|-1.85|0.3391
91596129|NCT03099187|183082955|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.4613|TWO_SIDED|95.0|0.63|2.73|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models|Final Analysis in 2020. All-cause non-elective hospitalization.||2.73|0.63|0.4613
91649070|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
91649071|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.64|-0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.32|-0.64|<0.001
91649072|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.74|-0.42||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.42|-0.74|<0.001
91649073|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.094|TWO_SIDED|95.0|-0.3|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.30|0.094
91649074|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.4|-0.08||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.08|-0.40|0.003
91649075|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.23||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.23|-0.57|<0.001
91784074|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-1.19||||0.0948|TWO_SIDED|90.0|-2.35|-0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.35|0.0948
91784075|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.74||||0.2959|TWO_SIDED|90.0|-1.91|0.43|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.43|-1.91|0.2959
91784076|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.9161|TWO_SIDED|90.0|-1.24|1.09|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.09|-1.24|0.9161
91784077|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0036|TWO_SIDED|90.0|-3.24|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-3.24|0.0036
91784078|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.3063|TWO_SIDED|90.0|-1.89|0.44|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.44|-1.89|0.3063
91522138|NCT06916468|182919340|OTHER||Proportion|13.2|||<|0.001|TWO_SIDED||||||Proportion|Out of the 53 participants , what proportion preferred the device without the cotton dampener on majority of anatomical sites||||||<0.001
91649076|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.68|<0.001
91649077|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.35|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.35|0.032
91649078|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.13|-0.46|<0.001
91649079|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.54|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-0.54|<0.001
91649080|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.52|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-0.52|<0.001
91649081|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.012
91649082|NCT00830063|183190623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.03|-0.36|0.021
91649083|NCT00325403|183190664|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|23.0||||0.0125|TWO_SIDED|95.0|4.0|41.0||P-Value|ANCOVA|||Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.||41|4|0.0125
91784079|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.4918|TWO_SIDED|90.0|-1.65|0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-1.65|0.4918
91784080|NCT02785770|183448593|SUPERIORITY_OR_OTHER||LS mean difference|-0.61||||0.3862|TWO_SIDED|90.0|-1.78|0.55|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.55|-1.78|0.3862
91784081|NCT00813943|183448605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.0328|TWO_SIDED|95.0|0.484|0.972||P-value is not adjusted for multiple testing.|Log Rank|||||0.972|0.484|0.0328
91649084|NCT00325403|183190665|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.0||||0.0653|TWO_SIDED|95.0|-2.0|33.0|||ANCOVA|||||33|-2|0.0653
91649085|NCT00325403|183190666|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0307|TWO_SIDED|95.0|1.0|33.0|||ANCOVA|||||33|1|0.0307
91649086|NCT00325403|183190667|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|12.0||||0.0518|TWO_SIDED|95.0|0.0|24.0|||ANCOVA|||||24|0|0.0518
91649087|NCT00325403|183190668|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.000
91649088|NCT00325403|183190669|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.738|TWO_SIDED|95.0|0.0|0.0||"In cases where the value corresponding to overall poorest relative change was imputed for walk distance, a value of IV was used for the WHO functional classification for PAH."|Wilcoxon rank sum test||The values for the estimated parameter and 95% confidence interval were calculated.|||0|0|0.7380
91649089|NCT00325403|183190670|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.4887|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||||0|-1|0.4887
91649090|NCT00325403|183190671|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.6116|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||||1|0|0.6116
91649091|NCT00325403|183190673|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|26.0||||0.0326|TWO_SIDED|95.0|1.0|49.0|||ANCOVA|||||49|1|0.0326
91649092|NCT00325403|183190674|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|16.0||||0.2275|TWO_SIDED|95.0|-15.0|47.0|||ANCOVA|||||47|-15|0.2275
91649093|NCT00325403|183190675|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|32.0||||0.0024|TWO_SIDED|95.0|10.0|55.0|||ANCOVA|||||55|10|0.0024
91649094|NCT00325403|183190676|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|25.5||||0.0001|TWO_SIDED|95.0|10.0|41.0|||ANCOVA|||||41|10|0.0001
91784082|NCT00813943|183448605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.858||||0.3771|TWO_SIDED|95.0|0.612|1.204||P-value is not adjusted for multiple testing.|Log Rank|||||1.204|0.612|0.3771
91784083|NCT05367492|183448618|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.0|14.1|||Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||14.1|3.0|<0.001
91649095|NCT00325403|183190677|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0025|TWO_SIDED|95.0|3.0|33.0|||ANCOVA|||||33|3|0.0025
91649096|NCT00325403|183190678|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|20.0||||0.0008|TWO_SIDED|95.0|7.0|34.0|||ANCOVA|||||34|7|0.0008
91649097|NCT00325403|183190679|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|14.0||||0.0025|TWO_SIDED|95.0|3.9|25.0|||ANCOVA|||||25|3.9|0.0025
91649098|NCT00936884|183190703|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|83.6|||<|0.0001|TWO_SIDED|97.5|6.5|1074.7||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after the first injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||1074.7|6.50|<0.0001
91649099|NCT00936884|183190704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|56.64|||<|0.0001|TWO_SIDED|97.5|40.62|72.66||Comparison of the MNTX group and the placebo group was based on ANOVA model with the proportion of injections resulting in RFBM within 4 hours during the double-blind period as the dependent variable and the treatment group as the fixed effect. .|ANOVA||Estimated value is the difference in least squared means for MNTX vs. placebo (MNTX minus placebo). Based on the ANOVA model, there is 97.5% confidence that the difference between MNTX and placebo falls between the lower and upper limits presented.|||72.66|40.62|<0.0001
91649100|NCT00936884|183190705|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.38|||<|0.0001|TWO_SIDED|97.5|10.91|50.14||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after each injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||50.14|10.91|< 0.0001
91649101|NCT01663714|183190706|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with unconfirmed response.|||100|100|
91649102|NCT01663714|183190707|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with confirmed response.|||100|100|
91649103|NCT00597584|183190728|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.078|||TWO_SIDED|95.0|-0.05|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study has been determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||0.26|-0.05|
91649104|NCT00597584|183190729|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.24|||Cochran-Mantel-Haenszel|||||1.24|0.50|
91649105|NCT00597584|183190730|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.87|1.07|||Cochran-Mantel-Haenszel|||||1.07|0.87|
91649106|NCT03726437|183190753|SUPERIORITY|Analyses were performed to determine whether RealConsent was superior to Stress and Mood Management in reducing incidence of sexual violence victimization.|Risk Ratio (RR)|0.48||||0.0002|TWO_SIDED|95.0|0.33|0.69|||Mixed Models Analysis|Models adjusted for fixed effects.||||.69|.33|.0002
91649107|NCT03726437|183190753|SUPERIORITY||Odds Ratio (OR)|0.77||||0.31|TWO_SIDED|95.0|0.47|1.28|||Mixed Models Analysis|Models adjusted for fixed effects.||||1.28|.47|.31
91649108|NCT03726437|183190754|SUPERIORITY||Adjusted OR|1.17||||0.03|TWO_SIDED|95.0|0.12|1.22|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.22|0.12|.03
91649109|NCT03726437|183190755|SUPERIORITY||Adjusted OR|-0.5|||<|0.05|TWO_SIDED|95.0|-1.27|0.27|||Mixed Models Analysis|Model adjusted for fixed effects.||||0.27|-1.27|<.05
91649110|NCT03726437|183190756|SUPERIORITY||Incidence rate ratio|0.81||||0.02|TWO_SIDED|95.0|0.67|0.97|||Mixed Models Analysis|Model adjusted for fixed effects.||||.97|.67|.02
91649111|NCT03726437|183190757|SUPERIORITY||Incidence rate ratio|1.05||||0.43|TWO_SIDED|95.0|0.92|1.2|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.20|.92|.43
91649112|NCT03726437|183190758|SUPERIORITY||Adjusted OR|1.72||||0.006|TWO_SIDED|95.0|1.17|2.55|||Mixed Models Analysis|Model adjusted for fixed effects.||||2.55|1.17|.006
91649113|NCT01889862|183190767|SUPERIORITY||Mean Difference (Net)|-973.02|||<|0.0001|TWO_SIDED|95.0|-1204.19|-741.85||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 20mg/day compared with those who self administer matching placebo.||-741.85|-1204.19|<0.0001
91784084|NCT05367492|183448618|SUPERIORITY||||||<|0.001||||||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the primary outcome measure. Effects were deemed significant for p\<0.05.|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
91784085|NCT05367492|183448619|SUPERIORITY||Odds Ratio (OR)|6.1|||<|0.001|TWO_SIDED|95.0|3.1|12.3||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||12.3|3.1|<0.001
91784086|NCT05367492|183448619|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
91596130|NCT03099187|183082955|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9523|TWO_SIDED|95.0|0.3|3.59|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Final Analysis in 2020. Respiratory non-elective hospitalization.||3.59|0.30|0.9523
91596131|NCT03099187|183082957|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7871|TWO_SIDED|95.0|0.26|2.78|||Log Rank|||||2.78|0.26|0.7871
91596132|NCT03099187|183082958|SUPERIORITY||Cox Proportional Hazard|0.84||||0.366|TWO_SIDED|95.0|0.56|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.24|0.56|0.3660
91596133|NCT03099187|183082958|SUPERIORITY||Cox Proportional Hazard|0.85||||0.4173|TWO_SIDED|95.0|0.57|1.26|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.26|0.57|0.4173
91596134|NCT03099187|183082959|SUPERIORITY||Cox Proportional Hazard|0.79||||0.2726|TWO_SIDED|95.0|0.52|1.2|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.20|0.52|0.2726
91596135|NCT03099187|183082959|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3386|TWO_SIDED|95.0|0.54|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.24|0.54|0.3386
91596136|NCT03099187|183082960|SUPERIORITY||Cox Proportional Hazard|1.01||||0.9969|TWO_SIDED|95.0|0.06|16.08|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||16.08|0.06|0.9969
91596137|NCT03099187|183082961|SUPERIORITY|||||||0.3231|||||||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||||0.3231
91596138|NCT04869345|183083005|SUPERIORITY||Odds Ratio (OR)|0.67||||0.684|TWO_SIDED|95.0|0.13|3.05||A priori threshold for statistical significance = 0.05.|Boschloo Test||Maximum likelihood estimate of the Odds Ratio comparing retention rate in LARKSPUR group to Attention Control group|||3.05|0.13|.684
91649114|NCT01889862|183190767|SUPERIORITY||Mean Difference (Net)|-588.5|||<|0.0001|TWO_SIDED|95.0|-830.07|-346.94||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 40mg/day compared with those who self administer matching placebo.||-346.94|-830.07|<0.0001
91649115|NCT00033631|183190773|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.83|1.2||Two-sided test, significance level = 0.05|Log Rank||Reference level = 70.2 Gy arm|The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.||1.2|0.83|0.98
91784087|NCT05367492|183448620|SUPERIORITY||Odds Ratio (OR)|6.0||||0.001|TWO_SIDED|95.0|2.1|16.9||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||16.9|2.1|0.001
91784088|NCT05367492|183448620|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
91784089|NCT05367492|183448621|SUPERIORITY||Mean Difference (Net)|-1.88||||0.001|TWO_SIDED|95.0|-2.93|-0.83||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.83|-2.93|0.001
91784090|NCT05367492|183448621|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study group.||||||<0.001
91784091|NCT05367492|183448622|SUPERIORITY||Mean Difference (Net)|-6.76|||<|0.001|TWO_SIDED|95.0|-9.08|-4.45||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-4.45|-9.08|<0.001
91784092|NCT05367492|183448622|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus tests of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||<0.001
91784093|NCT05367492|183448623|SUPERIORITY||Mean Difference (Net)|-1.78||||0.008|TWO_SIDED|95.0|-3.08|-0.48||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.48|-3.08|0.008
91649116|NCT00033631|183190774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.7||Two-sided significance level = 0.05|Gray's test|Reference arm is 70.2 Gy arm||||0.70|0.50|<0.0001
91649117|NCT00033631|183190775|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.14|TWO_SIDED|95.0|0.38|1.15|||Gray's test|Two-sided significance level = 0.05|Reference level is 70.2 Gy arm|||1.15|0.38|0.14
91649118|NCT00033631|183190776|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41||||0.0001|TWO_SIDED|95.0|0.25|0.66|||Gray's test|Two-sided significance level = 0.05|Reference level = 70.2 Gy arm|||0.66|0.25|0.0001
91649119|NCT00033631|183190777|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.051|TWO_SIDED|95.0|0.42|1.01||Two-sided significance level = 0.05|Gray's test||Reference level is the 70.2 Gy level|||1.01|0.42|0.051
91649120|NCT00033631|183190778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Two-sided significance level = 0.05|Chi-squared|||||||0.29
91649121|NCT00033631|183190779|SUPERIORITY|||||||0.0513|||||||Chi-squared|Two-sided significance level = 0.05||With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.||||0.0513
91596139|NCT04869345|183083008|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.28||0.835|TWO_SIDED|95.0|-2.8|2.27||The threshold for statistical significance was 0.05.|Mixed Models Analysis|P-value adjusted using the Kenward-Roger (1997) degrees of freedom method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.27|-2.80|0.835
91649122|NCT00033631|183190780|SUPERIORITY|||||||0.59|||||||Chi-squared|Two-sided significance level = 0.05||||||0.59
91649123|NCT01827371|183190790|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|1.32|||||TWO_SIDED|98.33|0.72|1.93||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.93|0.72|
91649124|NCT01827371|183190790|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.86|||||TWO_SIDED|98.33|0.26|1.47||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.47|0.26|
91649125|NCT01827371|183190790|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.41|||||TWO_SIDED|98.33|-0.17|1.0007||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.0007|-0.17|
91649126|NCT01827371|183190791|SUPERIORITY_OR_OTHER|||||||0.4782|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Pain at Injection Site ' Arm A) = Pr('Pain at Injection Site ' Arm D) H1: Pr('Pain at Injection Site ' Arm A) not = Pr('Pain at Injection Site ' Arm D)"||||0.4782
91649127|NCT01827371|183190791|SUPERIORITY_OR_OTHER|||||||0.1704|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Itchiness at Injection Site' Arm A) = Pr('Itchiness at Injection Site' Arm D) H1: Pr('Itchiness at Injection Site' Arm A) not = Pr('Itchiness at Injection Site' Arm D)"||||0.1704
91649128|NCT01827371|183190791|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm pain' Arm A) = Pr('Underarm pain' Arm D) H1: Pr('Underarm pain' Arm A) not = Pr('Underarm pain' Arm D)"||||1.000
91596140|NCT04869345|183083008|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.29||0.732|TWO_SIDED|95.0|-2.12|3.0||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.00|-2.12|0.732
91596141|NCT04869345|183083008|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.38||0.609|TWO_SIDED|95.0|-2.05|3.47||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.47|-2.05|0.609
91596142|NCT04869345|183083009|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|1.08||0.445|TWO_SIDED|95.0|-2.97|1.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.31|-2.97|0.445
91596143|NCT04869345|183083009|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.09||0.209|TWO_SIDED|95.0|-0.78|3.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.54|-0.78|0.209
91596144|NCT04869345|183083009|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|1.17||0.063|TWO_SIDED|95.0|-0.12|4.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||4.54|-0.12|0.063
91709306|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.22||||0.154|TWO_SIDED|95.0|-0.52|0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||0.08|-0.52|0.154
91522139|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
91784094|NCT05367492|183448623|SUPERIORITY|||||||0.02||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus Wald test of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||0.02
91784095|NCT05367492|183448624|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
91522140|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
91522141|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
91522142|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison||||< 0.001
91522143|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison.||||< 0.001
91522144|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.||||||0.126|||||||Bang and Tsiatis|||Inpatient cost comparison||||0.126
91522145|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
91522146|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
91522147|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
91522148|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
91522149|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
91784096|NCT05367492|183448624|SUPERIORITY|||||||0.083|||||||Fisher Exact|||||||0.083
91784097|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1334||||0.1695|TWO_SIDED|95.0|-0.0583|0.3251|||Mixed model for repeated measures|||For Grey matter||0.3251|-0.0583|0.1695
91784098|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.175||||0.1057|TWO_SIDED|95.0|-0.038|0.388|||Mixed model for repeated measures|||For posterior cingulate Gyrus||0.3880|-0.0380|0.1057
91784099|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1426||||0.1833|TWO_SIDED|95.0|-0.0691|0.3543|||Mixed model for repeated measures|||For Frontal lobe||0.3543|-0.0691|0.1833
91613986|NCT00431847|183121846|SUPERIORITY_OR_OTHER||Slope|-0.02332|STANDARD_ERROR_OF_MEAN|0.003777|<|0.0001|TWO_SIDED|95.0|-0.03076|-0.01589|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01589|-0.03076|<0.0001
91522150|NCT04295005|182919341|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
91522151|NCT02790073|182919349|OTHER|Within group comparison vs baseline|||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
91522152|NCT02790073|182919350|OTHER|Within group comparison vs baseline||||||0.015|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.015
91522153|NCT02790073|182919351|OTHER|Within group comparison vs baseline||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
91522154|NCT00514683|182919352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.052||0.853|TWO_SIDED|95.0|-0.086|0.118||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.118|-0.086|0.8530
91522155|NCT00514683|182919352|SUPERIORITY_OR_OTHER|||||||0.7558||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.7558
91522156|NCT00514683|182919352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.792|TWO_SIDED|95.0|-0.119|0.08||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.080|-0.119|0.7920
91522157|NCT00514683|182919352|SUPERIORITY_OR_OTHER|||||||0.6991||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.6991
91522158|NCT00514683|182919352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.051||0.853|TWO_SIDED|95.0|-0.071|0.128||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.128|-0.071|0.8530
91522159|NCT00514683|182919352|SUPERIORITY_OR_OTHER|||||||0.5736||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.5736
91522160|NCT00514683|182919352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.053||0.0639|TWO_SIDED|95.0|0.027|0.235||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.235|0.027|0.0639
91522161|NCT00514683|182919352|SUPERIORITY_OR_OTHER|||||||0.0136||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.0136
91522162|NCT00514683|182919353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.43|STANDARD_ERROR_OF_MEAN|1.312||0.2774|TWO_SIDED|95.0|-1.15|4.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.01|-1.15|0.2774
91522163|NCT00514683|182919353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.312||0.4014|TWO_SIDED|95.0|-1.48|3.68|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.68|-1.48|0.4014
91522164|NCT00514683|182919353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|1.324||0.0314|TWO_SIDED|95.0|0.26|5.46|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.46|0.26|0.0314
91522165|NCT00514683|182919353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|1.319||0.0002|TWO_SIDED|95.0|2.37|7.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.56|2.37|0.0002
91522166|NCT00514683|182919354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.046||0.3644|TWO_SIDED|95.0|-0.05|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.05|0.3644
91522167|NCT00514683|182919354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.046||0.4525|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.06|0.4525
91522168|NCT00514683|182919354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0471|TWO_SIDED|95.0|0.0|0.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.18|0.00|0.0471
91522169|NCT00514683|182919354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0004|TWO_SIDED|95.0|0.08|0.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.26|0.08|0.0004
91522170|NCT00514683|182919355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|1.702||0.592|TWO_SIDED|95.0|-2.43|4.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.26|-2.43|0.5920
91522171|NCT00514683|182919355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.702||0.6155|TWO_SIDED|95.0|-2.49|4.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.20|-2.49|0.6155
91613987|NCT00431847|183121846|SUPERIORITY_OR_OTHER||Chi-Squared|2.49||||0.4772|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4772
91522172|NCT00514683|182919355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81|STANDARD_ERROR_OF_MEAN|1.716||0.0271|TWO_SIDED|95.0|0.43|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.43|0.0271
91649129|NCT01827371|183190791|SUPERIORITY_OR_OTHER|||||||0.6171|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm swelling' Arm A) = Pr('Underarm swelling' Arm D) H1: Pr('Underarm swelling' Arm A) not = Pr('Underarm swelling' Arm D)"||||0.6171
91596145|NCT04869345|183083010|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.792|TWO_SIDED|95.0|-1.63|2.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.13|-1.63|0.792
91596146|NCT04869345|183083010|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.95||0.209|TWO_SIDED|95.0|-0.69|3.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.09|-0.69|0.209
91596147|NCT04869345|183083010|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.66||0.151|TWO_SIDED|95.0|-0.35|2.26||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.26|-0.35|0.151
91596148|NCT04869345|183083011|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.47||0.601|TWO_SIDED|95.0|-2.14|3.69||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.69|-2.14|0.601
91596149|NCT04869345|183083011|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|1.49||0.269|TWO_SIDED|95.0|-4.6|1.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.29|-4.60|0.269
91596150|NCT04869345|183083011|SUPERIORITY||Mean Difference (Net)|-2.43|STANDARD_ERROR_OF_MEAN|1.53||0.116|TWO_SIDED|95.0|-5.47|0.61||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.61|-5.47|0.116
91596151|NCT04869345|183083012|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.479|TWO_SIDED|95.0|-0.1|0.22||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.22|-0.10|0.479
91649130|NCT01827371|183190791|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Redness at Injection Site' Arm A) = Pr('Redness at Injection Site' Arm D) H1: Pr('Redness at Injection Site' Arm A) not = Pr('Redness at Injection Site' Arm D)"||||<0.0001
91522173|NCT00514683|182919355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.47|STANDARD_ERROR_OF_MEAN|1.71||0.0015|TWO_SIDED|95.0|2.11|8.83|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.83|2.11|0.0015
91522174|NCT00514683|182919356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|1.692||0.5601|TWO_SIDED|95.0|-2.34|4.31||ANCOVA with fixed terms for treatment, baseline, region.|ANCOVA||Mean difference to placebo is calculated. Negative change indicates worsening.|||4.31|-2.34|0.5601
91522175|NCT00514683|182919356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.694||0.6366|TWO_SIDED|95.0|-2.53|4.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.13|-2.53|0.6366
91596152|NCT04869345|183083012|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.04|0.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.29|-0.04|0.126
91596153|NCT04869345|183083012|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.457|TWO_SIDED|95.0|-0.12|0.25||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.25|-0.12|0.457
91596154|NCT04869345|183083013|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.389|TWO_SIDED|95.0|-0.15|0.38||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.38|-0.15|0.389
91596155|NCT04869345|183083013|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13||0.157|TWO_SIDED|95.0|-0.07|0.46||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.46|-0.07|0.157
91596156|NCT04869345|183083013|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.593|TWO_SIDED|95.0|-0.21|0.36||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.36|-0.21|0.593
91613988|NCT00431847|183121846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07724|STANDARD_ERROR_OF_MEAN|0.1503||0.6077|TWO_SIDED|95.0|-0.2184|0.3729|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3729|-0.2184|0.6077
91649131|NCT01827371|183190791|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Swelling at Injection Site' Arm A) = Pr('Swelling at Injection Site' Arm D) H1: Pr('Swelling at Injection Site' Arm A) not = Pr('Swelling at Injection Site' Arm D)"||||0.0050
91784100|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1366||||0.1644|TWO_SIDED|95.0|-0.0574|0.3307|||Mixed model for repeated measures|||For parietal lobe||0.3307|-0.0574|0.1644
91613989|NCT00431847|183121846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2004|STANDARD_ERROR_OF_MEAN|0.2194||0.3616|TWO_SIDED|95.0|-0.2311|0.6319|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.6319|-0.2311|0.3616
91784101|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1259||||0.1509|TWO_SIDED|95.0|-0.0471|0.2989|||Mixed model for repeated measures|||For Posterior temporal lobe||0.2989|-0.0471|0.1509
91784102|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1339||||0.2041|TWO_SIDED|95.0|-0.0747|0.3424|||Mixed model for repeated measures|||For cerebellum||0.3424|-0.0747|0.2041
91784103|NCT00265148|183448625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1094||||0.1445|TWO_SIDED|95.0|-0.0385|0.2572|||Mixed model for repeated measures|||For medial temporal lobe||0.2572|-0.0385|0.1445
91784104|NCT00265148|183448626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1211||||0.2251|TWO_SIDED|95.0|-0.0763|0.3185|||Mixed model for repeated measures|||At Month 1||0.3185|-0.0763|0.2251
91784105|NCT00265148|183448626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0893||||0.2497|TWO_SIDED|95.0|-0.0643|0.243|||Mixed model for repeated measures|||For Month 6||0.2430|-0.0643|0.2497
91784106|NCT00265148|183448627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.11||||0.7618|TWO_SIDED|95.0|-0.59|0.8|||Repeated measure mixed model|||For BSR test , Month 1||0.80|-0.59|0.7618
91784107|NCT00265148|183448627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.06||||0.835|TWO_SIDED|95.0|-0.53|0.66|||Repeated measure mixed model|||For BSR test, Month 6||0.66|-0.53|0.8350
91596157|NCT04869345|183083014|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.933|TWO_SIDED|95.0|-0.26|0.24||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.24|-0.26|0.933
91596158|NCT04869345|183083014|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.642|TWO_SIDED|95.0|-0.19|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|-0.19|0.642
91596159|NCT04869345|183083014|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.577|TWO_SIDED|95.0|-0.18|0.32||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.32|-0.18|0.577
91596160|NCT04869345|183083015|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.11||0.403|TWO_SIDED|95.0|-0.32|0.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.13|-0.32|0.403
91596161|NCT04869345|183083015|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.11||0.062|TWO_SIDED|95.0|-0.44|0.01||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.01|-0.44|0.062
91596162|NCT04869345|183083015|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.269|TWO_SIDED|95.0|-0.33|0.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.09|-0.33|0.269
91649132|NCT01827371|183190791|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Any Solicited Local Reaction' Arm A) = Pr('Any Solicited Local Reaction' Arm D) H1: Pr('Any Solicited Local Reaction' Arm A) not = Pr('Any Solicited Local Reaction' Arm D)"||||0.0012
91709307|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.271|TWO_SIDED|95.0|-0.48|0.13|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μ||0.13|-0.48|0.271
91709308|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.725|TWO_SIDED|95.0|-0.51|0.36|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.36|-0.51|0.725
91709309|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.559|TWO_SIDED|95.0|-0.53|0.28|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.28|-0.53|0.559
91522176|NCT00514683|182919356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|1.702||0.0246|TWO_SIDED|95.0|0.49|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.49|0.0246
91649133|NCT01827371|183190792|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.76|||||TWO_SIDED|98.33|0.37|1.15||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||1.15|0.37|
91784108|NCT00265148|183448627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14||||0.6735|TWO_SIDED|95.0|-0.78|0.51|||Repeated measure mixed model|||For BSR test, Month 12||0.51|-0.78|0.6735
91522177|NCT00514683|182919356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.44|STANDARD_ERROR_OF_MEAN|1.7||0.0015|TWO_SIDED|95.0|2.1|8.78|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.78|2.10|0.0015
91596163|NCT04869345|183083016|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|0.07|0.33||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.33|0.07|0.003
91596164|NCT04869345|183083016|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|0.05|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|0.05|0.006
91596165|NCT04869345|183083016|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.796|TWO_SIDED|95.0|-0.15|0.12||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.12|-0.15|0.796
91613586|NCT01899144|183121466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0062|TWO_SIDED|95.0|0.08|0.45|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.45|0.08|0.0062
91784109|NCT00265148|183448628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.7045|TWO_SIDED|95.0|-0.44|0.3|||Repetaed measure mixed model|||For Month 1||0.30|-0.44|0.7045
91784110|NCT00265148|183448628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.8181|TWO_SIDED|95.0|-0.4|0.32|||Repeated measure mixed model|||For Month 6||0.32|-0.40|0.8181
91784111|NCT00265148|183448628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.7688|TWO_SIDED|95.0|-0.71|0.53|||Repeated measure mixed model|||AT Month 12||0.53|-0.71|0.7688
91784112|NCT00265148|183448628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.681|TWO_SIDED|95.0|-0.4|0.26|||Repeated measure mixed model|||Overall||0.26|-0.40|0.6810
91596166|NCT04869345|183083017|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.758|TWO_SIDED|95.0|-0.03|0.05||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.05|-0.03|0.758
91596167|NCT04869345|183083017|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.88|TWO_SIDED|95.0|-0.04|0.04||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.04|-0.04|0.880
91596168|NCT04869345|183083017|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.652|TWO_SIDED|95.0|-0.05|0.03||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.03|-0.05|0.652
91596169|NCT01500759|183083043|OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0||||||||||||
91596170|NCT01500759|183083044|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0||||||||||||
91596171|NCT01500759|183083045|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|||||||||||||
91596172|NCT01500759|183083046|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0||||||||||||
91596173|NCT01290874|183083047|SUPERIORITY|||||||0.31|||||||Log Rank|||||||0.31
91596174|NCT02813551|183083121|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||||1.10|0.53|
91596175|NCT02813551|183083122|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.3||||||||3.3|0.4|
91596176|NCT02813551|183083123|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.3|28.0||||||||28|0.3|
91596177|NCT02813551|183083124|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.3||||||||1.3|1.0|
91596178|NCT02813551|183083127|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.2||||||||1.2|1.0|
91596179|NCT02813551|183083128|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|1.9||||||||1.9|0.5|
91596180|NCT02813551|183083129|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.1|2.9||||||||2.9|0.1|
91596181|NCT00102960|183083134|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.02|TWO_SIDED|95.0|0.38|0.93|||Regression, Cox|||Statistical analysis compares early therapy 40 weeks (ART-40W) relative to deferred therapy (ART-Def)||0.93|0.38|0.02
91596182|NCT00102960|183083134|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.002|TWO_SIDED|95.0|0.27|0.76|||Regression, Cox|||Statistical analysis compares early therapy 96 weeks (ART-96W) relative to deferred therapy (ART-Def)||0.76|0.27|0.002
91709310|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.47||||0.019|TWO_SIDED|95.0|-0.87|-0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||-0.08|-0.87|0.019
91596183|NCT00102960|183083139|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Cummulative Probability|0.13||||0.03|TWO_SIDED|95.0|0.01|0.25|||Proportion test|||Relative to ART-Def, ART-40W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.25|0.01|0.03
91596184|NCT00102960|183083139|SUPERIORITY||Kaplan-Meier Cummulative Probability|0.2||||0.0006|TWO_SIDED|95.0|0.09|0.31|||Proportion test|||Relative to ART-Def, ART-96W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.31|0.09|0.0006
91709311|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.348|TWO_SIDED|95.0|-0.61|0.21|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.21|-0.61|0.348
91709312|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.03||||0.855|TWO_SIDED|95.0|-0.35|0.29|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.29|-0.35|0.855
91784113|NCT00265148|183448632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.8593|TWO_SIDED|95.0|-2.38|1.99|||Repeated measure mixed model|||At Month 1||1.99|-2.38|0.8593
91784114|NCT00265148|183448632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.44||||0.3201|TWO_SIDED|95.0|-1.43|4.32|||Repeated measure mixed model|||At Month 6||4.32|-1.43|0.3201
91596185|NCT00102960|183083140|SUPERIORITY_OR_OTHER_LEGACY||Rate per 100 person years|0.0|||<|0.0001|TWO_SIDED|||||This p-value compares event rates per 100 person-years across the three arms|Poisson Regression|||The CHER study compared Grade 3 or 4 clinical event rates per 100 person-years between the three arms using Poisson regression modeling over the study duration of 4.8 years.|The rates per 100 person-years were 33.8 (Arm 1), 21.6 (Arm 2) and 16 (Arm 3)|||<0.0001
91596186|NCT00102960|183083141|SUPERIORITY||Rate per 100 person years|0.0||||0.46|TWO_SIDED||||||Poisson regression|||The event rates per 100 person years were compared across the three arms|The laboratory events per 100 person years across the three arms were: 7 (Deferred arm), 8.1 (early therapy for 40 weeks) and 6 (early therapy for 96 weeks).|||0.46
91596187|NCT00102960|183083144|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.011|TWO_SIDED|95.0|0.27|0.84|||Regression, Cox||Hazard rate reported above compares early therapy 40 weeks relative to the deferred therapy arm.|The analysis compares ART-40W relative to the ART-Def arm.||0.84|0.27|0.011
91596188|NCT00102960|183083144|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34||||0.0009|TWO_SIDED|95.0|0.18|0.64|||Regression, Cox||The hazard ratio compares ART-96W relative to the ART-Def arm.|The analysis compares ART-96 Weeks relative to ART-Deferred||0.64|0.18|0.0009
91596189|NCT00102960|183083146|SUPERIORITY||Count of days|0.0||||0.004|TWO_SIDED|||||The p-value here compares the days spent in hospital across the three arms|Poisson regression||||The total number of days/count of days: 1018 (Arm 1), 533 (Arm 2) and 414 (Arm 3) were compared across the three groups by Poisson regression analysis.|||0.004
91596190|NCT00102960|183083147|SUPERIORITY||Hazard Ratio (HR)|0.562||||0.0021|TWO_SIDED|95.0|0.389|0.811|||Regression, Cox|||||0.811|0.389|0.0021
91596191|NCT00102960|183083147|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.0038|TWO_SIDED|95.0|0.405|0.84|||Regression, Cox|||||0.840|0.405|0.0038
91596192|NCT03040999|183083148|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1997|TWO_SIDED|95.0|0.71|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.15|0.71|0.1997
91596193|NCT03040999|183083151|OTHER||Difference in Least squares mean|-4.24||||0.0015|TWO_SIDED|95.0|-6.85|-1.63|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||-1.63|-6.85|0.0015
91596194|NCT03040999|183083152|OTHER||Difference in Least squares mean|-0.51||||0.7719|TWO_SIDED|95.0|-3.98|2.96|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.96|-3.98|0.7719
91596195|NCT03040999|183083153|OTHER||Difference in Least squares mean|-1.29||||0.45|TWO_SIDED|95.0|-4.64|2.06|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.06|-4.64|0.4500
91596196|NCT03040999|183083154|OTHER||Difference in Least squares mean|1.29||||0.3524|TWO_SIDED|95.0|-1.43|4.02|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||4.02|-1.43|0.3524
91709313|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.203|TWO_SIDED|95.0|-0.5|0.11|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.11|-0.50|0.203
91522178|NCT00514683|182919357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||0.7543|TWO_SIDED|95.0|0.506|1.637|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.637|0.506|0.7543
91596197|NCT03040999|183083155|OTHER||Difference in Least squares mean|-2.05||||0.0963|TWO_SIDED|95.0|-4.47|0.37|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||0.37|-4.47|0.0963
91596198|NCT03040999|183083156|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0429|TWO_SIDED|95.0|0.68|1.03||P-value crossing boundary of 0.0242 required for statistical significance.|Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.03|0.68|0.0429
91596199|NCT01964352|183083211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.293|0.369|||Mixed Effects Model for Repeated Measure|||||0.369|0.293|<0.0001
91709314|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.44||||0.055|TWO_SIDED|95.0|-0.89|0.01|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.01|-0.89|0.055
91784115|NCT00265148|183448632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.18||||0.2627|TWO_SIDED|95.0|-1.68|6.04|||Repeated measure mixed model|||At Month 12||6.04|-1.68|0.2627
91784116|NCT00265148|183448632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.14||||0.3633|TWO_SIDED|95.0|-1.35|3.64|||Repeated measure mixed model|||For overall period||3.64|-1.35|0.3633
91784117|NCT00265148|183448633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.5647|TWO_SIDED|95.0|-0.48|0.26|||Repetaed measure mixed model|||For overall period||0.26|-0.48|0.5647
91784118|NCT00265148|183448633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9935|TWO_SIDED|95.0|-0.46|0.46|||Repeated measure mixed model|||For Month 1||0.46|-0.46|0.9935
91784119|NCT00265148|183448633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22||||0.3794|TWO_SIDED|95.0|-0.72|0.28|||Repeated measure mixed model|||At Month 6||0.28|-0.72|0.3794
91784120|NCT00265148|183448633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.7357|TWO_SIDED|95.0|-0.7|0.49|||Repeated measure mixed model|||At Month 12||0.49|-0.70|0.7357
91596200|NCT01964352|183083211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.075|0.148|||Mixed Effects Model for Repeated Measure|||||0.148|0.075|<0.0001
91596201|NCT01964352|183083211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.262|0.337|||Mixed Effects Model for Repeated Measure|||||0.337|0.262|<0.0001
91596202|NCT01964352|183083211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.044|0.116|||Mixed Effects Model for Repeated Measure|||||0.116|0.044|<0.0001
91596203|NCT01964352|183083211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.181|0.258|||Mixed Effects Model for Repeated Measure|||||0.258|0.181|<0.0001
91596204|NCT01964352|183083211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018||0.0872|TWO_SIDED|95.0|-0.005|0.067|||Mixed Effects Model for Repeated Measure|||||0.067|-0.005|0.0872
91596205|NCT01964352|183083212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0124|0.2|||Mixed Effects Model for Repeated Measure|||||0.200|0.0124|<0.0001
91596206|NCT01964352|183083212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.019||0.1381|TWO_SIDED|95.0|-0.009|0.066|||Mixed Effects Model for Repeated Measure|||||0.066|-0.009|0.1381
91596207|NCT01964352|183083212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.113|0.188|||Mixed Effects Model for Repeated Measure|||||0.188|0.113|<0.0001
91596208|NCT01964352|183083212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.3872|TWO_SIDED|95.0|-0.021|0.054|||Mixed Effects Model for Repeated Measure|||||0.054|-0.021|0.3872
91596209|NCT01964352|183083212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.096|0.172|||Mixed Effects Model for Repeated Measure|||||0.172|0.096|<0.0001
91596210|NCT01964352|183083212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.019||0.5333|TWO_SIDED|95.0|-0.025|0.049|||Mixed Effects Model for Repeated Measure|||||0.049|-0.025|0.5333
91522179|NCT00514683|182919357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.6704|TWO_SIDED|95.0|0.631|2.045|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.045|0.631|0.6704
91596211|NCT01964352|183083213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.894|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-6.904|-2.884|||Mixed Effects Model for Repeated Measure|||||-2.884|-6.904|<0.0001
91596212|NCT01964352|183083213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.493|STANDARD_ERROR_OF_MEAN|1.009||0.0136|TWO_SIDED|95.0|-4.473|-0.513|||Mixed Effects Model for Repeated Measure|||||-0.513|-4.473|0.0136
91596213|NCT01964352|183083213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.122|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-6.129|-2.114|||Mixed Effects Model for Repeated Measure|||||-2.114|-6.129|<0.0001
91596214|NCT01964352|183083213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.721|STANDARD_ERROR_OF_MEAN|1.008||0.088|TWO_SIDED|95.0|-3.698|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|-3.698|0.0880
91596215|NCT01964352|183083213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.401|STANDARD_ERROR_OF_MEAN|1.029||0.0198|TWO_SIDED|95.0|-4.419|-0.382|||Mixed Effects Model for Repeated Measure|||||-0.382|-4.419|0.0198
91596216|NCT01964352|183083213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772|STANDARD_ERROR_OF_MEAN|1.003||0.4415|TWO_SIDED|95.0|-2.741|1.196|||Mixed Effects Model for Repeated Measure|||||1.196|-2.741|0.4415
91596217|NCT01964352|183083214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.157|0.282|||Mixed Effects Model for Repeated Measure|||||0.282|0.157|<0.0001
91596218|NCT01964352|183083214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.032||0.5052|TWO_SIDED|95.0|-0.041|0.084|||Mixed Effects Model for Repeated Measure|||||0.084|-0.041|0.5052
91596219|NCT01964352|183083214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.146|0.271|||Mixed Effects Model for Repeated Measure|||||0.271|0.146|<0.0001
91596220|NCT01964352|183083214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7566|TWO_SIDED|95.0|-0.052|0.072|||Mixed Effects Model for Repeated Measure|||||0.072|-0.052|0.7566
91596221|NCT01964352|183083214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.136|0.261|||Mixed Effects Model for Repeated Measure|||||0.261|0.136|<0.0001
91596222|NCT01964352|183083214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.032||0.7199|TWO_SIDED|95.0|-0.051|0.073|||Mixed Effects Model for Repeated Measure|||||0.073|-0.051|0.7199
91596223|NCT01964352|183083215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.052|STANDARD_ERROR_OF_MEAN|0.273|<|0.0001|TWO_SIDED|95.0|1.516|2.588|||Mixed Effects Model for Repeated Measure|||||2.588|1.516|<0.0001
91596224|NCT01964352|183083215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.607|STANDARD_ERROR_OF_MEAN|0.27||0.0246|TWO_SIDED|95.0|0.078|1.137|||Mixed Effects Model for Repeated Measure|||||1.137|0.078|0.0246
91784121|NCT00265148|183448636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4971.6||||0.6299|TWO_SIDED|95.0|-255515.6|15572.4|||Repeated measure mixed model|Arithmetic means have been presented; however, statistical analysis is based upon the least square (LS) means||At Month 6||15572.4|-255515.6|0.6299
91784122|NCT00265148|183448636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12223.0||||0.2184|TWO_SIDED|95.0|-7450.6|31896.5|||Repeated measure mixed model|||At Month 12||31896.5|-7450.6|0.2184
91596225|NCT01964352|183083215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.952|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|1.417|2.487|||Mixed Effects Model for Repeated Measure|||||2.487|1.417|<0.0001
91596226|NCT01964352|183083215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.507|STANDARD_ERROR_OF_MEAN|0.269||0.0599|TWO_SIDED|95.0|-0.021|1.035|||Mixed Effects Model for Repeated Measure|||||1.035|-0.021|0.0599
91596227|NCT01964352|183083215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.445|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|0.907|1.983|||Mixed Effects Model for Repeated Measure|||||1.983|0.907|<0.0001
91596228|NCT01964352|183083215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.268||0.7081|TWO_SIDED|95.0|-0.425|0.626|||Mixed Effects Model for Repeated Measure|||||0.626|-0.425|0.7081
91596229|NCT01964352|183083216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.457|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.39|0.524|||Mixed Effects Model for Repeated Measure|||||0.524|0.390|<0.0001
91596230|NCT01964352|183083216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.095|0.225|||Mixed Effects Model for Repeated Measure|||||0.225|0.095|<0.0001
91596231|NCT01964352|183083216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.331|0.465|||Mixed Effects Model for Repeated Measure|||||0.465|0.331|<0.0001
91596232|NCT01964352|183083216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.033||0.0023|TWO_SIDED|95.0|0.036|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.036|0.0023
91596233|NCT01964352|183083216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.229|0.365|||Mixed Effects Model for Repeated Measure|||||0.365|0.229|<0.0001
91784123|NCT00265148|183448637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0129|TWO_SIDED|95.0|-1.0|-0.1|||Repeated measure mixed model|||For Month 6||-0.1|-1.0|0.0129
91596234|NCT01964352|183083216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.033||0.0701|TWO_SIDED|95.0|-0.005|0.123|||Mixed Effects Model for Repeated Measure|||||0.123|-0.005|0.0701
91613587|NCT01899144|183121466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6342|TWO_SIDED|95.0|-0.23|0.14||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.14|-0.23|0.6342
91522180|NCT00514683|182919357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.657||||0.1649|TWO_SIDED|95.0|0.363|1.189|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.189|0.363|0.1649
91522181|NCT00514683|182919357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.415||||0.0041|TWO_SIDED|95.0|0.227|0.757|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.757|0.227|0.0041
91522182|NCT00514683|182919358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.5882|TWO_SIDED|95.0|0.526|3.102|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.102|0.526|0.5882
91522183|NCT00514683|182919358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.0653|TWO_SIDED|95.0|0.078|1.081|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.081|0.078|0.0653
91709315|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.104|TWO_SIDED|95.0|-0.82|0.08|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.08|-0.82|0.104
91784124|NCT00265148|183448637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.5607|TWO_SIDED|95.0|-1.0|0.6|||Repeated measure mixed model|||For Month 12||0.6|-1.0|0.5607
91784125|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1154||||0.28|TWO_SIDED|95.0|-0.0967|0.3275|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status positive||0.3275|-0.0967|0.2800
91784126|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1337||||0.4159||95.0|-0.1931|0.4605|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status negative||0.4605|-0.1931|0.4159
91784127|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1491||||0.2158|TWO_SIDED|95.0|-0.0897|0.3878|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status positive||0.3878|-0.0897|0.2158
91784128|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2346||||0.2087|TWO_SIDED|95.0|-0.135|0.6042|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status negative||0.6042|-0.1350|0.2087
91784129|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1233||||0.3064|TWO_SIDED|95.0|-0.1162|0.3628|||Repeated measure mixed model|||For Frontal lobe, APOE Epsilon-4 status positive||0.3628|-0.1162|0.3064
91784130|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1734||||0.35|TWO_SIDED|95.0|-0.1952|0.542|||Repeated measure mixed model|||For Frontal lobe APOE Epsilon-4 status negative||0.5420|-0.1952|0.3500
91784131|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13||||0.2487|TWO_SIDED|95.0|-0.0937|0.3538|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status positive||0.3538|-0.0937|0.2487
91784132|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1038||||0.5521|TWO_SIDED|95.0|-0.244|0.4516|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status negative||0.4516|-0.2440|0.5521
91784133|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1384||||0.176|TWO_SIDED|95.0|-0.064|0.3409|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status positive||0.3409|-0.0640|0.1760
91784134|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0837||||0.5952|TWO_SIDED|95.0|-0.2303|0.3978|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status negative||0.3978|-0.2303|0.5952
91784135|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0847||||0.4025|TWO_SIDED|95.0|-0.1169|0.2863|||Repeated measure mixed model|||For Cerebellum, APOE Epsilon-4 status positive||0.2863|-0.1169|0.4025
91784136|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.3081|TWO_SIDED|95.0|-0.1458|0.453|||Repeated measure mixed model95|||For Cerebellum, APOE Epsilon-4 status negative||0.4530|-0.1458|0.3081
91784137|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0839||||0.2964|TWO_SIDED|95.0|-0.0758|0.2436|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status positive||0.2436|-0.0758|0.2964
91784138|NCT00265148|183448649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.2101|TWO_SIDED|95.0|-0.0892|0.3963|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status negative||0.3963|-0.0892|0.2101
91784139|NCT04780919|183448654|SUPERIORITY|||||||0.722||||||p-value is adjusted to comparison between the Group A and Group B at 3 weeks follow-up after the last application.|Two-way ANOVA|||The Group A will have significantly decreased Cross Section Area compared to Group B at 3 weeks follow up after last application.||||0.722
91784140|NCT04780919|183448655|SUPERIORITY|||||||0.096||||||p-value is adjusted to comparison between the Group A and Group B in the timeframe of the last application.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B in the timeframe of the last application compared to baseline.||||0.096
91784141|NCT04780919|183448656|SUPERIORITY|||||||0.035||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.035
91784142|NCT04780919|183448657|SUPERIORITY|||||||0.171||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum of ankle dorsiflexion range of motion will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.171
91784143|NCT04780919|183448660|SUPERIORITY|||||||0.104||||||p-value is adjusted to comparison between the Group A and Group B in 3 weeks follow up after the last application.|Two-way ANOVA|||The VISA-A score will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.104
91596235|NCT02831673|183083217|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 greater than -10%.|Adjusted difference in proportion|-2.6|||||TWO_SIDED|95.0|-6.7|1.5|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=versus \[vs.\]\>100,000 c/mL) and cluster of differentiation 4+ (CD4+) cell count (\<= vs. \>200 cells per cubic millimeter).|||1.5|-6.7|
91784144|NCT04075734|183448716|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.59
91784145|NCT04075734|183448716|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.003
91784146|NCT04075734|183448717|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
91784147|NCT04075734|183448718|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.07
91784148|NCT04075734|183448719|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.2
91784149|NCT04075734|183448720|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.006
91784150|NCT04075734|183448721|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.86
91784151|NCT04075734|183448722|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
91596236|NCT02831673|183083218|OTHER||Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-4.2|3.4|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=vs.\>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter).|||3.4|-4.2|
91596237|NCT02831673|183083219|OTHER||Adjusted difference in proportion|-4.9|||||TWO_SIDED|95.0|-9.8|0.0|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||0.0|-9.8|
91596238|NCT02831673|183083220|OTHER||Adjusted difference in proportion|-3.6|||||TWO_SIDED|95.0|-9.4|2.1|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.1|-9.4|
91596239|NCT02831673|183083221|OTHER||Hazard Ratio (HR)|1.0||||0.658|TWO_SIDED|95.0|0.86|1.16||The generalized Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalized Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.16|0.86|0.658
91596240|NCT02831673|183083225|OTHER||Mean Difference (Net)|17.1||||0.206|TWO_SIDED|95.0|-9.4|43.6|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||43.6|-9.4|0.206
91596241|NCT02831673|183083225|OTHER||Mean Difference (Net)|4.6||||0.754|TWO_SIDED|95.0|-23.9|33.0|||Mixed Model Repeated Measures (MMRM)||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||33.0|-23.9|0.754
91784152|NCT04075734|183448723|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of intervention over time.||||||0.02
91596242|NCT02831673|183083226|OTHER||Mean Difference (Net)|10.8||||0.5|TWO_SIDED|95.0|-20.7|42.4|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||42.4|-20.7|0.500
91596243|NCT02831673|183083227|OTHER||Mean Difference (Net)|-1.4||||0.934|TWO_SIDED|95.0|-34.2|31.5|||Mixed Model Repeated Measures (MMRM)||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||31.5|-34.2|0.934
91596244|NCT02831673|183083238|OTHER||Mean Difference (Net)|-0.02||||0.025|TWO_SIDED|95.0|-0.04|0.0|||Mixed Model Repeated Measures||Serum Cystatin C, Week 24|||0.00|-0.04|0.025
91596245|NCT02831673|183083238|OTHER||Mean Difference (Net)|-0.03||||0.001|TWO_SIDED|95.0|-0.05|-0.01|||Mixed Model Repeated Measures||Serum Cystatin C, Week 48|||-0.01|-0.05|0.001
91596246|NCT02831673|183083238|OTHER||Mean Difference (Net)|-0.3||||0.683|TWO_SIDED|95.0|-1.6|1.0|||Mixed Model Repeated Measures||Serum RBP, Week 24|||1.0|-1.6|0.683
91596247|NCT02831673|183083238|OTHER||Mean Difference (Net)|-0.1||||0.93|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Serum RBP, Week 48|||1.2|-1.4|0.930
91649134|NCT01827371|183190792|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.3|||||TWO_SIDED|98.33|-0.06|0.67||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.67|-0.06|
91596248|NCT02831673|183083239|OTHER||Mean Difference (Net)|-0.02||||0.009|TWO_SIDED|95.0|-0.04|-0.01|||Mixed Model Repeated Measures||Week 96. Serum Cystatin C.|||-0.01|-0.04|0.009
91784153|NCT04075734|183448724|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.29
91596249|NCT02831673|183083240|OTHER||Mean Difference (Net)|-0.01||||0.108|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Week 144. Serum Cystatin C.|||-0.00|-0.03|0.108
91596250|NCT02831673|183083243|OTHER||Mean Difference (Net)|2.2||||0.011|TWO_SIDED|95.0|0.5|4.0|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 24|||4.0|0.5|0.011
91596251|NCT02831673|183083243|OTHER||Mean Difference (Net)|2.8|||<|0.001|TWO_SIDED|95.0|1.2|4.5|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 48|||4.5|1.2|<0.001
91596252|NCT02831673|183083243|OTHER||Mean Difference (Net)|3.2|||<|0.001|TWO_SIDED|95.0|1.6|4.8|||Mixed Model Repeated Measures||GFR-creatinine adjusted, Week 24|||4.8|1.6|<0.001
91784154|NCT04075734|183448725|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.13
91596253|NCT02831673|183083243|OTHER||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|5.1|||Mixed Model Repeated Measures||GFR- creatinine adjusted, Week 48|||5.1|2.0|<0.001
91784155|NCT04075734|183448726|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
91784156|NCT04075734|183448727|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
91784157|NCT04075734|183448728|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.66
91784158|NCT04075734|183448729|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.15
91784159|NCT02433080|183448733|OTHER||Mean Difference (Net)|6.4||||0.05|TWO_SIDED|95.0|-3.6|16.5|||ANCOVA|||This statistical analysis applies for the outcomes 2-8.||16.5|-3.6|0.05
91784160|NCT03462511|183448744|SUPERIORITY||Mean Difference (Net)|2.4||||0.067|TWO_SIDED|||||Independent variables: study month, study group, their interactions and a person-level random intercept to incorporate clustering.|Regression, Linear|||Based on estimated effect size from our prior feasibility trial, the target enrollment was 87 dyads plus additional 20% to account for attrition before Month 6 or blood transfusions or acute illness rendering HbF levels inaccurate.||||0.067
91784161|NCT03462511|183448745|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||We compared the difference in proportion of days covered by hydroxyurea at two timepoints: (1) from the year prior to study entry to 6 months (the end of the active intervention phase of the trial) and (2) from 6 months to 12 months (the sustainability phase of the trial).||||0.60
91784162|NCT03462511|183448746|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||We hypothesized that, compared to the control group, generic quality of life (QOL) for youth in the intervention group would improve from baseline to 9 months.||||<0.001
91784163|NCT03462511|183448746|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test generic quality of life (QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.04|||||||Regression, Linear|||We hypothesized that the improvement in quality of life experienced by the intervention group would be sustained from month 9 to month 12.||||0.04
91784164|NCT03462511|183448747|SUPERIORITY|||||||0.47|||||||Regression, Linear|||We hypothesized that, compared to the control group, sickle cell disease specific quality of life (SC-QOL) for youth in the intervention group would improve from baseline to 9 months.||||0.47
91784165|NCT03462511|183448747|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test sickle cell disease specific quality of life (SC-QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.045|||||||Regression, Linear|||We hypothesized that the improvement in sickle cell disease specific quality of life (SC-QOL) experienced by the intervention group would be sustained from month 9 to month 12.||||0.045
91784166|NCT03462511|183448748|SUPERIORITY|||||||0.002|||||||Regression, Linear|||We hypothesized that, compared to the control group, responsibility for self-management concordance for youth-caregiver dyads in the intervention group would improve from baseline to 6 months.||||0.002
91784167|NCT03462511|183448748|NON_INFERIORITY|50% of the standard deviation was used as the non-inferiority margin. For this test youth caregiver concordance for self-management responsibility scores for months 0-6 (efficacy period) were compared to months 6-12 (sustainability period).||||||0.23|||||||Regression, Linear|||We hypothesized that the improvement in concordance between youth and caregivers for self-management responsibility experienced by the intervention group would be sustained from month 6 to month 12.||||0.23
91784168|NCT03001817|183448756|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784169|NCT03001817|183448757|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784170|NCT03001817|183448758|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
91784171|NCT03001817|183448759|SUPERIORITY|||||||0.5443|||||||Hodges-Lehmann method|||||||0.5443
91596254|NCT02831673|183083246|OTHER||Mean Difference (Net)|-3.19|||<|0.001|TWO_SIDED|95.0|-4.62|-1.75|||Mixed Model Repeated Measures||Week 24|||-1.75|-4.62|<0.001
91784172|NCT03001817|183448760|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
91784173|NCT03001817|183448761|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784174|NCT03001817|183448762|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784175|NCT03001817|183448763|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784176|NCT03001817|183448764|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784177|NCT03001817|183448765|SUPERIORITY|||||||0.4939|||||||Hodges-Lehmann method|||||||0.4939
91784178|NCT03001817|183448766|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784179|NCT03001817|183448767|SUPERIORITY|||||||0.8371|||||||Hodges-Lehmann method|||||||0.8371
91784180|NCT03001817|183448768|SUPERIORITY|||||||0.3415|||||||Hodges-Lehmann method|||||||0.3415
91784181|NCT03001817|183448769|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784182|NCT03001817|183448770|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784183|NCT03001817|183448771|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784184|NCT03001817|183448772|SUPERIORITY|||||||0.7442|||||||Hodges-Lehmann method|||||||0.7442
91784185|NCT03001817|183448773|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91596255|NCT02831673|183083246|OTHER||Mean Difference (Net)|-3.22|||<|0.001|TWO_SIDED|95.0|-4.54|-1.91|||Mixed Model Repeated Measures||Week 48|||-1.91|-4.54|<0.001
91784186|NCT03001817|183448774|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91596256|NCT02831673|183083247|OTHER||Mean Difference (Net)|-3.34|||<|0.001|TWO_SIDED|95.0|-4.96|-1.72|||Mixed Model Repeated Measures||Week 96. Serum or Plasma creatinine|||-1.72|-4.96|<0.001
91784187|NCT03001817|183448775|SUPERIORITY|||||||0.0374|||||||Hodges-Lehmann method|||||||0.0374
91784188|NCT03001817|183448776|SUPERIORITY|||||||0.7429|||||||Hodges-Lehmann method|||||||0.7429
91784189|NCT03001817|183448777|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784190|NCT03001817|183448778|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784191|NCT03001817|183448779|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784192|NCT03001817|183448780|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91596257|NCT02831673|183083248|OTHER||Mean Difference (Net)|-2.98|||<|0.001|TWO_SIDED|95.0|-4.57|-1.4|||Mixed Model Repeated Measures||Week 144. Serum or Plasma creatinine|||-1.40|-4.57|<0.001
91596258|NCT02831673|183083249|OTHER||Ratio of geometric means|0.915|||<|0.001|TWO_SIDED|95.0|0.887|0.943|||Mixed Model Repeated Measures||Week 24. Serum B2M|||0.943|0.887|<0.001
91596259|NCT02831673|183083249|OTHER||Ratio of geometric means|0.904|||<|0.001|TWO_SIDED|95.0|0.88|0.929|||Mixed Model Repeated Measures||Week 48. Serum B2M|||0.929|0.880|<0.001
91784193|NCT03001817|183448781|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784194|NCT03001817|183448782|SUPERIORITY|||||||0.3669|||||||Hodges-Lehmann method|||||||0.3669
91784195|NCT03001817|183448783|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784196|NCT03001817|183448784|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784197|NCT03001817|183448785|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784198|NCT03001817|183448786|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784199|NCT03001817|183448787|SUPERIORITY|||||||0.0509|||||||Hodges-Lehmann method|||||||0.0509
91784200|NCT03001817|183448788|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784201|NCT03001817|183448789|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784202|NCT03001817|183448790|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784203|NCT03001817|183448791|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784204|NCT03001817|183448792|SUPERIORITY|||||||0.0647|||||||Hodges-Lehmann method|||||||0.0647
91784205|NCT03001817|183448793|SUPERIORITY|||||||0.0007|||||||Hodges-Lehmann method|||||||0.0007
91784206|NCT03001817|183448794|SUPERIORITY|||||||0.1399|||||||Hodges-Lehmann method|||||||0.1399
91784207|NCT03001817|183448795|SUPERIORITY|||||||0.0122|||||||Hodges-Lehmann method|||||||0.0122
91784208|NCT03001817|183448796|SUPERIORITY|||||||0.0994|||||||Hodges-Lehmann method|||||||0.0994
91784209|NCT03001817|183448797|SUPERIORITY|||||||0.0904|||||||Hodges-Lehmann method|||||||0.0904
91784210|NCT03001817|183448798|SUPERIORITY|||||||0.4346|||||||non-parametric Hodges-Lehmann method|||||||0.4346
91784211|NCT03001817|183448799|SUPERIORITY|||||||0.1474|||||||non-parametric Hodges-Lehmann method|||||||0.1474
91784212|NCT03001817|183448800|SUPERIORITY|||||||0.0054|||||||non-parametric Hodges-Lehmann method|||||||0.0054
91784213|NCT03001817|183448801|SUPERIORITY|||||||0.0002|||||||Hodges-Lehmann method|||||||0.0002
91784214|NCT03001817|183448802|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784215|NCT03001817|183448803|SUPERIORITY|||||||0.0118|||||||Hodges-Lehmann method|||||||0.0118
91784216|NCT03001817|183448804|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784217|NCT03001817|183448805|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91784218|NCT03001817|183448806|SUPERIORITY|||||||0.2049|||||||Hodges-Lehmann method|||||||0.2049
91784219|NCT03001817|183448807|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784220|NCT03001817|183448808|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784221|NCT03001817|183448809|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784222|NCT03001817|183448810|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784223|NCT03001817|183448811|SUPERIORITY|||||||0.9117|||||||Hodges-Lehmann method|||||||0.9117
91784224|NCT03001817|183448812|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91784225|NCT01640834|183448888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84||||0.0542|TWO_SIDED|95.0|-11.82|0.14|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||0.14|-11.82|0.0542
91596260|NCT02831673|183083249|OTHER||Ratio of geometric means|0.656||||0.005|TWO_SIDED|95.0|0.491|0.877|||Mixed Model Repeated Measures||Week 24. Urine B2M|||0.877|0.491|0.005
91596261|NCT02831673|183083249|OTHER||Ratio of geometric means|0.672|||<|0.001|TWO_SIDED|95.0|0.551|0.821|||Mixed Model Repeated Measures||Week 48. Urine B2M|||0.821|0.551|<0.001
91596262|NCT02831673|183083249|OTHER||Ratio of geometric means|0.965||||0.575|TWO_SIDED|95.0|0.853|1.092|||Mixed Model Repeated Measures||Week 24. Urine Albumin/Creatinine|||1.092|0.853|0.575
91596263|NCT02831673|183083249|OTHER||Ratio of geometric means|0.891||||0.051|TWO_SIDED|95.0|0.793|1.001|||Mixed Model Repeated Measures||Week 48. Urine Albumin/Creatinine|||1.001|0.793|0.051
91596264|NCT02831673|183083249|OTHER||Ratio of geometric means|0.64|||<|0.001|TWO_SIDED|95.0|0.493|0.831|||Mixed Model Repeated Measures||Week 24. Urine B2M/Urine Creatinine|||0.831|0.493|<0.001
91596265|NCT02831673|183083249|OTHER||Ratio of geometric means|0.695|||<|0.001|TWO_SIDED|95.0|0.576|0.839|||Mixed Model Repeated Measures||Week 48. Urine B2M/Urine Creatinine|||0.839|0.576|<0.001
91596266|NCT02831673|183083249|OTHER||Ratio of geometric means|1.102||||0.099|TWO_SIDED|95.0|0.982|1.237|||Mixed Model Repeated Measures||Week 24. Urine Phosphate|||1.237|0.982|0.099
91596267|NCT02831673|183083249|OTHER||Ratio of geometric means|0.987||||0.816|TWO_SIDED|95.0|0.886|1.1|||Mixed Model Repeated Measures||Week 48. Urine Phosphate|||1.100|0.886|0.816
91596268|NCT02831673|183083249|OTHER||Ratio of geometric means|0.836|||<|0.001|TWO_SIDED|95.0|0.774|0.904|||Mixed Model Repeated Measures||Week 24. Urine Protein/Creatinine|||0.904|0.774|<0.001
91596269|NCT02831673|183083249|OTHER||Ratio of geometric means|0.829|||<|0.001|TWO_SIDED|95.0|0.773|0.888|||Mixed Model Repeated Measures||Week 48. Urine Protein/Creatinine|||0.888|0.773|<0.001
91596270|NCT02831673|183083249|OTHER||Ratio of geometric means|0.871||||0.087|TWO_SIDED|95.0|0.743|1.02|||Mixed Model Repeated Measures||Week 24. Urine RBP 4|||1.020|0.743|0.087
91596271|NCT02831673|183083249|OTHER||Ratio of geometric means|0.748|||<|0.001|TWO_SIDED|95.0|0.644|0.87|||Mixed Model Repeated Measures||Week 48. Urine RBP 4|||0.870|0.644|<0.001
91596272|NCT02831673|183083249|OTHER||Ratio of geometric means|0.828||||0.005|TWO_SIDED|95.0|0.727|0.944|||Mixed Model Repeated Measures||Week 24. Urine RBP 4/Urine Creatinine|||0.944|0.727|0.005
91596273|NCT02831673|183083249|OTHER||Ratio of geometric means|0.765|||<|0.001|TWO_SIDED|95.0|0.677|0.864|||Mixed Model Repeated Measures||Week 48. Urine RBP 4/Urine Creatinine|||0.864|0.677|<0.001
91596274|NCT02831673|183083250|OTHER||Ratio of geometric means|0.839||||0.006|TWO_SIDED|95.0|0.742|0.95|||Mixed Model Repeated Measures||Week 96. Urine Albumin/Creatinine.|||0.950|0.742|0.006
91596275|NCT02831673|183083250|OTHER||Ratio of geometric means|0.551|||<|0.001|TWO_SIDED|95.0|0.445|0.682|||Mixed Model Repeated Measures||Week 96. Urine B2M/Urine Creatinine.|||0.682|0.445|<0.001
91596276|NCT02831673|183083250|OTHER||Ratio of geometric means|1.045||||0.467|TWO_SIDED|95.0|0.928|1.175|||Mixed Model Repeated Measures||Week 96. Urine Phosphate.|||1.175|0.928|0.467
91596277|NCT02831673|183083250|OTHER||Ratio of geometric means|0.824|||<|0.001|TWO_SIDED|95.0|0.764|0.889|||Mixed Model Repeated Measures||Week 96. Urine Protein/Creatinine.|||0.889|0.764|<0.001
91596278|NCT02831673|183083250|OTHER||Ratio of geometric means|0.74|||<|0.001|TWO_SIDED|95.0|0.651|0.84|||Mixed Model Repeated Measures||Week 96. Urine RBP 4/Urine Creatinine|||0.840|0.651|<0.001
91596279|NCT02831673|183083251|OTHER||Ratio of geometric means|0.916||||0.205|TWO_SIDED|95.0|0.799|1.05|||Mixed Model Repeated Measures||Week 144. Urine Albumin/Creatinine.|||1.050|0.799|0.205
91596280|NCT02831673|183083251|OTHER||Ratio of geometric means|0.495|||<|0.001|TWO_SIDED|95.0|0.406|0.603|||Mixed Model Repeated Measures||Week 144. Urine B2M/Urine Creatinine.|||0.603|0.406|<0.001
91596281|NCT02831673|183083251|OTHER||Ratio of geometric means|1.089||||0.16|TWO_SIDED|95.0|0.967|1.226|||Mixed Model Repeated Measures||Week 144. Urine Phosphate.|||1.226|0.967|0.160
91596282|NCT02831673|183083251|OTHER||Ratio of geometric means|0.817|||<|0.001|TWO_SIDED|95.0|0.753|0.885|||Mixed Model Repeated Measures||Week 144. Urine Protein/Creatinine.|||0.885|0.753|<0.001
91596283|NCT02831673|183083251|OTHER||Ratio of geometric means|0.679|||<|0.001|TWO_SIDED|95.0|0.607|0.76|||Mixed Model Repeated Measures||Week 144. Urine RBP 4/Urine Creatinine|||0.760|0.607|<0.001
91596284|NCT02831673|183083252|OTHER||Mean Difference (Net)|-2.23|||<|0.001|TWO_SIDED|95.0|-2.75|-1.7|||Mixed Model Repeated Measures||Week 24. Bone ALP|||-1.70|-2.75|<0.001
91596285|NCT02831673|183083252|OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.19|-1.98|||Mixed Model Repeated Measures||Week 48. Bone ALP|||-1.98|-3.19|<0.001
91596286|NCT02831673|183083252|OTHER||Mean Difference (Net)|-4.19|||<|0.001|TWO_SIDED|95.0|-5.15|-3.23|||Mixed Model Repeated Measures||Week 28. Serum Osteocalcin|||-3.23|-5.15|<0.001
91596287|NCT02831673|183083252|OTHER||Mean Difference (Net)|-5.23|||<|0.001|TWO_SIDED|95.0|-6.22|-4.23|||Mixed Model Repeated Measures||Week 48. Serum Osteocalcin|||-4.23|-6.22|<0.001
91596288|NCT02831673|183083252|OTHER||Mean Difference (Net)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.5|-11.1|||Mixed Model Repeated Measures||Week 24. Serum PINP|||-11.1|-16.5|<0.001
91596289|NCT02831673|183083252|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.0|-10.3|||Mixed Model Repeated Measures||Week 48. Serum PINP|||-10.3|-15.0|<0.001
91596290|NCT02831673|183083252|OTHER||Mean Difference (Net)|-0.1628|||<|0.001|TWO_SIDED|95.0|-0.2015|-0.1241|||Mixed Model Repeated Measures||Week 24. CTX-1|||-0.1241|-0.2015|<0.001
91596291|NCT02831673|183083252|OTHER||Mean Difference (Net)|-0.2015|||<|0.001|TWO_SIDED|95.0|-0.246|-0.1569|||Mixed Model Repeated Measures||Week 48. CTX-1|||-0.1569|-0.2460|<0.001
91596292|NCT02831673|183083253|OTHER||Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.63|-1.5|||Mixed Model Repeated Measures||Week 96, Bone ALP|||-1.50|-2.63|<0.001
91596293|NCT02831673|183083253|OTHER||Mean Difference (Net)|-4.17|||<|0.001|TWO_SIDED|95.0|-5.2|-3.14|||Mixed Model Repeated Measures||Week 96, Serum Osteocalcin|||-3.14|-5.20|<0.001
91596294|NCT02831673|183083253|OTHER||Mean Difference (Net)|-13.3|||<|0.001|TWO_SIDED|95.0|-17.6|-8.9|||Mixed Model Repeated Measures||Week 96, Serum PINP|||-8.9|-17.6|<0.001
91596295|NCT02831673|183083253|OTHER||Mean Difference (Net)|-0.1592|||<|0.001|TWO_SIDED|95.0|-0.208|-0.1104|||Mixed Model Repeated Measures||Week 96, CTX-1|||-0.1104|-0.2080|<0.001
91596296|NCT02831673|183083254|OTHER||Mean Difference (Net)|-1.68|||<|0.001|TWO_SIDED|95.0|-2.23|-1.14|||Mixed Model Repeated Measures||Week 144, Bone ALP|||-1.14|-2.23|<0.001
91596297|NCT02831673|183083254|OTHER||Mean Difference (Net)|-2.91|||<|0.001|TWO_SIDED|95.0|-4.0|-1.83|||Mixed Model Repeated Measures||Week 144, Serum Osteocalcin|||-1.83|-4.00|<0.001
91596298|NCT02831673|183083254|OTHER||Mean Difference (Net)|-9.2|||<|0.001|TWO_SIDED|95.0|-12.3|-6.2|||Mixed Model Repeated Measures||Week 144, Serum PINP|||-6.2|-12.3|<0.001
91596299|NCT02831673|183083254|OTHER||Mean Difference (Net)|-0.1414|||<|0.001|TWO_SIDED|95.0|-0.1771|-0.1056|||Mixed Model Repeated Measures||Week 144, CTX-1|||-0.1056|-0.1771|<0.001
91596300|NCT02831673|183083255|OTHER||Mean Difference (Net)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.9|-3.0|||Mixed Model Repeated Measures||Week 24|||-3.0|-9.9|<0.001
91596301|NCT02831673|183083255|OTHER||Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-9.0|-3.4|||Mixed Model Repeated Measures||Week 48|||-3.4|-9.0|<0.001
91596302|NCT02831673|183083256|OTHER||Mean Difference (Net)|-2.9||||0.048|TWO_SIDED|95.0|-5.8|0.0|||Mixed Model Repeated Measures||Week 96|||0.0|-5.8|0.048
91596303|NCT02831673|183083257|OTHER||Mean Difference (Net)|-4.9||||0.004|TWO_SIDED|95.0|-8.3|-1.6|||Mixed Model Repeated Measures||Week 144|||-1.6|-8.3|0.004
91596304|NCT02831673|183083264|OTHER||Difference in percentage|2.0||||0.157|TWO_SIDED|95.0|-0.6|4.6||Fisher's exact p-value.|Fisher Exact||Week 24|||4.6|-0.6|0.157
91596305|NCT02831673|183083264|OTHER||Difference in percentage|1.3||||0.414|TWO_SIDED|95.0|-1.7|4.2||Fisher's exact p-value.|Fisher Exact||Week 48|||4.2|-1.7|0.414
91596306|NCT02831673|183083265|OTHER||Difference in percentage|1.0||||0.562|TWO_SIDED|95.0|-2.1|4.1||Fisher's exact p-value.|Fisher Exact||Week 96|||4.1|-2.1|0.562
91596307|NCT02831673|183083266|OTHER||Difference in percentage|0.9||||0.587|TWO_SIDED|95.0|-2.4|4.3||Fisher's exact p-value.|Fisher Exact||Week 144|||4.3|-2.4|0.587
91596308|NCT02831673|183083271|OTHER||Mean Difference (Net)|19.8|||||TWO_SIDED|95.0|-10.23|49.83|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||49.83|-10.23|
91596309|NCT02831673|183083271|OTHER||Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|-57.07|58.4|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||58.40|-57.07|
91596310|NCT02831673|183083271|OTHER||Mean Difference (Net)|36.84|||||TWO_SIDED|95.0|-55.94|129.63|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||129.63|-55.94|
91596311|NCT02831673|183083271|OTHER||Mean Difference (Net)|14.37|||||TWO_SIDED|95.0|-13.38|42.12|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||42.12|-13.38|
91596312|NCT02831673|183083271|OTHER||Mean Difference (Net)|25.14|||||TWO_SIDED|95.0|-9.56|59.85|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||59.85|-9.56|
91596313|NCT02831673|183083271|OTHER||Mean Difference (Net)|-7.82|||||TWO_SIDED|95.0|-55.98|40.34|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||40.34|-55.98|
91596314|NCT02831673|183083271|OTHER||Mean Difference (Net)|29.45|||||TWO_SIDED|95.0|-55.47|114.38|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||114.38|-55.47|
91790417|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.188||0.132|TWO_SIDED|95.0|-0.085|0.652||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.652|-0.085|0.132
91596315|NCT02831673|183083271|OTHER||Mean Difference (Net)|17.67|||||TWO_SIDED|95.0|-49.89|85.23|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||85.23|-49.89|
91596316|NCT02831673|183083271|OTHER||Mean Difference (Net)|15.16|||||TWO_SIDED|95.0|-13.9|44.21|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||44.21|-13.90|
91596317|NCT02831673|183083271|OTHER||Mean Difference (Net)|22.51|||||TWO_SIDED|95.0|-9.52|54.54|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||54.54|-9.52|
91596318|NCT02831673|183083271|OTHER||Mean Difference (Net)|-26.67|||||TWO_SIDED|95.0|-110.64|57.3|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||57.30|-110.64|
91596319|NCT02831673|183083271|OTHER||Mean Difference (Net)|4.44||||||95.0|-76.18|85.06|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||85.06|-76.18|
91596320|NCT02831673|183083271|OTHER||Mean Difference (Net)|24.96|||||TWO_SIDED|95.0|-60.68|110.59|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||110.59|-60.68|
91596321|NCT02831673|183083272|OTHER||Mean Difference (Net)|7.6|||||TWO_SIDED|95.0|-24.6|39.8|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||39.8|-24.6|
91596322|NCT02831673|183083272|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-59.8|65.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||65.9|-59.8|
91596323|NCT02831673|183083272|OTHER||Mean Difference (Net)|22.6|||||TWO_SIDED|95.0|-78.3|123.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||123.5|-78.3|
91596324|NCT02831673|183083272|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-24.7|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-24.7|
91596325|NCT02831673|183083272|OTHER||Mean Difference (Net)|8.4|||||TWO_SIDED|95.0|-29.1|45.9|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||45.9|-29.1|
91596326|NCT02831673|183083272|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-53.9|48.9|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||48.9|-53.9|
91596327|NCT02831673|183083272|OTHER||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|-74.6|110.1|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||110.1|-74.6|
91596328|NCT02831673|183083272|OTHER||Mean Difference (Net)|10.4|||||TWO_SIDED|95.0|-62.3|83.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||83.1|-62.3|
91596329|NCT02831673|183083272|OTHER||Mean Difference (Net)|5.6|||||TWO_SIDED|95.0|-25.6|36.9|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||36.9|-25.6|
91596330|NCT02831673|183083272|OTHER||Mean Difference (Net)|6.3|||||TWO_SIDED|95.0|-28.2|40.9|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||40.9|-28.2|
91596331|NCT02831673|183083272|OTHER||Mean Difference (Net)|-30.2|||||TWO_SIDED|95.0|-122.7|62.4|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||62.4|-122.7|
91596332|NCT02831673|183083272|OTHER||Mean Difference (Net)|49.2|||||TWO_SIDED|95.0|-36.3|134.7|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||134.7|-36.3|
91596333|NCT02831673|183083272|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-94.7|89.7|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||89.7|-94.7|
91596334|NCT02831673|183083273|OTHER||Mean Difference (Net)|1.9|||||TWO_SIDED|95.0|-34.5|38.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.2|-34.5|
91596335|NCT02831673|183083273|OTHER||Mean Difference (Net)|40.1|||||TWO_SIDED|95.0|-31.2|111.5|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||111.5|-31.2|
91596336|NCT02831673|183083273|OTHER||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-122.3|114.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||114.5|-122.3|
91596337|NCT02831673|183083273|OTHER||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|-22.9|44.5|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||44.5|-22.9|
91709316|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.652|TWO_SIDED|95.0|-0.37|0.23|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.23|-0.37|0.652
91649135|NCT01827371|183190792|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|-0.1|||||TWO_SIDED|98.33|-0.5|0.3||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.30|-0.50|
91649136|NCT00950599|183190794|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||A significance level of alpha = 0.05 was used for the trend test.|Kruskal-Wallis|ANCOVA Model: post-pre=pre treatment.||A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.||||0.9888
91649137|NCT00950599|183190795|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.|ANCOVA|ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.||||||0.9888
91649138|NCT01361607|183190878|SUPERIORITY||Median Difference (Final Values)|-1.84||||0.2735|TWO_SIDED|95.0|-6.19|1.5|||Wilcoxon (Mann-Whitney)|||||1.50|-6.19|0.2735
91649139|NCT00125931|183190889|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|95.0|||||ANOVA|||comparison of mean scores at hour 2 vs 3||||0.01
91649140|NCT00125931|183190890|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||comparison of mean score on treatment vs post-treatment days||||0.01
91649141|NCT00125931|183190890|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 1 sided|||comparison of mean scores at pre-treatment vs treatment days||||0.4
91596338|NCT02831673|183083273|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-35.0|49.6|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.6|-35.0|
91596339|NCT02831673|183083273|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-60.7|55.7|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||55.7|-60.7|
91596340|NCT02831673|183083273|OTHER||Mean Difference (Net)|41.6|||||TWO_SIDED|95.0|-61.2|144.5|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||144.5|-61.2|
91596341|NCT02831673|183083273|OTHER||Mean Difference (Net)|18.8|||||TWO_SIDED|95.0|-64.2|101.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||101.8|-64.2|
91596342|NCT02831673|183083273|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|95.0|-27.4|43.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||43.1|-27.4|
91596343|NCT02831673|183083273|OTHER||Mean Difference (Net)|15.2|||||TWO_SIDED|95.0|-23.6|54.0|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||54.0|-23.6|
91596344|NCT02831673|183083273|OTHER||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-106.3|103.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||103.0|-106.3|
91596345|NCT02831673|183083273|OTHER||Median Difference (Net)|-32.6|||||TWO_SIDED|95.0|-132.2|66.9|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||66.9|-132.2|
91596346|NCT02831673|183083273|OTHER||Mean Difference (Net)|26.1|||||TWO_SIDED|95.0|-77.3|129.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.5|-77.3|
91649142|NCT02273206|183190893|SUPERIORITY|||||||0.2562|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference||||0.2562
91649143|NCT02273206|183190893|SUPERIORITY|||||||0.9795|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference||||0.9795
91596347|NCT02831673|183083274|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-39.2|38.3|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.3|-39.2|
91596348|NCT02831673|183083274|OTHER||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|-69.4|78.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||78.8|-69.4|
91596349|NCT02831673|183083274|OTHER||Mean Difference (Net)|17.4|||||TWO_SIDED|95.0|-111.1|145.8|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||145.8|-111.1|
91649144|NCT02273206|183190893|SUPERIORITY|||||||0.3917|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference||||0.3917
91649145|NCT02273206|183190894|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.346||||0.0677|TWO_SIDED|95.0|0.979|1.851||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline colorectal cancer up to date status, age, and income.|||1.851|0.979|0.0677
91649146|NCT02273206|183190895|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.031||||0.8501|TWO_SIDED|95.0|0.753|1.41||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline breast cancer up to date status, age, and income|||1.410|0.753|0.8501
91649147|NCT02273206|183190896|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|0.876||||0.4432|TWO_SIDED|95.0|0.625|1.228||Treatment Group(CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline cervical cancer up to date status, age, and income.|||1.228|0.625|0.4432
91649148|NCT02273206|183190897|SUPERIORITY|||||||0.39|||||||Two-sample t-test|p\<0.05||PHQ9 Intervention Arm Difference between baseline and 12-month follow up||||0.39
91596350|NCT02831673|183083274|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-37.2|34.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||34.1|-37.2|
91596351|NCT02831673|183083274|OTHER||Mean Difference (Net)|-18.0|||||TWO_SIDED|95.0|-63.2|27.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||27.1|-63.2|
91596352|NCT02831673|183083274|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-57.0|64.0|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||64.0|-57.0|
91596353|NCT02831673|183083274|OTHER||Mean Difference (Net)|95.2|||||TWO_SIDED|95.0|-14.8|205.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||205.2|-14.8|
91596354|NCT02831673|183083274|OTHER||Mean Difference (Net)|24.9|||||TWO_SIDED|95.0|-62.5|112.3|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||112.3|-62.5|
91596355|NCT02831673|183083274|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-41.5|33.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||33.1|-41.5|
91596356|NCT02831673|183083274|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-40.6|41.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||41.1|-40.6|
91596357|NCT02831673|183083274|OTHER||Mean Difference (Net)|-51.3|||||TWO_SIDED|95.0|-163.6|60.9|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||60.9|-163.6|
91596358|NCT02831673|183083274|OTHER||Median Difference (Net)|-20.1|||||TWO_SIDED|95.0|-125.3|85.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction|||85.0|-125.3|
91596359|NCT02831673|183083274|OTHER||Mean Difference (Net)|66.2|||||TWO_SIDED|95.0|-43.7|176.2|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||176.2|-43.7|
91596360|NCT02831673|183083275|OTHER||Mean Difference (Net)|0.0052||||0.302|TWO_SIDED|95.0|-0.0047|0.0152|||MMRM||Week 4. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0152|-0.0047|0.302
91596361|NCT02831673|183083275|OTHER||Mean Difference (Net)|-0.0038||||0.45|TWO_SIDED|95.0|-0.0136|0.006|||MMRM||Week24. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0060|-0.0136|0.450
91596362|NCT02831673|183083275|OTHER||Mean Difference (Net)|0.0004||||0.934|TWO_SIDED|95.0|-0.0098|0.0106|||MMRM||Week48. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0106|-0.0098|0.934
91596363|NCT02831673|183083276|OTHER||Mean Difference (Net)|-0.0012||||0.842|TWO_SIDED|95.0|-0.0132|0.0107|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0107|-0.0132|0.842
91596364|NCT02831673|183083277|OTHER||Mean Difference (Net)|0.0008||||0.879|TWO_SIDED|95.0|-0.0097|0.0113|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0113|-0.0097|0.879
91596365|NCT02831673|183083278|OTHER||Mean Difference (Net)|1.1||||0.137|TWO_SIDED|95.0|-0.3|2.4|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.4|-0.3|0.137
91649149|NCT02273206|183190898|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at baseline.||||0.60
91649150|NCT02273206|183190898|SUPERIORITY|||||||0.86|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 6 Months||||0.86
91649151|NCT02273206|183190899|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at Baseline.||||0.60
91649152|NCT02273206|183190899|SUPERIORITY|||||||0.23|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 12 months.||||0.23
91596366|NCT02831673|183083278|OTHER||Mean Difference (Net)|0.6||||0.458|TWO_SIDED|95.0|-0.9|2.0|||MMRM||Week24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.0|-0.9|0.458
91596367|NCT02831673|183083278|OTHER||Mean Difference (Net)|1.5||||0.031|TWO_SIDED|95.0|0.1|2.8|||MMRM||Week48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.8|0.1|0.031
91596368|NCT02831673|183083279|OTHER||Mean Difference (Net)|1.7||||0.027|TWO_SIDED|95.0|0.2|3.2|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.2|0.2|0.027
91596369|NCT02831673|183083280|OTHER||Mean Difference (Net)|2.3||||0.001|TWO_SIDED|95.0|0.9|3.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.6|0.9|0.001
91596370|NCT00150592|183083281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANCOVA|||||||0.844
91596371|NCT00150592|183083282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274||95.0|||||ANCOVA|Mean reaction time (adjusted) for each randomized treatment group at endpoint.||||||0.274
91596372|NCT00150592|183083284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||95.0|||||ANCOVA|||Between errors||||0.307
91649153|NCT02273206|183190900|SUPERIORITY|||||||0.4483|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference at 12 Months||||0.4483
91596373|NCT00150592|183083284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0|||||ANCOVA|||Within errors||||0.552
91596374|NCT00150592|183083284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917||95.0|||||ANCOVA|||Double errors||||0.917
91596375|NCT00150592|183083284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||95.0|||||ANCOVA|||Strategy||||0.068
91596376|NCT00150592|183083285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
91649154|NCT02273206|183190900|SUPERIORITY|||||||0.1706|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference at 12 Months||||0.1706
91649155|NCT02273206|183190900|SUPERIORITY|||||||0.3568|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference at 12 Months||||0.3568
91649156|NCT02273206|183190901|SUPERIORITY|||||||0.85|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at baseline.||||0.85
91649157|NCT02273206|183190901|SUPERIORITY|||||||0.23|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 6 months.||||0.23
91522184|NCT00514683|182919358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.0847|TWO_SIDED|95.0|0.106|1.154|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.154|0.106|0.0847
91596377|NCT00150592|183083286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
91596378|NCT00150592|183083287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||ANCOVA|||||||0.02
91596379|NCT00150592|183083288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANCOVA|||||||0.231
91596380|NCT01157078|183083294|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|1.08||0.349|TWO_SIDED|95.0|-3.14|1.11||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-3.14|0.349
91596381|NCT01157078|183083295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.29||0.444|TWO_SIDED|95.0|0.75|1.92|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.92|0.75|0.444
91596382|NCT01157078|183083296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|STANDARD_ERROR_OF_MEAN|0.42||0.13|TWO_SIDED|95.0|0.88|2.61|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.61|0.88|0.130
91613588|NCT01899144|183121466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0488|TWO_SIDED|95.0|-0.38|0.0||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.00|-0.38|0.0488
91613589|NCT02222129|183121474|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.||||0.39
91649158|NCT02273206|183190901|SUPERIORITY|||||||0.98|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 12 months.||||0.98
91649159|NCT02273206|183190901|SUPERIORITY|||||||0.57|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at baseline.||||0.57
91649160|NCT02273206|183190901|SUPERIORITY|||||||0.92|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 6 months.||||0.92
91649161|NCT02273206|183190901|SUPERIORITY|||||||0.99|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 12 months.||||0.99
91649162|NCT02273206|183190902|SUPERIORITY|||||||0.2|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at baseline.||||0.20
91649163|NCT02273206|183190902|SUPERIORITY|||||||0.17|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 6 months.||||0.17
91649164|NCT02273206|183190902|SUPERIORITY|||||||0.69|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 12 months.||||0.69
91649165|NCT02273206|183190902|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at baseline.||||0.72
91649166|NCT02273206|183190902|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 6 months.||||0.72
91649167|NCT02273206|183190902|SUPERIORITY|||||||0.87|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 12 months.||||0.87
91649168|NCT02273206|183190902|SUPERIORITY|||||||0.65|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at baseline.||||0.65
91649169|NCT02273206|183190902|SUPERIORITY|||||||0.82|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 6 months.||||0.82
91784226|NCT01640834|183448888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.89||||0.0826|TWO_SIDED|95.0|-14.95|1.16|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.||1.16|-14.95|0.0826
91649170|NCT02273206|183190902|SUPERIORITY|||||||0.92|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 12 months.||||0.92
91649171|NCT02273206|183190902|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months.||||0.56
91649172|NCT02273206|183190903|SUPERIORITY|||||||0.17|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at baseline.||||0.17
91790418|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91649173|NCT02273206|183190903|SUPERIORITY|||||||0.38|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 6 months.||||0.38
91649174|NCT02273206|183190903|SUPERIORITY|||||||0.07|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 12 months.||||0.07
91649175|NCT02273206|183190903|SUPERIORITY|||||||0.99|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at baseline.||||0.99
91649176|NCT02273206|183190903|SUPERIORITY|||||||0.15|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 6 months.||||0.15
91649177|NCT02273206|183190903|SUPERIORITY|||||||0.55|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 12 months.||||0.55
91649178|NCT02273206|183190903|SUPERIORITY|||||||0.34|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at baseline.||||0.34
91649179|NCT02273206|183190903|SUPERIORITY|||||||0.31|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 6 months. .||||0.31
91649180|NCT02273206|183190903|SUPERIORITY|||||||0.39|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 12 months.||||0.39
91649181|NCT02273206|183190903|SUPERIORITY|||||||0.87|||||||Chi-squared|||Physician Recommendation of Mental Health Care at baseline.||||0.87
91649182|NCT02273206|183190903|SUPERIORITY|||||||0.83|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 6 months.||||0.83
91649183|NCT02273206|183190903|SUPERIORITY|||||||0.36|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 12 months.||||0.36
91649184|NCT02273206|183190904|SUPERIORITY|||||||0.95|||||||Chi-squared|||Generalized Anxiety Disorder scale at baseline. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.95
91649185|NCT02273206|183190904|SUPERIORITY|||||||0.08|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 6 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.08
91649186|NCT02273206|183190904|SUPERIORITY|||||||0.27|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 12 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.27
91649187|NCT02273206|183190905|SUPERIORITY|||||||0.54|||||||Chi-squared|||Medical Outcomes Study Health Survey at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.54
91649188|NCT02273206|183190905|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
91649189|NCT02273206|183190905|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
91649190|NCT02273206|183190906|SUPERIORITY|||||||0.74|||||||Chi-squared|||Colorectal Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.74
91649191|NCT02273206|183190906|SUPERIORITY|||||||0.86|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.86
91649192|NCT02273206|183190906|SUPERIORITY|||||||0.79|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.79
91649193|NCT02273206|183190906|SUPERIORITY|||||||0.91|||||||Chi-squared|||Breast Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
91596383|NCT01157078|183083297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|STANDARD_ERROR_OF_MEAN|0.96||0.307|TWO_SIDED|95.0|0.6|5.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||5.14|0.60|0.307
91596384|NCT01157078|183083298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.52||0.313|TWO_SIDED|95.0|0.71|2.94|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.94|0.71|0.313
91596385|NCT01157078|183083299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|STANDARD_ERROR_OF_MEAN|0.79||0.201|TWO_SIDED|95.0|0.74|4.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||4.24|0.74|0.201
91596386|NCT01157078|183083300|SUPERIORITY_OR_OTHER||LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.552|TWO_SIDED|95.0|-2.1|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-2.10|0.552
91596387|NCT01157078|183083301|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.803||95.0|-0.31|0.24|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.24|-0.31|0.803
91596388|NCT01157078|183083302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.28||0.44|TWO_SIDED|95.0|0.75|1.91|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.91|0.75|0.440
91596389|NCT01157078|183083303|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.768|TWO_SIDED|95.0|-0.91|1.23||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.23|-0.91|0.768
91596390|NCT01157078|183083304|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.373|TWO_SIDED|95.0|-0.84|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.84|0.373
91596391|NCT01157078|183083305|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.435|TWO_SIDED|95.0|-2.47|1.07|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.07|-2.47|0.435
91784227|NCT01640834|183448889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.046|TWO_SIDED|95.0|-33.7|-0.4|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||-0.4|-33.7|0.0460
91596392|NCT01157078|183083306|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.97||0.501|TWO_SIDED|95.0|-2.56|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.25|-2.56|0.501
91596393|NCT01157078|183083307|SUPERIORITY_OR_OTHER||LS mean|-0.62|STANDARD_ERROR_OF_MEAN|0.771||0.424|TWO_SIDED|95.0|-2.134|0.901||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.901|-2.134|0.424
91596394|NCT01157078|183083308|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.214|TWO_SIDED|95.0|-0.96|0.22||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.22|-0.96|0.214
91596395|NCT01157078|183083309|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.931|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.59|0.931
91784228|NCT01640834|183448889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6||||0.0192|TWO_SIDED|95.0|-35.0|-4.3|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.||-4.3|-35.0|0.0192
91784229|NCT01640834|183448894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.0||||0.0187|TWO_SIDED|95.0|-82.0|-9.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-9|-82|0.0187
91649194|NCT02273206|183190906|SUPERIORITY|||||||0.71|||||||Chi-squared|||Breast Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.71
91649195|NCT02273206|183190906|SUPERIORITY|||||||0.77|||||||Chi-squared|||Breast Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.77
91649196|NCT02273206|183190906|SUPERIORITY|||||||0.64|||||||Chi-squared|||Cervical Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.64
91649197|NCT02273206|183190906|SUPERIORITY|||||||0.11|||||||Chi-squared|||Cervical Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.11
91649198|NCT02273206|183190906|SUPERIORITY|||||||1|||||||Chi-squared|||Cervical Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||1.00
91649199|NCT02273206|183190908|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months. Recoding of the continuous measure was based on quartiles.||||0.56
91649200|NCT02273206|183190909|SUPERIORITY|||||||0.18|||||||Chi-squared|||Devaluation-Discrimination Scale Score at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.18
91649201|NCT02273206|183190909|SUPERIORITY|||||||0.32|||||||Chi-squared|||Devaluation-Discrimination Scale score at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.32
91649202|NCT02273206|183190910|SUPERIORITY|||||||0.5|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.50
91649203|NCT02273206|183190910|SUPERIORITY|||||||0.51|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.51
91649204|NCT02273206|183190910|SUPERIORITY|||||||0.02|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.02
91649205|NCT02273206|183190910|SUPERIORITY|||||||0.91|||||||Chi-squared|||Ambulatory Care Experiences - Access at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
91522185|NCT00514683|182919358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5383|TWO_SIDED|95.0|0.271|1.977|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.977|0.271|0.5383
91784230|NCT01640834|183448894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.0||||0.0048|TWO_SIDED|95.0|-96.0|-23.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-23|-96|0.0048
91596396|NCT01157078|183083310|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.755|TWO_SIDED|95.0|-0.6|0.44|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.44|-0.60|0.755
91596397|NCT01157078|183083311|SUPERIORITY_OR_OTHER||LS mean|0.82|STANDARD_ERROR_OF_MEAN|1.789||0.646|TWO_SIDED|95.0|-2.699|4.346|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.346|-2.699|0.646
91596398|NCT01157078|183083312|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.446|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.14|-0.31|0.446
91596399|NCT01157078|183083313|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.178|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.33|-0.06|0.178
91596400|NCT01157078|183083314|SUPERIORITY_OR_OTHER||LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.61||0.515|TWO_SIDED|95.0|-4.22|2.12|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.12|-4.22|0.515
91649206|NCT02273206|183190910|SUPERIORITY|||||||0.69|||||||Chi-squared|||Ambulatory Care Experiences - Access at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.69
91649207|NCT02273206|183190910|SUPERIORITY|||||||0.63|||||||Chi-squared|||Ambulatory Care Experiences - Access at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.63
91649208|NCT02273206|183190910|SUPERIORITY|||||||0.55|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.55
91649209|NCT02273206|183190910|SUPERIORITY|||||||0.34|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.34
91649210|NCT02273206|183190910|SUPERIORITY|||||||0.19|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.19
91649211|NCT02273206|183190910|SUPERIORITY|||||||0.47|||||||Chi-squared|||Ambulatory Care Experiences - Quality at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.47
91649212|NCT02273206|183190910|SUPERIORITY|||||||0.38|||||||Chi-squared|||Ambulatory Care Experiences - Quality at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.38
91649213|NCT02273206|183190910|SUPERIORITY|||||||0.98|||||||Chi-squared|||Ambulatory Care Experiences - Quality at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.98
91649214|NCT02273206|183190911|SUPERIORITY|||||||0.78|||||||Chi-squared|||Medication Adherence at baseline. Coding of the measure was based on Morisky et al. (2008).||||0.78
91649215|NCT02273206|183190911|SUPERIORITY|||||||0.2|||||||Chi-squared|||Medication Adherence at 6 months. Coding of the measure was based on Morisky et al. (2008).||||0.20
91784231|NCT01640834|183448895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4423.0||||0.0278|TWO_SIDED|95.0|-8256.0|-590.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-590|-8256|0.0278
91596401|NCT01157078|183083315|SUPERIORITY_OR_OTHER||LS mean|0.024|STANDARD_ERROR_OF_MEAN|0.0226||0.298|TWO_SIDED|95.0|-0.0209|0.068||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0680|-0.0209|0.298
91596402|NCT01157078|183083315|SUPERIORITY_OR_OTHER||LS mean|1.6|STANDARD_ERROR_OF_MEAN|2.34||0.484|TWO_SIDED|95.0|-2.98|6.26||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.26|-2.98|0.484
91784232|NCT01640834|183448895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5187.0||||0.0046|TWO_SIDED|95.0|-8371.0|-2004.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-2004|-8371|0.0046
91784233|NCT01387542|183448896|SUPERIORITY_OR_OTHER|||||||0|||||||Friedman test|||||||0.000
91596403|NCT01560780|183083366|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
91596404|NCT01560780|183083367|EQUIVALENCE|safety end-point with p-value of \<0.05|||||>|0.99|||||||Log Rank|||||||>0.99
91649216|NCT02273206|183190911|SUPERIORITY|||||||0.77|||||||Chi-squared|||Medication Adherence at 12 Months. Coding of the measure was based on Morisky et al. (2008).||||0.77
91784234|NCT01387542|183448897|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||||||0.009
91784235|NCT01387542|183448898|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||||||0.001
91784236|NCT01387542|183448899|SUPERIORITY_OR_OTHER|||||||0|||||||Paired t-test|||||||0.000
91784237|NCT03601117|183448900|OTHER|This is to test for the antidepressant effect of LDLPFC stimulation. Test is change in score from baseline to approximately 48 hours after the final session.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
91784238|NCT00130247|183449119|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.051||||||95.0|0.01|0.09|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|Comparison of binomial proportion of relapse: Intention-to-treat||0.09|0.01|
91596405|NCT01560780|183083368|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
91596406|NCT01560780|183083369|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
91596407|NCT01560780|183083370|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91596408|NCT01560780|183083372|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91596409|NCT01500278|183083373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||=|0.467|TWO_SIDED|95.0|0.67|1.2||The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and age as a covariate.|Regression, Logistic|||||1.20|0.67|=0.467
91649217|NCT02273206|183190912|SUPERIORITY|||||||0.7|||||||Chi-squared|||Self-efficacy at baseline.Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.70
91596410|NCT01500278|183083374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||=|0.532|TWO_SIDED|95.0|0.82|1.45||The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.|Regression, Logistic|||||1.45|0.82|=0.532
91596411|NCT00595556|183083408|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Mixed Models Analysis|||||||.012
91596412|NCT00595556|183083409|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Mixed Models Analysis|||||||.94
91596413|NCT00595556|183083410|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||.004
91596414|NCT00595556|183083411|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|||||||.006
91596415|NCT00595556|183083412|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|||||||.3
91649218|NCT02273206|183190912|SUPERIORITY|||||||0.89|||||||Chi-squared|||Self-efficacy at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.89
91784239|NCT00130247|183449122|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.43||||||95.0|0.94|12.5|||Regression, Linear|||Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.||12.5|0.94|
91784240|NCT00130247|183449122|SUPERIORITY_OR_OTHER||Incident rate ratio|4.52||||||95.0|1.29|15.9|||Regression, Linear|||Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.||15.9|1.29|
91784241|NCT00130247|183449128|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.054||||||95.0|0.01|0.1|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|||0.10|0.01|
91649219|NCT02273206|183190912|SUPERIORITY|||||||0.95|||||||Chi-squared|||Self-efficacy at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.95
91649220|NCT02741271|183190922|SUPERIORITY||LSM Difference|5.21|||<|0.001|TWO_SIDED|95.0|3.21|7.2|||cLDA with multiple imputation|Primary Analysis Method, using the constrained Longitudinal Data Analysis (cLDA) model for missing data|Between-Treatment Difference|||7.20|3.21|<0.001
91649221|NCT02741271|183190925|SUPERIORITY||LSM Difference|6.05|||<|0.001|TWO_SIDED|95.0|3.53|8.56|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 4 hr Post-Dose|||8.56|3.53|<0.001
91649222|NCT02741271|183190925|SUPERIORITY||LSM Difference|7.04|||<|0.001|TWO_SIDED|95.0|4.74|9.35|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 2 hr Post-Dose|||9.35|4.74|<0.001
91649223|NCT02741271|183190925|SUPERIORITY||LSM Difference|6.19|||<|0.001|TWO_SIDED|95.0|4.09|8.28|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 60 min Post-Dose|||8.28|4.09|<0.001
91649224|NCT02741271|183190925|SUPERIORITY||LSM Difference|6.89|||<|0.001|TWO_SIDED|95.0|5.1|8.67|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 30 min Post-Dose|||8.67|5.10|<0.001
91649225|NCT02741271|183190925|SUPERIORITY||LSM Difference|6.64|||<|0.001|TWO_SIDED|95.0|4.89|8.39|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 15 min Post-Dose|||8.39|4.89|<0.001
91649226|NCT02741271|183190925|SUPERIORITY||LSM Difference|4.2|||<|0.001|TWO_SIDED|95.0|2.5|5.91|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 5 min Post-Dose|||5.91|2.50|<0.001
91649227|NCT02741271|183190926|SUPERIORITY||LSM Difference|6.32|||<|0.001|TWO_SIDED|95.0|4.36|8.27|||cLDA|Secondary Outcome Measure on Day 1|Between-Treatment Difference at 4 hr Post-Dose|||8.27|4.36|<0.001
91649228|NCT02741271|183190926|SUPERIORITY||LSM Difference|3.33||||0.026|TWO_SIDED|95.0|0.41|6.26|||cLDA|Secondary Outcome Measure at Week 12|Between-Treatment Difference at 4 hr Post-Dose|||6.26|0.41|0.026
91649229|NCT02741271|183190927|SUPERIORITY||LSM Difference|1.63||||0.197|TWO_SIDED|95.0|-0.85|4.11|||cLDA|Secondary Outcome Measure|Between-Treatment Difference|||4.11|-0.85|0.197
91649230|NCT00373685|183190935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED|||||Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test|Life Table Extension of CMH Test|||||||0.0003
91649231|NCT00373685|183190936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.0035
91649232|NCT00373685|183190937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.6140
91649233|NCT00373685|183190939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
91649234|NCT00373685|183190941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
91649235|NCT00373685|183190942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023|TWO_SIDED|||||P-value associated with Overall (LOCF)|Cochran-Mantel-Haenszel|||||||0.0023
91649236|NCT00373685|183190943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008|TWO_SIDED||||||Chi-squared|||Baseline||||0.1008
91649237|NCT00373685|183190943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
91784242|NCT03844945|183449130|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91649238|NCT00373685|183190943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
91649239|NCT00373685|183190943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0005
91649240|NCT00373685|183190943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||<0.0001
91649241|NCT00373685|183190944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6562|TWO_SIDED||||||Chi-squared|||Baseline||||0.6562
91784243|NCT04518995|183449131|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.23|<0.0001
91784244|NCT04518995|183449131|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.46|0.32|<0.0001
91649242|NCT00373685|183190944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
91649243|NCT00373685|183190944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
91649244|NCT00373685|183190944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0245|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0245
91649245|NCT00373685|183190944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0074
91649246|NCT00373685|183190945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4074|TWO_SIDED||||||Chi-squared|||Baseline||||0.4074
91649247|NCT00373685|183190945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
91649248|NCT00373685|183190945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
91649249|NCT00373685|183190945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0127
91649250|NCT00373685|183190945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0019
91649251|NCT00373685|183190946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2699|TWO_SIDED||||||Chi-squared|||Baseline||||0.2699
91649252|NCT00373685|183190946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
91649253|NCT00373685|183190946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
91649254|NCT00373685|183190946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0027
91649255|NCT00373685|183190946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0001
91709317|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.02||||0.905|TWO_SIDED|95.0|-0.28|0.32|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.32|-0.28|0.905
91784245|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.17|0.32||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.32|0.17|<0.0001
91596416|NCT00689572|183083432|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|-0.09||||0.972|TWO_SIDED|95.0|-5.43|5.25|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)||5.25|-5.43|0.972
91596417|NCT00689572|183083433|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|0.44||||0.909|TWO_SIDED|95.0|-7.08|7.95|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)||7.95|-7.08|0.909
91596418|NCT04770389|183083438|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
91596419|NCT04770389|183083439|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
91596420|NCT04770389|183083440|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
91596421|NCT04770389|183083441|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
91596422|NCT04770389|183083442|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
91596423|NCT04770389|183083443|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
91649256|NCT02570165|183190950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|191.1|||||TWO_SIDED|95.0|101.07|284.26|||||The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.|||284.26|101.07|
91784246|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.26|0.43||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.26|<0.0001
91784247|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.24|0.38||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.38|0.24|<0.0001
91596424|NCT04770389|183083444|SUPERIORITY||Least Squares (LS) Means|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
91596425|NCT04770389|183083445|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
91784248|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|<0.0001
91596426|NCT04770389|183083446|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
91596427|NCT04770389|183083447|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
91596428|NCT04770389|183083448|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
91596429|NCT04770389|183083449|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
91596430|NCT04770389|183083450|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
91596431|NCT04770389|183083451|SUPERIORITY||Least Squares (LS) Mean|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
91596432|NCT04770389|183083452|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
91596433|NCT04770389|183083453|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
91596434|NCT04770389|183083454|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
91596435|NCT04770389|183083455|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
91596436|NCT04770389|183083456|SUPERIORITY||Least Squares (LS) Means|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
91596437|NCT04770389|183083457|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
91596438|NCT04770389|183083458|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
91649257|NCT02570165|183190950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|231.6|||||TWO_SIDED|95.0|149.31|310.02|||||The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.|||310.02|149.31|
91596439|NCT04770389|183083459|SUPERIORITY||Least Squares (LS) Means|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
91596440|NCT04770389|183083460|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
91596441|NCT04770389|183083461|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
91596442|NCT04770389|183083462|SUPERIORITY||Least Squares (LS) Means|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
91596443|NCT04770389|183083463|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
91649258|NCT02570165|183190950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|261.8|||||TWO_SIDED|95.0|189.85|332.25|||||The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.|||332.25|189.85|
91784249|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.26|0.39||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.39|0.26|<0.0001
91596444|NCT04770389|183083464|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
91596445|NCT04770389|183083465|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
91596446|NCT04770389|183083466|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
91596447|NCT04770389|183083467|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
91596448|NCT04770389|183083468|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
91596449|NCT04770389|183083469|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
91596450|NCT04770389|183083470|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
91596451|NCT03817775|183083481|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91596452|NCT03817775|183083482|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91596453|NCT03817775|183083483|OTHER|||||||0.7215|||||||Wilcoxon (Mann-Whitney)|||||||0.7215
91596454|NCT03817775|183083484|OTHER|||||||0.5675|||||||Wilcoxon (Mann-Whitney)|||||||0.5675
91596455|NCT03817775|183083485|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91596456|NCT00531752|183083502|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.7947|STANDARD_ERROR_OF_MEAN|1.8848||0.6749|TWO_SIDED|80.0|-1.649|3.2383||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2383|-1.649|0.6749
91596457|NCT00531752|183083502|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4176|STANDARD_ERROR_OF_MEAN|2.0343||0.4886|TWO_SIDED|80.0|-1.218|4.0533||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0533|-1.218|0.4886
91649259|NCT02570165|183190950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|281.4|||||TWO_SIDED|95.0|212.35|351.3|||||The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.|||351.30|212.35|
91784250|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.55|0.39|<0.0001
91784251|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.31|0.44||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.31|<0.0001
91784252|NCT04518995|183449132|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.55|0.39|<0.0001
91784253|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0816|TWO_SIDED|95.0|0.0|0.02||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.02|-0.00|0.0816
91649260|NCT02570165|183190950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|292.8|||||TWO_SIDED|95.0|223.02|364.42|||||The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.|||364.42|223.02|
91649261|NCT02570165|183190951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.2|||||TWO_SIDED|95.0|99.8|264.6|||||The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.|||264.60|99.80|
91649262|NCT02570165|183190951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.6|||||TWO_SIDED|95.0|128.4|264.8|||||The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.|||264.80|128.40|
91649263|NCT02570165|183190951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.6|||||TWO_SIDED|95.0|137.2|272.1|||||The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.|||272.10|137.20|
91649264|NCT02570165|183190951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|208.9|||||TWO_SIDED|95.0|138.7|279.2|||||The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.|||279.20|138.70|
91649265|NCT02570165|183190951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.1|||||TWO_SIDED|95.0|138.6|283.7|||||The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.|||283.70|138.60|
91649266|NCT04428502|183190988|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.6|||||||Student's t-test|||At Month 1: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.6
91649267|NCT04428502|183190988|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.007|||||||Student's t-test|||At Month 6: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.007
91649268|NCT04428502|183190988|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.004|||||||Student's t-test|||At Month 12: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.004
91649269|NCT02295280|183190995|SUPERIORITY|||||||0.14||||||Reduction in pain scores by at least 2 units six hours post administration|Mann Whitney U test|Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.||A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.||||0.14
91784254|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.0005|TWO_SIDED|95.0|0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|0.01|0.0005
91784255|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.016||0.0002|TWO_SIDED|95.0|0.03|0.09||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.09|0.03|0.0002
91784256|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
91649270|NCT01241565|183191015|SUPERIORITY_OR_OTHER||Rate of incidence of PAL|10.6|||||TWO_SIDED|95.0|3.9|21.3|||||Incidence of Prolonged Air Leak (PAL) is estimated at between 5-10% in literature. PAL of 10%of evaluable cases was used to determine study success.|||21.3|3.9|
91649271|NCT02713243|183191022|SUPERIORITY||Mean Difference (Net)|4.04||||0.01|TWO_SIDED|95.0|0.98|7.11|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||7.11|0.98|0.01
91649272|NCT02713243|183191022|SUPERIORITY||Mean Difference (Net)|1.31||||0.401|TWO_SIDED|95.0|-1.77|4.38|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||4.38|-1.77|0.401
91649273|NCT02713243|183191022|SUPERIORITY||Mean Difference (Net)|2.67||||0.019|TWO_SIDED|95.0|0.46|4.89|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||4.89|0.46|0.019
91784257|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.22|0.12|<0.0001
91649274|NCT02713243|183191027|SUPERIORITY||Mean Difference (Net)|0.12||||0.533|TWO_SIDED|95.0|-0.27|0.52|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||0.52|-0.27|0.533
91649275|NCT02713243|183191027|SUPERIORITY||Mean Difference (Net)|-0.09||||0.64|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||0.30|-0.49|0.640
91649276|NCT02713243|183191027|SUPERIORITY||Mean Difference (Net)|0.02||||0.916|TWO_SIDED|95.0|-0.27|0.3|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||0.30|-0.27|0.916
91649277|NCT01133392|183191028|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.99|||||TWO_SIDED|90.0|0.948|1.034||||||||1.034|0.948|
91649278|NCT01133392|183191029|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.933|||||TWO_SIDED|90.0|0.897|0.972||||||||0.972|0.897|
91649279|NCT01133392|183191030|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.005|||||TWO_SIDED|90.0|0.958|1.054||||||||1.054|0.958|
91649280|NCT01133392|183191031|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.4|0.5||||||||0.500|-0.400|
91649281|NCT01133392|183191032|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.014|||||TWO_SIDED|90.0|0.961|1.07||||||||1.070|0.961|
91522186|NCT00514683|182919359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.483||0.3658|TWO_SIDED|95.0|-0.51|1.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.39|-0.51|0.3658
91649282|NCT03751124|183191033|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|63.36|||<|0.0001|TWO_SIDED|95.0|52.85|73.86||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% confidence interval (CI) of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|The primary efficacy analysis was the comparison of the relugolix plus E2/NETA group with the placebo group with respect to responder rate.||73.86|52.85|<0.0001
91649283|NCT03751124|183191034|OTHER|Stratified log-rank test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||P-value for comparison of relugolix plus E2/NETA to placebo was based on the stratified log-rank test.|Log Rank||Hazard ratio (95% CI) of relugolix plus E2/NETA to placebo was based on a proportional hazard model stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|||0.20|0.08|<0.0001
91649284|NCT03751124|183191035|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|58.04|||<|0.0001|TWO_SIDED|95.0|46.97|69.11||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% CI of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|||69.11|46.97|<0.0001
91649285|NCT03751124|183191036|SUPERIORITY||Treatment difference|44.12|||<|0.0001|TWO_SIDED|95.0|33.13|55.11||P-value for difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||55.11|33.13|<0.0001
91649286|NCT02462382|183191090|EQUIVALENCE|The univariate analyses were conducted using Independent t-Tests for continuous variables and Fisher Exact Tests or Chi-Square Tests of Independence for categorical comparisons.|Fisher Exact Tests|0.041||||0.006|TWO_SIDED|||||POD 1 1cm incision.|Chi-squared|||Comparisons of pain scores using a Visual Analog Scale (VAS) based on Post-Operative Day (POD).||||.006
91784258|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.14|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.19||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.19|0.10|<0.0001
91784259|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.2|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.33|0.20|<0.0001
91784260|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.19|0.28||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.28|0.19|<0.0001
91784261|NCT04518995|183449133|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.28|0.41||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.41|0.28|<0.0001
91784262|NCT04518995|183449134|SUPERIORITY||Least Square (LS) Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.13||0.0564|TWO_SIDED|95.0|-4.4|0.1||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||0.1|-4.4|0.0564
91596458|NCT00531752|183083503|SUPERIORITY_OR_OTHER||LS Mean Difference|1.025|STANDARD_ERROR_OF_MEAN|1.7713||0.5643|TWO_SIDED|80.0|-1.262|3.3121|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3121|-1.262|0.5643
91596459|NCT00531752|183083503|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9146|STANDARD_ERROR_OF_MEAN|1.8777||0.3107|TWO_SIDED|80.0|-0.51|4.3392|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.3392|-0.5100|0.3107
91596460|NCT00531752|183083503|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3154|STANDARD_ERROR_OF_MEAN|1.4638||0.1196|TWO_SIDED|80.0|0.41601|4.2148|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2148|0.41601|0.1196
91596461|NCT00531752|183083503|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3288|STANDARD_ERROR_OF_MEAN|1.524||0.3872|TWO_SIDED|80.0|-0.649|3.3065|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3065|-0.6490|0.3872
91596462|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1677|STANDARD_ERROR_OF_MEAN|1.0269||0.8708|TWO_SIDED|80.0|-1.162|1.4971|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4971|-1.162|0.8708
91596463|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8607|STANDARD_ERROR_OF_MEAN|1.0912||0.0927|TWO_SIDED|80.0|0.44874|3.2726|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2726|0.44874|0.0927
91596464|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.866|STANDARD_ERROR_OF_MEAN|0.9037||0.3405|TWO_SIDED|80.0|-0.3008|2.0329|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.0329|-0.3008|0.3405
91596465|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1623|STANDARD_ERROR_OF_MEAN|0.9622||0.8665|TWO_SIDED|80.0|-1.08|1.4047|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4047|-1.080|0.8665
91596466|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3886|STANDARD_ERROR_OF_MEAN|0.9694||0.6901|TWO_SIDED|80.0|-0.8694|1.6466|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6466|-0.8694|0.6901
91596467|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3779|STANDARD_ERROR_OF_MEAN|1.0114||0.179|TWO_SIDED|80.0|0.06498|2.6908|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.6908|0.06498|0.1790
91596468|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8759|STANDARD_ERROR_OF_MEAN|0.7508||0.0156|TWO_SIDED|80.0|0.90156|2.8502|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.8502|0.90156|0.0156
91596469|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04217|STANDARD_ERROR_OF_MEAN|0.7842||0.9573|TWO_SIDED|80.0|-1.06|0.97559|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.97559|-1.060|0.9573
91649287|NCT02496221|183191102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0021||||0.1229|TWO_SIDED|95.0|-20.5781|2.5739|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.5739|-20.5781|0.1229
91522187|NCT00514683|182919359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.478||0.4956|TWO_SIDED|95.0|-0.61|1.27|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.27|-0.61|0.4956
91596470|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1602|STANDARD_ERROR_OF_MEAN|1.2517||0.8986|TWO_SIDED|80.0|-1.462|1.782|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.7820|-1.462|0.8986
91596471|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6688|STANDARD_ERROR_OF_MEAN|1.3437||0.6204|TWO_SIDED|80.0|-1.071|2.4086|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4086|-1.071|0.6204
91596472|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.492|STANDARD_ERROR_OF_MEAN|0.8742||0.5759|TWO_SIDED|80.0|-0.6421|1.6261|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6261|-0.6421|0.5759
91596473|NCT00531752|183083508|SUPERIORITY_OR_OTHER||LS Mean Difference|0.875|STANDARD_ERROR_OF_MEAN|0.9488||0.3603|TWO_SIDED|80.0|-0.3552|2.1051|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1051|-0.3552|0.3603
91596474|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5306|STANDARD_ERROR_OF_MEAN|1.6664||0.0392|TWO_SIDED|80.0|1.3659|5.6952|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.6952|1.3659|0.0392
91596475|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9344|STANDARD_ERROR_OF_MEAN|1.7848||0.0003|TWO_SIDED|80.0|4.6177|9.2512|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.2512|4.6177|0.0003
91649288|NCT02496221|183191103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-545.9585||||0.1291|TWO_SIDED|95.0|-1260.0|168.0858|||Mixed Models Analysis|||||168.0858|-1260.00|0.1291
91596476|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2888|STANDARD_ERROR_OF_MEAN|2.1861||0.0547|TWO_SIDED|80.0|1.4544|7.1232|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1232|1.4544|0.0547
91596477|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6799|STANDARD_ERROR_OF_MEAN|2.3261||0.0176|TWO_SIDED|80.0|2.6655|8.6943|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6943|2.6655|0.0176
91596478|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7203|STANDARD_ERROR_OF_MEAN|2.5085||0.775|TWO_SIDED|80.0|-2.53|3.9704|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9704|-2.530|0.7750
91596479|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04276|STANDARD_ERROR_OF_MEAN|2.6874||0.9874|TWO_SIDED|80.0|-3.521|3.4357|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.4357|-3.521|0.9874
91596480|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6252|STANDARD_ERROR_OF_MEAN|2.2268||0.7799|TWO_SIDED|80.0|-3.513|2.2629|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.2629|-3.513|0.7799
91596481|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1136|STANDARD_ERROR_OF_MEAN|2.3365||0.1881|TWO_SIDED|80.0|0.08338|6.1438|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1438|0.08338|0.1881
91596482|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6575|STANDARD_ERROR_OF_MEAN|1.9677||0.4032|TWO_SIDED|80.0|-0.8944|4.2094|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2094|-0.8944|0.4032
91596483|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9254|STANDARD_ERROR_OF_MEAN|2.0796||0.0059|TWO_SIDED|80.0|3.2314|8.6193|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6193|3.2314|0.0059
91596484|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0921|STANDARD_ERROR_OF_MEAN|2.1098||0.6067|TWO_SIDED|80.0|-1.643|3.8273|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8273|-1.643|0.6067
91596485|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2785|STANDARD_ERROR_OF_MEAN|2.2424||0.0614|TWO_SIDED|80.0|1.3709|7.186|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1860|1.3709|0.0614
91596486|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7149|STANDARD_ERROR_OF_MEAN|2.2086||0.7476|TWO_SIDED|80.0|-3.584|2.1546|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1546|-3.584|0.7476
91596487|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3355|STANDARD_ERROR_OF_MEAN|2.4396||0.5863|TWO_SIDED|80.0|-4.499|1.8284|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.8284|-4.499|0.5863
91596488|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1058|STANDARD_ERROR_OF_MEAN|2.0529||0.9591|TWO_SIDED|80.0|-2.771|2.5593|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.5593|-2.771|0.9591
91596489|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4352|STANDARD_ERROR_OF_MEAN|2.2048||0.8442|TWO_SIDED|80.0|-3.294|2.4238|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4238|-3.294|0.8442
91596490|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6876|STANDARD_ERROR_OF_MEAN|2.0533||0.1977|TWO_SIDED|80.0|0.01391|5.3613|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.3613|0.01391|0.1977
91596491|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8149|STANDARD_ERROR_OF_MEAN|2.2467||0.4235|TWO_SIDED|80.0|-1.108|4.7375|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.7375|-1.108|0.4235
91596492|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6424|STANDARD_ERROR_OF_MEAN|1.9753||0.1882|TWO_SIDED|80.0|0.07015|5.2147|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2147|0.07015|0.1882
91649289|NCT02496221|183191105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2992||||0.0317|TWO_SIDED|95.0|-31.0762|-1.5223|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||-1.5223|-31.0762|0.0317
91596493|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2105|STANDARD_ERROR_OF_MEAN|2.0376||0.5555|TWO_SIDED|80.0|-1.44|3.8615|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8615|-1.440|0.5555
91596494|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1804|STANDARD_ERROR_OF_MEAN|2.1934||0.1533|TWO_SIDED|80.0|0.33169|6.0292|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0292|0.33169|0.1533
91596495|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0511|STANDARD_ERROR_OF_MEAN|2.2662||0.3697|TWO_SIDED|80.0|-0.8912|4.9934|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.9934|-0.8912|0.3697
91649290|NCT02496221|183191106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|252.6099||||0.0291|TWO_SIDED|95.0|29.5081|475.7117|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||475.7117|29.5081|0.0291
91649291|NCT02496221|183191107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3748||||0.7961|TWO_SIDED|95.0|-3.4109|2.6614|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.6614|-3.4109|0.7961
91522188|NCT00514683|182919359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.482||0.0051|TWO_SIDED|95.0|0.41|2.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.31|0.41|0.0051
91522189|NCT00514683|182919359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.483||0.0211|TWO_SIDED|95.0|0.17|2.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.07|0.17|0.0211
91522190|NCT00514683|182919360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.428||||0.1021|TWO_SIDED|95.0|0.155|1.184|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.184|0.155|0.1021
91522191|NCT00514683|182919360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.682||||0.4318|TWO_SIDED|95.0|0.262|1.773|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.773|0.262|0.4318
91522192|NCT00514683|182919360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.412||||0.0934|TWO_SIDED|95.0|0.146|1.161|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.161|0.146|0.0934
91522193|NCT00514683|182919360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.313||||0.0317|TWO_SIDED|95.0|0.108|0.903|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.903|0.108|0.0317
91522194|NCT00514683|182919361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|2.33||0.6443|TWO_SIDED|95.0|-5.66|3.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.51|-5.66|0.6443
91522195|NCT00514683|182919361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|2.28||0.5656|TWO_SIDED|95.0|-5.8|3.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.18|-5.80|0.5656
91522196|NCT00514683|182919361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|2.24||0.9181|TWO_SIDED|95.0|-4.18|4.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.64|-4.18|0.9181
91522197|NCT00514683|182919361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.387||0.697|TWO_SIDED|95.0|-3.77|5.63|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.63|-3.77|0.6970
91522198|NCT00514683|182919362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|2.49||0.9811|TWO_SIDED|95.0|-4.84|4.96|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.96|-4.84|0.9811
91522199|NCT00514683|182919362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|2.412||0.6772|TWO_SIDED|95.0|-3.74|5.75|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.75|-3.74|0.6772
91522200|NCT00514683|182919362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|2.379||0.8631|TWO_SIDED|95.0|-4.27|5.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.09|-4.27|0.8631
91522201|NCT00514683|182919362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|2.523||0.5942|TWO_SIDED|95.0|-3.62|6.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||6.31|-3.62|0.5942
91522202|NCT00514683|182919363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.715||0.2716|TWO_SIDED|95.0|-0.62|2.19|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.19|-0.62|0.2716
91522203|NCT00514683|182919363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.696||0.7871|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.56|-1.18|0.7871
91522204|NCT00514683|182919363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.685||0.8721|TWO_SIDED|95.0|-1.46|1.24|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.24|-1.46|0.8721
91522205|NCT00514683|182919363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.734||0.8523|TWO_SIDED|95.0|-1.58|1.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.31|-1.58|0.8523
91522206|NCT00514683|182919364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.7997|TWO_SIDED|95.0|0.549|2.175|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.175|0.549|0.7997
91649292|NCT02496221|183191109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001526||||0.9424|TWO_SIDED|95.0|-0.045665|0.048717|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.048717|-0.045665|0.9424
91649293|NCT02496221|183191110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01456||||0.0733|TWO_SIDED|95.0|-0.030666|0.001554|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.001554|-0.030666|0.0733
91649294|NCT01335399|183191117|SUPERIORITY|||||||0.4358|||||||Stratified Log Rank|||||||0.4358
91596496|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|1.764|STANDARD_ERROR_OF_MEAN|2.3939||0.4652|TWO_SIDED|80.0|-1.352|4.8801|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.8801|-1.352|0.4652
91596497|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4377|STANDARD_ERROR_OF_MEAN|2.5148||0.8626|TWO_SIDED|80.0|-2.83|3.7058|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.7058|-2.830|0.8626
91596498|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7114|STANDARD_ERROR_OF_MEAN|1.6168||0.0261|TWO_SIDED|80.0|1.6105|5.8122|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.8122|1.6105|0.0261
91596499|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2644|STANDARD_ERROR_OF_MEAN|1.7026||0.1895|TWO_SIDED|80.0|0.0533|4.4756|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.4756|0.05330|0.1895
91596500|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1151|STANDARD_ERROR_OF_MEAN|3.0732||0.4994|TWO_SIDED|80.0|-1.961|6.1913|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1913|-1.961|0.4994
91596501|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5616|STANDARD_ERROR_OF_MEAN|3.3113||0.2945|TWO_SIDED|80.0|-0.8226|7.9458|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.9458|-0.8226|0.2945
91596502|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7306|STANDARD_ERROR_OF_MEAN|2.9257||0.8056|TWO_SIDED|80.0|-4.622|3.1613|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1613|-4.622|0.8056
91596503|NCT00531752|183083509|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3672|STANDARD_ERROR_OF_MEAN|3.8657||0.3922|TWO_SIDED|80.0|-1.725|8.4592|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.4592|-1.725|0.3922
91596504|NCT00531752|183083510|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5069|STANDARD_ERROR_OF_MEAN|0.8744||0.0913|TWO_SIDED|80.0|-2.643|-0.3705|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3705|-2.643|0.0913
91596505|NCT00531752|183083510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2078|STANDARD_ERROR_OF_MEAN|0.9165||0.8216|TWO_SIDED|80.0|-1.399|0.98326|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.98326|-1.399|0.8216
91596506|NCT00531752|183083511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4181|STANDARD_ERROR_OF_MEAN|0.6887||0.5466|TWO_SIDED|80.0|-1.313|0.47668|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.47668|-1.313|0.5466
91649295|NCT01335399|183191117|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.71|0.77|1.12|||||E-Ld/Ld. Calculated using Cox proportional hazards modeling|||1.12|0.77|
91596507|NCT00531752|183083511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02518|STANDARD_ERROR_OF_MEAN|0.6772||0.9705|TWO_SIDED|80.0|-0.9035|0.85312|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.85312|-0.9035|0.9705
91596508|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09953|STANDARD_ERROR_OF_MEAN|0.3001||0.7415|TWO_SIDED|80.0|-0.4892|0.29012|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29012|-0.4892|0.7415
91596509|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04804|STANDARD_ERROR_OF_MEAN|0.3227||0.8822|TWO_SIDED|80.0|-0.3703|0.4664|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46640|-0.3703|0.8822
91596510|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.125|STANDARD_ERROR_OF_MEAN|0.1302||0.3414|TWO_SIDED|80.0|-0.0439|0.29385|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29385|-0.0439|0.3414
91596511|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1044|STANDARD_ERROR_OF_MEAN|0.1418||0.4642|TWO_SIDED|80.0|-0.0793|0.28814|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.28814|-0.0793|0.4642
91649296|NCT01335399|183191118|SUPERIORITY||CMH ESTIMATE OF COMMON ODDS RATIO|1.26||||0.2232|TWO_SIDED|95.0|0.87|1.82|||CMH ESTIMATE OF COMMON ODDS RATIO|||||1.82|0.87|0.2232
91596512|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06109|STANDARD_ERROR_OF_MEAN|0.09093||0.5049|TWO_SIDED|80.0|-0.0571|0.17926|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.17926|-0.0571|0.5049
91596513|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07917|STANDARD_ERROR_OF_MEAN|0.1002||0.4332|TWO_SIDED|80.0|-0.051|0.2093|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.20930|-0.0510|0.4332
91596514|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2453|STANDARD_ERROR_OF_MEAN|0.1753||0.1678|TWO_SIDED|80.0|-0.473|-0.0177|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0177|-0.4730|0.1678
91596515|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07717|STANDARD_ERROR_OF_MEAN|0.1925||0.6901|TWO_SIDED|80.0|-0.1726|0.32695|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.32695|-0.1726|0.6901
91596516|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1702|STANDARD_ERROR_OF_MEAN|1.354||0.9005|TWO_SIDED|80.0|-1.587|1.9274|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.9274|-1.587|0.9005
91596517|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4317|STANDARD_ERROR_OF_MEAN|1.4667||0.333|TWO_SIDED|80.0|-3.333|0.46937|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46937|-3.333|0.3330
91596518|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6537|STANDARD_ERROR_OF_MEAN|2.0857||0.7551|TWO_SIDED|80.0|-2.051|3.3584|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3584|-2.051|0.7551
91596519|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8639|STANDARD_ERROR_OF_MEAN|2.2354||0.0334|TWO_SIDED|80.0|-7.759|-1.968|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.968|-7.759|0.0334
91596520|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6389|STANDARD_ERROR_OF_MEAN|3.6119||0.6519|TWO_SIDED|80.0|-3.05|6.3281|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3281|-3.050|0.6519
91596521|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2007|STANDARD_ERROR_OF_MEAN|3.9647||0.7631|TWO_SIDED|80.0|-3.941|6.3423|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3423|-3.941|0.7631
91596522|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9211|STANDARD_ERROR_OF_MEAN|2.8206||0.3034|TWO_SIDED|80.0|-0.7227|6.5648|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5648|-0.7227|0.3034
91596523|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0968|STANDARD_ERROR_OF_MEAN|3.0022||0.0933|TWO_SIDED|80.0|-8.975|-1.218|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.218|-8.975|0.0933
91596524|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0675|STANDARD_ERROR_OF_MEAN|2.9778||0.0949|TWO_SIDED|80.0|-8.934|-1.201|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.201|-8.934|0.0949
91649297|NCT01335399|183191119|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8932|TWO_SIDED|95.0|0.82|1.19|||Stratified log rank test||Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.|||1.19|0.82|0.8932
91522207|NCT00514683|182919364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.7989|TWO_SIDED|95.0|0.467|1.797|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.797|0.467|0.7989
91596525|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3274|STANDARD_ERROR_OF_MEAN|3.2552||0.0283|TWO_SIDED|80.0|-11.55|-3.106|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-3.106|-11.55|0.0283
91596526|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1505|STANDARD_ERROR_OF_MEAN|1.5974||0.1852|TWO_SIDED|80.0|-4.229|-0.0719|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0719|-4.229|0.1852
91596527|NCT00531752|183083512|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5178|STANDARD_ERROR_OF_MEAN|1.7732||0.1623|TWO_SIDED|80.0|-4.823|-0.2127|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2127|-4.823|0.1623
91596528|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.5791|STANDARD_ERROR_OF_MEAN|18.0449||0.5241|TWO_SIDED|80.0|-35.02|11.86|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||11.860|-35.02|0.5241
91649298|NCT01335399|183191121|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.4358|TWO_SIDED|95.0|0.78|1.12|||Hazard Ratio|||||1.12|0.78|0.4358
91522208|NCT00514683|182919364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4596|TWO_SIDED|95.0|0.403|1.508|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.508|0.403|0.4596
91596529|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.3367|STANDARD_ERROR_OF_MEAN|19.6995||0.3065|TWO_SIDED|80.0|-45.89|5.2183|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2183|-45.89|0.3065
91596530|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7878|STANDARD_ERROR_OF_MEAN|13.4438||0.3831|TWO_SIDED|80.0|-29.15|5.5793|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5793|-29.15|0.3831
91596531|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.1401|STANDARD_ERROR_OF_MEAN|14.4478||0.3657|TWO_SIDED|80.0|-31.8|5.5241|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5241|-31.80|0.3657
91596532|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|2.666|STANDARD_ERROR_OF_MEAN|11.5818||0.8188|TWO_SIDED|80.0|-12.36|17.69|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||17.690|-12.36|0.8188
91596533|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|24.1011|STANDARD_ERROR_OF_MEAN|12.405||0.0566|TWO_SIDED|80.0|8.0305|40.172|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||40.172|8.0305|0.0566
91596534|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7559|STANDARD_ERROR_OF_MEAN|8.7164||0.9312|TWO_SIDED|80.0|-10.55|12.057|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.057|-10.55|0.9312
91596535|NCT00531752|183083513|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1138|STANDARD_ERROR_OF_MEAN|9.4361||0.5194|TWO_SIDED|80.0|-6.108|18.336|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||18.336|-6.108|0.5194
91596536|NCT00531752|183083514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3255|STANDARD_ERROR_OF_MEAN|0.332||0.332|TWO_SIDED|80.0|-0.7573|0.10622|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.10622|-0.7573|0.3320
91596537|NCT00531752|183083514|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4255|STANDARD_ERROR_OF_MEAN|0.3871||0.2767|TWO_SIDED|80.0|-0.0769|0.92804|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.92804|-0.0769|0.2767
91649299|NCT01893983|183191122|EQUIVALENCE|Compare whether 2 groups had any difference in risk/hazard of mental health engagement at any time during follow-up.|Cox Proportional Hazard|1.13||||0.66|TWO_SIDED|95.0|0.81|1.58||P value 0.05 is the threshold for statistical significance|Regression, Cox|Adjusted for site, mental health treatment history and mental health symptom severity at baseline, baseline amphetamine and opioid scores.|The referral alone arm is the reference group (denominator), and the motivational coaching arm is the numerator.|Compare 2 groups in regard to time to first mental health treatment using Cox proportional hazards regression.||1.58|0.81|0.660
91596538|NCT00531752|183083514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3661|STANDARD_ERROR_OF_MEAN|0.4028||0.3675|TWO_SIDED|80.0|-0.8887|0.1566|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.15660|-0.8887|0.3675
91649300|NCT01120600|183191126|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.59|||<|0.001|TWO_SIDED|95.0|4.48|6.7|||cLDA|||A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||6.7|4.48|< 0.001
91596539|NCT00531752|183083514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1033|STANDARD_ERROR_OF_MEAN|0.4372||0.8141|TWO_SIDED|80.0|-0.67|0.46345|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46345|-0.6700|0.8141
91596540|NCT00531752|183083514|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1854|STANDARD_ERROR_OF_MEAN|0.3702||0.6186|TWO_SIDED|80.0|-0.6657|0.29495|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29495|-0.6657|0.6186
91596541|NCT00531752|183083514|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3623|STANDARD_ERROR_OF_MEAN|0.4028||0.372|TWO_SIDED|80.0|-0.1597|0.88432|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.88432|-0.1597|0.3720
91596542|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0781|STANDARD_ERROR_OF_MEAN|5.0238|<|0.0001|TWO_SIDED|80.0|18.565|31.591|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.591|18.565|<0.0001
91596543|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|15.6481|STANDARD_ERROR_OF_MEAN|5.3551||0.0049|TWO_SIDED|80.0|8.711|22.585|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||22.585|8.7110|0.0049
91596544|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.627|STANDARD_ERROR_OF_MEAN|3.5248||0.3078|TWO_SIDED|80.0|-8.196|0.94237|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.94237|-8.196|0.3078
91596545|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1594|STANDARD_ERROR_OF_MEAN|3.8022||0.0644|TWO_SIDED|80.0|2.2344|12.084|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.084|2.2344|0.0644
91522209|NCT00514683|182919364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.665||||0.2548|TWO_SIDED|95.0|0.33|1.341|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.341|0.330|0.2548
91596546|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5601|STANDARD_ERROR_OF_MEAN|3.1318||0.1517|TWO_SIDED|80.0|0.49198|8.6281|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6281|0.49198|0.1517
91596547|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7384|STANDARD_ERROR_OF_MEAN|3.3281||0.8252|TWO_SIDED|80.0|-5.056|3.5789|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.5789|-5.056|0.8252
91596548|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6228|STANDARD_ERROR_OF_MEAN|0.2203||0.0063|TWO_SIDED|80.0|-0.9082|-0.3375|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3375|-0.9082|0.0063
91596549|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2301|STANDARD_ERROR_OF_MEAN|0.2303||0.3217|TWO_SIDED|80.0|-0.5283|0.06822|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.06822|-0.5283|0.3217
91596550|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1291|STANDARD_ERROR_OF_MEAN|0.1065||0.2307|TWO_SIDED|80.0|-0.0091|0.26716|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.26716|-0.0091|0.2307
91596551|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
91596552|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6629|STANDARD_ERROR_OF_MEAN|3.8642||0.3477|TWO_SIDED|80.0|-8.681|1.3549|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.3549|-8.681|0.3477
91596553|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8688|STANDARD_ERROR_OF_MEAN|4.0842||0.1565|TWO_SIDED|80.0|-11.17|-0.5693|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5693|-11.17|0.1565
91596554|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4319|STANDARD_ERROR_OF_MEAN|3.9541||0.1088|TWO_SIDED|80.0|-11.55|-1.311|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.311|-11.55|0.1088
91596555|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|4.1517||0.8627|TWO_SIDED|80.0|-4.654|6.0952|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0952|-4.654|0.8627
91784263|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.23||0.0054|TWO_SIDED|95.0|-5.9|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.0|-5.9|0.0054
91596556|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|56.631|STANDARD_ERROR_OF_MEAN|17.8056||0.0024|TWO_SIDED|80.0|33.532|79.73|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||79.730|33.532|0.0024
91596557|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|49.1543|STANDARD_ERROR_OF_MEAN|18.7622||0.0112|TWO_SIDED|80.0|24.831|73.478|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||73.478|24.831|0.0112
91596558|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9197|STANDARD_ERROR_OF_MEAN|3.0912||0.0008|TWO_SIDED|80.0|6.9105|14.929|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.929|6.9105|0.0008
91784264|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED|95.0|-12.7|-4.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-4.3|-12.7|<0.0001
91784265|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.34|<|0.0001|TWO_SIDED|95.0|-19.5|-10.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-10.3|-19.5|<0.0001
91784266|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-21.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-27.5|-16.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-16.0|-27.5|<0.0001
91784267|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-36.3|-23.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-23.8|-36.3|<0.0001
91784268|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|3.38|<|0.0001|TWO_SIDED|95.0|-35.1|-21.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-21.8|-35.1|<0.0001
91784269|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.7|-31.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-31.3|-45.7|<0.0001
91784270|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-34.9|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-27.7|-42.1|<0.0001
91596559|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4691|STANDARD_ERROR_OF_MEAN|3.3037||0.0129|TWO_SIDED|80.0|4.1876|12.751|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.751|4.1876|0.0129
91596560|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1078|STANDARD_ERROR_OF_MEAN|4.3667||0.002|TWO_SIDED|80.0|8.4492|19.766|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||19.766|8.4492|0.0020
91596561|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3485|STANDARD_ERROR_OF_MEAN|4.5692||0.0026|TWO_SIDED|80.0|8.4275|20.27|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||20.270|8.4275|0.0026
91596562|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2989|STANDARD_ERROR_OF_MEAN|3.4103||0.9305|TWO_SIDED|80.0|-4.729|4.1309|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.1309|-4.729|0.9305
91596563|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7062|STANDARD_ERROR_OF_MEAN|3.5839||0.1178|TWO_SIDED|80.0|-10.36|-1.05|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.050|-10.36|0.1178
91596564|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4586|STANDARD_ERROR_OF_MEAN|2.5231||0.3339|TWO_SIDED|80.0|-0.8124|5.7295|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.7295|-0.8124|0.3339
91596565|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.63||0.0698|TWO_SIDED|80.0|1.4493|8.2686|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.2686|1.4493|0.0698
91596566|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3364|STANDARD_ERROR_OF_MEAN|0.1859||0.0762|TWO_SIDED|80.0|-0.5777|-0.095|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0950|-0.5777|0.0762
91596567|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1591|STANDARD_ERROR_OF_MEAN|0.1913||0.4096|TWO_SIDED|80.0|-0.4075|0.08935|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.08935|-0.4075|0.4096
91596568|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2115|STANDARD_ERROR_OF_MEAN|0.1033||0.0455|TWO_SIDED|80.0|0.07751|0.3455|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.34550|0.07751|0.0455
91596569|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
91596570|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5433|STANDARD_ERROR_OF_MEAN|4.6662||0.9078|TWO_SIDED|80.0|-5.513|6.5995|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5995|-5.513|0.9078
91596571|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1848|STANDARD_ERROR_OF_MEAN|4.7892||0.6502|TWO_SIDED|80.0|-8.403|4.0338|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0338|-8.403|0.6502
91784271|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.96|<|0.0001|TWO_SIDED|95.0|-52.3|-36.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-36.8|-52.3|<0.0001
91784272|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.0001|TWO_SIDED|95.0|-46.7|-31.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-31.8|-46.7|<0.0001
91784273|NCT04518995|183449134|SUPERIORITY||LS Mean Difference|-47.0|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-55.1|-39.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-39.0|-55.1|<0.0001
91596572|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9029|STANDARD_ERROR_OF_MEAN|3.7234||0.809|TWO_SIDED|80.0|-5.716|3.9101|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9101|-5.716|0.8090
91596573|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4351|STANDARD_ERROR_OF_MEAN|3.8429||0.5282|TWO_SIDED|80.0|-2.532|7.4025|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.4025|-2.532|0.5282
91596574|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3231|STANDARD_ERROR_OF_MEAN|18.8604||0.1848|TWO_SIDED|80.0|0.86393|49.782|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||49.782|0.86393|0.1848
91784274|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91784275|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91596575|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|50.4054|STANDARD_ERROR_OF_MEAN|19.481||0.0124|TWO_SIDED|80.0|25.134|75.677|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||75.677|25.134|0.0124
91596576|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8658|STANDARD_ERROR_OF_MEAN|3.0205||0.0267|TWO_SIDED|80.0|2.9504|10.781|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.781|2.9504|0.0267
91596577|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|8.0855|STANDARD_ERROR_OF_MEAN|3.1677||0.0134|TWO_SIDED|80.0|3.9787|12.192|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.192|3.9787|0.0134
91596578|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5242|STANDARD_ERROR_OF_MEAN|3.7993||0.0152|TWO_SIDED|80.0|4.5949|14.453|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.453|4.5949|0.0152
91596579|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9806|STANDARD_ERROR_OF_MEAN|4.1501|<|0.0001|TWO_SIDED|80.0|14.602|25.359|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||25.359|14.602|<.0001
91596580|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7667|STANDARD_ERROR_OF_MEAN|2.9402||0.3516|TWO_SIDED|80.0|-6.59|1.0562|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.0562|-6.590|0.3516
91649301|NCT01120600|183191127|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.02|||<|0.001|TWO_SIDED|95.0|1.27|2.77|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.77|1.27|< 0.001
91649302|NCT01120600|183191128|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.69|||=|0.008|TWO_SIDED|95.0|0.45|2.93|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.93|0.45|= 0.008
91709318|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.198|TWO_SIDED|95.0|-0.49|0.1|||Repeated measure model|||2 asthma exacerbations in the past year||0.10|-0.49|0.198
91784276|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
91784277|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
91784278|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91784279|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91784280|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
91784281|NCT04518995|183449135|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
91784282|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91596581|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0838|STANDARD_ERROR_OF_MEAN|3.2323||0.3448|TWO_SIDED|80.0|-1.116|7.2838|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.2838|-1.116|0.3448
91784283|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91784284|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
91784285|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
91784286|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91649303|NCT01120600|183191129|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.12|||<|0.001|TWO_SIDED|95.0|0.93|3.3|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||3.3|0.93|< 0.001
91649304|NCT01120600|183191130|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-76.58|||<|0.001|TWO_SIDED|95.0|-92.56|-60.61|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-60.61|-92.56|< 0.001
91649305|NCT01120600|183191131|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-68.08|||<|0.001|TWO_SIDED|95.0|-78.1|-58.06|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-58.06|-78.1|< 0.001
91649306|NCT01120600|183191132|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.94|||=|0.019|TWO_SIDED|95.0|-14.58|-1.31|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-1.31|-14.58|= 0.019
91649307|NCT01120600|183191133|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.0|||=|0.001|TWO_SIDED|95.0|-25.74|-6.27|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-6.27|-25.74|= 0.001
91649308|NCT02544633|183191187|SUPERIORITY|An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR \<=20% against H1: ORR \>20%.|Objective response rate|10.7||||0.94|TWO_SIDED|95.0|2.27|28.23|||exact test|||||28.23|2.27|0.94
91649309|NCT02544633|183191187|SUPERIORITY||Objective response rate|15.0||||0.79|TWO_SIDED|95.0|3.21|37.89|||exact test|||||37.89|3.21|0.79
91649310|NCT02544633|183191187|SUPERIORITY||Objective response rate|25.0||||0.47|TWO_SIDED|95.0|3.19|65.09|||Exact Test|||||65.09|3.19|0.47
91649311|NCT02544633|183191187|SUPERIORITY||Objective response rate|0.0|||>|0.999|TWO_SIDED|95.0|0.0|26.46|||Exact test|||||26.46|0.00|>0.999
91649312|NCT02092961|183191204|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.022|TWO_SIDED|90.0|-2.75|-0.42||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||-0.42|-2.75|0.022
91649313|NCT02092961|183191204|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.402|TWO_SIDED|90.0|-1.0|2.0||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.00|-1.00|0.402
91649314|NCT02092961|183191205|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.746|TWO_SIDED|90.0|-1.0|0.5||A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.50|-1.00|0.746
91649315|NCT02092961|183191205|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.413|TWO_SIDED|90.0|-1.5|3.5||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||3.50|-1.50|0.413
91649316|NCT02092961|183191206|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.491|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|0.00|0.491
91649317|NCT02092961|183191206|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.341|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||0.00|0.00|0.341
91709319|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.18||||0.226|TWO_SIDED|95.0|-0.47|0.11|||Repeated measure model|||2 asthma exacerbations in the past year||0.11|-0.47|0.226
91709320|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.14||||0.513|TWO_SIDED|95.0|-0.56|0.28|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.28|-0.56|0.513
91522210|NCT00514683|182919365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.051||||0.8887|TWO_SIDED|95.0|0.521|2.122|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.122|0.521|0.8887
91596582|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5882|STANDARD_ERROR_OF_MEAN|4.3902||0.5583|TWO_SIDED|80.0|-8.294|3.1175|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1175|-8.294|0.5583
91596583|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6547|STANDARD_ERROR_OF_MEAN|4.7652||0.1141|TWO_SIDED|80.0|1.4717|13.838|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.838|1.4717|0.1141
91596584|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5882|STANDARD_ERROR_OF_MEAN|0.1903||0.0034|TWO_SIDED|80.0|-0.8356|-0.3408|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3408|-0.8356|0.0034
91613590|NCT00916721|183121479|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Multiple significance testing:we adjusted p-value by controlling the expected proportion of falsely rejected hypotheses:false discovery rate,Benjamini||||||0.05
91613591|NCT00121810|183121488|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.7||||0.012||95.0|4.2|33.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.||33.2|4.2|0.012
91613592|NCT00121810|183121489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.543||95.0|-9.6|18.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||||18.2|-9.6|0.543
91613593|NCT00121810|183121490|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.8||||0.003||95.0|-17.9|-3.7||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||-3.7|-17.9|0.003
91613594|NCT00121810|183121490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.0||||0.108||95.0|-35.4|3.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||3.5|-35.4|0.108
91709321|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.974|TWO_SIDED|95.0|-0.43|0.42|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.42|-0.43|0.974
91522211|NCT00514683|182919365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.216||||0.5758|TWO_SIDED|95.0|0.613|2.41|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.410|0.613|0.5758
91522212|NCT00514683|182919365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.993||||0.9829|TWO_SIDED|95.0|0.506|1.949|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.949|0.506|0.9829
91522213|NCT00514683|182919365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.9375|TWO_SIDED|95.0|0.476|1.985|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.985|0.476|0.9375
91522214|NCT00514683|182919366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.1456||0.4998|TWO_SIDED|95.0|-0.188|0.385|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.385|-0.188|0.4998
91522215|NCT00514683|182919366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.1399||0.2679|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.120|-0.430|0.2679
91522216|NCT00514683|182919366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5678|TWO_SIDED|95.0|-0.355|0.195|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.195|-0.355|0.5678
91522217|NCT00514683|182919366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.1448||0.4053|TWO_SIDED|95.0|-0.406|0.164|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.164|-0.406|0.4053
91522218|NCT00514683|182919367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.892||||0.7307|TWO_SIDED|95.0|0.465|1.71|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.710|0.465|0.7307
91522219|NCT00514683|182919367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.317||||0.3869|TWO_SIDED|95.0|0.706|2.458|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.458|0.706|0.3869
91522220|NCT00514683|182919367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.8237|TWO_SIDED|95.0|0.498|1.741|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.741|0.498|0.8237
91522221|NCT00514683|182919367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.676||||0.1177|TWO_SIDED|95.0|0.878|3.202|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||3.202|0.878|0.1177
91522222|NCT00514683|182919368|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-11.24|STANDARD_ERROR_OF_MEAN|17.089||0.5111|TWO_SIDED|95.0|-44.86|22.37|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||22.37|-44.86|0.5111
91522223|NCT00514683|182919368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|16.234||0.4176|TWO_SIDED|95.0|-45.11|18.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||18.76|-45.11|0.4176
91522224|NCT00514683|182919368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|16.506||0.9454|TWO_SIDED|95.0|-33.6|31.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||31.34|-33.60|0.9454
91522225|NCT00514683|182919368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32|STANDARD_ERROR_OF_MEAN|16.98||0.7101|TWO_SIDED|95.0|-27.08|39.72|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||39.72|-27.08|0.7101
91522226|NCT00514683|182919369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.2271||0.809|TWO_SIDED|95.0|-0.392|0.502|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.502|-0.392|0.8090
91522227|NCT00514683|182919369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.2158||0.3995|TWO_SIDED|95.0|-0.606|0.242|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.242|-0.606|0.3995
91522228|NCT00514683|182919369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.2193||0.8822|TWO_SIDED|95.0|-0.399|0.464|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.464|-0.399|0.8822
91709322|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.226|TWO_SIDED|95.0|-0.97|0.23|||Repeated measure model|||Chronic OCS use||0.23|-0.97|0.226
91709323|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.15||||0.613|TWO_SIDED|95.0|-0.44|0.75|||Repeated measure model|||Chronic OCS use||0.75|-0.44|0.613
91709324|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.198|TWO_SIDED|95.0|-0.43|0.09|||Repeated measure model|||Without chronic OCS use||0.09|-0.43|0.198
91649318|NCT02092961|183191207|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.366|TWO_SIDED|90.0|-0.5|0.0||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|-0.50|0.366
91649319|NCT02092961|183191207|SUPERIORITY_OR_OTHER||Treatment difference|1.25||||0.053|TWO_SIDED|90.0|0.5|2.5||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.50|0.50|0.053
91649320|NCT02092961|183191208|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|0.89||||0.006|TWO_SIDED|90.0|0.36|1.41|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||1.41|0.36|0.006
91649321|NCT02092961|183191208|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|-0.34||||0.496|TWO_SIDED|90.0|-1.16|0.49|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||0.49|-1.16|0.496
91649322|NCT01625845|183191255|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|95.0|||||ANCOVA|||||||.474
91596585|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1722|STANDARD_ERROR_OF_MEAN|0.2064||0.4083|TWO_SIDED|80.0|-0.4403|0.09599|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.09599|-0.4403|0.4083
91596586|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2744|STANDARD_ERROR_OF_MEAN|0.1055||0.012|TWO_SIDED|80.0|0.13746|0.41127|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.41127|0.13746|0.0120
91596587|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1016|STANDARD_ERROR_OF_MEAN|0.1136||0.375|TWO_SIDED|80.0|-0.0457|0.24881|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.24881|-0.0457|0.3750
91596588|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4367|STANDARD_ERROR_OF_MEAN|3.9301||0.9119|TWO_SIDED|80.0|-4.665|5.5387|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5387|-4.665|0.9119
91649323|NCT01625845|183191256|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||ANCOVA|||||||.068
91522229|NCT00514683|182919369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.2257||0.5338|TWO_SIDED|95.0|-0.584|0.303|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.303|-0.584|0.5338
91596589|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3429|STANDARD_ERROR_OF_MEAN|4.1977||0.1367|TWO_SIDED|80.0|-11.79|-0.896|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.8960|-11.79|0.1367
91596590|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0062|STANDARD_ERROR_OF_MEAN|3.1094||0.0595|TWO_SIDED|80.0|-10.05|-1.964|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.964|-10.05|0.0595
91649324|NCT01625845|183191257|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED|95.0|||||ANCOVA|||||||.296
91649325|NCT01625845|183191258|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|95.0|||||ANCOVA|||||||.203
91522230|NCT00514683|182919370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.3272||0.7329|TWO_SIDED|95.0|-0.532|0.755|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.755|-0.532|0.7329
91649326|NCT01625845|183191259|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||ANCOVA|||||||.906
91649327|NCT01625845|183191260|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED|95.0|||||ANCOVA|||||||.869
91649328|NCT01625845|183191261|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||ANCOVA|||||||.026
91596591|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0362|STANDARD_ERROR_OF_MEAN|3.3182||0.1356|TWO_SIDED|80.0|0.72505|9.3473|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.3473|0.72505|0.1356
91649329|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.8|-1.7||Month 1|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.7|-2.8|<0.001
91649330|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.7|-1.5||Month 3|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.5|-2.7|<0.001
91709325|NCT01402986|183311374|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.165|TWO_SIDED|95.0|-0.45|0.08|||Repeated measure model|||Without chronic OCS use||0.08|-0.45|0.165
91596592|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1569|STANDARD_ERROR_OF_MEAN|16.2884||0.7528|TWO_SIDED|80.0|-15.99|26.303|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||26.303|-15.99|0.7528
91596593|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|67.7022|STANDARD_ERROR_OF_MEAN|17.4066||0.0003|TWO_SIDED|80.0|45.114|90.29|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||90.290|45.114|0.0003
91596594|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8582|STANDARD_ERROR_OF_MEAN|2.6389||0.2837|TWO_SIDED|80.0|-0.567|6.2835|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.2835|-0.5670|0.2837
91596595|NCT00531752|183083515|SUPERIORITY_OR_OTHER||LS Mean Difference|12.9251|STANDARD_ERROR_OF_MEAN|2.8913|<|0.0001|TWO_SIDED|80.0|9.1761|16.674|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||16.674|9.1761|<0.0001
91596596|NCT00531752|183083516|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8615|STANDARD_ERROR_OF_MEAN|3.9167|<|0.0001|TWO_SIDED|80.0|21.777|31.946|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.946|21.777|<0.0001
91596597|NCT00531752|183083516|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3455|STANDARD_ERROR_OF_MEAN|4.1817||0.3034|TWO_SIDED|80.0|-1.08|9.7713|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.7713|-1.080|0.3034
91596598|NCT00531752|183083516|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9558|STANDARD_ERROR_OF_MEAN|2.9408||0.0223|TWO_SIDED|80.0|3.132|10.78|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.780|3.1320|0.0223
91596599|NCT00531752|183083516|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7518|STANDARD_ERROR_OF_MEAN|3.0743||0.2284|TWO_SIDED|80.0|-0.2442|7.7479|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.7479|-0.2442|0.2284
91649331|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.9||Month 6|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-0.9|-2.1|<0.001
91649332|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 9|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
91596600|NCT00531752|183083516|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5752|STANDARD_ERROR_OF_MEAN|3.5848||0.0201|TWO_SIDED|80.0|3.9265|13.224|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.224|3.9265|0.0201
91596601|NCT00531752|183083516|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0229|STANDARD_ERROR_OF_MEAN|3.8154||0.1931|TWO_SIDED|80.0|0.07753|9.9683|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.9683|0.07753|0.1931
91596602|NCT00531752|183083517|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6766|STANDARD_ERROR_OF_MEAN|0.1759||0.0003|TWO_SIDED|80.0|-0.9046|-0.4487|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.4487|-0.9046|0.0003
91649333|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 12|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
91649334|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.3|-1.0||Month 15|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.3|<0.001
91596603|NCT00531752|183083517|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3075|STANDARD_ERROR_OF_MEAN|0.1871||0.1055|TWO_SIDED|80.0|-0.5499|-0.065|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0650|-0.5499|0.1055
91596604|NCT00531752|183083517|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4684|STANDARD_ERROR_OF_MEAN|0.1791||0.0119|TWO_SIDED|80.0|-0.7012|-0.2356|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2356|-0.7012|0.0119
91596605|NCT00531752|183083517|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1263|STANDARD_ERROR_OF_MEAN|0.1866||0.5016|TWO_SIDED|80.0|-0.3687|0.11608|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.11608|-0.3687|0.5016
91596606|NCT00531752|183083517|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3451|STANDARD_ERROR_OF_MEAN|0.1738||0.0531|TWO_SIDED|80.0|-0.5711|-0.1191|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1191|-0.5711|0.0531
91709326|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.211|TWO_SIDED|95.0|-0.13|0.6|||Repeated measure model|||Baseline serum periostin \>= median||0.60|-0.13|0.211
91596607|NCT00531752|183083517|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4137|STANDARD_ERROR_OF_MEAN|0.1856||0.0306|TWO_SIDED|80.0|-0.6549|-0.1725|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1725|-0.6549|0.0306
91596608|NCT00531752|183083518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7671|STANDARD_ERROR_OF_MEAN|0.1731|<|0.0001|TWO_SIDED|80.0|0.5426|0.99157|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.99157|0.54260|<0.0001
91596609|NCT00531752|183083518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5285|STANDARD_ERROR_OF_MEAN|0.1847||0.0059|TWO_SIDED|80.0|0.28911|0.76798|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.76798|0.28911|0.0059
91596610|NCT00531752|183083518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1526|STANDARD_ERROR_OF_MEAN|0.1431||0.2921|TWO_SIDED|80.0|-0.0336|0.33878|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.33878|-0.0336|0.2921
91596611|NCT00531752|183083518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.198|STANDARD_ERROR_OF_MEAN|0.1498||0.1929|TWO_SIDED|80.0|0.00319|0.39272|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.39272|0.00319|0.1929
91596612|NCT00531752|183083518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3433|STANDARD_ERROR_OF_MEAN|0.1565||0.0332|TWO_SIDED|80.0|0.13988|0.54663|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.54663|0.13988|0.0332
91596613|NCT00531752|183083518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4184|STANDARD_ERROR_OF_MEAN|0.1681||0.0162|TWO_SIDED|80.0|0.20006|0.63674|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.63674|0.20006|0.0162
91596614|NCT00531752|183083519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5103|STANDARD_ERROR_OF_MEAN|0.1103|<|0.0001|TWO_SIDED|80.0|0.36707|0.65345|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.65345|0.36707|<0.0001
91596615|NCT00531752|183083519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3643|STANDARD_ERROR_OF_MEAN|0.1174||0.0031|TWO_SIDED|80.0|0.21189|0.51664|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.51664|0.21189|0.0031
91596616|NCT00531752|183083519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.09408||0.1553|TWO_SIDED|80.0|0.01366|0.25882|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.25882|0.01366|0.1553
91596617|NCT00531752|183083519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.107|STANDARD_ERROR_OF_MEAN|0.09797||0.2809|TWO_SIDED|80.0|-0.0205|0.23458|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.23458|-0.0205|0.2809
91596618|NCT00531752|183083519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2195|STANDARD_ERROR_OF_MEAN|0.1146||0.0603|TWO_SIDED|80.0|0.07101|0.36803|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.36803|0.07101|0.0603
91596619|NCT00531752|183083519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4278|STANDARD_ERROR_OF_MEAN|0.1212||0.0008|TWO_SIDED|80.0|0.27079|0.58479|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.58479|0.27079|0.0008
91596620|NCT00531752|183083520|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.3264|STANDARD_ERROR_OF_MEAN|2.6944|<|0.0001|TWO_SIDED|80.0|-16.83|-9.828|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-9.828|-16.83|<0.0001
91596621|NCT00531752|183083520|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.126|STANDARD_ERROR_OF_MEAN|2.8841||0.0068|TWO_SIDED|80.0|-11.87|-4.382|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-4.382|-11.87|0.0068
91596622|NCT00531752|183083520|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5341|STANDARD_ERROR_OF_MEAN|2.3172||0.1346|TWO_SIDED|80.0|-6.551|-0.5175|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5175|-6.551|0.1346
91596623|NCT00531752|183083520|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0911|STANDARD_ERROR_OF_MEAN|2.4268||0.6552|TWO_SIDED|80.0|-2.067|4.2494|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2494|-2.067|0.6552
91522231|NCT00514683|182919370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.3109||0.8009|TWO_SIDED|95.0|-0.69|0.533|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.533|-0.690|0.8009
91596624|NCT00531752|183083520|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2001|STANDARD_ERROR_OF_MEAN|1.7614||0.0765|TWO_SIDED|80.0|-5.494|-0.9063|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.9063|-5.494|0.0765
91649335|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|95.0|-2.4|-1.0||Month 18|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.4|<0.001
91596625|NCT00531752|183083520|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8781|STANDARD_ERROR_OF_MEAN|1.8976||0.0473|TWO_SIDED|80.0|-6.349|-1.407|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.407|-6.349|0.0473
91596626|NCT02374099|183083567|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.599|TWO_SIDED|95.0|0.54|1.42|||Log Rank||||Hazard ratio and associated two-sided 95% confidence intervals (CI) were estimated by the Cox proportional hazard models.|1.42|0.54|= 0.599
91596627|NCT02374099|183083568|SUPERIORITY||Difference in Response Rates|6.3|||=|0.1479|TWO_SIDED|95.0|-2.47|15.06|||Fisher Exact||||The two-sided 95% confidence interval for the difference in ORR was estimated by the Wilson method.|15.06|-2.47|= 0.1479
91596628|NCT02374099|183083569|SUPERIORITY||Difference in Clinical Benefit Rate|0.7|||=|0.1732|TWO_SIDED|95.0|-17.76|19.04|||Fisher Exact||||The two-sided 95% confidence interval for the difference in clinical benefit rate was estimated by the Wilson method.|19.04|-17.76|= 0.1732
91596629|NCT02374099|183083570|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.2725|TWO_SIDED|95.0|0.23|1.53|||Log Rank||||Hazard Ratio and associated two-sided 95% CI were estimated by the Cox proportional hazard model.|1.53|0.23|= 0.2725
91709327|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.397|TWO_SIDED|95.0|-0.21|0.53|||Repeated measure model|||Baseline serum periostin \>= median||0.53|-0.21|0.397
91522232|NCT00514683|182919370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3159||0.6358|TWO_SIDED|95.0|-0.771|0.472|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.472|-0.771|0.6358
91522233|NCT00514683|182919370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.3252||0.3064|TWO_SIDED|95.0|-0.973|0.307|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.307|-0.973|0.3064
91522234|NCT00514683|182919371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.9646|TWO_SIDED|95.0|0.54|1.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.906|0.540|0.9646
91522235|NCT00514683|182919371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.985|TWO_SIDED|95.0|0.536|1.844|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.844|0.536|0.9850
91649336|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 21|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
91784287|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91784288|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
91522236|NCT00514683|182919371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.7136|TWO_SIDED|95.0|0.604|2.089|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.089|0.604|0.7136
91522237|NCT00514683|182919371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.551||||0.1705|TWO_SIDED|95.0|0.828|2.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.906|0.828|0.1705
91522238|NCT00514683|182919372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.68||0.0479|TWO_SIDED|95.0|-2.69|-0.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.01|-2.69|0.0479
91522239|NCT00514683|182919372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.68||0.0685|TWO_SIDED|95.0|-2.58|0.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||0.09|-2.58|0.0685
91522240|NCT00514683|182919372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.684||0.0099|TWO_SIDED|95.0|-3.12|-0.43|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.43|-3.12|0.0099
91522241|NCT00514683|182919372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.683||0.0152|TWO_SIDED|95.0|-3.01|-0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.32|-3.01|0.0152
91522242|NCT00514683|182919373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|2.253||0.725|TWO_SIDED|95.0|-5.22|3.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.64|-5.22|0.7250
91709328|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.315|TWO_SIDED|95.0|-0.18|0.56|||Repeated Measure Model|||Baseline serum periostin \< median||0.56|-0.18|0.315
91709329|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.26||||0.166|TWO_SIDED|95.0|-0.11|0.63|||Repeated measure model|||Baseline serum periostin \< median||0.63|-0.11|0.166
91784289|NCT04518995|183449136|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
91784290|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.7|-1.2|<0.0001
91784291|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.9|-1.5|<0.0001
91784292|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.4|<0.0001
91784293|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|<0.0001
91784294|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.2|-1.8|<0.0001
91784295|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.3|-1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.6|-2.3|<0.0001
91522243|NCT00514683|182919373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|2.213||0.1389|TWO_SIDED|95.0|-7.63|1.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.07|-7.63|0.1389
91522244|NCT00514683|182919373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|2.221||0.0741|TWO_SIDED|95.0|-8.35|0.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.39|-8.35|0.0741
91522245|NCT00514683|182919373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|STANDARD_ERROR_OF_MEAN|2.262||0.0071|TWO_SIDED|95.0|-10.57|-1.67|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-1.67|-10.57|0.0071
91522246|NCT00514683|182919374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|3.183||0.337|TWO_SIDED|95.0|-9.32|3.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.20|-9.32|0.3370
91522247|NCT00514683|182919374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|3.126||0.1659|TWO_SIDED|95.0|-10.49|1.81|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.81|-10.49|0.1659
91522248|NCT00514683|182919374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.138||0.1897|TWO_SIDED|95.0|-10.29|2.05|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.05|-10.29|0.1897
91522249|NCT00514683|182919374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|3.184||0.0028|TWO_SIDED|95.0|-15.86|-3.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-3.34|-15.86|0.0028
91522250|NCT00514683|182919375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.586||0.8458|TWO_SIDED|95.0|-5.59|4.58|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.58|-5.59|0.8458
91709330|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.262||95.0|-0.13|0.47|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.47|-0.13|0.262
91649337|NCT01294592|183191262|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 24|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
91649338|NCT00623623|183191290|OTHER||Relative risk|0.86||||0.195|TWO_SIDED|95.0|0.68|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.68|0.195
91649339|NCT00623623|183191291|OTHER||Relative risk|1.03||||0.904|TWO_SIDED|95.0|0.68|1.55|||modified Poisson regression|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.55|0.68|0.904
91649340|NCT00623623|183191292|OTHER||Relative risk|0.97||||0.905|TWO_SIDED|95.0|0.6|1.58|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.58|0.60|0.905
91649341|NCT00623623|183191293|SUPERIORITY_OR_OTHER||Relative risk|0.73||||0.12|TWO_SIDED|95.0|0.49|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.49|0.120
91649342|NCT00623623|183191294|OTHER||Relative risk|0.79||||0.17|TWO_SIDED|95.0|0.57|1.11|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.11|0.57|0.170
91649343|NCT00623623|183191295|OTHER||Relative risk|1.1||||0.758|TWO_SIDED|95.0|0.61|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.61|0.758
91596630|NCT01033825|183083601|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-0.5|||>|0.05|TWO_SIDED|95.0|-13.9|13.0|||ANCOVA||Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\<38|Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||13.0|-13.9|>0.05
91596631|NCT01033825|183083601|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-2.4||||0.025|TWO_SIDED|95.0|-15.1|10.2|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||10.2|-15.1|0.025
91596632|NCT01033825|183083601|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL|Mean Difference (Final Values)|10.4|||>|0.05|TWO_SIDED|95.0|-4.7|25.5|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||25.5|-4.7|>0.05
91649344|NCT00623623|183191296|OTHER||Relative risk|1.1||||0.663|TWO_SIDED|95.0|0.73|1.66|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.66|0.73|0.663
91649345|NCT00623623|183191297|OTHER||Relative risk|1.72||||0.148|TWO_SIDED|95.0|0.82|3.6|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||3.60|0.82|0.148
91709331|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.14||||0.379|TWO_SIDED|95.0|-0.17|0.44|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.44|-0.17|0.379
91784296|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
91784297|NCT04518995|183449137|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|<0.0001
91784298|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.3|-0.9|<0.0001
91784299|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.6|-1.3|<0.0001
91784300|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.6|<0.0001
91522251|NCT00514683|182919375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|2.54||0.3286|TWO_SIDED|95.0|-7.48|2.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.51|-7.48|0.3286
91522252|NCT00514683|182919375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.548||0.1799|TWO_SIDED|95.0|-8.43|1.59|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.59|-8.43|0.1799
91784301|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.1|<0.0001
91522253|NCT00514683|182919375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|2.597||0.0948|TWO_SIDED|95.0|-9.46|0.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.76|-9.46|0.0948
91613595|NCT00121810|183121490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.4||||0.039||95.0|-47.7|-1.2||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||-1.2|-47.7|0.039
91784302|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.7|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.0|-1.7|<0.0001
91784303|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.3|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.3|<0.0001
91784304|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
91784305|NCT04518995|183449138|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.6|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.6|<0.0001
91784306|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.06|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.06|<0.0001
91784307|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.22|0.12|<0.0001
91784308|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.33|0.23|<0.0001
91784309|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.32|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.32|<0.0001
91784310|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.01||0.0006|TWO_SIDED|95.0|0.02|0.06||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.06|0.02|0.0006
91784311|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.14|0.06|<0.0001
91784312|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.15|0.23||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.23|0.15|<0.0001
91784313|NCT04518995|183449139|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.24|0.37||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.37|0.24|<0.0001
91784314|NCT04518995|183449140|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|0.3|1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.2|0.3|0.0010
91784315|NCT04518995|183449140|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.6|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.6|<0.0001
91784316|NCT04518995|183449140|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.2|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.2|<0.0001
91784317|NCT04518995|183449140|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
91522254|NCT00514683|182919376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|2.484||0.9708|TWO_SIDED|95.0|-4.98|4.79|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.79|-4.98|0.9708
91522255|NCT00514683|182919376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.44||0.1069|TWO_SIDED|95.0|-8.74|0.85|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.85|-8.74|0.1069
91522256|NCT00514683|182919376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49|STANDARD_ERROR_OF_MEAN|2.453||0.0682|TWO_SIDED|95.0|-9.31|0.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.34|-9.31|0.0682
91522257|NCT00514683|182919376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16|STANDARD_ERROR_OF_MEAN|2.494||0.0043|TWO_SIDED|95.0|-12.06|-2.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-2.26|-12.06|0.0043
91522258|NCT00514683|182919377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.2698|TWO_SIDED|95.0|0.72|3.31|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||3.31|0.72|0.2698
91522259|NCT00514683|182919377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0891|TWO_SIDED|95.0|0.9|4.01|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.01|0.90|0.0891
91522260|NCT00514683|182919377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.0069|TWO_SIDED|95.0|1.29|5.66|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||5.66|1.29|0.0069
91522261|NCT00514683|182919377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0341|TWO_SIDED|95.0|1.05|4.61|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.61|1.05|0.0341
91522262|NCT00514683|182919378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.1015||0.8288|TWO_SIDED|95.0|-0.178|0.222|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.222|-0.178|0.8288
91522263|NCT00514683|182919378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.0974||0.1506|TWO_SIDED|95.0|-0.051|0.332|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.332|-0.051|0.1506
91522264|NCT00514683|182919378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.0977||0.1059|TWO_SIDED|95.0|-0.034|0.351|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.351|-0.034|0.1059
91522265|NCT00514683|182919378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.1008||0.0004|TWO_SIDED|95.0|0.16|0.556|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.556|0.160|0.0004
91522266|NCT00514683|182919379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.068||0.7789|TWO_SIDED|95.0|-0.153|0.115|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.115|-0.153|0.7789
91522267|NCT00514683|182919379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.0652||0.3149|TWO_SIDED|95.0|-0.063|0.194|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.194|-0.063|0.3149
91522268|NCT00514683|182919379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.0654||0.7062|TWO_SIDED|95.0|-0.104|0.153|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.153|-0.104|0.7062
91522269|NCT00514683|182919379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0675||0.0703|TWO_SIDED|95.0|-0.01|0.255|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.255|-0.010|0.0703
91522270|NCT00514683|182919380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.0884||0.4792|TWO_SIDED|95.0|-0.111|0.236|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.236|-0.111|0.4792
91522271|NCT00514683|182919380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.0839||0.2221|TWO_SIDED|95.0|-0.062|0.268|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.268|-0.062|0.2221
91522272|NCT00514683|182919380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.0843||0.151|TWO_SIDED|95.0|-0.044|0.287|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.287|-0.044|0.1510
91522273|NCT00514683|182919380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.0874||0.0001|TWO_SIDED|95.0|0.165|0.509|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.509|0.165|0.0001
91596633|NCT02572752|183083661|SUPERIORITY_OR_OTHER||gMean Ratio|97.478|STANDARD_ERROR_OF_MEAN|11.57|<|0.0001|TWO_SIDED|90.0|94.545|100.502|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.502|94.545|<0.0001
91596634|NCT02572752|183083662|SUPERIORITY_OR_OTHER||gMean Ratio|97.004|STANDARD_ERROR_OF_MEAN|20.77|<|0.0001|TWO_SIDED|90.0|90.948|103.463|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed.||103.463|90.948|<0.0001
91596635|NCT02572752|183083663|SUPERIORITY_OR_OTHER||gMean Ratio|97.149|STANDARD_DEVIATION|11.4|<|0.0001|TWO_SIDED|90.0|94.223|100.166|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.166|94.223|<0.0001
91596636|NCT01464307|183083664|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.777|TWO_SIDED|95.0|-0.1|0.2|||Mixed-Model Repeated Measures|||The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.||0.2|-0.1|0.777
91596637|NCT01464307|183083665|SUPERIORITY_OR_OTHER|||||||0.804||||||worst-case analysis.|Wilcoxon's Rank-Sum Test|||The statistical analysis provided was for all categories of this outcome measure.||||0.804
91596638|NCT01464307|183083666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.845|TWO_SIDED|95.0|0.63|1.74||observed cases analysis.|Regression, Logistic|||Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.||1.74|0.63|0.845
91596639|NCT01464307|183083666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.437|TWO_SIDED|95.0|0.73|2.04||observed cases analysis.|Regression, Logistic|||Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.||2.04|0.73|0.437
91596640|NCT01464307|183083666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.698|TWO_SIDED|95.0|0.59|2.21||observed cases analysis.|Regression, Logistic|||Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.||2.21|0.59|0.698
91596641|NCT00159861|183083676|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.095|||||TWO_SIDED|95.0|0.059|0.132||||||1 Year: Proportion of participants who died.||0.132|0.059|
91596642|NCT00159861|183083676|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.194|||||TWO_SIDED|95.0|0.144|0.243||||||2 Years: Proportion of participants who died.||0.243|0.144|
91596643|NCT00159861|183083676|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.26|||||TWO_SIDED|95.0|0.205|0.315||||||3 Years: Proportion of participants who died.||0.315|0.205|
91596644|NCT00159861|183083676|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.291|||||TWO_SIDED|95.0|0.234|0.348||||||4 Years: Proportion of participants who died.||0.348|0.234|
91784318|NCT04518995|183449141|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.3|0.5|<0.0001
91596645|NCT00159861|183083676|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.369|||||TWO_SIDED|95.0|0.302|0.437||||||5 Years: Proportion of participants who died.||0.437|0.302|
91596646|NCT02701387|183083687|SUPERIORITY_OR_OTHER||||||<|0.01||||||"A 2-factor (implant type x time interval) nonparametric analysis for longitudinal data (Brunner et al. 2002) was used to compare test and control implants across time (baseline + four intervals). The R package nparLD was used (Noguchi et al. 2012)."|nonparametric for longitudinal|||Comparison of ISQ over time. Due to the high number of intervals (T0-T8) relative to the number of observations, data were combined for analysis purposes into 5 comparable intervals as follows: Baseline (T0, unchanged); Tr1=Average of follow-up weeks T1 and T2, Tr2=Average of follow-up weeks T3 and T4; Tr3=Average of follow-up weeks T5 and T6; Tr4=Average of follow-up weeks T7 and T8||||<0.01
91596647|NCT00894556|183083700|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
91596648|NCT00894556|183083701|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
91596649|NCT02116777|183083732|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|4.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is Dose Level 4 (600 mcg/m²/dose +30 mg/m2/dose (BMN 673) BID + 30 mg/m²/dose (TEM), Max 1000 mcg/day). MTD determined by using the Rolling-6 Design.|||||
91596650|NCT00166205|183083784|SUPERIORITY_OR_OTHER||Percent of ITT subjects|69.6||||||95.0|63.8|74.9||||||A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.||74.9|63.8|
91596651|NCT00166205|183083785|SUPERIORITY_OR_OTHER||Mean|75.7|STANDARD_DEVIATION|39.8||||95.0|70.5|80.8||||||||80.8|70.5|
91596652|NCT00166205|183083786|SUPERIORITY_OR_OTHER||Mean|35.7|STANDARD_DEVIATION|6.2||||95.0|34.9|36.5||||||||36.5|34.9|
91596653|NCT00166205|183083787|SUPERIORITY_OR_OTHER||Mean|51.3|STANDARD_DEVIATION|45.8||||95.0|47.6|54.9||||||||54.9|47.6|
91596654|NCT00166205|183083788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4|STANDARD_DEVIATION|10.3||||95.0|9.2|11.7|||||Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)|||11.7|9.2|
91596655|NCT00166205|183083789|SUPERIORITY_OR_OTHER||Mean|5.7|STANDARD_DEVIATION|0.7||||95.0|5.6|5.8||||||||5.8|5.6|
91649346|NCT00623623|183191298|OTHER||Relative risk|0.5||||0.572|TWO_SIDED|95.0|0.05|5.52|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.52|0.05|0.572
91522274|NCT00514683|182919381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.0609||0.1129|TWO_SIDED|95.0|-0.023|0.217|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.217|-0.023|0.1129
91522275|NCT00514683|182919381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.0584||0.1498|TWO_SIDED|95.0|-0.031|0.199|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.199|-0.031|0.1498
91784319|NCT04518995|183449141|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|1.0|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.8|1.0|<0.0001
91784320|NCT04518995|183449141|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.0|1.0|<0.0001
91522276|NCT00514683|182919381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.0585||0.0632|TWO_SIDED|95.0|-0.006|0.224|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.224|-0.006|0.0632
91522277|NCT00514683|182919381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.0604||0.0009|TWO_SIDED|95.0|0.083|0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.320|0.083|0.0009
91522278|NCT00514683|182919382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0676||0.6306|TWO_SIDED|95.0|-0.165|0.1|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.100|-0.165|0.6306
91522279|NCT00514683|182919382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.065||0.7426|TWO_SIDED|95.0|-0.149|0.106|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.106|-0.149|0.7426
91522280|NCT00514683|182919382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0651||0.9209|TWO_SIDED|95.0|-0.134|0.121|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.121|-0.134|0.9209
91522281|NCT00514683|182919382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0671||0.7701|TWO_SIDED|95.0|-0.112|0.152|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.152|-0.112|0.7701
91522282|NCT00514683|182919383|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.6671|TWO_SIDED|95.0|0.36|1.93||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.93|0.36|0.6671
91522283|NCT00514683|182919383|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.5926|TWO_SIDED|95.0|0.34|1.84||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.84|0.34|0.5926
91784321|NCT04518995|183449141|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
91522284|NCT00514683|182919383|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.1381|TWO_SIDED|95.0|0.18|1.27||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.27|0.18|0.1381
91522285|NCT00514683|182919383|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.16||||0.015|TWO_SIDED|95.0|0.03|0.7||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||0.70|0.03|0.0150
91522286|NCT00514683|182919384|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.8282|TWO_SIDED|95.0|0.347|2.336|||Negative binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||2.336|0.347|0.8282
91522287|NCT00514683|182919384|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.5326|TWO_SIDED|95.0|0.278|1.938|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.938|0.278|0.5326
91522288|NCT00514683|182919384|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.1944|TWO_SIDED|95.0|0.167|1.438|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.438|0.167|0.1944
91522289|NCT00514683|182919384|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.0324|TWO_SIDED|95.0|0.056|0.882|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||0.882|0.056|0.0324
91784322|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.5|-1.0|< 0.0001
91649347|NCT00623623|183191299|OTHER||Relative risk|0.81||||0.207|TWO_SIDED|95.0|0.58|1.13|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.13|0.58|0.207
91649348|NCT00623623|183191300|OTHER||Relative risk|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.04|0.63|0.100
91649349|NCT00623623|183191301|OTHER||Relative Risk|0.91||||0.511|TWO_SIDED|95.0|0.67|1.22|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.22|0.67|0.511
91649350|NCT00623623|183191302|OTHER||Relative Risk|1.75||||0.369|TWO_SIDED|95.0|0.52|5.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.97|0.52|0.369
91649351|NCT00623623|183191303|OTHER||Relative Risk|4.99||||0.168|TWO_SIDED|95.0|0.51|49.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||49.08|0.51|0.168
91649352|NCT00623623|183191304|OTHER||Relative Risk|8.02||||0.049|TWO_SIDED|95.0|1.0|63.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||63.97|1.00|0.049
91649353|NCT00623623|183191305|OTHER||Relative Risk|4.51||||0.054|TWO_SIDED|95.0|0.98|20.82|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||20.82|0.98|0.054
91649354|NCT00623623|183191306|OTHER||Relative Risk|2.0||||0.324|TWO_SIDED|95.0|0.5|7.99|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||7.99|0.50|0.324
91649355|NCT00623623|183191307|OTHER||Relative Risk|3.01||||0.032|TWO_SIDED|95.0|1.1|8.24|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||8.24|1.10|0.032
91649356|NCT00623623|183191308|OTHER||Relative Risk|1.36||||0.111|TWO_SIDED|95.0|0.93|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.93|0.111
91784323|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.8|-1.3|< 0.0001
91784324|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-0.8|-1.2|< 0.0001
91784325|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
91649357|NCT00623623|183191309|OTHER||Relative Risk|1.08||||0.397|TWO_SIDED|95.0|0.91|1.28|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.28|0.91|0.397
91649358|NCT00623623|183191310|OTHER||Relative Risk|1.13||||0.107|TWO_SIDED|95.0|0.97|1.31|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.31|0.97|0.107
91649359|NCT00623623|183191311|OTHER||Relative Risk|0.84||||0.471|TWO_SIDED|95.0|0.53|1.34|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.34|0.53|0.471
91649360|NCT00623623|183191312|SUPERIORITY||Relative Risk|0.35||||0.003|TWO_SIDED|95.0|0.17|0.71|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||0.71|0.17|0.003
91784326|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-0.8|-1.3|< 0.0001
91596656|NCT00166205|183083791|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.||||<0.001
91596657|NCT00166205|183083792|SUPERIORITY_OR_OTHER||Mean|56.4|STANDARD_DEVIATION|14.7||||95.0|54.5|58.4||||||||58.4|54.5|
91596658|NCT00166205|183083793|SUPERIORITY_OR_OTHER||Mean|114.5|STANDARD_DEVIATION|32.3||||95.0|110.1|118.8||||||||118.8|110.1|
91596659|NCT00166205|183083794|SUPERIORITY_OR_OTHER||Mean|193.5|STANDARD_DEVIATION|36.9||||95.0|188.6|198.4||||||||198.4|188.6|
91596660|NCT00477165|183083798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.59|TWO_SIDED|95.0|0.687|1.196||p\<0.05 for statistical significance|t-test, 2 sided||Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.|Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups||1.196|0.687|0.59
91596661|NCT01977781|183083802|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Only the statistical analysis results for burning sensation at 10 weeks are reported below as they where the only tolerability results found to be significantly different between the two arms. All other tolerability measures were found to be the same between the two groups.||||0.0019
91596662|NCT01097746|183083829|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.33|TWO_SIDED|95.0|0.58|4.98|||t-test, 2 sided|||Participants for optimal ≤ 1 cm||4.98|0.58|0.33
91649361|NCT00623623|183191313|OTHER||Relative risk|1.17||||0.451|TWO_SIDED|95.0|0.78|1.73|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.73|0.78|0.451
91596663|NCT01097746|183083829|SUPERIORITY||Hazard Ratio (HR)|3.75||||0.04|TWO_SIDED|95.0|1.05|13.34|||t-test, 2 sided|||suboptimal \> 1 cm||13.34|1.05|0.04
91596664|NCT02495844|183083830|SUPERIORITY||Odds Ratio (OR)|4.14|||=|0.0679|TWO_SIDED|95.0|0.9|19.06|||Regression, Logistic|||||19.06|0.90|=0.0679
91596665|NCT00623480|183083855|SUPERIORITY_OR_OTHER||Ratio (On-Demand vs. Prophylaxis)|14.7|||<|0.0001|TWO_SIDED|95.0|8.1|26.5|||Negative Binomial Regression Model|Adjusted for time of follow-up||||26.5|8.1|<0.0001
91596666|NCT00623480|183083856|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.17||||0.6614|TWO_SIDED|95.0|-0.92|0.59|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||0.59|-0.92|0.6614
91596667|NCT00623480|183083857|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.94||||0.0072|TWO_SIDED|95.0|-1.61|-0.26|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||-0.26|-1.61|0.0072
91649362|NCT00623623|183191314|OTHER||Relative Risk|0.87||||0.22|TWO_SIDED|95.0|0.69|1.09|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.09|0.69|0.220
91596668|NCT00623480|183083858|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|13.15|||||TWO_SIDED|95.0|5.23|21.08||no p-values computed|Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||21.08|5.23|
91596669|NCT00960661|183083861|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.|Mean Difference (Final Values)|-0.04||||0.6273|TWO_SIDED|95.0|-0.18|0.11||The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Mixed model repeated measures|||The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.||0.11|-0.18|0.6273
91596670|NCT00847912|183083884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Log Rank|||||||0.93
91596671|NCT00847912|183083885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.93
91596672|NCT02797808|183083936|SUPERIORITY||||||<|0.0083||||||Independent-sample t tests were used to compare the RSFC metrics between groups at baseline and 12 weeks. Bonferroni correction was applied to the alpha level (2-tailed, p\<.05/6= .0083) for multiple testing.|ANOVA|||||||<0.0083
91596673|NCT00535132|183083941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|1.4|<|0.001||||||p-value based on a paired t-test for a within-group comparison.|t-test, 2 sided|||Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.||||<0.001
91596674|NCT00535132|183083942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91596675|NCT00535132|183083943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|||||||<0.001
91596676|NCT00535132|183083944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91649363|NCT02144259|183191349|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE|||Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.||||<0.05
91596677|NCT00535132|183083945|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.002
91596678|NCT00535132|183083946|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.033
91649364|NCT02144259|183191351|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91649365|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.|GMC ratio for anti-1|6.17|||||TWO_SIDED|95.0|5.03|7.58|||ANOVA|||To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||7.58|5.03|
91596679|NCT00535132|183083947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_DEVIATION|13.1|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91596680|NCT00535132|183083948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|0.9|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91596681|NCT00535132|183083949|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|Fisher Exact|||||||0.123
91596682|NCT00535132|183083950|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.125
91596683|NCT00535132|183083951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3|STANDARD_DEVIATION|23.1|<|0.001||||||p-value for within-group comparison based on a paired t-test.|t-test, 2 sided|||||||<0.001
91596684|NCT00535132|183083952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|7.5||0.009|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||0.009
91596685|NCT00535132|183083953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|10.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91596686|NCT00535132|183083954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|4.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91596687|NCT00535132|183083955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|3.0|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
91596688|NCT05051904|183083965|OTHER||Adjusted Hazard Ratio|0.5|||<|0.0001|TWO_SIDED|95.0|0.402|0.622|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.622|0.402|<0.0001
91596689|NCT05051904|183083965|OTHER||Adjusted Hazard Ratio|0.784||||0.0004|TWO_SIDED|95.0|0.686|0.896|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Rivaroxaban.|||0.896|0.686|0.0004
91596690|NCT05051904|183083965|OTHER||Adjusted Hazard Ratio|0.637|||<|0.0001|TWO_SIDED|95.0|0.514|0.791|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.791|0.514|<0.0001
91596691|NCT05051904|183083966|OTHER||Adjusted Hazard Ratio|0.78|||<|0.0001|TWO_SIDED|95.0|0.714|0.851|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.851|0.714|<0.0001
91596692|NCT05051904|183083966|OTHER||Adjusted Hazard Ratio|0.827|||<|0.0001|TWO_SIDED|95.0|0.777|0.88|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio\<1 favors Rivaroxaban|||0.88|0.777|<0.0001
91596693|NCT00143312|183083975|SUPERIORITY_OR_OTHER||Crude IFI Rate (percent) at 12 months|7.0||||||95.0|2.0|19.0||||||||19|2|
91596694|NCT00143312|183083975|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 12 months|10.0||||||95.0|2.0|27.0||||||||27|2|
91596695|NCT00143312|183083976|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 6 months|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
91596696|NCT00143312|183083977|SUPERIORITY_OR_OTHER||IFI Rate (percent) at End of Prophylaxis|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
91522290|NCT00514683|182919385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5206|TWO_SIDED|95.0|0.326|1.765|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.765|0.326|0.5206
91596697|NCT00143312|183083981|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 6 months|79.0||||||95.0|64.0|91.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||91|64|
91596698|NCT00143312|183083981|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 12 months|69.0||||||95.0|52.0|83.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||83|52|
91596699|NCT00563186|183083994|SUPERIORITY_OR_OTHER|This statistical analysis applies to the overall VRE, CDI and MRSA infection and colonization events expressed as incidence density (per 1000 patient-days at risk).|Incidence Rate ratio|1.6|STANDARD_ERROR_OF_MEAN|0.57||0.18|TWO_SIDED|95.0|0.8|3.22|||Poisson||Numerator is novel ward and denominator is traditional ward.|"It was calculated that this study will require 9750 patient days of observation in the traditional design wards and 19,500 patient days of observation in the novel design ward to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units"||3.22|0.80|0.18
91596700|NCT00563186|183083996|SUPERIORITY_OR_OTHER||Rate Ratio|1.929|STANDARD_ERROR_OF_MEAN|0.493||0.175|TWO_SIDED|95.0|0.76|4.9|||Large test for person-time analysis|||||4.9|0.76|0.175
91596701|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.142|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.142|0.087|<0.0001
91596702|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.133|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.133|0.078|<0.0001
91596703|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|0.03|0.085|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.085|0.030|0.0001
91709332|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.25||||0.387|TWO_SIDED|95.0|-0.32|0.81|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.81|-0.32|0.387
91596704|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0139||0.5223|TWO_SIDED|95.0|-0.036|0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.018|-0.036|0.5223
91596705|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|-0.057|STANDARD_ERROR_OF_MEAN|0.0139||0.0001|TWO_SIDED|95.0|-0.084|-0.029|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.029|-0.084|0.0001
91709333|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.303|TWO_SIDED|95.0|-0.26|0.84|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.84|-0.26|0.303
91784327|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.2|-1.7|< 0.0001
91784328|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.0|-1.5|< 0.0001
91784329|NCT04518995|183449142|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
91784330|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.17|0.34||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.34|0.17|< 0.0001
91784331|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.23|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.42|0.23|< 0.0001
91784332|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.27|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.42|0.27|< 0.0001
91784333|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.3|0.48||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.48|0.30|< 0.0001
91784334|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.26|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.42|0.26|< 0.0001
91784335|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.34|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.51|0.34|< 0.0001
91784336|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.29|0.44||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.29|< 0.0001
91784337|NCT04518995|183449143|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.35|0.53||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.53|0.35|< 0.0001
91784338|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.5|-0.9|<0.0001
91784339|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.7|-1.2|<0.0001
91784340|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.6|-1.1|<0.0001
91784341|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.0|-1.4|<0.0001
91784342|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-0.8|-1.2|<0.0001
91784343|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.1|-1.6|<0.0001
91522291|NCT00514683|182919385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.6862|TWO_SIDED|95.0|0.362|1.952|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.952|0.362|0.6862
91522292|NCT00514683|182919385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.517||||0.1891|TWO_SIDED|95.0|0.193|1.384|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.384|0.193|0.1891
91522293|NCT00514683|182919385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.158||||0.0161|TWO_SIDED|95.0|0.035|0.711|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.711|0.035|0.0161
91522294|NCT00514683|182919386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.173||||0.7449|TWO_SIDED|95.0|0.448|3.072|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.072|0.448|0.7449
91522295|NCT00514683|182919386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.316||||0.0925|TWO_SIDED|95.0|0.083|1.209|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.209|0.083|0.0925
91522296|NCT00514683|182919386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0379|TWO_SIDED|95.0|0.04|0.911|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.911|0.040|0.0379
91522297|NCT00514683|182919386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.225||||0.06|TWO_SIDED|95.0|0.048|1.065|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.065|0.048|0.0600
91522298|NCT00514683|182919387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055||||0.7883|TWO_SIDED|95.0|0.713|1.563|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.563|0.713|0.7883
91522299|NCT00514683|182919387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.8293|TWO_SIDED|95.0|0.646|1.419|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.419|0.646|0.8293
91522300|NCT00514683|182919387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.805||||0.303|TWO_SIDED|95.0|0.534|1.216|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.216|0.534|0.3030
91522301|NCT00514683|182919387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.6505|TWO_SIDED|95.0|0.605|1.369|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.369|0.605|0.6505
91522302|NCT00643123|182919406|OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|2.3||0.45|TWO_SIDED||||||t-test, 2 sided|||||||.45
91522303|NCT00530062|182919442|OTHER||Difference in adjusted mean|0.946||||0.5595|TWO_SIDED|95.0|-2.293|4.185||Threshold for significance at 0.05 level.|ANCOVA|||The analysis was performed using the mixed-effect analysis of variance with fixed effects of center, sequence, treatment group and period, and random effect of the participant within sequence.||4.185|-2.293|0.5595
91522304|NCT01376323|182919460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||||||||0.60|-0.13|
91522305|NCT01376323|182919460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.37|0.35||||||||0.35|-0.37|
91522306|NCT01376323|182919460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.49|0.23||||||||0.23|-0.49|
91522307|NCT01376323|182919460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.66|0.06||||||||0.06|-0.66|
91522308|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||||TWO_SIDED|95.0|-1.645|0.543|||||Comparison for glucose.|||0.543|-1.645|
91522309|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.382|||||TWO_SIDED|95.0|-1.472|0.708|||||Comparison for glucose.|||0.708|-1.472|
91522310|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|||||TWO_SIDED|95.0|-1.696|0.516|||||Comparison for glucose.|||0.516|-1.696|
91522311|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595|||||TWO_SIDED|95.0|-1.669|0.48|||||Comparison for glucose.|||0.480|-1.669|
91522312|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.036|||||TWO_SIDED|95.0|-0.042|0.113|||||Comparison for NEFA.|||0.113|-0.042|
91522313|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.073|0.081|||||Comparison for NEFA.|||0.081|-0.073|
91522314|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|||||TWO_SIDED|95.0|-0.058|0.099|||||Comparison for NEFA.|||0.099|-0.058|
91522315|NCT01376323|182919461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|||||TWO_SIDED|95.0|-0.16|-0.007|||||Comparison for NEFA.|||-0.007|-0.160|
91522316|NCT01376323|182919463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.79|0.94||||||||0.94|-0.79|
91522317|NCT01376323|182919463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.9|0.82||||||||0.82|-0.90|
91596706|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.0138||0.0007|TWO_SIDED|95.0|-0.075|-0.02|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.020|-0.075|0.0007
91649366|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.|GMC ratio for anti-4|2.86|||||TWO_SIDED|95.0|2.38|3.45|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||3.45|2.38|
91784344|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-0.8|-1.3|<0.0001
91596707|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|-0.114|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|-0.142|-0.086|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.086|-0.142|<0.0001
91596708|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|-0.084|-0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.028|-0.084|0.0001
91596709|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0141||0.5394|TWO_SIDED|95.0|-0.036|0.019|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.019|-0.036|0.5394
91596710|NCT01136655|183084003|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9863|TWO_SIDED|95.0|-0.027|0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.028|-0.027|0.9863
91596711|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.155|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.155|0.056|<0.0001
91596712|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.0252||0.0092|TWO_SIDED|95.0|0.017|0.116|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.116|0.017|0.0092
91596713|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.0252||0.5509|TWO_SIDED|95.0|-0.035|0.065|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.065|-0.035|0.5509
91596714|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.0249||0.1163|TWO_SIDED|95.0|-0.088|0.01|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.010|-0.088|0.1163
91596715|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|-0.14|-0.041|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.041|-0.140|0.0004
91596716|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.0247||0.04|TWO_SIDED|95.0|-0.1|-0.002|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.002|-0.100|0.0400
91596717|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.0252||0.0011|TWO_SIDED|95.0|-0.133|-0.034|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.034|-0.133|0.0011
91596718|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|-0.068|STANDARD_ERROR_OF_MEAN|0.0254||0.0077|TWO_SIDED|95.0|-0.118|-0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.018|-0.118|0.0077
91596719|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|-0.017|STANDARD_ERROR_OF_MEAN|0.0252||0.4957|TWO_SIDED|95.0|-0.067|0.033|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.033|-0.067|0.4957
91596720|NCT01136655|183084004|SUPERIORITY_OR_OTHER||LS mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.025||0.38|TWO_SIDED|95.0|-0.027|0.071|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.071|-0.027|0.3800
91709334|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.11|-0.84|0.127
91784345|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.7|<0.0001
91784346|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.4|-0.8|<0.0001
91649367|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.|GMC ratio for anti-5|13.47|||||TWO_SIDED|95.0|10.96|16.55|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||16.55|10.96|
91649368|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.|GMC ratio for anti-6B|28.81|||||TWO_SIDED|95.0|22.54|36.81|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||36.81|22.54|
91522318|NCT01376323|182919463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.9|0.85||||||||0.85|-0.90|
91522319|NCT01376323|182919463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.27|0.42||||||||0.42|-1.27|
91522320|NCT01376323|182919464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.27|||||TWO_SIDED|95.0|-48.62|53.16||||||||53.16|-48.62|
91522321|NCT01376323|182919464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67|||||TWO_SIDED|95.0|-58.04|42.7||||||||42.70|-58.04|
91522322|NCT01376323|182919464|SUPERIORITY_OR_OTHER||Median Difference (Net)|24.08|||||TWO_SIDED|95.0|-27.75|75.92||||||||75.92|-27.75|
91522323|NCT01376323|182919464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||||TWO_SIDED|95.0|-52.72|48.53||||||||48.53|-52.72|
91522324|NCT01376323|182919466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58|||||TWO_SIDED|95.0|-19.36|16.2||||||||16.20|-19.36|
91522325|NCT01376323|182919466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||||TWO_SIDED|95.0|-33.0|2.81||||||||2.81|-33.00|
91522326|NCT01376323|182919466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.09|||||TWO_SIDED|95.0|-32.41|4.23||||||||4.23|-32.41|
91522327|NCT01376323|182919466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|||||TWO_SIDED|95.0|-36.55|-1.68||||||||-1.68|-36.55|
91784347|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.7|-1.1|<0.0001
91596721|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.073|0.14|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.140|0.073|<0.0001
91784348|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.5|-0.9|<0.0001
91784349|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.8|-1.3|<0.0001
91784350|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-0.7|-1.1|<0.0001
91784351|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-1.0|-1.5|<0.0001
91784352|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-0.7|-1.2|<0.0001
91784353|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-1.0|-1.5|<0.0001
91784354|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.5|-0.9|< 0.0001
91596722|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|0.078|0.146|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.146|0.078|<0.0001
91596723|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|0.057|STANDARD_ERROR_OF_MEAN|0.0172||0.0011|TWO_SIDED|95.0|0.023|0.09|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.090|0.023|0.0011
91596724|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.0169||0.7589|TWO_SIDED|95.0|-0.028|0.039|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.039|-0.028|0.7589
91596725|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.017||0.0035|TWO_SIDED|95.0|-0.084|-0.017|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.017|-0.084|0.0035
91596726|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|-0.055|STANDARD_ERROR_OF_MEAN|0.0168||0.0011|TWO_SIDED|95.0|-0.089|-0.022|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.022|-0.089|0.0011
91596727|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|-0.115|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|-0.149|-0.081|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.081|-0.149|<0.0001
91596728|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|-0.058|STANDARD_ERROR_OF_MEAN|0.0172||0.0008|TWO_SIDED|95.0|-0.092|-0.024|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.024|-0.092|0.0008
91596729|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|-0.003|STANDARD_ERROR_OF_MEAN|0.0172||0.8582|TWO_SIDED|95.0|-0.037|0.031|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.031|-0.037|0.8582
91596730|NCT01136655|183084005|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6276|TWO_SIDED|95.0|-0.042|0.025|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.025|-0.042|0.6276
91596731|NCT01136655|183084006|SUPERIORITY_OR_OTHER||LS mean difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.393|0.7|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.700|0.393|<0.0001
91596732|NCT01136655|183084006|SUPERIORITY_OR_OTHER||LS mean difference|0.26|||<|0.0001|TWO_SIDED|95.0|0.194|0.347|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.347|0.194|<0.0001
91596733|NCT01136655|183084006|SUPERIORITY_OR_OTHER||LS mean difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.214|0.396|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.396|0.214|<0.0001
91596734|NCT01136655|183084006|SUPERIORITY_OR_OTHER||LS mean difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.371|0.659|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.659|0.371|<0.0001
91596735|NCT01136655|183084006|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.0002|TWO_SIDED|95.0|0.409|0.755|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.755|0.409|0.0002
91596736|NCT01136655|183084006|SUPERIORITY_OR_OTHER||LS mean difference|1.12||||0.4512|TWO_SIDED|95.0|0.827|1.528|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||1.528|0.827|0.4512
91596737|NCT00708123|183084008|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.97||||0.0265|TWO_SIDED|95.0|0.47|7.48||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||7.48|0.47|0.0265
91596738|NCT00708123|183084008|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.66||||0.0017|TWO_SIDED|95.0|2.15|9.18||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors as treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||9.18|2.15|0.0017
91709335|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.42|-0.56|0.775
91522328|NCT04681729|182919468|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9492|TWO_SIDED|95.0|0.41|2.56||Cochran-Mantel-Haenszel test was performed on the association between the ice cube provocation test result and intervention group, stratified by region and background H1-antihistamine regular/daily use (Yes or No). Threshold of significance at 0.01.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the family-wise type-I error. Testing was then performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at two-sided 0.01.||2.56|0.41|0.9492
91522329|NCT02436811|182919485|SUPERIORITY_OR_OTHER||||||<|0.001||||||A stepwise forward selection model was used. All independent variables with P\<0.20 in the univariate analysis were selected and those which were significant (P\<0.05) were kept in the final model. The level of significance was 5%.|Regression, Poisson|||Univariate and multivariate Poisson regressions with robust variance were obtained to estimate the rate ratios (RR) and their respective 95% confidence intervals. Two Poisson regression models were generated, using the knowledge score 15 minutes after the intervention (post-test) and 4 weeks after the interventions (follow-up test) as dependent variables.||||<0.001
91522330|NCT02856113|182919491|SUPERIORITY||Least Square (LS) Mean Difference|0.102|STANDARD_DEVIATION|0.3677|=|0.782|TWO_SIDED|95.0|-0.627|0.831||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|||0.831|-0.627|=0.782
91522331|NCT02856113|182919492|SUPERIORITY||LS Mean Difference|-0.046|STANDARD_DEVIATION|0.2635|=|0.863|TWO_SIDED|95.0|-0.567|0.476||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 12||0.476|-0.567|=0.863
91522332|NCT02856113|182919492|SUPERIORITY||LS Mean Difference|0.004|STANDARD_DEVIATION|0.3123|=|0.99|TWO_SIDED|95.0|-0.614|0.622||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 18||0.622|-0.614|=0.990
91522333|NCT02856113|182919492|SUPERIORITY||LS Mean Difference|-0.412|STANDARD_DEVIATION|0.3664|=|0.264|TWO_SIDED|95.0|-1.139|0.316||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 39||0.316|-1.139|=0.264
91522334|NCT02856113|182919492|SUPERIORITY||LS Mean Difference|-0.483|STANDARD_DEVIATION|0.4165|=|0.25|TWO_SIDED|95.0|-1.314|0.348||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 52||0.348|-1.314|=0.250
91524194|NCT04843930|182923532|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.54|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 261.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.54
91596739|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|-1.69||||0.3413|TWO_SIDED|95.0|-5.19|1.8||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1.80|-5.19|0.3413
91596740|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.26|||<|0.0001|TWO_SIDED|95.0|6.76|13.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||13.76|6.76|<0.0001
91596741|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.19|||<|0.0001|TWO_SIDED|95.0|9.69|16.68||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||16.68|9.69|<0.0001
91596742|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.57|||<|0.0001|TWO_SIDED|95.0|5.09|12.05||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||12.05|5.09|<0.0001
91596743|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.5|||<|0.0001|TWO_SIDED|95.0|8.01|14.98||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||14.98|8.01|<0.0001
91596744|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.59||||0.0104|TWO_SIDED|95.0|-8.1|-1.09||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-1.09|-8.10|0.0104
91596745|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.52|||<|0.0001|TWO_SIDED|95.0|4.04|11.01||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||11.01|4.04|<0.0001
91596746|NCT00708123|183084009|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|2.93||||0.0986|TWO_SIDED|95.0|-0.55|6.41||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||6.41|-0.55|0.0986
91596747|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|196.74||||0.0148|TWO_SIDED|95.0|38.89|354.6||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.||354.60|38.89|0.0148
91596748|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|246.7||||0.0024|TWO_SIDED|95.0|88.3|405.1||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||405.10|88.30|0.0024
91709336|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
91596749|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.96||||0.5328|TWO_SIDED|95.0|-207.62|107.71||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||107.71|-207.62|0.5328
91596750|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-406.19|||<|0.0001|TWO_SIDED|95.0|-564.0|-248.37||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-248.37|-564.00|<0.0001
91596751|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|602.93|||<|0.0001|TWO_SIDED|95.0|445.97|759.9||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||759.90|445.97|<0.0001
91596752|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|652.89|||<|0.0001|TWO_SIDED|95.0|495.05|810.72||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||810.72|495.05|<0.0001
91596753|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|847.55|||<|0.0001|TWO_SIDED|95.0|690.54|1004.55||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1004.55|690.54|<0.0001
91596754|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|897.5|||<|0.0001|TWO_SIDED|95.0|739.92|1055.08||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors treatment, period and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1055.08|739.92|<0.0001
91596755|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|650.8|||<|0.0001|TWO_SIDED|95.0|493.61|808.0||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||808.00|493.61|<0.0001
91596756|NCT00708123|183084010|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|244.62||||0.0024|TWO_SIDED|95.0|87.62|401.61||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||401.61|87.62|0.0024
91596757|NCT02970292|183084011|SUPERIORITY||Difference in MMRM LSMs|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.094|TWO_SIDED|95.0|-4.5|0.4|||mixed-effects model for repeated measure|||||0.4|-4.5|0.0940
91596758|NCT01883635|183084059|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.14
91596759|NCT01883635|183084060|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.65
91596760|NCT01883635|183084061|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.51
91596761|NCT04294901|183084086|SUPERIORITY||Odds Ratio (OR)|1.21||||0.008|TWO_SIDED|95.0|1.05|1.38|||Mixed Models Analysis|Binary mixed effect model with patients nested in providers nested in facilities||It is pre-specified in the Study Protocol and Statistical Analysis Plan to assess all medication groups combined within the Intervention and Control Arms/Groups.||1.38|1.05|0.008
91596762|NCT01733628|183084088|OTHER|Type of statistical Test: Inequality|Hazard Ratio (HR)|0.94||||0.8166|TWO_SIDED|95.0|0.56|1.59|||Wilcoxon (Mann-Whitney)|||||1.59|0.56|0.8166
91596763|NCT02909985|183084106|SUPERIORITY||F|23.68|||<|0.0001|TWO_SIDED||||||ANOVA|(9, 129)||||||<0.0001
91596764|NCT02909985|183084106|SUPERIORITY||F|9.4394|||<|0.0001|TWO_SIDED||||||ANOVA|(11, 52)||||||<0.0001
91596765|NCT01908101|183084116|OTHER|comparison analysis|Median Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.6|4.6||comparison analysis; no P value|||The estimated value is 3.5 months, not years.|Progression free survival (PFS). We hypothesize that metronomic dosing of eribulin will result in a PFS of 4-6 months.||4.6|2.6|
91596766|NCT00590590|183084150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||||||||||Ha: Drug 1 \< Drug 2||||
91596767|NCT00590590|183084150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
91596768|NCT00590590|183084150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 2 \< Placebo||||
91596769|NCT00590590|183084151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||||||||||||Ha: Drug 1 \< Drug 2||||
91596770|NCT00590590|183084151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
91596771|NCT00590590|183084151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||||||||||||Ha: Drug 2 \< Placebo||||
91596772|NCT00590590|183084152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||||||||||||Ha: Drug 1 \< Drug 2||||
91596773|NCT00590590|183084152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||||||||||||Ha: Drug 1 \< Placebo||||
91596774|NCT00590590|183084152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8||||||||||||||Ha: Drug 2 \< Placebo||||
91596775|NCT00590590|183084153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3||||||||||||||Ha: Drug 1 \< Drug 2||||
91596776|NCT00590590|183084153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0||||||||||||||Ha: Drug 1 \< Placebo||||
91596777|NCT00590590|183084153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||||||||||||Ha: Drug 2 \< Placebo||||
91596778|NCT00590590|183084154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||||||||||||Ha: Drug 1 \< Drug 2||||
91596779|NCT00590590|183084154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||||||||||||Ha: Drug 1 \< Placebo||||
91596780|NCT00590590|183084154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||||||||||||Ha: Drug 2 \< Placebo||||
91596781|NCT00590590|183084155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||||||||||Ha: Drug 1 \< Drug 2||||
91596782|NCT00590590|183084155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||||||||||||Ha: Drug 1 \< Placebo||||
91596783|NCT00590590|183084155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||||||||||||Ha: Drug 2 \< Placebo||||
91596784|NCT03605680|183084160|SUPERIORITY||Least Squares (LS ) Mean Difference|-3.15|||=|0.0193|TWO_SIDED|95.0|-5.79|-0.51|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.51|-5.79|=0.0193
91596785|NCT03605680|183084160|SUPERIORITY||LS Mean Difference|-2.74|||=|0.0392|TWO_SIDED|95.0|-5.35|-0.14|||MMRM|||||-0.14|-5.35|=0.0392
91596786|NCT03605680|183084161|SUPERIORITY||LS Mean Difference|-0.27|||=|0.0232|TWO_SIDED|95.0|-0.5|-0.04|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.04|-0.50|=0.0232
91596787|NCT03605680|183084161|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0162|TWO_SIDED|95.0|-0.51|-0.05|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.05|-0.51|=0.0162
91596788|NCT01877187|183084201|OTHER|||||||0.06||||||Statistical significance defined as p \<= .05. Result is for Day 30 timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.06
91596789|NCT01877187|183084201|OTHER|||||||0.09||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.09
91596790|NCT01877187|183084201|OTHER|||||||0.034||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.034
91596791|NCT01877187|183084203|OTHER|||||||0.19||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.19
91596792|NCT01877187|183084203|OTHER|||||||0.011||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.011
91596793|NCT01877187|183084203|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
91596794|NCT01877187|183084205|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
91596795|NCT01877187|183084205|OTHER|||||||0.017||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.017
91709337|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
91596796|NCT01877187|183084205|OTHER|||||||0.08||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.08
91596797|NCT01877187|183084207|OTHER|||||||0.02||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.020
91709338|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.102|TWO_SIDED|95.0|-0.06|0.69|||Repeated measure model|||Th2 high||0.69|-0.06|0.102
91596798|NCT01877187|183084207|OTHER|||||||0.029||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.029
91596799|NCT01877187|183084207|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
91596800|NCT01877187|183084209|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
91596801|NCT01877187|183084209|OTHER|||||||0.013||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.013
91596802|NCT01877187|183084209|OTHER|||||||0.67||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.67
91596803|NCT00517595|183084224|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.02
91596804|NCT00517595|183084225|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.0041
91596805|NCT05525533|183084226|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-1.87|2.24|||Regression, Linear|||||2.24|-1.87|
91596806|NCT05525533|183084226|SUPERIORITY||Mean Difference (Final Values)|1.55|||||TWO_SIDED|95.0|-0.73|3.82|||Regression, Linear|||||3.82|-0.73|
91596807|NCT05525533|183084228|SUPERIORITY||Mean Difference (Final Values)|7.58|||||TWO_SIDED|95.0|-2.92|18.0|||Regression, Linear|||||18|-2.92|
91596808|NCT05525533|183084228|SUPERIORITY||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|0.64|31.0|||Regression, Linear|||||31|0.64|
91596809|NCT05525533|183084230|SUPERIORITY||Mean Difference (Final Values)|47.0|||||TWO_SIDED|95.0|-18.0|113.0|||Regression, Linear|||||113|-18|
91596810|NCT05525533|183084230|SUPERIORITY||Mean Difference (Final Values)|113.0|||||TWO_SIDED|95.0|38.0|189.0|||Regression, Linear|||||189|38|
91596811|NCT05525533|183084231|SUPERIORITY||Mean Difference (Final Values)|3.63|||||TWO_SIDED|95.0|-1.37|8.63|||Regression, Linear|||||8.63|-1.37|
91596812|NCT05525533|183084231|SUPERIORITY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-1.5|4.5|||Regression, Linear|||||4.50|-1.50|
91596813|NCT05525533|183084232|SUPERIORITY||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-0.36|7.3|||Regression, Linear|||||7.30|-0.36|
91596814|NCT05525533|183084232|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|-0.54|7.3|||Regression, Linear|||||7.30|-0.54|
91596815|NCT05525533|183084233|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-3.38|3.72|||Regression, Linear|||||3.72|-3.38|
91596816|NCT05525533|183084233|SUPERIORITY||Mean Difference (Final Values)|7.57|||||TWO_SIDED|95.0|0.42|15.0|||Regression, Linear|||||15|0.42|
91596817|NCT05525533|183084234|SUPERIORITY||Mean Difference (Final Values)|2.46|||||TWO_SIDED|95.0|-0.11|5.02|||Regression, Linear|||||5.02|-0.11|
91596818|NCT05525533|183084234|SUPERIORITY||Mean Difference (Final Values)|3.29|||||TWO_SIDED|95.0|0.33|6.25|||Regression, Linear|||||6.25|0.33|
91596819|NCT02915523|183084235|OTHER||Hazard Ratio (HR)|0.899|||||TWO_SIDED|95.0|0.581|1.393|||||Stratified HR estimated from a stratified univeriate Cox proportional hazards model. Avelumab + placebo was the reference treatment group.|||1.393|0.581|
91596820|NCT00708500|183084253|SUPERIORITY_OR_OTHER||Treatment Difference|37.4|||<|0.0001||95.0|25.7|49.1|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||49.1|25.7|<0.0001
91596821|NCT00708500|183084253|SUPERIORITY_OR_OTHER||Treatment Difference|45.2|||<|0.0001||95.0|33.7|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.7|<0.0001
91596822|NCT00708500|183084254|SUPERIORITY_OR_OTHER||Treatment Difference|39.1|||<|0.0001||95.0|27.2|51.0|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||51.0|27.2|<0.0001
91596823|NCT00708500|183084254|SUPERIORITY_OR_OTHER||Treatment Difference|45.1|||<|0.0001||95.0|33.4|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.4|<0.0001
91596824|NCT00382993|183084272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.63|||<|0.001||95.0|2.76|11.49|||ANOVA|||||11.49|2.76|<0.001
91596825|NCT00794677|183084291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.252|STANDARD_ERROR_OF_MEAN|0.112||0.03||95.0|||||ANOVA|||Statistical significance was determined for a standard two-period crossover design using JMP software (Version 5.0, SAS Institute. Cary, NC).||||0.03
91596826|NCT00794677|183084292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.102||0.01||95.0|||||ANOVA|||||||0.01
91596827|NCT00794677|183084293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.089||0.6||95.0|||||ANOVA|||||||0.60
91596828|NCT00794677|183084294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.47||0.67||95.0|||||ANOVA|||||||0.67
91596829|NCT00794677|183084295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.3||95.0|||||ANOVA|||||||0.30
91596830|NCT00794677|183084296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.412|STANDARD_ERROR_OF_MEAN|1.569|<|0.0001|TWO_SIDED|95.0|||||ANOVA|||||||<0.0001
91596831|NCT00794677|183084297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.846|STANDARD_ERROR_OF_MEAN|2.866|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
91596832|NCT00794677|183084298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.397|STANDARD_ERROR_OF_MEAN|1.893||0.009|TWO_SIDED|95.0|||||ANOVA|||||||0.009
91596833|NCT00794677|183084299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.353|STANDARD_ERROR_OF_MEAN|2.22|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
91596834|NCT05284760|183084303|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Geometric Mean Ratio (GMR)|97.28|||||TWO_SIDED|90.0|87.66|107.96||||||||107.96|87.66|
91596835|NCT05284760|183084303|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|81.04|||||TWO_SIDED|90.0|73.06|89.89||||||||89.89|73.06|
91596836|NCT05284760|183084303|OTHER||GMR|37.48|||||TWO_SIDED|90.0|31.1|45.17||||||||45.17|31.10|
91596837|NCT05284760|183084303|OTHER||GMR|89.45|||||TWO_SIDED|90.0|74.24|107.79||||||||107.79|74.24|
91596838|NCT05284760|183084304|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|97.52|||||TWO_SIDED|90.0|92.17|103.17||||||||103.17|92.17|
91596839|NCT05284760|183084304|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.88|||||TWO_SIDED|90.0|82.14|91.89||||||||91.89|82.14|
91596840|NCT05284760|183084304|OTHER||GMR|87.63|||||TWO_SIDED|90.0|75.92|101.15||||||||101.15|75.92|
91596841|NCT05284760|183084304|OTHER||GMR|95.49|||||TWO_SIDED|90.0|82.73|110.22||||||||110.22|82.73|
91596842|NCT05284760|183084305|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|99.25|||||TWO_SIDED|90.0|92.84|106.1||||||||106.10|92.84|
91596843|NCT05284760|183084305|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.98|||||TWO_SIDED|90.0|81.33|93.03||||||||93.03|81.33|
91596844|NCT05284760|183084305|OTHER||GMR|89.28|||||TWO_SIDED|90.0|78.92|100.99||||||||100.99|78.92|
91596845|NCT05284760|183084305|OTHER||GMR|92.77|||||TWO_SIDED|90.0|81.77|105.25||||||||105.25|81.77|
91596846|NCT00440947|183084339|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA \<50 c/mL at Week 84 was -12% or greater.|Risk Difference (RD)|5.4||||0.14|TWO_SIDED|95.0|-1.8|12.5|||Cochran-Mantel-Haenszel|p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (\<100000/\>=100000)||||12.5|-1.8|0.140
91596847|NCT01827670|183084370|SUPERIORITY_OR_OTHER||Adjusted Mean|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.53|-1.06|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-1.06|-1.53|<0.0001
91596848|NCT01827670|183084371|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-0.62|-1.00|<0.0001
91596849|NCT01827670|183084372|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.4|35.1|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||35.1|19.4|<0.0001
91596850|NCT01827670|183084373|SUPERIORITY_OR_OTHER||Adjusted Mean|7.5||||0.0138|TWO_SIDED|95.0|1.6|13.4|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||13.4|1.6|0.0138
91709339|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.3||||0.116|TWO_SIDED|95.0|-0.08|0.68|||Repeated measure model|||Th2 high||0.68|-0.08|0.116
91709340|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
91596851|NCT01827670|183084374|SUPERIORITY_OR_OTHER||Adjusted Mean|-12.14||||0.0003|TWO_SIDED|95.0|-18.51|-5.77|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-5.77|-18.51|0.0003
91596852|NCT01827670|183084375|SUPERIORITY_OR_OTHER||Adjusted Mean|-21.82|||<|0.0001|TWO_SIDED|95.0|-29.55|-14.09|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments."||-14.09|-29.55|<0.0001
91596853|NCT00606086|183084504|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Mantel-Haenszel test|||||||1.000
91784355|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.6|-1.1|< 0.0001
91596854|NCT02079987|183084513|SUPERIORITY|||||||0.49|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.49
91596855|NCT02079987|183084514|SUPERIORITY|||||||0.23|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.23
91596856|NCT02079987|183084515|SUPERIORITY|||||||0.25||||||A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|difference-in-difference analysis|||||||0.25
91596857|NCT02079987|183084516|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
91784356|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.7|-1.1|< 0.0001
91596858|NCT02079987|183084517|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
91596859|NCT02079987|183084518|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
91596860|NCT02076997|183084521|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91596861|NCT02076997|183084527|OTHER|||||||||||||||||There was no statistical analysis performed for this aim as it was descriptive|There was no statistical analysis performed for this aim as it was descriptive|||
91596862|NCT02076997|183084528|OTHER||Odds Ratio (OR)|6.7|||||TWO_SIDED|95.0||||||||||||
91596863|NCT02533063|183084529|SUPERIORITY|||||||0.217|||||||ANOVA|||||||0.217
91596864|NCT02533063|183084530|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
91596865|NCT02533063|183084531|SUPERIORITY|||||||0.151|||||||ANOVA|||||||0.151
91596866|NCT02533063|183084532|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.450
91596867|NCT02533063|183084533|SUPERIORITY|||||||0.678|||||||ANOVA|||||||0.678
91596868|NCT02533063|183084534|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.060
91596869|NCT02533063|183084537|SUPERIORITY|||||||0.483|||||||ANOVA|||||||0.483
91596870|NCT00652366|183084539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.2026|TWO_SIDED|95.0|0.88|1.8|||Log Rank|||||1.80|0.88|0.2026
91596871|NCT00652366|183084541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6298|TWO_SIDED|95.0|0.77|1.54|||Log Rank|||||1.54|0.77|0.6298
91596872|NCT00652366|183084542|SUPERIORITY_OR_OTHER||Difference in Response Rates|-6.1||||0.2543|TWO_SIDED|95.0|-17.2|5.0|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||5.0|-17.2|0.2543
91596873|NCT00652366|183084542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.19|1.56||||||||1.56|0.19|
91596874|NCT00652366|183084544|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-15.52||||0.0603|TWO_SIDED|95.0|-32.4|1.3|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||1.3|-32.4|0.0603
91596875|NCT00652366|183084546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2678|TWO_SIDED|95.0|0.6|1.15|||Log Rank|||||1.15|0.60|0.2678
91596876|NCT00652366|183084546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8449|TWO_SIDED|95.0|0.74|1.43|||Log Rank|||||1.43|0.74|0.8449
91596877|NCT00652366|183084548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0217|TWO_SIDED|95.0|0.51|0.95|||Log Rank|||||0.95|0.51|0.0217
91596878|NCT00652366|183084548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1596|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1596
91596879|NCT01970501|183084560|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.905|TWO_SIDED|95.0|0.72|1.45|||Log Rank|||||1.45|.72|0.905
91596880|NCT01970501|183084561|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.961|TWO_SIDED|95.0|0.71|1.42|||Log Rank|||||1.42|0.71|0.961
91596881|NCT00677014|183084564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.66||95.0|||||ANOVA|As LVESV values were non normal by Q-Q analysis and Shapiro-Wilk test (p\<.05), a square root transform was used. model adjusted for baseline LVESV.||Gate keeping strategy utilized for Type 1 error control described in design paper - negative results observed for initial comparisons - (each at alpha = .05) between fixed and algorithm optimized AV delay and fixed and Echo optimzied AV. Results from both of these comparisons were non-significant.||||.66
91596882|NCT00350142|183084574|SUPERIORITY_OR_OTHER||proportion|0.75|||||TWO_SIDED|||||||||||||
91596883|NCT01979523|183084724|OTHER|||||||0.74|||||||Log Rank|||||||0.74
91596884|NCT03657368|183084732|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.042|TWO_SIDED|97.5|-0.4|7.3|||Regression, Linear|||||7.3|-0.4|0.042
91596885|NCT03657368|183084732|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|97.5|-3.9|3.7|||Regression, Linear|||||3.7|-3.9|0.966
91596886|NCT03657368|183084733|SUPERIORITY||Odds Ratio (OR)|0.93||||0.519|TWO_SIDED|99.2|0.68|1.27|||Regression, Logistic|||||1.27|0.68|0.519
91596887|NCT03657368|183084733|SUPERIORITY||Odds Ratio (OR)|0.87||||0.232|TWO_SIDED|99.2|0.63|1.19|||Regression, Logistic|||||1.19|0.63|0.232
91596888|NCT03657368|183084734|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.217|TWO_SIDED|99.2|-6.5|2.4|||Regression, Linear|||||2.4|-6.5|0.217
91596889|NCT03657368|183084734|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.66|TWO_SIDED|99.2|-3.7|5.2|||Regression, Linear|||||5.2|-3.7|0.660
91596890|NCT03657368|183084735|SUPERIORITY||mean ratio|1.03||||0.143|TWO_SIDED|99.2|0.97|1.1|||Mixed Models Analysis|||||1.10|0.97|0.143
91596891|NCT03657368|183084735|SUPERIORITY||mean ratio|0.99||||0.649|TWO_SIDED|99.2|0.93|1.05|||Regression, Logistic|||||1.05|0.93|0.649
91596892|NCT01661140|183084759|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority if the difference between treatments is statistically significant and the lower limit of the 95% confidence interval (CI) is greater than 0.9.|Odds Ratio (OR)|1.803||||0.036|TWO_SIDED|95.0|1.037|3.133|||Analysis by logistic regression|||Comparison was Tapering MTX : MTX maintenance. Last post-baseline EULAR response recorded used for participants with a missing result at Week 60.||3.133|1.037|0.036
91596893|NCT00493870|183084801|OTHER|||||||0.05|||||||Log Rank|||||||0.05
91596894|NCT03468309|183084821|SUPERIORITY|T-test was used to compare means at baseline and 12-weeks|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91596895|NCT03468309|183084822|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91596896|NCT03468309|183084823|SUPERIORITY||||||<|0.05|||||||ANOVA|Assumption of sphericity had been violated X2(2)=13.61, p\<.01 so Huynh-Feldt correction was used||||||<0.05
91596897|NCT03468309|183084824|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91596898|NCT01515787|183084826|NON_INFERIORITY|Disease recurrence or death in order to have 85% power to reject the null hypothesis. Noninferiority of the intervention could be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed the 1.29 noninferiority margin.|Hazard Ratio (HR)|0.92||||0.005|TWO_SIDED|90.2|0.74|1.14|||kaplan meier|||||1.14|0.74|0.005
91596899|NCT01515787|183084828|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.74|1.44||||||||1.44|0.74|
91596900|NCT01515787|183084830|SUPERIORITY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.16||||||||3.16|0.44|
91596901|NCT01780831|183084890|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
91596902|NCT01780831|183084890|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|31.0|||||TWO_SIDED|90.0|18.7|46.6||||||||46.6|18.7|
91596903|NCT01780831|183084897|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
91596904|NCT01780831|183084897|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|43.0|||||TWO_SIDED|90.0|28.6|58.1||||||||58.1|28.6|
91596905|NCT01780831|183084898|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
91596906|NCT01780831|183084898|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
91596907|NCT01780831|183084899|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
91596908|NCT01780831|183084899|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
91596909|NCT01780831|183084900|OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
91596910|NCT01780831|183084901|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91596911|NCT01780831|183084902|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
91596912|NCT03015259|183084942|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Referece LS Mean Ratio|1.04|||||TWO_SIDED|90.0|0.958|1.13|||||Fieller's formula was applied|Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.||1.130|0.958|
91596913|NCT03015259|183084943|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Reference LS Mean Ratio|1.004|||||TWO_SIDED|90.0|0.889|1.14|||||Fieller's formula was applied|Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.||1.140|0.889|
91596914|NCT03015259|183084944|OTHER|||||||||||||||||Comparison of means, no formal statistical comparison|no statistical significance applied|||
91596915|NCT03016325|183084984|SUPERIORITY|Part I, clinically relevant hypotension - relative risk|Relative risk from placebo|2.45|||||TWO_SIDED|95.0|0.83|14.53||||||||14.53|0.83|
91596916|NCT03016325|183084984|SUPERIORITY|Part I, clinically relevant hypotension - relative difference|Relative difference from placebo|0.12|||||TWO_SIDED|95.0|-0.02|0.28||||||||0.28|-0.02|
91596917|NCT03016325|183084984|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
91596918|NCT03016325|183084984|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
91596919|NCT03016325|183084984|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
91596920|NCT03016325|183084984|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
91596921|NCT03016325|183084984|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
91596922|NCT03016325|183084984|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
91596923|NCT03016325|183084984|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
91596924|NCT03016325|183084984|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
91596925|NCT03016325|183084984|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
91596926|NCT03016325|183084984|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
91596927|NCT03016325|183084984|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.9|||||TWO_SIDED|95.0|1.04|3.59||||||||3.59|1.04|
91596928|NCT03016325|183084984|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.16|||||TWO_SIDED|95.0|0.01|0.31||||||||0.31|0.01|
91596929|NCT03016325|183084984|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
91709341|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
91522335|NCT03494166|182919503|SUPERIORITY|Key parameter was the coefficient for the trial arm variable in the mixed model, reflecting average difference of group means over time (weeks 1-13).|Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.32||0.31|TWO_SIDED|95.0|-3.9|1.25||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was set at .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of symptom severity index, adjusting for baseline value.|The mean of the group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC (average over time).|"The null hypothesis was that the means in two arms were equal, the alternative hypothesis was that the means were not equal.~We planned to randomize 224 survivors in approximately 3:1 ratio in the first randomization; power was 0.92 to detect the adjusted d=0.54 in the comparison of the SMSH and SMSH+TIPC in the first randomization. The planned number of 224 was exceeded because more survivors than planned were determined to have high need for symptom management."||1.25|-3.90|.31
91522336|NCT03494166|182919504|SUPERIORITY|The key parameter was the coefficient for the variable reflecting trial arm from the second randomization in the mixed model. This parameter reflected average difference between means of two groups over time (weeks 5-13).|Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|3.35||0.52|TWO_SIDED|95.0|-8.91|4.55||The p-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 9 repeated measures of symptom severity index (weeks 5-13), adjusting for baseline value.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The required sample size was 60 per group for .80 power or greater in two-tailed tests at the 0.05 level of significance using the effect size of Cohen's d=0.54 (adjusted for baseline and repeated measures). The actual sample size was smaller (61 total) due to the higher than planned rate of response to the SMSH alone by week 4.||4.55|-8.91|.52
91522337|NCT03494166|182919505|SUPERIORITY|Key parameter was the coefficient for the trial arm from the first randomization variable in the linear regression model.|Median Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.12||0.71|TWO_SIDED|95.0|-2.63|1.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear||The mean of group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.81|-2.63|.71
91596930|NCT03016325|183084984|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
91596931|NCT03016325|183084984|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
91596932|NCT03016325|183084984|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
91784357|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.9|-1.4|< 0.0001
91784358|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.7|-1.1|< 0.0001
91522338|NCT03494166|182919506|SUPERIORITY|The key parameter was the coefficient for the trial arm from the second randomization variable in linear regression model.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|2.91||0.79|TWO_SIDED|95.0|-6.53|5.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|The model included the adjustment for baseline value of the outcome.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||5.01|-6.53|.79
91522339|NCT02110901|182919513|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.254|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||||1.14|0.61|0.254
91522340|NCT02110901|182919514|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.048|TWO_SIDED|95.0|0.43|1.0|||Log Rank|||||1.00|0.43|0.048
91522341|NCT02110901|182919515|SUPERIORITY|||||||0.109|||||||Chi-squared|||||||0.109
91522342|NCT02110901|182919516|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
91522343|NCT00855595|182919521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0903|||||||ANCOVA|||||||0.0903
91522344|NCT01058304|182919546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.1024|TWO_SIDED|95.0|-5.87|0.538|||Mixed Models Analysis|||"The analysis compares study Arm 1 and Arm 2 at 24-week follow-up, with 12-week data also included in the response trajectory.~The hypothesis being tested is that group-based PT (Arm 1) will result in a significantly greater improvement WOMAC scores compared to individual PT (Arm 2)"||0.538|-5.87|0.1024
91522345|NCT01058304|182919546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.444|TWO_SIDED|95.0|-4.64|2.04|||Mixed Models Analysis|||The hypothesis being tested is that the group-based PT program (Arm 1) will result in greater improvements in WOMAC scores at 24-week follow-up (12 weeks after the end of the group program) when compared to usual PT care (Arm 2).||2.04|-4.64|0.444
91522346|NCT01058304|182919547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.527|TWO_SIDED|95.0|-0.463|0.238|||Mixed Models Analysis|||The analysis compares Arms 1 and 2 at 12-week follow-up. The hypothesis being tested is that the group-based PT program (Arm 1) will result in a significantly greater improvement in SPPB scores compared with the individual PT program (Arm 2).||0.238|-0.463|0.527
91522347|NCT02496767|182919549|SUPERIORITY||Least squares mean difference|1.707|STANDARD_ERROR_OF_MEAN|1.9365||0.3782|TWO_SIDED|95.0|-2.089|5.503|||Repeated-measures mixed model|||||5.503|-2.089|0.3782
91522348|NCT02496767|182919549|SUPERIORITY||Least squares mean difference|0.612|STANDARD_ERROR_OF_MEAN|2.0245||0.7625|TWO_SIDED|95.0|-3.359|4.583|||Repeated-measures mixed model|||||4.583|-3.359|0.7625
91522349|NCT02496767|182919549|SUPERIORITY||Least squares mean difference|0.428|STANDARD_ERROR_OF_MEAN|2.1081||0.8394|TWO_SIDED|95.0|-3.711|4.566|||Repeated-measures mixed model|||||4.566|-3.711|0.8394
91522350|NCT02496767|182919550|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.41||0.4521|TWO_SIDED|95.0|-0.5|1.12|||Repeated-measures mixed model|||||1.12|-0.50|0.4521
91522351|NCT02496767|182919550|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.426||0.712|TWO_SIDED|95.0|-1.0|0.68|||Repeated-measures mixed model|||||0.68|-1.00|0.7120
91522352|NCT02496767|182919550|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.439||0.451|TWO_SIDED|95.0|-1.19|0.53|||Repeated-measures mixed model|||||0.53|-1.19|0.4510
91522353|NCT02496767|182919551|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9505|TWO_SIDED|95.0|-0.0374|0.0351|||Repeated-measures mixed model|||||0.0351|-0.0374|0.9505
91522354|NCT02496767|182919551|SUPERIORITY||Mean Difference (Final Values)|0.0066||||0.7336|TWO_SIDED|95.0|-0.0317|0.045|||Repeated-measures mixed model|||||0.0450|-0.0317|0.7336
91522355|NCT02496767|182919551|SUPERIORITY||Mean Difference (Final Values)|0.0088||||0.6593|TWO_SIDED|95.0|-0.0303|0.0479|||Repeated-measures mixed model|||||0.0479|-0.0303|0.6593
91522356|NCT02496767|182919552|SUPERIORITY||Hazard Ratio (HR)|0.818||||0.2369|TWO_SIDED|95.0|0.587|1.141|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.141|0.587|0.2369
91522357|NCT02496767|182919552|SUPERIORITY||Hazard Ratio (HR)|0.988||||0.942|TWO_SIDED|95.0|0.711|1.372|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.372|0.711|0.9420
91522358|NCT02496767|182919552|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.6853|TWO_SIDED|95.0|0.668|1.304|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.304|0.668|0.6853
91522359|NCT02496767|182919553|SUPERIORITY||Hazard Ratio (HR)|1.066||||0.7667|TWO_SIDED|95.0|0.698|1.627|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.627|0.698|0.7667
91522360|NCT02496767|182919553|SUPERIORITY||Hazard Ratio (HR)|0.904||||0.6619|TWO_SIDED|95.0|0.577|1.419|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.419|0.577|0.6619
91522361|NCT02496767|182919553|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.5856|TWO_SIDED|95.0|0.561|1.386|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.386|0.561|0.5856
91784359|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.9|-1.3|< 0.0001
91784360|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.8|-1.2|< 0.0001
91784361|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.9|-1.4|< 0.0001
91784362|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.3|-0.7|< 0.0001
91596933|NCT03016325|183084984|SUPERIORITY|Part II-Japan (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
91596934|NCT03016325|183084984|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
91596935|NCT03016325|183084984|SUPERIORITY|Part II-Japan (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
91596936|NCT03016325|183084984|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
91596937|NCT03016325|183084987|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
91596938|NCT03016325|183084987|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
91596939|NCT03016325|183084987|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
91596940|NCT03016325|183084987|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
91596941|NCT03016325|183084987|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
91596942|NCT03016325|183084987|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
91709342|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.295|TWO_SIDED|95.0|-0.15|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.15|0.295
91596943|NCT03016325|183084988|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
91596944|NCT03016325|183084988|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
91596945|NCT03016325|183084988|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
91596946|NCT03016325|183084988|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
91596947|NCT03016325|183084988|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
91596948|NCT03016325|183084988|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
91596949|NCT03016325|183084988|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
91596950|NCT03016325|183084988|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
91596951|NCT02595723|183085018|OTHER|||||||0.003||||||Overall group difference adjusted for prior group, time, and baseline values.|Mixed Models Analysis|Model includes prior group, time, and baseline values to control for possible effects.||||||0.003
91596952|NCT00513500|183085019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.32||||||95.0|2.19|8.94||||||||8.94|2.19|
91596953|NCT00513500|183085020|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||||95.0|0.14|0.38||||||||0.38|0.14|
91596954|NCT00513500|183085021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.44||||||95.0|0.21|0.93||||||||0.93|0.21|
91596955|NCT01902290|183085054|SUPERIORITY||Difference|-0.05||||0.5219|TWO_SIDED|95.0|-0.203|0.103|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.103|-0.203|0.5219
91596956|NCT01902290|183085055|SUPERIORITY||Rate Ratio|1.41||||0.102|TWO_SIDED|95.0|0.93|2.12|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.12|0.93|0.102
91596957|NCT01902290|183085056|SUPERIORITY||Difference|-0.038||||0.6632|TWO_SIDED|95.0|-0.21|0.134|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification factors, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.134|-0.210|0.6632
91596958|NCT01902290|183085057|SUPERIORITY||Rate Ratio|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.24|0.94|0.096
91709343|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.342|TWO_SIDED|95.0|-0.17|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.17|0.342
91784363|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.4|-0.8|< 0.0001
91784364|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.5|-0.9|< 0.0001
91596959|NCT01902290|183085058|SUPERIORITY||Difference|-0.046||||0.329|TWO_SIDED|95.0|-0.137|0.046|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline score.|Difference = Brodalumab - Placebo|||0.046|-0.137|0.3290
91596960|NCT01902290|183085059|SUPERIORITY||Difference|0.03||||0.4549||95.0|-0.049|0.109|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and FEV1.|Difference = Brodalumab - Placebo|||0.109|-0.049|0.4549
91596961|NCT01902290|183085060|SUPERIORITY||Difference|0.128||||0.6317||95.0|-0.396|0.653|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline value.|Difference = Brodalumab - Placebo|||0.653|-0.396|0.6317
91596962|NCT01902290|183085061|SUPERIORITY||Hazard Ratio (HR)|1.277||||0.238|TWO_SIDED|95.0|0.843|1.936|||Log Rank|Log rank test stratified for baseline stratification factors.||||1.936|0.843|0.238
91596963|NCT01902290|183085062|SUPERIORITY||Odds Ratio (OR)|1.25||||0.351||95.0|0.78|2.01|||Regression, Logistic|Logistic regression adjusted for stratification factors.||||2.01|0.78|0.351
91709344|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.18||||0.406|TWO_SIDED|95.0|-0.24|0.6|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.60|-0.24|0.406
91596964|NCT01902290|183085063|SUPERIORITY||Difference|-0.001||||0.987||95.0|-0.174|0.171|||Mixed-effects model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline AQLQ score.|Difference = Brodalumab - Placebo|||0.171|-0.174|0.9870
91596965|NCT01902290|183085064|SUPERIORITY||Difference|0.635||||0.9053|TWO_SIDED|95.0|-9.82|11.089|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and AM PEFR.|Difference = Brodalumab - Placebo|Analysis of morning peak flow||11.089|-9.820|0.9053
91596966|NCT01902290|183085064|SUPERIORITY||Difference|5.92||||0.2661|TWO_SIDED|95.0|-4.515|16.354|||Mixed-effects model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and PM PEFR.|Difference = Brodalumab - Placebo|Analysis of evening peak flow||16.354|-4.515|0.2661
91596967|NCT01902290|183085065|SUPERIORITY||Difference|-4.021||||0.0871|TWO_SIDED|95.0|-8.627|0.586|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, race group, height and PEFR variation.|Difference = Brodalumab - Placebo|||0.586|-8.627|0.0871
91596968|NCT00385255|183085071|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|1.06|||||TWO_SIDED|95.0|-1.36|3.56||||||Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination.||3.56|-1.36|
91596969|NCT00385255|183085071|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+ Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|-1.67|||||TWO_SIDED|95.0|-2.96|-0.74||||||Difference in seroprotection rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-T antibody, one month post-Boostrix® vaccination.||-0.74|-2.96|
91596970|NCT00385255|183085072|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, being ≥ - 10%.|Difference in percentage|1.4|||||TWO_SIDED|95.0|-0.77|3.68||||||Difference in seropositivity rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.||3.68|-0.77|
91596971|NCT00385255|183085073|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertussis toxoid (PT) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||ANCOVA|||Difference in adjusted GMC ratios for anti-PT antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.||0.82|0.67|
91596972|NCT00385255|183085073|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the filamentous hemagglutinin (FHA) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||ANCOVA|||Difference in adjusted GMC ratio for anti-FHA antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.||0.79|0.64|
91596973|NCT00385255|183085073|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertactin (PRN) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.7|||||TWO_SIDED|95.0|0.6|0.81|||ANCOVA|||Difference in adjusted GMC ratio for anti-PRN antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.||0.81|0.60|
91596974|NCT00385255|183085074|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-1.17|||||TWO_SIDED|95.0|-3.58|1.23||||||Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.23|-3.58|
91709345|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.38||||0.069|TWO_SIDED|95.0|-0.03|0.79|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.79|-0.03|0.069
91596975|NCT00385255|183085074|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.61|||||TWO_SIDED|95.0|-2.22|0.96||||||Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||0.96|-2.22|
91596976|NCT00385255|183085074|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.55|||||TWO_SIDED|95.0|-2.52|1.42||||||Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.42|-2.52|
91596977|NCT00385255|183085075|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H1N1 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.37|||||TWO_SIDED|95.0|-2.84|7.58||||||Difference in seroconversion rates for anti-H1N1 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.||7.58|-2.84|
91596978|NCT00385255|183085075|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H3N2 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|5.58|||||TWO_SIDED|95.0|1.1|10.07||||||Difference in seroconversion rates for anti-H3N2 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.||10.07|1.10|
91596979|NCT00385255|183085075|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase anti-B antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.15|||||TWO_SIDED|95.0|-2.9|7.2||||||Difference in seroconversion rates for anti-B antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.||7.20|-2.90|
91596980|NCT00345176|183085086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||<|0.013|TWO_SIDED|98.7|0.76|1.07||Adjusted for 3 treatment versus placebo comparisons and interim analyses|Regression, Cox|Adjusted for baseline AMD status|The reference group is placebo.|Each of the 3 active arms was compared to the placebo/control arm.||1.07|0.76|<0.013
91596981|NCT00345176|183085086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|||<|0.013|TWO_SIDED|98.7|0.82|1.16||Adjusted for multiple comparisons|Regression, Cox|||||1.16|0.82|<0.013
91596982|NCT00345176|183085086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||<|0.013|TWO_SIDED|98.7|0.75|1.06|||Regression, Cox|Adjusted for multiple comparisons||||1.06|0.75|<0.013
91596983|NCT00345176|183085087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.84|1.08|||Regression, Cox|||||1.08|0.84|<0.05
91596984|NCT00345176|183085087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.09|||Regression, Cox|||||1.09|0.84|<0.05
91596985|NCT00345176|183085087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|<0.05
91596986|NCT00345176|183085088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.05|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Comparison of Lutein/Zeaxantin versus Control for mortality||1.40|0.77|<0.05
91596987|NCT00345176|183085088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.05|TWO_SIDED|95.0|0.84|1.52|||Regression, Cox|||Comparison of DHA/EPA versus Placebo for mortality||1.52|0.84|<0.05
91596988|NCT00345176|183085088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.92|1.65|||Regression, Cox|||Comparison of Lutein/Zeaxanthin + DHA/EPA versus Placebo for Mortality||1.65|0.92|<0.05
91596989|NCT00345176|183085089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.1|||Regression, Cox|||||1.10|0.84|<0.05
91596990|NCT02692495|183085112|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91596991|NCT00391222|183085115|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|95.0||||As defined in the protocol, the olanzapine arm was not included in the primary outcome comparison. Data on the olanzapine arm are presented in outcome measure 7.|Log Rank|||Comparison between risperidone LAI and placebo was performed using a log-rank test controlling for patient type at screening (acute or non-acute) and for geographic region. As recurrence rates at 9 months were assumed to be 45% for risperidone LAI and 68% for placebo, the study would have approximately 90% power to detect a clinically meaningful difference of 23% in recurrence rates of a mood episode if in Period III 100 patients were randomized to each of the 2 relevant treatment arms.||||0.057
91596992|NCT00391222|183085116|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.005
91709346|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.371|TWO_SIDED|95.0|-0.23|0.62|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.62|-0.23|0.371
91596993|NCT00391222|183085116|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
91596994|NCT00391222|183085117|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.655
91596995|NCT00391222|183085117|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.011
91596996|NCT00391222|183085118|SUPERIORITY_OR_OTHER|||||||0.2882|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.2882
91596997|NCT00391222|183085118|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
91709347|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.07||||0.766|TWO_SIDED|95.0|-0.37|0.51|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.51|-0.37|0.766
91709348|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.147|TWO_SIDED|95.0|-0.09|0.57|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.57|-0.09|0.147
91784365|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.7|-1.1|< 0.0001
91596998|NCT00391222|183085119|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
91784366|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-0.9|< 0.0001
91784367|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-1.0|< 0.0001
91522362|NCT02496767|182919554|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.103||0.9991|TWO_SIDED|95.0|-2.17|2.17|||Repeated-measures mixed model|||||2.17|-2.17|0.9991
91522363|NCT02496767|182919554|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.138||0.4808|TWO_SIDED|95.0|-3.04|1.43|||Repeated-measures mixed model|||||1.43|-3.04|0.4808
91522364|NCT02496767|182919554|SUPERIORITY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.165||0.6082|TWO_SIDED|95.0|-2.89|1.69|||Repeated-measures mixed model|||||1.69|-2.89|0.6082
91522365|NCT02496767|182919555|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2602|TWO_SIDED|95.0|0.5|1.206|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.206|0.500|0.2602
91522366|NCT02496767|182919555|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.6748|TWO_SIDED|95.0|0.72|1.662|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.662|0.720|0.6748
91522367|NCT02496767|182919555|SUPERIORITY||Hazard Ratio (HR)|0.938||||0.7694|TWO_SIDED|95.0|0.609|1.443|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.443|0.609|0.7694
91522368|NCT00166296|182919556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.441|TWO_SIDED|95.0|0.075|2.141|||Fisher Exact|||||2.141|0.075|0.441
91522369|NCT00166296|182919557|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
91522370|NCT00166296|182919558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.443||95.0|||||ANOVA|||||||0.443
91522371|NCT00166296|182919559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||ANOVA|||||||0.930
91522372|NCT03477279|182919560|SUPERIORITY||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-5.6|7.3|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||7.3|-5.6|
91522373|NCT03477279|182919561|SUPERIORITY||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-0.8|14.0|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||14.0|-0.8|
91522374|NCT03477279|182919562|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-1.7|21.7|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||21.7|-1.7|
91522375|NCT03477279|182919563|SUPERIORITY||Risk Difference (RD)|16.6|||||TWO_SIDED|95.0|0.9|32.3|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||32.3|0.9|
91522376|NCT03477279|182919564|SUPERIORITY||Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-1.6|31.8||||||||31.8|-1.6|
91522377|NCT03477279|182919565|SUPERIORITY||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-13.2|8.5|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||8.5|-13.2|
91522378|NCT03477279|182919566|SUPERIORITY||Risk Difference (RD)|-4.5|||||TWO_SIDED|95.0|-10.0|10.7|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||10.7|-10.0|
91522379|NCT03477279|182919567|OTHER||Odds Ratio (OR)|4.9|||||TWO_SIDED|95.0|1.7|13.9||||||||13.9|1.7|
91522380|NCT02277990|182919585|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0406|TWO_SIDED|95.12|0.36|0.98||The 0.05 critical value for assessing the primary endpoint was adjusted to 0.0488, to account for a planned interim analysis.|Regression, Cox|The Cox regression was stratified according to device type (pacemaker or CRT-P vs. ICD or CRT-D).||||0.98|0.36|0.0406
91522381|NCT02277990|182919586|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0248|TWO_SIDED|95.12|0.47|0.96|||Regression, Cox|||||0.96|0.47|0.0248
91522382|NCT02277990|182919587|NON_INFERIORITY|The non-inferiority test was performed on the as-treated cohort, per the statistical analysis plan. The non-inferiority margin for the hazard ratio was 1.33 (i.e., the hazard ratio for complications in the envelope group vs. the control group must be significantly lower than 1.33).|Hazard Ratio (HR)|0.93|||<|0.01|TWO_SIDED|95.12|0.77|1.12|||Regression, Cox|||||1.12|0.77|<0.01
91522383|NCT02277990|182919588|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0402|TWO_SIDED|95.12|0.4|0.98|||Regression, Cox|||||0.98|0.40|0.0402
91522384|NCT04581200|182919589|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.61|TWO_SIDED|95.0|-1.63|2.8|||t-test, 2 sided|||||2.80|-1.63|0.61
91522385|NCT04581200|182919590|OTHER|This is an exploratory pilot trial|Mean Difference (Final Values)|0.21||||0.89|TWO_SIDED|95.0|-2.66|3.08|||t-test, 2 sided|||||3.08|-2.66|0.89
91522386|NCT04581200|182919591|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.58|3.3|||t-test, 2 sided|||||3.30|-2.58|0.81
91522387|NCT04581200|182919592|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.75|TWO_SIDED|95.0|-2.98|2.14|||t-test, 2 sided|||||2.14|-2.98|0.75
91522388|NCT04581200|182919593|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.45|TWO_SIDED|95.0|-0.57|0.74|||t-test, 2 sided|||||0.74|-0.57|0.45
91522389|NCT04581200|182919594|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.98|TWO_SIDED|95.0|-0.13|0.13|||t-test, 2 sided|||||0.13|-0.13|0.98
91522390|NCT04581200|182919595|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
91522391|NCT04581200|182919596|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
91522392|NCT04711603|182919599|SUPERIORITY||Placebo difference|-0.97|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.52|-0.42|||MMRM|||||-0.42|-1.52|<0.001
91522393|NCT04672941|182919709|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the CAT score at each visit. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-5.28|||||TWO_SIDED|95.0|-5.67|-4.89|||||Least Square Mean for Visit, change from baseline (3 months - baseline) total CAT Score estimates.|||-4.89|-5.67|
91596999|NCT00391222|183085119|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
91597000|NCT00391222|183085120|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.480
91597001|NCT00391222|183085120|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.001
91597002|NCT01627860|183085125|SUPERIORITY_OR_OTHER||Difference in Seizure free rate|23.57||||0.0759|TWO_SIDED|95.0|-4.21|49.0|||ANOVA||Difference in Seizure free rate (Monotherapy minus Add on therapy)|||49.00|-4.21|0.0759
91597003|NCT01627860|183085126|SUPERIORITY_OR_OTHER||Difference in mean percent change|18.3||||0.7102|TWO_SIDED|95.0|-81.0|117.7|||ANCOVA||Difference in mean percent change of seizure frequency (Monotherapy minus Add on therapy)|||117.7|-81.0|0.7102
91709349|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.35||||0.031|TWO_SIDED|95.0|0.03|0.68|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.68|0.03|0.031
91597004|NCT01225731|183085128|SUPERIORITY_OR_OTHER||% Difference in Response Rate|28.89||||0.001|TWO_SIDED|95.0|13.41|44.36|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||44.36|13.41|0.001
91597005|NCT01225731|183085128|SUPERIORITY_OR_OTHER||% Difference in Response Rate|60.0|||<|0.001|TWO_SIDED|95.0|48.42|71.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||71.58|48.42|<0.001
91597006|NCT01225731|183085128|SUPERIORITY_OR_OTHER||% Difference in Response Rate|61.85|||<|0.001|TWO_SIDED|95.0|50.33|73.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||73.37|50.33|<0.001
91597007|NCT01225731|183085128|SUPERIORITY_OR_OTHER||% Difference in Response Rate|69.97|||<|0.001|TWO_SIDED|95.0|58.96|80.99|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||80.99|58.96|<0.001
91597008|NCT01225731|183085129|SUPERIORITY_OR_OTHER||% Difference in Response Rate|19.37||||0.009|TWO_SIDED|95.0|5.15|33.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||33.58|5.15|0.009
91597009|NCT01225731|183085129|SUPERIORITY_OR_OTHER||% Difference in Response Rate|54.44|||<|0.001|TWO_SIDED|95.0|42.63|66.26|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.26|42.63|<0.001
91709350|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.59||||0.02|TWO_SIDED|95.0|0.1|1.09|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||1.09|0.10|0.020
91709351|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.226|TWO_SIDED|95.0|-0.18|0.77|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.77|-0.18|0.226
91709352|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.01||||0.964|TWO_SIDED|95.0|-0.31|0.33|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.33|-0.31|0.964
91597010|NCT01225731|183085129|SUPERIORITY_OR_OTHER||% Difference in Response Rate|56.23|||<|0.001|TWO_SIDED|95.0|44.43|68.03|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||68.03|44.43|<0.001
91597011|NCT01225731|183085129|SUPERIORITY_OR_OTHER||% Difference in Response Rate|67.65|||<|0.001|TWO_SIDED|95.0|56.42|78.88|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||78.88|56.42|<0.001
91597012|NCT01225731|183085130|SUPERIORITY_OR_OTHER||% Difference in Response Rate|31.11|||<|0.001|TWO_SIDED|95.0|16.22|46.0|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||46.0|16.22|<0.001
91597013|NCT01225731|183085130|SUPERIORITY_OR_OTHER||% Difference in Response Rate|55.56|||<|0.001|TWO_SIDED|95.0|44.48|66.63|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.63|44.48|<0.001
91597014|NCT01225731|183085130|SUPERIORITY_OR_OTHER||% Difference in Response Rate|59.58|||<|0.001|TWO_SIDED|95.0|48.6|70.55|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||70.55|48.60|<0.001
91597015|NCT01225731|183085130|SUPERIORITY_OR_OTHER||% Difference in Response Rate|72.2|||<|0.001|TWO_SIDED|95.0|62.02|82.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||82.37|62.02|<0.001
91597016|NCT00577642|183085141|OTHER|single group|||||<|0.05|||||||t-test, 1 sided|||Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.||||<0.05
91597017|NCT01556425|183085142|SUPERIORITY||Odds Ratio (OR)|2.26||||0.48|TWO_SIDED|95.0|0.2|21.6|||General Estimating Equation (GEE)|||||21.6|0.2|0.48
91597018|NCT01556425|183085142|SUPERIORITY||Odds Ratio (OR)|0.58||||0.61|TWO_SIDED|95.0|0.1|4.6|||General Estimating Equation (GEE)|||||4.6|0.1|0.61
91597019|NCT01556425|183085142|SUPERIORITY||Odds Ratio (OR)|6.0||||0.11|TWO_SIDED|95.0|0.7|54.9|||General Estimating Equation (GEE)|||||54.9|0.7|0.11
91597020|NCT01556425|183085142|SUPERIORITY||Odds Ratio (OR)|2.66||||0.39|TWO_SIDED|95.0|0.3|24.9|||General Estimating Equation (GEE)|||||24.9|0.3|0.39
91597021|NCT01556425|183085142|SUPERIORITY||Odds Ratio (OR)|10.4||||0.03|TWO_SIDED|95.0|1.3|85.5|||General Estimating Equation (GEE)|||||85.5|1.3|0.03
91597022|NCT01556425|183085143|SUPERIORITY||Odds Ratio (OR)|0.36||||0.3|TWO_SIDED|95.0|0.1|2.4|||General Estimating Equation (GEE)|||||2.4|0.1|0.30
91597023|NCT01556425|183085143|SUPERIORITY||Odds Ratio (OR)|0.2||||0.08|TWO_SIDED|95.0|0.03|1.2|||General Estimating Equation (GEE)|||||1.2|0.03|0.08
91597024|NCT01556425|183085143|SUPERIORITY||Odds Ratio (OR)|0.91||||0.91|TWO_SIDED|95.0|0.1|5.8|||General Estimating Equation (GEE)|||||5.8|0.1|0.91
91597025|NCT01556425|183085143|SUPERIORITY||Odds Ratio (OR)|2.47||||0.34|TWO_SIDED|95.0|0.4|15.8|||General Estimating Equation (GEE)|||||15.8|0.4|0.34
91597026|NCT01556425|183085143|SUPERIORITY||Odds Ratio (OR)|4.46||||0.09|TWO_SIDED|95.0|0.8|26.1|||General Estimating Equation (GEE)|||||26.1|0.8|0.09
91597027|NCT01783080|183085144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4||||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
91597028|NCT01783080|183085146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.11|TWO_SIDED||||||Regression, Linear|||||||0.11
91597029|NCT01181011|183085167|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.22|STANDARD_ERROR_OF_MEAN|1.06||0.0107||90.0|99.45|119.95||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||119.95|99.45|0.0107
91597030|NCT01181011|183085168|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.84|STANDARD_ERROR_OF_MEAN|1.06||0.0139|TWO_SIDED|90.0|99.96|120.71||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||120.71|99.96|0.0139
91597031|NCT01181011|183085169|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|97.57|STANDARD_ERROR_OF_MEAN|1.09||0.0126|TWO_SIDED|90.0|84.643|112.472||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.472|84.643|0.0126
91597032|NCT01181011|183085170|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.7|STANDARD_ERROR_OF_MEAN|1.04||0.0011|TWO_SIDED|90.0|102.87|117.07||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||117.07|102.87|0.0011
91597033|NCT01181011|183085171|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|108.8|STANDARD_ERROR_OF_MEAN|1.04||0.0006|TWO_SIDED|95.0|102.1|116.0||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||116.0|102.1|0.0006
91597034|NCT01181011|183085172|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|106.7|STANDARD_ERROR_OF_MEAN|1.03||0|TWO_SIDED|90.0|100.9|112.9||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.9|100.9|0.000
91597035|NCT00401375|183085187|OTHER||Mean Difference (Final Values)|-0.23||||0.4259||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.4259
91597036|NCT00401375|183085187|OTHER||Mean Difference (Final Values)|0.13||||0.3575||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.3575
91597037|NCT00950664|183085191|NON_INFERIORITY_OR_EQUIVALENCE|81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.||||||0.05||95.0|||||Paired-t test|||||||0.05
91597038|NCT03152019|183085198|SUPERIORITY||percentages|0.77|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91597039|NCT04703075|183085208|SUPERIORITY||Risk Difference (RD)|5.5||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
91613596|NCT00121810|183121491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7|||<|0.001||95.0|4.1|13.3||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||13.3|4.1|<0.001
91597040|NCT01187953|183085210|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
91597041|NCT01187953|183085210|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.821|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.821
91597042|NCT01187953|183085210|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.9|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.900
91597043|NCT01187953|183085210|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
91597044|NCT01187953|183085211|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.835|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.835
91597045|NCT01187953|183085211|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.548|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.548
91597046|NCT01187953|183085211|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.822|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.822
91597047|NCT01187953|183085211|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.383|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.383
91597048|NCT03449095|183085212|SUPERIORITY||||||<|0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANOVA|||||||<0.001
91597049|NCT03449095|183085213|SUPERIORITY|||||||0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANCOVA|||||||.001
91597050|NCT03036293|183085221|SUPERIORITY||Mean Difference (Final Values)|1.56||||0.0055|TWO_SIDED|98.33|0.217|2.91|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.91|0.217|0.0055
91597051|NCT03036293|183085221|SUPERIORITY||Mean Difference (Final Values)|2.56|||<|0.0001|TWO_SIDED|98.33|1.1|3.96|||ANCOVA|Baseline score used as covariate. Yeo-Johnson transformation with λ=1,09 was applied. Statistical inference performed for transformed values.|estimate and CL are backtransformed|Mean score differences (begin-end) were compared||3.96|1.1|<0.0001
91597052|NCT03036293|183085221|EQUIVALENCE|equivalence limits were prespecified as \[-2.763; 2.763\]|Mean Difference (Net)|0.89||||0.0008|TWO_SIDED|98.33|-0.64|2.33|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.33|-0.64|0.0008
91597053|NCT03036293|183085222|SUPERIORITY||Mean Difference (Net)|0.6||||0.08|TWO_SIDED|95.0|-0.08|1.54|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.54|-0.08|0.08
91784368|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.6|-1.1|< 0.0001
91784369|NCT04518995|183449144|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.7|-1.2|< 0.0001
91522394|NCT04672941|182919710|OTHER|The logistic generalized estimating equations (GEE) model with CAT response \>= 10 as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|7.186|||<|0.001|TWO_SIDED|95.0|5.745|8.987|||Regression, Logistic||Odds ratio for Visit.|||8.987|5.745|< 0.001
91597054|NCT03036293|183085222|SUPERIORITY||Mean Difference (Net)|0.76||||0.044|TWO_SIDED|95.0|0.02|1.66|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.66|0.02|0.044
91597055|NCT03036293|183085223|SUPERIORITY||Mean Difference (Net)|0.69||||0.21|TWO_SIDED|95.0|-0.4|1.78|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.78|-0.4|0.21
91597056|NCT03036293|183085223|SUPERIORITY||Mean Difference (Net)|1.19||||0.027|TWO_SIDED|95.0|0.14|2.26|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.26|0.14|0.027
91597057|NCT03036293|183085224|SUPERIORITY||Odds Ratio (OR)|1.36||||0.065|TWO_SIDED|95.0|0.98|1.89|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.89|0.98|0.065
91597058|NCT03036293|183085224|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0015|TWO_SIDED|95.0|1.22|2.33|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||2.33|1.22|0.0015
91597059|NCT03036293|183085224|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Week 4 frequencies comparison||||0.7
91597060|NCT03036293|183085224|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 frequencies comparison||||1
91597061|NCT03036293|183085224|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Week 12 frequencies comparison||||0.01
91597062|NCT03036293|183085224|SUPERIORITY|||||||0.57|||||||Fisher Exact|||Week 4 frequencies comparison||||0.57
91597063|NCT03036293|183085224|SUPERIORITY|||||||0.25|||||||Fisher Exact|||Week 8 frequencies comparison||||0.25
91597064|NCT03036293|183085224|SUPERIORITY|||||||0.001|||||||Fisher Exact|||Week 12 frequencies comparison||||0.001
91597065|NCT03036293|183085225|SUPERIORITY||Odds Ratio (OR)|0.88||||0.46|TWO_SIDED|95.0|0.64|1.23|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.23|0.64|0.46
91597066|NCT03036293|183085225|SUPERIORITY||Odds Ratio (OR)|1.27||||0.17|TWO_SIDED|95.0|0.9|1.79|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.79|0.9|0.17
91597067|NCT03036293|183085225|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Week 4 frequencies comparison||||0.38
91597068|NCT03036293|183085225|SUPERIORITY|||||||0.67|||||||Fisher Exact|||Week 8 frequencies comparison||||0.67
91597069|NCT03036293|183085225|SUPERIORITY|||||||0.85|||||||Fisher Exact|||Week 12 frequencies comparison||||0.85
91597070|NCT03036293|183085225|SUPERIORITY|||||||0.71|||||||Fisher Exact|||Week 4 frequencies comparison||||0.71
91597071|NCT03036293|183085225|SUPERIORITY|||||||0.29|||||||Fisher Exact|||Week 8 frequencies comparison||||0.29
91597072|NCT03036293|183085225|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Week 12 frequencies comparison||||0.007
91597073|NCT03036293|183085226|SUPERIORITY||Median Difference (Net)|0.00002||||0.314|TWO_SIDED|95.0|-0.00002|0.33|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||0.33|-0.00002|0.314
91597074|NCT03036293|183085226|SUPERIORITY||Median Difference (Net)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||1|0|0.031
91597075|NCT03036293|183085227|SUPERIORITY||Median Difference (Net)|-0.00001||||0.0021|TWO_SIDED|95.0|-3.0|-0.00001|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00001|-3|0.0021
91597076|NCT03036293|183085227|SUPERIORITY||Median Difference (Net)|-0.00002||||0.0056|TWO_SIDED|95.0|-1.0|-0.00002|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00002|-1|0.0056
91597077|NCT02404103|183085237|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.||||||0.148|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.148
91597078|NCT02404103|183085237|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.74|||||||Mixed Models Analysis|||||||.740
91784370|NCT04518995|183449145|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2489|TWO_SIDED|95.0|-0.2|0.9||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.2|0.2489
91597079|NCT02404103|183085237|EQUIVALENCE|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.921|||||||Mixed Models Analysis|||||||.921
91597080|NCT02404103|183085238|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.||||||0.872|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.872
91597081|NCT02404103|183085238|EQUIVALENCE|secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.82|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.820
91597082|NCT02404103|183085238|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.582|||||||Mixed Models Analysis|||||||0.582
91597083|NCT02404103|183085239|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.782|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.782
91597084|NCT02404103|183085239|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.906|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.906
91597085|NCT02404103|183085239|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.102|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.102
91597086|NCT02404103|183085240|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.62|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.620
91597087|NCT02404103|183085240|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.543|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.543
91784371|NCT04518995|183449145|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1235|TWO_SIDED|95.0|-0.1|1.1||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.1|-0.1|0.1235
91597088|NCT02404103|183085240|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.6|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.6
91597089|NCT01408147|183085241|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||To test the primary hypothesis, a generalized linear mixed effect model was used (intervention group as a fixed effect and clinic and subject as random effects). A group x time interaction term (fixed effect) tested if the change in weight over time differed significantly. The model included participant-level covariates (i.e., ethnicity, weeks postpartum at study entry, lactation, and age).||||<0.0001
91597090|NCT00621504|183085251|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.|Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-0.2|12.6|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.||12.6|-0.2|
91597091|NCT02229552|183085281|OTHER|Repeated measures analysis of variance with zbmi for each year as the repeated dependent measure.|Mean Difference (Final Values)|3.0||||0.051|TWO_SIDED||||||ANOVA|||||||0.051
91597092|NCT00631371|183085297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and Memorial Sloan Kettering Cancer Center \[MSKCC\] risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.8
91597093|NCT00631371|183085298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|1.0|1.4|||Log Rank|||P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.4|1.0|0.9
91597094|NCT00631371|183085299|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.8|1.3|||Cochran-Mantel-Haenszel|||P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.||1.3|0.8|1.0
91597095|NCT00631371|183085300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.6|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.6
91597096|NCT03354663|183085301|OTHER|Single arm trial|Proportion|0.047|||<|0.0001|ONE_SIDED|95.0||0.0864|||Binomial Exact Test|||"The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P \< 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level."||0.0864||<0.0001
91597097|NCT03354663|183085302|OTHER|"The hypothesis is formally expressed as:~H0: P \< 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success."|Proportion|0.98||||0.0001|ONE_SIDED|95.0|0.9495||||Binomial Exact Test||||||0.9495|0.0001
91597098|NCT03354663|183085307|OTHER||Kaplan-Meier Survival Estimate|82.2|||||TWO_SIDED|95.0|74.7|87.6|||||Kaplan-Meier estimate of freedom from recurrence at 1-year|Kaplan Meier Estimate of freedom from recurrence.||87.6|74.7|
91597099|NCT03354663|183085308|OTHER||Kaplan-Meier survival estimate|68.2|||||TWO_SIDED|95.0|59.9|75.1||||||Kaplan-Meier estimate of freedom from recurrence or need for anti-arrhythmic medication||75.1|59.9|
91709353|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.533|TWO_SIDED|95.0|-0.22|0.42|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.42|-0.22|0.533
91597100|NCT03860961|183085335|SUPERIORITY|||||||0.9238||||||Two-sided significance level = 0.05|Chi-squared, Corrected|||Cluster-randomized trial, cluster=practice, maximum 25 patients/practice. Assuming 14 pts/practice, cluster size coefficient of variation of 0.5, intra-cluster correlation (ρ) of 0.04, design effect 1.51, and 59.8% of Arm A patients meeting the criteria provides 80% power for a two-sided α=0.05 two-sample test of proportions to detect a 15% absolute improvement in percentage of patients meeting the criteria with 544 patients (after adjusted for withdrawal and loss to follow-up).||||0.9238
91597101|NCT03860961|183085336|SUPERIORITY|||||||0.5609||||||Two-sided significance level = 0.05|Mixed Models Analysis|Model included baseline CVD risk score, practice as random covariate (participants nested within practice) and treatment arm.||||||0.5609
91597102|NCT00883337|183085348|SUPERIORITY_OR_OTHER|||||||0.5953||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.~Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5953
91709354|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.292|TWO_SIDED|95.0|-0.15|0.5|||Repeated measure model|||2 asthma exacerbations in the past year||0.50|-0.15|0.292
91709355|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.27||||0.097|TWO_SIDED|95.0|-0.05|0.59|||Repeated measure model|||2 asthma exacerbations in the past year||0.59|-0.05|0.097
91597103|NCT00883337|183085348|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5190
91597104|NCT00781456|183085358|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.02|STANDARD_ERROR_OF_MEAN|0.43||0.954|TWO_SIDED|95.0|-0.82|0.87|||Regression, Logistic|Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|||0.87|-0.82|0.954
91597105|NCT00781456|183085359|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.44||0.479|TWO_SIDED|95.0|-0.55|1.17||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.||1.17|-0.55|0.479
91597106|NCT00781456|183085359|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.256|TWO_SIDED|95.0|-0.36|1.37||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment||1.37|-0.36|0.256
91597107|NCT00781456|183085359|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.14|STANDARD_ERROR_OF_MEAN|0.52||0.788|TWO_SIDED|95.0|-1.16|0.88||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.||0.88|-1.16|0.788
91597108|NCT00781456|183085360|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.19||||0.182|TWO_SIDED|95.0|-0.47|0.09|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the 91-day treatment period.||0.09|-0.47|0.182
91597109|NCT00781456|183085360|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.04||||0.853|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the first month of treatment||0.19|-0.71|0.853
91597110|NCT00781456|183085360|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.26||||0.249|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the second month of treatment||0.19|-0.71|0.249
91597111|NCT00781456|183085360|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.4||||0.119|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the third month of treatment||0.10|-0.90|0.119
91597112|NCT00781456|183085361|SUPERIORITY_OR_OTHER|||||||0.457|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the first month of treatment.||||0.457
91597113|NCT00781456|183085361|SUPERIORITY_OR_OTHER|||||||0.361|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the second month of treatment.||||0.361
91597114|NCT00781456|183085361|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the third month of treatment.||||0.018
91597115|NCT00781456|183085361|SUPERIORITY_OR_OTHER|||||||0.709|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.||||0.709
91597116|NCT04852848|183085383|EQUIVALENCE|In our original power calculation, we expected to randomly assign 200 individuals to the Connect2Test (n = 100) and control conditions (n = 100). Power calculations were conducted using G\*Power assuming a two-tailed test with alpha = .05, power = .80, and an estimated COVID-19 testing rate in the Connect2Test condition of 20%. With these assumptions, the minimum detectable effect size (odds ratio) is 2.46, which corresponds to a moderate Cohen's d (0.49).|Odds Ratio (OR)|1.18||||0.6298|TWO_SIDED|95.0|0.61|2.27|||Chi-squared||The control condition was the reference category (Connect2Test intervention = 1, Control = 0).|||2.27|0.61|.6298
91597117|NCT04091087|183085402|SUPERIORITY||Least square (LS) mean difference|-14.36|STANDARD_ERROR_OF_MEAN|7.47||0.0299|TWO_SIDED|90.0|-26.87|-1.86||1-sided|ANOVA|||||-1.86|-26.87|0.0299
91597118|NCT04091087|183085403|SUPERIORITY||Difference in percentage of participants|3.33||||0.1546|TWO_SIDED|90.0|-2.06|8.72||1-sided|Normal approximation test|||||8.72|-2.06|0.1546
91597119|NCT04091087|183085404|SUPERIORITY||Difference in percentage of participants|9.0||||0.0819|TWO_SIDED|90.0|-1.63|19.62||1-sided|Normal approximation test|||Week 1||19.62|-1.63|0.0819
91597120|NCT04091087|183085404|SUPERIORITY||Difference in percentage of participants|-0.47||||0.4789|TWO_SIDED|90.0|-15.2|14.25||1-sided|Normal approximation test|||Week 2||14.25|-15.20|0.4789
91597121|NCT04091087|183085404|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 3||13.03|-13.79|0.4815
91597122|NCT04091087|183085404|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 4||13.03|-13.79|0.4815
91597123|NCT04091087|183085404|SUPERIORITY||Difference in percentage of participants|8.9||||0.1197|TWO_SIDED|90.0|-3.55|21.35||1-sided|Normal approximation test|||Week 5||21.35|-3.55|0.1197
91597124|NCT04091087|183085404|SUPERIORITY||Difference in percentage of participants|18.18||||0.0034|TWO_SIDED|90.0|7.14|29.23||1-sided|Normal approximation test|||Week 6||29.23|7.14|0.0034
91597125|NCT04091087|183085405|SUPERIORITY||Difference in percentage of participants|5.13||||0.2896|TWO_SIDED|90.0|-10.09|20.34||1-sided|Normal approximation test|||||20.34|-10.09|0.2896
91597126|NCT04091087|183085406|SUPERIORITY||Difference in percentage of participants|7.77||||0.2648|TWO_SIDED|90.0|-12.55|28.08||1-sided|Normal approximation test|||Week 1||28.08|-12.55|0.2648
91597127|NCT04091087|183085406|SUPERIORITY||Difference in percentage of participants|17.05||||0.0809|TWO_SIDED|90.0|-2.99|37.08||1-sided|Normal approximation test|||Week 2||37.08|-2.99|0.0809
91597128|NCT04091087|183085406|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 3||21.99|-18.58|0.4450
91597129|NCT04091087|183085406|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 4||21.99|-18.58|0.4450
91649369|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.|GMC ratio for anti-7F|4.75|||||TWO_SIDED|95.0|3.9|5.78|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||5.78|3.9|
91597130|NCT04091087|183085406|SUPERIORITY||Difference in percentage of participants|20.45||||0.0385|TWO_SIDED|90.0|1.43|39.48||1-sided|Normal approximation test|||Week 5||39.48|1.43|0.0385
91597131|NCT04091087|183085406|SUPERIORITY||Difference in percentage of participants|29.64||||0.0045|TWO_SIDED|90.0|10.95|48.33||1 sided|Normal approximation test|||Week 6||48.33|10.95|0.0045
91597132|NCT04091087|183085407|SUPERIORITY||LS mean Difference|3.88|STANDARD_ERROR_OF_MEAN|13.49||0.3874|TWO_SIDED|90.0|-18.67|26.43||1-sided|Normal approximation test|||Week 1||26.43|-18.67|0.3874
91597133|NCT04091087|183085407|SUPERIORITY||LS mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|11.59||0.3506|TWO_SIDED|90.0|-23.85|14.91||1-sided|Normal approximation test|||Week 2||14.91|-23.85|0.3506
91597134|NCT04091087|183085407|SUPERIORITY||LS mean Difference|9.81|STANDARD_ERROR_OF_MEAN|14.23||0.2466|TWO_SIDED|90.0|-13.97|33.6||1-sided|Normal approximation test|||Week 3||33.60|-13.97|0.2466
91597135|NCT04091087|183085407|SUPERIORITY||LS mean Difference|34.74|STANDARD_ERROR_OF_MEAN|15.74||0.0157|TWO_SIDED|90.0|8.43|61.05||1-sided|Normal approximation test|||Week 4||61.05|8.43|0.0157
91597136|NCT04091087|183085407|SUPERIORITY||LS mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|14.55||0.4548|TWO_SIDED|90.0|-25.99|22.68||1-sided|Normal approximation test|||Week 5||22.68|-25.99|0.4548
91597137|NCT04091087|183085407|SUPERIORITY||LS mean Difference|-42.19|STANDARD_ERROR_OF_MEAN|11.99||0.0004|TWO_SIDED|90.0|-62.24|-22.15||1-sided|Normal approximation test|||Week 6||-22.15|-62.24|0.0004
91597138|NCT04091087|183085408|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|9.65||0.2383|TWO_SIDED|90.0|-9.23|23.06||1 sided|ANOVA|||||23.06|-9.23|0.2383
91597139|NCT04091087|183085409|SUPERIORITY||LS mean Difference|-29.95|STANDARD_ERROR_OF_MEAN|21.01||0.0797|TWO_SIDED|90.0|-65.09|5.18||1-sided|Normal approximation test|||Week 1||5.18|-65.09|0.0797
91597140|NCT04091087|183085409|SUPERIORITY||LS mean Difference|-14.39|STANDARD_ERROR_OF_MEAN|18.79||0.2236|TWO_SIDED|90.0|-45.81|17.04||1-sided|Normal approximation test|||Week 2||17.04|-45.81|0.2236
91597141|NCT04091087|183085409|SUPERIORITY||LS mean Difference|-9.94|STANDARD_ERROR_OF_MEAN|15.05||0.2559|TWO_SIDED|90.0|-35.12|15.24||1-sided|Normal approximation test|||Week 3||15.24|-35.12|0.2559
91597142|NCT04091087|183085409|SUPERIORITY||LS mean Difference|-16.01|STANDARD_ERROR_OF_MEAN|22.44||0.2392|TWO_SIDED|90.0|-53.54|21.52||1-sided|Normal approximation test|||Week 4||21.52|-53.54|0.2392
91597143|NCT04091087|183085409|SUPERIORITY||LS mean Difference|-13.01|STANDARD_ERROR_OF_MEAN|19.65||0.2553|TWO_SIDED|90.0|-45.87|19.85||1-sided|Normal approximation test|||Week 5||19.85|-45.87|0.2553
91597144|NCT04091087|183085409|SUPERIORITY||LS mean Difference|-53.01|STANDARD_ERROR_OF_MEAN|30.05||0.0416|TWO_SIDED|90.0|-103.26|-2.75||1-sided|Normal approximation test|||Week 6||-2.75|-103.26|0.0416
91597145|NCT04152161|183085411|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
91709356|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.67|-0.18|0.260
91709357|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.648|TWO_SIDED|95.0|-0.33|0.53|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.53|-0.33|0.648
91522395|NCT04672941|182919711|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was EQ-VAS score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|11.8|||||TWO_SIDED|95.0|11.0|12.6|||||Least Square Mean for Visit, mean change from Baseline (3 months - baseline) of EQ-VAS based on non-responder imputation.|||12.60|11.00|
91597146|NCT04152161|183085411|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
91597147|NCT04152161|183085412|SUPERIORITY||Vaccine Efficacy|-0.009|||||TWO_SIDED|95.0|-0.395|0.27|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.270|-0.395|
91597148|NCT04152161|183085412|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.5224|TWO_SIDED|95.0|0.73|1.395|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.395|0.730|0.5224
91597149|NCT04152161|183085413|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
91597150|NCT04152161|183085413|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
91597151|NCT00983983|183085430|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||Change over time in the ALSFRS-R was analyzed using random-slopes models||||0.07
91597152|NCT00983983|183085432|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||||||0.06
91597153|NCT00983983|183085433|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Fisher Exact|||||||0.0005
91597154|NCT00983983|183085434|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
91597155|NCT02599961|183085436|SUPERIORITY||LS Mean|-82.73|STANDARD_ERROR_OF_MEAN|11.363|<|0.0001|TWO_SIDED|95.0|-105.0|-60.46||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|generalized estimating equation (GEE)|||Month 0-3||-60.46|-105.00|< 0.0001
91597156|NCT02599961|183085436|SUPERIORITY||LS mean|-54.91|STANDARD_ERROR_OF_MEAN|16.097||0.0006|TWO_SIDED|95.0|-86.46|-23.36||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 4-6||-23.36|-86.46|0.0006
91597157|NCT02599961|183085436|SUPERIORITY||LS Mean|-52.53|STANDARD_ERROR_OF_MEAN|16.882||0.0019|TWO_SIDED|95.0|-85.62|-19.45||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 7-9||-19.45|-85.62|0.0019
91597158|NCT02599961|183085436|SUPERIORITY||LS Mean|-82.65|STANDARD_ERROR_OF_MEAN|15.55|<|0.0001|TWO_SIDED|95.0|-113.13|-52.17||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 10-12||-52.17|-113.13|< 0.0001
91597159|NCT01857869|183085452|OTHER||1-Relative Risk|86.7|||<|0.0001|TWO_SIDED|95.0|66.8|94.6||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||94.6|66.8|<0.0001
91597160|NCT01857869|183085452|OTHER||1-Relative Risk|62.5||||0.0009|TWO_SIDED|95.0|29.4|80.1||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||80.1|29.4|0.0009
91597161|NCT03341962|183085488|SUPERIORITY||Odds Ratio (OR)|1.0188||||0.5836|TWO_SIDED||||||Cochran-Mantel-Haenszel|1-sided exact test adjusted for stratification factors (prior use of any biologics and concurrent use of corticosteroids), α=0.097||||||0.5836
91613597|NCT00121810|183121491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.029||95.0|0.7|13.1||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||13.1|0.7|0.029
91597162|NCT01087905|183085544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.076|TWO_SIDED|95.0|0.98|1.61|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT)."||1.61|0.98|.076
91597163|NCT01087905|183085544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT)."||1.75|1.06|.017
91597164|NCT01087905|183085544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.343|TWO_SIDED|95.0|0.69|1.14|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC)."||1.14|0.69|.343
91597165|NCT01087905|183085545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.029|TWO_SIDED|95.0|1.04|2.14|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.14|1.04|.029
91597166|NCT01087905|183085545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.079|TWO_SIDED|95.0|0.96|1.97|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||1.97|0.96|.079
91597167|NCT01087905|183085545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.003|TWO_SIDED|95.0|1.2|2.45|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.45|1.20|.003
91597168|NCT01087905|183085546|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|357.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.||||
91597169|NCT01087905|183085546|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|712.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.||||
91649370|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.|GMC ratio for anti-9V|14.1|||||TWO_SIDED|95.0|11.21|17.75|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||17.75|11.21|
91709358|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.28||||0.398|TWO_SIDED|95.0|-0.37|0.93|||Repeated measure model|||Chronic OCS use||0.93|-0.37|0.398
91784372|NCT04518995|183449145|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9765|TWO_SIDED|95.0|-0.5|0.5||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.5|-0.5|0.9765
91709359|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.32||||0.327|TWO_SIDED|95.0|-0.95|0.32|||Repeated measure model|||Chronic OCS use||0.32|-0.95|0.327
91784373|NCT04518995|183449145|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3559|TWO_SIDED|95.0|-0.3|0.8||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.8|-0.3|0.3559
91649371|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.|GMC ratio for anti-14|22.92|||||TWO_SIDED|95.0|17.51|30.0|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||30|17.51|
91649372|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.|GMC ratio for anti-18C|10.01|||||TWO_SIDED|95.0|7.95|12.61|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||12.61|7.95|
91649373|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.|GMC ratio for anti-19F|9.25|||||TWO_SIDED|95.0|7.29|11.74|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||11.74|7.29|
91649374|NCT00950833|183191365|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.|GMC ratio for anti-23F|36.52|||||TWO_SIDED|95.0|27.59|48.34|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||48.34|27.59|
91649375|NCT01205529|183191411|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED||||||Regression, Logistic||0 participants with rare SCN5A non-synonymous variants met the primary outcome for ST-segment elevation.||Given the very small number of outcomes (N=4) and the small number of participants with the primary determinant (N=2), a Fisher's Exact Test is the appropriate test and it yields a P-value=1.000.|||1.0
91649376|NCT00711867|183191412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as -0.5 C.|Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.14|||t-test, 2 sided|||H0: Mu\_VH - Mu\_BH \<= -0.5 C.||-0.14|-0.55|
91649377|NCT03840135|183191413|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.05|TWO_SIDED|95.0|-0.6|0.16|||t-test, 2 sided|||The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).||0.16|-0.6|<0.05
91649378|NCT03840135|183191414|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
91649379|NCT03840135|183191415|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
91649380|NCT03840135|183191416|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
91649381|NCT03840135|183191417|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91522396|NCT04672941|182919712|OTHER|The logistic generalized estimating equations (GEE) model with mobility as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|3.9|5.14|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.14|3.90|< 0.001
91597170|NCT01087905|183085546|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|1290.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.||||
91597171|NCT00790907|183085547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.267|TWO_SIDED|95.0|0.54|1.19|||Regression, Logistic|||||1.19|0.54|0.267
91597172|NCT00774345|183085555|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.276|TWO_SIDED|95.0|0.61|1.15||The p-value is based on a stratified log-rank test.|Log Rank||Based on the stratified cox proportional hazards model comparing the hazard functions associated with the treatment groups.|||1.15|0.61|0.276
91597173|NCT01119248|183085572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.62|<|0.001|TWO_SIDED|95.0|-0.48|-0.25|||t-test, 2 sided|||||-0.25|-0.48|<.001
91597174|NCT01119248|183085573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0001|TWO_SIDED|95.0|-0.95|-0.43|||t-test, 2 sided|||pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRI||-0.43|-0.95|0.0001
91597175|NCT01119248|183085574|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91597176|NCT00853671|183085583|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||||||<0.0001
91597177|NCT00853671|183085585|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||Pearson Correlation||||<0.0001
91597178|NCT01332357|183085630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.56|2.46||The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|||||2.46|1.56|<0.0001
91597179|NCT01332357|183085630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.42|2.25||The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication||||2.25|1.42|<0.0001
91597180|NCT01332357|183085630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008|||<|0.0001|TWO_SIDED|95.0|1.005|1.011||The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction|Regression, Cox|Evaluates the impact of each day treatment with a controller was delayed||||1.011|1.005|<0.0001
91597181|NCT04099251|183085631|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||Regression, Cox|||||0.59|0.30|< 0.0001
91597182|NCT04311502|183085643|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.21|TWO_SIDED|90.0|0.82|1.79|||Regression, Cox|Adjusted for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).|Arm 1 vs Arm 2|This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.79|0.82|0.21
91597183|NCT04311502|183085644|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.01|TWO_SIDED|90.0|0.14|0.45|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~This outcome measure is limited to data obtained up to September 25, 2023."||0.45|0.14|<0.01
91597184|NCT04311502|183085644|SUPERIORITY||Risk Difference (RD)|0.28|||<|0.01|TWO_SIDED|90.0|0.11|0.44|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~All data through week 65."||0.44|0.11|<0.01
91597185|NCT04311502|183085645|SUPERIORITY||Risk Difference (RD)|-0.26||||0.01|TWO_SIDED|95.0|-0.47|-0.06|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.06|-0.47|0.01
91597186|NCT04311502|183085646|SUPERIORITY||Risk Difference (RD)|-0.25||||0.02|TWO_SIDED|95.0|-0.46|-0.04|||Wald chi-square||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.04|-0.46|0.02
91597187|NCT04311502|183085647|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|-0.06||||0.35|TWO_SIDED|95.0|-0.22|0.05|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.05|-0.22|0.35
91597188|NCT04311502|183085649|SUPERIORITY||GEE|24.04|||<|0.01|TWO_SIDED|95.0|15.13|32.94|||Regression, Linear|||||32.94|15.13|<0.01
91597189|NCT04311502|183085651|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.01|TWO_SIDED|95.0|2.4|21.3|||Regression, Logistic|||Compares the odds of participants having maximum occurrence of QTcF change from baseline of ≥30 ms and \<60 ms, or ≥60 ms between Arm 1 and Arm 2 in the safety set using the proportional odds model.||21.30|2.40|<0.01
91597190|NCT04311502|183085651|SUPERIORITY||Risk Difference (RD)|0.41|||<|0.01|TWO_SIDED|95.0|0.17|0.58|||exact unconditional||Arm 1 - Arm 2|Proportion of Participants with Worst Changes in QTcF from Screening \>= 30 ms over visits at Weeks 2, 8, 13||0.58|0.17|<0.01
91649382|NCT03840135|183191418|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
91649383|NCT03840135|183191419|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
91649384|NCT03840135|183191422|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91649385|NCT03840135|183191423|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91649386|NCT04133519|183191424|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5352|TWO_SIDED|95.0|0.73|1.84||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel|||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender||1.84|0.73|0.5352
91649387|NCT04133519|183191424|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0232|TWO_SIDED|95.0|1.08|2.87|||Cochran-Mantel-Haenszel||Odds ratio reflects the odds of the number of GDH responders being greater than the number of MR responders for abdominal pain intensity.|The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1.||2.87|1.08|0.0232
91597191|NCT04311502|183085652|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.18|TWO_SIDED|90.0|0.84|1.8||One-sided p-value|Regression, Cox|Adjusted for HIV status (positive/negative) and TB disease according to chest X-ray (advanced/not advanced)|Arm 1 vs. Arm 2|||1.80|0.84|0.18
91597192|NCT04311502|183085653|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.25|TWO_SIDED|90.0|0.8|1.71||One-sided p-value|Regression, Cox|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.71|0.80|0.25
91597193|NCT04311502|183085654|SUPERIORITY||Risk Difference (RD)|0.13||||0.23|TWO_SIDED|95.0|-0.07|0.35|||Fisher Exact|||||0.35|-0.07|0.23
91649388|NCT04133519|183191424|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0254|TWO_SIDED|95.0|1.07|2.89||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||Odds ratio reflects the odds of GDH being superior to MR.|"Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a \> 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders.~This analysis was specified in FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance."|Among all subjects, 64.0% reported Adequate Relief and 67.7% reported overall satisfaction with Regulora.|2.89|1.07|0.0254
91649389|NCT04133519|183191425|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.8115|TWO_SIDED|95.0|-0.434|0.554|||ANOVA|||The least square (LS) mean difference between the GDH and MR groups using an analysis of variance (ANOVA) model||0.554|-0.434|0.8115
91649390|NCT04133519|183191426|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.7564|TWO_SIDED|95.0|-0.236|0.325|||ANOVA|||Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH and comparator using an ANOVA model adjusted for gender and IBS subtype. The daily pain frequency measurement was derived from the daily pain intensity measurement. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days in each time period with abdominal pain.||0.325|-0.236|0.7564
91649391|NCT04133519|183191427|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4753|TWO_SIDED|95.0|0.76|1.81||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||GDH:MR Relative Risk|A Stool Consistency Responder is defined as a \>=30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fall within Group 2 (normal stools)||1.81|0.76|0.4753
91597194|NCT04311502|183085655|SUPERIORITY||Risk Difference (RD)|0.05||||0.56|TWO_SIDED|95.0|-0.11|0.24|||Fisher Exact|||||0.24|-0.11|0.56
91597195|NCT04311502|183085656|SUPERIORITY||Risk Difference (RD)|0.07||||0.27|TWO_SIDED|90.0|-0.04|0.18|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing an SAE through week 65 was compared between Arm 1 and Arm 2.||0.18|-0.04|0.27
91649392|NCT04133519|183191428|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.6793|TWO_SIDED|95.0|-0.301|0.46|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-C participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||0.460|-0.301|0.6793
91597196|NCT04311502|183085657|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-0.1|0.13|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.13|-0.10|1
91597197|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.597|TWO_SIDED|95.0|0.57|1.39|||Regression, Cox|||Time point: Screening||1.39|0.57|0.597
91709360|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.105|TWO_SIDED|95.0|-0.05|0.52|||Repeated measure model|||Without chronic OCS use||0.52|-0.05|0.105
91597198|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.58|1.44|||Regression, Cox|||Time point: Entry||1.44|0.58|0.70
91597199|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07|TWO_SIDED|95.0|0.4|1.03|||Regression, Cox|||Time point: Week 2||1.03|0.40|0.07
91597200|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.04|TWO_SIDED|95.0|0.34|0.98|||Regression, Cox|||Time point: Week 4||0.98|0.34|0.04
91597201|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6|TWO_SIDED|95.0|0.41|1.67|||Regression, Cox|||Time point: Week 6||1.67|0.41|0.60
91597202|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.595|TWO_SIDED|95.0|0.33|1.88|||Regression, Cox|||Time point: Week 8||1.88|0.33|0.595
91597203|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.66|TWO_SIDED|95.0|0.25|2.44|||Regression, Cox|||Time point: Week 10||2.44|0.25|0.66
91597204|NCT04311502|183085658|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.86|TWO_SIDED|95.0|0.21|6.39|||Regression, Cox|||Time point: Week 12||6.39|0.21|0.86
91597205|NCT04311502|183085659|SUPERIORITY||Slope|20.43|||<|0.01|TWO_SIDED|95.0|5.71|35.16|||Regression, Linear|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||35.16|5.71|<0.01
91597206|NCT05032157|183085676|SUPERIORITY||Mean Difference (Final Values)|-7.68|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-9.91|-5.46|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|UAS7 at Week 12 (Scenario 1 with UAS7 as primary efficacy endpoint)||-5.46|-9.91|< 0.001
91649393|NCT04133519|183191428|SUPERIORITY||Mean Difference (Final Values)|0.173||||0.9468|TWO_SIDED|95.0|-4.904|5.249|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-D participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||5.249|-4.904|0.9468
91649394|NCT04133519|183191429|SUPERIORITY||Median Difference (Final Values)|-1.602||||0.5015|TWO_SIDED|95.0|-6.282|3.077|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random The unstructured covariance matrix was used to model the within-participant correlation. The model-based least square (LS) means and LS mean differences (GDH minus comparator) and associated 95% CIs for each week and overall were estimated."||3.077|-6.282|0.5015
91784374|NCT04518995|183449146|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.16|0.25||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.25|0.16|<0.0001
91784375|NCT04518995|183449146|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.27|0.39||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.39|0.27|<0.0001
91597207|NCT05032157|183085677|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-4.29|-2.16|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE, biologics, week, baseline score, and both interaction of treatment by week and interaction of baseline score by week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.16|-4.29|<0.001
91649395|NCT04133519|183191430|SUPERIORITY||Mean Difference (Final Values)|4.586||||0.2117|TWO_SIDED|95.0|-2.619|11.79|||Mixed Models Analysis|||"Percent Overall Work Impairment Due to IBS defined as the percent time missed by not showing up for work, plus the percent time missed while working, and calculated as: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]."||11.790|-2.619|0.2117
91790419|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.19||0.751|TWO_SIDED|95.0|-0.434|0.313||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.313|-0.434|0.751
91597208|NCT05032157|183085678|SUPERIORITY||Mean Difference (Final Values)|-4.47|STANDARD_ERROR_OF_MEAN|0.634|<|0.001|TWO_SIDED|95.0|-5.71|-3.23|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-3.23|-5.71|< 0.001
91597209|NCT05032157|183085679|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.39|6.18|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Disease activity control (UAS7 =\< 6) at Week 12||6.18|2.39|< 0.001
91597210|NCT05032157|183085680|SUPERIORITY||Odds Ratio (OR)|5.78|||<|0.001|TWO_SIDED|95.0|2.83|11.78|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Complete absence of hives and itch (UAS7 = 0) at Week 12||11.78|2.83|< 0.001
91597211|NCT05032157|183085681|SUPERIORITY||Odds Ratio (OR)|7.92|||<|0.001|TWO_SIDED|95.0|3.72|16.85|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Early onset of disease activity control (UAS7 =\< 6) at Week 2||16.85|3.72|< 0.001
91597212|NCT05032157|183085682|SUPERIORITY||Odds Ratio (OR)|2.75|||<|0.001|TWO_SIDED|95.0|1.65|4.58|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|Dermatology Life Quality Index (DLQI) = 0-1 at Week 12||4.58|1.65|< 0.001
91597213|NCT05032157|183085683|SUPERIORITY||Rate ratio|3.26|||<|0.001|TWO_SIDED|95.0|2.26|4.71|||Regression, Linear||Negative binomial regression with log link includes treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics as covariates. A rate ratio \>1 favors LOU064 25 mg b.i.d.|Disease activity control (UAS7 =\< 6) up to Week 12||4.71|2.26|< 0.001
91597214|NCT05032157|183085684|SUPERIORITY||Rate ratio|1.32|||<|0.001|TWO_SIDED|95.0|1.17|1.49|||Regression, Linear||Negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates. A rate ratio \> 1 favors LOU064 25 mg b.i.d.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.49|1.17|< 0.001
91790420|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91597215|NCT02049944|183085700|OTHER|we used t-test on the regression coefficient for the group indicator to test for differences in means categorical variables were evaluated using fisher's exact test of association linear regression for log transformed start adipose concentrations were calculated by dose specific group|Median Difference (Final Values)|80.0|||||TWO_SIDED|95.0|||||Fisher Exact|||To detect the number of subjects who obtained a minimal inhibitory concentration (\>4mg/ml) following increased 3g dose of cefazolin. Compare this number to the historical cohort who had received 2g of cefazolin (standard dosing)||||
91597216|NCT03691974|183085713|SUPERIORITY||Least Square (LS) Mean Difference|0.4||||0.4192|TWO_SIDED|95.0|-0.55|1.32||Analyses are based on Mixed Model for Repeated Measures (MMRM) model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|Mixed Model for Repeated Measures (MMRM)|||||1.32|-0.55|0.4192
91597217|NCT03691974|183085714|SUPERIORITY||LS Mean Difference|0.4||||0.0521|TWO_SIDED|95.0|0.0|0.8||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||0.80|-0.00|0.0521
91597218|NCT03691974|183085715|SUPERIORITY||LS Mean Difference|1.3||||0.1593|TWO_SIDED|95.0|-0.52|3.15||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||3.15|-0.52|0.1593
91597219|NCT03691974|183085716|SUPERIORITY||LS Mean Difference|-0.2||||0.7757|TWO_SIDED|95.0|-1.59|1.19||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.19|-1.59|0.7757
91597220|NCT03691974|183085717|SUPERIORITY||LS Mean Difference|-0.4||||0.6063|TWO_SIDED|95.0|-1.87|1.09||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.09|-1.87|0.6063
91597221|NCT03691974|183085718|SUPERIORITY||LS Mean Difference|-1.0||||0.4203|TWO_SIDED|95.0|-3.3|1.39||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.39|-3.30|0.4203
91597222|NCT03691974|183085719|SUPERIORITY||LS Mean Difference|-1.33||||0.001|TWO_SIDED|95.0|-2.123|-0.538||Analyses are based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.538|-2.123|0.0010
91597223|NCT03691974|183085720|SUPERIORITY||LS Mean Difference|-1.42||||0.0005|TWO_SIDED|95.0|-2.212|-0.625||Analyses were based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.625|-2.212|0.0005
91597224|NCT03962439|183085730|OTHER|Null-hypothesis significance testing|F-value|1.61||||0.211|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in episodic memory from baseline to 16 weeks interacted with condition (Time x Condition).||||.211
91597225|NCT03962439|183085732|OTHER|Null hypothesis significance testing|F-value|1.66||||0.203|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in speed of processing from baseline to 16 weeks interacted with condition (Time x Condition).||||.203
91597226|NCT03962439|183085734|OTHER|Null hypothesis significance testing|F-value|0.28||||0.76|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in reasoning from baseline to week 16 interacted with condition (Time x Condition).||||.760
91597227|NCT00746252|183085743|OTHER|||||||0.495||||||Threshold of significance is p\<.05|t-test, 2 sided|||Comparison of mean weight gain between groups.||||.495
91597228|NCT01137773|183085781|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
91597229|NCT01137773|183085782|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
91597230|NCT00439946|183085783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
91597231|NCT00439946|183085784|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91597232|NCT00439946|183085785|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91597233|NCT00439946|183085786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
91709361|NCT01402986|183311375|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.03|TWO_SIDED|95.0|0.03|0.6|||Repeated measure model|||Without chronic OCS use||0.60|0.03|0.030
91597234|NCT00439946|183085787|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
91597235|NCT00439946|183085788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
91597236|NCT00439946|183085789|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
91597237|NCT00439946|183085790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.75
91597238|NCT00439946|183085791|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
91597239|NCT00439946|183085792|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
91649396|NCT04133519|183191431|SUPERIORITY||Mean Difference (Net)|2.372||||0.3676|TWO_SIDED|95.0|-2.793|7.537|||Mixed Models Analysis|||The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model: parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random||7.537|-2.793|0.3676
91649397|NCT00323609|183191432|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Fisher Exact|||||||0.214
91597240|NCT00439946|183085793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||p-value for: Gather/set-up|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.95
91597241|NCT00439946|183085793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||p-value for: Prepare drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.02
91597242|NCT00439946|183085793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0||||p-value for: Connect drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.20
91649398|NCT00323609|183191433|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 7 days.||||0.430
91649399|NCT00323609|183191433|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.655
91597243|NCT00439946|183085793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||p-value for: Change dressing|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.48
91597244|NCT00439946|183085793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||p-value for: Total time|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.11
91597245|NCT00439946|183085794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||p-value for: CAMPHOR Symptom Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
91597246|NCT00439946|183085794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0||||p-value for CAMPHOR Activity Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
91597247|NCT00439946|183085794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p-value for CAMPHOR Quality of Life Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
91597248|NCT00439946|183085794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||p-value for CAMPHOR Total Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.22
91597249|NCT00439946|183085795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||p-value for TSQM Effectiveness Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.55
91649400|NCT00323609|183191433|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.756
91649401|NCT00323609|183191433|SUPERIORITY_OR_OTHER|||||||0.503||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.503
91649402|NCT00323609|183191433|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.837
91649403|NCT00323609|183191434|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days||||0.785
91597250|NCT00439946|183085795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||p-value for TSQM Side-Effects Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
91597251|NCT00439946|183085795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||p-value for TSQM Convenience Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.01
91649404|NCT00323609|183191434|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.393
91649405|NCT00323609|183191434|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months||||0.875
91597252|NCT00439946|183085795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0||||p-value for TSQM Global Satisfaction Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.52
91597253|NCT03548051|183085801|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
91597254|NCT03548051|183085804|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
91597255|NCT03548051|183085805|SUPERIORITY||||||>|0.999||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||A Log-Rank permutation test for small samples was used to test the null hypothesis that there is no difference in the time to first CDAD recurrence between treatment arms.||||>0.999
91597256|NCT00812214|183085820|SUPERIORITY|For the purpose of the power calculation, it was assumed that the difference in total sleep time between the treatment groups is 40 minutes, with a standard deviation of 60. The pilot nature of the study allowed the use of alpha = 0.05 and beta = 0.2, with two-sided comparison, generating a required sample size of 37 subjects per arm.||||||0.33|||||||t-test, 2 sided|two-tailed student's t-test for independent samples||The null hypothesis is that there is no difference in the 6 week average total sleep time||||0.33
91649406|NCT00323609|183191434|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.833
91649407|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 30 days.||||0.180
91597257|NCT00812214|183085821|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between the eszopiclone and placebo groups in the number of awakenings/night at 6 weeks.||||0.03
91790421|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.188||0.157|TWO_SIDED|95.0|-0.635|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.103|-0.635|0.157
91597258|NCT00812214|183085823|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in sleep quality averaged over 6 weeks of treatment.||||0.1
91597259|NCT00812214|183085823|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime alertness averaged over 6 weeks of treatment.||||0.29
91597260|NCT00812214|183085823|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime fatigue averaged over 6 weeks of treatment.||||0.05
91597261|NCT00812214|183085823|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime functioning averaged over 6 weeks of treatment.||||0.76
91597262|NCT00812214|183085825|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in average days/week between eszopiclone and placebo groups at 6 weeks.||||0.89
91597263|NCT00812214|183085826|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache duration between eszopiclone and placebo groups at 6 weeks.||||0.98
91597264|NCT00812214|183085827|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache intensity between eszopiclone and placebo groups at 6 weeks.||||0.82
91597265|NCT03325673|183085838|SUPERIORITY|||||||0.116|||||||Independent t-test|||||||0.116
91597266|NCT03325673|183085839|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Insertion||||0.468
91597267|NCT03325673|183085839|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||After 2 hours||||0.235
91597268|NCT03325673|183085839|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||End of Day||||0.152
91597269|NCT03325673|183085840|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
91597270|NCT03325673|183085841|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
91597271|NCT02684981|183085842|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in PACT-Q2 scores from V1 to V2||||< 0.0001
91597272|NCT02684981|183085842|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3||||< 0.0001
91597273|NCT02684981|183085843|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2||||< 0.0001
91597274|NCT02684981|183085843|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3||||< 0.0001
91597275|NCT02684981|183085844|OTHER||Mean Difference (Net)|18.377|STANDARD_ERROR_OF_MEAN|0.514|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
91597276|NCT02684981|183085844|OTHER||Mean Difference (Net)|23.341|STANDARD_ERROR_OF_MEAN|0.509|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
91597277|NCT02684981|183085845|OTHER||Mean Difference (Net)|15.884|STANDARD_ERROR_OF_MEAN|0.388|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
91597278|NCT02684981|183085845|OTHER||Mean Difference (Net)|19.011|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
91597279|NCT02684981|183085853|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessment||||< 0.001
91597280|NCT00452699|183085877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||<|0.001||95.0|0.07|0.15|||ANCOVA|||||0.15|0.07|<0.001
91597281|NCT01602692|183085881|OTHER|||||||0.24|||||||ANOVA|||End of PACU Mean Pain Level p-value between arms||||0.24
91597282|NCT01602692|183085881|OTHER|||||||0.76|||||||ANOVA|||First 24 hrs Post-op Mean Current Pain p-value between arms||||0.76
91790422|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|1.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790423|NCT02880956|183460063|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.192||0.283|TWO_SIDED|95.0|-0.585|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.172|-0.585|0.283
91790424|NCT02880956|183460063|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790425|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.363|TWO_SIDED|95.0|-0.085|0.231||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.231|-0.085|0.363
91784376|NCT01235598|183449205|SUPERIORITY_OR_OTHER||Median difference within group changes|-1.5||||0.049|TWO_SIDED|95.0|-3.0|0.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0|-3.0|0.049
91784377|NCT01235598|183449206|SUPERIORITY_OR_OTHER||Median Difference within group changes|-1.0||||0.206|TWO_SIDED|95.0|-3.0|1.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \< 0.05). Hypothesis testing was stopped if and when a non-significant result was obtained. Testing was stopped in the next step.||1.0|-3.0|0.206
91784378|NCT01235598|183449210|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.0035||||0.164|TWO_SIDED|95.0|-0.012|0.0025||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0025|-0.0120|0.164
91784379|NCT01235598|183449211|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.069||||0.865|TWO_SIDED|95.0|-0.201|0.138||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.1380|-0.2010|0.865
91784380|NCT01235598|183449212|SUPERIORITY_OR_OTHER||Median difference within group changes|-421.5||||0.015|TWO_SIDED|95.0|-1542.5|-47.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||-47.0|-1542.5|0.015
91522397|NCT04672941|182919713|OTHER|The logistic generalized estimating equations (GEE) model with self-care as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|2.64|||<|0.001|TWO_SIDED|95.0|2.35|2.96|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||2.96|2.35|< 0.001
91522398|NCT04672941|182919714|OTHER|The logistic generalized estimating equations (GEE) model with usual activities as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.46|||<|0.001|TWO_SIDED|95.0|3.89|5.12|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.12|3.89|< 0.001
91522399|NCT04672941|182919715|OTHER|The logistic generalized estimating equations (GEE) model with pain/discomfort as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|3.0|3.85|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.85|3.00|< 0.001
91649408|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 3 months||||0.822
91522400|NCT04672941|182919716|OTHER|The logistic generalized estimating equations (GEE) model with anxiety/depression as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.32|||<|0.001|TWO_SIDED|95.0|2.95|3.73|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.73|2.95|< 0.001
91522401|NCT04672941|182919722|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the mMRC score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-0.55|||||TWO_SIDED|95.0|-0.6|-0.51|||||Least Square Mean for Visit, change from baseline (3 months - baseline) of mMRC based on non-responder imputation.|||-0.51|-0.60|
91649409|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 12 months||||0.291
91597283|NCT01602692|183085881|OTHER|||||||0.78|||||||ANOVA|||First 24 hrs Post-op Mean Worst Pain p-value between arms||||0.78
91597284|NCT01602692|183085881|OTHER|||||||0.41|||||||ANOVA|||First 24 hrs Post-op Mean Least Pain p-value between arms||||0.41
91597285|NCT01602692|183085882|OTHER|||||||0.1|||||||ANOVA|||PACU IV hydromorphone p-value between arms||||0.10
91597286|NCT01602692|183085882|OTHER|||||||0.71|||||||ANOVA|||First 24 hr Post-op oxycodone p-value between arms||||0.71
91597287|NCT00326898|183085888|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|97.5|0.85|1.23|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.23|0.85|0.80
91597288|NCT00326898|183085888|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|97.5|0.8|1.17|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.17|0.80|0.72
91597289|NCT00326898|183085889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|97.5|0.9|1.52|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.52|0.90|
91597290|NCT00326898|183085889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|97.5|0.75|1.28|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.28|0.75|
91597291|NCT04175626|183085909|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint was evaluated by performing an exact, binomial test comparing the rate of TLF for the Orsiro stent at 1 year to a performance goal of 6.9%, with Type I error (alpha) of 0.025 and power of 80%. The null hypothesis (Ho) was stated as: The TLF rate of the Orsiro stent at 1 year is greater than or equal to 6.9%. The alternative hypothesis (Ha) was stated as: The TLF rate of the Orsiro stent at 1 year is less than 6.9%.||||<0.0001
91597292|NCT01709149|183085926|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.366||0.114|TWO_SIDED|95.0|-1.3|0.14|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||0.14|-1.30|0.1140
91597293|NCT01709149|183085927|SUPERIORITY||Least squares mean difference|0.48|STANDARD_ERROR_OF_MEAN|1.963||0.8083|TWO_SIDED|95.0|-3.38|4.34|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||4.34|-3.38|0.8083
91597294|NCT01709149|183085928|SUPERIORITY||Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.627||0.0372|TWO_SIDED|95.0|-6.6|-0.2|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||-0.20|-6.60|0.0372
91597295|NCT01709149|183085929|SUPERIORITY||Least squares mean difference|4.25|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.23|6.28|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||6.28|2.23|<0.0001
91597296|NCT01709149|183085930|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.956||0.4328|TWO_SIDED|95.0|-1.13|2.63|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||2.63|-1.13|0.4328
91597297|NCT01709149|183085931|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|4.399||0.9546|TWO_SIDED|95.0|-8.4|8.9|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||8.90|-8.40|0.9546
91597298|NCT01709149|183085932|SUPERIORITY||Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|3.207||0.6166|TWO_SIDED|95.0|-4.7|7.91|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||7.91|-4.70|0.6166
91597299|NCT00763815|183085952|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.731|-0.386||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.386|-0.731|<0.0001
91597300|NCT02429414|183086006|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91597301|NCT02429414|183086007|SUPERIORITY|||||||0.0209|||||||t-test, 2 sided|||||||0.0209
91597302|NCT02429414|183086008|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
91597303|NCT01849172|183086010|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91597304|NCT01604265|183086026|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.25||||0.005|TWO_SIDED|95.0|-2.11|-0.39|||ANCOVA|||The change was compared between treatment groups using a one way analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows: Change in 0-10 Numerical Rating Scale Pain Score = Baseline Pain Score + Treatment||-0.39|-2.11|0.005
91597305|NCT01604265|183086027|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.39||||0.003|TWO_SIDED|95.0|-2.27|-0.5|||ANCOVA|||"The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in 0-10 Numerical Rating Scale sleep Score = Baseline Sleep Score + Treatment"||-0.50|-2.27|0.003
91597306|NCT01604265|183086028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.896||||0.005|TWO_SIDED|95.0|1.51|10.055|||Regression, Logistic|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test. Results were presented in terms of difference in percentages, and 95% CI based on the normal approximation to the binomial, and p-value."||10.055|1.510|0.005
91597307|NCT01604265|183086029|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-6.82||||0.039|TWO_SIDED|95.0|-13.28|-0.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-0.37|-13.28|0.039
91784381|NCT01235598|183449224|SUPERIORITY_OR_OTHER|||||||0.394|||||||Spearman rank correlation|||||||0.394
91597308|NCT01604265|183086030|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.95||||0.009|TWO_SIDED|95.0|-12.12|-1.77|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-1.77|-12.12|0.009
91597309|NCT01604265|183086031|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.54||||0.23|TWO_SIDED|95.0|-1.64|6.71|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||6.71|-1.64|0.230
91597310|NCT01604265|183086032|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.53||||0.064|TWO_SIDED|95.0|-5.22|0.15|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.15|-5.22|0.064
91597311|NCT01604265|183086033|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.44||0.905|TWO_SIDED|95.0|-4.6|5.18|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||5.18|-4.60|0.905
91597312|NCT01604265|183086034|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.68||||0.257|TWO_SIDED|95.0|-2.01|7.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||7.37|-2.01|0.257
91597313|NCT01604265|183086035|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.5||||0.164|TWO_SIDED|95.0|-3.64|0.63|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.63|-3.64|0.164
91597314|NCT01604265|183086037|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.09||||0.88|TWO_SIDED|95.0|-1.06|1.23|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||1.23|-1.06|0.880
91649410|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.996||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 24 months||||0.996
91597315|NCT01604265|183086038|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.249|TWO_SIDED|95.0|-1.75|0.46|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.46|-1.75|0.249
91597316|NCT01604265|183086039|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.06||||0.535|TWO_SIDED|95.0|-0.13|0.24|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.24|-0.13|0.535
91649411|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 30 days||||0.983
91649412|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 3 months||||0.576
91597317|NCT04442230|183086041|SUPERIORITY|||||||0.6602|||||||Fisher Exact|||The p-values from significance tests were obtained at a one-sided significance level of 0.025.||||0.6602
91597318|NCT01903837|183086044|EQUIVALENCE|Equivalence margin of 10 points|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-2.0|2.6|||Least Square Mean Difference|||||2.6|-2.0|0.3
91597319|NCT01903837|183086045|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
91597320|NCT01903837|183086045|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91597321|NCT01903837|183086046|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
91597322|NCT01903837|183086046|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91613598|NCT00121810|183121491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||0.015||95.0|1.7|15.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||15.9|1.7|0.015
91613599|NCT00121810|183121492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|||<|0.001||95.0|4.2|12.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||12.9|4.2|<0.001
91649413|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 12 months||||0.393
91649414|NCT00323609|183191435|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 24 months||||0.722
91784382|NCT01235598|183449225|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Spearman rank correlation|||||||0.625
91784383|NCT01235598|183449226|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Spearman rank correlation|||||||0.128
91784384|NCT01235598|183449227|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Spearman rank correlation|||||||0.732
91784385|NCT01235598|183449228|SUPERIORITY_OR_OTHER|||||||0.411|TWO_SIDED||||||Spearman rank correlation|||||||0.411
91784386|NCT01235598|183449229|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman rank correlation|||||||0.208
91784387|NCT01235598|183449230|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.254|TWO_SIDED|95.0|-1.0|0.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||0.0|-1.0|0.254
91784388|NCT01235598|183449231|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.472|TWO_SIDED|95.0|-2.0|1.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||1.0|-2.0|0.472
91597323|NCT02706873|183086049|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|23.7|||<|0.001|TWO_SIDED|95.0|16.3|31.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||31.1|16.3|<0.001
91597324|NCT02706873|183086049|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|20.6|35.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||35.4|20.6|<0.001
91597325|NCT02706873|183086050|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|29.8|||<|0.001|TWO_SIDED|95.0|22.8|36.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||36.8|22.8|<0.001
91597326|NCT02706873|183086050|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|24.5|38.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||38.5|24.5|<0.001
91522402|NCT00386022|182919733|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH as a function of dose in young or old postmenopausal women|||||<|0.001||||||LH % change with dose|Repeated measures ANCOVA|||||||<0.001
91613600|NCT00121810|183121492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8||||0.059||95.0|-0.2|11.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||11.9|-0.2|0.059
91613601|NCT00121810|183121492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.036||95.0|0.5|14.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||14.5|0.5|0.036
91613602|NCT00798967|183121493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Cochran-Mantel-Haenszel (CMH) test adjusted for the randomization stratification variable (\<= 6 or \> 6 L/week of PN at baseline)|Cochran-Mantel-Haenszel|||||||0.002
91613603|NCT00798967|183121494|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Last Dosing Visit||||< 0.001
91613604|NCT01354691|183121495|SUPERIORITY||||||<|0.67|||||||ANCOVA|||||||<0.67
91613605|NCT01354691|183121496|SUPERIORITY||||||<|0.21|||||||ANCOVA|||||||<0.21
91613606|NCT01354691|183121497|SUPERIORITY||||||<|0.78|||||||ANCOVA|||||||<0.78
91613607|NCT01354691|183121498|SUPERIORITY||||||=|0.83|||||||ANCOVA|||||||=0.83
91613608|NCT01354691|183121499|SUPERIORITY||||||=|0.77|||||||ANCOVA|||||||=.77
91613609|NCT04083222|183121502|SUPERIORITY||||||<|0.001||||||P-value was analyzed using Analysis of Variance (ANOVA) with treatment and screening angiotensin-converting enzyme inhibitor/ angiotensin receptor blockers (ACEi/ARB) dose status stratification factor.|ANOVA|||||||< 0.001
91613610|NCT04083222|183121503|SUPERIORITY|||||||0.399||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.399
91597327|NCT02706873|183086051|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|21.6|||<|0.001|TWO_SIDED|95.0|14.3|28.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||28.8|14.3|<0.001
91597328|NCT02706873|183086051|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|15.7|30.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||30.1|15.7|<0.001
91597329|NCT02706873|183086052|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Least Squares (LS) Mean Difference|-0.53||||0.001|TWO_SIDED|95.0|-0.85|-0.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, geographic region as fixed factors and baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.20|-0.85|0.001
91597330|NCT02706873|183086052|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.91|-0.27||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.27|-0.91|<0.001
91597331|NCT02706873|183086053|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.09|-0.67||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.||||-0.67|-1.09|<0.001
91597332|NCT02706873|183086053|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.21|-0.8||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.80|-1.21|<0.001
91597333|NCT02706873|183086054|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.25||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.25|-0.44|<0.001
91597334|NCT02706873|183086054|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.47|-0.28||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.28|-0.47|<0.001
91522403|NCT00386022|182919733|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH between younger and older postmenopausal women|||||<|0.03||||||LH % change with age|Repeated measures ANCOVA|||null hypothesis: there will be no difference in the LH and FSH responses to graded doses of GnRH between younger and older postmenopausal women||||<0.03
91597335|NCT02706873|183086055|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|25.0|||<|0.001|TWO_SIDED|95.0|17.6|32.4||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||32.4|17.6|<0.001
91613611|NCT04083222|183121503|SUPERIORITY|||||||0.338||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||0.338
91613612|NCT04083222|183121503|SUPERIORITY|||||||0.207||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||0.207
91613613|NCT04083222|183121503|SUPERIORITY|||||||0.927||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||0.927
91597336|NCT02706873|183086055|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|26.4|||<|0.001|TWO_SIDED|95.0|19.0|33.9||The nominal p-value is reported|Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|||Response Rate Difference = Upadacitinib - Methotrexate|33.9|19.0|<0.001
91597337|NCT02706873|183086056|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.25|||<|0.001|TWO_SIDED|95.0|3.0|5.5||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.50|3.00|<0.001
91597338|NCT02706873|183086056|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|3.09|5.59||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.59|3.09|<0.001
91597339|NCT02706873|183086057|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.12|-0.71||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.71|-1.12|<0.001
91597340|NCT02706873|183086057|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-1.19|||<|0.001|TWO_SIDED|95.0|-1.4|-0.99||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.99|-1.40|<0.001
91597341|NCT02706873|183086058|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.17|-0.37|<0.001
91597342|NCT02706873|183086058|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.21|-0.41|<0.001
91597343|NCT02706873|183086059|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|26.8|||<|0.001|TWO_SIDED|95.0|19.3|34.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||34.3|19.3|<0.001
91597344|NCT02706873|183086059|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.2|||<|0.001|TWO_SIDED|95.0|24.8|39.6||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||39.6|24.8|<0.001
91597345|NCT02706873|183086060|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|27.8|||<|0.001|TWO_SIDED|95.0|20.3|35.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||35.2|20.3|<0.001
91649415|NCT00323609|183191436|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.318
91649416|NCT00323609|183191436|SUPERIORITY_OR_OTHER|||||||0.523||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.523
91649417|NCT00323609|183191436|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.634
91649418|NCT00323609|183191436|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.457
91649419|NCT00323609|183191437|SUPERIORITY_OR_OTHER|||||||0.818||95.0|||||Fisher Exact|||||||0.818
91649420|NCT00323609|183191438|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||||||0.226
91649421|NCT00323609|183191439|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91597346|NCT02706873|183086060|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.8|||<|0.001|TWO_SIDED|95.0|25.4|40.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||40.2|25.4|<0.001
91597347|NCT02706873|183086061|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|3.72|||<|0.001|TWO_SIDED|95.0|2.42|5.03||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.03|2.42|<0.001
91597348|NCT02706873|183086061|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|4.42|||<|0.001|TWO_SIDED|95.0|3.12|5.72||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.72|3.12|<0.001
91597349|NCT02706873|183086062|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|9.8||||0.002|TWO_SIDED|95.0|3.5|16.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||16.2|3.5|0.002
91597350|NCT02706873|183086062|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|11.6|||<|0.001|TWO_SIDED|95.0|5.4|17.8||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||17.8|5.4|<0.001
91597351|NCT02706873|183086063|SUPERIORITY||Response Rate Difference|18.5|||<|0.001|TWO_SIDED|95.0|12.1|24.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||24.9|12.1|<0.001
91597352|NCT02706873|183086063|OTHER||Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|16.4|29.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||29.5|16.4|<0.001
91597353|NCT02706873|183086064|SUPERIORITY||Response Rate Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.2|27.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||27.3|13.2|<0.001
91597354|NCT02706873|183086064|SUPERIORITY||Response Rate Difference|19.4|||<|0.001|TWO_SIDED|95.0|12.3|26.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||26.5|12.3|<0.001
91597355|NCT02706873|183086065|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.1|33.0||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||33.0|19.1|<0.001
91597356|NCT02706873|183086065|SUPERIORITY||Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|24.2|38.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||38.2|24.2|<0.001
91597357|NCT02706873|183086066|SUPERIORITY|For the Japan sub-study, no multiplicity adjustments were applied and only nominal p-values were provided for all efficacy analyses.|Response Rate Difference|28.3||||0.004|TWO_SIDED|95.0|7.7|48.9|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||48.9|7.7|0.004
91597358|NCT02706873|183086066|SUPERIORITY||Response Rate Difference|28.0||||0.022|TWO_SIDED|95.0|5.3|50.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||50.7|5.3|0.022
91597359|NCT02706873|183086066|SUPERIORITY||Response Rate Difference|21.4||||0.086|TWO_SIDED|95.0|-2.4|45.2|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||45.2|-2.4|0.086
91597360|NCT02706873|183086067|SUPERIORITY||Response Rate Difference|38.6|||<|0.001|TWO_SIDED|95.0|18.6|58.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.5|18.6|<0.001
91597361|NCT02706873|183086067|SUPERIORITY||Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|21.8|68.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.6|21.8|<0.001
91649422|NCT00323609|183191440|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.112
91597362|NCT02706873|183086067|SUPERIORITY||Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|27.4|72.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||72.6|27.4|<0.001
91597363|NCT02706873|183086068|SUPERIORITY||Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|22.0|47.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||47.1|22.0|<0.001
91597364|NCT02706873|183086068|SUPERIORITY||Response Rate Difference|51.9|||<|0.001|TWO_SIDED|95.0|33.0|70.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.7|33.0|<0.001
91597365|NCT02706873|183086068|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|46.5|82.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||82.0|46.5|<0.001
91597366|NCT02706873|183086069|SUPERIORITY||LS Mean Difference|-1.43|||<|0.001|TWO_SIDED|95.0|-1.92|-0.95|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.95|-1.92|<0.001
91597367|NCT02706873|183086069|SUPERIORITY||LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.42|-1.3|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.30|-2.42|<0.001
91597368|NCT02706873|183086069|SUPERIORITY||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.48|-1.36|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.36|-2.48|<0.001
91597369|NCT02706873|183086070|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.34|-0.75|<0.001
91597370|NCT02706873|183086070|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
91597371|NCT02706873|183086070|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
91597372|NCT02706873|183086071|SUPERIORITY||LS Mean Difference|5.97|||<|0.001|TWO_SIDED|95.0|3.15|8.8|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||8.80|3.15|<0.001
91649423|NCT00323609|183191440|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.364
91649424|NCT00323609|183191440|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.185
91649425|NCT00323609|183191440|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.100
91597373|NCT02706873|183086071|SUPERIORITY||LS Mean Difference|7.92|||<|0.001|TWO_SIDED|95.0|4.66|11.19|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||11.19|4.66|<0.001
91597374|NCT02706873|183086071|SUPERIORITY||LS Mean Difference|6.76|||<|0.001|TWO_SIDED|95.0|3.33|10.2|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||10.20|3.33|<0.001
91597375|NCT02706873|183086072|SUPERIORITY||Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|32.5|70.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.0|32.5|<0.001
91597376|NCT02706873|183086072|SUPERIORITY||Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|38.8|81.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.1|38.8|<0.001
91597377|NCT02706873|183086072|SUPERIORITY||Response Rate Difference|60.7|||<|0.001|TWO_SIDED|95.0|39.9|81.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.5|39.9|<0.001
91597378|NCT02706873|183086073|SUPERIORITY||Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|30.6|68.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.3|30.6|<0.001
91597379|NCT02706873|183086073|SUPERIORITY||Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|30.2|74.8|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||74.8|30.2|<0.001
91597380|NCT02706873|183086073|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|44.2|84.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||84.3|44.2|<0.001
91597381|NCT02706873|183086074|SUPERIORITY||LS Mean Difference|-1.69||||0.063|TWO_SIDED|95.0|-3.47|0.09|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||0.09|-3.47|0.063
91597382|NCT02706873|183086074|SUPERIORITY||LS Mean Difference|-2.4||||0.022|TWO_SIDED|95.0|-4.45|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.45|0.022
91597383|NCT02706873|183086074|SUPERIORITY||LS Mean Difference|-2.45||||0.022|TWO_SIDED|95.0|-4.54|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.54|0.022
91597384|NCT02706873|183086075|SUPERIORITY||Response Rate Difference|36.2||||0.001|TWO_SIDED|95.0|14.4|58.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.0|14.4|0.001
91597385|NCT02706873|183086075|SUPERIORITY||Response Rate Difference|34.6||||0.01|TWO_SIDED|95.0|10.2|59.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||59.0|10.2|0.010
91597386|NCT02706873|183086075|SUPERIORITY||Response Rate Difference|33.0||||0.016|TWO_SIDED|95.0|7.9|58.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.1|7.9|0.016
91597387|NCT01857713|183086076|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|||||<|0.05|||||||t-test, 1 sided|||The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.||||<0.05
91649426|NCT00323609|183191441|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.005
91649427|NCT00323609|183191441|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.382
91784389|NCT00395343|183449232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.7|-0.42|||ANCOVA|Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)||||-0.42|-0.70|<0.001
91784390|NCT00395343|183449233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.001||95.0|-23.4|-6.5|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-6.5|-23.4|<0.001
91597388|NCT05098041|183086082|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90 percent (%) confidence intervals (CIs) for the Geometric Mean Ratio (GMR) of Cmax for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the natural-log (ln)-transformed Cmax.|Geometric Mean Ratio (%)|13.15|||||TWO_SIDED|90.0|9.73|17.79|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||17.79|9.73|
91597389|NCT05098041|183086083|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUC∞ for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.|Geometric Mean Ratio (%)|16.42|||||TWO_SIDED|90.0|12.53|21.5|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||21.50|12.53|
91597390|NCT05098041|183086084|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUClast for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.|Geometric Mean Ratio (%)|14.92|||||TWO_SIDED|90.0|11.94|18.64|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||18.64|11.94|
91597391|NCT05098041|183086085|OTHER||Median Difference (Final Values)|-0.117|||=|0.0791|TWO_SIDED|90.0|-0.202|0.0|||Wilcoxon Signed-Rank Test||Difference was calculated as (Soticlestat + Rifampin) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.000|-0.202|=0.07910
91597392|NCT03759665|183086087|SUPERIORITY||Hodges-Lehmann Estimator|0.75||||0.044|TWO_SIDED|90.0|0.0|1.5|||1-sided Wilcoxon signed-rank test|||||1.50|0.00|0.044
91597393|NCT03759665|183086089|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.206|TWO_SIDED|90.0|-0.13|0.25|||1-sided Wilcoxon signed-rank test|||||0.25|-0.13|0.206
91597394|NCT03759665|183086092|SUPERIORITY||Hodges-Lehmann Estimator|0.0327||||0.21|TWO_SIDED|90.0|-0.0327|0.104|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1040|-0.0327|0.210
91784391|NCT00395343|183449234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.1|||<|0.001||95.0|-47.1|-25.1|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-25.1|-47.1|<0.001
91784392|NCT00395343|183449235|SUPERIORITY_OR_OTHER||Geometric Mean Difference|36.5||||0.01||95.0|8.9|64.7|||ANCOVA|Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum||||64.7|8.9|0.01
91597395|NCT03759665|183086092|SUPERIORITY||Hodges-Lehmann Estimator|-0.0291||||0.212|TWO_SIDED|90.0|-0.0863|0.0262|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.0262|-0.0863|0.212
91597396|NCT03759665|183086093|SUPERIORITY||Hodges-Lehmann Estimator|-1.25|||<|0.001|TWO_SIDED|90.0|-1.75|-0.75|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.75|-1.75|<0.001
91597397|NCT03759665|183086093|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.001|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.001
91597398|NCT03759665|183086095|SUPERIORITY||Hodges-Lehmann Estimator|-0.031||||0.02|TWO_SIDED|90.0|-0.063|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.063|0.020
91597399|NCT03759665|183086095|SUPERIORITY||Hodges-Lehmann Estimator|0.042|||<|0.001|TWO_SIDED|90.0|0.021|0.063|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.063|0.021|<0.001
91597400|NCT03759665|183086096|SUPERIORITY||Hodges-Lehmann Estimator|3.0|||<|0.001|TWO_SIDED|90.0|3.0|3.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||3.5|3.0|<0.001
91597401|NCT03759665|183086096|SUPERIORITY||Hodges-Lehmann Estimator|5.0|||<|0.001|TWO_SIDED|90.0|4.5|5.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||5.0|4.5|<0.001
91597402|NCT00797732|183086108|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||.17
91597403|NCT01297270|183086123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
91597404|NCT01297270|183086123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.4|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||27.4|7.3|0.0007
91597405|NCT01297270|183086124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
91613614|NCT04083222|183121503|SUPERIORITY|||||||0.146||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||0.146
91613615|NCT04083222|183121503|SUPERIORITY|||||||0.055||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||0.055
91613616|NCT04083222|183121503|SUPERIORITY|||||||0.095||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||0.095
91613617|NCT04083222|183121503|SUPERIORITY|||||||0.046||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||0.046
91522404|NCT00386022|182919733|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH as a function of dose in younger or older postmenopausal women|||||<|0.001||||||FSH % change with dose|Repeated measures ANCOVA|||||||<0.001
91597406|NCT01297270|183086124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6||||0.0014|TWO_SIDED|95.0|6.5|26.7|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||26.7|6.5|0.0014
91597407|NCT02112370|183086134|SUPERIORITY_OR_OTHER|||||||0.008||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Swallowing difficulty||||0.008
91597408|NCT02112370|183086134|SUPERIORITY_OR_OTHER|||||||0.016||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Anterior neck pain||||0.016
91597409|NCT02112370|183086134|SUPERIORITY_OR_OTHER|||||||0.019||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Right chest pain||||0.019
91597410|NCT02112370|183086134|SUPERIORITY_OR_OTHER|||||||0.035||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Left chest pain||||0.035
91597411|NCT02112370|183086134|SUPERIORITY_OR_OTHER|||||||0.089||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Back pain||||0.089
91597412|NCT02112370|183086134|SUPERIORITY_OR_OTHER|||||||0.634||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Posterior neck pain||||0.634
91597413|NCT02873936|183086177|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.5|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||46.3|23.5|<0.001
91597414|NCT02873936|183086177|SUPERIORITY||Difference in Response Rates|26.4|||<|0.001|TWO_SIDED|95.0|15.0|37.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||37.9|15.0|<0.001
91597415|NCT02873936|183086178|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.45|-0.19||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.45|<0.001
91597416|NCT02873936|183086178|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.4|-0.14||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.14|-0.40|<0.001
91597417|NCT02873936|183086179|SUPERIORITY||Difference in Response Rates|25.3|||<|0.001|TWO_SIDED|95.0|14.7|35.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||35.8|14.7|<0.001
91597418|NCT02873936|183086179|SUPERIORITY||Difference in Response Rates|21.7|||<|0.001|TWO_SIDED|95.0|11.4|32.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||32.0|11.4|<0.001
91597419|NCT02873936|183086180|SUPERIORITY||Least Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|2.5|6.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.1|2.5|<0.001
91597420|NCT02873936|183086180|SUPERIORITY||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.6|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.6|<0.001
91597421|NCT02873936|183086181|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|8.6|28.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||28.3|8.6|<0.001
91597422|NCT02873936|183086181|SUPERIORITY||Difference in Response Rates|14.0||||0.003|TWO_SIDED|95.0|4.6|23.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||23.4|4.6|0.003
91613618|NCT04083222|183121503|SUPERIORITY|||||||0.246||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||0.246
91613619|NCT04083222|183121503|SUPERIORITY|||||||0.17||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||0.170
91613620|NCT04083222|183121503|SUPERIORITY|||||||0.527||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||0.527
91613621|NCT04083222|183121503|SUPERIORITY|||||||0.167||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||0.167
91613622|NCT04083222|183121503|SUPERIORITY|||||||0.266||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.266
91613623|NCT04083222|183121503|SUPERIORITY|||||||0.078||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.078
91613624|NCT04083222|183121504|SUPERIORITY|||||||0.661||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.661
91613625|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
91784393|NCT00395343|183449236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.001||95.0|1.89|6.85||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum||||6.85|1.89|<0.001
91522405|NCT00386022|182919733|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH between young and old postmenopausal women|||||<|0.005||||||FSH % change with age|Repeated measures ANCOVA|||||||<0.005
91522406|NCT00386022|182919734|EQUIVALENCE|null hypothesis will be accepted if there is no effect of estrogen on the LH response to GnRH in younger and older postmenopausal women|||||<|0.01||||||LH amplitude response with estrogen|Repeated measured ANCOVA|||||||<0.01
91522407|NCT00386022|182919734|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of estrogen on the FSH response to GnRH in younger and older postmenopausal women|||||<|0.0001||||||FSH amplitude response with estrogen|Repeated measures ANCOVA|||||||<0.0001
91522408|NCT00386022|182919734|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the FSH response to GnRH|||||<|0.02||||||FSH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||<0.02
91522409|NCT00386022|182919734|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the LH response to GnRH|||||=|0.4||||||LH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||=0.4
91522410|NCT03933826|182919775|SUPERIORITY||Average treatment estimate (ATE)|0.9|||<|0.05|TWO_SIDED|95.0|-0.6|2.4||We tested the hypothesis that the average treatment effect (ATE) is different from zero. This was the only hypothesis test in our primary manuscript, and so no adjustment for multiple comparisons is necessary.|TMLE|TMLE stands for targeted maximum likelihood estimation|The causal mean difference in outcomes if all patients had been treated with radical cystectomy versus with bladder-sparing therapy. A positive value indicates greater physical functioning associated with radical cystectomy.|||2.4|-0.6|<0.05
91522411|NCT03933826|182919778|OTHER|We did not conduct a hypothesis test for this outcome. We presented an estimate of the average treatment effect (ATE).|TMLE|1.2|||||TWO_SIDED|95.0|-0.5|2.9|||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A positive value indicates greater urinary health associated with radical cystectomy.|||2.9|-0.5|
91522412|NCT03933826|182919781|OTHER|We did not conduct a hypothesis test for this outcome. We presented an estimate of average treatment effect (ATE).|TMLE|-11.9|||||TWO_SIDED|95.0|-14.7|-9.0|||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A positive value indicates greater sexual health associated with radical cystectomy.|||-9.0|-14.7|
91597423|NCT02873936|183086182|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.6|7.3||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.3|2.6|<0.001
91597424|NCT02873936|183086182|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.18||0.007|TWO_SIDED|95.0|0.9|5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.5|0.9|0.007
91597425|NCT02873936|183086183|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.4|23.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||23.7|6.4|<0.001
91597426|NCT02873936|183086183|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.7|22.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||22.6|5.7|<0.001
91597427|NCT02873936|183086183|SUPERIORITY||Difference in Response Rates|28.0|||<|0.001|TWO_SIDED|95.0|17.5|38.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||38.5|17.5|<0.001
91597428|NCT02873936|183086183|SUPERIORITY||Difference in Response Rates|17.2|||<|0.001|TWO_SIDED|95.0|7.1|27.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||27.2|7.1|<0.001
91597429|NCT02873936|183086183|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|15.8|37.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||37.6|15.8|<0.001
91522413|NCT03933826|182919784|OTHER|We did not conduct a hypothesis test for this outcome. We presented an estimate of the average treatment effect (ATE).|TMLE|-1.4|||||TWO_SIDED|95.0|-2.5|-0.3|||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A negative value indicates worse bowel health associated with radical cystectomy.|||-0.3|-2.5|
91597430|NCT02873936|183086183|SUPERIORITY||Difference in Response Rates|16.4||||0.002|TWO_SIDED|95.0|5.9|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||26.9|5.9|0.002
91597431|NCT02873936|183086184|SUPERIORITY||Difference in Response Rates|3.4||||0.16|TWO_SIDED|95.0|-1.9|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||8.8|-1.9|0.16
91597432|NCT02873936|183086184|SUPERIORITY||Difference in Response Rates|5.8||||0.039|TWO_SIDED|95.0|0.0|11.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||11.6|-0.0|0.039
91613626|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
91784394|NCT00395343|183449237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.584||95.0|0.45|4.18||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|||4.18|0.45|0.584
91522414|NCT03933826|182919787|OTHER|We did not conduct a hypothesis test for this outcome. We presented an estimate of the average treatment effect (ATE).|TMLE|1.4|||||TWO_SIDED|95.0|0.2|2.6|||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A positive value indicates greater financial health associated with radical cystectomy.|||2.6|0.2|
91522415|NCT03933826|182919790|OTHER|We did not conduct a hypothesis test for this outcome. We presented an estimate of the average treatment effect (ATE).|TMLE|-2.4|||||TWO_SIDED|95.0|-3.1|-1.6|||||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A negative value indicates lower anxiety associated with radical cystectomy.|-1.6|-3.1|
91522416|NCT03933826|182919793|SUPERIORITY|We did not conduct a hypothesis test for this outcome. We presented an estimate of the average treatment effect (ATE).|TMLE|-1.0|||||TWO_SIDED|95.0|-1.8|-0.3|||||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A negative value indicates less depression associated with radical cystectomy.|-0.3|-1.8|
91522417|NCT03933826|182919796|OTHER|We did not conduct a hypothesis test for this outcome. We presented an estimate of the average treatment effect (ATE).|TMLE|0.03|||||TWO_SIDED|95.0|0.01|0.04|||||||The ATE is interpreted as the causal mean difference in outcomes if all patients had been treated with RC versus having been treated with BST. A positive value indicates greater quality of life associated with radical cystectomy.|0.04|0.01|
91522418|NCT03933826|182919799|OTHER|We did not conduct a hypothesis test for this outcome.|Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.33|1.59|||||Inverse probability weighted risk ratios calculated using quasi-Poisson regression. A weighted risk ratio \> 1 implies that participants who choose RC have a greater chance of surviving without recurrence than those who choose BST.|||1.59|1.33|
91522419|NCT03933826|182919802|OTHER|We did not conduct a hypothesis test for this outcome.|Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.94|1.03|||||Inverse probability weighted risk ratios calculated using quasi-Poisson regression. A weighted risk ratio \< 1 implies that participants who choose RC have a lower chance of surviving without metastasis than those who choose BST.|||1.03|0.94|
91522420|NCT03933826|182919805|OTHER|We did not conduct a hypothesis test for this outcome.|Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.73|0.88|||||Inverse probability weighted risk ratios calculated using quasi-Poisson regression. A weighted risk ratio \< 1 implies that participants who choose RC have a lower chance of surviving without cancer progression than those who choose BST.|||0.88|0.73|
91522421|NCT03933826|182919808|OTHER|We did not conduct a hypothesis test for this outcome.|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.96|1.01|||||Inverse probability weighted risk ratios calculated using quasi-Poisson regression. A weighted risk ratio \< 1 implies that participants who choose RC have a lower chance of surviving cancer than those who choose BST.|||1.01|0.96|
91522422|NCT03933826|182919811|SUPERIORITY|Inverse probability weighted risk ratios calculated using quasi-Poisson regression|Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.38|2.08|||||A weighted risk ratio \< 1 implies that participants who choose radical cystectomy have a lower chance of surviving than those who choose bladder-sparing therapy.|||2.08|0.38|
91522423|NCT02638948|182919814|SUPERIORITY||Estimate of Difference (%)|4.9||||0.5224|TWO_SIDED|95.0|-10.2|20.1||Threshold for significance = 0.05|Chi-squared|||||20.1|-10.2|0.5224
91522424|NCT02638948|182919814|SUPERIORITY||Estimate of Difference (%)|11.8||||0.136|TWO_SIDED|95.0|-3.6|27.2||Threshold for significance = 0.05|Chi-squared|||||27.2|-3.6|0.1360
91522425|NCT02638948|182919814|SUPERIORITY||Estimate of Difference (%)|0.1||||0.9922|TWO_SIDED|95.0|-20.5|20.7||Threshold for significance = 0.05|Chi-squared|||||20.7|-20.5|0.9922
91522426|NCT02638948|182919815|SUPERIORITY||Estimate of Difference (%)|0.1||||1|TWO_SIDED|95.0|-16.0|16.5||Threshold for significance = 0.05|Chi-squared|||||16.5|-16.0|1.0000
91522427|NCT02638948|182919815|SUPERIORITY||Estimate of Difference (%)|5.6||||0.2058|TWO_SIDED|95.0|-10.5|21.9||Threshold for significance = 0.05|Chi-squared|||||21.9|-10.5|0.2058
91522428|NCT02638948|182919815|SUPERIORITY||Estimate of Difference (%)|-0.2||||1|TWO_SIDED|95.0|-22.5|22.2||Threshold for significance = 0.05|Chi-squared|||||22.2|-22.5|1.0000
91522429|NCT04506775|182919845|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.|Mean Error|0.9|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.||||||||
91522430|NCT04506775|182919846|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|Mean Error|0.19|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||
91522431|NCT05007392|182919848|SUPERIORITY||Difference of percentage|35.87|||<|0.001|TWO_SIDED|95.0|27.36|44.37|||Cochran-Mantel-Haenszel|P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.|The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.|||44.37|27.36|<0.001
91522432|NCT05007392|182919849|NON_INFERIORITY|The prespecified non-inferiority margin was -10% in the analysis.|Difference of percentage|5.24|||||TWO_SIDED|95.0|-3.69|14.17|||||The difference of percentage and stratified 95% CI was based on Mantel-Haenszel method.|||14.17|-3.69|
91522433|NCT04058353|182919859|SUPERIORITY||Least Squares (LS) Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.2|4.7|||Mixed-effects model for repeated measure|||||4.7|2.2|<0.0001
91784395|NCT00395343|183449238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.72|-0.4|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction||||-0.40|-0.72|<0.001
91597433|NCT02873936|183086184|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.5|23.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||23.5|6.5|<0.001
91597434|NCT02873936|183086184|SUPERIORITY||Difference in Response Rates|7.6||||0.036|TWO_SIDED|95.0|0.1|15.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||15.2|0.1|0.036
91597435|NCT02873936|183086184|SUPERIORITY||Difference in Response Rates|23.9|||<|0.001|TWO_SIDED|95.0|14.5|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|14.5|<0.001
91597436|NCT02873936|183086184|SUPERIORITY||Difference in Response Rates|12.2||||0.004|TWO_SIDED|95.0|3.7|20.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.6|3.7|0.004
91597437|NCT02873936|183086185|SUPERIORITY||Difference in Response Rates|26.0|||<|0.001|TWO_SIDED|95.0|14.6|37.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||37.4|14.6|<0.001
91597438|NCT02873936|183086185|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|7.5|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||30.0|7.5|<0.001
91597439|NCT02873936|183086185|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.6|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||46.3|23.6|<0.001
91597440|NCT02873936|183086185|SUPERIORITY||Difference in Response Rates|20.4|||<|0.001|TWO_SIDED|95.0|8.8|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||32.1|8.8|<0.001
91597441|NCT02873936|183086186|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.003|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.003
91597442|NCT02873936|183086186|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.027|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.027
91597443|NCT02873936|183086186|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
91597444|NCT02873936|183086186|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
91597445|NCT02873936|183086186|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
91784396|NCT01667419|183449239|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.001|TWO_SIDED|95.0|0.37|0.78|||Log Rank|||||0.78|0.37|0.0010
91784397|NCT01667419|183449239|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2598|TWO_SIDED|95.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.2598
91784398|NCT01667419|183449240|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0133|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||||0.90|0.37|0.0133
91784399|NCT01667419|183449240|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6815|TWO_SIDED|95.0|0.57|1.44|||Log Rank|||||1.44|0.57|0.6815
91784400|NCT01667419|183449241|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0274|TWO_SIDED|95.0|0.3|0.94|||Log Rank|||||.94|0.30|0.0274
91784401|NCT01667419|183449241|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8597|TWO_SIDED|95.0|0.55|1.66|||Log Rank|||||1.66|0.55|0.8597
91790426|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91597446|NCT02873936|183086186|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.006|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.006
91784402|NCT03364270|183449245|OTHER||Mean Difference (Final Values)|0.58||||0.001|TWO_SIDED|95.0|0.33|0.84||Threshold p\<0.05|t-test, 2 sided|||Null hypothesis: There is no difference in mean 18F-RGD uptake (expressed as a target to background ratio) in the culprit artery (carotid artery implicated in stroke or transient ischemic attack \[TIA\]) when compared to mean 18F-RGD uptake in the contralateral carotid artery. A paired t-test was used to compare 18F-RGD uptake in culprit plaque to plaque in the contralateral artery.||0.84|0.33|.001
91597447|NCT02873936|183086187|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|-5.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-5.0|0.008
91597448|NCT02873936|183086187|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.65|TWO_SIDED|95.0|-2.0|1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-2.0|0.65
91597449|NCT02873936|183086187|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
91597450|NCT02873936|183086187|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.008|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|0.008
91597451|NCT02873936|183086187|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
91597452|NCT02873936|183086187|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-4.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-4.0|0.039
91597453|NCT02873936|183086188|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
91597454|NCT02873936|183086188|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-16.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-16.0|<0.001
91597455|NCT02873936|183086188|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-24.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-24.0|<0.001
91613627|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
91784403|NCT03869216|183449247|SUPERIORITY||Mean Difference (Final Values)|0.395|STANDARD_ERROR_OF_MEAN|1.916||0.8388|TWO_SIDED|95.0|-3.4|4.19|||t-test, 2 sided||Intervention - Control|H0:muI = muC||4.19|-3.40|0.8388
91784404|NCT03869216|183449248|SUPERIORITY||Mean Difference (Final Values)|1.781|STANDARD_ERROR_OF_MEAN|2.588||0.4929|TWO_SIDED|95.0|-3.35|6.91|||t-test, 2 sided|||H0:muI = muC||6.91|-3.35|0.4929
91784405|NCT03869216|183449249|SUPERIORITY|Intervention - Control|Mean Difference (Final Values)|-0.735|STANDARD_ERROR_OF_MEAN|0.932||0.4312|TWO_SIDED|95.0|-2.58|1.11|||t-test, 2 sided|||H0:muI = muC||1.11|-2.58|0.4312
91784406|NCT03869216|183449250|SUPERIORITY||Difference in Proportions|-0.1548|STANDARD_ERROR_OF_MEAN|0.087||0.1216|TWO_SIDED|95.0|-0.342|0.033|||t-test, 2 sided|Chi Square Test gives same results|Intervention - Control|H0: piI = piC||0.033|-0.342|0.1216
91784407|NCT03860259|183449290|SUPERIORITY|||||||0.1771||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1771
91784408|NCT03860259|183449290|SUPERIORITY|||||||0.2833||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2833
91784409|NCT03860259|183449290|SUPERIORITY|||||||0.0909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.0909
91784410|NCT03860259|183449290|SUPERIORITY|||||||0.231||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.2310
91597456|NCT02873936|183086188|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
91597457|NCT02873936|183086188|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-25.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-25.0|<0.001
91597458|NCT02873936|183086188|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-19.0|<0.001
91597459|NCT02873936|183086189|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
91597460|NCT02873936|183086189|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-15.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-15.0|<0.001
91597461|NCT02873936|183086189|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-22.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-22.0|<0.001
91597462|NCT02873936|183086189|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-18.0|<0.001
91597463|NCT02873936|183086189|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-18.0|<0.001
91613628|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
91613629|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
91613630|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
91613631|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
91613632|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||<0.001
91784411|NCT03860259|183449290|SUPERIORITY|||||||0.0801|||||||t-test, 1 sided|||120 hrs||||0.0801
91784412|NCT03860259|183449290|SUPERIORITY|||||||0.0307||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Total||||0.0307
91784413|NCT03860259|183449291|SUPERIORITY|||||||0.1956||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1956
91784414|NCT03860259|183449291|SUPERIORITY|||||||0.2274||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2274
91784415|NCT03860259|183449291|SUPERIORITY|||||||0.109||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1090
91784416|NCT03860259|183449291|SUPERIORITY|||||||0.1618||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.1618
91784417|NCT03860259|183449291|SUPERIORITY|||||||0.1264||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.1264
91784418|NCT03860259|183449291|SUPERIORITY|||||||0.0394||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.0394
91784419|NCT03860259|183449291|SUPERIORITY|||||||0.3968||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.3968
91784420|NCT03860259|183449291|SUPERIORITY|||||||0.3407||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.3407
91522434|NCT04058353|182919860|SUPERIORITY||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|95.0|-26.1|-20.1|||Mixed-effects model for repeated measure|||||-20.1|-26.1|<0.0001
91597464|NCT02873936|183086189|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.7||0.052|TWO_SIDED|95.0|-11.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-11.0|0.052
91597465|NCT02873936|183086190|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-21.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-21.0|<0.001
91597466|NCT02873936|183086190|SUPERIORITY||Least Squares Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-19.0|<0.001
91597467|NCT02873936|183086190|SUPERIORITY||Least Squares Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-23.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-23.0|<0.001
91597468|NCT02873936|183086190|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
91597469|NCT02873936|183086190|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-23.0|<0.001
91597470|NCT02873936|183086190|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-19.0|<0.001
91597471|NCT02873936|183086191|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|-0.33|-0.11||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.33|<0.001
91597472|NCT02873936|183086191|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.055||0.006|TWO_SIDED|95.0|-0.26|-0.04||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.26|0.006
91613633|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
91613634|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
91613635|NCT04083222|183121504|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
91613636|NCT04083222|183121504|SUPERIORITY|||||||0.106||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.106
91613637|NCT04083222|183121504|SUPERIORITY|||||||0.318||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.318
91522435|NCT04058353|182919862|SUPERIORITY||LS Mean Difference|8.7|||<|0.0001|TWO_SIDED|95.0|5.3|12.1|||Mixed-effects model for repeated measure|||||12.1|5.3|<0.0001
91784421|NCT03860259|183449291|SUPERIORITY|||||||0.4033||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4033
91597473|NCT02873936|183086191|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.075|<|0.001|TWO_SIDED|95.0|-0.51|-0.21||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.21|-0.51|<0.001
91597474|NCT02873936|183086191|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.075||0.003|TWO_SIDED|95.0|-0.37|-0.08||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.37|0.003
91597475|NCT02873936|183086192|SUPERIORITY||Least Squares Mean Difference|-10.51|STANDARD_ERROR_OF_MEAN|1.578|<|0.001|TWO_SIDED|95.0|-13.61|-7.41||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.41|-13.61|<0.001
91597476|NCT02873936|183086192|SUPERIORITY||Least Squares Mean Difference|-8.92|STANDARD_ERROR_OF_MEAN|1.577|<|0.001|TWO_SIDED|95.0|-12.02|-5.82||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.82|-12.02|<0.001
91597477|NCT02873936|183086192|SUPERIORITY||Least Squares Mean Difference|-10.94|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-14.19|-7.69||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.69|-14.19|<0.001
91597478|NCT02873936|183086192|SUPERIORITY||Least Squares Mean Difference|-8.98|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-12.22|-5.73||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.73|-12.22|<0.001
91597479|NCT02873936|183086192|SUPERIORITY||Least Squares Mean Difference|-9.87|STANDARD_ERROR_OF_MEAN|1.964|<|0.001|TWO_SIDED|95.0|-13.73|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.00|-13.73|<0.001
91597480|NCT02873936|183086192|SUPERIORITY||Least Squares Mean Difference|-6.89|STANDARD_ERROR_OF_MEAN|1.987|<|0.001|TWO_SIDED|95.0|-10.8|-2.98||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.98|-10.80|<0.001
91597481|NCT02873936|183086193|SUPERIORITY||Difference in Response Rates|20.1|||<|0.001|TWO_SIDED|95.0|8.1|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||32.1|8.1|<0.001
91597482|NCT02873936|183086193|SUPERIORITY||Difference in Response Rates|14.5||||0.013|TWO_SIDED|95.0|2.4|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||26.5|2.4|0.013
91597483|NCT02873936|183086193|SUPERIORITY||Difference in Response Rates|22.2|||<|0.001|TWO_SIDED|95.0|10.3|34.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||34.1|10.3|<0.001
91597484|NCT02873936|183086193|SUPERIORITY||Difference in Response Rates|21.8|||<|0.001|TWO_SIDED|95.0|10.0|33.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||33.6|10.0|<0.001
91597485|NCT02873936|183086193|SUPERIORITY||Difference in Response Rates|33.3|||<|0.001|TWO_SIDED|95.0|21.8|44.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||44.9|21.8|<0.001
91597486|NCT02873936|183086193|SUPERIORITY||Difference in Response Rates|18.6||||0.001|TWO_SIDED|95.0|6.8|30.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||30.5|6.8|0.001
91613638|NCT04083222|183121505|SUPERIORITY|||||||0.609||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.609
91613639|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
91784422|NCT03860259|183449292|SUPERIORITY|||||||0.1707||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.1707
91784423|NCT03860259|183449292|SUPERIORITY|||||||0.3446||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3446
91784424|NCT03860259|183449292|SUPERIORITY|||||||0.431|||||||t-test, 1 sided|||48 hrs||||0.4310
91597487|NCT02873936|183086194|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.1|-0.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-1.1|<0.001
91597488|NCT02873936|183086194|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.9|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.9|<0.001
91597489|NCT02873936|183086194|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.5|-0.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.9|-1.5|<0.001
91597490|NCT02873936|183086194|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.3|-0.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.3|<0.001
91597491|NCT02873936|183086194|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.5|<0.001
91597492|NCT02873936|183086194|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-1.1|<0.001
91597493|NCT02873936|183086195|SUPERIORITY||Difference in Response Rates|12.3||||0.004|TWO_SIDED|95.0|3.5|21.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||21.2|3.5|0.004
91597494|NCT02873936|183086195|SUPERIORITY||Difference in Response Rates|12.8||||0.003|TWO_SIDED|95.0|4.0|21.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||21.5|4.0|0.003
91597495|NCT02873936|183086195|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|16.3|38.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.4|16.3|<0.001
91597496|NCT02873936|183086195|SUPERIORITY||Difference in Response Rates|17.0||||0.001|TWO_SIDED|95.0|6.2|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||27.7|6.2|0.001
91597497|NCT02873936|183086196|SUPERIORITY||Difference in Response Rates|7.5||||0.012|TWO_SIDED|95.0|1.3|13.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||13.7|1.3|0.012
91613640|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
91613641|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
91613642|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
91613643|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
91597498|NCT02873936|183086196|SUPERIORITY||Difference in Response Rates|9.1||||0.006|TWO_SIDED|95.0|2.7|15.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||15.5|2.7|0.006
91597499|NCT02873936|183086196|SUPERIORITY||Difference in Response Rates|14.3|||<|0.001|TWO_SIDED|95.0|5.6|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||23.1|5.6|<0.001
91597500|NCT02873936|183086196|SUPERIORITY||Difference in Response Rates|17.4|||<|0.001|TWO_SIDED|95.0|8.5|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||26.2|8.5|<0.001
91597501|NCT02873936|183086199|SUPERIORITY||Least Squares Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-10.0|-4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.2|-10.0|<0.001
91597502|NCT02873936|183086199|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|-7.9|-2.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-7.9|<0.001
91597503|NCT02873936|183086199|SUPERIORITY||Least Squares Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-12.6|-6.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.5|-12.6|<0.001
91597504|NCT02873936|183086199|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-10.6|<0.001
91597505|NCT02873936|183086199|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-11.9|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.9|<0.001
91597506|NCT02873936|183086199|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.66||0.003|TWO_SIDED|95.0|-8.2|-1.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-8.2|0.003
91597507|NCT02873936|183086200|SUPERIORITY||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-11.1|-5.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-11.1|<0.001
91597508|NCT02873936|183086200|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.9|-2.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-8.9|<0.001
91613644|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
91649428|NCT00323609|183191441|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.196
91649429|NCT00323609|183191441|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.281
91597509|NCT02873936|183086200|SUPERIORITY||Least Squares Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.8|-7.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.5|-13.8|<0.001
91597510|NCT02873936|183086200|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-11.8|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.8|<0.001
91597511|NCT02873936|183086200|SUPERIORITY||Least Squares Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.5|-6.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.8|-13.5|<0.001
91597512|NCT02873936|183086200|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-9.4|-2.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-9.4|<0.001
91597513|NCT02873936|183086202|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
91597514|NCT02873936|183086202|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.7||0.005|TWO_SIDED|95.0|0.6|3.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|0.6|0.005
91597515|NCT02873936|183086202|SUPERIORITY||Least Squares Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|1.9|5.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.9|1.9|<0.001
91613645|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
91613646|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
91613647|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
91613648|NCT04083222|183121505|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
91613649|NCT04083222|183121505|SUPERIORITY|||||||0.112||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.112
91613650|NCT04083222|183121505|SUPERIORITY|||||||0.371||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.371
91613651|NCT03103750|183121507|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||The primary hypothesis of calcitriol-related differences in amphetamine-induced dopamine release was determined by significance of the main effect of medication (calcitriol vs. placebo) on %change in BPND (i.e., post-Amp relative to pre-Amp scans) at a threshold of p\<0.05.||||0.016
91613652|NCT03103750|183121509|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91613653|NCT04400318|183121530|SUPERIORITY||Odds Ratio (OR)|9.81|||<|0.001|TWO_SIDED|95.0|3.13|30.82|||Cochran-Mantel-Haenszel|||Odds Ratio, 95% confidence interval (CI) of the odds ratio and p-value between the dupilumab and placebo group based on the Cochran-Mantel-Haenszel (CMH) test adjusted by ICS dose level (medium/high) and region (Eastern Europe/ROW).||30.82|3.13|<0.001
91597516|NCT02873936|183086202|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.002|TWO_SIDED|95.0|1.1|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.1|0.002
91597517|NCT02873936|183086204|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|0.4|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|0.4|0.019
91597518|NCT02873936|183086204|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.97||0.073|TWO_SIDED|95.0|-0.2|3.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.6|-0.2|0.073
91597519|NCT02873936|183086204|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|0.0|4.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|0.0|0.045
91597520|NCT02873936|183086204|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.02||0.32|TWO_SIDED|95.0|-1.0|3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-1.0|0.32
91597521|NCT02873936|183086204|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.19||0.12|TWO_SIDED|95.0|-0.5|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|-0.5|0.12
91597522|NCT02873936|183086204|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.96|TWO_SIDED|95.0|-2.3|2.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.4|-2.3|0.96
91597523|NCT02873936|183086206|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.6|5.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.7|1.6|<0.001
91649430|NCT00323609|183191442|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.033
91649431|NCT00323609|183191442|SUPERIORITY_OR_OTHER|||||||0.981||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.981
91649432|NCT00323609|183191442|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.631
91649433|NCT00323609|183191442|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.790
91597524|NCT02873936|183086206|SUPERIORITY||Least Squares Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED|95.0|1.2|5.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.4|1.2|0.002
91597525|NCT02873936|183086206|SUPERIORITY||Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|2.1|7.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.1|2.1|<0.001
91649434|NCT00323609|183191443|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.663
91597526|NCT02873936|183086206|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-0.5|4.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.7|-0.5|0.11
91597527|NCT02873936|183086209|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.5||0.009|TWO_SIDED|95.0|2.0|11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||11.0|2.0|0.009
91597528|NCT02873936|183086209|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.5||0.003|TWO_SIDED|95.0|3.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|3.0|0.003
91597529|NCT02873936|183086209|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.6||0.003|TWO_SIDED|95.0|3.0|13.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||13.0|3.0|0.003
91597530|NCT02873936|183086209|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.6||0.006|TWO_SIDED|95.0|2.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|2.0|0.006
91597531|NCT02873936|183086209|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.9||0.002|TWO_SIDED|95.0|3.0|15.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||15.0|3.0|0.002
91597532|NCT02873936|183086209|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.9||0.007|TWO_SIDED|95.0|2.0|14.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||14.0|2.0|0.007
91597533|NCT01505634|183086218|NON_INFERIORITY|Non-inferiority for the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-3.1||||0.005|TWO_SIDED|95.0|-11.2|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Difference (Diff) in Favorable MR||3.2|-11.2|0.005
91597534|NCT01505634|183086218|NON_INFERIORITY|Non-inferiority for the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.4|5.9|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Favorable MR||5.9|-6.4|< 0.001
91597535|NCT01505634|183086219|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with Event of Clinical Interest (ECI) #1||5.5|-2.7|0.315
91649435|NCT00323609|183191443|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.933
91649436|NCT00323609|183191443|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.089
91649437|NCT00323609|183191443|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.036
91649438|NCT00323609|183191444|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.472
91597536|NCT01505634|183086219|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #1||5.5|-2.7|0.315
91597537|NCT01505634|183086220|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff Participants with ECI #2||3.8|-3.7|> 0.999
91597538|NCT01505634|183086220|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #2||3.8|-3.7|> 0.999
91597539|NCT01505634|183086221|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.7||||||95.0|-14.3|10.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||10.9|-14.3|
91597540|NCT01505634|183086221|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-0.7|||||TWO_SIDED|95.0|-13.4|12.0|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||12.0|-13.4|
91597541|NCT01505634|183086222|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-5.8|5.9|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||5.9|-5.8|
91597542|NCT01505634|183086222|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-7.6|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||2.8|-7.6|
91597543|NCT01505634|183086223|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-7.5|9.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||9.8|-7.5|
91649439|NCT00323609|183191444|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.745
91597544|NCT01505634|183086223|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.1|||||TWO_SIDED|95.0|-8.4|8.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||8.6|-8.4|
91597545|NCT01505634|183086224|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||4.6|-4.5|
91597546|NCT01505634|183086224|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-5.5|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||2.8|-5.5|
91784425|NCT03860259|183449292|SUPERIORITY|||||||0.3143||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.3143
91597547|NCT01505634|183086225|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-4.4|6.8|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||6.8|-4.4|
91597548|NCT01505634|183086225|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-6.1|3.7|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||3.7|-6.1|
91597549|NCT01505634|183086226|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-3.6|6.2|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||6.2|-3.6|
91597550|NCT01505634|183086226|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||4.6|-4.5|
91649440|NCT00323609|183191444|SUPERIORITY_OR_OTHER|||||||0.565||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.565
91649441|NCT00323609|183191444|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.687
91649442|NCT03803085|183191447|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
91649443|NCT03803085|183191448|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91649444|NCT03803085|183191449|SUPERIORITY|||||||0.06||||||p\<0.05 was considered significant.|Mixed Models Analysis|||||||0.06
91784426|NCT03860259|183449292|SUPERIORITY|||||||0.4749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4749
91784427|NCT03860259|183449292|SUPERIORITY|||||||0.3728||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.3728
91784428|NCT03860259|183449292|SUPERIORITY|||||||0.1628|||||||t-test, 1 sided|||Day 14||||0.1628
91784429|NCT03860259|183449292|SUPERIORITY|||||||0.0731||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.0731
91784430|NCT03860259|183449292|SUPERIORITY|||||||0.4909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.4909
91784431|NCT03860259|183449292|SUPERIORITY|||||||0.4411||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4411
91649445|NCT01154153|183191478|SUPERIORITY_OR_OTHER||Treatment Ratio of Geometric mean|0.966|||||TWO_SIDED|95.0|0.892|1.045|||ANCOVA||The treatment ratio was calculated as an exponential of the mean difference between treatments in log scale.|Missing cortisol values were imputed with multiple imputation. AUC(0-24 hr) was calculated for each imputation and analyzed with log-transformation using an ANCOVA model and analyzed with treatment, sex, and age group as fixed effects, and log-transformed baseline value as a covariate. The mean difference in log scale between treatments and its standard error were calculated by Least Squares mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE.||1.045|0.892|
91649446|NCT01154153|183191479|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.24||0.0007|TWO_SIDED|95.0|-1.34|-0.37|||ANCOVA|For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.||||-0.37|-1.34|0.0007
91649447|NCT01154153|183191480|SUPERIORITY_OR_OTHER|||||||0.1332||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.1332
91649448|NCT01154153|183191481|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3314
91784432|NCT03860259|183449293|SUPERIORITY|||||||0.1786||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Acetaminophen||||0.1786
91649449|NCT03404206|183191537|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91784433|NCT03860259|183449293|SUPERIORITY|||||||0.1876||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Ibuprofen||||0.1876
91597551|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-5.5|7.8|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||7.8|-5.5|
91597552|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||3.6|-8.1|
91597553|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||6.5|-6.4|
91597554|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|2.1|||||TWO_SIDED|95.0|-4.6|9.2|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||9.2|-4.6|
91597555|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||1.9|-9.0|
91597556|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||3.6|-8.1|
91597557|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
91597558|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
91709362|NCT01402986|183311376|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.803|TWO_SIDED|95.0|0.62|1.44|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.44|0.62|0.803
91597559|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|3.1|||||TWO_SIDED|95.0|-3.7|10.4|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||10.4|-3.7|
91649450|NCT03404206|183191537|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91649451|NCT03404206|183191538|SUPERIORITY||Least squares means|-34.73|||||TWO_SIDED|95.0|-45.67|-23.8|||ANCOVA|||||-23.8|-45.67|
91649452|NCT03404206|183191538|SUPERIORITY||Least squares means|-73.43|||||TWO_SIDED|95.0|-89.01|-57.85|||ANCOVA|||||-57.85|-89.01|
91649453|NCT03404206|183191538|SUPERIORITY||Least squares means|-38.7|||||TWO_SIDED|95.0|-54.29|-23.11|||ANCOVA|||||-23.11|-54.29|
91649454|NCT03404206|183191539|SUPERIORITY||Least squares means|-18.21|||||TWO_SIDED|95.0|-23.52|-12.89|||ANCOVA|||||-12.89|-23.52|
91649455|NCT03404206|183191539|SUPERIORITY||Least squares means|-33.72|||||TWO_SIDED|95.0|-41.29|-26.14|||ANCOVA|||||-26.14|-41.29|
91649456|NCT03404206|183191539|SUPERIORITY||Least squares means|-15.51|||||TWO_SIDED|95.0|-23.09|-7.93|||ANCOVA|||||-7.93|-23.09|
91709363|NCT01402986|183311376|SUPERIORITY_OR_OTHER||Rate Ratio|0.83||||0.457|TWO_SIDED|95.0|0.52|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.35|0.52|0.457
91709364|NCT01402986|183311376|SUPERIORITY_OR_OTHER||Rate Ratio|0.71||||0.25|TWO_SIDED|95.0|0.4|1.27|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.27|0.40|0.250
91784434|NCT03860259|183449294|SUPERIORITY|||||||0.3638||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline PCS||||0.3638
91784435|NCT03860259|183449294|SUPERIORITY|||||||0.0856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 PCS||||0.0856
91784436|NCT03860259|183449294|SUPERIORITY|||||||0.4428||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 PCS||||0.4428
91784437|NCT03860259|183449294|SUPERIORITY|||||||0.3378||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 PCS||||0.3378
91784438|NCT03860259|183449294|SUPERIORITY|||||||0.3942||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 PCS||||0.3942
91597560|NCT01505634|183086227|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-7.2|5.1|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||5.1|-7.2|
91597561|NCT02054897|183086234|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.|Treatment difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.25|||Mixed Models Analysis||Semaglutide 1.0 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.25|-1.81|< 0.0001
91597562|NCT02054897|183086234|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.15|||Mixed Models Analysis||Semaglutide 0.5 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.15|-1.71|< 0.0001
91597563|NCT00960843|183086240|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||t-test, 2 sided|||Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.||||0.0520
91784439|NCT03860259|183449294|SUPERIORITY|||||||0.219||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline MCS||||0.2190
91597564|NCT00960843|183086241|SUPERIORITY_OR_OTHER|||||||0.0225||95.0|||||t-test, 2 sided|||||||0.0225
91597565|NCT00960843|183086242|SUPERIORITY_OR_OTHER|||||||0.0193||95.0|||||t-test, 2 sided|||||||0.0193
91649457|NCT05478603|183191540|OTHER||Ratio of adjusted geometric means|94.88|||||TWO_SIDED|90.0|70.86|127.04|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||127.04|70.86|
91784440|NCT03860259|183449294|SUPERIORITY|||||||0.1112||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 MCS||||0.1112
91784441|NCT03860259|183449294|SUPERIORITY|||||||0.1737||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 MCS||||0.1737
91784442|NCT03860259|183449294|SUPERIORITY|||||||0.2408||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 MCS||||0.2408
91597566|NCT00254501|183086243|SUPERIORITY_OR_OTHER|||||||0.0757||||||Adjusted for baseline Hemoglobin A-1C.|ANCOVA|||"Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months."||||0.0757
91597567|NCT00254501|183086244|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||Comparison of change in LDL from baseline to 12 months between groups.||||0.44
91597568|NCT00254501|183086244|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Comparison of change in HDL from baseline to 12 months between groups.||||0.16
91597569|NCT00254501|183086244|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANCOVA|||Comparison of change in total cholesterol from baseline to 12 months between groups.||||0.14
91597570|NCT00254501|183086244|SUPERIORITY_OR_OTHER|||||||0.92|||||||ANCOVA|||Comparison of change in triglycerides from baseline to 12 months between groups.||||0.92
91597571|NCT00254501|183086245|SUPERIORITY_OR_OTHER|||||||0.3856|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.3856
91597572|NCT00254501|183086245|SUPERIORITY_OR_OTHER|||||||0.6413|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.6413
91597573|NCT00254501|183086245|SUPERIORITY_OR_OTHER|||||||0.4303|||||||Wilcoxon (Mann-Whitney)|||Analyses not adjusted for other variables.||||.4303
91784443|NCT03860259|183449294|SUPERIORITY|||||||0.038||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 MCS||||0.0380
91784444|NCT03860259|183449295|SUPERIORITY|||||||0.222||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2220
91784445|NCT03860259|183449296|SUPERIORITY|||||||0.2856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2856
91784446|NCT03860259|183449299|SUPERIORITY|||||||0.2241|||||||t-test, 1 sided|||||||0.2241
91784447|NCT03860259|183449300|SUPERIORITY|||||||0.2714||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.2714
91784448|NCT03860259|183449300|SUPERIORITY|||||||0.3749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3749
91784449|NCT03860259|183449300|SUPERIORITY|||||||0.3862||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.3862
91784450|NCT03860259|183449300|SUPERIORITY|||||||0.1735||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1735
91784451|NCT03860259|183449300|SUPERIORITY|||||||0.4304||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4304
91784452|NCT03860259|183449300|SUPERIORITY|||||||0.4902||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.4902
91784453|NCT03860259|183449300|SUPERIORITY|||||||0.4371||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.4371
91597574|NCT00254501|183086246|SUPERIORITY_OR_OTHER|||||||0.785|||||||ANCOVA|||Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.||||0.785
91784454|NCT03860259|183449300|SUPERIORITY|||||||0.195||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.1950
91784455|NCT03860259|183449300|SUPERIORITY|||||||0.4124|||||||t-test, 1 sided|||Day 60||||0.4124
91784456|NCT03860259|183449300|SUPERIORITY|||||||0.0268||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.0268
91784457|NCT02280408|183449310|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784458|NCT02280408|183449310|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91597575|NCT00254501|183086246|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANCOVA|||Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.||||0.302
91597576|NCT00254501|183086246|SUPERIORITY_OR_OTHER|||||||0.0024|||||||ANCOVA|||Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.||||0.0024
91597577|NCT00879697|183086253|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The effect of training in both groups were assessed by a 2-way ANOVA (Time x Group) for repeated measures. When significance was obtained, the Newman-Keuls post hoc test was used to identify the differences.||||<0.05
91597578|NCT03649061|183086261|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||To compare the two randomization groups, a linear mixed model with DAS28-CRP as outcome (Bell et al. 2014), including random intercepts per patient, adjusted for baseline DAS28-CRP, randomization timepoint, and RF and/or ACPA seropositivity was used.||||<0.05
91649458|NCT05478603|183191540|OTHER||Ratio of adjusted geometric means|99.75|||||TWO_SIDED|90.0|74.5|133.56|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||133.56|74.50|
91784459|NCT02280408|183449310|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91597579|NCT03649061|183086262|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||A binomial generalized linear mixed effect model for repeated measures of remission from randomization up until 28 weeks after was carried out, with adjustment for baseline DAS28-CRP, moment of randomization, and RF and/or ACPA seropositivity.||||<0.05
91597580|NCT01534533|183086300|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|Chi-squared|||"The null hypothesis was no group difference"||||>0.05
91597581|NCT01534533|183086301|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.992
91597582|NCT01534533|183086302|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.672
91597583|NCT01534533|183086303|SUPERIORITY_OR_OTHER|||||||0.402||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.402
91597584|NCT01534533|183086304|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.636
91613654|NCT04400318|183121531|SUPERIORITY||Least square mean difference|21.76|STANDARD_ERROR_OF_MEAN|14.022||0.138|TWO_SIDED|95.0|-7.73|51.25|||MMRM|||The mixed model for repeated measures (MMRM) included study intervention, baseline value, region, ICS dose level, visits, study intervention by visit interaction, and baseline by visit interaction terms all as fixed effects. Region, ICS, study intervention and visits were considered as categorical parameters.||51.25|-7.73|0.138
91784460|NCT02280408|183449310|OTHER|||||||0.01|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.010
91784461|NCT02280408|183449310|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
91784462|NCT02280408|183449310|OTHER|||||||0.969|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.969
91784463|NCT02280408|183449311|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
91784464|NCT02280408|183449311|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
91784465|NCT02280408|183449311|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
91784466|NCT02280408|183449311|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
91784467|NCT02280408|183449311|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
91784468|NCT02280408|183449311|OTHER|||||||0.733|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.733
91784469|NCT02280408|183449312|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784470|NCT02280408|183449312|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784471|NCT02280408|183449312|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784472|NCT02280408|183449312|OTHER|||||||0.132|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.132
91784473|NCT02280408|183449312|OTHER|||||||0.07|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.070
91784474|NCT02280408|183449312|OTHER|||||||0.743|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.743
91784475|NCT02280408|183449313|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784476|NCT02280408|183449313|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784477|NCT02280408|183449313|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
91784478|NCT02280408|183449313|OTHER|||||||0.014|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.014
91784479|NCT02280408|183449313|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
91784480|NCT02280408|183449313|OTHER|||||||0.923|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.923
91597585|NCT00328627|183086313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||For the primary analysis, the overall average HbA1c response of the Alogliptin/pioglitazone combination groups was compared with that of the pioglitazone alone groups at the 2-sided 0.05 significance level with no adjustment for multiple comparisons.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||The null hypothesis was that the doses of alogliptin do not have any additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone. The alternative hypothesis was that at least the higher dose of alogliptin would have an additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone.||-0.41|-0.67|<0.001
91597586|NCT00328627|183086313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||<|0.001|TWO_SIDED|95.0|-0.66|-0.41|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.41|-0.66|<0.001
91597587|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.93|-0.48||As a supportive analysis, each of the individual combination treatment groups was compared with the component treatment groups receiving aloliptin alone and pioglitazone alone at the 2-sided 0.05 significance level with no multiplicity adjustment.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.93|<0.001
91597588|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.81|-0.38|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.38|-0.81|<0.001
91597589|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.15|-0.59|0.001
91597590|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.30|-0.74|<0.001
91597591|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.53|-0.98|<0.001
91597592|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
91597593|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.27|-0.71|<0.001
91597594|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
91597595|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.13|-0.68|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.68|-1.13|<0.001
91597596|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.77|-0.33|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.33|-0.77|<0.001
91597597|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.48|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.92|<0.001
91597598|NCT00328627|183086345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.83|-0.39|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.39|-0.83|<0.001
91597599|NCT00691483|183086485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.03|||<|0.0001|TWO_SIDED|95.0|3.8|9.56||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||9.56|3.80|<0.0001
91597600|NCT00691483|183086486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.45|||<|0.0001|TWO_SIDED|95.0|2.62|7.55||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||7.55|2.62|<0.0001
91649459|NCT05478603|183191540|OTHER||Ratio of adjusted geometric means|68.7|||||TWO_SIDED|90.0|51.31|91.98|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||91.98|51.31|
91597601|NCT00691483|183086487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|2.96|8.13||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.13|2.96|<0.0001
91597602|NCT00691483|183086488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|3.66|8.75||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 12. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.75|3.66|<0.0001
91597603|NCT00691483|183086488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.58|6.58||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 24. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.58|2.58|<0.0001
91597604|NCT00691483|183086489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|95.0|2.58|6.67||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.67|2.58|<0.0001
91597605|NCT04623242|183086491|SUPERIORITY||Ratio|1.063|STANDARD_DEVIATION|0.059|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
91597606|NCT04623242|183086491|SUPERIORITY||Ratio|1.255|STANDARD_DEVIATION|0.061|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
91597607|NCT04623242|183086492|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.094||0.805|TWO_SIDED|95.0|-2.46|1.92|||t-test, 2 sided|||||1.92|-2.46|0.805
91597608|NCT04623242|183086493|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.823||0.512|TWO_SIDED|95.0|-4.83|2.43|||t-test, 2 sided|||Test of equality (any treatment difference)||2.43|-4.83|0.512
91649460|NCT05478603|183191541|OTHER||Ratio of adjusted geometric means|101.87|||||TWO_SIDED|90.0|59.74|173.71|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||173.71|59.74|
91784481|NCT03563183|183449339|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine Group compared to Placebo Group.|Vaccine Efficacy rate|95.81|||<|0.0001|TWO_SIDED|95.0|91.58|98.22|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Non-Frail-HZ/su vs Non-Frail-Placebo groups.||98.22|91.58|<0.0001
91597609|NCT04623242|183086494|OTHER|Test of equality (any treatment difference)|Median Difference (Final Values)|-0.641|STANDARD_ERROR_OF_MEAN|0.1115|<|0.001|TWO_SIDED|95.0|-0.864|-0.417|||t-test, 2 sided|||||-0.417|-0.864|<0.001
91597610|NCT04623242|183086495|OTHER|Test of equality (any difference in the proportion of increase in the endpoint)|Ratio|0.3443||||0.5573|TWO_SIDED||||||Chi-squared|||||||0.5573
91597611|NCT04623242|183086496|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.092||0.707|TWO_SIDED|95.0|-1.77|2.6|||t-test, 2 sided|||||2.60|-1.77|0.707
91597612|NCT04623242|183086497|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.44||0.283|TWO_SIDED|95.0|-1.35|0.4|||t-test, 2 sided|||||0.40|-1.35|0.283
91597613|NCT04623242|183086498|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.859||0.674|TWO_SIDED|95.0|-1.34|2.07|||t-test, 2 sided|||||2.07|-1.34|0.674
91597614|NCT04623242|183086499|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.828||0.507|TWO_SIDED|95.0|-4.86|2.42|||t-test, 2 sided|||||2.42|-4.86|0.507
91597615|NCT04623242|183086500|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|1.706||0.553|TWO_SIDED|95.0|-4.41|2.38|||t-test, 2 sided|||||2.38|-4.41|0.553
91597616|NCT04623242|183086501|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.596||0.098|TWO_SIDED|95.0|-2.18|0.19|||t-test, 2 sided|||||0.19|-2.18|0.098
91597617|NCT04623242|183086502|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.98||0.173|TWO_SIDED|95.0|-1.22|6.68|||t-test, 2 sided|||||6.68|-1.22|0.173
91597618|NCT04623242|183086503|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.998||0.94|TWO_SIDED|95.0|-8.1|8.71|||t-test, 2 sided|||||8.71|-8.10|0.940
91597619|NCT04623242|183086504|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|3.07|STANDARD_ERROR_OF_MEAN|16.524||0.854|TWO_SIDED|95.0|-30.49|36.62|||t-test, 2 sided|||||36.62|-30.49|0.854
91597620|NCT04623242|183086505|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|4.88|STANDARD_ERROR_OF_MEAN|17.448||0.781|TWO_SIDED|95.0|-30.0|39.75|||t-test, 2 sided|||||39.75|-30.00|0.781
91597621|NCT04623242|183086506|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|4.21||0.689|TWO_SIDED|95.0|-10.05|6.67|||t-test, 2 sided|||||6.67|-10.05|0.689
91597622|NCT04623242|183086507|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.689||0.474|TWO_SIDED|95.0|-1.86|0.87|||t-test, 2 sided|||||0.87|-1.86|0.474
91597623|NCT04623242|183086508|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.637||0.886|TWO_SIDED|95.0|-1.36|1.17|||t-test, 2 sided|||||1.17|-1.36|0.886
91597624|NCT04623242|183086509|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.556||0.873|TWO_SIDED|95.0|-1.03|1.2|||t-test, 2 sided|||||1.20|-1.03|0.873
91597625|NCT04623242|183086510|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.66||0.394|TWO_SIDED|95.0|-4.71|1.87|||t-test, 2 sided|||||1.87|-4.71|0.394
91597626|NCT04623242|183086511|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.063||0.776|TWO_SIDED|95.0|-2.41|1.81|||t-test, 2 sided|||||1.81|-2.41|0.776
91597627|NCT04623242|183086512|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.909||0.283|TWO_SIDED|95.0|-2.78|0.82|||t-test, 2 sided|||||0.82|-2.78|0.283
91709365|NCT01402986|183311376|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.794|TWO_SIDED|95.0|0.66|1.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.74|0.66|0.794
91597628|NCT04623242|183086513|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.947||0.634|TWO_SIDED|95.0|-2.33|1.42|||t-test, 2 sided|||||1.42|-2.33|0.634
91597629|NCT04623242|183086514|SUPERIORITY||Ratio|1.155|STANDARD_DEVIATION|0.074|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
91597630|NCT04623242|183086515|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0562||0.726|TWO_SIDED|95.0|-0.093|0.132|||t-test, 2 sided|||||0.132|-0.093|0.726
91597631|NCT04623242|183086516|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.1056||0.439|TWO_SIDED|95.0|-0.13|0.295|||t-test, 2 sided|||||0.295|-0.130|0.439
91597632|NCT04623242|183086517|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.0168||0.967|TWO_SIDED|95.0|-0.034|0.033|||t-test, 2 sided|||||0.033|-0.034|0.967
91597633|NCT04623242|183086518|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0377||0.669|TWO_SIDED|95.0|-0.059|0.092|||t-test, 2 sided|||||0.092|-0.059|0.669
91597634|NCT04623242|183086519|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-34.46|STANDARD_ERROR_OF_MEAN|116.419||0.768|TWO_SIDED|95.0|-264.14|195.22|||t-test, 2 sided|||||195.22|-264.14|0.768
91597635|NCT04623242|183086521|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-2737.62|STANDARD_ERROR_OF_MEAN|6558.467||0.677|TWO_SIDED|95.0|-15678.06|10202.81|||t-test, 2 sided|||||10202.81|-15678.06|0.677
91597636|NCT04623242|183086522|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1078.32|STANDARD_ERROR_OF_MEAN|1788.474||0.547|TWO_SIDED|95.0|-4603.28|2446.64|||t-test, 2 sided|||||2446.64|-4603.28|0.547
91597637|NCT04623242|183086523|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1935.91|STANDARD_ERROR_OF_MEAN|385.538|<|0.001|TWO_SIDED|95.0|-2717.64|-1154.18|||t-test, 2 sided|||||-1154.18|-2717.64|<0.001
91597638|NCT04623242|183086524|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-77.12|STANDARD_ERROR_OF_MEAN|23.014||0.003|TWO_SIDED|95.0|-124.56|-29.68|||t-test, 2 sided|||||-29.68|-124.56|0.003
91597639|NCT04623242|183086525|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|30.89|STANDARD_ERROR_OF_MEAN|35.54||0.388|TWO_SIDED|95.0|-40.04|101.83|||t-test, 2 sided|||||101.83|-40.04|0.388
91597640|NCT04623242|183086526|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|6.624||0.909|TWO_SIDED|95.0|-13.97|12.45|||t-test, 2 sided|||||12.45|-13.97|0.909
91597641|NCT04623242|183086527|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.0593||0.004|TWO_SIDED|95.0|0.059|0.296|||t-test, 2 sided|||||0.296|0.059|0.004
91597642|NCT04623242|183086528|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.355||0.754|TWO_SIDED|95.0|-3.21|2.35|||t-test, 2 sided|||||2.35|-3.21|0.754
91597643|NCT04623242|183086530|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|229362.3|STANDARD_ERROR_OF_MEAN|14863.08|<|0.001|TWO_SIDED|95.0|199264.32|259460.27|||t-test, 2 sided|||||259460.27|199264.32|<0.001
91597644|NCT04623242|183086531|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|32906.6|STANDARD_ERROR_OF_MEAN|1697.541|<|0.001|TWO_SIDED|95.0|29406.49|36406.72|||t-test, 2 sided|||||36406.72|29406.49|<0.001
91597645|NCT04623242|183086532|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|1286.35|STANDARD_ERROR_OF_MEAN|140.692|<|0.001|TWO_SIDED|95.0|1002.79|1569.9|||t-test, 2 sided|||||1569.90|1002.79|<0.001
91597646|NCT04623242|183086533|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|9867.26|STANDARD_ERROR_OF_MEAN|1212.232|<|0.001|TWO_SIDED|95.0|7419.38|12315.15|||t-test, 2 sided|||||12315.15|7419.38|<0.001
91784482|NCT03563183|183449339|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.4|||<|0.0001|TWO_SIDED|95.0|84.41|94.43|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Pre-Frail-HZ/su vs Pre-Frail-Placebo groups.||94.43|84.41|<0.0001
91597647|NCT02921971|183086536|SUPERIORITY||Least square (LS) Mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.21||0.0291|TWO_SIDED|95.0|-4.71|0.08||Above p-value is one-sided p-value. Threshold for significance is at 0.05 level.|Mixed-effect model with repeated measure|||Analysis was performed using mixed model repeated measures (MMRM) model. The model included fixed categorical effects of treatment group, randomization strata as per IVRS, timepoint, treatment-by-timepoint and strata-by-timepoint interactions, as well as the continuous fixed covariate of baseline and baseline-by-timepoint interactions.||0.08|-4.71|0.0291
91597648|NCT01166230|183086562|SUPERIORITY_OR_OTHER|||||||0.141|||||||Fisher Exact|||||||0.141
91597649|NCT01166230|183086563|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.041
91597650|NCT01166230|183086564|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|99.0|||||Wilcoxon (Mann-Whitney)|||||||0.056
91597651|NCT01968460|183086568|SUPERIORITY||Mean Difference (Net)|-4.67|STANDARD_ERROR_OF_MEAN|1.28||0.0004|TWO_SIDED|95.0|-7.2|-2.13||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-2.13|-7.20|0.0004
91597652|NCT01968460|183086568|SUPERIORITY||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|1.25||0.0027|TWO_SIDED|95.0|-6.32|-1.36||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-1.36|-6.32|0.0027
91597653|NCT01968460|183086569|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.51||0.0004|TWO_SIDED|95.0|-2.86|-0.84||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.84|-2.86|0.0004
91597654|NCT01968460|183086569|SUPERIORITY||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|0.01||0.005|TWO_SIDED|95.0|-2.41|0.44||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||0.44|-2.41|0.005
91597655|NCT01968460|183086570|SUPERIORITY||Odds Ratio (OR)|8.1||||0.0165|TWO_SIDED|95.0|1.47|44.77||The overall significance level for this study was 5% using two-tailed tests.|Regression, Logistic|||A subject will be defined as a treatment responder in case that the improvement from baseline to the Week12 / Last Observed Value (LOV) in the CGI-S will be of 1 point or more. Baseline adjusted logistic regression (SAS® LOGISTIC procedure) stratified by GeoSite using the STRATA sub-command with the following effects: treatment group and baseline CGI-S measurement was used to test the between the active groups and placebo contrasts.||44.77|1.47|0.0165
91597656|NCT01968460|183086570|SUPERIORITY||Odds Ratio (OR)|4.23|STANDARD_ERROR_OF_MEAN|0.9||0.111|TWO_SIDED|95.0|0.72|24.9||The overall significance level for this study will be 5% using two-tailed tests.|Regression, Logistic|||||24.90|0.72|0.111
91784483|NCT03563183|183449339|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.17|||<|0.0001|TWO_SIDED|95.0|75.36|96.65|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Frail-HZ/su vs Frail-Placebo groups.||96.65|75.36|<0.0001
91784484|NCT03563183|183449339|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|100.0||||0.069|TWO_SIDED|95.0|14.61|100.0|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Unknown-HZ/su vs Unknown-Placebo groups.||100|14.61|0.069
91784485|NCT03563183|183449340|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|98.6|||||TWO_SIDED|95.0|97.1|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|97.1|
91784486|NCT03563183|183449340|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|92.6|||||TWO_SIDED|95.0|86.6|98.7||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||98.7|86.6|
91784487|NCT03563183|183449340|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|85.2|||||TWO_SIDED|95.0|62.6|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|62.6|
91649461|NCT05478603|183191541|OTHER||Ratio of adjusted geometric means|156.07|||||TWO_SIDED|90.0|91.53|266.14|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||266.14|91.53|
91649462|NCT05478603|183191541|OTHER||Ratio of adjusted geometric means|96.48|||||TWO_SIDED|90.0|56.58|164.51|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||164.51|56.58|
91649463|NCT05478603|183191542|OTHER||Ratio of adjusted geometric means|102.21|||||TWO_SIDED|90.0|59.91|174.39|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||174.39|59.91|
91649464|NCT05478603|183191542|OTHER||Ratio of adjusted geometric means|152.91|||||TWO_SIDED|90.0|89.62|260.9|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||260.90|89.62|
91649465|NCT05478603|183191542|OTHER||Ratio of adjusted geometric means|97.08|||||TWO_SIDED|90.0|56.9|165.65|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||165.65|56.90|
91649466|NCT05478603|183191543|OTHER||Ratio of adjusted geometric means|93.29|||||TWO_SIDED|90.0|64.61|134.69|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||134.69|64.61|
91649467|NCT05478603|183191543|OTHER||Ratio of adjusted geometric means|106.68|||||TWO_SIDED|90.0|73.89|154.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||154.03|73.89|
91649468|NCT05478603|183191543|OTHER||Ratio of adjusted geometric means|246.28|||||TWO_SIDED|90.0|170.57|355.58|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||355.58|170.57|
91649469|NCT05478603|183191544|OTHER||Ratio of adjusted geometric means|88.5|||||TWO_SIDED|90.0|64.13|122.12|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||122.12|64.13|
91597657|NCT01968460|183086571|SUPERIORITY||Mean Difference (Net)|-2.81|STANDARD_ERROR_OF_MEAN|1.0||0.0058|TWO_SIDED|95.0|-4.8|-0.83||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.83|-4.80|0.0058
91597658|NCT01968460|183086571|SUPERIORITY||Mean Difference (Net)|-2.32|STANDARD_ERROR_OF_MEAN|0.98||0.0191|TWO_SIDED|95.0|-4.26|-0.39||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.39|-4.26|0.0191
91597659|NCT01968460|183086572|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.24||0.0097|TWO_SIDED|95.0|-5.72|-0.8||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.80|-5.72|0.0097
91597660|NCT01968460|183086572|SUPERIORITY||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|1.24||0.0509|TWO_SIDED|95.0|-4.91|-0.012||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.012|-4.91|0.0509
91597661|NCT02597855|183086575|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||The difference of polyp regression rate between two groups were compared.||||<0.05
91597662|NCT02597855|183086576|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney test was used for a comparison of best corrected visual acuity assessed at baseline, 3 months, and 6 months between type1 and type2.||best corrected visual acuity was compared between two groups||||<0.05
91597663|NCT04283123|183086607|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.41|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
91597664|NCT04283123|183086607|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.45|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
91597665|NCT04283123|183086608|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.48|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
91597666|NCT04283123|183086608|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.32|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
91597667|NCT04283123|183086609|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.6|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
91597668|NCT04283123|183086609|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.12|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
91597669|NCT01485627|183086626|SUPERIORITY||Adjusted mean difference in difference|0.34||||0.05|TWO_SIDED|95.0|0.06|0.62|||Mixed Models Analysis||Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase\*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.|The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding \[APPC\], Verona VR-CoDES, Prognostic and Treatment Choices \[PTCC\] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.||0.62|0.06|0.05
91597670|NCT01485627|183086627|SUPERIORITY|||||||0.214|||||||Mixed Models Analysis|||||||0.214
91597671|NCT01485627|183086628|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.56|0.37|||Mixed Models Analysis|||||0.37|-0.56|0.05
91597672|NCT01485627|183086630|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
91597673|NCT01485627|183086631|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
91597674|NCT04749459|183086632|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Classic: CIs +/- 13.7% P2 Control Standard (vs. CSM Classic) CIs +/- 16.4%|||
91597675|NCT04749459|183086632|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Strawberry Flavor: CIs +/- 16.6% P2 Control Standard (vs CSM Strawberry Flavour): CIs +/- 16.0%|||
91597676|NCT00267748|183086633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.089||||0.86|TWO_SIDED|95.0|0.423|2.803|||Log Rank|||For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.803|0.423|0.860
91597677|NCT00267748|183086633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.583|TWO_SIDED|95.0|0.623|1.306|||Log Rank|||For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.306|0.623|0.583
91597678|NCT00267748|183086633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.556||||0.075|TWO_SIDED|95.0|0.288|1.074|||Log Rank|||For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.074|0.288|0.075
91597679|NCT00267748|183086633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.22|TWO_SIDED|95.0|0.609|1.124|||Log Rank|||For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.124|0.609|0.220
91597680|NCT00267748|183086633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.09|TWO_SIDED|95.0|0.572|1.044|||Log Rank|||For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.||1.044|0.572|0.090
91784488|NCT03563183|183449340|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|100.0||||||||||||||VE against the BOI due to confirmed HZ. The 95% Confidence Interval was not calculated as there were no subjects reported with a confirmed Zoster episode in the Unknown-HZ/su Group.||||
91784489|NCT01015638|183449372|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
91597681|NCT00267748|183086634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.11||||0.444|TWO_SIDED|95.0|-6.4|14.6|||Chi-squared|||Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.||14.6|-6.4|0.444
91597682|NCT00267748|183086636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.071||||0.866|TWO_SIDED|95.0|0.481|2.387|||Log Rank|||For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.387|0.481|0.866
91597683|NCT00267748|183086636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.169||||0.439|TWO_SIDED|95.0|0.785|1.741|||Log Rank|||For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.741|0.785|0.439
91597684|NCT00267748|183086636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.238||||0.614|TWO_SIDED|95.0|0.538|2.851|||Log Rank|||For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.851|0.538|0.614
91597685|NCT00267748|183086636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.365|TWO_SIDED|95.0|0.838|1.612|||Log Rank|||For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.612|0.838|0.365
91597686|NCT00267748|183086637|SUPERIORITY_OR_OTHER|||||||0.6737|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.6737
91597687|NCT00267748|183086638|SUPERIORITY_OR_OTHER|||||||0.1967|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.1967
91597688|NCT00004259|183086649|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.36|TWO_SIDED|95.0|0.67|1.32|||Log Rank|||The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.||1.32|0.67|0.36
91597689|NCT00004259|183086651|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.46|TWO_SIDED|95.0|0.55|1.16||2-sided|Gray's test||Reference level = RT + BCNU/CCNU|||1.16|0.55|0.46
91649470|NCT05478603|183191544|OTHER||Ratio of adjusted geometric means|106.4|||||TWO_SIDED|90.0|77.11|146.83|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||146.83|77.11|
91597690|NCT00004259|183086652|SUPERIORITY||||||<|0.001||||||2-sided|Chi-squared|||Overall toxicity||||<0.001
91597691|NCT00004259|183086652|SUPERIORITY|||||||0.76||||||2-sided|Chi-squared|||Non-hematologic toxicity||||0.76
91784490|NCT01015638|183449373|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||>0.05
91597692|NCT00004259|183086653|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.08|TWO_SIDED|95.0|0.93|3.4|||Log Rank|Two-side significance level = 0.05|Reference level = Methylated MGMT|||3.40|0.93|0.08
91597693|NCT00004259|183086654|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.41|TWO_SIDED|95.0|0.7|2.35|||Log Rank|Two-sided confidence interval = 0.5|Reference level = Methylated|||2.35|0.70|0.41
91597694|NCT03594227|183086655|SUPERIORITY||Mean Difference (Net)|-19.26|STANDARD_ERROR_OF_MEAN|5.02||0.011|TWO_SIDED|95.0|-33.98|-4.54||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.54|-33.98|0.011
91784491|NCT01015638|183449374|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
91784492|NCT01015638|183449375|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Tukey-Kramer Multiple Comparisons Test|||||||> 0.05
91784493|NCT06011759|183449409|SUPERIORITY|T-test to evaluate the effect of the intervention compared to control sites on reported suicide behavior events in the past 4 quarters that had an SP 2.0 Consult submitted.||||||0.5747|||||||t-test, 2 sided|degrees of freedom = 6||We compared participating sites with similar non-participating sites. Four non-participating sites were selected as matched controls, one for each participating site. Control sites were matched to participating sites on number of suicide behavior events and prevalence of Suicide Prevention Telehealth Program consults submitted at baseline.||||0.5747
91784494|NCT06011759|183449410|SUPERIORITY|T-test to evaluate the effect of the intervention compared to control sites on referrals to the SP 2.0 Clinic.||||||0.8057|||||||t-test, 2 sided|Degrees of freedom = 6||We compared participating sites with similar non-participating sites. Four non-participating sites were selected as matched controls, one for each participating site. Control sites were matched to participating sites on number of suicide behavior events and prevalence of Suicide Prevention Telehealth Program consults submitted at baseline.||||0.8057
91597695|NCT03594227|183086655|SUPERIORITY||Mean Difference (Final Values)|-24.08|STANDARD_ERROR_OF_MEAN|5.02||0.001|TWO_SIDED|95.0|-38.8|-9.36||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-9.36|-38.80|0.001
91597696|NCT03594227|183086655|SUPERIORITY||Mean Difference (Final Values)|-19.54|STANDARD_ERROR_OF_MEAN|5.133||0.01|TWO_SIDED|95.0|-34.41|-4.67||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.67|-34.41|0.010
91597697|NCT03594227|183086656|SUPERIORITY||Mean Difference (Final Values)|-19.17|STANDARD_ERROR_OF_MEAN|5.165||0.013|TWO_SIDED|95.0|-34.33|-4.02|||Mixed Models Analysis|||||-4.02|-34.33|0.013
91597698|NCT03594227|183086656|SUPERIORITY||Mean Difference (Net)|-24.53|STANDARD_ERROR_OF_MEAN|5.165||0.002|TWO_SIDED|95.0|-39.69|-9.38|||Mixed Models Analysis|||||-9.38|-39.69|0.002
91597699|NCT03594227|183086656|SUPERIORITY||Mean Difference (Net)|-19.17|STANDARD_ERROR_OF_MEAN|5.281||0.014|TWO_SIDED|95.0|-34.48|-3.86|||Mixed Models Analysis|||||-3.86|-34.48|0.014
91649471|NCT05478603|183191544|OTHER||Ratio of adjusted geometric means|169.19|||||TWO_SIDED|90.0|122.61|233.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||233.47|122.61|
91784495|NCT05487196|183449417|NON_INFERIORITY|The noninferiority margin δ was set as the median of fentanyl group + 30 representing a 1-point pain numeric rating scale difference per unit time across the 30-minute initiation period. A conventional 1-sided 95% confidence interval (CI) was constructed using normal distribution assumptions. Analysis was by intent to treat. Comparisons of PI-AUC30 between the three agents were made by one-way ANOVA.||||||0.226|||||||ANOVA|||||||0.226
91597700|NCT03594227|183086657|SUPERIORITY||Mean Difference (Net)|-11.29|STANDARD_ERROR_OF_MEAN|3.359||0.025|TWO_SIDED|95.0|-21.14|-1.45|||Mixed Models Analysis|||||-1.45|-21.14|0.025
91597701|NCT03594227|183086657|SUPERIORITY||Mean Difference (Net)|-15.25|STANDARD_ERROR_OF_MEAN|3.359||0.003|TWO_SIDED|95.0|-25.1|-5.4|||Mixed Models Analysis|||||-5.40|-25.10|0.003
91597702|NCT03594227|183086657|SUPERIORITY||Mean Difference (Net)|-17.55|STANDARD_ERROR_OF_MEAN|3.434|<|0.001|TWO_SIDED|95.0|-27.49|-7.6|||Mixed Models Analysis|||||-7.60|-27.49|<0.001
91597703|NCT03594227|183086658|SUPERIORITY||Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|3.599||0.008|TWO_SIDED|95.0|-24.95|-3.84|||Mixed Models Analysis|||||-3.84|-24.95|0.008
91597704|NCT03594227|183086658|SUPERIORITY||Mean Difference (Net)|-19.01|STANDARD_ERROR_OF_MEAN|3.599|<|0.001|TWO_SIDED|95.0|-29.56|-8.45|||Mixed Models Analysis|||||-8.45|-29.56|<0.001
91597705|NCT03594227|183086658|SUPERIORITY||Mean Difference (Net)|-17.52|STANDARD_ERROR_OF_MEAN|3.679||0.001|TWO_SIDED|95.0|-28.18|-6.86|||Mixed Models Analysis|||||-6.86|-28.18|0.001
91597706|NCT03594227|183086659|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
91597707|NCT03594227|183086659|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
91597708|NCT03594227|183086659|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
91597709|NCT03594227|183086660|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
91597710|NCT03594227|183086660|SUPERIORITY||Odds Ratio (OR)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
91597711|NCT03594227|183086660|SUPERIORITY||Odds Ratio (OR)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
91597712|NCT03594227|183086661|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
91597713|NCT03594227|183086661|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
91597714|NCT03594227|183086661|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|||||||0.367
91597715|NCT03594227|183086662|SUPERIORITY|||||||0.187|||||||Wilcoxon (Mann-Whitney)|||||||0.187
91597716|NCT03594227|183086662|SUPERIORITY|||||||0.375|||||||Wilcoxon (Mann-Whitney)|||||||0.375
91597717|NCT03594227|183086662|SUPERIORITY|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
91597718|NCT03594227|183086663|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||||||0.444
91597719|NCT03594227|183086663|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
91597720|NCT03594227|183086663|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
91597721|NCT03594227|183086664|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
91597722|NCT03594227|183086664|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
91597723|NCT03594227|183086664|SUPERIORITY|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||||||0.101
91597724|NCT03594227|183086665|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
91597725|NCT03594227|183086665|SUPERIORITY|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
91597726|NCT03594227|183086665|SUPERIORITY|||||||0.159|||||||Wilcoxon (Mann-Whitney)|||||||0.159
91597727|NCT03594227|183086666|SUPERIORITY|||||||0.407|||||||Wilcoxon (Mann-Whitney)|||||||0.407
91597728|NCT03594227|183086666|SUPERIORITY|||||||0.894|||||||Wilcoxon (Mann-Whitney)|||||||0.894
91597729|NCT03594227|183086666|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||||||0.179
91597730|NCT03594227|183086667|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
91597731|NCT03594227|183086667|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
91784496|NCT05487196|183449418|SUPERIORITY|||||||0.16|||||||ANOVA|||||||0.16
91784497|NCT05487196|183449419|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
91784498|NCT05487196|183449420|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
91784499|NCT05487196|183449421|SUPERIORITY|||||||0.22|||||||ANOVA|||||||0.22
91597732|NCT03594227|183086667|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
91597733|NCT03594227|183086668|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91597734|NCT03594227|183086668|SUPERIORITY|||||||0.154|||||||Wilcoxon (Mann-Whitney)|||||||0.154
91597735|NCT03594227|183086668|SUPERIORITY|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
91597736|NCT03594227|183086669|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
91649472|NCT05478603|183191545|OTHER||Ratio of adjusted geometric means|95.12|||||TWO_SIDED|90.0|52.6|172.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.03|52.60|
91597737|NCT03594227|183086669|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.660
91597738|NCT03594227|183086669|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|||||||0.704
91597739|NCT03594227|183086670|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
91597740|NCT03594227|183086670|SUPERIORITY|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||||||0.911
91597741|NCT03594227|183086670|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
91597742|NCT03594227|183086671|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.430
91597743|NCT03594227|183086671|SUPERIORITY|||||||0.288|||||||Wilcoxon (Mann-Whitney)|||||||0.288
91597744|NCT03594227|183086671|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
91597745|NCT03594227|183086672|SUPERIORITY|||||||0.194|||||||Wilcoxon (Mann-Whitney)|||||||0.194
91597746|NCT03594227|183086672|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
91597747|NCT03594227|183086672|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91597748|NCT03594227|183086673|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||||||0.248
91597749|NCT03594227|183086673|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.150
91597750|NCT03594227|183086673|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
91597751|NCT03594227|183086674|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
91597752|NCT03594227|183086674|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
91597753|NCT03594227|183086674|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
91597754|NCT03594227|183086676|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
91597755|NCT03594227|183086676|SUPERIORITY|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
91597756|NCT03594227|183086676|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
91597757|NCT03594227|183086677|SUPERIORITY|||||||0.883|||||||Wilcoxon (Mann-Whitney)|||||||0.883
91597758|NCT03594227|183086677|SUPERIORITY|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||||||0.954
91597759|NCT03594227|183086677|SUPERIORITY|||||||0.295|||||||Wilcoxon (Mann-Whitney)|||||||0.295
91597760|NCT03594227|183086678|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
91597761|NCT03594227|183086678|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
91597762|NCT03594227|183086678|SUPERIORITY|||||||0.815|||||||Wilcoxon (Mann-Whitney)|||||||0.815
91597763|NCT03594227|183086679|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||||||0.522
91597764|NCT03594227|183086679|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
91597765|NCT03594227|183086679|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
91597766|NCT03594227|183086680|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.93||0.882|TWO_SIDED|95.0|-2.53|2.94|||Mixed Models Analysis|||||2.94|-2.53|0.882
91597767|NCT03594227|183086680|SUPERIORITY||Mean Difference (Net)|-3.58|STANDARD_ERROR_OF_MEAN|0.93||0.011|TWO_SIDED|95.0|-6.31|-0.84|||Mixed Models Analysis|||||-0.84|-6.31|0.011
91597768|NCT03594227|183086680|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.951||0.999|TWO_SIDED|95.0|-2.76|2.76|||Mixed Models Analysis|||||2.76|-2.76|0.999
91597769|NCT03594227|183086681|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
91597770|NCT03594227|183086681|SUPERIORITY|||||||0.319|||||||Wilcoxon (Mann-Whitney)|||||||0.319
91597771|NCT03594227|183086681|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
91597772|NCT03594227|183086682|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||||||0.584
91597773|NCT03594227|183086682|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
91597774|NCT03594227|183086682|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
91597775|NCT03594227|183086683|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
91597776|NCT03594227|183086683|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
91597777|NCT03594227|183086683|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
91597778|NCT03594227|183086684|SUPERIORITY|||||||0.827|||||||Wilcoxon (Mann-Whitney)|||||||0.827
91597779|NCT03594227|183086684|SUPERIORITY|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
91597780|NCT03594227|183086684|SUPERIORITY|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
91597781|NCT03594227|183086685|SUPERIORITY|||||||0.836|||||||Wilcoxon (Mann-Whitney)|||||||0.836
91597782|NCT03594227|183086685|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.540
91597783|NCT03594227|183086685|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
91597784|NCT03594227|183086686|SUPERIORITY|||||||0.469|||||||Wilcoxon (Mann-Whitney)|||||||0.469
91784500|NCT05487196|183449422|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
91597785|NCT03594227|183086686|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||||||0.219
91597786|NCT03594227|183086686|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
91597787|NCT03389854|183086691|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
91597788|NCT03389854|183086691|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.90
91597789|NCT03389854|183086692|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
91597790|NCT03389854|183086692|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.40
91597791|NCT03389854|183086693|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.01
91597792|NCT03389854|183086693|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.64
91597793|NCT03389854|183086694|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.06
91597794|NCT03389854|183086694|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.66
91597795|NCT03389854|183086695|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
91597796|NCT03389854|183086696|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91597797|NCT03389854|183086697|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91597798|NCT01618214|183086708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%.|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||||95.0|-0.19|0.14|||Regression, Linear|||FAS||0.14|-0.19|
91597799|NCT02500628|183086731|OTHER|||||||0.77|||||||t-test, 2 sided|||comparison between fibromyalgia and non-fibromyalgia group||||0.77
91597800|NCT02500628|183086732|OTHER|||||||0.27|||||||t-test, 2 sided|||||||0.27
91597801|NCT02500628|183086733|OTHER|||||||0.92|||||||t-test, 2 sided|||difference between fibromyalgia and non-fibromyalgia patients.||||0.92
91597802|NCT02111993|183086746|SUPERIORITY_OR_OTHER|||||||0.02||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.02
91597803|NCT02111993|183086746|SUPERIORITY_OR_OTHER|||||||0.03||||||This p-value correlates to Δ8 hr cTnT.|t-test, 2 sided|||||||0.03
91597804|NCT02111993|183086746|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
91597805|NCT02111993|183086747|SUPERIORITY_OR_OTHER|||||||0.04||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.04
91597806|NCT02111993|183086747|SUPERIORITY_OR_OTHER|||||||0.06||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.06
91597807|NCT02111993|183086747|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
91597808|NCT02111993|183086748|SUPERIORITY_OR_OTHER|||||||0.17||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.17
91597809|NCT02111993|183086748|SUPERIORITY_OR_OTHER|||||||0.19||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.19
91597810|NCT02111993|183086748|SUPERIORITY_OR_OTHER|||||||0.38||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.38
91597811|NCT04074928|183086753|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.645|0.836||||||"Non-inferiority, A/H1N1, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H1N1 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.836|0.645|
91597812|NCT04074928|183086753|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.656|0.809||||||"Non-inferiority, B/Yamagata, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Yamagata vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.809|0.656|
91597813|NCT04074928|183086753|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.88|||||TWO_SIDED|95.0|0.791|0.972||||||"Non-inferiority, B/Victoria, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Victoria vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.972|0.791|
91597814|NCT04074928|183086754|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-11.46|||||TWO_SIDED|95.0|-16.447|-6.423||||||"Non-inferiority, A/H1N1, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H1N1 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-6.423|-16.447|
91784501|NCT05487196|183449423|SUPERIORITY|||||||0.83|||||||Fisher Exact|||||||0.83
91784502|NCT05487196|183449424|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
91784503|NCT05487196|183449425|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
91784504|NCT05487196|183449426|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
91784505|NCT05487196|183449427|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
91784506|NCT05487196|183449428|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
91784507|NCT05487196|183449429|SUPERIORITY|||||||0.98|||||||Kruskal-Wallis|||||||0.98
91790427|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.079||0.688|TWO_SIDED|95.0|-0.188|0.124||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.124|-0.188|0.688
91597815|NCT04074928|183086754|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-14.87|||||TWO_SIDED|95.0|-19.61|-9.983||||||"Non-inferiority, B/Yamagata, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Yamagata vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-9.983|-19.610|
91597816|NCT04074928|183086754|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-5.96|||||TWO_SIDED|95.0|-10.327|-1.44||||||"Non-inferiority, B/Victoria, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Victoria vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-1.440|-10.327|
91597817|NCT04074928|183086755|NON_INFERIORITY|The noninferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified noninferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|1.04|||||TWO_SIDED|95.0|0.927|1.16||||||"Non-inferiority, A/H3N2, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H3N2 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||1.160|0.927|
91597818|NCT04074928|183086756|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|3.13|||||TWO_SIDED|95.0|-1.443|7.812||||||"Non-inferiority, A/H3N2, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H3N2 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||7.812|-1.443|
91597819|NCT04074928|183086757|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.024||||||A/H1N1, GMT ratio, Day 29/57||1.024|0.790|
91597820|NCT04074928|183086757|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.08|||||TWO_SIDED|95.0|0.968|1.195||||||B/Yamagata, GMT ratio, Day 29/57||1.195|0.968|
91790428|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790429|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.081||0.137|TWO_SIDED|95.0|-0.039|0.281||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.281|-0.039|0.137
91790430|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790431|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.107||0.408|TWO_SIDED|95.0|-0.3|0.122||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.122|-0.300|0.408
91790432|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790433|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.104||0.249|TWO_SIDED|95.0|-0.325|0.085||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.085|-0.325|0.249
91790434|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790435|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.616|TWO_SIDED|95.0|-0.265|0.157||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.157|-0.265|0.616
91790436|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790437|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.119||0.555|TWO_SIDED|95.0|-0.163|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.304|-0.163|0.555
91790438|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790439|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117||0.815|TWO_SIDED|95.0|-0.203|0.258||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.258|-0.203|0.815
91790440|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790441|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.119||0.138|TWO_SIDED|95.0|-0.057|0.409||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.409|-0.057|0.138
91597821|NCT04074928|183086757|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.986|1.202||||||B/Victoria, GMT ratio, Day 29/57||1.202|0.986|
91597822|NCT04074928|183086758|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-2.52|||||TWO_SIDED|95.0|-7.526|2.461||||||A/H1N1, SCR difference, Day 29/57||2.461|-7.526|
91597823|NCT04074928|183086758|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-0.04|||||TWO_SIDED|95.0|-4.912|4.911||||||B/Yamagata, SCR difference, Day 29/57||4.911|-4.912|
91597824|NCT04074928|183086758|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.18|||||TWO_SIDED|95.0|-2.805|5.353||||||B/Victoria, SCR difference, Day 29/57||5.353|-2.805|
91597825|NCT04074928|183086759|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.914|1.165||||||A/H3N2, GMT ratio, Day 29/57||1.165|0.914|
91597826|NCT04074928|183086760|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.89|||||TWO_SIDED|95.0|-3.006|6.856||||||A/H3N2, SCR difference, Day 29/57||6.856|-3.006|
91597827|NCT00610987|183086773|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||t-test, 1 sided|||||||=0.12
91597828|NCT04249687|183086789|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
91597829|NCT04249687|183086790|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
91597830|NCT01508702|183086791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.37|||Cochran-Mantel-Haenszel|||||0.37|0.19|<0.0001
91597831|NCT04472429|183086792|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0006|TWO_SIDED|95.0|0.47|0.84||tested at the 1-sided 2.5% level|stratified log-rank test||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.84|0.47|0.0006
91597832|NCT01180660|183086805|SUPERIORITY_OR_OTHER||Median Difference (Net)|19.0||||0.01|TWO_SIDED|95.0|3.0|27.0|||Regression, Linear|||A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.||27|3|.01
91597833|NCT03461757|183086813|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.0001|TWO_SIDED|95.0|6.5|14.2|||Cochran-Mantel-Haenszel|||||14.2|6.5|< 0.0001
91597834|NCT03461757|183086814|SUPERIORITY||Risk Difference (RD)|8.3||||0.0009|TWO_SIDED|95.0|3.4|13.2|||Cochran-Mantel-Haenszel|||||13.2|3.4|0.0009
91597835|NCT03461757|183086815|SUPERIORITY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.8|21.3|||Cochran-Mantel-Haenszel|||||21.3|10.8|< 0.0001
91597836|NCT03461757|183086816|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
91597837|NCT03461757|183086817|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
91597838|NCT03461757|183086818|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.0001|TWO_SIDED|95.0|4.9|13.7|||Cochran-Mantel-Haenszel|||||13.7|4.9|< 0.0001
91597839|NCT03461757|183086819|SUPERIORITY||Risk Difference (RD)|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.3|-10.7|||Cochran-Mantel-Haenszel|||||-10.7|-19.3|< 0.0001
91597840|NCT03461757|183086820|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.0001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|||||17.2|8.3|< 0.0001
91597841|NCT03461757|183086821|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|12.0|21.9|||Cochran-Mantel-Haenszel|||||21.9|12.0|< 0.0001
91597842|NCT03461757|183086822|SUPERIORITY||Risk Difference (RD)|6.8||||0.0018|TWO_SIDED|95.0|2.5|11.0|||Cochran-Mantel-Haenszel|||||11.0|2.5|0.0018
91597843|NCT03461757|183086823|SUPERIORITY||Risk Difference (RD)|10.6|||<|0.0001|TWO_SIDED|95.0|6.3|14.9|||Cochran-Mantel-Haenszel|||||14.9|6.3|< 0.0001
91597844|NCT03461757|183086824|SUPERIORITY||Risk Difference (RD)|8.8||||0.0007|TWO_SIDED|95.0|3.7|13.9|||Cochran-Mantel-Haenszel|||||13.9|3.7|0.0007
91597845|NCT03461757|183086825|SUPERIORITY||Risk Difference (RD)|8.9||||0.0002|TWO_SIDED|95.0|4.3|13.6|||Cochran-Mantel-Haenszel|||||13.6|4.3|0.0002
91597846|NCT03461757|183086826|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|7.1|17.6|||Cochran-Mantel-Haenszel|||||17.6|7.1|< 0.0001
91709366|NCT01402986|183311377|SUPERIORITY_OR_OTHER||Rate Ratio|1.2||||0.614|TWO_SIDED|95.0|0.59|2.46|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.46|0.59|0.614
91597847|NCT03461757|183086827|SUPERIORITY||Risk Difference (RD)|10.1|||<|0.0001|TWO_SIDED|95.0|6.9|13.4|||Cochran-Mantel-Haenszel|||||13.4|6.9|< 0.0001
91597848|NCT03461757|183086828|SUPERIORITY||Risk Difference (RD)|5.8||||0.0128|TWO_SIDED|95.0|1.2|10.4|||Cochran-Mantel-Haenszel|||||10.4|1.2|0.0128
91597849|NCT03461757|183086829|SUPERIORITY||Risk Difference (RD)|7.8|||<|0.0001|TWO_SIDED|95.0|4.4|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.4|< 0.0001
91597850|NCT03461757|183086830|SUPERIORITY||Risk Difference (RD)|11.5||||0.0003|TWO_SIDED|95.0|5.3|17.7|||Cochran-Mantel-Haenszel|||||17.7|5.3|0.0003
91597851|NCT03461757|183086831|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.0001|TWO_SIDED|95.0|4.9|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.9|< 0.0001
91597852|NCT03461757|183086832|SUPERIORITY||Risk Difference (RD)|5.5||||0.0314|TWO_SIDED|95.0|0.5|10.6|||Cochran-Mantel-Haenszel|||||10.6|0.5|0.0314
91597853|NCT03461757|183086833|SUPERIORITY||Risk Difference (RD)|6.4||||0.0025|TWO_SIDED|95.0|2.3|10.6|||Cochran-Mantel-Haenszel|||||10.6|2.3|0.0025
91597854|NCT03461757|183086834|SUPERIORITY||Risk Difference (RD)|5.9||||0.0898|TWO_SIDED|95.0|-0.9|12.7||P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.7|-0.9|0.0898
91784508|NCT05188053|183449430|OTHER|"Sample size calculations were performed to estimate the number of subjects needed to detect a 30% difference in NRS pain AUC scores between the study groups.~30% reduction in pain was considered the minimal clinically important difference in pain control based off previous pain research.~A 30% reduction in pain would correspond with a difference of approximately 136 in area under the curve of mean pain over time."||||||0.17||||||a priori threshold p \<0.05|t-test, 2 sided|assuming unequal variance||Two-sample t-test with unequal variance. The null hypothesis is that there was no statistically significant difference between the two treatment groups based on a standard alpha value of 0.05.||||0.170
91784509|NCT05126225|183449456|OTHER|Single group|Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.224||0.05|TWO_SIDED|95.0|0.032|0.96|||t-test, 2 sided|||||0.960|0.032|0.05
91784510|NCT05126225|183449457|OTHER|Single group|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.067||0.05|TWO_SIDED|95.0|0.16|0.44|||t-test, 2 sided|||||0.440|0.160|0.05
91784511|NCT01904773|183449488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|0.9||0.0087||||||Bonferroni-Holm adjustment, compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||Comparison with placebo||||0.0087
91597855|NCT03861559|183086836|OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
91597856|NCT03861559|183086837|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597857|NCT03861559|183086839|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597858|NCT03861559|183086840|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91784512|NCT01904773|183449488|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.34|STANDARD_ERROR_OF_MEAN|0.85||0.1198||||||Bonferroni-Holm compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||||||0.1198
91784513|NCT00220779|183449493|SUPERIORITY_OR_OTHER|||||||0.221||||||0.2g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.221
91784514|NCT00220779|183449493|SUPERIORITY_OR_OTHER|||||||0.471||||||0.4 g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.471
91597859|NCT03861559|183086841|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597860|NCT03861559|183086843|OTHER|||||||0.14|||||||ANOVA|||||||0.14
91784515|NCT02891070|183449518|NON_INFERIORITY|To demonstrate non-inferiority (NI) of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.|Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
91784516|NCT02891070|183449520|OTHER||Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
91784517|NCT02891070|183449521|OTHER|||||||0.0241|||||||Wilcoxon (Mann-Whitney)|||||||0.0241
91597861|NCT03861559|183086844|OTHER|||||||0.02|||||||ANOVA|||||||0.02
91597862|NCT03861559|183086845|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597863|NCT03861559|183086847|OTHER|||||||0.15|||||||ANOVA|||||||0.15
91597864|NCT03861559|183086848|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597865|NCT03861559|183086849|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597866|NCT03861559|183086851|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597867|NCT03861559|183086852|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597868|NCT03861559|183086853|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597869|NCT03861559|183086854|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597870|NCT03861559|183086855|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597871|NCT03861559|183086856|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91597872|NCT02997904|183086857|SUPERIORITY||Least Squares Mean Difference|1.0058|STANDARD_ERROR_OF_MEAN|0.2131|<|0.0001|TWO_SIDED|95.0|0.5829|1.4288|||ANOVA|||Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \> Total Number of lice and eggs removed with sham control||1.4288|0.5829|<0.0001
91597873|NCT02997904|183086858|SUPERIORITY||Least Squares Mean Difference|1.2084|STANDARD_ERROR_OF_MEAN|0.0467|<|0.0001|TWO_SIDED|95.0|1.1157|1.3011||The P-Values were \<0.0001 in both comparison groups; total number lice removed and total number of eggs removed|GLIMMX|||Comparison of total number of lice removed and total number of eggs removed were analyzed separately||1.3011|1.1157|<0.0001
91597874|NCT02997904|183086858|SUPERIORITY||Least Squares Mean Difference|0.7899|STANDARD_ERROR_OF_MEAN|0.04565|<|0.0001|TWO_SIDED|95.0|0.6993|0.8805|||GLIMMX|||||0.8805|0.6993|<0.0001
91597875|NCT00631748|183086888|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|95.0|||||ANCOVA|We compared TLFB at baseline and at end of study.||We used a repeated-measures ANCOVA to compare cocaine usage between the two groups. This incorporated the multiple administrations of the Timeline Followback measure.||||<0.25
91784518|NCT02891070|183449522|OTHER|||||||0.1015|||||||Wilcoxon (Mann-Whitney)|||||||0.1015
91784519|NCT02891070|183449523|OTHER|||||||0.9943|||||||Wilcoxon (Mann-Whitney)|||||||0.9943
91784520|NCT02891070|183449524|OTHER||Mean Difference (Net)|-5.11|||||TWO_SIDED|95.0|-13.6|3.39|||Regression, Logistic|||||3.39|-13.60|
91784521|NCT04491604|183449563|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|45.8||||0.00192|TWO_SIDED|95.0|23.6|68.0|||McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (primary wounds with complete healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||68.0|23.6|0.00192
91784522|NCT04491604|183449564|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|51.0||||0.00047|TWO_SIDED|95.0|29.3|72.6||There is no multiplicity adjustment needed since the hypothesis testing are hierarchical.|McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (complete wound healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||72.6|29.3|0.00047
91784523|NCT00606905|183449586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.05|TWO_SIDED|95.0|0.41|4.61|||Chi-squared|||||4.61|0.41|<0.05
91597876|NCT00631748|183086889|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Cox|||End-of-trial abstinence was defined as a negative urine drug screen (for cocaine) for three consecutive weeks at the end of the study.||||.65
91597877|NCT03829657|183086894|SUPERIORITY||Odds Ratio (OR)|0.6||||0.196|TWO_SIDED|95.0|0.27|1.29|||Regression, Logistic|||||1.29|0.27|0.196
91597878|NCT01295216|183086905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-2.15|1.4|||||Systolic blood pressure at 12 months|||1.40|-2.15|
91597879|NCT01295216|183086905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-1.29|1.32|||||Diastolic blood pressure for 12 months|||1.32|-1.29|
91597880|NCT00562588|183086911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.067||||0.683||95.0|0.78|1.461|||Regression, Logistic|||The primary endpoint tele-mRS on day 90 was available in 527 of 543 treated patients (97.1%).||1.461|0.78|0.683
91597881|NCT00562588|183086912|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||ANCOVA|ANCOVA with factors for treatment, age, weight, baseline SBP, diabetes, previous stroke and baseline NIHSS||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||||0.607
91597882|NCT00562588|183086913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.202||95.0|0.442|1.189|||Cox proportional hazards model|||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||1.189|0.442|0.202
91649473|NCT05478603|183191545|OTHER||Ratio of adjusted geometric means|166.77|||||TWO_SIDED|90.0|92.21|301.62|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||301.62|92.21|
91784524|NCT04657666|183449587|SUPERIORITY||Combined least mean square difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7152|TWO_SIDED|95.0|-0.16|0.23||Based on a combination of 300 linear mixed models for crossover data on the response variable change from baseline in LLMT-6 with period level LLMT-6 baseline covariate, treatment group, period, and sequence as fixed effects.|Mixed Models Analysis|Pattern mixture model (PMM) control-based imputation, mixed model repeated measures (MMRM)||||0.23|-0.16|0.7152
91597883|NCT03257267|183086928|SUPERIORITY||Hazard Ratio (HR)|0.665|||<|1e-05|TWO_SIDED|95.0|0.555|0.796||One-sided p-value|Stratified Log-rank Test|||||0.796|0.555|<0.00001
91597884|NCT03257267|183086929|SUPERIORITY||Hazard Ratio (HR)|0.741||||0.00031|TWO_SIDED|95.0|0.623|0.882|||Stratified Log-rank Test|||||0.882|0.623|0.00031
91597885|NCT03257267|183086930|SUPERIORITY||Odds Ratio (OR)|3.136||||2e-05|TWO_SIDED|95.0|1.798|5.468|||Stratified Cochran-Mantel-Haenszel test|||||5.468|1.798|0.00002
91597886|NCT03257267|183086935|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.00024|TWO_SIDED|95.0|0.57|0.855||One-sided p-value|Stratified Log-rank Test|||||0.855|0.570|0.00024
91649474|NCT05478603|183191545|OTHER||Ratio of adjusted geometric means|237.76|||||TWO_SIDED|90.0|131.46|430.0|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||430.00|131.46|
91784525|NCT02386189|183449646|SUPERIORITY||Mean Difference (Net)|-4.65|STANDARD_DEVIATION|7.3||0.02|TWO_SIDED||||||t-test, 2 sided|||The t-test was conducted on change between baseline and 12-month follow-up.||||0.02
91784526|NCT02386189|183449647|SUPERIORITY||Mean Difference (Net)|2.91|STANDARD_DEVIATION|5.5||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
91784527|NCT02386189|183449648|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.7||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.71
91784528|NCT02386189|183449649|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
91597887|NCT01982292|183086941|SUPERIORITY_OR_OTHER||Difference in percentage|0.5|||>|0.9999|TWO_SIDED|90.0|-9.38|10.38|||Fisher Exact|||Difference in percentage of patients with positive antibody status||10.38|-9.38|>0.9999
91597888|NCT01982292|183086941|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5|||||TWO_SIDED|90.0|-10.38|9.38||||||Difference in percentage of patients with negative antibody status||9.38|-10.38|
91597889|NCT04872101|183086961|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.8|28.5||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||28.5|15.8|<0.001
91597890|NCT04872101|183086962|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|16.0|29.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.8|16.0|<0.001
91784529|NCT02386189|183449650|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|0.15||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
91597891|NCT04872101|183086963|SUPERIORITY||Risk Difference (RD)|6.5||||0.043|TWO_SIDED|95.0|0.8|12.3||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.3|0.8|0.043
91597892|NCT04872101|183086964|SUPERIORITY||Risk Difference (RD)|27.4|||<|0.001|TWO_SIDED|95.0|19.0|35.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.8|19.0|<0.001
91597893|NCT04872101|183086965|SUPERIORITY||Risk Difference (RD)|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.2||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.2|15.1|<0.001
91597894|NCT04872101|183086966|SUPERIORITY||Risk Difference (RD)|29.0|||<|0.001|TWO_SIDED|95.0|21.3|36.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||36.7|21.3|<0.001
91597895|NCT04872101|183086967|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|11.0|25.6||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||25.6|11.0|<0.001
91597896|NCT04872101|183086968|SUPERIORITY||Risk Difference (RD)|6.6||||0.031|TWO_SIDED|95.0|1.1|12.0||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.0|1.1|0.031
91597897|NCT04872101|183086969|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|17.5|32.5||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.5|17.5|<0.001
91784530|NCT02386189|183449651|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_DEVIATION|7.1||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
91784531|NCT02386189|183449652|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|8.9||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
91784532|NCT03120351|183449653|SUPERIORITY||Mean Difference (Net)|-2.5||||0.28|TWO_SIDED|95.0|-7.11|2.06|||Mixed Models Analysis|||||2.06|-7.11|0.28
91784533|NCT00332722|183449679|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
91784534|NCT00332722|183449680|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
91784535|NCT00486291|183449681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.||-0.2|-0.9|0.0007
91784536|NCT00486291|183449682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.1|-4.9|||ANCOVA|||||-4.9|-8.1|<0.0001
91784537|NCT04413617|183449705|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.0158|TWO_SIDED|90.0|-0.62|-0.08|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||-0.08|-0.62|0.0158
91597898|NCT04872101|183086970|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.001|TWO_SIDED|95.0|10.2|23.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||23.7|10.2|<0.001
91597899|NCT04872101|183086971|SUPERIORITY||Risk Difference (RD)|26.0|||<|0.001|TWO_SIDED|95.0|17.0|35.1||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.1|17.0|<0.001
91597900|NCT04872101|183086972|SUPERIORITY||Risk Difference (RD)|29.6|||<|0.001|TWO_SIDED|95.0|21.7|37.4||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||37.4|21.7|<0.001
91597901|NCT04872101|183086973|SUPERIORITY||Risk Difference (RD)|20.5|||<|0.001|TWO_SIDED|95.0|13.1|27.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.8|13.1|<0.001
91597902|NCT04872101|183086974|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.4|29.0||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.0|15.4|<0.001
91784538|NCT04413617|183449705|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.3933|TWO_SIDED|90.0|-0.32|0.23|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||0.23|-0.32|0.3933
91784539|NCT00984620|183449728|SUPERIORITY_OR_OTHER||Adjusted percent difference|-1.25||||0.855|TWO_SIDED|95.0|-14.3|11.8|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||11.8|-14.3|0.855
91784540|NCT00984620|183449729|SUPERIORITY_OR_OTHER||Adjusted percent difference|9.02||||0.229|TWO_SIDED|95.0|-5.3|23.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||23.3|-5.3|0.229
91784541|NCT00984620|183449730|SUPERIORITY_OR_OTHER||Adjusted percent difference|5.48||||0.417|TWO_SIDED|95.0|-7.3|18.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.3|-7.3|0.417
91784542|NCT00984620|183449731|SUPERIORITY_OR_OTHER||Adjusted percent difference|2.99||||0.676|TWO_SIDED|95.0|-10.6|16.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||16.6|-10.6|0.676
91784543|NCT00984620|183449732|SUPERIORITY_OR_OTHER||Adjusted percent difference|3.24||||0.588|TWO_SIDED|95.0|-8.1|14.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||14.6|-8.1|0.588
91784544|NCT00984620|183449733|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.78||||0.512|TWO_SIDED|95.0|-9.0|18.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.6|-9.0|0.512
91784545|NCT00984620|183449735|SUPERIORITY_OR_OTHER|||||||0.1397||||||Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test.|Log Rank|||||||0.1397
91784546|NCT00947882|183449757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0911||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0911
91790442|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91784547|NCT00947882|183449757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0865|TWO_SIDED|||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0865
91597903|NCT04872101|183086975|SUPERIORITY||Risk Difference (RD)|31.3|||<|0.001|TWO_SIDED|95.0|23.1|39.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.5|23.1|<0.001
91597904|NCT04872101|183086976|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.7|39.3||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.3|22.7|<0.001
91597905|NCT04872101|183086977|SUPERIORITY||Mean Difference (Net)|-45.5|||<|0.001|TWO_SIDED|95.0|-56.4|-34.6||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-34.6|-56.4|<0.001
91597906|NCT04872101|183086978|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.8||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.8|-5.0|<0.001
91597907|NCT04872101|183086979|SUPERIORITY||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.4|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.4|<0.001
91597908|NCT04872101|183086980|SUPERIORITY||Median Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.5|<0.001
91597909|NCT04872101|183086981|SUPERIORITY||Mean Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.5|-2.6|<0.001
91597910|NCT04872101|183086982|SUPERIORITY||Median Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-0.99|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-0.99|<0.001
91597911|NCT04872101|183086983|SUPERIORITY||Mean Difference (Net)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.01|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-1.01|<0.001
91709367|NCT01402986|183311377|SUPERIORITY_OR_OTHER||Rate Ratio|1.29||||0.506|TWO_SIDED|95.0|0.61|2.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.74|0.61|0.506
91784548|NCT00947882|183449757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.2342||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2342
91784549|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.0367||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0367
91784550|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0231||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0231
91784551|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.1638||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1638
91784552|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1941||||||P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1941
91784553|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.1083||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1083
91597912|NCT04872101|183086984|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|17.0|35.9||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.9|17.0|<0.001
91597913|NCT00879229|183086996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.0|STANDARD_ERROR_OF_MEAN|67.0||0.696|TWO_SIDED|95.0|-54.0|17.0||This is an exact Wilcoxon rank sum test p-value for testing equality of ambrisentan and placebo distributions.|Wilcoxon (Mann-Whitney)|||||17|-54|0.696
91784554|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.2782||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2782
91784555|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.1562||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1562
91790443|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.157||0.573|TWO_SIDED|95.0|-0.397|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.220|-0.397|0.573
91597914|NCT02475681|183087011|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.17|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The primary test to compare PFS between treatment arms was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR (Arm B/Arm A) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.17|0.06|<0.0001
91597915|NCT02475681|183087012|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.13|0.3|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.30|0.13|<0.0001
91597916|NCT02475681|183087013|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|8.3|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS||||22.3|8.3|<0.0001
91597917|NCT02475681|183087013|SUPERIORITY||Risk Difference (RD)|6.9||||0.0763|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.||||14.9|-1.0|0.0763
91597918|NCT02475681|183087014|SUPERIORITY||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.26|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.26|0.08|<0.0001
91597919|NCT02475681|183087014|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.15|0.4||P-value based on stratified by randomization stratification factors as recorded in IXRS|Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||0.40|0.15|<0.0001
91597920|NCT02475681|183087015|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0577|TWO_SIDED|95.0|0.21|1.06|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare overall survival between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||1.06|0.21|0.0577
91597921|NCT02475681|183087015|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.1556|TWO_SIDED|95.0|0.28|1.27|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||1.27|0.28|0.1556
91597922|NCT04999267|183087018|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91597923|NCT04999267|183087019|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<.0001
91597924|NCT01262365|183087021|SUPERIORITY||Odds Ratio (OR)|1.307|||=|0.175|TWO_SIDED|95.0|0.888|1.923|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.923|0.888|=0.175
91597925|NCT01262365|183087021|SUPERIORITY||Odds Ratio (OR)|1.164|||=|0.442|TWO_SIDED|95.0|0.79|1.714|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.714|0.790|=0.442
91597926|NCT00527605|183087027|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.23|||<|0.0001||95.0|-20.23|-8.22|||t-test, 2 sided||Dutasteride arm minus placebo arm.|||-8.22|-20.23|<0.0001
91597927|NCT02762513|183087072|OTHER||Median overall survival time (months)|9.8|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
91597928|NCT02762513|183087073|OTHER||Median PFS time (months)|3.5|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
91597929|NCT02111564|183087078|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.136|TWO_SIDED|95.0|0.52|1.09|||Cox proportional hazards model|||||1.09|0.52|0.136
91597930|NCT02111564|183087079|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.124|TWO_SIDED|95.0|0.84|4.23|||Cox proportional hazards model|||||4.23|0.84|0.124
91597931|NCT02111564|183087080|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.751|TWO_SIDED|95.0|0.62|1.42|||Cox proportional hazards model|||||1.42|0.62|0.751
91597932|NCT02111564|183087081|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.023|TWO_SIDED|95.0|0.22|0.89|||Cox proportional hazards model|||||0.89|0.22|0.023
91597933|NCT02111564|183087082|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.033|TWO_SIDED|95.0|0.54|0.97|||Cox proportional hazards model|||||0.97|0.54|0.033
91597934|NCT02111564|183087083|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.073|TWO_SIDED|95.0|0.6|1.02|||Cox proportional hazards model|||||1.02|0.60|0.073
91597935|NCT02111564|183087084|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.156|TWO_SIDED|95.0|0.58|1.09|||Cox proportional hazards model|||||1.09|0.58|0.156
91597936|NCT00179309|183087153|SUPERIORITY_OR_OTHER|||||||0.12|ONE_SIDED|95.0||||Multiple comparisons were not done.|Log Rank|||48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.||||0.12
91597937|NCT04986202|183087155|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.537|TWO_SIDED|95.0|-3.86|2.02||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||2.02|-3.86|0.537
91597938|NCT04986202|183087155|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.221|TWO_SIDED|95.0|-4.71|1.09||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||1.09|-4.71|0.221
91522436|NCT00985010|182919867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|5.0||0.05|||||||Chi-squared||The difference is between the percentage of deaths (males versus females) after six months in the patients with hepatic encephalophathy.|Clinical evolution was reported as percentage (still alive or death after six months of follow up).||||0.05
91597939|NCT04986202|183087156|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.559|TWO_SIDED|95.0|-5.7|10.5||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||10.5|-5.7|0.559
91597940|NCT04986202|183087156|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.195|TWO_SIDED|95.0|-2.7|13.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||13.3|-2.7|0.195
91597941|NCT04986202|183087157|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.289|TWO_SIDED|95.0|-4.71|1.41||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.41|-4.71|0.289
91597942|NCT04986202|183087157|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.571|TWO_SIDED|95.0|-3.86|2.13||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||2.13|-3.86|0.571
91597943|NCT04986202|183087157|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.89|TWO_SIDED|95.0|-3.8|3.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||3.30|-3.80|0.890
91597944|NCT04986202|183087157|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.558|TWO_SIDED|95.0|-4.55|2.46||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||2.46|-4.55|0.558
91597945|NCT04986202|183087158|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.619|TWO_SIDED|95.0|-11.1|6.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||6.6|-11.1|0.619
91597946|NCT04986202|183087158|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.522|TWO_SIDED|95.0|-5.8|11.4||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||11.4|-5.8|0.522
91597947|NCT04986202|183087158|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.267|TWO_SIDED|95.0|-4.4|15.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||15.8|-4.4|0.267
91597948|NCT04986202|183087158|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.657|TWO_SIDED|95.0|-7.6|12.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||12.1|-7.6|0.657
91597949|NCT04986202|183087159|SUPERIORITY||Geometric mean ratio|0.95||||0.312|TWO_SIDED|95.0|0.86|1.05||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.05|0.86|0.312
91597950|NCT04986202|183087159|SUPERIORITY||Geometric mean ratio|0.91||||0.07|TWO_SIDED|95.0|0.83|1.01||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.01|0.83|0.070
91597951|NCT04986202|183087159|SUPERIORITY||Geometric mean ratio|1.01||||0.911|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.911
91597952|NCT04986202|183087159|SUPERIORITY||Geometric mean ratio|1.01||||0.837|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.837
91597953|NCT04986202|183087159|SUPERIORITY||Geometric mean ratio|0.95||||0.37|TWO_SIDED|95.0|0.84|1.07||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.07|0.84|0.370
91597954|NCT04986202|183087159|SUPERIORITY||Geometric mean ratio|0.93||||0.205|TWO_SIDED|95.0|0.83|1.04||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.04|0.83|0.205
91597955|NCT04986202|183087160|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.183|TWO_SIDED|95.0|-0.2|1.2||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.2|-0.2|0.183
91784556|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.1736||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1736
91522437|NCT00985010|182919868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.05|STANDARD_DEVIATION|10.72||0.05||95.0|||||Wilcoxon (Mann-Whitney)||The difference is between manganese levels of women minus manganese levels of men.|Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).||||0.05
91522438|NCT00316173|182919871|SUPERIORITY_OR_OTHER||Percentage of participants with CR+PR|30.9||||||95.0|18.7|43.1||||||||43.1|18.7|
91522439|NCT03764072|182919896|SUPERIORITY|||||||0.2107||||||Dose response Model - Linear|Multiple Comparison Procedure-Modelling|||||||0.2107
91522440|NCT03764072|182919896|SUPERIORITY|||||||0.0766||||||Dose response Model - Emax|Multiple Comparison Procedure-Modelling|||||||0.0766
91522441|NCT03764072|182919896|SUPERIORITY|||||||0.0989||||||Dose response Model - Logistic|Multiple Comparison Procedure-Modelling|||||||0.0989
91522442|NCT03764072|182919896|SUPERIORITY|||||||0.0927||||||Dose-response Model - Sigmoid Emax|Multiple Comparison Procedure-Modelling|||||||0.0927
91522443|NCT03764072|182919898|SUPERIORITY|||||||0.3162|||||||Cochran-Mantel-Haenszel|||||||0.3162
91522444|NCT03764072|182919898|SUPERIORITY|||||||0.4613|||||||Cochran-Mantel-Haenszel|||||||0.4613
91522445|NCT03764072|182919898|SUPERIORITY|||||||0.4095|||||||Cochran-Mantel-Haenszel|||||||0.4095
91522446|NCT03764072|182919898|SUPERIORITY|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.1570
91522447|NCT03764072|182919898|SUPERIORITY|||||||0.9843|||||||Cochran-Mantel-Haenszel|||||||0.9843
91597956|NCT04986202|183087160|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-0.8|0.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||0.7|-0.8|0.898
91597957|NCT04986202|183087160|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.316|TWO_SIDED|95.0|-0.4|1.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.1|-0.4|0.316
91597958|NCT04986202|183087160|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.934|TWO_SIDED|95.0|-0.7|0.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||0.8|-0.7|0.934
91522448|NCT03764072|182919899|SUPERIORITY|||||||0.8714|||||||Cochran-Mantel-Haenszel|||||||0.8714
91522449|NCT03764072|182919899|SUPERIORITY|||||||0.5815|||||||Cochran-Mantel-Haenszel|||||||0.5815
91522450|NCT03764072|182919899|SUPERIORITY|||||||0.4308|||||||Cochran-Mantel-Haenszel|||||||0.4308
91522451|NCT03764072|182919899|SUPERIORITY|||||||0.4434|||||||Cochran-Mantel-Haenszel|||||||0.4434
91522452|NCT03764072|182919899|SUPERIORITY|||||||0.855|||||||Cochran-Mantel-Haenszel|||||||0.8550
91522453|NCT03764072|182919900|SUPERIORITY|||||||0.687|||||||Cochran-Mantel-Haenszel|||||||0.6870
91522454|NCT03764072|182919900|SUPERIORITY|||||||0.1515|||||||Cochran-Mantel-Haenszel|||||||0.1515
91522455|NCT03764072|182919900|SUPERIORITY|||||||0.603|||||||Cochran-Mantel-Haenszel|||||||0.6030
91522456|NCT03764072|182919900|SUPERIORITY|||||||0.1361|||||||Cochran-Mantel-Haenszel|||||||0.1361
91522457|NCT03764072|182919900|SUPERIORITY|||||||0.564|||||||Cochran-Mantel-Haenszel|||||||0.5640
91522458|NCT03764072|182919901|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.5405|TWO_SIDED|95.0|0.6|2.67|||Regression, Cox|||||2.67|0.60|0.5405
91522459|NCT03764072|182919901|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9011|TWO_SIDED|95.0|0.49|2.27|||Regression, Cox|||||2.27|0.49|0.9011
91522460|NCT03764072|182919901|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9127|TWO_SIDED|95.0|0.48|2.26|||Regression, Cox|||||2.26|0.48|0.9127
91522461|NCT03764072|182919901|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5619|TWO_SIDED|95.0|0.6|2.56|||Regression, Cox|||||2.56|0.60|0.5619
91522462|NCT03764072|182919901|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.709|TWO_SIDED|95.0|0.5|2.79|||Regression, Cox|||||2.79|0.50|0.7090
91522463|NCT03764072|182919902|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.5141|TWO_SIDED|95.0|0.61|2.72|||Regression, Cox|||||2.72|0.61|0.5141
91522464|NCT03764072|182919902|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9614|TWO_SIDED|95.0|0.45|2.12|||Regression, Cox|||||2.12|0.45|0.9614
91522465|NCT03764072|182919902|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9756|TWO_SIDED|95.0|0.46|2.14|||Regression, Cox|||||2.14|0.46|0.9756
91522466|NCT03764072|182919902|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5582|TWO_SIDED|95.0|0.6|2.57|||Regression, Cox|||||2.57|0.60|0.5582
91522467|NCT03764072|182919902|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7543|TWO_SIDED|95.0|0.49|2.71|||Regression, Cox|||||2.71|0.49|0.7543
91522468|NCT01024608|182919911|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.91|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05.|ANCOVA|Repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
91522469|NCT01024608|182919912|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.92|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
91522470|NCT01024608|182919913|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.48||||0.005|TWO_SIDED|95.0|-0.8|-0.1||A priori threshold for statistical significance is p\<0.05|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||||-0.1|-0.8|0.005
91522471|NCT01024608|182919914|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.56||||0.002|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction||||-0.2|-0.9|0.002
91522472|NCT00685945|182919950|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||The effect of bradykinin on net t-PA release was determined using general linear model-repeated measures ANOVA in which the between-subject variable was gender, and the within-subjects variables were drug (control, +L-NMMA, +L-NMMA plus isosorbide, or +L-NMMA plus sildenafil) and dose of bradykinin.||||0.04
91522473|NCT00685945|182919951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Repeated measures ANOVA||||||<0.001
91522474|NCT00847405|182919959|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.64||||||90.0|95.93|111.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111.97|95.93|
91522475|NCT00847405|182919960|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.81||||||90.0|97.95|107.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.91|97.95|
91522476|NCT00847405|182919961|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.25||||||90.0|98.35|108.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.41|98.35|
91522477|NCT04791761|182919985|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: No difference in average pain scores before medication between opioid and non-opioid groups.||||0.8
91522478|NCT04791761|182919985|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in average pain scores after medication between opioid and non-opioid groups.||||0.7
91522479|NCT04791761|182919986|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care post-operatively between opioid and non-opioid groups.||||0.2
91522480|NCT00676130|182920012|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.7|||<|0.05||95.0|-9.3|15.0|||Chi-squared|||The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.||15|-9.3|<0.05
91522481|NCT00676130|182920013|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||<|0.05|TWO_SIDED|95.0|-6.5|6.3|||Chi-squared|||We assessed the rate of progression to abscess in the two groups.||6.3|-6.5|<0.05
91522482|NCT01564368|182920014|SUPERIORITY||area under the curve (AUC)|0.53||||0.484|ONE_SIDED|95.0||0.61||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC1 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.61||0.484
91522483|NCT01564368|182920014|SUPERIORITY||area under the curve|0.6||||0.017|ONE_SIDED|95.0||0.68||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC2 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.68||0.017
91522484|NCT01564368|182920014|SUPERIORITY||area under the curve|0.61||||0.013|ONE_SIDED|95.0||0.69||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) is considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC3 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.69||0.013
91597959|NCT04986202|183087161|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.725|TWO_SIDED|95.0|-1.647|2.366||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||2.366|-1.647|0.725
91597960|NCT04986202|183087161|SUPERIORITY||Mean Difference (Final Values)|-0.594||||0.555|TWO_SIDED|95.0|-2.571|1.382||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.382|-2.571|0.555
91597961|NCT04986202|183087161|SUPERIORITY||Mean Difference (Final Values)|0.657||||0.586|TWO_SIDED|95.0|-1.71|3.025||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||3.025|-1.710|0.586
91597962|NCT04986202|183087161|SUPERIORITY||Mean Difference (Final Values)|-0.815||||0.486|TWO_SIDED|95.0|-3.108|1.478||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.478|-3.108|0.486
91597963|NCT04986202|183087162|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.968|TWO_SIDED|95.0|-4.1|3.9||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||3.9|-4.1|0.968
91597964|NCT04986202|183087162|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.251|TWO_SIDED|95.0|-6.3|1.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.6|-6.3|0.251
91597965|NCT04986202|183087162|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.872|TWO_SIDED|95.0|-4.8|5.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||5.7|-4.8|0.872
91597966|NCT04986202|183087162|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|No formal hypothesis testing and p-value is not adjusted for multiple comparisons.|Change from baseline at 24 weeks||4.1|-6.2|0.682
91597967|NCT04986202|183087164|SUPERIORITY||Geometric mean ratio|1.029||||0.76|TWO_SIDED|95.0|0.857|1.236||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.236|0.857|0.760
91597968|NCT04986202|183087164|SUPERIORITY||Geometric mean ratio|1.209||||0.039|TWO_SIDED|95.0|1.01|1.448||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Change from baseline at 16 weeks||1.448|1.010|0.039
91597969|NCT04986202|183087164|SUPERIORITY||Geometric mean ratio|1.111||||0.241|TWO_SIDED|95.0|0.931|1.326||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.326|0.931|0.241
91597970|NCT04986202|183087164|SUPERIORITY||Geometric mean ratio|1.19||||0.049|TWO_SIDED|95.0|1.001|1.414||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.414|1.001|0.049
91522485|NCT01564368|182920015|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV1 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
91597971|NCT04986202|183087164|SUPERIORITY||Geometric mean ratio|1.151||||0.158|TWO_SIDED|95.0|0.946|1.401||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.401|0.946|0.158
91597972|NCT04986202|183087164|SUPERIORITY||Geometric mean ratio|1.159||||0.131|TWO_SIDED|95.0|0.957|1.404||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.404|0.957|0.131
91597973|NCT04986202|183087165|SUPERIORITY||Geometric mean ratio|1.0111||||0.874|TWO_SIDED|95.0|0.8819|1.1592||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.1592|0.8819|0.874
91597974|NCT04986202|183087165|SUPERIORITY||Geometric mean ratio|0.9157||||0.2|TWO_SIDED|95.0|0.8002|1.0479||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.0479|0.8002|0.200
91597975|NCT04986202|183087165|SUPERIORITY||Geometric mean ratio|1.1063||||0.135|TWO_SIDED|95.0|0.969|1.2631||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2631|0.9690|0.135
91597976|NCT04986202|183087165|SUPERIORITY||Geometric mean ratio|1.0842||||0.22|TWO_SIDED|95.0|0.9527|1.2339||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2339|0.9527|0.220
91597977|NCT04986202|183087165|SUPERIORITY||Geometric mean ratio|1.0496||||0.467|TWO_SIDED|95.0|0.9211|1.196||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1960|0.9211|0.467
91597978|NCT04986202|183087165|SUPERIORITY||Geometric mean ratio|1.0312||||0.636|TWO_SIDED|95.0|0.908|1.1711||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1711|0.9080|0.636
91597979|NCT02469090|183087208|SUPERIORITY||LS mean differnce|-7.6|STANDARD_ERROR_OF_MEAN|1.96||0.0002|TWO_SIDED|95.0|-11.5|-3.7||The null-hypothesis to be tested was: H0: APL-130277 is the same as placebo in its effect on the motor function against the 2-sided alternative: H1: Either of the treatment groups is superior to the other in its effect on the motor function.|LS mean difference|To control the family-wise type I error rate, the primary and secondary end points were tested in hierarchical order in the order presented||Mixed effects model for repeated measures (MMRM) was used to estimate the treatment difference(APL-130277-placebo) Observed change from pre-dose MDS-UPDRS Part III score values after 30 minutes were response values. Treatment group, visit and the interaction between the treatment group and visit were fixed factors. Change from pre-dose in MDS-UPDRS Part III score after 30 minutes at the last TV at which the randomized dose was given up through TV6 was used as a covariate||-3.7|-11.5|0.0002
91597980|NCT02469090|183087209|SUPERIORITY||Adjusted odds ratio|2.81||||0.0426|TWO_SIDED|95.0|1.036|7.644|||Adjusted Odds Ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.644|1.036|0.0426
91597981|NCT02469090|183087210|SUPERIORITY||Adjusted odds ratio|2.8||||0.0501|TWO_SIDED|95.0|1.0|7.84||The hierarchical testing stopped at this endpoint due to non-significant result. P-values for endpoints after this endpoint have not been presented and the confidence interval presented are unadjusted for multiplicity.|Adjusted odds ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.84|1.00|0.0501
91649475|NCT05478603|183191546|OTHER||Ratio of adjusted geometric means|95.34|||||TWO_SIDED|90.0|52.67|172.59|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.59|52.67|
91709368|NCT01402986|183311377|SUPERIORITY_OR_OTHER||Rate Ratio|0.79||||0.243||95.0|0.53|1.18|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.18|0.53|0.243
91597982|NCT02469090|183087213|SUPERIORITY||LS mean difference|-1.1|||||TWO_SIDED|95.0|-3.159|0.959||||||||0.959|-3.159|
91597983|NCT02469090|183087214|SUPERIORITY||LS mean difference|47.6|||||TWO_SIDED|95.0|28.84|66.36||||||||66.36|28.84|
91597984|NCT02469090|183087215|SUPERIORITY||LS mean difference|1.979|||||TWO_SIDED|95.0|-2.162|6.12||||||||6.120|-2.162|
91597985|NCT02469090|183087216|SUPERIORITY||LS mean difference|-3.4|||||TWO_SIDED|95.0|-6.7|-0.2||||||||-0.2|-6.7|
91784557|NCT00947882|183449758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.3132||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.3132
91597986|NCT02469090|183087217|SUPERIORITY||Hazard ratio|3.4|||||TWO_SIDED|95.0|1.99|5.69||||||Median Time to effect for APL-130277 versus placebo patients||5.69|1.99|
91597987|NCT03823391|183087225|SUPERIORITY||Least Squares (LS) Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.215||0.022|TWO_SIDED|90.0|-0.89|-0.15|||Mixed-effect model repeated measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Between groups difference was a single-arm comparison of LS mean of ABBV-3373 estimated from the MMRM model above minus the historical mean of adalimumab (-2.13).|Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis consisting of 242 subjects from 3 historical adalimumab studies in which the success criterion was 2-sided P value ≤ 0.1.||-0.15|-0.89|0.022
91597988|NCT03823391|183087225|SUPERIORITY|||||||0.899||||||Posterior probability|Historical data borrowing|Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean \< 0 given the observed data was calculated.||The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab \> 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29.||||0.899
91597989|NCT03823391|183087225|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.353||0.683|TWO_SIDED|90.0|-0.74|0.45|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data.||0.45|-0.74|0.683
91597990|NCT03823391|183087226|SUPERIORITY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|3.207||0.601|TWO_SIDED|90.0|-7.08|3.7|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||3.70|-7.08|0.601
91597991|NCT03823391|183087227|SUPERIORITY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|3.205||0.737|TWO_SIDED|90.0|-6.47|4.3|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||4.30|-6.47|0.737
91597992|NCT03823391|183087228|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.418||0.612|TWO_SIDED|90.0|-0.92|0.49|||Mixed Effect Model Repeated Measurement|Analysis included treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||0.49|-0.92|0.612
91597993|NCT03823391|183087229|SUPERIORITY||Response Rate Difference|-4.0||||0.877|TWO_SIDED|90.0|-28.5|20.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||20.5|-28.5|0.877
91649476|NCT05478603|183191546|OTHER||Ratio of adjusted geometric means|163.09|||||TWO_SIDED|90.0|90.1|295.22|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||295.22|90.10|
91649477|NCT05478603|183191546|OTHER||Ratio of adjusted geometric means|239.47|||||TWO_SIDED|90.0|132.29|433.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||433.47|132.29|
91649478|NCT05003167|183191597|SUPERIORITY||F|8.48||||0.001|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.001
91649479|NCT05003167|183191599|SUPERIORITY||F|2.29||||0.113|TWO_SIDED|95.0|||||ANOVA|df = 2,44||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.113
91597994|NCT03823391|183087230|SUPERIORITY||Response Rate Difference|-13.1||||0.426|TWO_SIDED|90.0|-37.2|11.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||11.0|-37.2|0.426
91649480|NCT05003167|183191600|SUPERIORITY||F|3.17||||0.052|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.052
91597995|NCT05030311|183087232|SUPERIORITY||Mean Difference (Final Values)|-6.22|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-8.45|-4.0|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|||-4.00|-8.45|<0.001
91649481|NCT05003167|183191601|SUPERIORITY||F|0.07||||0.931|TWO_SIDED|95.0|||||ANOVA|||"A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.~Results here are for percent of breaths at major boundaries."||||.931
91790444|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790445|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.154||0.689|TWO_SIDED|95.0|-0.241|0.365||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.365|-0.241|0.689
91522486|NCT01564368|182920015|SUPERIORITY||area under the curve|0.63|||<|0.001|ONE_SIDED|95.0||0.71||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV2 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.71||<0.001
91522487|NCT01564368|182920015|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV3 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
91522488|NCT01564368|182920016|EQUIVALENCE|no equivalence margin was used.||||||0.032|||||||z-test|||AUC (optimized) = AUC (ΔADC)||||0.032
91522489|NCT04810221|182920042|OTHER|Paired T-test 0|Mean Difference (Final Values)|0.18||||0.31|TWO_SIDED|95.0|-0.17|0.54|||Paired T-test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.54|-0.17|0.31
91522490|NCT04810221|182920043|OTHER|Paired T test 0|Mean Difference (Final Values)|0.25||||0.32|TWO_SIDED|95.0|-0.24|0.75|||Paired T test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.75|-0.24|0.32
91522491|NCT01342458|182920046|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Mixed Models Analysis|||Sample size was calculated based on pain WOMAC score and was accomplished using a moderate effect size (f=0.30). Standard deviation estimates were taken from our previous study. A sample size of 56 patients was needed to provide 80% power for detecting a moderate effect difference between the highest and lowest group pain means, with an alpha level of 0.05, a statistical design of F test of repeated measures (between and within effects), and assuming a 10% loss to follow-up.||||0.006
91522492|NCT01342458|182920046|SUPERIORITY_OR_OTHER||Effect Size|1.46|||<|0.001|TWO_SIDED||||||post hoc newman keuls|||From baseline to 3rd month.||||<0.001
91522493|NCT01342458|182920046|SUPERIORITY_OR_OTHER||Effect size|1.94|||<|0.001|TWO_SIDED||||||post hoc Newman Keuls|||From baseline to 6th month.||||<0.001
91522494|NCT01342458|182920046|SUPERIORITY_OR_OTHER||Effect size|0.82||||0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||0.001
91522495|NCT01342458|182920046|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522496|NCT01342458|182920047|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.015
91522497|NCT01342458|182920047|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91649482|NCT05003167|183191601|SUPERIORITY||F|0.23||||0.164|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. Results reflect percent of breaths at boundaries unrelated to syntax.||||0.164
91649483|NCT01010230|183191609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.69|TWO_SIDED|95.0|-5.59|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-5.59|0.69
91790446|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790447|NCT02880956|183460064|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.159||0.662|TWO_SIDED|95.0|-0.243|0.382||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.382|-0.243|0.662
91522498|NCT01342458|182920047|SUPERIORITY_OR_OTHER||Effect size|0.7|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522499|NCT01342458|182920047|SUPERIORITY_OR_OTHER||Effect size|0.25|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91522500|NCT01342458|182920047|SUPERIORITY_OR_OTHER||Effect size|0.16|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522501|NCT01342458|182920048|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
91649484|NCT01010230|183191610|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.18||||0.18|TWO_SIDED|95.0|0.0|0.35||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.35|0.00|0.18
91649485|NCT01010230|183191611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.85|TWO_SIDED|95.0|-6.93|9.25||The threshold for significance was established a priori at alpha=0.05|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||9.25|-6.93|0.85
91784558|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.2034|TWO_SIDED|95.0|0.814|2.628||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 3."|||2.628|0.814|0.2034
91597996|NCT05030311|183087233|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.544|<|0.001|TWO_SIDED|95.0|-3.7|-1.56|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-1.56|-3.70|<0.001
91597997|NCT05030311|183087234|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.635|<|0.001|TWO_SIDED|95.0|-4.85|-2.36|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.36|-4.85|<0.001
91597998|NCT05030311|183087235|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.001|TWO_SIDED|95.0|2.0|4.84|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Disease activity control (UAS7 =\< 6) at Week 12||4.84|2.00|<0.001
91597999|NCT05030311|183087236|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.16|6.82|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Complete absence of hives and itch (UAS7 = 0) at Week 12||6.82|2.16|<0.001
91598000|NCT05030311|183087237|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|6.18|39.77|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|||39.77|6.18|<0.001
91598001|NCT05030311|183087238|SUPERIORITY||Rate ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.01|3.61|||Negative binomial regression model|Negative binomial regression model with log link, using treatment arm, geographical region, and prior exposure to anti-IgE biologics as covariates.||||3.61|2.01|<0.001
91598002|NCT05030311|183087239|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.53|3.9|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|||3.90|1.53|<0.001
91598003|NCT05030311|183087240|SUPERIORITY||Rate ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.41|||Regression, Linear||Statistical model used a negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.41|1.12|<0.001
91598004|NCT01425203|183087242|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|29.2|||<|0.0001|TWO_SIDED|95.0|16.4|41.5||Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization.||41.5|16.4|<0.0001
91598005|NCT01425203|183087243|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|30.2|||<|0.0001|TWO_SIDED|95.0|17.3|42.5||Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors.||42.5|17.3|<0.0001
91598006|NCT01425203|183087244|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|45.6|||<|0.0001|TWO_SIDED|95.0|33.2|57.0|||Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population.||57.0|33.2|<0.0001
91598007|NCT02264990|183087257|SUPERIORITY|A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.|Hazard Ratio (HR)|0.644||||0.113|TWO_SIDED|95.0|0.396|1.048||Statistical significance was determined by a two-sided P value ≤ 0.05.|Log Rank|Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.|Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.048|0.396|0.113
91598008|NCT02264990|183087258|OTHER||Hazard Ratio (HR)|0.647||||0.26|TWO_SIDED|95.0|0.388|1.08|||Log Rank|Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.080|0.388|0.260
91598009|NCT02264990|183087259|OTHER||Odds Ratio (OR)|0.66||||0.455|TWO_SIDED|95.0|0.23|1.9|||Regression, Logistic|Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.90|0.23|0.455
91598010|NCT02264990|183087260|OTHER||Hazard Ratio (HR)|0.986||||0.846|TWO_SIDED|95.0|0.827|1.176|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.176|0.827|0.846
91598011|NCT02264990|183087261|OTHER||Hazard Ratio (HR)|1.035||||0.473|TWO_SIDED|95.0|0.867|1.235|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.235|0.867|0.473
91598012|NCT02264990|183087262|OTHER||Odds Ratio (OR)|0.86||||0.409|TWO_SIDED|95.0|0.59|1.24|||Regression, Logistic|Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.24|0.59|0.409
91598013|NCT02275338|183087267|OTHER|||||||0.0055||||||The expected proportion of responders using Lanreotide was 50%, 1 sided test, 2.5% significance level alpha and power of 80% using Z-test for binomial proportion.|Binomial test|||One sided binomial test to compare percentage of responding subjects to theoretical proportion of 30%.||||0.0055
91598014|NCT01100944|183087285|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91598015|NCT01100944|183087294|SUPERIORITY_OR_OTHER|||||||0.3||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.30
91598016|NCT01100944|183087294|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
91598017|NCT01100944|183087294|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
91598018|NCT01100944|183087295|SUPERIORITY_OR_OTHER|||||||0.76||||||Fold change at Cycle 2 Day 1 vs. pre was assessed.Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.76
91598019|NCT01100944|183087295|SUPERIORITY_OR_OTHER|||||||0.0009||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0009
91598020|NCT01100944|183087295|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
91598021|NCT01100944|183087296|SUPERIORITY_OR_OTHER|||||||0.95||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.95
91784559|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1748|TWO_SIDED|95.0|0.834|2.71||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 3."|||2.710|0.834|0.1748
91522502|NCT01342458|182920048|SUPERIORITY_OR_OTHER||Effect size|1.28|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91598022|NCT01100944|183087296|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
91598023|NCT01100944|183087296|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
91598024|NCT03603496|183087306|SUPERIORITY||Risk Ratio (RR)|1.18||||0.19|TWO_SIDED|95.0|0.92|1.5|||Chi-squared||Comparing TTCM as numerator, QL as denominator (reference group)|Two-stage multiple imputation techniques were used to estimate the missing smoking outcomes. 1st stage: we imputed missing data from surveys. 2nd stage: we imputed missing data from biochemical sample collection. Null hypothesis was no difference between arms in biochemically-validated past 7-day abstinence from cigarettes and other conventional tobacco products at 6-months. Sample of 1350 (675/group) was planned to detect a 6.5% difference (23.0% vs. 16.5%) with 84% power and 2-sided p\<0.05.||1.50|0.92|.19
91598025|NCT03603496|183087307|SUPERIORITY||Risk Ratio (RR)|1.22||||0.002|TWO_SIDED|95.0|1.08|1.35|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.35|1.08|.002
91598026|NCT03603496|183087308|SUPERIORITY||Risk Ratio (RR)|1.23||||0.001|TWO_SIDED|95.0|1.09|1.37|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.37|1.09|.001
91598027|NCT03603496|183087309|SUPERIORITY||Risk Ratio (RR)|1.13||||0.079|TWO_SIDED|95.0|0.98|1.29|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.29|0.98|.079
91598028|NCT03603496|183087310|SUPERIORITY||Risk Ratio (RR)|1.32|||<|0.0001|TWO_SIDED|95.0|1.21|1.44|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.44|1.21|<.0001
91598029|NCT03603496|183087311|SUPERIORITY||Risk Ratio (RR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.23|1.5|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.50|1.23|<.0001
91598030|NCT03603496|183087312|SUPERIORITY||Risk Ratio (RR)|1.31||||0.033|TWO_SIDED|95.0|1.02|1.66|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.66|1.02|.033
91598031|NCT01179009|183087337|SUPERIORITY|||||||0.53||||||The p-value above represents the interaction between the treatment group and time.|ANOVA|||||||0.53
91598032|NCT01179009|183087338|SUPERIORITY|||||||0.06||||||The p-value above comes from a model where the treatment group is used to predict the CGI improvement score.|Ordinal regression|||||||0.06
91598033|NCT00623428|183087339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4557|TWO_SIDED|95.0|0.45|1.43|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|"The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.~(second column)."|In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.||1.43|0.45|0.4557
91598034|NCT00623428|183087340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0788|TWO_SIDED|95.0|0.33|1.06|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.06|0.33|0.0788
91598035|NCT00623428|183087341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.5654|TWO_SIDED|95.0|0.48|3.87|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||3.87|0.48|0.5654
91598036|NCT00623428|183087343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
91598037|NCT00623428|183087344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
91784560|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0658|TWO_SIDED|95.0|0.964|3.195||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 3."|||3.195|0.964|0.0658
91598038|NCT01692301|183087346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.66|STANDARD_ERROR_OF_MEAN|1.42||0.01|TWO_SIDED|95.0|-6.45|-0.87|||ANCOVA|||||-0.87|-6.45|0.010
91598039|NCT02249143|183087363|SUPERIORITY||Mean Difference (Net)|6.62|||<|0.05|TWO_SIDED|95.0|0.02|13.22|||Regression, Linear|||FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.||13.22|0.02|<0.05
91598040|NCT02249143|183087364|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91784561|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0587|TWO_SIDED|95.0|0.979|3.184||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 4."|||3.184|0.979|0.0587
91522503|NCT01342458|182920048|SUPERIORITY_OR_OTHER||Effect size|1.58|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91598041|NCT02249143|183087364|SUPERIORITY|||||||||||||||||Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.||||
91598042|NCT01967537|183087405|SUPERIORITY|||||||0.23|||||||Mann-Whitney|||||||0.23
91598043|NCT02425826|183087409|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-39.84|||<|0.0001|TWO_SIDED|95.0|-54.39|-25.3|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-25.30|-54.39|<0.0001
91598044|NCT02425826|183087410|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5||||0.0008|TWO_SIDED|95.0|-3.9|-1.0|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-1.0|-3.9|0.0008
91598045|NCT02425826|183087411|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.0|||<|0.0001|TWO_SIDED|95.0|11.0|31.1||Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.|Cochran-Mantel-Haenszel||Two-sided 95% confidence intervals (CI) is based on normal approximation|||31.1|11.0|<0.0001
91598046|NCT02425826|183087412|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.7||||0.0365|TWO_SIDED|95.0|1.7|25.7|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||25.7|1.7|0.0365
91598047|NCT02425826|183087413|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.6||||0.0016|TWO_SIDED|95.0|-18.8|-4.5|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||The treatment comparison was only done for Week 16; End of Phase||-4.5|-18.8|0.0016
91522504|NCT01342458|182920048|SUPERIORITY_OR_OTHER||Effect size|0.68|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91522505|NCT01342458|182920048|SUPERIORITY_OR_OTHER||Effect size|0.42|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522506|NCT01342458|182920049|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
91649486|NCT01010230|183191612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19||||0.12|TWO_SIDED|95.0|0.43|5.95||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||5.95|0.43|0.12
91522507|NCT01342458|182920049|SUPERIORITY_OR_OTHER||Effect size|1.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91522508|NCT01342458|182920049|SUPERIORITY_OR_OTHER||Effect size|1.69||||0.019|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||0.019
91522509|NCT01342458|182920049|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91522510|NCT01342458|182920049|SUPERIORITY_OR_OTHER||Effect size|0.44|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522511|NCT01342458|182920050|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.019
91522512|NCT01342458|182920050|SUPERIORITY_OR_OTHER||Effect size|1.07|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91522513|NCT01342458|182920050|SUPERIORITY_OR_OTHER||Effect size|1.31|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522514|NCT01342458|182920050|SUPERIORITY_OR_OTHER||Effect size|0.71|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
91522515|NCT01342458|182920050|SUPERIORITY_OR_OTHER||Effect size|0.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
91522516|NCT01342458|182920051|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.425
91522517|NCT01342458|182920052|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.443
91522518|NCT01342458|182920053|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference in paracetamol intake at 6-month.||||<0.001
91522519|NCT01181726|182920054|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.66|||||TWO_SIDED|90.0|94.22|116.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.25|94.22|
91598048|NCT02425826|183087414|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.8||||0.0463|TWO_SIDED|95.0|-4.0|27.6|||Cochran-Mantel-Haenszel|p-value was based on 2-sided CMH tests stratified by sites.|Two-sided 95% CI is based on normal approximation.|||27.6|-4.0|0.0463
91598049|NCT02425826|183087415|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.8|||<|0.0001|TWO_SIDED|95.0|10.36|25.24|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM-Effectiveness||25.24|10.36|<0.0001
91598050|NCT02425826|183087415|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0||||0.3433|TWO_SIDED|95.0|-5.4|15.4|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM - Side Effects||15.40|-5.40|0.3433
91598051|NCT02425826|183087415|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.4||||0.625|TWO_SIDED|95.0|-4.25|7.06|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSMQ-Convenience||7.06|-4.25|0.6250
91598052|NCT02425826|183087415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.07|||<|0.0001|TWO_SIDED|95.0|7.16|20.97|||ANOVA|||TSQM-Global Satisfaction||20.97|7.16|<0.0001
91649487|NCT01010230|183191613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.97|TWO_SIDED|95.0|-4.24|4.05||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage (from general linear model).||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.05|-4.24|0.97
91649488|NCT01010230|183191614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.91|TWO_SIDED|95.0|-4.05|4.68||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.68|-4.05|0.91
91649489|NCT01010230|183191615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.4|TWO_SIDED|95.0|-0.69|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-0.69|0.40
91598053|NCT02425826|183087417|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-54.08|-19.91|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate||||-19.91|-54.08|<0.0001
91598054|NCT02425826|183087418|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.3|41.8|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||41.8|16.3|<0.0001
91598055|NCT02425826|183087419|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.5||||0.0136|TWO_SIDED|95.0|4.4|22.7|||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test stratified by sites.|2-sided 95% CI is based on normal approximation.|||22.7|4.4|0.0136
91649490|NCT01010230|183191616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.73|TWO_SIDED|95.0|-2.02|3.33||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.33|-2.02|0.73
91598056|NCT02164981|183087467|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.57|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE\_score = BASELINE\_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).||||0.57
91649491|NCT01010230|183191617|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.2||||0.08|TWO_SIDED|95.0|0.06|0.34||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.34|0.06|0.08
91598057|NCT02164981|183087467|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.54|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.||||0.54
91598058|NCT02164981|183087468|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.35|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparison.|ANCOVA|||||||0.35
91598059|NCT02164981|183087468|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.37|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparisons|ANCOVA|||||||0.37
91598060|NCT02164981|183087469|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.85|TWO_SIDED||||||ANCOVA|||||||0.85
91598061|NCT02164981|183087469|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.88|TWO_SIDED||||||ANCOVA|||||||0.88
91598062|NCT02164981|183087470|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.86|TWO_SIDED||||||ANCOVA|||||||0.86
91598063|NCT02164981|183087470|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.83|TWO_SIDED||||||ANCOVA|||||||0.83
91598064|NCT02164981|183087476|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
91598065|NCT02164981|183087476|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
91598066|NCT02164981|183087479|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
91598067|NCT02164981|183087479|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
91649492|NCT01010230|183191618|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.13||||0.17|TWO_SIDED|95.0|0.0|0.26||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.26|0.00|0.17
91784562|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.049|TWO_SIDED|95.0|1.003|3.283||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 4."|||3.283|1.003|0.0490
91784563|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.2742|TWO_SIDED|95.0|0.774|2.464||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 4."|||2.464|0.774|0.2742
91598068|NCT01662440|183087503|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.|Difference in percentages of subjects|0.0|||||TWO_SIDED|97.5|-2.8|2.8||||||To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.||2.8|-2.8|
91598069|NCT01662440|183087504|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|97.5|-4.8|7.9||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination||7.9|-4.8|
91598070|NCT01662440|183087505|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.|Between groups ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.86|1.32||||||Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination||1.32|0.86|
91598071|NCT01662440|183087506|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.||1.13|0.68|
91598072|NCT01662440|183087507|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-3.8|1.4||||||Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination||1.4|-3.8|
91598073|NCT01662440|183087508|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-4.1|6.2||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.||6.2|-4.1|
91598074|NCT01765673|183087522|OTHER|||||||0.218|||||||paired t test|||||||0.218
91598075|NCT01765673|183087523|OTHER|||||||0.017|||||||paired t test|||||||0.017
91598076|NCT01765673|183087524|OTHER|||||||0.022|||||||paired t test|||||||0.022
91598077|NCT01765673|183087525|OTHER|||||||0.719|||||||paired t test|||||||0.719
91598078|NCT01765673|183087526|OTHER|||||||0.418|||||||paired t test|||||||0.418
91790448|NCT02880956|183460064|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91598079|NCT01765673|183087527|OTHER|||||||0.038|||||||paired t test|||||||0.038
91598080|NCT01765673|183087528|OTHER|||||||0.086|||||||paired t test|||||||0.086
91598081|NCT01765673|183087529|OTHER|||||||0.16|||||||paired t test|||||||0.16
91598082|NCT01765673|183087530|OTHER|||||||0.052|||||||paired t test|||||||0.052
91598083|NCT01765673|183087531|OTHER|||||||0.827|||||||paired t test|||||||0.827
91598084|NCT01765673|183087532|OTHER|||||||0.088|||||||paired t test|||||||0.088
91598085|NCT01765673|183087533|OTHER|||||||0.152|||||||paired t test|||||||0.152
91598086|NCT01765673|183087534|OTHER|||||||0.229|||||||paired t test|||||||0.229
91598087|NCT01765673|183087535|OTHER|||||||0.121|||||||paired t test|||||||0.121
91598088|NCT01765673|183087536|OTHER|||||||0.239|||||||paired t test|||||||0.239
91598089|NCT01765673|183087537|OTHER|||||||0.03|||||||paired t test|||||||0.03
91598090|NCT01765673|183087538|OTHER|||||||0.067|||||||paired t test|||||||0.067
91598091|NCT01765673|183087539|OTHER|||||||0.396|||||||paired t test|||||||0.396
91598092|NCT01765673|183087540|OTHER|||||||0.373|||||||paired t test|||||||0.373
91598093|NCT01765673|183087541|OTHER|||||||0.744|||||||paired t test|||||||0.744
91598094|NCT02025426|183087578|OTHER|||||||0.547|||||||Kruskal-Wallis|||||||0.547
91598095|NCT02025426|183087580|OTHER|||||||0.925|||||||Kruskal-Wallis|||||||0.925
91598096|NCT02025426|183087581|OTHER|||||||0.498|||||||Kruskal-Wallis|||||||0.498
91598097|NCT02025426|183087582|OTHER|||||||0.201|||||||Kruskal-Wallis|||||||0.201
91598098|NCT02025426|183087583|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91598099|NCT02025426|183087584|OTHER|||||||0.962|||||||Fisher Exact|||||||0.962
91598100|NCT02025426|183087585|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91598101|NCT01008280|183087621|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.||||<0.01
91649493|NCT01010230|183191619|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.08||||0.38|TWO_SIDED|95.0|-0.04|0.2||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.20|-0.04|0.38
91598102|NCT01008280|183087621|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.||||>0.01
91598103|NCT01008280|183087621|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.||||>0.01
91598104|NCT01008280|183087622|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.||||<0.01
91598105|NCT01008280|183087622|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.||||>0.01
91598106|NCT01008280|183087622|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.||||>0.01
91598107|NCT01008280|183087623|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.||||<0.01
91598108|NCT01008280|183087623|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.||||>0.01
91598109|NCT01008280|183087623|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.||||>0.01
91598110|NCT00122135|183087634|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||.77
91598111|NCT01394081|183087638|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<.0001
91598112|NCT01394081|183087639|SUPERIORITY||||||<|0.0001|||||||Log Rank|log rank Mantel Cox χ2 = 25.4||||||<.0001
91598113|NCT03806127|183087701|OTHER||Cochran-Mantel-Haenszel (CMH) Difference|-1.9|||||TWO_SIDED|90.0|-16.1|12.3|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||12.3|-16.1|
91598114|NCT03806127|183087702|OTHER||CMH Difference|9.1|||||TWO_SIDED|90.0|-4.8|22.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-D Participants||22.9|-4.8|
91598115|NCT03806127|183087702|OTHER||CMH Difference|-0.1|||||TWO_SIDED|90.0|-16.7|16.4|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-M Participants||16.4|-16.7|
91784564|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4206|TWO_SIDED|95.0|0.706|2.304||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 5."|||2.304|0.706|0.4206
91784565|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5494|TWO_SIDED|95.0|0.664|2.16||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 5."|||2.160|0.664|0.5494
91784566|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7586|TWO_SIDED|95.0|0.609|1.975||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 5."|||1.975|0.609|0.7586
91784567|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1946|TWO_SIDED|95.0|0.816|2.717||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 6."|||2.717|0.816|0.1946
91784568|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.538|TWO_SIDED|95.0|0.667|2.174||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 6."|||2.174|0.667|0.5380
91784569|NCT00947882|183449759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.4263|TWO_SIDED|95.0|0.702|2.308||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 6."|||2.308|0.702|0.4263
91598116|NCT03806127|183087702|OTHER||CMH Difference|5.3|||||TWO_SIDED|90.0|-5.4|15.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|All Participants||15.9|-5.4|
91649494|NCT01010230|183191620|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|-0.02||||0.88|TWO_SIDED|95.0|-0.22|0.18||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.18|-0.22|0.88
91649495|NCT01010230|183191621|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.28||||0.06|TWO_SIDED|95.0|0.09|0.46||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.46|0.09|0.06
91649496|NCT00530439|183191628|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
91649497|NCT02367781|183191631|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.639|||<|0.0001|TWO_SIDED|95.0|0.536|0.763|||Log Rank|||||0.763|0.536|<.0001
91649498|NCT02367781|183191632|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.788||||0.0298|TWO_SIDED|95.0|0.636|0.977|||Log Rank|||||0.977|0.636|0.0298
91790449|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.184||0.291|TWO_SIDED|95.0|-0.555|0.167||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.167|-0.555|0.291
91598117|NCT03806127|183087703|OTHER||CMH Difference|1.6|||||TWO_SIDED|90.0|-11.7|14.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|||14.9|-11.7|
91598118|NCT03806127|183087704|OTHER||CMH Difference|6.7|||||TWO_SIDED|90.0|-5.5|18.8|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||18.8|-5.5|
91598119|NCT02163434|183087711|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91598120|NCT02163434|183087712|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
91598121|NCT02163434|183087713|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91649499|NCT02367781|183191633|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.545|0.768|||Log Rank|||ITT Population||0.768|0.545|<0.0001
91649500|NCT02367781|183191633|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.561|||<|0.0001|TWO_SIDED|95.0|0.432|0.728|||Log Rank|||TC1/2/3 or IC1/2/3-WT ITT Population||0.728|0.432|<0.0001
91709369|NCT01402986|183311377|SUPERIORITY_OR_OTHER||Rate Ratio|0.87||||0.531|TWO_SIDED|95.0|0.57|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.34|0.57|0.531
91649501|NCT02367781|183191633|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.549|||<|0.0001|TWO_SIDED|95.0|0.425|0.708|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.708|0.425|<0.0001
91649502|NCT02367781|183191634|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.837||||0.0732|TWO_SIDED|95.0|0.689|1.017|||Log Rank|||||1.017|0.689|0.0732
91649503|NCT02367781|183191635|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.752||||0.083|TWO_SIDED|95.0|0.545|1.039|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||1.039|0.545|0.0830
91649504|NCT02367781|183191635|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.746||||0.0813|TWO_SIDED|95.0|0.536|1.038|||Log Rank|||TC1/2/3 or IC1/2/3 WT ITT Population||1.038|0.536|0.0813
91649505|NCT02367781|183191636|SUPERIORITY|Stratified Analysis|Difference in Response Rate|19.21|||<|0.0001|TWO_SIDED|95.0|11.05|27.37|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|||27.37|11.05|<.0001
91649506|NCT02367781|183191637|SUPERIORITY|Unstratified Analysis|Difference in Response Rate|16.89|||<|0.0001|TWO_SIDED|95.0|8.9|24.88|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|ITT Population||24.88|8.90|<.0001
91598122|NCT02163434|183087715|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91598123|NCT02163434|183087716|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
91598124|NCT01289015|183087733|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
91598125|NCT05726318|183087739|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
91598126|NCT05726318|183087741|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
91598127|NCT05726318|183087742|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||.68
91598128|NCT05726318|183087744|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
91598129|NCT05726318|183087745|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
91598130|NCT04302727|183087746|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
91598131|NCT04302727|183087746|SUPERIORITY||Median Difference (Net)|0.37||||0.64|TWO_SIDED|95.0|-1.19|1.93|||Mixed Models Analysis|||Fully adjusted model||1.93|-1.19|0.64
91598132|NCT04302727|183087747|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Month 4||||<0.0001
91598133|NCT04302727|183087747|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Month 12||||0.67
91649507|NCT02367781|183191637|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|1.38|3.56||||||TC1/2/3 or IC1/2/3 ITT WT Population||3.56|1.38|
91649508|NCT02367781|183191637|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.21||||0.0007|TWO_SIDED|95.0|1.39|3.51|||Cochran-Mantel-Haenszel|||TC1/2/3 or IC1/2/3 ITT Population||3.51|1.39|0.0007
91649509|NCT02367781|183191638|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.614||||0.0002|TWO_SIDED|95.0|0.473|0.797|||Log Rank|||ITT Population||0.797|0.473|0.0002
91709370|NCT03749109|183311410|OTHER||Difference in LS mean|1.74||||0.78|TWO_SIDED|95.0|-10.45|13.94|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.94|-10.45|0.78
91709371|NCT03749109|183311410|OTHER||Difference in LS mean|3.35||||0.29|TWO_SIDED|95.0|-2.89|9.59|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||9.59|-2.89|0.29
91649510|NCT02367781|183191638|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.458|0.785|||Log Rank|||ITT-WT Population||0.785|0.458|0.0002
91598134|NCT04302727|183087748|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Participants with diabetes-Month 4||||0.02
91598135|NCT04302727|183087748|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Participants without diabetes-Month 4||||<0.0001
91598136|NCT04302727|183087748|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Participants with diabetes-Month 12||||0.82
91598137|NCT04302727|183087748|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Participants without diabetes-Month 12||||0.75
91598138|NCT04302727|183087748|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Participants with diabetes-Month 24||||0.87
91598139|NCT04302727|183087748|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Participants without diabetes-Month 24||||0.27
91598140|NCT04302727|183087748|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Females-Month 4||||<0.0001
91598141|NCT04302727|183087748|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Females-Month 12||||0.66
91598142|NCT04302727|183087748|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Females-Month 24||||0.96
91598143|NCT04302727|183087748|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Males-Month 4||||0.0003
91598144|NCT04302727|183087748|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||Males-Month 12||||0.34
91790450|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91598145|NCT04302727|183087748|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Males-Month 24||||0.20
91649511|NCT02367781|183191638|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.548||||0.0011|TWO_SIDED|95.0|0.379|0.791|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.791|0.379|0.0011
91649512|NCT02367781|183191638|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.551||||0.0014|TWO_SIDED|95.0|0.381|0.798|||Log Rank|||TC1/2/3 or IC1/2/3 ITT WT Population||0.798|0.381|0.0014
91649513|NCT02367781|183191639|SUPERIORITY||Difference in Event Free Rate|7.46||||0.0647|TWO_SIDED|95.0|-0.45|15.37|||Z-test|||Event Free Rate (%) at Year 1 ITT WT Population||15.37|-0.45|0.0647
91598146|NCT04302727|183087748|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Whites-Month 4||||<0.0001
91598147|NCT04302727|183087748|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Whites-Month 12||||0.83
91598148|NCT04302727|183087748|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||Whites-Month 24||||0.54
91598149|NCT04302727|183087748|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||African Americans-Month 4||||0.008
91598150|NCT04302727|183087748|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||African Americans-Month 12||||0.58
91598151|NCT04302727|183087748|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||African Americans-Month 24||||0.79
91598152|NCT04302727|183087749|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Month 4||||<0.001
91598153|NCT04302727|183087749|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||Month 12||||0.57
91598154|NCT04302727|183087749|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Month 24||||0.32
91598155|NCT04302727|183087750|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Month 4||||0.77
91598156|NCT04302727|183087750|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Month 12||||0.48
91598157|NCT04302727|183087750|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Month 24||||0.68
91598158|NCT04302727|183087751|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Month 4||||0.91
91598159|NCT04302727|183087751|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||Month 12||||0.52
91598160|NCT04302727|183087751|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Month 24||||0.97
91598161|NCT04302727|183087752|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Month 4||||0.29
91598162|NCT04302727|183087752|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
91598163|NCT04302727|183087752|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Month 12||||0.09
91598164|NCT04302727|183087753|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Month 4||||0.96
91598165|NCT04302727|183087753|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Month 12||||0.77
91598166|NCT04302727|183087753|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Month 24||||0.94
91598167|NCT04302727|183087754|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Month 4||||0.55
91598168|NCT04302727|183087754|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Month 12||||0.83
91598169|NCT04302727|183087754|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Month 24||||0.44
91598170|NCT04302727|183087755|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Month 4||||0.99
91598171|NCT04302727|183087755|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Month 12||||0.71
91598172|NCT04302727|183087755|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Month 24||||0.44
91598173|NCT04302727|183087756|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Month 4||||0.05
91598174|NCT04302727|183087756|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Month 12||||0.42
91598175|NCT04302727|183087756|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Month 24||||0.02
91598176|NCT04302727|183087757|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Month 4||||0.10
91598177|NCT04302727|183087757|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Month 12||||0.56
91598178|NCT04302727|183087757|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
91598179|NCT04302727|183087758|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Month 4, comparison performed on log base 2 transformation of fluorescence data.||||0.96
91598180|NCT04302727|183087758|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Month 12, comparison performed on log base 2 transformation of fluorescence data.||||0.88
91598181|NCT04302727|183087758|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Month 24, comparison performed on log base 2 transformation of fluorescence data.||||0.29
91598182|NCT04302727|183087759|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Month 4, comparison performed on log base 2 transformation of fluorescence data.||||0.82
91598183|NCT04302727|183087759|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Month 12, comparison performed on log base 2 transformation of fluorescence data.||||0.25
91598184|NCT04302727|183087759|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Month 24, comparison performed on log base 2 transformation of fluorescence data.||||0.48
91649514|NCT02367781|183191639|SUPERIORITY||Difference in Event Free Rate|8.07||||0.0516|TWO_SIDED|95.0|-0.06|16.19|||Z-test|||Event Free Rate (%) at Year 2 ITT WT Population||16.19|-0.06|0.0516
91784570|NCT00947882|183449760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76||||0.4607|TWO_SIDED|95.0|-10.113|4.59||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||4.590|-10.113|0.4607
91784571|NCT00947882|183449760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24||||0.3876|TWO_SIDED|95.0|-10.614|4.128||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||4.128|-10.614|0.3876
91784572|NCT00947882|183449760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28||||0.2548|TWO_SIDED|95.0|-11.65|3.096||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||3.096|-11.650|0.2548
91598185|NCT04302727|183087760|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||Month 4||||0.0007
91598186|NCT04302727|183087760|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Month 12||||0.51
91598187|NCT04302727|183087760|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Month 24||||0.91
91598188|NCT04302727|183087761|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Month 4||||0.83
91598189|NCT04302727|183087761|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Month 12||||0.68
91598190|NCT04302727|183087761|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Month 24||||0.64
91598191|NCT04302727|183087762|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Month 4||||<0.0001
91598192|NCT04302727|183087762|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Month 12||||<0.0001
91598193|NCT04302727|183087762|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||Month 24||||0.005
91598194|NCT04302727|183087763|SUPERIORITY|||||||0.92||||||Month 4|Wilcoxon (Mann-Whitney)|||||||0.92
91598195|NCT04302727|183087763|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12||||0.40
91598196|NCT04302727|183087763|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 24||||0.82
91598197|NCT04302727|183087764|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Month 4||||0.44
91598198|NCT04302727|183087764|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Month 12||||0.03
91598199|NCT04302727|183087764|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Month 24||||0.28
91598200|NCT04302727|183087765|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Month 4||||0.32
91598201|NCT04302727|183087765|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Month 12||||0.03
91598202|NCT04302727|183087765|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||Month 24||||0.005
91598203|NCT04302727|183087766|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Month 4||||0.10
91598204|NCT04302727|183087766|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Month 12||||0.16
91598205|NCT04302727|183087766|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Month 24||||0.27
91598206|NCT04302727|183087767|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Month 4||||0.10
91598207|NCT04302727|183087767|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Month 12||||0.01
91598208|NCT04302727|183087767|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Month 24||||0.06
91598209|NCT04302727|183087768|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||Month 4||||0.41
91598210|NCT04302727|183087768|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Month 12||||0.24
91598211|NCT04302727|183087768|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||Month 24||||0.74
91598212|NCT04302727|183087769|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Month 4||||0.13
91598213|NCT04302727|183087769|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Month 12||||0.10
91598214|NCT04302727|183087769|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Month 24||||0.12
91598215|NCT04302727|183087770|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Month 4||||0.002
91598216|NCT04302727|183087770|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Month 12||||<0.001
91598217|NCT04302727|183087770|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Month 24||||<0.001
91598218|NCT01294800|183087786|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7||||0.0564|TWO_SIDED|95.0|-1.37|0.02|||Constrained longitudinal data analysis|||||0.02|-1.37|0.0564
91598219|NCT01294800|183087786|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.1844|TWO_SIDED|95.0|-1.16|0.22|||Constrained longitudinal data analysis|||||0.22|-1.16|0.1844
91598220|NCT01294800|183087786|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.3||||0.3386|TWO_SIDED|95.0|-1.04|0.36|||Constrained longitudinal data analysis|||||0.36|-1.04|0.3386
91598221|NCT01294800|183087787|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.404|TWO_SIDED|95.0|-7.75|19.0|||A generalized linear mixed model|||||19.00|-7.75|0.404
91598222|NCT01294800|183087787|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.39|TWO_SIDED|95.0|-7.73|18.81|||A generalized linear mixed model|||||18.81|-7.73|0.390
91598223|NCT01294800|183087787|SUPERIORITY_OR_OTHER||Difference in proportions of responders|-4.9||||0.508|TWO_SIDED|95.0|-17.78|7.97|||A generalized linear mixed model|||||7.97|-17.78|0.508
91598224|NCT01294800|183087788|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.7||||0.0509|TWO_SIDED|95.0|0.0|1.43|||Constrained longitudinal data analysis|||||1.43|-0.00|0.0509
91598225|NCT01294800|183087788|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.1847|TWO_SIDED|95.0|-0.23|1.19|||Constrained longitudinal data analysis|||||1.19|-0.23|0.1847
91598226|NCT01294800|183087788|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.2021|TWO_SIDED|95.0|-0.25|1.19|||Constrained longitudinal data analysis|||||1.19|-0.25|0.2021
91649515|NCT02367781|183191639|SUPERIORITY||Difference in Event Free Rate|7.19||||0.0683|TWO_SIDED|95.0|-0.54|14.91|||Z-test|||Event Free Rate (%) at Year 1 ITT Population||14.91|-0.54|0.0683
91649516|NCT02367781|183191639|SUPERIORITY||Difference in Event Free Rate|7.53||||0.0625|TWO_SIDED|95.0|-0.39|15.44|||Z-test|||Event Free Rate (%) at Year 2 ITT Population||15.44|-0.39|0.0625
91784573|NCT00947882|183449760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.5652|TWO_SIDED|95.0|-9.729|5.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||5.322|-9.729|0.5652
91598227|NCT00493038|183087824|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|2.1||||||95.0|-1.9|6.2|||||Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.2|-1.9|
91598228|NCT00493038|183087825|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|-0.5||||||95.0|-7.9|6.8||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.8|-7.9|
91598229|NCT00493038|183087826|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|1.7||||||95.0|-3.8|7.1||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.1|-3.8|
91598230|NCT01888640|183087849|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.008|TWO_SIDED|95.0|-1.8|-0.2||To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni's method|Linear mixed models for repeated measure|||Visit 2-Visit 3||-0.2|-1.8|0.008
91598231|NCT01888640|183087849|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.6|<0.0001
91598232|NCT01888640|183087850|SUPERIORITY||Mean Difference (Net)|-1.3||||0.002|TWO_SIDED|95.0|-2.2|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.2|0.002
91598233|NCT01888640|183087850|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.8|<0.0001
91598234|NCT01888640|183087851|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-2.1|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.1|0.0006
91598235|NCT01888640|183087851|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.2|<0.0001
91598236|NCT01888640|183087852|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.001|TWO_SIDED|95.0|-2.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.4|0.001
91649517|NCT02367781|183191640|SUPERIORITY||Difference in Event Free Rate|6.69||||0.2385|TWO_SIDED|95.0|-4.44|17.83|||Z-test|||Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT||17.83|-4.44|0.2385
91649518|NCT02367781|183191640|SUPERIORITY||Difference in Event Free Rate|8.64||||0.271|TWO_SIDED|95.0|-6.75|24.03|||Z-test|||Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT||24.03|-6.75|0.2710
91598237|NCT01888640|183087852|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.9|-0.9|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.9|-2.9|<0.0001
91649519|NCT02367781|183191640|SUPERIORITY||Difference in Event Free Rate|6.34||||0.2733|TWO_SIDED|95.0|-5.0|17.67|||Z-test|||Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT||17.67|-5.00|0.2733
91649520|NCT02367781|183191640|SUPERIORITY||Difference in Event Free Rate|8.69||||0.2909|TWO_SIDED|95.0|-7.44|24.81|||Z-test|||Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT||24.81|-7.44|0.2909
91649521|NCT02367781|183191641|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.3342|TWO_SIDED|95.0|0.711|1.123|||Log Rank|||||1.123|0.711|0.3342
91649522|NCT02060461|183191655|OTHER|||||||0.003|||||||t-test, 2 sided|||Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetry||||.003
91649523|NCT00740727|183191658|SUPERIORITY_OR_OTHER||% of subjects with infusion pain|11.1||||||95.0|1.4|34.7|||95% binomial exact confidence interval|||This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.||34.7|1.4|
91709372|NCT03749109|183311410|OTHER||Difference in LS mean|0.33||||0.95|TWO_SIDED|95.0|-10.33|10.99|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||10.99|-10.33|0.95
91709373|NCT03749109|183311411|OTHER||Difference in LS mean|-6.99||||0.65|TWO_SIDED|95.0|-36.8|22.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||22.82|-36.80|0.65
91598238|NCT01888640|183087853|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.011|TWO_SIDED|95.0|-2.2|-0.2|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.2|-2.2|0.011
91598239|NCT01888640|183087853|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-3.0|<0.0001
91598240|NCT01888640|183087854|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-2.2|0.016
91598241|NCT01888640|183087854|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0002|TWO_SIDED|95.0|-2.6|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.6|0.0002
91598242|NCT01888640|183087855|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.074|TWO_SIDED|95.0|-10.4|0.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.3|-10.4|0.074
91598243|NCT01888640|183087855|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.005|TWO_SIDED|95.0|-12.4|-1.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.8|-12.4|0.005
91598244|NCT01888640|183087856|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.018|TWO_SIDED|95.0|-1.7|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-1.7|0.018
91649524|NCT00740727|183191659|SUPERIORITY_OR_OTHER||% subjects with next-day EASI site pain|0.0||||||97.5|0.0|18.5|||binomial exact confidence interval|Because the point estimate was zero, the statistical software (STATA version 10MP) reports a one-sided 97.5% confidence interval.||This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.||18.5|0|
91649525|NCT05321810|183191665|OTHER|||||||0.016|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.016
91649526|NCT05321810|183191670|OTHER||Hazard Ratio (HR)|0.812||||0.013|TWO_SIDED|95.0|0.69|0.957|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.957|0.690|0.013
91649527|NCT05321810|183191676|OTHER|||||||0.002|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.002
91784574|NCT00947882|183449760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.7502|TWO_SIDED|95.0|-8.768|6.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||6.322|-8.768|0.7502
91790451|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|-0.36|STANDARD_ERROR_OF_MEAN|0.182||0.051|TWO_SIDED|95.0|-0.713|0.001||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.001|-0.713|0.051
91598245|NCT01888640|183087856|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-1.9|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.9|0.0006
91598246|NCT01888640|183087857|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.043|TWO_SIDED|95.0|-1.3|-0.01|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.01|-1.3|0.043
91598247|NCT01888640|183087857|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.048|TWO_SIDED|95.0|-1.3|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.3|0.048
91598248|NCT01888640|183087858|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.036|TWO_SIDED|95.0|-1.0|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.0|0.036
91598249|NCT01888640|183087858|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.4|<0.0001
91598250|NCT01888640|183087859|SUPERIORITY||Mean Difference (Final Values)|-0.4|||>|0.99|TWO_SIDED|95.0|-2.3|1.5|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.5|-2.3|>0.99
91598251|NCT01888640|183087859|SUPERIORITY||Mean Difference (Final Values)|-0.6|||>|0.99|TWO_SIDED|95.0|-2.4|1.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.3|-2.4|>0.99
91598252|NCT01888640|183087860|SUPERIORITY||Mean Difference (Final Values)|1.1|||>|0.99|TWO_SIDED|95.0|-1.9|4.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||4.1|-1.9|>0.99
91598253|NCT01888640|183087860|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.17|TWO_SIDED|95.0|-0.6|5.3|||Linear mixed models for repeated measure|||||5.3|-0.6|0.17
91598254|NCT01888640|183087861|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.36|TWO_SIDED|95.0|-0.7|3.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||3.1|-0.7|0.36
91598255|NCT01888640|183087861|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-0.8|2.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||2.8|-0.8|0.58
91598256|NCT01888640|183087862|SUPERIORITY||Mean Difference (Final Values)|19.0|||>|0.99|TWO_SIDED|95.0|-58.0|96.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||96|-58|>0.99
91598257|NCT01888640|183087862|SUPERIORITY||Mean Difference (Final Values)|42.0|||>|0.99|TWO_SIDED|95.0|-34.0|117.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||117|-34|>0.99
91598258|NCT01888640|183087863|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.96|TWO_SIDED|95.0|-0.2|0.7|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.7|-0.2|0.96
91598259|NCT01888640|183087863|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.008|TWO_SIDED|95.0|0.1|1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.0|0.1|0.008
91598260|NCT01888640|183087864|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
91598261|NCT01888640|183087864|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
91598262|NCT00684788|183087871|SUPERIORITY||Odds Ratio (OR)|5.68|||=|0.008|TWO_SIDED|95.0|1.61|20.02|||General Estimating Equation (GEE)|||||20.02|1.61|=0.008
91598263|NCT00684788|183087872|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||||||0.0033
91598264|NCT00684788|183087875|SUPERIORITY||Odds Ratio (OR)|1.05||||0.939|TWO_SIDED|95.0|0.32|3.42|||General Estimating Equation (GEE)|||||3.42|0.32|0.939
91598265|NCT00684788|183087877|SUPERIORITY||Odds Ratio (OR)|1.074||||0.959|TWO_SIDED|95.0|0.071|16.245|||General Estimating Equation (GEE)|||||16.245|0.071|0.959
91649528|NCT05321810|183191679|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
91598266|NCT01142726|183087878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.55||0.01|TWO_SIDED|95.0|1.18|3.43|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Month 12|Power estimate assumed 2-sided alpha level of 5% and that 60% of abatacept (ABA)+methotrexate (MX) patients (pts) would be in DAS28-CRP remission at Month 12 compared with 38% of MX monotherapy pts. Also assumed that 48% of ABA monotherapy pts would be in DAS28-CRP remission at Month 12, yielding an expected treatment difference from MX of 10% in favor of ABA monotherapy; 116 pts randomized to ABA monotherapy would yield a half-length of the 95% CI around that 10% treatment difference of 13.5%.||3.43|1.18|0.010
91598267|NCT01142726|183087878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|STANDARD_ERROR_OF_MEAN|1.15||0.045|TWO_SIDED|95.0|1.02|6.18|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Months 12 and 18|Conditional on statistical significance of the 1st coprimary efficacy analysis (CEA), a sample of 116 patients per arm would provide 98% power for the 2nd CEA comparison of the percentage of patients in DAS28-CRP remission at Months 12 and 18 between the abatacept (ABA)+methotrexate (MTX) arm and the MTX monotherapy arm for intent-to treat population. This sample size calculation assumed 30% remission in the ABA+MTX arm and 8% in the monotherapy arm at Month 18 and a 2-sided alpha level of 5%.||6.18|1.02|0.045
91598268|NCT01142726|183087879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.55|1.57|||||At Month 12|||1.57|0.55|
91598269|NCT01142726|183087879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|0.81|5.14|||||At Months 12 and 18|||5.14|0.81|
91598270|NCT02109484|183087902|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0165|||||||Wilcoxon (Mann-Whitney)|||||||0.0165
91598271|NCT02109484|183087902|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||<0.0001
91598272|NCT02109484|183087902|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91598273|NCT02109484|183087903|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were peformed||||<0.0001
91598274|NCT02109484|183087903|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91598275|NCT02109484|183087903|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||||||0.0006
91598276|NCT02109484|183087904|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Group B 10 mcg P2-VP8 was performed.||||0.0004
91598277|NCT02109484|183087904|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Cohort B 30 mcg P2-VP8 vaccine group was performed.||||<0.0001
91598278|NCT02109484|183087904|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair-wise comparison between the Adjusted Seroresponses in Cohort B Placebo group and the Cohort B P2-VP8 group was performed.||||<0.0001
91598279|NCT01890642|183087911|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.01
91598280|NCT01890642|183087912|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Kruskal-Wallis|||||||0.80
91598281|NCT01890642|183087913|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Kruskal-Wallis|||||||0.004
91598282|NCT01890642|183087914|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Kruskal-Wallis|||||||0.0001
91598283|NCT01890642|183087915|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Kruskal-Wallis|||||||0.37
91598284|NCT01223703|183087944|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||"null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.~for unpaired data."||||< 0.05
91598285|NCT01223703|183087945|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||||||< 0.05
91598286|NCT00784654|183087948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||< 0.001
91598287|NCT00784654|183087949|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91598288|NCT00784654|183087950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.4|-9.8|||ANCOVA|||||-9.8|-15.4|<0.001
91598289|NCT00784654|183087953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91598290|NCT00784654|183087957|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
91598291|NCT00784654|183087958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|||<|0.001|TWO_SIDED|95.0|3.5|9.5|||ANCOVA|||||9.5|3.5|<0.001
91598292|NCT00784654|183087959|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
91598293|NCT00784654|183087960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA|||||-0.11|-0.26|<0.001
91598294|NCT00784654|183087963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Cochran-Mantel-Haenszel|||||||0.726
91598295|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.39|0.84|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.84|0.39|
91598296|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.01|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.01|0.54|
91598297|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.5|1.11|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.11|0.50|
91598298|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.38|0.9|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.38|
91598299|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.37|0.74|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.37|
91598300|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.52|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.52|
91598301|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.46|0.95|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.95|0.46|
91598302|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.45|1.25|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.25|0.45|
91649529|NCT05321810|183191680|OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.42|0.773|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.773|0.420|<0.001
91649530|NCT05321810|183191682|OTHER|||||||0.35|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.350
91649531|NCT05321810|183191683|OTHER||Hazard Ratio (HR)|1.155||||0.324|TWO_SIDED|95.0|0.867|1.54|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.540|0.867|0.324
91522520|NCT01181726|182920055|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|93.91|101.02|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.02|93.91|
91522521|NCT01181726|182920056|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|94.05|101.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.30|94.05|
91522522|NCT01181726|182920057|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.35|||||TWO_SIDED|90.0|92.21|107.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.06|92.21|
91522523|NCT01181726|182920058|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.21|||||TWO_SIDED|90.0|91.21|99.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.39|91.21|
91522524|NCT01181726|182920059|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.25|||||TWO_SIDED|90.0|91.18|99.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.51|91.18|
91522525|NCT01181726|182920060|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.33|||||TWO_SIDED|90.0|92.21|107.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.00|92.21|
91598303|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.54|
91598304|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.35|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.35|
91598305|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.34|0.67|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.67|0.34|
91649532|NCT05321810|183191685|OTHER|||||||0.111|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.111
91649533|NCT05321810|183191686|OTHER||Hazard Ratio (HR)|0.866||||0.1|TWO_SIDED|95.0|0.73|1.028|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.028|0.730|0.100
91649534|NCT05321810|183191688|OTHER|||||||0.979|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.979
91784575|NCT00947882|183449760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.6089|TWO_SIDED|95.0|-9.513|5.581||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||5.581|-9.513|0.6089
91784576|NCT00947882|183449761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.8511|TWO_SIDED|95.0|-1.068|1.294||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||1.294|-1.068|0.8511
91784577|NCT00947882|183449761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.6331|TWO_SIDED|95.0|-0.9|1.477||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||1.477|-0.900|0.6331
91784578|NCT00947882|183449761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.909|TWO_SIDED|95.0|-1.113|1.25||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||1.250|-1.113|0.9090
91784579|NCT00947882|183449761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.5469|TWO_SIDED|95.0|-0.956|1.802||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||1.802|-0.956|0.5469
91784580|NCT00947882|183449761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.7906|TWO_SIDED|95.0|-1.576|1.2||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||1.200|-1.576|0.7906
91784581|NCT00947882|183449761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.5757|TWO_SIDED|95.0|-1.773|0.987||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||0.987|-1.773|0.5757
91784582|NCT02447302|183449764|SUPERIORITY||Difference in least square mean|-0.99|STANDARD_ERROR_OF_MEAN|0.42|=|0.0091|TWO_SIDED|90.0|-1.68|-0.3||The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.30|-1.68|= 0.0091
91784583|NCT02447302|183449764|SUPERIORITY||Difference in least square mean|-0.43|STANDARD_ERROR_OF_MEAN|0.41|=|0.1457|TWO_SIDED|90.0|-1.11|0.24||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.24|-1.11|= 0.1457
91784584|NCT02447302|183449765|SUPERIORITY||MH estimate for difference in percentage|24.4|STANDARD_ERROR_OF_MEAN|8.87|=|0.003|TWO_SIDED|90.0|9.8|39.0||Mantel-Haenszel (MH) estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||39.0|9.8|= 0.003
91784585|NCT02447302|183449765|SUPERIORITY||MH estimate for difference in percentage|4.1|STANDARD_ERROR_OF_MEAN|7.98|=|0.3059|TWO_SIDED|90.0|-9.1|17.2||MH estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.2|-9.1|= 0.3059
91784586|NCT02447302|183449766|SUPERIORITY||Difference in least square mean|-0.84|STANDARD_ERROR_OF_MEAN|0.29|=|0.002|TWO_SIDED|90.0|-1.32|-0.36||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.36|-1.32|= 0.0020
91784587|NCT02447302|183449766|SUPERIORITY||Difference in least square mean|-0.39|STANDARD_ERROR_OF_MEAN|0.28|=|0.0858|TWO_SIDED|90.0|-0.85|0.08||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.08|-0.85|= 0.0858
91790452|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|1.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91598306|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.37|0.88|||||Confidence intervals for the ratio are back transformation of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.88|0.37|
91598307|NCT00562354|183087970|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.3|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.30|
91784588|NCT02447302|183449767|SUPERIORITY||Difference in least square mean|-1.27|STANDARD_ERROR_OF_MEAN|0.55|=|0.01|TWO_SIDED|90.0|-2.17|-0.37||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.37|-2.17|= 0.0100
91784589|NCT02447302|183449767|SUPERIORITY||Difference in least square mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|=|0.1277|TWO_SIDED|90.0|-1.48|0.27||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.27|-1.48|= 0.1277
91784590|NCT02447302|183449768|SUPERIORITY||Odds Ratio (OR)|2.78|||=|0.0071|TWO_SIDED|90.0|1.4|5.51||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||The primary comparison in the study was between etrasimod 2 mg versus placebo.||5.51|1.40|= 0.0071
91598308|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-4.9|||||TWO_SIDED|95.0|-12.1|2.0||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.0|-12.1|
91598309|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.6|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-11.6|
91598310|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.6|2.2||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.2|-9.6|
91598311|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-13.7|2.5||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-13.7|
91598312|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.7|2.1||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.7|
91598313|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-1.6|||||TWO_SIDED|95.0|-5.9|2.1||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.9|
91598314|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.8|-0.9||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.9|-10.8|
91598315|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-8.7|6.9||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-8.7|
91598316|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.1|-4.0|
91598317|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.6|2.5||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-7.6|
91598318|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-2.8|4.7||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.7|-2.8|
91598319|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.7||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.7|-8.8|
91649535|NCT05321810|183191689|OTHER||Hazard Ratio (HR)|1.002||||0.978|TWO_SIDED|95.0|0.854|1.177|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.177|0.854|0.978
91598320|NCT00562354|183087973|SUPERIORITY_OR_OTHER||difference in proportions|-6.2|||||TWO_SIDED|95.0|-14.1|1.5||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-14.1|
91598321|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-7.2|||||TWO_SIDED|95.0|-15.1|0.3||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.3|-15.1|
91598322|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-5.4|||||TWO_SIDED|95.0|-14.5|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-14.5|
91598323|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-11.2|||||TWO_SIDED|95.0|-21.4|-1.0||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.0|-21.4|
91598324|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-4.7|||||TWO_SIDED|95.0|-13.5|3.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.9|-13.5|
91598325|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-5.1|||||TWO_SIDED|95.0|-14.3|4.0||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.0|-14.3|
91598326|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-12.9|||||TWO_SIDED|95.0|-24.6|-0.8||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.8|-24.6|
91598327|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-7.3|||||TWO_SIDED|95.0|-16.3|1.5||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-16.3|
91649536|NCT05321810|183191691|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
91649537|NCT05321810|183191692|OTHER||Hazard Ratio (HR)|0.428|||<|0.001|TWO_SIDED|95.0|0.263|0.697|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.697|0.263|<0.001
91649538|NCT05321810|183191696|OTHER||Hazard Ratio (HR)|0.727||||0.001|TWO_SIDED|95.0|0.599|0.881|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.881|0.599|0.001
91598328|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-17.5|||||TWO_SIDED|95.0|-29.5|-5.0||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.0|-29.5|
91598329|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||||TWO_SIDED|95.0|-21.4|2.4||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.4|-21.4|
91598330|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-10.5|||||TWO_SIDED|95.0|-19.3|-1.3||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.3|-19.3|
91598331|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-6.2|7.9||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.9|-6.2|
91598332|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-3.8|||||TWO_SIDED|95.0|-12.2|4.5||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.5|-12.2|
91598333|NCT00562354|183087976|SUPERIORITY_OR_OTHER||difference in proportions|-2.5|||||TWO_SIDED|95.0|-12.5|7.3||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.3|-12.5|
91598334|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-5.7|||||TWO_SIDED|95.0|-13.8|2.1||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-13.8|
91598335|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-15.9|5.0||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||5.0|-15.9|
91598336|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-18.3|||||TWO_SIDED|95.0|-30.1|-5.9||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.9|-30.1|
91709374|NCT03749109|183311411|OTHER||Difference in LS mean|-1.13||||0.92|TWO_SIDED|95.0|-22.77|20.51|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||20.51|-22.77|0.92
91709375|NCT03749109|183311411|OTHER||Difference in LS mean|-5.92||||0.74|TWO_SIDED|95.0|-40.94|29.1|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||29.10|-40.94|0.74
91784591|NCT02447302|183449768|SUPERIORITY||Odds Ratio (OR)|1.61|||=|0.1192|TWO_SIDED|90.0|0.83|3.14||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||||3.14|0.83|= 0.1192
91784592|NCT02447302|183449769|SUPERIORITY||MH estimate for difference in percentage|25.8|STANDARD_ERROR_OF_MEAN|7.47|=|0.0003|TWO_SIDED|90.0|13.5|38.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||38.1|13.5|= 0.0003
91598337|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-11.6|6.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-11.6|
91709376|NCT03749109|183311412|OTHER||Odds Ratio (OR)|1.04||||0.95|TWO_SIDED|95.0|0.38|2.82|||Regression, Logistic|||Endometrioma||2.82|0.38|0.95
91598338|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.6|-1.2||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-22.6|
91709377|NCT03749109|183311412|OTHER||Odds Ratio (OR)|0.55||||0.39|TWO_SIDED|95.0|0.14|2.17|||Regression, Logistic|||Adenomyosis||2.17|0.14|0.39
91709378|NCT03749109|183311413|OTHER||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|95.0|0.19|2.65|||Regression, Logistic|||Endometrioma||2.65|0.19|0.60
91598339|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-11.0|||||TWO_SIDED|95.0|-23.8|1.9||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.9|-23.8|
91598340|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-9.5|||||TWO_SIDED|95.0|-19.3|0.4||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.4|-19.3|
91598341|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-26.9|||||TWO_SIDED|95.0|-39.0|-14.1||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-14.1|-39.0|
91598342|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-6.4|||||TWO_SIDED|95.0|-18.7|6.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.1|-18.7|
91598343|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-12.2|||||TWO_SIDED|95.0|-22.6|-1.7||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.7|-22.6|
91598344|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||8.1|-9.8|
91598345|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||||TWO_SIDED|95.0|-21.7|-1.2||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-21.7|
91598346|NCT00562354|183087979|SUPERIORITY_OR_OTHER||difference in proportions|-7.7|||||TWO_SIDED|95.0|-18.5|3.4||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.4|-18.5|
91598347|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.6|||||TWO_SIDED|95.0|0.43|0.86|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.86|0.43|
91598348|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.8|||||TWO_SIDED|95.0|0.63|1.0|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.00|0.63|
91598349|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.66|||||TWO_SIDED|95.0|0.48|0.91|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.91|0.48|
91598350|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.5|0.85|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.85|0.50|
91598351|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.71|||||TWO_SIDED|95.0|0.52|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.52|
91598352|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.48|0.9|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.48|
91709379|NCT03749109|183311413|OTHER||Odds Ratio (OR)|0.35||||0.21|TWO_SIDED|95.0|0.07|1.79|||Regression, Logistic|||Adenomyosis||1.79|0.07|0.21
91709380|NCT03749109|183311414|OTHER||Rate Ratio|2.53||||0.13|TWO_SIDED|95.0|0.76|8.39|||Negative-binomial regression|||Endometrioma - Disappearing Lesions||8.39|0.76|0.13
91598353|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.74|||||TWO_SIDED|95.0|0.56|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.56|
91598354|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.46|||||TWO_SIDED|95.0|0.35|0.61|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.61|0.35|
91598355|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.76|||||TWO_SIDED|95.0|0.56|1.03|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.03|0.56|
91598356|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.57|||||TWO_SIDED|95.0|0.43|0.74|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.43|
91598357|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.5|||||TWO_SIDED|95.0|0.38|0.66|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.66|0.38|
91598358|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.42|||||TWO_SIDED|95.0|0.29|0.6|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.60|0.29|
91598359|NCT00562354|183087982|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.59|||||TWO_SIDED|95.0|0.42|0.82|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.82|0.42|
91598360|NCT00802204|183087993|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|describe.....||Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD||||<0.05
91598361|NCT00802204|183087993|OTHER||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to compare baseline and post-diet outcome measures||||<0.05
91598362|NCT02600507|183088013|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.03||0.021|TWO_SIDED|95.0|-4.42|-0.37|||Mixed Effects Model for Repeated Measure|||||-0.37|-4.42|0.021
91598363|NCT02600507|183088013|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.01||0.099|TWO_SIDED|95.0|-3.65|0.32|||Mixed Effects Model for Repeated Measure|||||0.32|-3.65|0.099
91598364|NCT02600507|183088014|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.008|TWO_SIDED|95.0|-0.59|-0.09|||Mixed Effects Model for Repeated Measure|||||-0.09|-0.59|0.008
91598365|NCT02600507|183088014|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.04|TWO_SIDED|95.0|-0.5|-0.01|||Mixed Effects Model for Repeated Measure|||||-0.01|-0.50|0.040
91598366|NCT05048719|183088015|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||||-0.40|-1.13|<0.001
91709381|NCT03749109|183311414|OTHER||Rate Ratio|0.49||||0.56|TWO_SIDED|95.0|0.04|5.41|||Negative-binomial regression|||Adenomyosis - Disappearing Lesions||5.41|0.04|0.56
91709382|NCT03749109|183311415|OTHER||Difference in LS mean|0.23||||0.97|TWO_SIDED|95.0|-12.78|13.23|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.23|-12.78|0.97
91598367|NCT05048719|183088015|SUPERIORITY||LS Mean Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-1.85|-1.12|||Mixed Models Analysis|||||-1.12|-1.85|<0.001
91598368|NCT05048719|183088015|SUPERIORITY||LS Mean Difference|-1.36|||<|0.001|TWO_SIDED|95.0|-1.75|-0.98|||Mixed Models Analysis|||||-0.98|-1.75|<0.001
91598369|NCT05048719|183088015|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-1.96|-1.25|||Mixed Models Analysis|||||-1.25|-1.96|<0.001
91709383|NCT03749109|183311415|OTHER||Difference in LS mean|0.72||||0.74|TWO_SIDED|95.0|-3.63|5.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||5.07|-3.63|0.74
91598370|NCT05048719|183088015|SUPERIORITY||LS Mean Difference|-1.67|||<|0.001|TWO_SIDED|95.0|-2.02|-1.32|||Mixed Models Analysis|||||-1.32|-2.02|<0.001
91598371|NCT05048719|183088016|SUPERIORITY||LS Mean Difference|-0.09||||0.626|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Analysis|||||0.28|-0.47|0.626
91598372|NCT05048719|183088016|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.18|-0.44|||Mixed Models Analysis|||||-0.44|-1.18|<0.001
91598373|NCT05048719|183088016|SUPERIORITY||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-1.08|-0.3|||Mixed Models Analysis|||||-0.30|-1.08|<0.001
91598374|NCT05048719|183088016|SUPERIORITY||LS Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||Mixed Models Analysis|||||-0.57|-1.29|<0.001
91598375|NCT05048719|183088016|SUPERIORITY||LS Mean Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.36|-0.64|||Mixed Models Analysis|||||-0.64|-1.36|<0.001
91598376|NCT05048719|183088017|OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|2.21|20.75|||Regression, Logistic|||||20.75|2.21|<0.001
91598377|NCT05048719|183088017|OTHER||Odds Ratio (OR)|34.09|||<|0.001|TWO_SIDED|95.0|9.92|117.16|||Regression, Logistic|||||117.16|9.92|<0.001
91598378|NCT05048719|183088017|OTHER||Odds Ratio (OR)|48.33|||<|0.001|TWO_SIDED|95.0|11.9|196.24|||Regression, Logistic|||||196.24|11.90|<0.001
91598379|NCT05048719|183088017|OTHER||Odds Ratio (OR)|45.72|||<|0.001|TWO_SIDED|95.0|13.61|153.64|||Regression, Logistic|||||153.64|13.61|<0.001
91598380|NCT05048719|183088017|OTHER||Odds Ratio (OR)|77.23|||<|0.001|TWO_SIDED|95.0|20.26|294.48|||Regression, Logistic|||||294.48|20.26|<0.001
91598381|NCT05048719|183088017|OTHER||Odds Ratio (OR)|1.22||||0.678|TWO_SIDED|95.0|0.48|3.13|||Regression, Logistic|||||3.13|0.48|0.678
91598382|NCT05048719|183088017|OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.19|17.24|||Regression, Logistic|||||17.24|2.19|<0.001
91654969|NCT03384745|183202667|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 (48.1% \[34.0-62.4\], p\<0.0001) of 52 participants in the M1095 30mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
91598383|NCT05048719|183088017|OTHER||Odds Ratio (OR)|8.71|||<|0.001|TWO_SIDED|95.0|2.55|29.79|||Regression, Logistic|||||29.79|2.55|<0.001
91598384|NCT05048719|183088017|OTHER||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|3.05|22.3|||Regression, Logistic|||||22.30|3.05|<0.001
91598385|NCT05048719|183088017|OTHER||Odds Ratio (OR)|13.93|||<|0.001|TWO_SIDED|95.0|4.51|43.01|||Regression, Logistic|||||43.01|4.51|<0.001
91598386|NCT05048719|183088018|OTHER||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|2.93|22.9|||Regression, Logistic|||||22.90|2.93|<0.001
91598387|NCT05048719|183088018|OTHER||Odds Ratio (OR)|25.02|||<|0.001|TWO_SIDED|95.0|7.57|82.69|||Regression, Logistic|||||82.69|7.57|<0.001
91598388|NCT05048719|183088018|OTHER||Odds Ratio (OR)|62.31|||<|0.001|TWO_SIDED|95.0|12.26|316.63|||Regression, Logistic|||||316.63|12.26|<0.001
91598389|NCT05048719|183088018|OTHER||Odds Ratio (OR)|67.57|||<|0.001|TWO_SIDED|95.0|17.56|259.97|||Regression, Logistic|||||259.97|17.56|<0.001
91598390|NCT05048719|183088018|OTHER||Odds Ratio (OR)|129.55|||<|0.001|TWO_SIDED|95.0|26.72|628.09|||Regression, Logistic|||||628.09|26.72|<0.001
91598391|NCT05048719|183088018|OTHER||Odds Ratio (OR)|1.13||||0.802|TWO_SIDED|95.0|0.43|2.96|||Regression, Logistic|||||2.96|0.43|0.802
91598392|NCT05048719|183088018|OTHER||Odds Ratio (OR)|3.46||||0.026|TWO_SIDED|95.0|1.16|10.31|||Regression, Logistic|||||10.31|1.16|0.026
91598393|NCT05048719|183088018|OTHER||Odds Ratio (OR)|8.61||||0.006|TWO_SIDED|95.0|1.83|40.51|||Regression, Logistic|||||40.51|1.83|0.006
91598394|NCT05048719|183088018|OTHER||Odds Ratio (OR)|9.34|||<|0.001|TWO_SIDED|95.0|2.67|32.71|||Regression, Logistic|||||32.71|2.67|<0.001
91598395|NCT05048719|183088018|OTHER||Odds Ratio (OR)|17.9|||<|0.001|TWO_SIDED|95.0|4.02|79.7|||Regression, Logistic|||||79.70|4.02|<0.001
91598396|NCT05048719|183088019|OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-32.7|-10.3|||Mixed Models Analysis|||||-10.3|-32.7|<0.001
91598397|NCT05048719|183088019|OTHER||LS Mean Difference|-42.5|||<|0.001|TWO_SIDED|95.0|-53.4|-31.7|||Mixed Models Analysis|||||-31.7|-53.4|<0.001
91598398|NCT05048719|183088019|OTHER||LS Mean Difference|-41.0|||<|0.001|TWO_SIDED|95.0|-52.7|-29.3|||Mixed Models Analysis|||||-29.3|-52.7|<0.001
91598399|NCT05048719|183088019|OTHER||LS Mean Difference|-42.7|||<|0.001|TWO_SIDED|95.0|-53.5|-32.0|||Mixed Models Analysis|||||-32.0|-53.5|<0.001
91598400|NCT05048719|183088019|OTHER||LS Mean Difference|-44.7|||<|0.001|TWO_SIDED|95.0|-55.3|-34.2|||Mixed Models Analysis|||||-34.2|-55.3|<0.001
91598401|NCT05048719|183088019|OTHER||LS Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|-10.6|11.8|||Mixed Models Analysis|||||11.8|-10.6|<0.001
91598402|NCT05048719|183088019|OTHER||LS Mean Difference|-20.5|||<|0.001|TWO_SIDED|95.0|-31.4|-9.5|||Mixed Models Analysis|||||-9.5|-31.4|<0.001
91598403|NCT05048719|183088019|OTHER||LS Mean Difference|-19.0||||0.002|TWO_SIDED|95.0|-30.7|-7.2|||Mixed Models Analysis|||||-7.2|-30.7|0.002
91598404|NCT05048719|183088019|OTHER||LS Mean Difference|-20.7|||<|0.001|TWO_SIDED|95.0|-31.4|-9.9|||Mixed Models Analysis|||||-9.9|-31.4|<0.001
91598405|NCT05048719|183088019|OTHER||LS Mean Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-33.2|-12.1|||Mixed Models Analysis|||||-12.1|-33.2|<0.001
91598406|NCT05048719|183088020|OTHER||LS Mean Difference|-1.6||||0.153|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||||0.6|-3.7|0.153
91598407|NCT05048719|183088020|OTHER||LS Mean Difference|-4.3|||<|0.001|TWO_SIDED|95.0|-6.4|-2.2|||Mixed Models Analysis|||||-2.2|-6.4|<0.001
91598408|NCT05048719|183088020|OTHER||LS Mean Difference|-7.6|||<|0.001|TWO_SIDED|95.0|-9.8|-5.3|||Mixed Models Analysis|||||-5.3|-9.8|<0.001
91598409|NCT05048719|183088020|OTHER||LS Mean Difference|-7.4|||<|0.001|TWO_SIDED|95.0|-9.4|-5.3|||Mixed Models Analysis|||||-5.3|-9.4|<0.001
91649539|NCT00803959|183191711|NON_INFERIORITY_OR_EQUIVALENCE|The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).|Difference in success % (UDS - no UDS)|-0.3|||||TWO_SIDED|95.0|-7.5|6.9|||Chi-squared|Noninferiority declared if the upper boundary of the two-sided 95% confidence interval for the difference in % success (UDS - no UDS) was \< 11%.|Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.|The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.||6.9|-7.5|
91649540|NCT00803959|183191712|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.|Chi-squared|No adjustments were made; test had 1 degree of freedom.||Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.||||0.63
91649541|NCT00803959|183191713|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|Chi-squared|No adjustments made; 1 degree of freedom test.||"Null hypothesis is that there is no difference in the proportion responding very much better or much better on the Patient Global Impression of Improvement at the 12 month visit."||||0.68
91649542|NCT00803959|183191714|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.|t-test, 2 sided|One df t test assumed equal variance; no evidence was found to the contrary.||Null hypothesis is that the two arms do not differ according to change in UDI score.||||0.68
91649543|NCT00803959|183191715|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.||Null hypothesis is that the 2 arms do not differ according to change in ISI score.||||0.40
91649544|NCT00803959|183191716|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.|t-test, 2 sided|The t test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ in change in MESA stress score.||||0.50
91649545|NCT00803959|183191717|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|The t test had 1 df and assumed equal variances; no evidence of different variances was found.||Null hypothesis is that the two arms do not differ according to change in MESA urgency score.||||0.19
91649546|NCT00803959|183191718|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05|t-test, 2 sided|T test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.||||0.49
91598410|NCT05048719|183088020|OTHER||LS Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.9|-5.9|||Mixed Models Analysis|||||-5.9|-9.9|<0.001
91649547|NCT00803959|183191719|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|T test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.||||0.02
91649548|NCT00803959|183191720|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|The t test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.||||0.51
91649549|NCT00803959|183191721|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months||||0.51
91649550|NCT00803959|183191722|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.|t-test, 2 sided|T test had 1 df and assumed equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.||||0.28
91649551|NCT00803959|183191723|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.|Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.||||0.19
91649552|NCT01859390|183191724|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.46|TWO_SIDED|95.0|-0.49|0.22|||t-test, 2 sided|||Two-sample T-test||0.22|-0.49|0.460
91649553|NCT01859390|183191724|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.325|TWO_SIDED|95.0|-0.513|0.173|||Regression, Linear||"Regression Model predictors include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1%Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The estimated value is the mean difference between groups for 16 week change in log10 MPO."|||0.173|-0.513|0.325
91598411|NCT05048719|183088020|OTHER||LS Mean Difference|0.1||||0.914|TWO_SIDED|95.0|-2.0|2.3|||Mixed Models Analysis|||||2.3|-2.0|0.914
91598412|NCT05048719|183088020|OTHER||LS Mean Difference|-2.6||||0.015|TWO_SIDED|95.0|-4.7|-0.5|||Mixed Models Analysis|||||-0.5|-4.7|0.015
91598413|NCT05048719|183088020|OTHER||LS Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.1|-3.6|||Mixed Models Analysis|||||-3.6|-8.1|<0.001
91598414|NCT05048719|183088020|OTHER||LS Mean Difference|-5.7|||<|0.001|TWO_SIDED|95.0|-7.8|-3.6|||Mixed Models Analysis|||||-3.6|-7.8|<0.001
91598415|NCT05048719|183088020|OTHER||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-8.3|-4.2|||Mixed Models Analysis|||||-4.2|-8.3|<0.001
91598416|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|849.0|||<|0.0001|TWO_SIDED|95.0|786.0|921.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||921|786|<0.0001
91598417|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1879.0|||<|0.0001|TWO_SIDED|95.0|1636.0|2112.0||Adjusted Cost Differences in Prescription Drug Costs, nonAEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2112|1636|<0.0001
91598418|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5681.0|||<|0.0001|TWO_SIDED|95.0|5257.0|6077.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||6077|5257|<0.0001
91598419|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|273.0|||<|0.0001|TWO_SIDED|95.0|251.0|295.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||295|251|<0.0001
91598420|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1021.0|||<|0.0001|TWO_SIDED|95.0|819.0|1211.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1211|819|<0.0001
91598421|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|60.0|||<|0.0001|TWO_SIDED|95.0|48.0|72.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||72|48|<0.0001
91598422|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2555.0||||0.008|TWO_SIDED|95.0|834.0|4281.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4281|834|0.0080
91598423|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4041.0|||<|0.0001|TWO_SIDED|95.0|3776.0|4305.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4305|3776|<0.0001
91598424|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|105.0|||<|0.0001|TWO_SIDED|95.0|97.0|114.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||114|97|<0.0001
91598425|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|384.0|||<|0.0001|TWO_SIDED|95.0|358.0|413.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||413|358|<0.0001
91598426|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.0|||<|0.0001|TWO_SIDED|95.0|40.0|56.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||56|40|<0.0001
91598427|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|892.0|||<|0.0001|TWO_SIDED|95.0|584.0|1192.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1192|584|<0.0001
91598428|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12258.0|||<|0.0001|TWO_SIDED|95.0|10482.0|14083.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||14083|10482|<0.0001
91649554|NCT01859390|183191725|SUPERIORITY||Difference in Proportions-SAE incidence|-12.9||||0.302|TWO_SIDED|95.0|-32.1|7.8|||Fisher Exact|||||7.8|-32.1|0.302
91649555|NCT01859390|183191726|SUPERIORITY||Rate Ratio|0.94||||0.486|TWO_SIDED|95.0|0.78|1.13|||Poisson Model|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.||1.13|0.78|0.486
91649556|NCT01859390|183191726|SUPERIORITY|Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|Rate Ratio|0.74||||0.269|TWO_SIDED|95.0|0.43|1.26|||Poisson Regression|||||1.26|0.43|0.269
91649557|NCT01859390|183191727|SUPERIORITY|Two sample T-test|Median Difference (Final Values)|1.43||||0.4463|TWO_SIDED|95.0|-2.3|5.16|||t-test, 2 sided|||||5.16|-2.30|0.4463
91598429|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|322.0|||<|0.0001|TWO_SIDED|95.0|245.0|398.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||398|245|<0.0001
91598430|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|841.0|||<|0.0001|TWO_SIDED|95.0|556.0|1078.0||Adjusted Cost Differences in Prescription Drug Costs, non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1078|556|<0.0001
91598431|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3248.0|||<|0.0001|TWO_SIDED|95.0|2790.0|3714.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3714|2790|<0.0001
91598432|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|164.0|||<|0.0001|TWO_SIDED|95.0|138.0|190.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||190|138|<0.0001
91649558|NCT01859390|183191728|SUPERIORITY||Median Difference (Final Values)|0.04||||0.8623|TWO_SIDED|95.0|-0.37|0.44|||t-test, 2 sided|||||0.44|-0.37|0.8623
91649559|NCT01859390|183191729|SUPERIORITY||Cox Proportional Hazard|0.536||||0.0534|TWO_SIDED|95.0|0.284|1.009||Not adjusted for multiple comparisons. Alpha at 0.05.|Regression, Cox||"Cox model parameters include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1 % Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm."|||1.009|0.284|0.0534
91649560|NCT01859390|183191730|SUPERIORITY||Rate Ratio|0.72||||0.1731|TWO_SIDED|95.0|0.44|1.16|||Poisson Model|||Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.||1.16|0.44|0.1731
91649561|NCT01859390|183191731|SUPERIORITY|Difference in Proportions|Mean Difference (Final Values)|-14.8||||0.2363|TWO_SIDED|95.0|-35.1|7.4||Not adjusted for multiple comparisons. Alpha at 0.05.|Fisher Exact|||||7.4|-35.1|0.2363
91649562|NCT01859390|183191732|SUPERIORITY|Difference in Proportions|Median Difference (Final Values)|-15.7||||0.19|TWO_SIDED|95.0|-34.5|4.8|||Fisher Exact|||||4.8|-34.5|0.1900
91649563|NCT01151813|183191734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||t-test, 2 sided|||||||.02
91649564|NCT01151813|183191735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91649565|NCT01151813|183191736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91649566|NCT01151813|183191737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91649567|NCT01084005|183191749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.81|-0.48|||ANCOVA|||||-0.48|-0.81|<0.0001
91784593|NCT02447302|183449769|SUPERIORITY||MH estimate for difference in percentage|7.1|STANDARD_ERROR_OF_MEAN|6.46|=|0.136|TWO_SIDED|90.0|-3.5|17.7||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.7|-3.5|= 0.1360
91598433|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|628.0|||<|0.0001|TWO_SIDED|95.0|409.0|819.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||819|409|<0.0001
91649568|NCT01084005|183191750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.45|-0.24|||ANCOVA|||||-0.24|-0.45|<0.0001
91649569|NCT01084005|183191751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.71|-0.43|||ANCOVA|||||-0.43|-0.71|<0.0001
91649570|NCT01084005|183191752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.77|-0.47|||ANCOVA|||||-0.47|-0.77|<0.0001
91649571|NCT01084005|183191753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.2|-11.2|||ANCOVA|||||-11.2|-30.2|<0.0001
91649572|NCT01084005|183191754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001||95.0|-24.7|-12.6|||Mixed Models Analysis|||||-12.6|-24.7|<0.0001
91649573|NCT01084005|183191755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-28.1|-14.8|||Mixed Models Analysis|||||-14.8|-28.1|<0.0001
91649574|NCT01084005|183191756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||95.0|-29.8|-13.4|||Mixed Models Analysis|||||-13.4|-29.8|<0.0001
91649575|NCT01084005|183191757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.319|||<|0.0001||95.0|3.321|20.837|||Regression, Logistic|||||20.837|3.321|<0.0001
91649576|NCT01084005|183191760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.214||||0.0048|TWO_SIDED|95.0|0.073|0.625|||Regression, Logistic|||Lina 5 mg qd vs Placebo||0.625|0.073|0.0048
91790453|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.185||0.921|TWO_SIDED|95.0|-0.346|0.383||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.383|-0.346|0.921
91649577|NCT00606684|183191786|SUPERIORITY_OR_OTHER||Least squares mean difference|0.092|||<|0.001|TWO_SIDED|95.0|0.039|0.144|||ANCOVA|||||0.144|0.039|<0.001
91649578|NCT00606684|183191786|SUPERIORITY_OR_OTHER||Least squares mean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.046|0.15|||ANCOVA|||||0.150|0.046|<0.001
91649579|NCT00606684|183191786|SUPERIORITY_OR_OTHER||Least squares mean difference|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.162|||ANCOVA|||||0.162|0.057|<0.001
91649580|NCT00606684|183191786|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|||<|0.001|TWO_SIDED|95.0|0.085|0.19|||ANCOVA|||||0.190|0.085|<0.001
91649581|NCT00606684|183191786|SUPERIORITY_OR_OTHER||Least squares mean difference|0.165|||<|0.001|TWO_SIDED|95.0|0.112|0.217|||ANCOVA|||||0.217|0.112|<0.001
91784594|NCT02447302|183449770|SUPERIORITY||MH estimate for difference in percentage|18.9|STANDARD_ERROR_OF_MEAN|9.92|=|0.0282|TWO_SIDED|90.0|2.6|35.3||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||35.3|2.6|= 0.0282
91598434|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||<|0.0001|TWO_SIDED|95.0|18.0|42.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||42|18|<0.0001
91649582|NCT02967133|183191795|SUPERIORITY|||||||0.5186|||||||Log Rank|||||||0.5186
91784595|NCT02447302|183449770|SUPERIORITY||MH estimate for difference in percentage|11.4|STANDARD_ERROR_OF_MEAN|10.14|=|0.1309|TWO_SIDED|90.0|-5.3|28.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||28.1|-5.3|= 0.1309
91784596|NCT01742286|183449795|OTHER||MTD/RDE|510.0||||||||||||||||||
91784597|NCT01742286|183449795|OTHER||MTD/RDE|500.0||||||||||||||||||
91784598|NCT02578095|183449838|SUPERIORITY||Mean Difference (Final Values)|4.75||||0.0032|TWO_SIDED|95.0|1.7|7.8|||ANCOVA|||||7.80|1.70|0.0032
91598435|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|235.0||||0.7628|TWO_SIDED|95.0|-1367.0|1798.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1798|-1367|0.7628
91598436|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2306.0|||<|0.0001|TWO_SIDED|95.0|2016.0|2603.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2603|2016|<0.0001
91598437|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0|||<|0.0001|TWO_SIDED|95.0|52.0|74.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||74|52|<0.0001
91598438|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.0|||<|0.0001|TWO_SIDED|95.0|179.0|245.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||245|179|<0.0001
91598439|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||<|0.0001|TWO_SIDED|95.0|15.0|33.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||33|15|<0.0001
91598440|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|277.0||||0.0581|TWO_SIDED|95.0|-19.0|581.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||581|-19|0.0581
91598441|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5437.0|||<|0.0001|TWO_SIDED|95.0|3672.0|7142.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7142|3672|<0.0001
91598442|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1019.0|||<|0.0001|TWO_SIDED|95.0|836.0|1191.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1191|836|<0.0001
91649583|NCT01828255|183191805|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
91784599|NCT02578095|183449838|SUPERIORITY||Mean Difference (Final Values)|7.15|||<|0.0001|TWO_SIDED|95.0|3.76|10.54|||ANCOVA|||||10.54|3.76|<0.0001
91784600|NCT02578095|183449838|SUPERIORITY||Mean Difference (Final Values)|9.08|||<|0.0001|TWO_SIDED|95.0|5.55|12.6|||ANCOVA|||||12.60|5.55|<0.0001
91784601|NCT05091567|183449842|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.67|||Log Rank|||Stratified Analysis: The stratification factors were Eastern Cooperative Oncology Group performance status (ECOG PS) at randomization (0 vs. 1); Lactate Dehydrogenase (LDH) at randomization (\<=upper limit of normal (ULN) vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of prophylactic cranial irradiation (PCI) (yes vs. no).||0.67|0.43|< .0001
91649584|NCT04169282|183191860|SUPERIORITY|||||||0.108|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.108
91784602|NCT05091567|183449843|SUPERIORITY||Hazard Ratio (HR)|0.73|||=|0.0174|TWO_SIDED|95.0|0.57|0.95|||Log Rank|||Stratified Analysis: The stratification factors were ECOG PS at randomization (0 vs. 1); LDH at randomization (\<=ULN vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).||0.95|0.57|= 0.0174
91784603|NCT05091567|183449844|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.45|0.68||||||Stratified Analysis: The stratification factors were ECOG PS at randomization (0 vs. 1); LDH at randomization (\<=ULN vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).||0.68|0.45|
91598443|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1047.0|||<|0.0001|TWO_SIDED|95.0|564.0|1486.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1486|564|<0.0001
91598444|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9128.0|||<|0.0001|TWO_SIDED|95.0|7346.0|11125.0||Adjusted Cost Differences in Hospitalizations|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||11125|7346|<0.0001
91598445|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|459.0|||<|0.0001|TWO_SIDED|95.0|326.0|622.0||Adjusted Cost Differences in Emergency Department Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||622|326|<0.0001
91598446|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2427.0|||<|0.0001|TWO_SIDED|95.0|1587.0|3290.0||Adjusted Cost Differences in Outpatient Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3290|1587|<0.0001
91598447|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|357.0|||<|0.0001|TWO_SIDED|95.0|225.0|525.0||Adjusted Cost Differences in Neurologists Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||525|225|<0.0001
91598448|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|502.0|||<|0.0001|TWO_SIDED|95.0|234.0|768.0||Adjusted Cost Differences in Other Healthcare Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||768|234|<0.0001
91598449|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6483.0|||<|0.0001|TWO_SIDED|95.0|5329.0|7927.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||7927|5329|<0.0001
91649585|NCT04169282|183191861|SUPERIORITY|||||||0.003|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.003
91598450|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.0|||<|0.0001|TWO_SIDED|95.0|112.0|199.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||199|112|<0.0001
91598451|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|516.0|||<|0.0001|TWO_SIDED|95.0|401.0|645.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||645|401|<0.0001
91598452|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|158.0|||<|0.0001|TWO_SIDED|95.0|97.0|231.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||231|97|<0.0001
91598453|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|83.0|||<|0.0001|TWO_SIDED|95.0|58.0|113.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||113|58|<0.0001
91598454|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14582.0|||<|0.0001|TWO_SIDED|95.0|12019.0|17097.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||17097|12019|<0.0001
91598455|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|420.0|||<|0.0001|TWO_SIDED|95.0|210.0|630.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||630|210|<0.0001
91598456|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|658.0|||<|0.0001|TWO_SIDED|95.0|217.0|1131.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1131|217|<0.0001
91598457|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6040.0|||<|0.0001|TWO_SIDED|95.0|3442.0|8795.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||8795|3442|<0.0001
91598458|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|268.0||||0.002|TWO_SIDED|95.0|81.0|425.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||425|81|0.0020
91598459|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.967|TWO_SIDED|95.0|-991.0|944.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||944|-991|0.9670
91598460|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.0||||0.2563|TWO_SIDED|95.0|-77.0|302.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||302|-77|0.2563
91598461|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|328.0||||0.01|TWO_SIDED|95.0|90.0|588.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||588|90|0.0100
91598462|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4984.0|||<|0.0001|TWO_SIDED|95.0|3168.0|7335.0||Adjusted Cost Differences in Hospitalizations, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7335|3168|<0.0001
91649586|NCT04169282|183191862|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.025
91649587|NCT01275313|183191864|EQUIVALENCE|Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.||||||0.77|||||||Chi-squared, Corrected|||Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.||||0.77
91649588|NCT00322309|183191870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that there would be no significant difference between the two treatment groups for benzoylecgonine data collected for Week 11.||||>0.05
91649589|NCT00322309|183191871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|6.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that means scores for the CGI-O would not differ significantly for these values obtained in the final treatment week, Week 11.||||>0.05
91522526|NCT01181726|182920061|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.19|||||TWO_SIDED|90.0|91.18|99.38|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.38|91.18|
91649590|NCT00322309|183191872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.4|>|0.05|TWO_SIDED|||||This analysis involves a between group comparison.|t-test, 2 sided|||It hypothesized that the two treatment groups would not differ significantly with respect to the total HAM-D scores obtained in the final week of the study (Week 11).||||>0.05
91598463|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|112.0|||<|0.0001|TWO_SIDED|95.0|70.0|166.0||Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||166|70|<0.0001
91598464|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|236.0||||0.01|TWO_SIDED|95.0|70.0|403.0||Adjusted Cost Differences in Outpatient Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||403|70|0.01
91598465|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.0||||0.1061|TWO_SIDED|95.0|-22.0|145.0||Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||145|-22|0.1061
91649591|NCT00322309|183191873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|18.0|>|0.05||95.0||||Percent of capsules administered does not differ significantly between the two groups.|t-test, 2 sided|||It was hypothesized that there would be no significant difference in the mean percentage of capsules of those dispensed between the two groups.||||>0.05
91784604|NCT05091567|183449845|SUPERIORITY||Difference in Overall Response Rates|8.99|||||TWO_SIDED|95.0|1.07|16.9||||||Stratified Analysis: The stratification factors were ECOGPS at randomization (0 vs. 1);LDH at randomization (\<=ULN vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).||16.90|1.07|
91598466|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.0|||<|0.0001|TWO_SIDED|95.0|28.0|93.0||Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||93|28|<0.0001
91598467|NCT01390909|183088035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7673.0|||<|0.0001|TWO_SIDED|95.0|4571.0|10989.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||10989|4571|<0.0001
91598468|NCT02354703|183088036|SUPERIORITY|||||||0.94||||||a priori significance P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.94
91598469|NCT02354703|183088037|SUPERIORITY|||||||1||||||a priori significance is P\<0.05|Chi-squared|adjusted for baseline value||||||1.00
91598470|NCT02354703|183088038|SUPERIORITY|||||||0.73||||||a priori threshold is P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.73
91598471|NCT03269344|183088045|SUPERIORITY|||||||0.11|||||||ANOVA|||||||0.11
91598472|NCT03269344|183088046|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91598473|NCT03269344|183088047|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91598474|NCT03269344|183088048|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91598475|NCT03269344|183088049|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
91598476|NCT03269344|183088050|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91784605|NCT05091567|183449846|SUPERIORITY||Difference in Overall Response Rates|3.9|||||TWO_SIDED|95.0|-3.51|11.32||||||Stratified Analysis: The stratification factors were ECOGPS at randomization (0 vs. 1);LDH at randomization (\<=ULNvs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).||11.32|-3.51|
91784606|NCT05091567|183449849|SUPERIORITY||Difference in Event Free Rate|22.56|||||TWO_SIDED|95.0|14.12|31.0||||||||31.00|14.12|
91784607|NCT05091567|183449849|SUPERIORITY||Difference in Event Free Rate|8.51|||||TWO_SIDED|95.0|0.72|16.31||||||||16.31|0.72|
91598477|NCT04681170|183088068|OTHER||Mean Difference (Net)|-53.91|||<|0.0001|TWO_SIDED|95.0|-61.859|-45.9612|||t-test, 1 sided|||This was a single-arm study, no comparative group can be assigned; the comparison made for the primary efficacy endpoint is done only between baseline and Week 24 in paediatric subjects (5 to ≤17 years of age). Analysis was made using the one-sample t-test to test the null hypothesis that the percentage change from Baseline was equal to zero against the alternative hypothesis that the percentage change from Baseline was not equal to zero.||-45.9612|-61.8590|<0.0001
91598478|NCT02118792|183088099|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91598479|NCT01885000|183088148|SUPERIORITY||||||=|0.0065|||||||Cochran-Mantel-Haenszel|||||||= 0.0065
91598480|NCT01885000|183088149|SUPERIORITY||||||=|0.0328|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who satisfied with appearance.||||= 0.0328
91598481|NCT01885000|183088149|SUPERIORITY||||||=|0.5312|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance acceptable.||||= 0.5312
91598482|NCT01885000|183088149|SUPERIORITY||||||=|0.0756|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance concerned.||||= 0.0756
91784608|NCT05091567|183449850|SUPERIORITY||Difference in Event Free Rate|23.65|||||TWO_SIDED|95.0|15.09|32.2||||||||32.20|15.09|
91598483|NCT01885000|183088149|SUPERIORITY||||||=|0.0083|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who embarrassed with facial redness.||||= 0.0083
91598484|NCT01885000|183088149|SUPERIORITY||||||=|0.0076|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who self-conscious.||||= 0.0076
91598485|NCT01885000|183088149|SUPERIORITY||||||=|0.2186|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who's frequency control last 24 hours||||= 0.2186
91598486|NCT01885000|183088149|SUPERIORITY||||||=|0.2373|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who are frustrated.||||= 0.2373
91598487|NCT01885000|183088149|SUPERIORITY||||||=|0.7769|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who cover up or camouflage.||||= 0.7769
91598488|NCT01885000|183088149|SUPERIORITY||||||=|0.8764|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who pay attention to the known triggers.||||= 0.8764
91598489|NCT01885000|183088149|SUPERIORITY||||||=|0.6149|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who avoid the known triggers.||||= 0.6149
91598490|NCT01885000|183088149|SUPERIORITY||||||=|0.8361|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who interfering with social life.||||= 0.8361
91598491|NCT01885000|183088149|SUPERIORITY||||||=|0.6259|||||||Cochran-Mantel-Haenszel|||Interfering with work life||||= 0.6259
91598492|NCT01885000|183088150|SUPERIORITY||||||=|0.5821|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Mobility.||||= 0.5821
91598493|NCT01885000|183088150|SUPERIORITY||||||=|0.8864|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Self-Care.||||= 0.8864
91598494|NCT01885000|183088150|SUPERIORITY||||||=|0.9579|||||||Cochran-Mantel-Haenszel|||This analysis was performed for usual activities.||||= 0.9579
91598495|NCT01885000|183088150|SUPERIORITY||||||=|0.1344|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Pain/Discomfort.||||= 0.1344
91598496|NCT01885000|183088150|SUPERIORITY||||||=|0.1881|||||||Cochran-Mantel-Haenszel|||Anxiety/Depression||||= 0.1881
91598497|NCT01885000|183088151|SUPERIORITY||||||=|0.3935|||||||Cochran-Mantel-Haenszel|||||||= 0.3935
91598498|NCT01885000|183088152|SUPERIORITY||||||=|0.4162|||||||Cochran-Mantel-Haenszel|||||||= 0.4162
91598499|NCT03716869|183088160|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.001|TWO_SIDED|95.0|1.39|3.1|||Regression, Logistic|||Statistical analysis was conducted using the intent-to-treat principle. Analysis for primary and secondary outcomes that compared universal to targeted screening was conducted using mixed effects logistic regression.||3.10|1.39|<0.001
91598500|NCT03716869|183088161|SUPERIORITY||Odds Ratio (OR)|5.92|||<|0.001|TWO_SIDED|95.0|5.07|6.93|||Regression, Logistic|||||6.93|5.07|<0.001
91598501|NCT03716869|183088163|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.49|4.38|||Regression, Logistic|||||4.38|2.49|<0.001
91784609|NCT05091567|183449850|SUPERIORITY||Difference in Event Free Rate|7.53|||||TWO_SIDED|95.0|-0.11|15.16||||||||15.16|-0.11|
91784610|NCT03054129|183449862|SUPERIORITY|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
91784611|NCT03054129|183449863|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
91784612|NCT03054129|183449864|SUPERIORITY|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||||||0.565
91784613|NCT03054129|183449865|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
91784614|NCT03054129|183449866|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
91784615|NCT03054129|183449867|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
91784616|NCT03054129|183449868|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
91784617|NCT03054129|183449869|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
91598502|NCT03716869|183088169|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.001|TWO_SIDED|95.0|6.71|10.58|||Regression, Logistic||Test of interaction terms from mixed-effects logistic regression for subgroup analyses. Information above is sex x rand group interaction for identification of MDD symptoms among females. For males, OR 4.05 (95% CI 3.26-5.03).||"Sex x rand group interaction p=0.005 for SAP confirmation of need for follow-up.~Females 4.73 (3.19-7.02) Males 2.09 (1.38-3.16)~Sex x rand group interaction p=0.37 for treatment initiation. OR is not reported due to p\>0.05."|10.58|6.71|<0.001
91598503|NCT03716869|183088169|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|6.58|11.35|||Regression, Logistic||Information above is for race/ethnicity x rand group interaction for identification of MDD symptoms for non-Hispanic white students. For non-Hispanic Black students OR 2.55 (95% CI 1.97-3.31), Hispanic 7.45 (4.98-11.17), other 12.41 (7.34-21.00).||"Race/ethnicity x rand group p=0.007 for SAP confirmation of need for follow-up. non-Hispanic white 2.24 (1.59-3.15) non-Hispanic Black 4.19 (2.03-8.65) Hispanic 10.15 (4.06-25.36) Other 12.22 (1.59-94.12)~Race/ethnicity x rand group interaction p=0.15 for treatment initiation. OR is not reported due to p\>0.05."|11.35|6.58|<0.001
91598504|NCT03716869|183088169|SUPERIORITY||Odds Ratio (OR)|5.47||||0.006|TWO_SIDED|95.0|4.65|6.44|||Regression, Logistic||Information above is location x rand group interaction for identification of MDD symptoms among urban students. For rural students and identification of depressive symptoms OR 13.60 (95% CI 7.28-25.42).||"Location x rand group interaction p=0.27 for SAP confirmation of need for follow-up. OR is not reported due to p\>0.05.~Location x rand group interaction p=0.36 for treatment initiation. OR is not reported due to p\>0.05."|6.44|4.65|0.006
91598505|NCT01789814|183088172|SUPERIORITY_OR_OTHER|||||||0.001||||||Prasugrel treatment when compared to Clopidogrel was associated with significant reduction in platelets aggregation for all plateles agonist (ADD, SFFFLRN, AYPGKF) at all measured time points.|t-test, 2 sided|||Each patient will have paired samples representing their baseline as well as an on-drug sample. The magnitude of platelet inhibition for each studied agonist will be performed utilizing mean maximal change from baseline in light transmission aggregometry. The paired samples will be analyzed using a two-tailed student's t-test. Statistical significance will be assumed to occur when p\<0.05.||||0.001
91598506|NCT01046825|183088180|SUPERIORITY|||||||0.555|||||||Log Rank|||||||0.5550
91598507|NCT01046825|183088181|SUPERIORITY|||||||0.3605|||||||Log Rank|||||||0.3605
91598508|NCT01046825|183088182|SUPERIORITY|||||||0.6181|||||||Chi-squared|||||||0.6181
91598509|NCT05215600|183088184|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
91784618|NCT03054129|183449870|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
91598510|NCT05215600|183088185|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
91598511|NCT03975647|183088250|OTHER||Hazard Ratio (HR)|0.759||||0.0163|TWO_SIDED|95.0|0.607|0.95|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.950|0.607|0.0163
91598512|NCT03975647|183088252|OTHER||Hazard Ratio (HR)|0.639||||0.0078|TWO_SIDED|95.0|0.459|0.891|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.891|0.459|0.0078
91598513|NCT03975647|183088253|OTHER|||||||0.2055|||||||Cochran-Mantel-Haenszel|||||||0.2055
91598514|NCT04868903|183088263|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1|TWO_SIDED|95.0|0.51|1.06|||Regression, Cox|Prespecified primary analysis using multivariable Cox proportional hazards regression to examine the effect of pooled moderate or high versus low dose||Pooled moderate or high versus low dose|Prespecified covariates were male sex, non-White race or Hispanic ethnicity, \>30 minutes sun exposure daily, moderate or severe insomnia, COVID-19 exposure outside work, employment, randomization date, and study site. Most covariates were binary after combining infrequent, ordinal variables. Baseline 25(OH)D level, age, and randomization date were continuous. An indicator was added for randomization after February 28, 2021 because only participants randomized after then could be active in the study when infection risk increased after Omicron arrived in Chicago about December 1, 2021. Due to differences in enrollment timing by study branch and site could affect baseline COVID-19 risk, we stratified Cox regression by study branch and site. This model satisfied proportional hazards.|1.06|0.51|0.10
91598515|NCT04868903|183088263|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.042|TWO_SIDED|95.0|0.39|0.98|||Regression, Cox|Secondary analysis using multivariable Cox proportional hazards regression to examine the effects of moderate versus low dose and high versus low dose||Moderate versus low dose|Covariates were male sex, non-White race or Hispanic ethnicity, \>30 minutes sun exposure daily, moderate or severe insomnia, COVID-19 exposure outside work, employment, randomization date, and study site. Most covariates were binary after combining infrequent, ordinal variables. Baseline 25(OH)D level, age, and randomization date were continuous. An indicator was added for randomization after February 28, 2021 because only participants randomized after then could be active in the study when infection risk increased after Omicron arrived in Chicago about December 1, 2021. Due to differences in enrollment timing by study branch and site could affect baseline COVID-19 risk, we stratified Cox regression by study branch and site. This model satisfied proportional hazards.|0.98|0.39|0.042
91649592|NCT00322309|183191874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|8.5|>|0.05||95.0|||||t-test, 2 sided|||It was hypothesized that there would not be a significant difference between the two groups in the mean percent of urines positive for riboflavin.||||>0.05
91709384|NCT03749109|183311416|OTHER||Difference in LS mean|10.13||||0.42|TWO_SIDED|95.0|-14.74|35.0|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||35.00|-14.74|0.42
91709385|NCT03749109|183311417|OTHER||Difference in LS mean|1.09||||0.1|TWO_SIDED|95.0|-0.2|2.38|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||2.38|-0.20|0.10
91784619|NCT03054129|183449871|SUPERIORITY|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||||||0.097
91784620|NCT03054129|183449872|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
91784621|NCT03054129|183449873|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91784622|NCT03054129|183449874|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
91784623|NCT03054129|183449875|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
91784624|NCT03054129|183449876|SUPERIORITY|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
91598516|NCT04868903|183088263|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.99|TWO_SIDED|95.0|0.53|1.86|||Regression, Cox|Secondary analysis using multivariable Cox proportional hazards regression to examine the effects of moderate versus low dose and high versus low dose||High versus low dose|Covariates were male sex, non-White race or Hispanic ethnicity, \>30 minutes sun exposure daily, moderate or severe insomnia, COVID-19 exposure outside work, employment, randomization date, and study site. Most covariates were binary after combining infrequent, ordinal variables. Baseline 25(OH)D level, age, and randomization date were continuous. An indicator was added for randomization after February 28, 2021 because only participants randomized after then could be active in the study when infection risk increased after Omicron arrived in Chicago about December 1, 2021. Due to differences in enrollment timing by study branch and site could affect baseline COVID-19 risk, we stratified Cox regression by study branch and site. This model satisfied proportional hazards.|1.86|0.53|0.99
91598517|NCT04868903|183088263|SUPERIORITY||Odds Ratio (OR)|0.62||||0.26|TWO_SIDED|95.0|0.27|1.43|||Regression, Logistic||Multivariable logistic regression with the prespecified covariates and study branch to examine the effect of pooled moderate or high versus low dose|Secondary analysis, pooled moderate versus low dose||1.43|0.27|0.26
91598518|NCT04868903|183088263|SUPERIORITY||Odds Ratio (OR)|0.38||||0.06|TWO_SIDED|95.0|0.13|1.04|||Regression, Logistic||Multivariable logistic regression with the prespecified covariates and study branch to examine the effects of moderate versus low dose and high versus low dose|Secondary analysis, moderate versus low dose||1.04|0.13|0.06
91598519|NCT04868903|183088263|SUPERIORITY||Odds Ratio (OR)|1.67||||0.47|TWO_SIDED|95.0|0.41|6.71|||Regression, Logistic||Multivariable logistic regression with the prespecified covariates and study branch to examine the effects of moderate versus low dose and high versus low dose|Secondary analysis, high versus low dose||6.71|0.41|0.47
91598520|NCT03735667|183088268|NON_INFERIORITY|A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.|||||||||||||||||A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).|||
91598521|NCT03092726|183088297|SUPERIORITY||LS Mean (LSM) Difference|0.06|STANDARD_ERROR_OF_MEAN|0.26||0.59|TWO_SIDED|90.0|-0.38|0.5||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Differences of least squares (LS) means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a mixed-effect, repeated measures (MMRM) model with change from baseline to each week from weeks 1 to 8 as response, treatment, center (pooled where necessary), time (study weeks 1 to 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||0.50|-0.38|0.590
91649593|NCT01165684|183191882|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently if the p-value for the one-sided test of was less than or equal to 2.5%, where D is the mean treatment difference (step-wise regimen minus basal-bolus regimen).|Estimated treatment difference, Mean|0.14||||0.088||95.0|-0.02|0.3|||Regression, Linear|||||0.30|-0.02|0.088
91649594|NCT01165684|183191883|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.55|||<|0.001||95.0|0.42|0.69|||Regression, Linear|||||0.69|0.42|<0.001
91649595|NCT01165684|183191884|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.37|||<|0.001||95.0|0.21|0.53|||Regression, Linear|||||0.53|0.21|<0.001
91649596|NCT01165684|183191885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.85|||<|0.001||95.0|4.12|11.39|||Regression, Logistic|||||11.39|4.12|<0.001
91649597|NCT01165684|183191886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38|||<|0.001||95.0|1.56|3.64|||Regression, Logistic|||||3.64|1.56|<0.001
91784625|NCT03054129|183449877|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
91522527|NCT01181726|182920062|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.23|||||TWO_SIDED|90.0|91.17|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|91.17|
91598522|NCT03092726|183088301|SUPERIORITY||Difference of percentages|-6.6||||0.874|TWO_SIDED|90.0|-18.7|5.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||5.7|-18.7|0.874
91598523|NCT03092726|183088301|SUPERIORITY||Differences of percentages|-5.6||||0.838|TWO_SIDED|90.0|-17.7|6.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||6.7|-17.7|0.838
91649598|NCT01165684|183191887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.146||95.0|0.9|2.07|||Regression, Logistic|||||2.07|0.90|0.146
91649599|NCT01165684|183191890|SUPERIORITY_OR_OTHER||Estimated Mean|0.12||||0.635||95.0|-0.37|0.6|||Regression, Linear|||||0.60|-0.37|0.635
91649600|NCT01165684|183191893|SUPERIORITY_OR_OTHER||Estimated mean|0.36||||0.046||95.0|0.01|0.71|||Regression, Linear|||||0.71|0.01|0.046
91649601|NCT01165684|183191894|SUPERIORITY_OR_OTHER||Estimated mean|-0.48||||0.228||95.0|-1.25|0.3|||Regression, Linear|||||0.30|-1.25|0.228
91649602|NCT01165684|183191895|SUPERIORITY_OR_OTHER||Estimated mean|-0.17||||0.224||95.0|-0.45|0.11|||Regression, Linear|||||0.11|-0.45|0.224
91784626|NCT03054129|183449878|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.040
91784627|NCT03054129|183449879|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
91784628|NCT03054129|183449880|SUPERIORITY|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
91784629|NCT03054129|183449881|SUPERIORITY|||||||0.129|||||||Wilcoxon (Mann-Whitney)|||||||0.129
91649603|NCT04549259|183191906|SUPERIORITY||Odds Ratio (OR)|3.23||||0.33|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.33
91649604|NCT04549259|183191906|SUPERIORITY||Odds Ratio (OR)|1.76||||0.63|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.63
91649605|NCT04549259|183191906|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
91649606|NCT04549259|183191906|SUPERIORITY||Odds Ratio (OR)|0.87||||0.9|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.90
91784630|NCT03054129|183449882|SUPERIORITY|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
91784631|NCT03054129|183449883|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
91598524|NCT03092726|183088302|SUPERIORITY||Differences of percentages|2.2||||0.412|TWO_SIDED|90.0|-10.0|14.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||14.4|-10.0|0.412
91598525|NCT03092726|183088302|SUPERIORITY||Differences of percentages|4.3||||0.269|TWO_SIDED|90.0|-7.9|16.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||16.4|-7.9|0.269
91649607|NCT04549259|183191906|OTHER|Single group change over time.|Odds Ratio (OR)|2.89||||0.38|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.38
91709386|NCT03749109|183311417|OTHER||Difference in LS mean|0.28||||0.67|TWO_SIDED|95.0|-1.02|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||1.58|-1.02|0.67
91784632|NCT03054129|183449884|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
91784633|NCT03054129|183449885|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
91784634|NCT03054129|183449886|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
91784635|NCT03054129|183449887|SUPERIORITY|||||||0.684|||||||Wilcoxon (Mann-Whitney)|||||||0.684
91784636|NCT03054129|183449888|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||0.112
91784637|NCT03054129|183449889|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91784638|NCT03054129|183449890|SUPERIORITY|||||||0.633|||||||Wilcoxon (Mann-Whitney)|||||||0.633
91784639|NCT03054129|183449891|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||||||0.736
91784640|NCT03054129|183449892|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
91784641|NCT03054129|183449893|SUPERIORITY|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
91598526|NCT03092726|183088303|SUPERIORITY||LSM Difference|-0.68|STANDARD_ERROR_OF_MEAN|2.03||0.369|TWO_SIDED|90.0|-4.05|2.68||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||2.68|-4.05|0.369
91784642|NCT03054129|183449894|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
91784643|NCT03054129|183449895|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.122
91784644|NCT03054129|183449896|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
91784645|NCT03054129|183449897|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
91598527|NCT03092726|183088303|SUPERIORITY||LSM Difference|-0.64|STANDARD_ERROR_OF_MEAN|2.34||0.393|TWO_SIDED|90.0|-4.51|3.24||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.24|-4.51|0.393
91598528|NCT03092726|183088303|SUPERIORITY||LSM Difference|0.86|STANDARD_ERROR_OF_MEAN|2.68||0.626|TWO_SIDED|90.0|-3.57|5.3|||MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.30|-3.57|0.626
91598529|NCT03092726|183088303|SUPERIORITY||LSM Difference|1.09|STANDARD_ERROR_OF_MEAN|2.57||0.664|TWO_SIDED|90.0|-3.16|5.34||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.34|-3.16|0.664
91598530|NCT03092726|183088304|SUPERIORITY||LSM Difference|0.16|STANDARD_ERROR_OF_MEAN|1.85||0.534|TWO_SIDED|90.0|-2.9|3.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.22|-2.90|0.534
91598531|NCT03092726|183088304|SUPERIORITY||LSM Difference|1.46|STANDARD_ERROR_OF_MEAN|2.08||0.758|TWO_SIDED|90.0|-1.98|4.91||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||4.91|-1.98|0.758
91598532|NCT03092726|183088304|SUPERIORITY||LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|2.57||0.745|TWO_SIDED|90.0|-2.56|5.96||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.96|-2.56|0.745
91598533|NCT03092726|183088304|SUPERIORITY||LSM Difference|1.68|STANDARD_ERROR_OF_MEAN|2.43||0.755|TWO_SIDED|90.0|-2.34|5.69||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.69|-2.34|0.755
91598534|NCT03092726|183088305|SUPERIORITY||LSM Difference|0.19|STANDARD_ERROR_OF_MEAN|0.59||0.629|TWO_SIDED|90.0|-0.78|1.17||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.17|-0.78|0.629
91598535|NCT03092726|183088305|SUPERIORITY||LSM Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.73||0.41|TWO_SIDED|90.0|-1.37|1.04||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.04|-1.37|0.410
91598536|NCT03092726|183088305|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.71||0.531|TWO_SIDED|90.0|-1.11|1.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.22|-1.11|0.531
91598537|NCT03092726|183088305|SUPERIORITY||LSM Difference|0.17|STANDARD_ERROR_OF_MEAN|0.67||0.603|TWO_SIDED|90.0|-0.93|1.28||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||1.28|-0.93|0.603
91598538|NCT03092726|183088306|SUPERIORITY||Odds Ratio (OR)|1.07||||0.811|TWO_SIDED|90.0|0.68|1.67||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 2: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.67|0.68|0.811
91709387|NCT03749109|183311417|OTHER||Difference in LS mean|0.32||||0.64|TWO_SIDED|95.0|-1.06|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||1.71|-1.06|0.64
91709388|NCT03749109|183311418|OTHER||Difference in LS mean|0.21||||0.73|TWO_SIDED|95.0|-1.02|1.44|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 1||1.44|-1.02|0.73
91598539|NCT03092726|183088306|SUPERIORITY||Odds Ratio (OR)|0.79||||0.368|TWO_SIDED|90.0|0.5|1.22||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 4: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.22|0.50|0.368
91598540|NCT03092726|183088306|SUPERIORITY||Odds Ratio (OR)|0.78||||0.357|TWO_SIDED|90.0|0.5|1.21||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 8: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.21|0.50|0.357
91598541|NCT03092726|183088306|SUPERIORITY||Odds Ratio (OR)|0.8||||0.407|TWO_SIDED|90.0|0.52|1.24||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||EOT: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.24|0.52|0.407
91598542|NCT00428974|183088314|SUPERIORITY|||||||0.031|||||||t-test, 1 sided|||12 weeks, 2mg CF101 vs. Placebo||||0.031
91598543|NCT00428974|183088315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
91598544|NCT04418765|183088325|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.9|-2.5||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 1 of testing order.|Mixed Models Analysis|||Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.||-2.5|-3.9|<0.0001
91598545|NCT04418765|183088325|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.4|-2.0||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 3 of testing order.|Mixed Models Analysis|||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.0|-3.4|<0.0001
91598546|NCT04418765|183088326|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|6.58|||<|0.0001|TWO_SIDED|95.0|4.41|10.01||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 2 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||10.01|4.41|<0.0001
91598547|NCT04418765|183088326|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|3.29|7.47||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 4 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||7.47|3.29|<0.0001
91613990|NCT00431847|183121846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3082|STANDARD_ERROR_OF_MEAN|0.3066||0.3155|TWO_SIDED|95.0|-0.2948|0.9112|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9112|-0.2948|0.3155
91784646|NCT03054129|183449898|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
91784647|NCT00843284|183449900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.16|STANDARD_DEVIATION|2.52|<|0.0001||95.0|-4.35|-3.97|||t-test, 2 sided|One sample t-test||Change from Baseline; observational study||-3.97|-4.35|<0.0001
91784648|NCT00843284|183449901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.02|STANDARD_DEVIATION|2.9|<|0.0001||95.0|-4.24|-3.8|||t-test, 2 sided|One sample t-test.||Change from baseline||-3.80|-4.24|<0.0001
91598548|NCT04418765|183088327|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.5|-3.0||Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 5a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-3.0|-4.5|<0.0001
91598549|NCT04418765|183088327|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.8|-2.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.2|-3.8|<0.0001
91598550|NCT04418765|183088328|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|11.43|||<|0.0001|TWO_SIDED|95.0|5.22|30.15||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||30.15|5.22|<0.0001
91598551|NCT04418765|183088328|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|4.16|24.35||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||24.35|4.16|<0.0001
91613655|NCT04400318|183121532|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-4.92|STANDARD_ERROR_OF_MEAN|0.798|<|0.001|TWO_SIDED|95.0|-6.5|-3.34|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of global lung UCSF mucus scoring, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction and baseline-by-visit interaction as covariates.||-3.34|-6.50|<0.001
91649608|NCT04549259|183191906|OTHER|Single group change over time.|Odds Ratio (OR)|1.25||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.78
91649609|NCT04549259|183191906|OTHER|Single group change over time.|Odds Ratio (OR)|2.32||||0.45|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.45
91709389|NCT03749109|183311418|OTHER||Difference in LS mean|0.42||||0.54|TWO_SIDED|95.0|-0.97|1.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||1.82|-0.97|0.54
91598552|NCT04418765|183088329|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-6.7|-4.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-4.2|-6.7|<0.0001
91598553|NCT04418765|183088329|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-5.0|-2.5||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-2.5|-5.0|<0.0001
91598554|NCT01926782|183088371|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-52.4|||<|0.0001|TWO_SIDED|97.5|-59.8|-45.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-45.0|-59.8|<0.0001
91598555|NCT01926782|183088371|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|97.5|-62.3|-48.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Week 21-24||-48.1|-62.3|<0.0001
91598556|NCT01926782|183088372|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-65.0|-52.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-52.4|-65.0|<0.0001
91598557|NCT01926782|183088372|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-65.0|||<|0.0001|TWO_SIDED|97.5|-70.4|-59.5||Threshold for significance ≤ 0.025|Mixed Models Analysis|||Week 21-24||-59.5|-70.4|< 0.0001
91598558|NCT01926782|183088373|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.0|||<|0.0001|TWO_SIDED|97.5|-64.6|-53.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-53.4|-64.6|<0.0001
91598559|NCT01926782|183088374|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.0|||<|0.0001|TWO_SIDED|97.5|-67.7|-56.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.2|-67.7|<0.0001
91598560|NCT01926782|183088375|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-64.5|-53.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.0|-64.5|<0.0001
91598561|NCT01926782|183088376|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.3|||<|0.0001|TWO_SIDED|97.5|-62.3|-50.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.3|-62.3|<0.0001
91598562|NCT01926782|183088377|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.5|||<|0.0001|TWO_SIDED|97.5|-65.0|-54.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.1|-65.0|<0.0001
91598563|NCT01926782|183088378|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.4|||<|0.0001|TWO_SIDED|97.5|-64.8|-54.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.0|-64.8|<0.0001
91598564|NCT01926782|183088379|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-45.8|-33.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.1|-45.8|<0.0001
91598565|NCT01926782|183088380|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.2|||<|0.0001|TWO_SIDED|97.5|-53.2|-43.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-53.2|<0.0001
91598566|NCT01926782|183088381|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|97.5|-49.9|-39.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.1|-49.9|<0.0001
91598567|NCT01926782|183088382|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.3|||<|0.0001|TWO_SIDED|97.5|-55.0|-45.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-45.6|-55.0|<0.0001
91598568|NCT01926782|183088383|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.9|-36.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.2|-49.9|<0.0001
91598569|NCT01926782|183088384|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|97.5|-55.3|-44.8||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.8|-55.3|<0.0001
91598570|NCT01926782|183088385|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|97.5|-54.8|-43.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-54.8|<0.0001
91598571|NCT01926782|183088386|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|97.5|-57.6|-47.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.9|-57.6|<0.0001
91598572|NCT01926782|183088387|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|97.5|-36.6|-26.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.3|-36.6|<0.0001
91598573|NCT01926782|183088388|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|97.5|-38.9|-31.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.1|-38.9|<0.0001
91598574|NCT01926782|183088389|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|97.5|-49.0|-39.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.2|-49.0|<0.0001
91598575|NCT01926782|183088390|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|97.5|-49.7|-39.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.9|-49.7|<0.0001
91649610|NCT04549259|183191906|OTHER|Single group change over time.|Odds Ratio (OR)|0.92||||0.91|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.91
91598576|NCT01926782|183088391|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.5|||<|0.0001|TWO_SIDED|97.5|-54.5|-44.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-54.5|<0.0001
91598577|NCT01926782|183088392|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|97.5|-52.2|-42.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.0|-52.2|<0.0001
91598578|NCT01926782|183088393|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.4|||<|0.0001|TWO_SIDED|97.5|-40.4|-32.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.4|-40.4|<0.0001
91709390|NCT03749109|183311418|OTHER||Difference in LS mean|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 3||0.85|-1.86|0.46
91598579|NCT01926782|183088394|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|97.5|-36.5|-29.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.1|-36.5|<0.0001
91598580|NCT01926782|183088395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|68.0|||<|0.0001|TWO_SIDED|97.5|20.9|221.0||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||221.0|20.9|<0.0001
91709391|NCT03749109|183311418|OTHER||Difference in LS mean|0.53||||0.49|TWO_SIDED|95.0|-0.99|2.05|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||2.05|-0.99|0.49
91598581|NCT01926782|183088396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.6|||<|0.0001|TWO_SIDED|97.5|13.7|47.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||47.8|13.7|<0.0001
91598582|NCT01926782|183088397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.2|||<|0.0001|TWO_SIDED|97.5|56.7|1385.7||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1385.7|56.7|<0.0001
91598583|NCT01926782|183088398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|20.3|83.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model||83.8|20.3|<0.0001
91598584|NCT01926782|183088399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|90.6|||<|0.0001|TWO_SIDED|97.5|16.5|498.3||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||498.3|16.5|<0.0001
91598585|NCT01926782|183088400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.5|||<|0.0001|TWO_SIDED|97.5|23.4|104.4||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||104.4|23.4|<0.0001
91598586|NCT01926782|183088401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|297.1|||<|0.0001|TWO_SIDED|97.5|27.9|3160.6||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||3160.6|27.9|<0.0001
91598587|NCT01926782|183088402|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.7|||<|0.0001|TWO_SIDED|97.5|34.1|176.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||176.8|34.1|<0.0001
91598588|NCT01926782|183088403|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.7|||<|0.0001|TWO_SIDED|97.5|-37.0|-18.3||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-18.3|-37.0|<0.0001
91598589|NCT01926782|183088404|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.1|||<|0.0001|TWO_SIDED|97.5|-35.5|-22.7||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-22.7|-35.5|<0.0001
91598590|NCT01926782|183088405|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.5|||<|0.0001|TWO_SIDED|97.5|-32.4|-14.5||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.5|-32.4|<0.0001
91598591|NCT01926782|183088406|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.6|||<|0.0001|TWO_SIDED|97.5|-32.8|-20.4||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-20.4|-32.8|<0.0001
91598592|NCT01926782|183088407|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0003|TWO_SIDED|97.5|3.1|12.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.6|3.1|0.0003
91598593|NCT01926782|183088408|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1||||0.0004|TWO_SIDED|97.5|1.9|8.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.4|1.9|0.0004
91598594|NCT01926782|183088409|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.0004|TWO_SIDED|97.5|2.6|11.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||11.1|2.6|0.0004
91598595|NCT01926782|183088410|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0007|TWO_SIDED|97.5|1.8|8.7||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.7|1.8|0.0007
91598596|NCT01926782|183088411|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.9||||0.0042|TWO_SIDED|97.5|-21.3|-2.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-2.6|-21.3|0.0042
91598597|NCT01926782|183088412|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.1|||<|0.0001|TWO_SIDED|97.5|-21.5|-8.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-8.6|-21.5|<0.0001
91598598|NCT01926782|183088413|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1||||0.0004|TWO_SIDED|97.5|-22.9|-5.2||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.2|-22.9|0.0004
91598599|NCT01926782|183088414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.6|||<|0.0001|TWO_SIDED|97.5|-20.3|-6.9||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-6.9|-20.3|<0.0001
91598600|NCT01926782|183088415|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6|||<|0.0001|TWO_SIDED|97.5|3.0|10.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|3.0|<0.0001
91598601|NCT01926782|183088416|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0306|TWO_SIDED|97.5|-0.1|5.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis||Alirocumab 300 mg vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.4|-0.1|0.0306
91598602|NCT02296242|183088425|OTHER||Highest dose (mg) with no DLTs.|600.0|||||TWO_SIDED|||||||||In Part 1, 2 patients experienced DLTs in the 750 mg b.i.d. treatment group (2/7; 29%). There were no dose-limiting toxicities in the 600 mg b.i.d. group or 300 mg b.i.d. group. Therefore, based on these results, 600 mg b.i.d. was selected as the MTD dose (and RP2D dose) which was used as the treatment dose in Part 2 of the study.||||
91598603|NCT03504397|183088438|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0024|TWO_SIDED|95.0|0.591|0.91||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.910|0.591|0.0024
91598604|NCT03504397|183088439|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.0075|TWO_SIDED|95.0|0.644|0.954||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.954|0.644|0.0075
91709392|NCT03749109|183311418|OTHER||Difference in LS mean|-0.01||||0.99|TWO_SIDED|95.0|-1.32|1.3|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 1||1.30|-1.32|0.99
91598605|NCT03504397|183088440|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.028|TWO_SIDED|95.0|0.994|1.687||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.687|0.994|0.0280
91598606|NCT03504397|183088441|SUPERIORITY||Hazard Ratio (HR)|0.713||||0.0508|TWO_SIDED|95.0|0.475|1.071||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.071|0.475|0.0508
91598607|NCT03504397|183088442|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.1685|TWO_SIDED|95.0|0.874|1.492|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.492|0.874|0.1685
91598608|NCT03504397|183088443|SUPERIORITY|||||||0.4536|||||||Cochran-Mantel-Haenszel|Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.||||||0.4536
91598609|NCT03504397|183088444|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.0721|TWO_SIDED|95.0|0.573|1.087|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.087|0.573|0.0721
91598610|NCT00419380|183088465|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Chi-squared|||Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.||||.36
91598611|NCT00419380|183088466|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Two by two contingency table was used to compare our outcome, presence/absence of ear drainage, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|Chi-squared|||||||.26
91598612|NCT03099707|183088467|SUPERIORITY||Risk Ratio (RR)|5.2||||0.105|TWO_SIDED|95.0|0.6|43.0|||Fisher Exact|||||43|0.6|0.105
91598613|NCT04417894|183088520|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|||||||=0.0030
91598614|NCT04417894|183088521|SUPERIORITY||Difference|38.6|||<|0.0001|TWO_SIDED|95.0|24.06|53.15|||Mantel Haenszel|||||53.15|24.06|<0.0001
91598615|NCT00262873|183088542|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91598616|NCT00262873|183088543|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91598617|NCT00262873|183088544|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91598618|NCT00844753|183088548|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
91598619|NCT00844753|183088549|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Chi-squared|||||||0.95
91598620|NCT04036968|183088550|SUPERIORITY|Comparison of three drug conditions with cannabidiol to control groups placebo+placebo and hydromorphone+placebo||||||0.195|||||||ANOVA|||||||0.195
91598621|NCT04036968|183088551|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91598622|NCT04036968|183088552|SUPERIORITY|||||||0.074|||||||ANOVA|||||||0.074
91598623|NCT00903175|183088553|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective was to assess the non-inferiority of everolimus as compared to Sunitinib in terms of PFS-1L \& was based on Bayesian methodology. If the estimated HR for PFS-1L had a value ≤ 1.1, non-inferiority of everolimus to Sunitinib would be declared. Non-inferiority of everolimus compared with Sunitinib as a first-line therapy was not achieved. The estimated HR for PFS-1L was 1.43 which did not satisfy the protocol-defined non-inferiority margin of a HR ≤ 1.1.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.15|1.77||||||||1.77|1.15|
91598624|NCT02189850|183088576|SUPERIORITY|||||||0.923|||||||Cochran-Mantel-Haenszel|||||||0.923
91709393|NCT03749109|183311418|OTHER||Difference in LS mean|0.17||||0.83|TWO_SIDED|95.0|-1.38|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||1.71|-1.38|0.83
91598625|NCT00371865|183088577|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||.27
91598626|NCT00371865|183088578|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
91598627|NCT00371865|183088579|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||.13
91598628|NCT00371865|183088580|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||.26
91598629|NCT00371865|183088581|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
91598630|NCT04179175|183088591|OTHER||Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.59|1.29|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.29|0.59|0.250
91598631|NCT04179175|183088591|OTHER||Hazard Ratio (HR)|0.7||||0.044|TWO_SIDED|95.0|0.47|1.05|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.05|0.47|0.044
91598632|NCT01696435|183088594|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.62|TWO_SIDED|95.0|0.87|1.09||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.09|.87|0.62
91598633|NCT01696435|183088594|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.03|TWO_SIDED|95.0|1.01|1.26||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.26|1.01|0.03
91598634|NCT01696435|183088595|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.05|-0.04|
91598635|NCT01696435|183088595|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.07|-0.01|
91598636|NCT01696435|183088596|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.13|0.87|0.88
91709394|NCT03749109|183311418|OTHER||Difference in LS mean|-0.74||||0.28|TWO_SIDED|95.0|-2.11|0.63|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 3||0.63|-2.11|0.28
91598637|NCT01696435|183088596|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.02|TWO_SIDED|95.0|1.03|1.33||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.33|1.03|0.02
91598638|NCT01696435|183088597|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.67|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.19|0.76|0.67
91598639|NCT01696435|183088597|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.27|0.82|0.88
91709395|NCT03749109|183311418|OTHER||Difference in LS mean|0.75||||0.26|TWO_SIDED|95.0|-0.57|2.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||2.07|-0.57|0.26
91598640|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.047||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.||||0.047
91598641|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.549||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.||||0.549
91709396|NCT03749109|183311418|OTHER||Difference in LS mean|0.91||||0.19|TWO_SIDED|95.0|-0.49|2.31|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 1||2.31|-0.49|0.19
91709397|NCT03749109|183311418|OTHER||Difference in LS mean|0.07||||0.93|TWO_SIDED|95.0|-1.45|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||1.58|-1.45|0.93
91598642|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.511||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.||||0.511
91598643|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.031||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.||||0.031
91598644|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.483||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.||||0.483
91598645|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.53||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.||||0.530
91598646|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.421||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.||||0.421
91598647|NCT01745146|183088673|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.332||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.||||0.332
91598648|NCT04316585|183088674|SUPERIORITY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-9.19|8.28|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|Bayesian logistic regression. An informative prior was used for the placebo response in this statistical analysis, the prior for placebo response rate was of the form: 90% weight on Be (5.39, 69) and 10% on Be (1/3,1/3). The prior was derived from historical data from similar clinical trials using meta-analytic predictive prior (MAP) approach. All other parameters took vague priors.||8.28|-9.19|
91598649|NCT04316585|183088674|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-4.81|8.07|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|||8.07|-4.81|
91649611|NCT04549259|183191907|SUPERIORITY||B|2.58|STANDARD_ERROR_OF_MEAN|2.8||0.36|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.36
91649612|NCT04549259|183191907|SUPERIORITY||B|-0.42|STANDARD_ERROR_OF_MEAN|2.78||0.88|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.88
91784649|NCT00109590|183449919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.||||0.009
91790454|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91649613|NCT04549259|183191907|SUPERIORITY||B|0.38|STANDARD_ERROR_OF_MEAN|2.8||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
91649614|NCT04549259|183191907|SUPERIORITY||B|-0.99|STANDARD_ERROR_OF_MEAN|2.78||0.73|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.73
91709398|NCT03749109|183311418|OTHER||Difference in LS mean|-0.13||||0.85|TWO_SIDED|95.0|-1.58|1.32|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 3||1.32|-1.58|0.85
91709399|NCT03749109|183311418|OTHER||Difference in LS mean|0.01||||0.99|TWO_SIDED|95.0|-1.68|1.69|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||1.69|-1.68|0.99
91709400|NCT03749109|183311419|OTHER||Difference in LS mean|-7.35||||0.75|TWO_SIDED|95.0|-53.97|39.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||39.27|-53.97|0.75
91522528|NCT01181726|182920063|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.92|||||TWO_SIDED|90.0|93.44|102.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.61|93.44|
91522529|NCT01181726|182920064|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.77|||||TWO_SIDED|90.0|93.92|101.78|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.78|93.92|
91522530|NCT01181726|182920065|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.71|||||TWO_SIDED|90.0|94.42|105.3|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||105.30|94.42|
91522531|NCT01181726|182920066|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.19|||||TWO_SIDED|90.0|94.71|103.87|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.87|94.71|
91522532|NCT01181726|182920067|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.83|||||TWO_SIDED|90.0|94.55|101.21|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.21|94.55|
91522533|NCT01181726|182920068|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.01|||||TWO_SIDED|90.0|94.54|101.6|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.60|94.54|
91522534|NCT01181726|182920069|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.87|||||TWO_SIDED|90.0|93.22|102.74|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.74|93.22|
91598650|NCT00130832|183088686|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.5|||<|0.001||95.0|-2.2|1.4|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 1||1.4|-2.2|<0.001
91598651|NCT00130832|183088686|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|0.0|||<|0.001||95.0|-1.4|1.6|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 2||1.6|-1.4|<0.001
91598652|NCT00130832|183088686|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.1|||<|0.001||95.0|-2.3|2.3|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 3||2.3|-2.3|<0.001
91598653|NCT00130832|183088687|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.|GMT Ratio|0.54||||0.277||95.0|0.42|0.69|||ANOVA|ANOVA model on log titer of serum anti-rotavirus IgA||||0.69|0.42|0.277
91598654|NCT00130832|183088687|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.|Percentage Point Difference|-4.4||||0.002||95.0|-8.0|-1.4|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.|Percentage point difference (concomitant - staggered)|||-1.4|-8.0|0.002
91598655|NCT03195517|183088689|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598656|NCT03195517|183088690|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598657|NCT03195517|183088691|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598658|NCT03195517|183088692|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598659|NCT03195517|183088693|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598660|NCT03195517|183088694|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598661|NCT03195517|183088695|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598662|NCT03195517|183088696|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598663|NCT03195517|183088697|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598664|NCT03195517|183088698|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91598665|NCT03118297|183088700|SUPERIORITY|||||||0.002||||||Threshold for significance: p=0.05|Wilcoxon (Mann-Whitney)|||||||0.002
91598666|NCT03118297|183088701|SUPERIORITY|||||||0.032||||||Threshold for significance: p=0.05|Fisher Exact|||||||0.032
91598667|NCT03118297|183088702|SUPERIORITY||||||<|0.001||||||Threshold for significance: p=0.05|Fisher Exact|||||||<0.001
91598668|NCT03118297|183088703|SUPERIORITY||||||>|0.05||||||Threshold for significance: p=0.05|Chi-squared|||||||>0.05
91598669|NCT03118297|183088704|OTHER|No statistical test performed|||||||||||||||||Significance testing not performed. All values below prespecified limit of 5.0 ng/mL.|||
91598670|NCT01121393|183088710|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
91598671|NCT01121393|183088710|SUPERIORITY||Hazard Ratio (HR)|0.281|||||TWO_SIDED|95.0|0.203|0.389||||||A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.||0.389|0.203|
91598672|NCT01121393|183088711|SUPERIORITY||Odds Ratio (OR)|7.572|||<|0.0001|TWO_SIDED|95.0|4.522|12.679|||Regression, Logistic|||A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.||12.679|4.522|<0.0001
91598673|NCT01121393|183088712|SUPERIORITY||Odds Ratio (OR)|3.843|||<|0.0001|TWO_SIDED|95.0|2.039|7.24|||Regression, Logistic|||stratified for EGFR mutation group||7.240|2.039|<0.0001
91598674|NCT01121393|183088713|SUPERIORITY|||||||0.4013|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||||0.4013
91598675|NCT01121393|183088713|SUPERIORITY||Hazard Ratio (HR)|0.904|||||TWO_SIDED|95.0|0.715|1.144||||||A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||1.144|0.715|
91598676|NCT01121393|183088717|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-17.1|-10.19|||ANCOVA|adjusted for baseline sum of diameters and EGFR mutation group||||-10.19|-17.10|<0.0001
91598677|NCT01121393|183088720|SUPERIORITY|||||||0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0001
91598678|NCT01121393|183088720|SUPERIORITY||Hazard Ratio (HR)|0.458|||||TWO_SIDED|95.0|0.303|0.692||||||Cox proportional hazard model stratified by EGFR mutation group||0.692|0.303|
91598679|NCT01121393|183088721|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
91649615|NCT04549259|183191907|OTHER|Single group change over time.|B|4.88|STANDARD_ERROR_OF_MEAN|1.83||0.01|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.01
91649616|NCT04549259|183191907|OTHER|Single group change over time.|B|3.28|STANDARD_ERROR_OF_MEAN|2.03||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
91649617|NCT04549259|183191907|OTHER|Single group change over time.|B|3.82|STANDARD_ERROR_OF_MEAN|2.06||0.08|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.08
91649618|NCT04549259|183191907|OTHER|Single group change over time.|B|3.19|STANDARD_ERROR_OF_MEAN|1.99||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
91649619|NCT04549259|183191908|SUPERIORITY||Odds Ratio (OR)|22.3||||0.049|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.049
91649620|NCT04549259|183191908|SUPERIORITY||Odds Ratio (OR)|1.86||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
91784650|NCT00109590|183449919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|Wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum||||0.048
91784651|NCT01129583|183449939|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
91784652|NCT01129583|183449940|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
91784653|NCT01129583|183449941|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
91784654|NCT04672954|183449947|OTHER||Ratio|1.29||||0.3941|TWO_SIDED|90.0|0.78|2.13|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.34|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.13|0.78|0.3941
91790455|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.211||0.163|TWO_SIDED|95.0|-0.711|0.12||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.120|-0.711|0.163
91790456|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790457|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.205||0.424|TWO_SIDED|95.0|-0.567|0.239||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.239|-0.567|0.424
91790458|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790459|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.213||0.664|TWO_SIDED|95.0|-0.51|0.326||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.326|-0.510|0.664
91598680|NCT01121393|183088721|SUPERIORITY||Hazard Ratio (HR)|0.534|||||TWO_SIDED|95.0|0.394|0.724||||||Cox proportional hazard model stratified by EGFR mutation group||0.724|0.394|
91598681|NCT01121393|183088722|SUPERIORITY|||||||0.022|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0220
91598682|NCT01121393|183088722|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.511|0.956||||||Cox proportional hazard model stratified by EGFR mutation group||0.956|0.511|
91598683|NCT03988335|183088732|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2-sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.24|||||||Hochberg's method|||||||0.24
91598684|NCT03988335|183088733|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.804|||||||Hochberg's method|||||||0.804
91598685|NCT01077973|183088743|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|-1.12||||0.299|TWO_SIDED|95.0|-3.23|1.0||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.00|-3.23|0.299
91598686|NCT01077973|183088744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.193|TWO_SIDED|95.0|0.52|1.14||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.14|0.52|0.193
91598687|NCT01077973|183088745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.304|TWO_SIDED|95.0|0.5|1.24||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.24|0.50|0.304
91598688|NCT01077973|183088745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.936|TWO_SIDED|95.0|0.65|1.59||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.59|0.65|0.936
91598689|NCT01077973|183088746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.072|TWO_SIDED|95.0|0.41|1.04||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.04|0.41|0.072
91598690|NCT01077973|183088746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.652|TWO_SIDED|95.0|0.58|1.41||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.41|0.58|0.652
91598691|NCT01077973|183088746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.108|TWO_SIDED|95.0|0.49|1.07||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.07|0.49|0.108
91598692|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.402|TWO_SIDED|95.0|-0.65|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.65|0.402
91598693|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.407|TWO_SIDED|95.0|-0.64|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.64|0.407
91598694|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.38|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.38|0.991
91709401|NCT03749109|183311419|OTHER||Difference in LS mean|17.31||||0.42|TWO_SIDED|95.0|-25.41|60.04|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||60.04|-25.41|0.42
91709402|NCT03749109|183311419|OTHER||Difference in LS mean|-17.66||||0.47|TWO_SIDED|95.0|-66.3|30.98|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||30.98|-66.30|0.47
91790460|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91598695|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.313|TWO_SIDED|95.0|-0.75|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.75|0.313
91649621|NCT04549259|183191908|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
91649622|NCT04549259|183191908|SUPERIORITY||Odds Ratio (OR)|0.43||||0.54|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.54
91649623|NCT04549259|183191908|OTHER|Single group change over time.|Odds Ratio (OR)|6.26||||0.09|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.09
91649624|NCT04549259|183191908|OTHER|Single group change over time.|Odds Ratio (OR)|2.05||||0.4|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.40
91784655|NCT04672954|183449947|OTHER||Ratio|1.66||||0.1089|TWO_SIDED|90.0|0.99|2.79|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.35|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.79|0.99|0.1089
91790461|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.229||0.417|TWO_SIDED|95.0|-0.638|0.265||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.265|-0.638|0.417
91598696|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.621|TWO_SIDED|95.0|-0.62|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.62|0.621
91598697|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.533|TWO_SIDED|95.0|-0.54|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.54|0.533
91598698|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.352|TWO_SIDED|95.0|-0.79|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.79|0.352
91649625|NCT04549259|183191908|OTHER|Single group change over time.|Odds Ratio (OR)|1.42||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.66
91598699|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.573|TWO_SIDED|95.0|-0.69|0.38||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.69|0.573
91598700|NCT01077973|183088747|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.657|TWO_SIDED|95.0|-0.54|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-0.54|0.657
91784656|NCT04672954|183449947|OTHER||Ratio|1.14||||0.6308|TWO_SIDED|90.0|0.71|1.85|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.32|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||1.85|0.71|0.6308
91784657|NCT04672954|183449947|OTHER||Ratio|1.75||||0.069|TWO_SIDED|90.0|1.06|2.89|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.33|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.89|1.06|0.0690
91784658|NCT03861988|183449962|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
91784659|NCT02617485|183449970|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0406|||||TWO_SIDED|90.0|0.9565|1.1321||||||Estimated Geo LS-means ratio.||1.1321|0.9565|
91598701|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.382|TWO_SIDED|95.0|-0.36|0.14||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.36|0.382
91598702|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.242|TWO_SIDED|95.0|-0.39|0.1||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.10|-0.39|0.242
91598703|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|0.04||||0.72|TWO_SIDED|95.0|-0.17|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.17|0.720
91598704|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.235|TWO_SIDED|95.0|-0.43|0.11||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.11|-0.43|0.235
91598705|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.63|TWO_SIDED|95.0|-0.34|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.34|0.630
91784660|NCT02617485|183449971|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0611|||||TWO_SIDED|90.0|0.9822|1.1464||||||Estimated Geo LS-means ratio.||1.1464|0.9822|
91784661|NCT00669409|183449995|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-17.8|13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.8|-17.8|
91598706|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.393|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.393
91598707|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.382|TWO_SIDED|95.0|-0.46|0.18||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.46|0.382
91598708|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.995|TWO_SIDED|95.0|-0.32|0.32||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.32|-0.32|0.995
91598709|NCT01077973|183088748|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.287|TWO_SIDED|95.0|-0.41|0.12||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.12|-0.41|0.287
91784662|NCT00669409|183449995|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
91784663|NCT00669409|183449995|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.1|-18.5|
91598710|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.377|TWO_SIDED|95.0|-0.98|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.98|0.377
91598711|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.324|TWO_SIDED|95.0|-1.01|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.01|0.324
91598712|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.902|TWO_SIDED|95.0|-0.52|0.59||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.52|0.902
91598713|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.273|TWO_SIDED|95.0|-1.17|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-1.17|0.273
91598714|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.616|TWO_SIDED|95.0|-0.94|0.56||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.94|0.616
91598715|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.471|TWO_SIDED|95.0|-0.85|0.39||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.39|-0.85|0.471
91598716|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.356|TWO_SIDED|95.0|-1.24|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.24|0.356
91598717|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.722|TWO_SIDED|95.0|-1.0|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-1.00|0.722
91649626|NCT04549259|183191908|OTHER|Single group change over time.|Odds Ratio (OR)|1.14||||0.87|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.87
91709403|NCT03749109|183311419|OTHER||Difference in LS mean|25.61||||0.27|TWO_SIDED|95.0|-21.05|72.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||72.27|-21.05|0.27
91598718|NCT01077973|183088749|SUPERIORITY_OR_OTHER||LS mean difference|-0.24||||0.493|TWO_SIDED|95.0|-0.94|0.46||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|-0.94|0.493
91598719|NCT01077973|183088750|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.259|TWO_SIDED|95.0|-0.75|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.75|0.259
91598720|NCT01077973|183088750|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.378|TWO_SIDED|95.0|-0.69|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.69|0.378
91598721|NCT01077973|183088750|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.762|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.45|0.762
91709404|NCT03749109|183311419|OTHER||Difference in LS mean|-20.95||||0.41|TWO_SIDED|95.0|-71.83|29.92|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||29.92|-71.83|0.41
91709405|NCT03749109|183311419|OTHER||Difference in LS mean|2.25||||0.93|TWO_SIDED|95.0|-49.57|54.06|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||54.06|-49.57|0.93
91649627|NCT04549259|183191909|SUPERIORITY||B|-1.74|STANDARD_ERROR_OF_MEAN|1.47||0.24|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.24
91649628|NCT04549259|183191909|SUPERIORITY||B|-2.05|STANDARD_ERROR_OF_MEAN|1.46||0.17|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.17
91649629|NCT04549259|183191909|SUPERIORITY||B|0.64|STANDARD_ERROR_OF_MEAN|1.47||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
91649630|NCT04549259|183191909|SUPERIORITY||B|-0.21|STANDARD_ERROR_OF_MEAN|1.46||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
91598722|NCT01077973|183088750|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.281|TWO_SIDED|95.0|-1.17|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.17|0.281
91598723|NCT01077973|183088750|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.582|TWO_SIDED|95.0|-0.97|0.55||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|-0.97|0.582
91598724|NCT01077973|183088750|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.523|TWO_SIDED|95.0|-0.83|0.42||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|-0.83|0.523
91598725|NCT01077973|183088751|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.327|TWO_SIDED|95.0|-1.35|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.35|0.327
91784664|NCT00669409|183449995|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-29.4|1.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.8|-29.4|
91784665|NCT00669409|183449995|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-55.2|-13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.7|-55.2|
91784666|NCT00669409|183449996|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
91598726|NCT01077973|183088751|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.489|TWO_SIDED|95.0|-1.21|0.58||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|-1.21|0.489
91598727|NCT01077973|183088751|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.726|TWO_SIDED|95.0|-0.88|0.61||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.61|-0.88|0.726
91598728|NCT01077973|183088751|SUPERIORITY_OR_OTHER||LS mean difference|-0.7||||0.32|TWO_SIDED|95.0|-2.09|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-2.09|0.320
91598729|NCT01077973|183088751|SUPERIORITY_OR_OTHER||LS mean difference|-0.47||||0.506|TWO_SIDED|95.0|-1.86|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.86|0.506
91598730|NCT01077973|183088751|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.691|TWO_SIDED|95.0|-1.38|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.38|0.691
91784667|NCT00669409|183449996|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.8|0.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.8|
91598731|NCT01077973|183088752|SUPERIORITY_OR_OTHER||LS mean difference|-0.72||||0.292|TWO_SIDED|95.0|-2.07|0.62||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|-2.07|0.292
91598732|NCT01077973|183088752|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.439|TWO_SIDED|95.0|-1.87|0.82||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-1.87|0.439
91598733|NCT01077973|183088752|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.733|TWO_SIDED|95.0|-1.31|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.31|0.733
91598734|NCT01077973|183088752|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.526|TWO_SIDED|95.0|-2.8|1.43||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.43|-2.80|0.526
91598735|NCT01077973|183088752|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.624|TWO_SIDED|95.0|-2.19|1.31||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|-2.19|0.624
91598736|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|3.02||||0.672|TWO_SIDED|95.0|-11.03|17.07||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||17.07|-11.03|0.672
91598737|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-4.47||||0.467|TWO_SIDED|95.0|-17.61|8.68||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.68|-17.61|0.467
91598738|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|7.55||||0.164|TWO_SIDED|95.0|-2.96|18.05||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.05|-2.96|0.164
91598739|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-7.52||||0.427|TWO_SIDED|95.0|-25.96|10.92||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.92|-25.96|0.427
91598740|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-5.66||||0.537|TWO_SIDED|95.0|-23.57|12.25||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.25|-23.57|0.537
91598741|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-1.83||||0.813|TWO_SIDED|95.0|-16.88|13.22||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.22|-16.88|0.813
91709406|NCT03951753|183311456|OTHER||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|0.87|1.29|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.29|0.87|<0.001
91784668|NCT00669409|183449996|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.7|19.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.9|-11.7|
91598742|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.455|TWO_SIDED|95.0|-19.24|8.24||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.24|-19.24|0.455
91598743|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-4.02||||0.57|TWO_SIDED|95.0|-17.63|9.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.59|-17.63|0.570
91598744|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.792|TWO_SIDED|95.0|-13.8|10.5||p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-13.80|0.792
91598745|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
91598746|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
91598747|NCT01077973|183088753|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
91598748|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|6.06||||0.48|TWO_SIDED|95.0|-10.86|22.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.99|-10.86|0.480
91598749|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|4.34||||0.612|TWO_SIDED|95.0|-12.55|21.23||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.23|-12.55|0.612
91598750|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|1.47||||0.839|TWO_SIDED|95.0|-12.6|15.55||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.55|-12.60|0.839
91598751|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-13.2||||0.13|TWO_SIDED|95.0|-29.4|2.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.99|-29.40|0.130
91598752|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-7.83||||0.331|TWO_SIDED|95.0|-23.39|7.73||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.73|-23.39|0.331
91598753|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.45|TWO_SIDED|95.0|-19.59|8.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.59|-19.59|0.450
91598754|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
91598755|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
91784669|NCT00669409|183449996|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.6|4.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.6|-26.6|
91649631|NCT04549259|183191909|OTHER|Single group change over time.|B|-1.6|STANDARD_ERROR_OF_MEAN|0.75||0.045|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.045
91649632|NCT04549259|183191909|OTHER|Single group change over time.|B|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.07|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.07
91649633|NCT04549259|183191909|OTHER|Single group change over time.|B|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.57|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.57
91598756|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
91598757|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
91598758|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
91598759|NCT01077973|183088754|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
91598760|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|3.89||||0.355|TWO_SIDED|95.0|-3.33|11.1||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.10|-3.33|0.355
91649634|NCT04549259|183191909|OTHER|Single group change over time.|B|-0.92|STANDARD_ERROR_OF_MEAN|1.12||0.42|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.42
91709407|NCT03951753|183311456|OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.166|<|0.001|TWO_SIDED|95.0|1.59|2.24|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||2.24|1.59|<0.001
91598761|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.623|TWO_SIDED|95.0|-6.62|4.2||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.20|-6.62|0.623
91598762|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.11||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.11|-0.90|0.094
91784670|NCT00669409|183449996|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-30.5|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-30.5|
91784671|NCT00669409|183449997|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
91598763|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|4.43||||0.565|TWO_SIDED|95.0|-10.43|19.29||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.29|-10.43|0.565
91598764|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|-2.09||||0.765|TWO_SIDED|95.0|-16.15|11.97||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.97|-16.15|0.765
91598765|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|6.47||||0.288|TWO_SIDED|95.0|-5.43|18.37||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.37|-5.43|0.288
91598766|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|-0.87||||0.928|TWO_SIDED|95.0|-20.0|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-20.00|0.928
91598767|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|-6.4||||0.495|TWO_SIDED|95.0|-25.14|12.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.33|-25.14|0.495
91598768|NCT01077973|183088757|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.477|TWO_SIDED|95.0|-9.66|20.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.59|-9.66|0.477
91598769|NCT02780648|183088864|OTHER|||||||0.824||||||This p-value represents the type III p-value for overall treatment phase variable significance. An a priori alpha level of 0.05 was used to determine statistical significance.|Mixed Models Analysis|||For Cohort B, pain scores were compared across treatment phase (before, during, and after) using ordinal logistic regression models with repeated measures.||||0.824
91598770|NCT02780648|183088865|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite global health status / quality of life score as the outcome.||||||0.27||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite global health status / quality of life scores across treatment phase.||||0.270
91598771|NCT02780648|183088866|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite physicial functioning composite score as the outcome.||||||0.179||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite physical functioning composite scores across treatment phase.||||0.179
91598772|NCT02780648|183088866|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite role functioning composite score as the outcome.||||||0.789||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite role functioning composite scores across treatment phase.||||0.789
91784672|NCT00669409|183449997|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
91784673|NCT00669409|183449997|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-12.6|19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.0|-12.6|
91784674|NCT00669409|183449997|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.0|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-25.0|
91784675|NCT00669409|183449997|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-25.4|16.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.1|-25.4|
91784676|NCT00669409|183449998|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-18.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-18.1|
91598773|NCT02780648|183088866|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite emotional functioning composite score as the outcome.||||||0.303||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite emotional functioning composite scores across treatment phase.||||0.303
91598774|NCT02780648|183088866|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite cognitive functioning composite score as the outcome.||||||0.989||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite cognitive functioning composite scores across treatment phase.||||0.989
91598775|NCT02780648|183088866|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite social functioning composite score as the outcome.||||||0.436||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite social functioning composite scores across treatment phase.||||0.436
91598776|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite fatigue symptom score as the outcome.||||||0.659||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite fatigue symptom scores across treatment phase.||||0.659
91598777|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite nausea and vomiting symptom score as the outcome.||||||0.295||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite nausea and vomiting symptom scores across treatment phase.||||0.295
91598778|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite pain symptom score as the outcome.||||||0.299||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite pain symptom scores across treatment phase.||||0.299
91598779|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite dyspnea symptom score as the outcome.||||||0.794||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite dyspnea symptom scores across treatment phase.||||0.794
91598780|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite insomnia symptom score as the outcome.||||||0.45||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite insomnia symptom scores across treatment phase.||||0.450
91598781|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite appetite loss symptom score as the outcome.||||||0.389||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite appetite loss symptom scores across treatment phase.||||0.389
91598782|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite constipation symptom score as the outcome.||||||0.011||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|The odds of having a higher constipation symptom composite score after treatment were less than during or before treatment.||The null hypothesis was that there was no difference in composite constipation symptom scores across treatment phase.||||0.011
91598783|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite diarrhea symptom score as the outcome.||||||0.101||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite diarrhea symptom scores across treatment phase.||||0.101
91598784|NCT02780648|183088867|OTHER|Ordinal logistic regression models with repeated measures to account for multiple patient surveys were fit with treatment phase (before treatment, during treatment, and after treatment) as the predictor and composite financial difficulty symptom score as the outcome.||||||0.306||||||The a priori threshold for statistical significance was 0.05. P-value represents the omnibus p-value for treatment phase in the repeated-measures ordinal logistic regression model.|Regression, Logistic|||The null hypothesis was that there was no difference in composite financial difficulty symptom scores across treatment phase.||||0.306
91598785|NCT01097304|183088873|OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
91598786|NCT01097304|183088874|OTHER||||||<|0.0001|||||||signed rank test|||||||<0.0001
91598787|NCT01097304|183088875|OTHER||||||<|0.01|||||||signed rank test|||||||<0.01
91598788|NCT01097304|183088876|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
91598789|NCT02685709|183088877|NON_INFERIORITY|An assessment of NI was made by comparing the lower bound of the two-sided 95% confidence interval (CI) for the difference in biochemical control (octreotide capsules - SRLs) to a NI margin of -20%.|95% CI Stratified Miettinen & Nurminen|-19.9|||||TWO_SIDED|95.0|-19.9|0.5|||Stratified Miettinen & Nurminen (M&N)|||||0.5|-19.9|
91598790|NCT02685709|183088878|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
91598791|NCT02685709|183088879|OTHER||||||||||||||Clopper-Pearson method|||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
91598792|NCT02685709|183088880|OTHER|||||||||||||Confidence interval was applied||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
91598793|NCT02685709|183088881|OTHER||||||||||||||Clopper-Pearson method|||Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.|Based on this analysis 63.0% of patients in the octreotide capsule group and 51.4% of patients in the SRL injection group entered the Study Extension phase.|||
91598794|NCT02685709|183088882|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The mean change in IGF-1 from RCT Baseline to the end of the RCT phase was calculated using the Last Observation Carried Forward (LOCF) approach.|||
91598795|NCT02685709|183088883|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|Estimates were obtained from an analysis of covariance (ANCOVA) for the mean integrated growth hormone (GH) change from baseline with explanatory factors of treatment group and baseline value.|||
91598796|NCT02685709|183088884|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing|The week 26 value was used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
91598797|NCT02685709|183088885|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing.|The week 26 value is used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
91598798|NCT02685709|183088886|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing.|This sensitivity analysis was using the Full analysis set (FAS), where any patient who discontinued treatment early was imputed as non-responder.|||
91598799|NCT02685709|183088887|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing|This sensitivity analysis was using the Full analysis set (FAS), where patient who were biochemically controlled at the RCT Baseline (week 26), and who discontinued treatment early was imputed as non-responder.|||
91598800|NCT02685709|183088888|OTHER||Proportion of patients|64.4|||||TWO_SIDED|95.0|56.0|72.1|||||Confidence Interval estimated using the Clopper-Pearson (Exact) method.||The proportion of patients biochemically controlled at the end of the Run-in phase was defined as IGF-1 \< 1.3 times ULN \[based on the average of week 24 and week 26\])|72.1|56|
91598801|NCT02685709|183088889|OTHER||Proportion of patients|66.4|||||TWO_SIDED|95.0|58.5|74.1||||||||74.1|58.5|
91598802|NCT02685709|183088890|OTHER||Proportion of patients|48.9|||||TWO_SIDED|95.0|38.7|59.1||||||||59.1|38.7|
91598803|NCT02685709|183088894|OTHER||||||||||||||||||The LSM change from baseline estimates are from a mixed model for repeated measures.|||
91598804|NCT01110200|183088904|SUPERIORITY_OR_OTHER||Treatment comparison ratio|0.917||||0.71|TWO_SIDED|95.0|0.581|1.447|||Negative bionomial regression model||Annualized rate estimates, the treatment comparison ratio, the confidence interval, and the p-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity, and time on treatment.|||1.447|0.581|0.710
91598805|NCT04817111|183088912|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91598806|NCT04817111|183088914|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
91598807|NCT04817111|183088915|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91613656|NCT04400318|183121533|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-53.45|STANDARD_ERROR_OF_MEAN|39.562||0.18|TWO_SIDED|95.0|-132.09|25.19|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of trimmed distal \[s\]iRaw at TLC, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction, and baseline-by-visit interaction as covariates.||25.19|-132.09|0.180
91649635|NCT02008721|183191975|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.51
91649636|NCT02008721|183191976|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.82
91649637|NCT02008721|183191977|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.99
91649638|NCT02008721|183191978|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.43
91649639|NCT01967888|183191993|SUPERIORITY||t-test|-1.2||||0.542|TWO_SIDED|95.0|-14.3|0.0|||Cochran-Mantel-Haenszel|||||000|-14.3|0.542
91649640|NCT01967888|183191994|SUPERIORITY||least square mean difference|-0.1601778||||0.092|TWO_SIDED|95.0|-0.317803|-0.0025525|||t-test, 2 sided|||||-0.0025525|-0.3178030|0.092
91598808|NCT05103332|183088950|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|95.0|-16.5|-7.6||MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \& BA estimated glomerular filtration rate (eGFR). Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-7.6|-16.5|<0.0001
91598809|NCT05103332|183088951|SUPERIORITY||Difference in LS Mean|-9.7|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|-12.9|-6.6||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.6|-12.9|<0.0001
91598810|NCT05103332|183088952|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.89|=|0.0183|TWO_SIDED|95.0|-8.2|-0.8||MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \& BA eGFR. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while subjects were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-0.8|-8.2|=0.0183
91613657|NCT02078713|183121543|SUPERIORITY||Odds Ratio (OR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.22|0.65|0.46
91649641|NCT01967888|183191995|SUPERIORITY||least square mean difference|-0.1178242||||0.161|TWO_SIDED|95.0|-0.287431|0.0517825|||t-test, 2 sided|||||0.0517825|-0.2874310|0.161
91649642|NCT01967888|183191996|SUPERIORITY||least square mean difference|0.0136||||0.846|TWO_SIDED|95.0|-0.0508|0.0781|||t-test, 2 sided|||||0.0781|-0.0508|0.846
91649643|NCT01967888|183191997|SUPERIORITY||least square mean difference|-0.025||||0.817|TWO_SIDED|95.0|-0.0939|0.0689|||t-test, 2 sided|||||0.0689|-0.0939|0.817
91649644|NCT01967888|183191998|SUPERIORITY||least square mean difference|-9.4641||||0.57|TWO_SIDED|95.0|-42.49|23.5618|||Mixed Models Analysis|||||23.5618|-42.4900|0.570
91649645|NCT01967888|183191999|SUPERIORITY||least square mean difference|-22.9454|||=|0.074|TWO_SIDED|95.0|-48.1826|2.2918|||Mixed Models Analysis|||||2.2918|-48.1826|=0.074
91649646|NCT01967888|183192000|SUPERIORITY||least square mean difference|-0.2074|||=|0.358|TWO_SIDED|95.0|-0.6538|0.2389|||Mixed Models Analysis|||||0.2389|-0.6538|=0.358
91649647|NCT01967888|183192001|SUPERIORITY||least square mean difference|-0.277|||=|0.288|TWO_SIDED|95.0|-0.7936|0.2396|||Mixed Models Analysis|||||0.2396|-0.7936|=0.288
91598811|NCT05103332|183088953|SUPERIORITY||Difference in LS Mean|-18.5|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-22.8|-14.2||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-14.2|-22.8|<0.0001
91598812|NCT05103332|183088954|SUPERIORITY||Difference in LS Mean|-11.0|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-14.7|-7.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-7.3|-14.7|<0.0001
91598813|NCT05103332|183088955|SUPERIORITY||Difference in LS Mean|-13.6|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|-16.9|-10.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-10.3|-16.9|<0.0001
91598814|NCT05103332|183088956|SUPERIORITY||Odds Ratio (OR)|12.39|||<|0.0001|TWO_SIDED|95.0|4.61|33.29||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||33.29|4.61|<0.0001
91598815|NCT05103332|183088967|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-13.4|-6.9||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.9|-13.4|<0.0001
91598816|NCT05103332|183088968|SUPERIORITY||Difference in LS Mean|-7.9|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-10.6|-5.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-5.3|-10.6|<0.0001
91613658|NCT02078713|183121543|SUPERIORITY||Odds Ratio (OR)|0.79||||0.16|TWO_SIDED|95.0|0.57|1.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.10|0.57|0.16
91613659|NCT02078713|183121544|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.05|1.03|0.03
91784677|NCT00669409|183449998|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-33.6|-2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.1|-33.6|
91784678|NCT00669409|183449998|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-17.2|14.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.4|-17.2|
91784679|NCT00669409|183449998|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.7|4.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.4|-26.7|
91598817|NCT05103332|183088969|SUPERIORITY||Difference in LS Mean|-8.6|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-10.9|-6.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-6.3|-10.9|<0.0001
91598818|NCT05103332|183088970|SUPERIORITY||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.43|10.61||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||10.61|2.43|<0.0001
91598819|NCT05103332|183088981|SUPERIORITY||Difference in LS Mean|-6.7|STANDARD_ERROR_OF_MEAN|1.76|=|0.0002|TWO_SIDED|95.0|-10.2|-3.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-3.3|-10.2|=0.0002
91598820|NCT05103332|183088982|SUPERIORITY||Difference in LS Mean|-1.8|STANDARD_ERROR_OF_MEAN|1.42|=|0.2103|TWO_SIDED|95.0|-4.6|1.0||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||1.0|-4.6|=0.2103
91598821|NCT05103332|183088983|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|-6.8|-2.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-2.3|-6.8|<0.0001
91598822|NCT05103332|183088984|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.123|TWO_SIDED|95.0|0.87|3.23||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||3.23|0.87|=0.1230
91598823|NCT02043548|183089016|SUPERIORITY|||||||0.86|||||||GEE|||||||0.86
91598824|NCT02043548|183089017|SUPERIORITY|||||||0.77|||||||Log Rank|||||||0.77
91598825|NCT02043548|183089018|SUPERIORITY|||||||0.4|||||||binomial test|||||||0.40
91598826|NCT02043548|183089019|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
91598827|NCT02043548|183089020|SUPERIORITY|||||||0.78|||||||GEE|||||||0.78
91598828|NCT02043548|183089020|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
91598829|NCT00507559|183089023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.||||<0.001
91598830|NCT02600494|183089062|SUPERIORITY||Least Squares Mean Difference|0.9||||0.514|TWO_SIDED|95.0|-1.83|3.53||p-value is Hochberg-adjusted|Mixed Effects Model for Repeated Measure|||||3.53|-1.83|0.514
91598831|NCT02600494|183089062|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.895|TWO_SIDED|95.0|-3.73|1.79||p-value is Hochberg adjusted|Mixed Effects Model for Repeated Measure|||||1.79|-3.73|0.895
91598832|NCT02600494|183089063|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.993|TWO_SIDED|95.0|0.712|1.4|||Regression, Cox|||||1.400|0.712|0.993
91598833|NCT02600494|183089063|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.665|TWO_SIDED|95.0|0.657|1.307|||Regression, Cox|||||1.307|0.657|0.665
91598834|NCT03987854|183089126|SUPERIORITY||paired t-test|-7.67|STANDARD_DEVIATION|6.1|<|0.001|TWO_SIDED|||||-6.16|t-test, 2 sided|||||||<.001
91598835|NCT03987854|183089127|SUPERIORITY||paired t-test|-0.21|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|||||-3.29|t-test, 2 sided|||||||.001
91598836|NCT03987854|183089128|SUPERIORITY||paired t-test|1.92|STANDARD_DEVIATION|1.17|<|0.001|TWO_SIDED|||||7.52|t-test, 2 sided|||||||<.001
91598837|NCT03987854|183089129|SUPERIORITY||paired t-test|1.14|STANDARD_DEVIATION|1.04|<|0.001|TWO_SIDED|||||5.03|t-test, 2 sided|||||||<.001
91598838|NCT03987854|183089130|SUPERIORITY||paired t-test|2.52|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|||||6.81|t-test, 2 sided|||||||<.001
91598839|NCT03987854|183089131|SUPERIORITY||paired t-test|1.08|STANDARD_DEVIATION|1.43||0.003|TWO_SIDED|||||3.46|t-test, 2 sided|||||||.003
91598840|NCT03987854|183089132|SUPERIORITY||paired t-test|1.11|STANDARD_DEVIATION|1.56||0.004|TWO_SIDED|||||3.26|t-test, 2 sided|||||||.004
91598841|NCT03987854|183089133|SUPERIORITY||paired t-test|2.1|STANDARD_DEVIATION|2.76||0.002|TWO_SIDED|||||3.49|t-test, 2 sided|||||||.002
91598842|NCT02799069|183089146|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.0|||||ONE_SIDED|97.5|5.9||||||||||5.9|
91598843|NCT02799069|183089146|SUPERIORITY||Difference to BF-200 ALA|61.1||||0|TWO_SIDED|95.0|51.2|71.0|||Chi-squared|||"Superiority of BF-200 ALA compared to placebo:~A sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05."||71.0|51.2|0.0000
91598844|NCT02799069|183089147|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.2|||||ONE_SIDED|97.5|6.0||||||||||6.0|
91598845|NCT02799069|183089147|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|59.4||||0|TWO_SIDED|95.0|48.4|70.4|||Chi-squared|||||70.4|48.4|0.0000
91598846|NCT02799069|183089148|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|72.0||||0|TWO_SIDED|95.0|59.7|84.2|||Chi-squared|||||84.2|59.7|0.0000
91598847|NCT02799069|183089148|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|17.3|||||ONE_SIDED|97.5|6.6||||||||||6.6|
91598848|NCT02171611|183089186|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|175.14|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|141.904|216.149|||||Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.149|141.904|
91598849|NCT02171611|183089186|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|154.84|STANDARD_ERROR_OF_MEAN|46.6|||TWO_SIDED|90.0|127.425|188.161|||||Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||188.161|127.425|
91598850|NCT02171611|183089187|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|175.4|STANDARD_ERROR_OF_MEAN|51.1|||TWO_SIDED|90.0|141.924|216.772|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.772|141.924|
91598851|NCT02171611|183089187|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|158.12|STANDARD_ERROR_OF_MEAN|46.7|||TWO_SIDED|90.0|130.052|192.255|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||192.255|130.052|
91649648|NCT01967888|183192002|SUPERIORITY||least square mean difference|0.09716|||=|0.98|TWO_SIDED|95.0|-7.41834|7.61266|||Mixed Models Analysis|||||7.61266|-7.41834|=0.980
91784680|NCT00669409|183449998|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-46.5|-5.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.0|-46.5|
91784681|NCT00669409|183449999|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.6|15.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.0|-16.6|
91784682|NCT00669409|183449999|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-32.8|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.8|
91784683|NCT00669409|183449999|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.0|10.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-21.0|
91598852|NCT02171611|183089188|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|186.94|STANDARD_ERROR_OF_MEAN|57.7|||TWO_SIDED|90.0|147.659|236.665|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||236.665|147.659|
91598853|NCT02171611|183089188|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.59|STANDARD_ERROR_OF_MEAN|54.3|||TWO_SIDED|90.0|133.221|208.326|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.326|133.221|
91598854|NCT02171611|183089189|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|181.6|STANDARD_ERROR_OF_MEAN|53.9|||TWO_SIDED|90.0|145.428|226.776|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||226.776|145.428|
91598855|NCT02171611|183089189|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.83|STANDARD_ERROR_OF_MEAN|52.6|||TWO_SIDED|90.0|134.25|207.328|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||207.328|134.25|
91598856|NCT02171611|183089190|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.17|STANDARD_ERROR_OF_MEAN|56.1|||TWO_SIDED|90.0|144.727|229.297|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.297|144.727|
91598857|NCT02171611|183089190|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|160.74|STANDARD_ERROR_OF_MEAN|52.0|||TWO_SIDED|90.0|129.633|199.306|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||199.306|129.633|
91598858|NCT02171611|183089191|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.25|STANDARD_ERROR_OF_MEAN|55.7|||TWO_SIDED|90.0|144.993|229.075|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.075|144.993|
91598859|NCT02171611|183089191|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|164.01|STANDARD_ERROR_OF_MEAN|51.7|||TWO_SIDED|90.0|132.421|203.14|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||203.14|132.421|
91598860|NCT00137111|183089240|SUPERIORITY_OR_OTHER_LEGACY||Binomial proportion|79.27|||||TWO_SIDED|95.0|75.69|82.85|||Binomial proportion|||Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.||82.85|75.69|
91598861|NCT00137111|183089241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||||||p-value from t-test after stratified for lineage and ploidy|t-test, 2 sided|||t-test stratified for lineage and ploidy||||.0062
91598862|NCT00137111|183089242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||p-value from t-test after adjusted for lineage and ploidy|t-test, 2 sided|||t-test adjusting for lineage and ploidy||||.15
91598863|NCT00137111|183089243|SUPERIORITY_OR_OTHER_LEGACY|||||||9.5e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.00000095
91598864|NCT00137111|183089244|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.0000007
91598865|NCT00852995|183089251|SUPERIORITY_OR_OTHER|||||||0.00028|TWO_SIDED||||||t-test, 2 sided|||||||0.00028
91598866|NCT00852995|183089251|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||t-test, 2 sided|||||||0.0899
91784684|NCT00669409|183449999|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.3|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-28.3|
91784685|NCT00669409|183449999|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-49.6|-8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.2|-49.6|
91784686|NCT00669409|183450000|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.8|14.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-16.8|
91784687|NCT00669409|183450000|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-35.0|
91784688|NCT00669409|183450000|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.8|9.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.8|-21.8|
91784689|NCT00669409|183450000|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.0|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-28.0|
91598867|NCT00852995|183089251|SUPERIORITY_OR_OTHER|||||||0.1586|TWO_SIDED||||||t-test, 2 sided|||||||0.1586
91649649|NCT01967888|183192003|SUPERIORITY||least square mean difference|1.07617|||=|0.785|TWO_SIDED|95.0|-6.76562|8.91796|||Mixed Models Analysis|||||8.91796|-6.76562|=0.785
91784690|NCT00669409|183450000|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-50.6|-9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.1|-50.6|
91784691|NCT00669409|183450001|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-11.9|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-11.9|
91784692|NCT00669409|183450001|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.1|-3.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-35.1|
91784693|NCT00669409|183450001|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.3|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.3|
91598868|NCT00852995|183089251|SUPERIORITY_OR_OTHER|||||||0.0295|TWO_SIDED||||||t-test, 2 sided|||||||0.0295
91598869|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED|||||Treatment Week 01|ANCOVA|||||||.037
91598870|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||Treatment Week 02|ANCOVA|||||||.064
91598871|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Treatment Week 03|ANCOVA|||||||.161
91598872|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Treatment Week 04|ANCOVA|||||||.39
91598873|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||Treatment Week 05|ANCOVA|||||||.079
91598874|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||Treatment Week 06|ANCOVA|||||||.069
91598875|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Treatment Week 07|ANCOVA|||||||.026
91649650|NCT01967888|183192004|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
91784694|NCT00669409|183450001|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-27.8|3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.4|-27.8|
91784695|NCT00669409|183450001|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.0|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-45.8|-4.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.3|-45.8|
91784696|NCT00669409|183450002|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-9.1|22.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.5|-9.1|
91784697|NCT00669409|183450002|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-31.7|-0.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-31.7|
91784698|NCT00669409|183450002|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-18.5|
91784699|NCT00669409|183450002|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.9|5.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.3|-25.9|
91784700|NCT00669409|183450002|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-44.2|-2.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.7|-44.2|
91598876|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED|||||Treatment Week 08|ANCOVA|||||||.133
91598877|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|||||Treatment Week 09|ANCOVA|||||||.089
91649651|NCT01967888|183192005|SUPERIORITY|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||||||0.403
91598878|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|||||Treatment Week 10|ANCOVA|||||||.057
91598879|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||Treatment Week 11|ANCOVA|||||||.127
91598880|NCT00852995|183089253|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||Treatment Week 12|ANCOVA|||||||0.395
91598881|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.0133
91598882|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.3839|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.3839
91649652|NCT01967888|183192006|SUPERIORITY||Treatment effect|2.1||||0.842|TWO_SIDED|95.0|-18.2|22.33|||Chi-squared|||||22.33|-18.20|0.842
91649653|NCT01967888|183192007|SUPERIORITY||Hazard Ratio (HR)|3.21||||0.339|TWO_SIDED|95.0|0.29|34.97|||Anderson-Gill model|||||34.97|0.29|0.339
91649654|NCT01967888|183192008|SUPERIORITY||Treatment effect|5.0||||0.64|TWO_SIDED|95.0|-15.91|25.93|||Chi-squared|||||25.93|-15.91|0.640
91784701|NCT00669409|183450003|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.6|27.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.0|-4.6|
91598883|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.5721|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.5721
91598884|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.232
91598885|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0787|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.0787
91598886|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.7919|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.7919
91598887|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.6881|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.6881
91598888|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.9832|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.9832
91598889|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0466|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.0466
91598890|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.8435|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8435
91598891|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.8743|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8743
91598892|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.2884|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.2884
91598893|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0387|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.0387
91598894|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.8461|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.8461
91598895|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.9574
91598896|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.2994|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.2994
91649655|NCT01967888|183192014|SUPERIORITY|||||||0.448|||||||Wilcoxon rank-sum test|||||||0.448
91649656|NCT01967888|183192015|SUPERIORITY|||||||0.91|||||||Wilcoxon rank-sum test|||||||0.910
91649657|NCT01967888|183192016|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.000
91784702|NCT00669409|183450003|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.5|-30.0|
91784703|NCT00669409|183450003|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.3|17.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.3|-14.3|
91784704|NCT00669409|183450003|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.9|9.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.3|-21.9|
91784705|NCT00669409|183450003|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-40.5|1.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.0|-40.5|
91784706|NCT00669409|183450004|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.0|26.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.6|-5.0|
91784707|NCT00669409|183450004|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.0|
91784708|NCT00669409|183450004|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.6|17.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.0|-14.6|
91598897|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.1024|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.1024
91598898|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.8759
91598899|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.9008|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.9008
91598900|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.4618|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4618
91598901|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.2439|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.2439
91598902|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.749
91649658|NCT01967888|183192021|SUPERIORITY||least square mean difference|31.3491|||=|0.5018|TWO_SIDED|95.0|-60.998|123.7|||Mixed Models Analysis|||||123.70|-60.9980|=0.5018
91649659|NCT01967888|183192022|SUPERIORITY||Least square mean difference|23.5454|||=|0.4537|TWO_SIDED|95.0|-38.6619|85.7528|||Mixed Models Analysis|||||85.7528|-38.6619|=0.4537
91649660|NCT03175120|183192033|SUPERIORITY||Treatment contrast|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.75|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.||-0.75|-1.09|<.0001
91649661|NCT01859325|183192122|SUPERIORITY||Median Difference (Final Values)|-0.36||||0.406|TWO_SIDED|95.0|-1.41|0.67|||Wilcoxon (Mann-Whitney)|||Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.||0.67|-1.41|0.406
91709408|NCT03951753|183311456|OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.192|<|0.001|TWO_SIDED|95.0|0.46|1.21|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.21|0.46|<0.001
91784709|NCT00669409|183450004|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.0|10.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.2|-21.0|
91784710|NCT00669409|183450004|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-35.3|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-35.3|
91784711|NCT00669409|183450005|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.5|26.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.1|-5.5|
91784712|NCT00669409|183450005|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-27.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-27.0|
91784713|NCT00669409|183450005|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-13.3|18.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.3|-13.3|
91598903|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.3749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.3749
91598904|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.015
91598905|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0078
91598906|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.07
91598907|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.208
91598908|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0413|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0413
91598909|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0054
91598910|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.2031|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.2031
91709409|NCT03951753|183311457|OTHER||Least Squares Mean Difference|-38.1|||<|0.001|TWO_SIDED|95.0|-45.4|-30.7|||ANCOVA|||||-30.7|-45.4|<0.001
91784714|NCT00669409|183450005|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-19.2|
91784715|NCT00669409|183450005|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-34.4|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-34.4|
91784716|NCT00669409|183450006|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.8|26.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.8|-4.8|
91784717|NCT00669409|183450006|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-8.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-23.9|7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.6|-23.9|
91598911|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0894
91598912|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0288
91598913|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.6964|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.6964
91598914|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.59
91598915|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.7146
91598916|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.5008|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.5008
91598917|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.1235|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1235
91598918|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.5488|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.5488
91598919|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.4343|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.4343
91598920|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.1114|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1114
91598921|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.2119|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2119
91598922|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.0194|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.0194
91598923|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.506|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.506
91598924|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.2317|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2317
91598925|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.1144
91598926|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.6786|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.6786
91598927|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.7735|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.7735
91598928|NCT00852995|183089254|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.758
91598929|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||0.017
91598930|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||.041
91598931|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 05|Cochran-Mantel-Haenszel|||||||.017
91598932|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Week 06|Cochran-Mantel-Haenszel|||||||.011
91598933|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Week 07|Cochran-Mantel-Haenszel|||||||.014
91598934|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||Week 08|Cochran-Mantel-Haenszel|||||||.029
91598935|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Week 09|Cochran-Mantel-Haenszel|||||||.021
91598936|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.041
91598937|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.044
91598938|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.013
91598939|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.024
91709410|NCT03951753|183311457|OTHER||Least Squares Mean Difference|-47.1|||<|0.001|TWO_SIDED|95.0|-54.6|-39.5|||ANCOVA|||||-39.5|-54.6|<0.001
91598940|NCT00852995|183089255|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Week 12|Cochran-Mantel-Haenszel|||||||.027
91598941|NCT00852995|183089257|SUPERIORITY_OR_OTHER|||||||0.0211|TWO_SIDED|||||P-value for Kaplan-Meier Days to Closure|ANCOVA|||||||0.0211
91598942|NCT00852995|183089257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.83||||0.0212|TWO_SIDED|95.0|1.09|3.04|||Regression, Cox|||||3.04|1.09|.0212
91598943|NCT00852995|183089257|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||ANCOVA|||||||0.59
91598944|NCT00852995|183089257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.53|TWO_SIDED|95.0|0.69|2.05||This is the P-value for the Cox Hazard Ratio|Regression, Cox|||||2.05|.69|0.53
91598945|NCT00852995|183089257|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|Kaplan-Meier Days to Closure||||||0.26
91598946|NCT00852995|183089257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.19|TWO_SIDED|95.0|0.84|2.44||This is the P-value for the Cox Proportional Hazard Ratio|Regression, Cox|||||2.44|0.84|0.19
91598947|NCT00852995|183089257|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||P-value for Kaplan Meier Days to Closure|ANCOVA|||||||0.10
91598948|NCT00852995|183089257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.06|TWO_SIDED|95.0|0.97|2.77||P-value for Cox Proportional Hazard Ratio|Regression, Cox|||||2.77|0.97|0.06
91598949|NCT02508194|183089261|SUPERIORITY||Vaccine efficacy|-7.1|||||TWO_SIDED|90.0|-106.9|44.3|||||The CI was estimated by an exact conditional method.|2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = (\[1 - relative risk (RR)\] \*100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (\>) 0% would demonstrate the efficacy of MEDI7510.||44.3|-106.9|
91598950|NCT00511355|183089280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0849||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0849
91598951|NCT00511355|183089282|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598952|NCT00511355|183089283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4191||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.4191
91598953|NCT00511355|183089284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0010
91598954|NCT00511355|183089288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3779||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3779
91598955|NCT00511355|183089289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5027||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5027
91598956|NCT00511355|183089290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0041
91598957|NCT00511355|183089291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
91598958|NCT00511355|183089292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0004
91709411|NCT03951753|183311457|OTHER||Least Squares Mean Difference|-9.0||||0.006|TWO_SIDED|95.0|-15.4|-2.6|||ANCOVA|||||-2.6|-15.4|0.006
91784718|NCT00669409|183450006|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|1.8|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-14.0|
91784719|NCT00669409|183450006|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
91784720|NCT00669409|183450006|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-12.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-33.5|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-33.5|
91784721|NCT00669409|183450007|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.4|27.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.2|-4.4|
91784722|NCT00669409|183450007|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-21.2|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.2|
91784723|NCT00669409|183450007|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.2|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-11.2|
91784724|NCT00669409|183450007|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-20.3|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-20.3|
91598959|NCT00511355|183089293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0019
91598960|NCT00511355|183089294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
91598961|NCT00511355|183089295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0187||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0187
91598962|NCT00511355|183089296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598963|NCT00511355|183089297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6886||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.6886
91598964|NCT00511355|183089298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598965|NCT00511355|183089299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91709412|NCT03951753|183311458|OTHER||Least Squares Mean Difference|-14696.1|||<|0.001|TWO_SIDED|95.0|-17045.0|-12347.3|||ANCOVA|||||-12347.3|-17045.0|<0.001
91784725|NCT00669409|183450007|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.1|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-24.9|16.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.6|-24.9|
91784726|NCT00669409|183450008|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.7|12.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.3|-20.7|
91784727|NCT00669409|183450008|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.6|-3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.0|-35.6|
91598966|NCT00511355|183089300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0083||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0083
91598967|NCT00511355|183089301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0455||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0455
91598968|NCT00511355|183089302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0063
91598969|NCT00511355|183089303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598970|NCT00511355|183089304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91709413|NCT03951753|183311458|OTHER||Least Squares Mean Difference|-17873.2|||<|0.001|TWO_SIDED|95.0|-20239.0|-15507.4|||ANCOVA|||||-15507.4|-20239.0|<0.001
91784728|NCT00669409|183450008|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.5|12.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.1|-20.5|
91784729|NCT00669409|183450008|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-15.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.9|0.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.3|-31.9|
91784730|NCT00669409|183450008|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-35.1|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-56.4|-13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.8|-56.4|
91598971|NCT00511355|183089305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0078
91598972|NCT00511355|183089306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0016
91598973|NCT00511355|183089307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0003
91598974|NCT00511355|183089308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0009
91598975|NCT00511355|183089309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0024
91598976|NCT00511355|183089310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3653||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3653
91649662|NCT00986154|183192143|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed to accumulate approximately 220 Overall primary efficacy events in the mITT (modified Intent to Treat) Analysis Set. Assuming equal efficacy (Hazard Ratio = 1.00), a total of 220 events gave a power of 85% to demonstrate that (LMW) heparin/edoxaban was non-inferior to the comparator, considering a relative non-inferiority margin of 1.5 (two sided α=0.05).|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.703|1.128|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|(LMW) heparin/edoxaban will be non-inferior to (LMW) heparin/warfarin in preventing recurrence of acute, symptomatic VTE following initial index event. (LMW) Heparin/edoxaban was considered non-inferior to the standard therapy (\[LMW\] heparin/warfarin) if the upper limit of the two-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] heparin/edoxaban to standard therapy) was less than 1.5. Events included in Overall study period if occurred on or after randomization date up to Day 365.||1.128|.703|<0.0001
91709414|NCT03951753|183311458|OTHER||Least Squares Mean Difference|-3177.1||||0.002|TWO_SIDED|95.0|-5194.3|-1159.8|||ANCOVA|||||-1159.8|-5194.3|0.002
91784731|NCT00669409|183450009|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.2|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.2|
91784732|NCT00669409|183450009|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-33.0|-0.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-33.0|
91784733|NCT00669409|183450009|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-13.5|19.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.1|-13.5|
91598977|NCT00511355|183089311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598978|NCT00511355|183089312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598979|NCT00511355|183089313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5668||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5668
91598980|NCT00511355|183089314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.1770
91598981|NCT00511355|183089315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
91598982|NCT00217087|183089343|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED||||||Fisher Exact|||||||0.0098
91598983|NCT00217087|183089344|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Chi-squared|||||||0.34
91598984|NCT00217087|183089345|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus.||||||0.2
91598985|NCT00802685|183089346|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|STANDARD_DEVIATION|8.0||0.858|TWO_SIDED|95.0|4.0|36.0|||Wilcoxon (Mann-Whitney)|||Null hypothesis: Oxygen duration (days) during the first 28 days will be equal between treatment arms.||36|4|0.858
91598986|NCT00802685|183089347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.8|TWO_SIDED|95.0|0.393|2.309|||Cochran-Mantel-Haenszel|||null hypothesis: The proportion of subjects on O2 at 36 wk PMA will be equal between treatment arms.||2.309|0.393|0.8
91598987|NCT03208231|183089351|SUPERIORITY|||||||0.79|||||||Fisher Exact|||||||0.79
91598988|NCT03208231|183089352|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91598989|NCT01328951|183089394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8183|TWO_SIDED|95.0|0.85|1.22|||Log Rank||The HR and 95% confidence interval (CI) were estimated by Cox regression.|Unstratified Analysis.||1.22|0.85|0.8183
91598990|NCT01328951|183089394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5256|TWO_SIDED|95.0|0.87|1.32|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.32|0.87|0.5256
91598991|NCT01328951|183089395|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-0.4||||0.9207|TWO_SIDED|95.0|-8.25|7.45|||Chi-squared|||||7.45|-8.25|0.9207
91598992|NCT01328951|183089397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4759|TWO_SIDED|95.0|0.8|1.11|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Unstratified Analysis.||1.11|0.80|0.4759
91598993|NCT01328951|183089397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1635|TWO_SIDED|95.0|0.72|1.06|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.06|0.72|0.1635
91598994|NCT01328951|183089398|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-2.89||||0.4069|TWO_SIDED|95.0|-9.7|3.93|||Chi-squared|||||3.93|-9.70|0.4069
91598995|NCT01328951|183089399|SUPERIORITY_OR_OTHER||Difference in Response Rate|2.78||||0.1097|TWO_SIDED|95.0|-0.78|6.35|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||6.35|-0.78|0.1097
91784734|NCT00669409|183450009|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-29.2|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.2|
91598996|NCT01328951|183089399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.87|3.72|||||The 95% CI for OR was constructed using the Wald method.|||3.72|0.87|
91598997|NCT01328951|183089401|SUPERIORITY_OR_OTHER||Difference in Response Rate|1.99||||0.6062|TWO_SIDED|95.0|-5.74|9.72|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||9.72|-5.74|0.6062
91598998|NCT01328951|183089401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.79|1.49|||||The 95% CI for OR was constructed using the Wald method.|||1.49|0.79|
91598999|NCT03485820|183089402|SUPERIORITY||Mean Difference (Net)|1.3||||0.76|TWO_SIDED|95.0|-7.1|9.6||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||9.6|-7.1|0.76
91599000|NCT03485820|183089403|SUPERIORITY||Mean Difference (Net)|-1.8||||0.6|TWO_SIDED|95.0|-8.6|5.0||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||5.0|-8.6|0.60
91599001|NCT03485820|183089404|SUPERIORITY||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.06|0.05||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.05|-0.06|0.83
91649663|NCT00986154|183192144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9933|TWO_SIDED|95.0|0.832|1.2|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose.|||1.200|.832|.9933
91599002|NCT03485820|183089405|SUPERIORITY||Mean Difference (Net)|0.39||||0.046|TWO_SIDED|95.0|0.01|0.77||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression , number of days in inpatient rehabilitation, and baseline calendar time.||0.77|0.01|0.046
91522535|NCT01181726|182920070|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.96|||||TWO_SIDED|90.0|93.66|102.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.46|93.66|
91522536|NCT01181726|182920071|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.01|||||TWO_SIDED|90.0|94.17|104.11|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.11|94.17|
91522537|NCT01181726|182920072|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.13|||||TWO_SIDED|90.0|94.39|104.1|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.10|94.39|
91522538|NCT01181726|182920073|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.72|||||TWO_SIDED|90.0|94.03|101.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.56|94.03|
91522539|NCT01181726|182920074|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.99|||||TWO_SIDED|90.0|94.11|102.02|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.02|94.11|
91649664|NCT00986154|183192145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.004|TWO_SIDED|95.0|0.705|0.936|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|"Safety Analysis set includes all randomized subjects who received at least one dose of study drug.~Null hypothesis (LMW) heparin/edoxaban will be comparable to (LMW) heparin/warfarin in preventing recurrence of major or clinically relevant non-major bleeding."||.936|.705|.0040
91784735|NCT00669409|183450009|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-32.8|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-32.8|
91784736|NCT00669409|183450010|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-22.9|10.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.1|-22.9|
91784737|NCT00669409|183450010|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.7|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.7|
91784738|NCT00669409|183450010|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-15.0|
91784739|NCT00669409|183450010|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-27.1|5.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-27.1|
91784740|NCT00669409|183450010|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-26.0|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-26.0|
91784741|NCT00669409|183450011|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.1|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-21.1|
91784742|NCT00669409|183450011|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.9|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-35.9|
91784743|NCT00669409|183450011|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-20.4|
91784744|NCT00669409|183450011|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.0|2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.3|-30.0|
91784745|NCT00669409|183450011|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.8|-6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.2|-48.8|
91784746|NCT00669409|183450012|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-19.6|13.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.4|-19.6|
91599003|NCT03485820|183089406|SUPERIORITY||Mean Difference (Net)|0.52||||0.02|TWO_SIDED|95.0|0.08|0.96||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.96|0.08|0.02
91599004|NCT03485820|183089407|SUPERIORITY||Mean Difference (Net)|-10.6||||0.07|TWO_SIDED|95.0|-21.9|0.8||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.8|-21.9|0.07
91599005|NCT04289116|183089408|SUPERIORITY||Chi Square|1.36||||0.2|TWO_SIDED||||||Negative Binomial Regression|||Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.||||0.20
91599006|NCT04289116|183089408|SUPERIORITY||Chi Square|0.03||||0.58|TWO_SIDED||||||Negative Binomial Regression|||Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.||||0.58
91599007|NCT04289116|183089409|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.08|TWO_SIDED||||||t-test, 2 sided|||Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.||||0.08
91599008|NCT04289116|183089409|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.02|TWO_SIDED||||||t-test, 2 sided|||Analysis only includes participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.||||0.02
91599009|NCT04209855|183089421|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.513|0.785|||Log Rank|||||0.785|0.513|<0.0001
91599010|NCT00271817|183089429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-41.4|-35.4||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-35.4|-41.4|<0.001
91599011|NCT00271817|183089430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-36.5|-30.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-30.6|-36.5|<0.001
91599012|NCT00271817|183089431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|18.8|25.3||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.3|18.8|<0.001
91599013|NCT00271817|183089432|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-18.7|||<|0.001||95.0|-22.6|-14.7||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender|"Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-14.7|-22.6|<0.001
91599014|NCT00271817|183089433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|18.0|25.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.0|18.0|<0.001
91599015|NCT00271817|183089434|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|||<|0.001||95.0|-21.8|-13.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender.|"Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-13.6|-21.8|<0.001
91599016|NCT00271817|183089435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-10.4|-4.2||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-4.2|-10.4|<0.001
91709415|NCT03951753|183311459|OTHER||Least Squares Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.18|-1.67|||Mixed Models Analysis|||||-1.67|-2.18|<0.001
91709416|NCT03951753|183311459|OTHER||Least Squares Mean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-2.58|-2.08|||Mixed Models Analysis|||||-2.08|-2.58|<0.001
91709417|NCT03951753|183311459|OTHER||Least Squares Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.19|||Mixed Models Analysis|||||-0.19|-0.63|<0.001
91599017|NCT00271817|183089436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.6||0.004||95.0|-8.0|-1.5||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-1.5|-8.0|0.004
91599018|NCT00271817|183089437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.7|-2.1||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-2.1|-7.7|<0.001
91599019|NCT00271817|183089438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.4|-5.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-5.0|-10.4|<0.001
91599020|NCT01411085|183089471|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.317|TWO_SIDED||||||t-test, 2 sided|||The assessment was between baseline and values for last 8 weeks.||||0.317
91599021|NCT01564862|183089472|SUPERIORITY_OR_OTHER||LS mean difference|1.75|STANDARD_ERROR_OF_MEAN|0.744||0.019|TWO_SIDED|95.0|0.28|3.21||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||3.21|0.28|0.019
91599022|NCT01564862|183089472|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.733||0.099|TWO_SIDED|95.0|-0.23|2.65||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||2.65|-0.23|0.099
91599023|NCT01564862|183089472|SUPERIORITY_OR_OTHER||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.725||0.46|TWO_SIDED|95.0|-0.89|1.96||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||1.96|-0.89|0.460
91599024|NCT01564862|183089473|SUPERIORITY_OR_OTHER||LS Mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.1|-1.0||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.0|-4.1|0.001
91599025|NCT01564862|183089473|SUPERIORITY_OR_OTHER||LS mean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.77|<|0.001|TWO_SIDED|95.0|-4.5|-1.5||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.5|-4.5|<0.001
91599026|NCT01564862|183089474|SUPERIORITY_OR_OTHER||LS Mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1211||0.017|TWO_SIDED|95.0|-0.528|-0.052||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.052|-0.528|0.017
91599027|NCT01564862|183089474|SUPERIORITY_OR_OTHER||LS mean difference|-0.404|STANDARD_ERROR_OF_MEAN|0.1194|<|0.001|TWO_SIDED|95.0|-0.638|-0.169||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.169|-0.638|<0.001
91599028|NCT03809611|183089487|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.1832|TWO_SIDED|90.0|-1.34|4.56||One-sided p-value for treatment difference|Mixed Models Analysis|||||4.56|-1.34|0.1832
91599029|NCT03809611|183089488|SUPERIORITY||Odds Ratio (OR)|1.9||||0.283|TWO_SIDED|90.0|0.72|4.78|||Cochran-Mantel-Haenszel|||||4.78|0.72|0.2830
91599030|NCT00313209|183089490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|27.0|71.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||71|27|<0.0001
91599031|NCT00313209|183089491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|38.0|82.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||82|38|<0.0001
91599032|NCT00313209|183089492|SUPERIORITY_OR_OTHER||Rate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.12||0.1408|TWO_SIDED|95.0|0.58|1.08||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.08|0.58|0.1408
91599033|NCT00313209|183089493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4654|TWO_SIDED|95.0|-0.2|0.4||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.4|-0.2|0.4654
91599034|NCT00313209|183089494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.9||0.5457|TWO_SIDED|95.0|-1.2|2.2||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||2.2|-1.2|0.5457
91599035|NCT02193074|183089495|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|50.68|||<|0.0001|TWO_SIDED|95.0|31.81|66.48|||Fisher Exact||exact unconditional confidence interval|||66.48|31.81|< 0.0001
91599036|NCT02193074|183089496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||Log Rank|Based on log-rank test stratified by disease duration.||||||0.0046
91599037|NCT02193074|183089496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0164|TWO_SIDED|95.0|0.3156|0.8902|||Cox proportional hazards model|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.8902|0.3156|0.0164
91599038|NCT02193074|183089497|SUPERIORITY_OR_OTHER_LEGACY||DIfference in percentages|68.53|||<|0.0001|TWO_SIDED|95.0|51.27|81.99|||Fisher Exact|||||81.99|51.27|< 0.0001
91599039|NCT02193074|183089498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||Log Rank|Based on log-rank test stratified by disease duration (primary analysis).||||||0.0041
91599040|NCT02193074|183089498|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.372||||0.0082|TWO_SIDED|95.0|0.1787|0.7745|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening (sensitivity analysis).||||0.7745|0.1787|0.0082
91599041|NCT02193074|183089500|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|30.21||||0.0004|TWO_SIDED|95.0|10.35|48.09|||Fisher Exact|||||48.09|10.35|0.0004
91599042|NCT02193074|183089501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Log Rank|||||||0.0003
91599043|NCT02193074|183089501|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.24||||0.0014|TWO_SIDED|95.0|0.1002|0.5753|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.5753|0.1002|0.0014
91599044|NCT02193074|183089502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3953|||||||Log Rank|||||||0.3953
91649665|NCT00267293|183192150|NON_INFERIORITY_OR_EQUIVALENCE|Power for 80%|||||<|0.001||||||comparision of mean temperatures from repeated exposure. At hour 6 temperature|Mixed Models Analysis|||Power for 80%||||<0.001
91784747|NCT00669409|183450012|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.8|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.8|
91784748|NCT00669409|183450012|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.4|7.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.4|
91784749|NCT00669409|183450012|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.8|-0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.5|-32.8|
91784750|NCT00669409|183450012|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.9|-11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.4|-53.9|
91784751|NCT00669409|183450013|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.1|12.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.9|-20.1|
91599045|NCT02193074|183089502|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.6268|TWO_SIDED|95.0|0.427|1.6698|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||1.6698|0.4270|0.6268
91599046|NCT03124563|183089526|SUPERIORITY||||||=|0.006|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||=.006
91599047|NCT03124563|183089527|SUPERIORITY|||||||0.034|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||.034
91599048|NCT03124563|183089528|SUPERIORITY|||||||0.065|||||||Mixed Models Analysis|Controlling for age, gender, and education||||||.065
91599049|NCT03124563|183089529|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.308
91784752|NCT00669409|183450013|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.9|-5.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.2|-37.9|
91784753|NCT00669409|183450013|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.7|6.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.9|-25.7|
91784754|NCT00669409|183450013|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.5|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-31.5|
91784755|NCT00669409|183450013|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.7|-11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.2|-53.7|
91784756|NCT00669409|183450014|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-17.0|16.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.0|-17.0|
91784757|NCT00669409|183450014|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.6|-4.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-37.6|
91784758|NCT00669409|183450014|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.1|8.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.5|-24.1|
91784759|NCT00669409|183450014|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.2|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.2|
91784760|NCT00669409|183450014|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.1|-5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.5|-48.1|
91784761|NCT00669409|183450015|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-12.8|20.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.2|-12.8|
91784762|NCT00669409|183450015|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-34.8|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-34.8|
91784763|NCT00669409|183450015|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-21.7|11.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.0|-21.7|
91784764|NCT00669409|183450015|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.1|2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.1|-30.1|
91649666|NCT00267293|183192150|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Binary outcome \<38C and \>=38C|Chi-squared|||||||<.0001
91599050|NCT03124563|183089530|SUPERIORITY|||||||0.349|||||||ANOVA|||||||.349
91599051|NCT03124563|183089531|SUPERIORITY|||||||0.022|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.022
91599052|NCT03160560|183089608|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.010
91649667|NCT01684722|183192153|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.25
91649668|NCT01684722|183192153|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.27|TWO_SIDED|95.0|-0.7|2.6|||Mixed Models Analysis|||||2.6|-0.7|0.27
91649669|NCT01684722|183192154|SUPERIORITY||Ratio of change from baseline, active to|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Mixed Models Analysis|||||1.17|0.84|0.90
91649670|NCT01684722|183192154|SUPERIORITY||Ratio of change from baseline, active to|0.96||||0.64|TWO_SIDED|95.0|0.81|1.14|||Mixed Models Analysis|||||1.14|0.81|0.64
91649671|NCT00219557|183192160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.1026|TWO_SIDED|95.0|0.49|1.17||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.170|0.490|0.1026
91649672|NCT00219557|183192171|SUPERIORITY_OR_OTHER||Difference in response rate|4.3||||0.661|TWO_SIDED|95.0|-4.0|12.7|||Fisher Exact|||Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).||12.7|-4.0|0.661
91599053|NCT03160560|183089608|SUPERIORITY|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.932
91649673|NCT00219557|183192173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9648||||0.4466|TWO_SIDED|95.0|0.54|1.73||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.7300|0.5400|0.4466
91599054|NCT03160560|183089608|SUPERIORITY|||||||0.853|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.853
91599055|NCT03160560|183089608|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Baseline-2, Week 6, Week 7, Week 8||||.032
91599056|NCT03160560|183089608|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.001
91599057|NCT03160560|183089608|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.750
91599058|NCT03160560|183089608|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.810
91599059|NCT03160560|183089608|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.006
91599060|NCT02814565|183089618|SUPERIORITY|||||||0.6179|TWO_SIDED|95.0|||||Wilcoxon Rank Sum test|||The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6179
91599061|NCT02814565|183089619|SUPERIORITY|||||||0.4338|||||||Wilcoxon Rank Sum Test|||Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4338
91649674|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.44|||||TWO_SIDED|95.0|-19.06|2.19||||||For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||2.19|-19.06|
91649675|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.02|||||TWO_SIDED|95.0|-15.4|3.36||||||For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||3.36|-15.4|
91649676|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.32|||||TWO_SIDED|95.0|-23.77|5.12||||||For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.12|-23.77|
91649677|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.73|||||TWO_SIDED|95.0|-15.25|5.79||||||For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.79|-15.25|
91649678|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||||TWO_SIDED|95.0|-15.83|5.61||||||For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.61|-15.83|
91649679|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-18.72|12.06||||||For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.06|-18.72|
91599062|NCT02814565|183089619|SUPERIORITY|||||||0.1657|||||||Wilcoxon Rank Sum Test|||Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1657
91599063|NCT02814565|183089620|SUPERIORITY|||||||0.0393|||||||Wilcoxon Sum Rank Test|||The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0393
91599064|NCT02814565|183089621|SUPERIORITY|||||||0.033|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0330
91599065|NCT02814565|183089621|SUPERIORITY|||||||0.0262|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0262
91599066|NCT02814565|183089622|SUPERIORITY|||||||0.5756|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5756
91649680|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.41|||||TWO_SIDED|95.0|-1.62|22.44||||||For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.44|-1.62|
91599067|NCT02814565|183089622|SUPERIORITY|||||||0.4395|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4395
91599068|NCT02814565|183089622|SUPERIORITY|||||||0.0905|||||||Wilcoxon Sum Rank Test|||Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0905
91599069|NCT02814565|183089623|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 3. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
91599070|NCT02814565|183089623|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 7. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
91599071|NCT02814565|183089623|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||"Day 14. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||0.2757
91599072|NCT02814565|183089624|SUPERIORITY|||||||0.302|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.3020
91599073|NCT02814565|183089624|SUPERIORITY|||||||0.2367|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2367
91599074|NCT02814565|183089624|SUPERIORITY|||||||0.025|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0250
91599075|NCT02814565|183089625|SUPERIORITY|||||||0.4428|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4428
91599076|NCT02814565|183089625|SUPERIORITY|||||||0.1163|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1163
91599077|NCT02814565|183089625|SUPERIORITY|||||||0.0489|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0489
91599078|NCT02814565|183089626|SUPERIORITY|||||||0.5275|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5275
91784765|NCT00669409|183450015|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-46.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-46.0|
91599079|NCT02814565|183089626|SUPERIORITY|||||||0.088|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0880
91599080|NCT02814565|183089626|SUPERIORITY|||||||0.2542|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2542
91599081|NCT02814565|183089627|SUPERIORITY|||||||0.692|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6920
91599082|NCT02814565|183089627|SUPERIORITY|||||||0.0749|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0749
91599083|NCT02814565|183089627|SUPERIORITY|||||||0.2371|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2371
91599084|NCT05587296|183089629|SUPERIORITY||Diffrence in Least Squares (LS) means|-3.48|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|ONE_SIDED|||||One-sided. A multiplicity adjustment strategy was defined using the hierarchical testing strategy, controlling the overall type I error rate at a one-sided alpha level of 0.025 for confirmatory statistical superiority testing.|Mixed model repeated measures (MMRM)|||||||<0.0001
91599085|NCT05587296|183089630|SUPERIORITY||Difference in Least Squares Means|-3.38|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|ONE_SIDED|||||One-sided. A multiplicity adjustment strategy was defined using the hierarchical testing strategy, controlling the overall type I error rate at a one-sided alpha level of 0.025 for confirmatory statistical superiority testing.|MMRM|||||||<0.0001
91784766|NCT00669409|183450016|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.5|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.5|
91784767|NCT00669409|183450016|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.0|0.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.6|-32.0|
91599086|NCT05587296|183089635|SUPERIORITY||Difference in Least Squares Means|-6.12|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|ONE_SIDED|||||One-sided. A multiplicity adjustment strategy was defined using the hierarchical testing strategy, controlling the overall type I error rate at a one-sided alpha level of 0.025 for confirmatory statistical superiority testing.|MMRM|||||||<0.0001
91599087|NCT05587296|183089636|SUPERIORITY||Difference in Last Squares Means|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|ONE_SIDED|||||One-sided. A multiplicity adjustment strategy was defined using the hierarchical testing strategy, controlling the overall type I error rate at a one-sided alpha level of 0.025 for confirmatory statistical superiority testing.|MMRM|||||||<0.0001
91649681|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.0|-16.55|7.96||||||For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||7.96|-16.55|
91649682|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.37|||||TWO_SIDED|95.0|-7.57|22.32||||||For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.32|-7.57|
91649683|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.51|||||TWO_SIDED|95.0|-1.28|26.3||||||For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||26.30|-1.28|
91649684|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||||TWO_SIDED|95.0|-5.7|25.49||||||For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||25.49|-5.70|
91649685|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|||||TWO_SIDED|95.0|-4.81|32.07||||||For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||32.07|-4.81|
91709418|NCT03951753|183311460|OTHER||Least Squares Mean Difference|279.14|STANDARD_ERROR_OF_MEAN|17.366|<|0.001|TWO_SIDED|95.0|245.1|313.18|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||313.18|245.10|<0.001
91599088|NCT04735653|183089649|SUPERIORITY||||||<|0.001||||||A Wilcoxon rank-sum test was used instead of ANOVA due to the non-normality of the adherence outcomes. We did not block on clinic due to differences in sample characteristics by site.|Wilcoxon (Mann-Whitney)|Medication adherence was compared between groups with a Wilcoxon rank-sum test.||||||<0.001
91649686|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||||TWO_SIDED|95.0|-11.62|20.96||||||For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-11.62|
91649687|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-15.1|12.54||||||For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.54|-15.1|
91649688|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|||||TWO_SIDED|95.0|-4.67|15.53||||||For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.53|-4.67|
91649689|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.83|||||TWO_SIDED|95.0|-32.34|0.67||||||For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.67|-32.34|
91709419|NCT03951753|183311460|OTHER||Least Squares Mean Difference|381.23|STANDARD_ERROR_OF_MEAN|21.399|<|0.001|TWO_SIDED|95.0|339.29|423.17|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||423.17|339.29|<0.001
91599089|NCT04735653|183089650|SUPERIORITY||||||<|0.001||||||A chi-squared test was used instead of Cochran-Mantel-Haenszel test due to site differences. Site differences will be incorporated into multivariable models to investigate moderating effects with treatment on the outcome in future analyses.|Chi-squared|||||||<0.001
91709420|NCT03951753|183311460|OTHER||Least Squares Mean Difference|102.09|STANDARD_ERROR_OF_MEAN|25.635|<|0.001|TWO_SIDED|95.0|51.84|152.33|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||152.33|51.84|<0.001
91599090|NCT04735653|183089651|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.5|-0.1|||||Adjustment for site was not performed. Site differences will be incorporated into multivariable models to investigate moderating effects with treatment on the outcome in future analyses.|||-0.1|-0.5|
91784768|NCT00669409|183450016|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.7|15.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.9|-16.7|
91599091|NCT04589988|183089659|SUPERIORITY|||||||0.068||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.068
91784769|NCT00669409|183450016|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-25.5|6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.7|-25.5|
91784770|NCT00669409|183450016|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-42.0|0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.5|-42.0|
91784771|NCT00669409|183450017|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-8.4|24.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.6|-8.4|
91784772|NCT00669409|183450017|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.6|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.6|
91599092|NCT04589988|183089660|SUPERIORITY|||||||0.063||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.063
91649690|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||||TWO_SIDED|95.0|-24.12|0.96||||||For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.96|-24.12|
91649691|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.65|||||TWO_SIDED|95.0|-35.47|-1.83||||||For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||-1.83|-35.47|
91784773|NCT00669409|183450017|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-17.1|15.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-17.1|
91784774|NCT00669409|183450017|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-24.4|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-24.4|
91784775|NCT00669409|183450017|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-38.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-38.0|
91784776|NCT00669409|183450018|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.8|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.7|25.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.3|-7.7|
91784777|NCT00669409|183450018|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-29.2|3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.5|-29.2|
91784778|NCT00669409|183450018|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.8|16.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.8|-15.8|
91784779|NCT00669409|183450018|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.6|8.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.6|-23.6|
91784780|NCT00669409|183450018|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.0|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-37.0|
91784781|NCT00669409|183450019|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.4|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.4|
91784782|NCT00669409|183450019|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-27.1|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-27.1|
91784783|NCT00669409|183450019|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.9|15.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.7|-16.9|
91784784|NCT00669409|183450019|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.9|8.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.4|-23.9|
91649692|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.92|||||TWO_SIDED|95.0|-29.16|1.32||||||For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||1.32|-29.16|
91649693|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-20.97|6.77||||||For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||6.77|-20.97|
91649694|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.62|||||TWO_SIDED|95.0|-28.28|9.04||||||For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||9.04|-28.28|
91649695|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.14|||||TWO_SIDED|95.0|-1.27|33.54||||||For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||33.54|-1.27|
91522540|NCT01264380|182920075|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|4.64|||||TWO_SIDED|90.0|2.83|7.6||||||The point estimate and 90 percent (%) confidence interval (CI) of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||7.60|2.83|
91522541|NCT01264380|182920076|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|5.05|||||TWO_SIDED|90.0|2.99|8.55||||||The point estimate and 90% CI of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||8.55|2.99|
91522542|NCT01264380|182920077|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|2.45|||||TWO_SIDED|90.0|1.81|3.32||||||The point estimate and 90% CI of vemurafenib plasma Cmax geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||3.32|1.81|
91522543|NCT04998604|182920087|SUPERIORITY|At each post-baseline visit, each of the imputed complete data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.|Least squares (LS) mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.182|<|0.001|TWO_SIDED|95.0|-1.96|-1.25||The threshold for statistical significance was 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control the type-I error and handle multiple secondary endpoint analysis. Testing was performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at 2-sided 0.05.||-1.25|-1.96|<0.001
91522544|NCT04998604|182920088|SUPERIORITY|At each post-baseline visit, each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.|LS mean difference|8.0|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|6.3|9.7||The threshold for statistical significance was 0.05 level.|ANCOVA|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.7|6.3|<0.001
91522545|NCT04998604|182920089|SUPERIORITY|Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.|LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-1.01|-0.61||The threshold for statistical significance was 0.05 level.|ANCOVA|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.61|-1.01|<0.001
91522546|NCT04998604|182920090|SUPERIORITY|Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.|LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.082|<|0.001|TWO_SIDED|95.0|-0.74|-0.42||The threshold for statistical significance was 0.05 level.|ANCOVA|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.42|-0.74|<0.001
91522547|NCT04998604|182920091|SUPERIORITY|Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.|LS mean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-2.15|-1.33||The threshold for statistical significance was 0.05 level.|ANCOVA|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.33|-2.15|<0.001
91649696|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-18.78|15.18||||||For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||15.18|-18.78|
91649697|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.59|||||TWO_SIDED|95.0|-3.22|36.39||||||For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.39|-3.22|
91649698|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|||||TWO_SIDED|95.0|-5.68|26.47||||||For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||26.47|-5.68|
91649699|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||||TWO_SIDED|95.0|-20.19|23.36||||||For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.36|-20.19|
91649700|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.24|||||TWO_SIDED|95.0|-7.62|40.1||||||For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||40.1|-7.62|
91784785|NCT00669409|183450019|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.1|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-37.1|
91599093|NCT04589988|183089661|SUPERIORITY|||||||0.724||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.724
91599094|NCT04589988|183089662|SUPERIORITY|||||||0.447||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.447
91599095|NCT04589988|183089663|SUPERIORITY|||||||0.696||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.696
91599096|NCT04589988|183089664|SUPERIORITY|||||||0.798||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.798
91599097|NCT04589988|183089665|SUPERIORITY|||||||0.135||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.135
91599098|NCT04589988|183089666|SUPERIORITY|||||||0.291||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.291
91599099|NCT04589988|183089667|SUPERIORITY||Incidence rate ratio|0.83||||0.631|TWO_SIDED|95.0|0.4|1.76|||Negative binomial regression||IRR reflects REBIL intervention group versus control group.|Fall rates were compared between REBIL and control groups using negative binomial regression. The model adjusted for age, sex, ace, and depression score at baseline. The null hypothesis was that fall rates do not differ between groups.||1.76|0.40|0.631
91599100|NCT01202656|183089668|SUPERIORITY_OR_OTHER|||||||0.72|||||||Cochran-Mantel-Haenszel|||||||0.72
91599101|NCT00119158|183089674|NON_INFERIORITY_OR_EQUIVALENCE|modified EASI (eczema area severity index) was considered equivalent if p value was greater than \>0.05|||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91599102|NCT00608985|183089681|SUPERIORITY_OR_OTHER||Median Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-21.8|-8.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-8.8|-21.8|<0.0001
91599103|NCT00608985|183089681|SUPERIORITY_OR_OTHER||Median Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-34.3|-19.5|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-19.5|-34.3|<0.0001
91599104|NCT00608985|183089681|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.8||||0.0376|TWO_SIDED|95.0|-13.5|-0.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-0.3|-13.5|0.0376
91599105|NCT00608985|183089682|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.5||||0.0001|TWO_SIDED|95.0|-20.3|-6.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-6.5|-20.3|0.0001
91599106|NCT00608985|183089682|SUPERIORITY_OR_OTHER||Median Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-27.3|-12.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-12.3|-27.3|<0.0001
91599107|NCT00608985|183089682|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.5||||0.3358|TWO_SIDED|95.0|-3.8|11.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||11.0|-3.8|0.3358
91599108|NCT00608985|183089683|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.3||||0.0186|TWO_SIDED|95.0|-13.3|-1.3|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.3|-13.3|0.0186
91599109|NCT00608985|183089683|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.4||||0.0006|TWO_SIDED|95.0|-16.4|-4.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-4.6|-16.4|0.0006
91784786|NCT00669409|183450020|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-5.1|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.1|
91784787|NCT00669409|183450020|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.4|8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-24.4|
91522548|NCT02623855|182920136|SUPERIORITY|Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.||||||0.6099|||||||t-test, 2 sided|||The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.||||0.6099
91522549|NCT02623855|182920138|SUPERIORITY|||||||0.0085|||||||t-test, 2 sided|||||||0.0085
91522550|NCT02623855|182920140|SUPERIORITY|||||||0.1749|||||||t-test, 2 sided|||||||0.1749
91522551|NCT01972529|182920160|SUPERIORITY||Difference of proportion vs placebo|42.6|||<|0.0001|TWO_SIDED|95.0|27.2|58.1|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion versus (vs) placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||58.1|27.2|<0.0001
91784788|NCT00669409|183450020|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-14.2|18.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.4|-14.2|
91784789|NCT00669409|183450020|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-24.3|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-24.3|
91522552|NCT01972529|182920160|SUPERIORITY||Difference of proportion vs placebo|49.9|||<|0.0001|TWO_SIDED|95.0|31.6|68.2|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||68.2|31.6|<0.0001
91522553|NCT01972529|182920161|SUPERIORITY||Difference of proportion vs placebo|64.7|||<|0.0001|TWO_SIDED|95.0|53.6|75.8|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||75.8|53.6|<0.0001
91522554|NCT01972529|182920161|SUPERIORITY||Difference of percentage vs placebo|67.5|||<|0.0001|TWO_SIDED|95.0|51.6|83.4|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||83.4|51.6|<0.0001
91522555|NCT01972529|182920162|SUPERIORITY||Difference in change of platelet count|27.5|||<|0.0001|TWO_SIDED|95.0|22.5|32.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||32.5|22.5|<0.0001
91522556|NCT01972529|182920162|SUPERIORITY||Difference in change of platelet count|33.0|||<|0.0001|TWO_SIDED|95.0|25.5|41.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||41.5|25.5|<0.0001
91599110|NCT00608985|183089683|SUPERIORITY_OR_OTHER||Median Difference (Net)|-12.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-6.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-6.6|-18.8|<0.0001
91784790|NCT00669409|183450020|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-27.6|14.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.9|-27.6|
91784791|NCT00669409|183450021|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-21.6|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.6|
91784792|NCT00669409|183450021|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
91784793|NCT00669409|183450021|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-21.8|11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-21.8|
91784794|NCT00669409|183450021|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.6|1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.2|-31.6|
91784795|NCT00669409|183450021|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-62.6|-19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-19.0|-62.6|
91599111|NCT00608985|183089684|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.3||||0.0035|TWO_SIDED|95.0|-15.3|-3.0|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-3.0|-15.3|0.0035
91599112|NCT00608985|183089684|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.5||||0.0006|TWO_SIDED|95.0|-15.0|-4.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-4.3|-15.0|0.0006
91599113|NCT00608985|183089684|SUPERIORITY_OR_OTHER||Median Difference (Net)|-16.0|||<|0.0001|TWO_SIDED|95.0|-22.0|-9.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-9.8|-22.0|<0.0001
91599114|NCT00608985|183089685|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.2237|TWO_SIDED|95.0|-11.0|2.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||2.5|-11.0|0.2237
91599115|NCT00608985|183089685|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.0||||0.0607|TWO_SIDED|95.0|-12.3|0.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||0.3|-12.3|0.0607
91599116|NCT00608985|183089685|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.5||||0.0017|TWO_SIDED|95.0|-17.3|-4.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-4.0|-17.3|0.0017
91599117|NCT00608985|183089686|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.1||||0.1187|TWO_SIDED|95.0|-9.1|0.9|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||0.9|-9.1|0.1187
91599118|NCT00608985|183089686|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.1||||0.0017|TWO_SIDED|95.0|-11.5|-2.7|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-2.7|-11.5|0.0017
91649701|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|||||TWO_SIDED|95.0|-17.49|23.02||||||For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.02|-17.49|
91599119|NCT00608985|183089686|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.1||||0.0121|TWO_SIDED|95.0|-10.8|-1.4|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.4|-10.8|0.0121
91599120|NCT02004873|183089714|SUPERIORITY_OR_OTHER||Kaplan-Meier survival probability (%)|96.0|||<|0.0001|TWO_SIDED|98.66|93.3|97.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|z-test, 1-sided||"The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.~The coverage level for the confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis."|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%.~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||97.6|93.3|<0.0001
91599121|NCT02004873|183089715|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|98.3|||<|0.0001|TWO_SIDED|98.66|95.4|99.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is greater than 80%."||99.6|95.4|<0.0001
91599122|NCT02004873|183089716|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|99.6|||<|0.0001|TWO_SIDED|98.66|97.5|100.0||Holm adjustment for multiple comparisons for secondary objectives was used. The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is less than or equal to 85%.~Alternative hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is greater than 85%."||100.0|97.5|<0.0001
91599123|NCT02004873|183089717|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is 0.35. The Micra sensor indicated rate is considered proportional to the workload if the 90% CI for the Kay-Wilkoff slope parameter falls into \[0.65, 1.35\].|Slope|0.864|||<|0.001|TWO_SIDED|90.0|0.768|0.961||Holm adjustment for multiple comparisons for secondary objectives was used. Two One-sided Test (TOST) procedure was used at the 0.05 significance level.|t-test, 1 sided|Two One-sided Test (TOST)|A random effect linear regression model was used to assess if the Micra sensor-indicated rate was proportional to the workload using the Kay-Wilkoff model. The Kay-Wilkoff slope parameter was estimated along with its 90% CI.|Null hypothesis: Kay-Wilkoff slope parameter is \< 0.65 or \> 1.35 Alternative hypothesis: Kay-Wilkoff slope parameter is between 0.65 and 1.35||0.961|0.768|<0.001
91649702|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|||||TWO_SIDED|95.0|-16.29|22.03||||||For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.03|-16.29|
91649703|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-9.81|20.92||||||For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||20.92|-9.81|
91649704|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97|||||TWO_SIDED|95.0|-19.52|7.57||||||For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.57|-19.52|
91784796|NCT00669409|183450022|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.9|12.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.5|-20.9|
91599124|NCT03440814|183089764|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.294||0.1983|TWO_SIDED|95.0|-4.24|0.89|||Mixed Models Analysis|MMRM analysis adjusted for baseline growth hormone use and HQ-CT total score. All available subject data were used with no imputation of missing data.|alpha=0.05 level of significance|||0.89|-4.24|0.1983
91599125|NCT03440814|183089765|SUPERIORITY|||||||0.0294|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.0294
91599126|NCT03440814|183089766|SUPERIORITY|||||||0.4089|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.4089
91599127|NCT03440814|183089767|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.458||0.0225|TWO_SIDED|95.0|-1.95|-0.15|||ANCOVA|ANCOVA adjusted for baseline body fat mass value as a covariate, and randomization stratification variables (as randomized) as factors.||||-0.15|-1.95|0.0225
91599128|NCT03440814|183089768|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|1.481||0.0369|TWO_SIDED|95.0|-6.06|-0.19|||Mixed Models Analysis|Linear mixed model for repeated measurements was used. All available data collected before the March 1, 2020 cutoff from each subject were included.|alpha=0.05 level of significance|||-0.19|-6.06|0.0369
91599129|NCT01437397|183089769|SUPERIORITY_OR_OTHER||Least squares mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.073|0.144|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.144|0.073|<0.0001
91599130|NCT01437397|183089769|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.052|0.123|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.123|0.052|<0.0001
91599131|NCT01437397|183089770|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.017||0.01|TWO_SIDED|95.0|0.011|0.079|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.079|0.011|0.010
91649705|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64|||||TWO_SIDED|95.0|-19.75|8.46||||||For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.46|-19.75|
91599132|NCT01437397|183089770|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.017||0.133|TWO_SIDED|95.0|-0.008|0.06|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.060|-0.008|0.133
91599133|NCT01437397|183089771|SUPERIORITY_OR_OTHER||Least squares mean difference|1.436|STANDARD_ERROR_OF_MEAN|0.297|<|0.0001|TWO_SIDED|95.0|0.854|2.018|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||2.018|0.854|<0.0001
91599134|NCT01437397|183089771|SUPERIORITY_OR_OTHER||Least squares mean difference|1.395|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|0.818|1.972|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||1.972|0.818|<0.0001
91599135|NCT01437397|183089772|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.353|STANDARD_ERROR_OF_MEAN|1.075|<|0.0001|TWO_SIDED|95.0|-6.462|-2.244|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-2.244|-6.462|<0.0001
91599136|NCT01437397|183089772|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.728|STANDARD_ERROR_OF_MEAN|1.066||0.0005|TWO_SIDED|95.0|-5.819|-1.637|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-1.637|-5.819|0.0005
91599137|NCT00866307|183089774|SUPERIORITY_OR_OTHER_LEGACY||Percentage|50.0|||||TWO_SIDED|90.0|35.6|64.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (\<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.||64.4|35.6|
91649706|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.53|||||TWO_SIDED|95.0|-39.11|4.05||||||For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||4.05|-39.11|
91784797|NCT00669409|183450022|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.6|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-32.6|
91784798|NCT00669409|183450022|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
91522557|NCT01889186|182920165|SUPERIORITY||||||<|0.001|||||||Clopper-Pearson exact method|||The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.||||<0.001
91599138|NCT00866307|183089775|SUPERIORITY_OR_OTHER_LEGACY||Percentage|53.3|||||TWO_SIDED|90.0|38.7|67.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (\<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.||67.4|38.7|
91599139|NCT02573155|183089790|SUPERIORITY_OR_OTHER||Least Square Mean|0.111|STANDARD_ERROR_OF_MEAN|0.0265|<|0.0001|TWO_SIDED|95.0|0.0585|0.163|||ANCOVA|||||0.163|0.0585|<0.0001
91599140|NCT02573155|183089790|SUPERIORITY_OR_OTHER||Least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.0272|<|0.0001||95.0|0.156|0.264|||ANCOVA|||||0.264|0.156|<0.0001
91599141|NCT06245551|183089808|OTHER|The analysis is applied to the All-subjects data.|Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-19.78|-15.25|||Mixed Models Analysis|||||-15.25|-19.78|<0.001
91599142|NCT00970853|183089835|NON_INFERIORITY_OR_EQUIVALENCE|The original sample for this study (N=302) was sufficient for an 80% detection of differences in means of at least 1/2 standard deviation. This analysis presents the results of the follow-up of the original sample.||||||0.39||||||non-adjusted for multiple comparisons|t-test, 2 sided|||||||0.39
91599143|NCT00970853|183089836|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.99|||||||t-test, 2 sided|||||||.99
91649707|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.25|||||TWO_SIDED|95.0|-26.5|2.0||||||For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||2.00|-26.5|
91784799|NCT00669409|183450022|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.4|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-28.4|
91599144|NCT00970853|183089837|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.16|||||||t-test, 2 sided|||||||0.16
91522558|NCT00252538|182920178|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||All statistics employed Statistical Package for Social Science (SPSS) 17.0. Analysis of variances were used to compare viral responses in genotypes of interest, employing Scheffe's post-hoc analyses. Repeated-measure mixed-effect analyses were used to compare changes in subjective symptoms over time, including age, gender, and self identified race as covariates. Kaplan-Meier survival analyses examining time until MDD development were compared using theMantel-Cox log rank test.||||>0.05
91599145|NCT00970853|183089838|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.4|||||||t-test, 2 sided|||||||.40
91599146|NCT00970853|183089839|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.56|||||||t-test, 2 sided|||||||.56
91599147|NCT00970853|183089840|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.34|||||||t-test, 2 sided|||||||.34
91599148|NCT00970853|183089841|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.85|||||||t-test, 2 sided|||||||.85
91599149|NCT00970853|183089842|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.61|||||||t-test, 2 sided|||||||.61
91599150|NCT00970853|183089843|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.67|||||||t-test, 2 sided|||||||.67
91599151|NCT06232317|183089854|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||||||0.61
91599152|NCT06232317|183089855|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
91599153|NCT06232317|183089860|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
91599154|NCT01358864|183089861|SUPERIORITY_OR_OTHER||Adjusted percent difference|52.8|||<|0.0001|TWO_SIDED|95.0|42.4|63.2||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||63.2|42.4|<0.0001
91599155|NCT01358864|183089861|SUPERIORITY_OR_OTHER||Adjusted percent difference|48.5|||<|0.0001|TWO_SIDED|95.0|38.2|58.9||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||58.9|38.2|<0.0001
91599156|NCT01358864|183089861|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.4|||||TWO_SIDED|95.0|-6.0|14.9||||||||14.9|-6.0|
91599157|NCT01358864|183089861|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
91599158|NCT01358864|183089861|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
91599159|NCT01358864|183089861|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
91599160|NCT01358864|183089863|SUPERIORITY_OR_OTHER||Adjusted percent difference|54.7|||<|0.0001|TWO_SIDED|95.0|44.4|65.0||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||65.0|44.4|<0.0001
91599161|NCT01358864|183089863|SUPERIORITY_OR_OTHER||Adjusted percent difference|50.4|||<|0.0001|TWO_SIDED|95.0|40.1|60.8||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||60.8|40.1|<0.0001
91599162|NCT01358864|183089863|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.5|||||TWO_SIDED|95.0|-5.8|14.9||||||||14.9|-5.8|
91599163|NCT01358864|183089863|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
91649708|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.99|||||TWO_SIDED|95.0|-23.13|9.15||||||For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||9.15|-23.13|
91784800|NCT00669409|183450022|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-38.8|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-38.8|
91522559|NCT00118716|182920181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|STANDARD_ERROR_OF_MEAN|1.29||0.021|TWO_SIDED|95.0|0.5|5.6||LS Mean Difference, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for maximal percent change in FEV1 following exercise challenge at Week 4.||5.6|0.5|0.021
91599164|NCT01358864|183089863|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
91649709|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|||||TWO_SIDED|95.0|-30.48|16.31||||||For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.31|-30.48|
91649710|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|-5.86|27.63||||||For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.63|-5.86|
91649711|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||||TWO_SIDED|95.0|-24.11|1.91||||||For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||1.91|-24.11|
91649712|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.13|||||TWO_SIDED|95.0|-24.26|14.0||||||For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||14.00|-24.26|
91649713|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.13|||||TWO_SIDED|95.0|-14.18|24.44||||||For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.44|-14.18|
91649714|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|||||TWO_SIDED|95.0|-26.25|13.59||||||For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.59|-26.25|
91599165|NCT01358864|183089863|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
91649715|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.03|||||TWO_SIDED|95.0|-15.26|33.32||||||For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.32|-15.26|
91649716|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-25.71|26.82||||||For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||26.82|-25.71|
91649717|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|-24.07|28.01||||||For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||28.01|-24.07|
91649718|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.48|||||TWO_SIDED|95.0|-5.89|24.86||||||For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.86|-5.89|
91649719|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.01|||||TWO_SIDED|95.0|-43.19|3.17||||||For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||3.17|-43.19|
91649720|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.57|||||TWO_SIDED|95.0|-27.24|10.1||||||For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.10|-27.24|
91649721|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.07|||||TWO_SIDED|95.0|-41.1|8.96||||||For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||8.96|-41.10|
91649722|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.11|||||TWO_SIDED|95.0|-42.72|-5.5||||||For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||-5.50|-42.72|
91649723|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-29.66|10.61||||||For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.61|-29.66|
91649724|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|||||TWO_SIDED|95.0|-47.93|7.46||||||For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||7.46|-47.93|
91784801|NCT00669409|183450023|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-22.2|11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.2|-22.2|
91599166|NCT03194373|183089874|SUPERIORITY|Power to detect a 20% improvement in disease control rate (DCR). Based on historical data, the DCR in R/M HNSCC with single agent platinum therapy is 40%. We hypothesize that addition of Palbociclib will increase DCR at 12 weeks to 60%. Two-stage design. Type I error rate of 0.059 and power of 0.80 when the true response rate is 0.60 with alpha=0.05. The two-stage sample size calculations assume a null probability of 0.40.|Proportion|33.0|||||TWO_SIDED|95.0|13.0|59.0||||||||59|13|
91599167|NCT03194373|183089875|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
91599168|NCT03194373|183089876|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
91599169|NCT00931359|183089884|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Factors of treatment group and analysis center were considered||||||<0.001
91599170|NCT00931359|183089885|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||||||0.019
91784802|NCT00669409|183450023|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
91784803|NCT00669409|183450023|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-15.6|17.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.7|-15.6|
91784804|NCT00669409|183450023|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.0|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-28.0|
91784805|NCT00669409|183450023|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-30.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-30.1|
91784806|NCT00669409|183450024|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.6|12.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.8|-20.6|
91784807|NCT00669409|183450024|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.6|-2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.3|-35.6|
91599171|NCT05568888|183089931|SUPERIORITY|A Bayesian logistic regression model was used to compare all-cause 6-hour mortality rate between the BE1116 and placebo arms. The null hypothesis is rejected if the posterior probability of 6-hour mortality rate difference (BE1116-placebo) being negative is greater than predefined threshold at interim and final analyses (ITT population).|Estimated difference Placebo - BE1116|-2.5||||1.9|TWO_SIDED|95.0|-5.02|-0.13||Reported value reflect a posterior probability difference rather than p-value.|Regression, Logistic||Reported values reflect a 95% Credible Interval rather than a 95% Confidence Interval.|Null hypotheses: The all-cause 6-hour mortality rates in BE1116 is no better than the control.||-0.13|-5.02|1.9
91599172|NCT05568888|183089931|SUPERIORITY|A Bayesian logistic regression model was used to compare all-cause 6-hour mortality rate between the BE1116 and placebo arms. The null hypothesis is rejected if the posterior probability of 6-hour mortality rate difference (BE1116-placebo) being negative is greater than predefined threshold at interim and final analyses (mITT population).|Estimated difference Placebo - BE1116|-2.8||||3.1|TWO_SIDED|95.0|-5.8|0.13||Reported value reflect a posterior probability difference rather than p-value.|Regression, Logistic||Reported values reflect a 95% Credible Interval rather than a 95% Confidence Interval.|Null hypotheses: The all-cause 6-hour mortality rates in BE1116 is no better than the control.||0.13|-5.80|3.1
91599173|NCT05568888|183089932|SUPERIORITY|A Bayesian logistic regression model was used to compare all-cause 24-hour in-hospital mortality rate between the BE1116 and placebo arms. The null hypothesis is rejected if the posterior probability of 24-hour in-hospital mortality rate difference (BE1116-placebo) being negative is greater than predefined threshold at interim and final analyses (mITT population).|Estimated difference Placebo - BE1116|-3.6||||3|TWO_SIDED|95.0|-7.35|0.15||Reported value reflect a posterior probability difference rather than p-value.|Regression, Logistic||Reported values reflect a 95% Credible Interval rather than a 95% Confidence Interval.|Null hypotheses: The all-cause 24-hour in-hospital mortality rates in BE1116 is no better than the control.||0.15|-7.35|3.0
91649725|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|3.23|46.77||||||For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.77|3.23|
91649726|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|||||TWO_SIDED|95.0|-13.49|25.99||||||For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||25.99|-13.49|
91649727|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.64|||||TWO_SIDED|95.0|-7.12|46.41||||||For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.41|-7.12|
91649728|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.02|||||TWO_SIDED|95.0|0.38|43.66||||||For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.66|0.38|
91709421|NCT03951753|183311461|OTHER||Least Squares Mean Difference|11.3|||<|0.001|TWO_SIDED|95.0|4.9|17.7|||ANCOVA|||||17.7|4.9|<0.001
91599174|NCT05568888|183089933|SUPERIORITY|A Bayesian logistic regression model was used to compare all-cause 30 days in-hospital mortality rate between the BE1116 and placebo arms. The null hypothesis is rejected if the posterior probability of 30 days in-hospital mortality rate difference (BE1116-placebo) being negative is greater than predefined threshold at interim and final analyses (mITT population).|Estimated difference Placebo - BE1116|-6.0||||1.4|TWO_SIDED|95.0|-11.42|-0.68||Reported value reflect a posterior probability difference rather than p-value.|Regression, Logistic||Reported values reflect a 95% Credible Interval rather than a 95% Confidence Interval.|Null hypotheses: The all-cause 30 days in-hospital mortality rates in BE1116 is no better than the control.||-0.68|-11.42|1.4
91599175|NCT05568888|183089934|SUPERIORITY|A Bayesian logistic regression model was used to compare difference in proportion of subjects between the BE1116 and placebo arms. The null hypothesis is rejected if the posterior probability of subjects who undergo surgical or interventional radiological procedures to stop bleeding related to the primary injury up to 24 hours difference (BE1116-placebo) being negative is greater than predefined threshold at interim and final analyses (mITT population).|Estimated difference Placebo - BE1116|-2.5||||18.9|TWO_SIDED|95.0|-7.98|3.05||Reported value reflect a posterior probability difference rather than p-value.|Regression, Logistic|||Null hypotheses: The proportion of subjects who undergo surgical or interventional radiological procedures to stop bleeding related to the primary injury up to 24 hours in BE1116 is no better than the control.|Reported values reflect a 95% Credible Interval rather than a 95% Confidence Interval.|3.05|-7.98|18.9
91599176|NCT03784079|183090044|OTHER||Emax|-1.937|||||TWO_SIDED|95.0|-2.484|-1.389||||||||-1.389|-2.484|
91599177|NCT03784079|183090044|OTHER||EC50|7.094|||||TWO_SIDED|95.0|0.585|13.602||||||||13.602|0.585|
91599178|NCT03784079|183090044|OTHER||s2e|0.137|||||TWO_SIDED|95.0|0.062|0.212||||||||0.212|0.062|
91599179|NCT03784079|183090045|OTHER||Emax|-1.929|||||TWO_SIDED|95.0|-2.479|-1.379||||||||-1.379|-2.479|
91599180|NCT03784079|183090045|OTHER||EC50|0.446|||||TWO_SIDED|95.0|0.03|0.861||||||||0.861|0.030|
91599181|NCT03784079|183090045|OTHER||s2e|0.139|||||TWO_SIDED|95.0|0.063|0.216||||||||0.216|0.063|
91599182|NCT03784079|183090046|OTHER||Emax|-1.926|||||TWO_SIDED|95.0|-2.498|-1.354||||||||-1.354|-2.498|
91599183|NCT03784079|183090046|OTHER||EC50|0.197|||||TWO_SIDED|95.0|0.007|0.386||||||||0.386|0.007|
91599184|NCT03784079|183090046|OTHER||s2e|0.144|||||TWO_SIDED|95.0|0.065|0.222||||||||0.222|0.065|
91599185|NCT01844986|183090062|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
91599186|NCT01844986|183090062|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.23|0.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||0.97|0.23|
91599187|NCT01844986|183090063|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8903|TWO_SIDED|95.0|0.6|1.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||1.53|0.60|0.8903
91599188|NCT01844986|183090063|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.29|2.28||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||2.28|0.29|
91599189|NCT01844986|183090064|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.23|<0.0001
91599190|NCT01844986|183090064|SUPERIORITY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.99||Not applicable due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||0.99|0.23|
91599191|NCT01844986|183090065|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.35|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.35|0.0002
91599192|NCT01844986|183090065|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.23|1.35||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.35|0.23|
91599193|NCT01844986|183090066|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.001|TWO_SIDED|95.0|-4.779|-1.216|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||-1.216|-4.779|0.0010
91599194|NCT01844986|183090067|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
91599195|NCT01844986|183090067|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.29|1.23||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.23|0.29|
91599196|NCT01844986|183090068|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.63|0.32|<0.0001
91599197|NCT01844986|183090068|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.25|1.26||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.26|0.25|
91709422|NCT03951753|183311461|OTHER||Least Squares Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1|||ANCOVA|||||26.1|13.4|<0.001
91599198|NCT01844986|183090069|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.51|0.79||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.79|0.51|<0.0001
91599199|NCT01844986|183090069|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.47|1.42||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.42|0.47|
91599200|NCT01844986|183090070|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
91599201|NCT00403260|183090114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction). Non-inferiority of PA to MQ + AS was concluded if the lower limit of the CI for the difference was \>-5%.|ACPR percent difference|1.1||||0.106|TWO_SIDED|95.0|-0.2|3.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test is calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to MQ+AS was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: the PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than -5%."||3.1|-0.2|0.106
91599202|NCT04137887|183090133|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the Confidence intervals (CIs) for relative vaccine effectiveness (rVE); expressed in percentage (%) was more than (\>) 0%.|Relative Vaccine Effectiveness|5.54|||||TWO_SIDED|95.0|-12.43|20.66|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|||20.66|-12.43|
91599203|NCT04137887|183090134|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|5.4|||||TWO_SIDED|95.0|-27.99|30.14|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of respiratory system.||30.14|-27.99|
91599204|NCT04137887|183090134|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|7.09|||||TWO_SIDED|95.0|-15.04|25.0|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of circulatory system.||25.00|-15.04|
91599205|NCT01790503|183090158|OTHER||Hazard Ratio (HR)|0.98||||0.456|TWO_SIDED|95.0|0.71|1.36|||Log Rank|||||1.36|0.71|0.456
91599206|NCT01790503|183090158|OTHER||Hazard Ratio (HR)|1.05||||0.619|TWO_SIDED|95.0|0.77|1.43|||Log Rank|||||1.43|0.77|0.619
91599207|NCT01790503|183090158|OTHER||Hazard Ratio (HR)|0.9||||0.272|TWO_SIDED|95.0|0.65|1.26|||Log Rank|||||1.26|0.65|0.272
91599208|NCT01790503|183090159|OTHER|||||||0.44|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.440
91784808|NCT00669409|183450024|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-19.6|13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.7|-19.6|
91784809|NCT00669409|183450024|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-30.9|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-30.9|
91599209|NCT01790503|183090159|OTHER|||||||0.699|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.699
91599210|NCT01790503|183090159|OTHER|||||||0.003|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.003
91599211|NCT01790503|183090159|OTHER|||||||0.201|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.201
91599212|NCT01790503|183090161|OTHER||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.6|1.47|||Log Rank|||||1.47|0.60|0.389
91599213|NCT01790503|183090161|OTHER||Hazard Ratio (HR)|0.94||||0.393|TWO_SIDED|95.0|0.63|1.42|||Log Rank|||||1.42|0.63|0.393
91599214|NCT01790503|183090161|OTHER||Hazard Ratio (HR)|0.98||||0.469|TWO_SIDED|95.0|0.63|1.54|||Log Rank|||||1.54|0.63|0.469
91599215|NCT01790503|183090162|OTHER|||||||0.063|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.063
91599216|NCT01790503|183090162|OTHER|||||||0.969|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.969
91599217|NCT01790503|183090162|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||<0.001
91599218|NCT01790503|183090162|OTHER|||||||0.501|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.501
91599219|NCT01790503|183090163|OTHER|||||||0.705|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.705
91599220|NCT01790503|183090163|OTHER||||||>|0.999|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||>0.999
91599221|NCT01790503|183090163|OTHER|||||||0.099|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.099
91599222|NCT01790503|183090163|OTHER|||||||0.348|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.348
91599223|NCT04183335|183090168|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.0001|TWO_SIDED|95.0|2.78|15.41||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||15.41|2.78|<0.0001
91599224|NCT04183335|183090169|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0004|TWO_SIDED|95.0|1.81|8.98||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||8.98|1.81|0.0004
91599225|NCT04183335|183090170|SUPERIORITY||Odds Ratio (OR)|6.9|||<|0.0001|TWO_SIDED|95.0|2.49|19.05||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||19.05|2.49|<0.0001
91599226|NCT04183335|183090171|SUPERIORITY||LS mean difference|-26.67|||<|0.0001|TWO_SIDED|95.0|-38.44|-14.9||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-14.90|-38.44|<0.0001
91599227|NCT04183335|183090172|SUPERIORITY||Least square mean difference|-6.19|||<|0.0001|TWO_SIDED|95.0|-8.34|-4.05||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.05|-8.34|<0.0001
91599228|NCT04183335|183090173|SUPERIORITY||Least square mean difference|-2.17|||<|0.0001|TWO_SIDED|95.0|-3.07|-1.28||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.28|-3.07|<0.0001
91599229|NCT04183335|183090174|SUPERIORITY||Least square mean difference|-2.6||||0.0082|TWO_SIDED|95.0|-4.52|-0.67||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.67|-4.52|0.0082
91599230|NCT04183335|183090182|SUPERIORITY||LS mean difference|-0.7||||0.0119|TWO_SIDED|95.0|-1.25|-0.15||Threshold of significance at \<0.05 level.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|||-0.15|-1.25|0.0119
91599231|NCT00049673|183090189|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.18|TWO_SIDED|95.0|0.53|1.14|||Log Rank|||||1.14|0.53|0.18
91599232|NCT00049673|183090190|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|0.0001
91599233|NCT01535729|183090192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949|STANDARD_ERROR_OF_MEAN|0.167||0.756|TWO_SIDED|95.0|0.684|1.318|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.318|0.684|0.756
91784810|NCT00669409|183450024|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-51.2|-7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-51.2|
91784811|NCT00669409|183450025|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.3|17.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.1|-16.3|
91599234|NCT01535729|183090192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|STANDARD_ERROR_OF_MEAN|0.185||0.11|TWO_SIDED|95.0|0.518|1.07|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.070|0.518|0.110
91599235|NCT01535729|183090192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054|STANDARD_ERROR_OF_MEAN|0.242||0.829|TWO_SIDED|95.0|0.656|1.692|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.692|0.656|0.829
91599236|NCT01535729|183090207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.981|STANDARD_ERROR_OF_MEAN|0.143||0.895|TWO_SIDED|95.0|0.741|1.299|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.299|0.741|0.895
91599237|NCT01535729|183090207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689|STANDARD_ERROR_OF_MEAN|0.162||0.022|TWO_SIDED|95.0|0.501|0.947|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||0.947|0.501|0.022
91599238|NCT01535729|183090207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.212||0.479|TWO_SIDED|95.0|0.767|1.759|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.759|0.767|0.479
91599239|NCT01535729|183090208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732|STANDARD_ERROR_OF_MEAN|0.129||0.015|TWO_SIDED|95.0|0.569|0.941|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.941|0.569|0.015
91709423|NCT03951753|183311461|OTHER||Least Squares Mean Difference|8.5||||0.003|TWO_SIDED|95.0|3.0|14.0|||ANCOVA|||||14.0|3.0|0.003
91599240|NCT01535729|183090209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.902|STANDARD_ERROR_OF_MEAN|0.156||0|TWO_SIDED|95.0|1.402|2.582|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.582|1.402|0.000
91599241|NCT01535729|183090209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.786|STANDARD_ERROR_OF_MEAN|0.183||0.002|TWO_SIDED|95.0|1.248|2.557|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.557|1.248|0.002
91599242|NCT01535729|183090212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.535|0.962|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.962|0.535|0.027
91599243|NCT01535729|183090213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.935|STANDARD_ERROR_OF_MEAN|0.179||0|TWO_SIDED|95.0|1.362|2.749|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.749|1.362|0.000
91599244|NCT01535729|183090213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.882|STANDARD_ERROR_OF_MEAN|0.213||0.003|TWO_SIDED|95.0|1.239|2.859|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.859|1.239|0.003
91599245|NCT02889796|183090322|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|20.6|32.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.8|20.6|<0.001
91599246|NCT02889796|183090322|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|13.6|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||26.2|13.6|<0.001
91599247|NCT02889796|183090323|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.36|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.36|<0.001
91599248|NCT02889796|183090323|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.24|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.24|<0.001
91599249|NCT02889796|183090324|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|19.6|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||30.0|19.6|<0.001
91649729|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.12|||||TWO_SIDED|95.0|-18.49|38.73||||||For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-18.49|
91784812|NCT00669409|183450025|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.4|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-35.4|
91784813|NCT00669409|183450025|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.1|9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.1|-24.1|
91784814|NCT00669409|183450025|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.9|0.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.9|-31.9|
91599250|NCT02889796|183090324|SUPERIORITY||Difference in Response Rates|14.5|||<|0.001|TWO_SIDED|95.0|9.7|19.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.3|9.7|<0.001
91599251|NCT02889796|183090324|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using non-responder imputation (NRI).|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12.||||<0.001
91599252|NCT02889796|183090324|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using NRI.||||||0.002||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12.||||0.002
91599253|NCT02889796|183090324|SUPERIORITY||Difference in Response Rates|10.4||||0.001|TWO_SIDED|95.0|3.9|17.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12.||17.0|3.9|0.001
91649730|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-13.98|55.65||||||For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||55.65|-13.98|
91649731|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-19.02|42.83||||||For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.83|-19.02|
91709424|NCT03951753|183311462|OTHER||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-5.5|-1.8|||ANCOVA|||||-1.8|-5.5|<0.001
91599254|NCT02889796|183090324|SUPERIORITY||Difference in Response Rates|0.1||||0.99|TWO_SIDED|95.0|-6.2|6.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12.||6.3|-6.2|0.99
91599255|NCT02889796|183090325|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.43|<0.001
91599256|NCT02889796|183090325|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.078||0.001|TWO_SIDED|95.0|-0.4|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.40|0.001
91599257|NCT02889796|183090326|SUPERIORITY||Difference in Response Rates|26.3|||<|0.001|TWO_SIDED|95.0|20.2|32.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.4|20.2|<0.001
91599258|NCT02889796|183090326|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||21.4|9.4|<0.001
91599259|NCT02889796|183090326|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12||||<0.001
91599260|NCT02889796|183090326|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.||||||0.054||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12||||0.054
91599261|NCT02889796|183090326|SUPERIORITY||Difference in Response Rates|6.3||||0.069|TWO_SIDED|95.0|-1.0|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12||13.6|-1.0|0.069
91599262|NCT02889796|183090326|SUPERIORITY||Difference in Response Rates|-4.6||||0.18|TWO_SIDED|95.0|-11.8|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12||2.6|-11.8|0.18
91599263|NCT02889796|183090327|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|2.8|4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.6|2.8|<0.001
91599264|NCT02889796|183090327|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|2.2|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|2.2|<0.001
91599265|NCT02889796|183090328|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.7|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.7|<0.001
91599266|NCT02889796|183090328|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.5|3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.7|1.5|<0.001
91599267|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|8.0|||<|0.001|TWO_SIDED|95.0|5.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||10.9|5.1|<0.001
91599268|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|4.8|||<|0.001|TWO_SIDED|95.0|2.3|7.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.3|2.3|<0.001
91599269|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|16.4|||<|0.001|TWO_SIDED|95.0|11.9|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||20.9|11.9|<0.001
91599270|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|7.0|||<|0.001|TWO_SIDED|95.0|3.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||10.9|3.1|<0.001
91599271|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|21.4|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||33.3|21.4|<0.001
91599272|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|16.7|||<|0.001|TWO_SIDED|95.0|10.9|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||22.5|10.9|<0.001
91599273|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|24.6|||<|0.001|TWO_SIDED|95.0|18.3|31.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||31.0|18.3|<0.001
91599274|NCT02889796|183090329|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
91599275|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|2.3||||0.008|TWO_SIDED|95.0|0.5|4.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||4.1|0.5|0.008
91599276|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|0.8||||0.18|TWO_SIDED|95.0|-0.5|2.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||2.2|-0.5|0.18
91599277|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|4.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||10.6|4.6|<0.001
91599278|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|1.9||||0.067|TWO_SIDED|95.0|-0.3|4.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||4.0|-0.3|0.067
91599279|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|14.6|24.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||24.1|14.6|<0.001
91599280|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.5|16.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||16.2|7.5|<0.001
91599281|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|21.3|||<|0.001|TWO_SIDED|95.0|15.7|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||26.9|15.7|<0.001
91599282|NCT02889796|183090331|SUPERIORITY||Difference in Response Rates|14.6|||<|0.001|TWO_SIDED|95.0|9.2|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.0|9.2|<0.001
91599283|NCT02889796|183090333|SUPERIORITY||Difference in Response Rates|22.3|||<|0.001|TWO_SIDED|95.0|16.7|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||27.9|16.7|<0.001
91599284|NCT02889796|183090333|SUPERIORITY||Difference in Response Rates|12.6|||<|0.001|TWO_SIDED|95.0|7.2|17.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||17.9|7.2|<0.001
91599285|NCT02889796|183090333|SUPERIORITY||Difference in Response Rates|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||26.1|13.4|<0.001
91599286|NCT02889796|183090333|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|7.5|20.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||20.2|7.5|<0.001
91599287|NCT02889796|183090333|SUPERIORITY||Difference in Response Rates|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||24.9|13.0|<0.001
91599288|NCT02889796|183090333|SUPERIORITY||Difference in Response Rates|18.6|||<|0.001|TWO_SIDED|95.0|12.6|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||24.5|12.6|<0.001
91599289|NCT02889796|183090335|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.22|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.22|<0.001
91599290|NCT02889796|183090335|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.14|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.14|<0.001
91649732|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-16.13|39.94||||||For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||39.94|-16.13|
91649733|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-23.38|23.38||||||For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||23.38|-23.38|
91649734|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66|||||TWO_SIDED|95.0|-34.53|17.21||||||For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups||17.21|-34.53|
91649735|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98|||||TWO_SIDED|95.0|-52.01|26.04||||||For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||26.04|-52.01|
91649736|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.32|||||TWO_SIDED|95.0|-71.87|19.24||||||For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||19.24|-71.87|
91649737|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|||||TWO_SIDED|95.0|-26.59|14.31||||||For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||14.31|-26.59|
91649738|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|95.0|-35.46|11.48||||||For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||11.48|-35.46|
91784815|NCT00669409|183450025|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-53.1|-9.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.5|-53.1|
91784816|NCT00669409|183450026|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.9|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-16.9|
91784817|NCT00669409|183450026|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.7|-3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.4|-36.7|
91599291|NCT02889796|183090335|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.24|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.24|<0.001
91599292|NCT02889796|183090335|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.15|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.15|<0.001
91784818|NCT00669409|183450026|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.2|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-24.2|
91649739|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|||||TWO_SIDED|95.0|-20.97|49.04||||||For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||49.04|-20.97|
91649740|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.39|||||TWO_SIDED|95.0|-15.83|62.61||||||For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.61|-15.83|
91649741|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-30.84|38.73||||||For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-30.84|
91649742|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.56|||||TWO_SIDED|95.0|-13.08|62.2||||||For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.20|-13.08|
91649743|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-38.65|34.94||||||For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||34.94|-38.65|
91649744|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65|||||TWO_SIDED|95.0|-37.43|56.73||||||For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||56.73|-37.43|
91649745|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.16|||||TWO_SIDED|95.0|-71.22|97.54||||||For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||97.54|-71.22|
91649746|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.81|||||TWO_SIDED|95.0|-22.61|68.22||||||For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||68.22|-22.61|
91649747|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||||TWO_SIDED|95.0|-39.1|35.59||||||For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||35.59|-39.10|
91649748|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.98|||||TWO_SIDED|95.0|1.09|46.86||||||For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||46.86|1.09|
91649749|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.04|||||TWO_SIDED|95.0|-39.03|63.11||||||For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||63.11|-39.03|
91649750|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.89|||||TWO_SIDED|95.0|-20.74|58.52||||||For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||58.52|-20.74|
91649751|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.33|||||TWO_SIDED|95.0|-111.94|15.28||||||For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||15.28|-111.94|
91649752|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-22.59|20.74||||||For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.74|-22.59|
91649753|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.22|||||TWO_SIDED|95.0|-24.98|39.43||||||For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||39.43|-24.98|
91649754|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-57.71|77.71||||||For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.71|-57.71|
91599293|NCT02889796|183090335|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.34|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.34|<0.001
91599294|NCT02889796|183090335|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.26|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.26|<0.001
91599295|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
91599296|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.01|TWO_SIDED|95.0|-3.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-3.0|0.010
91599297|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
91599298|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
91599299|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
91784819|NCT00669409|183450026|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.8|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.8|
91784820|NCT00669409|183450026|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-33.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-55.6|-12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-12.0|-55.6|
91784821|NCT00669409|183450027|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-12.9|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-12.9|
91599300|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
91649755|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04|||||TWO_SIDED|95.0|-58.87|24.79||||||For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||24.79|-58.87|
91649756|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|||||TWO_SIDED|95.0|-43.1|13.1||||||For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||13.10|-43.10|
91649757|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-41.75|57.3||||||For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||57.30|-41.75|
91649758|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-53.79|20.46||||||For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.46|-53.79|
91649759|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.11|||||TWO_SIDED|95.0|-73.14|30.92||||||For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.92|-73.14|
91649760|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.22|||||TWO_SIDED|95.0|-115.58|51.13||||||For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||51.13|-115.58|
91599301|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
91599302|NCT02889796|183090337|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91599303|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.002
91599304|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.047|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.047
91599305|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91599306|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91599307|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91649761|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.33|||||TWO_SIDED|95.0|-18.6|125.26||||||For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||125.26|-18.60|
91649762|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|||||TWO_SIDED|95.0|-34.92|41.58||||||For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||41.58|-34.92|
91784822|NCT00669409|183450027|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.5|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-36.5|
91599308|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
91784823|NCT00669409|183450027|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|10.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-23.3|
91784824|NCT00669409|183450027|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.2|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-31.2|
91784825|NCT00669409|183450027|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.2|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.0|-6.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.4|-50.0|
91649763|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.67|||||TWO_SIDED|95.0|-34.3|20.96||||||For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-34.3|
91649764|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-58.94|100.6||||||For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||100.60|-58.94|
91649765|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.33|||||TWO_SIDED|95.0|-44.54|63.2||||||For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||63.20|-44.54|
91649766|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-35.3|75.3||||||For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||75.30|-35.30|
91649767|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-51.66|36.66||||||For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||36.66|-51.66|
91784826|NCT00669409|183450028|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-9.4|24.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.0|-9.4|
91784827|NCT00669409|183450028|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-34.4|-1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.2|-34.4|
91784828|NCT00669409|183450028|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-20.0|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-20.0|
91784829|NCT00669409|183450028|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.9|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-29.9|
91599309|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91599310|NCT02889796|183090339|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
91599311|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-11.0|<0.001
91599312|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
91599313|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
91599314|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
91784830|NCT00669409|183450028|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.3|-6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.7|-50.3|
91784831|NCT00669409|183450029|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.3|29.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.1|-4.3|
91784832|NCT00669409|183450029|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-31.4|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-31.4|
91784833|NCT00669409|183450029|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.6|18.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.6|-14.6|
91599315|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
91649768|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-36.06|69.39||||||For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||69.39|-36.06|
91649769|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-76.36|86.36||||||For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.36|-76.36|
91649770|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.78|||||TWO_SIDED|95.0|-77.63|42.08||||||For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||42.08|-77.63|
91599316|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
91599317|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
91599318|NCT02889796|183090341|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
91649771|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-62.33|28.99||||||For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-62.33|
91784834|NCT00669409|183450029|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-25.0|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-25.0|
91784835|NCT00669409|183450029|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.1|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-44.9|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-44.9|
91784836|NCT00669409|183450030|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.6|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.1|28.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.3|-5.1|
91784837|NCT00669409|183450030|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.1|1.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.1|-32.1|
91784838|NCT00669409|183450030|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.5|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-13.5|
91784839|NCT00669409|183450030|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.1|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-23.1|
91784840|NCT00669409|183450030|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.7|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-40.7|
91784841|NCT00669409|183450031|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.4|29.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.0|-4.4|
91784842|NCT00669409|183450031|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-27.8|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.8|
91784843|NCT00669409|183450031|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
91784844|NCT00669409|183450031|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.9|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-23.9|
91784845|NCT00669409|183450031|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.4|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-40.4|
91784846|NCT00669409|183450032|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.5|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.5|
91784847|NCT00669409|183450032|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.3|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-26.3|
91784848|NCT00669409|183450032|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.7|18.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.5|-14.7|
91784849|NCT00669409|183450032|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.6|9.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.2|-23.6|
91784850|NCT00669409|183450032|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-42.2|1.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.4|-42.2|
91784851|NCT00669409|183450033|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-3.2|30.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||30.2|-3.2|
91784852|NCT00669409|183450033|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|9.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.3|
91599319|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
91599320|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-8.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-8.0|<0.001
91599321|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
91599322|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-9.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-9.0|<0.001
91599323|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
91599324|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
91599325|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
91599326|NCT02889796|183090343|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
91599327|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
91599328|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
91599329|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
91709425|NCT03951753|183311462|OTHER||Least Squares Mean Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-6.3|-2.6|||ANCOVA|||||-2.6|-6.3|<0.001
91784853|NCT00669409|183450033|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-11.5|21.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||21.7|-11.5|
91784854|NCT00669409|183450033|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-24.1|8.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.8|-24.1|
91599330|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-9.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-9.0|<0.001
91599331|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
91599332|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-13.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-13.0|<0.001
91599333|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
91599334|NCT02889796|183090345|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
91784855|NCT00669409|183450033|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-31.6|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-31.6|
91784856|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-24.7|6.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.4|-24.7|
91784857|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-36.0|-4.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-36.0|
91784858|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-19.9|11.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-19.9|
91784859|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.9|-0.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-30.9|
91784860|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-49.4|-8.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.9|-49.4|
91784861|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-16.9|14.3||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.3|-16.9|
91784862|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-29.5|1.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.7|-29.5|
91784863|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-15.4|16.5||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-15.4|
91784864|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-27.3|3.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.7|-27.3|
91784865|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-43.1|-2.4||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.4|-43.1|
91784866|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-33.2|-0.3||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.3|-33.2|
91784867|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-43.7|-10.8||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-10.8|-43.7|
91784868|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-23.4|9.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.4|
91784869|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-35.6|-3.2||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-35.6|
91784870|NCT00669409|183450034|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.4|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-45.8|-2.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-45.8|
91784871|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-18.5|12.6||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.6|-18.5|
91599335|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-10.83|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-12.7|-8.96||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.96|-12.70|<0.001
91599336|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|0.947|<|0.001|TWO_SIDED|95.0|-9.58|-5.87||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.87|-9.58|<0.001
91599337|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-9.39|STANDARD_ERROR_OF_MEAN|0.989|<|0.001|TWO_SIDED|95.0|-11.33|-7.45||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.45|-11.33|<0.001
91599338|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-9.29|-5.42||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.42|-9.29|<0.001
91599339|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-8.02|STANDARD_ERROR_OF_MEAN|0.961|<|0.001|TWO_SIDED|95.0|-9.9|-6.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.13|-9.90|<0.001
91599340|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-8.35|-4.58||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.58|-8.35|<0.001
91599341|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-7.91|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-9.88|-5.93||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.93|-9.88|<0.001
91709426|NCT03951753|183311462|OTHER||Least Squares Mean Difference|-0.8||||0.277|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||||0.7|-2.4|0.277
91784872|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-30.3|0.8||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.3|
91784873|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-3.2|28.1||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.1|-3.2|
91784874|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.4||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-23.1|
91784875|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-23.3|17.2||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.2|-23.3|
91784876|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-14.9|16.3||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.3|-14.9|
91784877|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-25.5|5.7||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.7|-25.5|
91784878|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-3.4|28.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.5|-3.4|
91784879|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-21.9|9.0||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-21.9|
91784880|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-25.2|15.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-25.2|
91784881|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-21.4|11.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.5|-21.4|
91784882|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-30.3|2.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.7|-30.3|
91784883|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-0.6|32.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||32.7|-0.6|
91784884|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-22.9|9.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.5|-22.9|
91784885|NCT00669409|183450035|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-25.5|17.4||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.4|-25.5|
91784886|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-22.9|8.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-22.9|
91784887|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-34.4|-3.3||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-34.4|
91709427|NCT03951753|183311463|OTHER||Slope|-296.1||||0.044|TWO_SIDED|95.0|-584.8|-7.5|||ANCOVA|||||-7.5|-584.8|0.044
91784888|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-25.2|6.1||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.1|-25.2|
91784889|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.8|-0.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-30.8|
91784890|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.9|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-48.1|-7.6||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-48.1|
91784891|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-21.3|9.9||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-21.3|
91784892|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-32.6|-1.4||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.4|-32.6|
91784893|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-24.3|7.5||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-24.3|
91784894|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-32.2|-1.3||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.2|
91784895|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-47.8|-7.1||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.1|-47.8|
91784896|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-25.5|7.4||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-25.5|
91784897|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.1|-3.2||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-36.1|
91784898|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-22.1|11.3||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.3|-22.1|
91599342|NCT02889796|183090347|SUPERIORITY||Least Squares Mean Difference|-6.59|STANDARD_ERROR_OF_MEAN|1.005|<|0.001|TWO_SIDED|95.0|-8.56|-4.62||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.62|-8.56|<0.001
91599343|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|12.3|||<|0.001|TWO_SIDED|95.0|5.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||18.9|5.7|<0.001
91599344|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|6.5||||0.043|TWO_SIDED|95.0|-0.1|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||13.1|-0.1|0.043
91599345|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.8|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||22.8|9.8|<0.001
91599346|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|8.1||||0.011|TWO_SIDED|95.0|1.5|14.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||14.7|1.5|0.011
91784899|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-30.9|1.6||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.9|
91784900|NCT00669409|183450036|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-44.4|-1.5||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.5|-44.4|
91599347|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|21.0|||<|0.001|TWO_SIDED|95.0|14.9|27.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||27.0|14.9|<0.001
91599348|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|13.6|||<|0.001|TWO_SIDED|95.0|7.3|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.9|7.3|<0.001
91599349|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|10.5|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||22.8|10.5|<0.001
91599350|NCT02889796|183090349|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|7.8|20.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||20.3|7.8|<0.001
91599351|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
91784901|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-12.2|18.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.8|-12.2|
91784902|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-27.0|4.1||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.1|-27.0|
91784903|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-17.4|13.9||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-17.4|
91599352|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.5|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.5|<0.001
91599353|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-0.9|<0.001
91599354|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
91599355|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
91613660|NCT02078713|183121545|SUPERIORITY||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.11|2.33||P-value calculated in imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.33|1.11|0.01
91649772|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-79.59|96.26||||||For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-79.59|
91649773|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-89.98|52.94||||||For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||52.94|-89.98|
91649774|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||||TWO_SIDED|95.0|-133.08|93.08||||||For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||93.08|-133.08|
91649775|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.67|||||TWO_SIDED|95.0|-151.27|77.94||||||For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||77.94|-151.27|
91649776|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-72.58|65.91||||||For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||65.91|-72.58|
91649777|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.33|||||TWO_SIDED|95.0|-16.45|163.12||||||For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||163.12|-16.45|
91649778|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-48.23|41.56||||||For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||41.56|-48.23|
91649779|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.62|||||TWO_SIDED|95.0|-74.75|106.0||||||For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||106.00|-74.75|
91784904|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-24.8|5.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.8|-24.8|
91784905|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-39.2|1.3||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.3|-39.2|
91649780|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-17.22|83.89||||||For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||83.89|-17.22|
91649781|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.17|||||TWO_SIDED|95.0|-58.04|66.37||||||For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-58.04|
91649782|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|-28.19|38.61||||||For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||38.61|-28.19|
91649783|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.25|||||TWO_SIDED|95.0|-40.94|103.44||||||For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||103.44|-40.94|
91649784|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.08|||||TWO_SIDED|95.0|-91.02|145.18||||||For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||145.18|-91.02|
91649785|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.28|||||TWO_SIDED|95.0|-99.46|68.9||||||For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||68.90|-99.46|
91649786|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-69.69|19.69||||||For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||19.69|-69.69|
91649787|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-77.4|77.4||||||For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.40|-77.40|
91649788|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-82.89|54.32||||||For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||54.32|-82.89|
91649789|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-87.02|78.69||||||For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||78.69|-87.02|
91649790|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-184.57|134.57||||||For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||134.57|-184.57|
91649791|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||||TWO_SIDED|95.0|-105.73|89.06||||||For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||89.06|-105.73|
91649792|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.17|||||TWO_SIDED|95.0|-29.72|188.06||||||For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||188.06|-29.72|
91649793|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-57.74|49.41||||||For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||49.41|-57.74|
91649794|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-39.62|72.95||||||For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||72.95|-39.62|
91649795|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.62|||||TWO_SIDED|95.0|-6.42|61.66||||||For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||61.66|-6.42|
91784906|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-10.6|20.6||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.6|-10.6|
91784907|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-24.0|7.1||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.1|-24.0|
91784908|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-17.1|14.8||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-17.1|
91784909|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-24.6|6.3||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.3|-24.6|
91599356|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
91599357|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
91599358|NCT02889796|183090351|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
91599359|NCT02889796|183090353|SUPERIORITY||Difference in Response Rates|9.5|||<|0.001|TWO_SIDED|95.0|5.8|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||13.1|5.8|<0.001
91649796|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.19|||||TWO_SIDED|95.0|-29.28|81.66||||||For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||81.66|-29.28|
91649797|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|||||TWO_SIDED|95.0|-63.74|56.6||||||For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||56.6|-63.74|
91784910|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-38.2|2.5||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.5|-38.2|
91784911|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-18.3|14.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.6|-18.3|
91599360|NCT02889796|183090353|SUPERIORITY||Difference in Response Rates|4.5||||0.004|TWO_SIDED|95.0|1.4|7.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.7|1.4|0.004
91599361|NCT02889796|183090353|SUPERIORITY||Difference in Response Rates|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||21.1|11.3|<0.001
91599362|NCT02889796|183090353|SUPERIORITY||Difference in Response Rates|11.2|||<|0.001|TWO_SIDED|95.0|6.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||15.8|6.5|<0.001
91649798|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-31.66|79.28||||||For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.28|-31.66|
91649799|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-53.82|110.96||||||For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.96|-53.82|
91649800|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.16|||||TWO_SIDED|95.0|-94.53|34.21||||||For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||34.21|-94.53|
91649801|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-83.26|49.93||||||For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||49.93|-83.26|
91784912|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.5|-3.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-36.5|
91784913|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-19.5|13.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-19.5|
91784914|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-27.1|5.4||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.1|
91784915|NCT00669409|183450037|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-32.0|10.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-32.0|
91784916|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.0|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-2.5|28.6||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.6|-2.5|
91599363|NCT02889796|183090353|SUPERIORITY||Difference in Response Rates|26.9|||<|0.001|TWO_SIDED|95.0|20.6|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|20.6|<0.001
91599364|NCT02889796|183090353|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
91599365|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|4.4|||<|0.001|TWO_SIDED|95.0|2.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||6.7|2.1|<0.001
91599366|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|1.0||||0.17|TWO_SIDED|95.0|-0.5|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||2.6|-0.5|0.17
91599367|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||14.4|7.1|<0.001
91599368|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|5.8|||<|0.001|TWO_SIDED|95.0|2.6|9.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||9.0|2.6|<0.001
91599369|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|32.2|||<|0.001|TWO_SIDED|95.0|26.4|38.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.0|26.4|<0.001
91599370|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|13.4|24.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||24.6|13.4|<0.001
91784917|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-21.0|10.0||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-21.0|
91599371|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|12.7|||<|0.001|TWO_SIDED|95.0|5.6|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 24.||19.9|5.6|<0.001
91599372|NCT02889796|183090355|SUPERIORITY||Difference in Response Rates|-0.5||||0.88|TWO_SIDED|95.0|-7.5|6.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 24.||6.5|-7.5|0.88
91599373|NCT02889796|183090355|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 24.||||<0.001
91599374|NCT02889796|183090355|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 24.||||<0.001
91599375|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-5.9|-3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.2|-5.9|<0.001
91599376|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-4.3|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.3|<0.001
91599377|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-6.6|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-6.6|<0.001
91599378|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-5.3|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-5.3|<0.001
91649802|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-97.98|88.45||||||For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||88.45|-97.98|
91784918|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-10.4|20.9||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.9|-10.4|
91649803|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-86.68|64.46||||||For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.46|-86.68|
91599379|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-7.3|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.3|<0.001
91599380|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0|-5.8|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-5.8|<0.001
91599381|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-6.9|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-6.9|<0.001
91599382|NCT02889796|183090361|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
91599383|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.1|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.1|<0.001
91599384|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-5.0|<0.001
91599385|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-7.6|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.6|<0.001
91599386|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-6.0|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-6.0|<0.001
91784919|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.5||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-23.1|
91784920|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-29.7|10.8||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.8|-29.7|
91784921|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|14.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-1.3|29.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.8|-1.3|
91784922|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-19.2|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
91784923|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-9.1|22.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.8|-9.1|
91649804|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-55.41|64.93||||||For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.93|-55.41|
91649805|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-129.86|110.82||||||For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.82|-129.86|
91599387|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-8.2|-5.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.4|-8.2|<0.001
91599388|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-6.5|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-6.5|<0.001
91599389|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-7.8|-5.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.3|-7.8|<0.001
91599390|NCT02889796|183090363|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-6.1|-3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.5|-6.1|<0.001
91599391|NCT02889796|183090365|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.042|TWO_SIDED|95.0|-0.77|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.77|0.042
91599392|NCT02889796|183090365|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.039|TWO_SIDED|95.0|-0.77|-0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.02|-0.77|0.039
91599393|NCT02889796|183090366|SUPERIORITY||Difference in non-progression rate|6.6||||0.002|TWO_SIDED|95.0|2.2|11.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||11.1|2.2|0.002
91599394|NCT02889796|183090366|SUPERIORITY||Difference in non-progression rate|3.9||||0.073|TWO_SIDED|95.0|-0.8|8.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||8.6|-0.8|0.073
91599395|NCT02889796|183090366|SUPERIORITY||Difference in non-progression rate|7.0||||0.009|TWO_SIDED|95.0|1.5|12.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||12.5|1.5|0.009
91599396|NCT02889796|183090366|SUPERIORITY||Difference in non-progression rate|5.0||||0.061|TWO_SIDED|95.0|-0.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||10.6|-0.6|0.061
91599397|NCT02889796|183090366|SUPERIORITY||Difference in non-progression rate|5.5||||0.004|TWO_SIDED|95.0|1.6|9.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||9.4|1.6|0.004
91599398|NCT02889796|183090366|SUPERIORITY||Difference in non-progression rate|4.7||||0.012|TWO_SIDED|95.0|0.7|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||8.8|0.7|0.012
91599399|NCT02889796|183090370|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.9|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.9|<0.001
91599400|NCT02889796|183090370|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.0|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|1.0|<0.001
91599401|NCT02889796|183090370|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.1|<0.001
91613661|NCT02078713|183121546|SUPERIORITY||Odds Ratio (OR)|1.11||||0.62|TWO_SIDED|95.0|0.74|1.67||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.67|0.74|0.62
91599402|NCT02889796|183090370|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.0|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.0|<0.001
91599403|NCT02889796|183090374|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|0.9|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.9|<0.001
91599404|NCT02889796|183090374|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.48||0.002|TWO_SIDED|95.0|0.6|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.6|0.002
91599405|NCT02889796|183090374|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.52||0.006|TWO_SIDED|95.0|0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.4|0.006
91599406|NCT02889796|183090374|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.52||0.001|TWO_SIDED|95.0|0.7|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|0.7|0.001
91599407|NCT02889796|183090374|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.086|TWO_SIDED|95.0|-0.1|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.1|0.086
91599408|NCT02889796|183090374|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.12|TWO_SIDED|95.0|-0.2|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-0.2|0.12
91599409|NCT02889796|183090378|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.8|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.8|<0.001
91599410|NCT02889796|183090378|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.2|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|1.2|<0.001
91599411|NCT02889796|183090378|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.5|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.5|<0.001
91599412|NCT02889796|183090378|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.6|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.6|<0.001
91784924|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-25.8|5.1||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-25.8|
91599413|NCT02889796|183090384|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.049|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|0.0|0.049
91599414|NCT02889796|183090384|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.069|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-0.0|0.069
91599415|NCT02889796|183090384|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
91599416|NCT02889796|183090384|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
91599417|NCT02889796|183090384|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.5||0.06|TWO_SIDED|95.0|0.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-0.0|0.060
91599418|NCT02889796|183090384|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.003
91599419|NCT02787863|183090427|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
91599420|NCT02787863|183090428|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
91599421|NCT02479802|183090444|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||<0.0001
91599422|NCT02479802|183090445|OTHER|||||||0.0006|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||0.0006
91599423|NCT01978093|183090456|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-2.12|4.3|||Group difference in proportions|Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached||Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.||4.30|-2.12|
91599424|NCT01978093|183090457|NON_INFERIORITY|Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5|Adjusted GMC ratios|1.21|||||TWO_SIDED|97.5|0.77|1.9|||ANCOVA|GMC adjusted for BS sub-cohorts;97.5% confidence interval calculated for adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 Post dose 3)\& Epoch 002 (Havrix \& Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 \& 002)|GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine||1.90|0.77|
91649806|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05|||||TWO_SIDED|95.0|-117.92|79.82||||||For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.82|-117.92|
91784925|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-28.8|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-28.8|
91599425|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio (Ancova Model: adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.||1.47|0.95|
91599426|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.15|||||TWO_SIDED|97.5|0.93|1.42|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.||1.42|0.93|
91599427|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.08|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.||1.31|0.90|
91599428|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.||1.47|0.95|
91599429|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.29|||||TWO_SIDED|97.5|1.03|1.63|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.||1.63|1.03|
91599430|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.17|||||TWO_SIDED|97.5|0.88|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.||1.55|0.88|
91599431|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.11|||||TWO_SIDED|97.5|0.91|1.34|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.||1.34|0.91|
91649807|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|-6.75|159.13||||||For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||159.13|-6.75|
91649808|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-64.93|55.41||||||For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||55.41|-64.93|
91649809|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.56|||||TWO_SIDED|95.0|-271.74|260.62||||||For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||260.62|-271.74|
91649810|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.56|||||TWO_SIDED|95.0|-166.87|197.98||||||For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||197.98|-166.87|
91649811|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.4|
91784926|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-9.5|23.4||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||23.4|-9.5|
91599432|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.0|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.||1.55|1.00|
91599433|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.9|1.5|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.||1.50|0.90|
91599434|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.24|||||TWO_SIDED|97.5|1.01|1.52|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.||1.52|1.01|
91599435|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.94|1.43|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.||1.43|0.94|
91599436|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.07|||||TWO_SIDED|97.5|0.89|1.29|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.||1.29|0.89|
91599437|NCT01978093|183090458|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.91|1.53|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.||1.53|0.91|
91599438|NCT01978093|183090459|NON_INFERIORITY|Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.0|||||TWO_SIDED|97.5|-3.76|3.91|||Group difference in proportions||To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.||3.91|-3.76|
91784927|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-22.4|10.6||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-22.4|
91784928|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.2|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-4.5|28.9||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.9|-4.5|
91784929|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-25.2|7.2||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.2|
91784930|NCT00669409|183450038|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-22.4|20.5||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.5|-22.4|
91784931|NCT02191865|183450089|SUPERIORITY_OR_OTHER||ratio of the geometric means|215.39|STANDARD_DEVIATION|73.5|||TWO_SIDED|90.0|120.71|384.32|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||384.32|120.71|
91599439|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.04|1.51|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose||1.51|1.04|
91599440|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.83|1.24|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose||1.24|0.83|
91599441|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.1|||||TWO_SIDED|97.5|0.92|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose||1.31|0.92|
91599442|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.06|||||TWO_SIDED|97.5|0.87|1.28|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose||1.28|0.87|
91599443|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.21|||||TWO_SIDED|97.5|1.01|1.44|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose||1.44|1.01|
91599444|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.13|||||TWO_SIDED|97.5|0.94|1.36|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose||1.36|0.94|
91599445|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.93|1.29|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose||1.29|0.93|
91649812|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-275.22|241.89||||||For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||241.89|-275.22|
91709428|NCT03951753|183311463|OTHER||Least Squares Mean Difference|-637.7|||<|0.001|TWO_SIDED|95.0|-925.2|-350.2|||ANCOVA|||||-350.2|-925.2|<0.001
91784932|NCT02191865|183450089|SUPERIORITY_OR_OTHER||Ratio of geometric means|867.13|STANDARD_DEVIATION|45.9|||TWO_SIDED|90.0|572.93|1312.41|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1312.41|572.93|
91522560|NCT00118716|182920182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|0.24|0.58||LS Mean Diff, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for post-dose FEV1 AUC Day 1.||0.58|0.24|<0.001
91599446|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.94|1.33|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose||1.33|0.94|
91599447|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.96|1.41|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose||1.41|0.96|
91599448|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.14|||||TWO_SIDED|97.5|0.97|1.35|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose||1.35|0.97|
91599449|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose||1.31|0.90|
91599450|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.95|1.34|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose||1.34|0.95|
91599451|NCT01978093|183090460|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.22|||||TWO_SIDED|97.5|1.0|1.5|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose||1.50|1.00|
91599452|NCT03124784|183090477|EQUIVALENCE|ARMS\<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS\< 3 % SpO2.|ARMS|0.0|||||TWO_SIDED|||||||||Accuracy Root Mean Square (ARMS)|Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.|||
91599453|NCT01784965|183090482|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91599454|NCT04161495|183090507|NON_INFERIORITY|Non-inferiority would be established if the upper bound of the one-sided 97.5% CI was less than 4.|Mean difference|-2.3|||||TWO_SIDED|95.0|-3.49|-1.11||||||Hierarchical testing framework: used to control type I error for secondary OM analyses. Statistical testing of Arm A intra-participant comparison non-inferiority continued only when estimation of previous OM was statistically significant at 0.05 level. For Arm A intra-participant comparison, mean difference and 95% confidence interval (CI) were estimated by NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis vs historical prophylaxis) was treated as covariate.||-1.11|-3.49|
91599455|NCT04161495|183090509|SUPERIORITY|Superiority was declared if the upper bound of the one-sided 97.5% confidence interval was less than 1.|Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.13|0.42|||Negative binomial regression mode|||Tested according to hierarchical testing procedure (only performed if the previous OM was statistically significant for the considered dosing regimen). For test about Arm A intra-participant comparison superiority, rate ratio and 95% CI were estimated using NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis) was treated as covariate.||0.42|0.13|<0.0001
91613662|NCT02078713|183121547|SUPERIORITY||Relative risk ratio|1.1||||0.85|TWO_SIDED|95.0|0.4|3.04||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had been less involved to right amount (ref)||3.04|0.40|0.85
91599456|NCT04161495|183090511|SUPERIORITY||LS mean difference|-6.74|STANDARD_ERROR_OF_MEAN|1.71||0.0001|TWO_SIDED|95.0|-10.13|-3.36|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Annualized Bleeding Rate During the Efficacy Period in Prophylaxis Arm - Superiority Analysis\] was statistically significant for considered dosing regimen). Least square (LS) mean difference, standard error and 95% confidence interval were estimated by mixed-effect model with repeated measures (MMRM) using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-3.36|-10.13|0.0001
91599457|NCT04161495|183090512|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.67||0.0042|TWO_SIDED|95.0|-3.26|-0.63|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Change From Baseline in Haem-A-QOL Physical Health Score at Weeks 26 and 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and PROMIS Pain Intensity 3a score as covariate.||-0.63|-3.26|0.0042
91784933|NCT02191865|183450090|SUPERIORITY_OR_OTHER||ratio of the geometric means|221.76|STANDARD_DEVIATION|61.4|||TWO_SIDED|90.0|134.73|365.01|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||365.01|134.73|
91790462|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91599458|NCT04161495|183090513|SUPERIORITY||LS mean difference|-1.54|STANDARD_ERROR_OF_MEAN|0.59||0.0101|TWO_SIDED|95.0|-2.7|-0.37||An unstructured covariance matrix within a participant was used.|Unstructured covariance matrix|||Testing according to hierarchical testing procedure (only performed if previous OM \[Change From Baseline in PROMIS Pain Intensity 3a First Item at Week 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-0.37|-2.70|0.0101
91599459|NCT01764633|183090554|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.0001|TWO_SIDED|95.0|0.79|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|The primary endpoint was compared between treatment groups at a significance level of 0.05.||0.92|0.79|< 0.0001
91599460|NCT01764633|183090555|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.73|0.88|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.||0.88|0.73|< 0.0001
91599461|NCT01764633|183090556|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6188|TWO_SIDED|95.0|0.88|1.25|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.||1.25|0.88|0.6188
91599462|NCT01764633|183090557|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5368|TWO_SIDED|95.0|0.91|1.19|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.||1.19|0.91|0.5368
91599463|NCT01764633|183090558|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.82|0.65|< 0.0001
91599464|NCT01764633|183090559|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0101|TWO_SIDED|95.0|0.66|0.95|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.95|0.66|0.0101
91599465|NCT01764633|183090560|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.71|0.86|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.86|0.71|< 0.0001
91613663|NCT02078713|183121547|SUPERIORITY||Relative risk ratio|1.6||||0.24|TWO_SIDED|95.0|0.73|3.5||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)||3.50|0.73|0.24
91649813|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-307.94|319.05||||||For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.05|-307.94|
91649814|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.40|
91649815|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.81|||||TWO_SIDED|95.0|-215.01|244.64||||||For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||244.64|-215.01|
91649816|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-302.38|324.6||||||For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||324.60|-302.38|
91649817|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-305.85|383.63||||||For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||383.63|-305.85|
91784934|NCT02191865|183450090|SUPERIORITY_OR_OTHER||Ratio of geometric means|761.01|STANDARD_DEVIATION|69.1|||TWO_SIDED|90.0|439.01|1319.18|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1319.18|439.01|
91599466|NCT01764633|183090561|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8179|TWO_SIDED|95.0|0.86|1.13|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||1.13|0.86|0.8179
91599467|NCT01764633|183090562|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0035|TWO_SIDED|95.0|0.65|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.92|0.65|0.0035
91599468|NCT02123485|183090570|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
91790463|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.227||0.217|TWO_SIDED|95.0|-0.727|0.166||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.166|-0.727|0.217
91599469|NCT03545906|183090572|SUPERIORITY||Mean Difference (Net)|1.0||||0.075|TWO_SIDED||||||t-test, 2 sided|||||||.075
91599470|NCT03545906|183090573|SUPERIORITY||Mean Difference (Net)|1.3||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||.018
91599471|NCT03545906|183090574|SUPERIORITY||Mean Difference (Net)|1.2||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||.039
91599472|NCT03545906|183090575|SUPERIORITY||Mean Difference (Net)|0.7||||0.265|TWO_SIDED||||||t-test, 2 sided|||||||.265
91599473|NCT03423342|183090582|SUPERIORITY||Mean Difference (Net)|30.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001|TWO_SIDED|||||The updated p-value is calculated and not a threshold for statistical significance.|t-test, 2 sided|||||||<0.0001
91599474|NCT03423342|183090583|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91599475|NCT03423342|183090584|SUPERIORITY||Mean Difference (Net)|19.0|STANDARD_ERROR_OF_MEAN|48.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91599476|NCT03423342|183090585|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|17.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91599477|NCT03423342|183090586|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|3.1|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91599478|NCT03423342|183090587|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.66|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91599479|NCT03728309|183090677|SUPERIORITY||Percentage Difference|53.5|||<|0.001|TWO_SIDED|95.0|43.5|63.5||The p-value and 95% CI are computed by pooling 30 imputed data sets using SAS PROC MIANALYZE with normal approximation.|SAS PROC MIANALYZE|||||63.5|43.5|<0.001
91649818|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-355.85|333.63||||||For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||333.63|-355.85|
91649819|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-322.52|366.97||||||For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||366.97|-322.52|
91649820|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
91649821|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-165.61|165.61||||||For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.61|-165.61|
91649822|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|-17.84|173.39||||||For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||173.39|-17.84|
91649823|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-106.73|84.5||||||For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||84.5|-106.73|
91649824|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.17|||||TWO_SIDED|95.0|-512.66|404.33||||||For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.||404.33|-512.66|
91649825|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||||TWO_SIDED|95.0|-143.36|3.36||||||For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.||3.36|-143.36|
91599480|NCT03728309|183090679|SUPERIORITY||Mean Difference (Final Values)|28.0|STANDARD_ERROR_OF_MEAN|3.83|<|0.001|TWO_SIDED|95.0|21.0|36.0|||2-sample, t-test|||||36.0|21.0|<0.001
91599481|NCT03728309|183090680|SUPERIORITY||Percentage Difference|52.9|||<|0.001|TWO_SIDED|95.0|40.1|65.7|||Fisher's Exact Test||Comparison of treatment group versus control group at Month 1, responder rate difference, 95% CI for risk difference and p-value was estimated based on Fisher's exact test using mITT population with baseline AFLS score of 2 or 3 on both cheeks.|||65.7|40.1|<0.001
91599482|NCT02342015|183090682|OTHER||||||<|0.05|||||||wilcoxon signed-rank test|||||||<0.05
91599483|NCT02342015|183090683|OTHER||||||<|0.05|||||||paired Student's t-test|||||||<0.05
91599484|NCT01849770|183090693|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.4||0.561|TWO_SIDED|95.0|-1.03|0.56|||Random slopes model|||||0.56|-1.03|0.561
91599485|NCT01849770|183090693|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.43||0.662|TWO_SIDED|95.0|-1.04|0.66|||Random slopes model|||||0.66|-1.04|0.662
91599486|NCT01849770|183090694|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.71|STANDARD_ERROR_OF_MEAN|1.25||0.178|TWO_SIDED|95.0|-0.8|4.22|||Random slopes model|||||4.22|-0.80|0.178
91599487|NCT01849770|183090694|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.94|STANDARD_ERROR_OF_MEAN|1.42||0.51|TWO_SIDED|95.0|-3.8|1.91|||Random slopes model|||||1.91|-3.80|0.510
91784935|NCT02191865|183450091|SUPERIORITY_OR_OTHER||ratio of the geometric means|216.79|STANDARD_DEVIATION|75.0|||TWO_SIDED|90.0|120.37|390.45|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||390.45|120.37|
91790464|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91599488|NCT03403205|183090700|OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|1.14|2.13||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||2.13|1.14|< 0.0001
91599489|NCT03403205|183090700|OTHER||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|0.584|<|0.0001|TWO_SIDED|95.0|2.65|4.94||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||4.94|2.65|< 0.0001
91599490|NCT05130463|183090716|OTHER|||||||0.0011||||||Comparison of the change in HbA1c from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0011
91599491|NCT05130463|183090717|OTHER|||||||0.0014||||||Comparison of the change in HbA1c from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0014
91599492|NCT05130463|183090722|OTHER|||||||0.0008||||||Comparison of the change in FPG from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 12 weeks of treatment.||||0.0008
91599493|NCT05130463|183090723|OTHER|||||||0.0068||||||Comparison of the change in FPG from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 24 weeks of treatment.||||0.0068
91599494|NCT05130463|183090724|OTHER|||||||0.1867||||||Comparison of the change in body weight from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level||Body weight at baseline vs Body weight after 12 weeks of treatment.||||0.1867
91599495|NCT05130463|183090725|OTHER|||||||0.0003||||||Comparison of the change in body weight from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||Body weight at baseline vs Body weight after 24 weeks of treatment.||||0.0003
91599496|NCT05130463|183090726|OTHER|||||||0.002||||||Comparison of the change in SBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 12 weeks of treatment.||||0.0020
91599497|NCT05130463|183090726|OTHER|||||||0.0132||||||Comparison of the change in DBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 12 weeks of treatment.||||0.0132
91599498|NCT05130463|183090727|OTHER|||||||0.7591||||||Comparison of the change in SBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 24 weeks of treatment.||||0.7591
91599499|NCT05130463|183090727|OTHER|||||||0.5161||||||Comparison of the change in DBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 24 weeks of treatment.||||0.5161
91599500|NCT00487539|183090740|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91599501|NCT00487539|183090740|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91599502|NCT00487539|183090741|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91599503|NCT00487539|183090741|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91599504|NCT00487539|183090742|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Chi-squared|||||||0.0014
91599505|NCT00487539|183090742|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
91599506|NCT00487539|183090743|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
91599507|NCT00487539|183090743|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
91599508|NCT01844895|183090766|SUPERIORITY_OR_OTHER||geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||A mixed-effect model of log (Cminss) with device and substudy baseline weight category (\< 60 kg,60-100 kg, \> 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.||1.00|0.83|
91599509|NCT01318109|183090772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.751|||||TWO_SIDED|95.0|-0.923|-0.579||||||||-0.579|-0.923|
91599510|NCT01318109|183090772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.858|||||TWO_SIDED|95.0|-1.019|-0.697||||||||-0.697|-1.019|
91599511|NCT01318109|183090773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|||||TWO_SIDED|95.0|-0.247|-0.135||||||||-0.135|-0.247|
91599512|NCT01318109|183090773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.242|-0.143||||||||-0.143|-0.242|
91599513|NCT01318109|183090774|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.386|||||TWO_SIDED|95.0|-0.469|-0.303||||||||-0.303|-0.469|
91599514|NCT01318109|183090774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|||||TWO_SIDED|95.0|-0.484|-0.323||||||||-0.323|-0.484|
91599515|NCT01318109|183090775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.621|||||TWO_SIDED|95.0|-0.757|-0.486||||||||-0.486|-0.757|
91599516|NCT01318109|183090775|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.692|||||TWO_SIDED|95.0|-0.814|-0.569||||||||-0.569|-0.814|
91599517|NCT01318109|183090776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.26|||||TWO_SIDED|95.0|-26.12|-12.4||||||||-12.40|-26.12|
91599518|NCT01318109|183090776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.27|||||TWO_SIDED|95.0|-30.43|-16.12||||||||-16.12|-30.43|
91599519|NCT01318109|183090777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||||TWO_SIDED|95.0|-24.54|-10.66||||||||-10.66|-24.54|
91599520|NCT01318109|183090777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.35|||||TWO_SIDED|95.0|-28.32|-14.39||||||||-14.39|-28.32|
91599521|NCT01318109|183090778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.87|||||TWO_SIDED|95.0|-25.95|-11.79||||||||-11.79|-25.95|
91599522|NCT01318109|183090778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||||TWO_SIDED|95.0|-25.43|-10.9||||||||-10.90|-25.43|
91599523|NCT01318109|183090779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.24|||||TWO_SIDED|95.0|-26.32|-10.16||||||||-10.16|-26.32|
91599524|NCT01318109|183090779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.38|||||TWO_SIDED|95.0|-30.87|-13.88||||||||-13.88|-30.87|
91599525|NCT01318109|183090780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|||||TWO_SIDED|95.0|-20.14|2.37||||||||2.37|-20.14|
91599526|NCT01318109|183090780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.41|||||TWO_SIDED|95.0|-16.34|3.52||||||||3.52|-16.34|
91599527|NCT06485479|183090781|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599528|NCT06485479|183090781|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599529|NCT06485479|183090781|SUPERIORITY|||||||0.56|||||||Regression, Linear|||||||.56
91599530|NCT06485479|183090782|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599531|NCT06485479|183090782|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599532|NCT06485479|183090782|SUPERIORITY|||||||0.35|||||||Regression, Linear|||||||.35
91599533|NCT06485479|183090783|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599534|NCT06485479|183090783|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599535|NCT06485479|183090783|SUPERIORITY|||||||0.62|||||||Regression, Linear|||||||.62
91599536|NCT06485479|183090784|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||.03
91599537|NCT06485479|183090784|SUPERIORITY|||||||0.17|||||||Regression, Linear|||||||.17
91599538|NCT06485479|183090784|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||.33
91599539|NCT06485479|183090785|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599540|NCT06485479|183090785|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91599541|NCT06485479|183090785|SUPERIORITY|||||||0.38|||||||Regression, Linear|||||||.38
91599542|NCT06485479|183090786|SUPERIORITY|||||||0.6|||||||Regression, Linear|||||||.6
91599543|NCT06485479|183090786|SUPERIORITY|||||||0.65|||||||Regression, Linear|||||||.65
91599544|NCT06485479|183090786|SUPERIORITY|||||||0.4|||||||Regression, Linear|||||||.4
91599545|NCT06142643|183090787|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
91599546|NCT06142643|183090788|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
91599547|NCT04982250|183090796|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-26.0|11.0|||||Risk differences (RD) with 95% confidence intervals (CI) were estimated using regression models with Gaussian distributions, identify links, study group fixed effects, and index peer random effects (to adjust for clustering).|The sample size calculation was based on the primary PrEP initiation outcome at follow-up; 80 clusters (40 per study group) provided 80% power to detect a 17% difference in PrEP initiation between the enhanced (80%) and standard (63%) groups, assuming three referred peers per cluster (75% of those recommended), an intra-cluster correlation coefficient of 0.05, and an alpha level of 0.05.||11|-26|
91599548|NCT04982250|183090801|SUPERIORITY||Risk Difference (RD)|39.0|||||TWO_SIDED|95.0|24.0|54.0||||||||54|24|
91599549|NCT04982250|183090802|SUPERIORITY||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-10.0|13.0||||||||13|-10|
91599550|NCT04982250|183090803|SUPERIORITY||Risk Difference (RD)|-19.0|||||TWO_SIDED|95.0|-40.0|2.0||||||||2|-40|
91599551|NCT04982250|183090804|SUPERIORITY||Median Difference (Final Values)|-16.9|||||TWO_SIDED|95.0|-36.3|2.5||||||||2.5|-36.3|
91599552|NCT04982250|183090805|SUPERIORITY||Median Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.1||||||||1.1|-0.2|
91599553|NCT04685876|183090812|SUPERIORITY|||||||0.355|||||||Regression, Linear|||||||0.355
91599554|NCT04685876|183090812|SUPERIORITY|||||||0.578|||||||Regression, Linear|||||||0.578
91599555|NCT04685876|183090814|SUPERIORITY|||||||0.248|||||||Regression, Cox|||||||0.248
91599556|NCT04685876|183090814|SUPERIORITY|||||||0.297|||||||Regression, Cox|||||||0.297
91599557|NCT04685876|183090815|SUPERIORITY|||||||0.748|||||||Mixed Models Analysis|||||||0.748
91599558|NCT04685876|183090815|SUPERIORITY|||||||0.395|||||||Mixed Models Analysis|||||||0.395
91599559|NCT04685876|183090816|SUPERIORITY|||||||0.152|||||||Regression, Linear|||||||0.152
91599560|NCT04685876|183090816|SUPERIORITY|||||||0.482|||||||Regression, Linear|||||||0.482
91599561|NCT02392429|183090817|NON_INFERIORITY|we tested the null hypothesis that the NPV of the post-treatment FLT PET/CT scan was less than or equal to the NPV of the day 14 nadir bone marrow biopsy (estimated to be 0.64 by Hussein et al) against the one-sided alternative hypothesis that the NPV was greater than 0.64 using the exact binomial test.|||||>|0.99|||||||binomial exact test|||||||>0.99
91599562|NCT02392429|183090818|NON_INFERIORITY|we tested the null hypothesis that the PPV of the post-treatment FLT PET/CT scan was less than or equal to the PPV of the day 14 nadir bone marrow biopsy (estimated to be 0.79by Hussein et al) against the one-sided alternative hypothesis that the PPV was greater than 0.79 using the exact binomial test.||||||0.06|||||||binomial exact test|||||||0.06
91599563|NCT02392429|183090822|EQUIVALENCE|no margin was assumed||||||0.68|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.68
91599564|NCT02392429|183090823|EQUIVALENCE|no margin was assumed||||||0.08|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.08
91599565|NCT02322710|183090866|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 95% confidence interval of the observed difference between healing rates at D21 (Urgotul® - Tullegras M.S.®) in the PP population did not exceed +10%.|Difference in Percentages|1.2|STANDARD_DEVIATION|4.5|||ONE_SIDED|97.5||10.0||||||||10.0||
91599566|NCT05064059|183090883|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4183|TWO_SIDED|95.0|0.8|1.2||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.20|0.80|0.4183
91599567|NCT05064059|183090884|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.9967|TWO_SIDED|95.0|1.09|1.64||One-sided nominal p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.64|1.09|0.9967
91599568|NCT05064059|183090885|SUPERIORITY||Difference in percentage|5.9||||0.0007|TWO_SIDED|95.0|2.5|10.1||One-sided, nominal p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||10.1|2.5|0.0007
91599569|NCT05064059|183090889|OTHER||Difference in Least Square (LS) Means|-3.08||||0.1318|TWO_SIDED|95.0|-7.09|0.93||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||0.93|-7.09|0.1318
91599570|NCT05064059|183090890|OTHER||Difference in LS Means|-0.95||||0.637|TWO_SIDED|95.0|-4.93|3.02||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||3.02|-4.93|0.6370
91599571|NCT05064059|183090891|OTHER||Difference in LS Means|3.86||||0.1846|TWO_SIDED|95.0|-1.85|9.57||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||9.57|-1.85|0.1846
91599572|NCT05064059|183090892|OTHER||Difference in LS Means|0.56||||0.841|TWO_SIDED|95.0|-4.96|6.08||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||6.08|-4.96|0.8410
91599573|NCT05064059|183090893|OTHER||Hazard Ratio (HR)|1.0||||0.5094|TWO_SIDED|95.0|0.64|1.58||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.58|0.64|0.5094
91649826|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-400.13|333.46||||||For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.||333.46|-400.13|
91709429|NCT03951753|183311463|OTHER||Least Squares Mean Difference|-341.6||||0.006|TWO_SIDED|95.0|-585.2|-97.9|||ANCOVA|||||-97.9|-585.2|0.006
91599574|NCT05064059|183090894|OTHER||Hazard Ratio (HR)|1.51||||0.9704|TWO_SIDED|95.0|0.98|2.33||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.33|0.98|0.9704
91649827|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67|||||TWO_SIDED|95.0|-591.86|508.53||||||For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.||508.53|-591.86|
91649828|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.67|||||TWO_SIDED|95.0|-66.67|-66.67||||||For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.||-66.67|-66.67|
91599575|NCT05064059|183090895|OTHER||Hazard Ratio (HR)|1.82||||0.9905|TWO_SIDED|95.0|1.11|2.98||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.98|1.11|0.9905
91599576|NCT05064059|183090896|OTHER||Hazard Ratio (HR)|1.86||||0.9853|TWO_SIDED|95.0|1.06|3.26||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization|||3.26|1.06|0.9853
91599577|NCT04401267|183090937|SUPERIORITY|||||||0.7139|||||||Fisher Exact|||||||0.7139
91599578|NCT02066792|183090951|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.81|-0.21||two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||At 3 month follow-up||-.21|-.81|<.001
91599579|NCT02066792|183090951|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.635|TWO_SIDED|95.0|-0.37|0.23||Two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||.23|-.37|.635
91599580|NCT02066792|183090951|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.8|-0.18|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||||-.18|-.80|.002
91599581|NCT02066792|183090951|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.73|-0.14|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.14|-.73|.004
91599582|NCT02066792|183090951|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.16||0.008|TWO_SIDED|95.0|-0.72|-0.11|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.11|-.72|.008
91599583|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.34|||||TWO_SIDED|90.0|66.05|149.43||||||Buprenorphine||149.43|66.05|
91649829|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|||||TWO_SIDED|95.0|-450.13|283.46||||||For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.||283.46|-450.13|
91599584|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|163.88|||||TWO_SIDED|90.0|110.82|242.34||||||Buprenorphine||242.34|110.82|
91599585|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|281.43|||||TWO_SIDED|90.0|187.1|423.33||||||Buprenorphine||423.33|187.10|
91599586|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.43|||||TWO_SIDED|90.0|52.14|117.98||||||Buprenorphine||117.98|52.14|
91599587|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.66|||||TWO_SIDED|90.0|81.87|195.97||||||Buprenorphine||195.97|81.87|
91599588|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|208.94|||||TWO_SIDED|90.0|137.21|318.18||||||Buprenorphine||318.18|137.21|
91599589|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|358.83|||||TWO_SIDED|90.0|231.92|555.17||||||Buprenorphine||555.17|231.92|
91599590|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.09|||||TWO_SIDED|90.0|44.03|138.49||||||Norbuprenorphine||138.49|44.03|
91599591|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.78|||||TWO_SIDED|90.0|39.26|142.41||||||Norbuprenorphine||142.41|39.26|
91599592|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|11.45|||||TWO_SIDED|90.0|6.35|20.66||||||Norbuprenorphine||20.66|6.35|
91599593|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|71.08|||||TWO_SIDED|90.0|39.0|129.49||||||Norbuprenorphine||129.49|39.00|
91599594|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|109.9|||||TWO_SIDED|90.0|58.14|207.75||||||Norbuprenorphine||207.75|58.14|
91649830|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-177.86|311.2||||||For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.||311.2|-177.86|
91649831|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-333.46|400.13||||||For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.||400.13|-333.46|
91649832|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in pain at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
91649833|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
91649834|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
91599595|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.23|||||TWO_SIDED|90.0|52.17|212.24||||||Norbuprenorphine||212.24|52.17|
91599596|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|16.12|||||TWO_SIDED|90.0|8.4|30.94||||||Norbuprenorphine||30.94|8.40|
91599597|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.3|||||TWO_SIDED|90.0|40.03|157.12||||||Naloxone||157.12|40.03|
91599598|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|317.58|||||TWO_SIDED|90.0|164.93|611.54||||||Naloxone||611.54|164.93|
91599599|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1401.85|||||TWO_SIDED|90.0|707.55|2777.46||||||Naloxone||2777.46|707.55|
91599600|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.78|||||TWO_SIDED|90.0|53.39|209.59||||||Naloxone||209.59|53.39|
91599601|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.97|||||TWO_SIDED|90.0|36.09|155.71||||||Naloxone||155.71|36.09|
91599602|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|300.22|||||TWO_SIDED|90.0|148.44|607.21||||||Naloxone||607.21|148.44|
91599603|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1325.22|||||TWO_SIDED|90.0|638.03|2752.55||||||Naloxone||2752.55|638.03|
91599604|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|85.87|||||TWO_SIDED|90.0|66.06|111.61||||||Naloxone-3-β-D-Glucuronide||111.61|66.06|
91599605|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|123.77|||||TWO_SIDED|90.0|96.27|159.13||||||Naloxone-3-β-D-Glucuronide||159.13|96.27|
91599606|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|91.26|||||TWO_SIDED|90.0|70.21|118.62||||||Naloxone-3-β-D-Glucuronide||118.62|70.21|
91784936|NCT02191865|183450091|SUPERIORITY_OR_OTHER||Ratio of geometric means|870.74|STANDARD_DEVIATION|45.7|||TWO_SIDED|90.0|576.36|1315.49|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1315.49|576.36|
91599607|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.78|||||TWO_SIDED|90.0|65.23|110.2||||||Naloxone-3-β-D-Glucuronide||110.20|65.23|
91599608|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.28|||||TWO_SIDED|90.0|76.52|134.06||||||Naloxone-3-β-D-Glucuronide||134.06|76.52|
91599609|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|145.99|||||TWO_SIDED|90.0|111.43|191.26||||||Naloxone-3-β-D-Glucuronide||191.26|111.43|
91599610|NCT01846455|183090952|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.64|||||TWO_SIDED|90.0|81.33|142.47||||||Naloxone-3-β-D-Glucuronide||142.47|81.33|
91599611|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|120.02|||||TWO_SIDED|90.0|83.35|172.82||||||Buprenorphine||172.82|83.35|
91599612|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.85|||||TWO_SIDED|90.0|75.85|153.36||||||Buprenorphine||153.36|75.85|
91599613|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|171.76|||||TWO_SIDED|90.0|117.93|250.15||||||Buprenorphine||250.15|117.93|
91599614|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|112.82|||||TWO_SIDED|90.0|77.66|163.91||||||Buprenorphine||163.91|77.66|
91599615|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.38|||||TWO_SIDED|90.0|71.43|158.43||||||Buprenorphine||158.43|71.43|
91599616|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|95.59|||||TWO_SIDED|90.0|64.36|141.99||||||Buprenorphine||141.99|64.36|
91599617|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|152.24|||||TWO_SIDED|90.0|103.08|224.83||||||Buprenorphine||224.83|103.08|
91599618|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|135.17|||||TWO_SIDED|90.0|75.44|242.16||||||Norbuprenorphine||242.16|75.44|
91599619|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|67.87|||||TWO_SIDED|90.0|38.82|118.68||||||Norbuprenorphine||118.68|38.82|
91599620|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|48.39|||||TWO_SIDED|90.0|27.01|86.69||||||Norbuprenorphine||86.69|27.01|
91599621|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|76.59|||||TWO_SIDED|90.0|42.75|137.22||||||Norbuprenorphine||137.22|42.75|
91599622|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|176.48|||||TWO_SIDED|90.0|94.62|329.17||||||Norbuprenorphine||329.17|94.62|
91599623|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|88.62|||||TWO_SIDED|90.0|48.6|161.59||||||Norbuprenorphine||161.59|48.60|
91599624|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|63.17|||||TWO_SIDED|90.0|33.87|117.83||||||Norbuprenorphine||117.83|33.87|
91599625|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|100.41|||||TWO_SIDED|90.0|51.3|196.53||||||Naloxone||196.53|51.30|
91599626|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|270.0|||||TWO_SIDED|90.0|141.86|513.9||||||Naloxone||513.90|141.86|
91599627|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1129.81|||||TWO_SIDED|90.0|577.22|2211.44||||||Naloxone||2211.44|577.22|
91599628|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.25|||||TWO_SIDED|90.0|64.5|247.11||||||Naloxone||247.11|64.50|
91599629|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.53|||||TWO_SIDED|90.0|38.79|163.06||||||Naloxone||163.06|38.79|
91599630|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|213.86|||||TWO_SIDED|90.0|107.07|427.17||||||Naloxone||427.17|107.07|
91599631|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|894.91|||||TWO_SIDED|90.0|436.49|1834.8||||||Naloxone||1834.80|436.49|
91599632|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.03|||||TWO_SIDED|90.0|85.94|143.44||||||Naloxone-3-β-D-Glucuronide||143.44|85.94|
91599633|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.22|||||TWO_SIDED|90.0|87.02|142.16||||||Naloxone-3-β-D-Glucuronide||142.16|87.02|
91599634|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.09|||||TWO_SIDED|90.0|64.32|107.35||||||Naloxone-3-β-D-Glucuronide||107.35|64.32|
91599635|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.66|||||TWO_SIDED|90.0|64.75|108.08||||||Naloxone-3-β-D-Glucuronide||108.08|64.75|
91599636|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.72|||||TWO_SIDED|90.0|100.93|174.53||||||Naloxone-3-β-D-Glucuronide||174.53|100.93|
91649835|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|95.0|-1050.39|1150.39||||||For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.||1150.39|-1050.39|
91649836|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-1850.65|1817.32||||||For change in constipation at EoS, mean change difference was used to compare the two treatment groups.||1817.32|-1850.65|
91709430|NCT03951753|183311464|OTHER||Least Squares Mean Difference|-245.5|||<|0.001|TWO_SIDED|95.0|-357.7|-133.3|||Mixed Models Analysis|||||-133.3|-357.7|<0.001
91599637|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.95|||||TWO_SIDED|90.0|102.12|173.1||||||Naloxone-3-β-D-Glucuronide||173.10|102.12|
91599638|NCT01846455|183090953|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.33|||||TWO_SIDED|90.0|75.54|130.61||||||Naloxone-3-β-D-Glucuronide||130.61|75.54|
91599639|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|125.19|||||TWO_SIDED|90.0|79.46|197.24||||||Buprenorphine||197.24|79.46|
91599640|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|220.97|||||TWO_SIDED|90.0|135.33|360.81||||||Buprenorphine||360.81|135.33|
91599641|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|249.28|||||TWO_SIDED|90.0|162.19|383.14||||||Buprenorphine||383.14|162.19|
91599642|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|94.44|||||TWO_SIDED|90.0|56.44|158.02||||||Buprenorphine||158.02|56.44|
91599643|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.57|||||TWO_SIDED|90.0|78.86|222.84||||||Buprenorphine||222.84|78.86|
91599644|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|233.99|||||TWO_SIDED|90.0|135.63|403.68||||||Buprenorphine||403.68|135.63|
91599645|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|263.97|||||TWO_SIDED|90.0|155.52|448.03||||||Buprenorphine||448.03|155.52|
91599646|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|159.38|||||TWO_SIDED|90.0|78.21|324.79||||||Norbuprenorphine||324.79|78.21|
91599647|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.93|||||TWO_SIDED|90.0|52.47|217.91||||||Norbuprenorphine||217.91|52.47|
91599648|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.1|||||TWO_SIDED|90.0|42.74|177.5||||||Norbuprenorphine||177.50|42.74|
91599649|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|182.98|||||TWO_SIDED|90.0|89.79|372.89||||||Norbuprenorphine||372.89|89.79|
91599650|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|122.77|||||TWO_SIDED|90.0|60.24|250.19||||||Norbuprenorphine||250.19|60.24|
91599651|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|69.12|||||TWO_SIDED|90.0|33.45|142.82||||||Naloxone||142.82|33.45|
91599652|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|282.17|||||TWO_SIDED|90.0|141.59|562.3||||||Naloxone||562.30|141.59|
91599653|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1497.7|||||TWO_SIDED|90.0|724.85|3094.59||||||Naloxone||3094.59|724.85|
91599654|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.64|||||TWO_SIDED|90.0|40.3|190.59||||||Naloxone||190.59|40.30|
91599655|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.86|||||TWO_SIDED|90.0|34.34|181.12||||||Naloxone||181.12|34.34|
91599656|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|321.94|||||TWO_SIDED|90.0|144.65|716.52||||||Naloxone||716.52|144.65|
91599657|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1708.83|||||TWO_SIDED|90.0|744.08|3924.47||||||Naloxone||3924.47|744.08|
91599658|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.2|||||TWO_SIDED|90.0|60.92|116.38||||||Naloxone-3-β-D-Glucuronide||116.38|60.92|
91599659|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|110.98|||||TWO_SIDED|90.0|82.02|150.17||||||Naloxone-3-β-D-Glucuronide||150.17|82.02|
91599660|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|81.97|||||TWO_SIDED|90.0|60.03|111.92||||||Naloxone-3-β-D-Glucuronide||111.92|60.03|
91599661|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|82.78|||||TWO_SIDED|90.0|59.89|114.42||||||Naloxone-3-β-D-Glucuronide||114.42|59.89|
91599662|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.71|||||TWO_SIDED|90.0|74.96|138.0||||||Naloxone-3-β-D-Glucuronide||138.00|74.96|
91599663|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|134.06|||||TWO_SIDED|90.0|101.07|177.82||||||Naloxone-3-β-D-Glucuronide||177.82|101.07|
91599664|NCT01846455|183090954|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.02|||||TWO_SIDED|90.0|73.93|132.61||||||Naloxone-3-β-D-Glucuronide||132.61|73.93|
91599665|NCT01449708|183090962|SUPERIORITY_OR_OTHER||Relative Risk|1.27||||0.04|TWO_SIDED|95.0|1.01|1.61|||Chi-squared|||||1.61|1.01|0.04
91599666|NCT01449708|183090964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04||||0.009|TWO_SIDED|95.0|1.28|7.29|||Chi-squared|||Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)||7.29|1.28|0.009
91649837|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
91649838|NCT00219557|183192175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-383.46|350.13||||||For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.||350.13|-383.46|
91649839|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|95.0|-10.11|15.29||||||For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.29|-10.11|
91649840|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||||TWO_SIDED|95.0|-13.39|20.2||||||For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.20|-13.39|
91709431|NCT03951753|183311464|OTHER||Least Squares Mean Difference|-309.8|||<|0.001|TWO_SIDED|95.0|-423.0|-196.6|||Mixed Models Analysis|||||-196.6|-423.0|<0.001
91709432|NCT03951753|183311464|OTHER||Least Squares Mean Difference|-64.3||||0.187|TWO_SIDED|95.0|-160.3|31.7|||Mixed Models Analysis|||||31.7|-160.3|0.187
91790465|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.231||0.753|TWO_SIDED|95.0|-0.381|0.526||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.526|-0.381|0.753
91599667|NCT01087541|183090993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5|<|0.01||95.0|0.0|1.0|||t-test, 2 sided|||||1|0|<0.01
91599668|NCT01087541|183090995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|5.0|<|0.001|TWO_SIDED|95.0|2.0|15.0|||t-test, 2 sided|||||15|2|<0.001
91784937|NCT01523275|183450093|EQUIVALENCE|Analysis of 44 subjects (22 in each arm) would provide 90% power to detect a difference in the time interval to reoperation of 6 months between the two treatment arms, at an alpha level of 0.05. This difference of 6 months is clinically meaningful and is smaller than previous case series studies would suggest. However, due to poor patient accrual, the study was closed prior to reaching the desired study size.||||||0.95|||||||t-test, 2 sided|||||||0.95
91784938|NCT01523275|183450094|EQUIVALENCE|A difference of 6 months to symptom progression is clinically meaningful.||||||0.52|||||||t-test, 2 sided|||||||0.52
91784939|NCT01523275|183450095|EQUIVALENCE|0.5 liters per second is clinically significant.||||||0.64|||||||t-test, 2 sided|||||||0.64
91784940|NCT00966875|183450218|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||A log transformed dose was used in the model.|Regression, Logistic|||||||0.031
91784941|NCT00966875|183450219|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Fisher Exact|||||||0.033
91784942|NCT00966875|183450219|SUPERIORITY_OR_OTHER|||||||0.047|||||||Fisher Exact|||||||0.047
91784943|NCT00966875|183450223|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
91784944|NCT00966875|183450223|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
91599669|NCT01340209|183090998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.048||0.7971|TWO_SIDED|95.0|-0.082|0.106|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.106|-0.082|0.7971
91599670|NCT01340209|183090998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.048||0.0203|TWO_SIDED|95.0|0.018|0.207|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.207|0.018|0.0203
91784945|NCT00966875|183450223|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91599671|NCT01340209|183090999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4944|TWO_SIDED|95.0|-0.141|0.068|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.068|-0.141|0.4944
91599672|NCT01340209|183090999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.054||0.127|TWO_SIDED|95.0|-0.023|0.188|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.188|-0.023|0.1270
91784946|NCT00966875|183450223|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784947|NCT00966875|183450223|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784948|NCT00966875|183450223|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784949|NCT00966875|183450223|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784950|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.227
91599673|NCT01340209|183091000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.498|STANDARD_ERROR_OF_MEAN|12.282||0.9677|TWO_SIDED|95.0|-23.634|24.63|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||24.630|-23.634|0.9677
91599674|NCT01340209|183091000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|34.176|STANDARD_ERROR_OF_MEAN|12.346||0.0058|TWO_SIDED|95.0|9.919|58.432|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium Respimat 5 μg minus placebo||58.432|9.919|0.0058
91599675|NCT01340209|183091001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.646|STANDARD_ERROR_OF_MEAN|9.182||0.3468|TWO_SIDED|95.0|-9.388|26.68|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||26.680|-9.388|0.3468
91784951|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.306
91784952|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.001
91784953|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.070
91784954|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.058
91784955|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.033
91784956|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.047
91784957|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.191
91784958|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.019
91784959|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.013
91784960|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.017
91784961|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.026
91784962|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.039
91784963|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.102
91784964|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.388|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.388
91784965|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.033
91649841|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|||||TWO_SIDED|95.0|5.96|33.43||||||For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||33.43|5.96|
91649842|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.7|||||TWO_SIDED|95.0|0.93|24.47||||||For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.47|0.93|
91649843|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|||||TWO_SIDED|95.0|1.28|28.91||||||For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||28.91|1.28|
91649844|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|||||TWO_SIDED|95.0|-14.59|23.3||||||For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||23.30|-14.59|
91649845|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-37.53|-4.85||||||For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||-4.85|-37.53|
91649846|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.82|||||TWO_SIDED|95.0|-25.04|9.4||||||For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||9.40|-25.04|
91649847|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.95|||||TWO_SIDED|95.0|-9.59|21.5||||||For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-9.59|
91649848|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.39|||||TWO_SIDED|95.0|-1.61|30.4||||||For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||30.40|-1.61|
91649849|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||||TWO_SIDED|95.0|2.78|22.22||||||For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.22|2.78|
91649850|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|1.36|20.39||||||For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.39|1.36|
91649851|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|||||TWO_SIDED|95.0|-16.36|11.71||||||For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||11.71|-16.36|
91649852|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.21|||||TWO_SIDED|95.0|-11.78|24.2||||||For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.20|-11.78|
91649853|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.87|||||TWO_SIDED|95.0|0.79|28.94||||||For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||28.94|0.79|
91522561|NCT00118716|182920183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1|STANDARD_ERROR_OF_MEAN|4.83||0.097|TWO_SIDED|95.0|-1.5|17.6||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for AM PEF||17.6|-1.5|0.097
91649854|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.49|||||TWO_SIDED|95.0|-7.45|34.42||||||For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||34.42|-7.45|
91649855|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.86|||||TWO_SIDED|95.0|0.17|37.55||||||For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||37.55|0.17|
91649856|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.57|||||TWO_SIDED|95.0|0.66|22.48||||||For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.48|0.66|
91649857|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.72|||||TWO_SIDED|95.0|0.49|36.95||||||For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.95|0.49|
91649858|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|||||TWO_SIDED|95.0|-32.4|11.17||||||For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||11.17|-32.40|
91649859|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-14.63|17.27||||||For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.27|-14.63|
91649860|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|||||TWO_SIDED|95.0|-14.7|17.78||||||For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.78|-14.70|
91649861|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.05|||||TWO_SIDED|95.0|-10.65|32.75||||||For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||32.75|-10.65|
91649862|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-17.33|24.13||||||For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||24.13|-17.33|
91649863|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.27|||||TWO_SIDED|95.0|-4.4|22.93||||||For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.93|-4.40|
91649864|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.19|||||TWO_SIDED|95.0|2.99|35.39||||||For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||35.39|2.99|
91649865|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-23.7|22.43||||||For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.43|-23.70|
91649866|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|||||TWO_SIDED|95.0|-3.1|46.12||||||For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||46.12|-3.10|
91649867|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-21.57|13.19||||||For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.19|-21.57|
91784966|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
91784967|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.199
91599676|NCT01340209|183091001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.216|STANDARD_ERROR_OF_MEAN|9.238||0.5013||95.0|-11.927|24.359|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||24.359|-11.927|0.5013
91784968|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
91784969|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.696|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.696
91784970|NCT00966875|183450225|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.112
91784971|NCT00966875|183450227|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
91784972|NCT00966875|183450227|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
91784973|NCT00966875|183450227|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
91784974|NCT00966875|183450227|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784975|NCT00966875|183450227|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784976|NCT00966875|183450227|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
91784977|NCT00966875|183450227|SUPERIORITY_OR_OTHER|||||||0.007||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.007
91599677|NCT01340209|183091002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.458|STANDARD_ERROR_OF_MEAN|9.196||0.2132|TWO_SIDED|95.0|-6.601|29.517|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||29.517|-6.601|0.2132
91599678|NCT01340209|183091002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.398|STANDARD_ERROR_OF_MEAN|9.245||0.0766|TWO_SIDED|95.0|-1.759|34.555|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||34.555|-1.759|0.0766
91599679|NCT01340209|183091003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.601|STANDARD_ERROR_OF_MEAN|1.038||0.5629|TWO_SIDED|95.0|-2.637|1.436|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||1.436|-2.637|0.5629
91599680|NCT01340209|183091003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|1.038||0.5871|TWO_SIDED|95.0|-1.473|2.601|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||2.601|-1.473|0.5871
91599681|NCT04781816|183091041|SUPERIORITY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.53|||TWO_SIDED|90.0|-18.26|6.85||||||Analysis was performed using mixed model with repeated measurements (MMRM) including fixed effects for baseline CLASI-A, post-baseline visit, geographical region, disease subtype, baseline use of CQ/HCQ, intervention group, visit-by- intervention group interaction, and visit-by-baseline-CLASI-A interaction.||6.85|-18.26|
91599682|NCT01789970|183091060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.26|1.0||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in WPI were compared between the active drug and placebo treatment groups.||1.00|0.26|<0.001
91599683|NCT01789970|183091061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED|95.0|0.25|0.91||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in API were compared between the active drug and placebo treatment groups.||0.91|0.25|<0.001
91599684|NCT01789970|183091062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.059|TWO_SIDED|95.0|0.5|1.01||5% significance level|Wald chi-square|Cox proportional hazards model with treatment, baseline worst pain intensity (WPI), opioid status, and center in the model||||1.01|0.5|0.059
91599685|NCT01789970|183091063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0293|TWO_SIDED|95.0|0.47|0.96||5% significance level|Regression, Logistic|stratified by center with the following effects: treatment group, baseline API, and opioid status.|Hydrocodone ER / Placebo|API increase \>=30% and API \>=5||0.96|0.47|0.0293
91784978|NCT00966875|183450229|SUPERIORITY_OR_OTHER|||||||0.093||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.093
91784979|NCT00966875|183450229|SUPERIORITY_OR_OTHER|||||||0.023||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.023
91784980|NCT00966875|183450229|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
91784981|NCT00966875|183450229|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
91784982|NCT00966875|183450229|SUPERIORITY_OR_OTHER|||||||0.028||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.028
91599686|NCT01789970|183091064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.557|TWO_SIDED|95.0|-1.2|0.65||5% significance level|ANCOVA|Model with the following effects: treatment, study center, opioid status, and baseline RMDQ score.|Placebo - Hydrocodone ER|||0.65|-1.20|0.557
91599687|NCT00662792|183091086|SUPERIORITY||Difference of adjusted means|0.13|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.102|0.158|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period.|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-12||0.158|0.102|<0.0001
91599688|NCT00662792|183091086|SUPERIORITY||Difference of adjusted means|0.07|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.042|0.097|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs Tiotropium (Tio18GEL) for FEV1 AUC0- 12||0.097|0.042|<.0001
91599689|NCT00662792|183091086|OTHER||Difference of adjusted means|-0.024|STANDARD_ERROR_OF_MEAN|0.014||0.0914|TWO_SIDED|95.0|-0.052|0.004|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.004|-0.052|0.0914
91784983|NCT00966875|183450229|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784984|NCT00966875|183450229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91784985|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.247||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.247
91784986|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.315||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.315
91784987|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
91784988|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
91599690|NCT00662792|183091087|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-Inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) for FEV1AUC12-24||0.093|0.036|<.0001
91599691|NCT00662792|183091087|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of FEV1AUC12-24||0.093|0.036|<.0001
91649868|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||||TWO_SIDED|95.0|-32.86|7.66||||||For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.66|-32.86|
91784989|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.055||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.055
91784990|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.365||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.365
91784991|NCT00966875|183450231|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.005
91784992|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.778||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.778
91784993|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.865||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.865
91784994|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.030
91784995|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.331||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.331
91784996|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.039||||||P-value is for Week 12..|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.039
91784997|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.292||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.292
91784998|NCT00966875|183450233|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.003
91784999|NCT00966875|183450235|SUPERIORITY_OR_OTHER|||||||0.09||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.090
91599692|NCT00662792|183091087|OTHER||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.015||0.0001|TWO_SIDED|95.0|-0.086|-0.028|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.028|-0.086|0.0001
91599693|NCT00662792|183091088|SUPERIORITY||Difference of adjusted means|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.102|0.166|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of Peak FEV1||0.166|0.102|<.0001
91599694|NCT00662792|183091088|SUPERIORITY||Difference of adjusted means|0.066|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.034|0.098|||ANOVA|Analysis of with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of PeakFEV1.||0.098|0.034|<.0001
91599695|NCT00662792|183091088|OTHER||Difference of adjusted means|-0.026|STANDARD_ERROR_OF_MEAN|0.016||0.1093|TWO_SIDED|95.0|-0.058|0.006|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S\_DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.006|-0.058|0.1093
91599696|NCT00662792|183091089|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Differences of adjusted means|0.058|STANDARD_ERROR_OF_MEAN|0.017||0.0008|TWO_SIDED|95.0|0.024|0.092|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of trough FEV1||0.092|0.024|0.0008
91599697|NCT00662792|183091089|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as a delta of 0.050 L.|Difference of adjusted means|0.029|STANDARD_ERROR_OF_MEAN|0.017||0.0857|TWO_SIDED|95.0|-0.004|0.063|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of trough FEV1||0.063|-0.004|0.0857
91599698|NCT00662792|183091089|OTHER||Difference of adjusted means|-0.037|STANDARD_ERROR_OF_MEAN|0.017||0.0317|TWO_SIDED|95.0|-0.071|-0.003|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.003|-0.071|0.0317
91599699|NCT00662792|183091090|SUPERIORITY||Difference of adjusted means|0.097|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.071|0.124|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-24||0.124|0.071|<.0001
91599700|NCT00662792|183091090|SUPERIORITY||Difference of adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.041|0.093|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) for FEV1 AUC24||0.093|0.041|<.0001
91599701|NCT00662792|183091090|SUPERIORITY||Difference of adjusted means|-0.041|STANDARD_ERROR_OF_MEAN|0.014||0.0029|TWO_SIDED|95.0|-0.067|-0.014|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (T18GEL+S-DPI)|||-0.014|-0.067|0.0029
91599702|NCT00662792|183091091|SUPERIORITY||Difference of adjusted means|0.083|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|0.034|0.132|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|||0.132|0.034|0.0010
91522562|NCT00118716|182920184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.396|TWO_SIDED|95.0|-4.8|12.1||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID PM PEF.||12.1|-4.8|0.396
91599703|NCT00662792|183091091|SUPERIORITY||Difference of adjusted means|0.176|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.127|0.226|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.226|0.127|<.0001
91599704|NCT00662792|183091091|SUPERIORITY||Difference of adjusted means|-0.045|STANDARD_ERROR_OF_MEAN|0.025||0.0757|TWO_SIDED|95.0|-0.095|0.005|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.005|-0.095|0.0757
91599705|NCT00662792|183091092|SUPERIORITY||Difference of adjusted means|0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.033|0.137|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.137|0.033|0.0015
91599706|NCT00662792|183091092|SUPERIORITY||Difference of adjusted means|0.118|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.066|0.171|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.171|0.066|<.0001
91599707|NCT00662792|183091092|SUPERIORITY||Difference of adjusted means|-0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0017|TWO_SIDED|95.0|-0.138|-0.032|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.032|-0.138|0.0017
91599708|NCT00662792|183091093|SUPERIORITY||Difference of adjusted means|0.084|STANDARD_ERROR_OF_MEAN|0.024||0.0005|TWO_SIDED|95.0|0.037|0.131|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.131|0.037|0.0005
91599709|NCT00662792|183091093|SUPERIORITY||Difference of adjusted means|0.147|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.194|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.194|0.100|<.0001
91599710|NCT00662792|183091093|SUPERIORITY||Difference of adjusted means|-0.065|STANDARD_ERROR_OF_MEAN|0.024||0.0074|TWO_SIDED|95.0|-0.113|-0.018|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.018|-0.113|0.0074
91522563|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.168|TWO_SIDED|95.0|-0.08|0.43||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 2||0.43|-0.08|0.168
91599711|NCT00662792|183091094|SUPERIORITY||Differences of adjusted means|0.051|STANDARD_ERROR_OF_MEAN|0.03||0.0898|TWO_SIDED|95.0|-0.008|0.109|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.109|-0.008|0.0898
91599712|NCT00662792|183091094|SUPERIORITY||Difference of adjusted means|0.142|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.083|0.201|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.201|0.083|<.0001
91785000|NCT00966875|183450235|SUPERIORITY_OR_OTHER|||||||0.131||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.131
91522564|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.147||0.465|TWO_SIDED|95.0|-0.18|0.4||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 4.||0.40|-0.18|0.465
91522565|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.133||0.222|TWO_SIDED|95.0|-0.1|0.42||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Endpoint.||0.42|-0.10|0.222
91522566|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.294|TWO_SIDED|95.0|-0.29|0.09||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 2.||0.09|-0.29|0.294
91522567|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.111||0.828|TWO_SIDED|95.0|-0.24|0.19||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 4.||0.19|-0.24|0.828
91522568|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.903|TWO_SIDED|95.0|-0.19|0.22||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Endpoint.||0.22|-0.19|0.903
91522569|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.112||0.464|TWO_SIDED|95.0|-0.3|0.14|||ANCOVA|LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 2.||0.14|-0.30|0.464
91522570|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.551|TWO_SIDED|95.0|-0.32|0.17||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 4.||0.17|-0.32|0.551
91522571|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.633|TWO_SIDED|95.0|-0.3|0.18||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Endpoint.||0.18|-0.30|0.633
91522572|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.094||0.7|TWO_SIDED|95.0|-0.22|0.15||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 2.||0.15|-0.22|0.700
91599713|NCT00662792|183091094|SUPERIORITY||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.03||0.0601|TWO_SIDED|95.0|-0.116|0.002|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.002|-0.116|0.0601
91599714|NCT00662792|183091095|SUPERIORITY||Difference of adjusted means|-0.028|STANDARD_ERROR_OF_MEAN|0.031||0.3652|TWO_SIDED|95.0|-0.089|0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.033|-0.089|0.3652
91785001|NCT00966875|183450235|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
91785002|NCT00966875|183450235|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
91785003|NCT00966875|183450235|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
91599715|NCT00662792|183091095|SUPERIORITY||Difference of adjusted means|0.042|STANDARD_ERROR_OF_MEAN|0.031||0.1816|TWO_SIDED|95.0|-0.02|0.103|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.103|-0.020|0.1816
91599716|NCT00662792|183091095|SUPERIORITY||Difference of adjusted means|-0.095|STANDARD_ERROR_OF_MEAN|0.031||0.0026|TWO_SIDED|95.0|-0.157|-0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.033|-0.157|0.0026
91599717|NCT00662792|183091096|SUPERIORITY||Difference of adjusted means|11.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|6.9|16.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||16.8|6.9|<.0001
91785004|NCT00966875|183450235|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91785005|NCT00966875|183450235|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91785006|NCT00966875|183450237|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91785007|NCT00966875|183450237|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.012
91785008|NCT00966875|183450237|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91599718|NCT00662792|183091096|SUPERIORITY||Difference of adjusted means|24.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|19.2|29.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||29.2|19.2|<.0001
91785009|NCT00966875|183450237|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91599719|NCT00662792|183091096|SUPERIORITY||Difference of adjusted means|-3.4|STANDARD_ERROR_OF_MEAN|2.6||0.1804|TWO_SIDED|95.0|-8.5|1.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||1.6|-8.5|0.1804
91599720|NCT00662792|183091097|SUPERIORITY||Difference of adjusted means|8.5|STANDARD_ERROR_OF_MEAN|2.5||0.0008|TWO_SIDED|95.0|3.5|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|3.5|0.0008
91599721|NCT00662792|183091097|SUPERIORITY||Difference of adjusted means|10.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|5.6|15.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||15.5|5.6|<.0001
91599722|NCT00662792|183091097|SUPERIORITY||Difference of adjusted means|-12.9|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-17.9|-8.0|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-8.0|-17.9|<.0001
91599723|NCT00662792|183091098|SUPERIORITY||Difference of adjusted means|10.1|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|5.7|14.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||14.6|5.7|<.0001
91599724|NCT00662792|183091098|SUPERIORITY||Difference of adjusted means|17.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|12.9|21.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||21.9|12.9|<.0001
91599725|NCT00662792|183091098|SUPERIORITY||Difference of adjusted means|-8.2|STANDARD_ERROR_OF_MEAN|2.3||0.0004|TWO_SIDED|95.0|-12.7|-3.7|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-3.7|-12.7|0.0004
91599726|NCT00662792|183091099|SUPERIORITY||Difference of adjusted means|13.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|7.2|18.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||18.9|7.2|<.0001
91599727|NCT00662792|183091099|SUPERIORITY||Difference of adjusted means|23.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|17.2|28.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||28.9|17.2|<.0001
91599728|NCT00662792|183091099|SUPERIORITY||Difference in adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|3.0||0.0769|TWO_SIDED|95.0|-11.2|0.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.6|-11.2|0.0769
91599729|NCT00662792|183091100|SUPERIORITY||Difference of adjusted means|2.8|STANDARD_ERROR_OF_MEAN|3.2||0.3775|TWO_SIDED|95.0|-3.5|9.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||9.1|-3.5|0.3775
91599730|NCT00662792|183091100|SUPERIORITY||Difference of adjusted means|7.1|STANDARD_ERROR_OF_MEAN|3.2||0.0285|TWO_SIDED|95.0|0.7|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|0.7|0.0285
91785010|NCT00966875|183450237|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91599731|NCT00662792|183091100|SUPERIORITY||Difference of adjusted means|-8.9|STANDARD_ERROR_OF_MEAN|3.2||0.0065|TWO_SIDED|95.0|-15.2|-2.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-2.5|-15.2|0.0065
91599732|NCT00662792|183091104|SUPERIORITY||Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|2.4||0.0182|TWO_SIDED|95.0|1.0|10.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning PEF||10.4|1.0|0.0182
91599733|NCT00662792|183091104|SUPERIORITY||Difference of adjusted means|6.3|STANDARD_ERROR_OF_MEAN|2.4||0.0091|TWO_SIDED|95.0|1.6|11.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning PEF||11.1|1.6|0.0091
91599734|NCT00662792|183091104|SUPERIORITY||Difference of adjusted means|-8.0|STANDARD_ERROR_OF_MEAN|2.4||0.001|TWO_SIDED|95.0|-12.8|-3.3|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning PEF||-3.3|-12.8|0.0010
91785011|NCT00966875|183450237|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
91785012|NCT00966875|183450237|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
91785013|NCT00966875|183450239|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.013
91649869|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.25|||||TWO_SIDED|95.0|-10.33|34.82||||||For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||34.82|-10.33|
91599735|NCT00662792|183091104|SUPERIORITY||Difference of adjusted means|11.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|5.8|16.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening PEF||16.2|5.8|<.0001
91599736|NCT00662792|183091104|SUPERIORITY||Difference of adjusted means|23.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|18.1|28.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening PEF||28.6|18.1|<.0001
91599737|NCT00662792|183091104|SUPERIORITY||Difference of adjusted means|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.5766|TWO_SIDED|95.0|-3.8|6.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening PEF||6.8|-3.8|0.5766
91599738|NCT00662792|183091105|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.016||0.0137|TWO_SIDED|95.0|0.008|0.071|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning FEV1||0.071|0.008|0.0137
91599739|NCT00662792|183091105|SUPERIORITY||Difference of adjusted means|0.027|STANDARD_ERROR_OF_MEAN|0.016||0.0981|TWO_SIDED|95.0|-0.005|0.059|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning FEV1||0.059|-0.005|0.0981
91599740|NCT00662792|183091105|SUPERIORITY||Difference of adjusted means|-0.022|STANDARD_ERROR_OF_MEAN|0.016||0.1827|TWO_SIDED|95.0|-0.054|0.01|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning FEV1||0.010|-0.054|0.1827
91599741|NCT00662792|183091105|SUPERIORITY||Difference of adjusted means|0.057|STANDARD_ERROR_OF_MEAN|0.018||0.0014|TWO_SIDED|95.0|0.022|0.092|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening FEV1||0.092|0.022|0.0014
91599742|NCT00662792|183091105|SUPERIORITY||Difference of adjusted means|0.105|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.07|0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening FEV1||0.140|0.070|<.0001
91599743|NCT00662792|183091105|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.018||0.2584|TWO_SIDED|95.0|-0.015|0.056|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening FEV1||0.056|-0.015|0.2584
91599744|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0027|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.02|-0.11|0.0027
91599745|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.4587|TWO_SIDED|95.0|-0.06|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||0.03|-0.06|0.4587
91599746|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1535|TWO_SIDED|95.0|-0.01|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.08|-0.01|0.1535
91599747|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0002|TWO_SIDED|95.0|-0.14|-0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.05|-0.14|0.0002
91599748|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0006|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||-0.04|-0.14|0.0006
91599749|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.5784|TWO_SIDED|95.0|-0.06|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.04|-0.06|0.5784
91599750|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|24 hours||-0.04|-0.14|0.0003
91599751|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED|95.0|-0.12|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|24 hours||-0.02|-0.12|0.0042
91599752|NCT00662792|183091106|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9978|TWO_SIDED|95.0|-0.05|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|24 hours||0.05|-0.05|0.9978
91599753|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0029|TWO_SIDED|95.0|-0.55|-0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.11|-0.55|0.0029
91599754|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0012|TWO_SIDED|95.0|-0.58|-0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||-0.14|-0.58|0.0012
91649870|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84|||||TWO_SIDED|95.0|-0.18|25.85||||||For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||25.85|-0.18|
91785014|NCT00966875|183450239|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.076
91649871|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|-16.45|24.14||||||For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.14|-16.45|
91785015|NCT00966875|183450239|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.002
91785016|NCT00966875|183450239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||<0.001
91649872|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05|||||TWO_SIDED|95.0|-23.23|37.34||||||For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||37.34|-23.23|
91649873|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|||||TWO_SIDED|95.0|-26.55|21.5||||||For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-26.55|
91649874|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|||||TWO_SIDED|95.0|-27.48|8.56||||||For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.56|-27.48|
91649875|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.96|||||TWO_SIDED|95.0|-30.62|16.7||||||For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.70|-30.62|
91649876|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||||TWO_SIDED|95.0|-20.37|27.8||||||For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-20.37|
91649877|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.04|||||TWO_SIDED|95.0|-5.73|31.81||||||For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||31.81|-5.73|
91649878|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12|||||TWO_SIDED|95.0|-3.23|33.46||||||For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.46|-3.23|
91649879|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||||TWO_SIDED|95.0|-36.18|20.37||||||For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||20.37|-36.18|
91649880|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||||TWO_SIDED|95.0|-20.24|51.01||||||For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||51.01|-20.24|
91599755|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0829|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.25|-0.02|0.0829
91599756|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0115|TWO_SIDED|95.0|-0.3|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.04|-0.30|0.0115
91649881|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.25|||||TWO_SIDED|95.0|-10.09|32.59||||||For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||32.59|-10.09|
91649882|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|||||TWO_SIDED|95.0|-25.22|40.03||||||For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||40.03|-25.22|
91599757|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1772|TWO_SIDED|95.0|-0.22|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||0.04|-0.22|0.1772
91599758|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6895|TWO_SIDED|95.0|-0.18|0.27|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.27|-0.18|0.6895
91599759|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.21|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Over 24 hours||-0.21|-0.84|0.0013
91649883|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.28|||||TWO_SIDED|95.0|4.23|52.32||||||For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||52.32|4.23|
91649884|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.22|||||TWO_SIDED|95.0|5.09|43.34||||||For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.34|5.09|
91649885|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||||TWO_SIDED|95.0|-0.16|50.38||||||For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||50.38|-0.16|
91649886|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07|||||TWO_SIDED|95.0|-47.95|27.8||||||For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-47.95|
91649887|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|||||TWO_SIDED|95.0|-21.78|14.57||||||For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||14.57|-21.78|
91649888|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.98|||||TWO_SIDED|95.0|-17.02|28.99||||||For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-17.02|
91649889|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.08|||||TWO_SIDED|95.0|-5.39|49.55||||||For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||49.55|-5.39|
91649890|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.78|||||TWO_SIDED|95.0|-15.33|34.89||||||For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||34.89|-15.33|
91649891|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.81|||||TWO_SIDED|95.0|-10.43|42.06||||||For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.06|-10.43|
91785017|NCT00966875|183450239|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.002
91785018|NCT00966875|183450239|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.006
91785019|NCT00966875|183450239|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.001
91785020|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.307||||||P-value is for Week 12.|ANCOVA|||||||0.307
91785021|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.104||||||P-value is for Week 12.|ANCOVA|||||||0.104
91785022|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.139||||||P-value is for Week 12.|ANCOVA|||||||0.139
91599760|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.78|-0.15|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Over 24 hours||-0.15|-0.78|0.0040
91599761|NCT00662792|183091107|SUPERIORITY||Difference of adjusted means|0.16|STANDARD_ERROR_OF_MEAN|0.16||0.3287|TWO_SIDED|95.0|-0.16|0.48|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Over 24 hours||0.48|-0.16|0.3287
91599762|NCT00662792|183091108|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9956|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.03|0.9956
91599763|NCT00662792|183091108|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.71|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7100
91599764|NCT00662792|183091108|SUPERIORITY||Difference of adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3659|TWO_SIDED|95.0|-0.02|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.04|-0.02|0.3659
91599765|NCT00662792|183091109|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4416|TWO_SIDED|95.0|-0.04|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.02|-0.04|0.4416
91599766|NCT00662792|183091109|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.7058|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7058
91599767|NCT00662792|183091109|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.1494|TWO_SIDED|95.0|-0.01|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.05|-0.01|0.1494
91599768|NCT00662792|183091110|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.998|TWO_SIDED|95.0|-0.06|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.06|-0.06|0.9980
91599769|NCT00662792|183091110|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4618|TWO_SIDED|95.0|-0.04|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.08|-0.04|0.4618
91599770|NCT00662792|183091110|SUPERIORITY||Difference of adjusted means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0418|TWO_SIDED|95.0|0.0|0.12|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.12|0.00|0.0418
91599771|NCT00662792|183091111|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4206|TWO_SIDED|95.0|-0.08|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.08|0.4206
91599772|NCT00662792|183091111|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.8723|TWO_SIDED|95.0|-0.05|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.06|-0.05|0.8723
91599773|NCT00662792|183091111|SUPERIORITY||Difference of adjusted means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1005|TWO_SIDED|95.0|-0.01|0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.11|-0.01|0.1005
91599774|NCT04311086|183091130|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
91599775|NCT04311086|183091131|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
91599776|NCT04311086|183091132|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment||||>0.05
91649892|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.77|||||TWO_SIDED|95.0|1.11|42.43||||||For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.43|1.11|
91649893|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|||||TWO_SIDED|95.0|-41.91|12.28||||||For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||12.28|-41.91|
91649894|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.11|||||TWO_SIDED|95.0|1.6|60.62||||||For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||60.62|1.60|
91649895|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|||||TWO_SIDED|95.0|-20.62|38.1||||||For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.10|-20.62|
91649896|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||||TWO_SIDED|95.0|-68.52|42.05||||||For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.05|-68.52|
91649897|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|||||TWO_SIDED|95.0|-7.93|52.05||||||For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||52.05|-7.93|
91649898|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.63|||||TWO_SIDED|95.0|-5.64|42.89||||||For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.89|-5.64|
91649899|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.96|||||TWO_SIDED|95.0|-9.93|57.84||||||For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||57.84|-9.93|
91649900|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.54|||||TWO_SIDED|95.0|-32.7|59.78||||||For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.78|-32.70|
91649901|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.14|||||TWO_SIDED|95.0|-29.46|55.74||||||For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||55.74|-29.46|
91649902|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.37|||||TWO_SIDED|95.0|-24.04|36.79||||||For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||36.79|-24.04|
91649903|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.59|||||TWO_SIDED|95.0|-17.94|59.12||||||For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.12|-17.94|
91522573|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.86|TWO_SIDED|95.0|-0.23|0.2||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 4.||0.20|-0.23|0.860
91649904|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29|||||TWO_SIDED|95.0|-20.12|40.71||||||For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||40.71|-20.12|
91649905|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.74|||||TWO_SIDED|95.0|-8.22|59.69||||||For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.69|-8.22|
91649906|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.56|||||TWO_SIDED|95.0|5.32|71.81||||||For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||71.81|5.32|
91649907|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-53.14|44.25||||||For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||44.25|-53.14|
91649908|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-69.9|61.57||||||For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||61.57|-69.90|
91649909|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-24.52|50.45||||||For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||50.45|-24.52|
91649910|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.15|||||TWO_SIDED|95.0|-76.41|30.11||||||For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.11|-76.41|
91649911|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.44|||||TWO_SIDED|95.0|-71.89|33.0||||||For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||33.00|-71.89|
91649912|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|7.31|87.13||||||For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||87.13|7.31|
91785023|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.056||||||P-value is for Week 12.|ANCOVA|||||||0.056
91785024|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|||||||0.048
91785025|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value is for Week 12.|ANCOVA|||||||0.160
91785026|NCT00966875|183450241|SUPERIORITY_OR_OTHER|||||||0.029||||||P-value is for Week 12.|ANCOVA|||||||0.029
91785027|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.272||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.272
91785028|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.962||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.962
91785029|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.236||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.236
91785030|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.316||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.316
91785031|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.138||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.138
91785032|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.975||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.975
91785033|NCT00966875|183450243|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.079
91599777|NCT04311086|183091133|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
91599778|NCT04311086|183091137|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||<0.05
91599779|NCT04311086|183091138|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||||||<0.05
91599780|NCT04311086|183091139|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
91599781|NCT04311086|183091140|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
91599782|NCT02499029|183091150|SUPERIORITY|||||||0.05|||||||Regression, Linear|||A series of hierarchical linear regression analyses were conducted to examine the effects of treatment group (NAC or placebo) on PTSD symptomatology, craving, substance use, and depression. Baseline levels of the respective outcome measures were entered in Step 1 of the model to adjust for any baseline differences. Treatment group was entered as the predictor in Step 2. The significance threshold was set at a p-value of .05 (two-sided) for all statistical tests.||||.05
91599783|NCT00756938|183091151|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.22||||0.753|TWO_SIDED|95.0|-6.45|8.9|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||8.90|-6.45|0.753
91599784|NCT00756938|183091152|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.81||||0.643|TWO_SIDED|95.0|-5.9|9.51|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||9.51|-5.90|0.643
91599785|NCT04823949|183091155|OTHER||Risk Ratio (RR)|1.59|||<|0.001|TWO_SIDED|95.0|1.33|1.88|||Chi-squared|||||1.88|1.33|<0.001
91599786|NCT04823949|183091156|OTHER||Risk Ratio (RR)|1.35||||0.53|TWO_SIDED|95.0|0.52|3.49|||Fisher Exact|||||3.49|0.52|.530
91599787|NCT04823949|183091157|OTHER||Risk Ratio (RR)|2.53||||0.059|TWO_SIDED|95.0|0.92|6.9|||Fisher Exact|||||6.90|0.92|.059
91599788|NCT04823949|183091158|OTHER||Risk Ratio (RR)|0.84||||0.792|TWO_SIDED|95.0|0.23|3.04|||Fisher Exact|||||3.04|0.23|.792
91599789|NCT04823949|183091159|OTHER||Risk Ratio (RR)|1.11||||0.21|TWO_SIDED|95.0|0.94|1.31|||Chi-squared|||||1.31|0.94|.210
91599790|NCT00441545|183091166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0|||||ANCOVA|||||||0.1130
91599791|NCT00441545|183091167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0249||95.0|||||ANCOVA|||||||0.0249
91599792|NCT02347176|183091170|SUPERIORITY||Adjusted Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.968||0.143|TWO_SIDED|95.0|-6.78|0.99|||Mixed Model Repeated Measures Analysis|||||0.99|-6.78|0.143
91599793|NCT02347176|183091170|SUPERIORITY||Adjusted Mean Difference|-4.36|STANDARD_ERROR_OF_MEAN|1.951||0.027|TWO_SIDED|95.0|-8.22|-0.51|||Mixed Model Repeated Measures Analysis|||||-0.51|-8.22|0.027
91599794|NCT02347176|183091170|SUPERIORITY||Adjusted Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.932||0.011|TWO_SIDED|95.0|-8.76|-1.13|||Mixed Model Repeated Measures Analysis|||||-1.13|-8.76|0.011
91599795|NCT02347176|183091171|SUPERIORITY||Odds Ratio (OR)|0.98||||0.974|TWO_SIDED|95.0|0.29|3.32|||Regression, Logistic|||||3.32|0.29|0.974
91599796|NCT02347176|183091171|SUPERIORITY||Odds Ratio (OR)|1.85||||0.281|TWO_SIDED|95.0|0.61|5.65|||Regression, Logistic|||||5.65|0.61|0.281
91599797|NCT02347176|183091171|SUPERIORITY||Odds Ratio (OR)|2.83||||0.061|TWO_SIDED|95.0|0.95|8.37|||Regression, Logistic|||||8.37|0.95|0.061
91599798|NCT00411554|183091184|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent|Least-squares Mean Difference|-0.39|||<|0.001||95.0|-0.51|-0.28||"This p-value corresponds to a test of superiority that was performed after success was achieved in the test of non-inferiority (reported under Estimation below), according to the pre-specified analysis plan"|ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show non-inferiority and superiority to voglibose (closed procedure) and to estimate difference of two groups and its 95% confidence interval|||-0.28|-0.51|<0.001
91599799|NCT00411554|183091185|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-10.7|||<|0.001||95.0|-15.3|-6.2|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-6.2|-15.3|<0.001
91599800|NCT00411554|183091186|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-18.8|||<|0.001||95.0|-26.7|-10.9|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-10.9|-26.7|<0.001
91649913|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.67|||||TWO_SIDED|95.0|-36.0|119.34||||||For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||119.34|-36.00|
91649914|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-5.05|82.83||||||For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||82.83|-5.05|
91710805|NCT02258217|183314018|EQUIVALENCE|"We created a difference in EDSS score variable. This was calculated as follows:~EDSS score (new relapse) - EDSS score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.23|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the median difference in EDSS scores is 0.0 to 0.5|"We compared the two EDSS scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post EDSS scores."||||0.23
91785034|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.982||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.982
91599801|NCT00143455|183091194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.236||||0.0556||95.0|0.995|1.536|||Cox Proportional Hazard Model|||A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.||1.536|0.995|0.0556
91649915|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.14|||||TWO_SIDED|95.0|-2.09|66.37||||||For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-2.09|
91649916|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-44.46|29.64||||||For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||29.64|-44.46|
91649917|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-40.45|66.37||||||For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-40.45|
91785035|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.276||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.276
91785036|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.050
91785037|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
91785038|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.046
91785039|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
91785040|NCT00966875|183450245|SUPERIORITY_OR_OTHER|||||||0.066||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.066
91785041|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.538||||||P-value is for Week 12.|Fisher Exact|||||||0.538
91785042|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.515||||||P-value is for Week 12.|Fisher Exact|||||||0.515
91785043|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|Fisher Exact|||||||0.030
91599802|NCT00143455|183091195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.343||||0.143||95.0|0.905|1.993|||Chi-squared|||||1.993|0.905|0.143
91599803|NCT00143455|183091196|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|Hazard Ratio (HR)|1.35||||0.011||95.0|1.071|1.701|||Cox Proportional Hazard Model|||||1.701|1.071|0.0110
91599804|NCT00143455|183091197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.354||||0.0831||95.0|0.961|1.908|||Cox Proportional Hazard Model|||||1.908|0.961|0.0831
91599805|NCT00143455|183091198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.965||||0.7544||95.0|0.771|1.208|||Cox Proportional Hazard Model|||||1.208|0.771|0.7544
91599806|NCT02682901|183091201|SUPERIORITY|||||||0.603||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.603
91599807|NCT02682901|183091202|SUPERIORITY|||||||0.068||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.068
91599808|NCT02682901|183091203|SUPERIORITY|||||||0.493||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.493
91599809|NCT02682901|183091204|SUPERIORITY|||||||0.524||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.524
91599810|NCT02682901|183091205|SUPERIORITY|||||||0.63||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.630
91599811|NCT02682901|183091206|SUPERIORITY|||||||0.537||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.537
91599812|NCT02682901|183091207|SUPERIORITY|||||||0.53||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.530
91599813|NCT02682901|183091208|SUPERIORITY|||||||0.005||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.005
91599814|NCT01639872|183091209|SUPERIORITY||difference in treatment means|0.014|STANDARD_ERROR_OF_MEAN|1.62||0.99|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.99
91599815|NCT01639872|183091210|SUPERIORITY||difference in treatment means|-0.32|STANDARD_ERROR_OF_MEAN|0.28||0.25|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.25
91599816|NCT03850912|183091211|SUPERIORITY||Odds Ratio (OR)|1.104||||0.214|TWO_SIDED|95.0|0.944|1.29|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (chemo and surgical patients combined)||1.290|0.944|0.214
91599817|NCT03850912|183091211|SUPERIORITY||Odds Ratio (OR)|0.927||||0.565|TWO_SIDED|95.0|0.715|1.201|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.201|0.715|0.565
91599818|NCT03850912|183091211|SUPERIORITY||Odds Ratio (OR)|1.225||||0.042|TWO_SIDED|95.0|1.008|1.49|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.490|1.008|0.042
91599819|NCT03850912|183091212|OTHER||Odds Ratio (OR)|1.128||||0.05|TWO_SIDED|95.0|1.0|1.272|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.272|1.000|0.050
91599820|NCT03850912|183091212|OTHER||Odds Ratio (OR)|1.012||||0.903|TWO_SIDED|95.0|0.836|1.225|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.225|0.836|0.903
91599821|NCT03850912|183091212|OTHER||Odds Ratio (OR)|1.215||||0.014|TWO_SIDED|95.0|1.04|1.418|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.418|1.040|0.014
91599822|NCT03850912|183091213|OTHER||Odds Ratio (OR)|1.002||||0.978|TWO_SIDED|95.0|0.881|1.139|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.139|0.881|0.978
91599823|NCT03850912|183091213|OTHER||Odds Ratio (OR)|0.854||||0.126|TWO_SIDED|95.0|0.697|1.046|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.046|0.697|0.126
91599824|NCT03850912|183091213|OTHER||Odds Ratio (OR)|1.102||||0.254|TWO_SIDED|95.0|0.933|1.302|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.302|0.933|0.254
91599825|NCT03850912|183091214|OTHER||Odds Ratio (OR)|1.068||||0.209|TWO_SIDED|95.0|0.964|1.183|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.183|0.964|0.209
91599826|NCT03850912|183091214|OTHER||Odds Ratio (OR)|0.992||||0.924|TWO_SIDED|95.0|0.85|1.159|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.159|0.850|0.924
91599827|NCT03850912|183091214|OTHER||Odds Ratio (OR)|1.122||||0.099|TWO_SIDED|95.0|0.979|1.286|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.286|0.979|0.099
91599828|NCT03850912|183091215|SUPERIORITY||Difference|-1.328||||0.04|TWO_SIDED|95.0|-2.593|-0.062|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||-0.062|-2.593|0.04
91599829|NCT03850912|183091215|OTHER||Difference|-1.958||||0.004|TWO_SIDED|95.0|-3.269|-0.646|||Regression, Logistic|||Multivariable regression analyses (surgical cohort only)||-0.646|-3.269|0.004
91599830|NCT03850912|183091216|SUPERIORITY||Difference|-0.925||||0.09|TWO_SIDED|95.0|-1.985|0.136|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.136|-1.985|0.09
91599831|NCT03850912|183091216|SUPERIORITY||Difference|-1.516||||0.002|TWO_SIDED|95.0|-2.474|-0.557|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-0.557|-2.474|0.002
91599832|NCT03850912|183091217|SUPERIORITY||Difference|-1.767||||0.17|TWO_SIDED|95.0|-2.532|0.433|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.433|-2.532|0.17
91599833|NCT03850912|183091217|SUPERIORITY||Difference|-2.198|||<|0.0001|TWO_SIDED|95.0|-3.259|-1.137|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-1.137|-3.259|<0.0001
91599834|NCT03850912|183091218|SUPERIORITY||Difference|-0.8084||||0.2|TWO_SIDED|95.0|-2.048|0.431|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.431|-2.048|0.2
91599835|NCT03850912|183091218|SUPERIORITY||Difference|-0.652||||0.27|TWO_SIDED|95.0|-1.8|0.496|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.496|-1.800|0.27
91599836|NCT03850912|183091219|SUPERIORITY||Difference|-0.617||||0.23|TWO_SIDED|95.0|-1.62|0.386|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.386|-1.620|0.23
91599837|NCT03850912|183091219|SUPERIORITY||Difference|0.434||||0.39|TWO_SIDED|95.0|-0.563|1.431|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||1.431|-0.563|0.39
91599838|NCT03850912|183091220|SUPERIORITY||Difference|-0.7||||0.22|TWO_SIDED|95.0|-1.829|0.429|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.429|-1.829|0.22
91599839|NCT03850912|183091220|SUPERIORITY||Difference|-0.58||||0.28|TWO_SIDED|95.0|-1.632|0.472|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.472|-1.632|0.28
91599840|NCT03850912|183091221|SUPERIORITY||Odds Ratio (OR)|0.842|||<|0.001|TWO_SIDED|95.0|0.776|0.913|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (chemo and surgical patients combined)||0.913|0.776|<0.001
91599841|NCT03850912|183091221|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.001|TWO_SIDED|95.0|0.688|0.885|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.885|0.688|<0.001
91599842|NCT03850912|183091221|SUPERIORITY||Odds Ratio (OR)|0.889||||0.032|TWO_SIDED|95.0|0.799|0.99|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.990|0.799|0.032
91599843|NCT03850912|183091222|SUPERIORITY||Odds Ratio (OR)|0.893|||<|0.001|TWO_SIDED|95.0|0.839|0.949|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.949|0.839|<0.001
91599844|NCT03850912|183091222|SUPERIORITY||Odds Ratio (OR)|0.872||||0.003|TWO_SIDED|95.0|0.796|0.954|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.954|0.796|0.003
91599845|NCT03850912|183091222|SUPERIORITY||Odds Ratio (OR)|0.909||||0.027|TWO_SIDED|95.0|0.835|0.989|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.989|0.835|0.027
91599846|NCT03850912|183091223|SUPERIORITY||Odds Ratio (OR)|0.636|||<|0.001|TWO_SIDED|95.0|0.593|0.682|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.682|0.593|<0.001
91599847|NCT03850912|183091223|SUPERIORITY||Odds Ratio (OR)|0.611|||<|0.001|TWO_SIDED|95.0|0.55|0.679|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.679|0.550|<0.001
91599848|NCT03850912|183091223|SUPERIORITY||Odds Ratio (OR)|0.655|||<|0.001|TWO_SIDED|95.0|0.597|0.719|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.719|0.597|<0.001
91599849|NCT03850912|183091224|SUPERIORITY||Odds Ratio (OR)|0.769|||<|0.001|TWO_SIDED|95.0|0.729|0.811|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.811|0.729|<0.001
91599850|NCT03850912|183091224|SUPERIORITY||Odds Ratio (OR)|0.795|||<|0.001|TWO_SIDED|95.0|0.737|0.858|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.858|0.737|<0.001
91599851|NCT03850912|183091224|SUPERIORITY||Odds Ratio (OR)|0.739|||<|0.001|TWO_SIDED|95.0|0.686|0.796|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.796|0.686|<0.001
91599852|NCT00720109|183091227|SUPERIORITY_OR_OTHER_LEGACY||Percentage|40.7|||<|0.001|TWO_SIDED|90.0|30.8|51.4|||Chi-squared|Chi-squared test equivalent to Z-test of proportions.||The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.||51.4|30.8|<0.001
91599853|NCT00720109|183091228|SUPERIORITY_OR_OTHER_LEGACY||percentage|10.5|||=|0.13|TWO_SIDED|90.0|5.3|19.3|||Binomial Test||The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.|||19.3|5.3|=0.13
91599854|NCT02177201|183091243|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: The antiemetic effect was not significantly different for two groups in this study||||0.05
91599855|NCT02177201|183091243|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared, Corrected|||77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.||||<0.05
91649918|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-32.71|60.49||||||For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||60.49|-32.71|
91599856|NCT05853380|183091244|OTHER|The primary outcome was considered successful if the bootstrapped upper 95% confidence interval on the RMSD was \< 3.0. Power was assessed by bootstrapping 95% confidence intervals at different n sizes on a product development population.|RMSD|0.77|||||TWO_SIDED|95.0|0.67|0.87||||||Subjects with simultaneously collected HR and PR comparator data were assigned to the comparison group.|The upper 95% confidence interval on the RMSD was 0.87, meeting the significance threshold of \< 3.0. The study tested hypothesis of accuracy \< 3.0 RMSD by showing the upper 95% confidence interval on the RMSD was \< 3.0. The upper 95% confidence interval on the RMSD was 0.87, meeting the target threshold of \< 3.0.|0.87|0.67|
91599857|NCT02926950|183091290|SUPERIORITY||Difference in Least Squares (LS) Means|-0.47|STANDARD_ERROR_OF_MEAN|0.084|<|0.0001|TWO_SIDED|95.0|-0.64|-0.309|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.309|-0.64|< 0.0001
91599858|NCT02926950|183091291|SUPERIORITY||Difference in LS Means|-1.572|STANDARD_ERROR_OF_MEAN|0.2457|<|0.0001|TWO_SIDED|95.0|-2.0538|-1.0909|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline 2- hour postprandial glucose as a covariate.||-1.0909|-2.0538|< 0.0001
91599859|NCT02926950|183091292|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.2247|=|0.0007|TWO_SIDED|95.0|-1.2006|-0.3198|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.3198|-1.2006|= 0.0007
91599860|NCT02926950|183091293|SUPERIORITY||Difference in LS Means|-1.87|STANDARD_ERROR_OF_MEAN|0.369|<|0.0001|TWO_SIDED|95.0|-2.591|-1.144|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline weight as a covariate.||-1.144|-2.591|< 0.0001
91599861|NCT02926950|183091294|SUPERIORITY||Difference in LS Means|-3.28|STANDARD_ERROR_OF_MEAN|1.422|=|0.0209|TWO_SIDED|95.0|-6.07|-0.497|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.497|-6.07|= 0.0209
91599862|NCT02926950|183091295|SUPERIORITY||Difference in LS Means|-3.54|STANDARD_ERROR_OF_MEAN|0.992|=|0.0004|TWO_SIDED|95.0|-5.479|-1.592|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.592|-5.479|= 0.0004
91599863|NCT02926950|183091296|SUPERIORITY||Percentage Difference|5.4|||=|0.0238|TWO_SIDED|95.0|0.75|10.06|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||10.06|0.75|= 0.0238
91599864|NCT02926950|183091297|SUPERIORITY||Percentage Difference|13.9|||=|0.0001|TWO_SIDED|95.0|6.91|20.89|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||20.89|6.91|= 0.0001
91599865|NCT03266016|183091303|SUPERIORITY||Odds Ratio (OR)|1.67||||0.045|TWO_SIDED|95.0|1.01|2.77|||Proportional Odds Logistic Regression|||This analysis is comparing length of weaning between REDvent acute group and control acute group.||2.77|1.01|.045
91599866|NCT03266016|183091303|SUPERIORITY||Proportional odds logistic regression|1.3|||||TWO_SIDED|95.0|0.7|2.6||||||Weaning Phase||2.6|0.7|
91599867|NCT03266016|183091304|SUPERIORITY||Incident rate ratio|1.03|||||TWO_SIDED|95.0|0.84|1.25|||||Negative binomial model.|||1.25|0.84|
91599868|NCT03266016|183091305|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.7||||||||2.7|0.4|
91599869|NCT03266016|183091306|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.44|2.47||||||||2.47|0.44|
91599870|NCT03266016|183091307|SUPERIORITY||Proportional odds logistic regression|1.6|||||TWO_SIDED|95.0|1.01|2.55||||||||2.55|1.01|
91599871|NCT01664793|183091326|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.||||||<0.05
91599872|NCT02787850|183091330|OTHER||sucess proportion|86.8|||||TWO_SIDED|95.0|71.9|95.6||||||||95.6|71.9|
91649919|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.86|||||TWO_SIDED|95.0|-16.16|77.89||||||For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.89|-16.16|
91649920|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-44.95|86.62||||||For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||86.62|-44.95|
91649921|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-115.22|78.19||||||For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||78.19|-115.22|
91649922|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.46|||||TWO_SIDED|95.0|-39.71|86.63||||||For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.63|-39.71|
91649923|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-130.69|104.76||||||For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||104.76|-130.69|
91599873|NCT02787850|183091330|OTHER||success proportion|76.7|||||TWO_SIDED|95.0|57.7|90.1||||||||90.1|57.7|
91649924|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.15|||||TWO_SIDED|95.0|-7.12|103.42||||||For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.42|-7.12|
91649925|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.59|||||TWO_SIDED|95.0|63.16|122.02||||||For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||122.02|63.16|
91649926|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-85.03|96.14||||||For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.14|-85.03|
91649927|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.04|||||TWO_SIDED|95.0|-29.46|103.54||||||For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.54|-29.46|
91649928|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.14|||||TWO_SIDED|95.0|-41.45|27.16||||||For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||27.16|-41.45|
91649929|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-67.04|59.64||||||For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||59.64|-67.04|
91649930|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-104.79|89.97||||||For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||89.97|-104.79|
91785044|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for Week 12.|Fisher Exact|||||||0.053
91599874|NCT02787850|183091330|OTHER||success proportion|87.7|||||TWO_SIDED|95.0|76.3|94.9||||||||94.9|76.3|
91599875|NCT02787850|183091330|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|66.3|95.8||||||||95.8|66.3|
91599876|NCT02944448|183091348|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7093|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|||||0.5|-0.4|0.7093
91599877|NCT02944448|183091349|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.6007|TWO_SIDED|95.0|-13.1|7.6|||Mixed Models Analysis|||||7.6|-13.1|0.6007
91599878|NCT02944448|183091350|SUPERIORITY||Median Difference (Final Values)|-0.8||||0.4563|TWO_SIDED|95.0|-3.0|1.4|||Mixed Models Analysis|||||1.4|-3.0|0.4563
91649931|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-58.8|103.25||||||For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.25|-58.80|
91649932|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-36.28|91.83||||||For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||91.83|-36.28|
91649933|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-74.3|96.52||||||For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.52|-74.30|
91649934|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.17|||||TWO_SIDED|95.0|-142.55|84.21||||||For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||84.21|-142.55|
91649935|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.56|||||TWO_SIDED|95.0|-212.46|101.35||||||For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||101.35|-212.46|
91599879|NCT02944448|183091351|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8693|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||||0.8|-1.0|0.8693
91599880|NCT02944448|183091352|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.6516|TWO_SIDED|95.0|-9.1|5.7|||Mixed Models Analysis|||||5.7|-9.1|0.6516
91649936|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-62.93|96.26||||||For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-62.93|
91649937|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-87.74|116.31||||||For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||116.31|-87.74|
91649938|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.81|||||TWO_SIDED|95.0|7.9|139.72||||||For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||139.72|7.90|
91649939|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|33.64|118.74||||||For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||118.74|33.64|
91649940|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-64.64|121.79||||||For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||121.79|-64.64|
91649941|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.71|||||TWO_SIDED|95.0|-28.11|99.53||||||For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||99.53|-28.11|
91649942|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.33|||||TWO_SIDED|95.0|-104.01|77.34||||||For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.34|-104.01|
91649943|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.44|||||TWO_SIDED|95.0|-140.03|51.14||||||For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||51.14|-140.03|
91785045|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.393||||||P-value is for Week 12.|Fisher Exact|||||||0.393
91785046|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.077||||||P-value is for Week 12.|Fisher Exact|||||||0.077
91785047|NCT00966875|183450247|SUPERIORITY_OR_OTHER|||||||0.105||||||P-value is for Week 12.|Fisher Exact|||||||0.105
91785048|NCT00689117|183450255|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.063
91785049|NCT00689117|183450255|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.003
91785050|NCT00689117|183450255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
91785051|NCT00689117|183450255|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.004
91599881|NCT02944448|183091353|SUPERIORITY||Odds Ratio (OR)|0.7||||0.1033|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.1|0.5|0.1033
91599882|NCT02944448|183091354|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2831|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.2|0.5|0.2831
91599883|NCT02944448|183091355|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1959|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Logistic regression with treatment as a main effect and OA joint as a covariate.|"Ratio between treatment odds of having a PGIC of Very Much Improved or Much Improved."|||2.0|0.9|0.1959
91599884|NCT02944448|183091356|SUPERIORITY|||||||0.2858|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test stratified by Primary OA joint (Hip or Knee) and Baseline Week Mean of the Daily NRS (\<6.7 or \>=6.7) (Van Elteren test).||||||0.2858
91599885|NCT02944448|183091357|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8002|TWO_SIDED|95.0|0.3|2.7|||Regression, Logistic|Logistic regression, including treatment, baseline pain score, and OA joint as independent variables.|Ratio between treatment odds of withdrawing from treatment due to lack of analgesic efficacy.|||2.7|0.3|0.8002
91599886|NCT02397473|183091377|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|1.63||0.036|TWO_SIDED|95.0|-6.72|-0.23|||Mixed Models Analysis|||||-0.23|-6.72|0.036
91599887|NCT02397473|183091378|SUPERIORITY|||||||0.046|||||||ANCOVA|Koch's nonparametric randomization-based ANCOVA.||||||0.046
91599888|NCT02397473|183091379|SUPERIORITY||LSMean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.2||0.493|TWO_SIDED|95.0|-3.23|1.57|||Mixed Models Analysis|||||1.57|-3.23|0.493
91599889|NCT02397473|183091380|SUPERIORITY||Odds Ratio (OR)|3.046||||0.016|TWO_SIDED|95.0|1.242|7.469|||Mixed Models Analysis|||||7.469|1.242|0.016
91599890|NCT02397473|183091381|SUPERIORITY||Odds Ratio (OR)|1.312||||0.575|TWO_SIDED|95.0|0.502|3.426|||Mixed Models Analysis|||||3.426|.502|0.575
91599891|NCT02397473|183091382|SUPERIORITY||Odds Ratio (OR)|0.965||||0.91|TWO_SIDED|95.0|0.512|1.819|||Mixed Models Analysis|Pseudo-likelihood-based repeated measures.||||1.819|.512|0.910
91599892|NCT02397473|183091383|SUPERIORITY||Odds Ratio (OR)|0.929||||0.841|TWO_SIDED|95.0|0.449|1.923|||Mixed Models Analysis|Pseudolikelihood-based repeated measures model||||1.923|0.449|0.841
91599893|NCT01415752|183091438|SUPERIORITY|||||||0.25||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.25
91599894|NCT01415752|183091439|SUPERIORITY|||||||0.178||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.178
91599895|NCT03083886|183091464|SUPERIORITY||Risk Ratio (RR)|0.93||||0.04|TWO_SIDED|95.0|0.87|0.997|||GEE with log link and Poisson errors|||||.997|.87|.04
91599896|NCT03083886|183091464|SUPERIORITY||Risk Ratio (RR)|1.4|||<|0.001|TWO_SIDED|95.0|1.35|1.45|||GEE with log link and Poisson errors|||||1.45|1.35|<0.001
91599897|NCT03083886|183091465|SUPERIORITY||Risk Difference (RD)|-5.8|||<|0.001|TWO_SIDED|95.0|-7.7|-3.9|||GEE with identity link and normal errors|||||-3.9|-7.7|<0.001
91599898|NCT03083886|183091465|SUPERIORITY||Risk Difference (RD)|-4.3|||<|0.001|TWO_SIDED|95.0|-5.9|-2.6|||GEE with identity link and normal errors|||||-2.6|-5.9|<0.001
91599899|NCT03083886|183091466|SUPERIORITY||Risk Difference (RD)|-7.5|||<|0.001|TWO_SIDED|95.0|-9.4|-5.7|||GEE with identity link and normal errors|||||-5.7|-9.4|<0.001
91599900|NCT03083886|183091466|SUPERIORITY||Risk Difference (RD)|-6.7|||<|0.001|TWO_SIDED|95.0|-8.4|-5.0|||GEE with identity link and normal errors|||||-5.0|-8.4|<0.001
91599901|NCT03083886|183091467|SUPERIORITY||Risk Difference (RD)|4.7|||<|0.001|TWO_SIDED|95.0|2.6|6.8|||GEE with identity link and normal errors|||||6.8|2.6|<0.001
91599902|NCT03083886|183091467|SUPERIORITY||Risk Difference (RD)|6.0|||<|0.001|TWO_SIDED|95.0|4.1|7.9|||GEE with identity link and normal errors|||||7.9|4.1|<0.001
91599903|NCT03083886|183091468|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.001|TWO_SIDED|95.0|5.0|8.7|||GEE with identity link and normal errors|||||8.7|5.0|<0.001
91599904|NCT03083886|183091468|SUPERIORITY||Risk Difference (RD)|6.7|||<|0.001|TWO_SIDED|95.0|5.0|8.4|||GEE with identity link and normal errors|||||8.4|5.0|<0.001
91599905|NCT03066102|183091513|OTHER|||||||0.227||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular elevation. Muscle fatigue would increase reposition error during scapular elevation. One-way repeated measures analysis of variance.||||0.227
91599906|NCT03066102|183091513|OTHER|||||||0.764||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular protraction. Muscle fatigue would increase reposition error during scapular protraction. One-way repeated measures analysis of variance.||||0.764
91599907|NCT03066102|183091514|OTHER|||||||0.413||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.413
91599908|NCT03066102|183091514|OTHER|||||||0.984||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.984
91599909|NCT03066102|183091514|OTHER|||||||0.006||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.006
91599910|NCT03066102|183091514|OTHER|||||||0.154||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.154
91599911|NCT03066102|183091514|OTHER|||||||0.096||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.096
91649944|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-88.45|97.98||||||For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||97.98|-88.45|
91599912|NCT03066102|183091514|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.037
91599913|NCT03066102|183091515|OTHER|||||||8.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of serratus anterior during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.000085
91599914|NCT03066102|183091515|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of upper trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.037
91599915|NCT03066102|183091515|OTHER|||||||0.382||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of lower trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.382
91599916|NCT03066102|183091516|OTHER|||||||0.000467||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular posterior tilt during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular posterior tilt during each angle of scaption.||||0.000467
91599917|NCT03066102|183091516|OTHER|||||||0.093||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.093
91599918|NCT03066102|183091516|OTHER|||||||0.062||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.062
91599919|NCT03066102|183091516|OTHER|||||||0.04||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.04
91599920|NCT03066102|183091516|OTHER|||||||0.000147||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000147
91599921|NCT03066102|183091516|OTHER|||||||1.2e-05||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000012
91599922|NCT03066102|183091516|OTHER|||||||0.007||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.007
91599923|NCT03066102|183091516|OTHER|||||||0.059||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.059
91599924|NCT03066102|183091516|OTHER|||||||0.032||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.032
91599925|NCT03066102|183091516|OTHER|||||||1.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular internal rotation during scaption Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular internal rotation during each angle of scaption.||||0.000015
91599926|NCT03066102|183091516|OTHER|||||||0.296||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.296
91599927|NCT03066102|183091516|OTHER|||||||0.457||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.457
91599928|NCT03066102|183091516|OTHER|||||||0.311||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.311
91785052|NCT00689117|183450255|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.550
91522574|NCT00118716|182920187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.919|TWO_SIDED|95.0|-0.19|0.21||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Endpoint.||0.21|-0.19|0.919
91785053|NCT00689117|183450255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
91785054|NCT00689117|183450255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
91785055|NCT00689117|183450255|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Total lesion count|Ranked ANCOVA|||||||0.016
91785056|NCT00689117|183450255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
91785057|NCT00689117|183450256|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||0.001
91785058|NCT00689117|183450256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
91599929|NCT03066102|183091516|OTHER|||||||0.004||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.004
91599930|NCT03066102|183091516|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
91599931|NCT03066102|183091516|OTHER|||||||0.137||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.137
91599932|NCT03066102|183091516|OTHER|||||||0.636||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.636
91599933|NCT03066102|183091516|OTHER|||||||0.406||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.406
91599934|NCT03066102|183091516|OTHER|||||||0.001||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular upward rotation during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular upward rotation during each angle of scaption.||||0.001
91599935|NCT03066102|183091516|OTHER|||||||0.65||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.650
91599936|NCT03066102|183091516|OTHER|||||||0.141||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.141
91599937|NCT03066102|183091516|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
91599938|NCT03066102|183091516|OTHER|||||||0.005||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.005
91599939|NCT03066102|183091516|OTHER|||||||0.083||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.083
91599940|NCT03066102|183091516|OTHER|||||||0.389||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.389
91599941|NCT03066102|183091516|OTHER|||||||0.542||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.542
91599942|NCT03066102|183091516|OTHER|||||||0.263||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.263
91599943|NCT03066102|183091517|OTHER|||||||0.331||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of upper trapezius during each angle of scaption."||||0.331
91599944|NCT03066102|183091517|OTHER|||||||0.627||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of lower trapezius during each angle of scaption."||||0.627
91599945|NCT03066102|183091517|OTHER|||||||0.042||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of serratus anterior during each angle of scaption."||||0.042
91599946|NCT03066102|183091517|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 30\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
91599947|NCT03066102|183091517|OTHER|||||||0.018||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 60\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.018
91599948|NCT03066102|183091517|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 90\~120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
91599949|NCT03066102|183091517|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 120\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
91785059|NCT00689117|183450256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
91599950|NCT03066102|183091517|OTHER|||||||0.035||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 90\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.035
91599951|NCT03066102|183091517|OTHER|||||||0.05||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 60\~30 degree of scaption.~One-way repeated measures analysis of variance."||||0.05
91599952|NCT03066102|183091518|OTHER|||||||0.5||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of upper trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.5
91599953|NCT03066102|183091518|OTHER|||||||0.843||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of lower trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.843
91599954|NCT03066102|183091518|OTHER|||||||0.466||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of serratus anterior during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.466
91599955|NCT01496066|183091522|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
91599956|NCT01496066|183091523|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
91599957|NCT01496066|183091524|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
91599958|NCT01496066|183091525|SUPERIORITY|||||||0.0318|||||||t-test, 2 sided|||||||.0318
91599959|NCT01496066|183091526|EQUIVALENCE|a two-group t-test of equivalence in means was used|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|99.0|-0.06|-0.02||||||||-0.02|-0.06|
91599960|NCT03237065|183091533|SUPERIORITY||Risk Difference (RD)|-65.8|||<|0.0001|TWO_SIDED|95.0|-76.6|-49.8|||Cochran-Mantel-Haenszel|Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.|Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-49.8|-76.6|<0.0001
91599961|NCT03237065|183091534|SUPERIORITY|||||||0.0511|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan- Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.0511
91599962|NCT03237065|183091535|SUPERIORITY||Risk Difference (RD)|-44.6|||<|0.0001|TWO_SIDED|95.0|-57.7|-31.6|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-31.6|-57.7|<0.0001
91785060|NCT00689117|183450257|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.065
91599963|NCT03237065|183091536|SUPERIORITY||Mean Difference (Final Values)|0.46|||<|0.0001|TWO_SIDED|95.0|0.3|0.62|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.62|0.30|<0.0001
91599964|NCT03237065|183091536|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.32|0.76|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.32|<0.0001
91599965|NCT03237065|183091536|SUPERIORITY||Mean Difference (Final Values)|0.73|||<|0.0001|TWO_SIDED|95.0|0.49|0.96|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.96|0.49|<0.0001
91649945|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-54.32|82.89||||||For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||82.89|-54.32|
91785061|NCT00689117|183450257|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.002
91785062|NCT00689117|183450257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
91785063|NCT00689117|183450257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
91599966|NCT03237065|183091536|SUPERIORITY||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.99|1.46|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.46|0.99|<0.0001
91599967|NCT03237065|183091536|SUPERIORITY||Mean Difference (Final Values)|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.51|0.98|<0.0001
91599968|NCT03237065|183091536|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.91|1.43|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.43|0.91|<0.0001
91599969|NCT03237065|183091537|SUPERIORITY||Mean Difference (Final Values)|13.99|||<|0.0001|TWO_SIDED|95.0|9.38|18.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||18.59|9.38|<0.0001
91599970|NCT03237065|183091537|SUPERIORITY||Mean Difference (Final Values)|15.84|||<|0.0001|TWO_SIDED|95.0|9.45|22.23|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.23|9.45|<0.0001
91599971|NCT03237065|183091537|SUPERIORITY||Mean Difference (Final Values)|21.66|||<|0.0001|TWO_SIDED|95.0|14.72|28.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.59|14.72|<0.0001
91599972|NCT03237065|183091537|SUPERIORITY||Mean Difference (Final Values)|36.17|||<|0.0001|TWO_SIDED|95.0|29.28|43.06|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.06|29.28|<0.0001
91599973|NCT03237065|183091537|SUPERIORITY||Mean Difference (Final Values)|37.86|||<|0.0001|TWO_SIDED|95.0|29.99|45.72|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.72|29.99|<0.0001
91649946|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-66.45|114.07||||||For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||114.07|-66.45|
91649947|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.75|||||TWO_SIDED|95.0|-56.14|119.63||||||For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||119.63|-56.14|
91649948|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.0|||||TWO_SIDED|95.0|-163.35|63.35||||||For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||63.35|-163.35|
91649949|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-125.23|96.66||||||For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.66|-125.23|
91649950|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
91785064|NCT00689117|183450257|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.284
91785065|NCT00689117|183450257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
91785066|NCT00689117|183450257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
91785067|NCT00689117|183450257|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||Total lesion count|Ranked ANCOVA|||||||0.028
91785068|NCT00689117|183450257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
91785069|NCT00689117|183450258|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Cochran-Mantel-Haenszel|||||||0.671
91522575|NCT00855062|182920190|SUPERIORITY_OR_OTHER||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.248||0.37|TWO_SIDED|95.0|-0.512|0.46||The p-value was not adjusted for multiple comparisons.|Regression, Linear|||"The null hypothesis was that the 24-week changes of U NP Sum between the minocycline and placebo groups are the same.~The sample size calculation showed that 100 (50 participants in each group) were required to detect the clinically meaningful difference of 0.5 with 85% power, 0.05 Type I error, two-sample and two-sided test."||0.460|-0.512|0.370
91599974|NCT03237065|183091537|SUPERIORITY||Mean Difference (Final Values)|34.53|||<|0.0001|TWO_SIDED|95.0|26.8|42.26|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||42.26|26.80|<0.0001
91599975|NCT03237065|183091539|SUPERIORITY||Mean Difference (Final Values)|-96.8|||<|0.0001|TWO_SIDED|95.0|-119.8|-73.8|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-73.8|-119.8|<0.0001
91599976|NCT03237065|183091539|SUPERIORITY||Mean Difference (Final Values)|-15.7||||0.1064|TWO_SIDED|95.0|-34.9|3.4|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.4|-34.9|0.1064
91599977|NCT03237065|183091539|SUPERIORITY||Mean Difference (Final Values)|-251.7|||<|0.0001|TWO_SIDED|95.0|-307.2|-196.2|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-196.2|-307.2|<0.0001
91599978|NCT03237065|183091539|SUPERIORITY||Mean Difference (Final Values)|-79.1|||<|0.0001|TWO_SIDED|95.0|-103.7|-54.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.5|-103.7|<0.0001
91599979|NCT03237065|183091539|SUPERIORITY||Mean Difference (Final Values)|-61.8|||<|0.0001|TWO_SIDED|95.0|-83.0|-40.5|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.5|-83.0|<0.0001
91785070|NCT00689117|183450258|SUPERIORITY_OR_OTHER|||||||0.919||95.0|||||Cochran-Mantel-Haenszel|||||||0.919
91785071|NCT00689117|183450258|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
91785072|NCT00689117|183450259|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
91785073|NCT00689117|183450259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91785074|NCT00689117|183450259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91785075|NCT02204124|183450260|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91785076|NCT02204124|183450261|SUPERIORITY|||||||0.513|||||||Chi-squared|||||||0.513
91785077|NCT02204124|183450264|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91785078|NCT02204124|183450265|SUPERIORITY|||||||0.132|||||||Chi-squared|||||||0.132
91785079|NCT02204124|183450266|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #1 is for readmission||||0.975
91785080|NCT02204124|183450266|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #2 is for wound infection.||||0.401
91785081|NCT02204124|183450266|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #3 is for gastroparesis.||||0.975
91785082|NCT02204124|183450266|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #4 is for pancreatic fistula.||||0.401
91785083|NCT02204124|183450266|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #5 is for intraabdominal abscess.||||0.219
91785084|NCT02204124|183450266|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #6 is for anastomotic leakage.||||0.401
91785085|NCT02204124|183450266|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #7 is for blood product transfusion (anemia).||||0.219
91785086|NCT01305577|183450296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.73|||<|0.001|TWO_SIDED|95.0|2.7|8.28|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.28|2.70|<0.001
91785087|NCT01305577|183450296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21|||<|0.001|TWO_SIDED|95.0|3.52|10.94|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.||10.94|3.52|<0.001
91785088|NCT01305577|183450297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58||||0.028|TWO_SIDED|95.0|1.2|25.87|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||25.87|1.20|0.028
91599980|NCT03237065|183091539|SUPERIORITY||Mean Difference (Final Values)|-18.0||||0.0039|TWO_SIDED|95.0|-30.1|-5.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.9|-30.1|0.0039
91599981|NCT03237065|183091540|SUPERIORITY||Mean Difference (Final Values)|-57.5||||0.1243|TWO_SIDED|95.0|-131.1|16.1|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.1|-131.1|0.1243
91599982|NCT03237065|183091540|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.5547|TWO_SIDED|95.0|-49.7|91.0|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||91.0|-49.7|0.5547
91599983|NCT03237065|183091540|SUPERIORITY||Mean Difference (Final Values)|-155.7||||0.0005|TWO_SIDED|95.0|-234.7|-76.6|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-76.6|-234.7|0.0005
91599984|NCT03237065|183091540|SUPERIORITY||Mean Difference (Final Values)|-27.3||||0.3516|TWO_SIDED|95.0|-86.0|31.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||31.5|-86.0|0.3516
91599985|NCT03237065|183091540|SUPERIORITY||Mean Difference (Final Values)|-24.3||||0.1988|TWO_SIDED|95.0|-62.3|13.7|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.7|-62.3|0.1988
91599986|NCT03237065|183091540|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.4379|TWO_SIDED|95.0|-18.6|41.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.2|-18.6|0.4379
91599987|NCT03237065|183091541|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.6869|TWO_SIDED|95.0|-1.06|0.7|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.70|-1.06|0.6869
91599988|NCT03237065|183091541|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.1037|TWO_SIDED|95.0|-2.29|0.22|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.22|-2.29|0.1037
91649951|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
91649952|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|14.55|141.0||||||For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||141.00|14.55|
91649953|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.11|||||TWO_SIDED|95.0|40.61|131.61||||||For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||131.61|40.61|
91649954|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-56.48|106.48||||||For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||106.48|-56.48|
91649955|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|-37.69|132.13||||||For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||132.13|-37.69|
91649956|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-70.68|110.68||||||For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.68|-70.68|
91649957|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-91.87|25.2||||||For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||25.20|-91.87|
91649958|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-41.89|97.45||||||For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||97.45|-41.89|
91649959|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-34.03|67.36||||||For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||67.36|-34.03|
91599989|NCT03237065|183091541|SUPERIORITY||Mean Difference (Final Values)|-1.62||||0.0213|TWO_SIDED|95.0|-2.99|-0.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.25|-2.99|0.0213
91599990|NCT03237065|183091541|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.0176|TWO_SIDED|95.0|-3.47|-0.34|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.34|-3.47|0.0176
91599991|NCT03237065|183091541|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.0999|TWO_SIDED|95.0|-3.01|0.27|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.27|-3.01|0.0999
91599992|NCT03237065|183091541|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.8878|TWO_SIDED|95.0|-1.77|2.04|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-1.77|0.8878
91599993|NCT03237065|183091542|SUPERIORITY||Mean Difference (Final Values)|21.81|||<|0.0001|TWO_SIDED|95.0|17.66|25.95|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||25.95|17.66|<0.0001
91599994|NCT03237065|183091542|SUPERIORITY||Mean Difference (Final Values)|4.64||||0.2923|TWO_SIDED|95.0|-4.05|13.33|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.33|-4.05|0.2923
91599995|NCT03237065|183091542|SUPERIORITY||Mean Difference (Final Values)|19.56|||<|0.0001|TWO_SIDED|95.0|12.37|26.74|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||26.74|12.37|<0.0001
91649960|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-100.19|116.86||||||For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||116.86|-100.19|
91649961|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.93|||||TWO_SIDED|95.0|-53.73|105.58||||||For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||105.58|-53.73|
91649962|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-117.07|117.07||||||For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||117.07|-117.07|
91649963|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-221.53|249.31||||||For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||249.31|-221.53|
91649964|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-260.62|271.74||||||For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||271.74|-260.62|
91785089|NCT01305577|183450297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.05|||<|0.001|TWO_SIDED|95.0|2.75|52.9|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||52.90|2.75|<0.001
91599996|NCT03237065|183091542|SUPERIORITY||Mean Difference (Final Values)|33.05|||<|0.0001|TWO_SIDED|95.0|25.96|40.14|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||40.14|25.96|<0.0001
91599997|NCT03237065|183091542|SUPERIORITY||Mean Difference (Final Values)|21.82|||<|0.0001|TWO_SIDED|95.0|14.2|29.43|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.43|14.20|<0.0001
91599998|NCT03237065|183091542|SUPERIORITY||Mean Difference (Final Values)|9.03||||0.025|TWO_SIDED|95.0|1.16|16.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.90|1.16|0.0250
91599999|NCT03237065|183091543|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.5134|TWO_SIDED|95.0|-0.22|0.11|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.11|-0.22|0.5134
91600000|NCT03237065|183091543|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7579|TWO_SIDED|95.0|-0.24|0.32|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.32|-0.24|0.7579
91600001|NCT03237065|183091543|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3169|TWO_SIDED|95.0|-0.41|0.14|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|-0.41|0.3169
91600002|NCT03237065|183091543|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.0018|TWO_SIDED|95.0|-0.76|-0.18|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.18|-0.76|0.0018
91600003|NCT03237065|183091543|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0003|TWO_SIDED|95.0|-0.77|-0.24|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.24|-0.77|0.0003
91600004|NCT03237065|183091543|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1063|TWO_SIDED|95.0|-0.5|0.05|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.50|0.1063
91600005|NCT03237065|183091544|SUPERIORITY||Mean Difference (Final Values)|4.57||||0.2166|TWO_SIDED|95.0|-2.72|11.85|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.85|-2.72|0.2166
91785090|NCT01305577|183450298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.001|TWO_SIDED|95.0|1.74|5.14|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.14|1.74|<0.001
91790466|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91649965|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-152.41|285.75||||||For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||285.75|-152.41|
91649966|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|||||TWO_SIDED|95.0|-119.08|319.08||||||For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.08|-119.08|
91649967|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-185.75|252.41||||||For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||252.41|-185.75|
91649968|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-82.04|170.93||||||For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||170.93|-82.04|
91649969|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
91649970|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-202.34|180.12||||||For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||180.12|-202.34|
91649971|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
91785091|NCT01305577|183450298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.99|9.11|||Regression, Logistic|Logistic regression analysis with treatment and baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.11|2.99|<0.001
91785092|NCT01305577|183450299|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.35|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.35|-0.68|<0.001
91649972|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
91785093|NCT01305577|183450299|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.50|-0.84|<0.001
91649973|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-87.6|165.37||||||For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.37|-87.60|
91649974|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
91649975|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||||TWO_SIDED|95.0|-275.19|230.75||||||For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||230.75|-275.19|
91649976|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.33|||||TWO_SIDED|95.0|-491.86|608.53||||||For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.||608.53|-491.86|
91785094|NCT01305577|183450300|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.47|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.47|0.61|<0.001
91785095|NCT01305577|183450300|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|0.99|1.84|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.84|0.99|<0.001
91649977|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
91649978|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
91649979|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-175.06|191.73||||||For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.||191.73|-175.06|
91649980|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in ascites at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
91649981|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
91649982|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
91649983|NCT00219557|183192176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.56|||||TWO_SIDED|95.0|-1375.5|1436.61||||||For change in side effects at EoS, mean change difference was used to compare the two treatment groups.||1436.61|-1375.5|
91649984|NCT03063632|183192179|OTHER|||||||||||||||||Per Global Response Score used in Mycosis Fungoides and Sezary Syndrome, Response is assessed by the standard response criteria: Complete Response (CR), complete disappearance of all clinical evidence of disease where all categories (i.e., skin, lymph nodes, viscera, blood) have complete response/noninvolved; Partial Response (PR), regression of measurable disease; Stable Disease (SD), failure to attain CR, PR, or PD.|Simple statistics. Non-responders excluded from analysis.|||
91649985|NCT03063632|183192180|OTHER||||||||||||||||||Kaplan-Meier method|||
91600006|NCT03237065|183091544|SUPERIORITY||Mean Difference (Final Values)|-4.64||||0.2997|TWO_SIDED|95.0|-13.47|4.19|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.19|-13.47|0.2997
91600007|NCT03237065|183091544|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.9221|TWO_SIDED|95.0|-7.75|8.56|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||8.56|-7.75|0.9221
91600008|NCT03237065|183091544|SUPERIORITY||Mean Difference (Final Values)|-15.69||||0.0034|TWO_SIDED|95.0|-26.07|-5.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.32|-26.07|0.0034
91600009|NCT03237065|183091544|SUPERIORITY||Mean Difference (Final Values)|-22.54||||0.0002|TWO_SIDED|95.0|-33.93|-11.16|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-11.16|-33.93|0.0002
91600010|NCT03237065|183091544|SUPERIORITY||Mean Difference (Final Values)|-24.81|||<|0.0001|TWO_SIDED|95.0|-35.42|-14.21|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-14.21|-35.42|<0.0001
91600011|NCT03237065|183091545|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.3048|TWO_SIDED|95.0|-0.1|0.03|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.03|-0.10|0.3048
91600012|NCT03237065|183091545|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1641|TWO_SIDED|95.0|-0.02|0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.13|-0.02|0.1641
91600013|NCT03237065|183091545|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1333|TWO_SIDED|95.0|-0.02|0.12|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.02|0.1333
91600014|NCT03237065|183091545|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.9385|TWO_SIDED|95.0|-0.17|0.16|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.16|-0.17|0.9385
91600015|NCT03237065|183091545|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0408|TWO_SIDED|95.0|0.0|0.14|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|0.00|0.0408
91600016|NCT03237065|183091545|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.2376|TWO_SIDED|95.0|-0.03|0.12|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.03|0.2376
91600017|NCT03237065|183091547|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.0882|TWO_SIDED|95.0|-0.67|0.05|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.67|0.0882
91600018|NCT03237065|183091547|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0941|TWO_SIDED|95.0|-0.74|0.06|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.06|-0.74|0.0941
91600019|NCT03237065|183091547|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.0628|TWO_SIDED|95.0|-0.02|0.66|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.66|-0.02|0.0628
91600020|NCT03237065|183091547|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.0056|TWO_SIDED|95.0|0.14|0.79|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.79|0.14|0.0056
91600021|NCT03237065|183091547|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.0492|TWO_SIDED|95.0|0.0|0.55|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.55|0.00|0.0492
91600022|NCT03237065|183091547|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0882|TWO_SIDED|95.0|-0.05|0.64|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.64|-0.05|0.0882
91785096|NCT01305577|183450301|SUPERIORITY_OR_OTHER||LS mean Difference|-1.68|||<|0.001|TWO_SIDED|95.0|-2.5|-0.87|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.87|-2.50|<0.001
91785097|NCT01305577|183450301|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-2.79|-1.15|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline values as covariate.||||-1.15|-2.79|<0.001
91785098|NCT01305577|183450302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
91785099|NCT01305577|183450302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
91785100|NCT01256190|183450337|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91785101|NCT01256190|183450338|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
91785102|NCT01256190|183450339|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||intent-to-treat analysis||||.022
91785103|NCT01256190|183450340|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Fisher Exact|||intent-to treat analysis||||0.113
91785104|NCT01256190|183450341|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||intent-to-treat analysis||||.025
91600023|NCT03237065|183091548|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.6568|TWO_SIDED|95.0|-35.3|22.3|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.3|-35.3|0.6568
91600024|NCT03237065|183091548|SUPERIORITY||Mean Difference (Final Values)|-24.2||||0.4929|TWO_SIDED|95.0|-94.0|45.5|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.5|-94.0|0.4929
91600025|NCT03237065|183091548|SUPERIORITY||Mean Difference (Final Values)|-91.7||||0.0113|TWO_SIDED|95.0|-162.3|-21.1|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-21.1|-162.3|0.0113
91600026|NCT03237065|183091548|SUPERIORITY||Mean Difference (Final Values)|-240.4|||<|0.0001|TWO_SIDED|95.0|-318.4|-162.3|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-162.3|-318.4|<0.0001
91600027|NCT03237065|183091548|SUPERIORITY||Mean Difference (Final Values)|-135.1|||<|0.0001|TWO_SIDED|95.0|-196.1|-74.0|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-74.0|-196.1|<0.0001
91600028|NCT03237065|183091548|SUPERIORITY||Mean Difference (Final Values)|-67.7||||0.0039|TWO_SIDED|95.0|-113.2|-22.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-22.2|-113.2|0.0039
91600029|NCT03237065|183091549|SUPERIORITY||Mean Difference (Final Values)|24.2||||0.0503|TWO_SIDED|95.0|0.0|48.5|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||48.5|-0.0|0.0503
91600030|NCT03237065|183091549|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.5794|TWO_SIDED|95.0|-5.5|9.8|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.8|-5.5|0.5794
91600031|NCT03237065|183091549|SUPERIORITY||Mean Difference (Final Values)|-62.2|||<|0.0001|TWO_SIDED|95.0|-70.1|-54.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.3|-70.1|<0.0001
91600032|NCT03237065|183091549|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0001|TWO_SIDED|95.0|-10.4|-3.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-3.5|-10.4|0.0001
91600033|NCT03237065|183091549|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0008|TWO_SIDED|95.0|-9.1|-2.4|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-2.4|-9.1|0.0008
91600034|NCT03237065|183091549|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.004|TWO_SIDED|95.0|-8.1|-1.6|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.6|-8.1|0.0040
91600035|NCT03237065|183091550|SUPERIORITY||Risk Difference (RD)|-10.7||||0.009|TWO_SIDED|95.0|-18.8|-2.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-2.6|-18.8|0.0090
91600036|NCT02475655|183091635|SUPERIORITY|||||||0.67||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.||||0.67
91649986|NCT03063632|183192181|OTHER|||||||||||||||||Progression is assessed by the standard response criteria used in Mycosis Fungoides and Sezary Syndrome (skin, lymph nodes, viscera, blood, global). Per Global Response Score, progression is defined as Progressive Disease (PD) in any category (i.e., skin, lymph nodes, viscera, blood).|Kaplan-Meier method|||
91600037|NCT02475655|183091638|SUPERIORITY||Mean Difference (Net)|0.85||||0.18|TWO_SIDED|90.0|0.69|1.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.||1.04|0.69|0.18
91600038|NCT02475655|183091640|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.||||0.40
91600039|NCT02475655|183091644|SUPERIORITY||Mean Difference (Net)|1.31||||0.7|TWO_SIDED|90.0|-4.27|6.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.||6.90|-4.27|0.70
91600040|NCT02475655|183091644|SUPERIORITY||Mean Difference (Net)|1.61||||0.69|TWO_SIDED|90.0|-5.06|8.29||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.||8.29|-5.06|0.69
91600041|NCT02475655|183091644|SUPERIORITY||Mean Difference (Net)|6.35||||0.09|TWO_SIDED|90.0|0.16|12.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.||12.5|0.16|0.09
91600042|NCT02475655|183091646|SUPERIORITY||Mean Difference (Net)|-0.02||||0.58|TWO_SIDED|90.0|-0.06|0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.||0.03|-0.06|0.58
91600043|NCT02475655|183091646|SUPERIORITY||Mean Difference (Net)|-0.01||||0.79|TWO_SIDED|90.0|-0.06|0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.||0.04|-0.06|0.79
91600044|NCT02475655|183091646|SUPERIORITY||Mean Difference (Net)|-0.07||||0.016|TWO_SIDED|90.0|-0.11|-0.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.||-0.02|-0.11|0.016
91600045|NCT02475655|183091648|SUPERIORITY||Mean Difference (Net)|-679.0||||0.018|TWO_SIDED|90.0|-1146.0|-212.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.||-212|-1146|0.018
91600046|NCT02475655|183091648|SUPERIORITY||Mean Difference (Net)|-651.0||||0.021|TWO_SIDED|90.0|-1110.0|-192.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.||-192|-1110|0.021
91600047|NCT02475655|183091648|SUPERIORITY||Mean Difference (Net)|33.6||||0.91|TWO_SIDED|90.0|-461.0|528.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.||528|-461|0.91
91600048|NCT02475655|183091650|SUPERIORITY||Mean Difference (Net)|-0.13||||0.45|TWO_SIDED|90.0|-0.42|0.15||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.||0.15|-0.42|0.45
91600049|NCT02475655|183091650|SUPERIORITY||Mean Difference (Net)|-0.55||||0.005|TWO_SIDED|90.0|-0.87|-0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.||-0.23|-0.87|0.005
91600050|NCT02475655|183091650|SUPERIORITY||Mean Difference (Net)|0.15||||0.75|TWO_SIDED|90.0|-0.65|0.95||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.||0.95|-0.65|0.75
91600051|NCT02475655|183091652|SUPERIORITY||Mean Difference (Net)|37754.0|||<|0.001|TWO_SIDED|90.0|19609.0|55898.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.||55898|19609|<0.001
91600052|NCT02475655|183091652|SUPERIORITY||Mean Difference (Net)|27832.0||||0.012|TWO_SIDED|90.0|9849.0|45815.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.||45815|9849|0.012
91600053|NCT02475655|183091652|SUPERIORITY||Mean Difference (Net)|5376.0||||0.52|TWO_SIDED|90.0|-8592.0|19344.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.||19344|-8592|0.52
91600054|NCT02475655|183091654|SUPERIORITY||Mean Difference (Net)|4.96||||0.05|TWO_SIDED|90.0|0.78|9.14||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.||9.14|0.78|0.05
91600055|NCT02475655|183091654|SUPERIORITY||Mean Difference (Net)|8.15|||<|0.001|TWO_SIDED|90.0|4.47|11.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.||11.8|4.47|<0.001
91600056|NCT02475655|183091654|SUPERIORITY||Mean Difference (Net)|3.95||||0.025|TWO_SIDED|90.0|1.08|6.81||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.||6.81|1.08|0.025
91785105|NCT02834793|183450342|SUPERIORITY||Median Difference (Net)|-19.3|||=|0.107|TWO_SIDED|95.0|-49.2|4.8||The p-value was based on a rank analysis of covariance (ANCOVA) with treatment, region, and age-group as factors, and prerandomization drop seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95 percent (%) confidence interval (CI) were based on the Hodges-Lehmann method.|||4.8|-49.2|= 0.107
91785106|NCT03255629|183450377|OTHER|||||||0.103|||||||McNemar|||||||0.103
91785107|NCT03255629|183450378|OTHER|||||||0.18|||||||McNemar|||||||0.180
91785108|NCT03255629|183450380|OTHER|||||||0.317|||||||McNemar|||||||0.317
91600057|NCT02475655|183091656|SUPERIORITY||Mean Difference (Net)|4.9||||0.02|TWO_SIDED|90.0|1.46|8.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.||8.33|1.46|0.020
91600058|NCT02475655|183091656|SUPERIORITY||Mean Difference (Net)|11.0||||0.004|TWO_SIDED|90.0|4.84|17.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.||17.1|4.84|0.004
91600059|NCT02475655|183091656|SUPERIORITY||Mean Difference (Net)|4.64||||0.043|TWO_SIDED|90.0|0.88|8.39||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.||8.39|0.88|0.043
91600060|NCT02475655|183091657|SUPERIORITY||Mean Difference (Net)|1.1||||0.56|TWO_SIDED|90.0|0.84|1.44||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.||1.44|0.84|0.56
91649987|NCT03063632|183192182|OTHER||||||||||||||||||Kaplan-Meier method|||
91785109|NCT03255629|183450381|OTHER|||||||0.008|||||||McNemar|||||||0.008
91785110|NCT03255629|183450382|OTHER|||||||0.083|||||||McNemar|||||||0.083
91785111|NCT03255629|183450383|OTHER|||||||0.025|||||||McNemar|||||||0.025
91785112|NCT03255629|183450385|OTHER|||||||0.049|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.049
91785113|NCT03255629|183450386|OTHER|||||||0.056|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.056
91785114|NCT03255629|183450387|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91785115|NCT03255629|183450388|OTHER|||||||0.059|||||||Mixed Models Analysis|||||||0.059
91785116|NCT03255629|183450389|OTHER|||||||0.195|||||||Mixed Models Analysis|||||||0.195
91785117|NCT03255629|183450390|OTHER|||||||0.043|||||||Mixed Models Analysis|||||||0.043
91785118|NCT03255629|183450391|OTHER|||||||0.659|||||||Mixed Models Analysis|||||||0.659
91600061|NCT02475655|183091657|SUPERIORITY||Mean Difference (Net)|1.37||||0.026|TWO_SIDED|90.0|1.09|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.||1.73|1.09|0.026
91600062|NCT02475655|183091658|SUPERIORITY||Mean Difference (Net)|0.89||||0.07|TWO_SIDED|90.0|0.8|0.99||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.||0.99|0.80|0.07
91600063|NCT02475655|183091658|SUPERIORITY||Mean Difference (Net)|0.95||||0.59|TWO_SIDED|90.0|0.8|1.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.||1.12|0.80|0.59
91600064|NCT02475655|183091658|SUPERIORITY||Mean Difference (Net)|1.06||||0.56|TWO_SIDED|90.0|0.9|1.24||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.||1.24|0.90|0.56
91600065|NCT02475655|183091659|SUPERIORITY||Mean Difference (Net)|142.1||||0.007|TWO_SIDED|90.0|57.6|227.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.||227|57.6|0.007
91600066|NCT02475655|183091659|SUPERIORITY||Mean Difference (Net)|74.3||||0.14|TWO_SIDED|90.0|-8.23|156.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.||156.7|-8.23|0.14
91600067|NCT02475655|183091659|SUPERIORITY||Mean Difference (Net)|-38.9||||0.54|TWO_SIDED|90.0|-143.0|65.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.||65.5|-143|0.54
91600068|NCT02475655|183091659|SUPERIORITY||Mean Difference (Net)|-112.0||||0.12|TWO_SIDED|90.0|-231.0|5.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.||5.90|-231|0.12
91600069|NCT02475655|183091661|SUPERIORITY||Risk Ratio (RR)|0.98||||0.94|TWO_SIDED|90.0|0.65|1.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.||1.49|0.65|0.94
91600070|NCT02475655|183091661|SUPERIORITY||Risk Ratio (RR)|0.74||||0.46|TWO_SIDED|90.0|0.37|1.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.||1.46|0.37|0.46
91600071|NCT02475655|183091661|SUPERIORITY||Risk Ratio (RR)|0.83||||0.59|TWO_SIDED|90.0|0.46|1.48||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.||1.48|0.46|0.59
91600072|NCT02475655|183091662|SUPERIORITY||Mean Difference (Net)|0.88||||0.11|TWO_SIDED|90.0|0.76|1.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 5.||1.01|0.76|0.11
91600073|NCT02475655|183091662|SUPERIORITY||Mean Difference (Net)|0.92||||0.71|TWO_SIDED|90.0|0.64|1.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 12.||1.33|0.64|0.71
91600074|NCT02475655|183091663|SUPERIORITY||Mean Difference (Net)|1.27||||0.3|TWO_SIDED|90.0|0.87|1.86||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 5.||1.86|0.87|0.30
91600075|NCT02475655|183091663|SUPERIORITY||Mean Difference (Net)|1.59||||0.46|TWO_SIDED|90.0|0.56|4.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 12.||4.49|0.56|0.46
91600076|NCT02475655|183091664|SUPERIORITY||Mean Difference (Net)|1.29||||0.24|TWO_SIDED|90.0|0.9|1.84||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 5.||1.84|0.90|0.24
91600077|NCT02475655|183091664|SUPERIORITY||Mean Difference (Net)|1.19||||0.46|TWO_SIDED|90.0|0.81|1.74||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 12.||1.74|0.81|0.46
91600078|NCT02475655|183091669|SUPERIORITY||Mean Difference (Net)|1.15||||0.56|TWO_SIDED|90.0|0.77|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 5.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|1.72|0.77|0.56
91600079|NCT02475655|183091669|SUPERIORITY||Mean Difference (Net)|0.97||||0.95|TWO_SIDED|90.0|0.47|2.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 12.||2.01|0.47|0.95
91600080|NCT02475655|183091670|SUPERIORITY||Mean Difference (Net)|1.34||||0.002|TWO_SIDED|90.0|1.15|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 5.||1.56|1.15|0.002
91600081|NCT02475655|183091670|SUPERIORITY||Mean Difference (Net)|1.07||||0.6|TWO_SIDED|90.0|0.86|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 12.||1.34|0.86|0.60
91600082|NCT02475655|183091671|SUPERIORITY||Mean Difference (Net)|0.94||||0.4|TWO_SIDED|90.0|0.82|1.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 5.||1.07|0.82|0.40
91600083|NCT02475655|183091671|SUPERIORITY||Mean Difference (Net)|1.03||||0.82|TWO_SIDED|90.0|0.83|1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 12.||1.27|0.83|0.82
91600084|NCT02475655|183091672|SUPERIORITY||Mean Difference (Net)|1.5||||0.028|TWO_SIDED|90.0|1.11|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 5.||2.02|1.11|0.028
91600085|NCT02475655|183091672|SUPERIORITY||Mean Difference (Net)|2.04||||0.21|TWO_SIDED|90.0|0.79|5.25||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 12.||5.25|0.79|0.21
91649988|NCT03063632|183192183|OTHER||||||||||||||||||Binomial distribution|||
91785119|NCT03255629|183450392|OTHER|||||||0.406|||||||Mixed Models Analysis|||||||0.406
91785120|NCT03255629|183450393|OTHER|||||||0.611|||||||Mixed Models Analysis|||||||0.611
91785121|NCT03255629|183450394|OTHER|||||||0.183|||||||Mixed Models Analysis|||||||0.183
91785122|NCT03255629|183450395|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||0.009
91785123|NCT03255629|183450396|OTHER|||||||0.789|||||||Mixed Models Analysis|||||||0.789
91785124|NCT03255629|183450397|OTHER|||||||0.865|||||||McNemar|||||||0.865
91649989|NCT00410410|183192187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.124|TWO_SIDED|95.0|0.48|1.09||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata (whether a participant had an inadequate response and/or intolerance to anti-TNF therapy).|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 mg/kg vs PLA comparison being statistically significant at 5% level, ABA \~10 vs PLA to be tested at 5% significance level.||Null hypothesis=no treatment difference between ABA arm and placebo (PLA) arm. ABA 30/\~10 mg/kg vs PLA: power=98%, sample size=140 per arm,expected PLA response rate=40%, ABA 30/\~10 mg/kg=65%. ABA \~10 mg/kg vs. PLA: power=90%, sample size=140 per arm, 5% significance; expected PLA response rate= 40%, ABA \~10=60%.||1.09|0.48|0.124
91600086|NCT02475655|183091673|SUPERIORITY||Mean Difference (Net)|1.39||||0.031|TWO_SIDED|90.0|1.08|1.79||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 5.||1.79|1.08|0.031
91649990|NCT00410410|183192189|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.06|0.67||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 vs PLA comparison for clinical response being significant at 5% level, this comparison for remission will be tested at 5%.|Conditional on both the remission comparison for ABA 30/\~10 vs PLA, and the clinical response comparison for ABA\~10 vs PLA being significant at 5%, the secondary remission comparison for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference between each of the ABA and placebo (PLA). At 5% significance level, Aba 30/\~10 vs. PLA: power=96%, sample size=140 per arm, expected PLA rate=15%. ABA 30/\~10 =35%; Aba \~10 vs. PLA: power=82%, sample size=140 per arm, expected PLA response rate= 15%, ABA/\~10 mg/kg=30%||0.67|.06|
91785125|NCT03255629|183450398|OTHER|||||||0.875|||||||McNemar|||||||0.875
91785126|NCT01086358|183450438|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.007|TWO_SIDED|95.0|-2.92|-0.49|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.49|-2.92|0.007
91600087|NCT02475655|183091673|SUPERIORITY||Mean Difference (Net)|0.96||||0.93|TWO_SIDED|90.0|0.46|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 12.||2.02|0.46|0.93
91600088|NCT02475655|183091674|SUPERIORITY||Mean Difference (Net)|1.57||||0.43|TWO_SIDED|90.0|0.61|4.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 5.||4.05|0.61|0.43
91600089|NCT02475655|183091674|SUPERIORITY||Mean Difference (Net)|0.68||||0.41|TWO_SIDED|90.0|0.3|1.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 12.||1.50|0.30|0.41
91600090|NCT02475655|183091675|SUPERIORITY||Mean Difference (Net)|-0.34||||0.038|TWO_SIDED|90.0|-0.61|-0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 5.||-0.07|-0.61|0.038
91785127|NCT01086358|183450439|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.01|TWO_SIDED|95.0|-1.79|-0.27|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.27|-1.79|0.010
91600091|NCT02475655|183091675|SUPERIORITY||Mean Difference (Net)|0.27||||0.07|TWO_SIDED|90.0|0.03|0.51||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 12.||0.51|0.03|0.07
91600092|NCT02475655|183091676|SUPERIORITY||Mean Difference (Net)|-0.88||||0.05|TWO_SIDED|90.0|-1.62|-0.13||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-0.13|-1.62|0.05
91600093|NCT02475655|183091676|SUPERIORITY||Mean Difference (Net)|0.86||||0.16|TWO_SIDED|90.0|-0.16|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||1.88|-0.16|0.16
91785128|NCT01086358|183450440|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.059|TWO_SIDED|95.0|-1.39|0.03|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order.||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||0.03|-1.39|0.059
91600094|NCT02475655|183091677|SUPERIORITY||Mean Difference (Net)|-1.71|||<|0.001|TWO_SIDED|90.0|-2.46|-0.97||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 5.||-0.97|-2.46|<0.001
91649991|NCT00410410|183192190|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.42|1.05||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|If ABA 30/\~10 vs PLA remission comparison is significant at 5% level, the mucosal healing comparison for the same treatment group will be tested at 5%|Conditional on both the comparison for mucosal healing for ABA 30/\~10 vs PLA and the comparison for remission for ABA \~10 vs. PLA being significant, the comparison for mucosal healing for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1) for mucosal healing. ABA 30/\~10 vs. placebo: power=99%, sample size=140 per arm, expected PLA response rate=30%, ABA 30/\~10 mg/kg=60%. ABA \~10 vs. placebo: power=98%, sample size=140 per arm, 5% significance; expected PLA response rate= 30%, ABA \~10 mg/kg=55%||1.05|0.42|
91600095|NCT02475655|183091677|SUPERIORITY||Mean Difference (Net)|0.16||||0.68|TWO_SIDED|90.0|-0.5|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 12.||0.82|-0.50|0.68
91600096|NCT02475655|183091678|SUPERIORITY||Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|90.0|-0.7|0.69||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 5.||0.69|-0.70|0.98
91600097|NCT02475655|183091678|SUPERIORITY||Mean Difference (Net)|-0.16||||0.79|TWO_SIDED|90.0|-1.13|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 12.||0.82|-1.13|0.79
91600098|NCT02475655|183091679|SUPERIORITY||Mean Difference (Net)|3.49||||0.001|TWO_SIDED|90.0|1.75|5.22||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 5.||5.22|1.75|0.001
91600099|NCT02475655|183091679|SUPERIORITY||Mean Difference (Net)|-1.3||||0.28|TWO_SIDED|90.0|-3.28|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 12.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|0.68|-3.28|0.28
91600100|NCT02475655|183091680|SUPERIORITY||Mean Difference (Net)|6.54|||<|0.001|TWO_SIDED|90.0|3.76|9.31||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 5.||9.31|3.76|<0.001
91649992|NCT00410410|183192191|SUPERIORITY_OR_OTHER|||||||0.044||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms.||||0.044
91649993|NCT00410410|183192197|SUPERIORITY_OR_OTHER|||||||0.149||||||All statistical testing was performed at a pre-specified alpha-level of 5%|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.149
91649994|NCT00106028|183192246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.438||||0.0625|TWO_SIDED|95.0|-0.235|9.111|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.111|-0.235|0.0625
91785129|NCT01086358|183450441|SUPERIORITY||Odds Ratio (OR)|2.89||||0.016|TWO_SIDED|95.0|1.22|6.84|||Regression, Logistic|As noted above, results are adjusted for study period and treatment order.||Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..||6.84|1.22|0.016
91600101|NCT02475655|183091680|SUPERIORITY||Mean Difference (Net)|-0.19||||0.92|TWO_SIDED|90.0|-3.56|3.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 12.||3.18|-3.56|0.92
91785130|NCT00312195|183450493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|STANDARD_ERROR_OF_MEAN|0.2544||0.0217|TWO_SIDED|95.0|1.09|2.95||P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).|Regression, Logistic||Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.|H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.||2.95|1.09|.0217
91649995|NCT00106028|183192247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.537||||0.6103|TWO_SIDED|95.0|-4.424|7.497|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.497|-4.424|0.6103
91649996|NCT00106028|183192248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.554||||0.0808||95.0|-0.193|3.301|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.301|-0.193|0.0808
91649997|NCT00106028|183192249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.498||||0.6466|TWO_SIDED|95.0|-1.648|2.644|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.644|-1.648|0.6466
91649998|NCT00106028|183192250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.465||||0.7391|TWO_SIDED|95.0|-3.224|2.294|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.294|-3.224|0.7391
91649999|NCT00106028|183192251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.333|||<|0.0001||95.0|5.258|15.408|||ANCOVA|LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||15.408|5.258|<0.0001
91785131|NCT04145219|183450507|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average daily TCRS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.4|0.5|<0.0001
91785132|NCT04145219|183450508|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.0001|TWO_SIDED|95.0|0.2|0.6||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.6|0.2|<0.0001
91600102|NCT02475655|183091681|SUPERIORITY||Mean Difference (Net)|-0.07||||0.82|TWO_SIDED|90.0|-0.61|0.47||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 5.||0.47|-0.61|0.82
91600103|NCT02475655|183091681|SUPERIORITY||Mean Difference (Net)|0.76||||0.033|TWO_SIDED|90.0|0.18|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 12.||1.34|0.18|0.033
91785133|NCT04145219|183450509|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0016|TWO_SIDED|95.0|0.2|0.8||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis|||The average rhinitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.8|0.2|0.0016
91785134|NCT04145219|183450510|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.0001|TWO_SIDED|95.0|0.6|1.7||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs.12 SQ-HDM|||1.7|0.6|<0.0001
91785135|NCT04145219|183450511|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.7|0.3|<0.0001
91600104|NCT02475655|183091682|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|90.0|-0.53|0.55||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 5.||0.55|-0.53|0.98
91600105|NCT02475655|183091682|SUPERIORITY||Mean Difference (Net)|0.55||||0.37|TWO_SIDED|90.0|-0.46|1.57||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 12.||1.57|-0.46|0.37
91650000|NCT00106028|183192252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.04||||1789|TWO_SIDED|95.0|-2.807|14.887|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||14.887|-2.807|01789
91650001|NCT00106028|183192253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.9646|TWO_SIDED|95.0|-12.196|12.755|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||12.755|-12.196|0.9646
91650002|NCT00106028|183192254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.494||||0.003||95.0|1.912|9.077|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.077|1.912|0.0030
91650003|NCT00106028|183192255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.473||||0.6106|TWO_SIDED|95.0|-4.245|7.192|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.192|-4.245|0.6106
91600106|NCT02475655|183091683|SUPERIORITY||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|90.0|-4.72|-1.87||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 5.||-1.87|-4.72|<0.001
91650004|NCT00106028|183192256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315||||0.9372|TWO_SIDED|95.0|-7.598|8.229|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||8.229|-7.598|0.9372
91790467|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.257||0.362|TWO_SIDED|95.0|-0.74|0.27||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.270|-0.740|0.362
91790468|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790469|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.256||0.78|TWO_SIDED|95.0|-0.432|0.575||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.575|-0.432|0.780
91790470|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91600107|NCT02475655|183091683|SUPERIORITY||Mean Difference (Net)|-0.73||||0.09|TWO_SIDED|90.0|-1.42|-0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 12.||-0.03|-1.42|0.09
91600108|NCT02475655|183091684|SUPERIORITY||Mean Difference (Net)|-5.4|||<|0.001|TWO_SIDED|90.0|-7.29|-3.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 5.||-3.50|-7.29|<0.001
91790471|NCT02880956|183460065|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.263||0.974|TWO_SIDED|95.0|-0.526|0.509||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.509|-0.526|0.974
91785136|NCT04145219|183450512|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0018|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|0.2|0.0018
91522576|NCT00855062|182920192|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053||||0.613|TWO_SIDED|95.0|0.043|0.062||The p-value is not adjusted for multiple comparisons.|Fisher Exact|||"The null hypothesis is that the percentage of participants feeling better in the minocycline group after 24 week treatment is the same as the one in the placebo group."||0.062|0.043|0.613
91522577|NCT00855062|182920193|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.661
91522578|NCT00855062|182920194|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the 48-week survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.941
91785137|NCT04145219|183450513|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.2||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The overall PRQLQ score was analysed using a linear mixed effect (LME) model. The model includes the overall PRQLQ score as response variable, treatment and cohort as fixed factors, the baseline overall PRQLQ score as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.1|<0.0001
91785138|NCT04145219|183450514|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.0259|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average asthma DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.0|0.0259
91785139|NCT04145219|183450515|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0527|TWO_SIDED|95.0|1.0|3.3|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a SABA free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included SABA free day (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average asthma DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day where a subject with asthma did not use SABA, odds ratio is (odds active/odds Placebo).||3.3|1.0|0.0527
91785140|NCT04145219|183450516|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1256|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The endpoint was analysed using a linear mixed effect (LME) model. The model includes the endpoint as response variable, treatment and cohort as fixed factors, the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|-0.1|0.1256
91785141|NCT04145219|183450517|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0008|TWO_SIDED|95.0|1.3|2.5|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis mild day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis TCRS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day with no or mild rhinitis symptoms, odds ratio is (odds 12 SQ-HDM / odds Placebo).||2.5|1.3|0.0008
91785142|NCT04145219|183450518|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis exacerbation day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a rhinitis exacerbation day, odds ratio is (odds 12 SQ-HDM / odds Placebo).||0.7|0.4|<0.0001
91785143|NCT04145219|183450519|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
91785144|NCT04145219|183450520|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
91785145|NCT05871450|183450540|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
91790472|NCT02880956|183460065|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790473|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.139||0.976|TWO_SIDED|95.0|-0.269|0.278||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.278|-0.269|0.976
91790474|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||Week 24||||
91600109|NCT02475655|183091684|SUPERIORITY||Mean Difference (Net)|-1.23||||0.11|TWO_SIDED|90.0|-2.51|0.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 12.||0.05|-2.51|0.11
91600110|NCT02475655|183091685|SUPERIORITY||Mean Difference (Net)|-1.54||||0.26|TWO_SIDED|90.0|-3.78|0.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 5.||0.70|-3.78|0.26
91600111|NCT02475655|183091685|SUPERIORITY||Mean Difference (Net)|-0.39||||0.74|TWO_SIDED|90.0|-2.41|1.62||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 12.||1.62|-2.41|0.74
91600112|NCT02475655|183091686|SUPERIORITY||Mean Difference (Net)|0.55||||0.71|TWO_SIDED|90.0|-1.9|3.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 5.||3.00|-1.90|0.71
91600113|NCT02475655|183091686|SUPERIORITY||Mean Difference (Net)|0.31||||0.83|TWO_SIDED|90.0|-2.15|2.78||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 12.||2.78|-2.15|0.83
91600114|NCT02475655|183091687|SUPERIORITY||Mean Difference (Net)|-1.33||||0.01|TWO_SIDED|90.0|-2.16|-0.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 5.||-0.50|-2.16|0.010
91600115|NCT02475655|183091687|SUPERIORITY||Mean Difference (Net)|-0.17||||0.74|TWO_SIDED|90.0|-1.02|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 12.||0.68|-1.02|0.74
91650005|NCT00106028|183192257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.675|||<|0.0001||95.0|21.051|42.3|||ANCOVA|LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||42.300|21.051|<0.0001
91650006|NCT00106028|183192258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.029||||0.0793|TWO_SIDED|95.0|-1.667|29.726|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||29.726|-1.667|0.0793
91785146|NCT01303224|183450548|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted by using the Hochberg Procedure.|Mantel Haenszel|||Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.||||<0.05
91785147|NCT01303224|183450549|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted using the Hochberg procedure.|Mantel Haenszel|||||||<0.05
91600116|NCT02475655|183091688|SUPERIORITY||Mean Difference (Net)|-3.24||||0.008|TWO_SIDED|90.0|-5.22|-1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-1.27|-5.22|0.008
91790475|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.137||0.85|TWO_SIDED|95.0|-0.244|0.296||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.296|-0.244|0.850
91790476|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790477|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.981|TWO_SIDED|95.0|-0.281|0.275||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.275|-0.281|0.981
91790478|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790479|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.163||0.989|TWO_SIDED|95.0|-0.323|0.318||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.318|-0.323|0.989
91650007|NCT00106028|183192259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.567|||<|0.0001||95.0|5.59|11.545|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.545|5.590|<0.0001
91650008|NCT00106028|183192260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.315||||0.4575|TWO_SIDED|95.0|-10.477|23.107|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.107|-10.477|0.4575
91650009|NCT00106028|183192261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.594||||0.0172||95.0|6.801|68.386|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||68.386|6.801|0.0172
91650010|NCT00106028|183192262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.492||||0.9786|TWO_SIDED|95.0|-36.807|35.824|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||35.824|-36.807|0.9786
91650011|NCT00106028|183192263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.64||||0.5971|TWO_SIDED|95.0|-40.952|23.672|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.672|-40.952|0.5971
91785148|NCT01888432|183450553|NON_INFERIORITY|HO: πT - πC ≥ 0.12 vs. HA: πT - πC \< 0.12, where πT and πC are the true proportions of composite efficacy failure of tBPAR, GL, or D, (tBPAR/GL/D) at 12 months post-transplant for the respective treatment groups. The proportion of 0.12, or 12%, was pre-determined as the non-inferiority (NI) margin for composite efficacy failure.|Kaplan-Meier|-0.7|||<|0.001|TWO_SIDED|90.0|-5.2|3.7||Z-test p-value for non-inferiority test (non-inferiority margin = 12%) is for one-sided test and should be compared to 0.05 significance level.|Z-test|||non-inferior efficacy failure of the reduced tacrolimus regimen to control by rejecting the null hypothesis.||3.7|-5.2|< 0.001
91785149|NCT01888432|183450554|NON_INFERIORITY|the null hypothesis below was tested at the one-sided α = 0.05 level: H0: μT - μC ≤ -6 mL/min/1.73 m2 vs. HA: μT - μC \> -6 mL/min/1.73 m\^2, where μT and μC are the true means of change in eGFR (MDRD-4) from randomization to Month 12 post-transplant for the reduced tacrolimus group and control group, respectively.|Mean Difference (Net)|4.15|STANDARD_ERROR_OF_MEAN|2.574|<|0.001|TWO_SIDED|90.0|-0.09|8.4|||ANCOVA|||||8.40|-0.09|< 0.001
91785150|NCT01888432|183450555|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.699|<|0.001|TWO_SIDED|90.0|-1.21|7.7|||ANCOVA|||||7.70|-1.21|<0.001
91785151|NCT01888432|183450557|OTHER|Month 12|Kaplan-Meier|-1.4|||||TWO_SIDED|90.0|-4.7|2.0|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.0|-4.7|
91785152|NCT01888432|183450557|OTHER|tBPAR - month 24|Kaplan-Meier|-1.2|||||TWO_SIDED|90.0|-5.1|2.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.6|-5.1|
91785153|NCT01888432|183450557|OTHER|On-treatment tBPAR - month 24|Kaplan-Meier|-2.1|||||TWO_SIDED|90.0|-5.7|1.4|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||1.4|-5.7|
91785154|NCT01888432|183450558|OTHER|Month 12|Kaplan-Meier|0.9|||||TWO_SIDED|90.0|-3.4|5.1|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.1|-3.4|
91785155|NCT01888432|183450558|OTHER|Month 24|Kaplan-Meier|1.0|||||TWO_SIDED|90.0|-3.6|5.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.6|-3.6|
91785156|NCT01888432|183450559|OTHER|graft loss at month 24|Kaplan-Meier|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||0.5|-2.1|
91785157|NCT01888432|183450560|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
91785158|NCT01888432|183450560|OTHER|Month 24|Kaplan-Meier|2.3|||||TWO_SIDED|90.0|-2.1|6.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||6.6|-2.1|
91600117|NCT02475655|183091688|SUPERIORITY||Median Difference (Net)|-0.17||||0.9|TWO_SIDED|90.0|-2.38|2.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||2.05|-2.38|0.90
91600118|NCT02475655|183091691|SUPERIORITY||Mean Difference (Net)|1.39||||0.47|TWO_SIDED|90.0|-1.83|4.61||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 5.||4.61|-1.83|0.47
91600119|NCT02475655|183091691|SUPERIORITY||Mean Difference (Net)|2.21||||0.22|TWO_SIDED|90.0|-0.77|5.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 12.||5.18|-0.77|0.22
91600120|NCT02475655|183091692|SUPERIORITY||Mean Difference (Net)|-4.34||||0.28|TWO_SIDED|90.0|-11.0|2.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 5.||2.35|-11.0|0.28
91600121|NCT02475655|183091692|SUPERIORITY||Mean Difference (Net)|-9.81||||0.019|TWO_SIDED|90.0|-16.6|-3.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 12.||-3.02|-16.6|0.019
91600122|NCT02475655|183091693|SUPERIORITY||Mean Difference (Net)|-0.81||||0.55|TWO_SIDED|90.0|-3.02|1.41||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 5.||1.41|-3.02|0.55
91600123|NCT02475655|183091693|SUPERIORITY||Mean Difference (Net)|-1.7||||0.09|TWO_SIDED|90.0|-3.36|-0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 12.||-0.04|-3.36|0.09
91600124|NCT02475655|183091694|SUPERIORITY||Mean Difference (Net)|-1.47||||0.15|TWO_SIDED|90.0|-3.17|0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 5.||0.23|-3.17|0.15
91600125|NCT02475655|183091694|SUPERIORITY||Mean Difference (Net)|-1.62||||0.37|TWO_SIDED|90.0|-4.59|1.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 12.||1.35|-4.59|0.37
91600126|NCT02475655|183091695|SUPERIORITY||Mean Difference (Net)|-0.86||||0.39|TWO_SIDED|90.0|-2.51|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 5.||0.80|-2.51|0.39
91600127|NCT02475655|183091695|SUPERIORITY||Mean Difference (Net)|-0.7||||0.54|TWO_SIDED|90.0|-2.59|1.19||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 12.||1.19|-2.59|0.54
91600128|NCT02475655|183091696|SUPERIORITY||Mean Difference (Net)|-6.02||||0.1|TWO_SIDED|90.0|-12.0|-0.06||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 5.||-0.06|-12.0|0.10
91600129|NCT02475655|183091696|SUPERIORITY||Mean Difference (Net)|-6.39||||0.026|TWO_SIDED|90.0|-11.1|-1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 12.||-1.73|-11.1|0.026
91600130|NCT02475655|183091697|SUPERIORITY||Mean Difference (Net)|0.28||||0.95|TWO_SIDED|90.0|-7.26|7.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 5.||7.82|-7.26|0.95
91785159|NCT01888432|183450561|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
91600131|NCT02475655|183091697|SUPERIORITY||Mean Difference (Net)|-4.1||||0.43|TWO_SIDED|90.0|-12.6|4.45||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 12.||4.45|-12.6|0.43
91785160|NCT01888432|183450561|OTHER|Month 24|Kaplan-Meier|3.0|||||TWO_SIDED|90.0|-1.1|7.2|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||7.2|-1.1|
91600132|NCT02475655|183091698|SUPERIORITY||Mean Difference (Net)|1.23||||0.74|TWO_SIDED|90.0|-5.08|7.54||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 5.||7.54|-5.08|0.74
91600133|NCT02475655|183091698|SUPERIORITY||Mean Difference (Net)|3.76||||0.42|TWO_SIDED|90.0|-3.94|11.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 12.||11.5|-3.94|0.42
91600134|NCT02475655|183091699|SUPERIORITY||Mean Difference (Net)|-0.63||||0.66|TWO_SIDED|90.0|-2.99|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 5.||1.73|-2.99|0.66
91600135|NCT02475655|183091699|SUPERIORITY||Mean Difference (Net)|-1.56||||0.27|TWO_SIDED|90.0|-3.93|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 12.||0.80|-3.93|0.27
91600136|NCT02475655|183091700|SUPERIORITY||Mean Difference (Net)|-7.1||||0.013|TWO_SIDED|90.0|-11.7|-2.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 5.||-2.46|-11.7|0.013
91600137|NCT02475655|183091700|SUPERIORITY||Mean Difference (Net)|-1.49||||0.7|TWO_SIDED|90.0|-8.06|5.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 12.||5.07|-8.06|0.70
91600138|NCT02475655|183091701|SUPERIORITY||Mean Difference (Net)|0.01||||0.79|TWO_SIDED|90.0|-0.05|0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 5.||0.07|-0.05|0.79
91600139|NCT02475655|183091701|SUPERIORITY||Mean Difference (Net)|0.01||||0.91|TWO_SIDED|90.0|-0.07|0.08||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 12.||0.08|-0.07|0.91
91650012|NCT00106028|183192264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.014||||0.4154||95.0|-1.442|3.47|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.470|-1.442|0.4154
91650013|NCT00106028|183192265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884||||0.6404|TWO_SIDED|95.0|-2.855|4.623|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.623|-2.855|0.6404
91650014|NCT00106028|183192266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.66||||0.4978|TWO_SIDED|95.0|-6.499|3.179|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.179|-6.499|0.4978
91650015|NCT00106028|183192267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.534||||0.027||95.0|0.41|6.658|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.658|0.410|0.0270
91650016|NCT00106028|183192268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.065||||0.5925|TWO_SIDED|95.0|-2.868|4.998|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.998|-2.868|0.5925
91785161|NCT01888432|183450561|OTHER|Month 24 (On-treatment death)|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.9|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.9|-2.5|
91600140|NCT02475655|183091702|SUPERIORITY||Mean Difference (Net)|-2.85||||0.43|TWO_SIDED|90.0|-8.82|3.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 5.||3.12|-8.82|0.43
91600141|NCT02475655|183091702|SUPERIORITY||Mean Difference (Net)|0.03||||0.99|TWO_SIDED|90.0|-6.53|6.6||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 12.||6.60|-6.53|0.99
91600142|NCT02475655|183091703|SUPERIORITY||Median Difference (Net)|1.88||||0.007|TWO_SIDED|90.0|1.29|2.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 5.||2.73|1.29|0.007
91785162|NCT01888432|183450562|OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|90.0|-3.9|5.3|||||Month 12|||5.3|-3.9|
91785163|NCT01888432|183450562|OTHER||Risk Difference (RD)|2.1|||||TWO_SIDED|90.0|-3.0|7.2|||||Month 24|||7.2|-3.0|
91785164|NCT01888432|183450563|OTHER||Risk Ratio (RR)|-0.7|||||TWO_SIDED|90.0|-4.5|3.1|||||Month 12|||3.1|-4.5|
91785165|NCT01888432|183450563|OTHER||Risk Ratio (RR)|0.0|||||TWO_SIDED|90.0|-4.2|4.2|||||Month 24|||4.2|-4.2|
91785166|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|5.4|||||TWO_SIDED|95.0|-19.9|30.6|||||Composite endpoint|||30.6|-19.9|
91785167|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|6.7|||||TWO_SIDED|95.0|-6.0|19.3|||||On-treatment composite endpoint|||19.3|-6.0|
91785168|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|2.0|||||TWO_SIDED|95.0|-24.6|28.7|||||Graft loss/death|||28.7|-24.6|
91785169|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tBPAR|||33.1|-4.2|
91785170|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|11.1|||||TWO_SIDED|95.0|-9.4|31.6|||||Death|||31.6|-9.4|
91785171|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||AR|||35.2|-28.9|
91785172|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tAR|||33.1|-4.2|
91785173|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|14.9|||||TWO_SIDED|95.0|-22.3|52.1|||||BPR|||52.1|-22.3|
91785174|NCT01888432|183450567|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||BPAR|||35.2|-28.9|
91785175|NCT01888432|183450568|OTHER||Mean Difference (Final Values)|-10.01|STANDARD_ERROR_OF_MEAN|22.059|||TWO_SIDED|95.0|-59.91|39.89||||||||39.89|-59.91|
91785176|NCT01954927|183450616|SUPERIORITY|||||||0.227||||||1-sided p-value|z-test Proportion|z-test of proportions without continuity correction||||||0.227
91785177|NCT01954927|183450617|SUPERIORITY|||||||0.897|||||||Wilcoxon (Mann-Whitney)|||||||0.897
91785178|NCT01954927|183450618|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.181
91785179|NCT01954927|183450619|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.730
91785180|NCT01954927|183450620|SUPERIORITY|||||||0.713|||||||Chi-squared|||||||0.713
91785181|NCT01954927|183450621|SUPERIORITY|||||||0.739|||||||Wilcoxon (Mann-Whitney)|||||||0.739
91785182|NCT01954927|183450622|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
91785183|NCT00955305|183450637|SUPERIORITY_OR_OTHER|||||||0.33||||||one-sided p-value using stratified logrank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.33
91785184|NCT00955305|183450638|SUPERIORITY_OR_OTHER|||||||0.95||||||two-sided p-value by stratified log rank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.95
91785185|NCT00955305|183450639|SUPERIORITY_OR_OTHER|||||||0.15||||||two sided p-value by Fisher's exact test|Fisher Exact|||||||0.15
91785186|NCT01221285|183450642|SUPERIORITY_OR_OTHER||Fold change|1.8||||0.02|TWO_SIDED|95.0|1.1|2.8|||Fold change||Numerator is geometric mean post-baseline IgE. Denominator is baseline IgE.|||2.8|1.1|0.02
91785187|NCT01221285|183450643|SUPERIORITY_OR_OTHER||Fold change|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.4|||Fold change||Numerator is geometric mean post-baseline IgG. Denominator is baseline IgG.|||3.4|1.8|<0.0001
91785188|NCT01221285|183450644|SUPERIORITY_OR_OTHER||Fold change|12.9|||<|0.0001|TWO_SIDED|95.0|7.5|22.5|||Fold Change||Numerator is geometric mean post-baseline IgG4. Denominator is baseline IgG4.|||22.5|7.5|<0.0001
91785189|NCT01221285|183450645|SUPERIORITY_OR_OTHER||Change|-42.8|||<|0.0001|TWO_SIDED|95.0|-59.4|-26.2|||Change||Numerator is geometric mean post-baseline FAB. Denominator is baseline FAB.|||-26.2|-59.4|<0.0001
91785190|NCT02123251|183450646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.2139||0.0553|TWO_SIDED|95.0|-0.0092|0.8293|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, race, gender, and baseline hypertension.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||0.8293|-0.0092|0.0553
91790480|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790481|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.97|TWO_SIDED|95.0|-0.319|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.307|-0.319|0.970
91522579|NCT00855062|182920195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.11|STANDARD_ERROR_OF_MEAN|17.63||0.647|TWO_SIDED|95.0|-27.23|43.45||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 24-week change of CD4 cell counts in the minocycline group is the same as the one in the placebo group.||43.45|-27.23|0.647
91600143|NCT02475655|183091703|SUPERIORITY||Mean Difference (Net)|1.31||||0.23|TWO_SIDED|90.0|0.9|1.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 12.||1.90|0.90|0.23
91785191|NCT02123251|183450647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2916|STANDARD_ERROR_OF_MEAN|1.9571||0.2416|TWO_SIDED|95.0|-6.1274|1.5442|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.5442|-6.1274|0.2416
91600144|NCT02475655|183091704|SUPERIORITY||Mean Difference (Net)|1.22||||0.32|TWO_SIDED|90.0|0.87|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 5.||1.72|0.87|0.32
91600145|NCT02475655|183091704|SUPERIORITY||Mean Difference (Net)|1.03||||0.91|TWO_SIDED|90.0|0.68|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 12.||1.56|0.68|0.91
91600146|NCT02475655|183091705|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5).||||0.40
91600147|NCT02475655|183091705|SUPERIORITY|||||||0.87||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any post-treatment time point (ever shedding at weeks 10 or 12).||||0.87
91600148|NCT02475655|183091709|SUPERIORITY||Mean Difference (Net)|0.53||||0.4|TWO_SIDED|90.0|0.15|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 5.||1.88|0.15|0.40
91600149|NCT02475655|183091709|SUPERIORITY||Mean Difference (Net)|0.92||||0.93|TWO_SIDED|90.0|0.2|4.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 12.||4.34|0.20|0.93
91600150|NCT00353418|183091710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6119||95.0|0.68|1.93|||Cochran-Mantel-Haenszel|||"Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83"||1.93|0.68|0.6119
91600151|NCT00355394|183091740|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
91600152|NCT00355394|183091741|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
91600153|NCT00355394|183091742|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
91600154|NCT00355394|183091743|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91600155|NCT00355394|183091744|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
91600156|NCT00355394|183091745|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.50
91600157|NCT01175902|183091749|NON_INFERIORITY_OR_EQUIVALENCE|"To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.~In this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP."|Mean Difference (Final Values)|0.9||||0.05|TWO_SIDED|||||Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|t-test, 2 sided|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.||||0.05
91600158|NCT00699907|183091764|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon Rank Sum Test|||||||0.012
91790482|NCT02880956|183460066|SUPERIORITY||effect size|0.0|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91600159|NCT00699907|183091764|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
91650017|NCT00106028|183192269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.193||||0.684|TWO_SIDED|95.0|-4.604|6.991|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.991|-4.604|0.6840
91650018|NCT00106028|183192270|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.0680
91600160|NCT00699907|183091765|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
91600161|NCT00699907|183091765|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
91600162|NCT00699907|183091766|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon Rank Sum Test|||||||0.0006
91600163|NCT00699907|183091766|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
91600164|NCT00699907|183091767|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Rank Sum Test|||||||0.009
91600165|NCT00699907|183091767|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
91600166|NCT00699907|183091768|SUPERIORITY_OR_OTHER|||||||0.037|||||||Wilcoxon Rank Sum Test|||||||0.037
91600167|NCT00699907|183091768|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
91600168|NCT00699907|183091769|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
91650019|NCT00106028|183192271|SUPERIORITY_OR_OTHER|||||||0.4121||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.4121
91790483|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.215|TWO_SIDED|95.0|-0.526|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.526|0.215
91600169|NCT00699907|183091769|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
91522580|NCT00855062|182920196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.77|STANDARD_ERROR_OF_MEAN|32.51||0.813|TWO_SIDED|95.0|-59.07|74.6||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 48-week change in CD4 cell counts in the minocycline group is the same as the one in the placebo group.||74.60|-59.07|0.813
91600170|NCT00699907|183091770|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
91790484|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790485|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.163||0.665|TWO_SIDED|95.0|-0.392|0.25||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.250|-0.392|0.665
91790486|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91600171|NCT00699907|183091770|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
91600172|NCT00699907|183091771|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Rank Sum Test|||||||0.006
91600173|NCT00699907|183091771|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
91600174|NCT00699907|183091772|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
91600175|NCT00699907|183091772|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
91600176|NCT01081795|183091773|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.4||||0.1646|TWO_SIDED|95.0|-1.0|0.2||Analysis of covariance (ANCOVA) method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1646
91600177|NCT01081795|183091773|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4479|TWO_SIDED|95.0|-0.8|0.4||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.4|-0.8|0.4479
91600178|NCT01081795|183091774|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1547|TWO_SIDED|95.0|-1.1|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.1|0.1547
91600179|NCT01081795|183091774|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2624|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2624
91600180|NCT01081795|183091775|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2464|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2464
91600181|NCT01081795|183091775|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3148|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.3148
91600182|NCT01081795|183091776|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.8762|TWO_SIDED|95.0|-0.6|0.5||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.5|-0.6|0.8762
91600183|NCT01081795|183091776|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3031|TWO_SIDED|95.0|-0.8|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-0.8|0.3031
91600184|NCT01081795|183091777|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.1145|TWO_SIDED|95.0|-0.7|0.1||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.1|-0.7|0.1145
91600185|NCT01081795|183091777|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.3971|TWO_SIDED|95.0|-0.6|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-0.6|0.3971
91600186|NCT01081795|183091778|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1866|TWO_SIDED|95.0|-1.3|0.3||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.3|0.1866
91600187|NCT01081795|183091778|SUPERIORITY_OR_OTHER||LS mean difference|-0.6||||0.1507|TWO_SIDED|95.0|-1.4|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.4|0.1507
91600188|NCT01081795|183091780|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.1743|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1743
91600189|NCT01081795|183091780|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2165|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.2165
91600190|NCT01081795|183091781|SUPERIORITY_OR_OTHER||Percentage difference|5.1||||0.3083|TWO_SIDED|95.0|-3.8|14.0||Month 6|Fisher Exact|||||14.0|-3.8|0.3083
91600191|NCT01081795|183091781|SUPERIORITY_OR_OTHER||Percentage difference|2.0||||0.7235|TWO_SIDED|95.0|-6.6|10.6||Month 6|Fisher Exact|||||10.6|-6.6|0.7235
91600192|NCT03138876|183091798|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
91600193|NCT03889639|183091802|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95 percentage (%) confidence interval (CI) were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-56.16||||0.1673|TWO_SIDED|95.0|-193.99|17.05|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||17.05|-193.99|0.1673
91522581|NCT00855062|182920197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|STANDARD_ERROR_OF_MEAN|0.82||0.764||95.0|0.26|6.34||The p-value is not adjusted for multiple comparisons.|Regression, Logistic|"The model was not adjusted for any covariate (due to small number of being better in both groups."||"The null hypothesis is that the percentage of being better at week 24 compared to baseline in the minocycline group is the same as the one in the placebo group."||6.34|0.26|0.764
91600194|NCT03889639|183091802|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.8||||0.354|TWO_SIDED|95.0|-356.24|41.91|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||41.91|-356.24|0.3540
91600195|NCT03889639|183091802|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|13.49||||0.7674|TWO_SIDED|95.0|-126.05|66.89|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||66.89|-126.05|0.7674
91650020|NCT00106028|183192272|SUPERIORITY_OR_OTHER|||||||0.3658||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3658
91600196|NCT03889639|183091802|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|85.02||||0.0178|TWO_SIDED|95.0|28.02|96.88|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.88|28.02|0.0178
91600197|NCT03889639|183091803|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|10.17||||0.7736|TWO_SIDED|95.0|-86.49|56.73|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||56.73|-86.49|0.7736
91600198|NCT03889639|183091803|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|37.07||||0.248|TWO_SIDED|95.0|-38.08|71.32|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||71.32|-38.08|0.2480
91600199|NCT03889639|183091803|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|38.5||||0.3081|TWO_SIDED|95.0|-56.61|75.85|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||75.85|-56.61|0.3081
91600200|NCT03889639|183091803|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|89.34||||0.0001|TWO_SIDED|95.0|68.39|96.41|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.41|68.39|0.0001
91600201|NCT03889639|183091804|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.16||||0.1525|TWO_SIDED|95.0|-214.44|16.38|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||16.38|-214.44|0.1525
91600202|NCT03889639|183091804|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-47.38||||0.4606|TWO_SIDED|95.0|-312.91|47.4|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||47.40|-312.91|0.4606
91600203|NCT03889639|183091804|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|2.9||||0.949|TWO_SIDED|95.0|-138.96|60.54|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||60.54|-138.96|0.9490
91600204|NCT03889639|183091804|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|65.05||||0.2324|TWO_SIDED|95.0|-96.21|93.77|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||93.77|-96.21|0.2324
91600205|NCT01707693|183091808|SUPERIORITY|repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.||||||0.023||||||P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.|ANCOVA|||||||0.023
91785192|NCT02123251|183450648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0893|STANDARD_ERROR_OF_MEAN|1.2622||0.3881|TWO_SIDED|95.0|-3.5632|1.3846|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.3846|-3.5632|0.3881
91785193|NCT02123251|183450649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3432|STANDARD_ERROR_OF_MEAN|7.7086||0.8617|TWO_SIDED|95.0|-16.4517|13.7653|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||13.7653|-16.4517|0.8617
91790487|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.162||0.059|TWO_SIDED|95.0|-0.625|0.012||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.012|-0.625|0.059
91785194|NCT02123251|183450650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.787|STANDARD_ERROR_OF_MEAN|28.5519||0.5333|TWO_SIDED|95.0|-73.7478|38.1737|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||38.1737|-73.7478|0.5333
91600206|NCT01707693|183091809|SUPERIORITY|||||||0.011||||||\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|ANCOVA|\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.||||||0.011
91600207|NCT01707693|183091810|OTHER|2-sided Wilcoxon Rank Sum test||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
91600208|NCT01707693|183091811|OTHER|counts of stage of change||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Armitage trend test||||||.001
91785195|NCT02123251|183450651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9097|STANDARD_ERROR_OF_MEAN|5.2351||0.862|TWO_SIDED|95.0|-9.3509|11.1702|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||11.1702|-9.3509|0.8620
91522582|NCT00855062|182920198|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||The p-value is not adjusted for multiple comparisons.|Kruskal-Wallis|The chi-square score was 0.024 and the degree of freedom was 1.||The null hypothesis is that the median log10-transformed HIV RNA viral loads in the minocycline group is the same as the one in the placebo group.||||0.766
91600209|NCT00993031|183091823|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.76|TWO_SIDED|95.0|0.26|2.67|||Chi-squared|||||2.67|.26|.76
91600210|NCT00993031|183091824|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.76|TWO_SIDED|95.0|0.29|2.46|||Chi-squared|||||2.46|.29|.76
91600211|NCT00993031|183091825|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.45|TWO_SIDED|95.0|0.36|1.59|||Chi-squared|||||1.59|.36|.45
91600212|NCT00993031|183091827|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.66|||Chi-squared|||||1.66|.89|.21
91600213|NCT00993031|183091828|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.06|TWO_SIDED|95.0|0.98|1.83|||Chi-squared|||||1.83|.98|.06
91600214|NCT03506295|183091838|OTHER||Odds Ratio (OR)|0.496||||0.7878|TWO_SIDED|95.0|0.168|1.469|||Regression, Logistic|||||1.469|0.168|0.7878
91613664|NCT02078713|183121548|SUPERIORITY||Relative risk ratio|1.0||||0.997|TWO_SIDED|95.0|0.45|2.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).||2.25|0.45|0.997
91613665|NCT02078713|183121548|SUPERIORITY||Relative risk ratio|0.69||||0.16|TWO_SIDED|95.0|0.41|1.16||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).||1.16|0.41|0.16
91613666|NCT02078713|183121549|SUPERIORITY|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|Odds Ratio (OR)|1.3||||0.13|TWO_SIDED|95.0|0.93|1.82||P-value calculated in multiply imputed dataset.|Regression, Logistic||The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.82|0.93|0.13
91613667|NCT02078713|183121550|SUPERIORITY||Relative risk ratio|1.13||||0.5|TWO_SIDED|95.0|0.79|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patient decision to both (ref)||1.61|0.79|0.50
91613668|NCT02078713|183121550|SUPERIORITY||Relative risk ratio|2.14||||0.09|TWO_SIDED|95.0|0.89|5.15||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of provider decision to both (ref)||5.15|0.89|0.09
91522583|NCT00855062|182920199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|1.79||0.915|TWO_SIDED|95.0|-3.4|3.78||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CES-D and MSK scores.||The null hypothesis is that the mean 24-week change of CES-D score in the minocycline group is the same as the one in the placebo group.||3.78|-3.40|0.915
91710806|NCT02258217|183314019|EQUIVALENCE|"We created a difference in SAGE score variable. This was calculated as follows:~SAGE score (new relapse) - SAGE score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the difference in medians is -1 to 0.|"We compared the two SAGE scores measured in the same arm at different time points (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post SAGE scores."||||0.44
91710807|NCT01806168|183314022|OTHER|||||||0.046|||||||Mixed Models Analysis|||||||0.046
91710808|NCT01806168|183314022|EQUIVALENCE|a \< 0.05||||||0.021|||||||t-test, 2 sided|||||||0.021
91790488|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91600215|NCT00848354|183091890|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.||||<0.0001
91600216|NCT00848354|183091891|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||<0.0001
91600217|NCT00848354|183091892|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.||||0.0003
91600218|NCT00848354|183091892|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.||||0.0002
91600219|NCT00848354|183091892|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.||||<0.0001
91600220|NCT00848354|183091893|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.||||0.0270
91600221|NCT00848354|183091894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600222|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.39|||<|0.0001|TWO_SIDED|95.0|2.25|18.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||18.2|2.25|<0.0001
91600223|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.62|9.49||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||9.49|2.62|<0.0001
91600224|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|2.19|5.94||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.94|2.19|<0.0001
91600225|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.57|6.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.53|2.57|<0.0001
91600226|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.51|6.16||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.16|2.51|<0.0001
91600227|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.46|5.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||5.93|2.46|<0.0001
91600228|NCT00848354|183091897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.41|8.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||8.53|3.41|<0.0001
91600229|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.37|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.21|2.37|<0.0001
91600230|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|2.19|5.11||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.11|2.19|<0.0001
91600231|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.9|4.43||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||4.43|1.90|<0.0001
91600232|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.06|4.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||4.96|2.06|<0.0001
91600233|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.91|||<|0.0001|TWO_SIDED|95.0|2.46|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.21|2.46|<0.0001
91600234|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.45|6.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.22|2.45|<0.0001
91600235|NCT00848354|183091899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.94|||<|0.0001|TWO_SIDED|95.0|3.13|7.78||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.78|3.13|<0.0001
91600236|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.19||||0.1086|TWO_SIDED|95.0|0.66|40.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||40.9|0.66|0.1086
91600237|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.0392|TWO_SIDED|95.0|1.04|12.3||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||12.3|1.04|0.0392
91650021|NCT00106028|183192273|SUPERIORITY_OR_OTHER|||||||0.3408||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3408
91710809|NCT01806168|183314022|EQUIVALENCE|a \< 0.05||||||0.65|||||||t-test, 2 sided|||||||0.65
91600238|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.04|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||13.6|2.04|<0.0001
91710810|NCT01806168|183314023|OTHER|||||||0.93|||||||Mixed Models Analysis|||To test primary and secondary outcomes, we utilized intention to treat data and linear mixed models with a group random effect. Significance was set to a \< 0.05.||||0.93
91600239|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.69|||<|0.0001|TWO_SIDED|95.0|2.39|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||13.6|2.39|<0.0001
91600240|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.02|7.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||7.09|2.02|<0.0001
91600241|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.02|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.60|2.02|<0.0001
91600242|NCT00848354|183091901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.36|7.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.46|2.36|<0.0001
91600243|NCT00848354|183091903|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600244|NCT00848354|183091905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.23|||<|0.0001|TWO_SIDED|95.0|3.88|10.0||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||10.00|3.88|<0.0001
91600245|NCT00848354|183091906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.79|||<|0.0001|TWO_SIDED|95.0|3.49|17.39||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||17.39|3.49|<0.0001
91710811|NCT01806168|183314024|OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
91600246|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.24|5.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.46|2.24|<0.0001
91600247|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.91|8.55||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||8.55|2.91|<0.0001
91600248|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.93|12.02||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||12.02|2.93|<0.0001
91600249|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57|||<|0.0001|TWO_SIDED|95.0|2.27|9.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.21|2.27|<0.0001
91600250|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|2.74|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|2.74|<0.0001
91600251|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86|||<|0.0001|TWO_SIDED|95.0|3.0|15.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.72|3.00|<0.0001
91600252|NCT00848354|183091907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.64|||<|0.0001|TWO_SIDED|95.0|3.74|15.63||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.63|3.74|<0.0001
91600253|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||4.86|2.04|<0.0001
91785196|NCT02123251|183450652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7177|STANDARD_ERROR_OF_MEAN|1.0433||0.4915|TWO_SIDED|95.0|-1.3272|2.7626|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||2.7626|-1.3272|0.4915
91600254|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.85|6.82||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.82|2.85|<0.0001
91600255|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.5|6.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.38|2.50|<0.0001
91710812|NCT01806168|183314025|OTHER|||||||0.54|||||||Mixed Models Analysis|||||||0.54
91710813|NCT01806168|183314026|OTHER|||||||0.86|||||||Mixed Models Analysis|||||||0.86
91600256|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.37|6.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.41|2.37|<0.0001
91600257|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.19|9.76||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.76|3.19|<0.0001
91600258|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|3.16|9.52||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||9.52|3.16|<0.0001
91600259|NCT00848354|183091909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.87|11.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.21|3.87|<0.0001
91600260|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.3|5.4||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.40|2.30|<0.0001
91600261|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|||<|0.0001|TWO_SIDED|95.0|3.07|7.71||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.71|3.07|<0.0001
91600262|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001|TWO_SIDED|95.0|2.98|8.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.41|2.98|<0.0001
91710814|NCT01806168|183314027|OTHER|||||||0.4|||||||Mixed Models Analysis|||||||0.4
91650022|NCT00106028|183192276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253||95.0|0.31|0.922||All Fractures|Cox proportional hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
91710815|NCT01100723|183314035|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
91522584|NCT02755597|182920200|SUPERIORITY||Hazard Ratio (HR)|0.656|||=|0.012|TWO_SIDED|95.0|0.471|0.913|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.913|0.471|=0.012
91522585|NCT02755597|182920201|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
91522586|NCT02755597|182920203|SUPERIORITY||Hazard Ratio (HR)|0.508|||<|0.001|TWO_SIDED|95.0|0.343|0.753|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.753|0.343|<0.001
91522587|NCT02755597|182920208|SUPERIORITY||Hazard Ratio (HR)|1.191|||=|0.385|TWO_SIDED|95.0|0.802|1.77|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||1.770|0.802|=0.385
91522588|NCT02755597|182920209|SUPERIORITY||Hazard Ratio (HR)|0.571|||=|0.001|TWO_SIDED|95.0|0.405|0.805|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.805|0.405|=0.001
91522589|NCT02755597|182920210|SUPERIORITY||||||=|0.019|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||=0.019
91522590|NCT02755597|182920211|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
91522591|NCT04252742|182920212|SUPERIORITY||LSM difference|-7.95|||<|0.001|TWO_SIDED|95.0|-11.45|-4.46||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-4.46|-11.45|< 0.001
91522592|NCT04252742|182920213|SUPERIORITY||LSM difference|-7.36|||<|0.001|TWO_SIDED|95.0|-10.8|-3.92||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-3.92|-10.80|< 0.001
91522593|NCT04252742|182920214|SUPERIORITY||LSM difference|-7.1|||<|0.001|TWO_SIDED|95.0|-10.34|-3.87||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.87|-10.34|< 0.001
91522594|NCT04252742|182920215|SUPERIORITY||LSM difference|-7.05|||<|0.001|TWO_SIDED|95.0|-10.76|-3.34||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.34|-10.76|< 0.001
91522595|NCT04252742|182920216|SUPERIORITY||LSM difference|-6.82|||<|0.001|TWO_SIDED|95.0|-10.37|-3.27||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.27|-10.37|< 0.001
91522596|NCT04252742|182920217|SUPERIORITY||LSM difference|-1.07||||0.013|TWO_SIDED|95.0|-1.92|-0.22||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-0.22|-1.92|0.013
91522597|NCT04252742|182920218|SUPERIORITY||LSM difference|-0.48||||0.011|TWO_SIDED|95.0|-0.85|-0.11||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-0.11|-0.85|0.011
91522598|NCT01091948|182920225|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Regression, Cox|Intubations accomplished with another device due to difficulty with assigned device and those took \>180 s were considered as failed intubations.||||||0.19
91650023|NCT00106028|183192276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253|TWO_SIDED|95.0|0.31|0.922||All Non-Vertebral Fractures|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
91650024|NCT00106028|183192276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487||||0.0501|TWO_SIDED|95.0|0.25|0.95||Long Bone Non-Vertebral Fracture|Cox Proportional Hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.950|0.250|0.0501
91650025|NCT00106028|183192276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2141|TWO_SIDED|95.0|0.262|1.41||Other Non-Vertebral Fracture|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.410|0.262|0.2141
91650026|NCT00106028|183192277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416||95.0|0.348|0.98||All Fractures|Wald test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
91650027|NCT00106028|183192277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416|TWO_SIDED|95.0|0.348|0.98||Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
91650028|NCT00106028|183192277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||0.0799|TWO_SIDED|95.0|0.274|1.076||Long Bone Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.076|0.274|0.0799
91650029|NCT00106028|183192277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.682|TWO_SIDED|95.0|0.304|1.532||Other Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.532|0.304|0.682
91650030|NCT00106028|183192278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.678||||0.0318||95.0|-22.325|-1.031|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-1.031|-22.325|0.0318
91650031|NCT00106028|183192279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.9907|TWO_SIDED|95.0|-11.401|11.536|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.536|-11.401|0.9907
91522599|NCT01091948|182920226|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89||||0.58|TWO_SIDED|95.0|0.58|1.35|||ANCOVA||The mean intubation difficulty score was tested after logarithmic transformation, and then back transformed for the estimated treatment effect.|||1.35|0.58|0.58
91600263|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.55|7.58||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||7.58|2.55|<0.0001
91790489|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.164||0.663|TWO_SIDED|95.0|-0.394|0.251||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.251|-0.394|0.663
91522600|NCT01091948|182920227|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.15|TWO_SIDED|95.0|0.95|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.95|0.15
91600264|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.81|||<|0.0001|TWO_SIDED|95.0|3.15|10.74||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.74|3.15|<0.0001
91600265|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.0001|TWO_SIDED|95.0|3.25|11.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||11.73|3.25|<0.0001
91600266|NCT00848354|183091911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.45|||<|0.0001|TWO_SIDED|95.0|3.67|11.33||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.33|3.67|<0.0001
91600267|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.09||||0.0349|TWO_SIDED|95.0|1.05|9.13||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||9.13|1.05|0.0349
91600268|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|||<|0.0001|TWO_SIDED|95.0|1.98|7.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.60|1.98|<0.0001
91600269|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.1|5.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.88|2.10|<0.0001
91600270|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.02|5.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.06|2.02|<0.0001
91600271|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.78|6.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.96|2.78|<0.0001
91600272|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|6.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.90|2.80|<0.0001
91600273|NCT00848354|183091913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.13|||<|0.0001|TWO_SIDED|95.0|3.82|9.85||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.85|3.82|<0.0001
91522601|NCT01091948|182920228|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.67||||0.57|TWO_SIDED|95.0|0.28|10.2|||Cochran-Mantel-Haenszel|||||10.2|0.28|0.57
91522602|NCT01091948|182920229|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01||||0.79|TWO_SIDED|95.0|0.93|1.09|||Cochran-Mantel-Haenszel|||||1.09|0.93|0.79
91600274|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.25|||<|0.0001|TWO_SIDED|95.0|2.74|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.60|2.74|<0.0001
91600275|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.94|7.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.18|2.94|<0.0001
91600276|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.0001|TWO_SIDED|95.0|3.15|8.61||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.61|3.15|<0.0001
91600277|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.77|||<|0.0001|TWO_SIDED|95.0|3.36|9.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.93|3.36|<0.0001
91600278|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|3.91|13.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.09|3.91|<0.0001
91600279|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.43|||<|0.0001|TWO_SIDED|95.0|4.5|15.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.80|4.50|<0.0001
91600280|NCT00848354|183091915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001|TWO_SIDED|95.0|3.5|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||10.47|3.50|<0.0001
91600281|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
91600282|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
91785197|NCT02123251|183450653|SUPERIORITY_OR_OTHER||||||>|0.05|||||||standard diffs-in-diffs model|||A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.||||>0.05
91785198|NCT02123251|183450654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6403|STANDARD_ERROR_OF_MEAN|0.3148||0.042|TWO_SIDED|95.0|0.0233|1.2572|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.||1.2572|0.0233|0.0420
91785199|NCT02123251|183450655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1188|STANDARD_ERROR_OF_MEAN|1.031||0.0399|TWO_SIDED|95.0|0.0981|4.1395|||Generalized Estimating Equation Model|The effect of age and gender is adjusted in the GEE model.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.||4.1395|0.0981|.0399
91785200|NCT00926029|183450697|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91785201|NCT00926029|183450698|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91785202|NCT02250703|183450759|SUPERIORITY_OR_OTHER|||||||0.025||||||Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)|Chi-squared|||A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power||||0.025
91650032|NCT00106028|183192280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.686||||0.3826|TWO_SIDED|95.0|-15.276|5.903|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||5.903|-15.276|0.3826
91785203|NCT02250703|183450760|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91785204|NCT02250703|183450761|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91785205|NCT02250703|183450762|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91785206|NCT01776307|183450780|OTHER|Descriptive analysis for investigational arms; no comparator analysis|||||||||||||||||The exact 95% confidence interval is based on the Clopper-Pearson method.|||
91785207|NCT01776307|183450781|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
91785208|NCT01776307|183450782|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
91785209|NCT00567255|183450795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.56|||<|0.001||95.0|-5.19|-3.93|||ANCOVA|||||-3.93|-5.19|<0.001
91785210|NCT00567255|183450796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.16|||<|0.001|TWO_SIDED|95.0|-5.95|-4.38|||ANCOVA|||||-4.38|-5.95|<0.001
91785211|NCT00567255|183450797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.61|||<|0.001||95.0|4.95|8.84|||Regression, Logistic|||||8.84|4.95|<0.001
91785212|NCT00567255|183450798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|4.05|7.47|||Regression, Logistic|||||7.47|4.05|<0.001
91785213|NCT00567255|183450799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.001|TWO_SIDED|95.0|3.6|7.98|||Regression, Logistic|||||7.98|3.60|<0.001
91600283|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
91600284|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
91600285|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
91600286|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
91600287|NCT00848354|183091917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
91600288|NCT00848354|183091919|SUPERIORITY_OR_OTHER|||||||0.3054||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||||0.3054
91600289|NCT00848354|183091919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.4044|TWO_SIDED|95.0|0.58|7.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.53|0.58|0.4044
91600290|NCT00848354|183091919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0388|TWO_SIDED|95.0|1.02|6.26||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.26|1.02|0.0388
91600291|NCT00848354|183091919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89||||0.0059|TWO_SIDED|95.0|1.31|6.34||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.34|1.31|0.0059
91650033|NCT00106028|183192281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.629|||<|0.0001||95.0|-38.089|-15.169|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-15.169|-38.089|<0.0001
91600292|NCT00848354|183091919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001|TWO_SIDED|95.0|1.99|9.29||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.29|1.99|<0.0001
91650034|NCT00106028|183192282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.04||||0.3075|TWO_SIDED|95.0|-8.433|26.512|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||26.512|-8.433|0.3075
91710816|NCT01100723|183314036|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||<0.05
91785214|NCT00567255|183450800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|95.0|-4.33|-2.53|||ANCOVA|||||-2.53|-4.33|<0.001
91600293|NCT00848354|183091919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.88|12.24||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||12.24|2.88|<0.0001
91600294|NCT00848354|183091919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.18|||<|0.0001|TWO_SIDED|95.0|3.61|23.32||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||23.32|3.61|<0.0001
91600295|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
91600296|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
91600297|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
91600298|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
91600299|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
91600300|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
91522603|NCT01091948|182920230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.45|2.76|||Regression, Logistic|proportional odds logistic regression model||||2.76|0.45|0.82
91522604|NCT01542957|182920250|SUPERIORITY_OR_OTHER||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.69||0.6|TWO_SIDED|95.0|-3.35|1.43|||Mixed Models Analysis|||||1.43|-3.35|0.60
91522605|NCT01542957|182920251|SUPERIORITY_OR_OTHER||Slope|1.27|STANDARD_ERROR_OF_MEAN|0.53||0.21|TWO_SIDED|95.0|-0.71|3.25|||Mixed Models Analysis|||||3.25|-0.71|0.21
91522606|NCT01542957|182920252|SUPERIORITY_OR_OTHER||Slope|-0.01||||0.84|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.84
91522607|NCT05805657|182920273|SUPERIORITY||Time by treatment interaction coeff.|-7.16|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.||||<0.001
91522608|NCT05805657|182920273|SUPERIORITY||Time by treatment interaction coeff.|2.22||||0.52|TWO_SIDED|||||Standard TranS-C versus Adapted TranS-C on change in sleep disturbance from pre to post.|Intent-to-treat, multilevel modeling|||||||0.52
91522609|NCT05805657|182920273|SUPERIORITY||Coefficient|-10.89||||0.02|TWO_SIDED||||||Regression, Linear|||Acceptability of intervention measure (AIM) predicting sleep disturbance.||||0.02
91522610|NCT05805657|182920273|SUPERIORITY||Coefficient|-6.26||||0.04|TWO_SIDED||||||Regression, Linear|||Appropriateness of intervention measure (IAM) predicting sleep disturbance.||||0.04
91522611|NCT05805657|182920273|SUPERIORITY||Coefficient|-10.37||||0.001|TWO_SIDED||||||Regression, Linear|||Feasibility of intervention measure (FIM) predicting sleep disturbance.||||0.001
91522612|NCT05805657|182920275|SUPERIORITY||Time by treatment interaction coeff.|-6.44||||0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep- related impairment from pre to post.||||0.001
91522613|NCT05805657|182920275|SUPERIORITY||Time by treatment interaction coeff.|1.36||||0.72|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Standard TranS-C versus Adapted TranS-C on change in sleep-related impairment from pre to post.||||0.72
91522614|NCT05805657|182920275|SUPERIORITY||Coefficient|-3.9||||0.3|TWO_SIDED||||||Regression, Linear|||Acceptability of intervention measure (AIM) predicting sleep-related impairment.||||0.30
91522615|NCT05805657|182920275|SUPERIORITY||Coefficient|0.79||||0.78|TWO_SIDED||||||Regression, Linear|||Appropriateness of intervention measure (IAM) predicting sleep-related impairment.||||0.78
91522616|NCT05805657|182920275|SUPERIORITY||Coefficient|-4.45||||0.15|TWO_SIDED||||||Regression, Linear|||Feasibility of intervention measure (FIM) predicting sleep-related impairment.||||0.15
91600301|NCT00848354|183091921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
91522617|NCT05805657|182920276|SUPERIORITY||Time by treatment interaction coeff.|0.55||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.||||0.09
91522618|NCT05805657|182920276|SUPERIORITY||Time by treatment interaction coeff.|1.05||||0.11|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Standard TranS-C versus Adapted TranS-C on change in sleep health from pre to post.||||0.11
91522619|NCT05805657|182920276|SUPERIORITY||Coefficient|0.45||||0.59|TWO_SIDED||||||Regression, Linear|||Acceptability of intervention measure (AIM) predicting sleep health.||||0.59
91522620|NCT05805657|182920276|SUPERIORITY||Coefficient|0.72||||0.14|TWO_SIDED||||||Regression, Linear|||Appropriateness of intervention measure (IAM) predicting sleep health.||||0.14
91522621|NCT05805657|182920276|SUPERIORITY||Coefficient|0.89||||0.06|TWO_SIDED||||||Regression, Linear|||Feasibility of intervention measure (FIM) predicting sleep health.||||0.06
91522622|NCT05805657|182920277|SUPERIORITY||Time by treatment interaction coeff.|-4.33||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.||||0.002
91522623|NCT05805657|182920277|SUPERIORITY||Coefficient of indirect effect|-2.2||||0.002|TWO_SIDED|95.0|-3.57|-0.83|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.83|-3.57|0.002
91600302|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.07||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||7.07|2.90|<0.0001
91600303|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.36|6.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.80|2.36|<0.0001
91600304|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.0001|TWO_SIDED|95.0|2.82|9.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||9.72|2.82|<0.0001
91600305|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.25|||<|0.0001|TWO_SIDED|95.0|2.63|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||10.47|2.63|<0.0001
91600306|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.0001|TWO_SIDED|95.0|3.16|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|3.16|<0.0001
91600307|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.38|||<|0.0001|TWO_SIDED|95.0|3.86|18.17||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||18.17|3.86|<0.0001
91600308|NCT00848354|183091923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.94|15.62||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.62|3.94|<0.0001
91600309|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.35|5.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.73|2.35|<0.0001
91600310|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|3.0|7.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.22|3.00|<0.0001
91600311|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.05|8.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.06|3.05|<0.0001
91600312|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.0001|TWO_SIDED|95.0|3.18|8.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||8.96|3.18|<0.0001
91600313|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.7|||<|0.0001|TWO_SIDED|95.0|3.23|10.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.06|3.23|<0.0001
91600314|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88|||<|0.0001|TWO_SIDED|95.0|4.37|14.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||14.20|4.37|<0.0001
91600315|NCT00848354|183091925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.73|||<|0.0001|TWO_SIDED|95.0|3.4|9.65||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.65|3.40|<0.0001
91600316|NCT00848354|183091927|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91785215|NCT00567255|183450801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.59|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||ANCOVA|||||3.57|1.61|<0.001
91600317|NCT00848354|183091929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600318|NCT00848354|183091931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600319|NCT00848354|183091933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600320|NCT00848354|183091935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
91600321|NCT00848354|183091935|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||0.0007
91600322|NCT00848354|183091935|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0009
91600323|NCT00848354|183091935|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
91600324|NCT00848354|183091935|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0005
91710817|NCT01100723|183314037|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
91785216|NCT00567255|183450802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.96||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
91600325|NCT00848354|183091935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
91600326|NCT00848354|183091935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91600327|NCT00848354|183091937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600328|NCT00848354|183091939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600329|NCT00848354|183091941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600330|NCT00848354|183091943|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.1975
91600331|NCT00848354|183091944|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.0044
91650035|NCT00106028|183192283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.039||||0.3998|TWO_SIDED|95.0|-16.849|6.772|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.772|-16.849|0.3998
91600332|NCT00848354|183091945|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
91600333|NCT00848354|183091947|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
91600334|NCT00848354|183091947|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||<0.0001
91600335|NCT00848354|183091947|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0002
91600336|NCT00848354|183091947|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
91650036|NCT00106028|183192284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.352||||0.1592||95.0|-0.845|0.14|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.140|-0.845|0.1592
91785217|NCT00567255|183450803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.77|||<|0.001|TWO_SIDED|95.0|2.46|5.09|||ANCOVA|||||5.09|2.46|<0.001
91785218|NCT00567255|183450804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.24||||0.091|TWO_SIDED||||||ANCOVA|||||||0.091
91785219|NCT00567255|183450805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.64|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
91785220|NCT00567255|183450806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.6|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-1.60|
91650037|NCT00106028|183192285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127||||0.2917||95.0|-0.111|0.365|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.365|-0.111|0.2917
91600337|NCT00848354|183091947|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0001
91600338|NCT00848354|183091947|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
91650038|NCT00106028|183192286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007||||0.9622||95.0|-0.304|0.319|||ANOVA|LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.319|-0.304|0.9622
91650039|NCT00106028|183192287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009||||0.9596|TWO_SIDED|95.0|-0.336|0.354|||ANOVA|LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.354|-0.336|0.9596
91650040|NCT00106028|183192288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.107||||0.34||95.0|-0.114|0.328|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.328|-0.114|0.3400
91710818|NCT01100723|183314038|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
91600339|NCT00848354|183091947|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0021
91600340|NCT00848354|183091948|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0001
91600341|NCT00848354|183091948|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
91650041|NCT00106028|183192289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.029||||0.6218|TWO_SIDED|95.0|-0.084|0.142|||ANOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.142|-0.084|0.6218
91785221|NCT00567255|183450807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.29|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
91785222|NCT00567255|183450808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.23|||||TWO_SIDED|95.0|-9.92|-4.54||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-4.54|-9.92|
91785223|NCT00567255|183450809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|||||TWO_SIDED|95.0|-7.29|-1.44||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.44|-7.29|
91785224|NCT00567255|183450810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.7|1.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.30|-0.70|
91600342|NCT00848354|183091948|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0003
91600343|NCT00848354|183091950|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
91600344|NCT00848354|183091950|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0264
91600345|NCT00848354|183091950|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
91600346|NCT00848354|183091952|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0005
91600347|NCT00848354|183091952|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
91600348|NCT00848354|183091952|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91600349|NCT00848354|183091954|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).||||<0.0001
91600350|NCT00848354|183091955|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0061
91600351|NCT00848354|183091955|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0730
91600352|NCT00848354|183091955|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91710819|NCT01100723|183314039|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
91785225|NCT00567255|183450811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87|||||TWO_SIDED|95.0|0.16|1.58||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.58|0.16|
91600353|NCT00848354|183091956|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0066
91600354|NCT00848354|183091956|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0036
91600355|NCT00848354|183091956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91600356|NCT00848354|183091957|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
91600357|NCT00848354|183091957|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0013
91785226|NCT00567255|183450812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.49|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.49|
91650042|NCT00479401|183192319|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority hypothesis comparing pramipexole ER to pramipexole IR was to be tested using a non-inferiority margin of -3 points. The primary efficacy endpoint in UPDRS part II+III was the change from baseline (week 0) to week 33 on the UPDRS Parts II+III score combined. The statistical model was analysis of covariance, controlling for baseline UPDRS Part II+III. Fixed terms in the model were treatment, country, and UPDRS Part II+III score at baseline.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.2|1.7|||ANCOVA|Null hypothesis was tested using an analysis of covariance model with α = 0.05 in full analysis set with last observation carried forward.|PPX ER non-inferior to PPX IR, if the lower limit of the confidence interval for the difference is higher than the non-inferiority margin of -3|A non-inferiority hypothesis (H0: μER - μIR \< -3 vs. H1: μER - μIR ≥ -3) comparing pramipexole ER to pramipexole IR was tested using a non-inferiority margin of -3 points.||1.7|-2.2|
91650043|NCT01504867|183192335|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wald|This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.||The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%||||0.53
91650044|NCT01504867|183192336|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
91650045|NCT01504867|183192337|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
91650046|NCT01504867|183192338|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||||||0.23
91650047|NCT01504867|183192339|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91650048|NCT01504867|183192340|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
91650049|NCT01504867|183192341|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91650050|NCT02257632|183192366|SUPERIORITY||Mean Difference (Final Values)|-14.98|||<|0.0001|TWO_SIDED|95.0|-19.64|-10.32||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all other patients|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-10.32|-19.64|<0.0001
91650051|NCT02257632|183192367|SUPERIORITY||Mean Difference (Final Values)|-11.46|||<|0.0001|TWO_SIDED|95.0|-15.98|-6.94||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all the patients with values|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-6.94|-15.98|< 0.0001
91650052|NCT01133821|183192409|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||time effect for HRSD-17||||<0.0001
91650053|NCT01133821|183192410|SUPERIORITY||||||>|0.05|||||||Regression, Linear|Adjusted for baseline scores||||||>0.05
91650054|NCT00434161|183192411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.679||||0.188|TWO_SIDED|97.5|0.351|1.313||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||1.313|0.351|0.188
91650055|NCT00434161|183192411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.242||||0.468|TWO_SIDED|97.5|0.635|2.431||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||2.431|0.635|0.468
91650056|NCT00434161|183192412|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.262||||0.245|TWO_SIDED|97.5|-4.303|30.828||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||30.828|-4.303|0.245
91650057|NCT00434161|183192412|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.014||||0.806|TWO_SIDED|97.5|-20.519|16.491||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||16.491|-20.519|0.806
91650058|NCT00434161|183192413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.409|STANDARD_DEVIATION|6.82||0.095|TWO_SIDED|97.5|0.07|4.748||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||4.748|0.070|0.095
91600358|NCT00848354|183091957|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
91600359|NCT00848354|183091958|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0021
91600360|NCT00848354|183091958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
91600361|NCT00848354|183091958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91600362|NCT00848354|183091959|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0062
91600363|NCT00848354|183091959|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0007
91600364|NCT00848354|183091959|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91600365|NCT00848354|183091960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
91600366|NCT00848354|183091960|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0073
91600367|NCT00848354|183091960|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
91650059|NCT00434161|183192413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_DEVIATION|6.13||0.806|TWO_SIDED|97.5|-2.575|2.15||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||2.150|-2.575|0.806
91785227|NCT00567255|183450813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.56|0.52||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.52|-0.56|
91600368|NCT00915343|183091961|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862||Comparison of log S-cortisol AUC between OD and TID regimens was adjusted for both period effect and subject effect using generalized linear model (GLM) in statistical analysis system (SAS).|ANOVA||The quotient was defined as AUC0-24h for OD treatment divided by AUC0-24h for TID treatment.|||0.862|0.753|<0.0001
91600369|NCT00915343|183091962|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-111.989|||<|0.0001|TWO_SIDED|95.0|-133.98|89.999|||Fisher's non-parametric permutation test|||||89.999|-133.980|<0.0001
91600370|NCT00915343|183091963|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|110.417||||0.0357|TWO_SIDED|95.0|16.755|204.078|||Fisher's non-parametric permutation test|||||204.078|16.755|0.0357
91600371|NCT00915343|183091964|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-38.076|||<|0.0001|TWO_SIDED|95.0|-50.276|25.876|||Fisher's non-parametric permutation test|||||25.876|-50.276|<0.0001
91600372|NCT00915343|183091965|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-65.782||||0.0033|TWO_SIDED|95.0|-109.201|22.362|||Fisher's non-parametric permutation test|||||22.362|-109.201|0.0033
91600373|NCT00915343|183091966|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-148.015|||<|0.0001|TWO_SIDED|95.0|-189.469|-106.561|||Fisher's non-parametric permutation test|||||-106.561|-189.469|<0.0001
91600374|NCT00915343|183091967|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-108.306|||<|0.0001|TWO_SIDED|95.0|-140.193|-76.42|||Fisher's non-parametric permutation test|||||-76.420|-140.193|<0.0001
91600375|NCT00915343|183091968|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.27||||0.0214|TWO_SIDED|95.0|0.028|0.512|||Fisher's non-parametric permutation test|||||0.512|0.028|0.0214
91600376|NCT00915343|183091969|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-1.042||||0.0714|TWO_SIDED|95.0|-2.098|0.015|||Fisher's non-parametric permutation test|||||0.015|-2.098|0.0714
91600377|NCT00915343|183091970|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.007||||0.6687|TWO_SIDED|95.0|-0.038|0.024|||Fisher's non-parametric permutation test|||||0.024|-0.038|0.6687
91600378|NCT00915343|183091971|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.049||||0.028|TWO_SIDED|95.0|0.006|0.093|||Fisher's non-parametric permutation test|||||0.093|0.006|0.0280
91600379|NCT00915343|183091972|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|5.509||||0.0003|TWO_SIDED|95.0|0.751|10.268|||Fisher's non-parametric permutation test|||||10.268|0.751|0.0003
91600380|NCT00915343|183091973|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-20.533|-7.067|||Fisher's non-parametric permutation test|||||-7.067|-20.533|<0.0001
91650060|NCT00434161|183192414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.436||||0.142|TWO_SIDED|97.5|-1.542|32.415||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||32.415|-1.542|0.142
91650061|NCT00434161|183192414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.331||||0.806|TWO_SIDED|97.5|-11.82|22.482||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||22.482|-11.820|0.806
91650062|NCT00434161|183192415|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.88|||||TWO_SIDED|95.0|-21.669|33.43||According to statistical analysis plan it was not planned to calculate any P-Value.||||||33.43|-21.669|
91600381|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.064||||0.0002|TWO_SIDED|95.0|1.032|1.097|||ANOVA||The quotient was defined as AUC0-4h for OD treatment divided by AUC0-4h for TID treatment.|AUC0-4h||1.097|1.032|0.0002
91600382|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.617|||<|0.0001|TWO_SIDED|95.0|0.563|0.675|||ANOVA||The quotient was defined as AUC4-12h for OD treatment divided by AUC4-12h for TID treatment.|AUC4-12h||0.675|0.563|<0.0001
91600383|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.472|||<|0.0001|TWO_SIDED|95.0|0.424|0.525|||ANOVA||The quotient was defined as AUC6-12h for OD treatment divided by AUC6-12h for TID treatment.|AUC6-12h||0.525|0.424|<0.0001
91600384|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.588||||0.0003|TWO_SIDED|95.0|0.446|0.775|||ANOVA||The quotient was defined as AUC12-24h for OD treatment divided by AUC12-24h for TID treatment.|AUC12-24h||0.775|0.446|0.0003
91600385|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.894|||<|0.0001|TWO_SIDED|95.0|0.856|0.935|||ANOVA||The quotient was defined as AUC0-10h for OD treatment divided by AUC0-10h for TID treatment.|AUC0-10h||0.935|0.856|<0.0001
91650063|NCT00434161|183192417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023|||||TWO_SIDED|95.0|-0.134|0.181||||||||0.181|-0.134|
91600386|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.695|||<|0.0001|TWO_SIDED|95.0|0.632|0.765|||ANOVA||The quotient was defined as AUC4-10h for OD treatment divided by AUC4-10h for TID treatment.|AUC4-10h||0.765|0.632|<0.0001
91600387|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.54|||<|0.0001|TWO_SIDED|95.0|0.482|0.605|||ANOVA||The quotient was defined as AUC6-10h for OD treatment divided by AUC6-10h for TID treatment.|AUC6-10h||0.605|0.482|<0.0001
91600388|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.412|||<|0.0001|TWO_SIDED|95.0|0.338|0.504|||ANOVA||The quotient was defined as AUC10-24h for OD treatment divided by AUC10-24h for TID treatment.|AUC10-24h||0.504|0.338|<0.0001
91600389|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.776|||<|0.0001|TWO_SIDED|95.0|0.714|0.843|||ANOVA||The quotient was defined as AUC(0-inf) for OD treatment divided by AUC(0-inf) for TID treatment.|AUC(0-inf)||0.843|0.714|<0.0001
91600390|NCT00915343|183091974|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.069||||0.877|TWO_SIDED|95.0|0.453|2.521|||ANOVA||The quotient was defined as AUC(24h-inf) for OD treatment divided by AUC(24h-inf) for TID treatment.|AUC(24h-inf)||2.521|0.453|0.8770
91600391|NCT00915343|183091975|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862|||ANOVA||The quotient was defined as AUCtau for OD treatment divided by AUCtau for TID treatment.|||0.862|0.753|<0.0001
91600392|NCT00915343|183091976|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.79|||<|0.0001|TWO_SIDED|95.0|0.734|0.851|||ANOVA||The quotient was defined as AUCtau/dose for OD treatment divided by AUCtau/dose for TID treatment.|||0.851|0.734|<0.0001
91600393|NCT00915343|183091977|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.785|||<|0.0001|TWO_SIDED|95.0|0.741|0.831|||ANOVA||The quotient was defined as AUC0-24h/dose for OD treatment divided by AUC0-24h/dose for TID treatment.|||0.831|0.741|<0.0001
91600394|NCT00915343|183091978|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.885|||<|0.0001|TWO_SIDED|95.0|0.844|0.926|||ANOVA||The quotient was defined as AUC0-10h/dose for OD treatment divided by AUC0-10h/dose for TID treatment.|||0.926|0.844|<0.0001
91650064|NCT00434161|183192418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||||TWO_SIDED|95.0|-0.138|0.26||||||||0.260|-0.138|
91650065|NCT00434161|183192419|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.689|||||TWO_SIDED|95.0|-21.641|14.264||||||||14.264|-21.641|
91650066|NCT00434161|183192420|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.951|||||TWO_SIDED|95.0|-0.679|12.58||||||||12.580|-0.679|
91650067|NCT00434161|183192422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.192|TWO_SIDED|95.0|0.33|1.26|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.26|0.33|0.192
91600395|NCT00915343|183091979|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.053||||0.002|TWO_SIDED|95.0|1.02|1.086|||ANOVA||The quotient was defined as AUC0-4h/dose for OD treatment divided by AUC0-4h/dose for TID treatment.|||1.086|1.020|0.0020
91600396|NCT00915343|183091980|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|<0.0001
91600397|NCT00915343|183091981|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.002|-0.001|||Fisher's non-parametric permutation test|||||-0.001|-0.002|<0.0001
91600398|NCT00915343|183091982|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.055||||0.7827|TWO_SIDED|95.0|-0.444|0.334|||Fisher's non-parametric permutation test|||||0.334|-0.444|0.7827
91600399|NCT00915343|183091983|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001||||0.0015|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|0.0015
91650068|NCT00434161|183192423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.417|||||TWO_SIDED|95.0|-11.086|45.919||||||||45.919|-11.086|
91710820|NCT01100723|183314040|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
91710821|NCT03665077|183314051|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684
91785228|NCT00567255|183450814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.98|0.02||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.02|-0.98|
91785229|NCT03530124|183450835|SUPERIORITY|The number of infants with ≥1 apneic event for each group and compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group (\< 28 weeks versus ≥ 28 weeks) to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.7||||0.0104|TWO_SIDED|95.0|1.27|5.73|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the primary objective.|||5.73|1.27|0.0104
91785230|NCT03530124|183450836|OTHER|The number of apnea events were compared using a linear regression model (assuming a Poisson distribution) with study site and gestational age group covariates to control for the randomization blocks.||||||0.11|||||||Regression, Linear|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.11
91785231|NCT03530124|183450837|OTHER|Average duration of apnea episodes between groups were compared using a mixed effects model with a random intercept for each infant with one or more events and study site and gestational age group as covariates to control for the randomization blocks.||||||0.36|||||||Mixed Effects Model|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.36
91785232|NCT03530124|183450838|SUPERIORITY|The proportion of infants requiring an increase in respiratory support for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.07||||0.3555|TWO_SIDED|95.0|0.59|7.23|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|||7.23|0.59|0.3555
91785233|NCT03530124|183450839|SUPERIORITY|The proportion of infants with ≥1 cardiorespiratory event using a Mantel-Haenszel statistic in at the two-sided alpha 0.05 level and corresponding 95% confidence interval.|Odds Ratio (OR)|0.89||||1|TWO_SIDED|95.0|0.29|2.77|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|Only Duke University had viable monitoring data to analyze this compound outcome objective.||2.77|0.29|1.0000
91785234|NCT03530124|183450840|SUPERIORITY||Odds Ratio (OR)|1.93||||1|TWO_SIDED|95.0|0.17|21.63|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|The proportion of infants requiring positive pressure ventilation for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea during the 48-hour monitoring period.||21.63|0.17|1.0000
91785235|NCT02791763|183450859|NON_INFERIORITY|Non-inferiority was to be established as the lower limit of the 95% confidence interval (CI) for the treatment difference was greater than the pre-specified non-inferiority margin (-1.0 g/dL).|Median Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.07|0.28||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|||0.28|-0.07|<.0001
91785236|NCT02791763|183450860|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
91785237|NCT02791763|183450861|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
91785238|NCT02878798|183450984|OTHER|Non-inferiority and superiority tests were completed|Slope|0.2105|||||ONE_SIDED|95.0|-0.4328||||||||||-0.4328|
91785239|NCT02878798|183450985|OTHER|Non-inferiority and superiority tests were done|Slope|-1.5219|||||ONE_SIDED|95.0||1.1933||||||||1.1933||
91785240|NCT02878798|183450986|SUPERIORITY||Slope|-0.02322|||||TWO_SIDED|95.0|-0.6337|0.5872|||Mixed Models Analysis|||||0.5872|-0.6337|
91785241|NCT02878798|183450987|SUPERIORITY||Slope|-0.168||||0.261|TWO_SIDED|95.0|-0.4612|0.1253|||Mixed Models Analysis|||||0.1253|-0.4612|0.261
91785242|NCT02878798|183450988|SUPERIORITY||Slope|-0.061||||0.9007|TWO_SIDED|95.0|-1.0213|0.8992|||Mixed Models Analysis|||||0.8992|-1.0213|0.9007
91785243|NCT02878798|183450989|SUPERIORITY||Slope|0.0106||||0.8174|TWO_SIDED|95.0|-0.0793|0.1005|||Hurdle model|||||0.1005|-0.0793|0.8174
91785244|NCT02878798|183450990|SUPERIORITY||Slope|-0.7394||||0.0233|TWO_SIDED|95.0|-1.3775|-0.1013|||Mixed Models Analysis|||||-0.1013|-1.3775|0.0233
91785245|NCT02878798|183450991|SUPERIORITY||Slope|-0.1328||||0.7586|TWO_SIDED|95.0|-0.982|0.7164|||Mixed Models Analysis|||||0.7164|-0.982|0.7586
91785246|NCT02878798|183450992|SUPERIORITY||Slope|-0.0021||||0.9604|TWO_SIDED|95.0|-0.084|0.0799|||Mixed Models Analysis|||||0.0799|-0.084|0.9604
91785247|NCT02878798|183450993|SUPERIORITY||Slope|-0.0396||||0.2365|TWO_SIDED|95.0|-0.1053|0.0261|||Mixed Models Analysis|||||0.0261|-0.1053|0.2365
91785248|NCT02878798|183450994|SUPERIORITY||Slope|2.3848||||0.5813|TWO_SIDED|95.0|-6.1336|10.9032|||Mixed Models Analysis|||||10.9032|-6.1336|0.5813
91650069|NCT00434161|183192424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.236|TWO_SIDED|95.0|0.55|1.16|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.16|0.55|0.236
91650070|NCT00434161|183192425|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.84||||0.372|TWO_SIDED|95.0|0.58|1.23|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.23|0.58|0.372
91650071|NCT03342898|183192427|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 120. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the seroprotection rate difference (Group 1 - Group 3) was less than 5%.|Seroprotection Rate Difference|0.4|||||TWO_SIDED|95.0|-1.85|2.69|||||The Newcombe score method was used to compute the 95% CI of the seroprotection rate difference.|||2.69|-1.85|
91650072|NCT03342898|183192428|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.22|||||Analysis of variance (ANOVA) model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-1||2.22|1.19|
91650073|NCT03342898|183192428|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|1.03|1.75|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-2||1.75|1.03|
91650074|NCT03342898|183192428|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|0.99|1.61|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-3||1.61|0.99|
91600400|NCT00915343|183091984|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|6.098|||<|0.0001|TWO_SIDED|95.0|2.94|12.646|||ANOVA||The quotient was defined as AUC Extrapolation for OD treatment divided by AUC Extrapolation for TID treatment.|||12.646|2.940|<0.0001
91600401|NCT00915343|183091985|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|33.532||||0.0396|TWO_SIDED|95.0|1.734|65.329|||Fisher's non-parametric permutation test|||||65.329|1.734|0.0396
91600402|NCT00915343|183091986|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.08||||0.1032|TWO_SIDED|95.0|-0.017|0.177|||Fisher's non-parametric permutation test|||||0.177|-0.017|0.1032
91600403|NCT00915343|183091987|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.078||||0.3767|TWO_SIDED|95.0|-0.25|0.094|||Fisher's test|Fisher's non||Patient||0.094|-0.250|0.3767
91600404|NCT00915343|183091987|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.064||||0.4625|TWO_SIDED|95.0|-0.235|0.107|||Fisher's test|Fisher's non||Investigator||0.107|-0.235|0.4625
91600405|NCT00915343|183091988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6072|TWO_SIDED||||||Sign test|||Patient||||0.6072
91600406|NCT00915343|183091988|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Sign test|||Investigator||||1.0000
91650075|NCT03342898|183192428|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.46|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-4||1.46|0.89|
91785249|NCT02878798|183450995|SUPERIORITY||Slope|-1.0547||||0.4092|TWO_SIDED|95.0|-3.5705|1.4611|||Mixed Models Analysis|||||1.4611|-3.5705|0.4092
91785250|NCT02762370|183450996|SUPERIORITY|||||||0.0452|||||||t-test, 2 sided|||||||0.0452
91785251|NCT01708902|183451023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0587|TWO_SIDED|95.0|-0.45|0.01|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||0.01|-0.45|0.0587
91785252|NCT01708902|183451023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.23|-0.78|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.78|-1.23|<0.0001
91785253|NCT01708902|183451023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.73|-0.29|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.29|-0.73|<0.0001
91790490|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91650076|NCT03342898|183192432|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 30. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 1/Group 3) was less than 2.0.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.26|||||ANOVA model was used for analyses, including the log-transformed value of titer as the dependent variable and trial group as a factor.|||1.26|0.77|
91650077|NCT00461500|183192486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.23|STANDARD_ERROR_OF_MEAN|17.6||0.683||95.0|-27.96|42.43|||ANCOVA||mean difference = drug SFC 100 minus FP 100|||42.43|-27.96|0.683
91650078|NCT01144663|183192517|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|0.01|||||TWO_SIDED|95.0|-1.17|1.2||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference \[Nimenrix 3 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||1.2|-1.17|
91650079|NCT01144663|183192517|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percenttage|-0.43|||||TWO_SIDED|95.0|-1.57|0.4||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 3 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.4|-1.57|
91650080|NCT01144663|183192517|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-2.45|0.43||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.43|-2.45|
91650081|NCT01144663|183192517|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-1.32|||||TWO_SIDED|95.0|-2.84|-0.48||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||-0.48|-2.84|
91709433|NCT04633291|183311478|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard Male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.58||The threshold for statistical significance was set at 0.05|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.58|-0.50|0.88
91709434|NCT04633291|183311479|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.14||||0.62|TWO_SIDED|95.0|-0.72|0.44||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.44|-0.72|0.62
91710822|NCT03665077|183314052|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02
91710823|NCT03665077|183314053|OTHER|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058
91785254|NCT01708902|183451023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.09|-0.64|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.64|-1.09|<0.0001
91785255|NCT01708902|183451024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|STANDARD_ERROR_OF_MEAN|0.487||0.0771|TWO_SIDED|95.0|0.946|2.961|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.961|0.946|0.0771
91650082|NCT03081767|183192565|OTHER||||||<|1e-07||||||Actual P-Value = 3.89597E-42. A P-value of \<0.05 was considered significant.|t-test, 2 sided|||||||<0.0000001
91600407|NCT00915343|183091989|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.6||||0.3332|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.3332
91600408|NCT00915343|183091989|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.9||||0.3405|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3405
91600409|NCT00915343|183091990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8418|TWO_SIDED||||||Wilcoxon Signed Rank|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.8418
91600410|NCT00915343|183091990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.355|TWO_SIDED||||||Wilcoxon Signed Rank test|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3550
91600411|NCT00915343|183091991|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-2.9||||0.0823|TWO_SIDED||||||Fisher's|Fisher's non-parametric two-sample permutation test||||||0.0823
91600412|NCT00915343|183091992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5982|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5982
91600413|NCT00915343|183091993|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|2.3||||0.0632|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||||||0.0632
91600414|NCT00915343|183091994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8676|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.8676
91600415|NCT00915343|183091995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9700
91600416|NCT00915343|183091996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.2624
91600417|NCT00915343|183091997|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|1.28|||||TWO_SIDED|||||||||||||
91785256|NCT01708902|183451024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.489|STANDARD_ERROR_OF_MEAN|1.543|<|0.0001|TWO_SIDED|95.0|3.164|9.522|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||9.522|3.164|<0.0001
91600418|NCT00915343|183091999|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Sign test|||||||<0.0001
91600419|NCT00915343|183092000|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-272.3||||0.0034|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0034
91785257|NCT01708902|183451024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.829|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|1.678|4.767|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.767|1.678|<0.0001
91785258|NCT01708902|183451024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|2.259|6.454|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.454|2.259|<0.0001
91785259|NCT01708902|183451025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.169|STANDARD_ERROR_OF_MEAN|1.565||0.0001|TWO_SIDED|95.0|1.997|8.701|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||8.701|1.997|0.0001
91785260|NCT01708902|183451026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661|STANDARD_ERROR_OF_MEAN|0.426||0.048|TWO_SIDED|95.0|1.004|2.746|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.746|1.004|0.0480
91785261|NCT01708902|183451026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.923|STANDARD_ERROR_OF_MEAN|1.632|<|0.0001|TWO_SIDED|95.0|3.452|10.164|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.164|3.452|<0.0001
91785262|NCT01708902|183451026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.574|STANDARD_ERROR_OF_MEAN|0.655||0.0002|TWO_SIDED|95.0|1.563|4.239|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.239|1.563|0.0002
91600420|NCT03505021|183092006|SUPERIORITY||Mean Difference (Final Values)|0.258||||0.8253|TWO_SIDED|95.0|-2.032|2.547|||ANCOVA|||||2.547|-2.032|0.8253
91600421|NCT03505021|183092007|SUPERIORITY||Mean Difference (Final Values)|10.69||||0.4277|TWO_SIDED|95.0|-15.74|37.12|||ANCOVA|||||37.12|-15.74|0.4277
91600422|NCT03505021|183092008|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6733|TWO_SIDED|95.0|0.833|1.327|||Regression, Cox|||||1.327|0.833|0.6733
91600423|NCT03505021|183092009|SUPERIORITY||Mean Difference (Final Values)|3.762||||0.1295|TWO_SIDED|95.0|-1.129|8.654|||ANCOVA|||||8.654|-1.129|0.1295
91600424|NCT03505021|183092010|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.623|TWO_SIDED|95.0|-0.04|0.066|||Mixed Models Analysis|||||0.066|-0.040|0.6230
91600425|NCT03505021|183092011|SUPERIORITY||Mean Difference (Final Values)|-0.272||||0.1752|TWO_SIDED|95.0|-0.666|0.122|||ANCOVA|||||0.122|-0.666|0.1752
91600426|NCT06523491|183092031|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||No sample size calculation was performed. In the survey took part 57 patients from the parent study and OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at the end of 12-month follow-up (EOF) visit was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
91600427|NCT06523491|183092031|SUPERIORITY||LS-means difference|353.18|STANDARD_ERROR_OF_MEAN|72.27||0|TWO_SIDED|95.0|178.91|527.45||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||527.45|178.91|0.00
91600428|NCT06523491|183092031|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
91600429|NCT06523491|183092031|SUPERIORITY||LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
91600430|NCT06523491|183092031|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||The between-group comparison of changes from baseline (study 1 visit 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
91600431|NCT06523491|183092031|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
91600432|NCT06523491|183092031|SUPERIORITY||[LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
91600433|NCT01299766|183092059|SUPERIORITY||Risk Ratio (RR)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.74|||Poisson regression with robust SE (GEE)|||Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.||0.74|0.02|.02
91600434|NCT01299766|183092060|SUPERIORITY||Difference in Slopes|2.47||||0.064|TWO_SIDED|95.0|-0.14|5.07|||Mixed Models Analysis|||Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.||5.07|-.14|.064
91600435|NCT00804687|183092106|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0602||95.0|-0.258|0.006|||Linear mixed model|||||0.006|-0.258|0.0602
91600436|NCT00804687|183092106|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.195|STANDARD_ERROR_OF_MEAN|0.067||0.0043||95.0|-0.328|-0.063|||Linear mixed model|||||-0.063|-0.328|0.0043
91600437|NCT00804687|183092106|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.066|STANDARD_ERROR_OF_MEAN|0.07||0.3513|TWO_SIDED|95.0|-0.206|0.075|||Linear mixed model|||||0.075|-0.206|0.3513
91600438|NCT00804687|183092107|SUPERIORITY_OR_OTHER||Least Squares Mean difference|8.604|STANDARD_ERROR_OF_MEAN|2.267||0.0003||95.0|4.104|13.104|||Linear mixed model|||||13.104|4.104|0.0003
91600439|NCT00804687|183092107|SUPERIORITY_OR_OTHER||Least Squares Mean difference|4.699|STANDARD_ERROR_OF_MEAN|2.289||0.0428||95.0|0.155|9.243|||Linear mixed model|||||9.243|0.155|0.0428
91600440|NCT00804687|183092107|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-3.905|STANDARD_ERROR_OF_MEAN|2.277||0.0895|TWO_SIDED|95.0|-8.424|0.614|||Linear mixed model|||||0.614|-8.424|0.0895
91600441|NCT00805740|183092130|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.8|||||TWO_SIDED|95.0|-12.3|53.3||||||The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||53.3|-12.3|
91600442|NCT00805740|183092131|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.6|||||TWO_SIDED|95.0|-13.6|55.6||||||2-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.6|-13.6|
91600443|NCT00805740|183092131|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1|||||TWO_SIDED|95.0|-23.3|47.3||||||6-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||47.3|-23.3|
91650083|NCT01267266|183192568|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Log Rank|||||||0.20
91785263|NCT01708902|183451026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.682|STANDARD_ERROR_OF_MEAN|1.27|<|0.0001|TWO_SIDED|95.0|2.751|7.968|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.968|2.751|<0.0001
91785264|NCT01708902|183451027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135|STANDARD_ERROR_OF_MEAN|1.31||0.0062|TWO_SIDED|95.0|1.383|7.11|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.110|1.383|0.0062
91785265|NCT01708902|183451028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0109|TWO_SIDED|95.0|-0.53|-0.07|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.07|-0.53|0.0109
91600444|NCT00805740|183092133|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.1|||||TWO_SIDED|95.0|-39.0|27.9||||||The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||27.9|-39.0|
91600445|NCT05227690|183092151|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
91600446|NCT05227690|183092151|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
91600447|NCT05227690|183092152|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
91600448|NCT05227690|183092152|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
91600449|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.1|=|0.3596|TWO_SIDED|95.0|-3.2|1.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||1.2|-3.2|=0.3596
91600450|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.1|=|0.6053|TWO_SIDED|95.0|-2.7|1.6|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||1.6|-2.7|=0.6053
91600451|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.54|=|0.8149|TWO_SIDED|95.0|-3.4|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||2.7|-3.4|=0.8149
91600452|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.55|=|0.9058|TWO_SIDED|95.0|-3.2|2.9|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||2.9|-3.2|=0.9058
91600453|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.71|=|0.5419|TWO_SIDED|95.0|-4.4|2.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||2.3|-4.4|=0.5419
91600454|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.72|=|0.8585|TWO_SIDED|95.0|-3.1|3.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||3.7|-3.1|=0.8585
91650084|NCT01335477|183192575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.73|STANDARD_ERROR_OF_MEAN|24.907||0.0002||95.0|44.78|142.68||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix.~Nintedanib 150 mg bid versus Placebo."|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||142.68|44.78|0.0002
91522624|NCT05805657|182920277|SUPERIORITY||Coefficient of indirect effect|-2.76||||0.001|TWO_SIDED|95.0|-4.44|-1.08|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at post||-1.08|-4.44|0.001
91522625|NCT05805657|182920277|SUPERIORITY||Time by treatment interaction coeff.|0.84||||0.78|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Standard TranS-C versus Adapted TranS-C on change in functional impairment from pre to post.||||0.78
91522626|NCT05805657|182920277|SUPERIORITY||Coefficient|-1.41||||0.49|TWO_SIDED||||||Regression, Linear|||Acceptability of intervention measure (AIM) predicting functional impairment.||||0.49
91522627|NCT05805657|182920277|SUPERIORITY||Coefficient|-1.62||||0.27|TWO_SIDED||||||Regression, Linear|||Appropriateness of intervention measure (IAM) predicting functional impairment.||||0.27
91522628|NCT05805657|182920277|SUPERIORITY||Coefficient|-2.07||||0.09|TWO_SIDED||||||Regression, Linear|||Feasibility of intervention measure (FIM) predicting functional impairment.||||0.09
91650085|NCT01335477|183192576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.151||0.0197||95.0|-4.95|-0.43|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||-0.43|-4.95|0.0197
91785266|NCT01708902|183451028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.27|-0.81|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.81|-1.27|<0.0001
91785267|NCT01708902|183451028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.24|-0.70|<0.0001
91785268|NCT01708902|183451028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.58|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.58|-1.04|<0.0001
91785269|NCT01708902|183451029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.32||0.0001|TWO_SIDED|95.0|-1.87|-0.63|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|"The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.~The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate."||-0.63|-1.87|0.0001
91785270|NCT01708902|183451030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986|STANDARD_ERROR_OF_MEAN|0.387||0.9705|TWO_SIDED|95.0|0.456|2.13|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.130|0.456|0.9705
91785271|NCT01708902|183451030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.093|STANDARD_ERROR_OF_MEAN|1.029||0.0007|TWO_SIDED|95.0|1.612|5.938|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.938|1.612|0.0007
91785272|NCT01708902|183451030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|STANDARD_ERROR_OF_MEAN|1.243||0.0029|TWO_SIDED|95.0|1.486|6.849|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.849|1.486|0.0029
91785273|NCT01708902|183451030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.871|STANDARD_ERROR_OF_MEAN|1.846|<|0.0001|TWO_SIDED|95.0|2.318|10.238|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.238|2.318|<0.0001
91785274|NCT01708902|183451031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.865|STANDARD_ERROR_OF_MEAN|1.015||0.2523|TWO_SIDED|95.0|0.642|5.42|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.420|0.642|0.2523
91785275|NCT01708902|183451032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.37|STANDARD_ERROR_OF_MEAN|3.23||0.0971|TWO_SIDED|95.0|-11.72|0.98|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||0.98|-11.72|0.0971
91785276|NCT01708902|183451032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.42|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-38.67|-26.16|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-26.16|-38.67|<0.0001
91785277|NCT01708902|183451032|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.47|STANDARD_ERROR_OF_MEAN|3.16||0.0028|TWO_SIDED|95.0|-15.66|-3.27|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-3.27|-15.66|0.0028
91785278|NCT01708902|183451032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.31|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-30.54|-18.08|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-18.08|-30.54|<0.0001
91600455|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.99|=|0.5521|TWO_SIDED|95.0|-5.1|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||2.7|-5.1|=0.5521
91600456|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.0|=|0.754|TWO_SIDED|95.0|-4.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||3.3|-4.6|=0.7540
91600457|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.12|=|0.4842|TWO_SIDED|95.0|-5.7|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||2.7|-5.7|=0.4842
91650086|NCT01335477|183192577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.005||95.0|0.19|0.77|||Log Rank||Nintedanib 150 mg bid versus Placebo.|Hazard Ratio is based on a Cox's regression model with terms for treatment, gender, age and height.||0.77|0.19|0.0050
91650087|NCT01335477|183192578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.77|STANDARD_ERROR_OF_MEAN|19.808|<|0.0001||95.0|70.92|148.62|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.62|70.92|<0.0001
91785279|NCT01708902|183451033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.21|STANDARD_ERROR_OF_MEAN|9.23||0.0002|TWO_SIDED|95.0|-53.48|-16.95|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-16.95|-53.48|0.0002
91785280|NCT01708902|183451034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209|STANDARD_ERROR_OF_MEAN|0.148||0.0271|TWO_SIDED|95.0|0.052|0.838|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.838|0.052|0.0271
91785281|NCT01708902|183451034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.965|STANDARD_ERROR_OF_MEAN|0.916||0.9699|TWO_SIDED|95.0|0.15|6.202|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||6.202|0.150|0.9699
91785282|NCT01708902|183451034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.183|STANDARD_ERROR_OF_MEAN|0.147||0.0343|TWO_SIDED|95.0|0.038|0.882|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.882|0.038|0.0343
91785283|NCT01708902|183451035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.114|STANDARD_ERROR_OF_MEAN|0.125||0.0474|TWO_SIDED|95.0|0.013|0.976|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||0.976|0.013|0.0474
91785284|NCT02445794|183451064|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||.008
91785285|NCT01057589|183451073|SUPERIORITY_OR_OTHER|||||||0.697||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.697
91785286|NCT01057589|183451073|SUPERIORITY_OR_OTHER|||||||0.132||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.132
91785287|NCT01057589|183451074|SUPERIORITY_OR_OTHER|||||||0.223||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.223
91785288|NCT01057589|183451074|SUPERIORITY_OR_OTHER|||||||0.788||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.788
91785289|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.90
91785290|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.31||||||P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.31
91785291|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.49||||||P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.49
91785292|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.95||||||P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.95
91785293|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.89||||||P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.89
91785294|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.36||||||P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.36
91785295|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.18
91785296|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.47||||||P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.47
91522629|NCT05805657|182920278|SUPERIORITY||Time by treatment interaction coeff.|-4.25||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.||||0.002
91522630|NCT05805657|182920278|SUPERIORITY||Coefficient of indirect effect|-1.95||||0.02|TWO_SIDED|95.0|-3.54|-0.36|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.36|-3.54|0.02
91522631|NCT05805657|182920278|SUPERIORITY||Coefficient of indirect effect|-1.62||||0.01|TWO_SIDED|95.0|-2.87|-0.38|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.||-0.38|-2.87|0.01
91522632|NCT05805657|182920278|SUPERIORITY||Time by treatment interaction coeff.|1.79||||0.56|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Standard TranS-C versus Adapted TranS-C on change in psychiatric symptoms from pre to post.||||0.56
91522633|NCT05805657|182920278|SUPERIORITY||Coefficient|-3.46||||0.34|TWO_SIDED||||||Regression, Linear|||Acceptability of intervention measure (AIM) predicting psychiatric symptoms.||||0.34
91522634|NCT05805657|182920278|SUPERIORITY||Coefficient|-5.54||||0.01|TWO_SIDED||||||Regression, Linear|||Appropriateness of intervention measure (IAM) predicting psychiatric symptoms.||||0.01
91522635|NCT05805657|182920278|SUPERIORITY||Coefficient|-5.65||||0.01|TWO_SIDED||||||Regression, Linear|||Feasibility of intervention measure (FIM) predicting psychiatric symptoms.||||0.01
91522636|NCT01951638|182920302|OTHER||Log-Scale mean difference|0.137|||=|0.8991|TWO_SIDED|90.0|-0.04|0.31|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups BAY1021189 (2.5mg, 2.5 to 5mg, 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the comparison groups is difference of means on the log scale.||0.31|-0.04|= 0.8991
91600458|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.13|=|0.6999|TWO_SIDED|95.0|-5.0|3.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||3.4|-5.0|=0.6999
91785297|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
91785298|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.45||||||P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.45
91785299|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.29
91785300|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
91785301|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.70
91785302|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.21||||||P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.21
91785303|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.85
91522637|NCT01951638|182920302|OTHER||Log-Scale mean difference|0.076|||=|0.7194|TWO_SIDED|95.0|-0.18|0.33|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.33|-0.18|= 0.7194
91785304|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.13||||||P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.13
91785305|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.03
91785306|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.71||||||P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.71
91785307|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.34
91785308|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.41
91785309|NCT01057589|183451075|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.37
91785310|NCT01497366|183451108|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.|Difference in percentages|0.3|||||TWO_SIDED|95.0|-7.5|8.0|||||The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.|||8.0|-7.5|
91785311|NCT02745080|183451127|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0719|TWO_SIDED|95.0|0.98|1.72|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.72|0.98|0.0719
91785312|NCT02745080|183451128|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.0001|TWO_SIDED|95.0|1.67|3.71|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||3.71|1.67|<0.0001
91785313|NCT02745080|183451129|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2251|TWO_SIDED|95.0|0.9|1.55|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.55|0.90|0.2251
91785314|NCT02745080|183451130|SUPERIORITY||least squares (LS) mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.038||0.5465|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||Mixed model repeated measures (MMRM) with treatment group, analysis visit as factors, weight/baseline score as covariates, treatment by analysis visit, baseline score by analysis visit as interation terms and unstructured covariance structure|||0.05|-0.10|0.5465
91600459|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
91600460|NCT05227690|183092153|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
91600461|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.061|=|0.5822|TWO_SIDED|95.0|-0.15|0.09|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||0.09|-0.15|=0.5822
91600462|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.061|=|0.9244|TWO_SIDED|95.0|-0.11|0.13|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||0.13|-0.11|=0.9244
91600463|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088|=|0.9348|TWO_SIDED|95.0|-0.17|0.18|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||0.18|-0.17|=0.9348
91600464|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.089|=|0.716|TWO_SIDED|95.0|-0.21|0.14|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||0.14|-0.21|=0.7160
91600465|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|=|0.6883|TWO_SIDED|95.0|-0.24|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.16|-0.24|=0.6883
91600466|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.5973|TWO_SIDED|95.0|-0.14|0.25|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.25|-0.14|=0.5973
91600467|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11|=|0.1392|TWO_SIDED|95.0|-0.38|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||0.05|-0.38|=0.1392
91650088|NCT01335477|183192579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001||95.0|2.78|5.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.69|2.78|<0.0001
91650089|NCT01335477|183192580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|0.607|<|0.0001||95.0|1.87|4.25|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.25|1.87|<0.0001
91600468|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.111|=|0.9421|TWO_SIDED|95.0|-0.21|0.23|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||0.23|-0.21|=0.9421
91522638|NCT01951638|182920302|OTHER||Log-Scale mean difference|0.156|||=|0.8653|TWO_SIDED|95.0|-0.12|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.12|= 0.8653
91600469|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.116|=|0.5431|TWO_SIDED|95.0|-0.3|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||0.16|-0.30|=0.5431
91785315|NCT02745080|183451131|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1498|TWO_SIDED|95.0|0.91|1.87|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.87|0.91|0.1498
91600470|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117|=|0.816|TWO_SIDED|95.0|-0.2|0.26|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||0.26|-0.20|=0.8160
91600471|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
91785316|NCT00829504|183451157|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.16||||||90.0|95.5|105.04|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.04|95.5|
91522639|NCT01951638|182920302|OTHER||Log-Scale mean difference|0.171|||=|0.9041|TWO_SIDED|95.0|-0.09|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.09|= 0.9041
91600472|NCT05227690|183092154|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
91650090|NCT01335477|183192581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001||95.0|2.76|5.67|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.67|2.76|<0.0001
91650091|NCT01335477|183192584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.286||||0.1833||95.0|0.89|1.86|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||1.86|0.89|0.1833
91650092|NCT01335477|183192585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.794||||0.0011||95.0|1.26|2.55|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted.||2.55|1.26|0.0011
91650093|NCT01335477|183192586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.664||||0.0218||95.0|1.08|2.57|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||2.57|1.08|0.0218
91600473|NCT05227690|183092155|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.9|||=|0.0904|TWO_SIDED|95.0|0.9|3.99|||Regression, Logistic|||Emraclidine 30 mg versus Placebo||3.99|0.90|=0.0904
91650094|NCT01335477|183192587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.675||0.4019||95.0|-4.69|1.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.88|-4.69|0.4019
91650095|NCT01335477|183192588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.342||0.022||95.0|-5.71|-0.45|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ impact component-by-visit and random effect for patient||-0.45|-5.71|0.0220
91650096|NCT01335477|183192589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|1.36||0.0152||95.0|-5.97|-0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||-0.64|-5.97|0.0152
91650097|NCT01335477|183192590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|1.192||0.0089||95.0|-5.46|-0.79|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||-0.79|-5.46|0.0089
91650098|NCT01335477|183192591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.685||0.1587||95.0|-5.68|0.93|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||0.93|-5.68|0.1587
91650099|NCT01335477|183192592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|1.713||0.2326||95.0|-1.31|5.41|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||5.41|-1.31|0.2326
91650100|NCT01335477|183192593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|1.564||0.2475||95.0|-1.26|4.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.88|-1.26|0.2475
91650101|NCT01335477|183192594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379||||0.069||95.0|0.98|1.95|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with term treatment||1.95|0.98|0.0690
91650102|NCT01335477|183192596|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.007||95.0|0.19|0.77|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150 mg bid versus Placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||0.77|0.19|0.0070
91650103|NCT01335477|183192597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2995||95.0|0.4|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.40|0.2995
91522640|NCT01951638|182920302|OTHER||Log-Scale mean difference|0.052|||=|0.6572|TWO_SIDED|95.0|-0.2|0.3|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.3|-0.2|= 0.6572
91600474|NCT05227690|183092155|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.96|||=|0.0756|TWO_SIDED|95.0|0.93|4.13|||Regression, Logistic|||Emraclidine 10 mg versus Placebo||4.13|0.93|=0.0756
91650104|NCT01335477|183192598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6654||95.0|0.39|1.9|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.90|0.39|0.6654
91650105|NCT01335477|183192599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.2209||95.0|0.34|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.34|0.2209
91785317|NCT00829504|183451158|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.76||||||90.0|95.45|108.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.49|95.45|
91785318|NCT00829504|183451159|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.1||||||90.0|95.64|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|95.64|
91785319|NCT02248675|183451161|SUPERIORITY_OR_OTHER|||||||0.153|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||.153
91600475|NCT05227690|183092162|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.2418|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|0.0|=0.2418
91600476|NCT05227690|183092162|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.572|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.5720
91600477|NCT05227690|183092162|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.7459|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.7459
91600478|NCT05227690|183092162|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.6729|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6729
91600479|NCT05227690|183092163|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.3783|TWO_SIDED|95.0|-0.1|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|-0.1|=0.3783
91600480|NCT05227690|183092163|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.2242|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.0|-0.2|=0.2242
91600481|NCT05227690|183092163|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.8626|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.8626
91600482|NCT05227690|183092163|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.6106|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6106
91650106|NCT01335477|183192600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.1664||95.0|0.37|1.21|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.21|0.37|0.1664
91785320|NCT02248675|183451162|SUPERIORITY_OR_OTHER|||||||0.627|||||||Regression, Linear|||||||.627
91785321|NCT02248675|183451163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
91785322|NCT02248675|183451164|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
91785323|NCT03745820|183451170|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.328|=|0.8472|TWO_SIDED|95.0|-2.88|2.37|||MMRM|||Mixed Model Repeated Measures(MMRM)model was used to analyze change from baseline of outcome measure(OM)using fixed effects of treatment group,region,study visit,study visit-by-treatment interaction,baseline value of OM,baseline-by-visit interaction.||2.37|-2.88|=0.8472
91600483|NCT05227690|183092164|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.4219|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.1|0.0|=0.4219
91600484|NCT05227690|183092164|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.3933|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|0.0|=0.3933
91600485|NCT05227690|183092164|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.7366|TWO_SIDED|95.0|0.0|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.0|0.0|=0.7366
91600486|NCT05227690|183092164|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.4639|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.0|-0.1|=0.4639
91600487|NCT04669678|183092167|OTHER||Odds Ratio (OR)|0.85||||0.306|TWO_SIDED|90.0|0.65|1.11|||Mixed Models Analysis|||Week 2||1.11|0.65|0.306
91600488|NCT04669678|183092167|OTHER||Odds Ratio (OR)|0.81||||0.874|TWO_SIDED|90.0|0.6|1.09|||Mixed Models Analysis|||Week 4||1.09|0.60|0.874
91600489|NCT04669678|183092167|OTHER||Odds Ratio (OR)|1.04||||0.646|TWO_SIDED|90.0|0.91|1.19|||Mixed Models Analysis|||Week 8||1.19|0.91|0.646
91600490|NCT04669678|183092167|OTHER||Odds Ratio (OR)|1.02||||0.869|TWO_SIDED|90.0|0.82|1.28|||Mixed Models Analysis|||Week 12||1.28|0.82|0.869
91600491|NCT04669678|183092167|OTHER||Odds Ratio (OR)|0.51||||0.044|TWO_SIDED|90.0|0.3|0.88|||Mixed Models Analysis|||Week 2||0.88|0.30|0.044
91600492|NCT04669678|183092167|OTHER||Odds Ratio (OR)|0.36|||<|0.001|TWO_SIDED|90.0|0.28|0.46|||Mixed Models Analysis|||Week 4||0.46|0.28|<0.001
91785324|NCT03745820|183451170|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.323|=|0.8053|TWO_SIDED|95.0|-2.94|2.29|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.29|-2.94|=0.8053
91785325|NCT03745820|183451174|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|1.835|=|0.0637|TWO_SIDED|95.0|-0.2|7.06|||ANCOVA|||An analysis of covariance (ANCOVA) model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.20|=0.0637
91600493|NCT04669678|183092167|OTHER||Odds Ratio (OR)|0.37|||<|0.001|TWO_SIDED|90.0|0.27|0.49|||Mixed Models Analysis|||Week 8||0.49|0.27|<0.001
91600494|NCT04669678|183092167|OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|90.0|0.35|0.54|||Mixed Models Analysis|||Week 12||0.54|0.35|<0.001
91600495|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.25||||0.641|TWO_SIDED|90.0|0.57|2.74|||Mixed Models Analysis|||Week 2||2.74|0.57|0.641
91600496|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.57||||0.204|TWO_SIDED|90.0|0.87|2.8|||Mixed Models Analysis|||Week 4||2.80|0.87|0.204
91785326|NCT03745820|183451174|SUPERIORITY||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|1.844|=|0.0659|TWO_SIDED|95.0|-0.23|7.06|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.23|=0.0659
91785327|NCT03745820|183451175|SUPERIORITY||LS Mean Difference|0.208|STANDARD_ERROR_OF_MEAN|0.09|=|0.6653|TWO_SIDED|95.0|-0.32|0.5|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.50|-0.32|=0.6653
91600497|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.29||||0.415|TWO_SIDED|90.0|0.77|2.15|||Mixed Models Analysis|||Week 8||2.15|0.77|0.415
91600498|NCT04669678|183092168|OTHER||Odds Ratio (OR)|2.23||||0.027|TWO_SIDED|90.0|1.23|4.06|||Mixed Models Analysis|||Week 12||4.06|1.23|0.027
91600499|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.86||||0.274|TWO_SIDED|90.0|0.73|4.73|||Mixed Models Analysis|||Week 2||4.73|0.73|0.274
91600500|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.83||||0.065|TWO_SIDED|90.0|1.07|3.13|||Mixed Models Analysis|||Week 4||3.13|1.07|0.065
91600501|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.72||||0.252|TWO_SIDED|90.0|0.79|3.75|||Mixed Models Analysis|||Week 8||3.75|0.79|0.252
91600502|NCT04669678|183092168|OTHER||Odds Ratio (OR)|2.61||||0.002|TWO_SIDED|90.0|1.57|4.33|||Mixed Models Analysis|||Week 12||4.33|1.57|0.002
91600503|NCT04669678|183092168|OTHER||Odds Ratio (OR)|0.78||||0.46|TWO_SIDED|90.0|0.46|1.34|||Mixed Models Analysis|||Week 20||1.34|0.46|0.460
91600504|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.59||||0.019|TWO_SIDED|90.0|1.15|2.2|||Mixed Models Analysis|||Week 24||2.20|1.15|0.019
91600505|NCT04669678|183092168|OTHER||Odds Ratio (OR)|2.16||||0.061|TWO_SIDED|90.0|1.1|4.27|||Mixed Models Analysis|||Week 2||4.27|1.10|0.061
91600506|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.64||||0.106|TWO_SIDED|90.0|0.99|2.71|||Mixed Models Analysis|||Week 4||2.71|0.99|0.106
91600507|NCT04669678|183092168|OTHER||Odds Ratio (OR)|1.77||||0.144|TWO_SIDED|90.0|0.93|3.36|||Mixed Models Analysis|||Week 8||3.36|0.93|0.144
91600508|NCT04669678|183092168|OTHER||Odds Ratio (OR)|2.37||||0.011|TWO_SIDED|90.0|1.36|4.16|||Mixed Models Analysis|||Week 12||4.16|1.36|0.011
91650107|NCT01335477|183192601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2123||95.0|0.55|1.16|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.16|0.55|0.2123
91785328|NCT03745820|183451175|SUPERIORITY||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.1|=|0.614|TWO_SIDED|95.0|-0.3|0.51|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.51|-0.30|=0.6140
91600509|NCT02634580|183092171|SUPERIORITY||LS Mean Treatment Difference|-39.35|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-47.23|-31.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.48|-47.23|<0.0001
91600510|NCT02634580|183092172|SUPERIORITY||LS Mean Treatment Difference|-40.14|STANDARD_ERROR_OF_MEAN|4.26|<|0.0001|TWO_SIDED|95.0|-48.68|-31.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.60|-48.68|< 0.0001
91600511|NCT02634580|183092173|SUPERIORITY||LS Mean Treatment Difference|-77.6|STANDARD_ERROR_OF_MEAN|8.1|<|0.0001|TWO_SIDED|95.0|-93.9|-61.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-61.3|-93.9|<0.0001
91600512|NCT02634580|183092174|SUPERIORITY||LS Mean Treatment Difference|-79.4|STANDARD_ERROR_OF_MEAN|8.7|<|0.0001|TWO_SIDED|95.0|-96.7|-62.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-62.0|-96.7|<0.0001
91600513|NCT02634580|183092175|SUPERIORITY||Treatment Difference|56.41|||<|0.0001|TWO_SIDED|95.0|34.1|70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||70.70|34.10|<0.0001
91600514|NCT02634580|183092176|SUPERIORITY||Treatment Difference|52.63|||<|0.0001|TWO_SIDED|95.0|30.36|67.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||67.52|30.36|< 0.0001
91600515|NCT02634580|183092177|SUPERIORITY||LS Mean Treatment Difference|-25.44|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-30.8|-20.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.08|-30.80|<0.0001
91600516|NCT02634580|183092178|SUPERIORITY||LS Mean Treatment Difference|-25.83|STANDARD_ERROR_OF_MEAN|2.89|<|0.0001|TWO_SIDED|95.0|-31.63|-20.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.04|-31.63|<0.0001
91600517|NCT02634580|183092179|SUPERIORITY||LS Mean Treatment Difference|-33.53|STANDARD_ERROR_OF_MEAN|3.42|<|0.0001|TWO_SIDED|95.0|-40.38|-26.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-26.68|-40.38|< 0.0001
91600518|NCT02634580|183092180|SUPERIORITY||LS Mean Treatment Difference|-33.44|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-40.94|-25.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-25.94|-40.94|<0.0001
91600519|NCT02634580|183092181|SUPERIORITY||LS Mean Treatment Difference|-35.67|STANDARD_ERROR_OF_MEAN|3.31|<|0.0001|TWO_SIDED|95.0|-42.3|-29.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.04|-42.30|< 0.0001
91600520|NCT02634580|183092182|SUPERIORITY||LS Mean Treatment Difference|-36.6|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-43.98|-29.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.22|-43.98|<0.0001
91785329|NCT03745820|183451176|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.033|=|0.2886|TWO_SIDED|95.0|-3.14|0.94|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.94|-3.14|=0.2886
91650108|NCT01335477|183192602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.213||0.2032||95.0|-0.15|0.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.69|-0.15|0.2032
91650109|NCT01335477|183192603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.1005||0.26||95.0|-0.084|0.31|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.310|-0.084|0.2600
91650110|NCT03549130|183192606|SUPERIORITY||Least Square (LS) mean difference|-0.77||||0.2446|TWO_SIDED|95.0|-2.06|0.53||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.53|-2.06|0.2446
91650111|NCT03549130|183192606|SUPERIORITY||LS mean difference|-1.8||||0.0333|TWO_SIDED|95.0|-3.45|-0.14||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||-0.14|-3.45|0.0333
91650112|NCT03549130|183192606|SUPERIORITY||LS mean difference|-1.63||||0.0345|TWO_SIDED|95.0|-3.13|-0.12||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||-0.12|-3.13|0.0345
91650113|NCT03549130|183192606|SUPERIORITY||LS mean difference|-0.71||||0.1711|TWO_SIDED|95.0|-1.72|0.31||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.31|-1.72|0.1711
91785330|NCT03745820|183451176|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.032|=|0.6349|TWO_SIDED|95.0|-1.55|2.53|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.53|-1.55|=0.6349
91650114|NCT03549130|183192607|SUPERIORITY||LS mean difference|-0.47||||0.5063|TWO_SIDED|95.0|-1.85|0.92||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.92|-1.85|0.5063
91785331|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.345|=|0.7372|TWO_SIDED|95.0|-2.21|3.11||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||3.11|-2.21|=0.7372
91785332|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|1.346|=|0.6894|TWO_SIDED|95.0|-3.2|2.12||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||2.12|-3.20|=0.6894
91785333|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|1.162|=|0.0674|TWO_SIDED|95.0|-4.44|0.16||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||0.16|-4.44|=0.0674
91785334|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.161|=|0.7132|TWO_SIDED|95.0|-2.72|1.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||1.87|-2.72|=0.7132
91785335|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|1.203|=|0.9428|TWO_SIDED|95.0|-2.46|2.29||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||2.29|-2.46|=0.9428
91650115|NCT03549130|183192607|SUPERIORITY||LS mean difference|-0.97||||0.2496|TWO_SIDED|95.0|-2.64|0.69||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.69|-2.64|0.2496
91650116|NCT03549130|183192607|SUPERIORITY||LS mean difference|-0.71||||0.3325|TWO_SIDED|95.0|-2.16|0.74||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||0.74|-2.16|0.3325
91650117|NCT03549130|183192607|SUPERIORITY||LS mean difference|-0.81||||0.1088|TWO_SIDED|95.0|-1.81|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.18|-1.81|0.1088
91785336|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|1.202|=|0.4425|TWO_SIDED|95.0|-1.45|3.3||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||3.30|-1.45|=0.4425
91785337|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.597|=|0.3455|TWO_SIDED|95.0|-4.66|1.64||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||1.64|-4.66|=0.3455
91785338|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|1.595|=|0.9686|TWO_SIDED|95.0|-3.09|3.21||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||3.21|-3.09|=0.9686
91785339|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|1.351|=|0.3832|TWO_SIDED|95.0|-1.49|3.85||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.85|-1.49|=0.3832
91785340|NCT03745820|183451177|SUPERIORITY||LS Mean DIfference|1.07|STANDARD_ERROR_OF_MEAN|1.357|=|0.4297|TWO_SIDED|95.0|-1.61|3.75||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.75|-1.61|=0.4297
91600521|NCT02634580|183092183|SUPERIORITY||LS Mean Treatment Difference|-28.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-35.26|-21.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-21.97|-35.26|< 0.0001
91600522|NCT02634580|183092184|SUPERIORITY||LS Mean Treatment Difference|-27.05|STANDARD_ERROR_OF_MEAN|3.47|<|0.0001|TWO_SIDED|95.0|-34.0|-20.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.09|-34.00|< 0.0001
91600523|NCT02634580|183092185|SUPERIORITY||LS Mean Treatment Difference|-37.07|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-43.65|-30.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-30.50|-43.65|<0.0001
91600524|NCT02634580|183092186|SUPERIORITY||LS Mean Treatment Difference|-36.29|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-43.39|-29.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.20|-43.39|<0.0001
91600525|NCT02634580|183092187|SUPERIORITY||LS Mean Treatment Difference|-31.13|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|-41.83|-20.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.43|-41.83|<0.0001
91600526|NCT02634580|183092188|SUPERIORITY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|6.17|<|0.0001|TWO_SIDED|95.0|-43.57|-18.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-18.84|-43.57|<0.0001
91600527|NCT02634580|183092189|SUPERIORITY||LS Mean Treatment Difference|3.49|STANDARD_ERROR_OF_MEAN|7.31||0.63|TWO_SIDED|95.0|-11.15|18.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||18.13|-11.15|0.63
91600528|NCT02634580|183092190|SUPERIORITY||LS Mean Treatment Difference|11.79|STANDARD_ERROR_OF_MEAN|9.52||0.22|TWO_SIDED|95.0|-7.29|30.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||30.87|-7.29|0.22
91600529|NCT02634580|183092191|SUPERIORITY||LS Mean Treatment Difference|7.96|STANDARD_ERROR_OF_MEAN|3.08||0.012|TWO_SIDED|95.0|1.78|14.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||14.14|1.78|0.012
91600530|NCT02634580|183092192|SUPERIORITY||LS Mean Treatment Difference|5.59|STANDARD_ERROR_OF_MEAN|3.2||0.086|TWO_SIDED|95.0|-0.82|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||12.00|-0.82|0.086
91600531|NCT02634580|183092193|SUPERIORITY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|7.26||0.93|TWO_SIDED|95.0|-15.22|13.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||13.87|-15.22|0.93
91785341|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.438|=|0.6245|TWO_SIDED|95.0|-3.55|2.14||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||2.14|-3.55|=0.6245
91785342|NCT03745820|183451177|SUPERIORITY||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|1.436|=|0.2698|TWO_SIDED|95.0|-1.25|4.43||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||4.43|-1.25|=0.2698
91785343|NCT03745820|183451178|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.61|=|0.4654|TWO_SIDED|95.0|-1.65|0.76||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.76|-1.65|=0.4654
91785344|NCT03745820|183451178|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.608|=|0.5886|TWO_SIDED|95.0|-1.53|0.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.87|-1.53|=0.5886
91785345|NCT03745820|183451178|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.655|=|0.9079|TWO_SIDED|95.0|-1.37|1.22||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||1.22|-1.37|=0.9079
91600532|NCT02634580|183092194|SUPERIORITY||LS Mean Treatment Difference|7.64|STANDARD_ERROR_OF_MEAN|9.88||0.44|TWO_SIDED|95.0|-12.15|27.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||27.43|-12.15|0.44
91600533|NCT02653768|183092209|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|95.0|-8.2|-2.0||||||This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||-2.0|-8.2|
91600534|NCT02653768|183092209|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.2|2.3||||||This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||2.3|-5.2|
91600535|NCT02653768|183092209|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0003|TWO_SIDED|95.0|-10.5|-3.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.||-3.2|-10.5|0.0003
91600536|NCT02653768|183092210|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.43|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.||1.3|-0.6|0.43
91600537|NCT02653768|183092211|OTHER||Mean Difference (Final Values)|-2.3||||0.23|TWO_SIDED|95.0|-6.1|1.5|||Mixed Models Analysis|||||1.5|-6.1|0.23
91600538|NCT01970176|183092217|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91600539|NCT01970176|183092218|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91600540|NCT01970176|183092219|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91600541|NCT01562548|183092270|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.21||||0.68|TWO_SIDED|95.0|-1.23|0.8||P-value was associated with t-test for difference of LS means|t-test, 2 sided|The model included factors for treatment (as a fixed effect) and site (as a random effect).|Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||0.80|-1.23|0.68
91600542|NCT01562548|183092270|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.35||||0.52|TWO_SIDED|95.0|-0.72|1.42||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.42|-0.72|0.52
91613669|NCT02078713|183121551|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.71|0.94|0.12
91785346|NCT03745820|183451178|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65|=|0.4441|TWO_SIDED|95.0|-1.78|0.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||0.79|-1.78|=0.4441
91785347|NCT03745820|183451178|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.017|=|0.5537|TWO_SIDED|95.0|-5.18|2.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.79|-5.18|=0.5537
91785348|NCT03745820|183451178|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|2.018|=|0.332|TWO_SIDED|95.0|-5.95|2.02||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.02|-5.95|=0.3320
91600543|NCT01562548|183092270|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.24||||0.58|TWO_SIDED|95.0|-0.64|1.13||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.13|-0.64|0.58
91600544|NCT02161211|183092284|SUPERIORITY|||||||0.673|||||||Chi-squared|df = 2||Null hypothesis = no difference in frequency in relapse between groups||||.673
91600545|NCT02161211|183092285|SUPERIORITY||Wald Chi-squared|-0.278||||0.133|TWO_SIDED|95.0|-0.64|0.084|||Wald Chi-squared|Negative binomial regression with offset of natural log of possible drinking days||||.084|-.64|.133
91600546|NCT02161211|183092285|SUPERIORITY||Wald Chi-squared|0.101||||0.562|TWO_SIDED|95.0|-0.24|0.44|||Wald Chi-squared|||||.44|-.24|.562
91600547|NCT02161211|183092286|SUPERIORITY|||||||0.982|||||||ANOVA|F(2,105) = .019||||||.982
91650118|NCT03549130|183192608|SUPERIORITY||LS mean difference|-0.25||||0.2513|TWO_SIDED|95.0|-0.68|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.68|0.2513
91785349|NCT03745820|183451179|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.128|=|0.8517|TWO_SIDED|95.0|-0.23|0.28|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.28|-0.23|=0.8517
91785350|NCT03745820|183451179|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.128|=|0.9952|TWO_SIDED|95.0|-0.25|0.25|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.25|-0.25|=0.9952
91785351|NCT04250077|183451195|SUPERIORITY||proportion|0.36923076|STANDARD_ERROR_OF_MEAN|0.16518156||0.02578184|TWO_SIDED|95.0|-0.0021812|0.64531855|||Agresti Caffo proportion comparison|||||0.64531855|-0.0021812|0.02578184
91785352|NCT04250077|183451196|SUPERIORITY||Mean Difference (Net)|20.0454545|STANDARD_ERROR_OF_MEAN|7.62386242||0.00787297|TWO_SIDED|95.0|4.18213496|35.9087741|||t-test, 1 sided|||||35.9087741|4.18213496|0.00787297
91785353|NCT04250077|183451197|SUPERIORITY||Mean Difference (Net)|-39.183333|STANDARD_ERROR_OF_MEAN|15.8274398||0.01387108|TWO_SIDED|95.0|-73.356073|-5.0105927|||t-test, 1 sided|||||-5.0105927|-73.356073|0.01387108
91600548|NCT02161211|183092287|SUPERIORITY|||||||0.685|||||||Chi-squared|||Null hypothesis = no difference in proportion between the groups||||.685
91600549|NCT02161211|183092288|SUPERIORITY|||||||0.608|||||||Chi-squared|||Null hypothesis = no significant difference in frequency of hazardous drinking between groups||||.608
91600550|NCT01703858|183092289|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.68|STANDARD_DEVIATION|10.0||0|TWO_SIDED|90.0|92.501|105.272|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.272|92.501|0.0000
91600551|NCT01703858|183092289|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.16|STANDARD_DEVIATION|18.3||0.9644|TWO_SIDED|90.0|62.331|78.962|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||78.962|62.331|0.9644
91600552|NCT01703858|183092289|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.36|STANDARD_DEVIATION|18.8||0.2835|TWO_SIDED|90.0|73.648|94.346|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.346|73.648|0.2835
91600553|NCT01703858|183092289|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.18|STANDARD_DEVIATION|16.7||0.1599|TWO_SIDED|90.0|104.923|130.867|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.867|104.923|0.1599
91600554|NCT01703858|183092289|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.4|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.072|107.719|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.719|88.072|0.0020
91600555|NCT01703858|183092290|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|89.26|STANDARD_DEVIATION|25.3||0.1261|TWO_SIDED|90.0|75.893|104.973|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||104.973|75.893|0.1261
91600556|NCT01703858|183092290|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|54.57|STANDARD_DEVIATION|47.4||0.9808|TWO_SIDED|90.0|40.711|73.157|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||73.157|40.711|0.9808
91600557|NCT01703858|183092290|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|94.88|STANDARD_DEVIATION|43.2||0.1449|TWO_SIDED|90.0|72.175|124.731|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||124.731|72.175|0.1449
91650119|NCT03549130|183192608|SUPERIORITY||LS mean difference|-0.37||||0.0743|TWO_SIDED|95.0|-0.78|0.04||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.04|-0.78|0.0743
91785354|NCT04250077|183451198|SUPERIORITY||Mean Difference (Net)|8.43728901|STANDARD_ERROR_OF_MEAN|3.28323704||0.00908118|TWO_SIDED|95.0|1.59437702|15.280201|||t-test, 1 sided|||||15.2802010|1.59437702|0.00908118
91785355|NCT04250077|183451199|SUPERIORITY||Mean Difference (Net)|1.47698833|STANDARD_ERROR_OF_MEAN|3.68529034||0.34633293|TWO_SIDED|95.0|-6.1910435|9.14502026|||t-test, 1 sided|||||9.14502026|-6.1910435|0.34633293
91785356|NCT04250077|183451200|SUPERIORITY||Mean Difference (Final Values)|-0.4285714|STANDARD_ERROR_OF_MEAN|2.07315199||0.57872623|TWO_SIDED|95.0|-5.4078121|4.55066924|||t-test, 1 sided|||||4.55066924|-5.4078121|0.57872623
91785357|NCT04250077|183451201|SUPERIORITY||Median Difference (Net)|1.29230769|STANDARD_ERROR_OF_MEAN|0.81588207||0.06283641|TWO_SIDED|95.0|-0.3873203|2.97193574|||t-test, 1 sided|||||2.97193574|-0.3873203|0.06283641
91785358|NCT04250077|183451202|SUPERIORITY||proportion|0.11794871|STANDARD_ERROR_OF_MEAN|0.16796576||0.26422281|TWO_SIDED|95.0|-0.2233244|0.43508919|||Agresti Caffo proportion comparison|||||0.43508919|-0.2233244|0.26422281
91785359|NCT02471612|183451203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||Comparing the sensitivity of APACHE-II and P-POSSUM|McNemar|||"Area under the curve (AUC) is used to measure the size of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \< 0.60 is regarded as poor."||||0.665
91785360|NCT00647270|183451222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.074|TWO_SIDED|95.0|-13.3|7.4|||Chi-squared||Treatment difference between adalimumab 80 mg monthly and placebo divided by the difference between adalimumab 40 mg eow and placebo.|Adalimumab 80 mg monthly versus placebo: The null hypothesis associated with this comparison stated that adalimumab 80 mg monthly would be inferior to placebo with respect to ACR20 response percentage; the alternative hypothesis was that adalimumab 80 mg monthly would be superior to placebo with respect to ACR20 response.||7.4|-13.3|0.074
91785361|NCT00647270|183451222|NON_INFERIORITY_OR_EQUIVALENCE|A sensitivity analysis was proposed for the non-inferiority comparison. If the lower confidence limit of θ80 - θ40 was greater than -0.1, then the non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg eow would be claimed||||||0.74||95.0||||Non - inferiority of adalimumab 80 mg monthly compared with 40 mg eow could not be tested because the null hypothesis of the first comparison was not rejected.|Chi-squared|||The non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg every other week (eow) was to be claimed if at least 50% of the treatment effect of adalimumab 40 mg eow over placebo was to be achieved by adalimumab 80 mg monthly over placebo.||||0.74
91600558|NCT01703858|183092290|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|169.46|STANDARD_DEVIATION|49.7||0.9463|TWO_SIDED|90.0|124.093|231.419|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||231.419|124.093|0.9463
91600559|NCT01703858|183092290|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|81.06|STANDARD_DEVIATION|33.3||0.4564|TWO_SIDED|90.0|65.811|99.848|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||99.848|65.811|0.4564
91600560|NCT01703858|183092291|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.66|STANDARD_DEVIATION|9.9||0|TWO_SIDED|90.0|92.5|105.225|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.225|92.500|0.0000
91600561|NCT01703858|183092291|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.24|STANDARD_DEVIATION|18.3||0.9635|TWO_SIDED|90.0|62.43|79.038|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||79.038|62.430|0.9635
91600562|NCT01703858|183092291|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.46|STANDARD_DEVIATION|18.7||0.2771|TWO_SIDED|90.0|73.774|94.412|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.412|73.774|0.2771
91600563|NCT01703858|183092291|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.16|STANDARD_DEVIATION|16.6||0.1584|TWO_SIDED|90.0|104.958|130.787|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.787|104.958|0.1584
91600564|NCT01703858|183092291|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.41|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.066|107.741|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.741|88.066|0.0020
91600565|NCT01834729|183092294|SUPERIORITY|||||||0.78|||||||Least squares means|||||||0.78
91600566|NCT01834729|183092295|SUPERIORITY|||||||0.57|||||||Least squares means|||||||0.57
91600567|NCT04673786|183092306|EQUIVALENCE|Predefined equivalence margin: -10% to 10%|Treatment difference (%) and 90% CI|2.05|||||TWO_SIDED|90.0|-0.23|4.32|||ANCOVA|Multiple imputation (MI) with the Missing at random (MAR) assumption was applied.||||4.32|-0.23|
91600568|NCT04849780|183092323|NON_INFERIORITY|It was calculated that 80 participants randomized in a 1:1 fashion between the two arms would have at least 80% power to detect a 5 points difference in mean change from baseline overall comfort. Sample size was determined using a 2-sided Satterthwaite t-test assuming unequal variances with an alpha level of 5%. A non-inferiority margin of -5 points was used.|Population Mean Difference|29.279|||||TWO_SIDED|95.0|24.602|33.732|||Bootstrapping methods||Population Mean difference was calculated as Arm 1 minus Arm 2|||33.732|24.602|
91600569|NCT04849780|183092324|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of 3 points was used.|LS Mean|-10.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-12.7|-8.6|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 1 minus Arm 2 (subjects' own contact lens)|||-8.6|-12.7|
91785362|NCT00647270|183451223|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
91785363|NCT00647270|183451224|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
91600570|NCT04849780|183092325|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of -5 points was used.|LS Mean|25.9|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|19.0|32.9|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 2 (senofilcon A), minus Arm 2 (subjects' own contact lens)|||32.9|19.0|
91600571|NCT04849780|183092326|NON_INFERIORITY|A non-inferiority margin of 3 points was used.|LS Mean|-8.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-10.1|-7.0|||Heterogeneous mixed model analysis||Mean difference was calculated as Arm 2 (senofilcon A) minus Arm 2 (subjects' own contact lens)|||-7.0|-10.1|
91600572|NCT00725075|183092327|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-2.26||||0.267|TWO_SIDED|95.0|-6.25|1.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||1.74|-6.25|0.267
91600573|NCT00725075|183092327|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-0.08||||0.966|TWO_SIDED|95.0|-3.91|3.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||3.74|-3.91|0.966
91600574|NCT02340663|183092343|OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
91600575|NCT02340663|183092344|OTHER|||||||0.045|||||||ANOVA|||||||0.045
91600576|NCT02340663|183092345|OTHER|||||||0.665|||||||t-test, 2 sided|||||||0.665
91600577|NCT02340663|183092346|OTHER|||||||0.249|||||||Wilcoxon (Mann-Whitney)|||||||0.249
91600578|NCT02340663|183092347|OTHER|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||||||0.626
91600579|NCT02340663|183092348|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
91785364|NCT00647270|183451224|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
91522641|NCT01951638|182920303|OTHER||Mean Difference (Net)|1.629|||=|0.8156|TWO_SIDED|90.0|-1.36|4.62|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means.||4.62|-1.36|= 0.8156
91600580|NCT02340663|183092349|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||0.255
91600581|NCT02340663|183092350|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||.049
91600582|NCT02340663|183092353|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
91600583|NCT02340663|183092354|OTHER||||||<|0.01||||||The P-value given is the computed value|Mixed Models Analysis|||||||<0.01
91600584|NCT02340663|183092355|OTHER|||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
91600585|NCT02340663|183092356|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.220
91600586|NCT02340663|183092357|OTHER|||||||0.081|||||||Wilcoxon (Mann-Whitney)|||||||0.081
91600587|NCT02340663|183092358|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91600588|NCT02340663|183092359|OTHER|||||||0.731|||||||Wilcoxon (Mann-Whitney)|||||||0.731
91600589|NCT02340663|183092360|OTHER|||||||0.238|||||||Wilcoxon (Mann-Whitney)|||||||0.238
91600590|NCT02340663|183092361|OTHER|||||||0.952||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.952
91600591|NCT02340663|183092362|OTHER|||||||0.53||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.53
91600592|NCT02340663|183092363|OTHER|||||||0.292||||||"The P-value refers to the difference in group means, see Group Means row in the table."|Mixed Models Analysis|||||||0.292
91600593|NCT02340663|183092364|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.||||0.289
91600594|NCT02340663|183092365|OTHER|||||||0.287||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.287
91600595|NCT02340663|183092366|OTHER|||||||0.505||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.505
91600596|NCT02340663|183092367|OTHER|||||||0.643||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.643
91600597|NCT02340663|183092368|OTHER|||||||0.923||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.923
91600598|NCT03694925|183092410|OTHER||Specificity|0.871|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
91600599|NCT03694925|183092410|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
91790491|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193||0.866|TWO_SIDED|95.0|-0.413|0.348||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.348|-0.413|0.866
91600600|NCT03694925|183092410|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
91600601|NCT03694925|183092410|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
91600602|NCT03694925|183092410|OTHER||Positive predictive value|0.852|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
91600603|NCT03694925|183092410|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
91600604|NCT03694925|183092410|OTHER||Negative predictive value|0.984|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
91600605|NCT03694925|183092410|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
91600606|NCT03694925|183092411|OTHER||Specificity|0.829|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
91600607|NCT03694925|183092411|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
91600608|NCT03694925|183092411|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
91600609|NCT03694925|183092411|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
91600610|NCT03694925|183092411|OTHER||Positive predictive value|0.813|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
91600611|NCT03694925|183092411|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
91600612|NCT03694925|183092411|OTHER||Negative predictive value|0.983|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
91600613|NCT03694925|183092411|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. NPV=98.5%|||
91600614|NCT01459705|183092418|SUPERIORITY_OR_OTHER||Slope|-22.34|STANDARD_DEVIATION|4.69|||ONE_SIDED|||||||||||||
91600615|NCT01459705|183092418|SUPERIORITY_OR_OTHER||Slope|-13.3|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|||||||||||||
91600616|NCT01459705|183092418|SUPERIORITY_OR_OTHER||Slope|9.04|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|||||||||||||
91600617|NCT01459705|183092419|SUPERIORITY_OR_OTHER||Slope|15.07|STANDARD_DEVIATION|6.03|||TWO_SIDED|||||||||||||
91600618|NCT01459705|183092420|SUPERIORITY_OR_OTHER||Slope|13.91|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|||||||||||||
91600619|NCT01354028|183092562|SUPERIORITY_OR_OTHER|||||||0.1303||95.0|||||Chi-squared|Degrees of freedom =1||"Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot study"||||0.1303
91600620|NCT01354028|183092565|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Pearson's chi square|Chi-squared|Degrees of freedom=1||"Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98"||||0.026
91600621|NCT02109159|183092566|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.4|||Chi-squared||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||1.4|0.8|0.44
91600622|NCT02109159|183092566|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.47|TWO_SIDED|95.0|0.8|1.7|||Chi-squared||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||1.7|0.8|0.47
91600623|NCT02109159|183092567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||0.04|-0.02|0.53
91600624|NCT02109159|183092567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.56|TWO_SIDED|95.0|-0.5|0.8|||t-test, 2 sided||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||0.8|-0.5|0.56
91600625|NCT03968419|183092578|OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-25.56|21.23||||||Difference in MPR rate||21.23|-25.56|
91600626|NCT01641939|183092589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.8589|TWO_SIDED|95.0|0.87|1.6||One sided p-value with correction for interim treatment selection due to adaptive seamless phase design.|Log Rank|Log-Rank test, inverse normal combination test.||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||1.60|0.87|0.8589
91600627|NCT01641939|183092590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.32|2.03||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||2.03|0.32|
91600628|NCT01641939|183092590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01|||||TWO_SIDED|95.0|0.82|4.92||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||4.92|0.82|
91785365|NCT00647270|183451225|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The ANCOVA Model was adjusted for the Baseline Measure.|ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
91785366|NCT00647270|183451226|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The ANCOVA Model was adjusted for Baseline Measure.|ANCOVA|The ANCOVA Model was adjusted for Baseline Measure.||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
91785367|NCT03615040|183451227|SUPERIORITY||Incidence Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.15||0.195|TWO_SIDED|95.0|0.53|1.14|||t-test, 2 sided|||A generalised linear model (assuming neg. binomial distribution) was used. The model includes the number of exacerbations during the 48 week treatment as an outcome with explanatory variables of treatment arm \& number of exacerbations in the 12 months prior to the trial (stratification factor), and log-time on trial (in weeks) as an offset. The offset, allows for different lengths of time in the trial. Only observed exacerbations were used alongside the corresponding time period in the offset.||1.14|0.53|0.195
91600629|NCT01641939|183092590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.96||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Trastuzumab Emtansine 3.6 mg||0.96|0.23|
91600630|NCT01641939|183092592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.308|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy||1.43|0.89|0.308
91600631|NCT05022641|183092617|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||.6
91600632|NCT05022641|183092618|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||.65
91600633|NCT05022641|183092619|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||.02
91600634|NCT05022641|183092620|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
91600635|NCT05022641|183092622|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||.6
91600636|NCT03881007|183092623|SUPERIORITY||Incidence rate ratio|1.17||||0.359|TWO_SIDED|95.0|0.84|1.64|||Mixed Models Analysis|||||1.64|0.84|0.359
91600637|NCT03881007|183092624|SUPERIORITY||Incidence rate ratio|5.78||||0.024|TWO_SIDED|95.0|1.52|136.56|||Mixed Models Analysis|||||136.56|1.52|0.024
91600638|NCT03881007|183092625|SUPERIORITY||Incidence rate ratio|1.09||||0.774|TWO_SIDED|95.0|0.61|1.95|||Mixed Models Analysis|||||1.95|0.61|0.774
91650120|NCT03549130|183192608|SUPERIORITY||LS mean difference|-0.55||||0.0158|TWO_SIDED|95.0|-0.99|-0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||-0.10|-0.99|0.0158
91650121|NCT03549130|183192608|SUPERIORITY||LS mean difference|-0.47||||0.0489|TWO_SIDED|95.0|-0.94|0.0||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.00|-0.94|0.0489
91600639|NCT03881007|183092626|SUPERIORITY||incidence rate ratio|0.59||||0.323|TWO_SIDED|95.0|0.2|1.63|||Mixed Models Analysis|||||1.63|0.2|0.323
91600640|NCT03881007|183092628|SUPERIORITY||Incidence rate ratio|1.21||||0.279|TWO_SIDED|95.0|0.86|1.72|||Mixed Models Analysis|||||1.72|0.86|0.279
91600641|NCT00847587|183092630|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 8 additional hours was chosen to be clinically relevant, as many common medical interventions (such as epidural anesthesia, cesarean delivery, labor induction, and general stress) have been reported to delay time to lactogenesis stage II by up to 12 hours.|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|120.0|<|0.05|TWO_SIDED|95.0|-10.6|7.7|||t-test, 2 sided|||It was assumed that both groups would have a mean of 54 hours to lactogenesis with a common standard deviation of 12 hours based on previous reports of lactogenesis in women with uncomplicated vaginal deliveries. Setting the noninferiority margin at 8 additional hours, using an alpha 0.05 level comparison, to achieve 80% power a sample size of n=34 evaluable subjects was required in each group. The calculation was performed using N Solution 2007 Professional Software.||7.7|-10.6|<0.05
91600642|NCT00847587|183092631|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.61|STANDARD_DEVIATION|1.8|<|0.05|TWO_SIDED|95.0|-1.3|2.5|||t-test, 2 sided|||||2.5|-1.3|<0.05
91600643|NCT04033367|183092635|SUPERIORITY||Least square mean difference|-15.52|||<|0.001|TWO_SIDED|95.0|-24.13|-6.9||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||-6.90|-24.13|<0.001
91600644|NCT04033367|183092636|SUPERIORITY||Least square mean difference|-27.87|||<|0.001|TWO_SIDED|95.0|-37.96|-17.78||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-17.78|-37.96|<0.001
91600645|NCT04033367|183092637|SUPERIORITY||Least square mean difference|-15.06|||<|0.001|TWO_SIDED|95.0|-20.56|-9.56||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-9.56|-20.56|<0.001
91600646|NCT04033367|183092638|SUPERIORITY||Least square mean difference|-2.08|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-1.18|-2.97|<0.001
91600647|NCT04033367|183092639|SUPERIORITY||Least square mean difference|-3.61|||<|0.001|TWO_SIDED|95.0|-5.68|-1.53||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.53|-5.68|<0.001
91600648|NCT04033367|183092640|SUPERIORITY||Least square mean difference|9.97||||0.297|TWO_SIDED|95.0|-8.86|28.79||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||28.79|-8.86|0.297
91600649|NCT02723201|183092650|SUPERIORITY_OR_OTHER||LS Mean Difference|0.402|||<|0.001|TWO_SIDED|90.0|0.32|0.505|||ANOVA|||Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.||0.505|0.320|<0.001
91600650|NCT02723201|183092650|SUPERIORITY_OR_OTHER||LS Mean Difference|1.216||||0.249|TWO_SIDED|90.0|1.016|1.455|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.455|1.016|0.249
91600651|NCT02723201|183092650|SUPERIORITY_OR_OTHER||LS Mean Difference|0.055|||<|0.001|TWO_SIDED|90.0|0.041|0.074|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.074|0.041|<0.001
91600652|NCT02723201|183092650|SUPERIORITY_OR_OTHER||LS Mean Difference|0.685||||0.054|TWO_SIDED|90.0|0.499|0.939|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.939|0.499|0.054
91600653|NCT02723201|183092652|SUPERIORITY_OR_OTHER||LS Mean Difference|0.648||||0.007|TWO_SIDED|90.0|0.497|0.844|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.844|0.497|0.007
91600654|NCT02723201|183092652|SUPERIORITY_OR_OTHER||LS Mean Difference|1.18||||0.423|TWO_SIDED|90.0|1.088|1.279|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.279|1.088|0.423
91600655|NCT02723201|183092652|SUPERIORITY_OR_OTHER||LS Mean Difference|0.116|||<|0.001|TWO_SIDED|90.0|0.077|0.176|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.176|0.077|<0.001
91600656|NCT02723201|183092652|SUPERIORITY_OR_OTHER||LS Mean Difference|0.836||||0.037|TWO_SIDED|90.0|0.731|0.957|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.957|0.731|0.037
91600657|NCT03193398|183092679|OTHER||Mean Difference (Net)|-1.3||||0.5939|TWO_SIDED|95.0|-6.3|3.6|||MMRM|MMRM: mixed model for repeated measures||Difference in LS Means (BTRX-246040 - Placebo)||3.6|-6.3|0.5939
91600658|NCT03193398|183092680|OTHER||Mean Difference (Net)|-1.0||||0.5503|TWO_SIDED|95.0|-4.4|2.3|||MMRM|MMRM: mixed model for repeated measures||Analysis of Change from Baseline in Investigator-administered MADRS-6 Total Score at week 8||2.3|-4.4|0.5503
91600659|NCT03193398|183092681|OTHER||Mean Difference (Net)|0.8||||0.3906|TWO_SIDED|95.0|-1.1|2.8|||MMRM|MMRM: mixed model for repeated measures||||2.8|-1.1|0.3906
91600660|NCT03193398|183092682|OTHER||Mean Difference (Net)|0.9||||0.4187|TWO_SIDED|95.0|-1.3|3.1||+/-|MMRM|MMRM: mixed model for repeated measures||||3.1|-1.3|0.4187
91600661|NCT03193398|183092683|OTHER||Mean Difference (Net)|-3.0||||0.4869|TWO_SIDED|95.0|-11.5|5.5|||MMRM|MMRM: mixed model for repeated measures||||5.5|-11.5|0.4869
91600662|NCT03193398|183092684|OTHER||Mean Difference (Net)|1.2||||0.5178|TWO_SIDED|95.0|-2.4|4.7|||MMRM|MMRM: mixed model for repeated measures||||4.7|-2.4|0.5178
91600663|NCT05425563|183092690|OTHER||Slope|8.3269|STANDARD_ERROR_OF_MEAN|0.8792|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
91600664|NCT05425563|183092691|OTHER||Slope|8.0809|STANDARD_ERROR_OF_MEAN|0.5414|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
91600665|NCT05425563|183092692|OTHER||Slope|8.121|STANDARD_ERROR_OF_MEAN|0.481|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
91600666|NCT05425563|183092699|OTHER||Slope|34.613|STANDARD_ERROR_OF_MEAN|0.602|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
91600667|NCT05425563|183092700|OTHER||Slope|33.9754|STANDARD_ERROR_OF_MEAN|0.426||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
91600668|NCT05425563|183092701|OTHER||Slope|31.63|STANDARD_ERROR_OF_MEAN|0.422|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
91600669|NCT00997516|183092720|SUPERIORITY_OR_OTHER|||||||0.01||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.01
91600670|NCT00997516|183092721|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||||||<0.01
91600671|NCT00997516|183092730|SUPERIORITY_OR_OTHER|||||||0.86||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Overall body satisfaction||||0.86
91600672|NCT00997516|183092730|SUPERIORITY_OR_OTHER|||||||0.18||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Damage to body||||0.18
91600673|NCT00997516|183092730|SUPERIORITY_OR_OTHER|||||||0.04||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Physical attractiveness||||0.04
91600674|NCT00997516|183092730|SUPERIORITY_OR_OTHER|||||||0.34||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Masculinity/femininity||||0.34
91600675|NCT00997516|183092730|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Looking at oneself naked||||0.63
91600676|NCT00997516|183092731|SUPERIORITY_OR_OTHER|||||||0.48||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of abdomen||||0.48
91600677|NCT00997516|183092731|SUPERIORITY_OR_OTHER|||||||0.09||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of scars||||0.09
91600678|NCT00997516|183092731|SUPERIORITY_OR_OTHER|||||||0.25||||||Significant at p\<0.05|t-test, 2 sided|||Satisfaction with scars||||0.25
91600679|NCT00997516|183092731|SUPERIORITY_OR_OTHER|||||||0.81||||||Significant at p\<0.05|t-test, 2 sided|||Discomfort of scars||||0.81
91600680|NCT00997516|183092731|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||Overall impression of scars||||<0.01
91600681|NCT00584233|183092732|NON_INFERIORITY|The statistical test will be to assess non-inferiority. The non-inferiority margin is -0.04 in AUC. Key parameters are the number of participating patients, the number of radiologists reading the images in the study. Power analysis was conducted using the standard simulation from the ROC literature (Roe and Metz, Academic Radiology 1997). With a total of 100 participating patients and 4 participating readers, we achieve a power \>80% with a non-inferiority margin of -0.04.|Obuchowski Rockette methodology|0.05||||0.05|TWO_SIDED|95.0|0.025|0.975|||Obuchowski Rockette|||The analysis is intended to evaluate non-inferiority in observer performance between CE-bCT and CE-bMRI as assessed by the area under the ROC curve (AUC). The null hypothesis is that the observed difference in average AUC for CE-bCT and CE-bMRI will be outside of a non-inferiority margin of -0.04. See below for details of the power analyses.||.975|.025|0.05
91785368|NCT03615040|183451230|SUPERIORITY||Mean Difference (Net)|-3.3||||0.039|TWO_SIDED|95.0|-6.4|-0.2|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||-0.2|-6.4|0.039
91785369|NCT03615040|183451231|SUPERIORITY||Mean Difference (Net)|0.53||||0.469|TWO_SIDED|95.0|-0.91|2.0|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||2.00|-0.91|0.469
91785370|NCT03615040|183451232|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 4||||0.90
91600682|NCT03178487|183092797|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Response Rate Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for stratification factor of Screening hsCRP level.|Response Rate Difference = Upadacitinib - Placebo|||39.5|12.6|<0.001
91613670|NCT02078713|183121552|SUPERIORITY||Odds Ratio (OR)|1.18||||0.41|TWO_SIDED|95.0|0.8|1.74||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of overall score||1.74|0.80|0.41
91613671|NCT02078713|183121552|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0496|TWO_SIDED|95.0|1.0|1.8|||Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of informed decision subscale||1.80|1.00|0.0496
91785371|NCT03615040|183451232|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 12||||0.95
91785372|NCT03615040|183451232|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 24||||0.78
91785373|NCT03615040|183451232|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 36||||0.88
91785374|NCT03615040|183451232|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 48||||0.78
91785375|NCT03615040|183451233|SUPERIORITY||Mean Difference (Net)|-9.4||||0.236|TWO_SIDED|95.0|-24.9|6.2||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS total||6.2|-24.9|0.236
91785376|NCT03615040|183451233|SUPERIORITY||Mean Difference (Net)|-4.9||||0.083|TWO_SIDED|95.0|-10.6|0.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Dyspnoea||0.7|-10.6|0.083
91785377|NCT03615040|183451233|SUPERIORITY||Mean Difference (Net)|-2.1||||0.546|TWO_SIDED|95.0|-8.9|4.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Cough||4.7|-8.9|0.546
91785378|NCT03615040|183451233|SUPERIORITY||Mean Difference (Net)|-1.9||||0.527|TWO_SIDED|95.0|-7.8|4.0||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Sputum production||4.0|-7.8|0.527
91785379|NCT03615040|183451234|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 12||||0.84
91785380|NCT03615040|183451234|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 24||||0.52
91600683|NCT03178487|183092798|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Least Squares (LS) Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.14|-0.68|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.14|<0.001
91600684|NCT03178487|183092799|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|LS Mean Difference|-6.71|||<|0.001|TWO_SIDED|95.0|-9.01|-4.41|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.41|-9.01|<0.001
91600685|NCT03178487|183092800|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASDAI 50; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|21.8||||0.002|TWO_SIDED|95.0|8.5|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||35.0|8.5|0.002
91600686|NCT03178487|183092801|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASQoL; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.54||||0.016|TWO_SIDED|95.0|-2.78|-0.3|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.30|-2.78|0.016
91600687|NCT03178487|183092802|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASAS PR; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|18.3|||<|0.001|TWO_SIDED|95.0|10.0|26.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||26.6|10.0|<0.001
91600688|NCT03178487|183092803|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASFI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.0||||0.001|TWO_SIDED|95.0|-1.6|-0.39|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.39|-1.60|0.001
91600689|NCT03178487|183092804|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASMI(lin); within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.22||||0.03|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.02|-0.43|0.030
91600690|NCT03178487|183092805|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including MASES; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.84||||0.049|TWO_SIDED|95.0|-1.68|0.0|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.00|-1.68|0.049
91600691|NCT03178487|183092806|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including WPAI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-5.52||||0.19|TWO_SIDED|95.0|-13.82|2.78|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||2.78|-13.82|0.190
91600692|NCT03178487|183092807|OTHER|"To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.~ASAS HI was to be evaluated only if the group of endpoints tested by Hochberg procedure were all significant."|LS Mean Difference|-1.37||||0.007|TWO_SIDED|95.0|-2.37|-0.37||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped during the Hochberg procedure.|Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.37|-2.37|0.007
91785381|NCT03615040|183451234|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 36||||0.82
91785382|NCT03615040|183451234|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 48||||0.95
91785383|NCT03615040|183451235|SUPERIORITY||Mean Difference (Final Values)|9.06||||0.069|TWO_SIDED|95.0|-0.83|18.97|||ANCOVA|||Pre BD FEV1/FVC ratio: Analysis of covariance (ANCOVA) adjusting for the baseline value||18.97|-0.83|0.069
91785384|NCT03615040|183451236|SUPERIORITY||Mean Difference (Net)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.09|||Mixed Models Analysis|||mixed effect linear model with explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score and patient identification as a random effect to account for repeated measures over time was fitted for each outcome. Adjusted mean difference between treatment arms with 95% confidence interval and p-value were reported. In the modified ITT population.||0.09|-0.01|0.094
91785385|NCT03615040|183451237|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.905|TWO_SIDED|95.0|-0.46|0.52||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Total Lung Capacity||0.52|-0.46|0.905
91600693|NCT03178487|183092808|OTHER||Response Rate Difference|24.1||||0.001|TWO_SIDED|95.0|10.2|38.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|||Response Rate Difference = Upadacitinib - Placebo|38.0|10.2|0.001
91600694|NCT03178487|183092809|OTHER||LS Mean Difference|-3.69|||<|0.001|TWO_SIDED|95.0|-5.31|-2.08||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.08|-5.31|<0.001
91785386|NCT03615040|183451237|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.775|TWO_SIDED|95.0|-0.62|0.47||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume||0.47|-0.62|0.775
91600695|NCT03178487|183092810|OTHER||LS Mean Difference|-6.21|||<|0.001|TWO_SIDED|95.0|-8.27|-4.14|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.14|-8.27|<0.001
91600696|NCT03178487|183092811|OTHER||LS Mean Difference|-2.55|||<|0.001|TWO_SIDED|95.0|-4.01|-1.08|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.08|-4.01|<0.001
91600697|NCT03021642|183092936|SUPERIORITY_OR_OTHER_LEGACY||Geometric Least square (LS) mean ratio|98.68|||||TWO_SIDED|90.0|93.67|103.96||||||||103.96|93.67|
91600698|NCT03021642|183092937|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|95.71|||||TWO_SIDED|90.0|88.43|103.59||||||||103.59|88.43|
91600699|NCT03021642|183092938|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|96.88|||||TWO_SIDED|90.0|90.8|103.36||||||||103.36|90.8|
91600700|NCT03021642|183092939|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.8981|TWO_SIDED|90.0|-1.0|1.025|||Wilcoxon signed-rank test|||||1.025|-1.000|0.8981
91600701|NCT02474082|183092978|SUPERIORITY||Odds Ratio (OR)|16.61|||<|0.0001|TWO_SIDED|95.0|7.79|35.4|||Regression, Logistic|||||35.40|7.79|<.0001
91600702|NCT04317274|183092999|OTHER||Slope|-0.19||||0.21|TWO_SIDED||||||Mixed Models Analysis|Note: original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the high cholesterol group.||||0.21
91600703|NCT04317274|183092999|OTHER||Slope|-1.23|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the colorectal cancer group.||||<0.001
91785387|NCT03615040|183451238|SUPERIORITY||Geometric mean ratio|1.01||||0.736|TWO_SIDED|95.0|0.95|1.07||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||White blood cell count||1.07|0.95|0.736
91785388|NCT03615040|183451238|SUPERIORITY||Geometric mean ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.51|0.69||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Eosinophil Count||0.69|0.51|<0.001
91785389|NCT03615040|183451238|SUPERIORITY||Geometric mean ratio|1.02||||0.678|TWO_SIDED|95.0|0.93|1.13||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Neutrophil Count||1.13|0.93|0.678
91600704|NCT04317274|183093000|OTHER||Slope|0.58|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient|||We examined the correlation between SDM Process and SDM-Q9 scores in the high cholesterol group.||||<.001
91600705|NCT04317274|183093000|OTHER||Slope|0.71|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient]|||We examined the correlation between SDM Process and SDM-Q9 scores in the colorectal cancer group.||||<.001
91600706|NCT00430508|183093004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.3|||<|0.0001||95.0|-6.97|-3.6|||ANCOVA|||||-3.6|-6.97|<0.0001
91600707|NCT00430508|183093004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.0001||95.0|-4.79|-2.03|||ANCOVA|||||-2.03|-4.79|<0.0001
91600708|NCT00430508|183093004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1788||95.0|-2.32|0.43|||ANCOVA|||||0.43|-2.32|0.1788
91600709|NCT00430508|183093005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001||95.0|-5.54|-2.6|||ANCOVA|||||-2.6|-5.54|<0.0001
91600710|NCT00430508|183093005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.39|-1.98|||ANCOVA|||||-1.98|-4.39|<0.0001
91600711|NCT00430508|183093005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1081||95.0|-2.19|0.22|||ANCOVA|||||0.22|-2.19|0.1081
91600712|NCT00430508|183093006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|||<|0.0001||95.0|-10.13|-4.66|||ANCOVA|||||-4.66|-10.13|<0.0001
91522642|NCT01951638|182920303|OTHER||Mean Difference (Net)|1.707|||=|0.7945|TWO_SIDED|95.0|-2.39|5.8|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.8|-2.39|= 0.7945
91600713|NCT00430508|183093006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|||<|0.0001||95.0|-7.4|-2.91|||ANCOVA|||||-2.91|-7.4|<0.0001
91600714|NCT00430508|183093006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0255||95.0|-4.79|-0.31|||ANCOVA|||||-0.31|-4.79|0.0255
91600715|NCT00430508|183093007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.6|||<|0.0001||95.0|-9.0|-4.26|||ANCOVA|||||-4.26|-9.00|<0.0001
91600716|NCT00430508|183093007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||<|0.0001||95.0|-6.7|-2.81|||ANCOVA|||||-2.81|-6.70|<0.0001
91600717|NCT00430508|183093007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0812||95.0|-3.66|0.21|||ANCOVA|||||0.21|-3.66|0.0812
91600718|NCT00430508|183093008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||||95.0|1.69|4.21|||Regression, Logistic|||||4.21|1.69|
91600719|NCT00430508|183093008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||||95.0|1.5|3.24|||Regression, Logistic|||||3.24|1.50|
91600720|NCT00430508|183093008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||||95.0|1.07|2.25|||Regression, Logistic|||||2.25|1.07|
91600721|NCT00430508|183093009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|||<|0.0001||95.0|-6.78|-3.36|||ANCOVA|||||-3.36|-6.78|<0.0001
91600722|NCT00430508|183093009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.54|-1.78|||ANCOVA|||||-1.78|-4.54|<0.0001
91600723|NCT00430508|183093009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1452||95.0|-2.43|0.36|||ANCOVA|||||0.36|-2.43|0.1452
91600724|NCT00430508|183093010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.0001||95.0|-6.79|-3.17|||ANCOVA|||||-3.17|-6.79|<0.0001
91600725|NCT00430508|183093010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|||<|0.0001||95.0|-4.79|-1.87|||ANCOVA|||||-1.87|-4.79|<0.0001
91600726|NCT00430508|183093010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1629||95.0|-2.52|0.42|||ANCOVA|||||0.42|-2.52|0.1629
91600727|NCT00430508|183093011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|||<|0.0001||95.0|-7.4|-3.62|||ANCOVA|||||-3.62|-7.40|<0.0001
91600728|NCT00430508|183093011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.0009||95.0|-4.12|-1.07|||ANCOVA|||||-1.07|-4.12|<0.0009
91600729|NCT00430508|183093011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1985||95.0|-2.55|0.53|||ANCOVA|||||0.53|-2.55|0.1985
91785390|NCT03615040|183451239|SUPERIORITY||Geometric mean ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.19|0.33||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Eosinophil count||0.33|0.19|<0.001
91785391|NCT03615040|183451255|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.362|TWO_SIDED|95.0|-0.14|0.35|||ANCOVA|||Pre BD FVC (litres): Analysis of covariance (ANCOVA) adjusting for the baseline value||0.35|-0.14|0.362
91785392|NCT03615040|183451255|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.713|TWO_SIDED|95.0|-0.61|0.44|||ANCOVA|||Pre BD FVC (litre):Analysis of covariance (ANCOVA) adjusting for the baseline value||0.44|-0.61|0.713
91600730|NCT00288080|183093023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398|||||||Log Rank|||The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.||||0.0398
91600731|NCT00288080|183093024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||Log Rank|||Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.||||0.22
91600732|NCT00288080|183093026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Log Rank|||Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.||||0.21
91600733|NCT00288080|183093027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0484|||||||Log Rank|||Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.||||0.0484
91600734|NCT00087646|183093036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.006|TWO_SIDED|95.0|1.21|3.31|||Cochran-Mantel-Haenszel|||Group A Vs Group D||3.31|1.21|0.0060
91600735|NCT00087646|183093037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9228|TWO_SIDED|95.0|0.63|1.51|||Cochran-Mantel-Haenszel|||||1.51|0.63|0.9228
91600736|NCT00087646|183093038|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0006|TWO_SIDED|95.0|1.4|3.52|||Cochran-Mantel-Haenszel|||||3.52|1.40|0.0006
91600737|NCT00087646|183093039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.66|4.18|||Cochran-Mantel-Haenszel|||At Week 12||4.18|1.66|<.0001
91600738|NCT00087646|183093039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1955|TWO_SIDED|95.0|0.89|1.79|||Cochran-Mantel-Haenszel|||At Week 24||1.79|0.89|0.1955
91600739|NCT00087646|183093039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0883|TWO_SIDED|95.0|0.95|1.93|||Cochran-Mantel-Haenszel|||At Week 48||1.93|0.95|0.0883
91600740|NCT00087646|183093040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.67|3.19|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 12)||3.19|1.67|<.0001
91600741|NCT00087646|183093040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3389|TWO_SIDED|95.0|0.85|1.6|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 24)||1.60|0.85|0.3389
91600742|NCT01331304|183093044|SUPERIORITY_OR_OTHER|||||||0.59||||||Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.|Mixed Models Analysis|||For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.||||0.59
91600743|NCT01331304|183093045|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up - to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.||||0.118
91600744|NCT01331304|183093046|SUPERIORITY|||||||0.11||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months||||0.11
91600745|NCT01331304|183093047|SUPERIORITY|||||||0.7||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months||||0.70
91600746|NCT01687712|183093058|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-1.3|8.7|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.7|-1.3|
91600747|NCT01687712|183093059|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.5|8.1|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.1|-2.5|
91600748|NCT01687712|183093063|SUPERIORITY|Comparisons were tested against a null of zero at the two-side 5% significance level.||||||0.612||||||P-values are based upon Type III sums of squares.|ANCOVA|Treatment group and Site are included as factors.||"The null and alternative hypotheses are as follows:~H0: p2- p1 = 0 and H1: p2- p1 ≠0,~where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group."||||0.612
91600749|NCT03551743|183093078|SUPERIORITY||Least Squares Means (Difference)|-65.02||||0.0344|TWO_SIDED||||||ANCOVA|||||||0.0344
91600750|NCT03551743|183093078|SUPERIORITY||Least Squares Means (Difference)|-92.38||||0.0014|TWO_SIDED||||||ANCOVA|||||||0.0014
91600751|NCT03551743|183093078|SUPERIORITY||Least Squares Means (Difference)|-46.26||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
91600752|NCT03551743|183093079|SUPERIORITY||Least Squares Means (Difference)|88722.37||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
91600753|NCT03551743|183093079|SUPERIORITY||Least Squares Means (Difference)|151500.3||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
91600754|NCT03551743|183093079|SUPERIORITY||Least Squares Means (Difference)|198560.4||||0.0004|TWO_SIDED||||||ANCOVA|||||||0.0004
91600755|NCT03551743|183093080|SUPERIORITY||Least Squares Means (Difference)|-76.05||||0.1874|TWO_SIDED||||||ANCOVA|||||||0.1874
91600756|NCT03551743|183093080|SUPERIORITY||Least Squares Means (Difference)|-27.98||||0.386|TWO_SIDED||||||ANCOVA|||||||0.386
91600757|NCT03551743|183093080|SUPERIORITY||Least Squares Means (Difference)|-49.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91600758|NCT03434977|183093089|OTHER||Ratio|0.937|||||TWO_SIDED|90.0|0.89|0.986||||||The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.||0.986|0.890|
91600759|NCT03434977|183093090|OTHER||LS-Means Difference|0.9083|||||TWO_SIDED|90.0|0.1821|1.6345||||||The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.||1.6345|0.1821|
91600760|NCT03434977|183093091|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.943|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.943|
91600761|NCT03434977|183093092|OTHER||Ratio|0.997|||||TWO_SIDED|90.0|0.942|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.942|
91600762|NCT03434977|183093093|OTHER||Ratio|0.985|||||TWO_SIDED|90.0|0.932|1.041||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.||1.041|0.932|
91600763|NCT03434977|183093094|OTHER||Ratio|1.047|||||TWO_SIDED|90.0|1.006|1.091||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.091|1.006|
91600764|NCT03434977|183093095|OTHER||Ratio|1.037|||||TWO_SIDED|90.0|0.996|1.081||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.081|0.996|
91600765|NCT03434977|183093096|OTHER||Ratio|1.014|||||TWO_SIDED|90.0|0.959|1.071||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.||1.071|0.959|
91600766|NCT03434977|183093097|OTHER||Ratio|1.003|||||TWO_SIDED|90.0|0.947|1.062||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.||1.062|0.947|
91600767|NCT03434977|183093098|OTHER||Ratio|0.989|||||TWO_SIDED|90.0|0.916|1.068||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.||1.068|0.916|
91600768|NCT01250379|183093134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0204|TWO_SIDED|95.0|0.65|0.97|||Log Rank||The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.|||0.97|0.65|0.0204
91600769|NCT01250379|183093134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0245|TWO_SIDED|95.0|0.67|0.97|||Log Rank||Unstratified analysis.|||0.97|0.67|0.0245
91785393|NCT03615040|183451256|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.711|TWO_SIDED|95.0|-8.63|12.2|||ANCOVA|||Pre FEV1 predicted: Analysis of covariance (ANCOVA) adjusting for the baseline value||12.20|-8.63|0.711
91785394|NCT03615040|183451256|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.214|TWO_SIDED|95.0|-27.9|7.1|||ANCOVA|||Pre BD FVC predicted (%): Analysis of covariance (ANCOVA) adjusting for the baseline value||7.1|-27.9|0.214
91785395|NCT03615040|183451257|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.201|TWO_SIDED|95.0|-7.53|1.65||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume/Total Lung Capacity ratio.||1.65|-7.53|0.201
91785396|NCT03615040|183451258|SUPERIORITY||Geometric mean ratio|0.75||||0.114|TWO_SIDED|95.0|0.52|1.07||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects|Mixed Models Analysis|||Macrophage count||1.07|0.52|0.114
91709435|NCT04633291|183311480|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.11||||0.63|TWO_SIDED|95.0|-0.36|0.57||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.57|-0.36|0.63
91709436|NCT04633291|183311481|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.15||||0.19|TWO_SIDED|95.0|-0.38|0.08||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.08|-0.38|0.19
91600770|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0088|TWO_SIDED|95.0|0.4|0.88|||Log Rank|||Subgroup analysis: HR-neg||0.88|0.40|0.0088
91600771|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1196|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||Subgroup analysis: HR-pos/HER-neg||1.05|0.67|0.1196
91600772|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.011|TWO_SIDED|95.0|0.43|0.9|||Log Rank|||Subgroup analysis: PFS \<6 months||0.90|0.43|0.0110
91600773|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0816|TWO_SIDED|95.0|0.65|1.03|||Log Rank|||Subgroup analysis: PFS ≥6 months||1.03|0.65|0.0816
91600774|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.0395|TWO_SIDED|95.0|0.31|0.98|||Log Rank|||Subgroup analysis: taxane chemo||0.98|0.31|0.0395
91600775|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1385|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||Subgroup analysis: non-taxane chemo||1.06|0.68|0.1385
91600776|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.0029|TWO_SIDED|95.0|0.22|0.75|||Log Rank|||Subgroup analysis: vinorelbine chemo||0.75|0.22|0.0029
91600777|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0171|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||Subgroup analysis: LDH ≤ 1.5 ULN||0.96|0.62|0.0171
91600778|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1797|TWO_SIDED|95.0|0.46|1.16|||Log Rank|||Subgroup analysis: LDH \> 1.5 ULN||1.16|0.46|0.1797
91600779|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0229|TWO_SIDED|95.0|0.62|0.97|||Log Rank|||Subgroup analysis: \< 65 years of age||0.97|0.62|0.0229
91600780|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.2139|TWO_SIDED|95.0|0.51|1.16|||Log Rank|||Subgroup analysis: ≥ 65 years of age||1.16|0.51|0.2139
91600781|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0021|TWO_SIDED|95.0|0.59|0.89|||Log Rank|||Subgroup analysis: \< 70 years of age||0.89|0.59|0.0021
91600782|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.5216|TWO_SIDED|95.0|0.64|2.39|||Log Rank|||Subgroup analysis: ≥ 70 years of age||2.39|0.64|0.5216
91600783|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0148|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||Subgroup analysis: \< 3 metastatic organ sites||0.94|0.58|0.0148
91600784|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3102|TWO_SIDED|95.0|0.61|1.17|||Log Rank|||Subgroup analysis: ≥ 3 metastatic organ sites||1.17|0.61|0.3102
91600785|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0967|TWO_SIDED|95.0|0.64|1.04|||Log Rank|||Subgroup analysis: B-free ≤ 6 weeks||1.04|0.64|0.0967
91600786|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0489|TWO_SIDED|95.0|0.51|1.0|||Log Rank|||Subgroup analysis: B-free \> 6 weeks||1.00|0.51|0.0489
91600787|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0176|TWO_SIDED|95.0|0.41|0.92|||Log Rank|||Subgroup analysis: D-free ≤ 24 months||0.92|0.41|0.0176
91600788|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2318|TWO_SIDED|95.0|0.66|1.11|||Log Rank|||Subgroup analysis: D-free \> 24 months||1.11|0.66|0.2318
91600789|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0568|TWO_SIDED|95.0|0.26|1.03|||Log Rank|||Subgroup analysis: D-free ≤ 12 months||1.03|0.26|0.0568
91600790|NCT01250379|183093135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1143|TWO_SIDED|95.0|0.66|1.05|||Log Rank|||Subgroup analysis: D-free \> 12 months||1.05|0.66|0.1143
91600791|NCT01250379|183093136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.3457|TWO_SIDED|95.0|-4.2|12.4|||Chi-squared||The 95% CI was estimated using Hauck-Anderson methodology.|||12.4|-4.2|0.3457
91600792|NCT01250379|183093138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9825|TWO_SIDED|95.0|0.51|1.99|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.99|0.51|0.9825
91650122|NCT03549130|183192609|SUPERIORITY||LS mean difference|-0.19||||0.3034|TWO_SIDED|95.0|-0.57|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.57|0.3034
91522643|NCT01951638|182920303|OTHER||Mean Difference (Net)|2.109|||=|0.7917|TWO_SIDED|95.0|-3.01|7.23|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||7.23|-3.01|= 0.7917
91600793|NCT01250379|183093138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.3601|TWO_SIDED|95.0|0.73|2.34|||Log Rank||Unstratified analysis.|||2.34|0.73|0.3601
91600794|NCT01250379|183093141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.108|TWO_SIDED|95.0|0.59|1.06|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.06|0.59|0.1080
91600795|NCT01250379|183093141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0625|TWO_SIDED|95.0|0.59|1.02|||Log Rank||Unstratified analysis.|||1.02|0.59|0.0625
91785397|NCT03615040|183451259|SUPERIORITY||Geometric mean ratio|0.79||||0.215|TWO_SIDED|95.0|0.54|1.15||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Epithelium count||1.15|0.54|0.215
91600796|NCT01250379|183093143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1349|TWO_SIDED|95.0|0.68|1.05|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.05|0.68|0.1349
91600797|NCT01250379|183093143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0863|TWO_SIDED|95.0|0.68|1.03|||Log Rank||Unstratified analysis.|||1.03|0.68|0.0863
91600798|NCT01250379|183093145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0744|TWO_SIDED|95.0|0.65|1.02|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.02|0.65|0.0744
91600799|NCT01250379|183093145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0503|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Unstratified analysis.|||1.00|0.66|0.0503
91600800|NCT01250379|183093148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7253|TWO_SIDED|95.0|0.76|1.21|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.21|0.76|0.7253
91600801|NCT01250379|183093148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5332|TWO_SIDED|95.0|0.75|1.16|||Log Rank||Unstratified analysis.|||1.16|0.75|0.5332
91785398|NCT01024309|183451266|SUPERIORITY_OR_OTHER|||||||0.04||||||Apriori level of significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum was used||||||.04
91785399|NCT01024309|183451267|SUPERIORITY_OR_OTHER|||||||0.08||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test||||||0.08
91785400|NCT01024309|183451268|SUPERIORITY_OR_OTHER|||||||0.04||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.04
91785401|NCT01024309|183451269|SUPERIORITY_OR_OTHER|||||||0.22||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.22
91785402|NCT01024309|183451270|SUPERIORITY_OR_OTHER|||||||0.0029||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||.0029
91785403|NCT01024309|183451271|SUPERIORITY_OR_OTHER|||||||0.13||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.13
91785404|NCT01024309|183451272|SUPERIORITY_OR_OTHER|||||||0.29||||||a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum||||||0.29
91785405|NCT01024309|183451273|SUPERIORITY_OR_OTHER|||||||0.23||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.23
91785406|NCT01024309|183451274|SUPERIORITY_OR_OTHER|||||||0.49||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcox Rank Sum Test||||||0.49
91790492|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91785407|NCT01743001|183451275|SUPERIORITY||least-square (LS) mean difference|-4.7||||0.612|TWO_SIDED|95.0|-22.8|13.5||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically according to order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model included treatment group, presence of DS (yes/no), and WHO FC (II vs III/IV) as categorical factors, and baseline 6MWD value as covariate||The null hypothesis was that there was no difference between macitentan and placebo for the mean change from baseline to Week 16 in 6MWD. Null hypothesis was tested by an analysis of covariance (ANCOVA).||13.5|-22.8|0.6120
91600802|NCT01314716|183093166|SUPERIORITY_OR_OTHER||Differences in least squares mean|4.6||||0.011|TWO_SIDED|95.0|1.1|8.2||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||8.2|1.1|0.011
91600803|NCT01314716|183093167|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.1||||0.56|TWO_SIDED|95.0|-2.7|5.0||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.0|-2.7|0.56
91600804|NCT01327157|183093172|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors.|Mean Difference (Net)|0.5||||0.524|TWO_SIDED|||||Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results.|t-test, 1 sided|The comparison between the groups in each study period (initial) was done through the t-test for two independent samples.||"We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results"||||0.524
91600805|NCT01327157|183093173|EQUIVALENCE|"Only the treatment group was analysed. The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.~The models are made in the first and last query, after four visits with one month interval between them."|Mean Difference (Net)|5.0|STANDARD_DEVIATION|3.92|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The brand carbon mark was done on the treatment group in the first and last query.||||<0.001
91600806|NCT01327157|183093174|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors. The comparison among the groups, in each period of the study (initial and final) was done through t test for two independent samples.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|1.44||0.002|TWO_SIDED||||||t-test, 2 sided|||"We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p\<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results."||||0.002
91600807|NCT01327157|183093175|OTHER|||||||0.705|||||||t-test, 1 sided|||||||0.705
91600808|NCT01327157|183093176|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
91600809|NCT01928381|183093177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5695|TWO_SIDED|95.0|-0.34|0.61|||Mixed Models Analysis|||||0.61|-0.34|0.5695
91600810|NCT01928381|183093177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.23||0.8905|TWO_SIDED|95.0|-0.43|0.49|||Mixed Models Analysis|||||0.49|-0.43|0.8905
91650123|NCT03549130|183192609|SUPERIORITY||LS mean difference|-0.15||||0.4891|TWO_SIDED|95.0|-0.57|0.27||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.27|-0.57|0.4891
91790493|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.471|TWO_SIDED|95.0|-0.514|0.238||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.238|-0.514|0.471
91600811|NCT01928381|183093177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4822|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||||0.64|-0.30|0.4822
91600812|NCT01928381|183093178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2237|TWO_SIDED|95.0|-0.2|0.82|||Mixed Models Analysis||In direction of Pregabalin|||0.82|-0.20|0.2237
91600813|NCT01928381|183093178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.0978|TWO_SIDED|95.0|-0.93|0.08|||Mixed Models Analysis||In direction of Pregabain, positive control|||0.08|-0.93|0.0978
91790494|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91600814|NCT01928381|183093178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.661|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||||0.40|-0.62|0.6610
91600815|NCT01227902|183093191|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.1|52.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||52.9|27.1|
91600816|NCT01227902|183093191|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|19.1|44.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||44.9|19.1|
91600817|NCT01227902|183093191|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.2|64.8|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||64.8|35.2|
91600818|NCT01227902|183093191|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|43.3|70.5|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||70.5|43.3|
91790495|NCT02880956|183460066|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.198||0.604|TWO_SIDED|95.0|-0.493|0.287||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.287|-0.493|0.604
91650124|NCT03549130|183192609|SUPERIORITY||LS mean difference|-0.01||||0.9498|TWO_SIDED|95.0|-0.43|0.4||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.43|0.9498
91650125|NCT03549130|183192609|SUPERIORITY||LS mean difference|-0.36||||0.1235|TWO_SIDED|95.0|-0.83|0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.10|-0.83|0.1235
91650126|NCT03549130|183192610|SUPERIORITY|||||||0.8498||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.8498
91650127|NCT03549130|183192610|SUPERIORITY|||||||0.4652||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.4652
91650128|NCT03549130|183192610|SUPERIORITY|||||||0.439||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4390
91650129|NCT03549130|183192610|SUPERIORITY|||||||0.2997||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.2997
91650130|NCT03549130|183192610|SUPERIORITY|||||||0.1116||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.1116
91650131|NCT03549130|183192610|SUPERIORITY|||||||0.5101||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5101
91650132|NCT03549130|183192610|SUPERIORITY|||||||0.474||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.4740
91650133|NCT03549130|183192610|SUPERIORITY|||||||0.2787||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.2787
91650134|NCT03549130|183192611|SUPERIORITY|||||||0.5958||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.5958
91650135|NCT03549130|183192611|SUPERIORITY|||||||0.7296||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.7296
91650136|NCT03549130|183192611|SUPERIORITY|||||||0.7171||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.7171
91650137|NCT03549130|183192611|SUPERIORITY|||||||0.403||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4030
91650138|NCT03549130|183192611|SUPERIORITY|||||||0.4741||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.4741
91650139|NCT03549130|183192611|SUPERIORITY|||||||0.5591||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5591
91650140|NCT03549130|183192611|SUPERIORITY|||||||0.8285||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.8285
91650141|NCT03549130|183192611|SUPERIORITY|||||||0.3487||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3487
91650142|NCT01078623|183192612|SUPERIORITY_OR_OTHER||Least squares mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.174|0.268|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.268|0.174|<0.0001
91650143|NCT01078623|183192612|SUPERIORITY_OR_OTHER||Least squares mean difference|0.234|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.186|0.281|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.281|0.186|<0.0001
91650144|NCT00621686|183192641|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
91785408|NCT01743001|183451276|SUPERIORITY||Odds Ratio (OR)|0.53||||0.145|TWO_SIDED|95.0|0.23|1.24||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|Regression, Logistic|Logistic regression model adjusted for randomized treatment group and location of cardiac defect (pre-tricupsid / post-tricupsid ) as factors.||For this secondary endpoint of WHO functional class, the improvement from baseline to Week 16 in WHO functional class was evaluated. The null hypothesis is the odds of improvement are the same in the placebo and the macitentan group.||1.24|0.23|0.1450
91785409|NCT01743001|183451277|SUPERIORITY||least-square (LS) mean difference|0.08||||0.6818||95.0|-0.29|0.44||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|ANCOVA|Adjusted for randomized treatment group, location of cardiac defect(pre-tricupsid/post-tricupsid) as factors, baseline Borg dyspnea index as covariate||The null hypothesis was that the mean change from baseline to Week 16 in the Borg dyspnea index is the same in the macitentan and in the placebo group.||0.44|-0.29|0.6818
91785410|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-1.0||||0.6431|TWO_SIDED|95.0|-5.0|3.1|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning.||3.1|-5.0|0.6431
91600819|NCT01227902|183093191|SUPERIORITY_OR_OTHER||percentage of participants|44.5|||||TWO_SIDED|95.0|37.6|51.4|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||51.4|37.6|
91600820|NCT02363478|183093211|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of contractions, resting LES pressure and IRP between baseline and week 4.||||||<0.05
91600821|NCT02363478|183093214|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of heartburn, regurgitation, chest pain and dysphagia between baseline and week 4.||||||0.05
91600822|NCT00930059|183093216|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.73||0.3353|TWO_SIDED|90.0|-1.52|0.9||The primary test of significance was 1-sided, and a nominal Type I error rate a = 0.05 was employed.|ANCOVA|||Least squares (LS) mean difference and p-values were based on analysis of covariance (ANCOVA) on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.90|-1.52|0.3353
91600823|NCT00930059|183093217|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.72||0.6073|TWO_SIDED|90.0|-0.99|1.38||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.38|-0.99|0.6073
91600824|NCT00930059|183093217|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.73||0.3086|TWO_SIDED|90.0|-1.56|0.84||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.84|-1.56|0.3086
91600825|NCT00930059|183093217|SUPERIORITY||LS mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.73||0.197|TWO_SIDED|90.0|-1.82|0.58||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.58|-1.82|0.1970
91785411|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.5988|TWO_SIDED|95.0|-6.7|3.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical.||3.9|-6.7|0.5988
91600826|NCT00930059|183093218|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6547|TWO_SIDED|90.0|-0.18|0.29||No adjustments made for multiple comparisons.|Linear model|||Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.29|-0.18|0.6547
91600827|NCT00930059|183093218|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.702|TWO_SIDED|90.0|-0.16|0.31||No adjustments made for multiple comparisons.|Linear model|||Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.31|-0.16|0.7020
91600828|NCT00930059|183093218|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.1138|TWO_SIDED|90.0|-0.41|0.06||No adjustments made for multiple comparisons.|Linear model|||Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.06|-0.41|0.1138
91650145|NCT01797120|183192650|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.4|0.92|||Log Rank|Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease||||0.92|0.40|0.02
91790496|NCT02880956|183460066|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91600829|NCT00930059|183093218|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.0816|TWO_SIDED|90.0|-0.44|0.04||No adjustments made for multiple comparisons.|Linear model|||Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.04|-0.44|0.0816
91600830|NCT00930059|183093220|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.96||0.7634|TWO_SIDED|90.0|-0.89|2.27||No adjustments have been made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.27|-0.89|0.7634
91650146|NCT01797120|183192651|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
91650147|NCT01797120|183192652|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
91522644|NCT01951638|182920303|OTHER||Mean Difference (Net)|1.219|||=|0.7241|TWO_SIDED|95.0|-2.82|5.26|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.26|-2.82|= 0.7241
91600831|NCT00930059|183093220|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|0.97||0.8077|TWO_SIDED|90.0|-0.75|2.45||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.45|-0.75|0.8077
91600832|NCT00930059|183093220|SUPERIORITY||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.98||0.835|TWO_SIDED|90.0|-0.66|2.57||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.57|-0.66|0.8350
91600833|NCT00930059|183093220|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.99||0.4377|TWO_SIDED|90.0|-1.78|1.48||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 12: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.48|-1.78|0.4377
91600834|NCT01916980|183093287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis group||||<0.001
91650148|NCT00992264|183192672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.51|1.51|||||OR for smoking abstinence at 12 months in intent to treat sample. Participants receiving content written in a Prescriptive tone were compared against persons receiving content in a Motivational tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.51|0.51|
91785412|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-5.9|6.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index.||6.2|-5.9|0.9642
91785413|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|3.1||||0.1542|TWO_SIDED|95.0|-1.2|7.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions.||7.3|-1.2|0.1542
91522645|NCT01951638|182920303|OTHER||Mean Difference (Net)|1.198|||=|0.7546|TWO_SIDED|95.0|-2.23|4.63|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||4.63|-2.23|= 0.7546
91522646|NCT01338025|182920308|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
91522647|NCT03188055|182920312|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91522648|NCT03188055|182920313|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
91522649|NCT03188055|182920314|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91522650|NCT03188055|182920315|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
91522651|NCT03188055|182920316|SUPERIORITY|||||||0.892|||||||t-test, 2 sided|||||||0.892
91522652|NCT03188055|182920317|SUPERIORITY||||||>|0.99||||||Using an a priori statistical significance of 0.05.|Fisher Exact|||Comparison of concordance status by intervention status (outcome by predictor).||||> . 99
91522653|NCT03188055|182920318|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||||||0.188
91522654|NCT03188055|182920319|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
91600835|NCT01916980|183093287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus group||||<0.001
91785414|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|1.1||||0.602|TWO_SIDED|95.0|-3.1|5.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality.||5.3|-3.1|0.6020
91522655|NCT03188055|182920321|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
91522656|NCT03188055|182920322|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91522657|NCT00201864|182920413|SUPERIORITY_OR_OTHER|||||||0.9102|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9102
91522658|NCT01782742|182920415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided|||||0.03|-0.13|0.22
91522659|NCT01782742|182920416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.57|TWO_SIDED|95.0|-4.428|2.428|||t-test, 2 sided|||||2.428|-4.428|0.57
91522660|NCT01782742|182920417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.625||||0.83|TWO_SIDED|95.0|-5.029|6.279|||t-test, 2 sided|||||6.279|-5.029|0.83
91522661|NCT01782742|182920418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.000|0.000|
91522662|NCT01782742|182920419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375||||0.94|TWO_SIDED|95.0|-9.674|8.924|||t-test, 2 sided|||||8.924|-9.674|0.94
91522663|NCT01782742|182920420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.563||||0.18|TWO_SIDED|95.0|-1.975|11.1|||t-test, 2 sided|||||11.100|-1.975|0.18
91522664|NCT01782742|182920428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.46|TWO_SIDED|95.0|-0.01|0.021|||t-test, 2 sided|||||0.021|-0.010|0.46
91600836|NCT00741156|183093316|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
91600837|NCT01815229|183093318|OTHER||||||<|0.05||||||P value applies to cell count at removal|t-test, 2 sided|||Tracheal lavages (TL) were done in intubated humans to obtain cell counts.||||<0.05
91600838|NCT01394705|183093346|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||.65
91785415|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.634|TWO_SIDED|95.0|-7.2|4.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning.||4.4|-7.2|0.6340
91785416|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-2.8||||0.3384|TWO_SIDED|95.0|-8.7|3.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional.||3.0|-8.7|0.3384
91785417|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-2.3||||0.2704|TWO_SIDED|95.0|-6.4|1.8|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.8|-6.4|0.2704
91600839|NCT01394705|183093346|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91600840|NCT01394705|183093347|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91600841|NCT02167945|183093375|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91600842|NCT02167945|183093375|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
91600843|NCT02167945|183093376|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91785418|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-0.4||||0.6431|TWO_SIDED|95.0|-2.1|1.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning (norm-based).||1.3|-2.1|0.6431
91785419|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.5988|TWO_SIDED|95.0|-2.6|1.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical (norm-based).||1.5|-2.6|0.5988
91785420|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-2.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index (norm-based).||2.6|-2.5|0.9642
91613672|NCT02078713|183121552|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of uncertainty subscale of DCS||2.05|1.03|0.03
91613673|NCT02078713|183121552|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5|TWO_SIDED|95.0|0.8|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of effective decision subscale||1.59|0.80|0.5
91613674|NCT02078713|183121552|SUPERIORITY||Odds Ratio (OR)|1.17||||0.31|TWO_SIDED|95.0|0.86|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of values clarity subscale||1.59|0.86|0.31
91613675|NCT02078713|183121552|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.76|1.49||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of support subscale||1.49|0.76|0.73
91613676|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.72||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pills are more effective than condoms||1.72|0.94|0.12
91600844|NCT02167945|183093376|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
91600845|NCT02167945|183093377|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91600846|NCT02167945|183093377|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
91600847|NCT02167945|183093378|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
91600848|NCT02167945|183093378|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
91785421|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|1.5||||0.1542|TWO_SIDED|95.0|-0.6|3.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions (norm-based).||3.5|-0.6|0.1542
91785422|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|0.6||||0.602|TWO_SIDED|95.0|-1.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality (norm-based).||2.6|-1.5|0.6020
91785423|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.634|TWO_SIDED|95.0|-3.1|1.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning (norm-based).||1.9|-3.1|0.6340
91785424|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.3384|TWO_SIDED|95.0|-4.1|1.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional (norm-based).||1.4|-4.1|0.3384
91785425|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.2704|TWO_SIDED|95.0|-3.6|1.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.0|-3.6|0.2704
91785426|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|0.7||||0.4332|TWO_SIDED|95.0|-1.0|2.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Physical Component Summary Score.||2.3|-1.0|0.4332
91785427|NCT01743001|183451278|SUPERIORITY||least-square (LS) mean difference|-1.1||||0.3416|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Mental Component Summary Score.||1.2|-3.4|0.3416
91785428|NCT02657408|183451281|EQUIVALENCE|confirmatory statistical hypothesis tested|Geometric mean ratio (%)|1.27||||0.3043|TWO_SIDED|90.0|0.86|1.87|||ANOVA|||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.87|0.86|0.3043
91785429|NCT02657408|183451282|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.01|||||TWO_SIDED|90.0|0.88|1.16||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.16|0.88|
91785430|NCT02657408|183451283|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.54|||||TWO_SIDED|90.0|0.59|4.03||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||4.03|0.59|
91785431|NCT02657408|183451284|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.17|||||TWO_SIDED|90.0|0.49|2.85||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||2.85|0.49|
91600849|NCT02167945|183093379|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
91785432|NCT02657408|183451285|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.29|||||TWO_SIDED|90.0|0.91|1.83||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.83|0.91|
91785433|NCT02657408|183451286|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.03|||||TWO_SIDED|90.0|0.9|1.18||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.18|0.90|
91600850|NCT02167945|183093379|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
91600851|NCT02167945|183093380|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91600852|NCT02167945|183093380|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
91600853|NCT02167945|183093382|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.79||0.026|TWO_SIDED|95.0|-3.3|-0.21|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.21|-3.30|0.026
91600854|NCT02167945|183093382|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|95.0|-1.97|0.91|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.91|-1.97|0.472
91600855|NCT02167945|183093382|SUPERIORITY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.73||0.159|TWO_SIDED|95.0|-2.47|0.4|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.40|-2.47|0.159
91600856|NCT02167945|183093382|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.84||0.125|TWO_SIDED|95.0|-2.95|0.36|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.36|-2.95|0.125
91650149|NCT00992264|183192672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.66|1.91|||||OR for smoking abstinence at 12 months when persons who randomly received a Testimonial were compared against persons receiving No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.91|0.66|
91785434|NCT02657408|183451287|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.18|||||TWO_SIDED|90.0|0.91|1.53||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.53|0.91|
91785435|NCT02657408|183451288|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.94|||||TWO_SIDED|90.0|0.8|1.09||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.09|0.80|
91785436|NCT02657408|183451289|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.81|||||TWO_SIDED|90.0|0.51|1.28||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.28|0.51|
91600857|NCT02167945|183093382|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.78||0.756|TWO_SIDED|95.0|-1.78|1.29|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.29|-1.78|0.756
91600858|NCT02167945|183093382|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.78||0.315|TWO_SIDED|95.0|-2.32|0.75|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-2.32|0.315
91600859|NCT02167945|183093383|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.03||0.216|TWO_SIDED|95.0|-3.3|0.75|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-3.30|0.216
91600860|NCT02167945|183093383|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.95||0.074|TWO_SIDED|95.0|-3.58|0.17|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.17|-3.58|0.074
91600861|NCT02167945|183093383|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.056|TWO_SIDED|95.0|-3.67|0.05|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.05|-3.67|0.056
91600862|NCT02167945|183093383|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.02||0.411|TWO_SIDED|95.0|-2.84|1.16|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.16|-2.84|0.411
91600863|NCT02167945|183093383|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.93||0.065|TWO_SIDED|95.0|-3.55|0.11|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.11|-3.55|0.065
91600864|NCT02167945|183093383|SUPERIORITY||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.93||0.026|TWO_SIDED|95.0|-3.91|-0.25|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 24||-0.25|-3.91|0.026
91600865|NCT02167945|183093384|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.95||0.035|TWO_SIDED|95.0|-3.86|-0.14|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes (PRO) score and SVR12 status as covariates."||-0.14|-3.86|0.035
91600866|NCT02167945|183093384|SUPERIORITY||LS Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.88||0.015|TWO_SIDED|95.0|-3.88|-0.42|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.42|-3.88|0.015
91600867|NCT02167945|183093384|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.88||0.048|TWO_SIDED|95.0|-3.46|-0.01|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 12||-0.01|-3.46|0.048
91600868|NCT02167945|183093384|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.99||0.466|TWO_SIDED|95.0|-2.67|1.22|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.22|-2.67|0.466
91600869|NCT02167945|183093384|SUPERIORITY||LS Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.91||0.035|TWO_SIDED|95.0|-3.7|-0.13|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.13|-3.70|0.035
91600870|NCT02167945|183093384|SUPERIORITY||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|0.91||0.015|TWO_SIDED|95.0|-4.01|-0.43|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.43|-4.01|0.015
91600871|NCT02623335|183093394|SUPERIORITY||Odds Ratio (OR)|1.32||||0.353|TWO_SIDED||||||Mixed Models Analysis|||Options questions||||0.353
91600872|NCT02623335|183093394|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED||||||Mixed Models Analysis|||Expectations questions||||0.923
91785437|NCT02657408|183451290|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.64|||||TWO_SIDED|90.0|0.43|0.97||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||0.97|0.43|
91785438|NCT05498701|183451300|OTHER||Ratios of Adjusted Geometric Means|93.19|||||TWO_SIDED|90.0|87.1|99.7||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis AUCinf fell entirely within the acceptance region of (80%,125%).||99.70|87.10|
91600873|NCT02623335|183093394|SUPERIORITY||Odds Ratio (OR)|1.41||||0.255|TWO_SIDED||||||Mixed Models Analysis|||Risks questions||||0.255
91600874|NCT02623335|183093394|SUPERIORITY||Odds Ratio (OR)|239047259.0||||0.094|TWO_SIDED||||||Mixed Models Analysis|||Advance directives questions||||0.094
91600875|NCT02623335|183093395|SUPERIORITY||Effect estimate|-0.04||||0.84|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T2 and T1||||0.84
91600876|NCT02623335|183093395|SUPERIORITY||Effect estimate|-0.15||||0.645|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T3 and T1||||0.645
91600877|NCT02623335|183093396|SUPERIORITY||Effect estimate|-0.37||||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
91600878|NCT02623335|183093397|SUPERIORITY||Odds Ratio (OR)|1.39||||0.412|TWO_SIDED||||||Mixed Models Analysis|||||||0.412
91600879|NCT02623335|183093398|SUPERIORITY||Effect estimate|-0.25||||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
91600880|NCT02623335|183093399|SUPERIORITY||Effect estimate|-0.72||||0.106|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.106
91600881|NCT02623335|183093399|SUPERIORITY||Effect estimate|-1.12||||0.007|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.007
91600882|NCT02623335|183093400|SUPERIORITY||Effect estimate|0.97||||0.034|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.034
91600883|NCT02623335|183093400|SUPERIORITY||Effect estimate|1.12||||0.019|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment (T3)||||0.019
91600884|NCT02623335|183093401|SUPERIORITY||Effect estimate|1.16||||0.022|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.022
91600885|NCT02623335|183093401|SUPERIORITY||Effect estimate|0.94||||0.053|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.053
91600886|NCT02623335|183093403|SUPERIORITY||Effect estimate|5.04||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
91600887|NCT03285243|183093404|OTHER|||||||0.001||||||A priori, All p-values \< 0.05 were considered statistically significant.|Chi-squared|||||||0.001
91600888|NCT03285243|183093405|OTHER|||||||0.002||||||a priori, all p-values \< 0.05 were considered statistically significant.|Regression, Logistic|||||||0.002
91600889|NCT03175549|183093415|SUPERIORITY||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|10.1||0.36|TWO_SIDED|95.0|-10.22|29.38||A priori threshold for significance was 0.05.|Mixed Models Analysis||Standard error was calculated using bootstrap methods which is considered best for MEM.|||29.38|-10.22|0.36
91600890|NCT03175549|183093416|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03|<|0.025|TWO_SIDED||||||t-test, 2 sided|||Posted results show mean change in drinking for the drug group relative to placebo for each day of the 11 days of ad libidum drinking (Days 1-11) permitted during the 14 days (2 weeks) of medication.||||<0.025
91600891|NCT03175549|183093416|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03||0.025|TWO_SIDED||||||Mixed Models Analysis|473 daily observations within 43 individuals.|The apremilast group showed a significantly more rapid reduction in drinks per day relative to placebo.|||||0.025
91600892|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-79.456|STANDARD_ERROR_OF_MEAN|0.0819|<|0.0001|TWO_SIDED|80.0|-81.56|-77.11|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.11|-81.56|<0.0001
91600893|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-87.403|STANDARD_ERROR_OF_MEAN|0.0887|<|0.0001|TWO_SIDED|80.0|-88.8|-85.84|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-85.84|-88.80|<0.0001
91785439|NCT05498701|183451301|OTHER||Ratio of Adjusted Geometric Means|81.0||||||90.0|76.25|86.04||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis Cmax fell entirely within the acceptance region of (80%,125%).||86.04|76.25|
91785440|NCT01864005|183451302|SUPERIORITY_OR_OTHER|||||||0.0021||||||not adjusted for multiple comparisons. statistical significance level: 0.05|Wilcoxon (Mann-Whitney)|||||||0.0021
91600894|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-83.83|STANDARD_ERROR_OF_MEAN|0.0905|<|0.0001|TWO_SIDED|80.0|-85.65|-81.78|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.78|-85.65|<0.0001
91600895|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-92.138|STANDARD_ERROR_OF_MEAN|0.1041|<|0.0001|TWO_SIDED|80.0|-93.15|-90.98|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-90.98|-93.15|<0.0001
91600896|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-84.814|STANDARD_ERROR_OF_MEAN|0.0971|<|0.0001|TWO_SIDED|80.0|-86.64|-82.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-82.74|-86.64|<0.0001
91600897|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-92.87|STANDARD_ERROR_OF_MEAN|0.1114|<|0.0001|TWO_SIDED|80.0|-93.85|-91.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-91.74|-93.85|<0.0001
91600898|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-79.465|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|80.0|-81.69|-76.96|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.96|-81.69|<0.0001
91600899|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-88.711|STANDARD_ERROR_OF_MEAN|0.0963|<|0.0001|TWO_SIDED|80.0|-90.06|-87.18|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-87.18|-90.06|<0.0001
91600900|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-78.936|STANDARD_ERROR_OF_MEAN|0.0824|<|0.0001|TWO_SIDED|80.0|-81.11|-76.52|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.52|-81.11|<0.0001
91785441|NCT01864005|183451302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.421||||0.0003|TWO_SIDED|95.0|18.559|58.283|||ANOVA|||||58.283|18.559|0.0003
91785442|NCT01864005|183451303|SUPERIORITY_OR_OTHER|||||||0.0828|||||||Wilcoxon (Mann-Whitney)|||||||0.0828
91785443|NCT01864005|183451304|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91785444|NCT01864005|183451305|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91785445|NCT01864005|183451306|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91785446|NCT02184572|183451309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.|Difference in incidence of fever|1.11|||||TWO_SIDED|95.0|-0.93|2.89||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 39.0°C.||2.89|-0.93|
91785447|NCT02184572|183451309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.|Difference in incidence of fever|1.09|||||TWO_SIDED|95.0|-2.89|4.85||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 38.0°C.||4.85|-2.89|
91785448|NCT00763698|183451330|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|95.0|5.0||||Kaplan-Meier Survival Analysis|||The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.|||5|
91785449|NCT00763698|183451331|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|97.5|2.5||||Wilson score interval method||||||2.5|
91785450|NCT03679754|183451360|OTHER||||||||||||||||||Subjects in the Expansion trial did not have biopsies analyzed for cellular responses.|||
91785451|NCT01247272|183451370|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|113.36|||||TWO_SIDED|90.0|108.03|118.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||118.96|108.03|
91785452|NCT01247272|183451371|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.78|||||TWO_SIDED|90.0|102.18|113.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.69|102.18|
91785453|NCT01247272|183451372|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.99|||||TWO_SIDED|90.0|102.09|112.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.12|102.09|
91785454|NCT01247272|183451373|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.57|||||TWO_SIDED|90.0|99.54|107.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.76|99.54|
91785455|NCT01247272|183451374|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|101.66|110.12|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.12|101.66|
91785456|NCT01247272|183451375|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.83|||||TWO_SIDED|90.0|101.27|110.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.61|101.27|
91785457|NCT00711477|183451445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.5|0.9||||||||0.90|0.50|
91785458|NCT00711477|183451446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.38|TWO_SIDED|95.0|-1.83|0.72|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.72|-1.83|0.380
91785459|NCT00711477|183451447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.744|TWO_SIDED|95.0|-2.87|2.07|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||2.07|-2.87|0.744
91785460|NCT00711477|183451448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.139|TWO_SIDED|95.0|-3.84|0.56|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.56|-3.84|0.139
91785461|NCT00711477|183451449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.094|TWO_SIDED|95.0|-2.96|0.24|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.24|-2.96|0.094
91785462|NCT00711477|183451450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.102|TWO_SIDED|95.0|-5.48|0.51|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.51|-5.48|0.102
91785463|NCT00711477|183451451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4||||0.16||95.0|-22.7|3.89|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||3.89|-22.7|0.160
91785464|NCT00711477|183451452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|90.0|0.4|0.8||||||||0.80|0.40|
91600901|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-86.28|STANDARD_ERROR_OF_MEAN|0.0899|<|0.0001|TWO_SIDED|80.0|-87.82|-84.55|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.55|-87.82|<0.0001
91785465|NCT00711477|183451453|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|0.5|1.0||||||||1.00|0.50|
91785466|NCT00711477|183451454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||||TWO_SIDED|90.0|0.74|1.24||||||||1.24|0.74|
91785467|NCT00711477|183451455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|90.0|0.95|1.65||||||||1.65|0.95|
91785468|NCT00711477|183451456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|90.0|0.31|0.57||||||||0.57|0.31|
91785469|NCT01400880|183451457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_DEVIATION|3.28|||TWO_SIDED|95.0|1.7|4.27||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.27|1.70|
91600902|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-79.648|STANDARD_ERROR_OF_MEAN|0.0664|<|0.0001|TWO_SIDED|80.0|-81.36|-77.78|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.78|-81.36|<0.0001
91600903|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-84.985|STANDARD_ERROR_OF_MEAN|0.0715|<|0.0001|TWO_SIDED|80.0|-86.34|-83.5|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-83.50|-86.34|<0.0001
91600904|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|72.893|STANDARD_ERROR_OF_MEAN|0.0809|<|0.0001|TWO_SIDED|80.0|55.37|92.4|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||92.40|55.37|<0.0001
91600905|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|98.049|STANDARD_ERROR_OF_MEAN|0.0897|<|0.0001|TWO_SIDED|80.0|75.92|122.96|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||122.96|75.92|<0.0001
91600906|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-80.164|STANDARD_ERROR_OF_MEAN|0.0668|<|0.0001|TWO_SIDED|80.0|-81.84|-78.33|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-78.33|-81.84|<0.0001
91600907|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-83.381|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|80.0|-84.92|-81.69|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.69|-84.92|<0.0001
91600908|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-78.408|STANDARD_ERROR_OF_MEAN|0.0602|<|0.0001|TWO_SIDED|80.0|-80.06|-76.62|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate||-76.62|-80.06|<0.0001
91600909|NCT02793232|183093465|SUPERIORITY||Percent change from baseline|-85.365|STANDARD_ERROR_OF_MEAN|0.0653|<|0.0001|TWO_SIDED|80.0|-86.57|-84.05|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.05|-86.57|<0.0001
91600910|NCT01064167|183093473|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.||||<0.05
91600911|NCT01064167|183093474|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91600912|NCT02301403|183093514|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.69|5.14|||Regression, Logistic|||||5.14|1.69|<.001
91600913|NCT01128829|183093515|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 2 sided|||Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).||||0.025
91600914|NCT01060059|183093532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.831|TWO_SIDED|95.0|0.62|1.46|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.46|0.62|0.831
91600915|NCT01060059|183093532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.554|TWO_SIDED|95.0|0.74|1.76||Baseline Medical conditions (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||1.76|0.74|0.554
91613677|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.0001|TWO_SIDED|95.0|1.94|3.62||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are more effective than pills||3.62|1.94|<0.0001
91522665|NCT01782742|182920429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|||||0.040|-0.020|0.53
91613678|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - depo is more effective than condoms||2.44|1.29|0.0004
91600916|NCT01060059|183093532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.714|TWO_SIDED|95.0|0.43|3.42||Baseline gastrointestinal symptoms (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||3.42|0.43|0.714
91785470|NCT01400880|183451457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|2.98|4.92||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.92|2.98|
91785471|NCT02695420|183451466|SUPERIORITY||Treatment Difference|22.1|STANDARD_ERROR_OF_MEAN|6.3||0.0008|TWO_SIDED|95.0|9.6|34.7|||Repeated Measures Model|||||34.7|9.6|0.0008
91785472|NCT02695420|183451466|SUPERIORITY||Treatment Difference|29.3|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|16.3|42.3|||Repeated measures model|||||42.3|16.3|< 0.0001
91785473|NCT02695420|183451466|SUPERIORITY||Treatment Difference|25.5|STANDARD_ERROR_OF_MEAN|6.5||0.0002|TWO_SIDED|95.0|12.6|38.4|||Repeated measures model|||||38.4|12.6|0.0002
91785474|NCT02448641|183451468|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6743|TWO_SIDED|95.0|0.35|5.09||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.09|0.35|0.6743
91785475|NCT02448641|183451469|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1|TWO_SIDED|95.0|0.15|1.18||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with mRS responder as outcome, treatment, visit, treatment-visit interaction, pooled site and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||1.18|0.15|0.1000
91785476|NCT02448641|183451472|SUPERIORITY||Mean Difference (Net)|-0.36||||0.7788|TWO_SIDED|95.0|-2.9|2.17||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): -0.36 (1.283)|Statistical analysis: NeuroQOL score for the Upper Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.17|-2.90|0.7788
91785477|NCT02448641|183451472|SUPERIORITY||Mean Difference (Net)|0.58||||0.5347|TWO_SIDED|95.0|-1.26|2.43||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 0.58 (0.934)|Statistical Analysis: NeuroQOL score for Lower Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.43|-1.26|0.5347
91785478|NCT02448641|183451474|SUPERIORITY||Mean Difference (Net)|1.2||||0.2959|TWO_SIDED|95.0|-1.1|3.6||MMRM: Mixed effect Model Repeat Measurement|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 1.2 (1.18)|"Change from Baseline at Month 6~Between-group Effect size is calculated as the LS mean difference divided by the model estimate of the pooled SD, obtained from the square root of the diagonal element, associated with the analysis visit summarized, from the covariance matrix."||3.6|-1.1|0.2959
91600917|NCT01060059|183093533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.001|TWO_SIDED|95.0|0.6|0.78|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.78|0.60|<0.001
91600918|NCT01060059|183093534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.055|TWO_SIDED|95.0|0.96|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.96|0.055
91650150|NCT00992264|183192672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.02|||||OR for smoking abstinence at 12 months when persons assigned to Dictated navigation were compared to those not assigned to Dictated navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||2.02|0.70|
91785479|NCT02448641|183451475|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6854|TWO_SIDED|95.0|0.31|5.92||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.92|0.31|0.6854
91785480|NCT00916929|183451476|SUPERIORITY_OR_OTHER||rate per patient year of follow up|1.5||||||95.0|||||exact method|95% Upper Confidence Limit of objective performance criteria||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate \<1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up."||||
91790497|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.069||0.325|TWO_SIDED|95.0|-0.067|0.202||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.202|-0.067|0.325
91600919|NCT01060059|183093535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||<|0.001|TWO_SIDED|95.0|0.95|0.99|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.99|0.95|<0.001
91600920|NCT01060059|183093536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.001|TWO_SIDED|95.0|1.15|1.23|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher BMI (1 kg/m\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.23|1.15|<0.001
91600921|NCT01060059|183093537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.026|TWO_SIDED|95.0|1.0|1.05|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.05|1.00|0.026
91600922|NCT01060059|183093538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.77|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.77|0.18|0.007
91600923|NCT01060059|183093538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.094|TWO_SIDED|95.0|0.97|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.97|0.094
91650151|NCT00992264|183192672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.43|1.3|||||OR for smoking abstinence at 12 months when persons assigned to receive Proactive Email reminders were compared against persons who received No Emails (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.30|0.43|
91650152|NCT00992264|183192673|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.62|1.43|||||OR for use of adjunct treatment at 12 months when persons assigned to Prescriptive Tone were compared to persons assigned to receive content in a Motivational Tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.43|0.62|
91650153|NCT00992264|183192673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.07|||||OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.07|0.46|
91650154|NCT00992264|183192673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.18|||||OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||1.18|0.51|
91650155|NCT00992264|183192673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.03|0.44|
91600924|NCT01060059|183093538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.259|TWO_SIDED|95.0|1.0|1.01|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.01|1.00|0.259
91600925|NCT01060059|183093538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.123|TWO_SIDED|95.0|1.0|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|1.00|0.123
91600926|NCT02302963|183093539|OTHER|Analysis of Variance|||||<|0.001|||||||GLM Repeated Measures|Repeated-measures general linear model was used to compare HCLC versus SAP data. A P-value of \< 0.001 was considered the threshold for significance.||||||<0.001
91600927|NCT01920711|183093544|SUPERIORITY||Rate Ratio|0.8698||||0.0587|TWO_SIDED|95.0|0.7526|1.0052||1-sided p-value 0.0294|Proportional Rates Model (LWYY)|Treatment as fixed-effect factor and stratified by region and with robust variance estimate.||Primary Composite Events||1.0052|0.7526|0.0587
91600928|NCT01920711|183093544|SUPERIORITY||Rate Ratio|0.8511||||0.0556|TWO_SIDED|95.0|0.7216|1.0039||1-sided p-value 0.0278|Joint Frality Model|Treatment and region as fixed-effect factors||Total Hospitalizations for heart failure||1.0039|0.7216|0.0556
91600929|NCT01920711|183093544|SUPERIORITY||Hazard Ratio (HR)|0.9531||||0.6241|TWO_SIDED|95.0|0.7863|1.1551||1-sided p-value 0.3120|Cox's proportional hazard model|||Cardiovascular Death||1.1551|0.7863|0.6241
91600930|NCT01920711|183093545|SUPERIORITY||Least Squares Mean of Difference|1.0264||||0.051|TWO_SIDED|95.0|-0.0047|2.0576|||Mixed Models Analysis|||Clinical Summary Score||2.0576|-0.0047|0.0510
91600931|NCT01920711|183093546|SUPERIORITY||Odds Ratio (OR)|1.4475||||0.0035|TWO_SIDED|95.0|1.1294|1.8552|||Repeated measures cumulative odds model|The response variable is the change from baseline to any scheduled time points up to Month 8.||NYHA Class Change||1.8552|1.1294|0.0035
91600932|NCT01920711|183093547|SUPERIORITY||Hazard Ratio (HR)|0.5041||||0.0014|TWO_SIDED|95.0|0.3312|0.7673|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Composite renal endpoint||0.7673|0.3312|0.0014
91600933|NCT01920711|183093547|SUPERIORITY||Hazard Ratio (HR)|0.9295||||0.9588|TWO_SIDED|95.0|0.0581|14.861|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Renal Death||14.861|0.0581|0.9588
91600934|NCT01920711|183093547|SUPERIORITY||Hazard Ratio (HR)|0.5774||||0.2484|TWO_SIDED|95.0|0.2272|1.4672|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Reaching ESRD||1.4672|0.2272|0.2484
91600935|NCT01920711|183093547|SUPERIORITY||Hazard Ratio (HR)|0.4407||||0.0004|TWO_SIDED|95.0|0.2798|0.6942|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||\>=50% decline in eGFR from baseline||0.6942|0.2798|0.0004
91600936|NCT01920711|183093548|SUPERIORITY||Hazard Ratio (HR)|0.9696||||0.6846|TWO_SIDED|95.0|0.8352|1.1255|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||All-cause mortality||1.1255|0.8352|0.6846
91600937|NCT06033079|183093667|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.32|2.95||||||||2.95|0.32|
91650156|NCT00909727|183192674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|6.6|18.3||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline value of percent predicted FEV1.||18.3|6.6|<0.0001
91785481|NCT00916929|183451477|SUPERIORITY_OR_OTHER||sensitivity|50.0|STANDARD_ERROR_OF_MEAN|5.0|||ONE_SIDED|95.0|50.0||||exact method|||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity \> 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%."|||50|
91600938|NCT06033079|183093668|SUPERIORITY|||||||0.233|||||||Fisher Exact|||||||0.233
91600939|NCT06033079|183093669|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.3|2.37||||||||2.37|0.30|
91600940|NCT06033079|183093670|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.32|1.82||||||||1.82|0.32|
91600941|NCT06033079|183093671|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.34|7.51||||||||7.51|0.34|
91600942|NCT06033079|183093672|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.13|1.42||||||||1.42|0.13|
91600943|NCT06033079|183093673|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.41|7.9||||||||7.90|0.41|
91600944|NCT04202679|183093678|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0216|TWO_SIDED|95.0|1.08|5.0||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||5.00|1.08|0.0216
91600945|NCT04202679|183093679|SUPERIORITY||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.56|22.66||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.66|3.56|<0.0001
91600946|NCT04202679|183093680|SUPERIORITY||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.02|9.55||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||9.55|2.02|<0.0001
91785482|NCT04530136|183451506|SUPERIORITY|||||||0.0346|||||||Wilcoxon rank test|||||||0.0346
91785483|NCT04530136|183451507|SUPERIORITY|||||||0.4441|||||||WHO Ordinal Scale|||||||0.4441
91600947|NCT04202679|183093681|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0001|TWO_SIDED|95.0|2.03|18.11||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05||18.11|2.03|0.0001
91785484|NCT04530136|183451508|SUPERIORITY|||||||0.1021|||||||WHO Ordinal Scale for Clin Improvement|||||||0.1021
91650157|NCT00909727|183192675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.7||0.0006|TWO_SIDED|95.0|4.5|15.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. no imputation of missing data was done.||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM). Estimates were obtained from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit \& treatment group, \& adjustment for the continuous baseline value of percent predicted FEV1, using unstructured covariance matrix.||15.5|4.5|0.0006
91785485|NCT04530136|183451509|SUPERIORITY|||||||0.1615|||||||WHO Ordinal Scale|||||||0.1615
91785486|NCT01309282|183451510|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
91522666|NCT04425902|182920445|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.94|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.94|
91522667|NCT04425902|182920446|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.95|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.95|
91785487|NCT01309282|183451511|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
91785488|NCT01309282|183451512|SUPERIORITY_OR_OTHER|||||||0.01403|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.01403
91785489|NCT01309282|183451513|SUPERIORITY_OR_OTHER|||||||0.0355|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0355
91785490|NCT01309282|183451514|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.5469
91785491|NCT01309282|183451515|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
91785492|NCT01309282|183451516|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
91785493|NCT01309282|183451517|SUPERIORITY_OR_OTHER|||||||0.0904|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0904
91785494|NCT01309282|183451518|SUPERIORITY_OR_OTHER|||||||0.2969|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2969
91785495|NCT02692391|183451524|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91785496|NCT02692391|183451525|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91785497|NCT02692391|183451526|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
91785498|NCT02692391|183451527|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91785499|NCT01136785|183451531|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||two-sided t test for the change from baseline between the treated and untreated groups.||||0.01
91785500|NCT01136785|183451532|SUPERIORITY_OR_OTHER|||||||0.011|||||||2-sided Paired t-test|||comparing pre and post Interstitial Glucose levels in the active CPAP group||||0.011
91785501|NCT01136785|183451533|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
91785502|NCT01136785|183451534|SUPERIORITY_OR_OTHER|||||||0.754|||||||two-sided paired t-test|||Plasma cortisol pre and post 1-week of active CPAP||||0.754
91785503|NCT01136785|183451535|SUPERIORITY_OR_OTHER|||||||0.308|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.308
91785504|NCT01136785|183451536|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.036
91785505|NCT00612807|183451540|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|-0.56|STANDARD_ERROR_OF_MEAN|0.29||0.056||95.0||||Interaction indicates that slope of change varied by identified patient status and tx condition. Slope of change in depression was significantly negative for everyone but identified patients in the control condition.|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.056
91785506|NCT00612807|183451541|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|0.64|STANDARD_ERROR_OF_MEAN|0.65||0.32||95.0|||||Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.32
91785507|NCT00612807|183451541|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether means at each timepoint varied by identified patient status and treatment condition.|Interaction term|-12.97|STANDARD_ERROR_OF_MEAN|4.52||0.005||95.0||||We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006).|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.005
91785508|NCT03818035|183451570|NON_INFERIORITY|One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results are reported.|Risk Difference (RD)|-0.6||||0.0013|TWO_SIDED|90.0|-5.7|4.5|||Wald Z-test|||||4.5|-5.7|0.0013
91785509|NCT01043939|183451594|SUPERIORITY_OR_OTHER||Difference of least square means|-0.16||||0.25|TWO_SIDED|95.0|-0.42|0.11||24 participants required to achieve 80% power to detect mean difference of 0.3 in RH-PAT index score between juice groups, assuming standard deviation of the difference was 0.25, using a two-sided significance level of 0.05|Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|The a priori threshold for statistical significance was 0.05.|||0.11|-0.42|0.25
91785510|NCT01043939|183451595|SUPERIORITY_OR_OTHER||Difference of least square means|3.09||||0.29|TWO_SIDED|95.0|-2.73|8.91|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.||||8.91|-2.73|0.29
91785511|NCT01043939|183451596|SUPERIORITY_OR_OTHER||Ratio of means|0.92||||0.15|TWO_SIDED|95.0|0.82|1.03|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|MPO was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||1.03|0.82|0.15
91785512|NCT01043939|183451597|SUPERIORITY_OR_OTHER||Ratio of means|1.34||||0.37|TWO_SIDED|95.0|0.69|2.62|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|hs-CRP was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||2.62|0.69|0.37
91785513|NCT00281658|183451607|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0062|TWO_SIDED|95.0|0.58|0.94||Stratified Log-Rank (one-sided)|Log Rank||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Primary OS analysis cut-off date = 18-Jun-2010||0.94|0.58|0.0062
91785514|NCT00281658|183451608|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.64|0.98|||||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Final OS analysis cut-0ff date = 23-Nov-2021||0.98|0.64|
91785515|NCT00281658|183451609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.66|||||The Pike estimator of the treatment hazard ratio based on the log rank test stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|||0.66|0.44|
91785516|NCT00281658|183451610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|1.54|3.47||||||||3.47|1.54|
91785517|NCT00281658|183451611|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.54|3.58||||||||3.58|1.54|
91785518|NCT00281658|183451616|OTHER||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.07|7.57||||||Participants with PIK3CA wild-type||7.57|1.07|
91600948|NCT04202679|183093682|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0194|TWO_SIDED|95.0|1.13|7.52||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||7.52|1.13|0.0194
91600949|NCT04202679|183093683|SUPERIORITY||LS mean difference|-23.16|||<|0.0001|TWO_SIDED|95.0|-33.81|-12.51||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-12.51|-33.81|<0.0001
91600950|NCT04202679|183093684|SUPERIORITY||LS mean difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.42|-4.36||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.36|-8.42|<0.0001
91600951|NCT04202679|183093685|SUPERIORITY||LS mean difference|-1.61||||0.0003|TWO_SIDED|95.0|-2.49|-0.73||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.73|-2.49|0.0003
91600952|NCT04202679|183093686|SUPERIORITY||LS mean difference|0.54||||0.1658|TWO_SIDED|95.0|-0.22|1.3||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||1.30|-0.22|0.1658
91600953|NCT04202679|183093694|SUPERIORITY||LS mean difference|-0.61||||0.037|TWO_SIDED|95.0|-1.18|-0.04||Threshold of significance was \<0.05.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|||-0.04|-1.18|0.0370
91600954|NCT02531646|183093708|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
91600955|NCT02531646|183093709|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
91785519|NCT00281658|183451617|OTHER||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.28|4.63||||||Participants with PTEN low||4.63|1.28|
91785520|NCT00281658|183451617|OTHER||Odds Ratio (OR)|2.21|||||TWO_SIDED|95.0|1.04|4.82||||||Participants without PTEN low||4.82|1.04|
91600956|NCT02531646|183093710|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
91600957|NCT02531646|183093711|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
91600958|NCT02531646|183093712|SUPERIORITY_OR_OTHER|||||||0.007||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.007
91600959|NCT02531646|183093714|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
91600960|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|18.24|||<|0.001|TWO_SIDED|90.0|14.97|21.67||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||21.67|14.97|<.001
91600961|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|62.86|||<|0.001|TWO_SIDED|90.0|58.21|67.74||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||67.74|58.21|<.001
91600962|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|1.11||||0.128|TWO_SIDED|90.0|-0.1|2.33||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||2.33|-0.10|0.128
91600963|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|88.24|||<|0.001|TWO_SIDED|90.0|85.77|90.76||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||90.76|85.77|<.001
91600964|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|44.62|||<|0.001|TWO_SIDED|90.0|34.51|55.23||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||55.23|34.51|<.001
91600965|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|-17.13|||<|0.001|TWO_SIDED|90.0|-21.21|-13.25||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-13.25|-21.21|<.001
91600966|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|70.0|||<|0.001|TWO_SIDED|90.0|58.46|82.2||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||82.20|58.46|<.001
91785521|NCT00281658|183451619|OTHER||Odds Ratio (OR)|3.15|||||TWO_SIDED|95.0|1.58|6.49||||||Participants with PTEN low||6.49|1.58|
91785522|NCT00281658|183451619|OTHER||Odds Ratio (OR)|2.49|||||TWO_SIDED|95.0|1.13|5.66||||||Participants without PTEN low||5.66|1.13|
91790498|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91785523|NCT01248104|183451624|SUPERIORITY_OR_OTHER_LEGACY|Continuous variables were compared by multivariate linear regression analysis to adjust for possible covariates of intraoperative fluids, age, bypass time, and procedure time. Tukey-Kramer test was then used to compare for specific differences between groups for each variable. Categorical data were compared using Fisher's exact test. All comparisons were made at a significance level of 0.05, and analysis was performed with Minitab version 17).||||||0.35||||||The primary outcome measure showed that there was no difference in PRBC transfusion frequency or amounts in the operating room or the in ICU up to POD 2|ANOVA|||A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.||||0.35
91522668|NCT04425902|182920447|OTHER||Ratio of geometric least square mean|0.95|||||TWO_SIDED|90.0|0.83|1.08|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.08|0.83|
91600967|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|-61.75|||<|0.001|TWO_SIDED|90.0|-68.76|-55.18||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-55.18|-68.76|<.001
91600968|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|25.38|||<|0.001|TWO_SIDED|90.0|15.37|35.48||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||35.48|15.37|<.001
91600969|NCT01582308|183093727|SUPERIORITY_OR_OTHER||Least squares mean difference|87.13|||<|0.001|TWO_SIDED|90.0|80.06|94.61||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||94.61|80.06|<.001
91600970|NCT02554929|183093798|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.002|TWO_SIDED|95.0|-0.91|0.74||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||0.74|-0.91|0.002
91600971|NCT02554929|183093798|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-0.95|1.48||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||1.48|-0.95|0.002
91600972|NCT02554929|183093801|SUPERIORITY||Mean Difference (Final Values)|1.89|STANDARD_ERROR_OF_MEAN|3.14||0.002|TWO_SIDED|95.0|-4.28|8.08||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||8.08|-4.28|0.002
91785524|NCT01410357|183451637|SUPERIORITY|||||||0.785||||||Bonferroni corrections were conducted to adjust for multiple comparisons.|Mixed Models Analysis|||||||.785
91785525|NCT01410357|183451638|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.016
91600973|NCT04024501|183093804|OTHER||Geometric Mean ratio|106.2|||||TWO_SIDED|90.0|91.73|122.96|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 2/Treatment 1||122.96|91.73|
91600974|NCT04024501|183093804|OTHER||Geometric mean ratio|50.02|||||TWO_SIDED|90.0|42.34|59.1|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 3/Treatment 1||59.10|42.34|
91600975|NCT04024501|183093804|OTHER||Geometric mean ratio|47.1|||||TWO_SIDED|90.0|39.85|55.68|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 2||55.68|39.85|
91600976|NCT04024501|183093804|OTHER||Geometric mean ratio|58.4|||||TWO_SIDED|90.0|49.49|68.92|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 4||68.92|49.49|
91600977|NCT04024501|183093804|OTHER||Geometric mean ratio|85.65|||||TWO_SIDED|90.0|73.78|99.43|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 1||99.43|73.78|
91785526|NCT01410357|183451639|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||<0.001
91785527|NCT01410357|183451640|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.003
91785528|NCT01410357|183451641|SUPERIORITY|||||||0.086|||||||Mixed Models Analysis|||||||.086
91600978|NCT04024501|183093804|OTHER||Geometric mean ratio|80.65|||||TWO_SIDED|90.0|69.48|93.62|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 2||93.62|69.48|
91600979|NCT04024501|183093804|OTHER||Geometric mean ratio|89.88|||||TWO_SIDED|90.0|77.61|104.09|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 1||104.09|77.61|
91785529|NCT01410357|183451642|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.872
91785530|NCT01410357|183451643|SUPERIORITY|||||||0.662|||||||Mixed Models Analysis|||||||.662
91785531|NCT01410357|183451644|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||||||.633
91785532|NCT01410357|183451645|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.175
91785533|NCT01410357|183451646|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.680
91785534|NCT01410357|183451647|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||.407
91785535|NCT01410357|183451648|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||.870
91600980|NCT04024501|183093804|OTHER||Geometric mean ratio|84.64|||||TWO_SIDED|90.0|72.94|98.2|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 2||98.20|72.94|
91600981|NCT04024501|183093804|OTHER||Geometric mean ratio|179.68|||||TWO_SIDED|90.0|151.57|212.99|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 3||212.99|151.57|
91600982|NCT04024501|183093804|OTHER||Geometric mean ratio|104.94|||||TWO_SIDED|90.0|90.18|122.11|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 4||122.11|90.18|
91600983|NCT04024501|183093805|OTHER||Geometric mean ratio|100.39|||||TWO_SIDED|90.0|84.94|118.65|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||118.65|84.94|
91600984|NCT04024501|183093805|OTHER||Geometric mean ratio|41.26|||||TWO_SIDED|90.0|34.74|49.0|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||49.00|34.74|
91600985|NCT04024501|183093805|OTHER||Geometric mean ratio|41.1|||||TWO_SIDED|90.0|34.61|48.81|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||48.81|34.61|
91785536|NCT01410357|183451649|SUPERIORITY|||||||0.707|||||||Mixed Models Analysis|||||||.707
91785537|NCT01410357|183451650|SUPERIORITY|||||||0.838|||||||Mixed Models Analysis|||||||.838
91600986|NCT04024501|183093805|OTHER||Geometric mean ratio|53.55|||||TWO_SIDED|90.0|45.09|63.59|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||63.59|45.09|
91600987|NCT04024501|183093805|OTHER||Geometric mean ratio|77.05|||||TWO_SIDED|90.0|65.19|91.06|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||91.06|65.19|
91785538|NCT01410357|183451651|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
91600988|NCT04024501|183093805|OTHER||Geometric mean ratio|76.75|||||TWO_SIDED|90.0|64.94|90.71|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.71|64.94|
91600989|NCT04024501|183093805|OTHER||Geometric mean ratio|84.23|||||TWO_SIDED|90.0|70.93|100.03|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||100.03|70.93|
91600990|NCT04024501|183093805|OTHER||Geometric mean ratio|83.9|||||TWO_SIDED|90.0|70.65|99.64|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||99.64|70.65|
91600991|NCT04024501|183093805|OTHER||Geometric mean ratio|204.16|||||TWO_SIDED|90.0|171.22|243.42|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||243.42|171.22|
91600992|NCT04024501|183093805|OTHER||Geometric mean ratio|109.32|||||TWO_SIDED|90.0|92.06|129.83|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||129.83|92.06|
91600993|NCT04024501|183093806|OTHER||Geometric mean ratio|124.99|||||TWO_SIDED|90.0|101.09|154.54|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||154.54|101.09|
91600994|NCT04024501|183093806|OTHER||Geometric mean ratio|33.77|||||TWO_SIDED|90.0|27.15|42.01|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||42.01|27.15|
91600995|NCT04024501|183093806|OTHER||Geometric mean ratio|27.02|||||TWO_SIDED|90.0|21.72|33.61|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||33.61|21.72|
91600996|NCT04024501|183093806|OTHER||Geometric mean ratio|36.84|||||TWO_SIDED|90.0|29.61|45.82|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||45.82|29.61|
91600997|NCT04024501|183093806|OTHER||Geometric mean ratio|91.69|||||TWO_SIDED|90.0|74.15|113.36|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||113.36|74.15|
91600998|NCT04024501|183093806|OTHER||Geometric mean ratio|73.36|||||TWO_SIDED|90.0|59.33|90.7|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.70|59.33|
91600999|NCT04024501|183093806|OTHER||Geometric mean ratio|67.62|||||TWO_SIDED|90.0|54.37|84.12|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||84.12|54.37|
91601000|NCT04024501|183093806|OTHER||Geometric mean ratio|54.11|||||TWO_SIDED|90.0|43.5|67.3|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||67.30|43.50|
91601001|NCT04024501|183093806|OTHER||Geometric mean ratio|200.23|||||TWO_SIDED|90.0|160.15|250.32|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||250.32|160.15|
91601002|NCT04024501|183093806|OTHER||Geometric mean ratio|73.76|||||TWO_SIDED|90.0|59.3|91.75|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||91.75|59.30|
91601003|NCT04187092|183093818|SUPERIORITY||||||<|0.05|||||||ANCOVA|||The 12-week changes in the KOOS scores, and the 12-week changes in the IKDC scores were analyzed by way of analysis of covariance (ANCOVA). Covariates: Age and sex of the subject, the subject's baseline outcome measure, the subject's baseline IKDC Total score, and the subject's standardized intake date (i.e., i.e., subject's intake date minus the intake date of the first enrolled subject) served as the ANCOVA concomitant adjustment variables||||<0.05
91601004|NCT04660643|183093820|SUPERIORITY||LS Mean difference|-21.4|||<|0.001|TWO_SIDED|95.0|-22.9|-20.0|||Mixed Models Analysis|||||-20.0|-22.9|<.001
91601005|NCT04660643|183093821|SUPERIORITY||LS Mean difference|-15.9|||<|0.001|TWO_SIDED|95.0|-17.0|-14.9|||Mixed Models Analysis|||||-14.9|-17.0|<.001
91785539|NCT01410357|183451652|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
91785540|NCT01410357|183451653|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||.510
91785541|NCT01410357|183451654|SUPERIORITY|||||||0.573|||||||Mixed Models Analysis|||||||.573
91785542|NCT01410357|183451655|SUPERIORITY|||||||0.758|||||||Mixed Models Analysis|||||||.758
91785543|NCT01410357|183451656|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
91785544|NCT01410357|183451657|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
91785545|NCT01410357|183451658|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91785546|NCT01410357|183451659|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||||||.878
91785547|NCT01410357|183451660|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
91785548|NCT01410357|183451661|SUPERIORITY|||||||0.227|||||||Mixed Models Analysis|||||||.227
91601006|NCT04660643|183093822|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
91601007|NCT04660643|183093823|SUPERIORITY||LS Mean difference|-12.9|||<|0.001|TWO_SIDED|95.0|-14.1|-11.7|||Mixed Models Analysis|||||-11.7|-14.1|<.001
91601008|NCT04660643|183093824|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
91790499|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.067||0.51|TWO_SIDED|95.0|-0.177|0.088||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.088|-0.177|0.510
91601009|NCT04660643|183093825|SUPERIORITY||LS Mean difference|-8.64|||<|0.001|TWO_SIDED|95.0|-10.14|-7.15|||Mixed Models Analysis|||||-7.15|-10.14|<.001
91601010|NCT04660643|183093826|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.38|-0.28|||Mixed Models Analysis|||||-0.28|-0.38|<.001
91601011|NCT04660643|183093827|SUPERIORITY||LS Mean difference|-31.4|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-37.7|-24.4|||Mixed Models Analysis|||||-24.4|-37.7|<.001
91601012|NCT04660643|183093828|SUPERIORITY||LS Mean difference|-5.54|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-7.76|-3.28|||Mixed Models Analysis|||Total Cholesterol||-3.28|-7.76|<.001
91601013|NCT04660643|183093828|SUPERIORITY||LS Mean difference|-6.57|STANDARD_ERROR_OF_MEAN|1.709|<|0.001|TWO_SIDED|95.0|-9.87|-3.15|||Mixed Models Analysis|||LDL Cholesterol||-3.15|-9.87|<.001
91601014|NCT04660643|183093828|SUPERIORITY||LS Mean difference|3.2|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.6|5.8|||Mixed Models Analysis|||HDL Cholesterol||5.8|0.6|0.014
91601015|NCT04660643|183093828|SUPERIORITY||LS Mean difference|-19.7|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-24.0|-15.1|||Mixed Models Analysis|||VLDL Cholesterol||-15.1|-24.0|<.001
91601016|NCT04660643|183093828|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-24.9|-16.0|||Mixed Models Analysis|||Triglycerides||-16|-24.9|<.001
91601017|NCT04660643|183093828|SUPERIORITY||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|3.79||0.008|TWO_SIDED|95.0|-17.9|-3.0|||Mixed Models Analysis|||FFA||-3.0|-17.9|0.008
91601018|NCT04660643|183093829|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-8.1|-4.6|||Mixed Models Analysis|||SBP||-4.6|-8.1|<.001
91601019|NCT04660643|183093829|SUPERIORITY||LS Mean difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.8|-2.4|||Mixed Models Analysis|||DBP||-2.4|-4.8|<.001
91601020|NCT04660643|183093830|SUPERIORITY||LS Mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.7|3.5|||ANCOVA|||||3.5|1.7|<.001
91601021|NCT04660643|183093831|SUPERIORITY||LS Mean difference|9.4|||<|0.001|TWO_SIDED|95.0|6.8|12.0|||ANCOVA|||||12.0|6.8|<0.001
91790500|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790501|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.069||0.601|TWO_SIDED|95.0|-0.1|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.100|0.601
91790502|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790503|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.157|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.157|0.783
91790504|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790505|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.068||0.646|TWO_SIDED|95.0|-0.165|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.103|-0.165|0.646
91790506|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790507|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.209|TWO_SIDED|95.0|-0.226|0.05||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.050|-0.226|0.209
91790508|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790509|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.091||0.454|TWO_SIDED|95.0|-0.246|0.11||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.110|-0.246|0.454
91790510|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790511|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.141|TWO_SIDED|95.0|-0.306|0.043||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.043|-0.306|0.141
91785549|NCT01589653|183451688|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently when the p-value for the one-sided test of H0: D \> 0.4% against HA: D ≤ 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|Treatment difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.54|0.08|||Regression, Linear|Analyses were adjusted for treatment, strata, country and baseline HbA1c||The null-hypothesis was tested against the alternative hypothesis of non-inferiority as given by: H0: D \> 0.4% against HA: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (subject-driven titration minus investigator-driven titration).||0.08|-0.54|<0.001
91785550|NCT01767142|183451731|OTHER||sucess proportion|83.9|||||TWO_SIDED|95.0|74.8|90.7||||||||90.7|74.8|
91785551|NCT00635219|183451738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.13||0.1321|TWO_SIDED|95.0|-3.92|0.51||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.51|-3.92|0.1321
91785552|NCT00635219|183451738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1847|TWO_SIDED|95.0|-3.73|0.72||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.72|-3.73|0.1847
91785553|NCT00635219|183451738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.12||0.2187|TWO_SIDED|95.0|-3.59|0.82||This dose was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.82|-3.59|0.2187
91785554|NCT00635219|183451738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.14||0.0741|TWO_SIDED|95.0|-4.27|0.2||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.20|-4.27|0.0741
91785555|NCT00635219|183451739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|1.13||0.112|TWO_SIDED|95.0|-4.01|0.42||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.42|-4.01|0.1120
91785556|NCT00635219|183451739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.1487|TWO_SIDED|95.0|-3.85|0.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.59|-3.85|0.1487
91785557|NCT00635219|183451739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.12||0.3246|TWO_SIDED|95.0|-3.31|1.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.10|-3.31|0.3246
91785558|NCT00635219|183451739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|1.13||0.0298|TWO_SIDED|95.0|-4.7|-0.24||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||-0.24|-4.70|0.0298
91785559|NCT00635219|183451740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.137|TWO_SIDED|95.0|0.9|2.23||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.23|0.90|0.1370
91785560|NCT00635219|183451740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0664|TWO_SIDED|95.0|0.97|2.43||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.43|0.97|0.0664
91601022|NCT04660643|183093832|SUPERIORITY||Odds Ratio (OR)|95.91|||<|0.001|TWO_SIDED|95.0|54.72|168.09|||Regression, Logistic|||||168.09|54.72|<0.001
91601023|NCT04660643|183093833|SUPERIORITY||Odds Ratio (OR)|47.27|||<|0.001|TWO_SIDED|95.0|18.32|121.99|||Regression, Logistic|||≥5% body weight reduction from baseline||121.99|18.32|<0.001
91601024|NCT04660643|183093833|SUPERIORITY||Odds Ratio (OR)|71.51|||<|0.001|TWO_SIDED|95.0|34.46|148.39|||Regression, Logistic|||≥10% body weight reduction from baseline||148.39|34.46|<0.001
91601025|NCT04660643|183093833|SUPERIORITY||Odds Ratio (OR)|79.99|||<|0.001|TWO_SIDED|95.0|42.06|152.14|||Regression, Logistic|||≥15% body weight reduction from baseline||152.14|42.06|<0.001
91601026|NCT04660643|183093833|SUPERIORITY||Odds Ratio (OR)|140.84|||<|0.001|TWO_SIDED|95.0|66.06|300.29|||Regression, Logistic|||≥20% body weight reduction from baseline||300.29|66.06|<0.001
91785561|NCT00635219|183451740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.2023|TWO_SIDED|95.0|0.85|2.12||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.12|0.85|0.2023
91601027|NCT04660643|183093834|SUPERIORITY||Hazard Ratio (HR)|0.013|||<|0.001|TWO_SIDED|95.0|0.004|0.046|||Log Rank||Unstratified hazard ratio from Cox proportional hazard model with Baseline Weight (kg), Analysis Country, Sex, IWRS MTD at Week 36, Weight at randomization (kg) as covariates.|||0.046|0.004|<.001
91601028|NCT04660643|183093835|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
91601029|NCT04660643|183093836|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
91601030|NCT04660643|183093837|SUPERIORITY||LS Mean difference|-16.4|||<|0.001|TWO_SIDED|95.0|-17.5|-15.4|||Mixed Models Analysis|||||-15.4|-17.5|<.001
91601031|NCT04660643|183093838|SUPERIORITY||LS Mean difference|-13.6|||<|0.001|TWO_SIDED|95.0|-15.1|-12.2|||Mixed Models Analysis|||||-12.2|-15.1|<.001
91601032|NCT04660643|183093839|SUPERIORITY||LS Mean difference|-8.92|||<|0.001|TWO_SIDED|95.0|-10.4|-7.43|||Mixed Models Analysis|||||-7.43|-10.40|<.001
91601033|NCT04660643|183093840|SUPERIORITY||LS Mean difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.39|-0.29|||Mixed Models Analysis|||||-0.29|-0.39|<.001
91785562|NCT00635219|183451740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0765|TWO_SIDED|95.0|0.96|2.4||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.40|0.96|0.0765
91785563|NCT00635219|183451741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1436|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1436
91785564|NCT00635219|183451741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2114|TWO_SIDED|95.0|-0.44|0.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.10|-0.44|0.2114
91785565|NCT00635219|183451741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1389|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1389
91785566|NCT00635219|183451741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1271|TWO_SIDED|95.0|-0.48|0.06||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.06|-0.48|0.1271
91785567|NCT00635219|183451742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4421|TWO_SIDED|95.0|-4.08|1.79||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.79|-4.08|0.4421
91785568|NCT00635219|183451742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4399|TWO_SIDED|95.0|-4.07|1.77||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.77|-4.07|0.4399
91601034|NCT04660643|183093841|SUPERIORITY||LS Mean difference|-34.6|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-40.6|-27.9|||Mixed Models Analysis|||||-27.9|-40.6|<.001
91601035|NCT04660643|183093842|SUPERIORITY||LS Mean difference|-7.02|STANDARD_ERROR_OF_MEAN|1.158|<|0.001|TWO_SIDED|95.0|-9.27|-4.72|||Mixed Models Analysis|||Total Cholesterol||-4.72|-9.27|<.001
91601036|NCT04660643|183093842|SUPERIORITY||LS Mean difference|-7.62|STANDARD_ERROR_OF_MEAN|1.707|<|0.001|TWO_SIDED|95.0|-10.91|-4.21|||Mixed Models Analysis|||LDL Cholesterol||-4.21|-10.91|<.001
91601037|NCT04660643|183093842|SUPERIORITY||LS Mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.418||0.064|TWO_SIDED|95.0|-0.14|5.43|||Mixed Models Analysis|||HDL Cholesterol||5.43|-0.14|0.064
91785569|NCT00635219|183451742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|1.54||0.8093|TWO_SIDED|95.0|-2.65|3.4||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||3.40|-2.65|0.8093
91785570|NCT00635219|183451742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.53||0.0897|TWO_SIDED|95.0|-5.61|0.41||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.41|-5.61|0.0897
91785571|NCT00635219|183451743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.98||0.6748|TWO_SIDED|95.0|-2.35|1.52||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.52|-2.35|0.6748
91785572|NCT00635219|183451743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.99||0.0871|TWO_SIDED|95.0|-3.64|0.25||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.25|-3.64|0.0871
91785573|NCT00635219|183451743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|0.99||0.3186|TWO_SIDED|95.0|-2.94|0.96||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.96|-2.94|0.3186
91522669|NCT04425902|182920450|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
91601038|NCT04660643|183093842|SUPERIORITY||LS Mean difference|-20.1|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-24.7|-15.3|||Mixed Models Analysis|||VLDL Cholesterol||-15.3|-24.7|<.001
91601039|NCT04660643|183093842|SUPERIORITY||LS Mean difference|-21.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-25.8|-16.4|||Mixed Models Analysis|||Triglycerides||-16.4|-25.8|<.001
91601040|NCT04660643|183093842|SUPERIORITY||LS Mean difference|-11.83|STANDARD_ERROR_OF_MEAN|3.793||0.004|TWO_SIDED|95.0|-18.98|-4.06|||Mixed Models Analysis|||FFA||-4.06|-18.98|0.004
91601041|NCT04660643|183093843|SUPERIORITY||LS Mean difference|-6.9|||<|0.001|TWO_SIDED|95.0|-8.7|-5.1|||Mixed Models Analysis|||SBP||-5.1|-8.7|<.001
91601042|NCT04660643|183093843|SUPERIORITY||LS Mean difference|-3.8|||<|0.001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|||DBP||-2.6|-5.1|<.001
91601043|NCT04660643|183093844|SUPERIORITY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.7|3.7|||ANCOVA|||||3.7|1.7|<.001
91601044|NCT04660643|183093845|SUPERIORITY||LS Mean difference|9.3|||<|0.001|TWO_SIDED|95.0|6.5|12.0|||ANCOVA|||||12.0|6.5|<.001
91601045|NCT01276821|183093869|NON_INFERIORITY_OR_EQUIVALENCE|Non - Inferiority Analysis|Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.3|<|0.05|TWO_SIDED|95.0|0.78|1.82|||t-test, 2 sided|||"Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.~Alternate Hypothesis:~Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis."||1.82|0.78|<0.05
91601046|NCT00066690|183093876|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.66|1.04|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.04|0.66|0.1
91601047|NCT00066690|183093876|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.86|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.86|0.53|
91601048|NCT00066690|183093877|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.09|TWO_SIDED|95.0|0.3|1.03|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.03|0.3|0.09
91601049|NCT00066690|183093877|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.49|0.83|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.83|0.49|
91601050|NCT00066690|183093878|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Log Rank||T was the reference group in the estimation of the hazard ratio.|||1.18|0.66|0.40
91601051|NCT00066690|183093878|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.96|||||T was the reference group in the estimation of hazard ratio.|||0.96|0.52|
91785574|NCT00635219|183451743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.01||0.0768|TWO_SIDED|95.0|-3.79|0.19||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.19|-3.79|0.0768
91785575|NCT00635219|183451744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6258|TWO_SIDED|95.0|0.7|1.81||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.81|0.70|0.6258
91785576|NCT00635219|183451744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7178|TWO_SIDED|95.0|0.68|1.76||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.76|0.68|0.7178
91785577|NCT00635219|183451744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8651|TWO_SIDED|95.0|0.59|1.55||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.55|0.59|0.8651
91785578|NCT00635219|183451744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8563|TWO_SIDED|95.0|0.65|1.69||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.69|0.65|0.8563
91785579|NCT00635219|183451745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.86||0.1925|TWO_SIDED|95.0|-2.82|0.57||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.57|-2.82|0.1925
91785580|NCT00635219|183451745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.87||0.2434|TWO_SIDED|95.0|-2.72|0.69||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.69|-2.72|0.2434
91785581|NCT00635219|183451745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86||0.7246|TWO_SIDED|95.0|-2.0|1.39||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.39|-2.00|0.7246
91601052|NCT00066690|183093879|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.48|0.92|||Log Rank||T was the reference group in the estimation of the hazard ratio|||0.92|0.48|0.01
91601053|NCT00066690|183093879|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.62|1.15|||||T was the reference group in the estimation of hazard ratio|||1.15|0.62|
91601054|NCT02939131|183093882|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not. The study was designed for at least 80% power to detect an effect size of 0.8 standard deviations (SD), which corresponded to a difference of four points. We assumed an intracluster correlation coefficient (ICC) between 0.02 and 0.16 and allowed for 10% non-evaluability. In a pre-planned interim analysis, we estimated the ICC based on the entry QIDS-SR to be 0.10.|Mean Difference (Final Values)|-3.86||||0.01|TWO_SIDED|95.0|-6.79|-0.94|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|||-0.94|-6.79|0.01
91650158|NCT00909727|183192676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|3.7||0.1092|TWO_SIDED|95.0|-1.4|13.5||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||13.5|-1.4|0.1092
91650159|NCT00909727|183192676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|3.3||0.1354|TWO_SIDED|95.0|-1.6|11.8||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||11.8|-1.6|0.1354
91785582|NCT00635219|183451745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.87||0.0981|TWO_SIDED|95.0|-3.16|0.27||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.27|-3.16|0.0981
91785583|NCT00635219|183451746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2285|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2285
91785584|NCT00635219|183451746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1794|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1794
91785585|NCT00635219|183451746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1741|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1741
91785586|NCT00635219|183451746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2247|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2247
91785587|NCT00635219|183451747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.86||0.7789|TWO_SIDED|95.0|-1.93|1.45||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.45|-1.93|0.7789
91785588|NCT00635219|183451747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.87||0.8121|TWO_SIDED|95.0|-1.91|1.5||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.50|-1.91|0.8121
91785589|NCT00635219|183451747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.87||0.8918|TWO_SIDED|95.0|-1.82|1.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.59|-1.82|0.8918
91785590|NCT00635219|183451747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.69|1.75||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.75|-1.69|0.9720
91785591|NCT04093024|183451755|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9858|TWO_SIDED|95.0|-0.8|0.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||0.8|-0.8|0.9858
91601055|NCT02939131|183093883|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|44.3|||<|0.001|TWO_SIDED|95.0|23.1|65.5|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|||65.5|23.1|<0.001
91601056|NCT02939131|183093884|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|30.9||||0.01|TWO_SIDED|95.0|8.9|52.9|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|||52.9|8.9|0.01
91785592|NCT04093024|183451756|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9769|TWO_SIDED|95.0|-1.7|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||1.6|-1.7|0.9769
91785593|NCT04093024|183451758|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.4||0.4442|TWO_SIDED|95.0|-1.8|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||4.0|-1.8|0.4442
91785594|NCT04093024|183451761|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.882|TWO_SIDED|95.0|-1.5|1.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.8|-1.5|0.8820
91785595|NCT04093024|183451762|OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.9652|TWO_SIDED|95.0|-3.2|3.3|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.3|-3.2|0.9652
91601057|NCT02939131|183093885|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|19.0||||0.86|TWO_SIDED|95.0|-223.0|262.0|||t-test, 2 sided||Group mean for ESC is subtracted from the group mean for COMB-R. The group means are the means of the site mean CD4 cell counts.|||262|-223|0.86
91601058|NCT02939131|183093886|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.17||||0.66|TWO_SIDED|95.0|-0.65|0.99|||t-test, 2 sided||We subtracted the group mean for the ESC group from the group mean of the COMB-R group. The group means are the means of the site mean log10 HIV RNA copies/mL.|||0.99|-0.65|0.66
91601059|NCT02939131|183093887|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|95.0|0.1|4.0|||t-test, 2 sided||A positive difference indicates COMB-R group had a site-level average of more days in last 30 with missed HIV medication doses.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 24.||4.0|0.1|0.04
91601060|NCT02939131|183093887|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.96|TWO_SIDED|95.0|-5.0|5.2|||t-test, 2 sided||A positive difference reflects greater number of days with missed HIV medication doses in last 30 days for COMB-R group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 48.||5.2|-5.0|0.96
91601061|NCT02939131|183093888|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.27|TWO_SIDED|95.0|-1.1|0.4|||t-test, 2 sided||A positive difference means the COMB-R group rated adherence to HIV medications better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 24.||0.4|-1.1|0.27
91601062|NCT02939131|183093888|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 48.||0.9|-0.4|0.44
91601063|NCT02939131|183093889|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.1|0.2|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 24.||0.2|-1.1|0.14
91785596|NCT04093024|183451763|OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1||0.4084|TWO_SIDED|95.0|-9.3|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||4.0|-9.3|0.4084
91785597|NCT04093024|183451764|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9928|TWO_SIDED|95.0|-1.6|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.6|-1.6|0.9928
91601064|NCT02939131|183093889|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.49|TWO_SIDED|95.0|-0.6|1.1|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 48.||1.1|-0.6|0.49
91601065|NCT02939131|183093890|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED|95.0|0.0|4.4|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group had more days with missed depression medications than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 24.||4.4|0.0|0.05
91601066|NCT02939131|183093890|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.53|TWO_SIDED|95.0|-12.5|7.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported more days with missed doses than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 48.||7.1|-12.5|0.53
91601067|NCT02939131|183093891|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.13|TWO_SIDED|95.0|-1.5|0.2|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 24.||0.2|-1.5|0.13
91601068|NCT02939131|183093891|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.53|TWO_SIDED|95.0|-1.1|2.0|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking their medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 48.||2.0|-1.1|0.53
91522670|NCT04425902|182920451|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
91785598|NCT04093024|183451765|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6366|TWO_SIDED|95.0|-2.3|3.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.6|-2.3|0.6366
91785599|NCT04093024|183451766|OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.3||0.8823|TWO_SIDED|95.0|-5.2|5.9|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||5.9|-5.2|0.8823
91785600|NCT04093024|183451767|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.2052|STANDARD_ERROR_OF_MEAN|2.2491||0.5962|TWO_SIDED|95.0|-3.3966|5.807|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.8070|-3.3966|0.5962
91785601|NCT04093024|183451768|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.7733|STANDARD_ERROR_OF_MEAN|3.1424||0.5776|TWO_SIDED|95.0|-4.7015|8.2481|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.2481|-4.7015|0.5776
91785602|NCT04093024|183451769|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-0.134|STANDARD_ERROR_OF_MEAN|4.316||0.9755|TWO_SIDED|95.0|-8.975|8.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.707|-8.975|0.9755
91785603|NCT04093024|183451770|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|3.453|STANDARD_ERROR_OF_MEAN|5.225||0.514|TWO_SIDED|95.0|-7.25|14.157|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||14.157|-7.250|0.5140
91785604|NCT04093024|183451771|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|3.358||0.7613|TWO_SIDED|95.0|-5.848|7.908|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||7.908|-5.848|0.7613
91785605|NCT04093024|183451772|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|5.049||0.9468|TWO_SIDED|95.0|-10.026|10.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||10.707|-10.026|0.9468
91785606|NCT04093024|183451773|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.33||0.0908|TWO_SIDED|95.0|-0.39|5.02|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.02|-0.39|0.0908
91785607|NCT04093024|183451774|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.28|STANDARD_ERROR_OF_MEAN|1.39||0.1222|TWO_SIDED|95.0|-0.69|5.25|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.25|-0.69|0.1222
91785608|NCT04093024|183451775|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|28.2||0.8012|TWO_SIDED|95.0|-50.7|65.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||65.0|-50.7|0.8012
91785609|NCT04093024|183451776|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|33.8||0.3401|TWO_SIDED|95.0|-103.1|37.2|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||37.2|-103.1|0.3401
91785610|NCT00435045|183451794|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used.||||||0.0002||95.0|||||ANOVA|||||||0.0002
91785611|NCT03052426|183451819|SUPERIORITY|||||||0.9327||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.1394, DF 2 for aches||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for aches/pains at the three month time frame||||0.9327
91601069|NCT02939131|183093892|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 24.||0.1|-1.3|0.07
91601070|NCT02939131|183093892|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.28|TWO_SIDED|95.0|-0.8|2.3|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence than those in the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 48.||2.3|-0.8|0.28
91601071|NCT02939131|183093893|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.44|TWO_SIDED|95.0|-0.6|0.3|||t-test, 2 sided|||||0.3|-0.6|0.44
91601072|NCT02939131|183093895|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||The average number of scheduled study visits through week 24 was computed for each site. The analysis was of these site-level averages. These values were compared between study groups||0.3|-0.4|0.67
91601073|NCT02939131|183093895|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||We computed the average number of scheduled study visits through week 48 for each site. We then averaged the site-level values and compared study groups.||0.5|-0.7|0.74
91601074|NCT02939131|183093896|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.14|TWO_SIDED|95.0|-4.74|0.76|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|We tested the null hypothesis that the treatment group means were equal vs. not.||0.76|-4.74|0.14
91601075|NCT02939131|183093897|SUPERIORITY||Mean Difference (Final Values)|25.3||||0.05|TWO_SIDED|95.0|0.5|50.0|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|We tested the null hypothesis that the treatment group means were equal vs. not.||50.0|0.5|0.05
91601076|NCT02939131|183093898|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.24|TWO_SIDED|95.0|-12.3|44.8|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|We tested the null hypothesis that the treatment group means were equal vs. not.||44.8|-12.3|0.24
91601077|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|6.79||||0.01|TWO_SIDED|95.0|2.3|11.28||This is the test of effect modification by sex at birth|t-test, 2 sided||A positive value indicates that the treatment difference (lower QIDS-SR score with COMB-R than with ESC) was greater for females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||11.28|2.30|0.01
91601078|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.23|TWO_SIDED|95.0|-7.05|1.93||This is the test of effect modification by age group|t-test, 2 sided||A negative value indicates the treatment difference is greater for younger compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||1.93|-7.05|0.23
91785612|NCT03052426|183451819|SUPERIORITY|||||||0.7523||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.5693, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the three month time frame||||0.7523
91601079|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.31|TWO_SIDED|95.0|-8.48|2.95||This is the test of the effect modification of viral suppression status|t-test, 2 sided||A negative value indicates a greater treatment difference among those with viral suppression at study entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||2.95|-8.48|0.31
91601080|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.72|TWO_SIDED|95.0|-4.29|5.95||This is the test of effect modification by QIDS-SR depression level at study entry.|t-test, 2 sided||A positive value indicates a greater treatment difference among those with moderate levels of depression compared to severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.95|-4.29|0.72
91785613|NCT03052426|183451819|SUPERIORITY|||||||0.9196||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.1676, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the three month time frame.||||0.9196
91785614|NCT03052426|183451820|SUPERIORITY|||||||0.6316||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.9190, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSquare Analysis were completed||||0.6316
91522671|NCT04425902|182920452|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.72|1.69|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.69|0.72|
91522672|NCT04425902|182920455|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|0.97|1.2|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.20|0.97|
91522673|NCT04425902|182920456|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|0.98|1.21|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.21|0.98|
91522674|NCT04425902|182920457|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.92|1.17|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.17|0.92|
91601081|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.91|TWO_SIDED|95.0|-5.91|5.31||This is the test of effect modification by mode of transmission|t-test, 2 sided||A negative value would indicate a greater treatment difference for those with perinatal HIV acquisition compared to behavioral acquisition.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.31|-5.91|0.91
91522675|NCT04425902|182920460|OTHER||Ratio of geometric least square mean|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.88|
91522676|NCT04425902|182920461|OTHER||Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.89|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.89|
91522677|NCT04425902|182920462|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.93|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.93|
91522678|NCT04425902|182920465|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.72|1.75|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.75|0.72|
91522679|NCT04425902|182920466|OTHER||Ratio of geometric least square mean|0.97|||||TWO_SIDED|90.0|0.54|1.73|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.73|0.54|
91522680|NCT04425902|182920467|OTHER||Ratio of geometric least square mean|1.14|||||TWO_SIDED|90.0|0.73|1.78|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.78|0.73|
91522681|NCT04425902|182920470|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.8|1.11|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.11|0.80|
91522682|NCT04425902|182920471|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.79|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.79|
91522683|NCT04425902|182920472|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.73|1.12|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.12|0.73|
91522684|NCT04425902|182920475|OTHER||Ratio of geometric least square mean|1.07|||||TWO_SIDED|90.0|0.94|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.94|
91522685|NCT04425902|182920476|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.92|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.92|
91522686|NCT04425902|182920477|OTHER||Ratio of geometric least square mean|1.25|||||TWO_SIDED|90.0|0.96|1.63|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.63|0.96|
91522687|NCT04425902|182920480|OTHER||Ratio of geometric least square mean|0.73|||||TWO_SIDED|90.0|0.52|1.03|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.03|0.52|
91522688|NCT04425902|182920481|OTHER||Ratio of geometric least square mean|0.61|||||TWO_SIDED|90.0|0.45|0.82|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||0.82|0.45|
91522689|NCT04425902|182920482|OTHER||Ratio of geometric least square mean|0.78|||||TWO_SIDED|90.0|0.54|1.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.14|0.54|
91522690|NCT04425902|182920588|OTHER||Ratio of geometric least square mean|0.92|||||TWO_SIDED|90.0|0.49|1.71|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.71|0.49|
91522691|NCT04425902|182920589|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.74|1.16|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.16|0.74|
91522692|NCT04425902|182920590|OTHER||Ratio of geometric least square mean|0.86|||||TWO_SIDED|90.0|0.43|1.72|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.72|0.43|
91522693|NCT04425902|182920593|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
91522694|NCT04425902|182920594|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
91522695|NCT04425902|182920595|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.73|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.73|
91522696|NCT04425902|182920598|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.93|1.3|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.30|0.93|
91650160|NCT00909727|183192677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.3|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-61.8|-46.8||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.8|-61.8|<0.0001
91650161|NCT00909727|183192677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.5|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-60.9|-46.0||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.0|-60.9|<0.0001
91650162|NCT00909727|183192678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0004|TWO_SIDED|95.0|0.9|2.9||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||At Week 24: Analysis for this variable was based on a Linear Mixed Effect (LME) model with dependent variable weight; treatment as a fixed effect; and intercept, visit, and treatment by visit interaction as random effects, with adjustment for baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||2.9|0.9|0.0004
91650163|NCT00909727|183192678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.7||0.0002|TWO_SIDED|95.0|1.3|4.2||P-value is for the treatment effect at Week 48 (obtained as a linear contrast of treatment at Day 336). There was no adjustment for multiple comparisons.|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a Linear Mixed Effect (LME) model with random intercept and random slope, treatment as a fixed effect, and visit (days on study) and treatment by visit interaction as random effects, with adjustment for categorical baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.2|1.3|0.0002
91650164|NCT02491788|183192723|SUPERIORITY||Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91650165|NCT00672620|183192724|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.036||0.577|TWO_SIDED|95.0|-2.61|1.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||All statistical tests were 2-sided with 95% confidence intervals (CIs), and with P-values evaluated at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||1.46|-2.61|0.577
91650166|NCT00672620|183192724|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.038||0.138|TWO_SIDED|95.0|-3.58|0.5|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||0.50|-3.58|0.138
91650167|NCT00672620|183192724|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|1.047||0.005|TWO_SIDED|95.0|-5.02|-0.91|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||-0.91|-5.02|0.005
91785615|NCT03052426|183451820|SUPERIORITY|||||||0.2595||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 2.6983, DF||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the six month time frame.||||0.2595
91785616|NCT03052426|183451820|SUPERIORITY|||||||0.4495||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 1.5991, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the six month time frame||||0.4495
91650168|NCT02965820|183192741|SUPERIORITY||||||=|0.003|||||||Mixed Models Analysis|||||||=0.0030
91650169|NCT03051256|183192757|SUPERIORITY||||||<|0.0122|||||||Mixed Models Analysis|||||||<0.0122
91650170|NCT03051256|183192757|SUPERIORITY||||||<|0.0308|||||||Mixed Models Analysis|||||||<0.0308
91650171|NCT03051256|183192758|SUPERIORITY||||||<|0.0103|||||||Mixed Models Analysis|||||||<0.0103
91650172|NCT03051256|183192758|SUPERIORITY||||||<|0.0039|||||||Mixed Models Analysis|||||||<0.0039
91785617|NCT03052426|183451821|SUPERIORITY||||||<|0.0001||||||Aches (F-test G-G Epsilon (1.26, 15.18) = 34.70, p \< 0.0001)|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||<0.0001
91785618|NCT03052426|183451821|SUPERIORITY||||||=|0.0006||||||Uncomfortable (F-test G-G Epsilon (1.43, 17.15) = 14.39, p = 0.0006), from time 1 to times 2 and 3|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||=0.0006
91650173|NCT03051256|183192759|SUPERIORITY|||||||0.1237|||||||Mixed Models Analysis|||||||0.1237
91650174|NCT03051256|183192759|SUPERIORITY|||||||0.1017|||||||Mixed Models Analysis|||||||0.1017
91650175|NCT03051256|183192760|SUPERIORITY||||||<|0.0066|||||||Mixed Models Analysis|||||||<0.0066
91650176|NCT03051256|183192760|SUPERIORITY||||||<|0.0014|||||||Mixed Models Analysis|||||||<0.0014
91650177|NCT03051256|183192761|SUPERIORITY||||||<|0.0245|||||||Mixed Models Analysis|||||||<0.0245
91650178|NCT03051256|183192761|SUPERIORITY||||||<|0.0253|||||||Mixed Models Analysis|||||||<0.0253
91650179|NCT03051256|183192762|SUPERIORITY||||||<|0.0454|||||||Mixed Models Analysis|||||||<0.0454
91650180|NCT03051256|183192762|SUPERIORITY||||||<|0.0043|||||||Mixed Models Analysis|||||||<0.0043
91650181|NCT03051256|183192763|SUPERIORITY|||||||0.0177|||||||Mixed Models Analysis|||||||0.0177
91650182|NCT03051256|183192763|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||||||0.0072
91613679|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0002|TWO_SIDED|95.0|1.36|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are an option for nulliparous young women||2.71|1.36|0.0002
91522697|NCT04425902|182920599|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.83|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.83|
91709437|NCT04633291|183311482|SUPERIORITY||Odds Ratio (OR)|1.76||||0.381|TWO_SIDED|95.0|0.47|6.6||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.|Null hypothesis: No difference between the devices.||6.60|0.47|0.381
91601082|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.57|TWO_SIDED|95.0|-3.91|6.57||This is the test of effect modification by HIV CDC stage level|t-test, 2 sided||A positive value would indicate a greater treatment effect for those with less than HIV CDC Stage 3 compared to those with CDC Stage 3 HIV illness.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||6.57|-3.91|0.57
91601083|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|5.93||||0.1|TWO_SIDED|95.0|-1.73|13.59||This is the test of effect modification of CD4 Stage 3 at entry.|t-test, 2 sided||A positive value indicates a greater treatment effect among those with less than Stage 3 CD4 count at entry compared to those with Stage 3 CD4 count.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups..||13.59|-1.73|0.10
91601084|NCT02939131|183093899|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.58|TWO_SIDED|95.0|-7.74|4.6||This is the test of effect modification by Nadir Stage 3 level at study entry.|t-test, 2 sided||A negative value indicates a greater treatment effect among those with Stage 3 Nadir CD4 compare to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||4.60|-7.74|0.58
91650183|NCT03051256|183192764|SUPERIORITY|||||||0.0895|||||||Mixed Models Analysis|||||||0.0895
91650184|NCT03051256|183192764|SUPERIORITY|||||||0.0109|||||||Mixed Models Analysis|||||||0.0109
91650185|NCT01578707|183192778|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
91650186|NCT01578707|183192779|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
91650187|NCT01578707|183192780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1653|||||||Log Rank|||||||0.1653
91650188|NCT02063698|183192784|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2: BPI Worst Pain Past 24 Hours||||1.0
91650189|NCT02063698|183192784|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Day 3: BPI Worst Pain Past 24 Hours||||0.45
91650190|NCT02063698|183192784|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Day 4: BPI Worst Pain Past 24 Hours||||0.38
91650191|NCT02063698|183192784|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Day 5: BPI Worst Pain Past 24 Hours||||0.12
91650192|NCT02063698|183192784|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Day 6: BPI Worst Pain Past 24 Hours||||0.70
91650193|NCT02063698|183192784|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 7: BPI Worst Pain Past 24 Hours||||1.0
91650194|NCT02063698|183192784|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Day 8: BPI Worst Pain Past 24 Hours||||0.44
91650195|NCT02063698|183192785|SUPERIORITY|||||||0.44|||||||Equal variance t-test|||||||0.44
91650196|NCT02063698|183192786|SUPERIORITY|||||||0.13|||||||Equal variance t-test|||||||0.13
91650197|NCT02063698|183192788|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
91650198|NCT02063698|183192789|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91650199|NCT02063698|183192790|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
91650200|NCT02063698|183192791|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91650201|NCT02063698|183192792|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
91650202|NCT00449930|183192794|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus metformin) to be less than 0.4%.|Mean Difference (Net)|0.14|STANDARD_DEVIATION|0.57||||95.0|0.06|0.21|||||Based on an analysis of covariance (ANCOVA) model with terms for treatment group and baseline value.|||0.21|0.06|
91650203|NCT00449930|183192795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.3|||<|0.001||95.0|-10.6|-4.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with diarrhea.~Wilson Score method was used for the 95% Confidence Interval (CI)."|||-4.2|-10.6|<0.001
91650204|NCT00449930|183192796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.032||95.0|-3.9|-0.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with nausea.~Wilson Score method was used for the 95% CI."|||-0.2|-3.9|0.032
91650205|NCT00449930|183192797|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.7||||0.103||95.0|-4.0|0.3|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with abdominal pain.~Wilson Score method was used for the 95% CI."|||0.3|-4.0|0.103
91650206|NCT00449930|183192798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0||||||95.0|-2.4|0.2|||||"Difference (sitagliptin minus metformin) in the percentage of patients with vomiting.~Wilson Score method was used for the 95% CI."|||0.2|-2.4|
91601085|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|-67.81||||0.01|TWO_SIDED|95.0|-116.53|-19.1||This is the test of effect modification by sex at birth.|t-test, 2 sided||A negative value indicates a greater treatment response (higher percent with response in COMB-R than in ESC group) among females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||-19.10|-116.53|0.01
91601086|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|43.08||||0.09|TWO_SIDED|95.0|-8.23|94.38||This is the test of effect modification by age group.|t-test, 2 sided||A positive value reflects a greater treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.38|-8.23|0.09
91601087|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.93|TWO_SIDED|95.0|-51.13|55.49||This is the test of effect modification by viral suppression status.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with suppressed viral status at entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||55.49|-51.13|0.93
91601088|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.87|TWO_SIDED|95.0|-42.28|49.0||This is the test of effect modification by entry QIDS-SR depression level.|t-test, 2 sided||A positive value would indicate a greater treatment response for those with severe depressive symptoms at study entry compared to those with moderate depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||49.00|-42.28|0.87
91601089|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|41.65||||0.17|TWO_SIDED|95.0|-21.91|105.2||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would indicate a larger treatment response for those with perinatal transmission compared to behavioral.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||105.20|-21.91|0.17
91601090|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|49.4||||0.17|TWO_SIDED|95.0|-26.02|124.83||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value reflects a greater treatment response for those with HIV CDC Stage 3 classification compared to those with CDC classification less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||124.83|-26.02|0.17
91785619|NCT03052426|183451821|SUPERIORITY||||||<|0.0001||||||Interference (F-test G-G Epsilon (1.55, 18.66) = 34.09, p \< 0.0001), from time 1 to times 2 and 3.|MANOVA|||We used repeated measures MANOVAs with pairwise comparisons to examine the decrease of the variables over time. Significant differences for within subjects by time were found||||<0.0001
91785620|NCT00865280|183451853|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-2.0|||||TWO_SIDED|95.0|-12.4|8.5|||||The 95% confidence interval (CI) was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.5|-12.4|
91785621|NCT00865280|183451854|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-3.6|||||TWO_SIDED|95.0|-15.5|8.3|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.3|-15.5|
91785622|NCT00865280|183451855|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
91785623|NCT00865280|183451856|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
91785624|NCT00865280|183451857|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
91522698|NCT04425902|182920600|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.88|1.44|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.44|0.88|
91601091|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|11.69||||0.71|TWO_SIDED|95.0|-70.76|94.15||This is the test of effect modification by CD4 Stage at study entry.|t-test, 2 sided||A positive value would reflect greater treatment response for those with CD4 Stage 3 compared to those with less than Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.15|-70.76|0.71
91601092|NCT02939131|183093900|SUPERIORITY||Mean Difference (Final Values)|52.48||||0.02|TWO_SIDED|95.0|10.46|94.5||This is the test of effect modification by CD4 Nadir stage at study entry.|t-test, 2 sided||A positive value reflects a larger treatment response among those with Stage 3 Nadir CD4 compared to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.50|10.46|0.02
91601093|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|-45.06||||0.09|TWO_SIDED|95.0|-97.84|7.72||This is the test of effect modification by sex at birth|t-test, 2 sided||A negative value indicates a greater treatment effect (higher percent with remission for COMB-R than for ESC) among females.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||7.72|-97.84|0.09
91601094|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.95|TWO_SIDED|95.0|-43.38|46.2||This is the test of effect modification by age group.|t-test, 2 sided||A positive value would reflect a larger treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||46.20|-43.38|0.95
91601095|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|5.59||||0.79|TWO_SIDED|95.0|-40.47|51.65||This is the test of effect modification by viral suppression status.|Wilcoxon (Mann-Whitney)||A positive value would reflect a greater treatment effect among those with suppressed viral load compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.65|-40.47|0.79
91650207|NCT00575328|183192806|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in ASEX score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|3.3||0.62|TWO_SIDED|95.0|-8.7|12.3||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in ASEX score) between treatment arms. No formal power analysis was carried out, given the small study sample.|The analysis is not truly informative, since the analyzable sample (n=6) was too small. Results should be viewed with caution.|12.3|-8.7|0.62
91601096|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|-15.97||||0.42|TWO_SIDED|95.0|-58.88|26.94||This is the test of effect modification by QIDS-SR level at entry.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with moderate depression symptomatology at entry compared to those with severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||26.94|-58.88|0.42
91601097|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|9.99||||0.68|TWO_SIDED|95.0|-41.24|61.22||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would reflect a greater treatment effect among those with perinatal transmission compared to behavioral transmission.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||61.22|-41.24|0.68
91601098|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|-14.21||||0.57|TWO_SIDED|95.0|-70.62|42.2||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with HIV CDC Stage 3 classification compared to those with less than Stage 3 classification.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||42.20|-70.62|0.57
91601099|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|-44.97||||0.26|TWO_SIDED|95.0|-141.12|51.17||This is the test of effect modification by CD4 Stage.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with less than Stage 3 CD4 levels compared to those with Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.17|-141.12|0.26
91601100|NCT02939131|183093901|SUPERIORITY||Mean Difference (Final Values)|9.53||||0.72|TWO_SIDED|95.0|-52.97|72.02||This is the test of effect modification by CD4 nadir stage.|t-test, 2 sided||A positive value would reflect a greater treatment effect by those with Stage 3 CD4 Nadir compared to those with less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||72.02|-52.97|0.72
91601101|NCT02939131|183093902|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.26|TWO_SIDED|95.0|-8.4|28.1|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||28.1|-8.4|0.26
91601102|NCT02939131|183093902|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.66|TWO_SIDED|95.0|-37.1|24.6|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||24.6|-37.1|0.66
91601103|NCT02939131|183093903|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.71|TWO_SIDED|95.0|-22.3|31.7|||t-test, 2 sided||A positive value indicates higher site-level percentages in the COMB-R group.|The percent of participants with regular frequency alcohol use at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||31.7|-22.3|0.71
91785625|NCT00865280|183451858|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
91601104|NCT02939131|183093903|SUPERIORITY||Mean Difference (Final Values)|26.7||||0.1|TWO_SIDED|95.0|-6.3|59.6|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group.|The percent of participants at each site with regular alcohol use at week 48 was computed. These site-level percents were compared across treatments||59.6|-6.3|0.10
91601105|NCT02939131|183093904|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.09|TWO_SIDED|95.0|-2.6|0.2|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The average number of drinks per day reported at week 24 was computed for each site and these site-level averages were compared across treatments.||0.2|-2.6|0.09
91785626|NCT00329797|183451860|SUPERIORITY|||||||0.95|||||||Log Rank|||The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.||||0.95
91601106|NCT02939131|183093904|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|95.0|-0.8|1.0|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The site-level average numbers of drinks per day reported at week 48 were computed and these site-level averages were compared across treatment groups.||1.0|-0.8|0.79
91601107|NCT02939131|183093905|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-0.9|0.8|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group anc vice versa|The site-level average number of days with binge drinking at week 24 were computed and these site-level averages were compared across treatments.||0.8|-0.9|0.87
91601108|NCT02939131|183093905|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided||A positive difference would indicate site level averages were higher in the COMB-R group and vice versa|The site-level average number of days with binge drinking reported at week 48 were computed and the site-level averages were compared across treatment groups.||0.8|-0.8|0.99
91601109|NCT02939131|183093906|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.77|TWO_SIDED|95.0|-19.7|26.0|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with tobacco use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||26.0|-19.7|0.77
91601110|NCT02939131|183093906|SUPERIORITY||Mean Difference (Final Values)|14.7||||0.2|TWO_SIDED|95.0|-8.9|38.4|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group.|The percent of participants with tobacco use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||38.4|-8.9|0.20
91601111|NCT02939131|183093907|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.09|TWO_SIDED|95.0|-2.8|33.3|||t-test, 2 sided||A positive difference would indicate the site level percentages were higher in the COMB-R group.|This is the analysis of regular use of tobacco at week 24. The percent of participants at each site with regular use was computed. These site-level percentages were compared across treatment groups.||33.3|-2.8|0.09
91601112|NCT02939131|183093907|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.21|TWO_SIDED|95.0|-14.0|55.3|||t-test, 2 sided||A positive difference indicates site-level percentages were higher in the COMB-R group.|This is the analysis of regular frequency use of tobacco at week 48. Site level percentages of the numbers of participants with regular tobacco use were computed and compared across treatment groups.||55.3|-14.0|0.21
91601113|NCT02939131|183093908|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.41|TWO_SIDED|95.0|-12.4|28.3|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||28.3|-12.4|0.41
91601114|NCT02939131|183093908|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.26|TWO_SIDED|95.0|-10.9|36.8|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||36.8|-10.9|0.26
91601115|NCT02939131|183093908|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.69|TWO_SIDED|95.0|-20.2|29.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||29.5|-20.2|0.69
91601116|NCT02939131|183093908|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.96|TWO_SIDED|95.0|-24.8|23.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||23.5|-24.8|0.96
91601117|NCT02939131|183093909|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.53|TWO_SIDED|95.0|-23.9|44.1|||t-test, 2 sided||A positive difference indicates a higher site-level percentage of participants reporting regular use fof marijuana in the COMB-R group compared to the ESC group.|This is the analysis for regular use of marijuana (cannabis) at week 24. The percent of participants at each site reporting regular use (of those reporting any use) was computed. These site-level percentages were averaged and compared across treatments.||44.1|-23.9|0.53
91601118|NCT02939131|183093909|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-35.1|34.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular use of marijuana (cannabis) in the COMB-R group compared to the ESC group.|This is the analysis of regular use of marijuana (cannabis) at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||34.9|-35.1|1.0
91709438|NCT04633291|183311483|SUPERIORITY||Odds Ratio (OR)|7.8||||0.541|TWO_SIDED|95.0|-18.4|34.0||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|"OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.~Of note: Log transformed estimates."|Null hypothesis: No difference between the devices.||34.00|-18.40|0.541
91601119|NCT02939131|183093909|SUPERIORITY||Mean Difference (Final Values)|24.7||||0.18|TWO_SIDED|95.0|-16.2|65.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 24. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||65.5|-16.2|0.18
91601120|NCT02939131|183093909|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.34|TWO_SIDED|95.0|-59.5|22.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||22.9|-59.5|0.34
91601121|NCT02939131|183093910|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.29|TWO_SIDED|95.0|-12.9|39.6|||t-test, 2 sided||A positive value would indicate higher site-level percents in the COMB-R group.|This is the analysis for week 24. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||39.6|-12.9|0.29
91601122|NCT02939131|183093910|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.7|TWO_SIDED|95.0|-17.0|24.5|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group|This is the analysis for week 48. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||24.5|-17.0|0.70
91785627|NCT00329797|183451861|SUPERIORITY||||||<|0.0001||||||significance level = 0.05|t-test, 2 sided|||Lumbar||||<0.0001
91601123|NCT02939131|183093911|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.71|TWO_SIDED|95.0|-13.7|19.4|||t-test, 2 sided||A positive difference indicates the site-level averages were higher for the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.4|-13.7|0.71
91601124|NCT02939131|183093911|SUPERIORITY||Mean Difference (Final Values)|-4.7||||0.44|TWO_SIDED|95.0|-17.5|8.1|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||8.1|-17.5|0.44
91601125|NCT02939131|183093912|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.23|TWO_SIDED|95.0|-5.3|19.8|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.8|-5.3|0.23
91601126|NCT02939131|183093912|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.73|TWO_SIDED|95.0|-17.5|12.7|||t-test, 2 sided||A positive difference would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||12.7|-17.5|0.73
91601127|NCT02939131|183093913|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.24|TWO_SIDED|95.0|-0.4|1.5|||t-test, 2 sided||A positive value would indicate site-level averages were higher in COMB-R group.|This is the analysis for week 24. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.5|-0.4|0.24
91601128|NCT02939131|183093913|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.22|TWO_SIDED|95.0|-0.3|1.0|||t-test, 2 sided||A positive difference indicates site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.0|-0.3|0.22
91601129|NCT02939131|183093914|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.57|TWO_SIDED|95.0|-40.4|23.9|||t-test, 2 sided||A positive value would indicate higher site-level percents of low frequency condom use in COMB-R treatment group and vice versa.|This is the analysis for week 24 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||23.9|-40.4|0.57
91601130|NCT02939131|183093914|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.15|TWO_SIDED|95.0|-53.1|9.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|This is the analysis for week 48 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||9.5|-53.1|0.15
91601131|NCT02939131|183093915|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.65|TWO_SIDED|95.0|-40.9|27.2|||t-test, 2 sided||A positive difference would indicate site level percents were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 24, then averaged the site-level percentages by treatment group and compared these group average percents.||27.2|-40.9|0.65
91601132|NCT02939131|183093915|SUPERIORITY||Mean Difference (Final Values)|-37.8||||0.02|TWO_SIDED|95.0|-69.7|-5.8|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 48, then averaged the site-level percentages by treatment group and compared these group average percents.||-5.8|-69.7|0.02
91601133|NCT02939131|183093916|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.33|TWO_SIDED|95.0|-3.0|8.1|||t-test, 2 sided||A positive difference indicates COMB-R participants attended more sessions than ESC|We averaged the number of counseling sessions for each site and compared these site-level averages.||8.1|-3.0|0.33
91601134|NCT02939131|183093921|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.06|TWO_SIDED|95.0|-0.9|38.2|||t-test, 2 sided||A positive difference indicates more participants in the COMB-R group were taking medications, based on site-level percentages.|This is the analysis for the percent of participants on any psychiatric medication at week 24. Site-level percentages were compared across treatments.||38.2|-0.9|0.06
91785628|NCT00329797|183451861|SUPERIORITY|||||||0.47||||||significance level = 0.05|t-test, 2 sided|||Hip - right||||0.47
91785629|NCT00329797|183451861|SUPERIORITY|||||||0.0002||||||significance level = 0.05|t-test, 2 sided|||Hip - left||||0.0002
91785630|NCT00329797|183451861|SUPERIORITY|||||||0.076||||||significance level = 0.05|t-test, 2 sided|||Femoral - right||||0.076
91785631|NCT00329797|183451861|SUPERIORITY|||||||0.0007||||||significance level = 0.05|t-test, 2 sided|||Femoral - left||||0.0007
91785632|NCT00329797|183451862|SUPERIORITY|||||||0.33||||||significance level = 0.01|t-test, 2 sided|||Physical subscale||||0.33
91601135|NCT02939131|183093921|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.06|TWO_SIDED|95.0|-0.7|35.5|||t-test, 2 sided||A positive difference means the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on antidepressant medications. Site-level percentages were compared across treatments.||35.5|-0.7|0.06
91601136|NCT02939131|183093921|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.02|TWO_SIDED|95.0|4.2|40.6|||t-test, 2 sided||A positive difference indicates the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on SSRI antidepressant medications. Site-level percentages were compared across treatments.||40.6|4.2|0.02
91601137|NCT02939131|183093921|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.54|TWO_SIDED|95.0|-17.3|9.6|||t-test, 2 sided||A positive difference would indicate site-level percentages of those on medication were higher in the COMB-R group.|This is the analysis of the percent of participants on non-SSRI antidepressant medications. Site-level percentages were compared across treatments.||9.6|-17.3|0.54
91601138|NCT02939131|183093921|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.6|TWO_SIDED|95.0|-25.4|15.4|||t-test, 2 sided||A positive value would indicate the site-level percentages of those on medications were higher in the COMB-R group.|This is the analysis of the percent of participants on non-antidepressant psychiatric medications. Site-level percentages were compared across treatments.||15.4|-25.4|0.60
91601139|NCT02939131|183093922|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.77|TWO_SIDED|95.0|-32.5|24.8|||t-test, 2 sided||A positive difference would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on any psychiatric medication across treatment groups.||24.8|-32.5|0.77
91601140|NCT02939131|183093922|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.91|TWO_SIDED|95.0|-37.3|33.5|||t-test, 2 sided||A positive difference would indicate more study time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on single SSRI psychiatric medication across treatment groups.||33.5|-37.3|0.91
91601141|NCT02939131|183093922|SUPERIORITY||Mean Difference (Final Values)|-16.7||||0.4|TWO_SIDED|95.0|-60.2|26.9|||t-test, 2 sided||A positive value would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on SSRI+other psychiatric medication across treatment groups.||26.9|-60.2|0.40
91601142|NCT02939131|183093922|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.52|TWO_SIDED|95.0|-67.0|40.1|||t-test, 2 sided||A positive difference would indicate more time on medication in COMB-R group.|This is the analysis comparing site-level mean percents of study time on a single non-SSRI psychiatric medication across treatment groups.||40.1|-67.0|0.52
91601143|NCT02939131|183093922|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.96|TWO_SIDED|95.0|-778.0|785.7|||t-test, 2 sided|Because of sparseness, the confidence intervals for this site-level analysis are very large.|A positive difference indicates more time on medication in the COMB-R group. There was data from only one site in the ESC group and 2 sites in the COMB-R group. The confidence interval for the difference is quite large and the test is unreliable.|This is the analysis comparing site-level mean percents of study time on non-SSRI+other psychiatric medication across treatment groups. This analysis is unstable because of sparseness.||785.7|-778.0|0.96
91601144|NCT02939131|183093922|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.74|TWO_SIDED|95.0|-31.4|23.0|||t-test, 2 sided||A positive difference would reflect more time on medications in the COMB-R group|This is the analysis comparing site-level mean percents of study time on antidepressant medication across treatment groups.||23.0|-31.4|0.74
91601145|NCT02939131|183093923|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.29|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||A positive difference would indicate the site level average interim counseling sessions was higher in the COMB-R group.|We compared the site-level average number of interim counseling sessions between treatment groups.||8.2|-2.8|0.29
91601146|NCT02939131|183093925|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.03|TWO_SIDED|95.0|0.02|0.38|||t-test, 2 sided||A positive difference indicates higher site-level averages in the COMB-R group.|The average score for all participants at each site was computed. These site-level averages were compared across treatment groups.||0.38|0.02|0.03
91785633|NCT00329797|183451862|SUPERIORITY|||||||0.82||||||significance level = 0.01|t-test, 2 sided|||Social subscale||||0.82
91785634|NCT00329797|183451862|SUPERIORITY|||||||0.51||||||significance level = 0.01|t-test, 2 sided|||Emotional subscale||||0.51
91785635|NCT00329797|183451862|SUPERIORITY|||||||0.25||||||significance level = 0.01|t-test, 2 sided|||Functional subscale||||0.25
91785636|NCT00329797|183451862|SUPERIORITY|||||||0.63||||||significance level = 0.01|t-test, 2 sided|||Total||||0.63
91785637|NCT01901250|183451869|SUPERIORITY_OR_OTHER|||||||0.25|||||||Permutation test|Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.||||||0.25
91785638|NCT01980485|183451890|NON_INFERIORITY_OR_EQUIVALENCE|This study had 87% power to detect a 40% increase in 28-dayabstinence rates (i.e., from 50% to 70%) based on a two-tailed chi-squared test and alpha = 0.05. We selected this effect size as being at the lower end of the effect size continuum that would be clinically meaningful at 28 days and have the potential to still be meaningful in the longer term even with similar relapse rates in both groups over subsequent months.||||||0.65|||||||Chi-squared|||||||.65
91785639|NCT02633020|183451893|SUPERIORITY||LS Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|14.7||0.7451|TWO_SIDED|90.0|-30.26|20.56|||ANCOVA|Analysis of covariance (ANCOVA) with baseline % aberrant IELs vs total IELs as a covariate and treatment group as a fixed effect.||||20.56|-30.26|0.7451
91785640|NCT02633020|183451894|SUPERIORITY||LS Mean Difference|-38.22|STANDARD_ERROR_OF_MEAN|27.48||0.1803|TWO_SIDED|95.0|-95.73|19.29|||ANCOVA|ANCOVA model with baseline % aberrant IELs vs intestinal epithelial cells as a covariate and treatment group as a fixed effect.||||19.29|-95.73|0.1803
91785641|NCT02633020|183451895|SUPERIORITY||LS Mean Difference|10.67|STANDARD_ERROR_OF_MEAN|24.0||0.6607|TWO_SIDED|95.0|-38.97|60.31|||ANCOVA|ANCOVA model with baseline VH:CD ratio as a covariate and treatment group as a fixed effect.||||60.31|-38.97|0.6607
91785642|NCT02633020|183451896|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9204|TWO_SIDED|95.0|0.2|6.01|||Regression, Logistic|||||6.01|0.20|0.9204
91785643|NCT02633020|183451897|SUPERIORITY||LS Mean Difference|-12.73|STANDARD_ERROR_OF_MEAN|31.34||0.6885|TWO_SIDED|95.0|-77.57|52.12|||ANCOVA|ANCOVA) model with baseline total IEL counts as a covariate and treatment group as a fixed effect.||||52.12|-77.57|0.6885
91601147|NCT02939131|183093926|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.69|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided||A positive difference would indicate the site-level averages were higher in the COMB-R group compared to the ESC group and vice versa|The average of scores for all participants' clinicians at each site was computed and these site-level averages were compared across treatments.||0.29|-0.43|0.69
91601148|NCT02939131|183093927|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.004|TWO_SIDED|95.0|0.26|1.03|||t-test, 2 sided||A positive difference would indicate site-level averages were higher for the COMB-R group than the ESC group and vice versa.|The average scores for all participants' prescribing clinicians at each site were computed and these site-level averages were compared across treatment groups.||1.03|0.26|0.004
91601149|NCT02939131|183093928|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.16||||0.98|TWO_SIDED|95.0|-14.04|14.36|||t-test, 2 sided||We subtract group mean for ESC from group mean for COMB-R. The group means are the means of the site-level percentages of participants with events.|This is the analysis of new Grade 3+ signs/symptoms through week 24. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.36|-14.04|0.98
91601150|NCT02939131|183093928|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|2.57||||0.6|TWO_SIDED|95.0|-7.85|12.98|||t-test, 2 sided||We subtracted the group mean for the ESC group from that of the COMB-R group. The group mean is the mean of the site-specific percentages of participants with events.|This is the analysis of new Grade 3+ diagnoses through week 24.The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||12.98|-7.85|0.60
91601151|NCT02939131|183093928|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.The group mean is the mean of the site-specific percentages of participants with events as defined above.|Mean Difference (Final Values)|4.4||||0.17|TWO_SIDED|95.0|-2.21|11.02|||t-test, 2 sided||The ESC group mean percent of participants reporting a trigger event was subtracted from the COMB-R group mean.|This is the analysis of the triggering events (psychiatric hospitalizations or suicide attempts) through week 24. A participant is counted once if they had reported any such event prior to the upper bound of the week 24 window. The percent of participants at each site with at least one such event were computed.The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.02|-2.21|0.17
91601152|NCT02939131|183093929|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.98|TWO_SIDED|95.0|-13.85|14.13|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ signs/symptoms through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.13|-13.85|0.98
91601153|NCT02939131|183093929|SUPERIORITY||Mean Difference (Final Values)|5.64||||0.4|TWO_SIDED|95.0|-8.6|19.89|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ diagnoses through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||19.89|-8.60|0.40
91601154|NCT02939131|183093929|SUPERIORITY||Mean Difference (Final Values)|3.01||||0.44|TWO_SIDED|95.0|-5.27|11.29|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new trigger events through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.29|-5.27|0.44
91785644|NCT02633020|183451898|SUPERIORITY||Ratio of LS Means|1.17|STANDARD_ERROR_OF_MEAN|0.24||0.4469|TWO_SIDED|95.0|0.77|1.8|||Generalized Linear Mixed Model|Generalized linear mixed model with subject as a random effect and treatment group, time (week) and their interaction as fixed effects.||||1.8|0.77|0.4469
91601155|NCT03569202|183093930|SUPERIORITY||Mean Difference (Final Values)|1.8837||||0.662|TWO_SIDED|95.0|-6.7081|10.4756||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||10.4756|-6.7081|0.662
91601156|NCT03569202|183093930|OTHER||Mean Difference (Final Values)|-24.6445|||<|0.0001|TWO_SIDED|95.0|-30.7199|-18.5692||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-18.5692|-30.7199|<0.0001
91601157|NCT03569202|183093930|OTHER||Mean Difference (Final Values)|-26.5283|||<|0.0001|TWO_SIDED|95.0|-32.6036|-20.4529||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-20.4529|-32.6036|<0.0001
91601158|NCT03569202|183093931|OTHER||Mean Difference (Final Values)|-2.9808||||0.575|TWO_SIDED|95.0|-13.6005|7.639||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.6390|-13.6005|0.575
91601159|NCT03569202|183093931|OTHER||Mean Difference (Final Values)|-4.75||||0.2098|TWO_SIDED|95.0|-12.2593|2.7593||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7593|-12.2593|0.2098
91601160|NCT03569202|183093931|OTHER||Mean Difference (Final Values)|-1.7692||||0.6381|TWO_SIDED|95.0|-9.2785|5.7401||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||5.7401|-9.2785|0.6381
91601161|NCT03569202|183093932|OTHER||Mean Difference (Final Values)|0.8462||||0.271|TWO_SIDED|95.0|-0.6792|2.3715||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||2.3715|-0.6792|0.271
91601162|NCT03569202|183093932|OTHER||Mean Difference (Final Values)|1.7115||||0.0025|TWO_SIDED|95.0|0.633|2.7901||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7901|0.6330|0.0025
91601163|NCT03569202|183093932|OTHER||Mean Difference (Final Values)|0.8654||||0.1134|TWO_SIDED|95.0|-0.2132|1.944||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.9440|-0.2132|0.1134
91785645|NCT02633020|183451900|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4832|TWO_SIDED|95.0|-0.53|0.26|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and time point-by-treatment group as fixed effects.||||0.26|-0.53|0.4832
91601164|NCT03569202|183093933|OTHER||Mean Difference (Final Values)|2.1731||||0.412|TWO_SIDED|95.0|-3.1016|7.4477||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.4477|-3.1016|0.412
91601165|NCT03569202|183093933|OTHER||Mean Difference (Final Values)|0.01923||||0.9918|TWO_SIDED|95.0|-3.7105|3.749||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||3.7490|-3.7105|0.9918
91601166|NCT03569202|183093933|OTHER||Mean Difference (Final Values)|-2.1538||||0.2516|TWO_SIDED|95.0|-5.8836|1.5759||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.5759|-5.8836|0.2516
91601167|NCT03569202|183093934|OTHER||Mean Difference (Final Values)|0.5093||||0.047|TWO_SIDED|95.0|0.007267|1.0113||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||1.0113|0.007267|0.047
91601168|NCT03569202|183093934|OTHER||Mean Difference (Final Values)|0.5596||||0.0026|TWO_SIDED|95.0|0.2046|0.9146||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.9146|0.2046|0.0026
91601169|NCT03569202|183093934|OTHER||Mean Difference (Final Values)|0.05032||||0.777|TWO_SIDED|95.0|-0.3047|0.4053||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.4053|-0.3047|0.7770
91601170|NCT03569202|183093935|OTHER||Wilcoxon Z statistic|-0.7604||||0.447|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.447
91601171|NCT03569202|183093935|OTHER|||||||0.014||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.014
91601172|NCT03569202|183093935|OTHER|||||||0.07||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.070
91601173|NCT03569202|183093936|OTHER||Wilcoxon Z statistic|-0.6396||||0.522|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.522
91601174|NCT03569202|183093936|OTHER|||||||0.119||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.119
91601175|NCT03569202|183093936|OTHER|||||||0.9||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.900
91601176|NCT03569202|183093937|OTHER||Wilcoxon Z statistic|-0.5387||||0.59|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.590
91601177|NCT03569202|183093937|OTHER|||||||0.043||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.043
91601178|NCT03569202|183093937|OTHER|||||||0.442||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.442
91601179|NCT03569202|183093939|OTHER||Wilcoxon Z statistic|0.9208||||0.357|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.357
91601180|NCT03569202|183093939|OTHER|||||||0.001||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.001
91601181|NCT03569202|183093939|OTHER|||||||0.065||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.065
91601182|NCT03569202|183093940|OTHER||Wilcoxon Z statistic|1.044||||0.296|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.296
91601183|NCT03569202|183093940|OTHER|||||||0.012||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.012
91601184|NCT03569202|183093940|OTHER||||||>|0.05||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||>0.05
91601185|NCT03569202|183093942|OTHER||Mean Difference (Final Values)|-1.9911||||0.764|TWO_SIDED|95.0|-15.6117|11.6295||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||11.6295|-15.6117|0.764
91601186|NCT03569202|183093942|OTHER||Mean Difference (Final Values)|-17.0625||||0.0038|TWO_SIDED|95.0|-27.928|-6.197||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.1970|-27.9280|0.0038
91522699|NCT04425902|182920603|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.75|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.75|
91522700|NCT04425902|182920604|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.76|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.76|
91522701|NCT04425902|182920605|OTHER||Ratio of geometric least square mean|0.85|||||TWO_SIDED|90.0|0.65|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.65|
91522702|NCT01544998|182920621|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.26
91522703|NCT01544998|182920622|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.90
91785646|NCT02633020|183451901|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.24||0.5561|TWO_SIDED|95.0|-0.64|0.35|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and a time point-by-treatment group as fixed effects.||||0.35|-0.64|0.5561
91522704|NCT01544998|182920623|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.003
91522705|NCT01544998|182920624|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.14
91522706|NCT01544998|182920625|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
91522707|NCT01544998|182920626|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
91522708|NCT02940574|182920658|OTHER|Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|||||<|0.08||||||Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|Mixed Models Analysis|(F(1,36)=2.00; p=.08 (one-sided))||||||<0.08
91522709|NCT00520975|182920670|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Cox|||||1.23|0.43|0.24
91522710|NCT00520975|182920671|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.75|TWO_SIDED|95.0|0.61|1.97|||Regression, Cox|||||1.97|0.61|0.75
91522711|NCT04382924|182920684|SUPERIORITY||Odds Ratio, log|0.0001|||<|0.025|TWO_SIDED||||||Chi-squared|||||||<0.025
91522712|NCT00261495|182920701|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|0.29||||0.011||95.0|-0.27|0.84||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.84|-0.27|0.011
91601187|NCT03569202|183093942|OTHER||Mean Difference (Final Values)|-15.0714||||0.0011|TWO_SIDED|95.0|-23.285|-6.8579||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.8579|-23.2850|0.0011
91785647|NCT05661851|183451904|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Least-square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-1.67|13.38|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control.|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||13.38|-1.67|
91785648|NCT05661851|183451905|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Mean Population Difference Estimate|5.843|STANDARD_ERROR_OF_MEAN|4.456|||TWO_SIDED|95.0|-2.8904|14.5768|||Bootstrapping methods||Bootstrap Mean Difference was calculated as Test minus Control|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||14.5768|-2.8904|
91785649|NCT01014910|183451929|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.|Wilcoxon (Mann-Whitney)|Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)||Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||<0.05
91785650|NCT01014910|183451930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|||The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||0.05
91785651|NCT00800254|183451944|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91785652|NCT00800254|183451946|SUPERIORITY_OR_OTHER||||||<|0.003|TWO_SIDED||||||ANCOVA|||||||<0.003
91790512|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91522713|NCT00261495|182920702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.706||95.0|-0.32|0.47||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.47|-0.32|0.706
91785653|NCT00744042|183451952|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Testing whether median change in rickets severity from Baseline to Week 24, measured by RGI-C at Week 24, is from zero.|Wilcoxon signed-rank test|The last post-baseline observation carry forward method is used; patients with no post-baseline assessments were imputed as having no change.||One treatment group||||0.0039
91522714|NCT00261495|182920703|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.53|0.29||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.29|-0.53|<0.001
91522715|NCT00261495|182920704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.87||||0.065||95.0|-5.94|0.19||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.19|-5.94|0.065
91522716|NCT00261495|182920705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.348||95.0|-0.62|0.22||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.22|-0.62|0.348
91522717|NCT00261495|182920706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.616||95.0|-0.54|0.32||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.32|-0.54|0.616
91522718|NCT00261495|182920707|SUPERIORITY_OR_OTHER|||||||0.249||||||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.||"Null hypothesis: There is no association between study medication and dose escalation.~Alternative hypothesis: There is an association between study medication and dose escalation."||||0.249
91522719|NCT00261495|182920708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.05||95.0|0.0|0.84||0.05 two-sided testing, exploratory comparison|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.84|-0.00|0.050
91522720|NCT00261495|182920709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.105||95.0|-0.06|0.67||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-0.06|0.105
91522721|NCT00261495|182920710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.058||95.0|-0.01|0.79||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.79|-0.01|0.058
91785654|NCT02654769|183451957|EQUIVALENCE|Difference (Generic- Picato)|90% Wald's confidence interval|-1.87|||<|0.0001|TWO_SIDED|90.0|-12.37|8.63|||Fisher Exact|||||8.63|-12.37|<0.0001
91785655|NCT02654769|183451958|EQUIVALENCE|Difference (Generic - Picato)|90% Wald's confidence interval|-2.64|||<|0.0001|TWO_SIDED|90.0|-13.14|7.86|||Fisher Exact|||Partial Clearance at Week 8||7.86|-13.14|<0.0001
91785656|NCT02055118|183451961|SUPERIORITY||Least squares mean|3.0|STANDARD_ERROR_OF_MEAN|5.12||0.5669|TWO_SIDED|95.0|-7.3|13.3|||Mixed model repeated measures|||The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to \[\<=\] 70 or \>70), baseline age group (\<6 years or \>=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.||13.3|-7.3|0.5669
91785657|NCT00730028|183452112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7688|TWO_SIDED|95.0|-7.6|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||5.1|-7.6|0.7688
91785658|NCT00730028|183452112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-5.4|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.1|-5.4|1.0000
91601188|NCT03244033|183093959|SUPERIORITY||Odds Ratio (OR)|0.97||||0.91|TWO_SIDED|96.0|0.57|1.64|||Mixed Models Analysis|Adjusted for site (p\<.001) and for whether physician contextualized plan (AOR 2.14, p=.001), and random effects of physician and patient.||Logistic mixed effects regression modeling likelihood of red flag improved/resolved (vs. not) during outcome period with fixed effects of intervention, site, and whether contextual factor was incorporated into care plan, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||1.64|.57|.91
91601189|NCT03244033|183093960|SUPERIORITY||Odds Ratio (OR)|2.09||||0.02|TWO_SIDED|95.0|1.13|3.86|||Mixed Models Analysis|Adjusted for site, source of red flag, visible/concealed recorder, and random effects of physician and patient.|OR\>1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider probing red flag (vs. not) during visit with fixed effects of intervention, site, \\whether red flag was select on pre-visit questionnaire, and whether audiorecorder was visible to provider, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||3.86|1.13|0.02
91601190|NCT03244033|183093961|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.32|5.41|||Mixed Models Analysis|Adjusted for site, source of factor, recorder visible/concealed, and random effects of physician and patient.|OR \> 1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider incorporating contextual factor into care plan (vs. not) at visit with fixed effects of intervention, site, whether red flag was select on pre-visit questionnaire, whether audiorecorder was visible to provider, whether factor was identified by provider probe, whether factor was revealed by patient, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||5.41|1.32|.006
91601191|NCT04428411|183093962|OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
91601192|NCT04428411|183093963|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
91601193|NCT04428411|183093964|OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
91601194|NCT04428411|183093965|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91650208|NCT00575328|183192807|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in MGH-SD score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|4.5||0.38|TWO_SIDED|95.0|-6.7|13.97||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in MGH-SD score) between treatment arms. No formal power analysis was carried out, given the small study sample.|Analysis was not truly informative since the analyzable sample (n=6) was too small. Results should be interpreted with caution.|13.97|-6.7|0.38
91650209|NCT03124381|183192873|NON_INFERIORITY|Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164|||TWO_SIDED|95.0|-7.04|13.42||||||Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.||13.42|-7.04|
91785659|NCT00730028|183452112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-19.2|-5.6||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.6|-19.2|<0.0001
91601195|NCT04428411|183093966|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91790513|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.107|TWO_SIDED|95.0|-0.323|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.031|-0.323|0.107
91601196|NCT04428411|183093967|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
91601197|NCT04428411|183093968|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
91601198|NCT04428411|183093969|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91601199|NCT04428411|183093970|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91601200|NCT04428411|183093971|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
91601201|NCT04428411|183093971|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
91601202|NCT04428411|183093972|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
91601203|NCT04428411|183093972|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
91601204|NCT04428411|183093973|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
91601205|NCT04428411|183093973|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
91601206|NCT02918019|183093993|OTHER||Rate Ratio|0.57||||0.0049|TWO_SIDED|95.0|0.39|0.84|||Poisson regression|||||0.84|0.39|0.0049
91601207|NCT02918019|183093993|OTHER||Rate Ratio|0.78||||0.1838|TWO_SIDED|95.0|0.54|1.12|||Poisson regression|||||1.12|0.54|0.1838
91601208|NCT02918019|183093993|OTHER||Rate Ratio|0.63||||0.0144|TWO_SIDED|95.0|0.44|0.91|||Poisson regression|||||0.91|0.44|0.0144
91601209|NCT00094757|183094008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.82|-0.39||Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|ANCOVA|||||-0.39|-0.82|<0.001
91601210|NCT00094757|183094008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.7|-0.26|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)||||-0.26|-0.70|<0.001
91601211|NCT00094757|183094009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.7|STANDARD_DEVIATION|45.9|<|0.001|TWO_SIDED|95.0|-30.5|-8.9|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-8.9|-30.5|<0.001
91601212|NCT00094757|183094009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.9|STANDARD_DEVIATION|45.9|<|0.002|TWO_SIDED|95.0|-27.6|-6.1|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-6.1|-27.6|<0.002
91601213|NCT00523991|183094184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.27||"There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.~Mean Difference (Final Values) means difference in LS-Means"|ANCOVA|The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.||||0.27|0.18|<0.001
91601214|NCT00523991|183094188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.18|0.09|<0.001
91601215|NCT00523991|183094192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.19|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.29|0.19|<0.001
91790514|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.59|||TWO_SIDED|||||||||Week 72||||
91790515|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.961|TWO_SIDED|95.0|-0.243|0.232||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.232|-0.243|0.961
91790516|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790517|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.618|TWO_SIDED|95.0|-0.29|0.173||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.173|-0.290|0.618
91790518|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790519|NCT02880956|183460067|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.121||0.227|TWO_SIDED|95.0|-0.385|0.092||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.092|-0.385|0.227
91790520|NCT02880956|183460067|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||Week 96||||
91790521|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.056|TWO_SIDED|95.0|-0.009|0.697||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.697|-0.009|0.056
91790522|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.23|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790523|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.177||0.997|TWO_SIDED|95.0|-0.348|0.349||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.349|-0.348|0.997
91790524|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.34|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790525|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.41|STANDARD_ERROR_OF_MEAN|0.182||0.023|TWO_SIDED|95.0|0.056|0.772||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.772|0.056|0.023
91790526|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.3|STANDARD_DEVIATION|1.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790527|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.212||0.502|TWO_SIDED|95.0|-0.274|0.558||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.558|-0.274|0.502
91790528|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790529|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.206||0.379|TWO_SIDED|95.0|-0.587|0.224||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.224|-0.587|0.379
91790530|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790531|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.212||0.916|TWO_SIDED|95.0|-0.439|0.394||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.394|-0.439|0.916
91790532|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91601216|NCT00523991|183094208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"Terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.18|0.09|<0.001
91601217|NCT00523991|183094209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.001||95.0|0.16|0.25||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.25|0.16|<0.001
91601218|NCT00523991|183094210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium vesus placebo||0.28|0.18|<0.001
91601219|NCT00523991|183094211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.2|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.29|0.20|<0.001
91709439|NCT04633291|183311484|SUPERIORITY||Odds Ratio (OR)|7.17||||0.269|TWO_SIDED|95.0|0.19|265.95||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||265.95|0.19|0.269
91601220|NCT00523991|183094212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001||95.0|0.2|0.3||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.30|0.20|<0.001
91522722|NCT00261495|182920711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.21||95.0|-0.13|0.59||0.05 two-sided test|ANCOVA||Mean difference calculated: hdromorphone minus oxycodone|Exploratory comparison||0.59|-0.13|0.210
91601221|NCT00523991|183094216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|||<|0.001||95.0|0.24|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.24|<0.001
91601222|NCT00523991|183094220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and trough forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.28|0.14|<0.001
91601223|NCT00523991|183094224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.24|0.42||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.42|0.24|<0.001
91785660|NCT00730028|183452112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.0002|TWO_SIDED|95.0|-19.1|-5.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.4|-19.1|0.0002
91601224|NCT00523991|183094240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.28|0.14|<0.001
91601225|NCT00523991|183094241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||<|0.001||95.0|0.21|0.36||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.36|0.21|<0.001
91601226|NCT00523991|183094242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.001||95.0|0.23|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.23|<0.001
91601227|NCT00523991|183094243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.25|0.4||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.40|0.25|<0.001
91650210|NCT03124381|183192873|SUPERIORITY|Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164||0.538|TWO_SIDED|95.0|-7.04|13.42|||ANCOVA|||Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.||13.42|-7.04|0.538
91650211|NCT02473510|183192916|SUPERIORITY_OR_OTHER||Rate Difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6||||||||2.6|-5.2|
91650212|NCT02473510|183192917|SUPERIORITY_OR_OTHER||Rate Difference|16.7|||||TWO_SIDED|95.0|3.6|27.6||||||Up to Day 8||27.6|3.6|
91650213|NCT02473510|183192917|SUPERIORITY_OR_OTHER||Rate Difference|17.9|||||TWO_SIDED|95.0|4.4|29.3||||||Up to Day 15||29.3|4.4|
91601228|NCT00523991|183094244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||<|0.001||95.0|0.26|0.45||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.45|0.26|<0.001
91650214|NCT00500656|183192939|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.475|||<|0.001|TWO_SIDED|95.0|1.901|6.355|||The Wilcoxon version of the log rank|The median time to onset was calculated using Kaplan Meier methodology. The Wilcoxon version of the log rank test of SAS was used||||6.355|1.901|< 0.001
91650215|NCT00500656|183192940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||The Wilcoxon version of the log rank|The median time to almost complete symptom relief was calculated using Kaplan Meier methodology.The Wilcoxon version of the log rank test SAS was used||||||< 0.001
91785661|NCT00730028|183452115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.52|TWO_SIDED|95.0|-10.2|4.9||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||4.9|-10.2|0.5200
91601229|NCT00523991|183094251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.927||95.0|-0.38|0.41||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and albuterol use at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.41|-0.38|0.927
91601230|NCT00523991|183094252|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.174
91601231|NCT00523991|183094253|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.186
91650216|NCT01806597|183192951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.3||||0.0002|TWO_SIDED|95.0|2.4|154.6|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||154.6|2.4|0.0002
91785662|NCT00730028|183452115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.7324|TWO_SIDED|95.0|-8.4|5.7||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.7|-8.4|0.7324
91785663|NCT00730028|183452115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2||||0.0001|TWO_SIDED|95.0|-22.0|-6.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-6.4|-22.0|0.0001
91785664|NCT00730028|183452115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9||||0.0008|TWO_SIDED|95.0|-20.8|-5.0||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.0|-20.8|0.0008
91785665|NCT00730028|183452116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7707|TWO_SIDED|95.0|-7.1|5.3||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||5.3|-7.1|0.7707
91785666|NCT00730028|183452116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.2141|TWO_SIDED|95.0|-2.0|8.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.5|-2.0|0.2141
91785667|NCT00730028|183452116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0593|TWO_SIDED|95.0|-12.4|0.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.5|-12.4|0.0593
91785668|NCT00730028|183452116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0017|TWO_SIDED|95.0|-15.3|-3.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.1|-15.3|0.0017
91785669|NCT00730028|183452117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1381|TWO_SIDED|95.0|-13.1|1.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.8|-13.1|0.1381
91785670|NCT00730028|183452117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.8302|TWO_SIDED|95.0|-6.4|8.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.2|-6.4|0.8302
91785671|NCT00730028|183452117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0838|TWO_SIDED|95.0|-14.3|1.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||1.1|-14.3|0.0838
91785672|NCT00730028|183452117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.0507|TWO_SIDED|95.0|-15.2|0.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.2|-15.2|0.0507
91785673|NCT00730028|183452118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1505|TWO_SIDED|95.0|-13.3|1.9||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.9|-13.3|0.1505
91790533|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.487|TWO_SIDED|95.0|-0.633|0.302||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.302|-0.633|0.487
91790534|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790535|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.235||0.963|TWO_SIDED|95.0|-0.451|0.473||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.473|-0.451|0.963
91790536|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790537|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.238||0.856|TWO_SIDED|95.0|-0.424|0.51||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.510|-0.424|0.856
91601232|NCT00523991|183094254|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.045
91601233|NCT00523991|183094255|SUPERIORITY_OR_OTHER|||||||0.223||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.223
91601234|NCT00523991|183094256|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.010
91601235|NCT00523991|183094257|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.086
91601236|NCT00523991|183094259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.729||95.0|-2.97|4.24||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||4.24|-2.97|0.729
91601237|NCT00523991|183094260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.149||95.0|-5.9|0.9||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.90|-5.90|0.149
91601238|NCT00523991|183094261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.763||95.0|-4.0|2.93||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.93|-4.00|0.763
91601239|NCT00523991|183094262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.313||95.0|-5.45|1.75||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||1.75|-5.45|0.313
91601240|NCT00523991|183094263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.682||95.0|-4.6|3.01||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||3.01|-4.60|0.682
91601241|NCT00523991|183094264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76||||0.043||95.0|-7.39|-0.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||-0.13|-7.39|0.043
91601242|NCT00523991|183094266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.823||95.0|-6.01|4.79||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.79|-6.01|0.823
91601243|NCT00523991|183094267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.767||95.0|-7.86|5.81||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.81|-7.86|0.767
91601244|NCT00523991|183094268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.754||95.0|-4.12|5.67||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.67|-4.12|0.754
91601245|NCT00523991|183094269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.995||95.0|-6.31|6.27||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.27|-6.31|0.995
91601246|NCT00523991|183094270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.72||95.0|-7.77|5.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.39|-7.77|0.720
91601247|NCT00523991|183094271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88||||0.064||95.0|-12.1|0.35||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.35|-12.10|0.064
91785674|NCT00730028|183452118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1666|TWO_SIDED|95.0|-10.9|2.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.2|-10.9|0.1666
91785675|NCT00730028|183452118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.0001|TWO_SIDED|95.0|-23.0|-8.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-8.0|-23.0|<0.0001
91601248|NCT00523991|183094273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.718||95.0|-7.21|4.98||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.98|-7.21|0.718
91601249|NCT00523991|183094274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.912||95.0|-7.9|7.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.06|-7.90|0.912
91601250|NCT00523991|183094275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.162||95.0|-1.55|9.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.13|-1.55|0.162
91650217|NCT01806597|183192951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.4|||<|0.0001|TWO_SIDED|95.0|4.1|211.9|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||211.9|4.1|<0.0001
91650218|NCT01473758|183192967|SUPERIORITY_OR_OTHER||LS Mean Difference|1.404|STANDARD_ERROR_OF_MEAN|3.07||0.6491|TWO_SIDED|95.0|-4.731|7.538||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||7.538|-4.731|0.6491
91650219|NCT01473758|183192968|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.412|STANDARD_ERROR_OF_MEAN|2.687||0.8786|TWO_SIDED|95.0|-5.766|4.943||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||4.943|-5.766|0.8786
91650220|NCT02763579|183193025|SUPERIORITY||Stratified Hazard Ratio|0.77||||0.017|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||||0.96|0.62|0.0170
91650221|NCT02763579|183193026|SUPERIORITY||Stratified Hazard Ratio|0.7||||0.0069|TWO_SIDED|95.0|0.54|0.91|||Log Rank|||||0.91|0.54|0.0069
91650222|NCT02763579|183193027|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||||1.37|0.55|
91650223|NCT02763579|183193028|SUPERIORITY||Hazard Ratio (HR)|0.715||||0.0063|TWO_SIDED|95.0|0.562|0.911|||Log Rank|||||0.911|0.562|0.0063
91650224|NCT02763579|183193029|SUPERIORITY||Difference in Event Free Rate|8.47||||0.0593|TWO_SIDED|95.0|-0.33|17.27|||Z-test|||PFS Rate at 6 months||17.27|-0.33|0.0593
91522723|NCT00261495|182920712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.941||95.0|-4.87|4.52||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.52|-4.87|0.941
91601251|NCT00523991|183094276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59||||0.471||95.0|-4.51|9.69||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.69|-4.51|0.471
91650225|NCT02763579|183193029|SUPERIORITY||Difference in Event Free Rate|7.27||||0.0133|TWO_SIDED|95.0|1.52|13.02|||Z-test|||PFS Rate at 1 year||13.02|1.52|0.0133
91650226|NCT02763579|183193030|SUPERIORITY||Difference in Event Free Rate|13.46||||0.0095|TWO_SIDED|95.0|3.29|23.64|||Z-test|||OS Rate at 1 year||23.64|3.29|0.0095
91650227|NCT02763579|183193031|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.221||||0.3604|TWO_SIDED|95.0|0.795|1.874|||Log Rank|||Cough||1.874|0.795|0.3604
91650228|NCT02763579|183193031|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.058||||0.7712|TWO_SIDED|95.0|0.722|1.553|||Log Rank|||Pain in Chest||1.553|0.722|0.7712
91650229|NCT02763579|183193031|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.077||||0.6922|TWO_SIDED|95.0|0.747|1.552|||Log Rank|||Pain in Arm or Shoulder||1.552|0.747|0.6922
91650230|NCT02763579|183193031|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|0.748||||0.065|TWO_SIDED|95.0|0.549|1.019|||Log Rank|||Dyspnea||1.019|0.549|0.0650
91601252|NCT00523991|183094277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.961||95.0|-6.52|6.84||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.84|-6.52|0.961
91601253|NCT00523991|183094278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.158||95.0|-11.73|1.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||1.94|-11.73|0.158
91650231|NCT00936377|183193038|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91650232|NCT00936377|183193038|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91650233|NCT00936377|183193039|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91650234|NCT00936377|183193039|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91650235|NCT00936377|183193040|SUPERIORITY_OR_OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
91650236|NCT00936377|183193040|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91650237|NCT00936377|183193041|SUPERIORITY_OR_OTHER|||||||0.18||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||Percentage of CIWA scores rates as severe||||0.18
91650238|NCT00936377|183193041|SUPERIORITY_OR_OTHER|||||||0.35||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||||||0.35
91522724|NCT00261495|182920713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.073||95.0|-0.03|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.03|0.073
91650239|NCT00936377|183193042|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For hypotension||||1
91650240|NCT00936377|183193042|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||For hypotension||||0.47
91601254|NCT00523991|183094280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74||||0.469||95.0|-3.01|6.49||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.49|-3.01|0.469
91650241|NCT00936377|183193042|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For bradycardia||||1
91601255|NCT00523991|183094281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.79||||0.079||95.0|-0.68|12.26||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||12.26|-0.68|0.079
91601256|NCT00523991|183094282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.051||95.0|-0.02|8.23||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||8.23|-0.02|0.051
91650242|NCT00936377|183193042|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||For bradycardia||||0.2
91650243|NCT00936377|183193043|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Repeated measures ANOVA|||||||<0.05
91650244|NCT00936377|183193044|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91650245|NCT00936377|183193044|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91650246|NCT00936377|183193045|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91650247|NCT00936377|183193045|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91650248|NCT00829413|183193046|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|37.8|||<|0.0001|TWO_SIDED|95.0|27.4|48.2|||McNemar|||||48.2|27.4|<.0001
91650249|NCT00829413|183193046|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|40.3|||<|0.0001|TWO_SIDED|95.0|30.4|50.3|||McNemar|||||50.3|30.4|<.0001
91601257|NCT00523991|183094283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.075||95.0|-0.35|7.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.21|-0.35|0.075
91650250|NCT00829413|183193046|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
91650251|NCT00829413|183193047|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|7.9||||0.138|TWO_SIDED|95.0|-2.4|18.2|||McNemar|||||18.2|-2.4|0.1380
91650252|NCT00829413|183193047|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|28.6|||<|0.0001|TWO_SIDED|95.0|19.7|37.5|||McNemar|||||37.5|19.7|<.0001
91650253|NCT00829413|183193047|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|50.7|||<|0.0001|TWO_SIDED|95.0|42.0|59.5|||McNemar|||||59.5|42.0|<.0001
91650254|NCT00829413|183193048|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|21.6|||<|0.0001|TWO_SIDED|95.0|14.1|29.2|||McNemar|||||29.2|14.1|<.0001
91650255|NCT00829413|183193048|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|34.0|||<|0.0001|TWO_SIDED|95.0|27.3|40.7|||McNemar|||||40.7|27.3|<.0001
91650256|NCT00829413|183193048|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
91650257|NCT00829413|183193049|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91650258|NCT00829413|183193049|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91650259|NCT00829413|183193049|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91650260|NCT00829413|183193050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91650261|NCT00829413|183193050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91650262|NCT00829413|183193050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91709440|NCT04633291|183311485|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.02|64.83||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||64.83|0.02|1.0
91601258|NCT00523991|183094284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.306||95.0|-1.39|4.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and work productivity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||4.38|-1.39|0.306
91601259|NCT00523991|183094285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.363||95.0|-7.39|2.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.73|-7.39|0.363
91601260|NCT00523991|183094287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.668||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and logarithm of baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.02|-0.03|0.668
91601261|NCT00523991|183094288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.78||95.0|-0.02|0.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.03|-0.02|0.780
91601262|NCT00523991|183094289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.61||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.03|0.610
91601263|NCT00523991|183094290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.554||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.554
91601264|NCT00523991|183094291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.549||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.549
91650263|NCT00294723|183193059|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.62|||<|0.0001||95.0|-0.83|-0.42||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.42|-0.83|<0.0001
91650264|NCT00294723|183193059|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.0014||95.0|-0.53|-0.13||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.13|-0.53|0.0014
91650265|NCT00294723|183193059|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0046||95.0|-0.5|-0.09||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.09|-0.50|0.0046
91650266|NCT00294723|183193060|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.58|||<|0.0001||95.0|-4.28|-2.87||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.87|-4.28|<.0001
91785676|NCT00730028|183452118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.0046|TWO_SIDED|95.0|-19.0|-3.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.2|-19.0|0.0046
91601265|NCT00523991|183094292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.568||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.568
91785677|NCT00730028|183452119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.1815|TWO_SIDED|95.0|-13.6|2.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||2.8|-13.6|0.1815
91785678|NCT00730028|183452119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.1552|TWO_SIDED|95.0|-13.2|2.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.1|-13.2|0.1552
91522725|NCT00261495|182920714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.431||95.0|-0.52|0.22||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.22|-0.52|0.431
91601266|NCT00523991|183094294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.358||95.0|-0.18|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.07|-0.18|0.358
91601267|NCT00523991|183094295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.219||95.0|-0.2|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.05|-0.20|0.219
91601268|NCT00523991|183094296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.518||95.0|-0.1|0.19||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.19|-0.10|0.518
91601269|NCT00523991|183094297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.455||95.0|-0.09|0.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.21|-0.09|0.455
91601270|NCT00523991|183094298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|-0.16|0.15||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.15|-0.16|0.927
91601271|NCT00523991|183094299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.933||95.0|-0.17|0.16||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.16|-0.17|0.933
91601272|NCT00523991|183094300|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.996
91601273|NCT00523991|183094301|SUPERIORITY_OR_OTHER|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.196
91601274|NCT00523991|183094302|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.800
91601275|NCT00523991|183094303|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.215
91601276|NCT00523991|183094304|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.205
91785679|NCT00730028|183452119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||<|0.0001|TWO_SIDED|95.0|-24.0|-7.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-7.8|-24.0|<0.0001
91790538|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91601277|NCT00523991|183094305|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.622
91601278|NCT00523991|183094306|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.446
91601279|NCT00523991|183094308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.819||95.0|-0.05|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.05|0.819
91601280|NCT00523991|183094309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.204||95.0|-0.1|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.10|0.204
91601281|NCT00523991|183094310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.67||95.0|-0.08|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.05|-0.08|0.670
91601282|NCT00523991|183094311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.63||95.0|-0.09|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.09|0.630
91601283|NCT00523991|183094312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.704||95.0|-0.1|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.07|-0.10|0.704
91601284|NCT00523991|183094313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.579||95.0|-0.11|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.06|-0.11|0.579
91601285|NCT00523991|183094315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.54||||0.916||95.0|-464.02|416.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||416.94|-464.02|0.916
91601286|NCT00523991|183094316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.42||||0.899||95.0|-520.19|457.34||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||457.34|-520.19|0.899
91601287|NCT00523991|183094317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|181.99||||0.495||95.0|-341.75|705.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||placebo versus tiotropium||705.73|-341.75|0.495
91601288|NCT00523991|183094318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|258.83||||0.318||95.0|-250.37|768.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||768.03|-250.37|0.318
91601289|NCT00523991|183094319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.18||||0.45||95.0|-338.04|760.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||760.39|-338.04|0.450
91601290|NCT00523991|183094320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.46||||0.858||95.0|-512.2|615.12||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||615.12|-512.20|0.858
91601291|NCT03439033|183094322|SUPERIORITY||Risk Difference (RD)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||McNemar||Risk difference reflects PSMA PET/MRI Scan detection proportion minus MRI scan detection proportion.|||0.53|0.30|<0.0001
91601292|NCT02435849|183094350|OTHER|testing the null hypothesis that ORR within 3 months is less than or equal to 20%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
91601293|NCT02435849|183094352|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
91601294|NCT02435849|183094353|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
91601295|NCT03979274|183094389|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|98.53|||||TWO_SIDED|90.0|94.55|102.68||||||||102.68|94.55|
91601296|NCT03979274|183094390|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|97.59|||||TWO_SIDED|90.0|91.34|104.26||||||||104.26|91.34|
91601297|NCT03979274|183094393|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.73|||||TWO_SIDED|90.0|98.45|101.03||||||||101.03|98.45|
91601298|NCT03979274|183094394|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.26|||||TWO_SIDED|90.0|97.7|100.85||||||||100.85|97.70|
91601299|NCT00632853|183094410|SUPERIORITY|||||||0.8741|||||||Log Rank|||||||0.8741
91601300|NCT01724528|183094422|SUPERIORITY_OR_OTHER||Least squares means difference|-196.794|||<|0.0001|TWO_SIDED|95.0|-238.6|-154.988|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||-154.988|-238.600|<0.0001
91785680|NCT00730028|183452119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0145|TWO_SIDED|95.0|-18.7|-2.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-2.0|-18.7|0.0145
91601301|NCT01724528|183094423|SUPERIORITY_OR_OTHER||Least squares means difference|4.097||||0.0903|TWO_SIDED|95.0|-0.6467|8.8406|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||8.8406|-0.6467|0.0903
91601302|NCT01724528|183094424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0231||||0.1993|TWO_SIDED|95.0|-0.0153|0.0654|||Wilson's confidence interval|||||0.0654|-0.0153|0.1993
91601303|NCT01724528|183094425|SUPERIORITY_OR_OTHER||Relative risk|0.875||||0.8488|TWO_SIDED|95.0|0.4408|1.7369|||Chi-squared|||||1.7369|0.4408|0.8488
91601304|NCT01724528|183094426|SUPERIORITY_OR_OTHER||Relative risk|0.994||||1|TWO_SIDED|95.0|0.9691|1.0199|||Chi-squared|||||1.0199|0.9691|1.0000
91601305|NCT00466310|183094428|SUPERIORITY_OR_OTHER|||||||0.0149|TWO_SIDED|95.0||||Unadjusted p value is .0041|Wilcoxon (Mann-Whitney)|||A wilcoxon rank sum test was performed comparing baseline plasmalogen values, comparing schizophrenia subjects vs controls.P values from this analysis were adjusted for false discovery rates by the method of Storey and Tribshiani.||||0.0149
91601306|NCT01493180|183094430|SUPERIORITY_OR_OTHER|||||||0.576|||||||t-test, 2 sided|||||||0.576
91601307|NCT05574062|183094431|NON_INFERIORITY|-7.5% non-inferiority margin|Mean Difference (Final Values)|9.88|||||TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|
91601308|NCT05574062|183094432|NON_INFERIORITY|non-inferiority margin of 0.4% HbA1c|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (continuation phase period1) values|||0.31|-0.03|
91601309|NCT05574062|183094433|NON_INFERIORITY|non- inferiority margin of 0.4%|Mean Difference (Final Values)|-0.61|||||TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|
91601310|NCT05574062|183094434|SUPERIORITY||Median Difference (Final Values)|9.88|||<|0.0001|TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|<.0001
91601311|NCT05574062|183094435|SUPERIORITY||Mean Difference (Net)|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|<.0001
91601312|NCT05574062|183094436|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.1097|TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (period1) values|||0.31|-0.03|0.1097
91601313|NCT05574062|183094437|NON_INFERIORITY|non inferiority margin of -7.5%|Mean Difference (Net)|1.17|||||TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|
91601314|NCT05574062|183094438|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.0581|TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|0.0581
91601315|NCT02288273|183094457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91601316|NCT03216382|183094504|SUPERIORITY|||||||0.93||||||The apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.93
91601317|NCT03216382|183094505|SUPERIORITY|||||||0.74||||||this value represents the interaction between condition and the intervention time period The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.74
91601318|NCT03216382|183094505|SUPERIORITY|||||||0.44||||||this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.44
91601319|NCT03216382|183094506|SUPERIORITY|||||||0.17||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.17
91601320|NCT03216382|183094507|SUPERIORITY|||||||0.5||||||The apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time .|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.50
91601321|NCT03216382|183094507|SUPERIORITY|||||||0.02||||||The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared).|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.02
91601322|NCT03216382|183094508|SUPERIORITY|||||||0.46||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.46
91601323|NCT03216382|183094509|SUPERIORITY|||||||0.53||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.53
91601324|NCT03216382|183094510|SUPERIORITY|||||||0.07||||||the apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.07
91601325|NCT03216382|183094511|SUPERIORITY|||||||0.58||||||the apriori threshold for significance was 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.58
91601326|NCT03216382|183094512|SUPERIORITY|||||||0.86||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.86
91601327|NCT03216382|183094513|SUPERIORITY|||||||0.39||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.39
91601328|NCT00454779|183094569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.051|TWO_SIDED|95.0|0.395|1.002|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.002|0.395|0.051
91601329|NCT00454779|183094569|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|Stratified by IVRS randomization factors||||||0.048
91522726|NCT00261495|182920715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.835||95.0|-0.4|0.33||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.33|-0.40|0.835
91601330|NCT00454779|183094570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.23|||||TWO_SIDED|95.0|-11.67|24.12|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||24.12|-11.67|
91601331|NCT00454779|183094570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||||95.0|0.57|3.33|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||3.33|0.57|
91601332|NCT00454779|183094571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-8.29|23.85|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||23.85|-8.29|
91601333|NCT00454779|183094571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||||95.0|0.62|5.26|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||5.26|0.62|
91601334|NCT00454779|183094574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.663|TWO_SIDED|95.0|0.709|1.717|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone|||1.717|0.709|0.663
91601335|NCT00454779|183094574|SUPERIORITY_OR_OTHER|||||||0.666|||||||Log Rank|Stratified by IVRS randomization factors||||||0.666
91601336|NCT01337973|183094583|SUPERIORITY||Coefficient estimate|0.82|||<|0.001|TWO_SIDED|95.0|0.37|1.84||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z value: -4.65|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.84|0.37|<0.001
91650267|NCT00294723|183193060|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.17|||<|0.0001||95.0|-3.87|-2.47||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.47|-3.87|<.0001
91650268|NCT00294723|183193060|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.41||||0.2584||95.0|-1.11|0.3||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.30|-1.11|0.2584
91650269|NCT00294723|183193061|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.65|||<|0.0001||95.0|-4.44|-2.86||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.86|-4.44|<.0001
91650270|NCT00294723|183193061|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.84|||<|0.0001||95.0|-3.63|-2.06||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.06|-3.63|<.0001
91650271|NCT00294723|183193061|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.8||||0.0462||95.0|-1.59|-0.01||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.01|-1.59|0.0462
91601337|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|0.62|||<|0.01|TWO_SIDED|95.0|0.3|1.29||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.83|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||1.29|0.30|<0.01
91601338|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|1.16|||<|0.01|TWO_SIDED|95.0|0.36|3.77||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.31|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||3.77|0.36|<0.01
91601339|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|0.51|||<|0.05|TWO_SIDED|95.0|0.19|1.38||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.26|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.38|0.19|<0.05
91522727|NCT00261495|182920716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.837||95.0|-5.36|4.35||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.35|-5.36|0.837
91601340|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|1.22|||<|0.001|TWO_SIDED|95.0|0.66|2.28||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.79|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.28|0.66|<0.001
91601341|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|0.8|||<|0.05|TWO_SIDED|95.0|0.32|1.98||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.01|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||1.98|0.32|<0.05
91601342|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|0.6|||<|0.001|TWO_SIDED|95.0|0.25|1.46||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.46|0.25|<0.001
91601343|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|1.05|||<|0.001|TWO_SIDED|95.0|0.45|2.44||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.74|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||2.44|0.45|<0.001
91601344|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|0.48|||<|0.01|TWO_SIDED|95.0|0.13|1.78||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.59|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||1.78|0.13|<0.01
91601345|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|0.48|||>|0.05|TWO_SIDED|95.0|0.16|1.47||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -1.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.47|0.16|>0.05
91601346|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|1.12|||<|0.001|TWO_SIDED|95.0|0.6|2.08||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.10|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.08|0.60|<0.001
91601347|NCT01337973|183094583|SUPERIORITY||Coefficient Estimate|1.09|||<|0.01|TWO_SIDED|95.0|0.4|2.95||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.17|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||2.95|0.40|<0.01
91601348|NCT01337973|183094583|SUPERIORITY||||||<|0.001||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.69||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||||<0.001
91601349|NCT01337973|183094583|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.32||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline||||<0.01
91601350|NCT01337973|183094583|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.90||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||||<0.01
91601351|NCT01337973|183094583|SUPERIORITY||||||>|0.05||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -1.02||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||||>0.05
91601352|NCT01337973|183094583|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -4.01||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||||<0.01
91601353|NCT01337973|183094583|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.21||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline||||<0.01
91790539|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.277||0.463|TWO_SIDED|95.0|-0.341|0.748||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.748|-0.341|0.463
91650272|NCT00294723|183193062|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6|||<|0.0001||95.0|-0.83|-0.38||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.38|-0.83|<.0001
91785681|NCT01250496|183452121|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.45||||0.04|TWO_SIDED|95.0|0.2|0.98||No adjustment for multiple comparisons was performed. The threshold for statistical significance was \< 0.05|Chi-squared|||null hypothesis: aminophylline administration does not reduce the incidence of the primary endpoint as compared to placebo. The chi-square test was used to compare event rate between the study arm.||0.98|0.2|0.04
91785682|NCT01250496|183452122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.2|0.7||P value is not adjusted for multiple comparisons.|Chi-squared|||"null hypothesis: the rate of regadenoson adverse effects (global symptomatic burden) in the aminophylline and placebo group are not statistically different.~The chi-square test was used for comparison."||0.7|0.2|< 0.001
91785683|NCT01425463|183452159|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.|LS-Mean of ANCOVA|-2.19|||||TWO_SIDED|95.0|-8.47|4.09||||||||4.09|-8.47|
91785684|NCT03467152|183452167|SUPERIORITY|||||||0.6909||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6909
91785685|NCT03467152|183452168|SUPERIORITY||Odds Ratio (OR)|1.018||||0.8251|TWO_SIDED|95.0|0.695|1.492||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.492|0.695|0.8251
91785686|NCT03467152|183452169|SUPERIORITY||Odds Ratio (OR)|0.853||||0.3003|TWO_SIDED|95.0|0.584|1.247||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.247|0.584|0.3003
91650273|NCT00294723|183193062|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% CI for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.31||||0.0076||95.0|-0.54|-0.08||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.08|-0.54|0.0076
91785687|NCT03467152|183452170|SUPERIORITY|||||||0.9198||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.9198
91785688|NCT03467152|183452171|SUPERIORITY|||||||0.2909|||||||ANCOVA|||||||0.2909
91785689|NCT03467152|183452172|SUPERIORITY|||||||0.6127||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6127
91785690|NCT03467152|183452173|SUPERIORITY|||||||0.878||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8780
91785691|NCT03467152|183452174|SUPERIORITY|||||||0.409||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.4090
91785692|NCT03467152|183452175|SUPERIORITY|||||||0.8736||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8736
91785693|NCT01236547|183452194|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2831|TWO_SIDED|95.0|0.52|1.43||One-sided significance level = 0.1379|Log Rank||Reference arm = placebo|Assuming hazard ratio (pazopanib/placebo) of 0.625 (1-year 19% vs. 35.4%), 1-sided alpha 0.15, logrank test, 80% power, 1 interim analysis, required 71 deaths in 79 eligible patients (88 allowing 10% ineligible) in original design. The protocol was amended for phase II final analysis to be performed after all phase II eligible participants were potentially followed for 3 years with 1-sided alpha 0.1379, providing 77% power. See Limitations and Caveats||1.43|0.52|0.2831
91785694|NCT01236547|183452196|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.688|TWO_SIDED|95.0|0.55|2.67|||Log Rank|One-sided significance level = 0.15|Reference arm = placebo|||2.67|0.55|0.6880
91785695|NCT01236547|183452197|SUPERIORITY|||||||0.1921||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.1921
91785696|NCT01236547|183452198|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
91785697|NCT01236547|183452199|SUPERIORITY|||||||1|||||||Fisher Exact|Two-sided significance level = 0.05||||||1.00
91522728|NCT00261495|182920717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.832||95.0|-0.38|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.38|0.832
91785698|NCT00538785|183452205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.746|||||TWO_SIDED|95.0|0.344|1.586|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.586|0.344|
91785699|NCT00538785|183452206|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.495|||||TWO_SIDED|95.0|0.101|1.989|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.989|0.101|
91650274|NCT00294723|183193062|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0129||95.0|-0.52|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.52|0.0129
91650275|NCT00294723|183193063|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.48|||<|0.0001||95.0|-4.28|-2.68||2-sided significance level was 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.68|-4.28|<0.0001
91650276|NCT00294723|183193063|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.72|||<|0.0001||95.0|-3.52|-1.93||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.93|-3.52|<0.0001
91650277|NCT00294723|183193063|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.75||||0.0642||95.0|-1.55|0.05||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.||0.05|-1.55|0.0642
91650278|NCT00294723|183193064|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-20.28|||<|0.0001||95.0|-29.09|-11.46||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-11.46|-29.09|<.0001
91650279|NCT00294723|183193064|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-9.92||||0.027||95.0|-18.7|-1.12||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.12|-18.70|0.0270
91650280|NCT00294723|183193064|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-10.36||||0.0223||95.0|-19.24|-1.48||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.48|-19.24|0.0223
91785700|NCT03083990|183452231|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9502|||>|0.05|TWO_SIDED|90.0|0.8921|1.012|||ANOVA|||||1.0120|0.8921|>0.05
91785701|NCT03083990|183452232|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9483|||>|0.05|TWO_SIDED|90.0|0.8896|1.0108|||ANOVA|||||1.0108|0.8896|>0.05
91522729|NCT00261495|182920718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.143||95.0|-0.1|0.71||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.71|-0.10|0.143
91785702|NCT03083990|183452233|EQUIVALENCE||Odds Ratio (OR)|0.9749|||>|0.05|TWO_SIDED|90.0|0.9123|1.0418|||ANOVA|||||1.0418|0.9123|>0.05
91785703|NCT00835211|183452268|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|97.5||||||90.0|87.8|108.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.3|87.8|
91785704|NCT00835211|183452269|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|95.6||||||90.0|86.9|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.2|86.9|
91522730|NCT00261495|182920719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.345||95.0|-0.23|0.64||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.64|-0.23|0.345
91522731|NCT00261495|182920720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.552||95.0|-0.33|0.61||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.61|-0.33|0.552
91522732|NCT00261495|182920721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.042||95.0|0.02|0.93||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.93|0.02|0.042
91601354|NCT01337973|183094584|SUPERIORITY||Coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.62|1.47||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.52|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.47|0.62|<0.001
91601355|NCT01337973|183094584|SUPERIORITY||coefficient estimate|0.49|||<|0.01|TWO_SIDED|95.0|0.18|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.98|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||1.32|0.18|<0.01
91601356|NCT01337973|183094584|SUPERIORITY||coefficient estimate|0.85|||<|0.05|TWO_SIDED|95.0|0.4|1.8||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.13|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||1.8|0.4|<0.05
91601357|NCT01337973|183094584|SUPERIORITY||coefficient estimate|0.84|||<|0.05|TWO_SIDED|95.0|0.54|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.48|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.32|0.54|<0.05
91601358|NCT01337973|183094584|SUPERIORITY||coefficient estimate|1.15|||<|0.001|TWO_SIDED|95.0|0.78|1.71||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.94|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.71|0.78|<0.001
91601359|NCT01337973|183094584|SUPERIORITY||coefficient estimate|0.61|||<|0.05|TWO_SIDED|95.0|0.17|2.16||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.56|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||2.16|0.17|<0.05
91601360|NCT01337973|183094584|SUPERIORITY||coefficient estimate|1.18|||<|0.01|TWO_SIDED|95.0|0.57|2.44||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.86|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||2.44|0.57|<0.01
91601361|NCT01337973|183094584|SUPERIORITY||coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.61|1.48||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.51|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.48|0.61|<0.001
91601362|NCT01337973|183094584|SUPERIORITY||||||<|0.001||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.65||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||||<0.001
91601363|NCT01337973|183094584|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.45||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||||>0.05
91785705|NCT00835211|183452270|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|96.5||||||90.0|87.7|106.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.1|87.7|
91785706|NCT02343549|183452271|SUPERIORITY||12-Month Survival Rate|0.333||||0.537|TWO_SIDED|95.0|0.075|0.701||This p-value is only based on partial enrollment of Stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|Assuming the true 12-month survival rate is 0.30 under the null hypothesis, then this design will provide 90% power to detect a difference of 0.20 under the alternative hypothesis, assuming a one-sided alpha = 0.10 significance level. A Simon optimal 2-stage design with Stage 1 n=22 and a total of n=46 subjects was determined with the following rejection regions: For n = 22, the rejection region in number of subjects alive at 12 months is 0 - 7, and for n = 46 it is 8 - 17.||0.701|0.075|0.537
91785707|NCT02343549|183452272|OTHER|Estimation Only|Median|9.9|||||TWO_SIDED|95.0|4.8|12.8|||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||12.8|4.8|
91785708|NCT02343549|183452273|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median PFS (in months). The Greenwood method was used to estimate confidence limits of median progression free survival.|||10.4|4.8|
91785709|NCT02343549|183452274|OTHER|Estimation only|Response Rate|0.333|||||TWO_SIDED|95.0|0.075|0.701|||||Confidence interval estimated using the Clopper Pearson method.|||0.701|0.075|
91601364|NCT01337973|183094584|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.5||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||||>0.05
91601365|NCT01337973|183094584|SUPERIORITY||||||<|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.58||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||||<0.05
91601366|NCT00408694|183094613|OTHER|||||||||||||||||Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.|If 3 of the first 14 patients or 4 of the first 42 patients experience the specified adverse events, then the regimen is considered unacceptable as calculated by the Fleming method for a two-stage design with type I error and the statistical power were set at 0.14 and 0.83, respectively.|||
91601367|NCT01700192|183094622|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Wilcoxon (Mann-Whitney)|||||-0.40|-1.20|<0.001
91601368|NCT01700192|183094622|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-17.2|||||TWO_SIDED|95.0|-25.0|-9.7||||||||-9.7|-25.0|
91601369|NCT01700192|183094625|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Wilcoxon (Mann-Whitney)|||||-0.30|-1.00|<0.001
91601370|NCT01700192|183094625|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-15.5|||||TWO_SIDED|95.0|-24.4|-7.3||||||||-7.3|-24.4|
91601371|NCT01700192|183094626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.154|TWO_SIDED|95.0|-0.35|0.05|||Zero-inflated Log-normal Model|||||0.05|-0.35|0.154
91601372|NCT01700192|183094626|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-18.4|||||TWO_SIDED|95.0|-41.0|4.3||||||||4.3|-41|
91601373|NCT01700192|183094627|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6|||Wilcoxon (Mann-Whitney)|||||-0.60|-1.70|<0.001
91601374|NCT01700192|183094627|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.7|||||TWO_SIDED|95.0|-24.6|-4.0||||||||-4.0|-24.6|
91650281|NCT00294723|183193065|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-17.79||||0.0003||95.0|-27.48|-8.09||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-8.09|-27.48|0.0003
91650282|NCT00294723|183193065|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-11.33||||0.0217||95.0|-20.99|-1.66||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.66|-20.99|0.0217
91650283|NCT00294723|183193065|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg|Estimated treatment difference, LS Mean|-6.46||||0.1942||95.0|-16.23|3.3||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.30|-16.23|0.1942
91650284|NCT00294723|183193066|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-16.63||||0.0007||95.0|-26.19|-7.06||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-7.06|-26.19|0.0007
91601375|NCT01700192|183094628|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Wilcoxon (Mann-Whitney)|||||-3.10|-9.10|<0.001
91601376|NCT01700192|183094628|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.0|||||TWO_SIDED|95.0|-22.7|-8.3||||||||-8.3|-22.7|
91601377|NCT01017952|183094637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.04|TWO_SIDED|95.0|0.66|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.99|0.66|0.040
91601378|NCT01017952|183094637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.024|TWO_SIDED|95.0|0.64|0.97|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.97|0.64|0.024
91601379|NCT01017952|183094637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.85|0.56|<0.001
91601380|NCT01017952|183094638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.177
91601381|NCT01017952|183094638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.036|TWO_SIDED|95.0|0.66|0.99|||Regression, Cox|||||0.99|0.66|0.036
91709441|NCT04633291|183311486|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.08|12.87||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||12.87|0.08|1.0
91785710|NCT02343549|183452275|OTHER|Estimation only|Disease Control Rate|1.0|||||TWO_SIDED|95.0|0.664|1.0||||||||1.000|0.664|
91785711|NCT02343549|183452276|OTHER|Estimation only.|Median|8.1|||||TWO_SIDED|95.0|3.7|8.6|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||8.6|3.7|
91785712|NCT02343549|183452277|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median duration of disease control.|||10.4|4.8|
91601382|NCT01017952|183094638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||Regression, Cox|||||0.82|0.54|<0.001
91601383|NCT01017952|183094639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.154|TWO_SIDED|95.0|0.65|1.07|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.07|0.65|0.154
91601384|NCT01017952|183094639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.041|TWO_SIDED|95.0|0.6|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.99|0.60|0.041
91601385|NCT01017952|183094639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.84|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.84|0.51|<0.001
91601386|NCT01017952|183094640|SUPERIORITY_OR_OTHER||Least squares mean difference|0.034||||0.034|TWO_SIDED|95.0|0.003|0.066||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.066|0.003|0.034
91601387|NCT01017952|183094640|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.143|TWO_SIDED|95.0|-0.008|0.056|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.056|-0.008|0.143
91785713|NCT04343235|183452310|SUPERIORITY|||||||0.21|||||||Fisher Exact|||||||0.21
91785714|NCT04343235|183452311|SUPERIORITY|||||||0.7||||||Main effect for Randomization group|ANOVA|||||||0.70
91601388|NCT01017952|183094640|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026||||0.115|TWO_SIDED|95.0|-0.006|0.057|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.057|-0.006|0.115
91601389|NCT02979431|183094654|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
91601390|NCT02979431|183094654|SUPERIORITY||||||=|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||=0.001
91601391|NCT02979431|183094654|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
91601392|NCT02979431|183094655|SUPERIORITY||Mean Difference (Net)|-0.6452|STANDARD_ERROR_OF_MEAN|0.5843|=|0.271|TWO_SIDED||||||Mixed Models Analysis|||A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.||||=0.271
91601393|NCT02979431|183094655|SUPERIORITY||Difference in LS means|-0.4904|STANDARD_ERROR_OF_MEAN|0.5862|=|0.404|TWO_SIDED||||||Mixed Models Analysis|||||||=0.404
91601394|NCT02979431|183094655|SUPERIORITY||Difference in LS means|-0.2156|STANDARD_ERROR_OF_MEAN|0.5842|=|0.713|TWO_SIDED||||||Mixed Models Analysis|||||||=0.713
91601395|NCT01405053|183094679|SUPERIORITY||LS Mean difference|2.601|STANDARD_ERROR_OF_MEAN|6.558||0.6928|TWO_SIDED|95.0|-10.5|15.7|||ANCOVA|||The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.||15.7|-10.5|0.6928
91601396|NCT02642094|183094703|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.0020
91601397|NCT02642094|183094704|SUPERIORITY|||||||0.0137|||||||t-test, 2 sided|||||||0.0137
91601398|NCT02642094|183094705|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91785715|NCT04343235|183452312|SUPERIORITY|||||||0.77|||||||ANOVA|Main effect for randomization group||||||0.77
91785716|NCT04343235|183452313|SUPERIORITY|||||||0.54|||||||ANOVA|Main effect for randomization group||||||0.54
91601399|NCT02642094|183094706|SUPERIORITY|||||||0.0072|||||||t-test, 2 sided|||||||0.0072
91601400|NCT02642094|183094707|SUPERIORITY|||||||0.3093|||||||t-test, 2 sided|||||||0.3093
91601401|NCT00993928|183094715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q3: Percent change in sleep latency from baseline to week 7.||||0.85
91785717|NCT04343235|183452314|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.0||0.47|TWO_SIDED|95.0|-1.5|3.1|||t-test, 2 sided|||||3.1|-1.5|0.47
91785718|NCT04343235|183452315|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
91785719|NCT04343235|183452316|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91785720|NCT01763996|183452322|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.756|TWO_SIDED|95.0|-10.1|13.76||0.05 level of significance|ANOVA|Analysis of variance (ANOVA) model that includes sequence, period, and treatment as fixed factors and subjects within sequence as a random factor.||||13.76|-10.10|0.756
91785721|NCT00776919|183452333|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91785722|NCT00776919|183452333|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Cochran-Mantel-Haenszel|||||||0.016
91601402|NCT00993928|183094715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.||||0.86
91601403|NCT00993928|183094717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Chi-squared|||||||0.42
91601404|NCT00993928|183094719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||t-test, 2 sided|||Compare percent change from baseline to week 7 Distress Thermometer score.||||0.64
91601405|NCT03550066|183094743|NON_INFERIORITY|The non-inferiority limit, d, is selected as the largest difference that is clinically acceptable. Here the non-inferiority limit is d=.6 (a medium to large effect size).||||||0.18||||||Threshold for statistical significance: \<.05|t-test, 2 sided|||||||0.18
91601406|NCT00695565|183094803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.168|TWO_SIDED|95.0|||||Mixed Models Analysis|||This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).||||0.168
91650285|NCT00294723|183193066|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.02||||0.0395||95.0|-19.56|-0.49||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-0.49|-19.56|0.0395
91601407|NCT00695565|183094803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|||||Mixed Models Analysis|||"Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.~This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2."||||0.014
91601408|NCT02321436|183094883|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified log rank test.||||||0.0176||||||Significance level (α) = 5%|Log Rank|||||||0.0176
91601409|NCT02321436|183094883|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified Wilcoxon test.||||||0.048||||||Significance level (α) = 5%|Wilcoxon (Mann-Whitney)|||||||0.0480
91601410|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.0||||0.0005|TWO_SIDED|95.0|-1.54|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||-0.47|-1.54|0.0005
91601411|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0007|TWO_SIDED|95.0|-1.63|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||-0.47|-1.63|0.0007
91709442|NCT01483599|183311503|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (\<=) 90 kilogram (kg), greater than (\>) 90 kg).||||0.002
91522733|NCT00261495|182920722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.171||95.0|-0.14|0.81||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.81|-0.14|0.171
91522734|NCT00261495|182920723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.475||95.0|-0.31|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.31|0.475
91785723|NCT00776919|183452333|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91785724|NCT00776919|183452334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
91785725|NCT00776919|183452334|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.015
91785726|NCT00776919|183452334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
91785727|NCT00776919|183452335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
91785728|NCT00776919|183452335|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.102
91785729|NCT00776919|183452335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
91785730|NCT00776919|183452336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
91785731|NCT00776919|183452336|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.032
91601412|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0006|TWO_SIDED|95.0|-1.62|-0.48||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||-0.48|-1.62|0.0006
91785732|NCT00776919|183452336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
91785733|NCT02093819|183452348|SUPERIORITY_OR_OTHER||Slope|1.1313|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|1.0249|1.2376|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.2376|1.0249|
91785734|NCT02093819|183452348|SUPERIORITY_OR_OTHER||Slope|0.9568|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|90.0|0.783|1.1307|||||Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1307|0.7830|
91522735|NCT00261495|182920724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.359||95.0|-0.26|0.72||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.72|-0.26|0.359
91601413|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.84||||0.0027|TWO_SIDED|95.0|-1.36|-0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||-0.31|-1.36|0.0027
91601414|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.83||||0.0052|TWO_SIDED|95.0|-1.39|-0.26||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||-0.26|-1.39|0.0052
91601415|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.52||||0.2037|TWO_SIDED|95.0|-1.35|0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||0.31|-1.35|0.2037
91601416|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.15||||0.7656|TWO_SIDED|95.0|-1.25|0.94||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||0.94|-1.25|0.7656
91650286|NCT00294723|183193066|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1789||95.0|-16.24|3.03||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.03|-16.24|0.1789
91650287|NCT00294723|183193067|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.9||||0.0038||95.0|-21.6|-4.2||2-sided significance level 5%|ANCOVA|||Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-4.2|-21.6|0.0038
91785735|NCT02093819|183452349|SUPERIORITY_OR_OTHER||Slope|1.0732|STANDARD_ERROR_OF_MEAN|0.0468|||TWO_SIDED|90.0|0.9946|1.1518|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1518|0.9946|
91785736|NCT02093819|183452349|SUPERIORITY_OR_OTHER||Slope|0.9603|STANDARD_ERROR_OF_MEAN|0.0838|||TWO_SIDED|90.0|0.8174|1.1032|||||Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1032|0.8174|
91785737|NCT02428478|183452360|OTHER|||||||0.01||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Tonic analysis||||0.01
91785738|NCT02428478|183452360|OTHER|||||||0.38||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Phasic analysis||||0.38
91785739|NCT02428478|183452361|OTHER||Median Change|-0.6||||0.037|TWO_SIDED||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.037
91601417|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.12||||0.8521|TWO_SIDED|95.0|-1.46|1.23||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||1.23|-1.46|0.8521
91601418|NCT02321436|183094884|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.21||||0.6582|TWO_SIDED|95.0|-1.24|0.81||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||0.81|-1.24|0.6582
91601419|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|0.8||||0.8754|TWO_SIDED|95.0|-9.5|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||11.1|-9.5|0.8754
91601420|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.9||||0.8805|TWO_SIDED|95.0|-12.8|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||11.1|-12.8|0.8805
91601421|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-2.2||||0.6992|TWO_SIDED|95.0|-14.0|9.6||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||9.6|-14.0|0.6992
91601422|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.1||||0.9882|TWO_SIDED|95.0|-13.0|12.8||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||12.8|-13.0|0.9882
91601423|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|4.6||||0.5646|TWO_SIDED|95.0|-11.9|21.2||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||21.2|-11.9|0.5646
91601424|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-12.5||||0.2325|TWO_SIDED|95.0|-34.0|9.0||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||9.0|-34.0|0.2325
91709443|NCT01483599|183311503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785740|NCT02428478|183452361|OTHER||||||>|0.5|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||>0.5
91601425|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-14.1||||0.2441|TWO_SIDED|95.0|-39.4|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||11.1|-39.4|0.2441
91601426|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-9.0||||0.4311|TWO_SIDED|95.0|-33.7|15.7||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||15.7|-33.7|0.4311
91601427|NCT02321436|183094885|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-4.5||||0.731|TWO_SIDED|95.0|-33.3|24.3||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||24.3|-33.3|0.7310
91601428|NCT02321436|183094886|OTHER|||||||0.6128||||||The Cochran-Mantel-Haenszel (CMH) p-value represents the strength of the association between treatment and global assessments of changes at the last visit, adjusted for symptomatic status at baseline.|Cochran-Mantel-Haenszel|p value significance level = 5%||||||0.6128
91601429|NCT00644787|183094890|NON_INFERIORITY_OR_EQUIVALENCE|Difference of 7.5 mm in VAS score was selected as the threshold value for clinical non-inferiority of Fentanyl 1-day transdermal patch to Fentanyl 3-day transdermal patch.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.23||||||||6.23|-3.50|
91601430|NCT00546052|183094905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.74||0.999||95.0|-0.02|0.06|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.||0.06|-0.02|0.999
91601431|NCT00546052|183094906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.62||0.999||95.0|0.01|0.07|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.||0.07|0.01|0.999
91709444|NCT01483599|183311503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91650288|NCT00294723|183193067|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-6.3||||0.1616||95.0|-15.0|2.5||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.5|-15.0|0.1616
91785741|NCT00884741|183452362|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.11|TWO_SIDED|95.0|0.93|1.37||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||1.37|0.93|0.11
91601432|NCT00546052|183094908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.95|STANDARD_DEVIATION|13.34|<|0.001||95.0|-17.62|-16.27|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg||-16.27|-17.62|<0.001
91601433|NCT00546052|183094909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.84|STANDARD_DEVIATION|8.39|<|0.001||95.0|-10.29|-9.39|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.||-9.39|-10.29|<0.001
91601434|NCT00546052|183094910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|5.4|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
91601435|NCT00546052|183094911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_DEVIATION|5.2|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
91601436|NCT00546052|183094912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.5|STANDARD_DEVIATION|32.1||0.084|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.084
91601437|NCT00546052|183094913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|18.0||0.654|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.654
91601438|NCT00546052|183094914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|43.5||0.336|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.336
91601439|NCT00546052|183094915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|17.0||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
91601440|NCT00546052|183094916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.2|STANDARD_DEVIATION|63.8||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
91601441|NCT00546052|183094917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|8.7||0.613|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.613
91601442|NCT01680900|183094918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.05|TWO_SIDED|95.0|-2.6|-0.48|||Regression, Linear|||||-0.48|-2.60|0.05
91601443|NCT01680900|183094919|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91601444|NCT01680900|183094920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.05|TWO_SIDED|95.0|-0.75|-0.08|||Regression, Linear|||||-0.08|-0.75|<0.05
91601445|NCT01680900|183094924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.05|TWO_SIDED|95.0|-0.74|-0.21|||Regression, Linear|||||-0.21|-0.74|0.05
91601446|NCT03048422|183094925|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|2.0|10.7||||||Difference in proportions for intention-to-treat analysis.||10.7|2.0|
91601447|NCT03048422|183094925|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|1.6|10.3||||||Difference in proportions for per-protocol analysis.||10.3|1.6|
91601448|NCT03048422|183094925|SUPERIORITY||Risk Difference (RD)|6.5||||0.005|TWO_SIDED|95.0|2.0|10.7|||Wald test of two proportions|||Difference in proportions for superiority and intention-to-treat analysis.||10.7|2.0|0.005
91601449|NCT03048422|183094926|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
91601450|NCT03048422|183094926|SUPERIORITY||Risk Difference (RD)|0.2||||0.97|TWO_SIDED|95.0|-8.8|9.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||9.1|-8.8|0.97
91601451|NCT03048422|183094926|SUPERIORITY||Risk Difference (RD)|-8.6||||0.047|TWO_SIDED|95.0|-17.1|-0.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.1|-17.1|0.047
91601452|NCT03048422|183094927|SUPERIORITY||Risk Difference (RD)|-5.6||||0.098|TWO_SIDED|95.0|-14.2|2.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.9|-14.2|0.098
91785742|NCT00884741|183452363|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.79||||0.004|TWO_SIDED|95.0|0.66|0.94||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||0.94|0.66|0.004
91785743|NCT00884741|183452364|SUPERIORITY_OR_OTHER|||||||0.42||||||Two-sided|Chi-squared|||||||0.42
91601453|NCT03048422|183094927|SUPERIORITY||Risk Difference (RD)|2.6||||0.26|TWO_SIDED|95.0|-5.9|11.7|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF-EFV/FTC/TDF).||11.7|-5.9|0.26
91601454|NCT03048422|183094927|SUPERIORITY||Risk Difference (RD)|-2.8||||0.26|TWO_SIDED|95.0|-11.3|5.8|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF-EFV/FTC/TDF).||5.8|-11.3|0.26
91601455|NCT03048422|183094928|SUPERIORITY||Risk Difference (RD)|-3.2||||0.25|TWO_SIDED|95.0|-12.8|6.3|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.||6.3|-12.8|0.25
91522736|NCT00261495|182920725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.611||95.0|-0.52|0.3||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.30|-0.52|0.611
91601456|NCT03048422|183094928|SUPERIORITY||Risk Difference (RD)|-2.3||||0.32|TWO_SIDED|95.0|-12.1|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||7.5|-12.1|0.32
91601457|NCT03048422|183094928|SUPERIORITY||Risk Difference (RD)|-5.5||||0.11|TWO_SIDED|95.0|-14.3|3.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||3.2|-14.3|0.11
91601458|NCT03048422|183094929|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.0001|TWO_SIDED|95.0|9.3|22.0|||Wald test of two proportions|||Difference in proportions between arms for intention-to-treat analysis with null hypothesis of no difference (DTG groups - EFV/FTC/TDF).||22.0|9.3|< 0.0001
91650289|NCT00294723|183193067|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1319||95.0|-15.3|2.0||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.0|-15.3|0.1319
91601459|NCT03048422|183094930|SUPERIORITY||Risk Difference (RD)|-0.1||||0.97|TWO_SIDED|95.0|-3.3|3.2|||Wald test of two proportions|||Difference in proportions for intention-to-treat analysis with null hypothesis of no difference between arms (DTG arms - EFV/FTC/TDF).||3.2|-3.3|0.97
91601460|NCT03048422|183094931|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.001|TWO_SIDED|95.0|1.9|3.1|||Kaplan-Meier|||||3.1|1.9|< 0.001
91601461|NCT03048422|183094932|SUPERIORITY||Risk Difference (RD)|3.6||||0.19|TWO_SIDED|95.0|-1.8|9.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||9.1|-1.8|0.19
91601462|NCT03048422|183094932|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-17.9|-5.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||-5.2|-17.9|< 0.001
91709445|NCT01483599|183311503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785744|NCT02969655|183452369|NON_INFERIORITY|Non-inferiority was established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to \<0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.|Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.11|0.23||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.|||0.23|-0.11|<.0001
91522737|NCT00261495|182920726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.526||95.0|-0.6|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.60|0.526
91601463|NCT03048422|183094932|SUPERIORITY||Risk Difference (RD)|-7.9||||0.022|TWO_SIDED|95.0|-14.6|-1.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||-1.2|-14.6|0.022
91601464|NCT03048422|183094933|SUPERIORITY||Risk Difference (RD)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||10.1|-5.9|0.61
91601465|NCT03048422|183094933|SUPERIORITY||Risk Difference (RD)|-1.4||||0.74|TWO_SIDED|95.0|-9.4|6.6|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||6.6|-9.4|0.74
91709446|NCT01483599|183311503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785745|NCT02969655|183452370|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7442|TWO_SIDED|95.0|0.34|1.71||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.|||1.71|0.34|0.7442
91601466|NCT03048422|183094933|SUPERIORITY||Risk Difference (RD)|0.7||||0.86|TWO_SIDED|95.0|-7.4|8.8|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||8.8|-7.4|0.86
91785746|NCT01578850|183452393|SUPERIORITY_OR_OTHER||Difference in Proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).|Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.|||35.81|16.78|<0.001
91601467|NCT03048422|183094934|SUPERIORITY||Risk Difference (RD)|4.3||||0.27|TWO_SIDED|95.0|-3.4|11.9|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG groups - EFV/FTC/TDF).||11.9|-3.4|0.27
91601468|NCT03048422|183094935|SUPERIORITY||Risk Difference (RD)|-0.1||||0.49|TWO_SIDED|95.0|-7.6|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference combined DTG arms-EFV/FTC/TDF.||7.5|-7.6|0.49
91601469|NCT03048422|183094936|SUPERIORITY||Risk Difference (RD)|4.1||||0.15|TWO_SIDED|95.0|-3.8|12.0|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of combined DTG arms - EFV/FTC/TDF.||12.0|-3.8|0.15
91601470|NCT03048422|183094937|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
91601471|NCT03048422|183094937|SUPERIORITY||Risk Difference (RD)|-0.3||||0.95|TWO_SIDED|95.0|-9.3|8.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||8.6|-9.3|0.95
91601472|NCT03048422|183094937|SUPERIORITY||Risk Difference (RD)|-9.1||||0.037|TWO_SIDED|95.0|-17.6|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.6|-17.6|0.037
91601473|NCT03048422|183094938|SUPERIORITY||Odds Ratio (OR)|0.73||||0.095|TWO_SIDED|95.0|0.5|1.06|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.06|0.50|0.095
91601474|NCT03048422|183094938|SUPERIORITY||Odds Ratio (OR)|0.83||||0.3|TWO_SIDED|95.0|0.58|1.19|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TDF - EFV/FTC/TDF).||1.19|0.58|0.30
91709447|NCT01483599|183311503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91601475|NCT03048422|183094938|SUPERIORITY||Odds Ratio (OR)|0.6||||0.008|TWO_SIDED|95.0|0.42|0.88|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - EFV/FTC/TDF).||0.88|0.42|0.008
91601476|NCT03048422|183094939|SUPERIORITY||Risk Difference (RD)|0.5||||0.28|TWO_SIDED|95.0|-1.2|2.1|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.1|-1.2|0.28
91601477|NCT03048422|183094939|SUPERIORITY||Risk Difference (RD)|-0.1||||0.47|TWO_SIDED|95.0|-1.5|1.4|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||1.4|-1.5|0.47
91785747|NCT01578850|183452394|SUPERIORITY_OR_OTHER||Difference in proportions|23.7||||0.019|TWO_SIDED|95.0|6.83|40.61|||Cochran-Mantel-Haenszel|The p-value from CMH test of general association was stratified by geographic region.||||40.61|6.83|0.019
91601478|NCT03048422|183094939|SUPERIORITY||Risk Difference (RD)|0.4||||0.31|TWO_SIDED|95.0|-1.3|2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||2.2|-1.3|0.31
91601479|NCT03048422|183094940|SUPERIORITY|The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.|Risk Difference (RD)|-1.0||||0.2|TWO_SIDED|95.0|-3.4|1.3|||Z-test|||||1.3|-3.4|0.20
91601480|NCT03048422|183094940|SUPERIORITY||Risk Difference (RD)|-4.9||||0.008|TWO_SIDED|95.0|-8.9|-0.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||-0.9|-8.9|0.008
91601481|NCT03048422|183094940|SUPERIORITY||Risk Difference (RD)|-5.9|||<|0.001|TWO_SIDED|95.0|-9.7|-2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||-2.2|-9.7|<0.001
91601482|NCT03048422|183094941|SUPERIORITY||Mean Difference (Final Values)|-0.093||||0.12|TWO_SIDED|95.0|-0.208|0.023|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - DTG+FTC/TDF).||0.023|-0.208|0.12
91709448|NCT01483599|183311504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785748|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|-0.6||||0.371|TWO_SIDED|95.0|-1.76|0.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Baseline||0.57|-1.76|0.371
91785749|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Baseline||1.81|-0.59|0.358
91601483|NCT03048422|183094941|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.39|TWO_SIDED|95.0|-0.061|0.158|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TDF - EFV/FTC/TDF).||0.158|-0.061|0.39
91601484|NCT03048422|183094941|SUPERIORITY||Mean Difference (Final Values)|-0.045||||0.45|TWO_SIDED|95.0|-0.161|0.072|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - EFV/FTC/TDF).||0.072|-0.161|0.45
91601485|NCT03048422|183094942|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.94|TWO_SIDED|95.0|-11.3|10.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - DTG+FTC/TDF).||10.5|-11.3|0.94
91601486|NCT03048422|183094942|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.44|TWO_SIDED|95.0|-6.5|14.9|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TDF - EFV/FTC/TDF).||14.9|-6.5|0.44
91601487|NCT03048422|183094942|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.18|TWO_SIDED|95.0|-1.8|9.3|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - EFV/FTC/TDF).||9.3|-1.8|0.18
91601488|NCT03048422|183094942|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.27|TWO_SIDED|95.0|-8.9|31.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - DTG+FTC/TDF).||31.1|-8.9|0.27
91601489|NCT03048422|183094942|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.048|TWO_SIDED|95.0|-22.6|-0.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TDF - EFV/FTC/TDF).||-0.1|-22.6|0.048
91601490|NCT03048422|183094942|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|95.0|-21.0|20.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - EFV/FTC/TDF).||20.5|-21.0|0.98
91601491|NCT03048422|183094943|SUPERIORITY||Risk Difference (RD)|-0.9||||0.4|TWO_SIDED|95.0|-3.1|1.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.3|-3.1|0.40
91601492|NCT03048422|183094943|SUPERIORITY||Risk Difference (RD)|-4.3||||0.023|TWO_SIDED|95.0|-8.0|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||-0.6|-8.0|0.023
91601493|NCT03048422|183094943|SUPERIORITY||Risk Difference (RD)|-5.2||||0.003|TWO_SIDED|95.0|-8.7|-1.8|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-1.8|-8.7|0.003
91601494|NCT03048422|183094945|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-3.6||||0.16|TWO_SIDED|95.0|-8.8|1.5|||Wald test of two proportions|||||1.5|-8.8|0.16
91650290|NCT00294723|183193068|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.3||||0.0105||95.0|-21.71|-2.89||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-2.89|-21.71|0.0105
91785750|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|2.6||||0.667|TWO_SIDED|95.0|-4.76|9.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||9.98|-4.76|0.667
91785751|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||32.02|10.99|0.001
91601495|NCT03048422|183094945|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-2.7||||0.38|TWO_SIDED|95.0|-8.7|3.3|||Wald test of two proportions|||||3.3|-8.7|0.38
91601496|NCT03048422|183094945|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.3||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||Wald test of two proportions|||||-0.9|-11.8|0.023
91601497|NCT03048422|183094946|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-13.9|1.5|||Wald test of two proportions|||||1.5|-13.9|0.12
91601498|NCT03048422|183094946|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|2.0||||0.63|TWO_SIDED|95.0|-6.0|10.0|||Wald test of two proportions|||||10.0|-6.0|0.63
91601499|NCT03048422|183094946|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-4.2||||0.28|TWO_SIDED|95.0|-11.7|3.4|||Wald test of two proportions|||||3.4|-11.7|0.28
91601500|NCT03048422|183094947|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.011|TWO_SIDED|95.0|0.013|0.103|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.103|0.013|0.011
91601501|NCT03048422|183094947|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.19|TWO_SIDED|95.0|-0.014|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.070|-0.014|0.19
91601502|NCT03048422|183094947|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.04|0.133|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.133|0.040|< 0.001
91601503|NCT03048422|183094948|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.11|TWO_SIDED|95.0|-0.005|0.048|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.048|-0.005|0.11
91785752|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.004|TWO_SIDED|95.0|8.81|29.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||29.10|8.81|0.004
91522738|NCT00261495|182920727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.769||95.0|-0.49|0.36||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.36|-0.49|0.769
91601504|NCT03048422|183094948|SUPERIORITY||Mean Difference (Final Values)|0.024||||0.055|TWO_SIDED|95.0|0.0|0.049|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.049|-0.000|0.055
91601505|NCT03048422|183094948|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.001|TWO_SIDED|95.0|0.022|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.070|0.022|< 0.001
91601506|NCT03048422|183094949|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.041|TWO_SIDED|95.0|0.001|0.045|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.045|0.001|0.041
91601507|NCT03048422|183094949|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.002|TWO_SIDED|95.0|0.013|0.055|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.055|0.013|0.002
91601508|NCT03048422|183094949|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.036|0.078|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.078|0.036|< 0.001
91601509|NCT04247425|183094969|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.59
91650291|NCT00294723|183193068|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.49||||0.606||95.0|-11.95|6.98||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||6.98|-11.95|0.6060
91709449|NCT01483599|183311504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785753|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.79|40.83|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||40.83|20.79|<0.001
91785754|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.89|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||37.54|16.89|<0.001
91785755|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.51|41.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||41.08|21.51|<0.001
91785756|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|30.2|||<|0.001|TWO_SIDED|95.0|19.95|40.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.47|19.95|<0.001
91785757|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||35.81|16.78|<0.001
91601510|NCT04247425|183094970|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.02
91601511|NCT04247425|183094971|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||1.0
91601512|NCT04247425|183094972|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.09
91601513|NCT00762515|183094998|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline is used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
91601514|NCT00762515|183094999|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline to be used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
91601515|NCT00692211|183095000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.01|TWO_SIDED|95.0|1.04|2.32||Not adjusted for multiple comparisons, a priori threshold of 0.05|Regression, Logistic|||Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.||2.32|1.04|0.01
91785758|NCT01578850|183452396|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.67|37.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||37.47|16.67|<0.001
91785759|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|1.3||||0.774|TWO_SIDED|95.0|-9.03|11.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||11.68|-9.03|0.774
91785760|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.034|TWO_SIDED|95.0|2.86|21.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||21.69|2.86|0.034
91785761|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|16.9||||0.02|TWO_SIDED|95.0|6.33|27.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||27.54|6.33|0.020
91601516|NCT02851173|183095001|OTHER|||||||0.79|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group.||||0.79
91601517|NCT02851173|183095001|OTHER|||||||0.87|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. MCI group.||||0.87
91709450|NCT01483599|183311504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785762|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|14.6||||0.007|TWO_SIDED|95.0|5.48|23.8|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||23.80|5.48|0.007
91601518|NCT02851173|183095001|OTHER|||||||0.16|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group. 3 outliers removed, whose scores were outside 1.5 times the interquartile range.||||0.16
91601519|NCT02851173|183095002|OTHER|||||||0.22|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 1.||||0.22
91601520|NCT02851173|183095002|OTHER|||||||0.69|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left medial frontal/superior frontal gyrus.||||0.69
91601521|NCT02851173|183095002|OTHER|||||||0.25|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior parietal lobule.||||0.25
91601522|NCT02851173|183095002|OTHER|||||||0.86|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left inferior parietal lobule.||||0.86
91601523|NCT02851173|183095002|OTHER|||||||0.28|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 2.||||0.28
91601524|NCT02851173|183095002|OTHER|||||||0.12|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior frontal gyrus.||||0.12
91601525|NCT02851173|183095002|OTHER|||||||0.26|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right middle frontal gyrus.||||0.26
91709451|NCT01483599|183311504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91522739|NCT00261495|182920728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.843||95.0|-0.4|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.40|0.843
91601526|NCT02851173|183095002|OTHER|||||||0.83|||||||ANOVA|||The contract of interest was the Time x Treatment Group interaction. Right inferior frontal gyrus.||||0.83
91601527|NCT02851173|183095002|OTHER|||||||0.55|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 1.||||0.55
91785763|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|24.9|||<|0.001|TWO_SIDED|95.0|14.72|34.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||34.98|14.72|<0.001
91785764|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|18.8|||<|0.001|TWO_SIDED|95.0|10.16|27.38|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||27.38|10.16|<0.001
91785765|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|30.9|||<|0.001|TWO_SIDED|95.0|21.03|40.76|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.76|21.03|<0.001
91601528|NCT02851173|183095002|OTHER|||||||0.76|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left medial frontal/superior frontal gyrus.||||0.76
91601529|NCT02851173|183095002|OTHER|||||||0.38|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior parietal lobule.||||0.38
91601530|NCT02851173|183095002|OTHER|||||||0.93|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left inferior parietal lobule.||||0.93
91601531|NCT02851173|183095002|OTHER|||||||0.41|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 2.||||0.41
91601532|NCT02851173|183095002|OTHER|||||||0.06|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior frontal gyrus.||||0.06
91601533|NCT02851173|183095002|OTHER|||||||0.18|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right middle frontal gyrus.||||0.18
91601534|NCT02851173|183095002|OTHER|||||||0.84|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right inferior frontal gyrus.||||0.84
91601535|NCT02851173|183095003|OTHER|||||||0.53|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.53
91601536|NCT02851173|183095003|OTHER|||||||0.74|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.74
91709452|NCT01483599|183311504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91601537|NCT02851173|183095004|OTHER|||||||0.72|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.72
91601538|NCT02851173|183095004|OTHER|||||||0.97|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.97
91785766|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|20.6|||<|0.001|TWO_SIDED|95.0|11.78|29.52|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||29.52|11.78|<0.001
91601539|NCT05900115|183095036|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.77|TWO_SIDED||||||Regression, Linear|||||||0.77
91601540|NCT05900115|183095037|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
91601541|NCT05900115|183095038|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.13|STANDARD_ERROR_OF_MEAN|0.12||0.28|TWO_SIDED||||||Regression, Linear|||||||0.28
91601542|NCT05900115|183095039|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
91601543|NCT05900115|183095040|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.01|TWO_SIDED||||||Regression, Linear|||||||0.01
91650292|NCT00294723|183193068|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.81||||0.0392||95.0|-19.14|-0.49||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-0.49|-19.14|0.0392
91650293|NCT00294723|183193069|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.98||||0.0227||95.0|-20.42|-1.54||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-1.54|-20.42|0.0227
91650294|NCT00294723|183193069|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-1.83||||0.7047||95.0|-11.33|7.66||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||7.66|-11.33|0.7047
91650295|NCT00294723|183193069|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.15||||0.0553||95.0|-18.51|0.21||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||0.21|-18.51|0.0553
91785767|NCT01578850|183452398|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|17.38|36.93|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||36.93|17.38|<0.001
91785768|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.2|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||-0.20|-0.73|<0.001
91601544|NCT05900115|183095041|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.18|TWO_SIDED||||||Regression, Linear|||||||0.18
91601545|NCT05900115|183095042|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
91601546|NCT05900115|183095043|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED||||||Regression, Linear|||||||0.56
91522740|NCT00261495|182920729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.977||95.0|-0.45|0.44||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.44|-0.45|0.977
91601547|NCT05900115|183095044|EQUIVALENCE|To examine intervention effects on primary dichotomous outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Odds Ratio (OR)|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.85|TWO_SIDED|95.0|0.38|3.2|||Regression, Logistic|||||3.20|.38|0.85
91601548|NCT05900115|183095045|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.05||1|TWO_SIDED||||||Regression, Linear|||||||1.00
91601549|NCT01641120|183095060|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||<.05
91601550|NCT01641120|183095061|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.193
91601551|NCT01641120|183095062|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.035
91601552|NCT01641120|183095063|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||.005
91601553|NCT02324270|183095064|EQUIVALENCE|If the 90% CI for the ratio of mean changes between test and reference products was contained within the interval, \[0.80,1.25\], then the products were considered to be equivalent.|Ratio|1.01|||||TWO_SIDED|90.0|0.94|1.08||||||||1.08|0.94|
91601554|NCT02324270|183095065|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
91601555|NCT02324270|183095065|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91785769|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.006|TWO_SIDED|95.0|-0.61|-0.11|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||-0.11|-0.61|0.006
91785770|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||-0.39|-0.96|<0.001
91601556|NCT03521791|183095066|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.133|||||||Chi-squared, Corrected|||||||0.133
91601557|NCT03521791|183095067|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
91601558|NCT03521791|183095068|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.333|||||||Chi-squared, Corrected|||||||0.333
91601559|NCT03521791|183095069|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
91601560|NCT03521791|183095070|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.394|||||||Fisher Exact|||||||0.394
91601561|NCT03521791|183095071|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.056|||||||t-test, 2 sided|||||||0.056
91601562|NCT03521791|183095073|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.114|||||||Fisher Exact|||||||0.114
91601563|NCT03521791|183095074|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.117|||||||Chi-squared, Corrected|||||||0.117
91601564|NCT03521791|183095075|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.626|||||||Fisher Exact|||||||0.626
91785771|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||-0.28|-0.82|<0.001
91785772|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.03|-0.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||-0.46|-1.03|<0.001
91785773|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.92|-0.37|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||-0.37|-0.92|<0.001
91785774|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.98|-0.4|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||-0.40|-0.98|<0.001
91785775|NCT01578850|183452400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.91|-0.36|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||-0.36|-0.91|<0.001
91785776|NCT01578850|183452401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
91785777|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|1.4||||0.961|TWO_SIDED|95.0|-6.13|8.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 24||8.90|-6.13|0.961
91785778|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 28||32.02|10.99|0.001
91601565|NCT00680836|183095076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.26|TWO_SIDED|95.0|-1.0|0.3|||t-test, 2 sided|||||0.3|-1.0|0.26
91601566|NCT00680836|183095077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|0.0|0.5|||t-test, 2 sided|||||0.5|0.0|0.98
91601567|NCT00680836|183095078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.78
91601568|NCT00680836|183095079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.64|TWO_SIDED|95.0|-0.2|0.2|||Chi-squared|||||0.2|-0.2|0.64
91522741|NCT00261495|182920730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.977||95.0|-0.47|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.47|0.977
91785779|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.007|TWO_SIDED|95.0|8.08|28.53|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 28||28.53|8.08|0.007
91522742|NCT00261495|182920731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.902||95.0|-0.51|0.45||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.45|-0.51|0.902
91522743|NCT00261495|182920733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.36||||0.169||95.0|-5.74|1.02||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.02|-5.74|0.169
91522744|NCT00261495|182920734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.245||95.0|-5.09|1.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.31|-5.09|0.245
91522745|NCT00261495|182920735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||0.071||95.0|-5.51|0.23||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.23|-5.51|0.071
91601569|NCT00680836|183095080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.72|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||||0.5|-0.7|0.72
91601570|NCT00680836|183095081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||||0.6|-0.5|0.86
91601571|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|0.993||||0.791|TWO_SIDED|95.0|0.946|1.043|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.|||1.043|0.946|0.791
91601572|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.|||1.050|0.952|>0.999
91785780|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|31.4|||<|0.001|TWO_SIDED|95.0|21.42|41.39|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 36||41.39|21.42|<0.001
91785781|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.83|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 36||37.54|16.83|<0.001
91785782|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.53|41.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 44||41.02|21.53|<0.001
91785783|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.54|41.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 44||41.05|20.54|<0.001
91785784|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.82|35.74|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 52||35.74|16.82|<0.001
91785785|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|27.0|||<|0.001|TWO_SIDED|95.0|16.63|37.44|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 52||37.44|16.63|<0.001
91785786|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0||||0.766|TWO_SIDED|95.0|-1.69|1.65|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 24||1.65|-1.69|0.766
91785787|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in Proportions|8.2||||0.091|TWO_SIDED|95.0|2.32|14.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 28||14.10|2.32|0.091
91785788|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.227|TWO_SIDED|95.0|1.28|11.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 28||11.75|1.28|0.227
91785789|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|9.9||||0.072|TWO_SIDED|95.0|3.27|16.6|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 36||16.60|3.27|0.072
91785790|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|8.8||||0.108|TWO_SIDED|95.0|2.43|15.2|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 36||15.20|2.43|0.108
91785791|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|11.7||||0.035|TWO_SIDED|95.0|4.69|18.72|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||18.72|4.69|0.035
91785792|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|10.6||||0.03|TWO_SIDED|95.0|4.2|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||17.06|4.20|0.030
91785793|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|11.1||||0.048|TWO_SIDED|95.0|4.15|18.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 52||18.06|4.15|0.048
91601573|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.001||||0.975|TWO_SIDED|95.0|0.953|1.051|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.|||1.051|0.953|0.975
91601574|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.|||1.050|0.952|>0.999
91601575|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.003||||0.908|TWO_SIDED|95.0|0.955|1.053|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.|||1.053|0.955|0.908
91785794|NCT01578850|183452403|SUPERIORITY_OR_OTHER||Difference in proportions|11.2||||0.016|TWO_SIDED|95.0|4.92|17.58|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 52||17.58|4.92|0.016
91601576|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.025||||0.312|TWO_SIDED|95.0|0.977|1.077|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.|||1.077|0.977|0.312
91601577|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.763|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.|||1.058|0.960|0.763
91601578|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.095|||<|0.001|TWO_SIDED|95.0|1.043|1.15|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.|||1.150|1.043|<0.001
91601579|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.046||||0.07|TWO_SIDED|95.0|0.996|1.098|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.|||1.098|0.996|0.070
91601580|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|0.971||||0.238|TWO_SIDED|95.0|0.925|1.02|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.|||1.020|0.925|0.238
91785795|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA Baseline||1.81|-0.59|0.358
91601581|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|0.975||||0.298|TWO_SIDED|95.0|0.928|1.023|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.|||1.023|0.928|0.298
91785796|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|3.4||||0.341|TWO_SIDED|95.0|-2.38|9.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 24||9.16|-2.38|0.341
91601582|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|0.994||||0.821|TWO_SIDED|95.0|0.947|1.044|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.|||1.044|0.947|0.821
91601583|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|0.991||||0.715|TWO_SIDED|95.0|0.944|1.04|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.|||1.040|0.944|0.715
91601584|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.759|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.|||1.058|0.960|0.759
91601585|NCT01475734|183095095|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.|||1.050|0.952|>0.999
91601586|NCT01734655|183095153|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
91785797|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.004|TWO_SIDED|95.0|8.4|28.27|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 28||28.27|8.40|0.004
91601587|NCT01734655|183095154|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
91601588|NCT01734655|183095155|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
91601589|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8127|TWO_SIDED|95.0|0.63|1.8||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||bFGF (high versus low)||1.80|0.63|0.8127
91601590|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0285|TWO_SIDED|95.0|1.06|3.08||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||E-selectin (high versus low)||3.08|1.06|0.0285
91601591|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7478|TWO_SIDED|95.0|0.64|1.85||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||ICAM (high versus low)||1.85|0.64|0.7478
91601592|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6761|TWO_SIDED|95.0|0.58|2.33||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||PlGF (high versus low)||2.33|0.58|0.6761
91601593|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4601|TWO_SIDED|95.0|0.72|2.09||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGF A (high versus low)||2.09|0.72|0.4601
91601594|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3193|TWO_SIDED|95.0|0.46|1.29||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-1 (high versus low)||1.29|0.46|0.3193
91785798|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|24.1|||<|0.001|TWO_SIDED|95.0|13.88|34.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 36||34.40|13.88|<0.001
91601595|NCT00700180|183095196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.1758|TWO_SIDED|95.0|0.85|2.45||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-2 (high versus low)||2.45|0.85|0.1758
91601596|NCT00700180|183095198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9454|TWO_SIDED|95.0|0.78|1.31|||Log Rank|||||1.31|0.78|0.9454
91601597|NCT00700180|183095199|SUPERIORITY_OR_OTHER||Difference in Responses Rates|9.34||||0.1737|TWO_SIDED|95.0|-2.4|21.0|||Cochran-Mantel-Haenszel||Approximate 95% Confidence Interval (CI) for difference of two rates using Hauck-Anderson method.|||21.0|-2.4|0.1737
91601598|NCT00700180|183095200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.6148|TWO_SIDED|95.0|-8.2|11.7|||Cochran-Mantel-Haenszel||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||11.7|-8.2|0.6148
91650296|NCT00294723|183193070|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.|Estimated treatment difference, LS Mean|-0.55|||<|0.0001||95.0|-0.77|-0.34||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.34|-0.77|<0.0001
91650297|NCT00294723|183193070|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.28||||0.0122||95.0|-0.49|-0.06||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0122
91650298|NCT00294723|183193070|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.28||||0.0123||95.0|-0.49|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0123
91709453|NCT01483599|183311504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
91785799|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.85|37.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 44||37.35|16.85|<0.001
91785800|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|24.0|||<|0.001|TWO_SIDED|95.0|13.61|34.42|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 52||34.42|13.61|<0.001
91601599|NCT00700180|183095202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.7587|TWO_SIDED|95.0|0.68|1.69|||Log Rank|||||1.69|0.68|0.7587
91601600|NCT00700180|183095204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.312|TWO_SIDED|95.0|0.87|1.53|||Log Rank|||||1.53|0.87|0.3120
91785801|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|2.3||||0.774|TWO_SIDED|95.0|-5.5|10.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 24||10.06|-5.50|0.774
91785802|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|0.4||||0.645|TWO_SIDED|95.0|-7.15|8.03|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 28||8.03|-7.15|0.645
91601601|NCT02288247|183095207|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.027|TWO_SIDED|95.0|0.53|0.96||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.96|0.53|0.027
91601602|NCT02288247|183095208|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.002|TWO_SIDED|95.0|0.41|0.82||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.82|0.41|0.002
91601603|NCT02288247|183095210|SUPERIORITY|||||||0.142||||||From the Cochran-Mantel-Haenszel test stratified by disease progression (radiographic, non-radiographic) in Period 1.|Cochran-Mantel-Haenszel|||||||0.142
91601604|NCT02288247|183095213|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.994|TWO_SIDED|95.0|0.47|2.13||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||2.13|0.47|0.994
91601605|NCT01235962|183095216|SUPERIORITY||Adjusted Hazard Ratio|0.862||||0.1649|TWO_SIDED|95.0|0.699|1.063|||Stratified Log-Rank|||||1.063|0.699|0.1649
91601606|NCT01235962|183095217|SUPERIORITY||Adjusted Hazard Ratio|0.998||||0.988|TWO_SIDED|95.0|0.759|1.311|||Stratified Log-Rank|||||1.311|0.759|0.9880
91601607|NCT01235962|183095219|SUPERIORITY||Adjusted Hazard Ratio|0.802||||0.0126|TWO_SIDED|95.0|0.675|0.954|||Stratified Log-Rank|||||0.954|0.675|0.0126
91601608|NCT01235962|183095220|SUPERIORITY||Adjusted Hazard Ratio|1.001||||0.9959|TWO_SIDED|95.0|0.796|1.257|||Stratified Log-Rank|||||1.257|0.796|0.9959
91601609|NCT01235962|183095222|SUPERIORITY||Adjusted Hazard Ratio|0.693||||0.0201|TWO_SIDED|95.0|0.51|0.943|||Stratified Log-Rank|||||0.943|0.510|0.0201
91601610|NCT01235962|183095223|SUPERIORITY||Adjusted Hazard Ratio|1.004||||0.9865|TWO_SIDED|95.0|0.662|1.521|||Stratified Log-Rank|||||1.521|0.662|0.9865
91601611|NCT01235962|183095224|SUPERIORITY||Mean Difference (Week 52)|-3.397|||<|0.001|TWO_SIDED|95.0|-4.486|-2.307|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.307|-4.486|<.001
91601612|NCT01235962|183095224|SUPERIORITY||Mean Difference (24M DFS FU)|-0.043||||0.93|TWO_SIDED|95.0|-1.003|0.917|||analysis of covariance|adjusted for baseline score using mixed-model||||0.917|-1.003|0.930
91601613|NCT01235962|183095224|SUPERIORITY||Mean Difference (36M DFS FU)|0.119||||0.828|TWO_SIDED|95.0|-0.958|1.196|||analysis of covariance|adjusted for baseline score using mixed-model||||1.196|-0.958|0.828
91601614|NCT01235962|183095224|SUPERIORITY||Mean Difference (48M DFS FU)|-0.347||||0.603|TWO_SIDED|95.0|-1.658|0.964|||analysis of covariance|adjusted for baseline score using mixed-model||||0.964|-1.658|0.603
91601615|NCT01235962|183095224|SUPERIORITY||Mean Difference (54M DFS FU)|-0.17||||0.841|TWO_SIDED|95.0|-1.843|1.503|||analysis of covariance|adjusted for baseline score using mixed-model||||1.503|-1.843|0.841
91601616|NCT01235962|183095225|SUPERIORITY||Mean Difference (Week 52)|-1.619|||<|0.001|TWO_SIDED|95.0|-2.283|-0.955|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.955|-2.283|<.001
91601617|NCT01235962|183095225|SUPERIORITY||Mean Difference (24 M DFS FU)|-0.114||||0.726|TWO_SIDED|95.0|-0.75|0.522|||analysis of covariance|adjusted for baseline score using mixed-model||||0.522|-0.750|0.726
91601618|NCT01235962|183095225|SUPERIORITY||Mean Difference (36 M DFS FU)|-0.09||||0.801|TWO_SIDED|95.0|-0.789|0.609|||analysis of covariance|adjusted for baseline score using mixed-model||||0.609|-0.789|0.801
91601619|NCT01235962|183095225|SUPERIORITY||Meat Difference (48 M DFS FU)|-0.212||||0.617|TWO_SIDED|95.0|-1.044|0.32|||analysis of covariance|adjusted for baseline score using mixed-model||||0.320|-1.044|0.617
91601620|NCT01235962|183095225|SUPERIORITY||Mean Difference (54 M DFS FU)|0.341||||0.565|TWO_SIDED|95.0|-0.828|1.51|||adjusted for baseline score using mixedm|||||1.510|-0.828|0.565
91601621|NCT01235962|183095226|SUPERIORITY||Mean Difference (Week 52)|-0.077||||0.238|TWO_SIDED|95.0|-0.205|0.051|||analysis of covariance|adjusted for baseline score using mixed-model||||0.051|-0.205|0.238
91601622|NCT01235962|183095226|SUPERIORITY||Mean Difference (24M DFS FU)|-0.052||||0.442|TWO_SIDED|95.0|-0.185|0.081|||analysis of covariance|adjusted for baseline score using mixed-model||||0.081|-0.185|0.442
91601623|NCT01235962|183095226|SUPERIORITY||Mean Difference (36M DFS FU)|0.016||||0.819|TWO_SIDED|95.0|-0.125|0.158|||analysis of covariance|adjusted for baseline score using mixed-model||||0.158|-0.125|0.819
91601624|NCT01235962|183095226|SUPERIORITY||Mean Difference (48M DFS FU)|-0.119||||0.223|TWO_SIDED|95.0|-0.311|0.073|||analysis of covariance|analysis of covariance adjusted for baseline score using mixed-model||||0.073|-0.311|0.223
91601625|NCT01235962|183095226|SUPERIORITY||Mean Difference (54M DFS FU)|-0.203||||0.085|TWO_SIDED|95.0|-0.435|0.028|||analysis of covariance|adjusted for baseline score using mixed-model||||0.028|-0.435|0.085
91650299|NCT00294723|183193071|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-4.0||||0.1396||95.0|-9.4|1.3||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.3|-9.4|0.1396
91709454|NCT01483599|183311505|SUPERIORITY_OR_OTHER||Difference in Percentage|-24.0|||||TWO_SIDED|95.0|-44.0|-4.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||-4.0|-44.0|
91785803|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|8.4||||0.08|TWO_SIDED|95.0|0.36|16.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 36||16.35|0.36|0.080
91601626|NCT01235962|183095227|SUPERIORITY||Mean Difference (Week 52)|-1.394|||<|0.001|TWO_SIDED|95.0|-1.66|-1.129|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.129|-1.660|<.001
91601627|NCT01235962|183095227|SUPERIORITY||Mean difference (24M DFS FU)|0.117||||0.083|TWO_SIDED|95.0|-0.015|0.249|||analysis of covariance|adjusted for baseline score using mixed-model||||0.249|-0.015|0.083
91601628|NCT01235962|183095227|SUPERIORITY||Mean Difference (36M DFS FU)|0.081||||0.307|TWO_SIDED|95.0|-0.074|0.236|||analysis of covariance|adjusted for baseline score using mixed-model||||0.236|-0.074|0.307
91601629|NCT01235962|183095227|SUPERIORITY||Mean Difference (48M DFS FU)|-0.029||||0.796|TWO_SIDED|95.0|-0.249|0.191|||analysis of covariance|adjusted for baseline score using mixed-model||||0.191|-0.249|0.796
91601630|NCT01235962|183095227|SUPERIORITY||Mean Difference (54M DFS FU)|-0.016||||0.885|TWO_SIDED|95.0|-0.237|0.205|||analysis of covariance|adjusted for baseline score using mixed-models||||0.205|-0.237|0.885
91601631|NCT01235962|183095228|SUPERIORITY||Mean Differencec (Week 52)|-0.27||||0.143|TWO_SIDED|95.0|-0.633|0.092|||analysis of covariance|adjusted for baseline score using mixed-model||||0.092|-0.633|0.143
91601632|NCT01235962|183095228|SUPERIORITY||Mean Difference (24M DFS FU)|0.069||||0.736|TWO_SIDED|95.0|-0.336|0.475|||analysis of covariance|adjusted for baseline score using mixed-model||||0.475|-0.336|0.736
91601633|NCT01235962|183095228|SUPERIORITY||Mean Difference (36M DFS FU)|0.188||||0.397|TWO_SIDED|95.0|-0.247|0.623|||analysis of covariance|adjusted for baseline score using mixed-model||||0.623|-0.247|0.397
91601634|NCT01235962|183095228|SUPERIORITY||Mean Difference (48M DFS FU)|0.081||||0.781|TWO_SIDED|95.0|-0.488|0.649|||analysis of covariance|adjusted for baseline score using mixed-model||||0.649|-0.488|0.781
91601635|NCT01235962|183095228|SUPERIORITY||Mean Difference (54M DFS FU)|-0.278||||0.503|TWO_SIDED|95.0|-1.094|0.539|||analysis of covariance|adjusted for baseline score using mixed-model||||0.539|-1.094|0.503
91601636|NCT01235962|183095229|SUPERIORITY||Mean Difference (Week 52 thermo)|-0.717||||0.49|TWO_SIDED|95.0|-2.751|1.318|||analysis of covariance|adjusted for baseline score using mixed-model||||1.318|-2.751|0.490
91522746|NCT00261495|182920736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03||||0.297||95.0|-5.85|1.8||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.80|-5.85|0.297
91522747|NCT00261495|182920737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.205||95.0|-1.32|6.14||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.14|-1.32|0.205
91522748|NCT00261495|182920738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.35||||0.107||95.0|-7.43|0.73||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.73|-7.43|0.107
91522749|NCT00261495|182920739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.475||95.0|-2.8|6.0||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.00|-2.80|0.475
91522750|NCT00261495|182920740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.16||||0.02||95.0|-7.67|-0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||-0.65|-7.67|0.020
91522751|NCT00261495|182920741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88||95.0|-0.3|0.26||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.30|0.880
91522752|NCT00261495|182920742|SUPERIORITY_OR_OTHER|||||||0.32|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.320
91522753|NCT00261495|182920747|SUPERIORITY_OR_OTHER|||||||0.575|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.575
91522754|NCT00261495|182920748|SUPERIORITY_OR_OTHER|||||||0.807|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.807
91522755|NCT00261495|182920749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.118||95.0|-5.88|0.67|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-5.88|0.118
91522756|NCT00261495|182920750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.956||95.0|-3.08|2.91|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.91|-3.08|0.956
91522757|NCT00261495|182920751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.299||95.0|-0.08|0.26|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.08|0.299
91522758|NCT00261495|182920752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.471||95.0|-4.2|1.95|||ANCOVA||Mean difference calculated: hydromorphone minus oxymorphone|Exploratory comparison||1.95|-4.20|0.471
91522759|NCT00261495|182920753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.84||||0.025||95.0|0.48|7.19|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.19|0.48|0.025
91522760|NCT00261495|182920754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.556||95.0|-5.61|10.42|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||10.42|-5.61|0.556
91522761|NCT00261495|182920755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12||||0.551||95.0|-9.11|4.88|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.88|-9.11|0.551
91522762|NCT00261495|182920756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.98||||0.207||95.0|-7.63|1.66|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.66|-7.63|0.207
91522763|NCT00261495|182920757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||0.123||95.0|-5.6|0.68|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.68|-5.60|0.123
91522764|NCT00261495|182920758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.602||95.0|-4.27|2.48|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.48|-4.27|0.602
91522765|NCT00261495|182920759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.647||95.0|-2.14|3.44|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||3.44|-2.14|0.647
91522766|NCT00261495|182920760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.627||95.0|-0.17|0.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.10|-0.17|0.627
91522767|NCT00261495|182920761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.414||95.0|-4.45|1.84|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.84|-4.45|0.414
91522768|NCT00261495|182920762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.05||||0.01||95.0|0.94|7.16|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.16|0.94|0.010
91522769|NCT00261495|182920763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.955||95.0|-7.2|7.62|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.62|-7.20|0.955
91522770|NCT00261495|182920764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.669||95.0|-4.72|7.34|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.34|-4.72|0.669
91522771|NCT00261495|182920765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.595||95.0|-3.15|5.49|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||5.49|-3.15|0.595
91522772|NCT00261495|182920766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.543||95.0|-3.98|2.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.10|-3.98|0.543
91522773|NCT05383417|182920795|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
91522774|NCT05383417|182920796|SUPERIORITY|||||||0.18|||||||t-test, 1 sided|||||||0.18
91522775|NCT05383417|182920797|SUPERIORITY|||||||0.007|||||||t-test, 1 sided|Day 2||||||0.007
91522776|NCT05383417|182920797|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
91522777|NCT05383417|182920798|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Day 1||||||0.03
91522778|NCT05383417|182920798|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
91522779|NCT05383417|182920799|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 1||||||0.04
91522780|NCT05383417|182920800|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|Day2||||||0.02
91522781|NCT05383417|182920801|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91522782|NCT05383417|182920802|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
91522783|NCT05383417|182920803|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91522784|NCT05383417|182920804|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91522785|NCT05383417|182920805|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91522786|NCT05383417|182920806|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91601637|NCT01235962|183095229|SUPERIORITY||Mean Difference (24M DFS FU- thermo)|-0.285||||0.788|TWO_SIDED|95.0|-2.358|1.788|||analysis of covariance|adjusted for baseline score using mixed-model||||1.788|-2.358|0.788
91601638|NCT01235962|183095229|SUPERIORITY||Mean Difference (36M DFS FU- thermo)|1.18||||0.266|TWO_SIDED|95.0|-0.901|3.262|||analysis of covariance|adjusted for baseline score using mixed-model||||3.262|-0.901|0.266
91601639|NCT01235962|183095229|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.725||||0.57|TWO_SIDED|95.0|-1.779|3.229|||analysis of covariance|adjusted for baseline score using mixed-model||||3.229|-1.779|0.570
91601640|NCT01235962|183095229|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|2.023||||0.346|TWO_SIDED|95.0|-2.205|6.251|||analysis of covariance|adjusted for baseline score using mixed-model||||6.251|-2.205|0.346
91601641|NCT01235962|183095229|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.018||||0.111|TWO_SIDED|95.0|-0.04|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.040|0.111
91601642|NCT01235962|183095229|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.02||||0.094|TWO_SIDED|95.0|-0.044|0.003|||analysis of covariance|adjusted for baseline score using mixed-model||||0.003|-0.044|0.094
91601643|NCT01235962|183095229|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.01||||0.49|TWO_SIDED|95.0|-0.018|0.037|||analysis of covariance|adjusted for baseline score using mixed-model||||0.037|-0.018|0.490
91601644|NCT01235962|183095229|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.009||||0.58|TWO_SIDED|95.0|-0.043|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.043|0.580
91601645|NCT01235962|183095229|SUPERIORITY||Mean Difference (54M DFS FU - UI)|0.017||||0.473|TWO_SIDED|95.0|-0.029|0.063|||analysis of covariance|adjusted for baseline score using mixed-model||||0.063|-0.029|0.473
91601646|NCT01235962|183095230|SUPERIORITY||Mean Difference (Week 52)|-3.536|||<|0.001|TWO_SIDED|95.0|-4.466|-2.606|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.606|-4.466|<.001
91601647|NCT01235962|183095230|SUPERIORITY||Mean difference (24M DFS FU)|-0.102||||0.812|TWO_SIDED|95.0|-0.942|0.738|||analysis of covariance|adjusted for baseline score using mixed-model||||0.738|-0.942|0.812
91601648|NCT01235962|183095230|SUPERIORITY||Mean Difference (36M DFS FU)|0.233||||0.621|TWO_SIDED|95.0|-0.69|1.155|||analysis of covariance|adjusted for baseline score using mixed-model||||1.155|-0.690|0.621
91601649|NCT01235962|183095230|SUPERIORITY||Mean Difference (48M DFS FU)|0.082||||0.878|TWO_SIDED|95.0|-0.959|1.122|||analysis of covariance|adjusted for baseline score using mixed-model||||1.122|-0.959|0.878
91709455|NCT01483599|183311505|SUPERIORITY_OR_OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-17.9|23.5||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||23.5|-17.9|
91601650|NCT01235962|183095230|SUPERIORITY||Mean Difference (54M DFS FU)|0.412||||0.533|TWO_SIDED|95.0|-0.887|1.712|||analysis of covariance|adjusted for baseline score using mixed-model||||1.712|-0.887|0.533
91601651|NCT01235962|183095231|SUPERIORITY||Mean Difference (Week 52)|-1.515|||<|0.001|TWO_SIDED|95.0|-2.078|-0.952|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.952|-2.078|<.001
91601652|NCT01235962|183095231|SUPERIORITY||Mean Difference (24M DFS FU)|0.014||||0.961|TWO_SIDED|95.0|-0.534|0.561|||analysis of covariance|adjusted for baseline score using mixed-model||||0.561|-0.534|0.961
91601653|NCT01235962|183095231|SUPERIORITY||Mean Difference (36M DFS FU)|0.043||||0.888|TWO_SIDED|95.0|-0.555|0.641|||analysis of covariance|adjusted for baseline score using mixed-model||||0.641|-0.555|0.888
91601654|NCT01235962|183095231|SUPERIORITY||Mean Difference (48M DFS FU)|-0.061||||0.858|TWO_SIDED|95.0|-0.736|0.614|||analysis of covariance|adjusted for baseline score using mixed-model||||0.614|-0.736|0.858
91601655|NCT01235962|183095231|SUPERIORITY||Mean Difference (54M DFS FU)|0.452||||0.3|TWO_SIDED|95.0|-0.404|1.309|||analysis of covariance|adjusted for baseline score using mixed-model||||1.309|-0.404|0.300
91601656|NCT01235962|183095232|SUPERIORITY||Mean Difference (Week 52)|-0.103||||0.059|TWO_SIDED|95.0|-0.211|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.211|0.059
91601657|NCT01235962|183095232|SUPERIORITY||Mean Difference (24M DFS FU)|-0.041||||0.487|TWO_SIDED|95.0|-0.155|0.074|||analysis of covariance|adjusted for baseline score using mixed-model||||0.074|-0.155|0.487
91601658|NCT01235962|183095232|SUPERIORITY||Mean Difference (36M DFS FU)|0.037||||0.885|TWO_SIDED|95.0|-0.085|0.16|||analysis of covariance|adjusted for baseline score using mixed-model||||0.160|-0.085|0.885
91601659|NCT01235962|183095232|SUPERIORITY||Mean Difference (48M DFS FU)|-0.032||||0.676|TWO_SIDED|95.0|-0.183|0.119|||analysis of covariance|adjusted for baseline score using mixed-model||||0.119|-0.183|0.676
91601660|NCT01235962|183095232|SUPERIORITY||Mean Difference (54M DFS FU)|-0.015||||0.859|TWO_SIDED|95.0|-0.183|0.153|||analysis of covariance|adjusted for baseline score using mixed-model||||0.153|-0.183|0.859
91601661|NCT01235962|183095233|SUPERIORITY||Mean Diffeence (Week 52)|-1.535|||<|0.001|TWO_SIDED|95.0|-1.769|-1.3|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.300|-1.769|<.001
91709456|NCT01483599|183311505|SUPERIORITY_OR_OTHER||Difference in Percentage|20.4|||||TWO_SIDED|95.0|1.5|39.3||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||39.3|1.5|
91650300|NCT00294723|183193071|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.9||||0.2968||95.0|-8.3|2.5||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.5|-8.3|0.2968
91650301|NCT00294723|183193071|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-1.2||||0.6639||95.0|-6.5|4.1||2-sided significance level 5%|ANCOVA|||Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||4.1|-6.5|0.6639
91650302|NCT00294723|183193072|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.81||||0.172||95.0|-9.28|1.66||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.66|-9.28|0.1720
91650303|NCT00294723|183193072|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.906||95.0|-5.82|5.16||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.16|-5.82|0.9060
91709457|NCT01483599|183311505|SUPERIORITY_OR_OTHER||Difference in Percentage|27.7|||||TWO_SIDED|95.0|9.8|45.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||45.6|9.8|
91785804|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|9.6||||0.025|TWO_SIDED|95.0|1.49|17.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 44||17.68|1.49|0.025
91601662|NCT01235962|183095233|SUPERIORITY||Mean Diffeence (24M DFS FU)|0.089||||0.127|TWO_SIDED|95.0|-0.025|0.202|||analysis of covariance|adjusted for baseline score using mixed-model||||0.202|-0.025|0.127
91601663|NCT01235962|183095233|SUPERIORITY||Mean Diffeence (36M DFS FU)|0.123||||0.069|TWO_SIDED|95.0|-0.009|0.255|||analysis of covariance|adjusted for baseline score using mixed-model||||0.255|-0.009|0.069
91601664|NCT01235962|183095233|SUPERIORITY||Mean Diffeence (48M DFS FU)|0.049||||0.544|TWO_SIDED|95.0|-0.11|0.208|||analysis of covariance|adjusted for baseline score using mixed-model||||0.208|-0.110|0.544
91601665|NCT01235962|183095233|SUPERIORITY||Mean Difference (54M DFS FU)|0.061||||0.518|TWO_SIDED|95.0|-0.124|0.246|||analysis of covariance|adjusted for baseline score using mixed-model||||0.246|-0.124|0.518
91785805|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.088|TWO_SIDED|95.0|1.02|16.88|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 52||16.88|1.02|0.088
91785806|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Baseline||1.81|-0.59|0.358
91601666|NCT01235962|183095234|SUPERIORITY||Mean Diffeence (Week 52)|-0.374||||0.022|TWO_SIDED|95.0|-0.695|-0.053|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.053|-0.695|0.022
91601667|NCT01235962|183095234|SUPERIORITY||Mean Diffeence (24M DFS FU)|-0.104||||0.567|TWO_SIDED|95.0|-0.462|0.253|||analysis of covariance|adjusted for baseline score using mixed-model||||0.253|-0.462|0.567
91601668|NCT01235962|183095234|SUPERIORITY||Mean Difference (36M DFS FU)|0.072||||0.706|TWO_SIDED|95.0|-0.302|0.446|||analysis of covariance|adjusted for baseline score using mixed-model||||0.446|-0.302|0.706
91601669|NCT01235962|183095234|SUPERIORITY||Mean Difference (48M DFS FU)|0.12||||0.612|TWO_SIDED|95.0|-0.343|0.583|||analysis of covariance|adjusted for baseline score using mixed-model||||0.583|-0.343|0.612
91601670|NCT01235962|183095234|SUPERIORITY||Mean Difference (54M DFS FU)|-0.045||||0.87|TWO_SIDED|95.0|-0.587|0.496|||analysis of covariance|adjusted for baseline score using mixed-model||||0.496|-0.587|0.870
91601671|NCT01235962|183095235|SUPERIORITY||Mean Difference (Week 52 - thermo.)|-2.116||||0.018|TWO_SIDED|95.0|-3.872|-0.359|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.359|-3.872|0.018
91601672|NCT01235962|183095235|SUPERIORITY||Mean Difference (24M DFS FU - thermo)|-0.253||||0.778|TWO_SIDED|95.0|-2.014|1.508|||analysis of covariance|adjusted for baseline score using mixed-model||||1.508|-2.014|0.778
91601673|NCT01235962|183095235|SUPERIORITY||Mean Difference (36M DFS FU - thermo)|0.847||||0.376|TWO_SIDED|95.0|-1.03|2.724|||analysis of covariance|adjusted for baseline score using mixed-model||||2.724|-1.030|0.376
91601674|NCT01235962|183095235|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.131||||0.905|TWO_SIDED|95.0|-2.032|2.294|||analysis of covariance|adjusted for baseline score using mixed-model||||2.294|-2.032|0.905
91601675|NCT01235962|183095235|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|0.401||||0.768|TWO_SIDED|95.0|-2.269|3.071|||analysis of covariance|adjusted for baseline score using mixed-model||||3.071|-2.269|0.768
91601676|NCT01235962|183095235|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.026||||0.007|TWO_SIDED|95.0|-0.044|-0.007|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.007|-0.044|0.007
91601677|NCT01235962|183095235|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.016||||0.13|TWO_SIDED|95.0|-0.036|0.005|||analysis of covariance|adjusted for baseline score using mixed-model||||0.005|-0.036|0.130
91601678|NCT01235962|183095235|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.007||||0.52|TWO_SIDED|95.0|-0.015|0.03|||analysis of covariance|adjusted for baseline score using mixed-model||||0.030|-0.015|0.520
91601679|NCT01235962|183095235|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.014||||0.276|TWO_SIDED|95.0|-0.04|0.011|||analysis of covariance|adjusted for baseline score using mixed-model||||0.011|-0.040|0.276
91601680|NCT01235962|183095235|SUPERIORITY||Mean Difference (54M DFS FU - UI)|-0.007||||0.665|TWO_SIDED|95.0|-0.037|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.037|0.665
91650304|NCT00294723|183193072|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2089||95.0|-8.91|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.91|0.2089
91785807|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.258|TWO_SIDED|95.0|-3.57|10.13|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 24||10.13|-3.57|0.258
91785808|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|17.7||||0.005|TWO_SIDED|95.0|7.49|27.92|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 28||27.92|7.49|0.005
91601681|NCT01727258|183095239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.85|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|7.45|14.25||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.25|7.45|<0.001
91601682|NCT01727258|183095239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|1.729||0.314|TWO_SIDED|95.0|-5.16|1.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-5.16|0.314
91601683|NCT01727258|183095239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|9.17|16.03||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||16.03|9.17|<0.001
91601684|NCT01727258|183095240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|1.177|<|0.001|TWO_SIDED|95.0|3.76|8.41||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.41|3.76|<0.001
91709458|NCT01483599|183311505|SUPERIORITY_OR_OTHER||Difference in Percentage|25.4|||||TWO_SIDED|95.0|7.2|43.6||||||||43.6|7.2|
91785809|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.93|37.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 36||37.55|16.93|<0.001
91785810|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|32.0|||<|0.001|TWO_SIDED|95.0|21.83|42.23|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 44||42.23|21.83|<0.001
91785811|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|28.3|||<|0.001|TWO_SIDED|95.0|18.0|38.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 52||38.69|18.00|<0.001
91785812|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|3.0||||0.672|TWO_SIDED|95.0|-5.51|11.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 24||11.51|-5.51|0.672
91601685|NCT01727258|183095240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.183||0.881|TWO_SIDED|95.0|-2.16|2.52||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.52|-2.16|0.881
91601686|NCT01727258|183095240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|STANDARD_ERROR_OF_MEAN|1.182|<|0.001|TWO_SIDED|95.0|3.57|8.24||Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|3.57|<0.001
91601687|NCT01727258|183095241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.866||0.02|TWO_SIDED|95.0|-12.38|-1.05||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.05|-12.38|0.020
91601688|NCT01727258|183095241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|2.86||0.964|TWO_SIDED|95.0|-5.52|5.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.78|-5.52|0.964
91601689|NCT01727258|183095241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|2.845||0.017|TWO_SIDED|95.0|-12.47|-1.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.23|-12.47|0.017
91601690|NCT01727258|183095242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|3.327||0.039|TWO_SIDED|95.0|-13.5|-0.35||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.35|-13.50|0.039
91601691|NCT01727258|183095242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|STANDARD_ERROR_OF_MEAN|3.317||0.13|TWO_SIDED|95.0|-1.5|11.61||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.61|-1.50|0.130
91601692|NCT01727258|183095242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.98|STANDARD_ERROR_OF_MEAN|3.313|<|0.001|TWO_SIDED|95.0|-18.53|-5.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.43|-18.53|<0.001
91601693|NCT01727258|183095243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|STANDARD_ERROR_OF_MEAN|3.163||0.01|TWO_SIDED|95.0|-14.51|-2.0||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-2.00|-14.51|0.010
91601694|NCT01727258|183095243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|3.16||0.179|TWO_SIDED|95.0|-1.98|10.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||10.51|-1.98|0.179
91785813|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.556|TWO_SIDED|95.0|-8.03|8.0|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 28||8.00|-8.03|0.556
91601695|NCT01727258|183095243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.52|STANDARD_ERROR_OF_MEAN|3.172|<|0.001|TWO_SIDED|95.0|-18.79|-6.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.25|-18.79|<0.001
91601696|NCT01727258|183095244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.93|STANDARD_ERROR_OF_MEAN|3.543|<|0.001|TWO_SIDED|95.0|-18.93|-4.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.93|-18.93|<0.001
91601697|NCT01727258|183095244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.54|STANDARD_ERROR_OF_MEAN|3.534||0.119|TWO_SIDED|95.0|-1.44|12.53||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||12.53|-1.44|0.119
91709459|NCT01483599|183311506|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.4|||||TWO_SIDED|95.0|-37.7|6.9||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||6.9|-37.7|
91601698|NCT01727258|183095244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-24.52|-10.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-10.42|-24.52|<0.001
91601699|NCT01890421|183095270|SUPERIORITY||Sensitivity Difference|-0.7||||0.8694|ONE_SIDED|95.0|-8.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||-8.5|0.8694
91709460|NCT01483599|183311506|SUPERIORITY_OR_OTHER||Difference in Percentage|10.8|||||TWO_SIDED|95.0|-10.7|32.4||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||32.4|-10.7|
91785814|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|10.3||||0.022|TWO_SIDED|95.0|2.07|18.45|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 36||18.45|2.07|0.022
91785815|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.047|TWO_SIDED|95.0|0.85|17.25|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 44||17.25|0.85|0.047
91785816|NCT01578850|183452405|SUPERIORITY_OR_OTHER||Difference in proportions|12.1||||0.031|TWO_SIDED|95.0|3.7|20.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 52||20.57|3.70|0.031
91785817|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.049|TWO_SIDED|95.0|-4.19|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 28||-0.01|-4.19|0.049
91785818|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.72|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 36||-1.05|-5.72|0.005
91785819|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.37|-1.67|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 44||-1.67|-6.37|<0.001
91785820|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.36|-1.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 52||-1.68|-6.36|<0.001
91785821|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.047|TWO_SIDED|95.0|-4.4|-0.03|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 28||-0.03|-4.40|0.047
91785822|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.004|TWO_SIDED|95.0|-5.97|-1.12|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 36||-1.12|-5.97|0.004
91785823|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33|||<|0.001|TWO_SIDED|95.0|-6.78|-1.88|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 44||-1.88|-6.78|<0.001
91785824|NCT01578850|183452407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27|||<|0.001|TWO_SIDED|95.0|-6.7|-1.84|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 52||-1.84|-6.70|<0.001
91785825|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|-0.2||||0.742|TWO_SIDED|95.0|-4.21|3.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 24||3.90|-4.21|0.742
91785826|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|9.8||||0.143|TWO_SIDED|95.0|2.45|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 28||17.06|2.45|0.143
91785827|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|11.4||||0.111|TWO_SIDED|95.0|3.31|19.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 36||19.51|3.31|0.111
91785828|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|10.1||||0.175|TWO_SIDED|95.0|1.8|18.49|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 44||18.49|1.80|0.175
91785829|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|10.8||||0.088|TWO_SIDED|95.0|2.49|19.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 52||19.05|2.49|0.088
91785830|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|2.5||||0.584|TWO_SIDED|95.0|-4.78|9.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 24||9.75|-4.78|0.584
91785831|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|11.5||||0.226|TWO_SIDED|95.0|1.59|21.34|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 28||21.34|1.59|0.226
91601700|NCT01890421|183095270|SUPERIORITY||Sensitivity Difference|29.1|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||21.7|<0.0001
91601701|NCT01890421|183095270|SUPERIORITY||Sensitivity Difference|24.1|||<|0.0001|ONE_SIDED|95.0|16.6||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||16.6|<0.0001
91601702|NCT01890421|183095271|SUPERIORITY||Sensitivity Difference]|7.4||||0.0455|ONE_SIDED|95.0|0.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||0.5|0.0455
91601703|NCT01890421|183095271|SUPERIORITY||Sensitivity Difference]|34.3|||<|0.0001|ONE_SIDED|95.0|25.2||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||25.2|<0.0001
91601704|NCT01890421|183095271|SUPERIORITY||Sensitivity Difference|30.6|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||21.7|<0.0001
91601705|NCT01890421|183095276|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.5|35.8|||McNemar 2-sided test,alpha level of 5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||35.8|18.5|<0.0001
91650305|NCT00294723|183193073|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.04||||0.2749||95.0|-8.51|2.42||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.42|-8.51|0.2749
91601706|NCT01890421|183095276|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|19.9|34.4|||McNemar 2-sided test,alpha level of 10%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||34.4|19.9|<0.0001
91785832|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|17.2||||0.012|TWO_SIDED|95.0|6.76|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 36||27.56|6.76|0.012
91785833|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.006|TWO_SIDED|95.0|8.59|29.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 44||29.35|8.59|0.006
91785834|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in Proportions|17.7||||0.014|TWO_SIDED|95.0|7.3|28.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 52||28.16|7.30|0.014
91785835|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in Proportions|-2.7||||0.702|TWO_SIDED|95.0|-13.49|8.11|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 24||8.11|-13.49|0.702
91785836|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|7.1||||0.378|TWO_SIDED|95.0|-3.37|17.5|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 28||17.50|-3.37|0.378
91601707|NCT04871711|183095286|SUPERIORITY||Risk Difference (RD)|9.8||||0.006|TWO_SIDED|95.0|3.6|16.1||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||16.1|3.6|0.006
91601708|NCT04871711|183095287|SUPERIORITY||Risk Difference (RD)|24.1|||<|0.001|TWO_SIDED|95.0|15.5|32.6||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.6|15.5|<0.001
91601709|NCT04871711|183095288|SUPERIORITY||Risk Difference (RD)|22.8|||<|0.001|TWO_SIDED|95.0|14.0|31.7||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||31.7|14.0|<0.001
91601710|NCT04871711|183095289|SUPERIORITY||Risk Difference (RD)|12.3||||0.001|TWO_SIDED|95.0|5.7|18.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||18.9|5.7|0.001
91613680|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.86||||0.001|TWO_SIDED|95.0|1.28|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Methods causing periods to stop are safe.||2.71|1.28|0.001
91613681|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.15||||0.36|TWO_SIDED|95.0|0.85|1.57||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - LARC can be removed early||1.57|0.85|0.36
91785837|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|17.3||||0.004|TWO_SIDED|95.0|7.12|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 36||27.56|7.12|0.004
91785838|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|18.5||||0.001|TWO_SIDED|95.0|8.4|28.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 44||28.55|8.40|0.001
91785839|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|16.0||||0.005|TWO_SIDED|95.0|5.96|26.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 52||26.02|5.96|0.005
91785840|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|-0.3||||0.921|TWO_SIDED|95.0|-6.19|5.67|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 24||5.67|-6.19|0.921
91785841|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.41|TWO_SIDED|95.0|-2.19|8.86|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 28||8.86|-2.19|0.410
91601711|NCT04871711|183095290|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.001|TWO_SIDED|95.0|5.3|15.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||15.6|5.3|<0.001
91785842|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|6.4||||0.073|TWO_SIDED|95.0|0.41|12.48|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 36||12.48|0.41|0.073
91601712|NCT04871711|183095291|SUPERIORITY||Risk Difference (RD)|21.0|||<|0.001|TWO_SIDED|95.0|12.6|29.4||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.4|12.6|<0.001
91601713|NCT04871711|183095292|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
91601714|NCT04871711|183095293|SUPERIORITY||Risk Difference (RD)|9.3||||0.004|TWO_SIDED|95.0|3.8|14.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||14.7|3.8|0.004
91601715|NCT04871711|183095294|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.4|30.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.6|14.4|<0.001
91601716|NCT04871711|183095295|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
91601717|NCT04871711|183095296|SUPERIORITY||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|30.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.9|12.4|<0.001
91601718|NCT04871711|183095297|SUPERIORITY||Risk Difference (RD)|23.9|||<|0.001|TWO_SIDED|95.0|15.2|32.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.7|15.2|<0.001
91601719|NCT04871711|183095298|SUPERIORITY||Risk Difference (RD)|19.6|||<|0.001|TWO_SIDED|95.0|11.8|27.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.5|11.8|<0.001
91785843|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|4.6||||0.219|TWO_SIDED|95.0|-0.97|10.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 44||10.08|-0.97|0.219
91785844|NCT01578850|183452409|SUPERIORITY_OR_OTHER||Difference in proportions|5.9||||0.196|TWO_SIDED|95.0|-0.6|12.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 52||12.40|-0.60|0.196
91785845|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.062|TWO_SIDED|95.0|-1.84|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 28||0.05|-1.84|0.062
91785846|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.015|TWO_SIDED|95.0|-2.41|-0.27|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 36||-0.27|-2.41|0.015
91601720|NCT04871711|183095299|SUPERIORITY||Risk Difference (RD)|17.2|||<|0.001|TWO_SIDED|95.0|10.1|24.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||24.3|10.1|<0.001
91601721|NCT04871711|183095300|SUPERIORITY||Risk Difference (RD)|25.7|||<|0.001|TWO_SIDED|95.0|17.2|34.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||34.3|17.2|<0.001
91601722|NCT04871711|183095301|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|15.5|33.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.0|15.5|<0.001
91601723|NCT04871711|183095302|SUPERIORITY||Mean Difference (Net)|-35.2|||<|0.001|TWO_SIDED|95.0|-46.7|-23.8||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-23.8|-46.7|<0.001
91601724|NCT04871711|183095303|SUPERIORITY||Mean Difference (Net)|-3.6|||<|0.001|TWO_SIDED|95.0|-4.7|-2.6||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.6|-4.7|<0.001
91601725|NCT04871711|183095304|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.2|<0.001
91601726|NCT04871711|183095305|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.3|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.3|<0.001
91601727|NCT04871711|183095306|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.0|-2.1|<0.001
91613682|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|2.76|||<|0.0001|TWO_SIDED|95.0|1.72|4.41||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - Copper IUD can act as EC||4.41|1.72|<0.0001
91709461|NCT01483599|183311506|SUPERIORITY_OR_OTHER||Difference in Percentage|22.7|||||TWO_SIDED|95.0|1.8|43.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||43.6|1.8|
91709462|NCT01483599|183311506|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|95.0|8.5|49.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||49.0|8.5|
91785847|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65||||0.003|TWO_SIDED|95.0|-2.72|-0.57|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 44||-0.57|-2.72|0.003
91785848|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.002|TWO_SIDED|95.0|-2.85|-0.66|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 52||-0.66|-2.85|0.002
91785849|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.68|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 28||0.50|-0.77|0.680
91785850|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.437|TWO_SIDED|95.0|-1.04|0.45|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 36||0.45|-1.04|0.437
91601728|NCT04871711|183095307|SUPERIORITY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.45||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.45|-0.83|<0.001
91601729|NCT04871711|183095308|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.79|-0.4||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.40|-0.79|<0.001
91601730|NCT04871711|183095309|SUPERIORITY||Risk Difference (RD)|24.5|||<|0.001|TWO_SIDED|95.0|15.0|33.9||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.9|15.0|<0.001
91601731|NCT01665144|183095311|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0134|TWO_SIDED|95.0|0.65|0.95|||Cox proportional hazards model|||||0.95|0.65|0.0134
91601732|NCT01665144|183095312|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4398|TWO_SIDED|95.0|0.8|1.1|||Cox proportional hazards model|||||1.10|0.80|0.4398
91601733|NCT01665144|183095313|SUPERIORITY||Mean Difference (Final Values)|-613.1|STANDARD_ERROR_OF_MEAN|95.39|<|0.0001|TWO_SIDED|95.0|-800.2|-426.0|||Mixed model for repeated measures|||Month 12||-426.0|-800.2|<0.0001
91601734|NCT01665144|183095313|SUPERIORITY||Mean Difference (Final Values)|-777.5|STANDARD_ERROR_OF_MEAN|108.62|<|0.0001|TWO_SIDED|95.0|-990.6|-564.4|||Mixed model for repeated measures|||Month 24||-564.4|-990.6|<0.0001
91601735|NCT01665144|183095313|SUPERIORITY||Mean Difference (Final Values)|-695.3|STANDARD_ERROR_OF_MEAN|92.79|<|0.0001|TWO_SIDED|95.0|-877.3|-513.3|||Mixed model for repeated measures|||Average over Month 12 and Month 24||-513.3|-877.3|<0.0001
91601736|NCT01665144|183095314|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0058|TWO_SIDED|95.0|0.6|0.92|||Cox proportional hazards model|||||0.92|0.60|0.0058
91601737|NCT01665144|183095315|SUPERIORITY||ARR ratio|0.445|||<|0.0001|TWO_SIDED|95.0|0.337|0.587|||Negative binomial regression model|||||0.587|0.337|<0.0001
91601738|NCT01665144|183095316|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.7|||Cox proportional hazards model|||||0.70|0.41|<0.0001
91601739|NCT01665144|183095318|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.03||0.0764|TWO_SIDED|95.0|-3.85|0.19|||Repeated measures model|||Month 12||0.19|-3.85|0.0764
91601740|NCT01665144|183095318|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.359||0.3671|TWO_SIDED|95.0|-3.89|1.44|||Repeated measures model|||Month 24||1.44|-3.89|0.3671
91601741|NCT01665144|183095319|SUPERIORITY||Rate ratio|0.126|||<|0.0001|TWO_SIDED|95.0|0.083|0.191|||Negative binomial regression model|||Month 12||0.191|0.083|<0.0001
91601742|NCT01665144|183095319|SUPERIORITY||Rate ratio|0.178|||<|0.0001|TWO_SIDED|95.0|0.087|0.362|||Negative binomial regression model|||Month 24||0.362|0.087|<0.0001
91601743|NCT01665144|183095320|SUPERIORITY||Rate ratio|0.266|||<|0.0001|TWO_SIDED|95.0|0.215|0.328|||Regression model|Repeated measures negative binomial regression model||Month 12||0.328|0.215|<0.0001
91601744|NCT01665144|183095320|SUPERIORITY||Rate ratio|0.142|||<|0.0001|TWO_SIDED|95.0|0.103|0.196|||Regression model|Repeated measures negative binomial regression model||Month 24||0.196|0.103|<0.0001
91601745|NCT01665144|183095321|SUPERIORITY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.0367|<|0.0001|TWO_SIDED|95.0|0.103|0.247|||Repeated measures model|||Month 12||0.247|0.103|<0.0001
91601746|NCT01665144|183095321|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.0549||0.0196|TWO_SIDED|95.0|0.021|0.236|||Repeated measures model|||Month 24||0.236|0.021|0.0196
91601747|NCT01665144|183095322|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.11|||Cox proportional hazard model|||Without superimposed relapses at baseline||1.11|0.68|
91601748|NCT01665144|183095322|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.49|0.91|||Cox proportional hazard model|||With superimposed relapses at baseline||0.91|0.49|
91601749|NCT01665144|183095322|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||Cox proportional hazard model|||Without superimposed relapses post-treatment||1.06|0.69|
91601750|NCT01665144|183095322|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.53|1.19|||Cox proportional hazard model|||With superimposed relapses post-treatment||1.19|0.53|
91601751|NCT01665144|183095323|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.46|0.91|||Cox proportional hazard model|||Rapidly evolving patients||0.91|0.46|
91785851|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.131|TWO_SIDED|95.0|-1.31|0.17|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 44||0.17|-1.31|0.131
91601752|NCT01665144|183095323|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.69|1.09|||Cox proportional hazard model|||Not rapidly evolving patients||1.09|0.69|
91601753|NCT01665144|183095324|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.65|0.99|||Cox proportional hazard model|||With moderate or severe course of disease||0.99|0.65|
91601754|NCT01665144|183095324|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||Cox proportional hazard model|||Without moderate or severe course of disease||1.13|0.47|
91601755|NCT02105415|183095334|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.385|TWO_SIDED|95.0|-6.9|2.7|||ANCOVA|||5 minutes||2.7|-6.9|0.385
91601756|NCT02105415|183095334|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.241|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|||10 minutes||2.8|-10.8|0.241
91601757|NCT02105415|183095334|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.802|TWO_SIDED|95.0|-7.2|5.6|||ANCOVA|||15 minutes||5.6|-7.2|0.802
91601758|NCT02105415|183095335|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
91601759|NCT02105415|183095336|SUPERIORITY|||||||0.212|||||||ANCOVA|||Pre-treatment||||0.212
91785852|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.199|TWO_SIDED|95.0|-1.22|0.25|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 52||0.25|-1.22|0.199
91601760|NCT02105415|183095336|SUPERIORITY|||||||0.308|||||||ANCOVA|||New-onset pressors (within 3 minutes)||||0.308
91601761|NCT02105415|183095336|SUPERIORITY|||||||0.691|||||||ANCOVA|||Delayed-onset pressors (within 24 hrs)||||0.691
91601762|NCT02105415|183095338|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
91601763|NCT02105415|183095339|SUPERIORITY|||||||0.069|||||||ANCOVA|||Red blood cell||||0.069
91601764|NCT02105415|183095339|SUPERIORITY|||||||0.046|||||||ANCOVA|||Non-red blood cell||||0.046
91601765|NCT02105415|183095339|SUPERIORITY|||||||0.502|||||||ANCOVA|||Colloid||||0.502
91601766|NCT02105415|183095340|SUPERIORITY|||||||0.994|||||||ANCOVA|||||||0.994
91601767|NCT02105415|183095341|SUPERIORITY|||||||0.233|||||||ANCOVA|||||||0.233
91601768|NCT01462266|183095375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.009|TWO_SIDED|95.0|-8.3|-1.2|||Longitudinal data analysis|Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)||||-1.2|-8.3|0.009
91601769|NCT01106846|183095380|SUPERIORITY_OR_OTHER|||||||0.947|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.947
91601770|NCT03242954|183095402|SUPERIORITY||Cohen's f square|0.011|STANDARD_ERROR_OF_MEAN|0.208||0.5148|TWO_SIDED|95.0|0.001|0.101|||Regression, Linear|||||0.101|0.001|0.5148
91601771|NCT03242954|183095403|SUPERIORITY||Cohen's f square|0.306|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.169|0.389|||Regression, Linear|||||0.389|0.169|<.0001
91601772|NCT03242954|183095404|SUPERIORITY||Cohen's f square|0.008|STANDARD_ERROR_OF_MEAN|0.213||0.4324|TWO_SIDED|95.0|0.001|0.073|||GEE Linear model|||||0.073|0.001|0.4324
91601773|NCT03242954|183095405|SUPERIORITY||Cohen's f square|0.26|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.175|0.374|||GEE Linear model|||||0.374|0.175|<.0001
91601774|NCT00880750|183095406|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).|Mean Difference (Final Values)|-1.35|||||TWO_SIDED|90.0|-2.18|-0.51|||Mixed Models Analysis|||||-0.51|-2.18|
91601775|NCT00880750|183095407|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).|Mean Difference (Final Values)|-1.98|||||TWO_SIDED|90.0|-3.17|-0.8|||Mixed Models Analysis|||||-0.80|-3.17|
91601776|NCT00880750|183095408|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.34||||||90.0|1.26|1.42|||Mixed Models Analysis|After application of the log transformation AUC 0-48 was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.42|1.26|
91601777|NCT00880750|183095409|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.26||||||90.0|1.2|1.33|||Mixed Models Analysis|After application of the log transformation Cmax was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.33|1.20|
91785853|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.115|TWO_SIDED|95.0|-2.6|0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 28||0.28|-2.60|0.115
91601778|NCT00880750|183095410|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.01||||||90.0|0.0|0.5|||Wilcoxon (Hodges-Lehmann)|The median difference and 90% CI for the median difference was then calculated based on Hodges-Lehmann estimate for Wilcoxon's Signed Rank test||||0.50|0.00|
91601779|NCT02265913|183095412|EQUIVALENCE|provides 85% of success|Equivalence ratio|98.0|||||TWO_SIDED|90.0|92.0|105.0|||Fieller's method|||||105|92|
91601780|NCT00670007|183095417|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.279|||=|0.752|TWO_SIDED|95.0|-1.089|0.53||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval \[CI\] being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 \[CE1226\_4001\], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.530|-1.089|= 0.752
91601781|NCT00670007|183095417|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.371|||=|0.823|TWO_SIDED|95.0|-1.159|0.417||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.417|-1.159|= 0.823
91601782|NCT00670007|183095417|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.176|||=|0.648|TWO_SIDED|95.0|-1.09|0.738||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.738|-1.09|= 0.648
91601783|NCT00670007|183095418|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.53||||0.526|TWO_SIDED|95.0|-2.179|1.12||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||1.120|-2.179|0.526
91601784|NCT00670007|183095418|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.486||||0.558|TWO_SIDED|95.0|-2.126|1.154||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.154|-2.126|0.558
91601785|NCT00670007|183095418|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.019||||0.984|TWO_SIDED|95.0|-1.858|1.895||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.895|-1.858|0.984
91601786|NCT00670007|183095419|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.294||||0.883|TWO_SIDED|95.0|-3.645|4.233||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||4.233|-3.645|0.883
91601787|NCT00670007|183095419|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.151||||0.941|TWO_SIDED|95.0|-4.172|3.87||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||3.870|-4.172|0.941
91601788|NCT00670007|183095419|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.787||||0.404|TWO_SIDED|95.0|-2.44|6.014||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||6.014|-2.440|0.404
91709463|NCT01483599|183311506|SUPERIORITY_OR_OTHER||Difference in Percentage|32.9|||||TWO_SIDED|95.0|13.0|52.8||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||52.8|13.0|
91785854|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.017|TWO_SIDED|95.0|-3.42|-0.35|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 36||-0.35|-3.42|0.017
91601789|NCT00618722|183095429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.043|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.9|0.043
91601790|NCT00618722|183095429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.05|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.8|0.050
91709464|NCT01483599|183311507|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA on the van Der Waerden score|||||||0.008
91709465|NCT01483599|183311507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
91785855|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.004|TWO_SIDED|95.0|-3.91|-0.76|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 44||-0.76|-3.91|0.004
91785856|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.002|TWO_SIDED|95.0|-4.19|-0.97|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 52||-0.97|-4.19|0.002
91785857|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.368|TWO_SIDED|95.0|-1.13|0.42|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 28||0.42|-1.13|0.368
91601791|NCT00618722|183095429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.2|-0.7|0.249
91601792|NCT00618722|183095430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.003|TWO_SIDED|95.0|0.7|3.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||3.1|0.7|0.003
91601793|NCT00618722|183095430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.6|0.1|0.030
91601794|NCT00618722|183095430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.012|TWO_SIDED|95.0|0.4|2.8|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.8|0.4|0.012
91601795|NCT00618722|183095431|SUPERIORITY_OR_OTHER||Difference from Placebo|38.9||||0.015|TWO_SIDED|95.0|12.6|65.2|||Fisher Exact|||||65.2|12.6|0.015
91601796|NCT00618722|183095431|SUPERIORITY_OR_OTHER||Difference from Placebo|28.9||||0.096|TWO_SIDED|95.0|0.4|57.5|||Fisher Exact|||||57.5|0.4|0.096
91785858|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.208|TWO_SIDED|95.0|-1.46|0.32|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 36||0.32|-1.46|0.208
91601797|NCT00618722|183095431|SUPERIORITY_OR_OTHER||Difference from Placebo|44.7||||0.003|TWO_SIDED|95.0|20.6|68.8|||Fisher Exact|||||68.8|20.6|0.003
91601798|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.078|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.6|0.0|0.078
91601799|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.781|TWO_SIDED|95.0|-0.3|0.4|||Repeated easures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.3|0.781
91601800|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.5|-0.1|0.146
91601801|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.076|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|0.0|0.076
91601802|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.3|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.3|0.975
91601803|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.183|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.1|0.183
91601804|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.017|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.017
91709466|NCT01483599|183311507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
91785859|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.064|TWO_SIDED|95.0|-1.73|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 44||0.05|-1.73|0.064
91785860|NCT01578850|183452411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.081|TWO_SIDED|95.0|-1.66|0.1|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 52||0.10|-1.66|0.081
91601805|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.022|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.022
91601806|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.081|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.6|0.0|0.081
91650306|NCT00294723|183193073|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|0.43||||0.8765||95.0|-5.05|5.92||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.92|-5.05|0.8765
91650307|NCT00294723|183193073|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2088||95.0|-8.9|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.90|0.2088
91650308|NCT03255031|183193097|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.067
91650309|NCT03255031|183193098|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.004
91650310|NCT01809314|183193107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.||||<0.0001
91650311|NCT01809314|183193108|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.||||0.001
91785861|NCT01578850|183452413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.005|TWO_SIDED|95.0|-0.9|-0.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.16|-0.90|0.005
91650312|NCT03654898|183193146|SUPERIORITY||cross-tabulation|0.48||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
91650313|NCT03654898|183193146|SUPERIORITY||Odds Ratio (OR)|1.06||||0.67|TWO_SIDED|95.0|0.8|1.42|||Regression, Logistic|Adjusted logistic regression||||1.42|0.80|0.67
91785862|NCT01578850|183452413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.38|-1.18|<0.001
91785863|NCT01578850|183452413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.54|-1.35|<0.001
91601807|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.51|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.2|0.510
91785864|NCT01578850|183452413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.53|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.53|-1.33|<0.001
91601808|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.33|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.2|-0.5|0.330
91650314|NCT03654898|183193147|SUPERIORITY||Cross-tabulation|0.71||||0.4|TWO_SIDED||||||Chi-squared|||||||0.40
91650315|NCT03654898|183193148|SUPERIORITY||Cross-tabulation|0.5||||0.78|TWO_SIDED||||||Chi-squared|||Test 1 was for TFVdp while test 2 was for 3TCtp.||||0.78
91650316|NCT03654898|183193148|SUPERIORITY||Cross-tabulation|2.13||||0.34|TWO_SIDED||||||Chi-squared|||Test 2 was for 3TCtp while test 1 was for TFVdp.||||0.34
91650317|NCT02868281|183193184|OTHER||Odds Ratio (OR)|7.87||||0.027|TWO_SIDED|95.0|1.29|48.11|||Mixed effect logistic regression||The model included treatment, Baseline ACT total score, Baseline ACT total score squared, center, type of Baseline controller, gender and age, with the center as a random factor.|||48.11|1.29|0.027
91650318|NCT02868281|183193185|OTHER||Difference in Least Squares Mean|-0.1||||0.222|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.222
91650319|NCT02868281|183193185|OTHER||Difference in Least Squares Mean|-0.1||||0.156|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.156
91709467|NCT01483599|183311507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
91709468|NCT01483599|183311507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
91650320|NCT02868281|183193185|OTHER||Difference in Least Squares Mean|-0.1||||0.245|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.245
91650321|NCT02868281|183193185|OTHER||Difference in Least Squares Mean|-0.1||||0.057|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.057
91650322|NCT02868281|183193185|OTHER||Difference in Least Squares Mean|-0.1||||0.151|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.151
91650323|NCT02868281|183193185|OTHER||Difference in Least Squares Mean|-0.1||||0.114|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.114
91601809|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.3|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.3|0.720
91601810|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.205|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.1|0.205
91601811|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.41|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.2|-0.5|0.410
91601812|NCT00618722|183095432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.436|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.2|0.436
91650324|NCT02868281|183193186|OTHER||Difference in Least Squares Mean|-0.05||||0.487|TWO_SIDED|95.0|-0.18|0.09|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.18|0.487
91650325|NCT02868281|183193186|OTHER||Difference in Least Squares Mean|-0.04||||0.546|TWO_SIDED|95.0|-0.16|0.09|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.16|0.546
91650326|NCT02868281|183193186|OTHER||Difference in Least Squares Mean|-0.06||||0.314|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.314
91650327|NCT02868281|183193186|OTHER||Difference in Least Squares Mean|-0.07||||0.197|TWO_SIDED|95.0|-0.19|0.04|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.04|-0.19|0.197
91650328|NCT02868281|183193186|OTHER||Difference in Least Squares Mean|-0.06||||0.282|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.282
91650329|NCT02868281|183193186|OTHER||Difference in Least Squares Mean|-0.03||||0.543|TWO_SIDED|95.0|-0.15|0.08|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.08|-0.15|0.543
91650330|NCT02868281|183193187|OTHER||Difference in Least Squares Mean|0.06||||0.273|TWO_SIDED|95.0|-0.059|0.18|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline FEV1, type of Baseline controller, gender and age, with the center as a random factor.|||0.180|-0.059|0.273
91785865|NCT01578850|183452415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.048|TWO_SIDED|95.0|-1.0|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.01|-1.00|0.048
91601813|NCT00618722|183095433|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.762|TWO_SIDED|95.0|-9.1|12.3|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||12.3|-9.1|0.762
91601814|NCT00618722|183095433|SUPERIORITY_OR_OTHER||LS mean Difference|5.2||||0.248|TWO_SIDED|95.0|-3.8|14.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||14.2|-3.8|0.248
91650331|NCT02868281|183193188|OTHER||Difference in Least Squares Mean|-12.0||||0.367|TWO_SIDED|95.0|-40.3|16.3|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.3|-40.3|0.367
91650332|NCT02868281|183193188|OTHER||Difference in Least Squares Mean|-7.2||||0.587|TWO_SIDED|95.0|-35.5|21.2|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.2|-35.5|0.587
91785866|NCT01578850|183452415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.44|-0.43|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.43|-1.44|<0.001
91601815|NCT00618722|183095433|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3||||0.061|TWO_SIDED|95.0|-0.4|19.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||19.1|-0.4|0.061
91650333|NCT02868281|183193188|OTHER||Difference in Least Squares Mean|-4.7||||0.721|TWO_SIDED|95.0|-33.1|23.7|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.7|-33.1|0.721
91650334|NCT02868281|183193188|OTHER||Difference in Least Squares Mean|-3.3||||0.801|TWO_SIDED|95.0|-31.7|25.1|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.1|-31.7|0.801
91650335|NCT02868281|183193188|OTHER||Difference in Least Squares Mean|-5.0||||0.704|TWO_SIDED|95.0|-33.3|23.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.4|-33.3|0.704
91785867|NCT01578850|183452415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.33|-0.33|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.33|-1.33|0.001
91601816|NCT00925600|183095435|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper bound of the 97.5% one-sided confidence interval, or equivalently upper bound of two-sided 95% confidence interval was less than the pre-specified non-inferiority bound of 10%.|Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|3.4||0.0026|TWO_SIDED|95.0|-6.3|7.2|||Mantel Haenszel|||The primary endpoint was summarized with the point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||7.2|-6.3|0.0026
91601817|NCT00925600|183095436|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-6.4|2.0||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||2.0|-6.4|
91601818|NCT00925600|183095437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.9|5.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||5.3|-5.9|
91601819|NCT00925600|183095438|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-7.6|3.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||3.3|-7.6|
91601820|NCT00624221|183095442|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.||||||0.1|TWO_SIDED|95.0|||||paired difference t-test|||||||0.10
91601821|NCT00200057|183095487|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
91601822|NCT00200057|183095488|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
91601823|NCT00200057|183095489|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
91601824|NCT00200057|183095490|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
91601825|NCT00200057|183095491|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
91650336|NCT02868281|183193188|OTHER||Difference in Least Squares Mean|-4.0||||0.762|TWO_SIDED|95.0|-32.4|24.5|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-32.4|0.762
91650337|NCT02868281|183193189|OTHER||Difference in Least Squares Mean|-12.8||||0.354|TWO_SIDED|95.0|-42.1|16.5|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.5|-42.1|0.354
91785868|NCT01578850|183452415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.31|-1.33|0.002
91785869|NCT01578850|183452417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.11||||0.033|TWO_SIDED|95.0|-27.07|-1.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-1.16|-27.07|0.033
91785870|NCT01578850|183452417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04||||0.013|TWO_SIDED|95.0|-30.39|-3.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-3.68|-30.39|0.013
91601826|NCT00200057|183095492|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
91601827|NCT00200057|183095493|SUPERIORITY_OR_OTHER||Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.79||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.79|0.62|<0.0001
91601828|NCT00778830|183095510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3176|||||TWO_SIDED|95.0|0.8078|2.1491||||||||2.1491|0.8078|
91601829|NCT05512949|183095514|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.7||||0.045|TWO_SIDED|95.0|0.5|1.0||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||1.0|0.5|0.045
91601830|NCT05512949|183095514|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.4||||0.162|TWO_SIDED|95.0|0.3|0.6||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||0.6|0.3|0.162
91601831|NCT05512949|183095517|SUPERIORITY|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
91601832|NCT05512949|183095517|SUPERIORITY|||||||0.708|||||||Wilcoxon (Mann-Whitney)|||||||0.708
91601833|NCT03988907|183095551|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.93|1.26||||||||1.26|0.93|
91601834|NCT03988907|183095552|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.20|1.02|
91601835|NCT03988907|183095553|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.16|||||TWO_SIDED|90.0|1.06|1.28||||||||1.28|1.06|
91601836|NCT03988907|183095554|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.12|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
91601837|NCT03988907|183095555|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|1.11|1.3||||||||1.30|1.11|
91601838|NCT03988907|183095556|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.27|||||TWO_SIDED|90.0|1.14|1.41||||||||1.41|1.14|
91601839|NCT04656990|183095576|SUPERIORITY||Slope|17.1|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91601840|NCT04656990|183095579|SUPERIORITY||Slope|3.4|||=|0.04|TWO_SIDED||||||Mixed Models Analysis|||||||=0.04
91601841|NCT03106779|183095629|SUPERIORITY||treatment difference in the MMR rate|12.2||||0.029|TWO_SIDED|95.0|2.19|22.3|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening||||22.30|2.19|0.029
91601842|NCT04233229|183095644|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|27.4|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|15.0|39.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||39.8|15.0|<.001
91601843|NCT04233229|183095645|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during diurnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|23.0|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|10.6|35.5||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||35.5|10.6|<.001
91601844|NCT04233229|183095646|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during nocturnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|40.8|STANDARD_ERROR_OF_MEAN|7.2|<|0.001|TWO_SIDED|95.0|25.8|55.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||55.8|25.8|<.001
91601845|NCT04233229|183095647|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-27.7|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-40.5|-15.0||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-15.0|-40.5|<.001
91601846|NCT04233229|183095648|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-20.1|STANDARD_ERROR_OF_MEAN|5.9||0.003|TWO_SIDED|95.0|-32.4|-7.9||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-7.9|-32.4|0.003
91650338|NCT02868281|183193189|OTHER||Difference in Least Squares Mean|-8.4||||0.538|TWO_SIDED|95.0|-37.8|21.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.0|-37.8|0.538
91650339|NCT02868281|183193189|OTHER||Difference in Least Squares Mean|-5.0||||0.716|TWO_SIDED|95.0|-34.4|24.5|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-34.4|0.716
91650340|NCT02868281|183193189|OTHER||Difference in Least Squares Mean|-3.1||||0.822|TWO_SIDED|95.0|-32.5|26.3|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||26.3|-32.5|0.822
91709469|NCT01483599|183311507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
91601847|NCT04233229|183095649|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.79|TWO_SIDED|95.0|-1.0|1.3||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||1.3|-1.0|0.79
91785871|NCT01578850|183452417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.54||||0.019|TWO_SIDED|95.0|-30.35|-2.73|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-2.73|-30.35|0.019
91601848|NCT04233229|183095650|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.84|TWO_SIDED|95.0|-0.3|0.4||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||0.4|-0.3|0.84
91601849|NCT04233229|183095651|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and glucose variability (% CV Coefficient of Variation) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|3.7|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-0.2|7.6||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||7.6|-0.2|0.060
91601850|NCT04233229|183095652|SUPERIORITY|Analysis of covariance (ANCOVA) model with 2 factors: HbA1c value at baseline and study group|Adjusted means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.9|-0.7||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-0.7|-1.9|<.001
91601851|NCT04233229|183095653|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and total daily insulin dose at selection|Adjusted means difference|-18.5|STANDARD_ERROR_OF_MEAN|28.5||0.52|TWO_SIDED|95.0|-78.2|41.2||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||41.2|-78.2|0.52
91601852|NCT04233229|183095654|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and body weight at study initiation visit|Adjusted means difference|2.8|STANDARD_ERROR_OF_MEAN|1.6||0.08|TWO_SIDED|95.0|-0.4|6.1||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||6.1|-0.4|0.08
91601853|NCT04652804|183095655|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|1.0|1.19||||||Reference group: Low Intensity Intervention||1.19|1.00|
91601854|NCT04652804|183095655|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.9|1.05||||||Reference Group: Low Intensity Intervention||1.05|0.90|
91601855|NCT04652804|183095655|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.8|1.15||||||Reference group: High Intensity Intervention||1.15|0.80|
91601856|NCT04652804|183095655|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.77|1.04||||||Reference group: High Intensity Intervention||1.04|0.77|
91601857|NCT03543410|183095687|SUPERIORITY||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.625||0.044|TWO_SIDED|95.0|-6.489|-0.09||nominal p-value|Mixed Models Analysis|||||-0.090|-6.489|0.044
91601858|NCT03543410|183095687|SUPERIORITY||Mean Difference (Final Values)|-3.128|STANDARD_ERROR_OF_MEAN|1.597||0.051|TWO_SIDED|95.0|-6.273|0.017||nominal p-value|Mixed Models Analysis|||||0.017|-6.273|0.051
91601859|NCT03543410|183095688|SUPERIORITY||Mean Difference (Final Values)|-0.281|STANDARD_ERROR_OF_MEAN|0.191||0.143|TWO_SIDED|95.0|-0.658|0.095||nominal p-value|Mixed Models Analysis|||||0.095|-0.658|0.143
91601860|NCT03543410|183095688|SUPERIORITY||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.187||0.243|TWO_SIDED|95.0|-0.588|0.15||nominal p-value|Mixed Models Analysis|||||0.150|-0.588|0.243
91650341|NCT02868281|183193189|OTHER||Difference in Least Squares Mean|-4.0||||0.767|TWO_SIDED|95.0|-33.4|25.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.4|-33.4|0.767
91785872|NCT01578850|183452417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.66||||0.007|TWO_SIDED|95.0|-33.78|-5.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-5.54|-33.78|0.007
91601861|NCT00820755|183095721|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.959||||0.1265|TWO_SIDED|95.0|0.736|1.25|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (interactive voice response system \[IVRS\]) and tumor response status at the end of combination therapy ('complete response \[CR\] or partial response \[PR\]' versus 'other').||1.250|0.736|0.1265
91601862|NCT00820755|183095723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.0622||95.0|0.613|0.976|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (IVRS) and tumor response status at the end of combination therapy ('CR or PR' versus 'other').||0.976|0.613|0.0622
91650342|NCT02868281|183193189|OTHER||Difference in Least Squares Mean|-3.8||||0.779|TWO_SIDED|95.0|-33.4|25.7|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.7|-33.4|0.779
91785873|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.21||||0.078|TWO_SIDED|95.0|-8.91|0.48|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 28||0.48|-8.91|0.078
91785874|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.54||||0.003|TWO_SIDED|95.0|-12.49|-2.59|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 36||-2.59|-12.49|0.003
91601863|NCT01486199|183095729|EQUIVALENCE|alpha=0.05||||||0.002|||||||t-test, 2 sided|||Comparing absorptive clearance in CF children vs adult controls||||0.002
91601864|NCT01486199|183095730|EQUIVALENCE|alpha = 0.05||||||0.2|||||||t-test, 2 sided|||Comparison of mucociliary clearance in CF children compared to healthy adults||||0.20
91601865|NCT01486199|183095731|EQUIVALENCE|alpha=0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparing absorptive clearance at t=0 vs t=2 years in pediatric CF subjects||||0.24
91601866|NCT01486199|183095732|EQUIVALENCE|alpha=0.05||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparing mucociliary clearance at t=0 and t=2yrs in pediatric CF subjects||||0.87
91601867|NCT02063035|183095733|SUPERIORITY|||||||0.1318|||||||Wilcoxon (Mann-Whitney)|||||||0.1318
91601868|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
91601869|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
91601870|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
91601871|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
91601872|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
91601873|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.003|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
91785875|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.19||||0.001|TWO_SIDED|95.0|-13.2|-3.18|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 44||-3.18|-13.20|0.001
91785876|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.001|TWO_SIDED|95.0|-13.64|-3.55|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 52||-3.55|-13.64|<0.001
91785877|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91||||0.017|TWO_SIDED|95.0|-10.75|-1.06|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 28||-1.06|-10.75|0.017
91601874|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.035|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.001|||
91601875|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.176|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.018|||
91601876|NCT03604445|183095739|OTHER||Probability of DLT rate in [0.16, 0.33)|0.129|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.83|||
91601877|NCT02551159|183095774|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.787|TWO_SIDED|95.0|0.69|1.32||2 sided|Log Rank|||Statistical analysis of number of deaths||1.32|0.69|0.787
91601878|NCT02551159|183095776|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.634|TWO_SIDED|95.0|0.8|1.39||2 sided|Log Rank|||||1.39|0.80|0.634
91601879|NCT02551159|183095778|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.287|TWO_SIDED|95.0|0.94|1.8||2 sided|Log Rank|||||1.80|0.94|0.287
91601880|NCT02551159|183095778|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.028|TWO_SIDED|95.0|0.99|1.76||2 sided|Log Rank|||||1.76|0.99|0.028
91785878|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.001|TWO_SIDED|95.0|-13.85|-3.34|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 36||-3.34|-13.85|0.001
91522787|NCT03243422|182920807|SUPERIORITY||change in Standard Deviation|0.002||||0.96|TWO_SIDED|95.0|-0.077|0.081|||Mixed Models Analysis|Three-level linear mixed effects model with an unstructured covariance matrix from the baseline and the year 3 in-person neurocognitive assessment||||0.081|-0.077|0.96
91601881|NCT02551159|183095779|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.1|0.37||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.37|0.10|<0.001
91601882|NCT02551159|183095779|SUPERIORITY||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.57||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.57|0.20|<0.001
91601883|NCT02551159|183095781|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.811|TWO_SIDED|95.0|0.83|1.27||2 sided|Log Rank|||Statistical analysis of number of deaths||1.27|0.83|0.811
91601884|NCT02551159|183095781|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.624|TWO_SIDED|95.0|0.87|1.25|||Log Rank|||Statistical analysis of number of deaths||1.25|0.87|0.624
91601885|NCT02551159|183095784|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.006|TWO_SIDED|95.0|1.1|1.68||2 sided|Log Rank|||||1.68|1.10|0.006
91601886|NCT02551159|183095784|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.008|TWO_SIDED|95.0|1.06|1.53||2 sided|Log Rank|||||1.53|1.06|0.008
91601887|NCT02551159|183095785|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.33||2 sided|Regression, Logistic|||||0.33|0.13|<0.001
91601888|NCT02551159|183095785|SUPERIORITY||Odds Ratio (OR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41||2 sided|Regression, Logistic|||||0.41|0.20|<0.001
91601889|NCT01913483|183095799|SUPERIORITY|||||||0.9458||||||The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.|Chi-squared|||Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O'Brien-Fleming alpha spending function.||||0.9458
91601890|NCT00535925|183095802|OTHER||Cox Proportional Hazard|0.48|||<|0.05|TWO_SIDED||||||Regression, Cox|Cox Shared Frailty Model, adjusted for age, sex, SBP, Hb, eGFR, albuminuria, HbA1c, total cholesterol, triglycerides (log-scaled) to reduce bias risk.||||||<0.05
91601891|NCT01116544|183095863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|TWO_SIDED|||||A priori threshold = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.005
91601892|NCT01116544|183095864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.|||||<|0.001||||||Hypothesis: significant increase in score (post-tx - pre-tx) for both groups|ANCOVA|FMA scores adjusted for baseline differences.||||||<0.001
91601893|NCT01116544|183095865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Across both groups, whether score increased following completion of intervention|ANCOVA|||||||0.001
91601894|NCT01116544|183095866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Across both treatment groups|ANCOVA|||||||0.001
91601895|NCT01116544|183095867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data combined between 2 treatment groups||||0.001
91601896|NCT01116544|183095868|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Both treatment groups combined||||>0.05
91650343|NCT02868281|183193190|OTHER||Difference in Least Squares Mean|0.3||||0.059|TWO_SIDED|95.0|0.0|0.6|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline AQLQ(S) score, type of Baseline controller, gender and age, with the center as a random factor.|||0.6|-0.0|0.059
91601897|NCT02419508|183095889|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
91601898|NCT02419508|183095890|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91601899|NCT02419508|183095891|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91601900|NCT02419508|183095892|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91601901|NCT02419508|183095893|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91601902|NCT02419508|183095894|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91601903|NCT02419508|183095895|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91601904|NCT01332071|183095896|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.58|||||TWO_SIDED|90.0|93.44|99.83|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.83|93.44|
91601905|NCT01332071|183095897|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.76|||||TWO_SIDED|90.0|93.25|102.5|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.50|93.25|
91601906|NCT01332071|183095898|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.47|||||TWO_SIDED|90.0|93.32|99.72|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.72|93.32|
91650344|NCT02868281|183193191|OTHER||Hazard Ratio (HR)|1.843||||0.01|TWO_SIDED|95.0|1.16|2.926|||Cox proportional hazards model||The model included treatment, Baseline ACT total score, center, type of Baseline controller, gender and age as covariates.|||2.926|1.160|0.010
91785879|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.49|||<|0.001|TWO_SIDED|95.0|-14.72|-4.26|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 44||-4.26|-14.72|<0.001
91785880|NCT01578850|183452419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-14.6|-3.99|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 52||-3.99|-14.60|<0.001
91785881|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.22||||0.014|TWO_SIDED|95.0|-9.39|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 28||-1.05|-9.39|0.014
91785882|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27||||0.011|TWO_SIDED|95.0|-11.09|-1.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 36||-1.46|-11.09|0.011
91785883|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-12.06|-3.44|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 44||-3.44|-12.06|<0.001
91601907|NCT01332071|183095899|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|95.79|||||TWO_SIDED|90.0|91.67|100.1|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||100.10|91.67|
91601908|NCT01332071|183095900|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|94.86|||||TWO_SIDED|90.0|90.7|99.22|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.22|90.70|
91601909|NCT01332071|183095901|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.88|||||TWO_SIDED|90.0|93.15|102.86|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.86|93.15|
91601910|NCT01738971|183095905|SUPERIORITY_OR_OTHER||relative probability|3.13|||<|0.001||95.0|1.9|5.13|||t-test, 2 sided|see above description of analysis taking into account cluster randomisation||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control."||5.13|1.90|<0.001
91601911|NCT01738971|183095905|SUPERIORITY_OR_OTHER||relative probability|2.57||||0.006||95.0|1.55|4.27||see above comments regarding analysis taking cluster randomised account into consideration|t-test, 2 sided|||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control."||4.27|1.55|0.006
91601912|NCT01542307|183095964|SUPERIORITY_OR_OTHER|||||||0.674|||||||Wilcoxon (Mann-Whitney)|||||||0.674
91601913|NCT01542307|183095965|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91601914|NCT01542307|183095966|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91601915|NCT01542307|183095967|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
91601916|NCT01542307|183095968|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
91601917|NCT01542307|183095969|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
91601918|NCT01542307|183095970|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91601919|NCT01542307|183095971|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
91601920|NCT00947531|183095982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17|||<|0.0001|TWO_SIDED|95.0|-8.22|-4.13||P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).|ANCOVA|The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.||The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation \[SD\] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).||-4.13|-8.22|< 0.0001
91601921|NCT01773421|183095995|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric Least Square (LS) Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.15||||||||1.15|0.97|
91601922|NCT01773421|183095996|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.2|1.02|
91650345|NCT02868281|183193192|OTHER||Rate Ratio|1.09||||0.897|TWO_SIDED|95.0|0.32|3.73|||Generalised linear model||The model included treatment, Baseline ACT total score, type of Baseline controller, gender and age as covariates.|||3.73|0.32|0.897
91709470|NCT00727090|183311547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.05|||||||t-test, 2 sided|||Null Hypothesis: Change in serum sodium from baseline is not different between groups||||<0.05
91709471|NCT01037816|183311555|SUPERIORITY|||||||0.137|||||||ANCOVA|||The treatment effect of the FS-67 patch was estimated by computing the difference in LS means of the FS-67 and placebo patches from the ANCOVA model||||0.137
91709472|NCT01037816|183311556|SUPERIORITY|||||||0.044|||||||ANCOVA|||||||0.044
91709473|NCT04378569|183311569|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5788|TWO_SIDED|95.0|0.49|2.53|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.53|0.49|0.5788
91601923|NCT01773421|183095997|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.0|1.27||||||||1.27|1|
91601924|NCT02804763|183096032|SUPERIORITY||||||=|0.0727||||||The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.|MCP-Mod|||"Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo.~The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect."||||=0.0727
91601925|NCT02804763|183096033|SUPERIORITY||Odds Ratio (OR)|1.6|||=|0.2699|TWO_SIDED|95.0|0.7|3.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||3.8|0.7|=0.2699
91601926|NCT02804763|183096033|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.1036|TWO_SIDED|95.0|0.9|4.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.8|0.9|=0.1036
91601927|NCT02804763|183096033|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.1518|TWO_SIDED|95.0|0.8|4.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.3|0.8|=0.1518
91613683|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.36|1.63||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - After sex, there is something you can do to prevent pregnancy||1.63|0.36|0.49
91613684|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|0.73||||0.31|TWO_SIDED|95.0|0.39|1.34||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - EC can prevent pregnancy after sex||1.34|0.39|0.31
91613685|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.33||||0.08|TWO_SIDED|95.0|0.96|1.84||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pill does not affect fertility||1.84|0.96|0.08
91785884|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16||||0.001|TWO_SIDED|95.0|-11.48|-2.85|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 52||-2.85|-11.48|0.001
91785885|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.86|||<|0.001|TWO_SIDED|95.0|-9.23|-2.49|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 28||-2.49|-9.23|<0.001
91785886|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.69|||<|0.001|TWO_SIDED|95.0|-12.33|-5.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 36||-5.05|-12.33|<0.001
91785887|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|||<|0.001|TWO_SIDED|95.0|-11.38|-3.8|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 44||-3.80|-11.38|<0.001
91613686|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.2|2.26||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.||Comparison of correct knowledge - patch does not affect fertility|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|2.26|1.2|0.002
91613687|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.23|2.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - ring does not affect fertility||2.35|1.23|0.002
91785888|NCT01578850|183452421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.32|||<|0.001|TWO_SIDED|95.0|-10.03|-2.6|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 52||-2.60|-10.03|<0.001
91601928|NCT02804763|183096033|SUPERIORITY||Difference vs PBO|11.6|||||TWO_SIDED|95.0|-9.2|32.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.4|-9.2|
91601929|NCT02804763|183096033|SUPERIORITY||Difference vs PBO|17.3|||||TWO_SIDED|95.0|-3.3|38.0||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.0|-3.3|
91785889|NCT03508908|183452432|OTHER||US dollars per DALY averted|3098.0|||||TWO_SIDED||||||||Cost (in US dollars) per DALY averted (Intervention referenced to Observation)|Cost (in US dollars) per DALY averted (Intervention referenced to Observation)||||
91785890|NCT00329524|183452434|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis based on paired t-test.|||||<|0.05||95.0|||||t-test, 2 sided|||||||<.05
91785891|NCT00329524|183452435|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||test for order effect|||||||.05
91785892|NCT01001325|183452436|SUPERIORITY_OR_OTHER|||||||0.685||95.0|||||Fisher Exact|||"Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.~Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%"||||0.685
91785893|NCT02758184|183452437|OTHER||Mean Difference (Final Values)|1031.2|STANDARD_ERROR_OF_MEAN|681.7||0.15|TWO_SIDED||||||ANOVA|||||||0.15
91785894|NCT01584440|183452451|SUPERIORITY||Ordinary Least Squares (OLS) Z-statistic|-1.5|||<=|0.001|TWO_SIDED||||||ANCOVA|Sequential Parallel Comparison Design (SPCD): data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
91785895|NCT01584440|183452451|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.5|||||TWO_SIDED||||||||Day 36|||||
91785896|NCT01584440|183452451|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.59|||||TWO_SIDED||||||||Day 70|||||
91785897|NCT01584440|183452453|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
91785898|NCT01584440|183452453|SUPERIORITY||ANCOVA Least Squares Mean Difference|-4.2|||||TWO_SIDED||||||||||Day 36|||
91785899|NCT01584440|183452453|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.78|||||TWO_SIDED||||||||Day 70|||||
91785900|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|0.77||||0.444|TWO_SIDED||||||ANCOVA|Delusions Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.444
91785901|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.27|||||TWO_SIDED||||||||Delusions Domain; Day 36|||||
91785902|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.78|||||TWO_SIDED||||||||Delusions Domain; Day 70|||||
91785903|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-0.18||||0.861|TWO_SIDED||||||ANCOVA|Hallucinations Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.861
91785904|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.29|||||TWO_SIDED||||||||Hallucinations Domain; Day 36|||||
91785905|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.22|||||TWO_SIDED||||||||Hallucinations Domain; Day 70|||||
91785906|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-0.32||||0.749|TWO_SIDED||||||ANCOVA|Depression/Dysphoria Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.749
91785907|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 36|||||
91785908|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.1|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 70|||||
91785909|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-0.81||||0.416|TWO_SIDED||||||ANCOVA|Anxiety Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.416
91785910|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Anxiety Domain; Day 36|||||
91785911|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.81|||||TWO_SIDED||||||||Anxiety Domain|||||
91785912|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-1.07||||0.287|TWO_SIDED||||||ANCOVA|Euphoria/Elation Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.287
91785913|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.04|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 36|||||
91785914|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.34|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 70|||||
91785915|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-1.31||||0.191|TWO_SIDED||||||ANCOVA|Apathy/Indifference Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.191
91785916|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
91785917|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.77|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
91785918|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-1.1||||0.271|TWO_SIDED||||||ANCOVA|Disinhibition Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.271
91785919|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.22|||||TWO_SIDED||||||||Disinhibition Domain; Day 36|||||
91785920|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.37|||||TWO_SIDED||||||||Disinhibition Domain; Day 70|||||
91785921|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-2.18||||0.029|TWO_SIDED||||||ANCOVA|Irritability/Lability Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.029
91785922|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.7|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 36|||||
91601930|NCT02804763|183096033|SUPERIORITY||Difference vs PBO|15.0|||||TWO_SIDED|95.0|-5.5|35.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.4|-5.5|
91601931|NCT02804763|183096033|SUPERIORITY||LS Mean Difference vs PBO|11.9|||||TWO_SIDED|95.0|-8.7|32.5||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.5|-8.7|
91601932|NCT02804763|183096033|SUPERIORITY||LS Mean Difference vs PBO|17.6|||||TWO_SIDED|95.0|-3.2|38.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.3|-3.2|
91601933|NCT02804763|183096033|SUPERIORITY||LS Mean Difference vs PBO|15.2|||||TWO_SIDED|95.0|-5.2|35.6||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.6|-5.2|
91601934|NCT00445302|183096090|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|87.09|||||TWO_SIDED|90.0|63.59|119.26||||||||119.26|63.59|
91601935|NCT00445302|183096090|SUPERIORITY_OR_OTHER||Ratio of least squares means(%)|106.6||||||90.0|78.99|143.87||||||||143.87|78.99|
91601936|NCT00445302|183096090|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|106.76||||||90.0|79.11|144.08||||||||144.08|79.11|
91601937|NCT00445302|183096093|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|121.74||||||90.0|91.86|161.43||||||||161.43|91.86|
91601938|NCT00445302|183096093|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|151.44||||||90.0|115.78|198.09||||||||198.09|115.78|
91601939|NCT00445302|183096093|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|169.51||||||90.0|129.59|221.72||||||||221.72|129.59|
91650346|NCT01335464|183193193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|125.26|STANDARD_ERROR_OF_MEAN|24.209|<|0.0001|TWO_SIDED|95.0|77.68|172.84||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix~Nintedanib 150 mg bid versus Placebo"|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||172.84|77.68|<0.0001
91785923|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.93|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 70|||||
91785924|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-2.21||||0.027|TWO_SIDED||||||ANCOVA|Aberrant Motor Behavior Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.027
91601940|NCT01400932|183096095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.2|-15.8|||ANCOVA|||||-15.8|-26.2|<0.001
91601941|NCT01400932|183096096|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
91601942|NCT01400932|183096096|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
91785925|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.38|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 36|||||
91785926|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.22|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 70|||||
91522788|NCT03243422|182920808|SUPERIORITY||Slope|0.079||||0.15|TWO_SIDED|95.0|-0.029|0.187||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.187|-0.029|0.15
91601943|NCT01400932|183096096|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
91601944|NCT01400932|183096096|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
91601945|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
91601946|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
91601947|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
91601948|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
91601949|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
91601950|NCT01400932|183096097|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Week 1; NIL|ANCOVA|||||||0.007
91601951|NCT01400932|183096097|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Week 2; NIL|ANCOVA|||||||0.008
91785927|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-1.09||||0.274|TWO_SIDED||||||ANCOVA|Sleep/Nighttime Behavior Disorders Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.274
91785928|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.57|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 36|||||
91522789|NCT03243422|182920809|SUPERIORITY||Slope|-0.02||||0.69|TWO_SIDED|95.0|-0.118|0.078||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.078|-0.118|0.69
91601952|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
91601953|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
91601954|NCT01400932|183096097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
91601955|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; Total|ANCOVA|||||||<0.001
91601956|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; Total|ANCOVA|||||||<0.001
91601957|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; Total|ANCOVA|||||||<0.001
91601958|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; Total|ANCOVA|||||||<0.001
91601959|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; Total|ANCOVA|||||||<0.001
91601960|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
91601961|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
91601962|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
91601963|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
91601964|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
91601965|NCT01400932|183096098|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Week 1; NIL|ANCOVA|||||||0.002
91601966|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; NIL|ANCOVA|||||||<0.001
91601967|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
91785929|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.08|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 70|||||
91785930|NCT01584440|183452454|SUPERIORITY||OLS Z-statistic|-0.65||||0.513|TWO_SIDED||||||ANCOVA|Appetite/Eating Changes Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.513
91785931|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 36|||||
91601968|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
91601969|NCT01400932|183096098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
91601970|NCT01400932|183096099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91601971|NCT01400932|183096100|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Week 1|ANCOVA|||||||0.174
91601972|NCT01400932|183096100|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Week 2|ANCOVA|||||||0.013
91601973|NCT01400932|183096100|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 4|ANCOVA|||||||0.001
91601974|NCT01400932|183096100|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 8|ANCOVA|||||||0.001
91601975|NCT01400932|183096100|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
91601976|NCT01400932|183096101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
91601977|NCT01400932|183096101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
91601978|NCT01400932|183096101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
91601979|NCT01400932|183096101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
91601980|NCT01400932|183096101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
91601981|NCT03657459|183096132|SUPERIORITY|||||||0.0096|||||||Chi-squared|Pearsons Chi Square||||||0.0096
91601982|NCT03657459|183096133|SUPERIORITY|||||||0.9||||||no adjustment|Chi-squared|Pearson Chi-square||||||0.90
91613688|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.62|1.43||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Depo does affect fertility||1.43|0.62|0.77
91601983|NCT00927368|183096242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-0.16|||<|0.001|TWO_SIDED|95.0|-0.61|0.29||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.29|-0.61|< 0.001
91601984|NCT00927368|183096242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.16||||0.03|TWO_SIDED|95.0|-0.29|0.61||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.61|-0.29|0.03
91601985|NCT00927368|183096242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.57|0.33||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.33|-0.57|< 0.001
91601986|NCT00927368|183096242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).|Mean Difference (Final Values)|0.12||||0.02|TWO_SIDED|95.0|-0.33|0.57||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.57|-0.33|0.02
91650347|NCT01335464|183193194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.248||0.9657|TWO_SIDED|95.0|-2.5|2.4|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||2.40|-2.50|0.9657
91650348|NCT01335464|183193195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6728|TWO_SIDED|95.0|0.54|2.42|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard Ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||2.42|0.54|0.6728
91650349|NCT01335464|183193196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.93|STANDARD_ERROR_OF_MEAN|19.708|<|0.0001|TWO_SIDED|95.0|71.27|148.59|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.59|71.27|<0.0001
91650350|NCT01335464|183193197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.54|5.5|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.50|2.54|<0.0001
91650351|NCT01335464|183193198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|2.11|4.33|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.33|2.11|<0.0001
91709474|NCT04378569|183311569|SUPERIORITY||Odds Ratio (OR)|0.84||||0.6488|TWO_SIDED|95.0|0.33|2.17|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.17|0.33|0.6488
91709475|NCT04378569|183311569|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5653|TWO_SIDED|95.0|0.32|2.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.25|0.32|0.5653
91785932|NCT01584440|183452454|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.24|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 70|||||
91709476|NCT04378569|183311570|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5033|TWO_SIDED|95.0|0.25|2.78|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.78|0.25|0.5033
91785933|NCT01584440|183452455|SUPERIORITY||OLS Z-statistic|-3.53|||<=|0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
91785934|NCT01584440|183452455|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.01|||||TWO_SIDED||||||||Day 36|||||
91785935|NCT01584440|183452455|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.49|||||TWO_SIDED||||||||Day 70|||||
91785936|NCT01584440|183452456|SUPERIORITY||OLS Z-statistic|-3.34||||0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.001
91522790|NCT03243422|182920810|SUPERIORITY||Slope|0.017||||0.7|TWO_SIDED|95.0|-0.07|0.104||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.104|-0.070|0.70
91709477|NCT04378569|183311570|SUPERIORITY||Odds Ratio (OR)|0.83||||0.4975|TWO_SIDED|95.0|0.25|2.79|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.79|0.25|0.4975
91601987|NCT00927368|183096242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.72|0.16||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.16|-0.72|< 0.001
91601988|NCT00927368|183096242|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.28||||0.11|TWO_SIDED|95.0|-0.16|0.72||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.72|-0.16|0.11
91785937|NCT01584440|183452456|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.41|||||TWO_SIDED||||||||Day 36|||||
91785938|NCT01584440|183452456|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.94|||||TWO_SIDED||||||||Day 70|||||
91785939|NCT01584440|183452457|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
91785940|NCT01584440|183452457|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.65|||||TWO_SIDED||||||||Day 36|||||
91601989|NCT00927368|183096243|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|5.0||||0.04|TWO_SIDED|95.0|-17.0|34.0||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||34|-17|0.04
91601990|NCT00927368|183096243|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-5.0||||0.002|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.002
91601991|NCT00927368|183096243|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|3.0||||0.03|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.03
91709478|NCT04378569|183311570|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||P value was not evaluable|Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.55|0.04|
91785941|NCT01584440|183452457|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.01|||||TWO_SIDED||||||||||Day 70|||
91785942|NCT01584440|183452458|SUPERIORITY||OLS Z-statistic|-2.57||||0.01|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.010
91785943|NCT01584440|183452458|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.68|||||TWO_SIDED||||||||Day 36|||||
91785944|NCT01584440|183452458|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.2|||||TWO_SIDED||||||||Day 70|||||
91785945|NCT01584440|183452459|SUPERIORITY||OLS Z-statistic|-3.08||||0.002|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.002
91785946|NCT01584440|183452459|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.56|||||TWO_SIDED||||||||Day 36|||||
91785947|NCT01584440|183452459|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.9|||||TWO_SIDED||||||||Day 70|||||
91785948|NCT01584440|183452460|SUPERIORITY||OLS Z-statistic|-2.66||||0.008|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.008
91785949|NCT01584440|183452460|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.43|||||TWO_SIDED||||||||Day 36|||||
91785950|NCT01584440|183452460|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.75|||||TWO_SIDED||||||||Day 70|||||
91785951|NCT01584440|183452461|SUPERIORITY||OLS Z-statistic|-1.96||||0.05|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.050
91785952|NCT01584440|183452461|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.62|||||TWO_SIDED||||||||Day 36|||||
91785953|NCT01584440|183452461|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.3|||||TWO_SIDED||||||||Day 70|||||
91785954|NCT01584440|183452462|SUPERIORITY||OLS Z-statistic|-2.33||||0.02|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.020
91785955|NCT01584440|183452462|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.57|||||TWO_SIDED||||||||Day 36|||||
91785956|NCT01584440|183452462|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.18|||||TWO_SIDED||||||||Day 70|||||
91785957|NCT01584440|183452463|SUPERIORITY||OLS Z-statistic|1.94||||0.053|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.053
91601992|NCT00927368|183096243|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-3.0||||0.005|TWO_SIDED|95.0|-24.0|23.0||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||23|-24|0.005
91613689|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.61||||0.002|TWO_SIDED|95.0|1.19|2.17||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Hormonal IUD does not affect fertility||2.17|1.19|0.002
91613690|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.56||||0.004|TWO_SIDED|95.0|1.15|2.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Non-hormonal IUD does not affect fertility||2.1|1.15|0.004
91785958|NCT01584440|183452463|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.52|||||TWO_SIDED||||||||Day 36|||||
91785959|NCT01584440|183452463|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.84|||||TWO_SIDED||||||||Day 70|||||
91785960|NCT01584440|183452464|SUPERIORITY||OLS Z-statistic|-0.72||||0.469|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Caregiver|||||0.469
91785961|NCT01584440|183452464|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Caregiver: Day 36|||||
91785962|NCT01584440|183452464|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.06|||||TWO_SIDED||||||||Caregiver: Day 70|||||
91785963|NCT01584440|183452464|SUPERIORITY||OLS Z-statistic|1.41||||0.159|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Participant|||||0.159
91785964|NCT01584440|183452464|SUPERIORITY||ANCOVA Least Squares Mean Difference|1.09|||||TWO_SIDED||||||||Participant: Day 36|||||
91785965|NCT01584440|183452464|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.7|||||TWO_SIDED||||||||Participant: Day 70|||||
91785966|NCT01584440|183452465|SUPERIORITY||OLS Z-statistic|-1.4||||0.163|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.163
91785967|NCT01584440|183452465|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Day 36|||||
91785968|NCT01584440|183452465|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.39|||||TWO_SIDED||||||||Day 70|||||
91785969|NCT01584440|183452466|SUPERIORITY||OLS Z-statistic|-1.08||||0.279|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.279
91785970|NCT01584440|183452466|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.76|||||TWO_SIDED||||||||Day 8|||||
91785971|NCT01584440|183452466|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.02|||||TWO_SIDED||||||||Day 22|||||
91785972|NCT01584440|183452466|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.74|||||TWO_SIDED||||||||Day 43|||||
91785973|NCT01584440|183452466|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.05|||||TWO_SIDED||||||||Day 57|||||
91785974|NCT01584440|183452467|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0001|TWO_SIDED|95.0|1.62|4.5|||ANCOVA||Day 36|||4.50|1.62|0.0001
91785975|NCT01584440|183452467|SUPERIORITY||Odds Ratio (OR)|1.61||||0.2184|TWO_SIDED|95.0|0.75|3.43|||ANCOVA||Day 70|||3.43|0.75|0.2184
91785976|NCT01584440|183452468|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0266|TWO_SIDED|95.0|1.11|5.42|||ANCOVA|||||5.42|1.11|0.0266
91785977|NCT01584440|183452469|SUPERIORITY||Odds Ratio (OR)|2.16||||0.002|TWO_SIDED|95.0|1.31|3.55|||ANCOVA||Day 36|||3.55|1.31|0.002
91785978|NCT01584440|183452469|SUPERIORITY||Odds Ratio (OR)|2.32||||0.031|TWO_SIDED|95.0|1.08|5.0|||ANCOVA||Day 70|||5.00|1.08|0.031
91785979|NCT01584440|183452470|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0048|TWO_SIDED|95.0|1.31|4.46|||ANCOVA|||||4.46|1.31|0.0048
91785980|NCT00531427|183452489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0853|TWO_SIDED|95.0|-0.8|0.05|||Mixed Models Analysis|Statistics are based on a mixed effect general linear model||"\[Week 12 analysis\] The null hypothesis was no group differences. The alternative hypothesis was that BTDS arm was superior to the placebo arm.~Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)."||0.05|-0.80|0.0853
91785981|NCT00531427|183452490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.7098|TWO_SIDED|95.0|-0.233|0.159||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|ANCOVA|with treatment as a factor and screening and pre-randomization mean pain as covariates.||Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took \<=1 dose of supplemental analgesia||0.159|-0.233|0.7098
91785982|NCT00531427|183452491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46||||0.0034|TWO_SIDED|95.0|-7.44|-1.48||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|Mixed Models Analysis|||Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.||-1.48|-7.44|0.0034
91785983|NCT05477108|183452492|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 42.91. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1028 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|104.24|||||TWO_SIDED|90.0|95.78|113.44|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||113.44|95.78|
91601993|NCT00927368|183096243|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-2.0||||0.006|TWO_SIDED|95.0|-22.0|25.0||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||25|-22|0.006
91601994|NCT00927368|183096243|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|2.0||||0.02|TWO_SIDED|95.0|-20.0|29.0||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||29|-20|0.02
91601995|NCT00927368|183096244|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||Stimulating needle versus stimulating catheter.||||0.11
91601996|NCT00927368|183096244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.0||||0.01|TWO_SIDED|95.0|6.0|75.0|||ANOVA|||Stimulating needle versus ultrasound guidance alone||75|6|0.01
91601997|NCT00927368|183096244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.0|||<|0.001|TWO_SIDED|95.0|31.0|102.0|||ANOVA|||Stimulating catheter versus ultrasound guidance alone||102|31|< 0.001
91601998|NCT00927368|183096245|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|14.0|||||TWO_SIDED||||||||Incremental cost (additional cost of stimulating needle compared to ultrasound alone).|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
91601999|NCT00927368|183096245|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|36.0|||||TWO_SIDED||||||||We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
91602000|NCT00927368|183096245|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|50.0|||||TWO_SIDED||||||||We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
91602001|NCT00964431|183096251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.545|STANDARD_ERROR_OF_MEAN|1.8912|<|0.001|TWO_SIDED|95.0|5.816|13.275|||ANCOVA|||||13.275|5.816|<0.001
91602002|NCT01482910|183096283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|||<|0.0001|TWO_SIDED|95.0|6.8|13.4||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|ANCOVA|ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (\<45 letters vs ≥45 letters) as fixed factors|Least square mean difference (EYLEA-PDT) was estimated from ANCOVA, where a positive value is in favor of EYLEA.|Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.||13.4|6.8|<0.0001
91602003|NCT01482910|183096284|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.0359|TWO_SIDED|95.0|0.4|12.9||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|Cochran-Mantel-Haenszel|CMH adjusted for baseline BCVA group (\<45 letters vs ≥45 letters)|Proportion difference (EYLEA-PDT) was estimated from CMH, where a positive value is in favor of EYLEA.|Null hypothesis: proportions are identical in both groups||12.9|0.4|0.0359
91602004|NCT01058096|183096316|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.3||||0.0004|TWO_SIDED|95.0|-6.7|-1.9|||Mixed Models Analysis||cariprazine - placebo|||-1.9|-6.7|0.0004
91602005|NCT01058096|183096317|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4||||0.0027|TWO_SIDED|95.0|-0.7|-0.1|||MMRM analysis||cariprazine - placebo|||-0.1|-0.7|0.0027
91602006|NCT05099640|183096324|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||||-328.66|-463.07|<0.0001
91602007|NCT05099640|183096325|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||||-54.35|-74.09|<0.0001
91602008|NCT05099640|183096326|OTHER||Odds Ratio (OR)|30.33|||<|0.0001|TWO_SIDED|95.0|5.3|294.24|||Chi-squared|||||294.24|5.30|<0.0001
91602009|NCT05099640|183096327|OTHER||Odds Ratio (OR)|51.54|||<|0.0001|TWO_SIDED|95.0|12.28|245.34|||Chi-squared|||||245.34|12.28|<0.0001
91602010|NCT05099640|183096328|OTHER||LS Mean Difference|-289.89|STANDARD_ERROR_OF_MEAN|33.44|<|0.0001|TWO_SIDED|95.0|-356.29|-223.5|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-223.50|-356.29|<0.0001
91602011|NCT05099640|183096328|OTHER||LS Mean Difference|-375.47|STANDARD_ERROR_OF_MEAN|30.424|<|0.0001|TWO_SIDED|95.0|-435.88|-315.06|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-315.06|-435.88|<0.0001
91602012|NCT05099640|183096328|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-328.66|-463.07|<0.0001
91602013|NCT05099640|183096329|OTHER||LS Mean Difference|-42.52|STANDARD_ERROR_OF_MEAN|6.008|<|0.0001|TWO_SIDED|95.0|-54.45|-30.59|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-30.59|-54.45|<0.0001
91602014|NCT05099640|183096329|OTHER||LS Mean Difference|-61.03|STANDARD_ERROR_OF_MEAN|4.531|<|0.0001|TWO_SIDED|95.0|-70.02|-52.03|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-52.03|-70.02|<0.0001
91602015|NCT05099640|183096329|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-54.35|-74.09|<0.0001
91602016|NCT05099640|183096334|OTHER||LS Mean Difference|-492.23|STANDARD_ERROR_OF_MEAN|55.588|<|0.0001|TWO_SIDED|95.0|-614.59|-369.87|||Mixed Models Analysis|||||-369.87|-614.59|<0.0001
91602017|NCT05099640|183096335|OTHER||LS Mean Difference|-74.73|STANDARD_ERROR_OF_MEAN|10.436|<|0.0001|TWO_SIDED|95.0|-97.72|-51.74|||Mixed Models Analysis|||||-51.74|-97.72|<0.0001
91602018|NCT01552681|183096350|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.|ANCOVA|||Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.||||0.33
91602019|NCT00236080|183096373|NON_INFERIORITY_OR_EQUIVALENCE|Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.||||||0.1236||||||The p-value of Overall Treatment to Placebo|ANCOVA|This analysis adjusted for the difference among the treatment groups at baseline.||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.||||0.1236
91602020|NCT00236080|183096374|NON_INFERIORITY_OR_EQUIVALENCE|Using the adjusted p value from Tukey's least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.||||||0.0945||||||The p-value of Overall Treatment to Placebo|ANCOVA|||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .||||0.0945
91602021|NCT01214044|183096375|OTHER|A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.||||||0.2||||||A priori threshold for significance was p = 0.05.|t-test, 2 sided|paired t-test||A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).||||0.2
91602022|NCT01214044|183096376|OTHER|A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.||||||0.01||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.~A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.01
91602023|NCT01214044|183096377|OTHER|A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.||||||0.14||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.~A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.14
91650352|NCT01335464|183193199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.52|5.48|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.48|2.52|<0.0001
91650353|NCT01335464|183193202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.0007|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.79|1.32|0.0007
91650354|NCT01335464|183193203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.847||||0.001|TWO_SIDED|95.0|1.28|2.66|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.66|1.28|0.0010
91522791|NCT03243422|182920811|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.59|TWO_SIDED|95.0|0.61|1.33||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Regression, Cox|Discrete-time interval model||||1.33|0.61|0.59
91785984|NCT05477108|183452492|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.85. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0831 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.45|||||TWO_SIDED|90.0|84.31|103.58|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||103.58|84.31|
91785985|NCT05477108|183452492|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.66. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0971 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|100.14|||||TWO_SIDED|90.0|91.9|109.11|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||109.11|91.90|
91522792|NCT03243422|182920812|SUPERIORITY||Slope|0.191||||0.027|TWO_SIDED|95.0|0.022|0.36|||Mixed Models Analysis|||Analysis was restricted to ARIC participants who were enrolled in ACHIEVE||0.360|0.022|0.027
91602024|NCT01214044|183096378|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.06||||||Spearman's rho (rs) = 0.66|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.06
91602025|NCT01214044|183096378|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.48||||||Spearman's rho (rs) = 0.02|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.48
91602026|NCT04698525|183096379|NON_INFERIORITY|"A new treatment (memantine) that is not much worse or non-inferior to the standard treatment (valproate) may be attractive if, compared to it, it is expected to cause fewer side effects or improve quality of life or if its dosing regimen is easier to tolerate."|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|14.0||0.9|TWO_SIDED|95.0|0.0|10.0||"Comparison between VPA and Memantine was:~0.9 p-value (two-tailed)"|Wilcoxon (Mann-Whitney)|"Memantine 3.534 z corrected for ties 0.0004 p-value (two-tailed)~VPA 3.418 z corrected for ties 0.0006 p-value (two-tailed)"||Null hypothesis: Memantine is as effective as valproate in treating episodic migraine.|We made also student t|10|0|0.9
91602027|NCT02211261|183096427|OTHER||Percentage of Test relative to Reference|17.66|||||TWO_SIDED|90.0|8.44|36.95|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||36.95|8.44|
91602028|NCT02211261|183096427|OTHER||Percentage of Test relative to Reference|32.73|||||TWO_SIDED|90.0|21.64|49.51|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||49.51|21.64|
91602029|NCT02211261|183096427|OTHER||Percentage of Test relative to Reference|35.02|||||TWO_SIDED|90.0|23.6|51.95|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||51.95|23.60|
91602030|NCT02211261|183096427|OTHER||Percentage of Test relative to Reference|53.18|||||TWO_SIDED|90.0|36.36|77.78|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.78|36.36|
91602031|NCT02211261|183096429|OTHER||Percentage of Test relative to Reference|7.32|||||TWO_SIDED|90.0|4.7|11.4|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||11.40|4.70|
91785986|NCT05477108|183452492|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 42.66. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 73.29% to 136.44% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|103.12|||||TWO_SIDED|90.0|94.44|112.6|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||112.60|94.44|
91522793|NCT03243422|182920813|SUPERIORITY||Slope|-0.061||||0.18|TWO_SIDED|95.0|-0.151|0.028|||Mixed Models Analysis|||||0.028|-0.151|0.18
91522794|NCT01083654|182920827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.262|TWO_SIDED|95.0|0.2|1.55|||Regression, Logistic|||||1.55|0.20|.262
91522795|NCT03525548|182920854|SUPERIORITY||Least squares (LS) mean difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.6|||Mixed-effects model for repeated measure|||||12.6|7.4|<0.0001
91522796|NCT03525548|182920855|SUPERIORITY||LS mean difference|-45.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-40.1|||Mixed-effects model for repeated measure|||||-40.1|-50.1|<0.0001
91602032|NCT02211261|183096429|OTHER||Percentage of Test relative to Reference|32.19|||||TWO_SIDED|90.0|20.67|50.12|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||50.12|20.67|
91602033|NCT02211261|183096429|OTHER||Percentage of Test relative to Reference|34.43|||||TWO_SIDED|90.0|22.57|52.52|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||52.52|22.57|
91602034|NCT02211261|183096429|OTHER||Percentage of Test relative to Reference|51.47|||||TWO_SIDED|90.0|34.26|77.31|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.31|34.26|
91602035|NCT02175680|183096459|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum|The time to Virologic Failure for the subjects treated with PRO 140 monotherapy was compared to historical data.|||The median time to Virologic Failure for historical controls was 29 days.|||<0.0001
91602036|NCT04506294|183096516|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||.536
91602037|NCT00874250|183096561|SUPERIORITY_OR_OTHER||Proportion|0.98||||0.0024|TWO_SIDED|95.0|0.895|0.996|||Binomial Test|||||0.996|0.895|0.0024
91602038|NCT02986230|183096570|SUPERIORITY||Odds Ratio (OR)|1.07||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index for breast, cervical, and colorectal cancer. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
91613691|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|1.54||||0.005|TWO_SIDED|95.0|1.14|2.07||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Implant does not affect fertility||2.07|1.14|0.005
91650355|NCT01335464|183193204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4298|TWO_SIDED|95.0|0.55|1.29|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||1.29|0.55|0.4298
91709479|NCT04378569|183311571|SUPERIORITY||Odds Ratio (OR)|0.75||||0.7237|TWO_SIDED|95.0|0.23|2.44|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.44|0.23|0.7237
91602039|NCT02986230|183096570|SUPERIORITY||Odds Ratio (OR)|0.91||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index date for breast, cervical, and colorectal cancer. Model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in randomization process. Tests of the planned contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
91602040|NCT02986230|183096571|SUPERIORITY||Odds Ratio (OR)|1.04||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
91602041|NCT02986230|183096571|SUPERIORITY||Odds Ratio (OR)|0.71||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
91602042|NCT02986230|183096572|SUPERIORITY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of lung cancer screening by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
91602043|NCT02986230|183096572|SUPERIORITY||Odds Ratio (OR)|1.02||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the intervention effect on the completion of lung cancer screening by 12 months post-index. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
91602044|NCT01469000|183096573|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.009|TWO_SIDED|95.0|0.48|0.93||1-sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.93|0.48|0.009
91602045|NCT01469000|183096574|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.005|TWO_SIDED|95.0|0.46|0.9||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.90|0.46|0.005
91602046|NCT01469000|183096575|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.105|TWO_SIDED|95.0|0.51|1.16||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||1.16|0.51|0.105
91602047|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.77|1.78||||||Patient-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.78|0.77|
91602048|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.6|1.42||||||Patient-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.42|0.60|
91602049|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.84|2.3||||||Patient-rated Cough: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.30|0.84|
91602050|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.65|1.71||||||Patient-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.71|0.65|
91650356|NCT01335464|183193205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|1.744||0.1832|TWO_SIDED|95.0|-5.74|1.1|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.10|-5.74|0.1832
91650357|NCT01335464|183193206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.446||0.551|TWO_SIDED|95.0|-1.97|3.7|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ Impact component-by-visit and random effect for patient||3.70|-1.97|0.5510
91650358|NCT01335464|183193207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|1.427||0.4049|TWO_SIDED|95.0|-3.99|1.61|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||1.61|-3.99|0.4049
91785987|NCT05477108|183452492|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.75. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.24% to 134.70% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.39|||||TWO_SIDED|90.0|85.29|102.26|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||102.26|85.29|
91522797|NCT03525548|182920856|SUPERIORITY||LS mean difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.8|23.0|||Mixed-effects model for repeated measure|||||23.0|11.8|<0.0001
91650359|NCT01335464|183193208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.289||0.5446|TWO_SIDED|95.0|-3.31|1.75|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||1.75|-3.31|0.5446
91650360|NCT01335464|183193209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|1.77||0.6203|TWO_SIDED|95.0|-4.35|2.6|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||2.60|-4.35|0.6203
91650361|NCT01335464|183193210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|1.803||0.8942|TWO_SIDED|95.0|-3.78|3.3|||Mixed Models Analysis||"Within- patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||3.30|-3.78|0.8942
91709480|NCT04378569|183311571|SUPERIORITY||Odds Ratio (OR)|0.59||||0.838|TWO_SIDED|95.0|0.17|2.1|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.10|0.17|0.8380
91522798|NCT01226511|182920859|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.03|-1.27|||Mixed Models Analysis|||||-1.27|-4.03|<0.001
91522799|NCT02696564|182920873|SUPERIORITY|We will estimate a 95% confidence interval for the losartan vs placebo mean difference, using the regression estimate and the t-distribution; we will reject the null that losartan is equivalent to placebo if the 95% interval excludes 0.0.||||||0.133|||||||Mixed Models Analysis|P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.||||||0.133
91522800|NCT02696564|182920874|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.762||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.762
91522801|NCT02696564|182920875|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.834||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.834
91522802|NCT02696564|182920876|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.783||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.783
91522803|NCT02696564|182920877|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.053||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.053
91522804|NCT02696564|182920878|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.016||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.016
91522805|NCT02696564|182920879|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.065||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.065
91522806|NCT02696564|182920880|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.293||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.293
91522807|NCT02696564|182920881|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.356||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.356
91602051|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.32|1.02||||||Patient-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.02|0.32|
91602052|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.64|1.91||||||Patient-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.91|0.64|
91602053|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.68|1.77||||||Patient-rated Overall Symptoms: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.77|0.68|
91602054|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.88|2.17||||||Patient-rated Interference: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.17|0.88|
91522808|NCT02696564|182920882|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.009||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.009
91602055|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.72|1.74||||||Patient-rated Quality of Life: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.74|0.72|
91602056|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.97|2.49||||||Observer-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.49|0.97|
91709481|NCT04378569|183311571|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||p-value was unevaluable||Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.55|0.04|
91602057|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||Observer-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.93|0.82|
91602058|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.15||||||Observer-rated Cough:Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.15|0.72|
91602059|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.64|1.83||||||Observer-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.83|0.64|
91602060|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.6|2.91||||||Observer-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.91|0.60|
91602061|NCT01469000|183096579|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.41|1.03||||||Observer-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.03|0.41|
91602062|NCT02065453|183096611|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The data will be analyzed using linear regression, Kolmogorov-Smirnov test, and chi-square analysis.||||<0.001
91602063|NCT03694392|183096619|OTHER||Hazard Ratio (HR)|0.85|||<|0.05|TWO_SIDED|95.0|0.76|0.94||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.3% (5.9%, 23.8%)|||0.94|0.76|<0.05
91785988|NCT05477108|183452492|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.81. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.21% to 134.75% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|99.7|||||TWO_SIDED|90.0|91.44|108.71|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||108.71|91.44|
91602064|NCT03694392|183096620|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.65|1.09||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.9% (-9.2% to 35.2%)|||1.09|0.65|<0.05
91602065|NCT03694392|183096621|OTHER||Hazard Ratio (HR)|0.83|||<|0.05|TWO_SIDED|95.0|0.66|1.06||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 16.7% (-5.6% to 34.4%)|||1.06|0.66|<0.05
91602066|NCT03694392|183096622|OTHER||Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.08||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 2.4% (-8.1% to 11.9%)|||1.08|0.88|<0.05
91602067|NCT03694392|183096623|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.75|1.8|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -15.7% (-79.5% to 25.5%)|||1.80|0.75|<0.05
91602068|NCT03694392|183096624|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.95|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.0% to 5.4%)|||1.06|0.95|<0.05
91602069|NCT03694392|183096625|OTHER||Hazard Ratio (HR)|1.8|||<|0.05|TWO_SIDED|95.0|-2.2|5.5|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 1.8% (-2.2% to 5.5%)|||5.5|-2.2|<0.05
91785989|NCT05477108|183452493|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 34.29. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0593 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|100.35|115.72|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.72|100.35|
91785990|NCT05477108|183452493|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 86.08. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2925 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Ratio Mean (%)|112.22|||||TWO_SIDED|90.0|92.27|136.49|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||136.49|92.27|
91522809|NCT02696564|182920883|SUPERIORITY||Relative rate (losartan to placebo)|0.8||||0.892|TWO_SIDED|95.0|0.03|18.77|||Negative binomial model|||P-value for rate of mild exacerbations between treatment groups (measured in events per 100 person-years).||18.77|0.03|0.892
91522810|NCT02696564|182920883|SUPERIORITY||Relative rate (losartan to placebo)|0.91||||0.946|TWO_SIDED|95.0|0.05|14.97|||Negative binomial model|||P-value for rate of moderate exacerbations between treatment groups (measured in events per 100 person-years).||14.97|0.05|0.946
91785991|NCT05477108|183452493|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 47.07. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1250 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|101.45|||||TWO_SIDED|90.0|91.76|112.15|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||112.15|91.76|
91785992|NCT05477108|183452494|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 35.68. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0668 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|106.87|||||TWO_SIDED|90.0|99.3|115.01|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.01|99.30|
91785993|NCT05477108|183452494|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 74.17. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2735 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|102.02|||||TWO_SIDED|90.0|89.12|116.79|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||116.79|89.12|
91785994|NCT05477108|183452494|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 66.88. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2210 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|94.91|122.36|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||122.36|94.91|
91785995|NCT05477108|183452494|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean ratio (%)|106.1|||||TWO_SIDED|90.0|98.39|114.41|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||114.41|98.39|
91785996|NCT05477108|183452494|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|97.02|||||TWO_SIDED|90.0|84.18|111.82|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||111.82|84.18|
91602070|NCT03694392|183096626|OTHER||Hazard Ratio (HR)|9.4|||<|0.05|TWO_SIDED|95.0|-5.4|22.1|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 9.4% (-5.4% to 22.1%)|||22.1|-5.4|<0.05
91602071|NCT03694392|183096627|OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.86|1.02|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 6.2% (-2.2% to 13.9%)|||1.02|0.86|<0.05
91785997|NCT05477108|183452494|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|105.74|||||TWO_SIDED|90.0|92.59|120.75|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||120.75|92.59|
91785998|NCT01253577|183452502|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||McNemar|||||||0.0280
91602072|NCT03694392|183096628|OTHER||Hazard Ratio (HR)|1.07|||<|0.05|TWO_SIDED|95.0|0.75|1.52|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -6.9% (-51.6% to 24.6%)|||1.52|0.75|<0.05
91785999|NCT01253577|183452503|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Fisher Exact|||||||<0.0001
91786000|NCT01253577|183452504|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|95.0|||||McNemar|||||||0.0023
91786001|NCT05688670|183452505|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.001|TWO_SIDED|95.0|-0.59|-0.18|||t-test, 2 sided|||||-0.18|-0.59|0.001
91786002|NCT05688670|183452506|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.41|TWO_SIDED|95.0|-0.2|0.08|||t-test, 2 sided|||12-24 hour postoperative opioid use||0.08|-0.20|0.41
91786003|NCT05688670|183452506|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.14|TWO_SIDED|95.0|-0.37|0.06|||t-test, 2 sided|||24-48 hour postoperative opioid use||0.06|-0.37|0.14
91602073|NCT03694392|183096629|OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 5.2% (-18.8% to 24.4%)|||1.12|0.76|<0.05
91786004|NCT05688670|183452506|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.16|TWO_SIDED|95.0|-0.52|0.09|||t-test, 2 sided|||12-48 hours hours after surgery||0.09|-0.52|0.16
91602074|NCT03694392|183096630|OTHER||Hazard Ratio (HR)|0.89|||<|0.05|TWO_SIDED|95.0|0.85|0.93|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.8% (6.6% to 14.7%)|||0.93|0.85|<0.05
91602075|NCT03694392|183096631|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.94|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.2% to 5.6%)|||1.06|0.94|<0.05
91602076|NCT03694392|183096632|OTHER||Hazard Ratio (HR)|1.46|||<|0.05|TWO_SIDED|95.0|1.06|2.0|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -45.5% (-100.2% to -5.8%)|||2.00|1.06|<0.05
91602077|NCT03694392|183096633|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.82|0.99|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.2% (1.4% to 18.2%)|||0.99|0.82|<0.05
91602078|NCT03694392|183096634|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -16.2% (-43.0% to 5.5%)|||1.43|0.95|<0.05
91602079|NCT03694392|183096635|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.76|0.94|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.7% (6.0% to 24.5%)|||0.94|0.76|<0.05
91602080|NCT03694392|183096636|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.6|1.34|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.3% (-33.9% to 39.9%)|||1.34|0.60|<0.05
91602081|NCT05523973|183096643|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
91602082|NCT05523973|183096644|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91602083|NCT05523973|183096645|SUPERIORITY|||||||0.09|||||||Sign test|||||||0.09
91602084|NCT05523973|183096646|SUPERIORITY|||||||0.722|||||||Sign test|||||||.722
91602085|NCT05523973|183096647|SUPERIORITY|||||||0.28|||||||Sign test|||||||.28
91602086|NCT05523973|183096648|SUPERIORITY|||||||0.15|||||||Sign test|||||||.15
91650362|NCT01335464|183193211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.596||0.3042|TWO_SIDED|95.0|-1.49|4.77|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.77|-1.49|0.3042
91650363|NCT01335464|183193212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276||||0.1818|TWO_SIDED|95.0|0.89|1.83|||Regression, Logistic||Nintedanib 150mg versus placebo|Logistic regression with term treatment||1.83|0.89|0.1818
91602087|NCT05523973|183096649|SUPERIORITY|||||||0.8|||||||Sign test|||||||.8
91786005|NCT05688670|183452507|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.004|TWO_SIDED|95.0|-1.02|-0.22|||t-test, 2 sided|||||-0.22|-1.02|0.004
91786006|NCT05688670|183452508|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.002|TWO_SIDED|95.0|-78.9|-20.1|||t-test, 2 sided|||||-20.1|-78.9|0.002
91602088|NCT05523973|183096650|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
91602089|NCT05523973|183096651|SUPERIORITY|||||||0.92|||||||Sign test|||||||.92
91602090|NCT00132041|183096685|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
91602091|NCT00132041|183096685|OTHER||Success rate|0.19|||||TWO_SIDED|95.0|0.136|0.252||||||logistic regression model after specifying site as cluster (using GEE approach).||0.252|0.136|
91602092|NCT00132041|183096686|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
91602093|NCT00132041|183096686|OTHER||Slope|-3.7913||||0.0004|TWO_SIDED|95.0|-5.9056|-1.6769|||Generlaized estimating equations|Multivariate logistic model. P-value for number of RFA sessions dichotomized 1: more than 1; using the latter as the reference.|This estimate is for the effect of a single RFA sessions (v multiple sessions) in the multivariate model response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.|multivariate logistic regression model was fit using GEEs to correct for site clustering effects, in which, the response variable was success/failure at 18 months and the covariates were tumor size, whether or not a patient received repeated RFA, whether or not a local tumor recurrence occurred, whether or not a remote tumor occurrence occurred, and two common confounding factors - age and gender||-1.6769|-5.9056|0.0004
91602094|NCT00132041|183096687|OTHER||GEE|-0.9101||||0.0221|TWO_SIDED|95.0|-1.6894|-0.1308|||Generlaized Estimating Equations|multivariate GEE model using logistic link|Estimation parameter is for tumor size when controlling for other covariates.|Effect of tumor size in the multivariate model with response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.||-0.1308|-1.6894|0.0221
91786007|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.06||||0.69||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.69
91786008|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.3||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.30
91786009|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||<0.0001
91786010|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.67||||0.001||95.0||||Values from Groups I, II and III were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.001
91602095|NCT00132041|183096689|OTHER||Mean Difference (Final Values)|-0.458|STANDARD_ERROR_OF_MEAN|0.2496||0.06|TWO_SIDED|||||assuming unequal variance (Satterthwaite p)|t-test, 2 sided||Difference represents the size of tumors that do no recur minus those that do.|the mean tumor size in the two groups, recurred and non recurred tumors, will be compared using a t-test assuming H0: recur=non-recurr||||0.06
91602096|NCT00132041|183096691|OTHER||Sensitivity|0.083|||||TWO_SIDED|95.0|0.0|0.38|||||Twelve tumors were detected in the liver specimens, but only one of those was identified by the CT central readers|||0.38|0.00|
91602097|NCT00132041|183096691|OTHER||Specificity|0.75|||||TWO_SIDED|95.0|0.194|0.994|||||The central CT readers correctly identified three out of the four patients without pathologic evidence of tumor|Specificity||0.994|0.194|
91602098|NCT00132041|183096693|OTHER|McNemar's Test to compare success rates after assuming transplants as successes versus after assuming transplants as failures.||||||0.0001|||||||McNemar|||||||0.0001
91602099|NCT05197803|183096694|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (BTE)||||0.0001
91602100|NCT05197803|183096694|SUPERIORITY||Mean Difference (Final Values)|3.57||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (RIC)||||0.0001
91602101|NCT00167245|183096720|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91602102|NCT00167245|183096721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||Generalized Estimating Equations|||||||0.45
91602103|NCT00167245|183096722|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4|TWO_SIDED|95.0|-2.1|5.2|||t-test, 2 sided|||||5.2|-2.1|0.4
91602104|NCT01307033|183096780|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|0.2|||||TWO_SIDED|95.0|-1.7|2.2|||Constained logitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||2.2|-1.7|
91602105|NCT01307033|183096781|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-2.3|||||TWO_SIDED|95.0|-5.0|0.5|||Constained longitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||0.5|-5.0|
91602106|NCT02274688|183096783|SUPERIORITY||||||=|0.01|||||||Wald Chi-Square=11.29, df=3, P=0.01|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.01
91650364|NCT01335464|183193214|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.6793|TWO_SIDED|95.0|0.56|2.46|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150mg bid versus placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||2.46|0.56|0.6793
91522811|NCT02696564|182920883|SUPERIORITY||Relative rate (losartan to placebo)|0.36||||0.487|TWO_SIDED|95.0|0.02|6.51|||Negative binomial model|||P-value for rate of severe exacerbations between treatment groups (measured in events per 100 person-years).||6.51|0.02|0.487
91602107|NCT02274688|183096784|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=3.01, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
91786011|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.08||||0.61||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.61
91602108|NCT02274688|183096785|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=4.25, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
91602109|NCT02274688|183096786|SUPERIORITY||||||=|0.55|||||||Wald Chi-Square=2.12, df=3, p=0.55|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.55
91602110|NCT02274688|183096787|SUPERIORITY||||||=|0.32|||||||Wald Chi-Square=3.52, df=3; p=0.32|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.32
91602111|NCT02274688|183096788|SUPERIORITY||||||=|0.26|||||||Wald Chi-Square=4.02, df=3, p=0.26|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.26
91650365|NCT01335464|183193215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.288|TWO_SIDED|95.0|0.29|1.36|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.36|0.29|0.2880
91602112|NCT02274688|183096789|SUPERIORITY||||||=|0.22|||||||Wald Chi-Square=4.44, df=3, p=0.22|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.22
91602113|NCT02274688|183096790|SUPERIORITY||||||=|0.08||||||F(3,507)=2.24, P=0.08|Regression Poisson|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.08
91602114|NCT02274688|183096791|SUPERIORITY|||||||0.36|||||||Wald Chi-Square=3.24, df=3, p=0.36|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||0.36
91602115|NCT00282243|183096809|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.79|||||TWO_SIDED|90.0|85.42|92.29|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||92.29|85.42|
91602116|NCT00282243|183096811|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|81.4|||||TWO_SIDED|90.0|77.88|85.08|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||85.08|77.88|
91602117|NCT01070329|183096830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
91602118|NCT01070329|183096831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.77|-2.62||The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-2.62|-5.77|<0.001
91602119|NCT01070329|183096832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.42||This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.42|-1.47|<0.001
91650366|NCT01335464|183193216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.3515|TWO_SIDED|95.0|0.25|1.47|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.47|0.25|0.3515
91602120|NCT01070329|183096832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001|TWO_SIDED|95.0|-1.42|-0.53||This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.53|-1.42|<0.001
91602121|NCT01070329|183096832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.49|-1.41|<0.001
91602122|NCT01070329|183096832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.001|TWO_SIDED|95.0|-4.16|-1.61||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-1.61|-4.16|<0.001
91602123|NCT01070329|183096833|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||<0.001
91602124|NCT01070329|183096834|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.|Cochran-Mantel-Haenszel|||||||0.173
91602125|NCT01070329|183096835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|||||TWO_SIDED|95.0|-4.13|-1.48|||Mixed Models Analysis|Fourth gated secondary outcome measure. Statistical significance was not evaluated; prior gated secondary outcome measure failed (p\>0.05).||||-1.48|-4.13|
91602126|NCT01070329|183096836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.05|TWO_SIDED|95.0|0.0|3.34||This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.34|0.00|0.050
91602127|NCT01070329|183096836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.071|TWO_SIDED|95.0|-0.12|2.9||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.|ANCOVA|||||2.90|-0.12|0.071
91602128|NCT01070329|183096837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.05|TWO_SIDED|95.0|0.0|3.82||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.82|0.00|0.050
91650367|NCT01335464|183193217|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.4869|TWO_SIDED|95.0|0.26|1.82|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.82|0.26|0.4869
91522812|NCT04067401|182920908|SUPERIORITY||Effect size|-0.13||||0.062|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.01|-.29|.062
91786012|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.02||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.02
91786013|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.45||||0.002||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||0.002
91786014|NCT00488683|183452509|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.08
91522813|NCT04067401|182920909|SUPERIORITY||Effect size|-0.23||||0.001|TWO_SIDED|95.0|-0.39|-0.09|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.09|-.39|.001
91522814|NCT04067401|182920910|SUPERIORITY||Effect size|-0.16||||0.027|TWO_SIDED|95.0|-0.34|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.34|.027
91786015|NCT00488683|183452509|SUPERIORITY_OR_OTHER||R-square|0.004||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||
91786016|NCT00488683|183452509|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||
91786017|NCT00488683|183452509|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||
91650368|NCT01335464|183193218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.443|TWO_SIDED|95.0|0.36|1.51|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.51|0.36|0.4430
91650369|NCT01335464|183193219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.3558|TWO_SIDED|95.0|0.52|1.25|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.25|0.52|0.3558
91650370|NCT01335464|183193220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.181||0.1138|TWO_SIDED|95.0|-0.07|0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.64|-0.07|0.1138
91650371|NCT01335464|183193221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.0896||0.865|TWO_SIDED|95.0|-0.191|0.161|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.161|-0.191|0.8650
91650372|NCT01365845|183193225|SUPERIORITY_OR_OTHER||Non-parametric paired t-test (Wilcoxon)|29.1||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
91650373|NCT03210259|183193237|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the least squares (LS) means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|105.19|||||TWO_SIDED|90.2|96.58|114.64|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||114.64|96.58|
91650374|NCT03210259|183193238|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the LS means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|101.14|||||TWO_SIDED|90.2|93.26|109.7|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||109.70|93.26|
91786018|NCT00488683|183452509|SUPERIORITY_OR_OTHER||R-square|0.45||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||
91786019|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.70
91786020|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.37||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.37
91786021|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.66|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||<0.0001
91650375|NCT03210259|183193239|OTHER||Least squares means ratio|107.31|||||TWO_SIDED|90.2|97.33|118.43|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm as numerator and the continuous arm as the denominator.|No hypothesis was defined and no statistical test was performed.||118.43|97.33|
91650376|NCT03210259|183193241|OTHER||Risk Difference (RD)|5.75|||||TWO_SIDED|90.0|-2.45|13.96|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||13.96|-2.45|
91650377|NCT03210259|183193242|OTHER||Risk Difference (RD)|5.63|||||TWO_SIDED|90.0|-4.35|15.62|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||15.62|-4.35|
91650378|NCT00990561|183193289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis = there is no difference between using ultravate once daily vs. twice daily||||<0.001
91786022|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.9|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||<0.0001
91650379|NCT03182686|183193298|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"H0:π ≤ π0 versus HA:π \> π0~Where π0 is the hypothesized clinically significant value for the proportion of responders. The value will be 30% in this study. This test will be tested using an exact binomial test. That is, given the sample size of n, the number of responders X, and the value of π0 =0.30, then probability that X or more events would be observed will be calculated as the p-value. Since this is a one-sided test, the alpha level will be 0.025."||||<0.0001
91786023|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.01||||0.94||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.94
91786024|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.70
91786025|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.3||||0.04||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||0.04
91522815|NCT04067401|182920911|SUPERIORITY||Effect size|-0.24||||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.08|-.41|.002
91602129|NCT01070329|183096837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.007|TWO_SIDED|95.0|0.5|3.1||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.10|0.50|0.007
91602130|NCT01070329|183096837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.063|TWO_SIDED|95.0|-0.09|3.5||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.50|-0.09|0.063
91602131|NCT01070329|183096837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.004|TWO_SIDED|95.0|0.6|3.02||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.02|0.60|0.004
91602132|NCT01070329|183096838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-3.18|-0.96|||Mixed Models Analysis|Fifth gated secondary outcome measure. Statistical significance was not evaluated; the third gated secondary outcome measure failed (p\>0.05).||||-0.96|-3.18|
91602133|NCT01070329|183096839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.007|TWO_SIDED|95.0|-0.93|-0.15||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.93|0.007
91786026|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46||||0.004||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||0.004
91602134|NCT01070329|183096839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.002|TWO_SIDED|95.0|-0.93|-0.22||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.22|-0.93|0.002
91602135|NCT01070329|183096840|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.021
91650380|NCT01989195|183193358|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91786027|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.005||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||
91786028|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||
91786029|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.43||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||
91786030|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.82||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||
91786031|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.68||95.0||||Values from Group 1, 2 and 2 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.68
91786032|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.46||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.46
91786033|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.2||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.08
91786034|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45|||<|0.001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||<0.001
91786035|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.04||||0.75||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.75
91786036|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.27||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.27
91786037|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.07||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.07
91786038|NCT00488683|183452510|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.23||||0.06||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||0.06
91786039|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.0029||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
91709482|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9604|TWO_SIDED|95.0|0.31|3.07|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.07|0.31|0.9604
91522816|NCT04067401|182920912|SUPERIORITY||Effect size|0.01||||0.821|TWO_SIDED|95.0|-0.12|0.11|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.11|-.12|.821
91602136|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.85|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.85|<0.001
91602137|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.003|TWO_SIDED|95.0|-0.64|-0.13||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.13|-0.64|0.003
91602138|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
91602139|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.86|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.86|<0.001
91602140|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.008|TWO_SIDED|95.0|-0.75|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.75|0.008
91602141|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.004|TWO_SIDED|95.0|-0.8|-0.15||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.80|0.004
91602142|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.12|-0.72|0.006
91602143|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.012|TWO_SIDED|95.0|-0.72|-0.09||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.09|-0.72|0.012
91602144|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.029|TWO_SIDED|95.0|-0.7|-0.04||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.04|-0.70|0.029
91602145|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.037|TWO_SIDED|95.0|-0.75|-0.02||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.02|-0.75|0.037
91602146|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.006|TWO_SIDED|95.0|-0.81|-0.14||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.14|-0.81|0.006
91602147|NCT01070329|183096841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15||This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.74|0.004
91602148|NCT01070329|183096842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.49||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.49|-0.90|<0.001
91602149|NCT01070329|183096843|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.116
91602150|NCT03706365|183096855|OTHER||Hazard Ratio (HR)|0.829||||0.2123|TWO_SIDED|95.0|0.619|1.111|||Log Rank|||||1.111|0.619|0.2123
91602151|NCT03706365|183096856|OTHER||Hazard Ratio (HR)|0.637||||0.0026|TWO_SIDED|95.0|0.474|0.856|||Log Rank|||||0.856|0.474|0.0026
91602152|NCT03706365|183096857|OTHER||Hazard Ratio (HR)|0.842||||0.2899|TWO_SIDED|95.0|0.611|1.16|||Log Rank|||||1.160|0.611|0.2899
91602153|NCT03706365|183096859|OTHER||Hazard Ratio (HR)|0.731||||0.3531|TWO_SIDED|95.0|0.377|1.419|||Log Rank|||||1.419|0.377|0.3531
91602154|NCT03706365|183096860|OTHER||Hazard Ratio (HR)|0.927||||0.6507|TWO_SIDED|95.0|0.669|1.285|||Log Rank|||||1.285|0.669|0.6507
91709483|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9752|TWO_SIDED|95.0|0.32|3.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.25|0.32|0.9752
91602155|NCT03706365|183096861|OTHER||Hazard Ratio (HR)|0.768||||0.1807|TWO_SIDED|95.0|0.522|1.131|||Log Rank|||||1.131|0.522|0.1807
91602156|NCT03706365|183096866|OTHER||Hazard Ratio (HR)|0.935||||0.697|TWO_SIDED|95.0|0.665|1.314|||Log Rank|||||1.314|0.665|0.6970
91602157|NCT01175005|183096875|SUPERIORITY_OR_OTHER|||||||0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
91602158|NCT00254566|183096876|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-0.9||||||95.0|-5.8|3.9|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval|95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.9|-5.8|
91602159|NCT00254566|183096877|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in the percentage of participants with Cure and the 95% CI|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.4|-8.5|
91602160|NCT00254566|183096878|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.||3.4|-8.5|
91602161|NCT00254566|183096879|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||||95.0|-4.5|3.3|||||Risk difference is the difference in eradication rates of pathogens by treatment|||3.3|-4.5|
91602162|NCT00254566|183096880|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.33||||0.159||95.0|0.9|2.0||p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate|Regression, Cox|||Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because \<50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups' recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).||2.0|0.9|0.159
91602163|NCT00254566|183096881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.57||95.0|-0.21|0.12|||ANCOVA|Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates||||0.12|-0.21|0.57
91602164|NCT00254566|183096881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.82||95.0|-0.13|0.1|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.10|-0.13|0.82
91602165|NCT00254566|183096882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.81||95.0|-0.21|0.17|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.17|-0.21|0.81
91602166|NCT00254566|183096882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.87||95.0|-0.12|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.12|0.87
91650381|NCT01512979|183193371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.13|-0.46||The model includes treatment and continuous baseline HbA1c.|ANCOVA|||||-0.46|-1.13|<0.0001
91786040|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.0059||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
91786041|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
91786042|NCT00488683|183452510|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
91786043|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.26||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
91786044|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.59||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.59
91786045|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.006||||0.98||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.98
91786046|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.2||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.20
91786047|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.08
91786048|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.68
91786049|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.006||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.006
91786050|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.16||||0.48||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.48
91786051|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.26||||0.46||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
91786052|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.40
91786053|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.12||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.60
91786054|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.03
91786055|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.001
91602167|NCT00254566|183096883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.385||95.0|-0.27|0.1|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.10|-0.27|0.385
91602168|NCT00254566|183096883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.56||95.0|-0.17|0.09|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.09|-0.17|0.56
91602169|NCT00254566|183096884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.62||95.0|-0.26|0.16|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.16|-0.26|0.62
91602170|NCT00254566|183096884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8||95.0|-0.18|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.18|0.80
91602171|NCT03222427|183096885|OTHER||Ratio of Geometric Least Squares Means|0.952|||||TWO_SIDED|90.0|0.769|1.18||||||||1.18|0.769|
91602172|NCT01989221|183096887|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|0.12|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean GCSI-DD scores during one week at baseline were compared to mean GCSI-DD scores during the second week of Sancuso treatment.|||||<0.01
91786056|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.0||||1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||1.00
91786057|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.24
91786058|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.34
91786059|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
91786060|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
91786061|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
91786062|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
91786063|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
91786064|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
91786065|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
91786066|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
91786067|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.0002||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.0002
91786068|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.03||||0.9||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.90
91602173|NCT01989221|183096888|OTHER||Mean Difference (Final Values)|1.01|STANDARD_DEVIATION|0.27|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05|t-test, 2 sided||Mean nausea and vomiting symptom scores during one week at baseline were compared to mean symptom scores during the second week of Sancuso treatment.|||||<0.01
91602174|NCT01688050|183096937|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|All-cause mortality rate (%)|2.0|||||TWO_SIDED|95.0|0.0|5.88|||||Wald method|||5.88|0|
91602175|NCT01688050|183096938|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Aortic injury-related mortality rate (%)|0.0|||||TWO_SIDED|95.0|0.0|7.1|||||Exact method|||7.1|0|
91602176|NCT01688050|183096939|OTHER|The primary effectiveness endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Device success rate (%)|96.0|||||TWO_SIDED|95.0|90.6|100.0|||||Wald method|||100|90.6|
91602177|NCT00356031|183096957|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
91602178|NCT00356031|183096958|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
91602179|NCT01110395|183096964|OTHER|Bland and Altman|Mean + SD|0.05|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|||||Bland Altman|mean + SD|Bland Altman|We have provided all the information that is available to us. The PI has left the institution and we are unable to contact him. We have no further data to correct the errors.|We are unable to provide any further data that has been requested. We have supplied all the data that we can possibly provide because the PI has left the institution and we are unable to contact him. We have no other data.|There are no other statistical analysis. We have provided all the information that is available to us. We have no other data available to us because the PI has left the institution and we are unable to contact him.|||
91602180|NCT01110395|183096964|OTHER||||||<|0.05|||||||Mean + SD|||||||<0.05
91602181|NCT01925209|183097049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.59|STANDARD_ERROR_OF_MEAN|14.331||0.221|TWO_SIDED|99.0|-19.63|54.8|||mixed model repeated measures|||||54.80|-19.63|0.2210
91522817|NCT04067401|182920913|SUPERIORITY||Effect size|-0.14||||0.024|TWO_SIDED|95.0|-0.31|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.31|.024
91602182|NCT01925209|183097049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.59|STANDARD_ERROR_OF_MEAN|14.176||0.1909|TWO_SIDED|99.0|-18.21|55.4|||mixed model repeated measure|||||55.40|-18.21|0.1909
91602183|NCT01925209|183097049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|14.121||0.9263|TWO_SIDED|99.0|-37.97|35.36|||mixed models repeated measures|||||35.36|-37.97|0.9263
91602184|NCT05384041|183097082|SUPERIORITY|||||||0.056|||||||Regression, Linear|||Intent to Treat analyses||||0.056
91602185|NCT05384041|183097083|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Difference (Active - Control) at Week 1||||0.048
91602186|NCT05384041|183097084|SUPERIORITY|||||||0.2595|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2595
91602187|NCT05384041|183097084|SUPERIORITY|||||||0.1286|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1286
91602188|NCT05384041|183097084|SUPERIORITY|||||||0.1449|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1449
91650382|NCT01512979|183193372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.0032||95.0|-28.0|-5.7||The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.|ANCOVA|||||-5.7|-28.0|0.0032
91602189|NCT05384041|183097085|SUPERIORITY|||||||0.2065|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2065
91602190|NCT05384041|183097085|SUPERIORITY|||||||0.1349|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1349
91602191|NCT05384041|183097085|SUPERIORITY|||||||0.1142|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1142
91602192|NCT05384041|183097086|SUPERIORITY|||||||0.231|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.231
91602193|NCT05384041|183097086|SUPERIORITY|||||||0.192|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.192
91602194|NCT05384041|183097086|SUPERIORITY|||||||0.045|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.045
91602195|NCT05384041|183097088|SUPERIORITY|||||||0.005|||||||Regression, Linear|||||||0.005
91602196|NCT05384041|183097089|SUPERIORITY|||||||0.0026|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.0026
91602197|NCT05384041|183097089|SUPERIORITY|||||||0.4706|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.4706
91602198|NCT05384041|183097089|SUPERIORITY|||||||0.0197|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.0197
91602199|NCT05384041|183097089|SUPERIORITY|||||||0.4858|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.4858
91602200|NCT05384041|183097089|SUPERIORITY|||||||0.0183|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.0183
91786069|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.47||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.02
91786070|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.12||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.12
91786071|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.22||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.22
91602201|NCT05384041|183097089|SUPERIORITY|||||||0.7885|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.7885
91602202|NCT05384041|183097090|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||<0.001
91602203|NCT05384041|183097090|SUPERIORITY|||||||0.45|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.450
91602204|NCT05384041|183097090|SUPERIORITY|||||||0.008|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.008
91602205|NCT05384041|183097090|SUPERIORITY|||||||0.438|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.438
91786072|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||<0.0001
91602206|NCT05384041|183097090|SUPERIORITY|||||||0.016|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.016
91602207|NCT05384041|183097090|SUPERIORITY|||||||0.355|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.355
91602208|NCT05384041|183097091|SUPERIORITY|||||||0.046|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.046
91602209|NCT05384041|183097091|SUPERIORITY|||||||0.351|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.351
91602210|NCT05384041|183097091|SUPERIORITY|||||||0.053|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.053
91602211|NCT05384041|183097091|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.120
91602212|NCT05384041|183097091|SUPERIORITY|||||||0.17|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.170
91602213|NCT05384041|183097091|SUPERIORITY|||||||0.122|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.122
91602214|NCT05384041|183097092|SUPERIORITY|||||||0.044|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.044
91602215|NCT05384041|183097092|SUPERIORITY|||||||0.751|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.751
91602216|NCT05384041|183097092|SUPERIORITY|||||||0.013|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.013
91650383|NCT01512979|183193374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0031||95.0|1.573|9.328||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||9.328|1.573|0.0031
91786073|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.15||||0.82||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.82
91602217|NCT05384041|183097092|SUPERIORITY|||||||0.318|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.318
91602218|NCT05384041|183097092|SUPERIORITY|||||||0.173|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.173
91786074|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.66||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.66
91786075|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.03||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.03
91602219|NCT05384041|183097092|SUPERIORITY|||||||0.142|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.142
91602220|NCT05384041|183097093|SUPERIORITY|||||||0.026|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.026
91602221|NCT05384041|183097093|SUPERIORITY|||||||0.241|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.241
91602222|NCT05384041|183097093|SUPERIORITY|||||||0.059|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.059
91602223|NCT05384041|183097093|SUPERIORITY|||||||0.478|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.478
91602224|NCT05384041|183097093|SUPERIORITY|||||||0.009|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.009
91602225|NCT05384041|183097093|SUPERIORITY|||||||0.729|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.729
91602226|NCT05384041|183097094|SUPERIORITY|||||||0.044|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.044
91602227|NCT05384041|183097094|SUPERIORITY|||||||0.067|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.067
91602228|NCT05384041|183097094|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
91602229|NCT05384041|183097094|SUPERIORITY|||||||0.006|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.006
91602230|NCT05384041|183097094|SUPERIORITY|||||||0.036|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.036
91602231|NCT05384041|183097094|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
91602232|NCT05384041|183097094|SUPERIORITY|||||||0.914|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.914
91602233|NCT05384041|183097094|SUPERIORITY|||||||0.887|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.887
91602234|NCT05384041|183097094|SUPERIORITY|||||||0.791|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.791
91602235|NCT00510276|183097098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82||||0.005|TWO_SIDED|95.0|1.44|8.2||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.20|1.44|0.005
91602236|NCT00510276|183097099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.006|TWO_SIDED|95.0|1.68|10.12||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.12|1.68|0.006
91602237|NCT00510276|183097100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73||||0.018|TWO_SIDED|95.0|1.0|10.46||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.46|1.00|0.018
91522818|NCT04067401|182920914|SUPERIORITY||Effect size|0.18||||0.012|TWO_SIDED|95.0|0.04|0.29|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.29|.04|.012
91522819|NCT04067401|182920915|SUPERIORITY||Effect size|0.21||||0.01|TWO_SIDED|95.0|0.05|0.35||Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component|Mixed Models Analysis|||||.35|.05|.010
91522820|NCT00141739|182920932|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.001
91522821|NCT02287584|182920934|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.007|TWO_SIDED|95.0|-9.6|-1.6||adjusted p value, Hochberg procedure|Mixed Models Analysis|||Using Mixed Model for Repeated Measures||-1.6|-9.6|0.007
91522822|NCT02287584|182920934|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-14.4|-6.4||adjusted p-value, Hochberg procedure|Mixed Models Analysis|||||-6.4|-14.4|<0.001
91522823|NCT01892345|182920944|OTHER|Treatment Effect|Hazard Ratio (HR)|0.058|||<|0.0001|TWO_SIDED|95.0|0.017|0.197|||Stratified Log-Rank Test||HR based on a stratified Cox proportional hazards model. Confidence interval = Wald confidence interval. HR for eculizumab compared with placebo represented a 94.2% reduction in the risk of relapse, 95% Wald confidence interval (80.3%, 98.3%).|||0.197|0.017|<0.0001
91522824|NCT00659984|182920974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.2||||0.363|TWO_SIDED|95.0|-3.4|13.9|||Cochran Armitage Trend Test|||||13.9|-3.4|0.363
91522825|NCT02657317|182920986|SUPERIORITY||Mean Difference (Final Values)|-9.1||||0.001|TWO_SIDED|95.0|-14.4|-3.7|||GLMM|||To detect a medium effect (d = 0.50) at 2-sided α = 0.05, 50 participants were needed in each study arm (total N = 100). We anticipated 30% attrition in each arm. Data for the primary aim were analyzed using generalized linear mixed models adjusting for baseline levels of prognostic variable and using random intercepts at the level of participants. The primary analysis was based on intent-to-treat.||-3.7|-14.4|.001
91522826|NCT01800968|182921061|SUPERIORITY_OR_OTHER|||||||0.3087|||||||Rank score|||||||0.3087
91522827|NCT01800968|182921062|SUPERIORITY_OR_OTHER|||||||0.1549|||||||Regression, Linear|||||||0.1549
91522828|NCT01800968|182921063|SUPERIORITY_OR_OTHER|||||||0.1932|||||||Regression, Linear|||||||0.1932
91522829|NCT01800968|182921064|SUPERIORITY_OR_OTHER|||||||0.9535|||||||Regression, Linear|||||||0.9535
91522830|NCT01800968|182921065|SUPERIORITY_OR_OTHER|||||||0.8548|||||||Regression, Linear|||||||0.8548
91522831|NCT01800968|182921066|SUPERIORITY_OR_OTHER|||||||0.4266|||||||Regression, Linear|||||||0.4266
91522832|NCT01800968|182921067|SUPERIORITY_OR_OTHER|||||||0.1705|||||||Regression, Linear|||||||0.1705
91522833|NCT01800968|182921068|SUPERIORITY_OR_OTHER|||||||0.1309|||||||Regression, Linear|||||||0.1309
91602238|NCT00510276|183097101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36||||0.034|TWO_SIDED|95.0|0.33|8.39||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.39|0.33|0.034
91602239|NCT00510276|183097102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.074|TWO_SIDED|95.0|-0.33|7.12||A gate-keeper strategy was applied to adjust for multiple tests.|ANCOVA|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||7.12|-0.33|0.074
91522834|NCT01800968|182921069|SUPERIORITY_OR_OTHER|||||||0.792|||||||Regression, Linear|||||||0.7920
91522835|NCT01800968|182921070|SUPERIORITY_OR_OTHER|||||||0.7026|||||||Regression, Linear|||||||0.7026
91522836|NCT01800968|182921071|SUPERIORITY_OR_OTHER|||||||0.2662|||||||Regression, Linear|||||||0.2662
91522837|NCT01800968|182921072|SUPERIORITY_OR_OTHER|||||||0.6395|||||||Regression, Linear|||||||0.6395
91522838|NCT01800968|182921073|SUPERIORITY_OR_OTHER|||||||0.8218|||||||Regression, Linear|||||||0.8218
91522839|NCT01800968|182921074|SUPERIORITY_OR_OTHER|||||||0.1124|||||||Regression, Linear|||||||0.1124
91522840|NCT01800968|182921075|SUPERIORITY_OR_OTHER|||||||0.8088|||||||Regression, Linear|||||||0.8088
91522841|NCT01800968|182921076|SUPERIORITY_OR_OTHER|||||||0.7764|||||||Log Rank|||||||0.7764
91522842|NCT01800968|182921077|SUPERIORITY_OR_OTHER|||||||0.1701|||||||Log Rank|||||||0.1701
91522843|NCT01800968|182921078|SUPERIORITY_OR_OTHER|||||||0.6532|||||||Regression, Linear|||||||0.6532
91522844|NCT01800968|182921079|SUPERIORITY_OR_OTHER|||||||0.2033|||||||Rank score|||||||0.2033
91522845|NCT00755040|182921090|SUPERIORITY||Odds Ratio (OR)|1.11|||>|0.99|TWO_SIDED|95.0|||||Fisher Exact|||||||>0.99
91522846|NCT02220894|182921107|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.86||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||0.86|0.58|0.0003
91522847|NCT02220894|182921108|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0012|TWO_SIDED|95.0|0.65|0.91||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.91|0.65|0.0012
91522848|NCT02220894|182921109|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0013|TWO_SIDED|95.0|0.71|0.93||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.93|0.71|0.0013
91522849|NCT02220894|182921110|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.026|TWO_SIDED|95.0|0.69|1.0||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||1.00|0.69|0.0260
91522850|NCT02220894|182921111|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2134|TWO_SIDED|95.0|0.8|1.1||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.10|0.80|0.2134
91522851|NCT02220894|182921112|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7964|TWO_SIDED|95.0|0.93|1.19||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.19|0.93|0.7964
91522852|NCT02220894|182921113|SUPERIORITY||Difference in Percentage (DP)|7.0||||0.0353|TWO_SIDED|95.0|-0.6|14.6||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).|||14.6|-0.6|0.0353
91522853|NCT02220894|182921114|SUPERIORITY||Difference in Percentage (DP)|4.6||||0.0744|TWO_SIDED|95.0|-1.7|10.9||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||10.9|-1.7|0.0744
91522854|NCT02220894|182921115|SUPERIORITY||Difference in Percentage (DP)|0.6||||0.406|TWO_SIDED|95.0|-4.2|5.4||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||5.4|-4.2|0.4060
91522855|NCT00394355|182921132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way analysis of variance (ANOVA) model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.261
91522856|NCT00394355|182921132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.644
91602240|NCT00510276|183097103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.63|-0.24|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.24|-0.63|<0.001
91602241|NCT00510276|183097104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.94|-2.15|||Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.15|-5.94|<0.001
91602242|NCT00510276|183097105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.02|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.||-0.04|-0.45|0.020
91602243|NCT00510276|183097106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.282|TWO_SIDED|95.0|-1.19|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.19|0.282
91602244|NCT00510276|183097107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.556|TWO_SIDED|95.0|-2.21|1.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||1.19|-2.21|0.556
91602245|NCT00510276|183097108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Pearson's Correlation Coefficient|||Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.||||<0.001
91602246|NCT00510276|183097109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.198|TWO_SIDED|95.0|-0.39|0.08|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.08|-0.39|0.198
91650384|NCT01512979|183193375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.0025||95.0|1.458|5.849||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||5.849|1.458|0.0025
91650385|NCT01512979|183193376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.448||||0.0008||95.0|1.453|4.123||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||4.123|1.453|0.0008
91650386|NCT00529568|183193382|SUPERIORITY_OR_OTHER||Percentage difference in SVR|6.0||||0.0202|TWO_SIDED|95.0|1.2|10.9||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||10.9|1.2|0.0202
91650387|NCT00951899|183193441|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||A P value \< 0.05 was considered statistically significant|t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Colesevelam subjects||||0.0006
91650388|NCT00951899|183193441|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Placebo subjects||||0.30
91650389|NCT01123980|183193449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D \> 0.4% against HA: D =\< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.25|0.02||The p-values correspond to one-sided hypotheses of either non-inferiority or superiority, statistical significance level is 2.5%.|ANCOVA|The estimates are from a normal linear regression model with treatment, country and previous OADs as factors and baseline HbA1c as a covariate||H0: The mean treatment difference (BIAsp 30 minus insulin glargine) \> 0.4%. HA: The mean treatment difference (BIAsp 30 minus insulin glargine) =\< 0.4%. Sample size was calculated to achieve a power of at least 90%, assuming an equal change in HbA1c and a common standard deviation of 1.25%||0.02|-0.25|< 0.001
91786076|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.53||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.53
91650390|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||<|0.001||95.0|-0.24|0.19||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.19|-0.24|<0.001
91786077|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.35||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.35
91786078|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.47||||0.09||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.09
91786079|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.04
91786080|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.10
91602247|NCT00510276|183097110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.825|TWO_SIDED|95.0|-0.33|0.26|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.26|-0.33|0.825
91602248|NCT00510276|183097112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.233|TWO_SIDED|95.0|-0.53|2.17|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||2.17|-0.53|0.233
91602249|NCT00510276|183097113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.676|TWO_SIDED|95.0|-0.24|0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.37|-0.24|0.676
91602250|NCT00510276|183097114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.382|TWO_SIDED|95.0|-1.0|0.39|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.39|-1.00|0.382
91602251|NCT00510276|183097115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.656|TWO_SIDED|95.0|-1.24|0.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.78|-1.24|0.656
91602252|NCT00510276|183097116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.201|TWO_SIDED|95.0|-4.08|0.86|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.86|-4.08|0.201
91602253|NCT00510276|183097117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.06|||<|0.001|TWO_SIDED|95.0|-7.39|-2.72|||Mixed Models Analysis|Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.||Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.||-2.72|-7.39|<0.001
91602254|NCT00510276|183097118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.933|TWO_SIDED|95.0|-16.41|17.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||17.63|-16.41|0.933
91602255|NCT00510276|183097119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95||||0.007|TWO_SIDED|95.0|-5.09|-0.81|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.81|-5.09|0.007
91602256|NCT00510276|183097120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.219|TWO_SIDED|95.0|-1.5|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.50|0.219
91602257|NCT00510276|183097121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.58||||0.002|TWO_SIDED|95.0|-12.37|-2.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.78|-12.37|0.002
91602258|NCT00510276|183097122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.644|TWO_SIDED|95.0|-0.47|0.29|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.29|-0.47|0.644
91602259|NCT00510276|183097123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.097|TWO_SIDED|95.0|-0.02|0.25|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.25|-0.02|0.097
91786081|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.56||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.56
91786082|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.84||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.84
91786083|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
91602260|NCT00510276|183097124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.002|TWO_SIDED|95.0|-1.57|-0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.37|-1.57|0.002
91602261|NCT00510276|183097125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.044|TWO_SIDED|95.0|-1.33|-0.02|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.02|-1.33|0.044
91602262|NCT00510276|183097126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49||||0.003|TWO_SIDED|95.0|-7.43|-1.55|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-1.55|-7.43|0.003
91602263|NCT00510276|183097127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.456|TWO_SIDED|95.0|-0.51|0.23|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.23|-0.51|0.456
91602264|NCT00510276|183097128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.051|TWO_SIDED|95.0|-1.31|0.0|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.00|-1.31|0.051
91602265|NCT00510276|183097129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.002|TWO_SIDED|95.0|-2.19|-0.47|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.47|-2.19|0.002
91786084|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.001||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
91786085|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
91786086|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
91786087|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
91602266|NCT00510276|183097130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.045|TWO_SIDED|95.0|-1.04|-0.01|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.01|-1.04|0.045
91602267|NCT00510276|183097131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.35|-0.32|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.32|-1.35|0.001
91602268|NCT00510276|183097132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.008|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.19|-1.23|0.008
91602269|NCT00510276|183097133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.98|-0.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.63|-1.98|<0.001
91602270|NCT00510276|183097134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.065|TWO_SIDED|95.0|-1.42|0.04|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.04|-1.42|0.065
91602271|NCT00510276|183097135|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Cochran-Mantel-Haenszel|Tested was smoking status across treatment.||Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo||||0.788
91602272|NCT00510276|183097136|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||Tested was smoking status across treatment.|Cochran-Mantel-Haenszel|||Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo||||0.482
91650391|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001||95.0|-0.45|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.45|<0.001
91602273|NCT03434379|183097185|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|||At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.79|0.42|0.0006
91602274|NCT03434379|183097185|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0009|TWO_SIDED|95.0|0.52|0.85|||Log Rank|||At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.85|0.52|0.0009
91602275|NCT03434379|183097186|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.47|<0.0001
91786088|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
91786089|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
91786090|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
91602276|NCT03434379|183097187|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0026|TWO_SIDED|95.0|0.25|0.76|||Log Rank|||At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.25|0.0026
91602277|NCT03434379|183097187|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0019|TWO_SIDED|95.0|0.35|0.8|||Log Rank|||At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.80|0.35|0.0019
91602278|NCT03434379|183097188|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0117|TWO_SIDED|95.0|0.4|0.9|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.40|0.0117
91602279|NCT03434379|183097189|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.68|5.01|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.01|1.68|<0.0001
91650392|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|-0.31|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.31|<0.001
91602280|NCT03434379|183097190|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.02|5.71|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.71|2.02|<0.0001
91602281|NCT03434379|183097191|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.99|12.66|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.66|2.99|<0.0001
91650393|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001||95.0|-0.26|0.82||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.82|-0.26|<0.001
91786091|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.08
91786092|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.74||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.74
91786093|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.01||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.94
91786094|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.09||||0.51||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
91786095|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.27||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.12
91786096|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.25||||0.09||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.09
91786097|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.05||||0.81||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.81
91786098|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.28||||0.07||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.07
91786099|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.02
91786100|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.59||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.59
91786101|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.1||||0.51||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
91786102|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.9||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.9
91786103|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.02
91602282|NCT03434379|183097192|SUPERIORITY||Hazard Ratio (HR)|0.23||||0.0051|TWO_SIDED|95.0|0.08|0.7|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.70|0.08|0.0051
91602283|NCT03434379|183097193|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.0048|TWO_SIDED|95.0|0.12|0.73|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.12|0.0048
91650394|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||<|0.001||95.0|0.22|1.06||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||1.06|0.22|<0.001
91786104|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.19||||0.2||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.20
91786105|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.34||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.34
91786106|NCT00488683|183452511|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.33||||0.04||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.04
91786107|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
91786108|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.0027||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
91786109|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.0002||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
91786110|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.0077||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
91786111|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
91786112|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
91786113|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.0023||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
91786114|NCT00488683|183452511|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
91786115|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.25||||0.59||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.59
91786116|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.68
91786117|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.36||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.12
91786118|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.22||||0.26||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.26
91786119|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.08
91786120|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.17||||0.42||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.42
91786121|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.02
91786122|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.65||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.65
91786123|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.58||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.58
91786124|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.19||||-0.51||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||-0.51
91786125|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.24
91522857|NCT00394355|182921133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.359
91522858|NCT00394355|182921133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.390
91522859|NCT00394355|182921134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.169
91522860|NCT00394355|182921134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.526|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.526
91522861|NCT00394355|182921135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||<0.001
91522862|NCT00394355|182921135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||0.023
91602284|NCT03434379|183097194|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.4187|TWO_SIDED|95.0|0.16|2.15|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||2.15|0.16|0.4187
91786126|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.06||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.06
91786127|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.001
91786128|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.32||||0.12||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.12
91786129|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.49||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.18
91786130|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.34
91786131|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
91786132|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
91786133|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
91786134|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
91786135|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
91786136|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
91786137|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.6||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
91786138|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
91786139|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.83||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.001
91786140|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.57||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.57
91786141|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.65||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.001
91602285|NCT03434379|183097195|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.46|<.0001
91602286|NCT03434379|183097196|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.36|<.0001
91602287|NCT03434379|183097197|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0105|TWO_SIDED|95.0|0.53|0.92|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.92|0.53|0.0105
91602288|NCT03434379|183097198|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0063|TWO_SIDED|95.0|0.52|0.9|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.52|0.0063
91602289|NCT03434379|183097199|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.35|<.0001
91602290|NCT03434379|183097200|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.78|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.78|0.32|0.0019
91602291|NCT03434379|183097200|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0879|TWO_SIDED|95.0|0.42|1.06|||Log Rank|||AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.06|0.42|0.0879
91786142|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.11||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.11
91786143|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.02||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.94
91786144|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.0003||||1||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||1.00
91602292|NCT03434379|183097201|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.37|0.68|||Log Rank|||AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.68|0.37|<.0001
91602293|NCT03434379|183097201|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.2159|TWO_SIDED|95.0|0.53|1.15|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.15|0.53|0.2159
91602294|NCT03434379|183097202|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.31|0.57|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.57|0.31|<0.0001
91602295|NCT03434379|183097202|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.35|0.73|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.73|0.35|0.0002
91602296|NCT03434379|183097203|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.73|||Log Rank|||Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.39|<.0001
91786145|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.004||||1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||1.00
91786146|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.3||||0.37||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.37
91786147|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.52||||0.09||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.09
91786148|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.40
91602297|NCT03434379|183097203|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0019|TWO_SIDED|95.0|0.46|0.84|||Log Rank|||Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.84|0.46|0.0019
91602298|NCT03434379|183097203|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0028|TWO_SIDED|95.0|0.46|0.85|||Log Rank|||GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.85|0.46|0.0028
91602299|NCT03434379|183097208|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0036|TWO_SIDED|95.0|1.53|13.86|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||13.86|1.53|0.0036
91786149|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.2||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.20
91786150|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.03
91786151|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.48||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.07
91786152|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.3||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.30
91786153|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.26||||0.74||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.74
91786154|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.378||||0.25||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.25
91602300|NCT03434379|183097209|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0013|TWO_SIDED|95.0|1.72|12.87|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.87|1.72|0.0013
91602301|NCT03434379|183097210|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0052|TWO_SIDED|95.0|1.47|17.39|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||17.39|1.47|0.0052
91602302|NCT03434379|183097211|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.4581|TWO_SIDED|95.0|0.02|5.85|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.85|0.02|0.4581
91602303|NCT03434379|183097212|SUPERIORITY||Hazard Ratio (HR)|0.08||||0.01|TWO_SIDED|95.0|0.01|0.91|||Log Rank||Lower limit: \<0.01|Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.91|0.01|0.0100
91786155|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.69||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
91786156|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
91786157|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.42||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
91786158|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
91786159|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0004||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
91786160|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
91786161|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
91786162|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
91786163|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.86||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.86
91790540|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91602304|NCT03434379|183097213|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.3477|TWO_SIDED|95.0|0.03|3.69|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||3.69|0.03|0.3477
91602305|NCT03434379|183097214|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0103|TWO_SIDED|95.0|0.4|0.89|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.89|0.40|0.0103
91602306|NCT03434379|183097215|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0002|TWO_SIDED|95.0|0.33|0.71|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.71|0.33|0.0002
91602307|NCT03434379|183097216|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0927|TWO_SIDED|95.0|0.43|1.07|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.07|0.43|0.0927
91602308|NCT03434379|183097217|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0861|TWO_SIDED|95.0|0.43|1.06|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.06|0.43|0.0861
91602309|NCT03434379|183097218|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0004|TWO_SIDED|95.0|0.33|0.74|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.33|0.0004
91602310|NCT03434379|183097219|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0035|TWO_SIDED|95.0|0.26|0.78|||Log Rank|||Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.78|0.26|0.0035
91602311|NCT03434379|183097219|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.2214|TWO_SIDED|95.0|0.42|1.23|||Log Rank|||Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.23|0.42|0.2214
91602312|NCT03434379|183097219|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0135|TWO_SIDED|95.0|0.32|0.88|||Log Rank|||GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.88|0.32|0.0135
91786164|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.7||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.7
91786165|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.58||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.58
91786166|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.44||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.44
91786167|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.75||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.75
91786168|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.84||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.84
91786169|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.67||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.67
91786170|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.002||||0.99||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.99
91602313|NCT02022826|183097227|OTHER||percentage of agreement|76.0||||0.0052|TWO_SIDED|95.0|69.0|83.0|||McNemar|||||83|69|0.0052
91602314|NCT02022826|183097228|OTHER||precentage of agreement|92.0||||1|TWO_SIDED|95.0|87.0|96.0|||McNemar|||||96|87|1.00
91602315|NCT03179436|183097232|OTHER||Percent Difference|2.4|||||TWO_SIDED|95.0|-8.7|14.1|||Percent Difference|Comparision based on Miettinen \& Nurminen method||||14.1|-8.7|
91602316|NCT04025632|183097249|SUPERIORITY||Wilcoxon-Mann-Whitney odds|0.55||||0.464|TWO_SIDED|95.0|0.19|1.57||Conducted using a 2-sided Van Elteren test, which represents an extension of the Wilcoxon rank sum test for comparing 2 treatments in a stratified experiment using within-stratum ranks assigning greater weight to rank sums from smaller strata.|2-sided Van Elteren test||The magnitude of association between treatment groups was expressed as in Wilcoxon-Mann-Whitney odds followed by the 95% confidence intervals.|||1.57|0.19|0.464
91786171|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.62
91602317|NCT04025632|183097251|SUPERIORITY||Odds Ratio (OR)|1.088||||0.919|TWO_SIDED|95.0|0.214|5.535||P-value for the comparison of treatment groups was calculated using logistic regression with investigational medicinal product and strata as fixed factors.|Regression, Logistic|||||5.535|0.214|0.919
91786172|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.17||||0.36||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.36
91786173|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.003||||0.99||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.99
91790541|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.943|TWO_SIDED|95.0|-0.518|0.557||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.557|-0.518|0.943
91790542|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91602318|NCT04025632|183097252|SUPERIORITY||Least squares (LS) mean difference|-0.688||||0.496|TWO_SIDED|95.0|-2.781|1.404||Based on a linear model with treatment and strata (anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase \[HMGCR\]+/anti-signal recognition particle \[SRP\]+) as fixed factors with Baseline 3TUG as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.404|-2.781|0.496
91602319|NCT04025632|183097253|SUPERIORITY||LS mean difference|3.89||||0.431|TWO_SIDED|95.0|-6.18|13.95||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline proximal MMT as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||13.95|-6.18|0.431
91602320|NCT04025632|183097254|SUPERIORITY||LS mean difference|-0.204||||0.8|TWO_SIDED|95.0|-1.855|1.448||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Physician Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.448|-1.855|0.800
91602321|NCT04025632|183097255|SUPERIORITY||LS mean difference|-1.281||||0.221|TWO_SIDED|95.0|-3.39|0.829||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Patient Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.829|-3.390|0.221
91602322|NCT04025632|183097256|SUPERIORITY||LS mean difference|-0.147||||0.508|TWO_SIDED|95.0|-0.601|0.307||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline HAQ as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.307|-0.601|0.508
91602323|NCT04025632|183097257|SUPERIORITY||LS mean difference|-0.143||||0.765|TWO_SIDED|95.0|-1.123|0.837|||Linear Mixed Effect Model|Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline MDAAT as a covariate.|The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.837|-1.123|0.765
91602324|NCT04025632|183097258|SUPERIORITY||LS mean difference|5.53||||0.265|TWO_SIDED|95.0|-4.49|15.55||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline FACIT-Fatigue Scale as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||15.55|-4.49|0.265
91602325|NCT02216695|183097282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.3|1.4|||Regression, Logistic||This is OR for 65 to 74 years age group with \< 65 years as the reference group|||1.40|1.30|
91602326|NCT02216695|183097282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.66|1.79|||Regression, Logistic||This is OR for age group 75 to 84 years age group with \< 65 years as reference|||1.79|1.66|
91602327|NCT02216695|183097282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|1.89|2.19|||Regression, Logistic||This is OR for age group equal to greater than 85 years age group with \< 65 years as reference|||2.19|1.89|
91602328|NCT02216695|183097283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.1|1.3|||Regression, Logistic||This is the OR for 1998-2003 discharge period with 2003-08 as the reference group|||1.30|1.10|
91602329|NCT02216695|183097283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|1.07|1.18|||Regression, Logistic||This is the OR for 2008-13 discharge period with 2003-08 as the reference group|||1.18|1.07|
91602330|NCT02591615|183097284|SUPERIORITY|||||||0.2176|||||||Fisher Exact|||||||0.2176
91602331|NCT02591615|183097285|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.84|TWO_SIDED|95.0|0.67|1.64|||Log Rank|||||1.64|0.67|0.84
91786174|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.2||||0.24||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.24
91786175|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.62
91786176|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.69||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.69
91786177|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.13||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.60
91786178|NCT00488683|183452512|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.01||||0.95||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.95
91786179|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
91786180|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
91786181|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
91786182|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
91602332|NCT06062264|183097313|SUPERIORITY||Adjusted Risk Ratio|1.03|||||TWO_SIDED|95.0|1.0|1.06||||||Comparing the risk of receiving an influenza vaccination|Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|1.06|1.00|
91602333|NCT06062264|183097313|SUPERIORITY||Adjusted Risk Ratio|1.02|||||TWO_SIDED|95.0|0.99|1.06|||||Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|Comparing the risk of receiving an influenza vaccination||1.06|0.99|
91786183|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
91786184|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
91786185|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
91786186|NCT00488683|183452512|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
91786187|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.68||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.68
91786188|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.44||||0.09||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.09
91786189|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.11||||0.69||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.69
91786190|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.38||||0.2||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.20
91786191|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.88||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.88
91786192|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.12||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.12
91786193|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.25||||0.37||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.37
91786194|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.36
91602334|NCT05256888|183097316|SUPERIORITY||Slope|-1.77|STANDARD_ERROR_OF_MEAN|1.08||0.11|TWO_SIDED||||||Regression, Linear|||"In a linear model to assess group effects on fatigue at 12 weeks, adjusting for baseline levels of fatigue:~Effect of group = -1.77±1.08, p=0.11, favoring the TRE group."||||0.11
91602335|NCT05195528|183097317|SUPERIORITY||Difference in least square mean|17.1|||<|0.0001|TWO_SIDED|95.0|11.81|22.45||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.45|11.81|<0.0001
91602336|NCT05195528|183097317|SUPERIORITY||Least square mean difference|16.7|||<|0.0001|TWO_SIDED|95.0|11.36|22.04||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.04|11.36|<0.0001
91602337|NCT05195528|183097318|SUPERIORITY||Least square mean difference|15.8|||<|0.0001|TWO_SIDED|95.0|9.93|21.6||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||21.60|9.93|<0.0001
91602338|NCT05195528|183097318|SUPERIORITY||Least square mean difference|13.7|||<|0.0001|TWO_SIDED|95.0|7.84|19.54||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||19.54|7.84|<0.0001
91786195|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||
91786196|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.2||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||
91786197|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||
91786198|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.15||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||
91786199|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|1.0||||||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
91786200|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|1.0||||||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
91786201|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
91786202|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135||||
91786203|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y||||
91786204|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.79||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.79
91786205|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.35||||0.16||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.16
91786206|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.48||||0.1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.10
91786207|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.98||||0.003||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.003
91786208|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.03||||0.91||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.91
91786209|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.57||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.01
91786210|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.19||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.19
91786211|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.89||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.04
91786212|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||
91786213|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||
91786214|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.23||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||
91786215|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.96||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||
91786216|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.18||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.46
91786217|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.9||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.90
91786218|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.51||||0.008||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.008
91786219|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.42||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.08
91613692|NCT02078713|183121553|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.75|3.49||P-value calculated in multiply imputed dataset.|Regression, Logistic||OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer.|Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)||3.49|1.75|<0.0001
91786220|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.15||||0.52||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.52
91786221|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.27||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.18
91786222|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.37||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.07
91786223|NCT00488683|183452513|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.55||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.55
91786224|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||
91786225|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.0007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||
91786226|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||
91613693|NCT02078713|183121554|SUPERIORITY||Odds Ratio (OR)|1.19||||0.25|TWO_SIDED|95.0|0.88|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at baseline||1.61|0.88|0.25
91613694|NCT02078713|183121554|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5|TWO_SIDED|95.0|0.66|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at 4 months post-enrollment||1.22|0.66|0.5
91613695|NCT02078713|183121554|SUPERIORITY||Odds Ratio (OR)|0.83||||0.23|TWO_SIDED|95.0|0.6|1.13||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.||1.13|0.60|0.23
91786227|NCT00488683|183452513|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||
91786228|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45||||0.0006||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0006
91786229|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.0021||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0021
91786230|NCT00488683|183452514|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||
91786231|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.53||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination||||0.53
91786232|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.21||||0.26||95.0|||||Parametric correlation||Values from Groups 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
91786233|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.84||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.84
91786234|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Spearman Correlation Coefficient|0.22||||0.26||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
91786235|NCT00488683|183452514|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
91522863|NCT00079001|182921136|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.|Hazard Ratio (HR)|0.97||||0.385|TWO_SIDED|95.0|0.0|1.174||Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.|Log Rank||Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo|The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.||1.174|0|0.385
91522864|NCT00079001|182921137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.29|TWO_SIDED|95.0|0.7|1.12|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.12|0.70|0.29
91786236|NCT00488683|183452514|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
91786237|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.33|||<|0.001||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
91786238|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46|||<|0.001||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
91786239|NCT00488683|183452514|SUPERIORITY_OR_OTHER||R-square|0.11|||<|0.001||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
91522865|NCT00079001|182921138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.22|TWO_SIDED|95.0|0.74|1.07|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.07|0.74|0.22
91522866|NCT02618616|182921139|OTHER||least square difference|8.7||||0.8495|ONE_SIDED|90.0|8.4|||The 1-sided p-value tests if the ZPL-389 Least square (LS) mean is \< the placebo LS mean.|ANCOVA|||ANCOVA of PASI at Week 12|||8.4|0.8495
91522867|NCT02618616|182921140|OTHER||Odds Ratio (OR)|0.562||||0.9058|TWO_SIDED|90.0|0.27|1.16|||Regression, Logistic|||Logistic Regression PASI-50||1.16|0.27|0.9058
91522868|NCT02618616|182921140|OTHER||Odds Ratio (OR)|0.946||||0.5422|TWO_SIDED|90.0|0.4|2.25|||Regression, Logistic|||Logistic Regression PASI-75||2.25|0.4|0.5422
91522869|NCT05878197|182921175|OTHER|||||||0.024||||||Linear Mixed Models: time-effect|Mixed Models Analysis|||||||0.024
91522870|NCT05878197|182921175|OTHER|||||||0.822||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.822
91522871|NCT05878197|182921175|OTHER|||||||0.29||||||Linar mixed models: time\*group-effect|Mixed Models Analysis|||||||0.290
91522872|NCT05878197|182921175|OTHER||Mean Difference (Final Values)|1.8||||0.035|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.035
91522873|NCT05878197|182921175|OTHER||Mean Difference (Final Values)|1.8||||0.038|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.038
91522874|NCT05878197|182921175|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-1.9|1.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||1.9|-1.9|1.000
91522875|NCT05878197|182921176|OTHER|||||||0.107||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.107
91522876|NCT05878197|182921176|OTHER|||||||0.996||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.996
91522877|NCT05878197|182921176|OTHER|||||||0.639||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.639
91522878|NCT05878197|182921176|OTHER||Mean Difference (Final Values)|-0.1||||0.731|TWO_SIDED|95.0|-0.6|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-0.6|0.731
91522879|NCT05878197|182921176|OTHER||Mean Difference (Final Values)|-0.4||||0.217|TWO_SIDED|95.0|-1.1|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-1.1|0.217
91522880|NCT05878197|182921176|OTHER||Mean Difference (Final Values)|-0.3||||0.253|TWO_SIDED|95.0|-0.9|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-0.9|0.253
91522881|NCT05878197|182921177|OTHER|||||||0.024||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.024
91522882|NCT05878197|182921177|OTHER|||||||0.449||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.449
91522883|NCT05878197|182921177|OTHER|||||||0.786||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.786
91522884|NCT05878197|182921177|OTHER||Mean Difference (Final Values)|-3.3||||0.099|TWO_SIDED|95.0|-7.2|0.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.7|-7.2|0.099
91522885|NCT05878197|182921177|OTHER||Mean Difference (Final Values)|-3.9||||0.074|TWO_SIDED|95.0|-8.3|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-8.3|0.074
91522886|NCT05878197|182921177|OTHER||Mean Difference (Final Values)|-1.7||||0.472|TWO_SIDED|95.0|-6.7|3.2||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.2|-6.7|0.472
91522887|NCT05878197|182921178|OTHER|||||||0.115||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.115
91522888|NCT05878197|182921178|OTHER|||||||0.516||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.516
91786240|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.06||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.06
91786241|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.5|||<|0.001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||<0.001
91522889|NCT05878197|182921178|OTHER|||||||0.276||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.276
91786242|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.01
91786243|NCT00488683|183452514|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.10
91522890|NCT05878197|182921178|OTHER||Mean Difference (Final Values)|-6.5||||0.025|TWO_SIDED|95.0|-12.2|-0.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||-0.9|-12.2|0.025
91522891|NCT05878197|182921178|OTHER||Mean Difference (Final Values)|-0.7||||0.794|TWO_SIDED|95.0|-6.4|4.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||4.9|-6.4|0.794
91786244|NCT00488683|183452514|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
91522892|NCT05878197|182921178|OTHER||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.7|5.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||5.7|-7.7|0.760
91522893|NCT03421808|182921194|SUPERIORITY|||||||0.6|||||||Chi-squared|||For categorical clinical remission data we performed a chi-square test on the IIT and completer sample using Graph-Pad Prism.||||0.6
91602339|NCT01552902|183097319|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-3.4|||=|0.0013|TWO_SIDED|95.0|-5.4|-1.3|||Mixed Models Analysis|||The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.||-1.3|-5.4|= 0.0013
91786245|NCT00488683|183452514|SUPERIORITY_OR_OTHER||R-square|0.25||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
91786246|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.04||||0.7||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.70
91786247|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.63||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.63
91709484|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.57||||0.5077|TWO_SIDED|95.0|0.11|3.03|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.03|0.11|0.5077
91786248|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.74
91786249|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.74
91786250|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.05||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.05
91602340|NCT01552902|183097319|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.0|-6.0|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-6|-11|< 0.0001
91602341|NCT01552902|183097319|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.6|-2.6|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-2.6|-7.6|< 0.0001
91602342|NCT02487108|183097324|OTHER||LS Mean Difference|38.9|||<|0.001|TWO_SIDED|95.0|19.931|57.855|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||57.855|19.931|<0.001
91602343|NCT02487108|183097324|OTHER||LS Mean Difference|44.0|||<|0.001|TWO_SIDED|95.0|25.122|62.881|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||62.881|25.122|<0.001
91602344|NCT02487108|183097324|OTHER||LS Mean Difference|53.4|||<|0.001|TWO_SIDED|95.0|34.589|72.282|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||72.282|34.589|<0.001
91602345|NCT00168831|183097360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
91786251|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.36
91786252|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.11||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.18
91786253|NCT00488683|183452520|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.82||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.82
91786254|NCT00488683|183452520|SUPERIORITY_OR_OTHER||R-square|0.0013||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||
91786255|NCT00488683|183452520|SUPERIORITY_OR_OTHER||R-square|0.0014||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||
91786256|NCT00488683|183452520|SUPERIORITY_OR_OTHER||R-square|0.0008||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||
91602346|NCT00168831|183097360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
91602347|NCT00168831|183097361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.713|STANDARD_ERROR_OF_MEAN|1.052||0.0004||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0004
91602348|NCT00168831|183097361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.445|STANDARD_ERROR_OF_MEAN|1.059||0.0012||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||0.0012
91602349|NCT00168831|183097362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
91602350|NCT00168831|183097362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
91602351|NCT00168831|183097363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg vs. Placebo|||0.890|0.687|0.0002
91602352|NCT00168831|183097363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg vs. Placebo|||0.828|0.635|<0.0001
91602353|NCT00168831|183097407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91602354|NCT00168831|183097407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA||Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91602355|NCT00168831|183097408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91602356|NCT00168831|183097408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91602357|NCT00168831|183097409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91602358|NCT00168831|183097409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.393|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91602359|NCT00168831|183097410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91786257|NCT00488683|183452520|SUPERIORITY_OR_OTHER||R-square|0.0009||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||
91786258|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.34||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
91786259|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
91786260|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.09||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C||||
91786261|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
91786262|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
91786263|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
91786264|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.74||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
91786265|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.53||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
91786266|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
91786267|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
91786268|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
91786269|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
91786270|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
91786271|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.78||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
91786272|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.94||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
91786273|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.85||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
91786274|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
91786275|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
91786276|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
91524195|NCT04843930|182923533|SUPERIORITY||Mean Difference (Final Values)|2.83||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 239.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis."||||0.04
91602360|NCT00168831|183097410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91602361|NCT00168831|183097411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
91602362|NCT00168831|183097411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.1|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91602363|NCT00168831|183097412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0169||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||0.0169
91522894|NCT07069764|182921197|OTHER|"This study was not designed as a non-inferiority or equivalence trial. It was powered (80% power, α = 0.05) to detect clinically significant differences in pain reduction between 635 nm and 980 nm diode lasers, based on prior LLLT studies in TMD. Sample size was calculated before recruitment."|Effect size (Kendall's W and r)|0.75||||0.05|TWO_SIDED|95.0|0.68|0.79||P-values were adjusted using Bonferroni correction for multiple comparisons. The a priori threshold for statistical significance was set at p \< 0.05.|Friedman test, Mann-Whitney U test|Non-parametric tests were used due to non-normal data distribution (Shapiro-Wilk test). Effect size measures were also reported.||"The study was designed to compare the effects of 635 nm and 980 nm low-level laser therapy on pain and jaw function. Statistical analysis methods are described below."|"Shapiro-Wilk test was used to assess normality. Non-parametric tests were applied. Friedman test for within-group comparisons, followed by Bonferroni-adjusted post hoc tests. Mann-Whitney U test for between-group comparisons. Effect sizes were calculated using Kendall's W (within groups) and r (between groups)."|0.79|0.68|0.05
91522895|NCT03183388|182921213|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare Least Square (LS) estimate of endpoint minus baseline to zero. The best-fitting model was chosen based on information criteria.|Endpoint minus Baseline|-3.04|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-4.14|-1.93|||t-test, 2 sided|||||-1.93|-4.14|0.0001
91522896|NCT03183388|182921214|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|-1.37|STANDARD_ERROR_OF_MEAN|2.51||0.6|TWO_SIDED|95.0|-6.97|4.23|||t-test, 2 sided|||||4.23|-6.97|0.60
91522897|NCT03183388|182921215|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare LS estimate of endpoint minus baseline to zero.|Endpoint minus Baseline|0.11|STANDARD_ERROR_OF_MEAN|0.016||0.0001|TWO_SIDED|95.0|0.074|0.146|||t-test, 2 sided|||||0.146|0.074|0.0001
91522898|NCT03183388|182921216|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|0.031|STANDARD_ERROR_OF_MEAN|0.055||0.58|TWO_SIDED|95.0|-0.095|0.157|||t-test, 2 sided|||||0.157|-0.095|0.58
91522899|NCT00071721|182921234|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.958||||0.88||95.0|||||Cox Proportional Hazards|||||||0.88
91602364|NCT00168831|183097412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
91602365|NCT02522767|183097436|SUPERIORITY||Odds Ratio (OR)|1.55|||>|0.05|TWO_SIDED|95.0|0.73|3.32||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups, at a two-sided 0.05 significance level.||3.32|0.73|>0.05
91602366|NCT02522767|183097439|SUPERIORITY||Odds Ratio (OR)|1.78|||>|0.05|TWO_SIDED|95.0|0.96|3.29||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups at a two-sided 0.05 significance level.||3.29|0.96|>0.05
91786277|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
91602367|NCT02522767|183097440|SUPERIORITY||Odds Ratio (OR)|1.3|||>|0.05|TWO_SIDED|95.0|0.78|2.15|||Generalized estimating equation approach|||Proportions were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||2.15|0.78|>0.05
91602368|NCT02522767|183097441|SUPERIORITY||Hazard Ratio (HR)|1.36|||>|0.05|TWO_SIDED|95.0|0.91|2.02||The p-value was based on log-rank test.|Log Rank||Hazard ratio and its 95% CI were obtained from Cox proportional hazards model with treatment group as a factor.|Times to normal stool pattern were compared between treatment groups, at a two-sided 0.05 significance level.||2.02|0.91|>0.05
91602369|NCT02522767|183097442|SUPERIORITY||Treatment difference|-0.24|||<|0.05|TWO_SIDED|95.0|-0.41|-0.08|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||-0.08|-0.41|<0.05
91602370|NCT02522767|183097443|SUPERIORITY||Treatment difference|-2.39|||>|0.05|TWO_SIDED|95.0|-5.46|0.67|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||0.67|-5.46|>0.05
91602371|NCT02522767|183097444|SUPERIORITY||Treatment difference|-289.69|||<|0.05|TWO_SIDED|95.0|-514.96|-64.42|||ANCOVA||An ANCOVA model was used to calculate estimates.|Changes from baseline were compared between treatment groups, at a two-sided 0.05 significance level.||-64.42|-514.96|<0.05
91786278|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
91602372|NCT02522767|183097445|SUPERIORITY||Treatment difference|12.8|||<|0.05|TWO_SIDED|95.0|5.1|20.5|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimates.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||20.50|5.10|<0.05
91786279|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
91522900|NCT00803101|182921277|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|14.3|||||TWO_SIDED|95.0|2.8|25.8||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|95% confidence interval|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % participants with effective hemostasis||The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||25.8|2.8|
91522901|NCT00803101|182921278|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|45.3|||||TWO_SIDED|95.0|31.9|56.4||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|Newcombe-Wilson score method|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % pts with rapid decrease of the INR.||The analysis of rapid decrease of the INR was via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with INR ≤ 1.3 at 30 minutes after the end of infusion.||56.4|31.9|
91522902|NCT02026232|182921285|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91602373|NCT02357420|183097459|SUPERIORITY|||||||0.36|||||||Measures mixed effects model (MMRM)|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.36
91786280|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
91786281|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.28||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
91786282|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
91786283|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
91786284|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.11||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
91786285|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
91786286|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
91786287|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
91786288|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.39||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
91786289|NCT00488683|183452521|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
91786290|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.24||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
91786291|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
91786292|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.52||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
91786293|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
91602374|NCT02357420|183097459|SUPERIORITY|||||||0.25|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.25
91786294|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
91786295|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.29||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
91786296|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
91786297|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
91786298|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.7||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
91786299|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
91786300|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.5||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
91650395|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.001||95.0|-2.03|-1.0||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-1.00|-2.03|<0.001
91786301|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
91650396|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|||<|0.001||95.0|-1.73|-0.78||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Bedtime|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.78|-1.73|<0.001
91786302|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
91709485|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.74||||0.5916|TWO_SIDED|95.0|0.26|2.15|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||2.15|0.26|0.5916
91786303|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
91786304|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
91786305|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
91786306|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
91786307|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
91786308|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
91786309|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
91786310|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
91786311|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
91522903|NCT01529008|182921287|SUPERIORITY||Proportion treatment responder Differenc|-0.08||||0.539|TWO_SIDED|95.0|-0.35|0.18|||Fisher Exact||"Percentage of treatment responders in PREOB® group is 60.9% ((14/23)\*100), compared with 69.2% ((18/26)\*100) in Placebo.~Difference in percentage is -8.3 Difference in treatment responders proportion: PREOB® (0.609) - Placebo (0.692) = -0.08"|||0.18|-0.35|0.539
91522904|NCT02487498|182921288|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL|Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813||0.415|TWO_SIDED|95.0|-0.0342|-0.0023|||Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||-0.0023|-0.0342|0.415
91522905|NCT02487498|182921289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813|||TWO_SIDED|95.0|-0.0342|-0.0023||||||||-0.0023|-0.0342|
91522906|NCT02487498|182921290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0091|STANDARD_ERROR_OF_MEAN|0.01132|||TWO_SIDED|95.0|-0.0313|0.0131||||||||0.0131|-0.0313|
91522907|NCT02487498|182921291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0086|STANDARD_ERROR_OF_MEAN|0.00874|||TWO_SIDED|95.0|-0.0086|0.0258||||||||0.0258|-0.0086|
91709486|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.65||||0.332|TWO_SIDED|95.0|0.27|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.27|0.3320
91522908|NCT00755222|182921297|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
91522909|NCT00755222|182921298|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||ANOVA|||||||0.046
91522910|NCT00755222|182921299|SUPERIORITY_OR_OTHER|||||||0.164|||||||ANOVA|||||||0.164
91522911|NCT00755222|182921300|SUPERIORITY_OR_OTHER|||||||0.442|||||||ANOVA|||||||0.442
91522912|NCT00755222|182921301|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||||||0.095
91650397|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001||95.0|-0.81|-0.13||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||02 - 04 a.m.|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.13|-0.81|<0.001
91786312|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
91786313|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
91786314|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
91786315|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
91786316|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
91786317|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
91786318|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.45||||0.0436||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||0.0436
91786319|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
91786320|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
91786321|NCT00488683|183452522|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
91786322|NCT00505076|183452580|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.||||0.21
91786323|NCT00505076|183452581|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.47
91786324|NCT00505076|183452582|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.84
91786325|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-1.0|0.57||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||0.57|-1.00|
91786326|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.53|1.11||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||1.11|-0.53|
91786327|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.748|||||TWO_SIDED|95.0|-0.02|1.52||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||1.52|-0.02|
91786328|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.207|||||TWO_SIDED|95.0|-2.01|-0.41||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||-0.41|-2.01|
91786329|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.991|||||TWO_SIDED|95.0|0.18|1.81||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7 , pre-breakfast||1.81|0.18|
91786330|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.497|||||TWO_SIDED|95.0|0.66|2.34||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.34|0.66|
91786331|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.955|||||TWO_SIDED|95.0|1.16|2.75||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.75|1.16|
91786332|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-1.74|0.18||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||0.18|-1.74|
91786333|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.188|||||TWO_SIDED|95.0|-0.81|1.19||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||1.19|-0.81|
91786334|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.35|1.55||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||1.55|-0.35|
91786335|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.069|||||TWO_SIDED|95.0|-2.05|-0.08||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.08|-2.05|
91650398|NCT01123980|183193450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.001||95.0|-0.06|0.4||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast the following day|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.40|-0.06|<0.001
91650399|NCT01123980|183193451|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8583||95.0|0.64|1.46|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c less than 7% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.46|0.64|0.8583
91602375|NCT02357420|183097459|SUPERIORITY|||||||0.59|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.59
91786336|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.289|||||TWO_SIDED|95.0|-0.71|1.29||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||1.29|-0.71|
91786337|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.257|||||TWO_SIDED|95.0|0.22|2.29||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.29|0.22|
91786338|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.669|||||TWO_SIDED|95.0|0.68|2.65||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.65|0.68|
91786339|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|||||TWO_SIDED|95.0|-1.65|0.54||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||0.54|-1.65|
91602376|NCT01872338|183097475|SUPERIORITY||Incident Rate Ratio|0.5||||0.015|TWO_SIDED|95.0|0.29|0.87|||negative binomial regression|||||.87|.29|.015
91602377|NCT01872338|183097476|SUPERIORITY||Incident Rate Ratio|0.43||||0.01|TWO_SIDED|95.0|0.22|0.82|||negative binomial regression|||||.82|.22|.01
91602378|NCT01872338|183097477|SUPERIORITY|||||||0.34|||||||Regression, Linear|repeated measures, overall time by condition effect||||||.34
91786340|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.745|||||TWO_SIDED|95.0|-0.4|1.89||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||1.89|-0.40|
91786341|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.711|||||TWO_SIDED|95.0|-0.36|1.78||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.78|-0.36|
91786342|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-2.15|0.09||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||0.09|-2.15|
91786343|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.474|||||TWO_SIDED|95.0|-0.66|1.61||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||1.61|-0.66|
91786344|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.775|||||TWO_SIDED|95.0|0.6|2.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.95|0.60|
91786345|NCT01128621|183452615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.741|||||TWO_SIDED|95.0|0.63|2.86||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.86|0.63|
91786346|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195|||||TWO_SIDED|95.0|-17.17|17.56||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||17.56|-17.17|
91786347|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.863|||||TWO_SIDED|95.0|-34.7|0.98||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||0.98|-34.70|
91786348|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.46|||||TWO_SIDED|95.0|-23.04|12.12||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||12.12|-23.04|
91786349|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85|||||TWO_SIDED|95.0|-13.89|21.58||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||21.58|-13.89|
91786350|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.655|||||TWO_SIDED|95.0|-21.7|14.39||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||14.39|-21.70|
91786351|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.712|||||TWO_SIDED|95.0|-39.25|-2.17||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||-2.17|-39.25|
91786352|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.31|||||TWO_SIDED|95.0|-27.63|9.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||9.01|-27.63|
91786353|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.649|||||TWO_SIDED|95.0|-19.43|12.14||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||12.14|-19.43|
91786354|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.66|||||TWO_SIDED|95.0|-32.72|-0.6||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||-0.60|-32.72|
91786355|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.251|||||TWO_SIDED|95.0|-38.34|-6.16||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||-6.16|-38.34|
91786356|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.59|||||TWO_SIDED|95.0|-20.69|11.51||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||11.51|-20.69|
91786357|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.941|||||TWO_SIDED|95.0|-15.4|17.28||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||17.28|-15.40|
91786358|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.07|||||TWO_SIDED|95.0|-28.82|4.68||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||4.68|-28.82|
91786359|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.662|||||TWO_SIDED|95.0|-34.72|-0.6||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.60|-34.72|
91786360|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.101|||||TWO_SIDED|95.0|-44.0|5.8||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||5.80|-44.00|
91786361|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.976|||||TWO_SIDED|95.0|-53.56|-2.39||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||-2.39|-53.56|
91786362|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.609|||||TWO_SIDED|95.0|-48.82|1.6||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.60|-48.82|
91786363|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.094|||||TWO_SIDED|95.0|-22.34|28.53||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||28.53|-22.34|
91786364|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.194|||||TWO_SIDED|95.0|-48.07|3.69||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||3.69|-48.07|
91786365|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.07|||||TWO_SIDED|95.0|-57.66|-4.48||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-4.48|-57.66|
91786366|NCT01128621|183452616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.703|||||TWO_SIDED|95.0|-52.98|-0.42||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-0.42|-52.98|
91786367|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||0.50|-1.50|
91786368|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.513|||||TWO_SIDED|95.0|-0.51|1.54||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||1.54|-0.51|
91786369|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.05|2.01||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||2.01|0.05|
91786370|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.955|||||TWO_SIDED|95.0|-1.98|0.07||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||0.07|-1.98|
91786371|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.454|||||TWO_SIDED|95.0|-0.59|1.5||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||1.50|-0.59|
91709487|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1922|TWO_SIDED|95.0|0.14|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.14|0.1922
91602379|NCT01872338|183097478|SUPERIORITY|||||||0.23||||||repeated measures, overall time by condition effect|Regression, Linear|||||||.23
91602380|NCT01808612|183097483|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.264|TWO_SIDED|95.0|-0.55|2.0|||Mixed Models Analysis|||Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.||2.00|-0.55|0.264
91602381|NCT03683394|183097490|SUPERIORITY||Mean Difference (Net)|0.15||||0.008|TWO_SIDED|95.0|0.04|0.26||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.26|0.04|0.008
91602382|NCT03683394|183097491|SUPERIORITY||Mean Difference (Net)|0.11||||0.002|TWO_SIDED|95.0|0.02|0.21||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.21|0.02|0.002
91786372|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.468|||||TWO_SIDED|95.0|0.39|2.55||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||2.55|0.39|
91602383|NCT03683394|183097492|SUPERIORITY||Mean Difference (Net)|1.11||||0.03|TWO_SIDED|95.0|0.08|2.14||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||2.14|0.08|0.03
91786373|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.985|||||TWO_SIDED|95.0|0.96|3.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||3.01|0.96|
91786374|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312|||||TWO_SIDED|95.0|-1.38|0.76||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||0.76|-1.38|
91786375|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.394|||||TWO_SIDED|95.0|-0.7|1.49||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||1.49|-0.70|
91786376|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.875|||||TWO_SIDED|95.0|-0.18|1.93||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||1.93|-0.18|
91786377|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||||TWO_SIDED|95.0|-1.95|0.25||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||0.25|-1.95|
91786378|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.542|||||TWO_SIDED|95.0|-0.58|1.66||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||1.66|-0.58|
91786379|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.248|||||TWO_SIDED|95.0|0.09|2.4||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.40|0.09|
91786380|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.729|||||TWO_SIDED|95.0|0.63|2.83||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.83|0.63|
91786381|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|||||TWO_SIDED|95.0|-1.21|0.91||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||0.91|-1.21|
91786382|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.737|||||TWO_SIDED|95.0|-0.34|1.81||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||1.81|-0.34|
91786383|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.245|||||TWO_SIDED|95.0|0.21|2.28||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||2.28|0.21|
91786384|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.623|||||TWO_SIDED|95.0|-1.71|0.46||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.46|-1.71|
91786385|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.62|1.57||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||1.57|-0.62|
91786386|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.36|||||TWO_SIDED|95.0|0.23|2.49||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.49|0.23|
91786387|NCT01128621|183452619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.869|||||TWO_SIDED|95.0|0.79|2.95||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.95|0.79|
91786388|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.619|||||TWO_SIDED|95.0|-59.25|2.01||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||2.01|-59.25|
91786389|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.898|||||TWO_SIDED|95.0|-79.23|-16.56||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||-16.56|-79.23|
91786390|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.665|||||TWO_SIDED|95.0|-55.53|6.2||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||6.20|-55.53|
91786391|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.438|||||TWO_SIDED|95.0|-36.76|25.89||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||25.89|-36.76|
91786392|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.181|||||TWO_SIDED|95.0|-55.0|8.63||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||8.63|-55.00|
91786393|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.46|||||TWO_SIDED|95.0|-75.18|-9.74||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||-9.74|-75.18|
91786394|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.227|||||TWO_SIDED|95.0|-51.83|13.37||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||13.37|-51.83|
91786395|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.435|||||TWO_SIDED|95.0|-49.15|12.28||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||12.28|-49.15|
91786396|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.658|||||TWO_SIDED|95.0|-90.08|-27.24||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||-27.24|-90.08|
91786397|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.006|||||TWO_SIDED|95.0|-67.96|-6.05||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||-6.05|-67.96|
91786398|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.896|||||TWO_SIDED|95.0|-41.31|21.52||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||21.52|-41.31|
91786399|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.539|||||TWO_SIDED|95.0|-40.44|23.36||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||23.36|-40.44|
91786400|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.762|||||TWO_SIDED|95.0|-81.58|-15.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||-15.95|-81.58|
91786401|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.11|||||TWO_SIDED|95.0|-59.8|5.58||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||5.58|-59.80|
91602384|NCT03683394|183097493|SUPERIORITY||Odds Ratio (OR)|0.68||||0.52|TWO_SIDED|95.0|0.19|2.19||Adjusted for age and sex.|Fisher Exact|In an exploratory outcome, we examined incidence of a low CASI score or a diagnosis of MCI or dementia by treatment group.||||2.19|0.19|0.52
91602385|NCT04426695|183097500|SUPERIORITY||Least Square (LS) Mean Difference|-0.25||||0.0663|TWO_SIDED|95.0|-0.51|0.02||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.02|-0.51|0.0663
91602386|NCT04426695|183097500|SUPERIORITY||Least Square (LS) Mean Difference|-0.31||||0.0204||95.0|-0.57|0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.05|-0.57|0.0204
91602387|NCT04426695|183097500|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.0172|TWO_SIDED|95.0|-0.51|-0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||-0.05|-0.51|0.0172
91602388|NCT04426695|183097501|SUPERIORITY|||||||0.0431||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0431
91602389|NCT04426695|183097501|SUPERIORITY|||||||0.7975||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7975
91602390|NCT04426695|183097501|SUPERIORITY|||||||0.2048||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.2048
91650400|NCT01123980|183193452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8013||95.0|0.64|1.79|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c below or equal to 6.5% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.79|0.64|0.8013
91650401|NCT02557672|183193463|SUPERIORITY||Ratio of the Geometric Means|0.98||||0.84|TWO_SIDED|95.0|0.81|1.19|||Regression, Linear|||||1.19|0.81|0.84
91650402|NCT02557672|183193464|SUPERIORITY||Odds Ratio (OR)|0.49||||0.09|TWO_SIDED|95.0|0.22|1.11|||Regression, Logistic|||||1.11|0.22|0.09
91650403|NCT02557672|183193465|SUPERIORITY||Odds Ratio, log|0.76||||0.51|TWO_SIDED|95.0|0.33|1.73|||Regression, Logistic|||||1.73|0.33|0.51
91650404|NCT02557672|183193466|SUPERIORITY||Odds Ratio (OR)|1.39||||0.53|TWO_SIDED|95.0|0.51|3.79|||Regression, Logistic|||||3.79|0.51|0.53
91650405|NCT02557672|183193467|SUPERIORITY||Odds Ratio (OR)|0.52||||0.39|TWO_SIDED|95.0|0.12|2.3|||Regression, Logistic|||||2.30|0.12|0.39
91650406|NCT03705169|183193469|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio.|Geometric Mean Ratio|3.2|||||TWO_SIDED|95.0|1.9|5.3|||||The ratios of the geometric means (Arm A/Arm C) and the corresponding 95% CI were obtained by exponentiating the least squares mean difference and its 95% CI of the natural log-transformed data.|As dose-normalized AUC 0-12WK values were considered, participants were pooled within Arm (i.e., Arm A participants receiving 1, 3, 10, or 30 mg/kg were pooled and Arm C participants 0.3 or 1.0 mg/kg were pooled).|No comparisons were done with Arm B participants, as only two participants in that arm had available measurements such that AUC 0-12WK could be estimated.|5.3|1.9|
91650407|NCT03705169|183193470|OTHER||Mean|-0.18||||0.26|TWO_SIDED|95.0|-0.53|0.18||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 7 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.18|-0.53|0.26
91650408|NCT03705169|183193472|OTHER||Mean|-0.02||||0.78|TWO_SIDED|95.0|-0.24|0.19||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 14 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.19|-0.24|0.78
91650409|NCT00458302|183193489|NON_INFERIORITY_OR_EQUIVALENCE|The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.6|||||TWO_SIDED|95.0|-10.1|6.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.||6.8|-10.1|
91786402|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.359|||||TWO_SIDED|95.0|-48.95|8.23||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||8.23|-48.95|
91786403|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.712|||||TWO_SIDED|95.0|-82.92|-24.5||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||-24.50|-82.92|
91786404|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.552|||||TWO_SIDED|95.0|-66.24|-8.86||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||-8.86|-66.24|
91786405|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.963|||||TWO_SIDED|95.0|-37.2|21.27||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||21.27|-37.20|
91786406|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.397|||||TWO_SIDED|95.0|-42.1|17.3||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||17.30|-42.10|
91786407|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.749|||||TWO_SIDED|95.0|-76.2|-15.3||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||-15.30|-76.20|
91786408|NCT01128621|183452620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.59|||||TWO_SIDED|95.0|-59.82|0.64||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.64|-59.82|
91786409|NCT04074161|183452637|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.|Treatment difference|-9.38|||<|0.0001|TWO_SIDED|95.0|-11.97|-6.8|||ANCOVA|||||-6.80|-11.97|<0.0001
91786410|NCT03232333|183452688|SUPERIORITY||||||=|0.71|||||||t-test, 1 sided|||||||=0.71
91786411|NCT03232333|183452689|SUPERIORITY||||||=|0.63|||||||t-test, 1 sided|||||||=0.63
91786412|NCT03232333|183452690|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|||||||=.01
91786413|NCT01087736|183452694|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.89||||0.019|TWO_SIDED|95.0|0.89|0.98||We tested our Primary hypothesis with a random-intercept repeated subject negative binomial model, modeling week (baseline - week 12) as a continuous variable. All analyses were intent-to-treat and used all observations from all weeks.|negative binomial regression|||Our primary protocol-defined analysis was to examine the within-group efficacy of topiramate to reduce percent drinking days (%DD).||0.98|0.89|0.019
91786414|NCT01087736|183452694|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There were no pre hoc hypothesis regarding change within placebo group. We were only tested change within the topiramate condition.||||0.00
91786415|NCT01087736|183452694|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.38||||0.036|TWO_SIDED|95.0|0.15|0.94|||Negative binomial model|||"A secondary analysis was powered to detect a Signal or statistical trend (p\<0.10) for a difference between the topiramate and placebo condition. We compared percent drinking days per week between groups averaged over the active phase of the trial (weeks 1-12). The negative binomial model included fixed effect for week, treatment group, and the interaction between treatment group and week. We covaried for baseline %DD averages to control for prestudy and study enrollment effects."||0.94|0.15|0.036
91790543|NCT02880956|183460068|SUPERIORITY||LS Mean of Difference|0.74|STANDARD_ERROR_OF_MEAN|0.281||0.009|TWO_SIDED|95.0|0.191|1.295||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||1.295|0.191|0.009
91786416|NCT01087736|183452695|SUPERIORITY_OR_OTHER||||||<|0.026|||||||Mixed Models Analysis|||We planned to explore the efficacy of topiramate in reducing PTSD symptom severity. We used random-intercept linear mixed models to explore the efficacy for topiramate related reduction in PTSD symptomatology. We looked for an effect of week within TOP. Baseline scores for PTSD symptoms were used as covariates in group comparisons. All analyses were intent-to-treat and used all observations from all weeks.||||<0.026
91602391|NCT04426695|183097502|SUPERIORITY|||||||0.0039||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0039
91786417|NCT01087736|183452695|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There was not a pre hoc hypothesis regarding change within placebo group. We only examined within group change in the topiramate condition.||||0.00
91786418|NCT00759564|183452712|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|124.71|||||TWO_SIDED|90.0|106.57|145.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||145.94|106.57|
91602392|NCT04426695|183097502|SUPERIORITY|||||||0.2415||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2415
91602393|NCT04426695|183097502|SUPERIORITY|||||||0.0195||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0195
91602394|NCT04426695|183097503|SUPERIORITY|||||||0.0085||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0085
91602395|NCT04426695|183097503|SUPERIORITY|||||||0.9902||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9902
91602396|NCT04426695|183097503|SUPERIORITY|||||||0.1486||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.1486
91602397|NCT04426695|183097504|SUPERIORITY|||||||0.0092||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
91522913|NCT00331344|182921304|OTHER||Dose Level VIa|1.0|||||TWO_SIDED||||||||Dose level VIa (mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes, ixabepilone 30mg/m2 IV over 3 hours on day 1, pegfilgrastim 6mg SC on day 2, oral prednisone twice daily on days 1-21) was determined to be MTD, based on 1 event of DLT at VIa.|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the MTD. If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m\^2.||||
91522914|NCT02228967|182921315|OTHER||||||=|0.274||||||A priori threshold for statistical significance was 0.05|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.274
91602398|NCT04426695|183097504|SUPERIORITY|||||||0.221||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2210
91602399|NCT04426695|183097504|SUPERIORITY|||||||0.0249||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0249
91602400|NCT04426695|183097505|SUPERIORITY|||||||0.0045||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0045
91602401|NCT04426695|183097505|SUPERIORITY|||||||0.0714||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0714
91786419|NCT00759564|183452712|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|163.51|||||TWO_SIDED|90.0|139.72|191.34||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||191.34|139.72|
91786420|NCT00759564|183452712|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|58.4|||||TWO_SIDED|90.0|48.16|70.83||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||70.83|48.16|
91786421|NCT00759564|183452714|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|167.59|||||TWO_SIDED|90.0|137.27|204.61||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||204.61|137.27|
91786422|NCT00759564|183452714|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|246.76|||||TWO_SIDED|90.0|202.11|301.27||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||301.27|202.11|
91786423|NCT00759564|183452714|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|107.13|||||TWO_SIDED|90.0|88.06|130.32||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||130.32|88.06|
91786424|NCT00759564|183452715|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|168.14|||||TWO_SIDED|90.0|137.4|205.75||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||205.75|137.40|
91786425|NCT00759564|183452715|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|248.38|||||TWO_SIDED|90.0|202.98|303.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||303.94|202.98|
91786426|NCT00759564|183452715|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|110.12|||||TWO_SIDED|90.0|89.84|134.98||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||134.98|89.84|
91786427|NCT00759564|183452717|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|134.86|||||TWO_SIDED|90.0|109.88|165.52||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||165.52|109.88|
91522915|NCT02228967|182921316|OTHER||||||=|0.083|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.083
91522916|NCT02228967|182921317|OTHER||||||=|0.028|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.028
91522917|NCT02228967|182921318|OTHER||||||=|0.708|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.708
91522918|NCT02228967|182921319|OTHER||||||=|0.197||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.197
91522919|NCT02228967|182921320|OTHER||||||=|0.023||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.023
91522920|NCT02228967|182921321|OTHER||||||<|0.001||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||<0.001
91522921|NCT02228967|182921322|OTHER||||||=|0.348||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||=0.348
91522922|NCT02228967|182921323|OTHER||Mean Difference (Final Values)|0.345|STANDARD_ERROR_OF_MEAN|0.203||0.091|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.091
91522923|NCT02228967|182921324|OTHER||Mean Difference (Net)|0.393|STANDARD_ERROR_OF_MEAN|0.362||0.278|TWO_SIDED|||||A priori alpha set at 0.05|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||.278
91522924|NCT02228967|182921325|OTHER||Mean Difference (Net)|3.163|STANDARD_ERROR_OF_MEAN|1.44||0.029|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.029
91522925|NCT02228967|182921326|OTHER||Mean Difference (Net)|-0.015||||0.897|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.897
91602402|NCT04426695|183097505|SUPERIORITY|||||||0.0061||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0061
91522926|NCT02228967|182921327|OTHER|||||||0.15|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.15
91522927|NCT02228967|182921328|OTHER|||||||0.2||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.20
91602403|NCT04426695|183097506|SUPERIORITY|||||||0.0023||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0023
91602404|NCT04426695|183097506|SUPERIORITY|||||||0.3544||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3544
91709488|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4188|TWO_SIDED|95.0|0.23|1.81|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.81|0.23|0.4188
91786428|NCT00759564|183452717|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|226.28|||||TWO_SIDED|90.0|184.36|277.72||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||277.72|184.36|
91786429|NCT00759564|183452717|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|285.05|||||TWO_SIDED|90.0|221.8|366.33||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||366.33|221.80|
91602405|NCT04426695|183097506|SUPERIORITY|||||||0.0212||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0212
91602406|NCT04426695|183097512|SUPERIORITY|||||||0.0575||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0575
91602407|NCT04426695|183097512|SUPERIORITY|||||||0.3133||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3133
91602408|NCT04426695|183097512|SUPERIORITY|||||||0.0849||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0849
91602409|NCT04426695|183097513|SUPERIORITY|||||||0.2167||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2167
91602410|NCT04426695|183097513|SUPERIORITY|||||||0.4123||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4123
91786430|NCT00759564|183452719|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.31|||||TWO_SIDED|90.0|158.81|275.87||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||275.87|158.81|
91786431|NCT00759564|183452719|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.0|||||TWO_SIDED|90.0|267.83|465.25||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||465.25|267.83|
91786432|NCT00759564|183452719|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|742.68|||||TWO_SIDED|90.0|529.59|1041.5||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1041.50|529.59|
91786433|NCT00759564|183452720|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.55|||||TWO_SIDED|90.0|158.72|276.66||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||276.66|158.72|
91786434|NCT00759564|183452720|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.26|||||TWO_SIDED|90.0|267.57|466.39||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||466.39|267.57|
91786435|NCT00759564|183452720|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|735.77|||||TWO_SIDED|90.0|523.56|1034.0||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1034.00|523.56|
91786436|NCT01565343|183452749|SUPERIORITY_OR_OTHER||ICC|0.9893||||||95.0|||||ICC|||Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest values||||
91786437|NCT01565343|183452749|SUPERIORITY_OR_OTHER||ICC|0.9574||||||95.0|||||ICC|||Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest values||||
91786438|NCT01565343|183452749|SUPERIORITY_OR_OTHER||Mean % difference|2.35|STANDARD_DEVIATION|1.413||||95.0||||||||Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values||||
91786439|NCT01565343|183452749|SUPERIORITY_OR_OTHER||Mean % difference|1.49|STANDARD_DEVIATION|0.839||||95.0||||||||Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values||||
91786440|NCT02059291|183452756|SUPERIORITY||||||<|0.0001|||||||Fisher's exact test|||||||<0.0001
91786441|NCT02059291|183452756|SUPERIORITY|||||||0.002|||||||Fisher's exact test|||||||0.0020
91786442|NCT02059291|183452756|SUPERIORITY|||||||0.005|||||||Fisher's exact test|||||||0.0050
91786443|NCT02059291|183452757|SUPERIORITY||Odds Ratio (OR)|16.96|||<|0.0001|TWO_SIDED|95.0|4.15|69.21|||Regression, Logistic|||||69.21|4.15|<0.0001
91786444|NCT02059291|183452757|SUPERIORITY||Odds Ratio (OR)|13.63||||0.0006|TWO_SIDED|95.0|2.83|65.59|||Regression, Logistic|||||65.59|2.83|0.0006
91786445|NCT02059291|183452757|SUPERIORITY||Odds Ratio (OR)|23.79||||0.0028|TWO_SIDED|95.0|2.52|224.86|||Regression, Logistic|||||224.86|2.52|0.0028
91786446|NCT02059291|183452758|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.0001|TWO_SIDED|95.0|5.86|151.31|||Regression, Logistic|||||151.31|5.86|<0.0001
91786447|NCT02059291|183452758|SUPERIORITY||Odds Ratio (OR)|12.71||||0.001|TWO_SIDED|95.0|2.53|63.89|||Regression, Logistic|||||63.89|2.53|0.0010
91786448|NCT02059291|183452758|SUPERIORITY||Odds Ratio (OR)|6.64||||0.0149|TWO_SIDED|95.0|1.2|36.57|||Regression, Logistic|||||36.57|1.20|0.0149
91786449|NCT02059291|183452759|SUPERIORITY||Odds Ratio (OR)|17.46||||0.0286|TWO_SIDED|95.0|0.92|332.92|||Regression, Logistic|||||332.92|0.92|0.0286
91602411|NCT04426695|183097513|SUPERIORITY|||||||0.2206||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2206
91602412|NCT04426695|183097514|SUPERIORITY|||||||0.0383||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0383
91602413|NCT04426695|183097514|SUPERIORITY|||||||0.3296||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3296
91602414|NCT04426695|183097514|SUPERIORITY|||||||0.0766||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0766
91786450|NCT02059291|183452759|SUPERIORITY||Odds Ratio (OR)|5.26||||0.0778|TWO_SIDED|95.0|0.53|51.97|||Regression, Logistic|||||51.97|0.53|0.0778
91786451|NCT02059291|183452759|SUPERIORITY||Odds Ratio (OR)|16.69||||0.0235|TWO_SIDED|95.0|1.04|268.5|||Regression, Logistic|||||268.50|1.04|0.0235
91786452|NCT02059291|183452760|SUPERIORITY||Odds Ratio (OR)|8.17||||0.0513|TWO_SIDED|95.0|0.75|113.44|||Regression, Logistic|||||113.44|0.75|0.0513
91786453|NCT02059291|183452760|SUPERIORITY||Odds Ratio (OR)|6.0||||0.2168|TWO_SIDED|95.0|0.27|366.24|||Regression, Logistic|||||366.24|0.27|0.2168
91522928|NCT02228967|182921329|OTHER|||||||0.38||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.38
91602415|NCT04426695|183097515|SUPERIORITY|||||||0.007||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0070
91602416|NCT04426695|183097515|SUPERIORITY|||||||0.0507||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0507
91602417|NCT04426695|183097515|SUPERIORITY|||||||0.0051||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0051
91602418|NCT04426695|183097516|SUPERIORITY|||||||0.0174||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0174
91602419|NCT04426695|183097516|SUPERIORITY|||||||0.29||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2900
91602420|NCT04426695|183097516|SUPERIORITY|||||||0.0454||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0454
91786454|NCT02059291|183452760|SUPERIORITY||Odds Ratio (OR)|4.5||||0.3571|TWO_SIDED|95.0|0.15|313.49|||Regression, Logistic|||||313.49|0.15|0.3571
91786455|NCT02673541|183452762|OTHER|||||||1|||||||Fisher Exact|||||||1
91786456|NCT05408637|183452767|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between stimulation (Active vs Sham).|Mean Difference (Final Values)|54.75|||||TWO_SIDED||||||||Difference = Active - Sham|||||
91786457|NCT05408637|183452767|OTHER||Percent Difference|0.85|||||TWO_SIDED||||||||Difference = Active - Sham|The small sample size did not allow for statistical tests. Therefore, we looked at percent difference between stimulation (Active vs Sham).||||
91786458|NCT05408637|183452767|OTHER||Cohen's d|0.07|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between Active and Sham using Cohen's d.||||
91786459|NCT05408637|183452768|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between active stimulation timepoints (Day 1 vs Day 5).|Mean Difference (Final Values)|224.8392|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|||||
91522929|NCT02228967|182921330|OTHER|A priori alpha set at 0.05||||||0.48|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.48
91786460|NCT05408637|183452768|OTHER||Percent Difference|4.35|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|The small sample size did not allow for statistical tests. Therefore, we calculated percent difference between active stimulation timepoints (Day 1 vs Day 5).||||
91786461|NCT05408637|183452768|OTHER||Cohen's d|0.36|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between active stimulation timepoints (Day 1 vs Day 5) using Cohen's d.||||
91786462|NCT05408637|183452769|OTHER||rank biserial correlation coefficient|0.767||||0.15|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed-rank test was used to evaluate changes in the IGT at Baseline vs Day 5 due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.||||0.15
91786463|NCT05408637|183452769|OTHER|The Friedman test was used to assess overall differences in IGT across Baseline, Day 1, and Day 5.||||||0.038|||||||Friedman test|||||||0.038
91786464|NCT05408637|183452769|OTHER|The Friedman test was used to assess overall differences in IGT across all timepoints (Baseline, Day 1, Day 5, Follow-Up).||||||0.043|||||||Friedman test|||||||0.043
91786465|NCT05408637|183452769|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BIS across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.134||||0.42|TWO_SIDED||||||Wilcoxon signed rank test|BIS across timepoints||||||0.42
91786466|NCT05408637|183452769|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BRIEF-A across timepoints due to the small sample size and distributional assumptions.||||||0.232|||||||Wilcoxon signed rank test|BRIEF-A across timepoints||||||0.232
91786467|NCT05408637|183452769|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Impulsivity across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.575||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|i7 Impulsivity||||||0.06
91786468|NCT05408637|183452769|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Venturesomeness across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.275||||0.36|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.36
91786469|NCT05408637|183452770|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Day 5 due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.12||||0.6|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.6
91786470|NCT05408637|183452770|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Follow Up due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.24||||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2
91602421|NCT04426695|183097517|SUPERIORITY|||||||0.004||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0040
91602422|NCT04426695|183097517|SUPERIORITY|||||||0.0413||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0413
91602423|NCT04426695|183097517|SUPERIORITY|||||||0.0032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0032
91602424|NCT04426695|183097518|SUPERIORITY|||||||0.0105||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0105
91602425|NCT04426695|183097518|SUPERIORITY|||||||0.0622||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0622
91602426|NCT04426695|183097518|SUPERIORITY|||||||0.0088||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0088
91602427|NCT04426695|183097519|SUPERIORITY|||||||0.0275||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0275
91602428|NCT04426695|183097519|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
91602429|NCT04426695|183097519|SUPERIORITY|||||||0.0072||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0072
91786471|NCT04975438|183452771|OTHER||Posterior Median Difference|-33.21|||||TWO_SIDED|95.0|-50.96|-14.84|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis under the hypothetical strategy using an informative prior (robust MAP prior).|||-14.84|-50.96|
91786472|NCT04975438|183452772|OTHER||Posterior Median Difference|-9.68|||||TWO_SIDED|95.0|-15.7|-3.6|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis with vague priors and adjusting for baseline EASI.|||-3.60|-15.70|
91522930|NCT02228967|182921331|OTHER|A priori alpha set at 0.05.||||||0.09|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.09
91522931|NCT02228967|182921332|OTHER|||||||0.08|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.08
91522932|NCT02228967|182921333|OTHER|||||||0.11|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.11
91522933|NCT02228967|182921334|OTHER|||||||0.84|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.84
91522934|NCT02466646|182921346|OTHER||Mean Difference (Net)|0.3|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||<0.01
91522935|NCT02466646|182921347|OTHER||Mean Difference (Net)|2.0|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was P=0.05|Kruskal-Wallis|||||||>0.05
91522936|NCT02466646|182921348|OTHER|||||||0.229||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.229
91522937|NCT02466646|182921349|OTHER|||||||0.28||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.280
91522938|NCT02466646|182921350|OTHER|||||||0.712|||||||Kruskal-Wallis|Threshold for statistical significance is p=0.05.||||||0.712
91522939|NCT02466646|182921351|OTHER|||||||0.674||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.674
91522940|NCT02466646|182921352|OTHER||Mean Difference (Net)|30.0||||0.006|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||0.006
91786473|NCT02693132|183452785|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91522941|NCT02466646|182921353|OTHER||Mean Difference (Net)|0.5||||0.373|TWO_SIDED||||||Kruskal-Wallis|||||||0.373
91522942|NCT02466646|182921354|OTHER||Mean Difference (Net)|0.6||||0.528|TWO_SIDED||||||Kruskal-Wallis|||||||0.528
91522943|NCT02466646|182921355|OTHER||Mean Difference (Net)|1.0||||0.208|TWO_SIDED||||||Kruskal-Wallis|||||||0.208
91522944|NCT02466646|182921356|OTHER|||||||0.051|||||||Kruskal-Wallis|||||||0.051
91522945|NCT02466646|182921357|OTHER|||||||0.647||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.647
91522946|NCT03261271|182921358|SUPERIORITY|||||||0.6489||||||P value less than 0.05 was considered statistically significant.|Mixed Models Analysis|||||||0.6489
91522947|NCT03261271|182921359|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
91522948|NCT03261271|182921360|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91522949|NCT03261271|182921361|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91522950|NCT03261271|182921362|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||Difference between groups from Baseline to Study End.||||0.09
91522951|NCT03261271|182921362|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Difference between groups from baseline to pre-surgery.||||0.04
91522952|NCT02173054|182921363|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to compare number of participants who had erythema among 3 groups.|Kruskal-Wallis|||||||0.001
91522953|NCT02173054|182921363|SUPERIORITY_OR_OTHER|||||||0.016||||||This statistical analysis was used to compare number of participants who had dryness among 3 groups|Kruskal-Wallis|||||||0.016
91522954|NCT02173054|182921363|SUPERIORITY_OR_OTHER|||||||0.025||||||This statistical analysis was used to compare number of participants who had scaling among 3 groups.|Kruskal-Wallis|||||||0.025
91522955|NCT02173054|182921363|SUPERIORITY_OR_OTHER|||||||0.571||||||This statistical analysis was used to compare number of participants who had stinging among 3 groups.|Kruskal-Wallis|||||||0.571
91522956|NCT02173054|182921363|SUPERIORITY_OR_OTHER|||||||0.449||||||This statistical analysis was used to compare number of participants who had pruritus among 3 groups.|Kruskal-Wallis|||||||0.449
91522957|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.059||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.059
91522958|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.697||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.697
91786474|NCT02693132|183452786|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91786475|NCT02693132|183452787|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91786476|NCT02693132|183452788|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91786477|NCT02693132|183452789|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91786478|NCT01168986|183452791|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
91786479|NCT01168986|183452792|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
91786480|NCT01168986|183452793|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Mixed Models Analysis|||||||0.87
91786481|NCT01168986|183452794|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
91786482|NCT03116152|183452852|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.032|TWO_SIDED|95.0|0.504|0.972|||Log Rank|||||0.972|0.504|0.032
91786483|NCT03116152|183452853|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.979|TWO_SIDED|95.0|0.722|1.391|||Log Rank|||||1.391|0.722|0.979
91786484|NCT03116152|183452854|SUPERIORITY||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-2.2|15.4||||||||15.4|-2.2|
91786485|NCT03116152|183452855|SUPERIORITY|||||||0.345|||||||Log Rank|||||||0.345
91786486|NCT01215097|183452964|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.34|||ANCOVA|||||-0.34|-0.70|<0.0001
91786487|NCT01215097|183452965|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.433|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.555|-0.311|||ANCOVA|||||-0.311|-0.555|<0.0001
91786488|NCT01215097|183452966|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.591|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001||95.0|-0.752|-0.43|||ANCOVA|||||-0.43|-0.752|<0.0001
91786489|NCT01215097|183452967|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.35|||ANCOVA|||||-0.35|-0.70|<0.0001
91786490|NCT01215097|183452968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.32|||ANCOVA|||||-0.32|-0.71|<0.0001
91786491|NCT01215097|183452969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|4.2||0.0233||95.0|-17.8|-1.3|||ANCOVA|||||-1.3|-17.8|0.0233
91786492|NCT01215097|183452970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.1|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001||95.0|-28.7|-15.6|||ANCOVA|||||-15.6|-28.7|<0.0001
91786493|NCT01215097|183452971|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|3.6||0.005||95.0|-17.3|-3.1|||ANCOVA|||||-3.1|-17.3|0.0050
91786494|NCT01215097|183452972|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.0||0.0044||95.0|-19.5|-3.6|||ANCOVA|||||-3.6|-19.5|0.0044
91602430|NCT04426695|183097520|SUPERIORITY|||||||0.1032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1032
91602431|NCT04426695|183097520|SUPERIORITY|||||||0.335||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3350
91602432|NCT04426695|183097520|SUPERIORITY|||||||0.1314||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1314
91602433|NCT04426695|183097521|SUPERIORITY|||||||0.00024||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.00024
91602434|NCT04426695|183097521|SUPERIORITY|||||||0.0054||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0054
91602435|NCT04426695|183097521|SUPERIORITY|||||||0.0005||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0005
91786495|NCT01215097|183452974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.243|||<|0.0001||95.0|2.831|13.769|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>=7.0%||13.769|2.831|<0.0001
91786496|NCT01215097|183452976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97||||0.0129||95.0|1.404|17.592|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||17.592|1.404|0.0129
91522959|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.028||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.028
91786497|NCT01215097|183452977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.054|||<|0.0001||95.0|1.799|5.185|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with HbA1c at least lowering 0.5% from baseline||5.185|1.799|<0.0001
91786498|NCT01818752|183452978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.159|TWO_SIDED|95.0|0.746|1.101||The p-value boundary for PFS analysis was 0.02141.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.||1.101|0.746|0.1590
91786499|NCT01818752|183452979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.211||||0.8934|TWO_SIDED|95.0|0.896|1.637||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.637|0.896|0.8934
91602436|NCT04426695|183097528|SUPERIORITY|||||||0.0533||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0533
91602437|NCT04426695|183097528|SUPERIORITY|||||||0.0411||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0411
91602438|NCT04426695|183097528|SUPERIORITY|||||||0.0229||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0229
91602439|NCT04426695|183097529|SUPERIORITY|||||||0.0218|||||||Stratified Log Rank Test|||||||0.0218
91602440|NCT04426695|183097529|SUPERIORITY|||||||0.0156|||||||Stratified Log Rank Test|||||||0.0156
91602441|NCT04426695|183097529|SUPERIORITY|||||||0.0067|||||||Stratified Log Rank Test|||||||0.0067
91602442|NCT04426695|183097533|SUPERIORITY|||||||0.2162||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2162
91602443|NCT04426695|183097533|SUPERIORITY|||||||0.8783||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8783
91790544|NCT02880956|183460068|SUPERIORITY||Effect size/pooled SD|-0.38|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790545|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.138||0.325|TWO_SIDED|95.0|-0.408|0.136||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.136|-0.408|0.325
91790546|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790547|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.137||0.966|TWO_SIDED|95.0|-0.274|0.263||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.263|-0.274|0.966
91790548|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790549|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.695|TWO_SIDED|95.0|-0.33|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.220|-0.330|0.695
91790550|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790551|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.145||0.662|TWO_SIDED|95.0|-0.348|0.221||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.221|-0.348|0.662
91790552|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790553|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141||0.849|TWO_SIDED|95.0|-0.25|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.304|-0.250|0.849
91790554|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790555|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.145||0.995|TWO_SIDED|95.0|-0.286|0.284||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.284|-0.286|0.995
91650410|NCT00458302|183193490|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.0|||||TWO_SIDED|95.0|-9.9|7.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.||7.8|-9.9|
91650411|NCT00458302|183193492|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.29|||||TWO_SIDED|95.0|-7.99|10.58|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|||10.58|-7.99|
91786500|NCT01818752|183452980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.412||||0.0218|TWO_SIDED|95.0|1.01|1.973||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.973|1.010|0.0218
91522960|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
91650412|NCT02661126|183193502|OTHER|Geometric least-squares mean ratio (GMR) of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.4|2.92||||||||2.92|1.40|
91786501|NCT01818752|183452981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.1388|TWO_SIDED|95.0|0.875|1.589||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.589|0.875|0.1388
91602444|NCT04426695|183097533|SUPERIORITY|||||||0.5583||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5583
91602445|NCT04426695|183097533|SUPERIORITY|||||||0.7189||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7189
91602446|NCT04426695|183097533|SUPERIORITY|||||||0.0429||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0429
91602447|NCT04426695|183097533|SUPERIORITY|||||||0.2103||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2103
91650413|NCT02661126|183193503|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.0|||||TWO_SIDED|90.0|1.39|2.89||||||||2.89|1.39|
91650414|NCT02661126|183193504|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.39|2.92||||||||2.92|1.39|
91650415|NCT02661126|183193505|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.92|||||TWO_SIDED|90.0|1.35|2.74||||||||2.74|1.35|
91650416|NCT02661126|183193511|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
91522961|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.755||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.755
91602448|NCT04426695|183097534|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
91602449|NCT04426695|183097534|SUPERIORITY|||||||0.1256||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1256
91650417|NCT02661126|183193512|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.5|2.74||||||||2.74|1.50|
91602450|NCT04426695|183097534|SUPERIORITY|||||||0.023||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0230
91602451|NCT04426695|183097534|SUPERIORITY|||||||0.1298||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1298
91602452|NCT04426695|183097534|SUPERIORITY|||||||0.2642||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2642
91602453|NCT04426695|183097534|SUPERIORITY|||||||0.097||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0970
91602454|NCT04426695|183097535|SUPERIORITY|||||||0.0147||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0147
91602455|NCT04426695|183097535|SUPERIORITY|||||||0.0669||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0669
91602456|NCT04426695|183097535|SUPERIORITY|||||||0.0094||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0094
91602457|NCT04426695|183097535|SUPERIORITY|||||||0.1306||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1306
91602458|NCT04426695|183097535|SUPERIORITY|||||||0.3576||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3576
91522962|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.003||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.003
91602459|NCT04426695|183097535|SUPERIORITY|||||||0.1476||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1476
91602460|NCT04426695|183097536|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
91602461|NCT04426695|183097536|SUPERIORITY|||||||0.0535||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0535
91602462|NCT04426695|183097536|SUPERIORITY|||||||0.0199||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0199
91786502|NCT01818752|183452982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.048|||<|0.0001|TWO_SIDED|95.0|0.026|0.088||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Pearson Chi-Square test||Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.|||0.088|0.026|< 0.0001
91786503|NCT01818752|183452983|SUPERIORITY_OR_OTHER||Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|0.773|<|0.0001|TWO_SIDED|95.0|3.48|6.51||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Mixed Effects Model for Repeated Measure|||Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.||6.51|3.48|< 0.0001
91786504|NCT02872285|183453021|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.2205|TWO_SIDED|95.0|-33.793|8.199||ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.|ANCOVA|||Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.||8.199|-33.793|0.2205
91786505|NCT02872285|183453022|SUPERIORITY|||||||0.4712|||||||Chi-squared|2-sided p-value.||||||0.4712
91786506|NCT02872285|183453023|SUPERIORITY||Mean Difference (Final Values)|-5.34||||0.6695|TWO_SIDED|95.0|-30.87|20.18|||ANCOVA|||||20.18|-30.87|0.6695
91602463|NCT04426695|183097536|SUPERIORITY|||||||0.2784||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2784
91602464|NCT04426695|183097536|SUPERIORITY|||||||0.251||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2510
91786507|NCT02872285|183453024|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
91786508|NCT02872285|183453025|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
91786509|NCT01065454|183453117|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.71||||0.1044|TWO_SIDED|95.0|-5.99|0.057||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||0.057|-5.99|0.1044
91786510|NCT01065454|183453117|SUPERIORITY_OR_OTHER_LEGACY||LSMEANS Difference|-1.38||||0.5292|TWO_SIDED|95.0|-5.71|2.94||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||2.94|-5.71|0.5292
91786511|NCT01065454|183453117|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.51||||0.0278|TWO_SIDED|95.0|-8.52|-0.5||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||-0.50|-8.52|0.0278
91786512|NCT01065454|183453117|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.8||||0.3821|TWO_SIDED|95.0|-2.25|5.84||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||5.84|-2.25|0.3821
91786513|NCT01065454|183453117|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|3.13||||0.2084|TWO_SIDED|95.0|-1.76|8.02||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||8.02|-1.76|0.2084
91786514|NCT01065454|183453117|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.33||||0.5442|TWO_SIDED|95.0|-5.66|3.0||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||3.00|-5.66|0.5442
91786515|NCT01065454|183453118|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.87|||||TWO_SIDED|95.0|-0.83|4.56||||||||4.56|-0.83|
91786516|NCT01065454|183453118|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-3.12|3.51||||||||3.51|-3.12|
91786517|NCT01065454|183453118|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.23|||||TWO_SIDED|95.0|-3.31|3.77||||||||3.77|-3.31|
91786518|NCT01065454|183453119|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-46.59|||||TWO_SIDED|95.0|-89.4|-3.8||||||||-3.8|-89.4|
91786519|NCT01065454|183453119|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-32.26|||||TWO_SIDED|95.0|-84.9|20.4||||||||20.4|-84.9|
91786520|NCT01065454|183453119|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-26.52|||||TWO_SIDED|95.0|-83.0|30.0||||||||30.0|-83.0|
91602465|NCT04426695|183097536|SUPERIORITY|||||||0.1702||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1702
91602466|NCT04426695|183097537|SUPERIORITY|||||||0.05||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0500
91786521|NCT01065454|183453120|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-89.17|||||TWO_SIDED|95.0|-172.9|5.5||||||||5.5|-172.9|
91786522|NCT01065454|183453120|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-58.22|||||TWO_SIDED|95.0|-162.1|45.6||||||||45.6|-162.1|
91786523|NCT01065454|183453120|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-43.22|||||TWO_SIDED|95.0|-153.7|67.1||||||||67.1|-153.7|
91786524|NCT01065454|183453121|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-239.31|||||TWO_SIDED|95.0|-363.4|-115.3||||||||-115.3|-363.4|
91786525|NCT01065454|183453121|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-120.89|||||TWO_SIDED|95.0|-274.4|32.6||||||||32.6|-274.4|
91786526|NCT01065454|183453121|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-25.54|||||TWO_SIDED|95.0|-189.3|138.2||||||||138.2|-189.3|
91786527|NCT01065454|183453122|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-446.49|||||TWO_SIDED|95.0|-687.4|-205.6||||||||-205.6|-687.4|
91786528|NCT01065454|183453122|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-231.57|||||TWO_SIDED|95.0|-530.4|67.2||||||||67.2|-530.4|
91602467|NCT04426695|183097537|SUPERIORITY|||||||0.0663||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0663
91602468|NCT04426695|183097537|SUPERIORITY|||||||0.0229||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0229
91786529|NCT01065454|183453122|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-34.97|||||TWO_SIDED|95.0|-353.7|283.7||||||||283.7|-353.7|
91602469|NCT04426695|183097537|SUPERIORITY|||||||0.0208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0208
91786530|NCT01065454|183453123|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.27|||||TWO_SIDED|95.0|-3.1|0.5||||||||0.5|-3.1|
91786531|NCT01065454|183453123|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.88|||||TWO_SIDED|95.0|-3.1|1.3||||||||1.3|-3.1|
91786532|NCT01065454|183453123|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.84|||||TWO_SIDED|95.0|-3.2|1.5||||||||1.5|-3.2|
91786533|NCT01065454|183453124|SUPERIORITY_OR_OTHER_LEGACY||LSS-MEANS Difference|-2.07|||||TWO_SIDED|95.0|-5.0|0.8||||||||0.8|-5.0|
91786534|NCT01065454|183453124|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS|1.39|||||TWO_SIDED|95.0|-2.1|4.9||||||||4.9|-2.1|
91786535|NCT01065454|183453124|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-1.13|||||TWO_SIDED|95.0|-4.9|2.7||||||||2.7|-4.9|
91786536|NCT01065454|183453125|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-0.58|1.14||||||||1.14|-0.58|
91786537|NCT01065454|183453125|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.82|||||TWO_SIDED|95.0|-0.23|1.87||||||||1.87|-0.23|
91786538|NCT01065454|183453125|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.03|||||TWO_SIDED|95.0|-1.11|1.06||||||||1.06|-1.11|
91786539|NCT01065454|183453126|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-3.84|||||TWO_SIDED|95.0|-8.76|1.09||||||||1.09|-8.76|
91786540|NCT01065454|183453126|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANs Difference|-0.02|||||TWO_SIDED|95.0|-6.05|6.01||||||||6.01|-6.05|
91786541|NCT01065454|183453126|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.43|||||TWO_SIDED|95.0|-8.93|4.06||||||||4.06|-8.93|
91786542|NCT01065454|183453127|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.51|||||TWO_SIDED|95.0|-0.21|1.24||||||||1.24|-0.21|
91786543|NCT01065454|183453127|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|0.81|||||TWO_SIDED|95.0|-0.07|1.69||||||||1.69|-0.07|
91786544|NCT01065454|183453127|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-0.74|1.15||||||||1.15|-0.74|
91786545|NCT01065454|183453128|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.06|||||TWO_SIDED|95.0|-17.33|7.22||||||||7.22|-17.33|
91786546|NCT01065454|183453128|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-14.55|15.11||||||||15.11|-14.55|
91786547|NCT01065454|183453128|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.18|||||TWO_SIDED|95.0|-21.05|10.69||||||||10.69|-21.05|
91786548|NCT01065454|183453129|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-4.27|||||TWO_SIDED|95.0|-21.13|12.6||||||||12.60|-21.13|
91786549|NCT01065454|183453129|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|2.78|||||TWO_SIDED|95.0|-17.59|23.16||||||||23.16|-17.59|
91786550|NCT01065454|183453129|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.61|||||TWO_SIDED|95.0|-26.43|17.2||||||||17.20|-26.43|
91786551|NCT01065454|183453130|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|5.29|||||TWO_SIDED|95.0|-7.38|17.95||||||||17.95|-7.38|
91786552|NCT01065454|183453130|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|6.47|||||TWO_SIDED|95.0|-9.79|22.73||||||||22.73|-9.79|
91786553|NCT01065454|183453130|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.35|||||TWO_SIDED|95.0|-6.14|26.84||||||||26.84|-6.14|
91786554|NCT01065454|183453131|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.15|||||TWO_SIDED|95.0|-0.55|0.24||||||||0.24|-0.55|
91786555|NCT01065454|183453131|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.17|||||TWO_SIDED|95.0|-0.34|0.67||||||||0.67|-0.34|
91786556|NCT01065454|183453131|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.06|||||TWO_SIDED|95.0|-0.45|0.56||||||||0.56|-0.45|
91786557|NCT01065454|183453132|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.17|||||TWO_SIDED|95.0|-18.48|38.81||||||||38.81|-18.48|
91786558|NCT01065454|183453132|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|7.92|||||TWO_SIDED|95.0|-26.76|42.59||||||||42.59|-26.76|
91786559|NCT01065454|183453132|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.15|||||TWO_SIDED|95.0|-44.08|31.78||||||||31.78|-44.08|
91786560|NCT01065454|183453134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.62|||||TWO_SIDED|95.0|-13.36|14.61||||||||14.61|-13.36|
91786561|NCT01065454|183453134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.46|||||TWO_SIDED|95.0|-24.32|5.39||||||||5.39|-24.32|
91602470|NCT04426695|183097537|SUPERIORITY|||||||0.0388||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0388
91522963|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.205||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.205
91602471|NCT04426695|183097537|SUPERIORITY|||||||0.0092||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
91602472|NCT04426695|183097541|SUPERIORITY|||||||0.037|||||||stratified log-rank test|||||||0.0370
91602473|NCT04426695|183097541|SUPERIORITY|||||||0.1596|||||||stratified log-rank test|||||||0.1596
91602474|NCT04426695|183097541|SUPERIORITY|||||||0.0444|||||||stratified log-rank test|||||||0.0444
91602475|NCT04426695|183097541|SUPERIORITY|||||||0.1802|||||||stratified log-rank test|||||||0.1802
91602476|NCT04426695|183097541|SUPERIORITY|||||||0.0407|||||||stratified log-rank test|||||||0.0407
91602477|NCT04426695|183097541|SUPERIORITY|||||||0.0523|||||||stratified log-rank test|||||||0.0523
91602478|NCT04426695|183097542|SUPERIORITY|||||||0.0245|||||||ANCOVA|||||||0.0245
91602479|NCT04426695|183097542|SUPERIORITY|||||||0.0554|||||||ANCOVA|||||||0.0554
91602480|NCT04426695|183097542|SUPERIORITY|||||||0.0179|||||||ANCOVA|||||||0.0179
91602481|NCT04426695|183097542|SUPERIORITY|||||||0.0035|||||||ANCOVA|||||||0.0035
91602482|NCT04426695|183097542|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
91602483|NCT04426695|183097542|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
91602484|NCT04426695|183097543|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||0.0013
91602485|NCT04426695|183097543|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.0010
91602486|NCT04426695|183097543|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
91602487|NCT04426695|183097543|SUPERIORITY|||||||0.025|||||||ANCOVA|||||||0.0250
91602488|NCT04426695|183097543|SUPERIORITY|||||||0.0012|||||||ANCOVA|||||||0.0012
91602489|NCT04426695|183097543|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
91602490|NCT04426695|183097544|SUPERIORITY|||||||0.0623|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0623
91602491|NCT04426695|183097544|SUPERIORITY|||||||0.0203|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0203
91602492|NCT04426695|183097544|SUPERIORITY|||||||0.0193|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0193
91602493|NCT04426695|183097544|SUPERIORITY|||||||0.1206|||||||MMRM|||Difference vs. Placebo by Day 29||||0.1206
91602494|NCT04426695|183097544|SUPERIORITY|||||||0.0911|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0911
91602495|NCT04426695|183097544|SUPERIORITY|||||||0.0645|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0645
91602496|NCT04426695|183097545|SUPERIORITY|||||||0.0623|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0623
91602497|NCT04426695|183097545|SUPERIORITY|||||||0.0203|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0203
91602498|NCT04426695|183097545|SUPERIORITY|||||||0.0193|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0193
91602499|NCT04426695|183097545|SUPERIORITY|||||||0.1206|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.1206
91602500|NCT04426695|183097545|SUPERIORITY|||||||0.0911|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0911
91602501|NCT04426695|183097545|SUPERIORITY|||||||0.0645|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0645
91650418|NCT02661126|183193513|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.72|||||TWO_SIDED|90.0|1.15|2.56||||||||2.56|1.15|
91650419|NCT02661126|183193514|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.85|||||TWO_SIDED|90.0|1.2|2.87||||||||2.87|1.20|
91650420|NCT02661126|183193515|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|2.03|||||TWO_SIDED|90.0|1.38|2.97||||||||2.97|1.38|
91650421|NCT02661126|183193519|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.91|||||TWO_SIDED|90.0|1.44|2.53||||||||2.53|1.44|
91650422|NCT02661126|183193520|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.97|||||TWO_SIDED|90.0|1.48|2.63||||||||2.63|1.48|
91786562|NCT01065454|183453134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.07|||||TWO_SIDED|95.0|-22.26|10.13||||||||10.13|-22.26|
91786563|NCT01065454|183453136|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.03|||||TWO_SIDED|95.0|-0.04|0.1||||||||0.10|-0.04|
91786564|NCT01065454|183453136|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.01|||||TWO_SIDED|95.0|-0.07|0.09||||||||0.09|-0.07|
91786565|NCT01065454|183453136|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.02|||||TWO_SIDED|95.0|-0.07|0.11||||||||0.11|-0.07|
91786566|NCT01065454|183453137|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.8|||||TWO_SIDED|95.0|-12.81|-0.78||||||||-0.78|-12.81|
91786567|NCT01065454|183453137|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.81|||||TWO_SIDED|95.0|-13.96|0.35||||||||0.35|-13.96|
91786568|NCT01065454|183453137|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-7.5|||||TWO_SIDED|95.0|-15.29|0.28||||||||0.28|-15.29|
91786569|NCT01065454|183453138|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-24.62|||||TWO_SIDED|95.0|-117.58|68.33||||||||68.33|-117.58|
91786570|NCT01065454|183453138|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-53.29|||||TWO_SIDED|95.0|-162.46|55.88||||||||55.88|-162.46|
91786571|NCT01065454|183453138|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-8.36|||||TWO_SIDED|95.0|-135.78|119.06||||||||119.06|-135.78|
91786572|NCT01065454|183453139|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-407.34|||||TWO_SIDED|95.0|-1055.23|240.54||||||||240.54|-1055.23|
91786573|NCT01065454|183453139|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-447.26|||||TWO_SIDED|95.0|-1212.74|318.22||||||||318.22|-1212.74|
91786574|NCT01065454|183453139|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-517.48|||||TWO_SIDED|95.0|-1369.48|334.53||||||||334.53|-1369.48|
91786575|NCT01065454|183453140|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||||||||0.01|-0.01|
91786576|NCT01065454|183453140|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.0||||||||0.00|-0.02|
91786577|NCT01065454|183453140|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
91786578|NCT01065454|183453141|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.03||||||||0.03|-0.04|
91786579|NCT01065454|183453141|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.05||||||||0.05|-0.04|
91786580|NCT01065454|183453141|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||||0.03|-0.07|
91786581|NCT01065454|183453142|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANSA Difference|-14.13|||||TWO_SIDED|95.0|-30.79|2.53||||||||2.53|-30.79|
91786582|NCT01065454|183453142|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-12.73|||||TWO_SIDED|95.0|-32.89|7.43||||||||7.43|-32.89|
91786583|NCT01065454|183453142|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-18.27|||||TWO_SIDED|95.0|-41.53|5.0||||||||5.00|-41.53|
91786584|NCT03630770|183453181|OTHER||Rate Ratio|0.98||||0.9|TWO_SIDED|95.0|0.55|1.7||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.||1.7|0.55|0.9
91786585|NCT03630770|183453181|OTHER||Rate Ratio|8.1|||<|0.001|TWO_SIDED|95.0|2.6|25.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.||25|2.6|<0.001
91786586|NCT03630770|183453181|OTHER||Rate Ratio|0.15||||0.02|TWO_SIDED|95.0|0.03|0.75||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.||0.75|0.03|0.02
91786587|NCT03630770|183453181|OTHER||Rate Ratio|61.0|||<|0.001|TWO_SIDED|95.0|6.9|533.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.||533|6.9|<0.001
91786588|NCT02558829|183453182|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= MAC outcome positive and ITT outcome positive; C = MAC outcome negative and ITT positive|CI (Clopper Pearson): positive agreement|74.32|||||TWO_SIDED|95.0|62.84|83.78||||||The estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The performance of the MAC (cut-off point 2.8 ng/mL) was considered to be acceptable if the lower bound of the two-sided 95% CI (or lower bound of the one-sided 97.5% CI) was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.||83.78|62.84|
91786589|NCT02558829|183453182|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = MAC outcome negative and ITT outcome negative; B = MAC outcome positive and ITT outcome negative|CI (Clopper Pearson): negative agreement|93.94|||||TWO_SIDED|95.0|85.2|98.32||||||Please refer to Statistical Analysis 1.||98.32|85.20|
91786590|NCT02558829|183453183|OTHER|The secondary diagnostic accuracy measure was 'percent overall agreement'.|overall agreement|83.57|||||TWO_SIDED|95.0|76.38|89.29||||||This variable was analyzed using the same methodology described for the analyses for the primary efficacy variables. in the below, the results for Step 1 (peak GH level among all post baseline samples) are presented.||89.29|76.38|
91786591|NCT02558829|183453185|OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|6.38|||TWO_SIDED|||||||||"Pre/post dose comparison of ECGs was done for both GHSTs. During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.~Calculations were done from two time points: baseline and 60 min post-dose. Baseline is either the screening or pre-dose value."||||
91786592|NCT02558829|183453185|OTHER|Please refer to Statistical Analysis 1 for this secondary outcome measure.|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|8.15|||TWO_SIDED|||||||||||||
91786593|NCT02558829|183453186|OTHER|Sensitivity is the probability that the test result is positive given the subject has the disease (for the purpose of this analysis, all group A subjects were assumed to have AGHD, but none of the group D subjects). Sensitivity (SS) was estimated by: SS = TP/(TP+FN). TP=True AGHD positive subject; FN=False AGHD negative subject.|CI (Clopper Pearson)|0.87|||||TWO_SIDED|95.0|0.72|0.96||||||Sensitivity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||0.96|0.72|
91786594|NCT02558829|183453186|OTHER|"Specificity is the probability that the test result is negative given the subject does not have the disease.~Specificity (SP) was estimated by: SP = TN/(TN+FP). TN = True AGHD negative Subjects; FP = False AGHD positive subjects."|CI (Clopper Pearson)|0.96|||||TWO_SIDED|95.0|0.8|1.0||||||Specificity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||1.00|0.80|
91786595|NCT02558829|183453187|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= test outcome positive for MAC core study part and positive for MAC repeatability extension; C = test outcome positive for MAC core study part and negative for MAC repeatability extension.|CI (Clopper Pearson): positive agreement|88.89|||||TWO_SIDED|95.0|65.29|98.62||||||Please refer to Statistical Analysis 1 for this outcome.||98.62|65.29|
91786596|NCT02558829|183453187|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = test outcome negative for MAC core study part and negative for MAC repeatability extension; B = test outcome negative for MAC core study part and positive for MAC repeatability extension|CI (Clopper Pearson): negative agreement|100.0|||||TWO_SIDED|95.0|79.41|100.0||||||Amendment no 1 had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study.||100.00|79.41|
91786597|NCT00955201|183453216|SUPERIORITY|||||||0.49||||||Tukey's multiple comparisons test|ANOVA|Comparison to baseline values||Evaluated within group across time||||0.49
91786598|NCT00955201|183453216|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.82
91786599|NCT00955201|183453216|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.96
91786600|NCT00955201|183453216|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.93
91786601|NCT00955201|183453216|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
91786602|NCT00955201|183453216|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wk||||0.31
91786603|NCT00955201|183453216|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 24-wk||||0.28
91786604|NCT00955201|183453217|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.53
91786605|NCT00955201|183453217|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
91786606|NCT00955201|183453217|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
91786607|NCT00955201|183453217|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
91786608|NCT00955201|183453217|SUPERIORITY|||||||0.8|||||||ANOVA|||Comparison across groups at baseline.||||0.80
91786609|NCT00955201|183453217|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 12-wks||||0.63
91786610|NCT00955201|183453217|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 24-wk||||0.31
91786611|NCT00955201|183453218|SUPERIORITY|||||||0.39||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.39
91786612|NCT00955201|183453218|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
91786613|NCT00955201|183453218|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
91786614|NCT00955201|183453218|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
91786615|NCT00955201|183453218|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline||||0.70
91786616|NCT00955201|183453218|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at 12-wks||||0.45
91786617|NCT00955201|183453218|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24-wks||||0.22
91786618|NCT00955201|183453219|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
91786619|NCT00955201|183453219|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.90
91786620|NCT00955201|183453219|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
91522964|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.576||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.576
91522965|NCT02173054|182921364|SUPERIORITY_OR_OTHER|||||||0.16||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.160
91522966|NCT02173054|182921365|SUPERIORITY_OR_OTHER|||||||0.078||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.078
91522967|NCT02173054|182921365|SUPERIORITY_OR_OTHER|||||||0.167||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.167
91522968|NCT02173054|182921365|SUPERIORITY_OR_OTHER|||||||0.134||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group|Paired t-test|||||||0.134
91522969|NCT02173054|182921365|SUPERIORITY_OR_OTHER|||||||0.978||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.978
91602502|NCT04426695|183097546|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
91522970|NCT02173054|182921365|SUPERIORITY_OR_OTHER|||||||0.273||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.273
91522971|NCT02173054|182921365|SUPERIORITY_OR_OTHER|||||||0.735||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.735
91522972|NCT02173054|182921366|SUPERIORITY_OR_OTHER|||||||0.0002||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.|Paired t-test|||||||0.0002
91522973|NCT02173054|182921366|SUPERIORITY_OR_OTHER|||||||0.007||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.|Paired t-test|||||||0.007
91522974|NCT02173054|182921366|SUPERIORITY_OR_OTHER|||||||0.123||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.123
91522975|NCT02173054|182921367|SUPERIORITY_OR_OTHER|||||||0.005||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.005
91522976|NCT02173054|182921367|SUPERIORITY_OR_OTHER|||||||0.606||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.606
91522977|NCT02173054|182921367|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
91602503|NCT04426695|183097546|SUPERIORITY|||||||0.988||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9880
91522978|NCT01932697|182921373|SUPERIORITY|||||||0.01|||||||Paired t-test|||||||.01
91522979|NCT01932697|182921374|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
91522980|NCT01932697|182921375|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
91522981|NCT01932697|182921376|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
91522982|NCT00215540|182921395|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.476
91522983|NCT00215540|182921395|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.208
91522984|NCT00215540|182921396|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.500
91786621|NCT00955201|183453219|SUPERIORITY|||||||0.78||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.78
91522985|NCT00215540|182921396|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.146
91522986|NCT00215540|182921397|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
91522987|NCT00215540|182921397|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
91522988|NCT00215540|182921397|SUPERIORITY_OR_OTHER|||||||0.944||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.944
91522989|NCT00215540|182921398|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.476
91786622|NCT00955201|183453219|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
91786623|NCT00955201|183453219|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 12-wk||||0.97
91786624|NCT00955201|183453219|SUPERIORITY|||||||0.99|||||||ANOVA|||Comparison across groups at 24-wks||||0.99
91786625|NCT00955201|183453220|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
91786626|NCT00955201|183453220|SUPERIORITY|||||||0.69||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.69
91786627|NCT00955201|183453220|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
91786628|NCT00955201|183453220|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
91786629|NCT00955201|183453220|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline||||0.45
91786630|NCT00955201|183453220|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 12-wks||||0.91
91786631|NCT00955201|183453220|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 24-wks||||0.51
91786632|NCT00955201|183453221|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
91786633|NCT00955201|183453221|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.72
91786634|NCT00955201|183453221|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
91786635|NCT00955201|183453221|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
91786636|NCT00955201|183453221|SUPERIORITY|||||||0.85|||||||ANOVA|||Comparison across groups at baseline||||0.85
91786637|NCT00955201|183453221|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at 12-wks||||0.98
91786638|NCT00955201|183453221|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24-wks||||0.68
91786639|NCT00955201|183453222|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.91
91786640|NCT00955201|183453222|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
91786641|NCT00955201|183453222|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
91786642|NCT00955201|183453222|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
91786643|NCT00955201|183453222|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline||||0.38
91786644|NCT00955201|183453222|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
91786645|NCT00955201|183453222|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 24-wks||||0.94
91786646|NCT00955201|183453223|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
91786647|NCT00955201|183453223|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.97
91786648|NCT00955201|183453223|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
91786649|NCT00955201|183453223|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
91786650|NCT00955201|183453223|SUPERIORITY|||||||0.16|||||||ANOVA|||Comparison across groups at baseline.||||0.16
91786651|NCT00955201|183453223|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 12-wks||||0.37
91786652|NCT00955201|183453223|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at 24-wks||||0.75
91786653|NCT00955201|183453224|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
91786654|NCT00955201|183453224|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
91786655|NCT00955201|183453224|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
91786656|NCT00955201|183453224|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
91786657|NCT00955201|183453224|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at baseline||||0.28
91786658|NCT00955201|183453224|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 12-wks||||0.28
91786659|NCT00955201|183453224|SUPERIORITY|||||||0.83|||||||ANOVA|||Comparison across groups at 24-wks||||0.83
91786660|NCT00955201|183453225|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
91786661|NCT00955201|183453225|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
91786662|NCT00955201|183453225|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.82
91786663|NCT00955201|183453225|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.96
91786664|NCT00955201|183453225|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at baseline.||||0.55
91786665|NCT00955201|183453225|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wks||||0.31
91786666|NCT00955201|183453225|SUPERIORITY|||||||0.32|||||||ANOVA|||Comparison across groups at 24-wks||||0.32
91650423|NCT02661126|183193521|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.96|||||TWO_SIDED|90.0|1.54|2.48||||||||2.48|1.54|
91786667|NCT00955201|183453226|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
91786668|NCT00955201|183453226|SUPERIORITY|||||||0.92||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.92
91786669|NCT00955201|183453226|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.93
91786670|NCT00955201|183453226|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
91786671|NCT00955201|183453226|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at baseline.||||0.50
91786672|NCT00955201|183453226|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12-wks.||||0.47
91786673|NCT00955201|183453226|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 24-wks||||0.97
91786674|NCT00955201|183453227|SUPERIORITY|||||||0.83||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.83
91786675|NCT00955201|183453227|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.91
91522990|NCT00215540|182921398|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.208
91522991|NCT00215540|182921398|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.046
91522992|NCT00215540|182921399|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.285
91522993|NCT00215540|182921399|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.229
91522994|NCT00215540|182921399|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.030
91522995|NCT00215540|182921400|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.483
91522996|NCT00215540|182921400|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.123
91522997|NCT00215540|182921400|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.006
91650424|NCT02661126|183193522|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.7|||||TWO_SIDED|90.0|1.29|2.24||||||||2.24|1.29|
91786676|NCT00955201|183453227|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
91786677|NCT00955201|183453227|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.95
91786678|NCT00955201|183453227|SUPERIORITY|||||||0.26|||||||ANOVA|||Comparison across groups at baseline.||||0.26
91786679|NCT00955201|183453227|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at 12-wks||||0.42
91786680|NCT00955201|183453227|SUPERIORITY|||||||0.95|||||||ANOVA|||Comparison across groups at 24-wks.||||0.95
91786681|NCT00955201|183453228|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
91786682|NCT00955201|183453228|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.53
91786683|NCT00955201|183453228|SUPERIORITY|||||||0.79||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.79
91602504|NCT04426695|183097546|SUPERIORITY|||||||0.2498||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2498
91786684|NCT00955201|183453228|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.94
91786685|NCT00955201|183453228|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at baseline||||0.75
91786686|NCT00955201|183453228|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
91786687|NCT00955201|183453228|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 24-wks.||||0.63
91786688|NCT00955201|183453229|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.98
91786689|NCT00955201|183453229|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
91786690|NCT00955201|183453229|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.89
91786691|NCT00955201|183453229|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.90
91786692|NCT00955201|183453229|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at baseline||||0.98
91786693|NCT00955201|183453229|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 12-wks||||0.94
91786694|NCT00955201|183453229|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 24-wks.||||0.91
91786695|NCT00955201|183453230|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
91786696|NCT00955201|183453230|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
91786697|NCT00955201|183453230|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
91786698|NCT00955201|183453230|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786699|NCT00955201|183453230|SUPERIORITY|||||||0.96|||||||ANOVA|||Comparison across groups at baseline.||||0.96
91786700|NCT00955201|183453230|SUPERIORITY|||||||0.86|||||||ANOVA|||Comparison across groups at 12-wks.||||0.86
91786701|NCT00955201|183453230|SUPERIORITY|||||||0.92|||||||ANOVA|||Comparison across groups at 24-wks.||||0.92
91786702|NCT00955201|183453231|SUPERIORITY|||||||0.03||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.03
91786703|NCT00955201|183453231|SUPERIORITY|||||||0.29||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.29
91786704|NCT00955201|183453231|SUPERIORITY|||||||0.36||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.36
91786705|NCT00955201|183453231|SUPERIORITY|||||||0.15||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.15
91786706|NCT00955201|183453231|SUPERIORITY|||||||0.2||||||ANOVA|ANOVA|||Comparison of pre- and post-responses across groups at baseline.||||0.20
91786707|NCT00955201|183453231|SUPERIORITY|||||||0.51||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 12 wks.||||0.51
91786708|NCT00955201|183453231|SUPERIORITY|||||||0.59||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 24 wks.||||0.59
91786709|NCT00955201|183453232|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
91786710|NCT00955201|183453232|SUPERIORITY|||||||0.01||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.01
91786711|NCT00955201|183453232|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
91786712|NCT00955201|183453232|SUPERIORITY|||||||0.98||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.98
91786713|NCT00955201|183453232|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.96
91786714|NCT00955201|183453232|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.06
91786715|NCT00955201|183453232|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.14
91786716|NCT00955201|183453233|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786717|NCT00955201|183453233|SUPERIORITY|||||||0.36||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.36
91786718|NCT00955201|183453233|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
91786719|NCT00955201|183453233|SUPERIORITY|||||||0.46||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.46
91786720|NCT00955201|183453233|SUPERIORITY|||||||0.14|||||||ANOVA|||Comparison across groups at baseline.||||0.14
91786721|NCT00955201|183453233|SUPERIORITY|||||||0.05|||||||ANOVA|||Comparison across groups at 12 wks.||||0.05
91786722|NCT00955201|183453233|SUPERIORITY|||||||0.01|||||||ANOVA|||Comparison across groups at 24 wks.||||0.01
91786723|NCT00955201|183453234|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
91786724|NCT00955201|183453234|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
91786725|NCT00955201|183453234|SUPERIORITY|||||||0.67||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.67
91786726|NCT00955201|183453234|SUPERIORITY|||||||0.55||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.55
91786727|NCT00955201|183453234|SUPERIORITY|||||||0.4||||||Tukey's multiple comparisons test:|ANOVA|||Comparison across groups at baseline.||||0.40
91786728|NCT00955201|183453234|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12 wks.||||0.47
91786729|NCT00955201|183453234|SUPERIORITY|||||||0.43|||||||ANOVA|||Comparison across groups at 24 wks.||||0.43
91786730|NCT00955201|183453235|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
91786731|NCT00955201|183453235|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
91786732|NCT00955201|183453235|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
91522998|NCT00215540|182921401|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|Adjusting for pooled study center||||||0.843
91522999|NCT00215540|182921401|SUPERIORITY_OR_OTHER|||||||0.543||95.0|||||ANOVA|Adjusting for pooled study center||||||0.543
91523000|NCT00215540|182921401|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||ANOVA|Adjusting for pooled study center||||||0.537
91523001|NCT00215540|182921402|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||ANOVA|Adjusting for pooled study center||||||0.813
91602505|NCT04426695|183097546|SUPERIORITY|||||||1||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||1.0000
91650425|NCT02661126|183193523|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.47|2.57||||||||2.57|1.47|
91523002|NCT00215540|182921402|SUPERIORITY_OR_OTHER|||||||0.449||95.0|||||ANOVA|Adjusting for pooled study center||||||0.449
91523003|NCT00215540|182921402|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||ANOVA|Adjusting for pooled study center||||||0.275
91523004|NCT00215540|182921403|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
91523005|NCT00215540|182921403|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
91523006|NCT00215540|182921404|SUPERIORITY_OR_OTHER|||||||0.311||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.311
91523007|NCT00215540|182921404|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.516
91523008|NCT00215540|182921404|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.094
91602506|NCT04426695|183097546|SUPERIORITY|||||||0.0457||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0457
91786733|NCT00955201|183453235|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
91602507|NCT04426695|183097546|SUPERIORITY|||||||0.2153||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2153
91602508|NCT04426695|183097547|SUPERIORITY|||||||0.0811||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0811
91602509|NCT04426695|183097547|SUPERIORITY|||||||0.6701||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.6701
91786734|NCT00955201|183453235|SUPERIORITY|||||||0.88|||||||ANOVA|||Comparison across groups at baseline.||||0.88
91786735|NCT00955201|183453235|SUPERIORITY|||||||0.48|||||||ANOVA|||Comparison across groups at 12 wks.||||0.48
91786736|NCT00955201|183453235|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
91786737|NCT00955201|183453236|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
91786738|NCT00955201|183453236|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
91786739|NCT00955201|183453236|SUPERIORITY|||||||0.51||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.51
91786740|NCT00955201|183453236|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.89
91786741|NCT00955201|183453236|SUPERIORITY|||||||0.46|||||||ANOVA|||Comparison across groups at baseline.||||0.46
91786742|NCT00955201|183453236|SUPERIORITY|||||||0.72|||||||ANOVA|||Comparison across groups at 12 wks.||||0.72
91786743|NCT00955201|183453236|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24wks.||||0.22
91786744|NCT00955201|183453237|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
91786745|NCT00955201|183453237|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
91786746|NCT00955201|183453237|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
91786747|NCT00955201|183453237|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
91786748|NCT00955201|183453237|SUPERIORITY|||||||0.39|||||||ANOVA|||Comparison across groups at baseline.||||0.39
91786749|NCT00955201|183453237|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at 12-wks.||||0.59
91786750|NCT00955201|183453237|SUPERIORITY|||||||0.29|||||||ANOVA|||Comparison across groups at 24-wks.||||0.29
91786751|NCT00955201|183453238|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time||||0.97
91786752|NCT00955201|183453238|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786753|NCT00955201|183453238|SUPERIORITY|||||||0.09||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.09
91786754|NCT00955201|183453238|SUPERIORITY|||||||0.05||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.05
91786755|NCT00955201|183453238|SUPERIORITY|||||||0.11|||||||ANOVA|||Comparison across groups at baseline.||||0.11
91786756|NCT00955201|183453238|SUPERIORITY|||||||0.41|||||||ANOVA|||Comparison across groups at 12-wks.||||0.41
91786757|NCT00955201|183453238|SUPERIORITY|||||||0.03|||||||ANOVA|||Comparison across groups at 24-wks.||||0.03
91786758|NCT00955201|183453239|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
91786759|NCT00955201|183453239|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786760|NCT00955201|183453239|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
91786761|NCT00955201|183453239|SUPERIORITY|||||||0.48||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.48
91786762|NCT00955201|183453239|SUPERIORITY|||||||0.58|||||||ANOVA|||Comparison across groups at baseline.||||0.58
91786763|NCT00955201|183453239|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at 12-wks.||||0.50
91786764|NCT00955201|183453239|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 24-wks.||||0.33
91786765|NCT00955201|183453240|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
91786766|NCT00955201|183453240|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786767|NCT00955201|183453240|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
91786768|NCT00955201|183453240|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
91786769|NCT00955201|183453240|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline.||||0.38
91786770|NCT00955201|183453240|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at 12-wks.||||0.55
91786771|NCT00955201|183453240|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 24-wks||||0.37
91786772|NCT00955201|183453241|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
91786773|NCT00955201|183453241|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
91786774|NCT00955201|183453241|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
91523009|NCT00246337|182921406|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%||||0.015
91602510|NCT04426695|183097547|SUPERIORITY|||||||0.2006||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2006
91602511|NCT04426695|183097547|SUPERIORITY|||||||0.3313||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3313
91786775|NCT00955201|183453241|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time.||||1.00
91786776|NCT00955201|183453241|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.81
91786777|NCT00955201|183453241|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.60
91786778|NCT00955201|183453241|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.99
91786779|NCT00955201|183453242|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
91786780|NCT00955201|183453243|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
91786781|NCT00955201|183453243|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786782|NCT00955201|183453243|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786783|NCT00955201|183453243|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.72
91786784|NCT00955201|183453243|SUPERIORITY|||||||0.62|||||||ANOVA|||Comparison across groups at baseline.||||0.62
91786785|NCT00955201|183453243|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 12 wks.||||0.33
91786786|NCT00955201|183453243|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
91786787|NCT00955201|183453244|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
91786788|NCT00955201|183453244|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786789|NCT00955201|183453244|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
91786790|NCT00955201|183453244|SUPERIORITY|||||||0.76||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.76
91786791|NCT00955201|183453244|SUPERIORITY|||||||0.82|||||||ANOVA|||Comparison across groups at baseline.||||0.82
91786792|NCT00955201|183453244|SUPERIORITY|||||||0.53|||||||ANOVA|||Comparison across groups at 12 wks.||||0.53
91786793|NCT00955201|183453244|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24 wks.||||0.68
91786794|NCT00955201|183453245|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline.||||0.70
91786795|NCT00955201|183453247|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
91786796|NCT00955201|183453248|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline.||||0.45
91786797|NCT00955201|183453249|SUPERIORITY|||||||0.04|||||||ANOVA|||Comparison across groups at baseline.||||0.04
91786798|NCT00955201|183453250|SUPERIORITY|||||||0.77|||||||ANOVA|||Comparison across groups at baseline.||||0.77
91786799|NCT00955201|183453251|SUPERIORITY|||||||0.12|||||||ANOVA|||Comparison across groups at baseline.||||0.12
91786800|NCT00955201|183453252|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at baseline.||||0.42
91786801|NCT00955201|183453253|SUPERIORITY|||||||0.79|||||||ANOVA|||Comparison across groups at baseline.||||0.79
91786802|NCT02737891|183453254|SUPERIORITY||Mean Difference (Net)|-3.8||||0.004|TWO_SIDED|95.0|-6.36|-1.29||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-1.29|-6.36|0.004
91786803|NCT02737891|183453255|SUPERIORITY||Mean Difference (Net)|0.1||||0.724|TWO_SIDED|95.0|-0.23|0.33||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||0.33|-0.23|0.724
91786804|NCT02737891|183453256|SUPERIORITY||Mean Difference (Net)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.65|-2.3||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-2.30|-4.65|<0.0001
91786805|NCT01816945|183453303|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
91786806|NCT01816945|183453306|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Two-sample t-test for PHQ-9 at 12 months||||0.96
91786807|NCT01816945|183453307|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Two-sample t-test for Social Network Score at 12 month||||0.043
91786808|NCT00244140|183453308|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR1|95.8||||||95.0|93.3|97.6||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||97.6|93.3|
91786809|NCT00244140|183453308|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR2|96.3||||||95.0|93.9|98.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||98.0|93.9|
91786810|NCT00244140|183453308|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR3|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||99.4|96.6|
91786811|NCT00244140|183453309|SUPERIORITY_OR_OTHER||Percent Images Rated Yes|99.7||||||95.0|98.6|100.0||||||||100.0|98.6|
91786812|NCT00244140|183453310|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent|99.5||||||95.0|98.1|99.9||||||||99.9|98.1|
91786813|NCT00244140|183453311|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR1|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||99.4|96.6|
91786814|NCT00244140|183453311|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR2|100.0||||||95.0|99.0|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||100.0|99.0|
91786815|NCT00244140|183453311|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR3|99.7||||||95.0|98.6|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||100.0|98.6|
91786816|NCT00275340|183453325|NON_INFERIORITY_OR_EQUIVALENCE|Study was not powered to determine significant group differences; thus trends are reported for p\<0.20.|||||p<|0||95.0|||||t-test, 2 sided|||Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.||||p<0.20
91786817|NCT00862641|183453331|SUPERIORITY_OR_OTHER|||||||0.1451||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with \<15 subjects were pooled.||||||0.1451
91786818|NCT00862641|183453331|SUPERIORITY_OR_OTHER|||||||0.579||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the CMH test stratified by investigative site. Sites with less than 15 subjects were pooled.||||||0.5790
91786819|NCT00862641|183453334|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0029
91786820|NCT00862641|183453334|SUPERIORITY_OR_OTHER|||||||0.6189||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.6189
91786821|NCT00862641|183453335|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0015
91786822|NCT00862641|183453335|SUPERIORITY_OR_OTHER|||||||0.4385||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.4385
91786823|NCT00862641|183453336|SUPERIORITY_OR_OTHER|||||||0.0789||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0789
91786824|NCT00862641|183453336|SUPERIORITY_OR_OTHER|||||||0.0258||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0258
91786825|NCT00862641|183453337|SUPERIORITY_OR_OTHER|||||||0.2087||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.2087
91786826|NCT00862641|183453337|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0289
91786827|NCT00862641|183453338|SUPERIORITY_OR_OTHER|||||||0.9904||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.9904
91786828|NCT00862641|183453338|SUPERIORITY_OR_OTHER|||||||0.8085||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.8085
91786829|NCT02365480|183453342|OTHER||Odds Ratio (OR)|1.91||||0.6|TWO_SIDED|95.0|0.1|36.37|||Fisher Exact|||||36.37|0.10|0.60
91786830|NCT01419197|183453350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528|||<|0.0001|TWO_SIDED|95.0|0.422|0.661||The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.661|0.422|<0.0001
91786831|NCT01419197|183453351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.552||||0.0034|TWO_SIDED|95.0|0.369|0.826||The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.826|0.369|0.0034
91786832|NCT01419197|183453352|SUPERIORITY_OR_OTHER||Difference in Response Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|16.2|29.2|||Mantel Haenszel|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||29.2|16.2|<0.0001
91786833|NCT01419197|183453354|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.6||||0.0011|TWO_SIDED|95.0|5.03|20.09||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||20.09|5.03|0.0011
91786834|NCT01419197|183453354|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.7||||0.1805|TWO_SIDED|95.0|-5.41|28.75||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||28.75|-5.41|0.1805
91786835|NCT01419197|183453355|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.115||||0.4952|TWO_SIDED|95.0|0.819|1.517|||Log Rank|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||1.517|0.819|0.4952
91602512|NCT04426695|183097547|SUPERIORITY|||||||0.5542||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5542
91602513|NCT04426695|183097547|SUPERIORITY|||||||0.2214||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2214
91602514|NCT04426695|183097548|SUPERIORITY|||||||0.0389||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0389
91602515|NCT04426695|183097548|SUPERIORITY|||||||0.5208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5208
91602516|NCT04426695|183097548|SUPERIORITY|||||||0.1079||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1079
91786836|NCT01419197|183453357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0007|TWO_SIDED|95.0|0.539|0.85||The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).||0.850|0.539|0.0007
91602517|NCT04426695|183097548|SUPERIORITY|||||||0.3315||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3315
91602518|NCT04426695|183097548|SUPERIORITY|||||||0.5797||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5797
91786837|NCT01419197|183453358|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.4||||0.0003|TWO_SIDED|95.0|5.67|19.14||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||19.14|5.67|0.0003
91786838|NCT01419197|183453358|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.0||||0.0104|TWO_SIDED|95.0|2.58|19.33||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||19.33|2.58|0.0104
91602519|NCT04426695|183097548|SUPERIORITY|||||||0.3036||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3036
91602520|NCT04426695|183097549|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
91602521|NCT04426695|183097549|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
91602522|NCT04426695|183097549|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
91602523|NCT04426695|183097549|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
91786839|NCT01099449|183453361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.73
91786840|NCT01099449|183453361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.29
91786841|NCT01099449|183453362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.054|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.054
91602524|NCT04426695|183097549|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
91602525|NCT04426695|183097549|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
91786842|NCT01099449|183453362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.27|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.27
91790556|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790557|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.707|TWO_SIDED|95.0|-0.256|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.378|-0.256|0.707
91602526|NCT04426695|183097550|SUPERIORITY|||||||0.2635||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2635
91602527|NCT04426695|183097550|SUPERIORITY|||||||0.8013||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8013
91602528|NCT04426695|183097550|SUPERIORITY|||||||0.416||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4160
91790558|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91786843|NCT01099449|183453363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.29
91786844|NCT01099449|183453363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.25|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.25
91786845|NCT01099449|183453366|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.89|||||||Kruskal-Wallis|||||||.89
91786846|NCT01099449|183453366|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.496|||||||Kruskal-Wallis|||||||.496
91786847|NCT01099449|183453367|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.52|||||||Chi-squared|||||||.52
91786848|NCT01099449|183453367|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.66|||||||Chi-squared|||||||.66
91786849|NCT00146848|183453371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.75||0.86|TWO_SIDED|95.0|-3.14|3.74|||t-test, 2 sided|||The changes in quality of life were compared between groups using two-sided t-tests.||3.74|-3.14|0.86
91786850|NCT00146848|183453371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.87||0.43|TWO_SIDED|95.0|-2.18|5.16|||t-test, 2 sided|||The difference in changes in quality of life between groups were compared using a t-test.||5.16|-2.18|0.43
91786851|NCT00146848|183453372|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Armitage test for trend|||One sided test testing for shift towards improvement in either atrial support pacing treatment arm compared to the DDD-40 arm.||||0.55
91786852|NCT00146848|183453372|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Armitage test for trend|||||||0.80
91786853|NCT00146848|183453373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.17|STANDARD_ERROR_OF_MEAN|6.35||0.11|TWO_SIDED|95.0|-22.65|2.3|||t-test, 2 sided|||Compare the difference in the changes in physical activity scores between groups using a t-test.||2.30|-22.65|0.11
91786854|NCT00146848|183453373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|STANDARD_ERROR_OF_MEAN|6.55||0.04|TWO_SIDED|95.0|-26.11|-0.37|||t-test, 2 sided|||"Compare the difference in the changes in physical activity scores between groups using a t-test.~To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance."||-0.37|-26.11|0.04
91786855|NCT01798849|183453376|OTHER||Difference in Least-square (LS) Means|-0.5||||0.732|TWO_SIDED|95.0|-3.42|2.43|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.43|-3.42|0.732
91786856|NCT01798849|183453376|OTHER||Difference in LS means|-0.94||||0.531|TWO_SIDED|95.0|-3.94|2.06|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.06|-3.94|0.531
91786857|NCT01798849|183453376|OTHER||Difference in LS Means|-2.88||||0.056|TWO_SIDED|95.0|-5.83|0.08|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.08|-5.83|0.056
91786858|NCT01798849|183453376|OTHER||Difference in LS means|-2.92||||0.063|TWO_SIDED|95.0|-6.0|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-6.00|0.063
91650426|NCT02661126|183193526|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.33|||||TWO_SIDED|90.0|0.65|2.75||||||||2.75|0.65|
91786859|NCT01798849|183453376|OTHER||Difference in LS means|-4.89||||0.002|TWO_SIDED|95.0|-7.79|-1.99|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.99|-7.79|0.002
91786860|NCT01798849|183453376|OTHER||Difference in LS means|-5.31||||0.001|TWO_SIDED|95.0|-8.32|-2.31|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.31|-8.32|0.001
91602529|NCT04426695|183097550|SUPERIORITY|||||||0.2194||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2194
91650427|NCT02661126|183193527|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.59|||||TWO_SIDED|90.0|0.79|3.19||||||||3.19|0.79|
91786861|NCT01798849|183453376|OTHER||Difference in LS means|-5.61||||0.001|TWO_SIDED|95.0|-8.62|-2.6|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.60|-8.62|0.001
91786862|NCT01798849|183453376|OTHER||Difference in LS means|-7.56|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.63|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.63|-10.50|<0.0001
91786863|NCT01798849|183453379|OTHER||Difference in LS means|-2.34||||0.165|TWO_SIDED|95.0|-5.7|1.02|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.02|-5.70|0.165
91786864|NCT01798849|183453379|OTHER||Difference in LS means|-3.53||||0.038|TWO_SIDED|95.0|-6.86|-0.21|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.21|-6.86|0.038
91786865|NCT01798849|183453379|OTHER||Difference in LS means|-6.32||||0|TWO_SIDED|95.0|-9.55|-3.1|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.10|-9.55|0.000
91786866|NCT01798849|183453379|OTHER||Difference in LS means|-6.63|||<|0.0001|TWO_SIDED|95.0|-9.35|-3.92|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.92|-9.35|<0.0001
91786867|NCT01798849|183453380|OTHER||Difference in LS means|-2.67||||0.128|TWO_SIDED|95.0|-6.14|0.8|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.80|-6.14|0.128
91786868|NCT01798849|183453380|OTHER||Difference in LS means|-0.76||||0.305|TWO_SIDED|95.0|-2.24|0.72|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.72|-2.24|0.305
91786869|NCT01798849|183453380|OTHER||Difference in LS means|-2.03||||0.07|TWO_SIDED|95.0|-4.23|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-4.23|0.070
91786870|NCT01798849|183453380|OTHER||Difference in LS means|-2.84||||0.036|TWO_SIDED|95.0|-5.48|-0.19|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.19|-5.48|0.036
91786871|NCT01798849|183453380|OTHER||Difference in LS means|-4.89|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.37|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.37|-6.40|<0.0001
91786872|NCT01798849|183453380|OTHER||Difference in LS means|-5.37|||<|0.0001|TWO_SIDED|95.0|-7.29|-3.46|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.46|-7.29|<0.0001
91786873|NCT01798849|183453380|OTHER||Difference in LS means|-5.68|||<|0.0001|TWO_SIDED|95.0|-6.7|-4.65|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.65|-6.70|<0.0001
91786874|NCT01798849|183453380|OTHER||Difference in LS means|-8.22|||<|0.0001|TWO_SIDED|95.0|-11.95|-4.5|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.50|-11.95|<0.0001
91786875|NCT01798849|183453381|OTHER||Difference in LS means|-1.77||||0.212|TWO_SIDED|95.0|-4.59|1.05|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.05|-4.59|0.212
91786876|NCT01798849|183453381|OTHER||Difference in LS means|3.32||||0.05|TWO_SIDED|95.0|0.0|6.64|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||6.64|0.00|0.050
91602530|NCT04426695|183097550|SUPERIORITY|||||||0.324||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3240
91650428|NCT02661126|183193528|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.15|||||TWO_SIDED|90.0|0.51|2.57||||||||2.57|0.51|
91650429|NCT02661126|183193529|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.23|||||TWO_SIDED|90.0|0.5|3.05||||||||3.05|0.50|
91650430|NCT02661126|183193530|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.28|||||TWO_SIDED|90.0|0.56|2.91||||||||2.91|0.56|
91602531|NCT04426695|183097550|SUPERIORITY|||||||0.1981||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1981
91602532|NCT02769728|183097571|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||The threshold for statistical significance was p = 0.05||||0.001
91602533|NCT02769728|183097572|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.081
91602534|NCT02769728|183097573|SUPERIORITY|||||||0.114||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.114
91602535|NCT02769728|183097574|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.021
91602536|NCT02769728|183097575|SUPERIORITY|||||||1||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||1.00
91602537|NCT00849667|183097577|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4513|TWO_SIDED|95.0|0.81|1.21|||Log Rank|One-sided log rank test||||1.21|0.81|0.4513
91602538|NCT00849667|183097577|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0761|TWO_SIDED|95.0|0.7|1.06|||Log Rank|One-sided log rank test||||1.06|0.70|0.0761
91602539|NCT00849667|183097578|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4823|TWO_SIDED|95.0|0.78|1.27|||Log Rank|One-sided log rank test||||1.27|0.78|0.4823
91786877|NCT01798849|183453381|OTHER||Difference in LS means|2.48||||0.016|TWO_SIDED|95.0|0.49|4.47|||Mixed effect model||Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.47|0.49|0.016
91786878|NCT01798849|183453381|OTHER||Difference in LS means|5.21||||0.007|TWO_SIDED|95.0|1.51|8.92|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||8.92|1.51|0.007
91602540|NCT00849667|183097578|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1616|TWO_SIDED|95.0|0.68|1.13|||Log Rank|One-sided log rank test||||1.13|0.68|0.1616
91602541|NCT00849667|183097579|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2938|TWO_SIDED|95.0|0.72|1.21|||Log Rank|One-sided log-rank test||||1.21|0.72|0.2938
91602542|NCT00849667|183097579|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0318|TWO_SIDED|95.0|0.58|1.02|||Log Rank|One-sided log-rank test||||1.02|0.58|0.0318
91602543|NCT00849667|183097580|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5636|TWO_SIDED|95.0|0.85|1.21|||Log Rank|One-sided log-rank test||||1.21|0.85|0.5636
91602544|NCT00849667|183097580|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.156|TWO_SIDED|95.0|0.76|1.09|||Log Rank|One-sided log-rank test||||1.09|0.76|0.1560
91602545|NCT00849667|183097582|SUPERIORITY||Difference in percentage|1.8||||0.6864|TWO_SIDED|95.0|-5.4|9.0|||Cochran-Mantel-Haenszel|||||9.0|-5.4|0.6864
91602546|NCT00849667|183097582|SUPERIORITY||Difference in percentage|2.4||||0.4923|TWO_SIDED|95.0|-4.8|9.6|||Cochran-Mantel-Haenszel|||||9.6|-4.8|0.4923
91602547|NCT00849667|183097585|SUPERIORITY||Difference in percentage|-0.4||||0.8106|TWO_SIDED|95.0|-4.9|4.1|||Cochran-Mantel-Haenszel|||50% serological response||4.1|-4.9|0.8106
91602548|NCT00849667|183097585|SUPERIORITY||Difference in percentage|5.1||||0.0064|TWO_SIDED|95.0|1.4|8.8|||Cochran-Mantel-Haenszel|||50% serological response||8.8|1.4|0.0064
91602549|NCT00849667|183097585|SUPERIORITY||Difference in percentage|4.1||||0.3005|TWO_SIDED|95.0|-2.0|10.2|||Cochran-Mantel-Haenszel|||75% serological response||10.2|-2.0|0.3005
91602550|NCT00849667|183097585|SUPERIORITY||Difference in percentage|3.7||||0.2445|TWO_SIDED|95.0|-2.5|9.9|||Cochran-Mantel-Haenszel|||75% serological response||9.9|-2.5|0.2445
91786879|NCT01798849|183453381|OTHER||Difference in LS means|7.06||||0.001|TWO_SIDED|95.0|3.03|11.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.10|3.03|0.001
91786880|NCT01798849|183453381|OTHER||Difference in LS means|6.62||||0.002|TWO_SIDED|95.0|2.54|10.71|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.71|2.54|0.002
91602551|NCT00849667|183097585|SUPERIORITY||Difference in percentage|5.3||||0.2797|TWO_SIDED|95.0|-2.8|13.4|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.4|-2.8|0.2797
91602552|NCT00849667|183097585|SUPERIORITY||Difference in percentage|4.9||||0.2136|TWO_SIDED|95.0|-3.2|13.0|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.0|-3.2|0.2136
91602553|NCT01262625|183097604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|the pre-defined non-inferiority margin of 1.25|Hazard Ratio (HR)|1.03||||0.19|TWO_SIDED|95.0|0.61|1.75|||Regression, Cox|||||1.75|0.61|0.19
91602554|NCT01262625|183097605|SUPERIORITY|||||||0.08|||||||DeLong|(DeLong et al 1988)||||||0.08
91602555|NCT01262625|183097605|SUPERIORITY|||||||0.02|||||||DeLong|(DeLong et al 1988)||||||0.02
91602556|NCT00110994|183097608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.068|TWO_SIDED|95.0|0.428|1.034|||log rank test|||||1.034|0.428|0.068
91602557|NCT00110994|183097609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.973|TWO_SIDED|95.0|0.627|1.57|||log rank test|||||1.570|0.627|0.973
91602558|NCT00110994|183097611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.039|TWO_SIDED|95.0|0.391|0.98|||log rank test|||||0.980|0.391|0.039
91602559|NCT00110994|183097612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.427||||0.194|TWO_SIDED|95.0|0.114|1.601|||log rank test|||||1.601|0.114|0.194
91602560|NCT00110994|183097614|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||t-test, 2 sided|||||||0.908
91602561|NCT00110994|183097615|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||t-test, 2 sided|||||||0.890
91786881|NCT01798849|183453381|OTHER||Difference in LS means|8.11|||<|0.0001|TWO_SIDED|95.0|5.45|10.76|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.76|5.45|<0.0001
91602562|NCT00110994|183097616|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||t-test, 2 sided|||||||0.201
91602563|NCT00110994|183097617|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||t-test, 2 sided|||||||0.168
91602564|NCT04398732|183097618|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 12.||||0.0001
91786882|NCT01798849|183453381|OTHER||Difference in LS means|14.05|||<|0.0001|TWO_SIDED|95.0|10.54|17.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||17.57|10.54|<0.0001
91786883|NCT01798849|183453382|OTHER||Difference in LS means|-1.66||||0.202|TWO_SIDED|95.0|-4.24|0.93|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.93|-4.24|0.202
91650431|NCT02661126|183193535|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.56|||||TWO_SIDED|90.0|1.19|2.05||||||||2.05|1.19|
91786884|NCT01798849|183453382|OTHER||Difference in LS means|-2.23||||0.115|TWO_SIDED|95.0|-5.03|0.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.57|-5.03|0.115
91786885|NCT01798849|183453382|OTHER||Difference in LS means|-2.75||||0.043|TWO_SIDED|95.0|-5.4|-0.09|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.09|-5.40|0.043
91602565|NCT04398732|183097619|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 12.||||0.0001
91786886|NCT01798849|183453382|OTHER||Difference in LS means|-0.19||||0.901|TWO_SIDED|95.0|-3.22|2.84|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.84|-3.22|0.901
91786887|NCT01798849|183453382|OTHER||Mixed effect model|-4.15||||0.002|TWO_SIDED|95.0|-6.74|-1.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|||-1.57|-6.74|0.002
91786888|NCT01798849|183453382|OTHER||Difference in LS means|-3.77||||0.008|TWO_SIDED|95.0|-6.48|-1.06|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.06|-6.48|0.008
91786889|NCT01798849|183453382|OTHER||Difference in LS means|-1.77||||0.201|TWO_SIDED|95.0|-4.51|0.98|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.98|-4.51|0.201
91602566|NCT04398732|183097620|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 12.||||0.0001
91602567|NCT04398732|183097621|OTHER|||||||0.036|||||||Student's t-test|||Baseline||||0.036
91602568|NCT04398732|183097621|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
91602569|NCT04398732|183097621|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
91602570|NCT04398732|183097622|OTHER|||||||0.42|||||||Student's t-test|||Baseline||||0.42
91602571|NCT04398732|183097622|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
91602572|NCT04398732|183097622|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
91602573|NCT04398732|183097623|OTHER|||||||0.72|||||||Student's t-test|||Baseline||||0.72
91602574|NCT04398732|183097623|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
91602575|NCT04398732|183097623|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
91602576|NCT04398732|183097624|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 4.||||0.0001
91602577|NCT04398732|183097625|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 4.||||0.0001
91602578|NCT04398732|183097626|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 4.||||0.0001
91650432|NCT02661126|183193536|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.57|||||TWO_SIDED|90.0|1.2|2.05||||||||2.05|1.20|
91650433|NCT02661126|183193537|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.49|||||TWO_SIDED|90.0|1.13|1.98||||||||1.98|1.13|
91650434|NCT02661126|183193538|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.44|||||TWO_SIDED|90.0|1.05|1.98||||||||1.98|1.05|
91786890|NCT01798849|183453382|OTHER||Difference in LS means|-4.74||||0.001|TWO_SIDED|95.0|-7.37|-2.11|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.11|-7.37|0.001
91786891|NCT01798849|183453383|OTHER||Difference in LS means|-2.53||||0.042|TWO_SIDED|95.0|-4.97|-0.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.10|-4.97|0.042
91786892|NCT01798849|183453383|OTHER||Difference in LS means|-3.29||||0.01|TWO_SIDED|95.0|-5.71|-0.88|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.88|-5.71|0.010
91786893|NCT01798849|183453383|OTHER||Difference in LS means|-6.42|||<|0.0001|TWO_SIDED|95.0|-8.94|-3.89|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.89|-8.94|<0.0001
91786894|NCT01798849|183453383|OTHER||Difference in LS means|-8.28|||<|0.0001|TWO_SIDED|95.0|-11.32|-5.25|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-5.25|-11.32|<0.0001
91786895|NCT01798849|183453384|OTHER||Difference in LS means|0.54||||0.638|TWO_SIDED|95.0|-1.8|2.87|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.87|-1.80|0.638
91786896|NCT01798849|183453384|OTHER||Difference in LS means|0.72||||0.616|TWO_SIDED|95.0|-2.2|3.63|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||3.63|-2.20|0.616
91786897|NCT01798849|183453384|OTHER||Difference in LS means|2.33||||0.041|TWO_SIDED|95.0|0.11|4.56|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.56|0.11|0.041
91786898|NCT01798849|183453384|OTHER||Difference in LS means|9.14|||<|0.0001|TWO_SIDED|95.0|6.98|11.3|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.30|6.98|<0.0001
91786899|NCT01798849|183453385|OTHER||Difference in LS means|-0.65||||0.677|TWO_SIDED|95.0|-3.81|2.52|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.52|-3.81|0.677
91786900|NCT01798849|183453385|OTHER||Difference in LS means|-0.92||||0.554|TWO_SIDED|95.0|-4.08|2.24|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.24|-4.08|0.554
91786901|NCT01798849|183453385|OTHER||Difference in LS means|-2.29||||0.137|TWO_SIDED|95.0|-5.35|0.78|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.78|-5.35|0.137
91786902|NCT01798849|183453385|OTHER||Difference in LS means|-3.78||||0.006|TWO_SIDED|95.0|-6.37|-1.19|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.19|-6.37|0.006
91786903|NCT02395172|183453403|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.0721|TWO_SIDED|95.0|0.71|1.05|||Log Rank|||||1.05|0.71|= 0.0721
91786904|NCT02395172|183453404|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||||1.05|0.77|
91786905|NCT02395172|183453405|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
91786906|NCT02395172|183453406|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.98|1.41||||||||1.41|0.98|
91786907|NCT02395172|183453409|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.92|2.13||||||||2.13|0.92|
91786908|NCT02395172|183453410|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.08|2.86||||||||2.86|1.08|
91786909|NCT00612105|183453426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.2537|TWO_SIDED|95.0|-1.171|0.312|||ANCOVA|||||0.312|-1.171|0.2537
91786910|NCT00475982|183453489|SUPERIORITY||Mean Difference (Final Values)|0.965||||0.965|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.965
91786911|NCT00475982|183453490|SUPERIORITY||Mean Difference (Final Values)|0.884||||0.884|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.884
91786912|NCT00475982|183453491|SUPERIORITY|||||||0.294|||||||paired t-test|||intra-analysis within the weight loss arm||||0.294
91786913|NCT00475982|183453491|SUPERIORITY|||||||0.44|||||||paired t-test|||intra-analysis within the control arm||||0.440
91786914|NCT00475982|183453491|SUPERIORITY||Mean Difference (Net)|8.49||||0.186|TWO_SIDED|95.0|-4.31|21.3|||paired t-test|||analysis between the weight loss and control arms||21.3|-4.31|0.186
91602579|NCT00464204|183097633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-331.0|STANDARD_DEVIATION|1033.0||0.0185|TWO_SIDED|95.0|-640.0|-21.0||One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.|t-test, 1 sided||Considered difference: Voluven® minus NaCl 0.9 %|"Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl.~Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl."||-21|-640|0.0185
91602580|NCT02086331|183097648|OTHER||||||||||||||||||Intraclass correlation of repeated measures - 0.96, p=0.08|||
91602581|NCT01838044|183097696|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.287||0.6012|TWO_SIDED|95.0|-0.72|0.42|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between two study arms.||0.42|-0.72|0.6012
91602582|NCT01838044|183097697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|1.02|1.83|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.||1.83|1.02|<0.0001
91602583|NCT01838044|183097698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.361||0.5128|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.||0.95|-0.48|0.5128
91602584|NCT01838044|183097700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7251|TWO_SIDED|95.0|-0.22|0.32|||Mixed Models Analysis|||Statistical analysis at Week 5 based on comparison between treatment groups.||0.32|-0.22|0.7251
91602585|NCT01838044|183097700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1255|TWO_SIDED|95.0|-0.06|0.46|||Mixed Models Analysis|||Statistical analysis at Week 10 based on comparison between treatment groups.||0.46|-0.06|0.1255
91602586|NCT01838044|183097702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.317||0.2856|TWO_SIDED|95.0|-0.97|0.29|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between treatment groups.||0.29|-0.97|0.2856
91602587|NCT01838044|183097702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.363||0.3987|TWO_SIDED|95.0|-1.02|0.41|||Mixed Models Analysis|||Statistical analysis at Week 10 compared between treatment groups.||0.41|-1.02|0.3987
91602588|NCT00330187|183097710|SUPERIORITY||Odds Ratio (OR)|3.6||||0.07|TWO_SIDED|95.0|0.9|14.4|||Regression, Logistic|||||14.4|0.9|0.07
91602589|NCT01751971|183097711|SUPERIORITY||Mean Difference (Net)|10.5||||0.4|TWO_SIDED|95.0|-16.0|37.1|||t-test, 2 sided||Positive estimated value would represent a greater reduction in AHI with oxygen (% sham) in the high vs low loop gain group.|"Primary statistical comparison was the percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %----between two phenotypic patient subgroups. Patient subgroups were defined by the loop gain (LG1) measured on the sham night as high or low (a priori cutoff LG1=0.7)."||37.1|-16|0.4
91602590|NCT01751971|183097711|SUPERIORITY||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|10.7|24.1|||t-test, 2 sided||Direction of comparison: Positive estimation parameter would indicate lower AHI on oxygen versus sham.|Here we aimed to confirm that there was a difference between AHI on oxygen vs sham (overall, i.e. in unselected patients). This test, however was not part of our primary objective.||24.1|10.7|<0.001
91786915|NCT00475982|183453492|SUPERIORITY|||||||0.162|||||||paired t-test|||intra-analysis within the weight loss arm||||0.162
91786916|NCT00475982|183453492|SUPERIORITY|||||||0.986|||||||paired t-test|||intra-analysis within the control arm||||0.986
91786917|NCT00475982|183453492|SUPERIORITY||Mean Difference (Net)|2.22||||0.353|TWO_SIDED|95.0|-2.58|7.02|||paired t-test|||analysis between the weight loss and control arms||7.02|-2.58|0.353
91786918|NCT00475982|183453493|SUPERIORITY|||||||0.283|||||||paired t-test|||intra-analysis within the weight loss arm||||0.283
91786919|NCT00475982|183453493|SUPERIORITY|||||||0.701|||||||paired t-test|||intra-analysis within the control arm||||0.701
91786920|NCT00475982|183453493|SUPERIORITY||Mean Difference (Net)|0.77||||0.835|TWO_SIDED|95.0|-6.7|8.24|||paired t-test|||analysis between the intervention and control arms||8.24|-6.70|0.835
91786921|NCT00475982|183453494|SUPERIORITY|||||||0|||||||paired t-test|||intra-analysis within the weight loss arm||||0.00
91786922|NCT00475982|183453494|SUPERIORITY|||||||0.009|||||||paired t-test|||intra-analysis within the control arm||||0.009
91786923|NCT00475982|183453494|SUPERIORITY||Mean Difference (Net)|2.11||||0.007|TWO_SIDED|95.0|0.64|3.59|||paired t-test|||analysis between the two arms||3.59|0.64|0.007
91786924|NCT00475982|183453495|SUPERIORITY|||||||0.073|||||||paired t-test|||intra-analysis within the weight loss arm||||0.073
91786925|NCT00475982|183453495|SUPERIORITY|||||||0.207|||||||paired t-test|||intra-analysis within the control arm||||0.207
91786926|NCT00475982|183453495|SUPERIORITY||Mean Difference (Net)|1.34||||0.063|TWO_SIDED|95.0|-0.08|2.75|||paired t-test|||analysis between the two arms||2.75|-0.08|0.063
91786927|NCT00743106|183453498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.15|TWO_SIDED|95.0|-31.0|9.0|||Wilcoxon (Mann-Whitney)||The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).|||9|-31|0.15
91786928|NCT00743106|183453499|SUPERIORITY||ratio of geometric mean|0.98||||0.78|TWO_SIDED|95.0|0.79|1.19|||Mixed Models Analysis|||We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.||1.19|0.79|0.78
91786929|NCT00029146|183453523|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.7||||0.78||95.0|-10.4|13.8|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.||13.8|-10.4|0.78
91786930|NCT00029146|183453524|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|3.5||||0.59|TWO_SIDED|95.0|-9.2|16.1|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors.||16.1|-9.2|0.59
91786931|NCT00029146|183453525|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-3.2||||0.27|TWO_SIDED|95.0|-9.0|2.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Negative indicates lower rate in non-surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||2.6|-9.0|0.27
91786932|NCT00029146|183453526|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.3||||0.5|TWO_SIDED|95.0|-2.5|5.2|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||5.2|-2.5|0.50
91786933|NCT00029146|183453527|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.0||||0.13|TWO_SIDED|95.0|-1.2|9.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||9.7|-1.2|0.13
91786934|NCT00029146|183453528|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|6.5||||0.33|TWO_SIDED|95.0|-6.5|19.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||19.6|-6.5|.33
91786935|NCT00029146|183453529|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-6.6||||0.41|TWO_SIDED|95.0|-20.6|7.3|||Fisher Exact||Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.|||7.3|-20.6|0.41
91786936|NCT00029146|183453530|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.4||||0.7|TWO_SIDED|95.0|-8.2|16.9|||Fisher Exact||Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.|||16.9|-8.2|0.70
91786937|NCT00029146|183453531|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher's Exact Test|||||||0.85
91786938|NCT00029146|183453532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.13|TWO_SIDED|95.0|-0.54|0.07|||t-test, 2 sided||Negative indicates lower score in non-surgical group.A higher score indicates better quality of life|||0.07|-0.54|0.13
91790559|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.159||0.901|TWO_SIDED|95.0|-0.294|0.333||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.333|-0.294|0.901
91523010|NCT00246337|182921407|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
91523011|NCT00246337|182921408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
91523012|NCT00246337|182921409|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
91523013|NCT00674570|182921411|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06|=|0.66|TWO_SIDED|95.0|-0.15|0.1|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.10|-.15|=.66
91650435|NCT02661126|183193539|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.54|||||TWO_SIDED|90.0|1.15|2.07||||||||2.07|1.15|
91650436|NCT01513551|183193544|OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|-1.4|15.0|||Miettinen & Nurminen|||||15.0|-1.4|
91650437|NCT01513551|183193544|OTHER||Risk Difference (RD)|9.5|||||TWO_SIDED|95.0|1.1|17.7|||Miettinen & Nurminen|||||17.7|1.1|
91650438|NCT02917447|183193551|SUPERIORITY|||||||0.15||||||Omnibus test for difference in change from baseline in PCL by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.15
91602591|NCT01751971|183097711|SUPERIORITY||Mean Difference (Net)|42.8||||0.001|TWO_SIDED|95.0|21.0|64.6|||t-test, 2 sided||Direction of comparison: Positive estimated value would indicate a greater percentage reduction in AHI (oxygen vs. sham) in favorable vs. unfavorable subgroups.|"The primary goal of the study was to identify a phenotypic subgroup of patients with sleep apnea that responds preferentially to oxygen (percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %). We defined patient subgroups (favorable versus unfavorable) based on the four key phenotypic traits (loop gain, collapsibility, arousal threshold, muscle responses) measured on the sham night, with the use of multiple logistic regression and leave-one-out cross validation."||64.6|21.0|0.001
91709489|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.74||||0.552|TWO_SIDED|95.0|0.29|1.92|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.92|0.29|0.5520
91602592|NCT01649947|183097717|OTHER||Mean Difference (Net)|56.0||||0.01|TWO_SIDED|95.0|8.9|72.0|||t-test, 2 sided|||The analysis is comprised of evaluable patients who had measureable disease and received at least one cycle of therapy and had disease evaluated.||72|8.9|0.01
91602593|NCT01162421|183097727|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3||||0.907|TWO_SIDED|95.0|-23.4|20.8|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||||20.8|-23.4|0.907
91602594|NCT01162421|183097728|SUPERIORITY_OR_OTHER||Difference in percentage|3.2||||0.762|TWO_SIDED|95.0|-17.7|24.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||24.1|-17.7|0.762
91602595|NCT01162421|183097728|SUPERIORITY_OR_OTHER||Difference in percentage|-5.3||||0.65|TWO_SIDED|95.0|-28.1|17.5|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||17.5|-28.1|0.650
91602596|NCT01162421|183097729|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.382||0.027|TWO_SIDED|95.0|-1.62|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 6||-0.10|-1.62|0.027
91602597|NCT01162421|183097729|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.667||0.033|TWO_SIDED|95.0|-2.79|-0.12||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 12||-0.12|-2.79|0.033
91602598|NCT01162421|183097729|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|1.403||0.12|TWO_SIDED|95.0|-5.05|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|||Month 24||0.60|-5.05|0.120
91602599|NCT01162421|183097730|SUPERIORITY_OR_OTHER||Difference in percentage|-11.7||||0.095|TWO_SIDED|95.0|-27.0|1.6||P-value is based on two sided Fisher's exact test.|Fisher Exact||Confidence interval is based on Wilson confidence limits.|||1.6|-27.0|0.095
91786939|NCT00029146|183453533|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.5||||0.81|TWO_SIDED|95.0|-10.7|13.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.||Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||13.7|-10.7|0.81
91523014|NCT00674570|182921411|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.41|TWO_SIDED|95.0|-0.17|0.07|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.07|-.17|=.41
91602600|NCT01162421|183097731|SUPERIORITY_OR_OTHER||Difference in percentage|12.1||||0.281|TWO_SIDED|95.0|-9.79|33.97|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.97|-9.79|0.281
91602601|NCT01162421|183097731|SUPERIORITY_OR_OTHER||Difference in percentage|27.0||||0.021|TWO_SIDED|95.0|4.98|48.93||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||48.93|4.98|0.021
91709490|NCT04378569|183311572|SUPERIORITY||Odds Ratio (OR)|0.69||||0.69|TWO_SIDED|95.0|0.21|2.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||2.20|0.21|0.69
91786940|NCT02663934|183453535|SUPERIORITY||Mean Difference (Net)|0.15||||0.31|TWO_SIDED|95.0|0.05|0.25|||ANOVA|||||.25|.05|0.31
91786941|NCT02663934|183453536|SUPERIORITY||Mean Difference (Net)|1.42||||0.24|TWO_SIDED||||||ANOVA|||Change in Global CBF in EXS vs. SIS||||.24
91786942|NCT02663934|183453536|OTHER||Slope|0.41||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Change in Strength \& Change in Frontal Brain Volume in EXS||||.02
91523015|NCT00674570|182921411|SUPERIORITY||Median Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.43|TWO_SIDED|95.0|-0.07|0.18|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.18|-.07|=.43
91523016|NCT00674570|182921411|SUPERIORITY||Median Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06|=|0.47|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.17|-.07|=.47
91523017|NCT00674570|182921411|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.05|=|0.065|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.20|-.01|=.065
91709491|NCT04378569|183311573|SUPERIORITY|Week 2|Mean Difference (Net)|-0.06||||0.6464|TWO_SIDED|95.0|-0.33|0.21|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.21|-0.33|0.6464
91786943|NCT02663934|183453536|OTHER||Slope|0.4||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Changes in Brain Volumes associated with changes Memory Performance in EXS||||0.02
91602602|NCT01162421|183097731|SUPERIORITY_OR_OTHER||Difference in percentage|6.7||||0.552|TWO_SIDED|95.0|-15.29|28.63|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||28.63|-15.29|0.552
91709492|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8881|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.25|-0.29|0.8881
91786944|NCT02663934|183453537|OTHER||Slope|0.47||||0.005|ONE_SIDED|95.0|||||Regression, Linear|||Increases in Time Spent in MVPA and Increased Learning Performance in EXS||||.005
91786945|NCT04556383|183453542|SUPERIORITY||Risk Difference (RD)|-2.6||||0.6694|TWO_SIDED|95.0|-15.2|10.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||10.2|-15.2|0.6694
91786946|NCT04556383|183453542|SUPERIORITY||Risk Difference (RD)|4.6||||0.4719|TWO_SIDED|95.0|-9.0|17.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.8|-9.0|0.4719
91786947|NCT04556383|183453544|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3263|TWO_SIDED|95.0|-23.2|8.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.3|-23.2|0.3263
91786948|NCT04556383|183453544|SUPERIORITY||Risk Difference (RD)|10.2||||0.2002|TWO_SIDED|95.0|-6.1|25.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||25.8|-6.1|0.2002
91786949|NCT04556383|183453545|SUPERIORITY||Risk Difference (RD)|0.4||||0.9472|TWO_SIDED|95.0|-15.2|15.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.9|-15.2|0.9472
91786950|NCT04556383|183453545|SUPERIORITY||Risk Difference (RD)|6.8||||0.3685|TWO_SIDED|95.0|-9.3|22.4|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.4|-9.3|0.3685
91786951|NCT04556383|183453546|SUPERIORITY||Risk Difference (RD)|1.3||||0.8484|TWO_SIDED|95.0|-12.7|15.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.2|-12.7|0.8484
91786952|NCT04556383|183453546|SUPERIORITY||Risk Difference (RD)|8.2||||0.2392|TWO_SIDED|95.0|-6.4|22.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.3|-6.4|0.2392
91786953|NCT04556383|183453547|SUPERIORITY||Risk Difference (RD)|-1.2||||0.8493|TWO_SIDED|95.0|-14.8|12.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||12.5|-14.8|0.8493
91786954|NCT04556383|183453547|SUPERIORITY||Risk Difference (RD)|2.6||||0.6647|TWO_SIDED|95.0|-11.5|16.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||16.5|-11.5|0.6647
91786955|NCT04556383|183453548|SUPERIORITY||Risk Difference (RD)|-6.5||||0.2263|TWO_SIDED|95.0|-19.1|6.0|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.0|-19.1|0.2263
91786956|NCT04556383|183453548|SUPERIORITY||Risk Difference (RD)|-1.4||||0.8259|TWO_SIDED|95.0|-14.8|12.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.2|-14.8|0.8259
91786957|NCT04556383|183453549|SUPERIORITY||Risk Difference (RD)|2.8||||0.7418|TWO_SIDED|95.0|-12.7|18.1|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||18.1|-12.7|0.7418
91786958|NCT04556383|183453549|SUPERIORITY||Risk Difference (RD)|8.4||||0.2758|TWO_SIDED|95.0|-7.8|24.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||24.2|-7.8|0.2758
91786959|NCT04556383|183453550|SUPERIORITY||Risk Difference (RD)|-6.0||||0.3504|TWO_SIDED|95.0|-20.6|8.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.9|-20.6|0.3504
91786960|NCT04556383|183453550|SUPERIORITY||Risk Difference (RD)|1.7||||0.8009|TWO_SIDED|95.0|-14.2|17.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.5|-14.2|0.8009
91786961|NCT04556383|183453551|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9474|TWO_SIDED|95.0|-14.3|13.7|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||13.7|-14.3|0.9474
91786962|NCT04556383|183453551|SUPERIORITY||Risk Difference (RD)|-3.0||||0.6409|TWO_SIDED|95.0|-16.6|10.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||10.8|-16.6|0.6409
91786963|NCT04556383|183453552|SUPERIORITY||Risk Difference (RD)|-8.0||||0.1932|TWO_SIDED|95.0|-22.4|6.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.3|-22.4|0.1932
91786964|NCT04556383|183453552|SUPERIORITY||Risk Difference (RD)|-2.3||||0.7459|TWO_SIDED|95.0|-17.6|12.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.9|-17.6|0.7459
91786965|NCT04784442|183453571|SUPERIORITY|The overall Type I error rate will be controlled by performing comparison versus the placebo group starting from the highest ETC 1002 dose group by a closed testing procedure at a two-sided significance level of 0.05.|Least squares mean difference|-19.35|STANDARD_ERROR_OF_MEAN|2.768|<|0.001|TWO_SIDED|95.0|-24.81|-13.88|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.88|-24.81|<0.001
91786966|NCT04784442|183453571|SUPERIORITY||Least squares mean difference|-19.93|STANDARD_ERROR_OF_MEAN|2.798|<|0.001|TWO_SIDED|95.0|-25.45|-14.41|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 120 mg arm minus the value for the placebo arm.|||-14.41|-25.45|<0.001
91786967|NCT04784442|183453571|SUPERIORITY||Least squares mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.813||0.002|TWO_SIDED|95.0|-14.22|-3.12|||ANCOVA||||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|-3.12|-14.22|0.002
91786968|NCT00509145|183453581|SUPERIORITY||Risk Ratio (RR)|0.77|STANDARD_ERROR_OF_MEAN|0.066||0.0024|TWO_SIDED|95.0|0.65|0.911|||Over-dispersed Poisson Regression||Laquinimod 0.6 mg vs. placebo|Response variable: number of relapses during 24 months. Offset based on the log of subject's exposure in years was employed to adjust for variability of treatment exposure. In addition to the treatment group, the Poisson regression model included the following covariates: baseline EDSS score, log of prior 2-year number of relapses+1 and Country or Geographical Region (CGR).||0.911|0.650|0.0024
91786969|NCT01994889|183453588|SUPERIORITY|||||||0.0006|||||||Finkelstein-Schoenfeld Method|||||||0.0006
91790560|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91602603|NCT01162421|183097731|SUPERIORITY_OR_OTHER||Difference in percentage|-12.2||||0.281|TWO_SIDED|95.0|-34.04|9.72|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||9.72|-34.04|0.281
91602604|NCT01162421|183097731|SUPERIORITY_OR_OTHER||Difference in percentage|-14.4||||0.209|TWO_SIDED|95.0|-36.64|7.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||7.78|-36.64|0.209
91602605|NCT01162421|183097731|SUPERIORITY_OR_OTHER||Difference in percentage|-19.6||||0.091|TWO_SIDED|95.0|-41.74|2.62|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||2.62|-41.74|0.091
91602606|NCT01162421|183097732|SUPERIORITY_OR_OTHER||Difference in percentage|15.6||||0.148|TWO_SIDED|95.0|-5.05|36.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||36.26|-5.05|0.148
91602607|NCT01162421|183097732|SUPERIORITY_OR_OTHER||Difference in percentage|20.7||||0.06|TWO_SIDED|95.0|-0.14|41.61|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.61|-0.14|0.060
91602608|NCT01162421|183097732|SUPERIORITY_OR_OTHER||Difference in percentage|8.7||||0.451|TWO_SIDED|95.0|-13.85|31.29|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||31.29|-13.85|0.451
91786970|NCT01994889|183453589|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0259|TWO_SIDED|95.0|0.508|0.958|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.958|0.508|0.0259
91786971|NCT01994889|183453590|SUPERIORITY||Risk Ratio (RR)|0.6761|||<|0.0001|TWO_SIDED|95.0|0.5639|0.8107||Poisson regression analysis with treatment, TTR genotype, NYHA baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors adjusted for treatment duration.|Poisson regression analysis|||||0.8107|0.5639|<0.0001
91602609|NCT01162421|183097732|SUPERIORITY_OR_OTHER||Difference in percentage|9.3||||0.413|TWO_SIDED|95.0|-12.82|31.43|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||31.43|-12.82|0.413
91786972|NCT01994889|183453591|SUPERIORITY||Least Square Mean Difference|75.68|STANDARD_ERROR_OF_MEAN|9.236|<|0.0001|TWO_SIDED|95.0|57.56|93.8|||Mixed Model Repeated Measures ANCOVA|||L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and participant within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.||93.80|57.56|<.0001
91602610|NCT01162421|183097732|SUPERIORITY_OR_OTHER||Difference in percentage|-7.3||||0.528|TWO_SIDED|95.0|-29.74|15.23|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||15.23|-29.74|0.528
91602611|NCT01162421|183097732|SUPERIORITY_OR_OTHER||Difference in percentage|-9.5||||0.399|TWO_SIDED|95.0|-31.61|12.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||12.56|-31.61|0.399
91602612|NCT01162421|183097733|SUPERIORITY_OR_OTHER||Difference in percentage|12.5||||0.111|TWO_SIDED|95.0|-1.7|27.06|||Fisher Exact|||Month 3||27.06|-1.70|0.111
91786973|NCT01994889|183453592|SUPERIORITY||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|9.48|17.83|||Mixed Model Repeated Measures ANCOVA|||Change at Month 30||17.83|9.48|<.0001
91786974|NCT01994889|183453593|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.0383|TWO_SIDED|95.0|0.488|0.98|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.980|0.488|0.0383
91786975|NCT01994889|183453594|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91786976|NCT01711216|183453613|SUPERIORITY_OR_OTHER|||||||0.3181|TWO_SIDED|||||Test statistic (d.f.) 1.0157 (1) A Mantel-Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.|Mantel Haenszel|||Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)||||0.3181
91786977|NCT02259088|183453615|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.8|||<|0.001|TWO_SIDED|95.0|4.1|7.5|||Cochran-Mantel-Haenszel|One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics.|Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and \> 60 letters) as factors.|||7.5|4.1|<0.001
91786978|NCT03060551|183453639|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.256||||||p value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.256
91786979|NCT03060551|183453640|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.682||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.682
91786980|NCT03060551|183453641|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.151||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.151
91786981|NCT03060551|183453642|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.516||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.516
91786982|NCT03060551|183453643|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.|||||>|0.999||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||>0.999
91523018|NCT00674570|182921411|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|=|0.34|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.15|-.05|=.34
91523019|NCT00674570|182921411|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.06|0.26|||Mixed Models Analysis|||Extinction End (last trial)||.26|.06|=.003
91523020|NCT00674570|182921411|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.02|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|||Extinction End (last trial)||.22|.02|.02
91602613|NCT01162421|183097733|SUPERIORITY_OR_OTHER||Difference in percentage|19.6||||0.031|TWO_SIDED|95.0|2.74|36.53||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||36.53|2.74|0.031
91602614|NCT01162421|183097733|SUPERIORITY_OR_OTHER||Difference in percentage|2.8||||0.78|TWO_SIDED|95.0|-16.74|22.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||22.31|-16.74|0.780
91602615|NCT01162421|183097733|SUPERIORITY_OR_OTHER||Difference in percentage|16.5||||0.092|TWO_SIDED|95.0|-2.07|35.04|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||35.04|-2.07|0.092
91602616|NCT01162421|183097733|SUPERIORITY_OR_OTHER||Difference in percentage|10.8||||0.29|TWO_SIDED|95.0|-8.86|30.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||30.40|-8.86|0.290
91602617|NCT01162421|183097733|SUPERIORITY_OR_OTHER||Difference in percentage|-16.9||||0.116|TWO_SIDED|95.0|-37.86|4.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||4.01|-37.86|0.116
91602618|NCT01162421|183097734|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.9|-1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 3||-1.2|-5.9|0.004
91602619|NCT01162421|183097734|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.8|-2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-2.3|-6.8|<0.001
91602620|NCT01162421|183097734|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.16||0.021|TWO_SIDED|95.0|-5.1|-0.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.4|-5.1|0.021
91786983|NCT03060551|183453644|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.034||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.034
91602621|NCT01162421|183097734|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.96||0.037|TWO_SIDED|95.0|-4.0|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.1|-4.0|0.037
91602622|NCT01162421|183097734|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.58||0.702|TWO_SIDED|95.0|-3.7|2.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.5|-3.7|0.702
91786984|NCT03060551|183453645|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.656||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.656
91786985|NCT03060551|183453646|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.096||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.096
91786986|NCT03060551|183453647|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.019||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.019
91786987|NCT03060551|183453648|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.05||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.050
91786988|NCT03060551|183453649|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
91786989|NCT03060551|183453650|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.024||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.024
91786990|NCT03060551|183453651|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.188||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.188
91786991|NCT03060551|183453652|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
91523021|NCT00674570|182921411|OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06|=|0.006|TWO_SIDED|95.0|0.05|0.3|||Mixed Models Analysis|||Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.||.30|.05|=.006
91523022|NCT00674570|182921411|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06|=|0.01|TWO_SIDED|95.0|0.04|0.28|||Mixed Models Analysis|||Extinction retention||.28|.04|=.01
91602623|NCT01162421|183097734|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.15||0.644|TWO_SIDED|95.0|-2.8|1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.8|-2.8|0.644
91523023|NCT02798211|182921421|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0011|TWO_SIDED|95.0|1.65|7.45|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||7.45|1.65|0.0011
91786992|NCT03060551|183453653|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.633||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.633
91786993|NCT03060551|183453654|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.38||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.380
91786994|NCT03698591|183453673|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
91786995|NCT03698591|183453673|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distancing performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
91786996|NCT03698591|183453673|OTHER||t-statistic|-1.656||||0.108|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distancing performance between study periods 1 and 2. The null hypothesis was that distancing performance would not differ by study period.||||.108
91786997|NCT03698591|183453673|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
91786998|NCT03698591|183453674|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
91786999|NCT03698591|183453674|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
91787000|NCT03698591|183453674|OTHER||t-statistic|2.694||||0.012|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test a potential effect of study period on distancing effort.||||.012
91787001|NCT03698591|183453674|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
91787002|NCT03698591|183453674|OTHER||F-statistic|7.162||||0.013|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distancing effort. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.013
91787003|NCT03698591|183453675|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
91787004|NCT03698591|183453675|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distraction performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
91787005|NCT03698591|183453675|OTHER||t-statistic|1.282||||0.21|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distraction performance between study periods 1 and 2. The null hypothesis was that distraction performance would not differ by study period.||||.210
91787006|NCT03698591|183453675|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
91787007|NCT03698591|183453676|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
91787008|NCT03698591|183453676|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
91523024|NCT02798211|182921421|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0961|TWO_SIDED|95.0|0.89|4.15|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||4.15|0.89|0.0961
91523025|NCT02798211|182921422|SUPERIORITY||Odds Ratio (OR)|0.6||||0.333|TWO_SIDED|95.0|0.22|1.68|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, 16 weeks||1.68|0.22|0.3330
91523026|NCT02798211|182921422|SUPERIORITY||Odds Ratio (OR)|0.4||||0.0841|TWO_SIDED|95.0|0.14|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||1.13|0.14|0.0841
91787009|NCT03698591|183453676|OTHER||t-statistic|0.828||||0.415|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test the effect of study period on distraction effort.||||.415
91523027|NCT02798211|182921423|SUPERIORITY||Odds Ratio (OR)|0.52||||0.1618|TWO_SIDED|95.0|0.21|1.3|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||1.30|0.21|0.1618
91787010|NCT03698591|183453676|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
91787011|NCT03698591|183453676|OTHER||F-statistic|0.396||||0.535|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distraction performance. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.535
91787012|NCT03009396|183453679|SUPERIORITY|||||||0.2112|||||||Log Rank|||||||0.2112
91787013|NCT03009396|183453680|SUPERIORITY|||||||0.0356|||||||Log Rank|||||||0.0356
91787014|NCT03009396|183453681|SUPERIORITY|||||||0.0514|||||||Log Rank|||||||0.0514
91787015|NCT03009396|183453682|SUPERIORITY|||||||0.1259|||||||Log Rank|||||||0.1259
91787016|NCT03009396|183453683|SUPERIORITY|||||||0.4114|||||||Fisher Exact|||||||0.4114
91787017|NCT02660983|183453690|SUPERIORITY||Difference in least square (LS) means|-0.58||||0.3455|TWO_SIDED|95.0|-1.79|0.63|||ANCOVA|||||0.63|-1.79|0.3455
91787018|NCT02660983|183453691|SUPERIORITY||Difference in LS means|-0.12||||0.257|TWO_SIDED|95.0|-0.32|0.09|||ANCOVA||LS mean of Donepezil group - LS mean of Placebo (when the difference of LS mean scores were less than 0, considered as demonstrated hypothesis), analyzed with ANCOVA model with baseline (CIBIS) as covariate and treatment as main effect.|||0.09|-0.32|0.2570
91787019|NCT02660983|183453692|SUPERIORITY||Difference in LS means|0.65||||0.0396|TWO_SIDED|95.0|0.03|1.26|||ANCOVA|||||1.26|0.03|0.0396
91787020|NCT02660983|183453693|SUPERIORITY||Difference in LS means|-7.73||||0.2213|TWO_SIDED|95.0|-20.13|4.68|||ANCOVA|||Part A||4.68|-20.13|0.2213
91787021|NCT02660983|183453693|SUPERIORITY||Difference in LS means|-14.88||||0.0551|TWO_SIDED|95.0|-30.1|0.33|||ANCOVA|||Part B||0.33|-30.10|0.0551
91787022|NCT03376295|183453716|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.2|||Cox proportional hazards model||The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.20|0.90|
91787023|NCT03376295|183453716|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.65|1.36|||Cox proportional hazards model||HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.36|0.65|
91787024|NCT03376295|183453717|OTHER||Rate ratio (RR)|1.07|||||TWO_SIDED|95.0|0.92|1.25|||Negative binomial model||The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Moderate/severe exacerbation||1.25|0.92|
91787025|NCT03376295|183453717|OTHER||Rate ratio (RR)|0.85|||||TWO_SIDED|95.0|0.55|1.33|||Negative binomial model||The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Severe exacerbation||1.33|0.55|
91787026|NCT03376295|183453718|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.42|1.05|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.05|0.42|
91787027|NCT03376295|183453718|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.48|0.92|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||0.92|0.48|
91787028|NCT00893815|183453719|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.1||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|||1.10|0.27|0.09
91787029|NCT00893815|183453720|OTHER||Odds Ratio (OR)|0.75||||0.45|TWO_SIDED|95.0|0.35|1.61||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of verbal fluency impairment between HIV-positive and HIV-negative military beneficiaries||1.61|0.35|0.45
91787030|NCT00893815|183453720|OTHER||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.35|1.56||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiaries||1.56|0.35|0.43
91787031|NCT00893815|183453720|OTHER||Odds Ratio (OR)|1.45||||0.56|TWO_SIDED|95.0|0.41|5.17||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiaries||5.17|0.41|0.56
91602624|NCT01162421|183097735|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.89||0.039|TWO_SIDED|95.0|-3.7|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-0.1|-3.7|0.039
91602625|NCT01162421|183097735|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-5.0|-1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.8|-5.0|<0.001
91602626|NCT01162421|183097735|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.008|TWO_SIDED|95.0|-3.8|-0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 9||-0.6|-3.8|0.008
91602627|NCT01162421|183097735|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.71||0.028|TWO_SIDED|95.0|-3.0|-0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.2|-3.0|0.028
91602628|NCT01162421|183097735|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.94||0.452|TWO_SIDED|95.0|-2.6|1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||1.2|-2.6|0.452
91787032|NCT00893815|183453720|OTHER||Odds Ratio (OR)|1.32||||0.49|TWO_SIDED|95.0|0.6|2.93||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiaries||2.93|0.60|0.49
91787033|NCT00893815|183453720|OTHER||Odds Ratio (OR)|0.43||||0.01|TWO_SIDED|95.0|0.22|0.84||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiaries||0.84|0.22|0.01
91602629|NCT01162421|183097735|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.343|TWO_SIDED|95.0|-2.3|0.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.8|-2.3|0.343
91602630|NCT01162421|183097736|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.26||0.22|TWO_SIDED|95.0|-7.3|1.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||1.7|-7.3|0.220
91602631|NCT01162421|183097736|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-11.0|-3.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-3.3|-11.0|<0.001
91602632|NCT01162421|183097736|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.05|TWO_SIDED|95.0|-7.5|0.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||0.0|-7.5|0.050
91602633|NCT01162421|183097736|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.95||0.725|TWO_SIDED|95.0|-4.6|3.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||3.2|-4.6|0.725
91787034|NCT00893815|183453720|OTHER||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.34||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiaries||3.34|0.58|0.46
91602634|NCT01162421|183097736|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.31||0.837|TWO_SIDED|95.0|-5.1|4.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||4.1|-5.1|0.837
91709493|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.436|TWO_SIDED|95.0|-0.2|0.46|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.46|-0.20|0.4360
91709494|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.8196|TWO_SIDED|95.0|-0.29|0.36|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.36|-0.29|0.8196
91787035|NCT00893815|183453720|OTHER||Odds Ratio (OR)|0.89||||0.76|TWO_SIDED|95.0|0.43|1.85||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of motor speed \& dexterity impairment between HIV-positive and HIV-negative military beneficiaries||1.85|0.43|0.76
91787036|NCT06457204|183453736|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.4|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 6.9."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.4|
91787037|NCT06457204|183453737|OTHER||Ratio of adjusted geometric means [%]|98.3|||||TWO_SIDED|90.0|91.6|105.5|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 15.0."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.5|91.6|
91787038|NCT06457204|183453738|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.2|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.1."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.2|
91787039|NCT01457352|183453739|SUPERIORITY|||||||0.2062|||||||Cochran-Mantel-Haenszel|||||||0.2062
91787040|NCT01457352|183453740|SUPERIORITY|||||||0.0485|||||||Mantel Haenszel|||||||0.0485
91787041|NCT02712047|183453741|OTHER||Ratio|0.36|||||TWO_SIDED|95.0|0.31|0.43|||||Ratio of FF/VI 100/25mcg versus (Vs) Placebo for Day 1, AM|||0.43|0.31|
91787042|NCT02712047|183453741|OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.39|0.28|
91787043|NCT02712047|183453741|OTHER||Ratio|0.38|||||TWO_SIDED|95.0|0.32|0.45|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.45|0.32|
91787044|NCT02712047|183453741|OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.31|0.44|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.44|0.31|
91787045|NCT02712047|183453741|OTHER||Ratio|0.46|||||TWO_SIDED|95.0|0.39|0.54|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.54|0.39|
91787046|NCT02712047|183453741|OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.4|0.56|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.56|0.40|
91787047|NCT02712047|183453741|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.66|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.66|0.47|
91787048|NCT02712047|183453741|OTHER||Ratio|0.58|||||TWO_SIDED|95.0|0.49|0.69|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.69|0.49|
91787049|NCT02712047|183453741|OTHER||Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.75|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.75|0.53|
91787050|NCT02712047|183453741|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||0.80|0.57|
91787051|NCT02712047|183453741|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||0.80|0.56|
91787052|NCT02712047|183453741|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||0.74|0.52|
91787053|NCT02712047|183453741|OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.71|0.51|
91787054|NCT02712047|183453741|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, PM|Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM||0.74|0.52|
91787055|NCT02712047|183453741|OTHER||Ratio|0.69|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||0.81|0.58|
91787056|NCT02712047|183453741|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||0.80|0.57|
91787057|NCT02712047|183453741|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.56|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||0.78|0.56|
91787058|NCT02712047|183453741|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||0.80|0.57|
91787059|NCT02712047|183453741|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||0.78|0.55|
91787060|NCT02712047|183453741|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||0.81|0.58|
91787061|NCT02712047|183453741|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||0.86|0.61|
91787062|NCT02712047|183453741|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||0.86|0.61|
91787063|NCT02712047|183453741|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.85|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||0.85|0.61|
91602635|NCT01162421|183097736|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.83||0.661|TWO_SIDED|95.0|-4.5|2.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||2.9|-4.5|0.661
91602636|NCT01162421|183097737|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.156|TWO_SIDED|95.0|-4.4|0.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.7|-4.4|0.156
91523028|NCT02798211|182921423|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0898|TWO_SIDED|95.0|0.19|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||1.13|0.19|0.0898
91787064|NCT02712047|183453741|OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||0.84|0.60|
91787065|NCT02712047|183453741|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||0.86|0.61|
91787066|NCT02712047|183453741|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||0.93|0.66|
91787067|NCT02712047|183453741|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||0.93|0.66|
91787068|NCT02712047|183453741|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.79|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||0.79|0.56|
91787069|NCT02712047|183453741|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||0.93|0.66|
91787070|NCT02712047|183453741|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||0.94|0.66|
91787071|NCT02712047|183453741|OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.87|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||0.87|0.62|
91787072|NCT02712047|183453741|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||0.86|0.61|
91787073|NCT02712047|183453741|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||0.91|0.65|
91787074|NCT02712047|183453741|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.01|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||1.01|0.65|
91787075|NCT02712047|183453741|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||0.96|0.61|
91787076|NCT02712047|183453741|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.59|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||1.00|0.59|
91787077|NCT02712047|183453741|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.05|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||1.05|0.63|
91787078|NCT02712047|183453741|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.52|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||1.00|0.52|
91787079|NCT02712047|183453741|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.56|1.09|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||1.09|0.56|
91787080|NCT02712047|183453741|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.53|1.14|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||1.14|0.53|
91787081|NCT02712047|183453741|OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.59|1.22|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||1.22|0.59|
91787082|NCT02712047|183453741|OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.5|1.13|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||1.13|0.50|
91787083|NCT02712047|183453741|OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.55|1.25|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, AM|||1.25|0.55|
91787084|NCT02712047|183453741|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.16|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, PM|||1.16|0.51|
91787085|NCT02712047|183453741|OTHER||Ratio|0.99|||||TWO_SIDED|95.0|0.66|1.49|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, AM|||1.49|0.66|
91787086|NCT02712047|183453741|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.29|1.51|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, PM|||1.51|0.29|
91787087|NCT02712047|183453741|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.32|1.64|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 24, AM|||1.64|0.32|
91787088|NCT02712047|183453743|OTHER||Mean Difference (Net)|45.86|||||TWO_SIDED|95.0|23.69|68.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||68.03|23.69|
91787089|NCT02712047|183453743|OTHER||Mean Difference (Net)|45.37|||||TWO_SIDED|95.0|23.2|67.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||67.55|23.20|
91787090|NCT02712047|183453743|OTHER||Mean Difference (Net)|34.03|||||TWO_SIDED|95.0|11.86|56.21|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||56.21|11.86|
91787091|NCT02712047|183453743|OTHER||Mean Difference (Net)|31.56|||||TWO_SIDED|95.0|9.38|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||53.73|9.38|
91787092|NCT02712047|183453743|OTHER||Mean Difference (Net)|22.86|||||TWO_SIDED|95.0|0.68|45.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||45.03|0.68|
91787093|NCT02712047|183453743|OTHER||Mean Difference (Net)|36.94|||||TWO_SIDED|95.0|14.77|59.12|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||59.12|14.77|
91787094|NCT02712047|183453743|OTHER||Mean Difference (Net)|19.33|||||TWO_SIDED|95.0|-3.0|41.66|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||41.66|-3.00|
91787095|NCT02712047|183453743|OTHER||Mean Difference (Net)|20.85|||||TWO_SIDED|95.0|-1.32|43.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||43.03|-1.32|
91787096|NCT02712047|183453743|OTHER||Mean Difference (Net)|16.82|||||TWO_SIDED|95.0|-5.47|39.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||39.11|-5.47|
91787097|NCT02712047|183453743|OTHER||Mean Difference (Net)|21.86|||||TWO_SIDED|95.0|-0.41|44.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||44.14|-0.41|
91787098|NCT02712047|183453743|OTHER||Mean Difference (Net)|13.05|||||TWO_SIDED|95.0|-9.57|35.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||35.67|-9.57|
91787099|NCT02712047|183453743|OTHER||Mean Difference (Net)|28.68|||||TWO_SIDED|95.0|5.38|51.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||51.98|5.38|
91787100|NCT02712047|183453743|OTHER||Mean Difference (Net)|17.09|||||TWO_SIDED|95.0|-5.08|39.26|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||39.26|-5.08|
91787101|NCT02712047|183453743|OTHER||Mean Difference (Net)|23.61|||||TWO_SIDED|95.0|0.28|46.94|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, PM|||46.94|0.28|
91787102|NCT02712047|183453743|OTHER||Mean Difference (Net)|12.87|||||TWO_SIDED|95.0|-9.3|35.05|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||35.05|-9.30|
91787103|NCT02712047|183453743|OTHER||Mean Difference (Net)|7.5|||||TWO_SIDED|95.0|-14.67|29.68|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||29.68|-14.67|
91523029|NCT02798211|182921424|SUPERIORITY||Odds Ratio (OR)|0.27||||0.0125|TWO_SIDED|95.0|0.09|0.75|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.75|0.09|0.0125
91523030|NCT02798211|182921424|SUPERIORITY||Odds Ratio (OR)|0.25||||0.0086|TWO_SIDED|95.0|0.09|0.7|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.70|0.09|0.0086
91523031|NCT02798211|182921425|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0338|TWO_SIDED|95.0|0.13|0.92|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.92|0.13|0.0338
91523032|NCT02798211|182921425|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0359|TWO_SIDED|95.0|0.14|0.93|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.93|0.14|0.0359
91523033|NCT02798211|182921426|SUPERIORITY||Odds Ratio, log|6.3||||0.0038|TWO_SIDED|95.0|1.81|21.88|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||21.88|1.81|0.0038
91523034|NCT02798211|182921426|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0149|TWO_SIDED|95.0|1.36|16.77|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.77|1.36|0.0149
91523035|NCT02798211|182921427|SUPERIORITY||Odds Ratio, log|10.5||||0.0243|TWO_SIDED|95.0|1.36|81.3|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||81.30|1.36|0.0243
91523036|NCT02798211|182921427|SUPERIORITY||Odds Ratio (OR)|5.42||||0.112|TWO_SIDED|95.0|0.67|43.64|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||43.64|0.67|0.1120
91523037|NCT02798211|182921428|SUPERIORITY||Odds Ratio, log|9.49|||<|0.0001|TWO_SIDED|95.0|3.73|24.16|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||24.16|3.73|<0.0001
91787104|NCT02712047|183453743|OTHER||Mean Difference (Net)|3.32|||||TWO_SIDED|95.0|-19.11|25.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||25.74|-19.11|
91787105|NCT02712047|183453743|OTHER||Mean Difference (Net)|3.83|||||TWO_SIDED|95.0|-18.34|26.0|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||26.00|-18.34|
91787106|NCT02712047|183453743|OTHER||Mean Difference (Net)|11.36|||||TWO_SIDED|95.0|-11.11|33.82|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||33.82|-11.11|
91787107|NCT02712047|183453743|OTHER||Mean Difference (Net)|27.73|||||TWO_SIDED|95.0|5.43|50.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||50.03|5.43|
91787108|NCT02712047|183453743|OTHER||Mean Difference (Net)|14.71|||||TWO_SIDED|95.0|-7.57|36.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||36.98|-7.57|
91787109|NCT02712047|183453743|OTHER||Mean Difference (Net)|-6.62|||||TWO_SIDED|95.0|-28.8|15.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||15.55|-28.80|
91787110|NCT02712047|183453743|OTHER||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-18.39|27.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||27.11|-18.39|
91787111|NCT02712047|183453743|OTHER||Mean Difference (Net)|8.29|||||TWO_SIDED|95.0|-13.99|30.57|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||30.57|-13.99|
91787112|NCT02712047|183453743|OTHER||Mean Difference (Net)|0.64|||||TWO_SIDED|95.0|-21.64|22.92|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||22.92|-21.64|
91787113|NCT02712047|183453743|OTHER||Mean Difference (Net)|-6.88|||||TWO_SIDED|95.0|-29.96|16.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||16.19|-29.96|
91787114|NCT02712047|183453743|OTHER||Mean Difference (Net)|28.45|||||TWO_SIDED|95.0|5.76|51.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||51.13|5.76|
91787115|NCT02712047|183453743|OTHER||Mean Difference (Net)|12.31|||||TWO_SIDED|95.0|-10.13|34.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||34.74|-10.13|
91787116|NCT02712047|183453743|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-18.16|26.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||26.36|-18.16|
91787117|NCT02712047|183453743|OTHER||Mean Difference (Net)|18.87|||||TWO_SIDED|95.0|-3.89|41.63|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||41.63|-3.89|
91787118|NCT02712047|183453743|OTHER||Mean Difference (Net)|6.35|||||TWO_SIDED|95.0|-16.17|28.88|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||28.88|-16.17|
91787119|NCT02712047|183453743|OTHER||Mean Difference (Net)|19.07|||||TWO_SIDED|95.0|-3.27|41.41|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||41.41|-3.27|
91787120|NCT02712047|183453743|OTHER||Mean Difference (Net)|29.51|||||TWO_SIDED|95.0|6.87|52.15|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||52.15|6.87|
91787121|NCT02712047|183453743|OTHER||Mean Difference (Net)|9.64|||||TWO_SIDED|95.0|-17.91|37.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||37.19|-17.91|
91787122|NCT02712047|183453743|OTHER||Mean Difference (Net)|24.77|||||TWO_SIDED|95.0|-4.2|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||53.73|-4.20|
91787123|NCT02712047|183453743|OTHER||Mean Difference (Net)|47.04|||||TWO_SIDED|95.0|14.63|79.45|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||79.45|14.63|
91787124|NCT02712047|183453743|OTHER||Mean Difference (Net)|20.11|||||TWO_SIDED|95.0|-12.3|52.52|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||52.52|-12.30|
91787125|NCT02712047|183453743|OTHER||Mean Difference (Net)|25.13|||||TWO_SIDED|95.0|-15.02|65.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||65.27|-15.02|
91787126|NCT02712047|183453743|OTHER||Mean Difference (Net)|-7.89|||||TWO_SIDED|95.0|-48.04|32.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||32.25|-48.04|
91787127|NCT02712047|183453743|OTHER||Mean Difference (Net)|8.51|||||TWO_SIDED|95.0|-37.22|54.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||54.25|-37.22|
91787128|NCT02712047|183453743|OTHER||Mean Difference (Net)|15.08|||||TWO_SIDED|95.0|-28.5|58.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||58.67|-28.50|
91787129|NCT02712047|183453743|OTHER||Mean Difference (Net)|5.19|||||TWO_SIDED|95.0|-45.35|55.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||55.73|-45.35|
91602637|NCT01162421|183097737|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-6.1|-1.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.9|-6.1|<0.001
91602638|NCT01162421|183097737|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.19||0.04|TWO_SIDED|95.0|-4.9|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.1|-4.9|0.040
91602639|NCT01162421|183097737|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.14||0.492|TWO_SIDED|95.0|-3.1|1.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||1.5|-3.1|0.492
91602640|NCT01162421|183097737|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.649|TWO_SIDED|95.0|-3.2|2.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.0|-3.2|0.649
91787130|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|0.26|0.46|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||0.46|0.26|
91787131|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.36|0.16|
91787132|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.34|||||TWO_SIDED|95.0|0.24|0.44|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.44|0.24|
91787133|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.34|0.14|
91787134|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.36|0.16|
91787135|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.18|||||TWO_SIDED|95.0|0.08|0.28|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.28|0.08|
91787136|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.34|0.14|
91787137|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|0.07|0.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.27|0.07|
91787138|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.03|0.17|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.17|-0.03|
91787139|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.06|0.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.14|-0.06|
91602641|NCT01162421|183097737|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.464|TWO_SIDED|95.0|-3.0|1.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.4|-3.0|0.464
91787140|NCT02712047|183453744|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.07|0.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||0.13|-0.07|
91787141|NCT02908490|183453766|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline FMD within that period and a term for treatment order.|Slope|-1.42||||0.185|TWO_SIDED|95.0|-3.54|0.68||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.68|-3.54|0.185
91787142|NCT02908490|183453767|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline EndoPAT within that period and a term for treatment order.|Slope|0.2||||0.003|TWO_SIDED|95.0|0.069|0.331||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.331|0.069|0.003
91787143|NCT02908490|183453773|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|7.63||||0.061|TWO_SIDED|95.0|-0.36|15.63||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||15.63|-0.36|0.061
91787144|NCT02908490|183453774|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|55.3||||0.011|TWO_SIDED|95.0|12.79|97.81||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||97.81|12.79|0.011
91787145|NCT02908490|183453775|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|74.93||||0.077|TWO_SIDED|95.0|-7.98|157.84||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||157.84|-7.98|0.077
91787146|NCT01122264|183453784|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66|||<|0.001|TWO_SIDED|97.3|0.51|0.85||P-value: Tadalafil Once a Day versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.85|0.51|<0.001
91787147|NCT01122264|183453784|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.49|||<|0.001|TWO_SIDED|97.3|0.37|0.65||P-value: Tadalafil On Demand versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.65|0.37|<0.001
91787148|NCT01122264|183453784|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.033|TWO_SIDED|95.0|1.02|1.71||P-value: Tadalafil On Demand versus Tadalafil Once a Day treatment groups using Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||1.71|1.02|0.033
91787149|NCT00097981|183453802|SUPERIORITY_OR_OTHER|||||||0.49|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.49
91787150|NCT00097981|183453803|SUPERIORITY_OR_OTHER|||||||0.42|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.42
91787151|NCT00097981|183453804|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Log Rank|||||||0.42
91787152|NCT00097981|183453805|SUPERIORITY_OR_OTHER|||||||0.5162||95.0|||||Log Rank|||||||0.5162
91787153|NCT00097981|183453806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.93|TWO_SIDED|95.0|0.529|1.797|||Log Rank|Stratified log-rank test||||1.797|0.529|0.93
91787154|NCT00913458|183453840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.7|12.5||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||12.5|2.7|<0.0001
91787155|NCT00913458|183453840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0085|TWO_SIDED|95.0|1.3|5.3||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.3|1.3|0.0085
91787156|NCT00913458|183453840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0397|TWO_SIDED|95.0|1.0|4.8||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Linear|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|1.0|0.0397
91787157|NCT00913458|183453841|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~End of Phase 1"||||<0.0001
91787158|NCT00913458|183453842|SUPERIORITY_OR_OTHER|||||||0.1183|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.1183
91787159|NCT00913458|183453842|SUPERIORITY_OR_OTHER|||||||0.0286|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0286
91787160|NCT00913458|183453843|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
91787161|NCT00913458|183453844|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
91787162|NCT00913458|183453845|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13"||||0.0063
91787163|NCT00913458|183453845|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 26"||||0.0053
91602642|NCT01162421|183097738|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|5.08||0.018|TWO_SIDED|95.0|-22.5|-2.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-2.2|-22.5|0.018
91602643|NCT01162421|183097738|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-37.3|-13.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-13.7|-37.3|<0.001
91602644|NCT01162421|183097738|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|5.84||0.113|TWO_SIDED|95.0|-21.0|2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||2.3|-21.0|0.113
91602645|NCT01162421|183097738|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|5.72||0.544|TWO_SIDED|95.0|-14.9|7.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||7.9|-14.9|0.544
91602646|NCT01162421|183097738|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.96||0.916|TWO_SIDED|95.0|-12.5|11.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||11.2|-12.5|0.916
91602647|NCT01162421|183097738|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.86||0.983|TWO_SIDED|95.0|-11.8|11.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||11.6|-11.8|0.983
91602648|NCT01162421|183097739|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.96||0.641|TWO_SIDED|95.0|-12.2|7.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.6|-12.2|0.641
91602649|NCT01162421|183097739|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.61||0.358|TWO_SIDED|95.0|-16.4|6.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||6.0|-16.4|0.358
91602650|NCT01162421|183097739|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|5.58||0.352|TWO_SIDED|95.0|-5.9|16.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||16.4|-5.9|0.352
91602651|NCT01162421|183097739|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|5.28||0.99|TWO_SIDED|95.0|-10.5|10.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||10.6|-10.5|0.990
91787164|NCT00913458|183453845|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 39"||||0.0027
91787165|NCT00913458|183453845|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.0002
91602652|NCT01162421|183097739|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|5.36||0.238|TWO_SIDED|95.0|-4.3|17.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||17.1|-4.3|0.238
91602653|NCT01162421|183097739|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.54||0.207|TWO_SIDED|95.0|-4.0|18.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||18.1|-4.0|0.207
91602654|NCT01162421|183097740|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.28||0.85|TWO_SIDED|95.0|-11.5|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||9.5|-11.5|0.850
91602655|NCT01162421|183097740|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|5.49||0.129|TWO_SIDED|95.0|-19.4|2.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.5|-19.4|0.129
91650439|NCT02917447|183193552|SUPERIORITY|||||||0.049||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||.049
91650440|NCT02917447|183193553|SUPERIORITY|||||||0.92||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.92
91650441|NCT01706198|183193555|OTHER||Adjusted Odds Ratio|2.0|||<|0.001|TWO_SIDED|95.0|1.7|2.34||The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care has been presented.|||2.34|1.70|<0.001
91787166|NCT00913458|183453845|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0005
91787167|NCT00913458|183453846|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
91602656|NCT01162421|183097740|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.62||0.937|TWO_SIDED|95.0|-10.8|11.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||11.6|-10.8|0.937
91602657|NCT01162421|183097740|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.59||0.67|TWO_SIDED|95.0|-13.5|8.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||8.8|-13.5|0.670
91602658|NCT01162421|183097740|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|5.67||0.341|TWO_SIDED|95.0|-5.9|16.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||16.7|-5.9|0.341
91650442|NCT01706198|183193556|OTHER||Adjusted Odds Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.67|2.2||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.|||2.20|1.67|<0.001
91787168|NCT00913458|183453847|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
91787169|NCT00913458|183453848|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
91787170|NCT00913458|183453849|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
91602659|NCT01162421|183097740|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|6.13||0.621|TWO_SIDED|95.0|-9.2|15.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||15.3|-9.2|0.621
91602660|NCT01162421|183097741|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.29||0.697|TWO_SIDED|95.0|-5.3|7.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.9|-5.3|0.697
91602661|NCT01162421|183097741|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.51||0.744|TWO_SIDED|95.0|-10.5|7.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.5|-10.5|0.744
91602662|NCT01162421|183097741|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.95||0.967|TWO_SIDED|95.0|-7.7|8.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.0|-7.7|0.967
91602663|NCT01162421|183097741|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.3||0.377|TWO_SIDED|95.0|-3.7|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||9.5|-3.7|0.377
91602664|NCT01162421|183097741|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.5||0.122|TWO_SIDED|95.0|-1.5|12.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||12.4|-1.5|0.122
91602665|NCT01162421|183097741|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|3.42||0.49|TWO_SIDED|95.0|-4.4|9.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.2|-4.4|0.490
91602666|NCT01162421|183097742|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.102|TWO_SIDED|95.0|-1.0|0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.1|-1.0|0.102
91602667|NCT01162421|183097742|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|95.0|-1.5|-0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||-0.3|-1.5|0.003
91602668|NCT01162421|183097742|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.214|TWO_SIDED|95.0|-0.9|0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||0.2|-0.9|0.214
91602669|NCT01162421|183097742|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.339|TWO_SIDED|95.0|-0.8|0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||0.3|-0.8|0.339
91602670|NCT01162421|183097742|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.973|TWO_SIDED|95.0|-0.6|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||0.6|-0.6|0.973
91602671|NCT01162421|183097742|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.755|TWO_SIDED|95.0|-0.6|0.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.5|-0.6|0.755
91602672|NCT01162421|183097743|SUPERIORITY_OR_OTHER||Difference in percentage|9.4||||0.316|TWO_SIDED|95.0|-7.09|25.13|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||25.13|-7.09|0.316
91602673|NCT01162421|183097743|SUPERIORITY_OR_OTHER||Difference in percentage|24.5||||0.014|TWO_SIDED|95.0|6.09|42.85|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||42.85|6.09|0.014
91602674|NCT01162421|183097743|SUPERIORITY_OR_OTHER||Difference in percentage|-3.2||||0.762|TWO_SIDED|95.0|-24.1|17.66|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||17.66|-24.10|0.762
91787171|NCT00913458|183453850|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
91602675|NCT01162421|183097743|SUPERIORITY_OR_OTHER||Difference in percentage|13.0||||0.22|TWO_SIDED|95.0|-7.46|33.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||33.54|-7.46|0.220
91602676|NCT01162421|183097743|SUPERIORITY_OR_OTHER||Difference in percentage|-3.5||||0.747|TWO_SIDED|95.0|-24.9|17.86|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||17.86|-24.90|0.747
91602677|NCT01162421|183097743|SUPERIORITY_OR_OTHER||Difference in percentage|-4.4||||0.701|TWO_SIDED|95.0|-26.8|18.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||18.01|-26.80|0.701
91602678|NCT01162421|183097744|SUPERIORITY_OR_OTHER||Difference in percentage|10.5||||0.318|TWO_SIDED|95.0|-9.83|30.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||30.78|-9.83|0.318
91602679|NCT01162421|183097744|SUPERIORITY_OR_OTHER||Difference in percentage|22.7||||0.047|TWO_SIDED|95.0|1.03|44.39|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||44.39|1.03|0.047
91602680|NCT01162421|183097744|SUPERIORITY_OR_OTHER||Difference in percentage|5.0||||0.668|TWO_SIDED|95.0|-17.74|27.71|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||27.71|-17.74|0.668
91602681|NCT01162421|183097744|SUPERIORITY_OR_OTHER||Difference in percentage|7.8||||0.5|TWO_SIDED|95.0|-14.88|30.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.56|-14.88|0.500
91602682|NCT01162421|183097744|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
91787172|NCT00913458|183453851|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
91602683|NCT01162421|183097744|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
91523038|NCT02798211|182921428|SUPERIORITY||Odds Ratio (OR)|6.38||||0.0001|TWO_SIDED|95.0|2.51|16.24|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit - in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.24|2.51|0.0001
91602684|NCT01162421|183097745|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||28.00|-12.17|0.444
91787173|NCT00913458|183453852|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
91602685|NCT01162421|183097745|SUPERIORITY_OR_OTHER||Difference in percentage|20.1||||0.076|TWO_SIDED|95.0|-1.53|41.83|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.83|-1.53|0.076
91602686|NCT01162421|183097745|SUPERIORITY_OR_OTHER||Difference in percentage|2.7||||0.816|TWO_SIDED|95.0|-20.1|25.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||25.52|-20.10|0.816
91602687|NCT01162421|183097745|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.485|TWO_SIDED|95.0|-14.61|30.87|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.87|-14.61|0.485
91787174|NCT00913458|183453853|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
91787175|NCT00913458|183453854|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
91787176|NCT00913458|183453855|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
91787177|NCT00913458|183453856|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||McNemar|||"P-value is from McNemar's test for no change from baseline in response rate.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
91787178|NCT00913458|183453857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.4075|TWO_SIDED|95.0|0.4|7.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.6|0.4|0.4075
91787179|NCT00913458|183453857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.88||||0.0011|TWO_SIDED|95.0|2.4|33.1|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||33.1|2.4|0.0011
91787180|NCT00913458|183453857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.0031|TWO_SIDED|95.0|1.7|13.9|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||13.9|1.7|0.0031
91787181|NCT00913458|183453858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.5951|TWO_SIDED|95.0|0.3|2.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|0.3|0.5951
91787182|NCT00913458|183453858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0934|TWO_SIDED|95.0|0.9|5.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.5|0.9|0.0934
91787183|NCT00913458|183453858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85||||0.0314|TWO_SIDED|95.0|1.1|7.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.4|1.1|0.0314
91787184|NCT00913458|183453859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6152|TWO_SIDED|95.0|0.5|2.8|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.8|0.5|0.6152
91787185|NCT00913458|183453859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0432|TWO_SIDED|95.0|1.0|5.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.4|1.0|0.0432
91787186|NCT00913458|183453859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1189|TWO_SIDED|95.0|0.8|4.3|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.3|0.8|0.1189
91787187|NCT00913458|183453860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0535|TWO_SIDED|95.0|1.0|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|1.0|0.0535
91787188|NCT00913458|183453860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0064|TWO_SIDED|95.0|1.4|7.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.5|1.4|0.0064
91787189|NCT00913458|183453860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.3696|TWO_SIDED|95.0|0.6|3.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.6|0.6|0.3696
91709495|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9217|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.34|-0.31|0.9217
91709496|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.4783|TWO_SIDED|95.0|-0.25|0.53|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.53|-0.25|0.4783
91787190|NCT00913458|183453861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0788|TWO_SIDED|95.0|0.9|5.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.2|0.9|0.0788
91709497|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.7725|TWO_SIDED|95.0|-0.32|0.43|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.43|-0.32|0.7725
91709498|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7861|TWO_SIDED|95.0|-0.43|0.33|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.33|-0.43|0.7861
91602688|NCT01162421|183097745|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
91602689|NCT01162421|183097745|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
91602690|NCT01162421|183097746|SUPERIORITY_OR_OTHER||Difference in percentage|11.6||||0.316|TWO_SIDED|95.0|-10.84|33.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.99|-10.84|0.316
91602691|NCT01162421|183097746|SUPERIORITY_OR_OTHER||Difference in percentage|5.1||||0.63|TWO_SIDED|95.0|-15.43|25.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||25.54|-15.43|0.630
91602692|NCT01162421|183097746|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.972|TWO_SIDED|95.0|-20.94|20.21|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||20.21|-20.94|0.972
91709499|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3521|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.68|-0.24|0.3521
91602693|NCT01162421|183097746|SUPERIORITY_OR_OTHER||Difference in percentage|-14.1||||0.186|TWO_SIDED|95.0|-34.83|6.7|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||6.70|-34.83|0.186
91602694|NCT01162421|183097746|SUPERIORITY_OR_OTHER||Difference in percentage|-12.6||||0.142|TWO_SIDED|95.0|-29.46|4.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||4.26|-29.46|0.142
91602695|NCT01162421|183097746|SUPERIORITY_OR_OTHER||Difference in percentage|-4.0||||0.727|TWO_SIDED|95.0|-20.34|11.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.52|-20.34|0.727
91602696|NCT01162421|183097747|SUPERIORITY_OR_OTHER||Difference in percentage|6.8||||0.486|TWO_SIDED|95.0|-9.21|22.22|||Fisher Exact|Two-sided Fisher Exact test.||||22.22|-9.21|0.486
91602697|NCT01162421|183097748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.13||0.809|TWO_SIDED|95.0|-0.23|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.29|-0.23|0.809
91602698|NCT01162421|183097748|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.132||0.194|TWO_SIDED|95.0|-0.44|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.09|-0.44|0.194
91602699|NCT01162421|183097748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.132||0.863|TWO_SIDED|95.0|-0.24|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.29|-0.24|0.863
91602700|NCT01162421|183097748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.129||0.452|TWO_SIDED|95.0|-0.16|0.35||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.35|-0.16|0.452
91602701|NCT01162421|183097748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141||0.738|TWO_SIDED|95.0|-0.23|0.33||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.33|-0.23|0.738
91602702|NCT01162421|183097748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.148||0.572|TWO_SIDED|95.0|-0.21|0.38||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.38|-0.21|0.572
91602703|NCT01162421|183097749|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.299|TWO_SIDED|95.0|-34.05|10.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||10.31|-34.05|0.299
91787191|NCT00913458|183453861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.0007|TWO_SIDED|95.0|1.9|11.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.0|1.9|0.0007
91602704|NCT01162421|183097749|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0||||0.796|TWO_SIDED|95.0|-25.77|19.77|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||19.77|-25.77|0.796
91602705|NCT01162421|183097749|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.54|TWO_SIDED|95.0|-15.3|29.22|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||29.22|-15.30|0.540
91602706|NCT01162421|183097749|SUPERIORITY_OR_OTHER||Difference in percentage|-9.6||||0.392|TWO_SIDED|95.0|-31.39|12.19|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||12.19|-31.39|0.392
91602707|NCT01162421|183097749|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3||||0.776|TWO_SIDED|95.0|-25.96|19.37|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||19.37|-25.96|0.776
91602708|NCT01162421|183097749|SUPERIORITY_OR_OTHER||Difference in percentage|-16.1||||0.166|TWO_SIDED|95.0|-38.64|6.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||6.40|-38.64|0.166
91787192|NCT00913458|183453861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0676|TWO_SIDED|95.0|0.9|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|0.9|0.0676
91602709|NCT01162421|183097750|SUPERIORITY_OR_OTHER||Difference in percentage|-10.9||||0.283|TWO_SIDED|95.0|-30.84|9.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||9.01|-30.84|0.283
91602710|NCT01162421|183097750|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||28.00|-12.17|0.444
91602711|NCT01162421|183097750|SUPERIORITY_OR_OTHER||Difference in percentage|1.6||||0.885|TWO_SIDED|95.0|-20.16|23.38|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||23.38|-20.16|0.885
91602712|NCT01162421|183097750|SUPERIORITY_OR_OTHER||Difference in percentage|-1.0||||0.931|TWO_SIDED|95.0|-22.54|20.64|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||20.64|-22.54|0.931
91602713|NCT01162421|183097750|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||23.03|-18.63|0.836
91602714|NCT01162421|183097750|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||23.03|-18.63|0.836
91602715|NCT01162421|183097751|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.25||0.699|TWO_SIDED|95.0|-3.6|5.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||5.4|-3.6|0.699
91787193|NCT00913458|183453862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.56||||0.0548|TWO_SIDED|95.0|1.0|59.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||59.5|1.0|0.0548
91602716|NCT01162421|183097751|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.45||0.261|TWO_SIDED|95.0|-2.1|7.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.7|-2.1|0.261
91602717|NCT01162421|183097751|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.36||0.514|TWO_SIDED|95.0|-6.2|3.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.2|-6.2|0.514
91602718|NCT01162421|183097751|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.5||0.283|TWO_SIDED|95.0|-7.7|2.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||2.3|-7.7|0.283
91602719|NCT01162421|183097751|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.75||0.461|TWO_SIDED|95.0|-7.5|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||3.4|-7.5|0.461
91602720|NCT01162421|183097751|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.703|TWO_SIDED|95.0|-6.6|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-6.6|0.703
91602721|NCT01162421|183097752|SUPERIORITY_OR_OTHER||Difference in percentage|-1.1||||1|TWO_SIDED|95.0|-17.94|15.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||15.16|-17.94|1.000
91602722|NCT01162421|183097752|SUPERIORITY_OR_OTHER||Difference in percentage|-6.4||||0.468|TWO_SIDED|95.0|-22.34|8.81|||Fisher Exact|Two-sided Fisher Exact test.||Month 6||8.81|-22.34|0.468
91602723|NCT01162421|183097752|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.142|TWO_SIDED|95.0|-27.88|3.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 9||3.16|-27.88|0.142
91602724|NCT01162421|183097752|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.712|TWO_SIDED|95.0|-11.08|19.83|||Fisher Exact|Two-sided Fisher Exact test.||Month 12||19.83|-11.08|0.712
91787194|NCT00913458|183453862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.18||||0.0166|TWO_SIDED|95.0|1.6|94.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||94.2|1.6|0.0166
91787195|NCT00913458|183453862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.3619|TWO_SIDED|95.0|0.6|4.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.5|0.6|0.3619
91787196|NCT00913458|183453863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23||||0.0017|TWO_SIDED|95.0|1.6|6.7|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.7|1.6|0.0017
91787197|NCT00913458|183453863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.05|||<|0.0001|TWO_SIDED|95.0|4.4|28.0|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||28.0|4.4|<0.0001
91602725|NCT01162421|183097752|SUPERIORITY_OR_OTHER||Difference in percentage|7.2||||0.482|TWO_SIDED|95.0|-8.92|22.89|||Fisher Exact|Two-sided Fisher Exact test.||Month 18||22.89|-8.92|0.482
91602726|NCT01162421|183097752|SUPERIORITY_OR_OTHER||Difference in percentage|-6.2||||0.418|TWO_SIDED|95.0|-21.18|7.69|||Fisher Exact|Two-sided Fisher Exact test.||Month 24||7.69|-21.18|0.418
91602727|NCT01162421|183097753|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|5.86||0.453|TWO_SIDED|95.0|-16.3|7.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.4|-16.3|0.453
91602728|NCT01162421|183097753|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|5.88||0.187|TWO_SIDED|95.0|-19.7|4.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||4.0|-19.7|0.187
91602729|NCT01162421|183097753|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|6.31||0.598|TWO_SIDED|95.0|-16.1|9.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||9.4|-16.1|0.598
91602730|NCT01162421|183097753|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|5.75||0.558|TWO_SIDED|95.0|-8.2|15.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||15.0|-8.2|0.558
91602731|NCT01162421|183097753|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|6.4||0.669|TWO_SIDED|95.0|-10.1|15.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||15.6|-10.1|0.669
91602732|NCT01162421|183097753|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|6.16||0.865|TWO_SIDED|95.0|-11.3|13.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||13.5|-11.3|0.865
91787198|NCT00913458|183453863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42||||0.0111|TWO_SIDED|95.0|1.3|8.8|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||8.8|1.3|0.0111
91787199|NCT00913458|183453864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66||||0.0328|TWO_SIDED|95.0|-16.6|-0.7|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.7|-16.6|0.0328
91787200|NCT00913458|183453864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.64|||<|0.0001|TWO_SIDED|95.0|-30.1|-13.2|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-13.2|-30.1|<0.0001
91650443|NCT01706198|183193556|OTHER||Adjusted Odds Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.45|1.91||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.|||1.91|1.45|<0.001
91602733|NCT01162421|183097754|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.058||0.809|TWO_SIDED|95.0|-0.1|0.13||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.13|-0.10|0.809
91602734|NCT01162421|183097754|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.062||0.447|TWO_SIDED|95.0|-0.08|0.17||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.17|-0.08|0.447
91787201|NCT00913458|183453864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98||||0.0035|TWO_SIDED|95.0|-21.5|-4.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-4.5|-21.5|0.0035
91787202|NCT00913458|183453865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||0.2473|TWO_SIDED|95.0|-11.8|3.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.1|-11.8|0.2473
91787203|NCT00913458|183453865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.0016|TWO_SIDED|95.0|-21.3|-5.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-5.1|-21.3|0.0016
91787204|NCT00913458|183453865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.0348|TWO_SIDED|95.0|-17.0|-0.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.6|-17.0|0.0348
91787205|NCT00913458|183453866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.51||||0.1248|TWO_SIDED|95.0|-12.6|1.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.6|-12.6|0.1248
91787206|NCT00913458|183453866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.14||||0.0004|TWO_SIDED|95.0|-21.8|-6.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.5|-21.8|0.0004
91787207|NCT00913458|183453866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.63||||0.0306|TWO_SIDED|95.0|-16.4|-0.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.8|-16.4|0.0306
91787208|NCT00913458|183453867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.4717|TWO_SIDED|95.0|0.5|4.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.6|0.5|0.4717
91787209|NCT00913458|183453867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.0551|TWO_SIDED|95.0|1.0|7.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.8|1.0|0.0551
91787210|NCT00913458|183453867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.2141|TWO_SIDED|95.0|0.7|4.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|0.7|0.2141
91787211|NCT00913458|183453869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9652|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.4|-0.5|0.9652
91787212|NCT00913458|183453869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2168|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2168
91787213|NCT00913458|183453869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.2131|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2131
91787214|NCT00913458|183453871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.9338|TWO_SIDED|95.0|-10.0|10.9|||ANCOVA||Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.|Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.9|-10.0|0.9338
91787215|NCT00913458|183453871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.713|TWO_SIDED|95.0|-16.4|11.2|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.2|-16.4|0.7130
91787216|NCT00913458|183453871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.6628|TWO_SIDED|95.0|-16.6|10.6|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.6|-16.6|0.6628
91787217|NCT00913458|183453873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.74||||0.1303|TWO_SIDED|95.0|-15.5|2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|-15.5|0.1303
91787218|NCT00913458|183453873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.59||||0.0024|TWO_SIDED|95.0|-27.1|-6.0|||Longitudinal statisitical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.0|-27.1|0.0024
91787219|NCT00913458|183453873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.85||||0.0621|TWO_SIDED|95.0|-20.2|0.5|||Longitudinal statistical model|||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.5|-20.2|0.0621
91787220|NCT00913458|183453875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01||||0.4664|TWO_SIDED|95.0|-15.0|6.9|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.9|-15.0|0.4664
91650444|NCT01706198|183193556|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.54|2.02||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.|||2.02|1.54|<0.001
91787221|NCT00913458|183453875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.57||||0.021|TWO_SIDED|95.0|-30.6|-2.6|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.6|-30.6|0.0210
91787222|NCT00913458|183453875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56||||0.0713|TWO_SIDED|95.0|-26.2|1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.1|-26.2|0.0713
91787223|NCT00913458|183453877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.0256|TWO_SIDED|95.0|-17.1|-1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-1.1|-17.1|0.0256
91787224|NCT00913458|183453877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-28.1|-11.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-11.1|-28.1|<0.0001
91602735|NCT01162421|183097754|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.062||0.579|TWO_SIDED|95.0|-0.16|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.09|-0.16|0.579
91602736|NCT01162421|183097754|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.057||0.922|TWO_SIDED|95.0|-0.11|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.12|-0.11|0.922
91602737|NCT01162421|183097754|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.064||0.894|TWO_SIDED|95.0|-0.14|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.12|-0.14|0.894
91787225|NCT00913458|183453877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.51||||0.0161|TWO_SIDED|95.0|-19.0|-2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.0|-19.0|0.0161
91787226|NCT05194579|183453884|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% confidence intervals (CIs) for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays Cmax statistical analysis.|Ratio of Geometric Mean|117.06|||||TWO_SIDED|90.0|103.07|132.93|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||132.93|103.07|
91787227|NCT05194579|183453885|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUClast statistical analysis.|Ratio of Geometric Mean|122.12|||||TWO_SIDED|90.0|107.9|138.22|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||138.22|107.90|
91650445|NCT01706198|183193557|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.82|2.4||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.40|1.82|<0.001
91650446|NCT01706198|183193557|OTHER||Adjusted Odds Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.7|2.25||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.25|1.70|<0.001
91787228|NCT05194579|183453886|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUCinf statistical analysis.|Ratio of Geometric Mean|123.75|||||TWO_SIDED|90.0|108.75|140.82|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||140.82|108.75|
91787229|NCT03890666|183453892|OTHER||Odds Ratio (OR)|1.33||||||||||||||The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.||||
91523039|NCT02798211|182921429|SUPERIORITY||Odds Ratio, log|9.86|||<|0.0001|TWO_SIDED|95.0|3.19|30.45|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||30.45|3.19|<.0001
91602738|NCT01162421|183097754|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.611|TWO_SIDED|95.0|-0.17|0.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.10|-0.17|0.611
91602739|NCT01162421|183097755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.42||0.572|TWO_SIDED|95.0|-11.3|6.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||6.3|-11.3|0.572
91602740|NCT01162421|183097755|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|5.15||0.13|TWO_SIDED|95.0|-2.4|18.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||18.2|-2.4|0.130
91602741|NCT01162421|183097755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.26||0.649|TWO_SIDED|95.0|-12.9|8.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.1|-12.9|0.649
91602742|NCT01162421|183097755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.8||0.579|TWO_SIDED|95.0|-12.3|6.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||6.9|-12.3|0.579
91602743|NCT01162421|183097755|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.03||0.826|TWO_SIDED|95.0|-11.1|8.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||8.9|-11.1|0.826
91602744|NCT01162421|183097755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.72||0.675|TWO_SIDED|95.0|-13.8|9.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.0|-13.8|0.675
91602745|NCT01162421|183097756|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.57||0.458|TWO_SIDED|95.0|-2.0|4.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||4.3|-2.0|0.458
91602746|NCT01162421|183097756|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.76||0.419|TWO_SIDED|95.0|-4.9|2.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.1|-4.9|0.419
91602747|NCT01162421|183097756|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.42||0.692|TWO_SIDED|95.0|-2.3|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.4|-2.3|0.692
91602748|NCT01162421|183097756|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.69||0.357|TWO_SIDED|95.0|-1.8|5.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||5.0|-1.8|0.357
91602749|NCT01162421|183097756|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.42|TWO_SIDED|95.0|-2.0|4.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||4.7|-2.0|0.420
91602750|NCT01162421|183097756|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.38|TWO_SIDED|95.0|-1.8|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-1.8|0.380
91602751|NCT01162421|183097757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.046|TWO_SIDED|95.0|0.0|1.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||1.1|0.0|0.046
91602752|NCT01162421|183097757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|0.3|1.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||1.3|0.3|0.003
91602753|NCT01162421|183097757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.204|TWO_SIDED|95.0|-0.2|0.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.8|-0.2|0.204
91650447|NCT01706198|183193557|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.56|2.06||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.06|1.56|<0.001
91523040|NCT02798211|182921429|SUPERIORITY||Odds Ratio (OR)|5.21||||0.0043|TWO_SIDED|95.0|1.68|16.21|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.21|1.68|0.0043
91602754|NCT01162421|183097757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.227|TWO_SIDED|95.0|-0.2|0.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.7|-0.2|0.227
91602755|NCT01162421|183097757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.86|TWO_SIDED|95.0|-0.4|0.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.5|-0.4|0.860
91602756|NCT01162421|183097757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.476|TWO_SIDED|95.0|-0.3|0.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.6|-0.3|0.476
91602757|NCT01260454|183097785|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||This is open-label, uncontrolled data; the comparison is made between each individual's baseline.||||0.03
91602758|NCT00091832|183097788|SUPERIORITY_OR_OTHER|||||||0.245|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.245
91602759|NCT00091832|183097789|SUPERIORITY_OR_OTHER|||||||0.848|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.848
91602760|NCT00091832|183097790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||||95.0|0.68|4.35|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.35|0.68|
91602761|NCT00091832|183097790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||||95.0|0.51|3.24|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.24|0.51|
91602762|NCT00091832|183097790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.34|2.29|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.29|0.34|
91602763|NCT00091832|183097790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||||95.0|0.51|3.2|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.20|0.51|
91602764|NCT00091832|183097790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||||95.0|0.7|4.34|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.34|0.70|
91602765|NCT00091832|183097791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||||95.0|0.69|4.79|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.79|0.69|
91602766|NCT00091832|183097791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||||95.0|0.25|1.76|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.76|0.25|
91602767|NCT00091832|183097791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||||95.0|0.24|1.77|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.77|0.24|
91602768|NCT00091832|183097791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||||95.0|0.22|1.58|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.58|0.22|
91602769|NCT00091832|183097791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||||95.0|0.25|1.92|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.92|0.25|
91602770|NCT00091832|183097792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.51|1.31|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.31|0.51|
91602771|NCT00091832|183097792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.64|1.65|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.65|0.64|
91602772|NCT00091832|183097792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
91602773|NCT00091832|183097792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
91602774|NCT00091832|183097792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||||95.0|0.71|1.83|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.83|0.71|
91602775|NCT00091832|183097803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||||95.0|0.159|1.856|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.856|0.159|
91602776|NCT00091832|183097803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.544||||||95.0|0.159|1.859|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.859|0.159|
91602777|NCT00091832|183097803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791||||||95.0|0.266|2.355|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.355|0.266|
91602778|NCT00091832|183097803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||||95.0|0.389|2.963|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.963|0.389|
91602779|NCT00091832|183097803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||||95.0|0.158|1.847|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.847|0.158|
91602780|NCT00091832|183097804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||||95.0|0.51|7.17|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.17|0.51|
91602781|NCT00091832|183097804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||||95.0|0.36|3.97|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.97|0.36|
91602782|NCT00091832|183097804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||||95.0|0.26|2.52|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.52|0.26|
91602783|NCT00091832|183097804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
91602784|NCT00091832|183097804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
91602785|NCT01634555|183097828|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.93|||||TWO_SIDED|90.0|0.83|1.05|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Irinotecan .||||1.05|0.83|
91602786|NCT01634555|183097828|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.95|||||TWO_SIDED|90.0|0.88|1.04|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.04|0.88|
91602787|NCT01634555|183097830|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|1.04|||||TWO_SIDED|90.0|0.97|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Irinotecan.||||1.12|0.97|
91602788|NCT01634555|183097830|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.85|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.12|0.85|
91602789|NCT01506882|183097833|SUPERIORITY_OR_OTHER||Percent|73.8|||||TWO_SIDED|95.0|60.9|84.2||||||"The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.~The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p\>0.4, if the lower confidence limit for p was greater than 0.4."||84.2|60.9|
91602790|NCT03072160|183097902|OTHER|||||||0.926||||||CD4|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.926
91602791|NCT03072160|183097902|OTHER|||||||0.445||||||CD8|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.445
91602792|NCT03072160|183097902|OTHER|||||||0.21||||||Tregs|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.210
91602793|NCT03072160|183097902|OTHER|||||||0.78||||||Natural Killer (NK) cells|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.780
91602794|NCT01046695|183097910|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Decrease in OME use in the TENS Unit during the first and second 24 hours.||||.005
91650448|NCT01706198|183193557|OTHER||Adjusted Odds Ratio|1.95|||<|0.001|TWO_SIDED|95.0|1.69|2.24||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.24|1.69|<0.001
91523041|NCT02798211|182921430|SUPERIORITY||Odds Ratio, log|14.38||||0.0107|TWO_SIDED|95.0|1.86|111.53|||Regression, Logistic|Statistical analysis (logistic regression) of PASI100 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||111.53|1.86|0.0107
91650449|NCT01706198|183193558|OTHER||Adjusted Odds Ratio|2.28|||<|0.001|TWO_SIDED|95.0|1.98|2.62||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.62|1.98|<0.001
91602795|NCT01046695|183097910|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||Decrease in OME use in the Control Arm during the first and second 24 hours.||||.11
91602796|NCT01046695|183097911|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||t-test, 2 sided|||||||.70
91602797|NCT00559273|183097913|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
91602798|NCT00559273|183097913|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
91602799|NCT00559273|183097914|NON_INFERIORITY_OR_EQUIVALENCE|MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.|Adjusted Mean Difference|-0.036|STANDARD_ERROR_OF_MEAN|0.1097|<|0.0001|TWO_SIDED|95.0|-0.252|0.18|||ANCOVA|||||0.180|-0.252|<0.0001
91602800|NCT03653390|183097929|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
91602801|NCT03653390|183097929|SUPERIORITY||Mean Difference (Net)|-1.24||||0.11|TWO_SIDED|95.0|-2.71|0.22|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Wellness Education - EnhanceWellness for Disability|||0.22|-2.71|0.11
91602802|NCT03653390|183097929|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.01|TWO_SIDED|95.0|-3.85|-0.95|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - EnhanceWellness for Disability|||-0.95|-3.85|<0.01
91602803|NCT03653390|183097929|SUPERIORITY||Mean Difference (Net)|-1.16||||0.16|TWO_SIDED|95.0|-2.64|0.32|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - Wellness Education|||0.32|-2.64|0.16
91602804|NCT03653390|183097930|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
91602805|NCT03653390|183097930|SUPERIORITY||Mean Difference (Net)|-2.18||||0.018|TWO_SIDED|95.0|-4.05|-0.3||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.30|-4.05|0.018
91602806|NCT03653390|183097930|SUPERIORITY||Mean Difference (Net)|-2.26||||0.012|TWO_SIDED|95.0|-4.12|-0.41||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.41|-4.12|0.012
91787230|NCT01105065|183453909|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared, Corrected|||There would be no change in retinal vascular dysregulation after treatment with brimonidine||||<0.0001
91787231|NCT01105065|183453910|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t-test|||A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.||||0.28
91787232|NCT03495856|183453926|OTHER|within-group paired t-test|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.37||0.05|TWO_SIDED|95.0|-1.55|0.0||The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.|t-test, 2 sided|||||0.00|-1.55|0.05
91787233|NCT03495856|183453927|OTHER|within-group paired t-test|Mean Difference (Final Values)|-3.67|STANDARD_ERROR_OF_MEAN|1.42||0.017|TWO_SIDED|95.0|-6.63|-0.71|||t-test, 2 sided|||||-0.71|-6.63|0.017
91787234|NCT03495856|183453928|OTHER|Within-group paired t-test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.7||0.938|TWO_SIDED|95.0|-1.39|1.5|||t-test, 2 sided|||||1.50|-1.39|0.938
91787235|NCT03495856|183453929|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.05||0.005|TWO_SIDED|95.0|-5.53|-1.15||The a priori threshold for statistical significance was p less than or equal to 0.05.|t-test, 2 sided|||||-1.15|-5.53|0.005
91787236|NCT03495856|183453930|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|1.38||0.124|TWO_SIDED|95.0|-5.09|0.66|||t-test, 2 sided|||||0.66|-5.09|0.124
91787237|NCT03495856|183453931|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|-7.3|-2.07|||t-test, 2 sided|||||-2.07|-7.30|0.001
91787238|NCT03495856|183453932|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.5||0.018|TWO_SIDED|95.0|-2.31|-0.24|||t-test, 2 sided|||||-0.24|-2.31|0.018
91787239|NCT03495856|183453933|OTHER|Within-group paired t-test|Mean Difference (Final Values)|2.79|STANDARD_ERROR_OF_MEAN|1.07||0.016|TWO_SIDED|95.0|0.58|5.01|||t-test, 2 sided|||||5.01|0.58|0.016
91787240|NCT03495856|183453934|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.96|STANDARD_ERROR_OF_MEAN|1.41||0.002|TWO_SIDED|95.0|-7.88|-2.03|||t-test, 2 sided|||||-2.03|-7.88|0.002
91787241|NCT03495856|183453935|OTHER|Within-group paired t-test|Mean Difference (Final Values)|13.27|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|8.47|18.07|||t-test, 2 sided|||||18.07|8.47|<0.001
91787242|NCT03495856|183453936|OTHER|Within-group paired t-test|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|1.96||0.001|TWO_SIDED|95.0|3.92|12.08|||t-test, 2 sided|||||12.08|3.92|0.001
91602807|NCT03653390|183097930|SUPERIORITY||Mean Difference (Net)|-0.08||||0.99|TWO_SIDED|95.0|-1.98|1.81||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||1.81|-1.98|0.99
91602808|NCT03653390|183097931|SUPERIORITY|||||||0.382|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.382
91602809|NCT03653390|183097932|SUPERIORITY|||||||0.29|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.29
91602810|NCT03653390|183097933|SUPERIORITY|||||||0.057|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.057
91602811|NCT03653390|183097934|SUPERIORITY|||||||0.21|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.21
91602812|NCT03653390|183097935|SUPERIORITY|||||||0.79|||||||ANOVA|The ANOVA was conducted on the change in radius of gyration from baseline to 12 months.||||||0.79
91602813|NCT03653390|183097936|SUPERIORITY|||||||0.26|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.26
91602814|NCT03653390|183097937|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change in minutes from baseline to 12 months.||||||<0.01
91602815|NCT03653390|183097937|SUPERIORITY||Mean Difference (Net)|-28.7||||0.57|TWO_SIDED|95.0|-95.7|38.4||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||38.4|-95.7|0.57
91602816|NCT03653390|183097937|SUPERIORITY||Mean Difference (Net)|66.6||||0.048|TWO_SIDED|95.0|0.56|132.6||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||132.6|0.56|0.048
91602817|NCT03653390|183097937|SUPERIORITY||Mean Difference (Net)|95.3|||<|0.01|TWO_SIDED|95.0|31.8|158.7||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||158.7|31.8|<0.01
91602818|NCT03653390|183097938|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 12 months.||||||<0.01
91602819|NCT03653390|183097938|SUPERIORITY||Mean Difference (Net)|-1.55||||0.028|TWO_SIDED|95.0|-2.97|-0.13||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.13|-2.97|0.028
91602820|NCT03653390|183097938|SUPERIORITY||Mean Difference (Net)|-2.15|||<|0.01|TWO_SIDED|95.0|-3.55|-0.75|||Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.75|-3.55|<0.01
91602821|NCT03653390|183097938|SUPERIORITY||Mean Difference (Net)|-0.6||||0.59|TWO_SIDED|95.0|-2.03|0.83||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||0.83|-2.03|0.59
91602822|NCT00109473|183097983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.02
91602823|NCT03213366|183097988|SUPERIORITY||Slope|-0.0095||||0.5783|TWO_SIDED|95.0|-0.04676|0.02776|||Mixed Models Analysis|||At 6 weeks.||0.02776|-0.04676|0.5783
91650450|NCT01706198|183193558|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.81|2.41||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.41|1.81|<0.001
91602824|NCT03213366|183097988|SUPERIORITY||Slope|-0.01692||||0.3185|TWO_SIDED|95.0|-0.05318|0.01933|||Mixed Models Analysis|||At 12 weeks.||0.01933|-0.05318|0.3185
91602825|NCT03213366|183097989|SUPERIORITY||Slope|0.03674||||0.07863|TWO_SIDED|95.0|-0.00516|0.07863|||Mixed Models Analysis|||At 6 weeks.||0.07863|-0.00516|0.07863
91650451|NCT01706198|183193558|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.53|2.02||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.02|1.53|<0.001
91650452|NCT01706198|183193558|OTHER||Adjusted Odds Ratio|1.91|||<|0.001|TWO_SIDED|95.0|1.66|2.21||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.21|1.66|<0.001
91602826|NCT03213366|183097989|SUPERIORITY||Slope|0.02594||||0.1999|TWO_SIDED|95.0|-0.01648|0.06836|||Mixed Models Analysis|||At 12 weeks.||0.06836|-0.01648|0.1999
91602827|NCT03213366|183097990|SUPERIORITY||Slope|0.000443||||0.8963|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.8963
91602828|NCT03213366|183097990|SUPERIORITY||Slope|0.004308||||0.3229|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks||||0.3229
91602829|NCT03213366|183097991|SUPERIORITY||Slope|0.008705||||0.2433|TWO_SIDED|||||This t-test was for the random effects model not for comparing the difference between the arms.|Mixed Models Analysis|||||||0.2433
91602830|NCT03213366|183097991|SUPERIORITY||Slope|0.01358||||0.0839|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0839
91602831|NCT03213366|183097992|SUPERIORITY||Slope|-0.302||||0.2114|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.2114
91602832|NCT03213366|183097992|SUPERIORITY||Slope|-0.03149||||0.2141|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.2141
91602833|NCT03213366|183097993|SUPERIORITY||Slope|0.0278||||0.0124|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0124
91602834|NCT03213366|183097993|SUPERIORITY||Slope|0.03052||||0.0022|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0022
91602835|NCT03213366|183097994|SUPERIORITY||Slope|-0.05747||||0.1021|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.1021
91602836|NCT03213366|183097994|SUPERIORITY||Slope|-0.05101||||0.133|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.133
91602837|NCT03213366|183097995|SUPERIORITY||Slope|-0.0209||||0.0818|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0818
91602838|NCT03213366|183097995|SUPERIORITY||Slope|0.03103||||0.0334|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0334
91523042|NCT02798211|182921430|SUPERIORITY||Odds Ratio (OR)|9.82||||0.0307|TWO_SIDED|95.0|1.24|77.9|||Regression, Logistic|Statistical analysis (logistic regression) of PAS100 response by in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||77.90|1.24|0.0307
91602839|NCT02532855|183097999|NON_INFERIORITY|For the primary hypothesis, sitagliptin will be considered non-inferior to dapagliflozin if the upper bound of the two-sided 95% confidence interval (CI) of the between-group difference in least squares mean change from baseline in A1C (sitagliptin minus dapagliflozin) is less than 0.3% (the non-inferiority margin). Longitudinal data analysis (LDA), Antihyperglycemic agent (AHA), Least squares means (LSM)|Difference in LSM (Sit. - Dap.)|-0.15|||||TWO_SIDED|95.0|-0.26|-0.04||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|
91602840|NCT02532855|183097999|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-0.15||||0.006|TWO_SIDED|95.0|-0.26|-0.04|||Longitudinal data analysis|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|0.006
91602841|NCT02532855|183098000|OTHER||Difference in % (Sit. - Dap.)|-2.8|||||TWO_SIDED|95.0|-10.7|5.1||||Miettinen \& Nurminen method||||5.1|-10.7|
91602842|NCT02532855|183098001|OTHER||Difference in % (Sit. - Dap.)|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||Miettinen \& Nurminen method||||3.0|-3.0|
91602843|NCT02532855|183098002|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-5.7||||0.138|TWO_SIDED|95.0|-13.3|1.8|||LDA|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||1.8|-13.3|0.138
91602844|NCT02532855|183098003|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-3.4|||||TWO_SIDED|95.0|-12.1|5.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline 2-hour PPG value as a covariate.||||5.3|-12.1|
91602845|NCT02532855|183098004|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-4.4|||||TWO_SIDED|95.0|-10.1|1.4||||The ANCOVA model included terms for treatment, background AHA, and the baseline glucagon AUC value as a covariate.||||1.4|-10.1|
91602846|NCT02532855|183098005|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|4.9|||||TWO_SIDED|95.0|-12.2|22.0||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC value as a covariate.||||22.0|-12.2|
91602847|NCT02532855|183098006|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|0.6|||||TWO_SIDED|95.0|-0.1|1.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC to glucagon AUC ratio value as a covariate.||||1.3|-0.1|
91602848|NCT02532855|183098007|OTHER|The percentage of participants was estimated using standard multiple imputation techniques from LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|Difference in % (Sit. - Dap.)|15.5|||||TWO_SIDED|95.0|7.7|23.2||||Miettinen and Nurminen (M\&N) method with multiple imputation from a LDA Model.||||23.2|7.7|
91523043|NCT02798211|182921431|SUPERIORITY||LS Mean of Treatment Difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.45|-0.65|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection, 16 weeks|"Standard Error of Treatment Difference~0.203"|-0.65|-1.45|<.0001
91602849|NCT02532855|183098008|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|3.5|||||TWO_SIDED|95.0|-1.2|8.3||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||8.3|-1.2|
91602850|NCT00666926|183098022|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|155.66|||||TWO_SIDED|90.0|109.66|220.95|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||220.95|109.66|
91602851|NCT00666926|183098023|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|315.72|||||TWO_SIDED|90.0|227.6|437.97|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||437.97|227.60|
91602852|NCT00666926|183098024|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|496.63|||||TWO_SIDED|90.0|206.24|1195.92|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||1195.92|206.24|
91602853|NCT01960855|183098044|OTHER||||||=|0.033|||||||Chi-squared|||||||= 0.033
91602854|NCT01960855|183098044|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
91602855|NCT01960855|183098044|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
91602856|NCT01960855|183098044|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
91602857|NCT01960855|183098045|OTHER||||||=|0.364|||||||Chi-squared|||||||= 0.364
91602858|NCT01960855|183098045|OTHER||||||=|0.014|||||||Chi-squared|||||||= 0.014
91602859|NCT01960855|183098045|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
91602860|NCT01960855|183098045|OTHER||||||=|0.008|||||||Chi-squared|||||||= 0.008
91602861|NCT01960855|183098046|OTHER||||||=|0.093|||||||Chi-squared|||||||= 0.093
91602862|NCT01960855|183098046|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
91602863|NCT01960855|183098046|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
91602864|NCT01960855|183098046|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
91602865|NCT01960855|183098047|OTHER||||||=|0.366|||||||Chi-squared|||||||= 0.366
91602866|NCT01960855|183098047|OTHER||||||=|0.17|||||||Chi-squared|||||||= 0.17
91602867|NCT01960855|183098047|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
91602868|NCT01960855|183098047|OTHER||||||=|0.028|||||||Chi-squared|||||||= 0.028
91602869|NCT01960855|183098048|OTHER||||||=|0.126|||||||Chi-squared|||||||= 0.126
91602870|NCT01960855|183098048|OTHER||||||=|0.072|||||||Chi-squared|||||||= 0.072
91602871|NCT01960855|183098048|OTHER||||||=|0.012|||||||Chi-squared|||||||= 0.012
91602872|NCT01960855|183098048|OTHER||||||=|0.021|||||||Chi-squared|||||||= 0.021
91602873|NCT01879410|183098049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA||Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.|||0.139|0.063|<0.001
91602874|NCT02058147|183098051|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.898|-0.665||Threshold for significance ≤0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.665|-0.898|<0.0001
91602875|NCT02058147|183098051|NON_INFERIORITY_OR_EQUIVALENCE|Predefined non-inferiority margin of 0.3%.|LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.384|-0.194|||Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.194|-0.384|
91602876|NCT02058147|183098051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.384|-0.194||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Test of superiority was also performed as a secondary endpoint according to hierarchical testing procedure. Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction, as a covariate.||-0.194|-0.384|<0.0001
91602877|NCT02058147|183098052|SUPERIORITY_OR_OTHER||Difference in percentage|40.61|||<|0.0001|TWO_SIDED|95.0|33.63|47.59||Threshold for significance ≤0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||47.59|33.63|<0.0001
91602878|NCT02058147|183098052|SUPERIORITY_OR_OTHER||Difference in percentage|36.38|||<|0.0001|TWO_SIDED|95.0|29.81|42.95||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||42.95|29.81|<0.0001
91602879|NCT02058147|183098052|SUPERIORITY_OR_OTHER||Difference in percentage|14.31|||<|0.0001|TWO_SIDED|95.0|8.37|20.25||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||20.25|8.37|<0.0001
91602880|NCT02058147|183098052|SUPERIORITY_OR_OTHER||Difference in percentage|16.35|||<|0.0001|TWO_SIDED|95.0|10.13|22.58||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||22.58|10.13|<0.0001
91602881|NCT02058147|183098053|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-2.498|-1.77||Threshold for significance ≤0.05. The hierarchical testing continued only when primary hypotheses (superiority: FRC to lixisenatide; non-inferiority: FRC to insulin glargine for HbA1c) was statistically significant.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0,≥8.0%), randomization strata of second OAD use at screening \& country as fixed effects \& baseline plasma glucose excursion value as a covariate. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order.||-1.77|-2.498|<0.0001
91709500|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.2166|TWO_SIDED|95.0|-0.62|0.14|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.14|-0.62|0.2166
91602882|NCT02058147|183098054|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.891|-0.91||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline body weight value-by-visit interaction as a covariate.||-0.91|-1.891|<0.0001
91787243|NCT00322621|183453944|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.|Mean Difference (Net)|0.35|||<|0.001||97.5|0.35|0.79||Significance level 0.025|t-test, 1 sided|||Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.||0.79|0.35|<0.001
91787244|NCT00322621|183453947|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||t-test, 2 sided|||||||0.269
91602883|NCT02058147|183098055|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|95.0|-2.246|-1.682||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline FPG value-by-visit interaction as a covariate.||-1.682|-2.246|<0.0001
91602884|NCT02058147|183098056|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-1.645|-1.158||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction as a covariate.||-1.158|-1.645|<0.0001
91602885|NCT02058147|183098056|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.892|-0.495||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction, as a covariate.||-0.495|-0.892|<0.0001
91650453|NCT01706198|183193559|OTHER||Mean Difference (Net)|1.54|||<|0.001|TWO_SIDED|95.0|1.3|1.77||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|Mixed Model Repeated Measures (MMRM)||Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.|||1.77|1.30|<0.001
91787245|NCT00322621|183453948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91787246|NCT00322621|183453949|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.160
91787247|NCT00322621|183453950|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
91787248|NCT00322621|183453951|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||t-test, 2 sided|||||||0.075
91787249|NCT00322621|183453952|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91787250|NCT00322621|183453953|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
91787251|NCT00322621|183453954|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
91650454|NCT01706198|183193559|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.25|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.|||1.76|1.25|<0.001
91650455|NCT01706198|183193559|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|95.0|1.11|1.63||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.|||1.63|1.11|<0.001
91650456|NCT01706198|183193559|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.24|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.|||1.76|1.24|<0.001
91650457|NCT01706198|183193561|OTHER||Ratio|1.03||||0.786|TWO_SIDED|95.0|0.83|1.28||GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.28|0.83|0.786
91650458|NCT01706198|183193562|OTHER||Ratio|1.02||||0.461|TWO_SIDED|95.0|0.97|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.97|0.461
91650459|NCT01706198|183193564|OTHER||Ratio|0.99||||0.822|TWO_SIDED|95.0|0.91|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.91|0.822
91787252|NCT00322621|183453955|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|||||||0.406
91650460|NCT01706198|183193565|OTHER||Ratio|1.1|||<|0.001|TWO_SIDED|95.0|1.05|1.15||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.15|1.05|<0.001
91787253|NCT00322621|183453956|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|||||||0.021
91787254|NCT00322621|183453957|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||t-test, 2 sided|||||||0.124
91787255|NCT00322621|183453958|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||t-test, 2 sided|||||||0.505
91787256|NCT00322621|183453959|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||t-test, 2 sided|||||||0.058
91787257|NCT00322621|183453960|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
91787258|NCT00322621|183453961|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
91787259|NCT00322621|183453962|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
91787260|NCT00322621|183453963|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.550
91787261|NCT00322621|183453964|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||t-test, 2 sided|||||||0.752
91787262|NCT00322621|183453965|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||t-test, 2 sided|||||||0.713
91787263|NCT00322621|183453966|SUPERIORITY_OR_OTHER|||||||0.066||95.0|||||t-test, 2 sided|||||||0.066
91787264|NCT00322621|183453967|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||t-test, 2 sided|||||||0.711
91787265|NCT00322621|183453968|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||t-test, 2 sided|||||||0.678
91787266|NCT00322621|183453969|SUPERIORITY_OR_OTHER|||||||0.216||95.0|||||t-test, 2 sided|||||||0.216
91787267|NCT00322621|183453970|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||t-test, 2 sided|||||||0.113
91787268|NCT00322621|183453973|SUPERIORITY_OR_OTHER|||||||0.368||95.0|||||t-test, 2 sided|||||||0.368
91787269|NCT00322621|183453974|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91787270|NCT00322621|183453975|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||t-test, 2 sided|||||||0.666
91787271|NCT00322621|183453976|SUPERIORITY_OR_OTHER|||||||0.138||95.0|||||t-test, 2 sided|||||||0.138
91787272|NCT00322621|183453977|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||t-test, 2 sided|||||||0.145
91787273|NCT00322621|183453978|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||t-test, 2 sided|||||||0.512
91787274|NCT00119678|183454084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||||Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.|||1.5|0.7|
91787275|NCT03567343|183454109|EQUIVALENCE|Significance set to 0.05|Mean Difference (Net)|-2.1||||0.1543|TWO_SIDED|95.0|-5.03|0.82||The threshold for statistical significance was P\< 0.05.|Paired T-test|||||0.82|-5.03|0.1543
91787276|NCT03567343|183454109|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.53||||0.1827|TWO_SIDED|95.0|-6.3|1.24|||Paired T-test|||||1.24|-6.3|0.1827
91787277|NCT03567343|183454110|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.8165|TWO_SIDED|95.0|-1.96|1.56|||Paired T-test|||||1.56|-1.96|0.8165
91787278|NCT03567343|183454110|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.58||||0.1821|TWO_SIDED|95.0|-0.77|3.94|||Paired T-test|||||3.94|-0.77|0.1821
91787279|NCT03567343|183454111|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.94||||0.0156|TWO_SIDED|95.0|4.19|37.69|||Paired T-test|||||37.69|4.19|0.0156
91787280|NCT03567343|183454111|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.08||||0.0572|TWO_SIDED|95.0|-0.64|40.8|||Paired T-test|||||40.8|-0.64|0.0572
91787281|NCT03567343|183454112|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-4.48||||0.0781|TWO_SIDED|95.0|-9.37|0.41|||Paired T-test|||||0.41|-9.37|0.0781
91787282|NCT03567343|183454112|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-3.0||||0.242|TWO_SIDED|95.0|-8.1|2.1|||Paired T-test|||||2.1|-8.1|0.242
91787283|NCT03567343|183454113|EQUIVALENCE|P\<0.05|Mean Difference (Net)|2.91||||0.0195|TWO_SIDED|95.0|0.49|5.32|||Paired T-test|||||5.32|0.49|0.0195
91787284|NCT03567343|183454113|EQUIVALENCE|P\<0.05|Mean Difference (Net)|4.66||||0.0097|TWO_SIDED|95.0|1.19|8.12|||Paired T-test|||||8.12|1.19|0.0097
91787285|NCT03567343|183454114|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.93|||<|0.0001|TWO_SIDED|95.0|0.59|1.28|||Paired T-test|||||1.28|0.59|<0.0001
91787286|NCT03567343|183454114|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.45||||0.0179|TWO_SIDED|95.0|0.08|0.81|||Paired T-test|||||0.81|0.08|0.0179
91787287|NCT03567343|183454115|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.9875|TWO_SIDED|95.0|-3.89|3.83|||Paired T-test|||||3.83|-3.89|0.9875
91787288|NCT03567343|183454115|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.9463|TWO_SIDED|95.0|-6.23|5.82|||Paired T-test|||||5.82|-6.23|0.9463
91787289|NCT03567343|183454116|EQUIVALENCE|P\<0.05|Mean Difference (Net)|28.5||||0.0037|TWO_SIDED|95.0|9.84|47.17|||Paired T-test|||||47.17|9.84|0.0037
91787290|NCT03567343|183454116|EQUIVALENCE|p\<0.05|Mean Difference (Net)|9.84||||0.4395|TWO_SIDED|95.0|-15.63|35.31|||Paired T-test|||||35.31|-15.63|0.4395
91787291|NCT03567343|183454117|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.912|TWO_SIDED|95.0|-0.59|0.53|||Paired T-test|||||0.53|-0.59|0.912
91787292|NCT03567343|183454117|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.11||||0.8207|TWO_SIDED|95.0|-1.04|0.83|||Paired T-test|||||0.83|-1.04|.8207
91787293|NCT03567343|183454118|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.89||||0.1929|TWO_SIDED|95.0|-2.26|0.47|||Paired T-test|||||0.47|-2.26|0.1929
91787294|NCT03567343|183454118|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.24||||0.8744|TWO_SIDED|95.0|-3.35|2.86|||Paired T-test|||||2.86|-3.35|0.8744
91787295|NCT03567343|183454119|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.95||||0.2048|TWO_SIDED|95.0|-2.45|0.54|||Paired T-test|||||0.54|-2.45|0.2048
91787296|NCT03567343|183454119|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.96||||0.1933|TWO_SIDED|95.0|-0.5|2.42|||Paired T-test|||||2.42|-0.5|0.1933
91787297|NCT03567343|183454120|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-1.69||||0.034|TWO_SIDED|95.0|-3.25|-0.13|||Paired T-test|||change in mean number of lapses||-0.13|-3.25|0.034
91787298|NCT03567343|183454120|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.41||||0.5242|TWO_SIDED|95.0|-0.88|1.71|||Paired T-test|||Change in number of lapses||1.71|-0.88|0.5242
91787299|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.67||||0.8106|TWO_SIDED|95.0|-4.92|6.25|||Paired T-test|||POMS-TMD||6.25|-4.92|0.8106
91787300|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|3.87||||0.1427|TWO_SIDED|95.0|-1.35|9.09|||Paired T-test|||POMS-TMD||9.09|-1.35|0.1427
91787301|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9344|TWO_SIDED|95.0|-1.11|1.21|||Paired T-test|||POMS-Tension||1.21|-1.11|0.9344
91787302|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.54||||0.0092|TWO_SIDED|95.0|0.4|2.69|||Paired T-test|||POMS-Tension||2.69|0.40|0.0092
91787303|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.29||||0.755|TWO_SIDED|95.0|-1.55|2.12|||Paired T-test|||POMS-Depression||2.12|-1.55|0.755
91787304|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.74||||0.2131|TWO_SIDED|95.0|-0.44|1.92|||Paired T-test|||POMS-Depression||1.92|-0.44|0.2131
91787305|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.19||||0.06|TWO_SIDED|95.0|-0.05|2.43|||Paired T-test|||POMS-Anger||2.43|-0.05|0.06
91787306|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.24||||0.4117|TWO_SIDED|95.0|-0.34|0.82|||Paired T-test|||POMS-Anger||0.82|-0.34|0.4117
91787307|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9548|TWO_SIDED|95.0|-1.64|1.73|||Paired T-test|||POMS-Fatigue||1.73|-1.64|0.9548
91787308|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.48||||0.4649|TWO_SIDED|95.0|-0.83|1.79|||Paired T-test|||POMS-Fatigue||1.79|-0.83|0.4649
91650461|NCT01706198|183193567|OTHER||Ratio|0.98||||0.697|TWO_SIDED|95.0|0.88|1.09||GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender \& age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.09|0.88|0.697
91650462|NCT01706198|183193568|OTHER||Hazard Ratio (HR)|0.96||||0.504|TWO_SIDED|95.0|0.86|1.07||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||A hazard ratio \<1 indicated a lower risk with FF/VI compared with Usual Care|||1.07|0.86|0.504
91650463|NCT01706198|183193569|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age \& number of salbutamol inhalers in year prior to randomization|ANCOVA||Difference of FF/VI versus Usual Care has been presented.|||-0.5|-1.1|<0.001
91650464|NCT01706198|183193570|OTHER||Hazard Ratio (HR)|1.23|||<|0.001|TWO_SIDED|95.0|1.09|1.38||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented|||1.38|1.09|<0.001
91709501|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5262|TWO_SIDED|95.0|-0.52|0.27|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.27|-0.52|0.5262
91709502|NCT04378569|183311573|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7575|TWO_SIDED|95.0|-0.39|0.54|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.54|-0.39|0.7575
91709503|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2662|TWO_SIDED|95.0|0.64|4.7|||Cochran-Mantel-Haenszel|Stratified|Stratified|Week 2||4.70|0.64|0.2662
91709504|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3798|TWO_SIDED|95.0|0.59|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.00|0.59|0.3798
91650465|NCT01706198|183193571|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.55|2.06||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI with Usual Care has been presented.|||2.06|1.55|<0.001
91650466|NCT01706198|183193572|OTHER||Adjusted Odds Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.73||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI versus Usual Care has been presented.|||1.73|1.31|<0.001
91709505|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0611|TWO_SIDED|95.0|0.9|11.17|||Cochran-Mantel-Haenszel|||Week 2||11.17|0.90|0.0611
91709506|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3129|TWO_SIDED|95.0|0.64|3.93|||Cochran-Mantel-Haenszel|||Week 4||3.93|0.64|0.3129
91709507|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9586|TWO_SIDED|95.0|0.35|2.74|||Cochran-Mantel-Haenszel|||Week 4||2.74|0.35|0.9586
91709508|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0643|TWO_SIDED|95.0|0.87|15.29|||Cochran-Mantel-Haenszel|||Week 4||15.29|0.87|0.0643
91709509|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0932|TWO_SIDED|95.0|0.84|6.88|||Cochran-Mantel-Haenszel|||Week 8||6.88|0.84|0.0932
91709510|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|1.42||||0.573|TWO_SIDED|95.0|0.44|4.59|||Cochran-Mantel-Haenszel|||Week 8||4.59|0.44|0.5730
91709511|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0389|TWO_SIDED|95.0|0.96|25.66|||Cochran-Mantel-Haenszel|||Week 8||25.66|0.96|0.0389
91709512|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2813|TWO_SIDED|95.0|0.6|5.53|||Cochran-Mantel-Haenszel|||Week 12||5.53|0.60|0.2813
91709513|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6841|TWO_SIDED|95.0|0.17|3.03|||Cochran-Mantel-Haenszel|||Week 12||3.03|0.17|0.6841
91709514|NCT04378569|183311575|SUPERIORITY||Odds Ratio (OR)|2.13||||0.3113|TWO_SIDED|95.0|0.49|9.21|||Cochran-Mantel-Haenszel|||Week 12||9.21|0.49|0.3113
91709515|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2674|TWO_SIDED|95.0|0.46|10.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||10.67|0.46|0.2674
91787309|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.26||||0.5656|TWO_SIDED|95.0|-0.65|1.18|||Paired T-test|||POMS-Confusion||1.18|-0.65|0.5656
91787310|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.33||||0.4307|TWO_SIDED|95.0|-0.5|1.15|||Paired T-test|||POMS-Confusion||1.15|-0.5|0.4307
91787311|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.17||||0.2651|TWO_SIDED|95.0|-0.92|3.25|||Paired T-test|||POMS-Vigor||3.25|-0.92|0.2651
91787312|NCT03567343|183454121|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.54||||0.5992|TWO_SIDED|95.0|-2.61|1.53|||Paired T-test|||POMS-Vigor||1.53|-2.61|0.5992
91787313|NCT03567343|183454122|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.37||||0.6869|TWO_SIDED|95.0|-1.48|2.22|||Paired T-test|||||2.22|-1.48|0.6869
91787314|NCT03567343|183454122|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.39||||0.1769|TWO_SIDED|95.0|-0.65|3.43|||Paired T-test|||||3.43|-0.65|0.1769
91787315|NCT03567343|183454123|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.51||||0.6422|TWO_SIDED|95.0|-1.69|2.72|||Paired T-test|||||2.72|-1.69|0.6422
91787316|NCT03567343|183454123|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.63||||0.4106|TWO_SIDED|95.0|-0.9|2.16|||Paired T-test|||||2.16|-0.9|0.4106
91787317|NCT03567343|183454124|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.23||||0.5672|TWO_SIDED|95.0|-1.05|0.58|||Paired T-test|||||0.58|-1.05|0.5672
91787318|NCT03567343|183454124|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.11||||0.805|TWO_SIDED|95.0|-0.77|0.99|||Paired T-test|||||0.99|-0.77|0.805
91602886|NCT02058147|183098057|SUPERIORITY_OR_OTHER||Difference in percentage|18.08|||<|0.0001|TWO_SIDED|95.0|12.15|24.01||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8%, ≥8%) and randomization strata of second OAD use at screening.||24.01|12.15|<0.0001
91602887|NCT02058147|183098058|SUPERIORITY_OR_OTHER||Difference in percentage|12.98|||<|0.0001|TWO_SIDED|95.0|7.5|18.45||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening.||18.45|7.5|< 0.0001
91602888|NCT02058147|183098059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.99||0.4857|TWO_SIDED|95.0|-2.632|1.252||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects.||1.252|-2.632|0.4857
91602889|NCT00773279|183098087|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95 % Confidence Interval (CI) for the treatment difference, PDS290 minus FlexPen, in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute)."|Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.127|0.032|||Linear mixed effect model|Linear mixed effect model with period and delivery systems as fixed effects, and subject as a random effect.||The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).||0.032|-0.127|
91602890|NCT00364182|183098118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|||<|0.0001|TWO_SIDED|95.0|-36.5|-24.5||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-24.5|-36.5|<0.0001
91602891|NCT00364182|183098118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5|||<|0.0001|TWO_SIDED|95.0|-38.5|-26.6||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-26.6|-38.5|<0.0001
91602892|NCT00364182|183098118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.2167|TWO_SIDED|95.0|-1.2|5.2||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||5.2|-1.2|0.2167
91602893|NCT00364182|183098119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.002|TWO_SIDED|95.0|0.1|0.6|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.6|0.1|0.002
91602894|NCT00364182|183098119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.021|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|0.1|0.021
91602895|NCT00364182|183098119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.004|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.9|0.2|0.004
91602896|NCT00364182|183098119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|-0.1|0.093
91650467|NCT01706198|183193573|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.4|||||TWO_SIDED|95.0|0.8|2.7|||||Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.|||2.7|0.8|
91650468|NCT01706198|183193574|OTHER||Hazard Ratio (HR)|1.45||||0.255|TWO_SIDED|95.0|0.77|2.74||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented.|||2.74|0.77|0.255
91650469|NCT00549198|183193578|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.435
91650470|NCT00549198|183193579|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.057
91787319|NCT03567343|183454125|EQUIVALENCE|P\<0.05|Median Difference (Net)|-43.09||||0.1236|TWO_SIDED|95.0|-98.43|12.26|||Paired T-test|||Change in lapse time||12.26|-98.43|.1236
91650471|NCT00549198|183193580|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.060
91787320|NCT03567343|183454125|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.01||||0.8241|TWO_SIDED|95.0|-20.13|16.11|||Paired T-test|||Change in lapse time||16.11|-20.13|.8241
91787321|NCT02744040|183454136|OTHER|||||||0.048||||||Multiple hypothesis testing was performed using Tukey's Honest Significant Difference (HSD) procedure.|Mixed Effects Models|||Total HIV DNA at the time of ART initiation in each of the three EDDI groups||||0.048
91790561|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.451|TWO_SIDED|95.0|-0.195|0.439||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.439|-0.195|0.451
91787322|NCT02744040|183454137|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
91787323|NCT02744040|183454137|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
91787324|NCT02744040|183454137|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
91787325|NCT02744040|183454137|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
91787326|NCT02744040|183454137|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
91602897|NCT00364182|183098120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.4|0.000
91602898|NCT00364182|183098120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.5|-0.2|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.2|-0.5|0.0000
91602899|NCT00364182|183098120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.002|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.5|0.002
91602900|NCT00364182|183098120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.031|TWO_SIDED|95.0|-0.5|0.0|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.0|-0.5|0.031
91602901|NCT00364182|183098124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.544|TWO_SIDED|95.0|-9.2|4.9|||ANOVA|||||4.9|-9.2|0.544
91602902|NCT00364182|183098124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.592|TWO_SIDED|95.0|-7.5|4.3|||ANOVA|||||4.3|-7.5|0.592
91787327|NCT02744040|183454137|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
91787328|NCT02744040|183454138|OTHER||||||>|0.05||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||Integrated HIV DNA at the time of ART initiation in each of the three EDDI groups||||>0.05
91787329|NCT02744040|183454139|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
91787330|NCT02744040|183454139|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
91602903|NCT00364182|183098124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.131|TWO_SIDED|95.0|-1.1|8.4|||ANOVA|||||8.4|-1.1|0.131
91602904|NCT01850615|183098154|SUPERIORITY_OR_OTHER||Treatment difference|-0.94|||||TWO_SIDED|95.0|-1.17|-0.72|||||Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (faster aspart+basal minus basal only), which was calculated using the FAS, was below 0%.|Change from baseline in HbA1c after 18 weeks of treatment was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits 16, 22 and 28 were included in the analysis. This model included treatment, region and strata as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.72|-1.17|
91602905|NCT00706628|183098160|SUPERIORITY_OR_OTHER|||||||0.0577|||||||Fisher Exact|||||||0.0577
91602906|NCT00706628|183098160|SUPERIORITY_OR_OTHER|||||||0.0863|||||||Fisher Exact|||||||0.0863
91602907|NCT00706628|183098162|SUPERIORITY_OR_OTHER||Slope|1.4823|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|1.1754|1.7892||||||||1.7892|1.1754|
91602908|NCT02921425|183098174|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
91602909|NCT02921425|183098176|OTHER|||||||0.007|||||||t-test, 2 sided|||||||.007
91650472|NCT00549198|183193581|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.186
91602910|NCT02921425|183098177|OTHER|||||||0.026|||||||t-test, 2 sided|||||||.026
91602911|NCT02921425|183098179|OTHER|||||||0.003||||||systolic blood pressure|t-test, 2 sided|||||||.003
91602912|NCT02921425|183098179|OTHER|||||||0.001|||||||t-test, 2 sided|||diastolic blood pressure||||.001
91602913|NCT02921425|183098181|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||.019
91787331|NCT02744040|183454139|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
91602914|NCT01227967|183098185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.0||0.046|TWO_SIDED|95.0|-19.8|-0.2||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-0.2|-19.8|0.046
91602915|NCT03403400|183098200|EQUIVALENCE|Comparison of variance|Test Statistics|0.893||||0.64|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between groups in mCTSIB Ha: There is a significant difference between groups in mCTSIB||||.640
91602916|NCT03403400|183098200|EQUIVALENCE|Comparison of variance|Test Statistics|0.196||||0.18|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in mCTSIB Ha: There is a significant difference between the prescribed walking group and the control group in mCTSIB||||.18
91602917|NCT03403400|183098201|EQUIVALENCE|comparison of variance|Test Statistics|0.803||||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in TUG Ha: There is a significant difference between the groups in TUG||||.67
91602918|NCT03403400|183098201|EQUIVALENCE|comparison of variance|Test Statistics|0.14||||0.71|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in TUG between the prescribed walking and control group Ha: There is a significant difference in TUG between the prescribed walking and control group||||.71
91709516|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.78||||0.285|TWO_SIDED|95.0|0.44|17.54|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||17.54|0.44|0.2850
91787332|NCT02744040|183454139|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
91602919|NCT03403400|183098202|EQUIVALENCE|Comparison of variance|Test Statistics|0.803|STANDARD_DEVIATION|1.79||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DGI Ha: There is a significant difference between the groups in DGI||||.67
91602920|NCT03403400|183098202|EQUIVALENCE|comparison of variance|Test Statistics|0.66||||0.42|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in DGI Ha: There is a significant difference between the prescribed walking group and control group in DGI||||.42
91602921|NCT03403400|183098203|EQUIVALENCE|comparison of variance|Test Statistics|4.386||||0.11|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DHI Ha: There is a significant difference between the groups in DHI||||.11
91602922|NCT03403400|183098203|EQUIVALENCE|comparison of variance|Test Statistics|4.351||||0.04|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in DHI between the prescribed walking group and the control group Ha: There is a significant difference in DHI between the prescribed walking group and the control group||||.04
91602923|NCT01107444|183098218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||||||The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.|t-test, 1 sided|||||||0.284
91602924|NCT01948830|183098242|NON_INFERIORITY_OR_EQUIVALENCE|The following hypothesis was tested at a one-sided 0.025 level. Non-inferiority with respect to BCVA: H01: μtreat and extend - μmonthly ≤ - Δ versus HA1: μtreat and extend - μmonthly \> - Δ where μtreat and extend and μmonthly are the unknown mean changes from baseline in BCVA to Month 12 in the treat and extend regimen and the monthly regimen, respectively. Δ is the non-inferiority margin and is pre-defined to be 5 letters for the justification of the margin.|||||<|0.001|||||||ANCOVA|||||||<0.001
91602925|NCT01446419|183098279|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.||||||0.019
91602926|NCT01557166|183098282|SUPERIORITY_OR_OTHER||Estimated treatment difference|-6.1||||0.015||95.0|-11.0|-1.19|||ANCOVA|ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.||Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.||-1.19|-11.0|0.015
91602927|NCT02411747|183098302|NON_INFERIORITY_OR_EQUIVALENCE|Beta: 0.8, p significant if p \> 0.005||||||0.34|||||||t-test, 2 sided|||Independent samples t-test||||0.34
91602928|NCT02149810|183098303|SUPERIORITY||Mean Difference (Net)|0.109||||0.28|TWO_SIDED|95.0|-0.09|0.31||The a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on SDNN.||The primary focus of this study was the interaction effect of treatment on heart rate variability at Weeks 0 and 12. On the assumption that this effect size is medium (Cohen's f = .25), calculations (using G\*Power) 23 indicate that a sample size of 80 yield power estimates of .99 for both the interaction and the main effect of time. The study enrolled 95 participants to account for participant attrition.||0.31|-0.09|0.28
91602929|NCT02149810|183098304|SUPERIORITY||Mean Difference (Net)|0.034||||0.89|TWO_SIDED|95.0|-0.44|0.51||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on LF HRV.||||0.51|-0.44|0.89
91602930|NCT02149810|183098305|SUPERIORITY||Mean Difference (Net)|-2.66||||0.03|TWO_SIDED|95.0|-5.05|-0.26||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.26|-5.05|0.030
91602931|NCT02149810|183098306|SUPERIORITY||Mean Difference (Net)|-2.37||||0.021|TWO_SIDED|95.0|-4.37|-0.36||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.36|-4.37|0.021
91602932|NCT02149810|183098307|SUPERIORITY||Mean Difference (Net)|11.0||||0.22|TWO_SIDED|95.0|-7.01|29.01||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||29.01|-7.01|0.22
91787333|NCT02744040|183454139|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
91602933|NCT02149810|183098308|SUPERIORITY||Mean Difference (Net)|1.91||||0.72|TWO_SIDED|95.0|-8.54|12.37||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||12.37|-8.54|0.72
91602934|NCT02149810|183098309|SUPERIORITY||Mean Difference (Net)|-0.8||||0.018|TWO_SIDED|95.0|-1.46|-0.15||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.15|-1.46|0.018
91787334|NCT02744040|183454139|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
91787335|NCT02744040|183454140|OTHER|||||||0.057||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||TILDA stimulation reservoir measure at the time of ART initiation in each of the three EDDI groups||||0.057
91602935|NCT02149810|183098310|SUPERIORITY||Mean Difference (Net)|-0.14||||0.99|TWO_SIDED|95.0|-21.94|21.66||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||21.66|-21.94|0.99
91602936|NCT02149810|183098311|SUPERIORITY||Odds Ratio (OR)|3.26||||0.049|TWO_SIDED|95.0|1.01|10.53||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of participants who responded to the intervention (≥50% decrease from baseline on the HRSD, defined a priori) at the end of intervention (week 12).||10.53|1.01|0.049
91602937|NCT02149810|183098312|SUPERIORITY||Odds Ratio (OR)|3.36||||0.04|TWO_SIDED|95.0|1.06|10.64||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of the proportion of participants who achieved remission (scores ≤7 on the HRSD, defined a priori) at the end of intervention (week 12).||10.64|1.06|0.040
91602938|NCT00428597|183098313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.000118|TWO_SIDED|95.0|0.263|0.662||Log-rank test statistic and 2-sided p-value from the unstratified log-rank test|Log Rank||Hazard ratio based on the Cox Proportional hazards model|||0.662|0.263|0.000118
91602939|NCT00428597|183098314|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|9.3|||||TWO_SIDED|95.0|4.1|17.5|||||Confidence interval (CI) using exact method based on binomial distribution.|||17.5|4.1|
91602940|NCT00428597|183098317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.409||||0.0204|TWO_SIDED|95.0|0.187|0.894||2-sided p-value from the unstratified log-rank test.|Log Rank||Hazard ratio based on the Cox Proportional hazards model.|||0.894|0.187|0.0204
91602941|NCT00428597|183098318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1543||||0.6799|TWO_SIDED|95.0|-4.3|6.6||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.6|-4.3|0.6799
91602942|NCT00428597|183098319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4404||||0.6058|TWO_SIDED|95.0|-6.9|4.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4|-6.9|0.6058
91650473|NCT00549198|183193582|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.413
91787336|NCT02744040|183454141|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.01||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.010
91787337|NCT02744040|183454141|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||<0.0001
91787338|NCT02744040|183454141|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
91787339|NCT02744040|183454141|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
91787340|NCT02744040|183454141|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.052||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.052
91787341|NCT02744040|183454141|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
91787342|NCT01185353|183454149|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori p-value significance threshold: 1-sided ≤0.10|Regression, Logistic|||||||<0.001
91602943|NCT00428597|183098320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5575||||0.3008|TWO_SIDED|95.0|-10.3|3.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||3.2|-10.3|0.3008
91602944|NCT00428597|183098321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7911||||0.323|TWO_SIDED|95.0|-2.8|8.3||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.3|-2.8|0.3230
91602945|NCT00428597|183098322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5113||||0.7113|TWO_SIDED|95.0|-6.5|9.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||9.5|-6.5|0.7113
91602946|NCT00428597|183098323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6672||||0.6487|TWO_SIDED|95.0|-8.9|5.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||5.5|-8.9|0.6487
91602947|NCT00428597|183098324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.6545|TWO_SIDED|95.0|-6.4|10.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||10.1|-6.4|0.6545
91602948|NCT00428597|183098325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0035||||0.1936|TWO_SIDED|95.0|-10.0|2.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||2|-10|0.1936
91602949|NCT00428597|183098326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3801|||<|0.0001|TWO_SIDED|95.0|14.3|28.4||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||28.4|14.3|<0.0001
91602950|NCT00428597|183098327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23||||0.1339|TWO_SIDED|95.0|-1.6|12.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||12.1|-1.6|0.1339
91650474|NCT00549198|183193583|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment\*visit, baseline GFR by CG\*visit, baseline BMI\*visit and baseline CD4\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.315
91787343|NCT01185353|183454151|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.045
91787344|NCT01185353|183454151|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.088
91787345|NCT01185353|183454151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
91787346|NCT01185353|183454151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
91787347|NCT01185353|183454153|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.003
91787348|NCT01185353|183454153|SUPERIORITY_OR_OTHER|||||||0.162|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.162
91787349|NCT01185353|183454153|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
91787350|NCT01185353|183454153|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
91787351|NCT01185353|183454155|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.017
91602951|NCT00428597|183098328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7816||||0.6138|TWO_SIDED|95.0|-5.1|8.7||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.7|-5.1|0.6138
91602952|NCT00428597|183098329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2778||||0.9367|TWO_SIDED|95.0|-6.6|7.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||7.1|-6.6|0.9367
91602953|NCT00428597|183098330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.753||||0.0372|TWO_SIDED|95.0|0.5|15.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||15|0.5|0.0372
91602954|NCT00428597|183098331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1463||||0.6939|TWO_SIDED|95.0|-4.6|6.9||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.9|-4.6|0.6939
91602955|NCT00428597|183098332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5128||||0.3711|TWO_SIDED|95.0|-11.2|4.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4.2|-11.2|0.3711
91602956|NCT05032950|183098383|OTHER||Reference/Test Ratio|368.33|||||TWO_SIDED|90.0|318.91|425.41|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||425.41|318.91|
91602957|NCT05032950|183098384|OTHER||Reference/Test Ratio|1430.02|||||TWO_SIDED|90.0|1204.54|1697.71|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1697.71|1204.54|
91602958|NCT05032950|183098385|OTHER||Test/Reference Ratio|1451.78|||||TWO_SIDED|90.0|1224.42|1721.35|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1721.35|1224.42|
91602959|NCT05032950|183098390|OTHER||Test/Reference Ratio|387.2|||||TWO_SIDED|90.0|335.25|447.21|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||447.21|335.25|
91602960|NCT05032950|183098391|OTHER||Test/Reference Ratio|1645.15|||||TWO_SIDED|90.0|1385.75|1953.11|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios||1953.11|1385.75|
91709517|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.63||||0.3086|TWO_SIDED|95.0|0.42|16.52|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||16.52|0.42|0.3086
91787352|NCT01185353|183454155|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.109
91787353|NCT01185353|183454155|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
91787354|NCT01185353|183454155|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
91787355|NCT01185353|183454159|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.480
91602961|NCT05032950|183098392|OTHER||Test/Reference Ratio|1677.25|||||TWO_SIDED|90.0|1414.59|1988.69|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1988.69|1414.59|
91602962|NCT03219164|183098429|NON_INFERIORITY|Non-inferiority of the 14-day treatment regimen was claimed if the lower bound of 1-sided 97.5% confidence limit of the treatment difference (14-day course group vs 28-day course group) was above the noninferiority margin of -20%.|Difference in percentage|-8.0|||||TWO_SIDED|95.0|-24.6|8.6|||||The difference in percentage between treatment groups, and the associated 95% CIs were constructed based on stratum-adjusted Mantel-Haenszel method using age as stratification factor.|||8.6|-24.6|
91602963|NCT03219164|183098431|OTHER||||||||||||||||||The historical pooled data from published results for the percentage of participants with successful PA eradication at 28 days post-treatment with TNS was estimated to be 77%.|||
91602964|NCT02863068|183098449|SUPERIORITY|||||||0.2967||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS for all participants between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for all participants.||||0.2967
91602965|NCT02863068|183098450|SUPERIORITY|||||||0.2818||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS)||||0.2818
91602966|NCT02863068|183098450|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms||||1.0
91602967|NCT02863068|183098451|SUPERIORITY|||||||0.3754||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS)||||0.3754
91602968|NCT02863068|183098453|SUPERIORITY|||||||0.1165||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.1165
91602969|NCT02863068|183098453|SUPERIORITY|||||||0.4583||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.4583
91602970|NCT02863068|183098454|SUPERIORITY|||||||0.068||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.068
91602971|NCT02863068|183098454|SUPERIORITY|||||||0.5||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.5
91602972|NCT02863068|183098454|SUPERIORITY|||||||1|||||||Fisher Exact|Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||||1.0
91602973|NCT02863068|183098454|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms for participants off Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants off Hydroxyurea (HU).||||1.0
91602974|NCT02863068|183098455|SUPERIORITY|||||||0.4298||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.4298
91602975|NCT02863068|183098455|SUPERIORITY|||||||0.2701||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.2701
91602976|NCT03932799|183098459|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, coronavirus disease (COVID)-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, and health care utilization during baseline period/acute phase.|Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Robust variance estimates"||0.38|0.16|<.001
91602977|NCT03932799|183098460|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|0.83||||0.43|TWO_SIDED|95.0|0.53|1.31||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||1.31|0.53|.43
91602978|NCT03932799|183098463|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|3.04||||0.002|TWO_SIDED|95.0|1.5|6.14||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||6.14|1.50|.002
91602979|NCT03932799|183098464|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey covariates: days from injury to baseline survey, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and physical therapy (PT) utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, quality of life.|Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.71|1.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.32|0.71|.84
91602980|NCT03932799|183098465|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.03||||0.88|TWO_SIDED|95.0|0.71|1.49||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.49|0.71|.88
91602981|NCT03932799|183098466|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.74||||0.15|TWO_SIDED|95.0|0.49|1.11||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.11|0.49|.15
91602982|NCT03932799|183098467|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.85||||0.38|TWO_SIDED|95.0|0.6|1.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.21|0.60|.38
91787356|NCT01185353|183454159|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.064
91787357|NCT01185353|183454159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787358|NCT01185353|183454159|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
91602983|NCT03932799|183098468|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.44||||0.12|TWO_SIDED|95.0|0.91|2.28||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Leisure or social activities outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.28|0.91|.12
91602984|NCT03932799|183098468|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.23||||0.42|TWO_SIDED|95.0|0.74|2.07||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Getting out with friends or family outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.07|0.74|.42
91602985|NCT03932799|183098468|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.98||||0.91|TWO_SIDED|95.0|0.63|1.51||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Doing household chores outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.51|0.63|.91
91602986|NCT03932799|183098468|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.19||||0.59|TWO_SIDED|95.0|0.64|2.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Using transportation outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.21|0.64|.59
91602987|NCT03932799|183098469|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.24||||0.22|TWO_SIDED|95.0|0.88|1.75||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.75|0.88|.22
91602988|NCT03932799|183098470|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.47||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||3.47|1.12|.02
91602989|NCT03932799|183098471|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.32||||0.1|TWO_SIDED|95.0|0.95|1.83||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.83|0.95|.10
91650475|NCT00549198|183193590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
91650476|NCT00549198|183193591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
91650477|NCT00549198|183193592|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.036
91602990|NCT03932799|183098473|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|-0.01||||0.53|TWO_SIDED|95.0|-0.03|0.01||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.01|-0.03|.53
91602991|NCT03932799|183098474|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.16||||0.053|TWO_SIDED|95.0|0.0|0.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.32|-0.00|.053
91602992|NCT03932799|183098475|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.22||||0.01|TWO_SIDED|95.0|0.05|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.38|0.05|.01
91602993|NCT03932799|183098476|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.42|1.35||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.35|0.42|.35
91602994|NCT01097629|183098477|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.3|||<|1e-05|TWO_SIDED|95.0|18.3|34.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.3|18.3|<0.00001
91602995|NCT01097629|183098478|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|25.1|||<|1e-05||95.0|16.0|34.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.2|16.0|<0.00001
91602996|NCT01097629|183098479|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.6|-22.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.3|-36.6|<0.00001
91613696|NCT02078713|183121555|SUPERIORITY||Odds Ratio (OR)|0.91||||0.55|TWO_SIDED|95.0|0.66|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.25|0.66|0.55
91613697|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|1.22||||0.13|TWO_SIDED|95.0|0.92|1.6||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.||1.6|0.92|0.13
91523044|NCT02798211|182921431|SUPERIORITY||LS Means of Treatment Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.24|-0.43|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 150 mg s.c. injection|"LS Mean of Treatment Difference~0.207"|-0.43|-1.24|<.0001
91523045|NCT02798211|182921432|SUPERIORITY||LS Mean of Treatment Difference|-0.21||||0.0107|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection|"Standard Error of Treatment Difference~0.081"|-0.05|-0.37|0.0107
91523046|NCT02798211|182921432|SUPERIORITY|secukinumab 150 mg s.c. injection|LS Mean Treatment Difference|-0.13||||0.1109|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by visit - in treatment period 1 (LOCF)|||"Standard Error of Treatment Difference~-0.083"|0.03|-0.30|0.1109
91523047|NCT01287611|182921459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.0001|||||||Chi-squared|||||||0.0001
91523048|NCT01287611|182921460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.001|||||||t-test, 2 sided|||||||0.001
91523049|NCT01856712|182921461|SUPERIORITY||Odds Ratio (OR)|1.71|||||TWO_SIDED|95.0|0.35|9.98||||||||9.98|0.35|
91523050|NCT04074590|182921477|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.314|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate is better than placebo: Prob (diff\>0)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.314
91523051|NCT04074590|182921477|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.037|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate \>15% over placebo: Prob (diff\>0.15)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.037
91523052|NCT01355458|182921479|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
91523053|NCT00509236|182921480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||||<0.001
91523054|NCT00509236|182921481|SUPERIORITY_OR_OTHER||Difference in % Affected|-4.8||||0.336|TWO_SIDED|95.0|-15.7|5.6||Miettinen \& Nurminen method stratified by prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent).|Miettinen & Nurminen|||||5.6|-15.7|0.336
91523055|NCT00509236|182921482|SUPERIORITY_OR_OTHER||Difference in % Affected|2.8|||||TWO_SIDED|95.0|-10.9|16.5||||||||16.5|-10.9|
91523056|NCT00509236|182921483|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-26.6|||<|0.001|TWO_SIDED|95.0|-38.0|-15.3|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-15.3|-38.0|<0.001
91523057|NCT00509236|182921483|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-31.2|||<|0.001|TWO_SIDED|95.0|-42.6|-19.9|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-19.9|-42.6|<0.001
91523058|NCT00509236|182921483|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|||||TWO_SIDED|95.0|-11.5|20.7||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||20.7|-11.5|
91602997|NCT01097629|183098480|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.7|-22.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.1|-36.7|<0.00001
91602998|NCT01097629|183098481|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.8||||3e-05|TWO_SIDED|95.0|-18.8|-6.9||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.9|-18.8|0.00003
91613698|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.99||||0.92|TWO_SIDED|95.0|0.75|1.3||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.||1.3|0.75|0.92
91523059|NCT00509236|182921484|SUPERIORITY_OR_OTHER||Difference in LS Means|0.15|||||TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||0.49|-0.18|
91787359|NCT01185353|183454159|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.116
91787360|NCT01185353|183454159|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.201
91787361|NCT01185353|183454159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787362|NCT01185353|183454159|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.002
91787363|NCT01185353|183454161|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.003
91787364|NCT01185353|183454161|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.167
91787365|NCT01185353|183454161|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787366|NCT01185353|183454161|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
91602999|NCT01097629|183098482|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.2||||3e-05|TWO_SIDED|95.0|-19.4|-7.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-7.0|-19.4|0.00003
91603000|NCT01097629|183098483|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.1||||4e-05|TWO_SIDED|95.0|-17.8|-6.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.4|-17.8|0.00004
91603001|NCT01097629|183098484|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-3.6||||0.2651|TWO_SIDED|95.0|-10.1|2.8||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||2.8|-10.1|0.26510
91603002|NCT01097629|183098485|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.4|||<|1e-05|TWO_SIDED|95.0|19.8|33.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||33.1|19.8|<0.00001
91603003|NCT01097629|183098486|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-42.0|||<|1e-05|TWO_SIDED|95.0|-48.6|-35.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-35.3|-48.6|<0.00001
91603004|NCT01097629|183098487|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.1|||<|1e-05|TWO_SIDED|95.0|-17.7|-8.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-8.4|-17.7|<0.00001
91603005|NCT01097629|183098488|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-21.7|||<|1e-05|TWO_SIDED|95.0|-28.6|-14.9|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-14.9|-28.6|<0.00001
91603006|NCT02613208|183098501|OTHER|Correlation analysis|Spearman coefficient|0.392|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering baseline CTC count||||<0.001
91603007|NCT02613208|183098501|OTHER|Correlation analysis|Spearman coefficient|0.088||||0.444|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering CTC count at cycle 2||||0.444
91650478|NCT00549198|183193593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|Correlation matrix for within-subject errors is unstructured.||||||<0.001
91709518|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|4.33||||0.1655|TWO_SIDED|95.0|0.46|40.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||40.83|0.46|0.1655
91603008|NCT02613208|183098503|OTHER|Correlation analysis|Spearman coefficient|0.373|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering baseline CTC count||||<0.001
91603009|NCT02613208|183098503|OTHER|Correlation analysis|Spearman coefficient|0.129||||0.241|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering CTC count at cycle 2||||0.241
91603010|NCT00008385|183098524|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.25||||0.294|TWO_SIDED|95.0|0.64|2.37||This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses|Log Rank||The 95% confidence interval was repeated confidence interval for the risk ratio|||2.37|0.64|0.294
91603011|NCT00008385|183098525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|TWO_SIDED||||||Log Rank|||||||0.069
91603012|NCT00008385|183098526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|TWO_SIDED||||||Log Rank|||||||0.154
91603013|NCT05148884|183098533|OTHER|||||||0.0016|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0016
91603014|NCT05148884|183098533|OTHER|||||||0.6886|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.6886
91603015|NCT05148884|183098534|OTHER|||||||0.0281|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0281
91603016|NCT05148884|183098534|OTHER|||||||0.7953|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.7953
91603017|NCT02064764|183098639|OTHER|Log-Rank Test For Comparing Treatment and Control||||||0.28|||||||Log Rank|||||||0.28
91603018|NCT02064764|183098640|OTHER|||||||0.7348|||||||Log Rank|||||||0.7348
91709519|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7154|TWO_SIDED|95.0|0.26|7.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||7.67|0.26|0.7154
91603019|NCT00600171|183098673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.208|TWO_SIDED|95.0|-0.036|0.164|||ANCOVA|||||0.164|-0.036|0.208
91603020|NCT00600171|183098673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069||||0.169|TWO_SIDED|95.0|-0.029|0.168|||ANCOVA|||||0.168|-0.029|0.169
91603021|NCT00600171|183098673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.011|TWO_SIDED|95.0|0.03|0.23|||ANCOVA|||||0.230|0.030|0.011
91603022|NCT00600171|183098673|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.121||||0.016|TWO_SIDED|95.0|0.023|0.22|||ANCOVA|||||0.220|0.023|0.016
91603023|NCT00600171|183098673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.001|TWO_SIDED|95.0|0.062|0.261|||ANCOVA|||||0.261|0.062|0.001
91603024|NCT03990870|183098705|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91603025|NCT03990870|183098708|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
91603026|NCT03990870|183098710|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91603027|NCT00110019|183098739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.863|TWO_SIDED|95.0|0.87|1.18|||Log Rank|Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.18|0.87|0.863
91709520|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.0||||0.5371|TWO_SIDED|95.0|0.27|14.64|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||14.64|0.27|0.5371
91709521|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|5.0||||0.217|TWO_SIDED|95.0|0.43|57.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||57.83|0.43|0.2170
91787367|NCT01185353|183454163|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.016
91787368|NCT01185353|183454163|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.108
91787369|NCT01185353|183454163|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
91787370|NCT01185353|183454163|SUPERIORITY_OR_OTHER|||||||0.368|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.368
91787371|NCT01185353|183454165|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.039
91787372|NCT01185353|183454165|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.458
91787373|NCT01185353|183454165|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
91787374|NCT01185353|183454165|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.029
91787375|NCT01185353|183454167|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.217
91787376|NCT01185353|183454167|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.092
91787377|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787378|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91523060|NCT02709005|182921490|SUPERIORITY||Risk Difference (RD)|-0.08||||0.42|TWO_SIDED|95.0|-0.26|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction. The statistical informational goal for the study of 90 participants eligible in the modified Intent-to-Treat (mITT) efficacy population was an ad-hoc sample size determined by logistical considerations, as there was insufficient pilot data upon which to base more formal sample size calculations.||0.08|-0.26|0.420
91603028|NCT00110019|183098740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.78|1.03||priori threshold for statistical significance: P\<0.05|Log Rank|Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.03|0.78|0.092
91603029|NCT00110019|183098741|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||priori threshold for statistical significance: P\<0.05|Fisher Exact|||||||0.427
91603030|NCT04276207|183098742|SUPERIORITY||Mean Difference (Final Values)|-0.377||||0.145|TWO_SIDED|95.0|-0.896|0.142|||Mixed Models Analysis|||||0.142|-0.896|0.1450
91603031|NCT04276207|183098743|SUPERIORITY||Mean Difference (Final Values)|-0.262||||0.001|TWO_SIDED|95.0|-0.406|-0.117|||Mixed Models Analysis|||||-0.117|-0.406|0.0010
91603032|NCT04276207|183098744|SUPERIORITY||Mean Difference (Final Values)|-12.61||||0.0173|TWO_SIDED|95.0|-22.73|-2.49|||Mixed Models Analysis|||Day 1||-2.49|-22.73|0.0173
91603033|NCT04276207|183098744|SUPERIORITY||Mean Difference (Final Values)|-5.75||||0.0243|TWO_SIDED|95.0|-10.69|0.81|||Mixed Models Analysis|||Day 2||0.81|-10.69|0.0243
91650479|NCT00549198|183193594|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|correlation matrix for within-subject errors is unstructured.||||||0.112
91709522|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.74||||0.3408|TWO_SIDED|95.0|0.41|18.22|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||18.22|0.41|0.3408
91787379|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787380|NCT01185353|183454167|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.072
91603034|NCT04276207|183098745|SUPERIORITY|||||||0.945|||||||Mixed Models Analysis|||Day 1||||0.945
91603035|NCT04276207|183098745|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||Day 2||||0.888
91603036|NCT01256177|183098746|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
91603037|NCT01256177|183098747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.001|TWO_SIDED|95.0|1.56|4.13|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||4.13|1.56|0.001
91603038|NCT01256177|183098748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.001|TWO_SIDED|95.0|1.46|3.86|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||3.86|1.46|0.001
91787381|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787382|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787383|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787384|NCT01185353|183454167|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.082
91603039|NCT01256177|183098749|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-1.47|STANDARD_ERROR_OF_MEAN|0.67||0.029|TWO_SIDED|95.0|-2.79|-0.15|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)||-0.15|-2.79|0.029
91650480|NCT00549198|183193595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit, and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
91709523|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.4||||0.327|TWO_SIDED|95.0|0.41|14.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||14.20|0.41|0.3270
91709524|NCT04378569|183311578|SUPERIORITY|||||||0.0719|||||||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||||0.0719
91787385|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787386|NCT01185353|183454167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787387|NCT01185353|183454169|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.024
91787388|NCT01185353|183454169|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.030
91603040|NCT01256177|183098749|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.43|STANDARD_ERROR_OF_MEAN|0.88||0.006|TWO_SIDED|95.0|-4.16|-0.69|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)||-0.69|-4.16|0.006
91650481|NCT00549198|183193628|SUPERIORITY_OR_OTHER|||||||0.3025||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3025
91650482|NCT00549198|183193629|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
91650483|NCT00549198|183193630|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3323
91787389|NCT01185353|183454169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787390|NCT01185353|183454169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787391|NCT01185353|183454171|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.120
91787392|NCT01185353|183454171|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.012
91787393|NCT01185353|183454171|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
91787394|NCT01185353|183454171|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
91787395|NCT01185353|183454173|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.409
91787396|NCT01185353|183454173|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.371
91787397|NCT01185353|183454173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
91787398|NCT01185353|183454173|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.007
91787399|NCT01185353|183454173|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.033
91787400|NCT01185353|183454173|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.019
91787401|NCT01185353|183454173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
91787402|NCT01185353|183454173|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.001
91787403|NCT01185353|183454175|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.015
91787404|NCT01185353|183454175|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.073
91787405|NCT01185353|183454175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787406|NCT01185353|183454175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787407|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.021
91787408|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.194
91787409|NCT01185353|183454176|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787410|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.012
91787411|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.449
91787412|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.578
91787413|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.140
91787414|NCT01185353|183454176|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.266
91787415|NCT01185353|183454177|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|A priori p-value significance threshold: 2-sided ≤0.10.||||||0.005
91787416|NCT01185353|183454177|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.135
91603041|NCT01256177|183098749|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.12|STANDARD_ERROR_OF_MEAN|0.95||0.001|TWO_SIDED|95.0|-5.0|-1.25|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)||-1.25|-5.00|0.001
91603042|NCT01256177|183098749|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.08|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|-4.12|-0.05|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)||-0.05|-4.12|0.045
91603043|NCT01256177|183098749|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
91603044|NCT01256177|183098750|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.83||0.007|TWO_SIDED|95.0|-3.88|-0.61|||Mixed Model Repeated Measures (MMRM)|Baseline HAM-D total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)||-0.61|-3.88|0.007
91603045|NCT01256177|183098751|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.84|-0.17|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for overall BP illness as covariate, trt, bipolar strata, visit, trt-visit interaction as fixed effect and centre as random.||Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)||-0.17|-0.84|0.003
91603046|NCT01256177|183098751|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.47|STANDARD_ERROR_OF_MEAN|0.17||0.007|TWO_SIDED|95.0|-0.81|-0.13|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for depression as covariate, trt, Bipolar strata, visit, trt-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)||-0.13|-0.81|0.007
91603047|NCT01256177|183098752|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.004|TWO_SIDED|95.0|1.26|3.36|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, baseline score and bipolar Strata.|Quetiapine XR/Placebo|||3.36|1.26|0.004
91603048|NCT01256177|183098753|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS item 10 score as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effect and centre as random.||Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)||-0.07|-0.38|0.005
91603049|NCT01256177|183098754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.233|TWO_SIDED|95.0|0.03|2.38|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, strata and baseline score.|Quetiapine XR/Placebo|||2.38|0.03|0.233
91603050|NCT00531960|183098765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Log Rank|||||1.59|0.70|0.8060
91603051|NCT00531960|183098767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.4063|TWO_SIDED|95.0|0.75|2.05|||Log Rank|||||2.05|0.75|0.4063
91603052|NCT00531960|183098768|SUPERIORITY_OR_OTHER||Difference in Response Rates|-17.28||||0.0444|TWO_SIDED|95.0|-34.8|0.3|||Chi-squared||The 95% CI for the difference of 2 rates was determined by using the Hauck-Anderson method.|||0.3|-34.8|0.0444
91603053|NCT00531960|183098769|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-12.2||||0.0944|TWO_SIDED|95.0|-27.3|2.8|||Chi-squared||The 95% CI for the difference in disease control was determined using the Hauck-Anderson method.|||2.8|-27.3|0.0944
91603054|NCT01014585|183098777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44||||0.0004|TWO_SIDED|95.0|0.27|0.71|||Log Rank|||||0.71|0.27|0.0004
91603055|NCT01014585|183098777|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
91603056|NCT01014585|183098777|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|45.0||||||95.0||||||||||||
91787417|NCT01185353|183454177|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
91787418|NCT01185353|183454177|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
91787419|NCT01185353|183454178|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.203
91787420|NCT01185353|183454178|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.164
91787421|NCT01185353|183454178|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.018
91787422|NCT01185353|183454178|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.097
91787423|NCT03456882|183454182|SUPERIORITY|||||||0.6346||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.6346
91787424|NCT03456882|183454182|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3585|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3585
91787425|NCT03456882|183454183|SUPERIORITY|||||||0.4388||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.4388
91603057|NCT01014585|183098778|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.0002|TWO_SIDED|95.0|0.2|0.63|||Log Rank|||||0.63|0.20|0.0002
91603058|NCT01014585|183098778|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|22.0||||||95.0||||||||||||
91603059|NCT01014585|183098779|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.4104|TWO_SIDED|95.0|0.46|1.38|||Log Rank|||||1.38|0.46|0.4104
91603060|NCT01014585|183098779|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
91603061|NCT01014585|183098779|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|30.0||||||95.0||||||||||||
91603062|NCT00508391|183098781|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.|Objective Performance Criteria|63.0|||||ONE_SIDED|95.0|54.8||||Non-inferiority comparison|||"Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as not worsened after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.~An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as not worsened after changing from optimized to simultaneous biventricular pacing."|||54.8|
91603063|NCT00508391|183098782|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.|Objective Performance Criteria|100.0|||||ONE_SIDED|95.0|97.6||||Non-inferiority comparison|||Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%|||97.6|
91603064|NCT02928952|183098801|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.153|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.153
91603065|NCT02928952|183098801|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.026|||||||Mixed Models Analysis|Adjusted for age and duration of diabetes.||||||0.026
91603066|NCT02928952|183098801|SUPERIORITY|Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.012|||||||Mixed Models Analysis|Models adjusted for age and duration of diabetes.||Within group analysis of intervention effect on Diabetes Distress (Problem Areas in Diabetes, PAID scale) over time stratified by hemoglobin A1c\<8.5% and =/\>8.5.||||0.012
91603067|NCT02928952|183098802|SUPERIORITY|The statistical analysis was applied to both groups.||||||0.604|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||.604
91603068|NCT02928952|183098803|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.911|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.911
91603069|NCT02928952|183098804|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.94|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||||||0.940
91603070|NCT02928952|183098805|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.305|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.305
91603071|NCT02928952|183098806|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.228|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||||||0.228
91603072|NCT02928952|183098807|SUPERIORITY|Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.671|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.671
91650484|NCT00549198|183193631|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
91787426|NCT03456882|183454183|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|20.2||0.9887|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.9887
91787427|NCT03456882|183454184|SUPERIORITY|||||||0.9622||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9622
91787428|NCT03456882|183454184|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|14.3||0.6533|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.6533
91603073|NCT02928952|183098808|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.571|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.571
91650485|NCT00549198|183193632|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
91650486|NCT00549198|183193633|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
91650487|NCT00549198|183193634|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
91650488|NCT00549198|183193635|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0266
91650489|NCT04229303|183193644|OTHER||Slope|0.62|||<|0.0001|TWO_SIDED|90.0|0.424|0.821|||General power constant model|||Statistics for Voriconazole AUC0-t||0.821|0.424|<0.0001
91650490|NCT04229303|183193644|OTHER||Slope|1.21||||0.0363|TWO_SIDED|90.0|1.05|1.362|||General power linear model|||Statistics for Voriconazole AUC0-t||1.362|1.050|0.0363
91650491|NCT04229303|183193644|OTHER||Geometric mean difference|13.48|||<|0.0001|TWO_SIDED|90.0|10.096|17.994|||ANOVA|||Statistics for Voriconazole AUC0-t, 40mg vs 5mg||17.994|10.096|<0.0001
91650492|NCT04229303|183193644|OTHER||Slope|1.85|||<|0.0001|TWO_SIDED|90.0|1.728|1.963|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-t||1.963|1.728|<0.0001
91650493|NCT04229303|183193644|OTHER||Slope|0.87||||0.0201|TWO_SIDED|90.0|0.789|0.96|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-t||0.960|0.789|0.0201
91709525|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8527|TWO_SIDED|95.0|0.07|8.43|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||8.43|0.07|0.8527
91650494|NCT04229303|183193644|OTHER||Geometric mean difference|6.16|||<|0.0001|TWO_SIDED|90.0|5.253|7.217|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t, 40mg vs 5mg||7.217|5.253|<0.0001
91650495|NCT04229303|183193644|OTHER||Slope|0.81|||<|0.0001|TWO_SIDED|90.0|0.661|0.958|||General power constant model|||Statistics for Voriconazole AUC0-inf||0.958|0.661|<0.0001
91787429|NCT03456882|183454185|SUPERIORITY|||||||0.9137||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9137
91787430|NCT03456882|183454185|SUPERIORITY||Mean Difference (Net)|16.7|STANDARD_ERROR_OF_MEAN|19.7||0.3985|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3985
91787431|NCT03456882|183454186|SUPERIORITY|||||||0.2543||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2543
91787432|NCT03456882|183454186|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.22||0.2209|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.2209
91650496|NCT04229303|183193644|OTHER||Slope|1.12||||0.1278|TWO_SIDED|90.0|0.99|1.245|||General power linear model|||Statistics for Voriconazole AUC0-inf||1.245|0.990|0.1278
91650497|NCT04229303|183193644|OTHER||Geometric mean difference|9.43|||<|0.0001|TWO_SIDED|90.0|6.834|13.012|||ANOVA|||Statistics for Voriconazole AUC0-inf, 40mg vs 5mg||13.012|6.834|<0.0001
91650498|NCT04229303|183193644|OTHER||Slope|1.98|||<|0.0001|TWO_SIDED|90.0|1.86|2.106|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-inf||2.106|1.860|<0.0001
91650499|NCT04229303|183193644|OTHER||Slope|0.79||||0.0082|TWO_SIDED|90.0|0.67|0.912|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-inf||0.912|0.670|0.0082
91650500|NCT04229303|183193644|OTHER||Geometric mean difference|5.86|||<|0.0001|TWO_SIDED|90.0|4.627|7.421|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf, 40mg vs 5mg||7.421|4.627|<0.0001
91650501|NCT04229303|183193645|OTHER||Slope|0.12||||0.2575|TWO_SIDED|90.0|-0.06|0.308|||General power constant model|||Statistics for Voriconazole Cmax||0.308|-0.060|0.2575
91650502|NCT04229303|183193645|OTHER||Slope|1.17||||0.0491|TWO_SIDED|90.0|1.03|1.316|||General power linear model|||Statistics for Voriconazole Cmax||1.316|1.030|0.0491
91650503|NCT04229303|183193645|OTHER||Geometric mean difference|11.17|||<|0.0001|TWO_SIDED|90.0|8.435|14.803|||ANOVA|||Statistics for Voriconazole Cmax, 40mg vs 5mg||14.803|8.435|<0.0001
91650504|NCT04229303|183193645|OTHER||Slope|1.25|||<|0.0001|TWO_SIDED|90.0|1.135|1.363|||General power constant model|||Statistics for N-oxide Voriconazole Cmax||1.363|1.135|<0.0001
91650505|NCT04229303|183193645|OTHER||Slope|0.74||||0.0003|TWO_SIDED|90.0|0.634|0.843|||General power linear model|||Statistics for N-oxide Voriconazole Cmax||0.843|0.634|0.0003
91650506|NCT04229303|183193645|OTHER||Geometric mean difference|4.97|||<|0.0001|TWO_SIDED|90.0|3.946|6.254|||ANOVA|||Statistics for N-oxide Voriconazole Cmax, 40mg vs 5mg||6.254|3.946|<0.0001
91650507|NCT04229303|183193652|OTHER||Slope|2.0||||0.0004|TWO_SIDED|90.0|1.528|2.617|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||2.617|1.528|0.0004
91650508|NCT04229303|183193652|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.612|6.187|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||6.187|3.612|<0.0001
91650509|NCT04229303|183193652|OTHER||Slope|2.81|||<|0.0001|TWO_SIDED|90.0|2.017|3.925|||ANOVA|||Statistics for Voriconazole AUC0-t day 10||3.925|2.017|<0.0001
91650510|NCT04229303|183193652|OTHER||Slope|5.28|||<|0.0001|TWO_SIDED|90.0|3.783|7.361|||ANOVA|||Statistics for Voriconazole AUC0-t Day 10||7.361|3.783|<0.0001
91709526|NCT04378569|183311578|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3545|TWO_SIDED|95.0|0.37|13.11|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||13.11|0.37|0.3545
91709527|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.0725|TWO_SIDED|95.0|-9.2|0.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.4|-9.2|0.0725
91603074|NCT02928952|183098809|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.003|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.003
91603075|NCT02928952|183098810|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.632|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.632
91603076|NCT02928952|183098811|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.219|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.219
91603077|NCT02928952|183098812|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.931|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.931
91603078|NCT02928952|183098813|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.627|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.627
91603079|NCT02928952|183098814|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.6|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.60
91603080|NCT02928952|183098815|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.461|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.461
91603081|NCT02928952|183098816|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.906|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.906
91603082|NCT02928952|183098817|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.856|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.856
91603083|NCT02928952|183098818|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.89|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.89
91603084|NCT04343651|183098925|SUPERIORITY|||||||0.818|||||||ANCOVA|||||||0.818
91650511|NCT04229303|183193652|OTHER||Slope|1.97|||<|0.0001|TWO_SIDED|90.0|1.615|2.396|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||2.396|1.615|<0.0001
91650512|NCT04229303|183193652|OTHER||Slope|5.09|||<|0.0001|TWO_SIDED|90.0|4.178|6.196|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||6.196|4.178|<0.0001
91650513|NCT04229303|183193652|OTHER||Slope|2.45||||0.0002|TWO_SIDED|90.0|1.791|3.349|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||3.349|1.791|0.0002
91650514|NCT04229303|183193652|OTHER||Slope|4.6|||<|0.0001|TWO_SIDED|90.0|3.365|6.294|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||6.294|3.365|<0.0001
91787433|NCT03456882|183454187|SUPERIORITY|||||||0.2738||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2738
91603085|NCT04343651|183098926|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.4138|TWO_SIDED|95.0|0.43|1.41|||Likelihood test-Cox Prop. hazards model|Stratification factors: Baseline NEWS Total score and Age.||||1.41|0.43|0.4138
91603086|NCT01583374|183098950|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.1||||0.4383|TWO_SIDED|95.0|-14.3|6.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel (CMH) weights|||6.2|-14.3|0.4383
91603087|NCT01583374|183098950|SUPERIORITY||Risk Difference (RD)|-1.7||||0.7427|TWO_SIDED|95.0|-12.0|8.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||8.5|-12.0|0.7427
91603088|NCT01583374|183098951|SUPERIORITY||LS Mean Difference|-0.05||||0.8032|TWO_SIDED|95.0|-0.41|0.32|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.32|-0.41|0.8032
91603089|NCT01583374|183098951|SUPERIORITY||LS Mean Difference|-0.17||||0.3624|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.19|-0.53|0.3624
91603090|NCT01583374|183098952|SUPERIORITY||LS Mean Difference|0.03||||0.8618|TWO_SIDED|95.0|-0.33|0.4|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.40|-0.33|0.8618
91650515|NCT04229303|183193652|OTHER||Slope|1.99||||0.0005|TWO_SIDED|90.0|1.524|2.602|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||2.602|1.524|0.0005
91650516|NCT04229303|183193652|OTHER||Slope|4.58|||<|0.0001|TWO_SIDED|90.0|3.505|5.984|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||5.984|3.505|<0.0001
91650517|NCT04229303|183193652|OTHER||Slope|2.65||||0.0003|TWO_SIDED|90.0|1.851|3.781|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||3.781|1.851|0.0003
91787434|NCT03456882|183454187|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.7||0.4239|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4239
91787435|NCT03456882|183454188|SUPERIORITY|||||||0.1708||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.1708
91603091|NCT01583374|183098952|SUPERIORITY||LS Mean Difference|-0.09||||0.6262|TWO_SIDED|95.0|-0.45|0.27|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.27|-0.45|0.6262
91603092|NCT01583374|183098953|SUPERIORITY||Risk Difference (RD)|2.0||||0.6958|TWO_SIDED|95.0|-8.1|12.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||12.2|-8.1|0.6958
91603093|NCT01583374|183098953|SUPERIORITY||Risk Difference (RD)|4.4||||0.4051|TWO_SIDED|95.0|-5.8|14.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||14.5|-5.8|0.4051
91603094|NCT01583374|183098954|SUPERIORITY||LS Mean Difference|0.25||||0.5126|TWO_SIDED|95.0|-0.49|0.99|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.99|-0.49|0.5126
91603095|NCT01583374|183098954|SUPERIORITY||LS Mean Difference|0.28||||0.4624|TWO_SIDED|95.0|-0.46|1.01|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.01|-0.46|0.4624
91603096|NCT01583374|183098955|SUPERIORITY||LS Mean Difference|0.29||||0.6997|TWO_SIDED|95.0|-1.18|1.76|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.76|-1.18|0.6997
91603097|NCT01583374|183098955|SUPERIORITY||LS Mean Difference|-0.04||||0.9587|TWO_SIDED|95.0|-1.5|1.42|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.42|-1.50|0.9587
91603098|NCT01583374|183098956|SUPERIORITY||LS Mean Difference|0.06||||0.3307|TWO_SIDED|95.0|-0.06|0.17|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.17|-0.06|0.3307
91603099|NCT01583374|183098956|SUPERIORITY||LS Mean Difference|0.03||||0.5938|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.14|-0.08|0.5938
91650518|NCT04229303|183193652|OTHER||Slope|5.04|||<|0.0001|TWO_SIDED|90.0|3.587|7.088|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||7.088|3.587|<0.0001
91650519|NCT04229303|183193652|OTHER||Slope|1.93|||<|0.0001|TWO_SIDED|90.0|1.569|2.384|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||2.384|1.569|<0.0001
91603100|NCT01265524|183098961|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.014|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.014
91603101|NCT01265524|183098965|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.0002|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.0002
91650520|NCT04229303|183193652|OTHER||Slope|4.56|||<|0.0001|TWO_SIDED|90.0|3.608|5.759|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||5.759|3.608|<0.0001
91790562|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790563|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.185||0.722|TWO_SIDED|95.0|-0.429|0.298||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.298|-0.429|0.722
91790564|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790565|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.181||0.42|TWO_SIDED|95.0|-0.503|0.21||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.210|-0.503|0.420
91650521|NCT04229303|183193652|OTHER||Slope|2.4||||0.0007|TWO_SIDED|90.0|1.694|3.402|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||3.402|1.694|0.0007
91790566|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790567|NCT02880956|183460069|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.498|TWO_SIDED|95.0|-0.495|0.241||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.241|-0.495|0.498
91790568|NCT02880956|183460069|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790569|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.071||0.975|TWO_SIDED|95.0|-0.138|0.142||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.142|-0.138|0.975
91790570|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790571|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.078|TWO_SIDED|95.0|-0.014|0.261||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.261|-0.014|0.078
91790572|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790573|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.072||0.514|TWO_SIDED|95.0|-0.188|0.094||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.094|-0.188|0.514
91790574|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91603102|NCT01265524|183098966|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.072|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.072
91603103|NCT04574999|183099017|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91603104|NCT04574999|183099018|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91603105|NCT04574999|183099020|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91603106|NCT04574999|183099021|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91787436|NCT03456882|183454188|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.25||0.8133|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.8133
91787437|NCT03456882|183454189|SUPERIORITY|||||||0.5239||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.5239
91787438|NCT03456882|183454189|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4401|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4401
91787439|NCT03456882|183454190|SUPERIORITY||difference between mean slopes|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5725|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction||Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.5725
91787440|NCT03456882|183454190|SUPERIORITY||difference between mean slopes|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5728|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5728
91787441|NCT03456882|183454191|SUPERIORITY|||||||0.9212||||||Significance level set to 0.05|Log Rank|||Null hypothesis: the survival curves over the on-treatment and the off-treatment follow-up period are not different between groups.||||0.9212
91787442|NCT03456882|183454192|SUPERIORITY||difference between mean slopes|0.41|STANDARD_ERROR_OF_MEAN|0.16||0.0101|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.0101
91787443|NCT03456882|183454192|SUPERIORITY||difference between mean slopes|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.5924|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5924
91787444|NCT03456882|183454193|SUPERIORITY|||||||0.9598||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 4 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 4 weeks is not different between groups||||0.9598
91787445|NCT03456882|183454193|SUPERIORITY|||||||0.939||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 12 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 12 weeks is not different between groups||||0.9390
91787446|NCT03456882|183454193|SUPERIORITY|||||||0.3442||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 24 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 24 weeks is not different between groups||||0.3442
91787447|NCT03456882|183454194|SUPERIORITY||difference between mean slopes|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1503|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 physical mobility. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1503
91790575|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.102||0.107|TWO_SIDED|95.0|-0.367|0.036||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.036|-0.367|0.107
91790576|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91787448|NCT03456882|183454194|SUPERIORITY||difference between mean slopes|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.1556|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 ADL and independence.Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1556
91787449|NCT03456882|183454194|SUPERIORITY||difference between mean slopes|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0319|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 eating and drinking. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.0319
91787450|NCT03456882|183454194|SUPERIORITY||difference between mean slopes|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.6419|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 communication. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.6419
91787451|NCT03456882|183454194|SUPERIORITY||difference between mean slopes|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.3951|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 emotional reactions. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.3951
91787452|NCT03456882|183454195|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|3.8||0.9563|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.9563
91787453|NCT03456882|183454196|SUPERIORITY||Mean Difference (Net)|28.5|STANDARD_ERROR_OF_MEAN|23.4||0.2253|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2253
91650522|NCT04229303|183193652|OTHER||Slope|4.22|||<|0.0001|TWO_SIDED|90.0|2.975|5.974|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||5.974|2.975|<0.0001
91603107|NCT00206726|183099027|SUPERIORITY_OR_OTHER||CR rate|0.0833||||0.014||90.0|0.0334|0.1673||2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate|exact binomial test|||Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval)||0.1673|0.0334|0.014
91603108|NCT02162862|183099062|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
91603109|NCT02162862|183099062|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
91603110|NCT02162862|183099062|OTHER|||||||0.102|||||||t-test, 2 sided|||||||.102
91603111|NCT02162862|183099063|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
91603112|NCT02162862|183099063|OTHER|||||||0.646|||||||t-test, 2 sided|||||||.646
91603113|NCT02162862|183099063|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
91603114|NCT03116113|183099066|SUPERIORITY||||||=|0.3181|||||||Fisher's Exact-Boschloo test|||||||=0.3181
91603115|NCT03116113|183099066|SUPERIORITY||||||=|0.5177|||||||Fisher's Exact-Boschloo test|||||||=0.5177
91603116|NCT03051633|183099141|SUPERIORITY|Event: Dichotimized self-reported first-time alcohol use in known participant history prior to data-collection, where substance use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If substance use was reported, censoring indicator indicates the risk period|Hazard Ratio (HR)|-0.42||||0.004|TWO_SIDED|95.0|-0.714|-0.126|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.||-0.126|-0.714|.004
91603117|NCT03051633|183099142|SUPERIORITY|Event: dichotimized self-reported first-time alcohol intoxication in known participant history prior to data collection, where intoxication was not reported in prior measurement occasions. Episodes: Represent the period of time between measurement occasions, thus, each episode represents the measured period of time between each assessment wave. Censoring: Indicates the risk period during which particpants experienced intoxication uptake.|Hazard Ratio, log|-0.39||||0.037|TWO_SIDED|95.0|-0.762|-0.018|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ration rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade year||-0.018|-0.762|.037
91603118|NCT03051633|183099143|SUPERIORITY|Event: Dichotimized self-reported first-time marijuana use in known participant history prior to data-collection, where marijuana use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If marijuana use was reported, censoring indicator indicates the risk period.|Hazard Ratio, log|0.17||||0.228|TWO_SIDED|95.0|-0.104|0.444|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.||0.444|-0.104|0.228
91603119|NCT00393718|183099147|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.|Least Squares Mean|-0.5|||<|0.0001||95.0|-0.7|-0.3||p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.~Hypothesis for non-inferiority:~H0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG \< 0.4,~Hypothesis for superiority:~H0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG \< 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure."||-0.30|-0.70|<0.0001
91603120|NCT00393718|183099148|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.49||||||95.0|-0.71|-0.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.27|-0.71|
91603121|NCT00393718|183099149|SUPERIORITY_OR_OTHER||Least Squares Mean|-12.9|||<|0.0001||95.0|-18.2|-7.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-7.5|-18.2|<0.0001
91650523|NCT04229303|183193653|OTHER||Slope|2.03||||0.0003|TWO_SIDED|90.0|1.562|2.65|||ANOVA|||Statistics for Voriconazole Cmax Day 1||2.650|1.562|0.0003
91603122|NCT00393718|183099150|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||||95.0|-18.6|-4.9|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.9|-18.6|
91603123|NCT00393718|183099151|SUPERIORITY_OR_OTHER||Least Squares Mean|-93.05|||<|0.0001||95.0|-119.61|-66.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-66.50|-119.61|<0.0001
91603124|NCT00393718|183099152|SUPERIORITY_OR_OTHER||Least Squares Mean|-74.51||||||95.0|-105.75|-43.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-43.27|-105.75|
91603125|NCT00393718|183099153|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.63|||<|0.0001||95.0|-25.0|-10.27||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-10.27|-25.00|<0.0001
91603126|NCT00393718|183099154|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.21||||||95.0|-26.32|-8.09|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-8.09|-26.32|
91603127|NCT00393718|183099155|SUPERIORITY_OR_OTHER||Least Squares Mean|-19.97|||<|0.0001||95.0|-27.99|-11.94||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-11.94|-27.99|<0.0001
91603128|NCT00393718|183099156|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.03||||||95.0|-21.46|-4.6|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.60|-21.46|
91603129|NCT00393718|183099157|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.91|||<|0.0001||95.0|-2.34|-1.48||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-1.48|-2.34|<0.0001
91650524|NCT04229303|183193653|OTHER||Slope|4.87|||<|0.0001|TWO_SIDED|90.0|3.74|6.345|||ANOVA|||Statistics for Voriconazole Cmax Day 1||6.345|3.740|<0.0001
91603130|NCT00393718|183099158|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.71||||||95.0|-2.25|-1.18|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.18|-2.25|
91603131|NCT00393718|183099159|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.12|0.35|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.35|0.12|
91603132|NCT00393718|183099159|SUPERIORITY_OR_OTHER||Rate ratio|0.18||||||95.0|0.09|0.36|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.36|0.09|
91603133|NCT00393718|183099159|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.11|0.34|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.34|0.11|
91603134|NCT03902080|183099177|SUPERIORITY||Least square mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.02|-0.46|||Mixed Models Analysis|||||-0.46|-1.02|<0.0001
91603135|NCT03902080|183099178|SUPERIORITY||Least Squares Means Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.211|<|0.0001|TWO_SIDED|95.0|-1.37|-0.54|||Mixed Models Analysis|||||-0.54|-1.37|<0.0001
91603136|NCT03902080|183099179|SUPERIORITY||Least Squares Means Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07|=|0.0015|TWO_SIDED|95.0|-0.36|-0.09|||Mixed Models Analysis|||||-0.09|-0.36|=0.0015
91603137|NCT03902080|183099180|SUPERIORITY||Least Squares Means Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.269|=|0.0034|TWO_SIDED|95.0|-1.33|-0.27|||Mixed Models Analysis|||||-0.27|-1.33|=0.0034
91603138|NCT03902080|183099181|SUPERIORITY||Least Squares Means Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Models Analysis|||||-0.5|-1.2|<0.0001
91603139|NCT03902080|183099182|SUPERIORITY||Least Squares Means Difference|15.07|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|9.13|21.02|||Mixed Models Analysis|||||21.02|9.13|<0.0001
91603140|NCT01279057|183099211|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|104.085|||||TWO_SIDED|90.0|87.421|124.21||||||||124.210|87.421|
91603141|NCT01279057|183099212|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91603142|NCT01279057|183099212|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
91603143|NCT01279057|183099213|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|106.635|||||TWO_SIDED|90.0|89.256|127.79||||||||127.790|89.256|
91603144|NCT01279057|183099214|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91603145|NCT01279057|183099214|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91603146|NCT01279057|183099215|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|115.877|||||TWO_SIDED|90.0|94.129|143.949||||||||143.949|94.129|
91603147|NCT01279057|183099216|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
91603148|NCT01279057|183099216|SUPERIORITY|||||||0.0441|||||||ANCOVA|||||||0.0441
91603149|NCT01279057|183099217|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|117.712|||||TWO_SIDED|90.0|95.41|146.583||||||||146.583|95.410|
91603150|NCT01279057|183099218|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
91603151|NCT01279057|183099218|SUPERIORITY|||||||0.0451|||||||ANCOVA|||||||0.0451
91603152|NCT00542620|183099227|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Median Difference (Final Values)|-0.691||||0.001||95.0|-1.049|-0.334||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated|ANCOVA|Baseline HbA1c as covariate||||-0.334|-1.049|0.001
91603153|NCT00542620|183099228|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Mean Difference (Final Values)|-0.594||||0.003||95.0|-0.97|-0.219||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.|ANCOVA|Baseline HbA1c as covariate.||||-0.219|-0.970|0.003
91603154|NCT00542620|183099229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|14.59||0.573||95.0|-38.77|22.08|||ANCOVA|With adjustment on baseline fructosamine and the change in insulin administration mode||||22.08|-38.77|0.573
91603155|NCT00542620|183099230|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|With adjustment on baseline value||||||0.063
91603156|NCT00542620|183099231|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|With adjustment on baseline value||||||0.389
91603157|NCT00542620|183099232|SUPERIORITY_OR_OTHER|||||||0.856|||||||ANCOVA|With adjustment on baseline value||||||0.856
91790577|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.099||0.425|TWO_SIDED|95.0|-0.275|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.116|-0.275|0.425
91603158|NCT00542620|183099233|SUPERIORITY_OR_OTHER|||||||0.917|||||||ANCOVA|With adjustment on baseline value||||||0.917
91603159|NCT00542620|183099234|SUPERIORITY_OR_OTHER|||||||0.209|||||||ANCOVA|With adjustment on baseline value||||||0.209
91603160|NCT00542620|183099235|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANCOVA|With adjustment on baseline value||||||0.220
91603161|NCT00542620|183099236|SUPERIORITY_OR_OTHER|||||||0.234|||||||ANCOVA|With adjustment for baseline value||||||0.234
91603162|NCT00542620|183099237|SUPERIORITY_OR_OTHER|||||||0.534|||||||ANCOVA|With adjustment on baseline value||||||0.534
91603163|NCT00542620|183099238|SUPERIORITY_OR_OTHER|||||||0.722|||||||ANCOVA|With adjustment on baseline value||||||0.722
91603164|NCT00542620|183099239|SUPERIORITY_OR_OTHER|||||||0.727|||||||ANCOVA|With adjustment on baseline value||||||0.727
91790578|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790579|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.102||0.039|TWO_SIDED|95.0|-0.413|-0.011||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||-0.011|-0.413|0.039
91790580|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91603165|NCT00542620|183099240|SUPERIORITY_OR_OTHER|||||||0.411|||||||ANCOVA|With adjustment on baseline value||||||0.411
91603166|NCT00542620|183099241|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANCOVA|With adjustment on baseline value||||||0.471
91603167|NCT00542620|183099244|SUPERIORITY_OR_OTHER|||||||0.127|||||||ANCOVA|With adjustment on baseline value||||||0.127
91603168|NCT00542620|183099245|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|With adjustment on baseline value||||||0.1
91603169|NCT00542620|183099246|SUPERIORITY_OR_OTHER|||||||0.166|||||||ANCOVA|With adjustment on baseline value||||||0.166
91603170|NCT00542620|183099247|SUPERIORITY_OR_OTHER|||||||0.023|||||||ANCOVA|With adjustment on baseline value||||||0.023
91790581|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.729|TWO_SIDED|95.0|-0.302|0.212||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.212|-0.302|0.729
91790582|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790583|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.128||0.671|TWO_SIDED|95.0|-0.198|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.307|-0.198|0.671
91790584|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790585|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.876|TWO_SIDED|95.0|-0.235|0.276||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.276|-0.235|0.876
91790586|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790587|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.159||0.763|TWO_SIDED|95.0|-0.266|0.362||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.362|-0.266|0.763
91790588|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790589|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.157||0.429|TWO_SIDED|95.0|-0.434|0.185||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.185|-0.434|0.429
91790590|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790591|NCT02880956|183460070|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.162||0.701|TWO_SIDED|95.0|-0.256|0.381||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.381|-0.256|0.701
91650525|NCT04229303|183193653|OTHER||Slope|2.67|||<|0.0001|TWO_SIDED|90.0|2.081|3.429|||ANOVA|||Statistics for Voriconazole Cmax Day 10||3.429|2.081|<0.0001
91650526|NCT04229303|183193653|OTHER||Slope|5.97|||<|0.0001|TWO_SIDED|90.0|4.647|7.658|||ANOVA|||Statistics for Voriconazole Cmax Day 10||7.658|4.647|<0.0001
91650527|NCT04229303|183193653|OTHER||Slope|2.02|||<|0.0001|TWO_SIDED|90.0|1.688|2.406|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||2.406|1.688|<0.0001
91650528|NCT04229303|183193653|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.964|5.65|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||5.650|3.964|<0.0001
91650529|NCT04229303|183193653|OTHER||Slope|2.12|||<|0.0001|TWO_SIDED|90.0|1.655|2.711|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 10||2.711|1.655|<0.0001
91787454|NCT03456882|183454197|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|15.7||0.6263|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.6263
91787455|NCT03456882|183454198|SUPERIORITY||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|21.0||0.3671|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.3671
91650530|NCT04229303|183193653|OTHER||Slope|4.01|||<|0.0001|TWO_SIDED|90.0|3.135|5.135|||ANOVA|||Statistics for N-oxide Voriconazole Cmax day 10||5.135|3.135|<0.0001
91787456|NCT03456882|183454199|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.845|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.845
91603171|NCT00542620|183099248|SUPERIORITY_OR_OTHER|||||||0.439|||||||ANCOVA|With adjustment on baseline value||||||0.439
91650531|NCT04229303|183193674|OTHER||Geometric mean ratio|0.13|||||TWO_SIDED|90.0|0.107|0.146||||||Part 3 - ZP-059 20mg: Oral Voriconazole (200mg VFEND)||0.146|0.107|
91650532|NCT04229303|183193674|OTHER||Geometric mean ratio|2.1|||||TWO_SIDED|90.0|1.545|2.853||||||ZP-059 20mg: Part 3 / Part 1||2.853|1.545|
91650533|NCT04229303|183193674|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
91650534|NCT04229303|183193674|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
91650535|NCT04229303|183193675|OTHER||Geometric mean ratio|0.07|||||TWO_SIDED|90.0|0.059|0.075||||||Part 3 ZP-059 20mg: Oral Voriconazole (200mg VFEND®)||0.075|0.059|
91603172|NCT00542620|183099249|SUPERIORITY_OR_OTHER|||||||0.202|||||||ANCOVA|With adjustment on baseline value||||||0.202
91650536|NCT04229303|183193675|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.85|1.891||||||ZP-059 20mg: Part 3 / Part 1||1.891|0.850|
91650537|NCT04229303|183193675|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
91650538|NCT04229303|183193675|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
91650539|NCT01764854|183193684|SUPERIORITY|||||||0.46|||||||ANCOVA|||AZD1722 in-patient and Placebo in-patient are not included in this analysis since it was only a one week evaluation period and an effect was not expected. Also the size (n=8) of the group was too small to .perform this analysis.||||0.46
91787457|NCT03456882|183454200|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2161|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2161
91603173|NCT00542620|183099250|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|With adjustment on baseline value||||||0.665
91603174|NCT00849017|183099257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.58|||ANCOVA|||||-0.58|-1.11|<0.0001
91603175|NCT00849017|183099257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.77|||ANCOVA|||||-0.77|-1.31|<0.0001
91603176|NCT02908100|183099301|SUPERIORITY||Absolute Difference|6.4||||0.373|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.373
91603177|NCT02908100|183099301|SUPERIORITY||Absolute Difference|7.5||||0.339|TWO_SIDED|95.0|-7.3|22.4|||Cochran-Mantel-Haenszel|||||22.4|-7.3|0.339
91603178|NCT02908100|183099302|SUPERIORITY||Absolute Difference|8.7||||0.223|TWO_SIDED|95.0|-6.1|23.5|||Cochran-Mantel-Haenszel|||||23.5|-6.1|0.223
91603179|NCT02908100|183099302|SUPERIORITY||Absolute Difference|3.0||||0.737|TWO_SIDED|95.0|-11.8|17.7|||Cochran-Mantel-Haenszel|||||17.7|-11.8|0.737
91603180|NCT02908100|183099303|SUPERIORITY||Absolute Difference|4.1||||0.614|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.614
91603181|NCT02908100|183099303|SUPERIORITY||Absolute Difference|4.1||||0.607|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.607
91650540|NCT01764854|183193685|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||AZD1722 out-patient and Placebo out-patient were not included in this analysis since stool was only collected in the clinical pharmacology unit of the in-patient groups.||||<0.0001
91650541|NCT03273387|183193686|SUPERIORITY|||||||0.008||||||95% Confidence interval 1.97 - 11.3 statistical significant if p\<0.05|t-test, 2 sided|t=2.988 df=18||||||0.008
91650542|NCT03273387|183193687|SUPERIORITY|||||||0.33||||||statistical significant if p \<0.05|two-way ANOVA|DF=3||||||0.33
91787458|NCT03456882|183454201|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4962|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.4962
91603182|NCT02908100|183099304|SUPERIORITY||Absolute Difference|6.4||||0.41|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.410
91603183|NCT02908100|183099304|SUPERIORITY||Absolute Difference|6.4||||0.418|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.418
91603184|NCT02908100|183099305|SUPERIORITY||Absolute Difference|14.9||||0.378|TWO_SIDED|95.0|-14.0|43.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||43.7|-14|0.378
91603185|NCT02908100|183099305|SUPERIORITY||Absolute Difference|7.5||||0.732|TWO_SIDED|95.0|-21.7|36.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||36.7|-21.7|0.732
91603186|NCT02908100|183099305|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
91603187|NCT02908100|183099305|SUPERIORITY||Absolute Difference|8.6||||0.234|TWO_SIDED|95.0|-21.4|38.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||38.7|-21.4|0.234
91603188|NCT02908100|183099305|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
91650543|NCT03273387|183193688|SUPERIORITY|||||||0.0002||||||95% Confidence interval 15.92 to 42.53 statistical significant if p \<0.05|t-test, 2 sided|t=4.598 df=19||||||0.0002
91650544|NCT01399723|183193708|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority between amoxicillin and benzyl penicillin was defined a priori as a risk difference of treatment failure and associated upper bound of the 95% confidence interval (CI) of \<7%. A sample size of 576 would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.0|4.2|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||4.2|-5.0|
91650545|NCT01399723|183193709|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-5.0|5.8|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||5.8|-5.0|
91650546|NCT01399723|183193712|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-3.3|||||TWO_SIDED|95.0|-10.0|3.0|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||3.0|-10.0|
91787459|NCT03456882|183454202|SUPERIORITY|||||||0.8738||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 4 weeks. Null hypothesis: the number of adverse events occurred within 4 weeks is not different between groups||||0.8738
91787460|NCT03456882|183454202|SUPERIORITY|||||||0.7556||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 12 weeks. Null hypothesis: the number of adverse events occurred within 12 weeks is not different between groups||||0.7556
91787461|NCT03456882|183454202|SUPERIORITY|||||||0.6477||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 24 weeks. Null hypothesis: the number of adverse events occurred within 24 weeks is not different between groups||||0.6477
91787462|NCT03456882|183454202|SUPERIORITY|||||||0.6084||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 48 weeks. Null hypothesis: the number of adverse events occurred within 48 weeks is not different between groups||||0.6084
91603189|NCT02908100|183099305|SUPERIORITY||Absolute Difference|15.2||||0.134|TWO_SIDED|95.0|-14.1|44.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||44.4|-14.1|0.134
91603190|NCT02908100|183099305|SUPERIORITY||Absolute Difference|-7.1||||0.83|TWO_SIDED|95.0|-37.6|23.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.3|-37.6|0.830
91603191|NCT02908100|183099305|SUPERIORITY||Absolute Difference|-2.2||||0.963|TWO_SIDED|95.0|-32.1|27.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||27.8|-32.1|0.963
91603192|NCT02908100|183099306|SUPERIORITY||Absolute Difference|19.0||||0.189|TWO_SIDED|95.0|-9.4|47.5|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||47.5|-9.4|0.189
91603193|NCT02908100|183099306|SUPERIORITY||Absolute Difference|6.7||||0.909|TWO_SIDED|95.0|-21.9|35.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||35.2|-21.9|0.909
91603194|NCT02908100|183099306|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
91603195|NCT02908100|183099306|SUPERIORITY||Absolute Difference|3.3||||0.234|TWO_SIDED|95.0|-27.1|33.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||33.8|-27.1|0.234
91650547|NCT00981253|183193726|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.7|-1.5|||ANCOVA|||||-1.5|-18.7|
91650548|NCT00981253|183193727|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91650549|NCT00981253|183193728|SUPERIORITY||Cox Proportional Hazard|0.47|||||TWO_SIDED|95.0|0.24|0.91|||Log Rank|||||0.91|0.24|
91787463|NCT04303195|183454421|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.479||0.135|TWO_SIDED|95.0|-1.67|0.23||The threshold for statistical significance was p = 0.05.|ANOVA|||||0.23|-1.67|0.1350
91603196|NCT02908100|183099306|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
91603197|NCT02908100|183099306|SUPERIORITY||Absolute Difference|7.2||||0.31|TWO_SIDED|95.0|-22.0|36.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||36.3|-22|0.310
91603198|NCT02908100|183099306|SUPERIORITY||Absolute Difference|-2.1||||0.922|TWO_SIDED|95.0|-32.5|28.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||28.2|-32.5|0.922
91603199|NCT02908100|183099306|SUPERIORITY||Absolute Difference|-5.9||||0.701|TWO_SIDED|95.0|-35.4|23.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.7|-35.4|0.701
91603200|NCT02908100|183099307|SUPERIORITY||Absolute Difference|3.1||||0.692|TWO_SIDED|95.0|-10.9|17.1|||Cochran-Mantel-Haenszel|||Week 24||17.1|-10.9|0.692
91603201|NCT02908100|183099307|SUPERIORITY||Absolute Difference|1.9||||0.871|TWO_SIDED|95.0|-12.0|15.9|||Cochran-Mantel-Haenszel|||Week 24||15.9|-12|0.871
91603202|NCT02908100|183099307|SUPERIORITY||Absolute Difference|11.2||||0.105|TWO_SIDED|95.0|-2.8|25.1|||Cochran-Mantel-Haenszel|||Week 48||25.1|-2.8|0.105
91650550|NCT00981253|183193729|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.95|TWO_SIDED|95.0|-0.14|1.17|||ANCOVA|||||1.17|-0.14|.95
91787464|NCT04303195|183454421|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.493||0.0997|TWO_SIDED|95.0|-1.79|0.16||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.16|-1.79|0.0997
91603203|NCT02908100|183099307|SUPERIORITY||Absolute Difference|7.7||||0.286|TWO_SIDED|95.0|-6.1|21.6|||Cochran-Mantel-Haenszel|||Week 48||21.6|-6.1|0.286
91603204|NCT02908100|183099308|SUPERIORITY||Absolute Difference|-1.6||||0.936|TWO_SIDED|95.0|-16.8|13.6|||Cochran-Mantel-Haenszel|||Week 24||13.6|-16.8|0.936
91603205|NCT02908100|183099308|SUPERIORITY||Absolute Difference|-2.9||||0.683|TWO_SIDED|95.0|-18.2|12.4|||Cochran-Mantel-Haenszel|||Week 24||12.4|-18.2|0.683
91603206|NCT02908100|183099308|SUPERIORITY||Absolute Difference|11.7||||0.086|TWO_SIDED|95.0|-3.4|26.8|||Cochran-Mantel-Haenszel|||Week 48||26.8|-3.4|0.086
91650551|NCT00981253|183193730|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
91709528|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0183|TWO_SIDED|95.0|-10.7|-1.0|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||-1.0|-10.7|0.0183
91787465|NCT04303195|183454421|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.492||0.2195|TWO_SIDED|95.0|-1.58|0.37||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.37|-1.58|0.2195
91603207|NCT02908100|183099308|SUPERIORITY||Absolute Difference|0.9||||0.879|TWO_SIDED|95.0|-14.2|16.1|||Cochran-Mantel-Haenszel|||Week 48||16.1|-14.2|0.879
91603208|NCT02631538|183099321|OTHER||Least square (LS) mean difference|-2.86|STANDARD_ERROR_OF_MEAN|1.758|||TWO_SIDED|95.0|-6.38|0.67|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.67|-6.38|
91603209|NCT02631538|183099321|OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.382|||TWO_SIDED|95.0|-3.75|1.78|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.78|-3.75|
91603210|NCT02631538|183099321|OTHER||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.442|||TWO_SIDED|95.0|-3.52|2.26|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.26|-3.52|
91603211|NCT02631538|183099321|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.732|||TWO_SIDED|95.0|-5.34|1.6|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.60|-5.34|
91603212|NCT02631538|183099321|OTHER||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|1.422|||TWO_SIDED|95.0|-2.5|3.2|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.20|-2.50|
91650552|NCT00981253|183193731|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.99|TWO_SIDED|95.0|-0.78|1.74|||ANCOVA|||||1.74|-0.78|0.99
91787466|NCT04303195|183454422|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.498||0.7944|TWO_SIDED|95.0|-1.11|0.85||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.85|-1.11|0.7944
91603213|NCT02631538|183099321|OTHER||LS mean difference|-2.45|STANDARD_ERROR_OF_MEAN|1.607|||TWO_SIDED|95.0|-5.67|0.77|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.77|-5.67|
91650553|NCT00981253|183193732|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
91650554|NCT00981253|183193732|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.99|TWO_SIDED|95.0|-0.14|0.39|||ANCOVA|||||0.39|-0.14|0.99
91650555|NCT00752791|183193733|SUPERIORITY_OR_OTHER||Mean change from Baseline|0.1|||||TWO_SIDED|95.0|-0.24|0.44|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.44|-0.24|
91709529|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.5701|TWO_SIDED|95.0|-7.7|4.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables||Week 2||4.3|-7.7|0.5701
91709530|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.2116|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||2.3|-10.4|0.2116
91603214|NCT02631538|183099321|OTHER||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.265|||TWO_SIDED|95.0|-3.99|1.08|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.08|-3.99|
91787467|NCT04303195|183454422|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.51||0.4956|TWO_SIDED|95.0|-1.36|0.66||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.66|-1.36|0.4956
91787468|NCT04303195|183454422|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.511||0.626|TWO_SIDED|95.0|-0.76|1.26||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.26|-0.76|0.6260
91603215|NCT02631538|183099321|OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.305|||TWO_SIDED|95.0|-2.68|2.55|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.55|-2.68|
91603216|NCT02631538|183099321|OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|1.584|||TWO_SIDED|95.0|-4.17|2.18|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.18|-4.17|
91603217|NCT02631538|183099321|OTHER||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-1.2|3.97|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.97|-1.20|
91603218|NCT02631538|183099321|OTHER||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.845|||TWO_SIDED|95.0|-4.66|2.73|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.73|-4.66|
91603219|NCT02631538|183099321|OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.449|||TWO_SIDED|95.0|-2.76|3.05|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.05|-2.76|
91787469|NCT04303195|183454423|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.543||0.8866|TWO_SIDED|95.0|-1.15|1.0||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.00|-1.15|0.8866
91787470|NCT04303195|183454423|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.558||0.8699|TWO_SIDED|95.0|-1.19|1.01||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.01|-1.19|0.8699
91603220|NCT02631538|183099321|OTHER||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.498|||TWO_SIDED|95.0|-2.15|3.86|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.86|-2.15|
91603221|NCT02631538|183099321|OTHER||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.817|||TWO_SIDED|95.0|-4.76|2.53|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.53|-4.76|
91650556|NCT01127581|183193740|SUPERIORITY_OR_OTHER||Median Difference (Net)|-677.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 \& DVI assuming a median time of 1600 minutes for DVI \& 34% dropout rate based on 5% 2-sided test|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
91709531|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.1235|TWO_SIDED|95.0|-11.5|1.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||1.4|-11.5|0.1235
91787471|NCT04303195|183454423|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.556||0.7297|TWO_SIDED|95.0|-0.91|1.29||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.29|-0.91|0.7297
91787472|NCT04303195|183454424|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.409||0.9034|TWO_SIDED|95.0|-0.76|0.86||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.86|-0.76|0.9034
91787473|NCT04303195|183454424|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9742|TWO_SIDED|95.0|-0.68|0.63||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.63|-0.68|0.9742
91603222|NCT02631538|183099321|OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.476|||TWO_SIDED|95.0|-2.25|3.66|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.66|-2.25|
91603223|NCT02631538|183099321|OTHER||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-5.95|0.34|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.34|-5.95|
91650557|NCT01127581|183193741|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.|Difference in Populations|-1.1|||||TWO_SIDED|95.0|-5.79|3.59|||Chi-squared||MVI 200 - DVI|The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.||3.59|-5.79|
91603224|NCT02631538|183099321|OTHER||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.237|||TWO_SIDED|95.0|-3.39|1.56|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.56|-3.39|
91603225|NCT02631538|183099321|OTHER||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.275|||TWO_SIDED|95.0|-3.91|1.2|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.20|-3.91|
91603226|NCT02631538|183099321|OTHER||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.548|||TWO_SIDED|95.0|-4.99|1.21|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.21|-4.99|
91603227|NCT02631538|183099321|OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261|||TWO_SIDED|95.0|-2.97|2.08|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.08|-2.97|
91603228|NCT02631538|183099321|OTHER||LS mean difference|-3.99|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|95.0|-7.39|-0.58|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||-0.58|-7.39|
91603229|NCT02631538|183099321|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.336|||TWO_SIDED|95.0|-4.54|0.81|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.81|-4.54|
91650558|NCT01127581|183193742|SUPERIORITY_OR_OTHER||Median Difference (Net)|-543.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.||||<0.001
91650559|NCT01127581|183193743|SUPERIORITY_OR_OTHER||Median Difference (Net)|-390.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
91650560|NCT01127581|183193744|SUPERIORITY_OR_OTHER||Difference in Proportions|-26.0|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
91650561|NCT01127581|183193745|SUPERIORITY_OR_OTHER||Difference in Proportions|9.67|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
91603230|NCT02631538|183099321|OTHER||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|1.379|||TWO_SIDED|95.0|-4.12|1.41|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.41|-4.12|
91603231|NCT02631538|183099321|OTHER||LS mean difference|-2.12|STANDARD_ERROR_OF_MEAN|1.674|||TWO_SIDED|95.0|-5.47|1.23|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.23|-5.47|
91603232|NCT02631538|183099321|OTHER||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-2.21|3.24|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.24|-2.21|
91603233|NCT01577238|183099337|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91603234|NCT00862251|183099360|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least-square means|-14.76|||<|0.001|TWO_SIDED|95.0|-19.61|-9.91|||Longitudinal data analysis (LDA)|||||-9.91|-19.61|<0.001
91603235|NCT00862251|183099361|SUPERIORITY_OR_OTHER_LEGACY||Percent change in Least Square Means|-13.62|||<|0.001|TWO_SIDED|95.0|-20.44|-6.79|||Longitudinal data analysis (LDA)|||||-6.79|-20.44|<0.001
91603236|NCT00862251|183099362|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least squares mean|-15.73|||<|0.001|TWO_SIDED|95.0|-22.65|-8.81|||Longitudinal Data Analysis (LDA)|||||-8.81|-22.65|<0.001
91603237|NCT00862251|183099363|SUPERIORITY_OR_OTHER_LEGACY||Percent Change in Least Squares Means|-3.81||||0.06|TWO_SIDED|95.0|-7.78|0.17|||Longitudinal Data Analysis|||||0.17|-7.78|0.060
91603238|NCT00862251|183099364|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.5|6.2|||Regression, Logistic|||||6.2|2.5|<0.001
91603239|NCT00862251|183099364|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.6|||Regression, Logistic|||||2.6|1.3|<0.001
91603240|NCT00862251|183099365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.3|8.5|||Regression, Logistic|||||8.5|2.3|<0.001
91603241|NCT00862251|183099366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|1.9|6.6|||Regression, Logistic|||||6.6|1.9|<0.001
91603242|NCT00862251|183099367|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.33|||<|0.001|TWO_SIDED|95.0|-11.38|-5.28|||Longitudinal data analysis (LDA)|||||-5.28|-11.38|<0.001
91603243|NCT00862251|183099367|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.63||||0.039|TWO_SIDED|95.0|-5.13|-0.13|||Longitudinal data analysis (LDA)|||||-0.13|-5.13|0.039
91603244|NCT00862251|183099368|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.88||||0.316|TWO_SIDED|95.0|-8.53|2.77|||Longitudinal data analysis (LDA)|||||2.77|-8.53|0.316
91603245|NCT00862251|183099368|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.16||||0.356|TWO_SIDED|95.0|-6.75|2.43|||Longitudinal data analysis (LDA)|||||2.43|-6.75|0.356
91603246|NCT00862251|183099369|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.47||||0.756|TWO_SIDED|95.0|-2.5|3.45|||Longitudinal data analysis (LDA)|||||3.45|-2.50|0.756
91603247|NCT00862251|183099369|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-0.52||||0.675|TWO_SIDED|95.0|-2.96|1.92|||Longitudinal data analysis (LDA)|||||1.92|-2.96|0.675
91603248|NCT00862251|183099370|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-15.93|-7.31|||Longitudinal data analysis (LDA)|||||-7.31|-15.93|<0.001
91603249|NCT00862251|183099370|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.18||||0.078|TWO_SIDED|95.0|-6.71|0.35|||Longitudinal data analysis (LDA)|||||0.35|-6.71|0.078
91603250|NCT00862251|183099371|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-14.16|||<|0.001|TWO_SIDED|95.0|-20.23|-8.1|||Longitudinal data analysis (LDA)|||||-8.10|-20.23|<0.001
91603251|NCT00862251|183099371|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-2.56||||0.313|TWO_SIDED|95.0|-7.53|2.41|||Longitudinal data analysis (LDA)|||||2.41|-7.53|0.313
91603252|NCT00862251|183099372|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.17|||<|0.001|TWO_SIDED|95.0|-12.1|-4.23|||Longitudinal data analysis (LDA)|||||-4.23|-12.10|<0.001
91603253|NCT00862251|183099372|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.83||||0.266|TWO_SIDED|95.0|-5.05|1.4|||Longitudinal data analysis (LDA)|||||1.40|-5.05|0.266
91603254|NCT00862251|183099373|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.45|||<|0.001|TWO_SIDED|95.0|-17.16|-5.75|||Longitudinal data analysis (LDA)|||||-5.75|-17.16|<0.001
91603255|NCT00862251|183099373|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.13||||0.371|TWO_SIDED|95.0|-6.81|2.54|||Longitudinal data analysis (LDA)|||||2.54|-6.81|0.371
91650562|NCT01127581|183193746|SUPERIORITY_OR_OTHER||Difference in Proportions|26.96|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
91603256|NCT00862251|183099374|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.46|-4.56|||Longitudinal data analysis (LDA)|||||-4.56|-11.46|<0.001
91603257|NCT00862251|183099374|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.95||||0.041|TWO_SIDED|95.0|-5.78|-0.12|||Longitudinal data analysis (LDA)|||||-0.12|-5.78|0.041
91603258|NCT00862251|183099375|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.57||||0.218|TWO_SIDED|95.0|-0.93|4.06|||Longitudinal data analysis (LDA)|||||4.06|-0.93|0.218
91603259|NCT00862251|183099375|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.22||||0.832|TWO_SIDED|95.0|-2.27|1.83|||Longitudinal data analysis (LDA)|||||1.83|-2.27|0.832
91603260|NCT00862251|183099376|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.91|||<|0.001|TWO_SIDED|95.0|-13.36|-4.47|||Longitudinal data analysis (LDA)|||||-4.47|-13.36|<0.001
91603261|NCT00862251|183099376|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.52||||0.175|TWO_SIDED|95.0|-6.17|1.13|||Longitudinal data analysis (LDA)|||||1.13|-6.17|0.175
91603262|NCT00862251|183099377|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.78||||0.749|TWO_SIDED|95.0|-19.88|14.32|||Longitudinal data analysis (LDA)|||||14.32|-19.88|0.749
91603263|NCT00862251|183099377|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|4.69||||0.494|TWO_SIDED|95.0|-8.73|18.1|||Longitudinal data analysis (LDA)|||||18.10|-8.73|0.494
91603264|NCT04258579|183099395|OTHER|Estimation only.|Mean value at 6 weeks|19.13|||||TWO_SIDED|95.0|15.59|22.67||||||||22.67|15.59|
91603265|NCT04258579|183099395|OTHER|Estimation only.|Mean value at 9 weeks|16.87|||||TWO_SIDED|95.0|12.5|21.24||||||||21.24|12.50|
91603266|NCT04258579|183099395|OTHER|Estimation only.|Mean value at 12 weeks|15.0|||||TWO_SIDED|95.0|11.24|18.76||||||||18.76|11.24|
91603267|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.1|||||TWO_SIDED|95.0|19.7|24.5||||||||24.50|19.70|
91603268|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|19.9|||||TWO_SIDED|95.0|18.0|21.8||||||||21.80|18.00|
91603269|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|8.93|||||TWO_SIDED|95.0|7.68|10.18||||||||10.18|7.68|
91603270|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|26.63|||||TWO_SIDED|95.0|24.32|28.94||||||||28.94|24.32|
91603271|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 9 weeks, Domain 1|22.53|||||TWO_SIDED|95.0|19.87|25.23||||||||25.23|19.87|
91603272|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 9 weeks, Domain 2|21.0|||||TWO_SIDED|95.0|18.87|23.13||||||||23.13|18.87|
91603273|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 9 weeks, Domain 3|8.69|||||TWO_SIDED|95.0|7.39|9.99||||||||9.99|7.39|
91603274|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 9 weeks, Domain 4|27.38|||||TWO_SIDED|95.0|25.07|29.69||||||||29.69|25.07|
91603275|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 12 weeks, Domain 1|22.62|||||TWO_SIDED|95.0|20.18|25.06||||||||25.06|20.18|
91603276|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 12 weeks, Domain 2|21.58|||||TWO_SIDED|95.0|19.84|23.32||||||||23.32|19.84|
91603277|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 12 weeks, Domain 3|9.19|||||TWO_SIDED|95.0|7.92|10.46||||||||10.46|7.92|
91603278|NCT04258579|183099396|OTHER|Estimation only.|Mean value at 12 weeks, Domain 4|27.81|||||TWO_SIDED|95.0|25.53|30.09||||||||30.09|25.53|
91603279|NCT04258579|183099397|OTHER|Estimation only.|Mean value at baseline|22.45|||||TWO_SIDED|95.0|19.56|25.34||||||||25.34|19.56|
91603280|NCT04258579|183099397|OTHER|Estimation only.|Mean value at 6 weeks|20.53|||||TWO_SIDED|95.0|17.65|23.41||||||||23.41|17.65|
91603281|NCT04258579|183099398|OTHER|Estimation only.|Mean value at baseline, Domain 1|19.89|||||TWO_SIDED|95.0|17.24|22.54||||||||22.54|17.24|
91603282|NCT04258579|183099398|OTHER|Estimation only.|Mean value at baseline, Domain 2|22.46|||||TWO_SIDED|95.0|19.72|25.2||||||||25.20|19.72|
91603283|NCT04258579|183099398|OTHER|Estimation only.|Mean value at baseline, Domain 3|16.0|||||TWO_SIDED|95.0|13.72|18.28||||||||18.28|13.72|
91603284|NCT04258579|183099398|OTHER|Estimation only.|Mean value at baseline, Domain 4|17.79|||||TWO_SIDED|95.0|15.34|20.24||||||||20.24|15.34|
91603285|NCT04258579|183099398|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.79|||||TWO_SIDED|95.0|19.05|26.53||||||||26.53|19.05|
91603286|NCT04258579|183099398|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|26.7|||||TWO_SIDED|95.0|22.96|30.44||||||||30.44|22.96|
91603287|NCT04258579|183099398|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|17.45|||||TWO_SIDED|95.0|14.57|20.33||||||||20.33|14.57|
91603288|NCT04258579|183099398|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|20.69|||||TWO_SIDED|95.0|18.23|23.15||||||||23.15|18.23|
91603289|NCT00331006|183099415|SUPERIORITY_OR_OTHER||Proportion|0.1875||||0.043|ONE_SIDED|95.0|0.053|||the a priori p-value was 0.05 for statistical significance|Exact Binomial|||The null hypothesis is that the proportion of participants in which the inhibitor level falls to less than 5 BU/mL between weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with factor VIII is no more than 0.05|||.053|0.043
91603290|NCT00331006|183099416|SUPERIORITY_OR_OTHER||Proportion|0.25|||||TWO_SIDED|95.0|0.073|0.524|||Exact Binomial|||No hypothesis about the value of this proportion was specified in the study design||0.524|0.073|
91603291|NCT03183128|183099434|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value presented for both hypothesis tests: H0: RR≥1 and H0: RR≥0.833.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|||0.58|0.18|<0.001
91603292|NCT03183128|183099435|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.19|0.67||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 4||0.67|0.19|<0.001
91603293|NCT03183128|183099435|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|95.0|0.24|0.65||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 12||0.65|0.24|<0.001
91603294|NCT03183128|183099435|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.3|0.73||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 24||0.73|0.30|<0.001
91603295|NCT01225562|183099436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.008|TWO_SIDED|95.0|0.75|0.96|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||0.96|0.75|0.0080
91603296|NCT01225562|183099436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0043|TWO_SIDED|95.0|0.74|0.95|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||0.95|0.74|0.0043
91603297|NCT01225562|183099437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1547|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.06|0.71|0.1547
91603298|NCT01225562|183099437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0676|TWO_SIDED|95.0|0.68|1.01|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.01|0.68|0.0676
91603299|NCT01225562|183099438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9851|TWO_SIDED|95.0|0.86|1.16|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.16|0.86|0.9851
91603300|NCT01225562|183099438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.135|TWO_SIDED|95.0|0.76|1.04|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.04|0.76|0.1350
91603301|NCT01225562|183099439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.96|3.7|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||3.70|1.96|<0.0001
91650563|NCT01127581|183193747|SUPERIORITY_OR_OTHER||Difference in Proportions|13.9|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
91603302|NCT01225562|183099439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.68|3.21|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||3.21|1.68|<0.0001
91650564|NCT01127581|183193748|SUPERIORITY_OR_OTHER||Difference in Proportions|29.8|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
91787474|NCT04303195|183454424|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.417||0.2235|TWO_SIDED|95.0|-0.31|1.33||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.33|-0.31|0.2235
91787475|NCT04303195|183454425|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3567|TWO_SIDED|95.0|-0.34|0.12||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.12|-0.34|0.3567
91603303|NCT01375764|183099440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.94|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-44.08|-27.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-27.80|-44.08|<0.001
91603304|NCT01375764|183099440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.82|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.97|-19.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-19.67|-35.97|<0.001
91603305|NCT01375764|183099440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Tretament Difference|-26.01|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-34.08|-17.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-17.93|-34.08|<0.001
91603306|NCT01375764|183099441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.29|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-53.73|-40.84||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab + ezetimibe and ezetimibe alone, and the alternative hypothesis was that a mean difference did exist.||-40.84|-53.73|<0.001
91603307|NCT01375764|183099442|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-94.9|-58.3||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-58.3|-94.9|<0.001
91650565|NCT01127581|183193749|SUPERIORITY_OR_OTHER||Difference in Proportions|1.68|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
91650566|NCT01769378|183193753|SUPERIORITY_OR_OTHER||LS Squares Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.57|-0.97|||Mixed Models Analysis|||||-0.97|-1.57|<0.001
91650567|NCT01769378|183193754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.001|TWO_SIDED|95.0|3.82|33.84|||Regression, Logistic|Sequential gatekeeping strategy was used to adjust for multiplicity.||\<7.0% HbA1c||33.84|3.82|<0.001
91650568|NCT01769378|183193754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.45|||<|0.001|TWO_SIDED|95.0|3.71|35.34|||Regression, Logistic|||≤6.5% HbA1c||35.34|3.71|<0.001
91650569|NCT01769378|183193755|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.54|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-46.55|-20.53|||ANCOVA|Sequential gatekeeping strategy was used to adjust for multiplicity.||||-20.53|-46.55|<0.001
91650570|NCT01769378|183193756|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.12|TWO_SIDED|95.0|-1.53|0.18|||Mixed Models Analysis|Sequential gatekeeping strategy was used to adjust for multiplicity.||||0.18|-1.53|0.120
91650571|NCT01769378|183193757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.54|0.09||No adjustment for multiplicity|Mixed Models Analysis|||||0.09|-0.54|0.161
91650572|NCT01769378|183193758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-38.49|-19.4|||Mixed Models Analysis|||||-19.40|-38.49|<0.001
91650573|NCT02784106|183193836|SUPERIORITY||Difference in Proportion of Responders|0.1|||||TWO_SIDED|80.0|-0.07|0.25||||||||0.25|-0.07|
91787476|NCT04303195|183454425|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1129|TWO_SIDED|95.0|-0.43|0.05||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.05|-0.43|0.1129
91787477|NCT04303195|183454425|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.459|TWO_SIDED|95.0|-0.33|0.15||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.15|-0.33|0.4590
91787478|NCT04303195|183454426|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.485||0.525|TWO_SIDED|95.0|-1.27|0.65||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.65|-1.27|0.5250
91787479|NCT04303195|183454426|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.498||0.3991|TWO_SIDED|95.0|-1.41|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.41|0.3991
91787480|NCT04303195|183454426|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.497||0.9006|TWO_SIDED|95.0|-1.05|0.92||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.92|-1.05|0.9006
91787481|NCT04303195|183454427|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.444||0.6009|TWO_SIDED|95.0|-1.11|0.64||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.64|-1.11|0.6009
91787482|NCT04303195|183454427|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.454||0.4654|TWO_SIDED|95.0|-1.23|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.23|0.4654
91603308|NCT01375764|183099442|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.5|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|95.0|-74.0|-37.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-37.1|-74.0|<0.001
91603309|NCT01375764|183099442|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-70.8|-34.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-34.5|-70.8|<0.001
91603310|NCT01375764|183099443|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-91.9|STANDARD_ERROR_OF_MEAN|8.4|<|1|TWO_SIDED|95.0|-108.7|-75.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-75.0|-108.7|<0001
91603311|NCT01375764|183099444|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.6|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-40.93|-26.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-26.28|-40.93|<0.001
91603312|NCT01375764|183099444|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.66|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-33.99|-19.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-19.32|-33.99|<0.001
91603313|NCT01375764|183099444|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-24.86|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-32.13|-17.59||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.59|-32.13|<0.001
91603314|NCT01375764|183099445|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-50.81|-39.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-39.18|-50.81|<0.001
91603315|NCT01375764|183099446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Teatment Difference|-29.88|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-36.84|-22.92||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-22.92|-36.84|<0.001
91603316|NCT01375764|183099446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.13|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-29.1|-15.16||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.16|-29.10|<0.001
91523061|NCT02709005|182921491|SUPERIORITY||Risk Difference (RD)|0.14||||0.2|TWO_SIDED|95.0|-0.06|0.33||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants Experiencing Solicited Events between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with solicited urogenital AEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.33|-0.06|0.200
91603317|NCT01375764|183099446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.38|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|-28.29|-14.48||Testing based on a signficance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-14.48|-28.29|<0.001
91603318|NCT01375764|183099447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.23|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.81|-32.64||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.64|-43.81|<0.001
91603319|NCT01375764|183099448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.95|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-37.56|-24.34||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-24.34|-37.56|<0.001
91603320|NCT01375764|183099448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.91|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-30.53|-17.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.29|-30.53|<0.001
91603321|NCT01375764|183099448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-28.92|-15.8||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.80|-28.92|<0.001
91603322|NCT01375764|183099449|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|-43.77|-32.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.07|-43.77|<0.001
91603323|NCT01375764|183099450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.05|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-40.57|-27.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-27.52|-40.57|<0.001
91650574|NCT02784106|183193837|SUPERIORITY||Difference in Mean Changes|-1.93|||||TWO_SIDED|80.0|-5.54|1.69||||||||1.69|-5.54|
91650575|NCT02784106|183193838|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||Day 28||0.06|-0.13|
91650576|NCT02784106|183193838|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.18|0.09||||||Day 56||0.09|-0.18|
91650577|NCT02784106|183193838|SUPERIORITY||Difference in Proportion of Responders|-0.01|||||TWO_SIDED|80.0|-0.15|0.12||||||Day 84||0.12|-0.15|
91787483|NCT04303195|183454427|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.455||0.8842|TWO_SIDED|95.0|-0.83|0.97||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.97|-0.83|0.8842
91603324|NCT01375764|183099450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-33.35|-20.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-20.27|-33.35|<0.001
91603325|NCT01375764|183099450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.1|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-31.57|-18.62||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-18.62|-31.57|<0.001
91603326|NCT01375764|183099451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.25|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.99|-35.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-35.50|-46.99|<0.001
91650578|NCT02784106|183193839|SUPERIORITY||Difference in Proportion of Responders|0.06|||||TWO_SIDED|80.0|0.01|0.14||||||Day 28||0.14|0.01|
91650579|NCT02784106|183193839|SUPERIORITY||Difference in Proportion of Responders|0.03|||||TWO_SIDED|80.0|-0.05|0.11||||||Day 56||0.11|-0.05|
91650580|NCT02784106|183193839|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.15|0.07||||||Day 84||0.07|-0.15|
91650581|NCT02784106|183193840|SUPERIORITY||Difference in Mean Changes|-1.4|||||TWO_SIDED|80.0|-5.37|2.58||||||||2.58|-5.37|
91650582|NCT02784106|183193841|SUPERIORITY||Difference in Mean Changes|-0.08|||||TWO_SIDED|80.0|-0.33|0.16||||||Day 28||0.16|-0.33|
91650583|NCT02784106|183193841|SUPERIORITY||Difference in Mean Changes|0.07|||||TWO_SIDED|80.0|-0.29|0.43||||||Day 84||0.43|-0.29|
91650584|NCT02784106|183193842|SUPERIORITY||Difference in Proportion of Participants|0.08|||||TWO_SIDED|80.0|-0.04|0.21||||||||0.21|-0.04|
91650585|NCT02784106|183193843|SUPERIORITY||Difference in Proportion of Participants|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||||0.06|-0.13|
91650586|NCT02927847|183193871|OTHER||t-value|0.138||||0.891|TWO_SIDED||||||t-test, 2 sided|||||||0.891
91787484|NCT01808092|183454442|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-4.2||||0.007|TWO_SIDED|95.0|-10.76|2.46||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set||2.46|-10.76|0.007
91650587|NCT02927847|183193872|OTHER||t-value|-0.575||||0.571|TWO_SIDED||||||t-test, 2 sided|||||||0.571
91523062|NCT02709005|182921492|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|||||No SAEs were reported; therefore the Fisher's Exact Test was not performed.||||The null hypothesis was that there was no difference in participants with related SAEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||||
91650588|NCT02927847|183193873|OTHER||Odds Ratio (OR)|1.17||||0.739|TWO_SIDED||||||Regression, Cox|||||||0.739
91650589|NCT03882047|183193911|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650590|NCT03882047|183193911|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650591|NCT03882047|183193911|OTHER|||||||0.03|||||||ANOVA|||||||0.03
91650592|NCT03882047|183193912|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650593|NCT03882047|183193912|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650594|NCT03882047|183193912|OTHER|||||||0.31|||||||ANOVA|||||||0.31
91650595|NCT03882047|183193913|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650596|NCT03882047|183193913|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650597|NCT03882047|183193913|OTHER|||||||0.01|||||||ANOVA|||||||0.01
91650598|NCT03882047|183193914|OTHER|||||||0.08|||||||ANOVA|||||||0.08
91650599|NCT03882047|183193914|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650600|NCT03882047|183193914|OTHER|||||||0.1|||||||ANOVA|||||||0.10
91650601|NCT03882047|183193915|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650602|NCT03882047|183193915|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650603|NCT03882047|183193915|OTHER|||||||0.01|||||||ANOVA|||||||0.01
91650604|NCT03882047|183193916|OTHER|||||||0.02|||||||ANOVA|||||||0.02
91650605|NCT03882047|183193916|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650606|NCT03882047|183193916|OTHER|||||||0.05|||||||ANOVA|||||||0.05
91650607|NCT03882047|183193917|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650608|NCT03882047|183193917|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650609|NCT03882047|183193917|OTHER|||||||0.06|||||||ANOVA|||||||0.06
91650610|NCT03882047|183193918|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91603327|NCT01194440|183099514|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Bonferonni|Adjusting for multiple comparisons in the analyses, a Bonferonni-corrected p-value of 0.05/5 = 0.01 to represent statistical significance was used.||The primary hypothesis of the study is that administration of zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS compared to letrozole treatment alone (historical control).||||<0.001
91650611|NCT03882047|183193918|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650612|NCT03882047|183193918|OTHER|||||||0.46|||||||ANOVA|||||||0.46
91650613|NCT03882047|183193919|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91603328|NCT01552343|183099525|SUPERIORITY_OR_OTHER|||||||0.0187||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Correlation - no adjustments||||0.0187
91650614|NCT03882047|183193919|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650615|NCT03882047|183193919|OTHER|||||||0.07|||||||ANOVA|||||||0.07
91603329|NCT01552343|183099525|SUPERIORITY_OR_OTHER|||||||0.0094||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline # of voids||||0.0094
91603330|NCT01552343|183099525|SUPERIORITY_OR_OTHER|||||||0.0383||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline NI total score||||0.0383
91603331|NCT01552343|183099525|SUPERIORITY_OR_OTHER|||||||0.0133||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - age category||||0.0133
91650616|NCT03882047|183193920|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650617|NCT03882047|183193920|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650618|NCT03882047|183193920|OTHER|||||||0.53|||||||ANOVA|||||||0.53
91650619|NCT03882047|183193921|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650620|NCT03882047|183193921|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91650621|NCT03882047|183193921|OTHER|||||||0.12|||||||ANOVA|||||||0.12
91650622|NCT00475852|183193941|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.7||||0.313|TWO_SIDED|95.0|-2.1|0.7|||Cochran-Mantel-Haenszel|Stratified by geographical region.||||0.7|-2.1|0.313
91650623|NCT00475852|183193942|SUPERIORITY_OR_OTHER|||||||0.03|||||||Van Elteren test|Controlled for region.||||||0.030
91650624|NCT00475852|183193943|SUPERIORITY_OR_OTHER|||||||0.007|||||||Van Elteren test|Controlled for region.||||||0.007
91650625|NCT00475852|183193944|SUPERIORITY_OR_OTHER|||||||0.318|||||||Van Elteren test|Controlled for region.||||||0.318
91650626|NCT00475852|183193945|SUPERIORITY_OR_OTHER|||||||0.018|||||||Van Elteren test|Controlled for region.||||||0.018
91650627|NCT00475852|183193946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.295|TWO_SIDED|95.0|-1.5|0.5|||Cochran-Mantel-Haenszel|Controlled for region.||||0.5|-1.5|0.295
91650628|NCT00475852|183193947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.16|||||||ANOVA|Controlled for region.|This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.|||||0.160
91650629|NCT00475852|183193948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.9||||0.238|TWO_SIDED|95.0|-2.4|0.6|||Cochran-Mantel-Haenszel|Controlled for region.|For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.|||0.6|-2.4|0.238
91650630|NCT00475852|183193952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.109|TWO_SIDED|95.0|0.98|1.21|||Cochran-Mantel-Haenszel|Controlled for region.||||1.21|0.98|0.109
91650631|NCT03563027|183193961|SUPERIORITY||Mean Difference (Net)|433.0||||0.81|TWO_SIDED|95.0|-337.0|1203.0|||Regression, Linear|||||1203|-337|.81
91650632|NCT03563027|183193961|SUPERIORITY||Mean Difference (Net)|1224.0||||0.005|TWO_SIDED|95.0|451.0|1996.0|||Regression, Linear|||||1996|451|.005
91650633|NCT03563027|183193962|SUPERIORITY||Mean Difference (Net)|-160.0||||0.92|TWO_SIDED|95.0|-983.0|663.0|||Regression, Linear|||||663|-983|.92
91650634|NCT03563027|183193962|SUPERIORITY||Mean Difference (Net)|564.0||||0.37|TWO_SIDED|95.0|-261.0|1389.0|||Regression, Linear|||||1389|-261|.37
91650635|NCT03563027|183193963|SUPERIORITY||Median Difference (Net)|0.21|||<|0.001|TWO_SIDED|95.0|0.18|0.24|||Regression, Linear|||||.24|.18|<.001
91650636|NCT03563027|183193963|SUPERIORITY||Mean Difference (Net)|0.34|||<|0.001|TWO_SIDED|95.0|0.31|0.37|||Regression, Linear|||||.37|.31|<.001
91650637|NCT03563027|183193964|SUPERIORITY||Mean Difference (Net)|0.09|||<|0.001|TWO_SIDED|95.0|0.06|0.1|||Regression, Linear|||||0.1|.06|<.001
91650638|NCT03563027|183193964|SUPERIORITY||Median Difference (Net)|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.2|||Regression, Linear|||||.20|.15|<.001
91650639|NCT02444533|183194051|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.||||0.043
91650640|NCT02444533|183194051|SUPERIORITY|||||||0.445|||||||t-test, 2 sided|||Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.||||0.445
91650641|NCT02444533|183194052|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.||||0.650
91650642|NCT02444533|183194052|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.||||0.970
91650643|NCT02444533|183194052|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.||||0.835
91650644|NCT02444533|183194053|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.||||1.0
91787485|NCT01808092|183454443|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-0.7|||<|0.001|TWO_SIDED|95.0|-7.86|6.39||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set||6.39|-7.86|<0.001
91787486|NCT04219085|183454491|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.0
91787487|NCT04219085|183454492|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91787488|NCT04219085|183454493|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
91787489|NCT01909011|183454501|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91787490|NCT01909011|183454502|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||t-test, 2 sided|||||||0.066
91787491|NCT01909011|183454503|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
91603332|NCT01552343|183099525|SUPERIORITY_OR_OTHER|||||||0.0128||95.0|||||t-test, 2 sided|The a priori threshold for statistical significance was 0.05.||Partial correlation - gender||||0.0128
91603333|NCT01552343|183099526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7|||||TWO_SIDED|95.0|2.7|18.8|||||Non-Responders - Responders|Nocturia Impact (NI) Total Score (Q1-Q11)||18.8|2.7|
91650645|NCT01488019|183194085|NON_INFERIORITY|The hazard ratio and 90% two-sided confidence interval for the hazard ratio comparing Perforomist to placebo were estimated. Non-inferiority was declared if the upper limit of the two-sided 90% confidence interval was wholly less than 1.5.|Hazard Ratio (HR)|0.965|||||TWO_SIDED|90.0|0.711|1.308||Hazard Ratio was calculated as Perforomist vs Placebo. The non-inferiority margin for the hazard ratio is 1.5. Subjects with no primary event at withdrawal or study completion were treated as censored observations at time of withdrawal|Regression, Cox|Treatment, site group, and bronchodilator reversibility included as covariates in the model.|Hazard Ratio was calculated as Perforomist Inhalation Solution vs Placebo. The non-inferiority margin for the hazard ratio is 1.5.|||1.308|0.711|
91650646|NCT02173301|183194112|SUPERIORITY|||||||0.066|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.066
91650647|NCT02173301|183194112|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.001
91787492|NCT03425253|183454505|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Both Sides of Face, Last Treatment||||<0.001
91787493|NCT03425253|183454505|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Right Side of Face, Last Treatment||||<0.001
91787494|NCT03425253|183454505|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Left Side of Face, Last Treatment||||<0.001
91787495|NCT03425253|183454505|OTHER|||||||0.018||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Both Sides of Face, Last Treatment||||0.018
91787496|NCT03425253|183454505|OTHER|||||||0.301||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Right Side of Face, Last Treatment||||0.301
91787497|NCT03425253|183454505|OTHER|||||||0.011||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Left Side of Face, Last Treatment||||0.011
91603334|NCT01552343|183099526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-9.6|9.6|||||Non-Responders - Responders|Overall Impact Question (Q12)||9.6|-9.6|
91603335|NCT01552343|183099529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6||||0.1471|TWO_SIDED|95.0|-20.3|3.1||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Screening||3.1|-20.3|0.1471
91603336|NCT01552343|183099529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.0318|TWO_SIDED|95.0|-26.0|-1.2||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Baseline||-1.2|-26.0|0.0318
91650648|NCT02173301|183194112|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||<0.001
91650649|NCT02173301|183194113|SUPERIORITY|||||||0.501|||||||Regression, Logistic|||Week 12 comparison||||0.501
91650650|NCT02173301|183194113|SUPERIORITY|||||||0.34|||||||Regression, Logistic|||Week 12 comparison||||0.340
91650651|NCT02173301|183194113|SUPERIORITY|||||||0.075|||||||Regression, Logistic|||Week 12 comparison||||0.075
91787498|NCT03425253|183454506|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
91787499|NCT03425253|183454507|OTHER|||||||0.597||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.597
91787500|NCT03425253|183454508|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
91787501|NCT03425253|183454509|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
91787502|NCT03425253|183454510|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
91787503|NCT03425253|183454511|OTHER|||||||0.003||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.003
91787504|NCT03425253|183454512|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Both Side of the Face, End of Study||||<0.001
91787505|NCT03425253|183454512|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Right Side of the Face, End of study||||<0.001
91787506|NCT03425253|183454512|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Left Side of the Face, End of Study||||<0.001
91787507|NCT00695097|183454513|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline)compared to post-treatment (follow-up) CD3 cell density||||0.25
91787508|NCT00695097|183454513|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline) compared to post-treatment (follow-up) CD3 cell density||||0.46
91787509|NCT00695097|183454513|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||pretreatment (baseline) compared to post-treatment (follow-up) biopsy CD20 cell density||||0.054
91787510|NCT00695097|183454513|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (baseline) compared to post-treatment (follow-up) CD20 cell density||||0.62
91603337|NCT01552343|183099529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.8||||0.0463|TWO_SIDED|95.0|-31.2|-0.3||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Screening||-0.3|-31.2|0.0463
91603338|NCT01552343|183099529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7||||0.0413|TWO_SIDED|95.0|-34.6|-0.7||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Baseline||-0.7|-34.6|0.0413
91603339|NCT01552343|183099530|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-6.6|6.3|||ANCOVA|Covariates baseline score, treatment and age stratum (\<65, \>=65).||Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.||6.3|-6.6|0.9647
91603340|NCT01078805|183099533|SUPERIORITY_OR_OTHER|||||||0.0177||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0177
91603341|NCT01078805|183099533|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0019
91603342|NCT01078805|183099533|SUPERIORITY_OR_OTHER|||||||0.0143||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0143
91603343|NCT01078805|183099534|SUPERIORITY_OR_OTHER|||||||0.0689||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0689
91650652|NCT02173301|183194114|SUPERIORITY|||||||0.229|||||||Regression, Logistic|||Week 12 comparison||||0.229
91787511|NCT00982423|183454522|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between baseline dose of furosemide (3 weeks) versus reduced dose of furosemide (approximately 6 weeks).||||<0.05
91787512|NCT00982423|183454522|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Comparison between GFR taken at baseline dose Furosemide (3 weeks) versus normal GFR||||<0.05
91603344|NCT01078805|183099534|SUPERIORITY_OR_OTHER|||||||0.0412||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0412
91603345|NCT01078805|183099534|SUPERIORITY_OR_OTHER|||||||0.0631||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0631
91603346|NCT01078805|183099535|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91603347|NCT01078805|183099536|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91603348|NCT04722991|183099547|OTHER|Bayesian inference with non-informative priors|Point estimate|-0.015|||||TWO_SIDED|95.0|-0.08|0.029|||||Median of posterior distribution|||0.029|-0.080|
91603349|NCT02246621|183099564|SUPERIORITY||Hazard Ratio (HR)|0.54||||2e-06|TWO_SIDED|95.0|0.418|0.698|||Log Rank|||||0.698|0.418|0.000002
91603350|NCT02246621|183099566|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
91603351|NCT02246621|183099568|SUPERIORITY|||||||0.501|||||||Cochran-Mantel-Haenszel|||||||0.501
91603352|NCT02246621|183099569|SUPERIORITY|||||||0.101|||||||Cochran-Mantel-Haenszel|||||||0.101
91603353|NCT02246621|183099573|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.688|TWO_SIDED||||||Mixed Models Analysis|||||||0.688
91603354|NCT02246621|183099574|SUPERIORITY||Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|1.39||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
91603355|NCT00821678|183099577|SUPERIORITY_OR_OTHER||Slope|-3.81||||0.002|TWO_SIDED|95.0|-6.19|-1.43|||Mixed Models Analysis|||||-1.43|-6.19|0.002
91603356|NCT00821678|183099578|SUPERIORITY_OR_OTHER||Slope|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.1|-0.4|0.001
91603357|NCT00821678|183099579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.7|||t-test, 2 sided|||||0.70|-0.33|0.48
91603358|NCT00821678|183099580|SUPERIORITY_OR_OTHER||Slope|2.67||||0.02|TWO_SIDED|95.0|0.45|4.91|||Mixed Models Analysis|||||4.91|0.45|0.02
91603359|NCT00821678|183099583|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.86||||0.65|TWO_SIDED|95.0|0.46|1.62|||Mixed Models Analysis|||||1.62|0.46|0.65
91650653|NCT02173301|183194114|SUPERIORITY|||||||0.604|||||||Regression, Logistic|||Week 12 comparison||||0.604
91650654|NCT02173301|183194114|SUPERIORITY|||||||0.573|||||||Regression, Logistic|||Week 12 comparison||||0.573
91787513|NCT00982423|183454527|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Comparison between reduced dose Furosemide and baseline dose Furosemide||||0.075
91787514|NCT04174365|183454528|SUPERIORITY||Least squares (LS) mean difference|-1.22||||0.4597|TWO_SIDED|95.0|-4.49|2.05|||Mixed model repeated measures(MMRM)|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||2.05|-4.49|0.4597
91603360|NCT00821678|183099584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.9|||<|0.001|TWO_SIDED|95.0|3.2|19.6|||Mixed Models Analysis|||||19.6|3.2|<0.001
91603361|NCT02732951|183099592|OTHER||Adjusted Mean|16.45|STANDARD_ERROR_OF_MEAN|16.45||0.3199|TWO_SIDED|95.0|-16.23|49.13|||Mixed model for repeated measurements|Kenward-Roger approximation was used for denominator degrees of freedom.|Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.|Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups||49.13|-16.23|0.3199
91603362|NCT00391599|183099624|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Chi-squared|||||||0.15
91603363|NCT00391599|183099626|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91603364|NCT00928070|183099653|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.21||0.0018|TWO_SIDED|95.0|-1.05|-0.24||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.24|-1.05|0.0018
91603365|NCT00928070|183099654|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.27|-0.38||Statistical testing, two-sided, was done at 5% significance level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.38|-1.27|0.0003
91603366|NCT00928070|183099655|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
91603367|NCT00928070|183099655|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
91603368|NCT00928070|183099657|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.35|-0.4||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.40|-1.35|0.0003
91709532|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6334|TWO_SIDED|95.0|-9.7|5.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||5.9|-9.7|0.6334
91603369|NCT00928070|183099657|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.29|-0.39||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.39|-1.29|0.0003
91603370|NCT00928070|183099658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
91603371|NCT00928070|183099658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
91603372|NCT00928070|183099660|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0014|TWO_SIDED|95.0|-1.77|-0.43||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.43|-1.77|0.0014
91603373|NCT00928070|183099660|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.70|-2.10|<0.0001
91603374|NCT00928070|183099661|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0002
91603375|NCT00928070|183099661|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
91709533|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.1788|TWO_SIDED|95.0|-11.4|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||2.1|-11.4|0.1788
91790592|NCT02880956|183460070|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91603376|NCT00928070|183099663|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2511|TWO_SIDED|95.0|-0.39|0.1||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||0.10|-0.39|0.2511
91603377|NCT00928070|183099663|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.0189|TWO_SIDED|95.0|-0.53|-0.05||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||-0.05|-0.53|0.0189
91603378|NCT00928070|183099664|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% significance level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0010
91603379|NCT00928070|183099666|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.04|-2.3||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.30|-7.04|0.0001
91603380|NCT00928070|183099666|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.97|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-7.27|-2.66||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.66|-7.27|<0.0001
91603381|NCT00928070|183099667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0035|TWO_SIDED|95.0|-0.56|-0.11||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: =\<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.11|-0.56|0.0035
91603382|NCT00928070|183099667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.21||0.7089|TWO_SIDED|95.0|-2.01|2.92||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: \>3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||2.92|-2.01|0.7089
91603383|NCT00928070|183099667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: =\<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.21|-0.61|<0.0001
91603384|NCT00928070|183099667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.47||0.7437|TWO_SIDED|95.0|-0.78|1.09||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: \>2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||1.09|-0.78|0.7437
91603385|NCT00928070|183099668|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0009
91603386|NCT00928070|183099668|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0021
91709534|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-7.6||||0.0292|TWO_SIDED|95.0|-14.4|-0.8|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.8|-14.4|0.0292
91603387|NCT00928070|183099670|SUPERIORITY_OR_OTHER||Least squares mean difference|-9.15|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-12.85|-5.45||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-5.45|-12.85|<0.0001
91709535|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-8.8||||0.0371|TWO_SIDED|95.0|-17.1|-0.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.5|-17.1|0.0371
91790593|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.064||0.867|TWO_SIDED|95.0|-0.115|0.137||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.137|-0.115|0.867
91790594|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790595|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063||0.898|TWO_SIDED|95.0|-0.132|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.116|-0.132|0.898
91603388|NCT00928070|183099670|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.03||0.0002|TWO_SIDED|95.0|-11.6|-3.61||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-3.61|-11.60|0.0002
91603389|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|8.17|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|4.09|12.25||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||12.25|4.09|<0.0001
91603390|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|6.96|STANDARD_ERROR_OF_MEAN|2.13||0.0012|TWO_SIDED|95.0|2.77|11.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||11.15|2.77|0.0012
91603391|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|2.01||0.0472|TWO_SIDED|95.0|0.05|7.95||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.95|0.05|0.0472
91603392|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|2.46|STANDARD_ERROR_OF_MEAN|1.53||0.1087|TWO_SIDED|95.0|-0.55|5.46||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.46|-0.55|0.1087
91603393|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|5.79|STANDARD_ERROR_OF_MEAN|1.77||0.0012|TWO_SIDED|95.0|2.31|9.28||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.28|2.31|0.0012
91603394|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|9.04|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|4.75|13.33||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||13.33|4.75|<0.0001
91603395|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|5.32|STANDARD_ERROR_OF_MEAN|2.22||0.0169|TWO_SIDED|95.0|0.96|9.67||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.67|0.96|0.0169
91603396|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.1||0.0546|TWO_SIDED|95.0|-0.08|8.17||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||8.17|-0.08|0.0546
91603397|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|2.35|STANDARD_ERROR_OF_MEAN|1.63||0.1497|TWO_SIDED|95.0|-0.85|5.55||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.55|-0.85|0.1497
91603398|NCT00928070|183099672|SUPERIORITY_OR_OTHER||Least squares mean difference|5.53|STANDARD_ERROR_OF_MEAN|1.88||0.0034|TWO_SIDED|95.0|1.84|9.23||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.23|1.84|0.0034
91709536|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.2971|TWO_SIDED|95.0|-11.3|3.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||3.5|-11.3|0.2971
91603399|NCT00928070|183099673|SUPERIORITY_OR_OTHER||Least squares mean difference|16.25|STANDARD_ERROR_OF_MEAN|2.96|<|0.0001|TWO_SIDED|95.0|10.43|22.08||Statistical testing, two-sided, was done at 5% significance level.|ANOVA|||ANOVA model with treatment and center as factors was used to calculate p-value.||22.08|10.43|<0.0001
91603400|NCT00928070|183099674|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.||||<0.0001
91603401|NCT00928070|183099676|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2788|TWO_SIDED|95.0|-0.51|0.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.||0.15|-0.51|0.2788
91603402|NCT00928070|183099677|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0||||0.0021|TWO_SIDED|95.0|0.0|8.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||8.00|0.00|0.0021
91603403|NCT00928070|183099677|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.0|||<|0.0001|TWO_SIDED|95.0|3.0|11.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||11.00|3.00|<0.0001
91709537|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.015|TWO_SIDED|95.0|-17.2|-1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||-1.9|-17.2|0.0150
91523063|NCT02709005|182921493|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.13|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.08|-0.13|>0.999
91523064|NCT02709005|182921494|SUPERIORITY||Risk Difference (RD)|-0.09||||0.035|TWO_SIDED|95.0|-0.24|-0.01||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||-0.01|-0.24|0.035
91523065|NCT02709005|182921499|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.18|0.14||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.14|-0.18|>0.999
91523066|NCT02634788|182921504|OTHER||LS Mean Difference|81.93|STANDARD_ERROR_OF_MEAN|14.283|<|0.0001|TWO_SIDED|95.0|53.82|110.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||110.04|53.82|<0.0001
91603404|NCT00624520|183099700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|891.0||||0.18|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.18
91603405|NCT00624520|183099701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
91603406|NCT00624520|183099702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED||||||ANOVA|||||||0.003
91603407|NCT00624520|183099703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.011|TWO_SIDED||||||ANOVA|||||||0.011
91603408|NCT00624520|183099704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.048|TWO_SIDED||||||ANOVA|||||||0.048
91603409|NCT00624520|183099705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91603410|NCT00624520|183099706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91603411|NCT00624520|183099707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91603412|NCT00624520|183099708|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
91603413|NCT00624520|183099709|SUPERIORITY_OR_OTHER||Effect size (Cohen's d)|0.38||||0.025|TWO_SIDED|||||P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.|ANCOVA||Range of Cohen's d for small effect is 0.20 - 0.50|||||0.025
91603414|NCT00624520|183099710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80.0||||0.81|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.81
91603415|NCT01570244|183099731|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|140.96|STANDARD_DEVIATION|8.1|||TWO_SIDED|90.0|133.84|148.47|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||148.47|133.84|
91603416|NCT01570244|183099732|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Odds Ratio (OR)|114.82|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|105.49|124.97|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||124.97|105.49|
91603417|NCT01570244|183099733|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|171.37|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|160.2|183.33|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||183.33|160.20|
91523067|NCT02634788|182921504|OTHER||LS Mean Difference|36.18|STANDARD_ERROR_OF_MEAN|14.099||0.0108|TWO_SIDED|95.0|8.43|63.93|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.93|8.43|0.0108
91603418|NCT01570244|183099736|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric mean ratio|140.53|STANDARD_DEVIATION|4.6|||TWO_SIDED|90.0|136.4|144.78|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||144.78|136.40|
91603419|NCT01570244|183099737|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.28|STANDARD_DEVIATION|6.1|||TWO_SIDED|90.0|110.81|119.92|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||119.92|110.81|
91603420|NCT01570244|183099738|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|153.85|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|145.99|162.14|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||162.14|145.99|
91650655|NCT04444752|183194141|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gate-keeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared to placebo group in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical signficance at p=0.05 level was not achieved.|Mean Difference (Final Values)|23.36|STANDARD_ERROR_OF_MEAN|6.794||0.0007|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg dose Q2W 3. 300 mg dose Q4W vs placebo|ANCOVA|The data were analyzed using an ANCOVA model adjusted for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The primary efficacy analysis includes comparison of percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q2W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0007
91650656|NCT04444752|183194141|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with the placebo group in order from the highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at 0.05 level was not achieved.|Mean Difference (Final Values)|17.89|STANDARD_ERROR_OF_MEAN|6.537||0.0067|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were analyzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 150 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0067
91709538|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.1245|TWO_SIDED|95.0|-15.8|1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||1.9|-15.8|0.1245
91523068|NCT02634788|182921504|OTHER||LS Mean Difference|35.46|STANDARD_ERROR_OF_MEAN|14.02||0.012|TWO_SIDED|95.0|7.86|63.05|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.05|7.86|0.0120
91523069|NCT01591382|182921561|SUPERIORITY_OR_OTHER|||||||0.0241||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.0241
91523070|NCT01591382|182921562|SUPERIORITY_OR_OTHER|||||||0.4102||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4102
91523071|NCT01591382|182921563|SUPERIORITY_OR_OTHER|||||||0.1085||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.1085
91523072|NCT01591382|182921564|SUPERIORITY_OR_OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.7480
91523073|NCT00558064|182921612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|3.98|6.23|||Mixed Models Analysis||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus amlodipine 5 mg monotherapy|||6.23|3.98|<0.0001
91523074|NCT02401464|182921649|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|Least Squares (LS) mean difference (ln)|0.963|||||TWO_SIDED|90.0|0.927|1.001||||||Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.||1.001|0.927|
91603421|NCT03486392|183099742|SUPERIORITY||Difference of least square (LS) Means|-6.75|STANDARD_ERROR_OF_MEAN|1.056|<|0.001|TWO_SIDED|95.0|-9.31|-4.19|||Dunnett's method|||||-4.19|-9.31|< 0.001
91603422|NCT03486392|183099742|SUPERIORITY||Difference of LS Means|-8.07|STANDARD_ERROR_OF_MEAN|0.921|<|0.001|TWO_SIDED|95.0|-10.31|-5.84|||Dunnett's method|||||-5.84|-10.31|< 0.001
91603423|NCT03486392|183099742|SUPERIORITY||Difference of LS Means|-10.04|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-12.31|-7.78|||Dunnett's method|||||-7.78|-12.31|< 0.001
91603424|NCT03486392|183099742|SUPERIORITY||Difference of LS Means|-5.78|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|-7.99|-3.57|||Dunnett's method|||||-3.57|-7.99|< 0.001
91603425|NCT02304926|183099749|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603426|NCT02304926|183099750|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603427|NCT02304926|183099751|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603428|NCT02304926|183099752|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91603429|NCT02304926|183099753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91603430|NCT02304926|183099754|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603431|NCT02304926|183099755|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603432|NCT02304926|183099756|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603433|NCT02304926|183099757|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603434|NCT02304926|183099758|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603435|NCT02304926|183099759|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91650657|NCT04444752|183194141|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with placebo in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at the 0.05 level was not achieved.|Mean Difference (Final Values)|23.83|STANDARD_ERROR_OF_MEAN|6.575||0.0004|TWO_SIDED|||||Adjusted for mulitplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were anlayzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI||"The efficacy analysis includes comparing percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q4W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q4W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0004
91650658|NCT04444752|183194142|SUPERIORITY|The secondary efficacy analysis includes comparison of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16 for each CBP-201 300 mg Q2W vs placebo.|Difference in vIGA Response Rate|28.1||||0.0089|TWO_SIDED|||||There were no adjustments for multiple comparisons. For IGA response, counts, percentage, and 95% CIs obtained using the Clopper-Pearson method and were presented for pairwise comparisons for each CBP-201 group vs. placebo.|Chi-squared|||Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16.||||0.0089
91603436|NCT02304926|183099760|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603437|NCT02304926|183099761|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603438|NCT02304926|183099762|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603439|NCT02304926|183099763|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603440|NCT02304926|183099764|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603441|NCT02304926|183099765|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603442|NCT02304926|183099766|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91603443|NCT02304926|183099767|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603444|NCT02304926|183099768|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91603445|NCT02076165|183099775|SUPERIORITY||||||=|0.12|||||||Fisher Exact|||Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.||||=.120
91603446|NCT02076165|183099776|SUPERIORITY||Mean Difference (Final Values)|-0.711|STANDARD_ERROR_OF_MEAN|3.59|=|0.843|TWO_SIDED|95.0|-7.75|6.32|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual bed time. Negative values indicate the number of minutes earlier than the recommended bed time that the participant went to bed, indicating greater non-adherence.|||6.32|-7.75|=.843
91603447|NCT02076165|183099777|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|5.17|=|0.59|TWO_SIDED|95.0|-12.91|7.35|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual rise time. Positive values indicate the number of minutes later than the recommended rise time that the participant got out of bed, indicating greater non-adherence.|||7.35|-12.91|=0.590
91603448|NCT02076165|183099778|SUPERIORITY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.048|=|0.979|TWO_SIDED|95.0|-0.093|0.096|||Mixed Models Analysis||The proportion of nights participants who did not follow the recommendation to get out of bed if awake more than 20 minutes. Higher numbers indicate greater non-adherence.|||0.096|-0.093|=0.979
91603449|NCT02076165|183099779|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.409|STANDARD_ERROR_OF_MEAN|2.02|=|0.004|TWO_SIDED|90.0|-2.92|3.74|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||3.74|-2.92|=0.004
91603450|NCT02076165|183099780|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.757|STANDARD_ERROR_OF_MEAN|2.12||0.003|TWO_SIDED|90.0|-2.72|4.23|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||4.23|-2.72|.003
91603451|NCT02076165|183099781|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|90.0|-1.21|2.57|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||2.57|-1.21|<0.001
91709539|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.1591|TWO_SIDED|95.0|-12.7|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||2.1|-12.7|0.1591
91650659|NCT00433381|183194144|OTHER|||||||||||||||||Null hypothesis: 20% of patients progression-free at six months. Alternative hypothesis: 35%. Type I and II error rates = 0.10. Required sample size = 57.|The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
91709540|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-7.3||||0.06|TWO_SIDED|95.0|-14.8|0.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||0.3|-14.8|0.0600
91523075|NCT02401464|182921650|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.906|||||TWO_SIDED|90.0|0.88|0.933||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||0.933|0.880|
91523076|NCT02401464|182921651|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.985|||||TWO_SIDED|90.0|0.958|1.011||||||Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.011|0.958|
91603452|NCT02076165|183099782|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|90.0|-1.14|3.36|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||3.36|-1.14|<.001
91709541|NCT04378569|183311579|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.464|TWO_SIDED|95.0|-12.0|5.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||5.5|-12.0|0.4640
91709542|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.066||||0.3184|TWO_SIDED|95.0|-0.196|0.064|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.064|-0.196|0.3184
91790596|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790597|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.065||0.537|TWO_SIDED|95.0|-0.088|0.168||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.168|-0.088|0.537
91790598|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790599|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.074||0.176|TWO_SIDED|95.0|-0.245|0.045||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.045|-0.245|0.176
91790600|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790601|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.072||0.125|TWO_SIDED|95.0|-0.251|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.031|-0.251|0.125
91790602|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790603|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.074||0.676|TWO_SIDED|95.0|-0.176|0.114||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||week 48||0.114|-0.176|0.676
91603453|NCT02076165|183099783|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|0.501|STANDARD_ERROR_OF_MEAN|0.9|=|0.048|TWO_SIDED|90.0|-0.98|1.98|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||1.98|-0.98|=0.048
91709543|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.013||||0.8514|TWO_SIDED|95.0|-0.149|0.123|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.123|-0.149|0.8514
91603454|NCT02076165|183099784|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|1.06|=|0.008|TWO_SIDED|90.0|-2.32|1.17|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||1.17|-2.32|=0.008
91603455|NCT01950819|183099785|NON_INFERIORITY|p vale for non inferiority margin is 10 %|Odds Ratio (OR)|3.0||||0.001|TWO_SIDED|95.0|-1.4|7.3|||Logistic Regression Model|||calculated at month 12||7.3|-1.4|0.001
91603456|NCT00820573|183099807|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"A general unstructured variance-covariance matrix (ANOVA) was applied for measurements at different periods. Between-group comparisons after 6 wks of treatment were assessed using the ANOVA model at alpha=0.05 (two-sided).~16 subjects provide \~90% power to detect difference in EGP of 0.28 mg/kg.min (95% CI = 0.17 mg/kg.min)."||||<0.05
91603457|NCT00820573|183099808|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||multivariate analysis was performed to compare results amongst all four groups||||<0.05
91787515|NCT04174365|183454529|SUPERIORITY||LS mean difference|-0.07||||0.7315|TWO_SIDED|95.0|-0.46|0.32|||MMRM|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||0.32|-0.46|0.7315
91603458|NCT00820573|183099809|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||ANOVA||||0.05
91603459|NCT00820573|183099810|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
91603460|NCT01360645|183099811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0001|TWO_SIDED|95.0|-4.7|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-1.54|-4.70|0.0001
91603461|NCT01360645|183099812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21||||0.0002|TWO_SIDED|95.0|-4.87|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-1.54|-4.87|0.0002
91603462|NCT01360645|183099813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0372|TWO_SIDED|95.0|-0.86|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.86|0.0372
91603463|NCT01360645|183099814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0349|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.88|0.0349
91603464|NCT01360645|183099815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.008|TWO_SIDED|95.0|-2.25|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.25|0.0080
91603465|NCT01360645|183099815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.0045|TWO_SIDED|95.0|-2.91|-0.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.54|-2.91|0.0045
91603466|NCT01360645|183099815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.0001|TWO_SIDED|95.0|-3.96|-1.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.30|-3.96|0.0001
91603467|NCT01360645|183099815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.0004|TWO_SIDED|95.0|-4.01|-1.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.18|-4.01|0.0004
91603468|NCT01360645|183099815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0|TWO_SIDED|95.0|-4.68|-1.7|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-1.70|-4.68|0.0000
91603469|NCT01360645|183099816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0086|TWO_SIDED|95.0|-2.28|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.28|0.0086
91603470|NCT01360645|183099816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0149|TWO_SIDED|95.0|-2.74|-0.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.30|-2.74|0.0149
91603471|NCT01360645|183099816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.0006|TWO_SIDED|95.0|-3.78|-1.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.05|-3.78|0.0006
91603472|NCT01360645|183099816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.0009|TWO_SIDED|95.0|-4.0|-1.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.04|-4.00|0.0009
91787516|NCT05141448|183454531|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.011|||TWO_SIDED|95.0|0.02|0.06|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as senofilcon A C3 (EMO-118) minus omafilcon A|||0.06|0.02|
91787517|NCT01330017|183454538|SUPERIORITY_OR_OTHER|||||||0.4912||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4912
91787518|NCT01330017|183454538|SUPERIORITY_OR_OTHER|||||||0.4519||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4519
91787519|NCT01330017|183454538|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.2186
91787520|NCT01330017|183454538|SUPERIORITY_OR_OTHER|||||||0.5983||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.5983
91787521|NCT03137069|183454559|SUPERIORITY||Least Squares Mean Difference|-7.02||||0.0559|TWO_SIDED|90.0|-13.01|-1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-1.03|-13.01|0.0559
91787522|NCT03137069|183454559|SUPERIORITY||Least Squares Mean Difference|-0.51||||0.8892|TWO_SIDED|90.0|-6.6|5.58|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||5.58|-6.60|0.8892
91787523|NCT03137069|183454559|SUPERIORITY||Least Squares Mean Difference|-6.43||||0.0717|TWO_SIDED|90.0|-12.29|-0.57|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-0.57|-12.29|0.0717
91523077|NCT02401464|182921652|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.979|||||TWO_SIDED|90.0|0.938|1.022||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.022|0.938|
91523078|NCT01337986|182921658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Mixed Models Analysis|||Per protocol Analysis||||0.84
91523079|NCT01337986|182921658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|||Change in EDTRS between Visits 2 and 3.||||.29
91523080|NCT01337986|182921660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.01||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null hypothesis: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity with dalfampridine vs placebo.||||.64
91603473|NCT01360645|183099816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28||||0|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-3.28|-4.84|0.0000
91603474|NCT01360645|183099817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0022|TWO_SIDED|95.0|-0.38|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.08|-0.38|0.0022
91523081|NCT01337986|182921660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Mixed Models Analysis|||Null hypothesis for period effect: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity for those who started on dalfampridine and crossed over to placebo, compared to those who started on placebo and crossed over to dalfampridine.||||0.11
91523082|NCT01337986|182921661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Regression, Logistic|||||||0.93
91523083|NCT01337986|182921662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Regression, Logistic|||||||.34
91523084|NCT01337986|182921664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.04|TWO_SIDED|95.0|1.02|2.1||Probability of being in the lowest quartile for Visual Field Index deficits.|Regression, Logistic||Odds Ratio for Visual Field Index|||2.10|1.02|0.04
91523085|NCT01337986|182921665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Regression, Logistic|||||||0.94
91603475|NCT01360645|183099817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0115|TWO_SIDED|95.0|-0.38|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.05|-0.38|0.0115
91603476|NCT01360645|183099817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0255|TWO_SIDED|95.0|-0.41|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.03|-0.41|0.0255
91523086|NCT01337986|182921666|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91523087|NCT01337986|182921667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Regression, Linear|||||||0.72
91523088|NCT02313909|182921669|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.51884|TWO_SIDED|95.0|0.87|1.33|||Log Rank|||Statistical analysis: Stroke + Systemic embolism: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.33|0.87|0.51884
91603477|NCT01360645|183099817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0005|TWO_SIDED|95.0|-0.57|-0.16|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.16|-0.57|0.0005
91603478|NCT01360645|183099817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.62|0.0001
91603479|NCT01360645|183099817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0005|TWO_SIDED|95.0|-0.6|-0.17|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.17|-0.60|0.0005
91603480|NCT01360645|183099818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.10|-0.40|0.0010
91603481|NCT01360645|183099818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.029|TWO_SIDED|95.0|-0.37|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.02|-0.37|0.0290
91603482|NCT01360645|183099818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0422|TWO_SIDED|95.0|-0.4|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.01|-0.40|0.0422
91603483|NCT01360645|183099818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0003|TWO_SIDED|95.0|-0.61|-0.18|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.18|-0.61|0.0003
91603484|NCT01360645|183099818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0002|TWO_SIDED|95.0|-0.64|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.64|0.0002
91603485|NCT01360645|183099818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.19|-0.65|0.0003
91603486|NCT01360645|183099819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0229|TWO_SIDED|95.0|-0.25|-0.02|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.02|-0.25|0.0229
91603487|NCT01360645|183099819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0459|TWO_SIDED|95.0|-0.28|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.00|-0.28|0.0459
91603488|NCT01360645|183099819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0097|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-0.05|-0.37|0.0097
91603489|NCT01360645|183099819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0038|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.08|-0.42|0.0038
91787524|NCT03137069|183454559|SUPERIORITY||Least Squares Mean Difference|-9.53||||0.0097|TWO_SIDED|90.0|-15.5|-3.55|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-3.55|-15.50|0.0097
91603490|NCT01360645|183099819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0001|TWO_SIDED|95.0|-0.54|-0.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.18|-0.54|0.0001
91603491|NCT01360645|183099819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0004|TWO_SIDED|95.0|-0.52|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14.||-0.15|-0.52|0.0004
91603492|NCT01360645|183099820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0109|TWO_SIDED|95.0|-0.27|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.04|-0.27|0.0109
91603493|NCT01360645|183099820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1286|TWO_SIDED|95.0|-0.25|0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.03|-0.25|0.1286
91603494|NCT01360645|183099820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0521|TWO_SIDED|95.0|-0.32|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.00|-0.32|0.0521
91603495|NCT01360645|183099820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0084|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.06|-0.42|0.0084
91603496|NCT01360645|183099820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.16|-0.54|0.0003
91787525|NCT03137069|183454560|SUPERIORITY|||||||0.1087|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.1087
91787526|NCT03137069|183454560|SUPERIORITY|||||||0.3418|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.3418
91787527|NCT03137069|183454560|SUPERIORITY|||||||0.0459|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0459
91787528|NCT03137069|183454560|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0190
91787529|NCT03137069|183454561|SUPERIORITY||Least Squares Mean Difference|-12.88||||0.001|TWO_SIDED|90.0|-18.94|-6.82|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-6.82|-18.94|0.0010
91603497|NCT01360645|183099820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0006|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.15|-0.53|0.0006
91603498|NCT01360645|183099821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0139|TWO_SIDED|95.0|-2.82|-0.32|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.32|-2.82|0.0139
91603499|NCT01360645|183099821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0436|TWO_SIDED|95.0|-3.01|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.04|-3.01|0.0436
91603500|NCT01360645|183099821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.1903|TWO_SIDED|95.0|-2.75|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.55|-2.75|0.1903
91603501|NCT01360645|183099821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47||||0.0951|TWO_SIDED|95.0|-3.21|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.26|-3.21|0.0951
91603502|NCT01360645|183099821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0626|TWO_SIDED|95.0|-3.59|0.09|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.09|-3.59|0.0626
91603503|NCT01360645|183099821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96||||0.0435|TWO_SIDED|95.0|-3.87|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.06|-3.87|0.0435
91603504|NCT01360645|183099822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0069|TWO_SIDED|95.0|-2.95|-0.47|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.47|-2.95|0.0069
91603505|NCT01360645|183099822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.1322|TWO_SIDED|95.0|-2.68|0.35|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.35|-2.68|0.1322
91603506|NCT01360645|183099822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.4055|TWO_SIDED|95.0|-2.41|0.98|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.98|-2.41|0.4055
91603507|NCT01360645|183099822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.1715|TWO_SIDED|95.0|-3.08|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.55|-3.08|0.1715
91603508|NCT01360645|183099822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.1424|TWO_SIDED|95.0|-3.33|0.48|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.48|-3.33|0.1424
91603509|NCT01360645|183099822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.127|TWO_SIDED|95.0|-3.52|0.44|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||0.44|-3.52|0.1270
91603510|NCT01360645|183099823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3079|TWO_SIDED|95.0|-0.81|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||0.26|-0.81|0.3079
91650660|NCT00433381|183194145|OTHER|||||||||||||||||Null hypothesis: 35% discontinuation rate of bevacizumab and temozolomide. Alternative hypothesis: 5%. Type I and II error rates = 0.10. Sample size = 29.|The determination of treatment tolerability was to be made based on the following rules: If 6 or fewer of the cases (6/29=20.6%) stop treatment due to medical conditions, then reject the null hypothesis that the discontinuation rate is at least 35% and conclude tolerability. If 7 or more of the cases (7/29=24.1%) stop treatment due to medical conditions, then reject the alternative hypothesis that the discontinuation rate no more than 15%.|||
91603511|NCT01360645|183099823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4771|TWO_SIDED|95.0|-0.73|0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 14||0.34|-0.73|0.4771
91603512|NCT01360645|183099823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0195|TWO_SIDED|95.0|-0.92|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 11||-0.08|-0.92|0.0195
91603513|NCT01360645|183099823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0323|TWO_SIDED|95.0|-0.96|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 14||-0.04|-0.96|0.0323
91603514|NCT01360645|183099823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0058|TWO_SIDED|95.0|-1.07|-0.18|||Cochran-Mantel-Haenszel|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 11||-0.18|-1.07|0.0058
91603515|NCT01360645|183099823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0129|TWO_SIDED|95.0|-1.07|-0.13|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 14||-0.13|-1.07|0.0129
91603516|NCT01360645|183099824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.5151|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 11||0.36|-0.71|0.5151
91603517|NCT01360645|183099824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.608|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 14||0.41|-0.70|0.6080
91603518|NCT01360645|183099824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0267|TWO_SIDED|95.0|-0.92|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 11||-0.06|-0.92|0.0267
91603519|NCT01360645|183099824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0224|TWO_SIDED|95.0|-1.01|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 14||-0.08|-1.01|0.0224
91603520|NCT01360645|183099824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0146|TWO_SIDED|95.0|-1.01|-0.11|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 11||-0.11|-1.01|0.0146
91603521|NCT01360645|183099824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0113|TWO_SIDED|95.0|-1.09|-0.14|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 14||-0.14|-1.09|0.0113
91603522|NCT01360645|183099825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.0001|TWO_SIDED|95.0|-3.47|-1.22|||ANCOVA|||ANCOVA\_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-1.22|-3.47|0.0001
91603523|NCT01360645|183099826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0002|TWO_SIDED|95.0|-3.47|-1.12|||ANCOVA|||||-1.12|-3.47|0.0002
91603524|NCT01360645|183099827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0219|TWO_SIDED|95.0|-2.17|-0.17|||ANCOVA|||ANCOVA\_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-0.17|-2.17|0.0219
91603525|NCT01360645|183099828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0376|TWO_SIDED|95.0|-2.13|-0.06|||ANCOVA|||||-0.06|-2.13|0.0376
91603526|NCT01360645|183099829|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.63||||0.0176|TWO_SIDED|95.0|1.09|2.44|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.44|1.09|0.0176
91603527|NCT01360645|183099830|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.54||||0.0429|TWO_SIDED|95.0|1.01|2.35|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.35|1.01|0.0429
91603528|NCT01360645|183099831|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.68||||0.0586|TWO_SIDED|95.0|0.98|2.86|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.86|0.98|0.0586
91603529|NCT01360645|183099832|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0671|TWO_SIDED|95.0|0.97|2.9|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.90|0.97|0.0671
91603530|NCT01360645|183099833|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.61||||0.0003|TWO_SIDED|95.0|1.23|2.1|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.10|1.23|0.0003
91603531|NCT01360645|183099834|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.69||||0.0002|TWO_SIDED|95.0|1.27|2.27|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.27|1.27|0.0002
91787530|NCT03137069|183454561|SUPERIORITY||Least Squares Mean Difference|-2.83||||0.4565|TWO_SIDED|90.0|-9.11|3.46|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||3.46|-9.11|0.4565
91603532|NCT00754156|183099880|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91603533|NCT00348140|183099901|SUPERIORITY||Mean Difference (Net)|0.3||||0.739|TWO_SIDED|95.0|-1.2|1.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.8|-1.2|0.739
91603534|NCT00348140|183099901|SUPERIORITY||Mean Difference (Net)|0.8||||0.343|TWO_SIDED|95.0|-0.8|2.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||2.4|-0.8|0.343
91603535|NCT00348140|183099902|SUPERIORITY||Mean Difference (Net)|-0.1||||0.783|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|0.783
91603536|NCT00348140|183099902|SUPERIORITY||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-1.1|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.1|-1.1|0.940
91603537|NCT00348140|183099903|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.763|TWO_SIDED|95.0|-1.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.8|-1.1|=0.763
91603538|NCT00348140|183099903|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.8|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|=0.800
91603539|NCT00348140|183099904|SUPERIORITY||Mean Difference (Net)|-0.1||||0.611|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.7|0.611
91787531|NCT03137069|183454561|SUPERIORITY||Least Squares Mean Difference|-5.03||||0.1711|TWO_SIDED|90.0|-11.1|1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||1.03|-11.10|0.1711
91787532|NCT03137069|183454561|SUPERIORITY||Least Squares Mean Difference|-10.76||||0.005|TWO_SIDED|90.0|-16.97|-4.56|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-4.56|-16.97|0.0050
91603540|NCT00348140|183099904|SUPERIORITY||Mean Difference (Net)|-0.1||||0.741|TWO_SIDED|95.0|-0.6|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.6|0.741
91603541|NCT00348140|183099905|SUPERIORITY||Mean Difference (Net)|0.0||||0.913|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.3|-0.4|0.913
91603542|NCT00348140|183099905|SUPERIORITY||Mean Difference (Net)|-0.1||||0.481|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.481
91603543|NCT00348140|183099906|SUPERIORITY||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.4|0.557
91603544|NCT00348140|183099906|SUPERIORITY||Mean Difference (Net)|-0.1||||0.404|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.404
91603545|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.1||||0.633|TWO_SIDED|95.0|-0.5|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.5|0.633
91603546|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.2||||0.575|TWO_SIDED|95.0|-0.4|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.4|0.575
91603547|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.1||||0.82|TWO_SIDED|95.0|-0.6|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-0.6|0.820
91603548|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.0||||0.908|TWO_SIDED|95.0|-0.7|0.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.6|-0.7|0.908
91603549|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.1|-0.3|0.292
91603550|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.0||||0.978|TWO_SIDED|95.0|-0.7|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.7|0.978
91650661|NCT00433381|183194146|OTHER|Receiver Operating Characteristic (ROC) analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.09|0.91||||||Accuracy estimate, as measured by the Area under the Curve (AUC), for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.91|0.09|
91790604|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91603551|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|0.2||||0.691|TWO_SIDED|95.0|-0.6|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||1.0|-0.6|0.691
91603552|NCT00348140|183099907|SUPERIORITY||Mean Difference (Net)|-0.1||||0.849|TWO_SIDED|95.0|-0.9|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.8|-0.9|0.849
91650662|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.14|0.95||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.95|0.14|
91650663|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|0.99||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 2 weeks||0.99|0|
91790605|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.226|TWO_SIDED|95.0|-0.301|0.071||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.071|-0.301|0.226
91790606|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790607|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.093||0.683|TWO_SIDED|95.0|-0.222|0.145||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.145|-0.222|0.683
91603553|NCT00348140|183099908|SUPERIORITY||Mean Difference (Net)|0.0||||0.938|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.938
91603554|NCT00348140|183099908|SUPERIORITY||Mean Difference (Net)|0.0||||0.887|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.887
91603555|NCT00348140|183099908|SUPERIORITY||Mean Difference (Net)|-0.1||||0.465|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.2|-0.4|0.465
91603556|NCT00348140|183099908|SUPERIORITY||Mean Difference (Net)|0.1||||0.596|TWO_SIDED|95.0|-0.2|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.3|-0.2|0.596
91603557|NCT00348140|183099908|SUPERIORITY||Mean Difference (Net)|-0.1||||0.452|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.452
91603558|NCT00348140|183099908|SUPERIORITY||Mean Difference (Net)|-0.1||||0.429|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.429
91603559|NCT00348140|183099909|SUPERIORITY||Mean Difference (Net)|-0.3||||0.386|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.386
91603560|NCT00348140|183099909|SUPERIORITY||Mean Difference (Net)|0.0||||0.999|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.999
91603561|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|1.1||||0.09|TWO_SIDED|95.0|-0.2|2.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||2.5|-0.2|0.090
91603562|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.3|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||1.3|-1.3|0.957
91603563|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|0.7||||0.395|TWO_SIDED|95.0|-0.9|2.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||2.2|-0.9|0.395
91603564|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|-0.9||||0.275|TWO_SIDED|95.0|-2.5|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-2.5|0.275
91650664|NCT00433381|183194146|OTHER||Area Under the Curve (AUC)|0.85|||||TWO_SIDED|95.0|0.53|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.53|
91650665|NCT00433381|183194146|OTHER||Area Under the Curve (AUC)|0.83|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.47|
91650666|NCT00433381|183194146|OTHER||Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.11|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.11|
91650667|NCT00433381|183194146|OTHER||Area Under the Curve (AUC)|0.75|||||TWO_SIDED|95.0|0.21|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.21|
91603565|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|1.7||||0.039|TWO_SIDED|95.0|0.1|3.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||3.4|0.1|0.039
91603566|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|-0.1||||0.895|TWO_SIDED|95.0|-1.8|1.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.6|-1.8|0.895
91650668|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|1|
91650669|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0|
91650670|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.39|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 2 weeks||0.88|0|
91650671|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.52|||||TWO_SIDED|95.0|0.13|0.91||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 2 weeks||0.91|0.13|
91650672|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.06|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 2 weeks||1|0.06|
91650673|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.47|||||TWO_SIDED|95.0|0.02|0.92||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.92|0.02|
91650674|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.41|||||TWO_SIDED|95.0|0.01|0.8||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.80|0.01|
91650675|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.63|||||TWO_SIDED|95.0|0.22|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.22|
91650676|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
91523089|NCT02313909|182921670|SUPERIORITY||Hazard Ratio (HR)|2.72||||2e-05|TWO_SIDED|95.0|1.68|4.39|||Log Rank|||Statistical analysis: ISTH major bleeding events: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.39|1.68|0.00002
91650677|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|1|
91603567|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|0.1||||0.914|TWO_SIDED|95.0|-2.1|2.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||2.3|-2.1|0.914
91603568|NCT00348140|183099910|SUPERIORITY||Mean Difference (Net)|-0.9||||0.43|TWO_SIDED|95.0|-3.2|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||1.3|-3.2|0.430
91603569|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|-0.2||||0.583|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.583
91603570|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.631
91603571|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|0.1||||0.812|TWO_SIDED|95.0|-0.8|1.1|||Mixed model for repeated measures|||For Week 16||1.1|-0.8|0.812
91603572|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|0.0||||0.952|TWO_SIDED|95.0|-0.9|1.0|||Mixed model for repeated measures|||For Week 16||1.0|-0.9|0.952
91603573|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|-0.9||||0.117|TWO_SIDED|95.0|-2.1|0.2|||Mixed model for repeated measures|||For Week 24||0.2|-2.1|0.117
91603574|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|-1.0||||0.074|TWO_SIDED|95.0|-2.1|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.1|-2.1|0.074
91603575|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|-1.0||||0.141|TWO_SIDED|95.0|-2.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.3|-2.4|0.141
91603576|NCT00348140|183099911|SUPERIORITY||Mean Difference (Net)|-0.7||||0.331|TWO_SIDED|95.0|-2.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.7|-2.1|0.331
91603577|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|4.1||||0.251|TWO_SIDED|95.0|-2.9|11.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||11.2|-2.9|0.251
91603578|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|5.9||||0.113|TWO_SIDED|95.0|-1.4|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||13.2|-1.4|0.113
91650678|NCT00433381|183194146|OTHER|ROC analysis|Area Under the Curve (AUC)|0.93|||||TWO_SIDED|95.0|0.73|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|0.73|
91603579|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|1.6||||0.723|TWO_SIDED|95.0|-7.1|10.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||10.2|-7.1|0.723
91603580|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|3.5||||0.482|TWO_SIDED|95.0|-6.3|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||13.2|-6.3|0.482
91603581|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|1.5||||0.785|TWO_SIDED|95.0|-9.5|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||12.6|-9.5|0.785
91603582|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|2.2||||0.711|TWO_SIDED|95.0|-9.4|13.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||13.8|-9.4|0.711
91603583|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|4.0||||0.484|TWO_SIDED|95.0|-7.2|15.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.2|-7.2|0.484
91603584|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|3.4||||0.572|TWO_SIDED|95.0|-8.5|15.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.4|-8.5|0.572
91603585|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|6.8||||0.197|TWO_SIDED|95.0|-3.6|17.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||17.3|-3.6|0.197
91603586|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|7.4||||0.183|TWO_SIDED|95.0|-3.5|18.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||18.4|-3.5|0.183
91603587|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|10.0||||0.121|TWO_SIDED|95.0|-2.6|22.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||22.6|-2.6|0.121
91603588|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|6.8||||0.291|TWO_SIDED|95.0|-5.8|19.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||19.3|-5.8|0.291
91603589|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|7.0||||0.389|TWO_SIDED|95.0|-8.9|22.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||22.9|-8.9|0.389
91650679|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.92||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.92|0|
91603590|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|-1.2||||0.865|TWO_SIDED|95.0|-15.0|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||12.6|-15.0|0.865
91603591|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|4.2||||0.596|TWO_SIDED|95.0|-11.3|19.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||19.6|-11.3|0.596
91603592|NCT00348140|183099912|SUPERIORITY||Mean Difference (Net)|-0.2||||0.975|TWO_SIDED|95.0|-14.7|14.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||14.2|-14.7|0.975
91603593|NCT00348140|183099913|SUPERIORITY||Mean Difference (Net)|-2.4||||0.043|TWO_SIDED|95.0|-4.7|-0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||-0.1|-4.7|0.043
91603594|NCT00348140|183099913|SUPERIORITY||Mean Difference (Net)|-2.2||||0.056|TWO_SIDED|95.0|-4.5|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||0.1|-4.5|0.056
91603595|NCT00348140|183099913|SUPERIORITY||Mean Difference (Net)|-0.4||||0.758|TWO_SIDED|95.0|-2.8|2.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||2.1|-2.8|0.758
91603596|NCT00348140|183099913|SUPERIORITY||Mean Difference (Net)|-2.0||||0.109|TWO_SIDED|95.0|-4.5|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||0.5|-4.5|0.109
91790608|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91603597|NCT00348140|183099913|SUPERIORITY||Mean Difference (Net)|-2.6||||0.05|TWO_SIDED|95.0|-5.2|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.0|-5.2|0.050
91603598|NCT00348140|183099913|SUPERIORITY||Mean Difference (Net)|-3.4||||0.009|TWO_SIDED|95.0|-6.0|-0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.9|-6.0|0.009
91603599|NCT00348140|183099914|SUPERIORITY||Mean Difference (Net)|0.01||||0.662|TWO_SIDED|95.0|-0.02|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.03|-0.02|0.662
91603600|NCT00348140|183099914|SUPERIORITY||Mean Difference (Net)|-0.01||||0.503|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.02|-0.03|0.503
91650680|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.88|0|
91790609|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.094||0.848|TWO_SIDED|95.0|-0.168|0.204||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.204|-0.168|0.848
91790610|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790611|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.656|TWO_SIDED|95.0|-0.305|0.192||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.192|-0.305|0.656
91790612|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790613|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.124||0.777|TWO_SIDED|95.0|-0.279|0.209||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.209|-0.279|0.777
91790614|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523090|NCT02313909|182921671|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.56922|TWO_SIDED|95.0|0.87|1.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.87|0.56922
91603601|NCT00348140|183099914|SUPERIORITY||Mean Difference (Net)|0.0||||0.892|TWO_SIDED|95.0|-0.03|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.03|-0.03|0.892
91603602|NCT00348140|183099914|SUPERIORITY||Mean Difference (Net)|-0.03||||0.083|TWO_SIDED|95.0|-0.05|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.00|-0.05|0.083
91603603|NCT00348140|183099914|SUPERIORITY||Mean Difference (Net)|-0.01||||0.366|TWO_SIDED|95.0|-0.05|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.05|0.366
91603604|NCT00348140|183099914|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.03|0.769
91603605|NCT00348140|183099915|SUPERIORITY||Mean Difference (Net)|-0.2||||0.529|TWO_SIDED|95.0|-0.7|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.3|-0.7|0.529
91603606|NCT00348140|183099915|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.4|-0.7|0.620
91603607|NCT00348140|183099915|SUPERIORITY||Mean Difference (Net)|-0.4||||0.284|TWO_SIDED|95.0|-1.0|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.3|-1.0|0.284
91603608|NCT00348140|183099915|SUPERIORITY||Mean Difference (Net)|0.2||||0.488|TWO_SIDED|95.0|-0.4|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.9|-0.4|0.488
91603609|NCT00348140|183099915|SUPERIORITY||Mean Difference (Net)|0.2||||0.549|TWO_SIDED|95.0|-0.5|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 48||1.0|-0.5|0.549
91603610|NCT00348140|183099915|SUPERIORITY||Mean Difference (Net)|0.1||||0.78|TWO_SIDED|95.0|-0.6|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.9|-0.6|0.780
91603611|NCT00348140|183099916|SUPERIORITY||Mean Difference (Net)|-0.6||||0.106|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.106
91603612|NCT00348140|183099916|SUPERIORITY||Mean Difference (Net)|-0.4||||0.229|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||||0.3|-1.2|0.229
91603613|NCT00348140|183099917|SUPERIORITY||Mean Difference (Net)|-0.1||||0.324|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.324
91603614|NCT00348140|183099917|SUPERIORITY||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.987
91603615|NCT00348140|183099918|SUPERIORITY||Mean Difference (Net)|0.05||||0.038|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.10|0.00|0.038
91603616|NCT00348140|183099918|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||ANCOVA|||||0.18|0.08|<0.001
91650681|NCT00433381|183194147|OTHER|ROC analysis|Accuracy: Area Under the ROC|0.67|||||TWO_SIDED|95.0|0.25|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 2 weeks||1|0.25|
91603617|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|-0.1||||0.748|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.3|-0.4|0.748
91787533|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
91787534|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||6.94|-3.53|
91603618|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.1||||0.617|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.5|-0.3|0.617
91603619|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|-0.1||||0.708|TWO_SIDED|95.0|-0.5|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.3|-0.5|0.708
91603620|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.2|-0.5|0.400
91603621|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.0||||0.928|TWO_SIDED|95.0|-0.4|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.4|-0.4|0.928
91603622|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.3||||0.178|TWO_SIDED|95.0|-0.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.1|0.178
91650682|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.47|
91650683|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.44|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.44|
91603623|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.1||||0.626|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.626
91650684|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.17|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.17|
91650685|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.45|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.45|
91790615|NCT02880956|183460071|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.128||0.256|TWO_SIDED|95.0|-0.106|0.397||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.397|-0.106|0.256
91523091|NCT02313909|182921672|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.22078|TWO_SIDED|95.0|0.87|1.81|||Log Rank|||Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.81|0.87|0.22078
91790616|NCT02880956|183460071|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523092|NCT02313909|182921673|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4797|TWO_SIDED|95.0|0.87|1.34|||Log Rank|||Statistical analysis 1: Stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.34|0.87|0.47970
91523093|NCT02313909|182921673|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.78738|TWO_SIDED|95.0|0.83|1.29|||Log Rank|||Statistical analysis 2: Ischemic stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.83|0.78738
91523094|NCT02313909|182921673|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.14822|TWO_SIDED|95.0|0.88|2.28|||Log Rank|||Statistical analysis 3: Disabling stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.28|0.88|0.14822
91523095|NCT02313909|182921673|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.14051|TWO_SIDED|95.0|0.87|2.52|||Log Rank|||Statistical analysis 4:CV death: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.52|0.87|0.14051
91603624|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.1||||0.608|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.608
91603625|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.0||||0.865|TWO_SIDED|95.0|-0.5|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.4|-0.5|0.865
91603626|NCT00348140|183099931|SUPERIORITY||Mean Difference (Net)|0.3||||0.149|TWO_SIDED|95.0|-0.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.8|-0.1|0.149
91650686|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.73|||||TWO_SIDED|95.0|0.19|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|0.19|
91603627|NCT00868790|183099932|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|-17.2||||0.013|TWO_SIDED|90.0|-28.3|-6.1|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-6.1|-28.3|0.013
91603628|NCT00868790|183099932|SUPERIORITY_OR_OTHER||LSM Difference|-23.4|||<|0.001|TWO_SIDED|90.0|-34.5|-12.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-12.4|-34.5|<0.001
91603629|NCT00868790|183099932|SUPERIORITY_OR_OTHER||LSM Difference|-34.9|||<|0.001|TWO_SIDED|95.0|-44.8|-25.0|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-25.0|-44.8|<0.001
91603630|NCT00868790|183099933|SUPERIORITY_OR_OTHER||LSM Difference|-11.5||||0.002|TWO_SIDED|90.0|-17.5|-5.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-5.4|-17.5|0.002
91603631|NCT00868790|183099933|SUPERIORITY_OR_OTHER||LSM Difference|-21.8|||<|0.001|TWO_SIDED|90.0|-27.8|-15.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-15.8|-27.8|<0.001
91603632|NCT00868790|183099933|SUPERIORITY_OR_OTHER||LSM Difference|-36.0|||<|0.001|TWO_SIDED|90.0|-42.0|-30.0|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-30.0|-42.0|<0.001
91603633|NCT00868790|183099933|SUPERIORITY_OR_OTHER||LSM Difference|-20.0||||0.001|TWO_SIDED|90.0|-30.0|-10.1|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-10.1|-30.0|0.001
91603634|NCT00868790|183099934|SUPERIORITY_OR_OTHER||LSM Difference|-14.9||||0.174|TWO_SIDED|90.0|-33.0|3.2|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||3.2|-33.0|0.174
91603635|NCT00868790|183099934|SUPERIORITY_OR_OTHER||LSM Difference|-20.4||||0.063|TWO_SIDED|90.0|-38.4|-2.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-2.4|-38.4|0.063
91603636|NCT00868790|183099934|SUPERIORITY_OR_OTHER||LSM Difference|-78.1|||<|0.001|TWO_SIDED|90.0|-96.4|-59.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-59.8|-96.4|<0.001
91603637|NCT00868790|183099934|SUPERIORITY_OR_OTHER||LSM Difference|-49.4|||<|0.001|TWO_SIDED|90.0|-66.9|-31.8|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-31.8|-66.9|<0.001
91603638|NCT00868790|183099935|SUPERIORITY_OR_OTHER||LSM Difference|-0.8||||0.742|TWO_SIDED|90.0|-4.6|3.1|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||3.1|-4.6|0.742
91650687|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.57|||||TWO_SIDED|95.0|0.03|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0.03|
91650688|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.2|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 2 weeks||1|0.20|
91650689|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.36|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 2 weeks||1|0.36|
91650690|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.06|0.94||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 2 weeks||0.94|0.06|
91603639|NCT00868790|183099935|SUPERIORITY_OR_OTHER||LSM Difference|4.5||||0.06|TWO_SIDED|90.0|0.6|8.4|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||8.4|0.6|0.060
91603640|NCT00868790|183099935|SUPERIORITY_OR_OTHER||LSM Difference|7.8||||0.002|TWO_SIDED|90.0|3.8|11.7|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||11.7|3.8|0.002
91603641|NCT00868790|183099935|SUPERIORITY_OR_OTHER||LSM Difference|-3.9||||0.248|TWO_SIDED|90.0|-10.2|2.3|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||2.3|-10.2|0.248
91603642|NCT04666038|183099948|SUPERIORITY||Hazard Ratio (HR)|0.536||||0.0002|TWO_SIDED|95.0|0.385|0.746||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The Hazard Ratio (HR) \& 95% confidence interval (CI) were estimated from a stratified Cox proportional hazards model.|||0.746|0.385|0.0002
91523096|NCT02313909|182921673|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.34284|TWO_SIDED|95.0|0.39|1.38|||Log Rank|||Statistical analysis 5: Myocardial infarction: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.38|0.39|0.34284
91523097|NCT02313909|182921674|SUPERIORITY||Hazard Ratio (HR)|2.34||||0.00443|TWO_SIDED|95.0|1.28|4.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.29|1.28|0.00443
91603643|NCT04666038|183099949|SUPERIORITY||Hazard Ratio (HR)|0.475|||<|0.0001|TWO_SIDED|95.0|0.338|0.669||The 2-sided nominal p-value was calculated based on a stratified log-rank test|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.669|0.338|<0.0001
91603644|NCT04666038|183099950|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7202|TWO_SIDED|95.0|0.679|1.749||The 2-sided p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||1.749|0.679|0.7202
91603645|NCT04666038|183099951|SUPERIORITY||Hazard Ratio (HR)|0.365|||<|0.0001|TWO_SIDED|95.0|0.254|0.524||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.524|0.254|<0.0001
91603646|NCT04666038|183099952|SUPERIORITY||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.28|0.534||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.534|0.280|<0.0001
91603647|NCT01228903|183099967|EQUIVALENCE|(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.|Mean Difference (Net)|0.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The estimated value represents the difference between the change from baseline in both groups.|The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.||||0.47
91603648|NCT02867761|183099973|SUPERIORITY||Odds Ratio (OR)|0.91||||0.65|TWO_SIDED|95.0|0.6|1.37|||Generalized Estimating Equation|||||1.37|0.60|0.65
91603649|NCT02867761|183099977|SUPERIORITY|||||||0.3|||||||Linear Mixed Effects Model|||||||0.30
91603650|NCT02867761|183099978|SUPERIORITY|||||||0.49|||||||Linear Mixed Effects Model|||||||0.49
91603651|NCT02867761|183099979|SUPERIORITY|||||||0.96|||||||Linear Mixed Effects Model|||||||0.96
91603652|NCT02867761|183099980|SUPERIORITY||||||<|0.001|||||||Linear Mixed Effects Model|||||||<0.001
91650691|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.58|||||TWO_SIDED|95.0|0.22|0.95||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.95|0.22|
91603653|NCT02867761|183099983|SUPERIORITY|||||||0.35|||||||Linear Mixed Effects Model|||P Value for percentage of days with any symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum)||||0.35
91603654|NCT02867761|183099983|SUPERIORITY|||||||0.61|||||||Linear Mixed Effects Model|||P Value for percentage of days with shortness of breath||||0.61
91603655|NCT02867761|183099983|SUPERIORITY|||||||0.48|||||||Linear Mixed Effects Model|||P Value for percentage of days with chest tightness||||0.48
91603656|NCT02867761|183099983|SUPERIORITY|||||||0.81|||||||Linear Mixed Effects Model|||P Value for percentage of days with wheezing||||0.81
91603657|NCT02867761|183099983|SUPERIORITY|||||||0.17|||||||Linear Mixed Effects Model|||P Value for percentage of days with cough||||0.17
91603658|NCT02867761|183099983|SUPERIORITY|||||||0.64|||||||Linear Mixed Effects Model|||P Value for percentage of days with sputum||||0.64
91603659|NCT02867761|183099983|SUPERIORITY|||||||0.84|||||||Linear Mixed Effects Model|||P Value for percentage of days with use of albuterol.||||0.84
91650692|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.13|0.87||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.87|0.13|
91650693|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.47|
91650694|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
91790617|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.479|TWO_SIDED|95.0|-0.269|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.269|0.479
91603660|NCT00896532|183100009|SUPERIORITY||LS Mean Difference from Placebo|8.7|||<|0.0001|TWO_SIDED|95.0|7.5|9.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.9|7.5|< 0.0001
91603661|NCT00896532|183100009|SUPERIORITY||LS Mean Difference from placebo|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||6.9|4.3|< 0.0001
91603662|NCT00896532|183100009|SUPERIORITY||LS Mean Difference from Placebo|7.4|||<|0.0001|TWO_SIDED|95.0|6.1|8.7||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||8.7|6.1|< 0.0001
91603663|NCT00896532|183100009|SUPERIORITY||LS Mean Difference from Placebo|8.5|||<|0.0001|TWO_SIDED|95.0|7.3|9.8||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.8|7.3|< 0.0001
91603664|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.77||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 16||0.77|0.63|< 0.001
91603665|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.8||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 18||0.80|0.64|< 0.001
91603666|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.6|0.74||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 31||0.74|0.60|< 0.001
91603667|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 33||0.80|0.67|< 0.001
91650695|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.63|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|0.63|
91790618|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91603668|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 45||0.76|0.60|< 0.001
91603669|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.78||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 52||0.78|0.64|< 0.001
91650696|NCT00433381|183194147|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|1|
91650697|NCT00433381|183194148|OTHER||||||||||||||||||The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
91650698|NCT00433381|183194150|OTHER|Agreement was assessed using a Kappa statistic|Kappa Statistic|0.39|||||TWO_SIDED|95.0|0.21|0.57||||||Agreement between Local and Central determinations 6-month PFS, based on imaging, was evaluated using Kappa statistics||0.57|0.21|
91650699|NCT00433381|183194151|OTHER|Sensitivity|Sensitivity|0.6|||||TWO_SIDED|95.0|0.46|0.73||||||Sensitivity||0.73|0.46|
91787535|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
91787536|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.78||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.78|-4.78|
91787537|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
91787538|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
91790619|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.295|TWO_SIDED|95.0|-0.299|0.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.091|-0.299|0.295
91790620|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790621|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.102||0.884|TWO_SIDED|95.0|-0.186|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.215|-0.186|0.884
91650700|NCT00433381|183194151|OTHER|Specificity|Specificity|0.78|||||TWO_SIDED|95.0|0.66|0.87||||||Specificity||0.87|0.66|
91650701|NCT01387282|183194158|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
91650702|NCT01387282|183194159|SUPERIORITY_OR_OTHER|||||||0.648|||||||Wilcoxon rank sum test|||Superiority analysis||||0.6480
91650703|NCT01387282|183194160|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Mixed Models Analysis|||Superiority analysis||||0.0016
91650704|NCT01387282|183194161|SUPERIORITY_OR_OTHER|||||||0.8637|||||||Mixed Models Analysis|||Superiority analysis||||0.8637
91650705|NCT01387282|183194162|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
91650706|NCT01034137|183194201|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.996|||<|0.001|TWO_SIDED|95.0|1.589|2.506|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the Cochran-Mantel-Haenszel (CMH) test taking into account the stratification factors used for randomization.||2.506|1.589|< 0.001
91650707|NCT01034137|183194201|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.855|||<|0.001|TWO_SIDED|95.0|1.481|2.323|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||2.323|1.481|< 0.001
91650708|NCT01034137|183194201|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.616|TWO_SIDED|95.0|0.915|1.16|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||1.160|0.915|0.616
91650709|NCT01381900|183194250|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.644|-0.367|||ANCOVA|||||-0.367|-0.644|<0.001
91650710|NCT01381900|183194250|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.731|-0.453|||ANCOVA|||||-0.453|-0.731|<0.001
91650711|NCT01381900|183194251|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.375|-0.694|||ANCOVA|||||-0.694|-1.375|<0.001
91650712|NCT01381900|183194251|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.769|-1.089|||ANCOVA|||||-1.089|-1.769|<0.001
91650713|NCT01381900|183194252|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.7|-1.6|||ANCOVA|||||-1.6|-2.7|<0.001
91603670|NCT03158220|183100030|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 58||0.76|0.63|< 0.001
91603671|NCT03158220|183100033|OTHER||Difference in Percentages|-2.5||||0.212|TWO_SIDED|95.0|-6.4|1.4|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||1.4|-6.4|0.212
91603672|NCT03158220|183100034|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.3|3.4|||||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||3.4|-7.3|
91603673|NCT03158220|183100035|OTHER||Difference in Percentages|-1.0||||0.3|TWO_SIDED|95.0|-3.1|0.9|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||0.9|-3.1|0.300
91603674|NCT02525549|183100037|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|93.12|||||TWO_SIDED|90.0|88.6|102.0|||Fieller's method|||||102.00|88.6|
91603675|NCT02525549|183100038|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|98.7|||||TWO_SIDED|90.0|92.3|109.4|||Fieller's method|||||109.4|92.3|
91603676|NCT02238847|183100047|NON_INFERIORITY|The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.|||||<|0.01||||||Reported p-value of \<0.01 is calculated p-value. (p\<0.05 was considered significant)|Exact Non-inferiority|||||||<0.01
91603677|NCT02238847|183100048|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
91650714|NCT01381900|183194252|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.8|||ANCOVA|||||-1.8|-2.9|<0.001
91650715|NCT01381900|183194253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||||TWO_SIDED|95.0|2.09|5.09|||Regression, Logistic|||||5.09|2.09|
91603678|NCT01439945|183100078|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.13
91603679|NCT01439945|183100078|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.67
91603680|NCT01439945|183100079|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|Weekly number of hot flashes were treated as a repeated measure for each patient.||||||0.25
91650716|NCT01381900|183194253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||||TWO_SIDED|95.0|2.55|6.27|||Regression, Logistic|||||6.27|2.55|
91790622|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91603681|NCT01439945|183100079|SUPERIORITY_OR_OTHER|||||||0.55||||||Weekly number of hot flashes were treated as a repeated measure for each patient.|ANOVA|||||||0.55
91603682|NCT01439945|183100082|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91603683|NCT01439945|183100083|SUPERIORITY_OR_OTHER|||||||0.47|||||||Kruskal-Wallis|||||||0.47
91603684|NCT01439945|183100083|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
91603685|NCT00654498|183100104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.52|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-6.58|-2.46|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-2.46|-6.58|<0.0001
91603686|NCT00654498|183100105|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
91603687|NCT00654498|183100106|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
91603688|NCT00654498|183100107|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
91603689|NCT00654498|183100108|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||Chi-squared|||||||0.1386
91603690|NCT00654498|183100109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.14|-0.83|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.83|-2.14|<0.0001
91603691|NCT00654498|183100110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.99|-0.73|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.73|-1.99|<0.0001
91603692|NCT00654498|183100111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.0|-0.72|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.72|-2.00|<0.0001
91603693|NCT00654498|183100112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0402|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.02|-1.06|0.0402
91603694|NCT00654498|183100113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0771|TWO_SIDED|95.0|-0.69|0.04|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||0.04|-0.69|0.0771
91603695|NCT00654498|183100114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.0048|TWO_SIDED|95.0|-1.2|-0.22|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.22|-1.20|0.0048
91603696|NCT00654498|183100115|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||||<0.0001
91650717|NCT01381900|183194254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.45|4.48|||Regression, Logistic|||||4.48|1.45|
91650718|NCT01381900|183194254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||||TWO_SIDED|95.0|1.88|5.75|||Regression, Logistic|||||5.75|1.88|
91790623|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.569|TWO_SIDED|95.0|-0.281|0.155||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.155|-0.281|0.569
91790624|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91787539|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
91613699|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.85||||0.17|TWO_SIDED|95.0|0.67|1.07||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating of implant||1.07|0.67|0.17
91709544|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.2603|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.249|-0.068|0.2603
91603697|NCT00484315|183100123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.|Median Difference (Final Values)|-0.57|STANDARD_DEVIATION|0.0155||0.9996|ONE_SIDED|95.0||1.85||The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data observed.|Bayesian modeling||Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.|Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.||1.85||0.9996
91650719|NCT01772368|183194255|OTHER|linearity statistical test|||||<|0.0001||||||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.||A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.||||<0.0001
91650720|NCT01772368|183194255|SUPERIORITY||LSM difference|251.3|||<|0.0001|TWO_SIDED|95.0|215.6|287.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||287.1|215.6|<0.0001
91650721|NCT01772368|183194255|SUPERIORITY||LSM difference|227.56|||<|0.0001|TWO_SIDED|95.0|191.6|263.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||263.5|191.6|<0.0001
91650722|NCT01772368|183194255|SUPERIORITY||LSM difference|196.85|||<|0.0001|TWO_SIDED|95.0|161.2|232.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||232.5|161.2|<0.0001
91790625|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.702|TWO_SIDED|95.0|-0.254|0.171||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.171|-0.254|0.702
91790626|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790627|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.111||0.566|TWO_SIDED|95.0|-0.155|0.283||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.283|-0.155|0.566
91790628|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790629|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.141|TWO_SIDED|95.0|-0.458|0.065||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.065|-0.458|0.141
91790630|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790631|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.131||0.834|TWO_SIDED|95.0|-0.285|0.23||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.230|-0.285|0.834
91790632|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790633|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.133||0.724|TWO_SIDED|95.0|-0.309|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.215|-0.309|0.724
91790634|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91603698|NCT00484315|183100124|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.|Mean Difference (Final Values)|-0.0294|STANDARD_DEVIATION|0.08253||0.997|ONE_SIDED|95.0||0.1078||P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.|Bayesian modeling||Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.|Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.||0.1078||0.9970
91603699|NCT04533711|183100136|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.3086|TWO_SIDED|95.0|-7.68|24.38|||Mixed Models Analysis|||||24.38|-7.68|0.3086
91603700|NCT04533711|183100137|SUPERIORITY||Mean Difference (Final Values)|10.93||||0.182|TWO_SIDED|95.0|-5.06|26.92|||Mixed Models Analysis|||||26.92|-5.06|0.1820
91603701|NCT04533711|183100138|SUPERIORITY||Mean Difference (Final Values)|308.4||||0.094|TWO_SIDED|95.0|-50.2|667.1|||Mixed Models Analysis|||||667.1|-50.2|0.094
91603702|NCT04533711|183100139|SUPERIORITY||Mean Difference (Final Values)|352.0||||0.0691|TWO_SIDED|95.0|-25.2|729.2|||Mixed Models Analysis|||||729.2|-25.2|0.0691
91603703|NCT04533711|183100140|SUPERIORITY||Mean Difference (Final Values)|-5.85||||0.4953|TWO_SIDED|95.0|-22.6|10.94|||Mixed Models Analysis|||||10.94|-22.6|0.4953
91603704|NCT04533711|183100141|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.8041|TWO_SIDED|95.0|-20.0|15.49|||Mixed Models Analysis|||||15.49|-20.0|0.8041
91603705|NCT04533711|183100142|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.9645|TWO_SIDED|95.0|-2.86|2.99|||Mixed Models Analysis|||||2.99|-2.86|0.9645
91603706|NCT04533711|183100143|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0989|TWO_SIDED|95.0|-5.85|0.49|||Mixed Models Analysis|||||0.49|-5.85|0.0989
91603707|NCT04533711|183100144|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7667|TWO_SIDED|95.0|-0.77|1.05|||Mixed Models Analysis|||||1.05|-0.77|0.7667
91603708|NCT04533711|183100145|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0894|TWO_SIDED|95.0|-1.87|0.13|||Mixed Models Analysis|||||0.13|-1.87|0.0894
91603709|NCT02689492|183100151|OTHER||Intercept|68.5027|STANDARD_DEVIATION|8.0355|||||||||||Standard deviation is actually standard error.|||||
91603710|NCT02689492|183100152|OTHER||Intercept|95.4051|STANDARD_DEVIATION|6.9951|||||||||||Standard deviation is actually standard error.|||||
91603711|NCT02689492|183100153|OTHER||Intercept|74.8895|STANDARD_DEVIATION|8.0048|||||||||||Standard deviation is actually standard error.|||||
91603712|NCT02338843|183100198|SUPERIORITY||Odds Ratio (OR)|7.95|||<|0.001|TWO_SIDED|95.0|4.76|13.3|||Regression, Logistic|Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.||||13.3|4.76|<0.001
91603713|NCT00110305|183100199|SUPERIORITY_OR_OTHER||Differences in response rate|0.5||||0.92|TWO_SIDED|95.0|-10.4|11.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||11.3|-10.4|0.92
91603714|NCT00110305|183100199|SUPERIORITY_OR_OTHER||Difference in response rate|-2.3||||0.56|TWO_SIDED|95.0|-13.6|9.0||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||9.0|-13.6|0.56
91603715|NCT00110305|183100199|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||0.62|TWO_SIDED|95.0|-14.0|8.4||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||8.4|-14.0|0.62
91603716|NCT00110305|183100199|SUPERIORITY_OR_OTHER||Difference in response rate|-1.5||||0.8|TWO_SIDED|95.0|-10.5|7.5||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.5|-10.5|0.80
91603717|NCT00110305|183100200|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.1|7.6||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||7.6|-17.1|0.45
91603718|NCT00110305|183100200|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.3|7.7||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.7|-17.3|0.45
91603719|NCT00110305|183100200|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||0.99|TWO_SIDED|95.0|-12.9|12.8||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||12.8|-12.9|0.99
91603720|NCT00110305|183100200|SUPERIORITY_OR_OTHER||Differences in response|2.6||||0.63|TWO_SIDED|95.0|-8.1|13.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||13.3|-8.1|0.63
91603721|NCT00110305|183100202|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||||95.0|-14.7|9.1||||||||9.1|-14.7|
91603722|NCT01252966|183100225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.14|TWO_SIDED|95.0|0.42|1.13|||Regression, Logistic|||Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen's one-sample d=0.38).||1.13|0.42|0.14
91603723|NCT01252966|183100227|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
91790635|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.166||0.163|TWO_SIDED|95.0|-0.559|0.095||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.095|-0.559|0.163
91603724|NCT01252966|183100228|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
91603725|NCT01252966|183100229|SUPERIORITY_OR_OTHER|||||||0.033||||||Results would not survive correction for multiple hypothesis testing.|Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.033
91603726|NCT03275870|183100239|OTHER|||||||0.042||||||p value \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.042
91603727|NCT03275870|183100240|OTHER|||||||0.213||||||P value of \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.213
91790636|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790637|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.163||0.497|TWO_SIDED|95.0|-0.432|0.21||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.210|-0.432|0.497
91790638|NCT02880956|183460072|SUPERIORITY||effect size|0.1|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790639|NCT02880956|183460072|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.919|TWO_SIDED|95.0|-0.314|0.349||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.349|-0.314|0.919
91603728|NCT00522392|183100266|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Log Rank|||Stratified log rank test was used to compare progression-free survival between the two arms.||||0.092
91790640|NCT02880956|183460072|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790641|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.352||0.423|TWO_SIDED|95.0|-0.974|0.409||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.974|0.423
91790642|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790643|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED|95.0|-1.408|-0.047||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.047|-1.408|0.036
91790644|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|2.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790645|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.355||0.121|TWO_SIDED|95.0|-1.25|0.147||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.147|-1.250|0.121
91790646|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790647|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.371||0.244|TWO_SIDED|95.0|-1.163|0.296||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.296|-1.163|0.244
91790648|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790649|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.36||0.085|TWO_SIDED|95.0|-1.33|0.086||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.086|-1.330|0.085
91790650|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|3.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790651|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.371||0.137|TWO_SIDED|95.0|-1.28|0.177||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.177|-1.280|0.137
91790652|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.19|STANDARD_DEVIATION|2.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790653|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.352||0.258|TWO_SIDED|95.0|-0.294|1.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.091|-0.294|0.258
91523098|NCT02313909|182921675|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.00451|TWO_SIDED|95.0|1.13|2.0|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.00|1.13|0.00451
91523099|NCT02313909|182921676|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.04409|TWO_SIDED|95.0|1.0|4.02|||Log Rank|||Statistical analysis 1: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.02|1.00|0.04409
91523100|NCT04026165|182921682|SUPERIORITY||Difference in Adjusted Mean|1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1439|TWO_SIDED|95.0|-0.41|2.81|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcr from treatment-specific Baselines at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for treatment-specific Baseline eGFRcr, pre-run-in urine albumin to creatinine ratio (UACR) category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||2.81|-0.41|0.1439
91523101|NCT04026165|182921683|SUPERIORITY||Difference in Percentage|0.1||||0.8353|TWO_SIDED|95.0|-10.9|11.4||p-value was based on Cochran-Mantel-Haenszel test stratified by Randomization stratification factors. Randomization stratification factors= pre-run-in eGFRcr stratum, pre-run-in UACR category and concomitant use of SGLT-2 inhibitors at Randomization.|Cochran-Mantel-Haenszel||95% exact CI based on the Santner-Snell method was presented for the difference in proportions between SEL and placebo arms.|||11.4|-10.9|0.8353
91523102|NCT04026165|182921684|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.201|TWO_SIDED|95.0|0.81|2.72|||Stratified Log-Rank|P-value was calculated using a stratified log-rank test, stratified by randomization stratification factors.|Hazard ratio and 95% CI were estimated using a stratified Cox proportional hazard model, stratified by randomization stratification factors and were reported only for outcomes with more than 10 events, and have at least 1 event in each treatment arm.|||2.72|0.81|0.2010
91523103|NCT04026165|182921686|SUPERIORITY||Difference in Adjusted Mean|0.44|STANDARD_ERROR_OF_MEAN|0.72||0.5399|TWO_SIDED|95.0|-0.97|1.86|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcys from pre-run-in Baseline at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for pre-run-in Baseline eGFRcys, pre-run-in UACR category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of SGLT-2 inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||1.86|-0.97|0.5399
91603729|NCT00522392|183100267|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used to compare the response rates between the two arms.||||0.029
91603730|NCT00522392|183100268|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Log Rank|||Stratified log-rank test was used to compare overall survival between the two arms.||||0.48
91613700|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.71||||0.009|TWO_SIDED|95.0|0.54|0.92||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.||0.92|0.54|0.009
91790654|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523104|NCT01257880|182921688|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.||||0.39
91523105|NCT01059630|182921695|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Log Rank|||||0.70|0.40|<0.0001
91523106|NCT01059630|182921697|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.45|0.73|||Log Rank|||||0.73|0.45|<0.0001
91523107|NCT01059630|182921698|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|0.98||||0.9298|TWO_SIDED|95.0|0.58|1.65|||Cochran-Mantel-Haenszel|||||1.65|0.58|0.9298
91523108|NCT01059630|182921699|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|-0.9||||0.7857|TWO_SIDED|95.0|-8.44|6.64|||Cochran-Mantel-Haenszel|||||6.64|-8.44|0.7857
91790655|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.348||0.711|TWO_SIDED|95.0|-0.555|0.814||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.814|-0.555|0.711
91790656|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|3.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790657|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.503|TWO_SIDED|95.0|-0.454|0.924||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.924|-0.454|0.503
91523109|NCT01059630|182921704|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|2.24||||0.8347|TWO_SIDED|95.0|-7.2|11.69|||Cochran-Mantel-Haenszel|||||11.69|-7.20|0.8347
91523110|NCT01059630|182921705|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|8.55||||0.0466|TWO_SIDED|95.0|-0.22|17.32|||Cochran-Mantel-Haenszel|||||17.32|-0.22|0.0466
91523111|NCT01059630|182921706|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.31|0.61||||||||0.61|0.31|
91603731|NCT03575104|183100298|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-11.62||||0.0001|TWO_SIDED|95.0|-17.604|-5.633||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-5.633|-17.604|0.0001
91603732|NCT03575104|183100298|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.74||||0.3669|TWO_SIDED|95.0|-8.693|3.215||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00977; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.215|-8.693|0.3669
91603733|NCT03575104|183100299|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-10.25||||0.0028|TWO_SIDED|95.0|-16.95|-3.548||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.01563; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-3.548|-16.95|0.0028
91603734|NCT03575104|183100299|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-1.95||||0.5686|TWO_SIDED|95.0|-8.666|4.764||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 10 mg vs placebo).||4.764|-8.666|0.5686
91603735|NCT03575104|183100300|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-6.45||||0.0303|TWO_SIDED|95.0|-12.282|-0.614||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-0.614|-12.282|0.0303
91650723|NCT01772368|183194255|SUPERIORITY||LSM difference|151.71|||<|0.0001|TWO_SIDED|95.0|115.9|187.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||187.5|115.9|<0.0001
91650724|NCT01772368|183194255|SUPERIORITY||LSM difference|193.42|||<|0.0001|TWO_SIDED|95.0|157.4|229.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100|The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||229.5|157.4|<0.0001
91650725|NCT01772368|183194255|SUPERIORITY||LSM difference|57.88||||0.0017|TWO_SIDED|95.0|22.0|93.7||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||93.7|22.0|0.0017
91709545|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.171||||0.0273|TWO_SIDED|95.0|-0.323|-0.019|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.019|-0.323|0.0273
91790658|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91603736|NCT03575104|183100300|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.61||||0.3782|TWO_SIDED|95.0|-8.41|3.197||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00195; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.197|-8.41|0.3782
91603737|NCT03575104|183100301|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-9.01||||0.0053|TWO_SIDED|95.0|-15.339|-2.684||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00313; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.684|-15.339|0.0053
91603738|NCT03575104|183100301|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-3.19||||0.3233|TWO_SIDED|95.0|-9.528|3.146||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||3.146|-9.528|0.3233
91603739|NCT03575104|183100302|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|16.13|||<|0.0001|TWO_SIDED|95.0|8.224|24.035||Hypothesis testing result: threshold for significance p = 0.0125; statistically significant = YES|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||24.035|8.224|<.0001
91613701|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.||1.12|0.65|0.26
91603740|NCT03575104|183100302|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.37|||=|0.0009|TWO_SIDED|95.0|5.507|21.226||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 10 mg vs placebo).||21.226|5.507|= 0.0009
91603741|NCT03575104|183100303|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|19.06|||<|0.0001|TWO_SIDED|95.0|10.125|27.994||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00781; statistically significant = YES||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||27.994|10.125|<.0001
91709546|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0266|TWO_SIDED|95.0|-0.339|-0.021|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.021|-0.339|0.0266
91790659|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.404||0.978|TWO_SIDED|95.0|-0.806|0.784||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.784|-0.806|0.978
91790660|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790661|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.402||0.265|TWO_SIDED|95.0|-1.239|0.342||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.342|-1.239|0.265
91790662|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790663|NCT02880956|183460073|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.414||0.789|TWO_SIDED|95.0|-0.704|0.925||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.704|0.789
91790664|NCT02880956|183460073|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|2.82|||TWO_SIDED|||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.||||
91790665|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.6||0.72|TWO_SIDED|95.0|-0.965|1.395||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.395|-0.965|0.720
91790666|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|4.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790667|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.592||0.455|TWO_SIDED|95.0|-1.607|0.722||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.722|-1.607|0.455
91790668|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790669|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|0.43|STANDARD_ERROR_OF_MEAN|0.605||0.473|TWO_SIDED|95.0|-0.755|1.625||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.625|-0.755|0.473
91790670|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790671|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.686||0.813|TWO_SIDED|95.0|-1.187|1.512||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.512|-1.187|0.813
91790672|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|5.3|||TWO_SIDED|||||||||Week 48||||
91790673|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.672||0.421|TWO_SIDED|95.0|-1.863|0.78||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.780|-1.863|0.421
91523112|NCT01059630|182921707|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.67||||||||0.67|0.39|
91603742|NCT03575104|183100303|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.58|||=|0.0028|TWO_SIDED|95.0|4.691|22.475||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 10 mg vs placebo).||22.475|4.691|= 0.0028
91603743|NCT03575104|183100304|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.75|||=|0.0733|TWO_SIDED|95.0|-1.581|0.071||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00625; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.071|-1.581|= 0.0733
91603744|NCT03575104|183100304|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.43|||=|0.3048|TWO_SIDED|95.0|-1.251|0.392||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 10 mg vs placebo).||0.392|-1.251|= 0.3048
91613702|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.85||||0.23|TWO_SIDED|95.0|0.64|1.11||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.||1.11|0.64|0.23
91650726|NCT01772368|183194255|SUPERIORITY||LSM difference|34.14||||0.0624|TWO_SIDED|95.0|-1.8|70.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||70.1|-1.8|0.0624
91650727|NCT01772368|183194255|SUPERIORITY||LSM difference|3.42||||0.8503|TWO_SIDED|95.0|-32.3|39.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||39.1|-32.3|0.8503
91650728|NCT01772368|183194255|SUPERIORITY||LSM difference|-41.72||||0.0229|TWO_SIDED|95.0|-77.6|-5.8||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-5.8|-77.6|0.0229
91523113|NCT01059630|182921708|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.04|0.45||||||||0.45|0.04|
91790674|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|5.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790675|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.687||0.758|TWO_SIDED|95.0|-1.139|1.564||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.564|-1.139|0.758
91790676|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|5.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790677|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.815||0.511|TWO_SIDED|95.0|-2.14|1.066||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-2.140|0.511
91523114|NCT01059630|182921709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.29|0.81||||||||0.81|0.29|
91523115|NCT01059630|182921710|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.44|0.74|||Log Rank|||||0.74|0.44|0.0001
91603745|NCT03575104|183100305|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-1.25|||=|0.012|TWO_SIDED|95.0|-2.23|-0.276||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00391; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||-0.276|-2.230|= 0.0120
91603746|NCT03575104|183100305|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.73|||=|0.1393|TWO_SIDED|95.0|-1.706|0.239||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 10 mg vs placebo).||0.239|-1.706|= 0.1393
91603747|NCT03575104|183100306|OTHER||LS mean difference to placebo|0.93||||0.2506|TWO_SIDED|95.0|0.82|1.05||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||1.05|0.82|0.2506
91603748|NCT03575104|183100306|OTHER||LS mean difference to placebo|0.8||||0.0004|TWO_SIDED|95.0|0.71|0.91||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.91|0.71|0.0004
91603749|NCT03575104|183100307|OTHER||LS mean difference to placebo|0.96||||0.5037|TWO_SIDED|95.0|0.84|1.09||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||1.09|0.84|0.5037
91603750|NCT03575104|183100307|OTHER||LS mean difference to placebo|0.81||||0.0021|TWO_SIDED|95.0|0.71|0.93||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.93|0.71|0.0021
91603751|NCT01111305|183100339|EQUIVALENCE|Equivalence is defined as p≥0.05||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91603752|NCT00891995|183100348|SUPERIORITY_OR_OTHER|||||||0.49||||||One-sided p-value.|ANCOVA|Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.||||||0.49
91603753|NCT00891995|183100351|SUPERIORITY_OR_OTHER|||||||0.4||||||One-sided p-value|ANCOVA|Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis||||||0.40
91603754|NCT02054702|183100358|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.||||<0.0001
91603755|NCT02054702|183100358|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.||||<0.0001
91603756|NCT02054702|183100359|SUPERIORITY_OR_OTHER|||||||0.4244|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.||||0.4244
91603757|NCT02054702|183100359|SUPERIORITY_OR_OTHER|||||||0.7623|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.||||0.7623
91603758|NCT02054702|183100360|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.8759
91709547|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.9023|TWO_SIDED|95.0|-0.196|0.173|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||0.173|-0.196|0.9023
91603759|NCT02054702|183100360|SUPERIORITY_OR_OTHER|||||||0.2176|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.2176
91603760|NCT02054702|183100361|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.||||0.8420
91603761|NCT02054702|183100361|SUPERIORITY_OR_OTHER|||||||0.3781|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.||||0.3781
91603762|NCT02054702|183100362|SUPERIORITY_OR_OTHER|||||||0.1807|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.||||0.1807
91603763|NCT02054702|183100362|SUPERIORITY_OR_OTHER|||||||0.2802|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.||||0.2802
91603764|NCT02054702|183100363|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.||||0.8622
91603765|NCT02054702|183100363|SUPERIORITY_OR_OTHER|||||||0.4848|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.||||0.4848
91603766|NCT02054702|183100364|SUPERIORITY_OR_OTHER|||||||0.8588|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.||||0.8588
91603767|NCT02054702|183100364|SUPERIORITY_OR_OTHER|||||||0.9928|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.||||0.9928
91709548|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.096||||0.3298|TWO_SIDED|95.0|-0.291|0.098|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.098|-0.291|0.3298
91603768|NCT02054702|183100365|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.||||<0.0001
91603769|NCT02054702|183100365|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.||||<0.0001
91603770|NCT02054702|183100368|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.||||<0.0001
91603771|NCT02054702|183100368|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.||||<0.0001
91603772|NCT02054702|183100369|SUPERIORITY_OR_OTHER|||||||0.0392|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.||||0.0392
91603773|NCT02054702|183100369|SUPERIORITY_OR_OTHER|||||||0.9716|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.||||0.9716
91523116|NCT01059630|182921712|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.081|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0810
91603774|NCT02388295|183100390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.24||0.13|ONE_SIDED|||||Not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline within treatment arm||||0.13
91603775|NCT02388295|183100390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.25||0.91|ONE_SIDED|||||not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline||||0.91
91603776|NCT02388295|183100390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.68|ONE_SIDED||||||ANOVA|no adjustments|larger negagtive values (powereed to detect -0.50)|Change from baseline||||0.68
91603777|NCT02388295|183100390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.34||0.32|TWO_SIDED|||||no adjustment|ANOVA||Looking for negative direction to indicate treatment better than placebo|Secondary objective - comparison to placebo||||0.32
91603778|NCT02388295|183100390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.36||0.45|TWO_SIDED|||||no adjustment|ANOVA||lookin for negative difference compared to placebo|Secondary objective||||0.45
91603779|NCT00516919|183100421|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.45|||=|0.51||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at post-treatment, controlling for baseline BMI.||||=0.51
91603780|NCT00516919|183100421|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.69|||=|0.41||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.||||=0.41
91603781|NCT03371355|183100422|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0343|TWO_SIDED|95.0|-41.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-41|0.0343
91603782|NCT03371355|183100422|SUPERIORITY||Mean Difference in % CFB|-44.0|||<|0.0001|TWO_SIDED|95.0|-56.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-28|-56|<0.0001
91603783|NCT03371355|183100422|SUPERIORITY||Mean Difference in % CFB|-37.0||||0.0009|TWO_SIDED|95.0|-52.0|-17.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-17|-52|0.0009
91603784|NCT03371355|183100423|SUPERIORITY||Least Squares Mean Difference|-49.87|||<|0.0001|TWO_SIDED|95.0|-62.68|-37.06|||ANCOVA|||||-37.06|-62.68|<0.0001
91603785|NCT03371355|183100423|SUPERIORITY||Least Squares Mean Difference|-71.66|||<|0.0001|TWO_SIDED|95.0|-84.47|-58.85|||ANCOVA|||||-58.85|-84.47|<0.0001
91603786|NCT03371355|183100423|SUPERIORITY||Least Squares Mean Difference|-59.74|||<|0.0001|TWO_SIDED|95.0|-74.04|-45.44|||ANCOVA|||||-45.44|-74.04|<0.0001
91603787|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-16.5||||0.0327|TWO_SIDED|95.0|-31.59|-1.39|||ANCOVA|||TC||-1.39|-31.59|0.0327
91603788|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-52.15|-21.94|||ANCOVA|||TC||-21.94|-52.15|<0.0001
91603789|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-31.6||||0.0003|TWO_SIDED|95.0|-48.23|-15.05|||ANCOVA|||TC||-15.05|-48.23|0.0003
91603790|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|7.5||||0.256|TWO_SIDED|95.0|-5.55|20.54|||ANCOVA|||LDL-C||20.54|-5.55|0.2560
91603791|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-8.6||||0.1795|TWO_SIDED|95.0|-21.26|4.05|||ANCOVA|||LDL-C||4.05|-21.26|0.1795
91790678|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|6.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790679|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.801||0.192|TWO_SIDED|95.0|-2.623|0.527||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.527|-2.623|0.192
91790680|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523117|NCT00985985|182921757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.3851|TWO_SIDED|95.0|0.78|1.92|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center)|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||1.92|0.78|0.3851
91603792|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-8.8||||0.2065|TWO_SIDED|95.0|-22.48|4.95|||ANCOVA|||LDL-C||4.95|-22.48|0.2065
91603793|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-2.7||||0.1515|TWO_SIDED|95.0|-6.43|1.01|||ANCOVA|||HDL-C||1.01|-6.43|0.1515
91603794|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.29|-4.91|||ANCOVA|||HDL-C||-4.91|-12.29|<0.0001
91603795|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-4.1||||0.0436|TWO_SIDED|95.0|-8.18|-0.12|||ANCOVA|||HDL-C||-0.12|-8.18|0.0436
91603796|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-9.1||||0.0224|TWO_SIDED|95.0|-16.94|-1.33|||ANCOVA|||VLDL-C||-1.33|-16.94|0.0224
91603797|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-15.4||||0.0001|TWO_SIDED|95.0|-22.94|-7.84|||ANCOVA|||VLDL-C||-7.84|-22.94|0.0001
91603798|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-10.8||||0.0091|TWO_SIDED|95.0|-18.86|-2.78|||ANCOVA|||VLDL-C||-2.78|-18.86|0.0091
91603799|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0748|TWO_SIDED|95.0|-29.12|1.42|||ANCOVA|||Non-HDL-C||1.42|-29.12|0.0748
91603800|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-28.4||||0.0004|TWO_SIDED|95.0|-43.68|-13.18|||ANCOVA|||Non-HDL-C||-13.18|-43.68|0.0004
91603801|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-27.4||||0.0016|TWO_SIDED|95.0|-44.08|-10.64|||ANCOVA|||Non-HDL-C||-10.64|-44.08|0.0016
91790681|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|0.69|STANDARD_ERROR_OF_MEAN|0.816||0.398|TWO_SIDED|95.0|-0.914|2.294||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.294|-0.914|0.398
91603802|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-2.44||||0.6005|TWO_SIDED|95.0|-11.68|6.8|||ANCOVA|||ApoB||6.80|-11.68|0.6005
91603803|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-9.83||||0.0374|TWO_SIDED|95.0|-19.07|-0.59|||ANCOVA|||ApoB||-0.59|-19.07|0.0374
91603804|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-5.28||||0.31|TWO_SIDED|95.0|-15.55|5.0|||ANCOVA|||ApoB||5.00|-15.55|0.3100
91603805|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-1.002||||0.0728|TWO_SIDED|95.0|-2.1|0.09|||ANCOVA|||ApoB-48||0.09|-2.10|0.0728
91603806|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-1.803||||0.0018|TWO_SIDED|95.0|-2.91|-0.69|||ANCOVA|||ApoB-48||-0.69|-2.91|0.0018
91603807|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-1.091||||0.0759|TWO_SIDED|95.0|-2.3|0.12|||ANCOVA|||ApoB-48||0.12|-2.30|0.0759
91790682|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|5.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790683|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|0.97|STANDARD_ERROR_OF_MEAN|0.924||0.296|TWO_SIDED|95.0|-0.851|2.784||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.784|-0.851|0.296
91790684|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|6.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790685|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.907||0.706|TWO_SIDED|95.0|-2.126|1.442||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.442|-2.126|0.706
91603808|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-0.887||||0.8451|TWO_SIDED|95.0|-9.89|8.11|||ANCOVA|||ApoB-100||8.11|-9.89|0.8451
91603809|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-7.59||||0.0973|TWO_SIDED|95.0|-16.59|1.41|||ANCOVA|||ApoB-100||1.41|-16.59|0.0973
91603810|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-3.418||||0.5|TWO_SIDED|95.0|-13.45|6.61|||ANCOVA|||ApoB-100||6.61|-13.45|0.5000
91603811|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-4.753||||0.0008|TWO_SIDED|95.0|-7.47|-2.03|||ANCOVA|||ApoCIII||-2.03|-7.47|0.0008
91603812|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-8.499|||<|0.0001|TWO_SIDED|95.0|-11.18|-5.82|||ANCOVA|||ApoCIII||-5.82|-11.18|<0.0001
91603813|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-6.86|||<|0.0001|TWO_SIDED|95.0|-9.78|-3.93|||ANCOVA|||ApoCIII||-3.93|-9.78|<0.0001
91603814|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-16.8||||0.0003|TWO_SIDED|95.0|-25.8|-7.85|||ANCOVA|||ApoA1||-7.85|-25.80|0.0003
91603815|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-44.07|-26.24|||ANCOVA|||ApoA1||-26.24|-44.07|<0.0001
91603816|NCT03371355|183100424|SUPERIORITY||Least Squares Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-30.89|-11.39|||ANCOVA|||ApoA1||-11.39|-30.89|<0.0001
91603817|NCT03371355|183100425|SUPERIORITY||Least Squares Mean Difference|0.0128||||0.8299|TWO_SIDED|95.0|-0.1|0.13|||ANCOVA|||||0.13|-0.10|0.8299
91603818|NCT03371355|183100425|SUPERIORITY||Least Squares Mean Difference|-0.0144||||0.8102|TWO_SIDED|95.0|-0.13|0.1|||ANCOVA|||||0.10|-0.13|0.8102
91603819|NCT03371355|183100425|SUPERIORITY||Least Squares Mean Difference|-0.0146||||0.8223|TWO_SIDED|95.0|-0.14|0.11|||ANCOVA|||||0.11|-0.14|0.8223
91603820|NCT03371355|183100426|SUPERIORITY||Least Squares Mean Difference|7.8||||0.0604|TWO_SIDED|95.0|-0.35|16.02|||ANCOVA|||Lp(a)||16.02|-0.35|0.0604
91603821|NCT03371355|183100426|SUPERIORITY||Least Squares Mean Difference|1.6||||0.7048|TWO_SIDED|95.0|-6.61|9.74|||ANCOVA|||Lp(a)||9.74|-6.61|0.7048
91603822|NCT03371355|183100426|SUPERIORITY||Least Squares Mean Difference|-1.7||||0.7024|TWO_SIDED|95.0|-10.65|7.2|||ANCOVA|||Lp(a)||7.20|-10.65|0.7024
91603823|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-45.0|||<|0.0001|TWO_SIDED|95.0|-54.0|-33.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-33|-54|<0.0001
91603824|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-54|-69|<0.0001
91603825|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-47.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-47|-66|<0.0001
91790686|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|6.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790687|NCT02880956|183460074|SUPERIORITY||LS Mean of Difference|1.79|STANDARD_ERROR_OF_MEAN|0.929||0.055|TWO_SIDED|95.0|-0.036|3.617||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.617|-0.036|0.055
91790688|NCT02880956|183460074|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|6.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790689|NCT02880956|183460075|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.651|TWO_SIDED|95.0|-0.266|0.166||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.166|-0.266|0.651
91603826|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0309|TWO_SIDED|95.0|-16.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-1|-16|0.0309
91603827|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-19.0|||<|0.0001|TWO_SIDED|95.0|-26.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-12|-26|<0.0001
91603828|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-25.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-9|-25|<0.0001
91603829|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|6.0||||0.4016|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||21|-7|0.4016
91603830|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2589|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||6|-18|0.2589
91603831|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.0616|TWO_SIDED|95.0|-24.0|1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||1|-24|0.0616
91603832|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.1918|TWO_SIDED|95.0|-18.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||4|-18|0.1918
91603833|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-32.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||-14|-32|<0.0001
91650729|NCT01772368|183194255|SUPERIORITY||LSM difference|-193.42|||<|0.0001|TWO_SIDED|95.0|-229.5|-157.4||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-157.4|-229.5|<0.0001
91603834|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.1132|TWO_SIDED|95.0|-21.0|3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||3|-21|0.1132
91603835|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0177|TWO_SIDED|95.0|-40.0|-5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-5|-40|0.0177
91790690|NCT02880956|183460075|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790691|NCT02880956|183460075|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.107||0.32|TWO_SIDED|95.0|-0.318|0.104||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.104|-0.318|0.320
91790692|NCT02880956|183460075|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91603836|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-38.0|||<|0.0001|TWO_SIDED|95.0|-51.0|-23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-23|-51|<0.0001
91603837|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0033|TWO_SIDED|95.0|-45.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-12|-45|0.0033
91603838|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0523|TWO_SIDED|95.0|-18.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||0|-18|0.0523
91603839|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-18.0||||0.0002|TWO_SIDED|95.0|-26.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-26|0.0002
91790693|NCT02880956|183460075|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.757|TWO_SIDED|95.0|-0.25|0.182||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.182|-0.250|0.757
91790694|NCT02880956|183460075|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790695|NCT02880956|183460075|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.121||0.984|TWO_SIDED|95.0|-0.241|0.236||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.236|-0.241|0.984
91790696|NCT02880956|183460075|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91603840|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-19.0||||0.0004|TWO_SIDED|95.0|-28.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-28|0.0004
91603841|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4204|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-12|0.4204
91603842|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0441|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||0|-16|0.0441
91603843|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1324|TWO_SIDED|95.0|-16.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||2|-16|0.1324
91603844|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-29.0||||0.1009|TWO_SIDED|95.0|-53.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||7|-53|0.1009
91603845|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-52.0||||0.0005|TWO_SIDED|95.0|-68.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||-28|-68|0.0005
91603846|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.3004|TWO_SIDED|95.0|-50.0|24.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||24|-50|0.3004
91603847|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.6135|TWO_SIDED|95.0|-10.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||7|-10|0.6135
91603848|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1127|TWO_SIDED|95.0|-15.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||2|-15|0.1127
91650730|NCT01772368|183194256|SUPERIORITY||LSM difference|226.77|||<|0.0001|TWO_SIDED|95.0|172.4|281.1||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||281.1|172.4|<0.0001
91650731|NCT01772368|183194256|SUPERIORITY||LSM difference|198.32|||<|0.0001|TWO_SIDED|95.0|143.7|252.9||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||252.9|143.7|<0.0001
91790697|NCT02880956|183460075|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.595|TWO_SIDED|95.0|-0.296|0.17||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.170|-0.296|0.595
91603849|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.2576|TWO_SIDED|95.0|-14.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||4|-14|0.2576
91790698|NCT02880956|183460075|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91603850|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0017|TWO_SIDED|95.0|-52.0|-16.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-16|-52|0.0017
91603851|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-68.0|-45.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-45|-68|<0.0001
91603852|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-47.0|||<|0.0001|TWO_SIDED|95.0|-61.0|-29.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-29|-61|<0.0001
91790699|NCT02880956|183460075|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.122||0.67|TWO_SIDED|95.0|-0.187|0.291||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.291|-0.187|0.670
91790700|NCT02880956|183460075|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790701|NCT02880956|183460076|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.112||0.722|TWO_SIDED|95.0|-0.26|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.260|0.722
91790702|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790703|NCT02880956|183460076|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.878|TWO_SIDED|95.0|-0.232|0.198||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.198|-0.232|0.878
91650732|NCT01772368|183194256|SUPERIORITY||LSM difference|158.99|||<|0.0001|TWO_SIDED|95.0|104.7|213.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.3|104.7|<0.0001
91790704|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91523118|NCT00985985|182921757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0565|TWO_SIDED|95.0|0.99|3.32|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center).|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||3.32|0.99|0.0565
91523119|NCT03532308|182921785|SUPERIORITY|||||||0.76||||||This is for the effect of treatment with time, risk stratification and treatment\*time interaction in the model.|Mixed Models Analysis|||||||0.76
91790705|NCT02880956|183460076|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.112||0.535|TWO_SIDED|95.0|-0.151|0.29||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.290|-0.151|0.535
91523120|NCT03720938|182921791|SUPERIORITY|A sample size of 26 children per group was needed with the assumption of Cohen's d = 0.8, the alpha error of 0.05 and a power of 80%.||||||0.001||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.001
91523121|NCT03720938|182921791|OTHER|||||||0.0002535||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.0002535
91523122|NCT03720938|182921791|SUPERIORITY|||||||0.000397||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.000397
91523123|NCT03720938|182921792|SUPERIORITY|||||||0.005||||||The outcome of weight z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z scores.||||0.005
91790706|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91523124|NCT03720938|182921792|SUPERIORITY|||||||0.002||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z score.||||0.002
91523125|NCT03720938|182921792|SUPERIORITY|||||||0.00386||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality. Adjusted by Satterthwaite's degrees of freedom correction method for cluster effect, and small sample sizes in addition to baseline value and age.||||0.00386
91523126|NCT03720938|182921793|SUPERIORITY|||||||0||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.000
91790707|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.916|TWO_SIDED|95.0|-0.266|0.239||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.239|-0.266|0.916
91603853|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-11.0||||0.0193|TWO_SIDED|95.0|-20.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-2|-20|0.0193
91603854|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-26.0|||<|0.0001|TWO_SIDED|95.0|-33.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-19|-33|<0.0001
91603855|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0063|TWO_SIDED|95.0|-23.0|-4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-4|-23|0.0063
91603856|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.8873|TWO_SIDED|95.0|-21.0|23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||23|-21|0.8873
91790708|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790709|NCT02880956|183460076|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.126||0.511|TWO_SIDED|95.0|-0.33|0.165||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.165|-0.330|0.511
91790710|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790711|NCT02880956|183460076|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.129||0.771|TWO_SIDED|95.0|-0.217|0.292||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.292|-0.217|0.771
91650733|NCT01772368|183194256|SUPERIORITY||LSM difference|116.96|||<|0.0001|TWO_SIDED|95.0|62.4|171.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||171.6|62.4|<0.0001
91790712|NCT02880956|183460076|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||Week 96||||
91790713|NCT02880956|183460077|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.086||0.903|TWO_SIDED|95.0|-0.159|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.159|0.903
91790714|NCT02880956|183460077|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790715|NCT02880956|183460077|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.084||0.811|TWO_SIDED|95.0|-0.185|0.145||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.145|-0.185|0.811
91790716|NCT02880956|183460077|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790717|NCT02880956|183460077|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.086||0.775|TWO_SIDED|95.0|-0.145|0.194||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.194|-0.145|0.775
91790718|NCT02880956|183460077|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790719|NCT02880956|183460077|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.273|TWO_SIDED|95.0|-0.337|0.096||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.096|-0.337|0.273
91790720|NCT02880956|183460077|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790721|NCT02880956|183460077|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.74|TWO_SIDED|95.0|-0.248|0.176||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.176|-0.248|0.740
91790722|NCT02880956|183460077|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790723|NCT02880956|183460077|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.567|TWO_SIDED|95.0|-0.282|0.155||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.155|-0.282|0.567
91790724|NCT02880956|183460077|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790725|NCT02880956|183460078|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.099||0.931|TWO_SIDED|95.0|-0.204|0.187||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.187|-0.204|0.931
91790726|NCT02880956|183460078|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790727|NCT02880956|183460078|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.097||0.187|TWO_SIDED|95.0|-0.32|0.063||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.063|-0.320|0.187
91790728|NCT02880956|183460078|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790729|NCT02880956|183460078|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.961|TWO_SIDED|95.0|-0.191|0.201||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.201|-0.191|0.961
91790730|NCT02880956|183460078|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790731|NCT02880956|183460078|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.124||0.894|TWO_SIDED|95.0|-0.26|0.227||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.227|-0.260|0.894
91790732|NCT02880956|183460078|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523127|NCT03720938|182921793|SUPERIORITY|||||||3.06e-06||||||"Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.~Adjusted for cluster effect, and small sample sizes, baseline value and age."|Linear mixed effects model|Satterthwaite's correction method for denominator degrees of freedom.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000306
91523128|NCT03720938|182921793|SUPERIORITY|||||||3.67e-06||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000367
91523129|NCT03720938|182921794|SUPERIORITY|||||||0||||||The outcome of body mass index z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index z score at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.000
91603857|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.4404|TWO_SIDED|95.0|-27.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||15|-27|0.4404
91523130|NCT03720938|182921794|SUPERIORITY|||||||0.0001402||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.0001402
91523131|NCT03720938|182921794|SUPERIORITY|||||||0.000235||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body index z score.||||0.000235
91523132|NCT03720938|182921795|SUPERIORITY|||||||0.259||||||The outcomes of fat ratio was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the fat ratio at baseline and confounding variable age.|ANCOVA|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.259
91523133|NCT03720938|182921795|SUPERIORITY|||||||0.22||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.220
91523134|NCT03720938|182921795|SUPERIORITY|||||||0.250006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.250006
91603858|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB]|-1.0||||0.9665|TWO_SIDED|95.0|-22.0|27.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||27|-22|0.9665
91603859|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB]|-7.0||||0.4133|TWO_SIDED|95.0|-21.0|10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||10|-21|0.4133
91523135|NCT03720938|182921796|SUPERIORITY|||||||0||||||The outcome of visual reaction time was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the weight at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.000
91523136|NCT03720938|182921796|SUPERIORITY|Adjusted for the weight at baseline and confounding variable age.||||||1.196e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of visual reaction time was tested for any difference between groups by linear mixed-effects model analysis.||||0.00001196
91523137|NCT03720938|182921796|SUPERIORITY||||||‬|2.82e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.0000282‬
91523138|NCT03720938|182921797|SUPERIORITY|||||||0||||||The outcome of visual reaction time of non-dominant hand was tested for any difference between groups.|ANCOVA|Adjusted for the visual reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.000
91709549|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6205|TWO_SIDED|95.0|-0.251|0.15|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.150|-0.251|0.6205
91790733|NCT02880956|183460078|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.121||0.917|TWO_SIDED|95.0|-0.226|0.251||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.251|-0.226|0.917
91523139|NCT03720938|182921797|SUPERIORITY|||||||9e-08||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.00000009
91603860|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB]|-6.0||||0.475|TWO_SIDED|95.0|-20.0|11.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||11|-20|0.4750
91603861|NCT03371355|183100427|SUPERIORITY||Mean Difference in % CFB]|-4.0||||0.6354|TWO_SIDED|95.0|-20.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||15|-20|0.6354
91603862|NCT03371355|183100428|SUPERIORITY||Least Squares Mean Difference|-17.2||||0.1799|TWO_SIDED|95.0|-42.53|8.1|||ANCOVA|||||8.10|-42.53|0.1799
91603863|NCT03371355|183100428|SUPERIORITY||Least Squares Mean Difference|13.8||||0.2867|TWO_SIDED|95.0|-11.83|39.49|||ANCOVA|||||39.49|-11.83|0.2867
91603864|NCT03371355|183100428|SUPERIORITY||Least Squares Mean Difference|2.2||||0.8812|TWO_SIDED|95.0|-26.78|31.14|||ANCOVA|||||31.14|-26.78|0.8812
91603865|NCT03371355|183100429|SUPERIORITY||Least Squares Mean Difference|-0.28||||0.3995|TWO_SIDED|95.0|-0.94|0.38|||ANCOVA|||||0.38|-0.94|0.3995
91603866|NCT03371355|183100429|SUPERIORITY||Least Squares Mean Difference|0.08||||0.8155|TWO_SIDED|95.0|-0.59|0.75|||ANCOVA|||||0.75|-0.59|0.8155
91603867|NCT03371355|183100429|SUPERIORITY||Least Squares Mean Difference|0.16||||0.6466|TWO_SIDED|95.0|-0.54|0.86|||ANCOVA|||||0.86|-0.54|0.6466
91603868|NCT03371355|183100430|SUPERIORITY||Least Squares Mean Difference|1.39||||0.7393|TWO_SIDED|95.0|-9.66|6.89|||ANCOVA|||||6.89|-9.66|0.7393
91603869|NCT03371355|183100430|SUPERIORITY||Least Squares Mean Difference|-0.13||||0.9744|TWO_SIDED|95.0|-8.45|8.18|||ANCOVA|||||8.18|-8.45|0.9744
91603870|NCT03371355|183100430|SUPERIORITY||Least Squares Mean Difference|3.58||||0.4477|TWO_SIDED|95.0|-5.75|12.91|||ANCOVA|||||12.91|-5.75|0.4477
91603871|NCT03371355|183100431|SUPERIORITY||Least Squares Mean Difference|-1.794||||0.471|TWO_SIDED|95.0|-6.72|3.14|||ANCOVA|||||3.14|-6.72|0.4710
91603872|NCT03371355|183100431|SUPERIORITY||Least Squares Mean Difference|0.26||||0.9169|TWO_SIDED|95.0|-4.68|5.2|||ANCOVA|||||5.20|-4.68|0.9169
91603873|NCT03371355|183100431|SUPERIORITY||Least Squares Mean Difference|2.133||||0.4484|TWO_SIDED|95.0|-3.44|7.7|||ANCOVA|||||7.70|-3.44|0.4484
91603874|NCT03371355|183100432|SUPERIORITY||Least Squares Mean Difference|-23.2||||0.0916|TWO_SIDED|95.0|-50.17|3.83|||ANCOVA|||||3.83|-50.17|0.0916
91603875|NCT03371355|183100432|SUPERIORITY||Least Squares Mean Difference|-11.4||||0.4032|TWO_SIDED|95.0|-38.51|15.63|||ANCOVA|||||15.63|-38.51|0.4032
91603876|NCT03371355|183100432|SUPERIORITY||Least Squares Mean Difference|1.9||||0.8959|TWO_SIDED|95.0|-27.56|31.45|||ANCOVA|||||31.45|-27.56|0.8959
91603877|NCT03371355|183100433|SUPERIORITY||Least Squares Mean Difference|-0.052||||0.3202|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.3202
91603878|NCT03371355|183100433|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.8485|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||||0.09|-0.11|0.8485
91603879|NCT03371355|183100433|SUPERIORITY||Least Squares Mean Difference|0.0314||||0.5812|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|||||0.14|-0.08|0.5812
91603880|NCT03371355|183100434|SUPERIORITY||Least Squares Mean Difference|0.43||||0.6157|TWO_SIDED|95.0|-1.28|2.15|||ANCOVA|||||2.15|-1.28|0.6157
91603881|NCT03371355|183100434|SUPERIORITY||Least Squares Mean Difference|0.01||||0.9869|TWO_SIDED|95.0|-1.66|1.69|||ANCOVA|||||1.69|-1.66|0.9869
91603882|NCT03371355|183100434|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.7084|TWO_SIDED|95.0|-2.07|1.42|||ANCOVA|||||1.42|-2.07|0.7084
91603883|NCT03371355|183100435|SUPERIORITY||Least Squares Mean Difference|2.79||||0.4431|TWO_SIDED|95.0|-4.41|10.0|||ANCOVA|||SBP||10.00|-4.41|0.4431
91603884|NCT03371355|183100435|SUPERIORITY||Least Squares Mean Difference|2.08||||0.563|TWO_SIDED|95.0|-5.05|9.22|||ANCOVA|||SBP||9.22|-5.05|0.5630
91790734|NCT02880956|183460078|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790735|NCT02880956|183460078|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.124||0.639|TWO_SIDED|95.0|-0.186|0.303||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.303|-0.186|0.639
91790736|NCT02880956|183460078|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91603885|NCT03371355|183100435|SUPERIORITY||Least Squares Mean Difference|-1.63||||0.6634|TWO_SIDED|95.0|-9.06|5.79|||ANCOVA|||SBP||5.79|-9.06|0.6634
91603886|NCT03371355|183100435|SUPERIORITY||Least Squares Mean Difference|4.11||||0.0937|TWO_SIDED|95.0|-0.71|8.92|||ANCOVA|||DBP||8.92|-0.71|0.0937
91790737|NCT02880956|183460079|SUPERIORITY||LS Mean of Difference|-1.57|STANDARD_ERROR_OF_MEAN|2.175||0.47|TWO_SIDED|95.0|-5.851|2.703||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.703|-5.851|0.470
91790738|NCT02880956|183460079|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|15.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790739|NCT02880956|183460079|SUPERIORITY||LS Mean of Difference|0.36|STANDARD_ERROR_OF_MEAN|2.127||0.864|TWO_SIDED|95.0|-3.819|4.548||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||4.548|-3.819|0.864
91603887|NCT03371355|183100435|SUPERIORITY||Least Squares Mean Difference|3.49||||0.1522|TWO_SIDED|95.0|-1.31|8.28|||ANCOVA|||DBP||8.28|-1.31|0.1522
91603888|NCT03371355|183100435|SUPERIORITY||Least Squares Mean Difference|1.62||||0.5188|TWO_SIDED|95.0|-3.35|6.59|||ANCOVA|||DBP||6.59|-3.35|0.5188
91603889|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|0.57||||0.5299|TWO_SIDED|95.0|-1.24|2.39|||ANCOVA|||Weight||2.39|-1.24|0.5299
91603890|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|-0.12||||0.8919|TWO_SIDED|95.0|-1.89|1.65|||ANCOVA|||Weight||1.65|-1.89|0.8919
91603891|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6653|TWO_SIDED|95.0|-2.25|1.44|||ANCOVA|||Weight||1.44|-2.25|0.6653
91603892|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|2.35||||0.4213|TWO_SIDED|95.0|-3.43|8.14|||ANCOVA|||SBP||8.14|-3.43|0.4213
91603893|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|1.23||||0.6696|TWO_SIDED|95.0|-4.49|6.96|||ANCOVA|||SBP||6.96|-4.49|0.6696
91603894|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|-1.23||||0.6819|TWO_SIDED|95.0|-7.2|4.73|||ANCOVA|||SBP||4.73|-7.20|0.6819
91603895|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|5.01||||0.1171|TWO_SIDED|95.0|-1.28|11.31|||ANCOVA|||DBP||11.31|-1.28|0.1171
91603896|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|3.94||||0.2155|TWO_SIDED|95.0|-2.33|10.21|||ANCOVA|||DBP||10.21|-2.33|0.2155
91603897|NCT03371355|183100436|SUPERIORITY||Least Squares Mean Difference|1.7||||0.6034|TWO_SIDED|95.0|-4.79|8.2|||ANCOVA|||DBP||8.20|-4.79|0.6034
91603898|NCT03371355|183100437|SUPERIORITY||Least Squares Mean Difference|0.98||||0.5752|TWO_SIDED|95.0|-2.48|4.44|||ANCOVA|||||4.44|-2.48|0.5752
91603899|NCT03371355|183100437|SUPERIORITY||Least Squares Mean Difference|4.09||||0.023|TWO_SIDED|95.0|0.58|7.59|||ANCOVA|||||7.59|0.58|0.0230
91603900|NCT03371355|183100437|SUPERIORITY||Least Squares Mean Difference|1.57||||0.3965|TWO_SIDED|95.0|-2.1|5.25|||ANCOVA|||||5.25|-2.10|0.3965
91603901|NCT03371355|183100438|SUPERIORITY||Least Squares Mean Difference|12.44||||0.3023|TWO_SIDED|95.0|-11.39|36.26|||ANCOVA|||||36.26|-11.39|0.3023
91603902|NCT03371355|183100438|SUPERIORITY||Least Squares Mean Difference|26.03||||0.035|TWO_SIDED|95.0|1.87|50.19|||ANCOVA|||||50.19|1.87|0.0350
91603903|NCT03371355|183100438|SUPERIORITY||Least Squares Mean Difference|12.27||||0.3374|TWO_SIDED|95.0|-13.02|37.55|||ANCOVA|||||37.55|-13.02|0.3374
91650734|NCT01772368|183194256|SUPERIORITY||LSM difference|159.01|||<|0.0001|TWO_SIDED|95.0|104.3|213.7||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.7|104.3|<0.0001
91790740|NCT02880956|183460079|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|15.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91603904|NCT03371355|183100440|SUPERIORITY||Least Squares Mean Difference|-2.59||||0.4583|TWO_SIDED|95.0|-9.49|4.31|||ANCOVA|||||4.31|-9.49|0.4583
91603905|NCT03371355|183100440|SUPERIORITY||Least Squares Mean Difference|-5.71||||0.0943|TWO_SIDED|95.0|-12.43|1.0|||ANCOVA|||||1.00|-12.43|0.0943
91603906|NCT03371355|183100440|SUPERIORITY||Least Squares Mean Difference|-4.57||||0.1909|TWO_SIDED|95.0|-11.45|2.32|||ANCOVA|||||2.32|-11.45|0.1909
91603907|NCT03371355|183100441|SUPERIORITY||Least Squares Mean Difference|7.1||||0.1294|TWO_SIDED|95.0|-2.1|16.22|||ANCOVA|||ALT||16.22|-2.10|0.1294
91603908|NCT03371355|183100441|SUPERIORITY||Least Squares Mean Difference|14.8||||0.0012|TWO_SIDED|95.0|5.98|23.59|||ANCOVA|||ALT||23.59|5.98|0.0012
91603909|NCT03371355|183100441|SUPERIORITY||Least Squares Mean Difference|8.9||||0.0594|TWO_SIDED|95.0|-0.36|18.11|||ANCOVA|||ALT||18.11|-0.36|0.0594
91603910|NCT03371355|183100441|SUPERIORITY||[Least Squares Mean Difference|5.0||||0.073|TWO_SIDED|95.0|-0.47|10.45|||ANCOVA|||AST||10.45|-0.47|0.0730
91603911|NCT03371355|183100441|SUPERIORITY||Least Squares Mean Difference|8.4||||0.002|TWO_SIDED|95.0|3.17|13.7|||ANCOVA|||AST||13.70|3.17|0.0020
91603912|NCT03371355|183100441|SUPERIORITY||Least Squares Mean Difference|6.5||||0.02|TWO_SIDED|95.0|1.05|12.0|||ANCOVA|||AST||12.00|1.05|0.0200
91603913|NCT03371355|183100442|SUPERIORITY||Least Squares Mean Difference|-1.19||||0.4812|TWO_SIDED|95.0|-4.55|2.16|||ANCOVA|||||2.16|-4.55|0.4812
91603914|NCT03371355|183100442|SUPERIORITY||Least Squares Mean Difference|-1.53||||0.3679|TWO_SIDED|95.0|-4.88|1.83|||ANCOVA|||||1.83|-4.88|0.3679
91603915|NCT03371355|183100442|SUPERIORITY||Least Squares Mean Difference|-4.18||||0.021|TWO_SIDED|95.0|-7.72|-0.65|||ANCOVA|||||-0.65|-7.72|0.0210
91603916|NCT03371355|183100443|SUPERIORITY||Least Squares Mean Difference|-0.15||||0.6227|TWO_SIDED|95.0|-0.73|0.44|||ANCOVA|||||0.44|-0.73|0.6227
91603917|NCT03371355|183100443|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.195|TWO_SIDED|95.0|-0.97|0.2|||ANCOVA|||||0.20|-0.97|0.1950
91603918|NCT03371355|183100443|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.2271|TWO_SIDED|95.0|-1.0|0.24|||ANCOVA|||||0.24|-1.00|0.2271
91603919|NCT03371355|183100444|SUPERIORITY||Least Squares Mean Difference|17.06||||0.8591|TWO_SIDED|95.0|-173.57|207.69|||ANCOVA|||SAT||207.69|-173.57|0.8591
91603920|NCT03371355|183100444|SUPERIORITY||Least Squares Mean Difference|32.92||||0.7404|TWO_SIDED|95.0|-164.11|229.95|||ANCOVA|||SAT||229.95|-164.11|0.7404
91603921|NCT03371355|183100444|SUPERIORITY||Least Squares Mean Difference|-16.3||||0.8711|TWO_SIDED|95.0|-215.5|182.9|||ANCOVA|||SAT||182.90|-215.50|0.8711
91603922|NCT03371355|183100444|SUPERIORITY||Least Squares Mean Difference|4.95||||0.9569|TWO_SIDED|95.0|-176.64|186.53|||ANCOVA|||VAT||186.53|-176.64|0.9569
91603923|NCT03371355|183100444|SUPERIORITY||Least Squares Mean Difference|-24.26||||0.8025|TWO_SIDED|95.0|-216.53|168.02|||ANCOVA|||VAT||168.02|-216.53|0.8025
91603924|NCT03371355|183100444|SUPERIORITY||Least Squares Mean Difference|22.02||||0.8202|TWO_SIDED|95.0|-170.09|214.12|||ANCOVA|||VAT||214.12|-170.09|0.8202
91603925|NCT03371355|183100445|SUPERIORITY||Least Squares Mean Difference|0.11||||0.9734|TWO_SIDED|95.0|-6.47|6.69|||ANCOVA|||||6.69|-6.47|0.9734
91603926|NCT03371355|183100445|SUPERIORITY||Least Squares Mean Difference|-0.7||||0.8333|TWO_SIDED|95.0|-7.25|5.86|||ANCOVA|||||5.86|-7.25|0.8333
91603927|NCT03371355|183100445|SUPERIORITY||Least Squares Mean Difference|1.66||||0.6207|TWO_SIDED|95.0|-4.99|8.31|||ANCOVA|||||8.31|-4.99|0.6207
91787540|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
91603928|NCT03371355|183100446|SUPERIORITY||Least Squares Mean Difference|0.01||||0.8026|TWO_SIDED|95.0|-0.04|0.06|||ANCOVA|||||0.06|-0.04|0.8026
91603929|NCT03371355|183100446|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.4917|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA|||||0.03|-0.07|0.4917
91603930|NCT03371355|183100446|SUPERIORITY||Least Squares Mean Difference|0.0||||0.8916|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||||0.05|-0.05|0.8916
91603931|NCT03371355|183100447|SUPERIORITY||Least Squares Mean Difference|0.11||||0.728|TWO_SIDED|95.0|-0.5|0.71|||ANCOVA|||||0.71|-0.50|0.7280
91603932|NCT03371355|183100447|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.7354|TWO_SIDED|95.0|-0.69|0.49|||ANCOVA|||||0.49|-0.69|0.7354
91603933|NCT03371355|183100447|SUPERIORITY||Least Squares Mean Difference|-0.23||||0.4682|TWO_SIDED|95.0|-0.84|0.39|||ANCOVA|||||0.39|-0.84|0.4682
91603934|NCT03400800|183100468|SUPERIORITY||Mean Difference (Final Values)|-53.5|||<|0.0001|TWO_SIDED|95.0|-56.66|-50.35||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-50.35|-56.66|<0.0001
91603935|NCT03400800|183100469|SUPERIORITY||Mean Difference (Final Values)|-49.17|||<|0.0001|TWO_SIDED|95.0|-51.57|-46.77||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.77|-51.57|<0.0001
91603936|NCT03400800|183100470|SUPERIORITY||Median Difference (Final Values)|-51.87|||<|0.0001|TWO_SIDED|95.0|-55.01|-48.72||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-48.72|-55.01|<.0001
91603937|NCT03400800|183100471|SUPERIORITY||Mean Difference (Final Values)|-48.94|||<|0.0001|TWO_SIDED|95.0|-51.39|-46.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.48|-51.39|<0.0001
91603938|NCT03400800|183100472|SUPERIORITY||Mean Difference (Final Values)|-79.27|||<|0.0001|TWO_SIDED|95.0|-81.97|-76.57||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-76.57|-81.97|<0.0001
91603939|NCT03400800|183100473|SUPERIORITY||Mean Difference (Final Values)|-29.79|||<|0.0001|TWO_SIDED|95.0|-31.78|-27.81||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-27.81|-31.78|<0.0001
91603940|NCT03400800|183100474|SUPERIORITY||Mean Difference (Final Values)|-38.94|||<|0.0001|TWO_SIDED|95.0|-41.21|-36.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-36.67|-41.21|<0.0001
91603941|NCT03400800|183100475|SUPERIORITY||Mean Difference (Final Values)|-43.32|||<|0.0001|TWO_SIDED|95.0|-46.04|-40.6||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-40.60|-46.04|<0.0001
91603942|NCT01512264|183100477|OTHER|||||||0.006|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.||||0.006
91603943|NCT01512264|183100477|OTHER|||||||0.015|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.||||0.015
91603944|NCT01512264|183100477|OTHER|||||||0.203|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.203
91603945|NCT01512264|183100477|OTHER|||||||0.01|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.||||0.010
91603946|NCT01512264|183100478|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
91603947|NCT01512264|183100478|OTHER|||||||0.618|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.||||0.618
91603948|NCT01512264|183100478|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.||||1.000
91603949|NCT01512264|183100478|OTHER|||||||0.019|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.||||0.019
91603950|NCT01512264|183100480|OTHER|||||||0.118|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.||||0.118
91603951|NCT01512264|183100480|OTHER|||||||0.482|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.482
91650735|NCT01772368|183194256|SUPERIORITY||LSM difference|67.76||||0.015|TWO_SIDED|95.0|13.3|122.2||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||122.2|13.3|0.0150
91650736|NCT01772368|183194256|SUPERIORITY||LSM difference|39.31||||0.1578|TWO_SIDED|95.0|-15.3|94.0||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||94.0|-15.3|0.1578
91603952|NCT01512264|183100480|OTHER|||||||0.368|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.||||0.368
91603953|NCT01512264|183100480|OTHER|||||||0.147|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.||||0.147
91603954|NCT01512264|183100481|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
91603955|NCT01512264|183100481|OTHER|||||||0.695|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.||||0.695
91603956|NCT01512264|183100481|OTHER|||||||0.175|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.||||0.175
91603957|NCT01512264|183100481|OTHER|||||||0.518|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.||||0.518
91650737|NCT01772368|183194256|SUPERIORITY||LSM difference|-0.02||||0.9993|TWO_SIDED|95.0|-54.4|54.4||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||54.4|-54.4|0.9993
91650738|NCT01772368|183194256|SUPERIORITY||LSM difference|-42.05||||0.1311|TWO_SIDED|95.0|-96.7|12.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||12.6|-96.7|0.1311
91603958|NCT01512264|183100483|OTHER|||||||0.109|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.||||0.109
91603959|NCT01512264|183100483|OTHER|||||||0.485|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.485
91603960|NCT01512264|183100483|OTHER|||||||0.864|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.||||0.864
91603961|NCT01512264|183100483|OTHER|||||||0.341|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.||||0.341
91523140|NCT03720938|182921797|SUPERIORITY|||||||55||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||000000055
91603962|NCT01512264|183100484|OTHER|||||||0.899|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.||||0.899
91603963|NCT01512264|183100484|OTHER|||||||0.519|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.||||0.519
91523141|NCT03720938|182921798|SUPERIORITY|||||||0||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.000
91523142|NCT03720938|182921798|SUPERIORITY|||||||1.633e-05||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by linear mixed-effects analysis.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.00001633
91523143|NCT03720938|182921798|SUPERIORITY|||||||3.67e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.0000367
91603964|NCT01512264|183100484|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.||||1.000
91603965|NCT01512264|183100484|OTHER|||||||0.14|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.||||0.140
91650739|NCT01772368|183194256|SUPERIORITY||LSM difference|-159.01|||<|0.0001|TWO_SIDED|95.0|-213.7|-104.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-104.3|-213.7|<0.0001
91603966|NCT01512264|183100486|OTHER|||||||0.52|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.||||0.520
91603967|NCT01512264|183100486|OTHER|||||||0.8|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.||||0.800
91603968|NCT01512264|183100486|OTHER|||||||0.148|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.||||0.148
91603969|NCT01512264|183100486|OTHER|||||||0.787|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.||||0.787
91603970|NCT01512264|183100487|OTHER|||||||0.239|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.||||0.239
91603971|NCT01512264|183100487|OTHER|||||||0.212|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.||||0.212
91603972|NCT01512264|183100487|OTHER|||||||0.12|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.||||0.120
91603973|NCT01512264|183100487|OTHER|||||||0.263|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.||||0.263
91603974|NCT00854828|183100497|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91603975|NCT00996203|183100521|SUPERIORITY_OR_OTHER||||||<|0.001||||||EQ-5D scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
91603976|NCT00996203|183100524|SUPERIORITY_OR_OTHER||||||<|0.001||||||General health at baseline Versus Week 24|t-test, 2 sided|||||||<0.001
91603977|NCT00996203|183100526|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline Versus Week 24 DAS28 scores|t-test, 2 sided|||||||<0.001
91603978|NCT00996203|183100528|SUPERIORITY_OR_OTHER||||||<|0.001||||||Mean HAQ scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
91603979|NCT00848120|183100615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
91603980|NCT00848120|183100616|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
91603981|NCT00848120|183100617|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||Week 24 versus baseline||||0.001
91603982|NCT01988090|183100624|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
91603983|NCT01988090|183100626|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91603984|NCT02440581|183100697|OTHER|T-tests||||||0.443|||||||t-test, 2 sided|||||||.443
91603985|NCT02440581|183100698|OTHER|T-tests||||||0.49|||||||t-test, 2 sided|||||||.490
91603986|NCT02440581|183100699|OTHER|T-tests|||||<|0.001|||||||t-test, 2 sided|||||||<.001
91603987|NCT02440581|183100700|OTHER|T-Tests||||||0.083|||||||t-test, 2 sided|||||||.083
91603988|NCT02440581|183100701|OTHER|T-tests||||||0.283|||||||t-test, 2 sided|||||||.283
91603989|NCT01445678|183100733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-8.91|0.54||||||||0.54|-8.91|
91603990|NCT01445678|183100734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.52|2.59||||||||2.59|-4.52|
91603991|NCT01445678|183100735|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.23|0.89||||||||0.89|-7.23|
91603992|NCT01445678|183100736|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-3.4|2.33||||||||2.33|-3.4|
91603993|NCT01445678|183100737|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-9.09|0.94||||||||0.94|-9.09|
91603994|NCT01445678|183100738|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-0.88|2.37||||||||2.37|-0.88|
91603995|NCT01565980|183100750|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen's d: difference between LS means divided by the standard deviation.|Mixed Models Analysis|||The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.||||<.05
91603996|NCT01565980|183100751|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
91603997|NCT01565980|183100752|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<.05
91603998|NCT01565980|183100753|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
91603999|NCT01565980|183100754|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
91604000|NCT01565980|183100755|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
91604001|NCT01565980|183100756|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values above 0.05 are considered statistically insignificant in this study.|Descriptive statistics for outcomes|||||||<0.05
91604002|NCT02078219|183100764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.28|||<|0.0001|TWO_SIDED|95.0|-36.99|-21.57|||ANCOVA, LOCF|||||-21.57|-36.99|<0.0001
91604003|NCT02078219|183100764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.25|||<|0.0001|TWO_SIDED|95.0|-56.97|-41.52|||ANCOVA, LOCF|||||-41.52|-56.97|<0.0001
91604004|NCT02078219|183100764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.33|||<|0.0001|TWO_SIDED|95.0|-61.0|-45.67|||ANCOVA, LOCF|||||-45.67|-61.00|<0.0001
91604005|NCT00891202|183100775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-30.03|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|-36.82|-23.24|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model fitted with treatment and baseline spleen severity (low spleen severity: spleen volume less than or equal to \[\<=\] 20 multiples of normal spleen volume, high spleen severity: spleen volume greater than \[\>\] 20 multiples of normal spleen volume).||-23.24|-36.82|<0.0001
91604006|NCT01993888|183100798|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91604007|NCT03124459|183100805|SUPERIORITY||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|5.2||0.01|TWO_SIDED|90.0|4.9|22.1|||ANCOVA|||||22.1|4.9|0.01
91604008|NCT03124459|183100806|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.16|TWO_SIDED|90.0|-6.8|0.6|||ANCOVA|||||0.6|-6.8|0.16
91790741|NCT02880956|183460079|SUPERIORITY||LS Mean of Difference|-4.49|STANDARD_ERROR_OF_MEAN|2.206||0.043|TWO_SIDED|95.0|-8.826|-0.15||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||-0.150|-8.826|0.043
91604009|NCT03124459|183100807|SUPERIORITY||Mean Difference (Final Values)|35.4|STANDARD_ERROR_OF_MEAN|23.5||0.13|TWO_SIDED|90.0|-3.2|74.0|||ANCOVA|||||74|-3.2|0.13
91604010|NCT03124459|183100808|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.5||0.73|TWO_SIDED|90.0|-7.1|10.9|||ANCOVA|||||10.9|-7.1|0.73
91604011|NCT03124459|183100809|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.7||0.51|TWO_SIDED|90.0|-4.6|10.9|||ANCOVA|||||10.9|-4.6|0.51
91604012|NCT03124459|183100814|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|3.9||0.63|TWO_SIDED|90.0|-8.4|4.6|||ANCOVA|||||4.6|-8.4|0.63
91604013|NCT03932812|183100815|SUPERIORITY||Mean Difference (Net)|1.128|STANDARD_ERROR_OF_MEAN|1.622||0.206|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.206
91604014|NCT03932812|183100816|SUPERIORITY||Mean Difference (Final Values)|2.376|STANDARD_ERROR_OF_MEAN|1.793||0.101|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.101
91604015|NCT03932812|183100817|SUPERIORITY||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|1.174||0.836|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.836
91604016|NCT03932812|183100818|SUPERIORITY||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.414||0.567|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|The outcome for this analyses is use of emergency care.||||0.567
91604017|NCT03932812|183100819|SUPERIORITY||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.165||0.014|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.014
91604018|NCT03932812|183100820|SUPERIORITY||Mean Difference (Final Values)|0.467|STANDARD_ERROR_OF_MEAN|0.301||0.01|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.010
91604019|NCT03932812|183100821|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|2.682||0.188|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.188
91604020|NCT03293654|183100822|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.28|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.18|1.39|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.39|1.18|
91604021|NCT03293654|183100822|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.03|1.22|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.22|1.03|
91604022|NCT03293654|183100822|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.14|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.05|1.24|||||Ratio of GLSM, EU is the numerator and US Avastin acts as the denominator|||1.24|1.05|
91790742|NCT02880956|183460079|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|16.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790743|NCT02880956|183460079|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|2.874||0.831|TWO_SIDED|95.0|-5.041|6.27||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||6.270|-5.041|0.831
91790744|NCT02880956|183460079|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|18.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790745|NCT02880956|183460079|SUPERIORITY||LS Mean of Difference|1.81|STANDARD_ERROR_OF_MEAN|2.843||0.525|TWO_SIDED|95.0|-3.784|7.404||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||7.404|-3.784|0.525
91604023|NCT03293654|183100823|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator|1.22|1.09|
91604024|NCT03293654|183100823|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||MB02 represents the numerator and EU Avastin represents the denominator|||1.22|1.09|
91604025|NCT03293654|183100823|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.07|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.0|1.13|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||1.13|1|
91604026|NCT03293654|183100830|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.962|1.07|||||MB02 in numerator and EU Avastin in denominator|||1.07|0.962|
91604027|NCT03293654|183100830|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.996|1.13|||||MB02 is numerator and US Avastin is denominator|||1.13|0.996|
91604028|NCT03293654|183100830|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.983|1.11|||||EU Avastin in the numerator and US Avastin in the denominator|||1.11|0.983|
91604029|NCT03293654|183100831|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.969|1.07|||||MB02: EU Avastin|||1.07|0.969|
91650740|NCT01772368|183194257|SUPERIORITY||geometric mean ratio|1.929|||||TWO_SIDED|90.0|1.69|2.202||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||2.202|1.690|
91523144|NCT03720938|182921799|SUPERIORITY|||||||0.008||||||The outcomes of auditory reaction time of non-dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.008
91604030|NCT03293654|183100831|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.998|1.12|||||MB02: US Avastin|||1.12|0.998|
91604031|NCT03293654|183100831|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.981|1.1|||||EU Avastin: US Avastin|||1.1|0.981|
91604032|NCT03293654|183100832|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|0.986|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.903|1.08|||||MB02: EU Avastin|||1.08|0.903|
91604033|NCT03293654|183100832|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.1|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.01|1.19|||||MB02: US Avastin|||1.19|1.01|
91604034|NCT03293654|183100832|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.02|1.22|||||EU Avastin: US Avastin|||1.22|1.02|
91604035|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.36|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-21.96|15.24|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 1||15.24|-21.96|
91604036|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-30.01|6.4|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg versus Placebo Day 1||6.40|-30.01|
91604037|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-42.99|-8.32|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 1||-8.32|-42.99|
91604038|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-5.06|34.53|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 28||34.53|-5.06|
91604039|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.22|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-14.64|23.08|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg vs Placebo Day 28||23.08|-14.64|
91604040|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.18|24.47|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 28||24.47|-11.18|
91650741|NCT01772368|183194257|SUPERIORITY||geometric mean ratio|0.8|||||TWO_SIDED|90.0|0.702|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.911|0.702|
91650742|NCT01772368|183194257|SUPERIORITY||geometric mean ratio|0.427|||||TWO_SIDED|90.0|0.376|0.485||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.485|0.376|
91650743|NCT01772368|183194257|SUPERIORITY||LSM difference|0.172|||||TWO_SIDED|90.0|0.151|0.196||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.196|0.151|
91650744|NCT01772368|183194258|SUPERIORITY||geometric mean ratio|3.622|||||TWO_SIDED|90.0|3.149|4.168||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||4.168|3.149|
91523145|NCT03720938|182921799|SUPERIORITY|||||||0.006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006
91650745|NCT01772368|183194258|SUPERIORITY||geometric mean ratio|1.534|||||TWO_SIDED|90.0|1.335|1.763||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||1.763|1.335|
91650746|NCT01772368|183194258|SUPERIORITY||geometric mean ratio|0.795|||||TWO_SIDED|90.0|0.694|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.911|0.694|
91650747|NCT01772368|183194258|SUPERIORITY||geometric mean ratio|0.339|||||TWO_SIDED|90.0|0.295|0.39||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.390|0.295|
91709550|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.018||||0.8817|TWO_SIDED|95.0|-0.253|0.217|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.217|-0.253|0.8817
91650748|NCT02449291|183194261|SUPERIORITY|||||||0.016|ONE_SIDED|95.0||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.016) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
91650749|NCT02449291|183194261|SUPERIORITY|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.015) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
91650750|NCT02449291|183194262|SUPERIORITY|||||||0.009||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.009
91650751|NCT02449291|183194262|SUPERIORITY|||||||0.002||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.002
91650752|NCT02449291|183194263|SUPERIORITY|||||||0.17||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.170
91650753|NCT02449291|183194263|SUPERIORITY|||||||0.552||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.552
91650754|NCT02449291|183194264|SUPERIORITY|||||||0.003|||||||Regression, Cox|||||||0.003
91650755|NCT02449291|183194264|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
91650756|NCT02449291|183194265|SUPERIORITY|||||||0.209|||||||Chi-squared|||||||0.209
91650757|NCT02449291|183194265|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.440
91650758|NCT02449291|183194266|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
91650759|NCT02449291|183194266|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
91790746|NCT02880956|183460079|OTHER||Effect size/pooled SD|0.1|STANDARD_ERROR_OF_MEAN|18.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91650760|NCT02449291|183194267|SUPERIORITY|||||||0.115|||||||Chi-squared|||||||0.115
91650761|NCT02449291|183194267|SUPERIORITY|||||||0.222|||||||Chi-squared|||||||0.222
91650762|NCT02449291|183194268|SUPERIORITY|||||||0.474|||||||Chi-squared|||||||0.474
91650763|NCT02449291|183194268|SUPERIORITY|||||||0.505|||||||Chi-squared|||||||0.505
91650764|NCT02449291|183194269|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
91650765|NCT02449291|183194269|SUPERIORITY|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
91650766|NCT02449291|183194270|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91650767|NCT02449291|183194270|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
91650768|NCT02462421|183194273|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||No adjustment for multiple comparisons. Viewed as unnecessary inasmuch as none of the comparisons achieved p\<0.05.|t-test, 2 sided|||"Each of the variant genotypes was compared to the control group (homozygous for major alleles at all three genetic loci) in an unpaired t-test. The study was terminated early because it was clear that we would not meet our recruitment targets and that the study was likely underpowered.~Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant."||||0.92
91650769|NCT02462421|183194273|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.63||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.63
91790747|NCT02880956|183460079|SUPERIORITY||LS Mean of Difference|-1.49|STANDARD_ERROR_OF_MEAN|2.921||0.61|TWO_SIDED|95.0|-7.239|4.255||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||4.255|-7.239|0.610
91790748|NCT02880956|183460079|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|19.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790749|NCT02880956|183460080|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.02||0.438|TWO_SIDED|95.0|-2.798|1.214||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||1.214|-2.798|0.438
91790750|NCT02880956|183460080|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|7.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790751|NCT02880956|183460080|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|1.005||0.419|TWO_SIDED|95.0|-1.164|2.788||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.788|-1.164|0.419
91790752|NCT02880956|183460080|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|7.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790753|NCT02880956|183460080|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|1.03||0.948|TWO_SIDED|95.0|-1.959|2.092||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.092|-1.959|0.948
91604041|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.92|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-28.73|2.9|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of the Placebo arm||2.90|-28.73|
91604042|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.18|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.69|22.05|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 10 mg arm||22.05|-11.69|
91604043|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.11|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-13.13|19.36|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 50 mg arm||19.36|-13.13|
91604044|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.39|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|4.47|34.3|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 125 mg arm||34.30|4.47|
91604045|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 1 Diabetes, Day 1|Intercept estimate was 125.45 and between participant standard deviation was 21.63|-0.129|-0.320|
91604046|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078|||||TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|||Type 1 Diabetes, Day 28|Intercept estimate was 125.45 and between participant standard deviation was 21.63|0.016|-0.171|
91604047|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 2 Diabetes, Day 1|Intercept estimate was 113.23 and between participant standard deviation was 21.63|-0.129|-0.320|
91604048|NCT01262898|183100848|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078||||||95.0|-0.171|0.016|||Mixed Models Analysis|||Type 2 Diabetes, Day 28|Intercept estimate was 113.23 and between participant standard deviation was 21.63|0.016|-0.171|
91604049|NCT01355289|183100904|SUPERIORITY_OR_OTHER||Difference in % of Responders|31.62||||0.0236|TWO_SIDED|95.0|5.39|57.84|||Cochran-Mantel-Haenszel|||||57.84|5.39|0.0236
91604050|NCT01355289|183100904|SUPERIORITY_OR_OTHER||Difference in % of Responders|60.78||||0.0003|TWO_SIDED|95.0|36.3|85.27|||Cochran-Mantel-Haenszel|||||85.27|36.30|0.0003
91604051|NCT01355289|183100904|SUPERIORITY_OR_OTHER||Difference in % of Responders|58.4||||0.0003|TWO_SIDED|95.0|30.92|85.88|||Cochran-Mantel-Haenszel|||||85.88|30.92|0.0003
91604052|NCT03618030|183100959|OTHER|||||||0.0003|||||||ANOVA|||The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.||||.0003
91604053|NCT00860470|183100960|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95||||0.36|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.06|0.86|0.36
91604054|NCT00860470|183100961|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.78|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.20|0.88|0.78
91604055|NCT00860470|183100962|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.04|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.04|0.63|0.11
91604056|NCT00860470|183100963|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.02|TWO_SIDED|95.0|0.81|0.99|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.99|0.81|0.02
91604057|NCT00860470|183100964|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.80|<0.001
91604058|NCT00860470|183100965|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.75||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.97|0.57|0.03
91604059|NCT00860470|183100966|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||<|0.001|TWO_SIDED|95.0|0.62|0.86|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.86|0.62|<0.001
91604060|NCT00860470|183100967|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.87|TWO_SIDED|95.0|0.81|0.93|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.93|0.81|0.87
91604061|NCT00860470|183100968|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||<|0.001|TWO_SIDED|95.0|0.85|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.85|<0.001
91604062|NCT00860470|183100969|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.13|TWO_SIDED|95.0|0.96|1.01|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.01|0.96|0.13
91604063|NCT00888238|183100974|SUPERIORITY_OR_OTHER||Least Squares Mean|1.7|||<|0.001||90.0|1.47|1.93|||ANOVA|||||1.93|1.47|<0.001
91604064|NCT00888238|183100975|SUPERIORITY_OR_OTHER||Least Squares Mean|1.3|||<|0.001||90.0|1.08|1.52|||ANOVA|||||1.52|1.08|<0.001
91604065|NCT01032629|183100976|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.4576|TWO_SIDED|95.0|0.78|1.12|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.12|0.78|=0.4576
91604066|NCT01032629|183100976|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0467|TWO_SIDED|95.0|0.68|1.0|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.68|=0.0467
91604067|NCT01032629|183100976|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.112|TWO_SIDED|95.0|0.75|1.03|||Cox proportional hazard method|||Comparison for canagliflozin versus placebo is reported here.||1.03|0.75|0.1120
91604068|NCT01032629|183100977|SUPERIORITY||Difference of Least Square Mean|2.79|STANDARD_ERROR_OF_MEAN|2.224|=|0.21|TWO_SIDED|95.0|-1.571|7.154|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||7.154|-1.571|=0.210
91604069|NCT01032629|183100977|SUPERIORITY||Difference of Least Square Mean|4.07|STANDARD_ERROR_OF_MEAN|2.261|=|0.072|TWO_SIDED|95.0|-0.368|8.504|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||8.504|-0.368|=0.072
91604070|NCT01032629|183100978|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.67|0.97|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.97|0.67|
91650770|NCT02462421|183194273|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.86||||||Not adjusted for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.86
91604071|NCT01032629|183100978|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.58|0.85|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.85|0.58|
91604072|NCT01032629|183100979|OTHER||Difference of Least Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|95.0|-0.429|0.374||||||Comparison for canagliflozin versus placebo is reported here.||0.374|-0.429|
91604073|NCT01032629|183100979|OTHER||Difference of Least Square Mean|0.33|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|95.0|-0.079|0.731||||||Comparison for canagliflozin versus placebo is reported here.||0.731|-0.079|
91604074|NCT01032629|183100980|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.8|0.94||||||Comparison for canagliflozin versus placebo is reported here.||0.940|0.800|
91604075|NCT01032629|183100980|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.77|0.91||||||Comparison for canagliflozin versus placebo is reported here.||0.910|0.770|
91604076|NCT01032629|183100981|OTHER||Difference of Least Square Mean|1.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|0.599|2.755||||||Comparison for canagliflozin versus placebo is reported here.||2.755|0.599|
91604077|NCT01032629|183100981|OTHER||Difference of Least Square Mean|1.24|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|95.0|0.16|2.328||||||Comparison for canagliflozin versus placebo is reported here.||2.328|0.160|
91650771|NCT02462421|183194274|OTHER|"We compared the two groups (wild type versus SLC2A9 variant homozygotes. Null hypothesis: there are no differences between the two groups with respect to the pharmacodynamic effect of canagliflozin on fractional excretion of uric acid in the urine."||||||0.04||||||Because the study was terminated early, we did not have sufficient statistical power to adjust for multiple comparisons. We are reporting a nominal p-value without adjusting for multiple comparisons|t-test, 2 sided|||The study was terminated early because of slow recruitment. As a result the study did not achieve the statistical power that had been planned.||||0.04
91650772|NCT02462421|183194275|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.07||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.07
91604078|NCT01032629|183100982|OTHER||Difference of Least Square Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.045|||TWO_SIDED|95.0|-0.355|-0.177||||||Comparison for canagliflozin versus placebo is reported here.||-0.177|-0.355|
91604079|NCT01032629|183100982|OTHER||Difference of Least Square Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.405|-0.227||||||Comparison for canagliflozin versus placebo is reported here.||-0.227|-0.405|
91604080|NCT01032629|183100983|OTHER||Difference of Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|-0.794|-0.374||||||Comparison for canagliflozin versus placebo is reported here.||-0.374|-0.794|
91604081|NCT01032629|183100983|OTHER||Difference of Least Square Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.945|-0.523||||||Comparison for canagliflozin versus placebo is reported here.||-0.523|-0.945|
91604082|NCT01032629|183100984|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.26||||95.0|-3.472|-2.454||||||Comparison for canagliflozin versus placebo is reported here.||-2.454|-3.472|
91604083|NCT01032629|183100984|OTHER||Difference of Least Square Mean|-3.61|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|-4.125|-3.103||||||Comparison for canagliflozin versus placebo is reported here.||-3.103|-4.125|
91604084|NCT01032629|183100985|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|95.0|-3.998|-1.914||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.914|-3.998|
91604085|NCT01032629|183100985|OTHER||Difference of Least Square Mean|-4.53|STANDARD_ERROR_OF_MEAN|0.534|||TWO_SIDED|95.0|-5.579|-3.484||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-3.484|-5.579|
91604086|NCT01032629|183100985|OTHER||Difference of Least Square Mean|-0.82|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-1.437|-0.205||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-0.205|-1.437|
91650773|NCT02462421|183194275|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.53||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.53
91790754|NCT02880956|183460080|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|8.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790755|NCT02880956|183460080|SUPERIORITY||LS Mean of Difference|-1.04|STANDARD_ERROR_OF_MEAN|1.597||0.516|TWO_SIDED|95.0|-4.18|2.101||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||2.101|-4.180|0.516
91790756|NCT02880956|183460080|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790757|NCT02880956|183460080|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|1.582||0.971|TWO_SIDED|95.0|-3.055|3.168||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||3.168|-3.055|0.971
91523146|NCT03720938|182921799|SUPERIORITY|||||||0.006602||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006602
91790758|NCT02880956|183460080|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|11.24|||TWO_SIDED|||||||||Week 96||||
91790759|NCT02880956|183460080|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.621||0.392|TWO_SIDED|95.0|-4.577|1.8||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||1.800|-4.577|0.392
91523147|NCT03720938|182921800|SUPERIORITY|||||||0.615648||||||The outcome of self-perception for sports competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for sports competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.615648
91604087|NCT01032629|183100985|OTHER||Difference of Least Square Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.316|||TWO_SIDED|95.0|-2.245|-1.007||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.007|-2.245|
91604088|NCT01032629|183100986|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.04|0.07||||||Comparison for canagliflozin versus placebo is reported here.||0.070|-0.040|
91604089|NCT01032629|183100986|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||Comparison for canagliflozin versus placebo is reported here.||0.080|-0.030|
91604090|NCT01032629|183100987|OTHER||Difference of Least Square Mean|0.18|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.105|0.259||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.259|0.105|
91604091|NCT01032629|183100987|OTHER||Difference of Least Square Mean|0.23|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.152|0.307||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.307|0.152|
91604092|NCT01032629|183100987|OTHER||Difference of Least Square Mean|0.05|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.031|0.065||||||Statistical analysis (HDL-C)||0.065|0.031|
91604093|NCT01032629|183100987|OTHER||Difference of Least Square Mean|0.06|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.04|0.075||||||Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here.||0.075|0.040|
91604094|NCT01032629|183100987|OTHER||Difference of Least Square Mean|0.11|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.046|0.17||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.170|0.046|
91604095|NCT01032629|183100987|OTHER||Difference of Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.102|0.226||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.226|0.102|
91604096|NCT01032629|183100988|OTHER||Difference of Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.04|0.076||||||||0.076|-0.040|
91604097|NCT01032629|183100988|OTHER||Difference of Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.023|0.094||||||||0.094|-0.023|
91604098|NCT00619957|183100992|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|4.53|||<|0.0001|TWO_SIDED|95.0|3.46|5.6|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.60|3.46|<0.0001
91604099|NCT00619957|183100993|SUPERIORITY_OR_OTHER||LS Mean Difference|2.56|||<|0.0001|TWO_SIDED|95.0|1.66|3.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.47|1.66|<0.0001
91604100|NCT00619957|183100994|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|||<|0.0001|TWO_SIDED|95.0|2.19|4.16|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||4.16|2.19|<0.0001
91787541|NCT01106092|183454573|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||4.72|-4.78|
91787542|NCT02434471|183454591|OTHER||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91787543|NCT02434471|183454592|OTHER||Mean Difference (Final Values)|0.1||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
91787544|NCT01473368|183454594|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
91787545|NCT01473368|183454598|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91787546|NCT04839562|183454602|SUPERIORITY||Mean Difference (Final Values)|-4.3|||=|0.0106|TWO_SIDED|95.0|-7.7|-1.0|||t-test, 2 sided|||||-1|-7.7|=.0106
91523148|NCT03720938|182921800|SUPERIORITY|||||||0.608||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.608
91523149|NCT03720938|182921800|SUPERIORITY|||||||0.60938||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.60938
91787547|NCT04839562|183454603|SUPERIORITY||||||=|0.002|||||||Fisher Exact|||||||=.002
91787548|NCT04839562|183454604|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
91787549|NCT04839562|183454605|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
91523150|NCT03720938|182921801|SUPERIORITY|||||||0.094||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for physical condition competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.094
91787550|NCT04839562|183454606|SUPERIORITY||||||=|0.0348|||||||Fisher Exact|||||||=.0348
91523151|NCT03720938|182921801|SUPERIORITY|||||||0.085||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.085
91523152|NCT03720938|182921801|SUPERIORITY|||||||0.08818||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.08818
91523153|NCT03720938|182921802|SUPERIORITY|||||||0.058102||||||The outcome of self-perception for strength competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for strength competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.058102
91787551|NCT04839562|183454607|SUPERIORITY||||||=|1|||||||Fisher Exact|||||||=1
91787552|NCT04839562|183454608|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
91787553|NCT04839562|183454609|SUPERIORITY||||||=|0.1864|||||||Fisher Exact|||||||=.1864
91787554|NCT04839562|183454610|SUPERIORITY||||||=|0.4173|||||||Fisher Exact|||||||=.4173
91787555|NCT04839562|183454611|SUPERIORITY||||||=|0.0343|||||||Fisher Exact|||||||=.0343
91787556|NCT04839562|183454612|SUPERIORITY||||||=|0.0636|||||||Fisher Exact|||||||=.0636
91787557|NCT04839562|183454613|SUPERIORITY||||||=|0.065|||||||Fisher Exact|||||||=.065
91787558|NCT04839562|183454614|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
91787559|NCT04839562|183454615|SUPERIORITY||||||=|0.2829|||||||Fisher Exact|||||||=.2829
91787560|NCT01347580|183454620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8214|TWO_SIDED|95.0|0.799|1.327||pvalue at 0.025 , adjusted for multiple comparisons|Regression, Logistic|||||1.327|0.799|0.8214
91787561|NCT01347580|183454621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.6322|TWO_SIDED|95.0|0.801|1.441||P value at 0.025 adjusted for multiple comparisons|Regression, Logistic|||||1.441|0.801|0.6322
91787562|NCT01347580|183454622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.027||||0.9056|TWO_SIDED|95.0|0.661|1.595|||Regression, Logistic|||||1.595|0.661|0.9056
91787563|NCT01347580|183454623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.4168|TWO_SIDED|95.0|0.76|1.942|||Regression, Logistic|||||1.942|0.760|0.4168
91787564|NCT01347580|183454624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.189||||0.0307|TWO_SIDED|95.0|0.042|0.856|||Regression, Logistic|||||0.856|0.042|0.0307
91787565|NCT01347580|183454625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.132||||0.344|TWO_SIDED|95.0|0.876|1.462|||Regression, Logistic|||||1.462|0.876|0.344
91787566|NCT01347580|183454626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.0547|TWO_SIDED|95.0|0.996|1.506|||Regression, Logistic|||||1.506|0.996|0.0547
91787567|NCT01347580|183454627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.803||||0.166|TWO_SIDED|95.0|0.588|1.096|||Regression, Logistic|||||1.096|0.588|0.1660
91787568|NCT00412373|183454642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.6||0.774||95.0|-2.7|3.7|||ANOVA|P-value based on the actual value and was from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|Paliperidone Extended Release (ER) - Placebo on the Actual Score.|||3.7|-2.7|0.774
91650774|NCT02462421|183194275|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
91650775|NCT02462421|183194276|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.|||||<|0.01||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||<0.01
91650776|NCT02462421|183194276|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.77||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.77
91650777|NCT02462421|183194276|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.65||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.65
91650778|NCT02462421|183194277|OTHER|Null hypothesis: None of the three genotypes is associated with an alteration in the pharmacodynamic effect of canagliflozin on urinary Na excretion||||||0.2||||||Because the study was terminated early, the study does not have sufficient statistical power to adjust for multiple comparisons. Accordingly, nominal p-values are reported.|t-test, 2 sided|||"The wild type genotype group was compared to homozygotes for each of the three other genotypes."||||0.20
91650779|NCT02462421|183194277|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.01
91523154|NCT03720938|182921802|SUPERIORITY|||||||0.051||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.051
91650780|NCT02462421|183194277|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.16||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.16
91787569|NCT00412373|183454643|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-13.8|-4.9|||ANCOVA|P-values are from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-4.9|-13.8|<0.001
91523155|NCT03720938|182921802|SUPERIORITY|||||||0.0534||||||The outcome of self-perception for strength competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.0534
91650781|NCT02462421|183194278|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.21||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.21
91650782|NCT02462421|183194278|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
91650783|NCT02462421|183194278|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.39||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Not corrected for multiple comparisons.||||0.39
91650784|NCT02891200|183194279|SUPERIORITY||Predicted Mean Difference|1.46||||0.467|TWO_SIDED|95.0|-2.47|5.38|||Mixed Models Analysis|Mixed effects linear model with study site and setting as fixed effects, and adjusted for baseline SGRQ domain scores.||||5.38|-2.47|0.467
91650785|NCT01339910|183194290|SUPERIORITY||Difference in 18 month OS (MAC-RIC)|9.8||||0.07|TWO_SIDED|95.0|-0.8|20.3||This final test was performed at a 0.049 significance level, since 0.001 was spent at interim analyses and the overall significance level was 0.050.|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in overall survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month overall survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||20.3|-0.8|0.07
91787570|NCT00412373|183454644|SUPERIORITY_OR_OTHER||LS Means Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.4|-1.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.2|-4.4|<0.001
91787571|NCT00412373|183454645|SUPERIORITY_OR_OTHER||LS Means Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.1|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.8|-3.1|<0.001
91787572|NCT00412373|183454646|SUPERIORITY_OR_OTHER||LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.3|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.3|-6.8|<0.001
91787573|NCT00412373|183454647|SUPERIORITY_OR_OTHER||LS Means Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.2|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.1|-4.2|<0.001
91650786|NCT01339910|183194291|SUPERIORITY||Difference in 18 month RFS (MAC-RIC)|20.4|||<|0.01|TWO_SIDED|95.0|8.9|32.0||Test performed at a significance level of 0.05|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in relapse-free survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month relapse-free survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||32.0|8.9|< 0.01
91650787|NCT01339910|183194292|SUPERIORITY||||||<|0.001||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of disease relapse during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of disease relapse was compared between treatment arms using Gray's test, treating death as a competing risk.||||< 0.001
91650788|NCT01339910|183194293|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of treatment-related mortality was compared between treatment arms using Gray's test, treating disease relapse as a competing risk.||||0.002
91650789|NCT01339910|183194294|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of neutrophil engraftment at Day 28 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.002
91650790|NCT01339910|183194294|SUPERIORITY|||||||0.065||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment at Day 60 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of platelet engraftment at Day 60 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.065
91650791|NCT01339910|183194295|SUPERIORITY|||||||0.005||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.005
91650792|NCT01339910|183194295|SUPERIORITY|||||||0.011||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 100 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.011
91650793|NCT01339910|183194295|SUPERIORITY|||||||0.39||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at 18 months post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.39
91650794|NCT01339910|183194296|SUPERIORITY|||||||0.024||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade II-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade II-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.024
91650795|NCT01339910|183194296|SUPERIORITY|||||||0.066||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade III-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade III-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.066
91709551|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.1837|TWO_SIDED|95.0|-0.302|0.058|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.058|-0.302|0.1837
91604101|NCT00619957|183100995|SUPERIORITY_OR_OTHER||LS Mean Difference|4.57|||<|0.0001|TWO_SIDED|95.0|3.49|5.66|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.66|3.49|<0.0001
91604102|NCT00619957|183100996|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1856|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||0.99|-0.19|0.1856
91604103|NCT00619957|183100997|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.0346|TWO_SIDED|95.0|0.05|1.25|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.25|0.05|0.0346
91604104|NCT00619957|183100998|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|0.98|2.41|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.41|0.98|<0.0001
91604105|NCT00619957|183100999|SUPERIORITY_OR_OTHER||LS Mean Difference|1.46|||<|0.0001|TWO_SIDED|95.0|0.76|2.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.17|0.76|<0.0001
91650796|NCT01339910|183194297|SUPERIORITY|||||||0.019||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of chronic GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.019
91650797|NCT02322879|183194305|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
91650798|NCT00810732|183194306|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.94|-0.19|||ANCOVA|||||-0.19|-0.94|0.0040
91523156|NCT03720938|182921803|SUPERIORITY|||||||0.638505||||||The outcome of self-perception for body attractiveness was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for body attractiveness at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.638505
91650799|NCT00810732|183194306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.0018|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||||-0.24|-0.99|0.0018
91650800|NCT00810732|183194306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.19||0.7945|TWO_SIDED|95.0|-0.33|0.43|||ANCOVA|||||0.43|-0.33|0.7945
91523157|NCT03720938|182921803|SUPERIORITY|||||||0.632||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.632
91650801|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.3||0.0087|TWO_SIDED|95.0|-6.08|-0.91|||ANCOVA|||Mean Systemic Arterial BP: Week 3||-0.91|-6.08|0.0087
91650802|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92|STANDARD_ERROR_OF_MEAN|1.3||0.1424|TWO_SIDED|95.0|-4.5|0.66|||ANCOVA|||Mean Systemic Arterial BP: Week 3||0.66|-4.50|0.1424
91650803|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.29||0.2277|TWO_SIDED|95.0|-4.15|1.0|||ANCOVA|||Mean Systemic Arterial BP: Week 3||1.00|-4.15|0.2277
91650804|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.81||0.1599|TWO_SIDED|95.0|-6.16|1.03|||ANCOVA|||Systolic Blood Pressure: Week 3||1.03|-6.16|0.1599
91650805|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|1.8||0.5545|TWO_SIDED|95.0|-4.66|2.52|||ANCOVA|||Systolic Blood Pressure: Week 3||2.52|-4.66|0.5545
91523158|NCT03720938|182921803|SUPERIORITY|||||||0.6328||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.63280
91604106|NCT00619957|183101000|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.2538|TWO_SIDED|95.0|-0.36|1.36|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.36|-0.36|0.2538
91604107|NCT00619957|183101001|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.0537|TWO_SIDED|95.0|-0.01|1.74|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.74|-0.01|0.0537
91604108|NCT00619957|183101002|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.0081|TWO_SIDED|95.0|0.32|2.15|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.15|0.32|0.0081
91604109|NCT00619957|183101003|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.0187|TWO_SIDED|95.0|0.18|1.94|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.94|0.18|0.0187
91650806|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|1.8||0.4095|TWO_SIDED|95.0|-5.08|2.09|||ANCOVA|||Systolic Blood Pressure: Week 3||2.09|-5.08|0.4095
91650807|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.08|STANDARD_ERROR_OF_MEAN|1.21||0.0012|TWO_SIDED|95.0|-6.49|-1.67|||ANCOVA|||Diastolic Blood Pressure: Week 3||-1.67|-6.49|0.0012
91650808|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.21||0.0159|TWO_SIDED|95.0|-5.38|-0.57|||ANCOVA|||Diastolic Blood Pressure: Week 3||-0.57|-5.38|0.0159
91650809|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.21||0.3627|TWO_SIDED|95.0|-3.51|1.3|||ANCOVA|||Diastolic Blood Pressure: Week 3||1.30|-3.51|0.3627
91709552|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.2896|TWO_SIDED|95.0|-0.293|0.088|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|||0.088|-0.293|0.2896
91604110|NCT00619957|183101004|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1408|TWO_SIDED|95.0|-0.19|1.34|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.34|-0.19|0.1408
91650810|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.36|STANDARD_ERROR_OF_MEAN|1.16||0.0057|TWO_SIDED|95.0|-5.69|-1.03|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-1.03|-5.69|0.0057
91650811|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.16||0.6503|TWO_SIDED|95.0|-2.86|1.8|||ANCOVA|||Mean Systemic Arterial BP: Week 6||1.80|-2.86|0.6503
91650812|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|1.16||0.0183|TWO_SIDED|95.0|-5.16|-0.5|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-0.50|-5.16|0.0183
91650813|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|1.53||0.0726|TWO_SIDED|95.0|-5.89|0.27|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.27|-5.89|0.0726
91650814|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|1.53||0.9661|TWO_SIDED|95.0|-3.01|3.14|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||3.14|-3.01|0.9661
91650815|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.88|STANDARD_ERROR_OF_MEAN|1.53||0.0656|TWO_SIDED|95.0|-5.94|0.19|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.19|-5.94|0.0656
91650816|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.16|STANDARD_ERROR_OF_MEAN|1.11||0.0068|TWO_SIDED|95.0|-5.39|-0.92|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||-0.92|-5.39|0.0068
91650817|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.11||0.376|TWO_SIDED|95.0|-3.22|1.24|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||1.24|-3.22|0.3760
91709553|NCT04378569|183311580|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.919|TWO_SIDED|95.0|-0.205|0.227|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.227|-0.205|0.9190
91523159|NCT03720938|182921804|SUPERIORITY|||||||0.007061||||||The outcome of self-perception of global physical self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global physical self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.007061
91650818|NCT00810732|183194307|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.16|STANDARD_ERROR_OF_MEAN|1.11||0.0572|TWO_SIDED|95.0|-4.4|0.07|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||0.07|-4.40|0.0572
91523160|NCT03720938|182921804|SUPERIORITY|||||||0.005||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.005
91650819|NCT00810732|183194308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8823|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Week 3||0.45|-0.39|0.8823
91604111|NCT00619957|183101005|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.0129|TWO_SIDED|95.0|0.23|1.92|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.92|0.23|0.0129
91787574|NCT00412373|183454648|SUPERIORITY_OR_OTHER||LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.3|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-3.3|<0.001
91604112|NCT00619957|183101006|SUPERIORITY_OR_OTHER||LS Mean Difference|2.31|||<|0.0001|TWO_SIDED|95.0|1.35|3.26|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.26|1.35|<0.0001
91604113|NCT00619957|183101007|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.0001|TWO_SIDED|95.0|1.22|3.08|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.08|1.22|<0.0001
91604114|NCT00619957|183101008|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|95.0|-51.52|-35.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-35.67|-51.52|<0.0001
91650820|NCT00810732|183194308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9457|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Week 3||0.43|-0.41|0.9457
91650821|NCT00810732|183194308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.9358|TWO_SIDED|95.0|-0.4|0.44|||ANCOVA|||Week 3||0.44|-0.40|0.9358
91787575|NCT00412373|183454649|SUPERIORITY_OR_OTHER||LS Means Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0|-2.9|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-2.9|<0.001
91604115|NCT00619957|183101009|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.72|||<|0.0001|TWO_SIDED|95.0|-58.01|-31.43|||ANOVA|Fixed effects for treatment and pooled center||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-31.43|-58.01|<0.0001
91604116|NCT00619957|183101010|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.33|||<|0.0001|TWO_SIDED|95.0|-55.99|-28.67|||ANOVA|Fixed effects for treatment and pooled centers.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-28.67|-55.99|<0.0001
91709554|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.4|1.3||||||Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.3|-4.4|
91523161|NCT03720938|182921804|SUPERIORITY|||||||0.00603||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.00603
91604117|NCT00619957|183101011|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.55|||<|0.0001|TWO_SIDED|95.0|-59.38|-33.72|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.72|-59.38|<0.0001
91604118|NCT00619957|183101012|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.15|||<|0.0001|TWO_SIDED|95.0|-57.01|-33.29|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.29|-57.01|<0.0001
91650822|NCT00810732|183194308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.0022|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 6||-0.25|-1.03|0.0022
91787576|NCT00412373|183454650|SUPERIORITY_OR_OTHER||LS Means Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.001||95.0|-2.6|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.6|-2.6|0.001
91787577|NCT00412373|183454651|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.016||95.0|-1.8|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-1.8|0.016
91604119|NCT00619957|183101013|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.88|||<|0.0001|TWO_SIDED|95.0|-23.43|-8.32|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-8.32|-23.43|<0.0001
91604120|NCT00619957|183101014|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-31.08|-12.91|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-12.91|-31.08|<0.0001
91650823|NCT00810732|183194308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8956|TWO_SIDED|95.0|-0.41|0.36|||ANCOVA|||Week 6||0.36|-0.41|0.8956
91650824|NCT00810732|183194308|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-1.0|-0.23|||ANCOVA|||Week 6||-0.23|-1.00|0.0030
91650825|NCT00124020|183194309|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|0.2||||||95.0|-6.8|7.2||p-values were not calculated in deference to confidence intervals.||||||7.2|-6.8|
91650826|NCT05117099|183194310|SUPERIORITY|||||||0.548|||||||ANOVA|||||||.548
91650827|NCT05117099|183194312|SUPERIORITY|||||||0.915|||||||ANOVA|||||||.915
91650828|NCT05117099|183194313|SUPERIORITY|||||||0.663|||||||ANOVA|||||||.663
91650829|NCT05117099|183194314|SUPERIORITY|||||||0.138|||||||ANOVA|||||||.138
91787578|NCT00412373|183454653|SUPERIORITY_OR_OTHER||LS Means Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1||0.002||95.0|-0.7|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-0.7|0.002
91650830|NCT05117099|183194315|SUPERIORITY|||||||0.114|||||||ANOVA|||||||.114
91650831|NCT05117099|183194316|SUPERIORITY|||||||0.065|||||||ANOVA|||||||.065
91650832|NCT05117099|183194317|SUPERIORITY|||||||0.394|||||||ANOVA|||||||.394
91650833|NCT05117099|183194318|SUPERIORITY|||||||0.388|||||||ANOVA|||||||.388
91650834|NCT05117099|183194319|SUPERIORITY|||||||0.332|||||||ANOVA|||||||.332
91650835|NCT05085613|183194329|SUPERIORITY||Mean Difference (Final Values)|0.6279928|STANDARD_ERROR_OF_MEAN|4.150369||0.998|TWO_SIDED|95.0|-9.463627|10.71961||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF=6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||10.71961|-9.463627|0.998
91650836|NCT05085613|183194329|SUPERIORITY||Mean Difference (Final Values)|4.044194|STANDARD_ERROR_OF_MEAN|4.302202||0.725|TWO_SIDED|95.0|-6.416608|14.505||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.505|-6.416608|0.725
91650837|NCT05085613|183194329|SUPERIORITY||Mean Difference (Final Values)|-1.53656|STANDARD_ERROR_OF_MEAN|-1.53656||0.98|TWO_SIDED|95.0|-12.25295|9.179834||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||9.179834|-12.25295|0.980
91787579|NCT00412373|183454654|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANOVA|P-value is from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.||||-0.3|-0.9|<0.001
91787580|NCT00412373|183454655|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.046
91787581|NCT00412373|183454657|SUPERIORITY_OR_OTHER||LS Means Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.4|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.7|-6.4|<0.001
91787582|NCT00412373|183454659|SUPERIORITY_OR_OTHER||LS Means Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.5||0.001||95.0|-7.7|-2.0|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.0|-7.7|0.001
91787583|NCT01478048|183454668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0923|TWO_SIDED|95.0|0.49|1.06||Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization|Log Rank|Adjusted alpha level= 0.30||||1.06|0.49|0.0923
91787584|NCT01478048|183454671|SUPERIORITY_OR_OTHER||Difference using Chan-Zhang method|2.3|||||TWO_SIDED|95.0|-13.2|17.8||||||||17.8|-13.2|
91787585|NCT01369329|183454677|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
91787586|NCT01369329|183454677|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
91787587|NCT01369329|183454678|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
91787588|NCT01369329|183454678|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
91787589|NCT01369329|183454679|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
91787590|NCT01369329|183454679|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
91787591|NCT01369329|183454680|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
91787592|NCT01369329|183454680|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
91787593|NCT01369329|183454681|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.009
91787594|NCT01369329|183454681|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
91787595|NCT03032380|183454682|NON_INFERIORITY|The study hypothesis was that the all-cause mortality rate at Day 14 in participants who received cefiderocol would be non-inferior to that in participants who received high-dose meropenem. The margin of non-inferiority was 12.5%. Non-inferiority was concluded if the upper bound of the 2-sided 95% confidence interval for the difference in mortality at Day 14 between the 2 treatment groups (cefiderocol - meropenem) was smaller than 12.5%.|Treatment Difference|0.8||||0.002|TWO_SIDED|95.0|-6.6|8.2|||Cochran-Mantel-Haenszel||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 14 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||8.2|-6.6|0.0020
91787596|NCT03032380|183454683|SUPERIORITY||Treatment Difference|-1.4|||||TWO_SIDED|95.0|-13.5|10.7|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the eradication rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.7|-13.5|
91787597|NCT03032380|183454684|SUPERIORITY||Treatment Difference|-2.0|||||TWO_SIDED|95.0|-12.5|8.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.5|-12.5|
91787598|NCT03032380|183454685|OTHER||Treatment Difference|-0.3|||||TWO_SIDED|95.0|-8.8|8.2|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.2|-8.8|
91787599|NCT03032380|183454686|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-12.8|5.1|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||5.1|-12.8|
91787600|NCT03032380|183454687|OTHER||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.8|-10.9|
91523162|NCT03720938|182921805|SUPERIORITY|||||||0.002879||||||The outcome of self-perception for global self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002879
91523163|NCT03720938|182921805|SUPERIORITY|||||||0.002||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002
91523164|NCT03720938|182921805|SUPERIORITY|||||||0.00238||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.00238
91523165|NCT03720938|182921806|SUPERIORITY|||||||0.194||||||Tested the significance of gender between genders|Wilcoxon (Mann-Whitney)|||"Enjoyment scale of physical activity sports in intervention group between male and female genders"||||0.194
91604121|NCT00619957|183101015|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.96|||<|0.0001|TWO_SIDED|95.0|-30.75|-13.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-13.17|-30.75|<0.0001
91650838|NCT05085613|183194330|SUPERIORITY||Mean Difference (Final Values)|7.002255|STANDARD_ERROR_OF_MEAN|8.801527||0.813|TWO_SIDED|95.0|-14.39448|28.39899||Sidak's adjusted p-value for multiple comparisons|ANCOVA|Df = 6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||28.39899|-14.39448|0.813
91787601|NCT03032380|183454688|OTHER||Treatment Difference|-12.4|||||TWO_SIDED|95.0|-24.4|-0.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||-0.5|-24.4|
91790760|NCT02880956|183460080|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790761|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.902||0.148|TWO_SIDED|95.0|-3.08|0.465||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.465|-3.080|0.148
91790762|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|6.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91523166|NCT03720938|182921807|SUPERIORITY|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the Active video game group for the variable of enjoyment from sports category.||||0.809
91604122|NCT00619957|183101016|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.11||||0.0012|TWO_SIDED|95.0|-24.2|-6.02|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-6.02|-24.20|0.0012
91787602|NCT03032380|183454689|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-15.5|7.9|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||7.9|-15.5|
91787603|NCT03032380|183454690|OTHER||Treatment Difference|3.9|||||TWO_SIDED|95.0|-7.9|15.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||15.8|-7.9|
91787604|NCT03032380|183454691|OTHER||Treatment Difference|0.5|||||TWO_SIDED|95.0|-8.7|9.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 28 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||9.8|-8.7|
91787605|NCT03032380|183454692|OTHER||Treatment Difference|3.6|||||TWO_SIDED|95.0|-6.3|13.4|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at EOS based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||13.4|-6.3|
91787606|NCT03032380|183454693|SUPERIORITY|||||||0.9382|||||||t-test, 2 sided|||Comparison of Hospitalization time at test of cure||||0.9382
91787607|NCT03032380|183454693|SUPERIORITY|||||||0.6552|||||||t-test, 2 sided|||Comparison of hospitalization time at follow-up||||0.6552
91787608|NCT02937584|183454695|OTHER||Geometric mean ratio to baseline|1.11||||0.0187|TWO_SIDED|95.0|1.02|1.22||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.22|1.02|0.0187
91787609|NCT02937584|183454695|OTHER||Geometric mean ratio to baseline|1.23|||<|0.0001|TWO_SIDED|95.0|1.14|1.33||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.33|1.14|<0.0001
91787610|NCT02937584|183454696|OTHER||Geometric mean ratio to baseline|0.75||||0.0219|TWO_SIDED|95.0|0.59|0.95||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.95|0.59|0.0219
91787611|NCT02937584|183454696|OTHER||Geometric mean ratio to baseline|0.56|||<|0.0001|TWO_SIDED|95.0|0.44|0.71||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.71|0.44|<0.0001
91787612|NCT02937584|183454697|OTHER||Geometric mean ratio to baseline|1.12||||0.0283|TWO_SIDED|95.0|1.01|1.24|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.24|1.01|0.0283
91787613|NCT02937584|183454697|OTHER||Geometric mean ratio to baseline|1.21|||<|0.0001|TWO_SIDED|95.0|1.12|1.31|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.31|1.12|<0.0001
91787614|NCT02937584|183454698|OTHER||Geometric mean ratio to baseline|0.76||||0.0304|TWO_SIDED|95.0|0.59|0.97|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.97|0.59|0.0304
91787615|NCT02937584|183454698|OTHER||Geometric mean ratio to baseline|0.55||||0.0003|TWO_SIDED|95.0|0.41|0.72|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.72|0.41|0.0003
91787616|NCT02937584|183454699|OTHER||Mean Change from Baseline|0.065||||0.1582|TWO_SIDED|95.0|-0.028|0.158|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.158|-0.028|0.1582
91787617|NCT02937584|183454699|OTHER||Mean Change from Baseline|0.151||||0.0375|TWO_SIDED|95.0|0.01|0.292|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.292|0.010|0.0375
91787618|NCT02937584|183454700|OTHER||Geometric mean ratio to baseline|0.978||||0.6176|TWO_SIDED|95.0|0.891|1.073|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.073|0.891|0.6176
91787619|NCT02937584|183454700|OTHER||Geometric mean ratio to baseline|0.938||||0.2699|TWO_SIDED|95.0|0.833|1.056|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.056|0.833|0.2699
91787620|NCT00796445|183454713|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.|Hazard Ratio (HR)|1.013||||0.8566|TWO_SIDED|95.0|0.879|1.169|||Regression, Cox|||At Final analysis (Month 30)||1.169|0.879|0.8566
91787621|NCT00796445|183454713|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.111||||0.4821|TWO_SIDED|95.0|0.828|1.491|||Regression, Cox|||At Final analysis (Month 30)||1.491|0.828|0.4821
91787622|NCT00796445|183454713|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature|Hazard Ratio (HR)|0.915||||0.5375|TWO_SIDED|95.0|0.691|1.212|||Regression, Cox|||At Final analysis (Month 30)||1.212|0.691|0.5375
91787623|NCT00796445|183454714|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement|Hazard Ratio (HR)|1.023||||0.7534|TWO_SIDED|95.0|0.89|1.175|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.175|0.890|0.7534
91787624|NCT00796445|183454714|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.094||||0.5385|TWO_SIDED|95.0|0.821|1.457|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.457|0.821|0.5385
91523167|NCT03720938|182921808|SUPERIORITY|||||||0.843|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from balance category.||||0.843
91523168|NCT03720938|182921809|SUPERIORITY|||||||0.247|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from aerobic category.||||0.247
91523169|NCT03720938|182921810|SUPERIORITY|||||||0.543|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from training category.||||0.543
91650839|NCT05085613|183194330|SUPERIORITY||Mean Difference (Final Values)|15.12214|STANDARD_ERROR_OF_MEAN|9.07444||0.268|TWO_SIDED|95.0|-6.938055|37.18234||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.18234|-6.938055|0.268
91650840|NCT05085613|183194330|SUPERIORITY||Mean Difference (Final Values)|14.4032|STANDARD_ERROR_OF_MEAN|9.305576||0.33|TWO_SIDED|95.0|-8.218891|37.0253||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.0253|-8.218891|0.330
91650841|NCT05085613|183194331|SUPERIORITY||Mean Difference (Final Values)|-1.457003|STANDARD_ERROR_OF_MEAN|6.380984||0.994|TWO_SIDED|95.0|-16.98852|14.07451||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.07451|-16.98852|0.994
91650842|NCT05085613|183194331|SUPERIORITY||Mean Difference (Final Values)|-1.097586|STANDARD_ERROR_OF_MEAN|6.675066||0.998|TWO_SIDED|95.0|-17.34491|15.14973||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||15.14973|-17.34491|0.998
91523170|NCT00499863|182921833|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The null hypothesis was that there is no difference between MTS and placebo.||||< 0.001
91650843|NCT05085613|183194331|SUPERIORITY||Mean Difference (Final Values)|8.926191|STANDARD_ERROR_OF_MEAN|6.588643||0.447|TWO_SIDED|95.0|-7.110771|24.96315||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||24.96315|-7.110771|0.447
91523171|NCT00499863|182921834|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
91523172|NCT00499863|182921835|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91523173|NCT00499863|182921836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91604123|NCT00619957|183101017|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.37||||0.0003|TWO_SIDED|95.0|-25.24|-7.49|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-7.49|-25.24|0.0003
91604124|NCT00619957|183101018|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.29|-11.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-11.99|-19.29|<0.0001
91650844|NCT05085613|183194332|SUPERIORITY||Mean Difference (Final Values)|-4.154612|STANDARD_ERROR_OF_MEAN|1.986723||0.113|TWO_SIDED|95.0|-8.985328|0.6761041||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||.6761041|-8.985328|0.113
91650845|NCT05085613|183194332|SUPERIORITY||Mean Difference (Final Values)|-2.685896|STANDARD_ERROR_OF_MEAN|2.046067||0.473|TWO_SIDED|95.0|-7.6609|2.289114||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||2.289114|-7.66090|0.473
91523174|NCT00499863|182921837|SUPERIORITY_OR_OTHER|||||||0.288||95.0|||||ANCOVA|||||||0.288
91523175|NCT00571701|182921845|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91523176|NCT00571701|182921846|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
91650846|NCT05085613|183194332|SUPERIORITY||Mean Difference (Final Values)|-6.469932|STANDARD_ERROR_OF_MEAN|2.102231||0.008|TWO_SIDED|95.0|-11.58151|-1.358358||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||-1.358358|-11.58151|0.008
91523177|NCT00571701|182921847|SUPERIORITY_OR_OTHER||||||>|0.3||||||Adjusted for multiple comparisons|Fisher Exact|||||||>0.3
91604125|NCT00619957|183101019|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-25.61|-16.59|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.59|-25.61|<0.0001
91604126|NCT00619957|183101020|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.39|||<|0.0001|TWO_SIDED|95.0|-27.8|-16.98|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.98|-27.80|<0.0001
91604127|NCT00619957|183101021|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.15|||<|0.0001|TWO_SIDED|95.0|-39.84|-16.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.47|-39.84|<0.0001
91604128|NCT00619957|183101022|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-37.63|-16.87|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.87|-37.63|<0.0001
91604129|NCT00619957|183101023|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.8794|TWO_SIDED|95.0|-1.99|1.71|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.71|-1.99|0.8794
91604130|NCT00619957|183101024|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47||||0.6658|TWO_SIDED|95.0|-2.62|1.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.67|-2.62|0.6658
91650847|NCT00602030|183194380|SUPERIORITY||Adjusted Odds Ratio|0.72||||0.505|TWO_SIDED|95.0|0.27|1.89|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel estimation of odds ratio adjusted for the smoking history stratification factor, using placebo as reference group.|||1.89|0.27|0.505
91650848|NCT00602030|183194381|SUPERIORITY||Adjusted Odds Ratio|0.31||||0.13|TWO_SIDED|95.0|0.06|1.54|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group .|||1.54|0.06|0.13
91650849|NCT00602030|183194382|SUPERIORITY||Adjusted Odds Ratio|1.06||||0.918|TWO_SIDED|95.0|0.34|3.27|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group.|||3.27|0.34|0.918
91650850|NCT00397839|183194422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.58|||<|0.001||95.0|1.41|3.76|||ANCOVA|||||3.76|1.41|<0.001
91523178|NCT00571701|182921848|SUPERIORITY_OR_OTHER|||||||1||||||Adjusted for multiple comparisons|Fisher Exact|||||||1.00
91523179|NCT00571701|182921849|SUPERIORITY_OR_OTHER||||||>|0.5||||||Adjusted for multiple comparisons|Fisher Exact|||||||> 0.5
91523180|NCT00571701|182921850|SUPERIORITY_OR_OTHER||||||>|0.56|||||||t-test, 2 sided|||||||>0.56
91523181|NCT00691132|182921853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.023|TWO_SIDED|95.0|-13.8|-1.2|||Mixed Models Analysis|||% difference between Placebo and PEITC periods in the ratio of \[pyridine-D4\]Hydroxy acid : \[pyridine-D4\] total NNAL||-1.2|-13.8|0.023
91523182|NCT00691132|182921854|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||Total ITC||||0.005
91523183|NCT00691132|182921856|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANOVA|||Total ITC||||0.017
91523184|NCT00691132|182921857|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||0.039
91523185|NCT00691132|182921857|SUPERIORITY_OR_OTHER|||||||0.623|||||||Mixed Models Analysis|||||||0.623
91523186|NCT00691132|182921857|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||||||0.045
91604131|NCT00619957|183101025|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.784|TWO_SIDED|95.0|-2.39|1.81|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.81|-2.39|0.7840
91650851|NCT00397839|183194423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.118||95.0|-0.22|1.94|||ANCOVA|||||1.94|-0.22|0.118
91650852|NCT00397839|183194424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|||<|0.001||95.0|1.34|2.92|||ANCOVA|||Total Hip subgroup||2.92|1.34|<0.001
91650853|NCT00397839|183194424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.43||||0.012||95.0|0.32|2.55|||ANCOVA|||Femoral Neckm subgroup||2.55|0.32|0.012
91650854|NCT00397839|183194424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72||||0.004||95.0|0.56|2.88|||ANCOVA|||Trochanter subgroup||2.88|0.56|0.004
91650855|NCT00397839|183194425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75|||<|0.001||95.0|1.11|2.4|||ANCOVA|||Total Hip subgroup||2.40|1.11|<0.001
91650856|NCT00397839|183194425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Femoral Neck subgroup||2.25|0.11|0.031
91650857|NCT00397839|183194425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Trochanter subgroup||2.25|0.11|0.031
91650858|NCT00397839|183194426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.362||95.0|0.73|1.13|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 6||1.13|0.73|0.362
91650859|NCT00397839|183194426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.044||95.0|0.72|1.01|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 12||1.01|0.72|0.044
91650860|NCT00397839|183194426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||<|0.001||95.0|0.3|0.72|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 6||0.72|0.30|<0.001
91650861|NCT00397839|183194426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|||<|0.001||95.0|0.41|0.8|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 12||0.80|0.41|<0.001
91650862|NCT00397839|183194426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.001||95.0|0.23|0.72|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD at Month 6||0.72|0.23|<0.001
91650863|NCT00397839|183194426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001||95.0|0.33|0.75|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD||0.75|0.33|<0.001
91650864|NCT02151461|183194427|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in plasma glucose AUC(0-3hr) at Week 4 in the Day 28 Evaluable population. The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.0435||||||Baseline plasma glucose AUC(0-3hr) is adjusted as a covariate.|ANCOVA|||||||0.0435
91650865|NCT02151461|183194427|OTHER|||||||0.065|||||||ANCOVA|||||||0.065
91650866|NCT02151461|183194427|OTHER|||||||0.1216|||||||ANCOVA|||||||0.1216
91650867|NCT02151461|183194428|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in incremental plasma glucose AUC at Week 4 in the Day 28 Evaluable population. The model will include factors for treatment group and fasting plasma glucose stratum.||||||0.8867|||||||ANCOVA|The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.8867
91650868|NCT02151461|183194428|OTHER|||||||0.7641|||||||ANCOVA|||||||0.7641
91787625|NCT00796445|183454714|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.|Hazard Ratio (HR)|0.918||||0.5419|TWO_SIDED|95.0|0.698|1.207|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.207|0.698|0.5419
91787626|NCT01433289|183454763|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||The study hypothesis tested whether Polyphenon E given twice daily for 14 days at the specified doses has an effect on antiviral activity compared with placebo, measured by differences from baseline to day 14 in plasma HIV-1 RNA level (log10 copies/mL). The Wilcoxon signed-rank test was used to test the null hypothesis that there was no change at Day 14 versus baseline.||||>0.05
91787627|NCT01433289|183454763|SUPERIORITY|||||||0.74||||||Analysis was stratified by treatment group. The Kruskal-Wallis test was used to compare the change of log10 HIV-1 RNA copies/ml between treatment groups.|Kruskal-Wallis|||||||0.74
91787628|NCT00783198|183454796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||0.0039|TWO_SIDED|95.0|-2.95|-0.57|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.57|-2.95|0.0039
91787629|NCT00783198|183454796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24||||0.0002|TWO_SIDED|95.0|-3.41|-1.07|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-1.07|-3.41|0.0002
91787630|NCT00783198|183454797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.032|TWO_SIDED|95.0|-2.08|-0.09|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.09|-2.08|0.0320
91787631|NCT00783198|183454797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.78|-0.82|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.82|-2.78|0.0003
91787632|NCT00783198|183454798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0472|TWO_SIDED|95.0|-1.54|-0.01|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.01|-1.54|0.0472
91787633|NCT00783198|183454798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0144|TWO_SIDED|95.0|-1.7|-0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.19|-1.70|0.0144
91787634|NCT00783198|183454799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.1686|TWO_SIDED|95.0|-1.11|0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.19|-1.11|0.1686
91650869|NCT02151461|183194428|OTHER|||||||0.2518|||||||ANCOVA|||||||0.2518
91787635|NCT00783198|183454799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0125|TWO_SIDED|95.0|-1.46|-0.18|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.18|-1.46|0.0125
91650870|NCT02151461|183194429|OTHER|||||||0.0179|||||||ANCOVA|Total daily dose is twice the respective dose, Pairwise comparison using Treatment D as the reference group||||||0.0179
91787636|NCT00783198|183454800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0039|TWO_SIDED|95.0|-1.65|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.65|0.0039
91787637|NCT00783198|183454800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0001|TWO_SIDED|95.0|-1.95|-0.64|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.64|-1.95|0.0001
91787638|NCT01134705|183454812|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.2|-0.5||A priori threshold for statistical significance is p\<0.05|Repeated measures Analysis of covariance|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.2|<0.001
91787639|NCT01134705|183454813|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||A priori threshold for statistical significance is p\<0.05|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
91787640|NCT01134705|183454814|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.001|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|ANCOVA with treatment, baseline and center in the model.||||-0.2|-0.9|0.001
91787641|NCT00101452|183454824|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91787642|NCT01510769|183454825|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.1298|TWO_SIDED|95.0|-0.03|0.23|||Cochran-Mantel-Haenszel|||||0.23|-0.03|0.1298
91787643|NCT01510769|183454825|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.29|||<|0.0001|TWO_SIDED|95.0|0.17|0.42|||Cochran-Mantel-Haenszel|||||0.42|0.17|<0.0001
91787644|NCT01510769|183454826|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.04||||0.4453|TWO_SIDED|95.0|-0.07|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.07|0.4453
91787645|NCT01510769|183454826|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.1149|TWO_SIDED|95.0|-0.02|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.02|0.1149
91787646|NCT01510769|183454827|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.03||||0.645|TWO_SIDED|95.0|-0.1|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.10|0.6450
91604132|NCT00619957|183101026|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Controlled for pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||||<0.0001
91604133|NCT00619957|183101027|SUPERIORITY_OR_OTHER||Relative Risk|0.771||||0.7284||95.0|0.184|3.226|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.226|0.184|0.7284
91604134|NCT00619957|183101028|SUPERIORITY_OR_OTHER||Relative Risk|0.688||||0.5293|TWO_SIDED|95.0|0.245|1.932|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.932|0.245|0.5293
91604135|NCT00723957|183101029|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04|||||ONE_SIDED|90.0||1.41|||Regression, Cox|||||1.41||
91604136|NCT00723957|183101029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5735|||||||Log Rank|||P-value is 1-sided||||0.5735
91604137|NCT00723957|183101030|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||ONE_SIDED|90.0||1.1|||Regression, Cox|||||1.10||
91604138|NCT00723957|183101030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Log Rank|||P-value is 1-sided||||0.1750
91604139|NCT00723957|183101031|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||ONE_SIDED|90.0||1.15|||Regression, Cox|||||1.15||
91787647|NCT01510769|183454827|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.06||||0.4118|TWO_SIDED|95.0|-0.08|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.08|0.4118
91787648|NCT01510769|183454828|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.3034|TWO_SIDED|95.0|-0.24|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.24|0.3034
91604140|NCT00723957|183101031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.316|ONE_SIDED||||||Log Rank|||P-value is 1-sided||||0.316
91787649|NCT01510769|183454828|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19||||0.021|TWO_SIDED|95.0|-0.34|-0.04|||Cochran-Mantel-Haenszel|||||-0.04|-0.34|0.0210
91604141|NCT00723957|183101037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||ONE_SIDED|90.0||2.1|||Regression, Cox||β3T+ subgroup|||2.10||
91604142|NCT00723957|183101037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||0.9|||Regression, Cox||β3T- subgroup|||0.90||
91604143|NCT00723957|183101037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||ONE_SIDED|90.0||1.4|||Regression, Cox||Overall population|||1.40||
91604144|NCT01763164|183101038|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log-rank test.||0.80|0.47|< 0.001
91604145|NCT01763164|183101039|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.499|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log rank test.||1.33|0.75|0.499
91604146|NCT01763164|183101040|SUPERIORITY|||||||0.015|||||||Cochran-Mantel-Haenszel|||Confirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.015
91604147|NCT01763164|183101040|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||Confirmed ORR + Unconfirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.002
91604148|NCT01763164|183101053|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.96|2.13|||Log Rank|||||2.13|0.96|
91604149|NCT01763164|183101056|SUPERIORITY||Hazard Ratio (HR)|2.2||||0.995|TWO_SIDED|95.0|1.19|4.06|||Log Rank|||Log-rank test and Cox PH model were stratified by American joint committee on cancer stage, prior line immunotherapy and ECOG performance status. P-value was one tailed and was based on the log-rank score test. Hazard ratio and 95% CI was based on a Wald test from Cox model.||4.06|1.19|0.995
91604150|NCT01264939|183101059|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.52|||<|0.0001|TWO_SIDED|95.0|-5.97|-3.08||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.08|-5.97|<0.0001
91787650|NCT02874144|183454849|SUPERIORITY|intention-to-treat with participants analyzed according to a randomly assigned treatment group irrespective of compliance.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Regression, Linear|||We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time compare relative rate of change over time between scores within the treatment group (AZD1981 plus INCS) and within the to scores within the placebo group (INCS treatment only)..|For inflammatory mediator analyses, data were reported as mean (SEM) with statistical significance determined by Kruskal-Wallis test.|||<0.05
91650871|NCT02151461|183194429|OTHER|||||||0.0736|||||||ANCOVA|||||||0.0736
91650872|NCT02151461|183194429|OTHER|||||||0.0475|||||||ANCOVA|||||||0.0475
91650873|NCT02151461|183194430|OTHER|||||||0.0089|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||||||0.0089
91650874|NCT02151461|183194430|OTHER|||||||0.376|||||||ANCOVA|||||||0.376
91650875|NCT02151461|183194430|OTHER|||||||0.0578|||||||ANCOVA|||||||0.0578
91604151|NCT01264939|183101060|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.02|||<|0.0001|TWO_SIDED|95.0|-13.17|-6.86||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-6.86|-13.17|<0.0001
91790763|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.896||0.092|TWO_SIDED|95.0|-3.278|0.246||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.246|-3.278|0.092
91790764|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|7.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790765|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.915||0.073|TWO_SIDED|95.0|-3.446|0.152||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.152|-3.446|0.073
91790766|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|6.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790767|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|0.47|STANDARD_ERROR_OF_MEAN|1.081||0.662|TWO_SIDED|95.0|-1.652|2.599||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.599|-1.652|0.662
91790768|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|8.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790769|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.057||0.992|TWO_SIDED|95.0|-2.089|2.068||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.068|-2.089|0.992
91790770|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|8.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790771|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-0.82|STANDARD_ERROR_OF_MEAN|1.088||0.451|TWO_SIDED|95.0|-2.961|1.32||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.320|-2.961|0.451
91790772|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|7.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790773|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.227||0.583|TWO_SIDED|95.0|-3.088|1.739||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.739|-3.088|0.583
91790774|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|8.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790775|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-1.59|STANDARD_ERROR_OF_MEAN|1.213||0.191|TWO_SIDED|95.0|-3.975|0.795||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.795|-3.975|0.191
91790776|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|9.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790777|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.238||0.372|TWO_SIDED|95.0|-3.541|1.329|||repeated measures model|||Week 72||1.329|-3.541|0.372
91790778|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|8.96|||TWO_SIDED|||||||||Week 72||||
91790779|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|1.303||0.447|TWO_SIDED|95.0|-3.553|1.571||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.571|-3.553|0.447
91790780|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|9.35|||TWO_SIDED|||||||||Week 96||||
91790781|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|1.285||0.881|TWO_SIDED|95.0|-2.334|2.719||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.719|-2.334|0.881
91790782|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|8.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790783|NCT02880956|183460081|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|1.338||0.853|TWO_SIDED|95.0|-2.881|2.383||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.383|-2.881|0.853
91790784|NCT02880956|183460081|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|8.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91709555|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.2|0.1||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.1|-6.2|
91790785|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.846||0.287|TWO_SIDED|95.0|-2.567|0.762||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.762|-2.567|0.287
91523187|NCT04037436|182921955|OTHER|GEE|GEE|1.65||||0.05|TWO_SIDED|95.0|-4.44|7.73|||GEE|To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||7.73|-4.44|0.05
91523188|NCT01859793|182921966|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.||||<0.05
91604152|NCT01264939|183101061|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.72|-4.07||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.07|-7.72|<0.0001
91604153|NCT01264939|183101062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99|||<|0.0001|TWO_SIDED|95.0|1.47|2.68||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||2.68|1.47|<0.0001
91790786|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|6.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790787|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.838||0.227|TWO_SIDED|95.0|-2.661|0.633||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.633|-2.661|0.227
91790788|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790789|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.859||0.241|TWO_SIDED|95.0|-2.698|0.681||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.681|-2.698|0.241
91790790|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|6.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790791|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|0.958||0.397|TWO_SIDED|95.0|-1.073|2.696||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.696|-1.073|0.397
91790792|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|7.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790793|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.936||0.671|TWO_SIDED|95.0|-2.239|1.443||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.443|-2.239|0.671
91790794|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|7.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790795|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.964||0.231|TWO_SIDED|95.0|-3.052|0.738||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.738|-3.052|0.231
91790796|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790797|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|2.47|STANDARD_ERROR_OF_MEAN|1.137||0.031|TWO_SIDED|95.0|0.23|4.701||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||4.701|0.230|0.031
91790798|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|0.29|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91604154|NCT01264939|183101063|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91604155|NCT01264939|183101064|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91604156|NCT01264939|183101065|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.25|-3.96||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.96|-7.25|<0.0001
91604157|NCT01264939|183101066|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|||<|0.0001|TWO_SIDED|95.0|-6.28|-3.06||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.06|-6.28|<0.0001
91604158|NCT01264939|183101067|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||0.0006
91604159|NCT01264939|183101068|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91604160|NCT01171612|183101101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.479|TWO_SIDED|95.0|0.513|2.299|||Chi-squared|||Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery||2.299|0.513|0.479
91604161|NCT01171612|183101101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.638||||0.479|TWO_SIDED|95.0|0.733|3.662|||Chi-squared|||||3.662|0.733|0.479
91604162|NCT00565617|183101104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
91604163|NCT01173653|183101119|SUPERIORITY_OR_OTHER||Chi square|23.02|||<|0.05|||||||Chi-squared|||||||<0.05
91604164|NCT00125034|183101120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.516||||0.064|TWO_SIDED|95.0|0.975|2.335|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 \& 50% under FOLFOX-4 alone for the stratum with ECOG PS0-1 \& 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%||2.335|0.975|0.064
91604165|NCT00125034|183101121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.551||||0.0027|TWO_SIDED|95.0|1.38|4.717|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||4.717|1.380|0.0027
91604166|NCT00125034|183101122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.459||||0.029|TWO_SIDED|95.0|0.228|0.924|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||0.924|0.228|0.0290
91604167|NCT00125034|183101123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.931||||0.617|TWO_SIDED|95.0|0.705|1.23|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.230|0.705|0.6170
91650876|NCT02151461|183194431|OTHER|||||||0.2177|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||The HOMA Calculator,is an algorithm that takes account of variations in hepatic and peripheral glucose resistance, increases in insulin secretion curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and contribution of circulating proinsulin (eg, C-peptide) to estimate steady state beta cell function (%HOMA-B) and insulin sensitivity (%HOMA-S), as percentages of a normal reference population. %HOMA-IR was analyzed on a logarithmic scale (natural logarithmic transformation).||||0.2177
91650877|NCT02151461|183194431|OTHER|||||||0.4144|||||||ANCOVA|||||||0.4144
91650878|NCT02151461|183194431|OTHER|||||||0.3117|||||||ANCOVA|||||||0.3117
91650879|NCT02151461|183194432|OTHER|Average Change in Pre-meal Glucose Level||||||0.011|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.011
91604168|NCT00125034|183101124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.567||||0.0064|TWO_SIDED|95.0|0.375|0.856|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.856|0.375|0.0064
91604169|NCT00125034|183101125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.0153|TWO_SIDED|95.0|1.104|2.679|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||2.679|1.104|0.0153
91604170|NCT00125034|183101126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.905|TWO_SIDED|95.0|0.791|1.303|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.303|0.791|0.9050
91604171|NCT00125034|183101127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3854|TWO_SIDED|95.0|0.599|1.219|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.219|0.599|0.3854
91604172|NCT00125034|183101128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2004|TWO_SIDED|95.0|0.873|1.906|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.906|0.873|0.2004
91604173|NCT03529409|183101142|SUPERIORITY||Mean Difference (Net)|-0.287||||0.01|TWO_SIDED|95.0|-0.507|-0.066|||Mixed Models Analysis|||||-.066|-.507|.01
91604174|NCT03529409|183101143|SUPERIORITY||Mean Difference (Net)|1.95||||0.28|TWO_SIDED|95.0|-1.61|5.5||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||5.50|-1.61|.28
91604175|NCT03529409|183101144|SUPERIORITY||Mean Difference (Net)|157.0||||0.16|TWO_SIDED|95.0|-67.0|382.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||382|-67|.16
91604176|NCT03529409|183101145|SUPERIORITY||Mean Difference (Net)|0.25||||0.77|TWO_SIDED|95.0|-1.51|2.0||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||2.00|-1.51|.77
91604177|NCT03529409|183101146|SUPERIORITY||Mean Difference (Net)|0.71||||0.63|TWO_SIDED|95.0|-2.24|3.67||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||3.67|-2.24|.63
91604178|NCT03529409|183101147|SUPERIORITY||Mean Difference (Net)|84.0||||0.44|TWO_SIDED|95.0|-136.0|304.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||304|-136|.44
91604179|NCT03529409|183101148|SUPERIORITY||Mean Difference (Net)|-0.16||||0.87|TWO_SIDED|95.0|-1.85|1.58||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.58|-1.85|.87
91650880|NCT02151461|183194432|OTHER|Average Change in Pre-meal Glucose Level||||||0.0152|||||||ANCOVA|||||||0.0152
91650881|NCT02151461|183194432|OTHER|Average Change in Pre-meal Glucose Level||||||0.0284|||||||ANCOVA|||||||0.0284
91604180|NCT03529409|183101153|SUPERIORITY||Mean Difference (Net)|-0.47||||0.65|TWO_SIDED|95.0|-2.49|1.55||The overall omnibus test of the time by treatment interaction was p=.89. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.55|-2.49|.65
91650882|NCT02151461|183194432|OTHER|Average Change in Post-meal Glucose Level||||||0.1273|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.1273
91650883|NCT02151461|183194432|OTHER|Average Change in Post-meal Glucose Level||||||0.0085|||||||ANCOVA|||||||0.0085
91650884|NCT02151461|183194432|OTHER|Average Change in Post-meal Glucose Level||||||0.1289|||||||ANCOVA|||||||0.1289
91650885|NCT02151461|183194433|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.3143|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise comparison using Treatment D as the reference group.||||||0.3143
91650886|NCT02151461|183194433|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.5677|||||||ANCOVA|||||||0.5677
91790799|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|0.68|STANDARD_ERROR_OF_MEAN|1.124||0.547|TWO_SIDED|95.0|-1.532|2.888||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.888|-1.532|0.547
91523189|NCT01859793|182921967|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
91604181|NCT03529409|183101154|SUPERIORITY||Mean Difference (Net)|3.3||||0.63|TWO_SIDED|95.0|-10.5|17.1||The overall omnibus test of the time by treatment interaction was p=.66. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||17.1|-10.5|.63
91604182|NCT03529409|183101155|SUPERIORITY||Mean Difference (Net)|-0.03||||0.85|TWO_SIDED|95.0|-0.34|0.28||The overall omnibus test of the time by treatment interaction was p=.94. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||.28|-.34|.85
91604183|NCT03430986|183101161|SUPERIORITY||Least Squares (LS) Mean Difference|2.037|STANDARD_ERROR_OF_MEAN|0.1578|<|0.0001|TWO_SIDED|95.0|1.726|2.349|||MMRM|MMRM included treatment, timepoint, treatment-by-timepoint interaction as fixed effect using an unstructured covariance matrix.||||2.349|1.726|<0.0001
91604184|NCT03430986|183101162|SUPERIORITY||Percentage difference|68.4|||<|0.0001|TWO_SIDED|95.0|50.0|82.4|||Fisher Exact|2-sided test comparing responder rate between treatment group and control group.||||82.4|50.0|<0.0001
91650887|NCT02151461|183194433|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.8407|||||||ANCOVA|||||||0.8407
91650888|NCT02151461|183194434|OTHER|||||||0.9789|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.9789
91650889|NCT02151461|183194434|OTHER|||||||0.841|||||||ANCOVA|||||||0.841
91650890|NCT02151461|183194434|OTHER|||||||0.748|||||||ANCOVA|||||||0.748
91650891|NCT02191579|183194466|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.681|9.085||Odds ratio, 95% CI, and p-value were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||9.085|2.681|<0.001
91650892|NCT02191579|183194467|SUPERIORITY||Mean Difference (Net)|-6.199|||<|0.001|TWO_SIDED|95.0|-7.936|-4.462||Estimated mean difference, 95% CI, and p-value were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-4.462|-7.936|<0.001
91650893|NCT02191579|183194468|SUPERIORITY||Median Difference (Net)|-4.248|||<|0.001||95.0|-5.766|-2.731||Estimated mean difference, 95% CI, and p-value for Week 30 were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-2.731|-5.766|<0.001
91650894|NCT02191579|183194469|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001||95.0|2.014|8.157||Odds ratio, 95% CI, and p-value for the Week 29-32 interval were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||8.157|2.014|<0.001
91650895|NCT01086215|183194496|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
91650896|NCT01086215|183194496|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
91650897|NCT01086215|183194496|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
91650898|NCT01086215|183194496|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
91790800|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|9.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790801|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|0.73|STANDARD_ERROR_OF_MEAN|1.145||0.524|TWO_SIDED|95.0|-1.521|2.984||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.984|-1.521|0.524
91790802|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|8.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790803|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.356||0.54|TWO_SIDED|95.0|-3.499|1.836||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.836|-3.499|0.540
91790804|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|10.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790805|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.336||0.664|TWO_SIDED|95.0|-3.208|2.046||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.046|-3.208|0.664
91604185|NCT01412957|183101183|SUPERIORITY_OR_OTHER||Normal score|-2.59||||0.0096|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.||||0.0096
91604186|NCT01412957|183101184|SUPERIORITY_OR_OTHER||Normal score|-6.08|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.||||<0.0001
91604187|NCT01412957|183101185|SUPERIORITY_OR_OTHER||Normal score|-2.47||||0.0135|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.||||0.0135
91604188|NCT01412957|183101186|SUPERIORITY_OR_OTHER||Normal score|-5.98|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.||||<0.0001
91604189|NCT01412957|183101187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.89|||<|0.0001|TWO_SIDED|95.0|7.47|123.77|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||123.77|7.47|<0.0001
91650899|NCT01965652|183194500|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|0.83|1.72||The significance level was set at 0.05 (2-sided). The analysis of efficacy endpoints was not adjusted for multiplicity; hence, the p-values are purely nominal. A mixed-effects model repeated measures (MMRM) method was used for the comparisons.|Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||1.72|0.83|<0.0001
91523190|NCT01859793|182921968|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
91604190|NCT01412957|183101188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0|||<|0.0001|TWO_SIDED|95.0|5.89|101.62|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||101.62|5.89|<0.0001
91604191|NCT00954109|183101203|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91604192|NCT00954109|183101204|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91604193|NCT00288574|183101212|SUPERIORITY|||||||0.57|||||||Chi-squared|||The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.||||0.57
91604194|NCT00288574|183101213|SUPERIORITY|||||||0.75||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.||||0.75
91604195|NCT00288574|183101214|SUPERIORITY|||||||0.007||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups||||0.007
91604196|NCT00288574|183101215|SUPERIORITY|||||||0.79||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.||||0.79
91604197|NCT00288574|183101216|SUPERIORITY|||||||0.69||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.||||0.69
91604198|NCT00288574|183101217|SUPERIORITY|||||||0.78||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.||||0.78
91523191|NCT01064297|182922016|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.2||||||95.0|1.6|3.1|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.1|1.6|
91523192|NCT01064297|182922016|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|4.2||||||95.0|1.4|11.0|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||11.0|1.4|
91523193|NCT01064297|182922016|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.4||||||95.0|1.7|3.3|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.3|1.7|
91523194|NCT01064297|182922017|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|10.7||||||95.0|6.4|17.0||||||||17.0|6.4|
91523195|NCT01064297|182922017|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|9.3||||||95.0|5.5|15.2|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||15.2|5.5|
91523196|NCT01064297|182922018|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.5|5.0||||||||5.0|1.5|
91523197|NCT01064297|182922018|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.6|4.9|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||4.9|1.6|
91604199|NCT00288574|183101218|SUPERIORITY|||||||0.19||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.||||0.19
91523198|NCT00947661|182922023|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was \<1.5, and upper limit of 95% CI was \<1 at most (at least 7 of 12) time point.|||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
91523199|NCT00511875|182922034|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
91523200|NCT00511875|182922035|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Foveal Sensitivity||||.33
91523201|NCT00511875|182922035|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Mean field sensitivity||||.16
91604200|NCT00288574|183101219|SUPERIORITY|||||||0.46||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.||||0.46
91604201|NCT00288574|183101220|SUPERIORITY|||||||0.86||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.||||0.86
91523202|NCT00511875|182922036|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Foveal Sensitivity||||.02
91523203|NCT00511875|182922036|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||mean FDP sensitivity||||.3
91523204|NCT00511875|182922037|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||.98
91523205|NCT00511875|182922038|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||.46
91523206|NCT00511875|182922039|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||.81
91650900|NCT01965652|183194500|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.53|1.47|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||1.47|0.53|<0.0001
91650901|NCT01965652|183194500|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.52|1.5|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||1.50|0.52|<0.0001
91523207|NCT00511875|182922040|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
91650902|NCT01965652|183194500|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.259||0.0001|TWO_SIDED|95.0|0.49|1.51|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||1.51|0.49|0.0001
91709556|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
91523208|NCT00511875|182922041|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
91523209|NCT00511875|182922042|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||.62
91523210|NCT01349920|182922053|SUPERIORITY_OR_OTHER|||||||0.071|||||||Multiple Linear Regression|||Week 6||||0.071
91523211|NCT01349920|182922053|SUPERIORITY_OR_OTHER|||||||0.381|||||||Multiple Linear Regression|||Week 22||||0.381
91790806|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|10.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790807|NCT02880956|183460082|SUPERIORITY||LS Mean of Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.39||0.393|TWO_SIDED|95.0|-3.923|1.546||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.546|-3.923|0.393
91790808|NCT02880956|183460082|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|9.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790809|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.262||0.946|TWO_SIDED|95.0|-0.534|0.498||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.498|-0.534|0.946
91790810|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790811|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.259||0.242|TWO_SIDED|95.0|-0.813|0.206||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.206|-0.813|0.242
91790812|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790813|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.266||0.541|TWO_SIDED|95.0|-0.685|0.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.360|-0.685|0.541
91790814|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790815|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.724|TWO_SIDED|95.0|-0.481|0.691||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.691|-0.481|0.724
91790816|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790817|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.236|TWO_SIDED|95.0|-0.226|0.913||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.913|-0.226|0.236
91790818|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|2.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790819|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.714|TWO_SIDED|95.0|-0.477|0.695||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.695|-0.477|0.714
91790820|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790821|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.277||0.86|TWO_SIDED|95.0|-0.496|0.593||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.593|-0.496|0.860
91790822|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790823|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.274||0.476|TWO_SIDED|95.0|-0.733|0.343||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.343|-0.733|0.476
91790824|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523212|NCT01678131|182922088|SUPERIORITY_OR_OTHER_LEGACY||Posterior Percentage Probability|100.0||||||||||||||The posterior percentage probability of the true success rate of the FNA procedure for the 3 combined treatment groups (n=29) was determined by a Bayesian calculation, using a Jeffrey's prior distribution (i.e. Beta \[0.5,0.5\]) on the true success rate. Neither P-values, nor confidence intervals are estimated in this analysis. The primary hypothesis was met if the posterior percentage probability was \> 80% that the true success rate is at least 60%.||||
91523213|NCT03152084|182922100|OTHER|Within-group change|Least square mean|-5.21||||0.4462|TWO_SIDED|95.0|-19.542|9.12||Start of treatment vs baseline|Mixed Models Analysis|||||9.120|-19.542|0.4462
91523214|NCT03152084|182922101|OTHER|Within-group change|Least square mean|3.69||||0.7842|TWO_SIDED|95.0|-24.817|32.195||End of treatment vs baseline|Mixed Models Analysis|||||32.195|-24.817|0.7842
91523215|NCT03152084|182922101|OTHER|Within-group change|Least square mean|-16.72||||0.0581|TWO_SIDED|95.0|-34.109|0.664||Follow-up vs End of treatment|Regression, Linear|||||0.664|-34.109|0.0581
91523216|NCT03152084|182922102|OTHER|Within-group change|Least square mean|344.85|||<|0.0001|TWO_SIDED|95.0|272.785|416.905||Start of treatment vs baseline|Mixed Models Analysis|||||416.905|272.785|<0.0001
91523217|NCT03152084|182922103|OTHER|Within-group change|Least square mean|311.3|||<|0.0001|TWO_SIDED|95.0|224.528|398.064||End of treatment vs baseline|Mixed Models Analysis|||||398.064|224.528|<0.0001
91523218|NCT03152084|182922104|OTHER|Within-group change|Least square mean|-203.07|||<|0.0001|TWO_SIDED|95.0|-235.983|-170.162||Follow-up vs end of treatment|Regression, Linear|||||-170.162|-235.983|<0.0001
91523219|NCT03152084|182922105|OTHER|Within-group change|Least square mean|-5.2658||||0.0047|TWO_SIDED|95.0|-8.5459|-1.9856||Start of treatment vs baseline|Mixed Models Analysis|||||-1.9856|-8.5459|0.0047
91523220|NCT03152084|182922106|OTHER|Within-group change|Least square mean|-7.0987||||0.0003|TWO_SIDED|95.0|-10.0379|-4.1595||End of treatment vs baseline|Mixed Models Analysis|||||-4.1595|-10.0379|0.0003
91523221|NCT03152084|182922107|OTHER|Within-group change|Least square mean|0.7287||||0.5592|TWO_SIDED|95.0|-1.9894|3.4468||Follow-up vs end of treatment|Regression, Linear|||||3.4468|-1.9894|0.5592
91650903|NCT01965652|183194502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.25|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.25|-0.44|<0.0001
91523222|NCT03152084|182922108|OTHER|Within-group change|Least square mean|0.0315||||0.9288|TWO_SIDED|95.0|-0.7274|0.7904||Start of treatment vs baseline|Mixed Models Analysis|||||0.7904|-0.7274|0.9288
91523223|NCT03152084|182922109|OTHER|Within-group change|Least square mean|-0.4318||||0.1659|TWO_SIDED|95.0|-1.0761|0.2125||End of treatment vs baseline|Mixed Models Analysis|||||0.2125|-1.0761|0.1659
91523224|NCT03152084|182922110|OTHER|Within-group change|Least square mean|0.4755||||0.019|TWO_SIDED|95.0|0.0963|0.8548||Follow-up vs end of treatment|Regression, Linear|||||0.8548|0.0963|0.0190
91523225|NCT03152084|182922111|OTHER|Within-group change|Least square mean|-0.6713||||0.0157|TWO_SIDED|95.0|-1.1914|-0.1511||Start of treatment vs baseline|Mixed Models Analysis|||||-0.1511|-1.1914|0.0157
91523226|NCT03152084|182922112|OTHER|Within-group change|Least square mean|-0.0324||||0.87|TWO_SIDED|95.0|-0.4631|0.3984||End of treatment vs baseline|Mixed Models Analysis|||||0.3984|-0.4631|0.8700
91523227|NCT03152084|182922113|OTHER|Within-group change|Least square mean|0.1718||||0.2446|TWO_SIDED|95.0|-0.1358|0.4795||Follow-up vs end of treatment|Regression, Linear|||||0.4795|-0.1358|0.2446
91523228|NCT03152084|182922114|OTHER|Within-group change|Least square mean|-2.1||||0.0023|TWO_SIDED|95.0|-3.299|-0.902||Start of treatment vs baseline|Mixed Models Analysis|||||-0.902|-3.299|0.0023
91523229|NCT03152084|182922114|OTHER|Within-group change|Least square mean|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.929|-1.256||End of treatment vs baseline|Mixed Models Analysis|||||-1.256|-1.929|<0.0001
91523230|NCT03152084|182922114|OTHER|Within-group change|Least square mean|3.88||||0.0002|TWO_SIDED|95.0|2.215|5.553||Follow-up vs end of treatment|Regression, Linear|||||5.553|2.215|0.0002
91523231|NCT05361655|182922156|OTHER||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.65|0.87|||Cox proportional hazard model|||||0.87|0.65|<0.0001
91523232|NCT05361655|182922157|OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.62|0.76|||Cox proportional hazards model|||||0.76|0.62|<0.0001
91523233|NCT05361655|182922159|OTHER||||||<|0.0001|||||||score test|||||||<0.0001
91523234|NCT05361655|182922162|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.6|0.72|||Cox proportional hazard model|||||0.72|0.60|<0.0001
91523235|NCT05361655|182922163|OTHER||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.51|0.62|||Cox proportional hazard model|||||0.62|0.51|<0.0001
91650904|NCT01965652|183194502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.36|<0.0001
91523236|NCT05361655|182922164|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Cox proportional hazard model|||||0.86|0.69|<0.0001
91523237|NCT05361655|182922165|OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7|||Cox proportional hazards model|||||0.70|0.54|<0.0001
91523238|NCT03750006|182922167|SUPERIORITY|||||||0.0238||||||Not adjusted for multiple comparisons, P \< 0.05 is considered significant.|t-test, 2 sided|paired T-test||||||0.0238
91523239|NCT03750006|182922168|SUPERIORITY|||||||0.3029|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3029
91523240|NCT03750006|182922169|SUPERIORITY|||||||0.1713|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1713
91523241|NCT03750006|182922170|SUPERIORITY|||||||0.1261|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1261
91523242|NCT03750006|182922171|SUPERIORITY|||||||0.1367|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1367
91523243|NCT03750006|182922172|SUPERIORITY|||||||0.0111|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.0111
91523244|NCT03750006|182922173|SUPERIORITY|||||||0.0219|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0219
91523245|NCT03750006|182922174|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|Paired, P \< 0.05 considered significant.||||||0.3660
91523246|NCT03750006|182922177|SUPERIORITY|||||||0.1563|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1563
91523247|NCT03750006|182922178|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0110
91523248|NCT03750006|182922179|OTHER|||||||0.3282|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3282
91523249|NCT03750006|182922180|SUPERIORITY|||||||0.5244|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5244
91523250|NCT03750006|182922181|SUPERIORITY|||||||0.5718|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5718
91523251|NCT00939731|182922229|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.61|||||TWO_SIDED|90.0|84.84|101.09||||||Natural log transformed AUClast of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.09|84.84|
91523252|NCT00939731|182922232|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.43|||||TWO_SIDED|90.0|84.86|100.68||||||Natural log transformed AUC (0-∞) of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.68|84.86|
91650905|NCT01965652|183194502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.4|-0.18|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.18|-0.40|<0.0001
91604202|NCT00288574|183101221|SUPERIORITY|||||||0.25||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.||||0.25
91604203|NCT00288574|183101222|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.||Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.||||0.26
91604204|NCT02292771|183101254|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.3797|TWO_SIDED|95.0|-8.879|6.479|||Finite mixture model|||||6.479|-8.879|0.3797
91604205|NCT02292771|183101255|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.44|2.18|||Regression, Logistic|||||2.18|0.44|0.9520
91604206|NCT02292771|183101256|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.46|2.29|||Regression, Logistic|||||2.29|0.46|0.9520
91604207|NCT02292771|183101257|SUPERIORITY||Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.222||0.5672|TWO_SIDED|95.0|0.73|1.76|||ANCOVA|||||1.76|0.73|0.5672
91604208|NCT02292771|183101258|SUPERIORITY||Odds Ratio (OR)|1.9||||0.5066|TWO_SIDED|95.0|0.3|11.71|||Regression, Logistic|||||11.71|0.30|0.5066
91604209|NCT02292771|183101264|SUPERIORITY||Odds Ratio (OR)|0.8||||0.779|TWO_SIDED|95.0|0.12|4.84|||Regression, Logistic|||||4.84|0.12|0.7790
91650906|NCT01965652|183194502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.24|-0.47|<0.0001
91650907|NCT01965652|183194502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.35|-0.12|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.12|-0.35|<0.0001
91604210|NCT02292771|183101265|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6646|TWO_SIDED|95.0|0.51|2.9|||Regression, Logistic|||||2.90|0.51|0.6646
91650908|NCT01965652|183194503|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.054||0.0002|TWO_SIDED|95.0|-0.31|-0.1|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.10|-0.31|0.0002
91604211|NCT02292771|183101266|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1432|TWO_SIDED|95.0|0.75|7.24|||Regression, Logistic|||||7.24|0.75|0.1432
91604212|NCT02292771|183101267|SUPERIORITY||Odds Ratio (OR)|1.5||||0.525|TWO_SIDED|95.0|0.43|5.15|||Regression, Logistic|||||5.15|0.43|0.5250
91604213|NCT02292771|183101268|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4682|TWO_SIDED|95.0|0.13|2.58|||Regression, Logistic|||||2.58|0.13|0.4682
91604214|NCT04596891|183101296|OTHER|Repeated measures ANOVA|F ratio|20.62|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio.|No control group, open trial for feasibility/safety||||<0.001
91604215|NCT04596891|183101296|OTHER|Paired-samples t-test (baseline to post-treatment)|paired-samples t-test|5.2||||0.002|TWO_SIDED|95.0|-1.79|12.93|||t-test, 2 sided|||||12.93|-1.79|0.002
91604216|NCT04596891|183101301|OTHER|ANOVA|F ratio|8.46|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio. If it exceeds the critical F ratio, the null hypothesis (no effect of time) is rejected.|||||<0.001
91604217|NCT03532100|183101338|SUPERIORITY|||||||0.029|||||||Regression, Linear|||Hypothesis testing for the association between outcome and coupling ratio was carried out using conditional F-tests with degrees of freedom estimated using the Kenward-Roger method.||||0.029
91604218|NCT03532100|183101338|SUPERIORITY|||||||0.047||||||Pairwise hypothesis testing was carried out with adjustments for multiple comparisons using Tukey's method.|Regression, Linear|||6:1 versus 3:1||||0.047
91604219|NCT03532100|183101338|SUPERIORITY|||||||0.016||||||Pairwise hypothesis testing was carried out with adjustments for multiple comparisons using Tukey's method.|Regression, Linear|||6:1 versus 2:1||||0.016
91604220|NCT03532100|183101338|SUPERIORITY|||||||0.34|||||||Regression, Linear|||Hypothesis testing for the association between outcome and coupling ratio was carried out using conditional F-tests with degrees of freedom estimated using the Kenward-Roger method.||||0.340
91604221|NCT03532100|183101338|SUPERIORITY|||||||0.04|||||||Regression, Linear|||Hypothesis testing for the association between outcome and coupling ratio was carried out using conditional F-tests with degrees of freedom estimated using the Kenward-Roger method.||||0.040
91604222|NCT03532100|183101338|SUPERIORITY|||||||0.036||||||Pairwise hypothesis testing was carried out with adjustments for multiple comparisons using Tukey's method.|Regression, Linear|||6:1 versus 3:1||||0.036
91650909|NCT01965652|183194503|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0173|TWO_SIDED|95.0|-0.26|-0.03|||Mixed-effects model repeated meaures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.03|-0.26|0.0173
91650910|NCT01965652|183194503|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0035|TWO_SIDED|95.0|-0.3|-0.06|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.06|-0.30|0.0035
91604223|NCT03532100|183101338|SUPERIORITY|||||||0.028||||||Pairwise hypothesis testing was carried out with adjustments for multiple comparisons using Tukey's method.|Regression, Linear|||6:1 versus 2:1||||0.028
91604224|NCT03896581|183101340|SUPERIORITY||Odds Ratio (OR)|11.139|||<|0.001|TWO_SIDED|95.0|5.402|22.969|||Regression, Logistic|||||22.969|5.402|<0.001
91650911|NCT01965652|183194503|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.4|-0.16|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.16|-0.40|<0.0001
91523253|NCT00939731|182922233|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|98.91|||||TWO_SIDED|90.0|90.18|108.48||||||Natural log transformed Cmax of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CI for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.48|90.18|
91523254|NCT01392300|182922236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
91523255|NCT01392300|182922237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.1|0.5|||ANCOVA|||||0.5|0.1|0.003
91523256|NCT01392300|182922238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.001|TWO_SIDED|95.0|2.43|7.52|||Regression, Logistic|||||7.52|2.43|<0.001
91604225|NCT03896581|183101341|SUPERIORITY||Least square (LS) mean difference|-0.326|||<|0.001|TWO_SIDED|95.0|-0.42|-0.233|||ANCOVA|||||-0.233|-0.420|<0.001
91650912|NCT01965652|183194503|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.064||0.0336|TWO_SIDED|95.0|-0.26|-0.01|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.01|-0.26|0.0336
91604226|NCT03896581|183101343|SUPERIORITY||Odds Ratio (OR)|30.237|||<|0.001|TWO_SIDED|95.0|12.365|73.94|||Regression, Logistic|||||73.940|12.365|<0.001
91604227|NCT03896581|183101344|SUPERIORITY||LS mean difference|6.037|||<|0.001|TWO_SIDED|95.0|4.386|7.688|||ANCOVA|||||7.688|4.386|<0.001
91790825|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.276||0.586|TWO_SIDED|95.0|-0.393|0.694||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.694|-0.393|0.586
91523257|NCT01392300|182922239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.56|4.63|||Regression, Logistic|||||4.63|1.56|<0.001
91604228|NCT03896581|183101345|SUPERIORITY||Odds Ratio (OR)|13.089|||<|0.001|TWO_SIDED|95.0|6.119|27.999|||Regression, Logistic|||||27.999|6.119|<0.001
91604229|NCT02660580|183101367|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval \[-15%, 15%\]).|Least Square (LS) Mean difference|0.88|||||TWO_SIDED|95.0|-1.21|2.98||||||||2.98|-1.21|
91604230|NCT02660580|183101383|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).|Percentage difference|-1.9|||||TWO_SIDED|95.0|-7.82|4.07||||||||4.07|-7.82|
91604231|NCT00951821|183101408|SUPERIORITY_OR_OTHER||Slope|-3.3||||0.46|TWO_SIDED|95.0|-12.1|5.5||Effect sizes were also calculated due to small sample size|Mixed Models Analysis||The reported statistic (-3.3) is the difference in the change from baseline to follow-up between the two treatment arms, estimated in a mixed effect regression model.|||5.5|-12.1|.46
91604232|NCT00951821|183101409|SUPERIORITY_OR_OTHER||Slope|0.4||||0.75|TWO_SIDED|95.0|-2.36|3.06|||Mixed Models Analysis||The statistic provided (0.4) is the difference in the change in BDI score from baseline to follow-up by treatment group.|||3.06|-2.36|.75
91604233|NCT01903876|183101418|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.044|||||||ANCOVA|||||||.044
91604234|NCT01903876|183101419|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.042|||||||ANCOVA|||||||.042
91604235|NCT02300129|183101442|SUPERIORITY_OR_OTHER|||||||0.742|TWO_SIDED|||||P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5% (two-sided).|ANOVA|Analysis of variance including sequence, subject (sequence), period and treatment as factors in the model||||||0.7420
91523258|NCT01392300|182922240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.004|TWO_SIDED|95.0|1.33|4.61|||Regression, Logistic|||||4.61|1.33|0.004
91604236|NCT02747927|183101458|OTHER||VE|80.2|||<|0.001|TWO_SIDED|95.0|73.3|85.3||Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.|Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.||85.3|73.3|<0.001
91604237|NCT02747927|183101459|OTHER||VE|90.4|||<|0.001|TWO_SIDED|95.0|82.6|94.7||Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 0%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.|Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||94.7|82.6|<0.001
91790826|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523259|NCT01392300|182922241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.57|||Regression, Logistic|||||5.57|1.76|<0.001
91523260|NCT01392300|182922242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.021|TWO_SIDED|95.0|1.1|3.34|||Regression, Logistic|||||3.34|1.10|0.021
91523261|NCT01392300|182922243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.32|5.05|||Regression, Logistic|||||5.05|1.32|0.006
91523262|NCT01392300|182922244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.06|6.72|||Regression, Logistic|||||6.72|2.06|<0.001
91523263|NCT01392300|182922245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.002|TWO_SIDED|95.0|1.4|4.46|||Regression, Logistic|||||4.46|1.40|0.002
91604238|NCT02747927|183101460|OTHER||VE|69.8|||||TWO_SIDED|95.0|54.8|79.9|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||79.9|54.8|
91604239|NCT02747927|183101460|OTHER||VE|95.1|||||TWO_SIDED|95.0|89.9|97.6|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||97.6|89.9|
91604240|NCT02747927|183101460|OTHER||VE|48.8|||||TWO_SIDED|95.0|27.1|64.1|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||64.1|27.1|
91604241|NCT02747927|183101460|OTHER||VE|50.9|||||TWO_SIDED|95.0|-69.7|85.8|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||85.8|-69.7|
91604242|NCT02747927|183101461|OTHER||VE|66.2|||||TWO_SIDED|95.0|49.1|77.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||77.5|49.1|
91604243|NCT02747927|183101462|OTHER||VE|76.1|||||TWO_SIDED|95.0|68.5|81.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||81.9|68.5|
91604244|NCT02747927|183101463|OTHER||VE|2.2|||||TWO_SIDED|95.0|-978.5|91.1|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||91.1|-978.5|
91604245|NCT02747927|183101472|OTHER||VE|47.4|||||TWO_SIDED|95.0|37.1|56.0|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region|||56.0|37.1|
91650913|NCT01965652|183194504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.37|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.37|<0.0001
91604246|NCT02747927|183101473|OTHER||VE|55.7|||||TWO_SIDED|95.0|34.5|70.0|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||70.0|34.5|
91604247|NCT02747927|183101474|OTHER||VE|73.5|||||TWO_SIDED|95.0|56.3|83.9|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||83.9|56.3|
91650914|NCT01965652|183194504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.063||0.0114|TWO_SIDED|95.0|-0.28|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.04|-0.28|0.0114
91604248|NCT02747927|183101475|OTHER||VE|93.7|||||TWO_SIDED|95.0|72.4|98.6|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||98.6|72.4|
91650915|NCT01965652|183194504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.11|-0.36|0.0003
91650916|NCT01965652|183194504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.13|-0.38|<0.0001
91604249|NCT02747927|183101476|OTHER||VE|79.4|||||TWO_SIDED|95.0|70.1|85.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||85.9|70.1|
91604250|NCT02747927|183101477|OTHER||VE|76.8|||||TWO_SIDED|95.0|57.1|87.4|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||87.4|57.1|
91604251|NCT02747927|183101477|OTHER||VE|85.7|||||TWO_SIDED|95.0|69.9|93.2|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||93.2|69.9|
91790827|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.324||0.412|TWO_SIDED|95.0|-0.371|0.903||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.903|-0.371|0.412
91790828|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790829|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.319||0.45|TWO_SIDED|95.0|-0.386|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.868|-0.386|0.450
91790830|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790831|NCT02880956|183460083|SUPERIORITY||LS Mean of Difference|0.17|STANDARD_ERROR_OF_MEAN|0.33||0.612|TWO_SIDED|95.0|-0.481|0.816||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.816|-0.481|0.612
91790832|NCT02880956|183460083|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523264|NCT01392300|182922246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.102|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||||3.22|0.90|0.102
91523265|NCT01392300|182922247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.67|5.23|||Regression, Logistic|||||5.23|1.67|<0.001
91523266|NCT01392300|182922248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.002|TWO_SIDED|95.0|1.37|4.41|||Regression, Logistic|||||4.41|1.37|0.002
91523267|NCT01392300|182922249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.069|TWO_SIDED|95.0|0.95|3.69|||Regression, Logistic|||||3.69|0.95|0.069
91523268|NCT01392300|182922250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.034|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.034
91523269|NCT01392300|182922251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.169|TWO_SIDED|95.0|0.82|3.16|||Regression, Logistic|||||3.16|0.82|0.169
91523270|NCT01392300|182922252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.49|2.18|||Regression, Logistic|||||2.18|0.49|0.920
91523271|NCT01392300|182922253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.83|6.91|||Regression, Logistic|||||6.91|1.83|<0.001
91523272|NCT01392300|182922254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.007|TWO_SIDED|95.0|1.28|4.56|||Regression, Logistic|||||4.56|1.28|0.007
91523273|NCT01392300|182922255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26||||0.018|TWO_SIDED|95.0|1.15|4.41|||Regression, Logistic|||||4.41|1.15|0.018
91523274|NCT01392300|182922256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
91523275|NCT01392300|182922257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.011|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.011
91523276|NCT01392300|182922258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.032
91523277|NCT01392300|182922259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|<0.001
91523278|NCT01392300|182922260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|<0.001
91604252|NCT02747927|183101477|OTHER||VE|62.0|||||TWO_SIDED|95.0|-69.7|91.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||91.5|-69.7|
91604253|NCT02747927|183101477|OTHER||VE|77.2|||||TWO_SIDED|95.0|54.8|88.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||88.5|54.8|
91604254|NCT02747927|183101478|OTHER||VE|79.2|||||TWO_SIDED|95.0|57.8|89.7|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Any Dengue Serotype||89.7|57.8|
91604255|NCT02747927|183101478|OTHER||VE|86.0|||||TWO_SIDED|95.0|57.6|95.4|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||95.4|57.6|
91604256|NCT02747927|183101478|OTHER||VE|89.9|||||TWO_SIDED|95.0|13.5|98.8|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||98.8|13.5|
91604257|NCT02747927|183101478|OTHER||VE|42.7|||||TWO_SIDED|95.0|-307.5|92.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||92.0|-307.5|
91523279|NCT01392300|182922261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.029
91523280|NCT01392300|182922262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
91523281|NCT01392300|182922263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.019|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.019
91523282|NCT01392300|182922264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.137|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.137
91523283|NCT01392300|182922265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.013|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.013
91523284|NCT01392300|182922266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.131|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.131
91523285|NCT01392300|182922267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.714|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.714
91523286|NCT01392300|182922268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
91523287|NCT01392300|182922269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.008
91523288|NCT01392300|182922270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.062|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.062
91523289|NCT01392300|182922271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.006
91523290|NCT01392300|182922272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.076
91523291|NCT01392300|182922273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.416|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.416
91523292|NCT01392300|182922274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|<0.001
91523293|NCT01392300|182922275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.175|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.175
91787651|NCT02874144|183454849|SUPERIORITY|This was a superiority trial. We used repeated-measures linear regression using the mixed procedure to calculate means for each outcome by visits and treatment status. We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time between scores within the treatment group (AZD1981 plus INCS) to scores within the placebo group (INCS treatment only).|Mean Difference (Final Values)|-20.0|||<|0.05|TWO_SIDED|||||No, the p-value was not adjusted for multiple comparisons.|repeated-measures linear regression|We used repeated-measures linear regression using the MIXED procedure to calculate means (SEMS) for each outcome by visits and treatment status.|Our study did not include at relative risk.|The trial design is a continuous outcome superiority trial with primary efficacy outcome measures of change in Total Polyp Score (TPS) comparing AZD to placebo arm from V1 to V5. Total polyp score is a standardized method for assessing nasal polyp size by endoscopy, based on a scale of 1-4 per side. Inclusion criterion for this study is a TPS of ≥4 with a maximum of 8 and a standard deviation ± 2. A clinically meaningful effect is considered to be a decrease in total polyp score of 1.5.||||<0.05
91787652|NCT02975557|183454870|OTHER|||||||1|||||||Fisher Exact|The type I error was adjusted by using the alpha spending function approach with O'Brien-Fleming type boundaries.||We evaluated if the categorical type of tolerability measure is different between control (Artificial Tears) and intervention (Brimonidine, including both 0.15% high and 0.075% low doses groups).||||1
91604258|NCT02747927|183101478|OTHER||VE|61.0|||||TWO_SIDED|95.0|-45.1|89.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||89.5|-45.1|
91787653|NCT04525885|183454871|SUPERIORITY|Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|Estimated Relative Reduction (%)|8.7||||0.713|TWO_SIDED|95.0|-30.51|70.03|||ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||70.03|-30.51|0.713
91787654|NCT04525885|183454874|SUPERIORITY||Estimated Relative Reduction (%)|11.58||||0.628|TWO_SIDED|95.0|-28.68|74.57||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||74.57|-28.68|0.628
91604259|NCT02747927|183101479|OTHER||VE|79.6|||||TWO_SIDED|95.0|68.3|86.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Any Dengue Serotype||86.9|68.3|
91604260|NCT02747927|183101479|OTHER||VE|69.9|||||TWO_SIDED|95.0|36.4|85.8|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||85.8|36.4|
91604261|NCT02747927|183101479|OTHER||VE|84.9|||||TWO_SIDED|95.0|66.6|93.2|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||93.2|66.6|
91604262|NCT02747927|183101479|OTHER||VE|75.6|||||TWO_SIDED|95.0|-168.8|97.8|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||97.8|-168.8|
91650917|NCT01965652|183194504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0119|TWO_SIDED|95.0|-0.29|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.04|-0.29|0.0119
91604263|NCT02747927|183101479|OTHER||VE|81.0|||||TWO_SIDED|95.0|57.2|91.6|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||91.6|57.2|
91604264|NCT02747927|183101480|OTHER||VE|93.8|||||TWO_SIDED|95.0|79.3|98.1|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||98.1|79.3|
91650918|NCT01965652|183194505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.64|-0.39|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.39|-0.64|<0.0001
91787655|NCT04525885|183454875|SUPERIORITY||Odds Ratio (OR)|0.96||||0.917|TWO_SIDED|95.0|0.43|2.13||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||2.13|0.43|0.917
91604265|NCT02747927|183101481|OTHER||VE|100.0|||||TWO_SIDED|95.0|-849.4|100.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||100.0|-849.4|
91604266|NCT02747927|183101482|OTHER||VE|67.2|||||TWO_SIDED|95.0|52.1|77.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||77.5|52.1|
91523294|NCT01392300|182922276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.14|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.140
91604267|NCT02747927|183101483|OTHER||VE|56.5|||||TWO_SIDED|95.0|16.2|77.4|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||77.4|16.2|
91787656|NCT04525885|183454876|SUPERIORITY||Odds Ratio (OR)|0.85||||0.687|TWO_SIDED|95.0|0.38|1.88||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour by visit as covariates.|Regression, Logistic|||||1.88|0.38|0.687
91787657|NCT04525885|183454877|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.49|2.49||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.49|0.49|
91787658|NCT04525885|183454878|OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.8|4.64||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates||4.64|0.80|
91787659|NCT04525885|183454879|OTHER|Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.45|2.72||||||||2.72|0.45|
91787660|NCT03158285|183454881|SUPERIORITY||Difference in percentage|31.2|||<|0.001|TWO_SIDED|95.0|22.9|39.5|||Cochran-Mantel-Haenszel|||||39.5|22.9|< 0.001
91650919|NCT01965652|183194505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.51|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.51|<0.0001
91650920|NCT01965652|183194505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.54|-0.27|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.27|-0.54|<0.0001
91650921|NCT01965652|183194505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.34|-0.62|<0.0001
91650922|NCT01965652|183194505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.52|-0.23|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.23|-0.52|<0.0001
91787661|NCT03158285|183454881|SUPERIORITY||Difference in percentage|30.8|||<|0.001|TWO_SIDED|95.0|22.4|39.1|||Cochran-Mantel-Haenszel|||||39.1|22.4|< 0.001
91523295|NCT01392300|182922277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.007
91523296|NCT01392300|182922278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.018
91650923|NCT01965652|183194506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.49|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.30|-0.49|<0.0001
91787662|NCT03158285|183454882|SUPERIORITY||Least Square (LS) Mean difference|-0.2372|||<|0.001|TWO_SIDED|95.0|-0.321|-0.1534|||ANCOVA|||||-0.1534|-0.3210|< 0.001
91787663|NCT03158285|183454882|SUPERIORITY||LS Mean difference|-0.2704|||<|0.001|TWO_SIDED|95.0|-0.3544|-0.1864|||ANCOVA|||||-0.1864|-0.3544|< 0.001
91787664|NCT03158285|183454883|SUPERIORITY||Difference in percentage|17.2|||<|0.001||95.0|10.0|24.4||Nominal|Cochran-Mantel-Haenszel|||||24.4|10.0|< 0.001
91787665|NCT03158285|183454883|SUPERIORITY||Difference in percentage|18.8|||<|0.001|TWO_SIDED|95.0|11.5|26.1||Nominal|Cochran-Mantel-Haenszel|||||26.1|11.5|< 0.001
91787666|NCT03158285|183454884|SUPERIORITY||Difference in percentage|50.9|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||Cochran-Mantel-Haenszel|||||59.7|42.2|<0.001
91787667|NCT03158285|183454884|SUPERIORITY||Difference in percentage|49.8|||<|0.001|TWO_SIDED|95.0|41.2|58.4|||Cochran-Mantel-Haenszel|||||58.4|41.2|< 0.001
91787668|NCT03158285|183454885|SUPERIORITY||Difference in percentage|21.5|||<|0.001|TWO_SIDED|95.0|13.1|30.0||Nominal|Cochran-Mantel-Haenszel|||||30.0|13.1|< 0.001
91787669|NCT03158285|183454885|SUPERIORITY||Difference in percentage|22.2|||<|0.001|TWO_SIDED|95.0|13.7|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|13.7|< 0.001
91787670|NCT03158285|183454886|SUPERIORITY||LS Mean difference|-0.43||||0.072|TWO_SIDED|95.0|-0.9|0.03|||ANCOVA|||||0.03|-0.90|0.072
91787671|NCT03158285|183454886|SUPERIORITY||LS Mean difference|-0.66||||0.011|TWO_SIDED|95.0|-1.13|-0.19|||ANCOVA|||||-0.19|-1.13|0.011
91787672|NCT03158285|183454887|SUPERIORITY||Difference in response rates|20.1||||0.03|TWO_SIDED|95.0|11.8|28.5|||Cochran-Mantel-Haenszel|||||28.5|11.8|0.030
91787673|NCT03158285|183454887|SUPERIORITY||Difference in response rates|14.6||||0.03|TWO_SIDED|95.0|6.4|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.4|0.030
91787674|NCT03158285|183454888|SUPERIORITY||Difference in response rates|18.0||||0.03|TWO_SIDED|95.0|7.4|28.6|||Cochran-Mantel-Haenszel|||||28.6|7.4|0.030
91787675|NCT03158285|183454888|SUPERIORITY||Difference in response rates|21.3||||0.011|TWO_SIDED|95.0|10.5|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.5|0.011
91787676|NCT03158285|183454889|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.77|-0.23||Nominal|ANCOVA|||||-0.23|-0.77|< 0.001
91787677|NCT03158285|183454889|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.31||Nominal|ANCOVA|||||-0.31|-0.83|< 0.001
91787678|NCT03158285|183454890|SUPERIORITY||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.99|-0.79||Nominal|ANCOVA|||||-0.79|-2.99|< 0.001
91787679|NCT03158285|183454890|SUPERIORITY||LS Mean Difference|-1.77||||0.002|TWO_SIDED|95.0|-2.87|-0.66||Nominal|ANCOVA|||||-0.66|-2.87|0.002
91787680|NCT03158285|183454891|SUPERIORITY||LS Mean difference|3.97||||0.011|TWO_SIDED|95.0|2.75|5.2|||ANCOVA|||||5.20|2.75|0.011
91787681|NCT03158285|183454891|SUPERIORITY||LS Mean difference|3.62||||0.011|TWO_SIDED|95.0|2.39|4.85|||ANCOVA|||||4.85|2.39|0.011
91787682|NCT03158285|183454892|SUPERIORITY||LS Mean difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.43||Nominal|ANCOVA|||||-0.43|-0.80|< 0.001
91787683|NCT03158285|183454892|SUPERIORITY||LS Mean difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.83|-0.47||Nominal|ANCOVA|||||-0.47|-0.83|< 0.001
91787684|NCT03158285|183454893|SUPERIORITY||LS Mean difference|2.02||||0.072|TWO_SIDED|95.0|0.56|3.49|||ANCOVA|||||3.49|0.56|0.072
91787685|NCT03158285|183454893|SUPERIORITY||LS Mean difference|2.07||||0.072|TWO_SIDED|95.0|0.6|3.54|||ANCOVA|||||3.54|0.60|0.072
91787686|NCT03158285|183454894|SUPERIORITY||Difference in percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.6|25.9||Nominal|Cochran-Mantel-Haenszel|||||25.9|12.6|< 0.001
91787687|NCT03158285|183454894|SUPERIORITY||Difference in percentage|11.5|||<|0.001|TWO_SIDED|95.0|5.2|17.7||Nominal|Cochran-Mantel-Haenszel|||||17.7|5.2|< 0.001
91787688|NCT03158285|183454895|SUPERIORITY||Difference in percentage|14.5|||<|0.001|TWO_SIDED|95.0|9.1|19.9||Nominal|Cochran-Mantel-Haenszel|||||19.9|9.1|< 0.001
91787689|NCT03158285|183454895|SUPERIORITY||Difference in percentage|9.0|||<|0.001|TWO_SIDED|95.0|4.1|13.8||Nominal|Cochran-Mantel-Haenszel|||||13.8|4.1|< 0.001
91790833|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.405||0.52|TWO_SIDED|95.0|-1.058|0.535||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.535|-1.058|0.520
91604268|NCT02747927|183101483|OTHER||VE|86.6|||||TWO_SIDED|95.0|63.8|95.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||95.0|63.8|
91604269|NCT02747927|183101483|OTHER||VE|51.5|||||TWO_SIDED|95.0|9.9|73.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||73.9|9.9|
91604270|NCT02747927|183101483|OTHER||VE|85.5|||||TWO_SIDED|95.0|47.4|96.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||96.0|47.4|
91650924|NCT01965652|183194506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.46|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.46|<0.0001
91604271|NCT02747927|183101484|OTHER||VE|70.3|||||TWO_SIDED|95.0|39.1|85.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Any Dengue Serotype||85.5|39.1|
91604272|NCT02747927|183101484|OTHER||VE|57.3|||||TWO_SIDED|95.0|-27.2|85.7|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||85.7|-27.2|
91650925|NCT01965652|183194506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.22|-0.43|<0.0001
91787690|NCT00750152|183455097|SUPERIORITY_OR_OTHER||one-sided p-value from CMH test|0.001||||0.025|ONE_SIDED|95.0|||||Cochran-Mantel-Haenszel|The CMH test after stratification by site compared the proportion of complete cure in NAFT-500 to that of placebo to evaluate its superiority.||"In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~* H0: p1 \<= p0~* Ha: p1 \> p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively."||||0.025
91787691|NCT01809639|183455107|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||.42
91787692|NCT00978757|183455108|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91787693|NCT02140593|183455118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91787694|NCT02140593|183455119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91787695|NCT02043808|183455191|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.92|0.52|
91787696|NCT02043808|183455192|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.98|0.71|
91787697|NCT02043808|183455193|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.79|||||TWO_SIDED|95.0|0.59|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.59|
91787698|NCT02043808|183455194|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.31|||||TWO_SIDED|95.0|0.13|0.7|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.70|0.13|
91787699|NCT02043808|183455195|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.48|||||TWO_SIDED|95.0|0.3|0.77|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.77|0.30|
91787700|NCT02043808|183455196|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.76|
91604273|NCT02747927|183101484|OTHER||VE|90.0|||||TWO_SIDED|95.0|14.0|98.8|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||98.8|14.0|
91604274|NCT02747927|183101484|OTHER||VE|36.1|||||TWO_SIDED|95.0|-138.1|82.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||82.9|-138.1|
91604275|NCT02747927|183101484|OTHER||VE|100.0|||||TWO_SIDED|95.0|43.1|100.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||100.0|43.1|
91604276|NCT02747927|183101485|OTHER||VE|65.7|||||TWO_SIDED|95.0|46.4|78.1|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Any Dengue Serotype||78.1|46.4|
91604277|NCT02747927|183101485|OTHER||VE|56.2|||||TWO_SIDED|95.0|0.8|80.7|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||80.7|0.8|
91787701|NCT02043808|183455197|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.07|||||TWO_SIDED|95.0|0.89|1.3|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.30|0.89|
91787702|NCT02043808|183455198|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.72|||||TWO_SIDED|95.0|0.5|1.03|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.03|0.50|
91787703|NCT02043808|183455199|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.24|||||TWO_SIDED|95.0|0.99|1.54|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.54|0.99|
91787704|NCT02043808|183455200|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.35|||||TWO_SIDED|95.0|0.17|0.72|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.72|0.17|
91787705|NCT02043808|183455201|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.37|||||TWO_SIDED|95.0|0.22|0.64|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.64|0.22|
91787706|NCT02043808|183455202|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.55|1.26|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.26|0.55|
91787707|NCT02043808|183455203|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.66|||||TWO_SIDED|95.0|0.45|0.95|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.95|0.45|
91787708|NCT02043808|183455204|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.31|0.31|
91787709|NCT02043808|183455205|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.44|||||TWO_SIDED|95.0|0.16|1.21|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.21|0.16|
91787710|NCT02043808|183455206|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.97|||||TWO_SIDED|95.0|0.34|2.81|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||2.81|0.34|
91787711|NCT02043808|183455207|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.69|0.52|
91787712|NCT05601544|183455235|SUPERIORITY||Least-squares Mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.19|0.25||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.25|0.19|<.0001
91787713|NCT05601544|183455235|SUPERIORITY||Least-squares Mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.14|0.18||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.18|0.14|<.0001
91787714|NCT05601544|183455238|SUPERIORITY||Median Ratio|0.83||||0.0465|TWO_SIDED|98.33|0.64|1.09||1-sided p-value was calculated using one-sided type 1 error of 0.0083.|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Median Ratio was calculated as test over control|It was calculated that 16 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 92% power to detect a statistical superiority with respect to motion detection.||1.09|0.64|0.0465
91787715|NCT05601544|183455239|SUPERIORITY||Least-square Mean Difference|0.14|||<|0.0001|TWO_SIDED|98.33|0.112|0.17||1-sided p-value was calculated using one-sided type 1 error of 0.0083|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|It was calculated that 29 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 91% power to detect a statistical superiority with respect to motion detection.||0.170|0.112|<.0001
91790834|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790835|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.401||0.303|TWO_SIDED|95.0|-1.201|0.374||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.374|-1.201|0.303
91790836|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91604278|NCT02747927|183101485|OTHER||VE|85.1|||||TWO_SIDED|95.0|54.4|95.2|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||95.2|54.4|
91790837|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.412||0.23|TWO_SIDED|95.0|-1.307|0.315||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.315|-1.307|0.230
91604279|NCT02747927|183101485|OTHER||VE|54.7|||||TWO_SIDED|95.0|8.3|77.6|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||77.6|8.3|
91604280|NCT02747927|183101485|OTHER||VE|75.5|||||TWO_SIDED|95.0|2.2|93.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||93.9|2.2|
91523297|NCT01392300|182922279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.105|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.105
91523298|NCT01392300|182922280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.016
91523299|NCT01392300|182922281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.014|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.014
91523300|NCT01392300|182922282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.22|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.220
91790838|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91604281|NCT02747927|183101486|OTHER||VE|84.9|||||TWO_SIDED|95.0|53.7|95.1|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||95.1|53.7|
91604282|NCT02747927|183101488|OTHER||VE|74.3|||||TWO_SIDED|95.0|66.6|80.3|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||80.3|66.6|
91790839|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.5222||0.2|TWO_SIDED|95.0|-1.698|0.356||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.356|-1.698|0.200
91790840|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790841|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.508||0.873|TWO_SIDED|95.0|-1.08|0.917||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.917|-1.080|0.873
91790842|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790843|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.524||0.388|TWO_SIDED|95.0|-1.482|0.576||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.576|-1.482|0.388
91790844|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790845|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.587||0.734|TWO_SIDED|95.0|-1.355|0.955||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.955|-1.355|0.734
91790846|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790847|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.579||0.417|TWO_SIDED|95.0|-1.608|0.668||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.668|-1.608|0.417
91790848|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|4.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790849|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.589||0.252|TWO_SIDED|95.0|-1.836|0.482||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.482|-1.836|0.252
91790850|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790851|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.669||0.827|TWO_SIDED|95.0|-1.17|1.462||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.462|-1.170|0.827
91790852|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|4.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523301|NCT01392300|182922283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.429|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.429
91523302|NCT01392300|182922284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.884|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.884
91604283|NCT02747927|183101489|OTHER||VE|69.0|||||TWO_SIDED|95.0|51.7|80.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||80.0|51.7|
91604284|NCT02747927|183101489|OTHER||VE|85.9|||||TWO_SIDED|95.0|74.5|92.2|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||92.2|74.5|
91604285|NCT02747927|183101489|OTHER||VE|54.1|||||TWO_SIDED|95.0|19.1|73.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||73.9|19.1|
91523303|NCT01392300|182922285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.844|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.844
91523304|NCT01147822|182922296|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0184|||||TWO_SIDED|95.0|0.7658|1.3542|||||The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.|||1.3542|0.7658|
91523305|NCT01147822|182922297|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.604|TWO_SIDED|95.0|0.808|1.441|||Log Rank||Hazard ratios were estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with this treatment compared with Sunitinib.|||1.441|0.808|0.604
91523306|NCT03010462|182922303|SUPERIORITY|||||||0.62|||||||Chi-squared, Corrected|||||||0.62
91604286|NCT02747927|183101489|OTHER||VE|79.4|||||TWO_SIDED|95.0|62.4|88.7|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||88.7|62.4|
91604287|NCT02747927|183101490|OTHER||VE|75.3|||||TWO_SIDED|95.0|59.3|85.0|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Any Dengue Serotype||85.0|59.3|
91604288|NCT02747927|183101490|OTHER||VE|76.5|||||TWO_SIDED|95.0|50.0|88.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||88.9|50.0|
91604289|NCT02747927|183101490|OTHER||VE|89.9|||||TWO_SIDED|95.0|53.7|97.8|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||97.8|53.7|
91604290|NCT02747927|183101490|OTHER||VE|37.9|||||TWO_SIDED|95.0|-84.9|79.2|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||79.2|-84.9|
91604291|NCT02747927|183101490|OTHER||VE|78.4|||||TWO_SIDED|95.0|29.7|93.3|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-4||93.3|29.7|
91604292|NCT02747927|183101491|OTHER||VE|73.9|||||TWO_SIDED|95.0|64.4|80.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|Any Dengue Serotype||80.9|64.4|
91604293|NCT02747927|183101491|OTHER||VE|64.1|||||TWO_SIDED|95.0|37.8|79.3|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-1||79.3|37.8|
91604294|NCT02747927|183101491|OTHER||VE|84.9|||||TWO_SIDED|95.0|71.1|92.1|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-2||92.1|71.1|
91604295|NCT02747927|183101491|OTHER||VE|58.1|||||TWO_SIDED|95.0|18.5|78.5|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|DENV-3||78.5|18.5|
91790853|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|0.33|STANDARD_ERROR_OF_MEAN|0.657||0.615|TWO_SIDED|95.0|-0.962|1.624||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.624|-0.962|0.615
91604296|NCT02747927|183101491|OTHER||VE|79.7|||||TWO_SIDED|95.0|59.1|89.9|||Cox Proportional Hazard Model||VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||89.9|59.1|
91604297|NCT02747927|183101492|OTHER||VE|90.6|||||TWO_SIDED|95.0|78.8|95.8|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||95.8|78.8|
91604298|NCT02747927|183101493|OTHER||VE|100.0|||||TWO_SIDED|95.0|-849.4|100.0|||Cox Proportional Hazard Model||VE and two-sided 95% CIs are estimated from a Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.|||100.0|-849.4|
91604299|NCT00450580|183101518|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -12%.|Risk Difference (RD)|-0.9||||||95.0|-11.4|9.5||||||||9.5|-11.4|
91604300|NCT00988247|183101554|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.97|||<|0.001|TWO_SIDED|95.0|-1.5|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.5|<0.001
91523307|NCT03010462|182922304|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91523308|NCT03010462|182922305|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91523309|NCT03010462|182922306|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
91523310|NCT03010462|182922307|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
91604301|NCT00988247|183101555|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.96|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.4|<0.001
91604302|NCT00988247|183101556|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.09|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
91604303|NCT00988247|183101557|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
91790854|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.61|||TWO_SIDED|||||||||Week 96||||
91523311|NCT01966003|182922308|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).|Risk Ratio (RR)|0.93|||||TWO_SIDED|90.0|0.8|1.09||||||The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).||1.09|0.80|
91523312|NCT01966003|182922308|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9|||||TWO_SIDED|90.0|-9.26|3.45||||||Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.||3.45|-9.26|
91523313|NCT01966003|182922310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|90.0|0.83|1.29||||||The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.29|0.83|
91790855|NCT02880956|183460084|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.678||0.637|TWO_SIDED|95.0|-1.653|1.014||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.014|-1.653|0.637
91790856|NCT02880956|183460084|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|4.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790857|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.367||0.261|TWO_SIDED|95.0|-1.135|0.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.308|-1.135|0.261
91790858|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790859|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|0.29|STANDARD_ERROR_OF_MEAN|0.361||0.423|TWO_SIDED|95.0|-0.42|1.001||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.001|-0.420|0.423
91790860|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790861|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.371||0.322|TWO_SIDED|95.0|-1.097|0.361||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.361|-1.097|0.322
91790862|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|2.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790863|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.397||0.498|TWO_SIDED|95.0|-0.511|1.049||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.049|-0.511|0.498
91790864|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790865|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|0.75|STANDARD_ERROR_OF_MEAN|0.386||0.052|TWO_SIDED|95.0|-0.006|1.51||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.510|-0.006|0.052
91790866|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790867|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.398||0.597|TWO_SIDED|95.0|-0.993|0.572||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.572|-0.993|0.597
91790868|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790869|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.376||0.896|TWO_SIDED|95.0|-0.689|0.788||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.788|-0.689|0.896
91790870|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.4|||TWO_SIDED|||||||||Week 72||||
91790871|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|0.53|STANDARD_ERROR_OF_MEAN|0.369||0.149|TWO_SIDED|95.0|-0.192|1.258||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.258|-0.192|0.149
91790872|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523314|NCT01966003|182922313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.75|1.61||||||Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.61|0.75|
91790873|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.376||0.522|TWO_SIDED|95.0|-0.98|0.499||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.499|-0.980|0.522
91523315|NCT03299686|182922368|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_DEVIATION|0.043||0.7374|TWO_SIDED|80.0|-0.029|0.082||Probability CJM112 better than placebo|Bayesian linear repeated measures model||||Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.|0.082|-0.029|0.7374
91523316|NCT03299686|182922369|SUPERIORITY||Mean Difference (Net)|0.913|STANDARD_ERROR_OF_MEAN|1.434||0.263|TWO_SIDED|80.0|-0.939|2.766||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||2.766|-0.939|0.263
91523317|NCT03299686|182922370|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.061|TWO_SIDED|80.0|-0.41|-0.04||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.04|-0.41|0.061
91523318|NCT03299686|182922371|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|80.0|-0.4|-0.06||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.06|-0.40|0.040
91523319|NCT01060553|182922377|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||for mcs||||.15
91523320|NCT01060553|182922377|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||for pcs||||.28
91523321|NCT01060553|182922378|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||for sleep duration||||.34
91604304|NCT00988247|183101558|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.3||||0.143|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-0.7|0.143
91790874|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|2.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523322|NCT01060553|182922378|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||for sleep disturbance||||.001
91523323|NCT01060553|182922378|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||for sleep latency||||.015
91523324|NCT01991821|182922383|SUPERIORITY|||||||0.093||||||The complete response of the primary efficacy analysis occurred in 95 patients (56.2%; 95% confidence interval \[CI\] 48.4 - 63.8%) in the APD421 group and 83 patients (46.6%; 95% CI 39.1- 54.2%) in the placebo group|Chi-squared, Corrected|Pearson square test with Yates's continuity correction and with the two- sided significance level of 5%||The primary efficacy analysis was a complete response which is defined as protection from PONV1, which was absence of any episode of emesis, significant nausea or use of rescue medication with the first 24 hours post-operatively.||||0.093
91523325|NCT01991821|182922384|SUPERIORITY|||||||0.059||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.059
91523326|NCT01991821|182922385|SUPERIORITY|||||||0.053||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.053
91523327|NCT01991821|182922386|SUPERIORITY|||||||0.26||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.26
91604305|NCT00988247|183101559|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.49||||0.13|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-1.1|0.130
91523328|NCT01991821|182922387|SUPERIORITY|||||||0.06||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.06
91523329|NCT01991821|182922388|SUPERIORITY|||||||0.079||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.079
91523330|NCT01991821|182922389|SUPERIORITY|||||||0.096|||||||Chi-squared, Corrected|||||||0.096
91523331|NCT03131960|182922392|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
91523332|NCT03131960|182922393|SUPERIORITY|||||||0.0077|||||||ANCOVA|||ANCOVA||||0.0077
91523333|NCT03131960|182922394|SUPERIORITY|||||||0.0098|||||||Regression, Logistic|||||||0.0098
91523334|NCT03131960|182922395|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91523335|NCT01625923|182922399|OTHER|T-test comparing GCSI-DD scores before/after intervention||||||0.06|||||||t-test, 2 sided|||||||.06
91523336|NCT01462162|182922406|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.006
91523337|NCT01462162|182922406|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.000
91523338|NCT01462162|182922406|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
91523339|NCT01462162|182922407|SUPERIORITY_OR_OTHER|||||||0.023|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.023
91523340|NCT01462162|182922407|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.007
91523341|NCT01462162|182922407|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
91523342|NCT01462162|182922408|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 12||||<0.001
91523343|NCT01462162|182922408|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 24||||<0.001
91523344|NCT01462162|182922409|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91523345|NCT01462162|182922409|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91523346|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in DAS-28 at Week 12||||0.003
91523347|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in DAS-28 at Week 24||||0.006
91523348|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.791|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in serum hemoglobin Week 12||||0.791
91650926|NCT01965652|183194506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.29|-0.50|<0.0001
91650927|NCT01965652|183194506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.42|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.20|-0.42|<0.0001
91650928|NCT01965652|183194507|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.5|-0.28|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.28|-0.50|<0.0001
91650929|NCT01965652|183194507|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.44|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Anaysis||-0.20|-0.44|<0.0001
91650930|NCT01965652|183194507|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.4|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.15|-0.40|<0.0001
91650931|NCT01965652|183194507|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.48|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.21|-0.48|<0.0001
91650932|NCT01965652|183194507|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.41|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.15|-0.41|<0.0001
91650933|NCT01965652|183194508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.34|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.34|<0.0001
91650934|NCT01965652|183194508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.35|<0.0001
91650935|NCT01965652|183194508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.14|-0.36|<0.0001
91650936|NCT01965652|183194508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.43|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.19|-0.43|<0.0001
91650937|NCT01965652|183194508|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.061||0.0006|TWO_SIDED|95.0|-0.33|-0.09|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.09|-0.33|0.0006
91790875|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.424||0.528|TWO_SIDED|95.0|-1.103|0.567||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.567|-1.103|0.528
91650938|NCT01965652|183194509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.29|-0.50|<0.0001
91650939|NCT01965652|183194509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.48|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.24|-0.48|<0.0001
91790876|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790877|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.416||0.474|TWO_SIDED|95.0|-0.519|1.116||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.116|-0.519|0.474
91790878|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790879|NCT02880956|183460085|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.429||0.441|TWO_SIDED|95.0|-1.176|0.513||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.513|-1.176|0.441
91790880|NCT02880956|183460085|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|3.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790881|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.331||0.027|TWO_SIDED|95.0|-1.383|-0.082||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.082|-1.383|0.027
91523349|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.847|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in serum hemoglobin Week 24||||0.847
91604306|NCT01169779|183101568|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.0004|TWO_SIDED|95.0|-0.551|-0.162||Statistical testing:2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), sulfonylurea use (Yes,No), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change in HbA1c at Week 24 between lixisenatide arm and placebo arm, 190 patients per group would provide a power of 96% assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.||-0.162|-0.551|0.0004
91604307|NCT00432237|183101579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604308|NCT00432237|183101579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604309|NCT00432237|183101580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604310|NCT00432237|183101580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604311|NCT00432237|183101581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604312|NCT00432237|183101581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604313|NCT00432237|183101582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604314|NCT00432237|183101582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604315|NCT00432237|183101583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604316|NCT00432237|183101583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604317|NCT00432237|183101584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604318|NCT00432237|183101584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604319|NCT00432237|183101585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604320|NCT00432237|183101585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604321|NCT00432237|183101586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604322|NCT00432237|183101586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
91604323|NCT01354132|183101587|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
91523350|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.182|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in swollen joint count Week 12||||0.182
91604324|NCT01354132|183101588|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
91604325|NCT01354132|183101589|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
91604326|NCT01354132|183101590|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
91604327|NCT01354132|183101591|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||Speed of Processing||||0.022
91604328|NCT01354132|183101592|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.270
91604329|NCT01354132|183101593|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
91604330|NCT01354132|183101594|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
91604331|NCT01354132|183101595|SUPERIORITY|||||||0.464|||||||t-test, 2 sided|||||||0.464
91604332|NCT01354132|183101596|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||||||0.741
91604333|NCT01354132|183101597|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91604334|NCT01354132|183101598|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
91604335|NCT01354132|183101599|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
91604336|NCT01354132|183101600|SUPERIORITY|||||||0.6732|||||||t-test, 1 sided|||||||0.6732
91604337|NCT01354132|183101601|SUPERIORITY|||||||0.8786|||||||t-test, 2 sided|||||||0.8786
91604338|NCT01354132|183101602|SUPERIORITY|||||||0.5622|||||||t-test, 2 sided|||||||0.5622
91604339|NCT01354132|183101603|SUPERIORITY|||||||0.9574|||||||t-test, 2 sided|||||||0.9574
91604340|NCT01354132|183101604|SUPERIORITY|||||||0.0043|||||||t-test, 2 sided|||||||0.0043
91604341|NCT01354132|183101605|SUPERIORITY|||||||0.3804|||||||t-test, 2 sided|||||||0.3804
91604342|NCT01354132|183101606|SUPERIORITY|||||||0.9403|||||||t-test, 2 sided|||||||0.9403
91604343|NCT01354132|183101607|SUPERIORITY|||||||0.9215|||||||t-test, 2 sided|||||||0.9215
91604344|NCT00956930|183101608|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.122||||0.007|TWO_SIDED|95.0|0.027|0.557|||Log Rank|||||0.557|0.027|0.007
91523351|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.022|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in swollen joint count Week 24||||0.022
91604345|NCT04355013|183101616|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Bland-Altman for repeated measures|-0.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|95.0|-1.1|0.77||||||Arterial outlet-nasopharyngeal temperatures||0.77|-1.10|
91604346|NCT04355013|183101616|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|-0.63|0.95|||Bland-Altman|||Arterial-venous inflow temperatures||0.95|-0.63|
91604347|NCT04355013|183101616|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.62|STANDARD_DEVIATION|0.69|||TWO_SIDED|95.0|-1.98|0.74|||Bland-Altman|||Arterial outlet-bladder||0.74|-1.98|
91604348|NCT04355013|183101616|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-1.38|1.54|||Bland-Altman|||Arterial outlet- Tcore||1.54|-1.38|
91604349|NCT04355013|183101616|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|0.53|||TWO_SIDED|95.0|-0.73|1.38||||||Nasopharyngeal-venous inflow temperatures||1.38|-0.73|
91604350|NCT04355013|183101616|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.46|STANDARD_DEVIATION|0.52|||TWO_SIDED|95.0|-1.5|0.59||||||Nasopharyngeal-bladder temperatures||0.59|-1.50|
91604351|NCT04355013|183101616|OTHER|Bland-Altman for repeated measures|Bland-Altman for repeated measures|0.24|STANDARD_DEVIATION|0.58|||TWO_SIDED|95.0|-0.9|1.39||||||Nasopharyngeal-Tcore temperatures||1.39|-0.90|
91604352|NCT02348099|183101617|OTHER|"A student's paired t-test will be used to determine the difference if any in CV of Glucose between injection sites. In the third phase, area under the curve will be measured to determine differences between insulin absorption levels. Statistical analysis will be performed using SPSS version 15.0.0 and SAS version 8.2 A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|Odds Ratio (OR)|95.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||"A student's paired t-test will be used to determine the difference if any in CV of glucose between injection sited.~If the null hypothesis is true, it suggests that any changes witnessed in an experiment are because of random chance and not because of changes made to variables in the experiment. A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|a P-Value is \<0.01|||<0.01
91604353|NCT01933932|183101618|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.4355|TWO_SIDED|95.0|0.77|1.12|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.12|0.77|0.4355
91604354|NCT01933932|183101619|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.6431|TWO_SIDED|95.0|0.85|1.3|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.30|0.85|0.6431
91604355|NCT01933932|183101620|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0515|TWO_SIDED|95.0|1.0|2.62|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||2.62|1.00|0.0515
91650940|NCT01965652|183194509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.45|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.21|-0.45|<0.0001
91604356|NCT01933932|183101622|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5007|TWO_SIDED|95.0|0.74|1.86|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||1.86|0.74|0.5007
91604357|NCT01933932|183101623|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.3438|TWO_SIDED|95.0|0.74|1.11|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.11|0.74|0.3438
91604358|NCT00670709|183101624|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-07||95.0|||||t-test, 2 sided|||||||<0.0000001
91604359|NCT00670709|183101625|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005||95.0|||||t-test, 2 sided|||HD subjects vs control subjects||||<0.005
91604360|NCT01261559|183101676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|10.0||0.003|TWO_SIDED|95.0|4.0|25.0|||Regression, Linear|A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.||Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.||25|4|0.003
91604361|NCT01360996|183101693|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
91604362|NCT01360996|183101694|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91604363|NCT01360996|183101695|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91604364|NCT01360996|183101696|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91650941|NCT01965652|183194509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.30|-0.54|<0.0001
91604365|NCT01360996|183101697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||||||<0.0001
91604366|NCT01360996|183101698|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91604367|NCT01360996|183101699|SUPERIORITY_OR_OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
91604368|NCT01656772|183101732|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d = -0.05. The null hypothesis was to be rejected if Z \> 1.645 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0405|TWO_SIDED|||||Adjusted to take into account the correlation between multiple PVs on the same subject. The sample estimate of the intraclass correlation coefficient was calculated as the Pearson sample correlation coefficient for all pairs of observations.|Farrington and Manning|||The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject.||||0.0405
91604369|NCT01656772|183101733|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d= 0.07. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z \< -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0441|TWO_SIDED||||||Z-statistic|||||||.0441
91604370|NCT02730260|183101734|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.||||0.41
91604371|NCT02730260|183101734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.||||<0.03
91650942|NCT01965652|183194509|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.44|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.19|-0.44|<0.0001
91650943|NCT01965652|183194510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.81|-0.53|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.53|-0.81|<0.0001
91650944|NCT01965652|183194510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.73|-0.43|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.43|-0.73|<0.0001
91790882|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|2.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790883|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.328||0.146|TWO_SIDED|95.0|-1.123|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.167|-1.123|0.146
91650945|NCT01965652|183194510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.36|-0.66|<0.0001
91650946|NCT01965652|183194510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.69|-0.38|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.38|-0.69|<0.0001
91650947|NCT01965652|183194510|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.64|-0.32|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.32|-0.64|<0.0001
91650948|NCT01965652|183194511|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91650949|NCT01033864|183194512|SUPERIORITY_OR_OTHER|||||||0.8055|||||||Wilcoxon (Mann-Whitney)|||||||0.8055
91650950|NCT01033864|183194513|SUPERIORITY_OR_OTHER|||||||0.2548|||||||Wilcoxon (Mann-Whitney)|||||||0.2548
91650951|NCT01033864|183194514|SUPERIORITY_OR_OTHER|||||||0.4417|||||||Wilcoxon (Mann-Whitney)|||||||0.4417
91650952|NCT01033864|183194515|SUPERIORITY_OR_OTHER|||||||0.0455|||||||Wilcoxon (Mann-Whitney)|||||||0.0455
91650953|NCT01033864|183194516|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.2300
91650954|NCT01033864|183194517|SUPERIORITY_OR_OTHER|||||||0.0106|||||||Wilcoxon (Mann-Whitney)|||||||0.0106
91790884|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790885|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.335||0.009|TWO_SIDED|95.0|-1.537|-0.22||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.220|-1.537|0.009
91790886|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.31|STANDARD_DEVIATION|2.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790887|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.333||0.952|TWO_SIDED|95.0|-0.674|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.634|-0.674|0.952
91790888|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|3.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790889|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.324||0.764|TWO_SIDED|95.0|-0.54|0.734||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.734|-0.540|0.764
91790890|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.85|||TWO_SIDED|||||||||Week 48||||
91604372|NCT02730260|183101734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.||||<0.03
91604373|NCT01870739|183101735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0616||||0.7324|TWO_SIDED|95.0|-0.4178|0.2947|||Linear Model|Treatment as fixed effect and corresponding baseline as covariate.||||0.2947|-0.4178|0.7324
91604374|NCT01870739|183101736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0371||||0.8614|TWO_SIDED|95.0|-0.4582|0.3839|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.3839|-0.4582|0.8614
91604375|NCT01870739|183101737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0812||||0.7946|TWO_SIDED|95.0|-0.6987|0.5362|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.5362|-0.6987|0.7946
91604376|NCT00961532|183101764|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.||||0.014
91604377|NCT02511522|183101779|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.004
91604378|NCT02511522|183101780|SUPERIORITY|||||||0.068|||||||Log Rank|Stratified Log Rank test adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.068
91604379|NCT02511522|183101781|SUPERIORITY|||||||0.45|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.45
91604380|NCT02511522|183101782|SUPERIORITY|||||||0.07|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.07
91604381|NCT04854499|183101792|SUPERIORITY||Hazard Ratio (HR)|1.314|||||TWO_SIDED|95.0|0.809|2.136|||||HR along with its 2-sided 95% confidence interval (CI) were estimated using the Cox proportional hazards regression model stratified by the stratification factors at randomization.|||2.136|0.809|
91604382|NCT04854499|183101796|SUPERIORITY||Hazard Ratio (HR)|1.094|||||TWO_SIDED|95.0|0.603|1.985||||||||1.985|0.603|
91604383|NCT04854499|183101797|OTHER||Odds Ratio (OR)|0.982|||||TWO_SIDED|95.0|0.449|2.147|||||The 2-sided 95% CI is based on Clopper-Pearson method.|||2.147|0.449|
91604384|NCT04854499|183101797|OTHER||Odds Ratio (OR)|0.943|||||TWO_SIDED|95.0|0.383|2.321|||||The 2-sided 95% CI is based on Clopper-Pearson method.|||2.321|0.383|
91650955|NCT01033864|183194518|SUPERIORITY_OR_OTHER|||||||0.3401|||||||Wilcoxon (Mann-Whitney)|||||||0.3401
91650956|NCT01033864|183194519|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||||||0.0074
91650957|NCT01033864|183194520|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
91650958|NCT02524106|183194522|OTHER||percentage difference|61.0||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
91650959|NCT02524106|183194523|OTHER||percentage difference|39.0||||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
91650960|NCT01121900|183194524|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 80% and 125%.|Mean ratio|39.8|||||TWO_SIDED|90.0|34.4|46.0|||||Test/reference (%)|||46.0|34.4|
91787716|NCT02043899|183455278|OTHER|"1. Exact one-sided binomial test of the null hypothesis (p≤90%) using α=0.05 on \[124I\]mIBG PET/CT SIOPEN consensus scores. If this was accepted and the alternative hypothesis rejected, then trial stopped early for futility.~2. If the null hypothesis was rejected, then a one-sided binomial test of the null hypothesis (p≥97%) was performed (α=0.025). If this was accepted and the alternative hypothesis rejected then the trial stopped early for efficacy."|||||<|0.001||||||Overall design has 82% power and an α of 0.03. Total minimum sample size of 100 lesions was calculated based on a single stage A'hern design with p0 = 0.90 and p1 = 0.97. The overall power and α was calculated based on exact binomial probabilities.|Exact one-sided binomial test||||"For the primary endpoint, a sensitivity analysis was also performed on patients with \<20 positive lesions on \[124I\]mIBG PET/CT to test if few patients with large numbers of positive lesions were affecting the results. The results of the sensitivity analysis were consistent with those of the overall analysis.~Secondary efficacy analysis, separate exact one-sided binomial test of the null hypothesis (p≥97%), performed (α=0.025) performed for skeletal and soft tissue lesions."|||<0.001
91787717|NCT02720107|183455281|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Naïve T cells||||< 0.0001
91787718|NCT02720107|183455281|SUPERIORITY_OR_OTHER|||||||0.0493||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Central memory T cells||||0.0493
91523352|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.163|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in morning stiffness Week 12||||0.163
91604385|NCT02354833|183101824|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
91604386|NCT02354833|183101825|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||This analysis is comparing the percentage of participants with Nausea||||0.28
91604387|NCT02354833|183101825|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This analysis is comparing the percentage of participants with Emesis||||< 0.001
91604388|NCT02354833|183101826|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
91604389|NCT02354833|183101827|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91604390|NCT02157883|183101838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|79.87|||||TWO_SIDED|90.0|73.15|87.21|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||87.21|73.15|
91604391|NCT02157883|183101839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|124.17|||||TWO_SIDED|90.0|114.61|134.53|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||134.53|114.61|
91604392|NCT02157883|183101846|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|75.87|||||TWO_SIDED|90.0|64.18|89.69|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||89.69|64.18|
91604393|NCT02157883|183101847|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.36|124.19|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||124.19|94.36|
91604394|NCT02157883|183101848|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|44.33|||||TWO_SIDED|90.0|39.94|49.21|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||49.21|39.94|
91604395|NCT02157883|183101849|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|49.02|||||TWO_SIDED|90.0|43.7|54.99|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||54.99|43.70|
91604396|NCT05617521|183101869|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients||||||0.008||||||The comparative analysis of the CIT was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||0.008
91604397|NCT05617521|183101870|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.|||||<|0.001||||||For the comparison of abdominal pressure, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||<0.001
91604398|NCT05617521|183101871|SUPERIORITY||||||<|0.001||||||The comparative analysis of the CIL was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||<0.001
91604399|NCT05617521|183101872|SUPERIORITY|||||||0.321|||||||Chi-squared|||||||0.321
91604400|NCT05617521|183101873|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
91604401|NCT05617521|183101874|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
91604402|NCT05617521|183101875|OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
91650961|NCT01121900|183194525|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-tlast) is between 80% and 125%.|Mean ratio|80.9|||||TWO_SIDED|90.0|74.2|88.3|||||Test/reference (%)|||88.3|74.2|
91650962|NCT01121900|183194526|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|83.5|||||TWO_SIDED|90.0|76.5|91.1|||||Test/reference (%)|||91.1|76.5|
91604403|NCT05617521|183101877|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91604404|NCT05617521|183101878|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91650963|NCT00408876|183194537|SUPERIORITY_OR_OTHER|||||||0.503||95.0|||||Repeated Measures|||||||0.503
91650964|NCT00408876|183194537|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||Repeated Measures|||||||0.447
91650965|NCT00408876|183194537|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Repeated Measures|||||||0.084
91650966|NCT00408876|183194537|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Repeated Measures|||||||0.964
91650967|NCT00408876|183194537|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Repeated Measures|||||||0.451
91650968|NCT00408876|183194537|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Repeated Measures|||||||0.333
91650969|NCT00408876|183194538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.318||95.0|-0.62|0.2|||t-test, 2 sided|||||0.20|-0.62|0.318
91650970|NCT00408876|183194538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.005||95.0|-0.83|-0.15|||t-test, 2 sided|||||-0.15|-0.83|0.005
91650971|NCT00408876|183194538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.124||95.0|-0.61|0.07|||t-test, 2 sided|||||0.07|-0.61|0.124
91650972|NCT00408876|183194538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.183||95.0|-0.7|0.13|||t-test, 2 sided|||||0.13|-0.70|0.183
91650973|NCT00408876|183194538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.778||95.0|-0.48|0.36|||t-test, 2 sided|||||0.36|-0.48|0.778
91604405|NCT05617521|183101879|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91604406|NCT05617521|183101880|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.||||||0.01||||||For the comparison of position change, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||0.01
91604407|NCT05617521|183101881|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91604408|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|12.9|||<|0.001|TWO_SIDED|95.0|9.5|16.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||16.3|9.5|<0.001
91604409|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.6|||<|0.001|TWO_SIDED|95.0|4.4|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.4|<0.001
91604410|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|10.8|||<|0.001|TWO_SIDED|95.0|7.4|14.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||14.2|7.4|<0.001
91604411|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.8|||<|0.001|TWO_SIDED|95.0|4.6|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.6|<0.001
91523353|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.115|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in morning stiffness Week 24||||0.115
91604412|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|7.6|||<|0.001|TWO_SIDED|95.0|4.2|11.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||11.0|4.2|<0.001
91604413|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|10.4|||<|0.001|TWO_SIDED|95.0|7.2|13.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||13.6|7.2|<0.001
91604414|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|5.2||||0.002|TWO_SIDED|95.0|1.9|8.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.6|1.9|0.002
91604415|NCT00792298|183101883|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|4.7||||0.003|TWO_SIDED|95.0|1.6|7.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.8|1.6|0.003
91604416|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-36.8|||<|0.001|TWO_SIDED|95.0|-49.4|-24.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-24.3|-49.4|<0.001
91604417|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.9|||<|0.001|TWO_SIDED|95.0|-42.1|-15.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.7|-42.1|<0.001
91604418|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-33.9|||<|0.001|TWO_SIDED|95.0|-46.4|-21.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-21.5|-46.4|<0.001
91604419|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-33.2|||<|0.001|TWO_SIDED|95.0|-46.3|-20.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-20.2|-46.3|<0.001
91604420|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-24.7|||<|0.001|TWO_SIDED|95.0|-37.1|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-37.1|<0.001
91650974|NCT00408876|183194538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.21||95.0|-0.13|0.57|||t-test, 2 sided|||||0.57|-0.13|0.210
91523354|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.037|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in degree of pain Week 12||||0.037
91650975|NCT00408876|183194539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.161||95.0|-2.32|0.39|||t-test, 2 sided|||||0.39|-2.32|0.161
91650976|NCT00408876|183194539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.019||95.0|-2.59|-0.24|||t-test, 2 sided|||||-0.24|-2.59|0.019
91650977|NCT00408876|183194539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.01||95.0|-2.74|-0.38|||t-test, 2 sided|||||-0.38|-2.74|0.010
91604421|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.1|||<|0.001|TWO_SIDED|95.0|-41.0|-15.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.1|-41.0|<0.001
91604422|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-21.2|||<|0.001|TWO_SIDED|95.0|-33.5|-8.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.8|-33.5|<0.001
91604423|NCT00792298|183101884|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-21.4||||0.001|TWO_SIDED|95.0|-34.2|-8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.7|-34.2|0.001
91604424|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-25.4|||<|0.001|TWO_SIDED|95.0|-37.7|-13.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-13.1|-37.7|<0.001
91604425|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-9.5||||0.068|TWO_SIDED|95.0|-19.7|0.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.7|-19.7|0.068
91604426|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-23.1|||<|0.001|TWO_SIDED|95.0|-35.3|-10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-10.9|-35.3|<0.001
91604427|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-3.8||||0.459|TWO_SIDED|95.0|-13.8|6.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||6.3|-13.8|0.459
91604428|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-9.4||||0.13|TWO_SIDED|95.0|-21.5|2.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||2.8|-21.5|0.130
91650978|NCT00408876|183194539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.526||95.0|-1.83|0.94|||t-test, 2 sided|||||0.94|-1.83|0.526
91523355|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.044|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in degree of pain Week 24||||0.044
91523356|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in sleepiness at Week 12||||0.003
91523357|NCT01462162|182922410|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in sleepiness at Week 24||||0.001
91523358|NCT01462162|182922410|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in depression Week 12||||<0.001
91604429|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-22.3|||<|0.001|TWO_SIDED|95.0|-32.3|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-32.3|<0.001
91604430|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-3.4||||0.577|TWO_SIDED|95.0|-15.6|8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.7|-15.6|0.577
91604431|NCT00792298|183101885|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-2.3||||0.644|TWO_SIDED|95.0|-12.2|7.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.5|-12.2|0.644
91604432|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-22.3||||0.007|TWO_SIDED|95.0|-38.3|-6.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-6.2|-38.3|0.007
91650979|NCT00408876|183194539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.397||95.0|-1.96|0.78|||t-test, 2 sided|||||0.78|-1.96|0.397
91650980|NCT00408876|183194539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.813||95.0|-1.35|1.06|||t-test, 2 sided|||||1.06|-1.35|0.813
91650981|NCT00408876|183194540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.657||95.0|-0.5|0.79|||t-test, 2 sided|||||0.79|-0.50|0.657
91650982|NCT00408876|183194540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.384||95.0|-0.76|0.29|||t-test, 2 sided|||||0.29|-0.76|0.384
91650983|NCT00408876|183194540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.04||95.0|-1.1|-0.03|||t-test, 2 sided|||||-0.03|-1.10|0.040
91650984|NCT00408876|183194540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.253||95.0|-1.03|0.27|||t-test, 2 sided|||||0.27|-1.03|0.253
91650985|NCT00408876|183194540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.034||95.0|-1.36|-0.05|||t-test, 2 sided|||||-0.05|-1.36|0.034
91650986|NCT00408876|183194540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.232||95.0|-0.86|0.21|||t-test, 2 sided|||||0.21|-0.86|0.232
91650987|NCT00408876|183194541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.365||95.0|-0.39|1.05|||t-test, 2 sided|||||1.05|-0.39|0.365
91523359|NCT01462162|182922410|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in depression at Week 24||||<0.001
91523360|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.678|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.678
91523361|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.348|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.348
91604433|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-19.6||||0.024|TWO_SIDED|95.0|-36.6|-2.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-2.6|-36.6|0.024
91604434|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-31.0|||<|0.001|TWO_SIDED|95.0|-46.9|-15.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.2|-46.9|<0.001
91523362|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.679|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.679
91604435|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-15.7||||0.063|TWO_SIDED|95.0|-32.3|0.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.8|-32.3|0.063
91604436|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-17.4||||0.03|TWO_SIDED|95.0|-33.1|-1.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-1.7|-33.1|0.030
91604437|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-24.6||||0.003|TWO_SIDED|95.0|-41.0|-8.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.3|-41.0|0.003
91650988|NCT00408876|183194541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.232||95.0|-0.95|0.23|||t-test, 2 sided|||||0.23|-0.95|0.232
91650989|NCT00408876|183194541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.314||95.0|-0.9|0.29|||t-test, 2 sided|||||0.29|-0.90|0.314
91650990|NCT00408876|183194541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.062||95.0|-1.41|0.03|||t-test, 2 sided|||||0.03|-1.41|0.062
91650991|NCT00408876|183194541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.083||95.0|-1.36|0.08|||t-test, 2 sided|||||0.08|-1.36|0.083
91650992|NCT00408876|183194541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.859||95.0|-0.54|0.65|||t-test, 2 sided|||||0.65|-0.54|0.859
91650993|NCT00408876|183194542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.984||95.0|-0.34|0.34|||t-test, 2 sided|||||0.34|-0.34|0.984
91650994|NCT00408876|183194542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.004||95.0|-0.7|-0.13|||t-test, 2 sided|||||-0.13|-0.70|0.004
91650995|NCT00408876|183194542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.81|-0.24|||t-test, 2 sided|||||-0.24|-0.81|<0.001
91650996|NCT00408876|183194542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.018||95.0|-0.76|-0.07|||t-test, 2 sided|||||-0.07|-0.76|0.018
91650997|NCT00408876|183194542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.003||95.0|-0.87|-0.19|||t-test, 2 sided|||||-0.19|-0.87|0.003
91650998|NCT00408876|183194542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.442||95.0|-0.4|0.17|||t-test, 2 sided|||||0.17|-0.40|0.442
91650999|NCT00408876|183194543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.464||95.0|-0.52|1.14|||t-test, 2 sided|||||1.14|-0.52|0.464
91651000|NCT00408876|183194543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.36|0.0|||t-test, 2 sided|||||0.00|-1.36|0.052
91651001|NCT00408876|183194543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.37|0.01|||t-test, 2 sided|||||0.01|-1.37|0.052
91651002|NCT00408876|183194543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.021||95.0|-1.83|-0.15|||t-test, 2 sided|||||-0.15|-1.83|0.021
91787719|NCT02720107|183455281|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Effector memory T cells||||< 0.0001
91523363|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.556|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.556
91604438|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-19.1||||0.02|TWO_SIDED|95.0|-35.1|-3.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.0|-35.1|0.020
91604439|NCT00792298|183101886|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-20.2||||0.019|TWO_SIDED|95.0|-37.0|-3.4|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.4|-37.0|0.019
91604440|NCT02649634|183101888|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05.|Mixed Models Analysis|||Linear mixed modelling (LMM) was used||||>.05
91604441|NCT02649634|183101889|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
91604442|NCT02649634|183101890|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.||||||0.65|||||||t-test, 2 sided|||Treatment adherence was analyzed via an independent sample t-test comparing the groups on mean number of TrymGym sessions missed.||||.65
91651003|NCT00408876|183194543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.02||95.0|-1.83|-0.16|||t-test, 2 sided|||||-0.16|-1.83|0.020
91651004|NCT00408876|183194543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.988||95.0|-0.7|0.69|||t-test, 2 sided|||||0.69|-0.70|0.988
91787720|NCT02720107|183455281|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Naïve T cells||||< 0.0001
91523364|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.692|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 12)||||0.692
91651005|NCT00408876|183194544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.543||95.0|-0.46|0.88|||t-test, 2 sided|||||0.88|-0.46|0.543
91651006|NCT00408876|183194544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.053||95.0|-1.1|0.01|||t-test, 2 sided|||||0.01|-1.10|0.053
91651007|NCT00408876|183194544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.024||95.0|-1.21|-0.09|||t-test, 2 sided|||||-0.09|-1.21|0.024
91651008|NCT00408876|183194544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75||||0.03||95.0|-1.43|-0.07|||t-test, 2 sided|||||-0.07|-1.43|0.030
91523365|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.771|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 24)||||0.771
91604443|NCT02649634|183101891|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
91604444|NCT02649634|183101892|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
91604445|NCT02649634|183101893|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604446|NCT02649634|183101894|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604447|NCT02649634|183101895|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604448|NCT02649634|183101896|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604449|NCT02649634|183101897|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91651009|NCT00408876|183194544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.014||95.0|-1.54|-0.17|||t-test, 2 sided|||||-0.17|-1.54|0.014
91651010|NCT00408876|183194544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.727||95.0|-0.66|0.46|||t-test, 2 sided|||||0.46|-0.66|0.727
91651011|NCT00408876|183194545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.813||95.0|-0.63|0.8|||t-test, 2 sided|||||0.80|-0.63|0.813
91651012|NCT00408876|183194545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.035||95.0|-1.21|-0.04|||t-test, 2 sided|||||-0.04|-1.21|0.035
91651013|NCT00408876|183194545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.054||95.0|-1.17|0.01|||t-test, 2 sided|||||0.01|-1.17|0.054
91651014|NCT00408876|183194545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.051||95.0|-1.43|0.0|||t-test, 2 sided|||||0.00|-1.43|0.051
91651015|NCT00408876|183194545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.07||95.0|-1.39|0.05|||t-test, 2 sided|||||0.05|-1.39|0.070
91651016|NCT00408876|183194545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.872||95.0|-0.54|0.64|||t-test, 2 sided|||||0.64|-0.54|0.872
91651017|NCT00408876|183194546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.79||95.0|-0.68|0.89|||t-test, 2 sided|||||0.89|-0.68|0.790
91651018|NCT00408876|183194546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.005||95.0|-1.57|-0.28|||t-test, 2 sided|||||-0.28|-1.57|0.005
91604450|NCT02649634|183101898|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604451|NCT02649634|183101899|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604452|NCT02649634|183101900|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604453|NCT02649634|183101901|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604454|NCT02649634|183101902|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604455|NCT02649634|183101903|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
91604456|NCT02649634|183101904|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
91604457|NCT02649634|183101905|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
91604458|NCT02649634|183101906|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
91604459|NCT02649634|183101907|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
91651019|NCT00408876|183194546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.009||95.0|-1.52|-0.22|||t-test, 2 sided|||||-0.22|-1.52|0.009
91651020|NCT00408876|183194546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.011||95.0|-1.83|-0.24|||t-test, 2 sided|||||-0.24|-1.83|0.011
91651021|NCT00408876|183194546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.016||95.0|-1.77|-0.18|||t-test, 2 sided|||||-0.18|-1.77|0.016
91651022|NCT00408876|183194546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.857||95.0|-0.6|0.72|||t-test, 2 sided|||||0.72|-0.60|0.857
91651023|NCT00408876|183194547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.948||95.0|-0.81|0.76|||t-test, 2 sided|||||0.76|-0.81|0.948
91651024|NCT00408876|183194547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.096||95.0|-1.2|0.1|||t-test, 2 sided|||||0.10|-1.20|0.096
91651025|NCT00408876|183194547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.239||95.0|-1.05|0.26|||t-test, 2 sided|||||0.26|-1.05|0.239
91523366|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.878|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 12)||||0.878
91651026|NCT00408876|183194547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.196||95.0|-1.32|0.27|||t-test, 2 sided|||||0.27|-1.32|0.196
91651027|NCT00408876|183194547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.367||95.0|-1.17|0.43|||t-test, 2 sided|||||0.43|-1.17|0.367
91651028|NCT00408876|183194547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.637||95.0|-0.5|0.82|||t-test, 2 sided|||||0.82|-0.50|0.637
91651029|NCT00408876|183194548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.887||95.0|-0.76|0.65|||t-test, 2 sided|||||0.65|-0.76|0.887
91604460|NCT02649634|183101908|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
91604461|NCT02649634|183101909|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
91604462|NCT02649634|183101910|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
91604463|NCT02649634|183101911|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
91604464|NCT02649634|183101912|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
91604465|NCT02649634|183101913|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
91651030|NCT00408876|183194548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.006||95.0|-1.4|-0.23|||t-test, 2 sided|||||-0.23|-1.40|0.006
91651031|NCT00408876|183194548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.392||95.0|-0.84|0.33|||t-test, 2 sided|||||0.33|-0.84|0.392
91651032|NCT00408876|183194548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.036||95.0|-1.48|-0.05|||t-test, 2 sided|||||-0.05|-1.48|0.036
91604466|NCT02706938|183101942|OTHER|One tail paired t test.|Mean Difference (Final Values)|1.3267|STANDARD_DEVIATION|2.1604||0.0002|TWO_SIDED|95.0|0.6263|2.027||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||2.0270|0.6263|0.0002
91604467|NCT02706938|183101942|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.359||||0.0082|TWO_SIDED|95.0|-0.6255|-0.0924||A priori threshold for statistical significance was 0.05|McNemar|||||-0.0924|-0.6255|0.0082
91604468|NCT02706938|183101943|OTHER|One tail paired t test.|Mean Difference (Final Values)|-6.9131|STANDARD_DEVIATION|32.5093||0.099|TWO_SIDED|95.0|-17.5987|3.7724||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||3.7724|-17.5987|0.099
91651033|NCT00408876|183194548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.573||95.0|-0.92|0.51|||t-test, 2 sided|||||0.51|-0.92|0.573
91651034|NCT00408876|183194548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.064||95.0|-0.03|1.15|||t-test, 2 sided|||||1.15|-0.03|0.064
91651035|NCT00408876|183194549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.374||95.0|-1.15|0.43|||t-test, 2 sided|||||0.43|-1.15|0.374
91651036|NCT00408876|183194549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.007||95.0|-1.55|-0.25|||t-test, 2 sided|||||-0.25|-1.55|0.007
91651037|NCT00408876|183194549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.169||95.0|-1.12|0.2|||t-test, 2 sided|||||0.20|-1.12|0.169
91604469|NCT02706938|183101943|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.0263||||0.8084|TWO_SIDED|95.0|-0.2651|0.2125||A priori threshold for statistical significance was 0.05|McNemar|||||0.2125|-0.2651|0.8084
91523367|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.139|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 24)||||0.139
91604470|NCT03377634|183101952|OTHER|Analysis of covariance on change in PROMIS Pain intensity, with group as fixed effect and controlling for baseline pain intensity||||||0.11|||||||ANCOVA|||||||0.11
91604471|NCT03377634|183101953|OTHER|Analysis of covariance on change in PROMIS pain interference, with group as fixed effect and controlling for baseline pain interference||||||0.99|||||||ANCOVA|||||||.99
91604472|NCT03377634|183101954|OTHER|Analysis of covariance on change in SPPB, with group as fixed effect and controlling for baseline SPPB||||||0.14|||||||ANCOVA|||||||.14
91604473|NCT03377634|183101955|OTHER|Analysis of covariance on change in weight, with group as fixed effect and controlling for baseline weight||||||0.11|||||||ANCOVA|||||||.11
91604474|NCT03377634|183101956|OTHER|Analysis of covariance on change in activity time, with group as fixed effect and controlling for baseline stepping time||||||0.65|||||||ANCOVA|||||||.65
91604475|NCT03377634|183101957|OTHER|Analysis of covariance on change in sitting time, with group as fixed effect and controlling for baseline sitting time||||||0.41|||||||ANCOVA|||||||.41
91604476|NCT03377634|183101958|OTHER|Analysis of covariance on change in sit to stand transitions, with group as fixed effect and controlling for baseline transitions||||||0.28|||||||ANCOVA|||||||.28
91604477|NCT00584870|183101980|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.39||0.001|TWO_SIDED|80.0|-1.67|-0.67||p-value was based on repeated measures model from pairwise comparisons, and statistical test was 1-sided with 0.1 significance level.|Repeated Measures Model|||LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect.||-0.67|-1.67|0.001
91604478|NCT01015833|183102050|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.24|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|||||1.4|0.8|0.24
91604479|NCT01015833|183102052|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.98|TWO_SIDED|95.0|0.72|1.2|||t-test, 1 sided|||||1.2|0.72|0.98
91604480|NCT04743856|183102101|OTHER|||||||0.63||||||Apriori p-value for significance was \<0.05. Models were not adjusted for additional covariates and multiple comparisons adjustment was not performed.|Mixed Models Analysis|Mixed models for binomial outcomes were run to determine if there were significant differences in meeting goal over time.||||||0.63
91604481|NCT04743856|183102102|OTHER||Mean Difference (Final Values)|-1106.28|STANDARD_ERROR_OF_MEAN|592.76||0.0665||||||Apriori significance level was p\<0.05. No adjustment for multiple comparisons was made.|Mixed Models Analysis|Models were not adjusted for additional variables.||||||0.0665
91604482|NCT04696861|183102118|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
91604483|NCT04696861|183102119|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
91604484|NCT04696861|183102120|SUPERIORITY|||||||0.368||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.368
91604485|NCT04696861|183102122|SUPERIORITY|||||||0.634||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.634
91523368|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.249|||||||Regression, Linear|||change in haemoglobin levels versus change in depression score (Week 12)||||0.249
91523369|NCT01462162|182922411|SUPERIORITY_OR_OTHER|||||||0.61|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.610
91523370|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.257|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 12)||||0.257
91604486|NCT04696861|183102123|SUPERIORITY|||||||0.832||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.832
91604487|NCT04696861|183102125|SUPERIORITY|||||||0.624||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.624
91604488|NCT04696861|183102126|SUPERIORITY|||||||0.833||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.833
91604489|NCT04696861|183102127|SUPERIORITY|||||||0.7||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.7
91651038|NCT00408876|183194549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.182||95.0|-1.35|0.26|||t-test, 2 sided|||||0.26|-1.35|0.182
91604490|NCT04696861|183102128|SUPERIORITY|||||||0.79||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.79
91604491|NCT04696861|183102129|SUPERIORITY|||||||0.55||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.55
91604492|NCT04696861|183102130|SUPERIORITY|||||||0.823|||||||Mixed Models Analysis|||||||.823
91604493|NCT04696861|183102131|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||.942
91604494|NCT04696861|183102132|SUPERIORITY|||||||0.207||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.207
91604495|NCT04696861|183102133|SUPERIORITY|||||||0.594||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.594
91604496|NCT04696861|183102134|SUPERIORITY|||||||0.738||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.738
91604497|NCT04696861|183102135|SUPERIORITY|||||||0.845||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.845
91604498|NCT01813890|183102143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|105.61||||0.006|TWO_SIDED|95.0|32.0|179.2||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||179.2|32.0|0.006
91604499|NCT01813890|183102143|SUPERIORITY_OR_OTHER||Median Difference (Net)|126.58||||0.004|TWO_SIDED|95.0|49.5|203.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||203.7|49.5|0.004
91523371|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.487|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 24)||||0.487
91604500|NCT03952559|183102157|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7261|TWO_SIDED|95.0|0.58|2.21|||Regression, Logistic|||||2.21|0.58|0.7261
91604501|NCT03952559|183102157|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0718|TWO_SIDED|95.0|0.95|3.41|||Regression, Logistic|||||3.41|0.95|0.0718
91604502|NCT03952559|183102157|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.0001|TWO_SIDED|95.0|2.02|6.89|||Regression, Logistic|||||6.89|2.02|<0.0001
91604503|NCT03952559|183102160|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9615|TWO_SIDED|95.0|0.59|1.74|||Regression, Logistic|||||1.74|0.59|0.9615
91604504|NCT03952559|183102160|SUPERIORITY||Odds Ratio (OR)|1.42||||0.201|TWO_SIDED|95.0|0.83|2.41|||Regression, Logistic|||||2.41|0.83|0.2010
91604505|NCT03952559|183102160|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0017|TWO_SIDED|95.0|1.38|3.95|||Regression, Logistic|||||3.95|1.38|0.0017
91604506|NCT03952559|183102161|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8544|TWO_SIDED|95.0|0.43|2.01|||Regression, Logistic|||||2.01|0.43|0.8544
91604507|NCT03952559|183102161|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0561|TWO_SIDED|95.0|0.98|3.91|||Regression, Logistic|||||3.91|0.98|0.0561
91604508|NCT03952559|183102161|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0012|TWO_SIDED|95.0|1.54|5.82|||Regression, Logistic|||||5.82|1.54|0.0012
91604509|NCT03952559|183102162|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.349||0.2627|TWO_SIDED|95.0|-4.16|1.14|||Mixed Models Analysis|||||1.14|-4.16|0.2627
91604510|NCT03952559|183102162|SUPERIORITY||LS Mean difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.342||0.2135|TWO_SIDED|95.0|-4.31|0.97|||Mixed Models Analysis|||||0.97|-4.31|0.2135
91604511|NCT03952559|183102162|SUPERIORITY||LS Mean difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.347||0.0443|TWO_SIDED|95.0|-5.36|-0.07|||Mixed Models Analysis|||||-0.07|-5.36|0.0443
91604512|NCT03952559|183102163|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4943|TWO_SIDED|95.0|0.3|1.78|||Regression, Logistic|||||1.78|0.30|0.4943
91604513|NCT03952559|183102163|SUPERIORITY||Odds Ratio (OR)|1.72||||0.1677|TWO_SIDED|95.0|0.8|3.7|||Regression, Logistic|||||3.70|0.80|0.1677
91604514|NCT03952559|183102163|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0336|TWO_SIDED|95.0|1.06|4.7|||Regression, Logistic|||||4.70|1.06|0.0336
91523372|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.644|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.644
91604515|NCT03952559|183102164|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8866|TWO_SIDED|95.0|0.42|2.77|||Regression, Logistic|||||2.77|0.42|0.8866
91604516|NCT03952559|183102164|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2316|TWO_SIDED|95.0|0.7|4.26|||Regression, Logistic|||||4.26|0.70|0.2316
91604517|NCT03952559|183102164|SUPERIORITY||Odds Ratio, log|2.59||||0.0328|TWO_SIDED|95.0|1.08|6.22|||Regression, Logistic|||||6.22|1.08|0.0328
91604518|NCT03952559|183102165|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5361|TWO_SIDED|95.0|0.7|1.98|||Regression, Logistic|||||1.98|0.70|0.5361
91604519|NCT03952559|183102165|SUPERIORITY||Odds Ratio (OR)|1.23||||0.4417|TWO_SIDED|95.0|0.73|2.06|||Regression, Logistic|||||2.06|0.73|0.4417
91604520|NCT03952559|183102165|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0121|TWO_SIDED|95.0|1.16|3.43|||Regression, Logistic|||||3.43|1.16|0.0121
91604521|NCT03952559|183102166|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7706|TWO_SIDED|95.0|0.37|3.78|||Regression, Logistic|||||3.78|0.37|0.7706
91604522|NCT03952559|183102166|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7409|TWO_SIDED|95.0|0.38|3.86|||Regression, Logistic|||||3.86|0.38|0.7409
91604523|NCT03952559|183102166|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0253|TWO_SIDED|95.0|1.15|8.63|||Regression, Logistic|||||8.63|1.15|0.0253
91604524|NCT03952559|183102167|SUPERIORITY||LS Mean difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|2.576||0.1317|TWO_SIDED|95.0|-8.95|1.17|||Mixed Models Analysis|||||1.17|-8.95|0.1317
91604525|NCT03952559|183102167|SUPERIORITY||LS Mean difference (Final Values)|-5.15|STANDARD_ERROR_OF_MEAN|2.564||0.0451|TWO_SIDED|95.0|-10.19|-0.11|||Mixed Models Analysis|||||-0.11|-10.19|0.0451
91604526|NCT03952559|183102167|SUPERIORITY||LS Mean difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.566||0.0031|TWO_SIDED|95.0|-12.66|-2.58|||Mixed Models Analysis|||||-2.58|-12.66|0.0031
91604527|NCT03952559|183102168|SUPERIORITY||Odds Ratio (OR)|0.53||||0.4238|TWO_SIDED|95.0|0.11|2.49|||Regression, Logistic|||||2.49|0.11|0.4238
91604528|NCT03952559|183102168|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5118|TWO_SIDED|95.0|0.44|5.08|||Regression, Logistic|||||5.08|0.44|0.5118
91604529|NCT03952559|183102168|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0129|TWO_SIDED|95.0|1.34|11.52|||Regression, Logistic|||||11.52|1.34|0.0129
91604530|NCT03952559|183102169|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.168||0.4852|TWO_SIDED|95.0|-5.77|2.75|||Mixed Models Analysis|||||2.75|-5.77|0.4852
91604531|NCT03952559|183102169|SUPERIORITY||LS Mean difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.16||0.4205|TWO_SIDED|95.0|-5.98|2.5|||Mixed Models Analysis|||||2.50|-5.98|0.4205
91604532|NCT03952559|183102169|SUPERIORITY||LS Mean difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.161||0.0138|TWO_SIDED|95.0|-9.59|-1.1|||Mixed Models Analysis|||||-1.10|-9.59|0.0138
91604533|NCT03952559|183102170|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91604534|NCT03952559|183102170|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.540
91604535|NCT03952559|183102170|SUPERIORITY|||||||0.302|||||||Fisher Exact|||||||0.302
91604536|NCT03952559|183102171|SUPERIORITY||LS Mean difference (Final Values)|4.47|STANDARD_ERROR_OF_MEAN|5.03||0.375|TWO_SIDED|95.0|-5.41|14.35|||ANOVA|||||14.35|-5.41|0.375
91604537|NCT03952559|183102171|SUPERIORITY||LS Mean difference (Final Values)|3.12|STANDARD_ERROR_OF_MEAN|5.03||0.536|TWO_SIDED|95.0|-6.76|13.0|||ANOVA|||||13.00|-6.76|0.536
91604538|NCT03952559|183102171|SUPERIORITY||LS Mean difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|5.03||0.016|TWO_SIDED|95.0|2.29|22.05|||ANOVA|||||22.05|2.29|0.016
91604539|NCT03952559|183102172|SUPERIORITY||LS Mean difference (Final Values)|-49.19|STANDARD_ERROR_OF_MEAN|27.28||0.073|TWO_SIDED|95.0|-102.81|4.42|||ANOVA|||||4.42|-102.81|0.073
91604540|NCT03952559|183102172|SUPERIORITY||LS Mean difference (Final Values)|-37.38|STANDARD_ERROR_OF_MEAN|27.29||0.172|TWO_SIDED|95.0|-91.0|16.23|||ANOVA|||||16.23|-91.00|0.172
91604541|NCT03952559|183102172|SUPERIORITY||LS Mean difference (Final Values)|-80.37|STANDARD_ERROR_OF_MEAN|27.28||0.004|TWO_SIDED|95.0|-133.98|-26.75|||ANOVA|||||-26.75|-133.98|0.004
91604542|NCT03952559|183102173|SUPERIORITY||LS Mean difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.372||0.0829|TWO_SIDED|95.0|-1.38|0.08|||Mixed Models Analysis|||||0.08|-1.38|0.0829
91604543|NCT03952559|183102173|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.368||0.1752|TWO_SIDED|95.0|-1.22|0.22|||Mixed Models Analysis|||||0.22|-1.22|0.1752
91604544|NCT03952559|183102173|SUPERIORITY||LS Mean difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.366||0.0029|TWO_SIDED|95.0|-1.82|-0.38|||Mixed Models Analysis|||||-0.38|-1.82|0.0029
91604545|NCT03952559|183102174|SUPERIORITY||LS Mean difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.193||0.2688|TWO_SIDED|95.0|-0.6|0.17|||Mixed Models Analysis|||||0.17|-0.60|0.2688
91604546|NCT03952559|183102174|SUPERIORITY||LS Mean difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.193||0.0166|TWO_SIDED|95.0|-0.85|-0.09|||Mixed Models Analysis|||||-0.09|-0.85|0.0166
91604547|NCT03952559|183102174|SUPERIORITY||LS Mean difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0908|TWO_SIDED|95.0|-0.75|0.06|||Mixed Models Analysis|||||0.06|-0.75|0.0908
91604548|NCT03952559|183102175|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.956||0.3409|TWO_SIDED|95.0|-2.79|0.97|||Mixed Models Analysis|||||0.97|-2.79|0.3409
91604549|NCT03952559|183102175|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.952||0.1022|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1022
91604550|NCT03952559|183102175|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.953||0.1024|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1024
91604551|NCT03952559|183102176|SUPERIORITY||LS Mean difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.157||0.1436|TWO_SIDED|95.0|-0.54|0.08|||Mixed Models Analysis|||||0.08|-0.54|0.1436
91604552|NCT03952559|183102176|SUPERIORITY||LS Mean difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.154||0.0483|TWO_SIDED|95.0|-0.61|0.0|||Mixed Models Analysis|||||-0.00|-0.61|0.0483
91604553|NCT03952559|183102176|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.154||0.0012|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||||-0.20|-0.80|0.0012
91604554|NCT03952559|183102177|SUPERIORITY||LS Mean difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.755||0.9183|TWO_SIDED|95.0|-3.27|3.63|||Mixed Models Analysis|||for 8 to \<18 years old||3.63|-3.27|0.9183
91604555|NCT03952559|183102177|SUPERIORITY||LS Mean difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.529||0.4805|TWO_SIDED|95.0|-4.09|1.93|||Mixed Models Analysis|||for 8 to \<18 years old||1.93|-4.09|0.4805
91604556|NCT03952559|183102177|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.812||0.3488|TWO_SIDED|95.0|-5.26|1.86|||Mixed Models Analysis|||for 8 to \<18 years old||1.86|-5.26|0.3488
91604557|NCT03952559|183102177|SUPERIORITY||LS Mean difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|3.12||0.2388|TWO_SIDED|95.0|-4.85|7.66|||Mixed Models Analysis|||for 5 to \<8 years old||7.66|-4.85|0.2388
91604558|NCT03952559|183102177|SUPERIORITY||LS Mean difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|3.542||0.0098|TWO_SIDED|95.0|-10.23|3.98|||Mixed Models Analysis|||for 5 to \<8 years old||3.98|-10.23|0.0098
91604559|NCT03952559|183102177|SUPERIORITY||LS Mean difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.14||0.1698|TWO_SIDED|95.0|-5.18|7.42|||Mixed Models Analysis|||for 5 to \<8 years old||7.42|-5.18|0.1698
91604560|NCT03952559|183102178|SUPERIORITY||LS Mean difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|1.813||0.8611|TWO_SIDED|95.0|-3.24|3.88|||Mixed Models Analysis|||for 8 to \<18 years old||3.88|-3.24|0.8611
91523373|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.498|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.498
91604561|NCT03952559|183102178|SUPERIORITY||LS Mean difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|1.571||0.5098|TWO_SIDED|95.0|-4.12|2.05|||Mixed Models Analysis|||for 8 to \<18 years old||2.05|-4.12|0.5098
91604562|NCT03952559|183102178|SUPERIORITY||LS Mean difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.87||0.1997|TWO_SIDED|95.0|-6.08|1.27|||Mixed Models Analysis|||for 8 to \<18 years old||1.27|-6.08|0.1997
91604563|NCT03952559|183102178|SUPERIORITY||LS Mean difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|3.351||0.1957|TWO_SIDED|95.0|-5.11|8.35|||Mixed Models Analysis|||for 5 to \<8 years old||8.35|-5.11|0.1957
91604564|NCT03952559|183102178|SUPERIORITY||LS Mean difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|3.864||0.0881|TWO_SIDED|95.0|-8.19|7.32|||Mixed Models Analysis|||for 5 to \<8 years old||7.32|-8.19|0.0881
91604565|NCT03952559|183102178|SUPERIORITY||LS Mean difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.379||0.1604|TWO_SIDED|95.0|-5.27|8.28|||Mixed Models Analysis|||for 5 to \<8 years old||8.28|-5.27|0.1604
91604566|NCT03952559|183102179|SUPERIORITY||LS Mean difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.647||0.2987|TWO_SIDED|95.0|-1.93|0.59|||Mixed Models Analysis|||||0.59|-1.93|0.2987
91604567|NCT03952559|183102179|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.632||0.3096|TWO_SIDED|95.0|-1.88|0.6|||Mixed Models Analysis|||||0.60|-1.88|0.3096
91523374|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||change in hemoglobin levels versus change in degree of pain (Week 12)||||0.650
91604568|NCT03952559|183102179|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.635||0.6341|TWO_SIDED|95.0|-1.55|0.95|||Mixed Models Analysis|||||0.95|-1.55|0.6341
91604569|NCT03952559|183102180|SUPERIORITY||LS Mean difference (Final Values)|5.27|STANDARD_ERROR_OF_MEAN|4.323||0.2871|TWO_SIDED|95.0|-6.54|17.09|||Mixed Models Analysis|||||17.09|-6.54|0.2871
91604570|NCT03952559|183102180|SUPERIORITY||LS Mean difference (Final Values)|4.73|STANDARD_ERROR_OF_MEAN|3.835||0.3093|TWO_SIDED|95.0|-7.83|17.29|||Mixed Models Analysis|||||17.29|-7.83|0.3093
91604571|NCT03952559|183102180|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.788||0.2912|TWO_SIDED|95.0|-18.22|8.21|||Mixed Models Analysis|||||8.21|-18.22|0.2912
91604572|NCT03952559|183102181|SUPERIORITY|Absenteeism Change from Baseline|LS Mean difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|3.119||0.6079|TWO_SIDED|95.0|-7.74|4.54|||Mixed Models Analysis|||||4.54|-7.74|0.6079
91604573|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|3.092||0.5492|TWO_SIDED|95.0|-7.94|4.24|||Mixed Models Analysis|||Absenteeism Change from Baseline||4.24|-7.94|0.5492
91604574|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|3.281||0.1338|TWO_SIDED|95.0|-11.39|1.53|||Mixed Models Analysis|||Absenteeism Change from Baseline||1.53|-11.39|0.1338
91604575|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|3.566||0.7928|TWO_SIDED|95.0|-7.96|6.08|||Mixed Models Analysis|||Presenteeism Change from Baseline||6.08|-7.96|0.7928
91604576|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.553||0.1366|TWO_SIDED|95.0|-12.3|1.69|||Mixed Models Analysis|||Presenteeism Change from Baseline||1.69|-12.30|0.1366
91604577|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.792||0.076|TWO_SIDED|95.0|-14.21|0.71|||Mixed Models Analysis|||Presenteeism Change from Baseline||0.71|-14.21|0.0760
91651039|NCT00408876|183194549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.802||95.0|-0.91|0.7|||t-test, 2 sided|||||0.70|-0.91|0.802
91604578|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|4.561||0.3602|TWO_SIDED|95.0|-13.16|4.8|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||4.80|-13.16|0.3602
91651040|NCT00408876|183194549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.191||95.0|-0.22|1.11|||t-test, 2 sided|||||1.11|-0.22|0.191
91523375|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.75|||||||Regression, Cox|||change in hemoglobin levels versus change in degree of pain (Week 24)||||0.750
91604579|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|4.516||0.1678|TWO_SIDED|95.0|-15.14|2.65|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||2.65|-15.14|0.1678
91604580|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-11.54|STANDARD_ERROR_OF_MEAN|4.808||0.017|TWO_SIDED|95.0|-21.0|-2.08|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-2.08|-21.00|0.0170
91604581|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|3.174||0.1645|TWO_SIDED|95.0|-10.66|1.82|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.82|-10.66|0.1645
91604582|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.158||0.124|TWO_SIDED|95.0|-11.07|1.34|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.34|-11.07|0.1240
91604583|NCT03952559|183102181|SUPERIORITY||LS Mean difference (Final Values)|-7.02|STANDARD_ERROR_OF_MEAN|3.163||0.027|TWO_SIDED|95.0|-13.23|-0.8|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-0.80|-13.23|0.0270
91604584|NCT03952559|183102182|SUPERIORITY||LS Mean difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.778||0.4778|TWO_SIDED|95.0|-3.49|7.43|||Mixed Models Analysis|||||7.43|-3.49|0.4778
91604585|NCT03952559|183102182|SUPERIORITY||LS Mean difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.743||0.4649|TWO_SIDED|95.0|-3.38|7.39|||Mixed Models Analysis|||||7.39|-3.38|0.4649
91604586|NCT03952559|183102182|SUPERIORITY||LS Mean difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.755||0.1013|TWO_SIDED|95.0|-0.89|9.94|||Mixed Models Analysis|||||9.94|-0.89|0.1013
91604587|NCT03952559|183102183|SUPERIORITY||LS Mean difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.6574|TWO_SIDED|95.0|-0.27|0.42|||Mixed Models Analysis|||||0.42|-0.27|0.6574
91604588|NCT03952559|183102183|SUPERIORITY||LS Mean difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.172||0.9488|TWO_SIDED|95.0|-0.35|0.33|||Mixed Models Analysis|||||0.33|-0.35|0.9488
91604589|NCT03952559|183102183|SUPERIORITY||LS Mean difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4546|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||||0.21|-0.47|0.4546
91604590|NCT03952559|183102184|SUPERIORITY||LS Mean difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8133|TWO_SIDED|95.0|-0.79|0.62|||Mixed Models Analysis|||||0.62|-0.79|0.8133
91604591|NCT03952559|183102184|SUPERIORITY||LS Mean difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.355||0.2517|TWO_SIDED|95.0|-1.11|0.29|||Mixed Models Analysis|||||0.29|-1.11|0.2517
91604592|NCT03952559|183102184|SUPERIORITY||LS Mean difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.0803|TWO_SIDED|95.0|-1.32|0.08|||Mixed Models Analysis|||||0.08|-1.32|0.0803
91604593|NCT01986062|183102192|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91604594|NCT01986062|183102193|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91604595|NCT01986062|183102194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91604596|NCT01986062|183102195|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91604597|NCT01986062|183102196|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91604598|NCT01986062|183102197|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91604599|NCT02587338|183102209|SUPERIORITY|||||||0.74|||||||ANOVA|||||||0.74
91604600|NCT02587338|183102210|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
91604601|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|83.8|||<|0.001|ONE_SIDED|97.5|61.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||61.0|<0.001
91604602|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|88.2|||<|0.001|ONE_SIDED|97.5|67.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||67.4|<0.001
91613703|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.92||||0.55|TWO_SIDED|95.0|0.69|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.||1.22|0.69|0.55
91651041|NCT00408876|183194550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.556||95.0|-1.1|0.59|||t-test, 2 sided|||||0.59|-1.10|0.556
91651042|NCT00408876|183194550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.041||95.0|-1.42|-0.03|||t-test, 2 sided|||||-0.03|-1.42|0.041
91523376|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.936|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 12)||||0.936
91604603|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.999
91604604|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.394|ONE_SIDED|97.5|-410.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-410|0.394
91604605|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|78.4||||0.004|ONE_SIDED|97.5|52.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||52.1|0.004
91604606|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|80.3||||0.002|ONE_SIDED|97.5|54.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||54.7|0.002
91604607|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.992
91604608|NCT00630331|183102225|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.4|ONE_SIDED|97.5|-429.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-429.4|0.400
91651043|NCT00408876|183194550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.22||95.0|-1.14|0.26|||t-test, 2 sided|||||0.26|-1.14|0.220
91651044|NCT00408876|183194550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.278||95.0|-1.33|0.38|||t-test, 2 sided|||||0.38|-1.33|0.278
91651045|NCT00408876|183194550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.673||95.0|-1.04|0.68|||t-test, 2 sided|||||0.68|-1.04|0.673
91651046|NCT00408876|183194550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.422||95.0|-0.42|1.0|||t-test, 2 sided|||||1.00|-0.42|0.422
91651047|NCT00408876|183194551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.234||95.0|-1.03|0.25|||t-test, 2 sided|||||0.25|-1.03|0.234
91651048|NCT00408876|183194551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93|||<|0.001||95.0|-1.46|-0.4|||t-test, 2 sided|||||-0.40|-1.46|<0.001
91651049|NCT00408876|183194551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.213||95.0|-0.87|0.2|||t-test, 2 sided|||||0.20|-0.87|0.213
91651050|NCT00408876|183194551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.105||95.0|-1.19|0.11|||t-test, 2 sided|||||0.11|-1.19|0.105
91651051|NCT00408876|183194551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.876||95.0|-0.6|0.7|||t-test, 2 sided|||||0.70|-0.60|0.876
91651052|NCT00408876|183194551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.033||95.0|0.05|1.13|||t-test, 2 sided|||||1.13|0.05|0.033
91651053|NCT00408876|183194552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.925||95.0|-0.73|0.8|||t-test, 2 sided|||||0.80|-0.73|0.925
91651054|NCT00408876|183194552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.008||95.0|-1.49|-0.22|||t-test, 2 sided|||||-0.22|-1.49|0.008
91651055|NCT00408876|183194552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.132||95.0|-1.12|0.15|||t-test, 2 sided|||||0.15|-1.12|0.132
91651056|NCT00408876|183194552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.024||95.0|-1.67|-0.12|||t-test, 2 sided|||||-0.12|-1.67|0.024
91651057|NCT00408876|183194552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.184||95.0|-1.3|0.25|||t-test, 2 sided|||||0.25|-1.30|0.184
91651058|NCT00408876|183194552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.262||95.0|-0.27|1.01|||t-test, 2 sided|||||1.01|-0.27|0.262
91651059|NCT00408876|183194553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.849||95.0|-0.84|0.69|||t-test, 2 sided|||||0.69|-0.84|0.849
91651060|NCT00408876|183194553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.024||95.0|-1.36|-0.1|||t-test, 2 sided|||||-0.10|-1.36|0.024
91651061|NCT00408876|183194553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.773||95.0|-0.73|0.54|||t-test, 2 sided|||||0.54|-0.73|0.773
91651062|NCT00408876|183194553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.097||95.0|-1.43|0.12|||t-test, 2 sided|||||0.12|-1.43|0.097
91651063|NCT00408876|183194553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.96||95.0|-0.79|0.75|||t-test, 2 sided|||||0.75|-0.79|0.960
91651064|NCT00408876|183194553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.052||95.0|0.0|1.28|||t-test, 2 sided|||||1.28|0.00|0.052
91651065|NCT00408876|183194554|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
91651066|NCT00408876|183194554|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Repeated Measures|||||||0.507
91651067|NCT00408876|183194554|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||Repeated Measures|||||||0.056
91651068|NCT00408876|183194554|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Repeated Measures|||||||0.816
91651069|NCT00408876|183194554|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Repeated Measures|||||||0.208
91651070|NCT00408876|183194554|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Repeated Measures|||||||0.212
91651071|NCT00408876|183194555|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Repeated Measures|||||||0.885
91651072|NCT00408876|183194555|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
91651073|NCT00408876|183194555|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
91651074|NCT00408876|183194555|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Repeated Measures|||||||0.095
91651075|NCT00408876|183194555|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Repeated Measures|||||||0.040
91651076|NCT00408876|183194555|SUPERIORITY_OR_OTHER|||||||0.635||95.0|||||Repeated Measures|||||||0.635
91651077|NCT00408876|183194556|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Repeated Measures|||||||0.575
91651078|NCT00408876|183194556|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Repeated Measures|||||||0.009
91651079|NCT00408876|183194556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
91651080|NCT00408876|183194556|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Repeated Measures|||||||0.115
91604609|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.7||||0.078|ONE_SIDED|97.5|33.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.5|0.078
91604610|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|87.3||||0.104|ONE_SIDED|97.5|4.6|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||4.6|0.104
91604611|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.03|ONE_SIDED|97.5|36.3|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||36.3|0.030
91604612|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|50.0||||0.376|ONE_SIDED|97.5|17.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||17.5|0.376
91604613|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.6||||0.085|ONE_SIDED|97.5|32.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||32.9|0.085
91604614|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.033|ONE_SIDED|97.5|33.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.9|0.033
91604615|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|73.6||||0.265|ONE_SIDED|97.5|-30.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-30.0|0.265
91604616|NCT00630331|183102226|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|51.7||||0.319|ONE_SIDED|97.5|19.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||19.4|0.319
91604617|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|69.5|||<|0.001|ONE_SIDED|97.5|55.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||55.0|<0.001
91604618|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|89.3|||<|0.001|ONE_SIDED|97.5|73.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||73.0|<0.001
91651081|NCT00408876|183194556|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
91651082|NCT00408876|183194556|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Repeated Measures|||||||0.072
91651083|NCT00408876|183194557|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||Repeated Measures|||||||0.516
91651084|NCT00408876|183194557|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
91651085|NCT00408876|183194557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
91604619|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|75.6||||0.04|ONE_SIDED|97.5|35.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||35.1|0.040
91604620|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.9||||0.37|ONE_SIDED|97.5|18.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||18.2|0.37
91604621|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|63.0||||0.003|ONE_SIDED|97.5|46.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||46.7|0.003
91604622|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|81.5|||<|0.001|ONE_SIDED|97.5|60.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||60.9|<0.001
91604623|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.3||||0.53|ONE_SIDED|97.5|-9.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-9.0|0.53
91604624|NCT00630331|183102227|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|53.2||||0.26|ONE_SIDED|97.5|22.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||22.2|0.26
91604625|NCT01302808|183102242|OTHER||Maximum Tolerated Dose|8.0|||||TWO_SIDED|||||||||||||
91604626|NCT02761967|183102254|EQUIVALENCE|The statistical power of the study for the temporal variables was 82%. Multiple linear regression models were obtained for the first and second stages and for the total duration of delivery.||||||0.776|||||||Chi-squared|||||||0.776
91604627|NCT01955707|183102257|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.08|||||TWO_SIDED|90.0|-0.09|0.26||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tissue plasminogen activator (tPA) use.||0.26|-0.09|
91604628|NCT01955707|183102257|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.779|TWO_SIDED|90.0|0.91|1.3||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.30|0.91|0.779
91604629|NCT01955707|183102258|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.09|||||TWO_SIDED|90.0|-0.09|0.27||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.27|-0.09|
91604630|NCT01955707|183102258|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.797|TWO_SIDED|90.0|0.92|1.31||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.31|0.92|0.797
91651086|NCT00408876|183194557|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Repeated Measures|||||||0.112
91651087|NCT00408876|183194557|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Repeated Measures|||||||0.010
91787721|NCT02720107|183455281|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Central memory T cells||||< 0.0001
91523377|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.075|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 24)||||0.075
91604631|NCT01955707|183102259|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.05|||||TWO_SIDED|90.0|-0.13|0.24||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.24|-0.13|
91651088|NCT00408876|183194557|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Repeated Measures|||||||0.219
91787722|NCT02720107|183455281|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Effector memory T cells||||< 0.0001
91523378|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.098|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 12)||||0.098
91787723|NCT02720107|183455281|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||TH17 central memory cells||||< 0.0001
91787724|NCT01949337|183455285|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.33|TWO_SIDED|95.0|0.8|1.08|||Log Rank|||||1.08|0.80|0.33
91604632|NCT01955707|183102259|SUPERIORITY_OR_OTHER||ratio of relative growth|1.05||||0.684|TWO_SIDED|90.0|0.88|1.27||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.27|0.88|0.684
91604633|NCT01955707|183102260|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.0|||||TWO_SIDED|90.0|-0.12|0.11||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.11|-0.12|
91604634|NCT01955707|183102260|SUPERIORITY_OR_OTHER||ratio of relative growth|1.0||||0.487|TWO_SIDED|90.0|0.89|1.12||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.12|0.89|0.487
91604635|NCT01955707|183102261|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.14|0.1||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.10|-0.14|
91604636|NCT01955707|183102261|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.402|TWO_SIDED|90.0|0.87|1.11||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.11|0.87|0.402
91604637|NCT01955707|183102262|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.18|0.13||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to Day 5 using an autoregressive variance-covariance matrix structure. The model adjusts for for treatment, log baseline DWI volume, treatment time window, and tPA use.||0.13|-0.18|
91604638|NCT01955707|183102262|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.394|TWO_SIDED|90.0|0.84|1.14||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.14|0.84|0.394
91604639|NCT01955707|183102263|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.25||||0.427|TWO_SIDED|90.0|-2.48|1.98||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at 24 hours. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||1.98|-2.48|0.427
91604640|NCT01955707|183102263|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.71||||0.896|TWO_SIDED|90.0|-0.52|3.94||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 5. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||3.94|-0.52|0.896
91651089|NCT00408876|183194558|SUPERIORITY_OR_OTHER|||||||0.309||95.0|||||Repeated Measures|||||||0.309
91651090|NCT00408876|183194558|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
91651091|NCT00408876|183194558|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
91651092|NCT00408876|183194558|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Repeated Measures|||||||0.116
91651093|NCT00408876|183194558|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Repeated Measures|||||||0.033
91651094|NCT00408876|183194558|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Repeated Measures|||||||0.480
91651095|NCT00408876|183194559|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Repeated Measures|||||||0.709
91651096|NCT00408876|183194559|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Repeated Measures|||||||0.012
91651097|NCT00408876|183194559|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
91651098|NCT00408876|183194559|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Repeated Measures|||||||0.097
91790891|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.331||0.103|TWO_SIDED|95.0|-1.191|0.109||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.109|-1.191|0.103
91651099|NCT00408876|183194559|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Repeated Measures|||||||0.023
91651100|NCT00408876|183194559|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Repeated Measures|||||||0.435
91651101|NCT00408876|183194560|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||Repeated Measures|||||||0.931
91651102|NCT00408876|183194560|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
91523379|NCT01462162|182922412|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.090
91523380|NCT01462162|182922413|SUPERIORITY_OR_OTHER|||||||0.077|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.077
91651103|NCT00408876|183194560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
91651104|NCT00408876|183194560|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
91651105|NCT00408876|183194560|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
91651106|NCT00408876|183194560|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Repeated Measures|||||||0.416
91651107|NCT00408876|183194561|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||Repeated Measures|||||||0.634
91651108|NCT00408876|183194561|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Repeated Measures|||||||0.031
91651109|NCT00408876|183194561|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
91651110|NCT00408876|183194561|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
91651111|NCT00408876|183194561|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Repeated Measures|||||||0.003
91651112|NCT00408876|183194561|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Repeated Measures|||||||0.313
91651113|NCT00408876|183194562|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Repeated Measures|||||||0.910
91651114|NCT00408876|183194562|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
91651115|NCT00408876|183194562|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
91651116|NCT00408876|183194562|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Repeated Measures|||||||0.090
91651117|NCT00408876|183194562|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
91651118|NCT00408876|183194562|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Repeated Measures|||||||0.171
91651119|NCT00408876|183194563|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||Repeated Measures|||||||0.733
91651120|NCT00408876|183194563|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Repeated Measures|||||||0.022
91651121|NCT00408876|183194563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
91790892|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790893|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.362||0.06|TWO_SIDED|95.0|-1.396|0.028||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.028|-1.396|0.060
91790894|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790895|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.36||0.091|TWO_SIDED|95.0|-1.316|0.098||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.098|-1.316|0.091
91790896|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|3.03|||TWO_SIDED|||||||||Week 72||||
91790897|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.361||0.12|TWO_SIDED|95.0|-1.274|0.147||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.147|-1.274|0.120
91790898|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790899|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.395||0.429|TWO_SIDED|95.0|-1.09|0.464||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.464|-1.090|0.429
91790900|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|3.13|||TWO_SIDED|||||||||Week 96||||
91790901|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.389||0.597|TWO_SIDED|95.0|-0.559|0.97||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.970|-0.559|0.597
91790902|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|2.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91651122|NCT00408876|183194563|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Repeated Measures|||||||0.128
91604641|NCT01955707|183102263|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|3.15||||0.989|TWO_SIDED|90.0|0.89|5.4||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 30. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||5.40|0.89|0.989
91604642|NCT01955707|183102263|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.93||||0.915|TWO_SIDED|90.0|-0.38|4.25||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 90. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||4.25|-0.38|0.915
91604643|NCT01955707|183102264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.564|TWO_SIDED|90.0|0.55|1.45||One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 5. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.45|0.55|0.564
91604644|NCT01955707|183102264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.077|TWO_SIDED|90.0|0.8|2.1||One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 30. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||2.10|0.80|0.077
91604645|NCT01955707|183102264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.243|TWO_SIDED|90.0|0.71|1.86||One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of the distribution of mRS scores at Day 90. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.86|0.71|0.243
91604646|NCT01955707|183102265|SUPERIORITY_OR_OTHER||Adjusted mean|0.68||||0.455|TWO_SIDED|90.0|-9.19|10.56||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 5. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||10.56|-9.19|0.455
91604647|NCT01955707|183102265|SUPERIORITY_OR_OTHER||Adjusted mean|1.21||||0.42|TWO_SIDED|90.0|-8.76|11.19||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 30. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||11.19|-8.76|0.420
91651123|NCT00408876|183194563|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Repeated Measures|||||||0.013
91651124|NCT00408876|183194563|SUPERIORITY_OR_OTHER|||||||0.225||95.0|||||Repeated Measures|||||||0.225
91651125|NCT00408876|183194564|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Repeated Measures|||||||0.890
91651126|NCT00408876|183194564|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Repeated Measures|||||||0.079
91651127|NCT00408876|183194564|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Repeated Measures|||||||0.035
91651128|NCT00408876|183194564|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Repeated Measures|||||||0.117
91523381|NCT01462162|182922413|SUPERIORITY_OR_OTHER|||||||0.961|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.961
91604648|NCT01955707|183102265|SUPERIORITY_OR_OTHER||Adjusted mean|3.56||||0.283|TWO_SIDED|90.0|-6.64|13.75|||repeated measures mixed effects model|||Analysis of Barthel Index at Day 90/Final Visit. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||13.75|-6.64|0.283
91604649|NCT01817790|183102278|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.36||||0.0024|TWO_SIDED|95.0|-0.59|-0.13||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.13|-0.59|0.0024
91604650|NCT01817790|183102279|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.33||||0.0057|TWO_SIDED|95.0|-0.56|-0.1||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.10|-0.56|0.0057
91604651|NCT01817790|183102280|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.41||||0.0009||95.0|-0.65|-0.17||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.17|-0.65|0.0009
91604652|NCT01817790|183102281|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0117|TWO_SIDED|95.0|-0.19|-0.02||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.02|-0.19|0.0117
91604653|NCT01817790|183102282|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.15||||0.0005||95.0|-0.23|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.23|0.0005
91604654|NCT01817790|183102283|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.13||||0.0023||95.0|-0.22|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.22|0.0023
91604655|NCT01817790|183102284|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.18|||<|0.0001||95.0|-0.26|-0.09||p-value was nor adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.09|-0.26|<0.0001
91604656|NCT01817790|183102285|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0304||95.0|-0.18|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.18|0.0304
91604657|NCT01817790|183102286|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0361||95.0|-0.19|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.19|0.0361
91604658|NCT01817790|183102287|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.28||||0.0129|TWO_SIDED|95.0|-0.5|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.50|0.0129
91604659|NCT01817790|183102288|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.14||||0.0002|TWO_SIDED|95.0|-0.22|-0.07||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.07|-0.22|0.0002
91604660|NCT01817790|183102289|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||p-value was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Using this test controlling for investigative site. The response variable lied on ordinal scale of measurement.||Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.||||0.0118
91604661|NCT01817790|183102290|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.01||||0.8586|TWO_SIDED|95.0|-0.12|0.1|||ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.||0.10|-0.12|0.8586
91604662|NCT01817790|183102291|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.29||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.||-0.29|-0.65|<0.0001
91604663|NCT01817790|183102292|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.3||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray||-0.30|-0.68|<0.0001
91651129|NCT00408876|183194564|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Repeated Measures|||||||0.060
91523382|NCT01462162|182922414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91604664|NCT01817790|183102293|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.24||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.24|-0.64|<0.0001
91604665|NCT01817790|183102294|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.33||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.33|-0.73|<0.0001
91604666|NCT01817790|183102295|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.23||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.23|-0.65|<0.0001
91604667|NCT01817790|183102296|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.21||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.21|-0.64|<0.0001
91604668|NCT02847598|183102323|SUPERIORITY||Least squares (LS) mean Difference|-3.4||||0.037|TWO_SIDED|95.0|-6.7|-0.2|||MMRM|||A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.2|-6.7|0.037
91604669|NCT02847598|183102324|SUPERIORITY||LS mean difference|-24.29||||0.015|TWO_SIDED|95.0|-43.7|-4.88|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-4.88|-43.70|0.015
91604670|NCT02847598|183102324|SUPERIORITY||LS mean difference|-33.42|||<|0.001|TWO_SIDED|95.0|-52.71|-14.12|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-14.12|-52.71|<0.001
91604671|NCT02847598|183102324|SUPERIORITY||LS mean difference|-27.99||||0.001|TWO_SIDED|95.0|-44.55|-11.42|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.42|-44.55|0.001
91604672|NCT02847598|183102327|SUPERIORITY||LS Mean Difference|-9.93||||0.22|TWO_SIDED|95.0|-25.94|6.08|||MMRM|||Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||6.08|-25.94|0.220
91604673|NCT02847598|183102327|SUPERIORITY||LS Mean Difference|-8.96||||0.293|TWO_SIDED|95.0|-25.82|7.9|||MMRM|||Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||7.90|-25.82|0.293
91604674|NCT02847598|183102327|SUPERIORITY||LS Mean Difference|-15.74||||0.062|TWO_SIDED|95.0|-32.28|0.79|||MMRM|||Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.79|-32.28|0.062
91604675|NCT02847598|183102328|SUPERIORITY||LS mean difference|-30.36||||0.001|TWO_SIDED|95.0|-48.75|-11.97|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.97|-48.75|0.001
91604676|NCT02847598|183102328|SUPERIORITY||LS mean difference|-37.17|||<|0.001|TWO_SIDED|95.0|-55.46|-18.87|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-18.87|-55.46|<0.001
91604677|NCT02847598|183102328|SUPERIORITY||LS mean difference|-26.05||||0.001|TWO_SIDED|95.0|-41.71|-10.4|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-10.40|-41.71|0.001
91604678|NCT02847598|183102334|SUPERIORITY||LS Mean Difference|-1.7||||0.007|TWO_SIDED|95.0|-3.0|-0.5|||MMRM|||A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.5|-3.0|0.007
91604679|NCT02847598|183102336|SUPERIORITY||LS mean difference|-0.16||||0.667|TWO_SIDED|95.0|-0.9|0.58|||MMRM|||A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.58|-0.90|0.667
91604680|NCT00960076|183102377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.73|-0.31||||||||-0.31|-0.73|
91604681|NCT00960076|183102378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.32|STANDARD_ERROR_OF_MEAN|7.128|||TWO_SIDED|95.0|-37.36|-9.28||||||||-9.28|-37.36|
91604682|NCT00960076|183102379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|STANDARD_ERROR_OF_MEAN|4.409|||TWO_SIDED|95.0|-21.86|-4.5||||||||-4.50|-21.86|
91604683|NCT00960076|183102380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.2||||0.0459|TWO_SIDED|95.0|0.2|22.0|||ANCOVA|||||22.0|0.2|0.0459
91604684|NCT05067127|183102461|SUPERIORITY||Difference in least squares (LS) mean|-1.143|||<|0.0001|TWO_SIDED|95.0|-1.436|-0.85|||MMRM|||An mixed-effect model for repeated measures (MMRM) including fixed categorical effect for treatment group, visit, disease type, baseline immunosuppressants use, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline log-transformed uPCR, was utilized to analyze the log-transformed ratio of uPCR at Week 26 compared to baseline.||-0.85|-1.436|<0.0001
91604685|NCT05067127|183102462|SUPERIORITY||Odds Ratio (OR)|27.516|||<|0.0001|TWO_SIDED|95.0|6.105|124.026|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline eGFR values, baseline log-transformed uPCR values, disease type, and stratification factors.||124.026|6.105|<0.0001
91604686|NCT05067127|183102463|SUPERIORITY||Odds Ratio (OR)|30.932|||<|0.0001|TWO_SIDED|95.0|8.401|113.897|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline log-transformed uPCR values, disease type, and stratification factors.||113.897|8.401|<0.0001
91523383|NCT01462162|182922414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91604687|NCT05067127|183102464|SUPERIORITY||Difference in LS mean|-1.002||||0.2753|TWO_SIDED|95.0|-2.803|0.798|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment as fixed effect, adjusted for baseline C3G histologic index activity score, disease type, and stratification factors.||0.798|-2.803|0.2753
91604688|NCT05067127|183102465|SUPERIORITY||Odds Ratio (OR)|27.392|||<|0.0001|TWO_SIDED|95.0|6.477|115.852|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3c staining, disease type, and stratification factors.||115.852|6.477|<0.0001
91604689|NCT05067127|183102466|SUPERIORITY||Difference in LS mean|6.312||||0.0333|TWO_SIDED|95.0|0.501|12.122|||MMRM|||An MMRM model included fixed categorical effect for treatment group, visit, disease type, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline eGFR, was utilized to analyze the mean change from baseline to Week 26 in eGFR.||12.122|0.501|0.0333
91604690|NCT05067127|183102467|SUPERIORITY||Odds Ratio (OR)|5.753||||0.0006|TWO_SIDED|95.0|2.106|15.716|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline proteinuria values, disease type, and stratification factors.||15.716|2.106|0.0006
91604691|NCT05067127|183102468|SUPERIORITY||Odds Ratio (OR)|88.341||||0.0001|TWO_SIDED|95.0|8.863|880.544|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline albumin values, disease type, and stratification factors.||880.544|8.863|0.0001
91604692|NCT05067127|183102469|SUPERIORITY||Odds Ratio (OR)|999.999||||0.0094|TWO_SIDED|95.0|12.175|9999.999|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3 levels, stratification factors and disease type.||9999.999|12.175|0.0094
91604693|NCT05067127|183102470|SUPERIORITY||Difference in LS mean|0.562||||0.7384|TWO_SIDED|95.0|-2.739|3.863|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||3.863|-2.739|0.7384
91604694|NCT05067127|183102471|SUPERIORITY||Difference in LS mean|1.345||||0.5648|TWO_SIDED|95.0|-3.237|5.927|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||5.927|-3.237|0.5648
91604695|NCT01499173|183102473|SUPERIORITY||||||<|0.01||||||Actual p value shown here; not threshold.|multilevel linear regression|||||||<0.01
91604696|NCT01499173|183102474|SUPERIORITY|||||||0.34|||||||multilevel linear regression|||||||0.34
91604697|NCT01499173|183102475|OTHER|odds ratio|Odds Ratio (OR)|-0.5|||||TWO_SIDED|||||||||Odds ratio was calculated for each question comparing 1 week data with 1 month data||||
91651130|NCT00408876|183194564|SUPERIORITY_OR_OTHER|||||||0.647||95.0|||||Repeated Measures|||||||0.647
91604698|NCT04572633|183102485|OTHER||Wilson Score|95.5|||||TWO_SIDED|95.0|83.72|100.0|||||Bootstrap sampling with replacement method to account for potential within-subject lesion correlations. Subject is the bootstrap sampling unit, 1,000,000 iterations for bootstrap resampling, and the bias-corrected and accelerated method was used.|||100|83.72|
91604699|NCT04572633|183102486|OTHER||Wilson Score|6.8|||||TWO_SIDED|95.0|2.35|18.23||||||||18.23|2.35|
91604700|NCT03155997|183102493|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.00957|TWO_SIDED|95.0|0.598|0.932|||Log Rank|Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.932|0.598|0.00957
91604701|NCT03155997|183102495|SUPERIORITY||Hazard Ratio (HR)|0.717|||||TWO_SIDED|95.0|0.559|0.92|||||Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.920|0.559|
91604702|NCT03304522|183102505|SUPERIORITY||Least Squares (LS) Mean Difference|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.876|-0.293|||Mixed-effects Model for Repeated Measure|||||-0.293|-1.876|<0.0001
91604703|NCT03304522|183102508|SUPERIORITY||LS Mean Difference|-1.111|||<|0.0001|TWO_SIDED|95.0|-1.911|-0.312|||Mixed-effects Model for Repeated Measure|||||-0.312|-1.911|<0.0001
91604704|NCT03304522|183102510|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-1.5|0.3|||Mixed-effects Model for Repeated Measure|||||0.3|-1.5|<0.0001
91604705|NCT00885365|183102518|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is above the non-inferiority margin set at -4.5%.|difference of least square means|-0.5||||0.64|TWO_SIDED|95.0|-2.58|1.59|||ANCOVA|||Based on previous studies, the difference between reference and placebo after 4-week treatment is assumed to be about 12% and the non-inferiority margin safely placed at 4.5%. With a between-patient SD of 13.5% and estimated difference between treatments of zero, sample size of 143 per group allows a 80% power to show the non-inferiority of Bramitob® versus TOBI®. Accounting for an expected dropout rate of 11%, a minimum of 160 participants per group is required.||1.59|-2.58|0.640
91604706|NCT00885365|183102520|SUPERIORITY_OR_OTHER||difference of least square means|-0.01||||0.634|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Analysis for Week 4||0.05|-0.08|0.634
91604707|NCT00885365|183102521|SUPERIORITY_OR_OTHER||difference of least square means|-0.55||||0.63|TWO_SIDED|95.0|-2.78|1.69|||ANCOVA|||Analysis for Week 4||1.69|-2.78|0.630
91604708|NCT00885365|183102522|SUPERIORITY_OR_OTHER||difference of least square means|-0.02||||0.693|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|||Analysis for Week 4||0.06|-0.09|0.693
91604709|NCT00885365|183102523|SUPERIORITY_OR_OTHER||difference of least square means|0.51||||0.777|TWO_SIDED|95.0|-3.06|4.09|||ANCOVA|||Analysis for Week 4||4.09|-3.06|0.777
91604710|NCT00885365|183102524|SUPERIORITY_OR_OTHER||difference of least square means|0.04||||0.505|TWO_SIDED|95.0|-0.08|0.15|||ANCOVA|||Analysis for Week 4||0.15|-0.08|0.505
91604711|NCT00885365|183102525|SUPERIORITY_OR_OTHER||difference of least square means|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.82|TWO_SIDED|95.0|-0.31|0.39||A priori threshold for statistical significance is \<= 0.050.|ANCOVA|treatment and country are fixed effects and baseline log10 bacterial load (CFU/g) value is a covariate||Analysis of Week 4 data||0.39|-0.31|0.820
91604712|NCT00885365|183102528|SUPERIORITY_OR_OTHER|||||||0.692||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 4||||0.692
91604713|NCT00885365|183102528|SUPERIORITY_OR_OTHER|||||||0.128||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 8||||0.128
91604714|NCT00004054|183102535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.76|1.43|||Log Rank|||The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.||1.43|0.76|0.81
91651131|NCT00408876|183194565|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Repeated Measures|||||||0.243
91604715|NCT00004054|183102536|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.82|TWO_SIDED|95.0|0.74|1.27|||Gray's test|2-sided significance level of 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.27|0.74|0.82
91604716|NCT00004054|183102537|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.09|TWO_SIDED|95.0|0.28|1.1|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.10|0.28|0.09
91604717|NCT00004054|183102538|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.42|TWO_SIDED|95.0|0.48|1.36|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.36|0.48|0.42
91604718|NCT00004054|183102539|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.61|TWO_SIDED|95.0|0.75|1.19|||Log Rank|2-sided significance level = 0.05|Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.19|0.75|0.61
91604719|NCT01756456|183102549|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|35.3|||<|0.001|TWO_SIDED|97.06|15.88|54.71|||Chi-squared|||Phase II||54.71|15.88|<0.001
91604720|NCT01756456|183102549|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|38.4|||=|0.001|TWO_SIDED|97.06|18.96|57.83|||Chi-squared|||||57.83|18.96|=0.001
91604721|NCT01756456|183102550|SUPERIORITY||Difference in percentage|25.8|||=|0.016|TWO_SIDED|97.06|3.66|47.87|||Chi-squared|||||47.87|3.66|=0.016
91604722|NCT01756456|183102550|SUPERIORITY||Difference in percentage|34.7|||=|0.002|TWO_SIDED|97.06|11.91|57.41|||Chi-squared|||||57.41|11.91|=0.002
91604723|NCT01756456|183102551|SUPERIORITY||difference in percentage|2.4|||=|0.818|TWO_SIDED|97.06|-20.3|25.08|||Chi-squared|||At week 6 - reading center||25.08|-20.30|=0.818
91604724|NCT01756456|183102551|SUPERIORITY||difference in percentage|-6.3|||=|0.571|TWO_SIDED|97.06|-30.62|17.96|||Chi-squared|||at week 6 - central reading center||17.96|-30.62|=0.571
91523384|NCT01462162|182922415|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91604725|NCT01756456|183102551|SUPERIORITY||Difference in percentage|20.3|||=|0.064|TWO_SIDED|97.06|-3.11|43.79|||Chi-squared|||week 6 - investigator||43.79|-3.11|=0.064
91604726|NCT01756456|183102551|SUPERIORITY||Difference in percentage|23.1|||=|0.041|TWO_SIDED|97.06|-0.89|47.04|||Chi-squared|||week 6 - investigator||47.04|-0.89|=0.041
91604727|NCT01756456|183102551|SUPERIORITY||Difference in percentage|21.9|||=|0.031|TWO_SIDED|97.06|0.07|43.64|||Chi-squared|||week 8 - central reading center||43.64|0.07|=0.031
91604728|NCT01756456|183102551|SUPERIORITY||difference in percentage|26.9|||=|0.008|TWO_SIDED|97.06|5.57|48.28|||Chi-squared|||week 8 - central reading center||48.28|5.57|=0.008
91604729|NCT01756456|183102551|SUPERIORITY||Difference in percentage|26.1|||=|0.011|TWO_SIDED|97.06|4.18|48.01|||Chi-squared|||week 8 - investigator||48.01|4.18|=0.011
91604730|NCT01756456|183102551|SUPERIORITY||Difference in percentage|25.9|||=|0.014|TWO_SIDED|97.06|3.55|48.33|||Chi-squared|||week 8 - investigator||48.33|3.55|=0.014
91604731|NCT01756456|183102552|SUPERIORITY||difference in percentage|13.7|||=|0.065|TWO_SIDED|95.0|-0.19|27.57|||Chi-squared|||week 4||27.57|-0.19|=0.065
91604732|NCT01756456|183102552|SUPERIORITY||difference in percentage|12.4|||=|0.097|TWO_SIDED|95.0|-2.05|26.78|||Chi-squared|||week 4||26.78|-2.05|=0.097
91604733|NCT01756456|183102552|SUPERIORITY||difference in percentage|16.9|||=|0.036|TWO_SIDED|95.0|1.97|31.92|||Chi-squared|||week 6||31.92|1.97|=0.036
91604734|NCT01756456|183102552|SUPERIORITY||difference in percentage|15.6|||=|0.054|TWO_SIDED|95.0|0.04|31.12|||Chi-squared|||week 6||31.12|0.04|=0.054
91604735|NCT01756456|183102552|SUPERIORITY||difference in percentage|17.1|||=|0.043|TWO_SIDED|95.0|1.45|32.72|||Chi-squared|||week 8||32.72|1.45|=0.043
91604736|NCT01756456|183102552|SUPERIORITY||difference in percentage|11.4|||=|0.157|TWO_SIDED|95.0|-4.08|26.93|||Chi-squared|||week 8||26.93|-4.08|=0.157
91604737|NCT01756456|183102553|SUPERIORITY||least square mean difference|8.9|||=|0.022|TWO_SIDED|95.0|1.33|16.5|||ANCOVA|||||16.50|1.33|=0.022
91604738|NCT01756456|183102553|SUPERIORITY||least square mean difference|5.0|||=|0.213|TWO_SIDED|95.0|-2.9|12.88|||ANCOVA|||||12.88|-2.90|=0.213
91604739|NCT01756456|183102554|SUPERIORITY||difference in percentage|5.5|||=|0.592|TWO_SIDED|95.0|-14.53|25.48|||Chi-squared|||week 4||25.48|-14.53|=0.592
91604740|NCT01756456|183102554|SUPERIORITY|week 4|difference in percentage|-2.3|||=|0.835|TWO_SIDED|95.0|-24.01|19.4|||Chi-squared|||||19.40|-24.01|=0.835
91604741|NCT01756456|183102554|SUPERIORITY||difference in percentage|27.7|||=|0.008|TWO_SIDED|95.0|8.1|47.22|||Chi-squared|||week 6||47.22|8.10|=0.008
91604742|NCT01756456|183102554|SUPERIORITY||difference in percentage|12.4|||=|0.282|TWO_SIDED|95.0|-9.91|34.68|||Chi-squared|||week 6||34.68|-9.91|=0.282
91604743|NCT01756456|183102554|SUPERIORITY||difference in percentage|10.2|||=|0.303|TWO_SIDED|95.0|-9.15|29.45|||Chi-squared|||||29.45|-9.15|=0.303
91604744|NCT01756456|183102554|SUPERIORITY||difference in percentage|7.9|||=|0.442|TWO_SIDED|95.0|-12.13|27.92|||Chi-squared|||week 8||27.92|-12.13|=0.442
91604745|NCT01756456|183102555|SUPERIORITY||difference in percentage|-2.6|||=|0.597|TWO_SIDED|95.0|-22.87|17.71|||Chi-squared|||week 4||17.71|-22.87|=0.597
91651132|NCT00408876|183194565|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Repeated Measures|||||||0.110
91604746|NCT01756456|183102555|SUPERIORITY||difference in percentage|-2.3|||>|0.999|TWO_SIDED|95.0|-23.26|18.71|||Chi-squared|||week 4||18.71|-23.26|>0.999
91604747|NCT01756456|183102555|SUPERIORITY||difference in percentage|-7.8|||=|0.183|TWO_SIDED|95.0|-28.7|13.76|||Chi-squared|||week 6||13.76|-28.70|=0.183
91604748|NCT01756456|183102555|SUPERIORITY||difference in percentage|-10.0|||=|0.116|TWO_SIDED|95.0|-31.41|11.88|||Chi-squared|||week 6||11.88|-31.41|=0.116
91604749|NCT01756456|183102555|SUPERIORITY||difference in percentage|-10.8|||=|0.134|TWO_SIDED|95.0|-31.3|10.35|||Chi-squared|||week 8||10.35|-31.30|=0.134
91604750|NCT01756456|183102555|SUPERIORITY||difference in percentage|-7.9|||=|0.307|TWO_SIDED|95.0|-29.51|13.52|||Chi-squared|||week 8||13.52|-29.51|=0.307
91604751|NCT01756456|183102557|SUPERIORITY||Odds Ratio (OR)|2.18|||=|0.041|TWO_SIDED|95.0|1.03|4.62|||Chi-squared|||week 4||4.62|1.03|=0.041
91604752|NCT01756456|183102557|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.081|TWO_SIDED|95.0|0.92|4.11|||Chi-squared|||week 4||4.11|0.92|=0.081
91604753|NCT01756456|183102557|SUPERIORITY||Odds Ratio (OR)|2.47|||=|0.04|TWO_SIDED|95.0|1.04|5.88|||Chi-squared|||week 8||5.88|1.04|=0.040
91604754|NCT01756456|183102557|SUPERIORITY||Odds Ratio (OR)|1.93|||=|0.132|TWO_SIDED|95.0|0.82|4.52|||Chi-squared|||week 8||4.52|0.82|=0.132
91604755|NCT01756456|183102562|SUPERIORITY||difference in percentage|15.8|||=|0.097|TWO_SIDED|95.0|-2.36|33.97|||Chi-squared|||week 4||33.97|-2.36|=0.097
91604756|NCT01756456|183102562|SUPERIORITY||difference in percentage|13.2|||=|0.175|TWO_SIDED|95.0|-5.72|32.15|||Chi-squared|||week 4||32.15|-5.72|=0.175
91604757|NCT01756456|183102562|SUPERIORITY||difference in percentage|16.9|||=|0.105|TWO_SIDED|95.0|-3.11|37.0|||Chi-squared|||week 6||37.00|-3.11|=0.105
91523385|NCT01462162|182922415|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91523386|NCT01462162|182922416|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91523387|NCT01462162|182922416|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91604758|NCT01756456|183102562|SUPERIORITY||difference in percentage|11.0|||=|0.3|TWO_SIDED|95.0|-9.64|31.57|||Chi-squared|||week 6||31.57|-9.64|=0.300
91604759|NCT01756456|183102562|SUPERIORITY||difference in percentage|27.5|||=|0.008|TWO_SIDED|95.0|8.33|46.67|||Chi-squared|||week 8||46.67|8.33|=0.008
91604760|NCT01756456|183102562|SUPERIORITY||difference in percentage|19.0|||=|0.068|TWO_SIDED|95.0|-0.91|38.83|||Chi-squared|||week 8||38.83|-0.91|=0.068
91604761|NCT00813995|183102563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparison|ANCOVA|||||||<.001
91604762|NCT02507349|183102568|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Time-by-treatment interaction||||<0.0001
91604763|NCT02507349|183102568|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49.||||0.0033
91604764|NCT02507349|183102568|SUPERIORITY|||||||0.3164|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.3164
91604765|NCT02507349|183102568|SUPERIORITY|||||||0.0482|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.0482
91604766|NCT02507349|183102568|SUPERIORITY|||||||0.9928|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.9928
91604767|NCT02507349|183102569|SUPERIORITY|||||||0.6243|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.6243
91604768|NCT02507349|183102569|SUPERIORITY|||||||0.1969|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.1969
91790903|NCT02880956|183460086|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.86|TWO_SIDED|95.0|-0.717|0.858||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.858|-0.717|0.860
91604769|NCT02507349|183102569|SUPERIORITY|||||||0.0042|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49||||0.0042
91604770|NCT02507349|183102569|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.0002
91604771|NCT02507349|183102569|SUPERIORITY|||||||0.7254|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.7254
91604772|NCT02507349|183102569|SUPERIORITY|||||||0.058|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.0580
91604773|NCT02507349|183102570|SUPERIORITY|||||||0.4677|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.4677
91604774|NCT02507349|183102570|SUPERIORITY|||||||0.094|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0940
91604775|NCT02507349|183102571|SUPERIORITY|||||||0.8733|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.8733
91604776|NCT02507349|183102571|SUPERIORITY|||||||0.0113|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0113
91604777|NCT02507349|183102572|SUPERIORITY|||||||0.2328|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.2328
91604778|NCT02507349|183102572|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0005
91604779|NCT02507349|183102573|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0033
91604780|NCT02507349|183102574|SUPERIORITY|||||||0.1649|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.1649
91604781|NCT02507349|183102574|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0016
91604782|NCT02507349|183102575|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0080
91604783|NCT02507349|183102576|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91604784|NCT02507349|183102577|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
91604785|NCT03094195|183102611|SUPERIORITY||least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.689|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.9|-1.3|0.689
91604786|NCT03094195|183102611|SUPERIORITY||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.54||0.35|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.6|-1.6|0.350
91604787|NCT03094195|183102615|SUPERIORITY||Odds Ratio (OR)|0.9||||0.908|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.908
91790904|NCT02880956|183460086|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790905|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.497||0.854|TWO_SIDED|95.0|-1.069|0.885||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.885|-1.069|0.854
91790906|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790907|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.491||0.412|TWO_SIDED|95.0|-1.368|0.562||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.562|-1.368|0.412
91790908|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790909|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.503||0.262|TWO_SIDED|95.0|-1.554|0.424||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.424|-1.554|0.262
91790910|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790911|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.571||0.11|TWO_SIDED|95.0|-0.209|2.036||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.036|-0.209|0.110
91790912|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91604788|NCT03094195|183102615|SUPERIORITY||Odds Ratio (OR)|1.4||||0.609|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.609
91604789|NCT03094195|183102616|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.800
91604790|NCT03094195|183102616|SUPERIORITY||Odds Ratio (OR)|1.4||||0.653|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.653
91651133|NCT00408876|183194565|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Repeated Measures|||||||0.236
91651134|NCT00408876|183194565|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Repeated Measures|||||||0.014
91651135|NCT00408876|183194565|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
91651136|NCT00408876|183194565|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
91651137|NCT00408876|183194566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.465||95.0|-0.84|0.39|||t-test, 2 sided|||||0.39|-0.84|0.465
91651138|NCT00408876|183194566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79||||0.002||95.0|-1.3|-0.29|||t-test, 2 sided|||||-0.29|-1.30|0.002
91651139|NCT00408876|183194566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.233||95.0|-0.82|0.2|||t-test, 2 sided|||||0.20|-0.82|0.233
91651140|NCT00408876|183194566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.075||95.0|-1.19|0.06|||t-test, 2 sided|||||0.06|-1.19|0.075
91651141|NCT00408876|183194566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.798||95.0|-0.71|0.54|||t-test, 2 sided|||||0.54|-0.71|0.798
91651142|NCT00408876|183194566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.066||95.0|-0.03|1.0|||t-test, 2 sided|||||1.00|-0.03|0.066
91651143|NCT00408876|183194567|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||Fisher Exact|||||||0.869
91651144|NCT00408876|183194567|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Fisher Exact|||||||0.141
91651145|NCT00408876|183194567|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||||||0.033
91651146|NCT00408876|183194567|SUPERIORITY_OR_OTHER|||||||0.142||95.0|||||Fisher Exact|||||||0.142
91651147|NCT00408876|183194567|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Fisher Exact|||||||0.049
91651148|NCT00408876|183194567|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Fisher Exact|||||||0.587
91651149|NCT00408876|183194568|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||Fisher Exact|||||||0.356
91651150|NCT00408876|183194568|SUPERIORITY_OR_OTHER|||||||0.472||95.0|||||Fisher Exact|||||||0.472
91651151|NCT00408876|183194568|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
91651152|NCT00408876|183194568|SUPERIORITY_OR_OTHER|||||||0.107||95.0|||||Fisher Exact|||||||0.107
91651153|NCT00408876|183194568|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||Fisher Exact|||||||0.053
91651154|NCT00408876|183194568|SUPERIORITY_OR_OTHER|||||||0.779||95.0|||||Fisher Exact|||||||0.779
91604791|NCT03094195|183102618|SUPERIORITY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.49||0.225|TWO_SIDED|95.0|-0.4|1.6|||ANCOVA|||||1.6|-0.4|0.225
91604792|NCT03094195|183102618|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.53||0.914|TWO_SIDED|95.0|-1.0|1.1|||ANCOVA|||||1.1|-1.0|0.914
91651155|NCT00408876|183194569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.747||95.0|-1.47|1.06|||t-test, 2 sided|||||1.06|-1.47|0.747
91651156|NCT00408876|183194569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.045||95.0|-2.12|-0.02|||t-test, 2 sided|||||-0.02|-2.12|0.045
91651157|NCT00408876|183194569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.58||95.0|-0.76|1.36|||t-test, 2 sided|||||1.36|-0.76|0.580
91651158|NCT00408876|183194569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86||||0.185||95.0|-2.14|0.41|||t-test, 2 sided|||||0.41|-2.14|0.185
91651159|NCT00408876|183194569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.438||95.0|-0.77|1.79|||t-test, 2 sided|||||1.79|-0.77|0.438
91651160|NCT00408876|183194569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.012||95.0|0.3|2.44|||t-test, 2 sided|||||2.44|0.30|0.012
91651161|NCT00408876|183194570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46||||0.729||95.0|-2.16|3.08|||t-test, 2 sided|||||3.08|-2.16|0.729
91651162|NCT00408876|183194570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.352||95.0|-1.14|3.18|||t-test, 2 sided|||||3.18|-1.14|0.352
91651163|NCT00408876|183194570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.465||95.0|-3.0|1.37|||t-test, 2 sided|||||1.37|-3.00|0.465
91651164|NCT00408876|183194570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.677||95.0|-2.09|3.21|||t-test, 2 sided|||||3.21|-2.09|0.677
91651165|NCT00408876|183194570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.345||95.0|-3.92|1.38|||t-test, 2 sided|||||1.38|-3.92|0.345
91651166|NCT00408876|183194570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.102||95.0|-4.04|0.37|||t-test, 2 sided|||||0.37|-4.04|0.102
91651167|NCT00408876|183194571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.977||95.0|-2.91|2.83|||t-test, 2 sided|||||2.83|-2.91|0.977
91651168|NCT00408876|183194571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.451||95.0|-1.44|3.24|||t-test, 2 sided|||||3.24|-1.44|0.451
91604793|NCT01651780|183102622|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.77||||0.2692|TWO_SIDED|95.0|0.48|1.23|||Chi-squared|||||1.23|0.48|0.2692
91604794|NCT01651780|183102623|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.89||||0.4967|TWO_SIDED|95.0|0.64|1.24|||Chi-squared|||||1.24|0.64|0.4967
91604795|NCT03359902|183102747|SUPERIORITY||beta|1.4||||0.11|TWO_SIDED||||||Mixed Models Analysis|||"A linear mixed effects model was conducted to account for carryover and order effects in this crossover trial.~Assuming α = 0.05, two-sided test, and 60 participants in total. If the carryover effect is negligible, we will have 90% power to detect an effect size of 0.604 for memory improvement"||||0.11
91651169|NCT00408876|183194571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.15||95.0|-0.63|4.11|||t-test, 2 sided|||||4.11|-0.63|0.150
91651170|NCT00408876|183194571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.524||95.0|-1.96|3.83|||t-test, 2 sided|||||3.83|-1.96|0.524
91651171|NCT00408876|183194571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78||||0.23||95.0|-1.13|4.69|||t-test, 2 sided|||||4.69|-1.13|0.230
91523388|NCT01462162|182922417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91523389|NCT01462162|182922417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91651172|NCT00408876|183194571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.491||95.0|-1.55|3.23|||t-test, 2 sided|||||3.23|-1.55|0.491
91651173|NCT00408876|183194572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.645||95.0|-0.49|0.79|||t-test, 2 sided|||||0.79|-0.49|0.645
91651174|NCT00408876|183194572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.027||95.0|0.07|1.12|||t-test, 2 sided|||||1.12|0.07|0.027
91651175|NCT00408876|183194572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.006||95.0|0.22|1.29|||t-test, 2 sided|||||1.29|0.22|0.006
91651176|NCT00408876|183194572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.18||95.0|-0.21|1.1|||t-test, 2 sided|||||1.10|-0.21|0.180
91651177|NCT00408876|183194572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.069||95.0|-0.05|1.25|||t-test, 2 sided|||||1.25|-0.05|0.069
91651178|NCT00408876|183194572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.564||95.0|-0.38|0.7|||t-test, 2 sided|||||0.70|-0.38|0.564
91651179|NCT00408876|183194573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.929||95.0|-0.92|1.0|||t-test, 2 sided|||||1.00|-0.92|0.929
91787725|NCT03595618|183455325|SUPERIORITY||Adjusted mean difference|0.04514|STANDARD_ERROR_OF_MEAN|0.02465||0.165|TWO_SIDED|95.0|-0.00317|0.09345||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value||0.09345|-0.00317|0.165
91790913|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.555||0.263|TWO_SIDED|95.0|-1.713|0.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.469|-1.713|0.263
91651180|NCT00408876|183194573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.147||95.0|-0.21|1.36|||t-test, 2 sided|||||1.36|-0.21|0.147
91651181|NCT00408876|183194573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.7||95.0|-0.64|0.95|||t-test, 2 sided|||||0.95|-0.64|0.700
91651182|NCT00408876|183194573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.279||95.0|-0.44|1.51|||t-test, 2 sided|||||1.51|-0.44|0.279
91651183|NCT00408876|183194573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.822||95.0|-0.86|1.09|||t-test, 2 sided|||||1.09|-0.86|0.822
91651184|NCT00408876|183194573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.299||95.0|-1.22|0.38|||t-test, 2 sided|||||0.38|-1.22|0.299
91651185|NCT00408876|183194574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.766||95.0|-1.33|0.98|||t-test, 2 sided|||||0.98|-1.33|0.766
91651186|NCT00408876|183194574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.217||95.0|-0.35|1.55|||t-test, 2 sided|||||1.55|-0.35|0.217
91523390|NCT01462162|182922418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91651187|NCT00408876|183194574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.88||95.0|-0.89|1.04|||t-test, 2 sided|||||1.04|-0.89|0.880
91651188|NCT00408876|183194574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.193||95.0|-0.39|1.94|||t-test, 2 sided|||||1.94|-0.39|0.193
91651189|NCT00408876|183194574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.675||95.0|-0.92|1.42|||t-test, 2 sided|||||1.42|-0.92|0.675
91651190|NCT00408876|183194574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.288||95.0|-1.5|0.45|||t-test, 2 sided|||||0.45|-1.50|0.288
91651191|NCT00408876|183194575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.501||95.0|-1.66|0.81|||t-test, 2 sided|||||0.81|-1.66|0.501
91651192|NCT00408876|183194575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.524||95.0|-0.69|1.35|||t-test, 2 sided|||||1.35|-0.69|0.524
91651193|NCT00408876|183194575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.089||95.0|-0.14|1.91|||t-test, 2 sided|||||1.91|-0.14|0.089
91651194|NCT00408876|183194575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.234||95.0|-0.49|2.0|||t-test, 2 sided|||||2.00|-0.49|0.234
91651195|NCT00408876|183194575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.04||95.0|0.06|2.56|||t-test, 2 sided|||||2.56|0.06|0.040
91651196|NCT00408876|183194575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.289||95.0|-0.48|1.59|||t-test, 2 sided|||||1.59|-0.48|0.289
91651197|NCT00408876|183194576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.862||95.0|-0.27|0.32|||t-test, 2 sided|||||0.32|-0.27|0.862
91651198|NCT00408876|183194576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.368||95.0|-0.13|0.35|||t-test, 2 sided|||||0.35|-0.13|0.368
91651199|NCT00408876|183194576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.628||95.0|-0.18|0.31|||t-test, 2 sided|||||0.31|-0.18|0.628
91651200|NCT00408876|183194576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.573||95.0|-0.21|0.38|||t-test, 2 sided|||||0.38|-0.21|0.573
91651201|NCT00408876|183194576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.819||95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.819
91651202|NCT00408876|183194576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.687||95.0|-0.3|0.2|||t-test, 2 sided|||||0.20|-0.30|0.687
91651203|NCT00408876|183194577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.972||95.0|-0.48|0.5|||t-test, 2 sided|||||0.50|-0.48|0.972
91651204|NCT00408876|183194577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.99||95.0|-0.4|0.4|||t-test, 2 sided|||||0.40|-0.40|0.990
91651205|NCT00408876|183194577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.793||95.0|-0.35|0.46|||t-test, 2 sided|||||0.46|-0.35|0.793
91651206|NCT00408876|183194577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.981||95.0|-0.5|0.49|||t-test, 2 sided|||||0.49|-0.50|0.981
91651207|NCT00408876|183194577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.857||95.0|-0.45|0.54|||t-test, 2 sided|||||0.54|-0.45|0.857
91651208|NCT00408876|183194577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.805||95.0|-0.36|0.46|||t-test, 2 sided|||||0.46|-0.36|0.805
91651209|NCT00408876|183194578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.34||95.0|-0.26|0.75|||t-test, 2 sided|||||0.75|-0.26|0.340
91790914|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91787726|NCT03595618|183455325|SUPERIORITY||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.02585||0.939|TWO_SIDED|95.0|-0.03868|0.06267||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.06267|-0.03868|0.939
91787727|NCT03595618|183455325|SUPERIORITY||Adjusted mean difference|0.02329|STANDARD_ERROR_OF_MEAN|0.02536||0.682|TWO_SIDED|95.0|-0.02641|0.073|||Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.07300|-0.02641|0.682
91523391|NCT01462162|182922418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91604796|NCT01795547|183102750|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was \> -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D \> -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was \>0.|Least Squares Mean Difference|4.666||||0.036|TWO_SIDED|95.0|0.316|9.015|||Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.||9.015|0.316|0.036
91604797|NCT01795547|183102751|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.492||||0.043|TWO_SIDED|95.0|-2.935|-0.049||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.049|-2.935|0.043
91604798|NCT01795547|183102752|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.283||||0.004|TWO_SIDED|95.0|-0.477|-0.09||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.090|-0.477|0.004
91604799|NCT01795547|183102753|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.331||||0.149|TWO_SIDED|95.0|-0.12|0.782||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.782|-0.120|0.149
91604800|NCT01795547|183102754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.753||||0.039|TWO_SIDED|95.0|0.093|3.412||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.412|0.093|0.039
91604801|NCT01795547|183102755|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.764||||0.07|TWO_SIDED|95.0|-0.143|3.672||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.672|-0.143|0.070
91604802|NCT01795547|183102756|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.922||||0.13|TWO_SIDED|95.0|-0.275|2.119||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||2.119|-0.275|0.130
91604803|NCT01795547|183102757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.007||||0.561|TWO_SIDED|95.0|-2.402|4.417||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||4.417|-2.402|0.561
91604804|NCT01795547|183102758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.695||||0.095|TWO_SIDED|95.0|-1.511|0.121||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.121|-1.511|0.095
91604805|NCT00642642|183102760|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||a priori threshold for statistical significance was 0.05|McNemar|Paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||0.0109
91604806|NCT00642642|183102761|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||a priori threshold for statistical significance = 0.05|McNemar|paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||<0.0001
91604807|NCT02116621|183102764|SUPERIORITY||Adjusted difference in differences|-1.36|||||TWO_SIDED|95.0|-2.91|0.19|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.19|-2.91|
91604808|NCT02116621|183102765|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)|||0.21
91604809|NCT02116621|183102766|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)|||0.06
91604810|NCT02116621|183102767|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)|||0.35
91651210|NCT00408876|183194578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.848||95.0|-0.45|0.37|||t-test, 2 sided|||||0.37|-0.45|0.848
91651211|NCT00408876|183194578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.573||95.0|-0.54|0.3|||t-test, 2 sided|||||0.30|-0.54|0.573
91651212|NCT00408876|183194578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.272||95.0|-0.79|0.22|||t-test, 2 sided|||||0.22|-0.79|0.272
91523392|NCT01462162|182922419|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91604811|NCT02116621|183102768|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)|||0.86
91604812|NCT02116621|183102769|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).|||0.70
91604813|NCT02116621|183102770|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).|||0.20
91604814|NCT02116621|183102771|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).|||0.66
91604815|NCT02116621|183102772|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).|||0.44
91604816|NCT02116621|183102773|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).|||0.58
91604817|NCT02116621|183102774|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).|||0.73
91604818|NCT02116621|183102775|SUPERIORITY||Adjusted difference in differences|-1.41|||||TWO_SIDED|95.0|-2.87|0.06|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.06|-2.87|
91604819|NCT02116621|183102776|SUPERIORITY||Adjusted difference in differences|0.93|||||TWO_SIDED|95.0|-0.92|2.79|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|2.79|-0.92|
91604820|NCT02116621|183102777|SUPERIORITY||Adjusted difference in differences|-0.17|||||TWO_SIDED|95.0|-1.45|1.12|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|1.12|-1.45|
91604821|NCT02116621|183102778|SUPERIORITY||Adjusted difference in differences|1.9|||||TWO_SIDED|95.0|-1.66|5.47|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|5.47|-1.66|
91604822|NCT02116621|183102779|SUPERIORITY||Adjusted difference in differences|4.64|||||TWO_SIDED|95.0|-2.25|11.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|11.54|-2.25|
91651213|NCT00408876|183194578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.161||95.0|-0.88|0.15|||t-test, 2 sided|||||0.15|-0.88|0.161
91604823|NCT02116621|183102780|SUPERIORITY||Adjusted difference in differences|2.55|||||TWO_SIDED|95.0|-1.5|6.6|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|6.60|-1.50|
91604824|NCT02116621|183102781|SUPERIORITY||Adjusted difference in differences|7.29|||||TWO_SIDED|95.0|-3.16|17.75|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|17.75|-3.16|
91523393|NCT01462162|182922419|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91651214|NCT00408876|183194578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.711||95.0|-0.5|0.34|||t-test, 2 sided|||||0.34|-0.50|0.711
91523394|NCT01462162|182922420|SUPERIORITY_OR_OTHER|||||||0.172|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.172
91651215|NCT00408876|183194579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.713||95.0|-1.39|0.95|||t-test, 2 sided|||||0.95|-1.39|0.713
91523395|NCT01462162|182922420|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Logistic|||Baseline for Week 24 versus Week 24||||<0.05
91523396|NCT01462162|182922421|SUPERIORITY_OR_OTHER|||||||0.162|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.162
91523397|NCT01462162|182922421|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 24||||<0.001
91523398|NCT01462162|182922422|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91604825|NCT02116621|183102782|SUPERIORITY||Adjusted difference in differences|3.31|||||TWO_SIDED|95.0|-1.57|8.19|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|8.19|-1.57|
91651216|NCT00408876|183194579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.288||95.0|-0.44|1.49|||t-test, 2 sided|||||1.49|-0.44|0.288
91604826|NCT02116621|183102783|SUPERIORITY||Adjusted difference in differences|-1.57|||||TWO_SIDED|95.0|-7.68|4.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|4.54|-7.68|
91651217|NCT00408876|183194579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.351||95.0|-1.44|0.51|||t-test, 2 sided|||||0.51|-1.44|0.351
91604827|NCT02116621|183102784|SUPERIORITY||Mean Difference (Final Values)|11.9||||0.01|TWO_SIDED|95.0|2.59|21.24|||Regression, Linear|||||21.24|2.59|0.01
91604828|NCT02116621|183102785|SUPERIORITY||Adjusted difference in differences|-0.79|||||TWO_SIDED|95.0|-2.37|0.8|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||0.80|-2.37|
91604829|NCT02116621|183102786|SUPERIORITY||Adjusted difference in differences|0.31|||||TWO_SIDED|95.0|-1.18|1.81|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.81|-1.18|
91604830|NCT02116621|183102787|SUPERIORITY||Adjusted difference in differences|0.3|||||TWO_SIDED|95.0|-1.01|1.61|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.61|-1.01|
91604831|NCT02116621|183102788|SUPERIORITY||Adjusted difference in differences|-0.66|||||TWO_SIDED|95.0|-2.55|1.24|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.24|-2.55|
91604832|NCT02116621|183102789|SUPERIORITY||Adjusted difference in differences|1.05|||||TWO_SIDED|95.0|-2.54|4.64|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||4.64|-2.54|
91604833|NCT02116621|183102790|SUPERIORITY||Adjusted difference in differences|4.24|||||TWO_SIDED|95.0|-2.73|11.2|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||11.20|-2.73|
91604834|NCT02116621|183102791|SUPERIORITY||Adjusted difference in differences|1.76|||||TWO_SIDED|95.0|-2.37|5.89|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||5.89|-2.37|
91604835|NCT02116621|183102792|SUPERIORITY||Adjusted difference in differences|7.77|||||TWO_SIDED|95.0|-2.87|18.42|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||18.42|-2.87|
91604836|NCT02116621|183102793|SUPERIORITY||Adjusted difference in differences|2.15|||||TWO_SIDED|95.0|-2.84|7.13|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||7.13|-2.84|
91604837|NCT02116621|183102794|SUPERIORITY||Adjusted difference in differences|1.81|||||TWO_SIDED|95.0|-4.41|8.02|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||8.02|-4.41|
91604838|NCT02116621|183102795|SUPERIORITY||Adjusted difference in differences|0.16|||||TWO_SIDED|95.0|-1.47|1.79|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.79|-1.47|
91604839|NCT02116621|183102796|SUPERIORITY||Adjusted difference in differences|-1.24|||||TWO_SIDED|95.0|-2.77|0.3|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||0.30|-2.77|
91604840|NCT02116621|183102797|SUPERIORITY||Adjusted difference in differences|-0.26|||||TWO_SIDED|95.0|-1.61|1.09|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.09|-1.61|
91604841|NCT02116621|183102798|SUPERIORITY||Adjusted difference in differences|0.76|||||TWO_SIDED|95.0|-1.19|2.7|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||2.70|-1.19|
91651218|NCT00408876|183194579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.219||95.0|-0.44|1.93|||t-test, 2 sided|||||1.93|-0.44|0.219
91604842|NCT02116621|183102799|SUPERIORITY||Adjusted difference in differences|0.08|||||TWO_SIDED|95.0|-3.61|3.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||3.77|-3.61|
91651219|NCT00408876|183194579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.686||95.0|-1.43|0.94|||t-test, 2 sided|||||0.94|-1.43|0.686
91604843|NCT02116621|183102800|SUPERIORITY||Adjusted difference in differences|-1.91|||||TWO_SIDED|95.0|-9.07|5.26|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.26|-9.07|
91604844|NCT02116621|183102801|SUPERIORITY||Adjusted difference in differences|1.53|||||TWO_SIDED|95.0|-2.7|5.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.77|-2.70|
91604845|NCT02116621|183102802|SUPERIORITY||Adjusted difference in differences|4.13|||||TWO_SIDED|95.0|-6.81|15.07|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||15.07|-6.81|
91604846|NCT02116621|183102803|SUPERIORITY||Adjusted difference in differences|1.0|||||TWO_SIDED|95.0|-4.11|6.11|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||6.11|-4.11|
91604847|NCT02116621|183102804|SUPERIORITY||Adjusted difference in differences|1.11|||||TWO_SIDED|95.0|-5.27|7.48|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||7.48|-5.27|
91604848|NCT02116621|183102805|SUPERIORITY||Mean Difference (Final Values)|9.41||||0.054|TWO_SIDED|95.0|-0.15|18.96|||Regression, Linear|||||18.96|-0.15|0.054
91604849|NCT00151892|183102806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.|Difference in proportions|0.02||||||95.0|-0.04|0.08||||||The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.||0.08|-0.04|
91604850|NCT04672083|183102848|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
91604851|NCT04672083|183102849|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
91604852|NCT04672083|183102850|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% confidence interval for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
91604853|NCT04672083|183102851|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
91604854|NCT04672083|183102852|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
91604855|NCT04672083|183102853|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
91604856|NCT04672083|183102854|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
91651220|NCT00408876|183194579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98||||0.05||95.0|-1.97|0.0|||t-test, 2 sided|||||0.00|-1.97|0.050
91651221|NCT00408876|183194580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.663||95.0|-0.06|0.04|||t-test, 2 sided|||||0.04|-0.06|0.663
91651222|NCT00408876|183194580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.33||95.0|-0.02|0.06|||t-test, 2 sided|||||0.06|-0.02|0.330
91651223|NCT00408876|183194580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.143||95.0|-0.01|0.07|||t-test, 2 sided|||||0.07|-0.01|0.143
91523399|NCT01462162|182922422|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
91523400|NCT01462162|182922423|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91651224|NCT00408876|183194580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.218||95.0|-0.02|0.08|||t-test, 2 sided|||||0.08|-0.02|0.218
91651225|NCT00408876|183194580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.1||95.0|-0.01|0.09|||t-test, 2 sided|||||0.09|-0.01|0.100
91604857|NCT04672083|183102855|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantification.||||<0.05
91604858|NCT04672083|183102856|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
91604859|NCT04672083|183102857|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
91604860|NCT04672083|183102858|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
91604861|NCT02764541|183102869|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive ductal carcinoma||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||||||0.0045
91604862|NCT02764541|183102869|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive lobular carcinoma||||||0.0161|||||||Wilcoxon (Mann-Whitney)|||||||0.0161
91604863|NCT02764541|183102870|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D||||||0.9288|||||||Wilcoxon (Mann-Whitney)|||||||0.9288
91604864|NCT02764541|183102872|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D|Mean Difference (Final Values)|0.02||||0.92|TWO_SIDED|95.0|-0.29|0.32|||Regression, Linear|||||0.32|-0.29|0.920
91604865|NCT02764541|183102873|EQUIVALENCE|The hypothesis is that there is no difference of RCB response rate between Arm C and Arm D||||||0.758|||||||Fisher Exact|||||||0.758
91604866|NCT00749190|183102884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0226|TWO_SIDED|95.0|-0.44|-0.03||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 1 mg minus placebo|||-0.03|-0.44|0.0226
91604867|NCT00749190|183102884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.59|-0.18||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 5 mg minus placebo|||-0.18|-0.59|0.0002
91604868|NCT00749190|183102884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.51||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 10 mg minus placebo|||-0.51|-0.91|<0.0001
91604869|NCT00749190|183102884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.5||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 25 mg minus placebo|||-0.50|-0.91|<0.0001
91604870|NCT00749190|183102884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.84|-0.43||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 50 mg minus placebo|||-0.43|-0.84|<0.0001
91604871|NCT03726268|183102929|OTHER|||||||0.97|||||||Negative binomial regression|||||||0.970
91604872|NCT03726268|183102929|OTHER|||||||0.631|||||||Negative binomial regression|||||||0.631
91523401|NCT01462162|182922423|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
91651226|NCT00408876|183194580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.614||95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.614
91651227|NCT00408876|183194581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.786||95.0|-1.83|1.39|||t-test, 2 sided|||||1.39|-1.83|0.786
91604873|NCT03726268|183102930|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91604874|NCT03726268|183102930|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91604875|NCT03726268|183102931|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91604876|NCT03726268|183102931|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91604877|NCT03726268|183102932|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91604878|NCT03726268|183102932|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91604879|NCT03726268|183102933|OTHER|||||||0.105|||||||Negative binomial regression|||||||0.105
91604880|NCT03726268|183102933|OTHER|||||||0.531|||||||Negative binomial regression|||||||0.531
91604881|NCT00490542|183102934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.6|10.2||||||||10.2|0.6|
91604882|NCT03136107|183102953|EQUIVALENCE|Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF||||||||||||||||CI % values (which is the percentage that half the 95 % CI represents of the mean values).|Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.|||
91651228|NCT00408876|183194581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.445||95.0|-1.85|0.81|||t-test, 2 sided|||||0.81|-1.85|0.445
91604883|NCT01707992|183102958|SUPERIORITY||Hazard Ratio (HR)|0.937|||=|0.7057|TWO_SIDED|95.0|0.668|1.313||Threshold for significance at 0.05 level.|Cox proportional hazards model|||The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to \[\<=\] 4 or greater than \[\>\] 4), country/geographical region (CGR), categorical age at baseline (\<=38 or \>38), and T2 volume at baseline were included as covariates in the model.||1.313|0.668|= 0.7057
91651229|NCT00408876|183194581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.39||||0.043||95.0|0.04|2.74|||t-test, 2 sided|||||2.74|0.04|0.043
91604884|NCT04167345|183102973|SUPERIORITY||Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.1|2.3|||t-test, 2 sided|||||2.3|1.1|<.0001
91604885|NCT04167345|183102973|SUPERIORITY||Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.9|||t-test, 2 sided|||||2.9|1.1|<.0001
91604886|NCT04167345|183102975|SUPERIORITY||Mean Difference|2.0||||0.0114|TWO_SIDED|95.0|0.5|3.4|||t-test, 2 sided|||||3.4|0.5|0.0114
91604887|NCT04167345|183102975|SUPERIORITY||Mean Difference|2.3||||0.0009|TWO_SIDED|95.0|1.1|3.5|||t-test, 2 sided|||||3.5|1.1|0.0009
91604888|NCT03797001|183102992|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
91604889|NCT00824564|183103020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.5|STANDARD_ERROR_OF_MEAN|58.63||0.348|TWO_SIDED|95.0|-172.7|61.7|||t-test, 2 sided|||The mean difference with associated standard error (SE), and corresponding 95% confidence interval (CI) for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||61.7|-172.7|0.348
91651230|NCT00408876|183194581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.721||95.0|-1.92|1.33|||t-test, 2 sided|||||1.33|-1.92|0.721
91604890|NCT00824564|183103021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.0|STANDARD_ERROR_OF_MEAN|32.78||0.466|TWO_SIDED|95.0|-41.3|89.3|||t-test, 2 sided|||The mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||89.3|-41.3|0.466
91604891|NCT00824564|183103022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.57||0.109|TWO_SIDED|95.0|-20.7|2.2|||t-test, 2 sided|||For 1 hour post-surgery, the mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||2.2|-20.7|0.109
91651231|NCT00408876|183194581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.053||95.0|-0.02|3.24|||t-test, 2 sided|||||3.24|-0.02|0.053
91523402|NCT01462162|182922424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
91523403|NCT01462162|182922424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
91523404|NCT03485911|182922428|SUPERIORITY||negative binomial regression model|30.0||||0.024|TWO_SIDED|95.0|4.6|48.7|||negative binomial regression model|||||48.7|4.6|0.024
91651232|NCT00408876|183194581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.91||||0.006||95.0|0.54|3.27|||t-test, 2 sided|||||3.27|0.54|0.006
91651233|NCT00408876|183194582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.378||95.0|-0.48|1.25|||t-test, 2 sided|||||1.25|-0.48|0.378
91604892|NCT00824564|183103022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.24||0.045|TWO_SIDED|95.0|-13.4|-0.1|||t-test, 2 sided|||For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||-0.1|-13.4|0.045
91651234|NCT00408876|183194582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.723||95.0|-0.84|0.59|||t-test, 2 sided|||||0.59|-0.84|0.723
91651235|NCT00408876|183194582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.542||95.0|-0.95|0.5|||t-test, 2 sided|||||0.50|-0.95|0.542
91651236|NCT00408876|183194582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.245||95.0|-1.39|0.36|||t-test, 2 sided|||||0.36|-1.39|0.245
91651237|NCT00408876|183194582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.169||95.0|-1.48|0.26|||t-test, 2 sided|||||0.26|-1.48|0.169
91651238|NCT00408876|183194582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.796||95.0|-0.82|0.63|||t-test, 2 sided|||||0.63|-0.82|0.796
91604893|NCT00824564|183103022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|4.2||0.119|TWO_SIDED|95.0|-15.4|1.8|||t-test, 2 sided|||For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||1.8|-15.4|0.119
91523405|NCT03485911|182922428|SUPERIORITY||negative binomial regression model|44.2|||<|0.001|TWO_SIDED|95.0|23.0|59.5|||negative binomial regression model|||||59.5|23.0|<0.001
91604894|NCT00824564|183103022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|15.16||0.139|TWO_SIDED|95.0|-52.9|7.5|||t-test, 2 sided|||For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||7.5|-52.9|0.139
91604895|NCT00824564|183103023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|STANDARD_ERROR_OF_MEAN|132.1||0.849|TWO_SIDED|95.0|-238.2|288.6|||t-test, 2 sided|||The mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||288.6|-238.2|0.849
91604896|NCT00824564|183103024|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||Chi-square test was used at 5% level of significance.||||0.714
91651239|NCT00408876|183194584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91651240|NCT00408876|183194584|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
91523406|NCT03485911|182922430|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.453|TWO_SIDED|95.0|-10.08|4.53|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||4.53|-10.08|0.453
91523407|NCT03485911|182922430|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.188|TWO_SIDED|95.0|-12.23|2.43|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||2.43|-12.23|0.188
91651241|NCT00408876|183194584|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
91651242|NCT00408876|183194585|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
91651243|NCT00408876|183194586|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 2 sided|||||||0.048
91651244|NCT00408876|183194587|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
91651245|NCT00408876|183194587|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|||||||0.046
91604897|NCT00824564|183103025|SUPERIORITY_OR_OTHER||Least square means difference|0.37|STANDARD_ERROR_OF_MEAN|0.295||0.208|TWO_SIDED|95.0|-0.21|0.96|||Mixed Models Analysis|||For change at end of surgery, a Mixed Model Repeated Measures (MMRM) approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.96|-0.21|0.208
91604898|NCT00824564|183103025|SUPERIORITY_OR_OTHER||Least square means difference|0.1|STANDARD_ERROR_OF_MEAN|0.255||0.682|TWO_SIDED|95.0|-0.4|0.61|||Mixed Models Analysis|||For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.61|-0.40|0.682
91604899|NCT00824564|183103025|SUPERIORITY_OR_OTHER||Least square means difference|0.14|STANDARD_ERROR_OF_MEAN|0.244||0.569|TWO_SIDED|95.0|-0.35|0.63|||Mixed Models Analysis|||For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.63|-0.35|0.569
91651246|NCT00408876|183194588|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
91651247|NCT00408876|183194589|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
91651248|NCT00408876|183194590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91604900|NCT00824564|183103025|SUPERIORITY_OR_OTHER||Least square means difference|0.2|STANDARD_ERROR_OF_MEAN|0.249||0.413|TWO_SIDED|95.0|-0.29|0.7|||Mixed Models Analysis|||For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.70|-0.29|0.413
91651249|NCT00408876|183194591|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|||||||0.031
91651250|NCT00408876|183194592|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||||||0.030
91651251|NCT00408876|183194593|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
91651252|NCT00408876|183194593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91651253|NCT00408876|183194593|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
91651254|NCT00408876|183194594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.38||||0.348||95.0|-4.28|1.51|||t-test, 2 sided|||||1.51|-4.28|0.348
91651255|NCT00408876|183194594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.04||95.0|0.11|4.89|||t-test, 2 sided|||||4.89|0.11|0.040
91651256|NCT00408876|183194594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.191||95.0|-0.81|4.03|||t-test, 2 sided|||||4.03|-0.81|0.191
91651257|NCT00408876|183194594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.89||||0.009||95.0|0.97|6.8|||t-test, 2 sided|||||6.80|0.97|0.009
91651258|NCT00408876|183194594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0||||0.044||95.0|0.08|5.91|||t-test, 2 sided|||||5.91|0.08|0.044
91651259|NCT00408876|183194594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.473||95.0|-3.33|1.55|||t-test, 2 sided|||||1.55|-3.33|0.473
91651260|NCT00408876|183194595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.846||95.0|-3.61|4.4|||t-test, 2 sided|||||4.40|-3.61|0.846
91651261|NCT00408876|183194595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.934||95.0|-3.45|3.17|||t-test, 2 sided|||||3.17|-3.45|0.934
91651262|NCT00408876|183194595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.03||||0.234||95.0|-1.32|5.39|||t-test, 2 sided|||||5.39|-1.32|0.234
91651263|NCT00408876|183194595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.794||95.0|-4.58|3.5|||t-test, 2 sided|||||3.50|-4.58|0.794
91604901|NCT00824564|183103025|SUPERIORITY_OR_OTHER||Least square means difference|0.11|STANDARD_ERROR_OF_MEAN|0.276||0.686|TWO_SIDED|95.0|-0.44|0.66|||Mixed Models Analysis|||For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.66|-0.44|0.686
91604902|NCT00824564|183103026|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||Fisher Exact|||Fisher's exact test at 5% level of significance was used as the event rate was low and the expected count for any cell in the (unstratified) 2\*2 contingency table was less than 5.||||0.241
91604903|NCT03804671|183103027|OTHER|Absolute bioavailability. The statistical model was an ANOVA on the logarithmic scale including the fixed effect for 'formulation' and 'subject' as a random effect.|Ratio of the geometric means (T/R) %|70.32|||||TWO_SIDED|90.0|56.69|87.23|||||The geometric coefficient of variation (gCV) = 18.7. Ratio was calculated as (AUC0-∞/dose) oral /(AUC0-∞/dose) intravenous multiplied by 100.|||87.23|56.69|
91604904|NCT01552057|183103029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0988|TWO_SIDED|95.0|-0.7|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||0.06|-0.70|0.0988
91604905|NCT01552057|183103030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0003|TWO_SIDED|95.0|-0.76|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.22|-0.76|0.0003
91604906|NCT01552057|183103031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0012|TWO_SIDED|95.0|-0.71|-0.18||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.18|-0.71|0.0012
91604907|NCT01552057|183103032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.35||||0.0073|TWO_SIDED|95.0|-9.26|-1.45||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.45|-9.26|0.0073
91604908|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.34||||0.0049|TWO_SIDED|95.0|1.32|7.35||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Physical Functioning||7.35|1.32|0.0049
91604909|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.76||||0.0003|TWO_SIDED|95.0|3.57|11.94||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Physical||11.94|3.57|0.0003
91604910|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.67||||0.0002|TWO_SIDED|95.0|2.76|8.59||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Bodily Pain||8.59|2.76|0.0002
91604911|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25||||0.0192|TWO_SIDED|95.0|0.53|5.96||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||General Health||5.96|0.53|0.0192
91604912|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7||||0.0002|TWO_SIDED|95.0|3.15|10.25||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Vitality||10.25|3.15|0.0002
91604913|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.04||||0.0014|TWO_SIDED|95.0|2.74|11.34||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Social Functioning||11.34|2.74|0.0014
91604914|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12||||0.0002|TWO_SIDED|95.0|4.41|13.83||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Emotional||13.83|4.41|0.0002
91604915|NCT01552057|183103033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.91|||<|0.0001|TWO_SIDED|95.0|4.39|11.43||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Mental Health||11.43|4.39|<0.0001
91604916|NCT01552057|183103034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.85||||0.0002|TWO_SIDED|95.0|-4.32|-1.38||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.38|-4.32|0.0002
91604917|NCT01552057|183103035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0029|TWO_SIDED|95.0|-2.12|-0.44||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||WPI||-0.44|-2.12|0.0029
91604918|NCT01552057|183103035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0906|TWO_SIDED|95.0|-0.79|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Symptom Severity||0.06|-0.79|0.0906
91604919|NCT01552057|183103036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0755|TWO_SIDED|95.0|-0.7|0.03||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Pain||0.03|-0.70|0.0755
91604920|NCT01552057|183103036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0232|TWO_SIDED|95.0|-0.88|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.06|-0.88|0.0232
91604921|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0126|TWO_SIDED|95.0|-0.99|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.12|-0.99|0.0126
91604922|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0092|TWO_SIDED|95.0|-0.87|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Least Pain||-0.12|-0.87|0.0092
91604923|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0083|TWO_SIDED|95.0|-1.0|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Pain Right Now||-0.15|-1.00|0.0083
91651264|NCT00408876|183194595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.64||||0.426||95.0|-2.4|5.67|||t-test, 2 sided|||||5.67|-2.40|0.426
91709557|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-9.6|-0.9||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.9|-9.6|
91651265|NCT00408876|183194595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.207||95.0|-1.21|5.55|||t-test, 2 sided|||||5.55|-1.21|0.207
91651266|NCT00408876|183194596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.901||95.0|-2.54|2.89|||t-test, 2 sided|||||2.89|-2.54|0.901
91651267|NCT00408876|183194596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.926||95.0|-2.35|2.14|||t-test, 2 sided|||||2.14|-2.35|0.926
91651268|NCT00408876|183194596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62||||0.002||95.0|1.35|5.9|||t-test, 2 sided|||||5.90|1.35|0.002
91651269|NCT00408876|183194596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.841||95.0|-3.02|2.46|||t-test, 2 sided|||||2.46|-3.02|0.841
91651270|NCT00408876|183194596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.45||||0.014||95.0|0.71|6.19|||t-test, 2 sided|||||6.19|0.71|0.014
91651271|NCT00408876|183194596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73||||0.001||95.0|1.44|6.02|||t-test, 2 sided|||||6.02|1.44|0.001
91651272|NCT00408876|183194597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.057||95.0|-1.41|0.02|||t-test, 2 sided|||||0.02|-1.41|0.057
91651273|NCT00408876|183194597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.128||95.0|-1.05|0.13|||t-test, 2 sided|||||0.13|-1.05|0.128
91651274|NCT00408876|183194597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82||||0.007||95.0|-1.42|-0.22|||t-test, 2 sided|||||-0.22|-1.42|0.007
91651275|NCT00408876|183194597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.518||95.0|-0.48|0.96|||t-test, 2 sided|||||0.96|-0.48|0.518
91651276|NCT00408876|183194597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.734||95.0|-0.85|0.6|||t-test, 2 sided|||||0.60|-0.85|0.734
91651277|NCT00408876|183194597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.239||95.0|-0.97|0.24|||t-test, 2 sided|||||0.24|-0.97|0.239
91651278|NCT00291330|183194598|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.05|||<|0.0001||95.0|0.65|1.7||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.70|0.65|<0.0001
91651279|NCT00291330|183194598|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates|Risk Difference (Percentage)|0.4|||<|0.0001||95.0|-0.8|1.5||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.50|-0.80|<0.0001
91651280|NCT00291330|183194598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.65|1.84|||Regression, Cox|Patients without events are censored at day 180||Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.84|0.65|
91651281|NCT00291330|183194599|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.622||95.0|-1.0|1.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.70|-1.00|0.6220
91651282|NCT00291330|183194599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9844||95.0|0.69|1.46|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.69|0.9844
91651283|NCT00291330|183194600|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.2||||0.6466||95.0|-1.1|0.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.70|-1.10|0.6466
91709558|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.1|||||TWO_SIDED|95.0|-13.0|-4.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-4.0|-13.0|
91651284|NCT00291330|183194600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.385||95.0|0.4|1.42|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.42|0.40|0.3850
91651285|NCT00291330|183194601|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.2981||95.0|-0.3|1.0|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.00|-0.30|0.2981
91651286|NCT00291330|183194601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.1092||95.0|0.86|4.68|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||4.68|0.86|0.1092
91651287|NCT00291330|183194602|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.5327||95.0|-1.2|0.6|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.60|-1.20|0.5327
91651288|NCT00291330|183194602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.3332||95.0|0.03|3.15|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.15|0.03|0.3332
91651289|NCT00291330|183194603|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.1||||0.8018||95.0|-1.0|0.8|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.80|-1.00|0.8018
91651290|NCT00291330|183194603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8203||95.0|0.54|1.63|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.63|0.54|0.8203
91651291|NCT00291330|183194604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.5063||95.0|0.45|1.48|||Regression, Cox|||Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.48|0.45|0.5063
91651292|NCT00291330|183194604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Regression, Cox|||Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.85|0.59|0.0002
91651293|NCT00566709|183194607|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91651294|NCT00566709|183194608|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
91651295|NCT00566709|183194609|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared, Corrected|||||||0.56
91651296|NCT00566709|183194610|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
91651297|NCT00566709|183194611|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Chi-squared, Corrected|||||||0.77
91651298|NCT00566709|183194612|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||||||0.22
91651299|NCT03443869|183194613|NON_INFERIORITY|LET was concluded non-inferior to VGCV if the upper bound of the two-sided 95% CI for difference in percentage of participants with adjudicated CMV disease (LET - VGCV) was no higher than 10%|Stratum-adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-6.5|3.8|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||3.8|-6.5|
91604924|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0807|TWO_SIDED|95.0|-0.98|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With General Activity||0.06|-0.98|0.0807
91604925|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0057|TWO_SIDED|95.0|-1.29|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Mood||-0.22|-1.29|0.0057
91604926|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.1114|TWO_SIDED|95.0|-0.84|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Walking Ability||0.09|-0.84|0.1114
91604927|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1081|TWO_SIDED|95.0|-0.94|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Normal Work||0.09|-0.94|0.1081
91604928|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0264|TWO_SIDED|95.0|-1.04|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Relationships With Other People||-0.07|-1.04|0.0264
91604929|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.3959|TWO_SIDED|95.0|-0.81|0.32||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Sleep||0.32|-0.81|0.3959
91604930|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0119|TWO_SIDED|95.0|-1.18|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Enjoyment of Life||-0.15|-1.18|0.0119
91604931|NCT01552057|183103037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0222|TWO_SIDED|95.0|-0.96|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Interference||-0.07|-0.96|0.0222
91604932|NCT01552057|183103038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0113|TWO_SIDED|95.0|-0.71|-0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.09|-0.71|0.0113
91604933|NCT01552057|183103039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.0005|TWO_SIDED|95.0|-0.94|-0.27||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.27|-0.94|0.0005
91604934|NCT01552057|183103040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.37||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.37|-1.07|<0.0001
91604935|NCT01552057|183103041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0226|TWO_SIDED|95.0|-0.82|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.06|-0.82|0.0226
91604936|NCT01552057|183103042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0408|TWO_SIDED|95.0|-0.74|-0.02||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||||-0.02|-0.74|0.0408
91604937|NCT03895203|183103046|SUPERIORITY||Odds Ratio (OR)|7.082|||<|0.001|TWO_SIDED|95.0|4.583|10.943|||Regression, Logistic|||||10.943|4.583|<0.001
91787728|NCT03595618|183455326|SUPERIORITY||Odds Ratio (OR)|1.47|STANDARD_ERROR_OF_MEAN|0.29||0.396|TWO_SIDED|95.0|0.84|2.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||2.58|0.84|0.396
91604938|NCT03895203|183103047|SUPERIORITY||Least square (LS) mean difference|-0.187|||<|0.001|TWO_SIDED|95.0|-0.249|-0.125|||ANCOVA|||||-0.125|-0.249|<0.001
91604939|NCT03895203|183103049|SUPERIORITY||Odds Ratio (OR)|63.039|||<|0.001|TWO_SIDED|95.0|22.211|178.918|||Regression, Logistic|||||178.918|22.211|<0.001
91604940|NCT03895203|183103050|SUPERIORITY||LS mean difference|4.337|||<|0.001|TWO_SIDED|95.0|3.229|5.444|||ANCOVA|||||5.444|3.229|<0.001
91604941|NCT03895203|183103051|SUPERIORITY||Odds Ratio (OR)|5.447|||<|0.001|TWO_SIDED|95.0|3.668|8.088|||Regression, Logistic|||||8.088|3.668|<0.001
91604942|NCT03895203|183103052|SUPERIORITY||LS mean difference|-0.327||||0.001|TWO_SIDED|95.0|-0.524|-0.13|||ANOVA|||||-0.130|-0.524|0.001
91604943|NCT03895203|183103053|SUPERIORITY||Odds Ratio (OR)|1.904||||0.008|TWO_SIDED|95.0|1.18|3.074|||Regression, Logistic|||||3.074|1.180|0.008
91604944|NCT03895203|183103054|SUPERIORITY||Odds Ratio (OR)|3.437||||0.002|TWO_SIDED|95.0|1.559|7.574|||Regression, Logistic|||||7.574|1.559|0.002
91604945|NCT03895203|183103056|SUPERIORITY||LS mean difference|-0.281||||0.001|TWO_SIDED|95.0|-0.452|-0.111|||ANCOVA|||||-0.111|-0.452|0.001
91604946|NCT00473876|183103216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.08||95.0|||||t-test, 1 sided|The differences between baseline and post-intervention (4 months) was analyzed using independent t-test, comparing metformin and placebo.||Null hypothesis: Metformin has no effect on peak VO2. We targetted 66 subjects and power calculation based on our previous observational study of CHF with insulin resistance with mean peak VO2 of 11.||||0.08
91604947|NCT00473876|183103217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.45|STANDARD_DEVIATION|10.72||0.034||95.0|||||t-test, 1 sided|Compare between metformin and placebo arm.||Null hypothesis: Metformin has no effect on the ratio between VCO2 (production of CO2) and VE (ventilation), it is also called the VE/VCO2 slope||||0.034
91604948|NCT04373460|183103250|SUPERIORITY||Risk Difference (RD)|3.4||||0.005|TWO_SIDED|95.0|1.0|5.8|||Fisher Exact|||||5.8|1.0|0.005
91604949|NCT04373460|183103251|SUPERIORITY||Risk Difference (RD)|-0.05||||0.16|TWO_SIDED|95.0|-0.11|0.02|||Rate per person-years|||||0.02|-0.11|0.16
91604950|NCT04373460|183103252|SUPERIORITY||Incidence rate difference|0.18||||0.02|TWO_SIDED|95.0|0.03|0.32|||Rate per person-years|||||0.32|0.03|0.02
91604951|NCT04373460|183103253|SUPERIORITY||Risk Difference (RD)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.02|||Rate per person-years|||||0.02|-0.01|0.32
91604952|NCT04373460|183103258|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
91604953|NCT04373460|183103262|SUPERIORITY||Risk Ratio (RR)|0.525|||||TWO_SIDED|95.0|0.192|1.425||||||||1.425|0.192|
91604954|NCT01272583|183103263|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||1.0
91604955|NCT01272583|183103264|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||GLP-1 intact|ANOVA|The Friedman Test was used for ANOVA||||||<0.001
91604956|NCT01272583|183103264|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||GLP-1 Total|ANOVA|The Friedman Test was used for ANOVA.||||||0.98
91604957|NCT01272583|183103264|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||GIP intact|ANOVA|The Friedman Test was used for ANOVA.||||||0.049
91604958|NCT01272583|183103264|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||GIP total|ANOVA|The Friedman Test was used for ANOVA||||||0.44
91604959|NCT01272583|183103265|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.14
91604960|NCT01272583|183103266|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.98
91604961|NCT01272583|183103267|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.22
91604962|NCT01272583|183103268|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.01
91604963|NCT01272583|183103268|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Dunn's Multiple Comparison Test|Post Hoc testing||||||<0.05
91604964|NCT01272583|183103269|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.76
91604965|NCT03498521|183103280|SUPERIORITY||Stratified Cox proportional hazard|0.75||||0.0177|TWO_SIDED|95.0|0.59|0.95|||Stratified log-rank|||||0.95|0.59|0.0177
91604966|NCT02848833|183103308|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
91604967|NCT02848833|183103311|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
91604968|NCT02848833|183103312|OTHER|Difference before administration versus after administration was analyzed using a paired t-test.|||||<|0.0001|||||||paired t-test|||||||<0.0001
91604969|NCT02848833|183103313|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
91604970|NCT02848833|183103314|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
91604971|NCT03464045|183103362|OTHER||Hazard Ratio (HR)|0.8||||0.122|TWO_SIDED|95.0|0.61|1.06|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.06|0.61|0.122
91604972|NCT03464045|183103362|OTHER||Hazard Ratio (HR)|0.89||||0.417|TWO_SIDED|95.0|0.67|1.18|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.18|0.67|0.417
91709559|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.6|||||TWO_SIDED|95.0|-14.0|-3.7||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-3.7|-14.0|
91787729|NCT03595618|183455326|SUPERIORITY||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.26||0.951|TWO_SIDED|95.0|0.53|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.50|0.53|0.951
91604973|NCT03464045|183103362|OTHER||Hazard Ratio (HR)|0.88||||0.376|TWO_SIDED|95.0|0.66|1.17|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.17|0.66|0.376
91604974|NCT03464045|183103363|OTHER||Hazard Ratio (HR)|0.79||||0.22|TWO_SIDED|95.0|0.55|1.15|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.15|0.55|0.220
91604975|NCT03464045|183103363|OTHER||Hazard Ratio (HR)|0.91||||0.628|TWO_SIDED|95.0|0.63|1.32|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.32|0.63|0.628
91604976|NCT03464045|183103363|OTHER||Hazard Ratio (HR)|0.91||||0.632|TWO_SIDED|95.0|0.63|1.33|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.33|0.63|0.632
91604977|NCT03464045|183103364|OTHER||Hazard Ratio (HR)|0.84||||0.42|TWO_SIDED|95.0|0.54|1.29|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.29|0.54|0.420
91604978|NCT03464045|183103364|OTHER||Hazard Ratio (HR)|0.89||||0.606|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.38|0.57|0.606
91604979|NCT03464045|183103364|OTHER||Hazard Ratio (HR)|0.89||||0.609|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.38|0.57|0.609
91604980|NCT03878147|183103369|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.82|<|0.01|TWO_SIDED|95.0|0.78|4.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||4.01|0.78|<.01
91604981|NCT03878147|183103369|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.82||0.32|TWO_SIDED|95.0|-0.8|2.44||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||2.44|-0.80|.32
91651300|NCT03443869|183194614|OTHER||Stratum-adjusted Treatment Difference|-1.7|||||TWO_SIDED|95.0|-3.4|0.1|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||0.1|-3.4|
91651301|NCT03443869|183194616|OTHER||Difference in Percentages|-0.1|||||TWO_SIDED|95.0|-4.4|4.2|||||Difference = LET minus VGCV|||4.2|-4.4|
91651302|NCT03443869|183194617|OTHER||Difference in Percentages|-3.7|||||TWO_SIDED|95.0|-7.0|-0.9|||||Difference = LET minus VGCV|||-0.9|-7.0|
91651303|NCT00931385|183194637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.183|0.113|<0.0001
91651304|NCT00931385|183194637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.113|<0.0001
91651305|NCT00931385|183194637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.106|0.177|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.177|0.106|<0.0001
91709560|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-3.2|||||TWO_SIDED|95.0|-6.8|-0.3||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.3|-6.8|
91709561|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.4|0.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.4|-6.4|
91709562|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.4|2.4||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.4|-4.4|
91651306|NCT00931385|183194638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.146|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.146|0.073|<0.0001
91651307|NCT00931385|183194638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.164|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.164|0.091|<0.0001
91651308|NCT00931385|183194638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.209|0.135|<0.0001
91651309|NCT00931385|183194639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.094|0.163|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.163|0.094|<0.0001
91651310|NCT00931385|183194639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.103|0.172|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.172|0.103|<0.0001
91651311|NCT00931385|183194639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.122|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.122|<0.0001
91651312|NCT00931385|183194640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.201|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.201|0.126|<0.0001
91651313|NCT00931385|183194640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.127|0.202|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.202|0.127|<0.0001
91651314|NCT00931385|183194640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.16|0.236|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.236|0.160|<0.0001
91709563|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
91709564|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.1|
91604982|NCT03878147|183103369|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.99||0.07|TWO_SIDED|95.0|-3.74|0.16||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.16|-3.74|.07
91787730|NCT03595618|183455326|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.27||0.985|TWO_SIDED|95.0|0.64|1.83||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.83|0.64|0.985
91604983|NCT03878147|183103369|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.96||0.83|TWO_SIDED|95.0|-2.1|1.68||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||1.68|-2.10|.83
91604984|NCT03878147|183103370|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.65|TWO_SIDED|95.0|-0.71|0.42||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.42|-0.71|.65
91604985|NCT03878147|183103370|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.29||0.95|TWO_SIDED|95.0|-0.54|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.54|.95
91604986|NCT03878147|183103370|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.34|TWO_SIDED|95.0|-0.92|0.13||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.13|-0.92|.34
91604987|NCT03878147|183103370|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.33||0.81|TWO_SIDED|95.0|-0.73|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.73|.81
91651315|NCT00931385|183194641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.135|0.214|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.214|0.135|<0.0001
91651316|NCT00931385|183194641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.127|0.206|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.206|0.127|<0.0001
91651317|NCT00931385|183194641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.257|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.257|0.178|<0.0001
91651318|NCT00931385|183194642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.064|0.147|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.064|<0.0001
91651319|NCT00931385|183194642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.072|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.072|<0.0001
91604988|NCT03878147|183103371|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|0.004|0.043||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.043|0.004|.01
91604989|NCT03878147|183103371|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|0.003|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.040|0.003|.02
91604990|NCT03878147|183103371|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.05||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.05|-0.01|.19
91604991|NCT03878147|183103371|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.04|-0.01|.19
91604992|NCT05424276|183103413|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|1.895||0.686|TWO_SIDED|95.0|-4.522|2.985||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo from baseline to 12 weeks of treatment||2.985|-4.522|0.686
91604993|NCT05424276|183103413|SUPERIORITY||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|1.876||0.606|TWO_SIDED|95.0|-2.745|4.687||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo from baseline to 12 weeks of treatment||4.687|-2.745|0.606
91604994|NCT05424276|183103413|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|1.925||0.509|TWO_SIDED|95.0|-2.539|5.086||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo from baseline to 12 weeks of treatment||5.086|-2.539|0.509
91604995|NCT05424276|183103414|SUPERIORITY||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|1.093||0.683|TWO_SIDED|95.0|-1.717|2.611||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo after 12 weeks of treatment||2.611|-1.717|0.683
91604996|NCT05424276|183103414|SUPERIORITY||Mean Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|1.08||0.212|TWO_SIDED|95.0|-0.783|3.495||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo after 12 weeks of treatment||3.495|-0.783|0.212
91604997|NCT05424276|183103414|SUPERIORITY||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|1.112||0.685|TWO_SIDED|95.0|-1.749|2.654||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo after 12 weeks of treatment||2.654|-1.749|0.685
91604998|NCT05424276|183103415|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.112||0.463|TWO_SIDED|95.0|-0.139|0.304||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of treatment||0.304|-0.139|0.463
91604999|NCT05424276|183103415|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.11||0.133|TWO_SIDED|95.0|-0.051|0.383||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.383|-0.051|0.133
91605000|NCT05424276|183103415|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.112||0.575|TWO_SIDED|95.0|-0.159|0.286||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.286|-0.159|0.575
91605001|NCT05424276|183103416|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.146||0.178|TWO_SIDED|95.0|-0.488|0.092||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 week of dosing||0.092|-0.488|0.178
91605002|NCT05424276|183103416|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.145||0.931|TWO_SIDED|95.0|-0.274|0.3||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.300|-0.274|0.931
91605003|NCT05424276|183103416|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.149||0.38|TWO_SIDED|95.0|-0.426|0.163||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.163|-0.426|0.380
91605004|NCT05424276|183103417|SUPERIORITY||Mean Difference (Net)|-0.98|STANDARD_ERROR_OF_MEAN|0.669||0.144|TWO_SIDED|95.0|-2.308|0.342||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.342|-2.308|0.144
91605005|NCT05424276|183103417|SUPERIORITY||Mean Difference (Net)|-1.41|STANDARD_ERROR_OF_MEAN|0.662||0.036|TWO_SIDED|95.0|-2.72|-0.096||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||-0.096|-2.720|0.036
91605006|NCT05424276|183103417|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.68||0.089|TWO_SIDED|95.0|-2.514|0.18||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.180|-2.514|0.089
91709565|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.7|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.7|
91709566|NCT04530838|183311598|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-4.0|||||TWO_SIDED|95.0|-9.5|1.2||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.2|-9.5|
91709567|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.9|||||TWO_SIDED|95.0|3.0|10.0||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|3.0|
91709568|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-33.5|||||TWO_SIDED|95.0|-40.7|-26.2||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-26.2|-40.7|
91709569|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
91709570|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-19.0|||||TWO_SIDED|95.0|-25.7|-12.5||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-12.5|-25.7|
91709571|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.5|||||TWO_SIDED|95.0|2.2|9.6||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||9.6|2.2|
91790915|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.868|TWO_SIDED|95.0|-1.026|1.217||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.217|-1.026|0.868
91523408|NCT03485911|182922431|SUPERIORITY||Difference in Least Square Means|-0.062||||0.025|TWO_SIDED|95.0|-0.117|-0.008|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.008|-0.117|0.025
91605007|NCT05424276|183103418|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|1.668||0.916|TWO_SIDED|95.0|-3.127|3.477||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||3.477|-3.127|0.916
91605008|NCT05424276|183103418|SUPERIORITY||Mean Difference (Net)|2.35|STANDARD_ERROR_OF_MEAN|1.652||0.158|TWO_SIDED|95.0|-0.921|5.621||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||5.621|-0.921|0.158
91605009|NCT05424276|183103418|SUPERIORITY||Mean Difference (Net)|2.41|STANDARD_ERROR_OF_MEAN|1.694||0.157|TWO_SIDED|95.0|-0.941|5.768||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||5.768|-0.941|0.157
91709572|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
91709573|NCT04530838|183311598|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.2|6.0||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||6.0|-3.2|
91709574|NCT04530838|183311598|OTHER||Percentage Difference|-5.7|||||TWO_SIDED|95.0|-10.4|-1.7||||||Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-1.7|-10.4|
91709575|NCT04530838|183311598|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.2|2.9||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.9|-5.2|
91709576|NCT04530838|183311598|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
91709577|NCT04530838|183311598|OTHER||Percentage Difference|0.7|||||TWO_SIDED|95.0|-4.5|5.8||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.8|-4.5|
91605010|NCT05424276|183103419|SUPERIORITY||Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|0.645||0.297|TWO_SIDED|95.0|-1.952|0.602||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.602|-1.952|0.297
91605011|NCT05424276|183103419|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|0.639||0.233|TWO_SIDED|95.0|-2.032|0.5||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.500|-2.032|0.233
91605012|NCT05424276|183103419|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.657||0.464|TWO_SIDED|95.0|-0.818|1.783||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||1.783|-0.818|0.464
91605013|NCT05424276|183103420|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|3.845||0.943|TWO_SIDED|95.0|-7.346|7.898||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||7.898|-7.346|0.943
91605014|NCT05424276|183103420|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|3.769||0.806|TWO_SIDED|95.0|-6.547|8.402||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||8.402|-6.547|0.806
91605015|NCT05424276|183103420|SUPERIORITY||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|3.884||0.794|TWO_SIDED|95.0|-6.686|8.719||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||8.719|-6.686|0.794
91651320|NCT00931385|183194642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.092|0.175|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.175|0.092|<0.0001
91651321|NCT00931385|183194643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.167|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.284|0.167|<0.0001
91651322|NCT00931385|183194643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.17|0.287|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.287|0.170|<0.0001
91605016|NCT05424276|183103421|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.654||0.173|TWO_SIDED|95.0|-2.193|0.4||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.400|-2.193|0.173
91605017|NCT05424276|183103421|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.644||0.393|TWO_SIDED|95.0|-1.828|0.725||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.725|-1.828|0.393
91605018|NCT05424276|183103421|SUPERIORITY||Mean Difference (Net)|-0.96|STANDARD_ERROR_OF_MEAN|0.648||0.141|TWO_SIDED|95.0|-2.246|0.323||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.323|-2.246|0.141
91605019|NCT05424276|183103422|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.578||0.704|TWO_SIDED|95.0|-0.925|1.366||Study not sized for efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||1.366|-0.925|0.704
91605020|NCT05424276|183103422|SUPERIORITY||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.564||0.506|TWO_SIDED|95.0|-0.742|1.494||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||1.494|-0.742|0.506
91605021|NCT05424276|183103422|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.578||0.888|TWO_SIDED|95.0|-1.227|1.063||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||1.063|-1.227|0.888
91651323|NCT00931385|183194643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.262|0.144|<0.0001
91709578|NCT04530838|183311598|OTHER||Percentage Difference|4.8|||||TWO_SIDED|95.0|-0.2|10.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|-0.2|
91709579|NCT04530838|183311598|OTHER||Percentage Difference|-5.6|||||TWO_SIDED|95.0|-12.5|1.1||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.1|-12.5|
91709580|NCT04530838|183311598|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.4|3.1||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.1|-5.4|
91709581|NCT04530838|183311598|OTHER||Percentage Difference|-3.0|||||TWO_SIDED|95.0|-7.7|1.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.4|-7.7|
91787731|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.7||0.467|TWO_SIDED|95.0|-5.6|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-5.6|0.467
91790916|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91605022|NCT05424276|183103423|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.014||0.004|TWO_SIDED|95.0|0.013|0.067||Study was not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.067|0.013|0.004
91605023|NCT05424276|183103423|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.125|TWO_SIDED|95.0|-0.006|0.047||Study was not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.047|-0.006|0.125
91605024|NCT05424276|183103423|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.014||0.179|TWO_SIDED|95.0|-0.009|0.046||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.046|-0.009|0.179
91605025|NCT05424276|183103424|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.095||0.321|TWO_SIDED|95.0|-0.283|0.094||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.094|-0.283|0.321
91605026|NCT05424276|183103424|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.444|TWO_SIDED|95.0|-0.259|0.114||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.114|-0.259|0.444
91605027|NCT05424276|183103424|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.097||0.154|TWO_SIDED|95.0|-0.332|0.053||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.053|-0.332|0.154
91605028|NCT05424276|183103425|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.104||0.95|TWO_SIDED|95.0|-0.199|0.212||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.212|-0.199|0.950
91605029|NCT05424276|183103425|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.102||0.189|TWO_SIDED|95.0|-0.338|0.067||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.067|-0.338|0.189
91605030|NCT05424276|183103425|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.105||0.374|TWO_SIDED|95.0|-0.301|0.114|||Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.114|-0.301|0.374
91605031|NCT05424276|183103426|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.058||0.803|TWO_SIDED|95.0|-0.101|0.131||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.131|-0.101|0.803
91605032|NCT05424276|183103426|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.058||0.935|TWO_SIDED|95.0|-0.11|0.12||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.120|-0.110|0.935
91605033|NCT05424276|183103426|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.968|TWO_SIDED|95.0|-0.116|0.121||Study not sized to evaluate efficacy|Mixed Models Analysis|||Change relative to placebo at 12 weeks of dosing||0.121|-0.116|0.968
91605034|NCT02073487|183103473|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
91605035|NCT02886702|183103480|EQUIVALENCE|90% confidence interval on the difference between the proportions to be within \[-20%, +20%\].|Risk Difference (RD)|-4.5||||||90.0|-12.6|3.6||p-value not calculated|Yates' corrected confidence interval|||||3.6|-12.6|
91605036|NCT02886702|183103480|SUPERIORITY|Last Observation Carried Forward (LOCF) for missing efficacy values||||||0.352|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.3520
91605037|NCT02886702|183103481|SUPERIORITY|||||||0.8105|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.8105
91605038|NCT02886702|183103481|SUPERIORITY|||||||0.0613|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0613
91605039|NCT02886702|183103482|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||1.0000
91605040|NCT02886702|183103482|SUPERIORITY|||||||0.0712|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0712
91605041|NCT00054847|183103489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.82|TWO_SIDED|95.0|0.62|1.84||Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.|Chi-squared|We performed as-treated and per-protocol analyses \& multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.||The study was designed to have 90% power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5%and an expected 1-year catheterization completion rate of 65%.||1.84|.62|.82
91605042|NCT00054847|183103490|SUPERIORITY_OR_OTHER|||||||0.61|||||||Chi-squared|||||||.61
91605043|NCT00054847|183103491|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>.99
91605044|NCT01147926|183103494|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91605045|NCT02207907|183103533|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.491|||<|0.0001|TWO_SIDED|95.0|-20.317|-14.664|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-14.664|-20.317|<0.0001
91790917|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.592||0.82|TWO_SIDED|95.0|-1.298|1.029||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.029|-1.298|0.820
91790918|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91709582|NCT04530838|183311598|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.2|-4.4|
91651324|NCT00931385|183194644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.087|0.207|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.087|<0.0001
91651325|NCT00931385|183194644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.112|0.231|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.231|0.112|<0.0001
91651326|NCT00931385|183194644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.191|0.311|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.311|0.191|<0.0001
91651327|NCT00931385|183194645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.132|0.241|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.241|0.132|<0.0001
91709583|NCT04530838|183311598|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
91709584|NCT04530838|183311598|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.0|1.7||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-3.0|
91523409|NCT03485911|182922431|SUPERIORITY||Difference in Least Square Means|-0.078||||0.006|TWO_SIDED|95.0|-0.133|-0.023|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of number and proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.023|-0.133|0.006
91523410|NCT03485911|182922432|SUPERIORITY||negative binomial regression model|30.4||||0.026|TWO_SIDED|95.0|4.3|49.3|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||49.3|4.3|0.026
91651328|NCT00931385|183194645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.145|0.254|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.254|0.145|<0.0001
91651329|NCT00931385|183194645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.172|0.282|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.282|0.172|<0.0001
91709585|NCT04530838|183311598|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
91709586|NCT04530838|183311598|OTHER||Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.9|5.1||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.1|-6.9|
91709587|NCT04530838|183311598|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.2|
91709588|NCT04530838|183311598|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-9.8|8.6||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.6|-9.8|
91709589|NCT04530838|183311598|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
91709590|NCT04530838|183311598|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-8.2|8.2||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.2|-8.2|
91709591|NCT04530838|183311598|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.0||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.0|-3.3|
91523411|NCT03485911|182922432|SUPERIORITY||negative binomial regression model|46.5|||<|0.001|TWO_SIDED|95.0|25.6|61.5|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||61.5|25.6|<0.001
91605046|NCT02207907|183103534|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.201|||<|0.0001|TWO_SIDED|95.0|-0.237|-0.165|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.165|-0.237|<0.0001
91605047|NCT01025635|183103548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|study center adjusted||||||0.017
91605048|NCT01025635|183103549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|with factors treatment group, study center, and baseline lesion count as covariate||||||<0.001
91605049|NCT00929240|183103580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.|Log Rank||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|||0.551|0.266|<0.0001
91605050|NCT00929240|183103580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.429|||<|0.0001|TWO_SIDED|95.0|0.309|0.597|||Log Rank|Unstratified analysis||||0.597|0.309|<0.0001
91605051|NCT00929240|183103581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.113|TWO_SIDED|95.0|-2.1|20.3|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.|||20.3|-2.1|0.113
91605052|NCT00929240|183103582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-2.6|4.6|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.|||4.6|-2.6|0.580
91605053|NCT00929240|183103584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0003|TWO_SIDED|95.0|0.263|0.685||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank|||||0.685|0.263|<0.0003
91605054|NCT00929240|183103584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516||||0.002|TWO_SIDED|95.0|0.334|0.798||Unstratified analysis|Log Rank|||||0.798|0.334|0.002
91605055|NCT00929240|183103587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.|||0.551|0.266|<0.0001
91651330|NCT00931385|183194646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.191|0.33|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.330|0.191|<0.0001
91651331|NCT00931385|183194646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.183|0.322|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.322|0.183|<0.0001
91523412|NCT00462280|182922486|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
91605056|NCT00929240|183103587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.305|0.591||Unstratified analysis|Log Rank||Hazard ratio was determined using the cox regression model.|||0.591|0.305|<0.0001
91605057|NCT01834404|183103591|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||ANCOVA|||||||0.057
91605058|NCT01834404|183103592|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||||||0.052
91605059|NCT01834404|183103593|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
91651332|NCT00931385|183194646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.232|0.372|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.372|0.232|<0.0001
91523413|NCT01987817|182922523|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.0001|TWO_SIDED|95.0|35.0|79.0|||Fisher Exact|||||79|35|<0.0001
91605060|NCT01834404|183103594|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|||||||0.99
91605061|NCT01834404|183103595|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||||||0.45
91605062|NCT01834404|183103596|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
91605063|NCT01834404|183103597|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||||||0.032
91605064|NCT01834404|183103598|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This p-value was based on a rank transformation.||||0.030
91605065|NCT01834404|183103599|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANCOVA|||||||0.35
91605066|NCT01834404|183103600|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|||||||0.72
91605067|NCT01834404|183103601|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANCOVA|||||||0.90
91605068|NCT01834404|183103602|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
91605069|NCT01834404|183103603|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
91605070|NCT01276288|183103625|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.08|STANDARD_DEVIATION|11.8||0.0092|TWO_SIDED|90.0|97.11|118.07||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||118.07|97.11|0.0092
91605071|NCT01276288|183103625|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.83|STANDARD_DEVIATION|8.9||0.003|TWO_SIDED|90.0|100.14|116.11||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.11|100.14|0.0030
91605072|NCT01276288|183103626|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.78|STANDARD_DEVIATION|18.3||0.0199|TWO_SIDED|90.0|88.55|119.29||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||119.29|88.55|0.0199
91709592|NCT04530838|183311598|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
91605073|NCT01276288|183103626|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.5|STANDARD_DEVIATION|11.3||0.0086|TWO_SIDED|90.0|97.9|118.04||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||118.04|97.90|0.0086
91605074|NCT01276288|183103627|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|96.27|STANDARD_DEVIATION|9.6||0.0008|TWO_SIDED|90.0|89.08|104.05||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||104.05|89.08|0.0008
91605075|NCT01276288|183103628|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.77|STANDARD_DEVIATION|17.1||0.0114|TWO_SIDED|90.0|88.63|116.85||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||116.85|88.63|0.0114
91605076|NCT01276288|183103629|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.44|STANDARD_DEVIATION|2.9|<|0.0001|TWO_SIDED|90.0|99.06|103.88||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||103.88|99.06|<0.0001
91605077|NCT01276288|183103629|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.42|STANDARD_DEVIATION|4.8|<|0.0001|TWO_SIDED|90.0|100.39|108.62||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||108.62|100.39|<0.0001
91605078|NCT01276288|183103629|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|103.19|STANDARD_DEVIATION|8.9||0.0005|TWO_SIDED|90.0|95.93|111.01||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.01|95.93|0.0005
91605079|NCT01276288|183103630|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.43|STANDARD_DEVIATION|13.1||0.0066|TWO_SIDED|90.0|93.81|116.25||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.25|93.81|0.0066
91605080|NCT01276288|183103630|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.67|STANDARD_DEVIATION|10.6||0.0012|TWO_SIDED|90.0|94.13|111.97||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.97|94.13|0.0012
91605081|NCT01276288|183103630|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.42|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|97.65|107.42||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||107.42|97.65|<0.0001
91651333|NCT00931385|183194647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.087|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.221|0.087|<0.0001
91651334|NCT00931385|183194647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.086|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.221|0.086|<0.0001
91651335|NCT00931385|183194647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.115|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.115|<0.0001
91651336|NCT02033876|183194649|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
91651337|NCT02033876|183194650|SUPERIORITY|||||||0.65|||||||ANCOVA|||||||0.65
91651338|NCT02033876|183194652|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
91651339|NCT02033876|183194653|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
91651340|NCT02033876|183194654|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.4
91651341|NCT02033876|183194655|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.8
91651342|NCT02033876|183194656|SUPERIORITY|||||||0.006|||||||ANCOVA|||||||0.006
91709593|NCT04530838|183311598|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-7.5|2.2||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.2|-7.5|
91790919|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.583||0.781|TWO_SIDED|95.0|-0.984|1.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.308|-0.984|0.781
91605082|NCT01478958|183103648|SUPERIORITY_OR_OTHER|||||||0.238||||||Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.||To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.||||0.238
91605083|NCT01478958|183103648|SUPERIORITY_OR_OTHER|||||||0.021||||||Effect of the SFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||0.021
91605084|NCT01478958|183103648|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of MUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
91605085|NCT01478958|183103648|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of n-6 PUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
91605086|NCT05003115|183103660|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-6.36||||0.101|TWO_SIDED|95.0|-14.17|1.44|||Regression, Linear|||||1.44|-14.17|0.101
91605087|NCT05003115|183103661|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||Regression, Linear|||||0.59|-0.79|0.78
91605088|NCT05003115|183103662|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.95||||0.314|TWO_SIDED|95.0|-2.83|0.94|||Regression, Linear|||||0.94|-2.83|0.314
91605089|NCT05003115|183103663|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.04||||0.679|TWO_SIDED|95.0|-6.0|3.92|||Regression, Linear|||||3.92|-6.00|0.679
91605090|NCT05003115|183103664|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|0.01||||0.994|TWO_SIDED|95.0|-2.23|2.25|||Regression, Linear|||||2.25|-2.23|0.994
91605091|NCT05003115|183103665|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.22||||0.258|TWO_SIDED|95.0|-3.33|0.89|||Regression, Linear|||||0.89|-3.33|0.258
91605092|NCT05003115|183103666|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.4||||0.857|TWO_SIDED|95.0|-4.75|3.96|||Regression, Linear|||||3.96|-4.75|0.857
91605093|NCT01147809|183103673|SUPERIORITY_OR_OTHER||Percent difference|21.1||||0.103|TWO_SIDED|95.0|-3.9|52.5|||ANCOVA|||||52.5|-3.9|0.103
91605094|NCT01147809|183103695|SUPERIORITY_OR_OTHER||Percent difference|12.9||||0.407|TWO_SIDED|95.0|-15.6|51.1|||ANCOVA|||||51.1|-15.6|0.407
91605095|NCT01147809|183103696|SUPERIORITY_OR_OTHER||Percent difference|-4.4||||0.802|TWO_SIDED|95.0|-33.5|37.4|||ANCOVA|||||37.4|-33.5|0.802
91605096|NCT01307423|183103704|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.1||||0.0062|TWO_SIDED|95.0|3.5|20.7|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.7|3.5|0.0062
91605097|NCT01307423|183103704|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|6.1|23.5|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||23.5|6.1|0.0010
91605098|NCT01307423|183103705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0008|TWO_SIDED|95.0|-0.265|-0.071|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.071|-0.265|0.0008
91605099|NCT01307423|183103705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.217|||<|0.0001|TWO_SIDED|95.0|-0.314|-0.12|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.120|-0.314|<.0001
91605100|NCT01307423|183103706|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1||||0.0002|TWO_SIDED|95.0|7.7|24.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.4|7.7|0.0002
91605101|NCT01307423|183103706|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4||||0.0063|TWO_SIDED|95.0|3.3|19.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.4|3.3|0.0063
91605102|NCT01307423|183103707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0014|TWO_SIDED|95.0|-0.271|-0.065||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.065|-0.271|0.0014
91605103|NCT01307423|183103707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.219|||<|0.0001|TWO_SIDED|95.0|-0.322|-0.117||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.117|-0.322|<.0001
91605104|NCT01307423|183103708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.38||||0.0043|TWO_SIDED|95.0|0.75|4.01||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.01|0.75|0.0043
91605105|NCT01307423|183103708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.18||||0.0002|TWO_SIDED|95.0|1.55|4.82||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.82|1.55|0.0002
91605106|NCT01307423|183103709|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.4||||0.0037|TWO_SIDED|95.0|4.8|24.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.0|4.8|0.0037
91605107|NCT01307423|183103709|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.0|||<|0.0001|TWO_SIDED|95.0|11.3|30.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||30.7|11.3|<.0001
91605108|NCT01307423|183103710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.0485|TWO_SIDED|95.0|-10.0|0.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-0.0|-10.0|0.0485
91605109|NCT01307423|183103710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.8||||0.0022|TWO_SIDED|95.0|-12.8|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-2.8|-12.8|0.0022
91605110|NCT01307423|183103711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.7696|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||0.6|-0.8|0.7696
91651343|NCT01360632|183194660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0925|TWO_SIDED|95.0|-2.58|0.2|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||0.2|-2.58|0.0925
91651344|NCT01360632|183194660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0327|TWO_SIDED|95.0|-2.92|-0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-0.13|-2.92|0.0327
91651345|NCT01360632|183194661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0737|TWO_SIDED|95.0|-2.73|0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.13|-2.73|0.0737
91787732|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.557|TWO_SIDED|95.0|-5.4|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.5|-5.4|0.557
91605111|NCT01307423|183103711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.0038|TWO_SIDED|95.0|-1.7|-0.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.3|-1.7|0.0038
91605112|NCT01307423|183103712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.2|-1.6|
91605113|NCT01307423|183103712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.4|0.0|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.0|-1.4|
91605114|NCT01307423|183103713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.91|||||TWO_SIDED|95.0|-7.04|-2.78|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-2.78|-7.04|
91787733|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.593|TWO_SIDED|95.0|-5.3|1.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.6|-5.3|0.593
91787734|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.776|TWO_SIDED|95.0|-1.0|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.0|0.776
91787735|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.446|TWO_SIDED|95.0|-1.2|0.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.3|-1.2|0.446
91787736|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.649|TWO_SIDED|95.0|-1.1|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.1|0.649
91787737|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.3||0.452|TWO_SIDED|95.0|-4.1|0.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.9|-4.1|0.452
91787738|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.3||0.665|TWO_SIDED|95.0|-3.7|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-3.7|0.665
91605115|NCT01307423|183103713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.65|||||TWO_SIDED|95.0|-7.78|-3.51|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-3.51|-7.78|
91605116|NCT01307423|183103714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.67|-0.25|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.25|-0.67|<0.0001
91787739|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.3||0.598|TWO_SIDED|95.0|-3.9|1.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.2|-3.9|0.598
91605117|NCT01307423|183103714|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.32|-0.74|<0.0001
91651346|NCT01360632|183194661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.0079|TWO_SIDED|95.0|-3.39|-0.51|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.51|-3.39|0.0079
91605118|NCT01307423|183103715|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.12|||||TWO_SIDED|95.0|-0.63|2.87|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||2.87|-0.63|
91605119|NCT01307423|183103715|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.55|||||TWO_SIDED|95.0|0.8|4.31|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||4.31|0.80|
91787740|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.400
91787741|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.393|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.393
91605120|NCT01307423|183103716|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|1.97|||||TWO_SIDED|95.0|0.28|3.65|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||3.65|0.28|
91787742|NCT03595618|183455327|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.858|TWO_SIDED|95.0|-0.5|0.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.2|-0.5|0.858
91605121|NCT01307423|183103716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.72|||||TWO_SIDED|95.0|2.02|5.41|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||5.41|2.02|
91605122|NCT01307423|183103717|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.5|||||TWO_SIDED|95.0|10.5|28.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||28.6|10.5|
91605123|NCT01307423|183103717|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.2|||||TWO_SIDED|95.0|9.2|27.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||27.2|9.2|
91605124|NCT01307423|183103718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.6|||||TWO_SIDED|95.0|-10.6|-0.5|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.5|-10.6|
91605125|NCT01307423|183103718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.7|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.7|-10.8|
91605126|NCT01307423|183103719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.4|-1.0|
91651347|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.0096|TWO_SIDED|95.0|-1.86|-0.26|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.26|-1.86|0.0096
91651348|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.4137|TWO_SIDED|95.0|-1.14|0.47|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.47|-1.14|0.4137
91605127|NCT01307423|183103719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.2|-1.6|
91605128|NCT01307423|183103720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|||||TWO_SIDED|95.0|-1.7|-0.3|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.3|-1.7|
91605129|NCT01307423|183103720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.1|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.1|-1.4|
91605130|NCT01307423|183103721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.31|-2.84|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.84|-7.31|
91605131|NCT01307423|183103721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.14|||||TWO_SIDED|95.0|-7.38|-2.89|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.89|-7.38|
91605132|NCT01307423|183103722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.23|||ANCOVA||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.23|-0.70|<0.0001
91790920|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91651349|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0065|TWO_SIDED|95.0|-2.47|-0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.4|-2.47|0.0065
91790921|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.59||0.895|TWO_SIDED|95.0|-1.082|1.238||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.238|-1.082|0.895
91605133|NCT01307423|183103722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46||||0.0001|TWO_SIDED|95.0|-0.69|-0.22|||ANCOVA||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.22|-0.69|0.0001
91605134|NCT01307423|183103723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.12|||||TWO_SIDED|95.0|-0.68|2.93|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||2.93|-0.68|
91605135|NCT01307423|183103723|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.33|||||TWO_SIDED|95.0|0.52|4.15|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||4.15|0.52|
91605136|NCT01307423|183103724|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-10.2|15.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||15.5|-10.2|
91605137|NCT01307423|183103724|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.0|||||TWO_SIDED|95.0|4.2|29.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||29.8|4.2|
91605138|NCT01307423|183103725|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-7.8|20.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.4|-7.8|
91605139|NCT01307423|183103725|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-12.6|16.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||16.4|-12.6|
91605140|NCT01307423|183103726|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||||TWO_SIDED|95.0|6.4|25.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.8|6.4|
91605141|NCT01307423|183103726|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||||TWO_SIDED|95.0|9.6|29.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.1|9.6|
91605142|NCT01307423|183103727|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-6.8|18.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||18.8|-6.8|
91605143|NCT01307423|183103727|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.0|||||TWO_SIDED|95.0|5.3|30.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||30.6|5.3|
91605144|NCT01307423|183103728|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.1|25.9|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.9|-2.1|
91605145|NCT01307423|183103728|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.3|||||TWO_SIDED|95.0|-9.2|19.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.8|-9.2|
91605146|NCT01307423|183103729|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|8.8|26.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||26.8|8.8|
91605147|NCT01307423|183103729|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4|||||TWO_SIDED|95.0|2.7|20.0|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.0|2.7|
91605148|NCT01307423|183103730|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.9|||||TWO_SIDED|95.0|1.3|12.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.5|1.3|
91605149|NCT01307423|183103730|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|1.2|12.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.4|1.2|
91605150|NCT01307423|183103731|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9|||||TWO_SIDED|95.0|-0.4|6.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.2|-0.4|
91605151|NCT01307423|183103731|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-0.4|6.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.1|-0.4|
91605152|NCT01307423|183103732|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||||TWO_SIDED|95.0|3.2|16.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||16.3|3.2|
91605153|NCT01307423|183103732|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.2|12.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||12.3|0.2|
91605154|NCT01307423|183103733|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.1|4.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.1|-4.1|
91651350|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.0914|TWO_SIDED|95.0|-1.93|0.14|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.14|-1.93|0.0914
91651351|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0139|TWO_SIDED|95.0|-2.5|-0.28|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.28|-2.5|0.0139
91651352|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.2097|TWO_SIDED|95.0|-1.82|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.4|-1.82|0.2097
91651353|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0099|TWO_SIDED|95.0|-2.75|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.38|-2.75|0.0099
91709594|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.62|||||TWO_SIDED|95.0|0.54|0.72||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.72|0.54|
91787743|NCT03595618|183455328|SUPERIORITY||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.5||0.705|TWO_SIDED|95.0|-7.1|2.7||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.7|-7.1|0.705
91605155|NCT01307423|183103733|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-3.7|4.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.8|-3.7|
91605156|NCT01307423|183103734|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-8.1|12.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.6|-8.1|
91605157|NCT01307423|183103734|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|6.3|29.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.3|6.3|
91605158|NCT01307423|183103735|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.4|||||TWO_SIDED|95.0|-4.8|23.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||23.5|-4.8|
91605159|NCT01307423|183103735|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-7.2|21.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||21.5|-7.2|
91605160|NCT01307423|183103736|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-4.8|17.7|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||17.7|-4.8|
91605161|NCT01307423|183103736|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|3.4|27.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||27.1|3.4|
91605162|NCT01307423|183103737|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5|||||TWO_SIDED|95.0|-3.8|24.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.8|-3.8|
91605163|NCT01307423|183103737|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-9.5|19.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.3|-9.5|
91605164|NCT00805207|183103777|OTHER|||||||0.85|||||||t-test, 2 sided|||||||0.85
91605165|NCT00805207|183103777|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
91605166|NCT00805207|183103777|OTHER|||||||0.88||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.88
91605167|NCT00805207|183103777|OTHER|||||||0.26||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.26
91605168|NCT00805207|183103777|OTHER|||||||0.98||||||P value is the group by treatment interaction from the ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.98
91605169|NCT00805207|183103778|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
91605170|NCT00805207|183103778|OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
91605171|NCT00805207|183103778|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
91605172|NCT00805207|183103778|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
91605173|NCT00805207|183103778|OTHER|||||||0.57|||||||ANCOVA|||||||0.57
91605174|NCT00805207|183103779|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
91605175|NCT00805207|183103779|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
91605176|NCT00805207|183103779|OTHER|||||||0.53|||||||ANCOVA|||||||0.53
91605177|NCT00805207|183103779|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
91605178|NCT00805207|183103780|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
91605179|NCT00805207|183103781|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91605180|NCT00805207|183103781|OTHER||||||<|0.01||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|||||||<0.01
91605181|NCT00805207|183103781|OTHER|||||||0.96||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|||||||0.96
91787744|NCT03595618|183455328|SUPERIORITY||Adjusted mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.243|TWO_SIDED|95.0|-9.0|0.8||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.8|-9.0|0.243
91787745|NCT03595618|183455328|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.949|TWO_SIDED|95.0|-6.1|3.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.9|-6.1|0.949
91787746|NCT03595618|183455329|SUPERIORITY||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.89|TWO_SIDED|95.0|-3.4|6.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||6.3|-3.4|0.890
91787747|NCT03595618|183455329|SUPERIORITY||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.5||0.682|TWO_SIDED|95.0|-7.1|2.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.6|-7.1|0.682
91787748|NCT03595618|183455329|SUPERIORITY||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.5||1|TWO_SIDED|95.0|-4.8|5.0||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||5.0|-4.8|1.000
91790922|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|4.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91605182|NCT00805207|183103781|OTHER||||||<|0.05||||||P value is the group by treatment interaction from the ANOVA|ANOVA|||||||<0.05
91790923|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|0.69||0.359|TWO_SIDED|95.0|-0.724|1.991||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.991|-0.724|0.359
91605183|NCT00805207|183103781|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
91605184|NCT00805207|183103781|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
91790924|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91605185|NCT00805207|183103781|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
91605186|NCT00805207|183103781|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
91605187|NCT00064701|183103782|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-1.9|||||TWO_SIDED|95.2|-8.9|5.2||||||||5.2|-8.9|
91605188|NCT00064701|183103782|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.0|||||TWO_SIDED|95.2|-9.9|4.0||||||||4.0|-9.9|
91605189|NCT00064701|183103783|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.3|||||TWO_SIDED|95.0|-7.2|0.6||||||||0.6|-7.2|
91605190|NCT00064701|183103783|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||||3.2|-3.1|
91605191|NCT00064701|183103784|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.8|||||TWO_SIDED|95.0|-8.5|0.9||||||||0.9|-8.5|
91605192|NCT00064701|183103784|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||||4.1|-4.0|
91605193|NCT00064701|183103785|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-8.0|||||TWO_SIDED|95.0|-13.1|-3.0||||||Comparison of tacrolimus with cyclosporine at 6 months||-3.0|-13.1|
91605194|NCT00064701|183103785|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-3.8|||||TWO_SIDED|95.0|-9.5|1.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 6 months||1.8|-9.5|
91605195|NCT00064701|183103785|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 Months|-6.1|||||TWO_SIDED|95.0|-12.0|-0.3||||||Comparison of tacrolimus with cyclosporine at 12 months||-0.3|-12.0|
91605196|NCT00064701|183103785|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 months|-3.4|||||TWO_SIDED|95.0|-9.6|2.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 12 months||2.8|-9.6|
91605197|NCT00064701|183103795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-6.5|5.5||||||||5.5|-6.5|
91605198|NCT00064701|183103795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-3.9|6.9||||||||6.9|-3.9|
91605199|NCT00064701|183103796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-9.1|6.6||||||||6.6|-9.1|
91605200|NCT00064701|183103796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-7.1|8.6||||||||8.6|-7.1|
91651354|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.034|TWO_SIDED|95.0|-2.48|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.1|-2.48|0.034
91651355|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0177|TWO_SIDED|95.0|-2.8|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.27|-2.8|0.0177
91651356|NCT01360632|183194662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0085|TWO_SIDED|95.0|-2.98|-0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.44|-2.98|0.0085
91651357|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0286|TWO_SIDED|95.0|-1.74|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.1|-1.74|0.0286
91651358|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3173|TWO_SIDED|95.0|-1.24|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.4|-1.24|0.3173
91605201|NCT01818297|183103797|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|10.5||0.14|ONE_SIDED|95.0|-5.8|||Due to early termination, the study was insufficiently powered to test the primary objective. This analysis is exploratory and descriptive in nature and cannot be considered conclusive.|Z-test|The Z-test (using an unpooled standard deviation, without continuity correction) was used to test the difference in responder rates between groups.|The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group.|The original sample size estimate for the primary objective was based on the following assumptions: 109 subjects in each arm with a responder rate of 22% in the Control group and 40% in the Treatment group, and a one-sided α= 0.05 using a Z test with unpooled variance, would result in 90% power. Because the study terminated early, the actual sample size (32 in Treatment, 30 in Control) resulted in 47% power under the same assumptions.|||-5.8|0.14
91651359|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0313|TWO_SIDED|95.0|-2.23|-0.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.11|-2.23|0.0313
91651360|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0732|TWO_SIDED|95.0|-2.04|0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.09|-2.04|0.0732
91651361|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0206|TWO_SIDED|95.0|-2.51|-0.21|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.21|-2.51|0.0206
91651362|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.1233|TWO_SIDED|95.0|-2.06|0.25|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.25|-2.06|0.1233
91605202|NCT02630953|183103845|SUPERIORITY||Median Difference (Final Values)|-6.22||||0.24|TWO_SIDED|95.0|-41.15|28.7||Significance level was set at .05 a priori.|quantile regression|Bootstrapped standard errors (10,000 replications)||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-ups, controlling for baseline. Quantile regression models the median outcome instead of the mean, and are appropriate when data is skewed (as was the case in both self-reported and objectively measured MVPA).||28.70|-41.15|0.24
91605203|NCT02630953|183103846|SUPERIORITY||Median Difference (Final Values)|7.5||||0.73|TWO_SIDED|95.0|-32.37|47.37||Significance was set at .05 a priori|quantile regression|||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-up, controlling for baseline||47.37|-32.37|0.73
91605204|NCT02630953|183103847|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.035|>|0.06|TWO_SIDED|||||Significance level set at .05 a priori|Regression, Linear|||Using a series of generalized linear models with identity link, we examined treatment effects on biomarkers at 6 months controlling for baseline and potential confounders.||||>.06
91605205|NCT01957137|183103891|SUPERIORITY_OR_OTHER|||||||0.3773|||||||Mixed Models Analysis|The final model included cycling, period and the interaction between cycling and period.||||||0.3773
91605206|NCT01957137|183103892|SUPERIORITY_OR_OTHER|||||||0.2396|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.2396
91651363|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0097|TWO_SIDED|95.0|-2.84|-0.39|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.39|-2.84|0.0097
91787749|NCT03595618|183455330|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.21||0.991|TWO_SIDED|95.0|0.7|1.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.58|0.70|0.991
91787750|NCT03595618|183455330|SUPERIORITY||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.21||0.992|TWO_SIDED|95.0|0.64|1.43||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.43|0.64|0.992
91605207|NCT01957137|183103893|SUPERIORITY_OR_OTHER|||||||0.8874|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.8874
91605208|NCT02901431|183103948|SUPERIORITY||Difference in Adjusted LSMeans|-0.16||||0.911|TWO_SIDED|90.0|-2.56|2.23|||Mixed Models Analysis|||||2.23|-2.56|0.911
91605209|NCT02901431|183103949|SUPERIORITY||Difference in adjused LSMean|0.29|||||TWO_SIDED|90.0|-1.85|2.43||||||Week 12||2.43|-1.85|
91605210|NCT02901431|183103949|SUPERIORITY||Difference in adjusted LSMean|-0.23|||||TWO_SIDED|90.0|-2.67|2.22||||||Week 24||2.22|-2.67|
91605211|NCT02901431|183103950|SUPERIORITY||Difference in adjusted LSMean|-0.22|||||TWO_SIDED|90.0|-2.36|1.92||||||Communication Domain Standard Score, Week 12||1.92|-2.36|
91605212|NCT02901431|183103950|SUPERIORITY||Difference in adjusted LSMean|0.71|||||TWO_SIDED|90.0|-1.6|3.02||||||Communication Domain Standard Score, Week 24||3.02|-1.60|
91605213|NCT02901431|183103950|SUPERIORITY||Difference in adjusted LSMean|0.51|||||TWO_SIDED|90.0|-2.1|3.12||||||Socialization Domain Standard Score, Week 12||3.12|-2.10|
91605214|NCT02901431|183103950|SUPERIORITY|Socialization Domain Standard Score, Week 24|Difference in adjusted LSMean|-0.61|||||TWO_SIDED|90.0|-3.74|2.51||||||||2.51|-3.74|
91605215|NCT02901431|183103950|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 12|Difference in adjusted LSMean|2.14|||||TWO_SIDED|90.0|-0.63|4.9||||||||4.90|-0.63|
91605216|NCT02901431|183103950|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 24|Differences in adjusted LSMean|0.18|||||TWO_SIDED|90.0|-2.87|3.22||||||||3.22|-2.87|
91605217|NCT02901431|183103956|SUPERIORITY||Difference of Adjusted LS Means|3.74|||||TWO_SIDED|90.0|0.78|6.7|||Mixed Models Analysis|||Week 12||6.70|0.78|
91605218|NCT02901431|183103956|SUPERIORITY||Difference of Adjusted LS means|2.28|||||TWO_SIDED|90.0|-0.73|5.29||||||Week 24||5.29|-0.73|
91605219|NCT02901431|183103958|SUPERIORITY||Difference in Adjusted LS Means|0.01||||0.992|TWO_SIDED|90.0|-1.99|2.01|||Mixed Models Analysis|||||2.01|-1.99|0.992
91605220|NCT00046228|183104024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.551||95.0|0.67|1.23||The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.|Log Rank|Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death \& resuscitated v fib assessed by the investigator)||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.||1.23|0.67|0.551
91787751|NCT03595618|183455330|SUPERIORITY||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.21||0.653|TWO_SIDED|95.0|0.55|1.23||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.23|0.55|0.653
91790925|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.675||0.612|TWO_SIDED|95.0|-0.985|1.67||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.670|-0.985|0.612
91790926|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91709595|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.71|||||TWO_SIDED|95.0|0.63|0.81||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.81|0.63|
91605221|NCT00046228|183104024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.858||95.0|0.72|1.31|||Log Rank|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%||1.31|0.72|0.858
91605222|NCT00046228|183104024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.676||95.0|0.69|1.27|||Log Rank|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.||1.27|0.69|0.676
91605223|NCT00046228|183104025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.247||95.0|0.57|1.16|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.16|0.57|0.247
91605224|NCT00046228|183104025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.278||95.0|0.58|1.17|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.17|0.58|0.278
91605225|NCT00046228|183104025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.944||95.0|0.68|1.43|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.||1.43|0.68|0.944
91605226|NCT00046228|183104026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.494||95.0|0.74|1.84|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.84|0.74|0.494
91605227|NCT00046228|183104026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.338||95.0|0.79|1.95|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.95|0.79|0.338
91605228|NCT00046228|183104026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.781||95.0|0.61|1.45|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.||1.45|0.61|0.781
91605229|NCT00046228|183104027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.016||95.0|1.08|2.1|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||2.10|1.08|0.016
91605230|NCT00046228|183104027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.67||95.0|0.76|1.52|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||1.52|0.76|0.670
91605231|NCT00046228|183104027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.042||95.0|1.01|1.93|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution \>70% from baseline.||1.93|1.01|0.042
91605232|NCT00046228|183104028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.603||95.0|0.62|1.32|||Log Rank|||||1.32|0.62|0.603
91605233|NCT00046228|183104028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.765||95.0|0.73|1.52|||Log Rank|||||1.52|0.73|0.765
91605234|NCT00046228|183104028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.415||95.0|0.59|1.24|||Log Rank|||||1.24|0.59|0.415
91605235|NCT00046228|183104029|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.218
91605236|NCT00046228|183104029|SUPERIORITY_OR_OTHER|||||||0.497||95.0|||||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.497
91605237|NCT00046228|183104029|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.||||0.062
91605238|NCT00046228|183104030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001||95.0|1.63|3.19|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||3.19|1.63|<0.001
91605239|NCT00046228|183104030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.025||95.0|1.05|2.15|||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||2.15|1.05|0.025
91605240|NCT00046228|183104030|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.008||95.0|1.12|2.05|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.||2.05|1.12|0.008
91605241|NCT00046228|183104031|SUPERIORITY_OR_OTHER|||||||0.439||95.0|||||Fisher Exact|||||||0.439
91605242|NCT00046228|183104031|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Fisher Exact|||||||0.438
91605243|NCT00046228|183104031|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
91605244|NCT00046228|183104032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91605245|NCT00046228|183104032|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.020
91605246|NCT00046228|183104032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91605247|NCT00046228|183104033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.434||95.0|0.69|1.18|||Chi-squared|||||1.18|0.69|0.434
91605248|NCT00046228|183104033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.589||95.0|0.71|1.22|||Chi-squared|||||1.22|0.71|0.589
91605249|NCT00046228|183104033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.809||95.0|0.74|1.27|||Chi-squared|||||1.27|0.74|0.809
91605250|NCT01056107|183104046|SUPERIORITY_OR_OTHER|||||||0.0075||95.0|||||Dunnett's test|||||||0.0075
91605251|NCT01056107|183104046|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's test|||||||<0.001
91605252|NCT03783195|183104054|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.59||0.4|TWO_SIDED|95.0|-1.77|0.76||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||0.76|-1.77|0.40
91605253|NCT03783195|183104055|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.93||0.71|TWO_SIDED|95.0|-3.33|2.57||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||2.57|-3.33|0.71
91605254|NCT03783195|183104056|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.02|STANDARD_ERROR_OF_MEAN|4.8||0.0006|TWO_SIDED|95.0|-31.33|-10.72||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.||-10.72|-31.33|0.0006
91605255|NCT03783195|183104057|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Median Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.17||0.59|TWO_SIDED|95.0|-0.27|0.46|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.||0.46|-0.27|0.59
91605256|NCT03783195|183104058|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.06|STANDARD_ERROR_OF_MEAN|7.77||0.017|TWO_SIDED|95.0|-37.75|-4.38||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.||-4.38|-37.75|0.017
91605257|NCT03783195|183104059|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.16||0.89|TWO_SIDED|95.0|-0.37|0.33|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.||0.33|-0.37|0.89
91605258|NCT03783195|183104060|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|4.62||0.36|TWO_SIDED|95.0|-14.28|5.55||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.||5.55|-14.28|0.36
91605259|NCT03783195|183104061|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.16||0.67|TWO_SIDED|95.0|-0.27|0.4|||t-test, 2 sided|||||0.40|-0.27|0.67
91605260|NCT03783195|183104062|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.03|STANDARD_ERROR_OF_MEAN|11.53||0.09|TWO_SIDED|95.0|-45.76|3.69||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.||3.69|-45.76|0.09
91605261|NCT03783195|183104063|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.13||0.69|TWO_SIDED|95.0|-0.24|0.34|||t-test, 2 sided|||||0.34|-0.24|0.69
91605262|NCT03783195|183104064|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-29.61|STANDARD_ERROR_OF_MEAN|15.28||0.07|TWO_SIDED|95.0|-62.39|3.17||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.||3.17|-62.39|0.07
91605263|NCT03783195|183104065|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.80
91605264|NCT03783195|183104066|OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.25||0.17|TWO_SIDED|95.0|-0.18|0.91||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.||0.91|-0.18|0.17
91605265|NCT03783195|183104067|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.217|STANDARD_ERROR_OF_MEAN|0.17||0.22|TWO_SIDED|95.0|-0.58|0.15|||t-test, 2 sided|||||0.15|-0.58|0.22
91605266|NCT03783195|183104068|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.007||0.04|TWO_SIDED|95.0|-0.03|-0.0009||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.||-0.0009|-0.03|0.04
91605267|NCT03783195|183104069|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.19||0.53|TWO_SIDED|95.0|-0.52|0.28|||t-test, 2 sided|||||0.28|-0.52|0.53
91605268|NCT03783195|183104070|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|20.57|STANDARD_ERROR_OF_MEAN|17.5||0.25|TWO_SIDED|95.0|-16.9|58.08||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.||58.08|-16.9|0.25
91605269|NCT03783195|183104071|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED|95.0|-0.59|0.13|||t-test, 2 sided|||||0.13|-0.59|0.20
91605270|NCT03783195|183104072|OTHER||Mean Difference (Net)|28.95|STANDARD_ERROR_OF_MEAN|21.78||0.21|TWO_SIDED|95.0|-17.76|75.67||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.||75.67|-17.76|0.21
91709596|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.51|
91709597|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.71|0.49|
91709598|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.50|
91709599|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.51|||||TWO_SIDED|95.0|0.4|0.64||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.64|0.40|
91709600|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.84||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.84|0.62|
91709601|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.69|||||TWO_SIDED|95.0|0.6|0.8||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.80|0.60|
91709602|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.01|0.70|
91790927|NCT02880956|183460087|SUPERIORITY||LS Mean of Difference|0.5|STANDARD_ERROR_OF_MEAN|0.696||0.475|TWO_SIDED|95.0|-0.872|1.867||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.867|-0.872|0.475
91605271|NCT03783195|183104073|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.12||0.67|TWO_SIDED|95.0|-0.214|0.321|||t-test, 2 sided|||||0.321|-0.214|0.67
91605272|NCT03783195|183104074|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.12|0.28||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.||0.28|-0.12|0.41
91605273|NCT03783195|183104075|OTHER|Both groups received the same intervention; however, their genetic make-up was different|Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.15||0.49|TWO_SIDED|95.0|-0.44|0.22|||t-test, 2 sided|||||0.22|-0.44|0.49
91709603|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.66|||||TWO_SIDED|95.0|0.57|0.77||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.77|0.57|
91709604|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.87||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.87|0.65|
91709605|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.85|0.67|
91790928|NCT02880956|183460087|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790929|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.427||0.926|TWO_SIDED|95.0|-0.799|0.878||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.878|-0.799|0.926
91605274|NCT00215150|183104076|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Signed Rank Test|||Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.||||< 0.001
91605275|NCT00215150|183104076|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.||||> .05
91651364|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0092|TWO_SIDED|95.0|-2.86|-0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.41|-2.86|0.0092
91651365|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0139|TWO_SIDED|95.0|-2.94|-0.33|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.33|-2.94|0.0139
91651366|NCT01360632|183194663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.0015|TWO_SIDED|95.0|-3.42|-0.81|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.81|-3.42|0.0015
91651367|NCT01360632|183194664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0008|TWO_SIDED|95.0|-0.87|-0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.23|-0.87|0.0008
91651368|NCT01360632|183194664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.5792|TWO_SIDED|95.0|-0.41|0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B||0.23|-0.41|0.5792
91651369|NCT01360632|183194664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0091|TWO_SIDED|95.0|-0.87|-0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.12|-0.87|0.0091
91651370|NCT01360632|183194664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0474|TWO_SIDED|95.0|-0.73|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.73|0.0474
91651371|NCT01360632|183194665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0015|TWO_SIDED|95.0|-0.94|-0.22||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.22|-0.94|0.0015
91651372|NCT01360632|183194665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.2627|TWO_SIDED|95.0|-0.56|0.15||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate|Mixed Models Analysis|||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.15|-0.56|0.2627
91651373|NCT01360632|183194665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0158|TWO_SIDED|95.0|-0.89|-0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3||-0.09|-0.89|0.0158
91651374|NCT01360632|183194665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0191|TWO_SIDED|95.0|-0.88|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.08|-0.88|0.0191
91605276|NCT02091440|183104091|OTHER|Single group|Proportion|100.0|||||TWO_SIDED|95.0||||||||||||
91605277|NCT02091440|183104092|OTHER|Single group|Kaplan-Meier Survival|100.0|||||TWO_SIDED|||||||||||||
91605278|NCT02091440|183104093|OTHER|Single group|Incidence|1.24|||||TWO_SIDED|||||||||||||
91605279|NCT02091440|183104094|OTHER|Single group|Incidence|1.66|||||TWO_SIDED|||||||||||||
91605280|NCT02091440|183104095|OTHER|Single group|Change from baseline|19.4|STANDARD_DEVIATION|11.39|||TWO_SIDED|95.0|7.5|31.4|||||Confidence interval based on t-distribution.|||31.4|7.5|
91605281|NCT02091440|183104096|OTHER|Single group|Percentage change|-83.33|||||TWO_SIDED||||||||Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%|||||
91651375|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0377|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||-0.03|-0.88|0.0377
91605282|NCT02091440|183104097|OTHER|Single group|Change from baseline|130.0|STANDARD_DEVIATION|275.32|||TWO_SIDED|95.0|-158.9|418.9|||||Confidence interval based on t-distribution.|||418.9|-158.9|
91605283|NCT03576144|183104099|OTHER||Slope|1.0474|STANDARD_ERROR_OF_MEAN|0.0283|||TWO_SIDED|90.0|0.9997|1.0951|||ANCOVA||Standard Error of the mean is actually standard error of slope.Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUC0-12 of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0951|0.9997|
91605284|NCT03576144|183104100|OTHER||Slope|1.0091|STANDARD_ERROR_OF_MEAN|0.038|||TWO_SIDED|90.0|0.9451|1.0732|||ANCOVA||Standard Error of the is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0732|0.9451|
91605285|NCT03576144|183104101|OTHER||Slope|1.052|STANDARD_ERROR_OF_MEAN|0.0325|||TWO_SIDED|90.0|0.9972|1.1069|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUCτ,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1069|0.9972|
91605286|NCT03576144|183104102|OTHER||Slope|1.0361|STANDARD_ERROR_OF_MEAN|0.0379|||TWO_SIDED|90.0|0.9722|1.1001|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1001|0.9722|
91605287|NCT05224258|183104124|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.2|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.1|-0.4|<0.001
91605288|NCT05224258|183104124|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint.|||-0.2|-0.5|<0.001
91605289|NCT05224258|183104125|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7|||<|0.001|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|<0.001
91605290|NCT05224258|183104125|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
91605291|NCT05224258|183104126|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.3|<0.001
91605292|NCT05224258|183104126|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.2|<0.001
91605293|NCT05224258|183104127|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7||||0.208|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|0.208
91605294|NCT05224258|183104127|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
91605295|NCT01381094|183104152|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|0.24|
91605296|NCT01381094|183104152|SUPERIORITY||Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.2|1.33||||||||1.33|0.20|
91605297|NCT01381094|183104152|SUPERIORITY||Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.73|1.83||||||||1.83|0.73|
91709606|NCT04530838|183311599|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.64|||||TWO_SIDED|95.0|0.53|0.78||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.78|0.53|
91709607|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|4.01|||||TWO_SIDED|95.0|3.36|4.79||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||4.79|3.36|
91651376|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0741|TWO_SIDED|95.0|-0.91|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis||-0.43|For Item: Work/School: Week 14||0.04|-0.91|0.0741
91651377|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.0966|TWO_SIDED|95.0|-0.07|0.81||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||For Item: Work/School: Week 11||0.81|-0.07|0.0966
91651378|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4774|TWO_SIDED|95.0|-0.66|0.31|||Mixed Models Analysis|||For Item: Work/School: Week 14||0.31|-0.66|0.4774
91651379|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0263|TWO_SIDED|95.0|-0.76|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.05|-0.76|0.0263
91651380|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0214|TWO_SIDED|95.0|-0.89|-0.07|||Mixed Models Analysis|||Social life: Week 14||-0.07|-0.89|0.0214
91787752|NCT03595618|183455331|SUPERIORITY||Adjusted mean difference|0.03779|STANDARD_ERROR_OF_MEAN|0.02156||0.193|TWO_SIDED|95.0|-0.00448|0.08005||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08005|-0.00448|0.193
91651381|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8281|TWO_SIDED|95.0|-0.4|0.32||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.32|-0.40|0.8281
91651382|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.054|TWO_SIDED|95.0|-0.8|0.01|||Mixed Models Analysis|||Social life: Week 14||0.01|-0.80|0.0540
91651383|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.0008|TWO_SIDED|95.0|-0.99|-0.26||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.26|-0.99|0.0008
91523414|NCT01987817|182922524|SUPERIORITY||Treatment difference|0.912|||<|0.0001|TWO_SIDED|95.0|0.5184|1.3065||The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption.|ANCOVA|Least squares means and 95% CIs based on ANCOVA model of change from baseline in MTD at Exit DBPCFC (terms for treatment \& MTD at baseline (log10 mg).||MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation.||1.3065|0.5184|<0.0001
91651384|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0093|TWO_SIDED|95.0|-0.97|-0.14|||Mixed Models Analysis|||Family life: Week 14||-0.14|-0.97|0.0093
91651385|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.2182|TWO_SIDED|95.0|-0.59|0.14|||Mixed Models Analysis|||Family life: Week 11||0.14|-0.59|0.2182
91651386|NCT01360632|183194666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0256|TWO_SIDED|95.0|-0.9|-0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.06|-0.90|0.0256
91651387|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0341|TWO_SIDED|95.0|-1.01|-0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||-0.04|-1.01|0.0341
91651388|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0816|TWO_SIDED|95.0|-0.99|0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||School/work: Week 14||0.06|-0.99|0.0816
91651389|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.2561|TWO_SIDED|95.0|-0.21|0.78||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||0.78|-0.21|0.2561
91651390|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2952|TWO_SIDED|95.0|-0.82|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 14||0.25|-0.82|0.2952
91651391|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0331|TWO_SIDED|95.0|-0.82|-0.03||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.03|-0.82|0.0331
91605298|NCT01381094|183104152|SUPERIORITY||Mean Difference (Net)|1.45|||||TWO_SIDED|95.0|0.91|2.0||||||||2.00|0.91|
91651392|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0352|TWO_SIDED|95.0|-0.9|-0.03|||Mixed Models Analysis|||Social life: Week 14||-0.03|-0.90|0.0352
91651393|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.486|TWO_SIDED|95.0|-0.54|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.25|-0.54|0.4860
91651394|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0282|TWO_SIDED|95.0|-0.93|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 14||-0.05|-0.93|0.0282
91651395|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0016|TWO_SIDED|95.0|-1.01|-0.24||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.24|-1.01|0.0016
91651396|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0186|TWO_SIDED|95.0|-0.94|-0.09|||Mixed Models Analysis|||Family life: Week 14||-0.09|-0.94|0.0186
91651397|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0824|TWO_SIDED|95.0|-0.73|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||0.04|-0.73|0.0824
91651398|NCT01360632|183194667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.0077|TWO_SIDED|95.0|-1.02|-0.16||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.16|-1.02|0.0077
91651399|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.0436|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.18|0.0436
91651400|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||-0.06|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.03|-0.15|-0.06
91651401|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0012|TWO_SIDED|95.0|-0.34|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.08|-0.34|0.0012
91651402|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0266|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.02|-0.27|0.0266
91605299|NCT01381094|183104152|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
91605300|NCT01381094|183104153|SUPERIORITY||||||=|0.9355|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9355
91790930|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790931|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.423||0.553|TWO_SIDED|95.0|-1.082|0.58||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.580|-1.082|0.553
91790932|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|3.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790933|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.432||0.69|TWO_SIDED|95.0|-1.021|0.677||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.677|-1.021|0.690
91790934|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91605301|NCT01381094|183104153|SUPERIORITY||||||=|0.6594|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6594
91790935|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|0.499||0.073|TWO_SIDED|95.0|-0.085|1.879||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.879|-0.085|0.073
91790936|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91651403|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0034|TWO_SIDED|95.0|-0.33|-0.07|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.07|-0.33|0.0034
91651404|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.3053|TWO_SIDED|95.0|-0.2|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.2|0.3053
91651405|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0541|TWO_SIDED|95.0|-0.29|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.29|0.0541
91651406|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0912|TWO_SIDED|95.0|-0.28|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.28|0.0912
91651407|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1553|TWO_SIDED|95.0|-0.28|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.04|-0.28|0.1553
91651408|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1855|TWO_SIDED|95.0|-0.27|0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.05|-0.27|0.1855
91651409|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.2015|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.28|0.2015
91651410|NCT01360632|183194668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0852|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.32|0.0852
91787753|NCT03595618|183455331|SUPERIORITY||Adjusted mean difference|0.0358|STANDARD_ERROR_OF_MEAN|0.02235||0.256|TWO_SIDED|95.0|-0.00801|0.07962||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.07962|-0.00801|0.256
91651411|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.0817|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.17|0.0817
91651412|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.1406|TWO_SIDED|95.0|-0.16|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.16|0.1406
91790937|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.487||0.517|TWO_SIDED|95.0|-0.641|1.273||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 48||1.273|-0.641|0.517
91790938|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790939|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.38|STANDARD_ERROR_OF_MEAN|0.501||0.454|TWO_SIDED|95.0|-0.609|1.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.360|-0.609|0.454
91787754|NCT03595618|183455331|SUPERIORITY||Adjusted mean difference|0.03884|STANDARD_ERROR_OF_MEAN|0.02243||0.201|TWO_SIDED|95.0|-0.00514|0.08281||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08281|-0.00514|0.201
91790940|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.45|||TWO_SIDED|||||||||Week 48||||
91605302|NCT01381094|183104153|SUPERIORITY||||||=|0.0203|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0203
91605303|NCT01381094|183104153|SUPERIORITY||||||=|0.0369|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0369
91605304|NCT01381094|183104153|SUPERIORITY|p-value was based on the comparison within treatment group (Change from Baseline to Week 1).|||||=|0.3713|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.3713
91605305|NCT01381094|183104153|SUPERIORITY||||||=|0.163|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1630
91605306|NCT01381094|183104153|SUPERIORITY||||||=|0.7615|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7615
91605307|NCT01381094|183104153|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0040
91605308|NCT01381094|183104153|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0003
91605309|NCT01381094|183104153|SUPERIORITY||||||=|0.3978|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3978
91605310|NCT01381094|183104153|SUPERIORITY||||||=|0.0083|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0083
91605311|NCT01381094|183104153|SUPERIORITY||||||=|0.0323|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0323
91605312|NCT01381094|183104153|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0003
91605313|NCT01381094|183104153|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0001
91605314|NCT01381094|183104153|SUPERIORITY||||||=|0.423|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4230
91605315|NCT01381094|183104153|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0023
91651413|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.011|TWO_SIDED|95.0|-0.29|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-0.29|0.011
91790941|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.57|STANDARD_ERROR_OF_MEAN|0.522||0.276|TWO_SIDED|95.0|-0.456|1.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.596|-0.456|0.276
91790942|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91605316|NCT01381094|183104153|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0009
91605317|NCT01381094|183104153|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91787755|NCT03595618|183455332|SUPERIORITY||Adjusted mean difference|3.12394|STANDARD_ERROR_OF_MEAN|3.13671||0.627|TWO_SIDED|95.0|-3.02464|9.27252||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||9.27252|-3.02464|0.627
91787756|NCT03595618|183455332|SUPERIORITY||Adjusted mean difference|0.46842|STANDARD_ERROR_OF_MEAN|3.21111||0.998|TWO_SIDED|95.0|-5.82659|6.76343||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||6.76343|-5.82659|0.998
91787757|NCT03595618|183455332|SUPERIORITY||Adjusted mean difference|4.11756|STANDARD_ERROR_OF_MEAN|3.2759||0.449|TWO_SIDED|95.0|-2.30536|10.54049||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||10.54049|-2.30536|0.449
91787758|NCT03595618|183455333|SUPERIORITY||Adjusted mean difference|2.84781|STANDARD_ERROR_OF_MEAN|3.75674||0.789|TWO_SIDED|95.0|-4.51643|10.21205||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||10.21205|-4.51643|0.789
91787759|NCT03595618|183455333|SUPERIORITY||Adjusted mean difference|-3.64759|STANDARD_ERROR_OF_MEAN|3.84747||0.661|TWO_SIDED|95.0|-11.19071|3.89553||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.89553|-11.19071|0.661
91787760|NCT03595618|183455333|SUPERIORITY||Adjusted mean difference|-2.55176|STANDARD_ERROR_OF_MEAN|3.81987||0.843|TWO_SIDED|95.0|-10.04053|4.93701||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||4.93701|-10.04053|0.843
91605318|NCT01381094|183104153|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91790943|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.516||0.935|TWO_SIDED|95.0|-0.973|1.058||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.058|-0.973|0.935
91790944|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790945|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.523||0.942|TWO_SIDED|95.0|-0.99|1.066||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-0.990|0.942
91605319|NCT01381094|183104153|SUPERIORITY||||||=|0.5291|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5291
91605320|NCT01381094|183104153|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
91605321|NCT01381094|183104153|SUPERIORITY||||||=|0.0222|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0222
91787761|NCT03595618|183455334|SUPERIORITY||Adjusted mean difference|0.0951|STANDARD_ERROR_OF_MEAN|0.0499||0.141|TWO_SIDED|95.0|-0.0028|0.1929||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1929|-0.0028|0.141
91605322|NCT01381094|183104153|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
91651414|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0287|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.02|-0.27|0.0287
91651415|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0071|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.05|-0.32|0.0071
91651416|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.2503|TWO_SIDED|95.0|-0.22|-0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.06|-0.22|0.2503
91651417|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0539|TWO_SIDED|95.0|-0.3|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-0.3|0.0539
91651418|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0398|TWO_SIDED|95.0|-0.31|-0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.01|-0.31|0.0398
91787762|NCT03595618|183455334|SUPERIORITY||Adjusted mean difference|0.0158|STANDARD_ERROR_OF_MEAN|0.0519||0.981|TWO_SIDED|95.0|-0.0861|0.1177||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1177|-0.0861|0.981
91787763|NCT03595618|183455334|SUPERIORITY||Adjusted mean difference|0.0753|STANDARD_ERROR_OF_MEAN|0.0529||0.349|TWO_SIDED|95.0|-0.0286|0.1792||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1792|-0.0286|0.349
91651419|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.1168|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.03|-0.3|0.1168
91651420|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0621|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.32|0.0621
91651421|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.089|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.32|0.089
91787764|NCT02279407|183455338|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.83||||0.046|TWO_SIDED|95.0|0.7|1.0||Hypotheses tested using Dunnett's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons versus a single control (placebo).|Mixed Models Analysis|||||1.00|0.70|0.046
91605323|NCT01381094|183104153|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
91605324|NCT01381094|183104153|SUPERIORITY||||||=|0.9314|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9314
91605325|NCT01381094|183104154|SUPERIORITY||||||=|0.5219|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5219
91605326|NCT01381094|183104154|SUPERIORITY||||||=|0.6743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6743
91605327|NCT01381094|183104154|SUPERIORITY||||||=|0.0078|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0078
91605328|NCT01381094|183104154|SUPERIORITY||||||=|0.0301|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0301
91651422|NCT01360632|183194669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0213|TWO_SIDED|95.0|-0.38|-0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.03|-0.38|0.0213
91651423|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0228|TWO_SIDED|95.0|-2.37|-0.18|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.18|-2.37|0.0228
91651424|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.5081|TWO_SIDED|95.0|-1.47|0.73|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.73|-1.47|0.5081
91651425|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0064|TWO_SIDED|95.0|-3.2|-0.53|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.53|-3.2|0.0064
91523415|NCT00916032|182922557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.103
91605329|NCT01381094|183104154|SUPERIORITY||||||=|0.4502|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.4502
91605330|NCT01381094|183104154|SUPERIORITY||||||=|0.6967|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6967
91605331|NCT01381094|183104154|SUPERIORITY||||||=|0.7385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7385
91605332|NCT01381094|183104154|SUPERIORITY||||||=|0.0176|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0176
91605333|NCT01381094|183104154|SUPERIORITY||||||=|0.0057|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0057
91605334|NCT01381094|183104154|SUPERIORITY||||||=|0.5551|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5551
91605335|NCT01381094|183104154|SUPERIORITY||||||=|0.0086|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0086
91605336|NCT01381094|183104154|SUPERIORITY||||||=|0.2385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2385
91605337|NCT01381094|183104154|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0007
91605338|NCT01381094|183104154|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0002
91605339|NCT01381094|183104154|SUPERIORITY||||||=|0.8895|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8895
91605340|NCT01381094|183104154|SUPERIORITY||||||=|0.0127|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0127
91605341|NCT01381094|183104154|SUPERIORITY||||||=|0.0076|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0076
91651426|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.1898|TWO_SIDED|95.0|-2.23|0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.44|-2.23|0.1898
91651427|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09||||0.0074|TWO_SIDED|95.0|-3.62|-0.56|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.56|-3.62|0.0074
91787765|NCT02279407|183455339|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.502|TWO_SIDED|95.0|0.75|1.11||Conditional upon rejection of at least 1 of the 3 hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.11|0.75|0.502
91787766|NCT02279407|183455339|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.562|TWO_SIDED|95.0|0.73|1.13||Conditional upon rejection of at least 1 of the hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.13|0.73|0.562
91790946|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91605342|NCT01381094|183104154|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0007
91605343|NCT01381094|183104154|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605344|NCT01381094|183104154|SUPERIORITY||||||=|0.5522|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5522
91605345|NCT01381094|183104154|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0031
91605346|NCT01381094|183104154|SUPERIORITY||||||=|0.2188|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2188
91605347|NCT01381094|183104154|SUPERIORITY||||||=|0.0054|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0054
91605348|NCT01381094|183104154|SUPERIORITY||||||=|0.0037|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0037
91605349|NCT01381094|183104154|SUPERIORITY||||||=|0.9521|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9521
91605350|NCT01381094|183104155|SUPERIORITY||||||=|0.3943|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.3943
91605351|NCT01381094|183104155|SUPERIORITY||||||=|0.2096|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.2096
91605352|NCT01381094|183104155|SUPERIORITY||||||=|0.0637|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0637
91605353|NCT01381094|183104155|SUPERIORITY||||||=|0.5016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5016
91605354|NCT01381094|183104155|SUPERIORITY||||||=|0.7549|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.7549
91651428|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.5935|TWO_SIDED|95.0|-1.95|1.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||1.11|-1.95|0.5935
91651429|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0211|TWO_SIDED|95.0|-3.52|-0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.29|-3.52|0.0211
91651430|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.1031|TWO_SIDED|95.0|-2.96|0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.27|-2.96|0.1031
91787767|NCT00422084|183455340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 5% non-inferiority margin. Non-inferiority was demonstrated if the lower limit of the CI for the difference \>-5%.|ACPR percent difference|0.3||||0.578|TWO_SIDED|95.0|-0.7|1.8||If non-inferiority of PA is demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to AL is statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than -5%."||1.8|-0.7|0.578
91787768|NCT01323855|183455358|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio (GMR) is contained within the interval \[0.50, 2.00\]|GMR|1.19|||||TWO_SIDED|90.0|0.54|2.62|||||Severe CRI/Healthy|||2.62|0.54|
91523416|NCT00916032|182922558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.162
91605355|NCT01381094|183104155|SUPERIORITY||||||=|0.5991|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5991
91605356|NCT01381094|183104155|SUPERIORITY||||||=|0.4258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4258
91605357|NCT01381094|183104155|SUPERIORITY||||||=|0.0336|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0336
91605358|NCT01381094|183104155|SUPERIORITY||||||=|0.0258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0258
91605359|NCT01381094|183104155|SUPERIORITY||||||=|0.2412|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.2412
91605360|NCT01381094|183104155|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0031
91605361|NCT01381094|183104155|SUPERIORITY||||||=|0.7705|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7705
91787769|NCT01323855|183455359|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|1.3|||||TWO_SIDED|90.0|0.59|2.87|||||Moderate CRI/Healthy|||2.87|0.59|
91605362|NCT01381094|183104155|SUPERIORITY||||||=|0.0024|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0024
91605363|NCT01381094|183104155|SUPERIORITY||||||=|0.0006|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0006
91605364|NCT01381094|183104155|SUPERIORITY||||||=|0.6189|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6189
91651431|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1366||||0.1366|TWO_SIDED|95.0|-3.02|0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.41|-3.02|0.1366
91651432|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.2709|TWO_SIDED|95.0|-2.68|0.75|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.75|-2.68|0.2709
91651433|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.0812|TWO_SIDED|95.0|-3.4|0.2|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.2|-3.4|0.0812
91651434|NCT01360632|183194670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.1001|TWO_SIDED|95.0|-3.33|0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.29|-3.33|0.1001
91651435|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0496|TWO_SIDED|95.0|-2.24|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-2.24|0.0496
91787770|NCT01323855|183455360|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|2.63|||||TWO_SIDED|90.0|1.38|5.04|||||Mild CRI/Healthy|||5.04|1.38|
91787771|NCT03996369|183455361|SUPERIORITY||Risk Difference (RD)|9.69|||=|0.026|TWO_SIDED|95.0|1.14|18.23|||Cochran-Mantel-Haenszel|||Week 12||18.23|1.14|=0.026
91787772|NCT03996369|183455362|SUPERIORITY||Risk Difference (RD)|12.11|||=|0.009|TWO_SIDED|95.0|3.0|21.23|||Cochran-Mantel-Haenszel|||Week 12||21.23|3.00|=0.009
91787773|NCT03996369|183455363|SUPERIORITY||Risk Difference (RD)|17.48|||=|0.001|TWO_SIDED|95.0|6.81|28.15|||Cochran-Mantel-Haenszel|||Week 12||28.15|6.81|=0.001
91787774|NCT03996369|183455364|SUPERIORITY||Risk Difference (RD)|7.44|||=|0.036|TWO_SIDED|95.0|0.5|14.39|||Cochran-Mantel-Haenszel|||Week 12||14.39|0.50|=0.036
91787775|NCT03996369|183455365|SUPERIORITY||Risk Difference (RD)|21.23|||<|0.001|TWO_SIDED|95.0|10.18|32.29|||Cochran-Mantel-Haenszel|||Week 12||32.29|10.18|<0.001
91787776|NCT03996369|183455366|SUPERIORITY||Risk Difference (RD)|9.24|||=|0.009|TWO_SIDED|95.0|2.27|16.2|||Cochran-Mantel-Haenszel|||Week 12||16.20|2.27|=0.009
91605365|NCT01381094|183104155|SUPERIORITY||||||=|0.0075|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0075
91605366|NCT01381094|183104155|SUPERIORITY||||||=|0.0259|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0259
91605367|NCT01381094|183104155|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605368|NCT01381094|183104155|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605369|NCT01381094|183104155|SUPERIORITY||||||=|0.8898|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8898
91787777|NCT03996369|183455367|SUPERIORITY||Risk Difference (RD)|5.85|||=|0.115|TWO_SIDED|95.0|-1.42|13.13|||Cochran-Mantel-Haenszel|||Week 2||13.13|-1.42|=0.115
91787778|NCT03996369|183455367|SUPERIORITY||Risk Difference (RD)|11.83|||=|0.007|TWO_SIDED|95.0|3.19|20.47|||Cochran-Mantel-Haenszel|||Week 4||20.47|3.19|=0.007
91787779|NCT03996369|183455367|SUPERIORITY||Risk Difference (RD)|14.84|||=|0.003|TWO_SIDED|95.0|4.98|24.69|||Cochran-Mantel-Haenszel|||Week 8||24.69|4.98|=0.003
91787780|NCT03996369|183455368|SUPERIORITY||Risk Difference (RD)|2.83|||=|0.128|TWO_SIDED|95.0|-0.81|6.48|||Cochran-Mantel-Haenszel|||Week 2||6.48|-0.81|=0.128
91787781|NCT03996369|183455368|SUPERIORITY||Risk Difference (RD)|8.32|||=|0.002|TWO_SIDED|95.0|3.01|13.64|||Cochran-Mantel-Haenszel|||Week 4||13.64|3.01|=0.002
91787782|NCT03996369|183455368|SUPERIORITY||Risk Difference (RD)|7.06|||=|0.032|TWO_SIDED|95.0|0.62|13.49|||Cochran-Mantel-Haenszel|||Week 8||13.49|0.62|=0.032
91787783|NCT03996369|183455368|SUPERIORITY||Risk Difference (RD)|9.18|||=|0.014|TWO_SIDED|95.0|1.82|16.54|||Cochran-Mantel-Haenszel|||Week 12||16.54|1.82|=0.014
91787784|NCT03996369|183455369|SUPERIORITY||Risk Difference (RD)|15.55|||=|0.002|TWO_SIDED|95.0|5.65|25.46|||Cochran-Mantel-Haenszel|||Week 2||25.46|5.65|=0.002
91605370|NCT01381094|183104155|SUPERIORITY||||||=|0.001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0010
91605371|NCT01381094|183104155|SUPERIORITY||||||=|0.2864|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2864
91605372|NCT01381094|183104155|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
91605373|NCT01381094|183104155|SUPERIORITY||||||=|0.0016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0016
91605374|NCT01381094|183104155|SUPERIORITY||||||=|0.9697|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9697
91605375|NCT01381094|183104156|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=1.0000
91605376|NCT01381094|183104156|SUPERIORITY||||||=|0.0055|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0055
91605377|NCT01381094|183104156|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0009
91605378|NCT01381094|183104156|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0002
91605379|NCT01381094|183104156|SUPERIORITY||||||=|0.9722|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9722
91605380|NCT01381094|183104156|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=1.0000
91605381|NCT01381094|183104156|SUPERIORITY||||||=|0.0008|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0008
91605382|NCT01381094|183104156|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0002
91605383|NCT01381094|183104156|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
91605384|NCT01381094|183104156|SUPERIORITY||||||=|0.6579|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6579
91605385|NCT01381094|183104156|SUPERIORITY||||||=|0.4102|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4102
91605386|NCT01381094|183104156|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0023
91605387|NCT01381094|183104156|SUPERIORITY||||||=|0.0052|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0052
91651436|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.387|TWO_SIDED|95.0|-1.61|0.63|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.63|-1.61|0.387
91651437|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0125|TWO_SIDED|95.0|-3.13|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.38|-3.13|0.0125
91787785|NCT03996369|183455369|SUPERIORITY||Risk Difference (RD)|14.98|||=|0.007|TWO_SIDED|95.0|4.05|25.91|||Cochran-Mantel-Haenszel|||Week 4||25.91|4.05|=0.007
91787786|NCT03996369|183455369|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.95|33.25|||Cochran-Mantel-Haenszel|||Week 8||33.25|11.95|<0.001
91787787|NCT03996369|183455369|SUPERIORITY||Risk Difference (RD)|17.58|||=|0.002|TWO_SIDED|95.0|6.7|28.47|||Cochran-Mantel-Haenszel|||Week 12||28.47|6.70|=0.002
91787788|NCT03996369|183455370|SUPERIORITY||Risk Difference (RD)|15.99|||=|0.002|TWO_SIDED|95.0|6.07|25.91|||Cochran-Mantel-Haenszel|||Week 2||25.91|6.07|=0.002
91787789|NCT03996369|183455370|SUPERIORITY||Risk Difference (RD)|15.45|||=|0.006|TWO_SIDED|95.0|4.54|26.36|||Cochran-Mantel-Haenszel|||Week 4||26.36|4.54|=0.006
91787790|NCT03996369|183455370|SUPERIORITY||Risk Difference (RD)|22.14|||<|0.001|TWO_SIDED|95.0|11.43|32.85|||Cochran-Mantel-Haenszel|||Week 8||32.85|11.43|<0.001
91651438|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0898|TWO_SIDED|95.0|-2.57|0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.19|-2.57|0.0898
91787791|NCT03996369|183455370|SUPERIORITY||Risk Difference (RD)|18.49|||<|0.001|TWO_SIDED|95.0|7.65|29.33|||Cochran-Mantel-Haenszel|||Week 12||29.33|7.65|<0.001
91651439|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.004|TWO_SIDED|95.0|-3.88|-0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.74|-3.88|0.004
91787792|NCT00653432|183455373|SUPERIORITY|||||||0.145|||||||Ordinal GEE Model|||||||0.1450
91787793|NCT00653432|183455374|SUPERIORITY|||||||0.5824|||||||Ordinal GEE Model|||||||0.5824
91787794|NCT00653432|183455375|SUPERIORITY|||||||0.9136|||||||Ordinal GEE Model|||||||0.9136
91787795|NCT00653432|183455376|SUPERIORITY|||||||0.1699|||||||Ordinal GEE Model|||||||0.1699
91787796|NCT00653432|183455377|SUPERIORITY|||||||0.3238|||||||Ordinal GEE Model|||||||0.3238
91787797|NCT00653432|183455378|SUPERIORITY|||||||0.0427|||||||Ordinal GEE Model|||||||0.0427
91787798|NCT00653432|183455379|SUPERIORITY|||||||0.8206|||||||Ordinal GEE Model|||||||0.8206
91787799|NCT00653432|183455380|SUPERIORITY|||||||0.9818|||||||Ordinal GEE Model|||||||0.9818
91787800|NCT00653432|183455381|SUPERIORITY|||||||0.0542|||||||Ordinal GEE Model|||||||0.0542
91787801|NCT00653432|183455382|SUPERIORITY|||||||0.323|||||||Ordinal GEE Model|||||||0.3230
91787802|NCT01782469|183455384|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
91787803|NCT01782469|183455384|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
91787804|NCT01782469|183455384|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||<0.001
91787805|NCT01782469|183455384|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
91787806|NCT01782469|183455385|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||.130
91787807|NCT01782469|183455385|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.031
91787808|NCT01782469|183455385|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.006
91787809|NCT01782469|183455385|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.003
91787810|NCT00600119|183455404|SUPERIORITY_OR_OTHER|||||||0.7781|||||||Wilcoxon (Mann-Whitney)|||||||0.7781
91787811|NCT00600119|183455404|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.0020
91787812|NCT00600119|183455404|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91787813|NCT00600119|183455405|SUPERIORITY_OR_OTHER|||||||0.5118|||||||Wilcoxon (Mann-Whitney)|||||||0.5118
91787814|NCT00600119|183455405|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||||||0.0022
91787815|NCT00600119|183455405|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91787816|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.5522||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5522
91787817|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.0589||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0589
91651440|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.301|TWO_SIDED|95.0|-2.4|0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.74|-2.4|0.301
91787818|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.1691||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1691
91605388|NCT01381094|183104156|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0017
91651441|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.0118|TWO_SIDED|95.0|-3.82|-0.48|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.48|-3.82|0.0118
91651442|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.0287|TWO_SIDED|95.0|-3.54|-0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.19|-3.54|0.0287
91787819|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.6293||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6293
91605389|NCT01381094|183104156|SUPERIORITY||||||=|0.7378|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7378
91787820|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.0836||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0836
91605390|NCT01381094|183104156|SUPERIORITY||||||=|0.3371|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3371
91787821|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.1155||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1155
91787822|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.9938||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9938
91787823|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.2101||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.2101
91787824|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.4597||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4597
91787825|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.4822||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4822
91787826|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.0171||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0171
91787827|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.016||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0160
91787828|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.6857||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6857
91787829|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.0253||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0253
91787830|NCT00600119|183455406|SUPERIORITY_OR_OTHER|||||||0.0772||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0772
91787831|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.5008||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5008
91787832|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.1823||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1823
91787833|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.7045||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7045
91787834|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.7088||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7088
91787835|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.5828||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5828
91787836|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.0116||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0116
91787837|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.7848||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7848
91787838|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.0335||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0335
91787839|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.0591||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0591
91787840|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.9317||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9317
91651443|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0686|TWO_SIDED|95.0|-3.39|0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.12|-3.39|0.0686
91787841|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.0675||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0675
91787842|NCT00600119|183455407|SUPERIORITY_OR_OTHER|||||||0.1745||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1745
91787843|NCT04740905|183455408|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.2|1.1|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.1|-2.2|
91787844|NCT04740905|183455408|SUPERIORITY||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4978|TWO_SIDED|95.0|-2.2|1.1||Tested at a two-sided 0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept.||1.1|-2.2|0.4978
91787845|NCT04740905|183455410|OTHER||Difference in CMH Weighted Percentage|-4.3|||||TWO_SIDED|95.0|-12.3|3.8||||||||3.8|-12.3|
91787846|NCT04740905|183455426|OTHER||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||||||||1.1|-1.9|
91787847|NCT00561977|183455456|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Mixed Models Analysis|time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.||Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).||||0.14
91787848|NCT01960907|183455480|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|||||||0.342
91651444|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.056|TWO_SIDED|95.0|-3.47|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.04|-3.47|0.056
91651445|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0448|TWO_SIDED|95.0|-3.75|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-3.75|0.0448
91651446|NCT01360632|183194671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.0251|TWO_SIDED|95.0|-3.98|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.27|-3.98|0.0251
91651447|NCT01360632|183194672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.1732|TWO_SIDED|95.0|-1.63|0.29|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||0.29|-1.63|0.1732
91651448|NCT01360632|183194672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0066|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||-0.37|-2.31|0.0066
91787849|NCT01960907|183455481|SUPERIORITY_OR_OTHER|||||||0.915|||||||t-test, 2 sided|||||||0.915
91787850|NCT01960907|183455482|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
91787851|NCT00993226|183455493|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_DEVIATION|0.29||0.467|TWO_SIDED|95.0|-0.79|0.36|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.36|-0.79|0.467
91787852|NCT00993226|183455494|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_DEVIATION|2.57||0.331|TWO_SIDED|95.0|-7.59|2.58|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||2.58|-7.59|0.331
91787853|NCT00791817|183455499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3897|||||TWO_SIDED|90.0|1.1998|1.6097||||Confidence Interval is on the Ratio of Fed to Fasted|Confidence Interval is on the Ratio of Fed to Fasted|values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted||1.6097|1.1998|
91787854|NCT00796926|183455568|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
91790947|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.569||0.578|TWO_SIDED|95.0|-0.802|1.436||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.436|-0.802|0.578
91790948|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91605391|NCT01381094|183104156|SUPERIORITY||||||=|0.0916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0916
91605392|NCT01381094|183104156|SUPERIORITY||||||=|0.4656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4656
91605393|NCT01381094|183104156|SUPERIORITY||||||=|0.1629|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1629
91787855|NCT00006289|183455581|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
91605394|NCT01381094|183104156|SUPERIORITY||||||=|0.7032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.7032
91605395|NCT01381094|183104156|SUPERIORITY||||||=|0.5194|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5194
91605396|NCT01381094|183104156|SUPERIORITY||||||=|0.8516|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8516
91605397|NCT01381094|183104156|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0017
91605398|NCT01381094|183104156|SUPERIORITY||||||=|0.0656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0656
91787856|NCT00006289|183455582|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
91787857|NCT00006289|183455583|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
91787858|NCT00678743|183455622|SUPERIORITY|All statistical significance were completed at the 5% level, two-tailed. Comparability of baseline characteristics between those who did and did not opt to enter the extension study was assessed with the chi square test and analysis of variance.||||||0.0008||||||Threshold for statistical significance p\<0.05|ANOVA|||||||0.0008
91787859|NCT00576420|183455626|SUPERIORITY_OR_OTHER|||||||0.1564||90.0|||||Likelihood ratio chi-square test|||||||0.1564
91787860|NCT00576420|183455628|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Likelihood ratio chi-square test|||||||0.060
91787861|NCT00576420|183455628|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Likelihood ratio chi-square test|||||||0.005
91787862|NCT00576420|183455629|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||Likelihood ratio chi-square test|||||||0.123
91787863|NCT00576420|183455629|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Likelihood ratio chi-square test|||||||0.026
91787864|NCT00576420|183455630|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Likelihood ratio chi-square test|||||||0.929
91787865|NCT00576420|183455630|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Likelihood ratio chi-square test|||||||0.228
91787866|NCT00576420|183455632|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Likelihood ratio chi-square test|||||||0.234
91787867|NCT00576420|183455632|SUPERIORITY_OR_OTHER|||||||0.955||95.0|||||Likelihood ratio chi-square test|||||||0.955
91787868|NCT00576420|183455633|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||Likelihood ratio chi-square test|||||||0.106
91787869|NCT00576420|183455633|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Likelihood ratio chi-square test|||||||0.243
91787870|NCT00576420|183455633|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
91787871|NCT00576420|183455634|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Likelihood ratio chi-square test|||||||0.257
91787872|NCT00576420|183455634|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||Likelihood ratio chi-square test|||||||0.096
91787873|NCT00576420|183455634|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
91787874|NCT01221272|183455657|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.67||||0.29|TWO_SIDED|95.0|-0.6|1.9||The null hypothesis that ranolazine treatment had no effect on PDS would be rejected if the PDS and TPD p-values were less than 0.05 or the PDS p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.9|-0.6|0.29
91787875|NCT01221272|183455658|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.65||||0.22|TWO_SIDED|95.0|-0.4|1.7||The null hypothesis that ranolazine treatment had no effect on TPD would be rejected if the PDS and TPD p-values were less than 0.05 or the TPD p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.7|-0.4|0.22
91787876|NCT01340872|183455662|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
91787877|NCT01340872|183455666|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
91605399|NCT01381094|183104156|SUPERIORITY||||||=|0.6495|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6495
91605400|NCT01381094|183104157|SUPERIORITY||||||=|0.2065|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.2065
91651449|NCT01360632|183194673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1226|TWO_SIDED|95.0|-1.78|0.21|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.21|-1.78|0.1226
91651450|NCT01360632|183194673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.001|TWO_SIDED|95.0|-2.69|-0.68|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.68|-2.69|0.001
91651451|NCT01360632|183194674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8164|TWO_SIDED|95.0|-0.93|0.73|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.73|-0.93|0.8164
91651452|NCT01360632|183194674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1939|TWO_SIDED|95.0|-1.39|0.28|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.28|-1.39|0.1939
91651453|NCT01360632|183194675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.5192|TWO_SIDED|95.0|-1.14|0.57|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.57|-1.14|0.5192
91651454|NCT01360632|183194675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0443|TWO_SIDED|95.0|-1.75|-0.02|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.02|-1.75|0.0443
91651455|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0248|TWO_SIDED|95.0|-0.26|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.26|0.0248
91651456|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1334|TWO_SIDED|95.0|-0.22|0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.03|-0.22|0.1334
91651457|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
91787878|NCT01340872|183455667|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43||||ANCOVA|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|||1.43|< 0.0001
91787879|NCT01340872|183455678|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
91605401|NCT01381094|183104157|SUPERIORITY||||||=|0.1807|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.1807
91605402|NCT01381094|183104157|SUPERIORITY||||||=|0.7869|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.7869
91605403|NCT01381094|183104157|SUPERIORITY||||||=|0.4743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.4743
91787880|NCT01340872|183455679|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
91605404|NCT01381094|183104157|SUPERIORITY||||||=|0.6407|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.6407
91605405|NCT01381094|183104158|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91651458|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0019|TWO_SIDED|95.0|-0.38|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.09|-0.38|0.0019
91651459|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
91605406|NCT01381094|183104158|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
91605407|NCT01381094|183104158|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91787881|NCT01502332|183455691|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91787882|NCT01502332|183455692|SUPERIORITY_OR_OTHER|||||||0.014|||||||Log Rank|||||||0.014
91787883|NCT01502332|183455693|SUPERIORITY_OR_OTHER|||||||0.037|||||||Log Rank|||||||0.037
91605408|NCT01381094|183104158|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605409|NCT01381094|183104158|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605410|NCT01381094|183104159|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
91605411|NCT01381094|183104159|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0004
91605412|NCT01381094|183104159|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
91605413|NCT01381094|183104159|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605414|NCT01381094|183104159|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
91605415|NCT01381094|183104160|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605416|NCT01381094|183104160|SUPERIORITY||||||=|0.0043|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0043
91605417|NCT01381094|183104160|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91787884|NCT01502332|183455695|SUPERIORITY_OR_OTHER|||||||0.267|||||||Regression, Logistic|||||||0.267
91787885|NCT03039621|183455696|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance equals 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
91787886|NCT03039621|183455697|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
91787887|NCT03039621|183455698|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
91787888|NCT03039621|183455699|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
91605418|NCT01381094|183104160|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605419|NCT01381094|183104160|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
91605420|NCT01381094|183104161|SUPERIORITY||||||=|0.0027|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0027
91605421|NCT01381094|183104161|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605422|NCT01381094|183104161|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
91605423|NCT01381094|183104161|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
91605424|NCT01381094|183104161|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0005
91605425|NCT01381094|183104167|SUPERIORITY||||||=|0.6051|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6051
91605426|NCT01381094|183104167|SUPERIORITY||||||=|0.5197|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5197
91605427|NCT01381094|183104167|SUPERIORITY||||||=|0.1073|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1073
91605428|NCT01381094|183104167|SUPERIORITY||||||=|0.1321|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1321
91605429|NCT01381094|183104167|SUPERIORITY||||||=|0.4358|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4358
91605430|NCT01381094|183104167|SUPERIORITY||||||=|0.8109|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8109
91605431|NCT01381094|183104167|SUPERIORITY||||||=|0.2575|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2575
91605432|NCT01381094|183104167|SUPERIORITY||||||=|0.8361|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8361
91651460|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0254|TWO_SIDED|95.0|-0.34|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.34|0.0254
91605433|NCT01381094|183104167|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0294
91787889|NCT03039621|183455700|SUPERIORITY|||||||0.0201||||||"The p-value associated with treatment factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0201
91787890|NCT03039621|183455701|SUPERIORITY|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
91787891|NCT03039621|183455702|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
91787892|NCT03039621|183455702|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.22|||||||Breslow-Day test|||||||0.22
91787893|NCT03039621|183455703|SUPERIORITY|||||||0.0037||||||"The p-value associated with treatment factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0037
91787894|NCT03039621|183455704|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
91787895|NCT02522624|183455705|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
91605434|NCT01381094|183104167|SUPERIORITY||||||=|0.8809|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8809
91605435|NCT01381094|183104167|SUPERIORITY||||||=|0.4971|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4971
91605436|NCT01381094|183104167|SUPERIORITY||||||=|0.3994|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3994
91605437|NCT01381094|183104167|SUPERIORITY||||||=|0.5022|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5022
91605438|NCT01381094|183104167|SUPERIORITY||||||=|0.9916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.9916
91605439|NCT01381094|183104167|SUPERIORITY||||||=|0.2292|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.2292
91605440|NCT01381094|183104167|SUPERIORITY||||||=|0.1331|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1331
91605441|NCT01381094|183104167|SUPERIORITY||||||=|0.5518|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5518
91605442|NCT01381094|183104167|SUPERIORITY||||||=|0.9032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9032
91605443|NCT01381094|183104167|SUPERIORITY||||||=|0.2387|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2387
91605444|NCT01381094|183104167|SUPERIORITY||||||=|0.4251|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.4251
91605445|NCT01381094|183104168|SUPERIORITY||||||=|0.0448|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0448
91605446|NCT01381094|183104168|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
91605447|NCT01381094|183104168|SUPERIORITY||||||=|0.0813|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0813
91605448|NCT01381094|183104168|SUPERIORITY||||||=|0.0038|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0038
91605449|NCT01381094|183104168|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6861
91605450|NCT01381094|183104168|SUPERIORITY||||||=|0.0553|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0553
91605451|NCT01381094|183104168|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0004
91605452|NCT01381094|183104168|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
91605453|NCT01381094|183104168|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
91605454|NCT01381094|183104168|SUPERIORITY||||||=|0.7379|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7379
91605455|NCT01381094|183104168|SUPERIORITY||||||=|0.072|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0720
91605456|NCT01381094|183104168|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
91605457|NCT01381094|183104168|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605458|NCT01381094|183104168|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605459|NCT01381094|183104168|SUPERIORITY||||||=|0.6781|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.6781
91605460|NCT01381094|183104168|SUPERIORITY||||||=|0.0524|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0524
91605461|NCT01381094|183104168|SUPERIORITY||||||=|0.0367|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0367
91605462|NCT01381094|183104168|SUPERIORITY||||||=|0.6671|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6671
91605463|NCT01381094|183104168|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6861
91651461|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0035|TWO_SIDED|95.0|-0.41|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.41|0.0035
91605464|NCT01381094|183104168|SUPERIORITY||||||=|0.9012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9012
91605465|NCT01381094|183104169|SUPERIORITY||||||=|0.3953|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3953
91605466|NCT01381094|183104169|SUPERIORITY||||||=|0.085|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0850
91605467|NCT01381094|183104169|SUPERIORITY||||||=|0.6045|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6045
91605468|NCT01381094|183104169|SUPERIORITY||||||=|0.7743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7743
91605469|NCT01381094|183104169|SUPERIORITY||||||=|0.5326|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5326
91651462|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0152|TWO_SIDED|95.0|-0.39|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.04|-0.39|0.0152
91651463|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.004|TWO_SIDED|95.0|-0.42|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.42|0.004
91651464|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.013|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.05|-0.42|0.013
91651465|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0755|TWO_SIDED|95.0|-0.33|0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.02|-0.33|0.0755
91651466|NCT01360632|183194676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0527|TWO_SIDED|95.0|-0.39|0.0|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0|-0.39|0.0527
91651467|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0275|TWO_SIDED|95.0|-0.26|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.01|-0.26|0.0275
91651468|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1583|TWO_SIDED|95.0|-0.22|0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.04|-0.22|0.1583
91651469|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0021|TWO_SIDED|95.0|-0.41|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.41|0.0021
91651470|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0018|TWO_SIDED|95.0|-0.4|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.4|0.0018
91787896|NCT02522624|183455705|SUPERIORITY_OR_OTHER|||||||0.16||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.16
91651471|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0011|TWO_SIDED|95.0|-0.43|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.11|-0.43|0.0011
91651472|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0235|TWO_SIDED|95.0|-0.36|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.36|0.0235
91787897|NCT02522624|183455705|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Controlling for Numeracy.||||<.001
91787898|NCT02522624|183455706|SUPERIORITY_OR_OTHER|||||||0.002||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||0.002
91787899|NCT02522624|183455706|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.30
91787900|NCT02522624|183455706|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Controlling for Numeracy.||||0.82
91651473|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0021|TWO_SIDED|95.0|-0.44|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.10|-0.44|0.0021
91651474|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0111|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.05|-0.42|0.0111
91651475|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.44|0.0030
91651476|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0046|TWO_SIDED|95.0|-0.47|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.47|0.0046
91651477|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0237|TWO_SIDED|95.0|-0.39|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.39|0.0237
91651478|NCT01360632|183194677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0171|TWO_SIDED|95.0|-0.45|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.04|-0.45|0.0171
91651479|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.5279|TWO_SIDED|95.0|0.51|3.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.68|0.51|0.5279
91651480|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
91651481|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.92||||0.0484|TWO_SIDED|95.0|0.99|3.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.72|0.99|0.0484
91651482|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.5813|TWO_SIDED|95.0|0.6|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|0.60|0.5813
91651483|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.1236|TWO_SIDED|95.0|0.9|2.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.54|0.90|0.1236
91787901|NCT02522624|183455707|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
91651484|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.4998|TWO_SIDED|95.0|0.7|2.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.10|0.70|0.4998
91787902|NCT02522624|183455707|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.82
91787903|NCT02522624|183455707|SUPERIORITY_OR_OTHER|||||||0.15|||||||Regression, Linear|||Controlling for Numeracy.||||0.15
91787904|NCT02522624|183455708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1|TWO_SIDED|95.0|0.92|2.36||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||2.36|0.92|0.10
91787905|NCT02522624|183455708|SUPERIORITY_OR_OTHER|||||||0.26|||||||Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.26
91787906|NCT02522624|183455708|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Linear|||Controlling for Numeracy.||||0.58
91651485|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.64||||0.0365|TWO_SIDED|95.0|1.03|2.61|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.61|1.03|0.0365
91651486|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.52||||0.0822|TWO_SIDED|95.0|0.95|2.43|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.43|0.95|0.0822
91651487|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.4049|TWO_SIDED|95.0|0.79|1.78|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.78|0.79|0.4049
91651488|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.2951|TWO_SIDED|95.0|0.84|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.80|0.84|0.2951
91651489|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.53||||0.0248|TWO_SIDED|95.0|1.06|2.2|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.20|1.06|0.0248
91651490|NCT01360632|183194678|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0326|TWO_SIDED|95.0|1.03|2.21|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.21|1.03|0.0326
91651491|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|0.87||||0.7993|TWO_SIDED|95.0|0.3|2.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.55|0.30|0.7993
91651492|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
91787907|NCT02522624|183455709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52|||<|0.001|TWO_SIDED|95.0|1.58|4.01||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||4.01|1.58|<.001
91651493|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.2825|TWO_SIDED|95.0|0.71|3.16|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.16|0.71|0.2825
91651494|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.2||||0.6375|TWO_SIDED|95.0|0.58|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|0.58|0.6375
91651495|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.0923|TWO_SIDED|95.0|0.92|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.92|0.0923
91651496|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.29||||0.3812|TWO_SIDED|95.0|0.73|2.3|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.30|0.73|0.3812
91787908|NCT02522624|183455709|SUPERIORITY_OR_OTHER|||||||0.39||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.39
91787909|NCT02522624|183455709|SUPERIORITY_OR_OTHER|||||||0.57|||||||Regression, Linear|||Controlling for Numeracy.||||0.57
91787910|NCT02522624|183455710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.32|||<|0.001|TWO_SIDED|95.0|5.94|17.95||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||17.95|5.94|<.001
91605470|NCT01381094|183104169|SUPERIORITY||||||=|0.3465|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.3465
91787911|NCT02522624|183455710|SUPERIORITY_OR_OTHER|||||||0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.001
91605471|NCT01381094|183104169|SUPERIORITY||||||=|0.2756|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2756
91605472|NCT01381094|183104169|SUPERIORITY||||||=|0.1414|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1414
91605473|NCT01381094|183104169|SUPERIORITY||||||=|0.6941|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6941
91605474|NCT01381094|183104169|SUPERIORITY||||||=|0.9403|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.9403
91605475|NCT01381094|183104169|SUPERIORITY||||||=|0.831|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8310
91605476|NCT01381094|183104169|SUPERIORITY||||||=|0.0654|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0654
91605477|NCT01381094|183104169|SUPERIORITY||||||=|0.4169|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4169
91605478|NCT01381094|183104169|SUPERIORITY||||||=|0.0103|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0103
91605479|NCT01381094|183104169|SUPERIORITY||||||=|0.3968|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3968
91605480|NCT01381094|183104169|SUPERIORITY||||||=|0.0325|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0325
91605481|NCT01381094|183104169|SUPERIORITY||||||=|0.2151|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2151
91787912|NCT02522624|183455710|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||Controlling for numeracy.||||0.46
91605482|NCT01381094|183104169|SUPERIORITY||||||=|0.8436|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8436
91605483|NCT01381094|183104169|SUPERIORITY||||||=|0.5962|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5962
91605484|NCT01381094|183104169|SUPERIORITY||||||=|0.3957|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.3957
91605485|NCT01381094|183104170|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0294
91605486|NCT01381094|183104170|SUPERIORITY||||||=|0.0021|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0021
91605487|NCT01381094|183104170|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
91523417|NCT05559866|182922602|OTHER|Variance|Mean Difference (Final Values)|0.53|||<|0.01|TWO_SIDED|95.0|0.31|0.74|||t-test, 2 sided|||Scores from the proximal stomach, mid-stomach and distal stomach in the control and treatment groups were analyzed to determine if there was a significant difference between the mean difference in durability scores for the control and treatment groups.||.74|.31|<0.01
91651497|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.63||||0.0464|TWO_SIDED|95.0|1.0|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.65|1.00|0.0464
91787913|NCT00362180|183455718|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 26.||||0.7244
91523418|NCT05559866|182922603|OTHER|Variance|Mean Difference (Final Values)|19.125|STANDARD_ERROR_OF_MEAN|0.0000013||1|TWO_SIDED|95.0|19.125|19.125|||ANCOVA|||||19.125|19.125|1.00
91651498|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.049|TWO_SIDED|95.0|1.0|2.64|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.64|1.00|0.0490
91651499|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.32||||0.2124|TWO_SIDED|95.0|0.85|2.06|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.06|0.85|0.2124
91651500|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.1078|TWO_SIDED|95.0|0.93|2.14|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.14|0.93|0.1078
91651501|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.69||||0.0094|TWO_SIDED|95.0|1.14|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.14|0.0094
91651502|NCT01360632|183194679|SUPERIORITY_OR_OTHER||Ratio of response rate|1.65||||0.0162|TWO_SIDED|95.0|1.09|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.09|0.0162
91651503|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of remission rate|1.03||||0.9498|TWO_SIDED|95.0|0.37|2.9|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.90|0.37|0.9498
91651504|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
91651505|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|0.93||||0.8609|TWO_SIDED|95.0|0.4|2.17|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.17|0.40|0.8609
91651506|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.2846|TWO_SIDED|95.0|0.22|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.22|0.2846
91651507|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.248|TWO_SIDED|95.0|0.75|2.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.99|0.75|0.2480
91651508|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.13||||0.7513|TWO_SIDED|95.0|0.54|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.37|0.54|0.7513
91787914|NCT00362180|183455718|SUPERIORITY_OR_OTHER|||||||0.0513|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 99.||||0.0513
91787915|NCT03930264|183455725|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for tablet and suspension were required to be within the 80 to 125% range.|Odds Ratio (OR)|1.12||||0.3008|TWO_SIDED|90.0|0.93|1.35|||ANOVA|||||1.35|0.93|0.3008
91787916|NCT03930264|183455726|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-τ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.06||||0.1061|TWO_SIDED|90.0|1.0|1.13|||ANOVA|||||1.13|1.00|0.1061
91787917|NCT03930264|183455727|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-∞ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.02||||0.5696|TWO_SIDED|90.0|0.96|1.09|||ANOVA|||||1.09|0.96|0.5696
91605488|NCT01381094|183104170|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0001
91605489|NCT01381094|183104170|SUPERIORITY||||||=|0.0925|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0925
91605490|NCT01381094|183104170|SUPERIORITY||||||=|0.0433|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0433
91651509|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.82||||0.0554|TWO_SIDED|95.0|0.99|3.35|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.35|0.99|0.0554
91651510|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2409|TWO_SIDED|95.0|0.76|2.87|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.87|0.76|0.2409
91651511|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.5538|TWO_SIDED|95.0|0.69|2.02|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.02|0.69|0.5538
91651512|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.44||||0.1743|TWO_SIDED|95.0|0.85|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.41|0.85|0.1743
91651513|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.3||||0.2843|TWO_SIDED|95.0|0.81|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.07|0.81|0.2843
91651514|NCT01360632|183194680|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.464|TWO_SIDED|95.0|0.74|1.92|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.92|0.74|0.4640
91709608|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.76|0.48|
91605491|NCT01381094|183104170|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
91651515|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3867|TWO_SIDED|95.0|0.18|1.97|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.97|0.18|0.3867
91651516|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
91651517|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.32|TWO_SIDED|95.0|0.21|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.66|0.21|0.3200
91787918|NCT02600871|183455728|SUPERIORITY|The significance of variation in proportions with treatment (Provodine®, Control) was assessed with Fisher's Exact tests and variation in the mean with treatment was assessed with T-tests.||||||0.71|||||||Fisher Exact|||||||0.71
91787919|NCT00789074|183455751|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
91787920|NCT00789074|183455752|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
91787921|NCT00789074|183455753|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||F=16.60|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
91787922|NCT00789074|183455754|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||F=2.92|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.04
91605492|NCT01381094|183104170|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0005
91605493|NCT01381094|183104170|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
91605494|NCT01381094|183104170|SUPERIORITY||||||=|0.1626|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1626
91605495|NCT01381094|183104170|SUPERIORITY||||||=|0.0366|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0366
91605496|NCT01381094|183104170|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0004
91605497|NCT01381094|183104170|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0012
91605498|NCT01381094|183104170|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605499|NCT01381094|183104170|SUPERIORITY||||||=|0.1779|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1779
91605500|NCT01381094|183104170|SUPERIORITY||||||=|0.5867|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5867
91605501|NCT01381094|183104170|SUPERIORITY||||||=|0.1306|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1306
91605502|NCT01381094|183104170|SUPERIORITY||||||=|0.9889|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9889
91605503|NCT01381094|183104170|SUPERIORITY||||||=|0.2026|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2026
91651518|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3266|TWO_SIDED|95.0|0.23|1.62|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.62|0.23|0.3266
91651519|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.47||||0.3027|TWO_SIDED|95.0|0.7|3.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.10|0.70|0.3027
91651520|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.17||||0.696|TWO_SIDED|95.0|0.54|2.52|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.52|0.54|0.6960
91787923|NCT00789074|183455755|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.02
91787924|NCT00789074|183455756|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.97
91787925|NCT01350544|183455798|SUPERIORITY||Odds Ratio (OR)|0.79||||0.005|TWO_SIDED|95.0|0.69|0.91||a priori threshold for significance for p \< .05|Mixed Models Analysis|||We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.||0.91|0.69|.005
91787926|NCT00594425|183455808|SUPERIORITY_OR_OTHER||% success rate|5.53||||0.5288|TWO_SIDED|95.0|-7.97|19.04||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||19.04|-7.97|0.5288
91787927|NCT00594425|183455808|SUPERIORITY_OR_OTHER||% success rate|3.95||||0.7539|TWO_SIDED|95.0|-8.79|16.69||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||16.69|-8.79|0.7539
91605504|NCT01381094|183104170|SUPERIORITY||||||=|0.5703|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5703
91605505|NCT01381094|183104171|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
91605506|NCT01381094|183104171|SUPERIORITY||||||=|0.0092|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0092
91605507|NCT01381094|183104171|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0012
91605508|NCT01381094|183104171|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
91605509|NCT01381094|183104171|SUPERIORITY||||||=|0.1157|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1157
91605510|NCT01381094|183104171|SUPERIORITY||||||=|0.0069|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0069
91605511|NCT01381094|183104171|SUPERIORITY||||||=|0.0034|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0034
91605512|NCT01381094|183104171|SUPERIORITY||||||=|0.0067|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0067
91605513|NCT01381094|183104171|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
91605514|NCT01381094|183104171|SUPERIORITY||||||=|0.0401|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0401
91605515|NCT01381094|183104171|SUPERIORITY||||||=|0.0042|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0042
91605516|NCT01381094|183104171|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605517|NCT01381094|183104171|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
91605518|NCT01381094|183104171|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
91605519|NCT01381094|183104171|SUPERIORITY||||||=|0.0422|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0422
91605520|NCT01381094|183104171|SUPERIORITY||||||=|0.0232|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0232
91523419|NCT05559866|182922604|OTHER|Variance||||||0.757||||||alpha = 0.05|ANCOVA|1 degree of freedom||||||0.757
91605521|NCT01381094|183104171|SUPERIORITY||||||=|0.0243|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0243
91605522|NCT01381094|183104171|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0001
91605523|NCT01381094|183104171|SUPERIORITY||||||=|0.1089|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1089
91605524|NCT01381094|183104171|SUPERIORITY||||||=|0.0833|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0833
91605525|NCT01381094|183104173|SUPERIORITY||||||=|0.5456|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.5456
91605526|NCT01381094|183104173|SUPERIORITY||||||=|0.0053|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0053
91787928|NCT00594425|183455809|SUPERIORITY_OR_OTHER||Least squares mean|-2.64||||0.3236|TWO_SIDED|95.0|-7.91|2.63||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||2.63|-7.91|0.3236
91605527|NCT01381094|183104173|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||<0.0001
91605528|NCT01381094|183104173|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0040
91605529|NCT01381094|183104173|SUPERIORITY||||||=|0.2017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.2017
91605530|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.562|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.357|0.885||||||Comparison at 6 h post first dose||0.885|0.357|
91605531|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.612|STANDARD_ERROR_OF_MEAN|0.281|||TWO_SIDED|95.0|0.349|1.072||||||Comparison at 12 h post first dose||1.072|0.349|
91605532|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.518|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|0.274|0.981||||||Comparison at 18 h post first dose||0.981|0.274|
91787929|NCT00594425|183455809|SUPERIORITY_OR_OTHER||Least squares mean|-1.19||||0.6657|TWO_SIDED|95.0|-6.64|4.26||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||4.26|-6.64|0.6657
91605533|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.416|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.217|0.796||||||Comparison at 24 h post first dose||0.796|0.217|
91605534|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.517|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|0.262|1.021||||||Comparison at 48 h post first dose||1.021|0.262|
91605535|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.661|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|0.291|1.503||||||Comparison at 72 h post first dose||1.503|0.291|
91605536|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.908|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|0.366|2.254||||||Comparison at 96 h post first dose||2.254|0.366|
91605537|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.195|||TWO_SIDED|95.0|0.52|1.134||||||Comparison at 6 h post first dose||1.134|0.520|
91605538|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.701|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|0.427|1.15||||||Comparison at 12 h post first dose||1.150|0.427|
91605539|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.578|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.329|1.015||||||Comparison at 18 h post first dose||1.015|0.329|
91605540|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.41|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.231|0.728||||||Comparison at 24 h post first dose||0.728|0.231|
91605541|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.896|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.484|1.657||||||Comparison at 48 h post first dose||1.657|0.484|
91605542|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.739|STANDARD_ERROR_OF_MEAN|0.374|||TWO_SIDED|95.0|0.35|1.563||||||Comparison at 72 h post first dose||1.563|0.350|
91605543|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.56|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|0.659|3.697||||||Comparison at 96 h post first dose||3.697|0.659|
91605544|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.608|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.433|0.853||||||Comparison at 6 h post first dose||0.853|0.433|
91605545|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.674|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|95.0|0.437|1.039||||||Comparison at 12 h post first dose||1.039|0.437|
91605546|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.613|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|0.374|1.004||||||Comparison at 18 h post first dose||1.004|0.374|
91605547|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.558|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.338|0.921||||||Comparison at 24 h post first dose||0.921|0.338|
91605548|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|95.0|0.427|1.23||||||Comparison at 48 h post first dose||1.230|0.427|
91605549|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.73|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.384|1.386||||||Comparison at 72 h post first dose||1.386|0.384|
91605550|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.147|STANDARD_ERROR_OF_MEAN|0.359|||TWO_SIDED|95.0|0.559|2.353||||||Comparison at 96 h post first dose||2.353|0.559|
91605551|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.776|STANDARD_ERROR_OF_MEAN|0.167|||TWO_SIDED|95.0|0.556|1.082||||||Comparison at 6 h post first dose||1.082|0.556|
91787930|NCT00594425|183455837|SUPERIORITY_OR_OTHER||%success rate|3.09||||0.7889|TWO_SIDED|95.0|-11.16|17.33||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||17.33|-11.16|0.7889
91523420|NCT05559866|182922605|OTHER|Variance||||||0.271||||||Alpha = 0.05|ANCOVA|1 degree of freedom||||||0.271
91605552|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.602|STANDARD_ERROR_OF_MEAN|0.212|||TWO_SIDED|95.0|0.394|0.919||||||Comparison at 12 h post first dose||0.919|0.394|
91605553|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.623|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|0.386|1.007||||||Comparison at 18 h post first dose||1.007|0.386|
91605554|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.429|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|0.263|0.7||||||Comparison at 24 h post first dose||0.700|0.263|
91605555|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.502|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|0.299|0.842||||||Comparison at 48 h post first dose||0.842|0.299|
91605556|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.479|STANDARD_ERROR_OF_MEAN|0.317|||TWO_SIDED|95.0|0.255|0.903||||||Comparison at 72 h post first dose||0.903|0.255|
91605557|NCT00996840|183104249|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.579|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|95.0|0.281|1.192||||||Comparison at 96 h post first dose||1.192|0.281|
91605558|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.484|STANDARD_ERROR_OF_MEAN|0.219|||TWO_SIDED|95.0|0.312|0.75||||||Comparison at 6 h post first dose||0.750|0.312|
91605559|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.399|1.229||||||Comparison at 12 h post first dose||1.229|0.399|
91605560|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.681|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|0.37|1.254||||||Comparison at 18 h post first dose||1.254|0.370|
91787931|NCT00594425|183455837|SUPERIORITY_OR_OTHER||Percent success|5.48||||0.888|TWO_SIDED|95.0|-10.15|21.11||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||21.11|-10.15|0.8880
91787932|NCT00594425|183455838|SUPERIORITY_OR_OTHER||Least squares mean|-0.33||||0.9151|TWO_SIDED|95.0|-6.53|5.86||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.86|-6.53|0.9151
91605561|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.673|STANDARD_ERROR_OF_MEAN|0.302|||TWO_SIDED|95.0|0.368|1.231||||||Comparison at 24 h post first dose||1.231|0.368|
91605562|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.92|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.456|1.857||||||Comparison at 48 h post first dose||1.857|0.456|
91605563|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.944|STANDARD_ERROR_OF_MEAN|0.376|||TWO_SIDED|95.0|0.445|2.002||||||Comparison at 72 h post first dose||2.002|0.445|
91605564|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.905|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.476|1.723||||||Comparison at 96 h post first dose||1.723|0.476|
91605565|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.726|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|95.0|0.488|1.08||||||Comparison at 6 h post first dose||1.080|0.488|
91605566|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.791|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.476|1.317||||||Comparison at 12 h post first dose||1.317|0.476|
91651521|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.1368|TWO_SIDED|95.0|0.86|3.07||CMH general association test controlling for trial site|Cochran-Mantel-Haenszel|||Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.07|0.86|0.1368
91651522|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2387|TWO_SIDED|95.0|0.76|2.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.89|0.76|0.2387
91651523|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.26||||0.4498|TWO_SIDED|95.0|0.69|2.28|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.28|0.69|0.4498
91651524|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.6||||0.1009|TWO_SIDED|95.0|0.91|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.91|0.1009
91651525|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.45||||0.1499|TWO_SIDED|95.0|0.87|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.41|0.87|0.1499
91605567|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|0.417|1.26||||||Comparison at 18 h post first dose||1.260|0.417|
91605568|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.655|STANDARD_ERROR_OF_MEAN|0.273|||TWO_SIDED|95.0|0.379|1.13||||||Comparison at 24 h post first dose||1.130|0.379|
91605569|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.111|STANDARD_ERROR_OF_MEAN|0.323|||TWO_SIDED|95.0|0.583|2.12||||||Comparison at 48 h post first dose||2.120|0.583|
91605570|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.075|STANDARD_ERROR_OF_MEAN|0.346|||TWO_SIDED|95.0|0.539|2.146||||||Comparison at 72 h post first dose||2.146|0.539|
91605571|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.375|STANDARD_ERROR_OF_MEAN|0.313|||TWO_SIDED|95.0|0.735|2.574||||||Comparison at 96 h post first dose||2.574|0.735|
91605572|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.559|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.4|0.783||||||Comparison at 6 h post first dose||0.783|0.400|
91651526|NCT01360632|183194681|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3012|TWO_SIDED|95.0|0.78|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.18|0.78|0.3012
91651527|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.2873|TWO_SIDED|95.0|0.75|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.65|0.75|0.2873
91651528|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.2677|TWO_SIDED|95.0|0.79|2.36|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.36|0.79|0.2677
91523421|NCT05559866|182922606|OTHER|Variance||||||0.29||||||alpha = 0.05|ANCOVA|1 degree of freedom||||||0.29
91605573|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.83|STANDARD_ERROR_OF_MEAN|0.216|||TWO_SIDED|95.0|0.539|1.277||||||Comparison at 12 h post first dose||1.277|0.539|
91605574|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.987|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|95.0|0.613|1.589||||||Comparison at 18 h post first dose||1.589|0.613|
91605575|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.924|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|0.582|1.467||||||Comparison at 24 h post first dose||1.467|0.582|
91605576|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.23|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|0.716|2.11||||||Comparison at 48 h post first dose||2.110|0.716|
91605577|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.289|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|0.719|2.312||||||Comparison at 72 h post first dose||2.312|0.719|
91605578|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.752|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|95.0|1.053|2.916||||||Comparison at 96 h post first dose||2.916|1.053|
91605579|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.163|||TWO_SIDED|95.0|0.419|0.803||||||Comparison at 6 h post first dose||0.803|0.419|
91605580|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|0.433|0.996||||||Comparison at 12 h post first dose||0.996|0.433|
91651529|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.8||||0.0031|TWO_SIDED|95.0|1.21|2.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.68|1.21|0.0031
91651530|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.7||||0.0066|TWO_SIDED|95.0|1.15|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|1.15|0.0066
91787933|NCT00594425|183455838|SUPERIORITY_OR_OTHER||Least squares mean|-1.18||||0.7233|TWO_SIDED|95.0|-7.81|5.45||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.45|-7.81|0.7233
91605581|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.747|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|0.477|1.171||||||Comparison at 18 h post first dose||1.171|0.477|
91605582|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.421|1.024||||||Comparison at 24 h post first dose||1.024|0.421|
91651531|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.34||||0.0665|TWO_SIDED|95.0|0.98|1.83|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.83|0.98|0.0665
91651532|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.025|TWO_SIDED|95.0|1.05|1.91|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.91|1.05|0.0250
91651533|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.2224|TWO_SIDED|95.0|0.9|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.90|0.2224
91651534|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.0369|TWO_SIDED|95.0|1.01|1.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.68|1.01|0.0369
91651535|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.36||||0.0179|TWO_SIDED|95.0|1.05|1.75|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.75|1.05|0.0179
91651536|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.49||||0.0011|TWO_SIDED|95.0|1.17|1.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.89|1.17|0.0011
91651537|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.12||||0.3249|TWO_SIDED|95.0|0.89|1.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.41|0.89|0.3249
91787934|NCT02871882|183455870|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91523422|NCT05559866|182922607|OTHER|Variance||||||0.72||||||alpha = 0.05|ANCOVA|1 degree of freedom||||||0.72
91605583|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.759|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|0.451|1.279||||||Comparison at 48 h post first dose||1.279|0.451|
91605584|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.55|1.701||||||Comparison at 72 h post first dose||1.701|0.550|
91605585|NCT00996840|183104250|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.744|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.45|1.229||||||Comparison at 96 h post first dose||1.229|0.450|
91605586|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.773|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.607|0.985||||||Comparison at 6 h post first dose||0.985|0.607|
91605587|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.795|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|95.0|0.583|1.084||||||Comparison at 12 h post first dose||1.084|0.583|
91605588|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.778|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|0.533|1.135||||||Comparison at 18 h post first dose||1.135|0.533|
91605589|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.633|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|95.0|0.43|0.931||||||Comparison at 24 h post first dose||0.931|0.430|
91605590|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.662|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.397|1.103||||||Comparison at 48 h post first dose||1.103|0.397|
91605591|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.465|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|95.0|0.286|0.756||||||Comparison at 72 h post first dose||0.756|0.286|
91605592|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.525|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.295|0.935||||||Comparison at 96 h post first dose||0.935|0.295|
91605593|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.952|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.768|1.18||||||Comparison at 6 h post first dose||1.180|0.768|
91605594|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.965|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.733|1.269||||||Comparison at 12 h post first dose||1.269|0.733|
91605595|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.992|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.71|1.387||||||Comparison at 18 h post first dose||1.387|0.710|
91605596|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.913|STANDARD_ERROR_OF_MEAN|0.171|||TWO_SIDED|95.0|0.649|1.285||||||Comparison at 24 h post first dose||1.285|0.649|
91651538|NCT01360632|183194682|SUPERIORITY_OR_OTHER||Ratio of response rate|1.33||||0.0122|TWO_SIDED|95.0|1.06|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.66|1.06|0.0122
91651539|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.5836|TWO_SIDED|95.0|0.6|2.49|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.49|0.60|0.5836
91651540|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3792|TWO_SIDED|95.0|0.73|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.37|0.73|0.3792
91605597|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.66|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|95.0|0.415|1.051||||||Comparison at 48 h post first dose||1.051|0.415|
91605598|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.69|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.445|1.072||||||Comparison at 72 h post first dose||1.072|0.445|
91605599|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.724|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|0.423|1.239||||||Comparison at 96 h post first dose||1.239|0.423|
91605600|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|0.789|1.144||||||Comparison at 6 h post first dose||1.144|0.789|
91605601|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.985|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|0.777|1.249||||||Comparison at 12 h post first dose||1.249|0.777|
91605602|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.067|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.797|1.428||||||Comparison at 18 h post first dose||1.428|0.797|
91605603|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.922|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|0.686|1.239||||||Comparison at 24 h post first dose||1.239|0.686|
91523423|NCT05559866|182922608|OTHER|Variance||||||0.41||||||alpha = 0.05|ANCOVA|1 degree of freedom||||||0.41
91605604|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.866|STANDARD_ERROR_OF_MEAN|0.198|||TWO_SIDED|95.0|0.583|1.287||||||Comparison at 48 h post first dose||1.287|0.583|
91605605|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.649|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.444|0.95||||||Comparison at 72 h post first dose||0.950|0.444|
91605606|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.722|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.457|1.14||||||Comparison at 96 h post first dose||1.140|0.457|
91605607|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.897|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|95.0|0.748|1.075||||||Comparison at 6 h post first dose||1.075|0.748|
91605608|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.887|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.703|1.119||||||Comparison at 12 h post first dose||1.119|0.703|
91605609|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.846|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|0.638|1.123||||||Comparison at 18 h post first dose||1.123|0.638|
91605610|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.812|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|0.609|1.084||||||Comparison at 24 h post first dose||1.084|0.609|
91605611|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|95.0|0.394|0.855||||||Comparison at 48 h post first dose||0.855|0.394|
91605612|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.439|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|95.0|0.301|0.639||||||Comparison at 72 h post first dose||0.639|0.301|
91605613|NCT00996840|183104251|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.451|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.285|0.714||||||Comparison at 96 h post first dose||0.714|0.285|
91605614|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.85|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.646|1.119||||||Comparison at 6 h post first dose||1.119|0.646|
91605615|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.072|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|95.0|0.814|1.411||||||Comparison at 12 h post first dose||1.411|0.814|
91605616|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.08|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|95.0|0.79|1.478||||||Comparison at 18 h post first dose||1.478|0.790|
91605617|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.951|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|0.715|1.266||||||Comparison at 24 h post first dose||1.266|0.715|
91605618|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.918|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.655|1.285||||||Comparison at 48 h post first dose||1.285|0.655|
91605619|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.012|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.735|1.395||||||Comparison at 72 h post first dose||1.395|0.735|
91605620|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.168|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|95.0|0.831|1.64||||||Comparison at 96 h post first dose||1.640|0.831|
91651541|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.77||||0.0101|TWO_SIDED|95.0|1.14|2.74|||Ratio of response rate|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.74|1.14|0.0101
91651542|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.75||||0.0065|TWO_SIDED|95.0|1.17|2.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.63|1.17|0.0065
91651543|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.0526|TWO_SIDED|95.0|1.0|1.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.99|1.00|0.0526
91605621|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.912|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|95.0|0.713|1.167||||||Comparison at 6 h post first dose||1.167|0.713|
91605622|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.963|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.753|1.233||||||Comparison at 12 h post first dose||1.233|0.753|
91605623|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.917|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.693|1.214||||||Comparison at 18 h post first dose||1.214|0.693|
91605624|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.87|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|0.673|1.123||||||Comparison at 24 h post first dose||1.123|0.673|
91605625|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.141|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|95.0|0.84|1.55||||||Comparison at 48 h post first dose||1.550|0.840|
91605626|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.122|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.837|1.505||||||Comparison at 72 h post first dose||1.505|0.837|
91605627|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.474|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.063|2.045||||||Comparison at 96 h post first dose||2.045|1.063|
91605628|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.833|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.672|1.031||||||Comparison at 6 h post first dose||1.031|0.672|
91605629|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.879|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.707|1.092||||||Comparison at 12 h post first dose||1.092|0.707|
91605630|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.023|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.8|1.307||||||Comparison at 18 h post first dose||1.307|0.800|
91605631|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.111|||TWO_SIDED|95.0|0.761|1.187||||||Comparison at 24 h post first dose||1.187|0.761|
91605632|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|0.743|1.262||||||Comparison at 48 h post first dose||1.262|0.743|
91605633|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.926|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|95.0|0.718|1.193||||||Comparison at 72 h post first dose||1.193|0.718|
91605634|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.229|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|0.936|1.613||||||Comparison at 96 h post first dose||1.613|0.936|
91605635|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.923|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|0.753|1.131||||||Comparison at 6 h post first dose||1.131|0.753|
91605636|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|95.0|0.625|0.943||||||Comparison at 12 h post first dose||0.943|0.625|
91605637|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.826|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.655|1.042||||||Comparison at 18 h post first dose||1.042|0.655|
91605638|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.761|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|95.0|0.615|0.942||||||Comparison at 24 h post first dose||0.942|0.615|
91605639|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.781|STANDARD_ERROR_OF_MEAN|0.125|||TWO_SIDED|95.0|0.608|1.003||||||Comparison at 48 h post first dose||1.003|0.608|
91605640|NCT00996840|183104252|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.668|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.524|0.851||||||Comparison at 72 h post first dose||0.851|0.524|
91605641|NCT00996840|183104252|OTHER||Ratio (Treatment/Placebo)|0.86|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.659|1.122||||||Comparison at 96 h post first dose||1.122|0.659|
91790949|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|0.56|STANDARD_ERROR_OF_MEAN|0.34||0.545|TWO_SIDED|95.0|-0.762|1.441||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.441|-0.762|0.545
91790950|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790951|NCT02880956|183460088|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.583||0.346|TWO_SIDED|95.0|-1.697|0.597||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.597|-1.697|0.346
91605642|NCT00775021|183104284|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2334|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|95.0|-0.03501|0.2334|||Mixed Models Analysis||The mean difference is calculated as etafilconA minus nelfilcon A. Analysis is adjusted for lens type, period, lens type by period interaction, gender, lens type by gender interaction as fixed effects, subject nested within site as random effect.|The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.||0.2334|-0.03501|
91605643|NCT00775021|183104285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.07768|||TWO_SIDED|98.7|-0.108|0.06501|||Mixed Models Analysis||Mean difference calculated etafilcon A minus nelfilcon A. Analysis adjusted for lens type, period, lens by period interaction, gender, lens by gender interaction as fixed effects, subject nested within site and eye within subject as random effect.|The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.||0.06501|-0.1080|
91605644|NCT00775021|183104286|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.4001|STANDARD_ERROR_OF_MEAN|0.1799|||TWO_SIDED|98.7|-0.0055|0.4001|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.||0.4001|-0.0055|
91605645|NCT00775021|183104287|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|-0.1088|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|98.7|-0.5016|-0.1088|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.||-0.1088|-0.5016|
91651544|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0156|TWO_SIDED|95.0|1.08|2.11|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.11|1.08|0.0156
91651545|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.1689|TWO_SIDED|95.0|0.92|1.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.63|0.92|0.1689
91651546|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.0231|TWO_SIDED|95.0|1.04|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.80|1.04|0.0231
91651547|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.4||||0.0175|TWO_SIDED|95.0|1.06|1.84|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.84|1.06|0.0175
91651548|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.59||||0.0004|TWO_SIDED|95.0|1.22|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.07|1.22|0.0004
91787935|NCT01733212|183455882|EQUIVALENCE|Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.||||||0.07|||||||Chi-squared|||Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.||||0.07
91605646|NCT00775021|183104288|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2489|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|98.7|-0.1301|0.2489|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.||0.2489|-0.1301|
91605647|NCT05817045|183104322|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.01||||0.948|TWO_SIDED|95.0|0.777|1.31|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent recurrence or disease progression (until the end of the study) Full Analysis Set (FAS)||1.310|0.777|0.948
91605648|NCT05817045|183104322|SUPERIORITY|Per-Protocol Population|Hazard Ratio (HR)|1.02||||0.902|TWO_SIDED|95.0|0.774|1.337||adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score.|NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) Per-Protocol Population||1.337|0.774|0.902
91651549|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.1396|TWO_SIDED|95.0|0.94|1.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.55|0.94|0.1396
91651550|NCT01360632|183194683|SUPERIORITY_OR_OTHER||Ratio of response rate|1.46||||0.0016|TWO_SIDED|95.0|1.15|1.86|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.86|1.15|0.0016
91787936|NCT00864916|183455969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.52|||||||Regression, Linear|||||||0.52
91787937|NCT00470834|183455986|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Log Rank|||||||0.79
91605649|NCT05817045|183104322|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.02||||0.859|TWO_SIDED|95.0|0.782|1.342|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) - Secondary Analysis (FAS excluding subjects that were qPCR negative at baseline)||1.342|0.782|0.859
91605650|NCT05817045|183104324|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.29||||0.017|TWO_SIDED|95.0|1.047|1.596|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)||1.596|1.047|0.017
91605651|NCT05817045|183104324|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.33||||0.014|TWO_SIDED|95.0|1.059|1.665|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (Per-Protocol population)||1.665|1.059|0.014
91605652|NCT05817045|183104324|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.35||||0.007|TWO_SIDED|95.0|1.086|1.69|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) - Secondary analysis - (FAS excluding subjects that were qPCR negative at baseline)||1.690|1.086|0.007
91605653|NCT05817045|183104324|SUPERIORITY|SARS-CoV-2 rapid antigen test type: Flowflex|Cox Proportional Hazard|1.46|||||TWO_SIDED|95.0|1.064|1.997|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.997|1.064|
91605654|NCT05817045|183104324|SUPERIORITY|SARS-CoV-2 rapid antigen test type: BinaxNOW|Cox Proportional Hazard|1.12|||||TWO_SIDED|95.0|0.801|1.561|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Subgroup Analysis - Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.561|0.801|
91651551|NCT02046369|183194743|SUPERIORITY|The primary efficacy endpoint (the change from baseline in CDRS-R total score at Week 6)will be analyzed using a likelihood-based mixed model for repeated measures (MMRM).The response (dependent) variable is the change from baseline in CDRS-R total score assessed weekly (Weeks 1 to 6).The MMRM model includes fixed effects terms for treatment, visit (as a categorical variable), pooled country, age stratum (stratification factor, CDRS-R total score at baseline, and treatment-by-visit interaction.|LS mean differnce (SE)|-5.7|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.4|-3.0|||LS mean differnece (SE)|||A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .||-3.0|-8.4|<0.0001
91651552|NCT02046369|183194744|SUPERIORITY||LS mean differnce (SE)|-1.1|STANDARD_ERROR_OF_MEAN|0.54||0.0385|TWO_SIDED|95.0|-2.2|-0.1|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.1|-2.2|0.0385
91605655|NCT02148029|183104360|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.34|TWO_SIDED|95.0|-1.1|3.1|||t-test, 2 sided||Mean difference = Exercise - Control|||3.1|-1.1|0.34
91605656|NCT02148029|183104361|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.89|TWO_SIDED|95.0|-7.1|8.0|||t-test, 2 sided||Mean difference = Exercise - Control|||8.0|-7.1|0.89
91605657|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|7.2||0.43|TWO_SIDED|95.0|-20.3|8.4|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Physical Functioning (PF) domain score.||8.4|-20.3|0.43
91605658|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.13|TWO_SIDED|95.0|-1.6|11.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to Physical health problems (RP) domain score.||11.6|-1.6|0.13
91605659|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.8||0.33|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to mental health or Emotional problems (RE) domain score.||8.2|-2.8|0.33
91605660|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|7.1||0.43|TWO_SIDED|95.0|-8.7|20.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the energy/fatigue/Vitality (VT) domain score.||20.0|-8.7|0.43
91605661|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|5.6||0.64|TWO_SIDED|95.0|-13.8|8.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Mental Health/emotional well-being (MH) domain score.||8.6|-13.8|0.64
91605662|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|8.3||0.64|TWO_SIDED|95.0|-20.5|12.8|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Social Functioning (SF) domain score.||12.8|-20.5|0.64
91651553|NCT02046369|183194745|SUPERIORITY||LS mean differnce (SE)|3.9|STANDARD_ERROR_OF_MEAN|1.35||0.0044|TWO_SIDED|95.0|1.2|6.5|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||6.5|1.2|0.0044
91651554|NCT02046369|183194746|SUPERIORITY||LS mean differnce (SE)|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.0001|TWO_SIDED|95.0|2.4|7.0|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||7.0|2.4|<0.0001
91651555|NCT02046369|183194747|SUPERIORITY||LS mean differnce (SE)|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.3715|TWO_SIDED|95.0|-2.2|0.8|||ANCOVA|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||0.8|-2.2|0.3715
91651556|NCT02046369|183194748|SUPERIORITY||LS mean differnce (SE)|-0.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-0.66|-0.22||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|LS mean differnece (SE)|||||-0.22|-0.66|<0.0001
91651557|NCT04345471|183194769|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-0.6||||0.509|TWO_SIDED|95.0|-2.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-2.5|0.509
91651558|NCT04345471|183194769|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-1.4||||0.131|TWO_SIDED|95.0|-3.3|0.4||A priori threshold for statistical significance is p\<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.|MMRM|||||0.4|-3.3|0.131
91787938|NCT00470834|183455986|SUPERIORITY_OR_OTHER||Relative Risk|0.94|||||TWO_SIDED|95.0|0.61|1.46|||||The hazard ratio is based on the Cox proportional hazards model.|||1.46|0.61|
91605663|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|10.1||0.35|TWO_SIDED|95.0|-10.7|29.7|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Bodily Pain (BP) domain score.||29.7|-10.7|0.35
91605664|NCT02148029|183104362|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5|TWO_SIDED|95.0|-14.1|7.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the General Health (GH) domain score.||7.0|-14.1|0.50
91605665|NCT02148029|183104363|SUPERIORITY||Mean Difference (Net)|-33.9|STANDARD_ERROR_OF_MEAN|30.1||0.27|TWO_SIDED|95.0|-95.5|27.7|||t-test, 2 sided||Mean difference = Exercise - Control|||27.7|-95.5|0.27
91605666|NCT02148029|183104364|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.07|TWO_SIDED|95.0|-3.4|0.1|||t-test, 2 sided||Mean difference = Reflux - No reflux|||0.1|-3.4|0.07
91605667|NCT02148029|183104365|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.4||0.91|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided||Mean difference = PTS - No PTS|||0.9|-0.8|0.91
91605668|NCT03905928|183104366|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise general linear model conducted in FSL software using a one-sample t-test on the tobacco\>strawberry condition contrasts conducted at the subject-level.|A whole-brain, one-sample t-test was used with a voxel threshold p \<.001 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
91605669|NCT03905928|183104367|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention that differ by the nicotine groups (18 mg/ml vs. 0 mg/ml) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
91605670|NCT03905928|183104368|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention between the flavor groups (tobacco vs. strawberry) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
91651559|NCT04345471|183194771|SUPERIORITY||LS mean difference|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-1.5|0.811
91605671|NCT03905928|183104369|SUPERIORITY|||||||0.573|||||||ANOVA|||We conducted a one-way ANOVA to compare the change in e-cigarette dependence (week 4 - week 2 PSECDI difference score) between the four e-cigarette groups.||||0.573
91651560|NCT04345471|183194771|SUPERIORITY||LS mean difference|-0.5||||0.424|TWO_SIDED|95.0|-1.9|0.8||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||0.8|-1.9|0.424
91651561|NCT01710306|183194784|SUPERIORITY|||||||0.1996|||||||Chi-squared|||||||0.1996
91651562|NCT00185211|183194800|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to CDMS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to CDMS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.0027
91787939|NCT00470834|183455986|SUPERIORITY_OR_OTHER||Relative Risk Reduction|5.62|||||TWO_SIDED|95.0|-46.14|39.05|||||Relative Risk Reduction = 100 \* (1 - Relative Risk).|||39.05|-46.14|
91790952|NCT02880956|183460088|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523424|NCT05559866|182922609|OTHER|Variance||||||0.53||||||alpha = 0.05|ANCOVA|1 degree of freedom||||||0.53
91605672|NCT03905928|183104371|SUPERIORITY|||||||0.022|||||||ANOVA|||We conducted a one-way ANOVA to compare changes in self-reported craving across all groups.||||.022
91605673|NCT03619213|183104372|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0008|TWO_SIDED|95.0|0.73|0.92|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.92|0.73|0.0008
91605674|NCT03619213|183104373|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0085|TWO_SIDED|95.0|0.73|0.95|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.95|0.73|0.0085
91605675|NCT03619213|183104374|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0003|TWO_SIDED|95.0|0.67|0.89|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.89|0.67|0.0003
91605676|NCT03619213|183104375|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0017|TWO_SIDED|95.0|0.65|0.9|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.90|0.65|0.0017
91605677|NCT03619213|183104376|SUPERIORITY||Rate Ratio (RR)|1.11||||0.0086|TWO_SIDED|95.0|1.03|1.21||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score, stratified by T2DM status at randomisation.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in KCCQ Total Symptom Score at 8 months, or death before 8 months.|Comparison Group: Placebo||1.21|1.03|0.0086
91605678|NCT03619213|183104377|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1678|TWO_SIDED|95.0|0.74|1.05|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.05|0.74|0.1678
91605679|NCT03619213|183104378|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3425|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.07|0.83|0.3425
91605680|NCT00461175|183104384|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.96|2.7|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, breastfeeding at time of insertion and parity status.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.70|0.96|
91605681|NCT00461175|183104384|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.99|2.78|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, time since last delivery, experience of the inserting health care provider.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.78|0.99|
91605682|NCT00461175|183104385|SUPERIORITY_OR_OTHER||Pearl Index|0.06|||||TWO_SIDED|95.0|0.04|0.09||||||||0.09|0.04|
91605683|NCT00461175|183104385|SUPERIORITY_OR_OTHER||Pearl Index|0.52|||||TWO_SIDED|95.0|0.42|0.64||||||||0.64|0.42|
91605684|NCT00461175|183104385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||||TWO_SIDED|95.0|0.1|0.25|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, and parity.|||0.25|0.10|
91605685|NCT02514044|183104386|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.008|||||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.008
91605686|NCT02514044|183104387|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.02
91605687|NCT01053312|183104417|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.688||||0.098|TWO_SIDED||||||Regression, Linear|||Contralateral to the biopsy Site||||0.098
91605688|NCT01053312|183104417|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.482||||0.268|||||||Regression, Linear|||Ipsilateral to the biopsy Site||||0.268
91605689|NCT01053312|183104417|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.685||||0.099|||||||Regression, Linear|||Composite Region||||0.099
91605690|NCT02203149|183104443|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-14.5|10.0|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-14.5|
91790953|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.146||0.202|TWO_SIDED|95.0|-0.473|0.1||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.100|-0.473|0.202
91523425|NCT05559866|182922610|OTHER|Variance||||||0.91||||||alpha = 0.05|ANCOVA|1 degree of freedom||||||0.91
91605691|NCT02203149|183104444|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-6.0|2.8|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||2.8|-6.0|
91605692|NCT02537678|183104447|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.43||0.006|ONE_SIDED|97.5|-3.26||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.26|.006
91605693|NCT02537678|183104448|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|1.49||0.004|ONE_SIDED|97.5|-3.47||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.47|.004
91605694|NCT02537678|183104449|NON_INFERIORITY|We planned 0.41standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied 12-month assessment.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.2||0.001|ONE_SIDED|97.5|-2.5||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.50|.001
91605695|NCT02537678|183104450|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|ONE_SIDED|97.5|-2.94||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.94|<0.001
91605696|NCT02537678|183104451|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|2.25||0.044|ONE_SIDED|97.5|-6.33||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.33|.044
91605697|NCT02537678|183104452|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.75||0.002|ONE_SIDED|97.5|-3.07||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.07|0.002
91790954|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91605698|NCT02537678|183104453|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.52||0.016|ONE_SIDED|97.5|-4.06||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.06|0.016
91605699|NCT02537678|183104454|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.77||0.003|ONE_SIDED|97.5|-3.72||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.72|0.003
91605700|NCT02537678|183104455|NON_INFERIORITY|We planned 0.41 standard deviation the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.89||0.007|ONE_SIDED|97.5|-3.89||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.89|0.007
91605701|NCT02537678|183104456|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.64||0.008|ONE_SIDED|97.5|-4.24||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.24|0.008
91523426|NCT05559866|182922611|OTHER|||||||0.307|||||||Chi-squared|Chi-Square: 1.043478||||||0.307
91605702|NCT02537678|183104457|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.78||0.015|ONE_SIDED|97.5|-4.88||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.88|0.015
91605703|NCT02537678|183104458|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|1.99||0.024|ONE_SIDED|97.5|-5.68||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.68|0.024
91605704|NCT02537678|183104459|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.001|ONE_SIDED|97.5|-0.39||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.39|0.001
91605705|NCT02537678|183104460|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.003|ONE_SIDED|97.5|-0.47||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.47|0.003
91651563|NCT00185211|183194800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.663||||0.0028||97.47|0.488|0.902|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to CDMS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for CDMS, i.e. hazard ratio = 1.||0.902|0.488|0.0028
91651564|NCT00185211|183194801|SUPERIORITY_OR_OTHER|||||||0.1768||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was: H0: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are not identical for both treatment arms for some points in time t\>0. The two-sided alternative hypothesis was: H1: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are identical for both treatment arms for some points in time t\>0.||||0.1768
91651565|NCT00185211|183194801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.1604||97.47|0.497|1.174|||Regression, Cox|The variable used as additional covariate adjustment was volume of T2 lesions on screening MRI.|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to confirmed EDSS progression was modelled by a Cox proportional hazards regression model with the following covariates: treatment group and volume of T2 lesions on screening MRI. The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for confirmed EDSS progression, i.e. hazard ratio = 1.||1.174|0.497|0.1604
91651566|NCT00185211|183194802|SUPERIORITY_OR_OTHER|||||||0.888||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|non-parametric ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a non-parametric analysis of covariance (ANCOVA)."||||0.8880
91790955|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.144||0.76|TWO_SIDED|95.0|-0.327|0.239||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.239|-0.327|0.760
91605706|NCT02537678|183104461|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|ONE_SIDED|97.5|-0.3||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.30|<0.001
91605707|NCT02537678|183104462|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.001|ONE_SIDED|97.5|-0.29||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.29|0.001
91605708|NCT02537678|183104463|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.004|ONE_SIDED|97.5|-0.38||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.38|0.004
91605709|NCT02537678|183104464|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|ONE_SIDED|97.5|-0.19||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.19|<0.001
91605710|NCT02537678|183104465|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.47||0.005|ONE_SIDED|97.5|-3.33||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.33|0.005
91787940|NCT00977080|183456001|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the IV stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.016
91605711|NCT02537678|183104466|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.78||0.028|ONE_SIDED|97.5|-4.99||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.99|0.028
91605712|NCT02537678|183104467|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.62||0.009|ONE_SIDED|97.5|-3.64||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.64|0.009
91605713|NCT02537678|183104468|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.9||0.006|ONE_SIDED|97.5|-2.82||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.82|0.006
91605714|NCT02537678|183104469|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.88||0.001|ONE_SIDED|97.5|-2.31||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.31|0.001
91605715|NCT02537678|183104470|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Median Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|ONE_SIDED|97.5|-1.43||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-1.43|<0.001
91605716|NCT02537678|183104471|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|ONE_SIDED|97.5|-5.04||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.04|<0.001
91605717|NCT02537678|183104472|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.27||0.003|ONE_SIDED|97.5|-6.87||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.87|0.003
91605718|NCT02537678|183104473|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults.Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|ONE_SIDED|97.5|-5.8||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.80|<0.001
91605719|NCT00432809|183104503|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
91605720|NCT00432809|183104503|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
91605721|NCT00432809|183104503|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Not adjusted for multiple comparisons|Chi-squared|||||||0.59
91605722|NCT00432809|183104507|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605723|NCT00432809|183104507|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605724|NCT00432809|183104507|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
91605725|NCT00432809|183104508|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
91605726|NCT00432809|183104508|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
91605727|NCT00432809|183104508|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
91605728|NCT00432809|183104509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605729|NCT00432809|183104509|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
91605730|NCT00432809|183104509|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||||||0.23
91605731|NCT00432809|183104510|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Medical Therapy vs. Gastric Bypass||||<0.001
91605732|NCT00432809|183104510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605733|NCT00432809|183104510|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||||||0.10
91605734|NCT00432809|183104511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91787941|NCT00977080|183456001|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.260
91605735|NCT00432809|183104511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91709609|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|6.8|||||TWO_SIDED|95.0|5.69|8.13||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||8.13|5.69|
91605736|NCT00432809|183104511|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
91605737|NCT00432809|183104512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605738|NCT00432809|183104512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605739|NCT00432809|183104512|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
91605740|NCT00432809|183104513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605741|NCT00432809|183104513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605742|NCT00432809|183104513|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
91605743|NCT00432809|183104514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605744|NCT00432809|183104514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91605745|NCT00432809|183104514|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
91605746|NCT00432809|183104515|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
91605747|NCT00432809|183104515|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
91605748|NCT00432809|183104515|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
91605749|NCT00432809|183104516|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
91605750|NCT00432809|183104516|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
91605751|NCT00432809|183104516|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||||||0.98
91605752|NCT00432809|183104517|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91605753|NCT00432809|183104517|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
91605754|NCT00432809|183104517|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.17
91787942|NCT00977080|183456002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91787943|NCT00977080|183456002|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Fisher Exact|||||||0.239
91605755|NCT00432809|183104518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91605756|NCT00432809|183104518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91605757|NCT00432809|183104518|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.59
91605758|NCT00432809|183104519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605759|NCT00432809|183104519|SUPERIORITY_OR_OTHER|||||||1.001||95.0|||||Chi-squared|||||||1.001
91605760|NCT00432809|183104519|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Chi-squared|||||||0.68
91605761|NCT00432809|183104520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605762|NCT00432809|183104520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605763|NCT00432809|183104520|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
91605764|NCT00432809|183104521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605765|NCT00432809|183104521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605766|NCT00432809|183104521|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91605767|NCT00432809|183104522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605768|NCT00432809|183104522|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
91605769|NCT00432809|183104522|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
91605770|NCT00432809|183104523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605771|NCT00432809|183104523|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91605772|NCT00432809|183104523|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
91605773|NCT00432809|183104524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605774|NCT00432809|183104524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605775|NCT00432809|183104524|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
91605776|NCT00432809|183104525|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Chi-squared|||||||0.48
91787944|NCT00977080|183456003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91605777|NCT00432809|183104525|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Chi-squared|||||||0.46
91605778|NCT00432809|183104525|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91605779|NCT00432809|183104526|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91651567|NCT00185211|183194802|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a parametric analysis of covariance (ANCOVA)."||||0.3832
91605780|NCT00432809|183104526|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605781|NCT00432809|183104526|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
91605782|NCT00432809|183104527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605783|NCT00432809|183104527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91605784|NCT00432809|183104527|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||||||0.03
91651568|NCT00185211|183194803|SUPERIORITY_OR_OTHER|||||||6e-06||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.000006
91651569|NCT00185211|183194803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.583|||<|1e-06||95.0|0.474|0.718|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b versus initial placebo, i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to McDonald MS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for McDonald MS, i.e. hazard ratio = 1.||0.718|0.474|< 0.000001
91605785|NCT01499290|183104528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-3.5|||||TWO_SIDED|95.0|-8.64|1.58||||||The primary objective of this study (FDA agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the mMITT in adult subjects with cIAI.||1.58|-8.64|
91605786|NCT01499290|183104529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-6.9|2.1||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the MITT in adult subjects with cIAI.||2.10|-6.90|
91787945|NCT00977080|183456003|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||Fisher Exact|||||||0.704
91787946|NCT00977080|183456004|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.010
91787947|NCT00977080|183456005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91787948|NCT00977080|183456005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91605787|NCT01499290|183104530|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.61|2.89||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the CE in adult subjects with cIAI.||2.89|-4.61|
91605788|NCT00552110|183104541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||"Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.~Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points."||||0.002
91605789|NCT00552110|183104541|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.||||<0.001
91605790|NCT00552110|183104541|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.||||<0.001
91605791|NCT00552110|183104542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.||||0.021
91605792|NCT00552110|183104542|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily||||<0.001
91605793|NCT00552110|183104542|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo||||<0.001
91605794|NCT00700804|183104544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_DEVIATION|2.5||0.05|||||||Mixed Models Analysis|Effects of calcium (Ca), protein \& their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)|Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.|||||0.05
91605795|NCT05775289|183104545|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9705|TWO_SIDED|95.0|0.63|1.56|||Log Rank|||||1.56|0.63|0.9705
91605796|NCT05775289|183104546|SUPERIORITY||Odds Ratio (OR)|0.77||||0.4056|TWO_SIDED|95.0|0.42|1.43|||Cochran-Mantel-Haenszel|||||1.43|0.42|0.4056
91605797|NCT04336397|183104571|SUPERIORITY||Odds Ratio (OR)|1.2||||0.04|TWO_SIDED|95.0|1.0|1.5|||Chi-squared|||||1.5|1.0|0.04
91605798|NCT04336397|183104571|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91605799|NCT01587989|183104581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327||||0.188|TWO_SIDED|95.0|-0.165|0.82|||t-test, 2 sided|||||0.820|-0.165|0.188
91605800|NCT01587989|183104581|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANCOVA|||At Week 12.||||0.015
91787949|NCT00977080|183456006|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Fisher Exact|||||||0.118
91605801|NCT01587989|183104581|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANCOVA|||Adjusted change in DAS28 score from Weeks 12-24.||||0.304
91605802|NCT01587989|183104582|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Fisher Exact|||||||0.732
91605803|NCT01587989|183104583|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Fisher Exact|||||||0.207
91605804|NCT01587989|183104584|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Fisher Exact|||||||0.453
91605805|NCT01587989|183104585|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Fisher Exact|||||||0.084
91787950|NCT00977080|183456006|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91787951|NCT00096356|183456025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.03||0.1815|TWO_SIDED|95.0|-3.39|0.64||The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.|Mixed Models Analysis||This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.||0.64|-3.39|0.1815
91790956|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91605806|NCT01587989|183104586|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.842
91605807|NCT01587989|183104587|SUPERIORITY_OR_OTHER|||||||0.417|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Physical standardized value||||0.417
91605808|NCT01587989|183104587|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mental standardized value||||0.112
91605809|NCT01587989|183104588|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.655
91605810|NCT01587989|183104588|SUPERIORITY_OR_OTHER|||||||0.839|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Pain||||0.839
91605811|NCT01587989|183104589|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Effectiveness||||0.580
91605812|NCT01587989|183104589|SUPERIORITY_OR_OTHER|||||||0.975|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Side-effects||||0.975
91605813|NCT01587989|183104589|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Convenience||||0.421
91605814|NCT01587989|183104589|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Global satisfaction||||0.277
91605815|NCT04211337|183104606|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.165|0.475|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.475|0.165|<0.0001
91605816|NCT04211337|183104607|SUPERIORITY||Hazard Ratio (HR)|0.254|||<|0.0001|TWO_SIDED|95.0|0.153|0.423|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.423|0.153|<0.0001
91605817|NCT04211337|183104608|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.2|6.3||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)|Clopper-Pearson method|||||6.3|2.2|<0.0001
91605818|NCT04211337|183104609|SUPERIORITY||Hazard Ratio (HR)|0.275||||0.0004|TWO_SIDED|95.0|0.129|0.587|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).||||0.587|0.129|0.0004
91605819|NCT04211337|183104612|SUPERIORITY||Mean Difference (Final Values)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.23|-0.1||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Wilcoxon (Mann-Whitney)|||||-0.10|-0.23|<0.0001
91605820|NCT05818124|183104643|OTHER||Difference in Least Squares Mean|-0.48||||0.783|TWO_SIDED|95.0|-3.97|3.0|||ANOVA|||||3.00|-3.97|0.783
91605821|NCT05818124|183104644|OTHER||Difference in Least Squares Mean|-2.21||||0.032|TWO_SIDED|95.0|-4.21|-0.21|||ANOVA|||||-0.21|-4.21|0.032
91605822|NCT05818124|183104645|OTHER||Difference in Least Squares Mean|0.2||||0.756|TWO_SIDED|95.0|-1.07|1.47|||ANOVA|||||1.47|-1.07|0.756
91605823|NCT05818124|183104646|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-23.21|23.21||||||||23.21|-23.21|
91605824|NCT05818124|183104647|OTHER|Clopper and Pearson binomial method|Difference in percentage|-2.86|||||TWO_SIDED|95.0|-25.78|20.27||||||||20.27|-25.78|
91605825|NCT05818124|183104648|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|-8.57|||||TWO_SIDED|95.0|-30.26|13.38||||||||13.38|-30.26|
91605826|NCT05818124|183104649|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
91605827|NCT05818124|183104650|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
91605828|NCT05818124|183104651|OTHER|Clopper and Pearson binomial method|Difference in percentage|-8.57|||||TWO_SIDED|95.0|-27.63|10.5||||||||10.50|-27.63|
91787952|NCT00096356|183456026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|2.31||0.3903|TWO_SIDED|95.0|-2.56|6.53||0.05 significance level; no multiple comparison adjustment|Mixed Models Analysis||This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.|Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates||6.53|-2.56|.3903
91651570|NCT00185211|183194804|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.1265||95.0|0.595|1.066||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Andersen-Gill Model|Covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|The time to recurrent relapses was modelled by an extension of Cox's PH regression model (Andersen-Gill Model) for recurrent events with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for recurrent relapses, i.e. hazard ratio = 1.||1.066|0.595|0.1265
91651571|NCT00185211|183194805|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7971||||0.0141||95.0|0.665|0.9554||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear Poisson regression|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Risk Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Relapse rate was analyzed by a generalized linear Poisson regression model with individual relapse counts as dependent variable, covariates: treatment arm, steroid use during first event, onset of disease and categorized number of T2 lesions at screening and offset variable natural log of time (in years) as difference between last clinical visit and baseline visit. The treatment effect on the relapse rate was of primary interest.||0.9554|0.6650|0.0141
91651572|NCT00185211|183194806|SUPERIORITY_OR_OTHER|||||||0.6078||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.6078
91651573|NCT00185211|183194806|SUPERIORITY_OR_OTHER|||||||0.8245||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are identical for both treatment arms was tested against the alternative hypothesis HA: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.8245
91651574|NCT00185211|183194807|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: number of Gd-enhancing lesions on T1 at screening||"The null hypothesis H0: The distribution of the cumulative number of newly active lesions at month 60 adjusted for the number of Gadolinium (Gd)-enhancing lesions on T1 at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.0062
91651575|NCT00185211|183194807|SUPERIORITY_OR_OTHER||Relative effect size|0.7351||||0.0435||95.0|0.5436|0.994||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear model|Distribution: negative binomial distribution; covariate: number of Gd-enhancing lesions on T1 at screening|The direction of comparison is initial IFNB-1b versus initial placebo.|Assuming that the cumulative number of newly active lesions at month 60 follows a negative binomial distribution, a generalized linear model (logarithmic link function, covariate: number of Gd-enhancing lesions on T1 at BENEFIT screening) was set up in order to analyze the treatment effect on that MRI outcome.||0.9940|0.5436|0.0435
91651576|NCT00185211|183194808|SUPERIORITY_OR_OTHER|||||||0.7801||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The distribution of the absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.7801
91651577|NCT00185211|183194808|SUPERIORITY_OR_OTHER|||||||0.9408||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The mean absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.9408
91787953|NCT00096356|183456027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.31||0.6014|TWO_SIDED|95.0|-3.25|1.88||0.05 significance level, unadjusted for multiple comparisons|Mixed Models Analysis||This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates||1.88|-3.25|.6014
91787954|NCT01181986|183456028|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence, group (diabetes duration) and time.||||||<0.0001
91787955|NCT01181986|183456028|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANCOVA|Adjusted for treatment sequence.||||||0.006
91787956|NCT01181986|183456028|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for treatment sequence.||||||0.003
91605829|NCT05818124|183104654|OTHER||Hazard Ratio (HR)|0.82||||0.3102|TWO_SIDED|95.0|0.51|1.33|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.33|0.51|0.3102
91605830|NCT05818124|183104655|OTHER||Hazard Ratio (HR)|0.55||||0.0779|TWO_SIDED|95.0|0.27|1.14|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.14|0.27|0.0779
91605831|NCT05818124|183104658|OTHER||Difference in Least Squares Mean|-3.79||||0.045|TWO_SIDED|95.0|-7.47|-0.1|||ANOVA|||||-0.10|-7.47|0.045
91605832|NCT05818124|183104659|OTHER||Difference in Least Squares Mean|-2.56||||0.226|TWO_SIDED|95.0|-6.81|1.69|||ANOVA|||||1.69|-6.81|0.226
91605833|NCT05818124|183104660|OTHER||Difference in Least Squares Mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
91605834|NCT05818124|183104661|OTHER||Difference in Least Squares Mean|0.74||||0.609|TWO_SIDED|95.0|-2.19|3.66|||ANOVA|||||3.66|-2.19|0.609
91605835|NCT05818124|183104662|OTHER|Difference in Least Squares Mean|Difference in Least Squares Mean|0.34||||0.614|TWO_SIDED|95.0|-1.04|1.72|||ANOVA|||||1.72|-1.04|0.614
91605836|NCT05818124|183104663|OTHER||Difference in Least Squares Mean|0.37||||0.608|TWO_SIDED|95.0|-1.09|1.83|||ANOVA|||||1.83|-1.09|0.608
91605837|NCT05818124|183104664|OTHER||Difference in Least Squares Mean|0.43||||0.288|TWO_SIDED|95.0|-0.39|1.25|||ANOVA|||||1.25|-0.39|0.288
91605838|NCT05818124|183104665|OTHER||Difference in Least Squares Mean|0.09||||0.842|TWO_SIDED|95.0|-0.8|0.97|||ANOVA|||||0.97|-0.80|0.842
91605839|NCT05818124|183104668|OTHER||Hazard Ratio (HR)|0.31||||0.0042|TWO_SIDED|95.0|0.14|0.71|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.71|0.14|0.0042
91605840|NCT05818124|183104669|OTHER||Hazard Ratio (HR)|0.69||||0.329|TWO_SIDED|95.0|0.33|1.46|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.46|0.33|0.3290
91605841|NCT05818124|183104670|OTHER||Hazard Ratio (HR)|0.6||||0.1502|TWO_SIDED|95.0|0.27|1.34|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.34|0.27|0.1502
91605842|NCT05818124|183104671|OTHER||Hazard Ratio (HR)|1.32||||0.4865|TWO_SIDED|95.0|0.59|2.92|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.92|0.59|0.4865
91605843|NCT05818124|183104674|OTHER||Difference in Least Squares Mean|-4.79||||0.313|TWO_SIDED|95.0|-14.36|4.78|||ANOVA|||||4.78|-14.36|0.313
91787957|NCT01181986|183456029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence and diabetes duration group.||||||<0.0001
91787958|NCT01181986|183456030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91605844|NCT05818124|183104675|OTHER||Difference in Least Squares Mean|-6.87||||0.138|TWO_SIDED|95.0|-16.11|2.36|||ANOVA|||||2.36|-16.11|0.138
91605845|NCT05818124|183104676|OTHER||Difference in LS mean|0.74||||0.706|TWO_SIDED|95.0|-3.26|4.74|||ANOVA|||||4.74|-3.26|0.706
91605846|NCT05818124|183104677|OTHER||Difference in LS mean|-1.58||||0.367|TWO_SIDED|95.0|-5.1|1.95|||ANOVA|||||1.95|-5.10|0.367
91605847|NCT05818124|183104683|OTHER||Difference in LS Mean|-4.14||||0.177|TWO_SIDED|95.0|-10.2|1.92|||ANOVA|||||1.92|-10.20|0.177
91605848|NCT05818124|183104684|OTHER||Difference in LS mean|-0.97||||0.395|TWO_SIDED|95.0|-3.24|1.29|||ANOVA|||||1.29|-3.24|0.395
91605849|NCT05818124|183104696|OTHER|Difference in least squares mean|Difference in least squares means|-0.94||||0.11|TWO_SIDED|95.0|-2.1|0.22|||ANOVA|||||0.22|-2.10|0.110
91605850|NCT05818124|183104697|OTHER||Difference in least squares mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
91605851|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.108|0.157||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.157|0.108|<0.0001
91605852|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.078|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.078|<0.0001
91605853|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.096|0.145||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.145|0.096|< 0.0001
91605854|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.106|0.155||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.155|0.106|<0.0001
91605855|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.066|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.115|0.066|<0.0001
91605856|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3394|TWO_SIDED|95.0|-0.013|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.036|-0.013|0.3394
91787959|NCT01675167|183456039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98|||<|1e-05|TWO_SIDED|95.0|-1.32|-0.64||P value was adjusted using weighted z-test (CHW).|ANCOVA|||||-0.64|-1.32|<.00001
91651578|NCT00185211|183194809|SUPERIORITY_OR_OTHER|||||||0.6619||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The distribution of the absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.6619
91651579|NCT00185211|183194809|SUPERIORITY_OR_OTHER|||||||0.8558||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The mean absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.8558
91651580|NCT00185211|183194810|SUPERIORITY_OR_OTHER|||||||0.1208||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The distribution of the percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.1208
91651581|NCT00185211|183194810|SUPERIORITY_OR_OTHER|||||||0.0719||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The mean percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.0719
91651582|NCT00420290|183194822|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||0.031 is the upper level of significance|ANCOVA|||Using data from 128 CHD patients, CRP data were highly skewed, and data were log transformed to achieve normality. With 14 pts in each group (total of 28), it was predicted the minimum detectable difference between control and intervention would be 15% (1.22 for control group and 1.00 for the intervention group), with an 80% power and an alpha of 0.05 using t test approach. Thus, planned sample size was 30 to complete the study.||||0.008
91651583|NCT00420290|183194823|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.03
91651584|NCT00420290|183194824|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91651585|NCT00420290|183194825|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91651586|NCT00420290|183194826|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91651587|NCT00972153|183194828|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
91651588|NCT00972153|183194829|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
91709610|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.76|1.2||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.76|
91787960|NCT01675167|183456040|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||<.0001
91651589|NCT04136626|183194840|SUPERIORITY||Mean Difference (Final Values)|-2.0475||||0.0871|TWO_SIDED|95.0|-4.3977|0.3027||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Y-BOCS total scores between the treatment groups at endpoint (week 12).||0.3027|-4.3977|0.0871
91787961|NCT01675167|183456040|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by Stratum (Dose Level)||Responders with ≥50% pain reduction||||<.0001
91787962|NCT04531462|183456054|SUPERIORITY|Null hypothesis: Mean change from baseline in HbA1c after 52 weeks of treatment with empagliflozin 10 mg = mean change from baseline in HbA1c after 52 weeks of treatment with placebo.|Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||Threshold level for statistical significance: α = 0.05 .|Mixed Model Repeated Measures (MMRM)||Empagliflozin 10 mg- Placebo|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) which included fixed classification effects for treatment, gender, baseline renal function, visit and visit-by-treatment interaction, and a linear covariate for baseline HbA1c and age. An unstructured covariance structure was used to model the within patient errors. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||-0.36|-0.78|<0.0001
91787963|NCT04531462|183456055|OTHER||Mean Difference (Net)|-0.61||||0.231|TWO_SIDED|95.0|-1.61|0.39|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.39|-1.61|0.2310
91787964|NCT04531462|183456056|OTHER||Mean Difference (Net)|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.65|-1.04|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-1.04|-2.65|<0.0001
91787965|NCT04531462|183456057|OTHER||Mean Difference (Net)|-0.53||||0.1632|TWO_SIDED|95.0|-1.28|0.22|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.22|-1.28|0.1632
91787966|NCT04531462|183456058|OTHER||Mean Difference (Net)|-0.63||||0.0384|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-0.03|-1.23|0.0384
91787967|NCT04531462|183456059|OTHER||Mean Difference (Net)|-0.03||||0.1975|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.01|-0.07|0.1975
91605857|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.118|0.167||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.167|0.118|<0.0001
91605858|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0173|TWO_SIDED|95.0|0.005|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.005|0.0173
91605859|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.035|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.014|-0.035|0.4210
91605860|NCT01431287|183104716|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|0.015|0.0014
91605861|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.063|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.063|<0.0001
91605862|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.024|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.075|0.024|0.0001
91605863|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.042|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.092|0.042|<0.0001
91605864|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.087|0.037|<0.0001
91605865|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0231|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.004|0.0231
91787968|NCT04531462|183456060|OTHER||Mean Difference (Net)|-0.081||||0.3725|TWO_SIDED|95.0|-0.259|0.098|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.098|-0.259|0.3725
91787969|NCT04531462|183456061|OTHER||Mean Difference (Net)|-0.3||||0.4208|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.5|-1.1|0.4208
91605866|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.1073|TWO_SIDED|95.0|-0.004|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.046|-0.004|0.1073
91787970|NCT04531462|183456062|OTHER||Mean Difference (Net)|0.0||||0.9267|TWO_SIDED|95.0|-1.0|0.9|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.9|-1.0|0.9267
91605867|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.083|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.058|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.058|<0.0001
91605868|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.013|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.013|0.0029
91605869|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6939|TWO_SIDED|95.0|-0.02|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.030|-0.020|0.6939
91605870|NCT01431287|183104717|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0097|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.058|0.008|0.0097
91605871|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.608|-2.778|0.0022
91651590|NCT04136626|183194840|SUPERIORITY||Difference in the amount of change|-3.4385||||0.0036|TWO_SIDED|95.0|-5.7394|-1.1376||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment Y-BOCS total scores between the treatment groups.||-1.1376|-5.7394|0.0036
91787971|NCT03859973|183456068|OTHER||Mean Difference (Net)|-0.866||||0.3101|TWO_SIDED|95.0|-2.605|0.833|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.833|-2.605|0.3101
91787972|NCT03859973|183456069|OTHER||Mean Difference (Net)|-1.051||||0.2309|TWO_SIDED|95.0|-2.778|0.676|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.676|-2.778|0.2309
91787973|NCT03859973|183456070|OTHER||Mean Difference (Net)|0.577||||0.5237|TWO_SIDED|95.0|-1.207|2.362|||ANCOVA||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.||2.362|-1.207|0.5237
91605872|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.153|-2.313|0.0252
91605873|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.052|-2.113|0.0620
91605874|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.618|-1.531|0.4051
91787974|NCT03859973|183456071|OTHER||Mean Difference (Net)|-0.669||||0.642|TWO_SIDED|95.0|-3.51|2.172|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group.||2.172|-3.510|0.6420
91605875|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.507|-1.649|0.2988
91605876|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.407|-1.731|0.2249
91605877|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.042|-2.195|0.0418
91605878|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.633|-1.552|0.4097
91605879|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.515|-1.664|0.3013
91605880|NCT01431287|183104718|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||1.200|-0.970|0.8355
91605881|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.684|0.155|0.0019
91605882|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.619|0.092|0.0082
91787975|NCT03874429|183456081|NON_INFERIORITY|Non- inferiority was demonstrated if the upper bound of the 95% CI was no higher than 2 points for the the difference of T2259 minus Vismed Multi.|Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.42|1.05|||ANCOVA|||To assess the non inferiority of T2259 compared to Vismed Multi, two-sided 95% confidence interval from ANCOVA model was computed of the difference of T2259 minus Vismed Multi. The model was adjusted for the main effects of investigation product and baseline score.||1.05|-0.42|
91605883|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.681|0.152|0.0020
91605884|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.554|0.027|0.0307
91605885|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.616|0.089|0.0088
91605886|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.266|-0.259|0.9801
91605887|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.557|0.030|0.0289
91605888|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.330|-0.202|0.6382
91605889|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.391|-0.140|0.3525
91605890|NCT01431287|183104719|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.203|-0.327|0.6457
91605891|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0095|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.008|0.0095
91605892|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
91605893|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0112|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0112
91605894|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.068|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.068|<0.0001
91790957|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.147||0.419|TWO_SIDED|95.0|-0.409|0.17||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.170|-0.409|0.419
91790958|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|1.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790959|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.173||0.893|TWO_SIDED|95.0|-0.363|0.317||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.317|-0.363|0.893
91790960|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
91790961|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.886|TWO_SIDED|95.0|-0.306|0.354||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.354|-0.306|0.886
91790962|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91651591|NCT04136626|183194841|SUPERIORITY||Mean Difference (Final Values)|-0.8743||||0.3616|TWO_SIDED|95.0|-2.7666|1.0181||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in depression severity (QIDS-SR total scores) between the treatment groups at endpoint (week 12).||1.0181|-2.7666|0.3616
91605895|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
91605896|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9514|TWO_SIDED|95.0|-0.024|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.024|0.9514
91605897|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.069|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.069|<0.0001
91605898|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0131|TWO_SIDED|95.0|-0.057|-0.007||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.007|-0.057|0.0131
91605899|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.086|-0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.036|-0.086|<0.0001
91605900|NCT01431287|183104720|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0243|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0243
91605901|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.145|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.119|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.170|0.119|<0.0001
91605902|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.085|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.136|0.085|<0.0001
91605903|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.094|<0.0001
91709611|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|8.18|||||TWO_SIDED|95.0|6.75|9.92||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||9.92|6.75|
91605904|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.081|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.132|0.081|<0.0001
91651592|NCT04136626|183194841|SUPERIORITY||Difference in the amount of change|-1.3076||||0.1973|TWO_SIDED|95.0|-3.3014|0.6862||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment depression severity (QIDS-SR total scores) between the treatment groups.||0.6862|-3.3014|0.1973
91523427|NCT05559866|182922612|OTHER|Association|||||||||||||||||Unable to perform Chi-Square test as data in both categorical sets was identical - there is no variation to test.|||
91605905|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.110|0.059|<0.0001
91605906|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.013||0.047|TWO_SIDED|95.0|0.0|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.051|0.000|0.0470
91605907|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.107|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.107|<0.0001
91605908|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.060|0.009|0.0083
91605909|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.3329|TWO_SIDED|95.0|-0.013|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.038|-0.013|0.3329
91605910|NCT01431287|183104721|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.013||0.0958|TWO_SIDED|95.0|-0.004|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.047|-0.004|0.0958
91605911|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
91605912|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.086|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.139|0.086|<0.0001
91605913|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
91605914|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
91790963|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.172||0.306|TWO_SIDED|95.0|-0.515|0.162||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.162|-0.515|0.306
91790964|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|1.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790965|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.116||0.008|TWO_SIDED|95.0|-0.535|-0.079||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.079|-0.535|0.008
91790966|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91605915|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.072|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.125|0.072|<0.0001
91605916|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.3008|TWO_SIDED|95.0|-0.012|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.012|0.3008
91605917|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
91605918|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.014||0.1484|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1484
91605919|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9981|TWO_SIDED|95.0|-0.026|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.026|0.9981
91605920|NCT01431287|183104722|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.148|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1480
91605921|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
91605922|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.005|TWO_SIDED|95.0|0.011|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.011|0.0050
91605923|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.089|0.039|<0.0001
91605924|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.037|<0.0001
91651593|NCT04136626|183194842|SUPERIORITY||Mean Difference (Final Values)|-2.7992||||0.1289|TWO_SIDED|95.0|-6.4246|0.8262||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in functional impairment (WSAS total scores) between the treatment groups at endpoint (week 12).||0.8262|-6.4246|0.1289
91605925|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0057|TWO_SIDED|95.0|0.01|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.010|0.0057
91605926|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9633|TWO_SIDED|95.0|-0.025|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.025|0.9633
91605927|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.038|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.038|<0.0001
91605928|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.025|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0250
91605929|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.013||0.8949|TWO_SIDED|95.0|-0.023|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.023|0.8949
91605930|NCT01431287|183104723|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0351|TWO_SIDED|95.0|0.002|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.052|0.002|0.0351
91605931|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.105|0.055|<0.0001
91605932|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.022|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.073|0.022|0.0002
91605933|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.101|0.051|<0.0001
91651594|NCT04136626|183194842|SUPERIORITY||Difference in the amount of change|-4.5704||||0.0137|TWO_SIDED|95.0|-8.1939|-0.9468||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment functional impairment (WSAS total scores) between the treatment groups.||-0.9468|-8.1939|0.0137
91651595|NCT04136626|183194843|SUPERIORITY||Mean Difference (Final Values)|4.3953||||0.1796|TWO_SIDED|95.0|-2.0543|10.8448||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in quality of life (Q-LES-Q-SF percentage scores) between the treatment groups at endpoint (week 12).||10.8448|-2.0543|0.1796
91790967|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.115||0.031|TWO_SIDED|95.0|-0.474|-0.023||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.023|-0.474|0.031
91790968|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790969|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.116||0.014|TWO_SIDED|95.0|-0.514|-0.059||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.059|-0.514|0.014
91790970|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
91605934|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.036|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.086|0.036|<0.0001
91605935|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.013||0.0007|TWO_SIDED|95.0|0.018|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.069|0.018|0.0007
91605936|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.013||0.7755|TWO_SIDED|95.0|-0.022|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.029|-0.022|0.7755
91605937|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
91605938|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0118|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0118
91605939|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.013||0.2416|TWO_SIDED|95.0|-0.01|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.010|0.2416
91605940|NCT01431287|183104724|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.013||0.1792|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.043|-0.008|0.1792
91605941|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.074|<0.0001
91605942|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.033|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.084|0.033|<0.0001
91605943|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.057|0.107||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.107|0.057|<0.0001
91605944|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.023|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.073|0.023|0.0002
91605945|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0014|TWO_SIDED|95.0|0.016|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.067|0.016|0.0014
91709612|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|5.97|||||TWO_SIDED|95.0|5.0|7.12||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||7.12|5.00|
91605946|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1747|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.043|-0.008|0.1747
91605947|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.040|<0.0001
91605948|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0016|TWO_SIDED|95.0|0.016|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.066|0.016|0.0016
91605949|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0081|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0081
91605950|NCT01431287|183104725|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.611|TWO_SIDED|95.0|-0.019|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.032|-0.019|0.6110
91605951|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.111|0.059|<0.0001
91605952|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.025|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.076|0.025|0.0001
91605953|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.051|<0.0001
91605954|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.044|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.095|0.044|<0.0001
91605955|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.013||0.0013|TWO_SIDED|95.0|0.016|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|0.016|0.0013
91605956|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5274|TWO_SIDED|95.0|-0.017|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.034|-0.017|0.5274
91605957|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.052|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.103|0.052|<0.0001
91605958|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0083
91605959|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.5744|TWO_SIDED|95.0|-0.018|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.018|0.5744
91605960|NCT01431287|183104726|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0381|TWO_SIDED|95.0|0.001|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.053|0.001|0.0381
91605961|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.055|<0.0001
91605962|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.053|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.027|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|0.027|<0.0001
91605963|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.039|<0.0001
91605964|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.029|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.081|0.029|<0.0001
91605965|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.013||0.0052|TWO_SIDED|95.0|0.011|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.011|0.0052
91605966|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.013||0.2273|TWO_SIDED|95.0|-0.01|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.010|0.2273
91605967|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.045|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|0.045|<0.0001
91605968|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.033|TWO_SIDED|95.0|0.002|0.055||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.055|0.002|0.0330
91605969|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.4327|TWO_SIDED|95.0|-0.016|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.037|-0.016|0.4327
91605970|NCT01431287|183104727|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1764|TWO_SIDED|95.0|-0.008|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.044|-0.008|0.1764
91790971|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.135||0.065|TWO_SIDED|95.0|-0.514|0.016||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.016|-0.514|0.065
91790972|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91605971|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0241|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.007|0.0241
91605972|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.051|0.148||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.148|0.051|<0.0001
91605973|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.025||0.0049|TWO_SIDED|95.0|0.021|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.021|0.0049
91605974|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.196|0.098|<0.0001
91605975|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.064|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.162|0.064|<0.0001
91605976|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.025||0.5831|TWO_SIDED|95.0|-0.063|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.063|0.5831
91605977|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.133|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.182||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.182|0.084|<0.0001
91605978|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0822|TWO_SIDED|95.0|-0.092|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.006|-0.092|0.0822
91605979|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.025||0.002|TWO_SIDED|95.0|-0.126|-0.028||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.028|-0.126|0.0020
91605980|NCT01431287|183104728|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.025||0.1774|TWO_SIDED|95.0|-0.015|0.083||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.083|-0.015|0.1774
91605981|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.169|0.268||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.268|0.169|<0.0001
91651596|NCT04136626|183194843|SUPERIORITY||Difference in the amount of change|6.7962||||0.04|TWO_SIDED|95.0|0.314|13.2785||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment quality of life (Q-LES-Q-SF percentage scores) between the treatment groups.||13.2785|0.3140|0.0400
91605982|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.193|0.094|<0.0001
91787976|NCT00159822|183456109|SUPERIORITY_OR_OTHER||Percent of subjects with success|31.7||||||95.0|18.08|48.09|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|For sample size calculation, null hypothesis (p\<p0) is defined as response rate \<15% (ie, weak drug efficacy). Alternative hypothesis (p\>pA) defined as response rate \>30%. To reduce the chance of incorrectly rejecting the null hypothesis to 5% (α=5%) and incorrectly rejecting the alternate hypothesis to 20% (β=20%) it was calculated that a sample size of 48 subjects was required. Null hypothesis was rejected (assessing efficacy of study drug) if the number of eligible success was ≥ than n=12.||48.09|18.08|
91605983|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.209|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.16|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.160|<0.0001
91605984|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.104|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.104|<0.0001
91605985|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.183||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.183|0.084|<0.0001
91605986|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.025||0.6974|TWO_SIDED|95.0|-0.04|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.059|-0.040|0.6974
91605987|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.163|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.114|0.213||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.213|0.114|<0.0001
91605988|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0027|TWO_SIDED|95.0|0.026|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.026|0.0027
91605989|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0269|TWO_SIDED|95.0|0.006|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.006|0.0269
91651597|NCT02410252|183194859|OTHER||%|100.0|||||TWO_SIDED|||||There was no statistical analysis conducted on demographic characteristics or baseline surveys|descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses.||||
91651598|NCT02410252|183194859|OTHER|Only percents were calculated, no formal statistical analysis was completed.||||||||||||Statistical analysis was not completed. This was a feasibility study with small n and was not powered to determine statistical significance.||||Only percent will be calculated. No statistical analysis will be conducted.|No statistical analysis was conducted as part of this study.|||
91651599|NCT02410252|183194860|OTHER||%|0.29||||0.13|TWO_SIDED|||||Significance was set at p\<0.05|Cochran-Mantel-Haenszel|||"GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test."||||0.13
91651600|NCT02410252|183194861|OTHER||%|84.0||||0.05|TWO_SIDED||||||descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study||||0.05
91651601|NCT00387712|183194868|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.001||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the primary outcome category (peak fitness) using repeated measures analysis of variance. No adjustment for multiple comparisons is needed.|ANOVA|No other adjustments such as degrees of freedom was necessary.||"Power Calculation: It was calculated that 29 subjects should be randomized to 2 groups to achieve a significant time by group interaction for peak fitness for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.~Primary analyses is a group by time analysis of variance in peak fitness levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points."||||0.001
91651602|NCT00387712|183194869|OTHER|Primary analyses is a group by time analysis of variance in myosin heavy chain levels levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||||0.11|||||||ANOVA|||Power Calculation: It was calculated that 22 participants should be randomized to 2 groups to achieve a significant time by group interaction for myosin heavy chain isoforms for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.||||0.11
91651603|NCT00387712|183194870|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.81||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the secondary outcome category (30 ft walk time - fastest comfortable gait) using repeated measures analysis of variance.|ANOVA|No other adjustments such as degrees of freedom was necessary.||Primary analyses is a group by time analysis of variance in 30 foot walk time (sec) between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||0.81
91651604|NCT00006170|183194871|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.001|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.001
91651605|NCT00006170|183194871|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.25||95.0|||||Regression, Logistic|||||||0.25
91651606|NCT00006170|183194871|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.07||95.0|||||Regression, Logistic|||||||0.07
91709613|NCT04530838|183311599|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|2.06|||||TWO_SIDED|95.0|1.69|2.51||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||2.51|1.69|
91787977|NCT00159822|183456110|SUPERIORITY_OR_OTHER||Percent of subjects with success|33.3||||||95.0|18.6|51.0|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|Month 3 success=yes||51.0|18.6|
91605990|NCT01431287|183104729|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.4343|TWO_SIDED|95.0|-0.03|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.069|-0.030|0.4343
91605991|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.198|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.248||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.248|0.148|<0.0001
91605992|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.146|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.096|0.197||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.197|0.096|<0.0001
91605993|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.158|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.158|<0.0001
91605994|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.143|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.242|0.143|<0.0001
91605995|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.106|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.206|0.106|<0.0001
91787978|NCT00159822|183456110|SUPERIORITY_OR_OTHER||Percent of subjects with success|43.9||||||95.0|28.5|60.3|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|EOT success=yes||60.3|28.5|
91787979|NCT00159822|183456116|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate overall survival|0.85||||||95.0|0.725|0.976|||||Global survival rate calculated using Kaplan-Meier estimate of overall survival.|||0.976|0.725|
91787980|NCT04121078|183456131|EQUIVALENCE|Point estimate and its 90% confidence interval (CI) were calculated for Treatment B to Treatment A ratio of geometric means for Cmax based on the mixed-effect model of log-transformed Cmax with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for Cmax. No adjustments were made for multiplicity.|Geometric Mean Ratio|6.24|||||TWO_SIDED|90.0|4.62|8.42||||||||8.42|4.62|
91605996|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.025||0.698|TWO_SIDED|95.0|-0.06|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.040|-0.060|0.6980
91605997|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.233|0.132|<0.0001
91605998|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.026||0.0442|TWO_SIDED|95.0|0.001|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.001|0.0442
91605999|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.026||0.5514|TWO_SIDED|95.0|-0.035|0.065||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.065|-0.035|0.5514
91606000|NCT01431287|183104730|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1569|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.086|-0.014|0.1569
91606001|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.253||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.253|0.150|<0.0001
91606002|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
91606003|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.218|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.167|0.269||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.269|0.167|<0.0001
91606004|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.181|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.13|0.232||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day\^interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.232|0.130|<0.0001
91606005|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.199|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.25||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.250|0.148|<0.0001
91606006|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.026||0.5373|TWO_SIDED|95.0|-0.067|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.067|0.5373
91651607|NCT00006170|183194872|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.|||||<|0.001||95.0|||||Regression, Logistic|||||||<0.001
91787981|NCT04121078|183456132|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUC∞ based on the mixed-effect model of log-transformed AUC∞ with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUC∞. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.16|||||TWO_SIDED|90.0|4.25|6.25||||||||6.25|4.25|
91651608|NCT00006170|183194872|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.053||95.0|||||Regression, Logistic|||||||0.053
91651609|NCT00006170|183194872|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.08||95.0|||||Regression, Logistic|||||||0.08
91651610|NCT00006170|183194873|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.006||95.0|||||Regression, Logistic|||||||0.006
91606007|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.165|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.216||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.216|0.114|<0.0001
91606008|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.026||0.4763|TWO_SIDED|95.0|-0.033|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.070|-0.033|0.4763
91606009|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1613|TWO_SIDED|95.0|-0.015|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.088|-0.015|0.1613
91606010|NCT01431287|183104731|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.026||0.4908|TWO_SIDED|95.0|-0.069|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.069|0.4908
91606011|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.072|0.173||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.173|0.072|<0.0001
91606012|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.026||0.0154|TWO_SIDED|95.0|0.012|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.012|0.0154
91606013|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.08|0.181||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.181|0.080|<0.0001
91606014|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0012|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.134|0.033|0.0012
91606015|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0061|TWO_SIDED|95.0|0.02|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.020|0.0061
91606016|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.026||0.7518|TWO_SIDED|95.0|-0.059|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.059|0.7518
91606017|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.026||0.0034|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0034
91606018|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0209|TWO_SIDED|95.0|0.009|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.110|0.009|0.0209
91606019|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.026||0.0708|TWO_SIDED|95.0|-0.004|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.004|0.0708
91606020|NCT01431287|183104732|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.026||0.6148|TWO_SIDED|95.0|-0.038|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|-0.038|0.6148
91606021|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.164|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.215||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.215|0.114|<0.0001
91606022|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0064|TWO_SIDED|95.0|0.02|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.020|0.0064
91651611|NCT00006170|183194873|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.45||95.0|||||Regression, Logistic|||||||0.45
91651612|NCT00006170|183194873|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.046||95.0|||||Regression, Logistic|||||||0.046
91651613|NCT00268346|183194885|SUPERIORITY_OR_OTHER||percentage response|6.9|||<|0.05|TWO_SIDED|95.0|||||binomial test for a single proportion|||In patients with prior chemotherapy, \>25% response indicates efficacy and \<10% indicates lack of efficacy. In patients with no prior chemotherapy, \>45% response indicates efficacy and \<25% indicates lack of efficacy. Using a 5% significance level, the study was designed to have 80% power to test each hypothesis.||||<0.05
91651614|NCT00723554|183194931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||<|0.001|TWO_SIDED|95.0|-6.9|-5.4|||t-test, 2 sided|||Comparison of the change in average inhalation times from Period I (PD-6) to Period II (PD-15)||-5.4|-6.9|<0.001
91787982|NCT04121078|183456133|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUClast based on the mixed-effect model of log-transformed AUClast with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUClast. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.21|||||TWO_SIDED|90.0|4.29|6.32||||||||6.32|4.29|
91606023|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.152|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.102|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.102|<0.0001
91606024|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0035|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0035
91606025|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0233|TWO_SIDED|95.0|0.008|0.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.109|0.008|0.0233
91651615|NCT00723554|183194935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.59|TWO_SIDED|95.0|-1.0|0.6|||t-test, 2 sided|||Comparison of the change in average number of days of dosing from Period I (PD-6) to Period II (PD-15)||0.6|-1.0|0.59
91651616|NCT00723554|183194939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7|||t-test, 2 sided|||Comparison of the change in average number of daily doses from Period I (PD-6) to Period II (PD-15)||0.7|0.2|<0.001
91651617|NCT00723554|183194943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.6|||t-test, 2 sided|||Comparison of the change in percentage of complete doses delivered from Period I (PD-6) to Period II (PD-15)||15.6|6.5|<0.0001
91651618|NCT01614509|183194994|NON_INFERIORITY_OR_EQUIVALENCE|Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups||||0.60
91651619|NCT02345486|183195024|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.001|TWO_SIDED|95.0|0.66|0.74|||Wilcoxon (Mann-Whitney)||"reported mean difference is a difference in proportions."|||0.74|0.66|0.001
91651620|NCT03979677|183195049|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Multiple comparisons were adjusted.|linear mixed-effects models|||||||<.0001
91651621|NCT03979677|183195050|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Point change in DHI was tests.|linear mixed-effects models|||||||<.0001
91651622|NCT00415532|183195051|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.172|||<|0.0001||95.0|0.084|0.352||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.352|0.084|<0.0001
91651623|NCT00415532|183195052|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.307||||0.0005||95.0|0.154|0.611||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.611|0.154|0.0005
91606026|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.026||0.6413|TWO_SIDED|95.0|-0.039|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|-0.039|0.6413
91606027|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.026||0.0007|TWO_SIDED|95.0|0.037|0.138||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.138|0.037|0.0007
91606028|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.043|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.144|0.043|0.0003
91606029|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.003|TWO_SIDED|95.0|0.026|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.026|0.0030
91606030|NCT01431287|183104733|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.026||0.5159|TWO_SIDED|95.0|-0.034|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|-0.034|0.5159
91606031|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.159|0.261||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.261|0.159|<0.0001
91606032|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.026||0.0006|TWO_SIDED|95.0|0.038|0.141||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.141|0.038|0.0006
91606033|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
91606034|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.026||0.0094|TWO_SIDED|95.0|0.017|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.017|0.0094
91606035|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.026||0.0174|TWO_SIDED|95.0|0.011|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.011|0.0174
91606036|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.026||0.2888|TWO_SIDED|95.0|-0.023|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|-0.023|0.2888
91606037|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.095|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.146|0.044|0.0003
91651624|NCT00415532|183195055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0133
91787983|NCT02012582|183456162|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||Mixed model analysis for TIL with the patient as random effect and study day, cohort, treatment, and interaction between study day and treatment as fixed effects.|Mixed Models Analysis|||Placebo versus pooled VAS203 Arms/Groups||||<0.04
91651625|NCT00415532|183195056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3434||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.3434
91651626|NCT00415532|183195057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0076||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0076
91651627|NCT00415532|183195058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0246||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0246
91709614|NCT04530838|183311599|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.99|0.73|
91787984|NCT02012582|183456163|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Placebo versus pooled VAS203 Arms/Group||||<0.01
91709615|NCT04530838|183311599|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.74|0.98||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.98|0.74|
91651628|NCT01952574|183195068|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-1.12||||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||-0.17|-2.06|0.021
91651629|NCT01952574|183195068|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-1.07|0.86|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||0.86|-1.07|0.83
91651630|NCT01952574|183195068|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|0.11||||0.82|TWO_SIDED|92.0|-0.83|1.05|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||1.05|-0.83|0.82
91651631|NCT01952574|183195069|SUPERIORITY||Odds Ratio (OR)|2.0||||0.011|TWO_SIDED|95.0|1.17|3.42|||Generalised Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)||3.42|1.17|0.011
91709616|NCT04530838|183311599|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.83|
91709617|NCT04530838|183311599|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
91709618|NCT04530838|183311599|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.98|1.44||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.44|0.98|
91790973|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.132||0.121|TWO_SIDED|95.0|-0.465|0.055||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.055|-0.465|0.121
91651632|NCT01952574|183195069|SUPERIORITY||Odds Ratio (OR)|1.25||||0.44|TWO_SIDED|95.0|0.71|2.18|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)||2.18|0.71|0.44
91651633|NCT01952574|183195069|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.53|1.63|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)||1.63|0.53|0.80
91651634|NCT01952574|183195070|SUPERIORITY||LS Mean Difference|-0.4||||0.13|TWO_SIDED|95.0|-0.92|0.12|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.12|-0.92|0.13
91651635|NCT01952574|183195070|SUPERIORITY||LS Mean Difference|0.02||||0.95|TWO_SIDED|95.0|-0.51|0.54|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.54|-0.51|0.95
91709619|NCT04530838|183311599|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.72|1.21||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.21|0.72|
91709620|NCT04530838|183311599|OTHER||GMR|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.12|0.82|
91709621|NCT04530838|183311599|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.85|
91709622|NCT04530838|183311599|OTHER||GMR|0.87|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.04|0.72|
91709623|NCT04530838|183311599|OTHER||GMR|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.07|0.79|
91709624|NCT04530838|183311599|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.84|
91709625|NCT04530838|183311599|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.10|0.87|
91709626|NCT04530838|183311599|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
91606038|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.07|0.172||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.172|0.070|<0.0001
91606039|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.064|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.166|0.064|<0.0001
91790974|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|1.05|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790975|NCT02880956|183460089|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.136||0.21|TWO_SIDED|95.0|-0.438|0.097||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.097|-0.438|0.210
91606040|NCT01431287|183104734|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.026||0.8241|TWO_SIDED|95.0|-0.045|0.057||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.057|-0.045|0.8241
91606041|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.158|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.208||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.208|0.108|<0.0001
91606042|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.025||0.0048|TWO_SIDED|95.0|0.022|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.022|0.0048
91606043|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.101|0.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.200|0.101|<0.0001
91606044|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.053|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.152|0.053|<0.0001
91606045|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.025||0.0116|TWO_SIDED|95.0|0.014|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.014|0.0116
91606046|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.025||0.7577|TWO_SIDED|95.0|-0.042|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom|spatial power covariance structure for within-patient errors|||0.058|-0.042|0.7577
91709627|NCT04530838|183311599|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.87|
91709628|NCT04530838|183311599|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.73|1.2||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.73|
91787985|NCT02412488|183456182|OTHER|"The goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision. The target sample size of approximately 200 subjects undergoing Reveal LINQ insertion was selected to ensure that the upper 95% confidence interval would be within 3 percentage points of the point estimate of the untoward event rate assuming the underlying rate was 2%"|Event Rate expressed as a percent|0.0|||||TWO_SIDED|95.0|0.0|2.1|||||The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage|"There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision."||2.1|0|
91651636|NCT01952574|183195070|SUPERIORITY||LS Mean Difference|0.37||||0.16|TWO_SIDED|95.0|-0.14|0.87|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.87|-0.14|0.16
91651637|NCT01271933|183195098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|TWO_SIDED|||||The p-value was calculated using log-rank test for comparing pregabalin CR with placebo|Log Rank|||||||0.0186
91651638|NCT01271933|183195102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.41||0.331|TWO_SIDED|95.0|-1.2|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||||0.4|-1.2|0.3310
91651639|NCT01271933|183195105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9247|TWO_SIDED|95.0|-0.8|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.8|-0.8|0.9247
91651640|NCT01271933|183195114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|7.12||0.4314|TWO_SIDED|95.0|-19.7|8.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: Subjective Wake after Sleep Onset||8.5|-19.7|0.4314
91651641|NCT01271933|183195114|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|9.26||0.8915|TWO_SIDED|95.0|-17.1|19.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Subjective Latency to Sleep Onset||19.6|-17.1|0.8915
91709629|NCT04530838|183311599|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.06|0.81|
91787986|NCT00816023|183456189|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Jonckheere-Terpstra|||||||0.474
91787987|NCT01616693|183456208|SUPERIORITY||Difference in seroconversion proportion|4.4|||||TWO_SIDED|97.5|-4.4|13.2||||||||13.2|-4.4|
91787988|NCT01616693|183456208|SUPERIORITY||Difference in seroconversion proportion|7.5|||||TWO_SIDED|95.0|-1.4|16.2||||||||16.2|-1.4|
91651642|NCT01271933|183195115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.41||0.4571|TWO_SIDED|95.0|-0.5|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.5|0.4571
91651643|NCT01271933|183195116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3779|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3779
91651644|NCT01271933|183195117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.2009|TWO_SIDED|95.0|-0.2|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.2|0.2009
91651645|NCT01271933|183195119|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.1845|TWO_SIDED|95.0|-1.6|0.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.3|-1.6|0.1845
91651646|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.52||0.0305|TWO_SIDED|95.0|-18.9|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep disturbance||1.0|-18.9|0.0305
91651647|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.17||0.3133|TWO_SIDED|95.0|-5.0|15.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Snoring||15.5|-5.0|0.3133
91651648|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.71||0.2985|TWO_SIDED|95.0|-11.2|3.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Awakening Short of Breath or with a Headache||3.5|-11.2|0.2985
91651649|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.49||0.2159|TWO_SIDED|95.0|-4.1|17.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep adequacy||17.7|-4.1|0.2159
91651650|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|4.1||0.2041|TWO_SIDED|95.0|-13.4|2.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Somnolence||2.9|-13.4|0.2041
91651651|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.81||0.1319|TWO_SIDED|95.0|-13.4|1.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index I||1.8|-13.4|0.1319
91709630|NCT04530838|183311599|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.71|
91787989|NCT01616693|183456208|SUPERIORITY||Difference in seroconversion proportion|12.0|||||TWO_SIDED|95.0|0.8|22.8||||||||22.8|.8|
91787990|NCT01616693|183456210|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-4.3|6.6||||||||6.6|-4.3|
91651652|NCT01271933|183195122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|3.89||0.1473|TWO_SIDED|95.0|-13.4|2.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index II||2.0|-13.4|0.1473
91651653|NCT01271933|183195123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3596|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3596
91651654|NCT01271933|183195125|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.4985|TWO_SIDED|95.0|0.66|2.36||Nominal p-value for two-sided test.|two-sided test|||"Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.~Odds ratio \> 1 is in favor of Pregabalin 330 - 495 mg/day."||2.36|0.66|0.4985
91651655|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.1||0.74|TWO_SIDED|95.0|-9.5|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Physical Functioning||6.8|-9.5|0.7400
91651656|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.89||0.5938|TWO_SIDED|95.0|-7.1|12.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Physical||12.3|-7.1|0.5938
91651657|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|4.61||0.4842|TWO_SIDED|95.0|-5.9|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Pain Index||12.4|-5.9|0.4842
91651658|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.45||0.0827|TWO_SIDED|95.0|-12.9|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: SF-36 General Health Perceptions||0.8|-12.9|0.0827
91709631|NCT04530838|183311599|OTHER||GMR|1.0|||||TWO_SIDED|95.0|0.85|1.18||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.18|0.85|
91651659|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|4.73||0.4561|TWO_SIDED|95.0|-12.09|5.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Vitality||5.8|-12.09|0.4561
91651660|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|4.31||0.9645|TWO_SIDED|95.0|-8.8|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Social Functioning||8.4|-8.8|0.9645
91651661|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|5.41||0.7636|TWO_SIDED|95.0|-9.1|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Emotional||12.4|-9.1|0.7636
91651662|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.54||0.7067|TWO_SIDED|95.0|-5.7|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Mental Health Index||8.4|-5.7|0.7067
91651663|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.8352|TWO_SIDED|95.0|-3.9|3.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Component Score||3.2|-3.9|0.8352
91651664|NCT01271933|183195127|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.22||0.9347|TWO_SIDED|95.0|-4.2|4.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental Component Score||4.6|-4.2|0.9347
91651665|NCT01271933|183195129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1901|TWO_SIDED|95.0|-0.5|2.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-A Anxiety scale||2.3|-0.5|0.1901
91651666|NCT01271933|183195129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.6914|TWO_SIDED|95.0|-1.6|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-D Depression scale||1.0|-1.6|0.6914
91651667|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.41||0.3721|TWO_SIDED|95.0|-0.5|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 1: Physical activities||1.2|-0.5|0.3721
91651668|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.8084|TWO_SIDED|95.0|-1.1|1.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 2: Feel good||1.4|-1.1|0.8084
91651669|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6312|TWO_SIDED|95.0|-0.9|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 3: Work missed||0.5|-0.9|0.6312
91651670|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.8824|TWO_SIDED|95.0|-1.0|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 4: Do job||1.2|-1.0|0.8824
91709632|NCT04530838|183311599|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.02|0.78|
91787991|NCT01616693|183456210|SUPERIORITY||Mean Difference (Net)|-3.1|||||TWO_SIDED|95.0|-8.6|2.3||||||||2.3|-8.6|
91787992|NCT01616693|183456210|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-9.8|5.7||||||||5.7|-9.8|
91787993|NCT00441116|183456214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.54|STANDARD_DEVIATION|20.37||0.0319||95.0|0.75|14.33|||t-test, 2 sided||Mean difference = Drug A minus Drug B|Month 6 - Baseline||14.33|0.75|0.0319
91651671|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2742|TWO_SIDED|95.0|-1.5|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 5: Pain||0.4|-1.5|0.2742
91651672|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.852|TWO_SIDED|95.0|-0.8|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 6: Fatigue||1.0|-0.8|0.8520
91651673|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5264|TWO_SIDED|95.0|-1.4|0.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 7: Rested||0.7|-1.4|0.5264
91651674|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6601|TWO_SIDED|95.0|-1.3|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 8: Stiffness||0.9|-1.3|0.6601
91651675|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8937|TWO_SIDED|95.0|-1.2|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 9: Anxiety||1.0|-1.2|0.8937
91651676|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.9151|TWO_SIDED|95.0|-1.0|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 10: Depression||0.9|-1.0|0.9151
91651677|NCT01271933|183195131|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|3.91||0.9045|TWO_SIDED|95.0|-8.2|7.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the total score||7.3|-8.2|0.9045
91651678|NCT01271933|183195133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.4606|TWO_SIDED|95.0|-0.4|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: General Fatigue||0.9|-0.4|0.4606
91651679|NCT01271933|183195133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.37||0.4703|TWO_SIDED|95.0|-1.0|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Fatigue||0.5|-1.0|0.4703
91651680|NCT01271933|183195133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4009|TWO_SIDED|95.0|-0.4|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced activity||1.0|-0.4|0.4009
91651681|NCT01271933|183195133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.35||0.0695|TWO_SIDED|95.0|-0.1|1.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced motivation||1.3|-0.1|0.0695
91787994|NCT01332461|183456286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649||||0.05|TWO_SIDED|95.0|0.455|0.926|||Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.926|0.455|0.05
91651682|NCT01271933|183195133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.5869|TWO_SIDED|95.0|-0.7|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental fatigue||0.4|-0.7|0.5869
91651683|NCT01271933|183195135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.0296|TWO_SIDED|95.0|1.09|4.81||Nominal p-value for two-sided test.|two-sided test|||This analysis is for the domain: Benefit from treatment||4.81|1.09|0.0296
91651684|NCT01271933|183195135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.4691|TWO_SIDED|95.0|0.64|2.61||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Satisfaction from treatment||2.61|0.64|0.4691
91651685|NCT01271933|183195135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9577|TWO_SIDED|95.0|0.48|2.01||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Willingness to continue treatment||2.01|0.48|0.9577
91651686|NCT01271933|183195137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|STANDARD_ERROR_OF_MEAN|9.85||0.0562|TWO_SIDED|95.0|-0.5|39.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Work Time Missed||39.2|-0.5|0.0562
91787995|NCT01332461|183456287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601|||<|0.05|TWO_SIDED|95.0|0.326|1.109||COPD-related hospitalization|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.109|0.326|<0.05
91787996|NCT01332461|183456287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651|||<|0.05|TWO_SIDED|95.0|0.434|0.977||COPD-related ER visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.977|0.434|<0.05
91606047|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.061|0.16||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.160|0.061|<0.0001
91606048|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0007|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.136|0.037|0.0007
91606049|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0621|TWO_SIDED|95.0|-0.002|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.002|0.0621
91606050|NCT01431287|183104735|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.025||0.1266|TWO_SIDED|95.0|-0.011|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.089|-0.011|0.1266
91606051|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.104|0.209||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.209|0.104|<0.0001
91606052|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0013|TWO_SIDED|95.0|0.034|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.139|0.034|0.0013
91651687|NCT01271933|183195137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.96||0.7892|TWO_SIDED|95.0|-7.0|9.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Impairment While Working||9.2|-7.0|0.7892
91651688|NCT01271933|183195137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.82||0.0819|TWO_SIDED|95.0|-0.4|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Activity Impairment||6.8|-0.4|0.0819
91651689|NCT01271933|183195137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.91||0.4135|TWO_SIDED|95.0|-2.2|5.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Overall Work Impairment||5.4|-2.2|0.4135
91651690|NCT01271933|183195148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1224|TWO_SIDED|95.0|-0.1|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.9|-0.1|0.1224
91651691|NCT01271933|183195149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.06||0.768|TWO_SIDED|95.0|-9.3|6.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||6.9|-9.3|0.7680
91651692|NCT01271933|183195150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.136|TWO_SIDED|95.0|-4.5|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-4.5|0.1360
91651693|NCT01271933|183195151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6489.5|STANDARD_ERROR_OF_MEAN|12579.5||0.6077|TWO_SIDED|95.0|-18648.6|31627.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Total daytime activity||31627.6|-18648.6|0.6077
91651694|NCT01271933|183195152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.6647|TWO_SIDED|95.0|-2.2|3.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||3.4|-2.2|0.6647
91651695|NCT00591253|183195166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.001|TWO_SIDED|95.0|-7.97|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.04|-7.97|0.001
91787997|NCT01332461|183456287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.815|||<|0.05|TWO_SIDED|95.0|0.658|1.008||COPD-related physician + Rx visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.008|0.658|<0.05
91787998|NCT01332461|183456287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.785|||<|0.05|TWO_SIDED|95.0|0.649|0.948||COPD-related hospitalization/ER visit/physician+Rx|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.948|0.649|<0.05
91787999|NCT01008423|183456300|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||<0.0001
91606053|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.118|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.223|0.118|<0.0001
91651696|NCT00591253|183195166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-10.69|-4.86||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-4.86|-10.69|<0.001
91651697|NCT00591253|183195167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.48|||<|0.001|TWO_SIDED|95.0|-10.18|-2.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.78|-10.18|<0.001
91651698|NCT00591253|183195167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-10.27|-2.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.81|-10.27|<0.001
91606054|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.027||0.0001|TWO_SIDED|95.0|0.049|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.154|0.049|0.0001
91606055|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.027||0.0002|TWO_SIDED|95.0|0.048|0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.153|0.048|0.0002
91606056|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6093|TWO_SIDED|95.0|-0.066|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.039|-0.066|0.6093
91651699|NCT00591253|183195168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.001|TWO_SIDED|95.0|-5.47|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.40|-5.47|0.001
91651700|NCT00591253|183195168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.77|||<|0.001|TWO_SIDED|95.0|-7.78|-3.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.77|-7.78|<0.001
91651701|NCT00591253|183195169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.004|TWO_SIDED|95.0|-5.22|-1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.02|-5.22|0.004
91651702|NCT00591253|183195169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0.006|TWO_SIDED|95.0|-5.08|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.84|-5.08|0.006
91651703|NCT00591253|183195170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09||||0.001|TWO_SIDED|95.0|-8.14|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.14|0.001
91709633|NCT04530838|183311599|OTHER||GMR|0.95|||||TWO_SIDED|95.0|0.79|1.15||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.79|
91651704|NCT00591253|183195170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.001|TWO_SIDED|95.0|-10.96|-4.97||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.97|-10.96|<0.001
91651705|NCT00591253|183195171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.001|TWO_SIDED|95.0|-5.86|-1.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.61|-5.86|<0.001
91651706|NCT00591253|183195171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.001|TWO_SIDED|95.0|-7.99|-3.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.81|-7.99|<0.001
91651707|NCT00591253|183195172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91||||0.008|TWO_SIDED|95.0|-8.54|-1.27||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.27|-8.54|0.008
91651708|NCT00591253|183195172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||<|0.001|TWO_SIDED|95.0|-10.85|-3.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.69|-10.85|<0.001
91651709|NCT00591253|183195173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05||||0.024|TWO_SIDED|95.0|-5.69|-0.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.40|-5.69|0.024
91709634|NCT02672176|183311606|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91709635|NCT02672176|183311607|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91709636|NCT02672176|183311608|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91709637|NCT02672176|183311609|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91606057|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.035|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.140|0.035|0.0011
91606058|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.0095|TWO_SIDED|95.0|0.017|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.123|0.017|0.0095
91606059|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.027||0.0108|TWO_SIDED|95.0|0.016|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.016|0.0108
91606060|NCT01431287|183104736|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.9627|TWO_SIDED|95.0|-0.051|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|-0.051|0.9627
91606061|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.162|0.074|<0.0001
91651710|NCT00591253|183195173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79|||<|0.001|TWO_SIDED|95.0|-8.39|-3.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.19|-8.39|<0.001
91651711|NCT00591253|183195174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.001|TWO_SIDED|95.0|-8.52|-2.08||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.08|-8.52|0.001
91651712|NCT00591253|183195174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.001|TWO_SIDED|95.0|-10.88|-4.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-10.88|<0.001
91651713|NCT00591253|183195175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81||||0.001|TWO_SIDED|95.0|-6.08|-1.54||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.54|-6.08|0.001
91651714|NCT00591253|183195175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|||<|0.001|TWO_SIDED|95.0|-7.88|-3.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-7.88|<0.001
91651715|NCT00591253|183195176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.86||||0.014|TWO_SIDED|95.0|-8.72|-1.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.01|-8.72|0.014
91651716|NCT00591253|183195176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|||<|0.001|TWO_SIDED|95.0|-12.5|-4.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.92|-12.50|<0.001
91651717|NCT00591253|183195177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04||||0.012|TWO_SIDED|95.0|-7.17|-0.91||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.91|-7.17|0.012
91606062|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.169|0.077|<0.0001
91606063|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.114|0.028|0.0012
91651718|NCT00591253|183195177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-10.63|-4.48||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.48|-10.63|<0.001
91651719|NCT00591253|183195178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.004|TWO_SIDED|95.0|1.27|3.65||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.65|1.27|0.004
91651720|NCT00591253|183195178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.016|TWO_SIDED|95.0|1.13|3.31||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.31|1.13|0.016
91790976|NCT02880956|183460089|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91651721|NCT00591253|183195179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.018|TWO_SIDED|95.0|1.11|3.08||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.08|1.11|0.018
91651722|NCT00591253|183195179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.015|TWO_SIDED|95.0|1.13|3.16||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.16|1.13|0.015
91606064|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.137|0.050|<0.0001
91606065|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.121|0.031|0.0010
91606066|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|0.003|0.0384
91606067|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.185|0.097|<0.0001
91606068|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.040|-0.049|0.8428
91606069|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.020|-0.065|0.3048
91606070|NCT01431287|183104737|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.063|-0.027|0.4311
91606071|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.139|0.057|<0.0001
91606072|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.149|0.063|<0.0001
91606073|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.091|0.010|0.0136
91709638|NCT02672176|183311610|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91606074|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.116|0.035|0.0003
91606075|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.101|0.016|0.0065
91606076|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.089|0.005|0.0277
91606077|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.164|0.081|<0.0001
91606078|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.049|0.7116
91606079|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.016|-0.065|0.2332
91606080|NCT01431287|183104738|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.059|-0.025|0.4374
91606081|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.244|0.077|0.0002
91606082|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.228|0.053|0.0017
91606083|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.210|0.046|0.0022
91606084|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.259|0.093|<0.0001
91606085|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.194|0.022|0.0141
91606086|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.118|-0.053|0.4581
91606087|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.293|0.124|<0.0001
91606088|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.105|-0.064|0.6335
91606089|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.129|0.2530
91709639|NCT02672176|183311611|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91709640|NCT02672176|183311612|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91606090|NCT01431287|183104739|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.153|-0.017|0.1188
91606091|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.217|0.057|0.0008
91606092|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.209|0.042|0.0032
91606093|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.183|0.027|0.0085
91606094|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.235|0.077|0.0001
91606095|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.176|0.011|0.0255
91606096|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.113|-0.049|0.4393
91606097|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.269|0.108|<0.0001
91606098|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|-0.069|0.7784
91606099|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.026|-0.129|0.1965
91651723|NCT00591253|183195180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.31|4.24||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.24|1.31|0.004
91651724|NCT00591253|183195180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|1.57|5.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.13|1.57|<0.001
91606100|NCT01431287|183104740|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.144|-0.019|0.1315
91606101|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-1.043|-3.239|0.0001
91606102|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.230|0.0435
91606103|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.432|-2.623|0.0063
91606104|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.577|-1.611|0.3545
91606105|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.578|-1.614|0.3542
91606106|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.476|-1.702|0.2697
91606107|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.227|0.0434
91709641|NCT02672176|183311613|EQUIVALENCE|Information in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91606108|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.095|-2.114|0.0732
91606109|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.092|-2.114|0.0724
91606110|NCT01431287|183104741|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.104|-1.102|0.9983
91606111|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.718|-2.985|0.0014
91606112|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.686|-1.573|0.4413
91606113|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.304|-2.569|0.0129
91606114|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.070|-1.182|0.9222
91606115|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.100|-1.157|0.9602
91606116|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|-1.533|0.4669
91606117|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.656|-1.598|0.4126
91606118|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.265|-2.551|0.0158
91606119|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.240|-2.521|0.0177
91651725|NCT00362401|183195181|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.||||<0.05
91651726|NCT01841359|183195198|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
91651727|NCT01841359|183195199|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
91651728|NCT01841359|183195200|OTHER||||||=|0.20492|||||||t-test, 2 sided|||||||= 0.20492
91651729|NCT01841359|183195201|OTHER|||||||0.2655|||||||t-test, 2 sided|||||||0.2655
91651730|NCT01841359|183195202|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91651731|NCT01841359|183195203|OTHER|||||||0.597|||||||t-test, 2 sided|||||||0.597
91651732|NCT01841359|183195204|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
91651733|NCT01841359|183195205|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
91651734|NCT01841359|183195206|OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
91651735|NCT01841359|183195207|OTHER|||||||0.89|||||||t-test, 2 sided|||||||0.890
91606120|NCT01431287|183104742|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.109|-1.164|0.9624
91606121|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.862|0.329|<0.0001
91606122|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.907|0.373|<0.0001
91606123|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.690|0.156|0.0019
91606124|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.712|0.179|0.0011
91606125|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.735|0.201|0.0006
91606126|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.438|-0.094|0.2045
91606127|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.885|0.351|<0.0001
91606128|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.223|-0.313|0.7432
91651736|NCT01841359|183195208|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
91651737|NCT00252187|183195211|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||Change in end systolic LV volume index compared between two groups||||0.004
91651738|NCT00252187|183195211|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Change in LV end diastolic volume was compared between two groups||||0.001
91651739|NCT00252187|183195212|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
91651740|NCT00252187|183195214|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
91651741|NCT00252187|183195215|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
91651742|NCT03764059|183195219|NON_INFERIORITY|The test for non-inferiority is based on a 95% CI of the difference between the investigational and control groups with respect to the rate of clinically acceptable restorations at 1-year post placement. The non-inferiority margin was 7%. To establish non-inferiority the lower limit has to be \> -7%|Risk Difference (RD)|4.2|||<|0.0001|TWO_SIDED|95.0||9.2|||Cochran-Mantel-Haenszel|||||9.2|- 0.6|< 0.0001
91651743|NCT00769015|183195232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.54||||0.067|TWO_SIDED|95.0|0.27|1.06||Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.|Mantel Haenszel|||||1.06|.27|.067
91651744|NCT00769015|183195233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.75|TWO_SIDED|95.0|-5.92|4.3|||Linear Mixed effects model|||||4.30|-5.92|.75
91651745|NCT00769015|183195234|SUPERIORITY_OR_OTHER||Change in least squares mean|3.47||||0.68|TWO_SIDED|95.0|-12.22|5.29|||Mixed Models Analysis|||||5.29|-12.22|.68
91651746|NCT00769015|183195235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42||||0.34|TWO_SIDED|95.0|-2.58|7.41|||Least squares mean|||||7.41|-2.58|.34
91651747|NCT00769015|183195236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.68|TWO_SIDED|95.0|-9.8|5.76|||Least squares mean|||||5.76|-9.80|.68
91651748|NCT00769015|183195237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.68|TWO_SIDED|95.0|-4.04|6.82|||Least squares mean|||||6.82|-4.04|.68
91651749|NCT00769015|183195238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.68|TWO_SIDED|95.0|-5.94|9.17|||Least squares mean|||||9.17|-5.94|.68
91651750|NCT00947765|183195242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91651751|NCT00947765|183195243|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91606129|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.245|-0.290|0.8687
91606130|NCT01431287|183104743|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.246|-0.290|0.8709
91606131|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.898|0.362|<0.0001
91606132|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|0.166|0.0015
91606133|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.687|0.151|0.0022
91606134|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.495|-0.041|0.0966
91606135|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.492|-0.045|0.1029
91606136|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.478|-0.056|0.1220
91606137|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.707|0.170|0.0014
91606138|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.465|-0.074|0.1542
91651752|NCT00947765|183195244|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0022
91651753|NCT00947765|183195245|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
91606139|NCT01431287|183104744|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.461|-0.077|0.1626
91606140|NCT01431287|183104744|SUPERIORITY_OR_OTHER||djusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.274|-0.265|0.9765
91606141|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.925|0.370|<0.0001
91651754|NCT00947765|183195246|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
91651755|NCT00947765|183195247|SUPERIORITY_OR_OTHER|||||||0.0184||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0184
91651756|NCT00947765|183195248|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0058
91651757|NCT00947765|183195249|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0064
91790977|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.188||0.303|TWO_SIDED|95.0|-0.564|0.176||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.176|-0.564|0.303
91790978|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790979|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.186||0.358|TWO_SIDED|95.0|-0.536|0.194||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.194|-0.536|0.358
91606142|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.600|0.045|0.0226
91606143|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.649|0.093|0.0089
91606144|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.609|0.056|0.0186
91606145|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.324|-0.231|0.7441
91606146|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.551|0.001|0.0492
91606147|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.884|0.332|<0.0001
91606148|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.605|0.045|0.0230
91651758|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|2.151|||TWO_SIDED|90.0|2.72|9.89|||||Confidence interval (CI), estimated value and dispersion value of is presented for pre dose|||9.89|2.72|
91651759|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.43|STANDARD_ERROR_OF_MEAN|2.059|||TWO_SIDED|90.0|3.0|9.87|||||CI, estimated value and dispersion value of is presented for 1 hour post dose|||9.87|3.00|
91651760|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.71|STANDARD_ERROR_OF_MEAN|1.734|||TWO_SIDED|90.0|4.82|10.6|||||CI, estimated value and dispersion value of is presented for 2 hour post dose|||10.60|4.82|
91651761|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.42|STANDARD_ERROR_OF_MEAN|2.085|||TWO_SIDED|90.0|2.94|9.89|||||CI, estimated value and dispersion value of is presented for 3 hour post dose|||9.89|2.94|
91651762|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|90.0|2.54|10.65|||||CI, estimated value and dispersion value of is presented for 4 hour post dose|||10.65|2.54|
91651763|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|2.573|||TWO_SIDED|90.0|1.57|10.14|||||CI, estimated value and dispersion value of is presented for 6 hour post dose|||10.14|1.57|
91651764|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|2.735|||TWO_SIDED|90.0|0.35|9.47|||||CI, estimated value and dispersion value of is presented for 8 hour post dose|||9.47|0.35|
91651765|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.75|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|90.0|4.08|13.42|||||CI, estimated value and dispersion value of is presented for 10 hour post dose|||13.42|4.08|
91790980|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91790981|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.347|TWO_SIDED|95.0|-0.553|0.195||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.195|-0.553|0.347
91651766|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|2.759|||TWO_SIDED|90.0|1.16|10.36|||||CI, estimated value and dispersion value of is presented for 12 hour post dose|||10.36|1.16|
91651767|NCT01328054|183195250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.164|||TWO_SIDED|90.0|0.15|7.36|||||CI, estimated value and dispersion value of is presented for 24 hour post dose|||7.36|0.15|
91606149|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.317|-0.240|0.7855
91606150|NCT01431287|183104745|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.564|0.007|0.0442
91606151|NCT02240134|183104759|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.46|3.32|||Mixed Models Analysis||Odds ratio for air filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||3.32|0.46|0.68
91606152|NCT02240134|183104759|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.35|2.72|||Mixed Models Analysis||Odds ratio for filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||2.72|0.35|0.96
91606153|NCT02240134|183104760|SUPERIORITY||percent differences in geometric mean PM|-6.96||||0.25|TWO_SIDED|95.0|-30.5|24.55|||Mixed Models Analysis|||Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||24.55|-30.50|0.250
91606154|NCT02240134|183104760|SUPERIORITY||percent differences in geometric mean PM|11.77||||0.295|TWO_SIDED|95.0|-16.57|49.72||Statistical significance selected as 95% confidence interval of the estimation parameter that excludes the null value, 0.|Mixed Models Analysis||Difference in indoor PM2.5 for education treatment versus placebo.|Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||49.72|-16.57|0.295
91606155|NCT01380899|183104761|SUPERIORITY|IHC analyses revealed intense α-synuclein positive immunostaining in PD patients, showing small nodular deposits from 1 to 2 μm in diameter in the SCL of the epidermis including the epidermal component adjacent to hair follicles, and in cells from PSUs, while control subjects presented null immunoreaction. The α-synuclein inclusions in the two groups of patients were morphologically similar but quantitatively different. These inclusions appeared to be juxtanuclear.|Median Difference (Net)|57.9|STANDARD_DEVIATION|8.85|<|0.01|TWO_SIDED|95.0|44.9|62.6||The presence of alpha-synuclein aggregates expressed as % of cells with inclusions was tested for normality (Shapiro-Wilk test). Then, with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests (software Statistica 7.0 at 95% confidence).|Kruskal-Wallis|The groups were analyzed with Kruskal-Wallis followed by Mann-Whitney U tests.|The expression of the abnormal protein (alpha-synuclein) must be different between the three groups (PD, AP, and control)|The patients were stratified according to the clinical diagnosis made on the basis of the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal a-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test.|The patients were stratified according to the clinical diagnosis based on the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal α-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test. Next, the groups were analyzed with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests. One independent analysis was performed for each structure, namely the epidermis, PSU, and EG. Assessments were performed using the software Statistica 7.0 (Tulsa, OK) at 95% confidence.|62.6|44.9|< 0.01
91606156|NCT00603239|183104769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made (alpha = 0.05).|ANCOVA|No adjustments for multiplicity were made.||Null hypothesis = Change from baseline in HbA1c is equal between the two treatment groups. Greater than 99% power to detect a difference between treatment groups of 0.88% in change in HbA1c from baseline using a 2-sided t-test at a significance level of 0.05.||||<0.001
91651768|NCT03740100|183195274|OTHER||Percent with objective response|17.0|||||TWO_SIDED|95.0|1.0|58.0||||||The primary endpoint was to determine the objective response rate of patients with R/M HNSCC harboring NOTCH1 LOF mutations to oral bimiralisib using RECIST v1.1. We used a Simon's optimal two-stage design. In order to have 80% power to detect a response rate of 30%, (one-sided α=0.05 and β=0.20), we planned to enroll up to 10 patients in the first stage. If ≥ 2 patients had an objective response, then the study would enroll an additional 19 patients in the second stage.||58|1|
91651769|NCT01191255|183195282|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.|ANCOVA|||||||<0.0001
91651770|NCT01191255|183195283|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.|ANCOVA|||||||<0.0001
91709642|NCT02672176|183311614|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91709643|NCT02501161|183311636|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
91790982|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91606157|NCT00603239|183104770|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects with HbA1c \<= 7% is equal between the two treatment groups.||||0.113
91606158|NCT00603239|183104771|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects achieving HbA1c \<= 6.5% is equal between the two treatment groups.||||0.004
91606159|NCT00603239|183104772|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.||||0.009
91606160|NCT00603239|183104773|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.||||0.176
91606161|NCT00603239|183104775|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.||||0.009
91606162|NCT00603239|183104776|SUPERIORITY_OR_OTHER|||||||0.794||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.||||0.794
91606163|NCT00603239|183104777|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments (alpha = 0.05).|Fisher Exact|No adjustment for multiplicity.||Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.||||1.00
91606164|NCT00603239|183104778|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.||||0.342
91606165|NCT00603239|183104779|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||No adjustments (alpha = 0.05)|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.||||0.186
91606166|NCT02210780|183104783|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|24.29|43.75|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||43.75|24.29|<0.0001
91606167|NCT02210780|183104784|SUPERIORITY||Percentage Difference|40.2|||<|0.0001|TWO_SIDED|90.0|29.4|51.01|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||51.01|29.40|<0.0001
91606168|NCT02210780|183104785|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|23.38|44.66|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||44.66|23.38|<0.0001
91606169|NCT02210780|183104786|SUPERIORITY||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|90.0|-2.72|-1.55|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.||-1.55|-2.72|<0.0001
91606170|NCT02210780|183104787|SUPERIORITY||LS Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|90.0|-22.5|-13.1|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.||-13.1|-22.5|<0.0001
91606171|NCT02210780|183104789|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|90.0|-3.0|-1.7|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.||-1.7|-3.0|<0.0001
91606172|NCT02210780|183104790|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|90.0|-9.9|-6.6|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.||-6.6|-9.9|<0.0001
91606173|NCT05127486|183104824|SUPERIORITY||Odds Ratio (OR)|1.06||||0.695|TWO_SIDED|95.0|0.81|1.38|||pseudo likelihood-based repeated measure|||||1.38|0.81|0.695
91606174|NCT05127486|183104825|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.89|1.56|||pseudo likelihood-based repeated measure|||||1.56|0.89|
91606175|NCT05127486|183104826|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.89|1.79|||pseudo likelihood-based repeated measure|||||1.79|0.89|
91606176|NCT05127486|183104827|SUPERIORITY||LS Mean difference|-0.37|||||TWO_SIDED|95.0|-0.82|0.09|||Mixed Models Analysis|||||0.09|-0.82|
91606177|NCT05127486|183104828|SUPERIORITY||LS Mean difference|-0.55|||||TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||||0.00|-1.11|
91709644|NCT02501161|183311637|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
91709645|NCT04336475|183311690|SUPERIORITY|||||||0.564||||||The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)|ANOVA|Repeated Measures ANOVA||||||0.564
91709646|NCT01441245|183311692|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.04
91523428|NCT00856167|182922626|SUPERIORITY||Regression coefficient|-0.6||||0.02|TWO_SIDED|||||Regression coefficient of TCM indicator variable, with change in CFP as the outcome, and controlling for start of treatment values: CFP, depression, gender, age, site|Regression, Linear|||Participants were allocated to one of the two treatments in order to balance baseline CFP, a depression score, age, gender, and site (Tucson or Portland).|"Since some participants could appear in both the 1st and 2nd period, the regression included random effects to account for correlation between measures on the same person.~In the 1st period, participants could either be allocated to TCM or SC, or if their pain scores were below 5, simply assigned to continuing self-care. Comparisons from this period were only between the allocated TCM and SC groups. In the 2nd period, those allocated or assigned to SC in the 1st period could be allocated to TCM or SC, or again assigned to continuing SC if their pain scores were too low. Comparisons from this period were only between the allocated TCM and SC groups."|||0.020
91790983|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.494|TWO_SIDED|95.0|-0.205|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.205|0.494
91523429|NCT01061333|182922629|SUPERIORITY_OR_OTHER||Difference in LS mean|16.22|||<|0.0001|TWO_SIDED|90.0|10.74|21.69||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.69|10.74|<0.0001
91523430|NCT01061333|182922629|SUPERIORITY_OR_OTHER||Difference in LS Mean|15.51||||0.0001|TWO_SIDED|90.0|10.0|21.02||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.02|10.00|0.0001
91523431|NCT01061333|182922629|SUPERIORITY_OR_OTHER||Difference in LS Mean|8.49||||0.0432|TWO_SIDED|90.0|1.78|15.2||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||15.20|1.78|0.0432
91523432|NCT01061333|182922630|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.27||||0.043|TWO_SIDED|90.0|1.05|1.54||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.54|1.05|0.0430
91523433|NCT01061333|182922630|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.41||||0.01|TWO_SIDED|90.0|1.15|1.72||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.72|1.15|0.0100
91523434|NCT01061333|182922630|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.3||||0.086|TWO_SIDED|90.0|1.01|1.67||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.67|1.01|0.0860
91523435|NCT01061333|182922631|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.5|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.50|<0.0001
91606178|NCT05127486|183104829|SUPERIORITY||LS Mean difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|||||0.18|-0.90|
91523436|NCT01061333|182922631|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.49|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.49|<0.0001
91523437|NCT01061333|182922631|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.87||||0.2679|TWO_SIDED|90.0|0.69|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.69|0.2679
91523438|NCT01061333|182922632|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.9||||0.7622|TWO_SIDED|90.0|0.51|1.59||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.59|0.51|0.7622
91523439|NCT01061333|182922632|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.94||||0.8468|TWO_SIDED|90.0|0.53|1.65||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated on log scale||||1.65|0.53|0.8468
91523440|NCT01061333|182922632|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.91||||0.614|TWO_SIDED|90.0|0.65|1.26||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.26|0.65|0.6140
91523441|NCT01061333|182922633|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.67||||0.0006|TWO_SIDED|90.0|0.57|0.8||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.80|0.57|0.0006
91523442|NCT01061333|182922633|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.79||||0.0291|TWO_SIDED|90.0|0.67|0.94||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.94|0.67|0.0291
91790984|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91606179|NCT05127486|183104830|SUPERIORITY||LS Mean difference|-0.18|||||TWO_SIDED|95.0|-0.73|0.37|||Mixed Models Analysis|||||0.37|-0.73|
91606180|NCT05127486|183104831|SUPERIORITY||LS Mean difference|-0.49|||||TWO_SIDED|95.0|-0.86|-0.11|||Mixed Models Analysis|||||-0.11|-0.86|
91523443|NCT01061333|182922633|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.92||||0.3738|TWO_SIDED|90.0|0.77|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.77|0.3738
91523444|NCT01061333|182922634|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.7501||90.0|0.88|1.2||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.20|0.88|0.7501
91523445|NCT01061333|182922634|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.01||||0.941|TWO_SIDED|90.0|0.81|1.25||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.25|0.81|0.9410
91523446|NCT01061333|182922634|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.89||||0.1165|TWO_SIDED|90.0|0.79|1.01||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.01|0.79|0.1165
91523447|NCT01061333|182922635|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.8616|TWO_SIDED|90.0|0.76|1.41||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.41|0.76|0.8616
91523448|NCT01061333|182922635|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.06||||0.7512|TWO_SIDED|90.0|0.77|1.45||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.45|0.77|0.7512
91606181|NCT05127486|183104832|SUPERIORITY||LS Mean difference|4.39|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|95.0|1.42|7.37|||ANCOVA|||Total score||7.37|1.42|
91651771|NCT01191255|183195284|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91606182|NCT05127486|183104832|SUPERIORITY||LS Mean difference|5.24|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|1.9|8.58|||ANCOVA|||RF-R||8.58|1.90|
91651772|NCT01191255|183195285|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91651773|NCT01191255|183195286|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91651774|NCT01715415|183195297|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.|Percentage of Participants with SVR12|96.3|||||TWO_SIDED|95.0|94.1|98.4|||||95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.|With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).||98.4|94.1|
91606183|NCT05127486|183104832|SUPERIORITY||LS Mean difference|3.88|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|1.06|6.71|||ANCOVA|||RF-P||6.71|1.06|
91606184|NCT05127486|183104832|SUPERIORITY||LS Mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-0.08|6.44|||ANCOVA|||EF||6.44|-0.08|
91651775|NCT01715415|183195298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.|Fisher Exact|||||||<0.001
91606185|NCT05127486|183104833|SUPERIORITY||LS Mean difference|-2.43|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-6.94|2.08|||ANCOVA|||||2.08|-6.94|
91651776|NCT01715415|183195299|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.0|||||TWO_SIDED|95.0|93.0|98.9|||||95% CI calculated using the normal approximation to the binomial distribution.|||98.9|93.0|
91606186|NCT00363415|183104835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||<|0.01||95.0|1.27|1.92|||Log Rank|||||1.92|1.27|<0.01
91606187|NCT00363415|183104836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sex: Male|Log Rank|||||||<0.001
91606188|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Sex: Female|Log Rank|||||||0.023
91651777|NCT01715415|183195300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.7|||||TWO_SIDED|95.0|93.6|99.9||||||||99.9|93.6|
91790985|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.156||0.454|TWO_SIDED|95.0|-0.189|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.189|0.454
91790986|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790987|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_DEVIATION|0.16||0.644|TWO_SIDED|95.0|-0.24|0.388||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.388|-0.240|0.644
91523449|NCT01061333|182922635|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.99||||0.9723|TWO_SIDED|90.0|0.72|1.37||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.37|0.72|0.9723
91606189|NCT00363415|183104836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Race: Caucasian.|Log Rank|||||||<0.001
91606190|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for Race: Non-Caucasian.|Log Rank|||||||0.030
91606191|NCT00363415|183104836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.|Log Rank|||||||<0.001
91606192|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.|Log Rank|||||||0.519
91606193|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||P-value for Region: United States.|Log Rank|||||||0.084
91606194|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Region: European Union.|Log Rank|||||||0.001
91606195|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Region: Intercontinental Region.|Log Rank|||||||0.003
91606196|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for LDH (lactate dehydrogenase): \>Upper Limit of Normal.|Log Rank|||||||0.005
91606197|NCT00363415|183104836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Age: \<=65 years.|Log Rank|||||||<0.001
91606198|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Age: \>65 years.|Log Rank|||||||0.013
91606199|NCT00363415|183104836|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Number Metastatic Sites: \<=2.|Log Rank|||||||0.092
91606200|NCT00363415|183104836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Number Metastatic Sites: \>=3.|Log Rank|||||||<0.001
91606201|NCT00363415|183104836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for History of Brain Metastases: No.|Log Rank|||||||<0.001
91523450|NCT01061333|182922636|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.3||||0.1983|TWO_SIDED|90.0|0.92|1.82||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.82|0.92|0.1983
91523451|NCT01061333|182922636|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.57||||0.0872|TWO_SIDED|90.0|1.02|2.42||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||2.42|1.02|0.0872
91523452|NCT01061333|182922636|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.22||||0.2499|TWO_SIDED|90.0|0.91|1.62||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.62|0.91|0.2499
91651778|NCT04578548|183195303|SUPERIORITY||Geometric Mean Difference|-0.91||||0.606|TWO_SIDED|95.0|-4.34|2.64|||Random coefficient regression model|||Based on a random coefficient regression model (linear slope model) on htTKV log-transformed values with time (in weeks) as a continuous variable, treatment, time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||2.64|-4.34|0.606
91651779|NCT04578548|183195305|SUPERIORITY||Least-squares mean difference|-2.31||||0.171|TWO_SIDED|95.0|-5.64|1.02|||Random coefficient regression model|||Least-squares mean difference (95% CI) from a random coefficient regression model (linear slope model) on eGFR values with time (in weeks) as a continuous variable, the time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||1.02|-5.64|0.171
91651780|NCT01379781|183195345|SUPERIORITY||Slope|-6.54||||0.01|TWO_SIDED||||||Mixed Models Analysis|||Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre-randomization assessment and the 6 weeks postpartum session.||||.01
91651781|NCT02247479|183195346|SUPERIORITY||Difference in Adjusted Means|-0.019||||0.8381|TWO_SIDED|95.0|-0.206|0.167|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.167|-0.206|0.8381
91651782|NCT02247479|183195346|SUPERIORITY||Difference in Adjusted Means|0.051||||0.5901|TWO_SIDED|95.0|-0.134|0.236|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.236|-0.134|0.5901
91651783|NCT02247479|183195347|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.935|TWO_SIDED|95.0|-5.2|4.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||4.8|-5.2|0.9350
91651784|NCT02247479|183195347|SUPERIORITY||Difference in Adjusted Means|0.1||||0.9789|TWO_SIDED|95.0|-5.0|5.2|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.2|-5.0|0.9789
91651785|NCT02247479|183195348|SUPERIORITY||Difference in Adjusted Means|0.28||||0.5538|TWO_SIDED|95.0|-0.66|1.22|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.22|-0.66|0.5538
91651786|NCT02247479|183195348|SUPERIORITY||Difference in Adjusted Means|-0.63||||0.2032|TWO_SIDED|95.0|-1.6|0.35|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.35|-1.60|0.2032
91651787|NCT02247479|183195349|SUPERIORITY||Difference in Adjusted Means|1.0||||0.2547|TWO_SIDED|95.0|-0.7|2.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.8|-0.7|0.2547
91651788|NCT02247479|183195349|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.8423|TWO_SIDED|95.0|-1.9|1.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||1.6|-1.9|0.8423
91651789|NCT02247479|183195350|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3248|TWO_SIDED|95.0|0.8|2.2|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||2.2|0.8|0.3248
91651790|NCT02247479|183195350|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7209|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||1.8|0.7|0.7209
91651791|NCT02247479|183195351|SUPERIORITY||Difference in Adjusted Means|0.6||||0.5695|TWO_SIDED|95.0|-1.4|2.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.6|-1.4|0.5695
91651792|NCT02247479|183195351|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7865|TWO_SIDED|95.0|-1.7|2.3|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.3|-1.7|0.7865
91651793|NCT02247479|183195352|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9448|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.7|0.6|0.9448
91651794|NCT02247479|183195352|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8764|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.8|0.6|0.8764
91606202|NCT03193866|183104842|SUPERIORITY||Difference in proportion|1.5|||||TWO_SIDED|95.0|-1.8|4.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.9|-1.8|
91606203|NCT03193866|183104842|SUPERIORITY||Difference in proportion|-0.2|||||TWO_SIDED|95.0|-6.8|6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.5|-6.8|
91606204|NCT03193866|183104842|SUPERIORITY||Difference in proportion|1.3|||||TWO_SIDED|95.0|-1.7|4.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.3|-1.7|
91606205|NCT03193866|183104842|SUPERIORITY||Difference in proportion|-0.9|||||TWO_SIDED|95.0|-4.3|2.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.4|-4.3|
91606206|NCT03193866|183104842|SUPERIORITY||Difference in proportion|1.7|||||TWO_SIDED|95.0|-1.3|4.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|-1.3|
91606207|NCT03193866|183104842|SUPERIORITY||Difference in proportion|0.3|||||TWO_SIDED|95.0|-2.7|3.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.7|
91606208|NCT03193866|183104842|SUPERIORITY||Difference in proportion|1.2|||||TWO_SIDED|95.0|-2.0|4.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.4|-2.0|
91606209|NCT03193866|183104842|SUPERIORITY||Difference in proportion|2.0|||||TWO_SIDED|95.0|-3.2|7.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.1|-3.2|
91606210|NCT03193866|183104843|SUPERIORITY||Difference in proportion|0.7|||||TWO_SIDED|95.0|-7.5|8.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.8|-7.5|
91606211|NCT03193866|183104843|SUPERIORITY||Difference in proportion|-2.9|||||TWO_SIDED|95.0|-18.5|12.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.8|-18.5|
91606212|NCT03193866|183104843|SUPERIORITY||Difference in proportion|-0.1|||||TWO_SIDED|95.0|-8.8|8.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.6|-8.8|
91606213|NCT03193866|183104843|SUPERIORITY||Difference in proportion|-0.5|||||TWO_SIDED|95.0|-8.1|7.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.2|-8.1|
91606214|NCT03193866|183104843|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-5.7|8.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.9|-5.7|
91606215|NCT03193866|183104843|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-4.7|8.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.0|-4.7|
91606216|NCT03193866|183104843|SUPERIORITY||Difference in proportion|0.9|||||TWO_SIDED|95.0|-6.2|7.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.9|-6.2|
91651795|NCT02247479|183195353|SUPERIORITY||Difference in Adjusted Means|5.66||||0.0991|TWO_SIDED|95.0|-1.07|12.38|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||12.38|-1.07|0.0991
91606217|NCT03193866|183104843|SUPERIORITY||Difference in proportion|-1.6|||||TWO_SIDED|95.0|-10.8|7.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.5|-10.8|
91606218|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.5|3.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.5|
91606219|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|95.0|-12.5|3.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-12.5|
91606220|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.5|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-2.5|
91606221|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-4.9|-0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.1|-4.9|
91606222|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.6|1.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.1|-2.6|
91606223|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.2|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.2|
91606224|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-4.0|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.0|
91606225|NCT03193866|183104844|SUPERIORITY||Mean Difference (Net)|2.6|||||TWO_SIDED|95.0|-0.6|5.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.8|-0.6|
91606226|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-2.2|6.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.8|-2.2|
91651796|NCT02247479|183195353|SUPERIORITY||Difference in Adjusted Means|-0.99||||0.7713|TWO_SIDED|95.0|-7.66|5.69|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||5.69|-7.66|0.7713
91651797|NCT02247479|183195354|SUPERIORITY||Difference in Adjusted Means|1.72||||0.6204|TWO_SIDED|95.0|-5.09|8.53|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.53|-5.09|0.6204
91651798|NCT02247479|183195354|SUPERIORITY||Difference in Adjusted Means|1.47||||0.6705|TWO_SIDED|95.0|-5.31|8.25|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.25|-5.31|0.6705
91651799|NCT02247479|183195355|SUPERIORITY||Difference in Adjusted Means|-0.36||||0.7246|TWO_SIDED|95.0|-2.35|1.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.64|-2.35|0.7246
91651800|NCT02247479|183195355|SUPERIORITY||Difference in Adjusted Means|-1.56||||0.1193|TWO_SIDED|95.0|-3.53|0.4|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.40|-3.53|0.1193
91651801|NCT02247479|183195356|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.8659|TWO_SIDED|95.0|-2.84|2.39|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||2.39|-2.84|0.8659
91651802|NCT02247479|183195356|SUPERIORITY||Difference in Adjusted Means|-1.94||||0.1399|TWO_SIDED|95.0|-4.51|0.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.64|-4.51|0.1399
91651803|NCT02247479|183195357|SUPERIORITY||Difference in Adjusted Means|0.99||||0.4855|TWO_SIDED|95.0|-1.79|3.76|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.76|-1.79|0.4855
91651804|NCT02247479|183195357|SUPERIORITY||Difference in Adjusted Means|-1.6||||0.2515|TWO_SIDED|95.0|-4.33|1.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.13|-4.33|0.2515
91651805|NCT02247479|183195358|SUPERIORITY||Difference in Adjusted Means|-0.07||||0.2075|TWO_SIDED|95.0|-0.18|0.04|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.04|-0.18|0.2075
91651806|NCT02247479|183195358|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.1222|TWO_SIDED|95.0|-0.19|0.02|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.02|-0.19|0.1222
91651807|NCT02247479|183195359|SUPERIORITY||Difference in Adjusted Means|-0.022||||0.8612|TWO_SIDED|95.0|-0.266|0.223|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.223|-0.266|0.8612
91651808|NCT02247479|183195359|SUPERIORITY||Difference in Adjusted Means|0.077||||0.5317|TWO_SIDED|95.0|-0.165|0.319|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.319|-0.165|0.5317
91651809|NCT02247479|183195359|SUPERIORITY||Difference in Adjusted Means|-0.033||||0.824|TWO_SIDED|95.0|-0.322|0.257|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.257|-0.322|0.8240
91790988|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|1.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91790989|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.232||0.685|TWO_SIDED|95.0|-0.363|0.551||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.551|-0.363|0.685
91790990|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91606227|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|-8.3|||||TWO_SIDED|95.0|-20.3|3.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.7|-20.3|
91606228|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.6|3.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.5|-2.6|
91606229|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-5.8|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-5.8|
91606230|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.7|-2.9|
91606231|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-4.5|1.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.6|-4.5|
91606232|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-4.7|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-4.7|
91606233|NCT03193866|183104845|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-1.7|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-1.7|
91606234|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.39|||||TWO_SIDED|95.0|0.3|0.48||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.48|0.30|
91606235|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.27|||||TWO_SIDED|95.0|0.11|0.42||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.42|0.11|
91606236|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.17|||||TWO_SIDED|95.0|0.1|0.23||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.23|0.10|
91651810|NCT02247479|183195359|SUPERIORITY||Difference in Adjusted Means|0.006||||0.9676|TWO_SIDED|95.0|-0.283|0.294|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.294|-0.283|0.9676
91651811|NCT01506323|183195444|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.||||<.006
91651812|NCT01506323|183195444|SUPERIORITY_OR_OTHER||repeated measures||||<|0.031|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using false discovery rate.|Mixed Models Analysis|This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.||This analysis is from baseline (week 0) to 2 months follow-up.||||<.031
91651813|NCT01506323|183195445|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||The p-value is based on false discovery rate adjustment for multiple comparisons.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.||||0.82
91651814|NCT01506323|183195445|SUPERIORITY_OR_OTHER|||||||0.82|ONE_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment.||||0.82
91651815|NCT01506323|183195446|SUPERIORITY_OR_OTHER||||||<|0.008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.||||<0.008
91709647|NCT01441245|183311693|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage and compared with chi-square test. p values \<0.05 were considered significant.||||<0.01
91606237|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.05|||||TWO_SIDED|95.0|-0.03|0.13||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.13|-0.03|
91709648|NCT01441245|183311694|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
91606238|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.08|0.19||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.19|0.08|
91606239|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.09|||||TWO_SIDED|95.0|0.01|0.16||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.16|0.01|
91606240|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.06|0.21||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.21|0.06|
91606241|NCT03193866|183104846|SUPERIORITY||Difference in proportion|0.23|||||TWO_SIDED|95.0|0.13|0.33||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.33|0.13|
91606242|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-71.6|||||TWO_SIDED|95.0|-76.6|-66.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-66.6|-76.6|
91651816|NCT01506323|183195446|SUPERIORITY_OR_OTHER||||||<|0.09|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment||||<0.09
91651817|NCT01506323|183195447|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.||||<.006
91709649|NCT01441245|183311695|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
91709650|NCT01441245|183311696|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
91709651|NCT01441245|183311696|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|Risk Ratio (RR)|2.06||||0.01|TWO_SIDED|95.0|1.65|2.57|||Regression, Linear||BNP levels at discharge \>500 pg/ml (RR: 2.06 \[1.65-2.57\];).|||2.57|1.65|0.01
91709652|NCT01441245|183311697|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.03|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.03
91709653|NCT01441245|183311698|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.01
91709654|NCT01441245|183311699|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant||||0.05
91606243|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-66.3|||||TWO_SIDED|95.0|-76.3|-56.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-56.4|-76.3|
91606244|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-47.3|||||TWO_SIDED|95.0|-53.0|-41.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.7|-53.0|
91606245|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-43.1|||||TWO_SIDED|95.0|-49.6|-36.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.6|-49.6|
91651818|NCT01506323|183195447|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to 2 months post-treatment.||||<.03
91651819|NCT01506323|183195448|SUPERIORITY_OR_OTHER||||||<|0.0008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.0008
91651820|NCT01506323|183195448|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Wilcoxon (Mann-Whitney)|||This analysis is from baseline to 2 months post-treatment.||||<0.006
91651821|NCT01506323|183195449|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was \<0.02.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.||||<0.10
91651822|NCT01506323|183195449|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment.||||<0.49
91651823|NCT01506323|183195450|SUPERIORITY_OR_OTHER||||||<|0.78|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.||||<0.78
91709655|NCT01441245|183311700|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage of partecipants and compared with chi-square test. p-value equal or lower than 0.05 are considered statistically significant.||||<0.01
91790991|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.228||0.219|TWO_SIDED|95.0|-0.168|0.73||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.730|-0.168|0.219
91709656|NCT03188523|183311701|SUPERIORITY||Posterior Mean Difference|-1.03|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>98%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
91606246|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-41.3|||||TWO_SIDED|95.0|-46.4|-36.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.2|-46.4|
91606247|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.8|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.8|
91606248|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.7|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.7|
91523453|NCT00871403|182922650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.2647|TWO_SIDED|95.0|0.43|1.28|||Log Rank||The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||1.28|0.43|0.2647
91651824|NCT01506323|183195450|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.99
91651825|NCT01506323|183195451|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.||||<0.04
91651826|NCT01506323|183195451|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.25
91651827|NCT01506323|183195452|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.99
91709657|NCT03188523|183311701|SUPERIORITY||Posterior Mean Difference|-0.92|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>95%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
91651828|NCT01506323|183195452|SUPERIORITY_OR_OTHER||||||<|0.94|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.94
91651829|NCT01506323|183195453|SUPERIORITY_OR_OTHER||||||<|0.12|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.||||<0.12
91651830|NCT01506323|183195453|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.49
91651831|NCT01506323|183195454|SUPERIORITY_OR_OTHER||||||<|0.59|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.||||<0.59
91651832|NCT01506323|183195454|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline to 2-months post-treatment.||||<0.10
91651833|NCT03907280|183195476|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T1/R) [%]|0.5|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|0.39|0.63|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||0.63|0.39|
91651834|NCT03907280|183195476|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T2/R) [%]|40.26|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.68|51.15|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||51.15|31.68|
91651835|NCT03907280|183195476|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T3/R) [%]|40.24|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.86|50.83|||Mixed Models Analysis|The standard error of the mean is actually the geometric standard error.||Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||50.83|31.86|
91651836|NCT02637076|183195496|OTHER|||||||0.31|||||||repeated measures ANOVA|F(2,36)=1.26||||||0.31
91651837|NCT02637076|183195501|OTHER|||||||0.748|||||||repeated measures ANOVA|||||||0.748
91651838|NCT04604184|183195539|OTHER||Risk Difference (RD)|-5.39||||0.3232|TWO_SIDED|95.0|-16.08|5.3|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||5.30|-16.08|0.3232
91709658|NCT03188523|183311717|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
91709659|NCT03188523|183311717|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
91651839|NCT04604184|183195540|OTHER||Risk Difference (RD)|-9.86||||0.1274|TWO_SIDED|95.0|-22.54|2.82|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||2.82|-22.54|0.1274
91651840|NCT04604184|183195541|OTHER||Risk Difference (RD)|2.66||||0.6828|TWO_SIDED|95.0|-10.11|15.43|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||15.43|-10.11|0.6828
91651841|NCT04604184|183195542|OTHER||Rate Ratio|0.67||||0.0445|TWO_SIDED|95.0|0.46|0.99|||Regression, Cox|Covariates are treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalization||||0.99|0.46|0.0445
91651842|NCT04604184|183195543|OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.35||0.5526|TWO_SIDED|95.0|-3.47|1.87|||ANCOVA|Fixed effects of treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalisation as covariates|Difference = covariate adjusted BI 764198 - covariate adjusted Placebo|||1.87|-3.47|0.5526
91651843|NCT04604184|183195544|OTHER||Risk Difference (RD)|5.32||||0.0995|TWO_SIDED|95.0|-1.01|11.65|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 15||11.65|-1.01|0.0995
91651844|NCT04604184|183195544|OTHER||Risk Difference (RD)|6.06||||0.1992|TWO_SIDED|95.0|-3.19|15.31|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 29||15.31|-3.19|0.1992
91651845|NCT04604184|183195544|OTHER||Risk Difference (RD)|8.93||||0.0709|TWO_SIDED|95.0|-0.76|18.62|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 60||18.62|-0.76|0.0709
91651846|NCT04604184|183195544|OTHER||Risk Difference (RD)|10.35||||0.0412|TWO_SIDED|95.0|0.41|20.28|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 90||20.28|0.41|0.0412
91651847|NCT03734237|183195555|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1|Risk Ratio (RR)|-26.7||||0.1412|TWO_SIDED|95.0|-73.7|7.6|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||7.6|-73.7|0.1412
91709660|NCT02179047|183311726|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
91709661|NCT02179047|183311727|SUPERIORITY||Hazard Ratio (HR)|1.05|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
91606249|NCT03193866|183104847|SUPERIORITY||Difference in proportion|-49.8|||||TWO_SIDED|95.0|-58.0|-41.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.6|-58.0|
91606250|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
91651848|NCT03734237|183195555|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1.|Risk Ratio (RR)|-13.1||||0.4552|TWO_SIDED|95.0|-56.4|18.2|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||18.2|-56.4|0.4552
91651849|NCT01844583|183195570|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.14|||||TWO_SIDED|90.0|0.97|1.35|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.35|0.97|
91651850|NCT01844583|183195571|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.08|1.45|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.45|1.08|
91651851|NCT01844583|183195572|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.07|1.53|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.53|1.07|
91651852|NCT01844583|183195575|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.26|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.26|0.84|
91651853|NCT01844583|183195576|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.51|||||TWO_SIDED|90.0|0.41|0.62|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.62|0.41|
91651854|NCT01844583|183195577|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.41|0.7|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.70|0.41|
91651855|NCT01625377|183195583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.34|||<|0.0001|TWO_SIDED|95.0|-21.34|-7.34|||ANCOVA|||||-7.34|-21.34|<0.0001
91651856|NCT03513497|183195596|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91651857|NCT03513497|183195597|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91651858|NCT03513497|183195598|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
91651859|NCT03513497|183195599|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91651860|NCT01412541|183195602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.||||||0.025|||||||Farrington and Manning|||"To assess if proportion of subjects with at least one safety event\* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group."||||0.025
91651861|NCT01412541|183195603|EQUIVALENCE|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test at α=0.05. The response variable in each subject will be the presence or absence of at least one efficacy event from the time following the index procedure through 12 months. The study evaluable sample size required for 90% power is approximately 405 subjects. After adjustment for 15% censoring through 12 months, the study size is 476.||||||0.05|||||||Chi-squared|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test.||"To assess whether the proportion of subjects with at least one efficacy event\* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group."||||0.05
91709662|NCT02179047|183311728|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||ANCOVA|||||||0.001
91709663|NCT01563198|183311748|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)||||<0.0001
91606251|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.4|-0.3|
91606252|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
91606253|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.3|
91606254|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.1|
91606255|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
91606256|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.2|-0.1|
91651862|NCT03294538|183195620|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|-5.8|7.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the primary endpoint was evaluated in the PP population.||7.2|-5.8|
91651863|NCT03294538|183195621|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|19.9|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
91651864|NCT03294538|183195621|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|20.2|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
91651865|NCT03294538|183195622|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|-1.4|||||TWO_SIDED|90.0|-9.0|6.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the secondary endpoint was evaluated in the PP population.||6.2|-9.0|
91709664|NCT01563198|183311749|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91709665|NCT01563198|183311750|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91709666|NCT01703169|183311753|OTHER||||||||||||||||||The proportion of platelet response in a previous study (PMID:22762314) was 0.36 (9/25). The null hypothesis of no difference between the platelet response rate in this study and that of the previous study was tested using a two-sided exact test of binomial proportions. A p-value of 0.40 was obtained. The threshold for significance was 0.05.|||
91709667|NCT00905567|183311758|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|93.01||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
91709668|NCT00905567|183311759|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.62||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
91606257|NCT03193866|183104848|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
91606258|NCT03193866|183104849|SUPERIORITY||Difference in proportion|4.8|||||TWO_SIDED|95.0|-2.2|11.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||11.9|-2.2|
91606259|NCT03193866|183104849|SUPERIORITY||Difference in proportion|9.0|||||TWO_SIDED|95.0|-2.6|20.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||20.6|-2.6|
91606260|NCT03193866|183104849|SUPERIORITY||Difference in proportion|-0.7|||||TWO_SIDED|95.0|-7.6|6.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.2|-7.6|
91606261|NCT03193866|183104849|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-9.4|4.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.1|-9.4|
91709669|NCT00905567|183311760|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.43||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
91651866|NCT03294538|183195623|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|4.9||||0.2897|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the secondary endpoint was evaluated in the mITT population.||||0.2897
91651867|NCT03294538|183195623|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|3.9||||0.4949|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||0.4949
91651868|NCT01787825|183195644|NON_INFERIORITY|This is McNemar design.|percentage concordance|77.19||||1|TWO_SIDED|95.0|68.68|83.93||The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.|McNemar||Overall concordance of clinically significant abnormal images.|There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.||83.93|68.68|1.0000
91651869|NCT01787825|183195646|SUPERIORITY_OR_OTHER||percentage concordance|71.93||||0.972|TWO_SIDED|95.0|63.07|79.36|||Bowkers|||||79.36|63.07|0.972
91651870|NCT02040766|183195698|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.0063|TWO_SIDED|95.0|0.796|4.821||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (inhaled corticosteroid (ICS) or non-corticosteroid (NCS) therapy) at the time of screening visit, during the run-in period, and during treatment.||4.821|0.796|0.0063
91651871|NCT02040766|183195698|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.5332|TWO_SIDED|95.0|-1.354|2.614||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.614|-1.354|0.5332
91709670|NCT02362191|183311765|OTHER|||||||0.758||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.758
91709671|NCT02362191|183311766|OTHER|||||||0.4||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.40
91523454|NCT00871403|182922653|SUPERIORITY_OR_OTHER||percent difference in response|-12.0||||0.2113|TWO_SIDED|95.0|-30.6|7.2|||Binomial asymptotic||The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||7.2|-30.6|0.2113
91606262|NCT03193866|183104849|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-8.6|3.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-8.6|
91606263|NCT03193866|183104849|SUPERIORITY||Difference in proportion|3.8|||||TWO_SIDED|95.0|-4.7|12.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.2|-4.7|
91606264|NCT03193866|183104849|SUPERIORITY||Difference in proportion|0.6|||||TWO_SIDED|95.0|-6.9|8.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.1|-6.9|
91606265|NCT03193866|183104849|SUPERIORITY||Difference in proportion|3.9|||||TWO_SIDED|95.0|-6.3|14.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||14.1|-6.3|
91606266|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-34.1|||||TWO_SIDED|95.0|-40.3|-27.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.9|-40.3|
91651872|NCT02040766|183195698|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.3649|TWO_SIDED|95.0|-1.077|2.924||significance at 0.05|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.924|-1.077|0.3649
91651873|NCT02040766|183195698|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.2823|TWO_SIDED|95.0|-0.902|3.088|||ANCOVA|||||3.088|-0.902|0.2823
91651874|NCT02040766|183195699|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0001|TWO_SIDED|95.0|5.58|17.06|||Mixed Models Analysis|||||17.06|5.58|0.0001
91651875|NCT02040766|183195699|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0041|TWO_SIDED|95.0|2.71|14.24|||Mixed Models Analysis|||||14.24|2.71|0.0041
91651876|NCT02040766|183195699|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.0103|TWO_SIDED|95.0|1.79|13.35|||Mixed Models Analysis|||||13.35|1.79|0.0103
91651877|NCT02040766|183195699|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.0278|TWO_SIDED|95.0|0.71|12.23|||Mixed Models Analysis|||||12.23|0.71|0.0278
91651878|NCT02040766|183195700|SUPERIORITY||Mean Difference (Final Values)|11.7|||<|0.0001|TWO_SIDED|95.0|5.96|17.45|||Mixed Models Analysis|||||17.45|5.96|<0.0001
91651879|NCT02040766|183195700|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.0007|TWO_SIDED|95.0|4.2|15.76|||Mixed Models Analysis|||||15.76|4.20|0.0007
91651880|NCT02040766|183195700|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0008|TWO_SIDED|95.0|4.11|15.68|||Mixed Models Analysis|||||15.68|4.11|0.0008
91790992|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91651881|NCT02040766|183195700|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.0031|TWO_SIDED|95.0|2.95|14.49|||Mixed Models Analysis|||||14.49|2.95|0.0031
91651882|NCT02040766|183195701|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0002|TWO_SIDED|95.0|-0.548|-0.174|||Mixed Models Analysis|||||-0.174|-0.548|0.0002
91651883|NCT02040766|183195701|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.132|TWO_SIDED|95.0|-0.331|0.044|||Mixed Models Analysis|||||0.044|-0.331|0.1320
91651884|NCT02040766|183195701|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.5866|TWO_SIDED|95.0|-0.24|0.136|||Mixed Models Analysis|||||0.136|-0.240|0.5866
91651885|NCT02040766|183195701|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0587|TWO_SIDED|95.0|-0.369|0.007|||Mixed Models Analysis|||||0.007|-0.369|0.0587
91651886|NCT02040766|183195702|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.0011|TWO_SIDED|95.0|-0.261|-0.065|||Mixed Models Analysis|||||-0.065|-0.261|0.0011
91651887|NCT02040766|183195702|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.0869|TWO_SIDED|95.0|-0.185|0.013|||Mixed Models Analysis|||||0.013|-0.185|0.0869
91651888|NCT02040766|183195702|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4388|TWO_SIDED|95.0|-0.138|0.06|||Mixed Models Analysis|||||0.060|-0.138|0.4388
91651889|NCT02040766|183195702|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.1041|TWO_SIDED|95.0|-0.18|0.017|||Mixed Models Analysis|||||0.017|-0.180|0.1041
91651890|NCT02040766|183195703|SUPERIORITY|||||||0.287|||||||Log Rank|||||||0.2870
91651891|NCT02040766|183195703|SUPERIORITY|||||||0.5257|||||||Log Rank|||||||0.5257
91790993|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.232||0.507|TWO_SIDED|95.0|-0.302|0.61||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.610|-0.302|0.507
91606267|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-32.2|||||TWO_SIDED|95.0|-43.0|-21.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-21.5|-43.0|
91606268|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-21.8|||||TWO_SIDED|95.0|-27.9|-15.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-15.7|-27.9|
91606269|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-7.8|||||TWO_SIDED|95.0|-14.5|-1.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.2|-14.5|
91606270|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-23.6|||||TWO_SIDED|95.0|-28.9|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-28.9|
91606271|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-12.7|||||TWO_SIDED|95.0|-18.9|-6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.5|-18.9|
91606272|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-26.5|||||TWO_SIDED|95.0|-32.8|-20.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.2|-32.8|
91606273|NCT03193866|183104850|SUPERIORITY||Difference in proportion|-31.7|||||TWO_SIDED|95.0|-40.1|-23.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-23.2|-40.1|
91651892|NCT02040766|183195703|SUPERIORITY|||||||0.9982|||||||Log Rank|||||||0.9982
91651893|NCT02040766|183195703|SUPERIORITY|||||||0.7633|||||||Log Rank|||||||0.7633
91651894|NCT00617461|183195718|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.29||||0.013|TWO_SIDED|90.0|-0.48|-0.1|||ANCOVA|An ANCOVA (repeated measures mixed model) with body mass index, baseline 24-hr average pain intensity, and grouped center as covariates was used.||||-0.10|-0.48|0.013
91651895|NCT01620489|183195755|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.66|||<|0.0001||95.0|-0.9|-0.43||Adjustment for multiple comparisons was not used since there was only one primary endpoint.|Mixed Models Analysis|||The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR\<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.||-0.43|-0.90|<0.0001
91651896|NCT01620489|183195756|SUPERIORITY_OR_OTHER||Estimated odds ratio|4.48|||<|0.0001||95.0|2.46|8.18||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c and body weight at baseline as covariates. No weight gain was defined as change from baseline to Week 26 in body weight ≤0 kg.||8.18|2.46|<0.0001
91651897|NCT01620489|183195757|SUPERIORITY_OR_OTHER||Estimated odds ratio|3.94|||<|0.0001||95.0|2.12|7.3||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.||7.30|2.12|<0.0001
91651898|NCT01620489|183195758|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.08|||<|0.0001||95.0|-1.58|-0.58||Not adjusted for multiple comparisons|Mixed Models Analysis|||Mean change from baseline in the 7-point profile (SMPG) after 26 weeks treatment was analysed using an MMRM model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.58|-1.58|<0.0001
91790994|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91790995|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.216||0.233|TWO_SIDED|95.0|-0.683|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.167|-0.683|0.233
91606274|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-33.2|||||TWO_SIDED|95.0|-39.4|-27.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.0|-39.4|
91606275|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-30.6|||||TWO_SIDED|95.0|-41.4|-19.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.8|-41.4|
91606276|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-20.8|||||TWO_SIDED|95.0|-27.0|-14.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-14.7|-27.0|
91606277|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-7.0|||||TWO_SIDED|95.0|-13.6|-0.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.3|-13.6|
91606278|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-23.7|||||TWO_SIDED|95.0|-29.2|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-29.2|
91606279|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-12.3|||||TWO_SIDED|95.0|-18.6|-6.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.1|-18.6|
91709672|NCT01473940|183311773|OTHER|||||||||||||P-Value not used||||A 3 + 3 enrollment design was adopted to monitor safety and determine the MTD based on DLTs obsesved. The MTD is the highest dose at which 0 of 3 or 1 of 6 DLTs are detected. The MTD is exceeded if 2 of 3 or 2 of 6 DLTs are detected. There will be no dose escalation within a cohort.|The number of DLTs seen at each cohort were used to determine the MTD for the expansion cohort. The MTD was determined to be Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|||
91523455|NCT03170375|182922663|SUPERIORITY|||||||0.28|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.28
91606280|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-25.3|||||TWO_SIDED|95.0|-31.7|-19.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.0|-31.7|
91606281|NCT03193866|183104851|SUPERIORITY||Difference in proportion|-29.5|||||TWO_SIDED|95.0|-38.2|-20.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.8|-38.2|
91606282|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.07|0.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.00|-0.07|
91606283|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.09|
91790996|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91790997|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.211||0.881|TWO_SIDED|95.0|-0.383|0.446||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.446|-0.383|0.881
91523456|NCT03170375|182922664|SUPERIORITY|||||||0.6|||||||Regression, Linear|adjusted for baseline left ventricular mass index||||||0.60
91606284|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.03|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.03|
91606285|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.05||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.05|-0.03|
91606286|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.04|-0.02|
91651899|NCT01620489|183195759|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.51|||=|0.0022||95.0|-0.83|-0.18|||Mixed Models Analysis|Not adjusted for multiple comparisons||Change from baseline in BMI (kg/m˄2) after 26 weeks treatment was analysed separately using an MMRM analysis model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.18|-0.83|= 0.0022
91651900|NCT01620489|183195760|SUPERIORITY_OR_OTHER||Estimated treatment ratio|0.98|||=|0.3575||95.0|0.94|1.02||Not adjusted for multiple comparisons|Mixed Models Analysis|||The ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 weeks treatment was estimated based on log-transformed data for changes from baseline. The responses were analysed using an MMRM model with treatment, country and stratification groups as fixed effects and log-transformed baseline as a covariate, all nested within visit. The resulting estimates were back-transformed to the original scale.||1.02|0.94|= 0.3575
91651901|NCT02629965|183195769|SUPERIORITY||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.019|<|0.001|TWO_SIDED|95.0|0.077|0.153|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.153|0.077|<0.001
91709673|NCT00534248|183311780|SUPERIORITY_OR_OTHER||point estimate|0.698|||<|0.001|TWO_SIDED|95.0|0.541|0.806|||Conditional Exact Method||The point estimate was for vaccine efficacy with respect to incidence of HZ.|Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.||.806|.541|<.001
91606287|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.01|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.01|
91651902|NCT02629965|183195770|SUPERIORITY||Mean Difference (Final Values)|4.168|STANDARD_ERROR_OF_MEAN|5.26||0.4291|TWO_SIDED|95.0|-6.211|14.548|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|14.548|-6.211|0.4291
91651903|NCT02629965|183195771|SUPERIORITY||Mean Difference (Final Values)|9.501|STANDARD_ERROR_OF_MEAN|83.704||0.9098|TWO_SIDED|95.0|-155.692|174.694|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|174.694|-155.692|0.9098
91651904|NCT02629965|183195772|SUPERIORITY||Mean Difference (Final Values)|-0.292|STANDARD_ERROR_OF_MEAN|0.469||0.5338|TWO_SIDED|95.0|-1.217|0.633|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.633|-1.217|0.5338
91651905|NCT02629965|183195773|SUPERIORITY||Mean Difference (Final Values)|0.939|STANDARD_ERROR_OF_MEAN|1.007||0.3524|TWO_SIDED|95.0|-1.048|2.926|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|2.926|-1.048|0.3524
91709674|NCT00534248|183311781|SUPERIORITY_OR_OTHER||geometric mean titre ratio|2.3|||<|0.001|TWO_SIDED|95.0|2.2|2.4|||linear mixed longitudinal analysis model|||||2.4|2.2|<.001
91709675|NCT00534248|183311782|SUPERIORITY_OR_OTHER||Relative Risk|1.133|||||TWO_SIDED|95.0|0.805|1.595||||||Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.||1.595|.805|
91523457|NCT03170375|182922665|SUPERIORITY|||||||0.27|||||||Regression, Linear|adjusted for baseline global left ventricular longitudinal strain||||||0.27
91523458|NCT03170375|182922666|SUPERIORITY|||||||0.03|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.03
91523459|NCT03170375|182922670|SUPERIORITY|||||||0.47|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.47
91651906|NCT02629965|183195774|SUPERIORITY||Mean Difference (Final Values)|2.257|STANDARD_ERROR_OF_MEAN|2.647||0.3949|TWO_SIDED|95.0|-2.966|7.481|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|7.481|-2.966|0.3949
91651907|NCT02629965|183195775|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_ERROR_OF_MEAN|3.543||0.4955|TWO_SIDED|95.0|-4.572|9.411|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|9.411|-4.572|0.4955
91651908|NCT02629965|183195776|SUPERIORITY||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.091|0.176|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.176|0.091|<0.0001
91651909|NCT02629965|183195777|SUPERIORITY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.088|0.123|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.123|0.088|<0.0001
91651910|NCT02629965|183195778|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.13|0.197|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.197|0.130|<0.0001
91651911|NCT02629965|183195779|SUPERIORITY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.103|0.162|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.162|0.103|<0.0001
91651912|NCT02629965|183195780|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1|0.156|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.156|0.100|<0.0001
91651913|NCT02629965|183195781|SUPERIORITY||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.056|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.056|<0.0001
91651914|NCT02629965|183195782|SUPERIORITY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.058|0.114|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.114|0.058|<0.0001
91651915|NCT02629965|183195783|SUPERIORITY||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.059|<0.0001
91651916|NCT02629965|183195784|SUPERIORITY||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.114|0.189|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.189|0.114|<0.0001
91651917|NCT00634283|183195815|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91709676|NCT02259400|183311791|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of sample size we used the duration of ventilation as the main primary outcome. As no basic data are available for this population, we were able to retrieve from the database of our two NICUs the duration of ventilation on NIV. We assumed a difference of 24-h between the two groups in the duration of NIV as clinically relevant. We used a confidence level α=0.05; the power level desired was 0.80 and consequently we needed 62 patients for each group.|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91523460|NCT03170375|182922671|SUPERIORITY|||||||0.28|||||||generalized estimating equation|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.28
91788000|NCT02034409|183456315|NON_INFERIORITY|For the 48-week OMERACT-OARSI response the minimally clinically significant difference is an absolute rate difference of 10% between sham and PLIUS groups. With a total sample size of 144 the probability of correctly selecting the group with the greatest OORR is at least 0.885 assuming (δ=10%) that the sham group is drawn from a population with a 50% response rate and the PLIUS group is drawn from a population with response rate of at least 60% or at most 40%.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
91790998|NCT02880956|183460090|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91709677|NCT03498313|183311812|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.082||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo represents the reference treatment.|Fixed interaction effect of treatment (0=Placebo, 1=E2) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||-.08|-.41|.002
91709678|NCT03498313|183311812|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.46|TWO_SIDED|95.0|-0.22|0.1|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo Represents the Reference Condition.|Fixed interaction effect of treatment (0=Placebo, 1=P4) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.10|-.22|.46
91790999|NCT02880956|183460090|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.217||0.671|TWO_SIDED|95.0|-0.52|0.335||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.335|-0.520|0.671
91606288|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|0.0|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|0.00|
91606289|NCT03193866|183104852|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.06|
91606290|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.3|5.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.2|-3.3|
91606291|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-9.4|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-9.4|
91606292|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-4.2|1.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.4|-4.2|
91606293|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.9|0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.8|-5.9|
91606294|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.9|2.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.5|-2.9|
91709679|NCT00112918|183311815|SUPERIORITY_OR_OTHER|||||||0.2024||95.0|||||Closed test procedure|||Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.||||0.2024
91606295|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-4.0|
91606296|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-7.0|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-7.0|
91606297|NCT03193866|183104853|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.9|5.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.4|-2.9|
91606298|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|-5.5|||||TWO_SIDED|95.0|-8.1|-2.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-2.9|-8.1|
91606299|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-10.9|-1.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.0|-10.9|
91651918|NCT00634283|183195815|SUPERIORITY|||||||0.32||||||The a priori threshold was set at 0.05, 2-tailed, without adjustment for multiple comparisons.|t-test, 2 sided|||Change in PFC over the one-week placebo lead-in period was compared between antidepressant-experienced and antidepressant-naive groups using a between groups t-test.|"Group differences in PFC changes over time during administration of venlafaxine were assessed using mixed-model analysis.~we compared brain functional changes over the course of venlafaxine treatment between antidepressant-experienced and antidepressant-naïve subjects using linear mixed model analysis (random intercept model) conducted using full maximum likelihood estimation (MLE). Changes in PFC were calculated from the end of placebo lead-in to 48 hours, and 1, 2, and 4 weeks, yielding a within-group factor of time with four levels. We employed a first-order autoregressive covariance structure to reflect our assumption that PFC measurements closer together in time would be more highly correlated."|||0.32
91651919|NCT01743677|183195820|SUPERIORITY||Least Squares Mean Difference|-1.29|||||TWO_SIDED|90.0|-3.15|0.56||||||||0.56|-3.15|
91791000|NCT02880956|183460090|OTHER||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91606300|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.0|-0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.8|-4.0|
91606301|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.1|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-2.1|
91606302|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.2|0.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.6|-2.2|
91606303|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.3|2.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.8|-0.3|
91651920|NCT01743677|183195821|SUPERIORITY||Least Squares Mean Difference|-1.42|||||TWO_SIDED|90.0|-3.28|0.43||||||||0.43|-3.28|
91791001|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.409||0.297|TWO_SIDED|95.0|-1.232|0.377||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.377|-1.232|0.297
91606304|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|0.9|4.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|0.9|
91606305|NCT03193866|183104854|SUPERIORITY||Mean Difference (Final Values)|2.1|||||TWO_SIDED|95.0|0.2|4.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.0|0.2|
91606306|NCT02688647|183104893|SUPERIORITY|||||||0.5733|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL||||0.5733
91606307|NCT02688647|183104893|SUPERIORITY|||||||0.6967|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL||||0.6967
91606308|NCT02688647|183104893|SUPERIORITY|||||||0.5003|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL||||0.5003
91606309|NCT02688647|183104893|SUPERIORITY|||||||0.4866|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)||||0.4866
91606310|NCT02688647|183104896|SUPERIORITY|GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)||||||0.3391|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.3391
91651921|NCT01743677|183195822|SUPERIORITY||Least Squares Mean Difference|-2.29|||||TWO_SIDED|90.0|-4.15|-0.44||||||||-0.44|-4.15|
91651922|NCT01743677|183195823|SUPERIORITY||Least Squares Mean Difference|-1.35|||||TWO_SIDED|90.0|-3.21|0.5||||||||0.50|-3.21|
91651923|NCT01743677|183195824|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-0.78|2.93||||||||2.93|-0.78|
91651924|NCT01743677|183195825|SUPERIORITY||Least Squares Mean Difference|0.86|||||TWO_SIDED|90.0|-1.0|2.71||||||||2.71|-1.00|
91651925|NCT01743677|183195826|SUPERIORITY||Least Squares Mean Difference|1.15|||||TWO_SIDED|90.0|-0.71|3.0||||||||3.00|-0.71|
91606311|NCT02688647|183104896|SUPERIORITY|GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)||||||0.5201|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.5201
91606312|NCT02688647|183104896|SUPERIORITY|GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)||||||0.4426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4426
91606313|NCT02688647|183104896|SUPERIORITY|No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)||||||0.426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4260
91606314|NCT02688647|183104906|SUPERIORITY|Cox Regression||||||0.8561|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.86 (0.16, 4.48)||||0.8561
91606315|NCT02688647|183104906|SUPERIORITY|Cox Regression||||||0.8608|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.87 (95% CI: 0.17, 4.33)||||0.8608
91606316|NCT02688647|183104907|SUPERIORITY|Cox Regression||||||0.0084|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.14, 0.79)||||0.0084
91606317|NCT02688647|183104907|SUPERIORITY|Cox Regression||||||0.0508|TWO_SIDED|95.0|||||Log Rank|||Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)||||0.0508
91606318|NCT02688647|183104909|SUPERIORITY|Cox Regression||||||0.4251|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.02, 5.54)||||0.4251
91606319|NCT02688647|183104909|SUPERIORITY|Cox Regression||||||0.3294|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.27 (95% CI: 0.02, 4.45)||||0.3294
91651926|NCT01743677|183195827|SUPERIORITY||Least Squares Mean Difference|2.15|||||TWO_SIDED|90.0|0.29|4.0||||||||4.00|0.29|
91651927|NCT01743677|183195828|SUPERIORITY||Least Squares Mean Difference|1.35|||||TWO_SIDED|90.0|-0.5|3.21||||||||3.21|-0.50|
91651928|NCT01743677|183195829|SUPERIORITY||Least Squares Mean Difference|11.29|||||TWO_SIDED|90.0|9.62|12.96||||||||12.96|9.62|
91651929|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|0.16|||||TWO_SIDED|90.0|-2.11|2.44||||||0.25 hour post-dose||2.44|-2.11|
91651930|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|1.78|||||TWO_SIDED|90.0|-0.49|4.06||||||0.5 hour post-dose||4.06|-0.49|
91651931|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|2.99|||||TWO_SIDED|90.0|0.71|5.26||||||1 hour post-dose||5.26|0.71|
91651932|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-1.19|3.36||||||2 hours post-dose||3.36|-1.19|
91651933|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|2.16|||||TWO_SIDED|90.0|-0.11|4.44||||||4 hours post-dose||4.44|-0.11|
91651934|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|0.05|||||TWO_SIDED|90.0|-2.22|2.33||||||8 hours post-dose||2.33|-2.22|
91651935|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|0.49|||||TWO_SIDED|90.0|-1.79|2.76||||||12 hours post-dose||2.76|-1.79|
91651936|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.17|4.38||||||16 hours post-dose||4.38|-0.17|
91651937|NCT01743677|183195830|SUPERIORITY||Least Squares Mean Difference|0.79|||||TWO_SIDED|90.0|-1.49|3.06||||||24 hours post-dose||3.06|-1.49|
91606320|NCT03093402|183104928|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-0.9||||0.419|TWO_SIDED|95.0|-2.5|0.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for High JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.6|-2.5|0.4190
91606321|NCT03093402|183104928|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-1.2||||0.419|TWO_SIDED|95.0|-2.7|0.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Medium JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.3|-2.7|0.4190
91606322|NCT03093402|183104928|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Mean Difference (Final Values)|-0.7||||0.419|TWO_SIDED|95.0|-2.2|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Low JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.8|-2.2|0.4190
91606323|NCT03093402|183104938|SUPERIORITY|||||||0.594|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 29.||||0.594
91606324|NCT03093402|183104938|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 57.||||0.487
91606325|NCT03093402|183104938|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 85.||||0.760
91606326|NCT03093402|183104938|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 113.||||0.676
91606327|NCT03093402|183104939|SUPERIORITY|||||||0.796||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.796
91606328|NCT03093402|183104939|SUPERIORITY|||||||0.955||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.955
91606329|NCT03093402|183104939|SUPERIORITY|||||||0.211||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.211
91651938|NCT03586830|183195863|SUPERIORITY||Difference of least square (LS) means|-4.56|STANDARD_ERROR_OF_MEAN|0.757|<|0.001|TWO_SIDED|95.0|-6.05|-3.06|||Hochberg Approach|||||-3.06|-6.05|<.001
91606330|NCT03093402|183104939|SUPERIORITY|||||||0.481||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.481
91651939|NCT03586830|183195863|SUPERIORITY||Difference of LS Means|-5.85|STANDARD_ERROR_OF_MEAN|0.755|<|0.001|TWO_SIDED|95.0|-7.34|-4.36|||Hochberg Approach|||||-4.36|-7.34|<.001
91651940|NCT03586830|183195863|SUPERIORITY||Difference of LS Means|-7.23|STANDARD_ERROR_OF_MEAN|0.748|<|0.001|TWO_SIDED|95.0|-8.7|-5.75|||Hochberg Approach|||||-5.75|-8.70|<.001
91651941|NCT00395083|183195867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||||1.80|0.70|0.62
91788001|NCT02034409|183456316|NON_INFERIORITY|For the 48-week cartilage change outcome measure the minimally clinically significant difference is 33 μm. With a difference of 33 μm, σ=152 μm standard deviation, k=2 groups, and P=0.90 probability to obtain τ=1.8124, which we use to estimate the per-group sample size: n=σ2(τ/δ\*)2=72 or a total of 144.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
91788002|NCT02342418|183456327|SUPERIORITY_OR_OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
91606331|NCT03093402|183104940|SUPERIORITY|||||||0.79||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.790
91606332|NCT03093402|183104940|SUPERIORITY|||||||0.843||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.843
91606333|NCT03093402|183104940|SUPERIORITY|||||||0.637||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.637
91606334|NCT03093402|183104940|SUPERIORITY|||||||0.243||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.243
91651942|NCT00395083|183195868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Regression, Cox|||||1.80|0.70|0.62
91651943|NCT00395083|183195869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.003|TWO_SIDED|95.0|1.46|6.17|||Regression, Cox|||||6.17|1.46|0.003
91651944|NCT00395083|183195870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.002|TWO_SIDED|95.0|1.46|6.17|||Log Rank|||||6.17|1.46|0.002
91651945|NCT04192799|183195871|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.65|0.85||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.85|0.65|<0.001
91651946|NCT04192799|183195872|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.06|1.19||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.19|1.06|<0.001
91788003|NCT02342418|183456328|SUPERIORITY_OR_OTHER|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pair signed-rank test||||0.214
91651947|NCT04192799|183195873|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.93||||0.37|TWO_SIDED|95.0|0.8|1.09||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.09|0.80|0.37
91651948|NCT04192799|183195874|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Odds Ratio (OR)|1.31||||0.81|TWO_SIDED|95.0|0.14|12.27||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Regression, Logistic|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||12.27|0.14|0.81
91788004|NCT00183729|183456335|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study||||0.42
91788005|NCT00183729|183456337|SUPERIORITY|(no comments)|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|7.0||0.06|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.||||0.06
91606335|NCT03093402|183104941|SUPERIORITY||||||>|0.999||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>=100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||>0.999
91606336|NCT03093402|183104941|SUPERIORITY|||||||0.861||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.861
91606337|NCT03093402|183104942|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.39|TWO_SIDED|95.0|-4.8|8.7||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for High JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.7|-4.8|0.390
91651949|NCT04192799|183195875|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Slope|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.11|||Regression, Linear|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.11|-0.01|0.12
91709680|NCT00828061|183311842|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.25||||0.002||95.0|0.12|0.54||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.54|0.12|0.002
91606338|NCT03093402|183104942|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.39|TWO_SIDED|95.0|-4.9|8.2||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Medium JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.2|-4.9|0.390
91606339|NCT03093402|183104942|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.39|TWO_SIDED|95.0|-8.6|4.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Low JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||4.6|-8.6|0.390
91606340|NCT03093402|183104943|SUPERIORITY||Median Difference (Final Values)|0.7||||0.556|TWO_SIDED|95.0|-1.6|3.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||3.0|-1.6|0.556
91606341|NCT03093402|183104943|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.556|TWO_SIDED|95.0|-2.5|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each JBT-101 cohort versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for Medium JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||2.0|-2.5|0.556
91606342|NCT03093402|183104943|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.556|TWO_SIDED|95.0|-3.1|1.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||1.4|-3.1|0.556
91606343|NCT03093402|183104944|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||0.669
91651950|NCT00982410|183195902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6489|STANDARD_ERROR_OF_MEAN|0.29|<|0.05|TWO_SIDED|95.0|-1.2255|-0.0722|||Mixed Models Analysis|Adjusted for baseline NRS-1 pain level. Time interval and therapy session block were utilized to model the variance.|EUC (Arm 2) was referent. Estimation parameter = value for Cognitive Behavior Treatment group minus value for Educational Support group.|Ho: There was no difference in average pain level across the follow-up period, between CBT group and Educational support group.||-0.07220|-1.2255|<0.05
91651951|NCT00982410|183195903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.05|TWO_SIDED|95.0|0.034|0.466|||Mixed Models Analysis|Adjusted for baseline WHY MPI General Activity score. Time interval and therapy session block were utilized to model the variance.|Education Support group was referent. Mean difference = value for CBT group minus value for Educational Support group.|||0.466|0.034|<0.05
91651952|NCT00982410|183195904|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days of alcohol use. Time interval and therapy session block were utilized to model the variance.||||||<0.01
91651953|NCT00982410|183195905|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days illicit drug use. Time interval and therapy session block were utilized to model the variance. EUC group was referent.||||||>0.05
91651954|NCT00982410|183195906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.66|||>|0.05|TWO_SIDED|95.0|-5.0|14.32|||Mixed Models Analysis|Adjusted for baseline pain tolerance. Time interval and therapy session block were utilized to model the variance.|Educational Support group = referent. Estimation parameter = CBT group minus EUC group, adjusted for BL pain tolerance. Cold tolerance distribution had ceiling and floor effects; and, \~20% of participants refused cold tolerance task in follow-up.|||14.32|-5.00|>0.05
91651955|NCT00982410|183195907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.28|||<|0.005|TWO_SIDED|95.0|3.93|16.63|||Mixed Models Analysis|Adjusted for baseline CPSS PSE score. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|Adjusted for baseline CPSS PSE score. EUC group was referent. Mean difference = value for CBT minus value for Educational Support group.|||16.63|3.93|<0.005
91651956|NCT01016652|183195911|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis, with \>=5 CLUE points being the non-inferiority margin.|Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-9.86|1.59|||Mixed Models Analysis|||"Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense."||1.59|-9.86|
91651957|NCT01016652|183195912|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin will be exceeded if the test lens is greater than or equal to 0.25D over the control lens.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.09|0.1|||Mixed Models Analysis|||"Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens"||0.10|-0.09|
91523461|NCT03170375|182922672|SUPERIORITY|||||||0.43|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.43
91651958|NCT02034799|183195917|NON_INFERIORITY_OR_EQUIVALENCE|The assumed proportion of success for SOC is 0.95 and the proportion of success for the Bioseal group at which the power is calculated is 0.95. A sample size of 112 subjects per group achieves 80% power to detect the non-inferiority margin difference between the group proportions of -0.10. One-sided significance level of 0.025 was used. Using drop-out rate of 10%, 125 subjects per treatment group were randomized for a total of 250 subjects.|Risk Difference (RD)|0.0781|||||TWO_SIDED|95.0|-0.048|0.199||||||H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application||0.199|-0.048|
91709681|NCT00828061|183311842|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.07|||<|0.001||95.0|0.03|0.15||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.15|0.03|<0.001
91651959|NCT05188521|183195959|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91651960|NCT05188521|183195960|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
91651961|NCT05188521|183195961|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91651962|NCT05188521|183195962|SUPERIORITY|||||||0.138|||||||Wilcoxon (Mann-Whitney)|||||||0.138
91651963|NCT05188521|183195963|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91651964|NCT05188521|183195964|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
91651965|NCT05188521|183195965|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91523462|NCT03170375|182922673|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
91651966|NCT05188521|183195966|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91651967|NCT01341639|183195969|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|11.37|||<|0.001|TWO_SIDED|95.0|8.44|14.68||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRP|PR5I minus INFANRIX™ hexa|14.68|8.44|< 0.001
91651968|NCT01341639|183195969|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.95|0.96||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Diphtheria|PR5I minus INFANRIX™ hexa|0.96|-0.95|< 0.001
91651969|NCT01341639|183195969|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.71|0.74|||Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Tetanus|PR5I minus INFANRIX™ hexa|0.74|-0.71|< 0.001
91709682|NCT00828061|183311843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.537||95.0|-15.48|17.26||1-sided, alpha = 0.05|ANOVA|||||17.26|-15.48|0.537
91709683|NCT01461473|183311849|SUPERIORITY_OR_OTHER|||||||0.2067|||||||Analysis of covariance (GLM)|||These data were analyzed using an analysis of covariance via general linear model (GLM). The GLM has an indicator variable for PAP vs. OA plus covariates for baseline apnea-hypopnea index, gender, site and baseline NMAP. The primary hypothesis tested is that the 2-month means differ between study arms, after adjustment for the above covariates. A Wald statistic was constructed for hypothesis testing.||||0.2067
91606344|NCT03093402|183104944|SUPERIORITY|||||||0.432|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||0.432
91606345|NCT03093402|183104944|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||0.780
91651970|NCT01341639|183195969|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.51|1.07||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV1|PR5I minus INFANRIX™ hexa|1.07|-0.51|< 0.001
91651971|NCT01341639|183195969|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.69|1.21||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV2|PR5I minus INFANRIX™ hexa|1.21|-0.69|< 0.001
91651972|NCT01341639|183195969|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.73||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV3|PR5I minus INFANRIX™ hexa|0.73|-0.7|< 0.001
91651973|NCT01341639|183195970|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.58|||<|0.001|TWO_SIDED|95.0|-0.49|1.85||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for HBsAg|PR5I minus INFANRIX™ hexa|1.85|-0.49|< 0.001
91651974|NCT01341639|183195970|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|1.33|||<|0.001|TWO_SIDED|95.0|0.32|2.86||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PT|PR5I minus INFANRIX™ hexa|2.86|0.32|< 0.001
91651975|NCT01341639|183195970|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-2.59|||<|0.001|TWO_SIDED|95.0|-4.39|-1.29||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for FHA|PR5I minus INFANRIX™ hexa|-1.29|-4.39|< 0.001
91709684|NCT01461473|183311850|SUPERIORITY_OR_OTHER|||||||0.3902|||||||GLMM|||Generalized linear mixed model (GLMM) was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3902
91709685|NCT01461473|183311851|SUPERIORITY_OR_OTHER|||||||0.9319|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.9319
91523463|NCT03170375|182922674|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
91606346|NCT03093402|183104944|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||0.285
91606347|NCT03093402|183104946|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||||0.872|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.872
91606348|NCT03093402|183104946|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||||0.895|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.895
91606349|NCT03093402|183104946|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||||0.669|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.669
91606350|NCT03093402|183104946|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||||0.668|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.668
91606351|NCT03093402|183104947|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.82|TWO_SIDED|95.0|-2.3|1.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for High JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.5|-2.3|.820
91606352|NCT03093402|183104947|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.82|TWO_SIDED|95.0|-2.0|1.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Medium JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.8|-2.0|.820
91606353|NCT03093402|183104947|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.82|TWO_SIDED|95.0|-2.6|1.1||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Low JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.1|-2.6|.820
91606354|NCT03093402|183104948|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.244|TWO_SIDED|95.0|-3.0|4.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||4.4|-3.0|.244
91709686|NCT01461473|183311852|SUPERIORITY_OR_OTHER|||||||0.3895|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3895
91606355|NCT03093402|183104948|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.244|TWO_SIDED|95.0|-5.2|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Medium JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||2.0|-5.2|.244
91651976|NCT01341639|183195970|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.03|||<|0.001|TWO_SIDED|95.0|-1.4|1.52||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRN|PR5I minus INFANRIX™ hexa|1.52|-1.4|< 0.001
91651977|NCT01341639|183195972|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.26|||<|0.001|TWO_SIDED|95.0|-2.82|2.25||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Measles|PR5I minus INFANRIX™ hexa|2.25|-2.82|< 0.001
91651978|NCT01341639|183195972|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|3.07|||<|0.001|TWO_SIDED|95.0|-0.12|6.4||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Mumps|PR5I minus INFANRIX™ hexa|6.4|-0.12|< 0.001
91606356|NCT03093402|183104948|SUPERIORITY||Median Difference (Final Values)|-2.6||||0.244|TWO_SIDED|95.0|-6.2|0.9||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||0.9|-6.2|.244
91606357|NCT03093402|183104949|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.408|TWO_SIDED|95.0|-0.27|0.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.40|-0.27|0.408
91606358|NCT03093402|183104949|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.408|TWO_SIDED|95.0|-0.4|0.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.26|-0.40|0.408
91606359|NCT03093402|183104949|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.408|TWO_SIDED|95.0|-0.5|0.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.16|-0.50|0.408
91651979|NCT01341639|183195972|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.39|||<|0.001|TWO_SIDED|95.0|-1.5|2.34||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Rubella|PR5I minus INFANRIX™ hexa|2.34|-1.5|< 0.001
91651980|NCT01341639|183195972|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.02|||<|0.001|TWO_SIDED|95.0|-2.11|2.06||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Varicella|PR5I minus INFANRIX™ hexa|2.06|-2.11|< 0.001
91788006|NCT03512457|183456338|SUPERIORITY|Chi-square||||||0.12||||||P-value of \<0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.|Chi-squared|Chi-Squared is equal to 1.58, with a P-Value of 0.12.||change from baseline to 3 months in performance of skin self-examination Parallel: response rate||||0.12
91788007|NCT03512457|183456339|SUPERIORITY|Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma|||||<|0.05|||||||Chi-squared|||results of skin clinical examination and biopsy of clinically suspicious moles||||<0.05
91788008|NCT03602560|183456353|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91788009|NCT03602560|183456353|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91788010|NCT03602560|183456354|OTHER|Two-sided p-value for each pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 350 U/L; pruritus NRS: \<4 and 4). Breslow-Day test was used to check the homogeneity of treatment effects across stratum.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91523464|NCT02007434|182922675|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.24|STANDARD_ERROR_OF_MEAN|0.59||0.6803|TWO_SIDED|95.0|-0.93|1.41|||ANCOVA||Paradigm 1 - Paradigm 2|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.41|-0.93|0.6803
91606360|NCT03093402|183104950|SUPERIORITY||Mean Difference (Final Values)|-21.48||||0.07|TWO_SIDED|95.0|-37.24|-5.72||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||-5.72|-37.24|0.070
91606361|NCT03093402|183104950|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.07|TWO_SIDED|95.0|-25.33|4.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.54|-25.33|0.070
91606362|NCT03093402|183104950|SUPERIORITY||Mean Difference (Final Values)|-10.81||||0.07|TWO_SIDED|95.0|-25.78|4.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.16|-25.78|0.070
91606363|NCT03093402|183104951|SUPERIORITY||Median Difference (Final Values)|0.3||||0.979|TWO_SIDED|95.0|-3.38|3.99||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.99|-3.38|0.979
91788011|NCT03602560|183456354|OTHER|Two-sided p-value for each pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both randomization stratification variables (ALP level: \< 350 U/L and \>= 350 U/L; pruritus NRS: \< 4 and \>= 4). Breslow-Day test is used to check the homogeneity of treatment effects across stratum.||||||0.0839|||||||Cochran-Mantel-Haenszel|||||||0.0839
91788012|NCT03602560|183456355|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-1.59||||0.0164|TWO_SIDED|95.0|-2.87|-0.3|||ANCOVA|||||-0.3|-2.87|0.0164
91788013|NCT03602560|183456355|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-0.46||||0.4781|TWO_SIDED|95.0|-1.77|0.84|||ANCOVA|||||0.84|-1.77|0.4781
91788014|NCT01379508|183456376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-4.0|||||TWO_SIDED|95.0|-10.5|2.5||||||Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||2.5|-10.5|
91709687|NCT01461473|183311853|SUPERIORITY_OR_OTHER|||||||0.3449|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.3449
91709688|NCT01461473|183311854|SUPERIORITY_OR_OTHER|||||||0.1531|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.1531
91606364|NCT03093402|183104951|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.979|TWO_SIDED|95.0|-3.13|3.93||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.93|-3.13|0.979
91606365|NCT03093402|183104951|SUPERIORITY||Median Difference (Final Values)|0.77||||0.979|TWO_SIDED|95.0|-2.77|4.31||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Physical Function Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||4.31|-2.77|0.979
91651981|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or systemic AEs|PR5I minus INFANRIX™ hexa|0.4|-1.9|
91651982|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or vaccine-related systemic AEs|PR5I minus INFANRIX™ hexa|1.1|-1.8|
91651983|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.1|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 ISR|PR5I minus INFANRIX™ hexa|4.3|-2.1|
91651984|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-2.4|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited ISR|PR5I minus INFANRIX™ hexa|4.3|-2.4|
91791002|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91651985|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-2.4|0.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 systemic AE|PR5I minus INFANRIX™ hexa|0.3|-2.4|
91651986|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-3.2|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related systemic AE|PR5I minus INFANRIX™ hexa|1.3|-3.2|
91709689|NCT00435461|183311865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
91523465|NCT02007434|182922675|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.39|STANDARD_ERROR_OF_MEAN|0.61||0.5206|TWO_SIDED|95.0|-0.82|1.6|||ANCOVA||Paradigm 1 - Paradigm 3|Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.60|-0.82|0.5206
91651987|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.0|-3.3|0.2|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited systemic AE|PR5I minus INFANRIX™ hexa|0.2|-3.3|
91651988|NCT01341639|183195973|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related solicited systemic AE|PR5I minus INFANRIX™ hexa|1.1|-3.7|
91651989|NCT01341639|183195974|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-0.5|10.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site erythema|PR5I minus INFANRIX™ hexa|10.1|-0.5|
91709690|NCT00435461|183311865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
91709691|NCT00435461|183311865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.816|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||||0.2|-0.3|0.816
91709692|NCT00435461|183311866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.9|||ANCOVA|||||-0.9|-1.6|<0.001
91709693|NCT00435461|183311866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||||-0.7|-1.4|<0.001
91791003|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.405||0.979|TWO_SIDED|95.0|-0.808|0.786||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.786|-0.808|0.979
91791004|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91606366|NCT03093402|183104952|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.788|TWO_SIDED|95.0|-6.14|3.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||3.26|-6.14|0.788
91606367|NCT03093402|183104952|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.788|TWO_SIDED|95.0|-6.07|2.96||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||2.96|-6.07|0.788
91606368|NCT03093402|183104952|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.788|TWO_SIDED|95.0|-4.0|4.94||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||4.94|-4.00|0.788
91606369|NCT03093402|183104953|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.766|TWO_SIDED|95.0|-6.14|3.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.16|-6.14|0.766
91606370|NCT03093402|183104953|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.766|TWO_SIDED|95.0|-3.6|5.11||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||5.11|-3.60|0.766
91606371|NCT03093402|183104953|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.766|TWO_SIDED|95.0|-5.55|3.07||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.07|-5.55|0.766
91606372|NCT03093402|183104954|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.982|TWO_SIDED|95.0|-6.04|5.17||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||5.17|-6.04|0.982
91606373|NCT03093402|183104954|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.982|TWO_SIDED|95.0|-6.22|4.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|Each active JBT-101 cohort is compared to placebo.||4.50|-6.22|0.982
91606374|NCT03093402|183104954|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.982|TWO_SIDED|95.0|-6.32|4.36||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||4.36|-6.32|0.982
91606375|NCT03093402|183104955|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.607|TWO_SIDED|95.0|-4.74|4.91||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||4.91|-4.74|0.607
91606376|NCT03093402|183104955|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.607|TWO_SIDED|95.0|-1.85|7.71||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||7.71|-1.85|0.607
91651990|NCT01341639|183195974|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site pain|PR5I minus INFANRIX™ hexa|6.8|-3.2|
91791005|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.415||0.663|TWO_SIDED|95.0|-0.996|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.634|-0.996|0.663
91709694|NCT00435461|183311866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
91709695|NCT00435461|183311867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||ANCOVA|||||-0.7|-1.5|<0.001
91606377|NCT03093402|183104955|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.607|TWO_SIDED|95.0|-3.22|6.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||6.09|-3.22|0.607
91606378|NCT03093402|183104956|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.981|TWO_SIDED|95.0|-4.66|4.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.30|-4.66|0.981
91606379|NCT03093402|183104956|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.981|TWO_SIDED|95.0|-3.84|4.86||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.86|-3.84|0.981
91606380|NCT03093402|183104956|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.981|TWO_SIDED|95.0|-4.62|4.08||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.08|-4.62|0.981
91651991|NCT01341639|183195974|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-1.6|9.6|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site swelling|PR5I minus INFANRIX™ hexa|9.6|-1.6|
91651992|NCT01341639|183195975|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.8|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site bruising|PR5I minus INFANRIX™ hexa|2.1|-1.8|
91651993|NCT01341639|183195975|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.6|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haematoma|PR5I minus INFANRIX™ hexa|2.1|-0.6|
91651994|NCT01341639|183195975|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-2.3|0.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haemorrhage|PR5I minus INFANRIX™ hexa|0.8|-2.3|
91709696|NCT00435461|183311867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
91651995|NCT01341639|183195975|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.8|0.5|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site induration|PR5I minus INFANRIX™ hexa|0.5|-7.8|
91651996|NCT01341639|183195975|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-1.7|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site nodule|PR5I minus INFANRIX™ hexa|1.3|-1.7|
91709697|NCT00435461|183311867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.136|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.136
91709698|NCT00435461|183311868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|||||-0.8|-1.6|<0.001
91709699|NCT00435461|183311868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.3|-0.6|||ANCOVA|||||-0.6|-1.3|<0.001
91709700|NCT00435461|183311868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
91709701|NCT00435461|183311869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001
91709702|NCT00435461|183311869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
91709703|NCT00435461|183311869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
91709704|NCT00435461|183311870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.007|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.007
91709705|NCT00435461|183311870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
91709706|NCT00435461|183311870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.106
91709707|NCT00435461|183311871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||||-0.2|-0.7|0.003
91709708|NCT00435461|183311871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
91709709|NCT00435461|183311871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
91709710|NCT00435461|183311872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.7|-1.0|||ANCOVA|||Pre-dose iTNSS||-1|-1.7|<0.001
91709711|NCT00435461|183311872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Pre-dose iTNSS||-0.7|-1.4|<0.001
91709712|NCT00435461|183311872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.193|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Pre-dose iTNSS||0.1|-0.6|0.193
91606381|NCT03093402|183104957|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.653|TWO_SIDED|95.0|-6.0|2.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||2.29|-6.00|0.653
91606382|NCT03093402|183104957|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.653|TWO_SIDED|95.0|-3.1|4.88||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||4.88|-3.10|0.653
91606383|NCT03093402|183104957|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.653|TWO_SIDED|95.0|-4.31|3.67||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||3.67|-4.31|0.653
91709713|NCT00435461|183311872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Pre-dose iTOSS||-0.2|-0.8|<0.001
91709714|NCT00435461|183311872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.058|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.6|0.058
91709715|NCT00435461|183311872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.16|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.5|0.16
91709716|NCT00435461|183311873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.7|11.9|||ANCOVA|||Morning assessment||11.9|5.7|<0.001
91709717|NCT00435461|183311873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||ANCOVA|||Morning assessment||11.5|5.3|<0.001
91709718|NCT00435461|183311873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.59||0.779|TWO_SIDED|95.0|-3.6|2.7|||ANCOVA|||Morning assessment||2.7|-3.6|0.779
91709719|NCT00435461|183311873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.1|9.6|||ANCOVA|||Evening assessment||9.6|3.1|<0.001
91709720|NCT00435461|183311873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.8|10.3|||ANCOVA|||Evening assessment||10.3|3.8|<0.001
91709721|NCT00435461|183311873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.65||0.662|TWO_SIDED|95.0|-2.5|4.0|||ANCOVA|||Evening assessment||4|-2.5|0.662
91709722|NCT00435461|183311874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
91709723|NCT00435461|183311874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.203|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.203
91709724|NCT00435461|183311874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||ANCOVA|||||-0.4|-0.8|<0.001
91709725|NCT01515696|183311888|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.61
91709726|NCT01515696|183311889|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.5||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91709727|NCT01515696|183311890|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91709728|NCT01188668|183311896|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.97|||||TWO_SIDED|90.0|101.39|110.76|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||110.76|101.39|
91709729|NCT01188668|183311897|SUPERIORITY_OR_OTHER||ratio of adjusted means|101.05|||||TWO_SIDED|90.0|92.94|109.87|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||109.87|92.94|
91709730|NCT01188668|183311902|SUPERIORITY_OR_OTHER||ratio of adjusted means|102.93|||||TWO_SIDED|90.0|94.21|112.46|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||112.46|94.21|
91606384|NCT03093402|183104958|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.245|TWO_SIDED|95.0|-2.56|0.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.29|-2.56|0.245
91606385|NCT03093402|183104958|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.245|TWO_SIDED|95.0|-1.93|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.80|-1.93|0.245
91606386|NCT03093402|183104958|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.245|TWO_SIDED|95.0|-2.64|0.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.09|-2.64|0.245
91606387|NCT03093402|183104959|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.608|TWO_SIDED|95.0|-4.45|3.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||3.54|-4.45|0.608
91606388|NCT03093402|183104959|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.27|5.47||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.47|-2.27|0.608
91606389|NCT03093402|183104959|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.25|5.45||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.45|-2.25|0.608
91606390|NCT00331760|183104999|SUPERIORITY|||||||0.12|||||||Chi-squared|||A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.||||0.12
91606391|NCT00331760|183104999|SUPERIORITY|||||||0.043|||||||Chi-squared|||A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.||||0.043
91651997|NCT01341639|183195975|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1||||||95.0|-0.6|3.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site warmth|PR5I minus INFANRIX™ hexa|3|-0.6|
91651998|NCT01341639|183195976|OTHER|Miettinen \& Nurminen method.|Risk Difference (RD)|-2.5|||||TWO_SIDED|95.0|-6.3|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Crying|PR5I minus INFANRIX™ hexa|1.4|-6.3|
91651999|NCT01341639|183195976|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-8.4|2.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Decreased appetite|PR5I minus INFANRIX™ hexa|2.3|-8.4|
91652000|NCT01341639|183195976|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|2.1|||||TWO_SIDED|95.0|-1.7|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Irritability|PR5I minus INFANRIX™ hexa|6|-1.7|
91652001|NCT01341639|183195976|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-6.7|3.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Pyrexia|PR5I minus INFANRIX™ hexa|3.4|-6.7|
91606392|NCT00619229|183105013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.122|TWO_SIDED|95.0|-0.674|2.55||The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.|ANCOVA||For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors 'treatment' and 'centre' and Baseline value as a covariate was used.|"The primary goal of the study was to test the following null hypothesis:~H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil \> μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts."||2.55|-0.674|0.1220
91606393|NCT03417440|183105024|SUPERIORITY||Estimated mean change|-898.0||||0.37|TWO_SIDED|95.0|-2884.82|1088.82||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||1088.82|-2884.82|.37
91606394|NCT03417440|183105024|SUPERIORITY||Estimated mean change|-2602.1||||0.02|TWO_SIDED|95.0|-4687.44|-516.69||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||-516.69|-4687.44|.02
91606395|NCT03417440|183105024|SUPERIORITY||Estimated mean change|-1244.9||||0.23|TWO_SIDED|95.0|-3287.6|797.85|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||797.85|-3287.60|.23
91652002|NCT01341639|183195976|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-7.8|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Somnolence|PR5I minus INFANRIX™ hexa|1.4|-7.8|
91652003|NCT01341639|183195976|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-4.4|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Vomiting|PR5I minus INFANRIX™ hexa|6|-4.4|
91791006|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91606396|NCT03417440|183105024|SUPERIORITY||Estimated mean change|1468.5||||0.31|TWO_SIDED|95.0|-1368.93|4306.02|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4306.02|-1368.93|0.31
91606397|NCT03417440|183105024|SUPERIORITY||Estimated mean change|388.1||||0.78|TWO_SIDED|95.0|-2397.51|3173.62|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3173.62|-2397.51|0.78
91606398|NCT03417440|183105024|SUPERIORITY||Estimated mean change|1991.2||||0.17|TWO_SIDED|95.0|-865.52|4847.86|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4847.86|-865.52|0.17
91652004|NCT01590433|183195977|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91652005|NCT02040428|183195987|SUPERIORITY_OR_OTHER|||||||0.0001|ONE_SIDED||||||Adaptive group sequential design|Whitehead method for triangular test||Superiority||||0.0001
91652006|NCT02040428|183195988|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||Chi-squared|||||||0.0046
91652007|NCT02058628|183195991|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Data is represented as per CTR.|Wilcoxon (Mann-Whitney)|DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.||||||0.0004
91652008|NCT03551730|183196016|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91652009|NCT03551730|183196016|SUPERIORITY||Least Squares Means (Difference)|-0.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91652010|NCT03551730|183196016|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91652011|NCT03551730|183196017|SUPERIORITY||Least Squares Means (Difference)|53922.58||||0.1529|TWO_SIDED||||||ANCOVA|||||||0.1529
91652012|NCT03551730|183196017|SUPERIORITY||Least Squares Means (Difference)|124993.1|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91652013|NCT03551730|183196017|SUPERIORITY||Least Squares Means (Difference)|96385.09||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
91652014|NCT02363010|183196034|SUPERIORITY|||||||0.68||||||A prior threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 12 month weight losses.||||.68
91652015|NCT02363010|183196034|SUPERIORITY|||||||0.11||||||A prior threshold for significance was p\<.05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 18 month weight losses.||||.11
91791007|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.636||0.961|TWO_SIDED|95.0|-1.22|1.282||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.282|-1.220|0.961
91791008|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91791009|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.617||0.833|TWO_SIDED|95.0|-1.083|1.344||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.344|-1.083|0.833
91791010|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|5.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91606399|NCT03417440|183105024|SUPERIORITY||Estimated mean change|-590.7||||0.77|TWO_SIDED|95.0|-4591.17|3409.75|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3409.75|-4591.17|0.77
91606400|NCT03417440|183105025|SUPERIORITY||Mean Difference (Net)|-23.0|STANDARD_DEVIATION|118.7||0.17|ONE_SIDED|90.0||8.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||8.3||0.17
91606401|NCT03417440|183105025|SUPERIORITY||Mean Difference (Net)|37.7|STANDARD_DEVIATION|117.8||0.94|ONE_SIDED|90.0||68.8||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||68.8||0.94
91606402|NCT03417440|183105025|SUPERIORITY||Mean Difference (Net)|52.0|STANDARD_DEVIATION|116.4||0.99|ONE_SIDED|90.0||82.7||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||82.7||0.99
91606403|NCT03417440|183105026|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_DEVIATION|51.0||0.47|ONE_SIDED|90.0|-12.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-12.5|0.47
91606404|NCT03417440|183105026|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|51.0||0.315|ONE_SIDED|90.0|-8.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-8.3|0.315
91606405|NCT03417440|183105026|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_DEVIATION|51.0||0.355|ONE_SIDED|90.0|-9.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-9.4|0.355
91606406|NCT03417440|183105027|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.0||0.86|ONE_SIDED|90.0|-1.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.3|0.86
91652016|NCT02363010|183196035|SUPERIORITY|||||||0.41||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).||||.41
91652017|NCT02363010|183196035|SUPERIORITY|||||||0.46||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.46
91652018|NCT02363010|183196035|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p\< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.82
91652019|NCT02363010|183196035|SUPERIORITY|||||||0.42||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.42
91652020|NCT02363010|183196035|SUPERIORITY|||||||0.28||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.28
91652021|NCT02363010|183196035|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.82
91606407|NCT03417440|183105027|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.0||0.38|ONE_SIDED|90.0|-0.6|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.6|0.38
91606408|NCT03417440|183105027|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.0||0.66|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.66
91652022|NCT02363010|183196036|SUPERIORITY|||||||0.06||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.||||.06
91652023|NCT02363010|183196036|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.||||.30
91652024|NCT02363010|183196037|SUPERIORITY|||||||0.59||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 12 month waist circumference.||||.59
91606409|NCT03417440|183105028|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|19.2||0.69|ONE_SIDED|90.0|-6.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.9|0.69
91606410|NCT03417440|183105028|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|19.2||0.6|ONE_SIDED|90.0|-6.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.0|0.60
91606411|NCT03417440|183105028|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_DEVIATION|19.0||0.11|ONE_SIDED|90.0|-0.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.2|0.11
91652025|NCT02363010|183196037|SUPERIORITY|||||||0.57||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 18 month waist circumference.||||.57
91652026|NCT02363010|183196038|SUPERIORITY|||||||0.978||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.978
91709731|NCT01188668|183311903|SUPERIORITY_OR_OTHER||ratio of adjusted means|106.27|||||TWO_SIDED|90.0|100.97|111.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||111.85|100.97|
91709732|NCT00351936|183311910|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
91709733|NCT00351936|183311911|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
91709734|NCT00351936|183311912|SUPERIORITY_OR_OTHER|||||||0.747||95.0|||||ANCOVA|||||||0.747
91606412|NCT03417440|183105029|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.0||0.94|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.94
91652027|NCT02363010|183196038|SUPERIORITY|||||||0.998||||||A priori threshold for statistical significance was p \<.05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.998
91652028|NCT02363010|183196038|SUPERIORITY|||||||0.878||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.878
91709735|NCT00351936|183311913|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||ANCOVA|||||||0.208
91709736|NCT00351936|183311914|SUPERIORITY_OR_OTHER|||||||0.665||95.0|||||ANCOVA|||||||0.665
91709737|NCT00351936|183311915|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||ANCOVA|||||||0.999
91709738|NCT00351936|183311916|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
91709739|NCT00583011|183311921|EQUIVALENCE||Median Difference (Final Values)|0.02|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91709740|NCT01129804|183311973|SUPERIORITY|Longitudinal Linear mixed modeling|Slope|0.1|||<|0.04|TWO_SIDED|||||Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p \< .05.|Mixed Models Analysis||||Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.|||<.04
91709741|NCT03658642|183311981|SUPERIORITY||Odds Ratio (OR)|1.22||||0.58|TWO_SIDED|95.0|0.61|2.43|||GEE|Obtained from a GEE model accounting for clustering by site and multiple covariates.||||2.43|0.61|0.58
91709742|NCT03658642|183311982|SUPERIORITY||Odds Ratio (OR)|1.03||||0.95|TWO_SIDED|95.0|0.43|2.47|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.47|0.43|0.95
91709743|NCT03658642|183311984|SUPERIORITY||Odds Ratio (OR)|1.55||||0.01|TWO_SIDED|95.0|1.11|2.16|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.16|1.11|0.01
91709744|NCT03658642|183311985|SUPERIORITY||Odds Ratio (OR)|1.13||||0.48|TWO_SIDED|95.0|0.91|1.57|||GEE|Obtained from a GEE model accounting for clustering by site.||||1.57|0.91|0.48
91709745|NCT03658642|183311986|SUPERIORITY||Odds Ratio (OR)|1.32||||0.27|TWO_SIDED|95.0|0.81|2.14|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.14|0.81|0.27
91709746|NCT04811664|183312089|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|52.6|||||TWO_SIDED|95.0|-14.1|80.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||80.3|-14.1|
91606413|NCT03417440|183105029|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.1||0.73|ONE_SIDED|90.0|-0.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.4|0.73
91606414|NCT03417440|183105029|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.22|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.22
91606415|NCT03417440|183105030|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.46|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.46
91606416|NCT03417440|183105030|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.2||0.96|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.96
91606417|NCT03417440|183105030|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.495|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.495
91606418|NCT03417440|183105031|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.5||0.445|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.445
91606419|NCT03417440|183105031|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.4||0.92|ONE_SIDED|90.0|-2.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-2.5|0.92
91606420|NCT03417440|183105031|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_DEVIATION|4.5||0.23|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.23
91652029|NCT02363010|183196038|SUPERIORITY|||||||0.602||||||A priori threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.602
91652030|NCT02363010|183196039|SUPERIORITY|||||||0.487||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.487
91791011|NCT02880956|183460091|OTHER||LS Mean of Difference|0.23|STANDARD_ERROR_OF_MEAN|0.636||0.714|TWO_SIDED|95.0|-1.017|1.484||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.484|-1.017|0.714
91606421|NCT03417440|183105032|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.1||0.78|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.78
91652031|NCT02363010|183196039|SUPERIORITY|||||||0.262||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.262
91652032|NCT02363010|183196039|SUPERIORITY|||||||0.851||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.851
91791012|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|5.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91606422|NCT03417440|183105032|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.1||0.98|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.98
91606423|NCT03417440|183105032|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.13|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.13
91606424|NCT03417440|183105033|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|4.3||0.285|ONE_SIDED|90.0||0.6||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||0.6||0.285
91606425|NCT03417440|183105033|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|4.3||0.5|ONE_SIDED|90.0||1.1||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||1.1||0.50
91606426|NCT03417440|183105033|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|4.3||0.92|ONE_SIDED|90.0||2.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||2.3||0.92
91606427|NCT03417440|183105034|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|4.2||0.42|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.42
91606428|NCT03417440|183105034|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.2||0.82|ONE_SIDED|90.0|-1.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.9|0.82
91606429|NCT03417440|183105034|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|4.2||0.58|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.58
91606430|NCT03417440|183105035|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.0||0.45|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.45
91652033|NCT02363010|183196039|SUPERIORITY|||||||0.978||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.978
91652034|NCT02363010|183196040|SUPERIORITY|||||||0.796||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.796
91652035|NCT02363010|183196040|SUPERIORITY|||||||0.481||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.481
91652036|NCT02363010|183196040|SUPERIORITY|||||||0.872||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.872
91652037|NCT02363010|183196040|SUPERIORITY|||||||0.802||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.802
91652038|NCT02363010|183196041|SUPERIORITY|||||||0.926||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.926
91652039|NCT02363010|183196041|SUPERIORITY|||||||0.82||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.820
91652040|NCT02363010|183196041|SUPERIORITY|||||||0.127||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.127
91606431|NCT03417440|183105035|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|3.9||0.49|ONE_SIDED|90.0|-1.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.0|0.49
91606432|NCT03417440|183105035|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.9||0.61|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.61
91606433|NCT03417440|183105036|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||.84
91606434|NCT03417440|183105036|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
91606435|NCT03417440|183105036|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||.41
91606436|NCT03417440|183105037|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
91606437|NCT03417440|183105037|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
91606438|NCT03417440|183105037|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
91606439|NCT03417440|183105038|OTHER||Spearman Correlation|-0.10435||||0.3116|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Self-efficacy for Physical Activity change and Daily Steps change across 4 months.||||0.3116
91606440|NCT03417440|183105038|OTHER||Spearman Correlation|0.17742||||0.0838|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Correlation between Self-regulation of Physical Activity change and Daily Steps change across 4 months.||||0.0838
91606441|NCT03417440|183105038|OTHER||Spearman Correlation|-0.09834||||0.351|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Family Social Support for Physical Activity change and Daily Steps change across 4 months.||||0.3510
91606442|NCT03417440|183105038|OTHER||Spearman Correlation|-0.04562||||0.6659|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Outcome Expectation for Physical Activity change and Daily Steps change across 4 months.||||0.6659
91606443|NCT03417440|183105038|OTHER||Spearman Correlation|-0.04831||||0.6402|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Aging Self-perceptions (Attitude Toward Own Aging) change and Daily Steps change across 4 months.||||0.6402
91606444|NCT03417440|183105038|OTHER||Spearman Correlation|0.13128||||0.2048|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychosocial Loss change and Daily Steps change across 4 months.||||0.2048
91606445|NCT03417440|183105038|OTHER||Spearman Correlation|0.10022||||0.3445|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Physical Change change and Daily Steps change across 4 months.||||0.3445
91606446|NCT03417440|183105038|OTHER||Spearman Correlation|-0.00866||||0.934|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychological Growth change and Daily Steps change across 4 months.||||0.9340
91652041|NCT02363010|183196041|SUPERIORITY|||||||0.814||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.814
91652042|NCT04527471|183196063|OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1
91606447|NCT01773473|183105065|NON_INFERIORITY_OR_EQUIVALENCE|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
91606448|NCT00826514|183105072|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|-1.15|0.209||||||Analysis was based on analysis of co-variance (ANCOVA) model with baseline value, age and treatment as covariates.||0.209|-1.150|
91606449|NCT00826514|183105075|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.42|STANDARD_ERROR_OF_MEAN|1.901|||TWO_SIDED|90.0|-4.754|1.905||||||Change at Week 6, CPSI Total Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.905|-4.754|
91606450|NCT00826514|183105075|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.931|||TWO_SIDED|90.0|-2.701|0.591||||||Change at Week 6, CPSI PD Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.591|-2.701|
91606451|NCT00826514|183105075|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|90.0|-0.789|1.541||||||Change at Week 6, CPSI US Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.541|-0.789|
91606452|NCT00826514|183105075|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.697|||TWO_SIDED|90.0|-1.785|0.631||||||Change at Week 6, CPSI QoL Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.631|-1.785|
91606453|NCT00826514|183105076|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|90.0|-0.99|1.348||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.348|-0.990|
91606454|NCT00826514|183105077|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|90.0|-1.829|1.452||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.452|-1.829|
91606455|NCT00826514|183105078|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-33.56|STANDARD_ERROR_OF_MEAN|17.026|||TWO_SIDED|90.0|-64.144|-2.968||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||-2.968|-64.144|
91606456|NCT00826514|183105079|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-1.364|0.415||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.415|-1.364|
91606457|NCT00826514|183105080|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-3.146|0.401||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.401|-3.146|
91606458|NCT00826514|183105081|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.417|0.334||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.334|-0.417|
91606459|NCT00826514|183105082|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.765|||TWO_SIDED|90.0|-1.791|1.822||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.822|-1.791|
91606460|NCT00826514|183105083|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.833|||||TWO_SIDED|90.0|0.763|4.407||||||Week 6: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||4.407|0.763|
91606461|NCT00826514|183105083|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.388|2.575||||||Week 16: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||2.575|0.388|
91606462|NCT02249052|183105125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|STANDARD_DEVIATION|25.0311|<|0.0001|TWO_SIDED|95.0|-95.394|-71.265|||t-test, 2 sided|||||-71.265|-95.394|<0.0001
91606463|NCT02249052|183105126|SUPERIORITY_OR_OTHER||Binomial proportion|0.8947|||<|0.0001|TWO_SIDED|95.0|0.6686|0.987|||Sign test|||||.9870|.6686|<.0001
91606464|NCT00144170|183105132|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5||||0.0001|TWO_SIDED|95.0|12.9|24.0|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||24.0|12.9|0.0001
91606465|NCT00144170|183105133|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91606466|NCT00144170|183105134|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.9||||0.0001|TWO_SIDED|95.0|18.6|31.1|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||31.1|18.6|0.0001
91606467|NCT00144170|183105135|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.8||||0.0001|TWO_SIDED|95.0|22.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|22.5|0.0001
91606468|NCT00144170|183105136|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.4||||0.0001|TWO_SIDED|95.0|23.2|35.7|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||35.7|23.2|0.0001
91606469|NCT00144170|183105137|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.6||||0.0001|TWO_SIDED|95.0|20.5|32.6|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||32.6|20.5|0.0001
91606470|NCT00144170|183105138|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.1||||0.0001|TWO_SIDED|95.0|16.2|27.9|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||27.9|16.2|0.0001
91523466|NCT02007434|182922675|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.606|TWO_SIDED|395.0|-0.86|1.46|||ANCOVA||Paradigm 1 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.46|-0.86|0.6060
91606471|NCT00144170|183105139|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.0||||0.0001|TWO_SIDED|95.0|13.3|24.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.7|13.3|0.0001
91606472|NCT00144170|183105140|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7||||0.0001|TWO_SIDED|95.0|13.0|24.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.4|13.0|0.0001
91606473|NCT00144170|183105141|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.2||||0.0001|TWO_SIDED|95.0|11.7|22.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.7|11.7|0.0001
91606474|NCT00144170|183105142|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.1||||0.0001|TWO_SIDED|95.0|11.7|22.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.4|11.7|0.0001
91606475|NCT00144170|183105143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3||||0.0001|TWO_SIDED|95.0|12.0|22.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.5|12.0|0.0001
91606476|NCT00144170|183105144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.4||||0.0001|TWO_SIDED|95.0|11.2|21.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.5|11.2|0.0001
91606477|NCT00144170|183105145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.2||||0.0001|TWO_SIDED|95.0|11.1|21.3||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.3|11.1|0.0001
91606478|NCT00144170|183105146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.6||||0.0001|TWO_SIDED|95.0|10.6|20.6||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||20.6|10.6|0.0001
91606479|NCT00144170|183105147|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91606480|NCT00144170|183105148|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91606481|NCT00144170|183105149|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91606482|NCT00144170|183105223|SUPERIORITY_OR_OTHER|||||||0.1026||95.0|||||Log Rank|||||||0.1026
91606483|NCT00655928|183105230|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91606484|NCT04551014|183105231|NON_INFERIORITY|For polypectomy without submucosal injection of EverLiftTM to be considered non-inferior, we calculated that 115 polyps were needed in each group to achieve an alpha value of 0.05, power of 90%, and non-inferiority margin of -10%.||||||0.424|||||||t-test, 2 sided|||||||0.424
91606485|NCT04551014|183105232|SUPERIORITY||||||<|0.0001||||||P-value of \<0.05 was considered statistically significant.|t-test, 2 sided|||||||<0.0001
91606486|NCT04551014|183105233|SUPERIORITY|||||||0.697||||||P-value of \<0.05 was considered statistically significant.|Chi-squared|||||||0.697
91606487|NCT04108429|183105235|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.830
91606488|NCT04108429|183105236|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.759
91606489|NCT04108429|183105237|SUPERIORITY|||||||0.275|||||||Simulation Modeling Analysis (SMA) for T|||Counseling center utilization data were examined using Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in utilization between the pre-implementation and implementation phases. SMA evaluates the statistical significance of between-phase changes in data streams and also accounts for the presence of autocorrelation (the non-independence of data points in time-series data streams).||||.275
91606490|NCT04108429|183105239|SUPERIORITY|generalized linear mixed model||||||0.002|||||||Mixed Models Analysis|||||||.002
91606491|NCT04108429|183105240|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||generalized linear mixed model||||.489
91606492|NCT04108429|183105241|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||generalized linear mixed model||||.001
91606493|NCT00275561|183105244|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Fisher Exact|||||||0.74
91606494|NCT00275561|183105245|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Fisher Exact|||||||0.49
91606495|NCT00275561|183105246|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91652043|NCT02884206|183196107|NON_INFERIORITY|To demonstrate non-inferiority that LCZ696 does not lead to a relevant decrease in cognition compared to valsartan at year 3, the lower bound of 95% CI does not include the pre-specified non-inferiority (NI) boundary (Cohen's D) of -0.3. An effect size of 0.3 in Cohen's D is generally considered as small.|LSM|-0.018||||0.7363|TWO_SIDED|95.0|-0.123|0.087|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0277, 95% CI: -0.1101 to 0.0778|0.0870|-0.1230|0.7363
91791013|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.663||0.518|TWO_SIDED|95.0|-1.733|0.876||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.876|-1.733|0.518
91652044|NCT02884206|183196108|NON_INFERIORITY|To show that the point estimate of SUVr difference in mean change over 3 years is in favor of LCZ696 and the non-inferiority is demonstrated, with the upper bound of the 95% CI excluding the NI boundary of 0.01.|Least Squares Mean|-0.0292||||0.0579|TWO_SIDED|95.0|-0.0593|0.001|||ANCOVA|||Multiple Imputation ANCOVA in Global cortical composite||0.0010|-0.0593|0.0579
91652045|NCT02884206|183196109|SUPERIORITY||Least Squares Mean|0.0007||||0.9916|TWO_SIDED|95.0|-0.1339|0.1353|||ANCOVA|||Repeated measure ANCOVA for memory domain|Cohen's D: 0.0009; 95% CI: -0.0912 to 0.0922|0.1353|-0.1339|0.9916
91652046|NCT02884206|183196109|SUPERIORITY||Least Squares Mean|0.0327||||0.6348|TWO_SIDED|95.0|-0.1024|0.1677|||ANCOVA|||Repeated measure ANCOVA for executive function domain|Cohen's D: 0.0391, 95% CI: -0.0727 to 0.1192|0.1677|-0.1024|0.6348
91652047|NCT02884206|183196109|SUPERIORITY||Least Squares Mean|-0.1042||||0.2403|TWO_SIDED|95.0|-0.2783|0.07|||ANCOVA|||Repeated measure ANCOVA for attention domain|Cohen's D: -0.0967, 95% CI: -0.1542 to 0.0387|0.0700|-0.2783|0.2403
91652048|NCT02884206|183196110|SUPERIORITY||Least Squares Mean|-0.1105||||0.7081|TWO_SIDED|95.0|-0.6906|0.4696|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0308, 95% CI: -0.1208 to 0.0820|0.4696|-0.6906|0.7081
91652049|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.74|||||ONE_SIDED||||||||GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"||||
91652050|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.76|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652051|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.15|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652052|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652053|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.52|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652054|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652055|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652056|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652057|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI GMT ratio|1.23|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652058|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.12|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91791014|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|5.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91709747|NCT04811664|183312092|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|71.0|||||TWO_SIDED|95.0|-9.5|92.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||92.3|-9.5|
91606496|NCT01392183|183105255|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.84|2.22|||||Adjusted Hazard Ratio comparing Median PFS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||2.22|0.84|
91606497|NCT01392183|183105256|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.7|1.93|||||Adjusted HR comparing Median OS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||1.93|0.7|
91606498|NCT00963807|183105261|SUPERIORITY_OR_OTHER|||||||0.336|||||||t-test, 2 sided|||||||0.336
91606499|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.99||||0.8918|TWO_SIDED|95.0|-15.5|13.52|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||13.52|-15.50|0.8918
91606500|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.89||||0.5183|TWO_SIDED|95.0|-19.91|10.14|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.14|-19.91|0.5183
91606501|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.89||||0.5718|TWO_SIDED|95.0|-17.59|9.8|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||9.80|-17.59|0.5718
91606502|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.37||||0.6591|TWO_SIDED|95.0|-11.82|18.56|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||18.56|-11.82|0.6591
91606503|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.02||||0.6921|TWO_SIDED|95.0|-18.17|12.13|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.13|-18.17|0.6921
91606504|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3513|TWO_SIDED|95.0|-19.98|7.2|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||7.20|-19.98|0.3513
91606505|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.2346|TWO_SIDED|95.0|-5.96|23.88|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||23.88|-5.96|0.2346
91606506|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.24||||0.4138|TWO_SIDED|95.0|-8.92|21.39|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.39|-8.92|0.4138
91606507|NCT01587950|183105264|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.72||||0.6931|TWO_SIDED|95.0|-16.44|10.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.99|-16.44|0.6931
91709748|NCT04811664|183312093|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|41.2|||||TWO_SIDED|95.0|-37.7|74.9|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||74.9|-37.7|
91788015|NCT01379508|183456376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.1|||||TWO_SIDED|95.0|-9.4|3.1||||||Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||3.1|-9.4|
91606508|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3867|TWO_SIDED|95.0|-21.04|8.26|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.26|-21.04|0.3867
91606509|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.22||||0.1448|TWO_SIDED|95.0|-26.41|3.96|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||3.96|-26.41|0.1448
91606510|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.83||||0.4874|TWO_SIDED|95.0|-18.66|8.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.99|-18.66|0.4874
91606511|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.87||||0.2038|TWO_SIDED|95.0|-25.23|5.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||5.49|-25.23|0.2038
91606512|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.12||||0.1518|TWO_SIDED|95.0|-26.43|4.19|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||4.19|-26.43|0.1518
91606513|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.25||||0.8567|TWO_SIDED|95.0|-14.98|12.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.49|-14.98|0.8567
91606514|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.01||||0.1493|TWO_SIDED|95.0|-4.06|26.08|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||26.08|-4.06|0.1493
91606515|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.45||||0.4798|TWO_SIDED|95.0|-9.86|20.76|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||20.76|-9.86|0.4798
91606516|NCT01587950|183105265|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.56||||0.4255|TWO_SIDED|95.0|-19.42|8.29|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.29|-19.42|0.4255
91652059|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.46|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652060|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.61|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91791015|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.654||0.633|TWO_SIDED|95.0|-1.598|0.973||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.973|-1.598|0.633
91709749|NCT02717442|183312107|SUPERIORITY||Risk Ratio (RR)|0.658|||=|0.029|TWO_SIDED|95.0|0.453|0.957||Study week was based on each 4-week interval and was modeled as a categorical variable, and an offset for the log of the number of diary entries recorded for each 4-week interval post-baseline was included for each subject.|Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.957|0.453|=0.029
91709750|NCT02717442|183312108|SUPERIORITY||Risk Ratio (RR)|0.59|||=|0.014|TWO_SIDED|95.0|0.388|0.896|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.896|0.388|=0.014
91606517|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.96||||0.7769||95.0|-15.71|11.8||ANCOVA with factors for treatment group, application site, period and random effect for subject.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.80|-15.71|0.7769
91606518|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.32||||0.3811|TWO_SIDED|95.0|-20.64|8.0|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.00|-20.64|0.3811
91606519|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.36||||0.5044||95.0|-17.35|8.63|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.63|-17.35|0.5044
91652061|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.39|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652062|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.1|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652063|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.65|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652064|NCT01492582|183196118|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|-0.44|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
91652065|NCT01492582|183196119|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||<0.001
91652066|NCT01492582|183196119|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.03
91788016|NCT01379508|183456376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.8|||||TWO_SIDED|95.0|-7.9|0.4||||||Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients||0.4|-7.9|
91606520|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.68||||0.4374|TWO_SIDED|95.0|-20.2|8.84|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.84|-20.20|0.4374
91709751|NCT00076258|183312118|SUPERIORITY_OR_OTHER_LEGACY||Remission rate|29.5|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|Both unadjusted and adjusted rates (for significant covariates) were reported||||||<0.05
91791016|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|4.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91606521|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Slope|-4.02||||0.5796|TWO_SIDED|95.0|-18.46|10.41|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.41|-18.46|0.5796
91606522|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66||||0.7994|TWO_SIDED|95.0|-11.32|14.64|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05||14.64|-11.32|0.7994
91606523|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.75||||0.2784|TWO_SIDED|95.0|-6.42|21.93|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.93|-6.42|0.2784
91606524|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.68||||0.3581|TWO_SIDED|95.0|-7.75|21.12|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.12|-7.75|0.3581
91606525|NCT01587950|183105266|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.07||||0.8703|TWO_SIDED|95.0|-14.11|11.97|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.97|-14.11|0.8703
91606526|NCT00371267|183105294|SUPERIORITY_OR_OTHER||||||<|0.27|TWO_SIDED||||||Mixed Models Analysis|||||||<0.27
91606527|NCT00371267|183105295|SUPERIORITY_OR_OTHER||||||<|0.35|TWO_SIDED||||||Mixed Models Analysis|||||||<0.35
91606528|NCT00371267|183105296|SUPERIORITY_OR_OTHER||||||<|0.74|TWO_SIDED||||||Mixed Models Analysis|||||||<0.74
91652067|NCT01492582|183196119|SUPERIORITY|||||||0.48|||||||Chi-squared, Corrected|||Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.48
91652068|NCT01492582|183196119|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||<0.001
91652069|NCT01492582|183196119|SUPERIORITY|||||||0.07|||||||Chi-squared, Corrected|||Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.07
91652070|NCT01492582|183196119|SUPERIORITY|||||||0.28|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.28
91788017|NCT01379508|183456376|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-2.3|||||TWO_SIDED|95.0|-8.3|3.8||||||Imputing within +28d DNA for wk52: d/c for non response \<28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure)||3.8|-8.3|
91606529|NCT00371267|183105297|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
91606530|NCT00371267|183105298|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
91606531|NCT01575912|183105327|OTHER|||||||0.121||||||using Mann Whitney test|Wilcoxon (Mann-Whitney)|||||||0.121
91606532|NCT03263091|183105363|OTHER||Odds Ratio (OR)|1.582||||0.217|TWO_SIDED|95.0|0.761|3.29|||Cochran-Mantel-Haenszel|||The odds ratio along with its 95% confidence interval (CI) were calculated based on the Cochran-Mantel-Haenszel (CMH) chi-square test adjusting for the stratification factors (EPO level, International Prognostic Scoring System - Revised \[IPSS-R\] risk category and RBC transfusion burden).||3.290|0.761|0.217
91606533|NCT00265941|183105383|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.88|1.32|||Log Rank||Reference arm = RT + cisplatin|A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).||1.32|0.88|0.76
91606534|NCT00265941|183105384|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.32|TWO_SIDED|95.0|0.74|1.21|||Log Rank|One-sided log-rank significance level of 0.025|Reference level = RT + cisplatin|Arms were compared using a one-sided log-rank test at the 0.025 significance level.||1.21|0.74|0.32
91606535|NCT00265941|183105385|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.97|TWO_SIDED|95.0|0.99|1.7|||Log Rank|One-sided significance level of 0.025|Reference level = RT + cisplatin|||1.70|0.99|0.97
91606536|NCT00265941|183105390|SUPERIORITY|||||||0.74|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||3 months||||0.74
91606537|NCT00265941|183105390|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||12 months||||0.99
91652071|NCT01492582|183196119|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.45
91652072|NCT00096265|183196149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.93|TWO_SIDED|95.0|0.89|2.31||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.31|0.89|0.93
91788018|NCT00833664|183456380|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|88.1|109.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.5|88.1|
91788019|NCT00833664|183456381|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|107.6||||||90.0|104.7|110.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.6|104.7|
91606538|NCT00265941|183105391|SUPERIORITY|||||||0.13|||||||Chi-squared|2-sided significance level of 0.05||Diet 3-month||||0.13
91606539|NCT00265941|183105391|SUPERIORITY|||||||0.87|||||||Chi-squared|2-sided significance level 0.05||Diet 12-month||||0.87
91606540|NCT00265941|183105391|SUPERIORITY|||||||0.39|||||||Chi-squared|2-sided significance level of 0.05||Eating 3-month||||0.39
91606541|NCT00265941|183105391|SUPERIORITY|||||||0.16|||||||Chi-squared|2-sided significance level of 0.05||Eating 12-month||||0.16
91606542|NCT00265941|183105391|SUPERIORITY|||||||0.81|||||||Chi-squared|2-sided significance level of 0.05||Speech 3-month||||0.81
91606543|NCT00265941|183105391|SUPERIORITY|||||||0.67|||||||Chi-squared|2-sided significance level of 0.05||Speech 12-month||||0.67
91606544|NCT00265941|183105392|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|2-sided significance level of 0.05||||||0.016
91606545|NCT00265941|183105393|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6|TWO_SIDED|95.0|0.79|1.51|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Progression-free survival is compared between favorable risk and unfavorable risk groups.||1.51|0.79|0.60
91606546|NCT00265941|183105393|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.37|TWO_SIDED|95.0|0.81|1.76|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Overall survival is compared between favorable risk and unfavorable risk groups.||1.76|0.81|0.37
91606547|NCT00265941|183105393|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.46|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Local-regional failure||1.46|0.60|0.76
91652073|NCT00096265|183196149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.95|TWO_SIDED|95.0|0.92|2.36||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.36|0.92|0.95
91652074|NCT00096265|183196150|SUPERIORITY|||||||0.3|||||||Gray's test|||||||0.30
91606548|NCT00265941|183105394|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.12|0.75|||Log Rank|2-sided significance level = 0.05|Reference level = low|Progression-free survival is compared between low and high SUVmax groups.||0.75|0.12|0.01
91606549|NCT00265941|183105394|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.1|TWO_SIDED|95.0|0.12|1.2|||Log Rank|2-sided significance level = 0.05|Reference level = low|Overall survival (OS) is compared between low and high SUVmax groups.||1.20|0.12|0.10
91606550|NCT00265941|183105394|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.04|TWO_SIDED|95.0|0.1|0.97|||Log Rank|2-sided significance level = 0.05|Reference level = low|Loco-regional control (LRC) is compared between low and high SUVmax groups.||0.97|0.10|0.04
91606551|NCT00318292|183105403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.003||95.0|-3.2|-0.7|||t-test, 2 sided|||||-0.7|-3.2|.003
91606552|NCT02432807|183105423|SUPERIORITY|||||||0.2219|||||||Chi-squared|||||||0.2219
91606553|NCT02432807|183105424|SUPERIORITY|||||||0.1817|||||||Chi-squared|||||||0.1817
91606554|NCT02966314|183105461|SUPERIORITY||Odds Ratio (OR)|18.7||||0.003|TWO_SIDED|95.0|2.77|126.47|||Regression, Logistic|Accounting for repeated measures||||126.47|2.77|0.003
91606555|NCT02966314|183105463|SUPERIORITY||Mean Difference (Final Values)|9.43||||0.03|TWO_SIDED|95.0|1.24|17.63|||Regression, Linear|||||17.63|1.24|0.03
91606556|NCT02966314|183105465|SUPERIORITY||Odds Ratio (OR)|32.8||||0.03|TWO_SIDED|95.0|1.49|720.54|||Regression, Logistic|Accounting for repeated measures||||720.54|1.49|0.03
91606557|NCT02966314|183105467|SUPERIORITY||Risk Ratio (RR)|6.9||||0.005|TWO_SIDED|95.0|1.9|25.3|||Regression, Linear|Accounting for multiple measures, using poisson distribution with natural log link||||25.3|1.9|0.005
91606558|NCT00310310|183105482|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
91606559|NCT00310310|183105483|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 1 sided|||||||0.023
91606560|NCT00310310|183105484|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 1 sided|||||||0.8
91606561|NCT00310310|183105486|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 1 sided|||||||0.96
91606562|NCT00310310|183105487|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 1 sided|||||||0.59
91606563|NCT00310310|183105488|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 1 sided|||||||0.00
91606564|NCT00310310|183105489|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
91652075|NCT00096265|183196150|SUPERIORITY|||||||0.48|||||||Gray's test|||||||0.48
91788020|NCT00833664|183456382|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|92.7|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.0|92.7|
91788021|NCT03952039|183456383|SUPERIORITY||Difference in Proportion|29.6|||<|0.0001|TWO_SIDED|95.0|19.9|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||39.4|19.9|<0.0001
91606565|NCT00310310|183105490|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 1 sided|||||||0.08
91709752|NCT00076258|183312118|SUPERIORITY_OR_OTHER_LEGACY||Remission Rate|28.3|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|||For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p \< 0.06 and the NNT of 7.8 for the PHD versus the LD.||||<0.05
91788022|NCT03952039|183456384|SUPERIORITY|Stratified analysis (based on CRF)|Difference in Proportion|17.1||||0.0033|TWO_SIDED|95.0|4.8|29.4|||Cochran-Mantel-Haenszel|CMH test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||||29.4|4.8|0.0033
91606566|NCT00310310|183105491|SUPERIORITY_OR_OTHER|||||||0.38|||||||t-test, 1 sided|||||||0.38
91606567|NCT02620020|183105613|SUPERIORITY||Least Squares (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3876|TWO_SIDED|95.0|-0.88|0.34||Nominal p-value|Mixed Models Analysis|||||0.34|-0.88|0.3876
91606568|NCT02620020|183105613|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.018|TWO_SIDED|95.0|-1.32|-0.12||Nominal p-value|Mixed Models Analysis|||||-0.12|-1.32|0.0180
91606569|NCT02620020|183105613|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0288|TWO_SIDED|95.0|-1.26|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-1.26|0.0288
91606570|NCT02620020|183105615|SUPERIORITY||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.73||0.0028|TWO_SIDED|95.0|-3.65|-0.77||Nominal p-value|Mixed Models Analysis|||||-0.77|-3.65|0.0028
91606571|NCT02620020|183105615|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.72||0.0068|TWO_SIDED|95.0|-3.36|-0.54||Nominal p-value|Mixed Models Analysis|||||-0.54|-3.36|0.0068
91606572|NCT02620020|183105615|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.72||0.0006|TWO_SIDED|95.0|-3.88|-1.06||Nominal p-value|Mixed Models Analysis|||||-1.06|-3.88|0.0006
91606573|NCT02620020|183105616|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1501|TWO_SIDED|95.0|-0.46|0.07||Nominal p-value|Mixed Models Analysis|||||0.07|-0.46|0.1501
91606574|NCT02620020|183105616|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2603|TWO_SIDED|95.0|-0.41|0.11||Nominal p-value|Mixed Models Analysis|||||0.11|-0.41|0.2603
91606575|NCT02620020|183105616|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0135|TWO_SIDED|95.0|-0.59|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-0.59|0.0135
91606576|NCT05292755|183105617|OTHER|One-way ANOVA was used to compare mean Faith's phylogenetic diversity before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||||0.232|||||||ANOVA|||||||0.232
91606577|NCT05292755|183105618|OTHER|||||||0.224|||||||ANOVA|||ANOVA was used to compare mean Shannon's diversity indices before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||0.224
91606578|NCT05292755|183105619|OTHER|||||||0.227|||||||Repeated measures Mann-U-Whitney|||Repeated measures Mann-U-Whitney tests were used to compare changes in weighted and unweighted UniFrac distances between intervention groups before and after intervention at a two-tailed 95% confidence interval.||||0.227
91606579|NCT00707577|183105633|SUPERIORITY||||||<|0.05|||||||Regression, Linear|random effects regression models for panel data adjusted for clustering within team||||||<0.05
91606580|NCT00190775|183105634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|STANDARD_ERROR_OF_MEAN|1.11|<|0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||<0.001
91606581|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.905
91606582|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.491
91606583|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.600
91606584|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.052
91606585|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.514
91606586|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.515
91606587|NCT00190775|183105635|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.315
91606588|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
91606589|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.122
91709753|NCT01490840|183312140|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 90 in each group would have 80% power to detect a difference in means of 3.8, assuming that the common standard deviation is 9.05, using a two group t-test with a 0.05 2-sided significance level.|Mean Difference (Net)|-1.47||||0.4579|TWO_SIDED|95.0|-5.39|2.44|||ANCOVA|||||2.44|-5.39|0.4579
91709754|NCT02756819|183312161|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
91788023|NCT03952039|183456385|SUPERIORITY||Difference in Proportion|33.5|||<|0.0001|TWO_SIDED|95.0|21.9|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||45.1|21.9|<0.0001
91788024|NCT03952039|183456388|SUPERIORITY||Greenland and Robins method|19.9|||||TWO_SIDED|95.0|10.0|29.7|||Greenland and Robins method|||||29.7|10.0|
91788025|NCT02656680|183456405|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U Test||||0.72
91788026|NCT02656680|183456406|SUPERIORITY|||||||0.31|||||||Chi-squared|||Chi square test comparing proportion retained in each condition.||||0.31
91606590|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.931||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.931
91606591|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
91652076|NCT00096265|183196152|SUPERIORITY|||||||0.39|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.39
91652077|NCT00096265|183196152|SUPERIORITY|||||||0.28|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.28
91652078|NCT00096265|183196153|SUPERIORITY|||||||0.002|||||||Chi-squared|||108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||0.002
91652079|NCT00096265|183196153|SUPERIORITY||||||<|0.001|||||||Chi-squared|||108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||< 0.001
91652080|NCT00096265|183196154|SUPERIORITY|Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||||0.51|||||||Chi-squared|||||||0.51
91652081|NCT00096265|183196154|SUPERIORITY|||||||0.56|||||||Chi-squared|||Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||0.56
91709755|NCT02756819|183312162|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
91606592|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.190
91606593|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
91606594|NCT00190775|183105636|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
91606595|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
91606596|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.705
91606597|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.686
91606598|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.618
91606599|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.903
91606600|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
91606601|NCT00190775|183105637|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.403
91606602|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.941
91606603|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
91606604|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.391
91788027|NCT02656680|183456407|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
91606605|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.685
91606606|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.774
91606607|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
91606608|NCT00190775|183105638|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
91606609|NCT00190775|183105639|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.617
91606610|NCT00190775|183105639|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.789
91606611|NCT00190775|183105639|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.670
91606612|NCT00190775|183105639|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.018
91606613|NCT00190775|183105639|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.405
91606614|NCT00190775|183105640|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.544
91606615|NCT00190775|183105640|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.494
91709756|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
91788028|NCT02656680|183456408|SUPERIORITY|||||||0.218|||||||ANOVA|||We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.||||0.218
91788029|NCT02656680|183456409|SUPERIORITY|||||||0.421|||||||ANOVA|||||||0.421
91788030|NCT04966910|183456422|SUPERIORITY|||||||0.036||||||This p-value applies to the time x condition interaction variable in a repeated-measure ANOVA for client data.|ANOVA|||Repeated measures ANOVA including a time x condition interaction term to test for differences in slopes by condition for client data.||||0.036
91788031|NCT04966910|183456423|SUPERIORITY|||||||0.226||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA.|ANOVA|||||||.226
91788032|NCT04966910|183456424|SUPERIORITY|||||||0.674||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.674
91788033|NCT04966910|183456425|SUPERIORITY|||||||0.317||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.317
91788034|NCT04966910|183456426|SUPERIORITY|||||||0.741||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.741
91788035|NCT04966910|183456427|SUPERIORITY|||||||0.737||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.737
91788036|NCT00830791|183456431|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.74||||0.325|TWO_SIDED|90.0|0.43|1.26|||ANCOVA||The mean square error on a log scale for this comparison was 0.322.|||1.26|0.43|0.325
91788037|NCT00830791|183456432|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.718|TWO_SIDED|90.0|0.76|1.2|||ANCOVA||The mean square error on a log scale was 0.061 for this comparison.|||1.20|0.76|0.718
91788038|NCT00830791|183456433|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.63||||0.014|TWO_SIDED|90.0|1.21|2.2|||ANCOVA||The mean square error on a log scale was 0.104 for this comparison.|||2.20|1.21|0.014
91788039|NCT00830791|183456435|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14||||0.505|TWO_SIDED|90.0|0.81|1.6|||ANCOVA||The mean square error on a log scale for this comparison was 0.133.|||1.60|0.81|0.505
91606616|NCT00190775|183105640|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.547
91606617|NCT00190775|183105640|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.059
91606618|NCT00190775|183105640|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
91652082|NCT00096265|183196155|SUPERIORITY|||||||0.78|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.78
91652083|NCT00096265|183196155|SUPERIORITY|||||||0.8|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.80
91652084|NCT01172600|183196156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.84|TWO_SIDED|95.0|-1.43|1.17|||Regression, Linear|The analysis adjusted for VAS at baseline (before 1st block), number of epidural blocks received, and imbalanced baseline variables.|This is an intention- to-treat analysis. We assigned missing outcomes to 10 patients.|||1.17|-1.43|0.84
91652085|NCT01172600|183196156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.12|TWO_SIDED|95.0|-2.34|0.28|||Regression, Linear||This is a per-protocol analysis, using 68 patients with completed data.|||0.28|-2.34|0.12
91652086|NCT01172600|183196157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.63|TWO_SIDED|98.3|-1.8|1.21|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||1.21|-1.80|0.63
91709757|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
91606619|NCT00190775|183105641|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.334
91606620|NCT00190775|183105641|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.087
91606621|NCT00190775|183105641|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.795
91606622|NCT00190775|183105641|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.955
91606623|NCT00190775|183105641|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
91652087|NCT01172600|183196158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.16|TWO_SIDED|98.3|-3.05|0.82|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||0.82|-3.05|0.16
91652088|NCT02232074|183196169|SUPERIORITY||Odds Ratio (OR)|0.82||||0.77|TWO_SIDED|95.0|0.21|3.14||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||3.14|0.21|0.77
91652089|NCT02232074|183196170|SUPERIORITY||Odds Ratio (OR)|4.0||||0.26|TWO_SIDED|95.0|0.35|45.4||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||45.4|0.35|0.26
91652090|NCT02232074|183196171|SUPERIORITY||Median Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.42||0.53|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.53
91606624|NCT00190775|183105642|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.248
91606625|NCT00190775|183105642|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.163
91606626|NCT00190775|183105642|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.947
91606627|NCT00190775|183105642|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.214
91606628|NCT00190775|183105642|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.543
91652091|NCT02232074|183196172|SUPERIORITY||Median Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|1.62||0.43|TWO_SIDED|||||Adjusting for baseline Distress Thermometer scores.|Regression, Linear|||Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.43
91652092|NCT02232074|183196173|SUPERIORITY||Median Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.18
91709758|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
91709759|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
91709760|NCT02756819|183312165|OTHER||||||<|0.001|||||||Wilcoxon test|P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)||||||<0.001
91709761|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
91606629|NCT00190775|183105643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.05||0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||0.001
91606630|NCT00190775|183105644|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
91606631|NCT00190775|183105644|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.134
91606632|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.056
91606633|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.459||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.459
91606634|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.435
91606635|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.677
91606636|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.376
91606637|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
91606638|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.030
91606639|NCT00190775|183105645|SUPERIORITY_OR_OTHER|||||||0.434||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.434
91606640|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.578
91606641|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.062
91606642|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.567
91606643|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.383
91606644|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.963
91606645|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.075
91606646|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.854
91606647|NCT00190775|183105646|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.671
91606648|NCT00190775|183105647|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.280
91606649|NCT00190775|183105647|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.34
91606650|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.103
91606651|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.182
91606652|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.161
91709762|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
91709763|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
91709764|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
91788040|NCT00830791|183456437|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
91606653|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.472
91606654|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.949
91606655|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.848
91606656|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.050
91606657|NCT00190775|183105648|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.840
91606658|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.785
91606659|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.081
91606660|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.518
91606661|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.883
91606662|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.439
91606663|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.167
91606664|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.381
91606665|NCT00190775|183105649|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.906
91606666|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.420
91606667|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.249
91606668|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.927
91606669|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.205
91606670|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.673
91606671|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.881||95.0||||P-Value for Parent Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.881
91606672|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.808
91606673|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.498
91709765|NCT02756819|183312165|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
91709766|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
91709767|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
91709768|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
91709769|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
91709770|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|Wilcoxon test|||||||<0.001
91709771|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
91709772|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
91709773|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
91709774|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
91709775|NCT02756819|183312166|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
91788041|NCT00830791|183456438|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
91788042|NCT04175509|183456452|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||.378
91788043|NCT04175509|183456453|SUPERIORITY|||||||0.753|||||||t-test, 2 sided|||||||.753
91788044|NCT04175509|183456454|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
91788045|NCT04175509|183456455|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
91606674|NCT00190775|183105650|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.283
91606675|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.784
91606676|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.864
91606677|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.884
91606678|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.072
91606679|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.120
91606680|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.925||95.0||||P-Value Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.925
91606681|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.444
91606682|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.166
91606683|NCT00190775|183105651|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
91606684|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.895
91606685|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.792
91606686|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.318
91606687|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.914
91606688|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.961||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.961
91523467|NCT02007434|182922675|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.7935|TWO_SIDED|95.0|-0.98|1.27|||ANCOVA||Paradigm 2 - Paradigm 3|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.27|-0.98|0.7935
91606689|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
91606690|NCT00190775|183105652|SUPERIORITY_OR_OTHER|||||||0.827||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.827
91606691|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.828
91606692|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.401
91606693|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.300
91606694|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
91606695|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.772
91606696|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
91606697|NCT00190775|183105653|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.636
91606698|NCT00190775|183105654|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-Value for Total ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.583
91606699|NCT00190775|183105654|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||P-Value for Hyperactive-Impulsive Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.997
91606700|NCT00190775|183105654|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-Value for Inattention Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.333
91606701|NCT00190775|183105655|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Oppositional Defiant Disorder Flag|Fisher Exact|||||||.792
91606702|NCT00190775|183105655|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-Value for Conduct Disorder Flag.|Fisher Exact|||||||0.675
91606703|NCT00190775|183105656|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
91606704|NCT00190775|183105656|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.569
91606705|NCT00190775|183105656|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.399
91606706|NCT00190775|183105657|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.365
91606707|NCT00190775|183105657|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.620
91606708|NCT00190775|183105657|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.462
91606709|NCT00190775|183105658|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Total Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.001
91652093|NCT02232074|183196174|SUPERIORITY||Median Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|1.29||0.33|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.33
91652094|NCT02232074|183196175|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.68|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.68
91652095|NCT02232074|183196176|SUPERIORITY||Median Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.26|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.26
91652096|NCT02232074|183196177|SUPERIORITY||Median Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.43||0.62|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.62
91652097|NCT02232074|183196178|SUPERIORITY||Median Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.91||0.69|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.69
91652098|NCT02232074|183196179|SUPERIORITY||Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.58|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.58
91652099|NCT02232074|183196180|SUPERIORITY||Median Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.21||0.09|TWO_SIDED||||||Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.09
91652100|NCT02232074|183196181|SUPERIORITY||Odds Ratio (OR)|0.85||||0.79|TWO_SIDED|95.0|0.28|2.79||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).||2.79|0.28|0.79
91652101|NCT02232074|183196182|SUPERIORITY||Median Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.||||0.71
91606710|NCT00190775|183105658|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyperactivity Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.004
91606711|NCT00190775|183105658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606712|NCT00190775|183105658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606713|NCT00190775|183105658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Hyperactivity Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606714|NCT00190775|183105658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606715|NCT00190775|183105659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 8 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606716|NCT00190775|183105659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606717|NCT00190775|183105660|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P-Value for 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.553
91606718|NCT00190775|183105660|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.797
91606719|NCT00190775|183105661|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-Value for State Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.108
91606720|NCT00190775|183105661|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-Value for Trait Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.026
91652102|NCT02232074|183196183|SUPERIORITY||Median Difference (Final Values)|-1.45|STANDARD_DEVIATION|2.71||0.61|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment||||0.61
91652103|NCT02232074|183196184|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.08||0.46|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.46
91788046|NCT04175509|183456456|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
91788047|NCT04175509|183456457|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
91788048|NCT04175509|183456458|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
91788049|NCT04175509|183456459|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
91788050|NCT02054481|183456466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.4|||<|0.0001|TWO_SIDED|95.0|19.0|53.8|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||53.8|19.0|<0.0001
91788051|NCT02054481|183456467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6||||0.0355|TWO_SIDED|95.0|1.0|28.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 12||28.2|1.0|0.0355
91606721|NCT00190775|183105661|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-Value is for State Anxiety Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.897
91606722|NCT00190775|183105661|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||P-Value is for Trait Anxiety Score at 24 weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.171
91606723|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.892
91606724|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.003
91606725|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.007
91606726|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.533||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.533
91652104|NCT02232074|183196185|SUPERIORITY||Median Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.2||0.89|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.89
91652105|NCT02232074|183196186|SUPERIORITY||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|1.66||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
91606727|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.054
91606728|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.012
91606729|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.457
91606730|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.001
91652106|NCT02232074|183196187|SUPERIORITY||Mean Difference (Final Values)|-4.83|STANDARD_DEVIATION|2.93||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
91652107|NCT02232074|183196188|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_DEVIATION|0.75||0.13|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.13
91606731|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.021
91606732|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.710
91606733|NCT00190775|183105662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||<0.001
91606734|NCT00190775|183105662|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
91606735|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.722
91652108|NCT02232074|183196189|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_DEVIATION|3.7||0.8|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.80
91606736|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.011
91606737|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
91652109|NCT01464827|183196210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.406|TWO_SIDED|95.0|0.09|2.61||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Group G|"The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).~Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors."||2.61|0.09|0.406
91652110|NCT01464827|183196211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.266|TWO_SIDED|95.0|0.08|2.02||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.02|0.08|0.266
91652111|NCT01464827|183196211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.525|TWO_SIDED|95.0|0.18|2.4||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.40|0.18|0.525
91652112|NCT01464827|183196211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.375|TWO_SIDED|95.0|0.55|4.92||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + K + L\] : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||4.92|0.55|0.375
91652113|NCT01464827|183196212|SUPERIORITY_OR_OTHER||Difference|-12.16||||0.068|TWO_SIDED|95.0|-25.2|0.88||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group B - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.88|-25.20|0.068
91652114|NCT01464827|183196212|SUPERIORITY_OR_OTHER||Difference|-6.75||||0.065|TWO_SIDED|95.0|-13.93|0.43||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Groups \[C + D + J\] - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.43|-13.93|0.065
91606738|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-Value for Hyper/Impulsive Scale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.779
91652115|NCT01464827|183196213|SUPERIORITY_OR_OTHER||Difference|-7.13||||0.106|TWO_SIDED|95.0|-15.77|1.51||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group E - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||1.51|-15.77|0.106
91606739|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
91606740|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.002
91606741|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.716
91606742|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.071
91606743|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.034
91652116|NCT01464827|183196214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.616|TWO_SIDED|95.0|0.37|5.34||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + H + I\] : Groups \[K + L + M + N\]|The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.||5.34|0.37|0.616
91606744|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.938||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.938
91606745|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
91606746|NCT00190775|183105663|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
91652117|NCT01075763|183196215|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.64
91652118|NCT01075763|183196215|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.92
91652119|NCT01075763|183196216|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.63
91652120|NCT01075763|183196216|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
91652121|NCT01075763|183196217|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.45
91652122|NCT01075763|183196217|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.88
91652123|NCT01075763|183196217|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
91652124|NCT01075763|183196217|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.81
91652125|NCT01075763|183196218|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.29
91652126|NCT01075763|183196218|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.36
91652127|NCT01075763|183196218|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
91652128|NCT01075763|183196218|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.41
91652129|NCT01075763|183196219|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.86
91652130|NCT01075763|183196219|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.62
91652131|NCT01075763|183196219|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.21
91652132|NCT01075763|183196220|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.95
91652133|NCT01075763|183196220|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.73
91652134|NCT01075763|183196220|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.30
91652135|NCT01075763|183196222|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.80
91652136|NCT01075763|183196222|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
91652137|NCT01075763|183196222|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.12
91606747|NCT00190775|183105664|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.546
91606748|NCT00190775|183105664|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.530
91606749|NCT00190775|183105664|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.569
91606750|NCT00190775|183105664|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||P-Vaue for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.986
91606751|NCT00327444|183105684|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|31.8|STANDARD_ERROR_OF_MEAN|10.59||0.0019|TWO_SIDED|95.0|10.56|53.05||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||53.05|10.56|0.0019
91606752|NCT00327444|183105685|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|375.5|STANDARD_ERROR_OF_MEAN|205.99||0.016|TWO_SIDED|95.0|-46.48|797.42||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference was estimated for aflibercept versus placebo (aflibercept-placebo).|||797.42|-46.48|0.0160
91606753|NCT00327444|183105686|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.94||0.0035|TWO_SIDED|95.0|-4.33|-0.54||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||-0.54|-4.33|0.0035
91652138|NCT01075763|183196223|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.53
91652139|NCT01075763|183196223|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.85
91652140|NCT01075763|183196223|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.85
91652141|NCT00586521|183196224|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was analyzed by paired t-test and Wilcoxon test (number of joint bleeds prophylaxis treatment compared to number of joint bleeds on-demand treatment) at 6 months of treatment.||||<0.001
91652142|NCT00586521|183196224|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The maximum individual reduction in the actual number of joint bleeds after the switch to prophylactic treatment was analyzed by a paired t-test of the individual difference between prophylaxis treatment bleed compared to on-demand treatment bleeds.||||<0.001
91652143|NCT00586521|183196225|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||paired t-test (prophylaxis compared to on-demand) at 6 months of treatment.||||<0.001
91652144|NCT00586521|183196226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The Gilbert Score was the sum of 3 scores: pain (0=no pain to 3=severe pain); bleeding score (0=none to 3=3 or more major bleeds or 7 or more minor bleeds); and physical score (based on swelling, muscle atrophy; and axial deformity (at knee or ankle), range of motion, crepitus on motion, flexion contracture, instability.||||<0.001
91652145|NCT00586521|183196227|SUPERIORITY_OR_OTHER|||||||0.314||||||The alpha level for a significant P-value was pre-defined at 5%.|paired t-test|||"The Haemo-QoL A questionnaire measures the subject's self-assessment of disease impact on physical functioning, role functioning, worry, consequences, positive affect, and treatment concern."||||0.314
91652146|NCT01633827|183196234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91652147|NCT01633827|183196235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.025|TWO_SIDED||||||t-test, 2 sided|||||||0.025
91652148|NCT01633827|183196236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
91652149|NCT01633827|183196237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
91652150|NCT01633827|183196238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91652151|NCT05431153|183196249|OTHER||Ratio of adjusted geometric means|98.83|||||TWO_SIDED|90.0|94.0|103.91|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||103.91|94.00|
91652152|NCT05431153|183196249|OTHER||Ratio of adjusted geometric means|98.02|||||TWO_SIDED|90.0|93.88|102.35|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.35|93.88|
91606754|NCT01658514|183105688|SUPERIORITY_OR_OTHER||% Ratio of LS Means|51.5||||0.0011|TWO_SIDED|90.0|37.77|70.23||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||70.23|37.77|0.0011
91606755|NCT01658514|183105688|SUPERIORITY_OR_OTHER||% Ratio of LS Means|73.8||||0.0733|TWO_SIDED|90.0|55.97|97.43||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||97.43|55.97|0.0733
91606756|NCT01658514|183105688|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.7||||0.0028|TWO_SIDED|90.0|42.25|76.1||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||76.10|42.25|0.0028
91652153|NCT05431153|183196249|OTHER||Ratio of adjusted geometric means|98.51|||||TWO_SIDED|90.0|91.79|105.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||105.73|91.79|
91606757|NCT01658514|183105688|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.4||||0.0025|TWO_SIDED|90.0|37.61|73.02||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||73.02|37.61|0.0025
91652154|NCT05431153|183196250|OTHER||Ratio of adjusted geometric means|96.35|||||TWO_SIDED|90.0|87.48|106.12|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.12|87.48|
91652155|NCT05431153|183196250|OTHER||Ratio of adjusted geometric means|93.47|||||TWO_SIDED|90.0|85.65|102.0|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.00|85.65|
91652156|NCT05431153|183196250|OTHER||Ratio of adjusted geometric means|98.01|||||TWO_SIDED|90.0|89.86|106.9|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.90|89.86|
91652157|NCT05431153|183196251|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|99.55|124.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||124.93|99.55|
91652158|NCT05431153|183196251|OTHER||Ratio of adjusted geometric means|98.38|||||TWO_SIDED|90.0|90.68|106.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.73|90.68|
91652159|NCT05431153|183196252|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|96.46|128.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||128.93|96.46|
91652160|NCT05431153|183196252|OTHER||Ratio of adjusted geometric means|81.39|||||TWO_SIDED|90.0|75.06|88.26|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||88.26|75.06|
91652161|NCT00678392|183196258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665|||<|0.0001|TWO_SIDED|95.0|0.544|0.812||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.|Log Rank|||||0.812|0.544|<0.0001
91652162|NCT00678392|183196259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.3744|TWO_SIDED|95.0|0.8|1.174|||Log Rank|P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.||||1.174|0.800|0.3744
91652163|NCT00678392|183196260|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.056||||0.0001|TWO_SIDED|95.0|1.408|3.003|||Cochran-Mantel-Haenszel|P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.||||3.003|1.408|0.0001
91652164|NCT00782509|183196293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.116|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.185|0.116|<0.0001
91652165|NCT00782509|183196293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.11|0.177|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.177|0.110|<0.0001
91652166|NCT00782509|183196294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.019||0.0116||95.0|0.011|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|0.011|0.0116
91652167|NCT00782509|183196294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0095||95.0|0.012|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.012|0.0095
91652168|NCT00782509|183196295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.057|0.162|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.162|0.057|<0.0001
91652169|NCT00782509|183196295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.027||0.0011||95.0|0.036|0.143|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.143|0.036|0.0011
91652170|NCT00782509|183196296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.131|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.131|<0.0001
91788052|NCT02054481|183456467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1||||0.0062|TWO_SIDED|95.0|6.0|36.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 24||36.2|6.0|0.0062
91606758|NCT01658514|183105689|SUPERIORITY_OR_OTHER||% Ratio of LS Means|65.5||||0.0474|TWO_SIDED|90.0|46.32|92.68||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||92.68|46.32|0.0474
91606759|NCT01658514|183105689|SUPERIORITY_OR_OTHER||% Ratio of LS Means|77.3||||0.1691|TWO_SIDED|90.0|56.72|105.41||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||105.41|56.72|0.1691
91606760|NCT01658514|183105689|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.6||||0.0064|TWO_SIDED|90.0|40.73|78.63||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||78.63|40.73|0.0064
91606761|NCT01658514|183105689|SUPERIORITY_OR_OTHER||% Ratio of LS Means|54.6||||0.0097|TWO_SIDED|90.0|37.68|79.11||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||79.11|37.68|0.0097
91606762|NCT01658514|183105690|SUPERIORITY_OR_OTHER|||||||0.9444|TWO_SIDED|||||R² for Placebo-adjusted Change from Pre-dose Value in Lactate Versus Metformin Concentration|Pearson Correlation|||||||0.9444
91606763|NCT01658514|183105690|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||R² for placebo-adjusted change from pre-dose value in lactate versus metformin concentration|Pearson Correlation|||||||<0.0001
91606764|NCT00332202|183105691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.541|TWO_SIDED|95.0|0.689|1.216|||Log Rank|||||1.216|0.689|0.541
91606765|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 2||||0.606
91606766|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 4||||0.971
91606767|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.580
91606768|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 12||||0.265
91606769|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 18||||0.460
91652171|NCT00782509|183196296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.138|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.138|<0.0001
91652172|NCT00782509|183196297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.13|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.130|<0.0001
91652173|NCT00782509|183196297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.186|0.119|<0.0001
91652174|NCT00782509|183196298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.135|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.135|<0.0001
91788053|NCT02054481|183456468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.1||||0.0008|TWO_SIDED|95.0|11.3|42.9|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||42.9|11.3|0.0008
91606770|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.441|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.441
91606771|NCT00332202|183105697|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 36||||0.357
91606772|NCT00332202|183105698|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.267
91606773|NCT00332202|183105698|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.807
91606774|NCT00332202|183105698|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 33||||0.864
91606775|NCT00332202|183105699|SUPERIORITY||Hazard Ratio (HR)|0.768||||0.4|TWO_SIDED|95.0|0.415|1.42|||Regression, Cox|||||1.420|0.415|0.400
91606776|NCT00332202|183105699|SUPERIORITY||Hazard Ratio (HR)|1.309||||0.539|TWO_SIDED|95.0|0.557|3.08|||Regression, Cox|||||3.080|0.557|0.539
91606777|NCT00332202|183105700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.775||||0.084|TWO_SIDED|95.0|0.947|3.329|||Regression, Cox|||||3.329|0.947|0.084
91606778|NCT00332202|183105700|SUPERIORITY||Hazard Ratio (HR)|1.286||||0.585|TWO_SIDED|95.0|0.527|3.137|||Regression, Cox|||||3.137|0.527|0.585
91606779|NCT02370121|183105702|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91606780|NCT02370121|183105703|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91606781|NCT02370121|183105704|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91606782|NCT02370121|183105705|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91652175|NCT00782509|183196298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.127|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.127|<0.0001
91606783|NCT02370121|183105706|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91606784|NCT02370121|183105707|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91606785|NCT02370121|183105708|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91606786|NCT02370121|183105709|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91606787|NCT02370121|183105710|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91606788|NCT02370121|183105711|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91606789|NCT02370121|183105712|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91606790|NCT02370121|183105713|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
91606791|NCT02370121|183105714|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91606792|NCT02370121|183105715|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91606793|NCT02370121|183105716|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91606794|NCT02370121|183105717|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91606795|NCT02370121|183105718|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91606796|NCT03128957|183105738|EQUIVALENCE|Given the small sample permutation are feasible.||||||0.036|||||||permutation test|Given the non-parametric nature of spearman's correlation coefficient and a small sample we used a permutation test to calculate p-values.||Non-parametric covariance adjusted Spearman's correlation ρ\_s. To test the Null that Ho: ρ\_s.=0 vs alternative that Ha: ρ\_s.≠0, we used a method that calculates the probability that it would be greater than or equal to the observed ρ ̂, given the null hypothesis, by using a permutation test. An advantage of this approach is that it automatically takes into account the number of tied data values in the sample and the way they are treated in computing the rank correlation.||||0.036
91606797|NCT03128957|183105739|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.015
91606798|NCT03128957|183105740|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.047
91606799|NCT00684177|183105741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.4||||0.098|TWO_SIDED|95.0|-1.6|18.4|||Chi-squared|||||18.4|-1.6|0.098
91606800|NCT00684177|183105742|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
91606801|NCT00684177|183105743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
91606802|NCT03093155|183105802|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|90.0|0.2|0.49|||Regression, Cox|||||0.49|0.20|<0.001
91606803|NCT03093155|183105803|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
91606804|NCT03093155|183105804|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.018|TWO_SIDED|90.0|0.38|0.84|||Regression, Cox|||||0.84|0.38|0.018
91606805|NCT03093155|183105805|SUPERIORITY|||||||0.77|||||||Fisher Exact|||||||0.77
91606806|NCT03093155|183105806|SUPERIORITY|||||||0.068|||||||Fisher Exact|||The RECIST responses were categorized as SD/PD or NA compared to PR or Better as a binary outcome.||||0.068
91606807|NCT01075178|183105811|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.81|||||ONE_SIDED|95.0||0.96|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.96||
91606808|NCT01075178|183105812|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.8|||||ONE_SIDED|95.0||0.95|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.95||
91652176|NCT00782509|183196299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.131|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.200|0.131|<0.0001
91652177|NCT00782509|183196299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.102|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.102|<0.0001
91606809|NCT01075178|183105813|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|1.05|||||ONE_SIDED|95.0||1.64|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||1.64||
91613704|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.76|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.||1.25|0.76|0.84
91613705|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.81||||0.07|TWO_SIDED|95.0|0.64|1.02||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.||1.02|0.64|0.07
91613706|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.42|0.82||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.||0.82|0.42|0.002
91613707|NCT02078713|183121556|SUPERIORITY||Odds Ratio (OR)|0.58||||0.005|TWO_SIDED|95.0|0.4|0.85||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.||0.85|0.4|0.005
91613708|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.55||||0.27|TWO_SIDED|95.0|0.71|3.42||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of hormonal IUD||3.42|0.71|0.27
91613709|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.65||||0.18|TWO_SIDED|95.0|0.8|3.4||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of non-hormonal IUD||3.40|0.80|0.18
91613710|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5|TWO_SIDED|95.0|0.62|2.69||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of implant||2.69|0.62|0.5
91613711|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.7||||0.32|TWO_SIDED|95.0|0.59|4.89||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of the patch||4.89|0.59|0.32
91613712|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.38||||0.37|TWO_SIDED|95.0|0.68|2.81||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of ring||2.81|0.68|0.37
91613713|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of male sterilization (vasectomy)||3.73|0.60|0.39
91613714|NCT02078713|183121557|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of female sterilization||3.73|0.6|0.39
91652178|NCT00782509|183196300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.127|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.127|<0.0001
91652179|NCT00782509|183196300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.123|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.123|<0.0001
91652180|NCT00782509|183196301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.018||0.0043||95.0|0.017|0.089|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.089|0.017|0.0043
91652181|NCT00782509|183196301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.018||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.028|0.0005
91652182|NCT00782509|183196302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.037|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.110|0.037|<0.0001
91652183|NCT00782509|183196302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.049|0.121|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.121|0.049|<0.0001
91652184|NCT00782509|183196303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0002
91652185|NCT00782509|183196303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0186||95.0|0.007|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.081|0.007|0.0186
91652186|NCT00782509|183196304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0003
91652187|NCT00782509|183196304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.002||95.0|0.021|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.095|0.021|0.0020
91652188|NCT00782509|183196305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.02|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.020|0.0024
91652189|NCT00782509|183196305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.019||0.1614||95.0|-0.011|0.064|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.064|-0.011|0.1614
91652190|NCT00782509|183196306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.025|0.0012
91652191|NCT00782509|183196306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.034|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.109|0.034|0.0002
91652192|NCT00782509|183196307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.019||0.0004||95.0|0.031|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.031|0.0004
91652193|NCT00782509|183196307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.033|0.108|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.108|0.033|0.0002
91652194|NCT00782509|183196308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.132|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.132|<0.0001
91788054|NCT02054481|183456469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.1||||0.0706|TWO_SIDED|95.0|-0.8|21.1|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||21.1|-0.8|0.0706
91788055|NCT02054481|183456470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.8||||0.03|TWO_SIDED|95.0|1.9|37.7|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||37.7|1.9|0.0300
91788056|NCT02054481|183456472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2||||0.0072|TWO_SIDED|95.0|5.7|36.6|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||36.6|5.7|0.0072
91652195|NCT00782509|183196308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.142|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.142|<0.0001
91652196|NCT00782509|183196309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.190|0.119|<0.0001
91652197|NCT00782509|183196309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.111|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.111|<0.0001
91652198|NCT00782509|183196310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
91652199|NCT00782509|183196310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.13|0.202|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.202|0.130|<0.0001
91652200|NCT00782509|183196311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.108|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.108|<0.0001
91652201|NCT00782509|183196311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.094|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.094|<0.0001
91709776|NCT02700425|183312173|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
91709777|NCT02700425|183312173|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
91788057|NCT02054481|183456473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1844|||<|0.0001|TWO_SIDED|95.0|0.1|0.4|||Log Rank|||||0.4|0.1|<0.0001
91652202|NCT00782509|183196312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
91523468|NCT02007434|182922675|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.06|STANDARD_ERROR_OF_MEAN|0.55||0.914|TWO_SIDED|95.0|-1.03|1.15|||ANCOVA||Paradigm 2 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.15|-1.03|0.9140
91652203|NCT00782509|183196312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.098|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.098|<0.0001
91652204|NCT00782509|183196313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.118|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.192|0.118|<0.0001
91652205|NCT00782509|183196313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.120|<0.0001
91652206|NCT00782509|183196314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.263|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.399|0.263|<0.0001
91652207|NCT00782509|183196314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.265|0.4|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.400|0.265|<0.0001
91788058|NCT00528970|183456483|OTHER||Mean Difference (Final Values)|2.0||||0.944||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.944
91606810|NCT01075178|183105814|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.9|||||ONE_SIDED|95.0||2.19|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||2.19||
91606811|NCT03431012|183105831|OTHER||||||>|0.05||||||Sidak corrections were used to adjust for multiple analyses.|ANCOVA|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean intentions differed between groups.||We predicted that Virus Agency (VA) and Positive Framing (PF) would lead to greater adherence intentions, compared to the human agency (HA) and negative framing (NF) versions respectively.||||>.05
91606812|NCT03431012|183105832|OTHER||||||=|0.113||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher worry than the human agency assignment.||||=.113
91606813|NCT03431012|183105833|OTHER||||||=|0.809||||||Sidak corrections were used to adjust for multiple analyses|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the human agency assignment.||||=.809
91606814|NCT03431012|183105834|OTHER|||||||0.025||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the human agency assignment.||||0.025
91606815|NCT03431012|183105835|OTHER||||||=|0.199||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that the Agency Assignment would not affect self-efficacy, i.e. people's perceived ability to use the antivirals as recommended.||||=0.199
91652208|NCT00782509|183196315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.174|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.174|<0.0001
91606816|NCT03431012|183105836|OTHER||||||=|0.484||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy.||||=0.484
91606817|NCT03431012|183105837|OTHER||||||=|0.494||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to Negative Framing.||||=0.494
91652209|NCT00782509|183196315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.159|0.294|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.294|0.159|<0.0001
91652210|NCT00782509|183196316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.195|0.332|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.332|0.195|<0.0001
91652211|NCT00782509|183196316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.178|0.315|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.315|0.178|<0.0001
91606818|NCT01748799|183105840|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||<0.01
91606819|NCT01748799|183105840|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||0.01
91652212|NCT00782509|183196317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.17|0.308|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.308|0.170|<0.0001
91652213|NCT00782509|183196317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.176|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.314|0.176|<0.0001
91652214|NCT00782509|183196318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.171|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.311|0.171|<0.0001
91652215|NCT00782509|183196318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.15|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.289|0.150|<0.0001
91606820|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 2 between the two arms."|Difference in Change|-0.32||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two arms"||||0.02
91652216|NCT00782509|183196319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.147|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.147|<0.0001
91788059|NCT00528970|183456483|OTHER||Mean Difference (Final Values)|9.1||||0.208||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.208
91788060|NCT02882152|183456487|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
91606821|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean problems maintaining an erection score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in problems maintaining an erection score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two arms"||||0.11
91606822|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two arms"||||0.02
91606823|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two arms"||||0.01
91606824|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 2 between the two arms."|Difference in Change|-0.28||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two arms"||||0.01
91606825|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 2 between the two arms."|Difference in Change|-0.24||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two arms"||||0.02
91606826|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 2 between the two arms."|Difference in Change|-0.19||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two arms"||||0.11
91652217|NCT00782509|183196319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.148|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.148|<0.0001
91652218|NCT00782509|183196320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.037||0.104||95.0|-0.012|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|-0.012|0.1040
91788061|NCT02882152|183456488|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
91788062|NCT02788279|183456624|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9871|TWO_SIDED|95.0|0.73|1.38|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.38|0.73|0.9871
91788063|NCT02788279|183456624|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.336|TWO_SIDED|95.0|0.83|1.71|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.71|0.83|0.3360
91606827|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 2 between the two arms."|Difference in Change|-0.16||||0.21|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two arms"||||0.21
91606828|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 2 between the two arms."|Difference in Change|-0.14||||0.33|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two arms"||||0.33
91652219|NCT00782509|183196320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.036||0.0172||95.0|0.015|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.158|0.015|0.0172
91652220|NCT00782509|183196321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.037||0.0106||95.0|0.022|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.166|0.022|0.0106
91652221|NCT00782509|183196321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.046|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.046|0.0013
91652222|NCT00782509|183196322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.037||0.3821||95.0|-0.04|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|-0.040|0.3821
91652223|NCT00782509|183196322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.037||0.1917||95.0|-0.024|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.120|-0.024|0.1917
91652224|NCT00782509|183196323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.037||0.1808||95.0|-0.023|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|-0.023|0.1808
91652225|NCT00782509|183196323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.037||0.37||95.0|-0.039|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|-0.039|0.3700
91652226|NCT00782509|183196324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.037||0.2312||95.0|-0.029|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|-0.029|0.2312
91652227|NCT00782509|183196324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0596||95.0|-0.003|0.144|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.144|-0.003|0.0596
91652228|NCT00782509|183196325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.311||95.0|-0.036|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.111|-0.036|0.3110
91652229|NCT00782509|183196325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.038||0.9426||95.0|-0.076|0.071|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.071|-0.076|0.9426
91652230|NCT00782509|183196326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.038||0.268||95.0|-0.032|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.115|-0.032|0.2680
91652231|NCT00782509|183196326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0662||95.0|-0.005|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.005|0.0662
91652232|NCT00782509|183196327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.038||0.2249||95.0|-0.028|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|-0.028|0.2249
91788064|NCT02788279|183456624|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9686|TWO_SIDED|95.0|0.74|1.38|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.38|0.74|0.9686
91788065|NCT02788279|183456624|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3553|TWO_SIDED|95.0|0.83|1.69|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.69|0.83|0.3553
91788066|NCT02788279|183456625|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1208|TWO_SIDED|95.0|0.94|1.65|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.65|0.94|0.1208
91709778|NCT02700425|183312174|OTHER|paired t-test||||||0.002||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
91709779|NCT02700425|183312174|OTHER|paired t-test||||||0.002|||||||t-test, 2 sided|||Primary outcome of His Bundle Pacing was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
91709780|NCT02700425|183312175|OTHER|Log rank test of a survival analysis||||||0.62||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular hospitalization or death by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.62
91709781|NCT02700425|183312176|OTHER|||||||0.09||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of Coronary Sinus Pacing arm was presented at baseline as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon sign rank test.||||0.09
91709782|NCT02700425|183312176|OTHER|||||||0.32||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of the His Bundle Pacing arm was presented at baseline and 12 months as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon sign rank test.||||0.32
91709783|NCT02700425|183312177|OTHER|||||||0.35||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with His Bundle Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.35
91709784|NCT02700425|183312177|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with Coronary Sinus Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.07
91788067|NCT02788279|183456625|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0509|TWO_SIDED|95.0|1.0|1.94|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.94|1.00|0.0509
91606829|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two arms"||||0.46
91606830|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two arms"||||0.46
91709785|NCT02700425|183312178|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular rehospitalization by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
91709786|NCT02700425|183312179|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first treated VT/VF by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
91709787|NCT01462305|183312221|SUPERIORITY_OR_OTHER|||||||0.74||||||interaction effect and week of treatment condition|ANOVA|||To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the \~465nm (shorter wavelength) source compared with the \~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (\~465nm vs. \~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.||||0.74
91709788|NCT01462305|183312221|SUPERIORITY_OR_OTHER|||||||0.9||||||A repeated-measures ANOVA on the 29 subjects revealed no significant effect or interaction effect|ANOVA|||||||0.9
91709789|NCT01462305|183312221|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A repeated-measures ANOVA on the 29 subjects revealed significant effect of treatment week|ANOVA|||||||<0.0001
91709790|NCT01462305|183312223|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.20
91709791|NCT00169104|183312232|SUPERIORITY||Mean Difference (Net)|-0.2|||>|0.05|TWO_SIDED|||||t=-0.29|t-test, 2 sided|df=15||T test||||>0.05
91709792|NCT02020889|183312248|OTHER||Odds Ratio (OR)|5.91|||<|0.001|TWO_SIDED|95.0|2.68|13.03|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||13.03|2.68|<0.001
91652233|NCT00782509|183196327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.038||0.0994||95.0|-0.012|0.136|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.136|-0.012|0.0994
91652234|NCT00782509|183196328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.332|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.261|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.403|0.261|<0.0001
91652235|NCT00782509|183196328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.263|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.403|0.263|<0.0001
91709793|NCT02020889|183312249|OTHER||Odds Ratio (OR)|16.74|||<|0.001|TWO_SIDED|95.0|3.61|77.56|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||77.56|3.61|<0.001
91606831|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 2 between the two arms."|Difference in Change|-0.07||||0.58|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two arms"||||0.58
91606832|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 2 between the two arms."|Difference in Change|0.01||||0.92|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two arms"||||0.92
91606833|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 2 between the two arms."|Difference in Change|0.02||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two arms"||||0.84
91606834|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 2 between the two arms."|Difference in Change|0.03||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two arms"||||0.83
91606835|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 2 between the two arms."|Difference in Change|0.04||||0.72|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two arms"||||0.72
91606836|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 2 between the two arms."|Difference in Change|0.06||||0.48|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two arms"||||0.48
91652236|NCT00782509|183196329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.153|0.296|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.296|0.153|<0.0001
91652237|NCT00782509|183196329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.139|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.139|<0.0001
91652238|NCT00782509|183196330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.196|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.340|0.196|<0.0001
91709794|NCT02020889|183312250|OTHER||Hazard Ratio (HR)|0.322|||<|0.001|TWO_SIDED|95.0|0.206|0.502|||Cox Proportional Hazard regression|Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||0.502|0.206|<0.001
91709795|NCT02020889|183312251|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.41|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||0.41|0.09|<0.001
91709796|NCT02020889|183312252|OTHER||Odds Ratio (OR)|19.65||||0.007|TWO_SIDED|95.0|2.3|167.93|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||167.93|2.30|0.007
91709797|NCT02020889|183312253|OTHER||Odds Ratio (OR)|5.31|||<|0.001|TWO_SIDED|95.0|2.63|10.74|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||10.74|2.63|<0.001
91606837|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 2 between the two arms."|Difference in Change|0.08||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two arms"||||0.54
91606838|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 2 between the two arms."|Difference in Change|0.09||||0.56|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two arms"||||0.56
91606839|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 2 between the two arms."|Difference in Change|0.1||||0.22|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two arms"||||0.22
91652239|NCT00782509|183196330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.179|0.323|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.323|0.179|<0.0001
91652240|NCT00782509|183196331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.154|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.298|0.154|<0.0001
91652241|NCT00782509|183196331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.137|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.137|<0.0001
91652242|NCT00782509|183196332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.153|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.153|<0.0001
91709798|NCT02020889|183312254|OTHER||Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.6|19.87|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||19.87|2.60|<0.001
91788068|NCT02788279|183456625|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.1726|TWO_SIDED|95.0|0.92|1.6|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.60|0.92|0.1726
91652243|NCT00782509|183196332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.279|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.279|0.133|<0.0001
91709799|NCT02020889|183312255|OTHER||Odds Ratio (OR)|11.39||||0.003|TWO_SIDED|95.0|2.35|55.24|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.|Mepolizumab 300mg/Placebo|||55.24|2.35|0.003
91709800|NCT00809094|183312275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.14|TWO_SIDED|95.0|-0.07|0.48|||t-test, 2 sided|||Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)||0.48|-0.07|0.14
91709801|NCT04676724|183312353|OTHER||Difference in SVR Rate|-3.0|||||TWO_SIDED|95.0|-29.0|11.0|||||The point estimate of SVR and its 95% highest posterior density Credible Interval (CI) are estimated from a Bayesian model that incorporates the analysis stratification factors and treatment arm.|||11|-29|
91788069|NCT02788279|183456625|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0467|TWO_SIDED|95.0|1.0|1.91|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.91|1.00|0.0467
91606840|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 2 between the two arms."|Difference in Change|0.11||||0.4|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two arms"||||0.40
91606841|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 2 between the two arms."|Difference in Change|0.13||||0.35|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two arms"||||0.35
91606842|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 2 between the two arms."|Difference in Change|0.17||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two arms"||||0.11
91606843|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two arms"||||0.11
91652244|NCT00782509|183196333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.280|0.133|<0.0001
91652245|NCT00782509|183196333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.138|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.285|0.138|<0.0001
91652246|NCT00782509|183196334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.047||0.0028||95.0|0.049|0.235|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.235|0.049|0.0028
91652247|NCT00782509|183196334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.048||0.0013||95.0|0.061|0.25|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.250|0.061|0.0013
91652248|NCT00782509|183196335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.36|STANDARD_ERROR_OF_MEAN|4.959||0.0072|TWO_SIDED|95.0|3.622|23.099|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||23.099|3.622|0.0072
91652249|NCT00782509|183196335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.934|STANDARD_ERROR_OF_MEAN|4.894|<|0.0001|TWO_SIDED|95.0|11.323|30.545|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.545|11.323|<0.0001
91709802|NCT00237692|183312361|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.7|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.7|
91652250|NCT00782509|183196336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.456|STANDARD_ERROR_OF_MEAN|5.201||0.0169|TWO_SIDED|95.0|2.242|22.67|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||22.670|2.242|0.0169
91652251|NCT00782509|183196336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.653|STANDARD_ERROR_OF_MEAN|5.132|<|0.0001|TWO_SIDED|95.0|10.574|30.731|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.731|10.574|<0.0001
91652252|NCT00782509|183196337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.416|STANDARD_ERROR_OF_MEAN|0.127||0.0011|TWO_SIDED|95.0|-0.665|-0.167|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.167|-0.665|0.0011
91652253|NCT00782509|183196337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.125|<|0.0001|TWO_SIDED|95.0|-0.76|-0.267|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.267|-0.760|<0.0001
91709803|NCT00237692|183312361|SUPERIORITY_OR_OTHER||Est. % of patients with controled SBP|59.8|||||TWO_SIDED|95.0|55.7|64.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||64.0|55.7|
91709804|NCT00237692|183312361|SUPERIORITY_OR_OTHER||Est. % of patinets with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at Baseline||63.9|55.6|
91606844|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.15|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two arms"||||0.15
91606845|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 2 between the two arms."|Difference in Change|0.22||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two arms"||||0.08
91606846|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 2 between the two arms."|Difference in Change|0.34||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two arms"||||0.02
91606847|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.36||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two arms"||||0.01
91652254|NCT00782509|183196338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.157||0.0077|TWO_SIDED|95.0|-0.729|-0.111|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.111|-0.729|0.0077
91652255|NCT00782509|183196338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001||95.0|-1.065|-0.456|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.456|-1.065|<0.0001
91652256|NCT00782509|183196339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|0.252||0.001|TWO_SIDED|95.0|-1.333|-0.342|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.342|-1.333|0.0010
91652257|NCT00782509|183196339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.278|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|-1.767|-0.789|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.789|-1.767|<0.0001
91652258|NCT00782509|183196340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0122
91652259|NCT00782509|183196340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0008||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0008
91652260|NCT00782509|183196341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0028||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0028
91788070|NCT02788279|183456626|SUPERIORITY||Difference in Response Rates|0.51||||1|TWO_SIDED|95.0|-3.92|4.94|||Stratified Cochrane-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.94|-3.92|1.0000
91652261|NCT00782509|183196341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0169||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.0|-0.5|0.0169
91652262|NCT00782509|183196342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.018||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.0|-0.5|0.0180
91652263|NCT00782509|183196342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0015||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0015
91652264|NCT00782509|183196343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1313||95.0|-0.4|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.1313
91652265|NCT00782509|183196343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0089||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0089
91652266|NCT00782509|183196344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993|STANDARD_ERROR_OF_MEAN|0.187||0.9853|TWO_SIDED|95.0|0.687|1.436|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.436|0.687|0.9853
91652267|NCT00782509|183196344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|STANDARD_ERROR_OF_MEAN|0.222||0.2344|TWO_SIDED|95.0|0.873|1.763|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.763|0.873|0.2344
91606848|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 3 between the two arms."|Difference in Change|-0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two arms"||||0.08
91652268|NCT00782509|183196345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.438||0.9035|TWO_SIDED|95.0|0.463|2.38|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||2.380|0.463|0.9035
91652269|NCT00782509|183196345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|STANDARD_ERROR_OF_MEAN|0.408||0.9304|TWO_SIDED|95.0|0.415|2.209|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.209|0.415|0.9304
91652270|NCT00782509|183196346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|STANDARD_ERROR_OF_MEAN|0.233||0.669|TWO_SIDED|95.0|0.717|1.657|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.657|0.717|0.6690
91652271|NCT00782509|183196346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.344|STANDARD_ERROR_OF_MEAN|0.273||0.1437|TWO_SIDED|95.0|0.902|2.002|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.002|0.902|0.1437
91652272|NCT00782509|183196347|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.188|STANDARD_ERROR_OF_MEAN|0.2251||0.3637|TWO_SIDED|95.0|0.8188|1.7234|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7234|0.8188|0.3637
91652273|NCT00782509|183196347|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2822|STANDARD_ERROR_OF_MEAN|0.2403||0.1853|TWO_SIDED|95.0|0.8874|1.8527|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.8527|0.8874|0.1853
91652274|NCT00782509|183196348|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0314|STANDARD_ERROR_OF_MEAN|0.4664||0.9455|TWO_SIDED|95.0|0.4244|2.5063|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||2.5063|0.4244|0.9455
91652275|NCT00782509|183196348|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1273|STANDARD_ERROR_OF_MEAN|0.5028||0.7883|TWO_SIDED|95.0|0.4696|2.7064|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.7064|0.4696|0.7883
91652276|NCT00782509|183196349|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2846|STANDARD_ERROR_OF_MEAN|0.2803||0.2514|TWO_SIDED|95.0|0.837|1.9717|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.9717|0.8370|0.2514
91652277|NCT00782509|183196349|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.3373|STANDARD_ERROR_OF_MEAN|0.2901||0.1807|TWO_SIDED|95.0|0.8735|2.0474|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0474|0.8735|0.1807
91652278|NCT03151499|183196369|OTHER||Geometric mean (gMean) ratio (%)|7.8|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|5.74|10.601|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||10.601|5.740|
91652279|NCT03151499|183196370|OTHER||Geometric mean (gMean) ratio (%)|9.77|STANDARD_ERROR_OF_MEAN|1.232|||TWO_SIDED|90.0|6.767|14.098|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||14.098|6.767|
91652280|NCT03151499|183196371|OTHER||Geometric mean (gMean) ratio (%)|8.23|STANDARD_ERROR_OF_MEAN|1.187|||TWO_SIDED|90.0|6.081|11.126|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|Since the main focus is on estimation and not testing, therefore no hypothesis was tested.The statistical analysis model is an ANOVA (analysis of variance) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||11.126|6.081|
91652281|NCT01798485|183196377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.3293|TWO_SIDED|95.0|0.899|1.372|||Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.||1.372|0.899|0.3293
91709805|NCT00237692|183312361|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.6|
91709806|NCT00237692|183312362|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|58.0|||||TWO_SIDED|95.0|49.3|66.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 6 months.||66.7|49.3|
91523469|NCT02007434|182922675|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.56||0.8754|TWO_SIDED|95.0|-1.21|1.04|||ANCOVA||Paradigm 3 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.04|-1.21|0.8754
91523470|NCT01691521|182922689|SUPERIORITY_OR_OTHER||Rate Ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.72||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.72|0.40|<0.001
91523471|NCT01691521|182922689|SUPERIORITY_OR_OTHER||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 100 mg SC arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.35|<0.001
91523472|NCT00560612|182922701|SUPERIORITY|||||||0.7054|||||||t-test, 2 sided|||||||0.7054
91523473|NCT00560612|182922702|SUPERIORITY|||||||0.4583|||||||t-test, 2 sided|||||||0.4583
91523474|NCT00560612|182922703|SUPERIORITY|||||||0.7443|||||||t-test, 2 sided|||||||0.7443
91523475|NCT00560612|182922704|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
91523476|NCT00861601|182922719|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0104
91606849|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two arms"||||0.08
91523477|NCT00861601|182922719|SUPERIORITY_OR_OTHER|||||||0.0057||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0057
91523478|NCT00861601|182922719|SUPERIORITY_OR_OTHER|||||||0.0808||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0808
91523479|NCT00861601|182922720|SUPERIORITY_OR_OTHER|||||||0.0116||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0116
91523480|NCT00861601|182922720|SUPERIORITY_OR_OTHER|||||||0.0066||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0066
91523481|NCT00861601|182922720|SUPERIORITY_OR_OTHER|||||||0.0846||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0846
91523482|NCT04750655|182922746|OTHER|||||||1|||||||Kruskal-Wallis|||Used the Kruskal-Wallis (nonparametric one-way ANOVA), comparing all 3 arms. Note that for each individual, a single number (normalized read) is obtained.||||1
91523483|NCT00879996|182922751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9134||||0.77|TWO_SIDED|95.0|0.4156|2.007|||Log Rank|||Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.||2.007|0.4156|0.77
91523484|NCT00879996|182922752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.043||95.0|||||ANOVA|||Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.||||<0.043
91523485|NCT00879996|182922753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.0|<|0.665|TWO_SIDED|95.0|||||ANOVA|||null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.||||<0.665
91523486|NCT00879996|182922754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|STANDARD_DEVIATION|0.0|<|0.039|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.||||<0.039
91523487|NCT01148862|182922769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.2||||0.006|||||||ANCOVA|||||||0.006
91523488|NCT01148862|182922770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.015||95.0|||||ANCOVA|||||||0.015
91523489|NCT02583763|182922836|SUPERIORITY||||||>|0.05||||||Significance value stated as p\<0.05|t-test, 2 sided|||Paired sample T test were used to analyse normally distributed data.||||>0.05
91523490|NCT02583763|182922837|SUPERIORITY||||||>|0.05||||||Significance value was stated as p\<0.05|t-test, 2 sided|||||||>0.05
91523491|NCT02583763|182922838|SUPERIORITY|||||||0.003||||||Significance value was set to p\<0.05|t-test, 2 sided|||||||0.003
91523492|NCT03815019|182922844|SUPERIORITY||Odds Ratio, log|7.2218|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the megestrol group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
91523493|NCT03815019|182922844|SUPERIORITY||Odds Ratio, log|9.1544|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the placebo group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
91523494|NCT03815019|182922846|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED||||||||Pr(\>F) = 0.7846, Nested model using site as a predictor|||||
91606850|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two arms"||||0.08
91652282|NCT01798485|183196377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111|||||TWO_SIDED|99.5|0.821|1.503||||||"Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.~Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region)."||1.503|0.821|
91652283|NCT01798485|183196378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.161||||0.118|TWO_SIDED|95.0|0.961|1.403||Significance level of 0.05.|Log Rank|Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.||||1.403|0.961|0.1180
91606851|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean maintaining an erection score from period 1 to period 3 between the two arms."|Difference in Change|-0.13||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in maintaining an erection score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two arms"||||0.71
91606852|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 3 between the two arms."|Difference in Change|-0.11||||0.41|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two arms"||||0.41
91606853|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 3 between the two arms."|Difference in Change|-0.08||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two arms"||||0.84
91606854|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 3 between the two arms."|Difference in Change|-0.07||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two arms"||||0.71
91606855|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 3 between the two arms."|Difference in Change|-0.05||||0.88|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two arms"||||0.88
91606856|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two arms"||||0.93
91606857|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two arms"||||0.93
91652284|NCT01798485|183196379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.2506|TWO_SIDED|95.0|0.865|1.754||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.754|0.865|0.2506
91652285|NCT01798485|183196380|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.448
91652286|NCT01798485|183196381|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 6 weeks||||0.339
91606858|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.94|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two arms"||||0.94
91606859|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 3 between the two arms."|Difference in Change|0.004||||0.97|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two arms"||||0.97
91652287|NCT01798485|183196381|SUPERIORITY_OR_OTHER|||||||0.817|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 12 weeks||||0.817
91652288|NCT01798485|183196382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.344||||0.0111|TWO_SIDED|95.0|1.207|4.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||4.551|1.207|0.0111
91652289|NCT01798485|183196383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.5191|TWO_SIDED|95.0|0.797|1.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.551|0.797|0.5191
91652290|NCT01798485|183196386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.233||||0.1343|TWO_SIDED|95.0|0.937|1.621||Significance level of 0.05.|Log Rank|Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||1.621|0.937|0.1343
91709807|NCT00237692|183312362|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|60.9|||||TWO_SIDED|95.0|52.5|69.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||69.3|52.5|
91788071|NCT02788279|183456626|SUPERIORITY||Difference in Response Rates|0.0||||1|TWO_SIDED|95.0|-4.89|4.89|||Stratified Cochran-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.89|-4.89|1.0000
91788072|NCT00329849|183456643|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|38.0|||||TWO_SIDED|95.0|29.0|47.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS||47|29|
91788073|NCT00329849|183456643|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|30.0|||||TWO_SIDED|95.0|19.0|40.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS||40|19|
91523495|NCT03815019|182922847|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED||||||||Pr(\>F) = 0.7025, Nested model using site as a predictor|||||
91606860|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two arms"||||0.95
91606861|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two arms"||||0.95
91652291|NCT01798485|183196387|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.250
91652292|NCT00770991|183196409|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.||||0.065
91523496|NCT03815019|182922848|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED||||||||Pr(\>F) = 0.6764, Nested model using site as a predictor|||||
91652293|NCT00770991|183196410|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0|||||Chi-squared|||||||0.016
91652294|NCT00770991|183196411|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
91523497|NCT03815019|182922849|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7649, Nested model using site as a predictor|||||
91652295|NCT01945138|183196439|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
91652296|NCT01945138|183196440|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|||||||0.115
91652297|NCT01945138|183196441|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
91523498|NCT03815019|182922850|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||Pr(\>F) = 0.9487, Nested model using site as a predictor|||||
91652298|NCT01945138|183196442|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||t-test, 2 sided|||||||0.848
91652299|NCT01945138|183196443|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
91709808|NCT00237692|183312362|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|65.0|||||TWO_SIDED|95.0|56.9|73.1|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||73.1|56.9|
91652300|NCT01945138|183196444|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
91652301|NCT01945138|183196445|SUPERIORITY_OR_OTHER|||||||0.461|TWO_SIDED||||||t-test, 2 sided|||||||0.461
91652302|NCT01945138|183196446|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||t-test, 2 sided|||||||0.205
91791017|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.661||0.776|TWO_SIDED|95.0|-1.488|1.112||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.112|-1.488|0.776
91523499|NCT03815019|182922851|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7669, Nested model using site as a predictor|||||
91523500|NCT03815019|182922852|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED||||||||Pr(\>F) = 0.5883, Nested model using site as a predictor|||||
91606862|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 3 between the two arms."|Difference in Change|0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two arms"||||0.93
91606863|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 3 between the two arms."|Difference in Change|0.06||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two arms"||||0.84
91606864|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 3 between the two arms."|Difference in Change|0.07||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two arms"||||0.84
91606865|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 3 between the two arms."|Difference in Change|0.11||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two arms"||||0.54
91606866|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 3 between the two arms."|Difference in Change|0.14||||0.13|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two arms"||||0.13
91652303|NCT01945138|183196447|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||||||0.157
91652304|NCT01945138|183196448|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||t-test, 2 sided|||||||0.443
91652305|NCT01945138|183196449|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
91652306|NCT01945138|183196450|SUPERIORITY_OR_OTHER|||||||0.401|TWO_SIDED||||||t-test, 2 sided|||||||0.401
91652307|NCT01945138|183196451|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
91652308|NCT01945138|183196452|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
91652309|NCT01945138|183196453|SUPERIORITY_OR_OTHER|||||||0.311|TWO_SIDED||||||t-test, 2 sided|||||||0.311
91652310|NCT01132118|183196467|SUPERIORITY_OR_OTHER|||||||0.93||||||Unadjusted|Wilcoxon (Mann-Whitney)|||The P-value calculated was for the difference betweeen the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.930
91652311|NCT01132118|183196467|SUPERIORITY_OR_OTHER|||||||0.785||||||Adjusted for weight change.|Regression, Linear|||The P-value was calculated for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.785
91652312|NCT01132118|183196468|SUPERIORITY_OR_OTHER|||||||0.575||||||Unadjusted P-value|Wilcoxon (Mann-Whitney)|||P-value for the difference between change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.575
91652313|NCT01132118|183196468|SUPERIORITY_OR_OTHER|||||||0.308||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.308
91652314|NCT01132118|183196469|SUPERIORITY_OR_OTHER|||||||0.468||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference betweeen change during hydroxychloroquine versus placebo suing Wilcoxon signed-rank tests.||||0.468
91652315|NCT01132118|183196469|SUPERIORITY_OR_OTHER|||||||0.902||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.902
91652316|NCT01132118|183196470|SUPERIORITY_OR_OTHER|||||||0.004||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.004
91652317|NCT01132118|183196470|SUPERIORITY_OR_OTHER|||||||0.004||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.004
91652318|NCT01132118|183196471|SUPERIORITY_OR_OTHER|||||||0.009||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.009
91523501|NCT03815019|182922853|SUPERIORITY||Mean Difference (Final Values)|0.52|||||TWO_SIDED||||||||Pr(\>F) = 0.4749, Nested model using site as a predictor|||||
91523502|NCT03815019|182922854|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED||||||||Pr(\>F) = 0.8781, Nested model using site as a predictor|||||
91652319|NCT01132118|183196471|SUPERIORITY_OR_OTHER|||||||0.011||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.011
91652320|NCT01132118|183196472|SUPERIORITY_OR_OTHER|||||||0.73||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.730
91652321|NCT01132118|183196472|SUPERIORITY_OR_OTHER|||||||0.208||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.208
91652322|NCT01132118|183196473|SUPERIORITY_OR_OTHER|||||||0.487||||||Unadjusted P-value.|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.487
91652323|NCT01132118|183196473|SUPERIORITY_OR_OTHER|||||||0.884||||||P-value adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxycholorquine versus placebo from a linear regression model.||||0.884
91652324|NCT01644890|183196474|NON_INFERIORITY|The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (\<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.|Hazard Ratio (HR)|1.255|||||TWO_SIDED|95.0|0.989|1.592|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.||1.592|0.989|
91652325|NCT01644890|183196475|OTHER||Hazard Ratio (HR)|1.197|||||TWO_SIDED|95.0|0.885|1.62|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|||1.620|0.885|
91652326|NCT01644890|183196476|OTHER||Difference in ORR (%)|-7.5|||||TWO_SIDED|95.0|-17.4|2.7||||||||2.7|-17.4|
91606867|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 3 between the two arms."|Difference in Change|0.18||||0.18|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two arms"||||0.18
91652327|NCT03031899|183196526|NON_INFERIORITY|"1. Rose bengal should stain the areas positively stained by Toluidine blue~2. areas stained by rose bengal that shows dysplasia in biopsy"|SN, SP, PPV, NPV|||||0.005|||||||Chi-squared|||||||0.005
91652328|NCT04682444|183196540|SUPERIORITY|||||||0.5547|||||||Fisher Exact|||Day 7||||0.5547
91652329|NCT04682444|183196540|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Day 14||||<0.0001
91652330|NCT04682444|183196541|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Fisher's exact test was used for testing without adjustment for baseline status.||||0.0001
91652331|NCT04682444|183196542|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Day 3||||<0.0001
91652332|NCT04682444|183196542|SUPERIORITY|||||||0.0013|||||||Fisher Exact|||Day 7||||0.0013
91652333|NCT04682444|183196543|SUPERIORITY|||||||0.0474|||||||Fisher Exact|||Day 7||||0.0474
91652334|NCT04682444|183196543|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Day 14||||<0.0001
91652335|NCT04682444|183196544|SUPERIORITY|A mixed model repeated measurement was used, which considered baseline, treatment visit\*treatment as fixed and patient as random effect.||||||0.0065|||||||MMRM|||Day 3||||0.0065
91652336|NCT04682444|183196544|SUPERIORITY||||||<|0.0001||||||A mixed model repeated measurement was used, which considered baseline, treatment visit\*treatment as fixed and patient as random effect.|MMRM|||Day 7||||<0.0001
91652337|NCT04682444|183196544|SUPERIORITY|A mixed model repeated measurement was used, which considered baseline, treatment visit\*treatment as fixed and patient as random effect.|||||<|0.0001|||||||MMRM|||Day 14||||<0.0001
91652338|NCT04682444|183196546|SUPERIORITY|||||||0.5152|||||||Fisher Exact|||Day 3||||0.5152
91652339|NCT04682444|183196546|SUPERIORITY|||||||0.0009|||||||Fisher Exact|||Day 7||||0.0009
91652340|NCT04682444|183196546|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Day 14||||<0.0001
91652341|NCT04682444|183196547|SUPERIORITY|||||||0.1253|||||||Fisher Exact|||Day 3||||0.1253
91652342|NCT04682444|183196547|SUPERIORITY|||||||0.0611|||||||Fisher Exact|||Day 7||||0.0611
91652343|NCT04682444|183196547|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Day 14||||0.4000
91652344|NCT04682444|183196548|SUPERIORITY|||||||0.4636|||||||Fisher Exact|||Day 3||||0.4636
91652345|NCT04682444|183196548|SUPERIORITY|||||||0.1|||||||Fisher Exact|||Day 7||||0.1000
91652346|NCT04682444|183196548|SUPERIORITY|||||||0.0363|||||||Fisher Exact|||Day 14||||0.0363
91652347|NCT04682444|183196549|SUPERIORITY|||||||0.3107|||||||Fisher Exact|||Day 3||||0.3107
91652348|NCT04682444|183196549|SUPERIORITY|||||||0.0083|||||||Fisher Exact|||Day 7||||0.0083
91652349|NCT04682444|183196549|SUPERIORITY|||||||0.0611|||||||Fisher Exact|||Day 14||||0.0611
91652350|NCT04682444|183196550|SUPERIORITY|||||||0.2988|||||||Fisher Exact|||Day 3||||0.2988
91652351|NCT04682444|183196551|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||Day 3||||0.0005
91652352|NCT04682444|183196551|SUPERIORITY|||||||0.0238|||||||Fisher Exact|||Day 7||||0.0238
91652353|NCT04682444|183196551|SUPERIORITY|||||||0.0277|||||||Fisher Exact|||Day 14||||0.0277
91606868|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.19||||0.29|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two arms"||||0.29
91606869|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 3 between the two arms."|Difference in Change|0.2||||0.12|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two arms"||||0.12
91652354|NCT04682444|183196552|SUPERIORITY|||||||0.1253|||||||Fisher Exact|||Day 3||||0.1253
91652355|NCT04682444|183196552|SUPERIORITY|||||||0.0611|||||||Fisher Exact|||Day 7||||0.0611
91788074|NCT00329849|183456643|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|28.0|||||TWO_SIDED|95.0|17.0|39.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS||39|17|
91606870|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 3 between the two arms."|Difference in Change|0.24||||0.1|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two arms"||||0.10
91606871|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 3 between the two arms."|Difference in Change|0.25||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two arms"||||0.01
91606872|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 3 between the two arms."|Difference in Change|0.26||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two arms"||||0.08
91606873|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two arms"||||0.08
91613715|NCT02078713|183121558|SUPERIORITY||Odds Ratio (OR)|1.27||||0.18|TWO_SIDED|95.0|0.9|1.81||P-value calculated from multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|"The odds ratio represents the odds of the intervention group rating their appointment as much better, in the numerator, over the odds of the control group giving this rating in the denominator."|Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.||1.81|0.90|0.18
91613716|NCT02078713|183121559|SUPERIORITY||Mean Difference (Final Values)|11.81|||<|0.001|TWO_SIDED|95.0|8.54|18.66||P-value calculated in multiple imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||18.66|8.54|<0.001
91613717|NCT02078713|183121560|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.63|TWO_SIDED|95.0|-3.19|5.29||P-value calculated in multiply imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||5.29|-3.19|0.63
91613718|NCT02078713|183121561|SUPERIORITY||Observed coefficient|-3.97|STANDARD_ERROR_OF_MEAN|3.34||0.24|TWO_SIDED|95.0|-10.62|2.68|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error.|Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and site||2.68|-10.62|0.24
91613719|NCT02078713|183121561|SUPERIORITY||Observed coefficient|-1.52|STANDARD_ERROR_OF_MEAN|1.91||0.36|TWO_SIDED|95.0|-4.76|1.72|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error|Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.||1.72|-4.76|0.36
91613720|NCT02078713|183121561|SUPERIORITY||Slope|-1.64|STANDARD_ERROR_OF_MEAN|1.34||0.28|TWO_SIDED|95.0|-4.61|1.34|||Regression, Linear||Tool group compared to control group (ref). Bootstrapping used for standard error.|Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.||1.34|-4.61|0.28
91606874|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.09|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two arms"||||0.09
91606875|NCT03182738|183105862|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 3 between the two arms."|Difference in Change|0.38||||0.05|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two arms"||||0.05
91606876|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-2.09||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms||||0.83
91606877|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.94||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms||||0.83
91606878|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.79||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms||||0.83
91606879|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.78||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms||||0.83
91652356|NCT04682444|183196552|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Day 14||||0.4000
91652357|NCT04682444|183196554|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Day 14||||<0.0001
91606880|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.04||||0.98|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm"|The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms||||0.98
91606881|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.55||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.||||0.83
91606882|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.84||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.||||0.83
91606883|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|-0.43||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.||||0.96
91652358|NCT04682444|183196555|SUPERIORITY|||||||0.3973|||||||Fisher Exact|||Day 3||||0.3973
91652359|NCT04682444|183196555|SUPERIORITY|||||||0.3122|||||||Fisher Exact|||Day 7||||0.3122
91652360|NCT04682444|183196555|SUPERIORITY|||||||0.0064|||||||Fisher Exact|||Day 14||||0.0064
91652361|NCT04682444|183196557|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.012
91652362|NCT04682444|183196557|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.036
91652363|NCT04682444|183196557|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Day 14||||<0.0001
91652364|NCT04682444|183196559|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Day 3||||0.0002
91606884|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.07||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.||||0.96
91606885|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.23||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model|||The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|||0.96
91606886|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.77||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.||||0.96
91606887|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.05||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.||||0.96
91606888|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.5||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.||||0.96
91606889|NCT03182738|183105863|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|2.04||||0.64|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.||||0.64
91606890|NCT02886715|183105883|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.75|||||TWO_SIDED|90.0|94.39|103.31||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.31|94.39|
91606891|NCT02886715|183105883|SUPERIORITY||Mean Difference (Final Values)|-5.17||||0.0185|TWO_SIDED|95.0|-9.46|-0.87|||ANOVA|with treatment and site as fixed effects in the model||||-0.87|-9.46|0.0185
91606892|NCT02886715|183105885|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.39|||||TWO_SIDED|90.0|93.42|103.61||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.61|93.42|
91606893|NCT02886715|183105885|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.0354|TWO_SIDED|95.0|-8.48|-0.3|||ANOVA|with treatment and site as fixed effects in the model||||-0.30|-8.48|0.0354
91606894|NCT01128387|183105898|OTHER||Maximum Tolerated Dose|1.5|||||TWO_SIDED|||||||||Dose of Pantiumumab (in combination with Cisplatin \& Fluorouracil - see below)||||
91606895|NCT01128387|183105898|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||Dose of Cisplatin||||
91606896|NCT01128387|183105898|OTHER||Maximum Tolerated Dose|750.0|||||TWO_SIDED|||||||||Dose of Fluorourcil||||
91606897|NCT01535235|183105900|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91606898|NCT01535235|183105901|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91606899|NCT02120417|183105907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.762|TWO_SIDED|80.0|0.694|1.252|||Log Rank|The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.||||1.252|0.694|0.762
91606900|NCT01440101|183105917|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Mann-Whitney U test stratified by the presence or absence of Gd+ lesions at baseline.|Wilcoxon (Mann-Whitney)|||||||<0.001
91606901|NCT01440101|183105920|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Van Elteren test stratified by the presence or absence of Gd+ lesions at baseline.|Van Elteren test|||||||<0.001
91606902|NCT01440101|183105921|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon rank sum test|||||||0.006
91606903|NCT01440101|183105922|SUPERIORITY_OR_OTHER||Difference in proportions|0.404|||<|0.001|TWO_SIDED|95.0|0.223|0.586|||Fisher Exact|||Relapse-free proportions compared using a two-sided Fisher exact test. In the analysis, participants with unknown status are considered to have relapsed.||0.586|0.223|<0.001
91606904|NCT01440101|183105923|SUPERIORITY_OR_OTHER|||||||0.729||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline to Week 12||||0.729
91606905|NCT01440101|183105923|SUPERIORITY_OR_OTHER|||||||0.942||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline at Week 24||||0.942
91606906|NCT00885079|183105936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|2.1|<|0.05|TWO_SIDED|95.0|-1.47|-0.24||An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).|t-test, 2 sided|||||-0.24|-1.47|<0.05
91788075|NCT00329849|183456643|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|18.0|||||TWO_SIDED|95.0|8.0|28.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS||28|8|
91606907|NCT00885079|183105937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||<|0.05|||||||t-test, 2 sided|||||||<0.05
91606908|NCT03303989|183105986|SUPERIORITY|Efficacy of MMF was examined by the proportion of responders in MMF+Peg compared to PBO+Peg. Rates of the primary outcome were compared using proportions and 95% confidence intervals and tested for differences using Fisher's exact test.|||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||Fisher's exact tests were performed to compare baseline and clinical characteristics between treatment groups as appropriate.||||<0.01
91606909|NCT05202808|183106001|NON_INFERIORITY|"The endothelial cell loss (ECL) at 6 months was compared between the LAL and Control groups. The statistical hypothesis is:~* H0: Median(LAL) - Median(control) ≥ 5% vs~* Ha: Median(LAL) - Median(control) \< 5%~The median ECL for the LAL group is at most 5% higher than the median ECL for the Control group.~The first co-primary safety endpoint is met if the median ECL of the LAL group is non-inferior to the Control group using a right-tail Wilcoxon test using a significance level of 0.05."|Median Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|90.0|-1.0|1.66|||Wilcoxon (Mann-Whitney)|||With a one-sided significance level of 0.05, a power of 0.80, a randomization ratio of 2:1, and then the Mann-Whitney-Wilcoxon asymptotic relative efficiency (A.R.E.) efficiency adjustment, the sample size per two-sample t-test is 192 LAL eyes and 96 Control eyes (total of 288), with an assumed dropout rate of 10%.||1.66|-1.00|<0.0001
91606910|NCT05202808|183106003|OTHER||Odds Ratio (OR)|4.61|||||TWO_SIDED|95.0|2.97|7.15|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and Control group is the denominator. At Month 6, the odds of achieving UCDVA of 20/20 or better were 4.61 times greater for the LAL group than the Control group.|||7.15|2.97|
91606911|NCT05202808|183106004|OTHER||Odds Ratio (OR)|20.74|||||TWO_SIDED|95.0|12.05|36.14|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving Absolute MRCYL of 0.5D or less was 20.74 for the LAL group versus the Control group at month 6.|||36.14|12.05|
91606912|NCT05202808|183106005|OTHER||Odds Ratio (OR)|14.46|||||TWO_SIDED|95.0|8.89|23.57|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving simultaneous Absolute MRSE and MRCL of 0.5 D or less was 14.46 in the LAL group vs. Control at month 6.|||23.57|8.89|
91606913|NCT02747004|183106084|SUPERIORITY|||||||0.293||||||Two-sided P-value.|Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||||0.2930
91606914|NCT02747004|183106084|OTHER|Informal phase 2 non-inferiority.|Hazard Ratio (HR)|1.045|||||TWO_SIDED|95.0|0.711|1.535|||Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||1.535|0.711|
91606915|NCT03658954|183106118|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Testing for group effect.||||0.75
91606916|NCT03658954|183106119|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Testing for group effect.||||0.05
91606917|NCT03658954|183106120|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Testing for group effect.||||0.02
91606918|NCT04885257|183106123|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
91652365|NCT04682444|183196559|SUPERIORITY|||||||0.4048|||||||Fisher Exact|||Day 7||||0.4048
91652366|NCT04682444|183196560|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Day 3||||0.0002
91652367|NCT04682444|183196560|SUPERIORITY|||||||0.1614|||||||Fisher Exact|||Day 7||||0.1614
91606919|NCT00609622|183106139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.705||||0.9963|TWO_SIDED|95.0|1.272|5.751|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).||5.751|1.272|0.9963
91606920|NCT00609622|183106140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.618||||0.9289|TWO_SIDED|95.0|0.845|3.096|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).||3.096|0.845|0.9289
91606921|NCT00609622|183106143|SUPERIORITY_OR_OTHER||F-Distribution|3.956||||0.5898|TWO_SIDED|95.0|-10.412|18.324|||Chi-squared|||||18.324|-10.412|0.5898
91606922|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.0515|TWO_SIDED|95.0|-2.82|0.01|||t-test, 2 sided|||Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.82|0.0515
91652368|NCT04682444|183196561|SUPERIORITY|||||||0.5581|||||||Fisher Exact|||Day 3||||0.5581
91652369|NCT04682444|183196561|SUPERIORITY|||||||0.4167|||||||Fisher Exact|||Day 7||||0.4167
91652370|NCT04682444|183196562|SUPERIORITY|||||||0.0406|||||||Fisher Exact|||Day 3||||0.0406
91652371|NCT04682444|183196562|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Day 7||||0.2000
91652372|NCT04682444|183196563|SUPERIORITY|||||||0.2208|||||||Fisher Exact|||Day 3||||0.2208
91652373|NCT04682444|183196563|SUPERIORITY|||||||0.0659|||||||Fisher Exact|||Day 7||||0.0659
91652374|NCT04682444|183196565|SUPERIORITY|||||||0.941|||||||Fisher Exact|||Day 0, IFN-alpha||||0.941
91652375|NCT04682444|183196565|SUPERIORITY|||||||0.943|||||||Fisher Exact|||Day 0, IFN-gamma||||0.943
91652376|NCT04682444|183196565|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Day 7, IFN-alpha||||<0.001
91652377|NCT04682444|183196565|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Day 7, IFN-gamma||||<0.001
91652378|NCT04682444|183196565|SUPERIORITY|||||||0.625|||||||Fisher Exact|||Day 14, IFN-alpha||||0.625
91652379|NCT04682444|183196565|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Day 14, IFN-gamma||||<0.001
91652380|NCT00494975|183196580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.32|<|0.05|TWO_SIDED|95.0|0.31|1.56|||generalized estimating equations (GEE)|||The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.||1.56|0.31|<0.05
91652381|NCT02180061|183196599|SUPERIORITY|||||||0.0216||||||One-sided p-value. The ORR was deemed clinically meaningful if the lower bound of the 95% confidence interval exceeded 10% (p\<0.0250).|Exact Binomial Distribution|||||||0.0216
91652382|NCT01469364|183196609|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2030
91652383|NCT01469364|183196610|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2527
91652384|NCT01469364|183196615|SUPERIORITY_OR_OTHER||Mean Absolute Difference|-1.52||||0.34|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 PCS||||0.34
91652385|NCT01469364|183196615|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.78||||0.18|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 MCS||||0.18
91652386|NCT01469364|183196616|SUPERIORITY_OR_OTHER||Median Absolute Difference|1.62||||0.09|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 PCS||||0.09
91652387|NCT01469364|183196616|SUPERIORITY_OR_OTHER||Median Absolute Difference|-1.24||||0.31|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 MCS||||0.31
91709809|NCT00237692|183312362|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.8|||||TWO_SIDED|95.0|55.6|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||72.0|55.6|
91709810|NCT00237692|183312362|SUPERIORITY_OR_OTHER||% diff|2.9|||||TWO_SIDED|95.0|-9.0|14.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.||14.9|-9.0|
91709811|NCT00237692|183312362|SUPERIORITY_OR_OTHER||% Diff|6.9|||||TWO_SIDED|95.0|-4.7|18.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.||18.7|-4.7|
91652388|NCT01469364|183196617|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.82||||0.56|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ measure||||0.56
91652389|NCT01469364|183196618|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.15||||0.68|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ Measure||||0.68
91652390|NCT01469364|183196619|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.7454
91652391|NCT01469364|183196620|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||t-test, 2 sided|Paired t-test was completed.||||||0.9638
91652392|NCT02295774|183196633|SUPERIORITY_OR_OTHER||Mc Nemar's χ2 test|0.0|||||TWO_SIDED|||||||Mc Nemar's χ2 test was not applicable because there is no change between visits.|Mc Nemar's χ2 test was not applicable because there is no change between visits.|"The results of the γH2AX analysis were listed and summarised by frequency tables by visit and colonic region.~The results were compared between Visit 2 and Visit 1 for each colonic region and overall using the Mc Nemar's χ2 test.~In case of the presence of at least one positive colonic region, that visit was to be considered as 'Positive' for the overall γH2AX analysis."||||
91652393|NCT01617577|183196637|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores||||0.36
91652394|NCT01617577|183196637|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score||||0.058
91652395|NCT01617577|183196637|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PALtot trials adj at baseline vs 14wk (final visit)||||0.034
91652396|NCT03532009|183196638|SUPERIORITY|||||||0.426|||||||F-test|||The p-value was obtained by pooling the p-values from Chi-square tests performed on individual data sets using the F-distribution and reflects a global test of no difference in distribution of patients in the respective categories between SZC and placebo groups. The null hypothesis was that there is no difference between SZC and placebo in the distribution of percentage of patients in the 4 RAASi treatment categories. The hypothesis was tested at a significance level of 5%.||||0.426
91652397|NCT00368966|183196645|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.6||||||95.0|-2.9|1.6||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated||1.6|-2.9|
91709812|NCT00237692|183312362|SUPERIORITY_OR_OTHER||% Diff|5.7|||||TWO_SIDED|95.0|-6.0|17.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 6months.||17.6|-6.0|
91709813|NCT00237692|183312363|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.9|||||TWO_SIDED|95.0|51.4|68.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||68.3|51.4|
91709814|NCT00237692|183312363|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.1|||||TWO_SIDED|95.0|65.6|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months||80.7|65.6|
91709815|NCT00237692|183312363|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.4|||||TWO_SIDED|95.0|66.1|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||80.7|66.1|
91709816|NCT00237692|183312363|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|68.6|||||TWO_SIDED|95.0|60.5|76.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 12 months.||76.6|60.5|
91652398|NCT00368966|183196645|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.2||||||95.0|-2.3|4.9||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated||4.9|-2.3|
91606923|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.0876|TWO_SIDED|95.0|-3.11|0.22|||t-test, 2 sided|||Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.22|-3.11|0.0876
91606924|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.81||||0.0522|TWO_SIDED|95.0|-3.64|0.02|||t-test, 2 sided|||Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.02|-3.64|0.0522
91606925|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.1339|TWO_SIDED|95.0|-3.81|0.52|||t-test, 2 sided|||Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.52|-3.81|0.1339
91606926|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05||||0.4233|TWO_SIDED|95.0|-3.68|1.57|||t-test, 2 sided|||Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||1.57|-3.68|0.4233
91606927|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.97||||0.2211|TWO_SIDED|95.0|-5.18|1.24|||t-test, 2 sided|||Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.24|-5.18|0.2211
91606928|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.8184|TWO_SIDED|95.0|-3.22|4.04|||t-test, 2 sided|||Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||4.04|-3.22|0.8184
91606929|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9||||0.038|TWO_SIDED|95.0|0.57|17.23|||t-test, 2 sided|||Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||17.23|0.57|0.0380
91652399|NCT00368966|183196645|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated||1.3|-1.3|
91788076|NCT00329849|183456644|NON_INFERIORITY_OR_EQUIVALENCE|Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.|Group Ratio|6.37|||||TWO_SIDED|95.0|0.82|49.2|||Risk ratio(MenACWY-CRM/MenACWY-PS)|||||49.2|0.82|
91606930|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6||||0.3266|TWO_SIDED|95.0|-6.61|17.81|||t-test, 2 sided|||Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||17.81|-6.61|0.3266
91606931|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.75||||0.4667|TWO_SIDED|95.0|-16.26|27.76|||t-test, 2 sided|||Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||27.76|-16.26|0.4667
91606932|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91606933|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.5587|TWO_SIDED|95.0|-2.8|1.52|||t-test, 2 sided|||Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.52|-2.80|0.5587
91606934|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.6122|TWO_SIDED|95.0|-1.37|0.81|||t-test, 2 sided|||Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.81|-1.37|0.6122
91606935|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.4642|TWO_SIDED|95.0|-1.87|0.86|||t-test, 2 sided|||Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.86|-1.87|0.4642
91606936|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.2105|TWO_SIDED|95.0|-2.41|0.54|||t-test, 2 sided|||Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.54|-2.41|0.2105
91652400|NCT00368966|183196646|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
91652401|NCT00368966|183196647|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.81||||||95.0|0.7|0.94||||||For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.70|
91791018|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91606937|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.195|TWO_SIDED|95.0|-0.57|2.76|||t-test, 2 sided|||Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||2.76|-0.57|0.1950
91606938|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.5779|TWO_SIDED|95.0|-1.55|2.75|||t-test, 2 sided|||Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.75|-1.55|0.5779
91606939|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.6314|TWO_SIDED|95.0|-2.15|3.5|||t-test, 2 sided|||Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.50|-2.15|0.6314
91606940|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7554|TWO_SIDED|95.0|-2.85|3.87|||t-test, 2 sided|||Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||3.87|-2.85|0.7554
91606941|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.94||||0.3781|TWO_SIDED|95.0|-13.22|5.34|||t-test, 2 sided|||Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||5.34|-13.22|0.3781
91606942|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.85||||0.5715|TWO_SIDED|95.0|-13.83|8.13|||t-test, 2 sided|||Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||8.13|-13.83|0.5715
91788077|NCT02683746|183456688|NON_INFERIORITY|The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.|Mean Difference (Net)|0.06||||0.0002|TWO_SIDED|95.0|-0.13|0.24||P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model|||||0.24|-0.13|0.0002
91788078|NCT02683746|183456696|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14||||||||0.14|-0.83|
91606943|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.58||||0.1271|TWO_SIDED|95.0|-19.08|3.93|||t-test, 2 sided|||Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||3.93|-19.08|0.1271
91606944|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91606945|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.6785|TWO_SIDED|95.0|-1.03|1.58|||t-test, 2 sided|||Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.58|-1.03|0.6785
91606946|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.4623|TWO_SIDED|95.0|-1.63|0.74|||t-test, 2 sided|||Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.74|-1.63|0.4623
91606947|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.9302|TWO_SIDED|95.0|-1.31|1.2|||t-test, 2 sided|||Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.20|-1.31|0.9302
91652402|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
91652403|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|9.28||||||95.0|8.18|10.53||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||10.53|8.18|
91652404|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.15||||||95.0|1.05|1.25||||||For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.25|1.05|
91709817|NCT00237692|183312363|SUPERIORITY_OR_OTHER||% Diff|13.2|||||TWO_SIDED|95.0|2.0|24.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.||24.4|2.0|
91788079|NCT02683746|183456697|OTHER||Mean Difference (Net)|0.03|||<|0.0001|TWO_SIDED|95.0|-0.07|0.13||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.13|-0.07|<0.0001
91606948|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.7502|TWO_SIDED|95.0|-1.84|1.33|||t-test, 2 sided|||Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.33|-1.84|0.7502
91652405|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.61||||||95.0|1.41|1.83||||||For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.83|1.41|
91652406|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.45||||||95.0|1.3|1.61||||||For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.61|1.30|
91652407|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|0.93||||||95.0|0.83|1.03||||||For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.03|0.83|
91606949|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.9335|TWO_SIDED|95.0|-2.12|1.95|||t-test, 2 sided|||Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.95|-2.12|0.9335
91606950|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.9191|TWO_SIDED|95.0|-2.4|2.17|||t-test, 2 sided|||Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.17|-2.40|0.9191
91606951|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.675|TWO_SIDED|95.0|-3.46|2.27|||t-test, 2 sided|||Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||2.27|-3.46|0.6750
91606952|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.5874|TWO_SIDED|95.0|-4.2|2.43|||t-test, 2 sided|||Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.43|-4.20|0.5874
91606953|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27||||0.4507|TWO_SIDED|95.0|-7.53|16.06|||t-test, 2 sided|||Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||16.06|-7.53|0.4507
91606954|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9||||0.3087|TWO_SIDED|95.0|-4.28|12.08|||t-test, 2 sided|||Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||12.08|-4.28|0.3087
91606955|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.9635|TWO_SIDED|95.0|-16.26|15.76|||t-test, 2 sided|||Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||15.76|-16.26|0.9635
91606956|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91606957|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.6699|TWO_SIDED|95.0|-2.37|1.53|||t-test, 2 sided|||Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.53|-2.37|0.6699
91709818|NCT00237692|183312363|SUPERIORITY_OR_OTHER||% Diff|13.5|||||TWO_SIDED|95.0|2.4|24.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.||24.6|2.4|
91709819|NCT00237692|183312363|SUPERIORITY_OR_OTHER||% diff|8.6|||||TWO_SIDED|95.0|-2.9|20.2||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 12 months.||20.2|-2.9|
91652408|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|4.0||||||95.0|3.55|4.5||||||For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||4.50|3.55|
91652409|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.6||||||95.0|1.46|1.76||||||For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.76|1.46|
91652410|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
91652411|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.94||||||95.0|1.78|2.11||||||For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.11|1.78|
91652412|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|2.87||||||95.0|2.58|3.2||||||For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||3.20|2.58|
91652413|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|2.18||||||95.0|1.98|2.41||||||For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.41|1.98|
91652414|NCT00368966|183196650|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|1.18|1.44||||||For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.44|1.18|
91652415|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
91652416|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.9||||||95.0|-6.0|2.0||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||2.0|-6.0|
91652417|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
91652418|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.3|-1.3|
91652419|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.2|2.6||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated||2.6|-5.2|
91652420|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.3|-1.3|
91652421|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.4|3.2||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated||3.2|-4.4|
91652422|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|1.7||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.7|-1.7|
91652423|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.4||||||95.0|-5.1|2.2||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated||2.2|-5.1|
91652424|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.4|-1.4|
91652425|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.4|-1.4|
91652426|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.6|3.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated||3.3|-4.6|
91652427|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.4|-1.4|
91788080|NCT02683746|183456697|OTHER||Mean Difference (Net)|0.07|||<|0.0001|TWO_SIDED|95.0|-0.07|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.20|-0.07|<0.0001
91606958|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0055|TWO_SIDED|95.0|-3.98|-0.7|||t-test, 2 sided|||Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||-0.70|-3.98|0.0055
91652428|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.7||||||95.0|-5.8|2.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated||2.3|-5.8|
91788081|NCT02683746|183456697|OTHER||Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.08|0.24||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.24|-0.08|<0.0001
91788082|NCT02683746|183456697|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.20|-0.16|<0.0001
91606959|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.2793|TWO_SIDED|95.0|-2.92|0.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.85|-2.92|0.2793
91606960|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.2999|TWO_SIDED|95.0|-3.17|0.99|||t-test, 2 sided|||Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.99|-3.17|0.2999
91606961|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.327|TWO_SIDED|95.0|-3.82|1.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.29|-3.82|0.3270
91606962|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9779|TWO_SIDED|95.0|-2.39|2.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.45|-2.39|0.9779
91606963|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.8344|TWO_SIDED|95.0|-4.25|3.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.45|-4.25|0.8344
91606964|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.46||||0.5494|TWO_SIDED|95.0|-3.5|6.41|||t-test, 2 sided|||Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||6.41|-3.50|0.5494
91606965|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.0136|TWO_SIDED|95.0|3.15|22.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||22.85|3.15|0.0136
91606966|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.78||||0.0247|TWO_SIDED|95.0|2.26|25.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||25.29|2.26|0.0247
91652429|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7|||||TWO_SIDED|95.0|-2.5|0.7||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.7|-2.5|
91652430|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
91709820|NCT00237692|183312364|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|61.8|||||TWO_SIDED|95.0|53.0|70.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 18 months||70.6|53.0|
91606967|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.3527|TWO_SIDED|95.0|-12.91|22.91|||t-test, 2 sided|||Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||22.91|-12.91|0.3527
91606968|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91606969|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.76||||0.1309|TWO_SIDED|95.0|-4.05|0.53|||t-test, 2 sided|||Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.||0.53|-4.05|0.1309
91606970|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.051|TWO_SIDED|95.0|-2.72|0.01|||t-test, 2 sided|||Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.72|0.0510
91606971|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.3858|TWO_SIDED|95.0|-2.44|0.95|||t-test, 2 sided|||Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.95|-2.44|0.3858
91606972|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.3943|TWO_SIDED|95.0|-2.9|1.15|||t-test, 2 sided|||Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.15|-2.90|0.3943
91606973|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.3499|TWO_SIDED|95.0|-3.53|1.27|||t-test, 2 sided|||Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.27|-3.53|0.3499
91606974|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9567|TWO_SIDED|95.0|-2.64|2.5|||t-test, 2 sided|||Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.50|-2.64|0.9567
91606975|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.77||||0.2901|TWO_SIDED|95.0|-5.12|1.58|||t-test, 2 sided|||Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.58|-5.12|0.2901
91606976|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.5857|TWO_SIDED|95.0|-5.05|2.92|||t-test, 2 sided|||Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.92|-5.05|0.5857
91606977|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.9635|TWO_SIDED|95.0|-12.56|12.02|||t-test, 2 sided|||Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||12.02|-12.56|0.9635
91606978|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.685|TWO_SIDED|95.0|-15.36|10.56|||t-test, 2 sided|||Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||10.56|-15.36|0.6850
91788083|NCT02683746|183456697|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.15|0.19||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.19|-0.15|<0.0001
91652431|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-2.8|0.8||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.8|-2.8|
91606979|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.75||||0.4968|TWO_SIDED|95.0|-19.23|11.73|||t-test, 2 sided|||Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||11.73|-19.23|0.4968
91606980|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91606981|NCT00609622|183106145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5891|TWO_SIDED|95.0|-2.71|1.55|||t-test, 2 sided|||Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.||1.55|-2.71|0.5891
91606982|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.5081|TWO_SIDED|95.0|-2.5|1.24|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||1.24|-2.50|0.5081
91606983|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.6977|TWO_SIDED|95.0|-2.67|1.79|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.79|-2.67|0.6977
91606984|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76||||0.0797|TWO_SIDED|95.0|-5.85|0.33|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.33|-5.85|0.0797
91606985|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.5808|TWO_SIDED|95.0|-5.62|3.17|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||3.17|-5.62|0.5808
91652432|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.5|
91788084|NCT02683746|183456697|OTHER||Mean Difference (Net)|0.01|||<|0.0001|TWO_SIDED|95.0|-0.17|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.20|-0.17|<0.0001
91788085|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.15|0.65|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.|||0.65|-0.15|
91788086|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.2|0.69|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.|||0.69|-0.20|
91606986|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.7046|TWO_SIDED|95.0|-6.44|4.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||4.38|-6.44|0.7046
91606987|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.18||||0.2052|TWO_SIDED|95.0|-2.4|10.76|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||10.76|-2.40|0.2052
91606988|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.27||||0.0483|TWO_SIDED|95.0|0.07|16.46|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||16.46|0.07|0.0483
91606989|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.93||||0.6832|TWO_SIDED|95.0|-16.41|24.26|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||24.26|-16.41|0.6832
91606990|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.9081|TWO_SIDED|95.0|-18.05|20.05|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||20.05|-18.05|0.9081
91606991|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.7289|TWO_SIDED|95.0|-12.88|16.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||16.38|-12.88|0.7289
91606992|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91606993|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.6921|TWO_SIDED|95.0|-4.43|2.95|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.||2.95|-4.43|0.6921
91606994|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9788|TWO_SIDED|95.0|-0.19|0.19|||t-test, 2 sided|||Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.19|-0.19|0.9788
91606995|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2747|TWO_SIDED|95.0|-0.33|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.09|-0.33|0.2747
91709821|NCT00237692|183312364|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.4|||||TWO_SIDED|95.0|50.8|67.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at 18 months||67.9|50.8|
91709822|NCT00237692|183312364|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.5|||||TWO_SIDED|95.0|55.1|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months.||72.0|55.1|
91709823|NCT00237692|183312364|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|71.6|||||TWO_SIDED|95.0|63.7|79.5|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months||79.5|63.7|
91788087|NCT02683746|183456698|OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.42|0.4|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.|||0.40|-0.42|
91606996|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.2776|TWO_SIDED|95.0|-0.5|0.14|||t-test, 2 sided|||Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.14|-0.50|0.2776
91606997|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.1403|TWO_SIDED|95.0|-0.62|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.09|-0.62|0.1403
91788088|NCT02683746|183456698|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.42|0.36|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.36|-0.42|
91788089|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.19|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.|||0.57|-0.19|
91606998|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9151|TWO_SIDED|95.0|-0.55|0.5|||t-test, 2 sided|||Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||0.50|-0.55|0.9151
91606999|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.3277|TWO_SIDED|95.0|-0.36|1.05|||t-test, 2 sided|||Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.05|-0.36|0.3277
91607000|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.86|0.86|||t-test, 2 sided|||Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||0.86|-0.86|1.0000
91607001|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57||||0.5661|TWO_SIDED|95.0|-1.53|2.67|||t-test, 2 sided|||Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||2.67|-1.53|0.5661
91607002|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7309|TWO_SIDED|95.0|-2.95|2.15|||t-test, 2 sided|||Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||2.15|-2.95|0.7309
91607003|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.25||||0.3273|TWO_SIDED|95.0|-2.16|4.66|||t-test, 2 sided|||Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||4.66|-2.16|0.3273
91607004|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
91607005|NCT00609622|183106146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.7108|TWO_SIDED|95.0|-0.39|0.27|||t-test, 2 sided|||Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.||0.27|-0.39|0.7108
91607006|NCT00666562|183106191|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
91709824|NCT00237692|183312364|SUPERIORITY_OR_OTHER||% Diff|-2.4|||||TWO_SIDED|95.0|-14.6|9.7||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.||9.7|-14.6|
91709825|NCT00237692|183312364|SUPERIORITY_OR_OTHER||% Diff|1.7|||||TWO_SIDED|95.0|-10.3|13.8||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.||13.8|-10.3|
91709826|NCT00237692|183312364|SUPERIORITY_OR_OTHER||% Diff|9.8|||||TWO_SIDED|95.0|-1.9|21.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 18 months.||21.4|-1.9|
91709827|NCT00237692|183312366|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|2.0|||||TWO_SIDED|95.0|-3.1|7.1|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||7.1|-3.1|
91788090|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.26|0.55|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.|||0.55|-0.26|
91788091|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-0.16|0.71|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.|||0.71|-0.16|
91788092|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.22|0.6|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.60|-0.22|
91788093|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.47|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.|||0.47|-0.41|
91788094|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.28|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.|||0.57|-0.28|
91788095|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.34|0.56|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.|||0.56|-0.34|
91788096|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.46|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.46|-0.41|
91788097|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.47|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.|||0.57|-0.47|
91788098|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.41|0.54|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.54|-0.41|
91788099|NCT02683746|183456698|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.47|0.53|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.53|-0.47|
91788100|NCT02683746|183456698|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.14|-0.83|
91788101|NCT04987944|183456702|OTHER||Least square mean difference|-9.8|||||TWO_SIDED|95.0|-24.5|5.0||||||||5.0|-24.5|
91788102|NCT04987944|183456703|OTHER||Least square mean difference|-3.9|||||TWO_SIDED|95.0|-19.4|11.5||||||||11.5|-19.4|
91788103|NCT04987944|183456704|OTHER||Least square mean difference|0.423|||||TWO_SIDED|95.0|-0.125|0.972||||||||0.972|-0.125|
91607007|NCT02811744|183106213|EQUIVALENCE|Equivalence was defined as no significant difference between study groups on a T-test.||||||0.5||||||No adjustments on the comparison. There was no multiple comparison adjustment for the p value, as this was the primary outcome. This is the experimental p value; the threshold for significance was 0.05.|t-test, 2 sided|||No power calculation. This is an exploratory study.||||0.5
91607008|NCT01896232|183106272|NON_INFERIORITY_OR_EQUIVALENCE|Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was \< 12%, the prespecified margin for non-inferiority.|Stratified Treatment Difference|-10.48|||||TWO_SIDED|95.0|-17.45|-3.51||||||"The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region."||-3.51|-17.45|
91607009|NCT01896232|183106273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.001|TWO_SIDED|95.0|1.21|2.23|||Cochran-Mantel-Haenszel||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.23|1.21|0.001
91788104|NCT02614469|183456708|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|98.0|108.0|||||Fed/Fasting Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||108|98.0|
91788105|NCT02614469|183456709|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|99.3|||||TWO_SIDED|90.0|96.9|102.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||102|96.9|
91788106|NCT02614469|183456713|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|90.9|118.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||118|90.9|
91788107|NCT02614469|183456714|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|83.4|||||TWO_SIDED|90.0|62.1|112.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||112|62.1|
91788108|NCT00345332|183456720|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
91607010|NCT01896232|183106274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Cochran-Mantel-Haenszel||The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.17|1.16|0.004
91652433|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-2.1|2.9||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||2.9|-2.1|
91652434|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
91652435|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8|||||TWO_SIDED|95.0|-2.1|3.8||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||3.8|-2.1|
91607011|NCT01896232|183106275|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.15||0.27|TWO_SIDED|95.0|0.89|1.49|||Generalized Linear Mixed Model||The treatment rate ratio is Etelcalcetide : Cinacalcet.|"Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||1.49|0.89|0.27
91607012|NCT01896232|183106276|SUPERIORITY_OR_OTHER||Treatment difference|-3.48|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.76|-2.21|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.||-2.21|-4.76|
91607013|NCT01896232|183106277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.||1.59|0.83|
91607014|NCT01896232|183106278|SUPERIORITY_OR_OTHER||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.18|0.12|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.||0.12|-0.18|
91607015|NCT01896232|183106279|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.86|1.72|||||The treatment rate ratio is Etelcalcetide : Cinacalcet.|This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.||1.72|0.86|
91607016|NCT00686205|183106280|SUPERIORITY_OR_OTHER||Clinical Specificity|99.94||||||95.0|99.88|99.97|||Binomial Exact|Sample size is based on power of 80%, alpha level of 0.05, using the binomial distribution when comparing to a lower bound of specificity at 99.84.||||99.97|99.88|
91652436|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.7|-1.8|
91607017|NCT00686205|183106281|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0||||||95.0|99.76|100.0|||Binomial Exact|||||100.00|99.76|
91607018|NCT03168867|183106282|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
91652437|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||1.3|-1.4|
91788109|NCT00345332|183456721|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
91788110|NCT01976988|183456775|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
91788111|NCT01976988|183456776|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||0.36
91788112|NCT01976988|183456777|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
91788113|NCT01976988|183456778|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1
91788114|NCT01976988|183456779|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91788115|NCT01976988|183456780|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
91788116|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|26.5||||0.321|TWO_SIDED|95.0|-25.9|78.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||78.9|-25.9|0.321
91788117|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|13.1||||0.62|TWO_SIDED|95.0|-38.9|65.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||65.1|-38.9|0.620
91788118|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.0||||0.665|TWO_SIDED|95.0|-55.5|35.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||35.4|-55.5|0.665
91788119|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.6||||0.865|TWO_SIDED|95.0|-57.6|48.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||48.4|-57.6|0.865
91788120|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|31.9||||0.174|TWO_SIDED|95.0|-14.1|77.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||77.9|-14.1|0.174
91788121|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|19.3||||0.472|TWO_SIDED|95.0|-33.4|71.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||71.9|-33.4|0.472
91607019|NCT01021111|183106306|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.||||<0.01
91607020|NCT01021111|183106307|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Pearson|||The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05||||<0.05
91607021|NCT01051739|183106329|SUPERIORITY_OR_OTHER|||||||0.21||||||The a priori threshold of statistical significance is p\<0.05|Kaplan Meyer survival curves|||||||.21
91607022|NCT02469246|183106365|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.|Difference in Percentages|-3.8||||0.15|TWO_SIDED|95.002|-8.9|1.1|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||1.1|-8.9|0.15
91607023|NCT02469246|183106366|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|-6.3||||0.042|TWO_SIDED|95.0|-12.3|-0.3|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||-0.3|-12.3|0.042
91607024|NCT02469246|183106367|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.1||||0.45|TWO_SIDED|95.002|-1.0|3.5|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||3.5|-1.0|0.45
91613721|NCT02078713|183121562|SUPERIORITY||Odds Ratio (OR)|1.06||||0.78|TWO_SIDED|95.0|0.69|1.65||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.65|0.69|0.78
91613722|NCT02078713|183121563|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.35|0.66|0.75
91613723|NCT02078713|183121563|SUPERIORITY||Odds Ratio (OR)|1.07||||0.71|TWO_SIDED|95.0|0.75|1.53||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.53|0.75|0.71
91613724|NCT02078713|183121564|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.34||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.34|0.66|0.75
91613725|NCT02078713|183121564|SUPERIORITY||Odds Ratio (OR)|1.17||||0.37|TWO_SIDED|95.0|0.83|1.64||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.64|0.83|0.37
91613726|NCT02078713|183121565|SUPERIORITY||Odds Ratio (OR)|1.27||||0.63|TWO_SIDED|95.0|0.48|3.37||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||3.37|0.48|0.63
91613727|NCT02078713|183121565|SUPERIORITY||Odds Ratio (OR)|1.83||||0.11|TWO_SIDED|95.0|0.88|3.8||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||3.80|0.88|0.11
91613728|NCT00372190|183121613|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91652438|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.7|||||TWO_SIDED|95.0|-0.6|2.6||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.6|-0.6|
91652439|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.0|2.0||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.0|-1.0|
91652440|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
91652441|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||2.2|-1.1|
91652442|NCT00368966|183196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
91652443|NCT00368966|183196652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.82|1.23||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||1.23|0.82|
91652444|NCT00368966|183196652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.76|1.18||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.18|0.76|
91652445|NCT00368966|183196652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.76|1.19||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.19|0.76|
91652446|NCT00368966|183196652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.69|0.98||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||0.98|0.69|
91652447|NCT00368966|183196652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.9||||||95.0|0.75|1.09||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.09|0.75|
91788122|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|42.4||||0.072|TWO_SIDED|95.0|-3.8|88.7||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||88.7|-3.8|0.072
91788123|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|21.9||||0.234|TWO_SIDED|95.0|-14.2|58.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||58.0|-14.2|0.234
91788124|NCT01328444|183456781|SUPERIORITY_OR_OTHER||Least squares mean difference|32.4||||0.08|TWO_SIDED|95.0|-3.9|68.8||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||68.8|-3.9|0.080
91788125|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087||||0.003|TWO_SIDED|95.0|0.03|0.143||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.143|0.030|0.003
91613729|NCT00623467|183121617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_DEVIATION|0.86|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613730|NCT00623467|183121617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613731|NCT00623467|183121617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|STANDARD_DEVIATION|0.54|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613732|NCT00623467|183121618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.8|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613733|NCT00623467|183121618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.94|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613734|NCT00623467|183121618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|STANDARD_DEVIATION|0.74|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613735|NCT00623467|183121619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_DEVIATION|0.82|<|0.0001||||||for contrast enhancement|paired t-test|||||||<0.0001
91613736|NCT00623467|183121619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613737|NCT00623467|183121619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.57|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613738|NCT00623467|183121620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613739|NCT00623467|183121620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.71|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613740|NCT00623467|183121620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.53|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91607025|NCT02469246|183106368|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.4||||0.34|TWO_SIDED|95.0|-1.0|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-1.0|0.34
91607026|NCT02469246|183106369|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-1.6||||0.62|TWO_SIDED|95.0|-7.4|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-7.4|0.62
91607027|NCT02469246|183106370|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-5.9||||0.069|TWO_SIDED|95.0|-12.2|0.4|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||0.4|-12.2|0.069
91607028|NCT02469246|183106371|SUPERIORITY||Difference in LSM|-32.0||||0.026|TWO_SIDED|95.0|-61.0|-4.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-4|-61|0.026
91607029|NCT02469246|183106372|SUPERIORITY||Difference in LSM|-39.0||||0.013|TWO_SIDED|95.0|-70.0|-8.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-8|-70|0.013
91607030|NCT02469246|183106373|SUPERIORITY||Difference in LSM|0.179||||0.4|TWO_SIDED|95.0|-0.24|0.598||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.598|-0.240|0.40
91607031|NCT02469246|183106374|SUPERIORITY||Difference in LSM|0.165||||0.53|TWO_SIDED|95.0|-0.348|0.678||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.678|-0.348|0.53
91607032|NCT02469246|183106375|SUPERIORITY||Difference in LSM|0.151||||0.63|TWO_SIDED|95.0|-0.465|0.767||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.767|-0.465|0.63
91607033|NCT02469246|183106376|SUPERIORITY||Difference in LSM|-0.056||||0.89|TWO_SIDED|95.0|-0.825|0.713||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.713|-0.825|0.89
91607034|NCT03352245|183106382|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.889|TWO_SIDED||||||Mixed Models Analysis|||||||0.889
91607035|NCT03352245|183106383|SUPERIORITY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
91607036|NCT03352245|183106384|SUPERIORITY||Mean Difference (Net)|7.79|STANDARD_ERROR_OF_MEAN|5.51||0.166|TWO_SIDED||||||Mixed Models Analysis|||||||0.166
91607037|NCT03352245|183106385|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|3.41||0.853|TWO_SIDED||||||Mixed Models Analysis|||||||0.853
91607038|NCT03352245|183106386|SUPERIORITY||Mean Difference (Net)|17.04|STANDARD_ERROR_OF_MEAN|7.16||0.022|TWO_SIDED||||||Mixed Models Analysis|||||||0.022
91607039|NCT03352245|183106387|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|3.83||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
91607040|NCT03352245|183106388|SUPERIORITY||Mean Difference (Net)|-5.18|STANDARD_ERROR_OF_MEAN|6.88||0.456|TWO_SIDED||||||Mixed Models Analysis|||||||0.456
91607041|NCT03352245|183106389|SUPERIORITY||Mean Difference (Net)|-2.05|STANDARD_ERROR_OF_MEAN|3.13||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
91607042|NCT03352245|183106390|SUPERIORITY||Mean Difference (Net)|-8.65|STANDARD_ERROR_OF_MEAN|5.8||0.144|TWO_SIDED||||||Mixed Models Analysis|||||||0.144
91607043|NCT03352245|183106391|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|6.28||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
91607044|NCT03352245|183106392|SUPERIORITY||Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|7.45||0.254|TWO_SIDED||||||Mixed Models Analysis|||||||0.254
91613741|NCT00623467|183121621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|5.31|||||||||||for BR1|||||
91613742|NCT00623467|183121621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|8.77|||||||||||for BR2|||||
91613743|NCT00623467|183121621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|4.2|||||||||||for BR3|||||
91613744|NCT00623467|183121621|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|3.53|||TWO_SIDED|95.0|-0.07|0.704|||95% confidence interval for paired means||confidence interval provided for average reader, lower limit is compared to noninferiority margin|||0.704|-0.070|
91613745|NCT00623467|183121622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|0.68|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
91523503|NCT04270747|182922881|OTHER|A pre-specified similarity margin of (-3, 3) ETDRS letters was used to demonstrate clinical similarity for the mean change from Baseline in BCVA at Week 8.|Difference between means|0.1|||||TWO_SIDED|90.0|-1.1|1.3|||||Estimated using analysis of covariance (ANCOVA) model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||1.3|-1.1|
91788126|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.084|0.196||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.196|0.084|<0.001
91788127|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.05|0.148||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.148|0.050|<0.001
91607045|NCT03352245|183106393|SUPERIORITY||Mean Difference (Net)|-13.31|STANDARD_ERROR_OF_MEAN|6.62||0.051|TWO_SIDED||||||Mixed Models Analysis|||||||0.051
91607046|NCT03352245|183106394|SUPERIORITY||Mean Difference (Net)|4.07|STANDARD_ERROR_OF_MEAN|8.71||0.643|TWO_SIDED||||||Mixed Models Analysis|||||||0.643
91607047|NCT03352245|183106395|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|8.5||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.290
91607048|NCT03352245|183106396|SUPERIORITY||Mean Difference (Net)|9.99|STANDARD_ERROR_OF_MEAN|5.49||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
91607049|NCT03352245|183106397|SUPERIORITY||Mean Difference (Net)|5.27|STANDARD_ERROR_OF_MEAN|4.38||0.237|TWO_SIDED||||||Mixed Models Analysis|||||||0.237
91607050|NCT03352245|183106398|SUPERIORITY||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|6.49||0.861|TWO_SIDED||||||Mixed Models Analysis|||||||0.861
91607051|NCT02690701|183106406|SUPERIORITY|This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.|Least Square Mean|-0.053|STANDARD_ERROR_OF_MEAN|0.059||0.3712|TWO_SIDED|95.0|-0.169|0.064|||ANCOVA|||Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)||0.064|-0.169|0.3712
91607052|NCT02700451|183106436|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||Threshold for statistical significance was p = 0.05|Kruskal-Wallis|||The distribution of OME total in the first 72H is the same across these arms||||<0.001
91607053|NCT02700451|183106436|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||The thresholds for statistical significant was p = 0.05|Kruskal-Wallis|||The distribution of OME total to discharge is the same across these arms||||<0.001
91607054|NCT02700451|183106437|EQUIVALENCE|Two-sided||||||0.048|||||||Chi-squared|||Similar Distribution of opioid use between the 3 arms||||0.048
91607055|NCT02700451|183106438|EQUIVALENCE|Two-sided||||||0.595|||||||Chi-squared|||||||0.595
91607056|NCT02700451|183106441|EQUIVALENCE|Two-sided 95% confidence interval||||||0.732|||||||Kruskal-Wallis|||The distribution of POD1 - Current pain level is the same across the 3 arms||||0.732
91607057|NCT02700451|183106441|EQUIVALENCE|Two-sided 95% confidence interval||||||0.896|||||||Kruskal-Wallis|||The distribution of POD1 - Best pain level is the same across the 3 arms||||0.896
91607058|NCT02700451|183106441|EQUIVALENCE|Two-sided 95% confidence interval||||||0.004|||||||Kruskal-Wallis|||The distribution of POD1 - Worst pain level is the same across the 3 arms||||0.004
91607059|NCT02700451|183106441|EQUIVALENCE|Two-sided 95% confidence interval||||||0.325|||||||Kruskal-Wallis|||The distribution of POD3 - Current pain level is the same across the 3 arms||||0.325
91607060|NCT02700451|183106441|EQUIVALENCE|Two-sided 95% confidence interval||||||0.283|||||||Kruskal-Wallis|||The distribution of POD3 - Best pain level is the same across the 3 arms||||0.283
91607061|NCT02700451|183106441|EQUIVALENCE|Two-sided 95% confidence interval||||||0.61|||||||Kruskal-Wallis|||The distribution of POD3 - Worst pain level is the same across the 3 arms||||0.610
91607062|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 arms||||0.016
91607063|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.294|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms||||0.294
91607064|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.016
91607065|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.082|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms||||0.082
91607066|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.117|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms||||0.117
91607067|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.061|||||||Fisher Exact|||The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms||||0.061
91607068|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.023|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.023
91607069|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.681|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms||||0.681
91607070|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.405|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms||||0.405
91607071|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.458|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.458
91607072|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.482|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms||||0.482
91607073|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.544|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms||||0.544
91607074|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.202|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms||||0.202
91607075|NCT02700451|183106442|EQUIVALENCE|Two-sided 95% confidence interval||||||0.58|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.580
91652448|NCT00368966|183196652|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.88|1.29||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.29|0.88|
91607076|NCT02700451|183106444|EQUIVALENCE|Two-sided 95% confidence interval||||||0.928|||||||Kruskal-Wallis|||The distribution of Total Drain output at 24H is the same across the 3 arms||||0.928
91652449|NCT00368966|183196653|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.75|0.96||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.75|
91652450|NCT00368966|183196653|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.88|1.2||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.88|
91652451|NCT00368966|183196653|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.71|1.02||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.71|
91652452|NCT00368966|183196653|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.12||||||95.0|0.9|1.4||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.40|0.90|
91607077|NCT02700451|183106444|EQUIVALENCE|Two-sided 95% confidence interval||||||0.906|||||||Kruskal-Wallis|||The distribution of Total Drain output at 48H is the same across the 3 arms||||0.906
91607078|NCT02700451|183106444|EQUIVALENCE|Two-sided 95% confidence interval||||||0.926|||||||Kruskal-Wallis|||The distribution of Total Drain output at 72H is the same across the 3 arms||||0.926
91652453|NCT00368966|183196654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.93|1.13||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.93|
91652454|NCT00368966|183196654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.96|1.2||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.96|
91652455|NCT00368966|183196654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.05||||||95.0|0.92|1.18||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.92|
91652456|NCT00368966|183196654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.88|1.14||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.88|
91652457|NCT00368966|183196654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.88|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.88|
91607079|NCT02700451|183106444|EQUIVALENCE|Two-sided 95% confidence interval||||||0.934|||||||Kruskal-Wallis|||The distribution of Total Drain output at Discharge is the same across the 3 arms||||0.934
91607080|NCT02700451|183106445|EQUIVALENCE|Two-sided||||||0.078|||||||Chi-squared|||Proportion of patient receiving at least 1 transfusion is the same across the 3 arms||||0.078
91607081|NCT02700451|183106446|EQUIVALENCE|Two-sided 95% confidence interval||||||792|||||||Chi-squared|||||||0792
91607082|NCT02700451|183106447|EQUIVALENCE|Two-sided 95% confidence interval||||||0.034|||||||Kruskal-Wallis|||The distribution of Length of stay in day is the same across these arms||||0.034
91607083|NCT02700451|183106447|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Kruskal-Wallis|||The distribution of Length of stay in hour is the same across these arms||||0.030
91607084|NCT02700451|183106448|EQUIVALENCE|Two-sided 95% confidence interval||||||0.974|||||||ANOVA|||Comparison of the PCS score between the 3 arms||||0.974
91607085|NCT02700451|183106448|EQUIVALENCE|Two-sided 95% confidence interval||||||0.444|||||||ANOVA|||Comparison of the MCS between the 3 ams||||0.444
91607086|NCT02700451|183106449|EQUIVALENCE|Two-sided 95% confidence interval||||||0.215|||||||ANOVA|||||||0.215
91607087|NCT02700451|183106450|EQUIVALENCE|Two-sided 95% confidence interval||||||0.044|||||||ANOVA|||Comparison PCS score between the 3 arms||||0.044
91788128|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.067|0.181||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.181|0.067|<0.001
91788129|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.062|0.161||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.161|0.062|<0.001
91788130|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.32|TWO_SIDED|95.0|-0.028|0.086||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.086|-0.028|0.320
91788131|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.07||||0.007|TWO_SIDED|95.0|0.019|0.12||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.120|0.019|0.007
91607088|NCT02700451|183106450|EQUIVALENCE|Two-sided 95% confidence interval||||||0.767|||||||ANOVA|||Comparison MCS score between the 3 arms||||0.767
91607089|NCT02700451|183106451|EQUIVALENCE|Two-sided 95% confidence interval||||||0.191|||||||ANOVA|||||||0.191
91607090|NCT02930174|183106467|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.26|TWO_SIDED||||||ANOVA|||||||0.26
91607091|NCT02930174|183106468|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.342|TWO_SIDED||||||ANOVA|||||||0.342
91607092|NCT02930174|183106469|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.184|TWO_SIDED||||||ANOVA|||||||0.184
91613746|NCT00623467|183121622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.65|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613747|NCT00623467|183121623|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|1.6||||95.0|0.03|0.381|||||lower limit of the confidence interval is compared to the noninferiority margin|||0.381|0.030|
91613748|NCT00623467|183121624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|1.47|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613749|NCT00623467|183121624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_DEVIATION|1.34|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613750|NCT00623467|183121624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|1.03|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613751|NCT00623467|183121625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|1.38|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613752|NCT00623467|183121625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_DEVIATION|1.6|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613753|NCT00623467|183121625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|1.25|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613754|NCT00623467|183121626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.39|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613755|NCT00623467|183121626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|1.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613756|NCT00623467|183121626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_DEVIATION|1.02|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613757|NCT00623467|183121627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|1.32|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613758|NCT00623467|183121627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613759|NCT00623467|183121627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.99|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613760|NCT00623467|183121628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|0.48|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613761|NCT00623467|183121628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||<0.0001
91613762|NCT00623467|183121628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613763|NCT00623467|183121629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|STANDARD_DEVIATION|0.4|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613764|NCT00623467|183121629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_DEVIATION|0.38|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613765|NCT00623467|183121629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.34|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613766|NCT00623467|183121630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_DEVIATION|0.37|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613767|NCT00623467|183121630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_DEVIATION|0.45|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613768|NCT00623467|183121630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.3|<|0.0001||||||for internal morphology|paired t test|||||||<0.0001
91607093|NCT02930174|183106470|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.283|TWO_SIDED||||||ANOVA|||||||0.283
91607094|NCT02930174|183106471|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.204|TWO_SIDED||||||ANOVA|||||||0.204
91613769|NCT00623467|183121631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.32|STANDARD_DEVIATION|0.34|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
91613770|NCT00623467|183121631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_DEVIATION|0.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
91613771|NCT00623467|183121631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613772|NCT00623467|183121633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|1.0|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
91613773|NCT00623467|183121633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.9|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613774|NCT00623467|183121634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_DEVIATION|0.63|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
91613775|NCT00623467|183121634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.64|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
91613776|NCT00623467|183121635|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.4||||0.0002|||||||McNemar|||||||0.0002
91613777|NCT00623467|183121636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.0001|||||||McNemar|||||||0.0001
91613778|NCT00623467|183121637|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0285|||||||McNemar|||||||0.0285
91613779|NCT00623467|183121638|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5||||0.0004|||||||McNemar|||||||0.0004
91613780|NCT00623467|183121639|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.5||||0.0588|||||||McNemar|||||||0.0588
91613781|NCT00623467|183121640|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0093|||||||McNemar|||||||0.0093
91613782|NCT00623467|183121641|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.6||||0.0003|||||||McNemar|||||||0.0003
91613783|NCT00623467|183121642|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|||||||McNemar|||||||1.0000
91613784|NCT00623467|183121643|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.8||||0.0016|||||||McNemar|||||||0.0016
91613785|NCT00623467|183121644|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.9||||0.0253|||||||McNemar|||||||0.0253
91613786|NCT00623467|183121645|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.5||||0.0253|||||||McNemar|||||||0.0253
91613787|NCT00623467|183121646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.7|<|0.0001|||||||paired t-test|||||||< 0.0001
91613788|NCT00623467|183121647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.81|<|0.0001|||||||paired t-test|||||||< 0.0001
91613789|NCT03691623|183121659|SUPERIORITY||LS Mean Difference|-588.08|||<|0.001|TWO_SIDED|95.0|-719.8|-456.35|||ANCOVA|||||-456.35|-719.8|< 0.001
91613790|NCT03691623|183121659|SUPERIORITY||LS Mean Difference|-564.63|||<|0.001|TWO_SIDED|95.0|-689.23|-440.02|||ANCOVA|||||-440.02|-689.23|< 0.001
91613791|NCT03691623|183121659|SUPERIORITY||LS Mean Difference|-716.08|||<|0.001|TWO_SIDED|95.0|-879.92|-552.24|||ANCOVA|||||-552.24|-879.92|< 0.001
91613792|NCT03691623|183121659|SUPERIORITY||LS Mean Difference|-736.23|||<|0.001|TWO_SIDED|95.0|-916.36|-556.11|||ANCOVA|||||-556.11|-916.36|< 0.001
91613793|NCT03691623|183121660|SUPERIORITY||LS Mean Difference|-355.91|||<|0.001|TWO_SIDED|95.0|-506.12|-205.69|||ANCOVA|||||-205.69|-506.12|< 0.001
91613794|NCT03691623|183121660|SUPERIORITY||LS Mean Difference|-326.64|||<|0.001|TWO_SIDED|95.0|-469.68|-183.6|||ANCOVA|||||-183.6|-469.68|< 0.001
91613795|NCT03691623|183121660|SUPERIORITY||LS Mean Difference|-313.98|||=|0.001|TWO_SIDED|95.0|-494.27|-133.69|||ANCOVA|||||-133.69|-494.27|= 0.001
91613796|NCT03691623|183121660|SUPERIORITY||LS Mean Difference|-312.73|||=|0.003|TWO_SIDED|95.0|-508.05|-117.4|||ANCOVA|||||-117.4|-508.05|= 0.003
91613797|NCT03691623|183121661|SUPERIORITY||LS Mean Difference|-3.7|||<|0.001|TWO_SIDED|95.0|-5.3|-2.0|||ANCOVA|||||-2|-5.3|< 0.001
91613798|NCT03691623|183121661|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-5.5|-2.4|||ANCOVA|||||-2.4|-5.5|< 0.001
91613799|NCT03691623|183121661|SUPERIORITY||LS Mean Difference|-3.0|||=|0.002|TWO_SIDED|95.0|-4.9|-1.2|||ANCOVA|||||-1.2|-4.9|= 0.002
91613800|NCT03691623|183121661|SUPERIORITY||LS Mean Difference|-2.9|||=|0.006|TWO_SIDED|95.0|-4.9|-0.9|||ANCOVA|||||-0.9|-4.9|= 0.006
91613801|NCT03691623|183121663|SUPERIORITY||LS Mean Difference|-0.82|||=|0.199|TWO_SIDED|95.0|-2.09|0.44|||ANCOVA|||||0.44|-2.09|= 0.199
91613802|NCT03691623|183121663|SUPERIORITY||LS Mean Difference|0.22|||=|0.714|TWO_SIDED|95.0|-0.98|1.43|||ANCOVA|||||1.43|-0.98|= 0.714
91613803|NCT03691623|183121663|SUPERIORITY||LS Mean Difference|-0.19|||=|0.844|TWO_SIDED|95.0|-2.15|1.77|||ANCOVA|||||1.77|-2.15|= 0.844
91613804|NCT03691623|183121663|SUPERIORITY||LS Mean Difference|-1.34|||=|0.21|TWO_SIDED|95.0|-3.46|0.79|||ANCOVA|||||0.79|-3.46|= 0.21
91613805|NCT03691623|183121664|SUPERIORITY||LS Mean Difference|-1.01|||=|0.145|TWO_SIDED|95.0|-2.37|0.36|||ANCOVA|||||0.36|-2.37|= 0.145
91613806|NCT03691623|183121664|SUPERIORITY||LS Mean Difference|-0.65|||=|0.352|TWO_SIDED|95.0|-2.03|0.73|||ANCOVA|||||0.73|-2.03|= 0.352
91613807|NCT03691623|183121664|SUPERIORITY||LS Mean Difference|-2.85|||=|0.002|TWO_SIDED|95.0|-4.55|-1.15|||ANCOVA|||||-1.15|-4.55|= 0.002
91613808|NCT03691623|183121664|SUPERIORITY||LS Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.19|-1.61|||ANCOVA|||||-1.61|-5.19|< 0.001
91652458|NCT00368966|183196654|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.78|1.02||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.78|
91652459|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|0.1|4.4||||||For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||4.4|0.1|
91652460|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|41.2||||||95.0|34.9|46.9||||||For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||46.9|34.9|
91652461|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|7.3||||||95.0|4.1|10.4||||||For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||10.4|4.1|
91652462|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-3.4|1.2||||||For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||1.2|-3.4|
91652463|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|6.4||||||95.0|3.1|9.5||||||For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||9.5|3.1|
91652464|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
91652465|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|26.5||||||95.0|20.7|31.9||||||For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||31.9|20.7|
91709828|NCT00237692|183312366|SUPERIORITY_OR_OTHER||Est. Dif in Patient w/Controlled DBP|0.5|||||TWO_SIDED|95.0|-2.7|3.8|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||3.8|-2.7|
91652466|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|0.8|5.1||||||For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||5.1|0.8|
91652467|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-1.8|6.3||||||For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||6.3|-1.8|
91652468|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|10.0||||||95.0|5.9|13.9||||||For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||13.9|5.9|
91652469|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|13.0||||||95.0|8.6|17.2||||||For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||17.2|8.6|
91652470|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.1|3.1||||||For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.1|-0.1|
91652471|NCT00368966|183196655|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
91652472|NCT01602614|183196661|OTHER|Spearman Rank Correlation||||||0.3117|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.3117
91652473|NCT01602614|183196662|OTHER|Spearman Rank Correlation||||||0.6175||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.6175
91652474|NCT01602614|183196663|OTHER|Spearman Rank Correlation||||||0.7129||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.7129
91652475|NCT01602614|183196664|OTHER|Spearman Rank Correlation||||||0.9828|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9828
91652476|NCT01602614|183196665|OTHER|Spearman Rank Correlation||||||0.9656|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9656
91652477|NCT01602614|183196666|OTHER|Spearman Rank Correlation||||||0.5113|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5113
91788132|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.211|||<|0.001|TWO_SIDED|95.0|0.172|0.249||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.249|0.172|<0.001
91788133|NCT01328444|183456782|SUPERIORITY_OR_OTHER||Least squares mean difference|0.169|||<|0.001|TWO_SIDED|95.0|0.129|0.209||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.209|0.129|<0.001
91788134|NCT03207438|183456787|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
91788135|NCT03207438|183456787|SUPERIORITY||Hazard Ratio (HR)|1.15|STANDARD_ERROR_OF_MEAN|0.1||0.18|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.18
91788136|NCT03207438|183456787|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
91607095|NCT02930174|183106472|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.136|TWO_SIDED||||||ANOVA|||||||0.136
91607096|NCT04325503|183106510|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.0905||||0.015|TWO_SIDED|95.0|0.022|0.159||A priori threshold statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 9||||0.159|0.022|0.015
91607097|NCT04325503|183106511|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.333||||0.694|TWO_SIDED|95.0|-1.55|2.216||A priori threshold for statistical significance is p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||2.216|-1.550|0.694
91607098|NCT04325503|183106512|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|1.444||||0.103|TWO_SIDED|95.0|-0.363|3.252||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||3.252|-0.363|0.103
91607099|NCT04325503|183106513|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-2.09||||0.321|TWO_SIDED|95.0|-6.554|2.372||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 10||||2.372|-6.554|0.321
91607100|NCT04325503|183106514|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.185||||0.265|TWO_SIDED|95.0|-0.175|0.544|||t-test, 2 sided|Paired samples t-test, df = 7||||0.544|-0.175|0.265
91607101|NCT04325503|183106515|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|8.143||||0.027|TWO_SIDED|95.0|1.296|15.0||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 6||||15.0|1.296|0.0270
91607102|NCT04325503|183106516|OTHER|A comparison is not being made between two different treatment groups.||||||0.153||||||A priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.153
91652478|NCT01602614|183196667|OTHER|Spearman Rank Correlation||||||0.217||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.2170
91652479|NCT01602614|183196668|OTHER|Spearman Rank Correlation||||||0.4299||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.4299
91652480|NCT01602614|183196669|OTHER|Spearman Rank Correlation||||||0.8629||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.8629
91652481|NCT01602614|183196670|OTHER|Spearman Rank Correlation||||||0.5717||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5717
91652482|NCT01694485|183196686|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.35||||0.021|TWO_SIDED|90.0|1.41|7.95|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.95|1.41|0.021
91652483|NCT01694485|183196686|SUPERIORITY||Difference in Adjusted Remission Rates|9.0|||||TWO_SIDED|90.0|1.6|14.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.6|1.6|
91652484|NCT01694485|183196686|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.33||||0.03|TWO_SIDED|90.0|1.34|8.26|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.26|1.34|0.030
91652485|NCT01694485|183196686|SUPERIORITY||Difference in Adjusted Remission Rates|8.9|||||TWO_SIDED|90.0|0.8|14.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.9|0.8|
91607103|NCT01642212|183106521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91607104|NCT01642212|183106522|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.75||||0.0096|TWO_SIDED|95.0|-11.808|-1.687||LS mean estimates were determined using an ANCOVA model including treatment group as a factor and the baseline score as a covariate.|ANCOVA|||||-1.687|-11.808|0.0096
91607105|NCT01642212|183106523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.49||||0.2649|TWO_SIDED|95.0|-6.895|1.92||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.920|-6.895|0.2649
91607106|NCT01642212|183106523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.91||||0.2878|TWO_SIDED|95.0|-8.322|2.501||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||2.501|-8.322|0.2878
91523504|NCT04270747|182922882|OTHER||Risk Difference (RD)|-2.1|||||TWO_SIDED|90.0|-5.2|2.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.2|-5.2|
91523505|NCT04270747|182922882|OTHER||Risk Difference (RD)|-1.7|||||TWO_SIDED|90.0|-6.2|2.8|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.8|-6.2|
91607107|NCT01642212|183106525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 15 Eosinophils/HPF||||0.0001
91607108|NCT01642212|183106525|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 1 Eosinophils/HPF||||<0.0001
91607109|NCT01642212|183106526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ score reduction||||0.0206
91607110|NCT01642212|183106526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0275|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ score reduction||||0.0275
91607111|NCT01642212|183106527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 30% DSQ score reduction||||0.0026
91607112|NCT01642212|183106527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 50% DSQ score reduction||||0.0199
91607113|NCT01642212|183106528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-22.34|||<|0.0001|TWO_SIDED|95.0|-30.345|-14.334|||ANCOVA|LS mean based on the ANCOVA model including treatment group as a factor and baseline as a covariate.||||-14.334|-30.345|<0.0001
91607114|NCT01642212|183106529|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.172|-2.358||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-2.358|-5.172|<0.0001
91607115|NCT01642212|183106530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-35.5||||0.0002|TWO_SIDED|95.0|-53.438|-17.57||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of proximal eosinophil count||-17.570|-53.438|0.0002
91607116|NCT01642212|183106530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-59.56|||<|0.0001|TWO_SIDED|95.0|-84.173|-34.948||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of mid- eosinophil count||-34.948|-84.173|<0.0001
91607117|NCT01642212|183106530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-67.38|||<|0.0001|TWO_SIDED|95.0|-93.573|-41.18||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of distal eosinophil count||-41.180|-93.573|<0.0001
91607118|NCT01642212|183106531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.44||||0.0015|TWO_SIDED|95.0|-29.593|-7.293||LS mean estimates were based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-7.293|-29.593|0.0015
91607119|NCT01642212|183106532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|TWO_SIDED|||||P-value for comparison of the treatment difference was determined by Cochran-Mantel-Haenszel row mean score test.|Cochran-Mantel-Haenszel|||Analysis of distribution of scores across all responses||||0.1170
91607120|NCT01642212|183106533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1947|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of heartburn||||0.1947
91613809|NCT03691623|183121665|SUPERIORITY||LS Mean Difference|-24.081|||<|0.001|TWO_SIDED|95.0|-36.554|-11.607|||ANCOVA|||||-11.607|-36.554|< 0.001
91613810|NCT03691623|183121665|SUPERIORITY||LS Mean Difference|-25.954|||<|0.001|TWO_SIDED|95.0|-37.695|-14.213|||ANCOVA|||||-14.213|-37.695|< 0.001
91613811|NCT03691623|183121665|SUPERIORITY||LS Mean Difference|-18.13|||<|0.001|TWO_SIDED|95.0|-27.176|-9.083|||ANCOVA|||||-9.083|-27.176|< 0.001
91613812|NCT03691623|183121665|SUPERIORITY||LS Mean Difference|-19.329|||<|0.001|TWO_SIDED|95.0|-29.106|-9.552|||ANCOVA|||||-9.552|-29.106|< 0.001
91613813|NCT03691623|183121666|SUPERIORITY||LS Mean Difference|-2.1292|||<|0.001|TWO_SIDED|95.0|-2.8491|-1.4093|||ANCOVA|||||-1.4093|-2.8491|< 0.001
91607121|NCT01642212|183106533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8029|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of chest pain||||0.8029
91607122|NCT01642212|183106533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4963|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of regurgitation||||0.4963
91607123|NCT01642212|183106533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5257|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of abdominal pain||||0.5257
91607124|NCT01642212|183106533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of nausea||||0.5219
91607125|NCT01642212|183106533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2886|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of vomiting||||0.2886
91607126|NCT01642212|183106536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. Both responses (no change, worsened) were analyzed collectively.|Cochran-Mantel-Haenszel|||Analysis of symptoms of participants with no symptoms at baseline||||0.1600
91607127|NCT01642212|183106538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ+pain score reduction||||0.0606
91607128|NCT01642212|183106538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ+pain score reduction||||0.0165
91607129|NCT01642212|183106539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7817|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7817
91607130|NCT01642212|183106540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.1686|TWO_SIDED|95.0|-0.222|0.04||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||0.040|-0.222|0.1686
91607131|NCT01642212|183106540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03||||0.8046|TWO_SIDED|95.0|-0.269|0.21||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.210|-0.269|0.8046
91607132|NCT01642212|183106540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.9239|TWO_SIDED|95.0|-0.199|0.219||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.219|-0.199|0.9239
91607133|NCT01642212|183106541|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.4835|TWO_SIDED|95.0|-2.806|1.339||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.339|-2.806|0.4835
91607134|NCT01642212|183106541|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92||||0.0662|TWO_SIDED|95.0|-3.974|0.132||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.132|-3.974|0.0662
91607135|NCT01642212|183106541|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8||||0.1091|TWO_SIDED|95.0|-4.006|0.41||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.410|-4.006|0.1091
91652486|NCT01694485|183196686|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.64||||0.64|TWO_SIDED|90.0|0.13|3.17|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.17|0.13|0.64
91652487|NCT01694485|183196686|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.6|||||TWO_SIDED|90.0|-5.2|5.5||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.5|-5.2|
91607136|NCT00702143|183106550|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0002
91607137|NCT00702143|183106550|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||<0.0001
91607138|NCT00702143|183106550|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0014
91607139|NCT00702143|183106552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||<0.0001
91709829|NCT00237692|183312366|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|0.4|||||TWO_SIDED|95.0|-4.8|5.5|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.||5.5|-4.8|
91709830|NCT00237692|183312366|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|0.7|||||TWO_SIDED|95.0|-2.6|4.0|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management||4.0|-2.6|
91788137|NCT03207438|183456787|SUPERIORITY||Hazard Ratio (HR)|1.17|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.14
91652488|NCT01694485|183196686|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.34||||0.49|TWO_SIDED|90.0|0.03|4.33|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.33|0.03|0.49
91652489|NCT01694485|183196686|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-2.9|||||TWO_SIDED|90.0|-5.5|5.4||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.4|-5.5|
91652490|NCT01694485|183196687|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.78|||<|0.001|TWO_SIDED|90.0|1.71|4.52|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.52|1.71|<0.001
91652491|NCT01694485|183196687|SUPERIORITY||Difference in Adjusted Response Rates|23.4|||||TWO_SIDED|90.0|11.8|33.2||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||33.2|11.8|
91652492|NCT01694485|183196687|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|90.0|1.53|4.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.31|1.53|0.003
91652493|NCT01694485|183196687|SUPERIORITY||Difference in Adjusted Response Rates|21.4|||||TWO_SIDED|90.0|9.0|31.8||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.8|9.0|
91709831|NCT00237692|183312366|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|1.6|||||TWO_SIDED|95.0|-3.3|6.6|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|-3.3|
91788138|NCT03207438|183456788|SUPERIORITY||Hazard Ratio (HR)|1.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
91788139|NCT03207438|183456788|SUPERIORITY||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.17
91788140|NCT03207438|183456788|SUPERIORITY||Hazard Ratio (HR)|1.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
91607140|NCT00702143|183106552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
91607141|NCT00702143|183106552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
91607142|NCT00702143|183106552|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0003
91607143|NCT03871491|183106554|SUPERIORITY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.79||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery||0.79|0.56|<0.001
91607144|NCT03871491|183106555|SUPERIORITY||Risk Ratio (RR)|1.02||||0.56|TWO_SIDED|95.0|0.95|1.09||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group||1.09|0.95|0.56
91607145|NCT03871491|183106556|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.55|0.77||||||||0.77|0.55|
91607146|NCT03871491|183106557|SUPERIORITY||Risk Ratio (RR)|4.04|||||TWO_SIDED|95.0|0.45|36.14||||||||36.14|0.45|
91607147|NCT03871491|183106559|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.55|0.79||||||||0.79|0.55|
91607148|NCT03871491|183106560|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.43|0.75||||||||0.75|0.43|
91607149|NCT03871491|183106561|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||||0.99|0.65|
91652494|NCT01694485|183196687|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|2.54||||0.024|TWO_SIDED|90.0|1.29|5.02|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.02|1.29|0.024
91652495|NCT01694485|183196687|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|21.2|||||TWO_SIDED|90.0|4.9|34.1||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||34.1|4.9|
91788141|NCT03207438|183456788|SUPERIORITY||Hazard Ratio (HR)|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.13|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.13
91788142|NCT03207438|183456789|SUPERIORITY|||||||0.33|||||||Fisher's exact test|||Day 4 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|An exact OR could not be estimated by R; the 95% confidence interval was 0.31 to infinity, p = .33.|||.33
91607150|NCT03871491|183106562|SUPERIORITY||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.56|0.85||||||||0.85|0.56|
91607151|NCT03871491|183106563|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.95|1.01||||||||1.01|0.95|
91607152|NCT03871491|183106565|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||||0.82|0.52|
91607153|NCT03871491|183106566|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15||||||||1.15|0.70|
91607154|NCT03871491|183106567|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.73|0.84||||||||0.84|0.73|
91607155|NCT03871491|183106568|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41||||||||1.41|0.84|
91607156|NCT03871491|183106569|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.96|1.1||||||||1.1|0.96|
91607157|NCT03871491|183106570|SUPERIORITY||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.73|1.47||||||||1.47|0.73|
91607158|NCT03871491|183106571|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.88|1.07||||||||1.07|0.88|
91607159|NCT03871491|183106573|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||||1.21|0.96|
91607160|NCT03871491|183106574|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.94|1.12||||||||1.12|0.94|
91607161|NCT03871491|183106575|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.93|1.0||||||||1.0|0.93|
91607162|NCT03871491|183106576|SUPERIORITY||Risk Ratio (RR)|2.68|||||TWO_SIDED|95.0|0.71|10.1||||||||10.1|0.71|
91607163|NCT04996797|183106577|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|11.8|36.5|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||36.5|11.8|<.0001
91607164|NCT04996797|183106580|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||43.2|17.4|<0.0001
91607165|NCT04996797|183106581|SUPERIORITY||Risk Difference (RD)|43.8|||<|0.0001|TWO_SIDED|95.0|27.4|56.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||56.9|27.4|<.0001
91607166|NCT04996797|183106582|SUPERIORITY||Risk Difference (RD)|20.8||||0.0224||95.0|2.1|37.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factor of biologic status.|95% CI is estimated using Newcombe method for risk difference.|||37.9|2.1|0.0224
91788143|NCT03207438|183456789|SUPERIORITY||Odds Ratio (OR)|1.3||||0.44|TWO_SIDED||||||Fisher's exact test||The exact limits of 95% confidence interval could not be estimated, it was reported as 0.40 to infinity.|Week 1 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup||||.44
91788144|NCT03207438|183456789|SUPERIORITY||Chi-squared|0.38||||0.73|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.73
91607167|NCT04996797|183106583|SUPERIORITY||Risk Difference (RD)|13.1||||0.0223||95.0|1.8|24.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||24.6|1.8|0.0223
91607168|NCT04996797|183106584|SUPERIORITY||Risk Difference (RD)|28.6||||0.0009||95.0|12.1|42.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||42.9|12.1|0.0009
91607169|NCT04996797|183106585|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001||95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
91607170|NCT04996797|183106586|SUPERIORITY||Risk Difference (RD)|17.9||||||95.0|-2.4|36.4|||||95% CI is estimated using Newcombe method for risk difference.|||36.4|-2.4|
91607171|NCT04996797|183106587|SUPERIORITY||Risk Difference (RD)|22.8||||||95.0|0.4|42.2|||||95% CI is estimated using Newcombe method for risk difference.|||42.2|0.4|
91607172|NCT04996797|183106588|SUPERIORITY||Risk Difference (RD)|10.2||||||95.0|-6.9|26.9|||||95% CI is estimated using Newcombe method for risk difference.|||26.9|-6.9|
91607173|NCT04996797|183106589|SUPERIORITY||Risk Difference (RD)|28.9||||||95.0|5.0|48.3|||||95% CI is estimated using Newcombe method for risk difference.|||48.3|5.0|
91607174|NCT04996797|183106590|SUPERIORITY||Risk Difference (RD)|22.2|||||TWO_SIDED|95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
91607175|NCT04996797|183106591|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001|TWO_SIDED|95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
91607176|NCT04996797|183106592|SUPERIORITY||Risk Difference (RD)|22.2||||||95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
91607177|NCT04996797|183106593|SUPERIORITY||Risk Difference (RD)|33.1|||<|0.0001||95.0|17.2|46.8|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||46.8|17.2|<0.0001
91607178|NCT04996797|183106594|SUPERIORITY||Risk Difference (RD)|19.6||||||95.0|-1.7|38.7|||||95% CI is estimated using Newcombe method for risk difference.|||38.7|-1.7|
91607179|NCT05087030|183106648|NON_INFERIORITY|The analysis was performed with an ANCOVA model with %CfB in lumbar spine BMD at Week 52 as the dependent variable, covariates were treatment arm (RGB-14-P and US-licensed Prolia).|Estimated Difference|0.18|||||TWO_SIDED|90.0|-0.465|0.826|||ANCOVA|||||0.826|-0.465|
91607180|NCT05087030|183106648|SUPERIORITY|Non-Superiority Test|Estimated Difference|0.55|||||TWO_SIDED|90.0|-0.099|1.191|||ANCOVA|||||1.191|-0.099|
91607181|NCT05087030|183106649|OTHER||Geometric mean ratio|1.01||||0.494|TWO_SIDED|95.0|0.978|1.046|||ANCOVA|||Comparison between Study Treatment Groups||1.046|0.978|0.494
91607182|NCT05087030|183106650|OTHER||Estimated difference|-0.31||||0.199|TWO_SIDED|95.0|-0.792|0.165|||Mixed model repeated measures|||at Week 26||0.165|-0.792|0.199
91607183|NCT05087030|183106650|OTHER||Estimated difference|-0.16||||0.543|TWO_SIDED|95.0|-0.68|0.358|||mixed model repeated measures|||At Week 52||0.358|-0.680|0.543
91607184|NCT05087030|183106651|OTHER||Estimated Difference|0.03||||0.929|TWO_SIDED|95.0|-0.703|0.769|||mixed model for repeated measures|||Week 26||0.769|-0.703|0.929
91607185|NCT01929083|183106710|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.04
91607186|NCT01929083|183106711|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.003
91607187|NCT01929083|183106712|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||P value for incidence of fatigue/malaise|Fisher Exact|||||||0.04
91607188|NCT01929083|183106712|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||p values for incidence of headache|Fisher Exact|||||||0.60
91607189|NCT01929083|183106712|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of mood changes|Fisher Exact|||||||0.23
91607190|NCT01929083|183106712|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of breast tenderness|Fisher Exact|||||||0.23
91607191|NCT01929083|183106712|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of hypotension|Fisher Exact|||||||0.48
91607192|NCT01929083|183106712|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of vertigo requiring discontinuation of therapy|Fisher Exact|||||||0.48
91607193|NCT01929083|183106713|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
91607194|NCT01929083|183106714|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.002
91607195|NCT01929083|183106715|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||p value for bradycardia|Fisher Exact|||||||0.65
91607196|NCT01929083|183106715|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for burning at infusion site|Fisher Exact|||||||>0.99
91607197|NCT01929083|183106715|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for transient QTc interval \> 500 ms|Fisher Exact|||||||> 0.99
91607198|NCT01929083|183106716|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.43
91607199|NCT01929083|183106717|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.36
91607200|NCT01929083|183106718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.0001
91607201|NCT01929083|183106719|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.0001
91607202|NCT00087438|183106753|SUPERIORITY_OR_OTHER|||||||0.013||||||Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.|z-test, one-sided|||Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.||||0.013
91607203|NCT00283387|183106760|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
91652496|NCT01694485|183196687|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.4||||0.18|TWO_SIDED|90.0|0.13|1.22|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.22|0.13|0.18
91652497|NCT01694485|183196687|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|-13.7|||||TWO_SIDED|90.0|-24.4|2.7||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.7|-24.4|
91607204|NCT03068715|183106779|SUPERIORITY|We assessed the superiority of active over sham.|||||<|0.001|||||||Mixed Models Analysis|||MADRS scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||<0.001
91607205|NCT03068715|183106780|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
91607206|NCT03068715|183106783|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
91607207|NCT03068715|183106784|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.308|||||||t-test, 2 sided|Paired-t test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.308
91607208|NCT03068715|183106784|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.778|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.778
91607209|NCT03068715|183106784|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.468|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.468
91607210|NCT03068715|183106784|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.486|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.486
91607211|NCT03068715|183106785|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.447|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.447
91709832|NCT00237692|183312366|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|3.4|||||TWO_SIDED|95.0|0.3|6.6|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|0.3|
91709833|NCT00685360|183312367|SUPERIORITY||Risk Ratio Mean|1.534|||=|0.0083|TWO_SIDED|95.0|1.107|2.124|||Cochran-Mantel-Haenszel|P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata (cavitation).||||2.124|1.107|=0.0083
91607212|NCT03068715|183106785|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.115|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.115
91613814|NCT03691623|183121666|SUPERIORITY||LS Mean Difference|-2.1129|||<|0.001|TWO_SIDED|95.0|-2.7938|-1.4319|||ANCOVA|||||-1.4319|-2.7938|< 0.001
91613815|NCT03691623|183121666|SUPERIORITY||LS Mean Difference|-3.2191|||<|0.001|TWO_SIDED|95.0|-4.1915|-2.2467|||ANCOVA|||||-2.2467|-4.1915|< 0.001
91613816|NCT03691623|183121666|SUPERIORITY||LS Mean Difference|-2.7831|||<|0.001|TWO_SIDED|95.0|-3.8522|-1.714|||ANCOVA|||||-1.714|-3.8522|< 0.001
91613817|NCT03691623|183121667|SUPERIORITY||LS Mean Difference|-2.01|||<|0.001|TWO_SIDED|95.0|-2.67|-1.35|||ANCOVA|||||-1.35|-2.67|< 0.001
91613818|NCT03691623|183121667|SUPERIORITY||LS Mean Difference|-1.78|||<|0.001|TWO_SIDED|95.0|-2.4|-1.16|||ANCOVA|||||-1.16|-2.4|< 0.001
91613819|NCT03691623|183121667|SUPERIORITY||LS Mean Difference|-1.98|||=|0.009|TWO_SIDED|95.0|-3.43|-0.54|||ANCOVA|||||-0.54|-3.43|= 0.009
91613820|NCT03691623|183121667|SUPERIORITY||LS Mean Difference|-2.41|||=|0.004|TWO_SIDED|95.0|-4.0|-0.82|||ANCOVA|||||-0.82|-4|= 0.004
91613821|NCT03691623|183121668|SUPERIORITY||LS Mean Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.04|-1.17|||ANCOVA|||||-1.17|-3.04|< 0.001
91613822|NCT03691623|183121668|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.89|-1.11|||ANCOVA|||||-1.11|-2.89|< 0.001
91613823|NCT03691623|183121668|SUPERIORITY||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.06|-0.89|||ANCOVA|||||-0.89|-3.06|< 0.001
91613824|NCT03691623|183121668|SUPERIORITY||LS Mean Difference|-2.46|||<|0.001|TWO_SIDED|95.0|-3.64|-1.29|||ANCOVA|||||-1.29|-3.64|< 0.001
91613825|NCT03691623|183121669|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
91613826|NCT03691623|183121669|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
91613827|NCT03691623|183121669|SUPERIORITY||||||=|0.001|||||||Log Rank|||||||= 0.001
91613828|NCT03691623|183121669|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
91613829|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0126|TWO_SIDED|95.0|0.833|0.978|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.833|0.0126
91613830|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.966||||0.0042|TWO_SIDED|95.0|0.944|0.989|||Regression, Logistic|||The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.944|0.0042
91613831|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.656|0.816|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.816|0.656|<0.0001
91613832|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686|||<|0.0001|TWO_SIDED|95.0|1.347|2.109|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.109|1.347|<0.0001
91607213|NCT03068715|183106785|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.546|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.546
91607214|NCT03068715|183106785|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.607|||||||t-test, 2 sided|||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.607
91607215|NCT03068715|183106786|SUPERIORITY||P value of the interaction|0.11|||<|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons at this time.|Mixed Models Analysis|We were interested in the interaction between treatment condition and timepoint.||We conducted a linear mixed models analysis, with a focus on the interaction term. No power analysis for this measure because number of participants was determined by other primary study aims.||||<0.05
91607216|NCT03068715|183106787|SUPERIORITY|The SDNN (the standard deviation of the RR intervals) was recorded using ECG. It was not necessary to conduct a power analysis for this measure because the number of participants in the study was based on other considerations (primary treatment goals of the study).|P value of the interaction|0.245|||<|0.05|TWO_SIDED|||||For reporting purposes here the p value was not adjusted for multiple comparisons.|Mixed Models Analysis|We were interested in the significance of the interaction between treatment group and timepoint.||We used a linear mixed models analysis, with the fixed factors being treatment group and timepoint.||||<0.05
91607217|NCT00728416|183106788|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.31|||<|0.001|TWO_SIDED|95.0|-0.43|-0.19|||ANCOVA|||The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.||-0.19|-0.43|<0.001
91607218|NCT00728416|183106789|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.27|||<|0.001|TWO_SIDED|95.0|-1.72|-0.83|||ANCOVA|||The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.||-0.83|-1.72|<0.001
91607219|NCT00509106|183106801|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|-1.0|12.7|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.||12.7|-1.0|
91652498|NCT01694485|183196688|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.34||||0.011|TWO_SIDED|90.0|1.35|4.07|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors.|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.07|1.35|0.011
91607220|NCT02201940|183106866|SUPERIORITY_OR_OTHER||||||<|0.001||||||Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|Binomial test|||||||< 0.001
91607221|NCT00636818|183106873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
91607222|NCT00636818|183106874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
91652499|NCT01694485|183196688|SUPERIORITY||Difference in Adjusted Healing Rates|15.3|||||TWO_SIDED|90.0|4.8|24.0||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||24.0|4.8|
91652500|NCT01694485|183196688|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.1||||0.041|TWO_SIDED|90.0|1.15|3.82|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.82|1.15|0.041
91523506|NCT04270747|182922883|OTHER||Difference between means|-0.1|||||TWO_SIDED|90.0|-1.3|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||1.2|-1.3|
91607223|NCT00636818|183106875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
91788145|NCT03207438|183456789|SUPERIORITY||Chi-squared|1.5||||0.11|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.11
91788146|NCT03207438|183456789|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||The actual estimated Chi-squared statistic was 6.35(10\^-31)|Week 6 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.50
91607224|NCT00636818|183106876|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.013
91607225|NCT00636818|183106877|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
91652501|NCT01694485|183196688|SUPERIORITY||Difference in Adjusted Healing Rates|13.0|||||TWO_SIDED|90.0|1.7|22.1||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.1|1.7|
91607226|NCT00636818|183106878|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
91607227|NCT00636818|183106878|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Color Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
91607228|NCT00636818|183106878|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Color-Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.144
91607229|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||P-value for Physical Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.791
91709834|NCT00685360|183312367|SUPERIORITY||Risk Ratio Mean|1.416|||=|0.0393|TWO_SIDED|95.0|1.012|1.98||P-value was derived using CMH test stratified by randomization strata (cavitation).|Cochran-Mantel-Haenszel|||||1.980|1.012|=0.0393
91607230|NCT00636818|183106879|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
91607231|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Physical Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.037
91607232|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-value for Role-Physical: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.446
91709835|NCT00685360|183312379|SUPERIORITY||Risk Ratio Mean|1.599|||=|0.0021|TWO_SIDED|95.0|1.175|2.177|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||2.177|1.175|=0.0021
91788147|NCT03207438|183456790|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||Estimated chi-squared statistic was 1.88(10\^-29).|Day 4 - chi-squared test comparing response rates between groups.||||.5
91788148|NCT03207438|183456790|SUPERIORITY||Chi-squared|3.3||||0.03|TWO_SIDED||||||Chi-squared, Corrected|||Week 1 - chi-squared test comparing response rates between groups.||||.03
91788149|NCT03207438|183456790|SUPERIORITY||Chi-squared|3.87||||0.02|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - chi-squared test comparing response rates between groups.||||.02
91788150|NCT03207438|183456790|SUPERIORITY||Chi-squared|0.62||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - chi-squared test comparing response rates between groups.||||.22
91788151|NCT03207438|183456790|SUPERIORITY||Chi-squared|2.45||||0.059|TWO_SIDED||||||Chi-squared, Corrected|||Week 6 - chi-squared test comparing response rates between groups.||||.059
91607233|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-value for Bodily Pain: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.365
91607234|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-value for General Health Perception: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.087
91607235|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Vitality: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.043
91607236|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for Social Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.086
91607237|NCT00636818|183106879|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for Role-Emotional: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.010
91607238|NCT00636818|183106879|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
91607239|NCT03192904|183106899|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91607240|NCT01511445|183106926|NON_INFERIORITY|The noninferiority margin was specified as 15 NDI points (0-100 scale).|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.96||0.641|TWO_SIDED|95.0|-7.3|4.5|||Fisher Exact||A negative value means that the PEEK change was slightly larger than the silicon nitride study arm.|The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.||4.5|-7.3|0.641
91607241|NCT01511445|183106927|NON_INFERIORITY|The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.||||||0.71|||||||Fisher Exact|||The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).||||0.710
91607242|NCT00397150|183106939|SUPERIORITY_OR_OTHER||Prevalence ratio|2.29|||||TWO_SIDED|95.0|1.33|3.92||||||||3.92|1.33|
91607243|NCT00397150|183106944|SUPERIORITY_OR_OTHER||Prevalence ratio|1.89|||||TWO_SIDED|95.0|1.7|2.11||||||||2.11|1.70|
91607244|NCT00397150|183106945|SUPERIORITY_OR_OTHER||Prevalence ratio|1.72|||||TWO_SIDED|95.0|1.12|2.63||||||||2.63|1.12|
91607245|NCT01444300|183106946|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.51
91607246|NCT01444300|183106947|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo after 12 weeks.||||0.7
91607247|NCT01444300|183106948|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.8
91607248|NCT02863198|183106961|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91607249|NCT02863198|183106962|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91607250|NCT02863198|183106963|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
91607251|NCT02863198|183106964|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91607252|NCT02863198|183106965|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
91607253|NCT02863198|183106966|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
91607254|NCT01697345|183106991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.092|STANDARD_DEVIATION|6.0378|<|0.0005|TWO_SIDED|95.0|-13.928|-6.256|||t-test, 2 sided|||||-6.256|-13.928|<0.0005
91607255|NCT01697345|183106992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|0.88|<|0.0005|TWO_SIDED|95.0|-1.859|-0.741|||t-test, 2 sided|||||-0.741|-1.859|<0.0005
91607256|NCT01697345|183106993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.625|STANDARD_DEVIATION|1.369||0.002|TWO_SIDED|95.0|-2.495|-0.755|||t-test, 2 sided|||||-0.755|-2.495|0.002
91607257|NCT01697345|183106994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|1.876||0.018|TWO_SIDED|95.0|-2.692|-0.308|||t-test, 2 sided|||||-0.308|-2.692|0.018
91607258|NCT01697345|183106995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.18168||0.005|TWO_SIDED|95.0|-1.9508|-0.4492|||t-test, 2 sided|||||-.44920|-1.95080|0.005
91607259|NCT01697345|183106996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|1.355||0.001|TWO_SIDED|95.0|-2.761|-1.039|||t-test, 2 sided|||||-1.039|-2.761|0.001
91607260|NCT01697345|183106997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.567|STANDARD_DEVIATION|1.793|<|0.0005|TWO_SIDED|95.0|-3.706|-1.428|||t-test, 2 sided|||||-1.428|-3.706|<0.0005
91607261|NCT01976806|183107033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|||||||Mixed Models Analysis|Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables|Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths \>=5 mm in the DHA intervention group versus the placebo group.|Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.||||<0.05
91607262|NCT01245647|183107047|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
91607263|NCT01245647|183107048|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91607264|NCT01245647|183107049|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
91607265|NCT01245647|183107050|SUPERIORITY_OR_OTHER|||||||0.12||||||no significant difference by Fisher exact test|Fisher Exact|||||||0.12
91607266|NCT01245647|183107051|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
91607267|NCT00045032|183107095|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607268|NCT00045032|183107095|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.67|0.44|
91607269|NCT00045032|183107096|SUPERIORITY_OR_OTHER|||||||0|||||||Log Rank|||||||0.000
91607270|NCT00045032|183107096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.53|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.53|0.34|
91607271|NCT00045032|183107099|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607272|NCT00045032|183107099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.67|
91607273|NCT00045032|183107099|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607274|NCT00045032|183107099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.67|
91607275|NCT00045032|183107104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.68|
91607276|NCT00045032|183107104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.69|0.87|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.87|0.69|
91607277|NCT00045032|183107111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.7962|TWO_SIDED|95.0|0.89|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.89|0.7962
91607278|NCT00045032|183107113|SUPERIORITY_OR_OTHER|||||||0.2379|||||||Log Rank|||||||0.2379
91607279|NCT00045032|183107113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.47|1.21|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||1.21|0.47|
91652502|NCT01694485|183196688|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.8||||0.68|TWO_SIDED|90.0|0.32|1.97|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.97|0.32|0.68
91652503|NCT01694485|183196688|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-3.0|||||TWO_SIDED|90.0|-11.9|9.4||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.4|-11.9|
91709836|NCT00685360|183312379|SUPERIORITY||Risk Ratio Mean|1.939|||<|0.0001|TWO_SIDED|95.0|1.449|2.595|||Cochran-Mantel-Haenszel|||||2.595|1.449|<.0001
91709837|NCT00685360|183312380|SUPERIORITY||||||=|0.2419|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from analysis of covariance(ANCOVA)model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2419
91607280|NCT00045032|183107114|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
91607281|NCT00045032|183107114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.28|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.28|
91607282|NCT00045032|183107117|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
91607283|NCT00045032|183107117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.88|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.88|0.65|
91607284|NCT00045032|183107117|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
91607285|NCT00045032|183107117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.86|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.86|0.63|
91607286|NCT00045032|183107119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.64|
91607287|NCT00045032|183107119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.83|0.62|
91607288|NCT00045032|183107121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9156|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.21|0.84|0.9156
91607289|NCT00045032|183107123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607290|NCT00045032|183107123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
91607291|NCT00045032|183107123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607292|NCT00045032|183107123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
91607293|NCT00045032|183107125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4755|TWO_SIDED|95.0|0.8|1.11|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.11|0.80|0.4755
91607294|NCT00045032|183107127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607295|NCT00045032|183107127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.87|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.87|0.67|
91607296|NCT00045032|183107127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607297|NCT00045032|183107127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.65|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.65|
91607298|NCT00045032|183107129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9626|TWO_SIDED|95.0|0.85|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.85|0.9626
91607299|NCT00045032|183107131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607300|NCT00045032|183107131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
91607301|NCT00045032|183107131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607302|NCT00045032|183107131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
91607303|NCT00045032|183107133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.45|TWO_SIDED|95.0|0.8|1.1|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.10|0.80|0.4500
91709838|NCT00685360|183312380|SUPERIORITY||||||=|0.2239|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2239
91709839|NCT00685360|183312380|SUPERIORITY||||||=|0.9544|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.9544
91709840|NCT00685360|183312381|SUPERIORITY||||||=|0.0246|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0246
91607304|NCT00045032|183107135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607305|NCT00045032|183107135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.62|
91607306|NCT00045032|183107135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91607307|NCT00045032|183107135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.59|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.59|
91607308|NCT00045032|183107137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.6823|TWO_SIDED|95.0|0.8|1.15|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.15|0.80|0.6823
91607309|NCT00045032|183107139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.7251|TWO_SIDED|95.0|0.84|1.13|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.13|0.84|0.7251
91607310|NCT04364854|183107182|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-2.31|1.87|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.87|-2.31|
91607311|NCT04364854|183107182|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.94|3.15|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||3.15|-2.94|
91607312|NCT04364854|183107182|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-2.9|1.33|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.33|-2.9|
91607313|NCT04364854|183107183|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.26|0.13|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.13|-0.26|
91607314|NCT04364854|183107183|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.28|-0.21|
91607315|NCT04364854|183107183|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.42|-0.04|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||-0.04|-0.42|
91607316|NCT04364854|183107184|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-2.59|2.9|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.9|-2.59|
91709841|NCT00685360|183312381|SUPERIORITY||||||=|0.0529|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0529
91607317|NCT04364854|183107184|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|-2.23|3.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM-Narrative, and age.|||3.8|-2.23|
91607318|NCT04364854|183107184|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-2.32|2.82|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.82|-2.32|
91607319|NCT04364854|183107185|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-3.59|3.45|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||3.45|-3.59|
91607320|NCT04364854|183107185|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-4.27|4.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||4.8|-4.27|
91607321|NCT04364854|183107185|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-2.11|||||TWO_SIDED|95.0|-5.77|1.56|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||1.56|-5.77|
91607322|NCT03528681|183107204|OTHER||Back-transformed mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.902|0.959|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.959|0.902|<0.001
91709842|NCT00685360|183312381|SUPERIORITY||||||=|0.7508|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.7508
91709843|NCT00685360|183312382|SUPERIORITY||Risk Ratio Mean|1.272|||=|0.0518|TWO_SIDED|95.0|0.995|1.627|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.627|0.995|=0.0518
91709844|NCT00685360|183312382|SUPERIORITY||Risk Ratio Mean|1.203|||=|0.1506|TWO_SIDED|95.0|0.934|1.55|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.550|0.934|=0.1506
91607323|NCT03528681|183107204|OTHER||Back-transformed mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.825|0.876|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.876|0.825|<0.001
91607324|NCT03528681|183107209|OTHER|The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|2.17|6.67|||Mixed Models Analysis|||||6.67|2.17|<0.001
91607325|NCT03528681|183107209|OTHER||Odds Ratio (OR)|11.63|||<|0.001|TWO_SIDED|95.0|6.45|21.0|||Mixed Models Analysis|||The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.||21.00|6.45|<0.001
91607326|NCT03528681|183107210|OTHER|The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|2.54||||0.035|TWO_SIDED|95.0|1.07|6.05|||Regression, Logistic|||||6.05|1.07|0.035
91607327|NCT03528681|183107210|OTHER||Odds Ratio (OR)|6.25|||<|0.001|TWO_SIDED|95.0|2.56|15.27|||Regression, Logistic|||The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.||15.27|2.56|<0.001
91607328|NCT03528681|183107211|OTHER||Median Difference (Final Values)|5.72|||<|0.001|TWO_SIDED|95.0|3.13|8.31|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||8.31|3.13|<0.001
91607329|NCT03528681|183107211|OTHER||Mean Difference (Final Values)|11.14|||<|0.001|TWO_SIDED|95.0|8.57|13.71|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||13.71|8.57|<0.001
91607330|NCT03528681|183107214|OTHER||Mean Difference (Final Values)|-105.248|||<|0.001|TWO_SIDED|95.0|-161.293|-49.203|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-49.203|-161.293|<0.001
91652504|NCT01694485|183196688|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.69||||0.6|TWO_SIDED|90.0|0.21|2.22|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.22|0.21|0.60
91652505|NCT01694485|183196688|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-4.6|||||TWO_SIDED|90.0|-14.9|11.3||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.3|-14.9|
91652506|NCT01694485|183196689|SUPERIORITY||Odds Ratio (OR)|2.94||||0.09|TWO_SIDED|90.0|1.03|8.36|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.36|1.03|0.090
91652507|NCT01694485|183196689|SUPERIORITY||Difference in Adjusted Remission Rates|5.8|||||TWO_SIDED|90.0|-0.6|10.4||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.4|-0.6|
91652508|NCT01694485|183196689|SUPERIORITY||Odds Ratio (OR)|1.32||||0.72|TWO_SIDED|90.0|0.38|4.56|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.56|0.38|0.72
91788152|NCT03241368|183456791|OTHER|Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule \[referred to as capsule endoscopy (CE)\] as compared to IC with MRE.||||||0.125|||||||McNemar|Exact McNemar's test||This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.||||0.125
91607331|NCT03528681|183107214|OTHER||Median Difference (Final Values)|-137.267|||<|0.001|TWO_SIDED|95.0|-192.596|-81.937|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-81.937|-192.596|<0.001
91607332|NCT03528681|183107214|OTHER||Mean Difference (Final Values)|0.014||||0.839|TWO_SIDED|95.0|-0.12|0.147|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.147|-0.120|0.839
91607333|NCT03528681|183107214|OTHER||Mean Difference (Final Values)|-0.062||||0.355|TWO_SIDED|95.0|-0.195|0.07|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.070|-0.195|0.355
91709845|NCT00685360|183312383|SUPERIORITY||Risk Ratio Mean|1.234|||=|0.1201|TWO_SIDED|95.0|0.945|1.612|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.612|0.945|=0.1201
91607334|NCT03528681|183107216|OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.27|0.57|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.57|0.27|<0.001
91607335|NCT03528681|183107216|OTHER||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.25|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.25|0.10|<0.001
91607336|NCT01232946|183107219|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
91607337|NCT01232946|183107220|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
91607338|NCT01232946|183107221|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||||||0.80
91607339|NCT01614457|183107222|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|2.1114||||0.1979|TWO_SIDED|95.0|-1.1305|5.3532|||Mixed Model Repeated Measures|||Analysis was based on mixed effects model for repeated measures (MMRM) with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, using compound symmetry covariance matrix.||5.3532|-1.1305|0.1979
91607340|NCT01614457|183107223|SUPERIORITY_OR_OTHER||LS Mean difference|0.2626||||0.778|TWO_SIDED|95.0|-1.5698|2.095||p-value for the treatment effect is from the slope of BMI (kg/m2) versus time (days).|Linear Mixed model|||Analysis was based on linear mixed model with dependent variable BMI and treatment as a fixed effect, adjustment for baseline percent predicted FEV1, age and visit by treatment interaction was included as covariates and intercept, visit were included as random effects.||2.0950|-1.5698|0.7780
91607341|NCT01614457|183107224|SUPERIORITY_OR_OTHER||LS Mean difference|-23.9693|||<|0.0001|TWO_SIDED|95.0|-28.0094|-19.9293|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and sweat chloride, using a compound symmetry covariance matrix.||-19.9293|-28.0094|<0.0001
91607342|NCT01614457|183107225|SUPERIORITY_OR_OTHER||LS Mean difference|8.3874||||0.0091|TWO_SIDED|95.0|2.1658|14.609|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and CFQ-R respiratory domain score, using compound symmetry covariance matrix.||14.6090|2.1658|0.0091
91607343|NCT01614457|183107226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.8556|TWO_SIDED||||||Cox Proportional Hazard Regression|||||||0.8556
91607344|NCT03518840|183107233|SUPERIORITY||Mean Difference (Final Values)|-1.9615|STANDARD_ERROR_OF_MEAN|0.3329|<|0.001|TWO_SIDED|95.0|-2.6299|-1.2932|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.||-1.2932|-2.6299|<.001
91607345|NCT03518840|183107234|SUPERIORITY||Median Difference (Final Values)|-1.9474|STANDARD_ERROR_OF_MEAN|0.3353|<|0.001|TWO_SIDED|95.0|-2.619|-1.2757|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.||-1.2757|-2.6190|<.001
91607346|NCT00473694|183107261|SUPERIORITY||Estimated Treatment Effect|17.29|||<|0.0001|TWO_SIDED|95.0|13.95|21.42||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.42|13.95|<0.0001
91607347|NCT00473694|183107262|SUPERIORITY||Estimated Treatment Effect|14.86|||<|0.0001|TWO_SIDED|95.0|10.18|21.67||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.67|10.18|<0.0001
91607348|NCT00473694|183107263|SUPERIORITY||Estimated Treatment Effect|15.84|||<|0.0001|TWO_SIDED|95.0|12.58|19.95||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||19.95|12.58|<0.0001
91607349|NCT00473694|183107264|SUPERIORITY||Estimated Treatment Effect|18.45|||<|0.0001|TWO_SIDED|95.0|13.98|24.35||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.35|13.98|<0.0001
91709846|NCT00685360|183312383|SUPERIORITY||Risk Ratio Mean|1.099|||=|0.5112|TWO_SIDED|95.0|0.829|1.456|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.456|0.829|=0.5112
91709847|NCT00685360|183312384|SUPERIORITY||Risk Ratio Mean|1.323|||=|0.0141|TWO_SIDED|95.0|1.053|1.661|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.661|1.053|=0.0141
91709848|NCT00685360|183312384|SUPERIORITY||Risk Ratio Mean|1.438|||=|0.0008|TWO_SIDED|95.0|1.155|1.791|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.791|1.155|=0.0008
91607350|NCT00473694|183107265|SUPERIORITY||Estimated Treatment Effect|17.04|||<|0.0001|TWO_SIDED|95.0|13.62|21.31||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.31|13.62|<0.0001
91607351|NCT00473694|183107266|SUPERIORITY||Estimated Treatment Effect|17.7|||<|0.0001|TWO_SIDED|95.0|12.85|24.38||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.38|12.85|<0.0001
91607352|NCT01416181|183107312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.2866|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 2 years||1.13|0.66|0.2866
91607353|NCT01416181|183107312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.753|TWO_SIDED|95.0|0.74|1.53|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS||1.53|0.74|0.7530
91607354|NCT01416181|183107312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9137|TWO_SIDED|95.0|0.74|1.3|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW||1.30|0.74|0.9137
91607355|NCT01416181|183107312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0012|TWO_SIDED|95.0|0.4|0.8|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (either hand)||0.80|0.40|0.0012
91607356|NCT01416181|183107312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.1251|TWO_SIDED|95.0|0.48|1.09|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (dominant hand)||1.09|0.48|0.1251
91607357|NCT01416181|183107312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.0091|TWO_SIDED|95.0|0.39|0.87|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (non-dominant hand)||0.87|0.39|0.0091
91607358|NCT01416181|183107314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.4369|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6) and T25FW.|active/placebo|||1.70|0.80|0.4369
91607359|NCT01416181|183107315|SUPERIORITY_OR_OTHER|||||||0.5409|||||||ANCOVA|p-value for comparison between the active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL MSWS-12.||||||0.5409
91607360|NCT01416181|183107316|SUPERIORITY_OR_OTHER|||||||0.2586|||||||ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL ABILHAND.||||||0.2586
91607361|NCT01416181|183107317|SUPERIORITY_OR_OTHER|||||||0.1529|||||||ANCOVA|p-value for comparison between active \& placebo groups at Wk 96 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.1529
91607362|NCT01416181|183107318|SUPERIORITY_OR_OTHER|||||||0.2424||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL brain volume.||Only participants with BL brain volume are included in the p-value calculation.||||0.2424
91607363|NCT01416181|183107319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.1052|TWO_SIDED|95.0|0.58|1.05|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6).||||1.05|0.58|0.1052
91607364|NCT01416181|183107320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0205|TWO_SIDED|95.0|0.47|0.94|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 156 weeks||0.94|0.47|0.0205
91607365|NCT01416181|183107320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1305|TWO_SIDED|95.0|0.48|1.1|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS at 156 weeks||1.10|0.48|0.1305
91607366|NCT01416181|183107320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.1988|TWO_SIDED|95.0|0.57|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW at 156 weeks||1.12|0.57|0.1988
91607367|NCT01416181|183107320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0093|TWO_SIDED|95.0|0.39|0.88|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (either hand) at 156 weeks||0.88|0.39|0.0093
91607368|NCT01416181|183107320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.054|TWO_SIDED|95.0|0.39|1.01|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors onm 9HPT (dominant hand) at 156 weeks||1.01|0.39|0.0540
91607369|NCT01416181|183107320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.141|TWO_SIDED|95.0|0.44|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (non-dominant hand) at 156 weeks||1.12|0.44|0.1410
91607370|NCT01416181|183107321|SUPERIORITY_OR_OTHER|||||||0.0273|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Week 156||||0.0273
91607371|NCT01416181|183107321|SUPERIORITY_OR_OTHER|||||||0.1974|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.1974
91607372|NCT01416181|183107321|SUPERIORITY_OR_OTHER|||||||0.2506|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2506
91607373|NCT01416181|183107322|SUPERIORITY_OR_OTHER|||||||0.096|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Overall: Week 156||||0.0960
91607374|NCT01416181|183107322|SUPERIORITY_OR_OTHER|||||||0.4957|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.4957
91607375|NCT01416181|183107322|SUPERIORITY_OR_OTHER|||||||0.2916|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2916
91607376|NCT01416181|183107323|SUPERIORITY_OR_OTHER|||||||0.1119|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall, Week 156||||0.1119
91607377|NCT01416181|183107323|SUPERIORITY_OR_OTHER|||||||0.1129|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.1129
91607378|NCT01416181|183107323|SUPERIORITY_OR_OTHER|||||||0.2351|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.2351
91607379|NCT01416181|183107324|SUPERIORITY_OR_OTHER|||||||0.0261|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall: Week 156||||0.0261
91652509|NCT01694485|183196689|SUPERIORITY||Difference in Adjusted Remission Rates|1.0|||||TWO_SIDED|90.0|-4.7|4.6||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.6|-4.7|
91652510|NCT01694485|183196689|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.83||||0.86|TWO_SIDED|90.0|0.16|4.41|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.41|0.16|0.86
91652511|NCT01694485|183196689|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-0.5|||||TWO_SIDED|90.0|-3.9|6.2||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.2|-3.9|
91709849|NCT00685360|183312385|SUPERIORITY||Risk Ratio Mean|1.341|||=|0.0196|TWO_SIDED|95.0|1.044|1.722|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.722|1.044|=0.0196
91607380|NCT01416181|183107324|SUPERIORITY_OR_OTHER|||||||0.0585|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.0585
91607381|NCT01416181|183107324|SUPERIORITY_OR_OTHER|||||||0.6095|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.6095
91607382|NCT01416181|183107325|SUPERIORITY_OR_OTHER|||||||0.723|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.7230
91607383|NCT01416181|183107325|SUPERIORITY_OR_OTHER|||||||0.8781|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.8781
91607384|NCT01416181|183107325|SUPERIORITY_OR_OTHER|||||||0.2751|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.2751
91607385|NCT01416181|183107326|SUPERIORITY_OR_OTHER|||||||0.5051|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.5051
91607386|NCT01416181|183107326|SUPERIORITY_OR_OTHER|||||||0.7283|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.7283
91607387|NCT01416181|183107326|SUPERIORITY_OR_OTHER|||||||0.1666|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.1666
91607388|NCT01416181|183107327|SUPERIORITY_OR_OTHER|||||||0.433|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.4330
91607389|NCT01416181|183107327|SUPERIORITY_OR_OTHER|||||||0.7122|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.7122
91607390|NCT01416181|183107327|SUPERIORITY_OR_OTHER|||||||0.3861|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.3861
91607391|NCT01416181|183107328|SUPERIORITY_OR_OTHER|||||||0.7225|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.7225
91607392|NCT01416181|183107328|SUPERIORITY_OR_OTHER|||||||0.9121|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.9121
91607393|NCT01416181|183107328|SUPERIORITY_OR_OTHER|||||||0.2594|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.2594
91607394|NCT01416181|183107329|SUPERIORITY_OR_OTHER|||||||0.8066|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 6MWT.||Week 156||||0.8066
91523507|NCT04270747|182922883|OTHER||Difference between means|-0.8|||||TWO_SIDED|90.0|-2.3|0.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||0.7|-2.3|
91607395|NCT01416181|183107331|SUPERIORITY_OR_OTHER|||||||0.7084|||||||ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.7084
91607396|NCT01416181|183107333|SUPERIORITY_OR_OTHER|||||||0.3465|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL SDMT.||Week 156||||0.3465
91652512|NCT01694485|183196689|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.49||||0.64|TWO_SIDED|90.0|0.04|6.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.31|0.04|0.64
91652513|NCT01694485|183196689|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.7|||||TWO_SIDED|90.0|-4.2|6.4||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.4|-4.2|
91652514|NCT02907203|183196690|NON_INFERIORITY|Compared with the Performance Goal: 0.9mm|Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.98||0|TWO_SIDED|95.0|-0.5|0.152|||t-test, 2 sided|||||0.152|-0.5|0.000
91791019|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.58||0.316|TWO_SIDED|95.0|-1.723|0.558||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.558|-1.723|0.316
91652515|NCT00952484|183196692|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value based on Wilcoxon rank sum test comparing the median RGI-C score for the asfotase alfa combined reporting group to the historical control group.|Wilcoxon (Mann-Whitney)|||||||0.0007
91523508|NCT04270747|182922883|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-1.9|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.2|-1.9|
91523509|NCT04270747|182922883|OTHER||Difference between means|0.4|||||TWO_SIDED|90.0|-1.3|2.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.1|-1.3|
91652516|NCT00952484|183196693|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0097
91652517|NCT00952484|183196694|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0789
91791020|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791021|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.567||0.336|TWO_SIDED|95.0|-1.66|0.569||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.569|-1.660|0.336
91791022|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791023|NCT02880956|183460091|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.587||0.403|TWO_SIDED|95.0|-1.647|0.663||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.663|-1.647|0.403
91791024|NCT02880956|183460091|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791025|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.4||0.861|TWO_SIDED|95.0|-0.856|0.716||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.716|-0.856|0.861
91791026|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|3.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791027|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.395||0.746|TWO_SIDED|95.0|-0.648|0.905||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.905|-0.648|0.746
91791028|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791029|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.405||0.859|TWO_SIDED|95.0|-0.724|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.868|-0.724|0.859
91791030|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91607397|NCT01416181|183107337|SUPERIORITY_OR_OTHER|||||||0.007||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL normalized brain volume.||Percentage change from Week 24 to Week 156||||0.0070
91607398|NCT01416181|183107338|SUPERIORITY_OR_OTHER|||||||0.5034||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL WGM brain volume||Percentage hange from Baseline to Week 156||||0.5034
91652518|NCT00952484|183196695|SUPERIORITY_OR_OTHER|||||||0.7417|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.7417
91652519|NCT00952484|183196696|SUPERIORITY_OR_OTHER|||||||0.757|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a Wilcoxon Signed-Rank test.|Wilcoxon Signed-Rank|||||||0.7570
91652520|NCT00952484|183196697|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||<0.0001
91652521|NCT00952484|183196698|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0007
91652522|NCT02750306|183196705|SUPERIORITY||Difference in Least Squares Means|28.2||||0.00128|TWO_SIDED|95.0|11.1|45.2|||ANCOVA|||||45.2|11.1|0.00128
91652523|NCT02750306|183196708|SUPERIORITY||Difference in Least Squares Means|-15.7||||0.01354|TWO_SIDED|95.0|-28.1|-3.3|||ANCOVA|||||-3.3|-28.1|0.01354
91652524|NCT02422290|183196709|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|1.83||0.2|TWO_SIDED|95.0|-2.27|7.87|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CY-BOCS scores at the time points Baseline and Day 14.||7.87|-2.27|.20
91652525|NCT02422290|183196710|SUPERIORITY||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|0.49||0.18|TWO_SIDED|95.0|-0.56|2.16|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CGI-S scores at the time points Baseline and Day 14.||2.16|-.56|.18
91791031|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|0.467||0.24|TWO_SIDED|95.0|-0.369|1.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.469|-0.369|0.240
91607399|NCT01416181|183107339|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the active and placebo groups at Week 156 compared to Week 108 is based on negative binomial regression model, adjusted for baseline EDSS (\<=5.5 or \>=6) and baseline volume of T2 lesions.|negative binomial regression model|natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment||Week 156||||< 0.0001
91607400|NCT00486902|183107346|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Fisher Exact|||Sample size was determined assuming an incidence of breakthrough pain of 75% and an absolute difference between groups of -20 to +15%. This rate of request for analgesia in the first 24 h was based on data from a parallel study utilizing the same multimodal postoperative pain regimen for cesarean delivery. Group sample sizes of 90 achieve 80% power to detect this difference using the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.05.||||0.86
91652526|NCT02422290|183196711|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||1|TWO_SIDED|95.0|-2.78|2.78|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||2.78|-2.78|1.00
91652527|NCT02422290|183196712|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|5.41||0.77|TWO_SIDED|95.0|-15.46|18.96|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||18.96|-15.46|.77
91652528|NCT00457665|183196744|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||||||0.94
91652529|NCT01102777|183196770|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.||||||0.142
91652530|NCT01102777|183196771|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||.502
91652531|NCT01102777|183196772|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.90
91652532|NCT01102777|183196773|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.93
91652533|NCT01102777|183196774|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Zero inflated Poisson regression|Adjusted for age, gender, oxygen use, and arm.||||||.08
91652534|NCT01102777|183196775|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||0.731
91652535|NCT01102777|183196776|SUPERIORITY_OR_OTHER|||||||0.52|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.52
91652536|NCT01102777|183196777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|||||||||The determination of arm occurred after recruitment, and Study Reach is a recruitment value.||||
91652537|NCT01102777|183196778|SUPERIORITY_OR_OTHER|||||||0.11|||||||Regression, Linear|Adjusting for time, MMRC score, and urban versus rural residence.||||||.11
91652538|NCT01102777|183196779|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.01
91652539|NCT00210626|183196816|SUPERIORITY_OR_OTHER|||||||0.3807||95.0|||||ANCOVA|Covariate used is Baseline SF-36 PF Score. Baseline SF-36 PF Score was collected prior to the start of Procrit or Placebo treatment||The null hypothesis is that there is no difference between Procrit and Placebo in average SF-36 Physical Function Scores||||0.3807
91652540|NCT00210626|183196817|SUPERIORITY_OR_OTHER|||||||0.7038||95.0|||||Chi-squared|||||||0.7038
91709850|NCT00685360|183312385|SUPERIORITY||Risk Ratio Mean|1.503|||=|0.0006|TWO_SIDED|95.0|1.183|1.909|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.909|1.183|=0.0006
91607401|NCT00486902|183107347|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
91607402|NCT00486902|183107348|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
91652541|NCT04147715|183196873|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9913|||||TWO_SIDED|90.0|0.9232|1.0645|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by analysis of variance (ANOVA) fit with a linear mixed effect model with the natural log (ln)-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% confidence interval (CI) between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0645|0.9232|
91652542|NCT04147715|183196873|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9754|||||TWO_SIDED|90.0|0.8916|1.0671|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% CI between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0671|0.8916|
91652543|NCT04147715|183196875|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0353|||||TWO_SIDED|90.0|0.9421|1.1377|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1377|0.9421|
91709851|NCT00685360|183312386|SUPERIORITY||||||=|0.0468|||||||Cochran-Armitage Linear Trend Test|Cochran-Armitage test was performed for dose response with the treatment group ordered as placebo, delamanid 100 mg BID, and delamanid 200 mg BID.||||||=0.0468
91709852|NCT00685360|183312387|SUPERIORITY||Hazard Ratio (HR)|1.856|||=|0.0011|TWO_SIDED|95.0|1.255|2.745|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.745|1.255|=0.0011
91788153|NCT01270802|183456822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.76||0.67|TWO_SIDED|95.0|-0.75|2.37||P-value was not adjusted for multiple comparisons; P\<0.05 was considered statistically significant.|t-test, 2 sided|||We assumed that the declines in FMD seen with TDF/FTC/EFV in our previous study would fully reverse. Thus, the clinically relevant effect size to be detected for FMD change was +3.12% (SD 4%) in those switching from EFV to RAL. Using a two-sample, independent, two-tailed t-test with 5% type I error and 20% type II error, a sample size of 13 per group would be needed to find a difference in FMD between groups. Allowing for a 10% dropout rate, we planned to recruit 15 subjects per group.||2.37|-0.75|0.67
91788154|NCT01270802|183456823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|5.52||0.4|TWO_SIDED|95.0|-13.04|9.77||P-value was not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.|t-test, 2 sided|||||9.77|-13.04|0.40
91607403|NCT00486902|183107349|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||||||0.87
91607404|NCT00486902|183107350|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Fisher Exact|||||||0.90
91607405|NCT00486902|183107351|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
91607406|NCT00486902|183107352|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91607407|NCT00486902|183107353|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.6||||0.02|TWO_SIDED|95.0|-1.1|-0.09|||Wilcoxon (Mann-Whitney)|||||-0.09|-1.1|0.02
91607408|NCT04178590|183107359|SUPERIORITY|||||||0.429||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.429
91607409|NCT04178590|183107360|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607410|NCT04178590|183107361|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607411|NCT04178590|183107362|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607412|NCT04178590|183107363|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
91607413|NCT04178590|183107364|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
91607414|NCT04178590|183107365|SUPERIORITY|||||||0.249||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.249
91607415|NCT04178590|183107366|SUPERIORITY|||||||0.871||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.871
91607416|NCT04178590|183107367|SUPERIORITY|||||||0.773||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.773
91607417|NCT04178590|183107368|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607418|NCT04178590|183107369|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|p\<0.05||||||0.000
91607419|NCT04178590|183107370|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607420|NCT04178590|183107371|SUPERIORITY|||||||0.063||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.063
91607421|NCT04178590|183107372|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91709853|NCT00685360|183312387|SUPERIORITY||Hazard Ratio (HR)|1.849|||=|0.0013|TWO_SIDED|95.0|1.246|2.743|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.743|1.246|=0.0013
91709854|NCT00685360|183312388|SUPERIORITY||Hazard Ratio (HR)|1.926|||=|0.0004|TWO_SIDED|95.0|1.315|2.82|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.820|1.315|=0.0004
91709855|NCT00685360|183312388|SUPERIORITY||Hazard Ratio (HR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.504|3.189|||Stratified Log-Rank Test|||||3.189|1.504|<.0001
91709856|NCT00685360|183312389|SUPERIORITY||Hazard Ratio (HR)|1.727|||=|0.0056|TWO_SIDED|95.0|1.152|2.591|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.591|1.152|=0.0056
91523510|NCT04270747|182922883|OTHER||Difference between means|-1.3|||||TWO_SIDED|90.0|-3.1|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.5|-3.1|
91523511|NCT04270747|182922883|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-2.3|1.4|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||1.4|-2.3|
91607422|NCT04178590|183107373|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607423|NCT04178590|183107374|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607424|NCT04178590|183107375|SUPERIORITY|||||||0.085||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.085
91607425|NCT04178590|183107376|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607426|NCT04178590|183107377|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607427|NCT04178590|183107378|SUPERIORITY|||||||0.895||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.895
91607428|NCT04178590|183107379|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
91607429|NCT04178590|183107380|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
91607430|NCT04178590|183107381|SUPERIORITY|||||||0.008||||||p\<0.05|McNemar|||||||0.008
91607431|NCT04178590|183107382|SUPERIORITY|||||||0.5||||||p\<0.05|McNemar|||||||0.500
91607432|NCT04178590|183107383|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
91607433|NCT04178590|183107384|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
91607434|NCT04178590|183107385|SUPERIORITY|||||||0.4||||||p\<0.05|McNemar|||||||0.40
91607435|NCT04178590|183107386|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
91607436|NCT04178590|183107387|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
91607437|NCT04178590|183107388|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
91607438|NCT04178590|183107389|SUPERIORITY|||||||0.453||||||p\<0.05|McNemar|||||||0.453
91607439|NCT04178590|183107390|SUPERIORITY|||||||0.625||||||p\<0.05|McNemar|||||||0.625
91607440|NCT04178590|183107391|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
91607441|NCT04178590|183107392|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
91607442|NCT04178590|183107393|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
91607443|NCT04178590|183107394|SUPERIORITY|||||||0.065||||||p\<0.05|McNemar|||||||0.065
91607444|NCT04178590|183107395|SUPERIORITY|||||||0.821||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.821
91607445|NCT04178590|183107396|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607446|NCT04178590|183107397|SUPERIORITY|||||||0.001||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
91607447|NCT04178590|183107398|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91709857|NCT00685360|183312389|SUPERIORITY||Hazard Ratio (HR)|1.585|||=|0.0232|TWO_SIDED|95.0|1.048|2.399|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.399|1.048|=0.0232
91709858|NCT00685360|183312390|SUPERIORITY||Hazard Ratio (HR)|1.846|||=|0.0016|TWO_SIDED|95.0|1.235|2.759|||Stratified Log-Rank Test|P-value was derived from log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.759|1.235|=0.0016
91709859|NCT00685360|183312390|SUPERIORITY||Hazard Ratio (HR)|2.301|||<|0.0001|TWO_SIDED|95.0|1.555|3.405|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||3.405|1.555|<.0001
91709860|NCT04274075|183312406|OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.945|1.12|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.12|0.945|
91709861|NCT04274075|183312406|OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.726|0.859|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.859|0.726|
91709862|NCT04274075|183312407|OTHER||Median Difference (Net)|0.525|||||TWO_SIDED|90.0|-0.225|1.5|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.50|-0.225|
91607448|NCT04178590|183107399|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607449|NCT04178590|183107400|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607450|NCT04178590|183107401|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607451|NCT04178590|183107402|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
91607452|NCT04178590|183107403|SUPERIORITY|||||||0.671||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.671
91607453|NCT04178590|183107404|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607454|NCT04178590|183107405|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607455|NCT04178590|183107406|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
91652544|NCT04147715|183196875|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9096|||||TWO_SIDED|90.0|0.8791|0.9411|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||0.9411|0.8791|
91709863|NCT04274075|183312407|OTHER||Median Difference (Net)|1.98|||||TWO_SIDED|90.0|1.26|2.45|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||2.45|1.26|
91709864|NCT04274075|183312410|OTHER||Geometric Mean Ratio|0.971|||||TWO_SIDED|90.0|0.903|1.04|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.04|0.903|
91607456|NCT04178590|183107407|SUPERIORITY|||||||0.753||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.753
91607457|NCT04178590|183107408|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607458|NCT04178590|183107409|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607459|NCT04178590|183107410|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
91607460|NCT02513940|183107430|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91607461|NCT02513940|183107431|SUPERIORITY|||||||0.001||||||"Pairwise comparisons:~Testosterone vs placebo: p=0.008 Progesterone vs placebo: p=0.73 Testosterone vs progesterone: p=0.0008"|Mixed Models Analysis|||||||0.001
91607462|NCT02513940|183107432|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Repeated measures ANOVA||||||0.60
91607463|NCT02513940|183107433|SUPERIORITY|||||||0.0003||||||"Pairwise comparisons:~Testosterone vs placebo: p = 0.0001 Progesterone vs placebo: p = 0.25 Testosterone vs progesterone: p = 0.002"|Mixed Models Analysis|Repeated measures ANOVA||||||0.0003
91607464|NCT02513940|183107434|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Fatigue||||>0.99
91607465|NCT02513940|183107434|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Rash at gel application site||||>0.99
91607466|NCT01485614|183107437|SUPERIORITY||Least Squares Means Difference|-0.19|||=|0.448|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin is compared against that of Placebo (pooled)."||||0.30|-0.68|= 0.448
91607467|NCT01485614|183107439|OTHER||Difference in Percentage|2.4|||||TWO_SIDED|95.0|-10.0|14.9||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||14.9|-10.0|
91607468|NCT01485614|183107441|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-1.3|10.8||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||10.8|-1.3|
91607469|NCT01485614|183107444|SUPERIORITY||Difference in percentage|6.7|||=|0.374|TWO_SIDED|95.0|-8.1|21.2||"Percentage of participants with an A1C goal (7.0%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|Miettinen and Nurminen||||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the Linear Discriminant Analysis (LDA) model was used to impute whether the participant had met the goal.|21.2|-8.1|= 0.374
91607470|NCT01485614|183107446|SUPERIORITY||Difference in percentage|3.6|||=|0.639|TWO_SIDED|95.0|-11.6|18.3|||Miettinen and Nurminen|"The percentage of participants with an A1C at the A1C goal (6.5%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the LDA model was used to impute whether the participant had met the goal.|18.3|-11.6|= 0.639
91607471|NCT01485614|183107451|SUPERIORITY||Least Squares Means Difference|1.5|||=|0.849|TWO_SIDED|95.0|-14.4|17.5|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin was compared against that of Placebo (pooled)."||||17.5|-14.4|= 0.849
91607472|NCT00733902|183107527|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.32|-0.14|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-1.32|0.015
91607473|NCT00733902|183107527|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|-1.43|-0.25|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-1.43|0.005
91607474|NCT00733902|183107527|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.78|-0.61|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.61|-1.78|<0.001
91607475|NCT00733902|183107528|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.29||0.009|TWO_SIDED|95.0|-1.32|-0.19|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-1.32|0.009
91607476|NCT00733902|183107528|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.54|-0.41|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.54|<0.001
91652545|NCT04147715|183196876|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0071|||||TWO_SIDED|90.0|0.9679|1.0479|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0479|0.9679|
91652546|NCT04147715|183196876|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9852|||||TWO_SIDED|90.0|0.9605|1.0105|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0105|0.9605|
91652547|NCT04147715|183196878|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1806|||||TWO_SIDED|90.0|1.1171|1.2477|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2477|1.1171|
91652548|NCT04147715|183196878|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.048|||||TWO_SIDED|90.0|0.9656|1.1373|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1373|0.9656|
91709865|NCT04274075|183312410|OTHER||Geometric Mean Ratio|0.919|||||TWO_SIDED|90.0|0.855|0.988|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.988|0.855|
91709866|NCT04274075|183312411|OTHER||Geometric Mean Ratio|0.975|||||TWO_SIDED|90.0|0.908|1.05|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.05|0.908|
91709867|NCT04274075|183312411|OTHER||Geometric Mean Ratio|0.918|||||TWO_SIDED|90.0|0.856|0.985|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.985|0.856|
91788155|NCT04620798|183456837|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.07|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.07|0.96|
91607477|NCT00733902|183107528|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.8|-0.68|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.68|-1.80|<0.001
91607478|NCT00733902|183107529|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.52|-0.13|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.13|-0.52|0.001
91709868|NCT01386944|183312426|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-0.5|||||TWO_SIDED|95.0|-1.0|-0.5||||||||-0.5|-1.0|
91607479|NCT00733902|183107529|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.56|<0.001
91709869|NCT01386944|183312427|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-1.5|||||TWO_SIDED|95.0|-1.5|-1.0||||||||-1.0|-1.5|
91607480|NCT00733902|183107529|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.31|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.31|-0.70|<0.001
91607481|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
91709870|NCT01386944|183312428|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
91709871|NCT01386944|183312429|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
91652549|NCT04147715|183196880|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.3445|||||TWO_SIDED|90.0|1.2352|1.4636|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.4636|1.2352|
91652550|NCT04147715|183196880|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0769|||||TWO_SIDED|90.0|1.0137|1.1441|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1441|1.0137|
91788156|NCT04620798|183456837|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.44|0.77|
91607482|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
91607483|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
91607484|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.47|-0.4|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.40|-1.47|<0.001
91607485|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.013|TWO_SIDED|95.0|-1.22|-0.15|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-1.22|0.013
91607486|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-1.57|<0.001
91607487|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|-1.36|-0.28|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-1.36|0.003
91607488|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.29|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.29|0.006
91607489|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.87|-0.79|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.87|<0.001
91709872|NCT01386944|183312430|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
91709873|NCT01386944|183312431|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
91709874|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91791032|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91607490|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.68|-0.53|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.68|<0.001
91607491|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.48|-0.33|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.33|-1.48|0.002
91607492|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.87|-0.72|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.87|<0.001
91607493|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.31||0.027|TWO_SIDED|95.0|-1.28|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.28|0.027
91607494|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.31||0.071|TWO_SIDED|95.0|-1.15|0.05|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.05|-1.15|0.071
91607495|NCT00733902|183107530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-1.78|-0.58|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.78|<0.001
91652551|NCT04147715|183196881|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1939|||||TWO_SIDED|90.0|1.1176|1.2754|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2754|1.1176|
91652552|NCT04147715|183196881|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0482|||||TWO_SIDED|90.0|0.9881|1.1119|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1119|0.9881|
91652553|NCT04147715|183196883|OTHER||Slope|0.9857|||||TWO_SIDED|95.0|0.9341|1.0373||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(Cmax) = Intercept + Slope × ln(Dose) + Random error||1.0373|0.9341|
91652554|NCT04147715|183196883|OTHER||Geometric Least Squares Mean Ratio|0.8786|||||TWO_SIDED|90.0|0.7705|1.0019|||||Ratio = Fed / Fasted|"The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed state and fasted state using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as random effect.~The difference and 90% CI between the fed and fasted state ln-transformed Cmax were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.0019|0.7705|
91652555|NCT04147715|183196885|OTHER||Slope|1.0252|||||TWO_SIDED|95.0|0.984|1.0665||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-last) = Intercept + Slope × ln(Dose) + Random error||1.0665|0.9840|
91709875|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91607496|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
91607497|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
91607498|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
91607499|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
91652556|NCT04147715|183196885|OTHER||Geometric Least Squares Mean Ratio|0.9598|||||TWO_SIDED|90.0|0.8585|1.073|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-last were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0730|0.8585|
91652557|NCT04147715|183196886|OTHER||Slope|1.028|||||TWO_SIDED|95.0|0.9866|1.0695||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-inf) = Intercept + Slope × ln(Dose) + Random error||1.0695|0.9866|
91709876|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91788157|NCT04620798|183456838|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.10|0.89|
91607500|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.27||0.052|TWO_SIDED|95.0|-1.06|0.0|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-1.06|0.052
91709877|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91709878|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91709879|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91607501|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.44|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.44|-1.50|<0.001
91607502|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.26|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.26|0.006
91607503|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
91607504|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.91|-0.86|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.86|-1.91|<0.001
91607505|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.50|<0.001
91607506|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.27||0.005|TWO_SIDED|95.0|-1.3|-0.23|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.23|-1.30|0.005
91607507|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.75|-0.69|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.69|-1.75|<0.001
91607508|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.061|TWO_SIDED|95.0|-1.07|0.02|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.02|-1.07|0.061
91607509|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.021|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.20|0.021
91607510|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.85|-0.76|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.76|-1.85|<0.001
91607511|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.166|TWO_SIDED|95.0|-0.95|0.16|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.166
91607512|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.167|TWO_SIDED|95.0|-0.95|0.16|||ANOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.167
91607513|NCT00733902|183107531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.75|-0.64|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.64|-1.75|<0.001
91791033|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.454||0.044|TWO_SIDED|95.0|0.023|1.087||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.087|0.023|0.044
91523512|NCT04270747|182922883|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.2|0.8|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||0.8|-3.2|
91607514|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
91607515|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
91607516|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
91607517|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.45|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.51|<0.001
91607518|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.38|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.38|0.002
91607519|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.76|-0.7|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.70|-1.76|<0.001
91709880|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91709881|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91607520|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.35|-0.3|||ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.35|0.002
91607521|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.34|-1.39|0.001
91607522|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.94|-0.9|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.94|<0.001
91652558|NCT04147715|183196886|OTHER||Geometric Least Squares Mean Ratio|0.9646|||||TWO_SIDED|90.0|0.8643|1.0766|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-inf were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0766|0.8643|
91652559|NCT04147715|183196887|OTHER||Geometric Least Squares Mean Ratio|1.0272|||||TWO_SIDED|90.0|0.9949|1.0606|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed t1/2,z as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed t1/2,z were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0606|0.9949|
91652560|NCT04147715|183196894|OTHER||Geometric Least Squares Mean Ratio|1.5167|||||TWO_SIDED|90.0|1.2654|1.818|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8180|1.2654|
91652561|NCT04147715|183196894|OTHER||Geometric Least Squares Mean Ratio|1.8372|||||TWO_SIDED|90.0|1.5696|2.1506|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1506|1.5696|
91652562|NCT04147715|183196894|OTHER||Geometric Least Squares Mean Ratio|1.7489|||||TWO_SIDED|90.0|1.525|2.0057|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0057|1.5250|
91788158|NCT04620798|183456838|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.62|0.50|
91652563|NCT04147715|183196894|OTHER||Geometric Least Squares Mean Ratio|2.1453|||||TWO_SIDED|90.0|1.9741|2.3313|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.3313|1.9741|
91709882|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91791034|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.26|STANDARD_DEVIATION|3.51|||TWO_SIDED|||||||||Week 48||||
91791035|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|0.467||0.195|TWO_SIDED|95.0|-0.312|1.524||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.524|-0.312|0.195
91791036|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|3.53|||TWO_SIDED|||||||||Week 48||||
91607523|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.7|-0.58|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.70|<0.001
91709883|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91709884|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91709885|NCT00524680|183312433|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
91709886|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.8244|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.8244
91791037|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.547||0.778|TWO_SIDED|95.0|-0.921|1.229||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.229|-0.921|0.778
91607524|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.57|-0.45|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.57|<0.001
91652564|NCT04147715|183196896|OTHER||Geometric Least Squares Mean Ratio|1.6277|||||TWO_SIDED|90.0|1.4038|1.8874|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8874|1.4038|
91607525|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.91|-0.79|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.91|<0.001
91607526|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.29||0.021|TWO_SIDED|95.0|-1.26|-0.1|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.26|0.021
91607527|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.29||0.029|TWO_SIDED|95.0|-1.22|-0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.07|-1.22|0.029
91607528|NCT00733902|183107532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.78|-0.62|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.62|-1.78|<0.001
91607529|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
91607530|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
91607531|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
91652565|NCT04147715|183196896|OTHER||Geometric Least Squares Mean Ratio|1.7454|||||TWO_SIDED|90.0|1.4785|2.0605|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0605|1.4785|
91607532|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.46|-0.41|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.46|<0.001
91607533|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||L Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
91607534|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.71|-0.67|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.71|<0.001
91607535|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.33|-0.3|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.33|0.002
91607536|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.46|-0.43|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.46|<0.001
91652566|NCT04147715|183196896|OTHER||Geometric Least Squares Mean Ratio|1.9102|||||TWO_SIDED|90.0|1.7788|2.0513|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0513|1.7788|
91791038|NCT02880956|183460092|OTHER||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.99|||TWO_SIDED|||||||||Week 72||||
91607537|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.04|-1.02|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.04|<0.001
91607538|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.56|-0.51|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.56|<0.001
91607539|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-1.52|<0.001
91791039|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|-0.743|1.376||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.376|-0.743|0.558
91791040|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.89|||TWO_SIDED|||||||||Week 72||||
91652567|NCT04147715|183196896|OTHER||Geometric Least Squares Mean Ratio|2.0478|||||TWO_SIDED|90.0|1.9203|2.1837|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1837|1.9203|
91788159|NCT04620798|183456839|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.06|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.96|
91607540|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.85|-1.90|<0.001
91523513|NCT04270747|182922883|OTHER||Difference between means|-1.5|||||TWO_SIDED|2.0|-3.4|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||0.5|-3.4|
91607541|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.27||0.03|TWO_SIDED|95.0|-1.12|-0.06|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-1.12|0.030
91607542|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
91607543|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.96|-0.9|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.96|<0.001
91607544|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.28||0.085|TWO_SIDED|95.0|-1.03|0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.07|-1.03|0.085
91607545|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.026|TWO_SIDED|95.0|-1.18|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.18|0.026
91607546|NCT00733902|183107533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.94|-0.84|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.84|-1.94|<0.001
91607547|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
91607548|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
91607549|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
91607550|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.63|<0.001
91607551|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
91607552|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
91607553|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
91607554|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.54|<0.001
91709887|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.1025|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.1025
91652568|NCT04147715|183196903|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9241|||||TWO_SIDED|90.0|0.8057|1.06|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0600|0.8057|
91652569|NCT04147715|183196903|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0303|||||TWO_SIDED|90.0|0.9299|1.1415|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.1415|0.9299|
91652570|NCT04147715|183196905|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500|Geometric Least Squares Mean Ratio|0.842|||||TWO_SIDED|90.0|0.6628|1.0696|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0696|0.6628|
91652571|NCT04147715|183196905|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8542|||||TWO_SIDED|90.0|0.7185|1.0155|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0155|0.7185|
91709888|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.1744|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU.||||0.1744
91709889|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.1281|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.1281
91523514|NCT04270747|182922883|OTHER||Difference between means|-1.5|||||TWO_SIDED|90.0|-3.0|0.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||0.0|-3.0|
91709890|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.9688|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.9688
91709891|NCT00524680|183312434|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test.||||<0.0001
91709892|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.8241|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.8241
91709893|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.1828|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1828
91709894|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.1348|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1348
91709895|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.2214|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.2214
91709896|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0079
91709897|NCT00524680|183312434|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0631
91709898|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|10.9|||Mixed Models Analysis|||||10.9|5.0|<0.0001
91709899|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.6|||<|0.0001|TWO_SIDED|95.0|10.2|15.0|||Mixed Models Analysis|||||15.0|10.2|<0.0001
91709900|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||<|0.0001|TWO_SIDED|95.0|11.7|16.2|||Mixed Models Analysis|||||16.2|11.7|<0.0001
91709901|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.3|||<|0.0001|TWO_SIDED|95.0|9.9|14.7|||Mixed Models Analysis|||||14.7|9.9|<0.0001
91652572|NCT04147715|183196906|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8377|||||TWO_SIDED|90.0|0.6645|1.0561|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0561|0.6645|
91652573|NCT04147715|183196906|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8529|||||TWO_SIDED|90.0|0.7213|1.0085|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0085|0.7213|
91652574|NCT02330081|183196958|NON_INFERIORITY|The FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of platelet recovery must be ≥ 66% of fresh control platelet values|Risk Ratio (RR)|83.3|STANDARD_ERROR_OF_MEAN|4.97|||ONE_SIDED|95.0|76.2||||||Estimate is the ratio of the mean platelet recovery of treatment over control||||76.2|
91652575|NCT02330081|183196959|NON_INFERIORITY|One of the FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of the mean platelet survival time must be ≥58% of fresh control platelet mean survival time|Mean Ratio Survival Time|81.0|STANDARD_ERROR_OF_MEAN|2.0|||ONE_SIDED|95.0|77.0||||||Estimate is the ratio of the mean platelet survival time of treatment over control||||77.0|
91652576|NCT02277769|183196972|SUPERIORITY||difference in percentages|27.6|||<|0.0001|TWO_SIDED|95.0|20.46|34.69||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.69|20.46|< 0.0001
91652577|NCT02277769|183196972|SUPERIORITY||difference in percentages|27.9|||<|0.0001|TWO_SIDED|95.0|20.87|34.99||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.99|20.87|< 0.0001
91652578|NCT02277769|183196973|SUPERIORITY||difference in percentages|32.3|||<|0.0001|TWO_SIDED|95.0|24.75|39.94||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||39.94|24.75|< 0.0001
91652579|NCT02277769|183196973|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.69|43.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||43.81|28.69|< 0.0001
91652580|NCT02277769|183196974|SUPERIORITY||difference in percentages|26.5|||<|0.0001|TWO_SIDED|95.0|19.13|33.87||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||33.87|19.13|< 0.0001
91788160|NCT04620798|183456839|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.74|1.31|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.31|0.74|
91652581|NCT02277769|183196974|SUPERIORITY||difference in percentages|29.5|||<|0.0001|TWO_SIDED|95.0|22.11|36.95||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.95|22.11|< 0.0001
91652582|NCT02277769|183196975|SUPERIORITY||difference in percentages|37.8|||<|0.0001|TWO_SIDED|95.0|30.03|45.6||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||45.60|30.03|< 0.0001
91652583|NCT02277769|183196975|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.56|44.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||44.06|28.56|< 0.0001
91709902|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.0014|TWO_SIDED|95.0|-6.9|-1.8|||Mixed Models Analysis|||||-1.8|-6.9|0.0014
91607555|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.85|-0.49|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-0.85|<0.001
91523515|NCT04270747|182922883|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-3.6|-0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||-0.2|-3.6|
91607556|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.63|-0.25|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-0.63|<0.001
91607557|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.19|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.57|<0.001
91607558|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.42|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-0.80|<0.001
91607559|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.035|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-0.42|0.035
91607560|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.125|TWO_SIDED|95.0|-0.36|0.04|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.04|-0.36|0.125
91607561|NCT00733902|183107536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.58|-0.18|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.58|<0.001
91607562|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
91607563|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
91607564|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
91607565|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
91607566|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.62|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.62|<0.001
91607567|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.75|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.75|<0.001
91607568|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
91607569|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.58|<0.001
91607570|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.89|-0.52|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.52|-0.89|<0.001
91607571|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.59|-0.22|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.59|<0.001
91652584|NCT02277769|183196976|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-36.04|-21.83||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.83|-36.04|< 0.0001
91652585|NCT02277769|183196976|SUPERIORITY||Least square (LS) mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-40.2|-25.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.49|-40.20|< 0.0001
91652586|NCT02277769|183196977|SUPERIORITY||difference in percentages|16.3|||<|0.0001|TWO_SIDED|95.0|9.99|22.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.68|9.99|< 0.0001
91709903|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.7601|TWO_SIDED|95.0|-1.5|2.1|||Mixed Models Analysis|||||2.1|-1.5|0.7601
91709904|NCT01096680|183312457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.7||||0.0351|TWO_SIDED|95.0|0.1|3.2|||Mixed Models Analysis|||||3.2|0.1|0.0351
91709905|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1123|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.1123
91709906|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0002|TWO_SIDED|95.0|-1.8|-0.6|||Mixed Models Analysis|||||-0.6|-1.8|0.0002
91607572|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
91709907|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||Mixed Models Analysis|||||-1.0|-2.2|<0.0001
91607573|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.83|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-0.83|<0.001
91607574|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.47|-0.09|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.47|0.004
91607575|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.17|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.55|<0.001
91607576|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.39|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.77|<0.001
91607577|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.09|TWO_SIDED|95.0|-0.37|0.03|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.03|-0.37|0.090
91607578|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.39|0.0|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-0.39|0.053
91607579|NCT00733902|183107537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-0.70|<0.001
91709908|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0947|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.0947
91709909|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9393|TWO_SIDED|95.0|-0.6|0.6|||Mixed Models Analysis|||||0.6|-0.6|0.9393
91709910|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0297|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.0297
91709911|NCT01096680|183312458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||Mixed Models Analysis|||||-0.5|-1.7|0.0004
91709912|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.7758|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||7:50pm||0.6|-0.5|0.7758
91709913|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1798|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||7:50pm||0.9|-0.2|0.1798
91709914|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||7:50pm||0.7|-0.4|0.6090
91709915|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1169|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|||7:50pm||1.0|-0.1|0.1169
91709916|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3028|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||7:50pm||0.3|-0.8|0.3028
91709917|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9831|TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||7:50pm||0.5|-0.5|0.9831
91709918|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2887|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||7:50pm||0.2|-0.8|0.2887
91709919|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4395|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.4395
91709920|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9019|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||8:50pm||0.6|-0.5|0.9019
91709921|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3419|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3419
91709922|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9581|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.9581
91709923|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2572|TWO_SIDED|95.0|-0.9|0.2|||Mixed Models Analysis|||8:50pm||0.2|-0.9|0.2572
91607580|NCT03617926|183107559|SUPERIORITY|In case superiority is not proven, non-inferiority is tested. As non-inferiority margin (δ), a 7.5% worse cure rate is regarded as clinically not relevant. The following null hypothesis will be used: H0, NI: pT-pR \< δ, whereby δ = -7.5%. The lower, 95% confidence interval of the difference pT-pR will be used for the test. If H0, NI will be rejected, non-inferiority cannot be shown.||||||0.023||||||A priori treshold p value of 0.05 for statistical significance was set prior to study start.|Chi-squared|||"Efficacy analyses is performed on the ITT population (all subjects who were included and randomized in the study, with available baseline value of the primary endpoint and at least one follow-up visit). All statistical tests are performed at a 5% level of significance. The aim of this analysis is to show superiority for the cure rate of the test product versus a predefined limit of 70%. The following null hypothesis will be tested: H0, prim: pT - pR = 0 and Ha: pT - pR \> 15%~I"||||0.023
91788161|NCT04620798|183456840|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.09|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.09|0.84|
91788162|NCT04620798|183456840|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.72|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.72|0.33|
91607581|NCT02015819|183107608|OTHER||||||||||||||||||MFD was determined to be 1.5x10\^8 in combination with oral 5-FC 37.5 mg/kg and leucovorin 25 mg every 6 hours for 7 days.|||
91607582|NCT01075087|183107623|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.05|TWO_SIDED|90.0|-26.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|-26|.05
91607583|NCT01486264|183107625|NON_INFERIORITY|Analysis of covariance (ANCOVA) model adjusted for the baseline TWSTRS Severity subscale score, was used to test the non-inferiority of Short Flex versus Long Flex treatment. Non-inferiority margin delta equal to (=) 2 points.|Least Square (LS) Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.9|0.1||||||||0.1|-2.9|
91607584|NCT03584009|183107640|SUPERIORITY||Risk Difference (RD)|-1.96||||0.7286|TWO_SIDED|95.0|-16.86|12.94||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||12.94|-16.86|0.7286
91607585|NCT03584009|183107641|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.7853|TWO_SIDED|95.0|0.61|1.45||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Regression, Cox|||||1.45|0.61|0.7853
91607586|NCT03584009|183107642|SUPERIORITY||Risk Difference (RD)|-1.96||||0.5978|TWO_SIDED|95.0|-12.29|8.37||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||8.37|-12.29|0.5978
91607587|NCT03584009|183107644|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.0403|TWO_SIDED|95.0|1.02|3.43||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Log Rank||Hazard ratios were estimated by Cox regression.|||3.43|1.02|0.0403
91607588|NCT04112914|183107649|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.021|TWO_SIDED||||||Regression, Linear|||||||0.021
91607589|NCT04112914|183107650|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.638|TWO_SIDED||||||Regression, Linear|||||||0.638
91607590|NCT04112914|183107651|SUPERIORITY||Odds Ratio (OR)|1.77||||0.338|TWO_SIDED|95.0|0.55|5.72|||Regression, Logistic|||||5.72|0.55|0.338
91607591|NCT04112914|183107652|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.606|TWO_SIDED||||||Regression, Linear|||||||0.606
91607592|NCT04112914|183107653|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.508|TWO_SIDED||||||Regression, Linear|||||||0.508
91607593|NCT04112914|183107654|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.042|TWO_SIDED||||||Regression, Linear|||||||0.042
91607594|NCT04112914|183107655|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.128|TWO_SIDED||||||Regression, Linear|||||||0.128
91652587|NCT02277769|183196977|SUPERIORITY||difference in percentages|21.3|||<|0.0001|TWO_SIDED|95.0|14.66|27.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||27.93|14.66|< 0.0001
91652588|NCT02277769|183196978|SUPERIORITY||difference in percentages|9.8|||<|0.0001|TWO_SIDED|95.0|5.54|13.98||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13.98|5.54|< 0.0001
91652589|NCT02277769|183196978|SUPERIORITY||difference in percentages|11.8|||<|0.0001|TWO_SIDED|95.0|7.31|16.32||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||16.32|7.31|< 0.0001
91709924|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8085|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.8085
91788163|NCT04620798|183456841|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.74|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.74|
91607595|NCT00768560|183107656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69||||||90.0|-12.62|-6.77|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-6.77|-12.62|
91607596|NCT00768560|183107656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-2.87|2.98|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||2.98|-2.87|
91607597|NCT00768560|183107656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.75||||||90.0|6.83|12.67|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||12.67|6.83|
91607598|NCT00768560|183107656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97||||||90.0|-5.5|-2.44|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-2.44|-5.50|
91607599|NCT00768560|183107656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||90.0|-2.21|0.85|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||0.85|-2.21|
91607600|NCT00768560|183107656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.29||||||90.0|1.76|4.82|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||4.82|1.76|
91607601|NCT00389207|183107666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.016||||0.684||95.0|-0.062|0.095||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)||||0.095|-0.062|0.684
91607602|NCT00389207|183107666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.025||||0.584||95.0|-0.065|0.115||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.115|-0.065|0.584
91607603|NCT00389207|183107666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.009||||0.855||95.0|-0.084|0.101||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||0.101|-0.084|0.855
91607604|NCT00389207|183107667|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.038||||0.321||95.0|-0.112|0.037||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.||||0.037|-0.112|0.321
91607605|NCT00389207|183107678|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.461||||0.0403||95.0|0.22|0.966|||Regression, Cox|||||0.966|0.220|0.0403
91607606|NCT00389207|183107682|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.097||||0.0109||95.0|-0.171|-0.022||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients||||-0.022|-0.171|0.0109
91607607|NCT00389207|183107682|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.072||||0.1033||95.0|-0.158|0.015||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.015|-0.158|0.1033
91607608|NCT00389207|183107682|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.122||||0.0073||95.0|-0.212|-0.033||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.033|-0.212|0.0073
91709925|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3678|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3678
91709926|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3732|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.3732
91709927|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4924|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.4924
91709928|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9798|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.9798
91709929|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8557|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||9:50pm||0.7|-0.6|0.8557
91791041|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.546||0.928|TWO_SIDED|95.0|-1.025|1.124||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.124|-1.025|0.928
91523516|NCT04270747|182922883|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-2.1|1.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.5|-2.1|
91607609|NCT00389207|183107683|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.117||||0.0031||95.0|-0.194|-0.04||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.||||-0.040|-0.194|0.0031
91607610|NCT00389207|183107683|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.096||||0.0365||95.0|-0.186|-0.006||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||-0.006|-0.186|0.0365
91607611|NCT00389207|183107683|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.139||||0.0033||95.0|-0.231|-0.046||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.046|-0.231|0.0033
91607612|NCT00389207|183107686|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.001||||0.9784|TWO_SIDED|95.0|-0.065|0.066|||Cochran Chi-Squared|||week 48||0.066|-0.065|0.9784
91607613|NCT00389207|183107686|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.064||||0.0331|TWO_SIDED|95.0|0.005|0.123|||Cochran Chi-Squared|||week 96||0.123|0.005|0.0331
91607614|NCT00389207|183107686|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.058||||0.0691|TWO_SIDED|95.0|-0.005|0.121|||Cochran Chi-Squared|||week 144||0.121|-0.005|0.0691
91607615|NCT00389207|183107686|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|-0.023||||0.4585|TWO_SIDED|95.0|-0.084|0.038|||Cochran Chi-Squared|||week 48||0.038|-0.084|0.4585
91607616|NCT00389207|183107686|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.015||||0.5438|TWO_SIDED|95.0|-0.034|0.064|||Cochran Chi-Squared|||week 96||0.064|-0.034|0.5438
91607617|NCT00389207|183107686|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.016||||0.5659|TWO_SIDED|95.0|-0.039|0.071|||Cochran Chi-Squared|||week 144||0.071|-0.039|0.5659
91607618|NCT00389207|183107687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0002||95.0|0.57|0.839|||Regression, Cox|||||0.839|0.570|0.0002
91607619|NCT00389207|183107687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001||95.0|0.519|0.764|||Regression, Cox|||Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)||0.764|0.519|<0.0001
91607620|NCT00389207|183107688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.1329||95.0|0.535|1.086|||Regression, Cox|||||1.086|0.535|0.1329
91607621|NCT00389207|183107689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731||||0.0444||95.0|0.539|0.992|||Regression, Cox|||||0.992|0.539|0.0444
91607622|NCT02039947|183107702|SUPERIORITY||Response rate|59.0|||<|0.0001|TWO_SIDED|95.0|47.3|70.4|||percent||Percent|||70.4|47.3|<.0001
91607623|NCT01772134|183107710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||<|0.001|TWO_SIDED|95.0|0.107|0.187|||Mixed Models Analysis|||||0.187|0.107|<0.001
91607624|NCT01772134|183107710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138|||<|0.001|TWO_SIDED|95.0|0.097|0.178|||Mixed Models Analysis|||||0.178|0.097|<0.001
91607625|NCT01740362|183107714|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|137.26|||||TWO_SIDED|90.0|96.77|194.69||||||1 way Analysis of Variance (ANOVA) on natural log-transformed AUC(0-∞) analyzed using linear model with degrees of renal impairment(creatinine clearance\[CLcr, discrete\]) evaluated using blood samples collected at screening as fixed effect. Statistical Analysis System (SAS) mixed procedure (PROC MIXED) was used. Anti-log of adjusted mean difference (CP-690,550\[mild renal insufficiency\] - CP-690,550\[normal renal function\]), 90% confidence interval (CI) were taken to estimate mean ratio and 90% CI.||194.69|96.77|
91607626|NCT01740362|183107714|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|142.59|||||TWO_SIDED|90.0|100.53|202.24||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||202.24|100.53|
91607627|NCT01740362|183107714|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|222.71|||||TWO_SIDED|90.0|157.02|315.89||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||315.89|157.02|
91652590|NCT02277769|183196979|SUPERIORITY||LS mean difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.605|-1.587||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.587|-2.605|< 0.0001
91652591|NCT02277769|183196979|SUPERIORITY||LS mean difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-2.982|-1.957||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.957|-2.982|< 0.0001
91652592|NCT02277769|183196980|SUPERIORITY||LS mean difference|-36.2|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.86|||ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-28.86|-43.46|< 0.0001
91652593|NCT02277769|183196980|SUPERIORITY||LS mean difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-45.55|-30.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.88|-45.55|< 0.0001
91607628|NCT01740362|183107715|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|93.15|||||TWO_SIDED|90.0|67.22|129.06||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[mild renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||129.06|67.22|
91607629|NCT01740362|183107715|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|104.17|||||TWO_SIDED|90.0|75.18|144.34||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||144.34|75.18|
91607630|NCT01740362|183107715|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|117.65|||||TWO_SIDED|95.0|84.91|163.02||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||163.02|84.91|
91607631|NCT00594399|183107721|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of insulin|Mixed Models Analysis|||||||0.43
91607632|NCT00594399|183107724|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of glucose|Mixed Models Analysis|||||||0.91
91607633|NCT00594399|183107727|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus test of difference between groups over time with adjustment for baseline value of physical activity|Mixed Models Analysis|||||||<0.001
91607634|NCT03830281|183107728|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|Mean Difference (Final Values)|0.02||||0.565|TWO_SIDED|95.0|-0.06|0.11|||Mixed Models Analysis|||||0.11|-0.06|0.565
91607635|NCT03830281|183107729|SUPERIORITY||LS Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-36.0|-12.2|||ANCOVA|||||-12.2|-36.0|<0.001
91652594|NCT02277769|183196981|SUPERIORITY||difference in percentages|43.2|||<|0.0001|TWO_SIDED|95.0|35.12|51.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||51.29|35.12|< 0.0001
91652595|NCT02277769|183196981|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|30.92|47.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||47.19|30.92|< 0.0001
91709930|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0998|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|||9:50pm||0.1|-1.2|0.0998
91523517|NCT04270747|182922883|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-1.9|2.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.0|-1.9|
91607636|NCT03830281|183107730|SUPERIORITY||LS Mean Difference|-27.8|||<|0.001|TWO_SIDED|95.0|-42.6|-13.0|||ANCOVA|||||-13.0|-42.6|< 0.001
91607637|NCT03830281|183107731|SUPERIORITY||LS Mean Difference|0.7||||0.532|TWO_SIDED|95.0|-1.4|2.8|||Mixed Models Analysis|||Statistical analysis during daytime is reported.||2.8|-1.4|0.532
91607638|NCT03830281|183107731|SUPERIORITY||LS Mean Difference|0.4||||0.738|TWO_SIDED|95.0|-1.8|2.5|||Mixed Models Analysis|||Statistical analysis during 24-hour period is reported.||2.5|-1.8|0.738
91607639|NCT03133767|183107742|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
91607640|NCT03133767|183107743|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
91607641|NCT03133767|183107744|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
91652596|NCT02277769|183196982|SUPERIORITY||difference in percentages|22.8|||<|0.0001|TWO_SIDED|95.0|16.09|29.59||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||29.59|16.09|< 0.0001
91607642|NCT03133767|183107745|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.361
91607643|NCT03133767|183107746|SUPERIORITY|||||||0.509|||||||Chi-squared|||||||0.509
91607644|NCT00488631|183107771|SUPERIORITY_OR_OTHER|||||||0.01||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.010
91652597|NCT02277769|183196982|SUPERIORITY||difference in percentages|23.3|||<|0.0001|TWO_SIDED|95.0|16.63|30.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||30.05|16.63|< 0.0001
91709931|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1479|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||9:50pm||0.2|-1.1|0.1479
91709932|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8358|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.8358
91709933|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0199|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||10:50pm||-0.1|-1.6|0.0199
91791042|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.27|||TWO_SIDED|||||||||Week 72||||
91652598|NCT02277769|183196983|SUPERIORITY||LS mean difference|-17.99|||<|0.0001|TWO_SIDED|95.0|-22.062|-13.927||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.927|-22.062|< 0.0001
91607645|NCT00488631|183107771|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||<0.001
91607646|NCT00488631|183107772|SUPERIORITY_OR_OTHER|||||||0.122||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.122
91607647|NCT00488631|183107772|SUPERIORITY_OR_OTHER|||||||0.004||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.004
91652599|NCT02277769|183196983|SUPERIORITY||LS mean difference|-19.51|||<|0.0001|TWO_SIDED|95.0|-23.491|-15.529||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.529|-23.491|< 0.0001
91652600|NCT02277769|183196984|SUPERIORITY||LS mean difference|-31.4|||<|0.0001|TWO_SIDED|95.0|-37.36|-25.4||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.40|-37.36|< 0.0001
91652601|NCT02277769|183196984|SUPERIORITY||LS mean difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-39.75|-27.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-27.80|-39.75|< 0.0001
91652602|NCT02277769|183196985|SUPERIORITY||LS mean difference|-5.7|||<|0.0001|TWO_SIDED|95.0|-6.86|-4.47||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.47|-6.86|< 0.0001
91652603|NCT02277769|183196985|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.1|-4.72||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.72|-7.10|< 0.0001
91652604|NCT02277769|183196986|SUPERIORITY||LS mean difference|-7.0|||<|0.0001|TWO_SIDED|95.0|-8.36|-5.57||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.57|-8.36|< 0.0001
91652605|NCT02277769|183196986|SUPERIORITY||LS mean difference|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.36|-6.64||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.64|-9.36|< 0.0001
91652606|NCT02277769|183196987|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.09||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.09|-5.34|< 0.0001
91652607|NCT02277769|183196987|SUPERIORITY||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.04|-3.81||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.81|-6.04|< 0.0001
91652608|NCT02277769|183196988|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.73|-21.7||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.70|-33.73|< 0.0001
91652609|NCT02277769|183196988|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-35.03|-22.74||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.74|-35.03|< 0.0001
91652610|NCT02277769|183196989|SUPERIORITY||LS mean difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-21.96|-13.53||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.53|-21.96|< 0.0001
91607648|NCT00488631|183107773|SUPERIORITY_OR_OTHER|||||||0.011||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.011
91607649|NCT00488631|183107773|SUPERIORITY_OR_OTHER|||||||0.002||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.002
91607650|NCT00488631|183107774|SUPERIORITY_OR_OTHER|||||||0.365||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.365
91607651|NCT00488631|183107774|SUPERIORITY_OR_OTHER|||||||0.098||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.098
91607652|NCT00488631|183107775|SUPERIORITY_OR_OTHER|||||||0.279||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.279
91652611|NCT02277769|183196989|SUPERIORITY||LS mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.16|-10.78||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.78|-19.16|< 0.0001
91652612|NCT02196506|183197014|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0074|TWO_SIDED|95.0|-3.97|-0.62|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.62|-3.97|0.0074
91791043|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.64|STANDARD_ERROR_OF_MEAN|0.541||0.238|TWO_SIDED|95.0|-0.425|1.704||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.704|-0.425|0.238
91652613|NCT02196506|183197015|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.3331|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Analysis|||Statistical Analysis at Week 14||0.23|-0.66|0.3331
91652614|NCT02196506|183197016|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.0263|TWO_SIDED|95.0|-4.23|-0.27|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.27|-4.23|0.0263
91652615|NCT02196506|183197017|SUPERIORITY||Mean Difference (Final Values)|-2.98||||0.0099|TWO_SIDED|95.0|-5.24|-0.72|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.72|-5.24|0.0099
91652616|NCT01070394|183197018|SUPERIORITY_OR_OTHER||||||<|0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.001
91652617|NCT01070394|183197019|SUPERIORITY_OR_OTHER|||||||0.569|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.569
91652618|NCT01070394|183197019|SUPERIORITY_OR_OTHER|||||||0.827|||||||Generalized Estimating Equation|||The following p-value is for AMSES In-Clinic, a subset of the overall AMSES||||.827
91652619|NCT01070394|183197019|SUPERIORITY_OR_OTHER|||||||0.569|||||||Generalized Estimating Equation|||The following p-value is for AMSES, Evening, a subset of the AMSES||||.569
91652620|NCT01070394|183197020|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.001
91652621|NCT01070394|183197021|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||GEE regression model|||||||<.001
91791044|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791045|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.53||0.107|TWO_SIDED|95.0|-0.186|1.898||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.898|-0.186|0.107
91791046|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791047|NCT02880956|183460092|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.548||0.116|TWO_SIDED|95.0|-0.214|1.942||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.942|-0.214|0.116
91791048|NCT02880956|183460092|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791049|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.186||0.683|TWO_SIDED|95.0|-0.442|0.29||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.290|-0.442|0.683
91788164|NCT04620798|183456841|SUPERIORITY||Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.6|3.25|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||3.25|0.60|
91788165|NCT04620798|183456842|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.03|0.99|
91788166|NCT04620798|183456842|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.77|1.21|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.21|0.77|
91788167|NCT04620798|183456843|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.97|1.06|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.97|
91788168|NCT04620798|183456843|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.6|1.11|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.11|0.60|
91788169|NCT04620798|183456844|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.97|
91788170|NCT04620798|183456844|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.12|0.74|
91788171|NCT04620798|183456845|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.71|||||This analysis compares the probability of seroconverting during the study period. The reference group for this analysis was the control (delayed results) group.|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and seroconversion. The reference group for this analysis was the control (delayed results) group.||1.71|0.52|
91788172|NCT03222492|183456858|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
91788173|NCT03222492|183456858|SUPERIORITY|||||||0.444||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.444
91788174|NCT03222492|183456859|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
91788175|NCT03222492|183456859|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.400
91788176|NCT03222492|183456860|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
91788177|NCT03222492|183456860|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
91788178|NCT03222492|183456860|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
91709934|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.7625|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||10:50pm||0.6|-0.9|0.7625
91788179|NCT03222492|183456860|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
91607653|NCT00488631|183107775|SUPERIORITY_OR_OTHER|||||||0.423||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.423
91607654|NCT05300087|183107776|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for Cmax between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.014|||<|0.0001|TWO_SIDED|90.0|0.947|1.085|||ANOVA|||||1.085|0.947|<0.0001
91607655|NCT05300087|183107777|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-t) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.022|||<|0.0001|TWO_SIDED|90.0|0.993|1.051|||ANOVA|||||1.051|0.993|<0.0001
91607656|NCT05300087|183107778|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-inf) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.021|||<|0.0001|TWO_SIDED|90.0|0.994|1.048|||ANOVA|||||1.048|0.994|<0.0001
91607657|NCT03248128|183107783|SUPERIORITY||Least Square Mean Difference|0.083|||<|0.001|TWO_SIDED|95.0|0.037|0.129|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.129|0.037|<0.001
91607658|NCT03248128|183107784|SUPERIORITY||Least Square Mean Difference|3.2||||0.228|TWO_SIDED|95.0|-2.0|8.4|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with covariates of baseline, region, sex, age and treatment.||||8.4|-2.0|0.228
91607659|NCT03248128|183107785|SUPERIORITY||Least Square Mean Difference|6.2||||0.011|TWO_SIDED|95.0|1.4|10.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||10.9|1.4|0.011
91607660|NCT03248128|183107786|SUPERIORITY||Least Square Mean Difference|0.073||||0.002|TWO_SIDED|95.0|0.028|0.118|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.118|0.028|0.002
91607661|NCT03248128|183107787|SUPERIORITY||Least Square Mean Difference|-0.3||||0.87|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||3.8|-4.5|0.870
91788180|NCT03222492|183456860|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
91607662|NCT03248128|183107788|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-4.2|4.1|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||4.1|-4.2|0.988
91607663|NCT03248128|183107789|SUPERIORITY||Least Square Mean Difference|0.035||||0.124|TWO_SIDED|0.95|-0.01|0.08|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.080|-0.010|0.124
91607664|NCT03248128|183107790|SUPERIORITY||Least Square Mean Difference|-0.01||||0.91|TWO_SIDED|95.0|-0.1|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.10|0.910
91607665|NCT03248128|183107791|SUPERIORITY||Least Square Mean Difference|1.3||||0.614|TWO_SIDED|95.0|-3.6|6.2|||ANCOVA|Analysis performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.2|-3.6|0.614
91607666|NCT03248128|183107792|SUPERIORITY||Least Square Mean Difference|1.3||||0.594|TWO_SIDED|95.0|-3.6|6.3|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.3|-3.6|0.594
91607667|NCT03248128|183107793|SUPERIORITY||Least Square Mean Difference|0.028||||0.226|TWO_SIDED|95.0|-0.017|0.073|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.073|-0.017|0.226
91652622|NCT01070394|183197022|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.0001
91652623|NCT01070394|183197023|SUPERIORITY_OR_OTHER|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||0.001
91652624|NCT04014959|183197123|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -4.47||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
91652625|NCT04014959|183197123|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -3.00||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
91652626|NCT04014959|183197123|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -2.96||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
91788181|NCT03222492|183456860|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.500
91709935|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1936|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.1936
91788182|NCT03222492|183456861|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
91788183|NCT03222492|183456861|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
91607668|NCT03248128|183107794|SUPERIORITY||Least Square Mean Difference|-0.02||||0.663|TWO_SIDED|95.0|-0.13|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.13|0.663
91607669|NCT00741819|183107813|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.0|STANDARD_DEVIATION|35.9|<|0.001||95.0|||||Wilcoxon signed rank test]||Change in 6MWD from Baseline was calculated for patients still remaining on study at Week 12.|Analysis of endpoints was descriptive in nature. Numeric endpoints for post-baseline assessments were compared to Baseline using Wilcoxon signed rank test, and p-values were calculated for descriptive purposes; no formal hypothesis testing was planned.||||<0.001
91607670|NCT00741819|183107814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|7.7|<|0.001|||||||Wilcoxon signed rank test||Analysis based on Total CAMPHOR Score.|||||<0.001
91607671|NCT00741819|183107815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|21.3||0.895||95.0|||||Wilcoxon signed-rank test||Side-Effects Score, change from Baseline to Week 12|||||0.895
91607672|NCT00741819|183107815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.3|STANDARD_DEVIATION|25.9|<|0.001||95.0|||||Wilcoxon signed-rank test||Convenience Score, change from Baseline to Week 12|||||<0.001
91607673|NCT00741819|183107815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|23.7|<|0.001||95.0|||||Wilcoxon signed-rank test||Global Satisfaction, change from Baseline to Week 12|||||<0.001
91607674|NCT00741819|183107815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.9|STANDARD_DEVIATION|21.5|<|0.001||95.0|||||Wilcoxon signed rank test||Effectiveness score, change from Baseline to Week 12|||||<0.001
91607675|NCT00741819|183107817|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
91607676|NCT01126580|183107820|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.36|-0.08||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of 1.5 mg LY2189265 vs Metformin on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 2-sided alpha of 0.05 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 11%.||-0.08|-0.36|<0.001
91607677|NCT01126580|183107820|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.15|||<|0.001|TWO_SIDED|95.0|-0.29|-0.01||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.01|-0.29|<0.001
91607678|NCT01126580|183107820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.002|TWO_SIDED|95.0|-0.36|-0.08||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.08|-0.36|0.002
91607679|NCT01126580|183107820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.01||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.01|-0.29|0.020
91607680|NCT01126580|183107821|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.35|-0.02||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.02|-0.35|<0.001
91607681|NCT01126580|183107821|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.04|||<|0.001|TWO_SIDED|95.0|-0.2|0.12||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||0.12|-0.20|<0.001
91607682|NCT01126580|183107821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.024|TWO_SIDED|95.0|-0.35|-0.02||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.02|-0.35|0.024
91607683|NCT01126580|183107821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.299|TWO_SIDED|95.0|-0.2|0.12||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||0.12|-0.20|0.299
91607684|NCT01126580|183107822|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.023
91607685|NCT01126580|183107822|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.021
91607686|NCT01126580|183107822|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||<0.001
91607687|NCT01126580|183107822|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.011
91607688|NCT01126580|183107822|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.001
91709936|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.4534|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||10:50pm||1.0|-0.5|0.4534
91709937|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0012|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||10:50pm||-0.5|-2.0|0.0012
91709938|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.2072|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.2072
91607689|NCT01126580|183107822|SUPERIORITY_OR_OTHER|||||||0.269||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.269
91607690|NCT01126580|183107822|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||<0.001
91607691|NCT01126580|183107822|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.134
91607692|NCT01126580|183107823|SUPERIORITY_OR_OTHER|||||||0.079||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.079
91607693|NCT01126580|183107823|SUPERIORITY_OR_OTHER|||||||0.451||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.451
91607694|NCT01126580|183107823|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.025
91607695|NCT01126580|183107823|SUPERIORITY_OR_OTHER|||||||0.402||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.402
91607696|NCT01126580|183107824|SUPERIORITY_OR_OTHER|||||||0.061||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.061
91607697|NCT01126580|183107824|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.647
91607698|NCT01126580|183107824|SUPERIORITY_OR_OTHER|||||||0.022||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.022
91607699|NCT01126580|183107824|SUPERIORITY_OR_OTHER|||||||0.469||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.469
91607700|NCT01126580|183107825|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.811
91607701|NCT01126580|183107825|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
91607702|NCT01126580|183107825|SUPERIORITY_OR_OTHER|||||||0.44||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.440
91652627|NCT04014959|183197123|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -5.05||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
91652628|NCT04014959|183197125|OTHER|Statistics are an unadjusted linear regression of change in DASS-21 depression score on the pre-intervention TMS/fMRI evoked brain response.||||||0.007|||||||Regression, Linear|β = -33.60||Analysis to investigate the correlation between changes in DASS-21 Scores (Secondary Outcome) and Evoked Functional Brain Activity (Other Pre-specified Outcome) pre and post the 3-Day TMS Intervention Regimen.||||0.007
91652629|NCT02004847|183197130|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.||||0.0005
91652630|NCT02004847|183197131|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.||||0.0036
91607703|NCT01126580|183107825|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
91607704|NCT01126580|183107826|SUPERIORITY_OR_OTHER|||||||0.75||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.750
91607705|NCT01126580|183107826|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
91607706|NCT01126580|183107826|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.412
91607707|NCT01126580|183107826|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
91607708|NCT01126580|183107827|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
91607709|NCT01126580|183107827|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
91607710|NCT01126580|183107827|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||<0.001
91607711|NCT01126580|183107827|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||0.003
91607712|NCT01126580|183107827|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.001
91607713|NCT01126580|183107827|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.010
91607714|NCT01126580|183107827|SUPERIORITY_OR_OTHER|||||||0.077||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.077
91607715|NCT01126580|183107827|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.004
91607716|NCT03040154|183107850|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.33|5.35|||Regression, Logistic|||||5.35|1.33|0.006
91607717|NCT02382133|183107852|SUPERIORITY|comparing nasal and forehead oximetry sensor pressure ulcer incidence|||||=|0.006|||||||Chi-squared|||||||=.006
91607718|NCT04321343|183107854|SUPERIORITY||Mean Difference (Final Values)|-25.313|STANDARD_ERROR_OF_MEAN|9.587||0.0083|TWO_SIDED|95.0|-44.1036|-6.5227|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.5227|-44.1036|0.0083
91607719|NCT04321343|183107854|SUPERIORITY||Mean Difference (Final Values)|-21.003|STANDARD_ERROR_OF_MEAN|9.287||0.0237|TWO_SIDED|95.0|-39.2074|-2.7991|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-2.7991|-39.2074|0.0237
91607720|NCT04321343|183107854|SUPERIORITY||Mean Difference (Final Values)|-23.748|STANDARD_ERROR_OF_MEAN|9.053||0.0087|TWO_SIDED|95.0|-41.4923|-6.0035|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.0035|-41.4923|0.0087
91652631|NCT02004847|183197132|SUPERIORITY_OR_OTHER|||||||0.3075|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.||||0.3075
91709939|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0413|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||10:50pm||0.0|-1.5|0.0413
91788184|NCT03222492|183456862|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
91788185|NCT03222492|183456862|SUPERIORITY|||||||0.467||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.467
91523518|NCT04270747|182922883|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-4.0|0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.2|-4.0|
91607721|NCT04321343|183107855|SUPERIORITY||Hodges-Lehmann midpoint estimate|-26.226|STANDARD_ERROR_OF_MEAN|10.252||0.0105|TWO_SIDED|95.0|-46.3208|-6.1313|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-6.1313|-46.3208|0.0105
91607722|NCT04321343|183107855|SUPERIORITY||Hodges-Lehmann midpoint estimate|-21.496|STANDARD_ERROR_OF_MEAN|9.873||0.0295|TWO_SIDED|95.0|-40.8475|-2.1451|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-2.1451|-40.8475|0.0295
91607723|NCT04321343|183107855|SUPERIORITY||Hodges-Lehmann midpoint estimate|-24.29|STANDARD_ERROR_OF_MEAN|9.746||0.0127|TWO_SIDED|95.0|-43.392|-5.1884|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-5.1884|-43.3920|0.0127
91607724|NCT04321343|183107856|SUPERIORITY||Mean Difference (Final Values)|-4.671|STANDARD_ERROR_OF_MEAN|1.824||0.0105|TWO_SIDED|95.0|-8.2463|-1.0957|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0957|-8.2463|0.0105
91607725|NCT04321343|183107856|SUPERIORITY||Mean Difference (Final Values)|-4.097|STANDARD_ERROR_OF_MEAN|1.743||0.0188|TWO_SIDED|95.0|-7.514|-0.6799|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-0.6799|-7.5140|0.0188
91607726|NCT04321343|183107856|SUPERIORITY||Mean Difference (Final Values)|-4.321|STANDARD_ERROR_OF_MEAN|1.689||0.0105|TWO_SIDED|95.0|-7.6307|-1.0104|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0104|-7.6307|0.0105
91607727|NCT04321343|183107857|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1634|TWO_SIDED|95.0|0.677|10.087|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||10.087|0.677|0.1634
91607728|NCT04321343|183107857|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0722|TWO_SIDED|95.0|0.899|11.831|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.831|0.899|0.0722
91652632|NCT02004847|183197133|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.||||0.0140
91652633|NCT02004847|183197133|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.||||0.0064
91652634|NCT02004847|183197133|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.||||0.1020
91652635|NCT02220920|183197146|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.33|-0.87|||ANCOVA|||||-0.87|-1.33|<0.001
91652636|NCT02220920|183197147|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.001|TWO_SIDED|95.0|-46.3|-18.9|||ANCOVA|||||-18.9|-46.3|<0.001
91788186|NCT03222492|183456863|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
91788187|NCT03222492|183456863|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.400
91788188|NCT03222492|183456864|SUPERIORITY|||||||0.464||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.464
91607729|NCT04321343|183107857|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0703|TWO_SIDED|95.0|0.909|11.052|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.052|0.909|0.0703
91607730|NCT04321343|183107858|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|8.2||0.4318|TWO_SIDED|95.0|-22.66|9.72|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||9.72|-22.66|0.4318
91652637|NCT02220920|183197148|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.09|-1.65|||ANCOVA|||||-1.65|-3.09|<0.001
91652638|NCT02220920|183197149|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-3.19|STANDARD_ERROR_OF_MEAN|1.67||0.058|TWO_SIDED|95.0|-6.49|0.11|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.|||0.11|-6.49|0.058
91652639|NCT02220920|183197149|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|1.03||0.232|TWO_SIDED|95.0|-3.27|0.8|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.|||0.80|-3.27|0.232
91652640|NCT00789802|183197154|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.03
91652641|NCT00789802|183197154|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.02
91788189|NCT03222492|183456864|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.500
91607731|NCT04321343|183107858|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|8.0||0.8382|TWO_SIDED|95.0|-17.37|14.1|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.10|-17.37|0.8382
91607732|NCT04321343|183107858|SUPERIORITY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.7||0.4982|TWO_SIDED|95.0|-9.92|20.33|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||20.33|-9.92|0.4982
91607733|NCT04321343|183107859|SUPERIORITY||Odds Ratio (OR)|0.72||||0.7137|TWO_SIDED|95.0|0.131|3.935|||Cochran-Mantel-Haenszel|||||3.935|0.131|0.7137
91607734|NCT04321343|183107859|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0597|TWO_SIDED|95.0|0.937|14.58|||Cochran-Mantel-Haenszel|||||14.580|0.937|0.0597
91607735|NCT04321343|183107859|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1749|TWO_SIDED|95.0|0.655|10.43|||Cochran-Mantel-Haenszel|||||10.430|0.655|0.1749
91607736|NCT04321343|183107860|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|8.8||0.7449|TWO_SIDED|95.0|-20.15|14.43|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.43|-20.15|0.7449
91607737|NCT04321343|183107860|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|8.6||0.7255|TWO_SIDED|95.0|-19.93|13.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||13.90|-19.93|0.7255
91607738|NCT04321343|183107860|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|8.2||0.7755|TWO_SIDED|95.0|-13.89|18.59|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||18.59|-13.89|0.7755
91607739|NCT04321343|183107861|SUPERIORITY||Odds Ratio (OR)|3.12||||0.1325|TWO_SIDED|95.0|0.703|13.806|||Cochran-Mantel-Haenszel|||||13.806|0.703|0.1325
91607740|NCT04321343|183107861|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9918|TWO_SIDED|95.0|0.201|4.898|||Cochran-Mantel-Haenszel|||||4.898|0.201|0.9918
91607741|NCT04321343|183107861|SUPERIORITY||Odds Ratio (OR)|4.78||||0.041|TWO_SIDED|95.0|1.053|21.714|||Cochran-Mantel-Haenszel|||||21.714|1.053|0.0410
91607742|NCT04321343|183107862|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|10.3||0.4413|TWO_SIDED|95.0|-28.25|12.36|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||12.36|-28.25|0.4413
91607743|NCT04321343|183107862|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.2||0.0859|TWO_SIDED|95.0|-37.63|2.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.50|-37.63|0.0859
91607744|NCT04321343|183107862|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.0||0.7887|TWO_SIDED|95.0|-22.31|16.97|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||16.97|-22.31|0.7887
91607745|NCT04321343|183107863|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.7||0.1166|TWO_SIDED|95.0|-13.19|1.47|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.47|-13.19|0.1166
91607746|NCT04321343|183107863|SUPERIORITY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|3.7||0.003|TWO_SIDED|95.0|-18.26|-3.8|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-3.80|-18.26|0.0030
91607747|NCT04321343|183107863|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|3.5||0.0131|TWO_SIDED|95.0|-15.79|-1.87|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.87|-15.79|0.0131
91607748|NCT04321343|183107864|SUPERIORITY||Mean Difference (Final Values)|-1.013|STANDARD_ERROR_OF_MEAN|1.481||0.4963|TWO_SIDED|95.0|-3.9701|1.9436|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.9436|-3.9701|0.4963
91607749|NCT04321343|183107864|SUPERIORITY||Mean Difference (Final Values)|-0.712|STANDARD_ERROR_OF_MEAN|1.402||0.6131|TWO_SIDED|95.0|-3.5109|2.0866|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||2.0866|-3.5109|0.6131
91607750|NCT04321343|183107864|SUPERIORITY||Mean Difference (Final Values)|-1.441|STANDARD_ERROR_OF_MEAN|1.362||0.2939|TWO_SIDED|95.0|-4.1593|1.2779|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.2779|-4.1593|0.2939
91607751|NCT04321343|183107865|SUPERIORITY||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.211||0.7672|TWO_SIDED|95.0|-0.4845|0.3589|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3589|-0.4845|0.7672
91607752|NCT04321343|183107865|SUPERIORITY||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.198||0.5233|TWO_SIDED|95.0|-0.5216|0.2678|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2678|-0.5216|0.5233
91788190|NCT03222492|183456864|SUPERIORITY|||||||0.25||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.250
91788191|NCT03222492|183456864|SUPERIORITY|||||||0.167||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.167
91788192|NCT03222492|183456864|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.083
91607753|NCT04321343|183107865|SUPERIORITY||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.18||0.1263|TWO_SIDED|95.0|-0.6376|0.0805|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0805|-0.6376|0.1263
91788193|NCT03222492|183456864|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.083
91788194|NCT03222492|183456865|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
91788195|NCT03222492|183456865|SUPERIORITY|||||||0.429||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.429
91788196|NCT03222492|183456866|SUPERIORITY|||||||0.286||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.286
91788197|NCT03222492|183456866|SUPERIORITY|||||||0.067||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.067
91788198|NCT03222492|183456867|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.100
91607754|NCT04321343|183107866|SUPERIORITY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.165||0.8662|TWO_SIDED|95.0|-0.3559|0.3002|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3002|-0.3559|0.8662
91607755|NCT04321343|183107866|SUPERIORITY||Mean Difference (Final Values)|-0.094|STANDARD_ERROR_OF_MEAN|0.166||0.5726|TWO_SIDED|95.0|-0.4253|0.2369|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2369|-0.4253|0.5726
91607756|NCT04321343|183107866|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.153||0.2289|TWO_SIDED|95.0|-0.4907|0.1192|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.1192|-0.4907|0.2289
91607757|NCT04321343|183107867|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.254||0.8595|TWO_SIDED|95.0|-0.5509|0.4607|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4607|-0.5509|0.8595
91607758|NCT04321343|183107867|SUPERIORITY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.25||0.3776|TWO_SIDED|95.0|-0.7194|0.2759|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2759|-0.7194|0.3776
91607759|NCT04321343|183107867|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.232||0.0424|TWO_SIDED|95.0|-0.9426|0.017|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0170|-0.9426|0.0424
91607760|NCT04321343|183107868|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1084|TWO_SIDED|95.0|0.775|14.152|||Cochran-Mantel-Haenszel|||||14.152|0.775|0.1084
91607761|NCT04321343|183107868|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
91607762|NCT04321343|183107868|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3333|TWO_SIDED|95.0|0.501|6.948|||Cochran-Mantel-Haenszel|||||6.948|0.501|0.3333
91607763|NCT04321343|183107869|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7677|TWO_SIDED|95.0|0.345|4.23|||Cochran-Mantel-Haenszel|||||4.230|0.345|0.7677
91607764|NCT04321343|183107869|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
91607765|NCT04321343|183107869|SUPERIORITY||Odds Ratio (OR)|1.97||||0.2711|TWO_SIDED|95.0|0.598|6.486|||Cochran-Mantel-Haenszel|||||6.486|0.598|0.2711
91607766|NCT04321343|183107870|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5981|TWO_SIDED|95.0|0.376|5.547|||Cochran-Mantel-Haenszel|||||5.547|0.376|0.5981
91607767|NCT04321343|183107870|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6228|TWO_SIDED|95.0|0.363|5.572|||Cochran-Mantel-Haenszel|||||5.572|0.363|0.6228
91607768|NCT04321343|183107870|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8799|TWO_SIDED|95.0|0.245|3.323|||Cochran-Mantel-Haenszel|||||3.323|0.245|0.8799
91607769|NCT04321343|183107871|SUPERIORITY||Odds Ratio (OR)|3.28||||0.1474|TWO_SIDED|95.0|0.625|17.208|||Cochran-Mantel-Haenszel|||||17.208|0.625|0.1474
91607770|NCT04321343|183107871|SUPERIORITY||Odds Ratio (OR)|2.65||||0.262|TWO_SIDED|95.0|0.481|14.631|||Cochran-Mantel-Haenszel|||||14.631|0.481|0.2620
91607771|NCT04321343|183107871|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6935|TWO_SIDED|95.0|0.117|4.133|||Cochran-Mantel-Haenszel|||||4.133|0.117|0.6935
91607772|NCT04321343|183107872|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6384|TWO_SIDED|95.0|-0.35|0.215|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.215|-0.350|0.6384
91607773|NCT04321343|183107872|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.0549|TWO_SIDED|95.0|-0.547|0.006|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.006|-0.547|0.0549
91607774|NCT04321343|183107872|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.683|-0.142|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.142|-0.683|0.0030
91607775|NCT04321343|183107873|SUPERIORITY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.389||0.8961|TWO_SIDED|95.0|-0.8165|0.7149|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7149|-0.8165|0.8961
91607776|NCT04321343|183107873|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.384||0.671|TWO_SIDED|95.0|-0.5935|0.9204|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.9204|-0.5935|0.6710
91607777|NCT04321343|183107873|SUPERIORITY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.364||0.9846|TWO_SIDED|95.0|-0.7092|0.7233|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7233|-0.7092|0.9846
91607778|NCT04321343|183107874|SUPERIORITY||Mean Difference (Final Values)|-84.93|STANDARD_ERROR_OF_MEAN|36.75||0.0216|TWO_SIDED|95.0|-157.306|-12.558|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-12.558|-157.306|0.0216
91607779|NCT04321343|183107874|SUPERIORITY||Mean Difference (Final Values)|-46.61|STANDARD_ERROR_OF_MEAN|35.72||0.1931|TWO_SIDED|95.0|-116.957|23.738|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||23.738|-116.957|0.1931
91652642|NCT02811861|183197158|SUPERIORITY||Stratified Hazard Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.8|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.80|0.53|<0.0001
91709940|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1086|TWO_SIDED|95.0|-1.5|0.1|||Mixed Models Analysis|||11:50pm||0.1|-1.5|0.1086
91652643|NCT02811861|183197158|SUPERIORITY||Stratified Hazard Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.32|0.49|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.49|0.32|<0.0001
91652644|NCT04081337|183197174|SUPERIORITY||LS Mean Difference|19.68||||0.5733|TWO_SIDED|95.0|-50.36|89.72|||ANCOVA|||||89.72|-50.36|0.5733
91652645|NCT04081337|183197175|SUPERIORITY||LS Mean Difference|-855.94|||<|0.0001|TWO_SIDED|95.0|-1090.87|-621.02|||ANCOVA|||||-621.02|-1090.87|<0.0001
91652646|NCT04081337|183197176|SUPERIORITY||LS Mean Difference|-3.22||||0.9481|TWO_SIDED|95.0|-102.65|96.2|||ANCOVA|||||96.20|-102.65|0.9481
91652647|NCT04081337|183197177|SUPERIORITY||LS Mean Difference|-0.034|||<|0.0001|TWO_SIDED|95.0|-0.051|-0.018|||ANCOVA|||||-0.018|-0.051|<0.0001
91652648|NCT04081337|183197178|SUPERIORITY||LS Mean difference|-0.028||||0.0031|TWO_SIDED|95.0|-0.045|-0.01|||ANCOVA|||||-0.010|-0.045|0.0031
91652649|NCT04081337|183197179|SUPERIORITY||LS Mean difference|251.89||||0.0004|TWO_SIDED|95.0|119.09|384.69|||ANCOVA|||||384.69|119.09|0.0004
91709941|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.5843|TWO_SIDED|95.0|-1.0|0.6|||Mixed Models Analysis|||11:50pm||0.6|-1.0|0.5843
91788199|NCT03222492|183456868|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.100
91788200|NCT03222492|183456879|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
91788201|NCT03222492|183456879|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
91652650|NCT04081337|183197180|SUPERIORITY||LS Mean difference|-6.87||||0.0005|TWO_SIDED|95.0|-10.51|-3.22|||ANCOVA|||For Adjusted protein oxidation||-3.22|-10.51|0.0005
91652651|NCT04081337|183197180|SUPERIORITY||LS Mean difference|14.48|||<|0.0001|TWO_SIDED|95.0|8.02|20.93|||ANCOVA|||For Adjusted fat oxidation||20.93|8.02|<0.0001
91652652|NCT04081337|183197180|SUPERIORITY||LS Mean difference|-26.64||||0.0001|TWO_SIDED|95.0|-39.46|-13.83|||ANCOVA|||Adjusted carbohydrate oxidation||-13.83|-39.46|0.0001
91652653|NCT04081337|183197181|SUPERIORITY||LS Mean difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-11.04|-5.9|||Mixed Models Analysis|||||-5.90|-11.04|<0.0001
91652654|NCT04081337|183197182|SUPERIORITY||LS Mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.12|-3.05|||Mixed Models Analysis|||||-3.05|-5.12|<0.0001
91652655|NCT04081337|183197183|SUPERIORITY||LS Mean difference|-5.08|||<|0.0001|TWO_SIDED|95.0|-6.93|-3.22|||ANCOVA|||||-3.22|-6.93|<0.0001
91652656|NCT04081337|183197184|SUPERIORITY||LS Mean Difference|-1.14||||0.0304|TWO_SIDED|95.0|-2.16|-0.11|||ANCOVA|||||-0.11|-2.16|0.0304
91652657|NCT04081337|183197185|SUPERIORITY||LS Mean difference|-1.83|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.06|||ANCOVA|||For Triglyceride||-1.06|-2.60|<0.0001
91652658|NCT04081337|183197185|SUPERIORITY||LS Mean difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||For VLDL||-0.48|-1.19|<0.0001
91652659|NCT04081337|183197185|SUPERIORITY||LS Mean difference|-0.53||||0.0436|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||For HDL||-0.02|-1.05|0.0436
91652660|NCT04081337|183197185|SUPERIORITY||LS Mean Difference|0.45||||0.0002|TWO_SIDED|95.0|0.23|0.66|||ANCOVA|||For Free fatty acid||0.66|0.23|0.0002
91652661|NCT04081337|183197186|SUPERIORITY||LS Mean Difference|0.03||||0.8762|TWO_SIDED|95.0|-0.34|0.4|||ANCOVA|||||0.40|-0.34|0.8762
91652662|NCT04081337|183197187|SUPERIORITY||LS Mean difference|3.49||||0.0126|TWO_SIDED|95.0|0.79|6.19|||ANCOVA|||||6.19|0.79|0.0126
91652663|NCT04081337|183197188|SUPERIORITY||LS Mean Difference|-1.26||||0.0222|TWO_SIDED|95.0|-2.34|-0.19|||ANCOVA|||||-0.19|-2.34|0.0222
91652664|NCT04081337|183197189|SUPERIORITY||LS Mean difference|-0.36|||<|0.0001|TWO_SIDED|95.0|-0.48|-0.23|||ANCOVA|||||-0.23|-0.48|<0.0001
91652665|NCT06624072|183197190|OTHER||Ratio of adjusted geometric means (T1/R)|103.23|||||TWO_SIDED|90.0|97.31|109.52|||||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 8.7%.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale.||109.52|97.31|
91652666|NCT06624072|183197191|OTHER||Ratio of adjusted geometric means, T2/T1|95.56|||||TWO_SIDED|90.0|89.37|102.18|||||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 10.3%.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale.||102.18|89.37|
91709942|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0571|TWO_SIDED|95.0|-1.6|0.0|||Mixed Models Analysis|||11:50pm||0.0|-1.6|0.0571
91709943|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3965|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||11:50pm||0.5|-1.2|0.3965
91709944|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0009|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||11:50pm||-0.6|-2.2|0.0009
91709945|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0211|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||11:50pm||-0.1|-1.8|0.0211
91709946|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.2863|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||11:50pm||0.4|-1.2|0.2863
91709947|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0428|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||12:50am||0.0|-1.7|0.0428
91607780|NCT04321343|183107874|SUPERIORITY||Mean Difference (Final Values)|-63.4|STANDARD_ERROR_OF_MEAN|33.31||0.0581|TWO_SIDED|95.0|-129.002|2.194|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.194|-129.002|0.0581
91709948|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3757|TWO_SIDED|95.0|-0.5|1.2|||Mixed Models Analysis|||12:50am||1.2|-0.5|0.3757
91607781|NCT04321343|183107875|SUPERIORITY||Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.153||0.0958|TWO_SIDED|95.0|-0.5577|0.0456|||Mixed Models Analysis|Mixed Models Analysis|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0456|-0.5577|0.0958
91607782|NCT04321343|183107875|SUPERIORITY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.148||0.0659|TWO_SIDED|95.0|-0.5648|0.0181|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0181|-0.5648|0.0659
91607783|NCT04321343|183107875|SUPERIORITY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.138||0.0297|TWO_SIDED|95.0|-0.5728|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0300|-0.5728|0.0297
91607784|NCT04321343|183107876|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.175||0.2606|TWO_SIDED|95.0|-0.5423|0.1476|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1476|-0.5423|0.2606
91788202|NCT03222492|183456880|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||||||1.000
91607785|NCT04321343|183107876|SUPERIORITY||Mean Difference (Final Values)|-0.234|STANDARD_ERROR_OF_MEAN|0.17||0.1709|TWO_SIDED|95.0|-0.569|0.1016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1016|-0.5690|0.1709
91607786|NCT04321343|183107876|SUPERIORITY||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.155||0.04|TWO_SIDED|95.0|-0.6274|-0.0148|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0148|-0.6274|0.0400
91607787|NCT04321343|183107877|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3955|TWO_SIDED|95.0|-0.0139|0.0351|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0351|-0.0139|0.3955
91607788|NCT04321343|183107877|SUPERIORITY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3081|TWO_SIDED|95.0|-0.0115|0.0362|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0362|-0.0115|0.3081
91607789|NCT04321343|183107877|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.011||0.1374|TWO_SIDED|95.0|-0.0053|0.0383|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0383|-0.0053|0.1374
91607790|NCT04321343|183107878|SUPERIORITY||Mean Difference (Final Values)|-48.94|STANDARD_ERROR_OF_MEAN|20.86||0.0199|TWO_SIDED|95.0|-90.073|-7.817|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-7.817|-90.073|0.0199
91607791|NCT04321343|183107878|SUPERIORITY||Mean Difference (Final Values)|-29.77|STANDARD_ERROR_OF_MEAN|18.66||0.112|TWO_SIDED|95.0|-66.558|7.009|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.009|-66.558|0.1120
91607792|NCT04321343|183107878|SUPERIORITY||Mean Difference (Final Values)|-54.64|STANDARD_ERROR_OF_MEAN|17.9||0.0026|TWO_SIDED|95.0|-89.935|-19.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-19.340|-89.935|0.0026
91607793|NCT04321343|183107879|SUPERIORITY||Mean Difference (Final Values)|1.674|STANDARD_ERROR_OF_MEAN|0.896||0.0639|TWO_SIDED|95.0|-0.098|3.447|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.4470|-0.0980|0.0639
91788203|NCT03222492|183456880|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
91788204|NCT01054183|183456881|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.57||95.0|||||z test, two-sided|||Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groups||||0.57
91607794|NCT04321343|183107879|SUPERIORITY||Mean Difference (Final Values)|2.831|STANDARD_ERROR_OF_MEAN|0.867||0.0014|TWO_SIDED|95.0|1.1149|4.5464|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.5464|1.1149|0.0014
91607795|NCT04321343|183107879|SUPERIORITY||Mean Difference (Final Values)|4.876|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|3.1982|6.5543|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.5543|3.1982|<0.0001
91607796|NCT04321343|183107880|SUPERIORITY||Mean Difference (Final Values)|1.183|STANDARD_ERROR_OF_MEAN|0.909||0.1944|TWO_SIDED|95.0|-0.608|2.9748|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.9748|-0.6080|0.1944
91709949|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0002|TWO_SIDED|95.0|-2.4|-0.8|||Mixed Models Analysis|||12:50am||-0.8|-2.4|0.0002
91709950|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.3535|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||12:50am||0.4|-1.2|0.3535
91709951|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.1|||Mixed Models Analysis|||12:50am||-1.1|-2.7|<0.0001
91709952|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1131|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||12:50am||0.2|-1.5|0.1131
91607797|NCT04321343|183107880|SUPERIORITY||Mean Difference (Final Values)|2.459|STANDARD_ERROR_OF_MEAN|0.879||0.0056|TWO_SIDED|95.0|0.7268|4.1907|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.1907|0.7268|0.0056
91709953|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0039|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|||12:50am||-0.4|-2.0|0.0039
91607798|NCT04321343|183107880|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.858||0.4288|TWO_SIDED|95.0|-1.0111|2.372|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.3720|-1.0111|0.4288
91607799|NCT04321343|183107881|SUPERIORITY||Mean Difference (Final Values)|-1.251|STANDARD_ERROR_OF_MEAN|1.093||0.2564|TWO_SIDED|95.0|-3.4307|0.9295|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.9295|-3.4307|0.2564
91607800|NCT04321343|183107881|SUPERIORITY||Mean Difference (Final Values)|-1.598|STANDARD_ERROR_OF_MEAN|1.021||0.1222|TWO_SIDED|95.0|-3.6348|0.4392|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4392|-3.6348|0.1222
91607801|NCT04321343|183107881|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.936||0.0206|TWO_SIDED|95.0|-4.088|-0.351|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||-0.3510|-4.0880|0.0206
91607802|NCT04321343|183107882|SUPERIORITY||Odds Ratio (OR)|1.51||||0.5221|TWO_SIDED|95.0|0.436|5.201|||Cochran-Mantel-Haenszel|||||5.201|0.436|0.5221
91607803|NCT04321343|183107882|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
91607804|NCT04321343|183107882|SUPERIORITY||Odds Ratio (OR)|2.87||||0.0914|TWO_SIDED|95.0|0.853|9.636|||Cochran-Mantel-Haenszel|||||9.636|0.853|0.0914
91607805|NCT04321343|183107883|SUPERIORITY||Odds Ratio (OR)|2.71||||0.1854|TWO_SIDED|95.0|0.628|11.679|||Cochran-Mantel-Haenszel|||||11.679|0.628|0.1854
91607806|NCT04321343|183107883|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
91607807|NCT04321343|183107883|SUPERIORITY||Odds Ratio (OR)|1.53||||0.5223|TWO_SIDED|95.0|0.398|5.88|||Cochran-Mantel-Haenszel|||||5.880|0.398|0.5223
91607808|NCT04321343|183107884|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.891||0.7532|TWO_SIDED|95.0|-1.4749|2.0356|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.0356|-1.4749|0.7532
91607809|NCT04321343|183107884|SUPERIORITY||Mean Difference (Final Values)|1.985|STANDARD_ERROR_OF_MEAN|0.858||0.0216|TWO_SIDED|95.0|0.2946|3.6763|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.6763|0.2946|0.0216
91607810|NCT04321343|183107884|SUPERIORITY||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.838||0.7893|TWO_SIDED|95.0|-1.4283|1.8771|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.8771|-1.4283|0.7893
91607811|NCT03430310|183107885|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91652667|NCT06624072|183197192|OTHER||Ratio of adjusted geometric means, T1/R|104.34|||||TWO_SIDED|90.0|91.0|119.65|||||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 20.4%.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale.||119.65|91.00|
91709954|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1302|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||1:50am||0.2|-1.5|0.1302
91607812|NCT03972488|183107886|SUPERIORITY||Hazard Ratio (HR)|0.276|||<|0.0001|TWO_SIDED|95.0|0.182|0.418|||Log Rank|Stratified one-sided P-value||||0.418|0.182|<0.0001
91607813|NCT03972488|183107887|SUPERIORITY||Stratified Odds Ratio|7.81|||<|0.0001|TWO_SIDED|95.0|3.32|18.4|||Stratified One-sided p-value|||||18.40|3.32|<0.0001
91607814|NCT03972488|183107888|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.2222|TWO_SIDED|95.0|0.57|1.283|||Log Rank|Stratified one-sided P-value||Global Health Status||1.283|0.570|0.2222
91607815|NCT02770807|183107894|SUPERIORITY||Least squares mean difference|-1.37||||0.0847|TWO_SIDED|95.0|-2.932|0.19|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.190|-2.932|0.0847
91709955|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.6138|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|||1:50am||1.1|-0.6|0.6138
91709956|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.0008|TWO_SIDED|95.0|-2.3|-0.6|||Mixed Models Analysis|||1:50am||-0.6|-2.3|0.0008
91709957|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.1643|TWO_SIDED|95.0|-1.5|0.3|||Mixed Models Analysis|||1:50am||0.3|-1.5|0.1643
91709958|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0002|TWO_SIDED|95.0|-2.5|-0.8|||Mixed Models Analysis|||1:50am||-0.8|-2.5|0.0002
91709959|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0782|TWO_SIDED|95.0|-1.6|0.1|||Mixed Models Analysis|||1:50am||0.1|-1.6|0.0782
91709960|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0441|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||1:50am||0.0|-1.7|0.0441
91709961|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0193|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0193
91709962|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7071|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||2:50am||0.8|-1.2|0.7071
91709963|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0002|TWO_SIDED|95.0|-2.9|-0.9|||Mixed Models Analysis|||2:50am||-0.9|-2.9|0.0002
91788205|NCT01054183|183456882|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.002||95.0|||||z test, two-sided|||Null hypothesis: overall successful intubation rate is the same for both groups.||||0.002
91788206|NCT02486627|183456883|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|-3.4|||||TWO_SIDED|95.0|-10.0|3.1||||||||3.1|-10|
91788207|NCT02486627|183456884|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|11.6|||||TWO_SIDED|95.0|2.7|20.3||||||||20.3|2.7|
91788208|NCT02189954|183456893|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91709964|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0611|TWO_SIDED|95.0|-1.9|0.0|||Mixed Models Analysis|||2:50am||0.0|-1.9|0.0611
91788209|NCT02189954|183456893|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mann Whitney U|||||||<0.05
91788210|NCT02112045|183456897|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
91788211|NCT02112045|183456898|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
91788212|NCT03554486|183456909|OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
91788213|NCT03554486|183456910|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91788214|NCT03554486|183456911|OTHER|||||||0.74|||||||t-test, 2 sided|||||||0.74
91788215|NCT02270944|183456928|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.79|1.32|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.32|0.79|
91788216|NCT02270944|183456929|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.76|1.3|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes III when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.30|0.76|
91791050|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791051|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.184||0.973|TWO_SIDED|95.0|-0.356|0.368||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.368|-0.356|0.973
91607816|NCT02770807|183107894|SUPERIORITY||Least squares mean difference|-1.4||||0.0765|TWO_SIDED|95.0|-2.957|0.152|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.152|-2.957|0.0765
91607817|NCT02770807|183107895|SUPERIORITY||Odds Ratio (OR)|0.946||||0.8919|TWO_SIDED|95.0|0.426|2.099|||Regression, Logistic|||Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region as fixed effects.||2.099|0.426|0.8919
91607818|NCT02770807|183107895|SUPERIORITY||Odds Ratio (OR)|1.848||||0.1255|TWO_SIDED|95.0|0.842|4.053|||Regression, Logistic|||"Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels:~\<10 years, ≥10 years), sex, treatment, region as fixed effects."||4.053|0.842|0.1255
91607819|NCT02770807|183107896|SUPERIORITY||Odds Ratio (OR)|1.369||||0.4583|TWO_SIDED|95.0|0.597|3.144|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.144|0.597|0.4583
91709965|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||2:50am||-1.2|-3.2|<0.0001
91709966|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0160
91709967|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.048|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||2:50am||0.0|-2.0|0.0480
91709968|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0234|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||3:50am||-0.2|-2.2|0.0234
91709969|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.5624|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|||3:50am||0.7|-1.3|0.5624
91709970|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||3:50am||-1.5|-3.5|<0.0001
91709971|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||3:50am||-0.6|-2.6|0.0022
91709972|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.6|||Mixed Models Analysis|||3:50am||-1.6|-3.7|<0.0001
91709973|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0008|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||3:50am||-0.8|-2.8|0.0008
91607820|NCT02770807|183107896|SUPERIORITY||Odds Ratio (OR)|1.371||||0.4585|TWO_SIDED|95.0|0.595|3.16|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.160|0.595|0.4585
91607821|NCT02770807|183107897|SUPERIORITY||Least squares means difference|-13.33||||0.7029|TWO_SIDED|95.0|-82.261|55.601|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||55.601|-82.261|0.7029
91607822|NCT02770807|183107897|SUPERIORITY||Least squares means difference|-77.31||||0.0328|TWO_SIDED|95.0|-148.201|-6.421|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||-6.421|-148.201|0.0328
91607823|NCT01167712|183107902|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.74|1.06||||||Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.||1.06|.74|
91607824|NCT01167712|183107903|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.72|1.23||||||||1.23|.72|
91607825|NCT00914628|183108001|SUPERIORITY|||||||0.8974|||||||Log Rank|||||||0.8974
91607826|NCT00914628|183108001|SUPERIORITY|||||||0.7612|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population- from baseline to day 21||||0.7612
91607827|NCT00914628|183108001|SUPERIORITY|||||||0.5995|||||||Log Rank|||||||0.5995
91607828|NCT00914628|183108001|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population - day 21 after transplant||||0.4078
91652668|NCT06624072|183197193|OTHER||Ratio of adjusted geometric means, T2/T1|68.71|||||TWO_SIDED|90.0|61.23|77.11|||||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 17.9%.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale.||77.11|61.23|
91788217|NCT02270944|183456930|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.72|1.22|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.22|0.72|
91709974|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0883|TWO_SIDED|95.0|-1.9|0.1|||Mixed Models Analysis|||3:50am||0.1|-1.9|0.0883
91788218|NCT01375075|183456948|SUPERIORITY_OR_OTHER||LS Mean Difference|92.61|STANDARD_ERROR_OF_MEAN|9.04|<|0.001|TWO_SIDED|90.0|77.65|107.57||The P-value is for percent change from baseline in HDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||107.57|77.65|<0.001
91607829|NCT00914628|183108001|SUPERIORITY|||||||0.3351|||||||Log Rank|||DFS- Per-Protocol Set||||0.3351
91607830|NCT00914628|183108001|SUPERIORITY|||||||0.1233|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set||||0.1233
91607831|NCT00914628|183108001|EQUIVALENCE|||||||0.5995|||||||Log Rank|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.5995
91607832|NCT00914628|183108001|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.4078
91607833|NCT00914628|183108002|SUPERIORITY|||||||0.766|||||||Log Rank|Statistical analysis was performed on Intention-To-Treat population.||||||0.7660
91607834|NCT00914628|183108002|SUPERIORITY|||||||0.6706|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Intention-To-Treat population.||||0.6706
91607835|NCT00914628|183108002|SUPERIORITY|||||||0.7332|||||||Log Rank|||Statistical analysis has been performed for Per-Protocol Set)||||0.7332
91607836|NCT00914628|183108002|SUPERIORITY|||||||0.6439|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Per-Protocol Set)||||0.6439
91607837|NCT00914628|183108003|SUPERIORITY|||||||0.1735|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.1735
91607838|NCT00914628|183108003|SUPERIORITY|||||||0.5958|||||||Chi-squared|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.5958
91607839|NCT00914628|183108003|SUPERIORITY|||||||0.2889|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2889
91607840|NCT00914628|183108003|SUPERIORITY|||||||0.1642|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for Per-Protocol Set.||||0.1642
91607841|NCT00914628|183108003|SUPERIORITY|||||||0.8739|||||||Log Rank|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.8739
91607842|NCT00914628|183108003|SUPERIORITY|||||||0.2304|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2304
91607843|NCT00914628|183108008|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This Statistical Analysis refers to ITT Patients with relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.3526
91709975|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3093|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||4:50am||0.5|-1.5|0.3093
91607844|NCT00914628|183108008|SUPERIORITY|||||||0.4035|||||||Chi-squared|||this Gray's Statistical Analysis refers to ITT Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.4035
91788219|NCT01375075|183456948|SUPERIORITY_OR_OTHER||LS Mean Difference|106.17|STANDARD_ERROR_OF_MEAN|10.69|<|0.001|TWO_SIDED|90.0|88.47|123.87||The P-value is for percent change from baseline in HDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||123.87|88.47|<0.001
91607845|NCT00914628|183108008|SUPERIORITY|||||||0.2607|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS patients with relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.2607
91607846|NCT00914628|183108008|SUPERIORITY|||||||0.5929|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Function||||0.5929
91607847|NCT00914628|183108012|SUPERIORITY|||||||0.4035|||||||Chi-squared|||This Statistical Analysis refers to ITT Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.4035
91607848|NCT00914628|183108012|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.3526
91607849|NCT00914628|183108012|SUPERIORITY|||||||0.5929|||||||Chi-squared|||This Statistical Analysis refers to PPS Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.5929
91607850|NCT00914628|183108012|SUPERIORITY|||||||0.2607|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.2607
91607851|NCT01756157|183108013|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.61||||0.0523|TWO_SIDED|95.0|-1.23|0.01|||Paired t-test, 2 sided|||||0.01|-1.23|0.0523
91607852|NCT02799381|183108023|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-15.05|||<|0.0001|TWO_SIDED|95.0|-21.47|-8.63||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|||-8.63|-21.47|<0.0001
91607853|NCT02799381|183108024|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|1.71|4.83||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||4.83|1.71|<0.0001
91607854|NCT02799381|183108025|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-16.66|||<|0.0001|TWO_SIDED|95.0|-24.48|-8.85||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-8.85|-24.48|<0.0001
91607855|NCT02799381|183108026|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.11|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.44|-2.78|<0.0001
91607856|NCT02799381|183108027|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-5.54|||=|0.0006|TWO_SIDED|95.0|-8.59|-2.49||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-2.49|-8.59|=0.0006
91709976|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8871|TWO_SIDED|95.0|-0.9|1.1|||Mixed Models Analysis|||4:50am||1.1|-0.9|0.8871
91788220|NCT01375075|183456948|SUPERIORITY_OR_OTHER||LS Mean Difference|103.66|STANDARD_ERROR_OF_MEAN|11.18|<|0.001|TWO_SIDED|90.0|85.14|122.17||The P-value is for percent change from baseline in HDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||122.17|85.14|<0.001
91791052|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91607857|NCT02799381|183108028|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.35|||=|0.0002|TWO_SIDED|95.0|-3.51|-1.19||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.19|-3.51|=0.0002
91607858|NCT02799381|183108029|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-4.05|||=|0.0762|TWO_SIDED|95.0|-8.55|0.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||0.44|-8.55|=0.0762
91607859|NCT02698410|183108034|OTHER|||||||0.2968||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Comparison of DCR to 30% clinically relevant threshold.||||0.2968
91607860|NCT02698410|183108034|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
91607861|NCT02698410|183108034|OTHER|||||||0.0534||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 30% clinically relevant threshold.||||0.0534
91607862|NCT02698410|183108034|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
91607863|NCT02698410|183108034|OTHER|||||||0.032||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 30% clinically relevant threshold.||||0.032
91607864|NCT02698410|183108034|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
91607865|NCT03952130|183108050|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07|||||TWO_SIDED|95.0|-0.11|0.24||||||||0.24|-0.11|
91607866|NCT03952130|183108051|SUPERIORITY||LS Mean Difference|-17.8||||0.003|TWO_SIDED|95.0|-29.4|-6.1|||ANCOVA|||||-6.1|-29.4|0.003
91607867|NCT03952130|183108052|SUPERIORITY||LS Mean Difference|-25.5||||0.001|TWO_SIDED|95.0|-41.1|-10.0|||ANCOVA|||||-10.0|-41.1|0.001
91607868|NCT03952130|183108053|OTHER||Relative rate|0.85||||0.834|TWO_SIDED|95.0|0.19|3.77|||Empirical method|||||3.77|0.19|0.834
91607869|NCT03952130|183108054|OTHER||Relative rate|1.0||||0.983|TWO_SIDED|95.0|0.72|1.38|||Negative binomial regression|||\<=30 minutes post meal||1.38|0.72|0.983
91652669|NCT06624072|183197194|OTHER||Ratio of adjusted geometric means, T1/R|103.06|||||TWO_SIDED|90.0|97.22|109.25|||||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 8.6%.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale.||109.25|97.22|
91652670|NCT06624072|183197195|OTHER||Ratio of adjusted geometric means, T2/T1|95.73|||||TWO_SIDED|90.0|89.47|102.42|||||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 10.4%.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale.||102.42|89.47|
91652671|NCT00449072|183197219|SUPERIORITY_OR_OTHER||Difference (LS Mean)|-0.45||||0.0096|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|The treatment arm, age group (at Visit 1) and sex were fixed effects, and baseline growth velocity was a covariate in the ANCOVA model||||-0.11|-0.78|0.0096
91652672|NCT00449072|183197220|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.7341|TWO_SIDED|95.0|-0.83|0.58|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|||0.58|-0.83|0.7341
91652673|NCT00449072|183197221|SUPERIORITY_OR_OTHER||LS Mean Differerence|-0.15||||0.1963|TWO_SIDED|95.0|-0.37|0.08|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in nasal stuffiness||0.08|-0.37|0.1963
91652674|NCT00449072|183197221|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7193|TWO_SIDED|95.0|-0.24|0.17|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Discharge||0.17|-0.24|0.7193
91652675|NCT00449072|183197221|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.402|TWO_SIDED|95.0|-0.12|0.29|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Sneezing||0.29|-0.12|0.4020
91709977|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||4:50am||-1.2|-3.2|<0.0001
91709978|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||4:50am||-0.6|-2.6|0.0022
91788221|NCT01375075|183456948|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.46|STANDARD_ERROR_OF_MEAN|4.39|<|0.001|TWO_SIDED|90.0|-24.73|-10.19||The P-value is for percent change from baseline in LDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-10.19|-24.73|<0.001
91788222|NCT01375075|183456948|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.39|STANDARD_ERROR_OF_MEAN|4.4||0.019|TWO_SIDED|90.0|-17.67|-3.11||The P-value is for percent change from baseline in LDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-3.11|-17.67|0.019
91607870|NCT03952130|183108054|OTHER||Relative rate|1.61||||0.076|TWO_SIDED|95.0|0.95|2.74|||Negative binomial regression|||\<=1 hour post meal||2.74|0.95|0.076
91607871|NCT03952130|183108054|OTHER||Relative rate|1.19||||0.409|TWO_SIDED|95.0|0.79|1.79|||Negative binomial regression|||\<=2 hours post meal||1.79|0.79|0.409
91607872|NCT03952130|183108054|OTHER||Relative rate|1.22||||0.217|TWO_SIDED|95.0|0.89|1.68|||Negative binomial regression|||\<=4 hours post meal||1.68|0.89|0.217
91607873|NCT03952130|183108054|OTHER||Relative rate|1.09||||0.703|TWO_SIDED|95.0|0.71|1.65|||Negative binomial regression|||\>1 to \<=2 hours post meal||1.65|0.71|0.703
91607874|NCT03952130|183108054|OTHER||Relative rate|1.24||||0.206|TWO_SIDED|95.0|0.89|1.73|||Negative binomial regression|||\>2 to \<=4 hours post meal||1.73|0.89|0.206
91607875|NCT03952130|183108054|OTHER||Relative rate|0.75||||0.082|TWO_SIDED|95.0|0.55|1.04|||Negative binomial regression|||\>4 hours post meal||1.04|0.55|0.082
91607876|NCT03952130|183108055|OTHER||LS Mean Difference|-0.29||||0.309|TWO_SIDED|95.0|-0.86|0.27|||Mixed Models Analysis|||||0.27|-0.86|0.309
91607877|NCT03952130|183108056|OTHER||LS Mean Difference|-15.7|||<|0.001|TWO_SIDED|95.0|-23.8|-7.7|||Mixed Models Analysis|||Morning premeal-fasting||-7.7|-23.8|<.001
91607878|NCT03952130|183108056|OTHER||LS Mean Difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Morning 1-hour post meal||-4.2|-23.8|0.005
91607879|NCT03952130|183108056|OTHER||LS Mean Difference|-14.9||||0.004|TWO_SIDED|95.0|-25.0|-4.8|||Mixed Models Analysis|||Morning 2-hour post meal||-4.8|-25.0|0.004
91607880|NCT03952130|183108056|OTHER||LS Mean Difference|-2.3||||0.616|TWO_SIDED|95.0|-11.4|6.8|||Mixed Models Analysis|||Midday premeal||6.8|-11.4|0.616
91607881|NCT03952130|183108056|OTHER||LS Mean Difference|-9.1||||0.054|TWO_SIDED|95.0|-18.4|0.1|||Mixed Models Analysis|||Midday 1-hour post meal||0.1|-18.4|0.054
91607882|NCT03952130|183108056|OTHER||LS Mean Difference|-3.3||||0.483|TWO_SIDED|95.0|-12.6|6.0|||Mixed Models Analysis|||Midday 2-hour post meal||6.0|-12.6|0.483
91607883|NCT03952130|183108056|OTHER||LS Mean Difference|10.5||||0.064|TWO_SIDED|95.0|-0.6|21.7|||Mixed Models Analysis|||Evening premeal||21.7|-0.6|0.064
91607884|NCT03952130|183108056|OTHER||LS Mean Difference|-5.6||||0.262|TWO_SIDED|95.0|-15.5|4.2|||Mixed Models Analysis|||Evening 1-hour post meal||4.2|-15.5|0.262
91607885|NCT03952130|183108056|OTHER||LS Mean Difference|-7.8||||0.117|TWO_SIDED|95.0|-17.5|2.0|||Mixed Models Analysis|||Evening 2-hour post meal||2.0|-17.5|0.117
91607886|NCT03952130|183108056|OTHER||LS Mean Difference|-4.4||||0.414|TWO_SIDED|95.0|-15.1|6.2|||Mixed Models Analysis|||Bedtime||6.2|-15.1|0.414
91607887|NCT03952130|183108057|OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||Basal insulin dose||0.6|-0.7|0.947
91607888|NCT03952130|183108057|OTHER||LS Mean Difference|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Analysis|||Bolus insulin dose||2.6|-1.3|0.500
91607889|NCT03952130|183108057|OTHER||LS Mean Difference|0.6||||0.543|TWO_SIDED|95.0|-1.4|2.7|||Mixed Models Analysis|||Total insulin dose||2.7|-1.4|0.543
91607890|NCT03952130|183108058|OTHER||Odds Ratio (OR)|0.81||||0.462|TWO_SIDED|95.0|0.47|1.42|||Regression, Logistic|||For HbA1c \< 7%||1.42|0.47|0.462
91607891|NCT03952130|183108058|OTHER||Odds Ratio (OR)|0.54||||0.089|TWO_SIDED|95.0|0.26|1.1|||Regression, Logistic|||For HbA1c ≤6.5%||1.10|0.26|0.089
91607892|NCT01713348|183108059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|3.3||0.9345|TWO_SIDED|95.0|-1.29|1.19|||t-test, 2 sided|||||1.19|-1.29|0.9345
91607893|NCT01713348|183108059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.5||0.0427|TWO_SIDED|95.0|0.05|2.73|||t-test, 2 sided|||Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.||2.73|0.05|0.0427
91607894|NCT01713348|183108060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|1.18||0.8367|TWO_SIDED|95.0|-2.65|2.16|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.16|-2.65|0.8367
91607895|NCT01713348|183108060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_DEVIATION|1.05||0.7969|TWO_SIDED|95.0|-1.86|2.4|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.40|-1.86|0.7969
91607896|NCT01713348|183108061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.6||0.0352|TWO_SIDED|95.0|-0.51|-0.02|||t-test, 2 sided|||||-0.02|-0.51|0.0352
91607897|NCT01713348|183108061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.7||0.0506|TWO_SIDED|95.0|-0.54|0.0|||t-test, 2 sided|||||0.00|-0.54|0.0506
91607898|NCT01713348|183108062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.0||0.058|TWO_SIDED|95.0|-6.4|0.1|||t-test, 2 sided|||||0.1|-6.4|0.0580
91709979|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.4|||Mixed Models Analysis|||4:50am||-1.4|-3.4|<0.0001
91709980|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0006|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||4:50am||-0.8|-2.8|0.0006
91709981|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2462|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||4:50am||0.4|-1.6|0.2462
91791053|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.189||0.921|TWO_SIDED|95.0|-0.389|0.352||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.352|-0.389|0.921
91652676|NCT00449072|183197221|SUPERIORITY_OR_OTHER||LS mean Difference|-0.02||||0.8854|TWO_SIDED|95.0|-0.23|0.2|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Itching||0.20|-0.23|0.8854
91652677|NCT00449072|183197222|SUPERIORITY_OR_OTHER|||||||0.0951||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.0951
91652678|NCT00449072|183197222|SUPERIORITY_OR_OTHER|||||||0.1247||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 240||||0.1247
91709982|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.4427|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||5:50am||0.6|-1.4|0.4427
91709983|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.4405|TWO_SIDED|95.0|-0.6|1.4|||Mixed Models Analysis|||5:50am||1.4|-0.6|0.4405
91607899|NCT01713348|183108062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|12.0||0.0002|TWO_SIDED|95.0|-13.6|-4.9|||t-test, 2 sided|||||-4.9|-13.6|0.0002
91607900|NCT01713348|183108063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.8||0.058|TWO_SIDED|95.0|-0.59|0.01|||t-test, 2 sided|||||0.01|-0.59|0.0580
91607901|NCT01713348|183108063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.1||0.0002|TWO_SIDED|95.0|-1.24|-0.45|||t-test, 2 sided|||||-0.45|-1.24|0.0002
91607902|NCT04425850|183108076|OTHER||||||<|0.0001|||||||Chi-squared|||Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm||||< 0.0001
91607903|NCT03199911|183108078|SUPERIORITY||Risk Ratio (RR)|0.0||||0.025|TWO_SIDED||||||Fisher Exact|||||||0.025
91607904|NCT03199911|183108080|SUPERIORITY||Risk Ratio (RR)|1.3||||0.77|TWO_SIDED|95.0|0.42|4.03|||Fisher Exact|||||4.03|0.42|0.77
91607905|NCT03199911|183108081|SUPERIORITY||Risk Ratio (RR)|0.93||||1|TWO_SIDED|95.0|0.06|14.77|||Fisher Exact|||||14.77|0.06|1.00
91652679|NCT00449072|183197222|SUPERIORITY_OR_OTHER|||||||0.0207||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 360||||0.0207
91788223|NCT01375075|183456948|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.26|STANDARD_ERROR_OF_MEAN|4.77||0.011|TWO_SIDED|90.0|-20.17|-4.36||The P-value is for percent change from baseline in LDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-4.36|-20.17|0.011
91607906|NCT04331899|183108082|OTHER||Cox Proportional Hazard|0.81||||0.29|TWO_SIDED|95.0|0.56|1.19||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.19|0.56|0.29
91607907|NCT04331899|183108083|OTHER||Cox Proportional Hazard|-0.06||||0.91|TWO_SIDED|95.0|-1.23|1.11||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Log change at Day 14. Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.11|-1.23|0.91
91607908|NCT04331899|183108084|OTHER||Cox Proportional Hazard|1.01||||0.95|TWO_SIDED|95.0|0.85|1.16||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.16|0.85|0.95
91607909|NCT04331899|183108085|OTHER||Cox Proportional Hazard|0.94||||0.76|TWO_SIDED|95.0|0.6|1.41||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.41|0.60|0.76
91607910|NCT00101361|183108087|NON_INFERIORITY_OR_EQUIVALENCE|the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.|Mean Difference (Final Values)|-5.7|||<|0.05|TWO_SIDED|95.0|-17.5|6.8|||Cochran-Mantel-Haenszel|||For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.||6.8|-17.5|<0.05
91652680|NCT00449072|183197223|SUPERIORITY_OR_OTHER|||||||0.2445||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.2445
91652681|NCT00449072|183197223|SUPERIORITY_OR_OTHER|||||||0.4488||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 240||||0.4488
91709984|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0003|TWO_SIDED|95.0|-3.0|-0.9|||Mixed Models Analysis|||5:50am||-0.9|-3.0|0.0003
91709985|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0279|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||5:50am||-0.1|-2.2|0.0279
91709986|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||5:50am||-1.5|-3.5|<0.0001
91709987|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0015|TWO_SIDED|95.0|-2.7|-0.7|||Mixed Models Analysis|||5:50am||-0.7|-2.7|0.0015
91709988|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1246|TWO_SIDED|95.0|-1.8|0.2|||Mixed Models Analysis|||5:50am||0.2|-1.8|0.1246
91709989|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3067|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||6:50am||0.5|-1.6|0.3067
91788224|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|2.5||0.136|TWO_SIDED|90.0|-0.39|7.88||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||7.88|-0.39|0.136
91788225|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|2.48||0.257|TWO_SIDED|90.0|-1.28|6.94||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||6.94|-1.28|0.257
91788226|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.54||0.021|TWO_SIDED|90.0|1.7|10.1||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||10.10|1.70|0.021
91607911|NCT01062399|183108088|OTHER||||||||||||||||||A dose level for RAD001 will be considered acceptable if no patient of the first 3patients or no more than 2 patients of the first 6 patients experience a DLT. If the current level is considered acceptable, then dose escalation will occur and the protocol will be reopened. Otherwise, the preceding acceptable dose level will be declared the MTD.|||
91607912|NCT01062399|183108089|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.79|TWO_SIDED|95.0|0.82|1.6|||Log Rank||Reference arm = RT + TMZ|Assuming exponential distribution with median PFS (mPFS) time for control of 6.7 mos. for the control arm, tt was hypothesized that there would be a 43% improvement in mPFS time, corresponding to a mPFS time of 9.6. This is equivalent to a hazard ratio of 0.7 for the experimental arm vs. control arm. With a 1-sided significance level = 0.15 and 85% power, a total of 134 PFS events out of 180 eligible patients were required to detect the projected effect size.||1.60|0.82|0.79
91607913|NCT01062399|183108090|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.008|TWO_SIDED|95.0|1.14|2.45|||Log Rank|2-sided significance level = 0.05|Reference level = RT + TMZ|||2.45|1.14|0.008
91607914|NCT02424539|183108093|OTHER||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.68|-0.78|||ANCOVA||Least square (LS) mean difference between placebo and FF 55 µg QD has been presented using analysis of co-variance (ANCOVA) model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.78|-1.68|<0.001
91607915|NCT02424539|183108093|OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.77|-0.87|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.87|-1.77|<0.001
91607916|NCT02424539|183108094|OTHER||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.14|0.39|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.39|0.14|<0.001
91607917|NCT02424539|183108094|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.33|0.12|<0.001
91607918|NCT02424539|183108095|OTHER||Mean Difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.84|-1.46|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.46|-2.84|<0.001
91607919|NCT02424539|183108095|OTHER||Mean Difference (Final Values)|-1.98|||<|0.001|TWO_SIDED|95.0|-2.66|-1.29|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.29|-2.66|<0.001
91607920|NCT02424539|183108096|OTHER||Mean Difference (Final Values)|-0.1||||0.503|TWO_SIDED|95.0|-0.38|0.18|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.18|-0.38|0.503
91607921|NCT02424539|183108096|OTHER||Mean Difference (Final Values)|-0.25||||0.078|TWO_SIDED|95.0|-0.53|0.03|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.03|-0.53|0.078
91607922|NCT02424539|183108097|OTHER||Mean Difference (Final Values)|0.51||||0.048|TWO_SIDED|95.0|0.01|1.02|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.02|0.01|0.048
91607923|NCT02424539|183108097|OTHER||Mean Difference (Final Values)|0.66||||0.011|TWO_SIDED|95.0|0.16|1.17|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.17|0.16|0.011
91607924|NCT02424539|183108098|OTHER||Mean Difference (Final Values)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.83|-0.9|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.90|-1.83|<0.001
91607925|NCT02424539|183108098|OTHER||Mean Difference (Final Values)|-1.46|||<|0.001|TWO_SIDED|95.0|-1.92|-0.99|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.99|-1.92|<0.001
91607926|NCT02424539|183108099|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.34|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.34|0.12|<0.001
91652682|NCT00449072|183197223|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.|Mixed model for repeated measures|||Statistical Analysis for Day 360||||0.0142
91709990|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.894|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|||6:50am||1.1|-1.0|0.8940
91709991|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0034|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||6:50am||-0.5|-2.7|0.0034
91709992|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0708|TWO_SIDED|95.0|-2.0|0.1|||Mixed Models Analysis|||6:50am||0.1|-2.0|0.0708
91709993|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||6:50am||-1.4|-3.6|<0.0001
91709994|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0006|TWO_SIDED|95.0|-2.9|-0.8|||Mixed Models Analysis|||6:50am||-0.8|-2.9|0.0006
91788227|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|2.52||0.829|TWO_SIDED|90.0|-4.71|3.62||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.62|-4.71|0.829
91607927|NCT02424539|183108099|OTHER||Odds Ratio (OR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.29|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.29|0.10|<0.001
91607928|NCT02424539|183108100|OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-3.23|-1.73|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.73|-3.23|<0.001
91607929|NCT02424539|183108100|OTHER||Mean Difference (Final Values)|-2.27|||<|0.001|TWO_SIDED|95.0|-3.03|-1.52|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.52|-3.03|<0.001
91607930|NCT02424539|183108101|OTHER||Mean Difference (Final Values)|-0.11||||0.442|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.17|-0.38|0.442
91607931|NCT02424539|183108101|OTHER||Mean Difference (Final Values)|-0.3||||0.035|TWO_SIDED|95.0|-0.57|-0.02|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.02|-0.57|0.035
91607932|NCT02424539|183108102|OTHER||Mean Difference (Final Values)|1.88||||0.004|TWO_SIDED|95.0|0.6|3.16|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.16|0.60|0.004
91607933|NCT02424539|183108102|OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.38|3.95|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.95|1.38|<0.001
91607934|NCT01882725|183108178|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91607935|NCT01882725|183108179|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91607936|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 1||||< 0.0001
91607937|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 2||||< 0.0001
91607938|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 3||||< 0.0001
91607939|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 4||||< 0.0001
91607940|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 5||||< 0.0001
91607941|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 6||||< 0.0001
91607942|NCT00500071|183108180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 7||||< 0.0001
91607943|NCT00500071|183108181|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
91607944|NCT00500071|183108184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
91607945|NCT00500071|183108185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Global Executive Composite||||< 0.0001
91607946|NCT00500071|183108185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Behavioral Recognition Index||||< 0.0001
91607947|NCT00500071|183108185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Metacognition Index||||< 0.0001
91607948|NCT04898166|183108192|SUPERIORITY|||||||0|||||||Chi-squared|Chi-square value 18.90 and its asymptotic significance .000||||||0.000
91607949|NCT04898166|183108193|SUPERIORITY|||||||0.081|||||||Chi-squared|Chi-square value 7.544 and its asymptotic significance .273||||||0.081
91607950|NCT02115308|183108296|SUPERIORITY|||||||0.001|||||||paired, t-test|non-adjusted||REST-TO-REGADENOSON STRESS||||0.001
91709995|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2476|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||6:50am||0.4|-1.7|0.2476
91607951|NCT02115308|183108296|SUPERIORITY|||||||0.017||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.017
91607952|NCT02115308|183108296|SUPERIORITY|||||||0.495||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.495
91607953|NCT02115308|183108296|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|non-adjusted||REST||||0.365
91607954|NCT02115308|183108296|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|non adjusted||REST||||0.602
91607955|NCT02115308|183108296|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|non adjusted||REST||||0.915
91607956|NCT02115308|183108296|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.033
91607957|NCT02115308|183108296|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
91607958|NCT02115308|183108296|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.087
91607959|NCT02115308|183108296|SUPERIORITY|||||||0.399|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS CHANGE||||0.399
91607960|NCT02115308|183108296|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.030
91607961|NCT02115308|183108296|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.048
91607962|NCT02115308|183108297|SUPERIORITY|||||||0.011||||||Non-adjusted.|paired, t-test|||Rest VS Regadenoson Stress||||0.011
91607963|NCT02115308|183108297|SUPERIORITY|||||||0.003||||||non-adjusted|paired t-test|||Rest VS Regadenoson Stress||||0.003
91607964|NCT02115308|183108297|SUPERIORITY|non-adjusted||||||0.39|||||||paired, t-test|||Rest VS Regadenoson Stress||||0.390
91607965|NCT02115308|183108297|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
91607966|NCT02115308|183108297|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
91607967|NCT02115308|183108297|SUPERIORITY|non-adjusted||||||0.022|||||||t-test, 2 sided|||REST||||0.022
91607968|NCT02115308|183108297|SUPERIORITY|||||||0.001||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.001
91607969|NCT02115308|183108297|SUPERIORITY||||||<|0||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||<0.000
91607970|NCT02115308|183108297|SUPERIORITY|||||||0.006||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.006
91607971|NCT02115308|183108297|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||<0.000
91607972|NCT02115308|183108297|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Changes||||0.058
91607973|NCT02115308|183108297|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||0.310
91607974|NCT02115308|183108298|SUPERIORITY|||||||0.001|||||||paired, t-test|non adjusted||REST vs STRESS||||0.001
91607975|NCT02115308|183108298|SUPERIORITY|||||||0.002|||||||paired, t-test|non adjusted||REST vs STRESS||||0.002
91709996|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.231|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||7:50am||0.4|-1.8|0.2310
91607976|NCT02115308|183108298|SUPERIORITY|||||||0.721|||||||paired, t-test|non adjusted||REST vs STRESS||||0.721
91607977|NCT02115308|183108298|SUPERIORITY|||||||0.797|||||||t-test, 2 sided|non adjusted||REST||||0.797
91607978|NCT02115308|183108298|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|non adjusted||REST||||0.474
91607979|NCT02115308|183108298|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|non adjusted||||||0.537
91607980|NCT02115308|183108298|SUPERIORITY|||||||0.717|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.717
91607981|NCT02115308|183108298|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.041
91607982|NCT02115308|183108298|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.050
91607983|NCT02115308|183108298|SUPERIORITY|||||||0.908||||||non adjusted|t-test, 2 sided|||REST-to-STRESS Change||||0.908
91607984|NCT02115308|183108298|SUPERIORITY|||||||0.233|||||||t-test, 2 sided|non adjusted||||||0.233
91607985|NCT02115308|183108298|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.187
91607986|NCT02115308|183108300|SUPERIORITY|||||||0.008|||||||paired, t-test|non adjusted||REST vs STRESS||||0.008
91607987|NCT02115308|183108300|SUPERIORITY|||||||0.006|||||||paired, t-test|non adjusted||REST vs STRESS||||0.006
91607988|NCT02115308|183108300|SUPERIORITY|||||||0.428|||||||paired, t-test|non adjusted||REST vs STRESS||||0.428
91607989|NCT02115308|183108300|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
91607990|NCT02115308|183108300|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
91607991|NCT02115308|183108300|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|non adjusted||REST||||0.006
91607992|NCT02115308|183108300|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
91607993|NCT02115308|183108300|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||<0.000
91607994|NCT02115308|183108300|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.004
91607995|NCT02115308|183108300|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||<0.000
91607996|NCT02115308|183108300|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.172
91607997|NCT02115308|183108300|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.957
91613833|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103||||0.4759|TWO_SIDED|95.0|0.843|1.442|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.442|0.843|0.4759
91613834|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.656||||0.018|TWO_SIDED|95.0|0.462|0.93|||Regression, Logistic|||The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.930|0.462|0.0180
91652683|NCT04041570|183197295|OTHER|t-tests were only employed to determine which individuals were responders. Response rates with 95% Clopper-Pearson confidence intervals were reported within group.||||||0.05||||||The p-value was not adjusted for multiple comparisons and was only used to assess whether participants had a positive response or not.|t-test, 1 sided|This test was only used to determine whether participants were positive responders or not.||Statistical testing was performed within group and not between groups. Positivity for an individual was determined if there was a significant (p-value\<0.05) increase (one-sided test) in the ELISA titers at week 4 when compared to those at baseline. For each participant a t-test was performed to compare the triplicate baseline titers to their triplicate week 4 titers. The proportion of positive responses and associated Clopper-Pearson 95% was calculated within group.|For each participant, a positive response was defined as a significant increase in ELISA titer post vaccination (Week 4) from baseline (Week 0). Within each participant, a t-test is performed to compare the triplicate readings (replicates 1-3) post vaccination versus the triplicate readings at baseline. A participant is defined as a positive responder if one-sided t-test has p-value \< 0.05. The proportion of responders and associated 95% Clopper-Pearson Confidence Intervals were calculated.|||0.05
91652684|NCT01992107|183197329|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N1||1.14|0.93|
91652685|NCT01992107|183197329|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.05|||||TWO_SIDED|95.0|0.97|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2||1.14|0.97|
91652686|NCT01992107|183197329|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.1|0.89|
91652687|NCT01992107|183197329|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.14|0.87|
91652688|NCT01992107|183197330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|2.0|||||TWO_SIDED|95.0|-2.5|6.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N1||6.9|-2.5|
91709997|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8369|TWO_SIDED|95.0|-1.2|1.0|||Mixed Models Analysis|||7:50am||1.0|-1.2|0.8369
91652689|NCT01992107|183197330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|4.0|||||TWO_SIDED|95.0|-1.4|9.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N2||9.2|-1.4|
91652690|NCT01992107|183197330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|0.0|||||TWO_SIDED|95.0|-5.5|4.5|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||4.5|-5.5|
91652691|NCT01992107|183197330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|-2.0|||||TWO_SIDED|95.0|-6.5|3.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||3.2|-6.5|
91709998|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0035|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||7:50am||-0.5|-2.7|0.0035
91788228|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.5||0.603|TWO_SIDED|90.0|-1.69|3.24||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.24|-1.69|0.603
91709999|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0498|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|||7:50am||0.0|-2.2|0.0498
91710000|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||7:50am||-1.4|-3.6|<0.0001
91710001|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0007|TWO_SIDED|95.0|-3.0|-0.8|||Mixed Models Analysis|||7:50am||-0.8|-3.0|0.0007
91710002|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3198|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||7:50am||0.5|-1.6|0.3198
91788229|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|1.48||0.656|TWO_SIDED|90.0|-3.11|1.78||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.78|-3.11|0.656
91788230|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|1.52||0.228|TWO_SIDED|90.0|-0.67|4.34||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.34|-0.67|0.228
91652692|NCT01992107|183197336|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.25|||||TWO_SIDED|95.0|0.22|0.29||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.29|0.22|
91652693|NCT01992107|183197337|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-47.0|||||TWO_SIDED|95.0|-51.1|-42.1||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-42.1|-51.1|
91788231|NCT01375075|183456951|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.51||0.516|TWO_SIDED|90.0|-3.47|1.51||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.51|-3.47|0.516
91607998|NCT01309737|183108301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.0001|TWO_SIDED|95.0|5.33|17.68||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||17.68|5.33|<0.0001
91607999|NCT01309737|183108301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.43|||<|0.0001|TWO_SIDED|95.0|8.99|30.59||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.59|8.99|<0.0001
91652694|NCT01992107|183197338|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.38|||||TWO_SIDED|95.0|0.35|0.42||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.42|0.35|
91652695|NCT01992107|183197339|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-34.0|||||TWO_SIDED|95.0|-38.8|-29.3||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-29.3|-38.8|
91652696|NCT02022007|183197342|SUPERIORITY_OR_OTHER|||||||0.007|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.007
91652697|NCT02022007|183197343|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||This was a Subjects (SS)/Groups repeated measures design||||.02
91652698|NCT02022007|183197344|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|n||Pretreatment fasting glucose levels were compared with post-treatment levels||||<0.0001
91652699|NCT02022007|183197345|SUPERIORITY_OR_OTHER|||||||0.038|||||||ANOVA|||||||.038
91652700|NCT02022007|183197346|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
91608000|NCT01309737|183108301|SUPERIORITY_OR_OTHER||Percent difference|13.08|STANDARD_ERROR_OF_MEAN|3.62||0.0003|TWO_SIDED|95.0|5.99|20.17|||Normal approximation|||||20.17|5.99|0.0003
91652701|NCT02022007|183197347|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|||||||.025
91652702|NCT02022007|183197348|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||0.006
91652703|NCT02022007|183197349|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
91652704|NCT02022007|183197350|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||.026
91652705|NCT02022007|183197351|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
91652706|NCT02022007|183197352|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
91652707|NCT02022007|183197353|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
91652708|NCT05056727|183197436|OTHER||Treatment difference in mean slope|-0.7354||||0.4691|TWO_SIDED|95.0|-2.7311|1.2604||Test of no treatment difference in mean total eGFR-slope|Mixed Models Analysis||SZC minus Placebo|||1.2604|-2.7311|0.4691
91652709|NCT05056727|183197437|OTHER|Test of no treatment difference in mean chronic eGFR slope|Treatment difference in mean slope|-2.0421||||0.1338|TWO_SIDED|95.0|-4.7156|0.6314|||Mixed Models Analysis||SZC minus Placebo|||0.6314|-4.7156|0.1338
91652710|NCT05056727|183197438|OTHER|Test of treatment HR = 1|Hazard Ratio (HR)|1.72||||0.39|TWO_SIDED|95.0|0.5|5.9|||Regression, Cox||SZC relative to Placebo|||5.90|0.50|0.390
91652711|NCT05056727|183197439|OTHER|Test of treatment HR = 1|Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox||SZC relative to Placebo|||0.47|0.25|<0.001
91652712|NCT05056727|183197440|OTHER|Test of zero treatment difference|Mean Difference|301.1||||0.034|TWO_SIDED|95.0|23.15|579.11|||Regression, Linear||SZC minus Placebo|||579.11|23.15|0.034
91652713|NCT00895583|183197469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.239|TWO_SIDED|95.0|0.4|1.3||Two-sided alpha equals (=) 0.05.|Fisher Exact|||||1.3|0.4|0.239
91652714|NCT00895583|183197470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.422|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||||1.4|0.5|0.422
91652715|NCT00895583|183197471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.524|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||Month 12||1.4|0.5|0.524
91652716|NCT00895583|183197471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.298|TWO_SIDED|95.0|0.4|1.2||Alpha was unadjusted.|Fisher Exact|||Month 24||1.2|0.4|0.298
91788232|NCT01375075|183456952|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.11||0.513|TWO_SIDED|90.0|-2.57|1.11|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.11|-2.57|0.513
91788233|NCT01375075|183456952|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.12||0.97|TWO_SIDED|90.0|-1.82|1.9|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.90|-1.82|0.970
91788234|NCT01375075|183456952|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.16||0.824|TWO_SIDED|90.0|-1.66|2.17|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.17|-1.66|0.824
91788235|NCT01375075|183456952|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.12||0.769|TWO_SIDED|90.0|-2.18|1.52|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.52|-2.18|0.769
91608001|NCT01309737|183108302|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-45.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-52.98|-38.49||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-38.49|-52.98|<0.0001
91608002|NCT01309737|183108302|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.1|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-65.33|-50.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-50.86|-65.33|<0.0001
91608003|NCT01309737|183108302|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-18.24|-6.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-6.48|-18.24|<0.0001
91608004|NCT01309737|183108303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.5|||<|0.0001||95.0|3.48|17.31||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||17.31|3.48|<0.0001
91608005|NCT01309737|183108303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.53|||<|0.0001|TWO_SIDED|95.0|8.08|46.22||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||46.22|8.08|<0.0001
91608006|NCT01309737|183108303|SUPERIORITY_OR_OTHER||Percent Difference|14.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|7.72|20.88|||Normal Approximation|||||20.88|7.72|<0.0001
91608007|NCT01309737|183108305|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.97|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.8|-2.14||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-2.14|-3.80|<0.0001
91652717|NCT00895583|183197472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.055|TWO_SIDED|95.0|0.3|1.0||Alpha was unadjusted.|Fisher Exact|||Month 12||1.0|0.3|0.055
91652718|NCT00895583|183197472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.33|TWO_SIDED|95.0|0.4|1.3||Alpha was unadjusted.|Fisher Exact|||Month 24||1.3|0.4|0.330
91652719|NCT00895583|183197473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.543|TWO_SIDED|95.0|0.4|1.5||Alpha was unadjusted.|Fisher Exact|||Month 12||1.5|0.4|0.543
91788236|NCT01375075|183456953|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.33||0.735|TWO_SIDED|90.0|-0.65|0.43|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.43|-0.65|0.735
91788237|NCT01375075|183456953|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.33||0.503|TWO_SIDED|90.0|-0.32|0.76|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.76|-0.32|0.503
91788238|NCT01375075|183456953|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.988|TWO_SIDED|90.0|-0.53|0.54|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.54|-0.53|0.988
91710003|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.375|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|||8:50am||1.7|-0.6|0.3750
91788239|NCT01375075|183456953|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.32||0.207|TWO_SIDED|90.0|-0.95|0.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.13|-0.95|0.207
91608008|NCT01309737|183108305|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-5.13|-3.47||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.47|-5.13|<0.0001
91608009|NCT01309737|183108305|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.35||0.0001|TWO_SIDED|95.0|-2.01|-0.65|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.65|-2.01|0.0001
91608010|NCT01309737|183108305|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.46|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.51|-3.42||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.42|-5.51|<0.0001
91608011|NCT01309737|183108305|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-7.14|-5.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.05|-7.14|<0.0001
91608012|NCT01309737|183108305|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.43||0.0002|TWO_SIDED|95.0|-2.48|-0.79|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.79|-2.48|0.0002
91608013|NCT01309737|183108306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|1.89|8.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||8.95|1.89|<.0001
91608014|NCT01309737|183108306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25|||<|0.0001|TWO_SIDED|95.0|4.08|19.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||19.95|4.08|<.0001
91710004|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7978|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||8:50am||1.0|-1.3|0.7978
91710005|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.5197|TWO_SIDED|95.0|-1.5|0.8|||Mixed Models Analysis|||8:50am||0.8|-1.5|0.5197
91710006|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0751|TWO_SIDED|95.0|-2.2|0.1|||Mixed Models Analysis|||8:50am||0.1|-2.2|0.0751
91710007|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.1079|TWO_SIDED|95.0|-2.1|0.2|||Mixed Models Analysis|||8:50am||0.2|-2.1|0.1079
91788240|NCT01375075|183456954|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.43||0.756|TWO_SIDED|90.0|-0.57|0.84|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.84|-0.57|0.756
91788241|NCT01375075|183456954|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.43||0.99|TWO_SIDED|90.0|-0.71|0.7|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.70|-0.71|0.990
91788242|NCT01375075|183456954|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.565|TWO_SIDED|90.0|-0.47|0.97|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.97|-0.47|0.565
91788243|NCT01375075|183456954|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.43||0.678|TWO_SIDED|90.0|-0.53|0.89|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.89|-0.53|0.678
91608015|NCT01309737|183108306|SUPERIORITY_OR_OTHER||Percent difference|10.79|STANDARD_ERROR_OF_MEAN|3.02||0.0004|TWO_SIDED|95.0|4.87|16.71|||Normal Approximation|||||16.71|4.87|0.0004
91608016|NCT01309737|183108307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.1786|TWO_SIDED|95.0|0.74|4.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||4.62|0.74|0.1786
91608017|NCT01309737|183108307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18||||0.0003|TWO_SIDED|95.0|1.77|10.25||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||10.25|1.77|0.0003
91608018|NCT01309737|183108307|SUPERIORITY_OR_OTHER||Percent Difference|6.72|STANDARD_ERROR_OF_MEAN|2.26||0.0029|TWO_SIDED|95.0|2.3|11.14|||Normal Approximation|||||11.14|2.30|0.0029
91608019|NCT01309737|183108308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.06|||<|0.0001|TWO_SIDED|95.0|5.02|16.45||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||16.45|5.02|<0.0001
91652720|NCT00895583|183197473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.6|1.8||Alpha was unadjusted.|Fisher Exact|||Month 24||1.8|0.6|1.000
91652721|NCT00895583|183197475|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.3||0.019|TWO_SIDED|95.0|0.5|5.5||Alpha was unadjusted.|ANCOVA|Analysis of covariance (ANCOVA) with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 6||5.5|0.5|0.019
91652722|NCT00895583|183197475|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.5||0.215|TWO_SIDED|95.0|-4.8|1.1||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 12||1.1|-4.8|0.215
91652723|NCT00895583|183197475|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.722|TWO_SIDED|95.0|-2.7|3.9||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 18||3.9|-2.7|0.722
91652724|NCT00895583|183197475|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.71|TWO_SIDED|95.0|-3.0|4.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 24||4.4|-3.0|0.710
91652725|NCT00895583|183197476|SUPERIORITY_OR_OTHER||Slope difference (SRL-TAC)|-1.8||||0.131|TWO_SIDED|95.0|-4.2|0.5|||Random coefficient model||Random coefficient model with GFR as the dependent variable and study day as the independent variable.|Slope difference (sirolimus \[SRL\] minus tacrolimus \[TAC\])||0.5|-4.2|0.131
91652726|NCT00895583|183197478|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.105|TWO_SIDED|95.0|-8.6|0.8||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 6||0.8|-8.6|0.105
91652727|NCT00895583|183197478|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|3.3||0.023|TWO_SIDED|95.0|1.1|14.3||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 12||14.3|1.1|0.023
91652728|NCT00895583|183197478|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.4||0.955|TWO_SIDED|95.0|-6.8|6.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 18||6.4|-6.8|0.955
91652729|NCT00895583|183197478|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|5.8||0.582|TWO_SIDED|95.0|-8.2|14.6||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 24||14.6|-8.2|0.582
91652730|NCT00895583|183197479|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||||||0.006
91652731|NCT00895583|183197480|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 12 Post-transplantation||||1.000
91652732|NCT00895583|183197480|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 24 post-transplantation||||0.215
91652733|NCT00895583|183197481|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 6||||0.499
91652734|NCT00895583|183197481|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.067
91652735|NCT00895583|183197481|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 18||||0.061
91652736|NCT00895583|183197481|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||0.020
91652737|NCT00895583|183197484|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-therapy Period||||1.000
91652738|NCT00895583|183197484|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-therapy Period||||1.000
91652739|NCT00895583|183197485|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Baseline||||0.284
91608020|NCT01309737|183108308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.97|||<|0.0001||95.0|9.0|30.73||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.73|9.00|<0.0001
91608021|NCT01309737|183108308|SUPERIORITY_OR_OTHER||Percent difference|13.62||||0.0002|TWO_SIDED|95.0|6.54|20.69|||Normal Approximation|||||20.69|6.54|0.0002
91652740|NCT00895583|183197485|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.046
91652741|NCT00895583|183197485|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||1.000
91652742|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 12||||<0.001
91652743|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 24||||<0.001
91652744|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.824|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 12||||0.824
91608022|NCT01309737|183108309|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.44|STANDARD_ERROR_OF_MEAN|13.62||0.0062|TWO_SIDED|95.0|-64.19|-10.68||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-10.68|-64.19|0.0062
91608023|NCT01309737|183108309|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|13.75||0.0025|TWO_SIDED|95.0|-68.8|-14.78||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-14.78|-68.80|0.0025
91608024|NCT01309737|183108309|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.35|STANDARD_ERROR_OF_MEAN|10.98||0.692|TWO_SIDED|95.0|-25.91|17.21|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||17.21|-25.91|0.6920
91608025|NCT01309737|183108313|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608026|NCT01309737|183108313|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608027|NCT01309737|183108313|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608028|NCT01309737|183108314|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608029|NCT01309737|183108314|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91652745|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.735|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 24||||0.735
91652746|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 12||||<0.001
91652747|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.42|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 24||||0.001
91652748|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 12||||<0.001
91652749|NCT00895583|183197486|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.37|STANDARD_ERROR_OF_MEAN|0.16||0.028|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 24||||0.028
91652750|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Baseline||||0.429
91652751|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 12||||0.326
91608030|NCT01309737|183108314|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608031|NCT01309737|183108315|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608032|NCT01309737|183108315|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608033|NCT01309737|183108315|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91608034|NCT01442181|183108356|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month in minimally invasive group||||0.03
91652752|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 24||||0.517
91652753|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agents (insulin), Baseline||||1.000
91652754|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 12||||1.000
91652755|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 24||||0.223
91652756|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Baseline||||0.498
91652757|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 12||||0.566
91652758|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 24||||0.423
91652759|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Baseline||||0.033
91652760|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 12||||0.900
91608035|NCT01442181|183108356|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 month||||0.01
91608036|NCT01442181|183108356|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue in medical therapy group; baseline vs 3 month||||0.49
91608037|NCT01442181|183108356|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month||||0.06
91652761|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 24||||0.802
91652762|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Baseline||||0.260
91652763|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 12||||0.086
91788244|NCT01375075|183456955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.61||0.856|TWO_SIDED|90.0|-0.9|1.12|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.12|-0.90|0.856
91608038|NCT04233424|183108411|SUPERIORITY||Risk Ratio (RR)|-2.8||||0.152|TWO_SIDED|95.0|-6.7|1.0|||Cochran-Mantel-Haenszel|||||1.0|-6.7|0.152
91608039|NCT04233424|183108412|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.6219|TWO_SIDED|95.0|-3.9|2.3|||Cochran-Mantel-Haenszel|||||2.3|-3.9|0.6219
91652764|NCT00895583|183197487|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 24||||0.723
91652765|NCT00895583|183197488|SUPERIORITY_OR_OTHER||Treatment Ratio|1.71|||<|0.001|TWO_SIDED|95.0|1.38|2.11||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 12; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.11|1.38|<0.001
91652766|NCT00895583|183197488|SUPERIORITY_OR_OTHER||Treatment Ratio|1.77|||<|0.001|TWO_SIDED|95.0|1.39|2.26||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 24; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.26|1.39|<0.001
91652767|NCT00895583|183197489|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Pre-randomization||||1.000
91652768|NCT00895583|183197489|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period||||0.020
91652769|NCT00895583|183197489|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period||||0.021
91652770|NCT00895583|183197490|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha is unadjusted.|Fisher Exact|||||||<0.001
91652771|NCT00895583|183197491|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period, any treatment||||<0.001
91652772|NCT00895583|183197491|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period, any treatment||||0.685
91652773|NCT00895583|183197492|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.521|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.521
91652774|NCT00895583|183197493|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.25||0.265|TWO_SIDED|||||Alpha is unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.265
91652775|NCT00895583|183197494|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|10.02|STANDARD_ERROR_OF_MEAN|23.61||0.672|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.672
91652776|NCT00895583|183197495|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.45|STANDARD_ERROR_OF_MEAN|0.67||0.504|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.504
91652777|NCT00895583|183197496|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.56|STANDARD_ERROR_OF_MEAN|1.18||0.637|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.637
91652778|NCT00895583|183197497|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|1.48||0.955|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.955
91652779|NCT00895583|183197498|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|216.29|STANDARD_ERROR_OF_MEAN|198.84||0.279|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.279
91788245|NCT01375075|183456955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.869|TWO_SIDED|90.0|-0.9|1.1|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.10|-0.90|0.869
91788246|NCT01375075|183456955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.869|TWO_SIDED|90.0|-0.92|1.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.13|-0.92|0.869
91652780|NCT00895583|183197499|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.337|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.337
91788247|NCT01375075|183456955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.61||0.317|TWO_SIDED|90.0|-0.4|1.63|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.63|-0.40|0.317
91652781|NCT00895583|183197500|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset (from baseline up to On-Therapy Month 24)||||0.025
91652782|NCT00895583|183197500|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 1 year (from baseline up to On-Therapy Month 12)||||0.012
91652783|NCT00895583|183197500|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 2 years (from On-Therapy Month 12 to On-Therapy Month 24)||||1.000
91652784|NCT00895583|183197501|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (12-Month)||||1.000
91652785|NCT00895583|183197501|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (12-Month)||||1.000
91652786|NCT00895583|183197501|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (24-Month)||||0.386
91652787|NCT00895583|183197501|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (24-Month)||||1.000
91652788|NCT00895583|183197502|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|||||||0.129
91652789|NCT00895583|183197503|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
91652790|NCT00895583|183197504|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Fisher Exact|||||||0.276
91652791|NCT00895583|183197505|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Fisher Exact|||||||0.158
91652792|NCT02100956|183197548|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Null hypothesis was that there was no difference in VAS pain scale scores after intrathecal study drug injection between oxytocin and placebo. To account for repeated measures across time and drug conditions, VAS apin scale scores were analyzed using a linear mixed-effects model with random intercepts at the level of participant. Each outcome was regressed on fixed-effects for order of study day, study drug, time after injection, and drug x time interaction.||||<0.05
91788248|NCT01375075|183456957|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.888|TWO_SIDED|90.0|-0.24|0.2|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.20|-0.24|0.888
91652793|NCT03529955|183197554|EQUIVALENCE|The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||||0.01||||||The investigators hypothesized that genes identified as significantly differentially expressed between the two groups will have ≥2-fold change at p\<0.01.|ANOVA|||The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||0.01
91652794|NCT04526899|183197571|SUPERIORITY|||||||0.0148|||||||1-sided exact binomial test|||||||0.0148
91652795|NCT00220701|183197621|SUPERIORITY_OR_OTHER||F statistics|2.82||||0.1|TWO_SIDED||||||Repeated Measures ANOVA|||||||0.10
91652796|NCT03433274|183197648|OTHER|||||||0.0002|||||||one-sided 2.5% level of significance|||"The null and alternative hypotheses are:~H0: πD ≤ πPG H1: πD \> πPG where πD is the true event rate for freedom from all-cause mortality and HFH at 12 months and πPG is the performance goal (PG)."||||0.0002
91652797|NCT03433274|183197649|OTHER||||||<|0.0001|||||||Exact Binomial test|at a one-sided 2.5% level of significance||"The null and alternative hypotheses are stated as:~H0: PMR ≤ 1+ ≤ PPG H1: P MR ≤ 1+ \> PPG where PMR ≤ 1+ is the proportion of subjects who have MR ≤ 1+ at 30 days post index procedure."||||<0.0001
91652798|NCT03433274|183197650|OTHER||||||<|0.0001|||||||Paired t-test|at a one-sided 2.5% level of significance||"The null and alternative hypotheses are:~H0: D12M ≤ 0 H1: D12M \> 0 Where D12M is the average change in KCCQ score from baseline at 12 months."||||<0.0001
91652799|NCT03433274|183197651|OTHER||||||<|0.0001|||||||McNemar|at a two-sided 5% level of significance||"The null and alternative hypotheses are stated as:~H0: PM12 = PB H1: PM12 ≠ PB where PM12 and PB represent the proportion of NYHA Classification I or II at 12 months and baseline, respectively."||||<0.0001
91652800|NCT03433274|183197652|OTHER|||||||0.0338|||||||paired t-test|at a one-sided 2.5% significance level||"The null and alternative hypotheses are:~H0: D12M ≤ 0 H1: D12M \> 0 Where D12M is the average change in 6MWT distance from baseline at 12 months."||||0.0338
91710008|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0065|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|||8:50am||-0.5|-2.8|0.0065
91788249|NCT01375075|183456957|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.939|TWO_SIDED|90.0|-0.21|0.23|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.23|-0.21|0.939
91608040|NCT04233424|183108413|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.4373|TWO_SIDED|95.0|-2.8|1.2|||Kaplan-Meier Analysis|||||1.2|-2.8|0.4373
91608041|NCT02698189|183108414|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.000; upper = 0.415|||
91608042|NCT02698189|183108414|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.040; upper = 0.391|||
91608043|NCT03664726|183108445|SUPERIORITY|||||||0.0034||||||Comparison of differences by group|ANOVA|||||||0.0034
91608044|NCT03664726|183108446|SUPERIORITY|||||||0.76|||||||ANOVA|||||||0.76
91608045|NCT03664726|183108447|SUPERIORITY|||||||0.77|||||||ANOVA|||||||0.77
91608046|NCT03119649|183108454|SUPERIORITY||Difference in LS Means|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.4291|TWO_SIDED|95.0|-11.6|5.0||P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.0|-11.6|0.4291
91608047|NCT03119649|183108454|SUPERIORITY||Difference in LS Means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3477|TWO_SIDED|95.0|-12.8|4.6||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.6|-12.8|0.3477
91608048|NCT03119649|183108454|SUPERIORITY||Difference in LS Means|-15.8|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-23.2|-8.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||-8.3|-23.2|<0.0001
91608049|NCT03119649|183108454|SUPERIORITY||Difference in LS Means|-6.3|STANDARD_ERROR_OF_MEAN|3.76||0.0995|TWO_SIDED|95.0|-13.9|1.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||1.2|-13.9|0.0995
91608050|NCT03119649|183108455|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|2.11||0.594|TWO_SIDED|95.0|-3.1|5.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.4|-3.1|0.5940
91608051|NCT03119649|183108455|SUPERIORITY||Difference in LS Means|0.6|STANDARD_ERROR_OF_MEAN|2.06||0.7553|TWO_SIDED|95.0|-3.5|4.8||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.8|-3.5|0.7553
91608052|NCT03119649|183108455|SUPERIORITY||Difference in LS Means|1.0|STANDARD_ERROR_OF_MEAN|1.94||0.5958|TWO_SIDED|95.0|-2.9|4.9||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||4.9|-2.9|0.5958
91608053|NCT03119649|183108455|SUPERIORITY||Difference in LS Means|2.3|STANDARD_ERROR_OF_MEAN|1.94||0.2403|TWO_SIDED|95.0|-1.6|6.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||6.2|-1.6|0.2403
91608054|NCT03119649|183108456|SUPERIORITY||Difference in LS Means|2.7|STANDARD_ERROR_OF_MEAN|4.81||0.5749|TWO_SIDED|95.0|-6.9|12.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||12.4|-6.9|0.5749
91608055|NCT03119649|183108456|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.83||0.7381|TWO_SIDED|95.0|-8.1|11.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||11.3|-8.1|0.7381
91608056|NCT03119649|183108456|SUPERIORITY||Difference in LS Means|6.8|STANDARD_ERROR_OF_MEAN|4.43||0.1282|TWO_SIDED|95.0|-2.0|15.7||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||15.7|-2.0|0.1282
91608057|NCT03119649|183108456|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.43||0.7212|TWO_SIDED|95.0|-7.3|10.5||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||10.5|-7.3|0.7212
91613835|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.742||||0.0262|TWO_SIDED|95.0|0.57|0.965|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.965|0.570|0.0262
91652801|NCT04969939|183197661|SUPERIORITY||Treatment difference (%-point)|-2.15||||0.0437|TWO_SIDED|95.0|-4.24|-0.06|||ANCOVA|||Week 48 responses were analysed using an analysis of covariance model with randomised treatment as factors and baseline body weight (kg) as covariate.||-0.06|-4.24|0.0437
91652802|NCT02667067|183197726|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91652803|NCT01149616|183197821|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
91652804|NCT01149616|183197822|SUPERIORITY|||||||0.006|||||||ANOVA|||||||0.006
91652805|NCT01149616|183197823|SUPERIORITY|||||||0.05||||||P value was calculated, and threshold for significance calculated at less than or equal to 0.05|ANOVA|||||||0.05
91652806|NCT06268730|183197905|SUPERIORITY|||||||0.104||||||The a priori threshold for statistical significance \<0.05.|ANOVA|||||||0.104
91608058|NCT02333227|183108461|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
91608059|NCT02333227|183108462|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Co-primary outcomes|We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
91608060|NCT02333227|183108463|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91608061|NCT02333227|183108464|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||Specifically, the composite of periodontal disease was also created; this composite was positive if any of the following were detected: gingival bleeding, pockets of 4 mm or greater, or loss of attachment of 4 mm or greater. A scaled periodontal disease score was also created which was the sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present.|||<0.05
91608062|NCT02333227|183108465|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91608063|NCT01073943|183108489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|3.3|||||ONE_SIDED|97.5|-2.9||||||||||-2.9|
91608064|NCT01073943|183108490|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|-2.7|||||ONE_SIDED|97.5|-8.8||||||||||-8.8|
91608065|NCT01073943|183108491|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91608066|NCT01073943|183108492|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91523519|NCT04270747|182922883|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-2.2|2.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||2.2|-2.2|
91608067|NCT01073943|183108493|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91608068|NCT01073943|183108494|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91608069|NCT01073943|183108495|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91608070|NCT01073943|183108496|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91608071|NCT01073943|183108498|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|4.5|||||ONE_SIDED|97.5|-0.1|||||||Mid colon comparison|||-0.1|
91608072|NCT01073943|183108498|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|3.2|||||ONE_SIDED|97.5|-1.5|||||||Recto-sigmoid colon comparison|||-1.5|
91608073|NCT01073943|183108498|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|0.9|||||ONE_SIDED|97.5|-5.7|||||||Overall comparison: ascending colon, mid colon and recto-sigmoid colon|||-5.7|
91608074|NCT05662332|183108507|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Change difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|
91608075|NCT05662332|183108508|SUPERIORITY||LS Mean Change difference|-0.03||||0.684|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.684
91608076|NCT05662332|183108509|SUPERIORITY||LS Mean Change difference|4.16||||0.155|TWO_SIDED|95.0|-1.58|9.9|||ANCOVA|||Week 52||9.90|-1.58|0.155
91608077|NCT05662332|183108510|SUPERIORITY||LS Mean Change difference|-43.7|||<|0.001|TWO_SIDED|95.0|-62.4|-25.0|||Mixed Models Analysis|||Week 52||-25.0|-62.4|<0.001
91608078|NCT05662332|183108511|SUPERIORITY||Relative Rate|0.57||||0.005|TWO_SIDED|95.0|0.39|0.84|||Negative binomial model|||||0.84|0.39|0.005
91608079|NCT05662332|183108513|SUPERIORITY||Relative Rate|0.58||||0.155|TWO_SIDED|95.0|0.28|1.23|||Negative binomial model|||||1.23|0.28|0.155
91608080|NCT05662332|183108515|SUPERIORITY||LS Mean difference (Final Values)|0.57||||0.033|TWO_SIDED|95.0|0.047|1.1|||Mixed Models Analysis|||||1.10|0.047|0.033
91608081|NCT05662332|183108516|SUPERIORITY||LS Mean difference (Final Values)|1.56||||0.071|TWO_SIDED|95.0|-0.13|3.25|||Mixed Models Analysis|||Week 52||3.25|-0.13|0.071
91608082|NCT05662332|183108519|SUPERIORITY||LS Mean difference (Final Values)|1.8||||0.072|TWO_SIDED|95.0|-0.2|3.8|||Mixed Models Analysis|||Week 52||3.8|-0.2|0.072
91608083|NCT01446809|183108580|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91608084|NCT01446809|183108581|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91608085|NCT05198713|183108592|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91608086|NCT03063385|183108603|OTHER|\[Not specified\]|Slope|0.0153|STANDARD_ERROR_OF_MEAN|0.0067||0.0229|TWO_SIDED|95.0|0.0022|0.0285||Statistical significance taken at the 0.05 level|GEE modeling|P-value \& estimate rely on group x time interaction effect on primary outcome when controlling for self-efficacy. Used modified Baron \& Kenny method|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0285|0.0022|.0229
91608087|NCT03063385|183108603|OTHER|\[Not specified\]|Slope|0.0151|STANDARD_ERROR_OF_MEAN|0.0067||0.0249|TWO_SIDED|95.0|0.0019|0.0282||Statistical significance taken at the 0.05 level|GEE modeling|P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0282|0.0019|0.0249
91608088|NCT03063385|183108603|OTHER|\[Not specified\]|Slope|0.0158|STANDARD_ERROR_OF_MEAN|0.0068||0.0204|TWO_SIDED|95.0|0.0025|0.0292||Statistical significance taken at the 0.05 level|GEE modeling|Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0292|0.0025|0.0204
91608089|NCT00469079|183108660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.002
91608090|NCT00469079|183108661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Mixed Models Analysis|||Product use is by self-report and daily diaries.||||0.05
91608091|NCT00469079|183108662|SUPERIORITY_OR_OTHER_LEGACY||Other|0.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.||This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.||||<0.05
91608092|NCT00469079|183108663|SUPERIORITY_OR_OTHER_LEGACY||Mean difference between 3 groups|0.0|||>|0.1|TWO_SIDED|95.0|||||Mixed Models Analysis|||A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.||||> 0.10
91608093|NCT03818815|183108694|SUPERIORITY|||||||0.62||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.62
91652807|NCT06268730|183197906|SUPERIORITY|||||||0.061||||||the a priori threshold for statistical significance was \<0.05|ANOVA|||||||0.061
91523520|NCT04270747|182922883|OTHER||Difference between means|-0.6|||||TWO_SIDED|90.0|-2.9|1.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||1.7|-2.9|
91608094|NCT03818815|183108695|SUPERIORITY|||||||0.07||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.07
91608095|NCT04419506|183108696|OTHER||Posterior difference|88.4|||||TWO_SIDED|95.0|29.5|154.2|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||154.2|29.5|
91652808|NCT06268730|183197907|SUPERIORITY|||||||0.053||||||the a priori threshold for statistical significance was \<0.05|ANOVA|||||||0.053
91652809|NCT06268730|183197908|SUPERIORITY|||||||0.003||||||the a priori threshold for statistical significance was \<0.05|ANOVA|||||||0.003
91652810|NCT06268730|183197909|SUPERIORITY|||||||0.58||||||the a priori threshold for statistical significance was \<0.05|ANOVA|||||||0.58
91652811|NCT01711021|183197923|SUPERIORITY||Least Square (LS) mean difference|-5.87|||<|0.001|TWO_SIDED|95.0|-6.76|-4.97|||Mixed Models Analysis|Mixed model repeated measure (MMRM) analysis for SKAMP total score in Double-Blind period||||-4.97|-6.76|< 0.001
91608096|NCT04419506|183108696|OTHER||Posterior difference|62.4|||||TWO_SIDED|95.0|6.3|125.5|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||125.5|6.3|
91608097|NCT00345605|183108724|SUPERIORITY_OR_OTHER||Slope|0.5|||||TWO_SIDED||||||||Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|For sample size calculation, we used the means and standard deviation for PT, PTT. Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.||||
91608098|NCT00644592|183108780|SUPERIORITY_OR_OTHER||Ratio of mean effects|1.27|STANDARD_ERROR_OF_MEAN|0.16||0.015|TWO_SIDED|95.0|1.06|1.52|||t-test, 2 sided||The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\[since (B-A)-(A-B)=2B-2A\] so the actual estimate was based upon the antilog of half of this difference.|This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.||1.52|1.06|0.015
91608099|NCT00811252|183108789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.01||0.0011|TWO_SIDED|95.0|-5.31|-1.34||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.34|-5.31|0.0011
91608100|NCT00811252|183108789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-7.5|-3.46||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.46|-7.50|<0.0001
91608101|NCT00811252|183108790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|0.94||0.024|TWO_SIDED|95.0|-3.98|-0.28||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.28|-3.98|0.0240
91608102|NCT00811252|183108790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-6.1|-2.34||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-2.34|-6.10|<0.0001
91608103|NCT00811252|183108791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.85||0.2134|TWO_SIDED|95.0|-2.72|0.61||Since p-value \>0.05, hierarchically testing stopped here.|ANCOVA|||||0.61|-2.72|0.2134
91608104|NCT00811252|183108791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.86||0.0002|TWO_SIDED|95.0|-4.99|-1.6||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-1.60|-4.99|0.0002
91608105|NCT00811252|183108792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.7||0.6879|TWO_SIDED|95.0|-1.67|1.1||A nominal p-value is provided.|ANCOVA|||||1.10|-1.67|0.6879
91608106|NCT00811252|183108792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.72||0.0827|TWO_SIDED|95.0|-2.65|0.16||A nominal p-value is provided.|ANCOVA|||||0.16|-2.65|0.0827
91608107|NCT00811252|183108793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.55||0.4482|TWO_SIDED|95.0|-1.49|0.66||A nominal p-value is provided.|ANCOVA|||||0.66|-1.49|0.4482
91608108|NCT00811252|183108793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.56||0.7971|TWO_SIDED|95.0|-0.95|1.24||A nominal p-value is provided.|ANCOVA|||||1.24|-0.95|0.7971
91608109|NCT00811252|183108794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.29|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-6.32|-2.26||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-2.26|-6.32|<0.0001
91608110|NCT00811252|183108795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|0.74||0.0015|TWO_SIDED|95.0|-3.8|-0.91||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.91|-3.80|0.0015
91608111|NCT00811252|183108796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.32|-0.88|<0.0001
91608112|NCT00811252|183108797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.31|-0.82|<0.0001
91608113|NCT00811252|183108798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0552|TWO_SIDED|95.0|-0.88|0.01||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||0.01|-0.88|0.0552
91608114|NCT00811252|183108799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.0008|TWO_SIDED|95.0|0.26|0.7||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.70|0.26|0.0008
91608115|NCT00811252|183108800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.009|TWO_SIDED|95.0|0.27|0.83||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.83|0.27|0.0090
91608116|NCT01157117|183108802|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.0||||0.42|TWO_SIDED|95.0|-13.4|37.3||No adjustments were made to the p-value.|Fisher Exact|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher's Exact test with the null hypothesis that there was no difference between treatment groups.||37.3|-13.4|0.42
91608117|NCT00749606|183108828|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Mixed linear models analyzed within-subject variation in repeated measures over time. Intention to treat analysis used 5 imputations for missing data.||||||<0.01
91652812|NCT01711021|183197925|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91710009|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.2529|TWO_SIDED|95.0|-0.5|1.8|||Mixed Models Analysis|||8:50am||1.8|-0.5|0.2529
91652813|NCT02833415|183197941|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.9398|STANDARD_ERROR_OF_MEAN|0.2941||0.0053|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.0053
91652814|NCT02833415|183197941|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.152|STANDARD_ERROR_OF_MEAN|0.2424||0.5394|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.5394
91652815|NCT02324972|183198004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.636|TWO_SIDED|95.0|-1.3|1.25|||ANCOVA|||A sample size of 20 subjects per group was assumed to have 80% power to allow detection of a statistically significant difference in change from baseline in TLSS between the 2 groups, if the effect size was approximately less than or equal to 0.9. This is equivalent to detecting a difference of -4.5 between the 2 groups with a common standard deviation of 5. The primary analysis was doing using last observation carried forward (LOCF) imputed data.||1.25|-1.30|0.636
91652816|NCT02324972|183198005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.677|TWO_SIDED|95.0|-0.44|0.68|||ANOVA|||||0.68|-0.44|0.677
91652817|NCT02324972|183198006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219||||0.802|TWO_SIDED|95.0|-1.983|1.544|||ANOVA|||||1.544|-1.983|0.802
91652818|NCT02324972|183198007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.976|TWO_SIDED|95.0|-7.076|7.292|||ANOVA|||||7.292|-7.076|0.976
91652819|NCT02324972|183198008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.233|TWO_SIDED|95.0|-1.68|6.72|||ANOVA|||||6.72|-1.68|0.233
91710010|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.6364|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6364
91652820|NCT02398188|183198019|SUPERIORITY|||||||0.397|||||||Cochran-Mantel-Haenszel|||||||0.397
91652821|NCT02398188|183198020|SUPERIORITY|||||||0.379|||||||Cochran-Mantel-Haenszel|||||||0.379
91788250|NCT01375075|183456957|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.296|TWO_SIDED|90.0|-0.08|0.36|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.36|-0.08|0.296
91523521|NCT04270747|182922883|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.5|1.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||1.1|-3.5|
91652822|NCT00620763|183198022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.0||0.02||95.0|||||Mixed Models Analysis|Mixed model analysis of variance tested for treatment and feeding sequence effects.||16 subjects required to detect a difference in Calcium 47 absorption of 2 percentage points with 90% power, alpha = 0.05||||0.02
91788251|NCT01375075|183456957|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.181|TWO_SIDED|90.0|-0.04|0.4|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.40|-0.04|0.181
91652823|NCT00729859|183198023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.0075||0.28|TWO_SIDED|95.0|0.005|0.035|||paired t-test|||p value for the difference = 0.28||0.035|0.005|0.28
91652824|NCT05034731|183198036|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91652825|NCT05034731|183198037|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91652826|NCT00696709|183198079|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
91710011|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9417|TWO_SIDED|95.0|-1.1|1.0|||Mixed Models Analysis|||9:50am||1.0|-1.1|0.9417
91710012|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.02|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||9:50am||-0.2|-2.3|0.0200
91710013|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0527|TWO_SIDED|95.0|-2.1|0.0|||Mixed Models Analysis|||9:50am||0.0|-2.1|0.0527
91710014|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0107|TWO_SIDED|95.0|-2.5|-0.3|||Mixed Models Analysis|||9:50am||-0.3|-2.5|0.0107
91710015|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0303|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||9:50am||-0.1|-2.2|0.0303
91710016|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6889
91710017|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9552|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||10:50am||1.1|-1.2|0.9552
91788252|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.29|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|90.0|-53.16|-33.41||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-33.41|-53.16|<0.001
91788253|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.93|STANDARD_ERROR_OF_MEAN|6.02|<|0.001|TWO_SIDED|90.0|-86.89|-66.97||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-66.97|-86.89|<0.001
91788254|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.81|STANDARD_ERROR_OF_MEAN|6.08|<|0.001|TWO_SIDED|90.0|-100.87|-80.75||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-80.75|-100.87|<0.001
91788255|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.25|STANDARD_ERROR_OF_MEAN|5.96|<|0.001|TWO_SIDED|90.0|-77.12|-57.39||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-57.39|-77.12|<0.001
91788256|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|90.0|-52.88|-32.33||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-32.33|-52.88|<0.001
91608118|NCT01121406|183108838|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier DC rates|-12.5|||||TWO_SIDED|95.0|-31.1|6.0|||||"95% CI using Greenwood´s variance estimate.~Volasertib (BI 6727) minus Cytotoxic."|Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood's variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit||6.0|-31.1|
91608119|NCT01121406|183108839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.66|1.53|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.53|0.66|
91608120|NCT01121406|183108840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.63|1.42|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.42|0.63|
91608121|NCT01121406|183108843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.73|1.7|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.70|0.73|
91608122|NCT01121406|183108844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.61|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.61|0.40|
91608123|NCT01121406|183108845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.37|1.65|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.65|0.37|
91608124|NCT01121406|183108846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.93|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.93|0.39|
91608125|NCT01121406|183108847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.33|1.47|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.47|0.33|
91608126|NCT01121406|183108848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.77|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||0.77|0.09|
91608127|NCT00892437|183108865|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group - RTV group) in the response rate at Week 24 was greater than -12%.|Difference in percentages|-7.4|||||TWO_SIDED|95.0|-24.6|9.9|||||Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.||9.9|-24.6|
91710018|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.7558|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||10:50am||1.3|-1.0|0.7558
91788257|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.93|STANDARD_ERROR_OF_MEAN|6.17|<|0.001|TWO_SIDED|90.0|-89.15|-68.71||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-68.71|-89.15|<0.001
91788258|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.67|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|90.0|-104.08|-83.26||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-83.26|-104.08|<0.001
91608128|NCT00892437|183108866|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.3|||||TWO_SIDED|95.0|-25.9|9.4|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||9.4|-25.9|
91608129|NCT00892437|183108867|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-0.02||||0.87|TWO_SIDED|95.0|-0.25|0.22||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.22|-0.25|0.87
91608130|NCT00892437|183108868|SUPERIORITY_OR_OTHER||Difference in LSM|-0.03||||0.82|TWO_SIDED|95.0|-0.3|0.23||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.23|-0.30|0.82
91608131|NCT00892437|183108869|SUPERIORITY_OR_OTHER||Difference in LSM|10.0||||0.78|TWO_SIDED|95.0|-63.0|84.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||84|-63|0.78
91608132|NCT00892437|183108870|SUPERIORITY_OR_OTHER||Difference in LSM|47.0||||0.29|TWO_SIDED|95.0|-41.0|134.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||134|-41|0.29
91608133|NCT02580058|183108934|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.8253|TWO_SIDED|95.0|0.867|1.497|||Log Rank|1-sided||||1.497|0.867|0.8253
91608134|NCT02580058|183108934|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.2082|TWO_SIDED|95.0|0.672|1.179|||Log Rank|1-sided||||1.179|0.672|0.2082
91608135|NCT02580058|183108935|SUPERIORITY||Hazard Ratio (HR)|1.68|||>|0.9999|TWO_SIDED|95.0|1.31|2.16|||Log Rank|1-sided||||2.160|1.310|>0.9999
91608136|NCT02580058|183108935|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0301|TWO_SIDED|95.0|0.607|1.011|||Log Rank|1-sided||||1.011|0.607|0.0301
91652827|NCT00696709|183198080|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
91652828|NCT00696709|183198081|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
91652829|NCT00696709|183198082|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||||<|0.0001|||||||Longitudinal data analysis (LDA)|LDA with log-transformed VZV responses at each visit as response variables and visit as covariate.||||||<0.0001
91652830|NCT00696709|183198083|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
91652831|NCT00696709|183198083|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-9.2|8.8|||||Miettinen \& Nurminen|||8.8|-9.2|
91608137|NCT02580058|183108954|OTHER||Geometric Mean Ratio (Test/Reference, %)|110.0|||||TWO_SIDED|90.0|95.4|126.7||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||126.7|95.4|
91608138|NCT02580058|183108955|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|79.5|101.5||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||101.5|79.5|
91652832|NCT00696709|183198084|OTHER||Difference in Percentage|35.9|||<|0.001|TWO_SIDED|95.0|15.2|52.6|||Miettinen & Nurminen|||||52.6|15.2|<0.001
91652833|NCT00696709|183198084|OTHER||Difference in Percentage|40.4|||<|0.001|TWO_SIDED|95.0|19.6|57.0|||Miettinen & Nurminen|||||57.0|19.6|<0.001
91652834|NCT00696709|183198085|OTHER||Difference in Percentage|-4.7|||||TWO_SIDED|95.0|-25.3|16.1|||||Miettinen \& Nurminen|||16.1|-25.3|
91652835|NCT00696709|183198085|OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-16.9|24.9|||||Miettinen \& Nurminen|||24.9|-16.9|
91652836|NCT00696709|183198086|OTHER||Difference in Percentage|1.6||||0.48|TWO_SIDED|95.0|-9.3|8.4|||Miettinen & Nurminen|||||8.4|-9.3|0.480
91652837|NCT00696709|183198086|OTHER||Difference in Percentage|1.6||||0.469|TWO_SIDED|95.0|-9.2|8.8|||Miettinen & Nurminen|||||8.8|-9.2|0.469
91652838|NCT00696709|183198087|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
91608139|NCT02580058|183108956|OTHER||Geometric Mean Ratio (Test/Reference, %)|96.0|||||TWO_SIDED|90.0|87.0|106.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||106|87|
91608140|NCT02580058|183108957|OTHER||Geometric Mean Ratio (Test/Reference, %)|95.0|||||TWO_SIDED|90.0|88.0|104.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||104|88|
91608141|NCT02580058|183108958|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|76.0|107.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||107|76|
91608142|NCT02580058|183108959|OTHER||Geometric Mean Ratio (Test/Reference, %)|100.0|||||TWO_SIDED|90.0|60.0|168.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||168|60|
91608143|NCT05490771|183108976|SUPERIORITY|||||||0.0341|||||||one-sided exact binomial test|||The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.||||0.0341
91608144|NCT01564784|183109027|SUPERIORITY_OR_OTHER||Rate difference|51.4|||<|0.0001|TWO_SIDED|97.5|38.4|64.3|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||64.3|38.4|<0.0001
91652839|NCT00696709|183198087|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|6.0|||||Miettinen \& Nurminen|||6.0|-10.8|
91710019|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1824|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||10:50am||0.4|-1.9|0.1824
91608145|NCT01564784|183109028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0105|TWO_SIDED|97.5|0.568|0.993|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.993|0.568|0.0105
91608146|NCT01564784|183109029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0021|TWO_SIDED|95.0|0.297|0.809|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.809|0.297|0.0021
91608147|NCT01564784|183109030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|97.5|0.336|0.602|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.602|0.336|<0.0001
91608148|NCT01564784|183109031|SUPERIORITY_OR_OTHER||Rate difference|31.6|||<|0.0001|TWO_SIDED|95.0|22.6|40.6|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||40.6|22.6|<0.0001
91608149|NCT01564784|183109032|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||||||<0.0001
91608150|NCT01564784|183109033|SUPERIORITY_OR_OTHER|||||||0.3168|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal at Screening||||0.3168
91608151|NCT01564784|183109033|SUPERIORITY_OR_OTHER|||||||0.216|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal after remission||||0.2160
91608152|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.0139|TWO_SIDED|95.0|1.4|12.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Physical Functioning||12.3|1.4|0.0139
91608153|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.4||||0.0065|TWO_SIDED|95.0|3.2|19.5|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Role Functioning||19.5|3.2|0.0065
91608154|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.3307|TWO_SIDED|95.0|-6.9|2.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Emotional Functioning||2.3|-6.9|0.3307
91608155|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.1904|TWO_SIDED|95.0|-1.4|7.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Cognitive Functioning||7.0|-1.4|0.1904
91608156|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4||||0.0336|TWO_SIDED|95.0|0.7|16.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Social Functioning||16.1|0.7|0.0336
91608157|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.1572|TWO_SIDED|95.0|-1.7|10.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Global Health Status||10.3|-1.7|0.1572
91608158|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.1281|TWO_SIDED|95.0|-10.8|1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Dyspnoea||1.4|-10.8|0.1281
91608159|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.6207|TWO_SIDED|95.0|-8.7|5.2|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Insomnia||5.2|-8.7|0.6207
91608160|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0193|TWO_SIDED|95.0|-16.0|-1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Appetite Loss||-1.4|-16.0|0.0193
91608161|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.6249|TWO_SIDED|95.0|-4.4|7.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Constipation||7.3|-4.4|0.6249
91608162|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.1534|TWO_SIDED|95.0|-7.2|1.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Diarrhoea||1.1|-7.2|0.1534
91608163|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.4915|TWO_SIDED|95.0|-9.7|4.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Financial Difficulties||4.7|-9.7|0.4915
91608164|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4||||0.1789|TWO_SIDED|95.0|-10.8|2.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Fatigue||2.0|-10.8|0.1789
91608165|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.4578|TWO_SIDED|95.0|-6.0|2.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Nausea and Vomiting||2.7|-6.0|0.4578
91608166|NCT01564784|183109035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.8428|TWO_SIDED|95.0|-7.3|6.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Pain||6.0|-7.3|0.8428
91608167|NCT01564784|183109036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.171|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||0.07|-0.01|0.1710
91608168|NCT01564784|183109037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6||||0.1172|TWO_SIDED|95.0|-1.2|10.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||10.4|-1.2|0.1172
91608169|NCT01982630|183109075|OTHER||Difference of Least Squares Means|-0.23|||||TWO_SIDED|90.0|-4.59|4.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.13|-4.59|
91608170|NCT01982630|183109075|OTHER||Difference of Least Squares Means|-6.25|||||TWO_SIDED|90.0|-10.48|-2.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.01|-10.48|
91608171|NCT01982630|183109075|OTHER||Difference of Least Squares Means|6.02|||||TWO_SIDED|90.0|1.81|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|1.81|
91608172|NCT01982630|183109075|OTHER||Difference of Least Squares Means|1.5|||||TWO_SIDED|90.0|-2.65|5.64|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.64|-2.65|
91652840|NCT01261325|183198103|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|22.8|||<|0.001|TWO_SIDED|95.0|13.3|31.2||"Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant or similar, as accurate and appropriate."|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.2|13.3|<0.001
91652841|NCT01261325|183198103|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|23.2|||<|0.001|TWO_SIDED|95.0|13.8|31.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.6|13.8|<0.001
91652842|NCT01261325|183198104|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.39|||<|0.001|TWO_SIDED|95.0|1.6|3.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.6|1.6|<0.001
91652843|NCT01261325|183198104|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.19|||<|0.001|TWO_SIDED|95.0|1.5|3.3||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.3|1.5|<0.001
91608173|NCT01982630|183109075|OTHER||Difference of Least Squares Means|-4.52|||||TWO_SIDED|90.0|-8.52|-0.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-0.52|-8.52|
91652844|NCT01261325|183198105|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|15.8|||<|0.001|TWO_SIDED|95.0|7.6|24.2||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||24.2|7.6|<0.001
91608174|NCT01982630|183109075|OTHER||Difference of Least Squares Means|1.73|||||TWO_SIDED|90.0|-2.38|5.83|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.83|-2.38|
91608175|NCT01982630|183109076|OTHER||Difference of Least Squares Means|-2.11|||||TWO_SIDED|90.0|-4.55|0.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||0.32|-4.55|
91608176|NCT01982630|183109076|OTHER||Difference of Least Squares Means|2.53|||||TWO_SIDED|90.0|-0.61|5.66|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.66|-0.61|
91608177|NCT01982630|183109076|OTHER||Difference of Least Squares Means|4.64|||||TWO_SIDED|90.0|1.35|7.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||7.93|1.35|
91608178|NCT01982630|183109077|OTHER||Difference of Least Squares Means|-0.65|||||TWO_SIDED|90.0|-5.01|3.71|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||3.71|-5.01|
91608179|NCT01982630|183109077|OTHER||Difference of Least Squares Means|-6.42|||||TWO_SIDED|90.0|-10.66|-2.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.19|-10.66|
91608180|NCT01982630|183109077|OTHER||Difference of Least Squares Means|5.77|||||TWO_SIDED|90.0|1.57|9.97|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.97|1.57|
91608181|NCT01982630|183109077|OTHER||Difference of Least Squares Means|-0.15|||||TWO_SIDED|90.0|-4.29|4.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.00|-4.29|
91608182|NCT01982630|183109077|OTHER||Difference of Least Squares Means|-5.91|||||TWO_SIDED|90.0|-9.91|-1.92|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-1.92|-9.91|
91608183|NCT01982630|183109077|OTHER||Difference of Least Squares Means|0.51|||||TWO_SIDED|90.0|-3.6|4.62|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.62|-3.60|
91608184|NCT01982630|183109078|OTHER||Difference of Least Squares Means|-0.89|||||TWO_SIDED|90.0|-3.8|2.02|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.02|-3.80|
91608185|NCT01982630|183109078|OTHER||Difference of Least Squares Means|5.24|||||TWO_SIDED|90.0|1.34|9.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.15|1.34|
91608186|NCT01982630|183109078|OTHER||Difference of Least Squares Means|6.13|||||TWO_SIDED|90.0|2.05|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|2.05|
91608187|NCT01982630|183109079|OTHER||Difference of Least Squares Means|-0.57|||||TWO_SIDED|90.0|-3.71|2.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.57|-3.71|
91608188|NCT01982630|183109079|OTHER||Difference of Least Squares Means|7.77|||||TWO_SIDED|90.0|3.5|12.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.03|3.50|
91608189|NCT01982630|183109079|OTHER||Difference of Least Squares Means|8.34|||||TWO_SIDED|90.0|3.89|12.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.79|3.89|
91608190|NCT01982630|183109080|OTHER||Difference of Least Squares Means|1.35|||||TWO_SIDED|90.0|-2.4|5.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.09|-2.40|
91608191|NCT01982630|183109080|OTHER||Difference of Least Squares Means|8.29|||||TWO_SIDED|90.0|3.29|13.3|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||13.30|3.29|
91608192|NCT01982630|183109080|OTHER||Difference of Least Squares Means|6.95|||||TWO_SIDED|90.0|1.69|12.2|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.20|1.69|
91608193|NCT01982630|183109081|OTHER||Difference of Least Squares Means|2.46|||||TWO_SIDED|90.0|-1.42|6.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||6.34|-1.42|
91608194|NCT01982630|183109081|OTHER||Difference of Least Squares Means|9.61|||||TWO_SIDED|90.0|4.42|14.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||14.81|4.42|
91608195|NCT01982630|183109081|OTHER||Difference of Least Squares Means|7.15|||||TWO_SIDED|90.0|1.7|12.6|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.60|1.70|
91608196|NCT01982630|183109082|OTHER||Difference of Least Squares Means|-3.97|||||TWO_SIDED|90.0|-6.8|-1.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||-1.14|-6.80|
91608197|NCT01982630|183109082|OTHER||Difference of Least Squares Means|-0.7|||||TWO_SIDED|90.0|-4.33|2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.93|-4.33|
91652845|NCT01261325|183198105|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|18.1|||<|0.001|TWO_SIDED|95.0|10.4|26.4||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||26.4|10.4|<0.001
91652846|NCT01261325|183198109|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.82||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.82|0.56|<0.001
91652847|NCT01261325|183198109|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.54|0.79||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.79|0.54|<0.001
91608198|NCT01982630|183109082|OTHER||Difference of Least Squares Means|3.26|||||TWO_SIDED|90.0|-0.54|7.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.06|-0.54|
91652848|NCT01261325|183198110|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.53|0.8||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.80|0.53|<0.001
91652849|NCT01261325|183198110|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.47|0.71||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.71|0.47|<0.001
91652850|NCT01261325|183198111|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.009|TWO_SIDED|95.0|0.6|0.93||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.93|0.60|0.009
91652851|NCT01261325|183198111|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.85||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.85|0.55|<0.001
91652852|NCT02668302|183198112|SUPERIORITY|||||||0.4709|||||||t-test, 2 sided|P-values from two-sample T-test with equal variance assumption||||||0.4709
91652853|NCT00526890|183198136|OTHER|||||||0.3149|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.||||0.3149
91652854|NCT03611309|183198151|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.623|TWO_SIDED|95.0|-8.15|4.89||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear||FACIT-Pal Total score|||4.89|-8.15|.623
91652855|NCT03611309|183198152|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.555|TWO_SIDED|95.0|-0.29|0.15||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||Analysis of physical health score.||0.15|-0.29|.555
91652856|NCT03611309|183198152|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.983|TWO_SIDED|95.0|-0.2|0.2||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||Analysis of mental health score.||0.20|-0.20|.983
91652857|NCT03611309|183198154|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.997|TWO_SIDED|95.0|-2.09|2.1||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear||FACIT-Sp-12 Total Score|||2.10|-2.09|.997
91652858|NCT03611309|183198155|SUPERIORITY|||||||0.484||||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||"Analysis of question Help you live longer?"||||.484
91652859|NCT03611309|183198155|SUPERIORITY|||||||0.343||||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||"Analysis of question Cure your cancer?"||||.343
91652860|NCT03611309|183198155|SUPERIORITY|||||||0.908|||||||Regression, Linear|The a priori threshold for statistical significance was \< 0.05.||"Analysis of question Help you with problems you were having because of your cancer?"||||.908
91652861|NCT03611309|183198158|SUPERIORITY|||||||0.531||||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||||||.531
91652862|NCT03611309|183198159|SUPERIORITY|||||||0.871||||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||||||.871
91652863|NCT03611309|183198160|SUPERIORITY|||||||0.77||||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||"Analysis of question Help your loved one live longer?"||||.770
91652864|NCT03611309|183198160|SUPERIORITY|The a priori threshold for statistical significance was \< 0.05.||||||0.755|||||||Regression, Linear|||"Analysis of question Awareness after: Cure your loved one's cancer?"||||.755
91652865|NCT03611309|183198160|SUPERIORITY|||||||0.929||||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||"Analysis of question Awareness after: Help your loved one with problems due to the cancer?"||||.929
91652866|NCT04128696|183198161|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.973|TWO_SIDED|95.0|0.99|2.29||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.29|0.99|0.973
91608199|NCT01982630|183109083|OTHER||Difference of Least Squares Means|-1.58|||||TWO_SIDED|90.0|-5.31|2.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.15|-5.31|
91608200|NCT01982630|183109083|OTHER||Difference of Least Squares Means|2.52|||||TWO_SIDED|90.0|-2.32|7.35|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.35|-2.32|
91608201|NCT01982630|183109083|OTHER||Difference of Least Squares Means|4.1|||||TWO_SIDED|90.0|-0.96|9.16|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.16|-0.96|
91608202|NCT01982630|183109084|OTHER||Difference of Least Squares Means|-3.48|||||TWO_SIDED|90.0|-7.31|0.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||0.34|-7.31|
91608203|NCT01982630|183109084|OTHER||Difference of Least Squares Means|3.96|||||TWO_SIDED|90.0|-1.11|9.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.03|-1.11|
91652867|NCT04128696|183198162|SUPERIORITY||Hazard Ratio (HR)|4.44|||>|0.999|TWO_SIDED|95.0|2.01|9.82||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||9.82|2.01|>0.999
91652868|NCT04128696|183198163|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.989|TWO_SIDED|95.0|1.05|1.86||Nominal p-value was calculated based on the log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.86|1.05|0.989
91652869|NCT04128696|183198164|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.996|TWO_SIDED|95.0|1.1|1.99||Nominal p-value was calculated based on the log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||1.99|1.10|0.996
91608204|NCT01982630|183109084|OTHER||Difference of Least Squares Means|7.44|||||TWO_SIDED|90.0|2.16|12.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||12.73|2.16|
91608205|NCT01982630|183109085|OTHER||Difference of Least Squares Means|0.03|||||TWO_SIDED|90.0|-4.51|4.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||4.57|-4.51|
91608206|NCT01982630|183109085|OTHER||Difference of Least Squares Means|4.7|||||TWO_SIDED|90.0|-1.33|10.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||10.73|-1.33|
91652870|NCT04128696|183198165|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.98|2.43|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||2.43|0.98|
91608207|NCT01982630|183109085|OTHER||Difference of Least Squares Means|4.66|||||TWO_SIDED|90.0|-1.67|11.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.00|-1.67|
91652871|NCT04128696|183198166|SUPERIORITY||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|1.0|2.53|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.53|1.00|
91652872|NCT04128696|183198171|OTHER||Difference in Percentage|-5.3|||||TWO_SIDED|95.0|-14.6|4.0||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||4.0|-14.6|
91652873|NCT04128696|183198172|OTHER||Difference in Percentage|-13.3|||||TWO_SIDED|95.0|-27.8|1.5||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.5|-27.8|
91652874|NCT04128696|183198173|OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-22.4|-1.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.1|-22.4|
91652875|NCT04128696|183198174|OTHER||Difference in Percentage|-18.0|||||TWO_SIDED|95.0|-33.7|-1.4||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.4|-33.7|
91652876|NCT04128696|183198183|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.783|TWO_SIDED|95.0|0.78|1.77||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.77|0.78|0.783
91652877|NCT04128696|183198184|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.5|2.0||Nominal p-value was calculated based on the log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.50|0.500
91652878|NCT04128696|183198185|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.329|TWO_SIDED|95.0|0.62|1.34||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.34|0.62|0.329
91788259|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.01|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|90.0|-85.46|-64.57||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-64.57|-85.46|<0.001
91608208|NCT01982630|183109086|OTHER||Difference of Least Squares Means|3.34|||||TWO_SIDED|90.0|-0.7|7.39|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.39|-0.70|
91608209|NCT01982630|183109086|OTHER||Difference of Least Squares Means|8.88|||||TWO_SIDED|90.0|3.53|14.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||14.23|3.53|
91652879|NCT04128696|183198186|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.6|2.0||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.60|0.608
91652880|NCT03280537|183198188|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.014|TWO_SIDED|95.0|-1.05|-0.12||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.12|-1.05|0.0140
91710020|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3323|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|||10:50am||0.6|-1.7|0.3323
91710021|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0413|TWO_SIDED|95.0|-2.4|0.0|||Mixed Models Analysis|||10:50am||0.0|-2.4|0.0413
91608210|NCT01982630|183109086|OTHER||Difference of Least Squares Means|5.54|||||TWO_SIDED|90.0|-0.08|11.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.15|-0.08|
91608211|NCT01982630|183109087|OTHER||Difference of Least Squares Means|-3.55|||||TWO_SIDED|90.0|-6.98|-0.12|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.12|-6.98|
91608212|NCT01982630|183109087|OTHER||Difference of Least Squares Means|1.05|||||TWO_SIDED|90.0|-3.38|5.49|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.49|-3.38|
91608213|NCT01982630|183109087|OTHER||Difference of Least Squares Means|4.61|||||TWO_SIDED|90.0|-0.02|9.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||9.23|-0.02|
91608214|NCT01982630|183109088|OTHER||Difference of Least Squares Means|-1.16|||||TWO_SIDED|90.0|-4.59|2.28|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||2.28|-4.59|
91608215|NCT01982630|183109088|OTHER||Difference of Least Squares Means|8.65|||||TWO_SIDED|90.0|3.99|13.31|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.31|3.99|
91608216|NCT01982630|183109088|OTHER||Difference of Least Squares Means|9.8|||||TWO_SIDED|90.0|4.96|14.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.65|4.96|
91608217|NCT01982630|183109089|OTHER||Difference of Least Squares Means|-4.04|||||TWO_SIDED|90.0|-7.52|-0.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.56|-7.52|
91608218|NCT01982630|183109089|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|5.57|14.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.89|5.57|
91608219|NCT01982630|183109089|OTHER||Difference of Least Squares Means|14.27|||||TWO_SIDED|90.0|9.38|19.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||19.15|9.38|
91608220|NCT01982630|183109090|OTHER||Difference of Least Squares Means|-2.12|||||TWO_SIDED|90.0|-5.7|1.47|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||1.47|-5.70|
91608221|NCT01982630|183109090|OTHER||Difference of Least Squares Means|13.34|||||TWO_SIDED|90.0|8.64|18.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||18.03|8.64|
91608222|NCT01982630|183109090|OTHER||Difference of Least Squares Means|15.45|||||TWO_SIDED|90.0|10.53|20.38|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||20.38|10.53|
91608223|NCT01982630|183109091|OTHER||Difference of Least Squares Means|2.11|||||TWO_SIDED|90.0|-1.47|5.7|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.70|-1.47|
91608224|NCT01982630|183109091|OTHER||Difference of Least Squares Means|10.43|||||TWO_SIDED|90.0|5.73|15.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||15.13|5.73|
91608225|NCT01982630|183109091|OTHER||Difference of Least Squares Means|8.32|||||TWO_SIDED|90.0|3.4|13.24|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.24|3.40|
91608226|NCT01982630|183109107|OTHER||Difference of Least Squares Means|29.56|||||TWO_SIDED|90.0|4.34|54.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||54.77|4.34|
91608227|NCT01982630|183109107|OTHER||Difference of Least Squares Means|26.1|||||TWO_SIDED|90.0|2.02|50.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||50.19|2.02|
91608228|NCT01982630|183109107|OTHER||Difference of Least Squares Means|3.45|||||TWO_SIDED|90.0|-20.23|27.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||27.14|-20.23|
91608229|NCT01982630|183109107|OTHER||Difference of Least Squares Means|-26.45|||||TWO_SIDED|90.0|-49.96|-2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-2.93|-49.96|
91608230|NCT01982630|183109107|OTHER||Difference of Least Squares Means|-29.9|||||TWO_SIDED|90.0|-52.04|-7.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.77|-52.04|
91608231|NCT01982630|183109107|OTHER||Difference of Least Squares Means|-56.0|||||TWO_SIDED|90.0|-79.53|-32.48|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-32.48|-79.53|
91608232|NCT01982630|183109108|OTHER||Difference of Least Squares Means|14.96|||||TWO_SIDED|90.0|-10.25|40.18|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||40.18|-10.25|
91608233|NCT01982630|183109108|OTHER||Difference of Least Squares Means|6.57|||||TWO_SIDED|90.0|-17.52|30.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||30.65|-17.52|
91608234|NCT01982630|183109108|OTHER||Difference of Least Squares Means|8.4|||||TWO_SIDED|90.0|-15.29|32.08|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||32.08|-15.29|
91608235|NCT01982630|183109108|OTHER||Difference of Least Squares Means|-35.23|||||TWO_SIDED|90.0|-58.75|-11.72|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.72|-58.75|
91652881|NCT03280537|183198189|SUPERIORITY||Difference in Least Squares Means|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0017|TWO_SIDED|95.0|-0.8|-0.19||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.19|-0.80|0.0017
91652882|NCT03280537|183198190|SUPERIORITY||Difference in Least Squares Means|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.73|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.16|-0.73|0.0024
91652883|NCT03280537|183198191|SUPERIORITY||Difference in Least Squares Means|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.81|-0.27||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.27|-0.81|0.0001
91652884|NCT03280537|183198192|SUPERIORITY||Difference in Least Squares Means|-0.91|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.39|-0.44||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.44|-1.39|0.0002
91652885|NCT03280537|183198193|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.3||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.30|-0.87|<0.0001
91652886|NCT03280537|183198194|SUPERIORITY||Difference in Least Squares Means|-15.04|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-21.26|-8.82||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-8.82|-21.26|<0.0001
91652887|NCT03280537|183198195|SUPERIORITY||Difference in Least Squares Means|-0.63|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.35||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.35|-0.90|<0.0001
91652888|NCT03280537|183198196|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||1.89|0.02|0.1594
91652889|NCT03280537|183198197|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|20.61||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||20.61|0.00|1.0000
91652890|NCT03280537|183198198|SUPERIORITY||Odds Ratio (OR)|4.04||||0.0396|TWO_SIDED|95.0|1.07|15.25|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||15.25|1.07|0.0396
91710022|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0925|TWO_SIDED|95.0|-2.2|0.2|||Mixed Models Analysis|||10:50am||0.2|-2.2|0.0925
91710023|NCT01096680|183312459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7133|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||10:50am||0.9|-1.4|0.7133
91608236|NCT01982630|183109108|OTHER||Difference of Least Squares Means|-43.63|||||TWO_SIDED|90.0|-65.77|-21.5|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.50|-65.77|
91608237|NCT01982630|183109108|OTHER||Difference of Least Squares Means|-50.2|||||TWO_SIDED|90.0|-73.72|-26.68|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-26.68|-73.72|
91608238|NCT01982630|183109109|OTHER||Difference of Least Squares Means|-31.2|||||TWO_SIDED|90.0|-56.59|-5.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.81|-56.59|
91608239|NCT01982630|183109109|OTHER||Difference of Least Squares Means|-25.12|||||TWO_SIDED|90.0|-50.25|0.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||0.01|-50.25|
91608240|NCT01982630|183109109|OTHER||Difference of Least Squares Means|-6.08|||||TWO_SIDED|90.0|-17.31|5.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||5.14|-17.31|
91608241|NCT01982630|183109110|OTHER||Difference of Least Squares Means|-27.48|||||TWO_SIDED|90.0|-52.87|-2.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-2.09|-52.87|
91652891|NCT03280537|183198199|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||1.89|0.02|0.1594
91652892|NCT03280537|183198200|SUPERIORITY||Odds Ratio (OR)|6.22||||0.0139|TWO_SIDED|95.0|1.23|60.23||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||60.23|1.23|0.0139
91652893|NCT03280537|183198201|SUPERIORITY||Difference in Least Squares Means|-2.09|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.0|-1.18||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-1.18|-3.00|<0.0001
91788260|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.28|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-58.53|-42.04||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-42.04|-58.53|<0.001
91608242|NCT01982630|183109110|OTHER||Difference of Least Squares Means|-30.59|||||TWO_SIDED|90.0|-55.72|-5.46|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.46|-55.72|
91608243|NCT01982630|183109110|OTHER||Difference of Least Squares Means|3.11|||||TWO_SIDED|90.0|-8.11|14.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||14.34|-8.11|
91652894|NCT03280537|183198202|SUPERIORITY||Difference in Least Squares Means|3.86|STANDARD_ERROR_OF_MEAN|1.16||0.0011|TWO_SIDED|95.0|1.57|6.15||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.15|1.57|0.0011
91652895|NCT03118739|183198218|SUPERIORITY||Mean % Change from Baseline|-39.37|||||TWO_SIDED|90.0|-61.785|-3.814||||||||-3.814|-61.785|
91652896|NCT07174544|183198305|SUPERIORITY|Superiority was assessed by comparing outcomes between the intervention and wait-list control groups over time.|||||||||||||Generalized estimating equations (GEE)|Generalized estimating equations were used to examine changes in outcomes over time between groups, accounting for repeated measurements.|||Analyses followed the intention-to-treat principle using available data at each assessment time point. Descriptive statistics were used to summarize baseline characteristics.|||
91608244|NCT01982630|183109111|OTHER||Difference of Least Squares Means|4.59|||||TWO_SIDED|90.0|-20.88|30.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||30.06|-20.88|
91608245|NCT01982630|183109111|OTHER||Difference of Least Squares Means|-5.42|||||TWO_SIDED|90.0|-30.68|19.85|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||19.85|-30.68|
91608246|NCT01982630|183109111|OTHER||Difference of Least Squares Means|10.01|||||TWO_SIDED|90.0|-1.77|21.78|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||21.78|-1.77|
91710024|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
91710025|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-25.4|||Mixed Models Analysis|||||-25.4|-45.5|<0.0001
91710026|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.7|||<|0.0001|TWO_SIDED|95.0|-36.7|-16.6|||Mixed Models Analysis|||||-16.6|-36.7|<0.0001
91608247|NCT01982630|183109112|OTHER||Difference of Least Squares Means|-14.98|||||TWO_SIDED|90.0|-40.53|10.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.57|-40.53|
91608248|NCT01982630|183109112|OTHER||Difference of Least Squares Means|-14.5|||||TWO_SIDED|90.0|-39.77|10.76|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.76|-39.77|
91608249|NCT01982630|183109112|OTHER||Difference of Least Squares Means|-0.48|||||TWO_SIDED|90.0|-12.47|11.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||11.52|-12.47|
91608250|NCT01982630|183109113|OTHER||Difference of Least Squares Means|-43.68|||||TWO_SIDED|90.0|-65.81|-21.55|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.55|-65.81|
91608251|NCT01982630|183109113|OTHER||Difference of Least Squares Means|-47.4|||||TWO_SIDED|90.0|-69.35|-25.45|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-25.45|-69.35|
91608252|NCT01982630|183109113|OTHER||Difference of Least Squares Means|3.72|||||TWO_SIDED|90.0|-5.76|13.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||13.19|-5.76|
91608253|NCT01982630|183109114|OTHER||Difference of Least Squares Means|-34.01|||||TWO_SIDED|90.0|-56.14|-11.88|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.88|-56.14|
91608254|NCT01982630|183109114|OTHER||Difference of Least Squares Means|-39.2|||||TWO_SIDED|90.0|-61.15|-17.26|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-17.26|-61.15|
91608255|NCT01982630|183109114|OTHER||Difference of Least Squares Means|5.2|||||TWO_SIDED|90.0|-4.28|14.67|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||14.67|-4.28|
91608256|NCT01982630|183109115|OTHER||Difference of Least Squares Means|-23.73|||||TWO_SIDED|90.0|-45.89|-1.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.56|-45.89|
91608257|NCT01982630|183109115|OTHER||Difference of Least Squares Means|-33.95|||||TWO_SIDED|90.0|-55.93|-11.98|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.98|-55.93|
91608258|NCT01982630|183109115|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|0.56|19.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||19.89|0.56|
91608259|NCT01982630|183109116|OTHER||Difference of Least Squares Means|-23.49|||||TWO_SIDED|90.0|-45.65|-1.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.32|-45.65|
91608260|NCT01982630|183109116|OTHER||Difference of Least Squares Means|-29.76|||||TWO_SIDED|90.0|-51.74|-7.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.79|-51.74|
91608261|NCT01982630|183109116|OTHER||Difference of Least Squares Means|6.27|||||TWO_SIDED|90.0|-3.39|15.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||15.93|-3.39|
91608262|NCT01273818|183109183|SUPERIORITY_OR_OTHER||Fscher exact test|||||0.198|TWO_SIDED||||||Fisher Exact||we did not need an estimation parameter such as odds or relative risk because of our experimental design and hypothesis of this study.|"Comparison Group Selection: our primary outcome is infection positive or negativeso, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is  positive infection frequencies are same for three groups. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%."||||0.198
91608263|NCT00803114|183109186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.05||95.0|0.12|0.41|||Fisher Exact||Relative risk describes the risk of requiring additional analgesics in the first 24 hours postpartum with the denominator being the arm which received placebo.|Relative risk ratio estimation with 95% CI using exact methods||0.41|0.12|0.05
91608264|NCT00803114|183109187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8||0.05||95.0|-5.7|-2.3|||t-test, 2 sided|degrees of freedom 226|The epidural morphine group represents the baseline of comparison for difference in means, with the placebo group requiring additional analgesics earlier.|||-2.3|-5.7|0.05
91652897|NCT03419234|183198315|SUPERIORITY|||||||0.049|||||||Log Rank|Stratified log rank test||||||0.049
91652898|NCT05918952|183198327|SUPERIORITY||Odds Ratio (OR)|2.19||||0.05|TWO_SIDED|95.0|1.21|3.98|||Regression, Logistic|||||3.98|1.21|.05
91652899|NCT05918952|183198328|OTHER||Odds Ratio (OR)|1.81|||<|0.001|TWO_SIDED|95.0|1.35|2.41|||Regression, Logistic|||Hypothesis: Higher General Sentiment (GS) scores will be associated with greater likelihood of COVID-19 testing uptake.||2.41|1.35|<0.001
91652900|NCT05918952|183198329|OTHER||Odds Ratio (OR)|3.54|||<|0.001|TWO_SIDED|95.0|2.01|6.2|||Regression, Logistic|||Hypothesis: Higher VFS scores will be associated with increased likelihood of test uptake.||6.20|2.01|<0.001
91652901|NCT05918952|183198329|OTHER||Odds Ratio (OR)|11.01||||0.029|TWO_SIDED|95.0|1.27|95.17||Low sample size and power. Model considered unstable and potentially overfit. Results not reliable.|Regression, Logistic|||Hypothesis: Higher VFS scores will be associated with increased likelihood of completion of a follow-up test.||95.17|1.27|0.029
91608265|NCT00803114|183109188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3||0.05||95.0|0.7|1.8|||t-test, 2 sided|degrees of freedom 212|Difference in VAS score when compared to the baseline group, subjects receiving epidural morphine|||1.8|0.7|0.05
91608266|NCT00803114|183109189|SUPERIORITY_OR_OTHER|||||||0.8||||||Fisher's exact test result did not reveal statistically significant differences between expected and real frequencies in any of the categories.|Fisher Exact|||||||0.80
91608267|NCT01696461|183109191|OTHER||||||||||||||||||Percentage of donors mobilized with plerixafor. No comparison group was analyzed.|||
91710027|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
91608268|NCT01696461|183109192|OTHER||||||||||||||||||This is a descriptive analysis. Percentage of donor experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. Grade of maximum toxicity across all time points is reported.|||
91608269|NCT01696461|183109193|OTHER||||||||||||||||||This is a descriptive analysis. The number of donors experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and one, six, and 12 months post-donation. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3.|||
91608270|NCT01696461|183109194|OTHER||||||||||||||||||At 100 days after HCT, all patients in both the MAC and the RIC cohorts had achieved neutrophil engraftment. All patients in the MAC arm and 97% of patients in the RIC arm had achieved platelet engraftment. The median time to neutrophil engraftment was 13 and 15 days for MAC and RIC, respectively. The median time to platelet engraftment was 19 and 18 days for MAC and RIC, respectively.|||
91608271|NCT01696461|183109195|OTHER||||||||||||||||||"Full donor myeloid chimerism was achieved relatively quickly in both RIC and MAC groups (median 100% at day +28 in both RIC and MAC), but conversion to full donor T-cell chimerism appeared to be slower in the RIC patients.~T-cell chimerism for MAC patients: median donor cell % (range):~Day +28: 92(59-100)%, Day +100: 97(76-100)%, Day +180: 100(91-100)%, Day +365: 100(100-100)%~T-cell chimerism for RIC patients: median donor cell % (range):~Day +28: 80(50-100)%, Day +100: 84(64-100)%, Day +180: 95(74-100)%, Day +365: 100(87-100)%"|||
91608272|NCT01696461|183109196|OTHER||||||||||||||||||This is a descriptive outcome.There were no cases of primary graft failure.|||
91608273|NCT01696461|183109197|OTHER|||||||||||||||||The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of acute GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing risk.|||
91608274|NCT01696461|183109198|OTHER||||||||||||||||||Immune reconstitution was measured by CD3+CD4+ and CD3+CD8+ T cells in the peripheral blood of patients at days 28, 100, 180, and 365 after HCT. Notably, median CD3+CD4+ cell counts were \>200/µL at all times analyzed, including day 28 in both MAC and RIC groups.|||
91608275|NCT01696461|183109199|OTHER|||||||||||||||||Groups were not directly compared using a statistical test.|Percentage of recipients at-risk for CMV reactivation who experienced a reactivation.|||
91608276|NCT01696461|183109200|OTHER|||||||||||||||||The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|The incidence of treatment-related mortality and relapse was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. When computing the cumulative incidence probability of treatment-related mortality and relapse, relapse and treatment-related mortality, respectively, were considered as a competing risk.|||
91608277|NCT01696461|183109201|OTHER|||||||||||||||||The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|Kaplan-Meier curves were used to estimate the probability of progression-free survival and overall survival. Progression-free survival at 1 year was 53% (95% CI, 36% to 71%) after MAC and 64% (95% CI, 47% to 79%) after RIC. Overall survival at 1 year was 63% (95% CI, 46% to 79%) after MAC and 70% (95% CI, 53% to 84%) after RIC.|||
91608278|NCT01696461|183109202|OTHER|||||||||||||||||This outcome measure is descriptive.|This outcome measure is descriptive. The median cell dose and range are reported.|||
91608279|NCT01696461|183109203|OTHER|||||||||||||||||The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of chronic GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing event.|||
91608280|NCT01696461|183109204|OTHER||||||||||||||||||This is a descriptive analysis. There were no cases of secondary graft failure.|||
91608281|NCT01696461|183109205|OTHER||||||||||||||||||This outcome measure is descriptive. The median cell dose and range are reported.|||
91608282|NCT03414359|183109233|NON_INFERIORITY|As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.||||||0.1||||||The a priori threshold for statistical significance is, \<0.05|Wilcoxon (Mann-Whitney)|||To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.||||0.10
91652902|NCT05918952|183198330|OTHER||Odds Ratio (OR)|1.69||||0.003|TWO_SIDED|95.0|1.19|2.4|||Regression, Logistic|||Hypothesis: Higher Practical Support (PS) scores will be associated with greater likelihood of COVID-19 testing uptake.||2.40|1.19|0.003
91710028|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9945|TWO_SIDED|95.0|-10.1|10.0|||Mixed Models Analysis|||||10.0|-10.1|0.9945
91710029|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.0814|TWO_SIDED|95.0|-18.9|1.1|||Mixed Models Analysis|||||1.1|-18.9|0.0814
91710030|NCT01096680|183312460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.9743|TWO_SIDED|95.0|-10.2|9.9|||Mixed Models Analysis|||||9.9|-10.2|0.9743
91608283|NCT04068103|183109245|SUPERIORITY|||||||0.98||||||P value \<= 0.35 moves trial to phase III, \>0.35 stops trial for futility. Decision rule calls for early stopping due to futility.|Fisher Exact|||One-sided Fisher's Exact Test of ctDNA clearance by treatment arm.||||0.98
91608284|NCT02396147|183109299|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|87.09|||||TWO_SIDED|90.0|58.56|129.52|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference)\*100|||129.52|58.56|
91608285|NCT02396147|183109299|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|83.09|||||TWO_SIDED|90.0|59.95|115.18|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||115.18|59.95|
91608286|NCT02396147|183109299|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.59|||||TWO_SIDED|90.0|52.88|116.79|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||116.79|52.88|
91608287|NCT02396147|183109299|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.23|||||TWO_SIDED|90.0|67.98|130.61|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||130.61|67.98|
91652903|NCT00101582|183198332|SUPERIORITY_OR_OTHER||Chi-Square Statistic|4.1764||||0.041||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.||||0.0410
91652904|NCT00101582|183198333|SUPERIORITY_OR_OTHER||Chi-Square Statistic|5.8002||||0.016||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0160
91608288|NCT02396147|183109300|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.53|||||TWO_SIDED|90.0|74.83|119.4|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (Reference) \*100|||119.40|74.83|
91608289|NCT02396147|183109300|SUPERIORITY_OR_OTHER||Geometric Mean Ration|77.99|||||TWO_SIDED|90.0|64.29|94.61|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.61|64.29|
91608290|NCT02396147|183109300|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.08|||||TWO_SIDED|90.0|64.21|102.37|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.37|64.21|
91608291|NCT02396147|183109300|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.78|||||TWO_SIDED|90.0|76.48|112.55|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.55|76.48|
91608292|NCT02396147|183109301|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.43|||||TWO_SIDED|90.0|74.85|119.12|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference) \* 100|||119.12|74.85|
91608293|NCT02396147|183109301|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.09|||||TWO_SIDED|90.0|64.53|94.51|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.51|64.53|
91608294|NCT02396147|183109301|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.16|||||TWO_SIDED|90.0|64.36|102.34|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.34|64.36|
91608295|NCT02396147|183109301|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.99|||||TWO_SIDED|90.0|76.84|112.54|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.54|76.84|
91608296|NCT02907944|183109317|SUPERIORITY||Odds Ratio (OR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.45|||Generalized Estimating Equation|||||1.45|0.82|0.55
91608297|NCT02907944|183109317|SUPERIORITY||Odds Ratio (OR)|1.76||||0.09|TWO_SIDED|95.0|0.92|3.37|||Generalized Estimating Equation|||||3.37|0.92|0.09
91608298|NCT02907944|183109317|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Generalized Estimating Equation|||||1.71|1.14|0.001
91608299|NCT02907944|183109318|SUPERIORITY||Odds Ratio (OR)|1.08||||0.59|TWO_SIDED|95.0|0.81|1.45|||Generalized Estimating Equation|||||1.45|0.81|0.59
91608300|NCT02907944|183109318|SUPERIORITY||Odds Ratio (OR)|1.77||||0.11|TWO_SIDED|95.0|0.88|3.55|||Generalized Estimating Equation|||||3.55|0.88|0.11
91608301|NCT02907944|183109318|SUPERIORITY||Odds Ratio (OR)|1.35||||0.005|TWO_SIDED|95.0|1.09|1.66|||Generalized Estimating Equation|||||1.66|1.09|0.005
91652905|NCT00101582|183198333|SUPERIORITY_OR_OTHER|||||||0.1122||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.||||0.1122
91710031|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6||||0.0544|TWO_SIDED|95.0|-19.4|0.2|||Mixed Models Analysis|||9:15pm||0.2|-19.4|0.0544
91608302|NCT02559505|183109331|OTHER|||||||0.005||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.005
91608303|NCT02559505|183109331|OTHER|||||||0.024||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.024
91608304|NCT02559505|183109332|OTHER|||||||0.408||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.408
91608305|NCT02559505|183109332|OTHER|||||||0.004||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.004
91608306|NCT02559505|183109333|OTHER|||||||0.991||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.991
91608307|NCT02559505|183109333|OTHER|||||||0.334||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.334
91608308|NCT02559505|183109334|OTHER|||||||0.226||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.226
91608309|NCT02559505|183109334|OTHER|||||||0.036||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.036
91608310|NCT02559505|183109335|OTHER|||||||0.68||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.680
91608311|NCT02559505|183109335|OTHER|||||||0.002||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.002
91608312|NCT03523585|183109339|SUPERIORITY||Hazard Ratio (HR)|0.3589|||<|1e-06|TWO_SIDED|95.0|0.284|0.4535||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.4535|0.2840|<0.000001
91608313|NCT03523585|183109340|SUPERIORITY||Hazard Ratio (HR)|0.6575||||0.0021|TWO_SIDED|95.0|0.5023|0.8605||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.8605|0.5023|0.0021
91608314|NCT03523585|183109341|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for BICR Assessment||||<0.0001
91608315|NCT03523585|183109341|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for Investigator Assessment||||<0.0001
91608316|NCT03523585|183109343|SUPERIORITY||Hazard Ratio (HR)|0.2828|||<|1e-06|TWO_SIDED|95.0|0.227|0.3524||Stratified Log-rank p-value.|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.3524|0.2270|<0.000001
91608317|NCT02874794|183109364|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.7827|TWO_SIDED|95.0|-17.6|13.2|||ANCOVA|||||13.2|-17.6|0.7827
91608318|NCT02874794|183109367|SUPERIORITY||Ratio of Geometric Means|0.6667|||<|0.0001|TWO_SIDED|95.0|0.5858|0.7589|||ANCOVA|||||0.7589|0.5858|<.0001
91608319|NCT02874794|183109368|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5792|TWO_SIDED|95.0|-0.58|0.33|||ANCOVA|||||0.33|-0.58|0.5792
91608320|NCT02874794|183109369|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.02|-1.59|||ANCOVA|||||-1.59|-4.02|<.0001
91608321|NCT02874794|183109370|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.8617|TWO_SIDED|95.0|-0.33|0.27|||ANCOVA|||||0.27|-0.33|0.8617
91608322|NCT02874794|183109371|SUPERIORITY||Median Difference (Final Values)|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75|||ANCOVA|||vs Enalapril||-0.75|-2.76|0.0007
91608323|NCT02874794|183109372|SUPERIORITY||Median Difference (Final Values)|0.63||||0.2354|TWO_SIDED|95.0|-0.41|1.68|||ANCOVA|||||1.68|-0.41|0.2354
91608324|NCT02874794|183109373|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8215|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||||0.04|-0.05|0.8215
91608325|NCT02874794|183109374|SUPERIORITY||Median Difference (Final Values)|-1.58||||0.0452|TWO_SIDED|95.0|-3.13|-0.03|||ANCOVA|||||-0.03|-3.13|0.0452
91608326|NCT02874794|183109375|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0242|TWO_SIDED|95.0|-3.68|-0.26|||ANCOVA|||||-0.26|-3.68|0.0242
91652906|NCT00101582|183198334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6603||||0.0261|TWO_SIDED|95.0|0.4546|0.9592|||Stratified Log-Rank test|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.|||0.9592|0.4546|0.0261
91652907|NCT00101582|183198334|SUPERIORITY_OR_OTHER|||||||0.1566||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Stratified Log-Rank test|||||||0.1566
91608327|NCT00698516|183109381|SUPERIORITY_OR_OTHER||Greenwood variance|65.0|STANDARD_ERROR_OF_MEAN|7.07||0.017|TWO_SIDED|95.0|49.3|76.9||Historical data in target population showed 3-month PFS rates of \<=50%. Oral topotecan with IV bevacizumab would provide clinically meaningful improvement in 3-month PFS if it could demonstrate a 40% improvement relative to the historical data.|Z statistic|Z statistic was used to reject the null hypothesis provided Z\>=1.65, where Z = (KM estimate at 3 months - null hypothesis value \[50%\])/Greenwood SE.||||76.9|49.3|0.017
91608328|NCT03090191|183109408|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|31.0|||||TWO_SIDED|96.4|-38.7|66.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||66.6|-38.7|
91608329|NCT03090191|183109409|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|28.6|||||TWO_SIDED|96.4|-28.4|61.0|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||61.0|-28.4|
91608330|NCT03090191|183109418|SUPERIORITY||Vaccine efficacy|11.1|||||TWO_SIDED|98.2|-110.7|62.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model.|||62.5|-110.7|
91608331|NCT03090191|183109419|SUPERIORITY|||||||0.0172|||||||Wilcoxon Rank Sum Test (2-sided)|||||||0.0172
91608332|NCT03090191|183109420|SUPERIORITY||Ratio of proportions|0.0|||||TWO_SIDED|98.2|0.0|0.81||||||||0.81|0.00|
91608333|NCT03090191|183109421|SUPERIORITY||Vaccine efficacy|-69.3|||||TWO_SIDED|98.2|-1533.1|75.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of recurrent CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||75.6|-1533.1|
91652908|NCT00101582|183198335|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.9715||||0.0463||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0463
91608334|NCT03090191|183109422|SUPERIORITY||Vaccine efficacy|14.9|||||TWO_SIDED|98.2|-74.6|58.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model|||58.5|-74.6|
91608335|NCT03090191|183109423|SUPERIORITY||Vaccine efficacy|-102.4|||||TWO_SIDED|98.2|-1770.1|67.2|||||VE = 100\*(1 - IRR), where IRR= the calculated ratio of recurrent CDI incidence between the Clostridium difficile vaccine group and the placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||67.2|-1770.1|
91608336|NCT03090191|183109424|SUPERIORITY||Vaccine efficacy|12.0|||||TWO_SIDED|98.2|-246.7|78.5|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||78.5|-246.7|
91608337|NCT01521845|183109460|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
91608338|NCT01521845|183109461|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91608339|NCT01521845|183109462|SUPERIORITY_OR_OTHER|||||||1||95.0|||||not comparable|||||||1
91608340|NCT03047005|183109463|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.07|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.07
91608341|NCT03047005|183109464|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.01|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.01
91608342|NCT02586805|183109471|OTHER||% change in mean rate (vs placebo)|-75.609|||<|0.001|TWO_SIDED|95.0|-84.65|-61.243||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.243|-84.650|<0.001
91608343|NCT02586805|183109471|OTHER||% change in mean rate (vs placebo)|-73.271|||<|0.001|TWO_SIDED|95.0|-82.379|-59.456||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-59.456|-82.379|<0.001
91608344|NCT02586805|183109471|OTHER||% change in mean rate (vs placebo)|-86.921|||<|0.001|TWO_SIDED|95.0|-92.828|-76.15||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-76.150|-92.828|<0.001
91608345|NCT02586805|183109472|OTHER||% change in mean rate (vs placebo)|-80.842|||<|0.001|TWO_SIDED|95.0|-89.169|-66.114||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-66.114|-89.169|<0.001
91608346|NCT02586805|183109472|OTHER||% change in mean rate (vs placebo)|-74.169|||<|0.001|TWO_SIDED|95.0|-83.733|-58.983||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-58.983|-83.733|<0.001
91608347|NCT02586805|183109472|OTHER||% change in mean rate (vs placebo)|-87.299|||<|0.001|TWO_SIDED|95.0|-93.494|-75.204||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-75.204|-93.494|<0.001
91608348|NCT02586805|183109473|OTHER||% change in mean rate (vs placebo)|-70.497|||<|0.001|TWO_SIDED|95.0|-82.696|-49.699||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-49.699|-82.696|<0.001
91608349|NCT02586805|183109473|OTHER||% change in mean rate (vs placebo)|-73.285|||<|0.001|TWO_SIDED|95.0|-84.316|-54.496||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-54.496|-84.316|<0.001
91608350|NCT02586805|183109473|OTHER||% change in mean rate (vs placebo)|-83.394|||<|0.001|TWO_SIDED|95.0|-91.618|-67.099||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-67.099|-91.618|<0.001
91608351|NCT02586805|183109474|OTHER||% change in mean rate (vs placebo)|-77.622|||<|0.001|TWO_SIDED|95.0|-86.253|-63.572||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-63.572|-86.253|<0.001
91652909|NCT00101582|183198335|SUPERIORITY_OR_OTHER|||||||0.2314||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2314
91652910|NCT00101582|183198336|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.2548||||0.0712||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0712
91652911|NCT00101582|183198336|SUPERIORITY_OR_OTHER|||||||0.2849||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2849
91652912|NCT00101582|183198337|SUPERIORITY_OR_OTHER||Chi-Square Statistic|1.3901||||0.2384||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.2384
91652913|NCT00101582|183198337|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
91652914|NCT00101582|183198338|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9039||||0.3417||95.0||||Generalized Cochran-Mantel-Haenszel test for general association|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.3417
91652915|NCT00101582|183198338|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
91652916|NCT00101582|183198339|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0027||||0.9587||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.9587
91652917|NCT00101582|183198339|SUPERIORITY_OR_OTHER|||||||0.9587||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.9587
91652918|NCT01907087|183198340|OTHER|Inference is by an exact binomial test of the null hypothesis H0: Prob(response) \<= 0.50 vs. the alternative hypothesis H1: Prob(response) \> 0.50, where Prob(response) denotes the population probability of a response. The confidence interval is an exact interval with significance level α=0.05.|Proportion of responders|0.87||||0.0002|TWO_SIDED|95.0|0.66|0.97|||exact binomial test|||"Responder Analysis using ITT Population: Proportion of Subjects without an Unreversed Two-point Decline or Score of 0 in ML Scale Score at 48 Weeks.~A 'response' is defined as the absence of an unreversed two-point decline or score of 0 in the 0-to-6 point CLN2 score at 48 weeks."||0.97|0.66|0.0002
91652919|NCT01907087|183198340|OTHER|"Subject rate of decline per 48 weeks is estimated: (baseline CLN2 score - last CLN2 score)/(time elapsed in units of 48 weeks).~P-value computed as a two-sided t-test for the hypothesis H0: Rate=2.0 points lost/48 weeks vs. H1: Rate not equal 2.0 points lost/48 weeks."|Slope|0.4|STANDARD_DEVIATION|0.809|<|0.0001|TWO_SIDED|95.0|0.05|0.75|||t-test, 2 sided|||Slopes Analysis using ITT Population: Estimated Rate of Decline (300 mg Dosing Period).||0.75|0.05|<0.0001
91652920|NCT01919190|183198346|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|TWO_SIDED||||||ANCOVA|||||||>0.8
91652921|NCT01919190|183198347|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||Mixed Models Analysis|||||||0.0456
91652922|NCT00135707|183198397|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.42|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.||1.25|0.91|0.42
91652923|NCT00135707|183198398|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.79|TWO_SIDED|95.0|0.85|1.24|||Chi-squared|||||1.24|0.85|0.79
91652924|NCT00135707|183198399|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.35|TWO_SIDED|95.0|0.47|1.31|||Chi-squared|||||1.31|0.47|0.35
91652925|NCT00135707|183198400|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.16|TWO_SIDED|95.0|0.39|1.17|||Chi-squared|||||1.17|0.39|0.16
91652926|NCT00135707|183198401|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.34|TWO_SIDED|95.0|0.25|1.63|||Chi-squared|||||1.63|0.25|0.34
91652927|NCT00135707|183198402|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.49||||0.11|TWO_SIDED|95.0|0.78|7.94|||Chi-squared|||||7.94|0.78|0.11
91652928|NCT00135707|183198403|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.57|TWO_SIDED|95.0|0.39|1.68|||Chi-squared|||||1.68|0.39|0.57
91652929|NCT00135707|183198404|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.18|TWO_SIDED|95.0|0.89|1.9|||Chi-squared|||||1.90|0.89|0.18
91652930|NCT00135707|183198405|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.48|2.46|||Chi-squared|||||2.46|0.48|0.84
91652931|NCT00135707|183198406|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.24|||Chi-squared|||||1.24|0.93|0.33
91652932|NCT00135707|183198407|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.004|TWO_SIDED|95.0|1.03|1.17|||Chi-squared|||||1.17|1.03|0.004
91652933|NCT00135707|183198408|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.25|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||||1.21|0.95|0.25
91652934|NCT00135707|183198409|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.15||95.0|0.47|1.12|||Chi-squared|||||1.12|0.47|0.15
91652935|NCT00135707|183198410|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.51|TWO_SIDED|95.0|0.32|1.77|||Chi-squared|||||1.77|0.32|0.51
91652936|NCT00135707|183198411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.33|TWO_SIDED|95.0|0.82|1.79|||Chi-squared|||||1.79|0.82|0.33
91652937|NCT00135707|183198412|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.74|TWO_SIDED|95.0|0.75|1.22|||Chi-squared|||||1.22|0.75|0.74
91652938|NCT00135707|183198413|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.12|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.40|0.12
91608352|NCT02586805|183109474|OTHER||% change in mean rate (vs placebo)|-75.377|||<|0.001|TWO_SIDED|95.0|-84.115|-61.833||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.833|-84.115|<0.001
91608353|NCT02586805|183109474|OTHER||% change in mean rate (vs placebo)|-89.008|||<|0.001|TWO_SIDED|95.0|-94.325|-78.707||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-78.707|-94.325|<0.001
91608354|NCT02750410|183109492|SUPERIORITY||LS mean percent difference|-1.5|||<|0.001|TWO_SIDED|95.0|-1.73|-1.28|||Mixed Models Analysis|||||-1.28|-1.73|<0.001
91608355|NCT02750410|183109493|SUPERIORITY||Odds Ratio (OR)|0.117||||0.003|TWO_SIDED|95.0|0.028|0.479|||Regression, Logistic|||analysis was based on repeated measures logistic regression||0.479|0.028|0.003
91608356|NCT02750410|183109494|SUPERIORITY||LS mean difference|-30.14|||<|0.001|TWO_SIDED|95.0|-41.37|-18.91|||Mixed Models Analysis|||||-18.91|-41.37|<0.001
91608357|NCT02750410|183109495|SUPERIORITY||LS mean difference|-26.59|||<|0.001|TWO_SIDED|95.0|-36.39|-16.78|||t-test, 2 sided|||Prebreakfast BG||-16.78|-36.39|<0.001
91608358|NCT02750410|183109495|SUPERIORITY||LS mean difference|-45.38|||<|0.001|TWO_SIDED|95.0|-61.77|-29.0|||t-test, 2 sided|||Breakfast 2-hour PPBG||-29.00|-61.77|<0.001
91608359|NCT02750410|183109495|SUPERIORITY||LS mean difference|-36.82|||<|0.001|TWO_SIDED|95.0|-49.2|-24.45|||t-test, 2 sided|||Prelunch BG||-24.45|-49.20|<0.001
91608360|NCT02750410|183109495|SUPERIORITY||LS mean difference|-50.16|||<|0.001|TWO_SIDED|95.0|-67.85|-32.46|||t-test, 2 sided|||Lunch 2-hour PPBG||-32.46|-67.85|<0.001
91608361|NCT02750410|183109495|SUPERIORITY||LS mean difference|-31.27|||<|0.001|TWO_SIDED|95.0|-44.05|-18.48|||t-test, 2 sided|||Predinner BG||-18.48|-44.05|<0.001
91608362|NCT02750410|183109495|SUPERIORITY||LS mean difference|-34.97|||<|0.001|TWO_SIDED|95.0|-52.55|-17.38|||t-test, 2 sided|||Dinner 2-hour PPBG||-17.38|-52.55|<0.001
91652939|NCT00135707|183198414|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.35|TWO_SIDED|95.0|0.97|1.11|||Chi-squared|||||1.11|0.97|0.35
91608363|NCT02750410|183109495|SUPERIORITY||LS mean difference|-41.45|||<|0.001|TWO_SIDED|95.0|-58.81|-24.09|||t-test, 2 sided|||Bedtime BG||-24.09|-58.81|<0.001
91608364|NCT02750410|183109496|SUPERIORITY||LS mean difference|0.1||||0.776|TWO_SIDED|95.0|-0.59|0.78|||Mixed Models Analysis|||||0.78|-0.59|0.776
91608365|NCT03215277|183109507|SUPERIORITY||Mean Posterior Difference|0.23|||||TWO_SIDED|95.0|-0.14|0.6|||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.||0.60|-0.14|
91608366|NCT03215277|183109507|SUPERIORITY||PR[Diff > 0%](%)|88.4|||||TWO_SIDED||||||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr\[Diff\>0%\](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group.||||
91608367|NCT01364467|183109600|OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
91608368|NCT01364467|183109601|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
91608369|NCT01364467|183109601|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
91608370|NCT03815175|183109613|NON_INFERIORITY|"H0: Death/(MI\[1m-DAPT\]) - Death/(MI \[XIENCE V USA\]) ≥ δ HA: Death/MI(\[1m-DAPT\]) - Death/(MI \[XIENCE V USA: NCT00676520\]) \< δ~Where δ is the non-inferiority margin. The test will be carried out with a one-sided significance level of 0.025 and a non-inferiority margin (δ) of 2.5%."||||||0.0005|||||||Farrington-Manning method|||||||0.0005
91608371|NCT03815175|183109616|SUPERIORITY|"H0: B (1m-DAPT) - B (XIENCE V USA) ≥ 0 HA: B (1m-DAPT) - B (XIENCE V USA: NCT00676520) \< 0~B 1m-DAPT and B XIENCE V USA are bleeding rates (BARC type 2-5) between 1-month and 6-month follow-up for the pooled 1-month DAPT arm and XIENCE V USA historical control, respectively."||||||0.1888|||||||Farrington and Manning method|||||||0.1888
91608372|NCT03577990|183109653|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|0.125||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
91652940|NCT00135707|183198416|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.05|TWO_SIDED|95.0|0.08|1.08|||Chi-squared|||||1.08|0.08|0.05
91652941|NCT00135707|183198417|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.05|TWO_SIDED|95.0|0.45|1.01|||Chi-squared|||||1.01|0.45|0.05
91652942|NCT00135707|183198418|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.65
91652943|NCT00135707|183198419|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
91652944|NCT00135707|183198420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.63|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||\<37 weeks' gestation||1.09|0.87|0.63
91608373|NCT03577990|183109654|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|1250.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
91608374|NCT03577990|183109655|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|300.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
91608375|NCT03577990|183109657|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|500.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
91608376|NCT01672892|183109699|SUPERIORITY|||||||0.0476|||||||t-test, 1 sided|||Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.||||0.0476
91608377|NCT01672892|183109700|SUPERIORITY|||||||0.4338|||||||Binomial test of proportions|2-sided significance level = 0.05||||||0.4338
91608378|NCT01672892|183109701|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 3 of RT||||0.04
91652945|NCT00135707|183198420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.86||||0.16|TWO_SIDED|95.0|0.69|1.06|||Chi-squared|||\<32 weeks' gestation||1.06|0.69|0.16
91652946|NCT00135707|183198421|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.53|TWO_SIDED|95.0|0.72|1.19|||Chi-squared|||||1.19|0.72|0.53
91652947|NCT00135707|183198422|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
91652948|NCT00135707|183198423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.27|||Chi-squared|||||1.27|0.79|0.98
91652949|NCT00135707|183198424|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Chi-squared|||||1.07|0.81|0.32
91652950|NCT00135707|183198425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.58|TWO_SIDED|95.0|0.92|1.15|||Chi-squared|||||1.15|0.92|0.58
91608379|NCT01672892|183109701|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 5 of RT||||0.03
91608380|NCT01672892|183109701|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided significance level of 0.05||4-6 weeks post-RT||||0.41
91608381|NCT01672892|183109702|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-G total score - 5 weeks||||0.54
91652951|NCT00135707|183198426|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.75|TWO_SIDED|95.0|0.83|1.3|||Chi-squared|||||1.30|0.83|0.75
91652952|NCT00135707|183198427|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.78|TWO_SIDED|95.0|0.29|2.54|||Chi-squared|||||2.54|0.29|0.78
91652953|NCT00135707|183198428|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.76|2.23|||Chi-squared|||||2.23|0.76|0.34
91652954|NCT00135707|183198429|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.41|TWO_SIDED|95.0|0.32|1.6|||Chi-squared|||||1.60|0.32|0.41
91652955|NCT00135707|183198430|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.62|TWO_SIDED|95.0|0.61|2.3|||Chi-squared|||||2.30|0.61|0.62
91652956|NCT00135707|183198431|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.56|TWO_SIDED|95.0|0.49|1.48|||Chi-squared|||||1.48|0.49|0.56
91652957|NCT00135707|183198432|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
91652958|NCT00135707|183198433|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|95.0|0.82|1.26|||Chi-squared|||||1.26|0.82|0.86
91652959|NCT00135707|183198434|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.32|TWO_SIDED|95.0|0.89|1.42|||Chi-squared|||||1.42|0.89|0.32
91652960|NCT01681030|183198435|SUPERIORITY_OR_OTHER||Proportion|0.923|||||TWO_SIDED|95.0|0.64|0.998|||||CI for EVARREST Group|||0.998|0.640|
91652961|NCT01681030|183198435|SUPERIORITY_OR_OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.133|0.59|||||CI for Topical Hemostat group|||0.590|0.133|
91652962|NCT01681030|183198435|SUPERIORITY_OR_OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.167|0.766|||||CI for Standard of Care group|||0.766|0.167|
91652963|NCT01176448|183198489|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.||||||0.77||95.0||||Appropriately powered, this study failed to reject the null hypothesis that fraxel achieves a similar cosmetic result at 3 months when compared to dermabrasion.|Wilcoxon (Mann-Whitney)|||efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group's scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categories||||.77
91652964|NCT02584140|183198522|OTHER||||||<|0.001||||||The P-Value for Week 4 was \<0.001; The P-Value for Week 12 was 0.005; The P-Value for Week 24 was 0.029; The P-Value for Week 36 was 0.008; The P-Value for Week 48 was 0.03.|Wilcoxon (Mann-Whitney)|||||||<0.001
91652965|NCT01006707|183198588|SUPERIORITY_OR_OTHER|||||||0.042|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.042
91608382|NCT01672892|183109702|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|FACT-G total score - 4-6 weeks post RT||FACT-G total score - 4-6 weeks post RT||||0.72
91608383|NCT01672892|183109702|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 5 weeks||||0.01
91608384|NCT01672892|183109702|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 4-6 weeks post RT||||0.45
91652966|NCT01006707|183198589|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.322
91652967|NCT01006707|183198590|SUPERIORITY_OR_OTHER|||||||0.261|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.261
91652968|NCT00358826|183198630|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
91652969|NCT00358826|183198630|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
91652970|NCT00358826|183198630|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
91652971|NCT00358826|183198631|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
91652972|NCT00358826|183198631|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
91652973|NCT00358826|183198631|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
91652974|NCT00358826|183198632|SUPERIORITY_OR_OTHER|||||||0.656||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.656
91652975|NCT00358826|183198632|SUPERIORITY_OR_OTHER|||||||0.863||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.863
91652976|NCT00358826|183198632|SUPERIORITY_OR_OTHER|||||||0.996||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.996
91652977|NCT00358826|183198633|SUPERIORITY_OR_OTHER|||||||0.331||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.331
91652978|NCT00358826|183198633|SUPERIORITY_OR_OTHER|||||||0.606||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.606
91652979|NCT00358826|183198633|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANOVA|||||||<0.001
91652980|NCT00358826|183198634|SUPERIORITY_OR_OTHER|||||||0.22||||||Dunnett test compared with Placebo|ANCOVA|||||||0.22
91652981|NCT00358826|183198634|SUPERIORITY_OR_OTHER||||||<|0.005||||||Dunnett test compared with Placebo|ANCOVA|||||||<0.005
91608385|NCT01672892|183109702|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 5 weeks||||0.03
91608386|NCT01672892|183109702|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 4-6 weeks post RT||||0.9
91608387|NCT01672892|183109702|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 5 weeks||||0.55
91608388|NCT01672892|183109702|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 4-6 weeks post RT||||0.35
91608389|NCT01672892|183109702|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 5 weeks||||0.66
91608390|NCT01672892|183109702|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 4-6 weeks post RT||||0.09
91608391|NCT01672892|183109702|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 5 weeks||||0.66
91608392|NCT01672892|183109702|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 4-6 weeks post RT||||0.35
91608393|NCT01672892|183109703|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|2-sided significance level = 0.05||5 weeks||||0.61
91608394|NCT01672892|183109703|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|2-sided significance level = 0.05||4-6 weeks post-RT||||0.67
91608395|NCT01672892|183109704|SUPERIORITY|||||||0.81|||||||Gray's test|Two-sided significance level = 0.05||||||0.81
91608396|NCT01672892|183109705|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.21|TWO_SIDED|95.0|0.82|2.35|||Log Rank|Two-side significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||2.35|0.82|0.21
91608397|NCT01672892|183109706|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.53|TWO_SIDED|95.0|0.32|1.79|||Log Rank|Two-sided significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||1.79|0.32|0.53
91608398|NCT01672892|183109709|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Baseline||||<0.0001
91788261|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.07|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-91.32|-74.83||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-74.83|-91.32|<0.001
91608399|NCT01672892|183109709|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Week 5||||<0.0001
91608400|NCT01672892|183109710|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at baseline||||<0.0001
91608401|NCT01672892|183109710|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at week 5||||<0.0001
91608402|NCT01672892|183109710|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at baseline||||<0.0001
91608403|NCT01672892|183109710|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at week 5||||<0.0001
91608404|NCT01672892|183109711|OTHER||||||<|0.0001|||||||Paired t-test|||Bowel domain||||<0.0001
91652982|NCT00358826|183198634|SUPERIORITY_OR_OTHER|||||||0.6||||||Dunnett test compared with Placebo|ANCOVA|||||||0.60
91652983|NCT00358826|183198635|SUPERIORITY_OR_OTHER|||||||0.92||||||Dunnett test compared with Placebo|ANCOVA|||||||0.92
91652984|NCT00358826|183198635|SUPERIORITY_OR_OTHER|||||||0.96||||||Dunnett test compared with Placebo|ANCOVA|||||||0.96
91652985|NCT00358826|183198635|SUPERIORITY_OR_OTHER|||||||1||||||Dunnett test compared with Placebo|ANCOVA|||||||1.00
91652986|NCT00358826|183198636|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
91652987|NCT00358826|183198636|SUPERIORITY_OR_OTHER|||||||0.11||||||Dunnett test compared with Placebo|ANCOVA|||||||0.11
91608405|NCT01672892|183109711|OTHER||||||<|0.0001|||||||Paired t-test|||Urinary domain||||<0.0001
91608406|NCT03815292|183109738|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
91608407|NCT03815292|183109739|SUPERIORITY|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0445
91608408|NCT03815292|183109740|SUPERIORITY|||||||0.0345|||||||Fisher Exact|||||||0.0345
91608409|NCT03815292|183109741|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.04
91608410|NCT03815292|183109742|SUPERIORITY|||||||0.0016|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0016
91608411|NCT03815292|183109743|SUPERIORITY|||||||0.0054|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0054
91608412|NCT03815292|183109743|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.78
91608413|NCT03815292|183109743|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0042
91608414|NCT03815292|183109744|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.77
91608415|NCT03815292|183109745|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.0118
91608416|NCT03815292|183109746|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.058
91608417|NCT01584024|183109754|SUPERIORITY||||||=|0.003|||||||McNemar|||||||=0.003
91608418|NCT01584024|183109755|SUPERIORITY||||||=|0.17|||||||McNemar|||||||=0.17
91608419|NCT04893265|183109818|SUPERIORITY||Mean Difference (Net)|0.0854|STANDARD_ERROR_OF_MEAN|0.1122||0.4471|TWO_SIDED|95.0|-0.1352|0.306|||Mixed Models Analysis|||||0.3060|-0.1352|0.4471
91608420|NCT04893265|183109819|SUPERIORITY||Odds Ratio (OR)|0.8378|||<|0.05|TWO_SIDED|95.0|0.4284|1.6385|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||1.6385|0.4284|<0.05
91608421|NCT04893265|183109820|SUPERIORITY||Odds Ratio (OR)|1.4306|||<|0.05|TWO_SIDED|95.0|0.6166|3.3192|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||3.3192|0.6166|<0.05
91608422|NCT04893265|183109821|SUPERIORITY||Mean Difference (Final Values)|0.08661|STANDARD_ERROR_OF_MEAN|0.08125|||TWO_SIDED|95.0|-0.07311|0.2463|||||Adjusted for Demographics, COVID Cases Per 100,000 Population, Test Access, Social Network, Knowledge, and Test Value with random intercepts for Dyad and Individual|||0.2463|-0.07311|
91608423|NCT01142323|183109835|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0|||||Matched pairs|||||||0.008
91608424|NCT01142323|183109836|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91608425|NCT00893789|183109844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8336||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.8336
91608426|NCT00893789|183109844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0514||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0514
91652988|NCT00358826|183198636|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
91652989|NCT00283686|183198637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.52|TWO_SIDED|95.0|-0.8|5.0||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Test for differences between treatment groups over time.||||5.0|-0.8|0.52
91652990|NCT00283686|183198637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.006|TWO_SIDED|95.0|-1.6|-0.2||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Testing differences between blood pressure groups over time||||-0.2|-1.6|0.006
91788262|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-94.51|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|90.0|-102.92|-86.1||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-86.10|-102.92|<0.001
91710032|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.441|TWO_SIDED|95.0|-13.6|6.0|||Mixed Models Analysis|||9:15pm||6.0|-13.6|0.4410
91710033|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1||||0.1046|TWO_SIDED|95.0|-17.9|1.7|||Mixed Models Analysis|||9:15pm||1.7|-17.9|0.1046
91710034|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.6467|TWO_SIDED|95.0|-12.0|7.5|||Mixed Models Analysis|||9:15pm||7.5|-12.0|0.6467
91710035|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4||||0.1971|TWO_SIDED|95.0|-16.2|3.4|||Mixed Models Analysis|||9:15pm||3.4|-16.2|0.1971
91788263|NCT01375075|183456958|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.68|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|90.0|-76.2|-59.16||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-59.16|-76.20|<0.001
91608427|NCT00893789|183109844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0010
91608428|NCT00893789|183109845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7884||95.0|||||Pearson's chi-squared|||||||0.7884
91608429|NCT00893789|183109845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2359||95.0|||||Pearson's chi-squared|||||||0.2359
91608430|NCT00893789|183109845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||Pearson's chi-squared|||||||0.4401
91608431|NCT01575548|183109873|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.54|1.29|||Log Rank|Stratified log rank test was used to compare DFS between the two arms.||||1.29|0.54|0.21
91608432|NCT01244737|183109917|OTHER||Pearson correlation co-efficient|0.8|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||This is a diagnostic test of FLT uptake (SUV max) as a predictor of cellular proliferation (MIB) and is performed as an analysis of correlation using each evaluable participant enrolled in either Arm 1 (New Diagnosis) or Arm 2 (Possible recurrent tumor). The groups (Arm 1 and Arm 2) provide pathways for enrollment. Correlation between the two measures of outcome (SUV max and MIB) is evaluated.||||< 0.001
91608433|NCT01244737|183109920|OTHER|Paired T-test to assess change in FLT uptake (SUV max) with chemotherapy.||||||0.04||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.04
91608434|NCT00736229|183109921|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison for the difference in Median glucose values during steady state across all three groups.|Kruskal-Wallis|||Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.||||<0.001
91608435|NCT00736229|183109921|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison of Median Glucose Values between Exenatide and Intensive Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||<0.001
91608436|NCT00736229|183109921|SUPERIORITY_OR_OTHER|||||||0.15||||||Comparison of Median Glucose Values between Exenatide and Moderate Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||0.15
91608437|NCT00736229|183109922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.||||<0.001
91608438|NCT00736229|183109922|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||0.80
91608439|NCT00736229|183109922|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||<0.001
91608440|NCT00356915|183109932|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||P-Value from a Cochran-Mantel-Haenszel test, . The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
91710036|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.9052|TWO_SIDED|95.0|-10.4|9.2|||Mixed Models Analysis|||9:15pm||9.2|-10.4|0.9052
91710037|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.242|TWO_SIDED|95.0|-15.6|4.0|||Mixed Models Analysis|||9:15pm||4.0|-15.6|0.2420
91710038|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.7||||0.0001|TWO_SIDED|95.0|-25.1|-8.3|||Mixed Models Analysis|||11:15pm||-8.3|-25.1|0.0001
91710039|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.4321|TWO_SIDED|95.0|-5.0|11.6|||Mixed Models Analysis|||11:15pm||11.6|-5.0|0.4321
91710040|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.4|||<|0.0001|TWO_SIDED|95.0|-26.7|-10.1|||Mixed Models Analysis|||11:15pm||-10.1|-26.7|<0.0001
91710041|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.6999|TWO_SIDED|95.0|-6.7|9.9|||Mixed Models Analysis|||11:15pm||9.9|-6.7|0.6999
91710042|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|||<|0.0001|TWO_SIDED|95.0|-26.4|-9.8|||Mixed Models Analysis|||11:15pm||-9.8|-26.4|<0.0001
91710043|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.6566|TWO_SIDED|95.0|-6.4|10.2|||Mixed Models Analysis|||11:15pm||10.2|-6.4|0.6566
91710044|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.3|-11.7|||Mixed Models Analysis|||11:15pm||-11.7|-28.3|<0.0001
91710045|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.2|||<|0.0001|TWO_SIDED|95.0|-36.1|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.1|<0.0001
91710046|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7824|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7824
91710047|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.0|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.0|<0.0001
91608441|NCT00356915|183109933|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. No p-value was calculated for this endpoint.|Wald's CI|0.56|||||ONE_SIDED|97.5|-4.3||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||Comparison between the 2 itraconazole groups was based on lower bound of the 97.5% confidence interval for the difference. The non-inferiority analysis was restricted to the active dosing groups.|||-4.3|
91608442|NCT00356915|183109934|NON_INFERIORITY_OR_EQUIVALENCE|The assumption was that the Complete Cure rate at week 52 was 35% for the active dosing groups, a sample size of 552 ITT subjects per active group would have had a 93% power for testing the proportion of subjects with Complete Cure. These computations assumed a non inferiority margin of 10% and a one-sided significance level of 0.025. Power computations were performed using nQuery Advisor, Version 5.0.|Mean Difference (Final Values)|10.0|||<|0.001|ONE_SIDED|97.5|-1.1||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||The test for demonstrating non-inferiority was based on a margin of 10%. Thus, non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. The non-inferiority analysis was restricted to the active dosing groups.|||-1.1|< 0.001
91608443|NCT00356915|183109935|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
91608444|NCT02371629|183109936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.0169||0.051|TWO_SIDED|95.0|0.0|0.066|||Mixed model for repeated measure (MMRM)|||||0.066|0.000|0.051
91608445|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-2.0|||||TWO_SIDED|95.0|-7.65|2.88||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||2.88|-7.65|
91608446|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-14.9|||||TWO_SIDED|95.0|-26.4|-3.21||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.21|-26.40|
91608447|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|0.06|||||TWO_SIDED|95.0|-5.84|6.05||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.05|-5.84|
91608448|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|2.06|||||TWO_SIDED|95.0|-1.71|7.25||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||7.25|-1.71|
91608449|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|2.12|||||TWO_SIDED|95.0|-4.09|8.89||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||8.89|-4.09|
91608450|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
91608451|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-6.92|||||TWO_SIDED|95.0|-16.19|1.89||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.89|-16.19|
91608452|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-1.94|||||TWO_SIDED|95.0|-9.07|4.86||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.86|-9.07|
91608453|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-4.86|||||TWO_SIDED|95.0|-14.4|4.39||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.39|-14.40|
91608454|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-19.0|||||TWO_SIDED|95.0|-30.1|-7.16||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-7.16|-30.10|
91608455|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|-12.19|||||TWO_SIDED|95.0|-21.66|-3.26||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.26|-21.66|
91608456|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
91608457|NCT01193335|183109951|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
91608458|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.62|1.02||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.62|
91608459|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.56|||||TWO_SIDED|95.0|0.38|0.82||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.38|
91608460|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.74|||||TWO_SIDED|95.0|0.59|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.59|
91608461|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.92|1.65||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.65|0.92|
91608462|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.25||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.25|0.80|
91608463|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.58|
91608464|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.47|
91608465|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.55|0.89||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.89|0.55|
91608466|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.19|0.77|
91608467|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
91608468|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.45|0.82||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.45|
91608469|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.71|||||TWO_SIDED|95.0|0.57|0.88||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.57|
91608470|NCT01193335|183109952|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.68|
91608471|NCT01193335|183109961|SUPERIORITY_OR_OTHER|||||||0.668|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.668
91788264|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.38|2.21||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.21|1.38|<0.001
91608472|NCT01193335|183109961|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.051
91608473|NCT01193335|183109962|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.704
91608474|NCT01193335|183109962|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
91608475|NCT01193335|183109963|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.531
91608476|NCT01193335|183109963|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
91608477|NCT01193335|183109964|SUPERIORITY_OR_OTHER|||||||0.183|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.183
91608478|NCT01193335|183109964|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.357
91608479|NCT01193335|183109965|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.794
91608480|NCT01193335|183109965|SUPERIORITY_OR_OTHER|||||||0.782|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.782
91608481|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR Ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.14|0.63|
91608482|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.24|||||TWO_SIDED|95.0|0.95|1.62||||||Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.62|0.95|
91652991|NCT00283686|183198638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.52|TWO_SIDED|95.0|-0.6|0.3||adjusting for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences in treatment over time (differences in slopes over time).||||0.3|-0.6|0.52
91608483|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.47|0.96|
91608484|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|0.97|||||TWO_SIDED|95.0|0.74|1.26||||||Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.26|0.74|
91608485|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|0.8|||||TWO_SIDED|95.0|0.63|1.02||||||Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.02|0.63|
91608486|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|0.88|||||TWO_SIDED|95.0|0.65|1.19||||||Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.19|0.65|
91608487|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.33|0.74|
91608488|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|0.84|||||TWO_SIDED|95.0|0.64|1.11||||||Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.11|0.64|
91652992|NCT00283686|183198638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.55|TWO_SIDED|95.0|-0.3|0.6||adjusted for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences between groups over time (differences in slopes over time)||||0.6|-0.3|0.55
91652993|NCT00283686|183198639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.57|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||1.9|-3.3|0.57
91652994|NCT00283686|183198639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.5|-3.4|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-3.4|-8.5|<0.0001
91652995|NCT00283686|183198640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.18|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.18
91652996|NCT00283686|183198640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.19|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.19
91652997|NCT00283686|183198641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.088||||0.58|TWO_SIDED|95.0|-0.4|0.22|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing the annual change over time between ACE/ARB and ACE alone|||0.22|-0.40|0.58
91788265|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|2.65|3.48||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.48|2.65|<0.001
91652998|NCT00283686|183198641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0002|TWO_SIDED|95.0|-0.91|-0.29|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups|||-0.29|-0.91|0.0002
91608489|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.46|||||TWO_SIDED|95.0|1.03|2.05||||||Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||2.05|1.03|
91608490|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.81|1.24||||||Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.24|0.81|
91608491|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82||||||Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.82|1.02|
91608492|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|0.96|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.18|0.78|
91608493|NCT01193335|183109966|SUPERIORITY_OR_OTHER||GMFR ratio|1.15|||||TWO_SIDED|95.0|0.88|1.52||||||Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.52|0.88|
91608494|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91608495|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|-2.33|||||TWO_SIDED|95.0|-8.15|1.96||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.96|-8.15|
91608496|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91608497|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91652999|NCT00283686|183198642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.97||||0.29|TWO_SIDED|95.0|-2.55|8.5|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change in mL/min/1.73 m\^2 for ACE+ARB compared to ACE alone|||8.50|-2.55|0.29
91653000|NCT00283686|183198642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.73|TWO_SIDED|95.0|-4.54|6.5|||Mixed Models Analysis|adjusting for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change mL/min/1.73 m\^2 between low and standard blood pressure groups|||6.50|-4.54|0.73
91653001|NCT00283686|183198643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0228|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|adjusting for age, sex, race, and clinical site||||0.95|0.53|0.0228
91653002|NCT00283686|183198643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.59|TWO_SIDED|95.0|0.7|1.22|||Regression, Cox|adjusting for age, sex, race, and clinical site||||1.22|0.70|0.59
91653003|NCT00283686|183198644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016||||0.87|TWO_SIDED|95.0|-0.19|0.17|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.17|-0.19|0.87
91653004|NCT00283686|183198644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.14|TWO_SIDED|95.0|-0.046|0.31|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.31|-0.046|0.14
91710048|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7867|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7867
91653005|NCT00283686|183198645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.0221|TWO_SIDED|95.0|0.036|0.46|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.46|0.036|0.0221
91710049|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.4|-15.6|||Mixed Models Analysis|||1:15am||-15.6|-37.4|<0.0001
91788266|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|3.04|3.88||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.88|3.04|<0.001
91653006|NCT00283686|183198645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23||||0.0339|TWO_SIDED|95.0|-0.44|-0.018|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-0.018|-0.44|0.0339
91653007|NCT00543439|183198646|SUPERIORITY||Ratio of arithmetic means|0.03||||0.002|ONE_SIDED|95.0||0.08|||Paired t-test|||Ratio of the arithmetic means of the ABR for OD cohort: OD therapy to OD cohort: RP therapy 25 IU/kg was calculated. One-sided 95% CI for this ratio was reported.||0.08||0.0020
91653008|NCT00543439|183198647|EQUIVALENCE|90% 2-sided CI for the mean difference in ABRs for the 2 prophylaxis regimens for ITT participants was constructed using the t distribution with n-1 degrees of freedom (n equals the number of participants) to assess the equivalence of the 2 regimens. Equivalence was demonstrated and the null hypothesis rejected if the limits of the 90% CI fell wholly within the interval of (-4, 4) bleeds per year.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|90.0|0.03|2.22||||||||2.22|0.03|
91653009|NCT01484028|183198682|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.05 LogMAR was used.|Least-square mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.0034|||TWO_SIDED|95.0|0.004|0.017|||Mixed Models Analysis|||The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.||0.017|0.004|
91653010|NCT02400710|183198685|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
91653011|NCT02400710|183198686|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||.05
91653012|NCT02826603|183198721|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.72|2.84|||Regression, Logistic|||||2.84|1.72|<0.0001
91653013|NCT02826603|183198722|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.63|2.72|||Regression, Logistic|||||2.72|1.63|<0.0001
91653014|NCT02826603|183198723|SUPERIORITY||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.89|3.62|||Regression, Logistic|||||3.62|1.89|<0.0001
91653015|NCT02826603|183198724|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.65|4.71|||Regression, Logistic|||||4.71|2.65|<0.0001
91653016|NCT02826603|183198725|SUPERIORITY||Odds Ratio (OR)|2.33|||<|0.0001|TWO_SIDED|95.0|1.8|3.01|||Regression, Logistic|||||3.01|1.80|<0.0001
91653017|NCT02826603|183198726|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.96|3.37|||Regression, Logistic|||||3.37|1.96|<0.0001
91653018|NCT02826603|183198727|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.89|3.31|||Regression, Logistic|||||3.31|1.89|<0.0001
91653019|NCT02826603|183198728|SUPERIORITY||Odds Ratio (OR)|2.86|||<|0.0001|TWO_SIDED|95.0|1.96|4.17|||Regression, Logistic|||||4.17|1.96|<0.0001
91653020|NCT02826603|183198729|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.19|3.71|||Regression, Logistic|||||3.71|2.19|<0.0001
91653021|NCT02826603|183198730|SUPERIORITY||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.41|2.41|||Regression, Logistic|||||2.41|1.41|<0.0001
91710050|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.6029|TWO_SIDED|95.0|-13.7|8.0|||Mixed Models Analysis|||1:15am||8.0|-13.7|0.6029
91710051|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.5|-12.8|||Mixed Models Analysis|||1:15am||-12.8|-34.5|<0.0001
91710052|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-24.1|||Mixed Models Analysis|||3:15am||-24.1|-50.1|<0.0001
91710053|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.8684|TWO_SIDED|95.0|-11.9|14.1|||Mixed Models Analysis|||3:15am||14.1|-11.9|0.8684
91710054|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.3|||<|0.0001|TWO_SIDED|95.0|-66.3|-40.3|||Mixed Models Analysis|||3:15am||-40.3|-66.3|<0.0001
91710055|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.1||||0.0228|TWO_SIDED|95.0|-28.1|-2.1|||Mixed Models Analysis|||3:15am||-2.1|-28.1|0.0228
91710056|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|||<|0.0001|TWO_SIDED|95.0|-53.0|-27.0|||Mixed Models Analysis|||3:15am||-27.0|-53.0|<0.0001
91608498|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|1.15|||||TWO_SIDED|95.0|-3.13|6.24||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.24|-3.13|
91608499|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91608500|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|-1.16|||||TWO_SIDED|95.0|-6.32|3.1||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||3.10|-6.32|
91608501|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91653022|NCT00905489|183198731|SUPERIORITY_OR_OTHER||Ratio NVP XR: NVP IR (%)|91.2|STANDARD_ERROR_OF_MEAN|1.05||0.008|TWO_SIDED|90.0|83.47|99.64|||Mixed Models Analysis|Adjusted geometric means are estimated from the mixed model for intra-individual comparison.||||99.64|83.47|0.0080
91653023|NCT03558997|183198749|SUPERIORITY||Least Square (LS) Mean Difference|4.73||||0.7185|TWO_SIDED|95.0|-21.023|30.487|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.487|-21.023|0.7185
91608502|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|-8.72|||||TWO_SIDED|95.0|-21.93|4.42||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.42|-21.93|
91608503|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91653024|NCT03558997|183198750|SUPERIORITY||Least Square (LS) Mean Difference|0.3||||0.5438|TWO_SIDED|95.0|-0.661|1.254|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||1.254|-0.661|0.5438
91653025|NCT03558997|183198751|SUPERIORITY||Least Square (LS) Mean Difference|0.03||||0.9559|TWO_SIDED|95.0|-0.877|0.928|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.928|-0.877|0.9559
91608504|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91608505|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91608506|NCT01193335|183109968|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
91608507|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.97|0.60|
91608508|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.66|0.39|
91608509|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.51|0.8||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.80|0.51|
91788267|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.81|2.63||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.81|<0.001
91788268|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.4|2.36||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.36|1.40|<0.001
91788269|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.99|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.51|3.47||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.47|2.51|<0.001
91608510|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.12|0.66|
91608511|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.32|0.85|
91608512|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.92||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.92|0.58|
91608513|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.43|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.43|
91608514|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.20|0.77|
91608515|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.87||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.41|
91608516|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.56|
91608517|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.70|0.41|
91608518|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.71|1.03||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.71|
91608519|NCT01193335|183109970|SUPERIORITY_OR_OTHER||GMC Ratio|0.55|||||TWO_SIDED|95.0|0.42|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.42|
91608520|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.51|0.82||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.51|
91608521|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.47|0.79||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.47|
91608522|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.61|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.61|
91608523|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.66|
91608524|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.08|0.66|
91608525|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
91608526|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.79||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.46|
91608527|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.64|1.03||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.64|
91788270|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|3.42|4.41||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.41|3.42|<0.001
91608528|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.73|1.15||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.73|
91608529|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.58|
91608530|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.57|
91608531|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.00|0.69|
91608532|NCT01193335|183109971|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.49|0.81||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.49|
91608533|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.04||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.63|
91608534|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
91608535|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.84|0.46|
91608536|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.61|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.12|0.61|
91608537|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.5|||||TWO_SIDED|95.0|0.37|0.67||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.67|0.37|
91608538|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
91608539|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.47|||||TWO_SIDED|95.0|0.35|0.64||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.64|0.35|
91608540|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.61|0.94||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.61|
91608541|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.39|
91608542|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.52|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.52|
91608543|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
91608544|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.67|1.02||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.67|
91788271|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.56|2.52||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.52|1.56|<0.001
91788272|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.34|2.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.31|1.34|<0.001
91608545|NCT01193335|183109972|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.36|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.36|
91608546|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.03||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.61|
91608547|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.76||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.38|
91608548|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.54|1.03||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.54|
91608549|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.17||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.51|
91608550|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.4|0.78||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.40|
91608551|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.29|0.71||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.71|0.29|
91608552|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.38|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.38|
91608553|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.63|
91608554|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.39|1.11||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.11|0.39|
91608555|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.92||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.50|
91788273|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.34|3.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.31|2.34|<0.001
91788274|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|2.74|3.73||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.73|2.74|<0.001
91788275|NCT01375075|183456959|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.65|2.63||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.65|<0.001
91608556|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.47|0.95||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.95|0.47|
91608557|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.13|0.70|
91608558|NCT01193335|183109973|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.37|0.78||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.37|
91608559|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.81||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.81|0.99|
91710057|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7852|TWO_SIDED|95.0|-14.8|11.2|||Mixed Models Analysis|||3:15am||11.2|-14.8|0.7852
91710058|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.2|-25.2|||Mixed Models Analysis|||3:15am||-25.2|-51.2|<0.0001
91710059|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.3|-25.1|||Mixed Models Analysis|||5:15am||-25.1|-51.3|<0.0001
91710060|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9||||0.5528|TWO_SIDED|95.0|-9.1|17.0|||Mixed Models Analysis|||5:15am||17.0|-9.1|0.5528
91710061|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.9|||<|0.0001|TWO_SIDED|95.0|-67.0|-40.9|||Mixed Models Analysis|||5:15am||-40.9|-67.0|<0.0001
91788276|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|74.23|STANDARD_ERROR_OF_MEAN|12.59|<|0.001|TWO_SIDED|90.0|53.38|95.07||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||95.07|53.38|<0.001
91608560|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.59|2.2||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.20|0.59|
91608561|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.93||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.93|0.26|
91608562|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.98||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.98|0.80|
91608563|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.01|2.0||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.00|1.01|
91710062|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.8||||0.0747|TWO_SIDED|95.0|-24.9|1.2|||Mixed Models Analysis|||5:15am||1.2|-24.9|0.0747
91710063|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.2|||<|0.0001|TWO_SIDED|95.0|-62.2|-36.1|||Mixed Models Analysis|||5:15am||-36.1|-62.2|<0.0001
91710064|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1||||0.2868|TWO_SIDED|95.0|-20.1|6.0|||Mixed Models Analysis|||5:15am||6.0|-20.1|0.2868
91710065|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.1|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.1|||Mixed Models Analysis|||5:15am||-29.1|-55.2|<0.0001
91710066|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.6||||0.0007|TWO_SIDED|95.0|-59.1|-16.2|||Mixed Models Analysis|||7:15am||-16.2|-59.1|0.0007
91710067|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.9089|TWO_SIDED|95.0|-22.7|20.2|||Mixed Models Analysis|||7:15am||20.2|-22.7|0.9089
91710068|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.9|||<|0.0001|TWO_SIDED|95.0|-74.3|-31.4|||Mixed Models Analysis|||7:15am||-31.4|-74.3|<0.0001
91710069|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5||||0.1307|TWO_SIDED|95.0|-37.9|5.0|||Mixed Models Analysis|||7:15am||5.0|-37.9|0.1307
91710070|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.3||||0.0011|TWO_SIDED|95.0|-57.7|-14.8|||Mixed Models Analysis|||7:15am||-14.8|-57.7|0.0011
91710071|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9903|TWO_SIDED|95.0|-21.3|21.6|||Mixed Models Analysis|||7:15am||21.6|-21.3|0.9903
91710072|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.4||||0.001|TWO_SIDED|95.0|-57.8|-14.9|||Mixed Models Analysis|||7:15am||-14.9|-57.8|0.0010
91710073|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4||||0.1655|TWO_SIDED|95.0|-51.7|9.0|||Mixed Models Analysis|||9:15am||9.0|-51.7|0.1655
91710074|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.8975|TWO_SIDED|95.0|-32.4|28.5|||Mixed Models Analysis|||9:15am||28.5|-32.4|0.8975
91710075|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.2||||0.0199|TWO_SIDED|95.0|-66.5|-5.8|||Mixed Models Analysis|||9:15am||-5.8|-66.5|0.0199
91710076|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8||||0.2785|TWO_SIDED|95.0|-47.2|13.7|||Mixed Models Analysis|||9:15am||13.7|-47.2|0.2785
91710077|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3||||0.5048|TWO_SIDED|95.0|-40.6|20.1|||Mixed Models Analysis|||9:15am||20.1|-40.6|0.5048
91788277|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|115.36|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|90.0|94.58|136.14||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||136.14|94.58|<0.001
91788278|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|135.57|STANDARD_ERROR_OF_MEAN|12.72|<|0.001|TWO_SIDED|90.0|114.5|156.63||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||156.63|114.50|<0.001
91788279|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.47|STANDARD_ERROR_OF_MEAN|4.85||0.002|TWO_SIDED|90.0|-23.5|-7.43||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-7.43|-23.50|0.002
91788280|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.37|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|90.0|-31.37|-15.38||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-15.38|-31.37|<0.001
91608564|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.82|1.89||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.89|0.82|
91608565|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.99||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.99|0.80|
91608566|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.56|
91653026|NCT03558997|183198752|SUPERIORITY||Least Square (LS) Mean Difference|7.25||||0.5416|TWO_SIDED|95.0|-16.028|30.53|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.530|-16.028|0.5416
91653027|NCT03558997|183198753|SUPERIORITY||Least Square (LS) Mean Difference|-0.94||||0.0414|TWO_SIDED|95.0|-1.848|-0.037|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.037|-1.848|0.0414
91653028|NCT03558997|183198754|SUPERIORITY||Least Square (LS) Mean Difference|-30.45||||0.0108|TWO_SIDED|95.0|-53.874|-7.034|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-7.034|-53.874|0.0108
91653029|NCT03558997|183198755|SUPERIORITY||Median Difference|0.665||||0.1449|TWO_SIDED|95.0|-0.77|3.21|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||3.2100|-0.770|0.1449
91653030|NCT03558997|183198756|SUPERIORITY||Median Difference|335.3||||0.1231|TWO_SIDED|95.0|-551.47|1746.55|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1746.55|-551.47|0.1231
91788281|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.19|STANDARD_ERROR_OF_MEAN|4.91|<|0.001|TWO_SIDED|90.0|-30.32|-14.06||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-14.06|-30.32|<0.001
91653031|NCT03558997|183198757|SUPERIORITY||Median Difference|-13.325|||<|0.0001|TWO_SIDED|95.0|-23.94|-8.36|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-8.3600|-23.9400|<0.0001
91653032|NCT03558997|183198758|SUPERIORITY||Median Difference|-134.6|||<|0.0001|TWO_SIDED|95.0|-205.51|-94.98|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-94.98|-205.51|<0.0001
91653033|NCT03558997|183198759|SUPERIORITY||Median Difference|0.84|||<|0.0001|TWO_SIDED|95.0|0.45|1.27|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1.2700|0.4500|<0.0001
91653034|NCT02473991|183198768|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.||||<0.01
91788282|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|103.25|STANDARD_ERROR_OF_MEAN|12.64|<|0.001|TWO_SIDED|90.0|82.32|124.18||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||124.18|82.32|<0.001
91608567|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.41||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.41|0.83|
91608568|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.36|0.94||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.36|
91608569|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.88|1.68||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.68|0.88|
91608570|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.39||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.39|0.78|
91608571|NCT01193335|183109979|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.89|1.51||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.51|0.89|
91608572|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.37|1.44||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.37|
91608573|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.37|1.71||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.71|0.37|
91608574|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.76|3.12||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.12|0.76|
91608575|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.33|1.17||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.33|
91608576|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.24|1.55||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.55|0.24|
91608577|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.97|1.77||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.77|0.97|
91608578|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.35|1.46||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.46|0.35|
91608579|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|1.0|1.6||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.60|1.00|
91608580|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.68|1.33||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.33|0.68|
91653035|NCT02473991|183198769|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.||||<0.01
91788283|NCT01375075|183456960|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.63|STANDARD_ERROR_OF_MEAN|4.88||0.003|TWO_SIDED|90.0|-22.72|-6.55||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-6.55|-22.72|0.003
91653036|NCT03123549|183198770|SUPERIORITY|||||||0.017|||||||t-test, 1 sided|||||||0.017
91653037|NCT04567615|183198787|SUPERIORITY||Strata adjusted difference in ORR|-2.7|||||TWO_SIDED|95.0|-10.7|5.3|||||Difference in ORR of Treatment B over ORR Treatment A|||5.3|-10.7|
91653038|NCT04567615|183198790|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR Treatment A|||1.33|0.75|
91653039|NCT04567615|183198791|SUPERIORITY||Strata adjusted difference in ORR|-0.9|||||TWO_SIDED|95.0|-9.2|7.4|||||Difference in ORR of Treatment B over ORR Treatment A|||7.4|-9.2|
91653040|NCT04567615|183198794|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR of Treatment A|||1.33|0.75|
91788284|NCT03050775|183456974|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
91608581|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.31||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.82|
91608582|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.24|1.04||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.24|
91608583|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.58|2.53||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.53|0.58|
91653041|NCT04567615|183198795|SUPERIORITY||Cox proportional hazard model|1.05|||||TWO_SIDED|95.0|0.74|1.49|||||HR of Treatment B over HR of Treatment A|||1.49|0.74|
91653042|NCT04680052|183198819|SUPERIORITY||Hazard Ratio (HR)|0.434|||<|0.0001|TWO_SIDED|95.0|0.324|0.58|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.580|0.324|<0.0001
91653043|NCT04680052|183198821|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.383|0.653|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.653|0.383|<0.0001
91653044|NCT04680052|183198822|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0286|TWO_SIDED|95.0|1.04|2.13|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.13|1.04|0.0286
91653045|NCT04680052|183198824|SUPERIORITY||Hazard Ratio (HR)|0.587||||0.1061|TWO_SIDED|95.0|0.306|1.128|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.128|0.306|0.1061
91653046|NCT04680052|183198825|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.0221|TWO_SIDED|95.0|1.06|2.03|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.03|1.06|0.0221
91788285|NCT03050775|183456974|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.358|TWO_SIDED|95.0|-0.085|0.237|||ANCOVA|||||0.237|-0.085|0.358
91608584|NCT01193335|183109980|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.52|1.37||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.52|
91608585|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.45|0.97||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.45|
91608586|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.54|1.4||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.40|0.54|
91653047|NCT04680052|183198826|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.4||||0.4093|TWO_SIDED|95.0|0.61|3.33|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.33|0.61|0.4093
91653048|NCT04680052|183198827|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.2874|TWO_SIDED|95.0|0.69|3.47|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.47|0.69|0.2874
91653049|NCT04680052|183198828|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0014|TWO_SIDED|95.0|1.3|3.02|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.02|1.30|0.0014
91653050|NCT04680052|183198829|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.74|||Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.74|1.29|0.0009
91653051|NCT04680052|183198831|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.473|||<|0.0001|TWO_SIDED|95.0|0.33|0.678|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.678|0.330|<0.0001
91653052|NCT04680052|183198833|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.55||||0.0003|TWO_SIDED|95.0|0.397|0.763|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.763|0.397|0.0003
91653053|NCT04680052|183198835|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.85||||0.5837|TWO_SIDED|95.0|0.476|1.519|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.519|0.476|0.5837
91653054|NCT04680052|183198837|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.294|0.563|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.563|0.294|<0.0001
91653055|NCT04680052|183198839|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.357|0.647|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.647|0.357|<0.0001
91788286|NCT03050775|183456975|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.823|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||\~30 minutes post-induction||0.2|-0.3|0.823
91608587|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.31||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.41|
91608588|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.14||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.54|
91653056|NCT04680052|183198840|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.43|3.43|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.43|1.43|0.0003
91788287|NCT03050775|183456975|SUPERIORITY||Median Difference (Final Values)|0.0||||0.853|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||\~60 minutes post-induction. Data was obtained from 33 subjects in the treatment group.||0.3|-0.2|0.853
91608589|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.87||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.34|
91608590|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.31|1.1||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.10|0.31|
91608591|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.4|1.01||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.01|0.40|
91608592|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.38|0.81||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.38|
91608593|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.17||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.76|
91608594|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.91||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.45|
91608595|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.47|0.85||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.85|0.47|
91608596|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.15||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.74|
91653057|NCT04680052|183198841|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0005|TWO_SIDED|95.0|1.33|2.86|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.86|1.33|0.0005
91653058|NCT04680052|183198843|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.461|||<|0.0001|TWO_SIDED|95.0|0.312|0.681|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.681|0.312|<0.0001
91653059|NCT04680052|183198845|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|1.192||||0.7469|TWO_SIDED|95.0|0.409|3.475|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||3.475|0.409|0.7469
91710078|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1||||0.5533|TWO_SIDED|95.0|-21.3|39.6|||Mixed Models Analysis|||9:15am||39.6|-21.3|0.5533
91710079|NCT01096680|183312461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.4||||0.2098|TWO_SIDED|95.0|-49.9|11.1|||Mixed Models Analysis|||9:15am||11.1|-49.9|0.2098
91710080|NCT04485637|183312496|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.05|TWO_SIDED|95.0|1.0|2.79|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||2.79|1.00|=0.05
91788288|NCT03050775|183456975|SUPERIORITY||Median Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||\~120 minutes post-induction||0.2|-0.2|0.986
91788289|NCT03050775|183456976|SUPERIORITY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.5|5.9|||Fisher Exact|||Post-operative shivering observed||5.9|0.5|0.540
91788290|NCT03050775|183456977|SUPERIORITY||Median Difference (Final Values)|0.0||||0.672|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.672
91788291|NCT03050775|183456978|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.571|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||Data was obtained from 32 subjects in the treatment group.||0.1|-0.2|0.571
91788292|NCT03050775|183456979|SUPERIORITY||Odds Ratio (OR)|1.4||||0.619|TWO_SIDED|95.0|0.5|3.7|||Fisher Exact|||||3.7|0.5|0.619
91608597|NCT01193335|183109981|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
91608598|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.35|2.05||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.05|0.35|
91608599|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.41|2.63||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.63|0.41|
91608600|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.22|1.53||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.22|
91653060|NCT01073020|183198857|SUPERIORITY||proportion|0.08||||0.6|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (LAGB Grp) who achieved the primary outcome.|||||0.60
91788293|NCT03050775|183456980|SUPERIORITY||Median Difference (Final Values)|75.0||||0.404|TWO_SIDED|95.0|-100.0|250.0|||Wilcoxon (Mann-Whitney)|||||250|-100|0.404
91788294|NCT03603509|183456982|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: HAI Day 28 - HAI Day 0 for Fluad = HAI Day 28 - HAI Day 0 for Fluzone Alternative Hypothesis: HAI Day 28 - HAI Day 0 for Fluad NE HAI Day 28 - HAI Day 0 for Fluzone||||0.062
91608601|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.38|1.44||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.38|
91608602|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.1|0.76||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.10|
91608603|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.25|1.3||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.30|0.25|
91608604|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.11|0.65||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.65|0.11|
91608605|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.32||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.32|0.81|
91653061|NCT01073020|183198857|SUPERIORITY||proportion|0.42||||0.005|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (RYGB Grp) who achieved the primary outcome.|||||0.005
91653062|NCT01073020|183198858|SUPERIORITY||Mean Difference (Net)|1.0||||0.33|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline HbA1c.|||||0.33
91710081|NCT04485637|183312496|SUPERIORITY||Odds Ratio (OR)|1.66|||=|0.05|TWO_SIDED|95.0|1.0|2.76|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||2.76|1.00|=0.05
91788295|NCT03603509|183456991|SUPERIORITY|null hypothesis: CMV Fluad sample index = CMV Fluzone sample index at Baseline alternate hypothesis: CMV Fluad sample index not equal to CMV Fluzone sample index at Baseline||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91788296|NCT01727700|183457008|SUPERIORITY_OR_OTHER||Treatment difference|-6.26||||0.002|TWO_SIDED|95.0|-10.18|-2.34||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation \[SD\] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-2.34|-10.18|0.0020
91608606|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.37||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.56|
91608607|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.51|1.23||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.23|0.51|
91608608|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|0.86||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.17|
91608609|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.64|1.97||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.97|0.64|
91653063|NCT01073020|183198858|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline HbA1c.|||||<0.001
91653064|NCT01073020|183198859|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline BMI.|||||<0.001
91710082|NCT04485637|183312497|SUPERIORITY|Enhanced table \> Basic table|Odds Ratio (OR)|1.52|||=|0.29|TWO_SIDED|95.0|0.71|3.26|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||3.26|0.71|=0.29
91608610|NCT01193335|183109982|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.27|0.97||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.27|
91608611|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.33|2.37||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.37|0.33|
91608612|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.37|3.07||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.07|0.37|
91608613|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|0.57|5.36||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||5.36|0.57|
91653065|NCT01073020|183198859|SUPERIORITY||Mean Difference (Net)|4.6|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline BMI.|||||<0.001
91653066|NCT01073020|183198860|SUPERIORITY||Mean Difference (Net)|1.5||||0.81|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline CHD risk.|||||0.81
91653067|NCT01073020|183198860|SUPERIORITY||Mean Difference (Net)|2.6||||0.009|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline CHD risk.|||||0.009
91710083|NCT04485637|183312497|SUPERIORITY|Enhanced graph \> Basic table|Odds Ratio (OR)|0.96|||=|0.9|TWO_SIDED|95.0|0.48|1.93|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||1.93|0.48|=0.90
91710084|NCT04485637|183312498|SUPERIORITY||Unst|-0.14|||=|0.13|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||0.04|-0.32|=0.13
91710085|NCT04485637|183312498|SUPERIORITY||Unstandardized B|-0.14|||=|0.12|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||0.04|-0.32|=0.12
91710086|NCT04485637|183312499|SUPERIORITY|Enhanced table \> Basic table|Unstandardized B|-0.08|||=|0.33|TWO_SIDED|95.0|-0.25|0.08|||Regression, Linear|||||0.08|-0.25|=0.33
91710087|NCT04485637|183312499|SUPERIORITY||Unstandardized B|-0.09|||=|0.29|TWO_SIDED|95.0|-0.26|0.08|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||||0.08|-0.26|=0.29
91710088|NCT02182830|183312500|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint|Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.18|-0.38|||Mixed Models Analysis||Empagliflozin minus Placebo|"MMRM model : HbA1c baseline, treatment, renal function, pre-treatment with metformin, visit, visit by treatment interaction, and HbA1c baseline by treatment interaction. Treatment, renal function, pre-treatment with metformin, visit, and visit by treatment interaction were fixed classification effects, and HbA1c baseline was a linear covariate. The interaction visit by HbA1c baseline interaction was based on the linear covariate HbA1c baseline."||-0.38|-1.18|0.0002
91710089|NCT02182830|183312501|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.21|STANDARD_ERROR_OF_MEAN|2.04||0.0117|TWO_SIDED|95.0|-9.24|-1.18|||ANCOVA||Empagliflozin minus Placebo|"change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-1.18|-9.24|0.0117
91710090|NCT02182830|183312502|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.99|STANDARD_ERROR_OF_MEAN|2.62||0.0237|TWO_SIDED|95.0|-11.16|-0.81|||ANCOVA||Empagliflozin minus Placebo|"ANCOVA mode:~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-0.81|-11.16|0.0237
91710091|NCT02182830|183312503|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.59||0.0382|TWO_SIDED|95.0|-2.39|-0.07|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||-0.07|-2.39|0.0382
91791054|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91608614|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.38|2.07||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.07|0.38|
91608615|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.18|1.21||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.21|0.18|
91608616|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.53||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.27|
91608617|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|1.15||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.17|
91608618|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.31||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.96|
91608619|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.14||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.41|
91608620|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.49|0.92||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.49|
91710092|NCT02182830|183312504|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.59||0.1215|TWO_SIDED|95.0|-9.16|1.09|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||1.09|-9.16|0.1215
91710093|NCT02182830|183312505|SUPERIORITY||Adjusted mean difference|-8.39|STANDARD_ERROR_OF_MEAN|2.69||0.0025|TWO_SIDED|95.0|-13.74|-3.04|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-3.04|-13.74|0.0025
91710094|NCT02182830|183312506|SUPERIORITY||Adjusted mean difference|-3.43|STANDARD_ERROR_OF_MEAN|1.25||0.0069|TWO_SIDED|95.0|-5.9|-0.96|||ANCOVA||Empagliflozin minus Placebo|The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.||-0.96|-5.90|0.0069
91791055|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.256||0.335|TWO_SIDED|95.0|-0.751|0.257||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.257|-0.751|0.335
91608621|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.16|1.03||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.16|
91608622|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.48||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.48|0.27|
91608623|NCT01193335|183109983|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.22|0.91||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.22|
91653068|NCT00094302|183198865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.14|TWO_SIDED|95.0|0.77|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.77|0.14
91653069|NCT00094302|183198866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.35|TWO_SIDED|95.0|0.73|1.12||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event."||1.12|0.73|0.35
91653070|NCT00094302|183198867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.48|TWO_SIDED|95.0|0.14|2.5||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event."||2.50|0.14|0.48
91608624|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.33|5.99||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.99|-6.33|
91653071|NCT00094302|183198868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event"||0.99|0.69|0.04
91608625|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|-4.89|||||TWO_SIDED|95.0|-16.87|5.39||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.39|-16.87|
91608626|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|-6.85|||||TWO_SIDED|95.0|-24.28|10.67||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.67|-24.28|
91608627|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|3.03|||||TWO_SIDED|95.0|-3.68|10.57||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.57|-3.68|
91608628|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.57|5.88||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.88|-6.57|
91608629|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|3.45|||||TWO_SIDED|95.0|-3.32|11.91||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.91|-3.32|
91608630|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|1.52|||||TWO_SIDED|95.0|-6.73|9.94||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.94|-6.73|
91653072|NCT00094302|183198869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.29|TWO_SIDED|95.0|0.77|1.08||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject's last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.||1.08|0.77|0.29
91653073|NCT00094302|183198870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.28|TWO_SIDED|95.0|0.8|1.06||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.06|0.80|0.28
91710095|NCT02182830|183312507|SUPERIORITY||Adjusted mean difference|-4.91|STANDARD_ERROR_OF_MEAN|1.74||0.0058|TWO_SIDED|95.0|-8.35|-1.46|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.46|-8.35|0.0058
91788297|NCT01727700|183457008|SUPERIORITY_OR_OTHER||Treatment difference|-9.85|||<|0.0001|TWO_SIDED|95.0|-13.84|-5.86||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-5.86|-13.84|<0.0001
91788298|NCT01727700|183457009|SUPERIORITY_OR_OTHER||Treatment difference|-1.03||||0.0001|TWO_SIDED|95.0|-1.54|-0.52||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.52|-1.54|0.0001
91788299|NCT01727700|183457009|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.0002|TWO_SIDED|95.0|-1.54|-0.49||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.49|-1.54|0.0002
91608631|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Perecent Difference|-10.82|||||TWO_SIDED|95.0|-25.51|4.34||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.34|-25.51|
91608632|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|4.65|||||TWO_SIDED|95.0|0.04|11.48||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.48|0.04|
91608633|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|-16.06|||||TWO_SIDED|95.0|-29.15|-2.6||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.60|-29.15|
91608634|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|2.27|||||TWO_SIDED|95.0|-1.96|7.97||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.97|-1.96|
91608635|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|-2.15|||||TWO_SIDED|95.0|-7.55|2.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.10|-7.55|
91608636|NCT01193335|183109984|SUPERIORITY_OR_OTHER||Percent Difference|-1.09|||||TWO_SIDED|95.0|-5.96|3.18||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.18|-5.96|
91608637|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-9.08|||||TWO_SIDED|95.0|-25.11|7.49||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.49|-25.11|
91608638|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-5.39|||||TWO_SIDED|95.0|-21.03|10.4||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.40|-21.03|
91608639|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|6.53|||||TWO_SIDED|95.0|-7.16|21.16||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||21.16|-7.16|
91608640|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-7.88|||||TWO_SIDED|95.0|-20.28|3.35||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.35|-20.28|
91608641|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-10.73|||||TWO_SIDED|95.0|-29.01|8.11||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.11|-29.01|
91608642|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|7.11|||||TWO_SIDED|95.0|-1.52|17.65||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.65|-1.52|
91608643|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-13.37|||||TWO_SIDED|95.0|-29.57|3.31||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.31|-29.57|
91608644|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|8.09|||||TWO_SIDED|95.0|-0.52|17.81||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.81|-0.52|
91608645|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-7.38|||||TWO_SIDED|95.0|-22.86|8.29||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.29|-22.86|
91608646|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|0.51|||||TWO_SIDED|95.0|-8.82|10.08||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.08|-8.82|
91608647|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-20.19|||||TWO_SIDED|95.0|-35.45|-3.95||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.95|-35.45|
91608648|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||||TWO_SIDED|95.0|-8.5|19.06||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.06|-8.50|
91608649|NCT01193335|183109985|SUPERIORITY_OR_OTHER||Percent Difference|-3.14|||||TWO_SIDED|95.0|-17.51|11.13||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.13|-17.51|
91653074|NCT00094302|183198871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.15|TWO_SIDED|95.0|0.76|1.04||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.76|0.15
91653075|NCT00094302|183198872|SUPERIORITY_OR_OTHER||incidence rate ratio|0.75||||0.03|TWO_SIDED|95.0|0.58|0.97||No covariate adjustment|Negative binomial regression||Spironolactone compared to Placebo|There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.||0.97|0.58|0.03
91710096|NCT02182830|183312508|SUPERIORITY||Adjusted mean difference|-7.43|STANDARD_ERROR_OF_MEAN|2.5||0.0036|TWO_SIDED|95.0|-12.37|-2.48|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-2.48|-12.37|0.0036
91710097|NCT02182830|183312509|SUPERIORITY||Adjusted mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.56||0.2402|TWO_SIDED|95.0|-4.93|1.25|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||1.25|-4.93|0.2402
91653076|NCT00094302|183198873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.38|0.67|0.82
91653077|NCT00094302|183198874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.64|1.83||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events."||1.83|0.64|0.76
91710098|NCT02182830|183312510|SUPERIORITY||Adjusted mean difference|-4.25|STANDARD_ERROR_OF_MEAN|1.49||0.0053|TWO_SIDED|95.0|-7.21|-1.29|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.29|-7.21|0.0053
91710099|NCT04399538|183312511|SUPERIORITY||Difference in least square (LS) mean|-52.36|||<|0.0001||80.0|-60.07|-43.17|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-43.17|-60.07|<0.0001
91788300|NCT01727700|183457010|SUPERIORITY_OR_OTHER||Treatment difference|-13.26||||0.0017|TWO_SIDED|95.0|-21.43|-5.08||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-5.08|-21.43|0.0017
91653078|NCT00094302|183198875|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.02||||0.94|TWO_SIDED|95.0|0.69|1.5||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events."||1.50|0.69|0.94
91710100|NCT04399538|183312511|SUPERIORITY||Difference in LS mean|-56.58|||<|0.0001||80.0|-63.88|-47.8|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-47.80|-63.88|<0.0001
91710101|NCT04399538|183312511|SUPERIORITY||Difference in LS mean|-58.8|||<|0.0001||80.0|-65.66|-50.57|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100\*(RC-1). 80% CI was calculated based on difference in LS mean between groups.||-50.57|-65.66|<0.0001
91710102|NCT04399538|183312511|SUPERIORITY||Difference in LS mean|-45.8||||0.0003||80.0|-55.86|-33.46|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-33.46|-55.86|0.0003
91788301|NCT01727700|183457010|SUPERIORITY_OR_OTHER||Treatment difference|-19.37|||<|0.0001|TWO_SIDED|95.0|-27.7|-11.04||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-11.04|-27.70|<0.0001
91653079|NCT00094302|183198876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.71|1.42||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events."||1.42|0.71|0.98
91653080|NCT00094302|183198877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.73|TWO_SIDED|95.0|0.65|1.35||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events."||1.35|0.65|0.73
91653081|NCT00094302|183198878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49|||<|0.01|TWO_SIDED|95.0|1.18|1.87||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee."||1.87|1.18|<0.01
91653082|NCT00094302|183198879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.35|0.66|0.75
91653083|NCT00094302|183198880|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
91653084|NCT00094302|183198880|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
91710103|NCT03268005|183312538|NON_INFERIORITY|The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.|Treatment difference|-0.04||||0.31|TWO_SIDED|95.0|-0.11|0.03|||ANOVA||Faster aspart-NovoRapid|Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.||0.03|-0.11|0.310
91710104|NCT00492232|183312596|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.71||||0.484||95.0|0.27|1.85||Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using the logistic regression analysis adjusted for effects of treatment and pooled center.||||1.85|0.27|0.484
91788302|NCT01727700|183457011|SUPERIORITY_OR_OTHER||Treatment difference|-0.8||||0.001|TWO_SIDED|95.0|-1.27|-0.33||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.33|-1.27|0.0010
91653085|NCT00094302|183198881|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.87
91653086|NCT00094302|183198881|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.16
91710105|NCT00492232|183312597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.946||95.0|-6.23|5.81||P-values are from t-tests of the analysis of covariance (ANCOVA) model for the difference in least squares (LS) means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||5.81|-6.23|0.946
91788303|NCT01727700|183457011|SUPERIORITY_OR_OTHER||MMRM|-0.92||||0.0002|TWO_SIDED|95.0|-1.41|-0.44||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.44|-1.41|0.0002
91788304|NCT01727700|183457012|SUPERIORITY_OR_OTHER||Response ratio|1.36||||0.0835|TWO_SIDED|95.0|0.98|1.88||P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||1.88|0.98|0.0835
91788305|NCT01727700|183457012|SUPERIORITY_OR_OTHER||Response ratio|1.61||||0.0014|TWO_SIDED|95.0|1.2|2.16||P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||2.16|1.20|0.0014
91710106|NCT00492232|183312598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.901||95.0|-5.31|6.03||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.03|-5.31|0.901
91710107|NCT00492232|183312599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.538||95.0|-4.32|8.23||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||8.23|-4.32|0.538
91710108|NCT00492232|183312600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.517||95.0|-9.09|4.6||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||4.60|-9.09|0.517
91710109|NCT00492232|183312601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965||95.0|-6.28|6.56||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.56|-6.28|0.965
91710110|NCT00492232|183312602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.617||95.0|-0.27|0.45||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.45|-0.27|0.617
91710111|NCT00492232|183312603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.541||95.0|-0.39|0.74||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.74|-0.39|0.541
91710112|NCT00492232|183312604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.163||95.0|-0.23|1.33||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.33|-0.23|0.163
91608650|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.59|5.89||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.89|-5.59|
91608651|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.08|||||TWO_SIDED|95.0|-6.81|7.37||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.37|-6.81|
91608652|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|-1.55|||||TWO_SIDED|95.0|-10.87|7.44||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.44|-10.87|
91608653|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.94|5.94||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.94|-5.94|
91608654|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|-1.61|||||TWO_SIDED|95.0|-8.66|4.25||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.25|-8.66|
91608655|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|-6.64|||||TWO_SIDED|95.0|-17.93|3.56||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.56|-17.93|
91608656|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.05|||||TWO_SIDED|95.0|-6.74|7.04||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.04|-6.74|
91608657|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|-6.48|||||TWO_SIDED|95.0|-16.37|2.75||||||Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.75|-16.37|
91608658|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|1.27|||||TWO_SIDED|95.0|-3.37|6.85||||||Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.85|-3.37|
91608659|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|-1.34|||||TWO_SIDED|95.0|-8.36|5.14||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.14|-8.36|
91608660|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.73|5.04||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.04|-4.73|
91608661|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
91608662|NCT01193335|183109986|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
91608663|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-7.5|||||TWO_SIDED|95.0|-24.5|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-24.5|
91608664|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-5.9|||||TWO_SIDED|95.0|-23.6|11.8||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.8|-23.6|
91710113|NCT00492232|183312605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.757||95.0|-0.79|1.08||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.08|-0.79|0.757
91788306|NCT01727700|183457013|SUPERIORITY_OR_OTHER||Discontinuation ratio|1.16||||0.9187|TWO_SIDED|95.0|0.19|7.05||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||7.05|0.19|0.9187
91608665|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-10.7|||||TWO_SIDED|95.0|-27.6|6.0||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.0|-27.6|
91608666|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-17.0|8.4||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.4|-17.0|
91608667|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-23.0|||||TWO_SIDED|95.0|-40.0|-4.9||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.9|-40.0|
91608668|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-11.9|||||TWO_SIDED|95.0|-27.4|3.4||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.4|-27.4|
91608669|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-28.2|||||TWO_SIDED|95.0|-43.9|-11.0||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-11.0|-43.9|
91608670|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-0.3|||||TWO_SIDED|95.0|-10.9|10.3||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.3|-10.9|
91608671|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-1.2|||||TWO_SIDED|95.0|-17.5|15.1||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.1|-17.5|
91608672|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-10.6|||||TWO_SIDED|95.0|-25.3|4.5||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.5|-25.3|
91608673|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-18.6|||||TWO_SIDED|95.0|-33.3|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-33.3|
91608674|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-7.1|13.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.1|-7.1|
91608675|NCT01193335|183109987|SUPERIORITY_OR_OTHER||Percent Difference|-18.5|||||TWO_SIDED|95.0|-33.7|-2.8||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.8|-33.7|
91608676|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-7.9|||||TWO_SIDED|95.0|-25.2|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-25.2|
91608677|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|0.3|||||TWO_SIDED|95.0|-18.5|19.0||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.0|-18.5|
91608678|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|7.3|||||TWO_SIDED|95.0|-12.0|26.2||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||26.2|-12.0|
91608679|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-2.8|||||TWO_SIDED|95.0|-19.1|13.3||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.3|-19.1|
91608680|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-17.9|||||TWO_SIDED|95.0|-34.6|-0.3||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-0.3|-34.6|
91608681|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-20.6|12.1||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.1|-20.6|
91608682|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-21.1|||||TWO_SIDED|95.0|-37.8|-3.2||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.2|-37.8|
91608683|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|5.6|||||TWO_SIDED|95.0|-2.7|15.2||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.2|-2.7|
91608684|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-5.1|||||TWO_SIDED|95.0|-22.0|12.0||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.0|-22.0|
91608685|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-14.4|||||TWO_SIDED|95.0|-26.7|-2.4||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.4|-26.7|
91608686|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-20.4|||||TWO_SIDED|95.0|-36.8|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-36.8|
91608687|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent Difference|-11.3|||||TWO_SIDED|95.0|-26.4|4.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.1|-26.4|
91788307|NCT01727700|183457013|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.9576||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.9576
91710114|NCT00492232|183312606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.82||95.0|-0.93|1.17||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.17|-0.93|0.820
91710115|NCT00492232|183312608|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.01||||0.284||95.0|0.55|7.34||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||7.34|0.55|0.284
91788308|NCT01727700|183457013|SUPERIORITY_OR_OTHER||Discontinuation ratio|4.06||||0.0132|TWO_SIDED|95.0|1.1|14.95||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||14.95|1.10|0.0132
91788309|NCT01727700|183457013|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.51||||0.0278||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.0278
91788310|NCT02484859|183457018|SUPERIORITY||||||>|0.69|||||||Wilcoxon (Mann-Whitney)|||Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.||||>0.69
91788311|NCT02484859|183457019|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91788312|NCT02484859|183457020|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
91788313|NCT02484859|183457021|SUPERIORITY|||||||0.05|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.||||0.05
91788314|NCT02484859|183457021|SUPERIORITY|||||||0.55|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.||||0.55
91608688|NCT01193335|183109988|SUPERIORITY_OR_OTHER||Percent difference|-21.6|||||TWO_SIDED|95.0|-37.7|-4.6||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.6|-37.7|
91608689|NCT01624194|183110029|OTHER|||||||0.0275|||||||General Linear Model (GLM)|||||||0.0275
91608690|NCT01624194|183110030|OTHER||||||>|0.05||||||Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.|Fisher Exact|||||||>0.05
91608691|NCT01624194|183110031|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
91608692|NCT01624194|183110034|OTHER|||||||0.3395|||||||General Linear Model (GLM)|||||||0.3395
91608693|NCT01624194|183110042|OTHER|||||||0.9757|||||||General Linear Model (GLM)|||||||0.9757
91608694|NCT01624194|183110043|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
91608695|NCT01624194|183110044|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91608696|NCT01624194|183110045|OTHER||||||>|0.05||||||For all blood pressure analyses.|Mixed Models Analysis|||||||>0.05
91608697|NCT04322708|183110046|SUPERIORITY||Percent Difference from Placebo|81.6|||<|0.0001|TWO_SIDED|95.0|71.5|89.0|||Fisher Exact|||||89.0|71.5|<0.0001
91608698|NCT04322708|183110046|SUPERIORITY||Percent Difference from Placebo|77.0|||<|0.0001|TWO_SIDED|95.0|66.1|85.4|||Fisher Exact|||||85.4|66.1|<0.0001
91608699|NCT04322708|183110047|SUPERIORITY||LSM Difference from Placebo|2.7||||0.247|TWO_SIDED|95.0|-1.9|7.3|||ANCOVA|||||7.3|-1.9|0.2470
91608700|NCT04322708|183110047|SUPERIORITY||LSM Difference from Placebo|-2.8||||0.2372|TWO_SIDED|95.0|-7.3|1.8|||ANCOVA|||||1.8|-7.3|0.2372
91608701|NCT04322708|183110048|SUPERIORITY||LSM Difference from Placebo|-95.7|||<|0.0001|TWO_SIDED|95.0|-109.0|-82.4|||ANCOVA|||||-82.4|-109|<0.0001
91608702|NCT04322708|183110048|SUPERIORITY||LSM Difference from Placebo|-96.2|||<|0.0001|TWO_SIDED|95.0|-110.0|-82.5|||ANCOVA|||||-82.5|-110|<0.0001
91608703|NCT04322708|183110049|SUPERIORITY||Percent Difference from Placebo|83.8|||<|0.0001|TWO_SIDED|95.0|74.4|90.8|||Fisher Exact|||||90.8|74.4|<0.0001
91608704|NCT04322708|183110049|SUPERIORITY||Percent Difference from Placebo|80.3|||<|0.0001|TWO_SIDED|95.0|69.8|87.9|||Fisher Exact|||||87.9|69.8|<0.0001
91608705|NCT04322708|183110050|SUPERIORITY||Percent Difference from Placebo|77.3|||<|0.0001|TWO_SIDED|95.0|66.4|85.5|||Fisher Exact|||||85.5|66.4|<0.0001
91608706|NCT04322708|183110050|SUPERIORITY||Percent Difference from Placebo|72.7|||<|0.0001|TWO_SIDED|95.0|61.3|81.9|||Fisher Exact|||||81.9|61.3|<0.0001
91608707|NCT04322708|183110051|SUPERIORITY||Percent Difference from Placebo|36.5|||<|0.0001|TWO_SIDED|95.0|22.9|49.5|||Fisher Exact|||||49.5|22.9|<0.0001
91608708|NCT04322708|183110051|SUPERIORITY||Percent Difference from Placebo|49.5|||<|0.0001|TWO_SIDED|95.0|35.9|61.0|||Fisher Exact|||||61.0|35.9|<0.0001
91608709|NCT04322708|183110052|SUPERIORITY||Percent Difference from Placebo|-4.8||||0.5561|TWO_SIDED|95.0|-19.2|10.0|||Fisher Exact|||||10.0|-19.2|0.5561
91608710|NCT04322708|183110052|SUPERIORITY||Percent Difference from Placebo|4.9||||0.5554|TWO_SIDED|95.0|-9.9|19.6|||Fisher Exact|||||19.6|-9.9|0.5554
91608711|NCT04322708|183110053|SUPERIORITY||LSM Difference from Placebo|-0.6||||0.9506|TWO_SIDED|95.0|-18.1|17.0|||ANCOVA|||||17.0|-18.1|0.9506
91608712|NCT04322708|183110053|SUPERIORITY||LSM Difference from Placebo|-17.6||||0.0511|TWO_SIDED|95.0|-35.4|0.1|||ANCOVA|||||0.1|-35.4|0.0511
91608713|NCT04322708|183110054|SUPERIORITY||LSM Difference from Placebo|2.6||||0.2007|TWO_SIDED|95.0|-1.4|6.7|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||6.7|-1.4|0.2007
91608714|NCT04322708|183110054|SUPERIORITY||LSM Difference from Placebo|-2.7||||0.1889|TWO_SIDED|95.0|-6.8|1.3|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||1.3|-6.8|0.1889
91608715|NCT04322708|183110055|SUPERIORITY||LSM Difference from Placebo|-0.3||||0.498|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.4980
91608716|NCT04322708|183110055|SUPERIORITY||LSM Difference from Placebo|0.2||||0.639|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||||1.2|-0.7|0.6390
91788315|NCT02484859|183457022|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
91788316|NCT02564432|183457023|EQUIVALENCE|This is not a randomized clinical trial but is an observational study, each patient's thigh skin site served as the control.|Base mean abundance|0.03|||<|0.05|TWO_SIDED|||||The reported p-value was calculated.|Unweighted UniFrac (qualitative)|Both weighted and unweighted UniFrac were calculated; weighted UniFrac is calculated to be p = 0.398 while unweighted UniFrac was P\<0.03|Differential abundance of Staphylococcus aureus in the stoma calculated by Log2 fold change (y-axis) versus base mean abundance (x-axis)|Sample similarity was calculated using the statistical comparisons of community composition.||||<0.05
91608717|NCT03542682|183110128|SUPERIORITY||Mean Difference (Final Values)|-55.67|||||TWO_SIDED|95.0|-124.63|13.3|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||13.30|-124.63|
91608718|NCT03542682|183110130|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-1.1|3.02|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||3.02|-1.10|
91608719|NCT03542682|183110131|SUPERIORITY||Mean Difference (Final Values)|131.85|||||TWO_SIDED|95.0|-246.7|510.41|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||510.41|-246.70|
91608720|NCT01212445|183110132|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.192||||0.179|TWO_SIDED|95.0|0.096|0.325|||Fisher Exact|||The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.325|0.096|0.1790
91608721|NCT01212445|183110132|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.314||||1|TWO_SIDED|95.0|0.191|0.459|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.459|0.191|1.0000
91608722|NCT01212445|183110132|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.196||||0.2558|TWO_SIDED|95.0|0.098|0.331|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.331|0.098|0.2558
91608723|NCT01212445|183110132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.774|4.763|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments."||4.763|0.774|
91608724|NCT01212445|183110132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.024|||||TWO_SIDED|95.0|0.386|2.72|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||2.720|0.386|
91653087|NCT00094302|183198882|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.||||0.99
91653088|NCT00094302|183198883|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.39
91608725|NCT01212445|183110134|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.077||||0.235|TWO_SIDED|95.0|0.021|0.185|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.185|0.021|0.2350
91653089|NCT00094302|183198883|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.01
91653090|NCT00094302|183198884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.25|TWO_SIDED|95.0|0.85|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee."||1.04|0.85|0.25
91791056|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91653091|NCT00094302|183198885|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
91653092|NCT00094302|183198885|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
91653093|NCT00094302|183198886|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.53
91653094|NCT00094302|183198886|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
91653095|NCT00094302|183198887|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.11
91653096|NCT00094302|183198887|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
91653097|NCT00094302|183198888|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.59
91653098|NCT00094302|183198888|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.54
91710116|NCT00492232|183312609|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.42||||0.389||95.0|0.64|3.13||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||3.13|0.64|0.389
91788317|NCT02564432|183457023|OTHER|"In this study, dissimilarities between the stomal and healthy thigh skins were tested.~Observational study. Used only for visualizing trends in the data."|PERMANOVA|0.001|||<|0.005|TWO_SIDED|||||Each stomal community type was distinguished by both its diversity and taxonomic composition|Bray-Curtis dissimilarities|Nonmetric multidimensional scaling (NMDS) of Bray-Curtis dissimilarities|||Loess Regression was used to visualize temporal trends in the Shannnon Diversity and relative abundance of microbes (Staphylococcus, Streptococcus, Corynebacterium, and obligate anaerobes).|||<0.005
91653099|NCT00094302|183198889|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.98
91653100|NCT00094302|183198889|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.02
91653101|NCT02761980|183198907|SUPERIORITY||LSM difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.15|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||5.15|1.13|0.002
91653102|NCT02761980|183198907|SUPERIORITY||LSM difference|0.91||||0.21|TWO_SIDED|95.0|-0.52|2.33|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.33|-0.52|0.210
91653103|NCT02761980|183198907|SUPERIORITY||LSM difference|0.79||||0.28|TWO_SIDED|95.0|-0.64|2.21|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.21|-0.64|0.280
91653104|NCT02761980|183198907|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.23||||0.03|TWO_SIDED|95.0|0.22|4.25|||ANCOVA|||||4.25|0.22|0.030
91653105|NCT02761980|183198907|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.35||||0.023|TWO_SIDED|95.0|0.33|4.37|||ANCOVA|||||4.37|0.33|0.023
91653106|NCT02761980|183198907|SUPERIORITY||LSM difference|-0.12||||0.864|TWO_SIDED|95.0|-1.54|1.29|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||1.29|-1.54|0.864
91653107|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.9||||0.004|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|||WSTD 0-2 hours||1.51|0.29|0.004
91788318|NCT02415842|183457175|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.12|||||TWO_SIDED|95.0|0.73|1.72|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.72|0.73|
91608726|NCT01212445|183110134|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.157||||0.5256|TWO_SIDED|95.0|0.07|0.286|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.286|0.070|0.5256
91608727|NCT01212445|183110134|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.118||||0.7746|TWO_SIDED|95.0|0.044|0.239|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.239|0.044|0.7746
91608728|NCT01212445|183110134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.233|||||TWO_SIDED|95.0|0.628|7.94|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||7.940|0.628|
91608729|NCT01212445|183110134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.424|6.043|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||6.043|0.424|
91608730|NCT01212445|183110135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.752||||0.1876|TWO_SIDED|95.0|-3.834|19.338|||ANCOVA|||||19.338|-3.834|0.1876
91608731|NCT01212445|183110135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.706||||0.768|TWO_SIDED|95.0|-9.729|13.141|||ANCOVA|||||13.141|-9.729|0.7680
91608732|NCT01212445|183110135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.046||||0.2941|TWO_SIDED|95.0|-17.412|5.32|||ANCOVA|||||5.320|-17.412|0.2941
91653108|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.39||||0.078|TWO_SIDED|95.0|-0.04|0.82|||ANCOVA|||WSTD 0-2 hours||0.82|-0.04|0.078
91608733|NCT01212445|183110136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.302||||0.8109|TWO_SIDED|95.0|-12.059|9.454|||ANCOVA|||||9.454|-12.059|0.8109
91608734|NCT01212445|183110136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075||||0.6995|TWO_SIDED|95.0|-12.693|8.544|||ANCOVA|||||8.544|-12.693|0.6995
91653109|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.3||||0.172|TWO_SIDED|95.0|-0.13|0.74|||ANCOVA|||WSTD 0-2 hours||0.74|-0.13|0.172
91653110|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.098|TWO_SIDED|95.0|-0.1|1.13|||ANCOVA|||WSTD 0-2 hours||1.13|-0.10|0.098
91653111|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.6||||0.054|TWO_SIDED|95.0|-0.01|1.21|||ANCOVA|||WSTD 0-2 hours||1.21|-0.01|0.054
91653112|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.692|TWO_SIDED|95.0|-0.52|0.34|||ANCOVA|||WSTD 0-2 hours||0.34|-0.52|0.692
91653113|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.87|||<|0.001|TWO_SIDED|95.0|0.86|2.88|||ANCOVA|||WSTD 0-4 hours||2.88|0.86|< 0.001
91653114|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.61||||0.094|TWO_SIDED|95.0|-0.1|1.33|||ANCOVA|||WSTD 0-4 hours||1.33|-0.10|0.094
91653115|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.45||||0.217|TWO_SIDED|95.0|-0.27|1.17|||ANCOVA|||WSTD 0-4 hours||1.17|-0.27|0.217
91710117|NCT03078127|183312644|SUPERIORITY|||||||0.615||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for statistical significance was set to 0.05|ANOVA|||No comparable preliminary data exists on mucociliary clearance (MCC) in response to airway clearance therapy methods (ACTs) for a power calculation. However, prior studies of medication effect on MCC gave a baseline mean change of Ave270 clr of 27.7% (std dev of 15.1%). Thus, the investigators estimated a mean change of 20% for effective ACT with the same estimate for variability (Std Dev of 15.1%). Using a paired 2-tailed test to compare means, 7 subjects were estimated to be needed.||||0.615
91710118|NCT03078127|183312645|SUPERIORITY|||||||0.696||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for significance was \< 0.05.|ANOVA|||||||0.696
91710119|NCT03078127|183312647|SUPERIORITY|||||||0.001||||||The a priori threshold of statistical significance was p = 0.05|t-test, 2 sided|||The investigators compared FENO before and after ACT in a pooled manner (i.e., grouping each of the comparisons together), as the study was not powered for FENO comparisons within each ACT type.||||0.001
91710120|NCT03078127|183312647|OTHER|A linear regression was performed between change in FENO and Ave90Clr||||||0.692||||||The a priori threshold for statistical significance (i.e., slope different than zero) between MCC and FENO was 0.05|Regression, Linear|||if the difference between pre and post-ACT FENO was significant (defined as p\<0.05), it was investigated whether change in FENO correlated with MCC (as represented by Ave90Clr)||||0.692
91710121|NCT03078127|183312648|SUPERIORITY|||||||0.146||||||Non-parametric test used due to lack of data normality. The a prior threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.146
91608735|NCT01212445|183110136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772||||0.885|TWO_SIDED|95.0|-11.329|9.784|||ANCOVA|||||9.784|-11.329|0.8850
91608736|NCT01212445|183110137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.886||||0.0486|TWO_SIDED|95.0|0.078|25.695|||ANCOVA|||||25.695|0.078|0.0486
91608737|NCT01212445|183110137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.8465|TWO_SIDED|95.0|-11.471|13.962|||ANCOVA|||||13.962|-11.471|0.8465
91608738|NCT01212445|183110137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.641||||0.0744|TWO_SIDED|95.0|-24.449|1.167|||ANCOVA|||||1.167|-24.449|0.0744
91608739|NCT01212445|183110138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.4591|TWO_SIDED|95.0|-6.153|13.534|||ANCOVA|||||13.534|-6.153|0.4591
91608740|NCT01212445|183110138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.887||||0.5546|TWO_SIDED|95.0|-6.765|12.539|||ANCOVA|||||12.539|-6.765|0.5546
91608741|NCT01212445|183110138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803||||0.8685|TWO_SIDED|95.0|-10.397|8.79|||ANCOVA|||||8.790|-10.397|0.8685
91608742|NCT01212445|183110139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.1865|TWO_SIDED|95.0|-0.774|0.152|||ANCOVA|||||0.152|-0.774|0.1865
91608743|NCT01212445|183110139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.139||||0.553|TWO_SIDED|95.0|-0.602|0.323|||ANCOVA|||||0.323|-0.602|0.5530
91608744|NCT01212445|183110139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172||||0.467|TWO_SIDED|95.0|-0.293|0.637|||ANCOVA|||||0.637|-0.293|0.4670
91608745|NCT04090164|183110140|OTHER||Odds Ratio (OR)|2.406||||0.0027|TWO_SIDED|95.0|1.341|4.316|||Fisher Exact|||Fisher exact test was used for testing of association of Breast Cancer diagnosis with anti-HCV test status.||4.316|1.341|0.0027
91608746|NCT04090164|183110140|OTHER||Odds Ratio (OR)|7.032||||0.0034|TWO_SIDED|95.0|1.582|31.25|||Fisher Exact|||Fisher exact test was used to test the association of Breast Cancer diagnosis with anti-HCV test result in women younger than 45 years.||31.25|1.582|0.0034
91608747|NCT02625402|183110142|EQUIVALENCE|Knowledge scores within 10% points|Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|7.6|<|0.05|TWO_SIDED|95.0|-8.8|21.5|||t-test, 2 sided|||||21.5|-8.8|<0.05
91608748|NCT01200433|183110145|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.94||||0.011|TWO_SIDED|90.0|0.84|1.05|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.05|0.84|0.011
91608749|NCT01200433|183110146|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.99|||<|0.001|TWO_SIDED|90.0|0.96|1.02|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.02|0.96|< 0.001
91608750|NCT01200433|183110148|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|99.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
91608751|NCT01200433|183110149|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.0||||0.91|TWO_SIDED|99.0|0.86|1.18|||Wilcoxon (Mann-Whitney)|||||1.18|0.86|0.91
91608752|NCT01200433|183110151|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.9||||0.02|TWO_SIDED|99.0|-4.1|0.2|||Wilcoxon (Mann-Whitney)|||||0.2|-4.1|0.02
91608753|NCT01200433|183110152|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||>|0.99|TWO_SIDED|99.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|>0.99
91613836|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.717||||0.0069|TWO_SIDED|95.0|0.563|0.913|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.563|0.0069
91608754|NCT00770861|183110163|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors \& baseline value as a covariate.||H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.||||<0.0001
91788319|NCT02415842|183457175|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.23|||||TWO_SIDED|95.0|0.83|1.81|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.81|0.83|
91608755|NCT00770861|183110164|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
91608756|NCT03439345|183110211|SUPERIORITY|For the time-to-event analyses, survival analytic methods will be used to evaluate the time to the first event during the entire study period. Cox proportional hazards regression analyses, adjusted for baseline covariates used in minimised randomisation, will be used to estimate the hazard ratios, 95% confidence intervals and corresponding p-values, comparing all participants allocated active fenofibrate with all those allocated placebo.|Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.58|0.91|||Regression, Cox|Adjusted for baseline covariates used in minimised randomisation.||||0.91|0.58|0.006
91608757|NCT03439345|183110212|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.91|0.57|0.005
91608758|NCT03439345|183110213|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.58||||0.08|TWO_SIDED|95.0|0.31|1.06|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.31|0.08
91608759|NCT03439345|183110214|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74||||0.003|TWO_SIDED|95.0|0.61|0.9|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.90|0.61|0.003
91608760|NCT03439345|183110215|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.85|0.52|0.001
91653116|NCT02761980|183198908|SUPERIORITY||LSM difference|1.26||||0.015|TWO_SIDED|95.0|0.24|2.27||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|ANCOVA|||WSTD 0-4 hours||2.27|0.24|0.015
91653117|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.42||||0.006|TWO_SIDED|95.0|0.4|2.44|||ANCOVA|||WSTD 0-4 hours||2.44|0.40|0.006
91608761|NCT03439345|183110216|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.5||||0.008|TWO_SIDED|95.0|0.3|0.84|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.84|0.30|0.008
91608762|NCT03439345|183110217|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline visual acuity.|Mean Difference (Final Values)|0.0||||0.36|TWO_SIDED|95.0|-0.01|0.01|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.01|-0.01|0.36
91608763|NCT03439345|183110218|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline VFQ-25 composite score.|Mean Difference (Final Values)|0.0||||0.58|TWO_SIDED|95.0|-1.0|1.0|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||1|-1|0.58
91608764|NCT03439345|183110219|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Index Score.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.02|0.02|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.02|-0.02|0.93
91608765|NCT03439345|183110220|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Visual Analogue Score.|Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-2.0|1.0|||Regression, Cox|||The estimates were derived from a linear mixed model repeated measures||1|-2|0.43
91608766|NCT03439345|183110221|OTHER||Mean Difference (Final Values)|-254.0|||||TWO_SIDED|95.0|-1062.0|624.0||||||||624|-1062|
91608767|NCT03439345|183110222|OTHER||Incremental cost-effectiveness ratio|614.0|||||TWO_SIDED||||||||£614 cost per QALY gained based on probabilistic analysis|||||
91653118|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.16||||0.659|TWO_SIDED|95.0|-0.87|0.55|||ANCOVA|||WSTD 0-4 hours||0.55|-0.87|0.659
91653119|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.62|||<|0.001|TWO_SIDED|95.0|1.16|4.08|||ANCOVA|||WSTD 0-6 hours||4.08|1.16|< 0.001
91653120|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.79||||0.135|TWO_SIDED|95.0|-0.25|1.82|||ANCOVA|||WSTD 0-6 hours||1.82|-0.25|0.135
91653121|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.7||||0.186|TWO_SIDED|95.0|-0.34|1.74|||ANCOVA|||WSTD 0-6 hours||1.74|-0.34|0.186
91710122|NCT03078127|183312649|SUPERIORITY|||||||0.041||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.041
91653122|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.83||||0.014|TWO_SIDED|95.0|0.37|3.29|||ANCOVA|||WSTD 0-6 hours||3.29|0.37|0.014
91653123|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.92||||0.011|TWO_SIDED|95.0|0.45|3.39|||ANCOVA|||WSTD 0-6 hours||3.39|0.45|0.011
91653124|NCT02761980|183198908|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.865|TWO_SIDED|95.0|-1.12|0.94|||ANCOVA|||WSTD 0-6 hours||0.94|-1.12|0.865
91653125|NCT02761980|183198909|SUPERIORITY|||||||0.449||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.449
91653126|NCT02761980|183198909|SUPERIORITY|||||||0.142||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.142
91653127|NCT02761980|183198909|SUPERIORITY|||||||0.822||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.822
91653128|NCT02761980|183198909|SUPERIORITY|||||||0.671||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.671
91710123|NCT03078127|183312649|OTHER|A linear regression was performed between change in pre and post-ACT adenosine (purine) in EBC and Ave90Clr||||||0.047||||||The a priori threshold of statistical significance was p = 0.05|Regression, Linear|||If the difference between pre and post-ACT adenosine (purine) in EBC was significant (defined as p\<0.05), the correlation between change in adenosine concentration and MCC (as represented by Ave90Clr) was investigated.||||0.047
91653129|NCT02761980|183198909|SUPERIORITY|||||||0.514||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.514
91653130|NCT02761980|183198909|SUPERIORITY|||||||0.191||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.191
91653131|NCT02761980|183198910|SUPERIORITY|||||||0.997||||||P-value, hazard ratio (HR) and corresponding 95% CI were calculated based on the proportional hazards (PH) model with treatment term in the model.|hazard ratio|||||||0.997
91653132|NCT02761980|183198910|SUPERIORITY|||||||0.998||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.998
91653133|NCT02761980|183198910|SUPERIORITY|||||||0.997||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.997
91653134|NCT02761980|183198911|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.67||||0.101|TWO_SIDED|95.0|-0.13|1.48|||ANCOVA|||||1.48|-0.13|0.101
91653135|NCT02761980|183198911|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.16||||0.582|TWO_SIDED|95.0|-0.41|0.73|||ANCOVA|||||0.73|-0.41|0.582
91653136|NCT02761980|183198911|SUPERIORITY||LSM difference|0.15||||0.614|TWO_SIDED|95.0|-0.43|0.72|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||0.72|-0.43|0.614
91653137|NCT02761980|183198911|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.212|TWO_SIDED|95.0|-0.29|1.32|||ANCOVA|||||1.32|-0.29|0.212
91653138|NCT02761980|183198911|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.53||||0.202|TWO_SIDED|95.0|-0.28|1.34|||ANCOVA|||||1.34|-0.28|0.202
91653139|NCT02761980|183198911|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.01||||0.965|TWO_SIDED|95.0|-0.58|0.55|||ANCOVA|||||0.55|-0.58|0.965
91653140|NCT01082952|183198929|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||The p value is calculated for the results of ASM proliferation following incubation with eosinophils isolated from patients in each group. p\< 0.05 was considered significant.|ANOVA|Proliferation data was evaluated using two-way factorial ANOVA followed by Bonferroni post hoc test.||||||<0.05
91653141|NCT02337933|183198931|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91653142|NCT02337933|183198932|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91653143|NCT02337933|183198933|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91653144|NCT02337933|183198934|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
91710124|NCT03078127|183312650|SUPERIORITY|||||||0.07||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.070
91710125|NCT05052697|183312707|OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A1||2.20|0.34|
91653145|NCT02337933|183198935|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
91653146|NCT02337933|183198936|OTHER|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
91653147|NCT02337933|183198937|OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
91653148|NCT02337933|183198938|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91653149|NCT02337933|183198939|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
91653150|NCT02337933|183198940|OTHER|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||||||0.224
91653151|NCT02337933|183198941|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
91653152|NCT02337933|183198942|OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
91653153|NCT02337933|183198943|OTHER|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||||||0.999
91653154|NCT02743702|183198961|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91653155|NCT00755326|183198962|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91653156|NCT01111110|183199007|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|21.0|STANDARD_ERROR_OF_MEAN|6.7||0.026|TWO_SIDED|95.0|3.8|41.7|||t-test, 2 sided|two sample effect size must be halved to account for mean difference estimates twice the effect size|See 4 Puff result|(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.||41.7|3.8|0.026
91653157|NCT01111110|183199008|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|23.5|STANDARD_ERROR_OF_MEAN|6.8||0.018|TWO_SIDED|95.0|6.0|41.0||The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B|t-test, 2 sided|Must take half the mean difference to estimate effect size|No comments|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||41.0|6.0|0.018
91653158|NCT01111110|183199009|SUPERIORITY_OR_OTHER_LEGACY||Effect size=half the mean diff|24.7|STANDARD_ERROR_OF_MEAN|6.6||0.013|TWO_SIDED|95.0|7.7|41.7|||t-test, 2 sided||You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.|Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1||41.7|7.7|0.013
91653159|NCT00662025|183199015|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|30.2|||||TWO_SIDED|95.0|19.2|43.0||||||||43.0|19.2|
91653160|NCT00662025|183199016|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|27.0|||||TWO_SIDED|95.0|16.6|39.7||||||||39.7|16.6|
91653161|NCT00662025|183199017|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.8|||||TWO_SIDED|95.0|37.9|63.6||||||||63.6|37.9|
91653162|NCT00662025|183199018|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|52.4|||||TWO_SIDED|95.0|39.4|65.1||||||||65.1|39.4|
91653163|NCT01333033|183199036|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91653164|NCT01842958|183199082|NON_INFERIORITY|The test arm will be considered non-inferior to the control arm if the 95% upper confidence interval of the estimated difference between the test and control arms is less than -0.5mm.||||||0.02|||||||ANCOVA|||The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.||||0.02
91653165|NCT00818623|183199115|SUPERIORITY_OR_OTHER_LEGACY|||||||5.86e-05||95.0|||||Log Rank|||||||0.0000586
91653166|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Kruskal-Wallis|||||||0.0014
91653167|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|87.5||||||95.0|66.1|95.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||95.8|66.1|
91653168|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|66.7||||||95.0|33.7|86.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||86|33.7|
91653169|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|54.5||||||95.0|22.9|78.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78|22.9|
91653170|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|100.0||||||95.0|85.8|100.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||100|85.8|
91653171|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|75.0||||||95.0|52.6|87.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||87.9|52.6|
91653172|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|95.7||||||95.0|72.9|99.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||99.4|72.9|
91653173|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|62.5||||||95.0|40.3|78.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78.4|40.3|
91653174|NCT00818623|183199116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|88.9||||||95.0|69.4|96.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||96.3|69.4|
91653175|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||Kruskal-Wallis|||||||0.0031
91710126|NCT05052697|183312707|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|95.0|0.86|2.7|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A2||2.70|0.86|
91608768|NCT03439345|183110223|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.58|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.58|
91608769|NCT03439345|183110224|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.4|1.0||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.00|0.40|
91653176|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|45.8||||||95.0|25.6|64.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64|25.6|
91653177|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|38.1||||||95.0|12.1|64.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64.3|12.1|
91653178|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|32.7||||||95.0|8.3|60.6||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||60.6|8.3|
91653179|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|83.3||||||95.0|61.5|93.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||93.4|61.5|
91653180|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|49.4||||||95.0|28.3|67.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.4|28.3|
91653181|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|82.0||||||95.0|58.8|92.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||92.8|58.8|
91653182|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|50.0||||||95.0|29.1|67.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.8|29.1|
91608770|NCT03439345|183110225|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.97||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.97|0.52|
91608771|NCT03439345|183110226|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.55|1.07||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.07|0.55|
91653183|NCT00818623|183199117|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|70.4||||||95.0|49.4|83.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||83.9|49.4|
91653184|NCT00818623|183199118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||95.0|||||Log Rank|||||||0.0866
91653185|NCT00818623|183199119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Log Rank|||||||0.033
91653186|NCT00818623|183199120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0|||||Log Rank|||||||0.131
91653187|NCT01166568|183199124|SUPERIORITY||binomial distribution|0.75||||0.025|ONE_SIDED|97.5|0.75|||the p-value is adjusted for multiple comparisons|Fisher Exact|||"The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint."|||0.75|0.025
91653188|NCT00320593|183199167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|0.01|0.55|||ANCOVA|||The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.||0.55|0.01|
91653189|NCT00320593|183199167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|0.02|0.53|||ANCOVA|||An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.||0.53|0.02|
91653190|NCT00320593|183199170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.005|0.28|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.||0.28|-0.005|
91710127|NCT05052697|183312707|OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.4|2.28|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B1||2.28|0.40|
91608772|NCT03439345|183110227|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.21||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.21|0.51|
91710128|NCT05052697|183312707|OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.25|1.18|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B2||1.18|0.25|
91608773|NCT03439345|183110228|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.54|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.54|
91608774|NCT03439345|183110229|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.28|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.28|
91608775|NCT03439345|183110230|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.6|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.60|
91608776|NCT03439345|183110231|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.49|0.95||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.95|0.49|
91608777|NCT03439345|183110232|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.06||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.53|
91608778|NCT03439345|183110233|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.55|3.57||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||3.57|0.55|
91608779|NCT03439345|183110234|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.03||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.03|0.48|
91608780|NCT03439345|183110235|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.56|
91608781|NCT03439345|183110236|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline UACR.|Hazard Ratio (HR)|-12.4|||||TWO_SIDED|95.0|-25.8|3.5|||||Estimates are in %.|Linear mixed model repeated measures analyses were conducted to estimate the trial-averaged percentage difference in geometric mean UACR between the randomised treatment groups. UACR data at baseline was available for 312 participants allocated fenofibrate and 310 participants allocated placebo.||3.5|-25.8|
91608782|NCT03439345|183110237|SUPERIORITY|"Adjusted for baseline covariates used in minimised randomisation.~."|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.69|1.6||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.60|0.69|
91608783|NCT03439345|183110238|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.11|1.12||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.12|0.11|
91608784|NCT05405166|183110239|NON_INFERIORITY|Non-inferiority was concluded if lower limit of relative risk 95% confidence interval (CI) was greater or equal to 0.839.|Relative risk|1.008||||0.0006|TWO_SIDED|95.0|0.903|1.126|||Farrington-Manning||Two-sided 95% CI estimated using Farrington-Manning method.|||1.126|0.903|0.0006
91608785|NCT05405166|183110240|NON_INFERIORITY|Applied anti-log procedure to convert original scale. Non-inferiority was concluded if lower limit of ratio of geometric mean 90% CI was greater or equal to 0.80.|Ratio of geometric mean|1.532|||||TWO_SIDED|90.0|1.316|1.784||||||||1.784|1.316|
91608786|NCT05405166|183110241|NON_INFERIORITY|Non-inferiority was concluded if lower limit of relative risk 95% CI was greater or equal to 0.6312.|Relative risk|1.011|||<|0.0001|TWO_SIDED|95.0|0.841|1.215|||Farrington-Manning||Two-sided 95% CI estimated using Farrington-Manning method.|A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.||1.215|0.841|<0.0001
91608787|NCT05405166|183110242|NON_INFERIORITY|Applied anti-log procedure to convert original scale. Non-inferiority was concluded if lower limit of ratio of geometric mean 90% CI was greater or equal to 0.80.|Ratio of geometric mean|1.302|||||TWO_SIDED|90.0|1.158|1.465||||||A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.05.||1.465|1.158|
91710129|NCT05052697|183312708|OTHER||Difference in percentage of participants|26.2|||||TWO_SIDED|95.0|-4.5|53.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A1||53.5|-4.5|
91608788|NCT05405166|183110243|SUPERIORITY||Relative risk|0.061|||<|0.0001|TWO_SIDED|95.0|0.022|0.164|||Fisher Exact||Two-sided 95% CI estimated using Wald method.|A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.||0.164|0.022|<0.0001
91653191|NCT00320593|183199171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|0.02|0.45|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.||0.45|0.02|
91710130|NCT05052697|183312708|OTHER||Difference in percentage of participants|17.1|||||TWO_SIDED|95.0|-19.2|49.4|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A2||49.4|-19.2|
91710131|NCT05052697|183312708|OTHER||Difference in percentage of participants|-12.4|||||TWO_SIDED|95.0|-41.7|19.1|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B1||19.1|-41.7|
91608789|NCT05405166|183110244|SUPERIORITY||Odds Ratio (OR)|2.036||||0.0001|TWO_SIDED|95.0|1.425|2.908||Stratified on multiple myeloma (MM) isotype (immunoglobulin G \[IgG\] versus non-IgG), body weight (\<=65 kg, \>65 to \<=85 kg, and \>85 kg), and number of prior lines (1 to 2 versus \>=3) according to IRT.|Cochran-Mantel-Haenszel||Two-sided 95% CI estimated using the Wald method.|A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.||2.908|1.425|0.0001
91608790|NCT01843374|183110300|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.4081|TWO_SIDED|95.0|0.76|1.12||P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.|Log Rank|The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.|Tremelimumab represents the numerator and Placebo the denominator|H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo||1.12|0.76|0.4081
91608791|NCT01843374|183110301|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.011||||0.926|TWO_SIDED|95.0|0.793|1.289||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank||Tremelimumab is the numerator and Placebo the denominator|||1.289|0.793|0.926
91608792|NCT01843374|183110302|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.0325|TWO_SIDED|95.0|0.68|0.98||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank|Stratification factors were EORTC status and Line of therapy|Tremelimumab is the numerator and placebo, the denominator|||0.98|0.68|0.0325
91608793|NCT00955110|183110318|SUPERIORITY_OR_OTHER||Least Square Means Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-41.6|-16.0||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-16.0|-41.6|<0.001
91608794|NCT00955110|183110318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-50.5|||<|0.001|TWO_SIDED|95.0|-63.4|-37.5||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-37.5|-63.4|<0.001
91608795|NCT00955110|183110318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|5.5||||0.395|TWO_SIDED|95.0|-7.3|18.3||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||18.3|-7.3|0.395
91608796|NCT00955110|183110318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|38.0|||<|0.001|TWO_SIDED|95.0|25.2|50.8||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||50.8|25.2|<0.001
91608797|NCT00955110|183110318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|56.0|||<|0.001|TWO_SIDED|95.0|43.1|68.9||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||68.9|43.1|<0.001
91608798|NCT00955110|183110318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|66.8|||<|0.001|TWO_SIDED|95.0|53.9|79.7||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||79.7|53.9|<0.001
91608799|NCT02128490|183110319|SUPERIORITY_OR_OTHER||Difference in Proportions|35.9|||<|0.001|TWO_SIDED|95.0|20.8|51.0|||Fisher Exact|||||51.0|20.8|<0.001
91608800|NCT02128490|183110319|SUPERIORITY_OR_OTHER||Difference in Proportions|44.7|||<|0.001|TWO_SIDED|95.0|28.9|60.5|||Fisher Exact|||||60.5|28.9|<0.001
91608801|NCT02128490|183110319|SUPERIORITY_OR_OTHER||Difference in Proportions|22.4||||0.034|TWO_SIDED|95.0|3.7|41.0|||Fisher Exact|||||41.0|3.7|0.034
91608802|NCT02128490|183110319|SUPERIORITY_OR_OTHER||Difference in Proportions|4.2||||0.817|TWO_SIDED|95.0|-18.2|26.6|||Fisher Exact|||||26.6|-18.2|0.817
91608803|NCT02128490|183110320|SUPERIORITY_OR_OTHER||Difference in Proportions|12.6||||0.224|TWO_SIDED|95.0|-3.9|29.0|||Fisher Exact|||||29.0|-3.9|0.224
91608804|NCT02128490|183110320|SUPERIORITY_OR_OTHER||Difference in Proportions|31.6||||0.004|TWO_SIDED|95.0|13.1|50.1|||Fisher Exact|||||50.1|13.1|0.004
91608805|NCT02128490|183110320|SUPERIORITY_OR_OTHER||Difference in Proportions|-17.5||||0.139|TWO_SIDED|95.0|-38.1|3.2|||Fisher Exact|||||3.2|-38.1|0.139
91608806|NCT02128490|183110320|SUPERIORITY_OR_OTHER||Difference in Proportions|4.3||||0.815|TWO_SIDED|95.0|-17.9|26.4|||Fisher Exact|||||26.4|-17.9|0.815
91608807|NCT02128490|183110321|SUPERIORITY_OR_OTHER||Difference in Proportions|53.8|||<|0.001|TWO_SIDED|95.0|38.2|69.5|||Fisher Exact|||||69.5|38.2|<0.001
91653192|NCT01851590|183199180|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Proportions and 95% confidence intervals (CIs) were calculated for negative KOH staining, negative cultures, and a combination of these at 4- and 10-month time points. Cochran-Mantel-Haenszel and χ2-tests were used to analyse efficacy criteria.|Cochran-Mantel-Haenszel|||The sample size was estimated according to complete mycological cure at 10 months. Estimation was based on the design of a binary-outcome head-to-head superiority trial. Orally administered terbinafine treatment was considered the active control. Approximately 25 patients / arm were required to have 80% power (β=0.2) at a two-sided α=0.05 significance level to detect a decrease in primary outcome from 50% in the terbinafine arm to 15% in the amorolfine or resin lacquer treatment arms.||||<0.05
91608808|NCT02128490|183110321|SUPERIORITY_OR_OTHER||Difference in Proportions|55.3|||<|0.001|TWO_SIDED|95.0|39.5|71.1|||Fisher Exact|||||71.1|39.5|<0.001
91608809|NCT02128490|183110321|SUPERIORITY_OR_OTHER||Difference in Proportions|21.4||||0.069|TWO_SIDED|95.0|-0.3|43.1|||Fisher Exact|||||43.1|-0.3|0.069
91608810|NCT02128490|183110321|SUPERIORITY_OR_OTHER||Difference in Proportions|-4.2||||0.817|TWO_SIDED|95.0|-26.6|18.2|||Fisher Exact|||||18.2|-26.6|0.817
91788320|NCT02415842|183457175|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|0.88|||||TWO_SIDED|95.0|0.63|1.24|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.24|0.63|
91788321|NCT02415842|183457176|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 21 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.66|||||TWO_SIDED|95.0|1.12|2.47|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.47|1.12|
91608811|NCT02243176|183110322|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6236|TWO_SIDED|95.0|-0.22|0.13||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.13|-0.22|0.6236
91608812|NCT02243176|183110323|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.7809|TWO_SIDED|95.0|-0.21|0.15||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.15|-0.21|0.7809
91608813|NCT02243176|183110324|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.39|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||0.39|0.12|<0.0001
91608814|NCT02243176|183110325|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.5044|TWO_SIDED|95.0|0.74|1.15|||Cochran-Mantel-Haenszel|stratefied by baseline disease severity (HbA1c\<8%, \>=8%)||||1.15|0.74|0.5044
91608815|NCT02243176|183110326|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.0518|TWO_SIDED|95.0|0.98|1.67|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||1.67|0.98|0.0518
91608816|NCT02243176|183110327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.18||0.8915|TWO_SIDED|95.0|-0.33|0.38|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||0.38|-0.33|0.8915
91608817|NCT02243176|183110328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.249||0.2248|TWO_SIDED|95.0|-0.186|0.791|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||0.791|-0.186|0.2248
91608818|NCT02243176|183110329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|8.407||0.3739|TWO_SIDED|95.0|-9.039|24.005|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||24.005|-9.039|0.3739
91608819|NCT02243176|183110330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.26||0.0078|TWO_SIDED|95.0|0.18|1.19|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||1.19|0.18|0.0078
91608820|NCT01332435|183110336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91608821|NCT01332435|183110336|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
91608822|NCT01332435|183110337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91608823|NCT01332435|183110337|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Chi-squared|||||||0.0006
91608824|NCT01332435|183110338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91653193|NCT01851590|183199181|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
91653194|NCT01851590|183199182|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
91653195|NCT01851590|183199183|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
91608825|NCT01332435|183110338|SUPERIORITY_OR_OTHER|||||||0.0699||95.0|||||Chi-squared|||||||0.0699
91653196|NCT01851590|183199184|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Qualitative data are expressed as frequencies and percentages, and differences between parallel groups were compared with the χ2-test or Fisher's exact test, as appropriate.|Chi-squared|||||||<0.05
91608826|NCT01332435|183110339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
91608827|NCT01332435|183110339|SUPERIORITY_OR_OTHER|||||||0.8645||95.0|||||Regression, Linear|||||||0.8645
91608828|NCT01332435|183110340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
91653197|NCT00321711|183199187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||||95.0|0.153|6.95||||||||6.950|0.153|
91788322|NCT02415842|183457176|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|2.16|||||TWO_SIDED|95.0|1.54|3.03|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||3.03|1.54|
91788323|NCT02415842|183457176|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.95|||||TWO_SIDED|95.0|1.49|2.54|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.54|1.49|
91788324|NCT02415842|183457176|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 385 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.63|||||TWO_SIDED|95.0|1.32|2.01|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.01|1.32|
91788325|NCT02415842|183457177|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.39|||||TWO_SIDED|95.0|1.14|1.69|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.69|1.14|
91788326|NCT02415842|183457177|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.49|||||TWO_SIDED|95.0|1.28|1.73|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.73|1.28|
91788327|NCT02415842|183457177|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|1.0|1.44|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.44|1.00|
91788328|NCT02415842|183457178|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|10.79|||||TWO_SIDED|95.0|-16.5|36.83|||Asymptotic standardized 95% CI|||||36.83|-16.50|
91788329|NCT02415842|183457178|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|12.0|||||TWO_SIDED|95.0|-14.45|36.98|||Asymptotic standardized 95% CI|||||36.98|-14.45|
91788330|NCT02415842|183457178|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|-6.07|||||TWO_SIDED|95.0|-30.56|18.65|||Asymptotic standardized 95% CI|||||18.65|-30.56|
91608829|NCT01332435|183110340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
91608830|NCT03704051|183110342|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.634|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.634
91653198|NCT00321711|183199187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.333||||||95.0|0.028|3.926||||||||3.926|0.028|
91788331|NCT02415842|183457179|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|27.08|||||TWO_SIDED|95.0|5.96|47.01|||Asymptotic standardized 95% CI|||||47.01|5.96|
91788332|NCT02415842|183457179|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|36.65|||||TWO_SIDED|95.0|11.41|57.53|||Asymptotic standardized 95% CI|||||57.53|11.41|
91788333|NCT02415842|183457179|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|6.39|||||TWO_SIDED|95.0|-11.91|24.71|||Asymptotic standardized 95% CI|||||24.71|-11.91|
91788334|NCT02415842|183457179|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 365.|Difference in percentage of subjects|6.9|||||TWO_SIDED|95.0|-6.19|22.15|||Asymptotic standardized 95% CI|||||22.15|-6.19|
91788335|NCT02415842|183457180|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|3.33|||||TWO_SIDED|95.0|-13.06|20.24|||Asymptotic standardized 95% CI|||||20.24|-13.06|
91788336|NCT02415842|183457180|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|16.67|||||TWO_SIDED|95.0|0.35|34.76|||Asymptotic standardized 95% CI|||||34.76|0.35|
91788337|NCT02415842|183457180|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|0.24|||||TWO_SIDED|95.0|-13.76|15.0|||Asymptotic standardized 95% CI|||||15.00|-13.76|
91653199|NCT00321711|183199187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.118||||||95.0|0.007|1.882|||||Adjusted by the stratification factor|||1.882|0.007|
91653200|NCT00321711|183199188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.063|15.988|||||Romiplostim/placebo|||15.988|0.063|
91608831|NCT03704051|183110343|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.115|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.115
91608832|NCT02517515|183110375|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment (SVR12) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-naïve group, the sample size 180 treatment-naïve participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
91608833|NCT02517515|183110375|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
91608834|NCT02517515|183110376|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR24 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
91608835|NCT02517515|183110376|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-experienced participants in the double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with SVR24 must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
91608836|NCT04902885|183110395|SUPERIORITY|||||||0.0003|||||||non-parametric ANCOVA|||70 subjects (35 per group) provided approximately 95% power at the test level of α = 0.05 (2-sided) .Assuming a dropout rate of approximately 12%, the sample size for Part II was 80 subjects (40 per group)||||0.0003
91608837|NCT00917384|183110418|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.776||||0.0473||95.0|0.603|0.998|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.998|0.603|0.0473
91653201|NCT00321711|183199189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||||95.0|0.347|9.618|||||Romiplostim/placebo|||9.618|0.347|
91653202|NCT00321711|183199189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.445||||||95.0|0.037|5.325|||||Romiplostim/placebo|||5.325|0.037|
91653203|NCT00321711|183199189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.444||||||95.0|0.032|6.08|||||Romiplostim/placebo|||6.080|0.032|
91653204|NCT00321711|183199190|SUPERIORITY_OR_OTHER||Difference in incidence rate|-33.5||||||95.0|-69.0|2.0|||||Romiplostim - placebo|||2.0|-69.0|
91608838|NCT00917384|183110419|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.483|||<|0.0001|TWO_SIDED|95.0|0.376|0.62|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.620|0.376|<0.0001
91653205|NCT00321711|183199190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.315||||||95.0|0.029|3.412||||||||3.412|0.029|
91653206|NCT00321711|183199190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.211||||||95.0|0.021|2.082||||||||2.082|0.021|
91653207|NCT01211769|183199196|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
91653208|NCT01211769|183199196|SUPERIORITY_OR_OTHER||Variance (F)|0.71||||0.69||95.0|||||ANOVA|||GROUP COMPARISON||||0.69
91653209|NCT01211769|183199197|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
91653210|NCT01211769|183199197|SUPERIORITY_OR_OTHER||Variance (F)|0.73||||0.53||95.0|||||ANOVA|||GROUP COMPARISON||||0.53
91788338|NCT00791973|183457203|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon signed-rank test|||||||0.33
91788339|NCT00791973|183457204|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon signed-rank test|||||||0.14
91608839|NCT00917384|183110420|SUPERIORITY_OR_OTHER_LEGACY||Difference Between Arms|24.2|||<|0.0001|TWO_SIDED|95.0|14.9|33.6|||Normal Approximation|||||33.6|14.9|<0.0001
91653211|NCT01211769|183199198|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
91653212|NCT01211769|183199198|SUPERIORITY_OR_OTHER||Variance (F)|1.08||||0.37||95.0|||||ANOVA|||GROUP COMPARISON||||0.37
91653213|NCT01709383|183199200|SUPERIORITY_OR_OTHER|||||||0.57|||||||Mixed Models Analysis|||||||.57
91653214|NCT01709383|183199202|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||.64
91653215|NCT01688037|183199209|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.2966|TWO_SIDED|95.0|-2.3|0.7|||ANCOVA|||||0.7|-2.3|0.2966
91653216|NCT01688037|183199210|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.743|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.743
91653217|NCT01688037|183199211|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1151|TWO_SIDED|95.0|-0.7|0.1|||ANOVA|||||0.1|-0.7|0.1151
91653218|NCT01688037|183199211|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0277|TWO_SIDED|95.0|-0.8|0.0|||ANOVA|||||0.0|-0.8|0.0277
91653219|NCT03065283|183199216|EQUIVALENCE|p\< or = 0.05|Mean Difference (Final Values)|0.09||||0.05|TWO_SIDED|95.0|-0.38|0.57|||t-test, 2 sided|||A paired t-test was used for intragroup analysis, and an independent Student's t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.||0.57|-0.38|0.05
91653220|NCT05440097|183199234|OTHER||Difference in percentage|12.79|||<|0.0001|TWO_SIDED|95.0|9.079|13.431|||Mixed Models Analysis|The primary analysis used mixed effect logistic regression model, taking the timepoint as the fixed effect, hospital and patient as random effects.||||13.431|9.079|<.0001
91653221|NCT05440097|183199235|SUPERIORITY||Difference in percentage|30.5|||||TWO_SIDED|95.0|26.82|34.25|||Normal approximation|||||34.25|26.82|
91653222|NCT05440097|183199236|SUPERIORITY||Difference in percentage|2.2|||||TWO_SIDED|95.0|0.77|3.58|||Normal approximation||Change from baseline in proportion at week 12|||3.58|0.77|
91653223|NCT05440097|183199236|SUPERIORITY||Difference in percentage|2.1|||||TWO_SIDED|95.0|0.57|3.56|||Normal approximation||Change from baseline in proportion at week 24|||3.56|0.57|
91653224|NCT05440097|183199236|SUPERIORITY||Difference in percentage|12.2||||||95.0|9.25|15.13|||Normal approximation||Change from baseline in proportion at week 36|||15.13|9.25|
91653225|NCT05440097|183199236|SUPERIORITY||Difference in percentage|13.1||||||95.0|10.32|15.79|||Normal approximation||Change from baseline in proportion at week 48|||15.79|10.32|
91653226|NCT05440097|183199238|SUPERIORITY||Difference in percentage|13.0|||||TWO_SIDED|95.0|9.21|16.85|||Normal approximation||Change from baseline in the Proportion at week 12|||16.85|9.21|
91653227|NCT05440097|183199238|SUPERIORITY||Difference in percentage|4.4|||||TWO_SIDED|95.0|0.61|8.23|||Normal approximation||Change from baseline in the proportion at week 24|||8.23|0.61|
91653228|NCT05440097|183199238|SUPERIORITY||Difference in percentage|6.5|||||TWO_SIDED|95.0|2.68|10.36|||Normal approximation||Change from baseline in the proportion at week 36|||10.36|2.68|
91788340|NCT00797966|183457208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.6551|TWO_SIDED|95.0|-2.87|1.81|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.81|-2.87|0.6551
91788341|NCT00797966|183457208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.7037|TWO_SIDED|95.0|-2.3|1.55|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.55|-2.30|0.7037
91608840|NCT01458340|183110443|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.69||0.6026|ONE_SIDED|95.0||3.2||α=0.05 significance level.|Mixed Model for Repeated Measures (MMRM)|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.2||0.6026
91608841|NCT01458340|183110443|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.69||0.4844|ONE_SIDED|95.0||2.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||2.7||0.4844
91653229|NCT04828161|183199288|SUPERIORITY||Least square (LS) mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.86|-0.32|||ANCOVA|||||-0.32|-0.86|<0.001
91653230|NCT04828161|183199288|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.014|TWO_SIDED|95.0|-0.6|-0.07|||ANCOVA|||||-0.07|-0.60|0.014
91653231|NCT04828161|183199288|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|-0.68|-0.15|||ANCOVA|||||-0.15|-0.68|0.002
91710132|NCT05052697|183312708|OTHER||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-29.2|32.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B2||32.5|-29.2|
91608842|NCT01458340|183110444|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.17||0.5269|ONE_SIDED|95.0||3.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.7||0.5269
91788342|NCT00797966|183457208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.0303|TWO_SIDED|95.0|-4.08|-0.21|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||-0.21|-4.08|0.0303
91788343|NCT00797966|183457209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4166|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo|||0.18|-0.43|0.4166
91608843|NCT01458340|183110444|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.16||0.2092|ONE_SIDED|95.0||1.8||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||1.8||0.2092
91608844|NCT01021007|183110458|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.005
91608845|NCT01021007|183110459|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
91608846|NCT01021007|183110460|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
91608847|NCT03293030|183110471|SUPERIORITY|Note: Our statistical test was run to identify the number of significant genes. The result is a number and there is no calculation of any comparative statistic such as an odds ratio.|||||<|0.05||||||P-value was adjusted for false discovery rate|Wilcoxon (Mann-Whitney)|||Single cell RNA-sequencing was used to calculate the number of differentially expressed genes in cutaneous CD4+ T cells between week 0 and week 12 in dupilumab-treated subjects. The calculation was performed in the software package Seurat (RRID:SCR\_016341) using the FindMarkers function, which utilizes a non-parametric Wilcoxon rank-sum test. Genes were considered significantly differentially expressed if the adjusted p-value \< 0.05 and the absolute value of log2(Fold Change) \> 1.0.||||<0.05
91608848|NCT04899271|183110472|SUPERIORITY|||||||0.807|||||||Chi-squared|||||||0.807
91608849|NCT04899271|183110473|SUPERIORITY|||||||0.746|||||||Chi-squared|||Comparison at month 6||||0.746
91788344|NCT00797966|183457209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4193|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.15|-0.35|0.4193
91608850|NCT04899271|183110473|SUPERIORITY|||||||0.201|||||||Chi-squared|||Comparison at month 18||||0.201
91608851|NCT04899271|183110474|SUPERIORITY|||||||0.867|||||||Chi-squared|||Comparison at month 6||||0.867
91608852|NCT04899271|183110474|SUPERIORITY|||||||0.769|||||||Chi-squared|||Comparison at month 12||||0.769
91608853|NCT04899271|183110474|SUPERIORITY|||||||0.776|||||||Chi-squared|||Comparison at month 18||||0.776
91608854|NCT04899271|183110475|SUPERIORITY|||||||0.521||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.521
91608855|NCT04899271|183110475|SUPERIORITY|||||||0.959||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.959
91608856|NCT04899271|183110475|SUPERIORITY|||||||0.773||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 18 for change from baseline||||0.773
91608857|NCT04899271|183110476|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.||Comparison at month 6 for change from baseline||||0.691
91608858|NCT04899271|183110476|SUPERIORITY|||||||0.685||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.685
91608859|NCT04899271|183110476|SUPERIORITY|||||||0.64||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.640
91608860|NCT04899271|183110477|SUPERIORITY|||||||0.867||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||Comparison at month 6||||0.867
91608861|NCT04899271|183110477|SUPERIORITY|||||||0.769||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared and Fisher's Exact test separated with a /.||Comparison at month 12||||0.769
91608862|NCT04899271|183110477|SUPERIORITY|||||||0.577|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||Comparison at month 18||||0.577
91653232|NCT03093454|183199306|EQUIVALENCE|Linear mixed effects models were used to investigate HADS scores (total, anxiety, and depression), sleep scores, and pain scores. Variables for time point (preoperative/Post-op Day 1/final Post-op Day) \& arm were analyzed. Adjustment for multiple pairwise comparisons used the Scheffe method. Analyses were conducted based on the intent to treat principle. P-values\<0.05 were considered statistically significant. Each time point, the mean and corresponding 95% confidence interval has been plotted.|Odds Ratio (OR)|95.0|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0||||The p value is calculated and adjusted for multiple comparisons.|Fisher Exact|||Lavender group compared to control group||||0.05
91608863|NCT04899271|183110478|SUPERIORITY|The effect of treatment on the cumulative number of severe hypoglycemic events was evaluated by means of a Cox proportional hazards model. The Andersen-Gill intensity model with model-based variance was utilized.|Hazard Ratio (HR)|1.271||||0.554|TWO_SIDED|95.0|0.573|2.819|||Cox proportional hazards model|Analysis is based on Cox proportional hazards model.||||2.819|0.573|0.554
91608864|NCT04899271|183110480|SUPERIORITY|||||||0.32||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 6 for change from baseline||||0.320
91608865|NCT04899271|183110480|SUPERIORITY|||||||0.398||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 12 for change from baseline||||0.398
91608866|NCT04899271|183110480|SUPERIORITY|||||||1||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||1.000
91608867|NCT04899271|183110481|SUPERIORITY|||||||0.892||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.892
91608868|NCT04899271|183110481|SUPERIORITY|||||||0.412||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.412
91608869|NCT04899271|183110481|SUPERIORITY|||||||0.371||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.371
91608870|NCT04871815|183110520|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Body Aches||||0.200
91608871|NCT04871815|183110520|SUPERIORITY|||||||0.0326|||||||Wilcoxon (Mann-Whitney)|||Headaches||||0.0326
91608872|NCT04871815|183110520|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||Coughing/Sneezing||||0.0043
91608873|NCT04871815|183110520|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Trouble Breathing||||0.0003
91608874|NCT04871815|183110520|SUPERIORITY|||||||0.3714|||||||Wilcoxon (Mann-Whitney)|||Congestion||||0.3714
91608875|NCT04871815|183110520|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.300
91608876|NCT04871815|183110520|SUPERIORITY|||||||0.2286|||||||Wilcoxon (Mann-Whitney)|||Loss of Smell/Taste||||0.2286
91608877|NCT04871815|183110520|SUPERIORITY|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||Anxiety||||0.999
91608878|NCT04871815|183110521|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91608879|NCT04871815|183110522|SUPERIORITY|||||||0.1963|||||||ANOVA|||||||0.1963
91608880|NCT04871815|183110523|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91608881|NCT04871815|183110523|SUPERIORITY|||||||0.0008||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 1 treatment (day 7 of study).||||0.0008
91608882|NCT04871815|183110523|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 7 treatment (day 14 of study).||||<0.0001
91608883|NCT04871815|183110523|SUPERIORITY|||||||0.0114||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 7 baseline (day 7 of study) vs Day 1 treatment (day 7 of study).||||0.0114
91608884|NCT04871815|183110523|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day7 baseline (day 7 of study) vs Day 7 treatment (day 14 of study)||||<0.0001
91608885|NCT01733329|183110524|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
91608886|NCT01733329|183110525|SUPERIORITY_OR_OTHER|||||||0.026|||||||Fisher Exact|||||||0.026
91608887|NCT01733329|183110526|SUPERIORITY_OR_OTHER|||||||0.058|||||||Fisher Exact|||||||0.058
91608888|NCT01733329|183110527|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||||||0.007
91608889|NCT01015443|183110540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.032||||0.921|TWO_SIDED|95.0|0.552|1.931|||Adjusted log rank|||||1.931|0.552|0.921
91608890|NCT00095303|183110574|SUPERIORITY_OR_OTHER||slope of linear trajectory of drug use|0.05||||0.27|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.|Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.||.14|-.04|.27
91608891|NCT00095303|183110576|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.26|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors||0.08|-0.28|.26
91653233|NCT01884025|183199313|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|t-Value: 0.55||Change in total BADS score.||||0.59
91608892|NCT00095303|183110592|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.21|TWO_SIDED|95.0|0.82|1.09|||GEE|||Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants||1.09|.82|.21
91608893|NCT00095303|183110594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.006|TWO_SIDED|95.0|-0.71|-0.12|||GEE|||Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors||-.12|-.71|<.006
91608894|NCT00095303|183110595|SUPERIORITY_OR_OTHER||Slope|0.12||||0.015|TWO_SIDED|95.0|0.03|0.22|||Mixed Models Analysis|||Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.||.22|.03|.015
91608895|NCT00095303|183110599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.12|TWO_SIDED|95.0|-0.18|1.54|||GEE|||||1.54|-.18|.12
91608896|NCT00095303|183110600|SUPERIORITY_OR_OTHER||Slope|0.33||||0.12|TWO_SIDED|95.0|-0.09|0.76|||GEE||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.||.76|-.09|.12
91608897|NCT00095303|183110604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.23|TWO_SIDED|95.0|-0.09|0.37|||GEE|||||.37|-.09|.23
91608898|NCT00258154|183110626|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 10 mIU/mL greater than -10%|Percentage point difference|0.0|||<|0.001||95.0|-3.7|3.6|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||3.6|-3.7|<0.001
91608899|NCT00258154|183110628|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 0.15 μg/mL greater than -10%.|Percentage point difference|-3.7||||0.015||95.0|-9.3|1.3|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||1.3|-9.3|0.015
91653234|NCT01884025|183199313|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|t Value: 0.03||Change in Activation Subscale||||0.98
91653235|NCT01884025|183199313|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|"DF: 18~1 Value: -0.04"||Change in Avoidance/Rumination Subscale||||0.96
91653236|NCT01884025|183199313|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|t Value: 1.31||Change in Work/School Impairment Subscale||||0.21
91653237|NCT01884025|183199313|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|t Value: 0.99||Change in Social Impairment Subscale||||0.34
91653238|NCT01884025|183199314|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|t Value: 0.33||||||0.75
91653239|NCT01884025|183199315|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||Change in overall physical activity frequency were compared between the two groups.||||0.72
91653240|NCT01884025|183199315|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t Value: -0.39||Change in moderate physical activity frequency between the two groups.||||0.70
91653241|NCT01884025|183199316|SUPERIORITY|||||||0.45|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 0.77||Change in the physical health scale of the RAND 12 were compared.||||0.45
91608900|NCT03842137|183110656|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.008|TWO_SIDED|95.0|-0.91|-0.15|||Regression, Linear|Utilizing a regression model, baseline craving scores, group condition, and their interaction are regressed on 2-week craving scores.||||-.15|-.91|.008
91608901|NCT03842137|183110657|SUPERIORITY|An ancova model was conducted comparing differences between tDCS and sham on post-stimulation theta burst rate, while controlling for pre-stimulation theta burst rate||||||0.005|||||||ANCOVA|||||||.005
91608902|NCT05139030|183110658|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Difference (Final Values)|-65.8|STANDARD_ERROR_OF_MEAN|26.97||0.0074|TWO_SIDED|95.0|-118.7|-12.9|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||-12.9|-118.7|0.0074
91608903|NCT05139030|183110659|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Ratio|0.77||||0.0018|TWO_SIDED|95.0|0.64|0.92|||ANCOVA|Total opioid consumption was transformed to log scale. Main effect of treatment, covariates: pooled Investigator site (categorical); age (continuous)||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||0.92|0.64|0.0018
91608904|NCT05139030|183110660|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0127|TWO_SIDED|95.0|0.51|0.96|||Cox proportional hazards model|Cox proportional hazard model: treatment as main effect, pooled Investigator site as categorical, and age and height as continuous covariates||||0.96|0.51|0.0127
91653242|NCT01884025|183199316|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|t Value: 0.76||Change in the mental health scale of the RAND 12 were compared.||||0.45
91653243|NCT01884025|183199317|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||||||0.72
91653244|NCT01884025|183199318|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|t Value: 0.15||||||0.88
91608905|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.3674|TWO_SIDED|95.0|-0.6|0.4||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.4|-0.6|0.3674
91608906|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1016|TWO_SIDED|95.0|-0.9|0.2||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-0.9|0.1016
91608907|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0215|TWO_SIDED|95.0|-1.4|0.0||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.4|0.0215
91608908|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.0794|TWO_SIDED|95.0|-1.2|0.2||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-1.2|0.0794
91653245|NCT01884025|183199319|SUPERIORITY|||||||0.08|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 1.83||||||.08
91608909|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.3606|TWO_SIDED|95.0|-0.7|0.5||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.5|-0.7|0.3606
91653246|NCT01884025|183199320|SUPERIORITY|||||||0.16||||||Chi Squared 1.98|Chi-squared|||||||.16
91788345|NCT00797966|183457209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0064|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.10|-0.60|0.0064
91608910|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0184|TWO_SIDED|95.0|-1.1|0.0||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.1|0.0184
91608911|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0476|TWO_SIDED|95.0|-1.1|0.1||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0476
91653247|NCT01884025|183199321|SUPERIORITY|||||||0.85||||||t value: .19|t-test, 2 sided|||||||.85
91608912|NCT05139030|183110661|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0529|TWO_SIDED|95.0|-1.1|0.1||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0529
91608913|NCT00613626|183110676|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|22.718||0.1|ONE_SIDED|90.0|||||Log Rank|||A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.||||0.10
91608914|NCT00613626|183110676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9518|TWO_SIDED|||||P-Value (2-tailed) is calculated based on the unstratified log-rank test.|Log Rank|Degrees of freedom=1||||||0.9518
91608915|NCT00613626|183110678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|TWO_SIDED||||||Difference in Rates|P-value (two-tailed) is calculated based on an unadjusted, normal-distribution approximation for the difference in rates.||||||0.2533
91608916|NCT00613626|183110679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872|TWO_SIDED||||||Difference in Rates|||||||0.8720
91653248|NCT01884025|183199322|SUPERIORITY|||||||0.6||||||t value: .54|t-test, 2 sided|||||||.60
91653249|NCT01884025|183199323|SUPERIORITY|||||||0.26||||||t value: -1.17|t-test, 2 sided|||||||.26
91653250|NCT01884025|183199324|SUPERIORITY|||||||0.08||||||t value: 1.85|t-test, 2 sided|||||||.08
91788346|NCT00797966|183457210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.449|TWO_SIDED|95.0|-2.67|6.02|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||6.02|-2.67|0.4490
91788347|NCT00797966|183457210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.7412|TWO_SIDED|95.0|-3.02|4.24|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||4.24|-3.02|0.7412
91788348|NCT00797966|183457210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.407|TWO_SIDED|95.0|-2.1|5.17|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||5.17|-2.10|0.4070
91788349|NCT00797966|183457211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.4954|TWO_SIDED|95.0|-0.86|0.42|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.42|-0.86|0.4954
91788350|NCT00797966|183457211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4902|TWO_SIDED|95.0|-0.73|0.35|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.35|-0.73|0.4902
91788351|NCT00797966|183457211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0161|TWO_SIDED|95.0|-1.2|-0.12|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.12|-1.20|0.0161
91788352|NCT00797966|183457217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.5953|TWO_SIDED|95.0|-2.54|1.46|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.46|-2.54|0.5953
91788353|NCT00797966|183457217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.9479|TWO_SIDED|95.0|-1.66|1.55|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.55|-1.66|0.9479
91788354|NCT00797966|183457217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0919|TWO_SIDED|95.0|-2.95|0.22|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.22|-2.95|0.0919
91788355|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.3998||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.3998
91788356|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.8838||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.8838
91788357|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.4012||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.4012
91788358|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.6131||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.6131
91788359|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.5964||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.5964
91788360|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.254||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.2540
91788361|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.8524||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.8524
91608917|NCT00613626|183110680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4577|TWO_SIDED||||||Log Rank|||||||0.4577
91608918|NCT00613626|183110681|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.05|||||TWO_SIDED|95.0|||||||Survival analysis of VEGF variants using cox proportional hazard analysis in arm A and arm B.|Data was not collected for safety lead-in participants and these participants were not included in the analysis.||||
91608919|NCT00613626|183110681|SUPERIORITY_OR_OTHER_LEGACY||Logistic Regression Analysis|0.05|||||TWO_SIDED|95.0|||||||Objective Response Analysis of VEGF variants using Logistic Regression Analysis in arm A and arm B|||||
91608920|NCT01299025|183110682|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91608921|NCT00004980|183110686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|STANDARD_ERROR_OF_MEAN|0.514||0.005||95.0|-4.65|-0.86||a priori threshold for statistical significance was .05|t-test, 2 sided|degree of freedom = 48||||-.86|-4.65|.005
91608922|NCT00004980|183110687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.327||0.002||95.0|0.507|2.03||a priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 48||null hypothesis is that the groups are the same||2.03|.507|.002
91653251|NCT01700621|183199341|NON_INFERIORITY|A noninferiority margin of -10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.|Seroconversion proportion difference|1.1|||||TWO_SIDED|95.0|-6.9|9.0||||||||9.0|-6.9|
91653252|NCT03588390|183199358|OTHER||Slope|0.696|STANDARD_ERROR_OF_MEAN|0.0971|||TWO_SIDED|95.0|0.5006|0.8914|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8914|0.5006|
91710133|NCT03796676|183312727|SUPERIORITY||Estimate of difference|16.7||||0.0147|TWO_SIDED|95.0|3.5|29.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||29.9|3.5|0.0147
91788362|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.6969||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.6969
91608923|NCT00004980|183110688|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.949|STANDARD_ERROR_OF_MEAN|0.524||0.001||95.0|-1.45|-0.44||A priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 46||||-.44|-1.45|.001
91608924|NCT00004980|183110689|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||a priori threshold for statistical significance = .05|Chi-squared|||||||.01
91608925|NCT05480514|183110690|SUPERIORITY|A superiority margin of 0.90 was used. Superiority was concluded if the lower bound of the 95% central posterior credible interval was above 0.90.|Mean Posterior Proportion|0.9741|STANDARD_DEVIATION|0.01244|||TWO_SIDED|95.0|0.9445|0.9926|||Bayesian beta-binomial model|||||0.9926|0.9445|
91608926|NCT00457639|183110731|SUPERIORITY||Mean Difference (Net)|13.8||||0.42|TWO_SIDED|95.0|-19.7|61.1|||Mixed Models Analysis|||||61.1|-19.7|0.42
91608927|NCT00457639|183110732|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.45|TWO_SIDED|95.0|-17.7|50.8|||Mixed Models Analysis|||||50.8|-17.7|0.45
91608928|NCT00630032|183110774|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.175|TWO_SIDED|95.0|0.59|1.1|||Log Rank|||||1.10|0.59|0.175
91788363|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.3108||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.3108
91788364|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.8719||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.8719
91608929|NCT00630032|183110775|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1687|TWO_SIDED|95.0|0.53|1.11|||Log Rank|||||1.11|0.53|0.1687
91608930|NCT00630032|183110776|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.6502|TWO_SIDED|95.0|0.45|1.63|||Log Rank|||||1.63|0.45|0.6502
91608931|NCT00630032|183110777|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0665|TWO_SIDED|95.0|0.49|1.02|||Log Rank|||||1.02|0.49|0.0665
91608932|NCT00630032|183110778|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.148|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||||1.08|0.59|0.148
91608933|NCT00630032|183110779|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8968|TWO_SIDED|95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8968
91788365|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.6105||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.6105
91788366|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.0709||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.0709
91608934|NCT02332915|183110780|SUPERIORITY|||||||0.0128|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for treated items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.0128
91608935|NCT02332915|183110781|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for untreated (generalization) items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.942
91710134|NCT03796676|183312727|SUPERIORITY||Estimate of difference|20.6||||0.003|TWO_SIDED|95.0|7.3|33.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||33.9|7.3|0.0030
91788367|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.9574||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.9574
91788368|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.231||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.2310
91608936|NCT02332915|183110782|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scores||||<.001
91608937|NCT03232073|183110783|SUPERIORITY||Treatment Effect (Rate Ratio)|0.779||||||95.0|0.629|0.965||||||||0.965|0.629|
91608938|NCT01093612|183110841|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
91608939|NCT01093612|183110842|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
91608940|NCT03191786|183110843|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.025|TWO_SIDED|95.0|0.63|0.97|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||0.97|0.63|0.025
91608941|NCT03191786|183110844|SUPERIORITY||Difference in OS Rates|6.5|||||TWO_SIDED|95.0|-3.3|16.3||||||OS Rate at 6 Months||16.3|-3.3|
91608942|NCT03191786|183110844|SUPERIORITY||Difference in OS Rates|5.1|||||TWO_SIDED|95.0|-4.9|15.0||||||OS Rate at 12 Months||15.0|-4.9|
91608943|NCT03191786|183110844|SUPERIORITY||Difference in OS Rates|7.4|||||TWO_SIDED|95.0|-1.6|16.5||||||OS Rate at 18 Months||16.5|-1.6|
91608944|NCT03191786|183110844|SUPERIORITY||Difference in OS Rates|11.9|||||TWO_SIDED|95.0|4.4|19.5||||||OS Rate at 24 Months||19.5|4.4|
91608945|NCT03191786|183110846|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.182|TWO_SIDED|95.0|0.7|1.07|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||1.07|0.70|0.182
91608946|NCT03191786|183110851|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.01||||0.975||95.0|0.57|1.78|||Log Rank|||Time to deterioration for Dyspnoea (single item QLQ-C30)||1.78|0.57|0.975
91608947|NCT03191786|183110851|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.89||||0.62|TWO_SIDED|95.0|0.55|1.42|||Log Rank|||Time to deterioration for Fatigue (multi items QLQ-C30)||1.42|0.55|0.620
91608948|NCT03191786|183110852|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.16||||0.653|TWO_SIDED|95.0|0.6|2.26|||Log Rank|||Time to deterioration for Cough (single item QLQ-LC13)||2.26|0.60|0.653
91608949|NCT03191786|183110852|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.51||||0.036|TWO_SIDED|95.0|0.27|0.97|||Log Rank|||Time to deterioration for Chest pain (single item QLQ-LC13)||0.97|0.27|0.036
91710135|NCT03796676|183312728|SUPERIORITY||Estimate of difference|26.5||||0.0002|TWO_SIDED|95.0|13.1|39.8|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||39.8|13.1|0.0002
91710136|NCT03796676|183312728|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.3|42.5|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||42.5|16.3|<0.0001
91788369|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.0672||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.0672
91788370|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.8441||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.8441
91788371|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.6741||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.6741
91788372|NCT00797966|183457218|SUPERIORITY_OR_OTHER|||||||0.0183||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.0183
91608950|NCT03191786|183110852|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.7||||0.125|TWO_SIDED|95.0|0.45|1.11|||Log Rank|||Time to deterioration for Dyspnoea (multiple items QLQ-LC13)||1.11|0.45|0.125
91608951|NCT03191786|183110852|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.75||||0.362|TWO_SIDED|95.0|0.41|1.39|||Log Rank|||Time to deterioration for Arm and/or shoulder pain (single item QLQ-LC13)||1.39|0.41|0.362
91608952|NCT03191786|183110852|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.68||||0.041|TWO_SIDED|95.0|0.46|0.99|||Log Rank|||Time to Confirmed Deterioration for the Composite of the 3 following symptoms: cough, dyspnoea (multi-items QLQ-LC13) and chest pain||0.99|0.46|0.041
91608953|NCT03191786|183110853|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.84||||0.272|TWO_SIDED|95.0|0.61|1.15|||Log Rank|||SP263 TC\>=1%||1.15|0.61|0.272
91608954|NCT03191786|183110854|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.87||||0.366|TWO_SIDED|95.0|0.64|1.18|||Log Rank|||SP263 TC\>=1%||1.18|0.64|0.366
91608955|NCT05110300|183110863|SUPERIORITY|||||||0.0283||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0283
91608956|NCT05110300|183110864|SUPERIORITY|||||||0.3118||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3118
91608957|NCT05110300|183110865|SUPERIORITY|||||||0.213||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.213
91608958|NCT05110300|183110865|EQUIVALENCE|MDC of the inpatient stroke population for the BBS was used as the equivalence bounds. Equivalence bounds were set at +/- 6.9|||||<|0.001||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||||||<0.001
91608959|NCT05110300|183110865|SUPERIORITY|||||||0.32||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.320
91608960|NCT05110300|183110866|SUPERIORITY|||||||0.2612||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.2612
91608961|NCT05110300|183110867|SUPERIORITY|||||||0.541||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5410
91653253|NCT03588390|183199358|OTHER||Slope|0.9244|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|0.6764|1.1724|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1724|0.6764|
91710137|NCT03796676|183312729|SUPERIORITY||Estimate of difference|14.7||||0.0119||95.0|3.5|25.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo|||25.9|3.5|0.0119
91608962|NCT05110300|183110868|SUPERIORITY|||||||0.6282||||||The a priori threshold for statistical significance was p\<0.05.|Wilcoxon (Mann-Whitney)|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.6282
91608963|NCT05110300|183110868|SUPERIORITY|||||||0.5056||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.5056
91653254|NCT03588390|183199359|OTHER||Slope|0.6533|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.4556|0.851|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8510|0.4556|
91653255|NCT03588390|183199359|OTHER||Slope|0.8586|STANDARD_ERROR_OF_MEAN|0.1307|||TWO_SIDED|95.0|0.5929|1.1242|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1242|0.5929|
91653256|NCT00384033|183199360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.198|TWO_SIDED|95.0|-0.6|2.7||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.||2.70|-0.60|0.198
91653257|NCT00384033|183199360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.028|TWO_SIDED|95.0|0.2|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.20|0.028
91653258|NCT00384033|183199360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.047|TWO_SIDED|95.0|0.0|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.00|0.047
91653259|NCT00384033|183199361|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.||||0.110
91788373|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.49||||0.3007|TWO_SIDED|95.0|0.12|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.12|0.3007
91788374|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.94||||0.8812|TWO_SIDED|95.0|0.42|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||2.10|0.42|0.8812
91788375|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.32||||0.0553|TWO_SIDED|95.0|0.1|1.07||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.07|0.10|0.0553
91788376|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.78||||0.6051|TWO_SIDED|95.0|0.3|2.05||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.05|0.30|0.6051
91788377|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.92||||0.8264|TWO_SIDED|95.0|0.46|1.85||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.85|0.46|0.8264
91653260|NCT00384033|183199361|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.009
91788378|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.869|TWO_SIDED|95.0|0.54|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.10|0.54|0.8690
91788379|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.35||||0.3441|TWO_SIDED|95.0|0.74|2.44||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.44|0.74|0.3441
91788380|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.14||||0.6375|TWO_SIDED|95.0|0.67|1.94||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.94|0.67|0.6375
91788381|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.31||||0.3135|TWO_SIDED|95.0|0.78|2.21||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.21|0.78|0.3135
91788382|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.35||||0.0035|TWO_SIDED|95.0|1.32|4.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||4.18|1.32|0.0035
91788383|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.4358|TWO_SIDED|95.0|0.7|2.31||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||2.31|0.70|0.4358
91788384|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.02||||0.0063|TWO_SIDED|95.0|1.2|3.41||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.41|1.20|0.0063
91608964|NCT05110300|183110869|SUPERIORITY|||||||0.558||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5580
91788385|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.3968|TWO_SIDED|95.0|0.72|2.23||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.23|0.72|0.3968
91608965|NCT05110300|183110870|SUPERIORITY|||||||0.0897||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0897
91608966|NCT05110300|183110871|SUPERIORITY|||||||0.0549||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.0549
91608967|NCT05110300|183110871|SUPERIORITY|||||||0.05626||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.05626
91608968|NCT05110300|183110872|SUPERIORITY|||||||0.0706||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0706
91608969|NCT05110300|183110873|SUPERIORITY|||||||0.1629||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.1629
91608970|NCT05110300|183110874|SUPERIORITY|||||||0.4271||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.4271
91608971|NCT05110300|183110874|SUPERIORITY|||||||0.419||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.4190
91608972|NCT05110300|183110875|SUPERIORITY|||||||0.3444||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3444
91608973|NCT05110300|183110876|SUPERIORITY|||||||0.3581||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3581
91608974|NCT05110300|183110877|SUPERIORITY|||||||0.906||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.9060
91608975|NCT05110300|183110877|SUPERIORITY|||||||0.0848||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.0848
91788386|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.299|TWO_SIDED|95.0|0.81|2.0||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.00|0.81|0.2990
91788387|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.39||||0.1614|TWO_SIDED|95.0|0.86|2.25||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.25|0.86|0.1614
91608976|NCT01709799|183110896|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,90.577)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||< .001
91608977|NCT01709799|183110896|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05|Mixed Models Analysis|Degrees of freedom are (4,90.564)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.995
91608978|NCT01709799|183110897|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,97.137)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<.001
91608979|NCT01709799|183110897|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,97.108)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.254
91608980|NCT01709799|183110898|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,99.647)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
91608981|NCT01709799|183110898|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,99.601)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.781
91653261|NCT00384033|183199361|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.008
91653262|NCT00384033|183199362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.248|TWO_SIDED|95.0|-0.1|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.40|-0.10|0.248
91653263|NCT00384033|183199362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.011|TWO_SIDED|95.0|0.1|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.10|0.011
91653264|NCT00384033|183199362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.026|TWO_SIDED|95.0|0.0|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.00|0.026
91653265|NCT00384033|183199363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.149|TWO_SIDED|95.0|-0.6|4.0||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||4.00|-0.60|0.149
91653266|NCT00384033|183199363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.004|TWO_SIDED|95.0|1.1|5.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.60|1.10|0.004
91653267|NCT00384033|183199363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.005|TWO_SIDED|95.0|1.1|5.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.80|1.10|0.005
91788388|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.29||||0.3254|TWO_SIDED|95.0|0.79|2.12||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.12|0.79|0.3254
91653268|NCT00384033|183199364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.473|TWO_SIDED|95.0|-0.22|0.46||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.46|-0.22|0.473
91788389|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.02||||0.9463|TWO_SIDED|95.0|0.64|1.62||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.62|0.64|0.9463
91653269|NCT00384033|183199364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.119|TWO_SIDED|95.0|-0.07|0.61||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.61|-0.07|0.119
91710138|NCT03796676|183312729|SUPERIORITY||Estimate of difference|26.1|||<|0.0001|TWO_SIDED|95.0|13.9|38.3|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo|||38.3|13.9|<0.0001
91788390|NCT00797966|183457219|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.74||||0.008|TWO_SIDED|95.0|1.14|2.65||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.65|1.14|0.0080
91788391|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.59||||0.5791|TWO_SIDED|95.0|0.09|3.9||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||3.90|0.09|0.5791
91788392|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.43||||0.2653|TWO_SIDED|95.0|0.1|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.10|0.2653
91608982|NCT01709799|183110899|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,102.315)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
91608983|NCT01709799|183110899|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,102.216)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.026
91608984|NCT01709799|183110900|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,93.240)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
91608985|NCT01709799|183110900|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,93.167)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.313
91608986|NCT01709799|183110901|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,115.573)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||0.630
91608987|NCT01709799|183110901|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,115.593)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.498
91608988|NCT03167619|183110908|SUPERIORITY||MLE assuming exponential distribution|0.18||||0.0023|TWO_SIDED|95.0|0.11|0.27|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.27|0.11|0.0023
91608989|NCT03167619|183110909|SUPERIORITY||MLE assuming exponential distribution|0.11|||<|0.0001|TWO_SIDED|95.0|0.07|0.19|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.19|0.07|<0.0001
91608990|NCT01009463|183110931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.06|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.06|0.72|0.181
91608991|NCT01009463|183110931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.81||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.81|0.54|<0.001
91608992|NCT01009463|183110931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.109|TWO_SIDED|95.0|0.7|1.04|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.04|0.70|0.109
91608993|NCT01009463|183110932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.76|1.13|||Regression, Cox|||||1.13|0.76|0.430
91653270|NCT00384033|183199364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.71|TWO_SIDED|95.0|-0.27|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.40|-0.27|0.710
91608994|NCT01009463|183110932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.59|0.89||Nominal p-value|Regression, Cox|||||0.89|0.59|0.002
91608995|NCT01009463|183110932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.114|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|||||1.04|0.69|0.114
91608996|NCT01009463|183110933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.05|0.67|0.125
91608997|NCT01009463|183110933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.78|0.49|<0.001
91608998|NCT01009463|183110933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.064|TWO_SIDED|95.0|0.64|1.01|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||1.01|0.64|0.064
91608999|NCT01009463|183110934|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.011|TWO_SIDED|95.0|0.009|0.072||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.072|0.009|0.011
91609000|NCT01009463|183110934|SUPERIORITY_OR_OTHER||Least squares mean difference|0.058|||<|0.001|TWO_SIDED|95.0|0.027|0.09||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.090|0.027|<0.001
91609001|NCT01009463|183110934|SUPERIORITY_OR_OTHER||Least squares mean difference|0.064|||<|0.001|TWO_SIDED|95.0|0.033|0.096||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.096|0.033|<0.001
91609002|NCT00609128|183110959|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|ANOVA with preplanned comparisons was used to generate two tailed P values. Paired t tests were used to make appropriate post-ANOVA comparisons.||"tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume."||||<0.05
91609003|NCT00843180|183110964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.0||0.8|TWO_SIDED|95.0|-5.4|4.2||unadjusted|t-test, 2 sided||this was a feasibility pilot study CI is descriptor of dispersion|comparison between groups by t-test||4.2|-5.4|0.80
91609004|NCT00843180|183110965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|0.0||0.29|TWO_SIDED|95.0|-6.9|2.1||unadjusted|t-test, 2 sided||CI serves as dispersion measure|||2.1|-6.9|0.29
91609005|NCT00843180|183110966|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.8|STANDARD_DEVIATION|0.0||0.78|TWO_SIDED|95.0|-31.9|24.3|||t-test, 2 sided||95% CI is dispersion parameter|||24.3|-31.9|0.78
91609006|NCT00843180|183110967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_DEVIATION|0.0||0.7|TWO_SIDED|95.0|-9.5|13.2|||t-test, 2 sided|unadjusted|95%CI is dispersion measure|||13.2|-9.5|0.70
91609007|NCT03429075|183110978|EQUIVALENCE|ANCOVA||||||0.17|||||||ANCOVA|||||||0.17
91609008|NCT00002850|183110998|SUPERIORITY_OR_OTHER|||||||0.218|||||||Fisher Exact|Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.||"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.~Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level."||||0.218
91609009|NCT02234622|183111028|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.002|TWO_SIDED|95.0|-8.2|-1.8|||Mixed Models Analysis|||||-1.8|-8.2|0.002
91609010|NCT02234622|183111029|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.2||0.005|TWO_SIDED|95.0|-10.3|-1.8|||Mixed Models Analysis|||||-1.8|-10.3|0.005
91609011|NCT02234622|183111030|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|2.6||0.042|TWO_SIDED|95.0|-11.9|-1.6|||Mixed Models Analysis|||||-1.6|-11.9|0.042
91609012|NCT02234622|183111031|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.4||0.482|TWO_SIDED|95.0|-4.2|1.1|||Mixed Models Analysis|||||1.1|-4.2|0.482
91609013|NCT02234622|183111032|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.635|TWO_SIDED|95.0|-4.7|1.9|||Mixed Models Analysis|||||1.9|-4.7|0.635
91609014|NCT02234622|183111033|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.367|TWO_SIDED|95.0|-6.0|1.1|||Mixed Models Analysis|||||1.1|-6.0|0.367
91609015|NCT02234622|183111034|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.668|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||||1.0|-0.5|0.668
91609016|NCT05175170|183111140|OTHER||Mean Difference (Final Values)|-33.902|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
91609017|NCT05175170|183111140|OTHER||Mean Difference (Final Values)|-26.098|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
91609018|NCT05175170|183111141|OTHER||Mean Difference (Final Values)|-20.202||||0.002|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.002
91609019|NCT05175170|183111141|OTHER||Mean Difference (Final Values)|-8.081||||0.051|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.051
91609020|NCT01650805|183111145|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.074
91609021|NCT01650805|183111147|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||<0.001
91609022|NCT01650805|183111148|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.317
91609023|NCT03440112|183111257|SUPERIORITY||Chi-Squared|3.0039||||0.391|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.391
91609024|NCT03440112|183111258|SUPERIORITY||Chi-Squared|9.4836||||0.02351|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.02351
91609025|NCT02082184|183111259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8222|TWO_SIDED||||||ANCOVA|||||||0.8222
91609026|NCT02082184|183111260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7925|TWO_SIDED||||||ANCOVA|||||||0.7925
91609027|NCT02082184|183111261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<70 mg/dL||||<0.001
91609028|NCT02082184|183111261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.068||0.0014|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<55 mg/dL||||0.0014
91609029|NCT02082184|183111262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.065||0.0164|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||0.0164
91523522|NCT04270747|182922884|OTHER||Risk Difference (RD)|-3.4|||||TWO_SIDED|90.0|-9.8|3.1|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 10 letters of vision at Week 8.||3.1|-9.8|
91523523|NCT04270747|182922885|OTHER||Risk Difference (RD)|-5.3|||||TWO_SIDED|90.0|-13.6|2.5|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||2.5|-13.6|
91523524|NCT04270747|182922885|OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|90.0|-14.4|4.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||4.2|-14.4|
91523525|NCT04270747|182922886|OTHER||Difference between means|-0.048|||||TWO_SIDED|90.0|-0.734|0.638|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.638|-0.734|
91523526|NCT04270747|182922886|OTHER||Difference between means|0.431|||||TWO_SIDED|90.0|-0.367|1.229|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.229|-0.367|
91523527|NCT04270747|182922886|OTHER||Difference between means|0.197|||||TWO_SIDED|90.0|-0.625|1.019|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||1.019|-0.625|
91523528|NCT04270747|182922886|OTHER||Difference between means|0.156|||||TWO_SIDED|2.0|-0.561|0.872|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||0.872|-0.561|
91523529|NCT04270747|182922886|OTHER||Difference between means|0.105|||||TWO_SIDED|90.0|-0.682|0.891|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.891|-0.682|
91523530|NCT04270747|182922886|OTHER||Difference between means|0.245|||||TWO_SIDED|90.0|-0.667|1.158|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.158|-0.667|
91523531|NCT04270747|182922886|OTHER||Difference between means|-0.116|||||TWO_SIDED|90.0|-1.065|0.834|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||0.834|-1.065|
91523532|NCT04270747|182922886|OTHER||Difference between means|0.647|||||TWO_SIDED|90.0|-0.186|1.479|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||1.479|-0.186|
91523533|NCT04270747|182922887|OTHER||Difference between means|6.2|||||TWO_SIDED|90.0|-5.6|17.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||17.9|-5.6|
91523534|NCT04270747|182922887|OTHER||Difference between means|1.3|||||TWO_SIDED|90.0|-11.0|13.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||13.5|-11.0|
91523535|NCT04270747|182922887|OTHER||Difference between means|1.9|||||TWO_SIDED|90.0|-12.9|16.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||16.6|-12.9|
91523536|NCT04270747|182922887|OTHER||Difference between means|0.1|||||TWO_SIDED|90.0|-14.1|14.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||14.4|-14.1|
91609030|NCT02082184|183111262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.0017|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||0.0017
91609031|NCT02082184|183111263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.63||0.597|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5970
91609032|NCT02082184|183111263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8729|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>240 mg/dL||||0.8729
91609033|NCT02082184|183111266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.6075|TWO_SIDED||||||ANCOVA|||Perceived frequency of hyperglycaemia||||0.6075
91609034|NCT02082184|183111266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2295|TWO_SIDED||||||ANCOVA|||Perceived frequency of hypoglycaemia||||0.2295
91609035|NCT02082184|183111266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED||||||ANCOVA|||Total treatment satisfaction score||||<0.001
91710139|NCT03796676|183312729|SUPERIORITY||Estimate of difference|10.9||||0.0971|TWO_SIDED|95.0|-1.8|23.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo|||23.6|-1.8|0.0971
91609036|NCT01943539|183111274|SUPERIORITY||Effect Size|0.62||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
91609037|NCT01362322|183111278|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted radio|0.96|||||TWO_SIDED|95.0|0.85|1.09|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.||1.09|0.85|
91609038|NCT01362322|183111278|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.||1.1|0.86|
91609039|NCT01362322|183111279|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.82|1.04|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.||1.04|0.82|
91609040|NCT01362322|183111279|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.||1.03|0.83|
91609041|NCT01362322|183111279|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted ratio|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.||1.13|0.85|
91609042|NCT02413398|183111293|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|||Difference in adjusted mean change from baseline (MMRM model)||-0.15|-0.53|<0.001
91653271|NCT00384033|183199365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.215|TWO_SIDED|95.0|-0.3|1.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||1.50|-0.30|0.215
91710140|NCT03796676|183312729|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.0|42.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo|||42.9|16.0|<0.0001
91788393|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.39||||0.2259|TWO_SIDED|95.0|0.08|1.87||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.87|0.08|0.2259
91788394|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.83||||0.6986|TWO_SIDED|95.0|0.32|2.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.18|0.32|0.6986
91788395|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.61||||0.2339|TWO_SIDED|95.0|0.28|1.35||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.35|0.28|0.2339
91788396|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.07||||0.8615|TWO_SIDED|95.0|0.53|2.15||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.15|0.53|0.8615
91788397|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.06||||0.8807|TWO_SIDED|95.0|0.51|2.2||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.20|0.51|0.8807
91788398|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9035|TWO_SIDED|95.0|0.52|1.77||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.77|0.52|0.9035
91788399|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.19||||0.5898|TWO_SIDED|95.0|0.64|2.24|||Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.24|0.64|0.5898
91788400|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.82||||0.084|TWO_SIDED|95.0|0.93|3.58||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.58|0.93|0.0840
91788401|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9115|TWO_SIDED|95.0|0.49|1.88||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.88|0.49|0.9115
91788402|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.77||||0.0522|TWO_SIDED|95.0|0.98|3.17||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.17|0.98|0.0522
91788403|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.24||||0.4997|TWO_SIDED|95.0|0.65|2.34||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.34|0.65|0.4997
91788404|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.16||||0.5846|TWO_SIDED|95.0|0.69|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.93|0.69|0.5846
91788405|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.99||||0.9602|TWO_SIDED|95.0|0.55|1.76||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.76|0.55|0.9602
91788406|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.62||||0.1254|TWO_SIDED|95.0|0.87|3.02||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||3.02|0.87|0.1254
91788407|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.13||||0.667|TWO_SIDED|95.0|0.65|1.99||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.99|0.65|0.6670
91788408|NCT00797966|183457220|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.7||||0.0525|TWO_SIDED|95.0|0.98|2.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.93|0.98|0.0525
91788409|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.98||||0.9462|TWO_SIDED|95.0|0.52|1.84||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.84|0.52|0.9462
91788410|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.8||||0.4971|TWO_SIDED|95.0|0.43|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.49|0.43|0.4971
91788411|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.93||||0.8118|TWO_SIDED|95.0|0.53|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.63|0.53|0.8118
91788412|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.95||||0.8323|TWO_SIDED|95.0|0.59|1.53||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.53|0.59|0.8323
91788413|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.68||||0.093|TWO_SIDED|95.0|0.43|1.08||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.08|0.43|0.0930
91788414|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.88||||0.553|TWO_SIDED|95.0|0.59|1.32||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.32|0.59|0.5530
91788415|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.8007|TWO_SIDED|95.0|0.69|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.61|0.69|0.8007
91788416|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.03||||0.8945|TWO_SIDED|95.0|0.71|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.49|0.71|0.8945
91788417|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.17||||0.3837|TWO_SIDED|95.0|0.83|1.64||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.64|0.83|0.3837
91788418|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.7064|TWO_SIDED|95.0|0.72|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.63|0.72|0.7064
91609043|NCT02413398|183111294|SUPERIORITY||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.15|-0.69|||Mixed Models Analysis|||Difference in adjusted mean percent change from baseline (MMRM)||-0.69|-2.15|<0.001
91609044|NCT02413398|183111295|SUPERIORITY||Mean Difference (Final Values)|-16.59|STANDARD_ERROR_OF_MEAN|5.15||0.001|TWO_SIDED|95.0|-26.73|-6.45|||Mixed Models Analysis|||Difference in adjusted mean change from baseline versus placebo (MMRM)||-6.45|-26.73|0.001
91609045|NCT02413398|183111296|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.05|TWO_SIDED|95.0|-6.3|0.0|||Mixed Models Analysis|||Difference in adjusted mean change from baseline vs. placebo (MMRM)||0.0|-6.3|<0.050
91609046|NCT02158533|183111297|SUPERIORITY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.14||0.109|TWO_SIDED|95.0|-4.1|0.4||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.||0.4|-4.1|0.109
91609047|NCT02158533|183111297|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.17||0.975|TWO_SIDED|95.0|-2.3|2.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.||2.3|-2.3|0.975
91609048|NCT01475955|183111301|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Chi-squared|||Pearson chi-square||||0.0041
91613837|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.062|||<|0.0001|TWO_SIDED|95.0|1.056|1.067|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.067|1.056|<0.0001
91653272|NCT00384033|183199365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.005|TWO_SIDED|95.0|0.4|2.3||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.30|0.40|0.005
91788419|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.7469|TWO_SIDED|95.0|0.74|1.52||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.52|0.74|0.7469
91788420|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.34||||0.0832|TWO_SIDED|95.0|0.97|1.86||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.86|0.97|0.0832
91788421|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.6611|TWO_SIDED|95.0|0.74|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.61|0.74|0.6611
91788422|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.13||||0.4435|TWO_SIDED|95.0|0.83|1.56||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.56|0.83|0.4435
91788423|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0118|TWO_SIDED|95.0|1.09|1.98||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.98|1.09|0.0118
91788424|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.89||||0.5111|TWO_SIDED|95.0|0.63|1.26||Cochran-Mantel-Haenszel general association test controlling for study center.|Chi-squared, Corrected|||Week 14 values presented here.||1.26|0.63|0.5111
91788425|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.9||||0.4903|TWO_SIDED|95.0|0.66|1.22||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.22|0.66|0.4903
91788426|NCT00797966|183457221|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.28||||0.0662|TWO_SIDED|95.0|0.98|1.67||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.67|0.98|0.0662
91788427|NCT02478398|183457226|SUPERIORITY||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-3.45|-2.0|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-2.00|-3.45|< 0.001
91788428|NCT02478398|183457227|SUPERIORITY||Difference in LS Mean|-1.86|||<|0.001|TWO_SIDED|95.0|-2.46|-1.27|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-1.27|-2.46|< 0.001
91788429|NCT02478398|183457228|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-1.81|-0.99|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-0.99|-1.81|< 0.001
91788430|NCT02478398|183457229|SUPERIORITY||Mean Difference (Final Values)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.6|-1.08|||Zero-Inflated Log-Normal Model|Model included fixed effects of treatment, baseline asthma, age group, pollen season, and pollen region nested within pollen season||||-1.08|-2.60|< 0.001
91788431|NCT02478398|183457230|OTHER||Difference in % estimates|37.61|||<|0.001|TWO_SIDED|95.0|31.82|43.12|||Miettinen & Nurminen|||||43.12|31.82|< 0.001
91788432|NCT02478398|183457231|OTHER||Difference in % estimates|0.39|||=|0.32|TWO_SIDED|95.0|-0.57|1.53|||Miettinen & Nurminen|||||1.53|-0.57|= 0.320
91788433|NCT02478398|183457232|OTHER||Difference in % estimates|0.0|||=|0.996|TWO_SIDED|95.0|-0.92|0.92|||Miettinen & Nurminen|||||0.92|-0.92|= 0.996
91788434|NCT01475071|183457248|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority margin of -10%|Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|15.6||0.0345|ONE_SIDED|95.0|-6.8||||paired Student's t statistic|||The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.|||-6.8|0.0345
91788435|NCT01475071|183457249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_DEVIATION|2.7|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided Wilcoxon rank signed||superiority of Metvix adaylight and Metvix Lamp in term of pain||||<0.001
91788436|NCT01205581|183457255|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher Exact|||||||0.78
91788437|NCT01205581|183457258|SUPERIORITY_OR_OTHER|||||||0.48|||||||Fisher Exact|||||||0.48
91788438|NCT01205581|183457259|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||||||0.51
91788439|NCT01205581|183457260|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
91788440|NCT01205581|183457261|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
91788441|NCT01205581|183457262|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
91788442|NCT01512667|183457276|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|1.6|||||TWO_SIDED|90.0|1.15|2.23||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.||2.23|1.15|
91788443|NCT01512667|183457277|SUPERIORITY_OR_OTHER||GMR|1.46|||||TWO_SIDED|90.0|1.18|1.81||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.||1.81|1.18|
91788444|NCT02775240|183457283|OTHER||Ratio of geometric means|1.248|||||TWO_SIDED|90.0|1.13|1.378|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Digoxin||1.378|1.130|
91788445|NCT02775240|183457284|OTHER||Ratio of geometric means|0.944|||||TWO_SIDED|90.0|0.778|1.144|||Linear mixed effects model|||Comparison of Treatment B over Treatment A for Cmax of Dextromethorphan||1.144|0.778|
91788446|NCT02775240|183457285|OTHER||Ratio of geometric means|0.943|||||TWO_SIDED|90.0|0.883|1.007|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Dextrorphan||1.007|0.883|
91653273|NCT00384033|183199365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.024|TWO_SIDED|95.0|0.2|2.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.10|0.20|0.024
91653274|NCT00384033|183199366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.1|TWO_SIDED|95.0|-0.1|1.17||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.17|-0.10|0.100
91653275|NCT00384033|183199366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.014|TWO_SIDED|95.0|0.16|1.42||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.42|0.16|0.014
91653276|NCT00384033|183199366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.032|TWO_SIDED|95.0|0.06|1.38||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.38|0.06|0.032
91788447|NCT02775240|183457291|OTHER||Ratio of geometric means|1.206|||||TWO_SIDED|90.0|1.099|1.324|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Digoxin||1.324|1.099|
91788448|NCT02775240|183457293|OTHER||Ratio of geometric means|0.971|||||TWO_SIDED|90.0|0.943|0.999|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Dextrorphan||0.999|0.943|
91653277|NCT00384033|183199367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.445|TWO_SIDED|95.0|-0.2|0.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.50|-0.20|0.445
91653278|NCT00384033|183199367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.056|TWO_SIDED|95.0|0.0|0.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.70|-0.00|0.056
91653279|NCT00384033|183199367|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.90|0.10|0.006
91653280|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.124|TWO_SIDED|95.0|-0.9|7.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||7.90|-0.90|0.124
91653281|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.035|TWO_SIDED|95.0|0.3|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||9.10|0.30|0.035
91653282|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.1||||0.093|TWO_SIDED|95.0|-0.7|8.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||8.80|-0.70|0.093
91653283|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||0.177|TWO_SIDED|95.0|-1.4|7.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||7.70|-1.40|0.177
91653284|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.048|TWO_SIDED|95.0|0.1|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||9.10|0.10|0.048
91653285|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.088|TWO_SIDED|95.0|-0.5|8.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||8.10|-0.50|0.088
91653286|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.122|TWO_SIDED|95.0|-1.0|8.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||8.40|-1.00|0.122
91653287|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.015|TWO_SIDED|95.0|1.1|10.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||10.50|1.10|0.015
91653288|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.103|TWO_SIDED|95.0|-0.8|9.2||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||9.20|-0.80|0.103
91653289|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.384|TWO_SIDED|95.0|-1.7|4.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.50|-1.70|0.384
91788449|NCT02775240|183457294|OTHER||Ratio of geometric means|1.179|||||TWO_SIDED|90.0|1.08|1.287|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Digoxin||1.287|1.080|
91788450|NCT02775240|183457295|OTHER||Ratio of geometric means|0.882|||||TWO_SIDED|90.0|0.696|1.118|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast of Dextromethorphan||1.118|0.696|
91653290|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.221|TWO_SIDED|95.0|-1.2|5.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||5.10|-1.20|0.221
91653291|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.411|TWO_SIDED|95.0|-1.9|4.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.70|-1.90|0.411
91653292|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.412|TWO_SIDED|95.0|-2.8|6.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||6.70|-2.80|0.412
91653293|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.042|TWO_SIDED|95.0|0.2|9.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||9.60|0.20|0.042
91653294|NCT00384033|183199368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.155|TWO_SIDED|95.0|-1.2|7.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||7.80|-1.20|0.155
91653295|NCT02300025|183199380|SUPERIORITY_OR_OTHER||LS means ratio|92.2|||||TWO_SIDED|90.0|59.2|143.4|||||The 90% CI for differences in LS means between test and reference treatments obtained from mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model analysis of variance (ANOVA) to determine 90% confidence interval (CI) of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The least squares (LS) means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||143.4|59.2|
91653296|NCT02300025|183199380|SUPERIORITY_OR_OTHER||LS means ratio|84.9|||||TWO_SIDED|90.0|54.6|132.1|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||132.1|54.6|
91653297|NCT02300025|183199380|SUPERIORITY_OR_OTHER||LS means ratio|39.0|||||TWO_SIDED|90.0|25.1|60.7|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||60.7|25.1|
91653298|NCT02300025|183199382|SUPERIORITY_OR_OTHER||LS means ratio|98.4|||||TWO_SIDED|90.0|52.0|186.0|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||186.0|52.0|
91710141|NCT03796676|183312729|SUPERIORITY||Estimate of difference|22.8||||0.0035|TWO_SIDED|95.0|8.0|37.7|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||37.7|8.0|0.0035
91523537|NCT04270747|182922887|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-15.3|12.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||12.9|-15.3|
91653299|NCT02300025|183199382|SUPERIORITY_OR_OTHER||LS means ratio|102.2|||||TWO_SIDED|90.0|54.0|193.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||193.2|54.0|
91653300|NCT02300025|183199382|SUPERIORITY_OR_OTHER||LS means ratio|42.5|||||TWO_SIDED|90.0|22.5|80.5|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||80.5|22.5|
91653301|NCT02300025|183199383|SUPERIORITY_OR_OTHER||LS means ratio|97.6|||||TWO_SIDED|90.0|59.3|160.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||160.6|59.3|
91653302|NCT02300025|183199383|SUPERIORITY_OR_OTHER||LS means ratio|103.0|||||TWO_SIDED|90.0|62.6|169.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||169.6|62.6|
91653303|NCT02300025|183199383|SUPERIORITY_OR_OTHER||LS means ratio|68.5|||||TWO_SIDED|90.0|40.4|116.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||116.2|40.4|
91653304|NCT01227668|183199422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.097|TWO_SIDED|95.0|0.28|1.12|||Stratified log rank|||||1.12|0.28|0.097
91710142|NCT03796676|183312729|SUPERIORITY||Estimate of difference|25.6||||0.0013|TWO_SIDED|95.0|10.6|40.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||40.6|10.6|0.0013
91710143|NCT03796676|183312730|SUPERIORITY||Mean Difference (Net)|-0.5||||0.0664|TWO_SIDED|95.0|-1.1|0.0|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo|||0.0|-1.1|0.0664
91710144|NCT03796676|183312730|SUPERIORITY||Mean Difference (Net)|-0.7||||0.0142|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo|||-0.1|-1.3|0.0142
91653305|NCT01227668|183199423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.051|TWO_SIDED|95.0|-8.82|0.02||For secondary endpoints, hierarchical testing aimed to keep the overall experiment-wise type I error rate to \<=0.05. Difference in chg from BL was tested at 0.05 significance only if APR arm significantly differed vs placebo from primary analysis.|ANCOVA|||||0.02|-8.82|0.051
91653306|NCT01227668|183199424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.09|TWO_SIDED|95.0|-1.3|0.1||Treatment diff in chg from BL to endpnt in IS score was tested at 0.05 signif only if ARP arm signif differed vs pb from PA. Thus, if ARP arm signif differed vs pb in IS score, treatment diff in mean CGI-I score at endpnt was tested at 0.05 signfnce.|ANCOVA|||||0.1|-1.3|0.090
91653307|NCT04281485|183199427|SUPERIORITY||Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.78|=|0.9116|TWO_SIDED|95.0|-1.46|1.64|||Mixed Models Analysis||||The Mixed Model Repeated Measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|1.64|-1.46|=0.9116
91653308|NCT04281485|183199428|SUPERIORITY||Least Square Mean Difference|85.75|STANDARD_ERROR_OF_MEAN|17.17|=|0.0002|TWO_SIDED|95.0|49.15|122.35|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||122.35|49.15|=0.0002
91653309|NCT04281485|183199429|SUPERIORITY||Least Square Mean Difference|51.46|STANDARD_ERROR_OF_MEAN|9.49|<|0.0001|TWO_SIDED|95.0|31.43|71.49|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||71.49|31.43|<0.0001
91653310|NCT04281485|183199430|SUPERIORITY||Geometric Ratio of LS Means|0.64|||=|0.0002|TWO_SIDED|95.0|0.5|0.81|||Mixed Models Analysis||||MMRM approach for log transformed data including visits through Week 52 where serum CK concentration was assessed with fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction, and with additional fixed effects for natural log of baseline (continuous variable), screening age covariate (continuous variable), natural log of baseline by visit interaction, and screening age covariate by visit interaction with an unstructured variance-covariance matrix.|0.81|0.50|=0.0002
91710145|NCT02724410|183312769|OTHER|Chi Square test of independence||||||0.7188|||||||Chi-squared|||||||0.7188
91653311|NCT04281485|183199431|SUPERIORITY||Odds Ratio (OR)|1.73|||=|0.2784|TWO_SIDED|95.0|0.64|4.62|||Binomial regression||||The generalized mixed linear model assumed a binomial distribution with logit link \& contains fixed effects for treatment group (categorical variable) \& screening age (continuous variable).|4.62|0.64|=0.2784
91653312|NCT04281485|183199432|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.5437|TWO_SIDED|95.0|0.63|1.28|||Binomial Regression||||The generalized mixed linear model assumed a binomial distribution with a logit link and contained fixed effects for treatment group (categorical variable) and screening age (continuous variable).|1.28|0.63|=0.5437
91710146|NCT02724410|183312770|OTHER|Chi Square test of independence||||||0.5933|||||||Chi-squared|||||||.5933
91710147|NCT02724410|183312771|OTHER|Chi Square test of independence|||||>|0.99|||||||Chi-squared|||||||>.99
91710148|NCT02724410|183312772|OTHER|T-test for difference between groups|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<.0001
91710149|NCT02636439|183312816|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.21|TWO_SIDED|95.0|-25.0|112.0|||ANCOVA|adjusted for baseline value, age, and sex.||||112|-25|0.21
91710150|NCT02636439|183312817|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.8|-1.0|0.86
91710151|NCT02636439|183312818|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.77|TWO_SIDED|95.0|-2.8|3.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.8|-2.8|0.77
91710152|NCT02636439|183312819|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.85|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.2|-0.3|0.85
91653313|NCT04281485|183199433|SUPERIORITY||Least Square Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.082|=|0.3343|TWO_SIDED|95.0|-0.242|0.083|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.083|-0.242|=0.3343
91653314|NCT04281485|183199434|SUPERIORITY||Least Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.024|=|0.8826|TWO_SIDED|95.0|-0.052|0.045|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.045|-0.052|=0.8826
91653315|NCT04281485|183199435|SUPERIORITY||Least Square Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.63|=|0.219|TWO_SIDED|95.0|-1.22|5.24|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|5.24|-1.22|=0.2190
91653316|NCT04281485|183199436|SUPERIORITY||Least Square Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|2.96|=|0.7096||95.0|-4.79|7.0|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|7.00|-4.79|=0.7096
91653317|NCT00891878|183199457|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
91653318|NCT00891878|183199458|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
91653319|NCT01360450|183199463|OTHER||Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED|||||yes the P value was adjusted for multiple comparisons.|ANOVA|2 sided ANOVA|Mean difference between the two treatment arms|||||>0.05
91653320|NCT03211416|183199477|SUPERIORITY||Response Rate|0.296|||||TWO_SIDED|95.0|0.151|0.483||||||||0.483|0.151|
91523538|NCT04270747|182922887|OTHER||Difference between means|0.2|||||TWO_SIDED|90.0|-13.7|14.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||14.1|-13.7|
91523539|NCT04270747|182922887|OTHER||Difference between means|7.0|||||TWO_SIDED|90.0|-7.4|21.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||21.4|-7.4|
91523540|NCT04270747|182922887|OTHER||Difference between means|1.6|||||TWO_SIDED|2.0|-9.3|12.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||12.5|-9.3|
91523541|NCT04270747|182922887|OTHER||Difference between means|6.3|||||TWO_SIDED|90.0|-7.4|20.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||20.0|-7.4|
91523542|NCT04270747|182922887|OTHER||Difference between means|-5.1|||||TWO_SIDED|90.0|-19.3|9.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||9.1|-19.3|
91523543|NCT04270747|182922887|OTHER||Difference between means|-3.8|||||TWO_SIDED|90.0|-20.9|13.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||13.3|-20.9|
91523544|NCT04270747|182922887|OTHER||Difference between means|-6.0|||||TWO_SIDED|90.0|-22.6|10.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||10.6|-22.6|
91523545|NCT04270747|182922887|OTHER||Difference between means|-7.0|||||TWO_SIDED|90.0|-23.3|9.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||9.3|-23.3|
91523546|NCT04270747|182922887|OTHER||Difference between means|-6.5|||||TWO_SIDED|90.0|-22.8|9.8|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||9.8|-22.8|
91523547|NCT04270747|182922887|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-17.3|16.2|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||16.2|-17.3|
91523548|NCT04270747|182922887|OTHER||Difference between means|2.3|||||TWO_SIDED|90.0|-10.5|15.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||15.0|-10.5|
91523549|NCT02134925|182922924|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
91523550|NCT02134925|182922929|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
91523551|NCT02612064|182922996|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.1575|TWO_SIDED|95.0|-0.442|0.072|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as a factor and baseline Schiff sensitivity as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||0.072|-0.442|0.1575
91653321|NCT03211416|183199480|SUPERIORITY|||||||0.4||||||Significance level of 0.05.|Two-sided, one-sample t-test|||The null hypothesis is that the mean ratio of T effect cells (post / pre) is equal to 1 (no change).||||0.40
91710153|NCT02636439|183312820|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.053|TWO_SIDED|95.0|-0.1|12.9|||ANCOVA|Adjusted for baseline value, age, and sex.||||12.9|-0.1|0.053
91523552|NCT02036645|182923012|SUPERIORITY_OR_OTHER||Slope|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.04|0.82|
91710154|NCT02636439|183312821|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.043|TWO_SIDED|95.0|0.0|0.13|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.13|0.00|0.043
91653322|NCT00494806|183199486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7279|STANDARD_ERROR_OF_MEAN|0.15|<|0.05||95.0|0.3174|1.1383|||t-test, 2 sided|df = 64|Relative risk not calculated.|"No differences in time to first flatus between the rocking and non rocking groups is the null hypothesis.~Sample size calculations by setting the criterion for significance at .05, two-tailed test (an effect in either directions was accepted), and power at .80. A total sample of 54 participants was determined necessary to yield statistically significant results (27 in Group A and 27 in Group B)."||1.1383|0.3174|<0.05
91653323|NCT01533428|183199501|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6||||0.025|TWO_SIDED|95.0|-12.3|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level||-0.8|-12.3|0.025
91653324|NCT01533428|183199502|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.1||||0.018|TWO_SIDED|95.0|-12.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.2|-12.9|0.018
91653325|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1||||0.208|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.||2.3|-10.4|0.208
91653326|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.7||||0.036|TWO_SIDED|95.0|-13.1|-0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.||-0.4|-13.1|0.036
91653327|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.027|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.||-0.8|-13.5|0.027
91653328|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3||||0.024|TWO_SIDED|95.0|-13.6|-1.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.||-1.0|-13.6|0.024
91653329|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.051|TWO_SIDED|95.0|-12.6|0.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.||0.0|-12.6|0.051
91653330|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1||||0.012|TWO_SIDED|95.0|-14.4|-1.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.||-1.8|-14.4|0.012
91653331|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.026|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.||-0.8|-13.5|0.026
91653332|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.9||||0.032|TWO_SIDED|95.0|-13.2|-0.6|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.||-0.6|-13.2|0.032
91653333|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5||||0.02|TWO_SIDED|95.0|-13.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.||-1.2|-13.9|0.020
91653334|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4||||0.022|TWO_SIDED|95.0|-13.7|-1.1|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.||-1.1|-13.7|0.022
91653335|NCT01533428|183199503|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.005|TWO_SIDED|95.0|-15.3|-2.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.||-2.7|-15.3|0.005
91653336|NCT01533428|183199505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.108|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.2|0.9|0.108
91653337|NCT01533428|183199505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.05|TWO_SIDED|95.0|1.0|2.4|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.4|1.0|0.050
91710155|NCT02636439|183312822|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.07|TWO_SIDED|95.0|-10.0|0.0|||ANCOVA|Adjusted for baseline value, age, and sex.||||0|-10|0.07
91710156|NCT02636439|183312823|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.79|TWO_SIDED|95.0|-4.4|3.3|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.3|-4.4|0.79
91609049|NCT00315302|183111378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.24||0.21||95.0|-0.2|0.8|||ANCOVA||The difference was calculated as atropine plus plano group minus atropine group|"The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.~The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks."||0.8|-0.2|0.21
91609050|NCT00315302|183111379|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group"||||.03
91609051|NCT00315302|183111380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|3.1|||TWO_SIDED|95.0|3.2|5.8||||||95% confidence interval calculated within treatment group on the amount of change from baseline||5.8|3.2|
91609052|NCT00315302|183111380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.7|||TWO_SIDED|95.0|3.7|6.4||||||95% confidence interval calculated within treatment group on the amount of change from baseline||6.4|3.7|
91609053|NCT00315302|183111381|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group"||||0.39
91609054|NCT00315302|183111382|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||All patients without respect to cause of amblyopia.||||0.39
91609055|NCT00315302|183111383|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||Among anisometropic patients only||||0.90
91609056|NCT00315302|183111385|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||"Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;~Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups"||||0.003
91609057|NCT00091793|183111398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|6.2|7.8|||ANCOVA|||||7.8|6.2|<0.0001
91609058|NCT02424149|183111418|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||||||0.77
91609059|NCT02424149|183111419|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
91609060|NCT02424149|183111420|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91710157|NCT04679948|183312826|OTHER||Ratio of GLSMs [%]|112.06|||||TWO_SIDED|90.0|101.02|124.3|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) =16.2."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||124.30|101.02|
91788451|NCT02775240|183457296|OTHER||Ratio of geometric means|0.973|||||TWO_SIDED|90.0|0.949|0.998|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Dextrorphan||0.998|0.949|
91788452|NCT02775240|183457297|OTHER||Ratio of geometric means|0.905|||||TWO_SIDED|90.0|0.721|1.138|||Linear mixed effects model||Log-transformed AUClast ratio values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Dextromethorphan/Dextrorphan (Parent/Metabolite) AUClast ratio||1.138|0.721|
91788453|NCT00445588|183457339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4|TWO_SIDED|95.0|0.6|1.3||cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure|Regression, Cox|cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure||The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.||1.3|0.6|0.4
91788454|NCT03192358|183457357|SUPERIORITY||Cohen's d|1.18|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05.|ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study. The statistical test explores whether there were significant differences in tongue pressure between the two cohorts. The hypothesis was that individuals with ALS would display significantly lower maximum anterior isometric tongue pressures compared to the people with PD.||||< 0.001
91788455|NCT03192358|183457358|SUPERIORITY||Cohen's d|1.75|||<|0.001|TWO_SIDED||||||ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study rather than a trial. The hypothesis was that individuals with ALS would display significantly lower regular effort saliva swallow pressures than the individuals with PD.||||< 0.001
91788456|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.659|STANDARD_ERROR_OF_MEAN|0.0642|<|0.0001|TWO_SIDED|80.0|-61.95|-55.08|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-55.08|-61.95|<0.0001
91609061|NCT02424149|183111421|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
91609062|NCT02424149|183111422|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
91609063|NCT01238120|183111423|SUPERIORITY|||||||0.9168|||||||ANCOVA|||||||0.9168
91609064|NCT01238120|183111424|SUPERIORITY|||||||0.6536|||||||ANCOVA|||||||0.6536
91609065|NCT02498652|183111439|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|90.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||117|90.7|
91609066|NCT02498652|183111439|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.6|||||TWO_SIDED|90.0|78.1|110.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||110|78.1|
91609067|NCT02498652|183111439|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|85.7|120.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||120|85.7|
91609068|NCT02498652|183111439|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|88.9|||||TWO_SIDED|90.0|78.4|101.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||101|78.4|
91609069|NCT02498652|183111439|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.7|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale||||114|87.7|
91609070|NCT02498652|183111439|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|90.0|85.5|119.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||119|85.5|
91609071|NCT02498652|183111442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|94.3|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|94.3|
91609072|NCT02498652|183111442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.0|||||TWO_SIDED|90.0|90.4|106.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||106|90.4|
91609073|NCT02498652|183111442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|104.0|||||TWO_SIDED|90.0|94.5|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||114|94.5|
91609074|NCT02498652|183111442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.0|||||TWO_SIDED|90.0|86.7|97.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||97.7|86.7|
91609075|NCT02498652|183111442|NON_INFERIORITY|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.9|||||TWO_SIDED|90.0|91.0|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|91.0|
91609076|NCT02498652|183111442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%|Geometric Least Squares Mean Ratio (%)|97.5|||||TWO_SIDED|90.0|92.8|102.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||102|92.8|
91609077|NCT01078753|183111448|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.813||||0.009|TWO_SIDED|95.0|0.462|3.163||Desmopressin was considered to be superior to Placebo if the p-value for the comparison was \< 0.05 and the reduction from Baseline in number of wet nights was larger in the FE992026 group than in the Placebo group.|ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||3.163|0.462|0.009
91609078|NCT01078753|183111449|SUPERIORITY_OR_OTHER||Least Squares mean Difference|1.629||||0.018|TWO_SIDED|95.0|0.287|2.972|||ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||2.972|0.287|0.018
91609079|NCT01078753|183111450|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.183||||0.752|TWO_SIDED|95.0|-0.968|1.335|||ANCOVA|Factors in the analysis included Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||1.335|-0.968|0.752
91609080|NCT01184989|183111452|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|102.16|STANDARD_DEVIATION|22.8||||90.0|97.64|106.893|||Geometric Mean||Dispersion value is actually the intraindividual gCV.|Estimated local measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 136 quantifiable measurements.||106.893|97.640|
91609081|NCT01184989|183111453|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|92.37|STANDARD_DEVIATION|23.5||||90.0|90.079|94.719|||Geometric Mean||The Dispersion Value is actually the intraindividual gCV.|Estimated central measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 468 quantifiable measurements.||94.719|90.079|
91609082|NCT03826914|183111473|SUPERIORITY||Median Difference (Net)|-0.43||||0.042|TWO_SIDED|95.0|-0.846|-0.015||The threshold of significance was P=0.05|Anaylsis of Covariance||Placebo - Cardioflex|The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-0.015|-0.846|0.042
91609083|NCT03826914|183111474|SUPERIORITY||Mean Difference (Final Values)|-6.772||||0.04|TWO_SIDED|95.0|-11.2|-2.24||The threshold of significance was P=0.05|Anaylsis of Covariance|||The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-2.24|-11.2|0.04
91609084|NCT04334148|183111477|OTHER|||||||0.2|||||||Fisher Exact|||||||0.200
91609085|NCT04334148|183111478|OTHER|||||||1|||||||Regression, Linear|||||||1.0
91653338|NCT01533428|183199506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.403|TWO_SIDED|95.0|0.7|2.1|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.1|0.7|0.403
91653339|NCT01533428|183199506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.446|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.0|0.7|0.446
91653340|NCT01533428|183199507|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.072
91653341|NCT01533428|183199508|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.075
91653342|NCT01533428|183199509|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.169
91609086|NCT04334148|183111479|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
91523553|NCT02036645|182923012|SUPERIORITY_OR_OTHER||Slope|1.01|||||TWO_SIDED|95.0|0.71|1.3|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.30|0.71|
91609087|NCT05370157|183111480|SUPERIORITY||Mean Difference (Net)|4.25|STANDARD_ERROR_OF_MEAN|0.85||0.03|TWO_SIDED|95.0|0.76|7.74|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in knowledge from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||7.74|0.76|.03
91609088|NCT05370157|183111481|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3|TWO_SIDED|95.0|-0.4|0.2|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in skill use from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.20|-0.40|.30
91653343|NCT01533428|183199510|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.32|TWO_SIDED|95.0|-1.6|5.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.||5.0|-1.6|0.320
91653344|NCT01533428|183199510|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2||||0.473|TWO_SIDED|95.0|-2.1|4.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.||4.5|-2.1|0.473
91653345|NCT01533428|183199510|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.514|TWO_SIDED|95.0|-4.4|2.2|||ANCOVA|||The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.||2.2|-4.4|0.514
91653346|NCT01533428|183199511|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.719|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.7|-0.5|0.719
91609089|NCT05370157|183111485|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.45|TWO_SIDED|95.0|-1.25|0.79|||Regression, Linear|||Intent-to-treat analyses tested changes in psychological safety from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.79|-1.25|.45
91609090|NCT05370157|183111486|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.89|TWO_SIDED|95.0|-0.44|0.4|||Regression, Linear|||Intent-to-treat analyses tested changes in learning behavior from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.40|-0.44|.89
91609091|NCT05370157|183111487|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.36||0.85|TWO_SIDED|95.0|-1.51|1.36|||Regression, Linear|||Intent-to-treat analyses tested changes in team performance from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||1.36|-1.51|.85
91609092|NCT01508676|183111488|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||.04
91609093|NCT06129487|183111500|SUPERIORITY|||||||0.256|||||||ANCOVA|||||||0.256
91653347|NCT01533428|183199511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.3|-0.8|0.334
91609094|NCT03772327|183111501|SUPERIORITY||Mean Difference (Net)|0.333||||0.07|TWO_SIDED|95.0|-0.028|0.694|||t-test, 2 sided|A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.|The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.|The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.||0.694|-0.028|0.070
91609095|NCT03772327|183111502|EQUIVALENCE|Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p \> 0.05.|Difference in proportions|0.045||||0.89|TWO_SIDED|95.0|-0.179|0.27|||Chi-squared, Corrected|degrees of freedom = 1|This is the proportion of those completing a week 12 visit less those completing a week 0 visit.|The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.||0.270|-0.179|0.89
91609096|NCT03772327|183111503|SUPERIORITY||Median Difference (Net)|-0.07||||0.328|TWO_SIDED||||||Kruskal-Wallis|Log transformation of viral load|Difference of log viral load at Week 12 less the log viral load at baseline|Null hypothesis: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.||||0.328
91653348|NCT01533428|183199511|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.5|-0.7|0.726
91653349|NCT01533428|183199512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.841|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.5|-0.6|0.841
91653350|NCT01533428|183199512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.171|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.2|-0.9|0.171
91788457|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-68.026|STANDARD_ERROR_OF_MEAN|0.0665|<|0.0001|TWO_SIDED|80.0|-70.66|-65.16|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-65.16|-70.66|<0.0001
91609097|NCT03772327|183111504|SUPERIORITY||Odds Ratio (OR)|0.395||||0.294|TWO_SIDED|95.0|0.058|2.044|||Fisher Exact||Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA \< 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).|Null hypothesis: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA \< 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.||2.044|0.058|0.294
91609098|NCT03772327|183111506|SUPERIORITY||Difference in proportions|0.019||||1|TWO_SIDED|95.0|-0.237|0.276|||Chi-squared, Corrected|||Null hypothesis: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.||0.276|-0.237|1
91788458|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.152|STANDARD_ERROR_OF_MEAN|0.0643|<|0.0001|TWO_SIDED|80.0|-87.26|-84.95|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-84.95|-87.26|<0.0001
91609099|NCT04689828|183111507|SUPERIORITY||Hazard Ratio (HR)|0.41||||1e-08|TWO_SIDED|95.0|0.29|0.56|||Log Rank|Stratified||||0.56|0.29|0.00000001
91609100|NCT04689828|183111508|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2|TWO_SIDED|95.0|0.72|1.14|||stratified Cox PH model|||||1.14|0.72|0.20
91609101|NCT00195351|183111528|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.009||95.0|-13.1|5.1|||t-test, 2 sided|||||5.1|-13.1|0.009
91609102|NCT00195351|183111529|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.02||95.0|-14.5|7.8|||t-test, 2 sided|||||7.8|-14.5|0.020
91609103|NCT00195351|183111530|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9||||0.015||95.0|-13.9|8.1|||Method of Mehrotra and Railkar|||||8.1|-13.9|0.015
91609104|NCT03959189|183111532|SUPERIORITY||mixed effects model|-0.0796|STANDARD_ERROR_OF_MEAN|0.2768||0.7746|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following ERX-963 versus placebo. In the primary analysis of SSS, the cohort 1 and cohort 2 data were combined for ERX-963 and placebo treatments.||0.5|-0.6|0.7746
91609105|NCT03959189|183111532|SUPERIORITY||mixed effects model|-0.2608|STANDARD_ERROR_OF_MEAN|0.3589||0.47|TWO_SIDED|95.0|-1.0|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 1 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 1 mg ERX-963 treatment was compared to the effect of placebo treatment.||0.5|-1.0|0.4700
91609106|NCT03959189|183111532|SUPERIORITY||mixed effects model|0.1016|STANDARD_ERROR_OF_MEAN|0.4272||0.8127|TWO_SIDED|95.0|-0.8|1.0|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 2 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 2 mg ERX-963 treatment was compared to the effect of placebo treatment.||1.0|-0.8|0.8127
91609107|NCT01480180|183111562|OTHER||Poisson estimate|3.7|||<|0.001|TWO_SIDED|95.0|2.94|4.66||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.66|2.94|<0.001
91609108|NCT01480180|183111564|OTHER||Poisson estimate|3.27|||<|0.001|TWO_SIDED|95.0|2.59|4.11||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.11|2.59|<0.001
91609109|NCT01480180|183111566|OTHER||Poisson estimate|2.35|||<|0.001|TWO_SIDED|95.0|1.87|2.95||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||2.95|1.87|<0.001
91609110|NCT01480180|183111566|OTHER||Poisson estimate|4.39|||<|0.001|TWO_SIDED|95.0|3.09|6.24||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||6.24|3.09|<0.001
91609111|NCT02513446|183111639|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|176.1|||||TWO_SIDED|90.0|160.5|193.2|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||193.2|160.5|
91609112|NCT02513446|183111640|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|136.5|||||TWO_SIDED|90.0|109.9|169.4|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||169.4|109.9|
91788459|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.558|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-44.7|-36.1|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-36.10|-44.70|<0.0001
91788460|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.368|STANDARD_ERROR_OF_MEAN|0.0561|<|0.0001|TWO_SIDED|80.0|-54.78|-47.7|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-47.70|-54.78|<0.0001
91609113|NCT02513446|183111641|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|174.8|||||TWO_SIDED|90.0|159.1|192.0|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||192.0|159.1|
91609114|NCT04323488|183111653|OTHER|||||||0.925||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.925
91609115|NCT04323488|183111653|OTHER|||||||0.834||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.834
91609116|NCT04323488|183111653|OTHER|||||||0.18||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.180
91609117|NCT04323488|183111653|OTHER|||||||0.091||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.091
91609118|NCT04323488|183111654|OTHER|||||||0.524||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.524
91788461|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.583|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-62.4|-56.56|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.56|-62.40|<0.0001
91609119|NCT04323488|183111654|OTHER|||||||0.379||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.379
91609120|NCT04323488|183111654|OTHER|||||||0.01||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.010
91609121|NCT04323488|183111654|OTHER|||||||0.017||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.017
91609122|NCT04323488|183111655|OTHER|||||||0.6||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.60
91609123|NCT04323488|183111655|OTHER|||||||0.03||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.03
91609124|NCT04323488|183111655|OTHER|||||||0.6|||||||t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.60
91609125|NCT04323488|183111655|OTHER|||||||0.03||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.03
91788462|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.373|STANDARD_ERROR_OF_MEAN|0.1007|<|0.0001|TWO_SIDED|80.0|-45.06|-28.62|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-28.62|-45.06|<0.0001
91609126|NCT04323488|183111656|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||< 0.001
91609127|NCT04323488|183111656|OTHER|||||||0.29||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and post-intervention (within 2 weeks post-intervention)||||0.29
91609128|NCT04323488|183111656|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||< 0.001
91609129|NCT04323488|183111656|OTHER|||||||0.26||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Within-group analysis of change from baseline and 1 year follow up||||0.26
91609130|NCT05755438|183111670|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0003|TWO_SIDED|95.0|1.659|5.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||5.744|1.659|0.0003
91609131|NCT05755438|183111670|SUPERIORITY||Response Rate Difference|23.9|STANDARD_DEVIATION|6.372|||TWO_SIDED|95.0|11.42|36.39||||||||36.39|11.42|
91609132|NCT05755438|183111671|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0034|TWO_SIDED|95.0|1.4|6.033|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||6.033|1.400|0.0034
91609133|NCT05755438|183111671|SUPERIORITY||Response Rate Difference|16.77|STANDARD_ERROR_OF_MEAN|5.587|||TWO_SIDED|95.0|5.82|27.72||||||||27.72|5.82|
91788463|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.018|STANDARD_ERROR_OF_MEAN|0.1001|<|0.0001|TWO_SIDED|80.0|-51.72|-37.38|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-37.38|-51.72|<0.0001
91609134|NCT05755438|183111672|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0164|TWO_SIDED|95.0|1.206|16.485|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||16.485|1.206|0.0164
91609135|NCT05755438|183111672|SUPERIORITY||Response Rate Difference|8.75|STANDARD_ERROR_OF_MEAN|3.591|||TWO_SIDED|95.0|1.71|15.79||||||||15.79|1.71|
91609136|NCT05755438|183111673|SUPERIORITY||Odds Ratio (OR)|4.67||||0.0048|TWO_SIDED|95.0|1.486|14.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||14.647|1.486|0.0048
91609137|NCT05755438|183111673|SUPERIORITY||Response Rate Difference|11.66|STANDARD_ERROR_OF_MEAN|4.06|||TWO_SIDED|95.0|3.71|19.62||||||||19.62|3.71|
91609138|NCT05755438|183111674|SUPERIORITY||Odds Ratio (OR)|3.5||||0.0064|TWO_SIDED|95.0|1.422|8.608|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||8.608|1.422|0.0064
91609139|NCT05755438|183111674|SUPERIORITY||Response Rate Difference|14.35|STANDARD_ERROR_OF_MEAN|5.008|||TWO_SIDED|95.0|4.54|24.17||||||||24.17|4.54|
91609140|NCT05755438|183111675|SUPERIORITY||Least squares Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.28||0.0005|TWO_SIDED|95.0|-1.54|-0.44|||Mixed Model for Repeated Measures (MMRM)|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||-0.44|-1.54|0.0005
91609141|NCT05755438|183111675|SUPERIORITY||Least Squares Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.352|<|0.0001|TWO_SIDED|95.0|-2.11|-0.73|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||-0.73|-2.11|<0.0001
91609142|NCT05755438|183111675|SUPERIORITY||Least Squares Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|0.378|<|0.0001|TWO_SIDED|95.0|-2.43|-0.94|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||-0.94|-2.43|<0.0001
91609143|NCT05755438|183111675|SUPERIORITY||Least Squares Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.386|<|0.0001|TWO_SIDED|95.0|-2.43|-0.91|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||-0.91|-2.43|<0.0001
91609144|NCT05755438|183111678|SUPERIORITY||Hazard Ratio (HR)|1.925|||<|0.0001|TWO_SIDED|95.0|1.406|2.636|||Log Rank|Log-rank test stratified by randomization stratification factors between treatment and vehicle.|Cox regression model stratified by stratification factors (Baseline IGA 2/3, Region North America/ Outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.636|1.406|<0.0001
91609145|NCT05755438|183111679|SUPERIORITY||Hazard Ratio (HR)|2.111||||0.0002|TWO_SIDED|95.0|1.419|3.139|||Log Rank|Log-rank test stratified by randomization stratification factors between treatment and vehicle.|Cox regression model stratified by stratification factors (Baseline IGA 2/3, Region North America/ Outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||3.139|1.419|0.0002
91609146|NCT05755438|183111682|SUPERIORITY||Least Squares Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.264||0.0111|TWO_SIDED|95.0|-1.2|-0.16|||Mixed Model for Repeated Measures|||Week 2||-0.16|-1.20|0.0111
91609147|NCT05755438|183111682|SUPERIORITY||Least Squares Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.342||0.001|TWO_SIDED|95.0|-1.82|-0.47|||Mixed Model for Repeated Measures|||Week 4||-0.47|-1.82|0.0010
91609148|NCT05755438|183111682|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.372||0.0034|TWO_SIDED|95.0|-1.84|-0.37|||Mixed Model for Repeated Measures|||Week 8||-0.37|-1.84|0.0034
91609149|NCT05755438|183111682|SUPERIORITY||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.387||0.0038|TWO_SIDED|95.0|-1.9|-0.37|||Mixed Model for Repeated Measures|||Week 12||-0.37|-1.90|0.0038
91609150|NCT05755438|183111688|SUPERIORITY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.826||0.8028|TWO_SIDED|95.0|-1.84|1.42|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||1.42|-1.84|0.8028
91523554|NCT02036645|182923013|SUPERIORITY_OR_OTHER||Slope|0.9|||||TWO_SIDED|95.0|0.81|0.98|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||0.98|0.81|
91609151|NCT05755438|183111688|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.928||0.7151|TWO_SIDED|95.0|-2.17|1.49|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||1.49|-2.17|0.7151
91609152|NCT05755438|183111688|SUPERIORITY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.947||0.2569|TWO_SIDED|95.0|-2.95|0.79|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||0.79|-2.95|0.2569
91609153|NCT05755438|183111688|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.971||0.1555|TWO_SIDED|95.0|-3.3|0.53|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||0.53|-3.30|0.1555
91609154|NCT05755438|183111690|SUPERIORITY||Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|2.722||0.0736|TWO_SIDED|95.0|-0.47|10.27|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||10.27|-0.47|0.0736
91788464|NCT02509117|183457433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.797|STANDARD_ERROR_OF_MEAN|0.1014|<|0.0001|TWO_SIDED|80.0|-66.51|-56.42|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.42|-66.51|<0.0001
91788465|NCT03467685|183457482|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91788466|NCT01227824|183457500|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was \> -10%.|Difference in percentage|2.5|||||TWO_SIDED|95.0|-2.2|7.1|||||Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: baseline HIV-1 RNA and background dual NRTI.|||7.1|-2.2|
91609155|NCT05755438|183111690|SUPERIORITY||Least Squares Mean Difference|3.31|STANDARD_ERROR_OF_MEAN|2.729||0.2265|TWO_SIDED|95.0|-2.07|8.69|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||8.69|-2.07|0.2265
91609156|NCT05755438|183111690|SUPERIORITY||Least Squares Mean Difference|7.31|STANDARD_ERROR_OF_MEAN|3.061||0.018|TWO_SIDED|95.0|1.27|13.35|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||13.35|1.27|0.0180
91609157|NCT05755438|183111690|SUPERIORITY||Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.119||0.06|TWO_SIDED|95.0|-0.25|12.06|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||12.06|-0.25|0.0600
91609158|NCT01476787|183111750|SUPERIORITY|||||||0.128|||||||Cochran-Mantel-Haenszel|||||||0.128
91609159|NCT01476787|183111751|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.406|TWO_SIDED|95.0|0.756|1.12|||Log Rank|||||1.120|0.756|0.406
91609160|NCT01476787|183111753|SUPERIORITY||Hazard Ratio (HR)|1.038|||||TWO_SIDED|95.0|0.854|1.261||||||||1.261|0.854|
91609161|NCT01476787|183111754|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.775|1.395||||||||1.395|0.775|
91609162|NCT01476787|183111755|SUPERIORITY||Hazard Ratio (HR)|0.809|||||TWO_SIDED|95.0|0.651|1.006|||Regression, Cox|||||1.006|0.651|
91609163|NCT01477450|183111771|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.3
91609164|NCT01477450|183111771|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
91609165|NCT01477450|183111771|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
91609166|NCT00443560|183111791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.01||95.0|2.3|4.5|||Chi-squared, Corrected|||||4.5|2.3|<0.01
91609167|NCT00443560|183111792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.2|||<|0.01||95.0|9.9|15.0|||Chi-squared, Corrected|||||15.0|9.9|<0.01
91609168|NCT00443560|183111793|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91609169|NCT01494038|183111797|NON_INFERIORITY|Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.|Incidence rate difference|0.1|||||TWO_SIDED|95.0|-4.77|4.98||||||||4.98|-4.77|
91609170|NCT01494038|183111798|SUPERIORITY|||||||0.093|||||||Fisher Exact|mid-P adjustment||||||0.093
91609171|NCT01494038|183111800|SUPERIORITY|||||||0.288|||||||Fisher Exact|mid-P adjustment||||||0.288
91609172|NCT01494038|183111801|SUPERIORITY|||||||0.073|||||||Fisher Exact|mid-P adjustment||||||0.073
91609173|NCT01494038|183111802|SUPERIORITY|||||||0.264|||||||Fisher Exact|mid-P adjustment||||||0.264
91609174|NCT01494038|183111803|SUPERIORITY|||||||0.012|||||||Fisher Exact|Mid-P adjustment||||||0.012
91609175|NCT01494038|183111806|SUPERIORITY|||||||0.279|||||||Fisher Exact|mid-P adjustment||||||0.279
91609176|NCT01494038|183111807|SUPERIORITY|||||||0.893|||||||Fisher Exact|mid-P adjustment||||||.893
91609177|NCT01494038|183111808|SUPERIORITY||Incidence rate difference|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||||0.96|-0.94|
91609178|NCT01494038|183111809|SUPERIORITY||Incidence rate difference|0.02|||||TWO_SIDED|95.0|-1.02|1.07||||||||1.07|-1.02|
91609179|NCT01494038|183111810|SUPERIORITY||Incidence rate difference|-1.43|||||TWO_SIDED|95.0|-4.17|1.32||||||||1.32|-4.17|
91609180|NCT01494038|183111811|SUPERIORITY||Incidence rate difference|-0.39|||||TWO_SIDED|95.0|-1.33|0.56||||||||0.56|-1.33|
91609181|NCT01494038|183111812|SUPERIORITY||Incidence rate difference|-0.38|||||TWO_SIDED|95.0|-1.72|0.97||||||||0.97|-1.72|
91609182|NCT01494038|183111813|SUPERIORITY||Incidence rate difference|-1.69|||||TWO_SIDED|95.0|-4.48|1.1||||||||1.1|-4.48|
91609183|NCT01494038|183111814|SUPERIORITY||Incidence rate difference|-1.3|||||TWO_SIDED|95.0|-3.86|1.25||||||||1.25|-3.86|
91609184|NCT01494038|183111815|SUPERIORITY||Incidence rate difference|2.14|||||TWO_SIDED|95.0|-7.86|12.13||||||||12.13|-7.86|
91609185|NCT01494038|183111816|SUPERIORITY||Incidence rate difference|6.89|||||TWO_SIDED|95.0|-0.08|13.86||||||||13.86|-0.08|
91609186|NCT01494038|183111817|SUPERIORITY||Incidence rate difference|5.49|||||TWO_SIDED|95.0|-13.7|24.68||||||||24.68|-13.7|
91609187|NCT01494038|183111818|SUPERIORITY||Incidence rate difference|15.88|||||TWO_SIDED|95.0|2.11|29.65||||||||29.65|2.11|
91609188|NCT01494038|183111819|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
91609189|NCT01494038|183111820|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
91609190|NCT01494038|183111821|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
91609191|NCT01494038|183111822|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
91609192|NCT01494038|183111823|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
91609193|NCT01494038|183111824|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
91609194|NCT01494038|183111825|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
91609195|NCT01494038|183111826|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
91609196|NCT01494038|183111831|OTHER|Measuring agreement between the tests|||||<|0.0001|||||||Chi-squared|McNemars test||||||< 0.0001
91609197|NCT01494038|183111831|OTHER|Agreement between tests|Kappa coefficient|0.42|||||TWO_SIDED|95.0|0.35|0.5||||||||0.50|0.35|
91609198|NCT01494038|183111832|OTHER|Agreement between tests||||||0.22|||||||Chi-squared|McNemar's test||||||0.22
91609199|NCT01494038|183111832|OTHER|Agreement between tests|Kappa coefficient|0.11|||||TWO_SIDED|95.0|0.001|0.21||||||||0.21|0.001|
91609200|NCT01494038|183111833|OTHER|Agreement between tests|||||<|0.0001|||||||Chi-squared|McNemar's test||||||< 0.0001
91609201|NCT01494038|183111833|OTHER|Agreement between tests|Kappa coefficient|0.46|||||TWO_SIDED|95.0|0.39|0.53||||||||0.53|0.39|
91609202|NCT00537940|183111836|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.8708|TWO_SIDED|95.0|-6.0|7.0|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between Baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||7.0|-6.0|0.8708
91788467|NCT02390791|183457531|SUPERIORITY|||||||0.04|||||||generalized linear model|assuming a Poisson distribution with a log link function||||||0.04
91788468|NCT02390791|183457532|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91609203|NCT00537940|183111837|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.662|TWO_SIDED|95.0|0.635|1.335|||Regression, Logistic|||The odds ratio and its 95% CI are calculated by exponentiating the log odds ratio and 95% CI that correspond to the treatment contrast in the logistic regression model with treatment as fixed effect and Baseline term and country as covariate. All statistical tests for secondary efficacy parameters were two sided and performed at significance level of α = 0.05. The above statistical analysis applies to All Partial Seizures - FAS Population.||1.335|0.635|0.662
91609204|NCT00537940|183111838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9232|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9232
91609205|NCT00537940|183111838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6361|TWO_SIDED|||||Simple Partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6361
91609206|NCT00537940|183111838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9075|TWO_SIDED|||||Complex partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9075
91609207|NCT00537940|183111838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4203|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4203
91609208|NCT00537940|183111839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5069|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.5069
91609209|NCT00537940|183111839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4721|TWO_SIDED|||||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4721
91609210|NCT00537940|183111839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6054|TWO_SIDED|||||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6054
91609211|NCT00537940|183111839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6603|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6603
91609212|NCT00537940|183111841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1881|TWO_SIDED|||||p-value is calculated using Fisher Exact Test.|Fisher Exact|||||||0.1881
91609213|NCT00537940|183111842|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.38||0.5643|TWO_SIDED|95.0|-0.53|0.97|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and and country as covariates.||0.97|-0.53|0.5643
91609214|NCT00537940|183111842|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.32||0.7712|TWO_SIDED|95.0|-0.73|0.54|||ANCOVA|||Change at Week 21 / ET , HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country as covariates.||0.54|-0.73|0.7712
91788469|NCT02390791|183457533|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
91788470|NCT02390791|183457534|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91788471|NCT02390791|183457535|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91788472|NCT02390791|183457536|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
91788473|NCT02390791|183457537|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91788474|NCT02390791|183457538|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
91788475|NCT02390791|183457539|SUPERIORITY|||||||0.48|||||||generalized linear model|||||||0.48
91788476|NCT02390791|183457540|SUPERIORITY|||||||0.71|||||||generalized linear model|||||||0.71
91788477|NCT00821509|183457543|SUPERIORITY_OR_OTHER||ratio of proportions|1.03||||0.004|||||||proportion test|The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm||According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.004
91788478|NCT00821509|183457544|SUPERIORITY_OR_OTHER||ratio of proportions|0.933||||0.04|||||||proportion test|||According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.04
91788479|NCT01551420|183457545|SUPERIORITY|Null hypothesis of no change after home use|Mean Difference (Net)|0.002|STANDARD_DEVIATION|0.68||0.9358|TWO_SIDED|95.0|-0.27|0.28||Two way comparison between scores at baseline and after 9-12 weeks of Prosthetic use. Alpha=0.05|t-test, 2 sided|paired t-tests||||0.28|-0.27|.9358
91788480|NCT01551420|183457545|SUPERIORITY||Slope|-0.69||||0.08|TWO_SIDED|95.0|-1.47|0.09|||Regression, Linear|||Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-1.47|0.08
91788481|NCT01551420|183457546|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.42|<|0.0001|TWO_SIDED|95.0|0.17|0.43|||t-test, 2 sided|The sample for this analyses was 44 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).||0.43|0.17|<0.0001
91788482|NCT01551420|183457546|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.73|-0.4|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.40|-0.73|<0.0001
91788483|NCT01551420|183457547|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_DEVIATION|0.94||0.186|TWO_SIDED|95.0|-0.55|0.11|||t-test, 2 sided|The sample for this analysis was 34 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).||0.11|-0.55|0.186
91791057|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.249||0.67|TWO_SIDED|95.0|-0.383|0.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.596|-0.383|0.670
91609215|NCT00537940|183111842|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.35||0.4236|TWO_SIDED|95.0|-0.41|0.97|||Ranked ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.97|-0.41|0.4236
91609216|NCT00537940|183111842|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5492|TWO_SIDED|95.0|-0.75|0.4|||Ranked ANCOVA|||Change at Week 21/ET, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment1difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.40|-0.75|0.5492
91609217|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.07||0.116|TWO_SIDED|95.0|-0.81|7.31|||ANCOVA|||Baseline Sleep disturbance: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||7.31|-0.81|0.1160
91609218|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.68||0.849|TWO_SIDED|95.0|-3.62|2.98|||ANCOVA|||Week 21 Sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.98|-3.62|0.8490
91609219|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|2.82||0.6728|TWO_SIDED|95.0|-4.34|6.73|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.73|-4.34|0.6728
91609220|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3954|TWO_SIDED|95.0|-2.56|6.47|||ANCOVA|||Week 21 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.47|-2.56|0.3954
91609221|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|4.03|STANDARD_ERROR_OF_MEAN|2.52||0.1106|TWO_SIDED|95.0|-0.92|8.98|||ANCOVA|||Baseline Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||8.98|-0.92|0.1106
91653351|NCT01533428|183199512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.595|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.4|-0.7|0.595
91653352|NCT01533428|183199514|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.03|TWO_SIDED|95.0|-17.2|-0.9|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-0.9|-17.2|0.030
91609222|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.11||0.3603|TWO_SIDED|95.0|-6.09|2.22|||ANCOVA|||Week 21 Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.22|-6.09|0.3603
91609223|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8312|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Baseline Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.24|-0.30|0.8312
91653353|NCT01533428|183199514|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5||||0.02|TWO_SIDED|95.0|-17.4|-1.5|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.5|-17.4|0.020
91788484|NCT01551420|183457547|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|0.44||0.0168|TWO_SIDED|95.0|-2.06|-0.23|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.23|-2.06|0.0168
91788485|NCT01551420|183457548|SUPERIORITY||Mean Difference (Net)|-0.97|STANDARD_DEVIATION|5.61||0.3367|TWO_SIDED|95.0|-2.99|1.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||1.05|-2.99|0.3367
91788486|NCT01551420|183457548|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.49||0.6339|TWO_SIDED|95.0|-3.84|2.39|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.39|-3.84|0.6339
91788487|NCT01551420|183457549|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_DEVIATION|18.8||0.5465|TWO_SIDED|95.0|-7.53|4.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).||4.05|-7.53|0.5465
91523555|NCT02036645|182923013|SUPERIORITY_OR_OTHER||Slope|0.96|||||TWO_SIDED|95.0|0.65|1.27|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.27|0.65|
91791058|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91609224|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.38|0.42|||ANCOVA|||Week 21 Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.42|-0.38|0.9101
91609225|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|2.45||0.3346|TWO_SIDED|95.0|-7.19|2.45|||ANCOVA|||Baseline Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.45|-7.19|0.3346
91609226|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|2.05||0.7491|TWO_SIDED|95.0|-4.69|3.37|||ANCOVA|||Week 21 Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||3.37|-4.69|0.7491
91609227|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|1.9||0.1162|TWO_SIDED|95.0|-0.74|6.71|||ANCOVA|||Baseline Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.71|-0.74|0.1162
91609228|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|1.66||0.2163|TWO_SIDED|95.0|-1.21|5.32|||ANCOVA|||Week 21 Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||5.32|-1.21|0.2163
91609229|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.45|STANDARD_ERROR_OF_MEAN|1.61||0.0321|TWO_SIDED|95.0|0.3|6.61|||ANCOVA|||Baseline Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.61|0.30|0.0321
91609230|NCT00537940|183111843|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|1.28||0.7889|TWO_SIDED|95.0|-2.17|2.85|||ANCOVA|||Week 21 Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.85|-2.17|0.7889
91609231|NCT00537940|183111844|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.653||||0.0252|TWO_SIDED|95.0|0.449|0.948|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||0.948|0.449|0.0252
91609232|NCT00537940|183111844|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.811||||0.3459|TWO_SIDED|95.0|0.524|1.254|||Regression, Logistic|||Week 21: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.254|0.524|0.3459
91609233|NCT03715465|183111854|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
91609234|NCT03715465|183111855|SUPERIORITY|||||||0.411|||||||t-test, 2 sided|||Per diary||||0.411
91609235|NCT03715465|183111855|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Per wrist actigraphy||||0.920
91609236|NCT03715465|183111856|SUPERIORITY|||||||0.787|||||||t-test, 2 sided|||Per diary||||0.787
91609237|NCT03715465|183111856|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Per wrist actigraphy||||0.916
91609238|NCT03715465|183111857|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Per diary||||0.270
91609239|NCT03715465|183111857|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||Per wrist actigraphy||||0.406
91609240|NCT03715465|183111858|SUPERIORITY|||||||0.635|||||||t-test, 2 sided|||Per diary||||0.635
91609241|NCT03715465|183111858|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||Per wrist actigraphy||||0.383
91609242|NCT03715465|183111859|SUPERIORITY|||||||0.456|||||||t-test, 2 sided|||||||0.456
91609243|NCT03715465|183111860|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||||||0.402
91609244|NCT03715465|183111861|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
91609245|NCT03715465|183111862|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
91609246|NCT03715465|183111863|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
91609247|NCT03715465|183111864|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
91609248|NCT03715465|183111865|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91609249|NCT03715465|183111866|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||||||0.246
91609250|NCT03715465|183111867|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||||||0.333
91609251|NCT00430781|183111896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.535||90.0|0.65|1.7||Stratified log-rank test with one-sided p-value. p\<=0.0037 required for significance, and p\>0.4956 indicated futility.|Log Rank||The estimated value is the hazard ratio comparing combination to lapatinib monotherapy|||1.7|0.65|0.535
91788488|NCT01551420|183457549|SUPERIORITY||Mean Difference (Net)|-3.78|STANDARD_DEVIATION|17.37||0.161|TWO_SIDED|95.0|-9.12|1.57|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).||1.57|-9.12|0.1610
91788489|NCT01551420|183457549|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_DEVIATION|13.9||0.7765|TWO_SIDED|95.0|-4.9|3.68|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).||3.68|-4.90|0.7765
91788490|NCT01551420|183457549|SUPERIORITY||Slope|-13.35|STANDARD_ERROR_OF_MEAN|6.91||0.0669|TWO_SIDED|95.0|-27.72|1.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.02|-27.72|0.0669
91788491|NCT01551420|183457549|SUPERIORITY||Slope|-8.24|STANDARD_ERROR_OF_MEAN|7.1||0.2592|TWO_SIDED|95.0|-23.01|6.54|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||6.54|-23.01|0.2592
91788492|NCT01551420|183457549|SUPERIORITY||Slope|-30.23|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|-43.23|-17.23|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-17.23|-43.23|<0.0001
91788493|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.17||0.6691|TWO_SIDED|95.0|-0.05|0.07|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).||0.07|-0.05|0.6691
91788494|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.06||0.0511|TWO_SIDED|95.0|-0.05|0.0|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).||0.00|-0.05|0.0511
91788495|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.09||0.5942|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).||0.04|-0.02|0.5942
91788496|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.08||0.0101|TWO_SIDED|95.0|-0.07|-0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).||-0.01|-0.07|0.0101
91788497|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.09||0.1063|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).||0.01|-0.06|0.1063
91609252|NCT00430781|183111899|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||One-sided p-value.|Fisher Exact|||||||0.237
91609253|NCT00430781|183111903|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.66||||0.013||90.0|0.48|0.91||Stratified log-rank test with one-sided p-value.|Log Rank|||||0.91|0.48|0.013
91609254|NCT01389128|183111907|OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
91609255|NCT01389128|183111910|OTHER|||||||0.68|||||||Chi-squared|||||||0.68
91609256|NCT01532453|183111936|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED|||||Rank ANCOVA With treatment, center, gender, transplanted organ as factors and age of organ transplant as a covariable.|ANCOVA|||||||0.0278
91609257|NCT01532453|183111937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579|||<|0.05|TWO_SIDED|95.0|0.2703|1.2405|||ANCOVA|||||1.2405|0.2703|<0.05
91609258|NCT03230097|183111938|OTHER||Hazard Ratio (HR)|0.849||||0.7873|TWO_SIDED|95.0|0.258|2.795|||Regression, Cox|Stratified (by baseline use of antipsychotic medication) Cox proportional hazards model was used. Treatment effect and NAPLS risk score as covariates.|Ratio = BI 409306/placebo.|||2.795|0.258|0.7873
91609259|NCT03230097|183111940|OTHER||Adjusted mean difference|1.77||||0.5212|TWO_SIDED|95.0|-3.773|7.315|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 24. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||7.315|-3.773|0.5212
91609260|NCT03230097|183111940|OTHER||Adjusted mean difference|3.18||||0.3127|TWO_SIDED|95.0|-3.071|9.425|||Mixed Models Analysis||Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM), see endpoint description for details.|BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||9.425|-3.071|0.3127
91609261|NCT03230097|183111941|OTHER||Adjusted mean difference|-4.99||||0.1602|TWO_SIDED|95.0|-12.033|2.057|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.057|-12.033|0.1602
91788498|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.12||0.2474|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).||0.01|-0.06|0.2474
91788499|NCT01551420|183457550|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.14||0.1604|TWO_SIDED|95.0|-0.09|0.02|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).||0.02|-0.09|0.1604
91609262|NCT03230097|183111942|OTHER||Adjusted mean difference|-0.8||||0.5858|TWO_SIDED|95.0|-3.749|2.153|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, positive items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.153|-3.749|0.5858
91609263|NCT03230097|183111942|OTHER||Adjusted mean difference|1.43||||0.3445|TWO_SIDED|95.0|-1.604|4.462|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, negative items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||4.462|-1.604|0.3445
91609264|NCT03230097|183111942|OTHER||Adjusted mean difference|1.71||||0.7154|TWO_SIDED|95.0|-7.772|11.196|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, total score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||11.196|-7.772|0.7154
91609265|NCT05740813|183111949|SUPERIORITY||Disease Rate Ratio|1.06|STANDARD_DEVIATION|0.12|||TWO_SIDED|95.0|0.85|1.324||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. ABBV-CLS-7262 slowed progression) was 0.3117 for Dose 1. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter mode|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by ABBV-CLS-7262 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model incorporates participant-level random effects in the baseline value of the ALSFRS-R (intercept) and in the rate of progression (slope); covariate effects to account for covariate-explainable differences in rates of progression based on participant-specific baseline covariates; regimen-specific differences in baseline values, rates of progression and measurement error. Covariates include time since onset of symptoms, pre-baseline slope of ALSFRS-R, riluzole, edaravone, and Relyvrio use at the time of baseline as indicated in concomitant medication logs, and log-transformed baseline serum NfL.|1.324|0.850|
91613279|NCT01254604|183121040|NON_INFERIORITY_OR_EQUIVALENCE|The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.|Difference in Least Squares Means|-1.7|||||TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|Analysis model includes terms for treatment, baseline IOP and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Difference is tafluprost - timolol|The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost - timolol) was ≤1.5 mmHg.||-0.7|-2.6|
91609266|NCT05740813|183111949|SUPERIORITY||Disease Rate Ratio|0.96|STANDARD_DEVIATION|0.119|||TWO_SIDED|95.0|0.753|1.22||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. ABBV-CLS-7262 slowed progression) was 0.6426. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by ABBV-CLS-7262 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model incorporates participant-level random effects in the baseline value of the ALSFRS-R (intercept) and in the rate of progression (slope); covariate effects to account for covariate-explainable differences in rates of progression based on participant-specific baseline covariates; regimen-specific differences in baseline values, rates of progression and measurement error. Covariates include time since onset of symptoms, pre-baseline slope of ALSFRS-R, riluzole, edaravone, and Relyvrio use at the time of baseline as indicated in concomitant medication logs, and log-transformed baseline serum NfL.|1.220|0.753|
91609267|NCT05740813|183111950|SUPERIORITY||Mean Difference (Net)|-0.547|STANDARD_ERROR_OF_MEAN|0.5639||0.3325|TWO_SIDED|95.0|-1.657|0.562|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 1 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|0.562|-1.657|0.3325
91609268|NCT05740813|183111950|SUPERIORITY||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.6732||0.8878|TWO_SIDED|95.0|-1.23|1.42|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 2 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|1.420|-1.230|0.8878
91609269|NCT05740813|183111951|SUPERIORITY||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|2.1066||0.5008|TWO_SIDED|95.0|-5.563|2.723|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 1 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|2.723|-5.563|0.5008
91609270|NCT05740813|183111951|SUPERIORITY||Mean Difference (Net)|2.261|STANDARD_ERROR_OF_MEAN|2.5292||0.3721|TWO_SIDED|95.0|-2.714|7.236|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 2 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|7.236|-2.714|0.3721
91609271|NCT05740813|183111953|SUPERIORITY||Mean Difference (Net)|1.796|STANDARD_ERROR_OF_MEAN|4.222||0.6707|TWO_SIDED|95.0|-6.506|10.099|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 1 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|10.099|-6.506|0.6707
91609272|NCT05740813|183111953|SUPERIORITY||Mean Difference (Net)|12.318|STANDARD_ERROR_OF_MEAN|5.011||0.0144|TWO_SIDED|95.0|2.463|22.172|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 2 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|22.172|2.463|0.0144
91791059|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.256||0.95|TWO_SIDED|95.0|-0.486|0.519||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.519|-0.486|0.950
91791060|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.04|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91791061|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.257||0.383|TWO_SIDED|95.0|-0.729|0.281||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.281|-0.729|0.383
91791062|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791063|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.254||0.985|TWO_SIDED|95.0|-0.504|0.494||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.494|-0.504|0.985
91791064|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791065|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.256||0.064|TWO_SIDED|95.0|-0.982|0.027||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.027|-0.982|0.064
91609273|NCT05740813|183111954|SUPERIORITY||Mean Difference (Net)|1.092||||0.0253|TWO_SIDED|95.0|1.011|1.179|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|Least squares mean difference between ABBV-CLS-7262 Dose 1 24-week change from baseline and placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|1.179|1.011|0.0253
91653354|NCT00095199|183199528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.756|TWO_SIDED|95.0|0.87|1.21||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.21|0.87|0.756
91653355|NCT00095199|183199528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.391|TWO_SIDED|95.0|0.73|1.13||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.13|0.73|0.391
91653356|NCT00095199|183199529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.864|TWO_SIDED|95.0|0.86|1.2||The 2-sided unstratified log-rank test was employed at the 5% significance level|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.20|0.86|0.864
91609274|NCT05740813|183111954|SUPERIORITY||Mean Difference (Net)|1.073||||0.1364|TWO_SIDED|95.0|0.978|1.175|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|Least squares mean difference between ABBV-CLS-7262 Dose 2 24-week change from baseline and placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|1.175|0.978|0.1364
91653357|NCT00095199|183199529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.307|TWO_SIDED|95.0|0.9|1.41||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.41|0.90|0.307
91653358|NCT00095199|183199530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.2|TWO_SIDED|95.0|0.78|3.26||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.26|0.78|0.200
91653359|NCT00095199|183199530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.683|TWO_SIDED|95.0|0.52|2.74||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.74|0.52|0.683
91653360|NCT00095199|183199531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.62|0.86|0.310
91653361|NCT00095199|183199531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1|TWO_SIDED|95.0|0.93|2.4||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.40|0.93|0.100
91791066|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|2.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791067|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.28||0.527|TWO_SIDED|95.0|-0.374|0.729||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.729|-0.374|0.527
91523556|NCT00279201|182923043|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.||||||0.005
91653362|NCT00095199|183199532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.091|TWO_SIDED|95.0|0.46|1.06||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.06|0.46|0.091
91653363|NCT00095199|183199532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.361|TWO_SIDED|95.0|0.72|2.5||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.50|0.72|0.361
91653364|NCT00095199|183199533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.472|TWO_SIDED|95.0|0.77|1.74||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.74|0.77|0.472
91609275|NCT05740813|183111955|SUPERIORITY||Mean Difference (Net)|-0.058|STANDARD_ERROR_OF_MEAN|2.1327||0.9782|TWO_SIDED|95.0|-4.254|4.137|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 1 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|4.137|-4.254|0.9782
91609276|NCT05740813|183111955|SUPERIORITY||Mean Difference (Net)|-1.652|STANDARD_ERROR_OF_MEAN|2.5101||0.5108|TWO_SIDED|95.0|-6.59|3.286|||Mixed Models Analysis|Covariates: baseline (BL) use edaravone, riluzole, Relyvrio, BL log-trans. NfL, SVC, time since onset, pre-BL ALSFRS-R slope, interactions with visit|ABBV-CLS-7262 Dose 2 24-week change from baseline relative to placebo 24-week change from baseline.||Model adjusted for covariates including baseline (BL) use of edaravone, riluzole and Relyvrio, BL log-transformed NfL, and SVC, time since onset, pre-BL ALSFRS-R slope and interaction with visit.|3.286|-6.590|0.5108
91609277|NCT05740813|183111956|SUPERIORITY|||||||0.6481|||||||Log Rank|Dose 1. See Other Statistical Analysis for model adjustment details.|||Cox proportional hazards model adjusted for age at baseline, time since ALS symptom onset, delta FRS, baseline log-transformed serum NfL level, use of riluzole at baseline, use of riluzole at baseline, and use of Relyvrio at baseline.|||0.6481
91609278|NCT05740813|183111956|SUPERIORITY|||||||0.6344|||||||Log Rank|Dose 2. See Other Statistical Analysis for model adjustment details.|||Cox proportional hazards model adjusted for age at baseline, time since ALS symptom onset, delta FRS, baseline log-transformed serum NfL level, use of riluzole at baseline, use of riluzole at baseline, and use of Relyvrio at baseline.|||0.6344
91609279|NCT02439775|183111976|SUPERIORITY|||||||0.1194||||||p\<0.05 required for significance|ANCOVA|||||||0.1194
91609280|NCT05483127|183112005|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference=P1fA - MDT. Sign (negative or positive) is retained with the rounded value.|||-0.00||
91609281|NCT02951273|183112006|SUPERIORITY|||||||0.0276|||||||repeated measure mixed model|||||||0.0276
91609282|NCT02951273|183112007|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
91609283|NCT02951273|183112008|SUPERIORITY|||||||0.6025|||||||Regression, Linear|||||||0.6025
91609284|NCT02951273|183112009|SUPERIORITY|||||||0.3213|||||||repeated measure mixed model|||||||0.3213
91609285|NCT02951273|183112010|SUPERIORITY|||||||0.0005||||||The reported p-value was calculated|repeated measure mixed model|||||||0.0005
91609286|NCT02951273|183112011|SUPERIORITY|||||||0.5404|||||||repeated measure mixed model|||||||0.5404
91609287|NCT02951273|183112012|SUPERIORITY|||||||0.8947|||||||repeated measure mixed model|||||||0.8947
91609288|NCT02951273|183112013|SUPERIORITY|||||||0.0068|||||||Linear mixed models|||||||0.0068
91609289|NCT02951273|183112014|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
91609290|NCT02951273|183112015|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91609291|NCT02951273|183112016|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
91609292|NCT02951273|183112017|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
91609293|NCT00121225|183112022|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
91609294|NCT00440401|183112083|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0001
91609295|NCT00440401|183112084|SUPERIORITY_OR_OTHER||||||<|0.0006||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0006
91609296|NCT03291197|183112112|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.||||0.043
91609297|NCT04246047|183112114|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|1e-05||95.0|0.31|0.53|||one-sided stratified log-rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.53|0.31|<0.00001
91609298|NCT00780403|183112174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
91609299|NCT00624338|183112211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.518|TWO_SIDED|95.0|0.74|1.82||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.82|0.74|0.518
91788500|NCT01551420|183457550|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.4208|TWO_SIDED|95.0|-0.12|0.09|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-0.12|0.4208
91788501|NCT01551420|183457550|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1959|TWO_SIDED|95.0|-0.09|0.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.02|-0.09|0.1959
91788502|NCT01551420|183457550|SUPERIORITY|Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3328|TWO_SIDED|95.0|-0.09|0.03|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.03|-0.09|0.3328
91523557|NCT00279201|182923044|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|Stratified by country, thiazolidinedione (TZD) use, sulfo use.||||||0.040
91788503|NCT01551420|183457550|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6585|TWO_SIDED|95.0|-0.05|0.08|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.08|-0.05|0.6585
91788504|NCT01551420|183457550|SUPERIORITY|Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0552|TWO_SIDED|95.0|-0.12|0.0|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.00|-0.12|0.0552
91788505|NCT01551420|183457550|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0319|TWO_SIDED|95.0|-0.25|-0.01|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.01|-0.25|0.0319
91788506|NCT01551420|183457550|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0073|TWO_SIDED|95.0|-0.24|-0.04|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.04|-0.24|0.0073
91788507|NCT01551420|183457551|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.52||0.6529|TWO_SIDED|95.0|-0.24|0.15|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).||0.15|-0.24|0.6529
91788508|NCT01551420|183457551|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.64||0.849|TWO_SIDED|95.0|-0.26|0.22|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).||0.22|-0.26|0.8490
91788509|NCT01551420|183457551|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.17||0.4589|TWO_SIDED|95.0|-0.22|0.48|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.48|-0.22|0.4589
91788510|NCT01551420|183457551|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.18||0.711|TWO_SIDED|95.0|-0.31|0.44|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.44|-0.31|0.7110
91788511|NCT01551420|183457552|SUPERIORITY||Mean Difference (Net)|253.6|STANDARD_DEVIATION|325.2|<|0.0001|TWO_SIDED|95.0|146.7|360.5|||t-test, 2 sided|The sample for this paired t-test was 38 participants.||Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).|Mean difference is the change in scores from Baseline to End of A.|360.5|146.7|<0.0001
91609300|NCT00624338|183112211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.003|TWO_SIDED|95.0|0.31|0.78||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.78|0.31|0.003
91609301|NCT00624338|183112212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.929|TWO_SIDED|95.0|0.69|1.4||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|||||1.40|0.69|0.929
91609302|NCT00624338|183112212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.562||||0.009|TWO_SIDED|95.0|0.36|0.87||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.87|0.36|0.009
91609303|NCT00624338|183112213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.412|TWO_SIDED|95.0|0.76|1.94||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.94|0.76|0.412
91609304|NCT00624338|183112213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.722||||0.198|TWO_SIDED|95.0|0.44|1.19||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||1.19|0.44|0.198
91653365|NCT00095199|183199533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.272|TWO_SIDED|95.0|0.42|1.27||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.27|0.42|0.272
91653366|NCT00095199|183199534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.236|TWO_SIDED|95.0|0.74|3.36||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.36|0.74|0.236
91653367|NCT00095199|183199534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.42|2.18||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.18|0.42|0.887
91609305|NCT03476850|183112216|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.883|TWO_SIDED||||||Mixed Models Analysis|||An a priori sample size calculation found 24 subjects per group (48 total) provided \>80% power to detect a 2 unit difference in patient reported pain based on a 2-sided test and significance level a = 0.05 assuming at least 3 measures per subject and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 3 units and within subject correlation of 0.5.||||.883
91609306|NCT03476850|183112217|SUPERIORITY||Median Difference (Final Values)|0.25||||0.977|TWO_SIDED||||||ANOVA|||||||.977
91609307|NCT03476850|183112218|SUPERIORITY||Odds Ratio (OR)|4.9||||0.009|TWO_SIDED||||||Chi-squared|||||||.009
91609308|NCT03476850|183112220|SUPERIORITY||Median Difference (Final Values)|18.0||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.110
91523558|NCT00279201|182923045|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
91609309|NCT03476850|183112221|SUPERIORITY||Median Difference (Final Values)|0.26||||0.719|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.719
91609310|NCT02912364|183112222|OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||t-test, 2 sided|degrees of freedom = 22||||.34|.13|< .001
91609311|NCT02912364|183112223|OTHER||Mean Difference (Final Values)|0.54|||<|0.001|TWO_SIDED|95.0|0.3|0.79|||t-test, 2 sided|Degrees of freedom = 22.||||.79|.30|< .001
91609312|NCT00144300|183112245|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||||95.0|0.71|1.6||||||||1.60|0.71|
91609313|NCT01225068|183112310|SUPERIORITY_OR_OTHER||effect size|0.22||||||||||no p value for effect size calculations ES is dimensionless; ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (here at baseline and 6 weeks) divided by the pooled standard deviation.|effect size is endpoint and not comparis|no p value for effect size calculations||effect size is endpoint and not comparison||||
91609314|NCT05165394|183112314|SUPERIORITY||Least-Squares Mean Treatment Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.5||0.8663|ONE_SIDED|90.0|-8.4|||Significance level = 0.1|ANCOVA||Confidence interval and p-value are one-sided for test of null hypothesis that the LS mean difference between NBI-1065846 and placebo in DARS total score at Day 57 is greater than or equal to zero.||||-8.4|0.8663
91609315|NCT05165394|183112315|SUPERIORITY||Least-Squares Mean Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.0||0.7008|TWO_SIDED|95.0|-7.1|4.8|||ANCOVA||NBI-1065846 - Placebo|||4.8|-7.1|0.7008
91609316|NCT05165394|183112316|SUPERIORITY|||||||0.9051|||||||Cochran-Mantel-Haenszel Chi-square test|||CGI-S scores at Day 57 for NBI-1065846 compared to placebo.||||0.9051
91609317|NCT02495077|183112322|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.099|TWO_SIDED|95.0|-10.73|0.93|||Mixed Models Analysis|||Mean eGFR of the two treatment groups was compared. The p-value, estimated month 24 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence intervals result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group. Random effects for the intercept and eGFR collection day were utilized in the model.||0.93|-10.73|0.099
91609318|NCT02495077|183112323|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91609319|NCT02495077|183112324|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91609320|NCT02495077|183112326|SUPERIORITY|||||||0.746|||||||Fisher Exact|||||||0.746
91609321|NCT02495077|183112327|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.242
91609322|NCT02495077|183112329|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91609323|NCT02495077|183112330|SUPERIORITY|||||||0.497|||||||Fisher Exact|||||||0.497
91609324|NCT02495077|183112331|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
91609325|NCT02495077|183112333|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
91609326|NCT02495077|183112334|SUPERIORITY|||||||0.135|||||||Cochran-Mantel-Haenszel|||||||0.135
91609327|NCT02495077|183112335|SUPERIORITY|||||||0.157|||||||Chi-squared|||||||0.157
91609328|NCT02495077|183112336|SUPERIORITY|||||||0.071|||||||Chi-squared|||||||0.071
91609329|NCT02495077|183112337|SUPERIORITY|||||||0.543|||||||t-test, 2 sided|||||||0.543
91609330|NCT02495077|183112338|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
91609331|NCT02495077|183112339|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||0.275
91609332|NCT02495077|183112340|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.300
91609333|NCT02495077|183112341|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||||||0.152
91609334|NCT02495077|183112342|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||||||0.181
91609335|NCT02495077|183112343|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.639|TWO_SIDED|95.0|-5.37|3.3|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.30|-5.37|0.639
91609336|NCT02495077|183112344|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.51|TWO_SIDED|95.0|-6.22|3.1|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.10|-6.22|0.510
91609337|NCT02495077|183112344|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.43|TWO_SIDED|95.0|-6.45|2.76|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||2.76|-6.45|0.430
91788512|NCT01551420|183457552|SUPERIORITY||Slope|-183.1|STANDARD_ERROR_OF_MEAN|186.9||0.3397|TWO_SIDED|95.0|-574.3|208.2|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||208.2|-574.3|0.3397
91609338|NCT02495077|183112344|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.328|TWO_SIDED|95.0|-6.86|2.31|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.31|-6.86|0.328
91609339|NCT02495077|183112345|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.725|TWO_SIDED|95.0|-5.58|3.89|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.89|-5.58|0.725
91653368|NCT00717977|183199547|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.009
91653369|NCT00717977|183199548|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.04
91653370|NCT00717977|183199549|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Adjusted for device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||<0.001
91653371|NCT01806688|183199604|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
91653372|NCT01806688|183199605|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
91788513|NCT01551420|183457553|SUPERIORITY||Mean Difference (Net)|4.3|STANDARD_DEVIATION|10.01||0.0465|TWO_SIDED|95.0|0.07|8.53|||t-test, 2 sided|The sample for this paired t-test was 24 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||8.53|0.07|0.0465
91788514|NCT01551420|183457553|SUPERIORITY||Slope|-2.39|STANDARD_ERROR_OF_MEAN|2.46||0.345|TWO_SIDED|95.0|-7.6|2.82|||Regression, Linear|The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.82|-7.60|0.3450
91788515|NCT01551420|183457554|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_DEVIATION|7.54||0.6881|TWO_SIDED|95.0|-1.86|2.79|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).||2.79|-1.86|0.6881
91788516|NCT01551420|183457554|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|13.95||0.7363|TWO_SIDED|95.0|-5.01|3.67|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).||3.67|-5.01|0.7363
91653373|NCT01806688|183199607|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
91653374|NCT02146430|183199608|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.187||0.187|TWO_SIDED|95.0|-0.61|0.12|||Difference of means|||||0.12|-0.61|0.1870
91653375|NCT02146430|183199608|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.0944|TWO_SIDED|95.0|-0.67|0.05|||Difference of means|||||0.05|-0.67|0.0944
91653376|NCT02146430|183199608|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.187||0.1391|TWO_SIDED|95.0|-0.64|0.09|||Difference of means|||||0.09|-0.64|0.1391
91788517|NCT01551420|183457554|SUPERIORITY||Mean Difference (Net)|-1.49|STANDARD_DEVIATION|8.12||0.2361|TWO_SIDED|95.0|-3.99|1.01|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).||1.01|-3.99|0.2361
91791068|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91653377|NCT02146430|183199608|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7338|TWO_SIDED|95.0|-0.43|0.3|||Difference of means|||||0.30|-0.43|0.7338
91653378|NCT02146430|183199608|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8705|TWO_SIDED|95.0|-0.4|0.34|||Difference of means|||||0.34|-0.40|0.8705
91653379|NCT02146430|183199610|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.592||0.0326|TWO_SIDED|95.0|-6.52|-0.28|||Difference of means|||||-0.28|-6.52|0.0326
91791069|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|0.31|STANDARD_ERROR_OF_MEAN|0.275||0.254|TWO_SIDED|95.0|-0.226|0.854||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.854|-0.226|0.254
91791070|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|2.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791071|NCT02880956|183460093|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.284||0.805|TWO_SIDED|95.0|-0.628|0.488||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.488|-0.628|0.805
91791072|NCT02880956|183460093|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791073|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.361||0.534|TWO_SIDED|95.0|-0.935|0.485||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.485|-0.935|0.534
91791074|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791075|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.356||0.735|TWO_SIDED|95.0|-0.58|0.821||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.821|-0.580|0.735
91791076|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791077|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.365||0.009|TWO_SIDED|95.0|-1.673|-0.24||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.240|-1.673|0.009
91791078|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.35|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91788518|NCT01551420|183457554|SUPERIORITY||Slope|-7.07|STANDARD_ERROR_OF_MEAN|4.02||0.0932|TWO_SIDED|95.0|-15.43|1.29|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.29|-15.43|0.0932
91788519|NCT01551420|183457554|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|6.0||0.0951|TWO_SIDED|95.0|-22.9|1.99|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.99|-22.9|0.0951
91788520|NCT01551420|183457554|SUPERIORITY||Slope|-4.91|STANDARD_ERROR_OF_MEAN|4.01||0.2346|TWO_SIDED|95.0|-13.3|3.43|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||3.43|-13.3|0.2346
91788521|NCT03073733|183457620|SUPERIORITY||least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.9||0.582|TWO_SIDED|95.0|-10.3|5.8|||linear model for repeated measures|||||5.8|-10.3|0.582
91788522|NCT03073733|183457620|SUPERIORITY||least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.91||0.984|TWO_SIDED|95.0|-8.2|8.0|||linear model for repeated measures|||||8.0|-8.2|0.984
91788523|NCT03073733|183457621|SUPERIORITY||least squares mean difference|1.2986|STANDARD_ERROR_OF_MEAN|0.8744||0.29|TWO_SIDED|95.0|-1.1341|3.7313|||linear model for repeated measures|||||3.7313|-1.1341|0.290
91609340|NCT02495077|183112346|SUPERIORITY||Mean Difference (Final Values)|-1.35||||0.601|TWO_SIDED|95.0|-6.41|3.72|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.72|-6.41|0.601
91609341|NCT02495077|183112346|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.519|TWO_SIDED|95.0|-6.66|3.37|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||3.37|-6.66|0.519
91609342|NCT02495077|183112346|SUPERIORITY||Mean Difference (Final Values)|-2.09||||0.411|TWO_SIDED|95.0|-7.08|2.91|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.91|-7.08|0.411
91609343|NCT02495077|183112347|SUPERIORITY|||||||0.569|||||||Chi-squared|||||||0.569
91609344|NCT02495077|183112348|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91609345|NCT02495077|183112349|SUPERIORITY|||||||0.451|||||||Chi-squared|||||||0.451
91609346|NCT02495077|183112350|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
91609347|NCT02495077|183112351|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.710
91609348|NCT02495077|183112352|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
91609349|NCT02495077|183112353|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.256|TWO_SIDED|95.0|-0.36|1.35|||Mixed Models Analysis|||24 Hours/Day 1. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 24 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 24 hours/day 1. A random effect for the intercept was utilized in the model.||1.35|-0.36|0.256
91609350|NCT02495077|183112353|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.391|TWO_SIDED|95.0|-0.48|1.23|||Mixed Models Analysis|||48 Hours/Day 2. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 48 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 48 hours/day 2. A random effect for the intercept was utilized in the model.||1.23|-0.48|0.391
91609351|NCT02495077|183112353|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.199|TWO_SIDED|95.0|-0.3|1.42|||Mixed Models Analysis|||72 Hours/Day 3. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 72 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 72 hours/day 3. A random effect for the intercept was utilized in the model.||1.42|-0.30|0.199
91609352|NCT02495077|183112354|SUPERIORITY|||||||0.812|||||||Log Rank|||||||0.812
91609353|NCT02495077|183112355|SUPERIORITY|||||||0.576|||||||Chi-squared|||||||0.576
91609354|NCT02495077|183112356|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||0.311
91609355|NCT02495077|183112357|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
91609356|NCT02495077|183112358|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
91653380|NCT02146430|183199610|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|1.592||0.422|TWO_SIDED|95.0|-4.4|1.84|||Difference of means|||||1.84|-4.40|0.4220
91653381|NCT02146430|183199610|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.615||0.9659|TWO_SIDED|95.0|-3.1|3.23|||Difference of means|||||3.23|-3.10|0.9659
91653382|NCT02146430|183199610|SUPERIORITY||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|1.608||0.1867|TWO_SIDED|95.0|-1.03|5.28|||Difference of means|||||5.28|-1.03|0.1867
91653383|NCT02146430|183199610|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.631||0.0333|TWO_SIDED|95.0|0.27|6.67|||Difference of means|||||6.67|0.27|0.0333
91609357|NCT02495077|183112359|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
91653384|NCT02146430|183199612|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2474|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||||0.2|-0.9|0.2474
91653385|NCT02146430|183199612|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3347|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.3347
91653386|NCT02146430|183199612|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3999|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||||0.8|-0.3|0.3999
91653387|NCT02146430|183199612|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8435|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.8435
91653388|NCT02146430|183199612|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0446|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||||1.1|0.0|0.0446
91523559|NCT00279201|182923045|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
91609358|NCT02495077|183112360|SUPERIORITY|||||||0.171|||||||Fisher Exact|||||||0.171
91609359|NCT02495077|183112361|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
91609360|NCT02495077|183112362|SUPERIORITY|||||||0.572|||||||Chi-squared|||||||0.572
91609361|NCT02495077|183112363|SUPERIORITY|||||||0.973|||||||Chi-squared|||||||0.973
91609362|NCT02495077|183112364|SUPERIORITY|||||||0.152|||||||Chi-squared|||||||0.152
91609363|NCT02495077|183112365|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91609364|NCT02495077|183112366|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91653389|NCT02146430|183199613|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9775|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.5|-0.5|0.9775
91653390|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.65|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.6|0.6500
91653391|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6546|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.4|-0.6|0.6546
91653392|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6692|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.6|0.6692
91653393|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6737|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.6|0.6737
91653394|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3888|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.3888
91653395|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.92|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.6|-0.5|0.9200
91609365|NCT02495077|183112367|SUPERIORITY|||||||0.347|||||||Chi-squared|||||||0.347
91609366|NCT02839746|183112376|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 2.||||<0.0001
91609367|NCT02839746|183112376|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline satisfaction with that of Visit 2.||||<0.0001
91609368|NCT02839746|183112377|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 3.||||<0.0001
91609369|NCT02839746|183112377|OTHER|Within group comparison of Baseline satisfaction with that of Visit 3.|||||<|0.0001|||||||non-parametric Wilcoxon signed-rank]|||||||<0.0001
91609370|NCT02839746|183112378|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 convenience with that of Visit 3.||||<0.0001
91609371|NCT02839746|183112378|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 satisfaction with that of Visit 3.||||<0.0001
91609372|NCT02333331|183112395|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.274|TWO_SIDED|95.0|-0.64|1.21|||Mixed Models Analysis|||||1.21|-0.64|0.274
91609373|NCT02333331|183112395|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.32|TWO_SIDED|95.0|-0.83|1.35|||Mixed Models Analysis|||||1.35|-0.83|0.320
91609374|NCT02333331|183112395|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.134|TWO_SIDED|95.0|-0.24|0.87|||Mixed Models Analysis|||||0.87|-0.24|0.134
91609375|NCT02333331|183112396|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.576|TWO_SIDED|95.0|-37.6|30.95|||Mixed Models Analysis|||||30.95|-37.6|0.576
91609376|NCT02333331|183112396|SUPERIORITY||Mean Difference (Final Values)|19.6||||0.178|TWO_SIDED|95.0|-22.2|61.41|||Mixed Models Analysis|||||61.41|-22.2|0.178
91609377|NCT02333331|183112396|SUPERIORITY||Mean Difference (Final Values)|10.31||||0.163|TWO_SIDED|95.0|-10.4|30.98|||Mixed Models Analysis|||||30.98|-10.4|0.163
91609378|NCT02333331|183112397|SUPERIORITY||Mean Difference (Net)|0.0||||0.488|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.10|-0.10|0.488
91609379|NCT02333331|183112397|SUPERIORITY||Mean Difference (Net)|0.1||||0.055|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||||0.22|-0.02|0.055
91609380|NCT02333331|183112397|SUPERIORITY||Mean Difference (Net)|0.03||||0.161|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.09|-0.03|0.161
91609381|NCT02333331|183112398|SUPERIORITY||Mean Difference (Net)|1.01||||0.213|TWO_SIDED|95.0|0.99|1.03|||Mixed Models Analysis|||||1.03|0.99|0.213
91609382|NCT02333331|183112398|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.09|||Mixed Models Analysis|||||1.09|1.03|<0.001
91609383|NCT02333331|183112398|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.05|1.08|||Mixed Models Analysis|||||1.08|1.05|<0.001
91609384|NCT02333331|183112399|SUPERIORITY||Mean Difference (Net)|1.0||||0.458|TWO_SIDED|95.0|0.98|1.02|||Mixed Models Analysis|||||1.02|0.98|0.458
91523560|NCT00279201|182923046|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||0.005
91523561|NCT00279201|182923047|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.002
91609385|NCT02333331|183112399|SUPERIORITY||Mean Difference (Net)|1.05|||<|0.001|TWO_SIDED|95.0|1.03|1.08|||Mixed Models Analysis|||||1.08|1.03|<0.001
91609386|NCT02333331|183112399|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.04|1.07|||Mixed Models Analysis|||||1.07|1.04|<0.001
91609387|NCT03952546|183112403|NON_INFERIORITY|The test for non-inferiority was carried out by calculating the upper 95% confidence limit (one sided confidence interval) for the difference in estimated blood loss (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer), with the margin of inferiority (δ), set at 200 cc.||||||0.1254|||||||t-test, 1 sided|||||||0.1254
91609388|NCT03952546|183112404|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91609389|NCT00685178|183112410|SUPERIORITY||F-value for main effect of Condition|2.21||||0.531|TWO_SIDED|||||Using the proportion of negative urine samples obtained, the four groups were compared to determine whether there are any group differences in cocaine abstinence (as measured by negative urine samples).|Chi-squared||F-value for main effect of Drug Condition|||||0.531
91609390|NCT00685178|183112411|SUPERIORITY||Spearmann's rank correlation|0.969|||<|0.001|TWO_SIDED||||||ANOVA||CR subjects only|Analyses were performed to measure the correlation between CR groups (topiramate + CR and Placebo + CR) and abstinence.||||<0.001
91609391|NCT00685178|183112411|SUPERIORITY||Spearmann's rank correlation|0.494|||<|0.001|TWO_SIDED||||||Generalized Estimating Equation (GEE)||NonCR subjects only|Analyses were performed to measure the correlation between Non-CR groups (topiramate + NonCR and Placebo + NonCR) and abstinence.||||<0.001
91609392|NCT05299892|183112445|OTHER||Mean Difference (Final Values)|6.46153||||0.005|TWO_SIDED|95.0|1.79|12.99|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.||12.99|1.79|.005
91609393|NCT05299892|183112445|OTHER||Mean Difference (Final Values)|9.00961|||<|0.001|TWO_SIDED|95.0|3.91|15.11|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.||15.11|3.91|<.001
91609394|NCT05299892|183112445|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.||||<0.001
91609395|NCT00149214|183112447|SUPERIORITY_OR_OTHER||Percentage of Participants|16.5||||||95.0|10.5|24.2||||||Confidence Interval for pathological complete response in the Pemetrexed treatment arm.||24.2|10.5|
91788524|NCT03073733|183457621|SUPERIORITY||least squares mean difference|-0.3542|STANDARD_ERROR_OF_MEAN|0.7793||0.759|TWO_SIDED|95.0|-2.6516|1.9433|||linear model for repeated measures|||||1.9433|-2.6516|0.759
91609396|NCT00149214|183112447|SUPERIORITY_OR_OTHER||Percentage of Participants|20.2||||||95.0|13.4|28.5||||||Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.||28.5|13.4|
91609397|NCT00756002|183112454|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||<0.001
91609398|NCT00756002|183112455|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609399|NCT00756002|183112456|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609400|NCT00756002|183112457|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||0.003
91609401|NCT00756002|183112458|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609402|NCT00756002|183112459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91653396|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7061|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.4|0.7061
91653397|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3337|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.3|0.3337
91609403|NCT00756002|183112460|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609404|NCT00756002|183112461|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609405|NCT00756002|183112462|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91653398|NCT02146430|183199613|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2139|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|-0.2|0.2139
91653399|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|2.197|STANDARD_ERROR_OF_MEAN|1.4933||0.1416|TWO_SIDED|95.0|-0.733|5.126|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||5.126|-0.733|0.1416
91788525|NCT03073733|183457622|SUPERIORITY||least squares mean difference|-278.73|STANDARD_ERROR_OF_MEAN|305.192||0.515|TWO_SIDED|95.0|-1126.21|568.75|||linear model for repeated measures|||||568.75|-1126.21|0.515
91788526|NCT03073733|183457622|SUPERIORITY||least squares mean difference|292.18|STANDARD_ERROR_OF_MEAN|308.659||0.499|TWO_SIDED|95.0|-562.87|1147.23|||linear model for repeated measures|||||1147.23|-562.87|0.499
91788527|NCT03073733|183457623|SUPERIORITY||least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.16|TWO_SIDED|95.0|-2.1|0.3|||linear model for repeated measures|||||0.3|-2.1|0.160
91788528|NCT03073733|183457623|SUPERIORITY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.622|TWO_SIDED|95.0|-1.5|0.9|||linear model for repeated measures|||||0.9|-1.5|0.622
91788529|NCT03073733|183457624|SUPERIORITY||least squares mean difference|-0.111|STANDARD_ERROR_OF_MEAN|0.1038||0.442|TWO_SIDED|95.0|-0.399|0.176|||linear model for repeated measures|||||0.176|-0.399|0.442
91788530|NCT03073733|183457624|SUPERIORITY||least squares mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.1037||0.401|TWO_SIDED|95.0|-0.165|0.409|||linear model for repeated measures|||||0.409|-0.165|0.401
91788531|NCT03073733|183457626|SUPERIORITY|||||||0.205|||||||Fisher Exact|||||||0.205
91788532|NCT03073733|183457627|SUPERIORITY|||||||0.157|||||||Fisher Exact|||||||0.157
91788533|NCT03073733|183457628|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
91788534|NCT03073733|183457629|SUPERIORITY|||||||0.173|||||||Fisher Exact|||||||0.173
91788535|NCT03073733|183457630|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.2)||||||0.099
91788536|NCT03073733|183457630|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9)||||||0.130
91788537|NCT03073733|183457631|SUPERIORITY|||||||0.0959|||||||Fisher Exact|||||||0.0959
91788538|NCT03073733|183457632|SUPERIORITY|||||||0.1868|||||||Fisher Exact|||||||0.1868
91788539|NCT03073733|183457633|SUPERIORITY|||||||0.608|||||||Fisher Exact|||||||0.608
91788540|NCT03073733|183457634|SUPERIORITY|||||||0.264|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.264
91788541|NCT03073733|183457634|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.9)||||||0.139
91788542|NCT03073733|183457635|SUPERIORITY|||||||0.261|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.261
91788543|NCT03073733|183457635|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.3)||||||0.139
91609406|NCT00756002|183112463|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609407|NCT00756002|183112464|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609408|NCT00756002|183112465|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609409|NCT00756002|183112466|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||<0.001
91609410|NCT00756002|183112467|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||0.043
91609411|NCT00756002|183112468|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
91609412|NCT00756002|183112469|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.010
91609413|NCT00756002|183112470|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.002
91609414|NCT00756002|183112471|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.006
91609415|NCT00756002|183112472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
91609416|NCT00756002|183112473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
91609417|NCT00756002|183112474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
91609418|NCT00756002|183112475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609419|NCT00756002|183112476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609420|NCT00756002|183112477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91653400|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|0.249|STANDARD_ERROR_OF_MEAN|1.492||0.8677|TWO_SIDED|95.0|-2.679|3.176|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.176|-2.679|0.8677
91609421|NCT00756002|183112478|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609422|NCT00756002|183112479|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91653401|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-0.899|STANDARD_ERROR_OF_MEAN|1.4959||0.5481|TWO_SIDED|95.0|-3.834|2.036|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||2.036|-3.834|0.5481
91653402|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-1.948|STANDARD_ERROR_OF_MEAN|1.4875||0.1906|TWO_SIDED|95.0|-4.866|0.971|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.971|-4.866|0.1906
91653403|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-3.095|STANDARD_ERROR_OF_MEAN|1.4883||0.0378|TWO_SIDED|95.0|-6.015|-0.175|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||-0.175|-6.015|0.0378
91788544|NCT03073733|183457636|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.8).||||||0.350
91788545|NCT03073733|183457636|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.500
91788546|NCT03073733|183457637|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.9).||||||0.220
91609423|NCT00756002|183112480|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
91609424|NCT00756002|183112481|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.785
91609425|NCT00756002|183112482|SUPERIORITY_OR_OTHER|||||||0.422||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.422
91653404|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|0.664|STANDARD_ERROR_OF_MEAN|0.6865||0.3337|TWO_SIDED|95.0|-0.683|2.011|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.011|-0.683|0.3337
91653405|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-0.194|STANDARD_ERROR_OF_MEAN|0.686||0.7778|TWO_SIDED|95.0|-1.54|1.152|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.152|-1.540|0.7778
91653406|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-0.087|STANDARD_ERROR_OF_MEAN|0.6879||0.8991|TWO_SIDED|95.0|-1.437|1.262|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.262|-1.437|0.8991
91653407|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-0.857|STANDARD_ERROR_OF_MEAN|0.6833||0.2098|TWO_SIDED|95.0|-2.198|0.483|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.483|-2.198|0.2098
91788547|NCT03073733|183457637|SUPERIORITY|||||||0.119|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9).||||||0.119
91788548|NCT03073733|183457638|SUPERIORITY|||||||0.006|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.7)||||||0.006
91788549|NCT03073733|183457639|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
91788550|NCT03073733|183457640|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
91788551|NCT03073733|183457641|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.010
91788552|NCT03073733|183457642|SUPERIORITY|||||||0.072|||||||Fisher Exact|||||||0.072
91788553|NCT03073733|183457643|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.9)||||||0.019
91788554|NCT03073733|183457643|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.019
91653408|NCT02146430|183199614|SUPERIORITY||Difference in least squares means|-0.751|STANDARD_ERROR_OF_MEAN|0.6842||0.2725|TWO_SIDED|95.0|-2.093|0.591|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.591|-2.093|0.2725
91653409|NCT02146430|183199615|SUPERIORITY||Difference in least squares means|0.0018|STANDARD_ERROR_OF_MEAN|0.01329||0.8923|TWO_SIDED|95.0|-0.0243|0.0279|||ANCOVA|||||0.0279|-0.0243|0.8923
91653410|NCT02146430|183199615|SUPERIORITY||Difference in least squares means|-0.0021|STANDARD_ERROR_OF_MEAN|0.01327||0.8749|TWO_SIDED|95.0|-0.0281|0.024|||ANCOVA|||||0.0240|-0.0281|0.8749
91653411|NCT02146430|183199615|SUPERIORITY||Difference in least squares means|-0.0091|STANDARD_ERROR_OF_MEAN|0.01332||0.4932|TWO_SIDED|95.0|-0.0353|0.017|||ANCOVA|||||0.0170|-0.0353|0.4932
91653412|NCT02146430|183199615|SUPERIORITY||Difference in least squares means|-0.0039|STANDARD_ERROR_OF_MEAN|0.01323||0.7688|TWO_SIDED|95.0|-0.0298|0.0221|||ANCOVA|||||0.0221|-0.0298|0.7688
91653413|NCT02146430|183199615|SUPERIORITY||Difference in least squares means|-0.0109|STANDARD_ERROR_OF_MEAN|0.01326||0.4099|TWO_SIDED|95.0|-0.0369|0.0151|||ANCOVA|||||0.0151|-0.0369|0.4099
91653414|NCT02146430|183199616|SUPERIORITY||Difference in least squares means|-0.55|STANDARD_ERROR_OF_MEAN|0.166||0.0009|TWO_SIDED|95.0|-0.88|-0.23|||Mixed Models Analysis|||||-0.23|-0.88|0.0009
91653415|NCT02146430|183199616|SUPERIORITY||Difference in least squares means|-0.63|STANDARD_ERROR_OF_MEAN|0.166||0.0001|TWO_SIDED|95.0|-0.96|-0.31|||Mixed Models Analysis|||||-0.31|-0.96|0.0001
91653416|NCT02146430|183199616|SUPERIORITY||Difference in least squares means|-0.85|STANDARD_ERROR_OF_MEAN|0.167|<|0.0001|TWO_SIDED|95.0|-1.17|-0.52|||Mixed Models Analysis|||||-0.52|-1.17|<0.0001
91653417|NCT02146430|183199616|SUPERIORITY||Difference in least squares means|-0.08|STANDARD_ERROR_OF_MEAN|0.167||0.6408|TWO_SIDED|95.0|-0.4|0.25|||Mixed Models Analysis|||||0.25|-0.40|0.6408
91788555|NCT03073733|183457644|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
91653418|NCT02146430|183199616|SUPERIORITY||Difference in least squares means|-0.29|STANDARD_ERROR_OF_MEAN|0.167||0.0786|TWO_SIDED|95.0|-0.62|0.03|||Mixed Models Analysis|||||0.03|-0.62|0.0786
91653419|NCT02146430|183199618|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0541|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.7|0.0541
91653420|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.7771|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.3|-0.4|0.7771
91653421|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.5488|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5488
91788556|NCT03073733|183457645|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
91788557|NCT03073733|183457646|SUPERIORITY|||||||0.199|||||||Fisher Exact|||||||0.199
91788558|NCT03073733|183457647|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 56.3)||||||0.075
91653422|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0987|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0987
91653423|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.184|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1840
91653424|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1903|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||0.1|-0.6|0.1903
91653425|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5787|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.4|0.5787
91653426|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5535|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.5535
91653427|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4476|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.2|0.4476
91653428|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4737|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.4737
91653429|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0814|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.6|0.0814
91653430|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.3069|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3069
91653431|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3916|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.3916
91653432|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4667|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.2|0.4667
91653433|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3744|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3744
91788559|NCT03073733|183457647|SUPERIORITY|||||||0.062|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.2)||||||0.062
91788560|NCT03073733|183457648|SUPERIORITY|||||||0.255|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.9)||||||0.255
91788561|NCT03073733|183457648|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.7)||||||0.109
91788562|NCT03073733|183457649|SUPERIORITY|||||||0.488|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.7).||||||0.488
91788563|NCT03073733|183457649|SUPERIORITY|||||||0.273|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.273
91788564|NCT03073733|183457650|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
91788565|NCT03073733|183457651|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
91788566|NCT03073733|183457652|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
91788567|NCT03073733|183457653|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
91788568|NCT03073733|183457654|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.2)||||||0.019
91788569|NCT03073733|183457654|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.7)||||||0.011
91788570|NCT03073733|183457655|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
91653434|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2959|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||0.2|-0.6|0.2959
91653435|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9119|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9119
91653436|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9399|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.9399
91653437|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2455|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.2455
91653438|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3311|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3311
91653439|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.254|STANDARD_ERROR_OF_MEAN|0.1647||0.1233|TWO_SIDED|95.0|-0.577|0.069|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||0.069|-0.577|0.1233
91653440|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.072|STANDARD_ERROR_OF_MEAN|0.1643||0.661|TWO_SIDED|95.0|-0.394|0.25|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.250|-0.394|0.6610
91653441|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.098|STANDARD_ERROR_OF_MEAN|0.1649||0.5514|TWO_SIDED|95.0|-0.422|0.225|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.225|-0.422|0.5514
91788571|NCT03073733|183457656|SUPERIORITY|||||||0.096|||||||Fisher Exact|||||||0.096
91653442|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.182|STANDARD_ERROR_OF_MEAN|0.1638||0.2673|TWO_SIDED|95.0|-0.14|0.503|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.503|-0.140|0.2673
91653443|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.156|STANDARD_ERROR_OF_MEAN|0.1644||0.3439|TWO_SIDED|95.0|-0.167|0.478|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.478|-0.167|0.3439
91653444|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|2.6|STANDARD_ERROR_OF_MEAN|2.4||0.2708|TWO_SIDED|95.0|-2.1|7.4|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||7.4|-2.1|0.2708
91653445|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|1.2|STANDARD_ERROR_OF_MEAN|2.4||0.6285|TWO_SIDED|95.0|-3.5|5.9|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||5.9|-3.5|0.6285
91653446|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|2.41||0.9177|TWO_SIDED|95.0|-5.0|4.5|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 150 mg BID||4.5|-5.0|0.9177
91653447|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-1.5|STANDARD_ERROR_OF_MEAN|2.38||0.5334|TWO_SIDED|95.0|-6.2|3.2|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.2|-6.2|0.5334
91653448|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-2.9|STANDARD_ERROR_OF_MEAN|2.39||0.2261|TWO_SIDED|95.0|-7.6|1.8|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.8|-7.6|0.2261
91653449|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-3.87|STANDARD_ERROR_OF_MEAN|1.758||0.0281|TWO_SIDED|95.0|-7.32|-0.42|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-0.42|-7.32|0.0281
91653450|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-1.42|STANDARD_ERROR_OF_MEAN|1.756||0.419|TWO_SIDED|95.0|-4.87|2.03|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||2.03|-4.87|0.4190
91653451|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-1.61|STANDARD_ERROR_OF_MEAN|1.763||0.3622|TWO_SIDED|95.0|-5.06|1.85|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.85|-5.06|0.3622
91653452|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|2.45|STANDARD_ERROR_OF_MEAN|1.75||0.1623|TWO_SIDED|95.0|-0.99|5.88|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.88|-0.99|0.1623
91653453|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|2.26|STANDARD_ERROR_OF_MEAN|1.753||0.1978|TWO_SIDED|95.0|-1.18|5.7|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.70|-1.18|0.1978
91788572|NCT03073733|183457657|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.480
91788573|NCT03073733|183457658|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 51.5)||||||0.076
91788574|NCT03073733|183457658|SUPERIORITY|||||||0.057|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 26.1)||||||0.057
91788575|NCT03073733|183457659|SUPERIORITY|||||||0.117|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 29.0)||||||0.117
91788576|NCT03073733|183457659|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.5)||||||0.083
91788577|NCT03073733|183457660|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.7)||||||0.172
91788578|NCT03073733|183457660|SUPERIORITY|||||||0.14|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.140
91788579|NCT03073733|183457661|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.4).||||||0.011
91788580|NCT03073733|183457662|SUPERIORITY|||||||0.0406|||||||Fisher Exact|||||||0.0406
91788581|NCT03073733|183457663|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
91788582|NCT03073733|183457664|SUPERIORITY|||||||0.026|||||||Fisher Exact|||||||0.026
91788583|NCT03073733|183457665|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
91788584|NCT03073733|183457666|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 22.2)||||||0.030
91788585|NCT03073733|183457666|SUPERIORITY|||||||0.033|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.3)||||||0.033
91788586|NCT03073733|183457667|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
91788587|NCT03073733|183457668|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
91788588|NCT03073733|183457669|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91788589|NCT03073733|183457670|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 606.4)||||||0.080
91788590|NCT03073733|183457670|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 52.3)||||||0.050
91788591|NCT03073733|183457671|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 35.7)||||||0.099
91788592|NCT03073733|183457671|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 17.6)||||||0.076
91609426|NCT00756002|183112483|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.665
91653454|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0867|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||0.1|-0.8|0.0867
91609427|NCT00756002|183112484|SUPERIORITY_OR_OTHER|||||||0.228||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.228
91609428|NCT00756002|183112485|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.099
91609429|NCT00756002|183112486|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
91788593|NCT03073733|183457672|SUPERIORITY|||||||0.1099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.5)||||||0.1099
91788594|NCT03073733|183457672|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 14.3)||||||0.012
91788595|NCT01227629|183457689|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to last available value||||0.0357
91609430|NCT00756002|183112487|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
91653455|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6993
91653456|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8702|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8702
91653457|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1826|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.1826
91788596|NCT01227629|183457690|SUPERIORITY_OR_OTHER|||||||0.26711||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to week 12||||0.26711
91788597|NCT01588470|183457700|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91788598|NCT01588470|183457702|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91788599|NCT02446171|183457720|SUPERIORITY_OR_OTHER||Ratio#|98.89|||||TWO_SIDED|90.0|92.4|105.84|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.84|92.40|
91788600|NCT02446171|183457720|SUPERIORITY_OR_OTHER||Ratio#|100.04|||||TWO_SIDED|90.0|93.17|107.43|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.43|93.17|
91788601|NCT02446171|183457720|SUPERIORITY_OR_OTHER||Ratio#|94.37|||||TWO_SIDED|90.0|88.7|100.4|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.40|88.70|
91788602|NCT02446171|183457721|SUPERIORITY_OR_OTHER||Ratio#|98.79|||||TWO_SIDED|90.0|92.24|105.8|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.80|92.24|
91788603|NCT02446171|183457721|SUPERIORITY_OR_OTHER||Ratio#|100.44|||||TWO_SIDED|90.0|93.65|107.72|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.72|93.65|
91788604|NCT02446171|183457721|SUPERIORITY_OR_OTHER||Ratio#|94.83|||||TWO_SIDED|90.0|89.2|100.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.82|89.20|
91788605|NCT02446171|183457722|SUPERIORITY_OR_OTHER||Ratio#|97.05|||||TWO_SIDED|90.0|88.09|106.92|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||106.92|88.09|
91788606|NCT02446171|183457722|SUPERIORITY_OR_OTHER||Ratio#|100.56|||||TWO_SIDED|90.0|91.8|110.16|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||110.16|91.80|
91788607|NCT02446171|183457722|SUPERIORITY_OR_OTHER||Ratio#|102.5|||||TWO_SIDED|90.0|93.13|111.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||111.82|93.13|
91788608|NCT02320903|183457751|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was 0.16.|||
91788609|NCT02320903|183457751|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.22.|||
91788610|NCT02320903|183457752|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
91788611|NCT02320903|183457752|OTHER|What was the within-group change over time effect size?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for teen report on this measure was d = 0.22.|||
91788612|NCT02320903|183457753|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.10.|||
91609431|NCT00756002|183112488|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.001
91609432|NCT00756002|183112489|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
91609433|NCT00756002|183112490|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.040
91609434|NCT00756002|183112491|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.814
91609435|NCT00756002|183112492|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.929
91609436|NCT00756002|183112493|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.591
91609437|NCT00756002|183112494|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.015
91609438|NCT00756002|183112495|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.097
91609439|NCT00756002|183112496|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.028
91609440|NCT00756002|183112497|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.003
91609441|NCT00756002|183112498|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.111
91609442|NCT04329923|183112507|SUPERIORITY||Cox Proportional Hazard|0.58||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
91613280|NCT01254604|183121041|SUPERIORITY_OR_OTHER||Difference in percentage|19.5|||||TWO_SIDED|95.0|5.7|33.4|||Stratified Miettinen and Nurminen method|Participants were stratified by baseline IOP (\<26 mmHg or ≥26 mmHg at 0800 hours) and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) - percentage (timolol)|||33.4|5.7|
91613281|NCT01254604|183121042|SUPERIORITY_OR_OTHER||Difference in percentage|-3.9|||||TWO_SIDED|95.0|-17.3|9.4|||Miettinen and Nurminen||Between-group difference in percentage of participants with an AE = percentage (tafluprost) - percentage (timolol)|||9.4|-17.3|
91788613|NCT02320903|183457753|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired samples T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.28.|||
91788614|NCT02320903|183457754|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.16.|||
91788615|NCT02320903|183457754|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report was d = 0.21.|||
91788616|NCT02320903|183457755|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.62.|||
91788617|NCT02320903|183457755|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.23.|||
91788618|NCT02320903|183457756|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
91788619|NCT02320903|183457756|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired samples T tests were used to measure within-groups change over time for teens.|Cohen's d for youth report was d = 0.26.|||
91788620|NCT02320903|183457757|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d =.12.|||
91788621|NCT02320903|183457758|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.81.|||
91788622|NCT02320903|183457759|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.43.|||
91788623|NCT02320903|183457760|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report on this measure was d = 24.|||
91788624|NCT03386253|183457776|SUPERIORITY|||||||0.77||||||Group x time p value|ANOVA|||||||0.77
91788625|NCT01012219|183457777|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||||1.56|0.96|
91788626|NCT03493815|183457778|SUPERIORITY||Risk Ratio (RR)|0.73||||0.51|TWO_SIDED|95.0|0.28|1.9|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||1.90|0.28|0.51
91788627|NCT03493815|183457779|SUPERIORITY||Risk Ratio (RR)|0.58||||0.41|TWO_SIDED|95.0|0.15|2.18|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||2.18|0.15|0.41
91788628|NCT03493815|183457780|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
91788629|NCT03493815|183457781|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
91788630|NCT03811093|183457782|SUPERIORITY||Mean Difference (Net)|2.036|||<|0.01|TWO_SIDED|95.0|1.243|2.828||p-value is calculated using SPSS.|t-test, 2 sided|||The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.||2.828|1.243|<0.01
91788631|NCT03811093|183457782|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218."||||0.20
91788632|NCT03811093|183457782|OTHER|||||||0.075|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.075
91788633|NCT03811093|183457783|SUPERIORITY||Mean Difference (Net)|7.063|||<|0.01|TWO_SIDED|95.0|3.829|10.296||p-value is calculated using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.||10.296|3.829|<0.01
91788634|NCT03811093|183457783|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796."||||0.20
91788635|NCT03811093|183457783|OTHER|||||||0.44|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.44
91791079|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.422||0.954|TWO_SIDED|95.0|-0.854|0.806||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.806|-0.854|0.954
91791080|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91791081|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.412||0.649|TWO_SIDED|95.0|-0.622|0.997||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.997|-0.622|0.649
91791082|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|2.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91791083|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.423||0.358|TWO_SIDED|95.0|-1.22|0.443||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.443|-1.220|0.358
91609443|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|16.0|||||TWO_SIDED|95.0|5.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||29|5|
91609444|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|32.0|||||TWO_SIDED|95.0|21.0|44.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||44|21|
91609445|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|15.0|||||TWO_SIDED|95.0|0.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||30|0|
91613282|NCT01254604|183121043|SUPERIORITY_OR_OTHER||Difference in percentage|1.1|||||TWO_SIDED|95.0|-3.5|5.7|||Miettinen and Nurminen||Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) - percentage (timolol)|||5.7|-3.5|
91613283|NCT03074162|183121044|EQUIVALENCE|The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|45.54|STANDARD_ERROR_OF_MEAN|35.99|||TWO_SIDED|90.0|40.11|51.7|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||51.70|40.11|
91613284|NCT03074162|183121044|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|85.56|STANDARD_ERROR_OF_MEAN|42.05|||TWO_SIDED|90.0|74.11|98.77|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||98.77|74.11|
91613285|NCT03074162|183121045|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|49.6|STANDARD_ERROR_OF_MEAN|38.13|||TWO_SIDED|90.0|43.39|56.71|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||56.71|43.39|
91613286|NCT03074162|183121045|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|83.57|STANDARD_ERROR_OF_MEAN|72.45|||TWO_SIDED|90.0|66.33|105.31|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||105.31|66.33|
91613287|NCT01958671|183121049|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||<|0.001|TWO_SIDED|95.0|-1.22|-0.76|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.76|-1.22|<0.001
91613288|NCT01958671|183121049|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.39|-0.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.93|-1.39|<0.001
91613289|NCT01958671|183121050|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.1|8.1|||||Based on Miettinen \& Nurminen method.|||8.1|-13.1|
91613290|NCT01958671|183121050|SUPERIORITY_OR_OTHER||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-14.8|6.6|||||Based on Miettinen \& Nurminen method.|||6.6|-14.8|
91613291|NCT01958671|183121051|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-7.7|3.3|||||Based on Miettinen \& Nurminen method.|||3.3|-7.7|
91613292|NCT01958671|183121051|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-8.2|2.7|||||Based on Miettinen \& Nurminen method.|||2.7|-8.2|
91613293|NCT01958671|183121052|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.53|||<|0.001|TWO_SIDED|95.0|-42.76|-26.29|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-26.29|-42.76|<0.001
91653458|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1206|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1206
91653459|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0211|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0211
91653460|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.4963|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.3|-0.6|0.4963
91653461|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3031|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.6|0.3031
91653462|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1019|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1019
91653463|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.201|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.2010
91653464|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0331|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||-0.0|-0.9|0.0331
91653465|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7478|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.7478
91791084|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91653466|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.694|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6940
91653467|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.069|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.0|0.0690
91653468|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0816|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0816
91653469|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1174|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.1|-0.7|0.1174
91653470|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.925|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9250
91653471|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8555|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8555
91653472|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0956|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0956
91653473|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1659|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1659
91791085|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.539||0.859|TWO_SIDED|95.0|-1.155|0.963||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.963|-1.155|0.859
91791086|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|3.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791087|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.529||0.455|TWO_SIDED|95.0|-0.644|1.437||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.437|-0.644|0.455
91791088|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|3.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791089|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.538||0.335|TWO_SIDED|95.0|-1.578|0.539||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.539|-1.578|0.335
91791090|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791091|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.681||0.875|TWO_SIDED|95.0|-1.447|1.233||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.233|-1.447|0.875
91791092|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791093|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.668||0.712|TWO_SIDED|95.0|-1.068|1.561||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.561|-1.068|0.712
91791094|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|4.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91653474|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0468|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0468
91653475|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1083|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1083
91653476|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0505|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.0|-0.8|0.0505
91653477|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.6993
91653478|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9781|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.4|0.9781
91653479|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.0154|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.1|-1.0|0.0154
91653480|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0731|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||0.0|-0.9|0.0731
91653481|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0259|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.1|-1.0|0.0259
91788636|NCT03811093|183457784|SUPERIORITY||Mean Difference (Net)|4.4703|||<|0.01|TWO_SIDED|95.0|2.3372|6.6034||p-value is computed using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.||6.6034|2.3372|<0.01
91653482|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5243|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5243
91653483|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.8488|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.4|0.8488
91653484|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2746|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2746
91653485|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9349|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9349
91653486|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.5164|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.6|-0.3|0.5164
91653487|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.2382|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.2|0.2382
91653488|NCT02146430|183199618|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0807|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0807
91653489|NCT02146430|183199619|SUPERIORITY||Difference in least squares means|-0.045|STANDARD_ERROR_OF_MEAN|0.0237||0.0601|TWO_SIDED|95.0|-0.091|0.002|||ANCOVA|||||0.002|-0.091|0.0601
91653490|NCT02146430|183199619|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8299|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8299
91653491|NCT02146430|183199619|SUPERIORITY||Difference in least squares means|-0.05|STANDARD_ERROR_OF_MEAN|0.0237||0.0347|TWO_SIDED|95.0|-0.096|0.004|||ANCOVA|||||0.004|-0.096|0.0347
91523562|NCT00279201|182923047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for \<7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||<0.001
91653492|NCT02146430|183199619|SUPERIORITY||Difference in least squares means|0.04|STANDARD_ERROR_OF_MEAN|0.0237||0.0951|TWO_SIDED|95.0|-0.007|0.086|||ANCOVA|||||0.086|-0.007|0.0951
91653493|NCT02146430|183199619|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8199|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8199
91653494|NCT03093324|183199620|SUPERIORITY||Rate ratio|0.542||||0.0003|TWO_SIDED|95.0|0.39|0.754|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.754|0.390|0.0003
91653495|NCT03093324|183199621|SUPERIORITY||Rate ratio|0.52||||0.0007|TWO_SIDED|95.0|0.356|0.76|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.760|0.356|0.0007
91609446|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|18.0|||||TWO_SIDED|95.0|5.0|31.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||31|5|
91609447|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|18.0|||||TWO_SIDED|95.0|7.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||30|7|
91609448|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|30.0|||||TWO_SIDED|95.0|18.0|42.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||42|18|
91609449|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|19.0|||||TWO_SIDED|95.0|4.0|33.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||33|4|
91609450|NCT01272180|183112512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.|Group Difference % (ABCWY+qOMV - ACWY)|15.0|||||TWO_SIDED|95.0|3.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||29|3|
91609451|NCT03334214|183112523|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
91653496|NCT03093324|183199622|SUPERIORITY||Rate ratio|0.714||||0.009|TWO_SIDED|95.0|0.554|0.921|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.921|0.554|0.009
91653497|NCT03093324|183199623|SUPERIORITY||Rate ratio|0.555||||0.009|TWO_SIDED|95.0|0.357|0.862|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.862|0.357|0.009
91609452|NCT03334214|183112524|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
91609453|NCT03334214|183112527|SUPERIORITY|||||||0.024|||||||ANOVA|||||||0.024
91609454|NCT03334214|183112528|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|The p-value is obtained using Cochran-Mantel-Haenszel (CMH) test stratified by the baseline liver fat stratum (\<20%, ≥20%) stratification factor.||||||0.0774
91609455|NCT03334214|183112529|SUPERIORITY|||||||0.183|||||||ANOVA|||||||0.183
91609456|NCT03334214|183112530|SUPERIORITY|||||||0.682|||||||ANOVA|||Total Cholesterol||||0.682
91609457|NCT03334214|183112530|SUPERIORITY|||||||0.716|||||||ANOVA|||ApoB||||0.716
91523563|NCT00279201|182923047|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.174
91523564|NCT00279201|182923048|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.416
91609458|NCT03334214|183112530|SUPERIORITY|||||||0.717|||||||ANOVA|||HDL||||0.717
91609459|NCT03334214|183112530|SUPERIORITY|||||||0.463|||||||ANOVA|||LDL-C||||0.463
91609460|NCT03334214|183112530|SUPERIORITY|||||||0.555|||||||ANOVA|||Non-HDL||||0.555
91788637|NCT03811093|183457784|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209."||||.200
91788638|NCT03811093|183457784|OTHER|||||||0.438|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||.438
91788639|NCT00178503|183457785|SUPERIORITY_OR_OTHER||Linear trend P value|0.0|||=|0.001|||||||ANOVA|||Data were analyzed using SPSS-PC repeated measures one-way analysis of variance (ANOVA), with MPH dosing regimen as the within-subjects variable.||||=.001
91788640|NCT00178503|183457786|SUPERIORITY_OR_OTHER||Linear p|0.005||||0.005|||||||ANOVA|||||||.005
91788641|NCT00178503|183457787|SUPERIORITY_OR_OTHER||Linear p|0.0|||<|0.001||0.0|||||ANOVA|||||||<.001
91788642|NCT00464490|183457789|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value \<0.05 was considered significant|t-test, 2 sided|||H(0): Ventilator time (DG) = Ventilator time (CG)||||0.02
91523565|NCT00279201|182923048|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91609461|NCT03334214|183112530|SUPERIORITY|||||||0.619|||||||ANOVA|||Triglycerides||||0.619
91609462|NCT03334214|183112530|SUPERIORITY|||||||0.698|||||||ANOVA|||VLDL-C||||0.698
91609463|NCT03334214|183112531|SUPERIORITY|||||||0.902|||||||ANOVA|||FPG||||0.902
91609464|NCT03334214|183112531|SUPERIORITY|||||||0.267|||||||Van Elteren test|||HOMA-IR||||0.267
91609465|NCT03334214|183112531|SUPERIORITY|||||||0.2|||||||Van Elteren test|||Insulin||||0.200
91609466|NCT03334214|183112532|SUPERIORITY|||||||0.933|||||||ANOVA|||||||0.933
91609467|NCT01702805|183112565|SUPERIORITY||Risk Ratio (RR)|1.0||||0.93|TWO_SIDED|95.0|0.92|1.1|||Robust Poisson Regression|The relative risk was adjusted for birth-weight and center stratum.||Null hypothesis: A higher hemoglobin threshold for red-cell transfusions, as compared with a lower threshold, will not reduce nor increase the incidence of death or neurodevelopmental impairment in infants at 22 to 26 months of age corrected for prematurity.||1.10|0.92|0.93
91609468|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
91609469|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
91609470|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.61|0.44|
91788643|NCT03739242|183457851|SUPERIORITY||Least Square Mean difference|-39.16|||<|0.0001|TWO_SIDED|95.0|-48.57|-29.75|||ANCOVA|||||-29.75|-48.57|<0.0001
91788644|NCT03739242|183457852|SUPERIORITY||Least Square Mean difference|-41.24||||0.0001|TWO_SIDED|95.0|-51.73|-30.74|||ANCOVA|||||-30.74|-51.73|0.0001
91788645|NCT03739242|183457853|SUPERIORITY||Least Square Mean difference|0.09||||0.951|TWO_SIDED|95.0|-2.87|3.05|||ANCOVA|||||3.05|-2.87|0.9510
91788646|NCT03739242|183457854|SUPERIORITY||Least Square Mean difference|-41.7|||<|0.0001|TWO_SIDED|95.0|-51.58|-31.82|||ANCOVA|||||-31.82|-51.58|<0.0001
91788647|NCT03739242|183457855|SUPERIORITY||Least Square Mean difference|-7.0||||0.1924|TWO_SIDED|95.0|-17.59|3.59|||ANCOVA|||||3.59|-17.59|0.1924
91788648|NCT03739242|183457856|SUPERIORITY||Least Square Mean difference|-17.26|||<|0.0001|TWO_SIDED|95.0|-23.54|-10.98|||ANCOVA|||||-10.98|-23.54|<0.0001
91788649|NCT03739242|183457857|SUPERIORITY||Least Square Mean difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.62|||ANCOVA|||||-0.62|-1.19|<0.0001
91788650|NCT03739242|183457858|SUPERIORITY||Least Square Mean difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.05|-0.59|||ANCOVA|||||-0.59|-1.05|<0.0001
91788651|NCT03739242|183457859|SUPERIORITY||Least Square Mean difference|-3.47||||0.4535|TWO_SIDED|95.0|-12.64|5.7|||ANCOVA|||||5.7|-12.64|0.4535
91788652|NCT03739242|183457860|SUPERIORITY||Least Square Mean difference|0.74||||0.5594|TWO_SIDED|95.0|-1.76|3.24|||ANCOVA|||||3.24|-1.76|0.5594
91788653|NCT03739242|183457861|SUPERIORITY||Least Square Mean difference|-0.07||||0.9266|TWO_SIDED|95.0|-1.63|1.48|||ANCOVA|||||1.48|-1.63|0.9266
91788654|NCT03739242|183457862|SUPERIORITY||Least Square Mean difference|6.02||||0.2654|TWO_SIDED|95.0|-4.66|16.69|||ANCOVA|||||16.69|-4.66|0.2654
91788655|NCT03739242|183457863|SUPERIORITY||Least Square Mean difference|-5.95||||0.2595|TWO_SIDED|95.0|-16.37|4.47|||ANCOVA|||||4.47|-16.37|0.2595
91788656|NCT03739242|183457864|SUPERIORITY||Least Square Mean difference|0.003||||0.8476|TWO_SIDED|95.0|-0.039|0.032|||ANCOVA|||||0.032|-0.039|0.8476
91788657|NCT03739242|183457865|SUPERIORITY||Least Square Mean difference|-0.21||||0.1499|TWO_SIDED|95.0|-0.49|0.08|||ANCOVA|||||0.08|-0.49|0.1499
91788658|NCT03739242|183457866|SUPERIORITY||Least Square Mean difference|1.71||||0.7224|TWO_SIDED|95.0|-7.83|11.25|||ANCOVA|||||11.25|-7.83|0.7224
91788659|NCT01122394|183457867|SUPERIORITY_OR_OTHER|||||||0.29|||||||robust regression|controlling for provider clustering||Robust regressions were performed||||0.29
91788660|NCT01122394|183457868|SUPERIORITY_OR_OTHER|||||||0.25|||||||Regression, Logistic|This analysis includes participants in pre-action and action/maintenance||||||0.25
91788661|NCT01122394|183457869|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91788662|NCT01122394|183457870|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|||||||0.81
91653498|NCT03093324|183199624|SUPERIORITY||Rate ratio|0.696||||0.033|TWO_SIDED|95.0|0.499|0.972|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.972|0.499|0.033
91653499|NCT03093324|183199625|SUPERIORITY||Rate ratio|0.662||||0.068|TWO_SIDED|95.0|0.425|1.031|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.031|0.425|0.068
91653500|NCT03093324|183199626|SUPERIORITY||Rate ratio|0.713||||0.215|TWO_SIDED|95.0|0.417|1.217|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.217|0.417|0.215
91653501|NCT03093324|183199627|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.043|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.0|-0.6|0.043
91653502|NCT03093324|183199627|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.7|<0.001
91653503|NCT03093324|183199627|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.001|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.9|0.001
91653504|NCT03093324|183199627|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.403|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.4|0.403
91653505|NCT03093324|183199627|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.261|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.6|0.261
91653506|NCT01767597|183199629|SUPERIORITY_OR_OTHER|||||||0.5||||||No p-value adjustments for multiple comparisons were required. Significance was determined using a p-value \<0.05.|Chi-squared|||Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.||||0.5
91788663|NCT01122394|183457871|SUPERIORITY_OR_OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
91523566|NCT00279201|182923048|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.003
91653507|NCT04583579|183199651|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91653508|NCT02006706|183199653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.606|<|0.001|TWO_SIDED|95.0|1.73|4.22|||t-test, 2 sided||The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up|||4.22|1.73|<0.001
91653509|NCT02006706|183199654|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91653510|NCT02173704|183199677|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||TWO_SIDED|95.0|97.2|100.0|||Exact test of binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.||100|97.2|
91653511|NCT02173704|183199677|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%.|single binomial proportion|79.0|||||TWO_SIDED|95.0|71.4|85.8|||Exact test of binomial proportion|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.||85.8|71.4|
91653512|NCT02173704|183199679|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|95.7|99.98|||Exact test of binomial proportion|||Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%.||99.98|95.7|
91788664|NCT00039871|183457872|SUPERIORITY_OR_OTHER||Binomial Approximation|0.217||||||99.0|0.195|0.239||||||||0.239|0.195|
91788665|NCT00039871|183457873|SUPERIORITY_OR_OTHER||Binomial Approximation|0.563||||||95.0|0.529|0.596||||||||0.596|0.529|
91788666|NCT00039871|183457874|SUPERIORITY_OR_OTHER||Binomial Approximation|0.122||||||95.0|0.076|0.169||||||||0.169|0.076|
91788667|NCT02446743|183457875|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine Group Difference|77.0|||||TWO_SIDED|95.0|68.1|84.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||84.1|68.1|
91791095|NCT02880956|183460094|SUPERIORITY||LS Mean of Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.687||0.269|TWO_SIDED|95.0|-2.112|0.59||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.590|-2.112|0.269
91523567|NCT00279201|182923048|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
91653513|NCT02173704|183199679|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|94.7|99.82|||Exact test for binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.||99.82|94.7|
91653514|NCT02173704|183199679|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|94.0|||||TWO_SIDED|95.0|88.7|97.4|||Exact test for binomial proportions|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.||97.4|88.7|
91609471|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
91609472|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.24|0.18|
91609473|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.31|
91609474|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.32|0.19|
91609475|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
91609476|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.30|0.17|
91609477|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.39|0.25|
91609478|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.38|0.27|
91609479|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
91609480|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.20|0.10|
91653515|NCT03901963|183199688|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.37|8.57||Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'|stratified Cochran-Mantel-Haenszel (CMH)||Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.|||8.57|2.37|<0.0001
91609481|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
91609482|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.09|0.16|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.16|0.09|
91609483|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.41|
91788668|NCT02446743|183457875|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|60.0|||||TWO_SIDED|95.0|49.9|69.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||69.2|49.9|
91788669|NCT02446743|183457875|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.5|73.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||73.5|60.5|
91609484|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.43|
91609485|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.38|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.38|
91609486|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.00|0.60|
91609487|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.51|
91609488|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.86|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|0.86|
91609489|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.41|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.80|0.41|
91609490|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.73|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.73|0.39|
91609491|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.78|1.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|0.78|
91609492|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.71|
91609493|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.54|
91788670|NCT02446743|183457875|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|5.3|14.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.8|5.3|
91609494|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.06|0.78|
91609495|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.51|0.29|
91609496|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.39|
91788671|NCT02446743|183457875|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10 vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|14.0|||||TWO_SIDED|95.0|4.9|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|4.9|
91609497|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.53|
91609498|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.49|
91609499|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.52|0.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.63|0.52|
91653516|NCT02909673|183199700|EQUIVALENCE|Null Hypothesis: No difference between Fourth R Treatment and Control treatment in the rate of Physical DV perpetration. Power analyses were conducted to ensure adequate statistical power to detect minimum detectible differences of 3-6%. An intra-class correlation coefficient (ICC) =0.01 was assumed among observations of students attending the same school and was accounted for in the power estimation though the use of a variance inflation factor (VIF)|Odds Ratio (OR)|0.66||||0.05|TWO_SIDED|95.0|0.43|1.0||P-value was not adjusted for multiple test. ICC was estimated at 0.006. Type I error rate was set at 0.05|Regression, Logistic|Multilevel logistic regression used to adjust for the clustered sample design (students nested within schools).|Odds of Physical DV perpetration in the control group relative to the treatment group|||1.00|0.43|0.05
91609500|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.66|0.53|
91609501|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.64|0.42|
91609502|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
91653517|NCT01288859|183199706|NON_INFERIORITY_OR_EQUIVALENCE|The results from LC-MS/MS analysis of parent polyphenols were analyzed and expressed as the absolute changes from the baseline to reduce possible effects of inter-subject fasting variability|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED|95.0|||||ANOVA|||||||0.02
91653518|NCT01288859|183199707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|||||ANOVA|||Statistical analysis was performed using the statistical package SPSS for Windows (version15). By the analysis of variance (ANOVA) for repeated measures the subjective time curves for all measured compounds were compared and tested for the effect of treatment and of time as factors. For all tests, following a significant main effect in the ANOVA, individual means were compared using the Bonferroni test (p \< 0.05). Results were considered significant at p \< 0.05.||||0.01
91653519|NCT01288859|183199708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.01||0.04|TWO_SIDED|95.0|||||ANOVA|||||||0.04
91653520|NCT00780026|183199826|SUPERIORITY_OR_OTHER|||||||0.841||||||P value for Bacterial infection|Chi-squared|||||||0.841
91791096|NCT02880956|183460094|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91609503|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.88|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.88|0.63|
91609504|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.26|0.15|
91653521|NCT00780026|183199826|SUPERIORITY_OR_OTHER|||||||0.298||||||P-value for fungal infection|Chi-squared|||||||0.298
91653522|NCT00780026|183199826|SUPERIORITY_OR_OTHER|||||||0.585||||||P value for transplant incision wound|Chi-squared|||||||0.585
91653523|NCT00780026|183199826|SUPERIORITY_OR_OTHER|||||||0.505||||||P value for viral infection|Chi-squared|||||||0.505
91653524|NCT00780026|183199827|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
91653525|NCT00780026|183199828|EQUIVALENCE|If the p-value for the means is \> 0.05 between the groups then they will be deemed equivalent.||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
91653526|NCT00780026|183199830|SUPERIORITY_OR_OTHER|||||||0.401|||||||Fisher Exact|||||||0.401
91653527|NCT00780026|183199831|SUPERIORITY_OR_OTHER|||||||0.826||||||P value for bile leak|Chi-squared|||||||0.826
91523568|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.179
91523569|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91653528|NCT00780026|183199831|SUPERIORITY_OR_OTHER|||||||0.137||||||This is the p value for Biliary Stricture|Chi-squared|||||||0.137
91653529|NCT00780026|183199832|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
91653530|NCT01816477|183199843|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
91609505|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.35|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.35|0.23|
91609506|NCT01025336|183112598|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
91609507|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.56|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.42|
91609508|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.56|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.56|
91609509|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
91609510|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.57|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.57|0.44|
91609511|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.60|
91609512|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.97|0.63|
91609513|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.81|1.08|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.81|
91609514|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|0.99|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.99|0.74|
91609515|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
91653531|NCT01816477|183199844|SUPERIORITY_OR_OTHER|||||||0.0872|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.0872
91609516|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
91653532|NCT01816477|183199844|SUPERIORITY_OR_OTHER|||||||0.6751|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.6751
91653533|NCT01816477|183199844|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.1203
91653534|NCT01816477|183199844|SUPERIORITY_OR_OTHER|||||||0.3582|||||||Unequal Variance T-Test|||Comparison between groups for day 4.||||0.3582
91523570|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for Baseline AM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.700
91653535|NCT01816477|183199844|SUPERIORITY_OR_OTHER|||||||0.0625|||||||Unequal Variance T-Test|||Comparison between groups for day 5||||0.0625
91653536|NCT01816477|183199844|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.0484
91653537|NCT01816477|183199845|SUPERIORITY_OR_OTHER|||||||0.6465|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.6465
91653538|NCT01816477|183199845|SUPERIORITY_OR_OTHER|||||||0.9233|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.9233
91609517|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.31|
91653539|NCT01816477|183199845|SUPERIORITY_OR_OTHER|||||||0.5788|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.5788
91653540|NCT01816477|183199845|SUPERIORITY_OR_OTHER|||||||0.1036|||||||Unequal Variance T-Test|||Comparison between the groups for day 4.||||0.1036
91523571|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for AM 2-hour postprandial blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.016
91523572|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.971||95.0||||P-value is for Baseline midday premeal BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.971
91613294|NCT01958671|183121052|SUPERIORITY_OR_OTHER||Difference in least squares means|-44.01|||<|0.001|TWO_SIDED|95.0|-52.28|-35.74|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-35.74|-52.28|<0.001
91613295|NCT01958671|183121053|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.76|||<|0.001|TWO_SIDED|95.0|-2.57|-0.95|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.95|-2.57|<0.001
91613296|NCT01958671|183121053|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.16|||<|0.001|TWO_SIDED|95.0|-2.98|-1.34|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-1.34|-2.98|<0.001
91613297|NCT01958671|183121054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.85|6.95|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline eGFR.||||6.95|1.85|<0.001
91613298|NCT01958671|183121054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|3.46|13.24|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline||||13.24|3.46|<0.001
91613299|NCT01958671|183121056|SUPERIORITY_OR_OTHER||Difference in least squares means|-69.03|||<|0.001|TWO_SIDED|95.0|-83.24|-54.83|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-54.83|-83.24|<0.001
91609518|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.59|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.40|
91609519|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.96|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.96|0.58|
91609520|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.67|
91609521|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.67|0.37|
91609522|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.57|1.12|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.12|0.57|
91609523|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.09|0.85|
91609524|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.04|
91609525|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.48|0.62|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.48|
91609526|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.83|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.83|0.59|
91609527|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.57|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.57|
91609528|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.65|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.65|
91613300|NCT01958671|183121056|SUPERIORITY_OR_OTHER||Difference in least squares means|-67.33|||<|0.001|TWO_SIDED|95.0|-81.73|-52.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-52.93|-81.73|<0.001
91613301|NCT01958671|183121058|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.31||||0.015|TWO_SIDED|95.0|-5.98|-0.65||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.65|-5.98|0.015
91613302|NCT01958671|183121058|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.71||||0.213|TWO_SIDED|95.0|-4.4|0.98|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||0.98|-4.40|0.213
91613303|NCT01958671|183121060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.8||||0.039|TWO_SIDED|95.0|-3.51|-0.09||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.09|-3.51|0.039
91613304|NCT01958671|183121060|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.669|TWO_SIDED|95.0|-2.09|1.35||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||1.35|-2.09|0.669
91613305|NCT02778867|183121061|OTHER|||||||0.58||||||α \< 0.05|Fisher Exact|Two-sided||||||0.58
91613306|NCT02778867|183121062|OTHER|||||||0.06||||||α \< 0.05|Fisher Exact|Two sided||||||0.06
91609529|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.93|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.93|0.66|
91609530|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.05|0.75|
91609531|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.37|0.27|
91609532|NCT01025336|183112599|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.48|0.34|
91609533|NCT01025336|183112600|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
91609534|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.79|
91609535|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.69|0.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.90|0.69|
91609536|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
91609537|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.98|1.32|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.32|0.98|
91609538|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.62|0.81|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.81|0.62|
91609539|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
91609540|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
91609541|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.76|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.76|0.47|
91653541|NCT01816477|183199845|SUPERIORITY_OR_OTHER|||||||0.5314|||||||Unequal Variance T-Test|||Comparison between groups for day 5.||||0.5314
91523573|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Midday premeal blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91609542|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
91609543|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.30|0.96|
91653542|NCT01816477|183199845|SUPERIORITY_OR_OTHER|||||||0.7166|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.7166
91653543|NCT04128007|183199864|SUPERIORITY||Odds Ratio (OR)|14.65|||<|0.0001|TWO_SIDED|95.0|6.64|32.32|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|S-IGA Success at Week 8 Odds Ratio||32.32|6.64|<0.0001
91523574|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||P-value is for Baseline midday 2-hour postprandial BG|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.759
91609544|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.75|
91609545|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
91609546|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
91609547|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.94|1.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.75|0.94|
91609548|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
91609549|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.14|1.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.60|1.14|
91609550|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.2|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.20|
91609551|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
91609552|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.26|4.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.30|2.26|
91609553|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.53|2.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.75|1.53|
91609554|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
91609555|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.7|||||TWO_SIDED|95.0|1.97|3.7|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.70|1.97|
91613307|NCT02778867|183121065|OTHER|||||||0.9||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.90
91613308|NCT02778867|183121066|OTHER|||||||0.22||||||α \< 0.05|t-test, 2 sided|Two sample t-test||||||0.22
91613309|NCT02778867|183121067|OTHER|||||||0.71||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.71
91613310|NCT02948777|183121068|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91523575|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value Midday 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.514
91613311|NCT02948777|183121069|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91613312|NCT02948777|183121070|OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91613313|NCT02948777|183121071|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91613314|NCT02948777|183121072|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91613315|NCT02948777|183121073|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91613316|NCT02948777|183121074|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91613317|NCT02948777|183121075|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91613318|NCT02948777|183121076|OTHER|||||||0.31|||||||Kruskal-Wallis|||||||0.31
91613319|NCT02948777|183121077|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
91613320|NCT02948777|183121078|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91613321|NCT02948777|183121079|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91613322|NCT02948777|183121080|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
91613323|NCT02948777|183121081|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
91613324|NCT02948777|183121082|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
91613325|NCT02948777|183121083|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
91788672|NCT02446743|183457875|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.3|15.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||15.9|4.3|
91788673|NCT02446743|183457876|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|25.0|||||TWO_SIDED|95.0|18.2|31.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||31.4|18.2|
91653544|NCT04128007|183199865|SUPERIORITY||Odds Ratio (OR)|8.8|||<|0.0001|TWO_SIDED|95.0|3.65|21.18|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|B-IGA Success at Week 8 Odds Ratio||21.18|3.65|<0.0001
91788674|NCT02446743|183457876|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine groups difference|22.0|||||TWO_SIDED|95.0|13.2|30.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||30.1|13.2|
91653545|NCT04128007|183199866|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|95.0|2.14|7.71|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 2 Odds Ratio||7.71|2.14|<0.0001
91653546|NCT04128007|183199866|SUPERIORITY||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|2.93|9.78||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 4 Odds Ratio||9.78|2.93|<0.0001
91653547|NCT04128007|183199866|SUPERIORITY||Odds Ratio (OR)|9.74|||<|0.0001|TWO_SIDED|95.0|5.02|18.89||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 8 Odds Ratio||18.89|5.02|<0.0001
91653548|NCT04128007|183199867|SUPERIORITY||Least Squares Mean Difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-27.4|-11.8|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 4 Change from Baseline||-11.8|-27.4|<0.0001
91523576|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||P-value is for Baseline evening pre-meal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.321
91653549|NCT04128007|183199867|SUPERIORITY||Least Squares Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-19.5|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 8 Change from Baseline||-19.5|-35.5|<0.0001
91788675|NCT02446743|183457876|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|20.0|39.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||39.6|20.0|
91788676|NCT02446743|183457876|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.4|11.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.9|-3.4|
91788677|NCT02446743|183457876|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1(V72\_41)\]|vaccine group differences|12.0|||||TWO_SIDED|95.0|0.33|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|0.33|
91791097|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.785||0.966|TWO_SIDED|95.0|-1.509|1.577||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.577|-1.509|0.966
91653550|NCT04128007|183199868|SUPERIORITY||Hazard Ratio (HR)|3.94|||<|0.0001|TWO_SIDED|95.0|2.764|5.616||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Log Rank||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Time to PSSI-50 Hazard Ratio||5.616|2.764|<0.0001
91653551|NCT04128007|183199869|SUPERIORITY||Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.81|18.61||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-75 at Week 8 Odds Ratio||18.61|4.81|<0.0001
91791098|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791099|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.775||0.874|TWO_SIDED|95.0|-1.646|1.4||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.400|-1.646|0.874
91609556|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.9|||||TWO_SIDED|95.0|1.99|4.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.29|1.99|
91609557|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
91609558|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.18|1.78|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.78|1.18|
91609559|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.04|
91609560|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
91609561|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.29|0.96|
91609562|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.2|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.20|0.89|
91609563|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
91609564|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.24|1.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.61|1.24|
91609565|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.27|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.27|0.96|
91609566|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rises|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
91609567|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.82|2.88|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.88|1.82|
91613326|NCT02948777|183121084|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91613327|NCT02948777|183121085|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91613328|NCT02948777|183121086|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91613329|NCT02948777|183121087|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91613330|NCT02948777|183121088|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91613331|NCT02948777|183121089|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91613332|NCT02948777|183121091|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
91613333|NCT02948777|183121092|OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91613334|NCT01290484|183121093|SUPERIORITY_OR_OTHER||Mean percentage volume change|-3.47||||||||||||||||||
91613335|NCT02311478|183121094|OTHER|Given that this is a observational cohort design we do not use either non-inferiority or equivalence analysis. Using ANOVA we test for differences in the number of days per month of bleeding between the 90 days pre-insertion, the 90 days following insertion, and 91-180 days following insertion.|Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|0.28|<|0.05|TWO_SIDED|95.0|1.2|2.3||The p-value is not adjusted for multiple comparisons.|ANOVA|df=2||The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.||2.3|1.2|<0.05
91653552|NCT04128007|183199870|SUPERIORITY||Odds Ratio (OR)|34.45|||<|0.0001|TWO_SIDED|95.0|8.49|139.77|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-90 at Week 8 Odds Ratio||139.77|8.49|<0.0001
91653553|NCT00481247|183199872|SUPERIORITY_OR_OTHER|||||||0.0056||||||A priori threshold for statistical significance=0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Hasford Score.||||||0.0056
91653554|NCT00481247|183199873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.55|1.13||||||||1.13|0.55|
91653555|NCT00481247|183199875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.2|1.77||||||Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects||1.77|1.20|
91653556|NCT00481247|183199876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.25|1.89||||||Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects||1.89|1.25|
91653557|NCT01716754|183199881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.576|TWO_SIDED|95.0|0.35|1.78|||Regression, Logistic|||||1.78|0.35|0.576
91653558|NCT01716754|183199881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.556|TWO_SIDED|95.0|0.46|1.52|||Regression, Logistic|||||1.52|0.46|0.556
91653559|NCT01716754|183199883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.483|TWO_SIDED|95.0|0.61|2.86|||Regression, Logistic|||||2.86|0.61|0.483
91653560|NCT01716754|183199883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.261|TWO_SIDED|95.0|0.79|2.44|||Regression, Logistic|||||2.44|0.79|0.261
91653561|NCT01716754|183199885|SUPERIORITY_OR_OTHER|||||||0.604|||||||Repeated measures mixed model|||Morning||||0.604
91653562|NCT01716754|183199885|SUPERIORITY_OR_OTHER|||||||0.26|||||||Repeated measures mixed model|||Morning||||0.260
91788678|NCT02446743|183457876|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1(V72P10)\]|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-10.0|9.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.5|-10.0|
91788679|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|22.0|||||TWO_SIDED|95.0|16.5|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.6|16.5|
91653563|NCT01716754|183199885|SUPERIORITY_OR_OTHER|||||||0.937|||||||Repeated measures mixed model|||Evening||||0.937
91653564|NCT01716754|183199885|SUPERIORITY_OR_OTHER|||||||0.88|||||||Repeated measures mixed model|||Evening||||0.880
91653565|NCT01716754|183199885|SUPERIORITY_OR_OTHER|||||||0.762|||||||Repeated measures mixed model|||Overall daily||||0.762
91653566|NCT01716754|183199885|SUPERIORITY_OR_OTHER|||||||0.408|||||||Repeated measures mixed model|||Overall daily||||0.408
91653567|NCT02110706|183199901|OTHER|"A futility (non-superiority) design is a screening tool to identify whether agents should be candidates for phase III trials while minimizing costs/sample size If futility is declared, results would imply not cost effective to conduct a future phase III clinical trial If futility is not declared, suggests that there could be a clinically meaningful effect - supports exploration in a larger, phase III trial"|Odds Ratio (OR)|1.14||||0.03|ONE_SIDED|90.0||2.41|||Regression, Logistic|||"This futility design tests the following hypothesis:~H0: Rituximab improves outcome by at least 30% compared to placebo (pR - pP ≥ 0.30 - not futile) versus HA: Rituximab does not improve outcome by at least 30% compared to placebo (pR - pP \< 0.30 - futile)"||2.41||0.03
91653568|NCT02110706|183199902|SUPERIORITY||Odds Ratio (OR)|0.72||||0.63|TWO_SIDED|90.0|0.23|2.21|||t-test, 2 sided|||% of study participants with treatment related AEs||2.21|0.23|0.63
91653569|NCT02110706|183199902|SUPERIORITY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|90.0|0.27|2.11|||t-test, 2 sided|||% study participants with treatment related SAEs||2.11|0.27|0.65
91653570|NCT02110706|183199903|OTHER||Mean Difference (Final Values)|-0.11||||0.93|ONE_SIDED|90.0||2.02|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the MGC. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline MGC scores.||2.02||0.93
91653571|NCT02110706|183199904|OTHER||Mean Difference (Final Values)|-1.09||||0.39|ONE_SIDED|90.0||1.03|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the QMG. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline QMG scores.||1.03||0.39
91653572|NCT01832090|183199914|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91653573|NCT01832090|183199915|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91653574|NCT01832090|183199916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91653575|NCT01832090|183199917|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91653576|NCT01832090|183199918|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
91653577|NCT01832090|183199919|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
91653578|NCT01832090|183199922|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91653579|NCT01832090|183199923|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91653580|NCT04182204|183199929|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0017|TWO_SIDED|95.0|0.43|0.83|||Log Rank|||||0.83|0.43|0.0017
91710158|NCT04679948|183312827|OTHER||Ratio of GLSMs [%]|96.74|||||TWO_SIDED|90.0|91.55|102.23|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) = 8.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||102.23|91.55|
91710159|NCT04679948|183312828|OTHER||Ratio of GLSMs [%]|110.38|||||TWO_SIDED|90.0|107.15|113.71|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) =4.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.71|107.15|
91710160|NCT04679948|183312829|OTHER||Ratio of GLSMs [%]|108.47|||||TWO_SIDED|90.0|104.11|113.01|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) = 6.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.01|104.11|
91788680|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|14.6|28.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.9|14.6|
91788681|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|16.4|35.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||35.3|16.4|
91788682|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.8|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|60.8|
91609568|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.90|1.18|
91791100|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|5.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91523577|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Evening pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.161
91609569|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
91609570|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.63|
91791101|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.99|STANDARD_ERROR_OF_MEAN|0.794||0.213|TWO_SIDED|95.0|-0.572|2.551||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||2.551|-0.572|0.213
91791102|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791103|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.88|STANDARD_ERROR_OF_MEAN|0.695||0.208|TWO_SIDED|95.0|-0.49|2.242||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.242|-0.490|0.208
91791104|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|5.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91791105|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|0.68||0.131|TWO_SIDED|95.0|-0.307|2.365||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.365|-0.307|0.131
91609571|NCT01025336|183112600|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.51|0.99|
91710161|NCT04679948|183312830|OTHER||Ratio of GLSM [%]|99.74|||||TWO_SIDED|90.0|89.66|110.95|||||"Ratio of Geometric Least Squares Means (GLSM) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =12.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||110.95|89.66|
91609572|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
91653581|NCT04182204|183199930|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.27|0.51|||Log Rank|||||0.51|0.27|<0.0001
91653582|NCT04182204|183199931|SUPERIORITY||Difference in Response Rate|21.26|||<|0.0001|TWO_SIDED|95.0|9.58|32.94|||Cochran-Mantel-Haenszel|||||32.94|9.58|<0.0001
91653583|NCT04182204|183199932|SUPERIORITY||Difference in Response Rate|28.11|||<|0.0001|TWO_SIDED|95.0|15.89|40.33|||Cochran-Mantel-Haenszel|||||40.33|15.89|<0.0001
91788683|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|74.0|||||TWO_SIDED|95.0|65.3|81.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||81.3|65.3|
91653584|NCT04182204|183199933|SUPERIORITY||Difference in Response Rate|30.2|||||TWO_SIDED|95.0|17.71|42.68||||||||42.68|17.71|
91609573|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.16|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.16|0.91|
91609574|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
91609575|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.91|
91609576|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
91653585|NCT04182204|183199934|SUPERIORITY||Difference in Response Rate|17.4|||||TWO_SIDED|95.0|5.95|28.86||||||||28.86|5.95|
91788684|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|64.0|||||TWO_SIDED|95.0|53.6|72.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||72.3|53.6|
91788685|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|14.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.0|3.7|
91788686|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|7.0|||||TWO_SIDED|95.0|3.3|12.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.3|3.3|
91788687|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|4.5|22.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.0|4.5|
91788688|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|5.0|||||TWO_SIDED|95.0|-3.4|12.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.8|-3.4|
91791106|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|5.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91609577|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.82|3.24|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.24|1.82|
91609578|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
91609579|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.54|2.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.09|1.54|
91609580|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
91609581|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.48|2.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.55|1.48|
91609582|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
91609583|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.5|2.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.51|1.50|
91609584|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
91609585|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.31|2.18|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.18|1.31|
91609586|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
91609587|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.76|3.38|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.38|1.76|
91609588|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
91609589|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.38|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.38|
91609590|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
91609591|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.55|1.14|
91653586|NCT04182204|183199935|SUPERIORITY||Difference in Response Rate|20.36|||||TWO_SIDED|95.0|8.16|32.56||||||||32.56|8.16|
91609592|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
91609593|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.28|1.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|1.28|
91609594|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
91609595|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.53|2.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.31|1.53|
91609596|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
91609597|NCT01025336|183112601|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.24|1.84|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.84|1.24|
91609598|NCT01025336|183112602|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
91609599|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
91609600|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.20|
91609601|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.30|0.20|
91609602|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.31|
91609603|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.26|0.18|
91653587|NCT04182204|183199937|SUPERIORITY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.3|0.53||||||||0.53|0.30|
91653588|NCT04182204|183199938|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.4|0.83||||||||0.83|0.40|
91653589|NCT04182204|183199939|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.62|1.17||||||||1.17|0.62|
91653590|NCT04182204|183199940|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.45|0.91||||||||0.91|0.45|
91653591|NCT04182204|183199945|SUPERIORITY||Difference in Response Rate|10.13|||||TWO_SIDED|95.0|-2.37|22.63||||||||22.63|-2.37|
91653592|NCT04182204|183199946|SUPERIORITY||Difference in Response Rate|9.78|||||TWO_SIDED|95.0|-3.22|22.78||||||||22.78|-3.22|
91653593|NCT04182204|183199947|SUPERIORITY||Difference in Response Rate|18.25|||||TWO_SIDED|95.0|5.54|30.97||||||||30.97|5.54|
91653594|NCT00947427|183199980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||ANCOVA|||||||0.86
91788689|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|-3.3|21.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.4|-3.3|
91788690|NCT02446743|183457878|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-6.4|14.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.5|-6.4|
91788691|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|10.1|20.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|10.1|
91523578|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-value is for Baseline evening 2hour postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.297
91609604|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
91609605|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.12|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.20|0.12|
91609606|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
91609607|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.22|0.13|
91523579|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value Evening 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91609608|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
91609609|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.25|
91609610|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.08|0.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.14|0.08|
91609611|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.06|0.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.10|0.06|
91609612|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.46|0.22|
91609613|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.40|
91609614|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.29|
91609615|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.59|0.29|
91609616|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.17|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.17|
91609617|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.21|0.36|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.36|0.21|
91653595|NCT03212170|183200013|OTHER|Pearson correlation statistical test||||||0.1347|||||||two-sided hypothesis test|||||||0.1347
91791107|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|1.35|STANDARD_ERROR_OF_MEAN|0.695||0.052|TWO_SIDED|95.0|-0.014|2.719||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.719|-0.014|0.052
91609618|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.56|0.27|
91653596|NCT03212170|183200015|OTHER|Bland-Altman statistical test|Mean Difference (Final Values)|0.1308|||||TWO_SIDED|95.0|-0.282|0.544||||||||0.544|-0.282|
91653597|NCT03212170|183200016|OTHER|||||||0.2521|||||||Pearson Correlation Statistical Test|||||||0.2521
91609619|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.28|0.13|
91609620|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.39|0.20|
91653598|NCT01937364|183200019|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.0334|TWO_SIDED|90.0|-0.7275|-0.0206||One-sided p-value|z-statistic with pooled estimate||RD = Baclofen - Placebo|||-0.0206|-0.7275|0.0334
91653599|NCT01937364|183200020|SUPERIORITY_OR_OTHER|||||||0.3744|||||||Mixed Models Analysis|||Baclofen - Placebo; 24 hours||||0.3744
91653600|NCT01937364|183200020|SUPERIORITY_OR_OTHER|||||||0.7616|||||||Mixed Models Analysis|||Baclofen - Placebo; 48 hours||||0.7616
91653601|NCT01937364|183200020|SUPERIORITY_OR_OTHER|||||||0.1393|||||||Mixed Models Analysis|||Baclofen - Placebo; 72 hours||||0.1393
91653602|NCT01937364|183200021|SUPERIORITY_OR_OTHER|||||||0.33||||||Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose|Wilcoxon (Mann-Whitney)|||||||0.33
91653603|NCT01937364|183200021|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Baclofen - Placebo; Total Ativan 1mg PO equivalent dose||||0.80
91609621|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.67|0.28|
91609622|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.48|
91609623|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.49|
91609624|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.65|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.65|0.42|
91653604|NCT06394973|183200051|OTHER||Mean Difference (Final Values)|-0.49||||0.376|TWO_SIDED||||||Mixed Models Analysis|||||||0.376
91653605|NCT06394973|183200051|OTHER||Mean Difference (Final Values)|-0.36||||0.518|TWO_SIDED||||||Mixed Models Analysis|||||||0.518
91791108|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|5.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91523580|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Baseline 3 AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.199
91609625|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.32|0.20|
91609626|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
91609627|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.29|
91609628|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
91609629|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
91609630|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.36|
91609631|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.58|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.58|0.35|
91609632|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.62|0.39|
91609633|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.54|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.54|0.34|
91609634|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.23|
91609635|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.24|0.15|
91788692|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|12.0|||||TWO_SIDED|95.0|7.5|18.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.1|7.5|
91523581|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.693
91609636|NCT01025336|183112602|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.42|
91609637|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.50|0.36|
91609638|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.48|0.36|
91609639|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.33|0.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.44|0.33|
91609640|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.26|0.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.37|0.26|
91609641|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.42|
91609642|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.64|1.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.14|0.64|
91609643|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
91609644|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.86|1.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.18|0.86|
91609645|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
91609646|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.81|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.46|0.81|
91653606|NCT04071769|183200052|OTHER|||||||0.27|||||||t-test, 2 sided|||Null hypothesis: there is no difference in the Xenon MRI measure of RBC-to-Membrane (RBC:M) at baseline vs. 3 months after initiating anti-fibrotic therapy.||||0.27
91788693|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|12.3|29.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||29.9|12.3|
91609647|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.34|
91609648|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.66|1.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.09|0.66|
91609649|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.37|
91609650|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.77|0.43|
91609651|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.30|
91653607|NCT04071769|183200053|OTHER|Baseline to 3 months||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
91653608|NCT04071769|183200053|OTHER|Baseline to 6 months||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91653609|NCT04071769|183200053|OTHER|Baseline to 12 months||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91653610|NCT04071769|183200054|OTHER|Baseline to 3 months||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91653611|NCT04071769|183200054|OTHER|Baseline to 6 months||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91653612|NCT04071769|183200054|OTHER|Baseline to 12 months||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
91653613|NCT02489318|183200116|SUPERIORITY||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.391|0.6|||Log Rank|||||0.600|0.391|<0.0001
91788694|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|66.0|||||TWO_SIDED|95.0|59.6|72.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||72.4|59.6|
91791109|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|1.062||0.866|TWO_SIDED|95.0|-1.908|2.268||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.268|-1.908|0.866
91791110|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|6.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91523582|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Baseline AM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.021
91609652|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.47|0.98|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.98|0.47|
91609653|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.72|1.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.01|0.72|
91609654|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.71|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.00|0.71|
91609655|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.66|0.50|
91609656|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.56|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.56|
91791111|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.048||0.66|TWO_SIDED|95.0|-1.599|2.523||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.523|-1.599|0.660
91791112|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|6.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91609657|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.54|
91609658|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.05|0.78|
91609659|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.59|
91613336|NCT02311478|183121094|EQUIVALENCE|α of 0.05 or lower.|Mean Difference (Final Values)|0.93|||<|0.05|TWO_SIDED|95.0|0.36|1.5|||t-test, 2 sided|||The estimation parameter compares the 90 days following to the 90 days prior.||1.5|0.36|<0.05
91613337|NCT03242928|183121097|SUPERIORITY||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.037|=|0.021|TWO_SIDED|95.0|-0.161|-0.013|||ANCOVA|||||-0.013|-0.161|= 0.021
91613338|NCT03242928|183121098|SUPERIORITY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.077|=|0.025|TWO_SIDED|95.0|-0.331|-0.023|||ANOVA|||||-0.023|-0.331|= 0.025
91613339|NCT03242928|183121099|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.038|=|0.072|TWO_SIDED|95.0|-0.146|0.006|||ANCOVA|||||0.006|-0.146|= 0.072
91613340|NCT00943319|183121109|OTHER||Median Survival time|161.0|||||TWO_SIDED|95.0|121.0|305.0|||Product limit survival estimate|||||305|121|
91613341|NCT00943319|183121110|OTHER||Median Disease Free Survival Time|172.0|||||TWO_SIDED|95.0|85.0|436.0||||||Estimated median survival time||436|85|
91613342|NCT02043301|183121111|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|120.96|||||TWO_SIDED|90.0|101.99|143.45|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||143.45|101.99|
91613343|NCT02043301|183121111|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|94.93|||||TWO_SIDED|90.0|80.2|112.38|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||112.38|80.20|
91791113|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|1.91|STANDARD_ERROR_OF_MEAN|1.062||0.074|TWO_SIDED|95.0|-0.184|3.995||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.995|-0.184|0.074
91791114|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791115|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.111||0.747|TWO_SIDED|95.0|-2.545|1.828||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.828|-2.545|0.747
91791116|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.99|||TWO_SIDED|||||||||Week 96||||
91791117|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|1.095||0.891|TWO_SIDED|95.0|-2.004|2.304||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.304|-2.004|0.891
91609660|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.53|
91653614|NCT02489318|183200117|SUPERIORITY||Hazard Ratio (HR)|0.651|||<|0.0001|TWO_SIDED|95.0|0.534|0.793|||Log Rank|||||0.793|0.534|<0.0001
91609661|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.51|
91609662|NCT01025336|183112603|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.15|0.75|
91609663|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|6.05|10.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.67|6.05|
91609664|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.3|||||TWO_SIDED|95.0|6.65|10.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.45|6.65|
91609665|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.8|||||TWO_SIDED|95.0|3.71|6.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.14|3.71|
91609666|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.2|||||TWO_SIDED|95.0|2.59|3.91|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.91|2.59|
91609667|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.4|||||TWO_SIDED|95.0|3.67|5.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.26|3.67|
91788695|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|70.0|||||TWO_SIDED|95.0|60.8|77.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||77.0|60.8|
91609668|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|2.2|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.20|
91609669|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.9|||||TWO_SIDED|95.0|7.8|21.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.34|7.80|
91609670|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|6.26|12.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||12.92|6.26|
91609671|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.5|||||TWO_SIDED|95.0|3.71|8.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.07|3.71|
91609672|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.2|||||TWO_SIDED|95.0|4.35|8.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.80|4.35|
91609673|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|9.71|16.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.30|9.71|
91653615|NCT02489318|183200118|SUPERIORITY||Hazard Ratio (HR)|0.469|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.630|0.350|<.0001
91653616|NCT02489318|183200119|SUPERIORITY||Hazard Ratio (HR)|0.868||||0.1966|TWO_SIDED|95.0|0.7|1.076|||Log Rank|||||1.076|0.700|0.1966
91653617|NCT02489318|183200120|SUPERIORITY||Hazard Ratio (HR)|0.794||||0.1563|TWO_SIDED|95.0|0.576|1.094|||Log Rank|||||1.094|0.576|0.1563
91653618|NCT02489318|183200121|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.3608|TWO_SIDED|95.0|0.615|1.194|||Log Rank|||||1.194|0.615|0.3608
91653619|NCT02261428|183200122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.95|||<|0.05|TWO_SIDED|95.0|1.79|8.73|||Wilcoxon (Mann-Whitney)|||||8.73|1.79|<0.05
91791118|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|8.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91609674|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.5|||||TWO_SIDED|95.0|5.59|10.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.02|5.59|
91609675|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.1|||||TWO_SIDED|95.0|9.56|23.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.81|9.56|
91710162|NCT04679948|183312831|OTHER||Ratio of GLSMs [%]|71.32|||||TWO_SIDED|90.0|44.64|113.96|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =87.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.96|44.64|
91523583|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91523584|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value is for Baseline midday 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.567
91523585|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for Midday 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
91523586|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.994||95.0||||P-value is for Baseline PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.994
91523587|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91523588|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.436
91523589|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91523590|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||P-value is for Baseline mean all 2hour PP BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.628
91523591|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91523592|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value is for Baseline AM/PM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.677
91523593|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91523594|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value is for Baseline mean all premeal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.364
91523595|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for Mean of all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.055
91609676|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.3|||||TWO_SIDED|95.0|8.66|17.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.38|8.66|
91523596|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Baseline AM/PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.165
91523597|NCT00279201|182923049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91523598|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value is for Baseline mean of all BG values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.464
91523599|NCT00279201|182923049|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for Mean of all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.305
91523600|NCT00279201|182923050|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|ANCOVA model with treatment, baseline, country, TZD use, and sulfo use.||||||0.003
91523601|NCT00279201|182923051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 6.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523602|NCT00279201|182923051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 12.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523603|NCT00279201|182923051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 18|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523604|NCT00279201|182923051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523605|NCT00279201|182923051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523606|NCT00279201|182923052|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Actual weight at baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.497
91609677|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.29|9.89|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.89|4.29|
91609678|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.8|||||TWO_SIDED|95.0|12.59|34.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||34.24|12.59|
91523607|NCT00279201|182923052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
91609679|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|21.4|||||TWO_SIDED|95.0|14.56|31.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||31.46|14.56|
91609680|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|7.24|17.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.01|7.24|
91609681|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.2|||||TWO_SIDED|95.0|19.75|52.57|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||52.57|19.75|
91609682|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|47.2|||||TWO_SIDED|95.0|34.0|65.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||65.43|34.00|
91609683|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.4|||||TWO_SIDED|95.0|12.95|29.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||29.17|12.95|
91609684|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|7.79|21.13|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.13|7.79|
91653620|NCT03679741|183200129|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.99|||TWO_SIDED|95.0|-1.9|5.8|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as test minus control|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||5.8|-1.9|
91523608|NCT00279201|182923052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Actual weight at Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
91609685|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|8.56|18.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.68|8.56|
91609686|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.8|||||TWO_SIDED|95.0|4.54|10.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.10|4.54|
91609687|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|8.16|20.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||20.02|8.16|
91609688|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.15|16.23|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.23|8.15|
91609689|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.75|11.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.25|5.75|
91788696|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|65.0|||||TWO_SIDED|95.0|55.2|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|55.2|
91788697|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|4.9|13.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.6|4.9|
91788698|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.2|9.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.7|1.2|
91609690|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.0|||||TWO_SIDED|95.0|12.99|30.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.76|12.99|
91653621|NCT03679741|183200130|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|3.97|STANDARD_DEVIATION|1.138|||TWO_SIDED|95.0|2.27|6.62|||Bayesian multinomial random-effects mode|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||6.62|2.27|
91653622|NCT03679741|183200131|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.022|STANDARD_DEVIATION|0.0074|||TWO_SIDED|95.0|-0.037|-0.008|||Bayesian multivariate normal model|with random effects|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the low luminance high contrast lighting condition.||-0.008|-0.037|
91653623|NCT03679741|183200131|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.034|STANDARD_DEVIATION|0.0075|||TWO_SIDED|95.0|-0.049|-0.02|||Bayesian multivariate normal model|with random effect|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the high illumination low contrast lighting condition.||-0.020|-0.049|
91788699|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|15.0|||||TWO_SIDED|95.0|7.5|22.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.6|7.5|
91788700|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-6.8|10.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.0|-6.8|
91523609|NCT00279201|182923052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 18.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
91609691|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.3|||||TWO_SIDED|95.0|16.5|30.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.06|16.50|
91609692|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.8|||||TWO_SIDED|95.0|7.07|13.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||13.63|7.07|
91609693|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|8.82|16.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.34|8.82|
91609694|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.0|||||TWO_SIDED|95.0|10.21|16.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.66|10.21|
91523610|NCT00279201|182923052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
91609695|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|5.86|9.94|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.94|5.86|
91609696|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.2|||||TWO_SIDED|95.0|8.05|18.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.34|8.05|
91609697|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.2|||||TWO_SIDED|95.0|12.77|23.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.24|12.77|
91609698|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.01|16.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.45|8.01|
91609699|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|7.89|18.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.19|7.89|
91788701|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-9.8|15.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|-9.8|
91609700|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.7|||||TWO_SIDED|95.0|5.02|8.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.92|5.02|
91609701|NCT01025336|183112604|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.7|||||TWO_SIDED|95.0|3.52|6.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.29|3.52|
91609702|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.7|||||TWO_SIDED|95.0|3.05|4.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.49|3.05|
91609703|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.92|2.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.81|1.92|
91609704|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.83|2.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.50|1.83|
91609705|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.32|1.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||1.74|1.32|
91788702|NCT02446743|183457879|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.8|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.7|-7.8|
91523611|NCT00279201|182923052|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Actual weight at Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.0001
91609706|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.82|11.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.09|5.82|
91609707|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.25|8.21|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.21|4.25|
91609708|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.9|||||TWO_SIDED|95.0|3.96|6.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.00|3.96|
91609709|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.58|3.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.79|2.58|
91609710|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.9|||||TWO_SIDED|95.0|8.56|16.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.49|8.56|
91609711|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.5|||||TWO_SIDED|95.0|2.59|4.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.76|2.59|
91653624|NCT03679741|183200132|SUPERIORITY|A superiority margin of 90% was used. Superiority was concluded if the lower limit of the 95% credible interval was above 90%|Mean Percentage of eyes|100.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|99.0|100.0|||Bayesian beta- binomial model|for correlated binary data||It was calculated that 65 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100.0|99.0|
91791119|NCT02880956|183460095|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|1.12||0.621|TWO_SIDED|95.0|-1.65|2.759||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.759|-1.650|0.621
91791120|NCT02880956|183460095|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|8.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91523612|NCT00279201|182923053|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for Hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.016
91609712|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.61|9.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.03|4.61|
91609713|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.32|4.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.24|2.32|
91609714|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.4|||||TWO_SIDED|95.0|5.23|10.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.33|5.23|
91609715|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.6|||||TWO_SIDED|95.0|4.07|7.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.69|4.07|
91609716|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.5|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|2.50|
91609717|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.1|4.04|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.04|2.10|
91609718|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.26|3.71|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.71|2.26|
91609719|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.23|3.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.63|2.23|
91653625|NCT03679741|183200133|NON_INFERIORITY|A non-inferiority cumulative odds ratio margin of 2 was used. This margin corresponds to no more than a 5% difference between the Test and Control lenses assuming the Control reference rate does not exceed 5%. Non-inferiority was declared if the upper bound of the 95% credible interval was below 2.|Mean Difference (Final Values)|0.001|STANDARD_DEVIATION|0.003|||TWO_SIDED|95.0|-0.004|0.008|||Bayesian beta-binomial hierarchical||Mean difference was calculated as Test minus Control.|It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods.||0.008|-0.004|
91609720|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.1|||||TWO_SIDED|95.0|3.16|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|3.16|
91609721|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.5|||||TWO_SIDED|95.0|2.06|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.06|
91791121|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.147|TWO_SIDED|95.0|-0.01|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.064|-0.010|0.147
91791122|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91791123|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.018||0.795|TWO_SIDED|95.0|-0.041|0.031||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.031|-0.041|0.795
91791124|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.147|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91609722|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.0|||||TWO_SIDED|95.0|2.46|3.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.60|2.46|
91609723|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.7|||||TWO_SIDED|95.0|2.24|3.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.15|2.24|
91609724|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.55|7.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.76|4.55|
91609725|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.0|||||TWO_SIDED|95.0|3.13|5.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.17|3.13|
91609726|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.9|||||TWO_SIDED|95.0|5.16|9.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.25|5.16|
91609727|NCT01025336|183112605|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.24|3.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.40|2.24|
91653626|NCT03679741|183200134|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|1.29|||TWO_SIDED|95.0|3.1|8.1|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||8.1|3.1|
91653627|NCT03679741|183200135|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.56|||TWO_SIDED|95.0|-0.6|5.5|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||5.5|-0.6|
91653628|NCT03679741|183200136|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|1.73|STANDARD_DEVIATION|0.459|||TWO_SIDED|95.0|1.0|2.82|||Bayesian multinomial random-effects|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||2.82|1.00|
91653629|NCT01399736|183200182|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.55|||Chi-squared|||||0.55|0.22|<0.001
91609728|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.08|1.02|
91609729|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.14|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.99|1.14|
91609730|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.22|3.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.06|1.22|
91609731|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|1.15|2.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.56|1.15|
91653630|NCT01399736|183200183|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.7|TWO_SIDED|95.0|0.25|2.56|||Chi-squared|||||2.56|0.25|0.70
91653631|NCT01399736|183200184|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.25|4.01|||Chi-squared|||||4.01|0.25|1.00
91653632|NCT01399736|183200185|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.1|TWO_SIDED|95.0|0.22|1.13|||Chi-squared|||||1.13|0.22|0.10
91653633|NCT01399736|183200186|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.29|TWO_SIDED|95.0|0.22|1.59|||Chi-squared|||||1.59|0.22|0.29
91609732|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.36|3.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.53|1.36|
91788703|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group ratio of GMTs|2.54|||||TWO_SIDED|95.0|2.07|3.12|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.12|2.07|
91788704|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|2.13|||||TWO_SIDED|95.0|1.66|2.72|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.72|1.66|
91788705|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|2.96|||||TWO_SIDED|95.0|2.15|4.07|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.07|2.15|
91788706|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||21|12|
91791125|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.095|TWO_SIDED|95.0|-0.006|0.069||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.069|-0.006|0.095
91609733|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.15|2.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.91|1.15|
91609734|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|2.8|||||TWO_SIDED|95.0|1.8|4.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.44|1.80|
91609735|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|0.99|2.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.96|0.99|
91609736|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.1|||||TWO_SIDED|95.0|0.73|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.62|0.73|
91653634|NCT01399736|183200187|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.24|0.57|||Chi-squared|||||0.57|0.24|<0.001
91791126|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|0.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
91609737|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.02|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.39|1.02|
91609738|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.38|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.45|1.38|
91609739|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.53|3.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.12|1.53|
91653635|NCT01399736|183200188|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8|TWO_SIDED|95.0|0.29|5.02|||Chi-squared|||||5.02|0.29|0.80
91653636|NCT00948675|183200223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Log Rank|||||||0.176
91653637|NCT00948675|183200224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Log Rank|||||||0.610
91653638|NCT00948675|183200225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615||95.0|||||Log Rank|||||||0.615
91791127|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.39|TWO_SIDED|95.0|-0.028|0.072||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.072|-0.028|0.390
91609740|NCT01025336|183112606|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.18|2.82|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.82|1.18|
91609741|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.25|1.02|
91609742|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.78|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.44|0.78|
91653639|NCT00948675|183200226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.414||95.0|||||Pearson Chi-square Test|||||||0.414
91523613|NCT00279201|182923053|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Overall hypoglycemic episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.037
91653640|NCT00948675|183200227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.575||95.0|||||Pearson Chi-square Test|||||||0.575
91653641|NCT03335371|183200252|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.087|<|0.0001|TWO_SIDED|95.0|-0.39|-0.04|||ANCOVA|||||-0.04|-0.39|<0.0001
91653642|NCT06331156|183200269|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the group difference (Co-administration group minus Staggered group) in seroconversion rate is greater than or equal to (\>=) -10% for the anti-poliovirus type 1 antibodies.|Difference in seroconversion rate|0.1|||||TWO_SIDED|95.0|-3.14|3.76|||||The asymptotic standardized 95% CI for the difference in seroconversion rate for IPV at month 3.5 between Co-administration group minus staggered group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).||3.76|-3.14|
91653643|NCT06331156|183200269|NON_INFERIORITY|NI was to be demonstrated if the LL of the 2-sided 95% CI for the group difference (Co-administration group minus Staggered group) in seroconversion rate is \>= -10% for the anti-poliovirus type 2 antibodies.|Difference in seroconversion rate|-0.7|||||TWO_SIDED|95.0|-3.86|2.3|||||The asymptotic standardized 95% CI for the difference in seroconversion rate for IPV at month 3.5 between Co-administration group minus staggered group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).||2.30|-3.86|
91653644|NCT06331156|183200269|NON_INFERIORITY|NI was to be demonstrated if the LL of the 2-sided 95% CI for the group difference (Co-administration group minus Staggered group) in seroconversion rate is \>= -10% for the anti-poliovirus type 3 antibodies.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-2.63|2.99|||||The asymptotic standardized 95% CI for the difference in seroconversion rate for IPV at Month 3.5 between Co-administration group minus Staggered group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).||2.99|-2.63|
91653645|NCT05845645|183200278|OTHER||GLSM Ratio|0.8269|||||TWO_SIDED|90.0|0.7535|0.9076|||||The geometric least square mean (GLSM) ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For normal gastric pH||0.9076|0.7535|
91653646|NCT05845645|183200278|OTHER||GLSM ratio|0.7053|||||TWO_SIDED|90.0|0.6427|0.7741|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Normal gastric pH||0.7741|0.6427|
91653647|NCT05845645|183200278|OTHER||GLSM ratio|0.8529|||||TWO_SIDED|90.0|0.7771|0.9361|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg.|For Normal gastric pH||0.9361|0.7771|
91788707|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|20.0|||||TWO_SIDED|95.0|14.0|28.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||28|14|
91653648|NCT05845645|183200278|OTHER||GLSM ratio|1.563|||||TWO_SIDED|90.0|1.376|1.776|||||The GLSM ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Elevated gastric pH||1.776|1.376|
91653649|NCT05845645|183200278|OTHER||GLSM ratio|1.415|||||TWO_SIDED|90.0|1.248|1.604|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Elevated gastric pH||1.604|1.248|
91653650|NCT05845645|183200278|OTHER||GLSM ratio|0.905|||||TWO_SIDED|90.0|0.7972|1.027|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg.|For Elevated gastric pH||1.027|0.7972|
91653651|NCT05845645|183200279|OTHER||GLSM ratio|0.9529|||||TWO_SIDED|90.0|0.9052|1.003|||||The GLSM ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Normal gastric pH||1.003|0.9052|
91653652|NCT05845645|183200279|OTHER||GLSM ratio|0.922|||||TWO_SIDED|90.0|0.8758|0.9706|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Normal gastric pH||0.9706|0.8758|
91788708|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|14.0|||||TWO_SIDED|95.0|9.05|20.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||20|9.05|
91653653|NCT05845645|183200279|OTHER||GLSM ratio|0.9676|||||TWO_SIDED|90.0|0.9191|1.019|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg.|For Normal gastric pH||1.019|0.9191|
91791128|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91653654|NCT05845645|183200279|OTHER||GLSM ratio|1.059|||||TWO_SIDED|90.0|1.001|1.12|||||The GLSM ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Elevated gastric pH||1.120|1.001|
91653655|NCT05845645|183200279|OTHER||GLSM ratio|1.038|||||TWO_SIDED|90.0|0.9826|1.097|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Elevated gastric pH||1.097|0.9826|
91653656|NCT05845645|183200279|OTHER||GLSM ratio|0.9804|||||TWO_SIDED|90.0|0.9273|1.037|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg.|For Elevated gastric pH||1.037|0.9273|
91653657|NCT05845645|183200280|OTHER||GLSM ratio|0.9519|||||TWO_SIDED|90.0|0.9011|1.006|||||The GLSM ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Normal gastric pH||1.006|0.9011|
91791129|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.898|TWO_SIDED|95.0|-0.052|0.045||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.045|-0.052|0.898
91653658|NCT05845645|183200280|OTHER||GLSM ratio|0.9255|||||TWO_SIDED|90.0|0.8762|0.9777|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Normal gastric pH||0.9777|0.8762|
91653659|NCT05845645|183200280|OTHER||GLSM ratio|0.9723|||||TWO_SIDED|90.0|0.9204|1.027|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg.|For Normal gastric pH||1.027|0.9204|
91653660|NCT05845645|183200280|OTHER||GLSM ratio|1.053|||||TWO_SIDED|90.0|0.994|1.116|||||The GLSM ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Elevated gastric pH||1.116|0.9940|
91653661|NCT05845645|183200280|OTHER||GLSM ratio|1.027|||||TWO_SIDED|90.0|0.971|1.086|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg.|For Elevated gastric pH||1.086|0.9710|
91710163|NCT04679948|183312832|OTHER||Ratio of GLSMs [%]|126.85|||||TWO_SIDED|90.0|119.15|135.05|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =10.1."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||135.05|119.15|
91710164|NCT04679948|183312833|OTHER||Ratio of GLSMs [%]|130.25|||||TWO_SIDED|90.0|121.25|139.92|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =11.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||139.92|121.25|
91653662|NCT05845645|183200280|OTHER||GLSM ratio|0.9747|||||TWO_SIDED|90.0|0.9208|1.032|||||The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg.|For Elevated gastric pH||1.032|0.9208|
91653663|NCT02649231|183200296|SUPERIORITY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.28|1.75||||||Confirmed alcohol relapse by drug condition at 6 months using the Alcohol Timeline-Followback. Logistic regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and alcohol education).||1.75|0.28|
91653664|NCT02649231|183200297|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|1.1|19.0||||||Linear regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and psychoeducation). Only participants with a minimum of 159 days of completed drinking self-report data were included in the main ITT analysis as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.||19.0|1.1|
91523614|NCT00279201|182923053|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for Nocturnal hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.834
91653665|NCT02970669|183200300|SUPERIORITY||Ratio of Geometric Means (SacVal/Ena)|0.9456||||0.0895|TWO_SIDED|95.0|0.8863|1.0088|||ANCOVA|model for a log-scaled response with treatment group as a class variable and the baseline value in logarithmic scale as a continuous covariate.||||1.0088|0.8863|0.0895
91653666|NCT02970669|183200301|SUPERIORITY||Mean Difference (Net)|293.6||||0.6316|TWO_SIDED|95.0|-916.5|1503.8|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||1503.8|-916.5|0.6316
91653667|NCT02970669|183200303|SUPERIORITY||Mean Difference (Net)|2.038||||0.057|TWO_SIDED|95.0|-0.062|4.138|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.138|-0.062|0.0570
91653668|NCT02970669|183200304|SUPERIORITY||Mean Difference (Net)|2.478||||0.0121|TWO_SIDED|95.0|0.553|4.403|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.403|0.553|0.0121
91653669|NCT01714505|183200331|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Paired t-tests: compare LBGI, carbohydrates for hypoglycemia treatment, % of time in range and average BG on CLC vs OL.||||||0.003
91653670|NCT01714505|183200332|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
91653671|NCT01714505|183200333|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91653672|NCT00249821|183200360|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||"Month 12: Analysis of co-variance (ANCOVA) method with covariates height and age at baseline was used to calculate presented p-value."||||0.001
91653673|NCT00249821|183200361|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.012
91653674|NCT00249821|183200361|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
91710165|NCT02494401|183312834|SUPERIORITY|||||||0.87||||||p value of baseline comparison.|Wilcoxon (Mann-Whitney)|||||||0.87
91653675|NCT00249821|183200362|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.022
91653676|NCT00249821|183200362|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
91653677|NCT00249821|183200363|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.029
91653678|NCT00249821|183200364|SUPERIORITY_OR_OTHER|||||||0.972||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.972
91653679|NCT00249821|183200365|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.058
91653680|NCT00249821|183200365|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.026
91788709|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.26|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|1.26|
91788710|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.3|||||TWO_SIDED|95.0|1.11|1.51|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.51|1.11|
91788711|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.7|||||TWO_SIDED|95.0|1.27|2.28|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.28|1.27|
91788712|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.26|||||TWO_SIDED|95.0|0.94|1.68|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.68|0.94|
91791130|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
91653681|NCT00249821|183200366|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.793
91653682|NCT00249821|183200366|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.055
91653683|NCT00814320|183200379|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.025|||<|0.0001|ONE_SIDED|99.0||0.046||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only||0.046||<0.0001
91653684|NCT01488578|183200449|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653685|NCT01488578|183200452|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.032|TWO_SIDED||||||Chi-squared|||||||=0.032
91653686|NCT01488578|183200453|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653687|NCT01488578|183200454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653688|NCT01488578|183200455|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653689|NCT01488578|183200456|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||The Hosmer-Lemeshow Goodness-of-Fit TEST|||||||<0.001
91653690|NCT01488578|183200458|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.006|TWO_SIDED||||||Chi-squared|||||||=0.006
91653691|NCT01488578|183200459|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653692|NCT01488578|183200460|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Chi-squared|||||||=0.015
91653693|NCT01488578|183200461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653694|NCT01488578|183200462|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91653695|NCT05550532|183200466|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.23|=|0.67|TWO_SIDED|95.0|-2.95|1.9|||Mixed Model for Repeated Measures Model|||||1.90|-2.95|=0.670
91653696|NCT05550532|183200471|SUPERIORITY||Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-1.13|1.71||||||||1.71|-1.13|
91653697|NCT02780661|183200481|OTHER||Least square (LS) mean difference|-0.86||||0.0144|TWO_SIDED|95.0|-1.53|-0.196||Log10 change from baseline in aerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||-0.196|-1.530|0.0144
91710166|NCT02494401|183312834|SUPERIORITY|||||||0.32||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.32
91710167|NCT02494401|183312834|SUPERIORITY|||||||0.3||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.3
91710168|NCT02494401|183312835|SUPERIORITY|||||||0.08||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.08
91609743|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.06|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|1.06|
91609744|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.41|1.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.04|0.41|
91710169|NCT02494401|183312835|SUPERIORITY|||||||0.05||||||p value 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.05
91788713|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.32|||||TWO_SIDED|95.0|0.85|2.05|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.05|0.85|
91609745|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.82|5.24|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.24|1.82|
91613344|NCT02043301|183121112|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|127.65|||||TWO_SIDED|90.0|107.19|152.02|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||152.02|107.19|
91613345|NCT02043301|183121112|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|86.16|||||TWO_SIDED|90.0|72.49|102.4|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||102.40|72.49|
91788714|NCT02446743|183457880|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.81|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|0.81|
91788715|NCT02446743|183457885|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|8.0|21.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||21.6|8.0|
91788716|NCT02446743|183457885|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|16.0|||||TWO_SIDED|95.0|10.8|23.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||23.1|10.8|
91788717|NCT02446743|183457885|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||20.1|11.0|
91609746|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|2.4|||||TWO_SIDED|95.0|1.43|4.11|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.11|1.43|
91609747|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|0.96|
91609748|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.6|||||TWO_SIDED|95.0|0.88|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.04|0.88|
91609749|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.54|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.54|0.64|
91609750|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.71|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.93|0.71|
91653698|NCT02780661|183200482|OTHER||LS mean difference|-0.48||||0.1879|TWO_SIDED|95.0|-1.23|0.261||Log10 change from baseline in anaerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||0.261|-1.230|0.1879
91653699|NCT01691508|183200496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.008|TWO_SIDED|95.0|1.25|4.56|||Proportional odds model|||||4.56|1.25|0.008
91609751|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|1.01|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.04|1.01|
91609752|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.84|2.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.06|0.84|
91653700|NCT00395226|183200520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.47|1.62||The a priori significance threshold level was 0.05 (two-sided)|ANCOVA|The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.|The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model|"The null hypothesis was no group differences. The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm."||1.62|-0.47|0.2840
91710170|NCT02494401|183312835|SUPERIORITY|||||||0.008||||||p value 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.008
91788718|NCT02446743|183457885|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|54.0|||||TWO_SIDED|95.0|43.0|63.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||63.3|43.0|
91523615|NCT00279201|182923053|SUPERIORITY_OR_OTHER|||||||0.585||95.0||||P-value is for Nocturnal hypoglycemic episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.585
91523616|NCT00279201|182923053|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Severe hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.241
91523617|NCT00279201|182923053|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-value is for Severe hypoglycemic episodes overall. Initiation phase and maintenance phase are included.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.080
91788719|NCT02446743|183457885|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|22.0|40.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.1|22.0|
91523618|NCT00279201|182923054|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.009
91523619|NCT00279201|182923054|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.420
91523620|NCT00279201|182923054|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.165
91523621|NCT00279201|182923054|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.167
91523622|NCT00279201|182923054|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.006
91523623|NCT00279201|182923054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||<0.001
91523624|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91523625|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91523626|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91710171|NCT02494401|183312836|SUPERIORITY|||||||0.68||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.68
91710172|NCT02494401|183312836|SUPERIORITY|||||||0.83||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.83
91710173|NCT02494401|183312836|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
91710174|NCT02494401|183312837|SUPERIORITY|||||||0.96||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.96
91710175|NCT02494401|183312837|SUPERIORITY|||||||0.69||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.69
91788720|NCT02446743|183457885|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|41.0|||||TWO_SIDED|95.0|33.6|47.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||47.2|33.6|
91788721|NCT02446743|183457886|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|20.0|||||TWO_SIDED|95.0|15.0|25.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||25.4|15.0|
91788722|NCT02446743|183457886|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|18.0|||||TWO_SIDED|95.0|10.7|27.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.0|10.7|
91788723|NCT02446743|183457886|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|15.6|28.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||28.8|15.6|
91788724|NCT02446743|183457886|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|12.0|||||TWO_SIDED|95.0|8.0|16.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.8|8.0|
91788725|NCT02446743|183457886|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.8|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.6|12.8|
91788726|NCT02446743|183457886|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|6.0|||||TWO_SIDED|95.0|1.5|12.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.2|1.5|
91609753|NCT01025336|183112607|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.89|5.2|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.20|1.89|
91653701|NCT02059993|183200521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.||||<0.05
91653702|NCT02059993|183200522|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91710176|NCT02494401|183312837|SUPERIORITY|||||||0.6||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.6
91710177|NCT02494401|183312838|SUPERIORITY|||||||0.89||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.89
91710178|NCT02494401|183312838|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91710179|NCT02494401|183312838|SUPERIORITY|||||||0.56||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.56
91788727|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|27.0|||||TWO_SIDED|95.0|21.9|33.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.3|21.9|
91788728|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|21.8|40.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.3|21.8|
91788729|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|19.2|33.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.1|19.2|
91788730|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|14.3|24.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||24.3|14.3|
91609754|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.72|1.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.51|0.72|
91609755|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.52|0.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.94|0.52|
91609756|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.58|1.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.47|0.58|
91609757|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.25|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.59|0.25|
91609758|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.85|2.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.32|0.85|
91791131|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.026||0.8|TWO_SIDED|95.0|-0.044|0.057||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.057|-0.044|0.800
91609759|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.82|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.13|0.82|
91609760|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.37|0.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.97|0.37|
91609761|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.54|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.70|0.54|
91710180|NCT02494401|183312839|SUPERIORITY|||||||0.69||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.69
91710181|NCT02494401|183312839|SUPERIORITY|||||||0.29||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.29
91710182|NCT02494401|183312839|SUPERIORITY|||||||0.07||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.07
91710183|NCT02494401|183312840|SUPERIORITY|||||||0.28||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.28
91710184|NCT02494401|183312840|SUPERIORITY|||||||0.16||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.16
91710185|NCT02494401|183312840|SUPERIORITY|||||||0.23||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.23
91791132|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.18|||TWO_SIDED|||||||||Week 48||||
91791133|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.977|TWO_SIDED|95.0|-0.066|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.066|0.977
91653703|NCT02655237|183200524|NON_INFERIORITY|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between Relugolix 40 mg group and leuprorelin group (Relugolix 40 mg group - leuprorelin group), using Farrington and Manning (FM) method. If the lower boundary of the 95% CI was greater or equal to the non-inferiority margin of -15%, then the non-inferiority of Relugolix 40 mg to leuprorelin was concluded.|Difference in percentage|-0.9||||0.0013|TWO_SIDED|95.0|-10.098|8.346|||Farrington and Manning (FM)||Relugolix 40 mg-Leuprorelin|||8.346|-10.098|0.0013
91609762|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.41|0.59|
91653704|NCT02655237|183200525|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|32.5|||||TWO_SIDED|95.0|20.953|44.134|||||Relugolix 40 mg-Leuprorelin|||44.134|20.953|
91653705|NCT02655237|183200526|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-10.6|||||TWO_SIDED|95.0|-18.337|-2.883|||||Relugolix 40 mg-Leuprorelin|||-2.883|-18.337|
91788731|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.1|27.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.5|12.1|
91788732|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|13.3|26.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||26.4|13.3|
91788733|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.2|49.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||49.9|35.2|
91788734|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|58.0|||||TWO_SIDED|95.0|46.6|67.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||67.3|46.6|
91788735|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|33.0|||||TWO_SIDED|95.0|23.0|42.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||42.5|23.0|
91788736|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|13.0|||||TWO_SIDED|95.0|8.8|18.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||18.3|8.8|
91788737|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.6|29.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||29.0|12.6|
91523627|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91609763|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.17|0.48|
91609764|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.58|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.05|0.58|
91710186|NCT02494401|183312841|SUPERIORITY|||||||0.93||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.93
91788738|NCT02446743|183457887|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|8.0|||||TWO_SIDED|95.0|2.7|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||14.7|2.7|
91791134|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791135|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.063|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.063|0.990
91613346|NCT02043301|183121113|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|129.98|||||TWO_SIDED|90.0|106.76|158.27|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||158.27|106.76|
91710187|NCT02494401|183312841|SUPERIORITY|||||||0.54||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.54
91710188|NCT02494401|183312841|SUPERIORITY|||||||0.33||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.33
91710189|NCT02494401|183312842|SUPERIORITY|||||||0.59||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.59
91710190|NCT02494401|183312842|SUPERIORITY|||||||0.25||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.25
91710191|NCT02494401|183312842|SUPERIORITY|||||||0.12||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.12
91791136|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91791137|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.944|TWO_SIDED|95.0|-0.063|0.067||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.067|-0.063|0.944
91791138|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
91609765|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.41|0.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.88|0.41|
91609766|NCT01025336|183112608|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.05|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.81|1.05|
91791139|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.042||0.942|TWO_SIDED|95.0|-0.079|0.085||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.085|-0.079|0.942
91791140|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791141|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.041||0.876|TWO_SIDED|95.0|-0.087|0.074||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.074|-0.087|0.876
91791142|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791143|NCT02880956|183460096|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.043||0.163|TWO_SIDED|95.0|-0.024|0.143||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.143|-0.024|0.163
91791144|NCT02880956|183460096|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
91791145|NCT02081859|183460097|OTHER|||||||0.41|||||||Chi-squared|||||||0.41
91791146|NCT02081859|183460098|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
91791147|NCT03718299|183460101|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Week 52||||<0.001
91791148|NCT03718299|183460102|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
91791149|NCT03718299|183460103|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791150|NCT03718299|183460104|SUPERIORITY||Clopper-Pearson|62.2|||||TWO_SIDED|95.0|46.5|76.2||||||||76.2|46.5|
91791151|NCT03718299|183460105|SUPERIORITY||Clopper-Pearson|93.3|||||TWO_SIDED|95.0|81.7|98.6||||||||98.6|81.7|
91791152|NCT03718299|183460106|SUPERIORITY||Clopper-Pearson|78.9|||||TWO_SIDED|95.0|62.7|90.4||||||||90.4|62.7|
91791153|NCT03718299|183460107|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791154|NCT03718299|183460108|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791155|NCT03718299|183460109|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791156|NCT03718299|183460110|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791157|NCT03718299|183460111|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791158|NCT03718299|183460112|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791159|NCT03718299|183460113|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91791160|NCT03718299|183460114|SUPERIORITY||Mean (Clopper-Pearson)|24.4|||||TWO_SIDED|95.0|12.9|39.5||||||||39.5|12.9|
91791161|NCT03718299|183460115|SUPERIORITY||Mean (Clopper-Pearson)|17.8|||||TWO_SIDED|95.0|8.0|32.1||||||||32.1|8.0|
91791162|NCT03718299|183460116|SUPERIORITY||Clopper-Pearson|48.9|||||TWO_SIDED|95.0|33.7|64.2||||||||64.2|33.7|
91791163|NCT03718299|183460117|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Activity Impairment||||<0.001
91791164|NCT03718299|183460117|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Work Productivity Impairment||||<0.001
91791165|NCT03718299|183460118|SUPERIORITY||Mean|79.5|STANDARD_DEVIATION|20.06|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time- Effectiveness||||
91791166|NCT03718299|183460118|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||Treatment Satisfaction Questionnaire for Medication over time-Side Effects||||<0.001
91791167|NCT03718299|183460118|SUPERIORITY||Mean|82.2|STANDARD_DEVIATION|16.35|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Convenience||||
91791168|NCT03718299|183460118|SUPERIORITY||Mean|81.9|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Global Satisfaction||||
91791169|NCT03718299|183460119|SUPERIORITY||Mean|8.7|STANDARD_DEVIATION|2.01|||TWO_SIDED|||||||||Improvement in Symptoms||||
91791170|NCT03718299|183460119|SUPERIORITY||Mean|8.3|STANDARD_DEVIATION|2.3|||TWO_SIDED|||||||||Speed of Symptom Improvement||||
91791171|NCT03718299|183460119|SUPERIORITY||Mean|9.1|STANDARD_DEVIATION|1.7|||TWO_SIDED|||||||||Frequency of Taking Medication||||
91791172|NCT03718299|183460119|SUPERIORITY||Mean|9.6|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||Side Effects||||
91791173|NCT03718299|183460120|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91788739|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|40.0|||||TWO_SIDED|95.0|33.9|46.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.3|33.9|
91788740|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|49.0|||||TWO_SIDED|95.0|38.9|58.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|38.9|
91788741|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|34.0|||||TWO_SIDED|95.0|26.6|42.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||42.2|26.6|
91788742|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|27.0|||||TWO_SIDED|95.0|21.6|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|21.6|
91788743|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|23.0|||||TWO_SIDED|95.0|15.5|32.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.0|15.5|
91609767|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.27|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|1.27|
91609768|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.95|1.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.59|0.95|
91788744|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|22.9|38.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.1|22.9|
91788745|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.1|50.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.6|35.1|
91523628|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91609769|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.29|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.29|1.03|
91710192|NCT02494401|183312843|SUPERIORITY|||||||0.51||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.51
91710193|NCT02494401|183312843|SUPERIORITY|||||||0.93||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.93
91788746|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|51.0|||||TWO_SIDED|95.0|39.3|60.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||60.9|39.3|
91609770|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.95|1.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.97|0.95|
91609771|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|2.2|||||TWO_SIDED|95.0|1.42|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.31|1.42|
91609772|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.88|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.04|0.88|
91609773|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.95|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|0.95|
91609774|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.7|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.99|0.70|
91609775|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.25|0.57|
91653706|NCT02655237|183200527|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-13.3|||||TWO_SIDED|95.0|-21.418|-5.118|||||Relugolix 40 mg-Leuprorelin|||-5.118|-21.418|
91653707|NCT02655237|183200528|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-12.05|||||TWO_SIDED|95.0|-19.778|-4.33|||||Relugolix 40 mg-Leuprorelin|Week 2||-4.330|-19.778|
91653708|NCT02655237|183200528|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-2.55|||||TWO_SIDED|95.0|-11.916|6.819|||||Relugolix 40 mg-Leuprorelin|Week 4||6.819|-11.916|
91653709|NCT02655237|183200528|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|4.69|||||TWO_SIDED|95.0|-3.141|12.529|||||Relugolix 40 mg-Leuprorelin|Week 8||12.529|-3.141|
91609776|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.06|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.12|1.06|
91609777|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.97|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.69|0.97|
91609778|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.21|2.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.53|1.21|
91609779|NCT01025336|183112609|SUPERIORITY_OR_OTHER||Ratio of GMT|2.3|||||TWO_SIDED|95.0|1.54|3.42|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.42|1.54|
91653710|NCT02655237|183200528|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.59|||||TWO_SIDED|95.0|-3.433|10.605|||||Relugolix 40 mg-Leuprorelin|Week 12||10.605|-3.433|
91653711|NCT02655237|183200528|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.96|||||TWO_SIDED|95.0|-3.319|11.245|||||Relugolix 40 mg-Leuprorelin|Week 24||11.245|-3.319|
91791174|NCT04389970|183460124|OTHER|Single group, within subject pre/post change.||||||0.39|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no conclusion of significance can be made.||||.39
91788747|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|41.0|||||TWO_SIDED|95.0|29.9|50.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.2|29.9|
91788748|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|12.9|24.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||24.6|12.9|
91788749|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|28.0|||||TWO_SIDED|95.0|17.9|37.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.8|17.9|
91788750|NCT02446743|183457888|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|6.4|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.1|6.4|
91788751|NCT02446743|183457889|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.11|3.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.20|2.11|
91609780|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.8|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.63|0.80|
91609781|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.77|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.39|0.77|
91609782|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.69|0.68|
91609783|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.31|1.03|
91609784|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|2.7|||||TWO_SIDED|95.0|1.66|4.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||4.55|1.66|
91609785|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|3.7|||||TWO_SIDED|95.0|2.25|5.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.94|2.25|
91609786|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|6.2|||||TWO_SIDED|95.0|3.85|9.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||9.98|3.85|
91609787|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|2.43|7.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||7.40|2.43|
91609788|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.89|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.13|0.89|
91613347|NCT02043301|183121113|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|100.27|||||TWO_SIDED|90.0|82.54|121.82|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||121.82|82.54|
91710194|NCT02494401|183312843|SUPERIORITY|||||||0.84||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.84
91523629|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91788752|NCT02446743|183457889|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|8.85|15.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||15|8.85|
91523630|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91523631|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91609789|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.06|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.57|1.06|
91609790|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|2.0|||||TWO_SIDED|95.0|1.5|2.78|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.78|1.50|
91609791|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|3.4|||||TWO_SIDED|95.0|2.3|5.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.04|2.30|
91609792|NCT01025336|183112610|SUPERIORITY_OR_OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.37|3.37|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.37|1.37|
91609793|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 1: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.90|0.48|
91653712|NCT02655237|183200529|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-15.15|||||TWO_SIDED|95.0|-20.786|-9.509|||||Relugolix 40 mg-Leuprorelin|Week 2||-9.509|-20.786|
91523632|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91523633|NCT00279201|182923055|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for Week 18.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||0.001
91523634|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91609794|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.64|1.09|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 3: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.09|0.64|
91791175|NCT04389970|183460125|OTHER|Single group, within subject pre/post change.||||||0.3|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.3
91609795|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.3|||||TWO_SIDED|95.0|0.2|0.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 4: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.44|0.20|
91609796|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 5: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.26|0.59|
91653713|NCT02655237|183200529|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-10.27|||||TWO_SIDED|95.0|-17.291|-3.246|||||Relugolix 40 mg-Leuprorelin|Week 4||-3.246|-17.291|
91523635|NCT00279201|182923055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
91523636|NCT00279201|182923056|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91523637|NCT00279201|182923057|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||<0.001
91523638|NCT00279201|182923058|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91523639|NCT00279201|182923059|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use and Sulfo use in model.||||||<0.001
91523640|NCT00279201|182923060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
91523641|NCT00279201|182923061|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91788753|NCT02446743|183457889|OTHER|Vaccine comparison-Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.18|||||TWO_SIDED|95.0|1.7|2.79|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.79|1.70|
91788754|NCT02446743|183457889|OTHER|Vaccine comparison-post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|12.0|||||TWO_SIDED|95.0|8.22|17.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||17|8.22|
91788755|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|3.04|||||TWO_SIDED|95.0|2.2|4.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.20|2.20|
91788756|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|7.75|16.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||16|7.75|
91788757|NCT02446743|183457889|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||21|12|
91788758|NCT02446743|183457889|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|68.0|||||TWO_SIDED|95.0|51.0|90.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||90|51|
91788759|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|18.0|||||TWO_SIDED|95.0|13.0|26.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||26|13|
91788760|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|74.0|||||TWO_SIDED|95.0|51.0|107.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||107|51|
91788761|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|14.0|||||TWO_SIDED|95.0|8.99|22.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||22|8.99|
91791176|NCT04389970|183460126|OTHER|Single group, within subjects pre/post change.||||||0.77|||||||t-test, 2 sided|Paired-sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.77
91609797|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.11|0.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.26|0.11|
91710195|NCT02494401|183312844|SUPERIORITY|||||||0.83||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.83
91791177|NCT04389970|183460127|OTHER|Single group, within subjects pre/post change.||||||0.66|||||||t-test, 2 sided|Paired-samples t-test.||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.66
91791178|NCT04389970|183460128|OTHER|Single group, within subjects pre/post change||||||0.88|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.88
91523642|NCT00279201|182923062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Pre Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91523643|NCT00279201|182923062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Post Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91609798|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.49|1.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6B: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.22|0.49|
91710196|NCT02494401|183312844|SUPERIORITY|||||||0.27||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.27
91791179|NCT04389970|183460129|OTHER|Single group, within subjects pre/post change||||||0.03|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.03
91609799|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.76|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 7F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.76|0.68|
91609800|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.9|2.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 9V: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.55|0.90|
91609801|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.3|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 14: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.30|1.02|
91609802|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.52|1.14|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 18C: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.14|0.52|
91609803|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.62|1.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.08|0.62|
91609804|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.89|1.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.98|0.89|
91653714|NCT02655237|183200529|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.89|||||TWO_SIDED|95.0|-6.996|5.209|||||Relugolix 40 mg-Leuprorelin|Week 8||5.209|-6.996|
91609805|NCT01025336|183112611|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.26|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 23F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.59|0.26|
91609806|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
91609807|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
91653715|NCT02655237|183200529|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.94|||||TWO_SIDED|95.0|-6.964|5.076|||||Relugolix 40 mg-Leuprorelin|Week 12||5.076|-6.964|
91653716|NCT02655237|183200529|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|0.86|||||TWO_SIDED|95.0|-6.206|7.935|||||Relugolix 40 mg-Leuprorelin|Week 24||7.935|-6.206|
91609808|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
91609809|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
91609810|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
91653717|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|0.015|0.381|||||Relugolix 40 mg-Leuprorelin|Week 4||0.381|0.015|
91653718|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-0.135|0.333|||||Relugolix 40 mg-Leuprorelin|Week 8||0.333|-0.135|
91653719|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.189|0.323|||||Relugolix 40 mg-Leuprorelin|Week 12||0.323|-0.189|
91653720|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.01|||||TWO_SIDED|95.0|-0.275|0.251|||||Relugolix 40 mg-Leuprorelin|Week 16||0.251|-0.275|
91609811|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
91609812|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
91653721|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.1|||||TWO_SIDED|95.0|-0.386|0.18|||||Relugolix 40 mg-Leuprorelin|Week 20||0.180|-0.386|
91653722|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.09|||||TWO_SIDED|95.0|-0.385|0.209|||||Relugolix 40 mg-Leuprorelin|Week 24||0.209|-0.385|
91788762|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|63.0|||||TWO_SIDED|95.0|41.0|95.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||95|41|
91788763|NCT02446743|183457889|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.24|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|1.24|
91788764|NCT02446743|183457889|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|5.9|||||TWO_SIDED|95.0|4.49|7.76|||ANOVA|||Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||7.76|4.49|
91653723|NCT02655237|183200530|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.49|||||TWO_SIDED|95.0|-0.787|-0.199|||||Relugolix 40 mg-Leuprorelin|Follow up (up to Week 28)||-0.199|-0.787|
91653724|NCT02655237|183200531|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.032|0.174|||||Relugolix 40 mg-Leuprorelin|Week 6 to 12||0.174|-0.032|
91653725|NCT02655237|183200531|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.05|||||TWO_SIDED|95.0|-0.089|0.197|||||Relugolix 40 mg-Leuprorelin|Week 2 to 6||0.197|-0.089|
91788765|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.13|1.54|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.54|1.13|
91653726|NCT02655237|183200531|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.01|||||TWO_SIDED|95.0|-0.06|0.086|||||Relugolix 40 mg-Leuprorelin|Week 18 to 24||0.086|-0.060|
91653727|NCT02655237|183200531|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.02|||||TWO_SIDED|95.0|-0.063|0.099|||||Relugolix 40 mg-Leuprorelin|For 6 Weeks Before the Final Dose (up to Week 24)||0.099|-0.063|
91653728|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-2.5|||||TWO_SIDED|95.0|-6.39|1.43|||||Relugolix 40 mg-Leuprorelin|Week 4||1.43|-6.39|
91653729|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-4.0|||||TWO_SIDED|95.0|-6.68|-1.31|||||Relugolix 40 mg-Leuprorelin|Week 8||-1.31|-6.68|
91653730|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|-1.99|2.36|||||Relugolix 40 mg-Leuprorelin|Week 12||2.36|-1.99|
91653731|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|1.3|||||TWO_SIDED|95.0|-0.68|3.28|||||Relugolix 40 mg-Leuprorelin|Week 16||3.28|-0.68|
91653732|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-1.8|2.32|||||Relugolix 40 mg-Leuprorelin|Week 20||2.32|-1.80|
91710197|NCT02494401|183312844|SUPERIORITY|||||||0.18||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.18
91653733|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.5|||||TWO_SIDED|95.0|-1.48|2.52|||||Relugolix 40 mg-Leuprorelin|Week 24||2.52|-1.48|
91653734|NCT02655237|183200532|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|3.4|||||TWO_SIDED|95.0|1.08|5.77|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||5.77|1.08|
91653735|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.3|||||TWO_SIDED|95.0|-1.66|6.34|||||Relugolix 40 mg-Leuprorelin|Week 4||6.34|-1.66|
91653736|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.7|||||TWO_SIDED|95.0|-0.37|5.77|||||Relugolix 40 mg-Leuprorelin|Week 8||5.77|-0.37|
91653737|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.9|||||TWO_SIDED|95.0|-1.84|3.61|||||Relugolix 40 mg-Leuprorelin|Week 12||3.61|-1.84|
91653738|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-2.61|2.79|||||Relugolix 40 mg-Leuprorelin|Week 16||2.79|-2.61|
91653739|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.8|||||TWO_SIDED|95.0|-1.74|3.41|||||Relugolix 40 mg-Leuprorelin|Week 20||3.41|-1.74|
91710198|NCT02494401|183312845|SUPERIORITY|||||||0.64||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.64
91653740|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-2.07|2.71|||||Relugolix 40 mg-Leuprorelin|Week 24||2.71|-2.07|
91653741|NCT02655237|183200533|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-1.4|||||TWO_SIDED|95.0|-3.96|1.09|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||1.09|-3.96|
91653742|NCT03748641|183200581|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0217|TWO_SIDED|95.0|0.556|0.956|||Log Rank|||||0.956|0.556|0.0217
91653743|NCT03748641|183200582|SUPERIORITY||Hazard Ratio (HR)|0.533||||0.0014|TWO_SIDED|95.0|0.361|0.789|||Log Rank|||||0.789|0.361|0.0014
91653744|NCT00926289|183200607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001||95.0|-10.6|-6.4|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-6.4|-10.6|<0.0001
91653745|NCT00926289|183200608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.0001||95.0|-9.3|-5.2|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-5.2|-9.3|<0.0001
91653746|NCT00926289|183200609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.0001||95.0|-8.8|-4.7|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-4.7|-8.8|<0.0001
91653747|NCT00926289|183200610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001||95.0|-4.5|-1.9|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-1.9|-4.5|<0.0001
91653748|NCT00926289|183200611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.0001||95.0|1.74|3.21|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.21|1.74|<0.0001
91791180|NCT04389970|183460130|OTHER|Single group, within subjects pre/post change.||||||0.06|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.06
91653749|NCT00926289|183200612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001||95.0|1.7|3.12|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.12|1.70|<0.0001
91653750|NCT00926289|183200613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.0001||95.0|1.6|3.01|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.01|1.60|<0.0001
91710199|NCT02494401|183312845|SUPERIORITY|||||||0.8||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.8
91710200|NCT02494401|183312845|SUPERIORITY|||||||0.09||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.09
91710201|NCT02494401|183312846|SUPERIORITY|||||||0.73||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.73
91710202|NCT02494401|183312846|SUPERIORITY|||||||0.82||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.82
91710203|NCT02494401|183312846|SUPERIORITY|||||||0.04||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.04
91710204|NCT02494401|183312847|SUPERIORITY|||||||0.95||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.95
91791181|NCT04389970|183460131|OTHER|Single group, within subjects pre/post change||||||0.04|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.04
91791182|NCT04389970|183460132|OTHER|Single group, within subjects analysis.||||||0|||||||t-test, 2 sided|Paired sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||0
91653751|NCT00926289|183200614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001||95.0|1.46|2.73|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.73|1.46|<0.0001
91653752|NCT00926289|183200615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02|||<|0.0001||95.0|1.48|2.76|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.76|1.48|<0.0001
91653753|NCT00926289|183200616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.0005||95.0|1.28|2.37|||Regression, Logistic|Adjustment for continuous covariate of baseline and fixed effect country||T80+HCTZ25 versus T80 monotherapy||2.37|1.28|0.0005
91653754|NCT00926289|183200617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001||95.0|1.76|3.26|||Regression, Logistic|Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.26|1.76|<0.0001
91653755|NCT00926289|183200618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.0001||95.0|1.78|3.29|||Regression, Logistic|Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.29|1.78|<0.0001
91653756|NCT00926289|183200619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001||95.0|1.7|4.04|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||4.04|1.70|<0.0001
91653757|NCT00926289|183200620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.0001||95.0|1.57|3.16|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.16|1.57|<0.0001
91653758|NCT00926289|183200621|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren test stratified for country|||T80+HCTZ25 versus T80 monotherapy||||<0.0001
91653759|NCT01199601|183200629|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.12|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.23|||Regression, Linear|Information provided for crude analysis results; adjustment for significant baseline differences between groups did not change results substantially.||Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||1.23|1.02|<0.05
91653760|NCT01199601|183200630|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.1|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.18|||Regression, Linear|Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||||1.18|1.02|<0.05
91653761|NCT01199601|183200631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|1.01|1.25|||Regression, Logistic|The crude analysis result is provided as the odds ratio did not change substantially when adjusted for possible confounders.||||1.25|1.01|0.05
91653762|NCT02292238|183200642|OTHER||Mean Difference (Net)|1.8691|STANDARD_DEVIATION|5.5727||0.125|TWO_SIDED|||||Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||Power was calculated based on expected difference in change on the ADAS-Cog of 3 points between the treatment and control groups. Estimates based on using a two-sided alpha of 0.05 and a standard deviation of 4, enrolling 29 patients per group, (N = 58) suggest 80% power to detect a mean change of 3 between treatment and placebo.||||0.125
91653763|NCT02292238|183200643|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-0.00184|STANDARD_DEVIATION|0.0225||0.7529|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.7529
91653764|NCT02292238|183200644|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.0636|STANDARD_DEVIATION|4.8176||0.3687|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.3687
91653765|NCT02292238|183200645|OTHER||Mean Difference (Net)|1.8203|STANDARD_DEVIATION|13.8988||0.485|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.4850
91653766|NCT02292238|183200646|OTHER||Mean Difference (Net)|0.1907|STANDARD_DEVIATION|0.3097||0.0337|TWO_SIDED|||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||||||0.0337
91653767|NCT02292238|183200647|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.6161|STANDARD_DEVIATION|5.6812||0.315|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.315
91653768|NCT00491504|183200672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||ANCOVA|An analysis of covariance (ANCOVA) model was used with treatment as effect and Baseline as a covariate.||||||0.625
91653769|NCT02041702|183200679|SUPERIORITY|The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.|Ratio|100.0|||<|0.01|TWO_SIDED|90.0|97.6|100.0|||Clopper-Pearson|Clopper-Pearson CI for the binomial proportion|The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.|The hypothesis was: H0: P≤ 90% vs H1: P\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group||100|97.6|<0.01
91710205|NCT02494401|183312847|SUPERIORITY|||||||0.87||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.87
91523644|NCT00279201|182923062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Average of All Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91523645|NCT00279201|182923062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Fasting Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
91710206|NCT02494401|183312847|SUPERIORITY|||||||0.63||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.63
91609813|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
91609814|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
91609815|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
91609816|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
91609817|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
91609818|NCT01025336|183112612|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
91609819|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.92|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 1: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.92|0.48|
91710207|NCT02494401|183312848|SUPERIORITY|||||||0.05||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.05
91710208|NCT02494401|183312848|SUPERIORITY|||||||0.62||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.62
91609820|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.76|1.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 3: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.28|0.76|
91609821|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.88|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 4: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.22|0.88|
91613348|NCT02043301|183121118|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.35|||||TWO_SIDED|90.0|84.659|111.943|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||111.943|84.659|
91613349|NCT02043301|183121118|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|103.96|||||TWO_SIDED|90.0|90.405|119.557|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||119.557|90.405|
91613350|NCT02043301|183121119|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
91613351|NCT02043301|183121119|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
91613352|NCT02043301|183121120|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
91613353|NCT02043301|183121120|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
91613354|NCT02043301|183121122|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.51|||||TWO_SIDED|90.0|97.555|107.717|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.717|97.555|
91613355|NCT02043301|183121122|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.02|||||TWO_SIDED|90.0|97.131|107.151|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.151|97.131|
91609822|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|1.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 5: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.95|0.93|
91609823|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.27|0.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.66|0.27|
91609824|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6B: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.56|0.64|
91609825|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.14|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 7F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.04|1.14|
91609826|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.01|2.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 9V: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.85|1.01|
91653770|NCT02041702|183200680|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-0.9||||0.0007|TWO_SIDED|90.0|-5.6|3.8|||Farrington-Manning Test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\>-10%~* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit"||3.8|-5.6|0.0007
91653771|NCT02041702|183200681|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-1.7||||0.0012|TWO_SIDED|90.0|-6.2|2.8|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||2.8|-6.2|0.0012
91653772|NCT02041702|183200682|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-2.7||||0.0446|TWO_SIDED|90.0|-9.8|4.3|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||4.3|-9.8|0.0446
91609827|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.26|2.87|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 14: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.87|1.26|
91609828|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.19|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 18C: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.19|0.57|
91609829|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.75|1.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.31|0.75|
91609830|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.04|0.93|
91609831|NCT01025336|183112613|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 23F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.15|0.50|
91609832|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
91609833|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
91609834|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
91653773|NCT02041702|183200683|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|2.6||||0.0002|TWO_SIDED|90.0|-3.2|8.4|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||8.4|-3.2|0.0002
91710209|NCT02494401|183312848|SUPERIORITY|||||||0.7||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.7
91710210|NCT02494401|183312849|SUPERIORITY|||||||0.29||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.29
91788766|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|8.27|||||TWO_SIDED|95.0|5.83|12.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||12|5.83|
91523646|NCT00279201|182923063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Sulfonylurea/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
91609835|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
91609836|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
91609837|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
91609838|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
91609839|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
91653774|NCT02308111|183200693|SUPERIORITY||Hazard Ratio, log|1.01||||0.954|TWO_SIDED|95.0|0.68|1.51||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata|Log Rank|||||1.51|0.68|0.954
91653775|NCT02308111|183200694|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.304|TWO_SIDED|95.0|0.61|1.16||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.16|0.61|0.304
91653776|NCT02308111|183200695|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.898|TWO_SIDED|95.0|0.69|1.52||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.52|0.69|0.898
91609840|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
91609841|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
91609842|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
91609843|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
91609844|NCT01025336|183112614|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
91609845|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.64|0.87|
91609846|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.63|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.08|0.63|
91609847|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.25|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.80|1.25|
91653777|NCT02308111|183200696|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.91|0.69|0.594
91653778|NCT02308111|183200697|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.568|TWO_SIDED|95.0|0.57|2.78||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||2.78|0.57|0.568
91653779|NCT02308111|183200698|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.769|TWO_SIDED|95.0|0.59|2.07||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata.|Gray's Test|||||2.07|0.59|0.769
91653780|NCT02308111|183200699|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.599|TWO_SIDED|95.0|0.42|1.67||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.67|0.42|0.599
91788767|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.64|||||TWO_SIDED|95.0|1.22|2.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.20|1.22|
91609848|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.71|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.53|0.71|
91609849|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|7.3|||||TWO_SIDED|95.0|4.67|11.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||11.44|4.67|
91609850|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|2.6|||||TWO_SIDED|95.0|1.61|4.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.17|1.61|
91609851|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|2.0|||||TWO_SIDED|95.0|1.22|3.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||3.29|1.22|
91609852|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|0.96|2.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.77|0.96|
91609853|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.28|0.54|
91710211|NCT02494401|183312849|SUPERIORITY|||||||0.58||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.58
91788768|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|4.36|||||TWO_SIDED|95.0|2.88|6.58|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||6.58|2.88|
91788769|NCT02446743|183457889|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.3|||||TWO_SIDED|95.0|0.97|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|0.97|
91609854|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.07|0.92|
91609855|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.83|1.01|
91609856|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.77|1.78|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.78|0.77|
91609857|NCT01025336|183112615|SUPERIORITY_OR_OTHER||Ratio|3.0|||||TWO_SIDED|95.0|1.97|4.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.64|1.97|
91653781|NCT02308111|183200700|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.745|TWO_SIDED|95.0|0.18|3.43||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.43|0.18|0.745
91653782|NCT02308111|183200701|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.437|TWO_SIDED|95.0|0.43|1.44||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.44|0.43|0.437
91653783|NCT02308111|183200702|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.838|TWO_SIDED|95.0|0.37|2.24||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||2.24|0.37|0.838
91653784|NCT02308111|183200703|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.26|4.04||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||4.04|0.26|0.980
91788770|NCT02446743|183457889|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.08|3.25|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.25|2.08|
91788771|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.9|2.18|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.18|0.90|
91609858|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.15|2.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.15|1.15|
91609859|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.32|0.76|
91609860|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.09|3.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.05|1.09|
91653785|NCT02308111|183200704|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.933|TWO_SIDED|95.0|0.58|1.83||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.83|0.58|0.933
91653786|NCT02308111|183200705|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.468|TWO_SIDED|95.0|0.53|1.34||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.34|0.53|0.468
91653787|NCT02308111|183200706|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.178|TWO_SIDED|95.0|0.13|1.41||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.41|0.13|0.178
91609861|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.95|1.96|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.96|0.95|
91609862|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|4.8|||||TWO_SIDED|95.0|3.05|7.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||7.50|3.05|
91609863|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|2.3|||||TWO_SIDED|95.0|1.4|3.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.64|1.40|
91609864|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.58|1.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.62|0.58|
91609865|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.83|2.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.32|0.83|
91609866|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.40|0.58|
91609867|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.09|2.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.41|1.09|
91609868|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.1|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.03|1.10|
91653788|NCT02308111|183200706|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.19|TWO_SIDED|95.0|0.13|1.41|||Cochran-Mantel-Haenszel|||||1.41|0.13|0.190
91609869|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.3|||||TWO_SIDED|95.0|0.89|2.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.02|0.89|
91609870|NCT01025336|183112616|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.27|2.97|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.97|1.27|
91609871|NCT02723630|183112648|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|100.52||||0.8826|TWO_SIDED|90.0|94.84|106.53||P-value for the formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.53|94.84|0.8826
91609872|NCT02723630|183112648|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.03||||0.1095|TWO_SIDED|90.0|92.11|100.12||P-value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.12|92.11|0.1095
91609873|NCT02723630|183112649|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.8||||0.8121|TWO_SIDED|90.0|95.31|106.61||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.61|95.31|0.8121
91653789|NCT02308111|183200707|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.443|TWO_SIDED|95.0|0.05|3.54||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.54|0.05|0.443
91653790|NCT03977584|183200860|SUPERIORITY||Difference in Annualized Rate of Change|-0.013|STANDARD_ERROR_OF_MEAN|0.00993||0.1953|TWO_SIDED|95.0|-0.0327|0.0068|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: GTP1 PET = Treatment \* Analysis Year + Interactive Voice or Web Response System (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein (APOE4) Carrier Status + IxRS defined Clinical Dementia Rating Global Score.||0.0068|-0.0327|0.1953
91710212|NCT02494401|183312849|SUPERIORITY|||||||0.49||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.49
91788772|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.79|||||TWO_SIDED|95.0|2.04|3.81|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.81|2.04|
91609874|NCT02723630|183112649|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.51||||0.163|TWO_SIDED|90.0|92.53|100.65||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.65|92.53|0.1630
91523647|NCT00279201|182923063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for TZD/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
91613356|NCT02043301|183121123|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
91613357|NCT02043301|183121123|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
91613358|NCT02043301|183121124|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
91613359|NCT02043301|183121124|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
91613360|NCT03703375|183121130|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0541|TWO_SIDED|95.0|0.41|1.09|||Stratified Cox|Stratified Cox proportional hazards model||||1.09|0.41|0.0541
91613361|NCT03703375|183121131|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0166|TWO_SIDED|95.0|0.32|0.96|||Efron|Stratified Cox proportional hazards model||||0.96|0.32|0.0166
91613362|NCT03703375|183121132|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2139|TWO_SIDED|95.0|0.51|1.33|||Stratified Cox|Stratified Cox proportional hazards model||||1.33|0.51|0.2139
91613363|NCT01703286|183121144|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5403|TWO_SIDED|90.0|0.633|1.235|||ANOVA|||||1.235|0.633|0.5403
91613364|NCT01703286|183121144|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5402|TWO_SIDED|90.0|0.632|1.235|||ANOVA|||||1.235|0.632|0.5402
91613365|NCT01703286|183121144|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.0||||0.9989|TWO_SIDED|90.0|0.715|1.397|||ANOVA|||||1.397|0.715|0.9989
91613366|NCT01703286|183121145|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.208||||0.3885|TWO_SIDED|90.0|0.84|1.738|||ANOVA|||||1.738|0.840|0.3885
91613367|NCT01703286|183121145|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.251||||0.3105|TWO_SIDED|90.0|0.868|1.801|||ANOVA|||||1.801|0.868|0.3105
91613368|NCT01703286|183121145|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.035||||0.8749|TWO_SIDED|90.0|0.721|1.485|||ANOVA|||||1.485|0.721|0.8749
91613369|NCT01703286|183121146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.048||0.2982|TWO_SIDED|90.0|-0.13|0.03|||ANOVA|||||0.030|-0.130|0.2982
91613370|NCT01703286|183121146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.048||0.6601|TWO_SIDED|90.0|-0.059|0.101|||ANOVA|||||0.101|-0.059|0.6601
91613371|NCT01703286|183121146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.048||0.1412|TWO_SIDED|90.0|-0.009|0.152|||ANOVA|||||0.152|-0.009|0.1412
91613372|NCT00931892|183121148|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
91613373|NCT00931892|183121149|OTHER|||||||0.409|||||||t-test, 2 sided|||||||0.409
91613374|NCT00931892|183121150|OTHER|||||||0.387|||||||t-test, 2 sided|||||||0.387
91613375|NCT00931892|183121150|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
91613376|NCT00931892|183121151|SUPERIORITY|||||||0.01|||||||ANOVA|||P Value for IgA anti-tTG||||0.010
91613377|NCT00931892|183121151|SUPERIORITY|||||||0.036|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.036
91613378|NCT00931892|183121151|SUPERIORITY|||||||0.013|||||||ANOVA|||P Value for IgA anti-tTG||||0.013
91613379|NCT00931892|183121151|SUPERIORITY|||||||0.006|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.006
91613380|NCT00931892|183121153|OTHER|||||||0.05|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) score for Day 3 of Gluten Challenge||||0.05
91613381|NCT00931892|183121153|OTHER|||||||0.02|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) Score from baseline to Day 14||||0.020
91613382|NCT00931892|183121153|SUPERIORITY|||||||0.06|||||||ANOVA|||P Value for Celiac Symptom Index (CSI)score between high gluten group and low gluten group across study||||0.060
91609875|NCT02723630|183112650|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|99.68||||0.9427|TWO_SIDED|90.0|92.45|107.47||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||107.47|92.45|0.9427
91609876|NCT02723630|183112650|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|93.5||||0.0403|TWO_SIDED|90.0|88.63|98.64||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.64|88.63|0.0403
91609877|NCT02723630|183112651|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.29||||0.9373|TWO_SIDED|90.0|94.37|106.58||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.58|94.37|0.9373
91609878|NCT02723630|183112651|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|95.17||||0.0682|TWO_SIDED|90.0|91.03|99.5||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||99.50|91.03|0.0682
91609879|NCT02723630|183112652|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|98.73||||0.8448|TWO_SIDED|90.0|88.57|110.06||P value for formulation|Mixed Models Analysis||Geometric Least Squares Mean Ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||110.06|88.57|0.8448
91609880|NCT02723630|183112652|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|90.64||||0.0498|TWO_SIDED|90.0|83.51|98.38||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.38|83.51|0.0498
91609881|NCT02255838|183112656|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|paired t-test||||||<0.05
91609882|NCT04207710|183112660|SUPERIORITY|||||||0.317||||||A priori threshold for significance was p\<0.05.|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
91710213|NCT02494401|183312850|SUPERIORITY|||||||0.87||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.87
91523648|NCT00279201|182923063|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.969
91609883|NCT04207710|183112660|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
91609884|NCT04207710|183112660|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
91609885|NCT04207710|183112660|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
91609886|NCT01515072|183112661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.38|TWO_SIDED|95.0|-0.37|0.21||This is an unadjusted comparison. P value \< 0.05|t-test, 2 sided|Adjusted analyses for the RIPC effect are provided below.|0.08 less organs per donor in the RIPC group.|Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.21|-0.37|0.38
91613383|NCT00931892|183121155|OTHER|||||||0.01|||||||t-test, 2 sided|||P Value for the Gastrointestinal Symptom Rating Scale (GSRS) on Day 3 of the Gluten Challenge||||0.01
91613384|NCT00931892|183121155|OTHER|||||||0.012|||||||t-test, 2 sided|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) from baseline to Day 14 of Gluten Challenge||||0.012
91613385|NCT00931892|183121155|SUPERIORITY|||||||0.09|||||||ANOVA|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) between high gluten group and low gluten group across study||||0.090
91613386|NCT00719576|183121177|SUPERIORITY|The Wilks lambda test statistic and associated single P value from the MANOVA model were used to test the statistical significance of the difference in the co-primary endpoint between MACI and microfracture.||||||0.001|||||||MANOVA|||The changes from Baseline to Week 104 in KOOS Pain and Function (SRA) scores (co-primary efficacy parameter) were analyzed with a multivariate analysis of variance (MANOVA) model, with the last observation carried forward (LOCF) method for handling missing data. Terms included in the model are treatment and center as class variables and baseline KOOS pain and Function (SRA) as continuous covariates.||||0.001
91609887|NCT01515072|183112662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.33|0.26||This is an unadjusted analysis. P \< 0.05|t-test, 2 sided|Adjusted analyses are provided below.|0.03 less organs per donor in the RIPC group.|Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.26|-0.33|0.70
91609888|NCT01515072|183112663|SUPERIORITY_OR_OTHER|||||||0.63||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.63
91609889|NCT01515072|183112664|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
91609890|NCT01515072|183112665|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
91609891|NCT01515072|183112666|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
91609892|NCT01515072|183112667|SUPERIORITY_OR_OTHER|||||||0.48||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.48
91653791|NCT00745251|183200881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.86|STANDARD_ERROR_OF_MEAN|5.95||0.0084|ONE_SIDED|95.0||-4.84|||ANCOVA|||||-4.84||0.0084
91653792|NCT00745251|183200882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.05|STANDARD_ERROR_OF_MEAN|1.64||0.0006|TWO_SIDED|95.0|-9.37|-2.74|||ANCOVA|||||-2.74|-9.37|0.0006
91653793|NCT03390504|183200883|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0031|TWO_SIDED|95.0|0.48|0.86|||Log Rank|||||0.86|0.48|=0.0031
91653794|NCT03390504|183200883|SUPERIORITY||Hazard Ratio (HR)|1.16|||=|0.2121|TWO_SIDED|95.0|0.92|1.48|||Stratified log-rank test|||||1.48|0.92|=0.2121
91653795|NCT03482713|183200995|OTHER||Difference in least squares means|0.79|||||TWO_SIDED|95.0|-0.34|1.93|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.93|-0.34|
91609893|NCT01515072|183112668|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.04
91609894|NCT01515072|183112669|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.7||||0.53|TWO_SIDED|95.0|-10.1|19.5||P\<0.05|Regression, Linear|Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion|Data shown above is the the adjusted mean difference in final flow in RIPC group|||19.5|-10.1|0.53
91609895|NCT01515072|183112670|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91609896|NCT01515072|183112671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.07|TWO_SIDED|95.0|0.95|2.76||Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.|Chi-squared|||||2.76|0.95|0.07
91609897|NCT01515072|183112671|SUPERIORITY_OR_OTHER|||||||0.36||||||Unadjusted analysis|Chi-squared|||||||0.36
91609898|NCT01515072|183112672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.006|TWO_SIDED|95.0|0.03|0.17|||Regression, Linear|Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.|Data shown above is the adjusted mean difference in final resistance in the RIPC group.|||0.17|0.03|0.006
91609899|NCT01515072|183112673|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|This is an unadjusted comparison||||||0.50
91609900|NCT01515072|183112674|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|This is an unadjusted comparison||||||0.03
91609901|NCT01515072|183112675|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.19||||0.01|TWO_SIDED|95.0|0.04|0.9|||Log Rank|Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below|The proportional hazard ratio favors RIPC group|||0.90|0.04|0.01
91609902|NCT01515072|183112676|SUPERIORITY_OR_OTHER|||||||0.37|||||||Log Rank|This is an unadjusted comparison||||||0.37
91609903|NCT00923091|183112677|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
91609904|NCT00923091|183112677|SUPERIORITY_OR_OTHER|||||||0.0323||95.0|||||ANCOVA|||||||0.0323
91609905|NCT00923091|183112677|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||||||0.0080
91609906|NCT00923091|183112677|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
91609907|NCT00923091|183112677|SUPERIORITY_OR_OTHER|||||||0.0107||95.0|||||ANCOVA|||||||0.0107
91609908|NCT00923091|183112678|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
91609909|NCT00923091|183112678|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
91653796|NCT03482713|183200996|OTHER||Difference least squares mean|0.76|||||TWO_SIDED|95.0|-0.35|1.88|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.88|-0.35|
91653797|NCT03626857|183200997|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||.025
91653798|NCT03626857|183200998|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||0.025
91609910|NCT00923091|183112678|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91609911|NCT00923091|183112678|SUPERIORITY_OR_OTHER|||||||0.0034||95.0|||||ANCOVA|||||||0.0034
91609912|NCT00923091|183112678|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
91653799|NCT02192905|183201025|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 8.|Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|8.31||0.63|TWO_SIDED|95.0|-3.34|2.05|||t-test, 2 sided|||||2.05|-3.34|.63
91653800|NCT02192905|183201026|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 8.|Mean Difference (Final Values)|-0.019|STANDARD_DEVIATION|0.03|<|0.001|TWO_SIDED|95.0|-0.0285|-0.0096|||t-test, 2 sided|||||-.0096|-.0285|<0.001
91653801|NCT02192905|183201027|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 16.|Mean Difference (Final Values)|-0.017|STANDARD_DEVIATION|0.011||0.143|TWO_SIDED|95.0|-0.039|0.006|||t-test, 2 sided|||||.006|-.039|0.143
91653802|NCT02192905|183201028|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 16.|Mean Difference (Final Values)|-0.76|STANDARD_DEVIATION|13.07||0.73|TWO_SIDED|95.0|-5.11|3.6|||t-test, 2 sided|||||3.6|-5.11|.73
91788773|NCT02446743|183457889|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|0.82|1.82|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.82|0.82|
91788774|NCT02446743|183457889|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|2.45|||||TWO_SIDED|95.0|1.79|3.36|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.79|
91523649|NCT00279201|182923063|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value is for Patients with 3 drugs (Sulfonylurea/TZD/Metformin).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.225
91609913|NCT00923091|183112679|SUPERIORITY_OR_OTHER|||||||0.0295||95.0|||||Cochran-Mantel-Haenszel|||||||0.0295
91609914|NCT00923091|183112679|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
91609915|NCT00923091|183112679|SUPERIORITY_OR_OTHER|||||||0.0037||95.0|||||Cochran-Mantel-Haenszel|||||||0.0037
91609916|NCT00923091|183112679|SUPERIORITY_OR_OTHER|||||||0.2033||95.0|||||Cochran-Mantel-Haenszel|||||||0.2033
91609917|NCT00923091|183112679|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
91609918|NCT00923091|183112680|SUPERIORITY_OR_OTHER|||||||0.1135||95.0|||||ANCOVA|||||||0.1135
91609919|NCT00923091|183112681|SUPERIORITY_OR_OTHER|||||||0.2765||95.0|||||ANCOVA|||||||0.2765
91710214|NCT02494401|183312850|SUPERIORITY|||||||0.89||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.89
91710215|NCT02494401|183312850|SUPERIORITY|||||||0.82||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.82
91609920|NCT00923091|183112682|SUPERIORITY_OR_OTHER|||||||0.4964||95.0|||||Cochran-Mantel-Haenszel|||||||0.4964
91609921|NCT00923091|183112683|SUPERIORITY_OR_OTHER|||||||0.1301||95.0|||||ANCOVA|||||||0.1301
91609922|NCT00923091|183112683|SUPERIORITY_OR_OTHER|||||||0.01301||95.0|||||ANCOVA|||||||0.01301
91609923|NCT00923091|183112684|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||ANCOVA|||||||0.0503
91609924|NCT00754390|183112728|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption||||0.17
91609925|NCT00754390|183112728|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption||||0.0002
91609926|NCT00754390|183112728|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.||||0.09
91609927|NCT00847613|183112729|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|36.48|||<|0.0001|TWO_SIDED|95.0|27.73|45.23||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||45.23|27.73|<0.0001
91609928|NCT00847613|183112729|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|26.13|||<|0.0001|TWO_SIDED|95.0|17.28|34.97||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||34.97|17.28|<0.0001
91609929|NCT00847613|183112730|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0376|TWO_SIDED|95.0|-0.79|-0.02||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||-0.02|-0.79|0.0376
91609930|NCT00847613|183112730|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0792|TWO_SIDED|95.0|-0.73|0.04||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||0.04|-0.73|0.0792
91609931|NCT00847613|183112731|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.49|-0.31||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in mTSS had to be significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.31|-0.49|<0.0001
91613387|NCT00719576|183121178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Differences between groups were tested using analysis of variance|ANOVA|ANOVA with terms for treatment and center||||||.717
91613388|NCT00719576|183121179|SUPERIORITY|||||||0.92|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Row Mean Score Chi-Square||Differences between groups were tested by the Cochran-Mantel-Haenszel row mean score chi-squared test for defect fill.||||.920
91609932|NCT00847613|183112731|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05||0.0002|TWO_SIDED|95.0|-0.34|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in mTSS had to be statistically significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.16|-0.34|0.0002
91609933|NCT00847613|183112732|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|14.4|||<|0.0001|TWO_SIDED|95.0|9.44|19.36||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||19.36|9.44|<0.0001
91609934|NCT00847613|183112732|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|5.61||||0.0034|TWO_SIDED|95.0|1.85|9.38||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||9.38|1.85|0.0034
91609935|NCT01933672|183112820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.24|||||TWO_SIDED|80.0|-36.35|-26.12||||||Change from baseline||-26.12|-36.35|
91609936|NCT01933672|183112820|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-31.33|||||TWO_SIDED|80.0|-37.29|-25.37||||||Change from baseline||-25.37|-37.29|
91788775|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.7|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|20.7|
91523650|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Week 0.|ANOVA|ANCOVA used with treatment, country, TZD use, and sulfo use in the model.||||||0.204
91609937|NCT01933672|183112820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.24|||||TWO_SIDED|80.0|-24.99|-13.5||||||Change from baseline||-13.50|-24.99|
91609938|NCT01933672|183112820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
91609939|NCT01933672|183112820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
91609940|NCT01933672|183112821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.92|||||TWO_SIDED|80.0|-27.0|-16.85||||||Compared with Baseline||-16.85|-27.00|
91609941|NCT01933672|183112821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|80.0|-26.3|-15.1||||||Compared with Baseline||-15.10|-26.30|
91609942|NCT01933672|183112821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.51|||||TWO_SIDED|80.0|-22.24|-10.78||||||Compared with Baseline||-10.78|-22.24|
91710216|NCT00803712|183312871|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).||||<0.0001
91788776|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|29.0|||||TWO_SIDED|95.0|19.3|38.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.7|19.3|
91788777|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|26.0|||||TWO_SIDED|95.0|18.3|33.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.9|18.3|
91788778|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|15.9|27.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen||27.9|15.9|
91788779|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|19.0|||||TWO_SIDED|95.0|11.5|28.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.5|11.5|
91788780|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.6|31.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.9|14.6|
91788781|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|38.0|||||TWO_SIDED|95.0|29.8|45.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.4|29.8|
91609943|NCT01933672|183112821|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.41|||||TWO_SIDED|80.0|-11.74|0.92||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||0.92|-11.74|
91609944|NCT01933672|183112821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|80.0|-10.86|2.49||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||2.49|-10.86|
91609945|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|80.0|-0.19|0.07||||||Compared with Baseline （Pre-breakfast）||0.07|-0.19|
91609946|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.09|0.21||||||Compared with Baseline (Pre-breakfast)||0.21|-0.09|
91609947|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|0.16|0.45||||||Compared with Baseline (Pre-breakfast)||0.45|0.16|
91609948|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|80.0|-0.56|-0.36||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.36|-0.56|
91609949|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|80.0|-0.45|-0.03||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.03|-0.45|
91609950|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|80.0|-0.08|0.48||||||Compared with Baseline (Pre-lunch)||0.48|-0.08|
91609951|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|80.0|0.38|1.03||||||Compared with Baseline (Pre-lunch)||1.03|0.38|
91788782|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|55.0|||||TWO_SIDED|95.0|43.5|64.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||64.7|43.5|
91609952|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.26|0.37||||||Compared with Baseline (Pre-lunch)||0.37|-0.26|
91609953|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||||80.0|-0.28|0.57||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.57|-0.28|
91609954|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|80.0|0.19|1.11||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||1.11|0.19|
91609955|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|80.0|0.03|0.68||||||Compared with Baseline (Pre-dinner)||0.68|0.03|
91609956|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|-0.08|0.67||||||Compared with Baseline (Pre-dinner)||0.67|-0.08|
91609957|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|80.0|-0.05|0.68||||||Compared with Baseline (Pre-dinner)||0.68|-0.05|
91609958|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|80.0|-0.45|0.53||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.53|-0.45|
91609959|NCT01933672|183112822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|80.0|-0.55|0.51||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.51|-0.55|
91609960|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|||||TWO_SIDED|80.0|-0.75|1.07||||||Compared with Baseline （Pre-breakfast）||1.07|-0.75|
91609961|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|80.0|-0.58|1.51||||||Compared with Baseline (Pre-breakfast)||1.51|-0.58|
91609962|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|80.0|0.58|2.63||||||Compared with Baseline (Pre-breakfast)||2.63|0.58|
91609963|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|80.0|-2.84|-0.05||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.05|-2.84|
91609964|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.14|||||TWO_SIDED|80.0|-2.63|0.35||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.35|-2.63|
91609965|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||||TWO_SIDED|80.0|-0.5|3.88||||||Compared with Baseline (Pre-lunch)||3.88|-0.50|
91609966|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||||TWO_SIDED|80.0|1.56|6.58||||||Compared with Baseline (Pre-lunch)||6.58|1.56|
91609967|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|80.0|-2.42|2.4||||||Compared with Baseline (Pre-lunch)||2.40|-2.42|
91653803|NCT02396381|183201049|OTHER||LS Mean Difference|3.09|||<|0.001|TWO_SIDED|96.875|1.1|5.09|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of HDL-C for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||5.09|1.10|<0.001
91653804|NCT02396381|183201050|SUPERIORITY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|96.875|-0.717|-0.123|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of WBC for THS-use is lower than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≥ 0.0~HA: XTHS - XCC \< 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||-0.123|-0.717|0.001
91653805|NCT02396381|183201051|SUPERIORITY||LS Mean Difference|1.28||||0.008|TWO_SIDED|96.875|0.145|2.42|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of FEV1 for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||2.42|0.145|0.008
91523651|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Week 12.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.004
91653806|NCT02396381|183201052|SUPERIORITY||% Reduction|2.86||||0.03|TWO_SIDED|96.875|-0.426|6.04|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of sICAM-1 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||6.04|-0.426|0.030
91609968|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|80.0|-1.62|5.01||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.01|-1.62|
91609969|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|80.0|0.54|7.62||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||7.62|0.54|
91609970|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|80.0|-3.66|2.27||||||Compared with Baseline (Pre-dinner)||2.27|-3.66|
91609971|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|80.0|1.7|8.43||||||Compared with Baseline (Pre-dinner)||8.43|1.70|
91609972|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||||TWO_SIDED|80.0|-0.1|6.94||||||Compared with Baseline (Pre-dinner)||6.94|-0.10|
91653807|NCT02396381|183201053|SUPERIORITY||% Reduction|4.74||||0.193|TWO_SIDED|96.875|-7.5|15.6|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 11-DTX-B2 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||15.6|-7.5|0.193
91653808|NCT02396381|183201054|SUPERIORITY||% Reduction|6.8||||0.018|TWO_SIDED|96.875|-0.216|13.3|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 8-epi-PGF2α will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||13.3|-0.216|0.018
91653809|NCT02396381|183201055|SUPERIORITY||% Reduction|43.5|||<|0.001|TWO_SIDED|96.875|33.7|51.9|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of Total NNAL will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||51.9|33.7|<0.001
91710217|NCT00803712|183312872|SUPERIORITY_OR_OTHER|||||||0.0002||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.0002
91710218|NCT00803712|183312873|SUPERIORITY_OR_OTHER|||||||0.0139||||||Adjusted p-value is presented. P-value is adjusted using Dubey and Armitage-Parmer method of adjusting for multiple comparisons|Cochran-Mantel-Haenszel|||||||0.0139
91609973|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|||||TWO_SIDED|80.0|-8.42|0.18||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.18|-8.42|
91609974|NCT01933672|183112823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||||TWO_SIDED|80.0|-2.6|5.89||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.89|-2.60|
91609975|NCT01933672|183112826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|80.0|0.21|1.39||||||Compared with baseline||1.39|0.21|
91609976|NCT01933672|183112826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|80.0|-0.43|0.93||||||Compared with baseline||0.93|-0.43|
91609977|NCT01933672|183112826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||||TWO_SIDED|80.0|-0.92|0.4||||||Compared with baseline||0.40|-0.92|
91609978|NCT01933672|183112826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||||TWO_SIDED|80.0|0.17|1.95||||||||1.95|0.17|
91609979|NCT01933672|183112826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|80.0|-0.45|1.47||||||||1.47|-0.45|
91609980|NCT00524303|183112835|SUPERIORITY_OR_OTHER||Percent difference|-9.0|||||TWO_SIDED|95.0|-38.1|17.9|||||Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.|||17.9|-38.1|
91788783|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.9|35.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.1|12.9|
91788784|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.7|30.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||30.8|14.7|
91523652|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Week 24.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.657
91609981|NCT00524303|183112835|SUPERIORITY_OR_OTHER||Percent difference|20.0|||||TWO_SIDED|95.0|-8.0|49.4|||||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||49.4|-8.0|
91523653|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value is for Week 36.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.595
91523654|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value for Week 48.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.142
91523655|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.551||95.0||||P-value for Week 60.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.551
91523656|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Week 72.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.779
91609982|NCT00524303|183112836|SUPERIORITY_OR_OTHER||Percent Difference|7.0||||0.627|TWO_SIDED|95.0|-17.8|32.5|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.|||32.5|-17.8|0.627
91609983|NCT00524303|183112836|SUPERIORITY_OR_OTHER||Percent Difference|0.0||||1|TWO_SIDED|95.0|-25.1|25.1|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||25.1|-25.1|1.000
91609984|NCT01145391|183112843|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.5||95.0||||For systolic blood pressure|Mixed Models Analysis|||||||0.50
91609985|NCT01877655|183112855|SUPERIORITY||Odds Ratio (OR)|1.27||||0.205|TWO_SIDED|95.0|0.87|1.85||P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness \& donor CMV serostatus.|Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.||1.85|0.87|0.205
91609986|NCT01877655|183112856|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.748|TWO_SIDED|95.0|0.76|1.22||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV viremia through 1 year posttransplant. CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The 95% CI was based on cumulative incidence function CMV viremia rate at 1 year.||1.22|0.76|0.748
91609987|NCT01877655|183112857|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.8|1.29||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV-specific antiviral therapy (AVT) through 1 year. Time to first adjudicated CMV-specific therapy was defined as time to the start of AVT for CMV viremia. CMV-specific AVT was determined by the adjudication committee. Rate was based on cumulative incidence function estimate at 1 year.||1.29|0.80|0.888
91609988|NCT01877655|183112858|SUPERIORITY||Odds Ratio (OR)|1.05||||0.802|TWO_SIDED|95.0|0.73|1.51||P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.|Analysis of composite of CMV viremia and adjudicated CMV-AVT. The CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.||1.51|0.73|0.802
91609989|NCT01877655|183112859|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.8|1.28||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of rate of adjudicated CMV AVT or CMV EOD. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD and were determined by the adjudication committee. Rate based on cumulative incidence function estimate at 1 year.||1.28|0.80|0.928
91609990|NCT01877655|183112860|SUPERIORITY||Odds Ratio (OR)|1.18||||0.393|TWO_SIDED|95.0|0.81|1.73||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Analysis of all-cause mortality at 1 year. Participants with unknown survival status at 1 year were considered dead for this analysis.||1.73|0.81|0.393
91609991|NCT00095121|183112861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||End of double-blind treatment|Fisher Exact|||After unblinding the results, due to the small number of responders in the placebo group, it was determined that a statistical exact test would be more appropriate in the evaluation of treatment group differences than the originally planned 95% confidence intervals of the difference between the groups. Therefore, the results were analyzed by study visit, and a Fisher exact test was used to evaluate treatment differences between the adefovir dipivoxil and placebo groups.||||<0.001
91609992|NCT00095121|183112877|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Loss|Fisher Exact|||||||0.051
91609993|NCT00095121|183112877|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Seroconversion|Fisher Exact|||||||0.051
91609997|NCT05176847|183112907|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.97||0.09|TWO_SIDED|95.0|-3.71|0.09|||Mixed Models Analysis|Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. Models: time, group, group x time.|||Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. Models: time, group, group x time.|0.09|-3.71|0.09
91610005|NCT05248945|183113047|OTHER||Ratio of test and reference treatment|15.83|||||TWO_SIDED|90.0|13.26|18.9||||||||18.90|13.26|
91610006|NCT05248945|183113048|OTHER||Ratio of test and reference treatment|17.03|||||TWO_SIDED|90.0|13.59|21.33||||||||21.33|13.59|
91610007|NCT05248945|183113071|OTHER||Ratio of test and reference treatment|14.98|||||TWO_SIDED|90.0|12.6|17.82||||||||17.82|12.60|
91610008|NCT05248945|183113074|OTHER||Ratio of test and reference treatment|49.66|||||TWO_SIDED|90.0|44.93|54.9||||||||54.90|44.93|
91610009|NCT05248945|183113075|OTHER||Ratio of test and reference treatment|49.41|||||TWO_SIDED|90.0|44.79|54.51||||||||54.51|44.79|
91610010|NCT05248945|183113076|OTHER||Ratio of test and reference treatment|69.65|||||TWO_SIDED|90.0|60.34|80.4||||||||80.40|60.34|
91610011|NCT05090423|183113090|OTHER|||||||0.018|||||||ANOVA|||||||0.018
91788785|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.2|35.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.5|12.2|
91610016|NCT05733286|183113129|SUPERIORITY|||||||0.853||||||Given an SD of approximately 35 min for TST in healthy adults, a sample size of 58 subjects per group will provide 86% power to detect a 20 min difference in TST between treatment groups using a two-sample t-test with a two-sided alpha of 0.05.|t-test, 2 sided|||||||0.853
91610017|NCT05733286|183113130|SUPERIORITY|||||||0.34||||||Unadjusted. P \< 0.05 is considered significant. A sample size of 58 patients per group will provide 80% power to detect a 0.95-point difference between treatment groups using a two-sided t-test with an alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.340
91788786|NCT02446743|183457891|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|10.6|32.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.9|10.6|
91710219|NCT00803712|183312874|SUPERIORITY_OR_OTHER|||||||0.2386||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.2386
91788787|NCT02446743|183457892|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.0|4.5||Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4.5|-15.0|
91788788|NCT02446743|183457892|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-17.0|11.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.4|-17.0|
91710220|NCT00803712|183312875|SUPERIORITY_OR_OTHER|||||||0.0875|||||||Cochran-Mantel-Haenszel|||||||0.0875
91523657|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Week 84.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.175
91710221|NCT00803712|183312876|SUPERIORITY_OR_OTHER|||||||0.4304|||||||Cochran-Mantel-Haenszel|||||||0.4304
91653810|NCT02396381|183201056|SUPERIORITY||% Reduction|32.2|||<|0.001|TWO_SIDED|96.875|24.5|39.0|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis will test if the mean level of COHb for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||39|24.5|<0.001
91610028|NCT05098015|183113159|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|4.16||0.95|TWO_SIDED||||||Regression, Linear|||||||0.95
91653811|NCT04033445|183201084|SUPERIORITY||Adjusted treatment difference|33.6|||<|0.001|TWO_SIDED|95.0|20.9|46.3|||Cochran-Mantel-Haenszel (CMH) chi-square||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||46.3|20.9|< 0.001
91653812|NCT04033445|183201084|SUPERIORITY||Adjusted treatment difference|33.1|||<|0.001|TWO_SIDED|95.0|20.8|45.4|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||45.4|20.8|< 0.001
91610029|NCT05098015|183113160|SUPERIORITY||Slope|4.38|STANDARD_ERROR_OF_MEAN|3.12||0.16|TWO_SIDED||||||Regression, Linear|||||||0.16
91610030|NCT05098015|183113161|SUPERIORITY||Slope|-0.46|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED||||||Regression, Linear|||||||<.001
91610031|NCT05098015|183113162|SUPERIORITY||Slope|0.67|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED||||||Regression, Linear|||||||<.001
91653813|NCT04033445|183201085|SUPERIORITY||Adjusted treatment difference|14.9|||<|0.001|TWO_SIDED|95.0|9.9|19.9|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||19.9|9.9|< 0.001
91653814|NCT04033445|183201086|SUPERIORITY||Adjusted treatment difference|25.2|||<|0.001|TWO_SIDED|95.0|16.4|33.9|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||33.9|16.4|< 0.001
91653815|NCT04033445|183201086|SUPERIORITY||Adjusted treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|20.9|38.1|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||38.1|20.9|< 0.001
91653816|NCT00585780|183201110|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing HDD% among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.23||||0.016|TWO_SIDED|95.0|0.1|0.55||This is for the apriori hypothesis of significant AWX Treatment X Time effect.|Mixed Models Analysis|Simple effects were conducted to assess source of the interaction.||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.55|0.1|0.016
91710222|NCT00803712|183312877|SUPERIORITY_OR_OTHER|||||||0.091|||||||Cochran-Mantel-Haenszel|||||||0.0910
91710223|NCT00803712|183312878|SUPERIORITY_OR_OTHER|||||||0.952|||||||Cochran-Mantel-Haenszel|||||||0.9520
91710224|NCT00803712|183312879|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
91710225|NCT00803712|183312880|SUPERIORITY_OR_OTHER|||||||0.0611|||||||Cochran-Mantel-Haenszel|||||||0.0611
91710226|NCT00803712|183312881|SUPERIORITY_OR_OTHER|||||||0.3298|||||||Cochran-Mantel-Haenszel|||||||0.3298
91523658|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Week 96.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.018
91788789|NCT02446743|183457892|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-8.0|||||TWO_SIDED|95.0|-20.0|7.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||7.3|-20.0|
91653817|NCT00585780|183201111|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing percent of drinking days (DD%) among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.5||||0.002|TWO_SIDED|95.0|0.28|0.92||This is for apriori hypothesized significant AW X Treatment X Post-full dose time interaction effect.|Mixed Models Analysis|||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.92|0.28|0.002
91710227|NCT00803712|183312882|SUPERIORITY_OR_OTHER|||||||0.4436|||||||Cochran-Mantel-Haenszel|||||||0.4436
91788790|NCT02446743|183457892|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||6.2|-0.9|
91788791|NCT02446743|183457892|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
91788792|NCT02446743|183457892|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
91788793|NCT02446743|183457892|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1(V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
91653818|NCT02978326|183201146|SUPERIORITY||Least Squares (LS) Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.37||0.0028|TWO_SIDED|95.0|-6.9|-1.5||Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||||-1.5|-6.9|0.0028
91653819|NCT02978326|183201147|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.19||0.0252|TWO_SIDED|95.0|-5.1|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 3||-0.3|-5.1|0.0252
91523659|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for Week 108.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.047
91653820|NCT02978326|183201147|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.31||0.0106|TWO_SIDED|95.0|-6.0|-0.8||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 8||-0.8|-6.0|0.0106
91653821|NCT02978326|183201147|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.44||0.0321|TWO_SIDED|95.0|-6.0|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 21||-0.3|-6.0|0.0321
91653822|NCT02978326|183201147|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.34||0.0027|TWO_SIDED|95.0|-6.7|-1.4||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 45||-1.4|-6.7|0.0027
91653823|NCT02978326|183201148|SUPERIORITY||Odds Ratio (OR)|1.79||||0.1004|TWO_SIDED|95.0|0.89|3.6||Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 3||3.60|0.89|0.1004
91523660|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for Week 120.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.027
91523661|NCT00279201|182923064|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value is for Endpoint.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.017
91653824|NCT02978326|183201148|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0127|TWO_SIDED|95.0|1.2|4.45||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 8||4.45|1.20|0.0127
91653825|NCT02978326|183201148|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0049|TWO_SIDED|95.0|1.34|5.16||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 15||5.16|1.34|0.0049
91653826|NCT02978326|183201148|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0763|TWO_SIDED|95.0|0.94|3.64||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 21||3.64|0.94|0.0763
91653827|NCT02978326|183201148|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0216|TWO_SIDED|95.0|1.13|4.6||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 45||4.60|1.13|0.0216
91523662|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.218
91523663|NCT00279201|182923065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
91523664|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value is for Baseline AM 2-hour (hr) postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.897
91610048|NCT04063215|183113202|OTHER|||||||0.048|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.048
91653828|NCT02978326|183201149|SUPERIORITY||Odds Ratio (OR)|3.89||||0.02|TWO_SIDED|95.0|1.24|12.23||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 3||12.23|1.24|0.0200
91610049|NCT04063215|183113203|OTHER|||||||0.2|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.2
91610050|NCT04063215|183113204|OTHER|||||||0.6|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.6
91653829|NCT02978326|183201149|SUPERIORITY||Odds Ratio (OR)|1.91||||0.099|TWO_SIDED|95.0|0.89|4.13||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 8||4.13|0.89|0.0990
91653830|NCT02978326|183201149|SUPERIORITY||Odds Ratio (OR)|2.53||||0.011|TWO_SIDED|95.0|1.24|5.17||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 15||5.17|1.24|0.0110
91653831|NCT02978326|183201149|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1982|TWO_SIDED|95.0|0.79|3.19||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 21||3.19|0.79|0.1982
91653832|NCT02978326|183201149|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0091|TWO_SIDED|95.0|1.26|5.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 45||5.03|1.26|0.0091
91653833|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.41||0.3832|TWO_SIDED|95.0|-6.9|2.7||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 3||2.7|-6.9|0.3832
91653834|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|2.6||0.0415|TWO_SIDED|95.0|-10.5|-0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 8||-0.2|-10.5|0.0415
91653835|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.71||0.0606|TWO_SIDED|95.0|-10.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 15||0.2|-10.5|0.0606
91710228|NCT00803712|183312883|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||<0.0001
91653836|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0318|TWO_SIDED|95.0|-12.1|-0.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 21||-0.6|-12.1|0.0318
91610051|NCT04063215|183113205|OTHER|||||||0.1|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.10
91610052|NCT04063215|183113206|OTHER|||||||0.4|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.4
91610053|NCT04063215|183113207|OTHER|||||||0.6|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.6
91610054|NCT04063215|183113208|OTHER|||||||0.5|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.5
91610055|NCT04063215|183113209|OTHER||||||>|0.9|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||>0.9
91610056|NCT04063215|183113210|OTHER|||||||0.8|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.8
91610057|NCT04063215|183113211|OTHER|||||||0.002|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.002
91610058|NCT04063215|183113212|OTHER|||||||0.8|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.8
91610059|NCT04063215|183113213|OTHER|||||||0.069|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.069
91610060|NCT04063215|183113214|OTHER|||||||0.6|||||||Mixed Models Analysis|||For inflammatory cytokines, time course data will be analyzed using a GLMM to test differences across time between pre- and post- treatment. The dependent variables will be the neuroinflammatory biomarkers with time (to model the trajectory) and GOSE (3-4 or 5-8) as covariates and a random subject effect (to account for within subject correlation). Point estimates of pre- and posttreatment differences will be reported along with 95% confidence interval.||||0.6
91610061|NCT04063215|183113215|OTHER||Odds Ratio (OR)|1.33||||0.63|TWO_SIDED|95.0|0.43|4.19||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Logistic|||A proportional odds logistic regression model was used to analyze the data over time. This model is used to predict an ordered categorical outcome over time by assuming the odds ratio between any two outcome categories is constant throughout all time points. Null hypothesis is that time has no effect on the cumulative odds for a patient to be in a higher category after being evaluated on the GOS-E. Odds ratio \>1 indicates higher likelihood of being in higher categories compared to at baseline.|This statistical analysis applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|4.19|0.43|0.63
91523665|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value is for Endpoint AM 2-hour postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.138
91610062|NCT04063215|183113215|OTHER||Odds Ratio (OR)|1.71||||0.36|TWO_SIDED|95.0|0.55|5.45||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Logistic|||A proportional odds logistic regression model was used to analyze the data over time. This model is used to predict an ordered categorical outcome over time by assuming the odds ratio between any two outcome categories is constant throughout all time points. Null hypothesis is that time has no effect on the cumulative odds for a patient to be in a higher category after being evaluated on the GOS-E. Odds ratio \>1 indicates higher likelihood of being in higher categories compared to at baseline.|This statistical analysis applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|5.45|0.55|0.36
91610063|NCT04063215|183113216|OTHER||Mean Difference (Net)|-0.38||||0.047|TWO_SIDED|95.0|-0.75|-0.01||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.19|Effect size: 0.19|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-0.01|-0.75|0.047
91610064|NCT04063215|183113216|OTHER||Mean Difference (Net)|-0.749||||0.00023|TWO_SIDED|95.0|-1.12|-0.379||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.19|Effect size: 0.19|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-0.379|-1.12|0.00023
91610065|NCT04063215|183113217|OTHER||Mean Difference (Net)|4.86||||0.00027|TWO_SIDED|95.0|2.42|7.29||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.63|Effect size: 0.63|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||7.29|2.42|0.00027
91610066|NCT04063215|183113217|OTHER||Mean Difference (Net)|4.9||||0.00019|TWO_SIDED|95.0|2.506|7.294||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.63|Effect size: 0.63|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||7.294|2.506|0.00019
91610067|NCT04063215|183113218|OTHER||Mean Difference (Net)|-2.43||||0.19|TWO_SIDED|95.0|-6.07|-1.18||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.38|Effect size: 0.38|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-1.18|-6.07|0.19
91610068|NCT04063215|183113218|OTHER||Mean Difference (Net)|-3.7||||0.043|TWO_SIDED|95.0|-7.26|-0.14||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.38|Effect size: 0.38|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-0.14|-7.26|0.043
91610069|NCT04063215|183113219|OTHER||Mean Difference (Net)|-3.63||||0.069|TWO_SIDED|95.0|-7.55|0.26||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.48|Effect size: 0.48|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||0.26|-7.55|0.069
91613389|NCT00719576|183121180|SUPERIORITY|||||||0.016||||||KOOS Response Rate: a participant is regarded as a responder for KOOS if a 10-point improvement in both KOOS Pain and Function (SRA) scores was achieved with respect to Baseline. Otherwise, the patient is regarded as a nonresponder.|Cochran-Mantel-Haenszel|p-value was calculated for response categories 'Responded' and 'Not responded' using a Cochran-Mantel-Haenszel χ2 Test stratified by Center||Differences between groups were tested by the Cochran-Mantel-Haenszel chi-squared test stratified by center for responders.||||0.016
91523666|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||P-value is for Baseline midday premeal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.867
91610070|NCT04063215|183113219|OTHER||Mean Difference (Net)|-6.15||||0.026|TWO_SIDED|95.0|-9.983|-2.317||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.48|Effect size: 0.48|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-2.317|-9.983|0.026
91610071|NCT04063215|183113220|OTHER||Mean Difference (Net)|-4.43||||0.02|TWO_SIDED|95.0|-8.12|-0.79||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.53|Effect size: 0.53|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-0.79|-8.12|0.020
91610072|NCT04063215|183113220|OTHER||Mean Difference (Net)|-5.7||||0.0029|TWO_SIDED|95.0|-9.297|-2.103||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.53|Effect size: 0.53|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-2.103|-9.297|0.0029
91610073|NCT04063215|183113221|OTHER||Mean Difference (Net)|-3.64||||0.054|TWO_SIDED|95.0|-7.33|0.02||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.53|Effect size: 0.53|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||0.02|-7.33|0.054
91610074|NCT04063215|183113221|OTHER||Mean Difference (Net)|-5.85||||0.0023|TWO_SIDED|95.0|-9.456|-2.244||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.53|Effect size: 0.53|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||-2.244|-9.456|0.0023
91788794|NCT02446743|183457892|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
91610075|NCT04063215|183113222|OTHER||Mean Difference (Net)|3.0||||0.0097|TWO_SIDED|95.0|0.79|5.22||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.51|Effect size: 0.51|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||5.22|0.79|0.0097
91610076|NCT04063215|183113222|OTHER||Mean Difference (Net)|4.51||||0.00017|TWO_SIDED|95.0|2.335|6.685||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.51|Effect size: 0.51|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||6.685|2.335|0.00017
91610077|NCT04063215|183113223|OTHER||Mean Difference (Net)|2.58||||0.049|TWO_SIDED|95.0|0.04|5.14||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.40|Effect size: 0.40|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||5.14|0.04|0.049
91710229|NCT00803712|183312884|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
91788795|NCT02446743|183457892|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
91610078|NCT04063215|183113223|OTHER||Mean Difference (Net)|3.555||||0.0069|TWO_SIDED|95.0|1.054|6.056||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.40|Effect size: 0.40|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||6.056|1.054|0.0069
91610079|NCT04063215|183113224|OTHER||Mean Difference (Net)|4.03||||0.0064|TWO_SIDED|95.0|1.21|6.82||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.57|Effect size: 0.57|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||6.82|1.21|0.0064
91610080|NCT04063215|183113224|OTHER||Mean Difference (Net)|5.005||||0.00076|TWO_SIDED|95.0|2.251|7.759||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.57|Effect size: 0.57|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||7.759|2.251|0.00076
91610081|NCT04063215|183113225|OTHER||Mean Difference (Net)|3.13||||0.0084|TWO_SIDED|95.0|0.86|5.38||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.23|Effect size: 0.23|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||5.38|0.86|0.0084
91610082|NCT04063215|183113225|OTHER||Mean Difference (Net)|2.72||||0.018|TWO_SIDED|95.0|0.5|4.94||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.23|Effect size: 0.23|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||4.94|0.5|0.018
91613390|NCT00719576|183121182|SUPERIORITY||||||<|0.001||||||KOOS activities of daily living p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
91613391|NCT00719576|183121182|SUPERIORITY|||||||0.029||||||KOOS knee-related quality of life p-value 0.029|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||0.029
91613392|NCT00719576|183121182|SUPERIORITY||||||<|0.001||||||KOOS other symptoms p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
91613393|NCT04964063|183121212|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.47|-1.19|||ANOVA||Q1: How intense are the sensation|||-1.19|-1.47|<.0001
91613394|NCT04964063|183121212|OTHER||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.77|-1.45|||ANOVA||Q2: How bothered are you by any sensation|||-1.45|-1.77|<.0001
91710230|NCT00803712|183312885|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||0.0040
91610083|NCT04063215|183113226|OTHER||Mean Difference (Net)|2.22||||0.024|TWO_SIDED|95.0|0.33|4.13||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.36|Effect size: 0.36|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||4.13|0.33|0.024
91610084|NCT04063215|183113226|OTHER||Mean Difference (Net)|2.31||||0.017|TWO_SIDED|95.0|0.445|4.175||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.36|Effect size: 0.36|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||4.175|0.445|0.017
91610085|NCT04063215|183113227|OTHER||Mean Difference (Net)|1.48||||0.11|TWO_SIDED|95.0|-0.35|3.31||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.24|Effect size: 0.24|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||3.31|-0.35|0.11
91610086|NCT04063215|183113227|OTHER||Mean Difference (Net)|2.69||||0.0046|TWO_SIDED|95.0|0.893|4.487||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|Effect size: 0.24|Effect size: 0.24|Neuropsychological and Functional outcome measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 and/or 12 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for all outcomes at 6 and 12 months after treatment.||4.487|0.893|0.0046
91610087|NCT04063215|183113228|OTHER||Mean Difference (Net)|5.69||||0.0081|TWO_SIDED|95.0|1.58|9.77||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.60|Effect size: 0.60|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||9.77|1.58|0.0081
91710231|NCT00803712|183312886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
91710232|NCT00803712|183312887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium||||||<0.0001
91710233|NCT00803712|183312888|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
91610088|NCT04063215|183113228|OTHER||Mean Difference (Net)|8.505||||0.00017|TWO_SIDED|95.0|4.42|12.606||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.60|Effect size: 0.60|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||12.606|4.42|0.00017
91610089|NCT04063215|183113229|OTHER||Mean Difference (Net)|0.846||||0.64|TWO_SIDED|95.0|-2.767|4.515||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.10|Effect size: 0.10|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||4.515|-2.767|0.64
91523667|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Endpoint midday premeal blood.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.031
91613395|NCT04964063|183121212|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.33|-1.0|||ANOVA||Q3: How well can you tolerate sensations|||-1.00|-1.33|<.0001
91613396|NCT04964063|183121213|OTHER||Median Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.98|-1.7|||ANOVA||Q1: How intense are the sensation|||-1.70|-1.98|<.0001
91613397|NCT04964063|183121213|OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.33|-2.02|||ANOVA||Q2: How bothered are you by any sensation|||-2.02|-2.33|<.0001
91523668|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value is for Baseline midday 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.792
91613398|NCT04964063|183121213|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.61|-1.29|||ANOVA||Q3: How well can you tolerate sensations|||-1.29|-1.61|<.0001
91613399|NCT04964063|183121214|OTHER||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.43|-2.15|||ANOVA||Q1: How intense are the sensation|||-2.15|-2.43|<.0001
91613400|NCT04964063|183121214|OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.79|-2.47|||ANOVA||Q2: How bothered are you by any sensation|||-2.47|-2.79|<.0001
91613401|NCT04964063|183121214|OTHER||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.02|-1.7|||ANOVA||Q3: How well can you tolerate sensations|||-1.70|-2.02|<.0001
91613402|NCT04964063|183121215|OTHER||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.68|-2.4|||ANOVA||Q1: How intense are the sensation|||-2.40|-2.68|<.0001
91613403|NCT04964063|183121215|OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.05|-2.73|||ANOVA||Q2: How bothered are you by any sensation|||-2.73|-3.05|<.0001
91653837|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.69||0.0047|TWO_SIDED|95.0|-13.0|-2.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 45||-2.4|-13.0|0.0047
91653838|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|2.5||0.0053|TWO_SIDED|95.0|-12.0|-2.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3||-2.1|-12.0|0.0053
91523669|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||P-value is for Endpoint midday 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.510
91523670|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.535||95.0||||P-value is for Baseline PM pre-meal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.535
91653839|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.76||0.0181|TWO_SIDED|95.0|-12.1|-1.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8||-1.1|-12.1|0.0181
91710234|NCT00803712|183312889|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
91610090|NCT04063215|183113230|OTHER||Mean Difference (Net)|2.59||||0.21|TWO_SIDED|95.0|-1.52|6.65||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.48|Effect size: 0.48|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||6.65|-1.52|0.21
91610091|NCT04063215|183113230|OTHER||Mean Difference (Net)|4.318||||0.04|TWO_SIDED|95.0|0.241|8.399||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.48|Effect size: 0.48|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||8.399|0.241|0.040
91610092|NCT04063215|183113231|OTHER||Mean Difference (Net)|-0.86||||0.3|TWO_SIDED|95.0|-2.52|0.78||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.07|Effect size: 0.07|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||0.78|-2.52|0.30
91610093|NCT04063215|183113231|OTHER||Mean Difference (Net)|0.789||||0.33|TWO_SIDED|95.0|-0.83|2.409||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.07|Effect size: 0.07|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||2.409|-0.83|0.33
91653840|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|2.82||0.0007|TWO_SIDED|95.0|-15.3|-4.2|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15||-4.2|-15.3|0.0007
91710235|NCT00803712|183312890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
91710236|NCT00803712|183312891|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0085
91710237|NCT00803712|183312892|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0710
91710238|NCT00803712|183312893|SUPERIORITY_OR_OTHER|||||||0.3546|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.3546
91610094|NCT04063215|183113232|OTHER||Mean Difference (Net)|0.1||||0.96|TWO_SIDED|95.0|-3.49|3.66||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.31|Effect size: 0.31|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||3.66|-3.49|0.96
91610095|NCT04063215|183113232|OTHER||Mean Difference (Net)|2.985||||0.1|TWO_SIDED|95.0|-0.588|6.562||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.31|Effect size: 0.31|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||6.562|-0.588|0.10
91788796|NCT02446743|183457892|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-20.0|||||TWO_SIDED|95.0|-35.2|-7.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-7.5|-35.2|
91613404|NCT04964063|183121215|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.2|-1.87|||ANOVA||Q3: How well can you tolerate sensations|||-1.87|-2.20|<.0001
91788797|NCT02446743|183457892|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-32.0|||||TWO_SIDED|95.0|-46.5|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.7|-46.5|
91788798|NCT02446743|183457892|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-28.0|||||TWO_SIDED|95.0|-38.4|-17.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-17.1|-38.4|
91788799|NCT02446743|183457892|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|9.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.2|-19.2|
91788800|NCT02446743|183457892|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-14.1|12.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||12.3|-14.1|
91788801|NCT02446743|183457892|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-13.6|5.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||5.6|-13.6|
91788802|NCT02446743|183457892|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|12.0|||||TWO_SIDED|95.0|3.6|21.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.6|3.6|
91788803|NCT02446743|183457892|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|6.4|24.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.6|6.4|
91788804|NCT02446743|183457892|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|14.0|||||TWO_SIDED|95.0|7.6|20.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||20.3|7.6|
91788805|NCT02446743|183457893|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-44.0|||||TWO_SIDED|95.0|-52.7|-33.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-33.1|-52.7|
91788806|NCT02446743|183457893|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.6|-3.9|
91788807|NCT02446743|183457893|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.7|2.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.4|-2.7|
91610096|NCT04063215|183113233|OTHER||Mean Difference (Net)|3.34||||0.043|TWO_SIDED|95.0|0.13|6.53||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.21|Effect size: 0.21|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||6.53|0.13|0.043
91610097|NCT04063215|183113233|OTHER||Mean Difference (Net)|2.718||||0.1|TWO_SIDED|95.0|-0.484|5.917||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.21|Effect size: 0.21|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||5.917|-0.484|0.10
91610098|NCT04063215|183113234|OTHER||Mean Difference (Net)|2.39||||0.24|TWO_SIDED|95.0|-1.73|6.44||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.20|Effect size: 0.20|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||6.44|-1.73|0.24
91610099|NCT04063215|183113234|OTHER||Mean Difference (Net)|3.79||||0.061|TWO_SIDED|95.0|-0.152|7.72||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.20|Effect size: 0.20|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||7.72|-0.152|0.061
91610100|NCT04063215|183113235|OTHER||Mean Difference (Net)|1.22||||0.49|TWO_SIDED|95.0|-2.28|4.71||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.43|Effect size: 0.43|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||4.71|-2.28|0.49
91610101|NCT04063215|183113235|OTHER||Mean Difference (Net)|7.001||||0.00026|TWO_SIDED|95.0|3.506|10.494||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.43|Effect size: 0.43|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||10.494|3.506|0.00026
91610102|NCT04063215|183113236|OTHER||Mean Difference (Net)|3.98||||0.083|TWO_SIDED|95.0|-0.51|8.46||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.61|Effect size: 0.61|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||8.46|-0.51|0.083
91653841|NCT02978326|183201150|OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.79||0.0332|TWO_SIDED|95.0|-11.5|-0.5|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21||-0.5|-11.5|0.0332
91610103|NCT04063215|183113236|OTHER||Mean Difference (Net)|9.033||||0.00025|TWO_SIDED|95.0|4.55|13.52||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.61|Effect size: 0.61|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||13.52|4.55|0.00025
91610104|NCT04063215|183113237|OTHER||Mean Difference (Net)|0.25||||0.53|TWO_SIDED|95.0|-0.55|1.05||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.20|Effect size: 0.20|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||1.05|-0.55|0.53
91610105|NCT04063215|183113237|OTHER||Mean Difference (Net)|1.043||||0.1|TWO_SIDED|95.0|0.284|1.805||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.20|Effect size: 0.20|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||1.805|0.284|0.10
91610106|NCT04063215|183113238|OTHER||Mean Difference (Net)|0.83||||0.034|TWO_SIDED|95.0|0.07|1.59||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.28|Effect size: 0.28|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||1.59|0.07|0.034
91653842|NCT02978326|183201150|OTHER||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.8||0.0048|TWO_SIDED|95.0|-13.5|-2.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45||-2.5|-13.5|0.0048
91788808|NCT02446743|183457893|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-46.0|||||TWO_SIDED|95.0|-58.4|-29.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-29.8|-58.4|
91610107|NCT04063215|183113238|OTHER||Mean Difference (Net)|1.043||||0.009|TWO_SIDED|95.0|0.284|1.805||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.28|Effect size: 0.28|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||1.805|0.284|0.0090
91610108|NCT04063215|183113239|OTHER||Mean Difference (Net)|2.8||||0.13|TWO_SIDED|95.0|-0.84|6.41||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.25|Effect size: 0.25|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||6.41|-0.84|0.13
91610109|NCT04063215|183113239|OTHER||Mean Difference (Net)|4.486||||0.016|TWO_SIDED|95.0|0.938|8.026||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.25|Effect size: 0.25|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||8.026|0.938|0.016
91610110|NCT04063215|183113240|OTHER||Mean Difference (Net)|-0.11||||0.84|TWO_SIDED|95.0|-1.23|0.97||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.33|Effect size: 0.33|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||0.97|-1.23|0.84
91610111|NCT04063215|183113240|OTHER||Mean Difference (Net)|1.083||||0.053|TWO_SIDED|95.0|-0.028|2.162||This p-value applies to data regarding 1 year Post-Infusion (Visit 7 - Week 56) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Regression, Linear|Effect size: 0.33|Effect size: 0.33|Neurocognitive outcome measures will be analyzed using linear regression models to estimate differences across time points (pre- and post-treatment). Mean differences with 95% confidence intervals (CI) were determined for all outcomes at 6 and 12 months after treatment.||2.162|-0.028|0.053
91610112|NCT04063215|183113241|OTHER||Mean Difference (Net)|-1050.25||||0.27|TWO_SIDED|95.0|-2958.69|858.19||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||858.19|-2958.69|0.27
91613405|NCT04964063|183121216|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.84|-2.55|||ANOVA||Q1: How intense are the sensation|||-2.55|-2.84|<.0001
91613406|NCT04964063|183121216|OTHER||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.15|-2.83|||ANOVA||Q2: How bothered are you by any sensation|||-2.83|-3.15|<.0001
91610113|NCT04063215|183113242|OTHER||Mean Difference (Net)|-365.57||||0.61|TWO_SIDED|95.0|-1835.1|1103.97||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||1103.97|-1835.10|0.61
91610114|NCT04063215|183113243|OTHER||Mean Difference (Net)|-13.17||||0.19|TWO_SIDED|95.0|-33.32|6.98||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||6.98|-33.32|0.19
91653843|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.12||0.184|TWO_SIDED|95.0|-10.3|2.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3||2.0|-10.3|0.1840
91653844|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|3.31||0.0462|TWO_SIDED|95.0|-13.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8||-0.1|-13.2|0.0462
91653845|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|3.36||0.015|TWO_SIDED|95.0|-14.9|-1.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15||-1.6|-14.9|0.0150
91523671|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||P-value is for Endpoint PM pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.517
91610115|NCT04063215|183113244|OTHER||Mean Difference (Net)|-32.35||||0.0072|TWO_SIDED|95.0|-54.61|-10.09||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||-10.09|-54.61|0.0072
91613407|NCT04964063|183121216|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.35|-2.02|||ANOVA||Q3: How well can you tolerate sensations|||-2.02|-2.35|<.0001
91613408|NCT04964063|183121217|OTHER||Median Difference (Final Values)|-2.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-3.08|-2.79|||ANOVA||Q1: How intense are the sensation|||-2.79|-3.08|<.0001
91613409|NCT04964063|183121217|OTHER||Median Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.4|-3.08|||ANOVA||Q2: How bothered are you by any sensation|||-3.08|-3.40|<.0001
91610116|NCT04063215|183113245|OTHER||Mean Difference (Net)|-21.88||||0.03|TWO_SIDED|95.0|-41.11|-2.65||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||-2.65|-41.11|0.03
91613410|NCT04964063|183121217|OTHER||Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.53|-2.21|||ANOVA||Q3: How well can you tolerate sensations|||-2.21|-2.53|<.0001
91613411|NCT04964063|183121219|OTHER||Mean Difference (Final Values)|-17.93|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-20.81|-15.05|||ANOVA|||||-15.05|-20.81|<.0001
91613412|NCT04964063|183121220|OTHER||Mean Difference (Final Values)|-31.2|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-34.04|-28.36|||ANOVA|||||-28.36|-34.04|<.0001
91613413|NCT04964063|183121221|OTHER||Mean Difference (Final Values)|-39.45|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-42.3|-36.59|||ANOVA|||||-36.59|-42.30|<.0001
91613414|NCT04964063|183121222|OTHER||Mean Difference (Final Values)|-44.37|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-47.24|-41.49|||ANOVA|||||-41.49|-47.24|<.0001
91613415|NCT04964063|183121223|OTHER||Mean Difference (Final Values)|-48.04|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-50.96|-45.12|||ANOVA|||||-45.12|-50.96|<.0001
91613416|NCT04964063|183121224|OTHER||Mean Difference (Final Values)|-52.47|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-55.33|-49.62|||ANOVA|||||-49.62|-55.33|<.0001
91613417|NCT04964063|183121226|OTHER||Mean Difference (Final Values)|-2.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.88|-2.02|||ANOVA|||||-2.02|-2.88|<.0001
91610117|NCT04063215|183113246|OTHER||Mean Difference (Net)|-42.03||||0.061|TWO_SIDED|95.0|-85.66|1.61||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||1.61|-85.66|0.061
91610118|NCT04063215|183113247|OTHER||Mean Difference (Net)|-39.56||||0.18|TWO_SIDED|95.0|-98.67|19.56||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||19.56|-98.67|0.18
91613418|NCT04964063|183121227|OTHER||Mean Difference (Final Values)|-4.27|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-4.69|-3.85|||ANOVA|||||-3.85|-4.69|<.0001
91613419|NCT04964063|183121228|OTHER||Mean Difference (Final Values)|-5.71|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-6.13|-5.28|||ANOVA|||||-5.28|-6.13|<.0001
91613420|NCT04964063|183121229|OTHER||Mean Difference (Final Values)|-6.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.88|-6.02|||ANOVA|||||-6.02|-6.88|<.0001
91613421|NCT04964063|183121230|OTHER||Median Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-7.45|-6.58|||ANOVA|||||-6.58|-7.45|<.0001
91613422|NCT04964063|183121231|OTHER||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-7.87|-7.01|||ANOVA|||||-7.01|-7.87|<.0001
91653846|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.53||0.0245|TWO_SIDED|95.0|-15.0|-1.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21||-1.0|-15.0|0.0245
91710239|NCT00803712|183312894|SUPERIORITY_OR_OTHER|||||||0.7518|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.7518
91523672|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for Baseline PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.869
91523673|NCT00279201|182923065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
91610119|NCT04063215|183113248|OTHER||Mean Difference (Net)|8.25||||0.63|TWO_SIDED|95.0|-26.01|42.51||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||42.51|-26.01|0.63
91613423|NCT04964063|183121233|OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-7.46|-5.2|||ANOVA|||||-5.20|-7.46|<.0001
91613424|NCT04964063|183121234|OTHER||Mean Difference (Final Values)|-11.53|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-12.64|-10.41|||ANOVA|||||-10.41|-12.64|<.0001
91523674|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for Baseline 3AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.164
91613425|NCT04964063|183121235|OTHER||Mean Difference (Final Values)|-14.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-15.66|-13.42|||ANOVA|||||-13.42|-15.66|<.0001
91610120|NCT04063215|183113249|OTHER||Mean Difference (Net)|1.47||||0.85|TWO_SIDED|95.0|-14.84|17.79||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||17.79|-14.84|0.85
91610121|NCT04063215|183113250|OTHER||Mean Difference (Net)|-35.42||||0.24|TWO_SIDED|95.0|-95.21|24.36||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||24.36|-95.21|0.24
91610122|NCT04063215|183113251|OTHER||Mean Difference (Net)|-6.58||||0.31|TWO_SIDED|95.0|-19.5|6.34||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||6.34|-19.50|0.31
91610123|NCT04063215|183113252|OTHER||Mean Difference (Net)|-25.77||||0.018|TWO_SIDED|95.0|-46.25|-5.29||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||-5.29|-46.25|0.018
91610124|NCT04063215|183113253|OTHER||Mean Difference (Net)|-9.6||||0.067|TWO_SIDED|95.0|-19.79|0.59||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||0.59|-19.79|0.067
91610125|NCT04063215|183113254|OTHER||Mean Difference (Net)|-12.28||||0.069|TWO_SIDED|95.0|-25.45|0.88||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||0.88|-25.45|0.069
91653847|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|3.34||0.0054|TWO_SIDED|95.0|-16.0|-2.8||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45||-2.8|-16.0|0.0054
91653848|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|2.77||0.0972|TWO_SIDED|95.0|-10.1|0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 3||0.9|-10.1|0.0972
91653849|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.95||0.0155|TWO_SIDED|95.0|-13.1|-1.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 8||-1.4|-13.1|0.0155
91788809|NCT02446743|183457893|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-7.7|5.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.1|-7.7|
91610126|NCT04063215|183113255|OTHER||Mean Difference (Net)|-26.47||||0.027|TWO_SIDED|95.0|-49.12|-3.61||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||-3.61|-49.12|0.027
91610127|NCT04063215|183113256|OTHER||Mean Difference (Net)|-15.66||||0.24|TWO_SIDED|95.0|-42.09|10.77||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||10.77|-42.09|0.24
91610128|NCT04063215|183113257|OTHER||Mean Difference (Net)|-17.91||||0.079|TWO_SIDED|95.0|-37.83|2.01||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||2.01|-37.83|0.079
91610129|NCT04063215|183113258|OTHER||Mean Difference (Net)|-21.65||||0.29|TWO_SIDED|95.0|-62.91|19.61||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||19.61|-62.91|0.29
91610130|NCT04063215|183113259|OTHER||Mean Difference (Net)|-4.08||||0.24|TWO_SIDED|95.0|-11.01|2.84||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||2.84|-11.01|0.24
91613426|NCT04964063|183121236|OTHER||Median Difference (Final Values)|-16.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-17.67|-15.41|||ANOVA|||||-15.41|-17.67|<.0001
91613427|NCT04964063|183121237|OTHER||Mean Difference (Final Values)|-17.73|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-18.87|-16.58|||ANOVA|||||-16.58|-18.87|<.0001
91788810|NCT02446743|183457893|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
91613428|NCT04964063|183121238|OTHER||Mean Difference (Final Values)|-18.84|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-19.96|-17.72|||ANOVA|||||-17.72|-19.96|<.0001
91613429|NCT04964063|183121240|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.52|-1.56|||ANOVA|||||-1.56|-2.52|<.0001
91613430|NCT04964063|183121241|OTHER||Mean Difference (Final Values)|-3.69|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-4.17|-3.22|||ANOVA|||||-3.22|-4.17|<.0001
91613431|NCT04964063|183121242|OTHER||Mean Difference (Final Values)|-4.67|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.15|-4.2|||ANOVA|||||-4.20|-5.15|<.0001
91613432|NCT04964063|183121243|OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.72|-4.76|||ANOVA|||||-4.76|-5.72|<.0001
91610131|NCT04063215|183113260|OTHER||Mean Difference (Net)|12.33||||0.44|TWO_SIDED|95.0|-19.69|44.36||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||44.36|-19.69|0.44
91613433|NCT04964063|183121244|OTHER||Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-6.12|-5.14|||ANOVA|||||-5.14|-6.12|<.0001
91710240|NCT00947310|183312956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.85|0.24|0.01
91710241|NCT00947310|183312956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.06|TWO_SIDED|95.0|0.3|1.02|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||1.02|0.30|0.06
91710242|NCT00947310|183312957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.39|TWO_SIDED|95.0|0.71|2.47|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||2.47|0.71|0.39
91613434|NCT04964063|183121245|OTHER||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-6.72|-5.77|||ANOVA|||||-5.77|-6.72|<.0001
91613435|NCT04964063|183121247|OTHER||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-6.06|-4.44|||ANOVA|||||-4.44|-6.06|<.0001
91523675|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||P-value is for Endpoint 3AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.234
91613436|NCT04964063|183121248|OTHER||Mean Difference (Final Values)|-8.52|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-9.32|-7.72|||ANOVA|||||-7.72|-9.32|<.0001
91613437|NCT04964063|183121249|OTHER||Mean Difference (Final Values)|-10.55|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-11.35|-9.75|||ANOVA|||||-9.75|-11.35|<.0001
91613438|NCT04964063|183121250|OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-12.41|-10.79|||ANOVA|||||-10.79|-12.41|<.0001
91613439|NCT04964063|183121251|OTHER||Mean Difference (Final Values)|-12.63|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-13.45|-11.81|||ANOVA|||||-11.81|-13.45|<.0001
91613440|NCT04964063|183121252|OTHER||Mean Difference (Final Values)|-13.88|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-14.69|-13.08|||ANOVA|||||-13.08|-14.69|<.0001
91613441|NCT04964063|183121254|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.33|||ANOVA|||||-1.33|-2.43|<.0001
91613442|NCT04964063|183121255|OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.74|-2.65|||ANOVA|||||-2.65|-3.74|<.0001
91613443|NCT04964063|183121256|OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-4.53|-3.44|||ANOVA|||||-3.44|-4.53|<.0001
91613444|NCT04964063|183121257|OTHER||Mean Difference (Final Values)|-4.55|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-5.1|-4.0|||ANOVA|||||-4.00|-5.10|<.0001
91613445|NCT04964063|183121258|OTHER||Median Difference (Final Values)|-5.04|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-5.6|-4.48|||ANOVA|||||-4.48|-5.60|<.0001
91613446|NCT04964063|183121259|OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-6.62|-5.53|||ANOVA|||||-5.53|-6.62|<.0001
91613447|NCT04964063|183121261|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1091|TWO_SIDED|95.0|-0.12|0.01|||ANOVA|||||0.01|-0.12|0.1091
91613448|NCT04964063|183121262|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.19|-0.06|||ANOVA|||||-0.06|-0.19|<.0001
91613449|NCT04964063|183121263|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.23|-0.1|||ANOVA|||||-0.10|-0.23|<.0001
91613450|NCT04964063|183121264|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.11|||ANOVA|||||-0.11|-0.24|<.0001
91610132|NCT04063215|183113261|OTHER||Mean Difference (Net)|-3.25||||0.23|TWO_SIDED|95.0|-8.67|2.17||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||2.17|-8.67|0.23
91610133|NCT04063215|183113262|OTHER||Mean Difference (Net)|4.73||||0.5|TWO_SIDED|95.0|-9.43|18.88||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||18.88|-9.43|0.5
91610134|NCT04063215|183113263|OTHER||Mean Difference (Net)|-9.23||||0.66|TWO_SIDED|95.0|-51.62|33.16||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||33.16|-51.62|0.66
91610135|NCT04063215|183113264|OTHER||Mean Difference (Net)|-26.19||||0.24|TWO_SIDED|95.0|-70.22|17.84||This p-value applies to data regarding 6 months Post-Infusion (Visit 6 - Week 28) compared to Infusion 1/Baseline (Visit 3 - Week 0).|Mixed Models Analysis|||Volumetric MRI measures were analyzed using general linear mixed models (GLMMs) to estimate differences across time points (pre- and post-treatment). Models will include time of assessment (baseline and 6 months after treatment) and baseline age as covariates with random intercepts for participants to account for within-participant correlation. Mean differences with 95% confidence intervals were determined for outcomes at 6 months after treatment.||17.84|-70.22|0.24
91610136|NCT04516967|183113302|SUPERIORITY|||||||0.0077|||||||Fisher Exact|||||||0.0077
91610137|NCT04516967|183113303|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91610138|NCT04516967|183113304|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91610139|NCT04516967|183113305|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91610140|NCT04516967|183113306|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91610141|NCT04516967|183113307|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
91653850|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|3.03||0.0149|TWO_SIDED|95.0|-13.4|-1.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 15||-1.5|-13.4|0.0149
91653851|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.14||0.025|TWO_SIDED|95.0|-13.3|-0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 21||-0.9|-13.3|0.0250
91653852|NCT02978326|183201150|SUPERIORITY||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|2.96||0.0017|TWO_SIDED|95.0|-15.3|-3.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 45||-3.6|-15.3|0.0017
91653853|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1569|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.5|0.1569
91788811|NCT02446743|183457893|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-40.0|||||TWO_SIDED|95.0|-51.8|-25.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.4|-51.8|
91523676|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Baseline AM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.175
91610142|NCT04516967|183113308|SUPERIORITY|||||||0.7175|||||||Fisher Exact|||||||0.7175
91610148|NCT04576949|183113340|SUPERIORITY||Odds Ratio (OR)|8.0|||<|0.0001|TWO_SIDED|95.0|3.94|16.25||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 3 to Week 6||16.25|3.94|< 0.0001
91610149|NCT04576949|183113340|SUPERIORITY||Odds Ratio (OR)|7.3|||<|0.0001|TWO_SIDED|95.0|3.92|14.38||Two-sided, derived from marginal odds ratio|Exact computations||Marginal (unadjusted) odds ratio|||14.38|3.92|<0.0001
91523677|NCT00279201|182923065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
91610150|NCT04576949|183113340|SUPERIORITY||Marginal Difference in Proportions|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.25||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.25|0.16|<0.0001
91610151|NCT04576949|183113341|SUPERIORITY||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.69|11.57||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 9 to Week 12||11.57|3.69|< 0.0001
91610152|NCT04576949|183113341|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.0001|TWO_SIDED|95.0|3.81|11.12||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||11.12|3.81|<0.0001
91613451|NCT04964063|183121265|OTHER||Median Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||ANOVA|||||-0.13|-0.26|<.0001
91613452|NCT04964063|183121266|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.31|-0.18|||ANOVA|||||-0.18|-0.31|<.0001
91613453|NCT04964063|183121268|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.95|-1.45|||ANOVA|||||-1.45|-1.95|<.0001
91610153|NCT04576949|183113341|SUPERIORITY||Marginal Difference in Proportions|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.3||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.30|0.20|<0.0001
91610154|NCT04576949|183113342|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0016|TWO_SIDED|95.0|1.5|10.24||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations|||Abstinence from Week 6 to Week 24|Stratified by site|10.24|1.50|0.0016
91610155|NCT04576949|183113342|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0015|TWO_SIDED|95.0|1.61|9.36||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||9.36|1.61|0.0015
91610156|NCT04576949|183113342|SUPERIORITY||Marginal Difference in Proportions|0.06||||0.0015|TWO_SIDED|95.0|0.03|0.09||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.09|0.03|0.0015
91610157|NCT04576949|183113343|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.0001|TWO_SIDED|95.0|2.81|11.09||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 12 to Week 24||11.09|2.81|< 0.0001
91610158|NCT04576949|183113343|SUPERIORITY||Odds Ratio (OR)|5.31|||<|0.0001|TWO_SIDED|95.0|2.88|10.29||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||10.29|2.88|<0.0001
91610159|NCT04576949|183113343|SUPERIORITY||Marginal Difference in Proportions|0.16|||<|0.0001|TWO_SIDED|95.0|0.11|0.2||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.20|0.11|<.0001
91610160|NCT04576949|183113344|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3484|TWO_SIDED|95.0|0.75|2.33||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Relapse free from Week 6 to Week 24||2.33|0.75|0.3484
91610161|NCT04576949|183113344|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3514|TWO_SIDED|95.0|0.78|2.26||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||2.26|0.78|0.3514
91610162|NCT04576949|183113344|SUPERIORITY|||||||0.0317||||||p-value for homogeneity across sites|Zelen's exact test (Pr ≤ P)|||||||0.0317
91613454|NCT04964063|183121269|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-2.94|-2.44|||ANOVA|||||-2.44|-2.94|<.0001
91613455|NCT04964063|183121270|OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.35|-2.84|||ANOVA|||||-2.84|-3.35|<.0001
91613456|NCT04964063|183121271|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.69|-3.19|||ANOVA|||||-3.19|-3.69|<.0001
91613457|NCT04964063|183121272|OTHER||Median Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.06|-3.55|||ANOVA|||||-3.55|-4.06|<.0001
91653854|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0376|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0376
91653855|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1035|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.6|0.1035
91653856|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.9|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.2|-0.9|0.0037
91788812|NCT02446743|183457893|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.3|9.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.0|-3.3|
91653857|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0061|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.8|0.0061
91653858|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.7878|TWO_SIDED|95.0|-0.4|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.4|0.7878
91653859|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0498|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0498
91710243|NCT00947310|183312957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.58|2.05|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||2.05|0.58|0.80
91653860|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1719|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1719
91710244|NCT00947310|183312958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.34|0.13|<0.001
91710245|NCT00947310|183312958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.4|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||0.40|0.15|<0.001
91710246|NCT00547248|183312959|NON_INFERIORITY|Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature \> 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar.|Difference in percentage|0.89|||||TWO_SIDED|95.0|-4.82|5.59|||Philips' statistical test|||||5.59|-4.82|
91523678|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||P-value is for Baseline midday 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.589
91610173|NCT05642442|183113393|SUPERIORITY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.895|=|0.2363|TWO_SIDED|95.0|-2.83|0.7|||Mixed-effect model with repeat measures|Includes baseline TETRAS score, treatment grp, week, treatment grp and baseline by week, randomization strata, and week repeated for each patient.||||0.70|-2.83|=0.2363
91610174|NCT05642442|183113394|SUPERIORITY||Adjusted difference (%)|14.6|||=|0.0715|TWO_SIDED|95.0|-1.3|30.5|||Cochran-Mantel-Haenszel||Adjusted difference of proportions is the weighted average of differences across strata with the CMH weights. Stratification is based on baseline TETRAS Composite Outcome Score.|||30.5|-1.3|=0.0715
91610175|NCT05642442|183113395|SUPERIORITY||LS Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|1.084|=|0.1232|TWO_SIDED|95.0|-3.82|0.46|||Mixed-effect model with repeat measures|Includes baseline TETRAS-ADL score, treatment grp, week, treatment grp and baseline by week, randomization strata, and week repeated for each patient.||||0.46|-3.82|=0.1232
91610176|NCT05642442|183113396|SUPERIORITY||Adjusted Difference (%)|10.5|||=|0.1906|TWO_SIDED|95.0|-5.2|26.2|||Cochran-Mantel-Haenszel||Adjusted difference of proportions is the weighted average of differences across strata with the CMH weights. Stratification is based on baseline TETRAS Composite Outcome Score.|||26.2|-5.2|=0.1906
91610177|NCT05642442|183113397|SUPERIORITY||Adjusted difference (%)|15.6|||=|0.0052|TWO_SIDED|95.0|4.7|26.6|||Cochran-Mantel-Haenszel||Adjusted difference of proportions is the weighted average of differences across strata with the CMH weights. Stratification is based on baseline TETRAS Composite Outcome Score.|||26.6|4.7|=0.0052
91610178|NCT05642442|183113398|SUPERIORITY||Adjusted Difference (%)|7.6|||=|0.145|TWO_SIDED|95.0|-2.6|17.7|||Cochran-Mantel-Haenszel||Adjusted difference of proportions is the weighted average of differences across strata with the CMH weights. Stratification is based on baseline TETRAS Composite Outcome Score.|||17.7|-2.6|=0.1450
91610179|NCT05642442|183113399|SUPERIORITY||LS Mean Difference|1.37|||=|0.1429|TWO_SIDED|95.0|-0.47|3.2|||Mixed-effect Model With Repeat Measure|Includes baseline TETRAS-PS score, treatment grp, week, treatment grp and baseline by week, randomization strata, and week repeated for each patient.||||3.20|-0.47|=0.1429
91610180|NCT05642442|183113400|SUPERIORITY||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.666|=|0.9739|TWO_SIDED|95.0|-3.35|3.24|||Mixed-effect model with repeat measures|Includes baseline TETRAS score, treatment grp, week, treatment grp and baseline by week, randomization strata, and week repeated for each patient.||||3.24|-3.35|=0.9739
91610181|NCT05642442|183113401|SUPERIORITY||Least square mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.694|=|0.3029|TWO_SIDED|95.0|-2.09|0.65|||Mixed-effect model with repeat measures|Includes baseline MDS-UPDR score, treatment grp, week, treatment grp and baseline by week, randomization strata, and week repeated for each patient.||||0.65|-2.09|=0.3029
91653861|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0161|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.7|0.0161
91653862|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0191|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0191
91653863|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.2537|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.2|0.2537
91653864|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018|TWO_SIDED|95.0|-0.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.2|0.0018
91710247|NCT05133323|183312994|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.89||0.0106|ONE_SIDED|90.0||-0.6|||ANCOVA|||||-0.6||0.0106
91788813|NCT02446743|183457893|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.4|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-2.4|
91653865|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.2878|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.2|0.2878
91653866|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.2594|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.2|0.2594
91653867|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0086|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.3|0.0086
91523679|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Endpoint midday 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.161
91613458|NCT04964063|183121273|OTHER||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.51|-4.0|||ANOVA|||||-4.00|-4.51|<.0001
91610231|NCT03246529|183113625|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),||||||<0.0001
91610232|NCT03246529|183113626|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91653868|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0424|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.6|0.0424
91653869|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0207|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0207
91610233|NCT03246529|183113627|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91710248|NCT00909220|183312997|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED|95.0|0.27|0.49|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).||0.49|0.27|0.05
91653870|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0010
91653871|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0871|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.5|0.0871
91653872|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.568|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45||0.2|-0.4|0.5680
91653873|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0143|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.6|0.0143
91653874|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0063|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.6|0.0063
91653875|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0042|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0042
91653876|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0137|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.6|0.0137
91653877|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0099|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0099
91653878|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0507|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0507
91653879|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0205|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0205
91710249|NCT00909220|183312998|SUPERIORITY|ANCOVA|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|95.0|0.31|0.59|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).||0.59|0.31|<0.05
91788814|NCT02446743|183457893|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-12.4|5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.8|-12.4|
91788815|NCT02446743|183457893|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.2|7.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.7|-2.2|
91523680|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-value is for Baseline PM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.674
91710250|NCT00909220|183312999|OTHER|Multiple regression analyses|beta|0.43|STANDARD_ERROR_OF_MEAN|6.75||0.02|TWO_SIDED|||||p \<0.05 a priori threshold for statistical significance.|Regression, Linear|||||||.02
91788816|NCT02446743|183457893|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|2.8|10.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.5|2.8|
91610255|NCT01582282|183113727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.64||||0.028|||||||ANCOVA|||||||0.028
91610256|NCT01582282|183113727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.72||||0.009|||||||ANCOVA|||||||0.009
91610257|NCT01582282|183113728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.013|||||||ANCOVA|||||||0.013
91610258|NCT01582282|183113728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.003|||||||ANCOVA|||||||0.003
91610259|NCT01582282|183113729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.808|||||||ANCOVA|||||||0.808
91610260|NCT01582282|183113729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.328|||||||ANCOVA|||||||0.328
91653880|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1409|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1409
91653881|NCT02978326|183201151|SUPERIORITY|MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2021|TWO_SIDED|95.0|-0.5|0.1|||Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.5|0.2021
91653882|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0117|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0117
91788817|NCT02446743|183457893|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-17.8|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-17.8|
91610261|NCT01582282|183113730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.508|||||||ANCOVA|||||||0.508
91610262|NCT01582282|183113730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.962|||||||ANCOVA|||||||0.962
91610263|NCT01582282|183113731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.84||||0.363|||||||ANCOVA|||||||0.363
91610264|NCT01582282|183113731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.978|||||||ANCOVA|||||||0.978
91610265|NCT01582282|183113732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.14||||0.785|||||||ANCOVA|||||||0.785
91610266|NCT01582282|183113732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.45||||0.811|||||||ANCOVA|||||||0.811
91610267|NCT00492622|183113733|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||<|0.01||||||\<0.01 is used for determining the level of significance.|paired t-tests|||||||< 0.01
91610268|NCT00492622|183113734|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||||||||||||||P\<0.05 was used as the level of significance with ANOVA for this endpoint.|||
91610269|NCT00492622|183113735|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.||||||0.95||||||An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.|ANOVA|||||||0.95
91610270|NCT04426630|183113736|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||<0.001
91610271|NCT04426630|183113737|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
91610272|NCT04426630|183113738|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
91610273|NCT04426630|183113739|SUPERIORITY|||||||0.028|||||||Chi-squared|Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||0.028
91610274|NCT04426630|183113740|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91610275|NCT04426630|183113741|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91610276|NCT04426630|183113742|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
91610277|NCT04426630|183113743|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91610278|NCT04426630|183113744|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
91610279|NCT04426630|183113745|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
91610280|NCT04426630|183113746|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.07
91610281|NCT04426630|183113747|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91610282|NCT02786537|183113752|SUPERIORITY|Superiority test derived by comparing whether the 95% CI includes zero.|Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.6|0.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|PROD vs. SOF/LDV based regimens as reported in PRO (ALL PATIENTS WHO STARTED TREATMENT BY ARM AS TREATED), population limited to as randomization date of the last PrOD patient start date - RBV FREE REGIMENS||0.3|-3.6|
91610283|NCT02786537|183113752|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method. CI for median derived from PROC QUANTREG.|RBV free EBR/GZR regimen compared to PrOD in consideration that RBV usage was determined by provider and not study randomization.||3.1|-0.4|
91610284|NCT02786537|183113753|SUPERIORITY|Superiority test completed by comparing whether the 95% CI includes zero.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free EBR/GZR regimen vs SOF/LDV (all patients who started treatment by arm as treated)||1.0|-0.6|
91523681|NCT00279201|182923065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
91610285|NCT02786537|183113755|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.0|1.0|||||The comparisons between regimens can be viewed as superiority test, by comparing whether the 95% CI includes zero|Analysis of EBR/GZR vs. SOF/LDV irrespective of RBV usage in consideration that RBV usage was determined by provider and not study randomization.||1.0|0.0|
91613459|NCT01397071|183121276|OTHER||Mean Difference (Final Values)|2.2||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestion||||0.052
91613460|NCT01397071|183121277|OTHER||% of baseline|0.58||||0.03|TWO_SIDED|||||Significance is defined as p\<0.05.|t-test, 2 sided|||Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.||||0.03
91613461|NCT03350750|183121278|SUPERIORITY||ANCOVA Model Effect (Open vs. Closed)|0.22||||0.071|TWO_SIDED|95.0|-0.02|0.46|||ANCOVA||This is the coefficient for an indicator variable comparing the Open versus Closed shunt group, in a linear regression model with Month 4 gait velocity as the outcome and Baseline gait velocity included as a predictor along with treatment.|||0.46|-0.02|0.071
91613462|NCT03350750|183121279|SUPERIORITY|||||||0.337|||||||ANCOVA|||||||0.337
91613463|NCT03350750|183121280|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
91613464|NCT03350750|183121281|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
91613465|NCT03350750|183121282|SUPERIORITY|||||||0.172|||||||ANCOVA|||||||0.172
91613466|NCT03350750|183121283|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.780
91613467|NCT03350750|183121284|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91613468|NCT03350750|183121285|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.240
91613469|NCT03350750|183121286|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
91613470|NCT03350750|183121287|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
91613471|NCT03350750|183121288|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
91613472|NCT03350750|183121289|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
91613473|NCT03350750|183121290|SUPERIORITY|||||||0.235|||||||Fisher Exact|Fisher's exact test with a mid-p-value correction||||||0.235
91613474|NCT00406315|183121295|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.53|||||ONE_SIDED|95.0|||||||A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16.||||
91613475|NCT00406315|183121295|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.33|||||ONE_SIDED|95.0|||||||A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.||||
91613476|NCT00406315|183121296|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-8.48|2.41||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.41|-8.48|
91613477|NCT00406315|183121297|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.2|||||TWO_SIDED|95.0|-1.82|1.44||||||HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||1.44|-1.82|
91613478|NCT00406315|183121297|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.5|||||TWO_SIDED|95.0|-7.07|2.09||||||LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.09|-7.07|
91613479|NCT00406315|183121297|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.6|||||TWO_SIDED|95.0|-16.44|13.15||||||Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||13.15|-16.44|
91613480|NCT00406315|183121298|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.1|||||TWO_SIDED|95.0|-0.02|0.14||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.14|-0.02|
91613481|NCT00406315|183121299|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.0|||||TWO_SIDED|95.0|-0.09|6.15||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.15|-0.09|
91613482|NCT00406315|183121300|SUPERIORITY_OR_OTHER_LEGACY||Mean|134.8|||||TWO_SIDED|95.0|-20.43|289.98||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||289.98|-20.43|
91613483|NCT00406315|183121301|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.9|||||TWO_SIDED|95.0|-5.93|0.11||||||Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-5.93|
91613484|NCT00406315|183121301|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-6.2|0.1||||||Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.10|-6.20|
91613485|NCT00406315|183121302|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.05|||||TWO_SIDED|95.0|-0.32|0.42||||||Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.42|-0.32|
91610286|NCT02786537|183113756|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free SOF/LDV vs. PrOD in consideration that RBV usage was determined by provider and not study randomization and limited RBV sample size.||7.0|-4.2|
91613486|NCT00406315|183121302|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-0.05|
91613487|NCT00406315|183121302|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.01|||||TWO_SIDED|95.0|-0.06|0.07||||||Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.07|-0.06|
91613488|NCT00406315|183121303|SUPERIORITY_OR_OTHER_LEGACY||Mean|-10.22|||||TWO_SIDED|95.0|-12.7|-7.75||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-7.75|-12.70|
91613489|NCT00406315|183121303|SUPERIORITY_OR_OTHER_LEGACY||Mean|-6.61|||||TWO_SIDED|95.0|-8.59|-4.63||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-4.63|-8.59|
91613490|NCT00406315|183121303|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.3|||||TWO_SIDED|95.0|-4.07|-2.53||||||Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.53|-4.07|
91613491|NCT00406315|183121303|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.43|||||TWO_SIDED|95.0|-3.03|-1.83||||||Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.03|
91653883|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5511|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3||0.2|-0.4|0.5511
91653884|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4949|TWO_SIDED|95.0|-0.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.5|0.4949
91653885|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0203|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0203
91653886|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2076|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.2076
91610287|NCT02786537|183113756|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero.|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free PrOD vs. SOF/LDV regimens (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||7.0|-4.2|
91610288|NCT02786537|183113757|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-1.6|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. SOF/LDV (all patients who started treatment by arm as treated)||1.3|-1.6|
91610289|NCT02786537|183113760|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-1.9|5.5|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date). Analysis limited to RBV free regimen in consideration RBV usage determined by provider and not study randomization.||5.5|-1.9|
91610290|NCT02786537|183113760|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.6|2.7|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free SOF/LDV vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||2.7|-4.6|
91610291|NCT02786537|183113761|SUPERIORITY|Superiority test comparison based on presence of zero in 95% CI.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.4|1.6|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis limited to RBV free regimens in consideration that RBV usage determined by provider and not study randomization. All patients who started treatment by arm as treated.||1.6|-1.4|
91610292|NCT02786537|183113764|SUPERIORITY|Superiority test determined by comparing presence of zero in CI.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.9|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free regimens -all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date.||1.3|-9.9|
91610293|NCT02786537|183113764|SUPERIORITY|Superiority comparison by viewing presence of zero in CI.|Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-3.4|9.4||||||RBV free regimens as reported in PRO (all patients who started treatment by arm as treated, population limited to as randomization date of the last PrOD patient start date)||9.4|-3.4|
91653887|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0362|TWO_SIDED|95.0|-0.8|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.8|0.0362
91653888|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3589|TWO_SIDED|95.0|-0.1|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.1|0.3589
91653889|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6991|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.2|0.6991
91610294|NCT02786537|183113766|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.6|2.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free regimens in consideration that RBV usage was determined by provider and not study randomization. Population includes patients who started treatment by arm as treated.||2.1|-3.6|
91610295|NCT02786537|183113775|EQUIVALENCE|Pre-specified equivalence range +/-5%|Mean Difference (Net)|-2.3|||||TWO_SIDED|95.0|-15.3|11.3||||||||11.3|-15.3|
91610296|NCT01466751|183113776|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|8.687||||0.004|TWO_SIDED|||||A-priori threshold for statistical significance: p \< 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.|Mixed Models Analysis|Numerator degrees of freedom=1, Denominator degrees of freedom = 168||A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.||||0.004
91610297|NCT01466751|183113777|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|2.032||||0.156|TWO_SIDED|||||No adjustment for multiple comparisons. The a priori threshold was: p \< 0.05.|Mixed Models Analysis|Numerator degrees of freedom: 1, Denominator degrees of freedom: 168||A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).||||0.156
91610298|NCT02413255|183113786|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0195||||0.465|TWO_SIDED|90.0|0.9752|1.0637|||Power Model|||||1.0637|0.9752|0.465
91610299|NCT02413255|183113787|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.1124||||0.126|TWO_SIDED|90.0|0.9913|1.2336|||Power Model|||Day 1||1.2336|0.9913|0.126
91610300|NCT02413255|183113787|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.09||||0.114|TWO_SIDED|90.0|0.9962|1.1838|||Power Model|||Day 9||1.1838|0.9962|0.114
91610301|NCT02413255|183113788|SUPERIORITY|||||||0.5402|||||||ANOVA|Statistical analysis results were obtained using Analysis of Variance (ANOVA) with dose level as a fixed effect.||||||0.5402
91610302|NCT02413255|183113789|SUPERIORITY|||||||0.7824|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 1||||0.7824
91610303|NCT02413255|183113789|SUPERIORITY|||||||0.4056|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 9||||0.4056
91610304|NCT02413255|183113790|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0606||||0.019|TWO_SIDED|90.0|1.0187|1.1026|||Power Model|||||1.1026|1.0187|0.019
91653890|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9655|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15||0.2|-0.2|0.9655
91653891|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8699|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.2|0.8699
91653892|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3715|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.3715
91653893|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.067|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.4|0.0670
91653894|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0104|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.5|0.0104
91653895|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.5|0.0122
91610305|NCT02413255|183113791|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0789||||0.258|TWO_SIDED|90.0|0.9628|1.195|||Power Model|||Day 1||1.1950|0.9628|0.258
91610306|NCT02413255|183113791|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0929||||0.144|TWO_SIDED|90.0|0.9878|1.198|||Power Model|||Day 9||1.1980|0.9878|0.144
91610307|NCT02413255|183113794|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0799||||0.003|TWO_SIDED|90.0|1.0371|1.1227|||Power Model|||||1.1227|1.0371|0.003
91610308|NCT02413255|183113795|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0897||||0.201|TWO_SIDED|90.0|0.9735|1.206|||Power Model|||||1.2060|0.9735|0.201
91610309|NCT02413255|183113796|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0188||||0.49|TWO_SIDED|90.0|0.9734|1.0642|||Power Model|||||1.0642|0.9734|0.490
91610310|NCT02413255|183113797|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0846||||0.224|TWO_SIDED|90.0|0.969|1.2002|||Power Model|||||1.2002|0.9690|0.224
91610311|NCT02413255|183113804|SUPERIORITY||||||<|0.0001|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||||||<.0001
91610312|NCT02413255|183113820|OTHER||Estimated Ratio|1.121|||||TWO_SIDED|90.0|0.772|1.628||||||||1.628|0.772|
91610313|NCT02413255|183113820|OTHER||Estimated Ratio|1.156|||||TWO_SIDED|90.0|0.796|1.678||||||||1.678|0.796|
91610314|NCT02413255|183113820|OTHER||Estimated Ratio|0.982|||||TWO_SIDED|90.0|0.676|1.425||||||||1.425|0.676|
91610315|NCT02413255|183113820|OTHER||Estimated Ratio|1.055|||||TWO_SIDED|90.0|0.701|1.587||||||||1.587|0.701|
91610316|NCT02413255|183113820|OTHER||Estimated Ratio|1.105|||||TWO_SIDED|90.0|0.761|1.604||||||||1.604|0.761|
91610317|NCT02413255|183113820|OTHER||Estimated Ratio|1.225|||||TWO_SIDED|90.0|0.844|1.778||||||||1.778|0.844|
91610318|NCT00077623|183113821|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.141|||<|0.0001|TWO_SIDED|97.5|-0.098|0.38||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.380|-0.098|<0.0001
91610319|NCT00077623|183113821|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity .|Mean Difference between groups|-0.022|||<|0.0001|TWO_SIDED|97.5|-0.262|0.217||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.217|-0.262|<0.0001
91610320|NCT01334125|183113830|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.903
91610321|NCT01334125|183113831|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|95.0||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.578
91610322|NCT01334125|183113832|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANOVA|||Two way ANOVA comparison of the means of the adiponectin/leptin ratios between the metformin and placebo groups||||0.057
91610323|NCT01334125|183113833|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis for minor hypoglycemia||||1.00
91610324|NCT01334125|183113833|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis of the nocturnal hypoglycemia||||1.00
91610325|NCT00401973|183113858|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|Mixed Models Analysis|Repeated Measures Analysis||To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine \& adjunctive treatment' arm at Week 22.||||0.065
91610326|NCT00401973|183113858|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||Hypothesis=weight gain associated with olanzapine can be prevented or mitigated with an adjunctive pharmacological algorithm.||||0.113
91610327|NCT00401973|183113858|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||||||0.036
91610328|NCT00401973|183113859|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.498
91610329|NCT00401973|183113859|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.637
91610330|NCT00401973|183113859|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.125
91610331|NCT00401973|183113860|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.173
91610332|NCT00401973|183113860|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.016
91610333|NCT00401973|183113860|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.029
91610334|NCT00401973|183113861|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.017
91610335|NCT00401973|183113861|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.015
91610336|NCT00401973|183113861|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.071
91610337|NCT00401973|183113862|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.152
91610338|NCT00401973|183113862|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.350
91610339|NCT00401973|183113862|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.123
91610340|NCT00401973|183113863|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.499
91610341|NCT00401973|183113863|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.833
91610342|NCT00401973|183113863|SUPERIORITY_OR_OTHER|||||||0.339||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.339
91610343|NCT00401973|183113864|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.278
91610344|NCT00401973|183113864|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.976
91610345|NCT00401973|183113864|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.049
91610346|NCT00401973|183113865|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.122
91610347|NCT00401973|183113865|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.225
91653896|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3157|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.3|0.3157
91653897|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0077|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0077
91653898|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.8|0.0078
91653899|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0372|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0372
91653900|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0244|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0244
91610348|NCT00401973|183113865|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.124
91610349|NCT00401973|183113866|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.020
91610350|NCT00401973|183113866|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.037
91610351|NCT00401973|183113866|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.038
91610352|NCT00401973|183113867|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.474
91610353|NCT00401973|183113867|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.404
91610354|NCT00401973|183113867|SUPERIORITY_OR_OTHER|||||||0.652||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.652
91610355|NCT04243369|183113901|OTHER|Only descriptive statistics was provided. The rate and the exact 95% CI of the rate using the Clopper-Pearson Exact method is calculated.|Rate|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100|88.4|
91610356|NCT00320671|183113922|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|56.8||||0.61|TWO_SIDED|95.0|43.9|69.9|||Log Rank||Only the subjects taking risperidone were analysed in this section|||69.9|43.9|.61
91610357|NCT00320671|183113922|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|62.8||||0.61|TWO_SIDED|95.0|50.8|74.8|||Log Rank||Only subjects taking aripiprazole were analysed in this section|||74.8|50.8|.61
91610358|NCT02532543|183113993|SUPERIORITY|||||||0.863|||||||ANOVA|||||||0.863
91610359|NCT02532543|183113994|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.718
91610360|NCT02532543|183113994|SUPERIORITY|||||||0.853|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.853
91610361|NCT02532543|183113995|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group of change in mid buccal bone height||||0.718
91610362|NCT02532543|183113995|SUPERIORITY|||||||0.999|||||||ANOVA|||Comparison between each arm/group of change in mid palatal bone height||||0.999
91610363|NCT02532543|183113995|SUPERIORITY|||||||0.44|||||||ANOVA|||Comparison between each arm/group of change in mesial bone height||||0.440
91610364|NCT02532543|183113995|SUPERIORITY|||||||0.729|||||||ANOVA|||Comparison between each arm/group of change in distal bone height||||0.729
91610365|NCT02532543|183113996|SUPERIORITY|||||||0.613|||||||ANOVA|||||||0.613
91653901|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0993|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.0993
91653902|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0185|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.7|0.0185
91653903|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2471|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2471
91653904|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1076|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.1076
91653905|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2782|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.4|0.2782
91610366|NCT02532543|183113997|SUPERIORITY|||||||0.492|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.492
91610367|NCT02532543|183113997|SUPERIORITY|||||||0.917|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.917
91610368|NCT02532543|183113998|SUPERIORITY|||||||0.353|||||||ANOVA|||Comparison between each arm/group of change in mid buccal soft tissue height||||0.353
91610369|NCT02532543|183113998|SUPERIORITY|||||||0.823|||||||ANOVA|||Comparison between each arm/group of change in mid palatal soft tissue height||||0.823
91610370|NCT02532543|183113998|SUPERIORITY|||||||0.243|||||||ANOVA|||Comparison between each arm/group of change in mesial soft tissue height||||0.243
91610371|NCT02532543|183113998|SUPERIORITY|||||||0.756|||||||ANOVA|||Comparison between each arm/group of change in distal soft tissue height||||0.756
91610372|NCT01144637|183114041|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 2)|1.1012|||||TWO_SIDED|95.0|0.9992|1.2136||||||||1.2136|0.9992|
91610373|NCT01144637|183114041|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 3)|0.9444|||||TWO_SIDED|95.0|0.8554|1.0427||||||||1.0427|0.8554|
91610374|NCT01144637|183114041|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 2 / Group 3)|0.8577|||||TWO_SIDED|95.0|0.7753|0.9488||||||||0.9488|0.7753|
91610375|NCT03472534|183114053|OTHER|The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91610376|NCT00906789|183114073|NON_INFERIORITY_OR_EQUIVALENCE|Given a continuous confidence score (0-100), the trapezoidal method was used to obtain the area under the LROC with bootstrapping at 10,000 iterations to obtain the 95% confidence interval (CI). Acceptance criteria for tests of non-inferiority and superiority were previously set at 95% CI upper bound of ΔAUCUA-SV less than δ=0.1 and δ=0, respectively. If the 95% CI upper bound difference of UA-SV is less than 0.1, then SV is non-inferior. If it is 0 or less than 0, then SV is superior.||||||0.05|||||||Bootstraping|||The sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater. This sample size was calculated using PASS software (Hintze, 2008). Settings: • α = 0.025. • one-sided test • AUCA = 0.80 and AUCSV = 0.90.• 2:1 ratio of patients with nodules to those without • areas calculated for the entire curves • correlation 0.3\* • discrete data. • standard deviation ratios of 1\*.||||0.05
91610377|NCT02334267|183114084|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
91610378|NCT02334267|183114085|SUPERIORITY_OR_OTHER|||||||0.4||||||trend analysis over time|Mixed Models Analysis|||||||0.4
91610379|NCT02334267|183114086|SUPERIORITY_OR_OTHER|||||||0.003||||||trend analysis over time|Mixed Models Analysis|||||||0.003
91610380|NCT02334267|183114087|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
91610381|NCT03237845|183114088|SUPERIORITY||Risk Difference (RD)|7.6||||0.0006|TWO_SIDED|95.0|3.3|11.9|||Cochran-Mantel-Haenszel|||||11.9|3.3|0.0006
91610382|NCT03237845|183114089|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|6.9|17.9|||Cochran-Mantel-Haenszel|||||17.9|6.9|< 0.0001
91653906|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4646|TWO_SIDED|95.0|-0.4|0.2|||Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.4|0.4646
91653907|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.16|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.5|0.1600
91653908|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0474|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0474
91653909|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0446|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0446
91653910|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0093|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0093
91653911|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2998|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.2998
91653912|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0545|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0545
91653913|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2177|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2177
91653914|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.4|0.2300
91653915|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0001
91653916|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0151|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0151
91653917|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0502
91653918|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3659|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.3|0.3659
91653919|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6003|TWO_SIDED|95.0|-0.3|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.3|0.6003
91653920|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0785|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.5|0.0785
91523682|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.201
91653921|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3668|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.3668
91653922|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1827|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.4|0.1827
91653923|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1327|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.1327
91653924|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0993|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.4|0.0993
91523683|NCT00279201|182923065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
91653925|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.6|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.6|0.0002
91653926|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0056|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0056
91653927|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0122
91653928|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1305|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.3|0.1305
91653929|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6638|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.2|0.6638
91653930|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4341|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.2|0.4341
91653931|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9085|TWO_SIDED|95.0|-0.1|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.1|0.9085
91653932|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.182|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.1820
91653933|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.1593|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.1|0.1593
91653934|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.6555|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.1|0.6555
91653935|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.017|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.1|0.0170
91653936|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0188|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.1|0.0188
91788818|NCT02446743|183457893|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|13.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.0|-3.2|
91610383|NCT03237845|183114090|SUPERIORITY||Risk Difference (RD)|15.1|||<|0.0001|TWO_SIDED|95.0|9.4|20.8|||Cochran-Mantel-Haenszel|||||20.8|9.4|< 0.0001
91610384|NCT03237845|183114091|SUPERIORITY||Risk Difference (RD)|9.9||||0.0039|TWO_SIDED|95.0|3.2|16.6|||Cochran-Mantel-Haenszel|||||16.6|3.2|0.0039
91610385|NCT03237845|183114092|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|9.4|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.4|< 0.0001
91610386|NCT03237845|183114093|SUPERIORITY||Risk Difference (RD)|4.8||||0.2084|TWO_SIDED|95.0|-2.7|12.2||P-Value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.2|-2.7|0.2084
91610387|NCT01065428|183114140|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91610388|NCT01065428|183114141|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91653937|NCT02978326|183201151|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0726|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.2|0.0726
91610389|NCT01662999|183114142|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.943|||||TWO_SIDED|90.0|0.867|1.026|||Mixed Models Analysis|||The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.026|0.867|
91610390|NCT01662999|183114143|SUPERIORITY_OR_OTHER||Ration of adjusted geometric mean|0.984|||||TWO_SIDED|90.0|0.961|1.008|||Mixed Models Analysis|||Treatment B versus C in AUC(INF). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.008|0.961|
91610391|NCT01662999|183114145|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.99|||||TWO_SIDED|90.0|0.966|1.014|||Mixed Models Analysis|||Treatment B versus C in AUC(0-T). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.014|0.966|
91610392|NCT01662999|183114147|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.927|||||TWO_SIDED|90.0|0.883|0.972|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||0.972|0.883|
91610393|NCT01662999|183114149|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.055|||||TWO_SIDED|90.0|1.004|1.109|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite of saxagliptin). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.109|1.004|
91610394|NCT01662999|183114150|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.96|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.960|
91610395|NCT01662999|183114151|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.961|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.961|
91610396|NCT01662999|183114152|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
91610397|NCT01662999|183114153|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
91610398|NCT01662999|183114154|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.994|||||TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.030|0.960|
91610399|NCT01662999|183114155|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.046|||||TWO_SIDED|90.0|1.029|1.064|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the AUC(0-T) of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.064|1.029|
91610400|NCT00196937|183114168|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.97|2.29||||||Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.29|-1.97|
91610401|NCT00196937|183114168|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.87|2.03||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.03|-1.87|
91610402|NCT03368404|183114189|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-102 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.34|0.13|||||Treatment difference : CBL-102 - Vismed Multi|||0.13|-1.34|
91610403|NCT03368404|183114190|SUPERIORITY|||||||0.0592||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0592
91610404|NCT03368404|183114191|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
91610405|NCT03368404|183114192|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
91653938|NCT02978326|183201152|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.72||0.0791|TWO_SIDED|95.0|-6.5|0.4||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 3||0.4|-6.5|0.0791
91653939|NCT02978326|183201152|SUPERIORITY||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.86||0.0322|TWO_SIDED|1.86|-7.7|-0.3||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 8||-0.3|-7.7|0.0322
91653940|NCT02978326|183201152|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.91||0.018|TWO_SIDED|95.0|-8.3|-0.8||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 15||-0.8|-8.3|0.0180
91788819|NCT02446743|183457893|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|16.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.5|3.7|
91610406|NCT03368404|183114193|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
91610407|NCT03368404|183114194|SUPERIORITY|||||||0.0176||||||Significance level 0.05|ANCOVA|||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)||||0.0176
91610408|NCT03368404|183114194|SUPERIORITY|||||||0.001||||||Significance level 0.05|ANCOVA|Adjustment to baseline||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)||||0.0010
91610409|NCT03368404|183114195|SUPERIORITY|||||||0.0251||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Daily Activities"||||0.0251
91610410|NCT03368404|183114195|SUPERIORITY|||||||0.0015||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Difficulties with work and handicap"||||0.0015
91610411|NCT03368404|183114195|SUPERIORITY|||||||0.2024||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Giving up makeup"||||0.2024
91610412|NCT03368404|183114195|SUPERIORITY|||||||0.0421||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acknowledgement of the Disease"||||0.0421
91610413|NCT03368404|183114195|SUPERIORITY|||||||0.3945||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acceptance of the disease"||||0.3945
91610414|NCT03368404|183114195|SUPERIORITY|||||||0.0536||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Fear for the Future"||||0.0536
91610415|NCT03368404|183114195|SUPERIORITY|||||||0.1998||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Emotional well-being"||||0.1998
91610416|NCT03368404|183114195|SUPERIORITY|||||||0.0306||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) questions:~Global Question"||||0.0306
91610417|NCT03368404|183114196|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
91610418|NCT03368404|183114197|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
91610419|NCT03368404|183114198|SUPERIORITY|||||||0.0017||||||Significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.0017
91610420|NCT01751646|183114227|OTHER|||||||0.1166||||||P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo|Wilcoxon (Mann-Whitney)|||||||0.1166
91610421|NCT01751646|183114229|OTHER|||||||0.8383|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.8383
91610422|NCT01751646|183114232|OTHER|||||||0.1378|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1378
91610423|NCT01751646|183114234|OTHER|||||||0.4686|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4686
91610424|NCT01751646|183114236|OTHER|||||||0.7601|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.7601
91610425|NCT01751646|183114238|OTHER|||||||0.3978|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.3978
91610426|NCT01751646|183114240|OTHER|||||||0.1187|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1187
91610427|NCT01751646|183114243|OTHER|||||||0.5098|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.5098
91610428|NCT01751646|183114244|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2550
91653941|NCT02978326|183201152|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.92||0.0271|TWO_SIDED|95.0|-8.1|-0.5||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 21||-0.5|-8.1|0.0271
91653942|NCT02978326|183201152|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.82||0.0018|TWO_SIDED|95.0|-9.4|-2.2||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 45||-2.2|-9.4|0.0018
91610429|NCT01751646|183114245|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.6499
91610430|NCT01751646|183114246|OTHER|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2348
91610431|NCT01751646|183114249|OTHER|||||||0.2648|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.2648
91610432|NCT01751646|183114252|OTHER|||||||0.3728|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3728
91610433|NCT01751646|183114255|OTHER|||||||0.7825|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7825
91610434|NCT01751646|183114258|OTHER|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1950
91610435|NCT01751646|183114261|OTHER|||||||0.7127|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7127
91610436|NCT01751646|183114264|OTHER|||||||0.4676|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4676
91610437|NCT01751646|183114267|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0210
91610438|NCT01751646|183114270|OTHER|||||||0.0144|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0144
91610439|NCT01751646|183114273|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||< 0.0001
91610440|NCT01751646|183114276|OTHER|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0814
91610441|NCT01751646|183114279|OTHER|||||||0.4808|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4808
91610442|NCT01751646|183114282|OTHER|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3870
91610443|NCT01751646|183114285|OTHER|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4290
91610444|NCT01751646|183114286|OTHER|||||||0.9186|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.9186
91610445|NCT01751646|183114287|OTHER|||||||0.4016|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4016
91610446|NCT01751646|183114288|OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.5810
91610447|NCT01751646|183114289|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1570
91610448|NCT01751646|183114295|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to week 48||||<0.0001
91610449|NCT01751646|183114295|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to Week 48||||<0.0001
91523684|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.956||95.0||||P-value is for Baseline mean of all 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.956
91788820|NCT02446743|183457893|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-11.8|11.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.0|-11.8|
91788821|NCT02446743|183457893|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-4.6|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-4.6|
91610450|NCT01751646|183114298|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
91610451|NCT01751646|183114298|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
91610452|NCT01151137|183114313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.294||||0.0019|TWO_SIDED|95.0|1.337|3.936||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for stroke, systemic arterial embolism, myocardial infarction or cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||3.936|1.337|0.0019
91653943|NCT02978326|183201153|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3372|TWO_SIDED|95.0|0.7|2.81||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 3||2.81|0.70|0.3372
91653944|NCT02978326|183201153|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0935|TWO_SIDED|95.0|0.91|3.47||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 8||3.47|0.91|0.0935
91653945|NCT02978326|183201153|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0276|TWO_SIDED|95.0|1.09|4.28||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 15||4.28|1.09|0.0276
91610453|NCT01151137|183114314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.947|||<|0.0001|TWO_SIDED|95.0|1.448|2.617||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for unscheduled cardiovascular hospitalization or death from any cause~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||2.617|1.448|<0.0001
91610454|NCT01151137|183114316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.115||||0.046|TWO_SIDED|95.0|0.996|4.49||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||4.490|0.996|0.0460
91610455|NCT02973815|183114319|OTHER||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.065||0.342|TWO_SIDED|95.0|-0.194|0.067|||Regression, Linear|||This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistance||0.067|-0.194|0.342
91788822|NCT02446743|183457893|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-0.8|9.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-0.8|
91788823|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-45.0|||||TWO_SIDED|95.0|-54.4|-34.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-34.3|-54.4|
91523685|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value is for Endpoint mean of all 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.019
91788824|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.5|5.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.2|-4.5|
91610456|NCT02973815|183114320|OTHER||Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.73104||0.09|TWO_SIDED|95.0|-0.2|2.71|||Regression, Linear|||Adjusted for: baseline HFI Fruit value, and economic assistance status||2.71|-0.20|0.09
91610457|NCT02973815|183114321|OTHER||Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|0.61||0.047|TWO_SIDED|95.0|0.02|2.44|||Regression, Linear|||Adjusted for: baseline HFI Vegetable value, and economic assistance status||2.44|0.02|0.047
91788825|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.9|3.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.9|-1.9|
91610458|NCT02973815|183114322|OTHER||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|0.08|0.88|||Regression, Linear|||Adjusted for: baseline healthfulness score and economic assistance status||0.88|0.08|0.019
91610459|NCT02973815|183114323|OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.218|TWO_SIDED|95.0|-0.4|0.09|||Regression, Linear|||Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.09|-0.4|0.218
91610460|NCT02973815|183114324|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.2||0.066|TWO_SIDED|95.0|-0.03|0.77|||Regression, Linear|||Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.77|-0.03|0.066
91610461|NCT02973815|183114325|OTHER||Mean Difference (Net)|-4.79|STANDARD_ERROR_OF_MEAN|4.41||0.28|TWO_SIDED|95.0|-13.56|3.98|||Regression, Linear|||Adjusted for: baseline MVPA, child age (baseline), and child sex||3.98|-13.56|0.28
91610462|NCT02973815|183114326|OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.928|TWO_SIDED|95.0|-0.31|0.34|||Regression, Linear|||Adjusted for: baseline screentime, child age (baseline), and child sex||0.34|-0.31|0.928
91610463|NCT03478683|183114329|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.0143|||TWO_SIDED|95.0|-0.013|0.043|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.043|-0.013|
91610464|NCT03478683|183114330|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0139||0.481|TWO_SIDED|95.0|-0.037|0.018||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.018|-0.037|0.481
91610465|NCT03478683|183114330|SUPERIORITY||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.0124|<|0.001|TWO_SIDED|95.0|0.037|0.086||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.086|0.037|<0.001
91653946|NCT02978326|183201153|SUPERIORITY||Odds Ratio (OR)|1.79||||0.092|TWO_SIDED|95.0|0.91|3.54||Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 21||3.54|0.91|0.0920
91788826|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-48.0|||||TWO_SIDED|95.0|-60.8|-32.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-32.0|-60.8|
91610466|NCT03478683|183114330|SUPERIORITY||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0133|<|0.001|TWO_SIDED|95.0|0.032|0.084||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.084|0.032|<0.001
91610467|NCT03478683|183114330|SUPERIORITY||Mean Difference (Net)|0.038|STANDARD_ERROR_OF_MEAN|0.014||0.007|TWO_SIDED|95.0|0.01|0.066||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.066|0.010|0.007
91610468|NCT03478683|183114331|SUPERIORITY||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.011||0.415|TWO_SIDED|95.0|-0.03|0.013||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.013|-0.030|0.415
91610469|NCT03478683|183114332|SUPERIORITY||Mean Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.0138||0.335|TWO_SIDED|95.0|-0.014|0.04||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.040|-0.014|0.335
91788827|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.3|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-7.3|
91610470|NCT03037905|183114349|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.2|TWO_SIDED|95.0|-17.1|3.7|||Mixed Models Analysis|||||3.7|-17.1|0.20
91653947|NCT02978326|183201153|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1109|TWO_SIDED|95.0|0.88|3.51||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 45||3.51|0.88|0.1109
91653948|NCT02978326|183201154|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.29||0.0169|TWO_SIDED|95.0|-5.7|-0.6||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 3||-0.6|-5.7|0.0169
91653949|NCT02978326|183201154|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.32||0.001|TWO_SIDED|95.0|-7.0|-1.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 8||-1.8|-7.0|0.0010
91610471|NCT03037905|183114350|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.6|TWO_SIDED|95.0|-5.9|10.3|||Mixed Models Analysis|||||10.3|-5.9|0.60
91610472|NCT03037905|183114351|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.0|5.1|||Mixed Models Analysis|||||5.1|-7.0|.76
91610473|NCT03037905|183114352|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||.83
91610474|NCT02273973|183114370|SUPERIORITY||Difference in Response Rates|10.71||||0.049|TWO_SIDED|95.0|0.11|21.32|||Cochran-Mantel-Haenszel|||||21.32|0.11|0.0490
91653950|NCT02978326|183201154|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.41||0.0063|TWO_SIDED|95.0|-6.7|-1.1||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 15||-1.1|-6.7|0.0063
91788828|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
91610475|NCT02273973|183114371|SUPERIORITY||Difference in Response Rates|1.21||||0.3698|TWO_SIDED|95.0|-1.12|3.55|||Fisher Exact|||||3.55|-1.12|0.3698
91610476|NCT02273973|183114372|SUPERIORITY||Difference in Response Rates|18.19||||0.0332|TWO_SIDED|95.0|2.57|33.81|||Cochran-Mantel-Haenszel|||||33.81|2.57|0.0332
91610477|NCT02273973|183114373|SUPERIORITY||Difference in Response Rates|1.37||||0.4803|TWO_SIDED|95.0|-1.3|4.04|||Fisher Exact|||||4.04|-1.30|0.4803
91610478|NCT02273973|183114374|SUPERIORITY||Difference in Response Rates|5.2||||0.5017|TWO_SIDED|95.0|-9.2|19.61|||Cochran-Mantel-Haenszel|||||19.61|-9.20|0.5017
91610479|NCT02273973|183114375|SUPERIORITY||Difference in Response Rates|1.05||||1|TWO_SIDED|95.0|-2.65|4.75|||Fisher Exact|||||4.75|-2.65|1.0000
91610480|NCT02273973|183114376|SUPERIORITY||Difference in Response Rates|21.14||||0.0115|TWO_SIDED|95.0|5.59|36.68|||Cochran-Mantel-Haenszel|||||36.68|5.59|0.0115
91610481|NCT02273973|183114377|SUPERIORITY||Difference in Response Rates|2.66||||0.7928|TWO_SIDED|95.0|-11.88|17.2|||Cochran-Mantel-Haenszel|||||17.20|-11.88|0.7928
91610482|NCT02273973|183114378|SUPERIORITY||Difference in Response Rates|9.45||||0.2659|TWO_SIDED|95.0|-5.8|24.7|||Cochran-Mantel-Haenszel|||||24.70|-5.80|0.2659
91610483|NCT02273973|183114379|SUPERIORITY||Difference in Response Rates|7.63||||0.3299|TWO_SIDED|95.0|-6.34|21.6|||Cochran-Mantel-Haenszel|||||21.60|-6.34|0.3299
91610484|NCT02273973|183114380|SUPERIORITY||Difference in Response Rates|10.68||||0.1554|TWO_SIDED|95.0|-3.96|25.32|||Cochran-Mantel-Haenszel|||||25.32|-3.96|0.1554
91610485|NCT02273973|183114381|SUPERIORITY||Difference in Response Rates|2.41||||0.787|TWO_SIDED|95.0|-11.82|16.63|||Cochran-Mantel-Haenszel|||||16.63|-11.82|0.7870
91610486|NCT02273973|183114382|SUPERIORITY||Ratio of Least square mean|0.83||||0.117|TWO_SIDED|95.0|0.65|1.05|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Week 3.||1.05|0.65|0.117
91610487|NCT02273973|183114382|SUPERIORITY||Ratio of Least square mean|1.25||||0.105|TWO_SIDED|95.0|0.95|1.65|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Surgery.||1.65|0.95|0.105
91610488|NCT02273973|183114384|SUPERIORITY||Least squares mean difference|-13.32||||0.002|TWO_SIDED|95.0|-21.67|-4.96|||Regression, Linear|||||-4.96|-21.67|0.002
91610489|NCT02104180|183114390|NON_INFERIORITY|An estimate of the difference between the pain felt by patient during the two dressings removals along with a 95% confidence interval (CI) has been derived. If the upper limit of the confidence interval was less than 13 mm, clinical non-inferiority of Tulle Gras versus Urgotul has been demonstrated.|Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-1.339|1.864|||||The pain intensity has been analyzed using analysis of variance (ANOVA). The model for this cross-over study included sequence, period and treatment as fixed effects and subject within sequence as random effect.|||1.864|-1.339|
91610490|NCT01676116|183114391|SUPERIORITY_OR_OTHER||Treatment contrast|-0.94|||<|0.001|TWO_SIDED|95.0|-1.11|-0.78|||ANCOVA|||||-0.78|-1.11|<0.001
91610491|NCT01821677|183114409|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
91610492|NCT01821677|183114409|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
91610493|NCT01821677|183114409|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
91610494|NCT01821677|183114410|SUPERIORITY|||||||0.42|||||||ANCOVA|||||||0.42
91610495|NCT01821677|183114410|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
91610496|NCT01821677|183114410|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
91610497|NCT03461965|183114415|OTHER|p-value \< 0.05 was considered statistically significant||||||0.007|||||||t-test, 2 sided|||Comparing total responses that were correct across all participants in both arms||||0.007
91610498|NCT03461965|183114416|OTHER|p-value \< 0.05 was considered statistically significant||||||0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.0001
91610499|NCT03461965|183114416|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.03
91610500|NCT03461965|183114416|OTHER|p-value \< 0.05 was considered statistically significant||||||0.352|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.352
91610501|NCT03461965|183114417|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
91610502|NCT03461965|183114417|OTHER|p-value \< 0.05 was considered statistically significant||||||0.04|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.04
91710824|NCT02504320|183314063|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0848|||||TWO_SIDED|90.0|0.9528|1.235|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.2350|0.9528|
91610503|NCT03461965|183114417|OTHER|p-value \< 0.05 was considered statistically significant||||||0.052|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.052
91610504|NCT03461965|183114418|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
91523686|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Baseline mean all premeal.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.445
91610505|NCT03461965|183114418|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
91610506|NCT03461965|183114418|OTHER|p-value \< 0.05 was considered statistically significant||||||0.208|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.208
91610507|NCT03461965|183114419|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||Chi-squared|||||||<0.03
91610508|NCT02680301|183114422|EQUIVALENCE|Wilcoxon sign- rank test values with ranks from change in cream efficacy ratings minus change in ointment efficacy ratings.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91610509|NCT00538642|183114429|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91610510|NCT05278104|183114457|OTHER|No formal hypothesis was tested.|Least square mean difference|-0.4|||||TWO_SIDED|95.0|-2.6|1.7|||ANCOVA||The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.|Change from baseline was analyzed with an ANCOVA model with the BIS-11 score at baseline as covariate and treatment as fixed factor.||1.7|-2.6|
91610511|NCT05278104|183114458|OTHER|No formal hypothesis was tested.|Least square mean difference|-2.2|||||TWO_SIDED|95.0|-4.6|0.3|||ANCOVA||The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.|Change from baseline was analyzed with an ANCOVA model with the BIS-11 score at baseline as covariate and treatment as fixed factor.||0.3|-4.6|
91610512|NCT05278104|183114459|OTHER|No formal hypothesis was tested.|Least square mean|0.2|||||TWO_SIDED|95.0|-2.1|2.4|||||The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.|Change from baseline was analyzed with an ANCOVA model with the S-UPPS-P score at baseline as covariate and treatment as fixed factor.||2.4|-2.1|
91610513|NCT05278104|183114460|OTHER|No formal hypothesis was tested.|Least square mean difference|0.9|||||TWO_SIDED|95.0|-1.3|3.1|||ANCOVA||The treatment effect was estimated regardless of concomitant/rescue medication use or nausea/vomiting (treatment policy). Treatment discontinuation was handled with a while-on-treatment strategy.|Change from baseline was analyzed with an ANCOVA model with the S-UPPS-P score at baseline as covariate and treatment as fixed factor.||3.1|-1.3|
91610514|NCT01269125|183114467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|STANDARD_ERROR_OF_MEAN|0.0||0.8|TWO_SIDED|95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
91610515|NCT01269125|183114471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.05|STANDARD_ERROR_OF_MEAN|0.0||0.8||95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
91610516|NCT01269125|183114471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.48||95.0|-0.4|0.2|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.2|-0.4|0.48
91613492|NCT00406315|183121303|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.67|||||TWO_SIDED|95.0|-2.36|-0.99||||||Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.36|
91613493|NCT00406315|183121303|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.92|||||TWO_SIDED|95.0|-1.48|-0.35||||||Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.35|-1.48|
91610517|NCT01269125|183114471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.15|STANDARD_ERROR_OF_MEAN|0.0||0.22||95.0|-0.4|0.1|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.1|-0.4|0.22
91610518|NCT01040832|183114472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.793|TWO_SIDED|95.0|0.7|1.6|||Stratified log rank|||||1.6|0.7|0.793
91610519|NCT01040832|183114473|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Cochran-Mantel-Haenszel|||||||>0.999
91610520|NCT01040832|183114474|SUPERIORITY_OR_OTHER|||||||0.557||95.0|||||Cochran-Mantel-Haenszel|||||||0.557
91610521|NCT00151411|183114477|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.54|TWO_SIDED|95.0|-9.9|18.4|||Mixed Models Analysis|||||18.4|-9.9|0.54
91610522|NCT00151411|183114478|SUPERIORITY||Rate Ratio|2.5||||0.07|TWO_SIDED|95.0|0.9|6.6|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the probability of ovulation.||6.6|0.9|0.07
91610523|NCT00151411|183114478|SUPERIORITY||rate ratio|1.2||||0.51|TWO_SIDED|95.0|0.7|1.9|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the count of ovulations provided a woman actually ovulated.||1.9|0.7|0.51
91653951|NCT02978326|183201154|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.37||0.0119|TWO_SIDED|95.0|-6.2|-0.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 21||-0.8|-6.2|0.0119
91653952|NCT02978326|183201154|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.28||0.0002|TWO_SIDED|95.0|-7.5|-2.4||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 45||-2.4|-7.5|0.0002
91653953|NCT02978326|183201155|SUPERIORITY||Odds Ratio (OR)|1.75||||0.1145|TWO_SIDED|95.0|0.87|3.53||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 3||3.53|0.87|0.1145
91653954|NCT02978326|183201155|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1069|TWO_SIDED|95.0|0.89|3.3||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 8||3.30|0.89|0.1069
91610524|NCT00151411|183114479|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.05|TWO_SIDED|95.0|0.1|9.0|||Mixed Models Analysis|||||9.0|0.1|0.05
91523687|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Endpoint mean all premeal.|ANOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.371
91610525|NCT00417612|183114480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
91610526|NCT03351244|183114543|OTHER||Hazard Ratio (HR)|1.097||||0.7735|TWO_SIDED|95.0|0.585|2.056|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.056|0.585|0.7735
91610527|NCT03351244|183114543|OTHER||Hazard Ratio (HR)|0.91||||0.7809|TWO_SIDED|95.0|0.468|1.77|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.770|0.468|0.7809
91610528|NCT03351244|183114543|OTHER||Hazard Ratio (HR)|1.005||||0.9862|TWO_SIDED|95.0|0.576|1.753|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.753|0.576|0.9862
91610529|NCT03351244|183114544|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.38||||0.5289|TWO_SIDED|95.0|-0.809|1.57|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.570|-0.809|0.5289
91610530|NCT03351244|183114544|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.21||||0.744|TWO_SIDED|95.0|-1.055|1.475|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.475|-1.055|0.7440
91653955|NCT02978326|183201155|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0045|TWO_SIDED|95.0|1.36|5.27||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 15||5.27|1.36|0.0045
91610531|NCT03351244|183114544|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.31||||0.5659|TWO_SIDED|95.0|-0.745|1.358|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.358|-0.745|0.5659
91610532|NCT03351244|183114547|OTHER||Hazard Ratio (HR)|1.006||||0.9938|TWO_SIDED|95.0|0.203|4.989|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.989|0.203|0.9938
91610533|NCT03351244|183114547|OTHER||Hazard Ratio (HR)|1.116||||0.893|TWO_SIDED|95.0|0.225|5.531|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||5.531|0.225|0.8930
91610534|NCT03351244|183114547|OTHER||Hazard Ratio (HR)|1.058||||0.936|TWO_SIDED|95.0|0.265|4.233|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.233|0.265|0.9360
91610535|NCT03351244|183114549|OTHER||Hazard Ratio (HR)|0.788||||0.6362|TWO_SIDED|95.0|0.293|2.118|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.118|0.293|0.6362
91610536|NCT03351244|183114549|OTHER||Hazard Ratio (HR)|0.612||||0.3782|TWO_SIDED|95.0|0.205|1.826|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.826|0.205|0.3782
91610537|NCT03351244|183114549|OTHER||Hazard Ratio (HR)|0.703||||0.4253|TWO_SIDED|95.0|0.296|1.671|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.671|0.296|0.4253
91610538|NCT01165229|183114560|OTHER|The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.|Vaccine efficacy|90.02|||<|0.0001|TWO_SIDED|95.0|83.54|94.32|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.||94.32|83.54|<0.0001
91610539|NCT01165229|183114560|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.08|||<|0.0001|TWO_SIDED|95.0|74.65|96.16|||Poisson exact method|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo \>=80YOA Group||96.16|74.65|<0.0001
91610540|NCT01165229|183114560|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.79|||<|0.0001|TWO_SIDED|95.0|84.29|93.66|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||93.66|84.29|<0.0001
91613494|NCT00406315|183121304|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.76|||||TWO_SIDED|95.0|-0.9|-0.61||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.61|-0.90|
91613495|NCT00406315|183121304|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.36|-0.58|
91613496|NCT00406315|183121305|SUPERIORITY_OR_OTHER_LEGACY||Mean|2.7|||||TWO_SIDED|95.0|2.52|2.88||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.88|2.52|
91613497|NCT00406315|183121305|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.2|||||TWO_SIDED|95.0|3.02|3.34||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||3.34|3.02|
91613498|NCT00406315|183121306|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.55|||||TWO_SIDED|95.0|-3.27|-1.83||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.27|
91613499|NCT00406315|183121306|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.58|||||TWO_SIDED|95.0|-2.16|-0.99||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.16|
91613500|NCT00406315|183121307|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.61|||||TWO_SIDED|95.0|-5.95|-3.26||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-3.26|-5.95|
91613501|NCT00406315|183121307|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.21|||||TWO_SIDED|95.0|-5.57|-2.85||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.85|-5.57|
91613502|NCT00406315|183121307|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.02|||||TWO_SIDED|95.0|-1.31|-0.73||||||Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.73|-1.31|
91613503|NCT00406315|183121307|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.88|||||TWO_SIDED|95.0|-1.13|-0.63||||||Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.63|-1.13|
91610541|NCT01165229|183114561|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|93.04|||<|0.0001|TWO_SIDED|95.0|72.47|99.19|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||99.19|72.47|<0.0001
91610542|NCT01165229|183114561|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|71.16||||0.1844|TWO_SIDED|95.0|-51.51|97.08|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||97.08|-51.51|0.1844
91610543|NCT01165229|183114561|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|88.78|||<|0.0001|TWO_SIDED|95.0|68.7|97.1|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=70YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||97.10|68.70|<0.0001
91610544|NCT01165229|183114562|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.27|||<|0.0001|TWO_SIDED|95.0|86.04|94.85|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||94.85|86.04|<0.0001
91610545|NCT01165229|183114562|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.37|||<|0.0001|TWO_SIDED|95.0|80.22|96.94|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||96.94|80.22|<0.0001
91610546|NCT01165229|183114562|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.3|||<|0.0001|TWO_SIDED|95.0|86.88|94.46|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||94.46|86.88|<0.0001
91613504|NCT00406315|183121308|SUPERIORITY_OR_OTHER_LEGACY||Mean|7.88|||||TWO_SIDED|95.0|6.07|9.69||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.69|6.07|
91613505|NCT00406315|183121308|SUPERIORITY_OR_OTHER_LEGACY||Mean|5.27|||||TWO_SIDED|95.0|3.89|6.65||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.65|3.89|
91653956|NCT02978326|183201155|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0421|TWO_SIDED|95.0|1.03|3.93||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 21||3.93|1.03|0.0421
91653957|NCT02978326|183201155|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0541|TWO_SIDED|95.0|0.99|4.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 45||4.03|0.99|0.0541
91653958|NCT02978326|183201156|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0326|TWO_SIDED|95.0|1.09|7.38||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 3||7.38|1.09|0.0326
91610547|NCT01165229|183114563|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|90.8|||<|0.0001|TWO_SIDED|95.0|62.57|98.95|||Poisson exact test|||Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group||98.95|62.57|<0.0001
91610548|NCT01165229|183114563|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|65.76||||0.3072|TWO_SIDED|95.0|-91.58|96.62|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||96.62|-91.58|0.3072
91610549|NCT01165229|183114563|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|85.49|||<|0.0001|TWO_SIDED|95.0|58.52|96.3|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||96.30|58.52|<0.0001
91613506|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
91613507|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
91613508|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
91653959|NCT02978326|183201156|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3749|TWO_SIDED|95.0|0.68|2.79||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 8||2.79|0.68|0.3749
91653960|NCT02978326|183201156|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0087|TWO_SIDED|95.0|1.26|4.92||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 15||4.92|1.26|0.0087
91653961|NCT02978326|183201156|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0257|TWO_SIDED|95.0|1.1|4.31||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 21||4.31|1.10|0.0257
91710251|NCT00909220|183313000|OTHER|Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.|Slope|2.58|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED|95.0|1.22|2.77||The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.|Regression, Logistic|df = 31||A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.||2.77|1.22|<0.05
91523688|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Baseline combined AM/PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.848
91610550|NCT01165229|183114564|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|21.7||||0.3749|TWO_SIDED|95.0|-34.4|54.39|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||54.39|-34.40|0.3749
91610551|NCT01165229|183114564|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|51.76||||0.2466|TWO_SIDED|95.0|-65.55|85.95|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo\>=80YOA Group||85.95|-65.55|0.2466
91653962|NCT02978326|183201156|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0339|TWO_SIDED|95.0|1.06|4.09||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 45||4.09|1.06|0.0339
91610552|NCT01165229|183114564|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|28.4||||0.1877|TWO_SIDED|95.0|-17.69|56.44|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo\>=70YOA Group||56.44|-17.69|0.1877
91523689|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Endpoint combined AM/PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.002
91610553|NCT01165229|183114567|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.2533|TWO_SIDED|95.0|-144.13|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||100.00|-144.13|0.2533
91610554|NCT01165229|183114567|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.5024|TWO_SIDED|95.0|-435.14|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-435.14|0.5024
91610555|NCT01165229|183114567|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.0636|TWO_SIDED|95.0|-9.92|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||100.00|-9.92|0.0636
91610556|NCT01165229|183114568|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.|Vaccine efficacy|-65.69||||0.4947|TWO_SIDED|95.0|-827.06|73.62|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||73.62|-827.06|0.4947
91610557|NCT01165229|183114568|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-558.05|100.0|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-558.05|1.0000
91610558|NCT01165229|183114568|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|0.97||||1|TWO_SIDED|95.0|-433.32|83.16|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||83.16|-433.32|1.0000
91610559|NCT01165229|183114569|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|43.42||||0.0112|TWO_SIDED|95.0|10.77|70.53|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||70.53|10.77|0.0112
91610560|NCT01165229|183114569|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%|Vaccine efficacy|27.03||||0.3903|TWO_SIDED|95.0|-26.43|73.2|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||73.20|-26.43|0.3903
91610561|NCT01165229|183114569|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|39.6||||0.0083|TWO_SIDED|95.0|10.79|64.75|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=70YOA group and Zoster-022 Placebo \>=70YOA Group||64.75|10.79|0.0083
91613509|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
91523690|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value is for Baseline AM/PM 2hr postprandial excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.281
91523691|NCT00279201|182923065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM/PM 2hr postprandial excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
91610562|NCT01165229|183114570|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|58.94||||0.0232|TWO_SIDED|95.0|11.45|80.96|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||80.96|11.45|0.0232
91610563|NCT01165229|183114570|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|-14.56||||0.8324|TWO_SIDED|95.0|-303.3|67.46|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||67.46|-303.30|0.8324
91610564|NCT01165229|183114570|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|49.25||||0.0404|TWO_SIDED|95.0|2.92|73.47|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||73.47|2.92|0.0404
91610565|NCT01165229|183114579|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.88|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.||100.00|40.88|0.0081
91610566|NCT01165229|183114579|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.83|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group||100.00|-442.83|0.5097
91710252|NCT04152083|183313006|OTHER||Hazard Ratio (HR)|1.54||||0.0006|TWO_SIDED|95.0|1.2|1.98||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% confidence interval (CI) were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||1.98|1.20|0.0006
91710253|NCT04152083|183313007|OTHER||Hazard Ratio (HR)|1.75|||<|0.0001|TWO_SIDED|95.0|1.41|2.19||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% CI were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||2.19|1.41|<0.0001
91710254|NCT04152083|183313008|OTHER||Odds Ratio (OR)|2.27||||0.0009|TWO_SIDED|95.0|1.39|3.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on Cochran-Mantel-Haenszel (CMH) test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.72|1.39|0.0009
91710255|NCT04152083|183313009|OTHER||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.55|3.25||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on CMH test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.25|1.55|<0.0001
91788829|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-41.0|||||TWO_SIDED|95.0|-53.3|-25.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.5|-53.3|
91788830|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.8|8.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.1|-4.8|
91610567|NCT01165229|183114580|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-649.86|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group||100.00|-649.86|1.0000
91610568|NCT01165229|183114580|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-3938.7|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group||100.00|-3938.70|1.0000
91610569|NCT01165229|183114580|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|21.6||||1|TWO_SIDED|95.0|-149.41|78.91|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group||78.91|-149.41|1.0000
91610570|NCT01165229|183114580|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|-223.81||||0.1528|TWO_SIDED|95.0|-883.05|18.84|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=80 YOA Group versus Zoster-022/006 Pooled Placebo\>=80 YOA Group||18.84|-883.05|0.1528
91610571|NCT01165229|183114580|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|0.29||||0.5417|TWO_SIDED|95.0|-161.53|65.57|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=50 YOA Group versus Zoster-022/006 Pooled Placebo \>=50 YOA Group||65.57|-161.53|0.5417
91613510|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
91710256|NCT03318003|183313022|SUPERIORITY||Pearson Chi Square|0.76||||0.92|TWO_SIDED|||||no adjustments made|Chi-squared|||||||0.92
91710257|NCT04819438|183313044|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of Cmax geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|117.05|||<|0.0001|TWO_SIDED|90.0|110.43|124.06|||ANOVA|||||124.06|110.43|<0.0001
91710258|NCT04819438|183313045|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-t geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.82|||<|0.0001|TWO_SIDED|90.0|108.25|115.5|||ANOVA|||||115.50|108.25|<0.0001
91710259|NCT04819438|183313047|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-∞ geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.83|||<|0.0001|TWO_SIDED|90.0|108.19|115.29|||ANOVA|||||115.29|108.19|<0.0001
91710260|NCT04607135|183313056|OTHER|||||||0.0003||||||F-statistic = 11.71|Welch's ANOVA|||||||0.0003
91710261|NCT04607135|183313056|OTHER|||||||0.002||||||q-statistic = 6.74|Games-Howell post-hoc test|||||||0.002
91710262|NCT04607135|183313056|OTHER|||||||0.24||||||q-statistic = 2.34|Games-Howell post-hoc test|||||||0.24
91653963|NCT04309474|183201186|OTHER|A statistical test was not performed.|Area under the curve (AUC)|0.71|||||TWO_SIDED|95.0|-0.764|2.175|||||"AUC analyses based on trapezoidal rule using contrast derived from MMRM with stratification factors, treatment, visit, and a treatment by visit interaction included in the model.~Posterior probability that the difference in AUC exceeds 0.6 = 0.557"|||2.175|-0.764|
91653964|NCT04309474|183201187|OTHER|A statistical test was not performed.|Odds Ratio of LS Means|1.74|||||TWO_SIDED|95.0|0.71|4.24|||||Point estimate for responder rate (defined as having an mRS score of 0, 1, or 2), odds ratio and 95% confidence intervals based on a generalized linear mixed model (GLMM).|||4.24|0.71|
91653965|NCT02974153|183201194|SUPERIORITY||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-3.45|-1.74|||ANCOVA|||||-1.74|-3.45|<0.0001
91653966|NCT02974153|183201194|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-2.88|-1.18|||ANCOVA|||||-1.18|-2.88|<0.0001
91788831|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-0.6|7.8|||Miettinen and Nurminen score methodx|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-0.6|
91523692|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||P-value is for Baseline mean all blood glucose values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.588
91788832|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.9|4.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.6|-15.9|
91788833|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
91788834|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
91788835|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|10.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.3|-19.2|
91788836|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
91788837|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
91788838|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.4|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.4|
91788839|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
91788840|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
91788841|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-26.0|||||TWO_SIDED|95.0|-36.6|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||-15.7|-36.6|
91788842|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-13.3|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-13.3|
91788843|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|21.0|||||TWO_SIDED|95.0|12.8|28.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.3|12.8|
91788844|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-18.0|||||TWO_SIDED|95.0|-32.5|-5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-5.8|-32.5|
91610572|NCT01165229|183114581|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|23.75||||0.2885|TWO_SIDED|95.0|-25.8|53.78|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group||53.78|-25.80|0.2885
91610573|NCT01165229|183114581|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|54.93||||0.194|TWO_SIDED|95.0|-50.03|86.46|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=80 YOA Group and Zoster-022/006 pooled Placebo \>=80 YOA Group||86.46|-50.03|0.1940
91613511|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
91610574|NCT01165229|183114581|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|30.48||||0.1243|TWO_SIDED|95.0|-10.52|56.27|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 pooled Placebo\>=70 YOA Group||56.27|-10.52|0.1243
91610575|NCT01873950|183114630|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
91610576|NCT01873950|183114631|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
91610577|NCT01873950|183114632|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
91610578|NCT01745055|183114665|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|103.06|||||TWO_SIDED|90.0|99.0|107.29||||||Natural log transformed, AUC (0-12) of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.29|99.00|
91610579|NCT01745055|183114666|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|93.79|112.47||||||Natural log transformed, Cmax of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.47|93.79|
91610580|NCT01745055|183114667|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|89.53|||||TWO_SIDED|90.0|77.38|103.57||||||Natural log transformed, AUClast of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||103.57|77.38|
91610581|NCT01745055|183114668|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|87.25|||||TWO_SIDED|90.0|76.03|100.12||||||Natural log transformed, Cmax of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.12|76.03|
91653967|NCT02974153|183201195|SUPERIORITY||Mean Difference (Final Values)|18.1|||<|0.0001|TWO_SIDED|95.0|12.0|24.3|||Cochran-Mantel-Haenszel|||||24.3|12.0|<0.0001
91653968|NCT02974153|183201195|SUPERIORITY||Mean Difference (Final Values)|11.7||||0.0001|TWO_SIDED|95.0|5.8|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.8|0.0001
91653969|NCT02974153|183201196|SUPERIORITY||Mean Difference (Final Values)|21.3|||<|0.0001|TWO_SIDED|95.0|15.0|27.6|||Cochran-Mantel-Haenszel|||||27.6|15.0|<0.0001
91653970|NCT02974153|183201196|SUPERIORITY||Mean Difference (Final Values)|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.3|<0.0001
91653971|NCT02974153|183201197|SUPERIORITY||Mean Difference (Final Values)|22.1|||<|0.0001|TWO_SIDED|95.0|14.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|14.9|<0.0001
91653972|NCT02974153|183201197|SUPERIORITY||Mean Difference (Final Values)|18.2|||<|0.0001|TWO_SIDED|95.0|11.1|25.4|||Cochran-Mantel-Haenszel|||||25.4|11.1|<0.0001
91653973|NCT02974153|183201198|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91653974|NCT02974153|183201198|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91653975|NCT02974153|183201199|SUPERIORITY||Mean Difference (Final Values)|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.88|-0.87|||ANCOVA|||||-0.87|-1.88|<0.0001
91653976|NCT02974153|183201199|SUPERIORITY||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.66|-0.65|||ANCOVA|||||-0.65|-1.66|<0.0001
91653977|NCT02974153|183201200|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA|||||-1.84|-3.91|<0.0001
91788845|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-7.0|||||TWO_SIDED|95.0|-22.3|9.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-22.3|
91788846|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|20.0|||||TWO_SIDED|95.0|8.4|31.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.3|8.4|
91653978|NCT02974153|183201200|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.001|TWO_SIDED|95.0|-2.76|-0.7|||ANCOVA|||||-0.70|-2.76|0.0010
91653979|NCT02974153|183201201|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-14.22|-7.77|||Repeated Measures Model|||||-7.77|-14.22|<0.0001
91788847|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-46.0|-15.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.5|-46.0|
91523693|NCT00279201|182923065|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P-value is for Endpoint mean all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.217
91653980|NCT02974153|183201201|SUPERIORITY||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-11.48|-5.05|||Repeated Measures Model|||||-5.05|-11.48|<0.0001
91653981|NCT01364870|183201235|SUPERIORITY|||||||0.016||||||The p value was adjusted using Bonferroni's method to account for the multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.016
91710263|NCT04607135|183313056|OTHER|||||||0.35||||||q-statistic = 2.04|Games-Howell post-hoc test|||||||0.35
91710264|NCT04607135|183313057|OTHER|||||||0.99|||||||Kruskal-Wallis|||||||0.99
91653982|NCT01364870|183201236|SUPERIORITY|||||||0.008||||||P-value was adjusted using Bonferroni's method to account for multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.008
91653983|NCT04471428|183201239|SUPERIORITY|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens|Hazard Ratio (HR)|0.884||||0.3668|TWO_SIDED|95.0|0.676|1.156|||Log Rank||Hazard ratio was estimated by Cox regression model.|||1.156|0.676|0.3668
91788848|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-10.8|18.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.8|-10.8|
91788849|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|22.0|||||TWO_SIDED|95.0|12.1|32.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.8|12.1|
91788850|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-13.4|7.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.1|-13.4|
91788851|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-3.2|
91788852|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.2|13.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.2|4.2|
91788853|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-15.1|16.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||16.1|-15.1|
91788854|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.7|13.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.9|-4.7|
91788855|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|5.9|20.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|5.9|
91788856|NCT02446743|183457894|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.7|8.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||8.6|-16.7|
91788857|NCT02446743|183457894|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-5.7|11.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-5.7|
91788858|NCT02446743|183457894|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|5.0|||||TWO_SIDED|95.0|-0.7|11.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-0.7|
91710265|NCT04607135|183313058|OTHER|||||||0.74|||||||Kruskal-Wallis|||||||0.74
91653984|NCT04471428|183201239|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.4709|TWO_SIDED|95.0|0.696|1.182|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.182|0.696|0.4709
91653985|NCT04471428|183201240|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0079|TWO_SIDED|95.0|0.585|0.923|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors include histology, and prior NSCLC treatment regimens||0.923|0.585|0.0079
91653986|NCT04471428|183201240|SUPERIORITY||Hazard Ratio (HR)|0.731||||0.0061|TWO_SIDED|95.0|0.583|0.915|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified analysis||0.915|0.583|0.0061
91653987|NCT04471428|183201241|SUPERIORITY||Difference in Response Rates|-1.51||||0.6846|TWO_SIDED|95.0|-8.85|5.84|||Cochran-Mantel-Haenszel||95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||5.84|-8.85|0.6846
91653988|NCT04471428|183201241|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.47|1.63|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||1.63|0.47|
91653989|NCT04471428|183201241|SUPERIORITY||Difference in Response Rates|-1.51||||0.7216|TWO_SIDED|95.0|-8.85|5.84|||Chi-squared, Corrected||95% CIs was computed using the Wald method.|Unstratified Analysis||5.84|-8.85|0.7216
91653990|NCT04471428|183201241|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.47|1.62|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Unstratified Analysis||1.62|0.47|
91653991|NCT04471428|183201243|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.27|TWO_SIDED|95.0|0.59|1.16|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens||1.16|0.59|0.2700
91653992|NCT04471428|183201243|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3031|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.17|0.60|0.3031
91653993|NCT04471428|183201244|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2408|TWO_SIDED|95.0|0.86|1.79|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratification factors include histology, and prior NSCLC treatment regimens||1.79|0.86|0.2408
91653994|NCT04471428|183201244|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.1992|TWO_SIDED|95.0|0.88|1.81|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.81|0.88|0.1992
91653995|NCT04471428|183201245|SUPERIORITY||Difference in Event Free Rate|15.85||||0.0014|TWO_SIDED|95.0|6.12|25.59|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 6 months||25.59|6.12|0.0014
91653996|NCT04471428|183201245|SUPERIORITY||Difference in Event Free Rate|6.32||||0.0719|TWO_SIDED|95.0|-0.56|13.21|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||13.21|-0.56|0.0719
91653997|NCT04471428|183201246|SUPERIORITY||Difference in Event Free Rate|-0.85||||0.8767|TWO_SIDED|95.0|-11.63|9.92|||z-test||The 95% CI for the difference in OS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||9.92|-11.63|0.8767
91653998|NCT03504852|183201253|SUPERIORITY||Risk Difference (RD)|17.72||||0.0003|TWO_SIDED|95.0|7.45|27.98||One-sided p-value|Regression, Logistic|||||27.98|7.45|0.0003
91653999|NCT03504852|183201253|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.44|3.78||One-sided p-value|Regression, Logistic|||||3.78|1.44|0.0003
91654000|NCT03504852|183201254|SUPERIORITY||Risk Difference (RD)|8.28||||0.0498|TWO_SIDED|95.0|-1.65|18.2||One-sided p-value|Regression, Logistic|||||18.20|-1.65|0.0498
91654001|NCT03504852|183201254|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0498|TWO_SIDED|95.0|0.92|2.47||One-sided p-value|Regression, Logistic|||||2.47|0.92|0.0498
91654002|NCT01618305|183201299|SUPERIORITY|P-value was calculated using a Cochran-Mantel-Haenszel test, stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91654003|NCT01618305|183201300|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.557
91654004|NCT01618305|183201301|SUPERIORITY|||||||0.909|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.909
91654005|NCT01618305|183201302|SUPERIORITY|||||||0.938|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by maternal gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.938
91654006|NCT01618305|183201303|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
91654007|NCT01618305|183201304|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
91654008|NCT01618305|183201309|SUPERIORITY|||||||0.623|||||||Fisher Exact|||||||0.623
91654009|NCT01618305|183201310|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||.63
91654010|NCT01618305|183201311|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||.54
91654011|NCT01618305|183201312|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91654012|NCT01618305|183201313|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91654013|NCT01618305|183201314|SUPERIORITY|||||||0.064|||||||Fisher Exact|||The proportion of HIV-infected infants among those who had a determinable HIV-infection status was compared between arms.||||0.064
91654014|NCT00455533|183201331|SUPERIORITY_OR_OTHER|||||||0.8921||95.0|||||Fisher Exact|||||||0.8921
91654015|NCT00455533|183201331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8966|TWO_SIDED|90.0|0.6|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.60|0.8966
91654016|NCT00455533|183201331|SUPERIORITY_OR_OTHER||difference in pCR|-0.6|||||TWO_SIDED|95.0|-7.9|6.7|||||The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.7|-7.9|
91654017|NCT00455533|183201334|SUPERIORITY_OR_OTHER|||||||0.6186||95.0|||||Fisher Exact|||||||0.6186
91654018|NCT00455533|183201334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.5806|TWO_SIDED|90.0|0.56|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.56|0.5806
91654019|NCT00455533|183201334|SUPERIORITY_OR_OTHER||difference|-2.5|||||TWO_SIDED|90.0|-11.0|6.0|||||The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.0|-11|
91654020|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4115||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 (209993\_at)||||0.4115
91523694|NCT00279201|182923066|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.300
91654021|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.1629
91654022|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5074
91654023|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.5530
91654024|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1845||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1845
91654025|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3538||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.3538
91654026|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.9751||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9751
91654027|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.8874||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.8874
91654028|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.6907||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.6907
91654029|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.8052||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.8052
91654030|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5031||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.5031
91654031|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.7588||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.7588
91654032|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1542||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.1542
91788859|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-30.0|||||TWO_SIDED|95.0|-40.4|-19.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-19.0|-40.4|
91788860|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.6|10.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.3|-2.6|
91788861|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|3.9|12.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.5|3.9|
91788862|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-27.0|||||TWO_SIDED|95.0|-41.8|-12.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-12.9|-41.8|
91788863|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-6.0|16.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.2|-6.0|
91710266|NCT03836209|183313084|SUPERIORITY||Proportion Difference|-0.071||||0.366|TWO_SIDED|90.0|-0.205|0.062||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.062|-0.205|0.366
91788864|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|7.0|||||TWO_SIDED|95.0|1.4|15.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|1.4|
91788865|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-45.1|-14.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-14.6|-45.1|
91788866|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|1.9|13.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.5|1.9|
91788867|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.4|15.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.0|4.4|
91788868|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.5|-16.0|
91788869|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
91788870|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-0.33|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-0.33|
91788871|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-20.5|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-20.5|
91788872|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
91788873|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
91654033|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0235||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0235
91788874|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-19.4|13.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||13.0|-19.4|
91788875|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
91613512|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
91613513|NCT00406315|183121309|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
91613514|NCT02202031|183121317|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.6222|TWO_SIDED|95.0|-0.73|1.21|||ANCOVA|change from baseline, adjusted for baseline value||||1.21|-0.73|0.6222
91613515|NCT02202031|183121318|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.7695|TWO_SIDED|95.0|-0.64|0.47|||ANCOVA|change from baseline, adjusted for baseline value||||0.47|-0.64|0.7695
91654034|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3612||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.3612
91710267|NCT03836209|183313085|SUPERIORITY||Proportion Difference|-0.059||||0.446|TWO_SIDED|90.0|-0.191|0.073||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.073|-0.191|0.446
91654035|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1840
91654036|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0942||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0942
91710268|NCT03836209|183313086|SUPERIORITY||Proportion Difference|0.047||||0.539|TWO_SIDED|90.0|-0.084|0.178||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.178|-0.084|0.539
91654037|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5327||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.5327
91654038|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.8847||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8847
91788876|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.2|9.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.4|-1.2|
91788877|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-20.0|||||TWO_SIDED|95.0|-30.0|-11.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.1|-30.0|
91788878|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.6|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-7.6|
91788879|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|32.0|||||TWO_SIDED|95.0|23.2|40.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||40.2|23.2|
91788880|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-13.0|||||TWO_SIDED|95.0|-25.9|-3.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-3.0|-25.9|
91788881|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-17.1|15.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.9|-17.1|
91788882|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|20.5|45.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.3|20.5|
91788883|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-25.0|||||TWO_SIDED|95.0|-40.1|-11.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.2|-40.1|
91788884|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|-3.9|28.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.1|-3.9|
91654039|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.8947||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8947
91710269|NCT03836209|183313087|SUPERIORITY||Proportion Difference|0.131||||0.042|TWO_SIDED|90.0|0.02|0.242||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.242|0.020|0.042
91788885|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|22.0|44.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||44.1|22.0|
91610582|NCT01512368|183114679|SUPERIORITY_OR_OTHER||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.063|<|0.001|TWO_SIDED|95.0|0.034|0.144||All reported p values are based on two-sided tests considering ≤0.05 as significant.|Regression, Linear|Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.|Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.|"FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final - basal levels (delta)."||0.144|0.034|<0.001
91610583|NCT01570491|183114695|SUPERIORITY_OR_OTHER|||||||0.83|||||||Kruskal-Wallis|||"We hypothesized that real-time US guidance would result in a 20% lower number of attempts compared to the control group.~At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group, therefore we planned to recruit 40 patients in total."||||0.83
91610584|NCT01570491|183114696|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91610585|NCT01570491|183114697|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
91610586|NCT01570491|183114698|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
91610587|NCT01720667|183114706|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of 24 hour seizure termination rates using a Fisher's exact test.||||<0.001
91610588|NCT01720667|183114707|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of seizure cessation at 48 hours using Fisher's exact test||||<0.001
91610589|NCT01499576|183114719|SUPERIORITY_OR_OTHER||percent agreement|89.2|||||TWO_SIDED|||||||||||||
91610590|NCT01499576|183114720|SUPERIORITY_OR_OTHER||Kappa index of agreement|0.808|||<|0.01|TWO_SIDED||||||Kappa index of agreement|||||||<0.01
91610591|NCT01499576|183114721|SUPERIORITY_OR_OTHER||persent of adverse event|10.48|||||TWO_SIDED|||||||||||||
91610592|NCT01221233|183114766|SUPERIORITY||Median Difference (Final Values)|17.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.000
91610593|NCT03865407|183114772|SUPERIORITY|||||||0.1839|||||||t-test, 2 sided|||||||0.1839
91610594|NCT03865407|183114773|SUPERIORITY|||||||0.3036|||||||t-test, 2 sided|||||||0.3036
91610595|NCT03865407|183114774|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91610596|NCT03865407|183114775|SUPERIORITY|||||||0.1421|||||||t-test, 2 sided|||||||0.1421
91610597|NCT03865407|183114776|SUPERIORITY|||||||0.0022|||||||t-test, 2 sided|||||||0.0022
91610598|NCT03865407|183114777|SUPERIORITY|||||||0.3032|||||||t-test, 2 sided|||||||0.3032
91610599|NCT01645280|183114784|SUPERIORITY_OR_OTHER|||||||0.184|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.184
91610600|NCT01645280|183114784|SUPERIORITY_OR_OTHER|||||||0.13|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.130
91610601|NCT01645280|183114784|SUPERIORITY_OR_OTHER|||||||0.642|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.642
91610602|NCT01645280|183114784|SUPERIORITY_OR_OTHER|||||||0.832|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.832
91610603|NCT01645280|183114785|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.019
91610604|NCT01645280|183114785|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.025
91610605|NCT01645280|183114785|SUPERIORITY_OR_OTHER|||||||0.248|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.248
91610606|NCT01645280|183114785|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.045
91788886|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.0|-16.0|
91788887|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-6.8|8.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.9|-6.8|
91788888|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|11.0|||||TWO_SIDED|95.0|5.3|16.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.9|5.3|
91788889|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-18.0|14.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.1|-18.0|
91788890|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-9.7|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-9.7|
91788891|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|17.0|||||TWO_SIDED|95.0|8.2|27.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||27.8|8.2|
91788892|NCT02446743|183457895|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.1|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.1|
91523695|NCT00279201|182923067|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.134
91523696|NCT00279201|182923067|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for \<7.0%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.089
91610607|NCT01645280|183114786|SUPERIORITY_OR_OTHER|||||||0.381|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.381
91610608|NCT01645280|183114786|SUPERIORITY_OR_OTHER|||||||0.543|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.543
91610609|NCT01645280|183114786|SUPERIORITY_OR_OTHER|||||||0.629|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.629
91610610|NCT01645280|183114786|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.273
91610611|NCT01645280|183114787|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.060
91610612|NCT01645280|183114787|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.134
91523697|NCT00279201|182923067|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.235
91523698|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91610613|NCT01645280|183114787|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.280
91610614|NCT01645280|183114787|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.345
91610615|NCT00234104|183114791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0074||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0074
91610616|NCT00234104|183114791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0459||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0459
91610617|NCT00234104|183114791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.001||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0010
91610618|NCT02052960|183114797|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.86|TWO_SIDED|95.0|0.736|1.359|||Log Rank|||||1.359|0.736|0.86
91610619|NCT02052960|183114798|SUPERIORITY||Mean Difference (Net)|-1.9||||0.77|TWO_SIDED|95.0|-14.5|10.7|||Chi-squared|||||10.7|-14.5|0.77
91610620|NCT02052960|183114799|SUPERIORITY||Mean Difference (Net)|-1.21||||0.83|TWO_SIDED|95.0|-12.05|9.63|||Chi-squared|||||9.63|-12.05|0.83
91610621|NCT02052960|183114800|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.7|TWO_SIDED|95.0|0.814|1.372|||Log Rank|||||1.372|0.814|0.70
91610622|NCT02052960|183114801|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.96|TWO_SIDED|95.0|0.734|1.396|||Log Rank|||||1.396|0.734|0.96
91610623|NCT03849560|183114809|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H1N1 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.22|||||TWO_SIDED|95.0|0.82|1.82||||||||1.82|0.82|
91610624|NCT03849560|183114809|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H3N2 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.54|||||TWO_SIDED|95.0|1.08|2.3||||||||2.30|1.08|
91788893|NCT02446743|183457895|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|11.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.8|-8.4|
91788894|NCT02446743|183457895|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|-0.47|12.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.6|-0.47|
91788895|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|3.49|||||TWO_SIDED|95.0|2.85|4.29|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.29|2.85|
91788896|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.73|||||TWO_SIDED|95.0|2.02|3.69|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.69|2.02|
91788897|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|4.46|||||TWO_SIDED|95.0|3.38|5.88|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||5.88|3.38|
91788898|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|8.18|||||TWO_SIDED|95.0|6.51|10.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||10|6.51|
91788899|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|9.58|||||TWO_SIDED|95.0|7.17|13.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||13|7.17|
91610625|NCT03849560|183114809|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage)|Odds Ratio, log|1.39|||||TWO_SIDED|95.0|0.9|2.15||||||||2.15|0.90|
91610626|NCT03849560|183114809|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.05|||||TWO_SIDED|95.0|0.68|1.63||||||||1.63|0.68|
91610627|NCT03849560|183114810|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H1N1 if the upper limit of the two-sided 95% Confidence Interval (CI) of the ratio of means of geometric antibody titers for H1N1 was ≤1.5|Mean Difference (Final Values)|0.8933|||||TWO_SIDED|95.0|0.7762|1.03||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H1N1||1.030|0.7762|
91610628|NCT03849560|183114810|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H3N2 if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for H3N2 was ≤1.5|Median Difference (Final Values)|0.8913|||||TWO_SIDED|95.0|0.7516|1.0593||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H3N2||1.0593|0.7516|
91610629|NCT03849560|183114810|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) vaccine for the strain B/Yamagata if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Yamagata antigen was ≤1|Mean Difference (Final Values)|0.8185|||||TWO_SIDED|95.0|0.6918|0.9683||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) for the strain B/Yamagata||0.9683|0.6918|
91610630|NCT03849560|183114810|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Victoria lineage) vaccine for the strain B/Victoria if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Victoria antigen was ≤1|Mean Difference (Final Values)|1.0328||||0.05|TWO_SIDED|95.0|0.857|1.2445|||ANCOVA|||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Victoria lineage) for the strain B/Victoria||1.2445|0.8570|0.05
91610631|NCT03849560|183114811|NON_INFERIORITY|Seroprotection for strain A/H1N1 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.758|||||||Fisher Exact|||||||0.758
91610632|NCT03849560|183114811|NON_INFERIORITY|Seroprotection for strain A/H3N2 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.282|||||||Fisher Exact|||||||0.282
91613516|NCT02202031|183121319|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.6456|TWO_SIDED|95.0|-0.24|0.39|||ANCOVA|change from baseline value, adjusted for baseline value||||0.39|-0.24|0.6456
91788900|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|6.9|||||TWO_SIDED|95.0|4.82|9.87|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||9.87|4.82|
91788901|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|1.98|3.36|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.98|
91788902|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.65|||||TWO_SIDED|95.0|1.89|3.73|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.73|1.89|
91788903|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|2.51|||||TWO_SIDED|95.0|1.67|3.78|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.78|1.67|
91788904|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|1.9|||||TWO_SIDED|95.0|1.52|2.36|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.36|1.52|
91788905|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|1.88|||||TWO_SIDED|95.0|1.37|2.59|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.59|1.37|
91788906|NCT02446743|183457896|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.41|2.58|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.58|1.41|
91523699|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 36.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523700|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 48.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91610633|NCT03849560|183114811|NON_INFERIORITY|Seroprotection for strain B/Yamagata in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage) group||||||0.352|||||||Fisher Exact|||||||0.352
91523701|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 60.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523702|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 72.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91610634|NCT03849560|183114811|NON_INFERIORITY|Seroprotection for strain B/Victoria in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Victoria lineage) group||||||0.815|||||||Fisher Exact|||||||0.815
91523703|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 84.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523704|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 96.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91523705|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 108|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91610635|NCT03849560|183114812|OTHER|||||||0.452|||||||Log Rank|||||||0.452
91610636|NCT03849560|183114812|OTHER|||||||0.639|||||||Log Rank|||||||0.639
91610637|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of mean geometri|4.86|||||TWO_SIDED|95.0|4.22|5.6||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Quadri group||5.60|4.22|
91654040|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4085||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.4085
91654041|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1119||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.1119
91654042|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0250
91788907|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-7.5|1.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||1.8|-7.5|
91788908|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|53.0|||||TWO_SIDED|95.0|42.1|62.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||62.5|42.1|
91788909|NCT02446743|183457898|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|58.0|||||TWO_SIDED|95.0|50.5|64.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||64.7|50.5|
91654043|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3569||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.3569
91788910|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-14.1|2.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.0|-14.1|
91654044|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4103||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.4103
91654045|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1490
91788911|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|28.1|58.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|28.1|
91654046|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.5590
91654047|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4796||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.4796
91654048|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2794||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2794
91523706|NCT00279201|182923068|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Change from baseline at Week 120.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||0.002
91610638|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.32|||||TWO_SIDED|95.0|4.53|6.24||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Quadri group||6.24|4.53|
91610639|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|5.47|||||TWO_SIDED|95.0|4.78|6.25||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Quadri group||6.25|4.78|
91610640|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.77|||||TWO_SIDED|95.0|4.14|5.49||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Quadri group||5.49|4.14|
91610641|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.21|||||TWO_SIDED|95.0|3.59|4.94||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Yamagata lineage) group||4.94|3.59|
91610642|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.22|||||TWO_SIDED|95.0|4.45|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Yamagata lineage) group||6.12|4.45|
91610643|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|4.04|||||TWO_SIDED|95.0|3.48|4.69||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Plus, trivalent (Yamagata lineage) group||4.69|3.48|
91610644|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.6|||||TWO_SIDED|95.0|3.97|5.34||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Victoria lineage) group||5.34|3.97|
91610645|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.17|||||TWO_SIDED|95.0|4.38|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Victoria lineage) group||6.12|4.38|
91610646|NCT03849560|183114814|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.72|||||TWO_SIDED|95.0|4.0|5.56||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Plus, trivalent (Victoria lineage) group||5.56|4.00|
91610647|NCT01254344|183114838|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a 70% rate (i.e., proportion of participants with success of prophylaxis) for both groups and a significance level of 0.025, at least 200 evaluable participants per group were needed to have 90% probability that the lower limit of the 95% (two-sided) confidence interval for the difference in the response rates between the 2 groups was greater than -15 percentage points."|Difference in percentage of prophylaxis|0.1|||||TWO_SIDED|95.0|-5.2|5.5|||Miettinen and Nurminen|||||5.5|-5.2|
91610648|NCT01254344|183114839|SUPERIORITY_OR_OTHER||Difference in percentage of prophylaxis|1.3|||||TWO_SIDED|95.0|-2.2|5.1|||Miettinen and Nurminen|||||5.1|-2.2|
91654049|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1646||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1646
91654050|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0782||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0782
91523707|NCT00279201|182923068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
91610649|NCT00467649|183114840|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Fisher Exact|||||||0.0180
91610650|NCT01633060|183114852|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.67|||<|0.001|ONE_SIDED|95.0|0.53||||Log Rank||||||0.53|<0.001
91610651|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|4.657||||0.005|TWO_SIDED|95.0|1.584|13.686||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||13.686|1.584|0.005
91610652|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|2.478||||0.114|TWO_SIDED|95.0|0.805|7.632||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.632|0.805|0.114
91610653|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|3.499||||0.026|TWO_SIDED|95.0|1.16|10.555||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.555|1.160|0.026
91610654|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|3.943||||0.012|TWO_SIDED|95.0|1.348|11.534||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||11.534|1.348|0.012
91610655|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|1.223||||0.746|TWO_SIDED|95.0|0.361|4.151||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.151|0.361|0.746
91610656|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|5.562||||0.001|TWO_SIDED|95.0|1.932|16.013||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||16.013|1.932|0.001
91610657|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|2.979||||0.05|TWO_SIDED|95.0|0.999|8.882||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.882|0.999|0.050
91610658|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|4.418||||0.006|TWO_SIDED|95.0|1.521|12.834||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.834|1.521|0.006
91610659|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|4.165||||0.009|TWO_SIDED|95.0|1.425|12.178||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.178|1.425|0.009
91610660|NCT03114969|183115009|SUPERIORITY||Odds Ratio (OR)|1.209||||0.761|TWO_SIDED|95.0|0.357|4.095||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.095|0.357|0.761
91610661|NCT03114969|183115010|SUPERIORITY||Odds Ratio (OR)|2.292||||0.1|TWO_SIDED|95.0|0.853|6.163||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.163|0.853|0.100
91613517|NCT02202031|183121320|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.919|TWO_SIDED|95.0|-0.66|0.6|||ANCOVA|change from baseline, adjusted for baseline value||||0.60|-0.66|0.9190
91613518|NCT02202031|183121321|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.5358|TWO_SIDED|95.0|-2.51|4.84|||ANCOVA|change from baseline, adjusted for baseline value.||||4.84|-2.51|0.5358
91523708|NCT00279201|182923069|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.128
91523709|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523710|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523711|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523712|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523713|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523714|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523715|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523716|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523717|NCT00279201|182923069|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Week 120.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||0.002
91523718|NCT00279201|182923069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
91523719|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523720|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523721|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523722|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523723|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91610662|NCT03114969|183115010|SUPERIORITY||Odds Ratio (OR)|2.642||||0.051|TWO_SIDED|95.0|0.994|7.022||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.022|0.994|0.051
91610663|NCT03114969|183115011|SUPERIORITY||Odds Ratio (OR)|3.995|||<|0.001|TWO_SIDED|95.0|1.808|8.829||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.829|1.808|<0.001
91613519|NCT02202031|183121322|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.4663|TWO_SIDED|95.0|-2.9|6.34|||ANCOVA|change from baseline, adjusted for baseline value||||6.34|-2.90|0.4663
91613520|NCT02202031|183121323|SUPERIORITY||Mean Difference (Final Values)|2.17||||0.3134|TWO_SIDED|95.0|-2.05|6.38|||ANCOVA|change from baseline, adjusted for baseline value||||6.38|-2.05|0.3134
91613521|NCT02202031|183121324|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.5146|TWO_SIDED|95.0|-7.05|3.53|||ANCOVA|change from baseline, adjusted for baseline value||||3.53|-7.05|0.5146
91613522|NCT02202031|183121325|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3611|TWO_SIDED|95.0|-0.44|0.16|||ANCOVA|change from baseline, adjusted for baseline value||||0.16|-0.44|0.3611
91613523|NCT02202031|183121326|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6722|TWO_SIDED|95.0|-2.43|1.57|||ANCOVA|change from baseline, adjusted for baseline value||||1.57|-2.43|0.6722
91613524|NCT02202031|183121327|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0786|TWO_SIDED|95.0|-1.4|0.07|||ANCOVA|change from baseline, adjusted for baseline value||||0.07|-1.4|0.0786
91613525|NCT02202031|183121328|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.2284|TWO_SIDED|95.0|-2.87|0.79|||ANCOVA|change from baseline, adjusted for baseline value||||0.79|-2.87|0.2284
91613526|NCT02202031|183121329|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.0335|TWO_SIDED|95.0|-3.28|-0.13|||ANCOVA|change from baseline, adjusted for baseline value||||-0.13|-3.28|0.0335
91613527|NCT02202031|183121330|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.8408|TWO_SIDED|95.0|-0.66|0.81|||ANCOVA|change from baseline, adjusted for baseline value||||0.81|-0.66|0.8408
91613528|NCT02202031|183121331|SUPERIORITY|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|Mean Difference (Final Values)|0.14||||0.5578|TWO_SIDED|95.0|-0.32|0.6|||ANCOVA|||||0.60|-0.32|0.5578
91613529|NCT02202031|183121332|SUPERIORITY|||||||0.5578|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.5578
91613530|NCT02202031|183121333|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.7301|TWO_SIDED|95.0|-0.79|0.31|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||0.31|-0.79|0.7301
91613531|NCT02202031|183121334|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6646|TWO_SIDED|95.0|-0.89|0.04|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic||||0.04|-0.89|0.6646
91613532|NCT02202031|183121335|SUPERIORITY|||||||0.4993|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.4993
91613533|NCT02202031|183121336|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.7506|TWO_SIDED|95.0|-3.05|4.23|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||4.23|-3.05|0.7506
91613534|NCT02202031|183121337|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.6268|TWO_SIDED|95.0|-6.98|3.87|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||3.87|-6.98|0.6268
91613535|NCT00321984|183121346|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91613536|NCT00321984|183121346|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91613537|NCT00321984|183121346|SUPERIORITY_OR_OTHER|||||||0.72941||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.72941
91613538|NCT00321984|183121348|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91613539|NCT00321984|183121348|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91654051|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1407||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.1407
91654052|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2369||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2369
91654053|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.7756||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.7756
91654054|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2623||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2623
91654055|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3147||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.3147
91654056|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2885||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.2885
91654057|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.7187||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.7187
91654058|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.6017||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.6017
91654059|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.4500
91654060|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0952||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0952
91788912|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|32.7|54.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.1|32.7|
91654061|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.7069||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.7069
91654062|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4767||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.4767
91788913|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|4.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.8|-8.0|
91788914|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|60.0|||||TWO_SIDED|95.0|45.0|71.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||71.5|45.0|
91654063|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.6191||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6191
91654064|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.5276
91654065|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.3323
91654066|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1025
91654067|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1715||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1715
91654068|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.1070
91654069|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2751||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2751
91654070|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0276
91654071|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1689||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1689
91654072|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0769||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0769
91654073|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1058
91654074|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.6406||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.6406
91654075|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1733||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.1733
91788915|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|71.0|||||TWO_SIDED|95.0|61.2|78.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||78.5|61.2|
91788916|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-9.1|4.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4|-9.1|
91654076|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2631||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2631
91654077|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.2170
91654078|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0868||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0868
91654079|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1117||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1117
91654080|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4943||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 (208601\_s\_at)||||0.4943
91654081|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.5190
91654082|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.735||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7350
91654083|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.3820
91788917|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|37.0|||||TWO_SIDED|95.0|27.0|48.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||48.1|27.0|
91788918|NCT02446743|183457898|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|33.0|||||TWO_SIDED|95.0|25.2|40.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||40.4|25.2|
91654084|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.9290
91654085|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0699||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.0699
91523724|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523725|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523726|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91654086|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3515||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.3515
91523727|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 120.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91654087|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2128||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2128
91654088|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1275||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.1275
91523728|NCT00279201|182923070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
91523729|NCT00279201|182923071|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value is for Overall hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.370
91523730|NCT00279201|182923071|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-Value for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.006
91523731|NCT00279201|182923071|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.397
91654089|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2158
91523732|NCT00279201|182923071|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.253
91523733|NCT00279201|182923071|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for Severe episodes endpoint.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.893
91523734|NCT00279201|182923071|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.391
91523735|NCT00279201|182923072|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.497
91523736|NCT00279201|182923072|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.071
91523737|NCT00279201|182923072|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.065
91523738|NCT00279201|182923072|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.021
91523739|NCT00279201|182923072|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.200
91788919|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|2.0|||||TWO_SIDED|95.0|-8.7|10.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.2|-8.7|
91654090|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0266
91788920|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|43.0|||||TWO_SIDED|95.0|27.7|58.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.6|27.7|
91788921|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|42.0|||||TWO_SIDED|95.0|31.1|53.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||53.0|31.1|
91788922|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|0.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||0.9|-19.2|
91788923|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|32.0|||||TWO_SIDED|95.0|18.2|47.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|18.2|
91788924|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|24.0|||||TWO_SIDED|95.0|13.2|34.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||34.4|13.2|
91523740|NCT00279201|182923072|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.208
91788925|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.7|3.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.4|-4.7|
91654091|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3636||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.3636
91654092|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.9479||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.9479
91654093|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3753||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.3753
91654094|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5477||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5477
91654095|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.4760
91788926|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|36.0|||||TWO_SIDED|95.0|25.6|45.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||45.7|25.6|
91788927|NCT02446743|183457898|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|54.0|||||TWO_SIDED|95.0|45.2|61.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||61.1|45.2|
91788928|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|5.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-8.4|
91788929|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|29.0|||||TWO_SIDED|95.0|12.1|43.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||43.0|12.1|
91788930|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|46.0|||||TWO_SIDED|95.0|33.6|57.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||57.1|33.6|
91788931|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-8.0|
91788932|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|27.8|54.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.5|27.8|
91788933|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|60.0|||||TWO_SIDED|95.0|47.9|69.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||69.6|47.9|
91788934|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.1|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-1.1|
91788935|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|28.0|||||TWO_SIDED|95.0|19.1|34.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||34.9|19.1|
91654096|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3314
91654097|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.1005||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1005
91610664|NCT03114969|183115011|SUPERIORITY||Odds Ratio (OR)|2.181||||0.069|TWO_SIDED|95.0|0.94|5.059||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.059|0.940|0.069
91610665|NCT03114969|183115011|SUPERIORITY||Odds Ratio (OR)|4.855|||<|0.001|TWO_SIDED|95.0|2.339|10.08||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||10.080|2.339|<0.001
91610666|NCT03114969|183115011|SUPERIORITY||Odds Ratio (OR)|2.71||||0.01|TWO_SIDED|95.0|1.274|5.764||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.764|1.274|0.010
91610667|NCT03114969|183115012|SUPERIORITY||Odds Ratio (OR)|2.503||||0.108|TWO_SIDED|95.0|0.818|7.659||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.659|0.818|0.108
91610668|NCT03114969|183115012|SUPERIORITY||Odds Ratio (OR)|2.409||||0.122|TWO_SIDED|95.0|0.792|7.331||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.331|0.792|0.122
91610669|NCT03114969|183115013|SUPERIORITY||Odds Ratio (OR)|4.887||||0.001|TWO_SIDED|95.0|1.851|12.903||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||12.903|1.851|0.001
91610670|NCT03114969|183115013|SUPERIORITY||Odds Ratio (OR)|5.484|||<|0.001|TWO_SIDED|95.0|2.106|14.284||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||14.284|2.106|<0.001
91610671|NCT03114969|183115014|SUPERIORITY||Odds Ratio (OR)|3.941|||<|0.001|TWO_SIDED|95.0|1.863|8.337||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.337|1.863|<0.001
91610672|NCT03114969|183115014|SUPERIORITY||Odds Ratio (OR)|2.391||||0.03|TWO_SIDED|95.0|1.088|5.256||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.256|1.088|0.030
91610673|NCT03114969|183115014|SUPERIORITY||Odds Ratio (OR)|4.728|||<|0.001|TWO_SIDED|95.0|2.388|9.364||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.364|2.388|<0.001
91610674|NCT03114969|183115014|SUPERIORITY||Odds Ratio (OR)|2.957||||0.002|TWO_SIDED|95.0|1.473|5.936||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.936|1.473|0.002
91610675|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|2.404||||0.045|TWO_SIDED|95.0|1.018|5.676||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||5.676|1.018|0.045
91710270|NCT01768559|183313092|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|Least Square (LS) Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.064|||ANCOVA||Lixisenatide vs Insulin Glulisine QD|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).||0.064|-0.17|
91654098|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1180
91710271|NCT01768559|183313092|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|0.095|0.328|||ANCOVA||Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||0.328|0.095|
91710272|NCT01768559|183313093|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-2.593|-1.396||Threshold for significance at 0.025 level.|ANCOVA|The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.|Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||-1.396|-2.593|< 0.0001
91710273|NCT05446142|183313159|OTHER||Reference/Test Ratio|95.25|||||TWO_SIDED|90.0|90.82|99.9||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.90|90.82|
91710274|NCT05446142|183313159|OTHER||Reference/Test Ratio|96.3|||||TWO_SIDED|90.0|91.71|101.12||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||101.12|91.71|
91710275|NCT05446142|183313159|OTHER||Reference/Test Ratio|96.57|||||TWO_SIDED|90.0|82.91|112.47||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||112.47|82.91|
91788936|NCT02446743|183457898|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|39.0|||||TWO_SIDED|95.0|31.6|46.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.6|31.6|
91788937|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.9|6.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.7|-4.9|
91654099|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1580
91654100|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4385||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.4385
91523741|NCT00279201|182923073|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, TZD use and sulfo use.||||||0.004
91654101|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.7324||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.7324
91710276|NCT05446142|183313159|OTHER||Reference/Test Ratio|88.56|||||TWO_SIDED|90.0|82.59|94.95||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.95|82.59|
91710277|NCT05446142|183313160|OTHER||Reference/Test Ratio|104.31|||||TWO_SIDED|90.0|91.4|119.04||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||119.04|91.40|
91654102|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2657||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.2657
91654103|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.5637
91610676|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|1.823||||0.172|TWO_SIDED|95.0|0.77|4.319||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.319|0.770|0.172
91610677|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|2.989||||0.016|TWO_SIDED|95.0|1.229|7.272||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||7.272|1.229|0.016
91610678|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|1.747||||0.179|TWO_SIDED|95.0|0.775|3.937||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||3.937|0.775|0.179
91610679|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|1.189||||0.69|TWO_SIDED|95.0|0.509|2.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.775|0.509|0.690
91610680|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|3.363||||0.004|TWO_SIDED|95.0|1.48|7.639||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.639|1.480|0.004
91610681|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|2.848||||0.012|TWO_SIDED|95.0|1.264|6.42||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.420|1.264|0.012
91654104|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.4473||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.4473
91610682|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|4.63|||<|0.001|TWO_SIDED|95.0|1.986|10.791||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.791|1.986|<0.001
91610683|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|2.037||||0.081|TWO_SIDED|95.0|0.916|4.528||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||4.528|0.916|0.081
91654105|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3292||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3292
91654106|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.2054||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.2054
91654107|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.5226||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.5226
91654108|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.172||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.1720
91654109|NCT00455533|183201335|SUPERIORITY_OR_OTHER|||||||0.3346||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.3346
91654110|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.5604||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5604
91610684|NCT03114969|183115015|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.438|2.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.283|0.438|1.000
91654111|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2715||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.2715
91654112|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.5268||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5268
91610685|NCT03114969|183115016|SUPERIORITY||Odds Ratio (OR)|1.935||||0.067|TWO_SIDED|95.0|0.955|3.921||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.921|0.955|0.067
91654113|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6058
91654114|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1918||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1918
91654115|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6712||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6712
91654116|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.9195||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9195
91654117|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.7021||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.7021
91654118|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.3910
91788938|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|25.0|||||TWO_SIDED|95.0|9.7|37.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.1|9.7|
91788939|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|37.0|||||TWO_SIDED|95.0|25.1|47.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|25.1|
91788940|NCT02446743|183457898|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-3.9|7.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.6|-3.9|
91610686|NCT03114969|183115016|SUPERIORITY||Odds Ratio (OR)|2.523||||0.007|TWO_SIDED|95.0|1.283|4.961||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.961|1.283|0.007
91610687|NCT03114969|183115017|SUPERIORITY||Odds Ratio (OR)|2.399||||0.008|TWO_SIDED|95.0|1.252|4.596||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.596|1.252|0.008
91610688|NCT03114969|183115017|SUPERIORITY||Odds Ratio (OR)|1.812||||0.082|TWO_SIDED|95.0|0.926|3.544||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||3.544|0.926|0.082
91610689|NCT03114969|183115017|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.135|6.905||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||6.905|2.135|<0.001
91610690|NCT03114969|183115017|SUPERIORITY||Odds Ratio (OR)|3.231|||<|0.001|TWO_SIDED|95.0|1.81|5.766||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.766|1.810|<0.001
91610691|NCT03114969|183115018|SUPERIORITY||Odds Ratio (OR)|1.931||||0.12|TWO_SIDED|95.0|0.842|4.428||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.428|0.842|0.120
91610692|NCT03114969|183115018|SUPERIORITY||Odds Ratio (OR)|1.636||||0.232|TWO_SIDED|95.0|0.73|3.664||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.664|0.730|0.232
91610693|NCT03114969|183115019|SUPERIORITY||Odds Ratio (OR)|4.217|||<|0.001|TWO_SIDED|95.0|2.019|8.807||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.807|2.019|<0.001
91610694|NCT03114969|183115019|SUPERIORITY||Odds Ratio (OR)|5.41|||<|0.001|TWO_SIDED|95.0|2.66|11.005||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||11.005|2.660|<0.001
91610695|NCT03114969|183115020|SUPERIORITY||Odds Ratio (OR)|2.477||||0.007|TWO_SIDED|95.0|1.274|4.815||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.815|1.274|0.007
91610696|NCT03114969|183115020|SUPERIORITY||Odds Ratio (OR)|2.748||||0.006|TWO_SIDED|95.0|1.328|5.683||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.683|1.328|0.006
91788941|NCT02446743|183457898|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|28.0|||||TWO_SIDED|95.0|20.2|36.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||36.6|20.2|
91610697|NCT03114969|183115020|SUPERIORITY||Odds Ratio (OR)|3.896|||<|0.001|TWO_SIDED|95.0|2.133|7.118||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||7.118|2.133|<0.001
91610698|NCT03114969|183115020|SUPERIORITY||Odds Ratio (OR)|4.777|||<|0.001|TWO_SIDED|95.0|2.508|9.1||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.100|2.508|<0.001
91613540|NCT00321984|183121348|SUPERIORITY_OR_OTHER|||||||0.3146||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.31460
91788942|NCT02446743|183457898|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|31.0|51.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||51.9|31.0|
91788943|NCT03086967|183457906|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91788944|NCT03086967|183457907|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.133
91788945|NCT03086967|183457908|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91788946|NCT03086967|183457909|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91788947|NCT03086967|183457910|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
91788948|NCT03086967|183457911|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91788949|NCT03086967|183457912|SUPERIORITY|||||||0.98|||||||Chi-squared|||||||0.98
91788950|NCT03086967|183457913|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
91788951|NCT03086967|183457914|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91523742|NCT00279201|182923074|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Baseline at Week 0.|ANOVA|ANOVA used with treatment, country, TZD use and Sulfo use in the model.||||||0.204
91523743|NCT00279201|182923074|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-Value is for Change from baseline to endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.017
91613541|NCT02214186|183121350|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
91613542|NCT02214186|183121351|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
91613543|NCT02214186|183121352|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures||||||<0.05
91613544|NCT02214186|183121353|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
91613545|NCT02214186|183121354|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|ANOVA for repeated measures.||||||>0.05
91613546|NCT02214186|183121355|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
91613547|NCT02214186|183121356|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91613548|NCT02214186|183121357|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures.||||||<0.05
91613549|NCT02214186|183121358|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91613550|NCT01426386|183121396|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|7.9|||<|0.001|TWO_SIDED|95.0|5.69|10.18||The a priori threshold for statistical significance was 5% (two-sided)|ANCOVA|Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||10.18|5.69|<0.001
91613551|NCT01426386|183121397|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|11.1|||<|0.001|TWO_SIDED|95.0|6.78|15.48||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||15.48|6.78|<0.001
91613552|NCT01426386|183121398|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|0.8|||<|0.001|TWO_SIDED|95.0|0.56|1.11||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||1.11|0.56|<0.001
91613553|NCT01426386|183121400|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|3.2|||<|0.001|TWO_SIDED|95.0|1.71|4.78||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||4.78|1.71|<0.001
91613554|NCT01426386|183121402|OTHER|Treatment groups were compared using the chi-squared test.||||||0.248||||||No adjustment for multiplicity was applied for the secondary endpoints|Chi-squared|||||||0.248
91613555|NCT03694522|183121409|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0727|TWO_SIDED|95.0|0.44|1.04|||Stratified log-rank test|Adjusted for randomization stratification factors of geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||1.04|0.44|0.0727
91613556|NCT03694522|183121410|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0268|TWO_SIDED|95.0|0.35|0.95|||Stratified log-rank test|Adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.95|0.35|0.0268
91788952|NCT03086967|183457915|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
91610699|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|7.347||||0.176|TWO_SIDED|95.0|0.408|132.143||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||132.143|0.408|0.176
91654119|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2909||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2909
91654120|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.3336||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.3336
91654121|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2360
91788953|NCT03086967|183457916|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
91523744|NCT00279201|182923074|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Change Week 24 to Week 120 endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.020
91523745|NCT00279201|182923075|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.036
91610700|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|9.3||||0.128|TWO_SIDED|95.0|0.526|164.465||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||164.465|0.526|0.128
91610701|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|20.454||||0.038|TWO_SIDED|95.0|1.19|351.613||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||351.613|1.190|0.038
91610702|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|18.776||||0.041|TWO_SIDED|95.0|1.131|311.669||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||311.669|1.131|0.041
91610703|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|8.873||||0.141|TWO_SIDED|95.0|0.484|162.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||162.775|0.484|0.141
91654122|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0281||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0281
91654123|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0434||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0434
91788954|NCT00917644|183457979|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|98.79||||||90.0|94.57|103.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||103.20|94.57|
91788955|NCT00917644|183457981|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%). AUCinf method of determination includes AUClast calculated value.|Ratio of adjusted geometric means|98.72||||||90.0|94.41|103.23|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||103.23|94.41|
91791183|NCT03123185|183460134|OTHER|No hypothesis was tested and no acceptance range was specified.|Geometric mean (gMean) ratio (%)|158.61|STANDARD_ERROR_OF_MEAN|22.4|||TWO_SIDED|90.0|133.679|188.195|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||188.195|133.679|
91523746|NCT00279201|182923076|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.708
91654124|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0283||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0283
91654125|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0151||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0151
91788956|NCT00917644|183457982|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|104.66||||||90.0|95.73|114.42|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Observed directly from data.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||114.42|95.73|
91654126|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1999||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1999
91654127|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0146
91654128|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1185||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.1185
91654129|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.8705||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8705
91788957|NCT02108262|183458006|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|1.0|||=|0.1241|TWO_SIDED|95.0|-0.1|2.5|||Newcombe-Wilson score method|||||2.5|-0.1|= 0.1241
91523747|NCT00279201|182923077|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||0.028
91654130|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0284||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.0284
91654131|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0399||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0399
91654132|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0136||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0136
91654133|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0576
91654134|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2245||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.2245
91788958|NCT02108262|183458006|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.4994|TWO_SIDED|95.0|-0.5|1.7|||Newcombe-Wilson score method|||||1.7|-0.5|= 0.4994
91610704|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|10.215||||0.126|TWO_SIDED|95.0|0.519|200.904||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||200.904|0.519|0.126
91613557|NCT03694522|183121411|SUPERIORITY||Difference|13.1||||0.106|TWO_SIDED|95.0|-2.8|29.0|||Cochran-Mantel-Haenszel|P-value was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions||||29.0|-2.8|0.1060
91613558|NCT03694522|183121413|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.94|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.94|0.38|
91613559|NCT00257192|183121427|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.8|STANDARD_ERROR_OF_MEAN|1.26||0.153|TWO_SIDED|95.0|-4.28|0.67||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).||Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (\<) 0.0124) or for futility (2-sided p-value greater than (\>) 0.4772; The final analysis is to employ a 2-sided p-value \<0.0462.||0.67|-4.28|0.1530
91613560|NCT00257192|183121428|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1289|TWO_SIDED|95.0|-0.48|0.06||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Difference from placebo||0.06|-0.48|0.1289
91654135|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1388||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1388
91654136|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0692||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.0692
91654137|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1058
91654138|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2688
91654139|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0192||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.0192
91654140|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0033||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0033
91654141|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2053||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2053
91654142|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0032||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0032
91654143|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6783||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.6783
91654144|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.1630
91654145|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2944||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2944
91654146|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.3727||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.3727
91654147|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.8796||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8796
91654148|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.8344||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8344
91654149|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2700
91654150|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2624||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2624
91654151|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0830
91654152|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0849
91654153|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6578||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6578
91654154|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0396
91654155|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1657||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1657
91654156|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0675||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.0675
91654157|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1071||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1071
91523748|NCT00279201|182923078|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Cochran-Mantel-Haenszel|Stratified by country, TZD use, and sulfo use.||||||0.738
91654158|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0142
91654159|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2465||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2465
91654160|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0031||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0031
91654161|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1231||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1231
91654162|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0849
91654163|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.2740
91654164|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2383||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2383
91654165|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0644||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.0644
91654166|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2866||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2866
91654167|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1259||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1259
91654168|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0718||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0718
91654169|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.3170
91654170|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.7844||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7844
91654171|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.4688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.4688
91654172|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.8553||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.8553
91654173|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6926||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.6926
91654174|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2222||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.2222
91523749|NCT00279201|182923079|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||<0.001
91654175|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.4676||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.4676
91654176|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2036
91654177|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.4197||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.4197
91788959|NCT02108262|183458007|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|-0.2|||=|0.4988|TWO_SIDED|95.0|-1.4|0.7|||Newcombe-Wilson score method|||||0.7|-1.4|= 0.4988
91610705|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|13.717||||0.082|TWO_SIDED|95.0|0.715|263.125||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||263.125|0.715|0.082
91610706|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|28.283||||0.024|TWO_SIDED|95.0|1.561|512.532||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||512.532|1.561|0.024
91610707|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|21.736||||0.038|TWO_SIDED|95.0|1.183|399.541||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||399.541|1.183|0.038
91610708|NCT03114969|183115021|SUPERIORITY||Odds Ratio (OR)|7.603||||0.188|TWO_SIDED|95.0|0.371|155.763||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||155.763|0.371|0.188
91610709|NCT03114969|183115022|SUPERIORITY||Odds Ratio (OR)|7.781||||0.147|TWO_SIDED|95.0|0.488|124.117||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||124.117|0.488|0.147
91610710|NCT03114969|183115022|SUPERIORITY||Odds Ratio (OR)|9.786||||0.12|TWO_SIDED|95.0|0.553|173.301||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||173.301|0.553|0.120
91610711|NCT03114969|183115023|SUPERIORITY||Odds Ratio (OR)|2.089||||0.395|TWO_SIDED|95.0|0.383|11.389||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||11.389|0.383|0.395
91610712|NCT03114969|183115023|SUPERIORITY||Odds Ratio (OR)|3.25||||0.166|TWO_SIDED|95.0|0.612|17.244||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.244|0.612|0.166
91610713|NCT03114969|183115023|SUPERIORITY||Odds Ratio (OR)|3.196||||0.175|TWO_SIDED|95.0|0.596|17.14||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.140|0.596|0.175
91654178|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0776||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.0776
91788960|NCT02108262|183458007|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.6241|TWO_SIDED|95.0|-0.7|1.9|||Newcombe-Wilson score method|||||1.9|-0.7|= 0.6241
91610714|NCT03114969|183115023|SUPERIORITY||Odds Ratio (OR)|5.408||||0.042|TWO_SIDED|95.0|1.059|27.61||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||27.610|1.059|0.042
91788961|NCT02108262|183458008|OTHER||Hazard Ratio (HR)|1.18|||=|0.5733|TWO_SIDED|95.0|0.67|2.05||Stratified log-rank p-value|Log Rank|||||2.05|0.67|= 0.5733
91610715|NCT03114969|183115024|SUPERIORITY||Odds Ratio (OR)|12.145||||0.09|TWO_SIDED|95.0|0.68|216.818||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||216.818|0.680|0.090
91610716|NCT03114969|183115024|SUPERIORITY||Odds Ratio (OR)|9.991||||0.13|TWO_SIDED|95.0|0.508|196.435||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||196.435|0.508|0.130
91610717|NCT03114969|183115025|SUPERIORITY||Odds Ratio (OR)|11.907||||0.079|TWO_SIDED|95.0|0.753|188.208||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||188.208|0.753|0.079
91610718|NCT03114969|183115025|SUPERIORITY||Odds Ratio (OR)|15.06||||0.063|TWO_SIDED|95.0|0.866|262.042||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||262.042|0.866|0.063
91610719|NCT03114969|183115026|SUPERIORITY||Odds Ratio (OR)|2.67||||0.239|TWO_SIDED|95.0|0.521|13.69||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||13.690|0.521|0.239
91610720|NCT03114969|183115026|SUPERIORITY||Odds Ratio (OR)|2.929||||0.2|TWO_SIDED|95.0|0.567|15.125||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.125|0.567|0.200
91610721|NCT03114969|183115026|SUPERIORITY||Odds Ratio (OR)|4.269||||0.078|TWO_SIDED|95.0|0.848|21.489||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||21.489|0.848|0.078
91610722|NCT03114969|183115026|SUPERIORITY||Odds Ratio (OR)|5.132||||0.046|TWO_SIDED|95.0|1.031|25.55||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||25.550|1.031|0.046
91610723|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|3.483||||0.02|TWO_SIDED|95.0|1.218|9.961||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||9.961|1.218|0.020
91654179|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.4076||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.4076
91788962|NCT02108262|183458008|OTHER||Hazard Ratio (HR)|1.02|||=|0.9717|TWO_SIDED|95.0|0.57|1.8||Stratified log-rank p-value|Log Rank|||||1.80|0.57|= 0.9717
91788963|NCT02700334|183458069|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91788964|NCT02700334|183458070|OTHER|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
91788965|NCT02700334|183458071|OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
91788966|NCT02700334|183458072|OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
91788967|NCT02700334|183458073|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91788968|NCT02700334|183458074|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||||||0.331
91788969|NCT02700334|183458075|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91788970|NCT02700334|183458076|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91523750|NCT00279201|182923080|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.043
91788971|NCT02700334|183458077|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
91710278|NCT05446142|183313160|OTHER||Reference/Test Ratio|90.35|||||TWO_SIDED|90.0|79.17|103.12||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||103.12|79.17|
91654180|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0629
91654181|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2547||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2547
91654182|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.7125||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.7125
91654183|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6001||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.6001
91654184|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.5398||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5398
91654185|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3970
91654186|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.5085||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.5085
91654187|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1213
91654188|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0999||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.0999
91654189|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1201||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1201
91654190|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.1172||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1172
91788972|NCT02700334|183458078|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
91788973|NCT02700334|183458079|OTHER|||||||0.721|||||||Wilcoxon (Mann-Whitney)|||||||0.721
91788974|NCT02700334|183458080|OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
91788975|NCT02700334|183458081|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
91788976|NCT02700334|183458082|OTHER|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
91788977|NCT02700334|183458083|OTHER|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91788978|NCT02700334|183458084|OTHER|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
91788979|NCT02700334|183458085|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
91788980|NCT02312882|183458091|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91788981|NCT00247611|183458126|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance were 0.05 alpha two tailed.|HLM|||For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.||||0.12
91788982|NCT00247611|183458126|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||The p-value was not adjusted for multiple comparisons, and thresholds for significance was 0.05 alpha, two tailed.|HLM|||For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.||||0.024
91788983|NCT00247611|183458127|SUPERIORITY_OR_OTHER||||||>|0.5||95.0||||No adjustments were made.|Generalized Linear Model (GLM)|||For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p \> 0.50. The study was underpowered to detect differences in Viral load.||||>0.50
91788984|NCT00247611|183458128|SUPERIORITY_OR_OTHER|||||||0.12||0.0||||The p-value was not adjusted for multiple comparisons and is reported as 0.12 at alpha 0.05 two tailed|HLM|||For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
91788985|NCT00247611|183458128|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed.|HLM|||For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
91788986|NCT00247611|183458129|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.001
91654191|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.6596||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.6596
91610724|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|2.284||||0.143|TWO_SIDED|95.0|0.757|6.895||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.895|0.757|0.143
91654192|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.3289||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3289
91654193|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.3657||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3657
91710279|NCT05446142|183313160|OTHER||Reference/Test Ratio|79.66|||||TWO_SIDED|90.0|58.7|108.08||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||108.08|58.70|
91710280|NCT05446142|183313160|OTHER||Reference/Test Ratio|80.78|||||TWO_SIDED|90.0|64.82|100.68||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.68|64.82|
91710281|NCT05446142|183313161|OTHER||Reference/Test Ratio|95.34|||||TWO_SIDED|90.0|90.37|100.59||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.59|90.37|
91710282|NCT05446142|183313161|OTHER||Reference/Test Ratio|94.67|||||TWO_SIDED|90.0|89.73|99.88||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.88|89.73|
91788987|NCT00247611|183458129|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.01
91788988|NCT00392379|183458136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|STANDARD_DEVIATION|43.0|<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|Regression, Logistic|||Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).||||<0.05
91654194|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0275||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0275
91654195|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.3946||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3946
91654196|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0074
91710283|NCT05446142|183313161|OTHER||Reference/Test Ratio|95.76|||||TWO_SIDED|90.0|84.1|109.04||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||109.04|84.10|
91710284|NCT05446142|183313161|OTHER||Reference/Test Ratio|88.31|||||TWO_SIDED|90.0|82.36|94.7||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.70|82.36|
91610725|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|5.268||||0.006|TWO_SIDED|95.0|1.615|17.187||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.187|1.615|0.006
91788989|NCT02184624|183458139|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788990|NCT02184624|183458139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
91654197|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2341||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2341
91788991|NCT02184624|183458139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
91523751|NCT00279201|182923081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
91788992|NCT02184624|183458139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788993|NCT02184624|183458139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788994|NCT02184624|183458140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788995|NCT02184624|183458140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
91788996|NCT02184624|183458140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788997|NCT02184624|183458140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788998|NCT02184624|183458140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
91788999|NCT02184624|183458141|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||0.480
91789000|NCT02184624|183458141|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||0.044
91789001|NCT02184624|183458141|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.025
91789002|NCT02184624|183458141|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
91789003|NCT02184624|183458141|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.014
91789004|NCT02184624|183458142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
91789005|NCT02184624|183458142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
91789006|NCT02184624|183458142|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.002
91789007|NCT02184624|183458142|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||0.001
91789008|NCT02184624|183458142|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.003
91789009|NCT02184624|183458143|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
91789010|NCT02184624|183458143|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler|Wilcoxon signed rank test|||||||<0.001
91789011|NCT02184624|183458143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
91789012|NCT02184624|183458143|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler|Wilcoxon signed rank test|||||||<0.001
91789013|NCT02184624|183458143|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler|Wilcoxon signed rank test|||||||<0.001
91789014|NCT02184624|183458144|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91654198|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.0933||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.0933
91654199|NCT00455533|183201336|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2016
91654200|NCT00455533|183201337|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.145|||||TWO_SIDED|90.0|-0.27|-0.017|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.017|-0.27|
91654201|NCT00455533|183201337|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.064|||||TWO_SIDED|90.0|-0.064|0.197|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker STatus||0.197|-0.064|
91654202|NCT00455533|183201337|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.056|||||TWO_SIDED|90.0|-0.152|0.046|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.046|-0.152|
91654203|NCT00455533|183201337|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.116|||||TWO_SIDED|90.0|-0.13|0.37|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.37|-0.13|
91610726|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|4.655||||0.009|TWO_SIDED|95.0|1.478|14.666||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||14.666|1.478|0.009
91610727|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|1.274||||0.679|TWO_SIDED|95.0|0.405|4.005||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.005|0.405|0.679
91610728|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|3.804||||0.01|TWO_SIDED|95.0|1.372|10.544||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||10.544|1.372|0.010
91610729|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|2.555||||0.083|TWO_SIDED|95.0|0.886|7.369||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||7.369|0.886|0.083
91610730|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|5.93||||0.002|TWO_SIDED|95.0|1.89|18.611||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||18.611|1.890|0.002
91610731|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|4.929||||0.007|TWO_SIDED|95.0|1.556|15.612||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.612|1.556|0.007
91610732|NCT03114969|183115027|SUPERIORITY||Odds Ratio (OR)|1.208||||0.746|TWO_SIDED|95.0|0.385|3.788||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.788|0.385|0.746
91610733|NCT03114969|183115028|SUPERIORITY||Odds Ratio (OR)|1.502||||0.404|TWO_SIDED|95.0|0.578|3.905||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.905|0.578|0.404
91654204|NCT00455533|183201338|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.114|||||TWO_SIDED|90.0|-0.258|0.22|||||ixabepilone - paclitaxel|Mem+Cyto/Negative Biomarker Status||0.22|-0.258|
91654205|NCT00455533|183201338|SUPERIORITY_OR_OTHER||DIfference (bootstrap method)|0.009|||||TWO_SIDED|90.0|-0.137|0.155|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.155|-0.137|
91654206|NCT00455533|183201338|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.058|||||TWO_SIDED|90.0|-0.167|0.053|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.053|-0.167|
91654207|NCT00455533|183201338|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.049|||||TWO_SIDED|90.0|-0.227|0.309|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.309|-0.227|
91654208|NCT00455533|183201339|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.29|||||TWO_SIDED|90.0|-0.482|-0.094|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.094|-0.482|
91654209|NCT00455533|183201339|SUPERIORITY_OR_OTHER||Difference (boostrap method)|0.106|||||TWO_SIDED|90.0|-0.073|0.291|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.291|-0.073|
91654210|NCT00455533|183201339|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.09|||||TWO_SIDED|90.0|-0.236|0.067|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.067|-0.236|
91523752|NCT00279201|182923082|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||0.032
91789015|NCT02184624|183458144|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91789016|NCT02184624|183458144|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91523753|NCT00279201|182923083|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.037
91523754|NCT00279201|182923083|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.025
91610734|NCT03114969|183115028|SUPERIORITY||Odds Ratio (OR)|1.591||||0.33|TWO_SIDED|95.0|0.625|4.05||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.050|0.625|0.330
91523755|NCT00279201|182923083|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.132
91610735|NCT03114969|183115029|SUPERIORITY||Odds Ratio (OR)|1.738||||0.189|TWO_SIDED|95.0|0.761|3.968||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.968|0.761|0.189
91610736|NCT03114969|183115029|SUPERIORITY||Odds Ratio (OR)|2.079||||0.086|TWO_SIDED|95.0|0.901|4.799||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.799|0.901|0.086
91610737|NCT03114969|183115029|SUPERIORITY||Odds Ratio (OR)|1.95||||0.082|TWO_SIDED|95.0|0.918|4.142||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.142|0.918|0.082
91610738|NCT03114969|183115029|SUPERIORITY||Odds Ratio (OR)|2.415||||0.018|TWO_SIDED|95.0|1.161|5.024||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.024|1.161|0.018
91610739|NCT03114969|183115030|SUPERIORITY||Odds Ratio (OR)|1.51||||0.472|TWO_SIDED|95.0|0.492|4.633||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.633|0.492|0.472
91610740|NCT03114969|183115030|SUPERIORITY||Odds Ratio (OR)|1.402||||0.553|TWO_SIDED|95.0|0.459|4.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.283|0.459|0.553
91610741|NCT03114969|183115031|SUPERIORITY||Odds Ratio (OR)|2.523||||0.052|TWO_SIDED|95.0|0.993|6.407||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.407|0.993|0.052
91654211|NCT00455533|183201339|SUPERIORITY_OR_OTHER||Difference (bootsrap method)|0.117|||||TWO_SIDED|90.0|-0.218|0.469|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.469|-0.218|
91654212|NCT01739790|183201378|OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
91654213|NCT00862979|183201401|SUPERIORITY||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||||-6.1|-16.5|<.0001
91654214|NCT00862979|183201402|OTHER|difference||||||0.203|||||||Fisher Exact|||Month 6 to Month 9||||0.203
91654215|NCT00862979|183201402|OTHER|difference||||||0.002|||||||Fisher Exact|||Month 9 to Month 18||||0.002
91654216|NCT00862979|183201404|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.6|-8.3|||ANCOVA|||Month 12||-8.3|-19.6|<.0001
91710285|NCT00547157|183313173|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.26|0.07|||||difference is PRT - CRT|||0.07|-0.26|
91789017|NCT02184624|183458144|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91789018|NCT02184624|183458144|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91610742|NCT03114969|183115031|SUPERIORITY||Odds Ratio (OR)|2.757||||0.029|TWO_SIDED|95.0|1.107|6.862||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.862|1.107|0.029
91789019|NCT02184624|183458145|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91523756|NCT00279201|182923083|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.849
91523757|NCT00279201|182923084|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Sulfonylurea/TZD|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.006
91523758|NCT00279201|182923084|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.048
91523759|NCT00279201|182923084|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.258
91610743|NCT03114969|183115032|SUPERIORITY||Odds Ratio (OR)|2.434||||0.024|TWO_SIDED|95.0|1.123|5.276||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.276|1.123|0.024
91654217|NCT00862979|183201404|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||Month 18||-6.1|-16.5|<.0001
91654218|NCT00862979|183201406|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91654219|NCT01027143|183201423|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91789020|NCT02184624|183458145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91789021|NCT02184624|183458145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91789022|NCT02184624|183458145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91789023|NCT02184624|183458145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
91789024|NCT02365233|183458173|SUPERIORITY||||||||||||||||||IRB withheld the data due to inadequate supporting documentation|||
91789025|NCT00934843|183458174|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.35|TWO_SIDED|95.0|0.45|1.33|||Multivariate risk computation|||The current study was designed with an anticipated enrollment of 87 patients per treatment arm to achieve a statistical power of 80% (1- β) while controlling type I error at 0.05 (α) using a more conservative estimate of LCOS rate in the Single Dose MP group of 33%, and an incidence of LCOS in the Two Dose MP group of 15%.||1.33|0.45|0.35
91789026|NCT00934843|183458175|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||A repeated measures analysis of variance framework was used for longitudinal analysis of inotrope score. In order to identify potential confounding variables, a variable was considered a relevant covariate and added into the model with a p ≤ 0.15.|ANCOVA|||||||0.43
91789027|NCT00934843|183458177|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|ANCOVA|||||||0.052
91789028|NCT00934843|183458178|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.||||||0.047
91789029|NCT00160667|183458179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||=|0.965|TWO_SIDED|95.0|-12.82|13.41|||ANCOVA||Estimated value is the difference of Least Square Means.|||13.41|-12.82|=0.965
91789030|NCT00160667|183458179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||=|0.825|TWO_SIDED|95.0|-11.69|14.65|||ANCOVA||Estimated value is the difference of Least Square Means.|||14.65|-11.69|=0.825
91789031|NCT01779219|183458193|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Fisher's exact test (two-tailed)|Fisher Exact|||||||1.0
91789032|NCT01779219|183458194|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
91789033|NCT01779219|183458195|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total length of hospital stay||||0.16
91789034|NCT01779219|183458195|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the preoperative hospital stay||||0.73
91789035|NCT01779219|183458195|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the postoperative hospital stay||||1.0
91789036|NCT01779219|183458196|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total OR time||||<0.001
91789037|NCT01779219|183458196|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Time of preoperative preparations||||0.004
91789038|NCT01779219|183458196|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Time of the operation (skin-to-skin)"||||0.024
91789039|NCT00428584|183458197|SUPERIORITY_OR_OTHER|||||||0.524||||||P value refers to mean change to 30 minute post injection|ANOVA|||The primary efficacy endpoint was analyzed by using a two-way ANOVA model on ranked data including treatment group and site as fixed effect.||||0.524
91789040|NCT00428584|183458198|SUPERIORITY_OR_OTHER|||||||0.484|||||||ANOVA|||||||0.484
91789041|NCT00428584|183458199|SUPERIORITY_OR_OTHER|||||||0.838|||||||ANOVA|||||||0.838
91789042|NCT00428584|183458200|SUPERIORITY_OR_OTHER|||||||0.451||||||No pain is defined as a VAS = 0 for all 21 full dose injections.|Cochran-Mantel-Haenszel|||||||0.451
91789043|NCT00428584|183458201|SUPERIORITY_OR_OTHER|||||||0.338|||||||ANOVA|||||||0.338
91610744|NCT03114969|183115032|SUPERIORITY||Odds Ratio (OR)|2.389||||0.035|TWO_SIDED|95.0|1.061|5.376||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.376|1.061|0.035
91610745|NCT03114969|183115032|SUPERIORITY||Odds Ratio (OR)|2.889||||0.003|TWO_SIDED|95.0|1.434|5.819||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.819|1.434|0.003
91610746|NCT03114969|183115032|SUPERIORITY||Odds Ratio (OR)|2.974||||0.003|TWO_SIDED|95.0|1.461|6.055||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.055|1.461|0.003
91610747|NCT01852344|183115086|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
91610748|NCT01852344|183115086|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
91610749|NCT01852344|183115087|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.236
91610750|NCT01852344|183115088|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
91610751|NCT03443024|183115124|SUPERIORITY|||||||0.0165|||||||ANCOVA|||||||0.0165
91654220|NCT01095003|183201438|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0426|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms||0.99|0.71|0.0426
91610752|NCT03443024|183115124|SUPERIORITY|||||||0.0022|TWO_SIDED|95.0|||||ANCOVA|||||||0.0022
91610753|NCT03443024|183115124|SUPERIORITY|||||||0.0005|TWO_SIDED|95.0|||||ANCOVA|||||||0.0005
91610754|NCT03443024|183115125|SUPERIORITY|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
91610755|NCT03443024|183115125|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
91610756|NCT03443024|183115125|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
91610757|NCT03443024|183115126|SUPERIORITY|||||||0.1917|||||||Cochran-Mantel-Haenszel|||||||0.1917
91610758|NCT03443024|183115126|SUPERIORITY|||||||0.0392|||||||Cochran-Mantel-Haenszel|||||||0.0392
91610759|NCT03443024|183115126|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|||||||0.0023
91610760|NCT03443024|183115127|SUPERIORITY|||||||0.2043|||||||Cochran-Mantel-Haenszel|||||||0.2043
91610761|NCT03443024|183115127|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
91610762|NCT03443024|183115127|SUPERIORITY|||||||0.0018|||||||Cochran-Mantel-Haenszel|||||||0.0018
91610763|NCT03443024|183115128|SUPERIORITY|||||||0.0554|||||||Cochran-Mantel-Haenszel|||||||0.0554
91610764|NCT03443024|183115128|SUPERIORITY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||||||0.0037
91610765|NCT03443024|183115128|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
91610766|NCT03443024|183115129|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|||||||0.0800
91610767|NCT03443024|183115129|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|||||||0.0062
91610768|NCT03443024|183115129|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
91610769|NCT03443024|183115130|SUPERIORITY|||||||0.0773|||||||ANCOVA|||||||0.0773
91610770|NCT03443024|183115130|SUPERIORITY|||||||0.0459|||||||ANCOVA|||||||0.0459
91610771|NCT03443024|183115130|SUPERIORITY|||||||0.0062|TWO_SIDED|95.0|||||ANCOVA|||||||0.0062
91610772|NCT03443024|183115131|SUPERIORITY|||||||0.0047|||||||ANCOVA|||||||0.0047
91610773|NCT03443024|183115131|SUPERIORITY|||||||0.0002|TWO_SIDED|95.0|||||ANCOVA|||||||0.0002
91610774|NCT03443024|183115131|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91610775|NCT03443024|183115132|SUPERIORITY|||||||0.6674|||||||Cochran-Mantel-Haenszel|||||||0.6674
91610776|NCT03443024|183115132|SUPERIORITY|||||||0.1166|||||||Cochran-Mantel-Haenszel|||||||0.1166
91610777|NCT03443024|183115132|SUPERIORITY|||||||0.0119|||||||Cochran-Mantel-Haenszel|||||||0.0119
91610778|NCT03443024|183115133|SUPERIORITY|||||||0.2371|||||||Cochran-Mantel-Haenszel|||||||0.2371
91610779|NCT03443024|183115133|SUPERIORITY|||||||0.1067|||||||Cochran-Mantel-Haenszel|||||||0.1067
91610780|NCT03443024|183115133|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
91610781|NCT03443024|183115134|SUPERIORITY|||||||0.4631|||||||ANCOVA|||||||0.4631
91610782|NCT03443024|183115134|SUPERIORITY|||||||0.0368|||||||ANCOVA|||||||0.0368
91610783|NCT03443024|183115134|SUPERIORITY|||||||0.0232|||||||ANCOVA|||||||0.0232
91610784|NCT03443024|183115135|SUPERIORITY|||||||0.4729|||||||ANCOVA|||||||0.4729
91789044|NCT03259620|183458207|SUPERIORITY|||||||0.2587|||||||Cochran-Mantel-Haenszel|||||||0.2587
91789045|NCT03860935|183458259|SUPERIORITY||||||<|0.0001|||||||Finkelstein-Schoenfeld Method|||||||<0.0001
91789046|NCT03860935|183458260|SUPERIORITY||Least Squares Mean Difference|39.64|STANDARD_ERROR_OF_MEAN|9.477|<|0.0001|TWO_SIDED|96.0|20.18|59.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||59.10|20.18|<0.0001
91789047|NCT03860935|183458261|SUPERIORITY||Least Squares Mean Difference|9.94|STANDARD_ERROR_OF_MEAN|2.024|<|0.0001|TWO_SIDED|96.0|5.79|14.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||14.10|5.79|<0.0001
91523760|NCT00279201|182923084|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.848
91523761|NCT00279201|182923085|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.004
91610785|NCT03443024|183115135|SUPERIORITY|||||||0.0282|||||||ANCOVA|||||||0.0282
91610786|NCT03443024|183115135|SUPERIORITY|||||||0.0506|||||||ANCOVA|||||||0.0506
91523762|NCT00279201|182923086|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.553
91610787|NCT05635838|183115152|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.506||0.0215|TWO_SIDED|95.0|-2.21|-0.18|||ANCOVA|||||-0.18|-2.21|0.0215
91789048|NCT03860935|183458262|SUPERIORITY||Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|96.0|5.73|8.46|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||8.46|5.73|<0.0001
91523763|NCT00279201|182923087|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value is for Mean of all post meals blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.010
91789049|NCT03860935|183458263|SUPERIORITY||Relative Risk Reduction (%)|25.0||||0.0569|TWO_SIDED|||||Cochran-Mantel-Haenszel test is stratified by randomization stratification factors of genotype, NT-proBNP level and eGFR level as recorded in IXRS.|Cochran-Mantel-Haenszel|||||||0.0569
91523764|NCT00279201|182923087|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value is for Average of all blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.035
91523765|NCT00279201|182923088|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean of post-meals blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.516
91523766|NCT00279201|182923088|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||P-value is for Average of all blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.425
91523767|NCT00279201|182923089|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
91610788|NCT05635838|183115154|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.485||0.1671|TWO_SIDED|95.0|-1.65|0.29|||ANCOVA|||||0.29|-1.65|0.1671
91610789|NCT05635838|183115155|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.728||0.7982|TWO_SIDED|95.0|-1.27|1.64|||ANCOVA|||||1.64|-1.27|0.7982
91610790|NCT05635838|183115156|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.73||0.2031|TWO_SIDED|95.0|-0.52|2.4|||ANCOVA|||||2.40|-0.52|0.2031
91789050|NCT01437995|183458277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.3|0.69|1.65||||||||1.65|0.69|
91789051|NCT01437995|183458278|SUPERIORITY_OR_OTHER|||||||0.43|||||||Kruskal-Wallis|||||||0.43
91789052|NCT01437995|183458278|SUPERIORITY_OR_OTHER|||||||0.022|||||||Kruskal-Wallis|||||||0.022
91789053|NCT01437995|183458278|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||||||0.002
91789054|NCT01437995|183458279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.41||||||||1.41|0.63|
91789055|NCT01437995|183458279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.8|1.73||||||||1.73|0.80|
91789056|NCT01437995|183458279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.83|1.81||||||||1.81|0.83|
91789057|NCT01437995|183458280|SUPERIORITY_OR_OTHER|||||||0.15|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.15
91610791|NCT05635838|183115158|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.683||0.2387|TWO_SIDED|95.0|-2.2|0.56|||ANCOVA|||||0.56|-2.20|0.2387
91610792|NCT02858193|183115191|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.|Geometric means ratio|111.63||||0.0482|TWO_SIDED|94.12|100.51|123.99||"treatment p-value reported"|ANOVA||Estimated value and limits are expressed in %|||123.99|100.51|0.0482
91610793|NCT02858193|183115193|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies|geometric means ratio|109.41||||0.0002|TWO_SIDED|94.12|104.93|114.07||"treatment p-value is reported"|ANOVA||Estimated value and limits are expressed in%|||114.07|104.93|0.0002
91654221|NCT01095003|183201439|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.7657|TWO_SIDED|95.0|0.83|1.15|||Log Rank|||||1.15|0.83|0.7657
91654222|NCT01095003|183201440|SUPERIORITY|||||||0.103|||||||Cochran-Mantel-Haenszel|||||||0.103
91654223|NCT01095003|183201441|SUPERIORITY|||||||0.0089|||||||Cochran-Mantel-Haenszel|||||||0.0089
91789058|NCT01437995|183458280|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||<0.001
91789059|NCT01437995|183458280|SUPERIORITY_OR_OTHER|||||||0.027|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.027
91789060|NCT01437995|183458280|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.40
91789061|NCT01437995|183458280|SUPERIORITY_OR_OTHER|||||||0.032|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.032
91789062|NCT01437995|183458280|SUPERIORITY_OR_OTHER|||||||0.21|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.21
91789063|NCT01437995|183458281|SUPERIORITY_OR_OTHER|||||||0.14|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.14
91789064|NCT01437995|183458281|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||<0.001
91610794|NCT02858193|183115194|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.||||||0.593|||||||Friedman|||||||0.5930
91610795|NCT02031146|183115198|OTHER|||||||0.29|||||||Two sample test of proportion in Stata|||||||0.29
91610796|NCT02031146|183115199|OTHER|||||||0.69|||||||Log Rank|||||||0.69
91610797|NCT02031146|183115200|OTHER|||||||0.04|||||||Log Rank|||||||0.04
91610798|NCT00112151|183115204|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
91654224|NCT02637557|183201443|SUPERIORITY||LS Mean Difference|-2.952||||0.6065|TWO_SIDED|95.0|-14.222|8.318||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||8.318|-14.222|0.6065
91654225|NCT02637557|183201443|SUPERIORITY||LS Mean Difference|-9.036||||0.116|TWO_SIDED|95.0|-20.318|2.245||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||2.245|-20.318|0.1160
91789065|NCT01437995|183458281|SUPERIORITY_OR_OTHER|||||||0.031|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.031
91789066|NCT04456673|183458282|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Risk Difference (RD)|-0.435||||0.0002|TWO_SIDED|95.0|-0.682|-0.188|||Negative binomial model||Derived using delta method|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.188|-0.682|0.0002
91789067|NCT04456673|183458283|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least Square (LS) Mean Difference|0.082||||0.0001|TWO_SIDED|95.0|0.04|0.124|||MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-bronchodilator FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.124|0.040|0.0001
91610799|NCT00112151|183115204|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance.|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
91610800|NCT00112151|183115205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.||||<0.05
91523768|NCT00279201|182923089|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
91523769|NCT00279201|182923089|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
91610801|NCT00112151|183115205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
91610802|NCT00112151|183115206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.||||<0.05
91710286|NCT00547157|183313174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.0601|TWO_SIDED|95.0|0.98|2.656|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.656|0.980|0.0601
91654226|NCT02637557|183201443|SUPERIORITY||LS Mean Difference|-11.943||||0.04|TWO_SIDED|95.0|-23.334|-0.551||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.551|-23.334|0.0400
91654227|NCT02637557|183201443|SUPERIORITY|||||||0.0225||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0225
91654228|NCT02637557|183201444|SUPERIORITY||LS Mean Difference|-3.711||||0.4795|TWO_SIDED|95.0|-14.028|6.606||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||6.606|-14.028|0.4795
91654229|NCT02637557|183201444|SUPERIORITY||LS Mean Difference|-2.739||||0.602|TWO_SIDED|95.0|-13.066|7.588||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||7.588|-13.066|0.6020
91654230|NCT02637557|183201444|SUPERIORITY||LS Mean Difference|-8.602||||0.1055|TWO_SIDED|95.0|-19.03|1.826||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.826|-19.030|0.1055
91654231|NCT02637557|183201444|SUPERIORITY|||||||0.1387||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1387
91654232|NCT02637557|183201445|SUPERIORITY||LS Mean Difference|-0.058||||0.7488|TWO_SIDED|95.0|-0.415|0.299||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.299|-0.415|0.7488
91654233|NCT02637557|183201445|SUPERIORITY||LS Mean Difference|-0.254||||0.1627|TWO_SIDED|95.0|-0.611|0.103||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.103|-0.611|0.1627
91610803|NCT00112151|183115206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
91654234|NCT02637557|183201445|SUPERIORITY||LS Mean Difference|-0.417||||0.0237|TWO_SIDED|95.0|-0.777|-0.056||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.056|-0.777|0.0237
91610804|NCT00112151|183115207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.||||<0.05
91610805|NCT00112151|183115207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.||||<0.05
91610806|NCT00112151|183115208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
91654235|NCT02637557|183201445|SUPERIORITY|||||||0.013||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0130
91654236|NCT02637557|183201446|SUPERIORITY||LS Mean Difference|-0.052||||0.747|TWO_SIDED|95.0|-0.369|0.265||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.265|-0.369|0.7470
91654237|NCT02637557|183201446|SUPERIORITY||LS Mean Difference|-0.047||||0.7699|TWO_SIDED|95.0|-0.364|0.27||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.270|-0.364|0.7699
91654238|NCT02637557|183201446|SUPERIORITY||LS Mean Difference|-0.257||||0.1157|TWO_SIDED|95.0|-0.577|0.064||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.064|-0.577|0.1157
91654239|NCT02637557|183201446|SUPERIORITY|||||||0.1374||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1374
91654240|NCT02637557|183201447|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7903|TWO_SIDED|95.0|0.47|1.77||Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.77|0.47|0.7903
91654241|NCT02637557|183201447|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3518|TWO_SIDED|95.0|0.7|2.71||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.71|0.70|0.3518
91654242|NCT02637557|183201447|SUPERIORITY||Odds Ratio (OR)|1.64||||0.1544|TWO_SIDED|95.0|0.83|3.26||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.26|0.83|0.1544
91610807|NCT00112151|183115208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
91654243|NCT02637557|183201448|SUPERIORITY||Odds Ratio (OR)|0.56||||0.1489|TWO_SIDED|95.0|0.25|1.23||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.23|0.25|0.1489
91654244|NCT02637557|183201448|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8891|TWO_SIDED|95.0|0.51|2.19||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.19|0.51|0.8891
91654245|NCT02637557|183201448|SUPERIORITY||Odds Ratio (OR)|1.56||||0.2237|TWO_SIDED|95.0|0.76|3.2||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.20|0.76|0.2237
91654246|NCT02637557|183201449|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6566|TWO_SIDED|95.0|0.48|3.18||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.18|0.48|0.6566
91654247|NCT02637557|183201449|SUPERIORITY||Odds Ratio (OR)|2.01||||0.128|TWO_SIDED|95.0|0.81|4.98||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.98|0.81|0.1280
91654248|NCT02637557|183201449|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1463|TWO_SIDED|95.0|0.79|4.91||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.91|0.79|0.1463
91654249|NCT02637557|183201450|SUPERIORITY||LS Mean Difference|-0.298||||0.5504|TWO_SIDED|95.0|-1.279|0.683||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.683|-1.279|0.5504
91789068|NCT04456673|183458284|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|-3.371||||0.0068|TWO_SIDED|95.0|-5.811|-0.931|||MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates.||-0.931|-5.811|0.0068
91789069|NCT04456673|183458285|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Odds Ratio (OR)|1.164||||0.3329|TWO_SIDED|95.0|0.856|1.581|||Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates.||1.581|0.856|0.3329
91654250|NCT02637557|183201450|SUPERIORITY||LS Mean Difference|0.252||||0.6177|TWO_SIDED|95.0|-0.741|1.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.244|-0.741|0.6177
91654251|NCT02637557|183201450|SUPERIORITY||LS Mean Difference|0.513||||0.3138|TWO_SIDED|95.0|-0.488|1.513||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.513|-0.488|0.3138
91654252|NCT02637557|183201451|SUPERIORITY||LS Mean Difference|0.019||||0.9675|TWO_SIDED|95.0|-0.897|0.935||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.935|-0.897|0.9675
91654253|NCT02637557|183201451|SUPERIORITY||LS Mean Difference|0.419||||0.3741|TWO_SIDED|95.0|-0.507|1.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.345|-0.507|0.3741
91654254|NCT02637557|183201451|SUPERIORITY||LS Mean Difference|0.461||||0.3275|TWO_SIDED|95.0|-0.464|1.385||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.385|-0.464|0.3275
91654255|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.023||||0.856|TWO_SIDED|95.0|-0.226|0.272||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.272|-0.226|0.8560
91654256|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.124||||0.3301|TWO_SIDED|95.0|-0.126|0.373||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.373|-0.126|0.3301
91654257|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.019||||0.8845|TWO_SIDED|95.0|-0.27|0.233||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.233|-0.270|0.8845
91654258|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.02||||0.8879|TWO_SIDED|95.0|-0.262|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.303|-0.262|0.8879
91654259|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.017||||0.9072|TWO_SIDED|95.0|-0.266|0.299||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.299|-0.266|0.9072
91654260|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.108||||0.4573|TWO_SIDED|95.0|-0.393|0.177||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.177|-0.393|0.4573
91654261|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.049||||0.7476|TWO_SIDED|95.0|-0.35|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.251|-0.350|0.7476
91610808|NCT00112151|183115209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
91610809|NCT00112151|183115209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
91610810|NCT02531035|183115227|SUPERIORITY||Percentage difference|13.4|||<|0.001|TWO_SIDED|95.0|8.97|17.81||P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(\<25 kg/m\^2,\>=25 kg/m\^2),Week -2 A1C(\<=9.0%, \>9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).|Cochran-Mantel-Haenszel|||||17.81|8.97|< 0.001
91610811|NCT02531035|183115228|SUPERIORITY||Least Squares Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.54|-0.38|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.38|-0.54|< 0.001
91610812|NCT02531035|183115229|SUPERIORITY||Least squares mean difference|-2.98|||<|0.001|TWO_SIDED|95.0|-3.31|-2.66|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9%, \>9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.||-2.66|-3.31|< 0.001
91654262|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.062||||0.6873|TWO_SIDED|95.0|-0.362|0.239||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.239|-0.362|0.6873
91654263|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.258||||0.0952|TWO_SIDED|95.0|-0.562|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.045|-0.562|0.0952
91654264|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.018||||0.9111|TWO_SIDED|95.0|-0.326|0.291||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.291|-0.326|0.9111
91789070|NCT04456673|183458286|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|0.062||||0.0182|TWO_SIDED|95.0|0.011|0.113|||MMRM model|||Derived from MMRM model with the change from baseline in pre-bronchodilator FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.113|0.011|0.0182
91789071|NCT05508074|183458351|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.45||0.923|TWO_SIDED|95.0|-7.27|6.6|||ANCOVA|adjusted on baseline ALSFRS-R and treatment.||primary analysis results based on estimand 1 (see attached SAP)||6.60|-7.27|0.923
91789072|NCT05508074|183458351|OTHER|FAS post hoc|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.3||0.65|TWO_SIDED|95.0|-5.1|8.2||post hoc analysis on the FAS population, adjusted on baseline NfL on top of previous parameters|ANCOVA|||post hoc analysis adjusted on baseline NfL on top of previous parameters||8.2|-5.1|0.65
91789073|NCT05508074|183458352|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|-0.118||||0.398|TWO_SIDED|95.0|-0.408|0.186|||binomial exact method|||primary analysis results based on estimand 1 (see attached SAP)||0.186|-0.408|0.398
91523770|NCT00279201|182923089|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
91523771|NCT00279201|182923090|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.027
91610813|NCT02531035|183115230|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.002|TWO_SIDED|95.0|-5.7|-1.3|||MMRM|||Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.||-1.3|-5.7|= 0.002
91610814|NCT02531035|183115231|SUPERIORITY||Least squares mean difference|-12.32|||<|0.001|TWO_SIDED|95.0|-18.17|-6.48|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-6.48|-18.17|< 0.001
91610815|NCT01543490|183115243|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05.|Risk Difference (RD)|8.5|STANDARD_ERROR_OF_MEAN|4.03||0.0354|TWO_SIDED|95.0|0.2|16.6||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% confidence interval (CI) was calculated.|||16.6|0.2|0.0354
91789074|NCT05508074|183458353|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|-0.029||||0.835|TWO_SIDED|95.0|-0.326|0.271|||binomial exact method|||calculation based on estimand 1 (see SAP)||0.271|-0.326|0.835
91610816|NCT01543490|183115244|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05, and missing data imputed using the LOCF approach.|Risk Difference (RD)|7.1|STANDARD_ERROR_OF_MEAN|4.07||0.1036|TWO_SIDED|95.0|-1.3|15.0||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% CI was calculated.|||15.0|-1.3|0.1036
91610817|NCT02340104|183115251|EQUIVALENCE|Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.|Ratio of Geometric LS Means|0.789|||||TWO_SIDED|90.0|0.769|0.81|||||Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.|||0.810|0.769|
91610818|NCT01330381|183115262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9002|||||||Cochran-Mantel-Haenszel|||||||0.9002
91610819|NCT01330381|183115263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||Cochran-Mantel-Haenszel|||||||0.3520
91610820|NCT01330381|183115264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5228|||||||Cochran-Mantel-Haenszel|||||||0.5228
91610821|NCT01330381|183115273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377|||||||Chi-squared|||||||0.377
91610822|NCT01330381|183115276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1599|||||||Van Elteren test|||||||0.1599
91610823|NCT01330381|183115277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren test|||||||0.0003
91610824|NCT01330381|183115278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4647|||||||Van Elteren test|||||||0.4647
91610825|NCT01330381|183115279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren test|||||||<0.0001
91610826|NCT01330381|183115280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3044|||||||Van Elteren test|||||||0.3044
91610827|NCT01335971|183115289|SUPERIORITY_OR_OTHER|||||||0.45|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages||||0.45
91610828|NCT01335971|183115289|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages||||0.40
91610829|NCT01335971|183115289|SUPERIORITY_OR_OTHER|||||||0.75|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages||||0.75
91610830|NCT01335971|183115289|SUPERIORITY_OR_OTHER|||||||0.49|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages||||0.49
91610831|NCT01335971|183115289|SUPERIORITY_OR_OTHER|||||||0.88|||||||Kruskal-Wallis|||Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages||||0.88
91610832|NCT01335971|183115289|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages||||0.71
91610833|NCT01335971|183115290|SUPERIORITY_OR_OTHER|||||||0.68|||||||Kruskal-Wallis|||Applies to gene expression of Nrf2 in bronchial epithelial cells||||0.68
91610834|NCT01335971|183115291|SUPERIORITY_OR_OTHER|||||||0.69|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells||||0.69
91610835|NCT01335971|183115291|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells||||<0.01
91610836|NCT01335971|183115292|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells||||0.53
91610837|NCT01335971|183115293|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.||||<0.01
91610838|NCT01335971|183115294|SUPERIORITY_OR_OTHER|||||||0.06|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.||||0.06
91610839|NCT01335971|183115295|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
91610840|NCT01335971|183115296|SUPERIORITY_OR_OTHER|||||||0.41|||||||Kruskal-Wallis|||Applies to C-reactive protein concentration||||0.41
91610841|NCT01335971|183115296|SUPERIORITY_OR_OTHER|||||||0.07|||||||Kruskal-Wallis|||Applies to Interleukin-6 concentration||||0.07
91610842|NCT01335971|183115296|SUPERIORITY_OR_OTHER|||||||0.65|||||||Kruskal-Wallis|||Applies to Interleukin-8 concentration||||0.65
91610843|NCT01335971|183115297|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to interleukin-8 results||||0.71
91610844|NCT01335971|183115297|SUPERIORITY_OR_OTHER|||||||0.33|||||||Kruskal-Wallis|||Applies to secretory leukoprotease inhibitor results||||0.33
91610845|NCT01335971|183115298|SUPERIORITY_OR_OTHER|||||||0.8|||||||Kruskal-Wallis|||Applies to isoprostane results.||||0.80
91610846|NCT01335971|183115298|SUPERIORITY_OR_OTHER|||||||0.35|||||||Kruskal-Wallis|||Applies to thiobarbituric acid reactive substances results.||||0.35
91610847|NCT01335971|183115298|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to total antioxidants results.||||0.53
91610848|NCT01183858|183115299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.671|TWO_SIDED|95.0|0.83|1.33||Unstratified analysis.|Log Rank|||||1.33|0.83|0.671
91610849|NCT01183858|183115305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.625|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||||1.33|0.84|0.625
91789075|NCT05508074|183458354|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|5.31|STANDARD_ERROR_OF_MEAN|7.47||0.481|TWO_SIDED|95.0|-9.72|20.34|||ANCOVA|||based on estimand 1 (see SAP). change of SVC percentage from baseline to 6 months||20.34|-9.72|0.481
91610850|NCT01088412|183115335|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.77|||||TWO_SIDED|95.0|2.24|5.96||||||Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.||5.96|2.24|
91610851|NCT01088412|183115336|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.71|||||TWO_SIDED|95.0|0.39|1.2||||||Epidemiological comparison between incidence of primary malignancies in study versus general population registry data, stratified by age and gender.||1.20|0.39|
91610852|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.03|||||TWO_SIDED|95.0|2.14|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All DM (T1, T2 and DM Not Otherwise Specified \[NOS\] Combined)"||4.15|2.14|
91610853|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|2.74|||||TWO_SIDED|95.0|1.72|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)"||4.15|1.72|
91610854|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.91|||||TWO_SIDED|95.0|1.8|10.69||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined)"||10.69|1.80|
91610855|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.1|||||TWO_SIDED|95.0|0.84|7.93||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined)"||7.93|0.84|
91610856|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|11.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined)"||11.83|0.00|
91610857|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.36|10.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined)"||10.83|0.36|
91610858|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.55|||||TWO_SIDED|95.0|1.24|11.66||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined)"||11.66|1.24|
91610859|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|24.3||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined)"||24.30|0.00|
91610860|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.92|||||TWO_SIDED|95.0|0.56|1.44||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T1 DM."||1.44|0.56|
91610861|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.76|||||TWO_SIDED|95.0|0.36|1.4||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T1DM."||1.40|0.36|
91610862|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.5|||||TWO_SIDED|95.0|0.31|4.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T1DM."||4.38|0.31|
91654265|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.004||||0.9772|TWO_SIDED|95.0|-0.304|0.313||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.313|-0.304|0.9772
91654266|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.235||||0.139|TWO_SIDED|95.0|-0.546|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.546|0.1390
91654267|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.017||||0.9215|TWO_SIDED|95.0|-0.349|0.316||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.316|-0.349|0.9215
91610863|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.42|||||TWO_SIDED|95.0|0.29|4.14||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T1DM."||4.14|0.29|
91610864|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.23||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T1DM."||7.23|0.00|
91610865|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|3.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T1DM."||3.38|0.00|
91610866|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|2.09|||||TWO_SIDED|95.0|0.43|6.1||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T1DM."||6.10|0.43|
91610867|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|0.0|||||TWO_SIDED|95.0|0.0|14.84||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T1DM."||14.84|0.00|
91610868|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.79|||||TWO_SIDED|95.0|2.24|5.96||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T2 DM."||5.96|2.24|
91523772|NCT00279201|182923090|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||0.021
91523773|NCT00279201|182923090|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||0.799
91610869|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.93|||||TWO_SIDED|95.0|2.03|6.87||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T2DM."||6.87|2.03|
91610870|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|6.46|||||TWO_SIDED|95.0|1.33|18.89||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T2DM."||18.89|1.33|
91610871|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T2DM."||7.52|0.00|
91610872|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|31.16||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T2DM."||31.16|0.00|
91610873|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|7.9|||||TWO_SIDED|95.0|0.96|28.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T2DM."||28.52|0.96|
91610874|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.08|16.7||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T2DM."||16.70|0.08|
91610875|NCT01088412|183115343|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|63.97||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T2DM."||63.97|0.00|
91610876|NCT03494725|183115350|SUPERIORITY|||||||0.757||||||Outcome was subjected to transformation to meet model assumptions. The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Linear mixed model||The sample size was computed for a repeated measurement ANOVA with two groups and seven repeated measurements (power=0.85, α=0.05, f=0.1). The calculation resulted in a group size of 56 participants each, which was rounded up to 60 participants per treatment group to account for attrition.||||0.757
91610877|NCT05593432|183115391|SUPERIORITY||Response Rate Difference|29.4|STANDARD_ERROR_OF_MEAN|11.17||0.0129|TWO_SIDED|95.0|7.55|51.33||stratified by Baseline Investigator's Global Assessment (IGA) score (3 or 4)|Cochran-Mantel-Haenszel||stratified by Baseline IGA score (3 or 4)|||51.33|7.55|0.0129
91654268|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.055||||0.7453|TWO_SIDED|95.0|-0.388|0.278||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.278|-0.388|0.7453
91654269|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.393||||0.022|TWO_SIDED|95.0|-0.729|-0.057||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.057|-0.729|0.0220
91610878|NCT05593432|183115391|SUPERIORITY||Odds Ratio (OR)|4.04|||||TWO_SIDED|95.0|1.32|12.38|||||stratified by Baseline IGA score (3 or 4)|||12.38|1.32|
91610879|NCT05593432|183115392|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|30.6|STANDARD_ERROR_OF_MEAN|11.68||0.0141|TWO_SIDED|95.0|7.71|53.51|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||53.51|7.71|0.0141
91610880|NCT05593432|183115392|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|1.31|13.17|||||stratified by Baseline IGA score (3 or 4)|||13.17|1.31|
91610881|NCT05593432|183115394|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|40.3|STANDARD_ERROR_OF_MEAN|12.09||0.0027|TWO_SIDED|95.0|16.61|64.0|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||64.00|16.61|0.0027
91610882|NCT05593432|183115394|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|6.67|||||TWO_SIDED|95.0|1.85|24.02|||||stratified by Baseline IGA score (3 or 4)|||24.02|1.85|
91610883|NCT05593432|183115396|EQUIVALENCE|A log-rank test stratified by randomization stratification factor, Baseline IGA score (3 or 4), was used for between-treatment group comparisons. The hazard ratio and its 95% confidence interval was estimated based on the stratified Cox regression model. using Efron's method accounting for ties.|Hazard Ratio (HR)|2.85||||0.0008|TWO_SIDED|95.0|1.51|5.381|||Log Rank|stratified by Baseline IGA score (3 or 4) between ruxolitinib 1.5% cream and vehicle cream|Cox regression model stratified by Baseline IGA score (3 or 4) was conducted to compare the difference in hazard rate between ruxolitinib 1.5% cream and vehicle cream|||5.381|1.510|0.0008
91610884|NCT01450137|183115405|SUPERIORITY||Risk Difference (RD)|0.45||||0.0301|TWO_SIDED|95.0|0.11|0.79|||Fisher Exact|||||0.79|0.11|0.0301
91654270|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.053||||0.7561|TWO_SIDED|95.0|-0.282|0.387||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.387|-0.282|0.7561
91789076|NCT05508074|183458364|OTHER||adjusted geometric mean ratio|1.04|STANDARD_ERROR_OF_MEAN|1.08||0.609|TWO_SIDED|95.0|0.89|1.21|||ANCOVA|||based on available data at V4||1.21|0.89|0.609
91610885|NCT01450137|183115406|SUPERIORITY||Risk Difference (RD)|0.65||||0.001|TWO_SIDED|95.0|0.36|0.94|||Fisher Exact|||||0.94|0.36|0.0010
91610886|NCT01450137|183115407|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
91610887|NCT01450137|183115408|SUPERIORITY||Mean Difference (Final Values)|25.0||||0.0005|TWO_SIDED|95.0|11.0|39.0|||z-test||Difference between restricted mean survival time at 12 months|||39|11|0.0005
91610888|NCT00069121|183115420|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0038|TWO_SIDED|95.0|0.69|0.93||This test used a two-sided significance level of 5%.|Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.93|0.69|0.0038
91654271|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.071||||0.6758|TWO_SIDED|95.0|-0.406|0.263||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.263|-0.406|0.6758
91654272|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.348||||0.0434|TWO_SIDED|95.0|-0.686|-0.01||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.010|-0.686|0.0434
91654273|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|0.042||||0.8123|TWO_SIDED|95.0|-0.308|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.392|-0.308|0.8123
91610889|NCT00069121|183115421|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.78||||0.0015|TWO_SIDED|95.0|0.67|0.91|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.91|0.67|0.0015
91610890|NCT00069121|183115423|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.83||||0.0367|TWO_SIDED|95.0|0.7|0.99|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.99|0.70|0.0367
91610891|NCT04800315|183115457|SUPERIORITY||Mean Difference (Final Values)|-21.76||||0.003|TWO_SIDED|95.0|-35.81|-7.7|||ANCOVA|||||-7.70|-35.81|0.003
91610892|NCT04800315|183115457|SUPERIORITY||Mean Difference (Final Values)|-13.38||||0.057|TWO_SIDED|95.0|-27.19|0.43|||ANCOVA|||||0.43|-27.19|0.057
91610893|NCT04800315|183115457|SUPERIORITY||Mean Difference (Final Values)|-16.28||||0.029|TWO_SIDED|95.0|-30.88|-1.68|||ANCOVA|||||-1.68|-30.88|0.029
91610894|NCT04800315|183115458|OTHER|Risk Difference|Risk Difference VS Placebo|24.0||||0.004|TWO_SIDED|95.0|8.8|39.2|||Cochran-Mantel-Haenszel|||||39.2|8.8|0.004
91610895|NCT04800315|183115458|OTHER|Risk Difference|Risk Difference VS Placebo|15.3||||0.061|TWO_SIDED|95.0|0.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|0.8|0.061
91610896|NCT04800315|183115458|OTHER|Risk Difference|Risk Difference VS Placebo|28.9|||<|0.001|TWO_SIDED|95.0|13.6|44.2|||Cochran-Mantel-Haenszel|||||44.2|13.6|<0.001
91654274|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.044||||0.8038|TWO_SIDED|95.0|-0.394|0.306||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.306|-0.394|0.8038
91654275|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.3||||0.0954|TWO_SIDED|95.0|-0.654|0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.053|-0.654|0.0954
91654276|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.078||||0.6649|TWO_SIDED|95.0|-0.43|0.275||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.275|-0.430|0.6649
91523774|NCT00279201|182923090|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.676
91610897|NCT04800315|183115459|OTHER|Risk Difference|Difference VS Placebo|23.7||||0.018|TWO_SIDED|95.0|6.2|41.2|||Cochran-Mantel-Haenszel|||||41.2|6.2|0.018
91610898|NCT04800315|183115459|OTHER|Risk Difference|Difference VS Placebo|21.8||||0.033|TWO_SIDED|95.0|4.3|39.3|||Cochran-Mantel-Haenszel|||||39.3|4.3|0.033
91610899|NCT04800315|183115459|OTHER|Risk Difference|Difference VS Placebo|26.7||||0.006|TWO_SIDED|95.0|9.3|44.0|||Cochran-Mantel-Haenszel|||||44.0|9.3|0.006
91610900|NCT04800315|183115460|OTHER|Risk Difference|Risk Difference|18.1|||||TWO_SIDED|95.0|2.3|33.9|||Cochran-Mantel-Haenszel|||||33.9|2.3|
91610901|NCT04800315|183115460|OTHER|Risk Difference|Risk Difference|10.5|||||TWO_SIDED|95.0|-4.6|25.7|||Cochran-Mantel-Haenszel|||||25.7|-4.6|
91610902|NCT04800315|183115460|SUPERIORITY||Risk Difference|15.9|||||TWO_SIDED|95.0|0.4|31.4|||Cochran-Mantel-Haenszel|||||31.4|0.4|
91610903|NCT04800315|183115461|SUPERIORITY||Mean Difference (Final Values)|-28.16|||||TWO_SIDED|95.0|-41.89|-14.44|||ANCOVA|||||-14.44|-41.89|
91610904|NCT04800315|183115461|SUPERIORITY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-27.26|-1.46|||ANCOVA|||||-1.46|-27.26|
91610905|NCT04800315|183115461|SUPERIORITY||Mean Difference (Final Values)|-19.07|||||TWO_SIDED|95.0|-33.53|-4.62|||ANCOVA|||||-4.62|-33.53|
91654277|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.262||||0.1448|TWO_SIDED|95.0|-0.614|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.091|-0.614|0.1448
91710287|NCT00547157|183313175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.731||||0.0259|TWO_SIDED|95.0|1.068|2.806|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.806|1.068|0.0259
91610906|NCT04800315|183115462|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-22.5|||||TWO_SIDED|95.0|-41.46|-3.54|||ANCOVA|||||-3.54|-41.46|
91610907|NCT04800315|183115462|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-13.17|||||TWO_SIDED|95.0|-30.67|4.33|||ANCOVA|||||4.33|-30.67|
91610908|NCT04800315|183115462|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-16.32|||||TWO_SIDED|95.0|-36.4|3.75|||ANCOVA|||||3.75|-36.40|
91523775|NCT00279201|182923090|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||1.000
91523776|NCT00279201|182923090|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||1.000
91654278|NCT02637557|183201452|SUPERIORITY||LS Mean Difference|-0.403||||0.0264|TWO_SIDED|95.0|-0.759|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.759|0.0264
91654279|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|0.102||||0.4137|TWO_SIDED|95.0|-0.143|0.347||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.347|-0.143|0.4137
91654280|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|0.147||||0.2395|TWO_SIDED|95.0|-0.098|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.392|-0.098|0.2395
91654281|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.036||||0.7729|TWO_SIDED|95.0|-0.284|0.212||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.212|-0.284|0.7729
91654282|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|0.079||||0.5824|TWO_SIDED|95.0|-0.205|0.363||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.363|-0.205|0.5824
91610909|NCT04800315|183115463|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.5||||0.042|TWO_SIDED|95.0|2.7|34.3|||Cochran-Mantel-Haenszel|||||34.3|2.7|0.042
91610910|NCT04800315|183115463|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|19.9||||0.029|TWO_SIDED|95.0|4.1|35.7|||Cochran-Mantel-Haenszel|||||35.7|4.1|0.029
91610911|NCT04800315|183115463|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.0||||0.052|TWO_SIDED|95.0|2.3|33.6|||Cochran-Mantel-Haenszel|||||33.6|2.3|0.052
91654283|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|0.028||||0.8466|TWO_SIDED|95.0|-0.256|0.312||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.312|-0.256|0.8466
91654284|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.118||||0.4192|TWO_SIDED|95.0|-0.405|0.169||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.169|-0.405|0.4192
91654285|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.035||||0.8192|TWO_SIDED|95.0|-0.333|0.264||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.264|-0.333|0.8192
91654286|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.073||||0.632|TWO_SIDED|95.0|-0.372|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.226|-0.372|0.6320
91654287|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.345||||0.0254|TWO_SIDED|95.0|-0.647|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.043|-0.647|0.0254
91610912|NCT04800315|183115465|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-23.12|||||TWO_SIDED|95.0|-41.48|-4.76|||ANCOVA|||||-4.76|-41.48|
91654288|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.047||||0.7689|TWO_SIDED|95.0|-0.36|0.266||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.266|-0.360|0.7689
91654289|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.117||||0.4631|TWO_SIDED|95.0|-0.43|0.196||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.196|-0.430|0.4631
91610913|NCT04800315|183115465|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-8.28|||||TWO_SIDED|95.0|-25.16|8.59|||ANCOVA|||||8.59|-25.16|
91610914|NCT04800315|183115465|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-10.87|||||TWO_SIDED|95.0|-29.39|7.66|||ANCOVA|||||7.66|-29.39|
91610915|NCT03851510|183115502|OTHER|95% confidence of prevalence measure.|prevalence|46.3|||||TWO_SIDED|95.0|32.6|60.4||||||All participants that were consented, eligible, and completed the Vector EFL screening (supine).||60.4|32.6|
91654290|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.298||||0.0651|TWO_SIDED|95.0|-0.615|0.019||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.019|-0.615|0.0651
91654291|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.06||||0.7197|TWO_SIDED|95.0|-0.392|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.271|-0.392|0.7197
91654292|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.097||||0.5649|TWO_SIDED|95.0|-0.428|0.234||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.234|-0.428|0.5649
91654293|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.422||||0.0138|TWO_SIDED|95.0|-0.757|-0.087||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.087|-0.757|0.0138
91654294|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|0.06||||0.7202|TWO_SIDED|95.0|-0.269|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.388|-0.269|0.7202
91654295|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.093||||0.5784|TWO_SIDED|95.0|-0.421|0.236||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.236|-0.421|0.5784
91710288|NCT00547157|183313176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593||||0.1039|TWO_SIDED|95.0|0.909|2.793|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy|||2.793|0.909|0.1039
91610916|NCT01287117|183115538|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.96||||0.001|TWO_SIDED|95.0|-4.71|-1.21||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.21|-4.71|0.0010
91610917|NCT01287117|183115538|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.95||||0.0012|TWO_SIDED|95.0|-4.72|-1.18||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.18|-4.72|0.0012
91789077|NCT02142387|183458371|OTHER|||||||0.34|TWO_SIDED|95.0|||||Chi-squared|||||||0.34
91789078|NCT02142387|183458372|OTHER|||||||0.7|||||||Chi-squared|||||||0.7
91610918|NCT01287117|183115538|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.8|||<|0.0001|TWO_SIDED|95.0|-7.49|-4.1||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.10|-7.49|<0.0001
91610919|NCT01287117|183115539|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.75||||0.0035|TWO_SIDED|95.0|-9.59|-1.92||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.92|-9.59|0.0035
91610920|NCT01287117|183115539|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.54||||0.0008|TWO_SIDED|95.0|-10.33|-2.75||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-2.75|-10.33|0.0008
91610921|NCT01287117|183115539|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.8|||<|0.0001|TWO_SIDED|95.0|-16.44|-9.16||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-9.16|-16.44|<0.0001
91610922|NCT01287117|183115540|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.75||||0.0149|TWO_SIDED|95.0|-4.95|-0.54||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-0.54|-4.95|0.0149
91610923|NCT01287117|183115540|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.44||||0.0017|TWO_SIDED|95.0|-5.57|-1.32||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.32|-5.57|0.0017
91654296|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.376||||0.0266|TWO_SIDED|95.0|-0.708|-0.044||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.044|-0.708|0.0266
91654297|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.049||||0.777|TWO_SIDED|95.0|-0.391|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.293|-0.391|0.7770
91789079|NCT02142387|183458373|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
91789080|NCT01101308|183458374|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|97.51|107.27|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||107.27|97.51|
91523777|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.241
91789081|NCT01101308|183458375|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.19|103.0|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||103.00|97.19|
91789082|NCT01101308|183458376|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.14|102.99|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||102.99|97.14|
91789083|NCT02984943|183458377|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
91610924|NCT01287117|183115540|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.93|||<|0.0001|TWO_SIDED|95.0|-9.1|-4.76||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.76|-9.10|<0.0001
91610925|NCT01287117|183115541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0879|TWO_SIDED|95.0|0.95|2.03||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||2.03|0.95|0.0879
91610926|NCT01287117|183115541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.0301|TWO_SIDED|95.0|1.04|2.14||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||2.14|1.04|0.0301
91610927|NCT01287117|183115541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.34|||<|0.0001|TWO_SIDED|95.0|1.63|3.36||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||3.36|1.63|<0.0001
91610928|NCT01287117|183115542|SUPERIORITY_OR_OTHER|||||||0.0148||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0148
91610929|NCT01287117|183115542|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||<0.0001
91610930|NCT01287117|183115542|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91610931|NCT01287117|183115543|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0118
91789084|NCT02984943|183458378|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
91610932|NCT01287117|183115543|SUPERIORITY_OR_OTHER|||||||0.0226||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||0.0226
91654298|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.114||||0.5121|TWO_SIDED|95.0|-0.456|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.228|-0.456|0.5121
91789085|NCT02984943|183458379|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
91789086|NCT02984943|183458380|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
91789087|NCT02984943|183458381|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
91789088|NCT02984943|183458382|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
91789089|NCT02984943|183458383|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
91789090|NCT02984943|183458384|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
91789091|NCT02984943|183458385|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
91654299|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.366||||0.0384|TWO_SIDED|95.0|-0.711|-0.02||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.020|-0.711|0.0384
91523778|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.305
91523779|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.842||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.842
91523780|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.917
91523781|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.648
91523782|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.613||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.613
91523783|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.813
91523784|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.953
91523785|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.933
91523786|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.348
91523787|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.625
91523788|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.573
91523789|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.711||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.711
91523790|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.372
91523791|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.516
91523792|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.639
91523793|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.131
91523794|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.530
91523795|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.578
91789092|NCT02984943|183458386|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
91523796|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.004
91523797|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.951||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.951
91523798|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.580
91523799|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.071
91523800|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.081
91523801|NCT00279201|182923091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||<0.001
91523802|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.542||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.542
91523803|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.003
91523804|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.105
91523805|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.487
91523806|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.491
91523807|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.127
91523808|NCT00279201|182923091|SUPERIORITY_OR_OTHER|||||||0.861||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.861
91523809|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.745
91523810|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.467
91523811|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
91523812|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
91523813|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
91523814|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
91789093|NCT02984943|183458387|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
91654300|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.093||||0.5876|TWO_SIDED|95.0|-0.431|0.245||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.245|-0.431|0.5876
91654301|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.298||||0.0842|TWO_SIDED|95.0|-0.636|0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.040|-0.636|0.0842
91654302|NCT02637557|183201453|SUPERIORITY||LS Mean Difference|-0.452||||0.0098|TWO_SIDED|95.0|-0.793|-0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.110|-0.793|0.0098
91654303|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|0.054||||0.6663|TWO_SIDED|95.0|-0.193|0.301||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.301|-0.193|0.6663
91654304|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|0.148||||0.24|TWO_SIDED|95.0|-0.1|0.396||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.396|-0.100|0.2400
91654305|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.023||||0.856|TWO_SIDED|95.0|-0.273|0.227||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.227|-0.273|0.8560
91654306|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|0.051||||0.7209|TWO_SIDED|95.0|-0.232|0.335||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.335|-0.232|0.7209
91654307|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.013||||0.9283|TWO_SIDED|95.0|-0.297|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.271|-0.297|0.9283
91789094|NCT02984943|183458388|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
91789095|NCT02984943|183458389|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
91654308|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.162||||0.2659|TWO_SIDED|95.0|-0.449|0.124||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.124|-0.449|0.2659
91654309|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.006||||0.968|TWO_SIDED|95.0|-0.31|0.298||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.298|-0.310|0.9680
91654310|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.125||||0.4213|TWO_SIDED|95.0|-0.429|0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.180|-0.429|0.4213
91654311|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.311||||0.0471|TWO_SIDED|95.0|-0.618|-0.004||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.004|-0.618|0.0471
91654312|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.025||||0.8769|TWO_SIDED|95.0|-0.337|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.288|-0.337|0.8769
91654313|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.059||||0.7109|TWO_SIDED|95.0|-0.372|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.254|-0.372|0.7109
91654314|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.254||||0.1146|TWO_SIDED|95.0|-0.57|0.062||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.062|-0.570|0.1146
91654315|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|0.048||||0.7736|TWO_SIDED|95.0|-0.281|0.378||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.378|-0.281|0.7736
91654316|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.02||||0.9059|TWO_SIDED|95.0|-0.35|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.310|-0.350|0.9059
91654317|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.299||||0.0779|TWO_SIDED|95.0|-0.633|0.034||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.034|-0.633|0.0779
91654318|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|0.086||||0.6068|TWO_SIDED|95.0|-0.241|0.412||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.412|-0.241|0.6068
91789096|NCT02984943|183458390|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
91789097|NCT02984943|183458391|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
91523815|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
91523816|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
91789098|NCT02984943|183458392|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
91789099|NCT02984943|183458393|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
91789100|NCT02984943|183458394|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
91789101|NCT02984943|183458395|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
91789102|NCT02984943|183458396|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
91654319|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.024||||0.8838|TWO_SIDED|95.0|-0.352|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.303|-0.352|0.8838
91654320|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.323||||0.0556|TWO_SIDED|95.0|-0.653|0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.008|-0.653|0.0556
91654321|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.051||||0.7673|TWO_SIDED|95.0|-0.389|0.287||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.287|-0.389|0.7673
91654322|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.05||||0.7709|TWO_SIDED|95.0|-0.389|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.289|-0.389|0.7709
91654323|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.386||||0.0273|TWO_SIDED|95.0|-0.728|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.043|-0.728|0.0273
91710289|NCT00547157|183313177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791||||0.5744|TWO_SIDED|95.0|0.342|1.785|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||1.785|0.342|0.5744
91710290|NCT00547157|183313177|SUPERIORITY_OR_OTHER||Difference in objective response rate|-0.044|||||TWO_SIDED|95.0|-0.187|0.112|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.112|-0.187|
91710291|NCT00547157|183313178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.278||||0.807|TWO_SIDED|95.0|0.438|4.043|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||4.043|0.438|0.8070
91523817|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
91654324|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.044||||0.795|TWO_SIDED|95.0|-0.378|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.289|-0.378|0.7950
91654325|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.236||||0.1656|TWO_SIDED|95.0|-0.57|0.098||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.098|-0.570|0.1656
91710292|NCT00547157|183313178|SUPERIORITY_OR_OTHER||Difference in complete response rate|0.029|||||TWO_SIDED|95.0|-0.103|0.141|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.141|-0.103|
91710293|NCT03883477|183313183|OTHER|The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||||0.013||||||1 week P-value|Wilcoxon (Mann-Whitney)|||||||0.013
91710294|NCT03883477|183313183|OTHER|||||||0.007||||||1 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.007
91710295|NCT03883477|183313183|OTHER|||||||0.804||||||6 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.804
91710296|NCT03883477|183313184|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
91710297|NCT03883477|183313185|OTHER|||||||0.561|||||||Wilcoxon (Mann-Whitney)|||||||0.561
91654326|NCT02637557|183201454|SUPERIORITY||LS Mean Difference|-0.385||||0.0254|TWO_SIDED|95.0|-0.722|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.722|0.0254
91654327|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.093||||0.3788|TWO_SIDED|95.0|-0.114|0.3||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.300|-0.114|0.3788
91654328|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.189||||0.0761|TWO_SIDED|95.0|-0.02|0.397||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.397|-0.020|0.0761
91654329|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.021||||0.8415|TWO_SIDED|95.0|-0.232|0.189||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.189|-0.232|0.8415
91654330|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.052||||0.6719|TWO_SIDED|95.0|-0.19|0.294||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.294|-0.190|0.6719
91654331|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.007||||0.9549|TWO_SIDED|95.0|-0.237|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.237|0.9549
91654332|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.096||||0.4408|TWO_SIDED|95.0|-0.342|0.149||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.149|-0.342|0.4408
91654333|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.004||||0.9736|TWO_SIDED|95.0|-0.262|0.253||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.253|-0.262|0.9736
91654334|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.146||||0.2703|TWO_SIDED|95.0|-0.405|0.114||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.114|-0.405|0.2703
91789103|NCT02984943|183458397|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
91610933|NCT01287117|183115543|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91610934|NCT01287117|183115544|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.34||||0.0124|TWO_SIDED|95.0|-4.17|-0.51||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||-0.51|-4.17|0.0124
91654335|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.351||||0.0087|TWO_SIDED|95.0|-0.612|-0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.089|-0.612|0.0087
91654336|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.026||||0.848|TWO_SIDED|95.0|-0.295|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.243|-0.295|0.8480
91789104|NCT02984943|183458398|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
91654337|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.073||||0.5966|TWO_SIDED|95.0|-0.344|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.344|0.5966
91654338|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.324||||0.0203|TWO_SIDED|95.0|-0.596|-0.051||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.051|-0.596|0.0203
91523818|NCT00279201|182923092|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
91654339|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.025||||0.854|TWO_SIDED|95.0|-0.294|0.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.244|-0.294|0.8540
91710298|NCT03883477|183313186|OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.748
91710299|NCT03883477|183313187|OTHER|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||||||0.184
91710300|NCT03883477|183313188|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
91789105|NCT02984943|183458399|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
91789106|NCT02984943|183458400|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
91789107|NCT02984943|183458401|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789108|NCT02984943|183458402|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789109|NCT02984943|183458403|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789110|NCT02984943|183458404|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789111|NCT02984943|183458405|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789112|NCT02984943|183458406|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789113|NCT02984943|183458407|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789114|NCT02984943|183458409|OTHER||||||||||||||||||Descriptive statistics only were used|||
91610935|NCT01287117|183115544|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.16||||0.0012|TWO_SIDED|95.0|-5.05|-1.27||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.27|-5.05|0.0012
91610936|NCT01287117|183115544|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.73|||<|0.0001|TWO_SIDED|95.0|-7.59|-3.87||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.87|-7.59|<0.0001
91610937|NCT01287117|183115545|SUPERIORITY_OR_OTHER||Least squares mean difference|0.26||||0.7956|TWO_SIDED|95.0|-1.76|2.28||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||2.28|-1.76|0.7956
91610938|NCT01287117|183115545|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.31||||0.2286|TWO_SIDED|95.0|-3.46|0.84||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||0.84|-3.46|0.2286
91610939|NCT01287117|183115545|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.96|-2.2||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-2.20|-5.96|<0.0001
91610940|NCT01287117|183115546|SUPERIORITY_OR_OTHER|||||||0.4867||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4867
91654340|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.022||||0.8757|TWO_SIDED|95.0|-0.293|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.250|-0.293|0.8757
91654341|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.332||||0.0174|TWO_SIDED|95.0|-0.605|-0.059||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.059|-0.605|0.0174
91654342|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.078||||0.5831|TWO_SIDED|95.0|-0.202|0.358||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.358|-0.202|0.5831
91654343|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.078||||0.5859|TWO_SIDED|95.0|-0.36|0.204||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.204|-0.360|0.5859
91654344|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.291||||0.0447|TWO_SIDED|95.0|-0.575|-0.007||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.007|-0.575|0.0447
91710301|NCT03883477|183313189|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
91789115|NCT02984943|183458410|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789116|NCT02984943|183458411|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789117|NCT02984943|183458413|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789118|NCT02984943|183458414|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789119|NCT02984943|183458415|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789120|NCT02984943|183458416|OTHER||||||||||||||||||Descriptive statistics only were used|||
91789121|NCT02296138|183458432|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Ratio of rates vs. Tiotropium 5 μg|0.93||||0.0498|TWO_SIDED|99.0|0.85|1.02|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of moderate to severe COPD exacerbation was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.02|0.85|0.0498
91654345|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.093||||0.5365|TWO_SIDED|95.0|-0.203|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.388|-0.203|0.5365
91789122|NCT02296138|183458432|SUPERIORITY||Ratio of rates|0.89||||0.001|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on SPARK/FLAME- Covariates: Smoking status, baseline inhaled corticosteroid, Global Initiative on Chronic Obstructive Lung Disease stage, region, COPD Assessment Test score (replacing baseline symptom score), exacerbations treated with antibiotics/steroids history in previous year (replacing 1-year history of exacerbations)||0.96|0.84|0.0010
91523819|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.467
91523820|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
91610941|NCT01287117|183115546|SUPERIORITY_OR_OTHER|||||||0.1747||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.1747
91610942|NCT01287117|183115546|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91610943|NCT01287117|183115547|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4580
91610944|NCT01287117|183115547|SUPERIORITY_OR_OTHER|||||||0.2087||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.2087
91610945|NCT01287117|183115547|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
91610946|NCT01274897|183115548|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|71.0|||||TWO_SIDED|95.0|71.0|81.0||The immune response considered sufficient if for serogroup A the lower limit of the two-sided 95% Clopper-Pearson confidence interval (CI) of the percentage of subjects with hSBA seroresponse is ≥50%.|Clopper and Pearson||For serogroup A.|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||81|71|
91610947|NCT01274897|183115548|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|82.0|||||TWO_SIDED|95.0|82.0|90.0||The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup C|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||90|82|
91610948|NCT01274897|183115548|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|23.0|||||TWO_SIDED|95.0|23.0|33.0||The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup W|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||33|23|
91610949|NCT01274897|183115548|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|63.0|||||TWO_SIDED|95.0|63.0|74.0||The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For serogroup Y|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||74|63|
91654346|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.057||||0.7067|TWO_SIDED|95.0|-0.355|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.241|-0.355|0.7067
91710302|NCT02432209|183313192|SUPERIORITY||Risk Ratio (RR)|0.81||||0.404|TWO_SIDED|95.0|0.48|1.34|||Chi-squared|||||1.34|0.48|0.404
91610950|NCT02042131|183115552|SUPERIORITY|||||||0.082|||||||Log Rank|||Omnibus test of all three groups||||.082
91610951|NCT02042131|183115552|SUPERIORITY|||||||0.028|||||||Log Rank|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||.028
91610952|NCT02042131|183115552|SUPERIORITY||Cox Proportional Hazard|0.24||||0.04|TWO_SIDED|95.0|0.06|0.96|||Regression, Cox|||Planned contrast #1: TAU vs. S-CRP/E-CRP||0.96|0.06|.040
91789123|NCT02296138|183458432|SUPERIORITY||Ratio of rates|0.91||||0.008|TWO_SIDED|95.0|0.85|0.98|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on HERMES- Covariates: age, sex, smoking status, baseline Long-acting Beta-agonist/inhaled corticosteroid, region and percent predicted post-bronchodilator Forced Expiratory Volume in One Second||0.98|0.85|0.0080
91654347|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.317||||0.0386|TWO_SIDED|95.0|-0.616|-0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.017|-0.616|0.0386
91654348|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|0.042||||0.7804|TWO_SIDED|95.0|-0.253|0.336||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.336|-0.253|0.7804
91654349|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.125||||0.4064|TWO_SIDED|95.0|-0.422|0.171||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.171|-0.422|0.4064
91654350|NCT02637557|183201455|SUPERIORITY||LS Mean Difference|-0.333||||0.0289|TWO_SIDED|95.0|-0.632|-0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.035|-0.632|0.0289
91654351|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|0.037||||0.7207|TWO_SIDED|95.0|-0.167|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.167|0.7207
91654352|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.071||||0.4946|TWO_SIDED|95.0|-0.275|0.133||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.133|-0.275|0.4946
91654353|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.077||||0.4596|TWO_SIDED|95.0|-0.283|0.129||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.129|-0.283|0.4596
91654354|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|0.067||||0.5987|TWO_SIDED|95.0|-0.182|0.315||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.315|-0.182|0.5987
91710303|NCT00305565|183313199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.803|TWO_SIDED|95.0|-2.34|3.02|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.02|-2.34|0.803
91789124|NCT02296138|183458432|SUPERIORITY||Ratio of rates|0.89||||0.0011|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on TRINITY/TRILOGY- Covariates: Treatment, region, severity of airflow limitation, and smoking status as effects, and exacerbations treated with antibiotics/steroids in previous year.||0.96|0.84|0.0011
91523821|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
91523822|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
91654355|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.122||||0.3348|TWO_SIDED|95.0|-0.372|0.127||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.127|-0.372|0.3348
91654356|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.062||||0.6288|TWO_SIDED|95.0|-0.313|0.19||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.190|-0.313|0.6288
91654357|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.048||||0.7193|TWO_SIDED|95.0|-0.312|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.216|-0.312|0.7193
91654358|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.27||||0.0452|TWO_SIDED|95.0|-0.534|-0.006||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.006|-0.534|0.0452
91654359|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.252||||0.0635|TWO_SIDED|95.0|-0.519|0.014||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.014|-0.519|0.0635
91654360|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.126||||0.38|TWO_SIDED|95.0|-0.409|0.156||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.156|-0.409|0.3800
91654361|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.336||||0.02|TWO_SIDED|95.0|-0.62|-0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.053|-0.620|0.0200
91654362|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.328||||0.0244|TWO_SIDED|95.0|-0.614|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.043|-0.614|0.0244
91610953|NCT02042131|183115553|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Omnibus test comparing all three groups.||||<0.001
91610954|NCT02042131|183115553|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
91610955|NCT02042131|183115554|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
91610956|NCT02042131|183115555|SUPERIORITY|||||||0.04|||||||Chi-squared|||Omnibus test of all groups||||0.040
91654363|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.096||||0.5232|TWO_SIDED|95.0|-0.392|0.2||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.200|-0.392|0.5232
91789125|NCT02296138|183458433|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Hazard Ratio (HR)|0.95||||0.1188|TWO_SIDED|99.0|0.87|1.03|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.03|0.87|0.1188
91610957|NCT02042131|183115555|SUPERIORITY||Odds Ratio (OR)|0.1||||0.045|TWO_SIDED|95.0|0.002|0.9|||Chi-squared|||Planned contrast #2: E-CRP vs. TAU/S-CRP||0.9|0.002|0.045
91610958|NCT00035815|183115559|SUPERIORITY_OR_OTHER|||||||0.529||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis of MMT was calculated as a ratio of change from baseline to last follow-up to time to duration until last follow-up. For the patients that died during the study period, the last follow-up time was considered as the time of death with a zero score for MMT measurement. Analysis was performed using intention to treat approach. Comparison of rate of change in MMT scores between the placebo and IGF-1 group was made using two sample t-test or Wilcoxon rank sum test as appropriate.||||0.529
91789126|NCT02296138|183458434|SUPERIORITY||Ratio of events vs. Tiotropium 5 μg|0.89||||0.1265|TWO_SIDED|95.0|0.76|1.03|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of exacerbations leading to hospitalization was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.03|0.76|0.1265
91789127|NCT02296138|183458435|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2773|TWO_SIDED|95.0|0.82|1.06|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.06|0.82|0.2773
91789128|NCT02296138|183458436|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7357|TWO_SIDED|95.0|0.67|1.75|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.75|0.67|0.7357
91789129|NCT00711516|183458437|SUPERIORITY_OR_OTHER||Median Difference (Net)|-241.8||||0.7382|TWO_SIDED|95.0|-2470.0|2102.3||The hierarchical testing procedure was employed to control the studywise error rate at 0.05.|Wilcoxon (Mann-Whitney)|The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.||Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.||2102.3|-2470.0|0.7382
91789130|NCT00711516|183458438|SUPERIORITY_OR_OTHER||Median Difference (Net)|53.2||||0.1661|TWO_SIDED|95.0|-17.8|136.1|||Wilcoxon (Mann-Whitney)|||The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.||136.1|-17.8|0.1661
91523823|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
91610959|NCT00035815|183115560|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.415|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Patients who elected to proceed to tracheostomy were assessed on the day of their procedure. Subjects who continuously utilized NIPPV for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous NIPPV. Survival between groups was compared using the Cox-proportional Hazards model.||1.4|0.77|0.415
91610960|NCT00035815|183115561|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Wilcoxon (Mann-Whitney)|||The final secondary outcome measure was the rate of change in the ALSFRS-r score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.||||0.321
91610961|NCT02606877|183115577|OTHER||T1/R1 Ratio (%)|88.58|STANDARD_DEVIATION|45.1|||TWO_SIDED|90.0|65.4|119.97|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||119.97|65.40|
91610962|NCT02606877|183115578|OTHER||T1/R1 Ratio (%)|80.63|STANDARD_DEVIATION|74.6|||TWO_SIDED|90.0|51.27|126.79|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||126.79|51.27|
91610963|NCT02606877|183115579|OTHER||T2/R2 Ratio (%)|97.17|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|87.84|107.48|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||107.48|87.84|
91654364|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.282||||0.0623|TWO_SIDED|95.0|-0.579|0.015||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.015|-0.579|0.0623
91710304|NCT00305565|183313199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.813|TWO_SIDED|95.0|-2.39|3.05|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.05|-2.39|0.813
91710305|NCT03124537|183313246|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health||Tested whether weekly steps increased from the baseline week in both conditions (main effect of time).||||< .001
91523824|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.745
91610964|NCT02606877|183115580|OTHER||T2/R2 Ratio (%)|99.49|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|87.94|112.56|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||112.56|87.94|
91610965|NCT02606877|183115581|OTHER||T1/R1 Ratio (%)|89.49|STANDARD_DEVIATION|44.3|||TWO_SIDED|90.0|66.33|120.73|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||120.73|66.33|
91610966|NCT03165981|183115600|SUPERIORITY||Risk Ratio (RR)|0.87||||0.7588|TWO_SIDED|95.0|0.36|2.1|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.10|0.36|0.7588
91610967|NCT03165981|183115601|SUPERIORITY||Risk Ratio (RR)|0.97||||0.9412|TWO_SIDED|95.0|0.39|2.4|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.40|0.39|.9412
91610968|NCT03165981|183115602|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
91610969|NCT03165981|183115603|SUPERIORITY||Risk Ratio (RR)|0.87||||0.8325|TWO_SIDED|95.0|0.24|3.13|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||3.13|0.24|0.8325
91610970|NCT03165981|183115604|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
91610971|NCT03165981|183115605|SUPERIORITY||Risk Ratio (RR)|0.73||||0.6101|TWO_SIDED|95.0|0.21|2.48|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.48|0.21|0.6101
91610972|NCT03165981|183115606|SUPERIORITY|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||||||0.848
91523825|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
91610973|NCT03165981|183115608|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91610974|NCT01438710|183115612|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|95.0|||||t-test, 2 sided|||The mean change (i.e., absolute change) from baseline (Day 7, pre-conversion) on FTM overall score to Day 14 (post-conversion) was evaluated using paired t-test (at 0.05 significance level, two sided). An estimation of mean change from baseline and the corresponding 95% confidence interval (CI) were provided.||||0.0048
91610975|NCT00945750|183115617|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.01||||||90.0|0.94|1.09||||||||1.09|0.94|
91610976|NCT00945750|183115618|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
91610977|NCT00945750|183115619|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11||||||90.0|1.04|1.2||||||||1.20|1.04|
91610978|NCT00945750|183115620|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||||90.0|1.02|1.24||||||||1.24|1.02|
91610979|NCT02767570|183115630|SUPERIORITY||Mean Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|For the primary hypothesis that there would be a greater reduction in pain for the altered compared to the consistent FPA group, an effect size of 0.57 was assumed. To achieve 80% power with an alpha of 0.05, 39 participants per group were needed, so our recruitment goal was 40 subjects per group.||-0.5|-1.9|0.001
91610980|NCT02767570|183115631|SUPERIORITY||Mean Difference (Net)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.13||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-0.13|-0.39|<0.001
91610981|NCT02767570|183115632|SUPERIORITY||Mean Difference (Net)|-3.74||||0.006|TWO_SIDED|95.0|-6.42|-1.05||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-1.05|-6.42|0.006
91610982|NCT02767570|183115633|SUPERIORITY||Mean Difference (Net)|-0.06||||0.93|TWO_SIDED|95.0|-1.42|1.3||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||1.30|-1.42|0.93
91610983|NCT02767570|183115634|SUPERIORITY||Mean Difference (Net)|-0.29||||0.85|TWO_SIDED|95.0|-3.38|2.8||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||2.80|-3.38|0.85
91610984|NCT02767570|183115635|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.89|0.9||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||0.90|-0.89|0.99
91710306|NCT03124537|183313246|SUPERIORITY|||||||0.846||||||Controlling for age, sex, education, and health.|Mixed Models Analysis|||Tested whether weekly step increases from the baseline week differed between the two conditions (time by condition interaction).||||.846
91710307|NCT03124537|183313247|SUPERIORITY|||||||0.571||||||Controlling for age, sex, condition, education, and health.|Mixed Models Analysis|||Tested whether exercise self-efficacy increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.571
91789131|NCT00711516|183458439|SUPERIORITY_OR_OTHER||Median Difference (Net)|78.9||||0.5774|TWO_SIDED|95.0|-157.8|311.3|||Wilcoxon (Mann-Whitney)|||||311.3|-157.8|0.5774
91710308|NCT03124537|183313247|SUPERIORITY|||||||0.361|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise self efficacy increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.361
91710309|NCT03124537|183313248|SUPERIORITY|||||||0.564|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether exercise control increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.564
91710310|NCT03124537|183313248|SUPERIORITY|||||||0.641|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise control belief increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.641
91710311|NCT03124537|183313250|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether daily walking was related to mood within-persons.||||< .001
91523826|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
91523827|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
91610985|NCT01981122|183115643|SUPERIORITY|||||||0.095|||||||Mixed Models Analysis|Repeated Measures||||||.095
91610986|NCT00089843|183115644|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|3.2|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||This p value was for the effect of Actonel (risedronate) on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||4.6|1.8|<0.0001
91610987|NCT00089843|183115644|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-0.6||||0.41|TWO_SIDED|95.0|-2.0|0.8||This p value was for the effect of testosterone on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||0.8|-2.0|0.41
91610988|NCT00089843|183115645|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-41.0||||0.002|TWO_SIDED|95.0||||This p value was for the effect of Actonel (risedronate).|Factorial analysis|||Factorial analysis||||0.002
91610989|NCT00089843|183115645|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-11.0||||0.39||95.0||||This p value was for the effect of testosterone.|Factorial analysis|||Factorial analysis||||0.39
91610990|NCT03216265|183115662|OTHER||Least Square Mean difference|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.78|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2).|||-0.78|-2.10|<0.0001
91610991|NCT01306058|183115696|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
91610992|NCT01306058|183115697|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.0001||||||Cycle 1 day 15 vs. cycle 1 day 1|Wilcoxon signed rank test|||||||<0.0001
91610993|NCT01306058|183115697|NON_INFERIORITY|Cycle 2 day 1 vs. cycle 1 day 1. Paired T-test. Two tailed.|||||<|0.0001|||||||Wilcoxon signed rank test|||||||<0.0001
91610994|NCT01306058|183115697|NON_INFERIORITY|eos (end of study) vs. cycle 1 day 1. Paired T-test. Two tailed.||||||0.0009|||||||Wilcoxon signed rank test|||||||0.0009
91610995|NCT01539837|183115700|SUPERIORITY||||||<|0.01||||||calculated|Pairwise comparisons,post-hoc Bonferoni|||||||<0.01
91610996|NCT00849693|183115701|SUPERIORITY_OR_OTHER|||||||0.193||95.0|||||Mixed Models Analysis|||||||0.193
91610997|NCT03069690|183115769|SUPERIORITY||Mean Difference (Net)|-0.3996|STANDARD_ERROR_OF_MEAN|2.665||0.8|TWO_SIDED|95.0|-5.649|4.85||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.850|-5.649|.80
91610998|NCT03069690|183115769|SUPERIORITY||Mean Difference (Net)|-3.387|STANDARD_ERROR_OF_MEAN|2.755||0.8|TWO_SIDED|95.0|-8.813|2.039||The value was not adjusted for multiple comparisons.|ANCOVA|||||2.039|-8.813|.80
91610999|NCT03069690|183115769|SUPERIORITY||Mean Difference (Net)|-1.1729|STANDARD_ERROR_OF_MEAN|2.72||0.8|TWO_SIDED|95.0|-6.53|4.184||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.184|-6.530|.80
91611000|NCT00641147|183115785|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91611001|NCT00641147|183115785|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
91611002|NCT00641147|183115786|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
91611003|NCT00641147|183115787|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||0.85
91611004|NCT00641147|183115788|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
91611005|NCT00641147|183115789|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91611006|NCT00641147|183115790|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
91710312|NCT03124537|183313250|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether daily walking was related to energy within-persons.||||.003
91710313|NCT03124537|183313250|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether the relationship between daily walking and mood differed between males and females (steps by sex interaction).||||< .001
91710314|NCT03124537|183313250|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether the relationship between daily walking and energy differed between males and females (steps by sex interaction).||||< .001
91710315|NCT03124537|183313251|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported vigorous physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.011
91710316|NCT03124537|183313251|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported vigorous physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.232
91710317|NCT03124537|183313252|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported moderate physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.530
91710318|NCT03124537|183313252|SUPERIORITY|||||||0.831|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported moderate physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.831
91710319|NCT03124537|183313253|SUPERIORITY|||||||0.199|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported light physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.199
91710320|NCT03124537|183313253|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported light physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.203
91710321|NCT02029274|183313277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.551|STANDARD_ERROR_OF_MEAN|11.5519||0.9621|TWO_SIDED|95.0|-22.447|23.549|||Repeated measures analysis|||||23.549|-22.447|0.9621
91523828|NCT00279201|182923093|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
91523829|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.837
91523830|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.205
91611007|NCT00641147|183115791|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91611008|NCT00641147|183115792|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
91611009|NCT00641147|183115793|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
91611010|NCT00641147|183115794|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91611011|NCT00641147|183115795|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91611012|NCT00641147|183115796|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91611013|NCT00641147|183115800|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91611014|NCT01629667|183115806|SUPERIORITY_OR_OTHER||Least square mean difference|-1.77||||0.14|TWO_SIDED|95.0|-4.13|0.59|||ANCOVA|||||0.59|-4.13|0.140
91611015|NCT01629667|183115806|SUPERIORITY_OR_OTHER||Least square mean difference|-1.41||||0.234|TWO_SIDED|95.0|-3.73|0.91|||ANCOVA|||||0.91|-3.73|0.234
91611016|NCT00984659|183115840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.713|TWO_SIDED|95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.713
91611017|NCT00984659|183115844|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening.|ANCOVA|||||||<0.001
91611018|NCT00984659|183115845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening.|ANCOVA|||||||<0.001
91611019|NCT00984659|183115846|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening|ANCOVA|||||||0.008
91611020|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.18|0.31||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 8|ANCOVA|||||0.31|0.18|<0.001
91611021|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.001||95.0|0.06|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 15|ANCOVA|||||0.19|0.06|<0.001
91611022|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.16||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 22|ANCOVA|||||0.16|0.06|<0.001
91611023|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.17||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 29|ANCOVA|||||0.17|0.06|<0.001
91611024|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001||95.0|0.08|0.18||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 36|ANCOVA|||||0.18|0.08|<0.001
91611025|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.18||95.0|-0.03|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 43|ANCOVA|||||0.15|-0.03|0.180
91710322|NCT02029274|183313277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.368|STANDARD_ERROR_OF_MEAN|10.9297||0.1637|TWO_SIDED|95.0|-37.128|6.391|||Repeated measures analysis|||||6.391|-37.128|0.1637
91710323|NCT02029274|183313277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.709|STANDARD_ERROR_OF_MEAN|11.6016||0.2409|TWO_SIDED|95.0|-36.806|9.388|||Repeated measures|||||9.388|-36.806|0.2409
91710324|NCT02756364|183313282|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.537|TWO_SIDED|95.0|0.47|1.26|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original interactive response technology (IRT) stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.26|0.47|0.537
91710325|NCT02756364|183313282|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.849|TWO_SIDED|95.0|0.53|1.45|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.45|0.53|0.849
91710326|NCT02756364|183313283|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.276|TWO_SIDED|95.0|0.36|1.4|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.40|0.36|0.276
91789132|NCT00711516|183458440|SUPERIORITY_OR_OTHER||Median Difference (Net)|90.1||||0.861|TWO_SIDED|95.0|-806.7|707.0|||Wilcoxon (Mann-Whitney)|||||707.0|-806.7|0.8610
91789133|NCT00711516|183458441|SUPERIORITY_OR_OTHER||Median Difference (Net)|252.8||||0.6907|TWO_SIDED|95.0|-1066.5|1523.8|||Wilcoxon (Mann-Whitney)|||||1523.8|-1066.5|0.6907
91789134|NCT00711516|183458442|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2456|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-8.0|0.2456
91789135|NCT00711516|183458443|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7115|TWO_SIDED|95.0|-8.0|9.0|||Wilcoxon (Mann-Whitney)|||||9.0|-8.0|0.7115
91789136|NCT00711516|183458444|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.0||||0.6103|TWO_SIDED|95.0|-13.0|19.0|||Wilcoxon (Mann-Whitney)|||||19.0|-13.0|0.6103
91789137|NCT00711516|183458445|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9619|TWO_SIDED|95.0|-18.0|17.0|||Wilcoxon (Mann-Whitney)|||||17.0|-18.0|0.9619
91654365|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.255||||0.0951|TWO_SIDED|95.0|-0.554|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.045|-0.554|0.0951
91611026|NCT00984659|183115848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.307||95.0|-0.07|0.23||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Visit 3/PD|ANCOVA|||||0.23|-0.07|0.307
91611027|NCT00984659|183115852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.14|0.34||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CGI-C responders and non-responders|ANCOVA|||||0.34|0.14|<0.001
91611028|NCT00984659|183115853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.4||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CRQ-SAS Dyspnea Domain responders and non-responders|ANCOVA|||||0.40|0.21|<0.001
91611029|NCT00984659|183115854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.535||95.0|-0.08|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders|ANCOVA|||||0.15|-0.08|0.535
91611030|NCT00984659|183115854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.08||95.0|-0.02|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders|ANCOVA|||||0.19|-0.02|0.08
91611031|NCT00201201|183115866|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (1,161)=4.44,p=0.035).||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.||||0.035
91611032|NCT00201201|183115867|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0204
91611033|NCT00201201|183115868|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0001
91611034|NCT00201201|183115869|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||0.0001
91611035|NCT00201201|183115870|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||t-test, 2 sided|||||||0.0431
91611036|NCT00201201|183115871|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||t-test, 2 sided|||Analyzed at 0 and 12 weeks.||||<.10
91611037|NCT00909090|183115936|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91611038|NCT00909090|183115937|SUPERIORITY|||||||0.21|||||||Regression, Linear|||Analysis compared mean differences between placebo and intervention at the 12-month time point.||||0.21
91611039|NCT00909090|183115938|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||Analysis compared mean change from baseline to 12-month time points.||||0.01
91611040|NCT00909090|183115939|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||analysis conducted on mean change over one year, between groups||||0.02
91611041|NCT02926573|183115942|SUPERIORITY||Median Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.27|0.94||||||||0.94|-0.27|
91654366|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.06||||0.6985|TWO_SIDED|95.0|-0.363|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.243|-0.363|0.6985
91710327|NCT02756364|183313283|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.47|TWO_SIDED|95.0|0.47|1.68|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.68|0.47|0.470
91523831|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.704
91611042|NCT02926573|183115943|SUPERIORITY||Percent Difference|9.2|||||TWO_SIDED|95.0|-3.0|21.0||||||||21|-3.0|
91611043|NCT02926573|183115945|SUPERIORITY||Percent Difference|-2.0|||||TWO_SIDED|95.0|-15.0|11.0|||||"The estimation parameter is based on those participants who answered they were very satisfied with overall pain control."|||11|-15|
91654367|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.373||||0.0163|TWO_SIDED|95.0|-0.677|-0.069||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.069|-0.677|0.0163
91654368|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.345||||0.0273|TWO_SIDED|95.0|-0.652|-0.039||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.039|-0.652|0.0273
91710328|NCT02756364|183313284|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.495|TWO_SIDED|95.0|0.46|1.25|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.25|0.46|0.495
91789138|NCT00711516|183458446|SUPERIORITY_OR_OTHER||Median Difference (Net)|-335.5||||0.4544|TWO_SIDED|95.0|-1270.7|723.3|||Wilcoxon (Mann-Whitney)|||||723.3|-1270.7|0.4544
91789139|NCT00711516|183458447|SUPERIORITY_OR_OTHER||Median Difference (Net)|6410.3||||0.0193|TWO_SIDED|95.0|1064.7|12087.3|||Wilcoxon (Mann-Whitney)|||||12087.3|1064.7|0.0193
91789140|NCT00711516|183458448|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1704|TWO_SIDED|95.0|-0.1|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.1|0.1704
91789141|NCT00711516|183458449|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.0609|TWO_SIDED|95.0|-0.3|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.3|0.0609
91654369|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.056||||0.7187|TWO_SIDED|95.0|-0.362|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.250|-0.362|0.7187
91710329|NCT02756364|183313284|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.646|TWO_SIDED|95.0|0.49|1.38|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.38|0.49|0.646
91710330|NCT02756364|183313285|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.68|7.29|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||7.29|0.68|
91710331|NCT02756364|183313285|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.34|4.39|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.39|0.34|
91710332|NCT02756364|183313286|SUPERIORITY||Odds Ratio (OR)|2.56|||||TWO_SIDED|95.0|0.94|6.94|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||6.94|0.94|
91710333|NCT02756364|183313286|SUPERIORITY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|0.69|4.44|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.44|0.69|
91523832|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.610
91654370|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.29||||0.064|TWO_SIDED|95.0|-0.596|0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.017|-0.596|0.0640
91654371|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.484||||0.0023|TWO_SIDED|95.0|-0.793|-0.175||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.175|-0.793|0.0023
91654372|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.079||||0.6033|TWO_SIDED|95.0|-0.378|0.22||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.220|-0.378|0.6033
91710334|NCT02223364|183313288|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
91710335|NCT02223364|183313288|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91710336|NCT02223364|183313288|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
91710337|NCT02223364|183313289|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91710338|NCT02223364|183313289|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91710339|NCT02223364|183313289|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91710340|NCT02223364|183313290|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91710341|NCT02223364|183313290|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91710342|NCT02223364|183313290|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
91710343|NCT02223364|183313291|SUPERIORITY|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
91710344|NCT02223364|183313291|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91710345|NCT02223364|183313291|SUPERIORITY|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||||||0.214
91710346|NCT02223364|183313292|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
91710347|NCT02223364|183313292|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
91710348|NCT02223364|183313292|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
91710349|NCT02223364|183313293|SUPERIORITY|||||||0.958|||||||Wilcoxon (Mann-Whitney)|||||||0.958
91710350|NCT02223364|183313293|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
91710351|NCT02223364|183313293|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
91710352|NCT02223364|183313294|SUPERIORITY|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.493
91710353|NCT02223364|183313294|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
91710354|NCT02223364|183313294|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||||||0.797
91611044|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.4|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||18.3|-3.4|
91611045|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|-2.9|20.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||20.3|-2.9|
91611046|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|7.2|||||TWO_SIDED|95.0|-4.6|18.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.9|-4.6|
91611047|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|-6.6|16.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||16.8|-6.6|
91611048|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.6|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||18.3|-3.6|
91654373|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.35||||0.0222|TWO_SIDED|95.0|-0.65|-0.05||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.050|-0.650|0.0222
91654374|NCT02637557|183201456|SUPERIORITY||LS Mean Difference|-0.482||||0.0019|TWO_SIDED|95.0|-0.785|-0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.180|-0.785|0.0019
91789142|NCT00711516|183458450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0499|TWO_SIDED|95.0|-5.8|0.0||Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.|ANCOVA|||Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was \<= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were \<= 0.05. If any were \>0.05 subsequent p-values would be reported as nominal p-values.||-0.0|-5.8|0.0499
91789143|NCT00711516|183458451|SUPERIORITY_OR_OTHER|||||||0.7343||95.0|||||Fisher Exact|||||||0.7343
91611049|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-5.6|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||21.6|-5.6|
91611050|NCT02926573|183115946|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|-3.5|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||23.8|-3.5|
91611051|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-0.9|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||22.3|-0.9|
91611052|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|9.1|||||TWO_SIDED|95.0|-3.4|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||21.6|-3.4|
91611053|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|6.3|||||TWO_SIDED|95.0|-6.1|18.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.6|-6.1|
91611054|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-7.3|17.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||17.8|-7.3|
91611055|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|11.2|||||TWO_SIDED|95.0|-1.4|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||23.8|-1.4|
91611056|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|14.9|||||TWO_SIDED|95.0|-0.1|29.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||29.9|-0.1|
91611057|NCT02926573|183115947|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|-2.8|26.0|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||26.0|-2.8|
91611058|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-14.7|11.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||11.9|-14.7|
91611059|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-8.6|19.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||19.2|-8.6|
91611060|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|10.9|||||TWO_SIDED|95.0|-2.4|24.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||24.2|-2.4|
91611061|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-6.6|20.7|||||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|20.7|-6.6|
91611062|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-6.4|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||22.3|-6.4|
91611063|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|15.7|||||TWO_SIDED|95.0|-0.4|31.7|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||31.7|-0.4|
91611064|NCT02926573|183115948|SUPERIORITY||Mean Difference (Final Values)|16.7|||||TWO_SIDED|95.0|0.0|33.4|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||33.4|0.0|
91654375|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|0.143||||0.1922|TWO_SIDED|95.0|-0.072|0.357||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.357|-0.072|0.1922
91710355|NCT02223364|183313295|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
91710356|NCT02223364|183313295|SUPERIORITY|||||||0.991|||||||Wilcoxon (Mann-Whitney)|||||||0.991
91523833|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.352
91710357|NCT02223364|183313295|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
91654376|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|0.072||||0.5091|TWO_SIDED|95.0|-0.143|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.288|-0.143|0.5091
91611065|NCT03240081|183116000|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when defining and evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.08|TWO_SIDED|||||Threshold for significance \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.08
91611066|NCT03240081|183116001|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.95|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.95
91611067|NCT00949650|183116002|SUPERIORITY_OR_OTHER|||||||0.0002||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0002
91611068|NCT00949650|183116002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576||||0.0002||95.0|0.426|0.778|||Regression, Cox|Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.|Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.|||0.778|0.426|0.0002
91611069|NCT00949650|183116003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.802|||<|0.0001||95.0|2.855|8.075|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||8.075|2.855|<0.0001
91611070|NCT00949650|183116004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.288||||0.0118||95.0|1.202|4.356|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||4.356|1.202|0.0118
91611071|NCT00949650|183116005|SUPERIORITY_OR_OTHER|||||||0.7916||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.7916
91611072|NCT00949650|183116005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.385||95.0|0.66|1.174|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||1.174|0.660|0.3850
91611073|NCT00949650|183116006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82|||<|0.0001||95.0|-13.64|-5.99|||ANCOVA|Adjusted for baseline SoD, EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||-5.99|-13.64|<0.0001
91611074|NCT00949650|183116009|SUPERIORITY_OR_OTHER|||||||0.0062||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0062
91611075|NCT00949650|183116009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.589||||0.2133||95.0|0.401|0.866|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.866|0.401|0.2133
91611076|NCT00949650|183116010|SUPERIORITY_OR_OTHER|||||||0.0129||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0129
91611077|NCT00949650|183116010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0078||95.0|0.499|0.927|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.927|0.499|0.0078
91611078|NCT00949650|183116011|SUPERIORITY_OR_OTHER|||||||0.1882||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.1882
91611079|NCT00949650|183116011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.0427||95.0|0.618|1.104|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||1.104|0.618|0.0427
91611080|NCT01678846|183116022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.64|||Regression, Logistic||An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.|Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.||0.64|0.26|<0.0001
91611081|NCT03322657|183116026|SUPERIORITY||Hazard Ratio (HR)|3.8|||<|0.001|TWO_SIDED|95.0|2.2|6.5|||Cox proportional hazard model|||||6.5|2.2|<0.001
91611082|NCT03322657|183116027|SUPERIORITY||Median Difference (Final Values)|6.3||||0.13|TWO_SIDED|95.0|-2.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-2.0|0.13
91611083|NCT03322657|183116028|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.34|||Cox proportional hazard model|||||1.34|0.43|0.30
91611084|NCT03322657|183116029|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.35|1.0|||t-test, 2 sided|||||1.00|-0.35|0.21
91523834|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.636
91654377|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|0.037||||0.7394|TWO_SIDED|95.0|-0.181|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.254|-0.181|0.7394
91611085|NCT03322657|183116030|SUPERIORITY||Mean Difference (Final Values)|0.82||||0.04|TWO_SIDED|95.0|-0.18|1.81|||t-test, 2 sided|||||1.81|-0.18|0.04
91611086|NCT03249350|183116034|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.49|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.49
91611087|NCT03249350|183116035|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.19||0.92|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.92
91611088|NCT03249350|183116036|SUPERIORITY||||||<|0.001|||||||ANOVA|Main effect of group, F=13.58.||Cognitive Behavioral Components||||<0.001
91611089|NCT03249350|183116036|SUPERIORITY|||||||0.08|||||||ANOVA|Main effect of group, F=3.02.||Behavioral Modification Components||||0.08
91611090|NCT03249350|183116037|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.09|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.09
91611091|NCT03249350|183116038|SUPERIORITY||Slope|-0.004|STANDARD_ERROR_OF_MEAN|0.06||0.95|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.95
91611092|NCT03249350|183116039|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.88|TWO_SIDED||||||Mixed Models Analysis|||APQ - Poor Monitoring - Parent Report Mixed effects regression model tested for between-group differences in change over time.||||0.88
91611093|NCT03249350|183116040|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.06|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.06
91611094|NCT03249350|183116041|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.5|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.50
91654378|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|0.073||||0.5845|TWO_SIDED|95.0|-0.189|0.334||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.334|-0.189|0.5845
91523835|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.880
91523836|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.904||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.904
91611095|NCT03249350|183116042|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.15||0.03|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.03
91611096|NCT03249350|183116043|SUPERIORITY||Slope|-0.21|STANDARD_ERROR_OF_MEAN|0.33||0.54|TWO_SIDED||||||Mixed Models Analysis|||GAIN - Substance Frequency Mixed effects regression model tested for between-group differences in change over time.||||0.54
91611097|NCT03249350|183116044|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.89|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.89
91611098|NCT03249350|183116045|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.31|TWO_SIDED||||||Mixed Models Analysis|||BISBAS Drive - Youth Report. Mixed effects regression model tested for between-group differences in change over time.||||0.31
91611099|NCT03249350|183116046|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05||0.35|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.35
91611100|NCT03249350|183116047|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.05||0.13|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.13
91611101|NCT03249350|183116048|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.30
91611102|NCT03249350|183116049|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.70
91611103|NCT03249350|183116050|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.89|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.89
91611104|NCT03249350|183116051|SUPERIORITY||Slope|-0.5|STANDARD_ERROR_OF_MEAN|0.27||0.06|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.06
91611105|NCT03249350|183116052|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.11|TWO_SIDED||||||Mixed Models Analysis|||EATQ Effortful Control - Youth Report Mixed effects regression model tested for between-group differences in change over time.||||0.11
91611106|NCT03249350|183116053|SUPERIORITY||Slope|-0.0001|STANDARD_ERROR_OF_MEAN|0.009||0.99|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.99
91611107|NCT03249350|183116054|SUPERIORITY||Slope|-0.0007|STANDARD_ERROR_OF_MEAN|0.003||0.82|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.82
91611108|NCT03249350|183116055|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|0.21||0.23|TWO_SIDED||||||Mixed Models Analysis|||Peer Delinquency||||0.23
91611109|NCT03249350|183116056|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.73|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.73
91654379|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.034||||0.7959|TWO_SIDED|95.0|-0.296|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.228|-0.296|0.7959
91523837|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.859
91611110|NCT03249350|183116057|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.11||0.31|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression model tested for between-group differences in change over time.||||0.31
91611111|NCT00553787|183116064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|0.328|<|0.0001|TWO_SIDED|95.0|7.96|9.25||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.25|7.96|<0.0001
91611112|NCT00553787|183116064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|0.403|<|0.0001|TWO_SIDED|95.0|5.79|7.37||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.37|5.79|<0.0001
91611113|NCT00553787|183116064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_ERROR_OF_MEAN|0.402|<|0.0001|TWO_SIDED|95.0|1.24|2.82||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||2.82|1.24|<0.0001
91611114|NCT00553787|183116065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.03|STANDARD_ERROR_OF_MEAN|0.955|<|0.0001|TWO_SIDED|95.0|7.34|11.11||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||11.11|7.34|<0.0001
91611115|NCT00553787|183116065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.27|STANDARD_ERROR_OF_MEAN|0.768|<|0.0001|TWO_SIDED|95.0|4.93|7.97||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.97|4.93|<0.0001
91611116|NCT00553787|183116065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.169||0.0018|TWO_SIDED|95.0|1.15|1.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||1.81|1.15|0.0018
91611117|NCT00149825|183116074|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|This is a one-tailed test||We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression||||.13
91611118|NCT00149825|183116075|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.||||.05
91523838|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.654
91611119|NCT00435539|183116202|SUPERIORITY_OR_OTHER|||||||0.4783|||||||Fisher Exact|||||||0.4783
91611120|NCT00435539|183116202|SUPERIORITY_OR_OTHER|||||||0.0932|||||||Fisher Exact|||||||0.0932
91611121|NCT00435539|183116202|SUPERIORITY_OR_OTHER|||||||0.0721|||||||Fisher Exact|||||||0.0721
91611122|NCT00435539|183116203|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
91611123|NCT00435539|183116203|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
91611124|NCT00435539|183116203|SUPERIORITY_OR_OTHER|||||||0.5343|||||||Fisher Exact|||||||0.5343
91611125|NCT02773758|183116291|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.509|-1.071|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.071|-1.509|<0.0001
91611126|NCT00611455|183116322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.67|4.91|||Cochran-Mantel-Haenszel|||||4.91|1.67|<0.001
91611127|NCT04382651|183116378|SUPERIORITY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|2.225||0.33|TWO_SIDED|90.0|-2.7|4.7||1-Sided|ANCOVA|||||4.7|-2.7|0.33
91611128|NCT01507545|183116394|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7335|TWO_SIDED|95.0|0.76|1.67|||One-sided log-rank test|||||1.67|0.76|0.7335
91611129|NCT01507545|183116395|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.9498|TWO_SIDED|95.0|0.93|2.19|||One-sided log-rank test|||||2.19|0.93|0.9498
91611130|NCT01507545|183116396|SUPERIORITY||Difference of arms|-2.4||||0.333|TWO_SIDED|95.0|-6.992|2.23|||Fisher Exact|||||2.230|-6.992|0.333
91611131|NCT01753518|183116413|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
91611132|NCT01753518|183116414|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
91611133|NCT01753518|183116415|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||Comparison for staple expulsion or suture trimming||||0.25
91611134|NCT01753518|183116415|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||Comparison for Surgical Site Infection||||0.06
91611135|NCT01753518|183116415|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||Comparison for Superficial Wound Separation||||0.21
91611136|NCT01753518|183116415|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Fisher Exact|||Comparison for Seroma||||0.49
91611137|NCT01753518|183116415|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Fisher Exact|||Comparison for Hematoma||||0.50
91611138|NCT01753518|183116416|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Tylenol use.||||0.48
91611139|NCT01753518|183116416|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Ibuprofen use.||||0.30
91611140|NCT01753518|183116416|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Toradol use.||||0.85
91611141|NCT01753518|183116416|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Oxycodone use.||||0.78
91611142|NCT01753518|183116418|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||"Comparison for negative responses to Appearance of incision question."||||0.51
91654380|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.015||||0.9086|TWO_SIDED|95.0|-0.28|0.249||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.249|-0.280|0.9086
91523839|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.566
91611143|NCT01753518|183116418|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Chi-squared|||"Comparison for negative responses to Would recommend treatment to friends question."||||0.098
91611144|NCT01753518|183116418|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||"Comparison of negative responses to Willingness to use treatment again question."||||0.57
91611145|NCT01753518|183116418|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Fisher Exact|||"Comparison of negative responses to Overall satisfaction question."||||0.41
91611146|NCT01753518|183116419|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Chi-squared|||"Comparison between arms for appearance of incision."||||0.85
91611147|NCT01753518|183116419|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Chi-squared|||"Comparison between arms for recommend treatment."||||0.004
91611148|NCT01753518|183116419|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"Comparison between arms for willingness to use treatment again."||||<0.001
91611149|NCT01753518|183116420|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91611150|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar painful.||||0.35
91611151|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar itching.||||0.48
91611152|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar color is different.||||0.034
91611153|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar stiffness is different.||||0.041
91611154|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar thickness is different.||||0.23
91611155|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar more irregular.||||0.13
91611156|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: overall opinion.||||0.11
91611157|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: vascularity.||||0.68
91611158|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pigmentation.||||0.18
91611159|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: thickness||||0.75
91611160|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: relief.||||0.36
91611161|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pliability.||||0.78
91611162|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: surface area.||||0.76
91611163|NCT01753518|183116421|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: overall opinion.||||0.97
91611164|NCT00514449|183116445|OTHER||number of voxels in a cluster|2037.0||||0.004|TWO_SIDED|||||p value is adjusted for multiple comparisons|ANCOVA||Time by treatment group interaction term|||||0.004
91611165|NCT04083144|183116447|SUPERIORITY||η2|0.01||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
91611166|NCT04083144|183116448|SUPERIORITY||η2|0.16||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
91611167|NCT04083144|183116449|SUPERIORITY||η2|0.02||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
91611168|NCT04083144|183116450|SUPERIORITY||η2|0.07||||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
91654381|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.08||||0.5334|TWO_SIDED|95.0|-0.333|0.173||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.173|-0.333|0.5334
91654382|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.212||||0.102|TWO_SIDED|95.0|-0.466|0.042||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.042|-0.466|0.1020
91654383|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.357||||0.0066|TWO_SIDED|95.0|-0.613|-0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.100|-0.613|0.0066
91611169|NCT04083144|183116451|SUPERIORITY||η2|0.17||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
91611170|NCT02708212|183116466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.||||<0.0001
91611171|NCT02708212|183116467|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of midazolam between the two study groups.||||0.0012
91611172|NCT02708212|183116468|SUPERIORITY_OR_OTHER|||||||0.6967|||||||t-test, 2 sided|||||||0.6967
91611173|NCT04458857|183116489|OTHER||LS mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|-1.9|-0.16|||ANCOVA|||||-0.16|-1.90|0.0210
91611174|NCT01748695|183116529|SUPERIORITY_OR_OTHER|||||||0.834||||||Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.|Regression, Linear|||||||0.834
91611175|NCT01333189|183116532|SUPERIORITY_OR_OTHER||||||=|0.329|TWO_SIDED||||||Mixed Models Analysis|||||||=0.329
91611176|NCT01333189|183116533|SUPERIORITY_OR_OTHER||||||=|0.891|TWO_SIDED||||||Mixed Models Analysis|||||||=0.891
91611177|NCT01333189|183116534|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
91611178|NCT01333189|183116535|SUPERIORITY_OR_OTHER||||||=|0.509|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.509
91611179|NCT01333189|183116535|SUPERIORITY_OR_OTHER||||||=|0.5|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.500
91611180|NCT01333189|183116535|SUPERIORITY_OR_OTHER||||||=|0.607|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.607
91611181|NCT01333189|183116536|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
91611182|NCT01333189|183116537|SUPERIORITY_OR_OTHER||||||=|0.48|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.480
91611183|NCT01333189|183116537|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.120
91611184|NCT01333189|183116537|SUPERIORITY_OR_OTHER||||||=|0.668|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.668
91611185|NCT01333189|183116538|SUPERIORITY_OR_OTHER||||||=|0.511|TWO_SIDED||||||Mixed Models Analysis|||||||=0.511
91611186|NCT01333189|183116539|SUPERIORITY_OR_OTHER||||||=|0.402|TWO_SIDED||||||Mixed Models Analysis|||||||=0.402
91611187|NCT01333189|183116540|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
91611188|NCT01333189|183116541|SUPERIORITY_OR_OTHER||||||=|0.686|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.686
91611189|NCT01333189|183116541|SUPERIORITY_OR_OTHER||||||=|0.434|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.434
91611190|NCT01333189|183116541|SUPERIORITY_OR_OTHER||||||=|0.227|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.227
91611191|NCT01333189|183116542|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
91611192|NCT01333189|183116543|SUPERIORITY_OR_OTHER||||||=|0.16|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.160
91611193|NCT01333189|183116543|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.008
91611194|NCT01333189|183116543|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.877
91611195|NCT00969618|183116570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for total ADHD symptoms score.|Paired t-test|||||||<0.001
91611196|NCT00969618|183116570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for inattention subscale score.|Paired t-test|||||||<0.001
91611197|NCT00969618|183116570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for hyperactivity/impulsivity subscale score.|Paired t-test|||||||<0.001
91611198|NCT00969618|183116570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for ADHD index subscale score.|Paired t-test|||||||<0.001
91611199|NCT00969618|183116571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
91611200|NCT00969618|183116572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is GEC subscale score.|Paired t-test|||||||<0.001
91611201|NCT00969618|183116572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
91611202|NCT00969618|183116572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
91611203|NCT00969618|183116573|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Paired t-test|||||||0.200
91611204|NCT00969618|183116574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
91611205|NCT00969618|183116575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GEC subscale score.|Paired t-test|||||||<0.001
91611206|NCT00969618|183116575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
91611207|NCT00969618|183116575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
91611208|NCT00969618|183116576|SUPERIORITY_OR_OTHER|||||||0.384||95.0|||||Paired t-test|||||||0.384
91611209|NCT01894516|183116581|SUPERIORITY||Difference in percentage rates|37.5|||<|0.0001|TWO_SIDED|95.0|22.4|52.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||52.6|22.4|< 0.0001
91611210|NCT01894516|183116581|SUPERIORITY||Difference in percentage rates|36.5|||<|0.0001|TWO_SIDED|95.0|21.3|51.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||51.8|21.3|< 0.0001
91710358|NCT02223364|183313296|SUPERIORITY|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||||||0.807
91611211|NCT01894516|183116581|SUPERIORITY||Difference in percentage rates|43.3|||<|0.0001|TWO_SIDED|95.0|28.4|58.2||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||58.2|28.4|< 0.0001
91611212|NCT05652660|183116593|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|120.5|||||TWO_SIDED|90.0|104.77|138.59|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||138.59|104.77|
91611213|NCT05652660|183116594|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|110.56|||||TWO_SIDED|90.0|103.53|118.06|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.06|103.53|
91611214|NCT03191396|183116620|NON_INFERIORITY|HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.|Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56||The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.|ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.||-0.56|-0.82|<0.0001
91611215|NCT03191396|183116620|SUPERIORITY||Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-0.56|-0.82|<0.0001
91611216|NCT03191396|183116621|SUPERIORITY||Treatment difference|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.57|-3.09|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-3.09|-4.57|<0.0001
91611217|NCT01240811|183116666|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
91611218|NCT01240811|183116666|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
91611219|NCT01240811|183116667|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||Difference in paired change in Nugent score from baseline to 2 months||||0.08
91611220|NCT01240811|183116668|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Change in quantity of H2O2 producing Lactobacilli species by qPCR||||0.46
91710359|NCT02223364|183313296|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
91710360|NCT02223364|183313296|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
91523840|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.926
91611221|NCT01240811|183116668|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Change in quantity of Garnerella vaginalis species by qPCR||||0.62
91611222|NCT03990766|183116675|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-35.6|42.3||||||||42.3|-35.6|
91611223|NCT03990766|183116676|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-3.0|5.0||||||||5|-3|
91611224|NCT03990766|183116677|SUPERIORITY||Median Difference (Net)|-10.0|||||TWO_SIDED|95.0|-15.0|-4.0||||||The within-subject change in QOD-NS scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort.||-4|-15|
91611225|NCT03990766|183116678|SUPERIORITY||Median Difference (Net)|7.0|||||TWO_SIDED|95.0|-2.0|17.0||||||The within-subject change in ODOR scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort. We confirmed the reported results.||17|-2|
91611226|NCT03726671|183116679|OTHER|||||||0.0247|||||||Repeated measures ANOVA|||Betaine IER||||0.0247
91611227|NCT03726671|183116679|OTHER||||||<|0.0001|||||||Repeated measures ANOVA|||Choline IER||||<0.0001
91611228|NCT03726671|183116679|OTHER|||||||0.0002|||||||Repeated measures ANOVA|||Phosphatidylcholine IER||||0.0002
91611229|NCT03726671|183116680|OTHER||Odds Ratio (OR)|7.16|||<|0.001|TWO_SIDED|95.0|3.48|14.7|||Fisher Exact|||||14.7|3.48|<0.001
91611230|NCT03726671|183116680|OTHER||Odds Ratio (OR)|4.09||||0.01|TWO_SIDED|95.0|2.06|8.11|||Fisher Exact|||||8.11|2.06|0.01
91611231|NCT03726671|183116680|OTHER||Odds Ratio (OR)|1.75||||0.086|TWO_SIDED|95.0|0.86|3.58|||Fisher Exact|||||3.58|0.86|0.086
91710361|NCT02223364|183313298|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91710362|NCT02223364|183313298|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91710363|NCT02223364|183313298|SUPERIORITY|||||||0.293|||||||Wilcoxon (Mann-Whitney)|||||||0.293
91710364|NCT02223364|183313299|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
91710365|NCT02223364|183313299|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91710366|NCT02223364|183313299|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
91710367|NCT02223364|183313300|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
91710368|NCT02223364|183313300|SUPERIORITY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
91710369|NCT02223364|183313300|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
91710370|NCT02223364|183313301|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
91710371|NCT02223364|183313302|SUPERIORITY|||||||0.623|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.623
91611232|NCT03726671|183116681|OTHER|||||||0.6985|||||||t-test, 2 sided|||Betaine IER||||0.6985
91710372|NCT02223364|183313302|SUPERIORITY|||||||0.001|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.001
91611233|NCT03726671|183116681|OTHER|||||||0.035|||||||t-test, 2 sided|||Choline IER||||0.0350
91611234|NCT03726671|183116681|OTHER|||||||0.6864|||||||t-test, 2 sided|||Phosphatidylcholine IER||||0.6864
91611235|NCT03726671|183116682|EQUIVALENCE|There are linear combinations of metabolites that differentiate (non-equivalent) the 25% choline diet from the 100% choline diet.|||||<|0.049|||||||Paired 2-sided t-test||||Supervised OPLSDA was used to determine the variable importance to projections of metabolites/signals that differentiated the 25% and 100% choline diet arms.|||<0.049
91611236|NCT03726671|183116683|OTHER|||||||0.9567|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Pre-Menopausal Females||||0.9567
91611237|NCT03726671|183116683|OTHER|||||||0.0899|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Post-Menopausal Females||||0.0899
91611238|NCT03726671|183116683|OTHER|||||||0.9003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Males||||0.9003
91611239|NCT03726671|183116683|OTHER|||||||0.9932|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Pre-Menopausal Females||||0.9932
91611240|NCT03726671|183116683|OTHER|||||||0.3984|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Post-Menopausal Females||||0.3984
91710373|NCT02223364|183313302|SUPERIORITY|||||||0.048|||||||Regression, Cox|||Within group comparison of baseline and three months (approximately 12 weeks)||||0.048
91523841|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.902
91611241|NCT03726671|183116683|OTHER|||||||0.308|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Males||||0.3080
91523842|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.766
91611242|NCT03726671|183116683|OTHER|||||||0.7603|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.7603
91611243|NCT03726671|183116683|OTHER|||||||0.2995|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.2995
91611244|NCT03726671|183116683|OTHER|||||||0.0003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Males||||0.0003
91611245|NCT03726671|183116683|OTHER|||||||0.1303|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Pre-Menopausal Females||||0.1303
91710374|NCT02685072|183313315|SUPERIORITY||Odds Ratio (OR)|0.5818||||0.3253|TWO_SIDED|95.0|0.1968|1.7202|||Chi-squared|degrees of freedom =1|Odds ratio represents odds of smoking abstinence in TPN + progesterone group versus TPN + placebo group|||1.7202|0.1968|0.3253
91710375|NCT02685072|183313316|SUPERIORITY||Odds Ratio (OR)|1.0781||||0.8944|TWO_SIDED|95.0|0.355|3.2744|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 (negative for smoking) in TPN + progesterone versus TPN + placebo groups|||3.2744|0.3550|0.8944
91710376|NCT02685072|183313317|SUPERIORITY||Odds Ratio (OR)|0.7619||||0.662|TWO_SIDED|95.0|0.2247|2.5838|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.5838|0.2247|0.6620
91710377|NCT02685072|183313318|SUPERIORITY||Odds Ratio (OR)|0.913||||0.8661|TWO_SIDED|95.0|0.3171|2.6287|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.6287|0.3171|0.8661
91710378|NCT02685072|183313319|SUPERIORITY||Mean Difference (Final Values)|-9.1|STANDARD_DEVIATION|31.7||0.31|TWO_SIDED|95.0|-27.1|9.0|||t-test, 2 sided||(Placebo + TPN) - (Progesterone + TPN)|||9.0|-27.1|0.31
91611246|NCT03726671|183116683|OTHER|||||||0.0015|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Post-Menopausal Females||||0.0015
91611247|NCT03726671|183116683|OTHER|||||||0.4185|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Males||||0.4185
91611248|NCT03726671|183116683|OTHER|||||||0.3464|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Pre-Menopausal Females||||0.3464
91611249|NCT03726671|183116683|OTHER|||||||0.0019|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Post-Menopausal Females||||0.0019
91611250|NCT03726671|183116683|OTHER|||||||0.2091|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Males||||0.2091
91611251|NCT03726671|183116683|OTHER|||||||0.8141|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.8141
91611252|NCT03726671|183116683|OTHER|||||||0.0187|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.0187
91611253|NCT03726671|183116683|OTHER|||||||0.0107|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Males||||0.0107
91710379|NCT02685072|183313320|SUPERIORITY||Mean Difference (Final Values)|0.148||||0.791|TWO_SIDED|95.0|-0.9747|1.2707|||t-test, 2 sided||(placebo + TPN) - (progesterone + TPN)|||1.2707|-0.9747|0.7910
91611254|NCT03726671|183116684|OTHER|||||||0.0842|||||||Mixed Models Analysis|||||||0.0842
91611255|NCT03726671|183116684|OTHER|||||||0.0819|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.0819
91611256|NCT03726671|183116684|OTHER|||||||0.9015|||||||t-test, 2 sided|||||||0.9015
91611257|NCT03726671|183116684|OTHER|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.1191
91523843|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.449
91523844|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.797
91611258|NCT03726671|183116685|OTHER|||||||0.2351|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. betaine IER||||0.2351
91611259|NCT03726671|183116685|OTHER|||||||0.4501|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4501
91611260|NCT03726671|183116685|OTHER|||||||0.4136|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.4136
91611261|NCT03726671|183116685|OTHER|||||||0.9463|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.9463
91611262|NCT03726671|183116685|OTHER|||||||0.0675|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.0675
91611263|NCT03726671|183116685|OTHER|||||||0.2863|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.2863
91611264|NCT03726671|183116685|OTHER|||||||0.5552|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.5552
91611265|NCT03726671|183116685|OTHER|||||||0.4209|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4209
91611266|NCT03726671|183116685|OTHER|||||||0.6647|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.6647
91613561|NCT00257192|183121429|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-2.57|STANDARD_ERROR_OF_MEAN|2.0||0.1987||95.0|-6.5|1.36||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Total score: difference from placebo||1.36|-6.50|0.1987
91613562|NCT00257192|183121430|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.33|STANDARD_ERROR_OF_MEAN|0.65||0.0412|TWO_SIDED|95.0|-2.61|-0.05||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Positive score: difference from placebo||-0.05|-2.61|0.0412
91710380|NCT02685072|183313321|SUPERIORITY||Mean Difference (Final Values)|9.26||||0.0065|TWO_SIDED|95.0|2.71|15.81|||t-test, 2 sided|||||15.81|2.71|0.0065
91710381|NCT02685072|183313332|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|.6449
91611267|NCT04192448|183116687|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|1.82||||0.28|TWO_SIDED|95.0|-29.82|26.19|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of sexual aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||26.19|-29.82|.28
91611268|NCT04192448|183116687|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-1.0||||0.39|TWO_SIDED|95.0|-33.01|35.01|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of sexual aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||35.01|-33.01|.39
91611269|NCT04192448|183116688|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.25||||0.33|TWO_SIDED|95.0|-2.88|2.63|||t-test, 1 sided|This t-test examined the difference in physical aggression intentions between those in the Alcohol Condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of physical aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.63|-2.88|.33
91611270|NCT04192448|183116688|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.25||||0.33|TWO_SIDED|95.0|-2.53|2.88|||t-test, 1 sided|The t-test examined the difference in physical aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of physical aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.88|-2.53|.33
91611271|NCT04192448|183116689|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.67||||0.23|TWO_SIDED|95.0|-8.0|6.67|||t-test, 1 sided|The t-test examined differences in psychological aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of psych aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||6.67|-8.00|.23
91613563|NCT00257192|183121430|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|0.58||0.4661|TWO_SIDED|95.0|-1.57|0.72||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Negative score: difference from placebo||0.72|-1.57|0.4661
91523845|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.438
91523846|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.602
91523847|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.493||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.493
91523848|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.335||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.335
91523849|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.398||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.398
91523850|NCT00279201|182923094|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.903
91613564|NCT00257192|183121431|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.182|TWO_SIDED|95.0|-0.47|0.09||Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.|ANOVA|||Difference from placebo||0.09|-0.47|0.1820
91523851|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Hypoglycemia episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
91523852|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
91523853|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.188
91523854|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.226
91523855|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.855||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.855
91523856|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value is for Hypoglycemia episodes at endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.250
91523857|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.123
91611272|NCT04192448|183116689|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.17||||0.44|TWO_SIDED|95.0|-10.84|11.17|||t-test, 1 sided|The t-test examined the difference in psychological aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A negative value indicates greater likelihood of psych aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||11.17|-10.84|.44
91611273|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||<0.0001
91611274|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
91611275|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
91611276|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
91611277|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
91611278|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.0001
91611279|NCT00500149|183116694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
91611280|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||< 0.0001
91611281|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
91611282|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
91654384|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.127||||0.3586|TWO_SIDED|95.0|-0.399|0.145||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.145|-0.399|0.3586
91654385|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.348||||0.0128|TWO_SIDED|95.0|-0.621|-0.075||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.075|-0.621|0.0128
91654386|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.384||||0.0064|TWO_SIDED|95.0|-0.66|-0.109||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.109|-0.660|0.0064
91654387|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.076||||0.6124|TWO_SIDED|95.0|-0.369|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.218|-0.369|0.6124
91654388|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.223||||0.1365|TWO_SIDED|95.0|-0.518|0.071||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.071|-0.518|0.1365
91654389|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.355||||0.0193|TWO_SIDED|95.0|-0.652|-0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.058|-0.652|0.0193
91654390|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.037||||0.8046|TWO_SIDED|95.0|-0.333|0.258||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.258|-0.333|0.8046
91789144|NCT00711516|183458452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2||||0.1246|TWO_SIDED|95.0|-1.8|14.3||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.|ANCOVA|||||14.3|-1.8|0.1246
91654391|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.319||||0.035|TWO_SIDED|95.0|-0.616|-0.023||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.023|-0.616|0.0350
91654392|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.392||||0.0105|TWO_SIDED|95.0|-0.691|-0.093||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.093|-0.691|0.0105
91654393|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.094||||0.5482|TWO_SIDED|95.0|-0.403|0.214||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.214|-0.403|0.5482
91654394|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.377||||0.017|TWO_SIDED|95.0|-0.687|-0.068||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.068|-0.687|0.0170
91654395|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.469||||0.0034|TWO_SIDED|95.0|-0.781|-0.157||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.157|-0.781|0.0034
91654396|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.093||||0.5346|TWO_SIDED|95.0|-0.388|0.202||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.202|-0.388|0.5346
91654397|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.336||||0.0262|TWO_SIDED|95.0|-0.632|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.040|-0.632|0.0262
91789145|NCT00711516|183458453|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.026||||0.7382|TWO_SIDED|95.0|-21.684|19.98|||Wilcoxon (Mann-Whitney)|||||19.980|-21.684|0.7382
91789146|NCT00711516|183458454|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.086||||1|TWO_SIDED|95.0|-19.195|25.043|||Wilcoxon (Mann-Whitney)|||||25.043|-19.195|1.000
91789147|NCT00711516|183458455|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.282||||0.8861|TWO_SIDED|95.0|-11.46|14.77|||Wilcoxon (Mann-Whitney)|||||14.770|-11.460|0.8861
91789148|NCT00711516|183458456|SUPERIORITY_OR_OTHER||Median Difference (Net)|11.825||||0.4738|TWO_SIDED|95.0|-12.601|37.987|||Wilcoxon (Mann-Whitney)|||||37.987|-12.601|0.4738
91789149|NCT00711516|183458457|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test||||0.0573
91789150|NCT00711516|183458457|SUPERIORITY_OR_OTHER|||||||0.0754||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.0754
91789151|NCT00711516|183458458|SUPERIORITY_OR_OTHER|||||||0.2727||95.0|||||Pearson's Correlation Coefficient|||||||0.2727
91789152|NCT00711516|183458458|SUPERIORITY_OR_OTHER|||||||0.5671||95.0|||||Pearson's Correlation Coefficient|||||||.5671
91789153|NCT00711516|183458459|SUPERIORITY_OR_OTHER|||||||0.1169||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1169
91789154|NCT00711516|183458459|SUPERIORITY_OR_OTHER|||||||0.1634||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1634
91789155|NCT00711516|183458460|SUPERIORITY_OR_OTHER|||||||0.0692||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.0692
91789156|NCT00711516|183458460|SUPERIORITY_OR_OTHER|||||||0.8876||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.8876
91789157|NCT00711516|183458461|SUPERIORITY_OR_OTHER|||||||0.603||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.6030
91611283|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
91611284|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
91611285|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.001
91611286|NCT00500149|183116695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
91611287|NCT01157169|183116696|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.49|||||TWO_SIDED|90.0|101.67|120.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.07|101.67|
91611288|NCT01157169|183116697|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.91|||||TWO_SIDED|90.0|99.74|112.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.45|99.74|
91611289|NCT01157169|183116698|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.97|||||TWO_SIDED|90.0|97.18|111.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.24|97.18|
91611290|NCT01157169|183116699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.28|||||TWO_SIDED|90.0|85.37|101.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.93|85.37|
91611291|NCT01157169|183116700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|87.44|101.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.46|87.44|
91611292|NCT01157169|183116701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.06|||||TWO_SIDED|90.0|86.56|104.39|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.39|86.56|
91654398|NCT02637557|183201457|SUPERIORITY||LS Mean Difference|-0.545||||0.0004|TWO_SIDED|95.0|-0.843|-0.246||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.246|-0.843|0.0004
91789158|NCT00711516|183458461|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||<.0001
91789159|NCT00711516|183458462|SUPERIORITY_OR_OTHER|||||||0.917||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.9170
91789160|NCT00711516|183458462|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.9642
91789161|NCT00711516|183458463|SUPERIORITY_OR_OTHER|||||||0.7813||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.7813
91789162|NCT00711516|183458463|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1560
91654399|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|0.098||||0.3007|TWO_SIDED|95.0|-0.088|0.284||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.284|-0.088|0.3007
91654400|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|0.143||||0.1295|TWO_SIDED|95.0|-0.042|0.328||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.328|-0.042|0.1295
91654401|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.028||||0.7671|TWO_SIDED|95.0|-0.216|0.159||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.159|-0.216|0.7671
91654402|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|0.01||||0.9308|TWO_SIDED|95.0|-0.217|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.238|-0.217|0.9308
91654403|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|0.051||||0.6595|TWO_SIDED|95.0|-0.176|0.277||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.277|-0.176|0.6595
91654404|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.127||||0.2771|TWO_SIDED|95.0|-0.356|0.102||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.102|-0.356|0.2771
91654405|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.203||||0.0887|TWO_SIDED|95.0|-0.436|0.031||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.031|-0.436|0.0887
91654406|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.21||||0.0758|TWO_SIDED|95.0|-0.443|0.022||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.022|-0.443|0.0758
91789163|NCT00711516|183458464|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.9010
91654407|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.298||||0.0132|TWO_SIDED|95.0|-0.534|-0.063||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.063|-0.534|0.0132
91654408|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.086||||0.4903|TWO_SIDED|95.0|-0.332|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.160|-0.332|0.4903
91789164|NCT00711516|183458464|SUPERIORITY_OR_OTHER|||||||0.0135||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.0135
91789165|NCT00711516|183458473|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.841||||0.7053|TWO_SIDED|95.0|-27.778|19.313|||Wilcoxon (Mann-Whitney)|||||19.313|-27.778|0.7053
91654409|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.068||||0.5824|TWO_SIDED|95.0|-0.313|0.176||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.176|-0.313|0.5824
91654410|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.215||||0.0885|TWO_SIDED|95.0|-0.463|0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.033|-0.463|0.0885
91654411|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.111||||0.3652|TWO_SIDED|95.0|-0.352|0.13||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.130|-0.352|0.3652
91654412|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.108||||0.3739|TWO_SIDED|95.0|-0.348|0.131||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.131|-0.348|0.3739
91654413|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.27||||0.0294|TWO_SIDED|95.0|-0.512|-0.027||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.027|-0.512|0.0294
91654414|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.102||||0.4236|TWO_SIDED|95.0|-0.351|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.351|0.4236
91654415|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.105||||0.4071|TWO_SIDED|95.0|-0.353|0.144||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.144|-0.353|0.4071
91789166|NCT00711516|183458474|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.792||||0.5163|TWO_SIDED|95.0|-30.631|16.19|||Wilcoxon (Mann-Whitney)|||||16.190|-30.631|0.5163
91789167|NCT00711516|183458475|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.108||||0.8711|TWO_SIDED|95.0|-14.341|5.498|||Wilcoxon (Mann-Whitney)|||||5.498|-14.341|0.8711
91789168|NCT00711516|183458476|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.855||||0.1825||95.0|-15.357|25.714|||Wilcoxon (Mann-Whitney)|||||25.714|-15.357|0.1825
91789169|NCT00711516|183458477|SUPERIORITY_OR_OTHER||Median Difference (Net)|-323.5||||0.9282|TWO_SIDED|95.0|-9311.0|2375.5|||Wilcoxon (Mann-Whitney)|||||2375.5|-9311.0|0.9282
91789170|NCT00711516|183458478|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-1069.0|426.0|||Wilcoxon (Mann-Whitney)|||||426.0|-1069.0|1.0000
91789171|NCT00711516|183458479|SUPERIORITY_OR_OTHER||Median Difference (Net)|-82.8||||0.5284|TWO_SIDED|95.0|-788.0|165.5|||Wilcoxon (Mann-Whitney)|||||165.5|-788.0|0.5284
91789172|NCT00711516|183458480|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.8||||0.8997|TWO_SIDED|95.0|-3151.0|1006.5|||Wilcoxon (Mann-Whitney)|||||1006.5|-3151.0|0.8997
91789173|NCT00711516|183458481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.1||||0.1305|TWO_SIDED|95.0|-58.2|8.0|||ANCOVA|||||8.0|-58.2|0.1305
91789174|NCT02692651|183458482|SUPERIORITY|||||||0.195|||||||Chi-squared, Corrected|||||||0.195
91789175|NCT02692651|183458483|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||||||.99
91789176|NCT02692651|183458484|SUPERIORITY|||||||0.999|||||||Chi-squared, Corrected|||||||.999
91789177|NCT03490981|183458485|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.486|TWO_SIDED||||||ANCOVA|||||||.486
91789178|NCT03490981|183458486|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|1.16||0.342|TWO_SIDED||||||ANCOVA|||||||.342
91789179|NCT03490981|183458487|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.31||0.646|TWO_SIDED||||||ANCOVA|||||||.646
91789180|NCT03490981|183458488|SUPERIORITY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.205||0.205|TWO_SIDED||||||ANCOVA|||||||.205
91789181|NCT03490981|183458489|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|2.94||0.492|TWO_SIDED||||||ANCOVA|||||||.492
91789182|NCT03490981|183458490|SUPERIORITY||Mean Difference (Final Values)|4.31|STANDARD_ERROR_OF_MEAN|3.84||0.272|TWO_SIDED||||||ANCOVA|||||||.272
91789183|NCT03490981|183458491|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.82||0.87|TWO_SIDED||||||ANCOVA|||||||.870
91789184|NCT03490981|183458492|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.67||0.57|TWO_SIDED||||||ANCOVA|||||||.570
91789185|NCT01860846|183458511|SUPERIORITY_OR_OTHER||||||=|0.004||||||Baseline vs. 12 months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||=0.004
91789186|NCT01860846|183458512|SUPERIORITY_OR_OTHER||||||=|0.022||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.022
91523858|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.166
91611293|NCT02940886|183116702|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13|||||Mixed Model for Repeated Measurement was used for testing and included the fixed categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.13|-0.13|
91611294|NCT02940886|183116703|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.88||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.88|0.06|
91611295|NCT02940886|183116703|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.91|0.71||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.71|-0.91|
91611296|NCT02940886|183116703|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
91611297|NCT02940886|183116704|SUPERIORITY|||||||0.5695|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.5695
91611298|NCT02940886|183116705|SUPERIORITY|||||||0.3913|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.3913
91710382|NCT02685072|183313333|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of prolonged abstinence in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|0.6449
91710383|NCT03597139|183313342|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.1491|TWO_SIDED|95.0|-1.7|10.9|||ANCOVA|||||10.9|-1.7|0.1491
91710384|NCT03597139|183313343|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.1187|TWO_SIDED|95.0|-1.6|13.9|||ANCOVA|||||13.9|-1.6|0.1187
91789187|NCT01860846|183458513|SUPERIORITY_OR_OTHER||||||=|0.006||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.006
91523859|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.273
91523860|NCT00279201|182923095|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.039
91654416|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.259||||0.0434|TWO_SIDED|95.0|-0.51|-0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.008|-0.510|0.0434
91523861|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.623
91654417|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.103||||0.4172|TWO_SIDED|95.0|-0.354|0.147||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.147|-0.354|0.4172
91710385|NCT03597139|183313344|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.2128|TWO_SIDED|95.0|-3.7|16.5|||ANCOVA|||||16.5|-3.7|0.2128
91710386|NCT03597139|183313345|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.8408|TWO_SIDED|95.0|-11.8|9.6|||ANCOVA|||||9.6|-11.8|0.8408
91710387|NCT03597139|183313346|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.5356|TWO_SIDED|95.0|-6.1|11.6|||ANCOVA|||||11.6|-6.1|0.5356
91710388|NCT03597139|183313347|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.1787|TWO_SIDED|95.0|-2.7|14.1|||ANCOVA|||||14.1|-2.7|0.1787
91710389|NCT03597139|183313348|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.7666|TWO_SIDED|95.0|-12.6|9.3|||ANCOVA|||||9.3|-12.6|0.7666
91710390|NCT03597139|183313349|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.8082|TWO_SIDED|95.0|-10.7|8.4|||ANCOVA|||||8.4|-10.7|0.8082
91710391|NCT03597139|183313350|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.6362|TWO_SIDED|95.0|-37.0|60.3|||ANCOVA|||||60.3|-37|0.6362
91710392|NCT03597139|183313351|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.0961|TWO_SIDED|95.0|-1.7|20.9||Frequency|ANCOVA|||Frequency||20.9|-1.7|0.0961
91710393|NCT03597139|183313351|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.1722|TWO_SIDED|95.0|-3.4|18.7|||ANCOVA|||Severity||18.7|-3.4|0.1722
91710394|NCT03597139|183313352|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.0051|TWO_SIDED|95.0|1.6|8.9||Left Eye|ANCOVA|||Left Eye||8.9|1.6|0.0051
91710395|NCT03597139|183313352|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.0104|TWO_SIDED|95.0|1.1|8.4||Right Eye|ANCOVA|||Right Eye||8.4|1.1|0.0104
91789188|NCT01860846|183458514|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||< 0.001
91789189|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Physical Functioning Scores: the null hypothesis was set as no difference.||||< 0.001
91789190|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Physical Scores: the null hypothesis was set as no difference.||||< 0.001
91789191|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||=|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Emotional Scores: the null hypothesis was set as no difference.||||= 0.001
91789192|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||=|0.019||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Vitality Scores: the null hypothesis was set as no difference.||||= 0.019
91611299|NCT02940886|183116707|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0077|TWO_SIDED|95.0|1.27|4.72|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥2 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||4.72|1.27|0.0077
91611300|NCT02940886|183116707|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.8|3.26|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥2 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||3.26|1.80|<0.0001
91611301|NCT02940886|183116707|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1049|TWO_SIDED|95.0|0.96|1.58|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥2 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.58|0.96|0.1049
91611302|NCT02940886|183116707|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7032|TWO_SIDED|95.0|0.8|1.38|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥2 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.38|0.80|0.7032
91611303|NCT02940886|183116708|SUPERIORITY|||||||0.088|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0880
91611304|NCT02940886|183116709|SUPERIORITY||Odds Ratio (OR)|1.14||||0.242|TWO_SIDED|95.0|0.92|1.41|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.41|0.92|0.2420
91611305|NCT02940886|183116710|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8746|TWO_SIDED|95.0|0.81|1.28|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.28|0.81|0.8746
91611306|NCT02940886|183116711|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|3.58|5.71|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||5.71|3.58|<0.0001
91611307|NCT02940886|183116712|SUPERIORITY||Mean Difference (Final Values)|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.34|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.34|0.19|<0.0001
91611308|NCT02940886|183116712|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.19|0.38|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.38|0.19|<0.0001
91611309|NCT02940886|183116712|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.1091|TWO_SIDED|95.0|-0.02|0.2|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.20|-0.02|0.1091
91611310|NCT02940886|183116713|SUPERIORITY||Mean Difference (Final Values)|267.7|||<|0.0001|TWO_SIDED|95.0|246.3|289.0|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||289.0|246.3|<0.0001
91710396|NCT03597139|183313353|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.0003|TWO_SIDED|95.0|-3.2|-1.0||Left Eye|ANCOVA||Add in RE LE info|Left Eye||-1.0|-3.2|0.0003
91789193|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||=|0.017||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Mental Health Scores: the null hypothesis was set as no difference.||||= 0.017
91789194|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||=|0.007||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Functioning Scores: the null hypothesis was set as no difference.||||= 0.007
91789195|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bodily Pain Scores: the null hypothesis was set as no difference.||||< 0.001
91789196|NCT01860846|183458515|SUPERIORITY_OR_OTHER||||||=|0.005||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||General Health Scores: the null hypothesis was set as no difference.||||= 0.005
91789197|NCT01860846|183458516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bowel-related Symptoms Scores: The null hypothesis was set as no difference.||||< 0.001
91611311|NCT02940886|183116713|SUPERIORITY||Mean Difference (Final Values)|41.7|||<|0.0001|TWO_SIDED|95.0|25.6|57.8|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||57.8|25.6|<0.0001
91611312|NCT02940886|183116713|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.115|TWO_SIDED|95.0|-20.3|2.2|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.2|-20.3|0.1150
91611313|NCT02940886|183116713|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.0812|TWO_SIDED|95.0|-17.7|1.0|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.0|-17.7|0.0812
91611314|NCT02940886|183116714|SUPERIORITY||Mean Difference (Final Values)|11.4|||<|0.0001|TWO_SIDED|95.0|10.1|12.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||12.7|10.1|<0.0001
91611315|NCT02940886|183116714|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.0001|TWO_SIDED|95.0|1.2|3.6|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||3.6|1.2|0.0001
91611316|NCT02940886|183116714|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.0162|TWO_SIDED|95.0|0.2|2.1|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.1|0.2|0.0162
91611317|NCT02940886|183116714|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0569|TWO_SIDED|95.0|0.0|1.8|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.8|0.0|0.0569
91611318|NCT02940886|183116715|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|0.0001|TWO_SIDED|95.0|38.1|49.3|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||49.3|38.1|<0.0001
91654418|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.071||||0.5759|TWO_SIDED|95.0|-0.321|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.321|0.5759
91789198|NCT01860846|183458516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Systemic Symptoms Scores:The null hypothesis was set as no difference.||||< 0.001
91789199|NCT01860846|183458516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Emotional Function Scores: the null hypothesis was set as no difference.||||< 0.001
91789200|NCT01860846|183458516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Function Scores: The null hypothesis was set as no difference.||||< 0.001
91789201|NCT00770146|183458526|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.||||<0.001
91611319|NCT02940886|183116715|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0375|TWO_SIDED|95.0|0.3|9.8|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||9.8|0.3|0.0375
91611320|NCT02940886|183116715|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.6027|TWO_SIDED|95.0|-4.0|2.3|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.3|-4.0|0.6027
91611321|NCT02940886|183116715|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8207|TWO_SIDED|95.0|-2.7|3.4|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||3.4|-2.7|0.8207
91611322|NCT02940886|183116716|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.0422|TWO_SIDED|95.0|0.04|2.01|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||2.01|0.04|0.0422
91611323|NCT02940886|183116716|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4646|TWO_SIDED|95.0|-1.44|0.66|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.66|-1.44|0.4646
91611324|NCT02940886|183116716|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.5703|TWO_SIDED|95.0|-1.39|0.76|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.76|-1.39|0.5703
91611325|NCT00474630|183116730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.28|||<|0.001||95.0|-4.34|-2.22|||ANCOVA|||||-2.22|-4.34|<0.001
91611326|NCT00474630|183116731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|||||-0.27|-0.71|<0.001
91611327|NCT00474630|183116732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.15|5.5|||Regression, Logistic|||||5.50|2.15|<0.001
91611328|NCT00474630|183116733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
91611329|NCT00474630|183116734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.32|||<|0.001|TWO_SIDED|95.0|1.8|4.84|||ANCOVA|||||4.84|1.80|<0.001
91611330|NCT00474630|183116735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.85||||0.065|TWO_SIDED|95.0|-16.21|0.5|||ANCOVA|||||0.50|-16.21|0.065
91611331|NCT00474630|183116736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.57|-0.59||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.59|-3.57|
91611332|NCT00474630|183116737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75|||||TWO_SIDED|95.0|1.79|7.88||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.88|1.79|
91611333|NCT00474630|183116738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||||TWO_SIDED|95.0|1.5|4.04||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.04|1.50|
91789202|NCT00770146|183458528|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
91789203|NCT00770146|183458530|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91611334|NCT00474630|183116739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.35|0.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.86|0.35|
91611335|NCT00474630|183116740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.27|7.57||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.57|0.27|
91611336|NCT00474630|183116741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|0.55|12.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||12.67|0.55|
91710397|NCT03597139|183313353|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0038|TWO_SIDED|95.0|-2.6|-0.5||Right Eye|ANCOVA|||Right Eye||-0.5|-2.6|0.0038
91611337|NCT00474630|183116742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.89|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
91789204|NCT00770146|183458532|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
91789205|NCT00770146|183458534|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
91789206|NCT00770146|183458536|SUPERIORITY_OR_OTHER|||||||0.977||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.977
91789207|NCT00770146|183458538|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
91789208|NCT00770146|183458540|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
91789209|NCT00770146|183458542|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
91789210|NCT00770146|183458544|SUPERIORITY_OR_OTHER|||||||0.032||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.032
91789211|NCT04345367|183458564|SUPERIORITY||Estimate of difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.8|29.5||Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.5|15.8|<0.0001
91789212|NCT04345367|183458565|SUPERIORITY||Estimate of difference|14.1|||<|0.0001|TWO_SIDED|95.0|8.2|20.0||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|8.2|<0.0001
91789213|NCT04345367|183458566|SUPERIORITY||Estimate of difference|12.5||||0.0008|TWO_SIDED|95.0|5.3|19.7||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.7|5.3|0.0008
91789214|NCT04345367|183458567|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|0.2|8.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||8.7|0.2|
91789215|NCT04345367|183458567|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.2|26.9|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|13.2|
91789216|NCT04345367|183458567|OTHER||Estimate of difference|14.0|||||TWO_SIDED|95.0|6.9|21.1|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.1|6.9|
91789217|NCT04345367|183458567|OTHER||Estimate of difference|12.7|||||TWO_SIDED|95.0|5.5|20.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|5.5|
91789218|NCT04345367|183458567|OTHER||Estimate of difference|6.9|||||TWO_SIDED|95.0|-0.4|14.3|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.3|-0.4|
91611338|NCT00474630|183116743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.13|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
91611339|NCT00474630|183116744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.36|5.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||5.14|1.36|
91611340|NCT00474630|183116745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|-0.77|3.51||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.51|-0.77|
91611341|NCT00474630|183116746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.62|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
91611342|NCT00474630|183116748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.98|||||TWO_SIDED|95.0|-9.22|-0.74||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.74|-9.22|
91611343|NCT00474630|183116749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.43|||||TWO_SIDED|95.0|-7.48|4.62||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.62|-7.48|
91611344|NCT00474630|183116750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|-1.02|3.33||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.33|-1.02|
91611345|NCT00474630|183116751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.04|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-1.04|
91611346|NCT00474630|183116752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|0.59|2.65||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.65|0.59|
91611347|NCT00474630|183116753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43|||||TWO_SIDED|95.0|-0.42|1.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.27|-0.42|
91611348|NCT00474630|183116754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|96.0|-0.76|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-0.76|
91611349|NCT00591227|183116771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 1 sided|||||||0.58
91611350|NCT01873742|183116789|OTHER|The BDI's Cronbach's alpha was .93 at start of therapy, and .95 at the end of therapy.|Mean Difference (Final Values)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91611351|NCT00942708|183116805|OTHER|Single group evaluation of change in PVR between 12 weeks and baseline (T-test for one group, 2-sided, p\<0.05 considered significant)||||||0.09|||||||t-test, 1 sided|||||||0.09
91611352|NCT00995371|183116892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52|||<|0.05|TWO_SIDED|95.0|1.09|3.96|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.96|1.09|<0.05
91611353|NCT00995371|183116892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||>|0.05|TWO_SIDED|95.0|-1.43|1.55|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||1.55|-1.43|>0.05
91611354|NCT00995371|183116893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.33|||<|0.05|TWO_SIDED|95.0|3.35|19.31|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||19.31|3.35|<0.05
91611355|NCT00995371|183116893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.65|||>|0.05||95.0|-4.12|15.41|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||15.41|-4.12|>0.05
91611356|NCT00995371|183116894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.05||95.0|0.61|3.77|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.77|0.61|<0.05
91611357|NCT00995371|183116894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||>|0.05||95.0|-0.66|2.66|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||2.66|-0.66|>0.05
91611358|NCT00995371|183116895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.13|||<|0.05||95.0|7.43|24.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||24.83|7.43|<0.05
91710398|NCT01249833|183313354|SUPERIORITY_OR_OTHER||LS Means Difference|-30.4||||0.0492|TWO_SIDED|95.0|-60.7|-0.1|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||-0.1|-60.7|.0492
91611359|NCT00995371|183116895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.17|||>|0.05||95.0|-1.24|13.58|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||13.58|-1.24|>0.05
91611360|NCT01462292|183116899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.946||||0.554|TWO_SIDED|95.0|-39.122|21.229||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilizing a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg||21.229|-39.122|0.554
91611361|NCT01462292|183116899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.099||||0.069|TWO_SIDED|95.0|-2.21|56.408||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilising a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg||56.408|-2.210|0.069
91611362|NCT01462292|183116900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.387||||0.699|TWO_SIDED|95.0|-1.618|2.392||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||2.392|-1.618|0.699
91611363|NCT01462292|183116900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.831||||0.384|TWO_SIDED|95.0|-1.072|2.735||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.735|-1.072|0.384
91611364|NCT01462292|183116901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.997|TWO_SIDED|95.0|-0.883|0.886||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment,centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Ascent Week 24||0.886|-0.883|0.997
91611365|NCT01462292|183116901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.803||||0.064|TWO_SIDED|95.0|-1.655|0.048||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Ascent, Week 24||0.048|-1.655|0.064
91611366|NCT01462292|183116901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.685||||0.311|TWO_SIDED|95.0|-2.033|0.662||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Descent Week 24||0.662|-2.033|0.311
91710399|NCT01249833|183313355|SUPERIORITY_OR_OTHER||LS Means Difference|3.8||||0.0054|TWO_SIDED|95.0|1.14|6.42|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||6.42|1.14|0.0054
91710400|NCT01249833|183313356|SUPERIORITY_OR_OTHER||LS Means Difference|3.9||||0.9685|TWO_SIDED|95.0|-190.1|197.9|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||197.9|-190.1|.9685
91710401|NCT01249833|183313357|SUPERIORITY_OR_OTHER||LS Means Difference|1.9||||0.3195|TWO_SIDED|95.0|-1.9|5.7|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|Alertness: the higher the value, the greater the alertness.||5.7|-1.9|.3195
91710402|NCT01249833|183313357|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.7219|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA||The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.|Calmness: the higher the value, the greater the calmness.||2.9|-4.1|.7219
91789219|NCT04345367|183458568|OTHER||Estimate of difference|8.1|||||TWO_SIDED|95.0|1.8|14.4|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.4|1.8|
91789220|NCT04345367|183458568|OTHER||Estimate of difference|20.9|||||TWO_SIDED|95.0|13.8|28.0|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.0|13.8|
91710403|NCT01249833|183313357|SUPERIORITY_OR_OTHER||LS Means Difference|3.3||||0.1162|TWO_SIDED|95.0|-0.8|7.4|||ANCOVA||The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.|Contentedness: the higher the value, the greater the contentedness.||7.4|-.8|.1162
91789221|NCT04345367|183458568|OTHER||Estimate of difference|18.4|||||TWO_SIDED|95.0|11.4|25.3|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||25.3|11.4|
91611367|NCT01462292|183116901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.412||||0.523|TWO_SIDED|95.0|-1.702|0.878||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Descent Week 24||0.878|-1.702|0.523
91611368|NCT01462292|183116902|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.564||||0.05|TWO_SIDED|95.0|0.0|1.127||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.127|0.000|0.050
91611369|NCT01462292|183116902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.89|TWO_SIDED|95.0|-0.498|0.571||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||0.571|-0.498|0.890
91611370|NCT01462292|183116903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.356||||0.723|TWO_SIDED|95.0|-10.936|15.648||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 3 mg||15.648|-10.936|0.723
91611371|NCT01462292|183116903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821||||0.898|TWO_SIDED|95.0|-12.034|13.676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 6mg||13.676|-12.034|0.898
91611372|NCT01462292|183116905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.684|TWO_SIDED|95.0|-2.9|1.92||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.92|-2.90|0.684
91611373|NCT01462292|183116905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.873|TWO_SIDED|95.0|-2.49|2.12||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.12|-2.49|0.873
91611374|NCT01462292|183116907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-892.88||||0.61|TWO_SIDED|95.0|-4391.1|2605.35||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 24||2605.35|-4391.10|0.610
91611375|NCT01462292|183116907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2054.86||||0.248|TWO_SIDED|95.0|-5587.33|1477.6||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 48||1477.60|-5587.33|0.248
91611376|NCT01462292|183116907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1305.46||||0.439|TWO_SIDED|95.0|-4668.41|2057.48||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 24||2057.48|-4668.41|0.439
91611377|NCT01462292|183116907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|167.39||||0.921|TWO_SIDED|95.0|-3208.98|3543.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 48||3543.77|-3208.98|0.921
91611378|NCT01462292|183116914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.541|TWO_SIDED|95.0|0.02|7.01||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 3 mg/kg/week||7.01|0.02|0.541
91611379|NCT01462292|183116914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.417|TWO_SIDED|95.0|0.03|4.27||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 6 mg/kg/week||4.27|0.03|0.417
91611380|NCT02613572|183116927|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91611381|NCT02613572|183116928|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
91611382|NCT02613572|183116929|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91611383|NCT02613572|183116930|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
91611384|NCT02613572|183116931|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||||||0.14
91611385|NCT02613572|183116932|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|||||||0.69
91611386|NCT02342561|183116933|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||At end of surgery||||0.601
91611387|NCT02342561|183116933|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||After skin disinfection||||0.823
91611388|NCT02342561|183116934|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Fisher Exact|||Difference in prevalence of CoNs between the 2 groups was analysed. The null-hypothesis was no difference.||||0.731
91611389|NCT01282814|183116978|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|115.85|||||TWO_SIDED|90.0|108.45|123.72|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.72|108.45|
91611390|NCT01282814|183116979|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.97|||||TWO_SIDED|90.0|103.68|116.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.63|103.68|
91611391|NCT01282814|183116980|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.46|||||TWO_SIDED|90.0|101.45|111.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.71|101.45|
91611392|NCT01524289|183116981|SUPERIORITY||Difference in Least Squares (LS) Means|-39.7|||<|0.001|TWO_SIDED|95.0|-45.7|-33.7|||Constrained Longitudinal Data Analysis|Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model.||||-33.7|-45.7|<0.001
91611393|NCT01524289|183116982|OTHER|Pre-specified|Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-11.5|8.4|||||||Miettinen and Nurminen|8.4|-11.5|
91611394|NCT01524289|183116983|OTHER|Pre-specified|Difference in Percentages|4.5|||||TWO_SIDED|95.0|-4.8|12.6|||||||Miettinen and Nurminen|12.6|-4.8|
91611395|NCT01524289|183116984|OTHER|Pre-specified|Difference in Percentages|-0.9|||||TWO_SIDED|95.0|-8.9|5.6|||||||Miettinen \& Nurminen|5.6|-8.9|
91611396|NCT01524289|183116985|OTHER|Pre-specified|Difference in Percentages|1.0|||||TWO_SIDED|95.0|-5.5|6.1|||||||Miettinen and Nurminen|6.1|-5.5|
91611397|NCT01524289|183116986|OTHER|Pre-Specified|Difference in Percentages|-8.4||||0.168|TWO_SIDED|95.0|-20.1|3.5|||Miettinen and Nurminen|||||3.5|-20.1|0.168
91611398|NCT01524289|183116987|OTHER|Pre-specified|Difference in Percentages|-7.4||||0.179|TWO_SIDED|95.0|-18.7|3.3|||Miettinen and Nurminen|||||3.3|-18.7|0.179
91611399|NCT01524289|183116988|OTHER|Pre-specified|Difference in Percentages|-13.9||||0.011|TWO_SIDED|95.0|-25.0|-3.1|||Miettinen and Nurminen|||||-3.1|-25.0|0.011
91654419|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.285||||0.0271|TWO_SIDED|95.0|-0.538|-0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.033|-0.538|0.0271
91654420|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.14||||0.2804|TWO_SIDED|95.0|-0.395|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.115|-0.395|0.2804
91654421|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.218||||0.0913|TWO_SIDED|95.0|-0.472|0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.035|-0.472|0.0913
91611400|NCT01524289|183116989|OTHER|Pre-specified|Difference in Percentages|1.5||||0.696|TWO_SIDED|95.0|-6.8|8.4|||Miettinen and Nurminen|||||8.4|-6.8|0.696
91611401|NCT01524289|183116990|OTHER|Pre-specified|Difference in Percentages|0.5||||0.48|TWO_SIDED|95.0|-3.2|2.8|||Miettinen and Nurminen|||||2.8|-3.2|0.480
91611402|NCT01524289|183116991|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
91611403|NCT01524289|183116992|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|1.9|||Miettinen and Nurminen|||||1.9|-3.7|>0.999
91611404|NCT01524289|183116993|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
91611405|NCT01524289|183116994|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
91611406|NCT01524289|183116995|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
91654422|NCT02637557|183201458|SUPERIORITY||LS Mean Difference|-0.38||||0.0039|TWO_SIDED|95.0|-0.637|-0.123||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.123|-0.637|0.0039
91611407|NCT01524289|183116996|OTHER|Pre-specified|Difference in Percentages|1.5||||0.218|TWO_SIDED|95.0|-2.2|4.3|||Miettinen and Nurminen|||||4.3|-2.2|0.218
91611408|NCT01524289|183116997|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.6|1.9|||Miettinen and Nurminen|||||1.9|-3.6|>0.999
91611409|NCT01524289|183116998|SUPERIORITY||Difference in Least Squares (LS) Means|102.1|||<|0.001|TWO_SIDED|95.0|94.2|110.1|||Constrained Longitudinal Data Analysis|||||110.1|94.2|<0.001
91611410|NCT01524289|183116999|SUPERIORITY||Difference in LS Means|-36.4|||<|0.001|TWO_SIDED|95.0|-41.7|-31.1|||Constrained Longitudinal Data Analysis|||||-31.1|-41.7|<0.001
91611411|NCT01524289|183117000|SUPERIORITY||Difference in LS Means|-24.8|||<|0.001|TWO_SIDED|95.0|-29.5|-20.1|||Constrained Longitudinal Data Analysis|||||-20.1|-29.5|<0.001
91611412|NCT01524289|183117001|SUPERIORITY||Difference in LS Means|32.9|||<|0.001|TWO_SIDED|95.0|28.2|37.6|||Constrained Longitudinal Data Analysis|||||37.6|28.2|<0.001
91611413|NCT01524289|183117002|SUPERIORITY||Median Difference (Final Values)|-27.9|||<|0.001|TWO_SIDED|95.0|-34.7|-21.2|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test.|||-21.2|-34.7|<0.001
91654423|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|0.128||||0.1902|TWO_SIDED|95.0|-0.064|0.319||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.319|-0.064|0.1902
91654424|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|0.1||||0.3021|TWO_SIDED|95.0|-0.091|0.292||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.292|-0.091|0.3021
91654425|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.028||||0.775|TWO_SIDED|95.0|-0.221|0.165||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.165|-0.221|0.7750
91710404|NCT00802672|183313377|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary efficacy analysis, a 90% confidence interval was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)|Mean Difference (Final Values)|1.0|||||TWO_SIDED|90.0|-17.61|2.45|||Wald's method with Yates' continuity|||||2.45|-17.61|
91710405|NCT03159299|183313397|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.15|TWO_SIDED||||||Mixed Models Analysis|||||||<0.15
91789222|NCT04345367|183458568|OTHER||Estimate of difference|14.9|||||TWO_SIDED|95.0|8.2|21.5|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.5|8.2|
91611414|NCT02519231|183117020|SUPERIORITY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|5.0||0.11|TWO_SIDED|95.0||||The threshold for statistical significance was p =0.05|t-test, 2 sided|For days with bleeding/spotting outcomes, we used independent t-tests to compare the unadjusted mean difference between groups.|Treatment Difference = Naproxen - Placebo|We originally planned to enroll 60 subjects based on other similar studies that evaluated treatment for bleeding among women using contraception; as reported by Cohen et al., a sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t-test, allowing for an expected 20% drop-out.|We designed the study to include another site, in addition to the UW site enrolled participants. After 6 months of failed active recruitment at the other site, we discontinued that site from the study. Resources did not permit us to contract with an alternative recruitment site, and thus the protocol was revised to enroll 32 participants at the Seattle site only.|||.11
91611415|NCT02519231|183117021|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91611416|NCT01707147|183117044|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_DEVIATION|1.5|<|0.0001|TWO_SIDED|95.0|-0.83|-0.71|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-0.71|-0.83|<0.0001
91611417|NCT01707147|183117047|OTHER||Mean Difference (Final Values)|-18.05|STANDARD_DEVIATION|61.84|<|0.0001|TWO_SIDED|95.0|-20.98|-15.12|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-15.12|-20.98|<0.0001
91611418|NCT01592851|183117111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.63||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.63|-1.03|<0.0001
91611419|NCT01592851|183117112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26||||0.0006|TWO_SIDED|95.0|-0.41|-0.12||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.12|-0.41|0.0006
91611420|NCT01592851|183117113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.28||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.28|-0.63|<0.0001
91611421|NCT01592851|183117114|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|19.42|||<|0.0001|TWO_SIDED|95.0|13.7|25.15||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||25.15|13.70|<0.0001
91611422|NCT01592851|183117115|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.84||||0.0021|TWO_SIDED|95.0|2.54|11.13||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||11.13|2.54|0.0021
91611423|NCT01592851|183117116|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|3.87||||0.007|TWO_SIDED|95.0|1.08|6.65||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||6.65|1.08|0.0070
91710406|NCT01990573|183313425|OTHER|ANOVA|F statistic|0.002||||0.002|TWO_SIDED||||||ANOVA|||||||.002
91710407|NCT01990573|183313426|OTHER|ANOVA|F statistic|0.962||||0.962|TWO_SIDED||||||ANOVA|||||||.962
91710408|NCT00320242|183313487|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.48||0.0152|TWO_SIDED|95.0|0.26|2.23|||t-test, 2 sided|two-tailed paired t-test||||2.23|0.26|0.0152
91710409|NCT00320242|183313488|SUPERIORITY||Mean Difference (Final Values)|50.0|STANDARD_ERROR_OF_MEAN|11.7||0.005|TWO_SIDED|95.0|23.9|76.1|||t-test, 2 sided|||||76.1|23.9|0.005
91789223|NCT04345367|183458568|OTHER||Estimate of difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.0|3.0|
91789224|NCT04345367|183458568|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.4|11.5|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.5|-1.4|
91789225|NCT04345367|183458568|OTHER||Estimate of difference|0.7|||||TWO_SIDED|95.0|-5.9|7.2|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||7.2|-5.9|
91611424|NCT00663858|183117117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.592|STANDARD_ERROR_OF_MEAN|0.662||0.371|TWO_SIDED|95.0|-1.894|0.709|||ANOVA|||||0.709|-1.894|0.371
91611425|NCT00663858|183117117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.711|STANDARD_ERROR_OF_MEAN|0.722||0.3253|TWO_SIDED|95.0|-709.0|2.132|||ANCOVA|||||2.132|-0709|0.3253
91611426|NCT00663858|183117117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.324|STANDARD_ERROR_OF_MEAN|0.62||0.0333|TWO_SIDED|95.0|-2.542|-0.106|||ANCOVA|||||-0.106|-2.542|0.0333
91611427|NCT01666444|183117141|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.22||||0.923|ONE_SIDED|92.0||1.48||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).|Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.|The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.||1.48||0.923
91611428|NCT01666444|183117142|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21||||0.943|ONE_SIDED|98.0||1.56||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).||The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.||1.56||0.943
91611429|NCT05099991|183117236|NON_INFERIORITY|Non-inferiority would be demonstrated with a mean increase in procedure of 5 minutes.|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.8|8.2||||||||8.2|-7.8|
91611430|NCT05099991|183117237|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
91611431|NCT01954628|183117238|SUPERIORITY_OR_OTHER||Least sqaure mean difference|23.7||||0.759|TWO_SIDED|95.0|-128.3|175.7||AAC were compared between treatments using an analysis of variance model adjusting for treatment and region as factors and including the baseline score as a covariate.|ANOVA|||Sample size based on area above the daily EXACT score curve (AAC) from Day 1 to Day 29 from subjects with an acute COPD exacerbation, collected over 28 days. Assuming a residual SD of 500 points, a sample size of 200 subjects per arm would be expected to have an 80% power to detect a true treatment difference in the AAC of 140 points over 12-weeks treatment, using a 2-sided test; alpha-level of 0.05.This difference corresponds to a mean daily improvement of 1.67 points on the EXACT symptom score||175.7|-128.3|0.759
91611432|NCT01954628|183117239|SUPERIORITY_OR_OTHER||Least sqaure mean difference|-0.34||||0.588|TWO_SIDED|95.0|-1.57|0.89|||ANOVA|||ANOVA model with fixed factors treatment, region and baseline total CAT score as covariate were used. Missing post-treatment data were imputed using the Last Observation Carried Forward principle.||0.89|-1.57|0.588
91611433|NCT01954628|183117240|SUPERIORITY_OR_OTHER||Least sqaure mean difference|1.083||||0.646|TWO_SIDED|95.0|0.771|1.52|||Negative binomial regression model|Negative binomial regression model with fixed factors treatment, region and time in study as offset.||The number of subjects with at least one COPD exacerbation were summarised by treatment group.||1.520|0.771|0.646
91611434|NCT01954628|183117243|SUPERIORITY_OR_OTHER|||||||0.226|||||||ANOVA|||Missing post-treatment data was imputed using the Last Observation Carried Forward principle.||||0.226
91611435|NCT00958568|183117245|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.||||<0.001
91611436|NCT00958568|183117246|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
91611437|NCT00958568|183117247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
91611438|NCT00958568|183117248|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.713
91611439|NCT00958568|183117249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
91611440|NCT00958568|183117250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
91611441|NCT00958568|183117251|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||0.831
91611442|NCT00958568|183117252|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
91611443|NCT00958568|183117256|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.047
91611444|NCT00958568|183117257|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.46|-1.36||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.36|-4.46|<0.001
91789226|NCT04345367|183458569|OTHER||Estimate of difference|7.3|||||TWO_SIDED|95.0|2.8|11.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.7|2.8|
91611445|NCT00958568|183117258|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82|||<|0.001|TWO_SIDED|95.0|-5.39|-2.24||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-2.24|-5.39|<0.001
91611446|NCT00958568|183117259|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|-0.55|-0.12||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-0.12|-0.55|0.002
91611447|NCT00958568|183117262|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.72||0.007|TWO_SIDED|95.0|-3.36|-0.53||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-0.53|-3.36|0.007
91611448|NCT00958568|183117263|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
91611449|NCT00958568|183117264|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.248
91611450|NCT00958568|183117265|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
91611451|NCT00958568|183117266|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|4.47||0.839|TWO_SIDED|95.0|-9.71|7.89||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||7.89|-9.71|0.839
91611452|NCT00958568|183117267|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.352
91611453|NCT00958568|183117267|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
91611454|NCT00958568|183117267|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
91710410|NCT00320242|183313489|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_DEVIATION|1.31||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-tailed Wilcoxan signed-rank sum test||two-tailed Wilcoxan signed-rank sum test||||0.02
91789227|NCT04345367|183458569|OTHER||Estimate of difference|20.6|||||TWO_SIDED|95.0|14.3|26.9|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|14.3|
91523862|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Hypoglycemic episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
91789228|NCT04345367|183458569|OTHER||Estimate of difference|19.5|||||TWO_SIDED|95.0|12.5|26.4|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.4|12.5|
91789229|NCT04345367|183458569|OTHER||Estimate of difference|15.8|||||TWO_SIDED|95.0|8.7|23.0|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||23.0|8.7|
91789230|NCT04345367|183458569|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|5.9|20.2|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.2|5.9|
91611455|NCT00958568|183117268|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|4.12||0.703|TWO_SIDED|95.0|-9.69|6.54||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||6.54|-9.69|0.703
91611456|NCT00958568|183117269|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.139
91789231|NCT04345367|183458569|OTHER||Estimate of difference|9.2|||||TWO_SIDED|95.0|2.0|16.4|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.4|2.0|
91789232|NCT04345367|183458569|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|-2.8|11.8|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.8|-2.8|
91789233|NCT04345367|183458570|OTHER||Estimate of difference|7.1|||||TWO_SIDED|95.0|3.1|11.1|||||Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.1|3.1|
91611457|NCT00958568|183117269|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.746
91654426|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|0.099||||0.4022|TWO_SIDED|95.0|-0.133|0.33||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.330|-0.133|0.4022
91789234|NCT04345367|183458570|OTHER||Estimate of difference|6.5|||||TWO_SIDED|95.0|1.7|11.3|||||Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.3|1.7|
91789235|NCT04345367|183458570|OTHER||Estimate of difference|11.4|||||TWO_SIDED|95.0|6.0|16.8|||||Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.8|6.0|
91789236|NCT04345367|183458570|OTHER||Estimate of difference|14.5|||||TWO_SIDED|95.0|8.8|20.3|||||Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.3|8.8|
91789237|NCT04345367|183458570|OTHER||Estimate of difference|12.9|||||TWO_SIDED|95.0|6.9|19.0|||||Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.0|6.9|
91789238|NCT04345367|183458570|OTHER||Estimate of difference|19.9|||||TWO_SIDED|95.0|13.8|26.0|||||Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.0|13.8|
91523863|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.730
91611458|NCT00958568|183117269|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.458
91654427|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|0.062||||0.5971|TWO_SIDED|95.0|-0.169|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.293|-0.169|0.5971
91789239|NCT04345367|183458570|OTHER||Estimate of difference|22.1|||||TWO_SIDED|95.0|15.9|28.3|||||Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.3|15.9|
91789240|NCT04345367|183458570|OTHER||Estimate of difference|21.7|||||TWO_SIDED|95.0|15.2|28.1|||||Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.1|15.2|
91789241|NCT04345367|183458570|OTHER||Estimate of other|21.3|||||TWO_SIDED|95.0|14.7|27.9|||||Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.7|
91789242|NCT04345367|183458570|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.3|26.6|||||Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.6|13.3|
91611459|NCT00958568|183117270|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73|STANDARD_ERROR_OF_MEAN|1.15||0.001|TWO_SIDED|95.0|-5.99|-1.47||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.47|-5.99|0.001
91611460|NCT00958568|183117271|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.004
91611461|NCT00958568|183117272|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
91611462|NCT00958568|183117273|SUPERIORITY_OR_OTHER||LS Mean Difference|13.27|STANDARD_ERROR_OF_MEAN|7.62||0.083|TWO_SIDED|95.0|-1.72|28.26||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||28.26|-1.72|0.083
91654428|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.045||||0.7024|TWO_SIDED|95.0|-0.279|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.188|-0.279|0.7024
91654429|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.115||||0.3173|TWO_SIDED|95.0|-0.342|0.111||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.111|-0.342|0.3173
91654430|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.151||||0.1906|TWO_SIDED|95.0|-0.378|0.076||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.076|-0.378|0.1906
91611463|NCT00958568|183117274|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.029
91611464|NCT00958568|183117274|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.014
91611465|NCT00958568|183117274|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.054
91611466|NCT00958568|183117275|SUPERIORITY_OR_OTHER||LS Mean Difference|5.89|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|2.22|9.56||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||9.56|2.22|0.002
91611467|NCT00958568|183117276|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.031
91611468|NCT00958568|183117276|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
91710411|NCT00320242|183313490|OTHER|The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||||0.002||||||Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.|t-test, 2 sided|||The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||0.002
91789243|NCT04345367|183458570|OTHER||Estimate of difference|21.3|||||TWO_SIDED|95.0|14.6|27.9|||||Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.6|
91789244|NCT04345367|183458570|OTHER||Estimate of difference|22.5|||||TWO_SIDED|95.0|15.8|29.2|||||Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.8|
91611469|NCT00958568|183117276|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.344
91611470|NCT00958568|183117276|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.072
91611471|NCT00958568|183117277|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|2.96|4.88||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||4.88|2.96|<0.001
91611472|NCT00958568|183117278|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was 0.05.|Fisher Exact|||||||<0.001
91611473|NCT00958568|183117279|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.392
91611474|NCT00958568|183117280|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.95||0.421|TWO_SIDED|95.0|-5.42|2.27||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||2.27|-5.42|0.421
91611475|NCT00117338|183117306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.775||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.775
91654431|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.183||||0.1177|TWO_SIDED|95.0|-0.412|0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.046|-0.412|0.1177
91654432|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.05||||0.6936|TWO_SIDED|95.0|-0.297|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.297|0.6936
91710412|NCT00411450|183313492|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Difference = Wild type - Mutant|Difference at Week 17||21|-11|
91710413|NCT00411450|183313492|SUPERIORITY_OR_OTHER||Difference|8.0|||||TWO_SIDED|95.0|-9.0|23.0||||||Difference at Week 25||23|-9|
91789245|NCT04345367|183458570|OTHER||Estimate of difference|22.4|||||TWO_SIDED|95.0|15.6|29.2|||||Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.6|
91789246|NCT04345367|183458570|OTHER||Estimate of difference|22.9|||||TWO_SIDED|95.0|16.0|29.9|||||Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.9|16.0|
91789247|NCT04345367|183458571|OTHER||Estimate of difference|17.3|||||TWO_SIDED|95.0|10.1|24.5|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||24.5|10.1|
91789248|NCT04345367|183458571|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|6.0|20.1|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|6.0|
91611476|NCT00117338|183117307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.931||95.0|-0.41|0.45|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.45|-0.41|0.931
91611477|NCT00117338|183117308|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.975||95.0|0.61|1.61|||Regression, Logistic|Model terms: treatment and baseline FEV1 as covariate||||1.61|0.61|0.975
91611478|NCT00117338|183117309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.612||95.0|-0.05|0.09|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.09|-0.05|0.612
91611479|NCT00117338|183117310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.774
91611480|NCT00117338|183117311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.173||95.0|-0.02|0.11|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.11|-0.02|0.173
91611481|NCT00117338|183117312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||ANCOVA|ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate||||||0.580
91611482|NCT01380093|183117313|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-31.7|-18.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.1|-31.7|<0.0001
91611483|NCT01380093|183117313|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0009|TWO_SIDED|95.0|5.1|18.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.6|5.1|0.0009
91611484|NCT01380093|183117313|SUPERIORITY_OR_OTHER||LS Mean Difference|36.8|||<|0.0001|TWO_SIDED|95.0|30.0|43.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||43.6|30.0|<0.0001
91611485|NCT01380093|183117314|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.7|||<|0.0001|TWO_SIDED|95.0|-20.2|-11.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.||-11.1|-20.2|<0.0001
91611486|NCT01380093|183117314|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.9|18.0||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.0|8.9|<0.0001
91611487|NCT01380093|183117314|SUPERIORITY_OR_OTHER||LS Mean Difference|29.1|||<|0.0001|TWO_SIDED|95.0|24.6|33.7||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.7|24.6|<0.0001
91611488|NCT01380093|183117315|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.1|||<|0.0001|TWO_SIDED|95.0|-61.2|-41.0||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-41.0|-61.2|<0.0001
91654433|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.096||||0.4466|TWO_SIDED|95.0|-0.343|0.152||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.152|-0.343|0.4466
91611489|NCT01380093|183117315|SUPERIORITY_OR_OTHER||LS Mean Difference|24.6|||<|0.0001|TWO_SIDED|95.0|14.5|34.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.6|14.5|<0.0001
91611490|NCT01380093|183117315|SUPERIORITY_OR_OTHER||LS Mean Difference|75.7|||<|0.0001|TWO_SIDED|95.0|65.6|85.8||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||85.8|65.6|<0.0001
91611491|NCT01380093|183117316|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.9|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-11.8|<0.0001
91611492|NCT01380093|183117316|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0006|TWO_SIDED|95.0|2.3|8.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.1|2.3|0.0006
91654434|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.155||||0.2225|TWO_SIDED|95.0|-0.405|0.095||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.095|-0.405|0.2225
91611493|NCT01380093|183117316|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1|||<|0.0001|TWO_SIDED|95.0|11.2|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.0|11.2|<0.0001
91611494|NCT01380093|183117317|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-62.0|-35.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.5|-62.0|<0.0001
91611495|NCT01380093|183117317|SUPERIORITY_OR_OTHER||LS Mean Difference|29.0|||<|0.0001|TWO_SIDED|95.0|15.8|42.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.3|15.8|<0.0001
91611496|NCT01380093|183117317|SUPERIORITY_OR_OTHER||LS Mean Difference|77.8|||<|0.0001|TWO_SIDED|95.0|64.5|91.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||91.0|64.5|<0.0001
91611497|NCT01380093|183117318|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.6|||<|0.0001|TWO_SIDED|95.0|-95.0|-42.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-42.2|-95.0|<0.0001
91611498|NCT01380093|183117318|SUPERIORITY_OR_OTHER||LS Mean Difference|56.5|||<|0.0001|TWO_SIDED|95.0|30.1|82.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||82.8|30.1|<0.0001
91611499|NCT01380093|183117318|SUPERIORITY_OR_OTHER||LS Mean Difference|125.1|||<|0.0001|TWO_SIDED|95.0|98.7|151.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||151.5|98.7|<0.0001
91611500|NCT01380093|183117319|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.0||||0.0001|TWO_SIDED|95.0|-112.8|-39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-39.2|-112.8|0.0001
91611501|NCT01380093|183117319|SUPERIORITY_OR_OTHER||LS Mean Difference|66.5||||0.0006|TWO_SIDED|95.0|29.8|103.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||103.2|29.8|0.0006
91611502|NCT01380093|183117319|SUPERIORITY_OR_OTHER||LS Mean Difference|142.5|||<|0.0001|TWO_SIDED|95.0|105.7|179.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||179.3|105.7|<0.0001
91611503|NCT01380093|183117320|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.2||||0.0011|TWO_SIDED|95.0|-136.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-136.5|0.0011
91611504|NCT01380093|183117320|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8||||0.0071|TWO_SIDED|95.0|19.7|120.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||120.0|19.7|0.0071
91611505|NCT01380093|183117320|SUPERIORITY_OR_OTHER||LS Mean Difference|156.0|||<|0.0001|TWO_SIDED|95.0|105.7|206.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||206.3|105.7|<0.0001
91611506|NCT01380093|183117321|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.1254|TWO_SIDED|95.0|-0.6|4.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.7|-0.6|0.1254
91611507|NCT01380093|183117321|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.4592|TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.6|-3.6|0.4592
91611508|NCT01380093|183117321|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0||||0.0251|TWO_SIDED|95.0|-5.6|-0.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.4|-5.6|0.0251
91710414|NCT00411450|183313494|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-11.0|23.0|||||Difference = Wild type - Mutant|||23|-11|
91611509|NCT01380093|183117322|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.9|-11.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.0|-19.9|<0.0001
91611510|NCT01380093|183117322|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|4.8|13.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.7|4.8|<0.0001
91611511|NCT01380093|183117322|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|||<|0.0001|TWO_SIDED|95.0|20.3|29.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||29.1|20.3|<0.0001
91611512|NCT01380093|183117323|SUPERIORITY_OR_OTHER||LS Mean Difference|-116.1|||<|0.0001|TWO_SIDED|95.0|-136.5|-95.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-95.7|-136.5|<0.0001
91611513|NCT01380093|183117323|SUPERIORITY_OR_OTHER||LS Mean Difference|59.7|||<|0.0001|TWO_SIDED|95.0|39.3|80.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.1|39.3|<0.0001
91611514|NCT01380093|183117323|SUPERIORITY_OR_OTHER||LS Mean Difference|175.8|||<|0.0001|TWO_SIDED|95.0|155.4|196.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||196.2|155.4|<0.0001
91611515|NCT01380093|183117324|SUPERIORITY_OR_OTHER||LS Mean Difference|-202.2|||<|0.0001|TWO_SIDED|95.0|-239.0|-165.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-165.3|-239.0|<0.0001
91611516|NCT01380093|183117324|SUPERIORITY_OR_OTHER||LS Mean Difference|122.5|||<|0.0001|TWO_SIDED|95.0|85.7|159.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||159.2|85.7|<0.0001
91611517|NCT01380093|183117324|SUPERIORITY_OR_OTHER||LS Mean Difference|324.6|||<|0.0001|TWO_SIDED|95.0|287.7|361.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||361.5|287.7|<0.0001
91611518|NCT01380093|183117325|SUPERIORITY_OR_OTHER||LS Mean Difference|-253.0|||<|0.0001|TWO_SIDED|95.0|-301.5|-204.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-204.5|-301.5|<0.0001
91611519|NCT01380093|183117325|SUPERIORITY_OR_OTHER||LS Mean Difference|151.9|||<|0.0001|TWO_SIDED|95.0|103.5|200.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||200.2|103.5|<0.0001
91611520|NCT01380093|183117325|SUPERIORITY_OR_OTHER||LS Mean Difference|404.9|||<|0.0001|TWO_SIDED|95.0|356.4|453.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||453.3|356.4|<0.0001
91611521|NCT01380093|183117326|SUPERIORITY_OR_OTHER||LS Mean Difference|-306.8|||<|0.0001|TWO_SIDED|95.0|-370.9|-242.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-242.6|-370.9|<0.0001
91611522|NCT01380093|183117326|SUPERIORITY_OR_OTHER||LS Mean Difference|168.6|||<|0.0001|TWO_SIDED|95.0|104.7|232.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||232.6|104.7|<0.0001
91611523|NCT01380093|183117326|SUPERIORITY_OR_OTHER||LS Mean Difference|475.4|||<|0.0001|TWO_SIDED|95.0|411.3|539.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||539.6|411.3|<0.0001
91654435|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.052||||0.6764|TWO_SIDED|95.0|-0.297|0.193||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.193|-0.297|0.6764
91611524|NCT01380093|183117327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5607|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.6|0.5607
91654436|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.061||||0.6243|TWO_SIDED|95.0|-0.306|0.184||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.184|-0.306|0.6243
91611525|NCT01380093|183117327|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.2|<0.0001
91654437|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.156||||0.2151|TWO_SIDED|95.0|-0.403|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.091|-0.403|0.2151
91710415|NCT00411450|183313495|SUPERIORITY_OR_OTHER||Difference|12.5|||||TWO_SIDED|95.0|-6.3|31.4|||||Difference = Wild type - Mutant|Difference at Week 17||31.4|-6.3|
91789249|NCT04345367|183458571|OTHER||Estimate of difference|4.4|||||TWO_SIDED|95.0|-2.5|11.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.4|-2.5|
91523864|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.445
91611526|NCT01380093|183117327|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.0001|TWO_SIDED|95.0|1.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|1.0|<0.0001
91611527|NCT01380093|183117328|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-20.3|-10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-10.3|-20.3|<0.0001
91611528|NCT01380093|183117328|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.3|16.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.2|6.3|<0.0001
91611529|NCT01380093|183117328|SUPERIORITY_OR_OTHER||LS Mean Difference|26.5|||<|0.0001|TWO_SIDED|95.0|21.5|31.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.5|21.5|<0.0001
91611530|NCT01380093|183117329|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.7|||<|0.0001|TWO_SIDED|95.0|-59.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-59.5|<0.0001
91611531|NCT01380093|183117329|SUPERIORITY_OR_OTHER||LS Mean Difference|28.3|||<|0.0001|TWO_SIDED|95.0|16.5|40.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||40.1|16.5|<0.0001
91611532|NCT01380093|183117329|SUPERIORITY_OR_OTHER||LS Mean Difference|76.0|||<|0.0001|TWO_SIDED|95.0|64.2|87.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||87.8|64.2|<0.0001
91611533|NCT01380093|183117330|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-132.9|-85.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-85.6|-132.9|<0.0001
91611534|NCT01380093|183117330|SUPERIORITY_OR_OTHER||LS Mean Difference|67.0|||<|0.0001|TWO_SIDED|95.0|43.5|90.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.6|43.5|<0.0001
91611535|NCT01380093|183117330|SUPERIORITY_OR_OTHER||LS Mean Difference|176.3|||<|0.0001|TWO_SIDED|95.0|152.6|199.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||199.9|152.6|<0.0001
91611536|NCT01380093|183117331|SUPERIORITY_OR_OTHER||LS Mean Difference|-190.8|||<|0.0001|TWO_SIDED|95.0|-234.2|-147.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-147.3|-234.2|<0.0001
91611537|NCT01380093|183117331|SUPERIORITY_OR_OTHER||LS Mean Difference|134.7|||<|0.0001|TWO_SIDED|95.0|91.5|178.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||178.0|91.5|<0.0001
91654438|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.096||||0.4611|TWO_SIDED|95.0|-0.351|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.160|-0.351|0.4611
91611538|NCT01380093|183117331|SUPERIORITY_OR_OTHER||LS Mean Difference|325.5|||<|0.0001|TWO_SIDED|95.0|282.1|368.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||368.9|282.1|<0.0001
91611539|NCT01380093|183117332|SUPERIORITY_OR_OTHER||LS Mean Difference|-244.9|||<|0.0001|TWO_SIDED|95.0|-302.0|-187.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-187.7|-302.0|<0.0001
91611540|NCT01380093|183117332|SUPERIORITY_OR_OTHER||LS Mean Difference|166.5|||<|0.0001|TWO_SIDED|95.0|109.5|223.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||223.5|109.5|<0.0001
91611541|NCT01380093|183117332|SUPERIORITY_OR_OTHER||LS Mean Difference|411.4|||<|0.0001|TWO_SIDED|95.0|354.3|468.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||468.6|354.3|<0.0001
91611542|NCT01380093|183117333|SUPERIORITY_OR_OTHER||LS Mean Difference|-310.0|||<|0.0001|TWO_SIDED|95.0|-384.5|-235.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-235.5|-384.5|<0.0001
91654439|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.139||||0.2849|TWO_SIDED|95.0|-0.394|0.116||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.116|-0.394|0.2849
91789250|NCT04345367|183458571|OTHER||Estimate of difference|3.6|||||TWO_SIDED|95.0|-3.4|10.5|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||10.5|-3.4|
91523865|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
91523866|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.590
91611543|NCT01380093|183117333|SUPERIORITY_OR_OTHER||LS Mean Difference|185.2|||<|0.0001|TWO_SIDED|95.0|110.8|259.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||259.5|110.8|<0.0001
91611544|NCT01380093|183117333|SUPERIORITY_OR_OTHER||LS Mean Difference|495.1|||<|0.0001|TWO_SIDED|95.0|420.6|569.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||569.7|420.6|<0.0001
91611545|NCT01380093|183117334|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.5|||<|0.0001|TWO_SIDED|95.0|-38.7|-22.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-22.3|-38.7|<0.0001
91611546|NCT01380093|183117334|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8|||<|0.0001|TWO_SIDED|95.0|22.6|39.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.0|22.6|<0.0001
91611547|NCT01380093|183117334|SUPERIORITY_OR_OTHER||LS Mean Difference|61.3|||<|0.0001|TWO_SIDED|95.0|53.1|69.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.5|53.1|<0.0001
91611548|NCT01380093|183117335|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8671|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.8|-1.0|0.8671
91654440|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.228||||0.0833|TWO_SIDED|95.0|-0.485|0.03||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.030|-0.485|0.0833
91654441|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.017||||0.8955|TWO_SIDED|95.0|-0.277|0.242||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.242|-0.277|0.8955
91654442|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.052||||0.6916|TWO_SIDED|95.0|-0.312|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.207|-0.312|0.6916
91654443|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.159||||0.2345|TWO_SIDED|95.0|-0.421|0.103||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.103|-0.421|0.2345
91654444|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.043||||0.7466|TWO_SIDED|95.0|-0.304|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.218|-0.304|0.7466
91789251|NCT04345367|183458571|OTHER||Estimate of difference|2.0|||||TWO_SIDED|95.0|-4.9|9.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.0|-4.9|
91789252|NCT04345367|183458571|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.9|11.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.9|-1.9|
91523867|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.657
91654445|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.176||||0.1843|TWO_SIDED|95.0|-0.437|0.084||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.084|-0.437|0.1843
91654446|NCT02637557|183201459|SUPERIORITY||LS Mean Difference|-0.267||||0.0471|TWO_SIDED|95.0|-0.531|-0.003||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.003|-0.531|0.0471
91789253|NCT04345367|183458573|OTHER||Least square mean difference|-9.3|||||TWO_SIDED|95.0|-14.0|-4.6|||||Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.6|-14.0|
91789254|NCT04345367|183458573|OTHER||Least square mean difference|-12.5|||||TWO_SIDED|95.0|-17.4|-7.6|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-17.4|
91789255|NCT04345367|183458573|OTHER||Least square mean difference|-11.1|||||TWO_SIDED|95.0|-15.6|-6.6|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.6|-15.6|
91654447|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|0.088||||0.3258|TWO_SIDED|95.0|-0.088|0.265||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.265|-0.088|0.3258
91654448|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|0.084||||0.3483|TWO_SIDED|95.0|-0.092|0.261||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.261|-0.092|0.3483
91654449|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|0.022||||0.8055|TWO_SIDED|95.0|-0.156|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.201|-0.156|0.8055
91654450|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|0.103||||0.3627|TWO_SIDED|95.0|-0.119|0.326||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.326|-0.119|0.3627
91654451|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|0.087||||0.4404|TWO_SIDED|95.0|-0.135|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.310|-0.135|0.4404
91654452|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|0.001||||0.9939|TWO_SIDED|95.0|-0.224|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.226|-0.224|0.9939
91654453|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.128||||0.2716|TWO_SIDED|95.0|-0.356|0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.100|-0.356|0.2716
91710416|NCT00411450|183313495|SUPERIORITY_OR_OTHER||Difference|10.9|||||TWO_SIDED|95.0|-8.4|30.2||||||Difference at Week 25||30.2|-8.4|
91611549|NCT01380093|183117335|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0001|TWO_SIDED|95.0|0.9|2.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.7|0.9|0.0001
91611550|NCT01380093|183117335|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.0|<0.0001
91611551|NCT01380093|183117336|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.0|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-17.0|<0.0001
91611552|NCT01380093|183117336|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.8|12.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||12.8|4.8|<0.0001
91789256|NCT04345367|183458573|OTHER||Least square mean difference|-9.4|||||TWO_SIDED|95.0|-13.7|-5.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-5.1|-13.7|
91611553|NCT01380093|183117336|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|17.8|25.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||25.8|17.8|<0.0001
91654454|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.116||||0.3175|TWO_SIDED|95.0|-0.345|0.112||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.112|-0.345|0.3175
91654455|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.252||||0.0325|TWO_SIDED|95.0|-0.483|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.021|-0.483|0.0325
91654456|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.169||||0.1769|TWO_SIDED|95.0|-0.415|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.415|0.1769
91654457|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.188||||0.1343|TWO_SIDED|95.0|-0.434|0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.058|-0.434|0.1343
91654458|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.295||||0.0203|TWO_SIDED|95.0|-0.544|-0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.046|-0.544|0.0203
91654459|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.152||||0.2543|TWO_SIDED|95.0|-0.415|0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.110|-0.415|0.2543
91654460|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.142||||0.2892|TWO_SIDED|95.0|-0.405|0.121||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.121|-0.405|0.2892
91710417|NCT00411450|183313496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
91710418|NCT00411450|183313497|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0|||||Difference = Wild type - Mutant|Difference at Week 17||25|-14|
91710419|NCT00411450|183313497|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0||||||Difference at Week 25||25|-14|
91710420|NCT00411450|183313498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||2.0|0.2|
91523868|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.108
91611554|NCT01380093|183117337|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-35.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.3|-55.3|<0.0001
91611555|NCT01380093|183117337|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|14.6|34.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.5|14.6|<0.0001
91611556|NCT01380093|183117337|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8|||<|0.0001|TWO_SIDED|95.0|59.9|79.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||79.8|59.9|<0.0001
91611557|NCT01380093|183117338|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.1|||<|0.0001|TWO_SIDED|95.0|-129.3|-88.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-88.8|-129.3|<0.0001
91611558|NCT01380093|183117338|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|39.9|80.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.4|39.9|<0.0001
91611559|NCT01380093|183117338|SUPERIORITY_OR_OTHER||LS Mean Difference|169.2|||<|0.0001|TWO_SIDED|95.0|148.9|189.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||189.5|148.9|<0.0001
91611560|NCT01380093|183117339|SUPERIORITY_OR_OTHER||LS Mean Difference|-207.0|||<|0.0001|TWO_SIDED|95.0|-242.0|-172.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-172.1|-242.0|<0.0001
91611561|NCT01380093|183117339|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7|||<|0.0001|TWO_SIDED|95.0|83.9|153.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||153.5|83.9|<0.0001
91611562|NCT01380093|183117339|SUPERIORITY_OR_OTHER||LS Mean Difference|325.8|||<|0.0001|TWO_SIDED|95.0|290.8|360.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||360.7|290.8|<0.0001
91611563|NCT01380093|183117340|SUPERIORITY_OR_OTHER||LS Mean Difference|-268.2|||<|0.0001|TWO_SIDED|95.0|-313.2|-223.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-223.2|-313.2|<0.0001
91611564|NCT01380093|183117340|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0|||<|0.0001|TWO_SIDED|95.0|102.1|191.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.9|102.1|<0.0001
91611565|NCT01380093|183117340|SUPERIORITY_OR_OTHER||LS Mean Difference|415.2|||<|0.0001|TWO_SIDED|95.0|370.2|460.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||460.2|370.2|<0.0001
91611566|NCT01380093|183117341|SUPERIORITY_OR_OTHER||LS Mean Difference|-336.0|||<|0.0001|TWO_SIDED|95.0|-395.4|-276.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-276.6|-395.4|<0.0001
91611567|NCT01380093|183117341|SUPERIORITY_OR_OTHER||LS Mean Difference|165.6|||<|0.0001|TWO_SIDED|95.0|106.4|224.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||224.8|106.4|<0.0001
91611568|NCT01380093|183117341|SUPERIORITY_OR_OTHER||LS Mean Difference|501.6|||<|0.0001|TWO_SIDED|95.0|442.2|561.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||561.0|442.2|<0.0001
91611569|NCT01380093|183117342|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-40.7|-26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-26.8|-40.7|<0.0001
91611570|NCT01380093|183117342|SUPERIORITY_OR_OTHER||LS Mean Difference|26.7|||<|0.0001|TWO_SIDED|95.0|19.7|33.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.6|19.7|<0.0001
91710421|NCT00411450|183313499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.4|0.9|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||0.9|0.4|
91710422|NCT00411450|183313500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
91654461|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.306||||0.0243|TWO_SIDED|95.0|-0.571|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.040|-0.571|0.0243
91789257|NCT04345367|183458573|OTHER||Least square mean difference|-6.9|||||TWO_SIDED|95.0|-10.9|-2.9|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-2.9|-10.9|
91789258|NCT04345367|183458573|OTHER||Least square mean difference|-5.3|||||TWO_SIDED|95.0|-9.0|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-9.0|
91611571|NCT01380093|183117342|SUPERIORITY_OR_OTHER||LS Mean Difference|60.4|||<|0.0001|TWO_SIDED|95.0|53.4|67.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.4|53.4|<0.0001
91611572|NCT01380093|183117343|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.3345|TWO_SIDED|95.0|-0.4|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.4|0.3345
91611573|NCT01380093|183117343|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.5|3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.3|1.5|<0.0001
91611574|NCT01380093|183117343|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.1|<0.0001
91611575|NCT01380093|183117344|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.0453|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.0|-2.0|0.0453
91611576|NCT01380093|183117344|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.5637|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.7|0.5637
91523869|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.161
91523870|NCT00279201|182923096|SUPERIORITY_OR_OTHER|||||||0.178||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.178
91611577|NCT01380093|183117344|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.011|TWO_SIDED|95.0|0.3|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|0.3|0.0110
91611578|NCT01380093|183117345|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.9||||0.0041|TWO_SIDED|95.0|-8.2|-1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.6|-8.2|0.0041
91611579|NCT01380093|183117345|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.2178|TWO_SIDED|95.0|-1.2|5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.3|-1.2|0.2178
91611580|NCT01380093|183117345|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0|||<|0.0001|TWO_SIDED|95.0|3.7|10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.3|3.7|<0.0001
91611581|NCT01380093|183117346|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.4||||0.0001|TWO_SIDED|95.0|-28.8|-9.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.9|-28.8|0.0001
91611582|NCT01380093|183117346|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.151|TWO_SIDED|95.0|-2.6|16.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.3|-2.6|0.1510
91654462|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.059||||0.6471|TWO_SIDED|95.0|-0.312|0.194||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.194|-0.312|0.6471
91654463|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.106||||0.4123|TWO_SIDED|95.0|-0.359|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.359|0.4123
91654464|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.278||||0.0338|TWO_SIDED|95.0|-0.534|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.021|-0.534|0.0338
91789259|NCT04345367|183458573|OTHER||Least square mean difference|-3.4|||||TWO_SIDED|95.0|-7.1|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-7.1|
91789260|NCT04345367|183458574|OTHER||Least square mean difference|-11.0|||||TWO_SIDED|95.0|-14.5|-7.6|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-14.5|
91789261|NCT04345367|183458574|OTHER||Least square mean difference|-12.8|||||TWO_SIDED|95.0|-16.0|-9.5|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-9.5|-16.0|
91611583|NCT01380093|183117346|SUPERIORITY_OR_OTHER||LS Mean Difference|26.2|||<|0.0001|TWO_SIDED|95.0|16.8|35.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.7|16.8|<0.0001
91611584|NCT01380093|183117347|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-75.9|-34.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-34.4|-75.9|<0.0001
91611585|NCT01380093|183117347|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0796|TWO_SIDED|95.0|-2.2|39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.2|-2.2|0.0796
91611586|NCT01380093|183117347|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|52.9|94.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||94.4|52.9|<0.0001
91611587|NCT01380093|183117348|SUPERIORITY_OR_OTHER||LS Mean Difference|-82.8|||<|0.0001|TWO_SIDED|95.0|-112.9|-52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-52.7|-112.9|<0.0001
91654465|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.095||||0.4841|TWO_SIDED|95.0|-0.362|0.172||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.172|-0.362|0.4841
91654466|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.152||||0.2627|TWO_SIDED|95.0|-0.419|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.115|-0.419|0.2627
91654467|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.311||||0.0241|TWO_SIDED|95.0|-0.581|-0.041||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.041|-0.581|0.0241
91789262|NCT04345367|183458574|OTHER||Least square mean difference|-10.2|||||TWO_SIDED|95.0|-13.6|-6.8|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.8|-13.6|
91789263|NCT04345367|183458574|OTHER||Least square mean difference|-7.3|||||TWO_SIDED|95.0|-10.5|-4.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.1|-10.5|
91611588|NCT01380093|183117348|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.078|TWO_SIDED|95.0|-3.1|56.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||56.9|-3.1|0.0780
91611589|NCT01380093|183117348|SUPERIORITY_OR_OTHER||LS Mean Difference|109.7|||<|0.0001|TWO_SIDED|95.0|79.6|139.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||139.8|79.6|<0.0001
91611590|NCT01380093|183117349|SUPERIORITY_OR_OTHER||LS Mean Difference|-111.9|||<|0.0001|TWO_SIDED|95.0|-153.7|-70.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-70.2|-153.7|<0.0001
91611591|NCT01380093|183117349|SUPERIORITY_OR_OTHER||LS Mean Difference|33.9||||0.1089|TWO_SIDED|95.0|-7.8|75.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||75.5|-7.8|0.1089
91611592|NCT01380093|183117349|SUPERIORITY_OR_OTHER||LS Mean Difference|145.8|||<|0.0001|TWO_SIDED|95.0|104.1|187.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||187.5|104.1|<0.0001
91611593|NCT01380093|183117350|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-8.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-8.6|-18.8|<0.0001
91654468|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.093||||0.4881|TWO_SIDED|95.0|-0.355|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.355|0.4881
91654469|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.164||||0.2205|TWO_SIDED|95.0|-0.427|0.099||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.099|-0.427|0.2205
91789264|NCT04345367|183458574|OTHER||Least square mean difference|-6.1|||||TWO_SIDED|95.0|-9.3|-3.0|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-3.0|-9.3|
91789265|NCT04345367|183458574|OTHER||Least square mean difference|-4.9|||||TWO_SIDED|95.0|-8.2|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-8.2|
91789266|NCT04345367|183458574|OTHER||Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.6|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-6.6|
91789267|NCT04345367|183458575|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.4|
91710423|NCT00411450|183313501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.2|0.5|
91710424|NCT00614874|183313505|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Comparison is between baseline and week 12|ANOVA|||||||0.048
91789268|NCT04345367|183458575|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.3|
91611594|NCT01380093|183117350|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.0215|TWO_SIDED|95.0|0.9|11.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.1|0.9|0.0215
91611595|NCT01380093|183117350|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|14.6|24.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||24.8|14.6|<0.0001
91611596|NCT01380093|183117351|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0007|TWO_SIDED|95.0|-3.6|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-3.6|0.0007
91611597|NCT01380093|183117351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0455|TWO_SIDED|95.0|0.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|0.0|0.0455
91611598|NCT01380093|183117351|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6|||<|0.0001|TWO_SIDED|95.0|2.3|4.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.9|2.3|<0.0001
91611599|NCT01380093|183117352|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.3|-0.9|0.3749
91611600|NCT01380093|183117352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.7939|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-0.5|0.7939
91523871|NCT00279201|182923097|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.917
91611601|NCT01380093|183117352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2524|TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.3|0.2524
91611602|NCT01380093|183117353|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.1211|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.5|-3.8|0.1211
91611603|NCT01380093|183117353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.1997|TWO_SIDED|95.0|-0.7|3.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.5|-0.7|0.1997
91611604|NCT01380093|183117353|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.0057|TWO_SIDED|95.0|0.9|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|0.9|0.0057
91611605|NCT01380093|183117354|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8||||0.0057|TWO_SIDED|95.0|-16.7|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-16.7|0.0057
91611606|NCT01380093|183117354|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5||||0.1918|TWO_SIDED|95.0|-2.3|11.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.4|-2.3|0.1918
91611607|NCT01380093|183117354|SUPERIORITY_OR_OTHER||LS Mean Difference|14.4|||<|0.0001|TWO_SIDED|95.0|7.5|21.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||21.2|7.5|<0.0001
91710425|NCT00614874|183313506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|35.0||0.183||95.0||||comparison was at baseline and week 12|Friedman|||||||0.183
91710426|NCT00614874|183313507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.95||0.398||95.0||||Comparison was at baseline and week 12|Friedman|||||||0.398
91710427|NCT00705341|183313517|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Linear|||Log-linear generalized estimating equation (GEE) models were used to assess the dose effect on PC20.||||0.65
91710428|NCT00205660|183313519|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.03
91789269|NCT04345367|183458575|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.3|
91789270|NCT04345367|183458576|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.3|-0.3|
91654470|NCT02637557|183201460|SUPERIORITY||LS Mean Difference|-0.433||||0.0015|TWO_SIDED|95.0|-0.699|-0.168||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.168|-0.699|0.0015
91654471|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.043||||0.6653|TWO_SIDED|95.0|-0.152|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.238|-0.152|0.6653
91654472|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.15||||0.1327|TWO_SIDED|95.0|-0.046|0.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.345|-0.046|0.1327
91654473|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.043||||0.6697|TWO_SIDED|95.0|-0.155|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.155|0.6697
91654474|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.021||||0.8598|TWO_SIDED|95.0|-0.21|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.210|0.8598
91654475|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.113||||0.3354|TWO_SIDED|95.0|-0.118|0.344||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.344|-0.118|0.3354
91654476|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.055||||0.6429|TWO_SIDED|95.0|-0.179|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.289|-0.179|0.6429
91654477|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.101||||0.401|TWO_SIDED|95.0|-0.336|0.135||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.135|-0.336|0.4010
91654478|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.129||||0.2821|TWO_SIDED|95.0|-0.364|0.106||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.106|-0.364|0.2821
91710429|NCT00205660|183313520|SUPERIORITY|||||||0.01||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.01
91789271|NCT04345367|183458576|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.2|
91523872|NCT00279201|182923097|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.754
91654479|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.149||||0.2189|TWO_SIDED|95.0|-0.388|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.089|-0.388|0.2189
91789272|NCT04345367|183458576|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
91523873|NCT00279201|182923097|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.420
91654480|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.093||||0.4717|TWO_SIDED|95.0|-0.346|0.161||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.161|-0.346|0.4717
91654481|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.096||||0.4572|TWO_SIDED|95.0|-0.349|0.158||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.158|-0.349|0.4572
91654482|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.165||||0.2064|TWO_SIDED|95.0|-0.422|0.092||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.092|-0.422|0.2064
91654483|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.088||||0.4932|TWO_SIDED|95.0|-0.339|0.164||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.164|-0.339|0.4932
91654484|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.069||||0.5897|TWO_SIDED|95.0|-0.321|0.183||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.183|-0.321|0.5897
91654485|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.166||||0.2014|TWO_SIDED|95.0|-0.421|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.089|-0.421|0.2014
91654486|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.044||||0.7384|TWO_SIDED|95.0|-0.304|0.215||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.215|-0.304|0.7384
91710430|NCT03173456|183313530|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05. The plan was to only do individual comparisons between means if the overall test of the analysis of variance (AVOVA) was statistically significant|ANOVA|||The null hypothesis is that all means are equal. The alternate hypothesis is that one or more mean is less than or more than another.||||0.69
91611608|NCT01380093|183117355|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5||||0.0013|TWO_SIDED|95.0|-50.2|-12.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-12.9|-50.2|0.0013
91611609|NCT01380093|183117355|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9||||0.1136|TWO_SIDED|95.0|-3.7|33.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.5|-3.7|0.1136
91611610|NCT01380093|183117355|SUPERIORITY_OR_OTHER||LS Mean Difference|46.5|||<|0.0001|TWO_SIDED|95.0|27.8|65.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||65.1|27.8|<0.0001
91611611|NCT01380093|183117356|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.6||||0.0006|TWO_SIDED|95.0|-83.2|-24.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-24.0|-83.2|0.0006
91611612|NCT01380093|183117356|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2||||0.1207|TWO_SIDED|95.0|-6.3|52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||52.7|-6.3|0.1207
91611613|NCT01380093|183117356|SUPERIORITY_OR_OTHER||LS Mean Difference|76.8|||<|0.0001|TWO_SIDED|95.0|47.3|106.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||106.4|47.3|<0.0001
91611614|NCT01380093|183117357|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.8||||0.0008|TWO_SIDED|95.0|-118.6|-33.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-33.0|-118.6|0.0008
91611615|NCT01380093|183117357|SUPERIORITY_OR_OTHER||LS Mean Difference|31.8||||0.141|TWO_SIDED|95.0|-10.8|74.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||74.5|-10.8|0.1410
91789273|NCT04345367|183458577|OTHER||Least square mean difference|-2.0|||||TWO_SIDED|95.0|-2.6|-1.3|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.3|-2.6|
91611616|NCT01380093|183117357|SUPERIORITY_OR_OTHER||LS Mean Difference|107.7|||<|0.0001|TWO_SIDED|95.0|64.9|150.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||150.5|64.9|<0.0001
91789274|NCT04345367|183458577|OTHER||Least square mean difference|-1.0|||||TWO_SIDED|95.0|-1.6|-0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-1.6|
91611617|NCT01380093|183117358|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.0|||<|0.0001|TWO_SIDED|95.0|-14.4|-5.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.6|-14.4|<0.0001
91611618|NCT01380093|183117358|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0529|TWO_SIDED|95.0|-0.1|8.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.7|-0.1|0.0529
91611619|NCT01380093|183117358|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|9.9|18.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.7|9.9|<0.0001
91611620|NCT01380093|183117359|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0806|TWO_SIDED|95.0|-3.8|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-3.8|0.0806
91611621|NCT01380093|183117359|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.2769|TWO_SIDED|95.0|-0.9|3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.1|-0.9|0.2769
91611622|NCT01380093|183117359|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0056|TWO_SIDED|95.0|0.9|5.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.0|0.9|0.0056
91654487|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.043||||0.7423|TWO_SIDED|95.0|-0.303|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.216|-0.303|0.7423
91654488|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.141||||0.2923|TWO_SIDED|95.0|-0.404|0.122||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.122|-0.404|0.2923
91654489|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.085||||0.5388|TWO_SIDED|95.0|-0.359|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.188|-0.359|0.5388
91654490|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|0.008||||0.9565|TWO_SIDED|95.0|-0.266|0.281||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.281|-0.266|0.9565
91654491|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.099||||0.4848|TWO_SIDED|95.0|-0.376|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.376|0.4848
91654492|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.164||||0.2523|TWO_SIDED|95.0|-0.445|0.117||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.117|-0.445|0.2523
91654493|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.112||||0.4356|TWO_SIDED|95.0|-0.393|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.393|0.4356
91654494|NCT02637557|183201461|SUPERIORITY||LS Mean Difference|-0.199||||0.1706|TWO_SIDED|95.0|-0.485|0.086||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.086|-0.485|0.1706
91789275|NCT04345367|183458577|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-1.4|-0.2|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.2|-1.4|
91523874|NCT00279201|182923097|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.514
91789276|NCT04345367|183458577|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-1.2|
91789277|NCT04345367|183458577|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-1.0|
91523875|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
91523876|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.566
91654495|NCT02637557|183201462|SUPERIORITY||LS Mean Difference|-0.02||||0.7689|TWO_SIDED|95.0|-0.155|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.115|-0.155|0.7689
91654496|NCT02637557|183201462|SUPERIORITY||LS Mean Difference|0.034||||0.6287|TWO_SIDED|95.0|-0.103|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.170|-0.103|0.6287
91654497|NCT02637557|183201462|SUPERIORITY||LS Mean Difference|0.07||||0.3106|TWO_SIDED|95.0|-0.066|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.207|-0.066|0.3106
91654498|NCT02637557|183201463|SUPERIORITY||LS Mean Difference|0.0||||0.9961|TWO_SIDED|95.0|-0.1|0.101||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.101|-0.100|0.9961
91654499|NCT02637557|183201463|SUPERIORITY||LS Mean Difference|-0.008||||0.8829|TWO_SIDED|95.0|-0.109|0.094||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.094|-0.109|0.8829
91654500|NCT02637557|183201463|SUPERIORITY||LS Mean Difference|0.1||||0.0527|TWO_SIDED|95.0|-0.001|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.201|-0.001|0.0527
91789278|NCT04345367|183458578|OTHER||Least square mean difference|0.818|||||TWO_SIDED|95.0|-1.22|2.856|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.856|-1.220|
91789279|NCT04345367|183458578|OTHER||Least square mean difference|2.093|||||TWO_SIDED|95.0|-0.081|4.267|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||4.267|-0.081|
91789280|NCT04345367|183458578|OTHER||Least square mean difference|-0.816|||||TWO_SIDED|95.0|-2.914|1.281|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.281|-2.914|
91789281|NCT04345367|183458579|OTHER||Least square mean difference|-1.6|||||TWO_SIDED|95.0|-2.5|-0.7|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.7|-2.5|
91611623|NCT01380093|183117360|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.11|TWO_SIDED|95.0|-1.7|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-1.7|0.1100
91611624|NCT01380093|183117360|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9421|TWO_SIDED|95.0|-1.0|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|-1.0|0.9421
91611625|NCT01380093|183117360|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.1266|TWO_SIDED|95.0|-0.2|1.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.7|-0.2|0.1266
91611626|NCT01380093|183117361|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6||||0.0723|TWO_SIDED|95.0|-5.3|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-5.3|0.0723
91611627|NCT01380093|183117361|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.4515|TWO_SIDED|95.0|-1.7|3.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.8|-1.7|0.4515
91611628|NCT01380093|183117361|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.0121|TWO_SIDED|95.0|0.8|6.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.4|0.8|0.0121
91611629|NCT01380093|183117362|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.0||||0.0059|TWO_SIDED|95.0|-18.7|-3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.3|-18.7|0.0059
91611630|NCT01380093|183117362|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.28|TWO_SIDED|95.0|-3.5|11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.8|-3.5|0.2800
91789282|NCT04345367|183458579|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-2.2|-0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-2.2|
91611631|NCT01380093|183117362|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1||||0.0002|TWO_SIDED|95.0|7.5|22.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||22.8|7.5|0.0002
91611632|NCT01380093|183117363|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.7||||0.0001|TWO_SIDED|95.0|-54.8|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-54.8|0.0001
91611633|NCT01380093|183117363|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.1488|TWO_SIDED|95.0|-4.8|31.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.2|-4.8|0.1488
91611634|NCT01380093|183117363|SUPERIORITY_OR_OTHER||LS Mean Difference|49.9|||<|0.0001|TWO_SIDED|95.0|31.8|67.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.9|31.8|<0.0001
91789283|NCT04345367|183458579|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-1.3|0.5|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-1.3|
91611635|NCT01380093|183117364|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.1|||<|0.0001|TWO_SIDED|95.0|-88.5|-31.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.6|-88.5|<0.0001
91611636|NCT01380093|183117364|SUPERIORITY_OR_OTHER||LS Mean Difference|20.4||||0.1556|TWO_SIDED|95.0|-8.0|48.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||48.7|-8.0|0.1556
91654501|NCT00992407|183201464|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.61||||0.8595|TWO_SIDED|95.0|-7.5|6.3|||t-test, 2 sided|||Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52||6.3|-7.5|0.8595
91789284|NCT04345367|183458580|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
91789285|NCT04345367|183458580|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
91789286|NCT04345367|183458580|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
91789287|NCT04345367|183458580|OTHER||Least square mean difference|1.2|||||TWO_SIDED|95.0|-0.9|3.4|||||Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-0.9|
91654502|NCT00992407|183201465|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|1.29||||0.8118|TWO_SIDED|95.0|-9.6|12.2|||t-test, 2 sided|||Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52||12.2|-9.6|0.8118
91654503|NCT00992407|183201474|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|10.0||||0.1768|TWO_SIDED|95.0|-4.8|24.8|||Student's t-test|||Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52||24.8|-4.8|0.1768
91654504|NCT00992407|183201475|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.33||||0.9569|TWO_SIDED|95.0|-12.8|12.2|||Student's t-test|||||12.2|-12.8|0.9569
91611637|NCT01380093|183117364|SUPERIORITY_OR_OTHER||LS Mean Difference|80.4|||<|0.0001|TWO_SIDED|95.0|52.0|108.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||108.9|52.0|<0.0001
91611638|NCT01380093|183117365|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.0||||0.0001|TWO_SIDED|95.0|-124.8|-43.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-43.2|-124.8|0.0001
91611639|NCT01380093|183117365|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4||||0.1826|TWO_SIDED|95.0|-13.3|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-13.3|0.1826
91611640|NCT01380093|183117365|SUPERIORITY_OR_OTHER||LS Mean Difference|111.4|||<|0.0001|TWO_SIDED|95.0|70.6|152.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||152.2|70.6|<0.0001
91789288|NCT04345367|183458580|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-2.0|2.2|||||Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.2|-2.0|
91789289|NCT04345367|183458580|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-1.5|2.6|||||Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.6|-1.5|
91611641|NCT01380093|183117366|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-7.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-7.0|-16.4|<0.0001
91611642|NCT01380093|183117366|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0811|TWO_SIDED|95.0|-0.5|8.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.9|-0.5|0.0811
91611643|NCT01380093|183117366|SUPERIORITY_OR_OTHER||LS Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.1|20.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||20.6|11.1|<0.0001
91611644|NCT01380093|183117367|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5||||0.0007|TWO_SIDED|95.0|-3.8|-1.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.1|-3.8|0.0007
91611645|NCT01380093|183117367|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.1631|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|-0.4|0.1631
91611646|NCT01380093|183117367|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|||<|0.0001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.8|2.1|<0.0001
91611647|NCT01380093|183117368|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.2117|TWO_SIDED|95.0|-3.1|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-3.1|0.2117
91654505|NCT00992407|183201476|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|0.58||||0.5294|TWO_SIDED|95.0|-5.5|2.9|||t-test, 2 sided|||||2.9|-5.5|0.5294
91654506|NCT01521559|183201495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6||||0.0003|TWO_SIDED|95.0|13.0|40.1||P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200).|Cochran-Mantel-Haenszel||Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA \>20/200).|||40.1|13.0|0.0003
91710431|NCT03173456|183313531|SUPERIORITY|||||||0.85||||||Threshold for statistical significance was 0.05. The plan was to only compare means if the overall test of AVOVA was statistically significant.|ANOVA|||||||0.85
91789290|NCT04345367|183458580|OTHER||Least square mean difference|-1.8|||||TWO_SIDED|95.0|-4.2|0.5|||||Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-4.2|
91789291|NCT04345367|183458580|OTHER||Least square mean difference|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.5|-3.3|
91789292|NCT04345367|183458580|OTHER||Least square mean difference|0.8|||||TWO_SIDED|95.0|-1.7|3.4|||||Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.7|
91654507|NCT01521559|183201496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.1|14.0|||ANCOVA|||Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||14.0|7.1|<0.0001
91654508|NCT01521559|183201497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-148.6|||<|0.0001|TWO_SIDED|95.0|-179.8|-117.4|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||-117.4|-179.8|<0.0001
91654509|NCT01521559|183201498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.0833|TWO_SIDED|95.0|-0.3|5.5|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||5.5|-0.3|0.0833
91654510|NCT03197064|183201503|OTHER|||||||0.35|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.35
91654511|NCT03197064|183201503|OTHER|||||||0.47|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.47
91654512|NCT03197064|183201503|OTHER|||||||0.066|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.066
91654513|NCT03197064|183201504|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.72
91654514|NCT03197064|183201504|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.72
91654515|NCT03197064|183201504|OTHER|||||||0.78|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.78
91654516|NCT03197064|183201505|OTHER|||||||0.93|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.93
91523877|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.812||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.812
91654517|NCT03197064|183201505|OTHER|||||||0.39|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.39
91654518|NCT03197064|183201505|OTHER|||||||0.08|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.08
91654519|NCT03197064|183201506|OTHER|||||||0.42|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.42
91654520|NCT03197064|183201506|OTHER|||||||0.37|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.37
91654521|NCT03197064|183201506|OTHER|||||||0.49|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.49
91654522|NCT03197064|183201507|OTHER|||||||0.386|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.386
91654523|NCT03197064|183201507|OTHER|||||||0.388|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.388
91654524|NCT03197064|183201507|OTHER|||||||0.247|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.247
91654525|NCT00757601|183201524|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 AUC (0-∞).~The GMR (fed/fasted) was calculated using the geometric mean AUC (0-∞) of the fed state divided by the geometric mean AUC (0-∞) fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.03||||||95.0|||||Mixed-Effect Model|||A linear mixed-effect model was used to estimate the geometric mean AUC (0-∞) for MK1006 at every dose level.||||
91654526|NCT00757601|183201525|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 Cmax.~The GMR (fed/fasted) was calculated using the geometric mean Cmax of the fed state divided by the geometric mean Cmax fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.14||||||95.0|||||Mixed-effect Model|||A linear mixed-effect model was used to estimate the geometric mean Cmax for MK1006 at every dose level.||||
91710432|NCT03173456|183313532|SUPERIORITY|||||||0.99||||||Threshold for statistical significance = 0.05|Chi-squared|||||||0.99
91710433|NCT03173456|183313534|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
91611648|NCT01380093|183117368|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.0345|TWO_SIDED|95.0|0.2|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|0.2|0.0345
91611649|NCT01380093|183117368|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0011|TWO_SIDED|95.0|1.4|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|1.4|0.0011
91611650|NCT01380093|183117369|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.2||||0.0002|TWO_SIDED|95.0|-18.4|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-18.4|0.0002
91611651|NCT01380093|183117369|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.0081|TWO_SIDED|95.0|2.3|14.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.6|2.3|0.0081
91611652|NCT01380093|183117369|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|||<|0.0001|TWO_SIDED|95.0|14.4|26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||26.8|14.4|<0.0001
91611653|NCT01380093|183117370|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-55.6|-20.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.8|-55.6|<0.0001
91654527|NCT04543136|183201530|SUPERIORITY||Mean Difference (Final Values)|45.0||||0.074|TWO_SIDED|95.0|-4.5|94.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||94.5|-4.5|0.074
91654528|NCT04543136|183201530|SUPERIORITY||Mean Difference (Final Values)|58.8||||0.022|TWO_SIDED|95.0|8.5|109.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||109.1|8.5|0.022
91611654|NCT01380093|183117370|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4||||0.0002|TWO_SIDED|95.0|17.0|51.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||51.7|17.0|0.0002
91611655|NCT01380093|183117370|SUPERIORITY_OR_OTHER||LS Mean Difference|72.6|||<|0.0001|TWO_SIDED|95.0|55.2|90.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.0|55.2|<0.0001
91611656|NCT01380093|183117371|SUPERIORITY_OR_OTHER||LS Mean Difference|-100.3|||<|0.0001|TWO_SIDED|95.0|-142.2|-58.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-58.4|-142.2|<0.0001
91611657|NCT01380093|183117371|SUPERIORITY_OR_OTHER||LS Mean Difference|93.9|||<|0.0001|TWO_SIDED|95.0|52.1|135.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||135.7|52.1|<0.0001
91611658|NCT01380093|183117371|SUPERIORITY_OR_OTHER||LS Mean Difference|194.2|||<|0.0001|TWO_SIDED|95.0|152.3|236.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||236.1|152.3|<0.0001
91611659|NCT01380093|183117372|SUPERIORITY_OR_OTHER||LS Mean Difference|-147.4|||<|0.0001|TWO_SIDED|95.0|-205.1|-89.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-89.6|-205.1|<0.0001
91611660|NCT01380093|183117372|SUPERIORITY_OR_OTHER||LS Mean Difference|134.1|||<|0.0001|TWO_SIDED|95.0|76.5|191.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.7|76.5|<0.0001
91611661|NCT01380093|183117372|SUPERIORITY_OR_OTHER||LS Mean Difference|281.5|||<|0.0001|TWO_SIDED|95.0|223.7|339.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||339.2|223.7|<0.0001
91611662|NCT01380093|183117373|SUPERIORITY_OR_OTHER||LS Mean Difference|-201.4|||<|0.0001|TWO_SIDED|95.0|-279.3|-123.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-123.6|-279.3|<0.0001
91710434|NCT03173456|183313535|SUPERIORITY|||||||0.0501||||||0.05 was the a priori threshold for statistical significance|Chi-squared|||||||0.0501
91611663|NCT01380093|183117373|SUPERIORITY_OR_OTHER||LS Mean Difference|169.1|||<|0.0001|TWO_SIDED|95.0|91.5|246.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||246.7|91.5|<0.0001
91611664|NCT01380093|183117373|SUPERIORITY_OR_OTHER||LS Mean Difference|370.5|||<|0.0001|TWO_SIDED|95.0|292.7|448.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||448.4|292.7|<0.0001
91611665|NCT01380093|183117374|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.4|||<|0.0001|TWO_SIDED|95.0|-23.8|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-23.8|<0.0001
91611666|NCT01380093|183117374|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.1|18.3|<0.0001
91611667|NCT01380093|183117374|SUPERIORITY_OR_OTHER||LS Mean Difference|42.1|||<|0.0001|TWO_SIDED|95.0|34.7|49.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||49.5|34.7|<0.0001
91611668|NCT01380093|183117375|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.0253|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.2|-2.6|0.0253
91611669|NCT01380093|183117375|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|1.6|<0.0001
91654529|NCT04543136|183201530|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.587|TWO_SIDED|95.0|-64.2|36.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||36.6|-64.2|0.587
91654530|NCT04543136|183201531|SUPERIORITY||Mean Difference (Final Values)|54.9||||0.03|TWO_SIDED|95.0|5.3|104.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||104.4|5.3|0.030
91523878|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
91611670|NCT01380093|183117375|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2|||<|0.0001|TWO_SIDED|95.0|3.0|5.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.4|3.0|<0.0001
91611671|NCT01380093|183117376|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1||||0.0062|TWO_SIDED|95.0|-3.7|-0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.6|-3.7|0.0062
91611672|NCT01380093|183117376|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.4998|TWO_SIDED|95.0|-1.0|2.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.0|-1.0|0.4998
91611673|NCT01380093|183117376|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.2|1.1|0.0008
91611674|NCT01380093|183117377|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.0||||0.0009|TWO_SIDED|95.0|-11.1|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-11.1|0.0009
91611675|NCT01380093|183117377|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.2693|TWO_SIDED|95.0|-1.8|6.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.3|-1.8|0.2693
91611676|NCT01380093|183117377|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.3|13.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.3|5.3|<0.0001
91654531|NCT04543136|183201531|SUPERIORITY||Mean Difference (Final Values)|61.8||||0.015|TWO_SIDED|95.0|12.5|111.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||111.2|12.5|0.015
91611677|NCT01380093|183117378|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.2||||0.0042|TWO_SIDED|95.0|-27.2|-5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.3|-27.2|0.0042
91611678|NCT01380093|183117378|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1139|TWO_SIDED|95.0|-2.2|19.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||19.6|-2.2|0.1139
91611679|NCT01380093|183117378|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0|||<|0.0001|TWO_SIDED|95.0|14.1|35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.9|14.1|<0.0001
91611680|NCT01380093|183117379|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-27.7|-42.1|<0.0001
91611681|NCT01380093|183117379|SUPERIORITY_OR_OTHER||LS Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|20.1|34.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.4|20.1|<0.0001
91611682|NCT01380093|183117379|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1|||<|0.0001|TWO_SIDED|95.0|54.9|69.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.4|54.9|<0.0001
91611683|NCT01380093|183117380|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1||||0.0039|TWO_SIDED|95.0|-58.5|-11.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.7|-58.5|0.0039
91611684|NCT01380093|183117380|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3||||0.1026|TWO_SIDED|95.0|-4.0|42.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.7|-4.0|0.1026
91611685|NCT01380093|183117380|SUPERIORITY_OR_OTHER||LS Mean Difference|54.4|||<|0.0001|TWO_SIDED|95.0|31.0|77.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||77.8|31.0|<0.0001
91654532|NCT04543136|183201531|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.78|TWO_SIDED|95.0|-56.5|42.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||42.5|-56.5|0.780
91654533|NCT04543136|183201532|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.281|TWO_SIDED|95.0|-37.9|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-37.9|0.281
91789293|NCT04345367|183458580|OTHER||Least square mean difference|-4.1|||||TWO_SIDED|95.0|-6.6|-1.6|||||Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.6|-6.6|
91611686|NCT01380093|183117381|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.3||||0.0051|TWO_SIDED|95.0|-73.1|-13.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.5|-73.1|0.0051
91611687|NCT01380093|183117381|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3||||0.0941|TWO_SIDED|95.0|-4.4|55.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||55.0|-4.4|0.0941
91611688|NCT01380093|183117381|SUPERIORITY_OR_OTHER||LS Mean Difference|68.6|||<|0.0001|TWO_SIDED|95.0|38.8|98.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||98.4|38.8|<0.0001
91611689|NCT01380093|183117382|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0||||0.0083|TWO_SIDED|95.0|-85.0|-13.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.1|-85.0|0.0083
91611690|NCT01380093|183117382|SUPERIORITY_OR_OTHER||LS Mean Difference|32.3||||0.0766|TWO_SIDED|95.0|-3.5|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-3.5|0.0766
91611691|NCT01380093|183117382|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3|||<|0.0001|TWO_SIDED|95.0|45.4|117.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||117.3|45.4|<0.0001
91611692|NCT01380093|183117383|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.0||||0.0018|TWO_SIDED|95.0|-12.9|-3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.1|-12.9|0.0018
91710435|NCT01733121|183313536|OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<.0001
91611693|NCT01380093|183117383|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8||||0.0527|TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||9.7|-0.1|0.0527
91611694|NCT01380093|183117383|SUPERIORITY_OR_OTHER||LS Mean Difference|12.8|||<|0.0001|TWO_SIDED|95.0|7.9|17.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.7|7.9|<0.0001
91611695|NCT01380093|183117384|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.3986|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-1.4|0.3986
91611696|NCT01380093|183117384|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.0023|TWO_SIDED|95.0|0.6|2.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.5|0.6|0.0023
91611697|NCT01380093|183117384|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0002|TWO_SIDED|95.0|1.0|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.0|0.0002
91611698|NCT01380093|183117385|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.0029|TWO_SIDED|95.0|-18.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-18|0.0029
91611699|NCT01380093|183117385|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.0286|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||15|1|0.0286
91611700|NCT01380093|183117385|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.0|27.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||27|12|<0.0001
91611701|NCT01380093|183117386|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0||||0.005|TWO_SIDED|95.0|-22.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-22|0.0050
91611702|NCT01380093|183117386|SUPERIORITY_OR_OTHER||LS Mean Difference|8.2||||0.07|TWO_SIDED|95.0|-1.0|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17|-1|0.0700
91654534|NCT04543136|183201532|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.597|TWO_SIDED|95.0|-18.3|31.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.7|-18.3|0.597
91611703|NCT01380093|183117386|SUPERIORITY_OR_OTHER||LS Mean Difference|21.2|||<|0.0001|TWO_SIDED|95.0|12.0|30.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||30|12|<0.0001
91611704|NCT01380093|183117387|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.5|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|0.5|<0.0001
91611705|NCT01380093|183117387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.3|-0.8|<0.0001
91523879|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
91523880|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.179
91611706|NCT01380093|183117387|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-1.5|<0.0001
91611707|NCT01380093|183117388|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.9|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.9|<0.0001
91611708|NCT01380093|183117388|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.3|-2.2|<0.0001
91710436|NCT01733121|183313537|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANOVA|||||-0.4|-1.2|<0.0001
91710437|NCT01733121|183313538|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0005|TWO_SIDED|95.0|-3.7|-1.1|||ANCOVA|||||-1.1|-3.7|0.0005
91611709|NCT01380093|183117388|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.6|-3.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.6|-4.6|<0.0001
91611710|NCT01380093|183117389|SUPERIORITY_OR_OTHER||LS Mean Difference|4.9|||<|0.0001|TWO_SIDED|95.0|3.9|5.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.8|3.9|<0.0001
91611711|NCT01380093|183117389|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.3|-4.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4.3|-6.3|<0.0001
91611712|NCT01380093|183117389|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-11.1|-9.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.2|-11.1|<0.0001
91611713|NCT01380093|183117390|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6|||<|0.0001|TWO_SIDED|95.0|6.6|10.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.7|6.6|<0.0001
91611714|NCT01380093|183117390|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-15.9|-11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.8|-15.9|<0.0001
91654535|NCT04543136|183201532|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.116|TWO_SIDED|95.0|-45.1|5.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||5.0|-45.1|0.116
91789294|NCT04345367|183458580|OTHER||Least square mean difference|-3.8|||||TWO_SIDED|95.0|-6.2|-1.4|||||Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.4|-6.2|
91611715|NCT01380093|183117390|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-24.5|-20.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.4|-24.5|<0.0001
91611716|NCT01380093|183117391|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7|||<|0.0001|TWO_SIDED|95.0|8.7|14.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.7|8.7|<0.0001
91611717|NCT01380093|183117391|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-24.5|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-24.5|<0.0001
91611718|NCT01380093|183117391|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|95.0|-36.2|-30.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-30.2|-36.2|<0.0001
91611719|NCT01380093|183117392|SUPERIORITY_OR_OTHER||LS Mean Difference|17.5|||<|0.0001|TWO_SIDED|95.0|11.6|23.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||23.3|11.6|<0.0001
91611720|NCT01380093|183117392|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.7|||<|0.0001|TWO_SIDED|95.0|-43.6|-31.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.9|-43.6|<0.0001
91611721|NCT01380093|183117392|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-49.3|-61.1|<0.0001
91611722|NCT01380093|183117393|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.0001|TWO_SIDED|95.0|0.8|1.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.4|0.8|<0.0001
91611723|NCT01380093|183117393|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.5|-2.1|<0.0001
91789295|NCT04345367|183458580|OTHER||Least square mean difference|-1.7|||||TWO_SIDED|95.0|-4.1|0.7|||||Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-4.1|
91654536|NCT04543136|183201533|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.787|TWO_SIDED|95.0|-21.2|27.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||27.9|-21.2|0.787
91654537|NCT04543136|183201533|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.576|TWO_SIDED|95.0|-17.6|31.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.3|-17.6|0.576
91654538|NCT04543136|183201533|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.775|TWO_SIDED|95.0|-28.1|21.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.0|-28.1|0.775
91654539|NCT04543136|183201534|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.766|TWO_SIDED|95.0|-0.7|0.52||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.52|-0.70|0.766
91654540|NCT04543136|183201534|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.032|TWO_SIDED|95.0|-1.3|-0.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.06|-1.30|0.032
91654541|NCT04543136|183201534|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.063|TWO_SIDED|95.0|-0.03|1.21||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.21|-0.03|0.063
91654542|NCT04543136|183201535|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.213|TWO_SIDED|95.0|-0.12|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.12|0.213
91611724|NCT01380093|183117393|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-2.6|-3.2|<0.0001
91611725|NCT01380093|183117394|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.0262|TWO_SIDED|95.0|0.3|4.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.6|0.3|0.0262
91654543|NCT04543136|183201535|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.291|TWO_SIDED|95.0|-0.16|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-0.16|0.291
91654544|NCT04543136|183201535|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.868|TWO_SIDED|95.0|-0.31|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-0.31|0.868
91789296|NCT04345367|183458580|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|-1.6|3.6|||||Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.6|-1.6|
91654545|NCT04543136|183201536|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.661|TWO_SIDED|95.0|-0.35|0.55||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.55|-0.35|0.661
91654546|NCT04543136|183201536|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.218|TWO_SIDED|95.0|-0.75|0.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.17|-0.75|0.218
91710438|NCT01733121|183313539|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||ANOVA|||||-0.5|-1.2|<.0001
91789297|NCT04345367|183458580|OTHER||Least square mean difference|2.9|||||TWO_SIDED|95.0|0.4|5.4|||||Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||5.4|0.4|
91789298|NCT04345367|183458580|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.9|3.4|||||Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.9|
91789299|NCT04345367|183458580|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.8|1.3|||||Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.3|-2.8|
91789300|NCT04345367|183458580|OTHER||Least square mean difference|-2.4|||||TWO_SIDED|95.0|-4.4|-0.4|||||Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-4.4|
91523881|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.377||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.377
91523882|NCT00279201|182923098|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
91523883|NCT00696384|182923126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-9.78|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-5.78|-9.78|<0.001
91523884|NCT00696384|182923127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.47|-9.29||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-9.29|-15.47|<0.001
91523885|NCT03881696|182923180|SUPERIORITY||Odds Ratio (OR)|27.853|||<|1e-05|TWO_SIDED|95.0|9.1274|111.2144||The a priori threshold for statistical significance was p \< 0.0001 at the interim analysis OR p \< 0.05 at the final analysis. Gatekeeping and multiple testing strategies were performed to ensure the overall family-wise error rate was ≤ 5%.|Fisher Exact||The odds ratio (OR) represents the odds of success among subjects randomized to omalizumab (numerator) compared to the odds of success among subjects randomized to placebo (denominator, reference group).|The null hypothesis is that the odds of 'success' (defined as consumption of a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1) in omalizumab and placebo for omalizumab arms are equal. Participants missing the blinded OFC to peanut at the end of Stage 1 will be considered a 'failure' for the primary efficacy endpoint.||111.2144|9.1274|<0.00001
91523886|NCT05690776|182923277|SUPERIORITY||Mean Difference (Final Values)|12.1|STANDARD_DEVIATION|10.0|<|0.0001|TWO_SIDED|95.0|9.2|15.0|||paired t-test|||||15.0|9.2|<0.0001
91523887|NCT05690776|182923278|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.133|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||paired t-test|||||0.128|0.053|<0.0001
91611726|NCT01380093|183117394|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.418|TWO_SIDED|95.0|-1.3|3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.0|-1.3|0.4180
91523888|NCT05690776|182923280|SUPERIORITY||Mean Difference (Final Values)|20.7|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|16.9|24.5|||paired t-test|||||24.5|16.9|<0.0001
91523889|NCT02202434|182923284|NON_INFERIORITY|10.5% non-inferiority margin|Difference in Percentages|3.1||||0.0027|ONE_SIDED|97.5||8.32|||Farrington-Manning|||||8.32||0.0027
91523890|NCT02202434|182923285|NON_INFERIORITY|9.5% Non-Inferiority margin|Difference in Percentages|-10.1|||<|0.0001|ONE_SIDED|97.5||-4.41|||Farrington-Manning|||||-4.41||<0.0001
91523891|NCT02202434|182923285|SUPERIORITY||Difference in Percentages|-10.2||||0.0006|TWO_SIDED|95.0|-16.3|-4.0|||Chi-squared|||"Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population."||-4.0|-16.3|0.0006
91523892|NCT02202434|182923286|SUPERIORITY||Difference in Percentages|-6.1|||<|0.0001|TWO_SIDED|95.0|-9.6|-2.6|||Chi-squared|||||-2.6|-9.6|<0.0001
91523893|NCT02670538|182923327|SUPERIORITY||Least Squares (LS) Mean Difference|-2.5||||0.0417|TWO_SIDED|95.0|-4.6|-0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.4|-4.6|0.0417
91523894|NCT02670538|182923327|SUPERIORITY||LS Mean Difference|-1.8||||0.1051|TWO_SIDED|95.0|-3.9|0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.4|-3.9|0.1051
91523895|NCT02670538|182923328|SUPERIORITY||LS Mean Difference|-0.3||||0.0417|TWO_SIDED|95.0|-0.6|-0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.1|-0.6|0.0417
91523896|NCT02670538|182923328|SUPERIORITY||LS Mean Difference|-0.2||||0.137|TWO_SIDED|95.0|-0.4|0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.1|-0.4|0.1370
91523897|NCT02243202|182923329|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8|||Mixed Model for Repeated Measures|||||-1.8|-5.3|<0.001
91523898|NCT02243202|182923329|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.142|TWO_SIDED|95.0|-3.1|0.4|||Mixed Model for Repeated Measures|||||0.4|-3.1|0.142
91523899|NCT02243202|182923329|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-8.6|-5.2|||Mixed Model for Repeated Measures|||||-5.2|-8.6|<0.001
91523900|NCT02243202|182923330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.15||||0.002|TWO_SIDED|95.0|1.7|10.14|||Generalized linear Mixed Model|||||10.14|1.70|0.002
91710439|NCT01151345|183313551|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|88.65|||||TWO_SIDED|90.0|81.23|96.75||||||Natural-log transformed AUC (0-t) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||96.75|81.23|
91611727|NCT01380093|183117394|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1479|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-3.7|0.1479
91611728|NCT01380093|183117395|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0181|TWO_SIDED|90.0|0.07|0.35|||Mixed Models Analysis|||Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.35|0.07|0.0181
91611729|NCT01380093|183117396|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.75|||<|0.0001|TWO_SIDED|90.0|0.68|0.83|||Mixed Models Analysis|||Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.83|0.68|<0.0001
91611730|NCT01380093|183117397|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.77||||0.0004|TWO_SIDED|90.0|0.69|0.86|||Mixed Models Analysis|||Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.86|0.69|0.0004
91611731|NCT01380093|183117398|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86||||0.0065|TWO_SIDED|90.0|0.79|0.94|||Mixed Models Analysis|||Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.94|0.79|0.0065
91611732|NCT01380093|183117399|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.98||||0.6399|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|||Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.06|0.91|0.6399
91611733|NCT01380093|183117400|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0||||0.9057|TWO_SIDED|90.0|0.94|1.08|||Mixed Models Analysis|||Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.08|0.94|0.9057
91611734|NCT01380093|183117401|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03||||0.425|TWO_SIDED|90.0|0.97|1.1|||Mixed Models Analysis|||Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.10|0.97|0.4250
91523901|NCT02243202|182923330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.825|TWO_SIDED|95.0|0.41|3.06|||Generalized linear Mixed Model|||||3.06|0.41|0.825
91611735|NCT01380093|183117402|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1||||0.0204|TWO_SIDED|90.0|1.03|1.18|||Mixed Models Analysis|||Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.18|1.03|0.0204
91611736|NCT01380093|183117403|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32||||0.0005|TWO_SIDED|90.0|1.17|1.49|||Mixed Models Analysis|||Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.49|1.17|0.0005
91611737|NCT01342640|183117425|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.||||<0.0001
91611738|NCT01342640|183117426|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.||||<.0001
91611739|NCT01342640|183117427|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.||||<.0001
91611740|NCT01849250|183117460|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||.50
91611741|NCT01849250|183117463|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||.19
91611742|NCT01849250|183117464|SUPERIORITY|||||||0.52|||||||ANOVA|||||||.52
91611743|NCT01849250|183117465|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||.12
91611744|NCT03503773|183117519|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.2682|TWO_SIDED|95.0|-4.8|1.7|||ANCOVA||There was no formal hypothesis testing conducted in the study. 95% CIs are intended to be descriptive in nature only|The null hypothesis to be tested is that there is no difference in the change in 24 hour mean SBP between treatment and sham control. The Type I error rate for rejecting the null hypothesis will be set at an alpha level of 0.05.||1.7|-4.8|0.2682
91611745|NCT03503773|183117520|SUPERIORITY|||||||0.6964|||||||ANCOVA|||Difference between treatment arms||||0.6964
91611746|NCT03503773|183117521|SUPERIORITY|||||||0.0775|||||||ANCOVA|||Between group difference||||0.0775
91611747|NCT03503773|183117523|SUPERIORITY|||||||0.4734|||||||ANCOVA|||Between group difference||||0.4734
91611748|NCT03503773|183117525|SUPERIORITY|||||||0.0341|||||||ANCOVA|||||||0.0341
91611749|NCT03503773|183117527|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.573|TWO_SIDED|95.0|-0.132|0.073|||Fisher Exact|||||0.073|-0.132|0.573
91611750|NCT05341466|183117547|SUPERIORITY||Mean Difference (Net)|0.528|STANDARD_ERROR_OF_MEAN|0.188||0.0098|||||||Mixed Models Analysis|||||||0.0098
91611751|NCT05341466|183117547|OTHER||Adjusted R-squared|0.418||||0.014|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step length asymmetry.||||0.014
91611752|NCT05341466|183117547|OTHER||Adjusted R-squared|0.496||||0.006|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step time asymmetry.||||0.006
91611753|NCT05341466|183117547|OTHER||Adjusted R-squared|0.666||||0.001|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus changes in net metabolic power.||||0.001
91611754|NCT05341466|183117548|SUPERIORITY||Median Difference (Net)|-0.0042|STANDARD_DEVIATION|0.0232||0.744|||||||ANOVA|||||||0.744
91611755|NCT05341466|183117549|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.0231||0.269|||||||ANOVA|||||||0.269
91611756|NCT05341466|183117550|SUPERIORITY||Median Difference (Net)|-0.4|STANDARD_DEVIATION|0.681||0.02|||||||ANOVA|||||||0.020
91611757|NCT01208181|183117596|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.29||||0.004|TWO_SIDED|95.0|-0.49|-0.09|||Tukey-Ciminera-Heysetrend test|||||-0.09|-0.49|0.004
91611758|NCT01208181|183117596|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.27||||0.034|TWO_SIDED|95.0|-0.48|-0.06|||Tukey-Ciminera-Heysetrend test|||||-0.06|-0.48|0.034
91611759|NCT01208181|183117597|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-7.99|||<|0.001|TWO_SIDED|95.0|-11.85|-4.13|||Tukey-Ciminera-Heyse trend test|||||-4.13|-11.85|<0.001
91611760|NCT01208181|183117597|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-10.7|||<|0.001|TWO_SIDED|95.0|-14.74|-6.66|||Tukey-Ciminera-Heyse trend test|||||-6.66|-14.74|<0.001
91611761|NCT01208181|183117598|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|0.02||||0.73|TWO_SIDED|95.0|-0.1|0.14|||Tukey-Ciminera-Heysetrend test|||||0.14|-0.10|0.730
91611762|NCT01208181|183117599|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-2.71||||0.019|TWO_SIDED|95.0|-4.98|-0.45|||Tukey-Ciminera-Heyse trend test|||||-0.45|-4.98|0.019
91611763|NCT01208181|183117600|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares mean|1.61||||0.327|TWO_SIDED|80.0|-0.49|3.71|||covariance model|||||3.71|-0.49|0.327
91611764|NCT00477451|183117603|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
91611765|NCT00477451|183117604|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||0.368
91611766|NCT00477451|183117605|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||0.207
91611767|NCT03245814|183117628|SUPERIORITY||Odds Ratio (OR)|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.42|||Ordinal cumulative probability model|Covariates included baseline score \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.42|0.12|<.001
91611768|NCT03245814|183117629|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.40|0.11|<.001
91611769|NCT03245814|183117630|SUPERIORITY||Odds Ratio (OR)|0.45||||0.02|TWO_SIDED|95.0|0.23|0.86|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.86|0.23|.02
91611770|NCT03245814|183117631|SUPERIORITY||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.5|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.50|0.13|<.001
91654547|NCT04543136|183201536|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED|95.0|-0.08|0.85||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.85|-0.08|0.100
91611771|NCT03245814|183117632|SUPERIORITY||Odds Ratio (OR)|0.34||||0.001|TWO_SIDED|95.0|0.18|0.64|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.64|0.18|.001
91611772|NCT03245814|183117633|SUPERIORITY||Odds Ratio (OR)|2.83||||0.003|TWO_SIDED|95.0|1.47|5.45|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||5.45|1.47|.003
91611773|NCT03245814|183117634|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.48|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.48|0.12|<.001
91611774|NCT03245814|183117635|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.0|7.38|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.38|2.00|<.001
91611775|NCT03245814|183117636|SUPERIORITY||Odds Ratio (OR)|4.49|||<|0.001|TWO_SIDED|95.0|2.28|8.83|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||8.83|2.28|<.001
91611776|NCT03245814|183117637|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.001|TWO_SIDED|95.0|1.88|7.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.40|1.88|<.001
91611777|NCT03245814|183117638|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.22|4.47|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||4.47|1.22|.02
91611778|NCT03245814|183117639|SUPERIORITY||Odds Ratio (OR)|0.39||||0.009|TWO_SIDED|95.0|0.2|0.75|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.75|0.20|.009
91611779|NCT03245814|183117640|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED||||||Mixed Models Analysis|Mixed effects regression models to account for repeated measures (multiple assessments per day) within individuals.||||||0.002
91611780|NCT01096667|183117650|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.97||||0.034|TWO_SIDED|80.0|-5.05|-0.89||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.89|-5.05|0.034
91654548|NCT04543136|183201537|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.701|TWO_SIDED|95.0|-0.8|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.80|0.701
91654549|NCT04543136|183201537|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.438|TWO_SIDED|95.0|-0.96|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.96|0.438
91654550|NCT04543136|183201537|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.689|TWO_SIDED|95.0|-0.55|0.83||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.83|-0.55|0.689
91789301|NCT04345367|183458580|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.3|-0.3|||||Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.3|
91789302|NCT04345367|183458580|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-3.0|0.7|||||Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-3.0|
91611781|NCT01096667|183117650|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.0||||0.01|TWO_SIDED|80.0|-6.17|-1.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.82|-6.17|0.010
91654551|NCT04543136|183201538|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.309|TWO_SIDED|95.0|-0.92|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-0.92|0.309
91654552|NCT04543136|183201538|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.109|TWO_SIDED|95.0|-1.1|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.10|0.109
91611782|NCT01096667|183117650|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.69||||0.012|TWO_SIDED|80.0|-5.78|-1.6||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.60|-5.78|0.012
91654553|NCT04543136|183201538|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.555|TWO_SIDED|95.0|-0.43|0.79||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.79|-0.43|0.555
91789303|NCT04345367|183458580|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.0|-0.5|||||Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-4.0|
91789304|NCT04345367|183458580|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.5|0.9|||||Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.9|-2.5|
91789305|NCT04345367|183458580|OTHER||Least square mean difference|-2.2|||||TWO_SIDED|95.0|-4.0|-0.3|||||Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.0|
91789306|NCT04345367|183458580|OTHER||Least square mean difference|-2.9|||||TWO_SIDED|95.0|-4.8|-1.1|||||Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.1|-4.8|
91654554|NCT04543136|183201539|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.896|TWO_SIDED|95.0|-0.35|0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.31|-0.35|0.896
91654555|NCT04543136|183201539|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.32|TWO_SIDED|95.0|-0.49|0.16||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.16|-0.49|0.320
91789307|NCT04345367|183458580|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4|||||Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-3.2|
91789308|NCT04345367|183458581|OTHER||Least square mean difference|-1.1|||||TWO_SIDED|95.0|-1.5|-0.8|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.8|-1.5|
91789309|NCT04345367|183458581|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-0.8|-0.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.1|-0.8|
91789310|NCT04345367|183458581|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.6|
91789311|NCT04345367|183458581|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-0.6|
91789312|NCT04345367|183458581|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.5|
91789313|NCT04345367|183458582|OTHER||Least square mean difference|18.1|||||TWO_SIDED|95.0|10.5|25.7||||||Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.||25.7|10.5|
91789314|NCT04345367|183458583|OTHER||Estimate of difference|13.7|||||TWO_SIDED|95.0|7.3|20.1|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|7.3|
91654556|NCT04543136|183201539|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.19|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-0.19|0.390
91789315|NCT04345367|183458583|OTHER||Estimate of difference|3.9|||||TWO_SIDED|95.0|-1.6|9.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.4|-1.6|
91789316|NCT04345367|183458583|OTHER||Estimate of difference|-1.6|||||TWO_SIDED|95.0|-7.1|4.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||4.0|-7.1|
91654557|NCT04543136|183201540|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.802|TWO_SIDED|95.0|-0.51|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.51|0.802
91611783|NCT01096667|183117650|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.21||||0.024|TWO_SIDED|80.0|-5.3|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.13|-5.30|0.024
91611784|NCT01096667|183117652|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.018|TWO_SIDED|80.0|-5.94|-1.46||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.46|-5.94|0.018
91611785|NCT01096667|183117652|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.43||||0.008|TWO_SIDED|80.0|-6.78|-2.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.09|-6.78|0.008
91611786|NCT01096667|183117652|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99||||0.002|TWO_SIDED|80.0|-7.24|-2.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.74|-7.24|0.002
91789317|NCT04345367|183458583|OTHER||Estimate of difference|-2.0|||||TWO_SIDED|95.0|-7.6|3.6|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||3.6|-7.6|
91611787|NCT01096667|183117652|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.92||||0.013|TWO_SIDED|80.0|-6.16|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.67|-6.16|0.013
91611788|NCT01096667|183117653|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.152|TWO_SIDED|80.0|-4.93|0.54||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.54|-4.93|0.152
91611789|NCT01096667|183117653|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.18||||0.078|TWO_SIDED|80.0|-6.06|-0.3||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.30|-6.06|0.078
91611790|NCT01096667|183117653|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.02||||0.174|TWO_SIDED|80.0|-4.79|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.79|0.174
91654558|NCT04543136|183201540|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.082|TWO_SIDED|95.0|-0.85|0.05||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.05|-0.85|0.082
91789318|NCT04345367|183458583|OTHER||Estimate of difference|-4.2|||||TWO_SIDED|95.0|-10.3|1.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||1.9|-10.3|
91789319|NCT01755026|183458622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|191.0|STANDARD_ERROR_OF_MEAN|166.01|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
91789320|NCT03836001|183458623|SUPERIORITY|||||||0.59||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.59
91611791|NCT01096667|183117653|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.174|TWO_SIDED|80.0|-4.77|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.77|0.174
91611792|NCT01096667|183117655|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.01||||0.047|TWO_SIDED|80.0|-7.09|-0.94||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-0.94|-7.09|0.047
91611793|NCT01096667|183117655|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.16||||0.002|TWO_SIDED|80.0|-10.25|-4.07||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-4.07|-10.25|0.002
91611794|NCT01096667|183117655|SUPERIORITY_OR_OTHER||Difference in least squares means|-6.2||||0.005|TWO_SIDED|80.0|-9.28|-3.11||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-3.11|-9.28|0.005
91611795|NCT01096667|183117655|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.37||||0.033|TWO_SIDED|80.0|-7.41|-1.33||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.33|-7.41|0.033
91611796|NCT01096667|183117657|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.66||||0.007|TWO_SIDED|80.0|-4.03|-1.29||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.29|-4.03|0.007
91789321|NCT03836001|183458624|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
91789322|NCT03836001|183458625|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
91789323|NCT03836001|183458626|SUPERIORITY|||||||0.67||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.67
91611797|NCT01096667|183117657|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.11||||0.003|TWO_SIDED|80.0|-4.55|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.67|-4.55|0.003
91611798|NCT01096667|183117657|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.27||||0.018|TWO_SIDED|80.0|-3.65|-0.88||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.88|-3.65|0.018
91789324|NCT03836001|183458627|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
91789325|NCT03836001|183458628|OTHER||Mean Difference (Net)|-0.11||||0.09|TWO_SIDED|95.0|-0.24|0.02||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.02|-0.24|0.09
91789326|NCT03836001|183458629|SUPERIORITY||Mean Difference (Net)|-0.08||||0.16|TWO_SIDED|95.0|-0.19|0.03||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.03|-0.19|0.16
91789327|NCT03836001|183458631|OTHER||Mean Difference (Net)|-0.25||||0.002|TWO_SIDED|95.0|-0.41|-0.09||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||-0.09|-0.41|0.002
91611799|NCT01096667|183117657|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.021|TWO_SIDED|80.0|-3.56|-0.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.82|-3.56|0.021
91611800|NCT01096667|183117658|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.99||||0.004|TWO_SIDED|80.0|-4.43|-1.55||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.55|-4.43|0.004
91611801|NCT01096667|183117658|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.75||||0.01|TWO_SIDED|80.0|-4.26|-1.24||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.24|-4.26|0.010
91611802|NCT01096667|183117658|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.01|TWO_SIDED|80.0|-4.09|-1.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.19|-4.09|0.010
91611803|NCT01096667|183117658|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.57||||0.011|TWO_SIDED|80.0|-4.0|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.13|-4.00|0.011
91611804|NCT01096667|183117659|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.5||||0.048|TWO_SIDED|80.0|-4.43|-0.57||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.57|-4.43|0.048
91611805|NCT01096667|183117659|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.54||||0.013|TWO_SIDED|80.0|-5.58|-1.51||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.51|-5.58|0.013
91611806|NCT01096667|183117659|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88||||0.111|TWO_SIDED|80.0|-3.82|0.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.09|-3.82|0.111
91611807|NCT01096667|183117659|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.58||||0.148|TWO_SIDED|80.0|-3.51|0.36||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.36|-3.51|0.148
91611808|NCT01096667|183117661|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.2||||0.196|TWO_SIDED|80.0|-3.01|0.6||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.60|-3.01|0.196
91611809|NCT01096667|183117661|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.05||||0.229|TWO_SIDED|80.0|-2.86|0.77||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.77|-2.86|0.229
91611810|NCT01096667|183117661|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.02||||0.017|TWO_SIDED|80.0|-4.83|-1.2||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.20|-4.83|0.017
91611811|NCT01096667|183117661|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.84||||0.021|TWO_SIDED|80.0|-4.63|-1.06||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.06|-4.63|0.021
91611812|NCT01096667|183117663|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.22||||0.039|TWO_SIDED|80.0|-3.83|-0.61||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.61|-3.83|0.039
91611813|NCT01096667|183117663|SUPERIORITY_OR_OTHER||Difference in least squares means|0.07||||0.521|TWO_SIDED|80.0|-1.63|1.77||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.77|-1.63|0.521
91611814|NCT01096667|183117663|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.39||||0.031|TWO_SIDED|80.0|-4.02|-0.75||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.75|-4.02|0.031
91654559|NCT04543136|183201540|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.137|TWO_SIDED|95.0|-0.11|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.11|0.137
91791184|NCT03123185|183460135|OTHER|No hypothesis was tested and no acceptance range was specified.|gMean ratio (%)|194.18|STANDARD_ERROR_OF_MEAN|26.4|||TWO_SIDED|90.0|158.912|237.267|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||237.267|158.912|
91791185|NCT03123185|183460136|OTHER||Slope|0.4879|STANDARD_ERROR_OF_MEAN|0.0546|||TWO_SIDED|95.0|0.3767|0.599|||||Based on the estimate for slope parameter, a 2-sided 95% Confidence Interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.5990|0.3767|
91611815|NCT01096667|183117663|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.56||||0.11|TWO_SIDED|80.0|-3.19|0.07||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.07|-3.19|0.110
91611816|NCT01096667|183117664|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.38||||0.007|TWO_SIDED|80.0|-5.13|-1.63||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.63|-5.13|0.007
91611817|NCT01096667|183117664|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.37|TWO_SIDED|80.0|-2.33|1.38||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.38|-2.33|0.370
91611818|NCT01096667|183117664|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.029|TWO_SIDED|80.0|-4.43|-0.87||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.87|-4.43|0.029
91611819|NCT01096667|183117664|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.64||||0.118|TWO_SIDED|80.0|-3.42|0.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.13|-3.42|0.118
91611820|NCT01096667|183117665|SUPERIORITY_OR_OTHER||Difference in least squares means|0.02||||0.506|TWO_SIDED|80.0|-1.96|2.0||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||2.00|-1.96|0.506
91611821|NCT01096667|183117665|SUPERIORITY_OR_OTHER||Difference in least squares means|1.61||||0.838|TWO_SIDED|80.0|-0.49|3.71||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||3.71|-0.49|0.838
91611822|NCT01096667|183117665|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.82||||0.123|TWO_SIDED|80.0|-3.82|0.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.19|-3.82|0.123
91611823|NCT01096667|183117665|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.07||||0.246|TWO_SIDED|80.0|-3.06|0.93||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.93|-3.06|0.246
91611824|NCT01096667|183117667|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.2||||0.005|TWO_SIDED|80.0|-6.3|-2.1||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-2.10|-6.30|0.005
91611825|NCT01096667|183117667|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.12||||0.248|TWO_SIDED|80.0|-3.23|0.99||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.99|-3.23|0.248
91654560|NCT04543136|183201541|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.525|TWO_SIDED|95.0|-0.89|0.46||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.46|-0.89|0.525
91654561|NCT04543136|183201541|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.098|TWO_SIDED|95.0|-1.24|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.24|0.098
91654562|NCT04543136|183201541|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.306|TWO_SIDED|95.0|-0.33|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|-0.33|0.306
91654563|NCT04684524|183201551|SUPERIORITY||Least squares (LS) Mean Difference|-7.36|||<|0.0001|TWO_SIDED|95.0|-9.38|-5.35|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-5.35|-9.38|<0.0001
91654564|NCT04684524|183201552|SUPERIORITY||LS Mean Difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.56|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-0.56|-1.18|<0.0001
91654565|NCT04684524|183201553|SUPERIORITY||LS Mean Difference|-2.36|||<|0.0001|TWO_SIDED|95.0|-3.31|-1.41|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-1.41|-3.31|<0.0001
91789328|NCT01978938|183458634|NON_INFERIORITY|The NI test was based on the lower limit of the 2-sided 95% confidence interval (CI), using the method proposed without stratification by Miettinen and Nurminen. If the lower limit of the 95% CI for the difference in Responder (clinical cure and microbiologic success) rates in the micro-ITT population exceeded -10%, then the null hypothesis was rejected and the NI of eravacycline to levofloxacin was declared.|Treatment Difference|-6.5|||||TWO_SIDED|95.0|-14.1|1.2||||||For the FDA, an NI margin of 10% was used, which was based on historical data regarding the treatment effect of antibiotics. A 10% NI margin for the Responder outcome is robust and can sufficiently confirm a clinically meaningful treatment effect of eravacycline in the treatment of cUTI.||1.2|-14.1|
91523902|NCT02243202|182923330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.001|TWO_SIDED|95.0|4.15|25.05|||Generalized linear Mixed Model|||||25.05|4.15|<0.001
91611826|NCT01096667|183117667|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.84||||0.01|TWO_SIDED|80.0|-5.95|-1.73||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.73|-5.95|0.010
91611827|NCT01096667|183117667|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.33||||0.02|TWO_SIDED|80.0|-5.4|-1.25||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.25|-5.40|0.020
91611828|NCT01096667|183117669|SUPERIORITY_OR_OTHER||Difference in least squares means|42.18||||0|TWO_SIDED|80.0|31.42|52.94||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||52.94|31.42|0.000
91611829|NCT01096667|183117669|SUPERIORITY_OR_OTHER||Difference in least squares means|60.39||||0|TWO_SIDED|80.0|49.47|71.31||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||71.31|49.47|0.000
91789329|NCT02650921|183458638|SUPERIORITY||Difference in Responder Rate|64.7|||<|0.0001|TWO_SIDED|95.0|53.3|76.1|||McNemar|||||76.1|53.3|<0.0001
91523903|NCT02243202|182923331|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.8||0.456|TWO_SIDED|95.0|-2.1|4.8|||Mixed Model for Repeated Measures|||||4.8|-2.1|0.456
91523904|NCT02243202|182923331|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.8||0.827|TWO_SIDED|95.0|-3.9|3.1|||Mixed Model for Repeated Measures|||||3.1|-3.9|0.827
91523905|NCT02243202|182923331|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.7||0.015|TWO_SIDED|95.0|-7.7|-0.8|||Mixed Model for Repeated Measures|||||-0.8|-7.7|0.015
91523906|NCT02243202|182923332|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.7|||Mixed Model for Repeated Measures|||||-1.7|-5.3|<0.001
91523907|NCT02243202|182923332|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.153|TWO_SIDED|95.0|-3.1|0.5|||Mixed Model for Repeated Measures|||||0.5|-3.1|0.153
91523908|NCT02243202|182923332|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-8.5|-4.9|||Mixed Model for Repeated Measures|||||-4.9|-8.5|<0.001
91523909|NCT02207725|182923351|SUPERIORITY||Hodges-Lehman estimate of shift|-74.55|||<|0.0001|TWO_SIDED|95.0|-78.39|-66.28|||2-sided test exact Wilcoxon rank-sum tes|||||-66.28|-78.39|<0.0001
91523910|NCT02207725|182923351|SUPERIORITY||Hodges-Lehman estimate of shift|-59.5|||<|0.0001|TWO_SIDED|95.0|-64.1|-55.17|||2-sided test exact Wilcoxon rank-sum tes|||||-55.17|-64.10|<0.0001
91523911|NCT02207725|182923352|SUPERIORITY||Hodges-Lehman estimate of shift|-77.14|||<|0.0001|TWO_SIDED|95.0|-79.98|-74.04|||2-sided test exact Wilcoxon rank-sum tes|||||-74.04|-79.98|<0.0001
91523912|NCT02207725|182923354|SUPERIORITY||Hodges-Lehman estimate of shift|-7.09|||<|0.0001|TWO_SIDED|95.0|-8.86|-5.42|||2-sided test exact Wilcoxon rank-sum tes|||||-5.42|-8.86|<0.0001
91523913|NCT02207725|182923354|SUPERIORITY||Hodges-Lehman estimate of shift|-3.02||||0.0002|TWO_SIDED|95.0|-5.66|-1.25|||2-sided test exact Wilcoxon rank-sum tes|||||-1.25|-5.66|0.0002
91523914|NCT02207725|182923355|SUPERIORITY||Hodges-Lehman estimate of shift|1227.35|||<|0.0001|TWO_SIDED|95.0|984.01|1456.38|||2-sided test exact Wilcoxon rank-sum tes|||||1456.38|984.01|<0.0001
91611830|NCT01096667|183117669|SUPERIORITY_OR_OTHER||Difference in least squares means|70.34||||0|TWO_SIDED|80.0|59.58|81.1||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||81.10|59.58|0.000
91611831|NCT01096667|183117669|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.63||||0.713|TWO_SIDED|80.0|-15.22|5.96||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||5.96|-15.22|0.713
91789330|NCT02650921|183458639|SUPERIORITY||Difference in Responder Rate|72.3|||<|0.0001|TWO_SIDED|95.0|61.9|82.7|||McNemar|||||82.7|61.9|<0.0001
91789331|NCT02650921|183458640|SUPERIORITY||Difference in Responder Rate|57.3|||<|0.0001|TWO_SIDED|95.0|44.8|69.8|||McNemar|||||69.8|44.8|<0.0001
91523915|NCT02207725|182923355|SUPERIORITY||Hodges-Lehman estimate of shift|999.33|||<|0.0001|TWO_SIDED|95.0|819.5|1200.53|||2-sided test exact Wilcoxon rank-sum tes|||||1200.53|819.50|<0.0001
91523916|NCT00708435|182923399|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in effective hemostasis (%)|7.1|||||TWO_SIDED|95.0|-5.8|19.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with hemostasis.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||19.9|-5.8|
91611832|NCT01096667|183117671|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1||||0.007|TWO_SIDED|80.0|-27.45|-8.75||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-8.75|-27.45|0.007
91611833|NCT01096667|183117671|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-44.19|-25.43||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-25.43|-44.19|0.000
91611834|NCT01096667|183117671|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.42||||0|TWO_SIDED|80.0|-44.78|-26.07||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-26.07|-44.78|0.000
91611835|NCT01096667|183117671|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.61||||0.467|TWO_SIDED|80.0|-9.86|8.65||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||8.65|-9.86|0.467
91611836|NCT01096667|183117672|SUPERIORITY_OR_OTHER||Difference in least squares means|-5.54||||0.224|TWO_SIDED|80.0|-14.89|3.82||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||3.82|-14.89|0.224
91611837|NCT01096667|183117672|SUPERIORITY_OR_OTHER||Difference in least squares means|-17.0||||0.011|TWO_SIDED|80.0|-26.39|-7.61||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-7.61|-26.39|0.011
91611838|NCT01096667|183117672|SUPERIORITY_OR_OTHER||Difference in least squares means|-26.59||||0|TWO_SIDED|80.0|-35.84|-17.33||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-17.33|-35.84|0.000
91611839|NCT01096667|183117672|SUPERIORITY_OR_OTHER||Difference in least squares means|8.65||||0.886|TWO_SIDED|80.0|-0.56|17.87||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||17.87|-0.56|0.886
91611840|NCT01845077|183117679|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|95.3|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|95.3|
91611841|NCT01845077|183117679|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|101.5|||||TWO_SIDED|90.0|98.4|104.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment.||104.7|98.4|
91611842|NCT01845077|183117679|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|100.9|||||TWO_SIDED|90.0|98.2|103.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.7|98.2|
91611843|NCT01845077|183117680|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|94.9|||||TWO_SIDED|90.0|86.8|103.6|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.6|86.8|
91611844|NCT01845077|183117680|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|90.2|103.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.8|90.2|
91611845|NCT01845077|183117680|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|108.6||||||90.0|99.5|118.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||118.5|99.5|
91654566|NCT04684524|183201554|SUPERIORITY||LS Mean Difference|-5.45|||<|0.0001|TWO_SIDED|95.0|-7.48|-3.43|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-3.43|-7.48|<0.0001
91654567|NCT04684524|183201555|SUPERIORITY||LS Mean Difference|-2.18|||<|0.0001|TWO_SIDED|95.0|-3.04|-1.32|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-1.32|-3.04|<0.0001
91789332|NCT02650921|183458641|SUPERIORITY||Difference in Responder Rate|45.8|||<|0.0001|TWO_SIDED|95.0|32.3|59.3|||McNemar|||||59.3|32.3|<0.0001
91654568|NCT04684524|183201556|SUPERIORITY||LS Mean Difference|4.46||||0.0392|TWO_SIDED|95.0|0.22|8.71|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||8.71|0.22|0.0392
91611846|NCT01845077|183117681|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.7|||||TWO_SIDED|90.0|97.1|110.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||110.8|97.1|
91611847|NCT01845077|183117681|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|105.3|||||TWO_SIDED|90.0|99.9|111.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||111.0|99.9|
91611848|NCT01845077|183117681|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|90.2|104.1|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||104.1|90.2|
91611849|NCT01845077|183117682|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|86.8|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.8|
91611850|NCT01845077|183117682|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.7|||||TWO_SIDED|90.0|96.1|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|96.1|
91611851|NCT01845077|183117682|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|95.9|||||TWO_SIDED|90.0|86.7|106.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||106.0|86.7|
91611852|NCT01845077|183117683|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|86.6|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.6|
91611853|NCT01845077|183117683|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.4|||||TWO_SIDED|90.0|95.6|103.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.4|95.6|
91791186|NCT03123185|183460136|OTHER||Slope|0.7553|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|0.5736|0.937|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9370|0.5736|
91791187|NCT03123185|183460137|OTHER||Slope|0.4651|STANDARD_ERROR_OF_MEAN|0.1274|||TWO_SIDED|95.0|0.1935|0.7368|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.7368|0.1935|
91611854|NCT01845077|183117683|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|90.1|109.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.5|90.1|
91611855|NCT01845077|183117684|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.5|||||TWO_SIDED|90.0|84.8|109.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.8|84.8|
91791188|NCT03123185|183460137|OTHER||Slope|0.6651|STANDARD_ERROR_OF_MEAN|0.1385|||TWO_SIDED|95.0|0.3679|0.9622|||Power model||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9622|0.3679|
91791189|NCT03702244|183460140|SUPERIORITY|Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.|Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41|||Log Rank||Hazard ratio was adjusted for age, sex, and coronary artery disease equivalent (diabetes, history of peripheral artery disease or cerebrovascular disease), and intended first test strata (invasive or noninvasive).|Sample size and power calculations for this study are based on the hypothesis that the precision evaluation arm is superior to the usual care arm on the time-to-first event of the composite 3-component endpoint: all-cause death, non-fatal MI, or invasive cardiac catheterization without obstructive CAD over a 12-month of follow-up. Time to event analysis will use the date of the event, including the date of catheterization at which the absence of obstructive CAD is demonstrated.||0.41|0.20|<.001
91791190|NCT04369924|183460153|SUPERIORITY||F test for time by condition interaction|1.49||||0.25|TWO_SIDED||||||ANOVA|||||||.25
91791191|NCT04369924|183460154|SUPERIORITY||F test for time by condition interaction|2.8||||0.12|TWO_SIDED||||||ANOVA|||||||.12
91791192|NCT04369924|183460155|SUPERIORITY||F test for time by condition interaction|0.7||||0.7|TWO_SIDED||||||ANOVA|||||||.70
91654569|NCT04684524|183201557|SUPERIORITY||LS Mean Difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.49|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-0.49|-1.29|<0.0001
91654570|NCT04684524|183201558|SUPERIORITY||LS Mean Difference|-2.77|||<|0.0001|TWO_SIDED|95.0|-3.82|-1.72|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-1.72|-3.82|<0.0001
91654571|NCT04684524|183201559|SUPERIORITY||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.77|-1.02|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-1.02|-1.77|<0.0001
91654572|NCT04684524|183201560|SUPERIORITY||LS Mean Difference|-17.3||||0.0004|TWO_SIDED|95.0|-26.86|-7.74|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-7.74|-26.86|0.0004
91654573|NCT04684524|183201561|SUPERIORITY||LS Mean Difference|-36.31|||<|0.0001|TWO_SIDED|95.0|-45.59|-27.03|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-27.03|-45.59|<0.0001
91654574|NCT04684524|183201562|SUPERIORITY||Risk Difference (RD)|-29.1||||0.001|TWO_SIDED|95.0|-46.42|-11.79|||Mantel Haenszel|||Risk difference was estimated using Mantel-Haenszel estimate and confidence limits, with Mantel-Haenszel stratum weights for time from last surgery (\<=2 years, \>2 years) and region (Americas and Asia) and the Sato variance estimator.||-11.79|-46.42|0.0010
91654575|NCT04684524|183201563|SUPERIORITY||LS Mean Difference|-15.11||||0.0032|TWO_SIDED|95.0|-25.15|-5.07|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-5.07|-25.15|0.0032
91654576|NCT04684524|183201564|SUPERIORITY||LS Mean Difference|-80.72|||<|0.0001|TWO_SIDED|95.0|-112.82|-48.61|||ANCOVA|||Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, time from last surgery (\<=2 years, \>2 years), and region (Americas and Asia) as covariates.||-48.61|-112.82|<0.0001
91654577|NCT03466411|183201598|SUPERIORITY||Least Square (LS) Mean Difference|124.2|||<|0.001|TWO_SIDED|95.0|89.8|158.7|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||158.7|89.8|<0.001
91789333|NCT01087788|183458667|SUPERIORITY_OR_OTHER||Difference in Percentages|33.7|||<|0.001|TWO_SIDED|95.0|22.8|44.6||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||44.6|22.8|<0.001
91791193|NCT04369924|183460156|SUPERIORITY||F test for time by condition interaction|3.67||||0.07|TWO_SIDED||||||ANOVA|||||||.07
91654578|NCT03466411|183201598|SUPERIORITY||LS Mean Difference|102.7|||<|0.001|TWO_SIDED|95.0|68.5|136.9|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||136.9|68.5|<0.001
91654579|NCT03466411|183201598|SUPERIORITY||LS Mean Difference|108.7|||<|0.001|TWO_SIDED|95.0|73.9|143.5|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||143.5|73.9|<0.001
91791194|NCT04369924|183460157|SUPERIORITY||Slope|0.16||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||.82
91791195|NCT04369924|183460158|SUPERIORITY||Slope|-2.41||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||.59
91654580|NCT03466411|183201599|SUPERIORITY||Adjusted treatment difference|38.1|||<|0.001|TWO_SIDED|95.0|27.3|48.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||48.9|27.3|<0.001
91654581|NCT03466411|183201599|SUPERIORITY||Adjusted treatment difference|42.8|||<|0.001|TWO_SIDED|95.0|31.6|53.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||53.9|31.6|<0.001
91654582|NCT03466411|183201600|SUPERIORITY||Adjusted treatment difference|33.7|||<|0.001|TWO_SIDED|95.0|24.1|43.2|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||43.2|24.1|<0.001
91654583|NCT03466411|183201600|SUPERIORITY||Adjusted treatment difference|32.9|||<|0.001|TWO_SIDED|95.0|23.5|42.4|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||42.4|23.5|<0.001
91654584|NCT03466411|183201601|SUPERIORITY||Adjusted treatment difference|34.2|||<|0.001|TWO_SIDED|95.0|23.2|45.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||45.3|23.2|<0.001
91654585|NCT03466411|183201601|SUPERIORITY||Adjusted treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|23.5|46.5|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||46.5|23.5|<0.001
91611856|NCT01845077|183117684|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.2|||||TWO_SIDED|90.0|98.9|107.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||107.7|98.9|
91611857|NCT01845077|183117684|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|107.7|||||TWO_SIDED|90.0|92.5|125.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||125.4|92.5|
91611858|NCT01004107|183117685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91611859|NCT01004107|183117686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91611860|NCT01004107|183117687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91611861|NCT01004107|183117688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91611862|NCT01004107|183117691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91611863|NCT01004107|183117692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91611864|NCT03425656|183117741|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.|Mean Difference (Net)|-0.03||||0.73|TWO_SIDED|95.0|-0.23|0.16|||Chi-squared|||||0.16|-0.23|0.73
91611865|NCT03425656|183117742|OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
91611866|NCT03425656|183117743|OTHER||Chi-squared|0.42||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
91611867|NCT03425656|183117744|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.||||||0.59|||||||Chi-squared|||||||0.59
91611868|NCT00377299|183117746|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||0.05
91611869|NCT00377299|183117747|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
91611870|NCT00377299|183117748|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
91611871|NCT00377299|183117749|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
91611872|NCT00377299|183117750|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
91611873|NCT02209597|183117752|SUPERIORITY||||||<|0.05|ONE_SIDED|90.0|||||ANOVA|||||||<0.05
91611874|NCT04799782|183117766|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
91611875|NCT04799782|183117767|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
91611876|NCT02316470|183117786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91611877|NCT02316470|183117786|SUPERIORITY_OR_OTHER|||||||0.0261|||||||Cochran-Mantel-Haenszel|||||||0.0261
91611878|NCT02316470|183117786|SUPERIORITY_OR_OTHER|||||||0.0364|||||||Cochran-Mantel-Haenszel|||||||0.0364
91611879|NCT02316470|183117786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91611880|NCT02316470|183117786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91611881|NCT02316470|183117786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91611882|NCT02316470|183117786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91611883|NCT02316470|183117787|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
91611884|NCT02316470|183117788|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
91611885|NCT02316470|183117789|SUPERIORITY_OR_OTHER||||||<|0.0001||||||the p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
91611886|NCT02988986|183117839|SUPERIORITY|Based on prior data for Ki67 changes in the tamoxifen arm alone, we will assume null hypothesis and alternative hypotheses of 60% and 80% reduction in Ki67, respectively. A sample of 25 patients will provide 86% power to detect the hypothesized reduction in Ki67 with 5% alpha based on a two-sided, one sample t-test of mean percent change in Ki67 level.|||||=|0.0023|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was the change in Ki67 after 6 weeks of treatment.||||=0.0023
91611887|NCT00634543|183117848|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if lower confidence limit of 2-sided 95% CI was less than the non-inferiority margin of 1.39.|Mean Difference (Net)|0.39||||0.2143|TWO_SIDED|95.0|-0.23|1.01|||t-test, 2 sided|P-value was calculated for change from baseline in pain intensity score at Day 43.||||1.01|-0.23|0.2143
91611888|NCT00634543|183117849|SUPERIORITY_OR_OTHER|||||||0.7539|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 15.||||||0.7539
91611889|NCT00634543|183117849|SUPERIORITY_OR_OTHER|||||||0.5905|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 29.||||||0.5905
91611890|NCT00634543|183117849|SUPERIORITY_OR_OTHER|||||||0.7407|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 43.||||||0.7407
91611891|NCT00634543|183117850|SUPERIORITY_OR_OTHER|||||||0.3504|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.3504
91611892|NCT00634543|183117851|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.5690
91611893|NCT01650779|183117856|SUPERIORITY_OR_OTHER|||||||0.0002|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.0002
91611894|NCT01650779|183117856|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||<0.0001
91611895|NCT01650779|183117856|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||<0.0001
91611896|NCT01650779|183117857|SUPERIORITY_OR_OTHER|||||||0.1178|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.1178
91611897|NCT01650779|183117857|SUPERIORITY_OR_OTHER|||||||0.1176|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||0.1176
91611898|NCT01650779|183117857|SUPERIORITY_OR_OTHER|||||||0.0322|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||0.0322
91611899|NCT01650779|183117858|SUPERIORITY_OR_OTHER|||||||0.5811|||||||One sample test of median (sign test)|||Baseline versus Month 2: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.5811
91611900|NCT01650779|183117858|SUPERIORITY_OR_OTHER|||||||0.7744|||||||One sample test of median (sign test)|||Baseline versus Month 4: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.7744
91611901|NCT01650779|183117858|SUPERIORITY_OR_OTHER|||||||0.3877|||||||One sample test of median (sign test)|||Baseline versus Month 6: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.3877
91654586|NCT03466411|183201602|SUPERIORITY||Adjusted treatment difference|27.9|||<|0.001|TWO_SIDED|95.0|18.7|37.1|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||37.1|18.7|<0.001
91791196|NCT01653132|183460162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.194|STANDARD_DEVIATION|0.61|||TWO_SIDED|95.0|-0.71|0.32|||||negative values correspond to a reduction in saliva weight with Inco-A.|Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.||0.32|-0.71|
91791197|NCT01653132|183460163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.3|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|-50.8|6.2|||||negative numbers represent reduction in saliva weight with Inco-A|||6.2|-50.8|
91791198|NCT01653132|183460164|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33|STANDARD_DEVIATION|1.41|||TWO_SIDED|95.0|-1.16|0.69|||||negative values represent reduction in scores (improvement in drooling) with Inco-A|||0.69|-1.16|
91611902|NCT03567291|183117874|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.78|TWO_SIDED|95.0|-3.4|2.6|||ANCOVA|||||2.6|-3.4|0.78
91611903|NCT01103349|183117877|SUPERIORITY||Adjusted mean treatment differences|3.87|STANDARD_DEVIATION|1.494||0.005|TWO_SIDED|95.0|0.931|6.809||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||6.809|0.931|0.0050
91611904|NCT01103349|183117877|SUPERIORITY||Adjusted mean treatment differences|2.369|STANDARD_DEVIATION|1.567||0.0657||95.0|-0.713|5.452||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||5.452|-0.713|0.0657
91611905|NCT01103349|183117877|SUPERIORITY||Adjusted mean treatment differences|1.501|STANDARD_DEVIATION|1.602||0.1748|TWO_SIDED|95.0|-1.652|4.653||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd)||4.653|-1.652|0.1748
91611906|NCT01103349|183117878|SUPERIORITY||Adjusted mean treatment differences|-0.28|STANDARD_DEVIATION|0.118||0.0092|TWO_SIDED|95.0|-0.512|-0.048||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.048|-0.512|0.0092
91611907|NCT01103349|183117878|SUPERIORITY||Adjusted mean treatment differences|-0.18|STANDARD_DEVIATION|0.124||0.0732|TWO_SIDED|95.0|-0.423|0.063||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.063|-0.423|0.0732
91611908|NCT01103349|183117878|SUPERIORITY||Adjusted mean treatment differences|-0.1|STANDARD_DEVIATION|0.126||0.2139|TWO_SIDED|95.0|-0.347|0.147||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.147|-0.347|0.2139
91611909|NCT00283712|183117902|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-0.22|0.22|||Fisher Exact|||The study goals were to gather evidence of safety and possible efficacy of infliximab for treatment of pemphigus vulgaris (PV). The analyses focused on estimation rather than hypothesis testing; therefore, there was not sufficient power to detect plausible treatment differences unless they were very large. The sample size reflects a balance between the desire to meet study goals and to expose as few participants as possible until the safety of infliximab for treatment of PV has been clarified.||0.22|-0.22|1.00
91611910|NCT00283712|183117902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|90.0|0.02|42.67|||Fisher Exact|||||42.67|0.02|1.00
91611911|NCT00283712|183117903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.06||||||||0.06|-0.26|
91611912|NCT00283712|183117904|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||1|TWO_SIDED|90.0|-0.31|0.36||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||0.36|-0.31|1.00
91791199|NCT01653132|183460165|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.333|||||TWO_SIDED|95.0|-0.633|0.071||||||||0.071|-0.633|
91791200|NCT01653132|183460166|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.11|||||TWO_SIDED|95.0|-0.46|0.28||||||||0.28|-0.46|
91791201|NCT03828370|183460167|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
91791202|NCT03828370|183460168|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||.034
91523917|NCT00708435|182923400|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in the decrease of INR (%)|52.6|||||TWO_SIDED|95.0|39.4|65.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with a rapid decrease of the INR.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.||65.9|39.4|
91523918|NCT04766086|182923414|OTHER||Risk difference|0.0||||||95.0|-3.8|3.7||||||||3.7|-3.8|
91523919|NCT04766086|182923415|OTHER||GMR|0.546|||||TWO_SIDED|95.0|0.405|0.736||||||GMR for Anti-PT Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.736|0.405|
91523920|NCT04766086|182923415|OTHER||GMR|0.567|||||TWO_SIDED|95.0|0.455|0.707||||||GMR for Anti-FHA Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.707|0.455|
91523921|NCT04766086|182923415|OTHER||GMR|0.588|||||TWO_SIDED|95.0|0.451|0.766||||||GMR for Anti-PRN Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.766|0.451|
91523922|NCT04766086|182923416|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.38|2.089||||||GMR for serotype Ia: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.089|0.380|
91523923|NCT04766086|182923416|OTHER||GMR|1.149|||||TWO_SIDED|95.0|0.455|2.901||||||GMR for serotype Ib: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.901|0.455|
91523924|NCT04766086|182923416|OTHER||GMR|1.032||||||95.0|0.551|1.931||||||GMR for serotype II: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.931|0.551|
91523925|NCT04766086|182923416|OTHER||GMR|0.635|||||TWO_SIDED|95.0|0.303|1.329||||||GMR for serotype III: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.329|0.303|
91523926|NCT04766086|182923416|OTHER||GMR|1.474|||||TWO_SIDED|95.0|0.842|2.58||||||GMR for serotype IV: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.580|0.842|
91523927|NCT04766086|182923416|OTHER||GMR|0.559|||||TWO_SIDED|95.0|0.232|1.349||||||GMR for serotype V: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.349|0.232|
91523928|NCT01674621|182923440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0066||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0066
91523929|NCT01674621|182923440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0005
91523930|NCT01674621|182923440|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||<0.0001
91523931|NCT01674621|182923440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.93|||||TWO_SIDED|95.0|-5.555|-2.305|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-2.305|-5.555|
91523932|NCT01674621|182923440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.47|||||TWO_SIDED|95.0|-5.104|-1.837|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.837|-5.104|
91523933|NCT01674621|182923440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.856|||||TWO_SIDED|95.0|-4.519|-1.193|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.193|-4.519|
91654587|NCT03466411|183201602|SUPERIORITY||Adjusted treatment difference|30.8|||<|0.001|TWO_SIDED|95.0|21.3|40.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||40.3|21.3|<0.001
91791203|NCT00046891|183460179|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.||||0.84
91791204|NCT01431300|183460208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.0|STANDARD_DEVIATION|12.0|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
91791205|NCT01431300|183460208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|19.0|<|0.01||95.0|||||t-test, 2 sided|||contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
91791206|NCT06054269|183460216|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.004
91791207|NCT06054269|183460216|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.066
91791208|NCT06054269|183460216|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.694
91791209|NCT06054269|183460216|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.408
91791210|NCT06054269|183460217|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.164
91791211|NCT06054269|183460217|SUPERIORITY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.113
91791212|NCT06054269|183460217|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.404
91791213|NCT06054269|183460217|SUPERIORITY|||||||0.879|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.879
91791214|NCT06054269|183460218|SUPERIORITY||||||<|0.001|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||<0.001
91791215|NCT06054269|183460218|SUPERIORITY|||||||0.002|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.002
91791216|NCT06054269|183460218|SUPERIORITY|||||||0.468|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.468
91791217|NCT06054269|183460218|SUPERIORITY|||||||0.057|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.057
91791218|NCT06054269|183460219|SUPERIORITY|||||||0.112|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.112
91791219|NCT06054269|183460219|SUPERIORITY|||||||0.149|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.149
91791220|NCT06054269|183460219|SUPERIORITY|||||||0.101|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.101
91791221|NCT06054269|183460219|SUPERIORITY|||||||0.259|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.259
91791222|NCT06054269|183460220|SUPERIORITY|||||||0.097|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.097
91791223|NCT06054269|183460220|SUPERIORITY|||||||0.733|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.733
91791224|NCT06054269|183460220|SUPERIORITY|||||||0.477|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.477
91791225|NCT06054269|183460220|SUPERIORITY|||||||0.312|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.312
91791226|NCT06054269|183460221|SUPERIORITY|||||||0.22|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.220
91791227|NCT06054269|183460221|SUPERIORITY|||||||0.003|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.003
91791228|NCT06054269|183460221|SUPERIORITY|||||||0.897|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.897
91791229|NCT06054269|183460221|SUPERIORITY|||||||0.931|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.931
91791230|NCT01738477|183460222|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to diphtheria.||9.95|-3.25|
91523934|NCT01674621|182923441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0547
91654588|NCT03466411|183201603|SUPERIORITY||Adjusted treatment difference|25.1|||<|0.001|TWO_SIDED|95.0|14.1|36.2|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.2|14.1|<0.001
91791231|NCT01738477|183460222|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to tetanus.||9.95|-3.25|
91523935|NCT01674621|182923441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0056
91523936|NCT01674621|182923441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0018
91523937|NCT01674621|182923441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|||||TWO_SIDED|95.0|-2.864|-0.672|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-0.672|-2.864|
91523938|NCT01674621|182923441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.42|||||TWO_SIDED|95.0|-2.522|-0.318|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.318|-2.522|
91523939|NCT01674621|182923441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.247|||||TWO_SIDED|95.0|-2.368|-0.126|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.126|-2.368|
91523940|NCT01674621|182923442|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9493||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9493
91523941|NCT01674621|182923442|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9806||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9806
91523942|NCT01674621|182923442|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5191||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.5191
91523943|NCT01674621|182923442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.168|1.04|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.040|-2.168|
91523944|NCT01674621|182923442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.483|||||TWO_SIDED|95.0|-2.115|1.15|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.150|-2.115|
91523945|NCT01674621|182923442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-1.106|2.139|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||2.139|-1.106|
91523946|NCT01674621|182923443|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2549||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2549
91523947|NCT01674621|182923443|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9115||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9115
91523948|NCT01674621|182923443|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2390
91523949|NCT01674621|182923443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.146|||||TWO_SIDED|95.0|-40.501|-3.79|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-3.790|-40.501|
91523950|NCT01674621|182923443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.086|||||TWO_SIDED|95.0|-30.543|6.372|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||6.372|-30.543|
91523951|NCT01674621|182923443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.828|||||TWO_SIDED|95.0|-41.614|-4.041|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-4.041|-41.614|
91523952|NCT01674621|182923444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1632
91523953|NCT01674621|182923444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9834
91523954|NCT01674621|182923444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2179||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.||||||0.2179
91523955|NCT01674621|182923444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.541|||||TWO_SIDED|95.0|-48.557|-6.525|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-6.525|-48.557|
91710440|NCT01151345|183313552|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|91.26|||||TWO_SIDED|90.0|83.83|99.34||||||Natural-log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||99.34|83.83|
91523956|NCT01674621|182923444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.702|||||TWO_SIDED|95.0|-39.835|2.43|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||2.430|-39.835|
91611913|NCT00283712|183117904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||1|TWO_SIDED|90.0|0.02|38.35||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||38.35|0.02|1.00
91611914|NCT00283712|183117905|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.65|TWO_SIDED|90.0|-0.15|0.55|||Fisher Exact|||||0.55|-0.15|0.65
91611915|NCT00283712|183117905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.65|TWO_SIDED|90.0|0.06|2.79|||Fisher Exact|||||2.79|0.06|0.650
91611916|NCT00283712|183117915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.3|0.3|||Fisher Exact|||||0.3|-0.3|1.00
91611917|NCT00090285|183117919|SUPERIORITY_OR_OTHER||Risk Difference (RD)|90.6||||||95.0|70.1|98.2|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.|||98.2|70.1|
91611918|NCT00090285|183117927|SUPERIORITY_OR_OTHER||Risk Difference (RD)|77.5||||||95.0|39.6|93.3||||||||93.3|39.6|
91611919|NCT00090285|183117928|SUPERIORITY_OR_OTHER||Risk Difference (RD)|85.5||||||95.0|77.0|91.3|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||91.3|77.0|
91611920|NCT00090285|183117929|SUPERIORITY_OR_OTHER||Risk Difference (RD)|51.0||||||95.0|40.3|59.9|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||59.9|40.3|
91611921|NCT02747043|183117958|EQUIVALENCE|Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.|Risk Difference (RD)|7.7|||||TWO_SIDED|90.0|-1.4|16.8|||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).|||16.8|-1.4|
91611922|NCT02747043|183117958|OTHER||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|-3.2|18.6||||||||18.6|-3.2|
91611923|NCT02747043|183117959|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|90.0|-9.3|11.2||||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||11.2|-9.3|
91611924|NCT02747043|183117959|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-11.3|13.2||||||The 2-sided 95% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||13.2|-11.3|
91611925|NCT02747043|183117965|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-8.3|16.3||||||Percentage risk difference for 'Any adverse event of interest'||16.3|-8.3|
91611926|NCT02747043|183117965|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-12.1|12.3||||||Percentage risk difference for 'Infusion reactions including hypersensitivity'||12.3|-12.1|
91611927|NCT02747043|183117965|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-11.8|13.0||||||Percentage risk difference for 'Hematological reactions'||13.0|-11.8|
91611928|NCT02747043|183117965|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.8|13.2||||||Percentage risk difference in 'Cardiac disorders'||13.2|-11.8|
91611929|NCT02747043|183117965|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-10.9|14.0||||||Percentage risk difference in 'Serious infections'||14.0|-10.9|
91611930|NCT02747043|183117965|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.7|13.2||||||Percentage risk difference in 'Severe mucocutaneous reactions'||13.2|-11.7|
91611931|NCT01591018|183117974|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.|Chi-squared, Corrected|||Sample size was based on an expected 20% reduction of new ischemic lesions on DW-MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).||||<0.05
91611932|NCT02238028|183117984|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Paired t-test,2 sided|||Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.||||<0.05
91611933|NCT02238028|183117985|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test,2 sided|||||||<0.05
91611934|NCT00631488|183117995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9||||0.002|TWO_SIDED|95.0|5.2|22.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval (CI) for the between group difference.||22.7|5.2|0.002
91611935|NCT00631488|183117995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-26.5|-9.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-9.2|-26.5|<0.001
91611936|NCT00631488|183117996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||18.2|0.0|0.050
91611937|NCT00631488|183117996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-28.0|-10.1|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-10.1|-28.0|<0.001
91611938|NCT00631488|183117997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||45.8|-0.6|0.056
91611939|NCT00631488|183117997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.6|||<|0.001|TWO_SIDED|95.0|-67.3|-21.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-21.8|-67.3|<0.001
91611940|NCT00631488|183117998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.001|TWO_SIDED|95.0|1.7|6.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||6.7|1.7|0.001
91611941|NCT00631488|183117998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||<|0.001|TWO_SIDED|95.0|10.7|15.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||15.7|10.7|<0.001
91611942|NCT00631488|183117999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.5|-3.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference||-3.8|-9.5|<0.001
91611943|NCT00631488|183117999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.001|TWO_SIDED|95.0|-14.1|-8.5|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||-8.5|-14.1|<0.001
91611944|NCT00103194|183118000|SUPERIORITY_OR_OTHER||PSA response rate|0.0|||||TWO_SIDED|90.0|0.0|8.2||||||||8.2|0|
91611945|NCT00103194|183118001|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.||||||0.006
91654589|NCT03466411|183201604|SUPERIORITY||Adjusted treatment difference|27.7|||<|0.001|TWO_SIDED|95.0|19.3|36.1|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.1|19.3|<0.001
91654590|NCT03466411|183201605|SUPERIORITY||Adjusted treatment difference|31.2|||<|0.001|TWO_SIDED|95.0|21.1|41.3|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||41.3|21.1|<0.001
91523957|NCT01674621|182923444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.914|||||TWO_SIDED|95.0|-48.424|-5.405|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-5.405|-48.424|
91611946|NCT03136705|183118004|SUPERIORITY||trend analysis|1.009||||0.3738|TWO_SIDED|95.0|0.989|1.031|||Mixed Models Analysis|||linear mixed model for repeated measures data||1.031|0.989|0.3738
91611947|NCT03136705|183118005|SUPERIORITY||trend analysis|0.0043||||0.854|TWO_SIDED|95.0|-0.0414|0.0499|||Mixed Models Analysis|||linear mixed model for repeated measures data||0.0499|-0.0414|0.854
91611948|NCT03136705|183118006|SUPERIORITY||trend analysis|20.38||||0.0648|TWO_SIDED|95.0|-1.26|42.03|||Mixed Models Analysis|||linear mixed model for repeated measures data||42.03|-1.26|0.0648
91611949|NCT02927171|183118052|OTHER|||||||0.17|||||||t-test, 1 sided|||||||0.17
91611950|NCT01703819|183118100|SUPERIORITY_OR_OTHER|||||||0.7726||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.7726
91611951|NCT01703819|183118101|SUPERIORITY_OR_OTHER|||||||0.5702||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.||||0.5702
91611952|NCT02285010|183118285|NON_INFERIORITY|Definition: 50% reduction of morphine consumption Type I error (alpha) 0.05, Type II error (beta) 80%||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91611953|NCT02285010|183118286|NON_INFERIORITY|Alpha 0.05, Beta 80%||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
91611954|NCT02285010|183118287|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.33|||||||Wilcoxon (Mann-Whitney)|||for NRS at rest||||0.33
91611955|NCT02285010|183118287|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.75|||||||Wilcoxon (Mann-Whitney)|||for NRS at movement||||0.75
91611956|NCT02285010|183118288|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.16|||||||Chi-squared|||For pruritus||||0.16
91611957|NCT02285010|183118288|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.66|||||||Chi-squared|||For Nausea||||0.66
91611958|NCT02285010|183118288|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.46|||||||Chi-squared|||For Vomiting||||0.46
91611959|NCT02285010|183118288|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.54|||||||Chi-squared|||For Dizziness||||0.54
91611960|NCT02285010|183118288|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05|||||||Chi-squared|||For visual disturbance||||0.05
91611961|NCT02285010|183118289|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05||||||P-Value 0.05 was calculated.|Chi-squared|||||||0.05
91611962|NCT01832961|183118290|OTHER||||||<|0.05|||||||Friedman's Test|Friedman's test followed by Dunn's multiple comparison||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).|||<0.05
91611963|NCT01832961|183118291|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
91611964|NCT01832961|183118292|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
91611965|NCT01832961|183118293|OTHER||||||<|0.05|||||||T-test|T-test was used to comparisons before and after FeNO results||||||<0.05
91611966|NCT01832961|183118294|OTHER||||||<|0.05|||||||T-test|||||||<0.05
91611967|NCT01164501|183118316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.62|-0.39||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.39|-0.62|<0.0001
91611968|NCT01164501|183118317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.32||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.32|-0.72|<0.0001
91654591|NCT03466411|183201606|SUPERIORITY||Adjusted treatment difference|22.1|||<|0.001|TWO_SIDED|95.0|12.2|31.9|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||31.9|12.2|<0.001
91523958|NCT01674621|182923445|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||1.0000
91611969|NCT01164501|183118317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.49||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.49|-0.88|<0.0001
91611970|NCT01164501|183118318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.28|-0.56|<0.0001
91611971|NCT02179398|183118339|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
91611972|NCT02179398|183118340|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
91611973|NCT02179398|183118341|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|95.0|||||Chi-squared|||Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription rate||||0.810
91611974|NCT02160977|183118445|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91611975|NCT02160977|183118446|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91611976|NCT02160977|183118447|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91611977|NCT02975349|183118448|SUPERIORITY||Lesion rate ratio|1.45||||0.2947|TWO_SIDED|95.0|0.72|2.91|||Negative Binomial model|||||2.91|0.72|0.2947
91611978|NCT02975349|183118448|SUPERIORITY||Lesion rate ratio|0.3||||0.0015|TWO_SIDED|95.0|0.14|0.63|||Negative Binomial model|||||0.63|0.14|0.0015
91611979|NCT02975349|183118448|SUPERIORITY||Lesion rate ratio|0.44||||0.0313|TWO_SIDED|95.0|0.21|0.93|||Negative Binomial model|||||0.93|0.21|0.0313
91611980|NCT02975349|183118449|SUPERIORITY||Qualified relapse rate ratio|1.66||||0.2692|TWO_SIDED|95.0|0.67|4.09|||Negative Binomial model|||||4.09|0.67|0.2692
91611981|NCT02975349|183118449|SUPERIORITY||Qualified relapse rate ratio|0.31||||0.0896|TWO_SIDED|95.0|0.08|1.2|||Negative Binomial model|||||1.20|0.08|0.0896
91611982|NCT02975349|183118449|SUPERIORITY||Qualified relapse rate ratio|0.23||||0.0633|TWO_SIDED|95.0|0.05|1.09|||Negative Binomial model|||||1.09|0.05|0.0633
91611983|NCT02975349|183118450|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5609|TWO_SIDED|95.0|0.29|1.95|||Logistic model|||||1.95|0.29|0.5609
91611984|NCT02975349|183118450|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0689|TWO_SIDED|95.0|0.92|8.41|||Logistic model|||||8.41|0.92|0.0689
91611985|NCT02975349|183118450|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1767|TWO_SIDED|95.0|0.72|5.99|||Logistic model|||||5.99|0.72|0.1767
91611986|NCT02975349|183118451|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.407|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.4070
91611987|NCT02975349|183118451|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.5829|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.5829
91611988|NCT02975349|183118451|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.2732|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.2732
91611989|NCT02975349|183118463|SUPERIORITY||Lesion rate ratio|1.36||||0.3676|TWO_SIDED|95.0|0.7|2.65|||Negative Binomial|||||2.65|0.70|0.3676
91654592|NCT03462719|183201637|SUPERIORITY||Hazard Ratio (HR)|0.216|||<|0.0001|TWO_SIDED|95.0|0.131|0.357|||Log Rank|||||0.357|0.131|<0.0001
91611990|NCT02975349|183118463|SUPERIORITY||Lesion rate ratio|0.27||||0.0005|TWO_SIDED|95.0|0.13|0.57|||Negative Binomial|||||0.57|0.13|0.0005
91611991|NCT02975349|183118463|SUPERIORITY||Lesion rate ratio|0.41||||0.0157|TWO_SIDED|95.0|0.2|0.85|||Negative Binomial|||||0.85|0.20|0.0157
91611992|NCT02975349|183118464|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9731|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon rank-sum test|||||0.25|-0.25|0.9731
91611993|NCT02975349|183118464|SUPERIORITY||Hodges-Lehmann estimate|-0.25||||0.0017|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank-sum test|||||0.00|-0.50|0.0017
91611994|NCT02975349|183118464|SUPERIORITY||Hodges-Lehmann estimate|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.25|||Wilcoxon rank-sum test|||||-0.25|-0.75|< 0.0001
91611995|NCT02975349|183118465|SUPERIORITY||Lesion Rate ratio|1.29||||0.4807|TWO_SIDED|95.0|0.63|2.65|||Negative Binomial|||||2.65|0.63|0.4807
91611996|NCT02975349|183118465|SUPERIORITY||Lesion Rate ratio|0.5||||0.062|TWO_SIDED|95.0|0.24|1.04|||Negative Binomial|||||1.04|0.24|0.0620
91611997|NCT02975349|183118465|SUPERIORITY||Lesion Rate ratio|0.42||||0.0189|TWO_SIDED|95.0|0.2|0.87|||Negative Binomial|||||0.87|0.20|0.0189
91611998|NCT02975349|183118466|SUPERIORITY||Difference in least squares means|0.02||||0.8776|TWO_SIDED|95.0|-0.24|0.28|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||0.28|-0.24|0.8776
91611999|NCT02975349|183118466|SUPERIORITY||Difference in least squares means|-0.41||||0.0019|TWO_SIDED|95.0|-0.66|-0.15|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.15|-0.66|0.0019
91612000|NCT02975349|183118466|SUPERIORITY||Difference in least squares means|-0.36||||0.0063|TWO_SIDED|95.0|-0.62|-0.1|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.10|-0.62|0.0063
91612001|NCT02975349|183118467|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9315|TWO_SIDED|95.0|-0.004|0.009|||Wilcoxon rank-sum test|||||0.009|-0.004|0.9315
91612002|NCT02975349|183118467|SUPERIORITY||Hodges-Lehmann estimate|-0.014||||0.0008|TWO_SIDED|95.0|-0.05|0.0|||Wilcoxon rank-sum test|||||0.000|-0.050|0.0008
91612003|NCT02975349|183118467|SUPERIORITY||Hodges-Lehmann estimate|-0.018||||0.0014|TWO_SIDED|95.0|-0.042|0.0|||Wilcoxon rank-sum test|||||0.000|-0.042|0.0014
91612004|NCT03551522|183118486|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|11.02||||0.0874|TWO_SIDED|95.0|-1.63|23.67|||ANCOVA|||||23.67|-1.63|0.0874
91654593|NCT04799158|183201652|SUPERIORITY||Percentage difference|28.7|||<|0.0001|TWO_SIDED|95.0|21.84|35.55|||Fisher Exact|||||35.55|21.84|<0.0001
91654594|NCT04799158|183201652|SUPERIORITY||Percentage difference|33.3|||<|0.0001|TWO_SIDED|95.0|26.28|40.23|||Fisher Exact|||||40.23|26.28|<0.0001
91654595|NCT04799158|183201652|SUPERIORITY||Percentage difference|42.7|||<|0.0001|TWO_SIDED|95.0|35.92|49.42|||Fisher Exact|||||49.42|35.92|<0.0001
91789334|NCT01087788|183458667|SUPERIORITY_OR_OTHER||Difference in Percentages|27.6|||<|0.001|TWO_SIDED|95.0|16.5|38.7||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.7|16.5|<0.001
91612005|NCT03551522|183118486|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|6.54||||0.3151|TWO_SIDED|95.0|-6.28|19.37|||ANCOVA|||||19.37|-6.28|0.3151
91612006|NCT03551522|183118486|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|7.78||||0.2313|TWO_SIDED|95.0|-5.01|20.58|||ANCOVA|||||20.58|-5.01|0.2313
91612007|NCT05136885|183118495|SUPERIORITY||Disease Rate Ratio|0.87|STANDARD_DEVIATION|0.111|||TWO_SIDED|95.0|0.665|1.102||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. (Trehalose) slowed progression) was (0.8772). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by Trehalose relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, baseline use of Relyvrio, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, serum NfL concentration and random effects for regimen and participant-specific slopes.|1.102|0.665|
91654596|NCT04799158|183201653|SUPERIORITY||Percentage difference|30.3|||<|0.0001|TWO_SIDED|95.0|23.41|37.09|||Fisher Exact|||||37.09|23.41|<0.0001
91791232|NCT02720094|183460235|SUPERIORITY||A bias-adjusted hazard ratio|0.34||||0.0005|TWO_SIDED|95.0|0.18|0.62|||Regression, Cox||The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.|||0.62|0.18|0.0005
91791233|NCT02720094|183460235|SUPERIORITY||Hazard Ratio (HR)|0.328||||0.0005|TWO_SIDED|95.0|0.18|0.61|||Regression, Cox||The unadjusted hazard ratio is based on a Cox proportional hazards model stratified by region.|||0.61|0.18|0.0005
91791234|NCT02720094|183460237|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.45||The P-Values are two-sided.|Regression, Cox|||The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.||0.45|0.10|<0.001
91791235|NCT04876690|183460291|SUPERIORITY||||||=|0.1217|||||||t-test for Independent Samples|||PCS-12: Sex||||=0.1217
91791236|NCT04876690|183460291|SUPERIORITY||||||=|0.8241|||||||ANOVA|ANOVA=Analysis of variance||PCS-12: Employment Status||||=0.8241
91791237|NCT04876690|183460291|SUPERIORITY||||||=|0.3471|||||||ANOVA|||PCS-12: Smoking Status||||=0.3471
91791238|NCT04876690|183460291|SUPERIORITY||||||=|0.9951|||||||ANOVA|||PCS-12: Age at Onset||||=0.9951
91791239|NCT04876690|183460291|SUPERIORITY||||||=|0.0631|||||||ANOVA|||PCS-12: Disease Location||||=0.0631
91791240|NCT04876690|183460291|SUPERIORITY||||||=|0.7473|||||||ANOVA|||PCS-12: Disease Behavior||||=0.7473
91791241|NCT04876690|183460291|SUPERIORITY||||||=|0.4422|||||||t-test for Independent Samples|||PCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.4422
91791242|NCT04876690|183460291|SUPERIORITY||||||=|0.1796|||||||t-test for Independent Samples|||PCS-12: Fistula With High Intersphincteric Type||||=0.1796
91791243|NCT04876690|183460291|SUPERIORITY||||||=|0.3535|||||||t-test for Independent Samples|||PCS-12: Fistula With High Transsphincteric Type||||=0.3535
91791244|NCT04876690|183460291|SUPERIORITY||||||=|0.1508|||||||t-test for Independent Samples|||PCS-12: Fistula With Suprasphincteric Type||||=0.1508
91791245|NCT04876690|183460291|SUPERIORITY||||||=|0.2671|||||||t-test for Independent Samples|||PCS-12: Fistula with Extrasphincteric Type||||=0.2671
91791246|NCT04876690|183460291|SUPERIORITY||||||=|0.0594|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Intersphincteric Type||||=0.0594
91791247|NCT04876690|183460291|SUPERIORITY||||||=|0.5484|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Transsphincteric Type||||=0.5484
91791248|NCT04876690|183460291|SUPERIORITY||||||=|0.5387|||||||t-test for Independent Samples|||PCS-12: Fistula With Midline Position||||=0.5387
91791249|NCT04876690|183460291|SUPERIORITY||||||=|0.527|||||||t-test for Independent Samples|||PCS-12: Fistula With Lateral Position||||=0.5270
91791250|NCT04876690|183460291|SUPERIORITY||||||=|0.3863|||||||t-test for Independent Samples|||PCS-12: Fistula With Seton||||=0.3863
91791251|NCT04876690|183460291|SUPERIORITY||||||=|0.4206|||||||ANOVA|||PCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4206
91791252|NCT04876690|183460291|SUPERIORITY||||||=|0.0538|||||||t-test for Independent Samples|||PCS-12: Surgery-naïve||||=0.0538
91791253|NCT04876690|183460291|SUPERIORITY||||||=|0.9572|||||||t-test for Independent Samples|||PCS-12: Surgery - Fistulotomy||||=0.9572
91791254|NCT04876690|183460291|SUPERIORITY||||||=|0.4742|||||||t-test for Independent Samples|||PCS-12: Surgery - Loose Seton||||=0.4742
91791255|NCT04876690|183460291|SUPERIORITY||||||=|0.5735|||||||t-test for Independent Samples|||PCS-12: Surgery - Other||||=0.5735
91791256|NCT04876690|183460291|SUPERIORITY||||||=|0.376|||||||t-test for Independent Samples|||PCS-12: Presence of Perianal Abscess||||=0.3760
91791257|NCT04876690|183460292|SUPERIORITY||||||=|0.4814|||||||t-test for Independent Samples|||MCS-12: Sex||||=0.4814
91791258|NCT04876690|183460292|SUPERIORITY||||||=|0.3136|||||||Kruskal-Wallis|||MCS-12: Employment Status||||=0.3136
91791259|NCT04876690|183460292|SUPERIORITY||||||=|0.5808|||||||ANOVA|||MCS-12: Smoking Status||||=0.5808
91791260|NCT04876690|183460292|SUPERIORITY||||||=|0.2965|||||||ANOVA|||MCS-12: Age at Onset||||=0.2965
91791261|NCT04876690|183460292|SUPERIORITY||||||=|0.2874|||||||ANOVA|||MCS-12: Disease Location||||=0.2874
91654597|NCT04799158|183201653|SUPERIORITY||Percentage difference|23.9|||<|0.0001|TWO_SIDED|95.0|16.67|31.05|||Fisher Exact|||||31.05|16.67|<0.0001
91654598|NCT04799158|183201653|SUPERIORITY||Percentage difference|37.7|||<|0.0001|TWO_SIDED|95.0|31.0|44.35|||Fisher Exact|||||44.35|31.00|<0.0001
91654599|NCT04799158|183201654|SUPERIORITY|||||||0.1771|||||||Wilcoxon rank-sum test|||||||0.1771
91612008|NCT05136885|183118497|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.79||0.7607|TWO_SIDED|95.0|-4.06|2.97|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||2.97|-4.06|0.7607
91612009|NCT05136885|183118498|SUPERIORITY||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|3.204||0.7737|TWO_SIDED|95.0|-5.37|7.21|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||7.21|-5.37|0.7737
91612010|NCT05136885|183118499|SUPERIORITY|||||||0.2137|||||||Log Rank|||||||0.2137
91612011|NCT02026908|183118560|OTHER|Paired T- test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||A p-value was calculated. Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.0001
91612012|NCT02026908|183118561|OTHER|Paired t test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
91612013|NCT02026908|183118562|OTHER|Paired T test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
91612014|NCT02026908|183118563|OTHER|Paired T Test|p value|0.05||||0.0001|TWO_SIDED|||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided|||||||0.0001
91612015|NCT02026908|183118564|OTHER|Paired T test|p value|0.05||||0.008|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.008
91612016|NCT03270085|183118566|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91612017|NCT03270085|183118567|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
91612018|NCT03270085|183118568|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91612019|NCT03825042|183118569|SUPERIORITY||Mean Difference (Final Values)|-21.01||||0|TWO_SIDED|95.0|-26.8|-15.2|||ANCOVA|||||-15.20|-26.80|0.0000
91612020|NCT03825042|183118570|SUPERIORITY||Mean Difference (Final Values)|-6.08||||0|TWO_SIDED|95.0|-8.45|-3.61|||ANCOVA|||||-3.61|-8.45|0.0000
91612021|NCT03825042|183118571|SUPERIORITY||Mean Difference (Final Values)|-14.56||||0|TWO_SIDED|95.0|-20.02|-9.11|||ANCOVA|||||-9.11|-20.02|0.0000
91612022|NCT00521339|183118605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91612023|NCT00521339|183118606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
91612024|NCT00521339|183118607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
91612025|NCT00521339|183118608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91612026|NCT00521339|183118609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
91612027|NCT00521339|183118610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||||||0.242
91612028|NCT00521339|183118611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329|||||||Wilcoxon (Mann-Whitney)|||||||0.329
91612029|NCT00521339|183118612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.130
91612030|NCT00521339|183118614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
91612031|NCT00521339|183118615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
91612032|NCT00521339|183118616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91612033|NCT00521339|183118618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91612034|NCT00521339|183118619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
91612035|NCT00521339|183118620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
91654600|NCT04799158|183201654|SUPERIORITY|||||||0.1551|||||||Wilcoxon rank-sum test|||||||0.1551
91654601|NCT04799158|183201654|SUPERIORITY|||||||0.0094|||||||Wilcoxon rank-sum test|||||||0.0094
91654602|NCT04799158|183201655|SUPERIORITY|||||||0.3395|||||||Wilcoxon rank-sum test|||||||0.3395
91654603|NCT04799158|183201655|SUPERIORITY|||||||0.4882|||||||Wilcoxon rank-sum test|||||||0.4882
91654604|NCT04799158|183201655|SUPERIORITY|||||||0.0722|||||||Wilcoxon rank-sum test|||||||0.0722
91654605|NCT04799158|183201656|SUPERIORITY||Percentage difference|-3.9||||0.83|TWO_SIDED|95.0|-24.41|16.52|||Fisher Exact|||||16.52|-24.41|0.8300
91654606|NCT04799158|183201656|SUPERIORITY||Percentage difference|1.4|||>|0.9999|TWO_SIDED|95.0|-19.28|22.16|||Fisher Exact|||||22.16|-19.28|>0.9999
91654607|NCT04799158|183201656|SUPERIORITY||Percentage difference|2.3|||>|0.9999|TWO_SIDED|95.0|-18.22|22.88|||Fisher Exact|||||22.88|-18.22|>0.9999
91654608|NCT04799158|183201657|SUPERIORITY|||||||0.4684|||||||Wilcoxon rank-sum test|||||||0.4684
91654609|NCT04799158|183201657|SUPERIORITY|||||||0.656|||||||Wilcoxon rank-sum test|||||||0.6560
91654610|NCT04799158|183201657|SUPERIORITY|||||||0.6324|||||||Wilcoxon rank-sum test|||||||0.6324
91791262|NCT04876690|183460292|SUPERIORITY||||||=|0.4269|||||||ANOVA|||MCS-12: Disease Behavior||||=0.4269
91791263|NCT04876690|183460292|SUPERIORITY||||||=|0.8931|||||||t-test for Independent Samples|||MCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.8931
91791264|NCT04876690|183460292|SUPERIORITY||||||=|0.9384|||||||t-test for Independent Samples|||MCS-12: Fistula With High Intersphincteric Type||||=0.9384
91791265|NCT04876690|183460292|SUPERIORITY||||||=|0.8286|||||||Mann-Whitney|||MCS-12: Fistula With High Transsphincteric Type||||=0.8286
91791266|NCT04876690|183460292|SUPERIORITY||||||=|0.1919|||||||t-test for Independent Samples|||MCS-12: Fistula With Suprasphincteric Type||||=0.1919
91791267|NCT04876690|183460292|SUPERIORITY||||||=|0.6452|||||||t-test for Independent Samples|||MCS-12: Fistula with Extrasphincteric Type||||=0.6452
91791268|NCT04876690|183460292|SUPERIORITY||||||=|0.7218|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Intersphincteric Type||||=0.7218
91791269|NCT04876690|183460292|SUPERIORITY||||||=|0.9738|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Transsphincteric Type||||=0.9738
91791270|NCT04876690|183460292|SUPERIORITY||||||=|0.2419|||||||t-test for Independent Samples|||MCS-12: Fistula With Midline Position||||=0.2419
91791271|NCT04876690|183460292|SUPERIORITY||||||=|0.5524|||||||t-test for Independent Samples|||MCS-12: Fistula With Lateral Position||||=0.5524
91791272|NCT04876690|183460292|SUPERIORITY||||||=|0.4443|||||||t-test for Independent Samples|||MCS-12: Fistula With Seton||||=0.4443
91791273|NCT04876690|183460292|SUPERIORITY||||||=|0.4106|||||||ANOVA|||MCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4106
91791274|NCT04876690|183460292|SUPERIORITY||||||=|0.7795|||||||t-test for Independent Samples|||MCS-12: Surgery-naïve||||=0.7795
91791275|NCT04876690|183460292|SUPERIORITY||||||=|0.2964|||||||t-test for Independent Samples|||MCS-12: Surgery - Fistulotomy||||=0.2964
91791276|NCT04876690|183460292|SUPERIORITY||||||=|0.3287|||||||t-test for Independent Samples|||MCS-12: Surgery - Loose Seton||||=0.3287
91791277|NCT04876690|183460292|SUPERIORITY||||||=|0.0091|||||||t-test for Independent Samples|||MCS-12: Surgery - Other||||=0.0091
91791278|NCT04876690|183460292|SUPERIORITY||||||=|0.3889|||||||t-test for Independent Samples|||MCS-12: Presence of Perianal Abscess||||=0.3889
91791279|NCT04876690|183460293|SUPERIORITY||||||=|0.8001|||||||Pearson Correlation Coefficient|||PCS- 12: Age||||=0.8001
91791280|NCT04876690|183460293|SUPERIORITY||||||=|0.4532|||||||Pearson Correlation Coefficient|||PCS- 12: BMI||||=0.4532
91791281|NCT04876690|183460293|SUPERIORITY||||||=|0.9597|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.9597
91791282|NCT04876690|183460293|SUPERIORITY||||||=|0.3304|||||||Spearman Correlation Coefficient|||PCS- 12: Total Number of CPFs per Participant||||=0.3304
91791283|NCT04876690|183460293|SUPERIORITY||||||=|0.6333|||||||Pearson Correlation Coefficient|||PCS- 12: Time Since Seton Replacement||||=0.6333
91791284|NCT04876690|183460293|SUPERIORITY||||||=|0.8003|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.8003
91791285|NCT04876690|183460293|SUPERIORITY||||||=|0.0032|||||||Pearson Correlation Coefficient|||PCS- 12: PDAI Score||||=0.0032
91791286|NCT04876690|183460293|SUPERIORITY||||||=|0.0923|||||||Spearman Correlation Coefficient|||PCS- 12: Number of Internal Fistula Openings per Participant||||=0.0923
91791287|NCT04876690|183460293|SUPERIORITY||||||=|0.0994|||||||Spearman Correlation Coefficient|||PCS- 12: Number of External Fistula Openings per Participant||||=0.0994
91791288|NCT04876690|183460293|SUPERIORITY||||||=|0.0444|||||||Pearson Correlation Coefficient|||PCS- 12: SIBDQ Score||||=0.0444
91791289|NCT04876690|183460293|SUPERIORITY||||||=|0.086|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-M Score||||=0.0860
91791290|NCT04876690|183460293|SUPERIORITY||||||=|0.9415|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-F Score||||=0.9415
91791291|NCT04876690|183460293|SUPERIORITY||||||=|0.3709|||||||Pearson Correlation Coefficient|||PCS- 12: Wexner Score||||=0.3709
91791292|NCT04876690|183460294|SUPERIORITY||||||=|0.0674|||||||Pearson Correlation Coefficient|||MCS- 12: Age||||=0.0674
91791293|NCT04876690|183460294|SUPERIORITY||||||=|0.9392|||||||Pearson Correlation Coefficient|||MCS- 12: BMI||||=0.9392
91791294|NCT04876690|183460294|SUPERIORITY||||||=|0.6387|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.6387
91791295|NCT04876690|183460294|SUPERIORITY||||||=|0.7846|||||||Spearman Correlation Coefficient|||MCS- 12: Total Number of CPFs per Participant||||=0.7846
91791296|NCT04876690|183460294|SUPERIORITY||||||=|0.3972|||||||Pearson Correlation Coefficient|||MCS- 12: Time Since Seton Placement||||=0.3972
91791297|NCT04876690|183460294|SUPERIORITY||||||=|0.9496|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.9496
91791298|NCT04876690|183460294|SUPERIORITY||||||=|0.813|||||||Pearson Correlation Coefficient|||MCS- 12: PDAI Score||||=0.8130
91791299|NCT04876690|183460294|SUPERIORITY||||||=|0.4588|||||||Spearman Correlation Coefficient|||MCS- 12: Number of Internal Fistula Openings per Participant||||=0.4588
91791300|NCT04876690|183460294|SUPERIORITY||||||=|0.8663|||||||Spearman Correlation Coefficient|||MCS- 12: Number of External Fistula Openings per Participant||||=0.8663
91791301|NCT04876690|183460294|SUPERIORITY||||||=|0.1349|||||||Pearson Correlation Coefficient|||MCS- 12: SIBDQ Score||||=0.1349
91791302|NCT04876690|183460294|SUPERIORITY||||||=|0.5647|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-M Score||||=0.5647
91791303|NCT04876690|183460294|SUPERIORITY||||||=|0.9509|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-F Score||||=0.9509
91791304|NCT04876690|183460294|SUPERIORITY||||||=|0.5328|||||||Pearson Correlation Coefficient|||MCS- 12: Wexner Score||||=0.5328
91791305|NCT03400956|183460298|SUPERIORITY||Risk Difference (RD)|0.82|||<|0.0001|TWO_SIDED|95.0|0.72|0.93|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 63 (Vilaprisan) / 33 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.93|0.72|<.0001
91791306|NCT00492063|183460305|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.||3|-3|
91523959|NCT01674621|182923445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.1200
91612036|NCT00521339|183118621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
91612037|NCT00521339|183118622|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91612038|NCT00521339|183118623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
91612039|NCT00521339|183118624|SUPERIORITY_OR_OTHER_LEGACY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
91612040|NCT00521339|183118625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539|||||||Wilcoxon (Mann-Whitney)|||||||0.539
91612041|NCT00521339|183118626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
91612042|NCT00521339|183118627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
91612043|NCT00521339|183118628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||||||0.898
91612044|NCT00521339|183118629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
91612045|NCT01819935|183118643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2||||||Propensity Cox proportional hazards regression model was used.||1.20|0.72|
91612046|NCT01819935|183118644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.05||||||Propensity Cox proportional hazards regression model was used.||1.05|0.53|
91612047|NCT01819935|183118645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Propensity Cox proportional hazards regression model was used.||1.15|0.90|
91612048|NCT01819935|183118646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.39|1.09||||||Propensity Cox proportional hazards regression model was used.||1.09|0.39|
91612049|NCT01819935|183118647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.68|1.37||||||Propensity Cox proportional hazards regression model was used.||1.37|0.68|
91612050|NCT01819935|183118648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Propensity Cox proportional hazards regression model was used.||1.13|0.68|
91612051|NCT01819935|183118649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.48||||||Propensity Cox proportional hazards regression model was used.||1.48|0.54|
91612052|NCT01819935|183118650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.06|1.45||||||Propensity Cox proportional hazards regression model was used.||1.45|1.06|
91613565|NCT00257192|183121439|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.34|STANDARD_ERROR_OF_MEAN|1.19||0.2613|TWO_SIDED|95.0|-1.01|3.69||SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.|ANCOVA|Observed cases at Week 6.||Neurocognitive Index score at Week 6: difference from placebo||3.69|-1.01|0.2613
91523960|NCT01674621|182923445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9998||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.9998
91523961|NCT01674621|182923445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.906|||||TWO_SIDED|95.0|-96.926|-50.886|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-50.886|-96.926|
91523962|NCT01674621|182923445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-62.872|||||TWO_SIDED|95.0|-86.019|-39.725|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-39.725|-86.019|
91523963|NCT01674621|182923445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.367|||||TWO_SIDED|95.0|-96.927|-49.807|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.807|-96.927|
91523964|NCT01674621|182923446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8569||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.8569
91523965|NCT01674621|182923446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6091||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6091
91523966|NCT01674621|182923446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.||||||0.9999
91523967|NCT01674621|182923446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-110.398|||||TWO_SIDED|95.0|-156.966|-63.831|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-63.831|-156.966|
91612053|NCT04003155|183118651|SUPERIORITY||LSMean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.69|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)||-1.05|-2.69|<0.001
91523968|NCT01674621|182923446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-96.115|||||TWO_SIDED|95.0|-142.94|-49.29|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.290|-142.940|
91523969|NCT01674621|182923446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-104.418|||||TWO_SIDED|95.0|-152.079|-56.758|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-56.758|-152.079|
91523970|NCT01674621|182923447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3483||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.3483
91523971|NCT01674621|182923447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6839||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6839
91523972|NCT01674621|182923447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1067||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1067
91523973|NCT01674621|182923447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-43.721|||||TWO_SIDED|95.0|-75.748|-11.694|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-11.694|-75.748|
91523974|NCT01674621|182923447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.461|||||TWO_SIDED|95.0|-71.665|-7.257|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-7.257|-71.665|
91523975|NCT01674621|182923447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.334|||||TWO_SIDED|95.0|-82.113|-16.555|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-16.555|-82.113|
91523976|NCT01725386|182923458|SUPERIORITY_OR_OTHER|||||||0.895|||||||Log Rank (Mantel-Cox)|||||||0.895
91523977|NCT01216163|182923465|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|17.68|||<|0.001|TWO_SIDED|95.0|13.08|22.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference(Ibuprofen sodium - placebo) and 95 percent(%) confidence interval(CI):based on LS means from Analysis of Variance(ANOVA).Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:Ibuprofen sodium(IBU Na) versus(vs) Placebo(PBO), IBU Na vs Acetaminophen(APAP), APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||22.27|13.08|<0.001
91523978|NCT01216163|182923465|SUPERIORITY_OR_OTHER||LS mean difference|4.96||||0.01|TWO_SIDED|95.0|1.21|8.72||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium - Acetaminophen) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||8.72|1.21|0.010
91613566|NCT01905397|183121448|SUPERIORITY||Difference in proportions|0.05||||0.27|ONE_SIDED||||||t-test, 1 sided|||||||0.27
91612054|NCT04003155|183118651|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.89|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.25|-2.89|<0.001
91789335|NCT01087788|183458668|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-10.64|STANDARD_ERROR_OF_MEAN|8.35|=|0.203|TWO_SIDED|95.0|-27.05|5.77||Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors \& BL mTSS score as a covariate|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the pre-defined primary analysis.||5.77|-27.05|=0.203
91791307|NCT00492063|183460305|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.||2|-1|
91612055|NCT04003155|183118651|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
91612056|NCT04003155|183118651|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
91612057|NCT04003155|183118652|SUPERIORITY||LSMean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.44|<|0.001||95.0|-3.25|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.52|-3.25|<0.001
91612058|NCT04003155|183118652|SUPERIORITY||LSMean Difference|-2.55|STANDARD_ERROR_OF_MEAN|0.43|<|0.001||95.0|-3.4|-1.7||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.70|-3.40|<0.001
91612059|NCT04003155|183118652|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
91612060|NCT04003155|183118652|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
91612061|NCT04003155|183118653|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.012||95.0|-0.27|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.03|-0.27|0.012
91612062|NCT04003155|183118653|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.002||95.0|-0.3|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.07|-0.30|0.002
91612063|NCT04003155|183118653|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
91612064|NCT04003155|183118653|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
91612065|NCT04003155|183118654|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002||95.0|-0.39|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.09|-0.39|0.002
91612066|NCT04003155|183118654|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.007||95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.06|-0.35|0.007
91612067|NCT04003155|183118654|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
91612068|NCT04003155|183118654|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
91612069|NCT04003155|183118655|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.8||0.489||95.0|-2.0|1.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||1.0|-2.0|0.489
91612070|NCT04003155|183118655|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.155||95.0|-2.5|0.4||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.4|-2.5|0.155
91612071|NCT04003155|183118656|SUPERIORITY||LSMean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.53|-1.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-1.09|-2.53|<0.001
91612072|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-1.97|-0.53||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.53|-1.97|<0.001
91612073|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.75|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.19|-2.75|<0.001
91612074|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.6|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.05|-2.60|<0.001
91654611|NCT04799158|183201658|SUPERIORITY|||||||0.9896|||||||Wilcoxon rank-sum test|||||||0.9896
91523979|NCT01216163|182923465|SUPERIORITY_OR_OTHER||LS mean difference|12.71|||<|0.001|TWO_SIDED|95.0|8.12|17.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Acetaminophen - Placebo) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||17.30|8.12|<0.001
91654612|NCT04799158|183201658|SUPERIORITY|||||||0.6916|||||||Wilcoxon rank-sum test|||||||0.6916
91654613|NCT04799158|183201658|SUPERIORITY|||||||0.9316|||||||Wilcoxon rank-sum test|||||||0.9316
91654614|NCT00319956|183201659|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
91654615|NCT02607800|183201663|NON_INFERIORITY|Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than -5%. If the lower bound of the CI was greater than -5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.|Difference in proportions|-3.2|||||TWO_SIDED|95.0|-6.0|-0.4|||||Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||-0.4|-6.0|
91789336|NCT01087788|183458668|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.09|=|0.017|TWO_SIDED|95.0|-0.38|-0.04||Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||-0.04|-0.38|=0.017
91789337|NCT01087788|183458668|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|=|0.261|TWO_SIDED|95.0|-0.27|0.07||Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||0.07|-0.27|=0.261
91789338|NCT01087788|183458669|SUPERIORITY_OR_OTHER||Difference in Percentages|40.2|||<|0.001|TWO_SIDED|95.0|29.5|51.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||51.0|29.5|<0.001
91523980|NCT01216163|182923466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.84|||<|0.001|TWO_SIDED|95.0|5.13|27.36||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||27.36|5.13|<0.001
91654616|NCT01202747|183201676|SUPERIORITY_OR_OTHER|||||||0.0005||||||p\<0.05 considered statistically significant|Regression, Linear|||||||0.0005
91654617|NCT00601484|183201720|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.36|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-2.203|-0.51||||||Analysis was based on analysis of covariance (ANCOVA) model with terms for treatment, age, gender, body mass index (BMI), baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.510|-2.203|
91654618|NCT00601484|183201721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-1.363|0.011||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.011|-1.363|
91654619|NCT00601484|183201721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.498|||TWO_SIDED|90.0|-1.969|-0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.297|-1.969|
91654620|NCT00601484|183201721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-1.79|0.09||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.090|-1.790|
91789339|NCT01087788|183458669|SUPERIORITY_OR_OTHER||Difference in Percentages|32.8|||<|0.001|TWO_SIDED|95.0|21.8|43.8||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||43.8|21.8|<0.001
91789340|NCT01087788|183458670|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.42|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.42|<0.001
91789341|NCT01087788|183458671|SUPERIORITY_OR_OTHER||Difference in Percentages|46.3|||<|0.001|TWO_SIDED|95.0|35.7|56.9||Difference of Certolizumab Pegol 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||56.9|35.7|<0.001
91789342|NCT01087788|183458672|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|=|0.127|TWO_SIDED|95.0|-0.43|0.05||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the predefined analysis.||0.05|-0.43|=0.127
91612075|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.79|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.19|-2.79|<0.001
91612076|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.9|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.31|-2.90|<0.001
91612077|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.87|-1.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.27|-2.87|<0.001
91612078|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.98|-1.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.39|-2.98|<0.001
91612079|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.92|-1.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.30|-2.92|<0.001
91612080|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-3.19|-1.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.59|-3.19|<0.001
91654621|NCT00601484|183201721|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-1.356|0.457||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.457|-1.356|
91654622|NCT00601484|183201722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.68|STANDARD_ERROR_OF_MEAN|6.727|||TWO_SIDED|90.0|-19.954|2.601||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.601|-19.954|
91654623|NCT00601484|183201722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.74|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|90.0|-31.948|-3.523||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.523|-31.948|
91612081|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.95|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.25|-2.95|<0.001
91612082|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.27|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.11|-1.42||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.42|-3.11|<0.001
91612083|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.25|-1.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.54|-3.25|<0.001
91612084|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.23|-1.55||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.55|-3.23|<0.001
91612085|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.93|-1.22||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.22|-2.93|<0.001
91612086|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.0|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.31|-3.00|<0.001
91612087|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.05|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.37|-3.05|<0.001
91612088|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.98|-1.33||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.33|-2.98|<0.001
91612089|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.34|-1.62||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.62|-3.34|<0.001
91612090|NCT04003155|183118656|SUPERIORITY||LSMean Difference|-2.45|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.3|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.60|-3.30|<0.001
91612091|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
91612092|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
91612093|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.003|TWO_SIDED|95.0|-0.24|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.05|-0.24|0.003
91612094|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.25|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.06|-0.25|0.002
91612095|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.27|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.05|-0.27|0.004
91612096|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.003|TWO_SIDED|95.0|-0.28|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.06|-0.28|0.003
91612097|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.05|-0.29|0.006
91612098|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.29|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.06|-0.29|0.004
91612099|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.07|-0.33|0.003
91612100|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.13|-0.38|<0.001
91612101|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.11|-0.37|<0.001
91612102|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.13|-0.39|<0.001
91612103|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.15|-0.41|<0.001
91612104|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.37|<0.001
91612105|NCT04003155|183118657|SUPERIORITY||MMRM|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.41|<0.001
91612106|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.06|-0.35|0.004
91612107|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.13|-0.43|<0.001
91612108|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.37|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.08|-0.37|0.002
91612109|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.12|-0.43|<0.001
91612110|NCT04003155|183118657|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.09|-0.40|0.002
91612111|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-15.52|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED|95.0|-21.99|-9.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-9.06|-21.99|<0.001
91612112|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-12.22|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-18.69|-5.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.74|-18.69|<0.001
91612113|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-24.32|-10.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-10.27|-24.32|<0.001
91612114|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-25.3|-11.29||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-11.29|-25.30|<0.001
91612115|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-18.13|STANDARD_ERROR_OF_MEAN|3.63|<|0.001|TWO_SIDED|95.0|-25.25|-11.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-11.00|-25.25|<0.001
91612116|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-21.19|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-28.29|-14.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-14.09|-28.29|<0.001
91612117|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-16.75|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-24.24|-9.26||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-9.26|-24.24|<0.001
91612118|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-21.05|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-28.5|-13.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.61|-28.50|<0.001
91612119|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-17.57|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-25.02|-10.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-10.12|-25.02|<0.001
91612120|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-21.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-29.18|-14.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-14.39|-29.18|<0.001
91613567|NCT04172831|183121451|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.1|-0.7|0.010
91612121|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-18.39|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-26.03|-10.75||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-10.75|-26.03|<0.001
91612122|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-23.83|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-31.39|-16.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-16.27|-31.39|<0.001
91612123|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-26.33|-10.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-10.25|-26.33|<0.001
91612124|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-21.41|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-29.35|-13.48||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.48|-29.35|<0.001
91612125|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-20.16|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.14|-12.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.19|-28.14|<0.001
91612126|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-21.17|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-29.04|-13.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-13.30|-29.04|<0.001
91612127|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-16.67|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-24.73|-8.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-8.61|-24.73|<0.001
91612128|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-18.89|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-26.84|-10.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-10.94|-26.84|<0.001
91612129|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-17.88|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-25.77|-9.99||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-9.99|-25.77|<0.001
91612130|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-19.5|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-27.28|-11.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-11.72|-27.28|<0.001
91612131|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-20.32|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.3|-12.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.35|-28.30|<0.001
91612132|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-22.14|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-30.0|-14.28||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-14.28|-30.00|<0.001
91613568|NCT04172831|183121452|SUPERIORITY||Odds Ratio (OR)|1.44||||0.058|TWO_SIDED|95.0|0.99|2.1|||Regression, Logistic|||||2.10|0.99|0.058
91613569|NCT04172831|183121453|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.6||0.007|TWO_SIDED|95.0|-7.5|-1.2|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.2|-7.5|0.007
91613570|NCT04172831|183121454|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.69||0.009|TWO_SIDED|95.0|-7.7|-1.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.1|-7.7|0.009
91613571|NCT04172831|183121455|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-4.5|-1.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.3|-4.5|<0.001
91612133|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-20.08|STANDARD_ERROR_OF_MEAN|4.13|<|0.001|TWO_SIDED|95.0|-28.19|-11.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-11.96|-28.19|<0.001
91612134|NCT04003155|183118658|SUPERIORITY||LSMean Difference|-24.18|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-32.16|-16.2||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-16.20|-32.16|<0.001
91612135|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.245|||<|0.001|TWO_SIDED|95.0|1.823|5.999||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.999|1.823|<0.001
91612136|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.964|||<|0.001|TWO_SIDED|95.0|1.658|5.497||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.497|1.658|<0.001
91612137|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.187||||0.001|TWO_SIDED|95.0|1.363|3.549||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||3.549|1.363|0.001
91612138|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.847|||<|0.001|TWO_SIDED|95.0|1.786|4.601||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.601|1.786|<0.001
91612139|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.096||||0.002|TWO_SIDED|95.0|1.326|3.345||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.345|1.326|0.002
91612140|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.333|||<|0.001|TWO_SIDED|95.0|2.121|5.302||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||5.302|2.121|<0.001
91612141|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.061||||0.001|TWO_SIDED|95.0|1.323|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||3.233|1.323|0.001
91654624|NCT00601484|183201722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-20.66|STANDARD_ERROR_OF_MEAN|8.138|||TWO_SIDED|90.0|-34.347|-6.971||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.971|-34.347|
91654625|NCT00601484|183201722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.58|STANDARD_ERROR_OF_MEAN|9.532|||TWO_SIDED|90.0|-29.612|2.452||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.452|-29.612|
91612142|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.025|||<|0.001|TWO_SIDED|95.0|1.947|4.746||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.746|1.947|<0.001
91612143|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.363|3.357||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.357|1.363|<0.001
91612144|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.223|||<|0.001|TWO_SIDED|95.0|2.067|5.08||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||5.080|2.067|<0.001
91654626|NCT00601484|183201722|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.75|STANDARD_ERROR_OF_MEAN|8.807|||TWO_SIDED|90.0|-22.58|7.08||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.080|-22.580|
91654627|NCT00601484|183201723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.721|||TWO_SIDED|90.0|-1.768|0.65||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.650|-1.768|
91654628|NCT00601484|183201723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.898|||TWO_SIDED|90.0|-2.723|0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.297|-2.723|
91791308|NCT00492063|183460305|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.||3|-3|
91791309|NCT00492063|183460305|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.||3|-4|
91710441|NCT01151345|183313553|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|83.25|||||TWO_SIDED|90.0|67.08|103.31||||||Natural-log transformed Cmax was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||103.31|67.08|
91523981|NCT01216163|182923466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.468|TWO_SIDED|95.0|0.81|1.6||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||1.60|0.81|0.468
91523982|NCT01216163|182923466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.43|||<|0.001|TWO_SIDED|95.0|4.5|24.17||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||24.17|4.50|<0.001
91523983|NCT01216163|182923467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|14.06|||<|0.001|TWO_SIDED|95.0|6.02|32.8||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||32.80|6.02|<0.001
91523984|NCT01216163|182923467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.323|TWO_SIDED|95.0|0.84|1.68||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.68|0.84|0.323
91523985|NCT01216163|182923467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.81|||<|0.001|TWO_SIDED|95.0|5.06|27.59||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||27.59|5.06|<0.001
91523986|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.83|0.24|<0.001
91523987|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.101|TWO_SIDED|95.0|-0.04|0.44||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.04|0.101
91523988|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.029|TWO_SIDED|95.0|0.03|0.62||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|0.03|0.029
91523989|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.44|||<|0.001|TWO_SIDED|95.0|1.01|1.87||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.87|1.01|<0.001
91612145|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.049||||0.002|TWO_SIDED|95.0|1.317|3.21||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.210|1.317|0.002
91612146|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.097|||<|0.001|TWO_SIDED|95.0|1.994|4.858||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.858|1.994|<0.001
91612147|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|1.984||||0.002|TWO_SIDED|95.0|1.28|3.097||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.097|1.280|0.002
91612148|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.062|||<|0.001|TWO_SIDED|95.0|1.977|4.788||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.788|1.977|<0.001
91612149|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.748|||<|0.001|TWO_SIDED|95.0|1.774|4.294||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.294|1.774|<0.001
91612150|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.379|||<|0.001|TWO_SIDED|95.0|1.536|3.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||3.712|1.536|<0.001
91612151|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.051||||0.001|TWO_SIDED|95.0|1.329|3.186||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.186|1.329|0.001
91710442|NCT01087203|183313569|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.53||0.025|TWO_SIDED|95.0|-2.28|-0.16|||ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.16|-2.28|0.025
91789343|NCT01087788|183458672|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.26|=|0.048|TWO_SIDED|95.0|-1.04|-0.01||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the post-hoc analysis for the subgroup 'Baseline mTSS \> 6'.||-0.01|-1.04|=0.048
91789344|NCT00043550|183458679|SUPERIORITY|The proposed sample size had at least 80% power to detect effect sizes of 0.36 between the two active treatment conditions and placebo during the active phase. These power calculations were based on a priori values of within-subject correlation of 0.50, 10% attrition, and 6 assessment points.|Slope|1.0||||0.95|TWO_SIDED|||||Overall significant effect for treatment, as well as the two moderating effects, used a Bonferroni-corrected alpha level of 0.0167 (0.05/3).|HLM|||Comparison of conditions||||.95
91789345|NCT00043550|183458679|SUPERIORITY||||||<|0.0001|||||||HLM|||effects of conditions over time||||<.0001
91789346|NCT00043550|183458679|SUPERIORITY||Slope|0.03|||||TWO_SIDED|95.0|-0.35|0.41||||||||.41|-.35|
91789347|NCT00043550|183458679|SUPERIORITY||Slope|0.06|||||TWO_SIDED|95.0|-0.33|0.45||||||||.45|-.33|
91612152|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.701|||<|0.001|TWO_SIDED|95.0|1.75|4.204||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||4.204|1.750|<0.001
91612153|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.725|||<|0.001|TWO_SIDED|95.0|1.742|4.306||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.306|1.742|<0.001
91612154|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.921|||<|0.001|TWO_SIDED|95.0|2.505|6.214||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.214|2.505|<0.001
91612155|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.104|||<|0.001|TWO_SIDED|95.0|1.363|3.27||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.270|1.363|<0.001
91612156|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|2.953|||<|0.001|TWO_SIDED|95.0|1.912|4.602||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.602|1.912|<0.001
91612157|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|1.894||||0.005|TWO_SIDED|95.0|1.22|2.961||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.961|1.220|0.005
91612158|NCT04003155|183118659|SUPERIORITY||Odds Ratio (OR)|3.156|||<|0.001|TWO_SIDED|95.0|2.035|4.944||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.944|2.035|<0.001
91612159|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|3.158||||0.322|TWO_SIDED|95.0|0.398|64.304||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||64.304|0.398|0.322
91612160|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|3.925||||0.225|TWO_SIDED|95.0|0.569|77.353||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||77.353|0.569|0.225
91612161|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|6.334||||0.089|TWO_SIDED|95.0|1.064|120.422||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||120.422|1.064|0.089
91612162|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|5.026||||0.143|TWO_SIDED|95.0|0.797|96.916||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||96.916|0.797|0.143
91612163|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|1.257||||0.711|TWO_SIDED|95.0|0.37|4.468||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.468|0.370|0.711
91612164|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|1.57||||0.441|TWO_SIDED|95.0|0.508|5.328||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.328|0.508|0.441
91523990|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.178|TWO_SIDED|95.0|-0.11|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.11|0.178
91523991|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|0.77|<0.001
91523992|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||<|0.001|TWO_SIDED|95.0|1.64|2.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.49|1.64|<0.001
91523993|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.44||||0.014|TWO_SIDED|95.0|0.09|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.09|0.014
91523994|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.21|2.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.06|1.21|<0.001
91523995|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.79|2.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.70|1.79|<0.001
91523996|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.055|TWO_SIDED|95.0|-0.01|0.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.74|-0.01|0.055
91523997|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.34||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.34|1.43|<0.001
91523998|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|2.31|||<|0.001|TWO_SIDED|95.0|1.8|2.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.83|1.80|<0.001
91523999|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.51||||0.019|TWO_SIDED|95.0|0.08|0.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.93|0.08|0.019
91524000|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.29|<0.001
91524001|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.66|1.53|<0.001
91524002|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.59||||0.013|TWO_SIDED|95.0|0.13|1.05||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.05|0.13|0.013
91524003|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.51|||<|0.001|TWO_SIDED|95.0|0.95|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.95|<0.001
91524004|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.56||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.56|1.39|<0.001
91524005|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.63||||0.01|TWO_SIDED|95.0|0.15|1.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.10|0.15|0.010
91524006|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.35|||<|0.001|TWO_SIDED|95.0|0.77|1.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.93|0.77|<0.001
91524007|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.54|||<|0.001|TWO_SIDED|95.0|0.95|2.14||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.14|0.95|<0.001
91524008|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.088|TWO_SIDED|95.0|-0.06|0.91||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.91|-0.06|0.088
91613572|NCT04172831|183121456|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.018|TWO_SIDED|95.0|-3.3|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-3.3|0.018
91613573|NCT04172831|183121457|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-0.9|<0.001
91613574|NCT04036136|183121462|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.36||||0.724|TWO_SIDED|95.0|-2.41|1.68|||ANCOVA|||Model covariates are Baseline SHAPS, age, and sex.||1.68|-2.41|0.724
91613575|NCT04036136|183121463|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.043||||0.292|TWO_SIDED|95.0|-0.124|0.038|||Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.038|-0.124|0.292
91613576|NCT04036136|183121464|EQUIVALENCE|The equivalence margin is 0.|Median Difference (Final Values)|-0.148||||0.084|TWO_SIDED|95.0|-0.316|0.02||The equivalence margin is 0.|Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.020|-0.316|0.084
91524009|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.52|1.71||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.71|0.52|<0.001
91789348|NCT02285062|183458690|SUPERIORITY||Hazard Ratio (HR)|0.849||||0.2864|TWO_SIDED|95.0|0.632|1.14|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors|||1.140|0.632|0.2864
91789349|NCT02285062|183458691|SUPERIORITY||Hazard Ratio (HR)|1.038||||0.7294|TWO_SIDED|95.0|0.802|1.344|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.344|0.802|0.7294
91789350|NCT02285062|183458692|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.876|TWO_SIDED|95.0|0.716|1.3|||Log Rank|Log-rank test stratified by 3 factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.300|0.716|0.8760
91789351|NCT02285062|183458693|SUPERIORITY|||||||0.2933||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.2933
91524010|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|0.85|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.85|<0.001
91524011|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.47||||0.061|TWO_SIDED|95.0|-0.02|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|-0.02|0.061
91524012|NCT01216163|182923468|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.002|TWO_SIDED|95.0|0.38|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.38|0.002
91524013|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.31|||<|0.001|TWO_SIDED|95.0|0.13|0.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.49|0.13|<0.001
91524014|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.06||||0.387|TWO_SIDED|95.0|-0.08|0.21||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.21|-0.08|0.387
91612165|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|5.351||||0.032|TWO_SIDED|95.0|1.383|35.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||35.172|1.383|0.032
91612166|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|3.059||||0.175|TWO_SIDED|95.0|0.693|21.086||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||21.086|0.693|0.175
91612167|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|4.225||||0.071|TWO_SIDED|95.0|1.039|28.29||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||28.290|1.039|0.071
91612168|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|5.22||||0.035|TWO_SIDED|95.0|1.348|34.323||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||34.323|1.348|0.035
91612169|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|7.064||||0.011|TWO_SIDED|95.0|1.912|45.64||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||45.640|1.912|0.011
91612170|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|6.949||||0.012|TWO_SIDED|95.0|1.881|44.892||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||44.892|1.881|0.012
91612171|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|5.344||||0.032|TWO_SIDED|95.0|1.381|35.134||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||35.134|1.381|0.032
91789352|NCT02285062|183458694|SUPERIORITY|||||||0.9964||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.9964
91789353|NCT02285062|183458695|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2143|TWO_SIDED|95.0|0.521|1.157|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR was derived from COX model adjusting for the 3 stratification factors mentioned above.|||1.157|0.521|0.2143
91789354|NCT02285062|183458696|SUPERIORITY||Hazard Ratio (HR)|1.167||||0.315||95.0|0.856|1.59|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR is derived from Cox model|||1.590|0.856|0.3150
91524015|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.007|TWO_SIDED|95.0|0.07|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|0.07|0.007
91654629|NCT00601484|183201723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|1.311|||TWO_SIDED|90.0|-3.682|0.752||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.752|-3.682|
91654630|NCT00601484|183201723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-1.11|2.198||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.198|-1.110|
91654631|NCT00601484|183201723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.114|||TWO_SIDED|90.0|-2.904|0.922||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.922|-2.904|
91524016|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.89|||<|0.001|TWO_SIDED|95.0|0.64|1.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.15|0.64|<0.001
91524017|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.019|TWO_SIDED|95.0|0.04|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.04|0.019
91524018|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.64|||<|0.001|TWO_SIDED|95.0|0.38|0.9||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.90|0.38|<0.001
91524019|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.001|TWO_SIDED|95.0|1.01|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|1.01|<0.001
91524020|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.006|TWO_SIDED|95.0|0.09|0.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.57|0.09|0.006
91524021|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.97|||<|0.001|TWO_SIDED|95.0|0.68|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.68|<0.001
91524022|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.12|1.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.74|1.12|<0.001
91524023|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.32||||0.014|TWO_SIDED|95.0|0.07|0.58||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|0.07|0.014
91524024|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.11|||<|0.001|TWO_SIDED|95.0|0.8|1.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.42|0.80|<0.001
91524025|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.09|1.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.78|1.09|<0.001
91524026|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.03|TWO_SIDED|95.0|0.03|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|0.03|0.030
91654632|NCT00601484|183201724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|90.0|-13.65|4.826||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.826|-13.650|
91654633|NCT00601484|183201724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.65|STANDARD_ERROR_OF_MEAN|7.041|||TWO_SIDED|90.0|-20.493|3.192||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.192|-20.493|
91524027|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.78|1.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.46|0.78|<0.001
91710443|NCT01087203|183313570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.332|TWO_SIDED|95.0|-0.92|0.32|||ANCOVA|||Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.32|-0.92|0.332
91524028|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.29|||<|0.001|TWO_SIDED|95.0|0.91|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.91|<0.001
91524029|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.007|TWO_SIDED|95.0|0.12|0.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.73|0.12|0.007
91524030|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.49|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|0.49|<0.001
91524031|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.89|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.89|<0.001
91524032|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.004|TWO_SIDED|95.0|0.15|0.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.76|0.15|0.004
91524033|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.44|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.44|<0.001
91524034|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.54|1.31||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|0.54|<0.001
91524035|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.084|TWO_SIDED|95.0|-0.04|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.04|0.084
91524036|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.27|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|0.27|0.001
91612172|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|7.514||||0.008|TWO_SIDED|95.0|2.055|48.354||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||48.354|2.055|0.008
91612173|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|3.238||||0.026|TWO_SIDED|95.0|1.222|10.148||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.148|1.222|0.026
91524037|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.54|1.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.32|0.54|<0.001
91612174|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|3.438||||0.019|TWO_SIDED|95.0|1.311|10.714||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.714|1.311|0.019
91612175|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|2.626||||0.037|TWO_SIDED|95.0|1.101|6.951||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.951|1.101|0.037
91789355|NCT00545129|183458705|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.45||0.569|TWO_SIDED|95.0|-1.18|0.66|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.||0.66|-1.18|0.569
91612176|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|2.758||||0.027|TWO_SIDED|95.0|1.167|7.263||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||7.263|1.167|0.027
91612177|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|1.69||||0.21|TWO_SIDED|95.0|0.753|3.968||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.968|0.753|0.210
91612178|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|2.01||||0.087|TWO_SIDED|95.0|0.923|4.634||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.634|0.923|0.087
91612179|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|2.1||||0.148|TWO_SIDED|95.0|0.795|6.157||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||6.157|0.795|0.148
91612180|NCT04003155|183118660|SUPERIORITY||Odds Ratio (OR)|3.262||||0.015|TWO_SIDED|95.0|1.329|9.194||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||9.194|1.329|0.015
91612181|NCT04760314|183118688|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.6|33.6|||Cochran-Mantel-Haenszel|||||33.6|11.6|<0.001
91612182|NCT04760314|183118688|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.001|TWO_SIDED|95.0|17.5|37.0|||Cochran-Mantel-Haenszel|||||37.0|17.5|<0.001
91789356|NCT00545129|183458706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.581|TWO_SIDED|95.0|-0.6|0.34|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.34|-0.60|0.581
91612183|NCT04760314|183118689|SUPERIORITY||Risk Difference (RD)|33.2|||<|0.001|TWO_SIDED|95.0|20.6|45.8|||Cochran-Mantel-Haenszel|||||45.8|20.6|<0.001
91612184|NCT04760314|183118689|SUPERIORITY||Risk Difference (RD)|37.6|||<|0.001|TWO_SIDED|95.0|26.2|49.0|||Cochran-Mantel-Haenszel|||||49.0|26.2|<0.001
91612185|NCT04760314|183118690|SUPERIORITY||LS Mean Difference|-34.5|||<|0.001|TWO_SIDED|95.0|-44.1|-24.9|||ANCOVA|||||-24.9|-44.1|<0.001
91612186|NCT04760314|183118690|SUPERIORITY||LS Mean Difference|-38.99|||<|0.001|TWO_SIDED|95.0|-47.7|-30.3|||ANCOVA|||||-30.3|-47.7|<0.001
91612187|NCT04760314|183118691|SUPERIORITY||Risk Difference (RD)|18.4||||0.003|TWO_SIDED|95.0|6.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|6.8|0.003
91612188|NCT04760314|183118691|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|13.9|34.5|||Cochran-Mantel-Haenszel|||||34.5|13.9|<0.001
91612189|NCT04760314|183118692|SUPERIORITY||Risk Difference (RD)|1.2||||0.404|TWO_SIDED|95.0|-1.2|3.6|||Cochran-Mantel-Haenszel|||||3.6|-1.2|0.404
91612190|NCT04760314|183118693|SUPERIORITY||Risk Difference (RD)|1.8||||0.294|TWO_SIDED|95.0|-1.6|5.1|||Cochran-Mantel-Haenszel|||||5.1|-1.6|0.294
91612191|NCT04760314|183118693|SUPERIORITY||Risk Difference (RD)|3.7||||0.138|TWO_SIDED|95.0|-0.5|7.8|||Cochran-Mantel-Haenszel|||||7.8|-0.5|0.138
91612192|NCT04760314|183118694|SUPERIORITY||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.8|16.5|||Cochran-Mantel-Haenszel|||||16.5|1.8|0.013
91612193|NCT04760314|183118694|SUPERIORITY||Risk Difference (RD)|16.2||||0.001|TWO_SIDED|95.0|8.1|24.3|||Cochran-Mantel-Haenszel|||||24.3|8.1|0.001
91612194|NCT04760314|183118695|SUPERIORITY||Risk Difference (RD)|20.6||||0.001|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|||||32.4|8.7|0.001
91789357|NCT00545129|183458706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.795|TWO_SIDED|95.0|-0.56|0.73|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-0.56|0.795
91612195|NCT04760314|183118695|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|17.9|40.4|||Cochran-Mantel-Haenszel|||||40.4|17.9|<0.001
91612196|NCT01371838|183118702|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was \>0% superioirty was concluded.|Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.||17.1|2.8|
91612197|NCT01371838|183118703|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.7|||||TWO_SIDED|95.0|4.9|16.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||16.4|4.9|
91789358|NCT00545129|183458706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.41||0.843|TWO_SIDED|95.0|-0.76|0.93|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.93|-0.76|0.843
91612198|NCT01371838|183118704|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|1.8|15.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||15.4|1.8|
91612199|NCT01371838|183118705|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was \>0% superioirty was concluded in this population.|||19.2|6.8|
91612200|NCT01371838|183118706|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
91612201|NCT01371838|183118707|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
91612202|NCT01371838|183118710|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
91654634|NCT00601484|183201724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.72|STANDARD_ERROR_OF_MEAN|10.089|||TWO_SIDED|90.0|-26.775|7.343||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.343|-26.775|
91612203|NCT01371838|183118711|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
91612204|NCT01371838|183118712|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline minus Ceftriaxone overall success rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||19.2|6.8|
91612205|NCT01371838|183118713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||17.1|2.8|
91612206|NCT01371838|183118714|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.5|3.0||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||3.0|-2.5|
91654635|NCT00601484|183201724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|7.532|||TWO_SIDED|90.0|-8.95|16.465||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.465|-8.950|
91789359|NCT00545129|183458706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.43||0.292|TWO_SIDED|95.0|-1.34|0.42|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.42|-1.34|0.292
91789360|NCT00545129|183458707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
91612207|NCT01371838|183118715|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.4|4.5||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||4.5|-2.4|
91612208|NCT04315363|183118718|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the primary outcome changes (i.e., sedentary time) before and after the intervention.||||||0.8|||||||ANOVA|||||||0.8
91612209|NCT04315363|183118719|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the secondary outcome changes (i.e., moderate-to-vigorous physical activity) before and after the intervention.||||||0.35|||||||ANOVA|||||||0.35
91612210|NCT00641043|183118726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.3|||ANCOVA|||Linagliptin vs. Placebo||-0.30|-0.71|<0.0001
91612211|NCT00641043|183118727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.52|-0.24|||ANCOVA|||Linagliptin vs. Placebo||-0.24|-0.52|<0.0001
91612212|NCT00641043|183118728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.67|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.67|<0.0001
91612213|NCT00641043|183118729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.70|<0.0001
91612214|NCT00641043|183118730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001||95.0|-21.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-21.1|<0.0001
91612215|NCT00641043|183118731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001||95.0|-22.3|-10.5|||ANCOVA|||Linagliptin vs. Placebo||-10.5|-22.3|<0.0001
91612216|NCT00641043|183118732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001||95.0|-19.5|-7.0|||ANCOVA|||Linagliptin vs. Placebo||-7.0|-19.5|<0.0001
91612217|NCT00641043|183118733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-20.5|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-20.5|<0.0001
91612218|NCT00641043|183118734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.103||||0.0051||95.0|1.25|3.539|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||3.539|1.25|0.0051
91612219|NCT00641043|183118736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.348||||0.3547||95.0|0.716|2.537|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||2.537|0.716|0.3547
91612220|NCT00641043|183118738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.823|||<|0.0001||95.0|2.286|6.394|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||6.394|2.286|<0.0001
91612221|NCT02345161|183118754|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.171|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.148|0.194|||Mixed Model Repeated Measures|||||0.194|0.148|<0.001
91612222|NCT02345161|183118755|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.179|STANDARD_ERROR_OF_MEAN|0.0242|<|0.001|TWO_SIDED|95.0|0.131|0.226|||Mixed Model Repeated Measures|||||0.226|0.131|<0.001
91612223|NCT02345161|183118756|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0|||Mixed Model Repeated Measures|||||-1.0|-3.5|<0.001
91612224|NCT02345161|183118757|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.44||0.065|TWO_SIDED|95.0|-5.5|0.2|||Mixed Model Repeated Measures|||||0.2|-5.5|0.065
91612225|NCT02345161|183118758|SUPERIORITY_OR_OTHER||LS Mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|0.3|0.84|||Mixed effect repeated measures model|||||0.84|0.30|<0.001
91612226|NCT02345161|183118759|SUPERIORITY_OR_OTHER||LS Mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.317||0.279|TWO_SIDED|95.0|-0.28|0.97|||Mixed effect repeated measures model|||||0.97|-0.28|0.279
91612227|NCT02345161|183118760|SUPERIORITY_OR_OTHER||LS Mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.817|TWO_SIDED|95.0|-0.9|1.1|||ANCOVA|||||1.1|-0.9|0.817
91612228|NCT02345161|183118761|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.767|TWO_SIDED|95.0|-2.1|1.6|||ANCOVA|||||1.6|-2.1|0.767
91612229|NCT02345161|183118762|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.002|TWO_SIDED|95.0|0.49|0.86|||Generalized linear modeL|Generalized linear model assuming a negative binomial distribution||||0.86|0.49|0.002
91612230|NCT02345161|183118763|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.006|TWO_SIDED|95.0|0.37|0.85|||Generalized Linear model|Generalized linear model assuming a negative binomial distribution||||0.85|0.37|0.006
91612231|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.25|-0.66|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||-0.66|-1.25|<0.001
91612232|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.183|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.87|-1.59|<0.001
91612233|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.201|<|0.001|TWO_SIDED|95.0|-1.57|-0.78|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.78|-1.57|<0.001
91612234|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.213|<|0.001|TWO_SIDED|95.0|-1.75|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.91|-1.75|<0.001
91612235|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.223|<|0.001|TWO_SIDED|95.0|-1.85|-0.97|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.97|-1.85|<0.001
91612236|NCT02345161|183118764|SUPERIORITY_OR_OTHER||Mixed Model Repeated Measures|-1.35|STANDARD_ERROR_OF_MEAN|0.224|<|0.001|TWO_SIDED|95.0|-1.79|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 21-24|||-0.91|-1.79|<0.001
91654636|NCT00601484|183201724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.906|||TWO_SIDED|90.0|-22.299|4.851||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.851|-22.299|
91654637|NCT00601484|183201725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|90.0|-0.776|1.265||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.265|-0.776|
91654638|NCT00601484|183201725|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.674|||TWO_SIDED|90.0|-1.22|1.044||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.044|-1.220|
91654639|NCT00601484|183201725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.57|STANDARD_ERROR_OF_MEAN|1.009|||TWO_SIDED|90.0|-1.124|2.269||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.269|-1.124|
91654640|NCT00601484|183201725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|-1.441|1.988||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.988|-1.441|
91654641|NCT00601484|183201725|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99|STANDARD_ERROR_OF_MEAN|0.769|||TWO_SIDED|90.0|-0.307|2.283||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.283|-0.307|
91654642|NCT00601484|183201726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.68|||||TWO_SIDED|90.0|-9.05|5.76||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.76|-9.05|
91654643|NCT00601484|183201726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-2.78|||||TWO_SIDED|90.0|-12.65|4.24||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.24|-12.65|
91612237|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.67|-0.36|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 1-4|||-0.36|-0.67|<0.001
91612238|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.88|-0.5|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 5-8|||-0.50|-0.88|<0.001
91612239|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.9|-0.48|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 9-12|||-0.48|-0.90|<0.001
91612240|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.115|<|0.001|TWO_SIDED|95.0|-0.97|-0.52|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 13-16|||-0.52|-0.97|<0.001
91612241|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 17-20|||-0.56|-1.03|<0.001
91612242|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.01|-0.54|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 21-24|||-0.54|-1.01|<0.001
91612243|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.26|-0.09|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 1-4|||-0.09|-0.26|<0.001
91612244|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|95.0|-0.31|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 5-8|||-0.10|-0.31|<0.001
91654644|NCT00601484|183201726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|0.04|||||TWO_SIDED|90.0|-8.96|7.9||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||7.90|-8.96|
91654645|NCT00601484|183201726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.38|||||TWO_SIDED|90.0|-11.57|8.28||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||8.28|-11.57|
91654646|NCT00601484|183201726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|3.97|||||TWO_SIDED|90.0|-6.82|13.02||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||13.02|-6.82|
91654647|NCT00601484|183201727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.414|0.983||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.983|-2.414|
91654648|NCT00601484|183201727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|-1.548|2.384||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.384|-1.548|
91654649|NCT00601484|183201727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|0.821|||TWO_SIDED|90.0|-0.075|2.693||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.693|-0.075|
91654650|NCT00601484|183201727|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|-2.178|1.512||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.512|-2.178|
91654651|NCT00601484|183201727|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.07|STANDARD_ERROR_OF_MEAN|1.208|||TWO_SIDED|90.0|0.038|4.112||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.112|0.038|
91654652|NCT00601484|183201728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-6.41|||||TWO_SIDED|90.0|-33.33|18.68||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||18.68|-33.33|
91710444|NCT01087203|183313570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.297|TWO_SIDED|95.0|-1.15|0.36|||ANCOVA|||Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.36|-1.15|0.297
91654653|NCT00601484|183201728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|15.83|||||TWO_SIDED|90.0|-14.12|41.18||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||41.18|-14.12|
91654654|NCT00601484|183201728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|19.17|||||TWO_SIDED|90.0|0.0|38.1||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||38.10|0.00|
91654655|NCT00601484|183201728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-0.71|||||TWO_SIDED|90.0|-30.95|32.73||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||32.73|-30.95|
91710445|NCT01087203|183313570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.81|-0.1|||ANCOVA|||Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.10|-1.81|0.029
91524038|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.38||||0.02|TWO_SIDED|95.0|0.06|0.69||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.06|0.020
91612245|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.058||0.004|TWO_SIDED|95.0|-0.28|-0.05|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 9-12|||-0.05|-0.28|0.004
91612246|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.061|<|0.001|TWO_SIDED|95.0|-0.34|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 13-16|||-0.10|-0.34|<0.001
91612247|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.064|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 17-20|||-0.11|-0.36|<0.001
91612248|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 21-24|||-0.10|-0.35|<0.001
91612249|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.37|-0.18|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 1-4|||-0.18|-0.37|<0.001
91612250|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.46|-0.23|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 5-8|||-0.23|-0.46|<0.001
91612251|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.47|-0.21|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 9-12|||-0.21|-0.47|<0.001
91612252|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 13-16|||-0.25|-0.51|<0.001
91654656|NCT00601484|183201728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|34.89|||||TWO_SIDED|90.0|-4.57|70.0||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||70.00|-4.57|
91612253|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.53|-0.26|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 17-20|||-0.26|-0.53|<0.001
91612254|NCT02345161|183118764|SUPERIORITY_OR_OTHER||LS Mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|95.0|-0.5|-0.22|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 21-24|||-0.22|-0.50|<0.001
91612255|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.311||0.094|TWO_SIDED|95.0|-1.13|0.09|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||0.09|-1.13|0.094
91612256|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.07|STANDARD_ERROR_OF_MEAN|0.371||0.004|TWO_SIDED|95.0|-1.8|-0.34|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.34|-1.80|0.004
91612257|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.419||0.022|TWO_SIDED|95.0|-1.79|-0.14|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.14|-1.79|0.022
91612258|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.445||0.024|TWO_SIDED|95.0|-1.88|-0.13|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.13|-1.88|0.024
91612259|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.17|-2.06|0.021
91612260|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.022|TWO_SIDED|95.0|-2.05|-0.16|||Mixed Model Repeated Measures||EXACT-RS Score, Week 21-24|||-0.16|-2.05|0.022
91612261|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.492||0.008|TWO_SIDED|95.0|-2.29|-0.35|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 25-28|||-0.35|-2.29|0.008
91612262|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.494||0.004|TWO_SIDED|95.0|-2.4|-0.46|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 29-32|||-0.46|-2.40|0.004
91612263|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.519||0.004|TWO_SIDED|95.0|-2.52|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 33-36|||-0.48|-2.52|0.004
91789361|NCT00545129|183458707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
91612264|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.507||0.016|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 37-40|||-0.23|-2.22|0.016
91789362|NCT00545129|183458707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED|95.0|-0.74|0.98|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.98|-0.74|0.776
91612265|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.513||0.04|TWO_SIDED|95.0|-2.5|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 41-44|||-0.48|-2.50|0.04
91612266|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.525||0.007|TWO_SIDED|95.0|-2.56|-0.5|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 45-49|||-0.50|-2.56|0.007
91612267|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.524||0.007|TWO_SIDED|95.0|-2.45|-0.39|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 49-52|||-0.39|-2.45|0.007
91612268|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.169||0.051|TWO_SIDED|95.0|-0.66|0.0|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 1-4|||0.00|-0.66|0.051
91612269|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.207||0.003|TWO_SIDED|95.0|-1.02|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 5-8|||-0.20|-1.02|0.003
91654657|NCT00601484|183201729|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.529|0.61||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.610|-0.529|
91654658|NCT00601484|183201729|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.334|||TWO_SIDED|90.0|-1.077|0.043||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.043|-1.077|
91654659|NCT00601484|183201729|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.366|||TWO_SIDED|90.0|-0.835|0.396||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.396|-0.835|
91654660|NCT00601484|183201729|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.294|||TWO_SIDED|90.0|-0.718|0.273||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.273|-0.718|
91654661|NCT00601484|183201729|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.442|||TWO_SIDED|90.0|-1.044|0.445||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.445|-1.044|
91654662|NCT00601484|183201730|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.24|||||TWO_SIDED|90.0|-27.56|5.37||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.37|-27.56|
91654663|NCT00601484|183201730|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-22.43|||||TWO_SIDED|90.0|-56.39|0.0||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-56.39|
91654664|NCT00601484|183201730|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-16.0|||||TWO_SIDED|90.0|-40.44|0.0||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-40.44|
91789363|NCT00545129|183458707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.45||0.978|TWO_SIDED|95.0|-0.93|0.91|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.93|0.978
91654665|NCT00601484|183201730|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-14.18|||||TWO_SIDED|90.0|-50.71|0.0||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-50.71|
91789364|NCT00545129|183458707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.689|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-1.10|0.689
91789365|NCT00545129|183458708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
91654666|NCT00601484|183201730|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-8.61|||||TWO_SIDED|90.0|-36.87|4.64||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.64|-36.87|
91654667|NCT00601484|183201731|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|12.495|||TWO_SIDED|90.0|-15.852|26.044||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||26.044|-15.852|
91654668|NCT00601484|183201731|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|12.802|||TWO_SIDED|90.0|-17.216|25.764||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||25.764|-17.216|
91654669|NCT00601484|183201731|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|13.741|||TWO_SIDED|90.0|-25.917|20.307||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.307|-25.917|
91612270|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.234||0.01|TWO_SIDED|95.0|-1.07|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 9-12|||-0.15|-1.07|0.010
91612271|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.247||0.013|TWO_SIDED|95.0|-1.1|-0.13|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 13-16|||-0.13|-1.10|0.013
91612272|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.265||0.012|TWO_SIDED|95.0|-1.19|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 17-20|||-0.15|-1.19|0.012
91612273|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.268||0.018|TWO_SIDED|95.0|-1.16|-0.11|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 21-24|||-0.11|-1.16|0.018
91612274|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.275||0.006|TWO_SIDED|95.0|-1.3|-0.21|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 25-28|||-0.21|-1.30|0.006
91612275|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.276||0.002|TWO_SIDED|95.0|-1.4|-0.31|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 29-32|||-0.31|-1.40|0.002
91612276|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.288||0.001|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 33-36|||-0.38|-1.51|0.001
91612277|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.287||0.008|TWO_SIDED|95.0|-1.32|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 37-40|||-0.20|-1.32|0.008
91612278|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.294||0.006|TWO_SIDED|95.0|-1.4|-0.24|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 41-44|||-0.24|-1.40|0.006
91654670|NCT00601484|183201731|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|12.416|||TWO_SIDED|90.0|-21.626|20.162||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.162|-21.626|
91612279|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.299||0.004|TWO_SIDED|95.0|-1.44|-0.27|||Breathlessness score, Week 41-44||Breathlessness EXACT-RS score, Week 45-48|||-0.27|-1.44|0.004
91612280|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.294||0.003|TWO_SIDED|95.0|-1.45|-0.3|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 49-52EXA|||-0.30|-1.45|0.003
91612281|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.091||0.84|TWO_SIDED|95.0|-0.2|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 1-4|||0.16|-0.20|0.840
91612282|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.167|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 5-8|||-0.06|-0.36|0.167
91612283|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.117||0.359|TWO_SIDED|95.0|-0.34|0.12|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 9-12|||0.12|-0.34|0.359
91612284|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.36|TWO_SIDED|95.0|-0.36|0.13|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 13-16|||0.13|-0.36|0.360
91612285|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.49|TWO_SIDED|95.0|-0.36|0.17|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 17-20|||0.17|-0.36|0.490
91612286|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.138||0.388|TWO_SIDED|95.0|-0.39|0.15|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 21-24|||0.15|-0.39|0.388
91612287|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.218|TWO_SIDED|95.0|-0.44|0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 25-28|||0.10|-0.44|0.218
91612288|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.138|TWO_SIDED|95.0|-0.47|0.07|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 29-32|||0.07|-0.47|0.138
91612289|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.44|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 33-36|||0.11|-0.44|0.239
91612290|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.417|TWO_SIDED|95.0|-0.38|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 37-40|||0.16|-0.38|0.417
91612291|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.144||0.078|TWO_SIDED|95.0|-0.54|0.03|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 41-44|||0.03|-0.54|0.078
91789366|NCT00545129|183458708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
91612292|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.058|TWO_SIDED|95.0|-0.54|0.01|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 45-48|||0.01|-0.54|0.058
91612293|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.141||0.231|TWO_SIDED|95.0|-0.45|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 49-52|||0.11|-0.45|0.231
91612294|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.097||0.068|TWO_SIDED|95.0|-0.37|0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 1-4|||0.01|-0.37|0.068
91612295|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.118||0.006|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 5-8|||-0.09|-0.56|0.006
91612296|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.131||0.042|TWO_SIDED|95.0|-0.53|-0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 9-12|||-0.01|-0.53|0.042
91789367|NCT00545129|183458708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.618|TWO_SIDED|95.0|-0.68|1.13|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.13|-0.68|0.618
91789368|NCT00545129|183458708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.818|TWO_SIDED|95.0|-0.85|1.07|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.07|-0.85|0.818
91789369|NCT00545129|183458708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.48||0.819|TWO_SIDED|95.0|-0.87|1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.09|-0.87|0.819
91612297|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.027|TWO_SIDED|95.0|-0.57|-0.03|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 13-16|||-0.03|-0.57|0.027
91612298|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.146||0.01|TWO_SIDED|95.0|-0.67|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 17-20|||-0.09|-0.67|0.010
91612299|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.144||0.01|TWO_SIDED|95.0|-0.66|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 21-24|||-0.09|-0.66|0.010
91612300|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|-0.7|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 25-28|||-0.12|-0.70|
91612301|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.152||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 29-32|||-0.09|-0.68|0.011
91612302|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.157||0.011|TWO_SIDED|95.0|-0.71|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 33-36|||-0.09|-0.71|0.011
91612303|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.151||0.014|TWO_SIDED|95.0|-0.67|-0.07|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 37-40|||-0.07|-0.67|0.014
91654671|NCT00601484|183201731|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.51|STANDARD_ERROR_OF_MEAN|14.469|||TWO_SIDED|90.0|-13.858|34.868||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||34.868|-13.858|
91654672|NCT00601484|183201732|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.63|STANDARD_ERROR_OF_MEAN|6.968|||TWO_SIDED|90.0|-8.049|15.316||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.316|-8.049|
91654673|NCT00601484|183201732|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.19|STANDARD_ERROR_OF_MEAN|7.353|||TWO_SIDED|90.0|-9.153|15.533||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.533|-9.153|
91654674|NCT00601484|183201732|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|7.651|||TWO_SIDED|90.0|-13.806|11.932||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.932|-13.806|
91654675|NCT00601484|183201732|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|7.543|||TWO_SIDED|90.0|-5.901|19.486||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||19.486|-5.901|
91654676|NCT00601484|183201732|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|90.0|-9.221|18.765||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||18.765|-9.221|
91654677|NCT00601484|183201733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.407|||TWO_SIDED|90.0|-1.546|-0.182||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.182|-1.546|
91654678|NCT00601484|183201733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.484|||TWO_SIDED|90.0|-2.196|-0.57||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.570|-2.196|
91789370|NCT00545129|183458709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.34||0.906|TWO_SIDED|95.0|-0.66|0.74|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.74|-0.66|0.906
91612304|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.153||0.007|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 41-44|||-0.12|-0.72|0.007
91612305|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.006|TWO_SIDED|95.0|-0.76|-0.13|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 45-48|||-0.13|-0.76|0.006
91612306|NCT02345161|183118765|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.163||0.013|TWO_SIDED|95.0|-0.73|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 49-52|||-0.09|-0.73|0.013
91612307|NCT02345161|183118774|SUPERIORITY_OR_OTHER||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.023|TWO_SIDED|95.0|0.3|3.4|||Mixed Model Repeated Measures||For QTcF|||3.4|0.3|0.023
91612308|NCT02345161|183118774|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.471|TWO_SIDED|95.0|-2.1|1.0|||Mixed Model Repeated Measures||For PR interval|||1.0|-2.1|0.471
91654679|NCT00601484|183201733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|90.0|-2.204|-0.388||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.388|-2.204|
91654680|NCT00601484|183201733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|90.0|-2.032|-0.172||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.172|-2.032|
91654681|NCT00601484|183201733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.512|||TWO_SIDED|90.0|-1.878|-0.152||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.152|-1.878|
91654682|NCT00601484|183201734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.24|STANDARD_ERROR_OF_MEAN|8.064|||TWO_SIDED|90.0|-29.757|-2.718||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-2.718|-29.757|
91612309|NCT02345161|183118775|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.83||0.564|TWO_SIDED|95.0|-4.7|2.5|||Mixed Model Repeated Measures||For QTcF|||2.5|-4.7|0.564
91612310|NCT02345161|183118775|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.57||0.908|TWO_SIDED|95.0|-2.9|3.3|||Mixed Model Repeated Measures||For PR interval|||3.3|-2.9|0.908
91612311|NCT02345161|183118778|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.849|TWO_SIDED|95.0|-1.0|1.2|||Mixed Model Repeated Measures||Week 24, SBP|||1.2|-1.0|0.849
91612312|NCT02345161|183118778|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.613|TWO_SIDED|95.0|-0.6|0.9|||Mixed Model Repeated Measures||Week 24, DBP|||0.9|-0.6|0.613
91612313|NCT02345161|183118779|SUPERIORITY_OR_OTHER||: LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.19||0.183|TWO_SIDED|95.0|-3.9|0.8|||Mixed Model Repeated Measures||Week 52, SBP|||0.8|-3.9|0.183
91789371|NCT00545129|183458709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.906|TWO_SIDED|95.0|-0.95|0.85|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.85|-0.95|0.906
91789372|NCT00545129|183458709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.613|TWO_SIDED|95.0|-0.78|1.29|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.29|-0.78|0.613
91789373|NCT00545129|183458709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.46||0.988|TWO_SIDED|95.0|-0.95|0.94|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.94|-0.95|0.988
91612314|NCT02345161|183118779|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.75||0.253|TWO_SIDED|95.0|-2.3|0.6|||Mixed Model Repeated Measures||Week 52, DBP|||0.6|-2.3|0.253
91612315|NCT02345161|183118781|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.526|TWO_SIDED|95.0|-0.6|1.2|||Mixed Model Repeated Measures|||||1.2|-0.6|0.526
91612316|NCT02345161|183118782|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.96||0.007|TWO_SIDED|95.0|0.7|4.5|||Mixed Model Repeated Measures|||||4.5|0.7|0.007
91612317|NCT00972244|183118822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.0987|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.28|-0.67|<0.0001
91654683|NCT00601484|183201734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-27.96|STANDARD_ERROR_OF_MEAN|10.059|||TWO_SIDED|90.0|-44.846|-11.075||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-11.075|-44.846|
91654684|NCT00601484|183201734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-25.72|STANDARD_ERROR_OF_MEAN|11.508|||TWO_SIDED|90.0|-45.079|-6.369||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.369|-45.079|
91789374|NCT00545129|183458709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.47||0.922|TWO_SIDED|95.0|-1.01|0.92|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.92|-1.01|0.922
91654685|NCT00601484|183201734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.56|STANDARD_ERROR_OF_MEAN|12.157|||TWO_SIDED|90.0|-40.017|0.902||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.902|-40.017|
91789375|NCT00545129|183458710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.4||0.655|TWO_SIDED|95.0|-1.03|0.66|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.66|-1.03|0.655
91524039|NCT01216163|182923469|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.94||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.94|0.17|0.005
91524040|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.4|1.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.28|0.40|<0.001
91524041|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.27||||0.148|TWO_SIDED|95.0|-0.1|0.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.63|-0.10|0.148
91524042|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.57||||0.011|TWO_SIDED|95.0|0.13|1.02||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.02|0.13|0.011
91524043|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.68|2.99||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.99|1.68|<0.001
91524044|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.071|TWO_SIDED|95.0|-0.04|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|-0.04|0.071
91524045|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.19|2.5||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.50|1.19|<0.001
91524046|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.67|4.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.06|2.67|<0.001
91524047|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.77||||0.008|TWO_SIDED|95.0|0.2|1.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.33|0.20|0.008
91612318|NCT00972244|183118822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1009|<|0.0001|TWO_SIDED|95.0|-0.65|-0.26||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.26|-0.65|<0.0001
91612319|NCT00972244|183118822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.53|-0.92|<0.0001
91612320|NCT00972244|183118822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.1018|<|0.0001|TWO_SIDED|95.0|-0.99|-0.59||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.59|-0.99|<0.0001
91654686|NCT00601484|183201734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|11.124|||TWO_SIDED|90.0|-40.633|-3.171||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.171|-40.633|
91524048|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.91|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.91|<0.001
91654687|NCT00601484|183201735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-2.942|-0.057||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.057|-2.942|
91654688|NCT00601484|183201735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.08|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|90.0|-3.458|-0.705||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.705|-3.458|
91654689|NCT00601484|183201735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.13|STANDARD_ERROR_OF_MEAN|1.267|||TWO_SIDED|90.0|-4.265|-0.004||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.004|-4.265|
91654690|NCT00601484|183201735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.531|||TWO_SIDED|90.0|-4.029|1.124||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.124|-4.029|
91654691|NCT00601484|183201735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.293|||TWO_SIDED|90.0|-4.419|-0.063||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.063|-4.419|
91524049|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.92|4.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.43|2.92|<0.001
91524050|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.69||||0.028|TWO_SIDED|95.0|0.07|1.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.30|0.07|0.028
91524051|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.74|2.24|<0.001
91524052|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|2.9|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|2.90|<0.001
91524053|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.82||||0.02|TWO_SIDED|95.0|0.13|1.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.51|0.13|0.020
91524054|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.93|||<|0.001|TWO_SIDED|95.0|2.09|3.77||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.77|2.09|<0.001
91654692|NCT00601484|183201736|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.93|||||TWO_SIDED|90.0|-27.32|11.32||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||11.32|-27.32|
91654693|NCT00601484|183201736|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-17.9|||||TWO_SIDED|90.0|-42.04|4.37||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||4.37|-42.04|
91654694|NCT00601484|183201736|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-24.44|||||TWO_SIDED|90.0|-51.58|0.67||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||0.67|-51.58|
91710446|NCT01087203|183313570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.46||0.01|TWO_SIDED|95.0|-2.17|-0.3|||ANCOVA|||Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.30|-2.17|0.010
91710447|NCT01087203|183313570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.49||0.009|TWO_SIDED|95.0|-2.3|-0.34|||ANCOVA|||Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.34|-2.30|0.009
91789376|NCT00545129|183458710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.44||0.897|TWO_SIDED|95.0|-0.85|0.96|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.96|-0.85|0.897
91789377|NCT00545129|183458710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.798|TWO_SIDED|95.0|-0.93|1.2|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.20|-0.93|0.798
91524055|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|3.38|||<|0.001|TWO_SIDED|95.0|2.46|4.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.30|2.46|<0.001
91524056|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|1.01||||0.009|TWO_SIDED|95.0|0.26|1.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.76|0.26|0.009
91612321|NCT00972244|183118823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.08|STANDARD_ERROR_OF_MEAN|4.7589|<|0.0001|TWO_SIDED|95.0|-35.45|-16.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-16.70|-35.45|<0.0001
91612322|NCT00972244|183118823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.42|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-38.7|-20.14||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-20.14|-38.70|<0.0001
91612323|NCT00972244|183118823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.94|STANDARD_ERROR_OF_MEAN|4.7402|<|0.0001|TWO_SIDED|95.0|-42.28|-23.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-23.60|-42.28|<0.0001
91612324|NCT00972244|183118823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.37|STANDARD_ERROR_OF_MEAN|4.8358|<|0.0001|TWO_SIDED|95.0|-50.9|-31.85||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-31.85|-50.90|<0.0001
91612325|NCT00972244|183118824|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-9.1|7.6||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||7.6|-9.1|1.0000
91612326|NCT00972244|183118824|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.2057|TWO_SIDED|95.0|-2.3|18.8||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||18.8|-2.3|0.2057
91612327|NCT00972244|183118824|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2||||0.6203|TWO_SIDED|95.0|-6.2|13.2||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||13.2|-6.2|0.6203
91710448|NCT01087203|183313570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.52||0.015|TWO_SIDED|95.0|-2.36|-0.27|||ANCOVA|||Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.27|-2.36|0.015
91710449|NCT03790865|183313629|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.025|TWO_SIDED||||||Mixed Models Analysis|||||||<0.025
91710450|NCT00502853|183313633|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Student's t-test|||Change from Baseline to Week 4||||0.1776
91710451|NCT00502853|183313633|SUPERIORITY_OR_OTHER|||||||0.1215|||||||Student's t-test|||Change from Baseline to Week 24||||0.1215
91710452|NCT00502853|183313633|SUPERIORITY_OR_OTHER||Slope|-0.1606|STANDARD_ERROR_OF_MEAN|0.1231||0.2246|||||||Random coefficient model|||Trend over time||||0.2246
91710453|NCT00502853|183313634|SUPERIORITY_OR_OTHER|||||||0.8989|||||||Student's t-test|||Change from Baseline to Week 4||||0.8989
91710454|NCT00502853|183313634|SUPERIORITY_OR_OTHER|||||||0.8834|||||||Student's t-test|||Change from Baseline to Week 24||||0.8834
91789378|NCT00545129|183458710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.51||0.672|TWO_SIDED|95.0|-0.83|1.27|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.27|-0.83|0.672
91612328|NCT00972244|183118824|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.7||||0.205|TWO_SIDED|95.0|-2.0|19.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||19.5|-2.0|0.2050
91612329|NCT00907881|183118847|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Regression, Linear|Pearson correlation coefficient||||||0.0002
91612330|NCT01097616|183118851|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.6|||<|1e-05|TWO_SIDED|95.0|12.0|27.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.1|12.0|<0.00001
91612331|NCT01097616|183118852|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||<|1e-05|TWO_SIDED|95.0|11.9|27.6||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.6|11.9|<0.00001
91654695|NCT00601484|183201736|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.5|||||TWO_SIDED|90.0|-41.71|17.33||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||17.33|-41.71|
91654696|NCT00601484|183201736|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-21.37|||||TWO_SIDED|90.0|-54.76|7.92||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||7.92|-54.76|
91710455|NCT00502853|183313634|SUPERIORITY_OR_OTHER||Slope|0.1357|STANDARD_ERROR_OF_MEAN|0.9051||0.8841|||||||Random coefficient model|||Trend over time||||0.8841
91789379|NCT00545129|183458710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.48||0.243|TWO_SIDED|95.0|-1.56|0.41|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.41|-1.56|0.243
91654697|NCT00601484|183201737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165|||TWO_SIDED|90.0|-0.591|-0.04||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.040|-0.591|
91654698|NCT00601484|183201737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|90.0|-0.734|0.02||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.020|-0.734|
91654699|NCT00601484|183201737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.211|||TWO_SIDED|90.0|-0.724|-0.015||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.015|-0.724|
91654700|NCT00601484|183201737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|90.0|-0.806|-0.005||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.005|-0.806|
91654701|NCT00601484|183201737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|90.0|-0.47|0.223||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.223|-0.470|
91710456|NCT00502853|183313635|SUPERIORITY_OR_OTHER|||||||0.5911|||||||Student's t-test|||Change from Baseline to Week 4||||0.5911
91710457|NCT00502853|183313635|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Student's t-test|||Change from Baseline to Week 24||||0.1475
91710458|NCT00502853|183313635|SUPERIORITY_OR_OTHER||Slope|0.1786|STANDARD_ERROR_OF_MEAN|0.1123||0.1463|||||||Random coefficient model|||Trend over time||||0.1463
91710459|NCT00502853|183313636|SUPERIORITY_OR_OTHER|||||||0.1101|||||||Student's t-test|||Change from Baseline at Week 4||||0.1101
91710460|NCT00502853|183313636|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Student's t-test|||Change from Baseline at Week 12||||0.0003
91789380|NCT00545129|183458711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.41||0.445|TWO_SIDED|95.0|-1.16|0.52|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.52|-1.16|0.445
91789381|NCT00545129|183458711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.992|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.00|-1.00|0.992
91789382|NCT00545129|183458711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.53||0.655|TWO_SIDED|95.0|-1.34|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.34|0.655
91789383|NCT00545129|183458711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.86|TWO_SIDED|95.0|-1.09|1.3|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.30|-1.09|0.860
91612332|NCT01097616|183118853|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.3|||<|1e-05|TWO_SIDED|95.0|-33.5|-19.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-19.2|-33.5|<0.00001
91612333|NCT01097616|183118854|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-22.9|||<|1e-05|TWO_SIDED|95.0|-30.3|-15.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-15.4|-30.3|<0.00001
91612334|NCT01097616|183118855|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.4||||0.00298|TWO_SIDED|95.0|-12.3|-2.5||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-2.5|-12.3|0.00298
91612335|NCT01097616|183118856|SUPERIORITY_OR_OTHER||[Difference in Least Squares Means|-8.4||||0.00019|TWO_SIDED|95.0|-12.8|-4.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.0|-12.8|0.00019
91612336|NCT01097616|183118857|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-11.2||||2e-05|TWO_SIDED|95.0|-16.3|-6.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.1|-16.3|0.00002
91612337|NCT01097616|183118858|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.4||||0.00037|TWO_SIDED|95.0|-14.6|-4.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.3|-14.6|0.00037
91612338|NCT01097616|183118859|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|13.6||||7e-05|TWO_SIDED|95.0|6.9|20.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||20.3|6.9|0.00007
91612339|NCT01097616|183118859|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|21.4|||<|1e-05|TWO_SIDED|95.0|15.5|27.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||27.4|15.5|<0.00001
91789384|NCT00545129|183458711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.59||0.595|TWO_SIDED|95.0|-1.52|0.89|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.89|-1.52|0.595
91789385|NCT00545129|183458712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.179|TWO_SIDED|95.0|-1.76|0.35|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.35|-1.76|0.179
91524057|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.46|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.46|<0.001
91524058|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|3.24|||<|0.001|TWO_SIDED|95.0|2.3|4.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.19|2.30|<0.001
91524059|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|1.08||||0.006|TWO_SIDED|95.0|0.31|1.85||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.85|0.31|0.006
91524060|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.16|||<|0.001|TWO_SIDED|95.0|1.22|3.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.10|1.22|<0.001
91524061|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||<|0.001|TWO_SIDED|95.0|1.51|3.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.43|1.51|<0.001
91524062|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.7||||0.08|TWO_SIDED|95.0|-0.09|1.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.49|-0.09|0.080
91524063|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|1.77|||<|0.001|TWO_SIDED|95.0|0.81|2.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.73|0.81|<0.001
91524064|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|1.41|3.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.37|1.41|<0.001
91524065|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|0.85||||0.037|TWO_SIDED|95.0|0.05|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.05|0.037
91524066|NCT01216163|182923470|SUPERIORITY_OR_OTHER||LS mean difference|1.54||||0.002|TWO_SIDED|95.0|0.57|2.52||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.52|0.57|0.002
91524067|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.88|2.88||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.88|1.88|<0.001
91524068|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.007|TWO_SIDED|95.0|0.15|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|0.15|0.007
91524069|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.32|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.32|<0.001
91524070|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.85|4.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.49|2.85|<0.001
91524071|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.004|TWO_SIDED|95.0|0.31|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.31|0.004
91789386|NCT00545129|183458712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.938|TWO_SIDED|95.0|-1.02|1.1|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.10|-1.02|0.938
91710461|NCT00502853|183313636|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
91612340|NCT01097616|183118860|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|16.3||||0.00016|TWO_SIDED|95.0|7.9|24.8|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||24.8|7.9|0.00016
91612341|NCT01097616|183118861|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|10.7||||0.01711|TWO_SIDED|95.0|1.9|19.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||19.5|1.9|0.01711
91612342|NCT01097616|183118862|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-32.5|||<|1e-05|TWO_SIDED|95.0|-39.3|-25.7|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-25.7|-39.3|<0.00001
91612343|NCT01097616|183118862|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-38.4|||<|1e-05|TWO_SIDED|95.0|-44.5|-32.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-32.3|-44.5|<0.00001
91612344|NCT01097616|183118863|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.4|||<|1e-05|TWO_SIDED|95.0|-34.3|-18.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-18.4|-34.3|<0.00001
91612345|NCT01097616|183118864|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.6||||9e-05|TWO_SIDED|95.0|-24.8|-8.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-8.3|-24.8|0.00009
91612346|NCT01097616|183118865|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.6||||0.01564|TWO_SIDED|95.0|-10.2|-1.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-1.1|-10.2|0.01564
91524072|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.87|3.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.51|1.87|<0.001
91613838|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.107||||0.0062|TWO_SIDED|95.0|1.029|1.191|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.191|1.029|0.0062
91613839|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.739||||0.0295|TWO_SIDED|95.0|0.563|0.97|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.563|0.0295
91613840|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.166|||<|0.0001|TWO_SIDED|95.0|0.083|0.329|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.329|0.083|<0.0001
91612347|NCT01097616|183118865|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.7||||0.00609|TWO_SIDED|95.0|-9.7|-1.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-1.6|-9.7|0.00609
91612348|NCT01097616|183118866|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.4||||0.05191|TWO_SIDED|95.0|-10.9|0.0|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||0.0|-10.9|0.05191
91612349|NCT01097616|183118867|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.2||||0.03771|TWO_SIDED|95.0|-10.2|-0.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-0.3|-10.2|0.03771
91612350|NCT01097616|183118870|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.6||||0.00041|TWO_SIDED|95.0|-14.9|-4.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.3|-14.9|0.00041
91612351|NCT01097616|183118870|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||2e-05|TWO_SIDED|95.0|-15.0|-5.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-5.5|-15.0|0.00002
91612352|NCT01097616|183118871|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||0.0004|TWO_SIDED|95.0|-16.0|-4.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.6|-16.0|0.00040
91612353|NCT01097616|183118872|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-8.1||||0.00606|TWO_SIDED|95.0|-13.8|-2.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-2.3|-13.8|0.00606
91654702|NCT00601484|183201738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.34|STANDARD_ERROR_OF_MEAN|8.425|||TWO_SIDED|90.0|-29.468|-1.209||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-1.209|-29.468|
91612354|NCT02677701|183118873|SUPERIORITY||Mean Difference (Net)|3.44||||0.0846|TWO_SIDED|95.0|-0.48|7.35|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||7.35|-0.48|0.0846
91612355|NCT02677701|183118874|SUPERIORITY||Mean Difference (Net)|1.31||||0.51|TWO_SIDED|95.0|-2.64|5.26|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||5.26|-2.64|0.51
91612356|NCT02677701|183118875|SUPERIORITY||Mean Difference (Net)|-2.89||||0.17|TWO_SIDED|95.0|-7.01|1.22|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||1.22|-7.01|0.17
91612357|NCT02677701|183118876|SUPERIORITY||Mean Difference (Net)|1.53||||0.56|TWO_SIDED|95.0|-3.7|6.77||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||6.77|-3.70|0.56
91612358|NCT02677701|183118877|SUPERIORITY||Mean Difference (Net)|0.75||||0.043|TWO_SIDED|95.0|0.03|1.47||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||1.47|0.03|0.043
91612359|NCT02487745|183118888|SUPERIORITY||Odds Ratio (OR)|2.29||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
91612360|NCT02487745|183118889|SUPERIORITY||Odds Ratio (OR)|3.88||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
91654703|NCT00601484|183201738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|11.102|||TWO_SIDED|90.0|-35.608|1.665||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.665|-35.608|
91612361|NCT00532883|183118900|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||This is a global test comparing all four treatment arms.|Mixed Models Analysis|||F-test from a longitudinal mixed model (controlling for baseline measurement)testing the hypothesis of no difference in mean percent dense cells between the four treatment groups at Visit 6. The study was originally powered to detect a difference of 20%, but it was stopped early.||||0.93
91654704|NCT00601484|183201738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.358|||TWO_SIDED|90.0|-35.476|-0.613||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.613|-35.476|
91612362|NCT01214434|183118904|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
91612363|NCT01214434|183118906|SUPERIORITY_OR_OTHER||||||=|0.03||95.0|||||t-test, 2 sided|||||||=0.03
91612364|NCT01214434|183118907|SUPERIORITY_OR_OTHER||||||=|0.6||95.0|||||t-test, 2 sided|||||||=0.6
91612365|NCT01214434|183118908|SUPERIORITY_OR_OTHER||||||=|0.24||95.0|||||t-test, 2 sided|||||||=.24
91612366|NCT01214434|183118909|SUPERIORITY_OR_OTHER||||||=|0.8||95.0|||||t-test, 2 sided|||||||=0.8
91654705|NCT00601484|183201738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.48|STANDARD_ERROR_OF_MEAN|13.631|||TWO_SIDED|90.0|-42.418|3.46||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.460|-42.418|
91612367|NCT02075255|183118911|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.7|50.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate is used.|||50.00|16.70|<0.001
91789387|NCT00545129|183458712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-1.41|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.41|0.621
91612368|NCT02075255|183118911|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|37.5|||<|0.001|TWO_SIDED|95.0|20.8|50.0|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||50.00|20.80|<0.001
91612369|NCT02075255|183118912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.22|7.57|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.57|2.22|<0.001
91612370|NCT02075255|183118912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.001|TWO_SIDED|95.0|2.22|7.63|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.63|2.22|<0.001
91612371|NCT02075255|183118913|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
91612372|NCT02075255|183118913|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
91612373|NCT02075255|183118914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.79|7.22|||Cochran-Mantel-Haenszel|Controlling for region.||||7.22|1.79|<0.001
91612374|NCT02075255|183118914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.57|5.86|||Cochran-Mantel-Haenszel|Controlling for region.||||5.86|1.57|<0.001
91612375|NCT02075255|183118915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|1.92|14.21|||Cochran-Mantel-Haenszel|Controlling for region.||||14.21|1.92|<0.001
91612376|NCT02075255|183118915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.58|11.12|||Cochran-Mantel-Haenszel|Controlling for region.||||11.12|1.58|0.002
91612377|NCT02075255|183118916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.012|TWO_SIDED|95.0|0.21|0.83|||Cochran-Mantel-Haenszel|Controlling for region.||||0.83|0.21|0.012
91612378|NCT02075255|183118916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.053|TWO_SIDED|95.0|0.27|1.01|||Cochran-Mantel-Haenszel|Controlling for region.||||1.01|0.27|0.053
91612379|NCT02075255|183118917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.6|6.23|||Cochran-Mantel-Haenszel|Controlling for region.||||6.23|1.60|<0.001
91612380|NCT02075255|183118917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.002|TWO_SIDED|95.0|1.41|5.31|||Cochran-Mantel-Haenszel|Controlling for region.||||5.31|1.41|0.002
91612381|NCT02075255|183118918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.001|TWO_SIDED|95.0|0.16|0.65|||Cochran-Mantel-Haenszel|Controlling for region.||||0.65|0.16|0.001
91612382|NCT02075255|183118918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.001|TWO_SIDED|95.0|0.14|0.56|||Cochran-Mantel-Haenszel|Controlling for region.||||0.56|0.14|<0.001
91612383|NCT02075255|183118919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.66|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.66|0.22|<0.001
91612384|NCT02075255|183118919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.57|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.57|0.17|<0.001
91612385|NCT02075255|183118920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.291|TWO_SIDED|95.0|0.14|1.64|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||1.64|0.14|0.291
91612386|NCT02075255|183118920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12||||0.042|TWO_SIDED|95.0|0.01|0.63|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||0.63|0.01|0.042
91612387|NCT02075255|183118921|SUPERIORITY_OR_OTHER||Rate ratio|0.45||||0.003|TWO_SIDED|95.0|0.27|0.76|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.76|0.27|0.003
91612388|NCT02075255|183118921|SUPERIORITY_OR_OTHER||Rate ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.17|0.53|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.53|0.17|<0.001
91612389|NCT02075255|183118922|SUPERIORITY_OR_OTHER||Rate ratio|0.44||||0.187|TWO_SIDED|95.0|0.13|1.49|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||1.49|0.13|0.187
91612390|NCT02075255|183118922|SUPERIORITY_OR_OTHER||Rate ratio|0.07||||0.018|TWO_SIDED|95.0|0.01|0.63|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||0.63|0.01|0.018
91789388|NCT00545129|183458712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.64||0.863|TWO_SIDED|95.0|-1.44|1.21|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.21|-1.44|0.863
91789389|NCT00545129|183458712|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.59||0.237|TWO_SIDED|95.0|-1.95|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.51|-1.95|0.237
91789390|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
91789391|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
91789392|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
91612391|NCT02075255|183118924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.153|TWO_SIDED|95.0|-0.04|0.251|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.251|-0.040|0.153
91612392|NCT02075255|183118924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112||||0.129|TWO_SIDED|95.0|-0.033|0.258|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.258|-0.033|0.129
91612393|NCT02075255|183118925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.35|0.32|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.32|-0.35|0.947
91612394|NCT02075255|183118925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.291|TWO_SIDED|95.0|-0.51|0.16|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.16|-0.51|0.291
91612395|NCT02075255|183118926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.18|-0.18|0.998
91612396|NCT02075255|183118926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.177|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.05|-0.30|0.177
91612397|NCT02075255|183118927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|-0.17|0.17|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.17|-0.17|0.973
91612398|NCT02075255|183118927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.48|TWO_SIDED|95.0|-0.23|0.11|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.11|-0.23|0.480
91789393|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.601|TWO_SIDED|95.0|0.44|4.53|||Fisher Exact|||Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.53|0.44|0.601
91612399|NCT02075255|183118928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.397|TWO_SIDED|95.0|-1.44|0.57|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||0.57|-1.44|0.397
91612400|NCT02075255|183118928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||-0.41|-2.42|0.006
91612401|NCT02075255|183118929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.25||||0.143|TWO_SIDED|95.0|-6.58|45.07|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||45.07|-6.58|0.143
91612402|NCT02075255|183118929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.01||||0.023|TWO_SIDED|95.0|4.26|55.76|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||55.76|4.26|0.023
91612403|NCT02075255|183118930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19||||0.237|TWO_SIDED|95.0|-10.08|40.46|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||40.46|-10.08|0.237
91612404|NCT02075255|183118930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.52||||0.014|TWO_SIDED|95.0|6.32|56.71|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||56.71|6.32|0.014
91612405|NCT02075255|183118931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.742|TWO_SIDED|95.0|-0.08|0.11|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.11|-0.08|0.742
91612406|NCT02075255|183118931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.693|TWO_SIDED|95.0|-0.11|0.07|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.07|-0.11|0.693
91612407|NCT02075255|183118932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.139|TWO_SIDED|95.0|-0.55|0.08|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||0.08|-0.55|0.139
91612408|NCT02075255|183118932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001|TWO_SIDED|95.0|-0.86|-0.23|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||-0.23|-0.86|0.001
91612409|NCT02075255|183118933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.658|TWO_SIDED|95.0|0.592|2.295|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||2.295|0.592|0.658
91612410|NCT02075255|183118933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661||||0.155|TWO_SIDED|95.0|0.826|3.34|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||3.340|0.826|0.155
91612411|NCT02075255|183118934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.151|TWO_SIDED|95.0|-0.08|0.53|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.53|-0.08|0.151
91612412|NCT02075255|183118934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.004|TWO_SIDED|95.0|0.14|0.76|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.76|0.14|0.004
91710462|NCT00502853|183313636|SUPERIORITY_OR_OTHER||Slope|-2.0857|STANDARD_ERROR_OF_MEAN|0.4965||0.0023|||||||Random coefficient model|||Trend over time||||0.0023
91789394|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
91789395|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
91789396|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.596|TWO_SIDED|95.0|0.43|4.66|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.66|0.43|0.596
91612413|NCT02075255|183118935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.538||||0.22|TWO_SIDED|95.0|0.773|3.06|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.060|0.773|0.220
91612414|NCT02075255|183118935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.783||||0.108|TWO_SIDED|95.0|0.882|3.605|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.605|0.882|0.108
91612415|NCT02075255|183118939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-162.2|||<|0.001|TWO_SIDED|95.0|-220.1|-104.3|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit|Percent change|||-104.3|-220.1|<0.001
91612416|NCT02075255|183118939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.4|||<|0.001|TWO_SIDED|95.0|-217.9|-100.9|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.|Percent change|||-100.9|-217.9|<0.001
91612417|NCT00394914|183118997|SUPERIORITY_OR_OTHER|||||||0.973|||||||Cochran-Mantel-Haenszel|||||||0.973
91612418|NCT00394914|183118998|SUPERIORITY_OR_OTHER|||||||0.425|||||||Cochran-Mantel-Haenszel|||||||0.425
91612419|NCT00044044|183119011|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91612420|NCT00044044|183119012|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91612421|NCT00044044|183119013|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91612422|NCT00044044|183119014|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91612423|NCT02099799|183119015|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.189|TWO_SIDED||||||Mixed Models Analysis|||||||0.189
91612424|NCT02099799|183119016|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.572|TWO_SIDED||||||Mixed Models Analysis|||||||0.572
91612425|NCT02099799|183119017|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.799|TWO_SIDED||||||Mixed Models Analysis|||||||0.799
91612426|NCT02099799|183119018|SUPERIORITY||Mean Difference (Final Values)|1312.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91612427|NCT02099799|183119019|SUPERIORITY|||||||0.2265|||||||t-test, 2 sided|||||||0.2265
91612428|NCT02099799|183119020|SUPERIORITY|||||||0.8897|||||||t-test, 2 sided|||||||0.8897
91612429|NCT00465738|183119021|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe-Wilson confidence interval for the difference between the response rates of the groups was calculated. The lower bound of the Newcombe-Wilson CI for the difference of proportions was compared to the non-inferiority margin of -25%.|difference in response rates|10.6|||||TWO_SIDED|95.0|-4.4|24.9|||||difference in response rates = response rate for high volume dilution group (20 U/ml) - response rate for low volume dilution group (50 U/ml)|Null hypothesis: The response rate for the low volume dilution group (50 U/ml) is greater than the response rate for the high volume dilution group (20 U/ml).||24.9|-4.4|
91612430|NCT01863758|183119076|SUPERIORITY_OR_OTHER||Annualized number of bleeding episodes|3.13|||<|0.05|TWO_SIDED|95.0|2.56|3.8|||2-sided, 1-sample Poisson test||The annualized number of bleeding episodes in study GENA-01 was 49.36.|This study was considered as showing efficacy if the annualized number of bleeding episodes (BE) was reduced by 50% compared to the number of BEs observed in study GENA-01 (NCT00989196).||3.80|2.56|<0.05
91612431|NCT01863758|183119077|SUPERIORITY_OR_OTHER||Annualized number of spontaneous BEs|1.9|||<|0.05|TWO_SIDED|95.0|1.46|2.43|||2-sided, 1-sample Poisson test||The annualized number of spontaneous bleeding episodes in study GENA-01 was 32.23|This study was considered as showing efficacy if the annualized number of spontaneous bleeding episodes (BE) was reduced by 50% compared to the number of spontaneous BEs observed in study GENA-01 (NCT00989196).||2.43|1.46|<0.05
91612432|NCT02961764|183119081|SUPERIORITY||Odds Ratio (OR)|0.289|||<|0.001|TWO_SIDED|95.0|0.156|0.532|||Fisher Exact|||||0.532|0.156|<0.001
91612433|NCT02961764|183119082|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||0.005
91612434|NCT02961764|183119083|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|||||||0.050
91789397|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.552|TWO_SIDED|95.0|0.39|6.24|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.24|0.39|0.552
91612435|NCT02961764|183119085|SUPERIORITY|||||||0.002|||||||t-test, 1 sided|||||||0.002
91612436|NCT01663740|183119124|SUPERIORITY_OR_OTHER||Mean Difference|-40.166|STANDARD_ERROR_OF_MEAN|14.1387||0.0075|TWO_SIDED|95.0|-68.869|-11.463|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to EOT|||-11.463|-68.869|0.0075
91612437|NCT01663740|183119125|SUPERIORITY_OR_OTHER||Mean Difference|1.758|STANDARD_ERROR_OF_MEAN|2.646||0.5109|TWO_SIDED|95.0|-3.619|7.135|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to EOT|||7.135|-3.619|0.5109
91612438|NCT01663740|183119125|SUPERIORITY_OR_OTHER||Mean Difference|-1.051|STANDARD_ERROR_OF_MEAN|3.2058||0.7449|TWO_SIDED|95.0|-7.566|5.464|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to end of FU|||5.464|-7.566|0.7449
91612439|NCT01663740|183119126|SUPERIORITY_OR_OTHER||Mean Difference|2.869|STANDARD_ERROR_OF_MEAN|3.2934||0.394|TWO_SIDED|95.0|-4.001|9.739|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from EOT to end of FU|||9.739|-4.001|0.3940
91789398|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
91789399|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
91789400|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.73||||0.029|TWO_SIDED|95.0|1.04|14.32|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||14.32|1.04|0.029
91789401|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63||||0.143|TWO_SIDED|95.0|0.67|11.36|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||11.36|0.67|0.143
91612440|NCT01663740|183119127|SUPERIORITY_OR_OTHER||Mean Difference|0.155|STANDARD_ERROR_OF_MEAN|0.3687||0.6773|TWO_SIDED|95.0|-0.594|0.903|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Basline to EOT|||0.903|-0.594|0.6773
91612441|NCT01663740|183119127|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3343||0.7046|TWO_SIDED|95.0|-0.806|0.551|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Baseline to end of FU|||0.551|-0.806|0.7046
91612442|NCT01663740|183119128|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3684||0.7323|TWO_SIDED|95.0|-0.888|0.633|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from EOT to end of FU|||0.633|-0.888|0.7323
91612443|NCT01663740|183119129|SUPERIORITY_OR_OTHER||Mean Difference|51.267|STANDARD_ERROR_OF_MEAN|36.6869||0.1756|TWO_SIDED|95.0|-24.626|127.159|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from EOT to end of FU|||127.159|-24.626|0.1756
91612444|NCT01663740|183119130|SUPERIORITY_OR_OTHER||Mean Difference|-10.195|STANDARD_ERROR_OF_MEAN|19.5745||0.6058|TWO_SIDED|95.0|-49.934|29.543|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to end of FU|||29.543|-49.934|0.6058
91612445|NCT01663740|183119131|SUPERIORITY_OR_OTHER||Mean Difference|-21.828|STANDARD_ERROR_OF_MEAN|9.1214||0.0222|TWO_SIDED|95.0|-40.346|-3.311|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to EOT|||-3.311|-40.346|0.0222
91612446|NCT01663740|183119131|SUPERIORITY_OR_OTHER||Mean Difference|-9.802|STANDARD_ERROR_OF_MEAN|8.3702||0.2495|TWO_SIDED|95.0|-26.795|7.19|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to end of FU|||7.190|-26.795|0.2495
91612447|NCT01663740|183119132|SUPERIORITY_OR_OTHER||Mean Difference|-11.683|STANDARD_ERROR_OF_MEAN|12.2576||0.3505|TWO_SIDED|95.0|-37.039|13.674|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from EOT to end of FU|||13.674|-37.039|0.3505
91612448|NCT01663740|183119133|SUPERIORITY_OR_OTHER||Mean Difference|-5.741|STANDARD_ERROR_OF_MEAN|6.7578||0.4021|TWO_SIDED|95.0|-19.524|8.042|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to EOT|||8.042|-19.524|0.4021
91612449|NCT01663740|183119133|SUPERIORITY_OR_OTHER||Mean Difference|-1.854|STANDARD_ERROR_OF_MEAN|5.1817||0.7229|TWO_SIDED|95.0|-12.423|8.714|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to end of FU|||8.714|-12.423|0.7229
91612450|NCT01663740|183119134|SUPERIORITY_OR_OTHER||Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|7.7598||0.708|TWO_SIDED|95.0|-19.192|13.291|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from EOT to end of FU|||13.291|-19.192|0.7080
91612451|NCT01663740|183119135|SUPERIORITY_OR_OTHER||Mean Difference|-1.861|STANDARD_ERROR_OF_MEAN|1.6512||0.2673|TWO_SIDED|95.0|-5.213|1.491|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to EOT|||1.491|-5.213|0.2673
91612452|NCT01663740|183119135|SUPERIORITY_OR_OTHER||Mean Difference|-1.114|STANDARD_ERROR_OF_MEAN|1.6147||0.4949|TWO_SIDED|95.0|-4.392|2.164|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to end of FU|||2.164|-4.392|0.4949
91612453|NCT01663740|183119136|SUPERIORITY_OR_OTHER||Mean Difference|0.047|STANDARD_ERROR_OF_MEAN|1.51||0.9753|TWO_SIDED|95.0|-3.063|3.157|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from EOT to end of FU|||3.157|-3.063|0.9753
91612454|NCT01663740|183119137|SUPERIORITY_OR_OTHER||Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.6347||0.9053|TWO_SIDED|95.0|-1.214|1.366|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to EOT|||1.366|-1.214|0.9053
91654706|NCT00601484|183201738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.16|STANDARD_ERROR_OF_MEAN|10.097|||TWO_SIDED|90.0|-26.174|7.849||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.849|-26.174|
91654707|NCT00601484|183201739|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.404|||TWO_SIDED|90.0|-1.394|0.03||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.030|-1.394|
91654708|NCT00601484|183201739|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-1.149|0.468||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.468|-1.149|
91710463|NCT00502853|183313637|SUPERIORITY_OR_OTHER|||||||0.3358|||||||Student's t-test|||Change from Baseline at Week 4||||0.3358
91710464|NCT00502853|183313637|SUPERIORITY_OR_OTHER|||||||0.9158|||||||Student's t-test|||Change from Baseline at Week 24||||0.9158
91789402|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
91654709|NCT00601484|183201739|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.449|||TWO_SIDED|90.0|-1.443|0.156||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.156|-1.443|
91654710|NCT00601484|183201739|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.546|||TWO_SIDED|90.0|-1.046|0.931||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.931|-1.046|
91789403|NCT00545129|183458713|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
91789404|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
91612455|NCT01663740|183119137|SUPERIORITY_OR_OTHER||Mean Difference|-1.215|STANDARD_ERROR_OF_MEAN|0.4477||0.0104|TWO_SIDED|95.0|-2.125|-0.305|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to end of FU|||-0.305|-2.125|0.0104
91612456|NCT01663740|183119138|SUPERIORITY_OR_OTHER||Mean Difference|-1.065|STANDARD_ERROR_OF_MEAN|0.4057||0.0143|TWO_SIDED|95.0|-1.899|-0.231|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,\& pre-transplant dialysis duration as explanatory variables.|Change in LH level from EOT to end of FU|||-0.231|-1.899|0.0143
91612457|NCT01663740|183119139|SUPERIORITY_OR_OTHER||Mean Difference|2.541|STANDARD_ERROR_OF_MEAN|1.7274||0.1505|TWO_SIDED|95.0|-0.969|6.052|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to EOT|||6.052|-0.969|0.1505
91612458|NCT01663740|183119139|SUPERIORITY_OR_OTHER||Mean Difference|-0.983|STANDARD_ERROR_OF_MEAN|0.6739||0.1539|TWO_SIDED|95.0|-2.352|0.387|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to end of FU|||0.387|-2.352|0.1539
91612459|NCT01663740|183119140|SUPERIORITY_OR_OTHER||Mean Difference|-1.474|STANDARD_ERROR_OF_MEAN|0.8084||0.0798|TWO_SIDED|95.0|-3.136|0.188|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from EOT to end of FU|||0.188|-3.136|0.0798
91612460|NCT01663740|183119141|SUPERIORITY_OR_OTHER||Mean Difference|-0.104|STANDARD_ERROR_OF_MEAN|23.466||0.9965|TWO_SIDED|95.0|-47.792|47.585|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to EOT|||47.585|-47.792|0.9965
91612461|NCT01663740|183119141|SUPERIORITY_OR_OTHER||Mean Difference|15.272|STANDARD_ERROR_OF_MEAN|20.6031||0.4636|TWO_SIDED|95.0|-26.599|57.142|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to end of FU|||57.142|-26.599|0.4636
91612462|NCT01663740|183119142|SUPERIORITY_OR_OTHER||Mean Difference|8.74|STANDARD_ERROR_OF_MEAN|17.0805||0.6134|TWO_SIDED|95.0|-26.438|43.917|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from EOT to end of FU|||43.917|-26.438|0.6134
91612463|NCT01663740|183119143|SUPERIORITY_OR_OTHER||Mean Difference|8.142|STANDARD_ERROR_OF_MEAN|11.9301||0.5002|TWO_SIDED|95.0|-16.223|32.506|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to EOT|||32.506|-16.223|0.5002
91612464|NCT01663740|183119143|SUPERIORITY_OR_OTHER||Mean Difference|40.682|STANDARD_ERROR_OF_MEAN|17.6084||0.0279|TWO_SIDED|95.0|4.72|76.643|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to end of FU|||76.643|4.720|0.0279
91612465|NCT01663740|183119144|SUPERIORITY_OR_OTHER||Mean Difference|25.881|STANDARD_ERROR_OF_MEAN|22.1348||0.2548|TWO_SIDED|95.0|-20.024|71.786|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables|Change in inhibin B level from EOT to end of FU|||71.786|-20.024|0.2548
91612466|NCT01663740|183119145|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|95.0|-19.3|45.3|||||Change in abnormal to abnormal sperm density from Baseline to EOT|||45.3|-19.3|
91612467|NCT01663740|183119145|SUPERIORITY_OR_OTHER||Difference in Percentage|5.0|||||TWO_SIDED|95.0|-34.3|43.3|||||Change in abnormal to abnormal sperm density from Baseline to end of FU|||43.3|-34.3|
91612468|NCT01663740|183119145|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|95.0|-15.3|48.8|||||Change in normal to abnormal sperm density from Baseline to EOT|||48.8|-15.3|
91612469|NCT01663740|183119146|SUPERIORITY_OR_OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-34.5|42.5|||||Change in abnormal to abnormal sperm density from EOT to end of FU|||42.5|-34.5|
91612470|NCT01663740|183119147|SUPERIORITY_OR_OTHER||Difference in Percentage|1.3|||||TWO_SIDED|95.0|-31.3|33.7|||||Improvement from Baseline to EOT|||33.7|-31.3|
91654711|NCT00601484|183201739|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.673|||TWO_SIDED|90.0|-1.876|0.592||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.592|-1.876|
91710465|NCT00502853|183313637|SUPERIORITY_OR_OTHER||Slope|0.003418|STANDARD_ERROR_OF_MEAN|0.02345||0.8877|||||||Random coefficient model|||Trend over time||||0.8877
91789405|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
91789406|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
91710466|NCT00502853|183313638|SUPERIORITY_OR_OTHER|||||||0.7624|||||||Student's t-test|||Change from Baseline at Week 4||||0.7624
91789407|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.795|TWO_SIDED|95.0|0.38|3.88|||Fisher Exact|||Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.88|0.38|0.795
91612471|NCT01663740|183119147|SUPERIORITY_OR_OTHER||Difference in Percentage|6.7|||||TWO_SIDED|95.0|-31.1|44.4|||||Improvement from Baseline to end of FU|||44.4|-31.1|
91612472|NCT01663740|183119148|SUPERIORITY_OR_OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-50.0|29.3|||||Improvement from EOT to end of FU|||29.3|-50.0|
91612473|NCT01663740|183119149|SUPERIORITY_OR_OTHER||Difference in Percentage|-31.0|||||TWO_SIDED|95.0|-59.7|2.7|||||Improvement from Baseline to EOT|||2.7|-59.7|
91612474|NCT01663740|183119149|SUPERIORITY_OR_OTHER||Difference in Percentage|10.0|||||TWO_SIDED|95.0|-29.7|47.7|||||Improvement from Baseline to end of FU|||47.7|-29.7|
91612475|NCT01663740|183119150|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.9|||||TWO_SIDED|95.0|-47.2|27.9|||||Improvement from EOT to end of FU|||27.9|-47.2|
91612476|NCT02658656|183119160|SUPERIORITY||Risk Ratio (RR)|0.91||||0.798|TWO_SIDED|95.0|0.45|1.85|||Chi-squared|||||1.85|.45|0.798
91612477|NCT02658656|183119161|SUPERIORITY||Risk Ratio (RR)|0.97||||0.935|TWO_SIDED|95.0|0.44|2.15|||Chi-squared|||||2.15|0.44|0.935
91612478|NCT02658656|183119162|SUPERIORITY||Risk Ratio (RR)|0.93||||0.829|TWO_SIDED|95.0|0.49|1.79|||Chi-squared|||||1.79|0.49|0.829
91612479|NCT02658656|183119163|SUPERIORITY||Risk Ratio (RR)|1.09||||0.809|TWO_SIDED|95.0|0.56|2.11|||Chi-squared|||||2.11|0.56|0.809
91612480|NCT02658656|183119164|SUPERIORITY||Risk Ratio (RR)|1.15||||0.717|TWO_SIDED|95.0|0.54|2.47|||Chi-squared|||||2.47|0.54|0.717
91612481|NCT02658656|183119165|SUPERIORITY||Risk Ratio (RR)|1.11||||0.738|TWO_SIDED|95.0|0.61|2.02|||Chi-squared|||||2.02|0.61|0.738
91612482|NCT00128206|183119196|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.51|||>|0.05||95.0|0.13|2.01|||Chi-squared|||The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.||2.01|.13|>.05
91612483|NCT00408421|183119241|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).||||<0.001
91612484|NCT00408421|183119242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.001||95.0|-0.84|-0.21||Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|ANCOVA|||An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.||-0.21|-0.84|0.001
91612485|NCT00408421|183119243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.003||95.0|-2.33|-0.48||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.48|-2.33|0.003
91612486|NCT00408421|183119244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.004||95.0|-1.09|-0.22||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.22|-1.09|0.004
91710467|NCT00502853|183313638|SUPERIORITY_OR_OTHER|||||||0.0212|||||||Student's t-test|||Change from Baseline at Week 24||||0.0212
91710468|NCT00502853|183313638|SUPERIORITY_OR_OTHER||Slope|-4.2681|STANDARD_ERROR_OF_MEAN|2.0529||0.0712|||||||Random coefficient model|||Trend over time||||0.0712
91710469|NCT00502853|183313639|SUPERIORITY_OR_OTHER|||||||0.024|||||||Student's t-test|||Change from Baseline at Week 4||||0.0240
91710470|NCT00502853|183313639|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Student's t-test|||Change from Baseline at Week 12||||0.0045
91710471|NCT00502853|183313639|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
91789408|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
91789409|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
91789410|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||1|TWO_SIDED|95.0|0.33|3.39|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.39|0.33|1.000
91789411|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.771|TWO_SIDED|95.0|0.33|4.83|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.83|0.33|0.771
91789412|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
91524073|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|6.8|||<|0.001|TWO_SIDED|95.0|4.96|8.64||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||8.64|4.96|<0.001
91524074|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|2.09||||0.007|TWO_SIDED|95.0|0.59|3.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.59|0.59|0.007
91524075|NCT01216163|182923471|SUPERIORITY_OR_OTHER||LS mean difference|4.71|||<|0.001|TWO_SIDED|95.0|2.87|6.54||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.54|2.87|<0.001
91524076|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|3.81|||<|0.001|TWO_SIDED|95.0|3.05|4.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.57|3.05|<0.001
91524077|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|0.76||||0.016|TWO_SIDED|95.0|0.14|1.38||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.38|0.14|0.016
91524078|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.29|3.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.80|2.29|<0.001
91612487|NCT00408421|183119245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.18||||0.001||95.0|-8.33|-2.03||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.03|-8.33|0.001
91612488|NCT00408421|183119246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.42||||0.004||95.0|-10.72|-2.11||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.11|-10.72|0.004
91612489|NCT00408421|183119247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83||||0.005||95.0|-1.4|-0.25||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.25|-1.40|0.005
91612490|NCT00408421|183119248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||||||<0.001
91710472|NCT00502853|183313639|SUPERIORITY_OR_OTHER||Slope|-0.1964|STANDARD_ERROR_OF_MEAN|0.04524||0.0019|||||||Random Coefficient Model|||Trend over time||||0.0019
91710473|NCT00502853|183313640|SUPERIORITY_OR_OTHER||Slope|-6.6294|STANDARD_ERROR_OF_MEAN|1.8623||0.0074|||||||Random Coefficient Model|||Trend over time||||0.0074
91789413|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
91789414|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.187|TWO_SIDED|95.0|0.66|7.3|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.30|0.66|0.187
91524079|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|5.9|||<|0.001|TWO_SIDED|95.0|4.66|7.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.15|4.66|<0.001
91524080|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.01|TWO_SIDED|95.0|0.33|2.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.37|0.33|0.010
91524081|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|4.56|||<|0.001|TWO_SIDED|95.0|3.31|5.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.80|3.31|<0.001
91524082|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|10.88|||<|0.001|TWO_SIDED|95.0|8.05|13.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.70|8.05|<0.001
91524083|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|2.87||||0.015|TWO_SIDED|95.0|0.57|5.18||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|0.57|0.015
91524084|NCT01216163|182923472|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.001|TWO_SIDED|95.0|5.18|10.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||10.83|5.18|<0.001
91524085|NCT01216163|182923473|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||<|0.001|TWO_SIDED|95.0|4.96|7.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.43|4.96|<0.001
91524086|NCT01216163|182923473|SUPERIORITY_OR_OTHER||LS mean difference|1.33||||0.01|TWO_SIDED|95.0|0.32|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.33|0.32|0.010
91612491|NCT00408421|183119249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.039||95.0|-1.69|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.69|0.039
91612492|NCT00408421|183119250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.001||95.0|-0.56|-0.14||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.14|-0.56|0.001
91613841|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.0048|TWO_SIDED|95.0|1.015|1.084|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.084|1.015|0.0048
91710474|NCT00502853|183313640|SUPERIORITY_OR_OTHER|||||||0.1273|||||||Student's t-test|||Change from Baseline at Week 4||||0.1273
91710475|NCT00502853|183313640|SUPERIORITY_OR_OTHER|||||||0.0132|||||||Student's t-test|||Change from Baseline at Week 12||||0.0132
91710476|NCT00502853|183313640|SUPERIORITY_OR_OTHER|||||||0.1542|||||||Student's t-test|||Change from Baseline at Week 24||||0.1542
91710477|NCT00502853|183313641|SUPERIORITY_OR_OTHER|||||||0.1396|||||||Student's t-test|||Change from Baseline at Week 4||||0.1396
91789415|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.399|TWO_SIDED|95.0|0.48|6.43|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.43|0.48|0.399
91789416|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
91612493|NCT00408421|183119251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06|||<|0.001||95.0|-1.66|-0.46||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.46|-1.66|<0.001
91612494|NCT00408421|183119252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.004||95.0|-1.28|-0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.24|-1.28|0.004
91612495|NCT00408421|183119253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|||<|0.001||95.0|-1.52|-0.42||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.42|-1.52|<0.001
91710478|NCT00502853|183313641|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 12||||0.0050
91789417|NCT00545129|183458714|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
91789418|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.68||0.188|TWO_SIDED|95.0|0.77|3.73|||Negative binomial regression|||Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.73|0.77|0.188
91789419|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|0.85||0.207|TWO_SIDED|95.0|0.72|4.54|||Negative binomial regression|||Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.54|0.72|0.207
91613842|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.797||||0.0019|TWO_SIDED|95.0|2.136|28.458|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||28.458|2.136|0.0019
91789420|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|0.92||0.317|TWO_SIDED|95.0|0.6|4.93|||Negative binomial regression|||Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.93|0.60|0.317
91613843|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
91613844|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
91613845|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
91613846|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
91789421|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.7||0.554|TWO_SIDED|95.0|0.5|3.71|||Negative binomial regression|||Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.71|0.50|0.554
91789422|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.35||0.581|TWO_SIDED|95.0|0.32|1.89|||Negative binomial regression|||Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.89|0.32|0.581
91789423|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.26|1.43|||Negative binomial regression|||Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.43|0.26|0.252
91524087|NCT01216163|182923473|SUPERIORITY_OR_OTHER||LS mean difference|4.87|||<|0.001|TWO_SIDED|95.0|3.63|6.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.10|3.63|<0.001
91612496|NCT00408421|183119254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.003||95.0|-1.5|-0.32||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.32|-1.50|0.003
91612497|NCT00408421|183119255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.019||95.0|-1.3|-0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.12|-1.30|0.019
91612498|NCT00408421|183119256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.164||95.0|-0.97|0.17||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.17|-0.97|0.164
91612499|NCT00408421|183119257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.049||95.0|-1.25|0.0||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.00|-1.25|0.049
91654712|NCT00601484|183201740|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-34.25|STANDARD_ERROR_OF_MEAN|21.509|||TWO_SIDED|90.0|-72.879|4.375||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.375|-72.879|
91654713|NCT00601484|183201740|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-30.97|STANDARD_ERROR_OF_MEAN|24.418|||TWO_SIDED|90.0|-75.23|13.285||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||13.285|-75.230|
91654714|NCT00601484|183201740|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-37.18|STANDARD_ERROR_OF_MEAN|28.74|||TWO_SIDED|90.0|-90.62|16.265||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.265|-90.620|
91789424|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.31||0.365|TWO_SIDED|95.0|0.26|1.64|||Negative binomial regression|||Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.64|0.26|0.365
91789425|NCT00545129|183458716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.25||0.212|TWO_SIDED|95.0|0.25|1.36|||Negative binomial regression|||Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.36|0.25|0.212
91789426|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.215|TWO_SIDED|95.0|-0.13|0.55|||ANCOVA|||Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.13|0.215
91789427|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.947|TWO_SIDED|95.0|-0.45|0.42|||ANCOVA|||Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.42|-0.45|0.947
91612500|NCT00408421|183119258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.093||95.0|-1.1|0.08||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.08|-1.10|0.093
91612501|NCT00408421|183119259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.287||95.0|-0.82|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-0.82|0.287
91612502|NCT00408421|183119260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.033||95.0|-1.23|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.23|0.033
91612503|NCT00408421|183119261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78||||0.015||95.0|-1.4|-0.15||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.15|-1.40|0.015
91612504|NCT00408421|183119262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.029||95.0|-1.06|-0.06||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.06|-1.06|0.029
91612505|NCT00408421|183119263|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.033
91710479|NCT00502853|183313641|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 24||||0.0050
91789428|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.341|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.20|-0.56|0.341
91789429|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.24||0.18|TWO_SIDED|95.0|-0.83|0.17|||ANCOVA|||Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.17|-0.83|0.180
91789430|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.509|TWO_SIDED|95.0|-0.43|0.84|||ANCOVA|||Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.84|-0.43|0.509
91789431|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.767|TWO_SIDED|95.0|-0.62|0.82|||ANCOVA|||Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.82|-0.62|0.767
91789432|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.108|TWO_SIDED|95.0|-0.11|0.95|||ANCOVA|||Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.95|-0.11|0.108
91789433|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.37||0.28|TWO_SIDED|95.0|-1.26|0.41|||ANCOVA|||Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.41|-1.26|0.280
91789434|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.57||0.747|TWO_SIDED|95.0|-1.53|1.15|||ANCOVA|||Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.15|-1.53|0.747
91789435|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.991|TWO_SIDED|95.0|-0.87|0.88|||ANCOVA|||Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.88|-0.87|0.991
91612506|NCT00408421|183119264|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.075
91612507|NCT00408421|183119265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.088||95.0|-0.28|3.94||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.94|-0.28|0.088
91612508|NCT00408421|183119266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.87||||0.08||95.0|-0.22|3.96||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.96|-0.22|0.080
91612509|NCT00408421|183119267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||<|0.001||95.0|0.03|0.1||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.10|0.03|<0.001
91612510|NCT00408421|183119268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.641||95.0|-1.19|0.74||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.74|-1.19|0.641
91612511|NCT00408421|183119269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.193||95.0|-1.17|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-1.17|0.193
91654715|NCT00601484|183201740|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.77|STANDARD_ERROR_OF_MEAN|43.222|||TWO_SIDED|90.0|-74.604|86.142||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||86.142|-74.604|
91654716|NCT00601484|183201740|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.35|STANDARD_ERROR_OF_MEAN|70.862|||TWO_SIDED|90.0|-164.142|121.438||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||121.438|-164.142|
91654717|NCT00601484|183201743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.788|||TWO_SIDED|90.0|-2.562|0.081||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.081|-2.562|
91789436|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.27||0.335|TWO_SIDED|95.0|-0.41|0.99|||ANCOVA|||Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.99|-0.41|0.335
91789437|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.7||0.159|TWO_SIDED|95.0|-4.57|1.48|||ANCOVA|||Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.48|-4.57|0.159
91789438|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23||0.136|TWO_SIDED|95.0|-0.16|0.94|||ANCOVA|||Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.94|-0.16|0.136
91789439|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.37||0.186|TWO_SIDED|95.0|-3.46|5.9|||ANCOVA|||Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||5.90|-3.46|0.186
91789440|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.48||0.292|TWO_SIDED|95.0|-1.52|0.49|||ANCOVA|||Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.49|-1.52|0.292
91789441|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.38||0.225|TWO_SIDED|95.0|-0.34|1.3|||ANCOVA|||Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.30|-0.34|0.225
91612512|NCT00408421|183119270|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.003
91612513|NCT00408421|183119271|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.026
91612514|NCT00408421|183119272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.459||95.0|-1.32|2.92||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||2.92|-1.32|0.459
91612515|NCT00408421|183119273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.326||95.0|-1.1|3.28||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.28|-1.10|0.326
91612516|NCT00408421|183119274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.16||||0.069||95.0|-0.25|6.56||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||6.56|-0.25|0.069
91612517|NCT00408421|183119275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.107||95.0|-1.2|0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.12|-1.20|0.107
91612518|NCT02772965|183119276|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.08|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||||1.05|0.45|0.08
91612519|NCT02772965|183119277|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
91612520|NCT02772965|183119278|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.8||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
91654718|NCT00601484|183201743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.986|||TWO_SIDED|90.0|-2.782|0.535||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.535|-2.782|
91789442|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.36||0.517|TWO_SIDED|95.0|-0.58|1.07|||ANCOVA|||Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.07|-0.58|0.517
91789443|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-2.48|2.48|||ANCOVA|||Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||2.48|-2.48|1.000
91612521|NCT02772965|183119279|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
91612522|NCT02772965|183119280|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
91612523|NCT02772965|183119281|SUPERIORITY||Risk Ratio (RR)|0.71||||0.08|TWO_SIDED|95.0|0.49|1.04|||Chi-squared|||||1.04|0.49|0.08
91612524|NCT00494871|183119287|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.0|Hazard Ratio (HR)|1.11||||0.025|TWO_SIDED|95.0|0.87|1.42|||Regression, Cox|||||1.42|0.87|0.025
91612525|NCT00494871|183119288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.24|1.0||||||||1.00|0.24|
91612526|NCT00494871|183119289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.34|1.22||||||||1.22|0.34|
91710480|NCT00502853|183313641|SUPERIORITY_OR_OTHER||Slope|-0.2902|STANDARD_ERROR_OF_MEAN|0.07966||0.0054|||||||Random coefficient model|||Trend over time||||0.0054
91789444|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-1.01|-0.99|||ANCOVA|||Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.99|-1.01|<0.001
91524088|NCT01216163|182923473|SUPERIORITY_OR_OTHER||LS mean difference|9.58|||<|0.001|TWO_SIDED|95.0|7.54|11.61||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.61|7.54|<0.001
91612527|NCT00494871|183119290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.41|1.34||||||||1.34|0.41|
91612528|NCT00494871|183119291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.22|0.98||||||||0.98|0.22|
91612529|NCT00494871|183119292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.06|15.85||||||||15.85|0.06|
91612530|NCT00494871|183119293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||||TWO_SIDED|95.0|0.3|28.16||||||||28.16|0.30|
91612531|NCT00494871|183119294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.97|||||TWO_SIDED|95.0|0.6|14.7||||||||14.70|0.60|
91612532|NCT00494871|183119295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.16|1.4||||||||1.40|0.16|
91654719|NCT00601484|183201743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.036|0.819||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.819|-3.036|
91789445|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.43||0.362|TWO_SIDED|95.0|-0.75|1.63|||ANCOVA|||Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.63|-0.75|0.362
91612533|NCT00494871|183119296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.43|4.31||||||||4.31|0.43|
91612534|NCT00494871|183119297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.5|1.43||||||||1.43|0.50|
91654720|NCT00601484|183201743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.816|||TWO_SIDED|90.0|-1.534|1.221||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.221|-1.534|
91612535|NCT00494871|183119298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.92|1.56||||||||1.56|0.92|
91612536|NCT02435173|183119302|SUPERIORITY||Adjusted means difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06||0.0012|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|Treatment as a fixed effect and log10 transformed baseline SPD as a covariate.||||-0.11|-0.37|0.0012
91612537|NCT02435173|183119303|SUPERIORITY||Adjusted means difference|40.13|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|28.51|51.75|||ANCOVA|Treatment as a fixed effect and baseline as a covariate.||||51.75|28.51|<0.0001
91612538|NCT03088605|183119345|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|90.0|-0.7|0.0|||ANCOVA|||Change from Baseline. ANCOVA model includes baseline scores as a covariate||0|-0.7|0.02
91612539|NCT03088605|183119346|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0001|TWO_SIDED|90.0|-1.4|0.5|||ANCOVA|||Change form baseline. ANCOVA model includes baseline score as a covariate.||0.5|-1.4|0.0001
91612540|NCT03088605|183119347|SUPERIORITY||Mean Difference (Net)|-1.42||||0.03|TWO_SIDED|90.0|-2.36|-0.47|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||-0.47|-2.36|0.03
91612541|NCT03088605|183119348|SUPERIORITY||Mean Difference (Net)|0.199||||0.39|TWO_SIDED|90.0|-0.177|0.575|||ANCOVA|||Change from Baseline; ANCOVA model includes baseline score as a covariate.||0.575|-0.177|0.39
91612542|NCT03088605|183119349|SUPERIORITY||Mean Difference (Net)|0.2||||0.97|TWO_SIDED|90.0|-1.7|2.0|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||2.0|-1.7|0.97
91612543|NCT03088605|183119350|SUPERIORITY||Mean Difference (Net)|-0.23||||0.06|TWO_SIDED|90.0|-0.48|0.03|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||0.03|-0.48|0.06
91612544|NCT02639182|183119351|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||||0.983||||||The stratification factors were the ECOG PS at baseline and the number of prior systemic renal cell carcinoma (RCC) regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||||0.983
91612545|NCT02639182|183119352|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.|Hazard Ratio (HR)|1.423||||0.11|TWO_SIDED|95.0|0.924|2.192||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||2.192|0.924|0.110
91654721|NCT00601484|183201743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|90.0|-2.398|1.32||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.320|-2.398|
91789446|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|4.08||1|TWO_SIDED|95.0|-51.87|51.87|||ANCOVA|||Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||51.87|-51.87|1.000
91789447|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-3.3|-0.76|||ANCOVA|||Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.76|-3.30|0.031
91789448|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.15||0.886|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.32|-0.28|0.886
91789449|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.66|TWO_SIDED|95.0|-0.52|0.33|||ANCOVA|||Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.33|-0.52|0.660
91789450|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.238|TWO_SIDED|95.0|-0.54|0.14|||ANCOVA|||Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.14|-0.54|0.238
91654722|NCT00601484|183201744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.99|STANDARD_ERROR_OF_MEAN|6.718|||TWO_SIDED|90.0|-22.25|0.277||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.277|-22.250|
91612546|NCT02639182|183119353|SUPERIORITY||Odds Ratio (OR)|0.4||||0.062|TWO_SIDED|95.0|0.1|1.1||A Cochran-Mantel-Haenszel (CMH) analysis of the ORR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported.||||1.1|0.1|0.062
91612547|NCT02639182|183119354|SUPERIORITY||Hazard Ratio (HR)|0.376||||0.439||95.0|0.031|4.482||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||4.482|0.031|0.439
91612548|NCT02639182|183119355|SUPERIORITY|||||||0.746||||||Test conducted at a 2-sided significance level of 0.05. The stratification factors were the ECOG PS at baseline and number of prior systemic RCC regimens.|Log Rank|||||||0.746
91612549|NCT02639182|183119356|SUPERIORITY|A CMH analysis of the DCR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Odds Ratio (OR)|0.5||||0.152|TWO_SIDED|95.0|0.2|1.3||The stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported as a measure of relative treatment effect, along with its two-sided 95% CI.|Cochran-Mantel-Haenszel|||||1.3|0.2|0.152
91612550|NCT02546856|183119373|NON_INFERIORITY|For the hypothesis that the relative dose of BBs would reach 52% by the end of the study and using an equivalence margin of 7%, we would need 157 patients per group for an alpha level of significance of 0.05 and a statistical power of 80% (beta of 0.80).|Mean Difference (Final Values)|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.1|||t-test, 2 sided|||||22.1|7.5|<0.001
91654723|NCT00601484|183201744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.43|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|90.0|-23.001|6.132||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||6.132|-23.001|
91654724|NCT00601484|183201744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.14|STANDARD_ERROR_OF_MEAN|9.737|||TWO_SIDED|90.0|-24.602|8.327||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.327|-24.602|
91612551|NCT02546856|183119374|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|1.4||||0.52|TWO_SIDED|95.0|-3.33|6.32|||Chi-squared|||||6.32|-3.33|0.52
91612552|NCT02546856|183119375|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.1||||0.31|TWO_SIDED|95.0|-1.9|6.1|||Chi-squared|||||6.1|-1.9|0.31
91612553|NCT02546856|183119376|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.63||||0.85|TWO_SIDED|95.0|-7.1|5.85|||Chi-squared|||||5.85|-7.1|0.85
91654725|NCT00601484|183201744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|7.406|||TWO_SIDED|90.0|-13.948|11.04||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.040|-13.948|
91789451|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.14||0.36|TWO_SIDED|95.0|-0.42|0.16|||ANCOVA|||Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.16|-0.42|0.360
91612554|NCT02546856|183119377|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.12||||0.44|TWO_SIDED|95.0|-3.3|7.54|||Chi-squared|||||7.54|-3.3|0.44
91612555|NCT02546856|183119379|NON_INFERIORITY|equivalence margin of 5%|Difference in percentages|0.7||||0.56|TWO_SIDED|95.0|-1.6|3.04|||Chi-squared|||||3.04|-1.6|0.56
91612556|NCT02546856|183119383|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.07||||0.96|TWO_SIDED|95.0|-2.69|2.83|||t-test, 2 sided|||||2.83|-2.69|0.96
91612557|NCT02546856|183119384|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|16.47||||0.97|TWO_SIDED|95.0|-781.0|748.0|||t-test, 2 sided|||||748|-781|0.97
91654726|NCT00601484|183201744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.83|STANDARD_ERROR_OF_MEAN|9.352|||TWO_SIDED|90.0|-23.884|8.234||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.234|-23.884|
91654727|NCT00601484|183201745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.064|||||TWO_SIDED|90.0|1.709|15.007||||||Week 6: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||15.007|1.709|
91789452|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.278|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.54|-0.16|0.278
91789453|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.809|TWO_SIDED|95.0|-0.34|0.27|||ANCOVA|||Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.27|-0.34|0.809
91789454|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.944|TWO_SIDED|95.0|-0.35|0.38|||ANCOVA|||Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.38|-0.35|0.944
91789455|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.892|TWO_SIDED|95.0|-0.48|0.55|||ANCOVA|||Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.48|0.892
91612558|NCT02546856|183119385|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|7.28||||0.44|TWO_SIDED|95.0|-11.27|25.83|||t-test, 2 sided|||||25.83|-11.27|0.44
91612559|NCT02546856|183119387|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|-0.91||||0.75|TWO_SIDED|95.0|-6.63|4.81|||t-test, 2 sided|||||4.81|-6.63|0.75
91612560|NCT02546856|183119388|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.04||||0.2|TWO_SIDED|95.0|-0.2|0.28|||t-test, 2 sided|||||0.28|-0.2|0.20
91612561|NCT02546856|183119389|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|-5.5||||0.01|TWO_SIDED|95.0|-9.7|-1.4|||Chi-squared|||||-1.4|-9.7|0.01
91612562|NCT02546856|183119390|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.68||||0.71|TWO_SIDED|95.0|-4.2|2.87|||Chi-squared|Equivalence margin of 7%||||2.87|-4.2|0.71
91612563|NCT02546856|183119391|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|16.5|||<|0.001|TWO_SIDED|95.0|8.7|24.3|||t-test, 2 sided|||||24.3|8.7|<0.001
91612564|NCT02546856|183119392|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.9||||0.93|TWO_SIDED|95.0|-15.1|17.1|||t-test, 2 sided|||||17.1|-15.1|0.93
91612565|NCT02546856|183119393|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.5||||0.86|TWO_SIDED|95.0|-7.1|8.2|||t-test, 2 sided|||||8.2|-7.1|0.86
91612566|NCT04655586|183119413|SUPERIORITY|||||||0.4715||||||All rNAPc2 vs. Heparin|Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.4715
91612567|NCT04655586|183119414|SUPERIORITY|||||||0.1883|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.1883
91612568|NCT04655586|183119417|SUPERIORITY|||||||1|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||1.0
91612569|NCT04655586|183119418|SUPERIORITY|||||||0.0254|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0254
91612570|NCT04655586|183119419|SUPERIORITY|||||||0.0535|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0535
91612571|NCT04655586|183119420|SUPERIORITY|||||||0.83|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.8300
91612572|NCT05057988|183119465|OTHER|paired T test|Mean Difference (Net)|1.04|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|0.53|1.55|||t-test, 2 sided|||||1.55|0.53|<.001
91612573|NCT05057988|183119466|OTHER|Paired T test|Mean Difference (Net)|0.98|STANDARD_DEVIATION|8.17||0.208|TWO_SIDED|95.0|-1.42|3.37|||t-test, 2 sided|||||3.37|-1.42|.208
91612574|NCT05057988|183119467|OTHER|Paired T test|Mean Difference (Net)|0.86|STANDARD_DEVIATION|1.2|<|0.001|TWO_SIDED|95.0|0.52|1.2|||t-test, 2 sided|||||1.20|0.52|<.001
91612575|NCT05057988|183119468|OTHER|Paired t test|Mean Difference (Net)|0.81|STANDARD_DEVIATION|5.65||0.328|TWO_SIDED|95.0|-0.84|2.47|||t-test, 1 sided|||||2.47|-.84|.328
91612576|NCT05057988|183119469|OTHER|Paired T test|Mean Difference (Final Values)|2.71|STANDARD_DEVIATION|4.95|<|0.001|TWO_SIDED|95.0|1.26|4.16|||t-test, 1 sided|||||4.16|1.26|<.001
91612577|NCT05057988|183119470|OTHER|Paired T test|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|6.38||0.486|TWO_SIDED|95.0|-1.22|2.53|||t-test, 1 sided|||||2.53|-1.22|.486
91612578|NCT05057988|183119471|OTHER|Paired T test|Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|7.57||0.832|TWO_SIDED|95.0|-2.46|1.99|||t-test, 2 sided|||||1.99|-2.46|.832
91612579|NCT05057988|183119472|OTHER|Paired T test|Mean Difference (Net)|-0.43|STANDARD_DEVIATION|3.06||0.34|TWO_SIDED|95.0|-1.33|0.47|||t-test, 2 sided|||||0.47|-1.33|.340
91612580|NCT05057988|183119474|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.31||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|paired sample t test||paired sample t test||0.89|-0.34|0.370
91612581|NCT05057988|183119474|OTHER|Paired T test|Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.09||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|||||.89|-.34|.370
91654728|NCT00601484|183201745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.722|||||TWO_SIDED|90.0|0.756|9.795||||||Week 16: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||9.795|0.756|
91710481|NCT00502853|183313642|SUPERIORITY_OR_OTHER|||||||0.0254|||||||Student's t-test|||Change from Baseline at Week 4||||0.0254
91654729|NCT02928848|183201766|OTHER|||||||0.14||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-week) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in overall language ability, as measured by the Western Aphasia Battery Aphasia Quotient (WAB-AQ), that endures over time.||||0.14
91789456|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.884|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.39|0.884
91789457|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.919|TWO_SIDED|95.0|-0.26|0.28|||ANCOVA|||Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.28|-0.26|0.919
91612582|NCT03065530|183119510|OTHER||||||<|0.05|||||||Kruskal-Wallis|||The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.||||<0.05
91612583|NCT00479466|183119529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.6|||<|0.001|TWO_SIDED|95.0|-44.0|-17.3|||ANCOVA|||||-17.3|-44.0|<0.001
91612584|NCT00479466|183119529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6|||<|0.001|TWO_SIDED|95.0|-59.7|-33.4|||ANCOVA|||||-33.4|-59.7|<0.001
91612585|NCT00479466|183119529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1|||<|0.001|TWO_SIDED|95.0|-64.3|-38.0|||ANCOVA|||||-38.0|-64.3|<0.001
91612586|NCT00479466|183119529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.2|||<|0.001|TWO_SIDED|95.0|-74.6|-47.8|||ANCOVA|||||-47.8|-74.6|<0.001
91612587|NCT00479466|183119529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|||<|0.001|TWO_SIDED|95.0|-48.6|-22.4|||ANCOVA|||||-22.4|-48.6|<0.001
91612588|NCT00479466|183119530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.53|-0.76|||ANCOVA|||||-0.76|-1.53|<0.001
91612589|NCT00479466|183119530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|||<|0.001|TWO_SIDED|95.0|-1.91|-1.15|||ANCOVA|||||-1.15|-1.91|<0.001
91612590|NCT00479466|183119530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||<|0.001|TWO_SIDED|95.0|-2.07|-1.31|||ANCOVA|||||-1.31|-2.07|<0.001
91612591|NCT00479466|183119530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.45|-1.68|||ANCOVA|||||-1.68|-2.45|<0.001
91612592|NCT00479466|183119530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.7|-0.95|||ANCOVA|||||-0.95|-1.70|<0.001
91612593|NCT00479466|183119531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.8|||<|0.001|TWO_SIDED|95.0|-79.4|-34.3|||ANCOVA|||||-34.3|-79.4|<0.001
91612594|NCT00479466|183119531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||<|0.001|TWO_SIDED|95.0|-91.8|-48.2|||ANCOVA|||||-48.2|-91.8|<0.001
91612595|NCT00479466|183119531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.4|||<|0.001|TWO_SIDED|95.0|-109.4|-65.3|||ANCOVA|||||-65.3|-109.4|<0.001
91612596|NCT00479466|183119531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.6|||<|0.001|TWO_SIDED|95.0|-124.2|-79.1|||ANCOVA|||||-79.1|-124.2|<0.001
91612597|NCT00479466|183119531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.8|||<|0.001|TWO_SIDED|95.0|-82.7|-38.8|||ANCOVA|||||-38.8|-82.7|<0.001
91612598|NCT03626415|183119534|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|94.4|||||TWO_SIDED|90.0|62.96|141.55|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||141.55|62.96|
91612599|NCT03626415|183119534|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adusted Geometric Means|105.53|||||TWO_SIDED|90.0|70.38|158.24|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||158.24|70.38|
91612600|NCT03626415|183119535|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|133.33|||||TWO_SIDED|90.0|86.17|206.28|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||206.28|86.17|
91612601|NCT03626415|183119535|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|153.99|||||TWO_SIDED|90.0|99.52|238.25|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||238.25|99.52|
91612602|NCT03626415|183119536|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|75.94|||||TWO_SIDED|90.0|57.39|100.47|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||100.47|57.39|
91612603|NCT03626415|183119536|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|84.14|||||TWO_SIDED|90.0|63.59|111.33|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||111.33|63.59|
91612604|NCT03626415|183119537|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|95.74|||||TWO_SIDED|90.0|72.71|126.08|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||126.08|72.71|
91612605|NCT03626415|183119537|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|114.82|||||TWO_SIDED|90.0|87.19|151.2|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||151.20|87.19|
91612606|NCT02544984|183119545|SUPERIORITY|||||||0.473|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||The numbers of unscheduled clinic visits due to respiratory symptoms are compared.||||0.473
91710482|NCT00502853|183313642|SUPERIORITY_OR_OTHER|||||||0.0384|||||||Student's t-test|||Change from Baseline at Week 12||||0.0384
91710483|NCT00502853|183313642|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Student's t-test|||Change from Baseline at Week 24||||0.0271
91789458|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.19||0.752|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.33|0.752
91612607|NCT02544984|183119545|SUPERIORITY|||||||0.505|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared||||0.505
91654730|NCT02928848|183201767|OTHER|||||||0.02||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-weeks) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in naming ability, as measured by the naming subtest of the WAB, that endures over time.||||.02
91654731|NCT00663871|183201788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.59|TWO_SIDED|95.0|-0.27|0.19|||ANOVA|||||0.19|-0.27|0.59
91789459|NCT00545129|183458717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.715|TWO_SIDED|95.0|-0.34|0.24|||ANCOVA|||Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.24|-0.34|0.715
91612608|NCT02544984|183119545|SUPERIORITY|||||||0.047|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of emergency room visits are compared||||0.047
91654732|NCT00663871|183201789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05||||0.21|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|||||0.19|-0.24|0.21
91654733|NCT00663871|183201790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.92|TWO_SIDED|95.0|0.69|1.5||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Negative Affect scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||1.50|0.69|0.92
91654734|NCT00663871|183201791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.86|TWO_SIDED|95.0|-1.21|1.44||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||1.44|-1.21|0.86
91654735|NCT00663871|183201792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.31||||0.63|TWO_SIDED|95.0|-1.57|0.94||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.94|-1.57|0.63
91654736|NCT00663871|183201793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.32||||0.5|TWO_SIDED|95.0|-1.25|0.61||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.61|-1.25|0.50
91654737|NCT00663871|183201794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.33||||0.25|TWO_SIDED|95.0|-0.23|0.88||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.88|-0.23|0.25
91789460|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.47||0.666|TWO_SIDED|95.0|-0.77|1.18|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.77|0.666
91789461|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.49||0.745|TWO_SIDED|95.0|-0.86|1.18|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.86|0.745
91789462|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.48||0.749|TWO_SIDED|95.0|-1.14|0.83|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.83|-1.14|0.749
91654738|NCT00663871|183201795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.52|TWO_SIDED|95.0|-1.83|0.92||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.92|-1.83|0.52
91612609|NCT02544984|183119545|SUPERIORITY|||||||0.675|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of hospital admissions are compared||||0.675
91612610|NCT02544984|183119546|SUPERIORITY|||||||0.435|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||||||0.435
91612611|NCT01469013|183119577|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91612612|NCT01469013|183119579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.009
91612613|NCT05232097|183119597|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the median of differences of the rumination score before and after therapy equals 0.||||0.005
91654739|NCT00663871|183201796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.52|TWO_SIDED|95.0|0.67|2.24||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Type A personality scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||2.24|0.67|0.52
91654740|NCT00663871|183201797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.68|TWO_SIDED|95.0|-0.16|0.1||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.10|-0.16|0.68
91654741|NCT00663871|183201798|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.17||||0.16|TWO_SIDED|95.0|-0.41|0.07|||Mixed Models Analysis|||||0.07|-0.41|0.16
91654742|NCT00663871|183201799|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.24|0.14|||Mixed Models Analysis|||||0.14|-0.24|0.59
91612614|NCT05232097|183119598|OTHER|||||||0.11|||||||Chi-squared|||The null hypothesis is that the same number of patients has intragastric pressure peaks indicating rumination before and after therapy.||||0.11
91612615|NCT05232097|183119599|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: The differences of means of 15D before and after therapy equals 0.||||0.060
91612616|NCT05232097|183119600|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The median of differences of WHODAS 2.0 before and after therapy equals 0.||||0.865
91612617|NCT05232097|183119601|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis : the differences of median BDI before and after behavioral therapy equals 0.||||0.149
91612618|NCT05232097|183119602|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median of BAI before and after behavioral therapy equals 0.||||1.000
91612619|NCT05232097|183119603|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median weight before and after therapy equals 0.||||0.102
91654743|NCT00663871|183201800|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.06||||0.35|TWO_SIDED|95.0|-0.06|0.18|||Mixed Models Analysis|||||0.18|-0.06|0.35
91654744|NCT00663871|183201801|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.04||||0.74|TWO_SIDED|95.0|-0.18|0.25|||Mixed Models Analysis|||||0.25|-0.18|0.74
91654745|NCT00663871|183201802|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.1||||0.28|TWO_SIDED|95.0|-0.27|0.08|||Mixed Models Analysis|||||0.08|-0.27|0.28
91789463|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.5||0.794|TWO_SIDED|95.0|-1.16|0.9|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.90|-1.16|0.794
91612620|NCT01327339|183119623|SUPERIORITY_OR_OTHER||percentage of participants|5.9|||||TWO_SIDED|95.0|4.3|7.8|||||The estimated value represents the percentage of participants with an adverse event.|||7.8|4.3|
91612621|NCT01847547|183119651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||||95.0|0.64|1.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.70|0.64|
91654746|NCT00663871|183201803|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.15||||0.76|TWO_SIDED|95.0|-0.09|0.39|||Repeated Measures MANOVA|||||0.39|-0.09|0.76
91612622|NCT01847547|183119652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.69|1.36|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.36|0.69|
91612623|NCT01847547|183119653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||||95.0|0.62|2.45|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.45|0.62|
91612624|NCT01847547|183119654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||||95.0|0.15|0.59|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.59|0.15|
91612625|NCT01847547|183119655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||||95.0|0.15|0.67|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||0.67|0.15|
91612626|NCT01847547|183119656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||||95.0|0.09|0.84|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.84|0.09|
91654747|NCT00663871|183201804|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.06||||0.62|TWO_SIDED|95.0|-0.18|0.3|||Repeated Measures MANOVA|||||0.30|-0.18|0.62
91654748|NCT00663871|183201805|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.03||||0.42|TWO_SIDED|95.0|-0.21|0.26|||Repeated Measures MANOVA|||||0.26|-0.21|0.42
91654749|NCT00663871|183201806|SUPERIORITY_OR_OTHER_LEGACY||Standardized mean difference|-0.06||||0.54|TWO_SIDED|95.0|-0.3|0.18|||Repeated Measures MANOVA|Repeated Measures MANOVA||||0.18|-0.30|0.54
91654750|NCT00582309|183201809|NON_INFERIORITY_OR_EQUIVALENCE|Original Power Analysis: The expected differences in mean blood glucose concentration between groups are \> 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.|||||<|0.05|TWO_SIDED|95.0||||All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values \< 0.05.|ANOVA|||Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher's Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher's least significant difference method.||||<0.05
91612627|NCT01847547|183119657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.78|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.78|
91612628|NCT01847547|183119659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.48|1.14|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.14|0.48|
91612629|NCT01847547|183119660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||||95.0|0.47|2.2|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.20|0.47|
91612630|NCT01847547|183119661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||||95.0|0.21|1.98|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.98|0.21|
91612631|NCT01847547|183119662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.5|1.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.08|0.50|
91612632|NCT01847547|183119663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||||95.0|0.21|0.76|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.76|0.21|
91612633|NCT01847547|183119664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.58|1.55|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.55|0.58|
91654751|NCT00955747|183201821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.4|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.||||<0.05
91654752|NCT01497938|183201822|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%|Mean Difference (Final Values)|0.05|||||ONE_SIDED|97.5||0.15|||ANCOVA|||||0.15||
91612634|NCT01847547|183119665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|0.32|5.72|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||5.72|0.32|
91612635|NCT01847547|183119666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||||95.0|0.83|3.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.08|0.83|
91612636|NCT01847547|183119667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||||95.0|0.57|3.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.70|0.57|
91612637|NCT01847547|183119668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.67|1.35|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||1.35|0.67|
91654753|NCT01497938|183201823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-588.0|||<|0.025||95.0|||||ANCOVA|||||||<0.025
91710484|NCT00502853|183313642|SUPERIORITY_OR_OTHER||Slope|-4.7586|STANDARD_ERROR_OF_MEAN|1.5278||0.0124|||||||Random coefficient model|||Trend over time||||0.0124
91612638|NCT01847547|183119669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||||95.0|0.79|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.79|
91612639|NCT04392011|183119670|OTHER||AUC ratio (geometric mean)|1.39|||||TWO_SIDED|90.0|1.23|1.57||||||||1.57|1.23|
91612640|NCT04392011|183119671|OTHER||AUC ratio (geometric mean)|0.99|||||TWO_SIDED|90.0|0.83|1.19||||||||1.19|0.83|
91612641|NCT04392011|183119673|OTHER||Cmax ratio (midazolam)|1.5|||||TWO_SIDED|90.0|1.32|1.7||||||||1.70|1.32|
91612642|NCT04392011|183119673|OTHER||Cmax ratio (dextromethorphan)|0.96|||||TWO_SIDED|90.0|0.78|1.19||||||||1.19|0.78|
91612643|NCT04392011|183119675|OTHER||half-life ratio (dextromethorphan)|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||||1.08|0.92|
91654754|NCT03708211|183201824|OTHER||Ratio of geometric mean|0.9359|||||TWO_SIDED|90.0|0.8084|1.0835||||||Following log-transformation, PK parameters were analyzed by analysis of variance (ANOVA) fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90 percent (%) confidence intervals (CIs) for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.0835|0.8084|
91654755|NCT03708211|183201825|OTHER||Ratio of geometric mean|1.0036|||||TWO_SIDED|90.0|0.8992|1.1201||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1201|0.8992|
91654756|NCT03708211|183201826|OTHER||Ratio of geometric mean|1.0071|||||TWO_SIDED|90.0|0.9033|1.1227||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1227|0.9033|
91789464|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.772|TWO_SIDED|95.0|-1.33|1.0|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.33|0.772
91612644|NCT04392011|183119675|OTHER||half-life ratio (midazolam)|1.07|||||TWO_SIDED|90.0|0.98|1.17||||||||1.17|0.98|
91612645|NCT02795767|183119717|OTHER||ABR Ratio|0.01|||||TWO_SIDED|95.0|0.006|0.023|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.023|0.006|
91654757|NCT00097695|183201837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon version of the log-rank test|The Wilcoxon version of the log-rank test of SAS was used to calculate statistical significance between p- vs icatibant group and placebo group.||||||0.142
91654758|NCT00097695|183201838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon version of the log-rank test|The median time to onset is calculated using Kaplan-Meier methodology. The Wilcoxon version of the log-rank test of SAS is used.||||||< 0.001
91789465|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.5||0.547|TWO_SIDED|95.0|-0.73|1.34|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.34|-0.73|0.547
91789466|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.57||0.65|TWO_SIDED|95.0|-1.43|0.91|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-1.43|0.650
91612646|NCT02795767|183119718|OTHER||ABR Ratio|0.1|||||TWO_SIDED|95.0|0.051|0.21|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.210|0.051|
91612647|NCT01748760|183119753|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Chi-squared|||||||.87
91612648|NCT01855789|183119786|NON_INFERIORITY|Non-inferiority of TCZ + PBO was claimed if the upper bound of the 95% confidence interval (CI) for the mean difference was below 0.6.|Estimated Mean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.139|||TWO_SIDED|95.0|0.045|0.592||||||Analysis of covariance (ANCOVA) model included Week 24 DAS28 as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>/=100 kg qw), participant anti-tumor necrosis factor (anti-TNF) exposure (Yes/No).||0.592|0.045|
91612649|NCT01855789|183119787|SUPERIORITY||ACR 20 Response Rate Difference|-10.2||||0.0746|TWO_SIDED|95.0|-20.2|-0.2|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.2|-20.2|0.0746
91612650|NCT01855789|183119787|SUPERIORITY||ACR 20 Response Rate Difference|-8.8||||0.1159|TWO_SIDED|95.0|-19.3|1.6|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.6|-19.3|0.1159
91612651|NCT01855789|183119787|SUPERIORITY||ACR 20 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-15.8|-0.6|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.6|-15.8|
91612652|NCT01855789|183119788|SUPERIORITY||ACR 50 Response Rate Difference|-13.6||||0.0377|TWO_SIDED|95.0|-24.8|-2.4|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-2.4|-24.8|0.0377
91654759|NCT00097695|183201839|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.079||95.0|||||Wilcoxon version of the log-rank test|The median time to almost complete symptom relief was calculated using Kaplan-Meier methodology.The Wilcoxon version of the log-rank test of SAS used.||||||= 0.079
91789467|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|95.0|-1.27|1.0|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.27|0.808
91789468|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.55||0.915|TWO_SIDED|95.0|-1.19|1.07|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.07|-1.19|0.915
91789469|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.757|TWO_SIDED|95.0|-1.54|1.14|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.54|0.757
91789470|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.57||0.987|TWO_SIDED|95.0|-1.19|1.17|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.17|-1.19|0.987
91789471|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64||0.781|TWO_SIDED|95.0|-1.14|1.51|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.14|0.781
91789472|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.61||0.834|TWO_SIDED|95.0|-1.13|1.38|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.38|-1.13|0.834
91789473|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.59||0.851|TWO_SIDED|95.0|-1.32|1.1|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.10|-1.32|0.851
91789474|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.68||0.701|TWO_SIDED|95.0|-1.68|1.15|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.15|-1.68|0.701
91789475|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.59||0.453|TWO_SIDED|95.0|-1.68|0.77|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.68|0.453
91789476|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.67||0.258|TWO_SIDED|95.0|-2.15|0.6|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.60|-2.15|0.258
91789477|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.64||0.736|TWO_SIDED|95.0|-1.53|1.09|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.09|-1.53|0.736
91789478|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.64||0.491|TWO_SIDED|95.0|-1.76|0.87|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.87|-1.76|0.491
91654760|NCT05328375|183201841|OTHER||Mean|0.91|||||ONE_SIDED|95.0|0.62||||||The estimate is based on the number of participants enrolled per month over the 11-month recruitment period of the trial. A 1-sided 95% lower confidence limit was computed.||||0.62|
91654761|NCT05328375|183201842|OTHER||Mean|0.87|||||ONE_SIDED|95.0|0.66||||||The estimate is based on the mean proportion of cardiac rehabilitation sessions completed by THCR participants. A 1-sided 95% lower confidence limit was computed.||||0.66|
91654762|NCT05328375|183201843|OTHER||Proportion|1.0|||||ONE_SIDED|95.0|0.55||||||The estimate is based on the proportion of participants in the Telehealth-enhanced Hybrid CR arm who attended at least one cardiac rehabilitation session after randomization. A 1-sided 95% lower confidence limit was computed.||||0.55|
91654763|NCT05328375|183201843|OTHER||Proportion|1.0|||||ONE_SIDED|95.0|0.55||||||The estimate is based on the proportion of participants in the Traditional CR arm who attended at least one cardiac rehabilitation session after randomization. A 1-sided 95% lower confidence limit was computed.||||0.55|
91654764|NCT05328375|183201844|OTHER||Mean|0.69|||||ONE_SIDED|95.0|0.4||||||The estimate is based on the mean proportion of cardiac rehabilitation sessions completed by participants in the Traditional CR arm. A 1-sided 95% lower confidence limit was computed.||||0.40|
91789479|NCT00545129|183458718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.62||0.695|TWO_SIDED|95.0|-1.53|1.04|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.04|-1.53|0.695
91789480|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.6||0.897|TWO_SIDED|95.0|-1.34|1.19|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.19|-1.34|0.897
91789481|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.56||0.643|TWO_SIDED|95.0|-0.9|1.43|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.43|-0.90|0.643
91789482|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.464|TWO_SIDED|95.0|-1.45|0.68|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.68|-1.45|0.464
91789483|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.56||0.593|TWO_SIDED|95.0|-1.46|0.86|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.86|-1.46|0.593
91789484|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.423|TWO_SIDED|95.0|-1.77|0.77|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.77|0.423
91789485|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.805|TWO_SIDED|95.0|-1.21|1.54|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.54|-1.21|0.805
91789486|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.68||0.882|TWO_SIDED|95.0|-1.3|1.51|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.30|0.882
91789487|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.446|TWO_SIDED|95.0|-1.79|0.81|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.81|-1.79|0.446
91789488|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.68||0.604|TWO_SIDED|95.0|-1.77|1.05|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.05|-1.77|0.604
91789489|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.76||0.393|TWO_SIDED|95.0|-2.24|0.91|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-2.24|0.393
91789490|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.79||0.399|TWO_SIDED|95.0|-2.33|0.97|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.97|-2.33|0.399
91789491|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.75||0.876|TWO_SIDED|95.0|-1.43|1.66|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.66|-1.43|0.876
91789492|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.66||0.74|TWO_SIDED|95.0|-1.58|1.14|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.58|0.740
91789493|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.69||0.854|TWO_SIDED|95.0|-1.56|1.31|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.31|-1.56|0.854
91789494|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.78||0.436|TWO_SIDED|95.0|-2.24|1.0|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-2.24|0.436
91654765|NCT05328375|183201845|OTHER||Proportion|1.0|||||ONE_SIDED|95.0|0.55||||||Adequate feasibility was defined as a mean score ≥4 across four post-program items. A 1-sided 95% lower confidence limit was calculated.||||0.55|
91654766|NCT01893905|183201897|SUPERIORITY_OR_OTHER||||||<|0.0307|||||||Pocock approach|||||||<0.0307
91612653|NCT01855789|183119788|SUPERIORITY||ACR 50 Response Rate Difference|-15.0||||0.013|TWO_SIDED|95.0|-26.2|-3.7|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.7|-26.2|0.0130
91612654|NCT01855789|183119788|SUPERIORITY||ACR 50 Response Rate Difference|-10.9|||||TWO_SIDED|95.0|-21.4|-0.4|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.4|-21.4|
91612655|NCT01855789|183119789|SUPERIORITY||ACR 70 Response Rate Difference|-8.2||||0.3599|TWO_SIDED|95.0|-19.2|2.9|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||2.9|-19.2|0.3599
91612656|NCT01855789|183119789|SUPERIORITY||ACR 70 Response Rate Difference|-11.6||||0.0663|TWO_SIDED|95.0|-22.8|-0.3|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.3|-22.8|0.0663
91612657|NCT01855789|183119789|SUPERIORITY||ACR 70 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-19.4|3.1|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||3.1|-19.4|
91612658|NCT01855789|183119790|SUPERIORITY||DAS28 Worsening Rate Difference|7.5||||0.2371|TWO_SIDED|95.0|-2.4|17.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||17.3|-2.4|0.2371
91612659|NCT01855789|183119790|SUPERIORITY||DAS28 Worsening Rate Difference|3.4||||0.4811|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||13.7|-6.9|0.4811
91710485|NCT00502853|183313643|SUPERIORITY_OR_OTHER|||||||0.7376|||||||Student's t-test|||Change from Baseline at Week 4||||0.7376
91710486|NCT00502853|183313643|SUPERIORITY_OR_OTHER|||||||0.1631|||||||Student's t-test|||Change from Baseline at Week 12||||0.1631
91654767|NCT02708290|183201899|OTHER|Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.|Mean Difference (Final Values)|4.68|||<|0.0001|TWO_SIDED||||||Regression, Linear|||"The concept of a Visit was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis."||||<0.0001
91654768|NCT00976664|183201907|SUPERIORITY_OR_OTHER|||||||0.0007|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.||||||.0007
91654769|NCT00976664|183201907|SUPERIORITY_OR_OTHER|||||||0.3913|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.||||||.3913
91789495|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.087|TWO_SIDED|95.0|-2.81|0.21|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.21|-2.81|0.087
91789496|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.75||0.278|TWO_SIDED|95.0|-2.4|0.72|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.72|-2.40|0.278
91789497|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.69||0.548|TWO_SIDED|95.0|-1.84|1.0|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.84|0.548
91789498|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.75||0.318|TWO_SIDED|95.0|-2.33|0.79|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.79|-2.33|0.318
91789499|NCT00545129|183458719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73||0.484|TWO_SIDED|95.0|-2.02|0.99|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.99|-2.02|0.484
91789500|NCT00545129|183458720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1: P-value was calculated by Cochran-Mantel-Haenszel (CMH test) stratified by center.||||0.399
91789501|NCT00545129|183458720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: P-value was calculated by CMH test stratified by center.||||0.779
91789502|NCT00545129|183458720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.922|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: P-value was calculated by CMH test stratified by center.||||0.922
91789503|NCT00545129|183458720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.811|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6: P-value was calculated by CMH test stratified by center.||||0.811
91789504|NCT00545129|183458720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: P-value was calculated by CMH test stratified by center.||||0.237
91654770|NCT00976664|183201908|SUPERIORITY_OR_OTHER|||||||0.002|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.||||||.002
91654771|NCT00976664|183201908|SUPERIORITY_OR_OTHER|||||||0.0336|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.||||||.0336
91789505|NCT00545129|183458721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
91789506|NCT00545129|183458721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.202|TWO_SIDED|95.0|-0.7|0.16|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.16|-0.70|0.202
91789507|NCT00545129|183458721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.571|TWO_SIDED|95.0|-0.54|0.3|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.30|-0.54|0.571
91789508|NCT00545129|183458721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.808|TWO_SIDED|95.0|-0.55|0.43|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.43|-0.55|0.808
91654772|NCT02688400|183201912|NON_INFERIORITY|"Non-inferiority of Diacerein versus Celecoxib was assessed by computing the difference in the adjusted mean change from baseline (Visit 2) in WOMAC Pain subscale score after 182 days of treatment between Diacerein and Celecoxib treatment groups from a MMRM.~Assuming that:~* Non inferiority margin of 10 points for the absolute change in WOMAC Pain Subscale Score (scale 0-100)~* SD of 26 in the two treatment groups,~* Type I error: α = 0.025 (one-sided condition) and power equal to 90%"|Mean Difference (Final Values)|0.67|||<|0.025|ONE_SIDED|95.0||3.18||MMRM. Non-inferiority claim:Diacerein to be non-inferior to Celecoxib if upper bound of the the difference in the adjusted mean change was inferior to 5 cm on the PPS.|Mixed Models Analysis|||||3.18||<0.025
91654773|NCT02688400|183201913|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91654774|NCT02688400|183201914|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91789509|NCT00545129|183458721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.913|TWO_SIDED|95.0|-0.57|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.51|-0.57|0.913
91789510|NCT00545129|183458722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
91789511|NCT00545129|183458722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.21||0.339|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.23|-0.65|0.339
91612660|NCT01855789|183119791|SUPERIORITY||DAS28 Remission Rate Difference|-9.5||||0.1062|TWO_SIDED|95.0|-20.9|1.8|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.8|-20.9|0.1062
91612661|NCT01855789|183119791|SUPERIORITY||DAS28 Remission Rate Difference|-6.8||||0.3611|TWO_SIDED|95.0|-18.2|4.6|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||4.6|-18.2|0.3611
91612662|NCT01855789|183119792|SUPERIORITY||Low DAS28 Rate Difference|-13.6||||0.0228|TWO_SIDED|95.0|-24.0|-3.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.3|-24.0|0.0228
91612663|NCT01855789|183119792|SUPERIORITY||Low DAS28 Rate Difference|-5.4||||0.3665|TWO_SIDED|95.0|-16.3|5.4|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||5.4|-16.3|0.3665
91612664|NCT01855789|183119793|SUPERIORITY||Estimated Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.21|0.68|||||TCZ + PBO minus TCZ + MTX|ANCOVA model included Week 24 bone erosion as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), participant anti-TNF exposure (Yes/No), baseline weight-by-dosing group (\<80 kg q2w, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw).||0.68|-0.21|
91612665|NCT03625986|183119805|OTHER||Mean Difference (Final Values)|-186.68||||0.0039|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0039
91612666|NCT03625986|183119806|OTHER||Mean Difference (Final Values)|-0.06||||0.8103|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8103
91612667|NCT03625986|183119807|OTHER||Mean Difference (Final Values)|-3.14||||0.0105|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0105
91612668|NCT03625986|183119808|OTHER||Mean Difference (Final Values)|2415.93||||0.0182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0182
91612669|NCT03625986|183119809|OTHER||Mean Difference (Final Values)|1.18||||0.8429|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8429
91612670|NCT03625986|183119810|OTHER||Mean Difference (Final Values)|0.49||||0.4881|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4881
91612671|NCT03625986|183119811|OTHER||Mean Difference (Final Values)|1.76||||0.0835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0835
91654775|NCT02688400|183201915|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91612672|NCT03625986|183119812|OTHER||Mean Difference (Final Values)|-0.96||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
91612673|NCT03625986|183119813|OTHER||Odds Ratio (OR)|4.35||||0.0052|TWO_SIDED||||||Fisher Exact|||||||0.0052
91612674|NCT03625986|183119814|OTHER||Mean Difference (Final Values)|-1.95||||0.0797|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0797
91612675|NCT03625986|183119815|OTHER||Mean Difference (Final Values)|-1.44||||0.1084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1084
91612676|NCT03625986|183119816|OTHER||Mean Difference (Final Values)|3.81||||0.3469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3469
91612677|NCT03625986|183119817|OTHER||Odds Ratio (OR)|3.3632||||0.0272|TWO_SIDED||||||Fisher Exact|||||||0.0272
91612678|NCT03625986|183119818|OTHER||Mean Difference (Final Values)|0.6||||0.589|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.589
91612679|NCT03625986|183119819|OTHER||Mean Difference (Final Values)|-0.3||||0.5448|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5448
91612680|NCT03625986|183119820|OTHER||Mean Difference (Final Values)|15.3||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.65
91612681|NCT03625986|183119821|OTHER||Mean Difference (Final Values)|-4.0||||0.1567|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1567
91612682|NCT01850563|183119826|OTHER||Hazard Ratio (HR)|0.87||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
91612683|NCT01850563|183119828|OTHER||Hazard Ratio (HR)|0.82||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
91654776|NCT02688400|183201916|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
91654777|NCT02688400|183201917|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
91654778|NCT02688400|183201918|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91654779|NCT02688400|183201919|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91654780|NCT02688400|183201920|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91654781|NCT03068273|183201933|SUPERIORITY|||||||0.146|||||||Regression, Linear|||||||0.1460
91654782|NCT03068273|183201933|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91612684|NCT03151148|183119853|SUPERIORITY||Risk Ratio (RR)|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.06|0.29|0.075
91654783|NCT03068273|183201933|SUPERIORITY||Mean Difference (Net)|6.338|STANDARD_ERROR_OF_MEAN|4.331|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
91654784|NCT03068273|183201934|SUPERIORITY||Mean Difference (Net)|9.141|STANDARD_ERROR_OF_MEAN|4.838||0.0615|TWO_SIDED||||||Regression, Linear|||||||0.0615
91654785|NCT03068273|183201935|SUPERIORITY||Mean Difference (Net)|11.257|STANDARD_ERROR_OF_MEAN|4.775||0.0404|TWO_SIDED||||||Regression, Linear|||||||0.0404
91612685|NCT03151148|183119854|SUPERIORITY||Risk Difference (RD)|-0.28||||0.044|TWO_SIDED|95.0|-0.51|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.51|0.044
91612686|NCT03151148|183119855|SUPERIORITY||Risk Ratio (RR)|0.63||||0.121|TWO_SIDED|95.0|0.36|1.13|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.13|0.36|0.121
91612687|NCT03151148|183119856|SUPERIORITY||Risk Difference (RD)|-0.25||||0.053|TWO_SIDED|95.0|-0.46|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.46|0.053
91612688|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|2.76||||0.261|TWO_SIDED|95.0|0.469|16.226|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.226|0.469|0.261
91612689|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|0.41||||0.319|TWO_SIDED|95.0|0.069|2.393|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.393|0.069|0.319
91612690|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|1.02||||0.978|TWO_SIDED|95.0|0.174|6.027|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.027|0.174|0.978
91654786|NCT03068273|183201936|SUPERIORITY||Mean Difference (Net)|0.155|STANDARD_ERROR_OF_MEAN|0.354||0.268|TWO_SIDED||||||Regression, Linear|||||||0.2680
91789512|NCT00545129|183458722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.408|TWO_SIDED|95.0|-0.67|0.28|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.28|-0.67|0.408
91789513|NCT00545129|183458722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.27||0.686|TWO_SIDED|95.0|-0.67|0.45|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.45|-0.67|0.686
91612691|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|3.44||||0.177|TWO_SIDED|95.0|0.57|20.749|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.749|0.570|0.177
91654787|NCT03068273|183201937|SUPERIORITY||Mean Difference (Net)|-11.412|STANDARD_ERROR_OF_MEAN|4.839||0.0403|TWO_SIDED||||||Regression, Linear|||||||0.0403
91654788|NCT02207231|183201953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
91654789|NCT02207231|183201954|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
91654790|NCT02207231|183201955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
91654791|NCT02207231|183201955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
91654792|NCT02207231|183201956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
91654793|NCT02207231|183201956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
91654794|NCT02207231|183201957|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
91654795|NCT02207231|183201957|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
91654796|NCT02207231|183201958|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
91710487|NCT00502853|183313643|SUPERIORITY_OR_OTHER|||||||0.8816|||||||Student's t-test|||Change from Baseline at Week 24||||0.8816
91612692|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|1.7||||0.558|TWO_SIDED|95.0|0.288|9.973|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.973|0.288|0.558
91612693|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|1.04||||0.977|TWO_SIDED|95.0|0.082|13.151|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.151|0.082|0.977
91789514|NCT00545129|183458722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.3||0.493|TWO_SIDED|95.0|-0.81|0.4|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.40|-0.81|0.493
91612694|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|33.86||||0.007|TWO_SIDED|95.0|2.672|429.219|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||429.219|2.672|0.007
91612695|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|11.97||||0.055|TWO_SIDED|95.0|0.945|151.752|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||151.752|0.945|0.055
91612696|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|0.93||||0.957|TWO_SIDED|95.0|0.062|13.875|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.875|0.062|0.957
91612697|NCT03151148|183119861|SUPERIORITY||Geometric mean ratio (GMR)|1.78||||0.654|TWO_SIDED|95.0|0.141|22.607|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||22.607|0.141|0.654
91612698|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|2.722||||0.432|TWO_SIDED|95.0|0.2227|33.2594|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||33.2594|0.2227|0.432
91789515|NCT00545129|183458723|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
91789516|NCT00545129|183458723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.947|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract method.||||0.947
91789517|NCT00545129|183458723|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
91789518|NCT00545129|183458723|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
91789519|NCT00545129|183458723|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.759|TWO_SIDED|95.0|0.12|18.86|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||18.86|0.12|0.759
91789520|NCT00545129|183458724|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
91612699|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|0.147||||0.133|TWO_SIDED|95.0|0.0121|1.8018|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.8018|0.0121|0.133
91612700|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|0.371||||0.437|TWO_SIDED|95.0|0.0304|4.5392|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.5392|0.0304|0.437
91612701|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|1.247||||0.863|TWO_SIDED|95.0|0.1002|15.5231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.5231|0.1002|0.863
91612702|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|0.615||||0.702|TWO_SIDED|95.0|0.0503|7.5106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.5106|0.0503|0.702
91612703|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|0.465||||0.675|TWO_SIDED|95.0|0.0128|16.8576|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.8576|0.0128|0.675
91612704|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|32.638||||0.057|TWO_SIDED|95.0|0.8994|1184.4298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1184.4298|0.8994|0.057
91612705|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|11.539||||0.181|TWO_SIDED|95.0|0.318|418.7586|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||418.7586|0.3180|0.181
91654797|NCT02207231|183201959|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.9|25.7|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||25.7|12.9|< 0.001
91789521|NCT00545129|183458724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract test.||||0.950
91789522|NCT00545129|183458724|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
91710488|NCT00502853|183313643|SUPERIORITY_OR_OTHER||Slope|-0.2927|STANDARD_ERROR_OF_MEAN|1.9408||0.8835|||||||Random coefficient model|||Trend over time||||0.8835
91789523|NCT00545129|183458724|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
91789524|NCT00545129|183458724|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.578|TWO_SIDED|95.0|0.17|23.89|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||23.89|0.17|0.578
91789525|NCT04896229|183458763|SUPERIORITY||Slope|1.2|STANDARD_ERROR_OF_MEAN|0.52||0.022|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.022
91789526|NCT04896229|183458764|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.800
91789527|NCT04896229|183458765|SUPERIORITY||Slope|0.58|STANDARD_ERROR_OF_MEAN|0.49||0.235|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.235
91612706|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|0.895||||0.953|TWO_SIDED|95.0|0.0219|36.5559|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.5559|0.0219|0.953
91612707|NCT03151148|183119863|SUPERIORITY||Geometric mean ratio (GMR)|1.719||||0.767|TWO_SIDED|95.0|0.0474|62.3828|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||62.3828|0.0474|0.767
91612708|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|1.395||||0.488|TWO_SIDED|95.0|0.5429|3.5835|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.5835|0.5429|0.488
91654798|NCT02207231|183201959|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91654799|NCT02207231|183201960|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|24.1|||<|0.001|TWO_SIDED|95.0|17.0|31.0|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||31.0|17.0|< 0.001
91654800|NCT02207231|183201960|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91789528|NCT04896229|183458766|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.325|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.325
91789529|NCT04896229|183458767|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.502|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.502
91789530|NCT04896229|183458768|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.005|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.005
91612709|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|2.823||||0.03|TWO_SIDED|95.0|1.1038|7.221|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.2210|1.1038|0.030
91612710|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|2.077||||0.127|TWO_SIDED|95.0|0.8122|5.3135|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.3135|0.8122|0.127
91612711|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|0.789||||0.623|TWO_SIDED|95.0|0.3065|2.0331|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.0331|0.3065|0.623
91612712|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|0.627||||0.328|TWO_SIDED|95.0|0.245|1.6028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6028|0.2450|0.328
91612713|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|2.231||||0.242|TWO_SIDED|95.0|0.5799|8.5866|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.5866|0.5799|0.242
91612714|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|1.977||||0.321|TWO_SIDED|95.0|0.5137|7.6055|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.6055|0.5137|0.321
91612715|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|1.86||||0.366|TWO_SIDED|95.0|0.4833|7.1564|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.1564|0.4833|0.366
91612716|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|3.713||||0.068|TWO_SIDED|95.0|0.908|15.1856|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.1856|0.9080|0.068
91710489|NCT00502853|183313644|SUPERIORITY_OR_OTHER|||||||0.1312|||||||Student's t-test|||Change from Baseline at Week 4||||0.1312
91710490|NCT00502853|183313644|SUPERIORITY_OR_OTHER|||||||0.0662|||||||Student's t-test|||Change from Baseline at Week 12||||0.0662
91710491|NCT00502853|183313644|SUPERIORITY_OR_OTHER|||||||0.4133|||||||Student's t-test|||Change from Baseline at Week 24||||0.4133
91710492|NCT00502853|183313644|SUPERIORITY_OR_OTHER||Slope|8.8196|STANDARD_ERROR_OF_MEAN|16.4534||0.6049|||||||Random coefficient model|||Trend over time||||0.6049
91710493|NCT00502853|183313645|SUPERIORITY_OR_OTHER|||||||0.1725|||||||Student's t-test|||Change from Baseline at Week 4||||0.1725
91789531|NCT04896229|183458769|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.712|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.712
91789532|NCT04896229|183458770|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.245|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.245
91789533|NCT04896229|183458771|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.282|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.282
91789534|NCT04896229|183458772|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.289|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.289
91789535|NCT04896229|183458773|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.296|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.296
91789536|NCT00992589|183458782|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.449||||0.168|TWO_SIDED|95.0|-1.087|0.19|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in daily average frequency of regurgitation from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.190|-1.087|0.168
91710494|NCT00502853|183313645|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Student's t-test|||Change from Baseline at Week 12||||0.0832
91710495|NCT00502853|183313645|SUPERIORITY_OR_OTHER|||||||0.1685|||||||Student's t-test|||Change from Baseline at Week 24||||0.1685
91710496|NCT00502853|183313645|SUPERIORITY_OR_OTHER||Slope|-55.4458|STANDARD_ERROR_OF_MEAN|33.5821||0.1331|||||||Random coefficient model|||Trend over time||||0.1331
91710497|NCT00502853|183313646|SUPERIORITY_OR_OTHER|||||||0.2938|||||||Student's t-test|||Change from Baseline at Week 4||||0.2938
91710498|NCT00502853|183313646|SUPERIORITY_OR_OTHER|||||||0.2216|||||||Student's t-test|||Change from Baseline at Week 12||||0.2216
91710499|NCT00502853|183313646|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Student's t-test|||Change from Baseline at Week 24||||0.5670
91710500|NCT00502853|183313647|SUPERIORITY_OR_OTHER|||||||0.0934|||||||Student's t-test|||Change from Baseline at Week 4||||0.0934
91710501|NCT00502853|183313647|SUPERIORITY_OR_OTHER|||||||0.4047|||||||Student's t-test|||Change from Baseline at Week 12||||0.4047
91710502|NCT00502853|183313647|SUPERIORITY_OR_OTHER|||||||0.2101|||||||Student's t-test|||Change from Baseline at Week 24||||0.2101
91710503|NCT00502853|183313647|SUPERIORITY_OR_OTHER||Slope|0.3997|STANDARD_ERROR_OF_MEAN|0.2506||0.1451|||||||Random coefficient model|||Trend over time||||0.1451
91710504|NCT00502853|183313648|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Student's t-test|||Change from Baseline at Week 4||||0.4963
91710505|NCT00502853|183313648|SUPERIORITY_OR_OTHER|||||||0.2198|||||||Student's t-test|||Change from Baseline at Week 12||||0.2198
91710506|NCT00502853|183313648|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Student's t-test|||Change from Baseline at Week 24||||0.6773
91710507|NCT00502853|183313648|SUPERIORITY_OR_OTHER||Slope|0.3688|STANDARD_ERROR_OF_MEAN|0.5987||0.5531|||||||Random coefficient model|||Trend over time||||0.5531
91710508|NCT00502853|183313649|SUPERIORITY_OR_OTHER|||||||0.5002|||||||Student's t-test|||Change from Baseline at Week 24||||0.5002
91710509|NCT00502853|183313650|SUPERIORITY_OR_OTHER|||||||1|||||||Student's t-test|||Change from Baseline at Week 24||||1.0000
91710510|NCT00502853|183313651|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Student's t-test|||Change from Baseline at Week 24||||0.7002
91710511|NCT00502853|183313652|SUPERIORITY_OR_OTHER|||||||0.3132|||||||Student's t-test|||Change from Baseline at Week 24||||0.3132
91710512|NCT00502853|183313653|SUPERIORITY_OR_OTHER|||||||0.8597|||||||Student's t-test|||Change from Baseline at Week 24||||0.8597
91710513|NCT00502853|183313654|SUPERIORITY_OR_OTHER|||||||0.3617|||||||Student's t-test|||Change from Baseline at Week 24||||0.3617
91710514|NCT03162328|183313682|SUPERIORITY|||||||0.363|||||||Wilcoxon Signed Ranks Test|||||||0.363
91710515|NCT03162328|183313683|SUPERIORITY|||||||0.291|||||||Wilcoxon Signed Ranks Test|||||||0.291
91654801|NCT02207231|183201961|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10%|Difference in percentage|18.0|||<|0.001|TWO_SIDED|95.0|12.4|23.8|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||23.8|12.4|< 0.001
91654802|NCT02207231|183201961|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91654803|NCT02207231|183201962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91710516|NCT01990768|183313695|SUPERIORITY||Odds Ratio (OR)|0.87||||0.1809|ONE_SIDED|||||Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.|Regression, Logistic|Analysis was adjusted for regional site. Missing outcomes were multiply imputed.|Odds ratio for unfavorable GOS-E (\<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)|This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.||||.1809
91710517|NCT03479944|183313714|SUPERIORITY||Least Squares Mean Difference|-1.505|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.289|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-1.289|-1.720|<0.0001
91789537|NCT00992589|183458783|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.03||||0.44|TWO_SIDED|95.0|-0.047|0.108|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Double-blind (DB) Baseline as covariate to test the hypothesis of no difference in change in Weight-for-Age Z-Score from DB Baseline to DB Endpoint between Rabeprazole Sodium Total and Placebo.||0.108|-0.047|0.440
91789538|NCT00992589|183458785|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.006||||0.984|TWO_SIDED|95.0|-0.619|0.632|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Regurgitation Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.632|-0.619|0.984
91789539|NCT00992589|183458786|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.182||||0.479|TWO_SIDED|95.0|-0.69|0.325|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Discomfort Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.325|-0.690|0.479
91524089|NCT01216163|182923473|SUPERIORITY_OR_OTHER||LS mean difference|2.33||||0.006|TWO_SIDED|95.0|0.67|4.0||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.00|0.67|0.006
91612717|NCT03151148|183119865|SUPERIORITY||Geometric mean ratio (GMR)|2.858||||0.13|TWO_SIDED|95.0|0.7328|11.1434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||11.1434|0.7328|0.130
91612718|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|3.16||||0.233|TWO_SIDED|95.0|0.476|20.952|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.952|0.476|0.233
91654804|NCT02207231|183201963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
91654805|NCT02207231|183201964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91654806|NCT01545076|183202013|SUPERIORITY||Difference in Percent|-24.6|||=|0.007|TWO_SIDED|95.0|-40.7|-6.21|||Fisher Exact|||||-6.21|-40.7|=0.007
91654807|NCT01545076|183202013|SUPERIORITY||Difference in Percent|-30.4|||<|0.001|TWO_SIDED|95.0|-46.0|-12.2|||Fisher Exact|||||-12.2|-46.0|<0.001
91654808|NCT01545076|183202014|OTHER||Median Difference (Net)|0.0|||=|0.005|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|=0.005
91654809|NCT01545076|183202014|OTHER||Median Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|<0.001
91654810|NCT01545076|183202015|OTHER||Median Difference (Net)|7.6|||=|0.004|TWO_SIDED|95.0|2.0|14.0|||Wilcoxon rank sum|||||14|2|=0.004
91710518|NCT03479944|183313715|SUPERIORITY||Least Squares Mean Difference|1.2||||0.2602|TWO_SIDED|95.0|-0.9|3.3|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||3.3|-0.9|0.2602
91710519|NCT03479944|183313716|SUPERIORITY||Least Squares Mean Difference|-11.52|||||TWO_SIDED|95.0|-15.87|-7.18|||||Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-7.18|-15.87|
91789540|NCT00992589|183458787|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.192||||0.498|TWO_SIDED|95.0|-0.751|0.366|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Eating Behavior Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.366|-0.751|0.498
91789541|NCT00992589|183458788|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.042||||0.96|TWO_SIDED|95.0|-1.615|1.7|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in I-GERQ-R Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.700|-1.615|0.960
91789542|NCT00992589|183458789|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.024||||0.968|TWO_SIDED|95.0|-1.167|1.214|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in Weekly Average I-GERQ-DD Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.214|-1.167|0.968
91789543|NCT04575597|183458829|OTHER|Difference in rates % and associated confidence intervals (CIs) were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-4.1|||||TWO_SIDED|95.0|-12.2|2.5||||||||2.5|-12.2|
91789544|NCT04575597|183458829|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-1.5|||||TWO_SIDED|95.0|-9.9|6.2||||||||6.2|-9.9|
91789545|NCT04575597|183458829|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Differences in Rates %|-1.3|||||TWO_SIDED|95.0|-9.6|6.4||||||||6.4|-9.6|
91789546|NCT04575597|183458829|SUPERIORITY|Difference in rates %, associated CIs, and p-value were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-6.8||||0.0012|TWO_SIDED|95.0|-11.3|-2.4|||Miettinen & Nurminen|||||-2.4|-11.3|0.0012
91524090|NCT01216163|182923473|SUPERIORITY_OR_OTHER||LS mean difference|7.24|||<|0.001|TWO_SIDED|95.0|5.21|9.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.28|5.21|<0.001
91612719|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.08||||0.008|TWO_SIDED|95.0|0.012|0.514|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.514|0.012|0.008
91613847|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
91613848|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
91613849|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.047|||<|0.0001|TWO_SIDED|95.0|1.029|1.065|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.065|1.029|<0.0001
91613850|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.0074|TWO_SIDED|95.0|0.827|0.971|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.971|0.827|0.0074
91613851|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.971||||0.0088|TWO_SIDED|95.0|0.95|0.993|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.950|0.0088
91654811|NCT01545076|183202015|OTHER||Median Difference (Net)|5.7|||=|0.014|TWO_SIDED|95.0|0.7|11.7|||Wilcoxon rank sum|||||11.7|0.7|=0.014
91654812|NCT01545076|183202016|OTHER||Median Difference (Final Values)|2.0|||=|0.003|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.003
91613852|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.719|||<|0.0001|TWO_SIDED|95.0|0.643|0.803|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.803|0.643|<0.0001
91789547|NCT04575597|183458832|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.48|1.13||||||||1.13|0.48|
91789548|NCT04575597|183458832|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.46|1.08||||||||1.08|0.46|
91789549|NCT04575597|183458832|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.47|1.11||||||||1.11|0.47|
91789550|NCT04575597|183458832|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||||1.18|0.92|
91524091|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|21.42|||<|0.001|TWO_SIDED|95.0|12.99|29.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||29.84|12.99|<0.001
91789551|NCT04575597|183458833|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.8|2.76||||||||2.76|0.80|
91789552|NCT04575597|183458833|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.69|2.09||||||||2.09|0.69|
91789553|NCT04575597|183458833|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.54|1.62||||||||1.62|0.54|
91612720|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.298|0.007|0.001
91612721|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.651|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.651|0.013|0.017
91612722|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.292|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.292|0.007|0.001
91789554|NCT04575597|183458833|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.95|1.33||||||||1.33|0.95|
91612723|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.358|TWO_SIDED|95.0|0.366|15.967|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.967|0.366|0.358
91612724|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.1||||0.019|TWO_SIDED|95.0|0.016|0.683|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.683|0.016|0.019
91612725|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.11||||0.023|TWO_SIDED|95.0|0.017|0.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.739|0.017|0.023
91654813|NCT01545076|183202016|OTHER||Median Difference (Final Values)|2.0|||=|0.002|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.002
91654814|NCT01545076|183202017|OTHER||Median Difference (Net)|3.0|||=|0.03|TWO_SIDED|95.0|0.0|9.0|||Wilcoxon rank sum|||||9|0|=0.03
91654815|NCT01545076|183202017|OTHER||Median Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|2.0|9.0|||Wilcoxon rank sum|||||9|2|<0.001
91654816|NCT00797108|183202039|SUPERIORITY_OR_OTHER||Clinical Cure Difference|27.5|||||TWO_SIDED|80.0|-4.0|55.3||||||Two-sided 80% confidence interval (CI) for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||55.3|-4.0|
91654817|NCT00797108|183202039|SUPERIORITY_OR_OTHER||Clinical Cure Difference|25.0|||||TWO_SIDED|80.0|-13.1|57.9||||||Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||57.9|-13.1|
91789555|NCT04575597|183458834|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.62|1.46||||||||1.46|0.62|
91789556|NCT04575597|183458834|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
91654818|NCT03238677|183202051|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.132|TWO_SIDED|95.0|-23.2|3.1|||Mixed Models Analysis|||Main effect of biofeedback at 10 weeks||3.1|-23.2|.132
91654819|NCT03238677|183202051|SUPERIORITY||Mean Difference (Final Values)|-13.7||||0.028|TWO_SIDED|95.0|-25.9|-1.5|||Mixed Models Analysis|||Main effect of Practice Distribution at 10 weeks||-1.5|-25.9|.028
91789557|NCT04575597|183458834|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.45|1.07||||||||1.07|0.45|
91789558|NCT04575597|183458834|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.93|1.23||||||||1.23|0.93|
91789559|NCT04575597|183458835|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.83||||||||1.83|0.62|
91789560|NCT04575597|183458835|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.4|1.26||||||||1.26|0.40|
91612726|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.647|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.647|0.013|0.017
91612727|NCT03151148|183119866|SUPERIORITY||Geometric mean ratio (GMR)|0.37||||0.299|TWO_SIDED|95.0|0.056|2.436|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.436|0.056|0.299
91612728|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|1.49||||0.538|TWO_SIDED|95.0|0.415|5.38|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|5.380|0.415|0.538
91612729|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.88||||0.849|TWO_SIDED|95.0|0.245|3.18|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.180|0.245|0.849
91612730|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.4||||0.155|TWO_SIDED|95.0|0.11|1.424|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.424|0.110|0.155
91612731|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.45||||0.242|TWO_SIDED|95.0|0.117|1.722|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.722|0.117|0.242
91612732|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.47||||0.258|TWO_SIDED|95.0|0.129|1.735|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.735|0.129|0.258
91613853|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.683|||<|0.0001|TWO_SIDED|95.0|1.346|2.106|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.106|1.346|<0.0001
91789561|NCT04575597|183458835|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.2|0.85||||||||0.85|0.20|
91789562|NCT04575597|183458835|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.86|1.18||||||||1.18|0.86|
91654820|NCT03238677|183202051|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.187|TWO_SIDED|95.0|-24.9|5.0|||Mixed Models Analysis|||Main effect comparing telepractice vs face-to-face treatment||5.0|-24.9|.187
91789563|NCT04575597|183458836|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.32|1.34||||||||1.34|0.32|
91789564|NCT04575597|183458836|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.76|2.71||||||||2.71|0.76|
91789565|NCT04575597|183458836|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.39|1.42||||||||1.42|0.39|
91612733|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|1.26||||0.726|TWO_SIDED|95.0|0.349|4.52|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.520|0.349|0.726
91612734|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.32||||0.08|TWO_SIDED|95.0|0.088|1.145|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.145|0.088|0.080
91613854|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.4479|TWO_SIDED|95.0|0.848|1.453|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.453|0.848|0.4479
91613855|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0123|TWO_SIDED|95.0|0.451|0.908|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.451|0.0123
91613856|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.0147|TWO_SIDED|95.0|0.553|0.937|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.937|0.553|0.0147
91613857|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.718||||0.0071|TWO_SIDED|95.0|0.564|0.914|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.914|0.564|0.0071
91613858|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.058|||<|0.0001|TWO_SIDED|95.0|1.052|1.064|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.064|1.052|<0.0001
91613859|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.0019|TWO_SIDED|95.0|1.005|1.023|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.023|1.005|0.0019
91613860|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.701||||0.0083|TWO_SIDED|95.0|0.539|0.913|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.539|0.0083
91613861|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.174|||<|0.0001|TWO_SIDED|95.0|0.09|0.338|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.338|0.090|<0.0001
91613862|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.057||||0.0008|TWO_SIDED|95.0|1.023|1.091|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.091|1.023|0.0008
91710520|NCT01554163|183313743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).|Difference in LS Mean Change|-1.63||||0.39|TWO_SIDED|95.0|-5.37|2.1|||ANCOVA|||||2.10|-5.37|0.390
91710521|NCT01554163|183313744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.32||||0.464|TWO_SIDED|95.0|-4.88|2.23|||ANCOVA|||||2.23|-4.88|0.464
91710522|NCT01554163|183313745|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.09||||0.624|TWO_SIDED|95.0|-5.48|3.3|||ANCOVA|||||3.30|-5.48|0.624
91789566|NCT04575597|183458836|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
91789567|NCT04575597|183458837|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.66|1.61||||||||1.61|0.66|
91789568|NCT04575597|183458837|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.83|2.09||||||||2.09|0.83|
91789569|NCT04575597|183458837|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.23||||||||1.23|0.47|
91789570|NCT04575597|183458837|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||||1.16|0.88|
91789571|NCT04575597|183458838|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.41||||||||1.41|0.62|
91789572|NCT04575597|183458838|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.7|1.69||||||||1.69|0.70|
91612735|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.81||||0.748|TWO_SIDED|95.0|0.225|2.917|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.917|0.225|0.748
91612736|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|1.23||||0.76|TWO_SIDED|95.0|0.327|4.617|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.617|0.327|0.760
91612737|NCT03151148|183119867|SUPERIORITY||Geometric mean ratio (GMR)|0.79||||0.713|TWO_SIDED|95.0|0.219|2.832|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.832|0.219|0.713
91710523|NCT01554163|183313746|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.08||||0.369|TWO_SIDED|95.0|-0.26|0.1|||ANCOVA|||||0.10|-0.26|0.369
91789573|NCT04575597|183458838|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
91710524|NCT01554163|183313747|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.09||||0.294|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||||0.08|-0.25|0.294
91710525|NCT01554163|183313748|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.86||||0.679|TWO_SIDED|95.0|-4.96|3.24|||ANCOVA|||||3.24|-4.96|0.679
91710526|NCT01554163|183313749|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.1||||0.314|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.10|-0.30|0.314
91710527|NCT02634983|183313754|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.11||0.0254|TWO_SIDED|90.0|1.4|8.6|||t-test, 2 sided|||Global Ventilated Lung Volume||8.60|1.40|0.0254
91789574|NCT04575597|183458838|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.01|1.31||||||||1.31|1.01|
91789575|NCT04575597|183458839|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.54|1.69||||||||1.69|0.54|
91789576|NCT04575597|183458839|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.61|2.0||||||||2.00|0.61|
91789577|NCT04575597|183458839|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.5|1.38||||||||1.38|0.50|
91789578|NCT04575597|183458839|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.21||||||||1.21|0.90|
91789579|NCT04575597|183458840|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.77|2.76||||||||2.76|0.77|
91789580|NCT04575597|183458840|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.76|||||TWO_SIDED|95.0|0.92|3.38||||||||3.38|0.92|
91612738|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|12.08|||<|0.001|TWO_SIDED|95.0|3.524|41.435|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||41.435|3.524|<0.001
91789581|NCT04575597|183458840|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|0.81|2.86||||||||2.86|0.81|
91789582|NCT04575597|183458840|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.89|1.24||||||||1.24|0.89|
91524092|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|1.58||||0.799|TWO_SIDED|95.0|-10.54|13.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.70|-10.54|0.799
91789583|NCT04575597|183458841|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.81|2.2||||||||2.20|0.81|
91789584|NCT04575597|183458841|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.85|2.31||||||||2.31|0.85|
91789585|NCT04575597|183458841|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.57|1.65||||||||1.65|0.57|
91789586|NCT04575597|183458841|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
91789587|NCT04575597|183458842|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.36|1.91||||||||1.91|0.36|
91789588|NCT04575597|183458842|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.64|2.97||||||||2.97|0.64|
91789589|NCT04575597|183458842|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.37|2.02||||||||2.02|0.37|
91612739|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|2.58||||0.131|TWO_SIDED|95.0|0.753|8.853|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.853|0.753|0.131
91612740|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|2.2||||0.21|TWO_SIDED|95.0|0.64|7.527|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.527|0.640|0.210
91612741|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.031|TWO_SIDED|95.0|1.138|13.29|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.290|1.138|0.031
91612742|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|1.64||||0.429|TWO_SIDED|95.0|0.479|5.63|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.630|0.479|0.429
91612743|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|9.26||||0.01|TWO_SIDED|95.0|1.712|50.043|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||50.043|1.712|0.010
91612744|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|3.45||||0.15|TWO_SIDED|95.0|0.637|18.627|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||18.627|0.637|0.150
91612745|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|5.47||||0.048|TWO_SIDED|95.0|1.012|29.578|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||29.578|1.012|0.048
91654821|NCT03238677|183202051|SUPERIORITY||Mean Difference (Final Values)|20.22||||0.125|TWO_SIDED|95.0|-5.8|46.3|||Mixed Models Analysis|||Interaction of biofeedback and practice distribution at 10 weeks|η2 =.054|46.3|-5.8|.125
91789590|NCT04575597|183458842|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.74|1.14||||||||1.14|0.74|
91789591|NCT04575597|183458843|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.44|1.06||||||||1.06|0.44|
91789592|NCT04575597|183458844|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.06|0.67||||||||0.67|0.06|
91789593|NCT04575597|183458844|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.13|0.83||||||||0.83|0.13|
91789594|NCT04575597|183458844|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.79||||||||0.79|0.09|
91789595|NCT04575597|183458844|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||||||||1.36|0.87|
91613863|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
91710528|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|2.15||0.035|TWO_SIDED|90.0|1.11|8.44|||t-test, 2 sided|||Lung, Left Ventilation||8.44|1.11|0.0350
91710529|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.96|STANDARD_ERROR_OF_MEAN|2.86||0.0946|TWO_SIDED|90.0|0.08|9.84|||t-test, 2 sided|||Lung, Left Lower Lobe Ventilation||9.84|0.08|0.0946
91710530|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.41||0.0486|TWO_SIDED|90.0|0.87|9.07|||t-test, 2 sided|||Lung, Left Upper Lobe Ventilation||9.07|0.87|0.0486
91710531|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|2.33||0.0286|TWO_SIDED|90.0|1.42|9.35|||t-test, 2 sided|||Lung, Right Ventilation||9.35|1.42|0.0286
91612746|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.13|TWO_SIDED|95.0|0.665|23.821|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||23.821|0.665|0.130
91710532|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.29||0.165|TWO_SIDED|90.0|-0.63|7.17|||t-test, 2 sided|||Lung, Right Lower Lobe Ventilation||7.17|-0.63|0.1650
91789596|NCT04575597|183458845|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.23||||||||2.23|0.74|
91789597|NCT04575597|183458845|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.45|1.8||||||||1.80|0.45|
91789598|NCT04575597|183458845|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.55|1.89||||||||1.89|0.55|
91612747|NCT03151148|183119868|SUPERIORITY||Geometric mean ratio (GMR)|13.74||||0.002|TWO_SIDED|95.0|2.542|74.304|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||74.304|2.542|0.002
91710533|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.71||0.1421|TWO_SIDED|90.0|-0.71|11.94|||t-test, 2 sided|||Lung, Right Middle Lobe Ventilation||11.94|-0.71|0.1421
91789599|NCT04575597|183458845|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
91710534|NCT02634983|183313755|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|7.73|STANDARD_ERROR_OF_MEAN|2.78||0.0099|TWO_SIDED|90.0|2.98|12.47|||t-test, 2 sided|||Lung, Right Upper Lobe Ventilation||12.47|2.98|0.0099
91710535|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.92||0.323|TWO_SIDED|90.0|-0.64|2.5|||t-test, 2 sided|||Lung Perfusion||2.50|-0.64|0.3230
91710536|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.95||0.1717|TWO_SIDED|90.0|-0.29|2.97|||t-test, 2 sided|||Lung, Left Perfusion||2.97|-0.29|0.1717
91710537|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|1.02||0.5031|TWO_SIDED|90.0|-1.05|2.43|||t-test, 2 sided|||Lung, Left Lower Lobe Perfusion||2.43|-1.05|0.5031
91710538|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|1.03||0.076|TWO_SIDED|90.0|0.15|3.65|||t-test, 2 sided|||Lung, Left Upper Lobe Perfusion||3.65|0.15|0.0760
91654822|NCT03194464|183202065|OTHER|||||||0.15||||||The a priori threshold for statistical significance was established at p \<.05 (non-adjusted).|ANOVA|||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by less affected hand exercise to task-failure and to determine the time course and recovery of this effect.||||0.15
91654823|NCT03194464|183202066|SUPERIORITY|||||||0.83||||||Statistical Significance established as p \<.05|ANOVA|Repeated-Measures ANOVA||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by repeated sessions of less affected hand exercise to task-failure. Pre-exercise SICI was compared between Session1 and Session8.||||.83
91789600|NCT04575597|183458846|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.83|2.33||||||||2.33|0.83|
91789601|NCT04575597|183458846|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.5|1.48||||||||1.48|0.50|
91654824|NCT03194464|183202067|OTHER|||||||0.204|||||||ANOVA|||RM-ANOVA||||0.204
91654825|NCT03194464|183202068|SUPERIORITY|||||||0.004||||||statistical significance was established a priori at p \<.05|ANOVA|repeated measures ANOVA comparing Session8 vs. Session1 performance||We performed repeated measures analysis of variance (RM-ANOVA) to determine if motor dexterity, as measured by the BBT, was improved by repeated sessions of non-paretic hand exercise to task-failure. BBT performance was compared between Session1 and Session8.||||.004
91654826|NCT02129348|183202079|SUPERIORITY||Treatment Effect Difference|0.7||||0.53|TWO_SIDED|95.0|-1.4|2.7||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Lithium will significantly reduce agitation/aggression compared to placebo. In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.7|-1.4|0.53
91654827|NCT02129348|183202080|SUPERIORITY||Treatment Effect Difference|2.11||||0.26|TWO_SIDED|95.0|0.73|6.13||The threshold for statistical significance was p = 0.05.|Chi-squared||Odds ratio and its 95% confidence interval were computed.|Change in both NPI core score (≥30% versus \<30%) and CGI behavior change (1 or 2 versus ≥3) were required for response; these two measures were then analyzed separately. A x² test was used to identify whether there was a change in NPI core scores and CGI scores from baseline to week 12.||6.13|0.73|0.26
91654828|NCT02129348|183202081|SUPERIORITY||Treatment Effect Difference|1.79||||0.25|TWO_SIDED|95.0|0.64|5.04||The threshold of statistical significance was p = 0.05.|Chi-squared|||CGI behavior change scores were categorized into responders versus non-responders (1 or 2 versus ≥3) using the last variable observation for drop-outs. A x² test was used to identify the percentage of participants in each group, lithium versus placebo, that improved from baseline to week 12.||5.04|0.64|0.25
91654829|NCT02129348|183202082|SUPERIORITY||Treatment Effect Difference|2.0||||0.21|TWO_SIDED|95.0|-1.1|5.1||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||5.1|-1.1|0.21
91612748|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|3.68||||0.001|TWO_SIDED|95.0|1.689|8.028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.028|1.689|0.001
91654830|NCT02129348|183202083|SUPERIORITY||Treatment Effect Difference|-0.1||||0.91|TWO_SIDED|95.0|-2.6|2.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.4|-2.6|0.91
91654831|NCT02129348|183202084|SUPERIORITY||Treatment Effect Difference|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= -0.02 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.4|-1.5|0.94
91789602|NCT04575597|183458846|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.56|1.72||||||||1.72|0.56|
91789603|NCT04575597|183458846|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|1.01|1.43||||||||1.43|1.01|
91789604|NCT04575597|183458847|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.19||||||||2.19|0.29|
91789605|NCT04575597|183458847|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.34|2.44||||||||2.44|0.34|
91612749|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.027|TWO_SIDED|95.0|1.109|5.267|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.267|1.109|0.027
91612750|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.153|TWO_SIDED|95.0|0.81|3.847|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.847|0.810|0.153
91613864|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
91789606|NCT04575597|183458847|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.74|4.23||||||||4.23|0.74|
91789607|NCT04575597|183458847|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.04||||||||1.04|0.67|
91612751|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.16|TWO_SIDED|95.0|0.799|3.884|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.884|0.799|0.160
91789608|NCT04575597|183458848|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|2.52|||||TWO_SIDED|95.0|0.98|6.53||||||||6.53|0.98|
91613865|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
91789609|NCT04575597|183458848|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.23|2.52||||||||2.52|0.23|
91789610|NCT04575597|183458848|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.11|1.84||||||||1.84|0.11|
91789611|NCT04575597|183458848|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.16||||||||1.16|0.66|
91789612|NCT04575597|183458849|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.32||||||||3.32|0.46|
91789613|NCT04575597|183458849|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.54|3.74||||||||3.74|0.54|
91789614|NCT04575597|183458849|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.34|2.76||||||||2.76|0.34|
91789615|NCT04575597|183458849|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.66|1.1||||||||1.10|0.66|
91789616|NCT04575597|183458850|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.41|2.52||||||||2.52|0.41|
91789617|NCT04575597|183458850|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.9||||||||1.90|0.26|
91789618|NCT04575597|183458850|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.51|3.0||||||||3.00|0.51|
91789619|NCT04575597|183458850|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
91789620|NCT04575597|183458851|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.36|1.75||||||||1.75|0.36|
91789621|NCT04575597|183458851|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.33|1.64||||||||1.64|0.33|
91789622|NCT04575597|183458851|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.31|1.62||||||||1.62|0.31|
91789623|NCT04575597|183458851|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.76|1.16||||||||1.16|0.76|
91789624|NCT04575597|183458852|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
91789625|NCT04575597|183458852|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.38|1.78||||||||1.78|0.38|
91789626|NCT04575597|183458852|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
91789627|NCT04575597|183458852|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
91789628|NCT04575597|183458853|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.26|1.34||||||||1.34|0.26|
91612752|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|1.32||||0.489|TWO_SIDED|95.0|0.603|2.868|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.868|0.603|0.489
91612753|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|3.1||||0.044|TWO_SIDED|95.0|1.032|9.295|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.295|1.032|0.044
91612754|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|0.87||||0.805|TWO_SIDED|95.0|0.29|2.614|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.614|0.290|0.805
91613866|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
91654832|NCT02129348|183202085|SUPERIORITY||Treatment Effect Difference|0.2||||0.63|TWO_SIDED|95.0|-0.4|0.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||0.8|-0.4|0.63
91654833|NCT02129348|183202086|SUPERIORITY||Treatment Effect Difference|3.2||||0.24|TWO_SIDED|95.0|-2.1|8.4||The threshold of statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= 0.44 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||8.4|-2.1|0.24
91789629|NCT04575597|183458853|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.28|1.37||||||||1.37|0.28|
91789630|NCT04575597|183458853|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.38|1.74||||||||1.74|0.38|
91789631|NCT04575597|183458853|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.79|1.21||||||||1.21|0.79|
91789632|NCT04575597|183458854|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.47|3.02||||||||3.02|0.47|
91789633|NCT04575597|183458854|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.29|2.2||||||||2.20|0.29|
91789634|NCT04575597|183458854|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.45||||||||2.45|0.32|
91789635|NCT04575597|183458854|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||||1.11|0.62|
91789636|NCT04575597|183458855|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.3|2.27||||||||2.27|0.30|
91789637|NCT04575597|183458855|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.04|1.0||||||||1.00|0.04|
91789638|NCT04575597|183458855|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.91||||||||1.91|0.23|
91789639|NCT04575597|183458855|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||||1.23|0.62|
91789640|NCT04575597|183458856|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.28|1.2||||||||1.20|0.28|
91612755|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|3.62||||0.022|TWO_SIDED|95.0|1.205|10.859|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||10.859|1.205|0.022
91612756|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|4.83||||0.01|TWO_SIDED|95.0|1.458|15.978|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.978|1.458|0.010
91612757|NCT03151148|183119869|SUPERIORITY||Geometric mean ratio (GMR)|2.19||||0.169|TWO_SIDED|95.0|0.716|6.692|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.692|0.716|0.169
91612758|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.176||||0.035|TWO_SIDED|95.0|0.0351|0.8807|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.8807|0.0351|0.035
91612759|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.214||||0.06|TWO_SIDED|95.0|0.0427|1.0702|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0702|0.0427|0.060
91612760|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.182||||0.038|TWO_SIDED|95.0|0.0363|0.91|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.9100|0.0363|0.038
91612761|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.329||||0.179|TWO_SIDED|95.0|0.065|1.6691|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6691|0.0650|0.179
91710539|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.93||0.5465|TWO_SIDED|90.0|-1.02|2.16|||t-test, 2 sided|||Lung, Right Perfusion||2.16|-1.02|0.5465
91710540|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.08||0.9913|TWO_SIDED|90.0|-1.85|1.87|||t-test, 2 sided|||Lung, Right Lower Lobe Perfusion||1.87|-1.85|0.9913
91710541|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|1.7||0.3837|TWO_SIDED|90.0|-1.39|4.4|||t-test, 2 sided|||Lung, Right Middle Lobe Perfusion||4.40|-1.39|0.3837
91789641|NCT04575597|183458856|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.2|0.95||||||||0.95|0.20|
91789642|NCT04575597|183458856|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.43|1.59||||||||1.59|0.43|
91612762|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.136||||0.015|TWO_SIDED|95.0|0.0271|0.6805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.6805|0.0271|0.015
91613867|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
91789643|NCT04575597|183458856|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19||||||||1.19|0.73|
91789644|NCT04575597|183458857|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.35|2.11||||||||2.11|0.35|
91789645|NCT04575597|183458857|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.16|1.34||||||||1.34|0.16|
91613868|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
91613869|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.0042|TWO_SIDED|95.0|0.822|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.822|0.0042
91613870|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.824||||0.0363|TWO_SIDED|95.0|0.687|0.988|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.687|0.0363
91613871|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.842||||0.0033|TWO_SIDED|95.0|0.751|0.944|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.944|0.751|0.0033
91612763|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.302||||0.309|TWO_SIDED|95.0|0.0299|3.0493|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.0493|0.0299|0.309
91612764|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.372||||0.401|TWO_SIDED|95.0|0.0369|3.7569|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.7569|0.0369|0.401
91612765|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.591||||0.655|TWO_SIDED|95.0|0.0586|5.9658|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.9658|0.0586|0.655
91612766|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|0.43||||0.488|TWO_SIDED|95.0|0.0395|4.6836|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.6836|0.0395|0.488
91612767|NCT03151148|183119870|SUPERIORITY||Geometric mean ratio (GMR)|1.485||||0.737|TWO_SIDED|95.0|0.1471|14.9869|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||14.9869|0.1471|0.737
91654834|NCT02129348|183202087|SUPERIORITY||Treatment Effect Difference|0.0||||0.96|TWO_SIDED|95.0|-1.7|1.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.01|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.8|-1.7|0.96
91654835|NCT02129348|183202088|SUPERIORITY||Treatment Effect Difference|2.2||||0.35|TWO_SIDED|95.0|-2.3|6.6||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.35|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||6.6|-2.3|0.35
91654836|NCT01463683|183202107|NON_INFERIORITY_OR_EQUIVALENCE|Incidence of seroprotection with V232-2XP SC is non-inferior to V232-1XP SC if the lower bound of the 95% confidence interval of the difference is greater than -10%|Difference in percentage of participants|7.6|||||TWO_SIDED|95.0|1.9|13.6|||Miettinen & Nurminen|||||13.6|1.9|
91654837|NCT01463683|183202108|SUPERIORITY_OR_OTHER||Difference in percentage of participants|4.9||||0.162|TWO_SIDED|95.0|-2.0|11.9|||Miettinen & Nurminen|||||11.9|-2.0|0.162
91789646|NCT04575597|183458857|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||||2.79|0.50|
91654838|NCT01463683|183202108|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.028|TWO_SIDED|95.0|1.1|21.6|||Miettinen & Nurminen|||||21.6|1.1|0.028
91654839|NCT01463683|183202108|SUPERIORITY_OR_OTHER||Difference in percentage of participants|6.0||||0.246|TWO_SIDED|95.0|-4.0|16.8|||Miettinen & Nurminen|||||16.8|-4.0|0.246
91789647|NCT04575597|183458857|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.74|1.32||||||||1.32|0.74|
91789648|NCT04575597|183458858|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.06|15.54||||||||15.54|0.06|
91789649|NCT04575597|183458858|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0||NA = Upper limit not reached as no events were recorded||||||||0.00|
91710542|NCT02634983|183313756|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.94||0.3624|TWO_SIDED|90.0|-0.73|2.48|||t-test, 2 sided|||Lung, Right Upper Lobe Perfusion||2.48|-0.73|0.3624
91789650|NCT04575597|183458858|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.06|15.99||||||||15.99|0.06|
91612768|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.248||||0.011|TWO_SIDED|95.0|0.0844|0.7281|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.7281|0.0844|0.011
91612769|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.656||||0.44|TWO_SIDED|95.0|0.2245|1.9178|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.9178|0.2245|0.440
91612770|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.479||||0.178|TWO_SIDED|95.0|0.164|1.4007|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4007|0.1640|0.178
91654840|NCT01463683|183202109|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.7||||0.659|TWO_SIDED|95.0|-3.8|2.4|||Miettinen & Nurminen|||||2.4|-3.8|0.659
91654841|NCT01463683|183202109|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-1.6||||0.459|TWO_SIDED|95.0|-7.7|2.2|||Miettinen & Nurminen|||||2.2|-7.7|0.459
91654842|NCT01463683|183202109|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.686|TWO_SIDED|95.0|-7.1|3.0|||Miettinen & Nurminen|||||3.0|-7.1|0.686
91654843|NCT00365352|183202130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0015||95.0|-5.6|-1.3|||ANCOVA||Mean difference was adjusted for Baseline value, treatment pooled sites, and treatment by pool site interaction.|||-1.3|-5.6|0.0015
91654844|NCT00365352|183202131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.287||||0.0001||95.0|2.338|7.861|||Regression, Logistic|A logistic regression model was used with treatment and pooled center as explanatory factors.||||7.861|2.338|0.0001
91789651|NCT04575597|183458858|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.46|1.25||||||||1.25|0.46|
91789652|NCT04575597|183458859|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.58|3.83||||||||3.83|0.58|
91654845|NCT02581345|183202171|EQUIVALENCE|Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|90.0|-0.043|0.072||||||||0.072|-0.043|
91654846|NCT02581345|183202171|EQUIVALENCE|Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|95.0|-0.054|0.082||||||||0.082|-0.054|
91789653|NCT04575597|183458859|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.42|3.05||||||||3.05|0.42|
91654847|NCT02581345|183202172|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.|Difference in proportion (M923 - EU RPP)|0.031|||||TWO_SIDED|95.0|-0.048|0.11||||||||0.110|-0.048|
91789654|NCT04575597|183458859|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.57|3.93||||||||3.93|0.57|
91710543|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|90.0|0.11|0.18|||t-test, 2 sided|||FEV1 Day 1 (0.25 hrs post-dose)||0.18|0.11|<0.0001
91789655|NCT04575597|183458859|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||||1.10|0.61|
91612771|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.478||||0.18|TWO_SIDED|95.0|0.1624|1.4091|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4091|0.1624|0.180
91612772|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.357||||0.06|TWO_SIDED|95.0|0.1222|1.0441|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0441|0.1222|0.060
91612773|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.498||||0.373|TWO_SIDED|95.0|0.1068|2.3188|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.3188|0.1068|0.373
91612774|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.281||||0.106|TWO_SIDED|95.0|0.0604|1.3106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.3106|0.0604|0.106
91612775|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|1.168||||0.843|TWO_SIDED|95.0|0.2507|5.4434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.4434|0.2507|0.843
91612776|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|1.559||||0.587|TWO_SIDED|95.0|0.3122|7.7818|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.7818|0.3122|0.587
91612777|NCT03151148|183119871|SUPERIORITY||Geometric mean ratio (GMR)|0.707||||0.661|TWO_SIDED|95.0|0.1495|3.3426|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.3426|0.1495|0.661
91612778|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|1197.16|||<|0.001|TWO_SIDED|95.0|525.563|2726.953|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2726.953|525.563|<0.001
91789656|NCT04575597|183458860|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.11|1.21||||||||1.21|0.11|
91789657|NCT04575597|183458860|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.2|1.36||||||||1.36|0.20|
91789658|NCT04575597|183458860|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.29|1.89||||||||1.89|0.29|
91612779|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|779.24|||<|0.001|TWO_SIDED|95.0|342.093|1774.996|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1774.996|342.093|<0.001
91612780|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|673.56|||<|0.001|TWO_SIDED|95.0|295.697|1534.265|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1534.265|295.697|<0.001
91612781|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|60.12|||<|0.001|TWO_SIDED|95.0|24.92|145.027|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|145.027|24.920|<0.001
91612782|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|3.79||||0.002|TWO_SIDED|95.0|1.636|8.767|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.767|1.636|0.002
91612783|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|757.38|||<|0.001|TWO_SIDED|95.0|331.143|1732.242|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1732.242|331.143|<0.001
91612784|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|199.71|||<|0.001|TWO_SIDED|95.0|87.636|455.127|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||455.127|87.636|<0.001
91613872|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.477||||0.0006|TWO_SIDED|95.0|1.183|1.844|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.844|1.183|0.0006
91789659|NCT04575597|183458860|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.68|1.2||||||||1.20|0.68|
91789660|NCT04575597|183458861|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.09|1.33||||||||1.33|0.09|
91789661|NCT04575597|183458861|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.15||||||||2.15|0.30|
91789662|NCT04575597|183458861|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.18|1.48||||||||1.48|0.18|
91789663|NCT04575597|183458861|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.04||||||||1.04|0.62|
91789664|NCT04575597|183458862|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.04|||||TWO_SIDED|95.0|0.59|15.59||||||||15.59|0.59|
91789665|NCT04575597|183458862|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.29|6.16||||||||6.16|0.29|
91612785|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|508.45|||<|0.001|TWO_SIDED|95.0|223.113|1158.715|||Mixed Models Analysis|||"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|1158.715|223.113|<0.001
91789666|NCT04575597|183458862|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.09|1.44||||||||1.44|0.09|
91789667|NCT04575597|183458862|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.62|2.3||||||||2.30|0.62|
91789668|NCT04575597|183458863|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|1.14|11.88||||||||11.88|1.14|
91789669|NCT04575597|183458863|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.34|3.98||||||||3.98|0.34|
91789670|NCT04575597|183458863|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||||2.68|0.27|
91789671|NCT04575597|183458863|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|0.96|2.39||||||||2.39|0.96|
91789672|NCT04575597|183458864|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.82|3.45||||||||3.45|0.82|
91789673|NCT04575597|183458864|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.55|2.33||||||||2.33|0.55|
91789674|NCT04575597|183458864|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.27|1.29||||||||1.29|0.27|
91789675|NCT04575597|183458864|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|1.14|2.2||||||||2.20|1.14|
91789676|NCT04575597|183458865|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|0.73|2.73||||||||2.73|0.73|
91789677|NCT04575597|183458865|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.52|1.94||||||||1.94|0.52|
91789678|NCT04575597|183458865|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.34|1.32||||||||1.32|0.34|
91789679|NCT04575597|183458865|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|1.03|1.78||||||||1.78|1.03|
91789680|NCT04575597|183458866|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.35|1.66||||||||1.66|0.35|
91789681|NCT04575597|183458866|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.38|1.79||||||||1.79|0.38|
91789682|NCT04575597|183458866|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.37|1.81||||||||1.81|0.37|
91789683|NCT04575597|183458866|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
91789684|NCT04575597|183458867|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-3.0|||||TWO_SIDED|95.0|-5.9|-0.1||||||||-0.1|-5.9|
91789685|NCT01029405|183458897|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||<0.001
91612786|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|107.86|||<|0.001|TWO_SIDED|95.0|45.568|255.313|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||255.313|45.568|<0.001
91612787|NCT03151148|183119872|SUPERIORITY||Geometric mean ratio (GMR)|16.09|||<|0.001|TWO_SIDED|95.0|7.058|36.657|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.657|7.058|<0.001
91612788|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|142.89|||<|0.001|TWO_SIDED|95.0|58.484|349.119|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||349.119|58.484|<0.001
91612789|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|35.19|||<|0.001|TWO_SIDED|95.0|14.402|85.972|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||85.972|14.402|<0.001
91612790|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|41.64|||<|0.001|TWO_SIDED|95.0|17.043|101.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||101.739|17.043|<0.001
91612791|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|3.61||||0.008|TWO_SIDED|95.0|1.395|9.33|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.330|1.395|0.008
91612792|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|1.39||||0.474|TWO_SIDED|95.0|0.561|3.458|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.458|0.561|0.474
91612793|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|266.87|||<|0.001|TWO_SIDED|95.0|108.86|654.231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||654.231|108.860|<0.001
91612794|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|51.07|||<|0.001|TWO_SIDED|95.0|20.907|124.768|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||124.768|20.907|<0.001
91789686|NCT03312751|183458902|SUPERIORITY||Overall response rate|62.9||||0.0053|TWO_SIDED|95.0|44.9|78.5|||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||78.5|44.9|0.0053
91654848|NCT02581345|183202173|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|90.0|-0.061|0.016||||||||0.016|-0.061|
91654849|NCT02581345|183202173|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|95.0|-0.069|0.024||||||||0.024|-0.069|
91654850|NCT02581345|183202176|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|90.0|0.01|0.149||||||||0.149|0.010|
91524093|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|20.09||||0.001|TWO_SIDED|95.0|11.45|28.72||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||28.72|11.45|0.001
91524094|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|53.22|||<|0.001|TWO_SIDED|95.0|42.92|63.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.53|42.92|<0.001
91789687|NCT03312751|183458902|SUPERIORITY|||||||0.2839|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.2839
91789688|NCT03312751|183458902|SUPERIORITY|||||||0.0031|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.0031
91789689|NCT01856764|183458921|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.496||0.276|TWO_SIDED|95.0|-1.5542|0.4574||Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score|Mixed Models Analysis|||||0.4574|-1.5542|0.276
91789690|NCT01856764|183458922|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|3.454||0.095|TWO_SIDED|95.0|-12.9134|1.0835||MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score|Mixed Models Analysis|||||1.0835|-12.9134|0.095
91789691|NCT01856764|183458923|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.596||0.013|TWO_SIDED|95.0|-2.7656|-0.3492||MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score|Mixed Models Analysis|||||-0.3492|-2.7656|0.013
91789692|NCT00420641|183458924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.485|TWO_SIDED|90.0|-2.6|1.05|||Mixed Model Repeated Measures (MMRM)||The point estimate was calculated as least square (LS) mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS total score at Week 10.||1.05|-2.60|0.485
91789693|NCT00420641|183458924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99||||0|TWO_SIDED|90.0|-5.75|-2.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-2.22|-5.75|0.000
91789694|NCT00420641|183458925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.252|TWO_SIDED|90.0|-1.28|0.23|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in Bech score at Week 10.||0.23|-1.28|0.252
91789695|NCT00420641|183458925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0|TWO_SIDED|90.0|-2.49|-1.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-1.05|-2.49|0.000
91789696|NCT00420641|183458926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66||||0.279|TWO_SIDED|90.0|-4.19|0.87|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR total score at Week 10.||0.87|-4.19|0.279
91789697|NCT00420641|183458926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.001|TWO_SIDED|90.0|-7.55|-2.68|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR total score at Week 10.||-2.68|-7.55|0.001
91789698|NCT00420641|183458927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.287|TWO_SIDED|90.0|-5.23|1.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR total score at Week 10.||1.12|-5.23|0.287
91789699|NCT00420641|183458927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23||||0.001|TWO_SIDED|90.0|-9.21|-3.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR total score at Week 10.||-3.25|-9.21|0.001
91789700|NCT00420641|183458928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.352|TWO_SIDED|90.0|-1.47|0.41|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.||0.41|-1.47|0.352
91789701|NCT00420641|183458928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|90.0|-2.62|-0.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.||-0.81|-2.62|0.002
91789702|NCT00420641|183458929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.168|TWO_SIDED|90.0|-2.27|0.2|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.||0.20|-2.27|0.168
91524095|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|-2.98||||0.695|TWO_SIDED|95.0|-17.67|11.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.70|-17.67|0.695
91524096|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|57.06|||<|0.001|TWO_SIDED|95.0|46.53|67.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.60|46.53|<0.001
91612795|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|74.96|||<|0.001|TWO_SIDED|95.0|30.686|183.125|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||183.125|30.686|<0.001
91612796|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|26.06|||<|0.001|TWO_SIDED|95.0|10.262|66.169|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||66.169|10.262|<0.001
91613873|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128||||0.381|TWO_SIDED|95.0|0.862|1.477|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.477|0.862|0.3810
91789703|NCT00420641|183458929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.002|TWO_SIDED|90.0|-3.27|-0.97|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.||-0.97|-3.27|0.002
91789704|NCT00420641|183458930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.257|TWO_SIDED|90.0|-0.46|0.09|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS Item 2 score at Week 10.||0.09|-0.46|0.257
91789705|NCT00420641|183458930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.001|TWO_SIDED|90.0|-0.77|-0.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS Item 2 score at Week 10.||-0.25|-0.77|0.001
91789706|NCT00420641|183458931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.096|TWO_SIDED|90.0|-0.33|0.0|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.||-0.00|-0.33|0.096
91789707|NCT00420641|183458931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|90.0|-0.53|-0.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.||-0.22|-0.53|0.000
91789708|NCT00420641|183458932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.576|TWO_SIDED|90.0|-1.84|0.91|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 total score at Week 10.||0.91|-1.84|0.576
91789709|NCT00420641|183458932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0|TWO_SIDED|90.0|-4.28|-1.64|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 total score at Week 10.||-1.64|-4.28|0.000
91789710|NCT00420641|183458933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.209|TWO_SIDED|90.0|-0.38|0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.||0.05|-0.38|0.209
91789711|NCT00420641|183458933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002|TWO_SIDED|90.0|-0.6|-0.19|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.||-0.19|-0.60|0.002
91789712|NCT00420641|183458934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.175|TWO_SIDED|90.0|-1.23|0.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.||0.12|-1.23|0.175
91789713|NCT00420641|183458934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003|TWO_SIDED|90.0|-1.79|-0.5|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.||-0.50|-1.79|0.003
91789714|NCT00420641|183458934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.082|TWO_SIDED|90.0|-1.92|-0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.||-0.05|-1.92|0.082
91789715|NCT00420641|183458934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.001|TWO_SIDED|90.0|-2.64|-0.9|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.||-0.90|-2.64|0.001
91789716|NCT00420641|183458935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.208|TWO_SIDED|90.0|-0.45|0.06|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CGI-S score at Week 10.||0.06|-0.45|0.208
91524097|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|70.58|||<|0.001|TWO_SIDED|95.0|60.28|80.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.88|60.28|<0.001
91612797|NCT03151148|183119873|SUPERIORITY||Geometric mean ratio (GMR)|3.41||||0.007|TWO_SIDED|95.0|1.397|8.338|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.338|1.397|0.007
91612798|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|51.1|||<|0.001|TWO_SIDED|95.0|21.692|120.379|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||120.379|21.692|<0.001
91613874|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.812||||0.0279|TWO_SIDED|95.0|0.674|0.978|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.674|0.0279
91613875|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.894|||<|0.0001|TWO_SIDED|95.0|27.972|75.299|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||75.299|27.972|<0.0001
91789717|NCT00420641|183458935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0|TWO_SIDED|90.0|-0.76|-0.28|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CGI-S score at Week 10.||-0.28|-0.76|0.000
91789718|NCT00420641|183458936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76||||0.516|TWO_SIDED|90.0|-2.71|6.24|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MEI total score at Week 10.||6.24|-2.71|0.516
91789719|NCT00420641|183458936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22||||0.016|TWO_SIDED|90.0|1.97|10.48|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MEI total score at Week 10.||10.48|1.97|0.016
91612799|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|12.87|||<|0.001|TWO_SIDED|95.0|5.463|30.317|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||30.317|5.463|<0.001
91612800|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|11.46|||<|0.001|TWO_SIDED|95.0|4.863|26.986|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||26.986|4.863|<0.001
91612801|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.058|TWO_SIDED|95.0|0.971|6.024|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.024|0.971|0.058
91789720|NCT00420641|183458937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.126|TWO_SIDED|90.0|-0.13|3.57|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.||3.57|-0.13|0.126
91789721|NCT00420641|183458937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.957|TWO_SIDED|90.0|-1.69|1.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.||1.81|-1.69|0.957
91789722|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.5061|TWO_SIDED|90.0|0.21|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 1.||1.93|0.21|0.5061
91789723|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.7398|TWO_SIDED|90.0|0.46|3.25|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 1.||3.25|0.46|0.7398
91789724|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9209|TWO_SIDED|90.0|0.52|2.08|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 2.||2.08|0.52|0.9209
91789725|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2908|TWO_SIDED|90.0|0.78|3.13|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 2.||3.13|0.78|0.2908
91789726|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0086|TWO_SIDED|90.0|0.23|0.72|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 3.||0.72|0.23|0.0086
91789727|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8087|TWO_SIDED|90.0|0.64|1.83|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 3.||1.83|0.64|0.8087
91789728|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||0.0002|TWO_SIDED|90.0|0.18|0.52|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 4.||0.52|0.18|0.0002
91789729|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4606|TWO_SIDED|90.0|0.78|1.94|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 4.||1.94|0.78|0.4606
91789730|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1399|TWO_SIDED|90.0|0.4|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 5.||1.05|0.40|0.1399
91789731|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0461|TWO_SIDED|90.0|1.1|2.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 5.||2.73|1.10|0.0461
91789732|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.14|TWO_SIDED|90.0|0.41|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 6.||1.05|0.41|0.1400
91789733|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.0002|TWO_SIDED|90.0|1.74|4.21|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 6.||4.21|1.74|0.0002
91789734|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9596|TWO_SIDED|90.0|0.59|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 8.||1.64|0.59|0.9596
91789735|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24||||0|TWO_SIDED|90.0|2.01|5.23|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 8.||5.23|2.01|0.0000
91789736|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.653|TWO_SIDED|90.0|0.69|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 10.||1.93|0.69|0.6530
91789737|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.48||||0|TWO_SIDED|90.0|2.11|5.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 10.||5.73|2.11|0.0000
91524098|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|7.99||||0.261|TWO_SIDED|95.0|-5.85|21.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.84|-5.85|0.261
91524099|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|62.88|||<|0.001|TWO_SIDED|95.0|51.78|73.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.99|51.78|<0.001
91654851|NCT02581345|183202176|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:\[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|95.0|-0.004|0.162||||||||0.162|-0.004|
91789738|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8844|TWO_SIDED|90.0|0.23|3.48|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 1.||3.48|0.23|0.8844
91789739|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.7425|TWO_SIDED|90.0|0.36|4.68|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 1.||4.68|0.36|0.7425
91789740|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8355|TWO_SIDED|90.0|0.39|2.07|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 2.||2.07|0.39|0.8355
91524100|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|66.24|||<|0.001|TWO_SIDED|95.0|53.77|78.71||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.71|53.77|<0.001
91654852|NCT02433665|183202273|NON_INFERIORITY|The primary end point for this study was a comparison between fixed-dose and customized-dose contrast material injection CT protocols for vascular and parenchymal enhancement by using a noninferiority approach. The limit of noninferiority was set at 0.1 before the initiation of the study on the basis of a similar study that examined contrast media dose optimization for CT angiography examinations.|Odds Ratio, log|0.75|STANDARD_DEVIATION|0.35|>|0.05|TWO_SIDED|0.38|||||Mixed Models Analysis|||||||>0.05
91654853|NCT02456532|183202274|OTHER|analyses of variance comparing the three treatment gropus|||||=|0.05|||||||ANOVA|||||||=0.05
91524101|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|4.38||||0.522|TWO_SIDED|95.0|-8.89|17.64||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.64|-8.89|0.522
91524102|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|61.93|||<|0.001|TWO_SIDED|95.0|49.06|74.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.80|49.06|<0.001
91524103|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|66.35|||<|0.001|TWO_SIDED|95.0|53.61|79.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.09|53.61|<0.001
91524104|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.415|TWO_SIDED|95.0|-7.53|18.44||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.44|-7.53|0.415
91524105|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|60.92|||<|0.001|TWO_SIDED|95.0|47.65|74.19||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.19|47.65|<0.001
91654854|NCT02456532|183202275|OTHER|ANOVA|||||=|0.643|||||||ANOVA|||||||=0.643
91654855|NCT02750761|183202290|OTHER|Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.|Geometric Least Squares Mean Ratio|1.12|||||TWO_SIDED|90.0|0.93|1.35|||||The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.|||1.35|0.93|
91654856|NCT01860976|183202294|SUPERIORITY_OR_OTHER_LEGACY||Estimate of Difference|17.2|||<|0.001|TWO_SIDED|95.0|8.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|8.7|<0.001
91612802|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|0.75||||0.526|TWO_SIDED|95.0|0.315|1.805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.805|0.315|0.526
91612803|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|55.53|||<|0.001|TWO_SIDED|95.0|23.49|131.279|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||131.279|23.490|<0.001
91612804|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|11.78|||<|0.001|TWO_SIDED|95.0|5.0|27.755|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.755|5.000|<0.001
91612805|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|23.17|||<|0.001|TWO_SIDED|95.0|9.833|54.579|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||54.579|9.833|<0.001
91613876|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.176|||<|0.0001|TWO_SIDED|95.0|20.129|51.434|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||51.434|20.129|<0.0001
91789741|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.1786|TWO_SIDED|90.0|0.86|4.32|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 2.||4.32|0.86|0.1786
91789742|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0835|TWO_SIDED|90.0|0.26|0.97|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 3.||0.97|0.26|0.0835
91613877|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.928|||<|0.0001|TWO_SIDED|95.0|4.291|11.188|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.188|4.291|<0.0001
91789743|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8558|TWO_SIDED|90.0|0.58|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 3.||1.98|0.58|0.8558
91789744|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.0067|TWO_SIDED|90.0|0.2|0.67|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 4.||0.67|0.20|0.0067
91789745|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6647|TWO_SIDED|90.0|0.67|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 4.||1.98|0.67|0.6647
91789746|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9553|TWO_SIDED|90.0|0.55|1.74|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 5.||1.74|0.55|0.9553
91789747|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.004||90.0|1.5|4.42|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 5.||4.42|1.50|0.0040
91789748|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6327|TWO_SIDED|90.0|0.52|1.43|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 6.||1.43|0.52|0.6327
91789749|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0027|TWO_SIDED|90.0|1.47|3.79|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 6.||3.79|1.47|0.0027
91789750|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3961|TWO_SIDED|90.0|0.45|1.29|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 8.||1.29|0.45|0.3961
91789751|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0298|TWO_SIDED|90.0|1.17|3.06|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 8.||3.06|1.17|0.0298
91789752|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8826|TWO_SIDED|90.0|0.56|1.61|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 10.||1.61|0.56|0.8826
91612806|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|11.05|||<|0.001|TWO_SIDED|95.0|4.516|27.052|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.052|4.516|<0.001
91612807|NCT03151148|183119874|SUPERIORITY||Geometric mean ratio (GMR)|2.43||||0.042|TWO_SIDED|95.0|1.031|5.724|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.724|1.031|0.042
91654857|NCT00810368|183202370|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.|t-test, 2 sided|Paired t-test||Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).||||0.30
91654858|NCT00810368|183202370|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
91654859|NCT00810368|183202371|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.|Fisher Exact|2 by 2 Fisher's Exact Test||||||0.018
91654860|NCT00810368|183202372|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||t-test, 2 sided|||||||0.0018
91654861|NCT00810368|183202372|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
91654862|NCT00810368|183202374|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
91654863|NCT00810368|183202375|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
91524106|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|65.32|||<|0.001|TWO_SIDED|95.0|52.18|78.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.46|52.18|<0.001
91524107|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|4.21||||0.519|TWO_SIDED|95.0|-8.39|16.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.81|-8.39|0.519
91524108|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91524109|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91524110|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91524111|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91612808|NCT03918642|183119881|SUPERIORITY||Mean Difference (Net)|-1.59|||<|0.001|TWO_SIDED|95.0|-2.35|-0.83|||Mixed Models Analysis|||||-0.83|-2.35|<0.001
91612809|NCT03918642|183119882|SUPERIORITY||Mean Difference (Net)|-1.01||||0.01|TWO_SIDED|95.0|-1.78|-0.24|||Mixed Models Analysis|||||-0.24|-1.78|0.01
91612810|NCT03918642|183119883|SUPERIORITY||Mean Difference (Net)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||||0.45|0.12|<0.001
91612811|NCT03918642|183119884|SUPERIORITY||Mean Difference (Net)|-1.42||||0.14|TWO_SIDED|95.0|-3.3|0.46|||Mixed Models Analysis|||||0.46|-3.30|0.14
91612812|NCT03918642|183119885|SUPERIORITY||Mean Difference (Net)|0.21||||0.85|TWO_SIDED|95.0|-1.99|2.42|||Mixed Models Analysis|||||2.42|-1.99|0.85
91612813|NCT03918642|183119886|SUPERIORITY||Mean Difference (Net)|-3.06||||0.03|TWO_SIDED|95.0|-5.88|-0.25|||Mixed Models Analysis|||||-0.25|-5.88|0.03
91612814|NCT03918642|183119887|SUPERIORITY||Mean Difference (Net)|-2.39||||0.02|TWO_SIDED|95.0|-4.33|-0.45|||Mixed Models Analysis|||||-0.45|-4.33|0.02
91654864|NCT00810368|183202376|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
91612815|NCT03918642|183119888|SUPERIORITY||Mean Difference (Net)|-2.49||||0.006|TWO_SIDED|95.0|-4.3|-0.68|||Mixed Models Analysis|||||-0.68|-4.30|0.006
91612816|NCT03918642|183119889|SUPERIORITY||Mean Difference (Net)|-1.95||||0.11|TWO_SIDED|95.0|-4.34|0.45|||Mixed Models Analysis|||||0.45|-4.34|0.11
91612817|NCT03918642|183119890|SUPERIORITY||Mean Difference (Net)|-4.39||||0.03|TWO_SIDED|95.0|-8.44|-0.34|||Mixed Models Analysis|||||-0.34|-8.44|0.03
91612818|NCT03918642|183119891|SUPERIORITY||Mean Difference (Net)|-3.76||||0.07|TWO_SIDED|95.0|-7.83|0.32|||Mixed Models Analysis|||||0.32|-7.83|0.07
91612819|NCT03918642|183119892|SUPERIORITY||Mean Difference (Net)|1.23||||0.005|TWO_SIDED|95.0|0.36|2.1|||Mixed Models Analysis|||||2.10|0.36|0.005
91612820|NCT03918642|183119893|SUPERIORITY||Mean Difference (Net)|0.95||||0.17|TWO_SIDED|95.0|-0.4|2.29|||Mixed Models Analysis|||||2.29|-0.40|0.17
91612821|NCT03918642|183119894|SUPERIORITY||Mean Difference (Net)|-1.85||||0.11|TWO_SIDED|95.0|-4.14|0.44|||Mixed Models Analysis|||||0.44|-4.14|0.11
91612822|NCT03918642|183119895|SUPERIORITY||Mean Difference (Net)|-2.57||||0.11|TWO_SIDED|95.0|-5.73|0.6|||Mixed Models Analysis|||||0.60|-5.73|0.11
91654865|NCT02362594|183202388|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|98.4|0.43|0.74||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.74|0.43|<0.0001
91789753|NCT00420641|183458941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0022|TWO_SIDED|90.0|1.52|4.05|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 10.||4.05|1.52|0.0022
91612823|NCT03918642|183119896|SUPERIORITY||Mean Difference (Net)|-0.78||||0.33|TWO_SIDED|95.0|-2.33|0.78|||Mixed Models Analysis|||||0.78|-2.33|0.33
91612824|NCT03918642|183119897|SUPERIORITY||Mean Difference (Net)|-0.3||||0.69|TWO_SIDED|95.0|-1.74|1.14|||Mixed Models Analysis|||||1.14|-1.74|0.69
91612825|NCT03918642|183119898|SUPERIORITY||Mean Difference (Net)|1.46|||<|0.001|TWO_SIDED|95.0|0.77|2.15|||Mixed Models Analysis|||||2.15|0.77|<0.001
91612826|NCT03918642|183119899|SUPERIORITY||Mean Difference (Net)|1.24|||<|0.001|TWO_SIDED|95.0|0.62|1.86|||Mixed Models Analysis|||||1.86|0.62|<0.001
91612827|NCT03918642|183119900|SUPERIORITY||Odds Ratio (OR)|21.54|||<|0.001|TWO_SIDED|95.0|4.66|99.56|||Mixed Models Analysis|||||99.56|4.66|<0.001
91612828|NCT03918642|183119901|SUPERIORITY||Odds Ratio (OR)|7.24||||0.006|TWO_SIDED|95.0|1.74|30.06|||Mixed Models Analysis|||||30.06|1.74|0.006
91612829|NCT03918642|183119902|SUPERIORITY||Odds Ratio (OR)|11.77||||0.002|TWO_SIDED|95.0|2.38|58.25|||Mixed Models Analysis|||||58.25|2.38|0.002
91612830|NCT03918642|183119903|SUPERIORITY||Odds Ratio (OR)|6.58||||0.05|TWO_SIDED|95.0|0.99|43.67|||Mixed Models Analysis|||||43.67|0.99|0.05
91612831|NCT03918642|183119904|SUPERIORITY||Odds Ratio (OR)|13.93||||0.06|TWO_SIDED|95.0|0.86|225.44|||Mixed Models Analysis|||||225.44|0.86|0.06
91612832|NCT03918642|183119905|SUPERIORITY||Odds Ratio (OR)|5.61||||0.22|TWO_SIDED|95.0|0.35|89.3|||Mixed Models Analysis|||||89.30|0.35|0.22
91612833|NCT03046472|183119911|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91612834|NCT03046472|183119912|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91612835|NCT03046472|183119913|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91612836|NCT04985799|183119928|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|14.8||||0.04|TWO_SIDED|95.0|1.1|28.5|||Chi-squared|||||28.5|1.1|0.04
91612837|NCT04985799|183119929|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|7.4||||0.29|TWO_SIDED|95.0|-6.2|21.1|||Chi-squared|||||21.1|-6.2|0.29
91612838|NCT04985799|183119931|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
91612839|NCT03864237|183119948|SUPERIORITY||beta coefficient for condition|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.568|TWO_SIDED|95.0|-1.31|2.37|||Regression, Linear|Regression controls for baseline value of outcome and sex to determine pre-post change in the outcome as a function of condition.||||2.37|-1.31|0.568
91612840|NCT03864237|183119949|SUPERIORITY||beta coefficient for condition|1.22|STANDARD_ERROR_OF_MEAN|0.69||0.077|TWO_SIDED|95.0|-0.13|2.59|||Regression, Linear|||||2.59|-0.13|0.077
91789754|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.5072|TWO_SIDED|90.0|0.22|1.89|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 1.||1.89|0.22|0.5072
91789755|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6886|TWO_SIDED|90.0|0.52|2.93|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 1.||2.93|0.52|0.6886
91789756|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8664|TWO_SIDED|90.0|0.56|2.04|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 2.||2.04|0.56|0.8664
91789757|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2897|TWO_SIDED|90.0|0.8|2.79|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 2.||2.79|0.80|0.2897
91612841|NCT03864237|183119950|SUPERIORITY||beta coefficient for condition|-1.21|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-3.52|1.11|||Regression, Linear|||||1.11|-3.52|0.30
91524112|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91612842|NCT03864237|183119951|SUPERIORITY||beta coefficient for condition|0.84|STANDARD_ERROR_OF_MEAN|1.09||0.44|TWO_SIDED|95.0|-1.31|3.0|||Regression, Linear|||||3.0|-1.31|0.44
91612843|NCT03864237|183119952|SUPERIORITY||Beta coefficient for condition|-0.25|STANDARD_ERROR_OF_MEAN|1.29||0.845|TWO_SIDED|95.0|-2.81|2.3|||Regression, Linear|||||2.30|-2.81|0.845
91612844|NCT03864237|183119953|SUPERIORITY||Beta coefficient for condition|0.3|STANDARD_ERROR_OF_MEAN|1.01||0.77|TWO_SIDED|95.0|-1.72|2.31|||Regression, Linear|||||2.31|-1.72|0.77
91789758|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2474|TWO_SIDED|90.0|0.39|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 3.||1.18|0.39|0.2474
91612845|NCT03864237|183119954|SUPERIORITY||Beta coefficient for condition|1.77|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-1.0|4.54|||Regression, Linear|||||4.54|-1.0|0.21
91612846|NCT01035606|183119985|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
91612847|NCT01035606|183119986|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
91612848|NCT01809262|183120012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0005||95.0|0.031|0.109|||ANCOVA|||||0.109|0.031|0.0005
91612849|NCT01809262|183120012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.06|0.138|||ANCOVA|||||0.138|0.060|<0.0001
91612850|NCT01809262|183120012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.074|0.152|||ANCOVA|||||0.152|0.074|<0.0001
91612851|NCT01809262|183120012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.158|||ANCOVA|||||0.158|0.080|<0.0001
91612852|NCT01809262|183120013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.077|0.139|||ANCOVA|||||0.139|0.077|<0.0001
91612853|NCT01809262|183120013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.124|0.186|||ANCOVA|||||0.186|0.124|<0.0001
91612854|NCT01809262|183120013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.13|0.192|||ANCOVA|||||0.192|0.130|<0.0001
91612855|NCT01809262|183120013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.161|0.223|||ANCOVA|||||0.223|0.161|<0.0001
91612856|NCT01809262|183120014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.068|0.131|||ANCOVA|||||0.131|0.068|<0.0001
91612857|NCT01809262|183120014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.107|0.171|||ANCOVA|||||0.171|0.107|<0.0001
91789759|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.2007|TWO_SIDED|90.0|0.89|2.47|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 3.||2.47|0.89|0.2007
91789760|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.0214|TWO_SIDED|90.0|0.29|0.82|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 4.||0.82|0.29|0.0214
91612858|NCT01809262|183120014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.122|0.185|||ANCOVA|||||0.185|0.122|<0.0001
91612859|NCT01809262|183120014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.152|0.215|||ANCOVA|||||0.215|0.152|<0.0001
91612860|NCT01809262|183120015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.056|0.117|||ANCOVA|||||0.117|0.056|<0.0001
91612861|NCT01809262|183120015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.087|0.148|||ANCOVA|||||0.148|0.087|<0.0001
91612862|NCT01809262|183120015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.107|0.168|||ANCOVA|||||0.168|0.107|<0.0001
91612863|NCT01809262|183120015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.132|0.193|||ANCOVA|||||0.193|0.132|<0.0001
91612864|NCT01809262|183120016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.041|0.108|||ANCOVA|||||0.108|0.041|<0.0001
91612865|NCT01809262|183120016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.096|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.062|0.13|||ANCOVA|||||0.130|0.062|<0.0001
91612866|NCT01809262|183120016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.089|0.156|||ANCOVA|||||0.156|0.089|<0.0001
91612867|NCT01809262|183120016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.107|0.174|||ANCOVA|||||0.174|0.107|<0.0001
91612868|NCT01809262|183120017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.084|0.158|||ANCOVA|||||0.158|0.084|<0.0001
91612869|NCT01809262|183120017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.129|0.203|||ANCOVA|||||0.203|0.129|<0.0001
91612870|NCT01809262|183120017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||ANCOVA|||||0.214|0.139|<0.0001
91612871|NCT01809262|183120017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||ANCOVA|||||0.250|0.176|<0.0001
91612872|NCT01809262|183120018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.306|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.21|0.402|||ANCOVA|||||0.402|0.210|<0.0001
91789761|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.2368|TWO_SIDED|90.0|0.88|2.23|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 4.||2.23|0.88|0.2368
91789762|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.987|TWO_SIDED|90.0|0.63|1.59|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 5.||1.59|0.63|0.9870
91612873|NCT01809262|183120018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.258|0.452|||ANCOVA|||||0.452|0.258|<0.0001
91789763|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.0193|TWO_SIDED|90.0|1.21|3.0|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 5.||3.00|1.21|0.0193
91789764|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8351|TWO_SIDED|90.0|0.59|1.5|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 6.||1.50|0.59|0.8351
91789765|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.0001|TWO_SIDED|90.0|1.9|4.77|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 6.||4.77|1.90|0.0001
91789766|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.751|TWO_SIDED|90.0|0.67|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 8.||1.80|0.67|0.7510
91789767|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.0029|TWO_SIDED|90.0|1.47|3.8|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 8.||3.80|1.47|0.0029
91789768|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1707|TWO_SIDED|90.0|0.92|2.55|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 10.||2.55|0.92|0.1707
91789769|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.0001|TWO_SIDED|90.0|1.99|5.36|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 10.||5.36|1.99|0.0001
91789770|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.205|TWO_SIDED|90.0|0.05|1.48|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 1.||1.48|0.05|0.2050
91789771|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.1735|TWO_SIDED|90.0|0.11|1.24|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 1.||1.24|0.11|0.1735
91789772|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.2305|TWO_SIDED|90.0|0.78|4.75|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 2.||4.75|0.78|0.2305
91789773|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.2507|TWO_SIDED|90.0|0.77|4.5|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 2.||4.50|0.77|0.2507
91789774|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5608|TWO_SIDED|90.0|0.35|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 3.||1.64|0.35|0.5608
91789775|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.6526|TWO_SIDED|90.0|0.6|2.42|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 3.||2.42|0.60|0.6526
91789776|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0208|TWO_SIDED|90.0|0.21|0.77|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 4.||0.77|0.21|0.0208
91789777|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2859|TWO_SIDED|90.0|0.39|1.22|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 4.||1.22|0.39|0.2859
91789778|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.7921|TWO_SIDED|90.0|0.49|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 5.||1.66|0.49|0.7921
91789779|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.362|TWO_SIDED|90.0|0.79|2.31|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 5.||2.31|0.79|0.3620
91789780|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.4331|TWO_SIDED|90.0|0.44|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 6.||1.34|0.44|0.4331
91789781|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.0047|TWO_SIDED|90.0|1.42|3.75|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 6.||3.75|1.42|0.0047
91789782|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4431|TWO_SIDED|90.0|0.46|1.32|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 8.||1.32|0.46|0.4431
91789783|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1901|TWO_SIDED|90.0|0.9|2.44|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 8.||2.44|0.90|0.1901
91789784|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9222|TWO_SIDED|90.0|0.56|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 10.||1.66|0.56|0.9222
91654866|NCT02362594|183202389|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.69||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.69|0.42|<0.0001
91654867|NCT03365375|183202421|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
91654868|NCT01807871|183202464|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
91654869|NCT01807871|183202466|SUPERIORITY|||||||0.24|||||||Chi-squared|||Comparison of number of participants who reported removing the nicotine patch due to a side effect||||0.24
91789785|NCT00420641|183458942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1665|TWO_SIDED|90.0|0.93|2.43|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 10.||2.43|0.93|0.1665
91654870|NCT03019965|183202467|SUPERIORITY||Risk Ratio (RR)|0.95||||0.156|TWO_SIDED|95.0|0.87|1.02|||Chi-squared||||The efficacy of the maneuver was evaluated by calculating the absolute risk reduction and the number needed to treat.|1.02|0.87|0.156
91654871|NCT03019965|183202468|SUPERIORITY||Risk Ratio (RR)|2.98||||0.722|TWO_SIDED|95.0|0.31|28.45|||Chi-squared|||||28.45|0.31|0.722
91654872|NCT01569451|183202480|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Chi-squared|||||||0.0493
91654873|NCT01569451|183202481|SUPERIORITY_OR_OTHER|||||||0.0268|||||||Peto|||||||0.0268
91654874|NCT01569451|183202482|SUPERIORITY_OR_OTHER|||||||0.0189|||||||Chi-squared|||||||0.0189
91654875|NCT01569451|183202483|SUPERIORITY_OR_OTHER|||||||0.3167|||||||Chi-squared|||||||0.3167
91654876|NCT01569451|183202484|SUPERIORITY_OR_OTHER|||||||0.094|||||||Chi-squared|||||||0.0940
91789786|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.5057|TWO_SIDED|90.0|0.2|1.98|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 1.||1.98|0.20|0.5057
91789787|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8633|TWO_SIDED|90.0|0.38|3.3|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 1.||3.30|0.38|0.8633
91789788|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.8428|TWO_SIDED|90.0|0.55|2.16|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 2.||2.16|0.55|0.8428
91789789|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.3416|TWO_SIDED|90.0|0.76|2.84|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 2.||2.84|0.76|0.3416
91789790|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3287|TWO_SIDED|90.0|0.4|1.26|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 3.||1.26|0.40|0.3287
91789791|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2112|TWO_SIDED|90.0|0.88|2.57|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 3.||2.57|0.88|0.2112
91789792|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.0134|TWO_SIDED|90.0|0.26|0.76|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 4.||0.76|0.26|0.0134
91789793|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.3412|TWO_SIDED|90.0|0.81|2.17|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 4.||2.17|0.81|0.3412
91789794|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8434|TWO_SIDED|90.0|0.58|1.54|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 5.||1.54|0.58|0.8434
91789795|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0819|TWO_SIDED|90.0|1.03|2.63|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 5.||2.63|1.03|0.0819
91612874|NCT01809262|183120018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.253|0.447|||ANCOVA|||||0.447|0.253|<0.0001
91612875|NCT01809262|183120018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.359|0.551|||ANCOVA|||||0.551|0.359|<0.0001
91612876|NCT00859898|183120044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1056|<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.32|-0.74|<0.0001
91612877|NCT00859898|183120044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1072|<|0.0001|TWO_SIDED|95.0|-0.75|-0.33||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.33|-0.75|<0.0001
91612878|NCT00859898|183120044|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change in HbA1c from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 0.35%.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054|||TWO_SIDED|95.0|-0.22|0.2|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||0.20|-0.22|
91710544|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.15|0.25|||t-test, 2 sided|||FEV1 Day 1 (1 hrs post-dose)||0.25|0.15|<0.0001
91789796|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2832|TWO_SIDED|90.0|0.44|1.19|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 6.||1.19|0.44|0.2832
91789797|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0016|TWO_SIDED|90.0|1.54|3.97|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 6.||3.97|1.54|0.0016
91789798|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9727|TWO_SIDED|90.0|0.6|1.63|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 8.||1.63|0.60|0.9727
91612879|NCT00859898|183120044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054||0.9144|TWO_SIDED|95.0|-0.22|0.2||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||0.20|-0.22|0.9144
91613878|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.733||||0.0204|TWO_SIDED|95.0|0.564|0.953|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.564|0.0204
91613879|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.087|0.331|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.331|0.087|<0.0001
91613880|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.806||||0.001|TWO_SIDED|95.0|1.514|5.201|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.201|1.514|0.0010
91613881|NCT01070550|183121710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.0459|TWO_SIDED|95.0|0.443|0.993|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.443|0.0459
91789799|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|90.0|1.6|4.13|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 8.||4.13|1.60|0.0010
91789800|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8312|TWO_SIDED|90.0|0.64|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 10.||1.80|0.64|0.8312
91789801|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06||||0.0002|TWO_SIDED|90.0|1.86|5.02|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 10.||5.02|1.86|0.0002
91789802|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.553|TWO_SIDED|90.0|0.13|2.6|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 1.||2.60|0.13|0.5530
91789803|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.978|TWO_SIDED|90.0|0.28|3.41|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 1.||3.41|0.28|0.9780
91789804|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8312|TWO_SIDED|90.0|0.43|3.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 2.||3.03|0.43|0.8312
91789805|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.1881|TWO_SIDED|90.0|0.83|5.25|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 2.||5.25|0.83|0.1881
91789806|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.6384|TWO_SIDED|90.0|0.39|1.69|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 3.||1.69|0.39|0.6384
91789807|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.216|TWO_SIDED|90.0|0.84|3.37|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 3.||3.37|0.84|0.2160
91654877|NCT01569451|183202485|SUPERIORITY_OR_OTHER|||||||0.3507|||||||Fisher Exact|||||||0.3507
91654878|NCT01569451|183202486|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91710545|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.13|0.24|||t-test, 2 sided|||FEV1 Day 1 (2 hrs post-dose)||0.24|0.13|<0.0001
91789808|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0259|TWO_SIDED|90.0|0.2|0.79|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 4.||0.79|0.20|0.0259
91612880|NCT00859898|183120045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.558|<|0.0001|TWO_SIDED|95.0|-20.9|-7.0||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-7.0|-20.9|<0.0001
91612881|NCT00859898|183120045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-32.6|-18.5||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-18.5|-32.6|<0.0001
91612882|NCT00859898|183120045|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change FPG from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 15 mg/dL.|Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566|||TWO_SIDED|95.0|-18.6|-4.6|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||-4.6|-18.6|
91654879|NCT01569451|183202487|SUPERIORITY_OR_OTHER|||||||0.4904|||||||t-test, 2 sided|||T-test||||0.4904
91654880|NCT01569451|183202488|SUPERIORITY_OR_OTHER|||||||0.4073|||||||Chi-squared|||||||0.4073
91654881|NCT01569451|183202489|SUPERIORITY_OR_OTHER|||||||0.8677|||||||Mixed Models Analysis|||||||0.8677
91654882|NCT01569451|183202490|OTHER|Mean difference between treatment groups.||||||0.3974|||||||t-test, 2 sided|||||||0.3974
91654883|NCT01890915|183202491|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||"Due to impaired thermoregulatory mechanisms secondary to spinal cord injury, subjects with tetraplegia were hypothesized to have a significant rise in core temperature after exposure to warm ambient temperatures, while control subjects were hypothesized to maintain constant core temperature.~Percent change in core temperature of subjects in each group were compared to determine if they were significantly different from baseline to warm exposure."||||0.0001
91654884|NCT01890915|183202492|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||We hypothesized that subjects with tetraplegia would demonstrate a change in cognitive performance after heat exposure if they had demonstrated a significant increase in core body temperature - as was hypothesized in our primary hypothesis. Cognitive performance was measured, in part, by Interference T-scores derived from the Stroop Color and Word Test.||||0.006
91789809|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.3959|TWO_SIDED|90.0|0.39|1.35|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 4.||1.35|0.39|0.3959
91789810|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.3857|TWO_SIDED|90.0|0.39|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 5.||1.34|0.39|0.3857
91789811|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.3126|TWO_SIDED|90.0|0.8|2.52|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 5.||2.52|0.80|0.3126
91789812|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.1182|TWO_SIDED|90.0|0.36|1.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 6.||1.03|0.36|0.1182
91789813|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0125|TWO_SIDED|90.0|1.29|3.43|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 6.||3.43|1.29|0.0125
91789814|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2147|TWO_SIDED|90.0|0.42|1.13|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 8.||1.13|0.42|0.2147
91789815|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0783|TWO_SIDED|90.0|1.03|2.69|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 8.||2.69|1.03|0.0783
91789816|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9067||90.0|0.57|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 10.||1.64|0.57|0.9067
91789817|NCT00420641|183458943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0328|TWO_SIDED|90.0|1.15|2.92|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 10.||2.92|1.15|0.0328
91789818|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6928|TWO_SIDED|90.0|0.44|3.76|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.||3.76|0.44|0.6928
91612883|NCT00859898|183120045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566||0.0012|TWO_SIDED|95.0|-18.6|-4.6||two-sided significance level at α=0.05.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||-4.6|-18.6|0.0012
91612884|NCT00859898|183120046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|4.598||0.0012|TWO_SIDED|95.0|5.9|23.9||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.9|5.9|0.0012
91612885|NCT00859898|183120046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|4.73||0.0165|TWO_SIDED|95.0|2.1|20.6||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||20.6|2.1|0.0165
91612886|NCT00859898|183120047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1807||0.0133|TWO_SIDED|95.0|-0.81|-0.09||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|: treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.09|-0.81|0.0133
91612887|NCT00859898|183120047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1817||0.0036|TWO_SIDED|95.0|-0.89|-0.18||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.18|-0.89|0.0036
91612888|NCT00859898|183120048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3401|<|0.0001|TWO_SIDED|95.0|-2.64|-1.3||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-1.30|-2.64|<0.0001
91612889|NCT00859898|183120048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|-2.03|-0.71||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate||Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.71|-2.03|<0.0001
91612890|NCT02145156|183120057|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||.36
91612891|NCT02145156|183120057|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||||||.18
91612892|NCT02145156|183120057|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||.22
91612893|NCT02145156|183120057|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
91612894|NCT02145156|183120058|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||||||0.35
91612895|NCT02145156|183120058|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91612896|NCT02145156|183120058|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
91612897|NCT02145156|183120058|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
91612898|NCT02145156|183120059|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
91612899|NCT02145156|183120059|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
91612900|NCT02145156|183120059|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
91612901|NCT02145156|183120059|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
91612902|NCT02145156|183120060|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
91612903|NCT02145156|183120060|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||||||.52
91612904|NCT02145156|183120060|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher Exact|||||||.71
91612905|NCT02145156|183120060|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
91612906|NCT02145156|183120061|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
91612907|NCT02145156|183120061|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||.15
91612908|NCT02145156|183120061|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||||||.98
91612909|NCT02145156|183120061|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
91612910|NCT02145156|183120062|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
91612911|NCT02145156|183120062|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
91612912|NCT02145156|183120062|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
91612913|NCT02145156|183120062|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
91524113|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91789819|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.3039|TWO_SIDED|90.0|0.69|5.01|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.||5.01|0.69|0.3039
91524114|NCT01216163|182923474|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91612914|NCT02145156|183120063|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||||||0.87
91789820|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.1938|TWO_SIDED|90.0|0.89|2.7|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.||2.70|0.89|0.1938
91612915|NCT02145156|183120063|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
91789821|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.06|TWO_SIDED|90.0|1.08|3.16|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.||3.16|1.08|0.0600
91789822|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8989|TWO_SIDED|90.0|0.61|1.53|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.||1.53|0.61|0.8989
91789823|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.0136|TWO_SIDED|90.0|1.25|3.05|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.||3.05|1.25|0.0136
91789824|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3099|TWO_SIDED|90.0|0.5|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.||1.18|0.50|0.3099
91789825|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1137|TWO_SIDED|90.0|0.98|2.27|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.||2.27|0.98|0.1137
91789826|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8682||90.0|0.67|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.||1.64|0.67|0.8682
91789827|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.0006|TWO_SIDED|90.0|1.63|4.03|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.||4.03|1.63|0.0006
91789828|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8992|TWO_SIDED|90.0|0.62|1.51|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.||1.51|0.62|0.8992
91789829|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0004|TWO_SIDED|90.0|1.67|4.09|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.||4.09|1.67|0.0004
91789830|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.28|TWO_SIDED|90.0|0.85|2.23|||Placebo versus GSK372475 in percentage o|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.||2.23|0.85|0.2800
91789831|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0|TWO_SIDED|90.0|2.24|6.08|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.||6.08|2.24|0.0000
91789832|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.0507|TWO_SIDED|90.0|1.1|3.13|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.||3.13|1.10|0.0507
91789833|NCT00420641|183458944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97||||0.0003|TWO_SIDED|90.0|1.81|4.88|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.||4.88|1.81|0.0003
91789834|NCT00420641|183458945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8782|TWO_SIDED|90.0|0.62|1.5|||Regression, Logistic|||Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.||1.50|0.62|0.8782
91789835|NCT00420641|183458945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0011|TWO_SIDED|90.0|1.56|3.86|||Regression, Logistic|||Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.||3.86|1.56|0.0011
91789836|NCT02815280|183458955|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|1.12||0.0051|TWO_SIDED|95.0|0.95|5.35|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, baseline inflammatory lesion count and pooled investigational site as a blocking factor.||5.35|0.95|0.0051
91789837|NCT02815280|183458956|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0.|Risk ratio|1.88|STANDARD_ERROR_OF_MEAN|0.31||0.0424|TWO_SIDED|95.0|1.02|3.46|||Mantel Haenszel|||||3.46|1.02|0.0424
91789838|NCT02815280|183458957|SUPERIORITY||Mean Difference (Final Values)|12.84|STANDARD_ERROR_OF_MEAN|5.3||0.0155|TWO_SIDED|95.0|2.44|23.23||Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|ANCOVA|||||23.23|2.44|0.0155
91789839|NCT02815280|183458958|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.89|STANDARD_ERROR_OF_MEAN|1.03||0.0001|TWO_SIDED|95.0|1.88|5.9|||ANCOVA|||||5.90|1.88|0.0001
91789840|NCT02815280|183458958|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.78|STANDARD_ERROR_OF_MEAN|1.11||0.0007|TWO_SIDED|95.0|1.6|5.95|||ANCOVA|||||5.95|1.60|0.0007
91612916|NCT02145156|183120063|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||||||0.81
91612917|NCT02145156|183120063|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
91612918|NCT02145156|183120064|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||||||0.70
91612919|NCT02145156|183120064|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
91612920|NCT02145156|183120064|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
91612921|NCT02145156|183120064|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
91612922|NCT02145156|183120065|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
91789841|NCT02815280|183458959|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0. Percentage of participants achieving IGA treatment success at Week 6.|Risk Difference (RD)|3.87|STANDARD_ERROR_OF_MEAN|1.44||0.0071|TWO_SIDED|95.0|1.06|6.69|||Cochran-Mantel-Haenszel|||||6.69|1.06|0.0071
91524115|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|26.4|||<|0.001|TWO_SIDED|95.0|15.87|36.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.93|15.87|<0.001
91612923|NCT02145156|183120065|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
91612924|NCT02145156|183120065|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
91612925|NCT02145156|183120065|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
91612926|NCT02145156|183120066|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
91612927|NCT02145156|183120066|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
91612928|NCT02145156|183120066|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
91612929|NCT02145156|183120066|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
91612930|NCT02145156|183120067|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared|||||||0.09
91612931|NCT02145156|183120067|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
91612932|NCT02145156|183120067|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
91612933|NCT02145156|183120067|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
91612934|NCT02145156|183120068|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
91612935|NCT02145156|183120068|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
91612936|NCT02145156|183120068|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
91612937|NCT02145156|183120068|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
91612938|NCT02064439|183120071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.0001|TWO_SIDED|95.0|0.2|0.59||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.59|0.20|0.0001
91612939|NCT02064439|183120071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|98.0|0.14|0.47||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.47|0.14|<0.0001
91612940|NCT02064439|183120071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.4328|TWO_SIDED|95.0|0.65|2.75||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.75|0.65|0.4328
91612941|NCT02064439|183120072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.3235|TWO_SIDED|95.0|0.5|8.04||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||8.04|0.50|0.3235
91789842|NCT02815280|183458959|SUPERIORITY||Risk Difference (RD)|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.5143|TWO_SIDED|95.0|-3.3|6.58|||Cochran-Mantel-Haenszel|||||6.58|-3.30|0.5143
91789843|NCT00609362|183458968|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is un-adjusted. A priori threshold for significance: 0.05|t-test, 2 sided|||The minimum number of participants was determined by power calculations to be 44 (22 in each group), assuming a difference in change in BMD of 1.7%, a standard deviation of 2%, a power of 80%, and a level of significance of 5%.||||0.055
91789844|NCT00609362|183458969|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||t-test, 2 sided|||||||0.056
91789845|NCT00609362|183458970|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91789846|NCT05027971|183458981|OTHER||Proportion by cohort|0.02|||||TWO_SIDED|95.0|0.002|0.07||||||||.07|.002|
91789847|NCT05027971|183458982|OTHER||Proportion by cohort|0.03|||||TWO_SIDED|95.0|0.006|0.084||||||||.084|.006|
91789848|NCT05027971|183458983|OTHER||Proportion by cohort|0.667|||||TWO_SIDED|95.0|0.553|0.768||||||||.768|.553|
91789849|NCT05027971|183458984|OTHER||Mean Difference (Final Values)|-15.8|||||TWO_SIDED|95.0|-17.4|-14.2||||||||-14.2|-17.4|
91789850|NCT05027971|183458987|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
91789851|NCT05027971|183458988|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
91789852|NCT05027971|183458989|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
91789853|NCT05027971|183458990|OTHER||Proportion by cohort|0.889|||||TWO_SIDED|95.0|0.81|0.943||||||||.943|.810|
91789854|NCT05027971|183458991|OTHER||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|11.3|18.6||||||||18.6|11.3|
91789855|NCT05027971|183458992|OTHER||Mean Difference (Final Values)|-3.4|||||TWO_SIDED|95.0|-3.9|-2.9||||||||-2.9|-3.9|
91789856|NCT05027971|183458993|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
91789857|NCT02025556|183458994|SUPERIORITY||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-4.07|-1.55||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.55|-4.07|< .0001
91789858|NCT02025556|183458994|SUPERIORITY||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-3.9|-1.38||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.38|-3.9|< .0001
91654885|NCT01890915|183202493|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANOVA|||Due to impaired thermoregulatory mechanisms, subjects with tetraplegia were hypothesized to have diminished increases in sweat rate in comparison to controls after heat exposure.||||0.015
91789859|NCT02582684|183458999|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.9|||||TWO_SIDED|95.0|0.83|0.95|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.95|0.83|
91612942|NCT02064439|183120072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.5005|TWO_SIDED|95.0|0.39|6.84||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||6.84|0.39|0.5005
91612943|NCT02064439|183120072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.7337|TWO_SIDED|95.0|0.37|4.03||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||4.03|0.37|0.7337
91612944|NCT02064439|183120073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.57||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.57|0.20|<0.0001
91612945|NCT02064439|183120073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.19|0.54||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.54|0.19|<0.0001
91789860|NCT02582684|183459000|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|Proportion|0.89|||||TWO_SIDED|95.0|0.82|0.94|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.94|0.82|
91789861|NCT02582684|183459001|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.85|||||TWO_SIDED|95.0|0.77|0.91|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.91|0.77|
91789862|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.5888|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Hgb||||0.5888
91789863|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Weight||||0.6600
91612946|NCT02064439|183120073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.8172|TWO_SIDED|95.0|0.57|2.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.06|0.57|0.8172
91612947|NCT02064439|183120074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.3318|TWO_SIDED|95.0|0.69|3.02||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.02|0.69|0.3318
91612948|NCT02064439|183120074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9726|TWO_SIDED|95.0|0.44|2.2||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||2.20|0.44|0.9726
91612949|NCT02064439|183120074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.3137|TWO_SIDED|95.0|0.7|3.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.06|0.70|0.3137
91789864|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.7999|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline estimated glomerular filtration rate (eGFR)||||0.7999
91612950|NCT02433288|183120075|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
91612951|NCT02433288|183120076|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Chi-squared|||||||0.0017
91612952|NCT02433288|183120077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|STANDARD_ERROR_OF_MEAN|3.39|<|0.0001|TWO_SIDED|95.0|-26.91|-13.57|||t-test, 2 sided|||||-13.57|-26.91|<0.0001
91789865|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.2092|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Ethnicity||||0.2092
91789866|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.9996||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Geographic Ancestry||||0.9996
91789867|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Sex||||0.7002
91789868|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.5536||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Age||||0.5536
91789869|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Co-administration with food||||0.0085
91789870|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Diabetic||||0.0021
91789871|NCT01587898|183459015|SUPERIORITY_OR_OTHER|||||||0.2194||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Region||||0.2194
91789872|NCT00796991|183459063|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.794|1.168|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log(Cmax) using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1)||1.168|0.794|
91789873|NCT00796991|183459063|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.848|1.243|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on dacarbazine Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.243|0.848|
91789874|NCT00796991|183459063|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.058|||||TWO_SIDED|90.0|0.974|1.15|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on AIC Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.150|0.974|
91789875|NCT00796991|183459063|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934||||||90.0|0.768|1.136|||linear model|treatment arm as a fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
91789876|NCT00796991|183459063|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.798|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.798|
91789877|NCT00796991|183459067|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.068|||||TWO_SIDED|90.0|0.954|1.196|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1).||1.196|0.954|
91789878|NCT00796991|183459067|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.912|||||TWO_SIDED|90.0|0.757|1.099|||Mixed Models Analysis|A general linear mixed model was applied to dacarbazine log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on dacarbazine AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.099|0.757|
91789879|NCT00796991|183459067|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.891|1.056|||Mixed Models Analysis|A general linear mixed model was applied to active metabolite AIC log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on AUC(INF) for AIC. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.056|0.891|
91612953|NCT02433288|183120078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.6||0.3939|TWO_SIDED|95.0|-4.56|1.8|||t-test, 2 sided|||||1.80|-4.56|0.3939
91612954|NCT02433288|183120079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.99||0.7514|TWO_SIDED|95.0|-3.27|4.53|||ANCOVA|linear model including terms for randomized group and baseline LDL-C||||4.53|-3.27|0.7514
91612955|NCT00858702|183120088|SUPERIORITY_OR_OTHER|||||||0.0158||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0158
91612956|NCT00858702|183120089|SUPERIORITY_OR_OTHER|||||||0.0566||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0566
91789880|NCT00796991|183459067|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934|||||TWO_SIDED|90.0|0.768|1.136|||linear model|treatment arm as fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
91789881|NCT00796991|183459067|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.7981|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.7981|
91789882|NCT00796991|183459073|SUPERIORITY_OR_OTHER|||||||0.027||||||p-value was not corrected for multiple testing. F-statistic = 1.86.|conditional F test|15 degrees freedom (DF) in numerator and 335 DF in denominator.||null hypothesis of no mean ALC changes over time in any treatment group. Conditional F-tests were used to test for mean ALC changes over time in each treatment arm and the difference between treatment arms in the pattern of change in ALC over time.||||0.027
91612957|NCT00858702|183120090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No consideration for multiplicity|Fisher Exact|||||||<0.001
91612958|NCT00367640|183120104|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0006
91612959|NCT00367640|183120104|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0001
91612960|NCT00367640|183120104|SUPERIORITY_OR_OTHER|||||||0.4606|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.4606
91612961|NCT02417233|183120105|OTHER||Odds Ratio (OR)|0.958||||0.848|TWO_SIDED|95.0|0.62|1.49|||Regression, Logistic|||||1.49|0.62|0.848
91612962|NCT02417233|183120105|OTHER||Odds Ratio (OR)|1.492||||0.125|TWO_SIDED|95.0|0.9|2.49|||Regression, Logistic|||||2.49|0.90|0.125
91612963|NCT02417233|183120106|OTHER||Odds Ratio (OR)|0.866||||0.636|TWO_SIDED|96.0|0.48|1.57|||Regression, Logistic|||||1.57|0.48|0.636
91612964|NCT02417233|183120106|OTHER||Odds Ratio (OR)|1.401||||0.165|TWO_SIDED|95.0|0.87|2.26|||Regression, Logistic|||||2.26|0.87|0.165
91612965|NCT02417233|183120107|OTHER||Odds Ratio (OR)|1.48||||0.16|TWO_SIDED|95.0|0.86|2.55|||Regression, Logistic|||||2.55|0.86|0.16
91612966|NCT02417233|183120107|OTHER||Odds Ratio (OR)|1.82||||0.03|TWO_SIDED|95.0|1.06|3.14|||Regression, Logistic|||||3.14|1.06|0.03
91612967|NCT02417233|183120108|OTHER||Odds Ratio (OR)|0.27||||0.24|TWO_SIDED|95.0|0.03|2.45|||Regression, Logistic|||||2.45|0.03|0.24
91612968|NCT02417233|183120108|OTHER||Odds Ratio (OR)|2.68||||0.2|TWO_SIDED|95.0|0.59|12.16|||Regression, Logistic|||||12.16|0.59|0.20
91612969|NCT02417233|183120109|OTHER||Odds Ratio (OR)|1.943||||0.093|TWO_SIDED|95.0|0.9|4.21|||Regression, Logistic|||||4.21|0.90|0.093
91612970|NCT02417233|183120109|OTHER||Odds Ratio (OR)|1.764||||0.152|TWO_SIDED|95.0|0.81|3.83|||Regression, Logistic|||||3.83|0.81|0.152
91612971|NCT03408873|183120136|OTHER||Mean Difference (Final Values)|-31.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91612972|NCT03408873|183120136|OTHER||Mean Difference (Final Values)|-11.7||||0.12|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.12
91612973|NCT03408873|183120137|OTHER||Mean Difference (Final Values)|-19.6||||0.0599|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.0599
91789883|NCT00796991|183459073|SUPERIORITY_OR_OTHER|||||||0.5||||||P-values were not corrected for multiple testing. F Statistic =0.94|Omnibus conditional F-test|10 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in all treatment groups. Test of overall time-by-treatment interaction used an omnibus conditional F-test.||||0.5
91524116|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|3.53||||0.602|TWO_SIDED|95.0|-9.85|16.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.91|-9.85|0.602
91789884|NCT00796991|183459073|SUPERIORITY_OR_OTHER|||||||0.37||||||P-values were not corrected for multiple testing. F Statistic =1.08|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.37
91789885|NCT00796991|183459073|SUPERIORITY_OR_OTHER|||||||0.85||||||P-values were not corrected for multiple testing. F Statistic =0.39|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.85
91789886|NCT00796991|183459073|SUPERIORITY_OR_OTHER|||||||0.22||||||P-values were not corrected for multiple testing. F Statistic = 1.41|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.22
91789887|NCT02199717|183459094|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.||||0.32
91789888|NCT02199717|183459095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|306.4|||<|0.01|TWO_SIDED|95.0|254.8|358.0|||Wilcoxon (Mann-Whitney)|||||358|254.8|<0.01
91789889|NCT04355728|183459138|SUPERIORITY|||||||0.04|||||||Fisher Exact|||"The null hypothesis is the following: There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group."||||.04
91789890|NCT04355728|183459147|SUPERIORITY||Hazard Ratio (HR)|0.289||||0.0307|TWO_SIDED|95.0|0.088|0.948|||Log Rank||Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.|"The null hypothesis is the following: There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group. Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups."||0.948|0.088|0.0307
91789891|NCT04355728|183459148|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
91789892|NCT04355728|183459149|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
91789893|NCT04355728|183459180|SUPERIORITY|||||||0.0356|||||||Wilcoxon (Mann-Whitney)|||||||0.0356
91789894|NCT04355728|183459181|SUPERIORITY|||||||0.0215|||||||Wilcoxon (Mann-Whitney)|||||||0.0215
91789895|NCT04355728|183459182|SUPERIORITY||Mean Difference (Net)|-3498.0|STANDARD_DEVIATION|3078.2||0.021|TWO_SIDED|95.0|-6404.7|-591.2|||t-test, 2 sided|||||-591.2|-6404.7|0.0210
91612974|NCT03408873|183120137|OTHER||Mean Difference (Final Values)|-3.2||||0.63|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.63
91789896|NCT04355728|183459184|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 3 days post first infusion."||||0.48
91789897|NCT04355728|183459184|SUPERIORITY|||||||0.41|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 3 days post first infusion."||||0.41
91789898|NCT04355728|183459185|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 6 days post first infusion."||||1.00
91789899|NCT04355728|183459185|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (Class II) status and treatment group at 6 days post first infusion."||||1.00
91789900|NCT04355728|183459186|SUPERIORITY|||||||0.44|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 14 days post first infusion."||||0.44
91789901|NCT04355728|183459186|SUPERIORITY|||||||0.5238|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 14 days post first infusion."||||0.5238
91789902|NCT00608569|183459203|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Results were considered to be statistically significant if p\<0.05|Fisher Exact|||Fisher exact test (unstratified)||||0.133
91789903|NCT03011892|183459211|SUPERIORITY||Difference in Least Square (LS) Mean|-59.66|||<|0.0001|TWO_SIDED|95.0|-77.85|-41.47|||MMRM|||||-41.47|-77.85|< 0.0001
91789904|NCT03011892|183459212|SUPERIORITY||Difference in LS Mean|-33.01||||0.0004|TWO_SIDED|95.0|-51.27|-14.76|||MMRM|||DB: Vehicle BID, Ruxolitinib 0.15% QD||-14.76|-51.27|0.0004
91789905|NCT03011892|183459212|SUPERIORITY||Difference in LS Mean|-40.9|||<|0.0001|TWO_SIDED|95.0|-59.23|-22.57|||MMRM|||||-22.57|-59.23|< 0.0001
91789906|NCT03011892|183459212|SUPERIORITY||Difference in LS Mean|-54.82|||<|0.0001|TWO_SIDED|95.0|-72.93|-36.7|||MMRM|||||-36.70|-72.93|< 0.0001
91789907|NCT03011892|183459213|SUPERIORITY||Difference in LS Mean|14.63||||0.1127|TWO_SIDED|95.0|-3.47|32.73|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD||32.73|-3.47|0.1127
91789908|NCT03011892|183459213|SUPERIORITY||Difference in LS Mean|6.74||||0.4659|TWO_SIDED|95.0|-11.44|24.92|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD||24.92|-11.44|0.4659
91789909|NCT03011892|183459213|SUPERIORITY||Difference in LS Mean|-7.18||||0.432|TWO_SIDED|95.0|-25.13|10.77|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD||10.77|-25.13|0.4320
91789910|NCT03011892|183459213|SUPERIORITY||Difference in LS Mean|-12.02||||0.1903|TWO_SIDED|95.0|-30.05|6.0|||MMRM|||||6.00|-30.05|0.1903
91789911|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-25.12||||0.0009|TWO_SIDED|95.0|-39.84|-10.41|||MMRM|||Week 2||-10.41|-39.84|0.0009
91789912|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-47.85|||<|0.0001|TWO_SIDED|95.0|-62.64|-33.06|||MMRM|||Week 2||-33.06|-62.64|< 0.0001
91789913|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-41.04|||<|0.0001|TWO_SIDED|95.0|-56.0|-26.08|||MMRM|||Week 2||-26.08|-56.00|< 0.0001
91789914|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-45.05|||<|0.0001|TWO_SIDED|95.0|-59.69|-30.4|||MMRM|||Week 2||-30.40|-59.69|< 0.0001
91789915|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|9.99||||0.1806|TWO_SIDED|95.0|-4.66|24.63|||MMRM|||Week 2||24.63|-4.66|0.1806
91789916|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-5.93||||0.4333|TWO_SIDED|95.0|-20.82|8.95|||MMRM|||Week 2||8.95|-20.82|0.4333
91789917|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-9.94||||0.1805|TWO_SIDED|95.0|-24.51|4.63|||MMRM|||Week 2||4.63|-24.51|0.1805
91789918|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-12.74||||0.0895|TWO_SIDED|95.0|-27.45|1.98|||MMRM|||Week 2||1.98|-27.45|0.0895
91789919|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-28.38||||0.0042|TWO_SIDED|95.0|-47.74|-9.02|||MMRM|||Week 8||-9.02|-47.74|0.0042
91789920|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-36.52||||0.0003|TWO_SIDED|95.0|-56.03|-17.01|||MMRM|||Week 8||-17.01|-56.03|0.0003
91789921|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-45.19|||<|0.0001|TWO_SIDED|95.0|||||MMRM|||Week 8||||< 0.0001
91789922|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-57.15|||<|0.0001|TWO_SIDED|95.0|-76.53|-37.77|||MMRM|||Week 8||-37.77|-76.53|< 0.0001
91789923|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|7.78||||0.4243|TWO_SIDED|95.0|-11.37|26.93|||MMRM|||Week 8||26.93|-11.37|0.4243
91789924|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-0.35||||0.9715|TWO_SIDED|95.0|-19.65|18.95|||MMRM|||Week 8||18.95|-19.65|0.9715
91789925|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-9.03||||0.3507|TWO_SIDED|95.0|-28.05|9.99|||MMRM|||Week 8||9.99|-28.05|0.3507
91789926|NCT03011892|183459214|SUPERIORITY||Difference in LS Mean|-20.98||||0.032|TWO_SIDED|95.0|-40.15|-1.82|||MMRM|||Week 8||-1.82|-40.15|0.0320
91789927|NCT03381729|183459233|SUPERIORITY||Difference in Percent|-6.0|||>|0.9999|TWO_SIDED|95.0|-21.8|22.8|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to stand alone.|Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 7 (13.7%) participants achieved the ability to stand alone and 44 (86.3%) participants did not achieve the ability to stand alone.|22.8|-21.8|>0.9999
91789928|NCT03381729|183459234|SUPERIORITY||Difference Between Least Squares Mean|5.5||||0.0027|TWO_SIDED|95.0|1.9|9.0|||Mixed-Model Repeat Measure||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where the least squares mean (95% confidence interval) of the change from baseline in HFMSE scores at 12 months was 0.5 (-2.2 to 3.2).|9.0|1.9|0.0027
91612975|NCT03408873|183120139|OTHER||Mean Difference (Final Values)|-10.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91612976|NCT03408873|183120140|OTHER||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91789929|NCT03381729|183459236|SUPERIORITY||Percentage Difference|-2.1|||>|0.9999|TWO_SIDED|95.0|-17.2|27.0|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to walk alone.|Data for the current study were compared to historical control data (Finkel et al 2014 PubMed 25080519) where 5 (9.8%) participants achieved the ability to walk alone and 46 (90.2%) participants did not achieve the ability to walk alone.|27.0|-17.2|>0.9999
91789930|NCT04456153|183459238|SUPERIORITY|||||||0.17|||||||GLMM|||||||0.170
91789931|NCT04456153|183459239|SUPERIORITY|||||||0.051|||||||GLMM|||||||0.051
91789932|NCT04456153|183459242|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
91789933|NCT04456153|183459243|SUPERIORITY|||||||0.76|||||||trapezoidal method|||||||0.76
91789934|NCT03758755|183459245|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.0219|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in IKDC score at 12 weeks post-op.||||0.0219
91789935|NCT03758755|183459246|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.008|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in VAS score at 12 weeks post-op.||||0.008
91789936|NCT03758755|183459247|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.011|||||||t-test, 1 sided|||This analysis compares the change over time in quadriceps tendon strength between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in quadriceps tendon strength over time.||||0.011
91789937|NCT03758755|183459248|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.223|||||||t-test, 1 sided|||This analysis compares the change over time in thigh circumference between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in thigh circumference over time.||||0.223
91612977|NCT03408873|183120140|OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||<0.001
91789938|NCT03758755|183459249|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.242|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee flexion between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee flexion over time.||||0.242
91524117|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|22.72||||0.001|TWO_SIDED|95.0|12.39|33.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.05|12.39|0.001
91524118|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|60.37|||<|0.001|TWO_SIDED|95.0|48.61|72.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.12|48.61|<0.001
91612978|NCT03408873|183120141|OTHER||Mean Difference (Final Values)|-16.6|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91789939|NCT03758755|183459250|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.049|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee extension between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee extension over time.||||0.049
91789940|NCT02312687|183459268|SUPERIORITY||Least Squares (LS) Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.48|0.88||The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|generalized estimation equation (GEE)|||Change at Week 24||0.88|0.48|< 0.0001
91789941|NCT02312687|183459268|SUPERIORITY||LS Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.79||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||0.79|0.57|< 0.0001
91789942|NCT02312687|183459268|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.75||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||0.75|0.44|< 0.0001
91789943|NCT02312687|183459268|SUPERIORITY||LS Mean|0.47|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||0.63|0.31|< 0.0001
91789944|NCT02312687|183459268|SUPERIORITY||LS Mean|0.57|||<|0.0001|TWO_SIDED|95.0|0.41|0.73||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||0.73|0.41|< 0.0001
91789945|NCT02312687|183459268|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.43|0.76||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||0.76|0.43|< 0.0001
91789946|NCT02312687|183459269|SUPERIORITY||LS Mean|-9.75||||0.1366|TWO_SIDED|95.0|-22.59|3.09||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 24||3.09|-22.59|0.1366
91789947|NCT02312687|183459269|SUPERIORITY||LS Mean|-11.17||||0.1334|TWO_SIDED|95.0|-25.76|3.42||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 48||3.42|-25.76|0.1334
91789948|NCT02312687|183459269|SUPERIORITY||LS Mean|-18.12|||<|0.0001|TWO_SIDED|95.0|-27.07|-9.17||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 72||-9.17|-27.07|< 0.0001
91789949|NCT02312687|183459269|SUPERIORITY||LS Mean|-25.28|||<|0.0001|TWO_SIDED|95.0|-36.21|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 96||-14.35|-36.21|< 0.0001
91789950|NCT02312687|183459269|SUPERIORITY||LS Mean|-22.39|||<|0.0001|TWO_SIDED|95.0|-31.51|-13.26||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 120||-13.26|-31.51|< 0.0001
91789951|NCT02312687|183459269|SUPERIORITY||LS Mean|-28.33|||<|0.0001|TWO_SIDED|95.0|-40.11|-16.56||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 144||-16.56|-40.11|< 0.0001
91612979|NCT03408873|183120141|OTHER|We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24) to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.|Mean Difference (Final Values)|-8.1||||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.003
91612980|NCT03408873|183120142|OTHER|We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data.|Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91612981|NCT03408873|183120142|OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
91612982|NCT03408873|183120143|OTHER||Mean Difference (Final Values)|0.8||||0.0566|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.0566
91789952|NCT02312687|183459270|SUPERIORITY||LS Mean|215493.38|||<|0.0001|TWO_SIDED|95.0|194650.78|236335.97||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||236335.97|194650.78|< 0.0001
91789953|NCT02312687|183459270|SUPERIORITY||LS Mean|202525.38|||<|0.0001|TWO_SIDED|95.0|168364.92|236685.83||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||236685.83|168364.92|< 0.0001
91789954|NCT02312687|183459270|SUPERIORITY||LS Mean|221481.03|||<|0.0001|TWO_SIDED|95.0|179628.07|263333.98||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||263333.98|179628.07|< 0.0001
91789955|NCT02312687|183459270|SUPERIORITY||LS Mean|221674.07|||<|0.0001|TWO_SIDED|95.0|181313.34|262034.81||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||262034.81|181313.34|< 0.0001
91789956|NCT02312687|183459270|SUPERIORITY||LS Mean|208270.02|||<|0.0001|TWO_SIDED|95.0|167217.98|249322.06||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||249322.06|167217.98|< 0.0001
91789957|NCT02312687|183459270|SUPERIORITY||LS Mean|235953.55|||<|0.0001|TWO_SIDED|95.0|166110.59|305796.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||305796.52|166110.59|< 0.0001
91789958|NCT02312687|183459271|SUPERIORITY||LS Mean|1277.84|||<|0.0001|TWO_SIDED|95.0|1202.34|1353.34||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||1353.34|1202.34|< 0.0001
91789959|NCT02312687|183459271|SUPERIORITY||LS Mean|1244.99|||<|0.0001|TWO_SIDED|95.0|1166.1|1323.88||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1323.88|1166.10|< 0.0001
91612983|NCT03408873|183120144|OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between screen and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
91612984|NCT03408873|183120145|OTHER||Mean Difference (Final Values)|17.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91789960|NCT02312687|183459271|SUPERIORITY||LS Mean|1298.49|||<|0.0001|TWO_SIDED|95.0|1233.56|1363.43||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||1363.43|1233.56|< 0.0001
91789961|NCT02312687|183459271|SUPERIORITY||LS Mean|1311.05|||<|0.0001|TWO_SIDED|95.0|1238.3|1383.8||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||1383.80|1238.30|< 0.0001
91789962|NCT02312687|183459271|SUPERIORITY||LS Mean|1368.68|||<|0.0001|TWO_SIDED|95.0|1327.4|1409.96||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||1409.96|1327.40|< 0.0001
91789963|NCT02312687|183459271|SUPERIORITY||LS Mean|1298.41|||<|0.0001|TWO_SIDED|95.0|1208.31|1388.51||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||1388.51|1208.31|< 0.0001
91612985|NCT03408873|183120146|OTHER||Mean Difference (Final Values)|16.9|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91612986|NCT03408873|183120147|OTHER||Mean Difference (Final Values)|14.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91524119|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|2.25||||0.761|TWO_SIDED|95.0|-12.1|16.59||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.59|-12.10|0.761
91524120|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|58.32|||<|0.001|TWO_SIDED|95.0|46.59|70.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||70.05|46.59|<0.001
91524121|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|67.52|||<|0.001|TWO_SIDED|95.0|54.91|80.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.12|54.91|<0.001
91524122|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.42||||0.41|TWO_SIDED|95.0|-7.34|18.18||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.18|-7.34|0.410
91524123|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|62.13|||<|0.001|TWO_SIDED|95.0|48.96|75.29||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.29|48.96|<0.001
91612987|NCT03408873|183120148|OTHER||Mean Difference (Final Values)|19.2|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
91612988|NCT03408873|183120149|OTHER||Mean Difference (Final Values)|-0.5||||0.73|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.73
91612989|NCT03408873|183120150|OTHER||Mean Difference (Final Values)|-10.7||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.02
91612990|NCT00062738|183120152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.05|TWO_SIDED|95.0|0.8|15.9|||Fisher Exact|||For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.||15.9|0.8|<.05
91612991|NCT01600131|183120153|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|1.72||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.693
91612992|NCT01600131|183120154|SUPERIORITY||Slope|-2.17|STANDARD_ERROR_OF_MEAN|2.07||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group x time interaction|||||0.693
91524124|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|68.64|||<|0.001|TWO_SIDED|95.0|56.11|81.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.16|56.11|<0.001
91612993|NCT01600131|183120155|SUPERIORITY||Slope|-2.08|STANDARD_ERROR_OF_MEAN|1.08||0.055|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.055
91612994|NCT01600131|183120156|SUPERIORITY||Slope|-1.08|STANDARD_ERROR_OF_MEAN|1.15||0.346|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.346
91612995|NCT01600131|183120158|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.79||0.688|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.688
91612996|NCT01600131|183120159|SUPERIORITY||Slope|-1.52|STANDARD_ERROR_OF_MEAN|1.87||0.418|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.418
91612997|NCT01600131|183120160|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.45||0.18|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.180
91612998|NCT01600131|183120161|SUPERIORITY||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.65||0.332|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.332
91524125|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91612999|NCT01600131|183120162|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.56||0.318|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.318
91613000|NCT01600131|183120163|SUPERIORITY||Slope|2.33|STANDARD_ERROR_OF_MEAN|1.31||0.077|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.077
91613001|NCT01600131|183120164|SUPERIORITY||Slope|1.5|STANDARD_ERROR_OF_MEAN|1.46||0.305|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.305
91613002|NCT01600131|183120167|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.94||0.514|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.514
91613003|NCT01600131|183120168|SUPERIORITY||Slope|-1.61|STANDARD_ERROR_OF_MEAN|0.94||0.09|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.090
91613004|NCT01600131|183120169|SUPERIORITY||Slope|6.71|STANDARD_ERROR_OF_MEAN|2.57||0.009|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.009
91654886|NCT03552757|183202510|SUPERIORITY||Treatment difference|-6.21|||<|0.0001|TWO_SIDED|95.0|-7.28|-5.15|||ANCOVA|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||-5.15|-7.28|<0.0001
91789964|NCT02312687|183459272|SUPERIORITY||LS Mean|7.87||||0.0011|TWO_SIDED|95.0|3.16|12.58||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||12.58|3.16|0.0011
91524126|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|63.34|||<|0.001|TWO_SIDED|95.0|50.32|76.35||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.35|50.32|<0.001
91613005|NCT01600131|183120170|SUPERIORITY||Slope|4.29|STANDARD_ERROR_OF_MEAN|3.53||0.225|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.225
91613006|NCT01600131|183120171|SUPERIORITY||Slope|3.75|STANDARD_ERROR_OF_MEAN|4.89||0.443|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.443
91613007|NCT01600131|183120172|SUPERIORITY||Slope|7.39|STANDARD_ERROR_OF_MEAN|5.23||0.158|TWO_SIDED||||||Mixed Models Analysis||group x time interaction|||||0.158
91613008|NCT01600131|183120173|SUPERIORITY||Slope|7.28|STANDARD_ERROR_OF_MEAN|3.64||0.046|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.046
91613009|NCT01600131|183120174|SUPERIORITY||Slope|5.54|STANDARD_ERROR_OF_MEAN|3.83||0.149|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.149
91613010|NCT01600131|183120175|SUPERIORITY||Slope|4.16|STANDARD_ERROR_OF_MEAN|1.95||0.034|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.034
91613011|NCT01600131|183120176|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|1.52||0.846|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.846
91613012|NCT01600131|183120177|SUPERIORITY||Slope|1.67|STANDARD_ERROR_OF_MEAN|2.17||0.0442|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||.0442
91613013|NCT01600131|183120178|SUPERIORITY||Slope|1.98|STANDARD_ERROR_OF_MEAN|1.88||0.293|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.293
91613014|NCT00700752|183120196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1636|STANDARD_ERROR_OF_MEAN|0.1887|||TWO_SIDED|95.0|0.789|1.1636|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus balafilcon A.|Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.||1.1636|0.7890|
91613015|NCT03303339|183120218|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||||||
91613016|NCT00510692|183120233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.005|TWO_SIDED|95.0|-1.78|-0.35|||ANCOVA|||||-0.35|-1.78|0.005
91613017|NCT02116972|183120238|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.0821|TWO_SIDED|95.0|-1.22|0.07|||Logitudinal mixed effects model|||The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.||0.07|-1.22|0.0821
91654887|NCT03552757|183202510|SUPERIORITY||Treatment difference|-7.57|||<|0.0001|TWO_SIDED|95.0|-8.56|-6.58|||MMRM|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||-6.58|-8.56|<0.0001
91789965|NCT02312687|183459272|SUPERIORITY||LS Mean|2.7||||0.3092|TWO_SIDED|95.0|-2.5|7.9||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||7.90|-2.50|0.3092
91789966|NCT02312687|183459272|SUPERIORITY||LS Mean|2.62||||0.2958|TWO_SIDED|95.0|-2.29|7.53||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||7.53|-2.29|0.2958
91789967|NCT02312687|183459272|SUPERIORITY||LS Mean|0.31||||0.8796|TWO_SIDED|95.0|-3.71|4.33||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||4.33|-3.71|0.8796
91789968|NCT02312687|183459272|SUPERIORITY||LS Mean|-0.48||||0.8396|TWO_SIDED|95.0|-5.11|4.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||4.16|-5.11|0.8396
91710546|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.27|||t-test, 2 sided|||FEV1 Day 8 (-0.75 hrs post-dose)||0.27|0.16|<0.0001
91789969|NCT02312687|183459272|SUPERIORITY||LS Mean|-3.43||||0.2284|TWO_SIDED|95.0|-9.0|2.15||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||2.15|-9.00|0.2284
91789970|NCT02312687|183459273|SUPERIORITY||LS Mean|0.57|||||TWO_SIDED|95.0|0.32|0.83||||||Change at Week 24||0.83|0.32|
91789971|NCT02312687|183459273|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.37|0.56||||||Change at Week 48||0.56|0.37|
91613018|NCT00784784|183120252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.25|TWO_SIDED|95.0|0.01|4.8|||Fisher Exact|||That in a year with mismatch between influenza vaccine antigen and infecting H3N2 strain, seasonal (10-13 weeks) antiviral prophylaxis in adults will provide better protection from symptomatic influenza infection than trivalent inactivated split virus influenza vaccine.||4.8|0.01|0.25
91613019|NCT00872898|183120254|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.2||||0.1197|TWO_SIDED|95.0|-4.9|0.6|||mixed-model for repeated measures|||||0.6|-4.9|0.1197
91613020|NCT00872898|183120255|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9781|TWO_SIDED|95.0|-7.2|7.0|||mixed-model for repeated measures|||||7.0|-7.2|0.9781
91613021|NCT00872898|183120256|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4||||0.1459|TWO_SIDED|95.0|-3.2|0.5|||mixed-model for repeated measures|||||0.5|-3.2|0.1459
91613022|NCT00872898|183120257|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8||||0.1344|TWO_SIDED|95.0|-1.9|0.3|||mixed-model for repeated measures|||||0.3|-1.9|0.1344
91613023|NCT00872898|183120258|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.7|TWO_SIDED|95.0|-1.5|1.0|||mixed-model for repeated measures|||||1.0|-1.5|0.7000
91613024|NCT00872898|183120259|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9069|TWO_SIDED|95.0|-1.3|1.1|||mixed-model for repeated measures|||||1.1|-1.3|0.9069
91613025|NCT00872898|183120260|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.3||||0.4679|TWO_SIDED|95.0|-1.2|0.6|||mixed-model for repeated measures|||||0.6|-1.2|0.4679
91613026|NCT00872898|183120261|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9598|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9598
91613027|NCT00872898|183120262|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9898|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9898
91613028|NCT00872898|183120263|SUPERIORITY_OR_OTHER||Least squares mean difference|0.5||||0.4228|TWO_SIDED|95.0|-0.7|1.6|||mixed-model for repeated measures|||||1.6|-0.7|0.4228
91613029|NCT00872898|183120264|SUPERIORITY_OR_OTHER||Least squares mean difference|1.4||||0.0201|TWO_SIDED|95.0|0.2|2.5|||mixed-model for repeated measures|||||2.5|0.2|0.0201
91613030|NCT00872898|183120265|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.9|||mixed-model for repeated measures|||||0.9|-1.3|0.6889
91613031|NCT00872898|183120266|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.7481|TWO_SIDED|95.0|-0.9|1.2|||mixed-model for repeated measures|||||1.2|-0.9|0.7481
91613032|NCT00872898|183120267|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.95|TWO_SIDED|95.0|-1.2|1.1|||mixed-model for repeated measures|||||1.1|-1.2|0.9500
91613033|NCT02428140|183120268|SUPERIORITY||Risk Ratio (RR)|3.29||||0.003|TWO_SIDED|95.0|1.45|7.42|||t-test, 2 sided|||||7.42|1.45|0.003
91613034|NCT02428140|183120269|SUPERIORITY||Risk Difference (RD)|10.7||||0.005|TWO_SIDED|95.0|3.4|17.9|||t-test, 2 sided|||||17.9|3.4|.005
91613035|NCT02428140|183120270|SUPERIORITY||Risk Difference (RD)|2.7||||0.28|TWO_SIDED|95.0|-1.0|6.3|||t-test, 2 sided|||||6.3|-1.0|0.28
91613036|NCT02428140|183120272|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
91613037|NCT02428140|183120273|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-3.2|3.2||||||||3.2|-3.2|
91613038|NCT02989727|183120282|SUPERIORITY||ANOVA estimate|1.88|STANDARD_ERROR_OF_MEAN|3.51||0.59|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.59
91710547|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.28|||t-test, 2 sided|||FEV1 Day 8 (-0.25 hrs post-dose)||0.28|0.16|<0.0001
91789972|NCT02312687|183459273|SUPERIORITY||LS Mean|0.42|||||TWO_SIDED|95.0|0.28|0.56||||||Change at Week 72||0.56|0.28|
91613039|NCT02989727|183120283|SUPERIORITY||ANOVA estimate|0.5|STANDARD_ERROR_OF_MEAN|2.56||0.84|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.84
91613040|NCT02989727|183120284|SUPERIORITY||Cox Proportional Hazard|1.2|STANDARD_ERROR_OF_MEAN|0.1||0.08|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.08
91613041|NCT02989727|183120284|SUPERIORITY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.12||0.53|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.53
91789973|NCT02312687|183459273|SUPERIORITY||LS Mean|0.44|||||TWO_SIDED|95.0|0.27|0.6||||||Change at Week 96||0.60|0.27|
91789974|NCT02312687|183459273|SUPERIORITY||LS Mean|0.36|||||TWO_SIDED|95.0|0.23|0.48||||||Change at Week 120||0.48|0.23|
91789975|NCT02312687|183459273|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.32|0.62||||||Change at Week 144||0.62|0.32|
91789976|NCT02312687|183459274|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|95.0|0.01|0.07||||||Change at Week 24||0.07|0.01|
91789977|NCT02312687|183459274|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 48||0.03|-0.01|
91789978|NCT02312687|183459274|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 72||0.04|-0.01|
91789979|NCT02312687|183459274|SUPERIORITY||LS Mean|0.05|||||TWO_SIDED|95.0|0.02|0.07||||||Change at Week 96||0.07|0.02|
91524127|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91524128|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91524129|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91524130|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91524131|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91524132|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91524133|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91524134|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91613042|NCT02989727|183120292|SUPERIORITY||Cox Proportional Hazard|1.27|STANDARD_ERROR_OF_MEAN|0.11||0.02|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.02
91789980|NCT02312687|183459274|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
91613043|NCT02989727|183120292|SUPERIORITY||Cox Proportional Hazard|1.05|STANDARD_ERROR_OF_MEAN|0.13||0.73|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.73
91613044|NCT01614769|183120326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|||||TWO_SIDED|90.0|-22.98|51.8||||||||51.80|-22.98|
91613045|NCT01614769|183120326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.33|||||TWO_SIDED|90.0|-2.08|72.74||||||||72.74|-2.08|
91613046|NCT01614769|183120327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.21|0.0||||||||0.00|-0.21|
91613047|NCT01614769|183120327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.24|-0.03||||||||-0.03|-0.24|
91789981|NCT02312687|183459274|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05||||||Change at Week 144||0.05|-0.01|
91789982|NCT02312687|183459275|SUPERIORITY||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 24||-0.01|-0.07|
91789983|NCT02312687|183459275|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.01||||||Change at Week 48||0.01|-0.03|
91789984|NCT02312687|183459275|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.01||||||Change at Week 72||0.01|-0.04|
91789985|NCT02312687|183459275|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.07|-0.02||||||Change at Week 96||-0.02|-0.07|
91789986|NCT02312687|183459275|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.02||||||Change at Week 120||0.02|-0.03|
91789987|NCT02312687|183459275|SUPERIORITY||LS Mean|-0.02|||||TWO_SIDED|95.0|-0.05|0.01||||||Change at Week 144||0.01|-0.05|
91789988|NCT02312687|183459276|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.1|0.08||||||Change at Week 24||0.08|-0.10|
91789989|NCT02312687|183459276|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.07|0.1||||||Change at Week 48||0.10|-0.07|
91789990|NCT02312687|183459276|SUPERIORITY||LS Mean|0.08|||||TWO_SIDED|95.0|-0.01|0.16||||||Change at Week 72||0.16|-0.01|
91789991|NCT02312687|183459276|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.09|0.06||||||Change at Week 96||0.06|-0.09|
91789992|NCT02312687|183459276|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.1||||||Change at Week 120||0.10|-0.12|
91789993|NCT02312687|183459276|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.16|0.06||||||Change at Week 144||0.06|-0.16|
91789994|NCT02312687|183459277|SUPERIORITY||LS Mean|22.89|||||TWO_SIDED|95.0|-1.81|47.6||||||Change at Week 24||47.60|-1.81|
91789995|NCT02312687|183459277|SUPERIORITY||LS Mean|15.15|||||TWO_SIDED|95.0|-2.32|32.62||||||Change at Week 48||32.62|-2.32|
91789996|NCT02312687|183459277|SUPERIORITY||LS Mean|11.1|||||TWO_SIDED|95.0|-14.33|36.53||||||Change at Week 72||36.53|-14.33|
91524135|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91524136|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91524137|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91524138|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91524139|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
91524140|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
91524141|NCT01216163|182923475|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
91613048|NCT01614769|183120328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03|||||TWO_SIDED|90.0|-11.12|1.05||||||||1.05|-11.12|
91613049|NCT01614769|183120328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||||TWO_SIDED|90.0|-13.3|-1.24||||||||-1.24|-13.30|
91613050|NCT04011436|183120329|SUPERIORITY|In the bivariate analysis, a comparison was initially made of each of the domains of the Kujala test, for the assessment of pain at baseline, assessing the differences between the intervention groups using the chi-square or Fisher's exact tests. The Spearman correlation coefficient was used to evaluate the relationship between two continuous variables, such as Q angle and anterior knee pain, assessing the correlation marginally and conditionally on each of the treatment groups.|difference in frequency distribution|0.05|||<|0.05|TWO_SIDED|95.0|0.025|0.05|||Fisher Exact|we also used Chi-squared for the domains of pain and limp.||||0.05|0.025|<0.05
91613051|NCT04011436|183120330|SUPERIORITY|For the analysis of the differences in medians between the groups, taking into account that the outcomes did not present a normal distribution, and assuming the assumption of independence of the variables, the non-parametric Mann-Whitney U test was used.|Median Difference (Final Values)|0.058|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was done for the assessment of change in pain with Visual Analogue Scale.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
91789997|NCT02312687|183459277|SUPERIORITY||LS Mean|-16.65|||||TWO_SIDED|95.0|-37.5|4.2||||||Change at Week 96||4.20|-37.50|
91789998|NCT02312687|183459277|SUPERIORITY||LS Mean|3.48|||||TWO_SIDED|95.0|-32.53|39.49||||||Change at Week 120||39.49|-32.53|
91789999|NCT02312687|183459277|SUPERIORITY||LS Mean|28.55|||||TWO_SIDED|95.0|-11.12|68.22||||||Change at Week 144||68.22|-11.12|
91790000|NCT02312687|183459278|SUPERIORITY||LS Mean|-14.77|||||TWO_SIDED|95.0|-87.62|58.08||||||Change at Week 24||58.08|-87.62|
91790001|NCT02312687|183459278|SUPERIORITY||LS Mean|-70.79|||||TWO_SIDED|95.0|-161.31|19.74||||||Change at Week 48||19.74|-161.31|
91790002|NCT02312687|183459278|SUPERIORITY||LS Mean|-16.11|||||TWO_SIDED|95.0|-110.96|78.73||||||Change at Week 72||78.73|-110.96|
91790003|NCT02312687|183459278|SUPERIORITY||LS Mean|-41.74|||||TWO_SIDED|95.0|-150.61|67.13||||||Change at Week 96||67.13|-150.61|
91790004|NCT02312687|183459278|SUPERIORITY||LS Mean|-76.11|||||TWO_SIDED|95.0|-237.29|85.08||||||Change at Week 120||85.08|-237.29|
91790005|NCT02312687|183459278|SUPERIORITY||LS Mean|-96.06|||||TWO_SIDED|95.0|-206.59|14.46||||||Change at Week 144||14.46|-206.59|
91790006|NCT02312687|183459279|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 24||0.03|-0.01|
91790007|NCT02312687|183459279|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 48||0.04|-0.01|
91790008|NCT02312687|183459279|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.02||||||Change at Week 72||0.02|-0.02|
91790009|NCT02312687|183459279|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||Change at Week 96||0.02|-0.04|
91790010|NCT02312687|183459279|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
91790011|NCT02312687|183459279|SUPERIORITY||LS Mean|0.03|||||TWO_SIDED|95.0|-0.01|0.08||||||Change at Week 144||0.08|-0.01|
91790012|NCT02312687|183459280|SUPERIORITY||LS Mean|14.92||||0.0314|TWO_SIDED|95.0|1.33|28.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||28.52|1.33|0.0314
91524142|NCT01216163|182923476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
91524143|NCT01216163|182923476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.303|TWO_SIDED|95.0|0.45|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.28|0.45|0.303
91524144|NCT01216163|182923476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.28|0.10|<0.001
91524145|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-40.1|||<|0.001|TWO_SIDED|95.0|-55.39|-24.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.80|-55.39|<0.001
91524146|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-0.12||||0.958|TWO_SIDED|95.0|-4.52|4.28||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.28|-4.52|0.958
91524147|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-40.19|||<|0.001|TWO_SIDED|95.0|-55.51|-24.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.87|-55.51|<0.001
91524148|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-63.4|||<|0.001|TWO_SIDED|95.0|-77.81|-48.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.99|-77.81|<0.001
91524149|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-7.17||||0.108|TWO_SIDED|95.0|-15.91|1.57||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.57|-15.91|0.108
91524150|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-56.39|||<|0.001|TWO_SIDED|95.0|-71.68|-41.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-41.09|-71.68|<0.001
91524151|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-71.01|||<|0.001|TWO_SIDED|95.0|-84.09|-57.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.93|-84.09|<0.001
91524152|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-9.82||||0.083|TWO_SIDED|95.0|-20.18|1.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.16|-20.18|0.083
91524153|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-61.14|||<|0.001|TWO_SIDED|95.0|-75.4|-46.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.87|-75.40|<0.001
91524154|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-66.37|||<|0.001|TWO_SIDED|95.0|-80.08|-52.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-52.66|-80.08|<0.001
91613052|NCT04011436|183120331|SUPERIORITY||Median Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for Change in Patellofemoral Misalignment With Q Angle´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
91613053|NCT04011436|183120332|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was calculated for the change in core strength with McGill´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
91613054|NCT04011436|183120333|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for the change in Quadriceps and Gluteus Strength With Squat´s Test.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
91613055|NCT04011436|183120334|SUPERIORITY||Median Difference (Final Values)|0.55|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in Static Balance with Single Leg Stance.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
91613056|NCT04011436|183120335|SUPERIORITY||Median Difference (Final Values)|0.492|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in the total amount of Physical Activity reported in minutes.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
91790013|NCT02312687|183459280|SUPERIORITY||LS Mean|-1.73||||0.764|TWO_SIDED|95.0|-13.0|9.55||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||9.55|-13.00|0.7640
91790014|NCT02312687|183459280|SUPERIORITY||LS Mean|-22.28|||<|0.0001|TWO_SIDED|95.0|-30.2|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-14.35|-30.20|< 0.0001
91790015|NCT02312687|183459280|SUPERIORITY||LS Mean|-20.93|||<|0.0001|TWO_SIDED|95.0|-27.92|-13.94||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-13.94|-27.92|< 0.0001
91613057|NCT00960440|183120336|SUPERIORITY_OR_OTHER||Percentage Difference|23.69|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|12.45|34.92||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||34.92|12.45|<0.0001
91524155|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-11.03||||0.079|TWO_SIDED|95.0|-23.37|1.21||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.21|-23.37|0.079
91524156|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-55.53|||<|0.001|TWO_SIDED|95.0|-70.12|-40.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.85|-70.12|<0.001
91524157|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-57.33|||<|0.001|TWO_SIDED|95.0|-71.9|-42.77||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.77|-71.90|<0.001
91524158|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-7.73||||0.263|TWO_SIDED|95.0|-21.08|5.63||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.63|-21.08|0.263
91524159|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-49.93|||<|0.001|TWO_SIDED|95.0|-64.74|-35.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-35.12|-64.74|<0.001
91524160|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-52.75|||<|0.001|TWO_SIDED|95.0|-67.62|-37.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-37.88|-67.62|<0.001
91524161|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-5.51||||0.439|TWO_SIDED|95.0|-19.27|8.25||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.25|-19.27|0.439
91524162|NCT01216163|182923477|SUPERIORITY_OR_OTHER||Difference in proportion|-47.72|||<|0.001|TWO_SIDED|95.0|-62.62|-32.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-32.83|-62.62|<0.001
91613058|NCT00960440|183120336|SUPERIORITY_OR_OTHER||Percentage Difference|17.23|STANDARD_ERROR_OF_MEAN|5.7||0.0024|TWO_SIDED|95.0|6.06|28.41||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||28.41|6.06|0.0024
91613059|NCT00960440|183120337|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.38|-0.17||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.17|-0.38|<0.0001
91613060|NCT00960440|183120337|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.36|-0.15||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.15|-0.36|<0.0001
91790016|NCT02312687|183459280|SUPERIORITY||LS Mean|-18.77||||0.0094|TWO_SIDED|95.0|-32.93|-4.6||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-4.60|-32.93|0.0094
91613061|NCT00960440|183120338|SUPERIORITY_OR_OTHER||Percentage Difference|9.53|STANDARD_ERROR_OF_MEAN|3.05||0.0017|TWO_SIDED|95.0|3.54|15.51||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.51|3.54|0.0017
91613062|NCT00960440|183120338|SUPERIORITY_OR_OTHER||Percentage Difference|5.05|STANDARD_ERROR_OF_MEAN|2.57||0.0496|TWO_SIDED|95.0|0.0|10.1||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.10|0.00|0.0496
91613063|NCT03504774|183120383|OTHER||Mean Difference (Net)|0.6||||0.3|TWO_SIDED||||||Mixed Models Analysis|||analysis of the change from baseline in CD28 expression||||0.30
91613064|NCT03504774|183120384|OTHER||Mean Difference (Net)|0.9||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.82
91613065|NCT03504774|183120384|OTHER||Mean Difference (Net)|1.2||||0.053|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis on the change from baseline to week 58||||0.053
91613066|NCT03504774|183120384|OTHER||Mean Difference (Net)|0.3||||0.062|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.062
91613067|NCT03504774|183120384|OTHER||Mean Difference (Net)|0.2||||0.3|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.30
91613068|NCT03504774|183120384|OTHER||Mean Difference (Net)|1.0||||0.54|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 58||||0.54
91613069|NCT03504774|183120384|OTHER||Mean Difference (Net)|1.2||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.82
91613070|NCT03504774|183120385|OTHER||Mean Difference (Net)|4.8||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.25
91613071|NCT03504774|183120385|OTHER||Mean Difference (Net)|10.8||||0.24|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.24
91613072|NCT03504774|183120385|OTHER||Mean Difference (Net)|6.0||||0.61|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.61
91613073|NCT03504774|183120385|OTHER||Mean Difference (Net)|8.5||||0.034|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.034
91613074|NCT03504774|183120385|OTHER||Mean Difference (Net)|0.8||||0.45|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.45
91613075|NCT03504774|183120385|OTHER||Mean Difference (Net)|7.7||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.12
91613076|NCT03504774|183120385|OTHER||Mean Difference (Net)|1.0||||0.83|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.83
91790017|NCT02312687|183459280|SUPERIORITY||LS Mean|-25.72|||<|0.0001|TWO_SIDED|95.0|-36.89|-14.54||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-14.54|-36.89|< 0.0001
91790018|NCT02312687|183459281|SUPERIORITY||LS Mean|4.68||||0.1673|TWO_SIDED|95.0|-1.96|11.32||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||11.32|-1.96|0.1673
91613077|NCT03504774|183120385|OTHER||Mean Difference (Net)|2.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.67
91613078|NCT03504774|183120385|OTHER||Mean Difference (Net)|1.0||||0.8|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.80
91613079|NCT03504774|183120385|OTHER||Mean Difference (Net)|1.7||||0.46|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.46
91613080|NCT03504774|183120385|OTHER||Mean Difference (Net)|3.2||||0.48|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.48
91613081|NCT03504774|183120385|OTHER||Mean Difference (Net)|3.2||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.25
91613082|NCT03504774|183120385|OTHER||Mean Difference (Net)|2.6||||0.14|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.14
91613083|NCT03504774|183120385|OTHER||Mean Difference (Net)|0.6||||0.73|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.73
91613084|NCT03504774|183120385|OTHER||Mean Difference (Net)|2.0||||0.16|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.16
91613085|NCT03504774|183120385|OTHER||Mean Difference (Net)|1.8||||0.47|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.47
91613086|NCT03504774|183120385|OTHER||Mean Difference (Net)|1.1||||0.84|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.84
91613087|NCT03504774|183120385|OTHER||Mean Difference (Net)|0.7||||0.55|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.55
91613088|NCT03504774|183120386|OTHER||Mean Difference (Net)|2269.0||||0.23|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.23
91613089|NCT03504774|183120386|OTHER||Mean Difference (Net)|1311.0||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.12
91613090|NCT03504774|183120386|OTHER||Mean Difference (Net)|958.0||||0.79|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.79
91613091|NCT03504774|183120386|OTHER||Mean Difference (Net)|347.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.29
91613092|NCT03504774|183120386|OTHER||Mean Difference (Net)|4364.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.29
91613093|NCT03504774|183120386|OTHER||Mean Difference (Net)|4017.0||||0.42|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.42
91613094|NCT02385123|183120388|OTHER||||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613095|NCT02385123|183120389|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91790019|NCT02312687|183459281|SUPERIORITY||LS Mean|-2.68||||0.233|TWO_SIDED|95.0|-7.09|1.72||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1.72|-7.09|0.2330
91790020|NCT02312687|183459281|SUPERIORITY||LS Mean|-7.45|||<|0.0001|TWO_SIDED|95.0|-9.54|-5.36||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-5.36|-9.54|< 0.0001
91790021|NCT02312687|183459281|SUPERIORITY||LS Mean|-8.08|||<|0.0001|TWO_SIDED|95.0|-9.86|-6.29||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-6.29|-9.86|< 0.0001
91790022|NCT02312687|183459281|SUPERIORITY||LS Mean|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.07|-6.95||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-6.95|-13.07|< 0.0001
91790023|NCT02312687|183459281|SUPERIORITY||LS Mean|-10.89|||<|0.0001|TWO_SIDED|95.0|-14.77|-7.02||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-7.02|-14.77|< 0.0001
91790024|NCT02312687|183459282|SUPERIORITY||LS Mean|343.38||||0.0113|TWO_SIDED|95.0|77.66|609.11||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||609.11|77.66|0.0113
91790025|NCT02312687|183459282|SUPERIORITY||LS Mean|41.45||||0.4972|TWO_SIDED|95.0|-78.23|161.13||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||161.13|-78.23|0.4972
91790026|NCT02312687|183459282|SUPERIORITY||LS Mean|-61.96||||0.3288|TWO_SIDED|95.0|-186.34|62.41||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||62.41|-186.34|0.3288
91613096|NCT02385123|183120390|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613097|NCT02385123|183120391|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people|||
91613098|NCT02385123|183120392|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613099|NCT02385123|183120393|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613100|NCT02385123|183120394|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613101|NCT02385123|183120395|OTHER|||||||||||||||||A single group analysis was used to determine this outcome measure.|A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613102|NCT02385123|183120396|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613103|NCT02385123|183120397|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613104|NCT02385123|183120398|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613105|NCT02385123|183120399|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613106|NCT02385123|183120400|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91790027|NCT02312687|183459282|SUPERIORITY||LS Mean|-68.62||||0.2772|TWO_SIDED|95.0|-192.39|55.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||55.16|-192.39|0.2772
91790028|NCT02312687|183459282|SUPERIORITY||LS Mean|-53.41||||0.2907|TWO_SIDED|95.0|-152.47|45.66||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||45.66|-152.47|0.2907
91790029|NCT02312687|183459282|SUPERIORITY||LS Mean|-97.46||||0.08|TWO_SIDED|95.0|-206.57|11.65||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||11.65|-206.57|0.0800
91790030|NCT02312687|183459283|SUPERIORITY||LS Mean|72.45|||<|0.0001|TWO_SIDED|95.0|39.21|105.7||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||105.70|39.21|< 0.0001
91790031|NCT02312687|183459283|SUPERIORITY||LS Mean|44.4|||<|0.0001|TWO_SIDED|95.0|30.34|58.47||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||58.47|30.34|< 0.0001
91790032|NCT02312687|183459283|SUPERIORITY||LS Mean|28.3||||0.0002|TWO_SIDED|95.0|13.24|43.37||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||43.37|13.24|0.0002
91790033|NCT02312687|183459283|SUPERIORITY||LS Mean|27.02|||<|0.0001|TWO_SIDED|95.0|13.81|40.22||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||40.22|13.81|< 0.0001
91790034|NCT02312687|183459283|SUPERIORITY||LS Mean|13.02||||0.1195|TWO_SIDED|95.0|-3.37|29.4||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||29.40|-3.37|0.1195
91524163|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.294|TWO_SIDED|95.0|-3.59|1.17||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.17|-3.59|0.294
91613107|NCT02385123|183120401|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613108|NCT02385123|183120403|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613109|NCT02385123|183120404|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613110|NCT02385123|183120405|OTHER|Single group analysis.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91790035|NCT02312687|183459283|SUPERIORITY||LS Mean|43.12||||0.2009|TWO_SIDED|95.0|-22.96|109.2||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||109.20|-22.96|0.2009
91613111|NCT02385123|183120406|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613112|NCT02385123|183120407|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613113|NCT02385123|183120408|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613114|NCT02385123|183120409|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
91613115|NCT04498910|183120410|SUPERIORITY||Difference in Estimated change|-1.1|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-3.6|1.2|||Bayesian Mixed Model Analysis|||||1.2|-3.6|
91613116|NCT04498910|183120411|SUPERIORITY||Difference in Estimated change|-1.5|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-4.2|1.0|||Bayesian Mixed Model Analysis|||||1.0|-4.2|
91613117|NCT02345434|183120419|SUPERIORITY||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-6.35|13.4||||||||13.4|-6.35|
91613118|NCT02345434|183120420|SUPERIORITY||Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-3.68|2.1||||||||2.1|-3.68|
91654888|NCT03552757|183202511|SUPERIORITY||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|3.58|6.64|||Regression, Logistic|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||6.64|3.58|<0.0001
91613119|NCT02553915|183120451|OTHER|Comparisons were made for each biomarker within each arm pre and post 12 weeks of treatment.|||||<|0.1|||||||Kruskal-Wallis|||To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma IL-6 levels or in mitogen-stimulated PBMC TNF-α expression and secretion, when compared with placebo. \[Time Frame: 12 weeks\]. Comparisons were made within each arm pre and post 12 weeks of treatment.||||<0.10
91613120|NCT02553915|183120452|SUPERIORITY||||||<|0.1|||||||ANOVA|||"To evaluate:~1. whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and~2. whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression mediate changes observed in ratings of depression.~\[Time Frame: 12 weeks\]"||||<0.1
91613121|NCT02553915|183120453|OTHER||||||<|0.01|||||||Kruskal-Wallis|||Change in IDS-C30 scores were compared pre and post 12 weeks of treatment with each intervention, within each arm.||||<0.01
91613122|NCT02553915|183120454|OTHER|Exploratory.|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in mitogen-stimulated PBMC IL-6. \[Time Frame: 12 weeks\] Comparisons were made between pre and post treatment levels in each of the 4 treatment arms.||||<0.1
91613123|NCT02553915|183120455|OTHER|Exploratory|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes. \[Time Frame: 12 weeks\] (We evaluated gene expression of IL-6 and TNF-α.)||||<0.1
91613124|NCT03078608|183120543|SUPERIORITY||F statistic|0.0||||1|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||1.00
91613125|NCT03078608|183120544|SUPERIORITY||F statistic|2.58||||0.11|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.11
91613126|NCT03078608|183120545|SUPERIORITY||F statistic|0.07||||0.79|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.79
91613127|NCT03078608|183120546|SUPERIORITY||F statistic|1.17||||0.29|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.29
91613128|NCT03078608|183120547|SUPERIORITY||F statistic|0.18||||0.67|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.67
91613129|NCT03078608|183120548|SUPERIORITY||F statistic|1.41||||0.24|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.24
91613130|NCT03078608|183120549|SUPERIORITY||F statistic|1.36||||0.25|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.25
91613131|NCT03078608|183120550|SUPERIORITY||F statistic|0.53||||0.47|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.47
91613132|NCT03078608|183120551|SUPERIORITY||F statistic|1.54||||0.23|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.23
91613133|NCT03078608|183120552|SUPERIORITY||F statistic|0.8||||0.39|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.39
91790036|NCT00906971|183459288|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of defecations was recorded.|||||<|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||<0.05
91710548|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.23|0.33|||t-test, 2 sided|||FEV1 Day 8 (0.25 hrs post-dose)||0.33|0.23|<0.0001
91524164|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|1.21||||0.458|TWO_SIDED|95.0|-1.16|3.58||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.58|-1.16|0.458
91710549|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.26|0.37|||t-test, 2 sided|||FEV1 Day 8 (1 hrs post-dose)||0.37|0.26|<0.0001
91710550|NCT02634983|183313757|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|90.0|0.26|0.38|||t-test, 2 sided|||FEV1 Day 8 (2 hrs post-dose)||0.38|0.26|<0.0001
91710551|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|90.0|0.15|0.33|||t-test, 2 sided|||FVC Day 1 (0.25 hrs post-dose)||0.33|0.15|<0.0001
91790037|NCT00906971|183459289|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of fecal incontinence was recorded reported at the beginning of the study|||||>|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||>0.05
91613134|NCT02760407|183120576|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|97.5|0.183|0.352|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q4w treatment group at Week 12 was expected to be at least 50% resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.352|0.183|<0.0001
91790038|NCT00223236|183459294|SUPERIORITY_OR_OTHER|||||||0.4637|||||||Chi-squared|df=1 n=34||Null hypothsis is no group association in cocaine use.||||.4637
91790039|NCT01007253|183459298|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean eye symptoms score difference among the four treatment groups.||||<0.001
91710552|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 1 (1 hrs post-dose)||0.45|0.25|<0.0001
91790040|NCT01007253|183459299|SUPERIORITY_OR_OTHER|||||||0.05|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean nasal symptoms score difference among the four treatment groups.||||0.05
91790041|NCT01007253|183459300|SUPERIORITY_OR_OTHER|||||||0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean sneeze difference among the four treatment groups.||||0.001
91613135|NCT02760407|183120576|SUPERIORITY||Risk Difference (RD)|0.258|||<|0.0001|TWO_SIDED|97.5|0.171|0.341|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q2w treatment group at Week 12 was expected to be at least 55%, resulting in an expected difference in ACR20 response rate of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.341|0.171|<0.0001
91790042|NCT01007253|183459301|SUPERIORITY_OR_OTHER|||||||0.11|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean histamine level difference among the four treatment groups.||||0.11
91790043|NCT01007253|183459302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean tryptase level difference among the four treatment groups.||||<0.001
91790044|NCT01206387|183459328|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
91790045|NCT01206387|183459329|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91790046|NCT01206387|183459330|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91790047|NCT01206387|183459331|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91790048|NCT01206387|183459332|SUPERIORITY_OR_OTHER|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
91790049|NCT01895361|183459350|OTHER||Hodges-Lehmann median absolute diff.|-1.01|||=|0.01|TWO_SIDED|95.0|-2.0|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crisis history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-2.00|= 0.010
91790050|NCT01895361|183459350|OTHER||Hodges-Lehmann median absolute diff.|-0.69|||=|0.18|TWO_SIDED|95.0|-1.84|0.02|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.02|-1.84|= 0.180
91790051|NCT01895361|183459351|OTHER||Change vs placebo (%)|-45.3|||||ONE_SIDED|||||||||||||
91790052|NCT01895361|183459351|OTHER||Change vs placebo (%)|-32.6|||||ONE_SIDED|||||||||||||
91790053|NCT01895361|183459352|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.45|TWO_SIDED|95.0|-4.36|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-4.36|= 0.450
91790054|NCT01895361|183459352|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.837|TWO_SIDED|95.0|-3.9|2.61|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||2.61|-3.90|= 0.837
91790055|NCT01895361|183459353|OTHER||Hazard Ratio (HR)|0.495|||=|0.001|TWO_SIDED|95.0|0.331|0.741|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.741|0.331|= 0.001
91790056|NCT01895361|183459353|OTHER||Hazard Ratio (HR)|0.752|||=|0.136|TWO_SIDED|95.0|0.515|1.097|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.097|0.515|= 0.136
91790057|NCT01895361|183459354|OTHER||Hazard Ratio (HR)|0.534|||=|0.022|TWO_SIDED|95.0|0.329|0.866|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.866|0.329|= 0.022
91790058|NCT01895361|183459354|OTHER||Hazard Ratio (HR)|0.693|||=|0.1|TWO_SIDED|95.0|0.44|1.092|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.092|0.440|= 0.100
91790059|NCT01895361|183459355|OTHER||Hodges-Lehmann median absolute diff.|-1.0|||=|0.015|TWO_SIDED|95.0|-1.98|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.98|= 0.015
91790060|NCT01895361|183459355|OTHER||Hodges-Lehmann median absolute diff.|-0.87|||=|0.12|TWO_SIDED|95.0|-1.77|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.77|= 0.120
91790061|NCT01895361|183459356|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.78|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|0.00|= 0.780
91790062|NCT01895361|183459356|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.868|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|0.00|= 0.868
91790063|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0056
91790064|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0866
91790065|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0568
91790066|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0130
91790067|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0188||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0188
91790068|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6394||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6394
91613136|NCT02760407|183120577|SUPERIORITY||Risk Difference (RD)|0.224|||<|0.0001|TWO_SIDED|95.0|0.148|0.298|||Chi-squared|2x2 chi-square test||The ACR20 response rate for adalimumab was expected to be at least 52.5% at Week 12.||0.298|0.148|<0.0001
91613137|NCT02760407|183120577|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.045|||||TWO_SIDED|97.5|-0.022|0.112||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.112|-0.022|
91613138|NCT02760407|183120577|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.034|||||TWO_SIDED|97.5|-0.035|0.102||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.102|-0.035|
91790069|NCT00282464|183459358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7707||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7707
91613139|NCT02760407|183120578|SUPERIORITY||Risk Difference (RD)|0.332|||<|0.0001|TWO_SIDED|97.5|0.257|0.397|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 22% in the 64 mg q4w OKZ group, resulting in an expected difference of 12 percentage points between respective OKZ group and placebo.||0.397|0.257|<0.0001
91613140|NCT02760407|183120578|SUPERIORITY||Risk Difference (RD)|0.325|||<|0.0001|TWO_SIDED|97.5|0.25|0.391|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 30% in the 64 mg q2w OKZ group, resulting in an expected difference of 20 percentage points between respective OKZ group and placebo.||0.391|0.250|<0.0001
91613141|NCT02760407|183120579|SUPERIORITY||Risk Difference (RD)|0.256|||<|0.0001|TWO_SIDED|95.0|0.191|0.313|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity response rate for adalimumab was expected to be at least 27% at Week 12.||0.313|0.191|<0.0001
91654889|NCT03552757|183202511|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.31|11.97|||Regression, Logistic|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||11.97|6.31|<0.0001
91613142|NCT02760407|183120579|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.076|||||TWO_SIDED|97.5|0.004|0.147||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.147|0.004|
91613143|NCT02760407|183120579|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.069|||||TWO_SIDED|97.5|-0.003|0.141||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.141|-0.003|
91613144|NCT02760407|183120580|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.29|-0.09|||ANCOVA|||||-0.09|-0.29|<0.0001
91613145|NCT02760407|183120580|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.33|-0.12|||ANCOVA|||||-0.12|-0.33|<0.0001
91613146|NCT02760407|183120580|OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.28|-0.1||||||||-0.10|-0.28|
91613147|NCT02760407|183120581|SUPERIORITY||Risk Difference (RD)|0.275|||<|0.0001|TWO_SIDED|97.5|0.192|0.349|||Chi-squared|2x2 chi-square test||||0.349|0.192|<0.0001
91613148|NCT02760407|183120581|SUPERIORITY||Risk Difference (RD)|0.278|||<|0.0001|TWO_SIDED|97.5|0.195|0.353|||Chi-squared|2x2 chi-square test||||0.353|0.195|<0.0001
91790070|NCT00282464|183459359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2185||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2185
91790071|NCT00282464|183459359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4124||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.4124
91790072|NCT00282464|183459359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6098
91790073|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0005
91790074|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0099
91790075|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0423||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0423
91790076|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0618||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0618
91790077|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0451||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0451
91524165|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|6.81||||0.073|TWO_SIDED|95.0|1.57|12.06||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.06|1.57|0.073
91790078|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2633||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.2633
91524166|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|1.96||||0.583|TWO_SIDED|95.0|-4.94|8.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.85|-4.94|0.583
91524167|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|4.81||||0.137|TWO_SIDED|95.0|0.14|9.49||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.49|0.14|0.137
91524168|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|23.86|||<|0.001|TWO_SIDED|95.0|14.81|32.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.91|14.81|<0.001
91524169|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|8.45||||0.165|TWO_SIDED|95.0|-3.43|20.33||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.33|-3.43|0.165
91524170|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|15.46||||0.006|TWO_SIDED|95.0|7.66|23.26||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.26|7.66|0.006
91524171|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|29.41|||<|0.001|TWO_SIDED|95.0|19.78|39.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.05|19.78|<0.001
91524172|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|4.61||||0.497|TWO_SIDED|95.0|-8.78|17.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.99|-8.78|0.497
91524173|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|25.13|||<|0.001|TWO_SIDED|95.0|15.81|34.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.46|15.81|<0.001
91524174|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|31.78|||<|0.001|TWO_SIDED|95.0|20.03|43.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||43.53|20.03|<0.001
91524175|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|6.7||||0.349|TWO_SIDED|95.0|-7.38|20.79||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.79|-7.38|0.349
91524176|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|25.34|||<|0.001|TWO_SIDED|95.0|13.73|36.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.94|13.73|<0.001
91524177|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|37.64|||<|0.001|TWO_SIDED|95.0|25.47|49.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.81|25.47|<0.001
91613149|NCT02760407|183120581|OTHER||Risk Difference (RD)|0.237|||||TWO_SIDED|95.0|0.165|0.303||||||||0.303|0.165|
91613150|NCT02760407|183120582|SUPERIORITY||Risk Difference (RD)|0.08||||0.0003|TWO_SIDED|97.5|0.031|0.123|||Chi-squared|2x2 chi-square test||||0.123|0.031|0.0003
91613151|NCT02760407|183120582|SUPERIORITY||Risk Difference (RD)|0.069||||0.001|TWO_SIDED|97.5|0.02|0.111|||Chi-squared|2x2 chi-square test||||0.111|0.020|0.001
91790079|NCT00282464|183459360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2206||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.2206
91613152|NCT02760407|183120582|OTHER||Risk Difference (RD)|0.089|||||TWO_SIDED|95.0|0.046|0.127||||||||0.127|0.046|
91613153|NCT02522377|183120583|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|3.28||0.72|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.72
91613154|NCT02522377|183120584|SUPERIORITY|Superiority test based upon group differences pooled across infusions in mixed effect model|Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|6.4||0.77|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=7.836.|Midazolam - Ketamine Infusions|||||0.77
91613155|NCT02522377|183120585|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.4|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.40
91613156|NCT02522377|183120586|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.54||0.009|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.3634.|Midazolam - Ketamine Infusions|||||0.009
91613157|NCT02522377|183120587|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|3.71||0.34|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.34
91613158|NCT02522377|183120588|SUPERIORITY||Odds Ratio (OR)|0.36||||0.58|TWO_SIDED|95.0|0.01|7.2|||Fisher Exact||Odds Ratio of Midazolam (numerator) to Ketamine Infusions (denominator)|||7.20|0.01|0.58
91654890|NCT00571428|183202551|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.011||||||90.0|-0.015|0.037|||Mixed Models Analysis|Treatment group, treatment sequence, predose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||0.037|-0.015|
91613159|NCT01158950|183120589|SUPERIORITY|||||||0.032||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale.||||0.032
91613160|NCT01158950|183120590|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|Statistical tests are computed across multiple subregions (voxels) within each area. Thus, the correlation coefficient above is a summary score.||||||< 0.05
91613161|NCT01765712|183120611|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED|95.0|-1.99|1.03|||t-test, 2 sided|||||1.03|-1.99|0.55
91613162|NCT02137772|183120637|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.5|||<|0.0001|TWO_SIDED|95.0|-32.5|-14.6||A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.6|-32.5|<0.0001
91613163|NCT02137772|183120638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
91613164|NCT02137772|183120639|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-22.6||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.6|-39.9|<0.0001
91613165|NCT02137772|183120640|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.4||||0.4056|TWO_SIDED|95.0|-4.0|3.2||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||3.2|-4.0|0.4056
91613166|NCT02137772|183120641|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0||||0.2258|TWO_SIDED|95.0|-3.5|1.5||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||1.5|-3.5|0.2258
91654891|NCT00571428|183202552|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.062||||||90.0|0.035|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.090|0.035|
91790080|NCT00282464|183459361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9863||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.9863
91790081|NCT00282464|183459361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1017||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.1017
91790082|NCT00282464|183459361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4033||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.4033
91790083|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||No multiple comparison adjustment is applicable. Statistical significance level was 0.05|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.002
91790084|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.019
91790085|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.038
91790086|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.069
91790087|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.053
91790088|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.||||0.154
91613167|NCT02137772|183120642|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.0|||<|0.0001|TWO_SIDED|95.0|-39.6|-22.4||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.4|-39.6|<0.0001
91613168|NCT02137772|183120643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-14.3||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.3|-32.3|<0.0001
91613169|NCT02137772|183120644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
91613170|NCT03290300|183120652|OTHER||||||<|0.0001||||||The pre-specified threshold for statistical significance was p\<0.05.|ANOVA|Repeated measures ANOVA with multiple comparisons to baseline||||||<0.0001
91613171|NCT03320512|183120681|SUPERIORITY||Average Treatment Effect|0.15||||0.04965|TWO_SIDED|95.0|0.0|0.29|||TMLE estimation of ATE and Wald test|Targeted Maximum Likelihood Estimation (TMLE) Average Treatment Effect (ATE)||Month 3 The analysis includes the intent-to-treat population||0.29|0.00|0.04965
91613172|NCT03320512|183120681|SUPERIORITY||Average Treatment Effect|-0.04||||0.62|TWO_SIDED|95.0|-0.21|0.13|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.13|-0.21|0.62
91613173|NCT03320512|183120682|SUPERIORITY||Average Treatment Effect|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.26|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population||0.26|-0.03|0.11
91613174|NCT03320512|183120682|SUPERIORITY||Average Treatment Effect|0.06||||0.38|TWO_SIDED|95.0|-0.08|0.21|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.21|-0.08|0.38
91613175|NCT03320512|183120683|SUPERIORITY||Average Treatment Effect|0.04||||0.68|TWO_SIDED|95.0|-0.09|0.16||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.16|-0.09|0.68
91613176|NCT03320512|183120683|SUPERIORITY||Average Treatment Effect|0.11||||0.53|TWO_SIDED|95.0|-0.03|0.25||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.25|-0.03|0.53
91613177|NCT03320512|183120684|SUPERIORITY||Average Treatment Effect|0.06||||0.53|TWO_SIDED|95.0|-0.02|0.15||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.15|-0.02|0.53
91790089|NCT00282464|183459362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.007
91790090|NCT00282464|183459363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.112
91790091|NCT00282464|183459363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.352
91790092|NCT00282464|183459363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.873
91790093|NCT00282464|183459364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.305
91790094|NCT00282464|183459364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.510
91613178|NCT03320512|183120684|SUPERIORITY||Average Treatment Effect|0.0||||0.96|TWO_SIDED|95.0|-0.12|0.12||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.12|-0.12|0.96
91654892|NCT00571428|183202553|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.035||||||90.0|-0.079|0.008|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.008|-0.079|
91654893|NCT00571428|183202554|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.03||||||90.0|-0.086|0.026|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.026|-0.086|
91654894|NCT00571428|183202559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.694||||||90.0|0.525|2.862|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||2.862|0.525|
91654895|NCT00571428|183202560|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.052||||||90.0|0.015|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect||||0.090|0.015|
91790095|NCT00282464|183459364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.710
91613179|NCT03320512|183120685|SUPERIORITY||Average Treatment Effect|0.08||||0.93|TWO_SIDED|95.0|-0.84|1.0||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.00|-0.84|0.93
91613180|NCT03320512|183120685|SUPERIORITY||Average Treatment Effect|-1.12||||0.6|TWO_SIDED|95.0|-4.16|1.91||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.91|-4.16|0.60
91790096|NCT00282464|183459365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.026
91613181|NCT03320512|183120686|SUPERIORITY||Average Treatment Effect|0.73||||0.6|TWO_SIDED|95.0|-1.03|2.48||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||2.48|-1.03|0.60
91613182|NCT03320512|183120686|SUPERIORITY||Average Treatment Effect|-0.91||||0.6|TWO_SIDED|95.0|-2.86|1.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.04|-2.86|0.60
91654896|NCT00386009|183202566|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.068
91654897|NCT00386009|183202567|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.626
91654898|NCT00386009|183202568|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
91654899|NCT00386009|183202569|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.837
91654900|NCT00386009|183202570|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.400
91790097|NCT00282464|183459365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.223
91710553|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|90.0|0.2|0.42|||t-test, 2 sided|||FVC Day 1 (2 hrs post-dose)||0.42|0.20|<0.0001
91710554|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 8 (-0.75 hrs post-dose)||0.45|0.25|<0.001
91710555|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.19|0.37|||t-test, 2 sided|||FVC Day 8 (-0.25 hrs post-dose)||0.37|0.19|<0.0001
91710556|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.53|||t-test, 2 sided|||FVC Day 8 (0.25 hrs post-dose)||0.53|0.33|<0.0001
91710557|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.36|0.54|||t-test, 2 sided|||FVC Day 8 (1 hrs post-dose)||0.54|0.36|<0.0001
91790098|NCT00282464|183459365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.848||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.848
91790099|NCT00282464|183459366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.381
91613183|NCT03320512|183120687|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.2|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.20|0.60
91613184|NCT03320512|183120687|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.21|0.09||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.09|-0.21|0.60
91613185|NCT03320512|183120687|SUPERIORITY||Average Treatment Effect|-0.13||||0.53|TWO_SIDED|95.0|-0.3|0.03||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.03|-0.30|0.53
91613186|NCT03320512|183120687|SUPERIORITY||Average Treatment Effect|-0.08||||0.6|TWO_SIDED|95.0|-0.24|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.24|0.60
91613187|NCT03320512|183120687|SUPERIORITY||Average Treatment Effect|-0.11||||0.53|TWO_SIDED|95.0|-0.25|0.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.04|-0.25|0.53
91613188|NCT03320512|183120687|SUPERIORITY||Average Treatment Effect|-0.07||||0.6|TWO_SIDED|95.0|-0.2|0.07||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.07|-0.20|0.60
91710558|NCT02634983|183313758|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.55|||t-test, 2 sided|||FVC Day 8 (2 hrs post-dose)||0.55|0.33|<0.0001
91710559|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.17|STANDARD_ERROR_OF_MEAN|0.56||0.0006|TWO_SIDED|90.0|1.21|3.12|||t-test, 2 sided|||FEV1/FVC Day 1 (0.25 hrs post-dose)||3.12|1.21|0.0006
91790100|NCT00282464|183459366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.676||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.676
91790101|NCT00282464|183459366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.295
91790102|NCT00282464|183459367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.068
91790103|NCT00282464|183459367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.043
91790104|NCT00282464|183459367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.404||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.404
91613189|NCT03320512|183120688|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.07|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.29|-0.07|
91613190|NCT03320512|183120688|SUPERIORITY||Average Treatment Effect|0.19|||||TWO_SIDED|95.0|0.03|0.34|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.34|0.03|
91654901|NCT00386009|183202571|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.864
91654902|NCT00386009|183202572|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.340
91654903|NCT00386009|183202573|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
91790105|NCT00282464|183459368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.899
91654904|NCT00386009|183202574|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.609
91790106|NCT00282464|183459368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.739
91790107|NCT00282464|183459368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.797||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.797
91790108|NCT00282464|183459369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.434
91790109|NCT00282464|183459369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.777||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.777
91613191|NCT03320512|183120688|SUPERIORITY||Average Treatment Effect|-0.06|||||TWO_SIDED|95.0|-0.27|0.15|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.15|-0.27|
91613192|NCT03320512|183120688|SUPERIORITY||Average Treatment Effect|-0.02|||||TWO_SIDED|95.0|-0.21|0.16|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.16|-0.21|
91613193|NCT03320512|183120689|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.05|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.05|
91654905|NCT00386009|183202575|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.427
91613194|NCT03320512|183120689|SUPERIORITY||Average Treatment Effect|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.29|-0.04|
91613195|NCT03320512|183120689|SUPERIORITY||Average Treatment Effect|0.09|||||TWO_SIDED|95.0|-0.08|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.08|
91654906|NCT00386009|183202576|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
91654907|NCT00386009|183202577|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.090
91654908|NCT00386009|183202578|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
91654909|NCT00386009|183202581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
91710560|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|0.75||0.0106|TWO_SIDED|90.0|0.78|3.33|||t-test, 2 sided|||FEV1/FVC Day 1 (1 hrs post-dose)||3.33|0.78|0.0106
91790110|NCT00282464|183459369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.820
91613196|NCT03320512|183120689|SUPERIORITY||Average Treatment Effect|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.19|-0.13|
91613197|NCT03320512|183120690|SUPERIORITY||Average Treatment Effect|0.09||||0.11|TWO_SIDED|95.0|-0.02|0.19|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.19|-0.02|0.11
91654910|NCT00936975|183202606|SUPERIORITY_OR_OTHER||Slope|-6.6084|STANDARD_ERROR_OF_MEAN|1.7644|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE||GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|This was an exploratory study and no a priori assumptions were employed.||||<0.001
91654911|NCT00936975|183202607|SUPERIORITY_OR_OTHER||Slope|-0.0115|STANDARD_ERROR_OF_MEAN|0.0089||0.1945|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.||||0.1945
91613198|NCT03320512|183120690|SUPERIORITY||Average Treatment Effect|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.11|-0.14|0.82
91613199|NCT03320512|183120691|SUPERIORITY||Average Treatment Effect|8.95||||0.05|TWO_SIDED|95.0|0.07|17.83||The a priori threshold for statistical significance is 0.025.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||17.83|0.07|0.05
91654912|NCT00936975|183202608|SUPERIORITY_OR_OTHER||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.3274||0.32|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.32
91710561|NCT02634983|183313759|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|0.66||0.0013|TWO_SIDED|90.0|1.2|3.44|||t-test, 2 sided|||FEV1/FVC Day 1 (2 hrs post-dose)||3.44|1.20|0.0013
91613200|NCT03320512|183120691|SUPERIORITY||Average Treatment Effect|-3.69||||0.45|TWO_SIDED|95.0|-13.33|5.95|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||5.95|-13.33|0.45
91613201|NCT03320512|183120692|SUPERIORITY||Incremental cost effectiveness ratio|25.79|||||TWO_SIDED|95.0|-194.05|236.81|||||The confidence interval was created using percentile bootstrap.|Participants were included if they were at an active site with cost data and had a 3-month binary TFV measure.||236.81|-194.05|
91613202|NCT00638846|183120693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739|||||TWO_SIDED|97.4|1.136|1.739|||Generalized Linear Model||Odds ratio was senofilcon A toric / balafilcon A toric|Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation||1.739|1.136|
91613203|NCT00638846|183120694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.138|||||TWO_SIDED|97.4|0.624|1.138|||Generalized Linear Model||Odds ratio was senofilcon A toric/balafilcon A toric|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.||1.138|0.624|
91613204|NCT00638846|183120695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1307|STANDARD_ERROR_OF_MEAN|0.2856|||TWO_SIDED|97.5|-1.1307|-0.568|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon At toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.||-0.5680|-1.1307|
91613205|NCT00638846|183120696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A is superior to balafilcon A.||0.3680|0.07001|
91613206|NCT00638846|183120697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is -0.4.|Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|0.1648|||TWO_SIDED|97.5|-0.0688|-0.0197|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.||-0.0197|-0.0688|
91613207|NCT00638846|183120698|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.||0.3680|0.07001|
91790111|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.468
91790112|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.110
91790113|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.738
91524178|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|8.85||||0.233|TWO_SIDED|95.0|-5.72|23.42||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.42|-5.72|0.233
91524179|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|28.96|||<|0.001|TWO_SIDED|95.0|17.17|40.75||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||40.75|17.17|<0.001
91524180|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|38.73|||<|0.001|TWO_SIDED|95.0|25.87|51.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.60|25.87|<0.001
91524181|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
91524182|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|29.19|||<|0.001|TWO_SIDED|95.0|16.71|41.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.66|16.71|<0.001
91790114|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.617
91524183|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|36.55|||<|0.001|TWO_SIDED|95.0|23.22|49.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.88|23.22|<0.001
91790115|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.642||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.642
91790116|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.644
91790117|NCT00282464|183459370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.789||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.789
91790118|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.042
91790119|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.088
91524184|NCT01216163|182923478|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
91613208|NCT02746679|183120714|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
91613209|NCT02746679|183120715|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91790120|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.651||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.651
91790121|NCT00282464|183459371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.665
91710825|NCT02504320|183314063|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.7709|||||TWO_SIDED|90.0|0.6767|0.8782|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.8782|0.6767|
91710826|NCT02504320|183314063|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9389|||||TWO_SIDED|90.0|0.8246|1.0689|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0689|0.8246|
91710827|NCT02504320|183314064|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0435|||||TWO_SIDED|90.0|0.984|1.1066|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.1066|0.9840|
91710828|NCT02504320|183314064|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.8777|||||TWO_SIDED|90.0|0.8274|0.9311|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9311|0.8274|
91710829|NCT02504320|183314064|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.954|||||TWO_SIDED|90.0|0.8996|1.0117|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0117|0.8996|
91710830|NCT02504320|183314065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0283|||||TWO_SIDED|90.0|0.9691|1.0911|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0911|0.9691|
91710831|NCT02504320|183314065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9056|||||TWO_SIDED|90.0|0.8516|0.963|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9630|0.8516|
91710832|NCT02504320|183314065|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimates|0.9463|||||TWO_SIDED|90.0|0.8909|1.0051|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0051|0.8909|
91710833|NCT02497404|183314067|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|30.1|62.8||||||||62.8|30.1|
91710834|NCT02497404|183314068|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
91710835|NCT02497404|183314069|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
91710836|NCT02497404|183314070|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|89.7|||||TWO_SIDED|95.0|75.8|97.1||||||||97.1|75.8|
91710837|NCT02497404|183314071|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
91710838|NCT02497404|183314072|OTHER||Proportion (percent)|38.5|||||TWO_SIDED|95.0|23.4|55.4||||||Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.||55.4|23.4|
91710839|NCT02497404|183314073|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the graft failure proportion.|Proportion (percent)|2.6|||||TWO_SIDED|95.0|0.07|13.5||||||||13.5|0.07|
91710840|NCT02497404|183314074|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the GVHD proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
91710841|NCT02497404|183314075|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the high-risk extensive chronic graft-versus-host-disease proportion.|Proportion (percent)|5.1|||||TWO_SIDED|95.0|0.63|15.3||||||||15.3|0.63|
91710842|NCT01408901|183314076|SUPERIORITY||Mean Difference (Final Values)|28.7||||0.052|TWO_SIDED|95.0|5.1|52.3||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||52.3|5.1|0.052
91613991|NCT00431847|183121847|SUPERIORITY_OR_OTHER||Slope|-0.02746|STANDARD_ERROR_OF_MEAN|0.004202|<|0.0001|TWO_SIDED|95.0|-0.03573|-0.01919|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01919|-0.03573|<0.0001
91613992|NCT00431847|183121847|SUPERIORITY_OR_OTHER||Chi-Squared|3.4||||0.3345|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3345
91613993|NCT00431847|183121847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0386|STANDARD_ERROR_OF_MEAN|0.1718||0.8223|TWO_SIDED|95.0|-0.2993|0.3765|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3765|-0.2993|0.8223
91613994|NCT00431847|183121847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2919|STANDARD_ERROR_OF_MEAN|0.2506||0.2448|TWO_SIDED|95.0|-0.2009|0.7848|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.7848|-0.2009|0.2448
91654970|NCT03384745|183202667|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 44 (84.6% \[71.9-93.1\], p\<0.0001) of 52 participants in the M1095 60mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
91527371|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.384|STANDARD_ERROR_OF_MEAN|0.2766|||TWO_SIDED|95.0|-0.162|0.929|||||Comparison of FVC, Day 7, 24 hour|||0.929|-0.162|
91527372|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.233|STANDARD_ERROR_OF_MEAN|3.3333|||TWO_SIDED|95.0|-4.743|9.21|||||Comparison of maximum heart rate Day 1.|||9.210|-4.743|
91527373|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|8.0907|||TWO_SIDED|95.0|-11.2|22.664|||||Comparison of maximum heart rate Day 7.|||22.664|-11.200|
91613995|NCT00431847|183121847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4482|STANDARD_ERROR_OF_MEAN|0.3502||0.2014|TWO_SIDED|95.0|-0.2405|1.1369|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1369|-0.2405|0.2014
91613996|NCT00431847|183121848|SUPERIORITY_OR_OTHER||Slope|-0.0403|STANDARD_ERROR_OF_MEAN|0.007196|<|0.0001|TWO_SIDED|95.0|-0.5446|-0.02613|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.02613|-0.5446|<0.0001
91613997|NCT00431847|183121848|SUPERIORITY_OR_OTHER||Chi-Squared|3.19||||0.3631|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3631
91613998|NCT00431847|183121848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1004|STANDARD_ERROR_OF_MEAN|0.2746||0.7148|TWO_SIDED|95.0|-0.6404|0.4396|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.4396|-0.6404|0.7148
91613999|NCT00431847|183121848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3568|STANDARD_ERROR_OF_MEAN|0.4009||0.3741|TWO_SIDED|95.0|-0.4318|1.1453|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1453|-0.4318|0.3741
91691886|NCT00925704|183278285|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||< 0.001
91691887|NCT00925704|183278286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.039
91527374|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.272|STANDARD_ERROR_OF_MEAN|3.239|||TWO_SIDED|95.0|-8.051|5.507|||||Comparison of maximum heart rate Day 1.|||5.507|-8.051|
91614000|NCT00431847|183121848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2969|STANDARD_ERROR_OF_MEAN|0.5609||0.0213|TWO_SIDED|95.0|0.1938|2.4|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.4000|0.1938|0.0213
91614001|NCT00431847|183121849|SUPERIORITY_OR_OTHER||Slope|-0.02776|STANDARD_ERROR_OF_MEAN|0.004706|<|0.0001|TWO_SIDED|95.0|-0.03702|-0.0185|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01850|-0.03702|<0.0001
91614002|NCT00431847|183121849|SUPERIORITY_OR_OTHER||Chi-Squared|3.88||||0.2752|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.2752
91614003|NCT00431847|183121849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3079|STANDARD_ERROR_OF_MEAN|0.1918||0.1094|TWO_SIDED|95.0|-0.6851|0.06941|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.06941|-0.6851|0.1094
91614004|NCT00431847|183121849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0428|STANDARD_ERROR_OF_MEAN|0.28||0.8786|TWO_SIDED|95.0|-0.5079|0.5935|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5935|-0.5079|0.8786
91654971|NCT03384745|183202667|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the M1095 120mg normal load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
91691888|NCT00925704|183278286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.305
91614005|NCT00431847|183121849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6759|STANDARD_ERROR_OF_MEAN|0.391||0.0847|TWO_SIDED|95.0|-0.09297|1.4448|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.4448|-0.09297|0.0847
91614006|NCT00431847|183121850|SUPERIORITY_OR_OTHER||Slope|-0.03645|STANDARD_ERROR_OF_MEAN|0.005913|<|0.0001|TWO_SIDED|95.0|-0.04808|-0.02481|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02481|-0.04808|<0.0001
91614007|NCT00431847|183121850|SUPERIORITY_OR_OTHER||Chi-Squared|3.16||||0.3677|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3677
91710843|NCT01408901|183314076|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.91|TWO_SIDED|95.0|-30.2|17.6||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||17.6|-30.2|0.91
91527375|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.988|STANDARD_ERROR_OF_MEAN|7.8616|||TWO_SIDED|95.0|-15.47|17.443|||||Comparison of maximum heart rate Day 7.|||17.443|-15.470|
91527376|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.734|STANDARD_ERROR_OF_MEAN|3.441|||TWO_SIDED|95.0|-4.468|9.936|||||Comparison of mean heart rate Day 1.|||9.936|-4.468|
91614008|NCT00431847|183121850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05816|STANDARD_ERROR_OF_MEAN|0.221||0.7926|TWO_SIDED|95.0|-0.4929|0.3766|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3766|-0.4929|0.7926
91614009|NCT00431847|183121850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1708|STANDARD_ERROR_OF_MEAN|0.3212||0.5953|TWO_SIDED|95.0|-0.461|0.8026|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.8026|-0.4610|0.5953
91614010|NCT00431847|183121850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6873|STANDARD_ERROR_OF_MEAN|0.4482||0.1261|TWO_SIDED|95.0|-0.1943|1.5689|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5689|-0.1943|0.1261
91614011|NCT00431847|183121851|SUPERIORITY_OR_OTHER||Slope|-0.4831|STANDARD_ERROR_OF_MEAN|0.1243||0.0002|TWO_SIDED|95.0|-0.7286|-0.2377|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.2377|-0.7286|0.0002
91614012|NCT00431847|183121851|SUPERIORITY_OR_OTHER||Chi-Squared|3.2||||0.3617|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3617
91614013|NCT00431847|183121851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1574|STANDARD_ERROR_OF_MEAN|2.7573||0.2532|TWO_SIDED|95.0|-2.2715|8.5863|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||8.5863|-2.2715|0.2532
91614014|NCT00431847|183121851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2227|STANDARD_ERROR_OF_MEAN|3.9633||0.758|TWO_SIDED|95.0|-6.5833|9.0286|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||9.0286|-6.5833|0.7580
91614015|NCT00431847|183121851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.1649|STANDARD_ERROR_OF_MEAN|5.3759||0.1837|TWO_SIDED|95.0|-17.7484|3.4187|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.4187|-17.7484|0.1837
91614016|NCT00431847|183121852|SUPERIORITY_OR_OTHER||Slope|0.4741|STANDARD_ERROR_OF_MEAN|0.03909|<|0.0001|TWO_SIDED|95.0|0.3971|0.5511|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.5511|0.3971|<0.0001
91614017|NCT00431847|183121852|SUPERIORITY_OR_OTHER||Chi-Squared|1.83||||0.6075|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6075
91614018|NCT00431847|183121852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9534|STANDARD_ERROR_OF_MEAN|1.2763||0.4558|TWO_SIDED|95.0|-3.4675|1.5607|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5607|-3.4675|0.4558
91527377|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.783|STANDARD_ERROR_OF_MEAN|2.9409|||TWO_SIDED|95.0|-1.372|10.938|||||Comparison of mean heart rate Day 7.|||10.938|-1.372|
91614019|NCT00431847|183121852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3505|STANDARD_ERROR_OF_MEAN|1.977||0.0914|TWO_SIDED|95.0|-7.2442|0.5432|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5432|-7.2442|0.0914
91614020|NCT00431847|183121852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.37|STANDARD_ERROR_OF_MEAN|3.0921||0.007|TWO_SIDED|95.0|-14.4589|-2.281|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-2.2810|-14.4589|0.007
91614021|NCT00431847|183121853|SUPERIORITY_OR_OTHER||Slope|-0.2169|STANDARD_ERROR_OF_MEAN|0.04148|<|0.0001|TWO_SIDED|95.0|-0.2987|-0.1352|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1352|-0.2987|<0.0001
91614022|NCT00431847|183121853|SUPERIORITY_OR_OTHER||Chi-Squared|6.37||||0.095|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0950
91614023|NCT00431847|183121853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7246|STANDARD_ERROR_OF_MEAN|1.3351||0.5878|TWO_SIDED|95.0|-1.9056|3.3547|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3547|-1.9056|0.5878
91614024|NCT00431847|183121853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2466|STANDARD_ERROR_OF_MEAN|2.0697||0.9053|TWO_SIDED|95.0|-4.3231|3.8299|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.8299|-4.3231|0.9053
91614025|NCT00431847|183121853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3457|STANDARD_ERROR_OF_MEAN|3.2285||0.4682|TWO_SIDED|95.0|-8.7034|4.012|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.0120|-8.7034|0.4682
91654972|NCT03384745|183202667|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 45 (88.2% \[76.1-95.6\], p\<0.0001) of 51 participants in the M1095 120mg augmented load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
91710844|NCT01408901|183314076|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.91|TWO_SIDED|95.0|-25.2|22.4||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||22.4|-25.2|0.91
91691889|NCT02667704|183278332|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|98.85|STANDARD_DEVIATION|11.4|||TWO_SIDED|90.0|91.32|107.01|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||107.010|91.320|
91710845|NCT01408901|183314076|SUPERIORITY||Mean Difference (Final Values)|33.6||||0.02|TWO_SIDED|95.0|9.4|57.7||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||57.7|9.4|0.02
91614026|NCT00431847|183121854|SUPERIORITY_OR_OTHER||Slope|0.04639|STANDARD_ERROR_OF_MEAN|0.03562||0.1938|TWO_SIDED|95.0|-0.02369|0.1165|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1165|-0.02369|0.1938
91614027|NCT00431847|183121854|SUPERIORITY_OR_OTHER||Chi-Squared|2.43||||0.4884|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4884
91710846|NCT01408901|183314077|SUPERIORITY||Hodges-Lehmann estimator|-0.61||||0.49|TWO_SIDED|95.0|-1.67|0.44||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.44|-1.67|0.49
91710847|NCT01408901|183314077|SUPERIORITY||Hodges-Lehmann estimator|-0.67||||0.49|TWO_SIDED|95.0|-1.84|0.51||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.51|-1.84|0.49
91527378|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.074|STANDARD_ERROR_OF_MEAN|3.3103|||TWO_SIDED|95.0|-8.003|5.854|||||Comparison of mean heart rate Day 1.|||5.854|-8.003|
91614028|NCT00431847|183121854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6174|STANDARD_ERROR_OF_MEAN|1.3991||0.6593|TWO_SIDED|95.0|-2.1348|3.3696|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3696|-2.1348|0.6593
91614029|NCT00431847|183121854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4575|STANDARD_ERROR_OF_MEAN|2.0263||0.0889|TWO_SIDED|95.0|-0.528|7.4431|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.4431|-0.5280|0.0889
91614030|NCT00431847|183121854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4499|STANDARD_ERROR_OF_MEAN|2.8061||0.8727|TWO_SIDED|95.0|-5.9692|5.0694|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||5.0694|-5.9692|0.8727
91614031|NCT00431847|183121855|SUPERIORITY_OR_OTHER||Slope|-0.523|STANDARD_ERROR_OF_MEAN|0.08855|<|0.0001|TWO_SIDED|95.0|-0.6973|-0.3486|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.3486|-0.6973|<.0001
91614032|NCT00431847|183121855|SUPERIORITY_OR_OTHER||Chi-Squared|4.89||||0.18|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.1800
91614033|NCT00431847|183121855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.302|STANDARD_ERROR_OF_MEAN|2.8198||0.4151|TWO_SIDED|95.0|-3.253|7.857|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.8570|-3.2530|0.4151
91614034|NCT00431847|183121855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3376|STANDARD_ERROR_OF_MEAN|4.314||0.3157|TWO_SIDED|95.0|-4.1592|12.8344|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.8344|-4.1592|0.3157
91654973|NCT03384745|183202667|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the secukinumab 300mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
91654974|NCT02260492|183202689|EQUIVALENCE|"Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.~Superiority test compares Test with Placebo (p\<0.05) Superiority test compares Reference with Placebo (p\<0.05) (p\<0.05)"|Test/Reference|1.0799|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||"Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:~H01: uT-uR \< -0.20 uR vs. Ha1: -0.20 uR \</= uT- uR (the lower tail) and H02: uT-uR \>0.25 uR vs. Ha2: uT- uR \</=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS"|"Day 1 superiority to placebo:~Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012"|1.25|.8|<0.05
91654975|NCT02260492|183202690|EQUIVALENCE|Standard bioequivalence 90% confidence bounds set at 0.8-1.25.|Test/Reference|1.0475|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANOVA|||Same as the Day 1 analyses|"Week 4 superiority to placebo:~Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035"|1.25|.8|<0.05
91654976|NCT04634409|183202692|SUPERIORITY||Odds Ratio (OR)|0.37||||0.009273|TWO_SIDED|95.0|0.18|0.78|||Regression, Logistic|||||0.78|0.18|0.009273
91654977|NCT04634409|183202692|SUPERIORITY||Odds Ratio (OR)|0.32||||0.000271|TWO_SIDED|95.0|0.18|0.59|||Regression, Logistic|||||0.59|0.18|0.000271
91527379|NCT00453479|182929958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.569|STANDARD_ERROR_OF_MEAN|2.8291|||TWO_SIDED|95.0|-4.353|7.49|||||Comparison of mean heart rate Day 7.|||7.490|-4.353|
91654978|NCT04634409|183202692|SUPERIORITY||Odds Ratio (OR)|0.23||||0.000257|TWO_SIDED|95.0|0.1|0.51|||Regression, Logistic|||||0.51|0.10|0.000257
91654979|NCT04634409|183202692|SUPERIORITY||Odds Ratio (OR)|0.44||||0.013378|TWO_SIDED|95.0|0.23|0.84|||Regression, Logistic|||||0.84|0.23|0.013378
91654980|NCT04634409|183202692|SUPERIORITY||Odds Ratio (OR)|0.24||||0.000318|TWO_SIDED|95.0|0.11|0.52|||Regression, Logistic|||||0.52|0.11|0.000318
91654981|NCT04634409|183202692|SUPERIORITY||Odds Ratio (OR)|0.35||||0.140563|TWO_SIDED|95.0|0.09|1.41|||Regression, Logistic|||||1.41|0.09|0.140563
91654982|NCT04634409|183202693|SUPERIORITY||Odds Ratio (OR)|0.27||||0.000835|TWO_SIDED|95.0|0.12|0.58|||Regression, Logistic|||||0.58|0.12|0.000835
91654983|NCT04634409|183202694|SUPERIORITY||Odds Ratio (OR)|0.56||||0.097231|TWO_SIDED|95.0|0.28|1.11|||Regression, Logistic|||||1.11|0.28|0.097231
91654984|NCT04634409|183202694|SUPERIORITY||Odds Ratio (OR)|0.59||||0.13236|TWO_SIDED|95.0|0.3|1.17|||Regression, Logistic|||||1.17|0.30|0.132360
91654985|NCT04634409|183202700|SUPERIORITY||Odds Ratio (OR)|0.62||||0.769|TWO_SIDED|95.0|0.02|15.57|||Regression, Logistic|||||15.57|0.02|0.769
91654986|NCT04634409|183202700|SUPERIORITY||Odds Ratio (OR)|0.32||||0.494|TWO_SIDED|95.0|0.01|8.12|||Regression, Logistic|||||8.12|0.01|0.494
91654987|NCT04634409|183202700|SUPERIORITY||Odds Ratio (OR)|0.5||||0.671|TWO_SIDED|95.0|0.02|12.51|||Regression, Logistic|||||12.51|0.02|0.671
91654988|NCT04634409|183202700|SUPERIORITY||Odds Ratio (OR)|0.49||||0.663|TWO_SIDED|95.0|0.02|12.27|||Regression, Logistic|||||12.27|0.02|0.663
91654989|NCT04634409|183202700|SUPERIORITY||Odds Ratio (OR)|0.51||||0.68|TWO_SIDED|95.0|0.02|12.76|||Regression, Logistic|||||12.76|0.02|0.680
91654990|NCT04634409|183202700|SUPERIORITY||Odds Ratio (OR)|2.51||||0.584|TWO_SIDED|95.0|0.09|67.88|||Regression, Logistic|||||67.88|0.09|0.584
91654991|NCT04634409|183202702|SUPERIORITY||Odds Ratio (OR)|1.02||||0.979|TWO_SIDED|95.0|0.17|6.06|||Regression, Logistic|||||6.06|0.17|0.979
91654992|NCT04634409|183202702|SUPERIORITY||Odds Ratio (OR)|1.42||||0.675|TWO_SIDED|95.0|0.27|7.39|||Regression, Logistic|||||7.39|0.27|0.675
91654993|NCT04634409|183202705|SUPERIORITY||LSM Difference|-0.67||||0.009|TWO_SIDED|95.0|-1.17|-0.17|||Mixed Models Analysis|||||-0.17|-1.17|0.009
91654994|NCT04634409|183202705|SUPERIORITY||LSM Difference|-0.65||||0.002|TWO_SIDED|95.0|-1.06|-0.24|||Mixed Models Analysis|||||-0.24|-1.06|0.002
91654995|NCT04634409|183202705|SUPERIORITY||LSM Difference|-0.26||||0.263|TWO_SIDED|95.0|-0.72|0.2|||Mixed Models Analysis|||||0.20|-0.72|0.263
91654996|NCT04634409|183202705|SUPERIORITY||LSM Difference|-0.41||||0.083|TWO_SIDED|95.0|-0.87|0.05|||Mixed Models Analysis|||||0.05|-0.87|0.083
91654997|NCT04634409|183202705|SUPERIORITY||LSM Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||||-0.40|-1.35|<0.001
91654998|NCT04634409|183202705|SUPERIORITY||LSM Difference|-0.64||||0.149|TWO_SIDED|95.0|-1.52|0.23|||Mixed Models Analysis|||||0.23|-1.52|0.149
91654999|NCT04634409|183202706|SUPERIORITY||LSM Difference|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||Mixed Models Analysis|||||-0.31|-1.33|0.002
91614035|NCT00431847|183121855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.825|STANDARD_ERROR_OF_MEAN|6.9715||0.0911|TWO_SIDED|95.0|-1.904|25.5541|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||25.5541|-1.9040|0.0911
91527380|NCT00453479|182929962|SUPERIORITY_OR_OTHER||Ratio|1.139|STANDARD_ERROR_OF_MEAN|0.1939|||TWO_SIDED|90.0|0.811|1.601|||||SE logs is presented as standard error of mean. Comparison of GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.601|0.811|
91614036|NCT00431847|183121856|SUPERIORITY_OR_OTHER||Slope|-0.2888|STANDARD_ERROR_OF_MEAN|0.09078||0.0016|TWO_SIDED|95.0|-0.4675|-0.11|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1100|-0.4675|0.0016
91614037|NCT00431847|183121856|SUPERIORITY_OR_OTHER||Chi-Squared|6.33||||0.0966|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0966
91614038|NCT00431847|183121856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9879|STANDARD_ERROR_OF_MEAN|2.4264||0.2195|TWO_SIDED|95.0|-1.7938|7.7697|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.7697|-1.7938|0.2195
91614039|NCT00431847|183121856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4636|STANDARD_ERROR_OF_MEAN|3.7381||0.5105|TWO_SIDED|95.0|-9.8289|4.9018|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.9018|-9.8289|0.5105
91614040|NCT00431847|183121856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3871|STANDARD_ERROR_OF_MEAN|6.1087||0.0903|TWO_SIDED|95.0|-22.4174|1.6433|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.6433|-22.4174|0.0903
91614041|NCT00431847|183121857|SUPERIORITY_OR_OTHER||Slope|-0.04113|STANDARD_ERROR_OF_MEAN|-0.04113||0.6602|TWO_SIDED|95.0|-0.2252|0.1429|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1429|-0.2252|0.6602
91655000|NCT04634409|183202707|SUPERIORITY||LSM Difference|-0.14||||0.606|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|||||0.41|-0.70|0.606
91614042|NCT00431847|183121857|SUPERIORITY_OR_OTHER||Chi-Squared|1.53||||0.6764|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6764
91655001|NCT04634409|183202707|SUPERIORITY||LSM Difference|-0.38||||0.17|TWO_SIDED|95.0|-0.93|0.17|||Mixed Models Analysis|||||0.17|-0.93|0.170
91710848|NCT01408901|183314077|SUPERIORITY||Hodges-Lehmann estimator|0.36||||0.49|TWO_SIDED|95.0|-0.66|1.38||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.38|-0.66|0.49
91614043|NCT00431847|183121857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4902|STANDARD_ERROR_OF_MEAN|2.6357||0.3458|TWO_SIDED|95.0|-2.7036|7.684|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.6840|-2.7036|0.3458
91710849|NCT01408901|183314077|SUPERIORITY||Hodges-Lehmann estimator|0.48||||0.49|TWO_SIDED|95.0|-0.64|1.59||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.59|-0.64|0.49
91655002|NCT04634409|183202713|SUPERIORITY||Odds Ratio (OR)|0.96||||0.89|TWO_SIDED|95.0|0.53|1.73|||Regression, Logistic|||||1.73|0.53|0.890
91655003|NCT04634409|183202713|SUPERIORITY||Odds Ratio (OR)|1.43||||0.141|TWO_SIDED|95.0|0.89|2.29|||Regression, Logistic|||||2.29|0.89|0.141
91655004|NCT04634409|183202713|SUPERIORITY||Odds Ratio (OR)|1.15||||0.603|TWO_SIDED|95.0|0.67|1.98|||Regression, Logistic|||||1.98|0.67|0.603
91655005|NCT04634409|183202713|SUPERIORITY||Odds Ratio (OR)|1.69||||0.048|TWO_SIDED|95.0|1.0|2.84|||Regression, Logistic|||||2.84|1.00|0.048
91655006|NCT04634409|183202713|SUPERIORITY||Odds Ratio (OR)|1.19||||0.533|TWO_SIDED|95.0|0.69|2.04|||Regression, Logistic|||||2.04|0.69|0.533
91655007|NCT04634409|183202713|SUPERIORITY||Odds Ratio (OR)|1.09||||0.869|TWO_SIDED|95.0|0.4|2.99|||Regression, Logistic|||||2.99|0.40|0.869
91655008|NCT04634409|183202714|SUPERIORITY||Odds Ratio (OR)|1.31||||0.374|TWO_SIDED|95.0|0.72|2.35|||Regression, Logistic|||||2.35|0.72|0.374
91655009|NCT04634409|183202715|SUPERIORITY||Odds Ratio (OR)|1.87||||0.015|TWO_SIDED|95.0|1.13|3.08|||Regression, Logistic|||||3.08|1.13|0.015
91655010|NCT04634409|183202715|SUPERIORITY||Odds Ratio (OR)|1.29||||0.317|TWO_SIDED|95.0|0.78|2.11|||Regression, Logistic|||||2.11|0.78|0.317
91655011|NCT04634409|183202718|SUPERIORITY||Odds Ratio (OR)|1.62||||0.082|TWO_SIDED|95.0|0.94|2.81|||Regression, Logistic|||||2.81|0.94|0.082
91655012|NCT04634409|183202718|SUPERIORITY||Odds Ratio (OR)|1.86||||0.018|TWO_SIDED|95.0|1.11|3.11|||Regression, Logistic|||||3.11|1.11|0.018
91655013|NCT04634409|183202718|SUPERIORITY||Odds Ratio (OR)|1.71||||0.021|TWO_SIDED|95.0|1.09|2.71|||Regression, Logistic|||||2.71|1.09|0.021
91655014|NCT04634409|183202718|SUPERIORITY||Odds Ratio (OR)|1.93||||0.011|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||||3.22|1.16|0.011
91655015|NCT04634409|183202718|SUPERIORITY||Odds Ratio (OR)|2.17||||0.003|TWO_SIDED|95.0|1.3|3.6|||Regression, Logistic|||||3.60|1.30|0.003
91655016|NCT04634409|183202718|SUPERIORITY||Odds Ratio (OR)|1.34||||0.546|TWO_SIDED|95.0|0.52|3.48|||Regression, Logistic|||||3.48|0.52|0.546
91655017|NCT04634409|183202719|SUPERIORITY||Odds Ratio (OR)|1.04||||0.888|TWO_SIDED|95.0|0.6|1.82|||Regression, Logistic|||||1.82|0.60|0.888
91655018|NCT04634409|183202720|SUPERIORITY||Odds Ratio (OR)|1.88||||0.014|TWO_SIDED|95.0|1.13|3.13|||Regression, Logistic|||||3.13|1.13|0.014
91655019|NCT04634409|183202720|SUPERIORITY||Odds Ratio (OR)|1.63||||0.057|TWO_SIDED|95.0|0.98|2.71|||Regression, Logistic|||||2.71|0.98|0.057
91710850|NCT01408901|183314078|SUPERIORITY||Mean Difference (Final Values)|3.6|||<|0.01|TWO_SIDED|95.0|2.1|5.0||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.0|2.1|<0.01
91527381|NCT00453479|182929962|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.2057|||TWO_SIDED|90.0|0.739|1.52|||||SE logs is presented as standard error of mean. Comparison of GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.520|0.739|
91655020|NCT02683187|183202732|EQUIVALENCE|Insulin secretion, determined by insulin or C-peptide values in the 10 minutes after arginine infusion will be compared as a repeated measure for each subject in a 2 x 2 analysis of sitagliptin/placebo and Exendin-9/saline.|Median Difference (Final Values)|371.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
91655021|NCT05665595|183202733|OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.87|1.8|||||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma risk-based stage (IIB/IIC/clinical IIB and IIC/IIIA/IIIB vs IIIC/IIID/IV) and region of enrollment (Asia vs ROW).|||1.80|0.87|
91655022|NCT02122796|183202746|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
91655023|NCT02122796|183202747|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
91655024|NCT02122796|183202749|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
91655025|NCT00234078|183202756|SUPERIORITY_OR_OTHER|||||||0.385||||||versus placebo|t-test, 2 sided|a general linear model||||||0.385
91655026|NCT00234078|183202757|SUPERIORITY_OR_OTHER|||||||0.601||||||versus placebo|t-test, 2 sided|a general linear model||||||0.601
91655027|NCT00234078|183202758|SUPERIORITY_OR_OTHER|||||||0.084||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.084
91655028|NCT00234078|183202758|SUPERIORITY_OR_OTHER|||||||0.02||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.020
91655029|NCT00234078|183202758|SUPERIORITY_OR_OTHER|||||||0.421||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.421
91655030|NCT00234078|183202759|SUPERIORITY_OR_OTHER|||||||0.087||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.087
91655031|NCT00234078|183202759|SUPERIORITY_OR_OTHER|||||||0.004||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.004
91655032|NCT00234078|183202759|SUPERIORITY_OR_OTHER|||||||0.029||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.029
91710851|NCT01408901|183314078|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.44|TWO_SIDED|95.0|-2.1|0.8||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.8|-2.1|0.44
91655033|NCT03471078|183202760|OTHER|The primary efficacy endpoint was tested between avatrombopag and placebo using the Cochran-Mantel-Haenszel 2-sided test at α=0.05, adjusting for the number of eligible chemotherapy agents as collected in IWRS (1 or ≥2 permissible chemotherapy agents).|Mean Difference (Final Values)|-3.0||||0.7186|TWO_SIDED|95.0|-21.7|15.6|||Cochran-Mantel-Haenszel|||||15.6|-21.7|0.7186
91655034|NCT03471078|183202761|OTHER|||||||0.8372|||||||Van Elteren Test|||||||0.8372
91655035|NCT00502775|183202764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.2|-0.6||Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.|ANCOVA|No other strata or covariates, other than investigator, were defined.|Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine|The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.||-0.6|-1.2|<0.001
91655036|NCT00502775|183202764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.1|-0.4|||ANCOVA||Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo|||-0.4|-1.1|<0.001
91655037|NCT00502775|183202764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.374||95.0|-0.2|0.5|||ANCOVA||Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo|||0.5|-0.2|0.374
91655038|NCT05381948|183202777|OTHER||Least Square (LS) Mean|-0.12|STANDARD_ERROR_OF_MEAN|1.199||0.919|TWO_SIDED|95.0|-2.48|2.24|||Mixed Model for Repeated Measures (MMRM)|||||2.24|-2.48|0.919
91655039|NCT05381948|183202777|OTHER||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|1.187||0.795|TWO_SIDED|95.0|-2.63|2.02|||MMRM|||||2.02|-2.63|0.795
91614044|NCT00431847|183121857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2518|STANDARD_ERROR_OF_MEAN|4.0583||0.1969|TWO_SIDED|95.0|-13.2466|2.743|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.7430|-13.2466|0.1969
91614045|NCT00431847|183121857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.9796|STANDARD_ERROR_OF_MEAN|6.5287||0.048|TWO_SIDED|95.0|-25.8429|-0.1162|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.1162|-25.8429|0.0480
91614046|NCT00431847|183121858|SUPERIORITY_OR_OTHER||Slope|-0.2349|STANDARD_ERROR_OF_MEAN|0.1003||0.0199|TWO_SIDED|95.0|-0.4323|-0.03745|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.03745|-0.4323|0.0199
91614047|NCT00431847|183121858|SUPERIORITY_OR_OTHER||Chi-Squared|2.6||||0.4577|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4577
91614048|NCT00431847|183121858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9502|STANDARD_ERROR_OF_MEAN|2.8797||0.7417|TWO_SIDED|95.0|-6.624|4.7236|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.7236|-6.6240|0.7417
91614049|NCT00431847|183121858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.258|STANDARD_ERROR_OF_MEAN|4.4523||0.7778|TWO_SIDED|95.0|-7.5129|10.0289|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||10.0289|-7.5129|0.7778
91614050|NCT00431847|183121858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5232|STANDARD_ERROR_OF_MEAN|7.2532||0.2411|TWO_SIDED|95.0|-5.7608|22.8073|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||22.8073|-5.7608|0.2411
91614051|NCT00431847|183121859|SUPERIORITY_OR_OTHER||Slope|0.1629|STANDARD_ERROR_OF_MEAN|0.08284||0.0504|TWO_SIDED|95.0|-0.00029|0.3261|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.3261|-0.00029|0.0504
91614052|NCT00431847|183121859|SUPERIORITY_OR_OTHER||Chi-Squared|1.45||||0.6942|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6942
91527382|NCT00453479|182929963|SUPERIORITY_OR_OTHER||Ratio|1.408|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|0.934|2.122|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||2.122|0.934|
91614053|NCT00431847|183121859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5241|STANDARD_ERROR_OF_MEAN|2.4216||0.5297|TWO_SIDED|95.0|-3.2469|6.2951|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||6.2951|-3.2469|0.5297
91614054|NCT00431847|183121859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7679|STANDARD_ERROR_OF_MEAN|3.7464||0.3155|TWO_SIDED|95.0|-11.1478|3.612|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.6120|-11.1478|0.3155
91614055|NCT00431847|183121859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7558|STANDARD_ERROR_OF_MEAN|6.092||0.1105|TWO_SIDED|95.0|-21.7515|2.2399|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.2399|-21.7515|0.1105
91614056|NCT00431847|183121860|SUPERIORITY_OR_OTHER||Slope|-0.2979|STANDARD_ERROR_OF_MEAN|0.07538||0.001|TWO_SIDED|95.0|-0.4465|-0.1493|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1493|-0.4465|0.001
91614057|NCT00431847|183121860|SUPERIORITY_OR_OTHER||Chi-Squared|2.72||||0.4361|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4361
91614058|NCT00431847|183121860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9001|STANDARD_ERROR_OF_MEAN|2.6015||0.7297|TWO_SIDED|95.0|-6.0247|4.2246|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.2246|-6.0247|0.7297
91614059|NCT00431847|183121860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.2896|STANDARD_ERROR_OF_MEAN|4.0186||0.2868|TWO_SIDED|95.0|-3.625|12.2043|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.2043|-3.6250|0.2868
91614060|NCT00431847|183121860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0118|STANDARD_ERROR_OF_MEAN|6.2663||0.1516|TWO_SIDED|95.0|-3.327|21.3505|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||21.3505|-3.3270|0.1516
91614061|NCT00431847|183121861|SUPERIORITY_OR_OTHER||Slope|-0.9776|STANDARD_ERROR_OF_MEAN|0.1426|<|0.0001|TWO_SIDED|95.0|-1.2584|-0.6967|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T||-0.6967|-1.2584|<0.0001
91614062|NCT00431847|183121861|SUPERIORITY_OR_OTHER||Chi-Squared|0.78||||0.8548|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.8548
91614063|NCT00431847|183121861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3635|STANDARD_ERROR_OF_MEAN|3.8899||0.3882|TWO_SIDED|95.0|-4.3026|11.0296|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.0296|-4.3026|0.3882
91655040|NCT00520741|183202797|SUPERIORITY_OR_OTHER||Predicted exit rate at 112 days|0.3|||||TWO_SIDED|95.0|0.246|0.355|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.355|0.246|
91614064|NCT00431847|183121861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5029|STANDARD_ERROR_OF_MEAN|5.9044||0.9322|TWO_SIDED|95.0|-12.1376|11.1317|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.1317|-12.1376|0.9322
91614065|NCT00431847|183121861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1166|STANDARD_ERROR_OF_MEAN|9.2462||0.0233|TWO_SIDED|95.0|2.8992|39.3341|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||39.3341|2.8992|0.0233
91655041|NCT00520741|183202799|SUPERIORITY_OR_OTHER||predicted exit rate at 112 days|0.323|||||TWO_SIDED|95.0|0.268|0.378|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.378|0.268|
91710852|NCT01408901|183314078|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.44|TWO_SIDED|95.0|-2.1|0.9||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.9|-2.1|0.44
91614066|NCT00339183|183121862|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.91||||0.0036|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.0036
91710853|NCT01408901|183314078|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.01|TWO_SIDED|95.0|2.2|5.2||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.2|2.2|<0.01
91710854|NCT01408901|183314079|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
91655042|NCT03702621|183202803|OTHER|P values are from mixed model least squares (LS) means differences with Sidak adjustment for multiple comparisons.||||||0.54|||||||Mixed Models Analysis|Sidak adjustment||||||0.54
91655043|NCT03702621|183202804|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.59|||||||Mixed Models Analysis|||||||0.59
91655044|NCT03702621|183202805|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.98||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.98
91655045|NCT03702621|183202806|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.94||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.94
91655046|NCT03702621|183202807|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.86|||||||Mixed Models Analysis|Sidak adjustment||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||0.86
91655047|NCT03702621|183202808|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||1||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||1.0
91655048|NCT03702621|183202809|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
91655049|NCT03702621|183202810|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
91655050|NCT03702621|183202811|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.72|||||||Mixed Models Analysis|||||||0.72
91655051|NCT03702621|183202812|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.29|||||||Mixed Models Analysis|||||||0.29
91655052|NCT03702621|183202813|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.46|||||||Mixed Models Analysis|||||||0.46
91655053|NCT03702621|183202814|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.77|||||||Mixed Models Analysis|||||||0.77
91655054|NCT01024738|183202885|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91655055|NCT02684578|183202886|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects regression|||||||0.39
91655056|NCT02684578|183202887|SUPERIORITY|||||||0.97||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.97
91655057|NCT02684578|183202888|SUPERIORITY|||||||0.12||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.12
91655058|NCT00626925|183202922|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91655059|NCT00626925|183202923|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91655060|NCT00626925|183202925|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91655061|NCT00626925|183202926|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
91655062|NCT00626925|183202927|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91655063|NCT00626925|183202928|SUPERIORITY_OR_OTHER|||||||0.06|||||||Mixed Models Analysis|||||||0.06
91655064|NCT00626925|183202929|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91655065|NCT01966042|183202930|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman test (n=13)|||||||< 0.001
91655066|NCT00625807|183202935|OTHER||||||>|0.1||||||Cohen's d = 0.5|ANOVA|||ANOVA for group by time interaction||||> 0.1
91655067|NCT00625807|183202936|OTHER|||||||0.103|||||||ANOVA|||||||0.103
91655068|NCT00625807|183202937|OTHER|||||||0.022|||||||t-test, 2 sided|||within group change pre to week 8||||.022
91655069|NCT00625807|183202937|OTHER|within group change from pre to week 8|||||<|0.001|||||||t-test, 2 sided|||||||<.001
91655070|NCT00625807|183202938|OTHER|||||||0.015|||||||t-test, 2 sided|||within group change from pre to week 8||||.015
91655071|NCT00625807|183202938|OTHER|||||||0.53|||||||t-test, 2 sided|||within group change from pre to week 8||||.53
91655072|NCT00625807|183202939|OTHER|||||||0.06|||||||t-test, 2 sided|||within group change from pre to week 8||||.06
91655073|NCT00625807|183202939|OTHER||||||<|0.001|||||||t-test, 2 sided|||within group change from pre to post||||<.001
91655074|NCT03267264|183202940|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.5|||||TWO_SIDED|95.0|10.3|24.7||||||||24.7|10.3|
91655075|NCT03267264|183202941|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.5|||||TWO_SIDED|95.0|16.8|44.3||||||||44.3|16.8|
91655076|NCT03267264|183202941|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall|20.6|||||TWO_SIDED|95.0|4.1|37.1||||||||37.1|4.1|
91614067|NCT00339183|183121862|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.46||||0.1448|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.1448
91614068|NCT00339183|183121863|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.57||||0.1154|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.1154
91614069|NCT00339183|183121863|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-0.6||||0.5503|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.||||0.5503
91614070|NCT00339183|183121864|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|3.21|8.6|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||8.60|3.21|<0.0001
91614071|NCT00339183|183121864|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.76|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||1.76|0.56|1.0000
91614072|NCT00076219|183121876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.12||0.47|TWO_SIDED|95.0|0.86|1.4|||Regression, Logistic|||||1.40|0.86|0.47
91655077|NCT03267264|183202941|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|overal mean|6.2|||||TWO_SIDED|95.0|-7.2|19.5||||||||19.5|-7.2|
91655078|NCT03267264|183202941|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.8|||||TWO_SIDED|95.0|-1.1|26.7||||||||26.7|-1.1|
91527383|NCT00453479|182929963|SUPERIORITY_OR_OTHER||Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.2482|||TWO_SIDED|90.0|0.77|1.838|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.838|0.770|
91614073|NCT02142894|183121885|EQUIVALENCE|The results are analyzed in a 2x2 contingency table with 95%CI.|2 x 2 contingency table|87.9|||||TWO_SIDED|95.0|72.7|95.2||||||||95.2|72.7|
91614074|NCT01455428|183121907|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.188||0.0002|TWO_SIDED|95.0|-1.08|-0.34||Primary analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.34|-1.08|0.0002
91710855|NCT01408901|183314080|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.03|TWO_SIDED|95.0|-0.01|-0.001|||t-test, 2 sided|||||-0.001|-0.010|0.03
91614075|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.149||0.001|TWO_SIDED|95.0|-0.79|-0.2||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.20|-0.79|0.0010
91614076|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.35|-0.94|<0.0001
91614077|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.151||0.0001|TWO_SIDED|95.0|-0.88|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.88|0.0001
91710856|NCT01408901|183314081|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
91710857|NCT01408901|183314082|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.17|TWO_SIDED|95.0|-0.009|0.002|||t-test, 2 sided|||||0.002|-0.009|0.17
91655079|NCT03267264|183202942|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall mean|18.0|||||TWO_SIDED|95.0|11.3|24.7||||||Overall Comfort||24.7|11.3|
91655080|NCT03267264|183202942|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.9|||||TWO_SIDED|95.0|9.9|21.8||||||Anxiety Associated with a Needle Stick Injury||21.8|9.9|
91655081|NCT03267264|183202942|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.5|||||TWO_SIDED|95.0|8.9|22.1||||||Injection Pain||22.1|8.9|
91655082|NCT03267264|183202942|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.7|||||TWO_SIDED|95.0|13.8|25.7||||||Ease of Use||25.7|13.8|
91655083|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|27.8|||||TWO_SIDED|95.0|14.9|40.7||||||Overall Comfort||40.7|14.9|
91655084|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|8.9|31.6||||||Anxiety Associated with a needle stick injury||31.6|8.9|
91655085|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|16.1|||||TWO_SIDED|95.0|3.4|28.8||||||Injection Pain||28.8|3.4|
91655086|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.7|||||TWO_SIDED|95.0|19.3|42.1||||||Ease of Use||42.1|19.3|
91655087|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.7|||||TWO_SIDED|95.0|5.3|36.1||||||Overall Comfort||36.1|5.3|
91655088|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.4|||||TWO_SIDED|95.0|6.0|32.8||||||Anxiety Associated with a needle stick||32.8|6|
91655089|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.6|||||TWO_SIDED|95.0|3.6|33.7||||||Injection Pain||33.7|3.6|
91710858|NCT02098395|183314097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.2|||Mixed Models Analysis|||Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.||-0.2|-0.5|< 0.0001
91710859|NCT02098395|183314097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||=|0.0021|TWO_SIDED|95.0|-0.38|-0.08|||Mixed Models Analysis|||Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.||-0.08|-0.38|= 0.0021
91722408|NCT00689936|183337135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.31274|TWO_SIDED|95.0|0.78|2.43|||Fisher Exact|||||2.43|0.78|0.31274
91710860|NCT02098395|183314097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||=|0.0011|TWO_SIDED|95.0|-0.39|-0.1|||Mixed Models Analysis|||Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.||-0.1|-0.39|= 0.0011
91710861|NCT01509612|183314138|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||0.397
91710862|NCT01509612|183314139|SUPERIORITY|||||||0.02|||||||Chi-squared|||Only those groups were compared who received an intervention||||0.02
91710863|NCT01765569|183314179|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.82|||||TWO_SIDED|90.0|1.63|2.02||||||||2.02|1.63|
91527384|NCT00453479|182929963|SUPERIORITY_OR_OTHER||Ratio|0.979|STANDARD_ERROR_OF_MEAN|0.2269|||TWO_SIDED|90.0|0.658|1.457|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.457|0.658|
91527385|NCT00453479|182929963|SUPERIORITY_OR_OTHER||Ratio|1.028|STANDARD_ERROR_OF_MEAN|0.2407|||TWO_SIDED|90.0|0.674|1.568|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.568|0.674|
91614078|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.152||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
91614079|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
91614080|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.153||0.0001|TWO_SIDED|95.0|-0.89|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.89|0.0001
91614081|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.01|-0.41||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.41|-1.01|<0.0001
91614082|NCT01455428|183121908|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.40|-1.00|<0.0001
91614083|NCT01455428|183121910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.2||0.0079|TWO_SIDED|95.0|-0.93|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.14|-0.93|0.0079
91614084|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.172||0.0024|TWO_SIDED|95.0|-0.86|-0.19||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.19|-0.86|0.0024
91614085|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.173||0.0002|TWO_SIDED|95.0|-0.99|-0.31||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.31|-0.99|0.0002
91710864|NCT01765569|183314183|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.47|||||TWO_SIDED|90.0|1.3|1.65||||||||1.65|1.3|
91710865|NCT05415462|183314193|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|97.5|0.952|1.071||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||1.071|0.952|
91710866|NCT05415462|183314193|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|GMR|1.657|||||TWO_SIDED|97.5|1.562|1.757||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||1.757|1.562|
91614086|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.173||0.0012|TWO_SIDED|95.0|-0.91|-0.22||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.22|-0.91|0.0012
91614087|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0101|TWO_SIDED|95.0|-0.79|-0.11||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.11|-0.79|0.0101
91614088|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0258|TWO_SIDED|95.0|-0.73|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.73|0.0258
91614089|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.026|TWO_SIDED|95.0|-0.74|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.74|0.0260
91614090|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.175||0.0062|TWO_SIDED|95.0|-0.83|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.14|-0.83|0.0062
91614091|NCT01455428|183121911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.176||0.0081|TWO_SIDED|95.0|-0.81|-0.12||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.12|-0.81|0.0081
91614092|NCT01455428|183121912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||Analysis was two-sided and performed at the 0.05 significance level|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||0.0007
91614093|NCT01455428|183121915|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|1.932|<|0.0001|TWO_SIDED|95.0|-11.99|-4.37||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-4.37|-11.99|<0.0001
91655090|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.4|||||TWO_SIDED|95.0|4.9|31.9||||||Ease of Use||31.9|4.9|
91655091|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|8.4|||||TWO_SIDED|95.0|-4.0|20.9||||||Overall Comfort||20.9|-4.0|
91710867|NCT05415462|183314193|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|GMR|0.665|||||TWO_SIDED|97.5|0.63|0.702||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Victoria Lineage||0.702|0.630|
91614094|NCT01455428|183121916|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.107||0.0007|TWO_SIDED|95.0|-0.58|-0.16||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.16|-0.58|0.0007
91614095|NCT01455428|183121918|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|2.464||0.0039|TWO_SIDED|95.0|-12.08|-2.35||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-2.35|-12.08|0.0039
91614096|NCT01455428|183121919|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.783||0.5351|TWO_SIDED|95.0|-3.76|7.22||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||7.22|-3.76|0.5351
91614097|NCT01455428|183121920|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|2.579||0.8892|TWO_SIDED|95.0|-5.45|4.73||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||4.73|-5.45|0.8892
91614098|NCT01455428|183121921|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.147||0.0035|TWO_SIDED|95.0|0.14|0.72||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.72|0.14|0.0035
91614099|NCT01455428|183121922|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.0972|TWO_SIDED|95.0|0.9|3.6||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||3.60|0.90|0.0972
91527386|NCT00453479|182929965|SUPERIORITY_OR_OTHER||Ratio|2.556|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|2.033|3.213|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||3.213|2.033|
91722409|NCT00689936|183337135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.01936|TWO_SIDED|95.0|1.13|3.19|||Fisher Exact|||||3.19|1.13|0.01936
91655092|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.9|||||TWO_SIDED|95.0|1.9|23.8||||||Anxiety Associated with a Needle stick injury||23.8|1.9|
91655093|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|7.0|||||TWO_SIDED|95.0|-5.3|19.4||||||Injection Pain||19.4|-5.3|
91655094|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.7|||||TWO_SIDED|95.0|6.7|28.8||||||Ease of Use||28.8|6.7|
91655095|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.1|||||TWO_SIDED|95.0|2.1|28.1||||||Overall Comfort||28.1|2.1|
91655096|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|11.0|||||TWO_SIDED|95.0|-0.5|22.4||||||Anxiety Associated with a Needle Stick Injury||22.4|-0.5|
91655097|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|7.4|33.1||||||Injection Pain||33.1|7.4|
91655098|NCT03267264|183202943|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.0|||||TWO_SIDED|95.0|0.5|23.5||||||Eae of Use||23.5|0.5|
91655099|NCT00266409|183202946|SUPERIORITY_OR_OTHER|||||||0.1143||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.1143
91655100|NCT00266409|183202946|SUPERIORITY_OR_OTHER|||||||0.4544||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.4544
91655101|NCT00266409|183202947|SUPERIORITY_OR_OTHER|||||||0.0173||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0173
91655102|NCT00266409|183202947|SUPERIORITY_OR_OTHER|||||||0.0516||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0516
91655103|NCT00266409|183202948|SUPERIORITY_OR_OTHER|||||||0.0361||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0361
91655104|NCT00266409|183202948|SUPERIORITY_OR_OTHER|||||||0.0366||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0366
91655105|NCT00266409|183202949|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7390
91655106|NCT00266409|183202949|SUPERIORITY_OR_OTHER|||||||0.6735||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.6735
91655107|NCT00266409|183202950|SUPERIORITY_OR_OTHER|||||||0.4261||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4261
91655108|NCT00266409|183202950|SUPERIORITY_OR_OTHER|||||||0.0231||95.0||||P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate|ANCOVA|||||||0.0231
91655109|NCT00266409|183202951|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate|ANCOVA|||||||0.1820
91527387|NCT00453479|182929965|SUPERIORITY_OR_OTHER||Ratio|1.644|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|90.0|1.29|2.095|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||2.095|1.290|
91527388|NCT03029780|182929968|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|-12.3|12.3||||||||12.3|-12.3|
91655110|NCT00266409|183202951|SUPERIORITY_OR_OTHER|||||||0.2187||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate|ANCOVA|||||||0.2187
91655111|NCT00266409|183202952|SUPERIORITY_OR_OTHER|||||||0.1456||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1456
91655112|NCT00266409|183202952|SUPERIORITY_OR_OTHER|||||||0.3618||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3618
91655113|NCT00266409|183202953|SUPERIORITY_OR_OTHER|||||||0.3535||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3535
91655114|NCT00266409|183202953|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.5660
91655115|NCT00266409|183202954|SUPERIORITY_OR_OTHER|||||||0.3414||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3414
91655116|NCT00266409|183202954|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7344
91655117|NCT00266409|183202955|SUPERIORITY_OR_OTHER|||||||0.1197||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1197
91655118|NCT00266409|183202955|SUPERIORITY_OR_OTHER|||||||0.4416||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4416
91655119|NCT00266409|183202956|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0350
91655120|NCT00266409|183202956|SUPERIORITY_OR_OTHER|||||||0.4205||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.4205
91655121|NCT00266409|183202957|SUPERIORITY_OR_OTHER|||||||0.2645||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.2645
91655122|NCT00266409|183202957|SUPERIORITY_OR_OTHER|||||||0.5369||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5369
91655123|NCT00266409|183202958|SUPERIORITY_OR_OTHER|||||||0.9988||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9988
91655124|NCT00266409|183202958|SUPERIORITY_OR_OTHER|||||||0.7729||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7729
91655125|NCT00266409|183202959|SUPERIORITY_OR_OTHER|||||||0.7338||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7338
91655126|NCT00266409|183202959|SUPERIORITY_OR_OTHER|||||||0.0897||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0897
91655127|NCT00266409|183202960|SUPERIORITY_OR_OTHER|||||||0.6501||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6501
91655128|NCT00266409|183202960|SUPERIORITY_OR_OTHER|||||||0.8196||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8196
91655129|NCT00266409|183202961|SUPERIORITY_OR_OTHER|||||||0.6404||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6404
91655130|NCT00266409|183202961|SUPERIORITY_OR_OTHER|||||||0.8263||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8263
91655131|NCT00266409|183202962|SUPERIORITY_OR_OTHER|||||||0.6946||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6946
91655132|NCT00266409|183202962|SUPERIORITY_OR_OTHER|||||||0.9629||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9629
91655133|NCT00266409|183202963|SUPERIORITY_OR_OTHER|||||||0.8617||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8617
91655134|NCT00266409|183202963|SUPERIORITY_OR_OTHER|||||||0.7555||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7555
91655135|NCT00266409|183202964|SUPERIORITY_OR_OTHER|||||||0.5836||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5836
91655136|NCT00266409|183202964|SUPERIORITY_OR_OTHER|||||||0.9096||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9096
91655137|NCT00266409|183202965|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0002
91655138|NCT00266409|183202965|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0006
91655139|NCT00266409|183202966|SUPERIORITY_OR_OTHER|||||||0.0255||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0255
91655140|NCT00266409|183202966|SUPERIORITY_OR_OTHER|||||||0.0065||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0065
91655141|NCT00266409|183202967|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0370
91710868|NCT05415462|183314193|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|GMR|0.661|||||TWO_SIDED|97.5|0.63|0.693||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Yamagata Lineage||0.693|0.630|
91655142|NCT00266409|183202967|SUPERIORITY_OR_OTHER|||||||0.9569||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.9569
91655143|NCT00266409|183202968|SUPERIORITY_OR_OTHER|||||||0.0978||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0978
91655144|NCT00266409|183202968|SUPERIORITY_OR_OTHER|||||||0.7096||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.7096
91655145|NCT00266409|183202969|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0001
91655146|NCT00266409|183202969|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0003
91655147|NCT00266409|183202970|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0025
91655148|NCT00266409|183202970|SUPERIORITY_OR_OTHER|||||||0.0101||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0101
91655149|NCT00266409|183202971|SUPERIORITY_OR_OTHER|||||||0.0095||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0095
91527389|NCT03029780|182929968|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.30|
91655150|NCT00266409|183202971|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0390
91655151|NCT00266409|183202972|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0160
91655152|NCT00266409|183202972|SUPERIORITY_OR_OTHER|||||||0.1024||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1024
91655153|NCT00266409|183202973|SUPERIORITY_OR_OTHER|||||||0.0761||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0761
91655154|NCT00266409|183202973|SUPERIORITY_OR_OTHER|||||||0.0376||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0376
91527390|NCT03029780|182929969|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
91710869|NCT05415462|183314194|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Percentage Difference|5.75|||||TWO_SIDED|97.5|3.12|8.38||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||8.38|3.12|
91527391|NCT03029780|182929970|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|5.8|||||TWO_SIDED|95.0|-13.3|24.8||||||||24.8|-13.3|
91527392|NCT03029780|182929970|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.58|2.78|||Cochran-Mantel-Haenszel|||||2.78|0.58|
91527393|NCT03029780|182929971|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|7.7|||||TWO_SIDED|95.0|-10.1|25.5||||||||25.5|-10.1|
91655155|NCT00266409|183202974|SUPERIORITY_OR_OTHER|||||||0.1196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1196
91710870|NCT05415462|183314194|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|Percentage Difference|16.91|||||TWO_SIDED|97.5|14.27|19.54||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||19.54|14.27|
91710871|NCT05415462|183314194|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-17.34|||||TWO_SIDED|97.5|-20.22|-14.43||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Victoria Lineage||-14.43|-20.22|
91710872|NCT05415462|183314194|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-15.68|||||TWO_SIDED|97.5|-18.57|-12.76||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Yamagata Lineage||-12.76|-18.57|
91710873|NCT00423813|183314227|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Overall Comparison||||0.001
91655156|NCT00266409|183202974|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0029
91655157|NCT00266409|183202975|SUPERIORITY_OR_OTHER|||||||0.6323||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.6323
91527394|NCT03029780|182929971|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.62|3.24|||Cochran-Mantel-Haenszel|||||3.24|0.62|
91710874|NCT00423813|183314227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 4.5g and placebo||||<0.001
91710875|NCT00423813|183314227|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 6.0g and placebo||||0.001
91710876|NCT01904032|183314236|SUPERIORITY||Mean Difference (Final Values)|0.7982|STANDARD_ERROR_OF_MEAN|2.0537||0.6982|TWO_SIDED|95.0|-3.2691|4.8656|||t-test, 2 sided|||The null hypothesis is that there is no difference in the CES-D change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||4.8656|-3.2691|.6982
91710877|NCT01904032|183314237|SUPERIORITY||Mean Difference (Final Values)|-0.0424|STANDARD_ERROR_OF_MEAN|3.6619||0.9908|TWO_SIDED|95.0|-7.2946|7.2097|||t-test, 2 sided|||The null hypothesis is that there is no difference in the PAID change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||7.2097|-7.2946|.9908
91710878|NCT01904032|183314238|SUPERIORITY||Mean Difference (Final Values)|0.4966|STANDARD_ERROR_OF_MEAN|3.1474||0.8749|TWO_SIDED|95.0|-5.7366|6.7298|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in systolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||6.7298|-5.7366|.8749
91710879|NCT01904032|183314239|SUPERIORITY||Mean Difference (Final Values)|1.5125|STANDARD_ERROR_OF_MEAN|1.8636||0.4187|TWO_SIDED|95.0|-2.1784|5.2033|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in diastolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||5.2033|-2.1784|.4187
91710880|NCT02373137|183314263|SUPERIORITY||Coefficient|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-1.0|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity.|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.|||-1.0|-2.8|<0.001
91722410|NCT00689936|183337136|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.82128|TWO_SIDED|95.0|0.46|2.8|||Fisher Exact|||||2.80|0.46|0.82128
91710881|NCT02373137|183314264|SUPERIORITY||Coefficient|-1.5||||0.002|TWO_SIDED|95.0|-2.5|-0.6|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.|Comparison of 3-Month Visual Acuity Between Groups||-0.6|-2.5|0.002
91722411|NCT00689936|183337136|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.11041|TWO_SIDED|95.0|0.19|1.14|||Fisher Exact|||||1.14|0.19|0.11041
91655158|NCT00266409|183202975|SUPERIORITY_OR_OTHER|||||||0.5533||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.5533
91655159|NCT00266409|183202976|SUPERIORITY_OR_OTHER|||||||0.1705||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1705
91655160|NCT00266409|183202976|SUPERIORITY_OR_OTHER|||||||0.3196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.3196
91655161|NCT00266409|183202977|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0419
91655162|NCT00266409|183202977|SUPERIORITY_OR_OTHER|||||||0.2541||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.2541
91655163|NCT00266409|183202978|SUPERIORITY_OR_OTHER|||||||0.0677||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0677
91655164|NCT00266409|183202978|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0273
91655165|NCT00266409|183202979|SUPERIORITY_OR_OTHER|||||||0.5153||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5153
91655166|NCT00266409|183202979|SUPERIORITY_OR_OTHER|||||||0.0122||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0122
91655167|NCT00266409|183202980|SUPERIORITY_OR_OTHER|||||||0.4648||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4648
91655168|NCT00266409|183202980|SUPERIORITY_OR_OTHER|||||||0.5502||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5502
91655169|NCT00266409|183202981|SUPERIORITY_OR_OTHER|||||||0.9093||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.9093
91655170|NCT00266409|183202981|SUPERIORITY_OR_OTHER|||||||0.1354||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1354
91655171|NCT00266409|183202982|SUPERIORITY_OR_OTHER|||||||0.7434||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.7434
91655172|NCT00266409|183202982|SUPERIORITY_OR_OTHER|||||||0.1148||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1148
91655173|NCT00266409|183202983|SUPERIORITY_OR_OTHER|||||||0.9346||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate|ANCOVA|||||||0.9346
91655174|NCT00266409|183202983|SUPERIORITY_OR_OTHER|||||||0.2709||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2709
91655175|NCT00266409|183202984|SUPERIORITY_OR_OTHER|||||||0.3827||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3827
91655176|NCT00266409|183202984|SUPERIORITY_OR_OTHER|||||||0.2513||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2513
91655177|NCT00266409|183202985|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3930
91655178|NCT00266409|183202985|SUPERIORITY_OR_OTHER|||||||0.5461||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5461
91655179|NCT00266409|183202986|SUPERIORITY_OR_OTHER|||||||0.0722||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0722
91655180|NCT00266409|183202986|SUPERIORITY_OR_OTHER|||||||0.4639||95.0||||P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4639
91655181|NCT00266409|183202987|SUPERIORITY_OR_OTHER|||||||0.0075||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0075
91710882|NCT02373137|183314264|SUPERIORITY||Coefficient|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.|Comparison of 12 Month Visual Acuity Between Groups||-0.7|-2.2|<0.001
91710883|NCT02373137|183314266|SUPERIORITY||Coefficient|-77.0||||0.53|TWO_SIDED|95.0|-326.0|172.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 3 months.|||172|-326|0.53
91710884|NCT02373137|183314266|SUPERIORITY||Coefficient|-150.0||||0.17|TWO_SIDED|95.0|-356.0|66.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 6 months.|||66|-356|0.17
91710885|NCT02373137|183314266|SUPERIORITY||Coefficient|-215.0||||0.051|TWO_SIDED|95.0|-430.0|-0.4|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 12 months.|||-0.4|-430|0.051
91710886|NCT02373137|183314272|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
91710887|NCT02559570|183314314|SUPERIORITY||Least Squares Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.149||0.7789|TWO_SIDED|95.0|-0.335|0.252|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.252|-0.335|0.7789
91710888|NCT02559570|183314314|SUPERIORITY||Least Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.143||0.993|TWO_SIDED|95.0|-0.282|0.284|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.284|-0.282|0.9930
91614100|NCT01455428|183121923|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|3.161||0.5702|TWO_SIDED|95.0|-4.44|8.03||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||8.03|-4.44|0.5702
91614101|NCT01455428|183121924|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|2.194||0.6929|TWO_SIDED|95.0|-3.46|5.2||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||5.20|-3.46|0.6929
91614102|NCT01455428|183121925|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.84|STANDARD_ERROR_OF_MEAN|1.92||0.1403|TWO_SIDED|95.0|-6.63|0.94||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.94|-6.63|0.1403
91614103|NCT01455428|183121926|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.86|-0.39||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.39|-0.86|<0.0001
91614104|NCT01455428|183121927|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-0.72|-0.27||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.27|-0.72|<0.0001
91710889|NCT02559570|183314314|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.146||0.4107|TWO_SIDED|95.0|-0.167|0.408|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.408|-0.167|0.4107
91710890|NCT02559570|183314315|SUPERIORITY||Least Squares Mean Difference|-0.588|STANDARD_ERROR_OF_MEAN|0.577||0.3097|TWO_SIDED|95.0|-1.729|0.552|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.552|-1.729|0.3097
91710891|NCT02559570|183314315|SUPERIORITY||Least Squares Mean Difference|-0.186|STANDARD_ERROR_OF_MEAN|0.557||0.7384|TWO_SIDED|95.0|-1.286|0.913|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.913|-1.286|0.7384
91710892|NCT02559570|183314315|SUPERIORITY||Least Squares Mean Difference|0.364|STANDARD_ERROR_OF_MEAN|0.563||0.5188|TWO_SIDED|95.0|-0.748|1.477|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||1.477|-0.748|0.5188
91710893|NCT02559570|183314316|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.249||0.8426|TWO_SIDED|95.0|-0.543|0.444|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.444|-0.543|0.8426
91710894|NCT02559570|183314316|SUPERIORITY||Least Squares Mean Difference|-0.038|STANDARD_ERROR_OF_MEAN|0.246||0.877|TWO_SIDED|95.0|-0.525|0.448|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.448|-0.525|0.8770
91710895|NCT02559570|183314316|SUPERIORITY||Least Squares Mean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.246||0.1502|TWO_SIDED|95.0|-0.131|0.842|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.842|-0.131|0.1502
91722412|NCT00689936|183337136|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.44||||0.07302|TWO_SIDED|95.0|1.01|5.91|||Fisher Exact|||||5.91|1.01|0.07302
91655182|NCT00266409|183202987|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate|ANCOVA|||||||0.1641
91655183|NCT00266409|183202988|SUPERIORITY_OR_OTHER|||||||0.0932||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0932
91655184|NCT00266409|183202988|SUPERIORITY_OR_OTHER|||||||0.0852||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0852
91655185|NCT00266409|183202989|SUPERIORITY_OR_OTHER|||||||0.7896||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.7896
91655186|NCT00266409|183202989|SUPERIORITY_OR_OTHER|||||||0.9651||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9651
91655187|NCT00266409|183202990|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8280
91655188|NCT00266409|183202990|SUPERIORITY_OR_OTHER|||||||0.0936||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0936
91655189|NCT00266409|183202991|SUPERIORITY_OR_OTHER|||||||0.3539||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3539
91655190|NCT00266409|183202991|SUPERIORITY_OR_OTHER|||||||0.4672||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.4672
91655191|NCT00266409|183202992|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.2550
91655192|NCT00266409|183202992|SUPERIORITY_OR_OTHER|||||||0.3125||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3125
91655193|NCT00266409|183202993|SUPERIORITY_OR_OTHER|||||||0.3174||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3174
91655194|NCT00266409|183202993|SUPERIORITY_OR_OTHER|||||||0.9427||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9427
91655195|NCT00266409|183202994|SUPERIORITY_OR_OTHER|||||||0.3252||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3252
91655196|NCT00266409|183202994|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.6090
91655197|NCT00266409|183202995|SUPERIORITY_OR_OTHER|||||||0.1247||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1247
91655198|NCT00266409|183202995|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8430
91655199|NCT00266409|183202996|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1031
91655200|NCT00266409|183202996|SUPERIORITY_OR_OTHER|||||||0.0543||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0543
91655201|NCT00266409|183202997|SUPERIORITY_OR_OTHER|||||||0.0508||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0508
91655202|NCT00266409|183202997|SUPERIORITY_OR_OTHER|||||||0.0871||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0871
91655203|NCT00266409|183202998|SUPERIORITY_OR_OTHER|||||||0.8318||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.8318
91655204|NCT00266409|183202998|SUPERIORITY_OR_OTHER|||||||0.5375||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.5375
91655205|NCT00266409|183202999|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2186
91655206|NCT00266409|183202999|SUPERIORITY_OR_OTHER|||||||0.0422||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0422
91655207|NCT00266409|183203000|SUPERIORITY_OR_OTHER|||||||0.1164||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1164
91655208|NCT00266409|183203000|SUPERIORITY_OR_OTHER|||||||0.1935||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1935
91655209|NCT00266409|183203001|SUPERIORITY_OR_OTHER|||||||0.1244||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1244
91655210|NCT00266409|183203001|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.6182
91655211|NCT00266409|183203002|SUPERIORITY_OR_OTHER|||||||0.4589||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4589
91655212|NCT00266409|183203002|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.3930
91655213|NCT00266409|183203003|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4450
91655214|NCT00266409|183203003|SUPERIORITY_OR_OTHER|||||||0.2924||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2924
91655215|NCT00266409|183203004|SUPERIORITY_OR_OTHER|||||||0.2184||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2184
91710896|NCT02559570|183314316|SUPERIORITY||Least Squares Mean Difference|-0.062|STANDARD_ERROR_OF_MEAN|0.239||0.7949|TWO_SIDED|95.0|-0.535|0.41|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.410|-0.535|0.7949
91655216|NCT00266409|183203004|SUPERIORITY_OR_OTHER|||||||0.1281||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1281
91655217|NCT00266409|183203005|SUPERIORITY_OR_OTHER|||||||0.6602||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.6602
91655218|NCT00266409|183203006|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5544
91655219|NCT00266409|183203007|SUPERIORITY_OR_OTHER|||||||0.9269||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9269
91655220|NCT00266409|183203008|SUPERIORITY_OR_OTHER|||||||0.5271||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5271
91655221|NCT00266409|183203009|SUPERIORITY_OR_OTHER|||||||0.1447||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.1447
91655222|NCT00266409|183203010|SUPERIORITY_OR_OTHER|||||||0.9375||95.0||||P-value from a Chi-squared test|Chi-squared|||||||0.9375
91655223|NCT00266409|183203011|SUPERIORITY_OR_OTHER|||||||0.9883||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9883
91655224|NCT00266409|183203012|SUPERIORITY_OR_OTHER|||||||0.3093||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.3093
91710897|NCT02559570|183314316|SUPERIORITY||Least Squares Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.235||0.7543|TWO_SIDED|95.0|-0.54|0.392|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.392|-0.540|0.7543
91655225|NCT00266409|183203013|SUPERIORITY_OR_OTHER|||||||0.5824||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5824
91655226|NCT00266409|183203014|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.044
91655227|NCT00266409|183203014|SUPERIORITY_OR_OTHER|||||||0.6587||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.6587
91655228|NCT00108732|183203022|SUPERIORITY_OR_OTHER||Percent|62.5|||||TWO_SIDED|90.0|48.3|75.3||||||||75.3|48.3|
91655229|NCT00108732|183203023|SUPERIORITY_OR_OTHER||Response rate (percent)|0.0|||||TWO_SIDED|90.0|0.0|7.2||||||||7.2|0|
91655230|NCT00108732|183203024|SUPERIORITY_OR_OTHER||median of difference|0.45||||0.003||95.0|||||Wilcoxon signed rank test|The Wilcoxon signed rank test was used to test the difference between day 4 PSA and day 15 PSA.||||||0.003
91655231|NCT00108732|183203025|SUPERIORITY_OR_OTHER||median of difference|-0.04||||0.02||95.0||||The Wilcoxon signed-rank test was used to test the difference between pre and post-treatment PSA slopes assessed by multiple PSA values on natural log scale using a piecewise linear model with a common knot point at the date of registration.|Wilcoxon signed rank test|||||||0.02
91655232|NCT01901055|183203031|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.18||0.017|TWO_SIDED|95.0|-0.68|0.04||F-test statistics for group X time = 4.27|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment.||0.04|-0.68|0.017
91655233|NCT01901055|183203032|SUPERIORITY||Mean Difference (Net)|-16.78|STANDARD_ERROR_OF_MEAN|10.99||0.307|TWO_SIDED|95.0|-38.66|5.09||F test statistics for group X time = 1.20|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||5.09|-38.66|0.307
91655234|NCT01901055|183203033|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.3||0.732|TWO_SIDED|95.0|-0.85|0.35||F test statistics for group X time = 0.31|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-0.85|0.732
91655235|NCT01901055|183203034|SUPERIORITY||Mean Difference (Net)|3.65|STANDARD_ERROR_OF_MEAN|2.65||0.919|TWO_SIDED|95.0|-1.62|8.92||F test statistics for group X time = 0.01|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||8.92|-1.62|0.919
91655236|NCT01901055|183203035|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.54||0.125|TWO_SIDED|95.0|-1.18|0.96||F-test statistics for group X time = 2.12|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.96|-1.18|0.125
91655237|NCT01901055|183203036|SUPERIORITY||Mean Difference (Net)|87.22|STANDARD_ERROR_OF_MEAN|529.1||0.639|TWO_SIDED|95.0|-936.1|1137.5||F-test statistics for group X time = 0.45|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1137.50|-936.10|0.639
91655238|NCT01901055|183203037|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.49||0.461|TWO_SIDED|95.0|-1.61|0.35||F-test statistics for group X time = 0.78|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-1.61|0.461
91655239|NCT01901055|183203038|SUPERIORITY||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|3.94||0.776|TWO_SIDED|95.0|-4.78|10.86||F-test statistics for group X time= 0.25|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||10.86|-4.78|0.776
91655240|NCT01901055|183203039|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.79||0.378|TWO_SIDED|95.0|-1.24|1.89||F-test statistics for group X time = 0.98|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.89|-1.24|0.378
91655241|NCT01901055|183203040|SUPERIORITY||Mean Difference (Net)|3.18|STANDARD_ERROR_OF_MEAN|7.24||0.213|TWO_SIDED|95.0|-11.19|17.56||F-test statistics for group X time = 1.57|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||17.56|-11.19|0.213
91722413|NCT00230737|183337179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3594.0|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91722414|NCT00848185|183337180|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||ANOVA for three groups||||<0.001
91655242|NCT01901055|183203041|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED|95.0|-1.27|1.28||F-test statistics for group X time = 5.66|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.28|-1.27|0.005
91655243|NCT01915732|183203082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.002|TWO_SIDED|95.0|-7.4|-1.6|||ANCOVA|||||-1.6|-7.4|0.002
91655244|NCT01915732|183203083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||ANCOVA|||||-1.9|-7.3|<0.001
91655245|NCT01915732|183203084|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
91655246|NCT01915732|183203085|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|||||||0.013
91655247|NCT01915732|183203086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.077|TWO_SIDED|95.0|-1.8|0.1|||ANCOVA||Statistical data for the category=IL.|||0.1|-1.8|0.077
91655248|NCT01915732|183203086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.004|TWO_SIDED|95.0|-5.7|-1.1|||ANCOVA||Statistical data for the category=NIL.|||-1.1|-5.7|0.004
91655249|NCT01915732|183203087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.028|TWO_SIDED|95.0|-2.0|-0.1|||ANCOVA||Statistical data for the category=IL.|||-0.1|-2.0|0.028
91655250|NCT01915732|183203087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.2|||ANCOVA||Statistical data for the category=NIL.|||-1.2|-5.5|0.002
91655251|NCT01915732|183203088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.08|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA||Statistical data for the category=IL.|||0.00|-0.06|0.080
91655252|NCT01915732|183203088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.004|TWO_SIDED|95.0|-0.12|-0.02|||ANCOVA||Statistical data for the category=NIL.|||-0.02|-0.12|0.004
91710898|NCT02559570|183314316|SUPERIORITY||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.235||0.2676|TWO_SIDED|95.0|-0.204|0.728|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.728|-0.204|0.2676
91527395|NCT01763788|182929982|SUPERIORITY||Stratified Hazard Ratio|0.656||||0.0161|TWO_SIDED|95.0|0.465|0.926|||Stratified Log Rank|||||0.926|0.465|0.0161
91655253|NCT01915732|183203088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.003|TWO_SIDED|95.0|-0.09|-0.02|||ANCOVA||Statisticial data for the category=Total.|||-0.02|-0.09|0.003
91655254|NCT01915732|183203089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.025|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA||Statistical data for the category=IL.|||-0.00|-0.07|0.025
91655255|NCT01915732|183203089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||Statistical data for the category=NIL.|||-0.04|-0.14|<0.001
91655256|NCT01915732|183203089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.03|||ANCOVA||Statistical data for the category=Total.|||-0.03|-0.10|<0.001
91655257|NCT01915732|183203090|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91655258|NCT01915732|183203091|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91655259|NCT00698685|183203092|SUPERIORITY_OR_OTHER||actuarial probability of engraftment|70.0||||||95.0|||||||Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.|||||
91655260|NCT01325207|183203094|OTHER||||||||||||||||||The Maximum Tolerated Dose (MTD) was determined to be 80mg IT every two weeks. This is based on no DLTs being seeing in Cohorts 1-4 with lower doses and 1 DLT out of 7 patients observed at 80mg IT in Cohort 5.|||
91655261|NCT00635154|183203129|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|1.8||||||95.0|0.5|10.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||10|0.5|
91655262|NCT03312257|183203137|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|0.03||||0.7|TWO_SIDED|95.0|-0.14|0.21|||Repeated measures analyses|||||0.21|-0.14|0.70
91655263|NCT03312257|183203138|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|-0.08||||0.054|TWO_SIDED|95.0|-0.16|0.002|||Repeated measures analyses|||||0.002|-0.16|0.054
91655264|NCT02660242|183203148|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.||The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose \<70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery \[prior to the meal\]), the nadir glucose value was carried forward through the end of early recovery.||||<0.001
91655265|NCT02660242|183203149|OTHER|||||||0.99|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.99
91655266|NCT02660242|183203150|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.15
91655267|NCT02660242|183203151|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.99
91655268|NCT02660242|183203152|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.43
91655269|NCT02660242|183203153|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.16
91655270|NCT02660242|183203154|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.69
91527396|NCT02006121|182930000|SUPERIORITY|||||||0.0047|||||||Mixed Models Analysis|||||||0.0047
91527397|NCT02006121|182930001|SUPERIORITY|||||||0.0022|||||||Mixed Models Analysis|||||||0.0022
91710899|NCT02559570|183314317|SUPERIORITY||Least Squares Mean Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.208||0.7997|TWO_SIDED|95.0|-0.465|0.359|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.359|-0.465|0.7997
91710900|NCT02559570|183314317|SUPERIORITY||Least Squares Mean Difference|-0.121|STANDARD_ERROR_OF_MEAN|0.207||0.5602|TWO_SIDED|95.0|-0.53|0.288|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.288|-0.530|0.5602
91710901|NCT02559570|183314317|SUPERIORITY||Least Squares Mean Difference|-0.236|STANDARD_ERROR_OF_MEAN|0.205||0.2529|TWO_SIDED|95.0|-0.641|0.17|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.170|-0.641|0.2529
91710902|NCT02559570|183314317|SUPERIORITY||Least Squares Mean Difference|-0.054|STANDARD_ERROR_OF_MEAN|0.206||0.7923|TWO_SIDED|95.0|-0.461|0.352|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.352|-0.461|0.7923
91710903|NCT02559570|183314317|SUPERIORITY||Least Squares Mean Difference|-0.113|STANDARD_ERROR_OF_MEAN|0.204||0.5802|TWO_SIDED|95.0|-0.517|0.29|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.290|-0.517|0.5802
91710904|NCT02559570|183314317|SUPERIORITY||Least Squares Mean Difference|-0.199|STANDARD_ERROR_OF_MEAN|0.202||0.3263|TWO_SIDED|95.0|-0.6|0.201|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.201|-0.600|0.3263
91710905|NCT02559570|183314318|SUPERIORITY||Least Squares Mean Difference|0.048|STANDARD_ERROR_OF_MEAN|0.152||0.7507|TWO_SIDED|95.0|-0.252|0.349|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.349|-0.252|0.7507
91710906|NCT02559570|183314318|SUPERIORITY||Least Squares Mean Difference|0.028|STANDARD_ERROR_OF_MEAN|0.146||0.8505|TWO_SIDED|95.0|-0.262|0.317|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.317|-0.262|0.8505
91710907|NCT02559570|183314318|SUPERIORITY||Least Squares Mean Difference|0.039|STANDARD_ERROR_OF_MEAN|0.149||0.7933|TWO_SIDED|95.0|-0.254|0.332|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.332|-0.254|0.7933
91614105|NCT01455428|183121929|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.315||0.506|TWO_SIDED|95.0|-0.83|0.41||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.41|-0.83|0.5060
91614106|NCT01455428|183121930|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.285||0.7247|TWO_SIDED|95.0|-0.66|0.46||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.46|-0.66|0.7247
91614107|NCT01276847|183121946|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.016
91527398|NCT02006121|182930002|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91527399|NCT02006121|182930003|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
91527400|NCT02006121|182930004|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91614108|NCT01276847|183121946|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.007
91614109|NCT01276847|183121946|SUPERIORITY_OR_OTHER|||||||0.00015||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.00015
91614110|NCT01276847|183121946|SUPERIORITY_OR_OTHER|||||||0.000184||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000184
91655271|NCT02660242|183203155|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.67
91614111|NCT01276847|183121947|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.397
91614112|NCT01276847|183121947|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.010
91710908|NCT02559570|183314319|SUPERIORITY||Least Squares Mean Difference|-0.425|STANDARD_ERROR_OF_MEAN|0.45||0.3461|TWO_SIDED|95.0|-1.313|0.463|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.463|-1.313|0.3461
91710909|NCT02559570|183314319|SUPERIORITY||Least Squares Mean Difference|-0.235|STANDARD_ERROR_OF_MEAN|0.435||0.5892|TWO_SIDED|95.0|-1.095|0.624|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.624|-1.095|0.5892
91710910|NCT02559570|183314319|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.856|TWO_SIDED|95.0|-0.789|0.949|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.949|-0.789|0.8560
91614113|NCT01276847|183121947|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.002
91655272|NCT02660242|183203156|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.84
91614114|NCT01276847|183121947|SUPERIORITY_OR_OTHER|||||||0.000215||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000215
91655273|NCT02660242|183203157|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.63
91655274|NCT02660242|183203158|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.24
91655275|NCT02660242|183203159|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.26
91655276|NCT00982553|183203160|SUPERIORITY||Geometric mean ratios|0.79|||||TWO_SIDED|95.0|0.62|1.0||||||||1.00|0.62|
91655277|NCT00982553|183203161|SUPERIORITY||Geometric mean ratios|1.16|||||TWO_SIDED|95.0|0.73|1.86||||||||1.86|0.73|
91710911|NCT01680653|183314335|SUPERIORITY_OR_OTHER|||||||0.106||||||In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P\<0.05.|Wilcoxon (Mann-Whitney)|||The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of \<70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for \> or = 25 minutes.||||0.106
91710912|NCT01680653|183314336|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.078
91710913|NCT01680653|183314337|SUPERIORITY_OR_OTHER||Fisher's exact test|||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is the P value for the number of events \<70 mg/dL longer than one hour||||0.003
91710914|NCT01680653|183314337|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events \<70 mg/dL that were greater than 2 hours||||0.010
91710915|NCT01680653|183314337|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events that were \<50 mg/dL for \> 30 minutes||||0.021
91710916|NCT01680653|183314337|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Fisher's exact|||This is the P value for the number of events \<50 mg/dL that were \>1 hr||||0.077
91710917|NCT03373461|183314338|OTHER|||||||0.038|||||||Multiple Comparison Procedure-Modeling|||||||0.038
91710918|NCT03373461|183314338|OTHER||Ratio to placebo (of ratio to baseline)|0.99|||||TWO_SIDED|80.0|0.86|1.0||||||||1.00|0.86|
91614115|NCT01276847|183121948|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.787
91710919|NCT03373461|183314338|OTHER||Ratio to placebo (of ratio to baseline)|0.94|||||TWO_SIDED|80.0|0.76|0.98||||||||0.98|0.76|
91710920|NCT03373461|183314338|OTHER||Ratio to placebo (of ratio to baseline)|0.87|||||TWO_SIDED|80.0|0.72|0.96||||||||0.96|0.72|
91710921|NCT03373461|183314338|OTHER||Ratio to placebo (of ratio to baseline)|0.77|||||TWO_SIDED|80.0|0.66|0.92||||||||0.92|0.66|
91710922|NCT03373461|183314339|OTHER||Mean Difference (Final Values)|3.28|||||TWO_SIDED|80.0|0.21|6.344||||||||6.344|0.210|
91710923|NCT03373461|183314339|OTHER||Mean Difference (Final Values)|5.83|||||TWO_SIDED|80.0|2.642|9.01||||||||9.010|2.642|
91710924|NCT03373461|183314339|OTHER||Mean Difference (Final Values)|3.56|||||TWO_SIDED|80.0|0.427|6.7||||||||6.700|0.427|
91710925|NCT03373461|183314339|OTHER||Mean Difference (Final Values)|5.76|||||TWO_SIDED|80.0|2.882|8.638||||||||8.638|2.882|
91710926|NCT03373461|183314340|OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|80.0|-15.253|-3.145||||||||-3.145|-15.253|
91710927|NCT03373461|183314340|OTHER||Mean Difference (Final Values)|-9.25|||||TWO_SIDED|80.0|-15.499|-3.0||||||||-3.000|-15.499|
91710928|NCT03373461|183314340|OTHER||Mean Difference (Final Values)|-5.89|||||TWO_SIDED|80.0|-12.04|0.26||||||||0.260|-12.040|
91710929|NCT03373461|183314340|OTHER||Mean Difference (Final Values)|-10.12|||||TWO_SIDED|80.0|-15.763|-4.471||||||||-4.471|-15.763|
91710930|NCT03373461|183314342|OTHER||Ratio to placebo (of ratio to baseline)|0.95|||||TWO_SIDED|80.0|0.742|1.222||||||||1.222|0.742|
91710931|NCT03373461|183314342|OTHER||Ratio to placebo (of ratio to baseline)|1.06|||||TWO_SIDED|80.0|0.83|1.356||||||||1.356|0.830|
91710932|NCT03373461|183314342|OTHER||Ratio to placebo (of ratio to baseline)|0.73|||||TWO_SIDED|80.0|0.569|0.928||||||||0.928|0.569|
91710933|NCT03373461|183314342|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.669|1.05||||||||1.050|0.669|
91710934|NCT03373461|183314343|OTHER||Ratio to placebo (of ratio to baseline)|0.96|||||TWO_SIDED|80.0|0.741|1.25||||||||1.250|0.741|
91710935|NCT03373461|183314343|OTHER||Ratio to placebo (of ratio to baseline)|1.13|||||TWO_SIDED|80.0|0.872|1.458||||||||1.458|0.872|
91710936|NCT03373461|183314343|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.574|0.957||||||||0.957|0.574|
91710937|NCT03373461|183314343|OTHER||Ratio to placebo (of ratio to baseline)|0.89|||||TWO_SIDED|80.0|0.706|1.132||||||||1.132|0.706|
91710938|NCT03373461|183314344|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.794|1.214||||||||1.214|0.794|
91710939|NCT03373461|183314344|OTHER||Ratio to placebo (of ratio to baseline)|1.03|||||TWO_SIDED|80.0|0.835|1.269||||||||1.269|0.835|
91710940|NCT03373461|183314344|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.616|0.942||||||||0.942|0.616|
91710941|NCT03373461|183314344|OTHER||Ratio to placebo (of ratio to baseline)|0.85|||||TWO_SIDED|80.0|0.704|1.027||||||||1.027|0.704|
91710942|NCT03373461|183314345|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.723|1.172||||||||1.172|0.723|
91710943|NCT03373461|183314345|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.767|1.249||||||||1.249|0.767|
91710944|NCT03373461|183314345|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.577|0.937||||||||0.937|0.577|
91710945|NCT03373461|183314345|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.678|1.052||||||||1.052|0.678|
91710946|NCT03373461|183314354|OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|80.0|0.42|7.472||||||||7.472|0.420|
91710947|NCT03373461|183314354|OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|80.0|-2.747|4.39||||||||4.390|-2.747|
91710948|NCT03373461|183314354|OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|80.0|-2.745|3.262||||||||3.262|-2.745|
91710949|NCT03373461|183314354|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|80.0|-1.368|5.337||||||||5.337|-1.368|
91710950|NCT03373461|183314355|OTHER||Ratio to placebo (of ratio to baseline)|1.04|||||TWO_SIDED|80.0|0.68|1.579||||||||1.579|0.680|
91710951|NCT03373461|183314355|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.607|1.39||||||||1.390|0.607|
91710952|NCT03373461|183314355|OTHER||Ratio to placebo (of ratio to baseline)|0.8|||||TWO_SIDED|80.0|0.558|1.153||||||||1.153|0.558|
91710953|NCT03373461|183314355|OTHER||Ratio to placebo (of ratio to baseline)|0.91|||||TWO_SIDED|80.0|0.614|1.362||||||||1.362|0.614|
91710954|NCT03373461|183314357|OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|80.0|0.792|1.692||||||||1.692|0.792|
91710955|NCT03373461|183314357|OTHER||Geometric mean ratio|0.65|||||TWO_SIDED|80.0|0.446|0.945||||||||0.945|0.446|
91710956|NCT03373461|183314357|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|80.0|0.518|0.997||||||||0.997|0.518|
91710957|NCT03373461|183314357|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.558|1.146||||||||1.146|0.558|
91527401|NCT02354859|182930005|SUPERIORITY||Difference in Proportions|5.9||||0.811|TWO_SIDED|95.0|-11.2|22.4|||Cochran-Mantel-Haenszel||The estimate is adjusted for baseline FEV1 % predicted strata (\<50% of predicted, between 50% and 70% of predicted, and \>70% of predicted).|||22.4|-11.2|0.811
91655278|NCT00982553|183203162|SUPERIORITY||Geometric mean ratios|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||||1.18|0.87|
91655279|NCT00982553|183203163|SUPERIORITY||Geometric mean ratios|0.82|||||TWO_SIDED|95.0|0.36|1.85||||||||1.85|0.36|
91655280|NCT04087395|183203164|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0001||||||One-sided paired student t-test|t-test, 1 sided|||||||<0.0001
91655281|NCT02796664|183203173|OTHER|Equality test||||||0.462|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and cerebral ischemic events including ischemic stroke and transient ischemic attack. The number of participants who suffered ischemic stroke and the number of paticipants who suffered transient ischemic attack were analyzed together to test the null hypothesis in two by two table.||||0.462
91655282|NCT02796664|183203174|OTHER|Equality test||||||0.34|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and modified Rankin Scale at follow-up.||||0.34
91655283|NCT02796664|183203175|OTHER|Equality test||||||0.13|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and flow change in steno-occlusive lesion.||||0.13
91655284|NCT02796664|183203175|OTHER|Equality test||||||0.17|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and flow change in collateral vessel.||||0.17
91655285|NCT02796664|183203176|OTHER|Equality test||||||0.74|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and periventricular white matter lesions at follow-up.||||0.74
91655286|NCT02796664|183203176|OTHER|Equality test||||||0.95|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and deep white matter lesions at follow-up.||||0.95
91655287|NCT02796664|183203177|OTHER|Equality test||||||0.23|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and parenchymal ischemic lesions at follow-up.||||0.23
91655288|NCT02796664|183203178|OTHER|Equality test||||||0.79|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no relationship between ginseng administration and drug compliance at follow-up.||||0.79
91655289|NCT01626079|183203185|NON_INFERIORITY|Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide \> 95% power to reject the null hypothesis at the one-sided significance level of 5%.|Kaplan Meier|0.966|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|ONE_SIDED|95.0|0.948||||Z test Using Kaplan Meier Survival|P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance|||||0.948|<0.0001
91655290|NCT01626079|183203218|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.02|TWO_SIDED|95.0|0.6|0.96|||Joint Fraility Model|||||0.96|0.60|<0.02
91655291|NCT01626079|183203219|SUPERIORITY||Win Ratio|1.61|||<|0.0001|TWO_SIDED|95.0|1.29|2.04|||Finkelstein-Schoenfeld Analysis|||||2.04|1.29|<0.0001
91655292|NCT02566135|183203543|OTHER||Risk Ratio (RR)|1.4628||||0.5033|TWO_SIDED|95.0|0.6401|3.3428|||Chi-squared, Corrected|||Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.||3.3428|0.6401|0.5033
91655293|NCT02566135|183203544|OTHER||Risk Ratio (RR)|0.8972|||>|0.05|TWO_SIDED|95.0|0.4858|1.6569|||Chi-squared, Corrected|||We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.||1.6569|0.4858|>0.05
91655294|NCT02566135|183203545|OTHER||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91655295|NCT02566135|183203546|OTHER|||||||0.44|||||||t-test, 2 sided|||Heart rate beats per minute measured at base line among the group I and group C.||||0.44
91655296|NCT02566135|183203546|OTHER|||||||0.58|||||||t-test, 2 sided|||Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.||||0.58
91655297|NCT02566135|183203546|OTHER|||||||0.16|||||||t-test, 2 sided|||Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.||||0.16
91655298|NCT02566135|183203546|OTHER|||||||0.22|||||||t-test, 2 sided|||Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.||||0.22
91655299|NCT02566135|183203546|OTHER|||||||0.059|||||||t-test, 2 sided|||Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.||||0.059
91655300|NCT02566135|183203546|OTHER||||||>|0.33|||||||t-test, 2 sided|||Heart rate beats per minute measured at endotracheal intubation among the group I and group C.||||>0.33
91655301|NCT02566135|183203546|OTHER|||||||0.63|||||||t-test, 2 sided|||Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.||||0.63
91655302|NCT02566135|183203546|OTHER|||||||0.29|||||||t-test, 2 sided|||Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.||||0.29
91655303|NCT02566135|183203546|OTHER|||||||0.18|||||||t-test, 2 sided|||Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.||||0.18
91655304|NCT02566135|183203546|OTHER|||||||0.98|||||||t-test, 2 sided|||Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.||||0.98
91710958|NCT03373461|183314358|OTHER||Ratio to placebo (of ratio to baseline)|1.14|||||TWO_SIDED|80.0|0.765|1.699||||||||1.699|0.765|
91614116|NCT01276847|183121948|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.577
91614117|NCT01276847|183121948|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.053
91614118|NCT01276847|183121948|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.098
91614119|NCT00751881|183121955|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|36.3||||0.0001|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between teriflunomide 14 mg and placebo~* H2: No difference between teriflunomide 7 mg and placebo~The study was sized to have 94% power to detect a 25% relative risk reduction in ARR with teriflunomide compared to placebo at a 2-sided 0.05 significance level."||||0.0001
91614120|NCT00751881|183121955|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|22.3||||0.0183|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 7 mg compared to placebo|||||0.0183
91655305|NCT02566135|183203546|OTHER|||||||0.49|||||||t-test, 2 sided|||Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.||||0.49
91710959|NCT03373461|183314358|OTHER||Ratio to placebo (of ratio to baseline)|0.66|||||TWO_SIDED|80.0|0.446|0.984||||||||0.984|0.446|
91614121|NCT00751881|183121956|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|31.5||||0.0442|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* S1: No difference between teriflunomide 14 mg and placebo~* S2: No difference between teriflunomide 7 mg and placebo~The study was also sized to have 75% power to detect a 37% hazard ratio reduction in time to disability progression with teriflunomide compared to placebo."||||0.0442
91614122|NCT00751881|183121956|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|4.5||||0.762|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.7620
91614123|NCT00866294|183121973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.8|-1.1||The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.|ANCOVA|The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).|Mean difference = paroxetine CR minus placebo|||-1.1|-3.8|<0.001
91614124|NCT00492401|183121981|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Expression levels of miR-29b in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.02
91614125|NCT00492401|183121981|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Expression levels of DNMT3a in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.06
91655306|NCT02566135|183203547|OTHER|||||||0.24|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at base line between group I and group C.||||0.24
91655307|NCT02566135|183203547|OTHER|||||||0.11|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.11
91655308|NCT02566135|183203547|OTHER|||||||0.07|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.||||0.07
91655309|NCT02566135|183203547|OTHER|||||||0.85|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.85
91655310|NCT02566135|183203547|OTHER|||||||0.055|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.055
91655311|NCT02566135|183203547|OTHER|||||||0.71|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at ETT insertion time between group I and group C.||||0.71
91655312|NCT02566135|183203547|OTHER|||||||0.2|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.||||0.20
91655313|NCT02566135|183203547|OTHER|||||||0.86|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.||||0.86
91655314|NCT02566135|183203547|OTHER|||||||0.68|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.||||0.68
91655315|NCT02566135|183203547|OTHER|||||||0.98|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.||||0.98
91655316|NCT02566135|183203547|OTHER|||||||0.49|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.||||0.49
91655317|NCT02566135|183203548|OTHER|||||||0.34|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared at base line between group I and group C.||||0.34
91655318|NCT02566135|183203548|OTHER|||||||0.27|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.27
91655319|NCT02566135|183203548|OTHER|||||||0.22|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.||||0.22
91710960|NCT03373461|183314358|OTHER||Ratio to placebo (of ratio to baseline)|0.71|||||TWO_SIDED|80.0|0.501|0.995||||||||0.995|0.501|
91710961|NCT03373461|183314358|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.52|1.107||||||||1.107|0.520|
91710962|NCT03020550|183314369|SUPERIORITY|||||||0.034|||||||ANOVA|Adjusted for baseline GERD symptom severity.||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.||||0.034
91710963|NCT03020550|183314370|SUPERIORITY|||||||0.56|||||||ANOVA|Adjusted for baseline GERD symptom severity||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.||||0.56
91710964|NCT03020550|183314371|SUPERIORITY|||||||0.8|||||||Pearson's correlation test|||The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.||||0.80
91710965|NCT02861664|183314400|OTHER||Least square (LS) mean difference|-0.6|||<|0.0001||95.0|-0.8|-0.4||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.4|-0.8|<.0001
91710966|NCT01000974|183314424|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL.|difference in percentage|-8.59|||||TWO_SIDED|95.0|-12.28|-4.07|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL||-4.07|-12.28|
91710967|NCT01000974|183314424|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBVIPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentrations ≥ 0.15 μg/mL.|Difference in percentage|-0.11|||||TWO_SIDED|95.0|-1.98|2.82|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL||2.82|-1.98|
91710968|NCT01000974|183314425|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to diphtheria (Anti-D).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.81|||Non-inferiority analysis|||Non-inferiority Anti-D antibody concentrations||1.81|-1.26|
91710969|NCT01000974|183314425|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to tetanus (Anti-T).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.8|||Non-inferiority analysis|||Non-inferiority Anti-T antibody concentrations||1.8|-1.26|
91710970|NCT01000974|183314427|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertussis toxoid \[PT\].|GMC ratio|1.017|||||TWO_SIDED|97.5|0.918|1.127|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PT||1.127|0.918|
91527402|NCT02354859|182930006|SUPERIORITY||Difference in Proportions-SAE inicidence|3.1||||0.807|TWO_SIDED|95.0|-10.6|16.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||16.6|-10.6|0.807
91710971|NCT01000974|183314427|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to filamentous hemagglutinin \[FHA\].|GMC ratio|1.088|||||TWO_SIDED|97.5|0.983|1.204|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-FHA||1.204|0.983|
91710972|NCT01000974|183314427|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertactin \[PRN\]|GMC ratio|1.193|||||TWO_SIDED|97.5|1.03|1.382|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PRN||1.382|1.03|
91710973|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.006|||||TWO_SIDED|97.5|0.873|1.159|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 1 concentrations||1.159|0.873|
91710974|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.048|||||TWO_SIDED|97.5|0.921|1.192|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 3 concentrations||1.192|0.921|
91710975|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.886|1.13|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 4 concentrations||1.13|0.886|
91710976|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.02|||||TWO_SIDED|97.5|0.874|1.19|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 5 concentrations||1.19|0.874|
91710977|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.031|||||TWO_SIDED|97.5|0.894|1.188|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6A concentrations||1.188|0.894|
91710978|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.072|||||TWO_SIDED|97.5|0.871|1.32|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6B concentrations||1.32|0.871|
91710979|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.098|||||TWO_SIDED|97.5|0.964|1.251|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 7F concentrations||1.251|0.964|
91710980|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.035|||||TWO_SIDED|97.5|0.89|1.204|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 9V concentrations||1.204|0.89|
91710981|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.096|||||TWO_SIDED|97.5|0.929|1.294|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 14 concentrations||1.294|0.929|
91710982|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.042|||||TWO_SIDED|97.5|0.9|1.207|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 18C concentrations||1.207|0.9|
91710983|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.859|1.167|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19A concentrations||1.167|0.859|
91710984|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|0.969|||||TWO_SIDED|97.5|0.855|1.098|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19F concentrations||1.098|0.855|
91710985|NCT01000974|183314428|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.031|||||TWO_SIDED|97.5|0.862|1.232|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 23F concentrations||1.232|0.862|
91527403|NCT02354859|182930007|SUPERIORITY||Rate Ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks of all participants (not per participant) in the trial was as follows: in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||0.93|0.71|0.002
91614126|NCT01651260|183122006|SUPERIORITY_OR_OTHER||upper probability of failure|0.05||||||||||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||||
91614127|NCT01797029|183122029|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91614128|NCT02101411|183122074|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.19|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||The differences among the three PRU groups (\<85, 85-208,\>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.||||0.002
91710986|NCT01000974|183314429|OTHER|To rule out 10% decrease in seroresponse to FHA in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001|||||||t-test, 1 sided|P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 \& the posterior probability of the cut-off in the control group||Difference in seroresponse Anti-FHA||||<0.0001
91710987|NCT01000974|183314429|OTHER|To rule out 10% decrease in seroresponse to PT in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PT||||<0.0001
91710988|NCT01000974|183314429|OTHER|To rule out 10% decrease in seroresponse to PRN in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PRN||||<0.0001
91710989|NCT01000974|183314430|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 1.|Difference in percentage|-0.67|||||TWO_SIDED|97.5|-2.24|0.87|||Non-inferiority analysis|||Non-inferiority Anti-Polio 1 concentrations||0.87|-2.24|
91710990|NCT01000974|183314430|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 2.|Difference in percentage|0.45|||||TWO_SIDED|97.5|-1.45|2.91|||Non-inferiority analysis|||Non-inferiority Anti-Polio 2 concentration||2.91|-1.45|
91710991|NCT01000974|183314430|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 3.|Difference in percentage|-0.66|||||TWO_SIDED|97.5|-2.2|0.88|||Non-inferiority analysis|||Non-inferiority Anti-Polio 3 concentration||0.88|-2.2|
91710992|NCT03365934|183314469|SUPERIORITY|||||||0.071225|||||||t-test, 2 sided|||||||0.071225
91710993|NCT03365934|183314469|SUPERIORITY|||||||0.092027|||||||t-test, 2 sided|||||||0.092027
91710994|NCT03365934|183314469|SUPERIORITY|||||||0.601716|||||||t-test, 2 sided|||||||0.601716
91614129|NCT02101411|183122074|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.02|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|||The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||||0.002
91614130|NCT03415464|183122078|OTHER|||||||0.134|||||||Chi-squared|||||||0.134
91614131|NCT03596177|183122136|SUPERIORITY||Mean Difference (Net)|-2.58||||0.011|TWO_SIDED|90.0|-4.15|-1.0|||ANCOVA|||||-1.00|-4.15|0.011
91614132|NCT03596177|183122137|SUPERIORITY||Mean Difference (Net)|-45.481||||0.002|TWO_SIDED|90.0|-67.777|-23.186|||ANCOVA|||Statistical Analysis for Day 32||-23.186|-67.777|0.002
91614133|NCT03596177|183122137|SUPERIORITY||Mean Difference (Net)|-41.323||||0.011|TWO_SIDED|90.0|-66.74|-15.907|||ANCOVA|||Statistical Analysis for Day 59||-15.907|-66.740|0.011
91614134|NCT03596177|183122138|SUPERIORITY||Mean Difference (Net)|-1551.194|||<|0.001|TWO_SIDED|90.0|-2190.515|-911.873|||ANCOVA|||Statistical Analysis for Day 32||-911.873|-2190.515|<0.001
91614135|NCT03596177|183122138|SUPERIORITY||Mean Difference (Net)|-1332.515||||0.015|TWO_SIDED|90.0|-2187.711|-477.318|||ANCOVA|||Statistical Analysis for Day 59||-477.318|-2187.711|0.015
91614136|NCT03596177|183122139|SUPERIORITY||Mean Difference (Net)|-3.173||||0.384|TWO_SIDED|90.0|-9.368|3.022|||ANCOVA|||||3.022|-9.368|0.384
91614137|NCT03596177|183122140|SUPERIORITY||Mean Difference (Net)|-10.039||||0.351|TWO_SIDED|90.0|-28.287|8.209|||ANCOVA|||||8.209|-28.287|0.351
91614138|NCT03596177|183122141|SUPERIORITY||Mean Difference (Net)|0.186||||0.968|TWO_SIDED|90.0|-7.858|8.229|||ANCOVA|||||8.229|-7.858|0.968
91614139|NCT03596177|183122142|SUPERIORITY||Mean Difference (Net)|0.867||||0.58|TWO_SIDED|90.0|-1.81|3.545|||ANCOVA|||||3.545|-1.810|0.580
91614140|NCT03596177|183122143|SUPERIORITY||Mean Difference (Net)|-3.645||||0.324|TWO_SIDED|90.0|-9.894|2.603|||ANCOVA|||||2.603|-9.894|0.324
91614141|NCT03596177|183122144|SUPERIORITY||Mean Difference (Net)|-5.672||||0.412|TWO_SIDED|90.0|-17.415|6.072|||ANCOVA|||||6.072|-17.415|0.412
91614142|NCT03596177|183122145|SUPERIORITY||Mean Difference (Net)|7.357||||0.177|TWO_SIDED|90.0|-1.742|16.456|||ANCOVA|||||16.456|-1.742|0.177
91614143|NCT03596177|183122146|SUPERIORITY||Mean Difference (Net)|15.186||||0.168|TWO_SIDED|90.0|-3.151|33.523|||ANCOVA|||||33.523|-3.151|0.168
91614144|NCT03596177|183122147|SUPERIORITY||Mean Difference (Net)|-2.54||||0.009|TWO_SIDED|90.0|-4.05|-1.03|||ANCOVA|||||-1.03|-4.05|0.009
91614145|NCT03596177|183122148|SUPERIORITY||Mean Difference (Net)|-5.122||||0.107|TWO_SIDED|90.0|-10.364|0.119|||ANCOVA|||||0.119|-10.364|0.107
91614146|NCT03596177|183122149|SUPERIORITY||Mean Difference (Net)|-1.848||||0.085|TWO_SIDED|90.0|-3.605|-0.091|||ANCOVA|||||-0.091|-3.605|0.085
91614147|NCT03596177|183122150|SUPERIORITY||Mean Difference (Net)|-3.159||||0.204|TWO_SIDED|90.0|-7.326|1.007|||ANCOVA|||||1.007|-7.326|0.204
91614148|NCT03596177|183122151|SUPERIORITY||Mean Difference (Net)|-0.019||||0.145|TWO_SIDED|90.0|-0.041|0.003|||ANCOVA|||||0.003|-0.041|0.145
91710995|NCT03365934|183314469|SUPERIORITY|||||||0.639911|||||||t-test, 2 sided|||||||0.639911
91710996|NCT03365934|183314469|SUPERIORITY|||||||0.842476|||||||t-test, 2 sided|||||||0.842476
91710997|NCT03365934|183314469|SUPERIORITY|||||||0.999941|||||||t-test, 2 sided|||||||0.999941
91710998|NCT03365934|183314469|SUPERIORITY|||||||0.883479|||||||t-test, 2 sided|||||||0.883479
91710999|NCT03365934|183314469|SUPERIORITY|||||||0.782208|||||||t-test, 2 sided|||||||0.782208
91711000|NCT03365934|183314469|SUPERIORITY|||||||0.607134|||||||t-test, 2 sided|||||||0.607134
91711001|NCT03365934|183314469|SUPERIORITY|||||||0.939549|||||||t-test, 2 sided|||||||0.939549
91711002|NCT03365934|183314469|SUPERIORITY|||||||0.86475|||||||t-test, 2 sided|||||||0.86475
91711003|NCT03365934|183314469|SUPERIORITY|||||||0.704759|||||||t-test, 2 sided|||||||0.704759
91711004|NCT03365934|183314469|SUPERIORITY|||||||0.999989|||||||t-test, 2 sided|||||||0.999989
91711005|NCT03365934|183314469|SUPERIORITY|||||||0.997568|||||||t-test, 2 sided|||||||0.997568
91711006|NCT03365934|183314469|SUPERIORITY|||||||0.999518|||||||t-test, 2 sided|||||||0.999518
91711007|NCT03365934|183314470|SUPERIORITY|||||||0.985332|||||||t-test, 2 sided|||||||0.985332
91711008|NCT03365934|183314470|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91711009|NCT03365934|183314470|SUPERIORITY|||||||0.870459|||||||t-test, 2 sided|||||||0.870459
91711010|NCT03365934|183314470|SUPERIORITY|||||||0.004963|||||||t-test, 2 sided|||||||0.004963
91711011|NCT03365934|183314470|SUPERIORITY|||||||0.071935|||||||t-test, 2 sided|||||||0.071935
91711012|NCT03365934|183314470|SUPERIORITY|||||||0.988995|||||||t-test, 2 sided|||||||0.988995
91711013|NCT03365934|183314470|SUPERIORITY|||||||0.545378|||||||t-test, 2 sided|||||||0.545378
91711014|NCT03365934|183314470|SUPERIORITY|||||||0.000649|||||||t-test, 2 sided|||||||0.000649
91711015|NCT03365934|183314470|SUPERIORITY|||||||0.0146|||||||t-test, 2 sided|||||||0.014600
91711016|NCT03365934|183314470|SUPERIORITY|||||||0.854566|||||||t-test, 2 sided|||||||0.854566
91711017|NCT03365934|183314470|SUPERIORITY|||||||0.004322|||||||t-test, 2 sided|||||||0.004322
91711018|NCT03365934|183314470|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||||||0.0651
91711019|NCT03365934|183314470|SUPERIORITY|||||||0.300536|||||||t-test, 2 sided|||||||0.300536
91711020|NCT03365934|183314470|SUPERIORITY|||||||0.753883|||||||t-test, 2 sided|||||||0.753883
91711021|NCT03365934|183314470|SUPERIORITY|||||||0.97621|||||||t-test, 2 sided|||||||0.97621
91527404|NCT02354859|182930007|SUPERIORITY||Rate Ratio|0.89||||0.783|TWO_SIDED|95.0|0.39|2.03|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||2.03|0.39|0.783
91614149|NCT03596177|183122152|SUPERIORITY||Mean Difference (Net)|-26.001||||0.001|TWO_SIDED|90.0|-37.801|-14.201|||ANCOVA|||||-14.201|-37.801|0.001
91614150|NCT03596177|183122153|SUPERIORITY||Mean Difference (Net)|-12.332||||0.01|TWO_SIDED|90.0|-19.726|-4.938|||ANCOVA|||||-4.938|-19.726|0.010
91614151|NCT01301742|183122159|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.5|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|151.77|165.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|||165.53|151.77|
91614152|NCT01301742|183122160|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|115.0|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|106.15|124.59|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||124.59|106.15|
91614153|NCT01301742|183122161|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.29|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|151.41|165.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||165.49|151.41|
91614154|NCT03059810|183122241|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.63|||TWO_SIDED|95.0|-4.6|5.9|||Linear mixed model (LMM)|A 95% Confidence Interval for the least squares mean difference between the follow up and baseline was used to test for non-inferiority.|Mean difference was calculated as Test (at 12-16 days follow up) - Habitual (at baseline)|It was a single arm study and the subjects' overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).||5.9|-4.6|
91614155|NCT01623531|183122267|SUPERIORITY||Mann-Whitney U test|386.0|STANDARD_ERROR_OF_MEAN|47.5||0.908|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distributions of cumulative transfusion units did not differ significantly between patients receiving either RiaSTAP (median = 0, IQR = 0-1) or Placebo (median = 0, IQR = 0.1), U = 386, SE = 47.60, p = .908.|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the data were not normally distributed, and primary outcomes were zero inflated. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug.||||.908
91614156|NCT01623531|183122268|SUPERIORITY||Mean Difference (Net)|-0.498|STANDARD_ERROR_OF_MEAN|0.239||0.047|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.047
91614157|NCT01623531|183122269|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.0116||0.729|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.729
91614158|NCT01623531|183122270|SUPERIORITY||Mean Difference (Net)|-0.321|STANDARD_ERROR_OF_MEAN|3.699||0.93|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.93
91614159|NCT01623531|183122271|SUPERIORITY||Mean Difference (Net)|-11.821|STANDARD_ERROR_OF_MEAN|8.471||0.169|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|||||.169
91614160|NCT01623531|183122272|SUPERIORITY||Mann-Whitney U test|450.5|STANDARD_ERROR_OF_MEAN|54.163||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.035
91614161|NCT01623531|183122273|SUPERIORITY||Mann-Whitney U test|337.5|STANDARD_ERROR_OF_MEAN|51.591||0.794|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.794
91614162|NCT01623531|183122274|SUPERIORITY||Mann-Whitney U test|335.5|STANDARD_ERROR_OF_MEAN|52.957||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.828
91614163|NCT01623531|183122275|SUPERIORITY||Mann-Whitney U test|396.0|STANDARD_ERROR_OF_MEAN|60.944||0.941|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.941
91711022|NCT03365934|183314471|SUPERIORITY|||||||0.027774|||||||t-test, 2 sided|||||||0.027774
91711023|NCT03365934|183314471|SUPERIORITY|||||||0.08431|||||||t-test, 2 sided|||||||0.08431
91711024|NCT03365934|183314471|SUPERIORITY|||||||0.049247|||||||t-test, 2 sided|||||||0.049247
91711025|NCT03365934|183314471|SUPERIORITY|||||||0.000126|||||||t-test, 2 sided|||||||0.000126
91711026|NCT03365934|183314471|SUPERIORITY|||||||0.010829|||||||t-test, 2 sided|||||||0.010829
91711027|NCT03365934|183314471|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711028|NCT03365934|183314471|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711029|NCT03365934|183314471|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91527405|NCT02354859|182930008|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.479|TWO_SIDED|95.0|-3.66|7.77|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline FEV1 (liters), treatment, visit and a visit-by-visit interaction.|||7.77|-3.66|0.479
91614164|NCT01623531|183122276|SUPERIORITY||Mann-Whitney U test|494.5|STANDARD_ERROR_OF_MEAN|60.783||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.09
91655320|NCT02566135|183203548|OTHER|||||||0.96|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.96
91655321|NCT02566135|183203548|OTHER|||||||0.71|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.71
91655322|NCT02566135|183203548|OTHER|||||||0.55|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.||||0.55
91655323|NCT02566135|183203548|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.||||0.49
91655324|NCT02566135|183203548|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.||||0.49
91655325|NCT02566135|183203548|OTHER|||||||0.76|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.||||0.76
91655326|NCT02566135|183203548|OTHER|||||||0.69|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.||||0.69
91655327|NCT02566135|183203548|OTHER|||||||0.81|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.||||0.81
91655328|NCT02566135|183203549|OTHER||||||<|0.0001|||||||t-test, 2 sided|||We had compared time of insertion for supraglottic airway between group I and group C.||||<0.0001
91655329|NCT02566135|183203550|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91655330|NCT00865709|183203551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.2309|TWO_SIDED|95.0|0.635|1.231||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PFS events would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing the null hypothesis H0: HR ≥ 1 versus the alternative hypothesis H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population, defined as all subjects who were randomized to treatment.||1.231|0.635|0.2309
91655331|NCT00865709|183203553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.829||||0.1437|TWO_SIDED|95.0|0.586|1.174||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PDs would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing H0: HR ≥ 1 versus H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||1.174|0.586|0.1437
91655332|NCT00865709|183203554|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||1-sided p-value from the Cochran-Mantel-Haenszel test, adjusting for the stratification factors of # metastatic sites and liver metastasis determined by Principal Investigator|Cochran-Mantel-Haenszel|||The proportion of subjects achieving overall response (CR or PR), when confirmation of response was not required, was estimated with a 95% confidence interval for each treatment group. The treatment groups were compared with respect to overall response rate using the Cochran-Mantel-Haenszel test, adjusting for the stratification factors.||||0.023
91655333|NCT00429923|183203556|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Mantel Haenszel|||||||0.0014
91655334|NCT03740165|183203586|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0002|TWO_SIDED|95.0|0.53|0.83||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.83|0.53|0.0002
91655335|NCT03740165|183203586|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.19||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.19|0.77|0.3339
91655336|NCT03740165|183203587|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.84||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.84|0.61|<0.0001
91614165|NCT01623531|183122277|SUPERIORITY||Mann-Whitney U test|418.5|STANDARD_ERROR_OF_MEAN|60.93||0.658|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.658
91614166|NCT01623531|183122278|SUPERIORITY||Mann-Whitney U test|472.5|STANDARD_ERROR_OF_MEAN|60.727||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.182
91614167|NCT01623531|183122279|SUPERIORITY||Mann-Whitney U test|428.0|STANDARD_ERROR_OF_MEAN|60.919||0.549|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.549
91614168|NCT01623531|183122280|SUPERIORITY||Mann-Whitney U test|530.5|STANDARD_ERROR_OF_MEAN|60.816||0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distribution of FIBTEM MCF (maximum clot firmness) was significantly different between RiaSTAP (median = 27 mm, IQR = 24, 30), and placebo (median = 23 mm, IQR = 22, 27) groups, U-test = 530.5, SE = 60.816, p = .022).|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the FIBTEM MCF data was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.022
91655337|NCT03740165|183203587|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5527|TWO_SIDED|95.0|0.87|1.18||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.18|0.87|0.5527
91655338|NCT03740165|183203588|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4314|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4314
91614169|NCT01623531|183122281|SUPERIORITY||Mann-Whitney U test|437.0|STANDARD_ERROR_OF_MEAN|60.93||0.455|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.455
91614170|NCT01623531|183122282|SUPERIORITY||Mann-Whitney U test|432.5|STANDARD_ERROR_OF_MEAN|60.819||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.5
91614171|NCT01623531|183122283|SUPERIORITY|||||||1|||||||Fisher Exact|Significance (2-sided) using Fisher's Exact Test.||||||1.0
91614172|NCT02606045|183122295|SUPERIORITY||Mean Difference (Final Values)|46.0||||0.039|TWO_SIDED|95.0|2.0|90.0|||Mixed Models Analysis|||||90|2|0.039
91614173|NCT02606045|183122296|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||||0.7|-0.7|0.998
91614174|NCT02606045|183122297|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.168|TWO_SIDED|95.0|-1.0|5.8|||Mixed Models Analysis|||||5.8|-1.0|0.168
91614175|NCT02606045|183122298|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.055|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.055
91614176|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.681|TWO_SIDED|95.0|-4.8|3.2|||Mixed Models Analysis|||||3.2|-4.8|0.681
91614177|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.633|TWO_SIDED|95.0|-12.4|7.6|||Mixed Models Analysis|||Role limitations of physical health||7.6|-12.4|0.633
91614178|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.362|TWO_SIDED|95.0|-5.7|15.3|||Mixed Models Analysis|||Role limitations of emotional health||15.3|-5.7|0.362
91614179|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.375|TWO_SIDED|95.0|-7.4|2.8|||Mixed Models Analysis|||Energy/fatigue||2.8|-7.4|0.375
91614180|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.068|TWO_SIDED|95.0|-0.3|7.4|||Mixed Models Analysis|||Emotional well-being||7.4|-0.3|0.068
91614181|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.189|TWO_SIDED|95.0|-2.3|11.3|||Mixed Models Analysis|||Social functioning||11.3|-2.3|0.189
91614182|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.489|TWO_SIDED|95.0|-9.2|4.5|||Mixed Models Analysis|||Pain||4.5|-9.2|0.489
91614183|NCT02606045|183122299|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.3|||Mixed Models Analysis|||General Health||4.3|-3.2|0.786
91614184|NCT02606045|183122300|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.098|TWO_SIDED|95.0|-2.3|0.2|||Mixed Models Analysis|||Physically Unhealthy Days||0.2|-2.3|0.098
91614185|NCT02606045|183122300|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.557|TWO_SIDED|95.0|-1.6|3.0|||Mixed Models Analysis|||Mentally Unhealthy Days||3.0|-1.6|0.557
91614186|NCT02606045|183122301|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.266|TWO_SIDED|95.0|0.8|2.7|||Mixed Models Analysis|||Cycle Severity Rating||2.7|0.8|0.266
91711030|NCT03365934|183314471|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91655339|NCT03740165|183203588|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3107|TWO_SIDED|95.0|0.72|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.72|0.3107
91655340|NCT03740165|183203589|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6716|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.25|0.87|0.6716
91655341|NCT03740165|183203589|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7448|TWO_SIDED|95.0|0.89|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.89|0.7448
91655342|NCT03740165|183203590|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0012|TWO_SIDED|95.0|0.5|0.86||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.86|0.50|0.0012
91655343|NCT03740165|183203590|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4366|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4366
91655344|NCT03740165|183203591|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.61|0.89||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.89|0.61|0.0008
91655345|NCT03740165|183203591|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7174|TWO_SIDED|95.0|0.88|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.88|0.7174
91655346|NCT03740165|183203592|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0228|TWO_SIDED|95.0|0.62|1.0||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.00|0.62|0.0228
91655347|NCT03740165|183203592|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3935|TWO_SIDED|95.0|0.77|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.77|0.3935
91711031|NCT03365934|183314471|SUPERIORITY|||||||0.999533|||||||t-test, 2 sided|||||||0.999533
91655348|NCT03740165|183203593|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0573|TWO_SIDED|95.0|0.74|1.03||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.03|0.74|0.0573
91655349|NCT03740165|183203593|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7234|TWO_SIDED|95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7234
91711032|NCT03365934|183314471|SUPERIORITY|||||||0.4205363|||||||t-test, 2 sided|||||||0.4205363
91711033|NCT03365934|183314471|SUPERIORITY|||||||0.9802252|||||||t-test, 2 sided|||||||0.9802252
91711034|NCT03365934|183314471|SUPERIORITY|||||||0.6845362|||||||t-test, 2 sided|||||||0.6845362
91711035|NCT03365934|183314471|SUPERIORITY|||||||0.9992002|||||||t-test, 2 sided|||||||0.9992002
91711036|NCT03365934|183314471|SUPERIORITY|||||||0.8562779|||||||t-test, 2 sided|||||||0.8562779
91711037|NCT03365934|183314472|SUPERIORITY|||||||0.0403539|||||||t-test, 2 sided|||||||0.0403539
91711038|NCT03365934|183314472|SUPERIORITY|||||||0.2953049|||||||t-test, 2 sided|||||||0.2953049
91711039|NCT03365934|183314472|SUPERIORITY|||||||0.290551|||||||t-test, 2 sided|||||||0.290551
91711040|NCT03365934|183314472|SUPERIORITY|||||||2.47e-05|||||||t-test, 2 sided|||||||0.0000247
91711041|NCT03365934|183314472|SUPERIORITY|||||||0.0133001|||||||t-test, 2 sided|||||||0.0133001
91711042|NCT03365934|183314472|SUPERIORITY|||||||1.67e-05|||||||t-test, 2 sided|||||||0.0000167
91711043|NCT03365934|183314472|SUPERIORITY|||||||2.12e-05|||||||t-test, 2 sided|||||||0.0000212
91614187|NCT00365716|183122303|SUPERIORITY_OR_OTHER||Vaccine Efficacy|89.5||||||95.0|70.7|97.3|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.3|70.7|
91614188|NCT00455858|183122330|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.356|||<|0.0001||95.0|-1.368|-1.344|||t-test|||||-1.344|-1.368|<.0001
91614189|NCT00455858|183122331|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.338|||<|0.0001||95.0|-1.35|-1.327|||t-test|||||-1.327|-1.350|<.0001
91614190|NCT00455858|183122332|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-69.553|||<|0.0001||95.0|-70.047|-69.06|||Paired t-test|||Estimated mean decrease in FPG at week 12||-69.060|-70.047|<.0001
91655350|NCT03740165|183203594|SUPERIORITY||Difference in Least Squares Means (LSM)|0.26||||0.8481|TWO_SIDED|95.0|-2.44|2.97|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.97|-2.44|0.8481
91655351|NCT03740165|183203594|SUPERIORITY||Difference in LS Means|-1.1||||0.4335|TWO_SIDED|95.0|-3.87|1.66|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||1.66|-3.87|0.4335
91711044|NCT03365934|183314472|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711045|NCT03365934|183314472|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711046|NCT03365934|183314472|SUPERIORITY|||||||0.99999995|||||||t-test, 2 sided|||||||0.99999995
91655352|NCT03740165|183203595|SUPERIORITY||Difference in Least Squares Means (LSM)|0.14||||0.9024|TWO_SIDED|95.0|-2.15|2.44|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.44|-2.15|0.9024
91711047|NCT03365934|183314472|SUPERIORITY|||||||0.0792013|||||||t-test, 2 sided|||||||0.0792013
91711048|NCT03365934|183314472|SUPERIORITY|||||||0.870163|||||||t-test, 2 sided|||||||0.870163
91614191|NCT00455858|183122332|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-72.159|||<|0.0001||95.0|-72.647|-71.671|||Paired t-test|||Estimated mean decrease in FPG at week 20||-71.671|-72.647|<.0001
91614192|NCT03242759|183122427|OTHER|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.505
91614193|NCT03242759|183122427|OTHER|||||||0.181|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.181
91614194|NCT03242759|183122428|OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.571
91614195|NCT03242759|183122428|OTHER|||||||0.232|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.232
91614196|NCT03242759|183122429|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
91614197|NCT03242759|183122429|OTHER|||||||0.375|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.375
91614198|NCT03242759|183122430|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.027
91614199|NCT03242759|183122430|OTHER|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.938
91614200|NCT03242759|183122431|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.001
91614201|NCT03242759|183122431|OTHER|||||||0.048|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.048
91614202|NCT03242759|183122432|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.018
91614203|NCT03242759|183122432|OTHER|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.125
91614204|NCT03242759|183122433|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.073
91614205|NCT03242759|183122433|OTHER|||||||0.755|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.755
91614206|NCT03242759|183122434|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
91614207|NCT03242759|183122434|OTHER|||||||0.281|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.281
91614208|NCT03242759|183122435|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
91614209|NCT03242759|183122435|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.008
91614210|NCT03242759|183122436|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
91614211|NCT03242759|183122436|OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.031
91711049|NCT03365934|183314472|SUPERIORITY|||||||0.103828|||||||t-test, 2 sided|||||||0.103828
91711050|NCT03365934|183314472|SUPERIORITY|||||||0.900265|||||||t-test, 2 sided|||||||0.900265
91711051|NCT03365934|183314472|SUPERIORITY|||||||0.570015|||||||t-test, 2 sided|||||||0.570015
91711052|NCT03365934|183314473|SUPERIORITY|||||||0.882449|||||||t-test, 2 sided|||||||0.882449
91711053|NCT03365934|183314473|SUPERIORITY|||||||0.088558|||||||t-test, 2 sided|||||||0.088558
91711054|NCT03365934|183314473|SUPERIORITY|||||||0.081846|||||||t-test, 2 sided|||||||0.081846
91711055|NCT03365934|183314473|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711056|NCT03365934|183314473|SUPERIORITY|||||||3.03e-05|||||||t-test, 2 sided|||||||0.0000303
91711057|NCT03365934|183314473|SUPERIORITY|||||||0.001817|||||||t-test, 2 sided|||||||0.001817
91711058|NCT03365934|183314473|SUPERIORITY|||||||0.001825|||||||t-test, 2 sided|||||||0.001825
91711059|NCT03365934|183314473|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711060|NCT03365934|183314473|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711061|NCT03365934|183314473|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
91711062|NCT03365934|183314473|SUPERIORITY|||||||0.038836|||||||t-test, 2 sided|||||||0.038836
91711063|NCT03365934|183314473|SUPERIORITY|||||||0.184508|||||||t-test, 2 sided|||||||0.184508
91711064|NCT03365934|183314473|SUPERIORITY|||||||0.062829|||||||t-test, 2 sided|||||||0.062829
91527406|NCT02354859|182930009|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.054|TWO_SIDED|95.0|-1.49|0.01|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 28 and Day 56. Mixed-effects repeated measures model includes terms for the baseline Pa density (log10 (CFU)), treatment, visit and a visit-by-visit interaction.|||0.01|-1.49|0.054
91655353|NCT03740165|183203595|SUPERIORITY||Difference in Least Squares Means (LSM)|-0.08||||0.9478|TWO_SIDED|95.0|-2.47|2.31|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.31|-2.47|0.9478
91655354|NCT03740165|183203596|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2644|TWO_SIDED|95.0|0.73|1.17||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.17|0.73|0.2644
91655355|NCT03740165|183203596|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1953|TWO_SIDED|95.0|0.71|1.14||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.14|0.71|0.1953
91655356|NCT03740165|183203597|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5188|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5188
91655357|NCT03740165|183203597|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5091|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5091
91655358|NCT03740165|183203598|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.51|0.79||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.79|0.51|<0.0001
91655359|NCT03740165|183203598|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0981|TWO_SIDED|95.0|0.7|1.08||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.08|0.70|0.0981
91711065|NCT03365934|183314473|SUPERIORITY|||||||0.253458|||||||t-test, 2 sided|||||||0.253458
91655360|NCT03740165|183203599|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.8||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.80|0.59|<0.0001
91655361|NCT03740165|183203599|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1206|TWO_SIDED|95.0|0.79|1.06||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.06|0.79|0.1206
91655362|NCT03740165|183203600|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0316||95.0|0.63|1.01||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.01|0.63|0.0316
91655363|NCT03740165|183203600|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4441||95.0|0.78|1.24||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.24|0.78|0.4441
91711066|NCT03365934|183314473|SUPERIORITY|||||||0.987798|||||||t-test, 2 sided|||||||0.987798
91711067|NCT03365934|183314474|SUPERIORITY|||||||0.516068|||||||t-test, 2 sided|||||||0.516068
91711068|NCT03365934|183314474|SUPERIORITY|||||||0.358412|||||||t-test, 2 sided|||||||0.358412
91711069|NCT03365934|183314474|SUPERIORITY|||||||0.834145|||||||t-test, 2 sided|||||||0.834145
91711070|NCT03365934|183314474|SUPERIORITY|||||||3.5e-05|||||||t-test, 2 sided|||||||0.000035
91711071|NCT03365934|183314474|SUPERIORITY|||||||0.000843|||||||t-test, 2 sided|||||||0.000843
91711072|NCT03365934|183314474|SUPERIORITY|||||||0.002997|||||||t-test, 2 sided|||||||0.002997
91711073|NCT03365934|183314474|SUPERIORITY|||||||0.051717|||||||t-test, 2 sided|||||||0.051717
91711074|NCT03365934|183314474|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711075|NCT03365934|183314474|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91614212|NCT03242759|183122438|OTHER||||||<|0.001|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
91614213|NCT03242759|183122438|OTHER|||||||0.939|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.939
91614214|NCT03242759|183122439|OTHER|||||||0.169|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.169
91614215|NCT03242759|183122439|OTHER|||||||0.545|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.545
91614216|NCT03242759|183122440|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.333
91614217|NCT03242759|183122440|OTHER|||||||0.786|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.786
91655364|NCT03740165|183203601|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0853||95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.05|0.76|0.0853
91655365|NCT03740165|183203601|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7165||95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7165
91655366|NCT03740165|183203602|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1029|TWO_SIDED|95.0|0.71|1.08||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.08|0.71|0.1029
91711076|NCT03365934|183314474|SUPERIORITY|||||||0.985602|||||||t-test, 2 sided|||||||0.985602
91614218|NCT03242759|183122441|OTHER|||||||0.245|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.245
91614219|NCT03242759|183122441|OTHER|||||||0.454|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.454
91614220|NCT03242759|183122442|OTHER|||||||0.543|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.543
91614221|NCT03242759|183122442|OTHER|||||||0.733|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.733
91614222|NCT03242759|183122443|OTHER|||||||0.046|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.046
91614223|NCT03242759|183122443|OTHER|||||||0.898|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.898
91614224|NCT03117049|183122451|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|96.37|0.43|0.71|||Stratified log-rank test|||||0.71|0.43|<0.0001
91614225|NCT03117049|183122452|SUPERIORITY||Stratified hazard ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||||1.14|0.63|
91614226|NCT03117049|183122453|SUPERIORITY||Odds Ratio (OR)|1.55|||||TWO_SIDED|95.0|1.11|2.17||||||||2.17|1.11|
91614227|NCT03117049|183122454|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
91614228|NCT00872833|183122457|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
91614229|NCT00872833|183122458|SUPERIORITY_OR_OTHER|||||||0.028|||||||Chi-squared|||||||0.028
91614230|NCT00839098|183122459|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
91614231|NCT00839098|183122460|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91614232|NCT00839098|183122461|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91614233|NCT00839098|183122462|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91614234|NCT00839098|183122463|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91614235|NCT00839098|183122464|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||P values below 0.05 were considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||||||>0.05
91614236|NCT00839098|183122465|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91614237|NCT01345786|183122466|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|137.5||||||90.0|131.0|144.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||144.4|131|
91614238|NCT01345786|183122466|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|111.8||||||90.0|107.5|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|107.5|
91614239|NCT01345786|183122467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|107.3||||||90.0|99.0|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|99|
91614240|NCT01345786|183122467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.6||||||90.0|99.2|108.2|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||108.2|99.2|
91614241|NCT01345786|183122468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|110.0||||||90.0|106.4|113.7|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUClast||113.7|106.4|
91614242|NCT01345786|183122468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.3||||||90.0|100.9|105.7|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC last||105.7|100.9|
91655367|NCT03740165|183203602|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.8231|TWO_SIDED|95.0|0.9|1.36||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.36|0.90|0.8231
91711077|NCT03365934|183314474|SUPERIORITY|||||||0.046422|||||||t-test, 2 sided|||||||0.046422
91711078|NCT03365934|183314474|SUPERIORITY|||||||0.28061|||||||t-test, 2 sided|||||||0.28061
91655368|NCT03740165|183203603|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0442||95.0|0.76|1.02||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.02|0.76|0.0442
91655369|NCT03740165|183203603|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.9565||95.0|0.98|1.31||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.31|0.98|0.9565
91711079|NCT03365934|183314474|SUPERIORITY|||||||0.011015|||||||t-test, 2 sided|||||||0.011015
91711080|NCT03365934|183314474|SUPERIORITY|||||||0.089156|||||||t-test, 2 sided|||||||0.089156
91711081|NCT03365934|183314474|SUPERIORITY|||||||0.963882|||||||t-test, 2 sided|||||||0.963882
91711082|NCT03365934|183314475|SUPERIORITY|||||||0.00526|||||||t-test, 2 sided|||||||0.00526
91655370|NCT03740165|183203604|SUPERIORITY||Difference in Percentage|5.4||||0.0644|TWO_SIDED|95.0|-1.9|11.5||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|t-test, 1 sided||Based on Miettinen \& Nurminen method stratified by bevacizumab use (Yes vs No)|||11.5|-1.9|0.0644
91711083|NCT03365934|183314475|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91711084|NCT03365934|183314475|SUPERIORITY|||||||0.914409|||||||t-test, 2 sided|||||||0.914409
91711085|NCT03365934|183314475|SUPERIORITY|||||||0.013004|||||||t-test, 2 sided|||||||0.013004
91711086|NCT03365934|183314475|SUPERIORITY|||||||0.028517|||||||t-test, 2 sided|||||||0.028517
91711087|NCT03365934|183314475|SUPERIORITY|||||||0.001356|||||||t-test, 2 sided|||||||0.001356
91711088|NCT03365934|183314475|SUPERIORITY|||||||5.9e-05|||||||t-test, 2 sided|||||||0.000059
91711089|NCT03365934|183314475|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711090|NCT03365934|183314475|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711091|NCT03365934|183314475|SUPERIORITY|||||||0.859272|||||||t-test, 2 sided|||||||0.859272
91711092|NCT03365934|183314475|SUPERIORITY|||||||0.002821|||||||t-test, 2 sided|||||||0.002821
91711093|NCT03365934|183314475|SUPERIORITY|||||||0.007492|||||||t-test, 2 sided|||||||0.007492
91711094|NCT03365934|183314475|SUPERIORITY|||||||0.208803|||||||t-test, 2 sided|||||||0.208803
91711095|NCT03365934|183314475|SUPERIORITY|||||||0.341884|||||||t-test, 2 sided|||||||0.341884
91711096|NCT03365934|183314475|SUPERIORITY|||||||0.999531|||||||t-test, 2 sided|||||||0.999531
91711097|NCT03365934|183314476|SUPERIORITY|||||||0.066788|||||||t-test, 2 sided|||||||0.066788
91711098|NCT03365934|183314476|SUPERIORITY|||||||0.942653|||||||t-test, 2 sided|||||||0.942653
91711099|NCT03365934|183314476|SUPERIORITY|||||||0.893545|||||||t-test, 2 sided|||||||0.893545
91711100|NCT03365934|183314476|SUPERIORITY|||||||0.165225|||||||t-test, 2 sided|||||||0.165225
91711101|NCT03365934|183314476|SUPERIORITY|||||||0.140475|||||||t-test, 2 sided|||||||0.140475
91711102|NCT03365934|183314476|SUPERIORITY|||||||0.002026|||||||t-test, 2 sided|||||||0.002026
91711103|NCT03365934|183314476|SUPERIORITY|||||||0.001916|||||||t-test, 2 sided|||||||0.001916
91711104|NCT03365934|183314476|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711105|NCT03365934|183314476|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711106|NCT03365934|183314476|SUPERIORITY|||||||0.999957|||||||t-test, 2 sided|||||||0.999957
91711107|NCT03365934|183314476|SUPERIORITY|||||||0.672573|||||||t-test, 2 sided|||||||0.672573
91711108|NCT03365934|183314476|SUPERIORITY|||||||0.630145|||||||t-test, 2 sided|||||||0.630145
91711109|NCT03365934|183314476|SUPERIORITY|||||||0.832757|||||||t-test, 2 sided|||||||0.832757
91711110|NCT03365934|183314476|SUPERIORITY|||||||0.803277|||||||t-test, 1 sided|||||||0.803277
91711111|NCT03365934|183314476|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91711112|NCT03365934|183314477|SUPERIORITY|||||||0.943522|||||||t-test, 2 sided|||||||0.943522
91711113|NCT03365934|183314477|SUPERIORITY|||||||0.002376|||||||t-test, 2 sided|||||||0.002376
91711114|NCT03365934|183314477|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711115|NCT03365934|183314477|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711116|NCT03365934|183314477|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711117|NCT03365934|183314477|SUPERIORITY|||||||0.061015|||||||t-test, 2 sided|||||||0.061015
91711118|NCT03365934|183314477|SUPERIORITY|||||||0.000211|||||||t-test, 2 sided|||||||0.000211
91711119|NCT03365934|183314477|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711120|NCT03365934|183314477|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711121|NCT03365934|183314477|SUPERIORITY|||||||0.412626|||||||t-test, 2 sided|||||||0.412626
91711122|NCT03365934|183314477|SUPERIORITY|||||||0.104388|||||||t-test, 2 sided|||||||0.104388
91711123|NCT03365934|183314477|SUPERIORITY|||||||0.197791|||||||t-test, 2 sided|||||||0.197791
91711124|NCT03365934|183314477|SUPERIORITY|||||||0.994413|||||||t-test, 2 sided|||||||0.994413
91711125|NCT03365934|183314477|SUPERIORITY|||||||0.999851|||||||t-test, 2 sided|||||||0.999851
91655371|NCT03740165|183203605|SUPERIORITY||Difference in Percentage|3.7||||0.0318|TWO_SIDED|95.0|-0.3|7.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|t-test, 1 sided||Based on Miettinen \& Nurminen method stratified by bevacizumab use (Yes vs No) and PD-L1 CPS (\<10 vs ≥10)|||7.3|-0.3|0.0318
91655372|NCT03049618|183203613|OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
91655373|NCT03049618|183203614|OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
91655374|NCT03049618|183203615|OTHER|||||||0.057|||||||Fisher Exact|||||||0.057
91655375|NCT03049618|183203616|OTHER|||||||1|||||||Fisher Exact|||||||1.00
91655376|NCT03049618|183203618|OTHER|||||||0.83|||||||Log Rank|||||||0.83
91655377|NCT03049618|183203619|OTHER|||||||0.83|||||||Log Rank|||||||0.83
91655378|NCT03049618|183203620|OTHER|||||||0.83|||||||Log Rank|||||||0.83
91655379|NCT03049618|183203621|OTHER|||||||0.47|||||||Log Rank|||||||0.47
91655380|NCT03049618|183203623|OTHER|||||||0.83|||||||Log Rank|||||||0.83
91655381|NCT03049618|183203624|OTHER|||||||0.83|||||||Log Rank|||||||0.83
91655382|NCT03049618|183203625|OTHER|||||||0.11|||||||Log Rank|||||||0.11
91655383|NCT03049618|183203626|OTHER|||||||0.96|||||||Log Rank|||||||0.96
91655384|NCT01055223|183203628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|1.13|1.78|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.78|1.13|
91655385|NCT01055223|183203628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.93|1.52|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.52|0.93|
91655386|NCT01055223|183203628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|0.78|2.98|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||2.98|0.78|
91655387|NCT01055223|183203628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|0.74|2.89|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||2.89|0.74|
91655388|NCT01055223|183203628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|0.18|22.14|||||Undadjusted Odds Ratio. Reference Group: TZD alone.|||22.14|0.18|
91655389|NCT01055223|183203628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.12|15.5|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.50|0.12|
91655390|NCT01055223|183203629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|1.05|1.89|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.89|1.05|
91655391|NCT01055223|183203629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.65|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.65|0.88|
91655392|NCT01055223|183203629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||3.60|0.69|
91655393|NCT01055223|183203629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.7|3.81|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||3.81|0.70|
91655394|NCT01055223|183203629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
91655395|NCT01055223|183203629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
91655396|NCT01055223|183203630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.92|1.79|||||Unadjusted Odds Ratio. Reference Group: TZD alone.|||1.79|0.92|
91655397|NCT01055223|183203630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.71|1.45|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.45|0.71|
91655398|NCT01055223|183203630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||||TWO_SIDED|95.0|0.1|1.9|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.90|0.10|
91655399|NCT01055223|183203630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||||TWO_SIDED|95.0|0.08|1.54|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.54|0.08|
91655400|NCT01055223|183203630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|0.18|21.93|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||21.93|0.18|
91655401|NCT01055223|183203630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.09|12.36|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||12.36|0.09|
91711126|NCT03365934|183314477|SUPERIORITY|||||||0.999621|||||||t-test, 2 sided|||||||0.999621
91711127|NCT03365934|183314478|SUPERIORITY|||||||0.193667|||||||t-test, 2 sided|||||||0.193667
91711128|NCT03365934|183314478|SUPERIORITY|||||||0.526573|||||||t-test, 2 sided|||||||0.526573
91711129|NCT03365934|183314478|SUPERIORITY|||||||0.898749|||||||t-test, 2 sided|||||||0.898749
91711130|NCT03365934|183314478|SUPERIORITY|||||||0.975044|||||||t-test, 2 sided|||||||0.975044
91711131|NCT03365934|183314478|SUPERIORITY|||||||0.760706|||||||t-test, 2 sided|||||||0.760706
91711132|NCT03365934|183314478|SUPERIORITY|||||||0.985237|||||||t-test, 2 sided|||||||0.985237
91711133|NCT03365934|183314478|SUPERIORITY|||||||0.837995|||||||t-test, 2 sided|||||||0.837995
91711134|NCT03365934|183314478|SUPERIORITY|||||||0.592697|||||||t-test, 2 sided|||||||0.592697
91711135|NCT03365934|183314478|SUPERIORITY|||||||0.912495|||||||t-test, 2 sided|||||||0.912495
91711136|NCT03365934|183314478|SUPERIORITY|||||||0.99245|||||||t-test, 2 sided|||||||0.99245
91711137|NCT03365934|183314478|SUPERIORITY|||||||0.925553|||||||t-test, 2 sided|||||||0.925553
91655402|NCT01055223|183203631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.8|1.88|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.88|0.80|
91655403|NCT01055223|183203631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.57|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.57|0.62|
91711138|NCT03365934|183314478|SUPERIORITY|||||||0.999171|||||||t-test, 2 sided|||||||0.999171
91711139|NCT03365934|183314478|SUPERIORITY|||||||0.999324|||||||t-test, 2 sided|||||||0.999324
91711140|NCT03365934|183314478|SUPERIORITY|||||||0.999913|||||||t-test, 2 sided|||||||0.999913
91711141|NCT03365934|183314478|SUPERIORITY|||||||0.990516|||||||t-test, 2 sided|||||||0.990516
91711142|NCT03365934|183314479|SUPERIORITY|||||||0.92106|||||||t-test, 2 sided|||||||0.92106
91711143|NCT03365934|183314479|SUPERIORITY|||||||0.976812|||||||t-test, 2 sided|||||||0.976812
91655404|NCT01055223|183203631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
91655405|NCT01055223|183203631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
91655406|NCT01055223|183203631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
91711144|NCT03365934|183314479|SUPERIORITY|||||||0.233992|||||||t-test, 2 sided|||||||0.233992
91711145|NCT03365934|183314479|SUPERIORITY|||||||0.007591|||||||t-test, 2 sided|||||||0.007591
91711146|NCT03365934|183314479|SUPERIORITY|||||||0.038958|||||||t-test, 2 sided|||||||0.038958
91711147|NCT03365934|183314479|SUPERIORITY|||||||0.99809|||||||t-test, 2 sided|||||||0.99809
91711148|NCT03365934|183314479|SUPERIORITY|||||||0.773028|||||||t-test, 2 sided|||||||0.773028
91711149|NCT03365934|183314479|SUPERIORITY|||||||0.135805|||||||t-test, 2 sided|||||||0.135805
91711150|NCT03365934|183314479|SUPERIORITY|||||||0.350556|||||||t-test, 2 sided|||||||0.350556
91711151|NCT03365934|183314479|SUPERIORITY|||||||0.61046|||||||t-test, 2 sided|||||||0.61046
91711152|NCT03365934|183314479|SUPERIORITY|||||||0.062163|||||||t-test, 2 sided|||||||0.062163
91711153|NCT03365934|183314479|SUPERIORITY|||||||0.203418|||||||t-test, 2 sided|||||||0.203418
91711154|NCT03365934|183314479|SUPERIORITY|||||||0.942304|||||||t-test, 2 sided|||||||0.942304
91711155|NCT03365934|183314479|SUPERIORITY|||||||0.995238|||||||t-test, 2 sided|||||||0.995238
91711156|NCT03365934|183314479|SUPERIORITY|||||||0.99858|||||||t-test, 2 sided|||||||0.99858
91711157|NCT03365934|183314480|SUPERIORITY|||||||0.998949|||||||t-test, 2 sided|||||||0.998949
91711158|NCT03365934|183314480|SUPERIORITY|||||||0.111084|||||||t-test, 2 sided|||||||0.111084
91711159|NCT03365934|183314480|SUPERIORITY|||||||0.456846|||||||t-test, 2 sided|||||||0.456846
91711160|NCT03365934|183314480|SUPERIORITY|||||||0.00062|||||||t-test, 2 sided|||||||0.00062
91711161|NCT03365934|183314480|SUPERIORITY|||||||0.006871|||||||t-test, 2 sided|||||||0.006871
91711162|NCT03365934|183314480|SUPERIORITY|||||||0.039407|||||||t-test, 2 sided|||||||0.039407
91711163|NCT03365934|183314480|SUPERIORITY|||||||0.245375|||||||t-test, 2 sided|||||||0.245375
91711164|NCT03365934|183314480|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
91711165|NCT03365934|183314480|SUPERIORITY|||||||0.001612|||||||t-test, 2 sided|||||||0.001612
91711166|NCT03365934|183314480|SUPERIORITY|||||||0.988067|||||||t-test, 2 sided|||||||0.988067
91711167|NCT03365934|183314480|SUPERIORITY|||||||0.599171|||||||t-test, 2 sided|||||||0.599171
91711168|NCT03365934|183314480|SUPERIORITY|||||||0.928722|||||||t-test, 2 sided|||||||0.928722
91711169|NCT03365934|183314480|SUPERIORITY|||||||0.256079|||||||t-test, 2 sided|||||||0.256079
91711170|NCT03365934|183314480|SUPERIORITY|||||||0.626498|||||||t-test, 2 sided|||||||0.626498
91711171|NCT03365934|183314480|SUPERIORITY|||||||0.988693|||||||t-test, 2 sided|||||||0.988693
91711172|NCT03365934|183314481|SUPERIORITY|||||||0.99916|||||||t-test, 2 sided|||||||0.99916
91711173|NCT03365934|183314481|SUPERIORITY|||||||0.016246|||||||t-test, 2 sided|||||||0.016246
91711174|NCT03365934|183314481|SUPERIORITY|||||||0.289112|||||||t-test, 2 sided|||||||0.289112
91711175|NCT03365934|183314481|SUPERIORITY|||||||3.8e-05|||||||t-test, 2 sided|||||||0.000038
91711176|NCT03365934|183314481|SUPERIORITY|||||||0.014558|||||||t-test, 2 sided|||||||0.014558
91711177|NCT03365934|183314481|SUPERIORITY|||||||0.03731|||||||t-test, 2 sided|||||||0.03731
91711178|NCT03365934|183314481|SUPERIORITY|||||||0.465745|||||||t-test, 2 sided|||||||0.465745
91711179|NCT03365934|183314481|SUPERIORITY|||||||0.000112|||||||t-test, 2 sided|||||||0.000112
91711180|NCT03365934|183314481|SUPERIORITY|||||||0.034575|||||||t-test, 2 sided|||||||0.034575
91711181|NCT03365934|183314481|SUPERIORITY|||||||0.889597|||||||t-test, 2 sided|||||||0.889597
91711182|NCT03365934|183314481|SUPERIORITY|||||||0.726932|||||||t-test, 2 sided|||||||0.726932
91711183|NCT03365934|183314481|SUPERIORITY|||||||0.999998|||||||t-test, 2 sided|||||||0.999998
91711184|NCT03365934|183314481|SUPERIORITY|||||||0.130235|||||||t-test, 2 sided|||||||0.130235
91711185|NCT03365934|183314481|SUPERIORITY|||||||0.910989|||||||t-test, 2 sided|||||||0.910989
91711186|NCT03365934|183314481|SUPERIORITY|||||||0.616933|||||||t-test, 2 sided|||||||0.616933
91711187|NCT03365934|183314482|SUPERIORITY|||||||0.999952|||||||t-test, 2 sided|||||||0.999952
91711188|NCT03365934|183314482|SUPERIORITY|||||||0.421347|||||||t-test, 2 sided|||||||0.421347
91711189|NCT03365934|183314482|SUPERIORITY|||||||0.598141|||||||t-test, 2 sided|||||||0.598141
91711190|NCT03365934|183314482|SUPERIORITY|||||||0.000197|||||||t-test, 2 sided|||||||0.000197
91711191|NCT03365934|183314482|SUPERIORITY|||||||0.000115|||||||t-test, 2 sided|||||||0.000115
91711192|NCT03365934|183314482|SUPERIORITY|||||||0.511155|||||||t-test, 2 sided|||||||0.511155
91711193|NCT03365934|183314482|SUPERIORITY|||||||0.693868|||||||t-test, 2 sided|||||||0.693868
91791315|NCT00492063|183460306|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|0.0|||||TWO_SIDED|95.0|-6.0|5.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||5|-6|
91711194|NCT03365934|183314482|SUPERIORITY|||||||0.000232|||||||t-test, 2 sided|||||||0.000232
91711195|NCT03365934|183314482|SUPERIORITY|||||||0.000133|||||||t-test, 2 sided|||||||0.000133
91711196|NCT03365934|183314482|SUPERIORITY|||||||0.999894|||||||t-test, 2 sided|||||||0.999894
91655407|NCT01055223|183203631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates|||0.00|0.00|
91655408|NCT01055223|183203632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||||TWO_SIDED|95.0|1.53|19.45|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||19.45|1.53|
91655409|NCT01055223|183203632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||||TWO_SIDED|95.0|0.64|15.86|||||Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.86|0.64|
91655410|NCT01055223|183203632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
91655411|NCT01055223|183203632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
91655412|NCT01055223|183203632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
91655413|NCT01055223|183203632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
91655414|NCT01055223|183203633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.26|||||TWO_SIDED|95.0|0.66|80.35|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||80.35|0.66|
91655415|NCT01055223|183203633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.03|96.47|||||Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates.|||96.47|0.03|
91655416|NCT01055223|183203633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference Group: TZD alone.|||0.00|0.00|
91655417|NCT01055223|183203633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
91655418|NCT01055223|183203633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
91655419|NCT01055223|183203633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
91655420|NCT03387033|183203635|OTHER||||||<|0.005|||||||Paired t-test|||||||<0.005
91655421|NCT03387033|183203636|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
91655422|NCT03387033|183203637|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
91655423|NCT00076102|183203678|OTHER|||||||0.0301||||||The reported F statistic and p-value are representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Adaptive Behavior.|ANOVA|||F=5.45 under the null hypothesis||||0.0301
91655424|NCT00076102|183203678|OTHER|||||||0.0186||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Emotional Functioning.|ANOVA|||F = 6.56 under the null hypothesis||||0.0186
91655425|NCT00076102|183203678|OTHER|||||||0.0032||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Medical/Physical Status.|ANOVA|||F=11.23 under the null hypothesis||||0.0032
91655426|NCT00076102|183203679|OTHER|||||||0.6263|||||||ANOVA|||F=0.25 under the null hypothesis||||0.6263
91655427|NCT00076102|183203679|OTHER|||||||0.3625|||||||ANOVA|||F= 0.87 under the null hypothesis||||0.3625
91655428|NCT00076102|183203679|OTHER|||||||0.5877|||||||ANOVA|||F=0.31 under the null hypothesis||||0.5877
91655429|NCT00076102|183203679|OTHER|||||||0.2767|||||||ANOVA|||F=1.27 under the null hypothesis||||0.2767
91655430|NCT00076102|183203679|OTHER|||||||0.8466|||||||ANOVA|||F=0.04 under the null hypothesis||||0.8466
91655431|NCT00076102|183203679|OTHER|||||||0.6774|||||||ANOVA|||F=0.18 under the null hypothesis||||0.6774
91655432|NCT00414466|183203699|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.802
91655433|NCT00414466|183203699|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.874
91711197|NCT03365934|183314482|SUPERIORITY|||||||0.078046|||||||t-test, 2 sided|||||||0.078046
91614243|NCT01345786|183122468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|108.1||||||90.0|104.7|111.6|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUC infinity||111.6|104.7|
91711198|NCT03365934|183314482|SUPERIORITY|||||||0.054975|||||||t-test, 2 sided|||||||0.054975
91655434|NCT00414466|183203699|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.899
91527407|NCT02354859|182930010|SUPERIORITY||Mean Difference (Final Values)|4.23||||0.053|TWO_SIDED|95.0|-0.06|8.53|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline CFRSD-CRISS score, treatment, visit and a visit-by-visit interaction.|||8.53|-0.06|0.053
91614244|NCT01345786|183122468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.1||||||90.0|100.5|105.8|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC infinity||105.8|100.5|
91655435|NCT00414466|183203700|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
91655436|NCT00414466|183203700|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
91655437|NCT00414466|183203700|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
91655438|NCT00414466|183203701|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.083
91655439|NCT00414466|183203701|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||1.000
91655440|NCT00414466|183203701|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.352
91655441|NCT05920161|183203702|SUPERIORITY|||||||0.023|||||||t-test, 1 sided|||||||0.023
91655442|NCT05920161|183203702|SUPERIORITY|||||||0.068|||||||t-test, 1 sided|||||||0.068
91655443|NCT05920161|183203703|SUPERIORITY|||||||0.281|||||||t-test, 1 sided|||Within-group A - B (null \>0)||||0.281
91655444|NCT05920161|183203703|SUPERIORITY|||||||0.645|||||||t-test, 1 sided|||Within-group A - B (null \>0)||||0.645
91655445|NCT05920161|183203703|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Between-group comparison||||0.245
91655446|NCT05920161|183203704|SUPERIORITY|||||||0.143|||||||t-test, 1 sided|||||||0.143
91655447|NCT05920161|183203704|SUPERIORITY|||||||0.797||||||above chance 0.5|t-test, 1 sided|||||||0.797
91655448|NCT05920161|183203704|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
91655449|NCT05920161|183203705|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||A condition||||<0.0001
91655450|NCT05920161|183203705|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||B condition||||<0.0001
91655451|NCT05920161|183203705|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||X condition||||<0.0001
91655452|NCT05920161|183203706|SUPERIORITY||||||<|0|||||||t-test, 1 sided|||||||< 0.000
91655453|NCT05920161|183203706|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
91655454|NCT05920161|183203707|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|||||||0.083
91655455|NCT05920161|183203707|SUPERIORITY|||||||0.088|||||||t-test, 1 sided|||||||0.088
91655456|NCT02016300|183203715|OTHER|||||||0.162|||||||Regression, Linear|||Difference between baseline and month 6.||||0.162
91655457|NCT02016300|183203715|OTHER|||||||0.094|||||||Regression, Linear|||Difference between baseline and month 12.||||0.094
91655458|NCT02016300|183203715|OTHER|||||||0.043|||||||Regression, Linear|||Difference between baseline and month 24.||||0.043
91655459|NCT02016300|183203716|OTHER|||||||0.387|||||||Regression, Linear|||Difference between baseline and month 6.||||0.387
91655460|NCT02016300|183203716|OTHER|||||||0.34|||||||Regression, Linear|||Difference between baseline and month 12.||||0.340
91655461|NCT02016300|183203716|OTHER|||||||0.179|||||||Regression, Linear|||Difference between baseline and month 24.||||0.179
91655462|NCT02016300|183203717|OTHER|||||||0.729|||||||Regression, Linear|||Difference between baseline and month 6.||||0.729
91655463|NCT02016300|183203717|OTHER|||||||0.958|||||||Regression, Linear|||Difference between baseline and month 12.||||0.958
91655464|NCT02016300|183203717|OTHER|||||||0.634|||||||Regression, Linear|||Difference between baseline and month 24.||||0.634
91655465|NCT02016300|183203718|OTHER|||||||0.733|||||||Regression, Linear|||Difference between baseline and month 6.||||0.733
91655466|NCT02016300|183203718|OTHER|||||||0.666|||||||Regression, Linear|||Difference between baseline and month 12.||||0.666
91655467|NCT02016300|183203718|OTHER|||||||0.854|||||||Regression, Linear|||Difference between baseline and month 24.||||0.854
91655468|NCT02016300|183203719|OTHER|||||||0.774|||||||Regression, Linear|||Difference between baseline and month 12.||||0.774
91655469|NCT02016300|183203719|OTHER|||||||0.414|||||||Regression, Linear|||Difference between baseline and month 24.||||0.414
91655470|NCT02016300|183203720|OTHER|||||||0.064|||||||Regression, Linear|||Difference between baseline and month 12.||||0.064
91655471|NCT02016300|183203720|OTHER|||||||0.276|||||||Regression, Linear|||Difference between baseline and month 24.||||0.276
91655472|NCT02016300|183203721|OTHER|||||||0.02|||||||Regression, Linear|||Difference between baseline and month 12.||||0.020
91655473|NCT02016300|183203721|OTHER|||||||0.091|||||||Regression, Linear|||Difference between baseline and month 24.||||0.091
91711199|NCT03365934|183314482|SUPERIORITY|||||||0.050132|||||||t-test, 2 sided|||||||0.050132
91711200|NCT03365934|183314482|SUPERIORITY|||||||0.034793|||||||t-test, 2 sided|||||||0.034793
91711201|NCT03365934|183314482|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
91711202|NCT03365934|183314483|SUPERIORITY|||||||0.997406|||||||t-test, 2 sided|||||||0.997406
91711203|NCT03365934|183314483|SUPERIORITY|||||||0.354187|||||||t-test, 2 sided|||||||0.354187
91655474|NCT00655642|183203722|NON_INFERIORITY_OR_EQUIVALENCE|Based on the aforementioned values, we calculated a sample size for each treatment arm of 131 patients. We increased this sample estimate to 150 per treatment arm (total of 600 patients) to account for anticipated study attrition. Based on an unplanned interim conditional power futility analysis done at 30% information fraction, the decision was made to end the trial early.The futility analysis found the observed differences were far less than what was deemed clinically important.|Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0||0.16||||||Being aware of the multiple comparison issues, we deliberately chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|Kruskal-Wallis|We computed the effect of the 3 treatments relative to ondansetron.|Change in VAS score was calculated as (VAS 30 min - VAS baseline). We calculated the differences in median VAS reductions for each arm relative to ondansetron.|The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.||||0.16
91655475|NCT01546987|183203732|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|95.0|0.47|1.48||One-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that seventy events with five years of additional follow-up after early accrual closure provides 70% power (at one-sided alpha = 0.05) to detect a 40% reduction in the assumed rate control arm rate of is 0.08/year.||1.48|0.47|0.55
91655476|NCT01546987|183203733|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.27|TWO_SIDED|95.0|0.38|1.31||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.055 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 28% power (at two-sided alpha = 0.05) to detect a 33% reduction in failure rate.||1.31|0.38|0.27
91655477|NCT01546987|183203734|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.001|TWO_SIDED|95.0|1.54|3.4|||Log Rank||Reference level = ADT + RT arm|||3.40|1.54|<0.001
91711204|NCT03365934|183314483|SUPERIORITY|||||||0.883222|||||||t-test, 2 sided|||||||0.883222
91711205|NCT03365934|183314483|SUPERIORITY|||||||0.000412|||||||t-test, 2 sided|||||||0.000412
91711206|NCT03365934|183314483|SUPERIORITY|||||||0.000332|||||||t-test, 2 sided|||||||0.000332
91655478|NCT01546987|183203735|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13|||Log Rank|||||3.13|0.33|0.99
91655479|NCT01546987|183203736|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.48|TWO_SIDED|95.0|0.29|1.75||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT arm|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.02 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 32% power (at two-sided alpha = 0.05) to detect a 50% reduction in failure rate.||1.75|0.29|0.48
91711207|NCT03365934|183314483|SUPERIORITY|||||||0.626878|||||||t-test, 2 sided|||||||0.626878
91655480|NCT01546987|183203737|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.65|TWO_SIDED|95.0|0.45|1.63||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|||1.63|0.45|0.65
91711208|NCT03365934|183314483|SUPERIORITY|||||||0.984465|||||||t-test, 2 sided|||||||0.984465
91711209|NCT03365934|183314483|SUPERIORITY|||||||0.001845|||||||t-test, 2 sided|||||||0.001845
91711210|NCT03365934|183314483|SUPERIORITY|||||||0.001507|||||||t-test, 2 sided|||||||0.001507
91711211|NCT03365934|183314483|SUPERIORITY|||||||0.970029|||||||t-test, 2 sided|||||||0.970029
91711212|NCT03365934|183314483|SUPERIORITY|||||||0.19886|||||||t-test, 2 sided|||||||0.19886
91711213|NCT03365934|183314483|SUPERIORITY|||||||0.177549|||||||t-test, 2 sided|||||||0.177549
91711214|NCT03365934|183314483|SUPERIORITY|||||||0.041698|||||||t-test, 2 sided|||||||0.041698
91711215|NCT03365934|183314483|SUPERIORITY|||||||0.036131|||||||t-test, 2 sided|||||||0.036131
91711216|NCT03365934|183314483|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91711217|NCT03365934|183314484|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91711218|NCT03365934|183314484|SUPERIORITY|||||||0.317315|||||||t-test, 2 sided|||||||0.317315
91711219|NCT03365934|183314484|SUPERIORITY|||||||0.829352|||||||t-test, 2 sided|||||||0.829352
91711220|NCT03365934|183314484|SUPERIORITY|||||||0.010561|||||||t-test, 2 sided|||||||0.010561
91711221|NCT03365934|183314484|SUPERIORITY|||||||0.001099|||||||t-test, 2 sided|||||||0.001099
91711222|NCT03365934|183314484|SUPERIORITY|||||||0.175148|||||||t-test, 2 sided|||||||0.175148
91711223|NCT03365934|183314484|SUPERIORITY|||||||0.728796|||||||t-test, 2 sided|||||||0.728796
91711224|NCT03365934|183314484|SUPERIORITY|||||||0.001992|||||||t-test, 2 sided|||||||0.001992
91711225|NCT03365934|183314484|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
91711226|NCT03365934|183314484|SUPERIORITY|||||||0.974567|||||||t-test, 2 sided|||||||0.974567
91711227|NCT03365934|183314484|SUPERIORITY|||||||0.668933|||||||t-test, 2 sided|||||||0.668933
91711228|NCT03365934|183314484|SUPERIORITY|||||||0.239446|||||||t-test, 2 sided|||||||0.239446
91711229|NCT03365934|183314484|SUPERIORITY|||||||0.283848|||||||t-test, 2 sided|||||||0.283848
91711230|NCT03365934|183314484|SUPERIORITY|||||||0.06829|||||||t-test, 2 sided|||||||0.06829
91711231|NCT03365934|183314484|SUPERIORITY|||||||0.979516|||||||t-test, 2 sided|||||||0.979516
91711232|NCT03365934|183314485|SUPERIORITY|||||||0.996522|||||||t-test, 2 sided|||||||0.996522
91711233|NCT03365934|183314485|SUPERIORITY|||||||0.875832|||||||t-test, 2 sided|||||||0.875832
91711234|NCT03365934|183314485|SUPERIORITY|||||||0.938|||||||t-test, 2 sided|||||||0.938
91711235|NCT03365934|183314485|SUPERIORITY|||||||0.038527|||||||t-test, 2 sided|||||||0.038527
91711236|NCT03365934|183314485|SUPERIORITY|||||||0.018334|||||||t-test, 2 sided|||||||0.018334
91711237|NCT03365934|183314485|SUPERIORITY|||||||0.512209|||||||t-test, 2 sided|||||||0.512209
91711238|NCT03365934|183314485|SUPERIORITY|||||||0.665529|||||||t-test, 2 sided|||||||0.665529
91711239|NCT03365934|183314485|SUPERIORITY|||||||0.002257|||||||t-test, 2 sided|||||||0.002257
91711240|NCT03365934|183314485|SUPERIORITY|||||||0.000728|||||||t-test, 2 sided|||||||0.000728
91711241|NCT03365934|183314485|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
91711242|NCT03365934|183314485|SUPERIORITY|||||||0.417914|||||||t-test, 2 sided|||||||0.417914
91614245|NCT01345786|183122469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.5||||||90.0|96.7|106.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||106.4|96.7|
91614246|NCT01345786|183122469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.3||||||90.0|98.1|104.7|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||104.7|98.1|
91614247|NCT02986958|183122481|OTHER|We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
91655481|NCT01546987|183203739|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.76
91655482|NCT01546987|183203740|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||\[Bowel domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.44
91655483|NCT01546987|183203740|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||\[Urinary domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.13
91655484|NCT01546987|183203740|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||\[Sexual domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.50
91655485|NCT01546987|183203740|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||\[Hormonal domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.96
91655486|NCT01546987|183203751|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0104|TWO_SIDED|95.0|0.29|0.89|||Log Rank||Reference arm = ADT + RT arm|||0.89|0.29|0.0104
91655487|NCT02270736|183203753|SUPERIORITY||Least square mean (LS-mean) difference|-0.06|STANDARD_ERROR_OF_MEAN|0.019|=|0.0012|TWO_SIDED|95.0|-0.1|-0.03|||MMRM|||Least square mean (LS-Mean) is from a mixed model repeated measurement (MMRM) analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.03|-0.1|= 0.0012
91614248|NCT02260193|183122493|SUPERIORITY||Least Squares Mean Differences|0.29|||||TWO_SIDED|95.0|-0.25|0.82||||||||0.82|-0.25|
91711243|NCT03365934|183314485|SUPERIORITY|||||||0.277469|||||||t-test, 2 sided|||||||0.277469
91711244|NCT03365934|183314485|SUPERIORITY|||||||0.385419|||||||t-test, 2 sided|||||||0.385419
91614249|NCT02260193|183122493|SUPERIORITY||Least Squares Mean Differences|0.36|||||TWO_SIDED|95.0|-0.19|0.9||||||||0.90|-0.19|
91614250|NCT02260193|183122493|SUPERIORITY||Least Squares Mean Differences|0.07|||||TWO_SIDED|95.0|-0.48|0.61||||||||0.61|-0.48|
91614251|NCT02260193|183122494|SUPERIORITY||Least Squares Mean Differences|0.04|||||TWO_SIDED|95.0|-0.54|0.61||||||||0.61|-0.54|
91614252|NCT02260193|183122494|SUPERIORITY||Least Squares Mean Differences|0.1|||||TWO_SIDED|95.0|-0.49|0.7||||||||0.70|-0.49|
91614253|NCT02260193|183122494|SUPERIORITY||Least squares mean difference|0.07|||||TWO_SIDED|95.0|-0.53|0.66||||||||0.66|-0.53|
91614254|NCT02260193|183122495|SUPERIORITY||Least squares mean difference|-0.34|||||TWO_SIDED|95.0|-0.71|0.04||||||||0.04|-0.71|
91614255|NCT02260193|183122495|SUPERIORITY||Least squares mean difference|-0.11|||||TWO_SIDED|95.0|-0.5|0.29||||||||0.29|-0.50|
91614256|NCT02260193|183122495|SUPERIORITY||Least squares mean difference|0.23|||||TWO_SIDED|95.0|-0.16|0.62||||||||0.62|-0.16|
91614257|NCT01000064|183122588|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.053
91614258|NCT01000064|183122589|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.052
91614259|NCT01000064|183122590|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
91614260|NCT01000064|183122591|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
91614261|NCT01000064|183122592|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
91614262|NCT01000064|183122593|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.040
91614263|NCT01000064|183122594|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
91711245|NCT03365934|183314485|SUPERIORITY|||||||0.257647|||||||t-test, 2 sided|||||||0.257647
91711246|NCT03365934|183314485|SUPERIORITY|||||||0.999897|||||||t-test, 2 sided|||||||0.999897
91711247|NCT03365934|183314486|SUPERIORITY|||||||0.862516|||||||t-test, 2 sided|||||||0.862516
91711248|NCT03365934|183314486|SUPERIORITY|||||||0.00473|||||||t-test, 2 sided|||||||0.00473
91711249|NCT03365934|183314486|SUPERIORITY|||||||0.085238|||||||t-test, 2 sided|||||||0.085238
91711250|NCT03365934|183314486|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711251|NCT03365934|183314486|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91711252|NCT03365934|183314486|SUPERIORITY|||||||0.168409|||||||t-test, 2 sided|||||||0.168409
91711253|NCT03365934|183314486|SUPERIORITY|||||||0.652654|||||||t-test, 2 sided|||||||0.652654
91711254|NCT03365934|183314486|SUPERIORITY|||||||0.001436|||||||t-test, 2 sided|||||||0.001436
91711255|NCT03365934|183314486|SUPERIORITY|||||||0.000235|||||||t-test, 2 sided|||||||0.000235
91711256|NCT03365934|183314486|SUPERIORITY|||||||0.974842|||||||t-test, 2 sided|||||||0.974842
91524196|NCT04843930|182923534|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 229.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.79
91614264|NCT01377467|183122615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.059|STANDARD_ERROR_OF_MEAN|0.967|<|0.001|TWO_SIDED|95.0|3.137|6.98|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.||6.980|3.137|<0.001
91614265|NCT01377467|183122616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.895|STANDARD_ERROR_OF_MEAN|0.887||0.035|TWO_SIDED|95.0|0.132|3.659|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.659|0.132|0.035
91614266|NCT01377467|183122617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.059|STANDARD_ERROR_OF_MEAN|1.201||0.38|TWO_SIDED|95.0|-1.329|3.447|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.447|-1.329|0.380
91614267|NCT01377467|183122618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.567|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|2.975|6.178|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||6.178|2.975|<0.001
91614268|NCT01377467|183122619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.756|STANDARD_ERROR_OF_MEAN|0.662||0.009|TWO_SIDED|95.0|0.44|3.072|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.072|0.440|0.009
91614269|NCT01377467|183122620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.035|STANDARD_ERROR_OF_MEAN|1.085||0.064|TWO_SIDED|95.0|-0.122|4.193|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||4.193|-0.122|0.064
91655488|NCT02270736|183203754|SUPERIORITY||Least square mean (LS-mean) difference|0.28|STANDARD_ERROR_OF_MEAN|0.127|=|0.032|TWO_SIDED|95.0|0.02|0.53|||MMRM|||LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline Modified Teacher Drooling Scale (mTDS) score as covariate.||0.53|0.02|= 0.032
91527702|NCT01976364|182930497|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-0.6|
91614270|NCT01377467|183122621|SUPERIORITY_OR_OTHER||between-subjects effect|10.466|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p=0.007. Time\*treatment interaction: p=0.002. The a priori threshold for statistical significance is \<0.05.|||||<0.001
91614271|NCT01377467|183122622|SUPERIORITY_OR_OTHER||between-subjects effect|275622.016|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.012. The a priori threshold for statistical significance is \<0.05.|||||<0.001
91614272|NCT01377467|183122623|SUPERIORITY_OR_OTHER||between-subjects effect|0.717||||0.014|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p\<0.001. The a priori threshold for statistical significance is \<0.05.|||||0.014
91614273|NCT01377467|183122624|SUPERIORITY_OR_OTHER||between-subjects effect|0.707||||0.068|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.068
91614274|NCT01377467|183122625|SUPERIORITY_OR_OTHER||between-subjects effect|99952.126||||0.114|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.114
91614275|NCT01377467|183122626|SUPERIORITY_OR_OTHER||between-subjects effect|84.83||||0.578|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.593. The a priori threshold for statistical significance is \<0.05.|||||0.578
91614276|NCT01377467|183122627|SUPERIORITY_OR_OTHER||between-subjects effect|248.686||||0.607|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.296. The a priori threshold for statistical significance is \<0.05.|||||0.607
91614277|NCT01377467|183122628|SUPERIORITY_OR_OTHER||z value|-2.342||||0.019|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.019
91614278|NCT01377467|183122629|SUPERIORITY_OR_OTHER||z value|-2.049||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
91614279|NCT01377467|183122630|SUPERIORITY_OR_OTHER||z value|-0.937||||0.371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.371
91614280|NCT01377467|183122631|SUPERIORITY_OR_OTHER||z value|-2.752||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
91614281|NCT01377467|183122632|SUPERIORITY_OR_OTHER||z value|-2.166||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
91614282|NCT01377467|183122633|SUPERIORITY_OR_OTHER||z value|-1.288||||0.212|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.212
91614283|NCT01377467|183122634|SUPERIORITY_OR_OTHER||z value|-1.64||||0.108|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.108
91614284|NCT01377467|183122635|SUPERIORITY_OR_OTHER||z value|-1.991||||0.048|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.048
91711257|NCT03365934|183314486|SUPERIORITY|||||||0.557877|||||||t-test, 2 sided|||||||0.557877
91711258|NCT03365934|183314486|SUPERIORITY|||||||0.277244|||||||t-test, 2 sided|||||||0.277244
91524197|NCT04843930|182923535|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.45|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 269.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.45
91655489|NCT02270736|183203756|SUPERIORITY||Least square mean (LS-mean) difference|-0.09|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|-0.12|-0.05|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.05|-0.12|<0.0001
91655490|NCT02270736|183203756|SUPERIORITY||Least square mean (LS-mean) difference|-0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|-0.14|-0.06|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.06|-0.14|<0.0001
91655491|NCT02270736|183203757|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.116|=|0.0008|TWO_SIDED|95.0|0.17|0.63|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.63|0.17|=0.0008
91655492|NCT02270736|183203757|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.132|=|0.0026|TWO_SIDED|95.0|0.14|0.66|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.66|0.14|=0.0026
91655493|NCT00262600|183203762|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.9|||<|0.0001||95.0|0.74|1.1||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 110 mg to warfarin||1.10|0.74|<.0001
91655494|NCT00262600|183203762|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.65|||<|0.0001||95.0|0.52|0.81||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 150 mg to warfarin||0.81|0.52|<.0001
91655495|NCT00262600|183203763|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.2206||95.0|0.83|1.04||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.04|0.83|0.2206
91655496|NCT00262600|183203763|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.0015||95.0|0.74|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.93|0.74|0.0015
91655497|NCT00262600|183203764|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.7508||95.0|0.87|1.11||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.11|0.87|0.7508
91655498|NCT00262600|183203764|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.0093||95.0|0.74|0.96||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.96|0.74|0.0093
91655499|NCT00262600|183203765|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0026||95.0|0.7|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||0.93|0.70|0.0026
91655500|NCT00262600|183203765|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.3146||95.0|0.81|1.07||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||1.07|0.81|0.3146
91655501|NCT00262600|183203766|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.3|||<|0.0001||95.0|0.19|0.45||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.45|0.19|<0.0001
91655502|NCT00262600|183203766|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.41|||<|0.0001||95.0|0.28|0.6||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.60|0.28|<0.0001
91655503|NCT04908748|183203780|SUPERIORITY||Least squares mean difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-32.2|-26.0|||ANCOVA|||||-26.0|-32.2|< 0.0001
91655504|NCT00721409|183203862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.488||||0.0004|TWO_SIDED|95.0|0.319|0.748||1-sided p-value from the log-rank test stratified by stratification factors per randomization and Part.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Stratified analysis was presented above.||0.748|0.319|0.0004
91655505|NCT00721409|183203862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.572|0.156|<0.0001
91655506|NCT00721409|183203862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.508||||0.0046|TWO_SIDED|95.0|0.303|0.853||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.853|0.303|0.0046
91711259|NCT03365934|183314486|SUPERIORITY|||||||0.195527|||||||t-test, 2 sided|||||||0.195527
91711260|NCT03365934|183314486|SUPERIORITY|||||||0.070843|||||||t-test, 2 sided|||||||0.070843
91524198|NCT04843930|182923536|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.02|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 236.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.02
91524199|NCT04843930|182923537|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.96|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 257.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.96
91524200|NCT04843930|182923538|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 262.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
91524201|NCT04843930|182923539|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.6|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 227.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.60
91524202|NCT04843930|182923540|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.06|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 89.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.06
91527703|NCT01976364|182930497|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7|-0.3|
91711261|NCT03365934|183314486|SUPERIORITY|||||||0.997565|||||||t-test, 2 sided|||||||0.997565
91711262|NCT03365934|183314487|SUPERIORITY|||||||0.016628|||||||t-test, 2 sided|||||||0.016628
91711263|NCT03365934|183314487|SUPERIORITY|||||||0.217862|||||||t-test, 2 sided|||||||0.217862
91711264|NCT03365934|183314487|SUPERIORITY|||||||0.812915|||||||t-test, 2 sided|||||||0.812915
91711265|NCT03365934|183314487|SUPERIORITY|||||||0.999971|||||||t-test, 2 sided|||||||0.999971
91711266|NCT03365934|183314487|SUPERIORITY|||||||0.275557|||||||t-test, 2 sided|||||||0.275557
91711267|NCT03365934|183314487|SUPERIORITY|||||||0.870124|||||||t-test, 2 sided|||||||0.870124
91711268|NCT03365934|183314487|SUPERIORITY|||||||0.380144|||||||t-test, 2 sided|||||||0.380144
91711269|NCT03365934|183314487|SUPERIORITY|||||||0.029518|||||||t-test, 2 sided|||||||0.029518
91711270|NCT03365934|183314487|SUPERIORITY|||||||0.815476|||||||t-test, 2 sided|||||||0.815476
91711271|NCT03365934|183314487|SUPERIORITY|||||||0.944307|||||||t-test, 2 sided|||||||0.944307
91711272|NCT03365934|183314487|SUPERIORITY|||||||0.313389|||||||t-test, 2 sided|||||||0.313389
91711273|NCT03365934|183314487|SUPERIORITY|||||||0.999996|||||||t-test, 2 sided|||||||0.999996
91711274|NCT03365934|183314487|SUPERIORITY|||||||0.894272|||||||t-test, 2 sided|||||||0.894272
91711275|NCT03365934|183314487|SUPERIORITY|||||||0.969093|||||||t-test, 2 sided|||||||0.969093
91711276|NCT03365934|183314487|SUPERIORITY|||||||0.383434|||||||t-test, 2 sided|||||||0.383434
91711277|NCT03365934|183314488|SUPERIORITY|||||||0.393119|||||||t-test, 2 sided|||||||0.393119
91711278|NCT03365934|183314488|SUPERIORITY|||||||0.890335|||||||t-test, 2 sided|||||||0.890335
91711279|NCT03365934|183314488|SUPERIORITY|||||||0.021978|||||||t-test, 2 sided|||||||0.021978
91711280|NCT03365934|183314488|SUPERIORITY|||||||0.000983|||||||t-test, 2 sided|||||||0.000983
91711281|NCT03365934|183314488|SUPERIORITY|||||||0.006615|||||||t-test, 2 sided|||||||0.006615
91711282|NCT03365934|183314488|SUPERIORITY|||||||0.951883|||||||t-test, 2 sided|||||||0.951883
91711283|NCT03365934|183314488|SUPERIORITY|||||||0.692455|||||||t-test, 2 sided|||||||0.692455
91711284|NCT03365934|183314488|SUPERIORITY|||||||0.257254|||||||t-test, 2 sided|||||||0.257254
91711285|NCT03365934|183314488|SUPERIORITY|||||||0.530181|||||||t-test, 2 sided|||||||0.530181
91711286|NCT03365934|183314488|SUPERIORITY|||||||0.219274|||||||t-test, 2 sided|||||||0.219274
91711287|NCT03365934|183314488|SUPERIORITY|||||||0.029675|||||||t-test, 2 sided|||||||0.029675
91711288|NCT03365934|183314488|SUPERIORITY|||||||0.111454|||||||t-test, 2 sided|||||||0.111454
91527408|NCT01003184|182930045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6|||<|0.0001|TWO_SIDED|95.0|3.17|13.73|||Regression, Logistic|Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.||"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.~Sample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference."||13.73|3.17|<.0001
91655507|NCT00721409|183203875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.897||||0.2812|TWO_SIDED|95.0|0.623|1.294||1-sided p-value from the log-rank test stratified by Part (α = 0.10).|Log Rank|||Stratified analysis was presented above. Hazard ratio was assuming proportional hazards, a hazard ratio less than 1 indicated a reduction in hazard rate in favor of palbociclib + letrozole.||1.294|0.623|0.2812
91655508|NCT00721409|183203875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.837||||0.2803|TWO_SIDED|95.0|0.458|1.527||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.527|0.458|0.2803
91655509|NCT00721409|183203875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.935||||0.3875|TWO_SIDED|95.0|0.59|1.48||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.480|0.590|0.3875
91711289|NCT03365934|183314488|SUPERIORITY|||||||0.995849|||||||t-test, 2 sided|||||||0.995849
91711290|NCT03365934|183314488|SUPERIORITY|||||||0.999994|||||||t-test, 2 sided|||||||0.999994
91711291|NCT03365934|183314488|SUPERIORITY|||||||0.998744|||||||t-test, 2 sided|||||||0.998744
91711292|NCT03365934|183314489|SUPERIORITY|||||||0.999858|||||||t-test, 2 sided|||||||0.999858
91711293|NCT03365934|183314489|SUPERIORITY|||||||0.215132|||||||t-test, 2 sided|||||||0.215132
91711294|NCT03365934|183314489|SUPERIORITY|||||||0.958812|||||||t-test, 2 sided|||||||0.958812
91711295|NCT03365934|183314489|SUPERIORITY|||||||0.00622|||||||t-test, 2 sided|||||||0.00622
91711296|NCT03365934|183314489|SUPERIORITY|||||||0.017733|||||||t-test, 2 sided|||||||0.017733
91711297|NCT03365934|183314489|SUPERIORITY|||||||0.330576|||||||t-test, 2 sided|||||||0.330576
91711298|NCT03365934|183314489|SUPERIORITY|||||||0.990334|||||||t-test, 2 sided|||||||0.990334
91711299|NCT03365934|183314489|SUPERIORITY|||||||0.013025|||||||t-test, 2 sided|||||||0.013025
91711300|NCT03365934|183314489|SUPERIORITY|||||||0.034707|||||||t-test, 2 sided|||||||0.034707
91711301|NCT03365934|183314489|SUPERIORITY|||||||0.771698|||||||t-test, 2 sided|||||||0.771698
91711302|NCT03365934|183314489|SUPERIORITY|||||||0.790117|||||||t-test, 2 sided|||||||0.790117
91711303|NCT03365934|183314489|SUPERIORITY|||||||0.923224|||||||t-test, 2 sided|||||||0.923224
91711304|NCT03365934|183314489|SUPERIORITY|||||||0.112245|||||||t-test, 2 sided|||||||0.112245
91711305|NCT03365934|183314489|SUPERIORITY|||||||0.216229|||||||t-test, 2 sided|||||||0.216229
91711306|NCT03365934|183314489|SUPERIORITY|||||||0.999663|||||||t-test, 2 sided|||||||0.999663
91711307|NCT03365934|183314490|SUPERIORITY|||||||0.91874|||||||t-test, 2 sided|||||||0.91874
91711308|NCT03365934|183314490|SUPERIORITY|||||||0.013582|||||||t-test, 2 sided|||||||0.013582
91711309|NCT03365934|183314490|SUPERIORITY|||||||0.523284|||||||t-test, 2 sided|||||||0.523284
91711310|NCT03365934|183314490|SUPERIORITY|||||||0.000315|||||||t-test, 2 sided|||||||0.000315
91711311|NCT03365934|183314490|SUPERIORITY|||||||0.059485|||||||t-test, 2 sided|||||||0.059485
91711312|NCT03365934|183314490|SUPERIORITY|||||||0.15037|||||||t-test, 2 sided|||||||0.15037
91711313|NCT03365934|183314490|SUPERIORITY|||||||0.967277|||||||t-test, 2 sided|||||||0.967277
91711314|NCT03365934|183314490|SUPERIORITY|||||||0.008729|||||||t-test, 2 sided|||||||0.008729
91711315|NCT03365934|183314490|SUPERIORITY|||||||0.421603|||||||t-test, 2 sided|||||||0.421603
91711316|NCT03365934|183314490|SUPERIORITY|||||||0.647267|||||||t-test, 2 sided|||||||0.647267
91711317|NCT03365934|183314490|SUPERIORITY|||||||0.953645|||||||t-test, 2 sided|||||||0.953645
91711318|NCT03365934|183314490|SUPERIORITY|||||||0.987387|||||||t-test, 2 sided|||||||0.987387
91711319|NCT03365934|183314490|SUPERIORITY|||||||0.147361|||||||t-test, 2 sided|||||||0.147361
91711320|NCT03365934|183314490|SUPERIORITY|||||||0.930371|||||||t-test, 2 sided|||||||0.930371
91711321|NCT03365934|183314490|SUPERIORITY|||||||0.6094|||||||t-test, 2 sided|||||||0.6094
91711322|NCT03365934|183314491|SUPERIORITY|||||||0.99253|||||||t-test, 2 sided|||||||0.99253
91711323|NCT03365934|183314491|SUPERIORITY|||||||0.795279|||||||t-test, 2 sided|||||||0.795279
91711324|NCT03365934|183314491|SUPERIORITY|||||||0.855067|||||||t-test, 2 sided|||||||0.855067
91711325|NCT03365934|183314491|SUPERIORITY|||||||0.003915|||||||t-test, 2 sided|||||||0.003915
91711326|NCT03365934|183314491|SUPERIORITY|||||||0.000221|||||||t-test, 2 sided|||||||0.000221
91711327|NCT03365934|183314491|SUPERIORITY|||||||0.97816|||||||t-test, 2 sided|||||||0.97816
91711328|NCT03365934|183314491|SUPERIORITY|||||||0.98972|||||||t-test, 2 sided|||||||0.98972
91711329|NCT03365934|183314491|SUPERIORITY|||||||0.01764|||||||t-test, 2 sided|||||||0.01764
91711330|NCT03365934|183314491|SUPERIORITY|||||||0.001185|||||||t-test, 2 sided|||||||0.001185
91711331|NCT03365934|183314491|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
91711332|NCT03365934|183314491|SUPERIORITY|||||||0.119961|||||||t-test, 2 sided|||||||0.119961
91711333|NCT03365934|183314491|SUPERIORITY|||||||0.013468|||||||t-test, 2 sided|||||||0.013468
91711334|NCT03365934|183314491|SUPERIORITY|||||||0.112192|||||||t-test, 2 sided|||||||0.112192
91711335|NCT03365934|183314491|SUPERIORITY|||||||0.013135|||||||t-test, 2 sided|||||||0.013135
91711336|NCT03365934|183314491|SUPERIORITY|||||||0.965966|||||||t-test, 2 sided|||||||0.965966
91711337|NCT03365934|183314492|SUPERIORITY|||||||0.968005|||||||t-test, 2 sided|||||||0.968005
91711338|NCT03365934|183314492|SUPERIORITY|||||||0.526293|||||||t-test, 2 sided|||||||0.526293
91711339|NCT03365934|183314492|SUPERIORITY|||||||0.994384|||||||t-test, 2 sided|||||||0.994384
91711340|NCT03365934|183314492|SUPERIORITY|||||||0.004967|||||||t-test, 2 sided|||||||0.004967
91711341|NCT03365934|183314492|SUPERIORITY|||||||0.000948|||||||t-test, 2 sided|||||||0.000948
91711342|NCT03365934|183314492|SUPERIORITY|||||||0.936394|||||||t-test, 2 sided|||||||0.936394
91711343|NCT03365934|183314492|SUPERIORITY|||||||0.999945|||||||t-test, 2 sided|||||||0.999945
91711344|NCT03365934|183314492|SUPERIORITY|||||||0.050032|||||||t-test, 2 sided|||||||0.050032
91711345|NCT03365934|183314492|SUPERIORITY|||||||0.01256|||||||t-test, 2 sided|||||||0.01256
91711346|NCT03365934|183314492|SUPERIORITY|||||||0.886978|||||||t-test, 2 sided|||||||0.886978
91711347|NCT03365934|183314492|SUPERIORITY|||||||0.391295|||||||t-test, 2 sided|||||||0.391295
91711348|NCT03365934|183314492|SUPERIORITY|||||||0.163678|||||||t-test, 2 sided|||||||0.163678
91711349|NCT03365934|183314492|SUPERIORITY|||||||0.047937|||||||t-test, 2 sided|||||||0.047937
91711350|NCT03365934|183314492|SUPERIORITY|||||||0.013231|||||||t-test, 2 sided|||||||0.013231
91711351|NCT03365934|183314492|SUPERIORITY|||||||0.996358|||||||t-test, 2 sided|||||||0.996358
91711352|NCT03365934|183314493|SUPERIORITY|||||||0.995862|||||||t-test, 2 sided|||||||0.995862
91711353|NCT03365934|183314493|SUPERIORITY|||||||0.223341|||||||t-test, 2 sided|||||||0.223341
91711354|NCT03365934|183314493|SUPERIORITY|||||||0.834338|||||||t-test, 2 sided|||||||0.834338
91711355|NCT03365934|183314493|SUPERIORITY|||||||0.030267|||||||t-test, 2 sided|||||||0.030267
91711356|NCT03365934|183314493|SUPERIORITY|||||||0.00104|||||||t-test, 2 sided|||||||0.00104
91711357|NCT03365934|183314493|SUPERIORITY|||||||0.377217|||||||t-test, 2 sided|||||||0.377217
91711358|NCT03365934|183314493|SUPERIORITY|||||||0.965547|||||||t-test, 2 sided|||||||0.965547
91711359|NCT03365934|183314493|SUPERIORITY|||||||0.052284|||||||t-test, 2 sided|||||||0.052284
91711360|NCT03365934|183314493|SUPERIORITY|||||||0.001348|||||||t-test, 2 sided|||||||0.001348
91711361|NCT03365934|183314493|SUPERIORITY|||||||0.927936|||||||t-test, 2 sided|||||||0.927936
91711362|NCT03365934|183314493|SUPERIORITY|||||||0.946487|||||||t-test, 2 sided|||||||0.946487
91711363|NCT03365934|183314493|SUPERIORITY|||||||0.327918|||||||t-test, 2 sided|||||||0.327918
91711364|NCT03365934|183314493|SUPERIORITY|||||||0.475038|||||||t-test, 2 sided|||||||0.475038
91711365|NCT03365934|183314493|SUPERIORITY|||||||0.060057|||||||t-test, 2 sided|||||||0.060057
91711366|NCT03365934|183314493|SUPERIORITY|||||||0.857177|||||||t-test, 2 sided|||||||0.857177
91711367|NCT03365934|183314494|SUPERIORITY|||||||0.999997|||||||t-test, 2 sided|||||||0.999997
91711368|NCT03365934|183314494|SUPERIORITY|||||||0.938793|||||||t-test, 2 sided|||||||0.938793
91711369|NCT03365934|183314494|SUPERIORITY|||||||0.965993|||||||t-test, 2 sided|||||||0.965993
91711370|NCT03365934|183314494|SUPERIORITY|||||||0.057803|||||||t-test, 2 sided|||||||0.057803
91711371|NCT03365934|183314494|SUPERIORITY|||||||0.022816|||||||t-test, 2 sided|||||||0.022816
91711372|NCT03365934|183314494|SUPERIORITY|||||||0.945179|||||||t-test, 2 sided|||||||0.945179
91711373|NCT03365934|183314494|SUPERIORITY|||||||0.972522|||||||t-test, 2 sided|||||||0.972522
91711374|NCT03365934|183314494|SUPERIORITY|||||||0.033704|||||||t-test, 2 sided|||||||0.033704
91711375|NCT03365934|183314494|SUPERIORITY|||||||0.010747|||||||t-test, 2 sided|||||||0.010747
91711376|NCT03365934|183314494|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
91711377|NCT03365934|183314494|SUPERIORITY|||||||0.385474|||||||t-test, 2 sided|||||||0.385474
91711378|NCT03365934|183314494|SUPERIORITY|||||||0.213798|||||||t-test, 2 sided|||||||0.213798
91711379|NCT03365934|183314494|SUPERIORITY|||||||0.388682|||||||t-test, 2 sided|||||||0.388682
91711380|NCT03365934|183314494|SUPERIORITY|||||||0.22386|||||||t-test, 2 sided|||||||0.22386
91711381|NCT03365934|183314494|SUPERIORITY|||||||0.999494|||||||t-test, 2 sided|||||||0.999494
91711382|NCT03365934|183314495|SUPERIORITY|||||||0.891244|||||||t-test, 2 sided|||||||0.891244
91711383|NCT03365934|183314495|SUPERIORITY|||||||0.022659|||||||t-test, 2 sided|||||||0.022659
91711384|NCT03365934|183314495|SUPERIORITY|||||||0.693615|||||||t-test, 2 sided|||||||0.693615
91711385|NCT03365934|183314495|SUPERIORITY|||||||0.000237|||||||t-test, 2 sided|||||||0.000237
91711386|NCT03365934|183314495|SUPERIORITY|||||||5e-06|||||||t-test, 2 sided|||||||0.000005
91711387|NCT03365934|183314495|SUPERIORITY|||||||0.352008|||||||t-test, 2 sided|||||||0.352008
91711388|NCT03365934|183314495|SUPERIORITY|||||||0.998761|||||||t-test, 2 sided|||||||0.998761
91711389|NCT03365934|183314495|SUPERIORITY|||||||0.017832|||||||t-test, 2 sided|||||||0.017832
91711390|NCT03365934|183314495|SUPERIORITY|||||||0.000974|||||||t-test, 2 sided|||||||0.000974
91711391|NCT03365934|183314495|SUPERIORITY|||||||0.638238|||||||t-test, 2 sided|||||||0.638238
91711392|NCT03365934|183314495|SUPERIORITY|||||||0.777423|||||||t-test, 2 sided|||||||0.777423
91711393|NCT03365934|183314495|SUPERIORITY|||||||0.249909|||||||t-test, 2 sided|||||||0.249909
91711394|NCT03365934|183314495|SUPERIORITY|||||||0.068196|||||||t-test, 2 sided|||||||0.068196
91711395|NCT03365934|183314495|SUPERIORITY|||||||0.005786|||||||t-test, 2 sided|||||||0.005786
91711396|NCT03365934|183314495|SUPERIORITY|||||||0.954163|||||||t-test, 2 sided|||||||0.954163
91711397|NCT03365934|183314497|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.851||0.009|TWO_SIDED|95.0|-13.1279|-1.8688|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||-1.8688|-13.1279|0.009
91711398|NCT03365934|183314497|SUPERIORITY||Mean Difference (Net)|-5.08|STANDARD_ERROR_OF_MEAN|2.851||0.077|TWO_SIDED|95.0|-10.7083|0.5508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||0.5508|-10.7083|0.077
91655510|NCT00721409|183203876|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.1347|TWO_SIDED|95.0|0.76|2.97||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||2.97|0.76|0.1347
91655511|NCT00721409|183203876|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.0849|TWO_SIDED|95.0|0.74|7.84||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.84|0.74|0.0849
91655512|NCT00721409|183203876|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.4515|TWO_SIDED|95.0|0.48|2.76||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||2.76|0.48|0.4515
91655513|NCT00721409|183203877|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93||||0.0471|TWO_SIDED|95.0|0.91|4.08||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||4.08|0.91|0.0471
91655514|NCT00721409|183203877|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34||||0.118|TWO_SIDED|95.0|0.65|8.66||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||8.66|0.65|0.1180
91655515|NCT00721409|183203877|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1631|TWO_SIDED|95.0|0.65|4.54||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||4.54|0.65|0.1631
91655516|NCT00721409|183203879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.18||||0.0009|TWO_SIDED|95.0|1.48|6.98||1-sided p-value is from the stratified exact test (1-sided, α =0.10).|Cochran-Mantel-Haenszel|||CBR CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||6.98|1.48|0.0009
91655517|NCT00721409|183203879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||0.0065|TWO_SIDED|95.0|1.3|13.9||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||13.90|1.30|0.0065
91655518|NCT00721409|183203879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.0442|TWO_SIDED|95.0|0.89|7.7||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.70|0.89|0.0442
91655519|NCT00721409|183203880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.399|||<|0.0001|TWO_SIDED|95.0|0.265|0.601||1-sided p-value is from the stratified log-rank test (α =0.10).|Log Rank|||Kaplan-Meier method was applied for median and 95% CI. Hazard ratio was based on assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib + letrozole.||0.601|0.265|<0.0001
91655520|NCT00721409|183203880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.572|0.156|<0.0001
91655521|NCT00721409|183203880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486||||0.003|TWO_SIDED|95.0|0.288|0.822||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.822|0.288|0.0030
91655522|NCT00721409|183203881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.7|1.0||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.0|-0.7|0.6900
91655523|NCT00721409|183203881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.7125|TWO_SIDED|95.0|-1.8|1.2||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.2|-1.8|0.7125
91655524|NCT00721409|183203881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4012|TWO_SIDED|95.0|-0.6|1.5||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.5|-0.6|0.4012
91655525|NCT00721409|183203882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3346|TWO_SIDED|95.0|-0.5|1.3||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.3|-0.5|0.3346
91655526|NCT00721409|183203882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.563|TWO_SIDED|95.0|-1.0|1.9||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.9|-1.0|0.5630
91655527|NCT00721409|183203882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4427|TWO_SIDED|95.0|-0.7|1.6||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.6|-0.7|0.4427
91655528|NCT02483975|183203891|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.92|||||TWO_SIDED|95.0|0.804|1.0505||||||||1.0505|0.8040|
91655529|NCT02483975|183203892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.8096|1.062||||||||1.0620|0.8096|
91655530|NCT02483975|183203893|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||||1.06|0.81|
91655531|NCT02483975|183203894|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.79|||||TWO_SIDED|95.0|0.61|1.03||||||||1.03|0.61|
91655532|NCT02483975|183203895|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||||1.07|0.72|
91691890|NCT02667704|183278333|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|103.36|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|86.134|124.025|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||124.025|86.134|
91711399|NCT03365934|183314497|SUPERIORITY||Mean Difference (Net)|-2.41|STANDARD_ERROR_OF_MEAN|2.851||0.399|TWO_SIDED|95.0|-8.0399|3.2192|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||3.2192|-8.0399|0.399
91614285|NCT01355068|183122659|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.33|||||TWO_SIDED|90.0|97.85|104.94||||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||104.94|97.85|
91614286|NCT01355068|183122660|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|102.2|||||TWO_SIDED|90.0|97.18|107.47||||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.47|97.18|
91655533|NCT00818883|183203896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.3|-2.9||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.9|-8.3|<0.001
91655534|NCT00818883|183203896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|||<|0.001||95.0|-7.5|-2.5||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.5|-7.5|<0.001
91614287|NCT01355068|183122661|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.43|||||TWO_SIDED|90.0|97.56|105.47||||||Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.47|97.56|
91614288|NCT00336492|183122671|SUPERIORITY_OR_OTHER|||||||0.146|||||||Chi-squared|||||||0.146
91614289|NCT00227877|183122680|SUPERIORITY||Adjusted Relative Risk Ratio|1.39|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|1.08|1.8|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.80|1.08|< 0.05
91655535|NCT00818883|183203897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||<|0.001|TWO_SIDED|95.0|-5.2|-2.2||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.2|-5.2|<0.001
91655536|NCT00818883|183203897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-4.1|-1.3||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.3|-4.1|<0.001
91655537|NCT00818883|183203898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.001|TWO_SIDED|95.0|-10.5|-4.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-4.2|-10.5|<0.001
91655538|NCT00818883|183203898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.001|TWO_SIDED|95.0|-6.8|-1.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.7|-6.8|0.001
91655539|NCT00818883|183203899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||<|0.001|TWO_SIDED|95.0|-6.3|-2.3||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.3|-6.3|<0.001
91655540|NCT00818883|183203899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.006|TWO_SIDED|95.0|-4.2|-0.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-0.7|-4.2|0.006
91655541|NCT00818883|183203900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|-8.4|-3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-3.2|-8.4|<0.001
91655542|NCT00818883|183203900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.4|-2.0||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.0|-6.4|<0.001
91655543|NCT00818883|183203901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-5.5|-2.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.1|-5.5|<0.001
91655544|NCT00818883|183203901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-4.1|-1.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.1|-4.1|<0.001
91655545|NCT03879239|183203921|SUPERIORITY|||||||0.0011||||||Responder Rate on Weekly CSBM1 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0011
91655546|NCT03879239|183203921|SUPERIORITY|||||||0.0085||||||Responder Rate on Weekly CSBM2 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0085
91614290|NCT00227877|183122681|SUPERIORITY||Adjusted Relative Risk Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.32|TWO_SIDED|95.0|0.34|1.42|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.42|0.34|.32
91711400|NCT03365934|183314497|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|2.851||0.802|TWO_SIDED|95.0|-4.9144|6.3446|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||6.3446|-4.9144|0.802
91711401|NCT03365934|183314498|SUPERIORITY||Mean Difference (Net)|-11.37|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-17.3738|-5.3723|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||-5.3723|-17.3738|<0.001
91711402|NCT03365934|183314498|SUPERIORITY||Mean Difference (Net)|-12.68|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-18.6789|-6.6775|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-6.6775|-18.6789|<0.001
91711403|NCT03365934|183314498|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|3.038||0.521|TWO_SIDED|95.0|-7.9571|4.0444|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||4.0444|-7.9571|0.521
91711404|NCT03365934|183314498|SUPERIORITY||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|3.038||0.006|TWO_SIDED|95.0|2.3925|14.394|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||14.3940|2.3925|0.006
91711405|NCT03365934|183314499|SUPERIORITY||Mean Difference (Net)|-31.83|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-41.3967|-22.2538|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||-22.2538|-41.3967|<0.001
91711406|NCT03365934|183314499|SUPERIORITY||Mean Difference (Net)|-27.3|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-36.8727|-17.7298|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-17.7298|-36.8727|<0.001
91711407|NCT03365934|183314499|SUPERIORITY||Mean Difference (Net)|-13.71|STANDARD_ERROR_OF_MEAN|4.847||0.005|TWO_SIDED|95.0|-23.2784|-4.1355|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||-4.1355|-23.2784|0.005
91711408|NCT03365934|183314499|SUPERIORITY||Mean Difference (Net)|10.07|STANDARD_ERROR_OF_MEAN|4.847||0.039|TWO_SIDED|95.0|0.4969|19.6398|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||19.6398|0.4969|0.039
91655547|NCT03179345|183203948|SUPERIORITY||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.06||0.0275|TWO_SIDED|95.0|-0.266|-0.016|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.016|-0.266|0.0275
91711409|NCT03365934|183314500|SUPERIORITY||Mean Difference (Net)|-40.39|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-51.0324|-29.7496|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-29.7496|-51.0324|<0.001
91711410|NCT03365934|183314500|SUPERIORITY||Mean Difference (Net)|-37.84|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-48.4787|-27.1959|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-27.1959|-48.4787|<0.001
91711411|NCT03365934|183314500|SUPERIORITY||Mean Difference (Net)|-20.99|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-31.6336|-10.3508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||-10.3508|-31.6336|<0.001
91711412|NCT03365934|183314500|SUPERIORITY||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.39||0.106|TWO_SIDED|95.0|-1.8871|19.3957|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||19.3957|-1.8871|0.106
91711413|NCT03365934|183314501|SUPERIORITY||Mean Difference (Net)|-32.9|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-43.3249|-22.4838|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-22.4838|-43.3249|<0.001
91711414|NCT03365934|183314501|SUPERIORITY||Mean Difference (Net)|-27.31|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-37.7279|-16.8868|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-16.8868|-37.7279|<0.001
91655548|NCT03179345|183203948|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
91655549|NCT03179345|183203949|SUPERIORITY||Mean Difference (Net)|-0.102|STANDARD_ERROR_OF_MEAN|0.06||0.1103|TWO_SIDED|95.0|-0.227|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.024|-0.227|0.1103
91711415|NCT03365934|183314501|SUPERIORITY||Mean Difference (Net)|-18.76|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-29.1785|-8.3374|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-8.3374|-29.1785|<0.001
91711416|NCT03365934|183314501|SUPERIORITY||Mean Difference (Net)|6.79|STANDARD_ERROR_OF_MEAN|5.276||0.2|TWO_SIDED|95.0|-3.6303|17.2107|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||17.2107|-3.6303|0.200
91711417|NCT03365934|183314502|SUPERIORITY||Mean Difference (Net)|-30.9|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-39.5325|-22.265|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-22.2650|-39.5325|<0.001
91711418|NCT03365934|183314502|SUPERIORITY||Mean Difference (Net)|-25.33|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-33.9669|-16.6993|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-16.6993|-33.9669|<0.001
91711419|NCT03365934|183314502|SUPERIORITY||Mean Difference (Net)|-20.63|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-29.2588|-11.9912|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-11.9912|-29.2588|<0.001
91711420|NCT03365934|183314502|SUPERIORITY||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|4.371||0.33|TWO_SIDED|95.0|-4.362|12.9055|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||12.9055|-4.3620|0.330
91711421|NCT03365934|183314503|SUPERIORITY||Mean Difference (Net)|-13.95|STANDARD_ERROR_OF_MEAN|3.754|<|0.001|TWO_SIDED|95.0|-21.368|-6.5419|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-6.5419|-21.3680|<0.001
91711422|NCT03365934|183314503|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_ERROR_OF_MEAN|3.754||0.002|TWO_SIDED|95.0|-18.9563|-4.1302|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-4.1302|-18.9563|0.002
91711423|NCT03365934|183314503|SUPERIORITY||Mean Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|3.754||0.008|TWO_SIDED|95.0|-17.4867|-2.6606|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-2.6606|-17.4867|0.008
91711424|NCT03365934|183314503|SUPERIORITY||Mean Difference (Net)|6.87|STANDARD_ERROR_OF_MEAN|3.754||0.069|TWO_SIDED|95.0|-0.5447|14.2814|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||14.2814|-0.5447|0.069
91711425|NCT03365934|183314504|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|3.244||0.397|TWO_SIDED|95.0|-9.1631|3.6504|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||3.6504|-9.1631|0.397
91711426|NCT03365934|183314504|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|3.244||0.804|TWO_SIDED|95.0|-5.6006|7.2129|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||7.2129|-5.6006|0.804
91711427|NCT03365934|183314504|SUPERIORITY||Mean Difference (Net)|-9.32|STANDARD_ERROR_OF_MEAN|3.244||0.005|TWO_SIDED|95.0|-15.7231|-2.9096|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-2.9096|-15.7231|0.005
91711428|NCT03365934|183314504|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|3.244||0.985|TWO_SIDED|95.0|-6.3452|6.4683|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||6.4683|-6.3452|0.985
91711429|NCT03365934|183314506|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.348|TWO_SIDED|95.0|-0.129|0.0458|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||0.0458|-0.1290|0.348
91711430|NCT03365934|183314506|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.044||0.019|TWO_SIDED|95.0|-0.1904|-0.0178|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||-0.0178|-0.1904|0.019
91711431|NCT03365934|183314506|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.183|TWO_SIDED|95.0|-0.1437|0.0278|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||0.0278|-0.1437|0.183
91711432|NCT03365934|183314506|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.044||0.736|TWO_SIDED|95.0|-0.0725|0.1023|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||0.1023|-0.0725|0.736
91711433|NCT03365934|183314507|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.052||0.516|TWO_SIDED|95.0|-0.136|0.0687|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||0.0687|-0.1360|0.516
91711434|NCT03365934|183314507|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.052||0.006|TWO_SIDED|95.0|-0.2459|-0.0412|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-0.0412|-0.2459|0.006
91614291|NCT00227877|183122682|SUPERIORITY||Adjusted Relative Risk Ratio|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.05|TWO_SIDED|95.0|0.99|3.27|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|||Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|3.27|.99|0.05
91614292|NCT00227877|183122683|SUPERIORITY||Adjusted Relative Risk Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|0.53|1.16|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.16|.53|0.23
91614293|NCT00227877|183122684|SUPERIORITY||Adjusted Relative Risk Ratio|1.52|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|95.0|0.97|2.36|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.36|.97|.07
91614294|NCT00227877|183122685|SUPERIORITY||Adjusted Relative Risk Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.41||0.93|TWO_SIDED|95.0|0.42|2.21|||Regression, Logistic||Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||2.21|.42|.93
91614295|NCT00227877|183122686|SUPERIORITY||Adjusted Relative Risk Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.5||0.78|TWO_SIDED|95.0|0.27|2.7|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.70|.27|.78
91711435|NCT03365934|183314507|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.671|TWO_SIDED|95.0|-0.1235|0.0798|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||0.0798|-0.1235|0.671
91711436|NCT03365934|183314507|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.052||0.004|TWO_SIDED|95.0|0.0504|0.2578|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||0.2578|0.0504|0.004
91711437|NCT03365934|183314508|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.062||0.292|TWO_SIDED|95.0|-0.1896|0.0579|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||0.0579|-0.1896|0.292
91711438|NCT03365934|183314508|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.016|TWO_SIDED|95.0|-0.2773|-0.0297|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-0.0297|-0.2773|0.016
91711439|NCT03365934|183314508|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.062||0.538|TWO_SIDED|95.0|-0.1622|0.0853|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||0.0853|-0.1622|0.538
91711440|NCT03365934|183314508|SUPERIORITY||Mean Difference (Net)|0.012|STANDARD_ERROR_OF_MEAN|0.065||0.061|TWO_SIDED|95.0|-0.0059|0.2515|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||0.2515|-0.0059|0.061
91711441|NCT03365934|183314509|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.3265|-0.0895|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-0.0895|-0.3265|0.001
91711442|NCT03365934|183314509|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3614|-0.1243|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-0.1243|-0.3614|<0.001
91711443|NCT03365934|183314509|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.1899|0.0471|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||0.0471|-0.1899|0.236
91711444|NCT03365934|183314509|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.061||0.627|TWO_SIDED|95.0|-0.0902|0.1492|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||0.1492|-0.0902|0.627
91711445|NCT03365934|183314510|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED|95.0|-0.3331|-0.1305|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-0.1305|-0.3331|<0.001
91711446|NCT03365934|183314510|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3091|-0.1092|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-0.1092|-0.3091|<0.001
91711447|NCT03365934|183314510|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.005|TWO_SIDED|95.0|-0.2439|-0.0457|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-0.0457|-0.2439|0.005
91711448|NCT03365934|183314510|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.052||0.02|TWO_SIDED|95.0|0.0197|0.2252|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||0.2252|0.0197|0.020
91711449|NCT03365934|183314511|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4019|-0.2044|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-0.2044|-0.4019|<0.001
91711450|NCT03365934|183314511|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3655|-0.1679|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-0.1679|-0.3655|<0.001
91711451|NCT03365934|183314511|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3338|-0.1377|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-0.1377|-0.3338|<0.001
91711452|NCT03365934|183314511|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.646|TWO_SIDED|95.0|-0.0767|0.1231|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||0.1231|-0.0767|0.646
91711453|NCT03365934|183314512|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.047||0.006|TWO_SIDED|95.0|-0.2254|-0.0384|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-0.0384|-0.2254|0.006
91711454|NCT03365934|183314512|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.002|TWO_SIDED|95.0|-0.2444|-0.0574|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-0.0574|-0.2444|0.002
91711455|NCT03365934|183314512|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.001|TWO_SIDED|95.0|-0.2541|-0.0682|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-0.0682|-0.2541|0.001
91711456|NCT03365934|183314512|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.911|TWO_SIDED|95.0|-0.0891|0.0998|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||0.0998|-0.0891|0.911
91711457|NCT03365934|183314513|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.937|TWO_SIDED|95.0|-0.0818|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||0.0755|-0.0818|0.937
91527409|NCT01003184|182930046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.06|||<|0.0001|TWO_SIDED|95.0|3.64|13.7|||Regression, Logistic|Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.||||13.70|3.64|<.0001
91614296|NCT00227877|183122687|SUPERIORITY||Adjusted Relative Risk Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|0.51|1.09|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||1.09|.51|.13
91614297|NCT00227877|183122688|SUPERIORITY||Adjusted Relative Risk Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.11||0.66|TWO_SIDED|95.0|0.48|0.91|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||.91|.48|.66
91524203|NCT04843930|182923541|SUPERIORITY||Mean Difference (Final Values)|4.37||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 73.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
91614298|NCT00227877|183122689|SUPERIORITY||Adjusted Relative Risk Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.35|TWO_SIDED|95.0|0.64|1.17||Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||1.17|.64|.35
91614299|NCT00227877|183122690|SUPERIORITY||Adjusted Relative Risk Ratio|0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.01|TWO_SIDED|95.0|0.46|0.87|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.87|.46|<.01
91711458|NCT03365934|183314513|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.026|TWO_SIDED|95.0|-0.1663|-0.0108|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||-0.0108|-0.1663|0.026
91711459|NCT03365934|183314513|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.045|TWO_SIDED|95.0|-0.1562|-0.0017|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-0.0017|-0.1562|0.045
91711460|NCT03365934|183314513|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.039||0.956|TWO_SIDED|95.0|-0.0799|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||0.0755|-0.0799|0.956
91711461|NCT02964338|183314522|OTHER||Least square (LS) mean difference|3.5||||0.2741|TWO_SIDED|95.0|-2.8|9.82||Threshold for significance at 0.05 level.|ANCOVA|||||9.82|-2.80|0.2741
91711462|NCT02964338|183314522|OTHER||LS mean difference|-3.3||||0.3047|TWO_SIDED|95.0|-9.59|3.01||Threshold for significance at 0.05 level.|ANCOVA|||||3.01|-9.59|0.3047
91711463|NCT04611542|183314536|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91711464|NCT04611542|183314537|SUPERIORITY||Median Difference (Final Values)|1.12|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91711465|NCT04611542|183314538|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||<0.001
91711466|NCT02291029|183314539|SUPERIORITY||Mean Difference (Net)|-0.41||||0.397|TWO_SIDED|95.0|-3.7|2.89||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.89|-3.70|0.397
91711467|NCT02291029|183314539|SUPERIORITY||Mean Difference (Net)|-5.21||||0.009|TWO_SIDED|95.0|-9.46|-0.96||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||-0.96|-9.46|0.009
91711468|NCT02291029|183314539|SUPERIORITY||Mean Difference (Net)|2.34||||0.344|TWO_SIDED|95.0|-2.78|7.45||two-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||7.45|-2.78|0.344
91791316|NCT00492063|183460306|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||8|-2|
91524204|NCT02552238|182923542|SUPERIORITY|||||||0.0067|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0067
91524205|NCT02552238|182923542|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
91614300|NCT00227877|183122691|SUPERIORITY||Adjusted Relative Risk Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.54|0.98|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.98|.54|< 0.05
91614301|NCT03141307|183122692|EQUIVALENCE|95% margin|||||<|0.001||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.001
91614302|NCT03141307|183122693|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
91614303|NCT03141307|183122694|EQUIVALENCE|95% margin|||||=|0.502||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.502
91614304|NCT03141307|183122695|EQUIVALENCE|95% margin|||||=|0.071||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.071
91614305|NCT03141307|183122696|EQUIVALENCE|95% margin|||||=|0.124||||||a prior threshold for statistical significance set for p \< .05.|t-test, 2 sided|||||||=.124
91614306|NCT03141307|183122697|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
91614307|NCT02522481|183122717|SUPERIORITY|||||||0.0896|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0896
91614308|NCT02522481|183122717|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
91614309|NCT00410280|183122722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.0947|TWO_SIDED|95.0|-14.04|1.15|||ANOVA|||Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.||1.15|-14.04|0.0947
91614310|NCT00410280|183122723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24||||0.2673|TWO_SIDED|95.0|-11.84|3.35|||ANOVA|||Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.35|-11.84|0.2673
91614311|NCT00410280|183122724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8||||0.0391|TWO_SIDED|95.0|-46.35|-1.24|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.24|-46.35|0.0391
91791317|NCT00492063|183460306|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|6.0|||||TWO_SIDED|95.0|2.0|11.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||11|2|
91791318|NCT00492063|183460307|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.07|||||TWO_SIDED|95.0|0.9|1.28||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||1.28|0.9|
91791319|NCT00492063|183460307|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||0.99|0.72|
91791320|NCT00492063|183460307|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.14|||||TWO_SIDED|95.0|0.99|1.3||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||1.3|0.99|
91791321|NCT00492063|183460307|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||1.12|0.82|
91711469|NCT02291029|183314540|SUPERIORITY||Mean Difference (Net)|-1.09||||0.205|TWO_SIDED|95.0|-2.97|0.8|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.80|-2.97|0.205
91711470|NCT02291029|183314540|SUPERIORITY||Mean Difference (Net)|-0.95||||0.188|TWO_SIDED|95.0|-2.41|0.5|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.50|-2.41|0.188
91711471|NCT02291029|183314540|SUPERIORITY||Mean Difference (Net)|-0.37||||0.663|TWO_SIDED|95.0|-2.08|1.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.35|-2.08|0.663
91791322|NCT00492063|183460307|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||1.02|0.74|
91614312|NCT00410280|183122724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.17||||0.1326|TWO_SIDED|95.0|-39.72|5.39|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.39|-39.72|0.1326
91614313|NCT00410280|183122725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76||||0.0423|TWO_SIDED|95.0|-19.16|-0.35|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-0.35|-19.16|0.0423
91711472|NCT02291029|183314541|SUPERIORITY||Mean Difference (Net)|-15.26||||0.161|TWO_SIDED|95.0|-37.9|7.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||7.38|-37.90|0.161
91711473|NCT02291029|183314541|SUPERIORITY||Mean Difference (Net)|-12.16||||0.017|TWO_SIDED|95.0|-21.94|-2.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||-2.38|-21.94|0.017
91711474|NCT02291029|183314542|SUPERIORITY||Mean Difference (Net)|-9.45||||0.456|TWO_SIDED|95.0|-36.2|17.3|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||17.30|-36.20|0.456
91711475|NCT02291029|183314542|SUPERIORITY||Mean Difference (Net)|-8.14||||0.376|TWO_SIDED|95.0|-26.67|10.39|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||10.39|-26.67|0.376
91711476|NCT02291029|183314543|SUPERIORITY||Mean Difference (Net)|-5.5||||0.172|TWO_SIDED|95.0|-13.91|2.91|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.91|-13.91|0.172
91711477|NCT02291029|183314543|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
91791323|NCT00492063|183460307|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.27|||||TWO_SIDED|95.0|1.11|1.4||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||1.4|1.11|
91614314|NCT00410280|183122725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06||||0.3902|TWO_SIDED|95.0|-13.46|5.35|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.35|-13.46|0.3902
91614315|NCT00410280|183122726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05||||0.0302|TWO_SIDED|95.0|-36.21|-1.9|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.90|-36.21|0.0302
91614316|NCT00410280|183122726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.1289|TWO_SIDED|95.0|-30.34|3.97|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.97|-30.34|0.1289
91655550|NCT03179345|183203949|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
91655551|NCT03179345|183203950|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9946|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9946
91655552|NCT03179345|183203950|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.0125||0.1673|TWO_SIDED|95.0|-0.01|0.04|||ANCOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.04|-0.01|0.1673
91711478|NCT02291029|183314544|SUPERIORITY||Mean Difference (Net)|-0.07||||0.986|TWO_SIDED|95.0|-8.49|8.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||8.35|-8.49|0.986
91711479|NCT02291029|183314544|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
91711480|NCT02291029|183314545|SUPERIORITY||Mean Difference (Net)|1.34||||0.807|TWO_SIDED|95.0|-10.48|13.15|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||13.15|-10.48|0.807
91711481|NCT02291029|183314545|SUPERIORITY||Mean Difference (Net)|-9.83||||0.074|TWO_SIDED|95.0|-20.66|1.01|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.01|-20.66|0.074
91711482|NCT02171429|183314546|SUPERIORITY||Difference in Remission Rates|7.2||||0.1729|TWO_SIDED|95.0|-3.83|16.12||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||16.12|-3.83|0.1729
91711483|NCT02171429|183314547|SUPERIORITY||Difference in Remission Rates|-6.8||||0.1458|TWO_SIDED|95.0|-16.26|2.73||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.73|-16.26|0.1458
91524206|NCT01576718|182923546|SUPERIORITY_OR_OTHER|||||||0.0604||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.0604
91655553|NCT03179345|183203950|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0125||0.6208|TWO_SIDED|95.0|-0.02|0.03|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.03|-0.02|0.6208
91655554|NCT03179345|183203951|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|2.6||0.8799|TWO_SIDED|95.0|-5.59|4.8|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||4.80|-5.59|0.8799
91655555|NCT03179345|183203951|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|2.61||0.9277|TWO_SIDED|95.0|-4.97|5.45|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||5.45|-4.97|0.9277
91655556|NCT03179345|183203951|SUPERIORITY||Mean Difference (Net)|-3.73||||0.1587|TWO_SIDED|95.0|-8.94|1.49|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.49|-8.94|0.1587
91655557|NCT03179345|183203952|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0125||0.7111|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.03|0.7111
91711484|NCT02171429|183314548|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
91655558|NCT03179345|183203952|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9048|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9048
91711485|NCT02171429|183314549|SUPERIORITY||Difference in Response Rates|14.0||||0.1729|TWO_SIDED|95.0|-0.12|27.19||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||27.19|-0.12|0.1729
91791324|NCT01947855|183460315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.87|STANDARD_ERROR_OF_MEAN|19.88|<|0.0001|TWO_SIDED|95.0|-144.77|-64.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-64.97|-144.77|<0.0001
91711486|NCT02171429|183314549|SUPERIORITY||Difference in Response Rates|-2.5||||0.6726|TWO_SIDED|95.0|-13.83|9.01||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.01|-13.83|0.6726
91711487|NCT02171429|183314550|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
91711488|NCT02171429|183314551|SUPERIORITY||Difference in Response Rates|9.4||||0.2372|TWO_SIDED|95.0|-4.31|21.95||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||21.95|-4.31|0.2372
91711489|NCT02171429|183314551|SUPERIORITY||Difference in Response Rates|-3.5||||0.5341|TWO_SIDED|95.0|-14.76|7.82||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.82|-14.76|0.5341
91711490|NCT02171429|183314552|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
91711491|NCT02171429|183314553|SUPERIORITY||Difference in Remission Rates|11.2||||0.2372|TWO_SIDED|95.0|0.59|19.76||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||19.76|0.59|0.2372
91524207|NCT01576718|182923546|SUPERIORITY_OR_OTHER||LSM difference|0.072||||0.0637|TWO_SIDED|95.0|-0.004|0.149||Significance at the 0.05 level.|mixed model for repeated measures||Fp 400 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.149|-0.004|0.0637
91614317|NCT00410280|183122727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8469|TWO_SIDED|95.0|-0.79|0.96|||Mixed Models Analysis|||Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.96|-0.79|0.8469
91614318|NCT00410280|183122727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-0.86|0.86|||Mixed Models Analysis|||Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.86|-0.86|0.9995
91614319|NCT00410280|183122727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.528|TWO_SIDED|95.0|-1.14|0.59|||Mixed Models Analysis|||Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.59|-1.14|0.5280
91655559|NCT03179345|183203952|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3262|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.01|-0.03|0.3262
91655560|NCT03179345|183203953|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.595|TWO_SIDED|95.0|-2.18|1.26|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.26|-2.18|0.5950
91614320|NCT01109004|183122749|SUPERIORITY|||||||0.87||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.87
91524208|NCT01576718|182923546|SUPERIORITY_OR_OTHER||LSM difference|0.056||||0.1585|TWO_SIDED|95.0|-0.022|0.133||Significance at the 0.05 level|mixed model for repeated measures||Fp 200 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.133|-0.022|0.1585
91614321|NCT01109004|183122749|SUPERIORITY|||||||0.37||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.37
91655561|NCT03179345|183203953|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.865||0.7057|TWO_SIDED|95.0|-1.4|2.06|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.06|-1.40|0.7057
91655562|NCT03179345|183203953|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.865||0.6741|TWO_SIDED|95.0|-1.36|2.1|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.10|-1.36|0.6741
91524209|NCT01576718|182923546|SUPERIORITY_OR_OTHER||LSM difference|0.048||||0.2221|TWO_SIDED|95.0|-0.029|0.124||Significance at the 0.05 level|mixed model for repeated measures||Fp 100 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.124|-0.029|0.2221
91655563|NCT03179345|183203954|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.0175||0.007|TWO_SIDED|95.0|-0.08|-0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.01|-0.08|0.0070
91655564|NCT03179345|183203954|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5183|TWO_SIDED|95.0|-0.02|0.05|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.05|-0.02|0.5183
91614322|NCT01109004|183122749|SUPERIORITY|||||||0.27||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.27
91655565|NCT03179345|183203954|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5084|TWO_SIDED|95.0|-0.05|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.05|0.5084
91524210|NCT01576718|182923546|SUPERIORITY_OR_OTHER||LSM difference|0.006|||=|0.8694|TWO_SIDED|95.0|-0.07|0.083||Significance at the 0.05 level|mixed model for repeated measures||Fp 50 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.083|-0.070|=0.8694
91655566|NCT03179345|183203955|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.307||0.1026|TWO_SIDED|95.0|-0.104|1.124|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.124|-0.104|0.1026
91655567|NCT03179345|183203955|SUPERIORITY||Mean Difference (Net)|-0.094|STANDARD_ERROR_OF_MEAN|0.309||0.7634|TWO_SIDED|95.0|-0.711|0.523|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.523|-0.711|0.7634
91655568|NCT03179345|183203955|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.309||0.1041|TWO_SIDED|95.0|-0.107|1.127|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.127|-0.107|0.1041
91655569|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.286|STANDARD_ERROR_OF_MEAN|0.12||0.0177|TWO_SIDED|95.0|-0.521|-0.051|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||-0.051|-0.521|0.0177
91614323|NCT01109004|183122750|SUPERIORITY|||||||0.92||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.92
91614324|NCT01109004|183122750|SUPERIORITY|||||||0.21||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.21
91614325|NCT01109004|183122750|SUPERIORITY|||||||0.22||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.22
91614326|NCT01109004|183122751|SUPERIORITY|||||||0.26||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.26
91614327|NCT01109004|183122751|SUPERIORITY|||||||0.53||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.53
91614328|NCT01109004|183122751|SUPERIORITY|||||||0.57||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.57
91614329|NCT01109004|183122752|SUPERIORITY|||||||0.63||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.63
91614330|NCT01109004|183122752|SUPERIORITY|||||||0.15||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.15
91614331|NCT01109004|183122752|SUPERIORITY|||||||0.33||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.33
91614332|NCT00747617|183122766|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
91614333|NCT00137436|183122786|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.942
91614334|NCT00137436|183122786|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.323
91614335|NCT00137436|183122786|SUPERIORITY_OR_OTHER|||||||0.865||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.865
91614336|NCT00137436|183122786|SUPERIORITY_OR_OTHER|||||||0.873||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.873
91614337|NCT00137436|183122787|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.736
91614338|NCT00137436|183122787|SUPERIORITY_OR_OTHER|||||||0.962||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.962
91614339|NCT00137436|183122787|SUPERIORITY_OR_OTHER|||||||0.185||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.185
91614340|NCT00137436|183122787|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||1.000
91614341|NCT00137436|183122788|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.386
91614342|NCT00137436|183122788|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.904
91614343|NCT00137436|183122788|SUPERIORITY_OR_OTHER|||||||0.812||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.812
91614344|NCT00137436|183122788|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.490
91614345|NCT00137436|183122789|SUPERIORITY_OR_OTHER|||||||0.839||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.839
91614346|NCT00137436|183122789|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.219
91614347|NCT00137436|183122789|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.788
91614348|NCT00137436|183122789|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.164
91614349|NCT00137436|183122790|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.656
91614350|NCT00137436|183122790|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.628
91614351|NCT00137436|183122790|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.420
91614352|NCT00137436|183122790|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
91614353|NCT00137436|183122791|SUPERIORITY_OR_OTHER|||||||0.903||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.903
91614354|NCT00137436|183122791|SUPERIORITY_OR_OTHER|||||||0.434||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.434
91614355|NCT00137436|183122791|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.687
91614356|NCT00137436|183122791|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
91614357|NCT04657016|183122796|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-26.1|-22.8|||Mixed Models Analysis|||||-22.8|-26.1|<0.001
91614358|NCT04657016|183122797|SUPERIORITY||Odds Ratio (OR)|130.36|||<|0.001|TWO_SIDED|95.0|69.98|242.84|||Regression, Logistic|||||242.84|69.98|<0.001
91614359|NCT04657016|183122798|SUPERIORITY||Odds Ratio (OR)|101.6|||<|0.001|TWO_SIDED|95.0|39.17|263.55|||Regression, Logistic|||||263.55|39.17|<0.001
91614360|NCT04657016|183122799|SUPERIORITY||Odds Ratio (OR)|153.95|||<|0.001|TWO_SIDED|95.0|78.9|300.37|||Regression, Logistic|||||300.37|78.90|<0.001
91614361|NCT04657016|183122800|SUPERIORITY||Odds Ratio (OR)|144.48|||<|0.001|TWO_SIDED|95.0|62.65|333.21|||Regression, Logistic|||||333.21|62.65|<0.001
91711492|NCT02171429|183314553|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1192|TWO_SIDED|95.0|-17.2|2.33||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.33|-17.20|0.1192
91614362|NCT04657016|183122801|SUPERIORITY||Odds Ratio (OR)|118.06|||<|0.001|TWO_SIDED|95.0|40.08|347.74|||Regression, Logistic|||||347.74|40.08|<0.001
91614363|NCT04657016|183122802|SUPERIORITY||Mean Difference (Net)|-17.9|||<|0.001|TWO_SIDED|95.0|-19.5|-16.3|||Mixed Models Analysis|||||-16.3|-19.5|<0.001
91614364|NCT04657016|183122803|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.001|TWO_SIDED|95.0|-26.9|-23.2|||Mixed Models Analysis|||||-23.2|-26.9|<0.001
91614365|NCT04657016|183122804|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-9.6|-8.3|||Mixed Models Analysis|||||-8.3|-9.6|<0.001
91614366|NCT04657016|183122805|SUPERIORITY||Mean Difference (Net)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.2|-8.1|||Mixed Models Analysis|||||-8.1|-12.2|<0.001
91614367|NCT04657016|183122806|SUPERIORITY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|95.0|-7.2|-4.3|||Mixed Models Analysis|||||-4.3|-7.2|<0.001
91614368|NCT04657016|183122807|SUPERIORITY||Mean Difference (Net)|-7.79|STANDARD_ERROR_OF_MEAN|1.348|<|0.001|TWO_SIDED|95.0|-10.4|-5.1|||Mixed Models Analysis|||||-5.10|-10.40|<0.001
91614369|NCT04657016|183122808|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|8.2|14.7|||Mixed Models Analysis|||||14.7|8.2|<0.001
91614370|NCT04657016|183122809|SUPERIORITY||Mean Difference (Net)|-11.5|STANDARD_ERROR_OF_MEAN|1.97|<|0.001|TWO_SIDED|95.0|-15.3|-7.53|||Mixed Models Analysis|||||-7.53|-15.30|<0.001
91614371|NCT04657016|183122810|SUPERIORITY||Mean Difference (Net)|-27.8|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-32.1|-23.2|||Mixed Models Analysis|||||-23.2|-32.1|<0.001
91614372|NCT04657016|183122811|SUPERIORITY||Mean Difference (Net)|-28.0|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-32.3|-23.4|||Mixed Models Analysis|||||-23.4|-32.3|<0.001
91614373|NCT04657016|183122812|SUPERIORITY||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-28.4|-13.6|||Mixed Models Analysis|||||-13.6|-28.4|<0.001
91614374|NCT04657016|183122813|SUPERIORITY||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.8|||Mixed Models Analysis|||||-8.8|-13.5|<0.001
91614375|NCT04657016|183122814|SUPERIORITY||Mean Difference (Net)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.53|-0.42|||Mixed Models Analysis|||||-0.42|-0.53|<0.001
91614376|NCT04657016|183122815|SUPERIORITY||Mean Difference (Net)|-48.1|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-53.7|-41.7|||Mixed Models Analysis|||||-41.7|-53.7|<0.001
91614377|NCT04657016|183122816|SUPERIORITY||Mean Difference (Net)|3.8|||<|0.001|TWO_SIDED|95.0|2.8|4.9|||ANCOVA|||||4.9|2.8|<0.001
91614378|NCT04657016|183122817|SUPERIORITY||Mean Difference (Net)|12.8|||<|0.001|TWO_SIDED|95.0|9.7|16.0|||ANCOVA|||||16.0|9.7|<0.001
91614379|NCT00701727|183122818|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||||||0.019
91614380|NCT00701727|183122819|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91614381|NCT00701727|183122820|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91614382|NCT00701727|183122821|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
91614383|NCT00701727|183122822|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91614384|NCT00701727|183122823|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91614385|NCT00701727|183122824|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.95
91614386|NCT00696657|183122873|SUPERIORITY||Estimated treatment differences|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.58|-0.8|||ANOVA|Confidence interval (CIs) for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Placebo. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.80|-1.58|<0.0001
91614387|NCT00696657|183122873|SUPERIORITY||Estimated treatment differences|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.57|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.57|-1.33|<0.0001
91614388|NCT00696657|183122873|SUPERIORITY||Estimated treatment differences|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.59|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.59|-1.35|<0.0001
91614389|NCT00696657|183122873|SUPERIORITY||Estimated treatment differences|-0.61||||0.0002|TWO_SIDED|95.0|-0.98|-0.23|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.4 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.23|-0.98|0.0002
91711493|NCT02171429|183314554|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
91711494|NCT02171429|183314555|SUPERIORITY||Difference in Remission Rates|9.6||||0.2729|TWO_SIDED|95.0|-4.71|22.02||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.02|-4.71|0.2729
91711495|NCT02171429|183314555|SUPERIORITY||Difference in Remission Rates|-14.8||||0.0215|TWO_SIDED|95.0|-26.97|-2.04||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-2.04|-26.97|0.0215
91711496|NCT02171429|183314556|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
91711497|NCT02171429|183314557|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
91711498|NCT02171429|183314557|SUPERIORITY|||||||0.2864||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.2864
91655570|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.157|STANDARD_ERROR_OF_MEAN|0.19||0.412|TWO_SIDED|95.0|-0.536|0.222|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.222|-0.536|0.4120
91655571|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.16||0.7724|TWO_SIDED|95.0|-0.362|0.27|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.270|-0.362|0.7724
91489382|NCT02484690|182851569|SUPERIORITY||Difference in Least Squares Means|-3.09||||0.7382|TWO_SIDED|80.0|-14.95|8.76||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||8.76|-14.95|0.7382
91655572|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.15||0.4255|TWO_SIDED|95.0|-0.423|0.18|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.180|-0.423|0.4255
91711499|NCT02171429|183314558|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
91711500|NCT02171429|183314559|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
91711501|NCT02171429|183314559|SUPERIORITY|||||||0.4174||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.4174
91711502|NCT02171429|183314560|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
91711503|NCT02171429|183314561|SUPERIORITY||Mean Difference (Net)|-1.1||||0.1659|TWO_SIDED|95.0|-2.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-2.8|0.1659
91711504|NCT02171429|183314561|SUPERIORITY||Mean Difference (Net)|0.1||||0.9182|TWO_SIDED|95.0|-1.3|1.4||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||1.4|-1.3|0.9182
91711505|NCT02171429|183314562|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
91711506|NCT02171429|183314562|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
91711507|NCT02171429|183314563|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0116|TWO_SIDED|95.0|-1.7|-0.2||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-0.2|-1.7|0.0116
91711508|NCT02171429|183314563|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6771|TWO_SIDED|95.0|-0.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.8|0.6771
91711509|NCT02171429|183314564|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
91614390|NCT00696657|183122873|SUPERIORITY||Estimated treatment differences|-0.41||||0.0324|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.02|-0.79|0.0324
91614391|NCT00696657|183122873|SUPERIORITY||Estimated treatment differences|-0.09||||0.9772|TWO_SIDED|95.0|-0.46|0.28|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.1 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.28|-0.46|0.9772
91614392|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.35|||||TWO_SIDED|95.0|-0.64|-0.06|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.06|-0.64|
91614393|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.11|||||TWO_SIDED|95.0|-0.39|0.18|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.18|-0.39|
91614394|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.13|||||TWO_SIDED|95.0|-0.42|0.16|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.16|-0.42|
91655573|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.12||0.8925|TWO_SIDED|95.0|-0.229|0.262|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in activities||0.262|-0.229|0.8925
91527410|NCT01003184|182930047|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.104||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-0.20|-0.62|0.0001
91614395|NCT00696657|183122873|OTHER||Estimated treatment differences|0.24|||||TWO_SIDED|95.0|-0.05|0.52|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.52|-0.05|
91614396|NCT00696657|183122873|OTHER||Estimated treatment differences|0.44|||||TWO_SIDED|95.0|0.15|0.73|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.73|0.15|
91614397|NCT00696657|183122873|OTHER||Estimated treatment differences|0.75|||||TWO_SIDED|95.0|0.48|1.03|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||1.03|0.48|
91614398|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.84|||||TWO_SIDED|95.0|-1.12|-0.56|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.8 mg - Placebo . The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.56|-1.12|
91655574|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.212|STANDARD_ERROR_OF_MEAN|0.14||0.1293|TWO_SIDED|95.0|-0.487|0.063|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.063|-0.487|0.1293
91655575|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0304|TWO_SIDED|95.0|-0.266|-0.014|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.014|-0.266|0.0304
91655576|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.084|STANDARD_ERROR_OF_MEAN|0.15||0.5811|TWO_SIDED|95.0|-0.384|0.217|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.217|-0.384|0.5811
91655577|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.098|STANDARD_ERROR_OF_MEAN|0.06||0.1144|TWO_SIDED|95.0|-0.22|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.024|-0.220|0.1144
91655578|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.12||0.3774|TWO_SIDED|95.0|-0.352|0.135|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.135|-0.352|0.3774
91614399|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.51|||||TWO_SIDED|95.0|-0.8|-0.22|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.22|-0.80|
91614400|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.27|||||TWO_SIDED|95.0|-0.56|0.02|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.02|-0.56|
91614401|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.29|||||TWO_SIDED|95.0|-0.58|0.01|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.01|-0.58|
91527411|NCT01003184|182930048|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|0.488|<|0.0001|TWO_SIDED|95.0|-4.63|-2.71|||Mixed Models Analysis|||Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-2.71|-4.63|<.0001
91614402|NCT00696657|183122873|OTHER||Estimated treatment differences|0.08|||||TWO_SIDED|95.0|-0.22|0.37|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.37|-0.22|
91711510|NCT02171429|183314564|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
91711511|NCT02171429|183314565|SUPERIORITY||Difference in Remission Rates|7.9||||0.1382|TWO_SIDED|95.0|-3.19|16.87||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.87|-3.19|0.1382
91711512|NCT02171429|183314565|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1163|TWO_SIDED|95.0|-17.1|2.22||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.22|-17.10|0.1163
91711513|NCT02171429|183314566|SUPERIORITY||Difference in Remission Rates|2.9||||0.4772|TWO_SIDED|95.0|-6.47|10.14||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.14|-6.47|0.4772
91711514|NCT02171429|183314566|SUPERIORITY||Difference in Remission Rates|-5.2||||0.1801|TWO_SIDED|95.0|-12.95|2.63||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.63|-12.95|0.1801
91524211|NCT01576718|182923547|SUPERIORITY_OR_OTHER|||||||0.1512||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.1512
91614403|NCT00696657|183122873|OTHER||Estimated treatment differences|0.28|||||TWO_SIDED|95.0|-0.02|0.57|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.57|-0.02|
91614404|NCT00696657|183122873|OTHER||Estimated treatment differences|0.59|||||TWO_SIDED|95.0|0.31|0.88|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.88|0.31|
91614405|NCT00696657|183122873|OTHER||Estimated treatment differences|-0.68|||||TWO_SIDED|95.0|-0.97|-0.4|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.40|-0.97|
91614406|NCT00738543|183122908|NON_INFERIORITY_OR_EQUIVALENCE|A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.||||<0.05
91614407|NCT00738543|183122910|NON_INFERIORITY_OR_EQUIVALENCE|The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.|||||<|0.05||95.0||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.||||<0.05
91614408|NCT05070429|183123090|SUPERIORITY||Maximum likelihood (MLE)|-0.035||||0.92|TWO_SIDED|95.0|-0.727|0.657||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|generalized linear model (GLM)|generalized linear model (GLM) with an identity link|Confidence intervals and p-values were obtained using a bias-corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare average daily hours of hearing aid use at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the primary outcome.||0.657|-0.727|0.92
91614409|NCT05070429|183123091|SUPERIORITY||Maximum likelihood (MLE)|-0.011||||0.87|TWO_SIDED|95.0|-0.147|0.125|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare treatment satisfaction at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.125|-0.147|0.87
91614410|NCT05070429|183123092|SUPERIORITY||Maximum likelihood (MLE)|0.059||||0.66|TWO_SIDED|95.0|-0.201|0.32|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare primary COSI goal achievement at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.320|-0.201|0.66
91614411|NCT05070429|183123093|SUPERIORITY||Maximum likelihood (MLE)|-1.96||||0.38|TWO_SIDED|95.0|-6.349|2.435|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare hearing-specific quality of life at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||2.435|-6.349|0.38
91614412|NCT03041116|183123095|SUPERIORITY||Difference in LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.8|=|0.9115|TWO_SIDED|95.0|-1.69|1.51||p-value was derived from test of contrast between treatment effects using LSM estimate, adjusted for baseline score and age group from Type III analysis. The test of contrast at Week 24 was considered the primary comparison.|Mixed Models Analysis|||||1.51|-1.69|=0.9115
91614413|NCT03041116|183123097|SUPERIORITY||Difference in LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.1421|TWO_SIDED|95.0|-0.7|4.78||p-value was derived from the test of contrast between treatment effects using the LSM estimate, adjusted for baseline score and age group from the Type III analysis. The test of contrast at week 24 was considered the primary comparison.|Mixed Models Analysis|||||4.78|-0.7|=0.1421
91655579|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.057|STANDARD_ERROR_OF_MEAN|0.34||0.8658|TWO_SIDED|95.0|-0.613|0.727|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.727|-0.613|0.8658
91614414|NCT01345123|183123098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0019994|STANDARD_ERROR_OF_MEAN|0.0400918||0.9602|TWO_SIDED|95.0|-0.0765899|0.080588716|||ANCOVA|Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm||||.080588716|-.07658990|0.9602
91614415|NCT01345123|183123098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013717|STANDARD_ERROR_OF_MEAN|0.04018791||0.7329|TWO_SIDED|95.0|-0.0924947|0.06506063|||ANCOVA|||||0.06506063|-0.0924947|0.7329
91614416|NCT01345123|183123099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.0511||95.0|0.647|1.001|||Regression, Logistic|Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)||||1.001|0.647|0.0511
91614417|NCT01345123|183123102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31257||||0.0106|TWO_SIDED|95.0|0.06895|0.55618|||ANOVA|||||0.55618|0.06895|0.0106
91614418|NCT01345123|183123102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15982||||0.0106|TWO_SIDED|95.0|-0.06477|0.38441|||ANOVA|||||0.38441|-0.06477|0.0106
91614419|NCT01345123|183123105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009122|STANDARD_ERROR_OF_MEAN|0.0467091||0.8454|TWO_SIDED|95.0|-0.1008434|0.08259938|||ANCOVA|||||0.08259938|-0.1008434|0.8454
91655580|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.1||0.8543|TWO_SIDED|95.0|-0.179|0.216|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.216|-0.179|0.8543
91655581|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.153|STANDARD_ERROR_OF_MEAN|0.19||0.4294|TWO_SIDED|95.0|-0.537|0.231|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.231|-0.537|0.4294
91614420|NCT01345123|183123105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0183548|STANDARD_ERROR_OF_MEAN|0.04690321||0.6956|TWO_SIDED|95.0|-0.1102961|0.07358642|||ANCOVA|||||0.07358642|-0.1102961|0.6956
91614421|NCT02436577|183123115|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|93.16|||||TWO_SIDED|90.0|85.8|101.15|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.15|85.80|
91614422|NCT02436577|183123115|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.67|||||TWO_SIDED|90.0|87.88|99.84|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.84|87.88|
91614423|NCT02436577|183123115|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.79|||||TWO_SIDED|90.0|88.27|106.14|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||106.14|88.27|
91614424|NCT02436577|183123115|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.32|||||TWO_SIDED|90.0|85.04|100.23|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||100.23|85.04|
91614425|NCT02436577|183123116|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.76|||||TWO_SIDED|90.0|94.46|101.18|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.18|94.46|
91614426|NCT02436577|183123116|SUPERIORITY_OR_OTHER||Geometric Mean ratio|96.38|||||TWO_SIDED|90.0|93.24|99.63|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.63|93.24|
91614427|NCT02436577|183123116|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.43|||||TWO_SIDED|90.0|94.75|102.25|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.25|94.75|
91614428|NCT02436577|183123116|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.59|98.85|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||98.85|91.59|
91614429|NCT02436577|183123117|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.75|||||TWO_SIDED|90.0|94.4|101.21|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.21|94.40|
91614430|NCT02436577|183123117|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|90.0|93.31|99.8|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.80|93.31|
91614431|NCT02436577|183123117|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.46|||||TWO_SIDED|90.0|94.85|102.2|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.20|94.85|
91614432|NCT02436577|183123117|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.47|||||TWO_SIDED|90.0|91.99|99.08|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||99.08|91.99|
91614433|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-5.4|3.7||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.7|-5.4|
91614434|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-14.2|3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-14.2|
91655582|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.113|STANDARD_ERROR_OF_MEAN|0.12||0.3613|TWO_SIDED|95.0|-0.357|0.132|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.132|-0.357|0.3613
91655583|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.047|STANDARD_ERROR_OF_MEAN|0.13||0.7201|TWO_SIDED|95.0|-0.305|0.212|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.212|-0.305|0.7201
91655584|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.12||0.0767|TWO_SIDED|95.0|-0.448|0.023|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.023|-0.448|0.0767
91614435|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-3.7|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-3.7|
91711515|NCT02171429|183314567|SUPERIORITY||Difference in Adjusted Means|4.0||||0.4833|TWO_SIDED|95.0|-7.2|15.2||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||15.2|-7.2|0.4833
91614436|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.9||||||95.0|-6.9|0.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.7|-6.9|
91614437|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-3.0|3.0||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-3.0|
91614438|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.5||||||95.0|-6.1|0.6||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.6|-6.1|
91614439|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-6.3||||||95.0|-12.1|-0.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.7|-12.1|
91614440|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|3.4||||||95.0|-0.9|7.9||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.9|-0.9|
91655585|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.216|STANDARD_ERROR_OF_MEAN|0.19||0.2618|TWO_SIDED|95.0|-0.597|0.165|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.165|-0.597|0.2618
91791325|NCT01947855|183460315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-85.49|STANDARD_ERROR_OF_MEAN|20.18|<|0.0001|TWO_SIDED|95.0|-126.01|-44.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-44.97|-126.01|<0.0001
91524212|NCT01576718|182923547|SUPERIORITY_OR_OTHER||LSM difference|7.36||||0.2361|TWO_SIDED|95.0|-4.83|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.83|0.2361
91614441|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-4.1|1.1||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-4.1|
91655586|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.16||0.7633|TWO_SIDED|95.0|-0.366|0.269|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.269|-0.366|0.7633
91524213|NCT01576718|182923547|SUPERIORITY_OR_OTHER||LSM difference|7.78||||0.2169|TWO_SIDED|95.0|-4.59|20.15|||Regression, Linear|Significance at the 0.05 level||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.15|-4.59|0.2169
91614442|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.7||||||95.0|-3.0|6.4||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.4|-3.0|
91614443|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-5.8|6.7||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.7|-5.8|
91614444|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-3.2|1.2||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-3.2|
91614445|NCT00366548|183123141|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-3.6|0.3||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.3|-3.6|
91614446|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||1.9|-2.1|
91614447|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.7|2.6||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||2.6|-1.7|
91614448|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
91791326|NCT01816451|183460322|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre-post training variables data were expressed as mean and standard deviation. Heart Rate and Blood Lactate, were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables absolute and relative VO2, tVO2, Body Fat, Body Mass, RPE, were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used.||||< 0.05
91614449|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.9|-2.1|
91655587|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.198|STANDARD_ERROR_OF_MEAN|0.15||0.1968|TWO_SIDED|95.0|-0.502|0.105|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.105|-0.502|0.1968
91524214|NCT01576718|182923547|SUPERIORITY_OR_OTHER||LSM difference|7.09||||0.2523|TWO_SIDED|95.0|-5.07|19.26||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.26|-5.07|0.2523
91614450|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.2|2.3||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.3|-1.2|
91614451|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.0|2.9||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.9|-2.0|
91614452|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.9||||||95.0|-3.4|1.1||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-3.4|
91614453|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.8||||||95.0|-0.8|3.0||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-0.8|
91655588|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.12||0.6891|TWO_SIDED|95.0|-0.296|0.197|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.197|-0.296|0.6891
91655589|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.14||0.2229|TWO_SIDED|95.0|-0.447|0.106|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.106|-0.447|0.2229
91655590|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.072|STANDARD_ERROR_OF_MEAN|0.06||0.2591|TWO_SIDED|95.0|-0.197|0.054|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||0.054|-0.197|0.2591
91655591|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.15||0.7099|TWO_SIDED|95.0|-0.359|0.246|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.246|-0.359|0.7099
91655592|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.06||0.6215|TWO_SIDED|95.0|-0.154|0.092|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.092|-0.154|0.6215
91655593|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.12||0.6422|TWO_SIDED|95.0|-0.302|0.187|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.187|-0.302|0.6422
91655594|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.483|STANDARD_ERROR_OF_MEAN|0.34||0.1574|TWO_SIDED|95.0|-1.157|0.19|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.190|-1.157|0.1574
91655595|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1||0.4039|TWO_SIDED|95.0|-0.115|0.282|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.282|-0.115|0.4039
91655596|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.309|STANDARD_ERROR_OF_MEAN|0.19||0.1145|TWO_SIDED|95.0|-0.695|0.076|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.076|-0.695|0.1145
91655597|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.127|STANDARD_ERROR_OF_MEAN|0.12||0.3083|TWO_SIDED|95.0|-0.372|0.119|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.119|-0.372|0.3083
91655598|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.183|STANDARD_ERROR_OF_MEAN|0.13||0.1638|TWO_SIDED|95.0|-0.443|0.0776|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.0776|-0.443|0.1638
91655599|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.12||0.5101|TWO_SIDED|95.0|-0.314|0.157|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.157|-0.314|0.5101
91655600|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.233|STANDARD_ERROR_OF_MEAN|0.19||0.2285|TWO_SIDED|95.0|-0.614|0.149|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.149|-0.614|0.2285
91655601|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.16||0.4612|TWO_SIDED|95.0|-0.2|0.436|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.436|-0.200|0.4612
91655602|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.205|0.402|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.402|-0.205|0.5190
91655603|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.12||0.8479|TWO_SIDED|95.0|-0.271|0.223|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.223|-0.271|0.8479
91655604|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.14||0.7808|TWO_SIDED|95.0|-0.316|0.238|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.238|-0.316|0.7808
91655605|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.06||0.0083|TWO_SIDED|95.0|-0.296|-0.045|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.045|-0.296|0.0083
91655606|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.101|STANDARD_ERROR_OF_MEAN|0.15||0.5068|TWO_SIDED|95.0|-0.404|0.201|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.201|-0.404|0.5068
91655607|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.068|STANDARD_ERROR_OF_MEAN|0.06||0.2725|TWO_SIDED|95.0|-0.191|0.055|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.055|-0.191|0.2725
91655608|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.12||0.7498|TWO_SIDED|95.0|-0.206|0.284|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.284|-0.206|0.7498
91655609|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.34||0.6554|TWO_SIDED|95.0|-0.522|0.826|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.826|-0.522|0.6554
91655610|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.1||0.4143|TWO_SIDED|95.0|-0.116|0.28|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.280|-0.116|0.4143
91655611|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.055|STANDARD_ERROR_OF_MEAN|0.19||0.7761|TWO_SIDED|95.0|-0.441|0.33|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.330|-0.441|0.7761
91655612|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.12||0.9697|TWO_SIDED|95.0|-0.241|0.251|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.251|-0.241|0.9697
91655613|NCT03179345|183203956|SUPERIORITY||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.13||0.5118|TWO_SIDED|95.0|-0.346|0.174|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.||Motivation|SE of difference estimated by dividing width of 95% CI by 4.|0.174|-0.346|0.5118
91655614|NCT03179345|183203957|SUPERIORITY||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.53||0.8293|TWO_SIDED|95.0|-1.178|0.947|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.947|-1.178|0.8293
91655615|NCT03179345|183203957|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
91655616|NCT03179345|183203958|SUPERIORITY||Mean Difference (Net)|-0.488|STANDARD_ERROR_OF_MEAN|0.53||0.3666|TWO_SIDED|95.0|-1.556|0.581|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.581|-1.556|0.3666
91655617|NCT03179345|183203958|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
91655618|NCT00290745|183203983|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||0.07
91655619|NCT00290745|183203984|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||<0.001
91655620|NCT00290745|183203987|OTHER|||||||0.538|||||||Kruskal-Wallis|||||||0.538
91524215|NCT01576718|182923547|SUPERIORITY_OR_OTHER||LSM difference|8.23||||0.1858|TWO_SIDED|95.0|-3.98|20.45||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.45|-3.98|0.1858
91524216|NCT01576718|182923548|SUPERIORITY_OR_OTHER|||||||0.2879||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.2879
91524217|NCT01576718|182923548|SUPERIORITY_OR_OTHER||LSM difference|7.56||||0.2166|TWO_SIDED|95.0|-4.45|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.45|0.2166
91524218|NCT01576718|182923548|SUPERIORITY_OR_OTHER||LSM difference|4.03||||0.5167|TWO_SIDED|95.0|-8.17|16.23||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||16.23|-8.17|0.5167
91614454|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.6||||||95.0|-3.7|4.9||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.9|-3.7|
91614455|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
91655621|NCT00290745|183203988|OTHER|||||||0.02|||||||Kruskal-Wallis|||||||0.02
91655622|NCT00290745|183203989|OTHER|||||||0.714|||||||Kruskal-Wallis|||||||0.714
91655623|NCT00290745|183203990|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91655624|NCT00290745|183203991|OTHER|||||||0.906|||||||Kruskal-Wallis|||||||0.906
91524219|NCT01576718|182923548|SUPERIORITY_OR_OTHER||LSM difference|2.99||||0.6258|TWO_SIDED|95.0|-9.06|15.05||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||15.05|-9.06|0.6258
91524220|NCT01576718|182923548|SUPERIORITY_OR_OTHER||LSM difference|0.39||||0.9487|TWO_SIDED|95.0|-11.6|12.39||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||12.39|-11.60|0.9487
91524221|NCT01576718|182923549|SUPERIORITY_OR_OTHER|||||||0.0341||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0341
91524222|NCT01576718|182923549|SUPERIORITY_OR_OTHER|||||||0.034||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0340
91524223|NCT01576718|182923549|SUPERIORITY_OR_OTHER|||||||0.0058||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0058
91524224|NCT01576718|182923549|SUPERIORITY_OR_OTHER|||||||0.0018||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0018
91524225|NCT01576718|182923549|SUPERIORITY_OR_OTHER|||||||0.1006||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.1006
91527412|NCT01003184|182930049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0497|TWO_SIDED|95.0|1.0|3.18|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.18|1.00|0.0497
91614456|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-2.4|
91614457|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
91614458|NCT00366548|183123142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
91614459|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
91655625|NCT03522948|183204028|SUPERIORITY||Mean Difference (Net)|-3.16|STANDARD_DEVIATION|-0.71||0.03|TWO_SIDED||||||t-test, 2 sided|||within-subject t-test||||.03
91655626|NCT03522948|183204029|SUPERIORITY||t-test|-1.34|STANDARD_DEVIATION|3.2||0.23|TWO_SIDED||||||t-test, 2 sided||||d = -0.51|||0.23
91655627|NCT03522948|183204030|SUPERIORITY||t-test|1.35|||<|0.05|TWO_SIDED|95.0|-0.69|2.41|||t-test, 2 sided|||GSAB self-efficacy||2.41|-0.69|<.05
91655628|NCT03522948|183204031|SUPERIORITY||t-test|2.93|||<|0.05|TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Test of GSAB self-efficacy subscale for condom use||3.41|0.31|<.05
91655629|NCT01984242|183204041|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9819|TWO_SIDED|95.0|0.69|1.45|||Log Rank|||||1.45|0.69|0.9819
91655630|NCT01984242|183204041|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.358|TWO_SIDED|95.0|0.82|1.71|||Log Rank|||||1.71|0.82|0.3580
91655631|NCT01984242|183204043|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0952||95.0|0.38|1.08|||Log Rank|||||1.08|0.38|0.0952
91655632|NCT01984242|183204043|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9172|TWO_SIDED|95.0|0.63|1.67|||Log Rank|||||1.67|0.63|0.9172
91655633|NCT01984242|183204045|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0153|TWO_SIDED|95.0|0.26|0.87|||Log Rank|||||0.87|0.26|0.0153
91655634|NCT01984242|183204045|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.5545|TWO_SIDED|95.0|0.48|1.46|||Log Rank|||||1.46|0.48|0.5545
91711516|NCT02171429|183314567|SUPERIORITY||Difference in Adjusted Means|0.0||||0.9931|TWO_SIDED|95.0|-9.2|9.1||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.1|-9.2|0.9931
91711517|NCT01724177|183314591|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:~H0: ORR ≤ 5% versus H1: ORR \> 5%"|Exact Test|||||||<0.0001
91711518|NCT03397121|183314599|SUPERIORITY||Mean Difference (Final Values)|-49.52|||<|0.0001|TWO_SIDED|95.0|-55.04|-43.99||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-43.99|-55.04|<.0001
91711519|NCT03397121|183314600|SUPERIORITY||Mean Difference (Final Values)|-44.3|||<|0.0001|TWO_SIDED|95.0|-48.48|-40.12||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.12|-48.48|<0.0001
91711520|NCT03397121|183314601|SUPERIORITY||Mean Difference (Final Values)|-68.89|||<|0.0001|TWO_SIDED|95.0|-77.11|-60.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-60.67|-77.11|<0.0001
91711521|NCT03397121|183314602|SUPERIORITY||Mean Difference (Final Values)|-62.74|||<|0.0001|TWO_SIDED|95.0|-69.01|-56.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-56.48|-69.01|<0.0001
91711522|NCT03397121|183314603|SUPERIORITY||Mean Difference (Final Values)|-78.34|||<|0.0001|TWO_SIDED|95.0|-83.65|-73.04||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-73.04|-83.65|<0.0001
91711523|NCT03397121|183314604|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-31.77|||<|0.0001|TWO_SIDED|95.0|-35.59|-27.94||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-27.94|-35.59|<0.0001
91711524|NCT03397121|183314605|SUPERIORITY||Mean Difference (Final Values)|-36.06|||<|0.0001|TWO_SIDED|95.0|-39.99|-32.14||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-32.14|-39.99|<0.0001
91711525|NCT03397121|183314606|SUPERIORITY||Mean Difference (Final Values)|-42.36|||<|0.0001|TWO_SIDED|95.0|-47.32|-37.4||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-37.40|-47.32|<0.0001
91711526|NCT04085601|183314611|SUPERIORITY||Difference|0.7311|||<|0.0001|TWO_SIDED|95.0|0.572|0.8902||Cochran-Mantel-Haenszel test is stratified by number of packed red blood cell (PRBC) within 12 months prior to screening (\<4, ≥ 4) reported in electronic data capture (EDC) data.|Cochran-Mantel-Haenszel|||||0.8902|0.572|<0.0001
91711527|NCT04085601|183314612|SUPERIORITY||LS mean difference|-1470.38|||<|0.0001|TWO_SIDED|95.0|-2113.44|-827.32||p-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-827.32|-2113.44|<0.0001
91711528|NCT04085601|183314613|SUPERIORITY||Difference|0.5411|||<|0.0001|TWO_SIDED|95.0|0.339|0.7431||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.7431|0.339|<0.0001
91524226|NCT01576718|182923550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.88116|TWO_SIDED|95.0|-11.12|12.91||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||12.91|-11.12|0.88116
91655635|NCT01984242|183204047|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0086|TWO_SIDED|95.0|0.28|0.84|||Log Rank|||||0.84|0.28|0.0086
91655636|NCT01984242|183204047|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7675||95.0|0.56|1.53|||Log Rank|||||1.53|0.56|0.7675
91711529|NCT04085601|183314614|SUPERIORITY||LS mean difference|-103.82||||0.0002|TWO_SIDED|95.0|-158.9|-48.74||P-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-48.74|-158.9|0.0002
91711530|NCT04085601|183314615|SUPERIORITY||LS mean difference|2.67||||0.0019|TWO_SIDED|95.0|0.99|4.35||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||4.35|0.99|0.0019
91711531|NCT04085601|183314616|SUPERIORITY||Difference|-0.7505|||<|0.0001|TWO_SIDED|95.0|-0.9041|-0.5969||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||-0.5969|-0.9041|<0.0001
91711532|NCT04085601|183314617|SUPERIORITY||Difference|0.7241|||<|0.0001|TWO_SIDED|95.0|0.5583|0.8899||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.8899|0.5583|<0.0001
91655637|NCT01984242|183204049|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1973||95.0|0.44|1.18|||Log Rank|||||1.18|0.44|0.1973
91655638|NCT01984242|183204049|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7738|TWO_SIDED|95.0|0.65|1.76|||Log Rank|||||1.76|0.65|0.7738
91655639|NCT01984242|183204051|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.083||95.0|0.43|1.06|||Log Rank|||||1.06|0.43|0.0830
91655640|NCT01984242|183204051|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7141|TWO_SIDED|95.0|0.7|1.69|||Log Rank|||||1.69|0.70|0.7141
91655641|NCT01984242|183204053|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2541||95.0|0.59|1.15|||Log Rank|||||1.15|0.59|0.2541
91655642|NCT01984242|183204053|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3103|TWO_SIDED|95.0|0.86|1.63|||Log Rank|||||1.63|0.86|0.3103
91655643|NCT01984242|183204055|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0351|TWO_SIDED|95.0|0.37|0.97|||Log Rank|||||0.97|0.37|0.0351
91655644|NCT01984242|183204055|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9769||95.0|0.64|1.54|||Log Rank|||||1.54|0.64|0.9769
91655645|NCT01984242|183204056|SUPERIORITY||Difference in response rates|2.97||||0.6492|TWO_SIDED|95.0|-10.68|16.62|||Cochran-Mantel-Haenszel|||||16.62|-10.68|0.6492
91711533|NCT04085601|183314618|SUPERIORITY||Median Difference (Net)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0||Wilcoxon rank-sum test p-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% confidence interval (CI) is constructed using Hodges-Lehmann Estimation of Location Shift.|Wilcoxon Rank-Sum Test|||||4|2|<0.0001
91711534|NCT04085601|183314619|SUPERIORITY||LS mean difference|4.51||||0.061|TWO_SIDED|95.0|-0.21|9.24||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||9.24|-0.21|0.061
91655646|NCT01984242|183204056|SUPERIORITY||Difference in response rates|-3.47||||0.5433||95.0|-16.63|9.69|||Cochran-Mantel-Haenszel|||||9.69|-16.63|0.5433
91655647|NCT01984242|183204057|SUPERIORITY||Difference in response rates|19.33||||0.0141|TWO_SIDED|95.0|-0.28|38.94|||Cochran-Mantel-Haenszel|||||38.94|-0.28|0.0141
91655648|NCT01984242|183204057|SUPERIORITY||Difference in response rates|1.11||||0.8719|TWO_SIDED|95.0|-17.02|19.24|||Cochran-Mantel-Haenszel|||||19.24|-17.02|0.8719
91655649|NCT01984242|183204058|SUPERIORITY||Difference in response rates|1.98||||0.8068|TWO_SIDED|95.0|-12.04|16.0|||Cochran-Mantel-Haenszel|||||16.00|-12.04|0.8068
91655650|NCT01984242|183204058|SUPERIORITY||Difference in response rates|-9.37||||0.1321||95.0|-22.61|3.87|||Cochran-Mantel-Haenszel|||||3.87|-22.61|0.1321
91655651|NCT01984242|183204059|SUPERIORITY||Difference in response rates|19.67||||0.0199|TWO_SIDED|95.0|-0.1|39.44|||Cochran-Mantel-Haenszel|||||39.44|-0.10|0.0199
91655652|NCT01984242|183204059|SUPERIORITY||Difference in response rates|-2.41||||0.7836|TWO_SIDED|95.0|-20.5|15.68|||Cochran-Mantel-Haenszel|||||15.68|-20.50|0.7836
91655653|NCT01984242|183204060|SUPERIORITY||Difference in response rates|3.96||||0.6231|TWO_SIDED|95.0|-10.23|18.15|||Cochran-Mantel-Haenszel|||||18.15|-10.23|0.6231
91655654|NCT01984242|183204060|SUPERIORITY||Difference in response rates|-8.42||||0.1816|TWO_SIDED|95.0|-21.86|5.02|||Cochran-Mantel-Haenszel|||||5.02|-21.86|0.1816
91655655|NCT01984242|183204061|SUPERIORITY||Difference in response rates|22.0||||0.0111|TWO_SIDED|95.0|2.11|41.89|||Cochran-Mantel-Haenszel|||||41.89|2.11|0.0111
91655656|NCT01984242|183204061|SUPERIORITY||Difference in response rates|-2.22||||0.8209|TWO_SIDED|95.0|-20.63|16.19|||Cochran-Mantel-Haenszel|||||16.19|-20.63|0.8209
91655657|NCT01984242|183204063|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0863||95.0|0.5|1.05|||Log Rank|||||1.05|0.50|0.0863
91655658|NCT01984242|183204063|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5922|TWO_SIDED|95.0|0.77|1.57|||Log Rank|||||1.57|0.77|0.5922
91655659|NCT01984242|183204065|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0021||95.0|0.25|0.75|||Log Rank|||||0.75|0.25|0.0021
91655660|NCT01984242|183204065|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6566|TWO_SIDED|95.0|0.56|1.44|||Log Rank|||||1.44|0.56|0.6566
91655661|NCT01984242|183204073|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.2867|TWO_SIDED|95.0|0.8|2.13|||Log Rank|||||2.13|0.80|0.2867
91655662|NCT01984242|183204073|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8039||95.0|0.65|1.73|||Log Rank|||||1.73|0.65|0.8039
91655663|NCT01984242|183204075|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.7879|TWO_SIDED|95.0|0.47|1.78|||Log Rank|||||1.78|0.47|0.7879
91655664|NCT01984242|183204075|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.9065|TWO_SIDED|95.0|0.52|1.8|||Log Rank|||||1.80|0.52|0.9065
91655665|NCT00449150|183204090|SUPERIORITY_OR_OTHER||LS means estimate|-0.198||||0.7424|TWO_SIDED|95.0|-1.38|0.98|||ANOVA|||||0.98|-1.38|0.7424
91655666|NCT00449150|183204090|SUPERIORITY_OR_OTHER||LS means estimate|0.055||||0.926||95.0|-1.1|1.21|||ANOVA|||||1.21|-1.10|0.926
91655667|NCT00449150|183204090|SUPERIORITY_OR_OTHER||LS means estimate|-0.252||||0.6699||95.0|-1.41|0.91|||ANOVA|||||0.91|-1.41|0.6699
91655668|NCT01089647|183204106|OTHER||||||=|0.946|||||||ANOVA|||Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.||||=0.946
91655669|NCT02364557|183204204|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|70.0|0.71|1.17||One-side significance level = 0.15|Log Rank||Reference level = SOC arm|Assuming an increase in median PFS from 10.5 to 19 months (HR: 0.55), 69 events provide \>90% power to conclude superiority with 1-sided α = 0.15.||1.17|0.71|0.36
91655670|NCT02364557|183204207|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.91|TWO_SIDED|95.0|0.59|1.61||Two-sided significance level = 0.05|Gray's test||Reference level = SOC arm|||1.61|0.59|0.91
91655671|NCT02364557|183204209|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9|TWO_SIDED|95.0|0.54|2.02||Two-sided significance level = 0.05.|Log Rank||Reference level = CTCs Absent|||2.02|0.54|0.90
91655672|NCT06052566|183204216|OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.61|1.54||||||||1.54|0.61|
91655673|NCT06052566|183204216|OTHER||Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.63|1.71||||||||1.71|0.63|
91655674|NCT06052566|183204217|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.6|1.65||||||||1.65|0.60|
91655675|NCT06052566|183204217|OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|90.0|0.53|1.65||||||||1.65|0.53|
91655676|NCT06052566|183204218|OTHER||Geometric Mean Ratio|0.73|||||TWO_SIDED|90.0|0.44|1.21||||||||1.21|0.44|
91655677|NCT06052566|183204218|OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.47|1.53||||||||1.53|0.47|
91655678|NCT00966953|183204257|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91655679|NCT02841709|183204261|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose response across placebo and all ACT-541468 doses. The null hypothesis of no dose response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
91655680|NCT02841709|183204261|OTHER||LS mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.73||0.258|TWO_SIDED|95.0|-14.7|4.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||4.0|-14.7|0.258
91655681|NCT02841709|183204261|OTHER||LS mean difference|-18.4|STANDARD_ERROR_OF_MEAN|4.76|<|0.001|TWO_SIDED|95.0|-27.8|-9.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||-9.0|-27.8|<0.001
91655682|NCT02841709|183204261|OTHER||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-40.9|-22.2|||Linear mixed effects model|||||-22.2|-40.9|<0.001
91524227|NCT01576718|182923550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.98||||0.05977|TWO_SIDED|95.0|-22.64|0.68||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||0.68|-22.64|0.05977
91524228|NCT01576718|182923550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.90426|TWO_SIDED|95.0|-13.02|11.54||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||11.54|-13.02|0.90426
91524229|NCT01576718|182923550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.4731|TWO_SIDED|95.0|-16.57|7.82||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||7.82|-16.57|0.47310
91524230|NCT01576718|182923557|SUPERIORITY_OR_OTHER||LSM difference|0.019|||=|0.6161|TWO_SIDED|95.0|-0.057|0.096||0.05 level of significance.|mixed model for repeated measures|||||0.096|-0.057|=0.6161
91614460|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.9||||||95.0|0.72|1.14||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.72|
91614461|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.85|1.1||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.85|
91614462|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.79|1.15||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.79|
91655683|NCT02841709|183204261|OTHER||LS mean difference|-47.8|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-57.2|-38.5|||Linear mixed effects model|||||-38.5|-57.2|<0.001
91655684|NCT01210001|183204263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.69|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.27|-0.69|<0.0001
91655685|NCT01210001|183204263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.82|-0.4||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.40|-0.82|<0.0001
91524231|NCT01576718|182923557|SUPERIORITY_OR_OTHER||LSM difference|0.004||||0.9245|TWO_SIDED|95.0|-0.973|0.08||0.05 level of significance.|mixed model for repeated measures|||||0.080|-0.973|0.9245
91524232|NCT01576718|182923557|SUPERIORITY_OR_OTHER||LSM difference|-0.008||||0.8434|TWO_SIDED|95.0|-0.083|0.068||0.05 level of significance.|mixed model for repeated measures|||||0.068|-0.083|0.8434
91524233|NCT01576718|182923557|SUPERIORITY_OR_OTHER||LSM difference|-0.047||||0.2241|TWO_SIDED|95.0|-0.122|0.029||0.05 level of significance.|mixed model for repeated measures|||||0.029|-0.122|0.2241
91524234|NCT01576718|182923557|SUPERIORITY_OR_OTHER||LSM difference|-0.053||||0.1822|TWO_SIDED|95.0|-0.13|0.025||0.05 level of significance.|mixed model for repeated measures|||||0.025|-0.130|0.1822
91524235|NCT01576718|182923558|SUPERIORITY_OR_OTHER||LSM difference|-5.56||||0.3568|TWO_SIDED|95.0|-17.42|6.29||0.05 level of significance.|Regression, Linear|||||6.29|-17.42|0.3568
91524236|NCT01576718|182923558|SUPERIORITY_OR_OTHER||LSM difference|-5.68||||0.3531|TWO_SIDED|95.0|-17.67|6.32||0.05 level of significance.|Regression, Linear|||||6.32|-17.67|0.3531
91524237|NCT01576718|182923558|SUPERIORITY_OR_OTHER||LSM difference|-6.58||||0.2724|TWO_SIDED|95.0|-18.35|5.19||0.05 level of significance.|Regression, Linear|||||5.19|-18.35|0.2724
91614463|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.98||||||95.0|0.86|1.13||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.86|
91614464|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.72|0.97||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.97|0.72|
91614465|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.71|0.98||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.98|0.71|
91614466|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.94||||||95.0|0.81|1.1||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.81|
91614467|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.93||||||95.0|0.83|1.04||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.83|
91614468|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.83|1.13||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.83|
91614469|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
91614470|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|1.05||||||95.0|0.93|1.18||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.93|
91614471|NCT00366548|183123145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.91||||||95.0|0.8|1.04||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.80|
91614472|NCT03650452|183123160|SUPERIORITY||Hodges-Lehmann Estimation|-30.48||||0.0007|TWO_SIDED|95.0|-46.99|-13.19||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed Analysis of Covariance (ANCOVA) adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-13.19|-46.99|0.0007
91614473|NCT03650452|183123161|SUPERIORITY||Hodges-Lehmann Estimate|-25.93||||0.0024|TWO_SIDED|95.0|-43.96|-10.69||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-10.69|-43.96|0.0024
91614474|NCT03650452|183123162|SUPERIORITY||Hodges-Lehmann Estimate|-50.0||||0.0001|TWO_SIDED|95.0|-75.03|-25.09||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-25.09|-75.03|0.0001
91614475|NCT03650452|183123163|SUPERIORITY||Hodges-Lehmann Estimate|-16.22||||0.147|TWO_SIDED|95.0|-39.5|4.49||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||4.49|-39.50|0.1470
91614476|NCT03650452|183123166|SUPERIORITY||Least Square (LS) Mean|0.1|STANDARD_DEVIATION|0.21||0.6829|TWO_SIDED|95.0|-0.32|0.49||The p-value is 2-sided and it is for the difference (TAK-935 - Placebo) of change from baseline between TAK-935 and Placebo was computed using MMRM.|Mixed-Model Repeated Measure (MMRM)||The MMRM model included treatment and visit as factors along with treatment\*visit interaction and baseline score as a covariate; and visit as repeated measure.|||0.49|-0.32|0.6829
91614477|NCT02531373|183123212|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-13.5|3.1||||||||3.1|-13.5|
91614478|NCT02531373|183123212|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-16.3|1.2||||||||1.2|-16.3|
91614479|NCT02531373|183123212|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-3.9|||||TWO_SIDED|95.0|-13.3|3.2||||||||3.2|-13.3|
91614480|NCT02531373|183123212|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-1.9|||||TWO_SIDED|95.0|-10.2|5.1||||||||5.1|-10.2|
91614481|NCT02531373|183123213|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
91614482|NCT02531373|183123213|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
91614483|NCT02531373|183123213|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.1||||||||7.1|-6.9|
91614484|NCT02531373|183123213|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|6.9||||||||6.9|-6.9|
91614485|NCT02531373|183123214|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|20.3||||0.029|TWO_SIDED|95.0|2.1|37.3|||Miettinen and Nurminen method|||||37.3|2.1|0.029
91614486|NCT02531373|183123214|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|22.3||||0.016|TWO_SIDED|95.0|4.3|39.1|||Miettinen and Nurminen method|||||39.1|4.3|0.016
91614487|NCT02531373|183123214|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|1.1||||0.908|TWO_SIDED|95.0|-17.7|19.9|||Miettinen and Nurminen method|||||19.9|-17.7|0.908
91614488|NCT02531373|183123214|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|23.1||||0.011|TWO_SIDED|95.0|5.4|39.6|||Miettinen and Nurminen method|||||39.6|5.4|0.011
91614489|NCT02531373|183123215|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-0.5||||0.943|TWO_SIDED|95.0|-14.0|12.9|||Miettinen and Nurminen method|||||12.9|-14.0|0.943
91614490|NCT02531373|183123215|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-2.5||||0.711|TWO_SIDED|95.0|-16.4|11.2|||Miettinen and Nurminen method|||||11.2|-16.4|0.711
91614491|NCT02531373|183123215|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|3.7||||0.529|TWO_SIDED|95.0|-8.7|16.4|||Miettinen and Nurminen method|||||16.4|-8.7|0.529
91614492|NCT02531373|183123215|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|5.8||||0.298|TWO_SIDED|95.0|-5.8|18.2|||Miettinen and Nurminen method|||||18.2|-5.8|0.298
91614493|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||Serotype 1||1.10|0.61|
91614494|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.77|||||TWO_SIDED|95.0|1.33|2.35||||||Serotype 3||2.35|1.33|
91614495|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.91|1.81||||||Serotype 4||1.81|0.91|
91614496|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.59|1.51||||||Serotype 5||1.51|0.59|
91614497|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.5||||||95.0|0.29|0.86||||||Serotype 6A||0.86|0.29|
91614498|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.1||||||Serotype 6B||2.10|0.58|
91614499|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.55|1.03||||||Serotype 7F||1.03|0.55|
91614500|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.74|1.75||||||Serotype 9V||1.75|0.74|
91614501|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.58|1.27||||||Serotype 14||1.27|0.58|
91614502|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.63||||||95.0|0.43|0.92||||||Serotype 18C||0.92|0.43|
91614503|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.64|1.26||||||Serotype 19A||1.26|0.64|
91614504|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||Serotype 19F||1.11|0.62|
91614505|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|81.47|||||TWO_SIDED|95.0|60.51|109.68||||||Serotype 22F (non-Prevnar serotype)||109.68|60.51|
91614506|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.56|1.47||||||Serotype 23F||1.47|0.56|
91614507|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|22.23|||||TWO_SIDED|95.0|11.77|41.97||||||Serotype 33F (non-Prevnar serotype)||41.97|11.77|
91614508|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.68|1.23||||||Serotype 1||1.23|0.68|
91614509|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|1.6|2.8||||||Serotype 3||2.80|1.60|
91614510|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.82|1.62||||||Serotype 4||1.62|0.82|
91655686|NCT01210001|183204264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.48|STANDARD_ERROR_OF_MEAN|3.71|<|0.0001|TWO_SIDED|97.5|-31.81|-15.15||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo|||-15.15|-31.81|<0.0001
91614511|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.53|1.31||||||Serotype 5||1.31|0.53|
91614512|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.54|||||TWO_SIDED|95.0|0.31|0.92||||||Serotype 6A||0.92|0.31|
91614513|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.42|1.5||||||Serotype 6B||1.50|0.42|
91614514|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||Serotype 7F||1.31|0.71|
91614515|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.64|1.49||||||Serotype 9V||1.49|0.64|
91655687|NCT01210001|183204264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.46|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|97.5|-36.73|-20.19||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo|||-20.19|-36.73|<0.0001
91655688|NCT01210001|183204265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.64|-1.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo|||-1.27|-2.64|<0.0001
91655689|NCT01210001|183204265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.49|-1.13||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 25mg minus placebo|||-1.13|-2.49|<0.0001
91655690|NCT01210001|183204266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.69|-0.21||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.21|-0.69|<0.0001
91614516|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.37||||||Serotype 14||1.37|0.63|
91614517|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.55|1.16||||||Serotype 18C||1.16|0.55|
91614518|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.63|1.22||||||Serotype 19A||1.22|0.63|
91614519|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.81|1.44||||||Serotype 19F||1.44|0.81|
91614520|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|89.87|||||TWO_SIDED|95.0|67.02|120.51||||||Serotype 22F (non-Prevnar serotype)||120.51|67.02|
91614521|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.61|1.57||||||Serotype 23F||1.57|0.61|
91614522|NCT02531373|183123216|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|18.38|||||TWO_SIDED|95.0|9.82|34.41||||||Serotype 33F (non-Prevnar serotype)||34.41|9.82|
91614523|NCT04705597|183123225|SUPERIORITY||Odds Ratio (OR)|1.366||||0.3312|TWO_SIDED|95.0|0.728|2.562|||Regression, Logistic|||||2.562|0.728|0.3312
91614524|NCT04705597|183123227|SUPERIORITY||Odds Ratio (OR)|0.574||||0.4561|TWO_SIDED|95.0|0.133|2.475|||Regression, Logistic|||Day 14||2.475|0.133|0.4561
91614525|NCT04705597|183123227|SUPERIORITY||Odds Ratio (OR)|0.521||||0.1559|TWO_SIDED|95.0|0.212|1.282|||Regression, Logistic|||Day 28||1.282|0.212|0.1559
91614526|NCT04705597|183123227|SUPERIORITY||Odds Ratio (OR)|0.498||||0.1293|TWO_SIDED|95.0|0.203|1.226|||Regression, Logistic|||Day 57||1.226|0.203|0.1293
91614527|NCT04705597|183123228|SUPERIORITY|||||||0.2687|||||||Log Rank|||Statistical analysis was only performed for Day 28. This is timeframe used for the primary endpoint||||0.2687
91614528|NCT04705597|183123229|SUPERIORITY|||||||0.3977|||||||Log Rank|||||||0.3977
91614529|NCT04705597|183123230|SUPERIORITY|||||||0.2229|||||||Log Rank|||||||0.2229
91614530|NCT04705597|183123231|SUPERIORITY||Odds Ratio (OR)|1.388||||0.2941|TWO_SIDED|95.0|0.752|2.561|||Regression, Logistic|||||2.561|0.752|0.2941
91614531|NCT04705597|183123232|SUPERIORITY|||||||0.3325|||||||Log Rank|||||||0.3325
91655691|NCT01210001|183204266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.83|-0.36||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.36|-0.83|<0.0001
91711535|NCT04085601|183314620|SUPERIORITY||Difference|0.3645||||0.001|TWO_SIDED|95.0|0.1648|0.5642|||Cochran-Mantel-Haenszel|||||0.5642|0.1648|0.001
91655692|NCT04526210|183204282|OTHER||Geometric least square (LS) mean ratio|0.98|||||TWO_SIDED|90.0|0.9415|1.0205||||||||1.0205|0.9415|
91711536|NCT04085601|183314621|SUPERIORITY||Difference|0.5592|||<|0.0001|TWO_SIDED|95.0|0.3682|0.7502|||Cochran-Mantel-Haenszel|||||0.7502|0.3682|<0.0001
91711537|NCT04085601|183314622|SUPERIORITY||LS mean difference|21.75||||0.0006|TWO_SIDED|95.0|9.35|34.16||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||34.16|9.35|0.0006
91711538|NCT04085601|183314623|SUPERIORITY||LS mean difference|55.79||||0.005|TWO_SIDED|95.0|16.83|94.74||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||94.74|16.83|0.005
91711539|NCT04085601|183314624|SUPERIORITY||Difference|0.4639||||0.0002|TWO_SIDED|95.0|0.2529|0.675||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.675|0.2529|0.0002
91711540|NCT04085601|183314625|SUPERIORITY||Stratified Hazard Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.004|0.091||Hazard ratio is based on cox proportional hazards model.|Stratified Wilcoxon|||||0.091|0.004|<0.0001
91711541|NCT04085601|183314626|SUPERIORITY||Stratified Hazard Ratio|0.025|||<|0.0001|TWO_SIDED|95.0|0.005|0.121|||Stratified Wilcoxon|||||0.121|0.005|<0.0001
91711542|NCT03492437|183314627|OTHER||Ratio of Geometric Least square Mean|151.38|||||TWO_SIDED|90.0|127.35|179.93||||||||179.93|127.35|
91711543|NCT03492437|183314628|OTHER||Ratio of Geometric Least square Mean|144.7|||||TWO_SIDED|90.0|122.89|170.39||||||||170.39|122.89|
91711544|NCT03492437|183314629|OTHER||Ratio of Geometric Least square Mean|138.45|||||TWO_SIDED|90.0|121.59|157.65||||||||157.65|121.59|
91711545|NCT03492437|183314630|OTHER||Median Difference (Net)|0.5|||||TWO_SIDED|90.0|-0.3|1.0||||||||1.0|-0.3|
91711546|NCT00572455|183314662|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|3.02||||0.028|TWO_SIDED|90.0|0.78|5.25|||ANCOVA|||Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.25|0.78|0.028
91711547|NCT00572455|183314662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|||<|0.001|TWO_SIDED|90.0|2.5|6.96|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.96|2.50|<0.001
91711548|NCT00572455|183314662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.56|||<|0.001|TWO_SIDED|90.0|4.33|8.79|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.79|4.33|<0.001
91711549|NCT00572455|183314662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|||<|0.001|TWO_SIDED|90.0|3.6|7.95|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.95|3.60|<0.001
91711550|NCT00572455|183314662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.06|||<|0.001|TWO_SIDED|90.0|2.74|7.37|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.37|2.74|<0.001
91711551|NCT00572455|183314662|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.02|||<|0.001|TWO_SIDED|90.0|3.79|8.25|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.25|3.79|<0.001
91711552|NCT00572455|183314663|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.06||||0.171|TWO_SIDED|90.0|-0.21|2.32|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.32|-0.21|0.171
91614532|NCT04705597|183123233|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.0254|TWO_SIDED|95.0|0.08|1.2||Change at Day 14|ANCOVA|||||1.2|0.08|0.0254
91614533|NCT04705597|183123233|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.1109|TWO_SIDED|95.0|-0.12|1.18|||ANCOVA|||Change at Day 28||1.18|-0.12|0.1109
91614534|NCT04705597|183123233|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.864|TWO_SIDED|95.0|-0.1|0.12|||ANCOVA|||Change at Day 57||0.12|-0.10|0.8640
91614535|NCT04705597|183123234|SUPERIORITY||Odds Ratio (OR)|2.046||||0.0919|TWO_SIDED|95.0|0.89|4.706|||Regression, Logistic|||||4.706|0.89|0.0919
91614536|NCT04705597|183123235|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.749|TWO_SIDED|95.0|-0.42|8.08|||ANCOVA|||||8.08|-0.42|0.749
91614537|NCT04705597|183123236|SUPERIORITY||Mean Difference (Final Values)|3.69||||0.1769|TWO_SIDED|95.0|-1.75|9.13|||ANCOVA|||||9.13|-1.75|0.1769
91614538|NCT04705597|183123237|SUPERIORITY||Odds Ratio (OR)|0.54||||0.2621|TWO_SIDED|95.0|0.184|1.586|||Regression, Logistic|||||1.586|0.184|0.2621
91614539|NCT04705597|183123238|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.2265|TWO_SIDED|95.0|-1.76|7.37|||ANCOVA|||||7.37|-1.76|0.2265
91614540|NCT04705597|183123239|SUPERIORITY||Odds Ratio (OR)|1.223||||0.5497|TWO_SIDED|95.0|0.633|2.364|||Regression, Logistic|||||2.364|0.633|0.5497
91614541|NCT04705597|183123240|SUPERIORITY||Mean Difference (Final Values)|4.89||||0.1172|TWO_SIDED|95.0|-1.27|11.05|||ANCOVA|||||11.05|-1.27|0.1172
91614542|NCT04705597|183123241|SUPERIORITY||Odds Ratio (OR)|0.914||||0.853|TWO_SIDED|95.0|0.353|2.368|||Regression, Logistic|||||2.368|0.353|0.853
91614543|NCT04705597|183123242|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.1991|TWO_SIDED|95.0|-1.86|8.18|||ANCOVA|||||8.18|-1.86|0.1991
91614544|NCT04705597|183123243|SUPERIORITY||Odds Ratio (OR)|4.103||||0.0166|TWO_SIDED|95.0|1.293|13.027|||Regression, Logistic|||||13.027|1.293|0.0166
91655693|NCT04526210|183204283|OTHER||Geometric LS mean ratio|0.978|||||TWO_SIDED|90.0|0.9344|1.0244||||||||1.0244|0.9344|
91655694|NCT04526210|183204284|OTHER||Geometric LS mean ratio|0.981|||||TWO_SIDED|90.0|0.9368|1.0269||||||||1.0269|0.9368|
91524238|NCT01576718|182923558|SUPERIORITY_OR_OTHER||LSM difference|-5.11|||=|0.3964|TWO_SIDED|95.0|-16.95|6.72||0.05 level of significance.|Regression, Linear|||||6.72|-16.95|=0.3964
91524239|NCT01576718|182923558|SUPERIORITY_OR_OTHER||LSM difference|-13.45||||0.0296|TWO_SIDED|95.0|-25.57|-1.33||0.05 level of significance.|Regression, Linear|||||-1.33|-25.57|0.0296
91524240|NCT01576718|182923559|SUPERIORITY_OR_OTHER||LSM difference|-0.69||||0.9101|TWO_SIDED|95.0|-12.59|11.22||0.05 level of significance.|Regression, Linear|||||11.22|-12.59|0.9101
91524241|NCT01576718|182923559|SUPERIORITY_OR_OTHER||LSM difference|-4.51||||0.4634|TWO_SIDED|95.0|-16.6|7.57||0.05 level of significance.|Regression, Linear|||||7.57|-16.6|0.4634
91524242|NCT01576718|182923559|SUPERIORITY_OR_OTHER||LSM difference|-5.88||||0.3333|TWO_SIDED|95.0|-17.8|6.05||0.05 level of significance.|Regression, Linear|||||6.05|-17.8|0.3333
91524243|NCT01576718|182923559|SUPERIORITY_OR_OTHER||LSM difference|-8.19||||0.1763|TWO_SIDED|95.0|-20.06|3.69||0.05 level of significance.|Regression, Linear|||||3.69|-20.06|0.1763
91524244|NCT01576718|182923559|SUPERIORITY_OR_OTHER||Slope|-9.05||||0.1469|TWO_SIDED|95.0|-21.3|3.19||0.05 level of significance.|Regression, Linear|||||3.19|-21.3|0.1469
91524245|NCT01742364|182923570|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.475
91524246|NCT01742364|182923570|SUPERIORITY_OR_OTHER|||||||0.187|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.187
91524247|NCT01742364|182923572|SUPERIORITY_OR_OTHER|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.205
91524248|NCT01742364|182923573|SUPERIORITY_OR_OTHER|||||||0.325|||||||Wilcoxon (Mann-Whitney)|||||||0.325
91524249|NCT01742364|182923574|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91524250|NCT01742364|182923574|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.130
91524251|NCT01742364|182923575|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
91614545|NCT04705597|183123244|SUPERIORITY||Mean Difference (Final Values)|4.56||||0.1297|TWO_SIDED|95.0|-1.51|10.64|||ANCOVA|||||10.64|-1.51|0.1297
91614546|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.1916|TWO_SIDED|95.0|-0.35|0.07|||ANCOVA|||Baseline||0.07|-0.35|0.1916
91614547|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1097|TWO_SIDED|95.0|-0.44|0.05|||ANCOVA|||Treatment Day 2||0.05|-0.44|0.1097
91614548|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0276|TWO_SIDED|95.0|-0.63|-0.04|||ANCOVA|||Treatment Day 3||-0.04|-0.63|0.0276
91524252|NCT01742364|182923575|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
91614549|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0463|TWO_SIDED|95.0|-0.71|-0.01|||ANCOVA|||Treatment Day 4||-0.01|-0.71|0.0463
91524253|NCT02821819|182923597|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|8.1||0.8|ONE_SIDED|||||a priori threshold for statistical significance: \<0.05|t-test, 1 sided|||The sample size was calculated assuming a non-inferiority margin of 5 eggs and a standard deviation (SD) of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|"Since the number of collected eggs constitutes the main outcome of the study, the sample size was calculated assuming a non-inferiority margin of 5 eggs with an standard deviation of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).~Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant."|||0.8
91524254|NCT02821819|182923597|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|Mean Difference (Final Values)|82.0||||0.8|TWO_SIDED|||||a priori threshold for statistical significance: \<0.05|Chi-squared|||The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.||||0.8
91524255|NCT02821819|182923598|NON_INFERIORITY|Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant.|Median Difference (Final Values)|71.1|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91527413|NCT01003184|182930050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0074|TWO_SIDED|95.0|1.24|3.96|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.96|1.24|0.0074
91527414|NCT01003184|182930051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.89||||0.0002|TWO_SIDED|95.0|2.1|11.35|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||11.35|2.10|0.0002
91614550|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0969|TWO_SIDED|95.0|-0.71|0.06|||ANCOVA|||Treatment Day 5||0.06|-0.71|0.0969
91614551|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.4367|TWO_SIDED|95.0|-0.57|0.25|||ANCOVA|||Treatment Day 6||0.25|-0.57|0.4367
91614552|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6685|TWO_SIDED|95.0|-0.54|0.35|||ANCOVA|||Treatment Day 7||0.35|-0.54|0.6685
91614553|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2287|TWO_SIDED|95.0|-0.73|0.18|||ANCOVA|||Treatment Day 8||0.18|-0.73|0.2287
91614554|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.1061|TWO_SIDED|95.0|-0.96|0.09|||ANCOVA|||Treatment Day 9||0.09|-0.96|0.1061
91614555|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.0415|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|||Treatment Day 10||-0.02|-1.06|0.0415
91524256|NCT02332590|182923600|SUPERIORITY||LS Mean Difference|-1.077|||<|0.0001|TWO_SIDED|95.0|-1.361|-0.793||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline DAS28-ESR score as a continuous covariate. Hierarchical testing procedure was used to control overall alpha error rate at 0.05 level and handle multiple endpoint analyses. Testing was then performed sequentially in order endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-0.793|-1.361|<0.0001
91524257|NCT02332590|182923601|SUPERIORITY||Odds Ratio (OR)|4.879|||<|0.0001|TWO_SIDED|95.0|2.536|9.389||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||9.389|2.536|<0.0001
91524258|NCT02332590|182923602|SUPERIORITY||Odds Ratio (OR)|1.976||||0.0017|TWO_SIDED|95.0|1.289|3.028||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||3.028|1.289|0.0017
91524259|NCT02332590|182923603|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0036|TWO_SIDED|95.0|1.3|4.02||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||4.020|1.300|0.0036
91524260|NCT02332590|182923604|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0074|TWO_SIDED|95.0|1.168|2.773||Threshold for significance 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||2.773|1.168|0.0074
91524261|NCT02332590|182923605|SUPERIORITY||LS Mean Difference|-0.182||||0.0037|TWO_SIDED|95.0|-0.305|-0.059||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI score as a continuous covariate.||-0.059|-0.305|0.0037
91524262|NCT02332590|182923606|SUPERIORITY||LS Mean Difference|2.65||||0.0006|TWO_SIDED|95.0|1.147|4.153||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline SF-36 PCS score as a continuous covariate.||4.153|1.147|0.0006
91524263|NCT02332590|182923607|SUPERIORITY||LS Mean Difference|1.768||||0.0689|TWO_SIDED|95.0|-0.137|3.674||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline FACIT-F score as a continuous covariate.||3.674|-0.137|0.0689
91524264|NCT00811382|182923669|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91524265|NCT00975221|182923712|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH) statistic|39.866|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91524266|NCT00975221|182923713|SUPERIORITY_OR_OTHER||CMH statistic|40.953|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91524267|NCT00975221|182923714|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-13.55|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|-16.23|-10.88|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-10.88|-16.23|<0.001
91524268|NCT00975221|182923715|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.79|STANDARD_ERROR_OF_MEAN|5.61|<|0.001|TWO_SIDED|95.0|-34.01|-11.57|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-11.57|-34.01|<0.001
91527415|NCT01003184|182930052|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.257||0.6993|TWO_SIDED|95.0|-0.41|0.61|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.61|-0.41|0.6993
91655695|NCT00090857|183204295|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.15
91655696|NCT00090857|183204296|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.70
91655697|NCT00090857|183204297|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.03
91711553|NCT00572455|183314663|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.553|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.553
91711554|NCT00572455|183314663|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.555|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.555
91711555|NCT00572455|183314663|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.053|TWO_SIDED|90.0|0.22|2.73|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.73|0.22|0.053
91711556|NCT00572455|183314663|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.54|||<|0.001|TWO_SIDED|90.0|1.29|3.8|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.80|1.29|<0.001
91711557|NCT00572455|183314663|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.81||||0.018|TWO_SIDED|90.0|0.56|3.07|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.07|0.56|0.018
91711558|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.62||||0.011|TWO_SIDED|90.0|1.34|5.9|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.90|1.34|0.011
91711559|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.19||||0.004|TWO_SIDED|90.0|1.91|6.47|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.47|1.91|0.004
91711560|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.47|||<|0.001|TWO_SIDED|90.0|4.19|8.75|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|4.19|<0.001
91711561|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.32|||<|0.001|TWO_SIDED|90.0|3.11|7.54|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.54|3.11|<0.001
91711562|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.0|||<|0.001|TWO_SIDED|90.0|3.66|8.33|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|3.66|<0.001
91711563|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.8|||<|0.001|TWO_SIDED|90.0|3.52|8.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.08|3.52|<0.001
91711564|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.44||||0.12|TWO_SIDED|90.0|-0.14|5.02|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|-0.14|0.120
91711565|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.005|TWO_SIDED|90.0|1.97|7.14|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.14|1.97|0.005
91711566|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.17|||<|0.001|TWO_SIDED|90.0|3.58|8.75|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|3.58|<0.001
91711567|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.03|||<|0.001|TWO_SIDED|90.0|3.52|8.54|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.54|3.52|<0.001
91711568|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.31|||<|0.001|TWO_SIDED|90.0|4.66|9.95|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.95|4.66|<0.001
91711569|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.5|||<|0.001|TWO_SIDED|90.0|2.91|8.08|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.||8.08|2.91|<0.001
91711570|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.04||||0.009|TWO_SIDED|90.0|1.56|6.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.53|1.56|0.009
91527416|NCT01003184|182930053|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.72|STANDARD_ERROR_OF_MEAN|1.853||0.0116|TWO_SIDED|95.0|-8.37|-1.07|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-1.07|-8.37|0.0116
91711571|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.0|||<|0.001|TWO_SIDED|90.0|4.49|9.5|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.49|<0.001
91711572|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.61|||<|0.001|TWO_SIDED|90.0|5.11|10.11|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.11|5.11|<0.001
91711573|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.64|9.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.53|4.64|<0.001
91711574|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.01|||<|0.001|TWO_SIDED|90.0|3.4|8.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.62|3.40|<0.001
91614556|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.1236|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Treatment Day 11||0.12|-1.00|0.1236
91527704|NCT01976364|182930497|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-1.0|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-1.0|
91655698|NCT00090857|183204298|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.06
91655699|NCT00090857|183204299|SUPERIORITY_OR_OTHER|||||||0.38|||||||Fisher Exact|||||||0.38
91655700|NCT00090857|183204300|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
91655701|NCT00090857|183204301|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
91655702|NCT00090857|183204302|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
91655703|NCT00090857|183204303|SUPERIORITY_OR_OTHER|||||||0.27|||||||Fisher Exact|||||||0.27
91655704|NCT00090857|183204304|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||.60
91655705|NCT00090857|183204305|SUPERIORITY_OR_OTHER|||||||0.58|||||||Fisher Exact|||||||.58
91655706|NCT00090857|183204306|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
91655707|NCT05097326|183204310|OTHER|||||||0.44||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of total contractions||||0.44
91655708|NCT05097326|183204310|OTHER|||||||0.02||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of contractions per hour||||0.02
91655709|NCT05097326|183204311|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison at 12 hours after labor induction||||0.04
91655710|NCT05097326|183204311|OTHER|||||||0.17||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison of uterine tachysystole of total labor duration||||0.17
91655711|NCT05097326|183204312|OTHER|||||||0.63||||||a p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.63
91655712|NCT05097326|183204313|OTHER|||||||0.01||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.01
91655713|NCT05097326|183204314|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at complete cervical dilation||||0.04
91655714|NCT05097326|183204315|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at postpartum transfer||||0.04
91655715|NCT05097326|183204316|OTHER|||||||0.68||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.68
91655716|NCT05097326|183204317|OTHER|||||||1||||||A p-value of \<0.05 would be considered significant.|Fisher Exact|||||||1
91655717|NCT05097326|183204318|OTHER|||||||1||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||1
91655718|NCT05097326|183204319|OTHER|||||||0.9||||||A p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.90
91655719|NCT05097326|183204320|OTHER|||||||0.17||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||1 minute APGAR score||||0.17
91655720|NCT05097326|183204320|OTHER|||||||1||||||A p-value of \<0.05 would be statistically significant.|Fisher Exact|||APGAR score at 5 minutes||||1
91655721|NCT05097326|183204321|OTHER|||||||0.22||||||A p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.22
91655722|NCT03480425|183204322|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.4|<|0.05|TWO_SIDED|95.0|-2.4|2.6|||t-test, 2 sided|||||2.6|-2.4|<0.05
91655723|NCT02753842|183204324|SUPERIORITY||Mean Difference (Final Values)|1.39|||<|0.05|TWO_SIDED|95.0|0.52|2.26||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing fitted to standard condoms, the null hypothesis was no difference in pleasure.||2.26|0.52|<0.05
91655724|NCT02753842|183204325|SUPERIORITY||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.92|1.38|||Mixed Models Analysis|||A single item assessed whether participants preferred fitted condoms or standard condoms at the end of the study (the item word viewed by participants used the blinded identifiers of each condom type).||1.38|0.92|>0.05
91655725|NCT02753842|183204327|SUPERIORITY||Odds Ratio (OR)|0.93|||>|0.05|TWO_SIDED|95.0|0.27|3.24|||logistic mixed effects model|||We assessed clinical condom failure for anal sex, comparing anal sex acts with fitted condoms to anal sex acts with standard condoms.||3.24|0.27|>0.05
91655726|NCT02753842|183204328|SUPERIORITY||Median Difference (Final Values)|1.06|||<|0.05|TWO_SIDED|95.0|0.18|1.94||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing thin to standard condoms, the null hypothesis was no difference in pleasure.||1.94|0.18|<0.05
91655727|NCT05216081|183204329|OTHER||Percentage of enrolled from eligible|69.4|||||TWO_SIDED|95.0|61.5|76.2||||||||76.2|61.5|
91655728|NCT05216081|183204330|OTHER||Percentage of enrolled from eligible|99.0|||||TWO_SIDED|95.0|94.7|99.8||||||||99.8|94.7|
91655729|NCT05216081|183204332|OTHER||Percentage screened positive for EM|15.8|||||TWO_SIDED|95.0|10.0|24.2||||||||24.2|10|
91655730|NCT05216081|183204335|OTHER||Percentage who self-disclosed|57.1|||||TWO_SIDED|95.0|32.6|78.6||||||||78.6|32.6|
91655731|NCT05216081|183204336|OTHER||Percentage substantiated by socialworker|75.0|||||TWO_SIDED|95.0|50.5|89.8||||||||89.8|50.5|
91655732|NCT03292653|183204342|SUPERIORITY||Difference in Least Squares (LS) Means|1.26|STANDARD_ERROR_OF_MEAN|3.64||0.736|TWO_SIDED|90.0|-5.4|7.93|||ANCOVA|||Analysis of Covariance (ANCOVA) model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||7.93|-5.4|0.736
91655733|NCT03292653|183204342|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|3.38||0.7694|TWO_SIDED|90.0|-7.22|5.18|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.18|-7.22|0.7694
91614557|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0097|TWO_SIDED|95.0|-1.23|-0.18|||ANCOVA|||Treatment Day 12||-0.18|-1.23|0.0097
91614558|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.0157|TWO_SIDED|95.0|-1.02|-0.11|||ANCOVA|||Treatment Day 13||-0.11|-1.02|0.0157
91711575|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|||<|0.001|TWO_SIDED|90.0|6.11|11.3|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.30|6.11|<0.001
91614559|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.001|TWO_SIDED|95.0|-1.32|-0.36|||ANCOVA|||Treatment Day 14||-0.36|-1.32|0.0010
91614560|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.644|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Time of Discharge Visit||0.25|-0.40|0.6440
91614561|NCT04705597|183123245|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9869|TWO_SIDED|95.0|-0.6|0.59|||ANCOVA|||Follow up Day 28||0.59|-0.60|0.9869
91614562|NCT04705597|183123246|SUPERIORITY||Mean Difference (Final Values)|1.69||||0.2399|TWO_SIDED|95.0|-1.14|4.52|||ANCOVA|||||4.52|-1.14|0.2399
91614563|NCT04705597|183123247|SUPERIORITY||Odds Ratio (OR)|0.869||||0.8081|TWO_SIDED|95.0|0.28|2.695|||Regression, Logistic|||||2.695|0.28|0.8081
91614564|NCT04705597|183123248|SUPERIORITY||Odds Ratio (OR)|1.436||||0.3193|TWO_SIDED|95.0|0.704|2.929|||Regression, Logistic|||||2.929|0.704|0.3193
91614565|NCT00390780|183123249|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025|one-sided test|||"Analyses for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
91527705|NCT01976364|182930497|OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|0.0|2.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.3|0.0|
91614566|NCT00390780|183123250|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|one-sided noninferiority test|||"Analysis for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
91614567|NCT00390780|183123251|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.0974|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.0974
91614568|NCT00390780|183123251|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|Compare proportion of clinical success|0.15||||0.1115|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.1115
91614569|NCT00390780|183123252|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.8787|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.8787
91614570|NCT00390780|183123252|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.7969|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.7969
91614571|NCT00390780|183123253|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.882|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.8820
91655734|NCT03292653|183204343|SUPERIORITY||Difference in LS Means|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.184|TWO_SIDED|90.0|-0.09|0.01|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.01|-0.09|0.184
91655735|NCT03292653|183204343|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3397|TWO_SIDED|90.0|-0.07|0.02|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.02|-0.07|0.3397
91655736|NCT03292653|183204344|SUPERIORITY||Difference in LS Means|-17.07|STANDARD_ERROR_OF_MEAN|9.12||0.094|TWO_SIDED|90.0|-33.79|-0.35|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||-0.35|-33.79|0.094
91655737|NCT03292653|183204344|SUPERIORITY||Difference in LS Means|-12.09|STANDARD_ERROR_OF_MEAN|8.49||0.1878|TWO_SIDED|90.0|-27.65|3.46|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.46|-27.65|0.1878
91655738|NCT03292653|183204345|SUPERIORITY||Difference in LS Means|-4.82|STANDARD_ERROR_OF_MEAN|5.8||0.4269|TWO_SIDED|90.0|-15.45|5.8|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.8|-15.45|0.4269
91655739|NCT03292653|183204345|SUPERIORITY||Difference in LS Means|-6.36|STANDARD_ERROR_OF_MEAN|5.39||0.2684|TWO_SIDED|90.0|-16.24|3.52|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.52|-16.24|0.2684
91711576|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.66||||0.066|TWO_SIDED|90.0|0.29|5.02|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|0.29|0.066
91711577|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.13||||0.006|TWO_SIDED|90.0|1.76|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.76|0.006
91711578|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.13|||<|0.001|TWO_SIDED|90.0|3.76|8.49|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.49|3.76|<0.001
91711579|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.81|||<|0.001|TWO_SIDED|90.0|3.51|8.11|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.51|<0.001
91711580|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.02||||0.01|TWO_SIDED|90.0|1.53|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.53|0.010
91711581|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.48|||<|0.001|TWO_SIDED|90.0|3.03|7.93|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.93|3.03|<0.001
91711582|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.006|TWO_SIDED|90.0|1.91|7.19|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.19|1.91|0.006
91524269|NCT04022889|182923716|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|7.7|||TWO_SIDED|95.0|-3.5|6.2|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||6.2|-3.5|
91614572|NCT00390780|183123253|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.9033|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.9033
91614573|NCT00390780|183123254|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion mycologic cure|0.15||||0.5816|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.5816
91711583|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.3||||0.002|TWO_SIDED|90.0|2.66|7.94|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.94|2.66|0.002
91711584|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.51|||<|0.001|TWO_SIDED|90.0|4.87|10.16|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.16|4.87|<0.001
91614574|NCT00390780|183123254|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population|difference in proportion mycologic cure|0.15||||0.4439|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.4439
91711585|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14|||<|0.001|TWO_SIDED|90.0|6.57|11.71|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.71|6.57|<0.001
91711586|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.69||||0.002|TWO_SIDED|90.0|2.94|8.44|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.44|2.94|0.002
91711587|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.89|||<|0.001|TWO_SIDED|90.0|4.16|9.62|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.62|4.16|<0.001
91711588|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.269|TWO_SIDED|90.0|-0.91|4.58|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.58|-0.91|0.269
91711589|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.49||||0.009|TWO_SIDED|90.0|1.75|7.24|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.24|1.75|0.009
91711590|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.83|||<|0.001|TWO_SIDED|90.0|4.08|9.57|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.57|4.08|<0.001
91711591|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.18|||<|0.001|TWO_SIDED|90.0|3.52|8.84|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.84|3.52|<0.001
91711592|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.52||||0.002|TWO_SIDED|90.0|2.71|8.33|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|2.71|0.002
91711593|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.76|||<|0.001|TWO_SIDED|90.0|4.01|9.5|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.01|<0.001
91524270|NCT04022889|182923716|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|8.9|||TWO_SIDED|95.0|-6.4|4.8|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||4.8|-6.4|
91614575|NCT00390780|183123255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion relapsed|0.15||||0.833|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.8330
91614576|NCT00390780|183123255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population.|difference in proportion relapsed|0.15||||0.9738|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.9738
91614577|NCT00390780|183123260|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups||||0.1860
91614578|NCT00390780|183123260|SUPERIORITY_OR_OTHER|||||||0.9564||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups||||0.9564
91614579|NCT00305006|183123262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0||||ANOVA|ANOVA|||ANOVA||||<0.01
91614580|NCT01996319|183123264|SUPERIORITY_OR_OTHER||null hypoth|0.2021|||<|0.0001|TWO_SIDED|95.0|0.1583|0.246|||ANCOVA|||||0.2460|0.1583|<0.0001
91614581|NCT01996319|183123265|SUPERIORITY_OR_OTHER||Null hypoth|36.7126||||0.0399|TWO_SIDED|95.0|1.7241|71.7011|||ANCOVA|||||71.7011|1.7241|0.0399
91614582|NCT01671085|183123282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.49|||<|0.001|TWO_SIDED|90.0|-71.27|-29.7||P-value is for Day 43.|Mixed Effects Model Analysis|||||-29.70|-71.27|<0.001
91614583|NCT01671085|183123282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.11|||<|0.001|TWO_SIDED|90.0|-65.91|-24.31||P-value is for Day 57.|Mixed Effects Models Analysis|||||-24.31|-65.91|<0.001
91614584|NCT00637273|183123283|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|0.37|0.89||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.89|0.37|<.0001
91614585|NCT00637273|183123283|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.131||0.0165|TWO_SIDED|95.0|0.06|0.57||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.57|0.06|0.0165
91614586|NCT00637273|183123284|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
91614587|NCT00637273|183123284|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0015
91711594|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.36||||0.024|TWO_SIDED|90.0|0.95|5.76|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.76|0.95|0.024
91711595|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.24|||<|0.001|TWO_SIDED|90.0|2.82|7.66|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.66|2.82|<0.001
91711596|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.64|||<|0.001|TWO_SIDED|90.0|4.23|9.06|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.06|4.23|<0.001
91711597|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.22|||<|0.001|TWO_SIDED|90.0|2.87|7.58|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.58|2.87|<0.001
91711598|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.88||||0.012|TWO_SIDED|90.0|1.39|6.37|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.37|1.39|0.012
91711599|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.98|||<|0.001|TWO_SIDED|90.0|4.48|9.48|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.48|4.48|<0.001
91711600|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.41||||0.003|TWO_SIDED|90.0|2.11|6.72|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.72|2.11|0.003
91711601|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.02|||<|0.001|TWO_SIDED|90.0|2.72|7.33|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.33|2.72|<0.001
91711602|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.58|||<|0.001|TWO_SIDED|90.0|4.27|8.88|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.88|4.27|<0.001
91711603|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|||<|0.001|TWO_SIDED|90.0|3.31|7.78|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.78|3.31|<0.001
91711604|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.44||||0.003|TWO_SIDED|90.0|2.06|6.82|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.82|2.06|0.003
91711605|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.7|9.47|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.47|4.70|<0.001
91711606|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.41||||0.103|TWO_SIDED|90.0|-0.02|4.84|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.84|-0.02|0.103
91614588|NCT00637273|183123285|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
91711607|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.013|TWO_SIDED|90.0|1.32|6.18|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.18|1.32|0.013
91614589|NCT00637273|183123285|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0120
91711608|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.96|||<|0.001|TWO_SIDED|90.0|3.53|8.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.39|3.53|<0.001
91711609|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.87|||<|0.001|TWO_SIDED|90.0|3.5|8.23|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.23|3.50|<0.001
91614590|NCT00637273|183123286|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.1700
91614591|NCT00637273|183123286|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0091
91711610|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.65|||<|0.001|TWO_SIDED|90.0|3.18|8.11|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.18|<0.001
91614592|NCT00637273|183123287|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.416||0.0002|TWO_SIDED|95.0|0.72|2.35||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.35|0.72|0.0002
91711611|NCT00572455|183314667|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.97|||<|0.001|TWO_SIDED|90.0|3.46|8.48|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.48|3.46|<0.001
91711612|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.72||||0.377|TWO_SIDED|90.0|-0.63|2.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.08|-0.63|0.377
91614593|NCT00637273|183123287|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.415|<|0.0001|TWO_SIDED|95.0|4.28|5.91||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.91|4.28|<.0001
91614594|NCT00637273|183123288|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|15.5|STANDARD_ERROR_OF_MEAN|4.95||0.0038|TWO_SIDED|95.0|5.7|25.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||25.2|5.7|0.0038
91614595|NCT00637273|183123288|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|4.98||0.3729|TWO_SIDED|95.0|-5.3|14.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||14.2|-5.3|0.3729
91614596|NCT00637273|183123289|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.26||0.0055|TWO_SIDED|95.0|1.3|6.3||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||6.3|1.3|0.0055
91614597|NCT00637273|183123289|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.25||0.1117|TWO_SIDED|95.0|-0.5|4.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||4.5|-0.5|0.1117
91614598|NCT00637273|183123290|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-0.4|2.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.5|-0.4|0.1685
91614599|NCT00637273|183123290|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-2.6|0.4||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.4|-2.6|0.1685
91614600|NCT00637273|183123291|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|3.31||0.2686|TWO_SIDED|95.0|-2.8|10.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||10.2|-2.8|0.2686
91614601|NCT00637273|183123291|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|3.3||0.0814|TWO_SIDED|95.0|0.3|13.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||13.2|0.3|0.0814
91655740|NCT03292653|183204346|SUPERIORITY||Difference in LS Means|847.2|STANDARD_ERROR_OF_MEAN|576.98||0.1761|TWO_SIDED|90.0|-210.46|1904.86|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1904.86|-210.46|0.1761
91655741|NCT03292653|183204346|SUPERIORITY||Difference in LS Means|489.33|STANDARD_ERROR_OF_MEAN|579.35||0.4202|TWO_SIDED|90.0|-572.68|1551.34|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1551.34|-572.68|0.4202
91655742|NCT03292653|183204347|SUPERIORITY||Difference in LS Means|13.75|STANDARD_ERROR_OF_MEAN|8.53||0.1242|TWO_SIDED|90.0|-1.03|28.53|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||28.53|-1.03|0.1242
91655743|NCT03292653|183204347|SUPERIORITY||Difference in LS Means|0.1|STANDARD_ERROR_OF_MEAN|7.73||0.9903|TWO_SIDED|90.0|-13.49|13.3|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||13.30|-13.49|0.9903
91655744|NCT03292653|183204348|SUPERIORITY||Difference in LS Means|-150.89|STANDARD_ERROR_OF_MEAN|116.09||0.2121|TWO_SIDED|90.0|-353.57|51.78|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||51.78|-353.57|0.2121
91711613|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.68||||0.039|TWO_SIDED|90.0|-3.01|-0.35|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||-0.35|-3.01|0.039
91711614|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34||||0.668|TWO_SIDED|90.0|-1.67|0.98|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.98|-1.67|0.668
91711615|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.121|TWO_SIDED|90.0|-0.07|2.59|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|-0.07|0.121
91711616|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.67||||0.039|TWO_SIDED|90.0|0.34|2.99|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.99|0.34|0.039
91614602|NCT00637273|183123292|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9546|TWO_SIDED|95.0|-1.6|1.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.5|-1.6|0.9546
91614603|NCT00637273|183123292|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|2.6|5.7||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.7|2.6|<.0001
91614604|NCT00637273|183123293|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04||0.9718|TWO_SIDED|95.0|0.93|1.08||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.08|0.93|0.9718
91614605|NCT00637273|183123293|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.035||0.0062|TWO_SIDED|95.0|0.82|0.96||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.96|0.82|0.0062
91614606|NCT02853331|183123295|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.00012|TWO_SIDED|95.0|0.56|0.84|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.84|0.56|0.00012
91614607|NCT02853331|183123296|SUPERIORITY||Hazard Ratio (HR)|0.53||||5e-05|TWO_SIDED|95.0|0.38|0.74|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.74|0.38|0.00005
91614608|NCT02853331|183123297|SUPERIORITY||Difference in percentages|23.6|||<|0.0001|TWO_SIDED|95.0|17.2|29.9|||Miettinen & Nurminen method|H0: difference in %=0 versus H1: difference in % \>0|Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||29.9|17.2|<0.0001
91614609|NCT02853331|183123298|SUPERIORITY||Difference in percentages|11.0|||||TWO_SIDED|95.0|4.8|17.0|||||Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||17.0|4.8|
91614610|NCT00844428|183123312|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
91614611|NCT00844428|183123313|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
91614612|NCT00844428|183123314|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
91614613|NCT00844428|183123315|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
91614614|NCT00844428|183123316|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
91711617|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99||||0.22|TWO_SIDED|90.0|-0.34|2.31|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.31|-0.34|0.220
91711618|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3||||0.098|TWO_SIDED|90.0|0.01|2.59|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|0.01|0.098
91655745|NCT03292653|183204348|SUPERIORITY||Difference in LS Means|-5.26|STANDARD_ERROR_OF_MEAN|96.88||0.9574|TWO_SIDED|90.0|-174.4|163.87|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||163.87|-174.4|0.9574
91655746|NCT02606500|183204360|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
91655747|NCT02606500|183204361|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.5|||||||Regression, Logistic|||||||0.5
91655748|NCT02606500|183204362|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.3|||||||Regression, Logistic|||||||0.3
91655749|NCT02606500|183204363|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
91655750|NCT02606500|183204364|NON_INFERIORITY|We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.||||||0.4|||||||Regression, Logistic|||||||0.4
91655751|NCT02465567|183204421|SUPERIORITY||Rate Ratio|0.76|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
91655752|NCT02465567|183204421|SUPERIORITY||Rate Ratio|0.87||||0.0027|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0027
91655753|NCT02465567|183204421|SUPERIORITY||Rate Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
91655754|NCT02465567|183204421|SUPERIORITY||Rate Ratio|0.86||||0.002|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0020
91655755|NCT02465567|183204422|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0035|TWO_SIDED|95.0|0.807|0.959|||Regression, Cox|||||0.959|0.807|0.0035
91655756|NCT02465567|183204422|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.057|TWO_SIDED|95.0|0.814|0.966|||Regression, Cox|||||0.966|0.814|0.057
91655757|NCT02465567|183204422|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.0011|TWO_SIDED|95.0|0.794|0.944|||Regression, Cox|||||0.944|0.794|0.0011
91711619|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.519|TWO_SIDED|90.0|-0.77|1.77|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-0.77|0.519
91655758|NCT02465567|183204422|SUPERIORITY||Hazard Ratio (HR)|0.873||||0.0019|TWO_SIDED|95.0|0.801|0.951|||Regression, Cox|||||0.951|0.801|0.0019
91655759|NCT02465567|183204423|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.34|||Linear Repeated Measures|||||-0.34|-0.68|<0.0001
91655760|NCT02465567|183204423|SUPERIORITY||Mean Difference (Final Values)|-0.37|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.2|||Linear Repeated Measures|||||-0.20|-0.54|<0.0001
91711620|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.724|TWO_SIDED|90.0|-1.0|1.55|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.55|-1.00|0.724
91655761|NCT02465567|183204423|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.53|-0.18|||Linear Repeated Measures|||||-0.18|-0.53|<0.0001
91711621|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.46||||0.059|TWO_SIDED|90.0|0.19|2.74|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.74|0.19|0.059
91655762|NCT02465567|183204423|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.0127|TWO_SIDED|95.0|-0.39|-0.05|||Linear Repeated Measures|||||-0.05|-0.39|0.0127
91655763|NCT02465567|183204424|SUPERIORITY||Odds Ratio (OR)|1.358|||<|0.0001|TWO_SIDED|95.0|1.199|1.539|||Regression, Logistic|||||1.539|1.199|<0.0001
91655764|NCT02465567|183204424|SUPERIORITY||Odds Ratio (OR)|1.246||||0.0005|TWO_SIDED|95.0|1.1|1.41|||Regression, Logistic|||||1.410|1.100|0.0005
91655765|NCT02465567|183204424|SUPERIORITY||Odds Ratio (OR)|1.283|||<|0.0004|TWO_SIDED|95.0|1.133|1.454|||Regression, Logistic|||||1.454|1.133|<0.0004
91655766|NCT02465567|183204424|SUPERIORITY||Odds Ratio (OR)|1.177||||0.0103|TWO_SIDED|95.0|1.039|1.333|||Regression, Logistic|||||1.333|1.039|0.0103
91655767|NCT02465567|183204425|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0111|TWO_SIDED|95.0|0.34|0.87|||Regression, Cox|||||0.870|0.340|0.0111
91655768|NCT02465567|183204425|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.3401|TWO_SIDED|95.0|0.472|1.296|||Regression, Cox|||||1.296|0.472|0.3401
91655769|NCT02465567|183204425|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.269|TWO_SIDED|95.0|0.518|1.201|||Regression, Cox|||||1.201|0.518|0.2690
91655770|NCT02465567|183204425|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.5918|TWO_SIDED|95.0|0.716|1.796|||Regression, Cox|||||1.796|0.716|0.5918
91655771|NCT02465567|183204426|SUPERIORITY||Rate Ratio|0.84||||0.6552|TWO_SIDED|95.0|0.69|1.03|||Negative Binomial Regression|||||1.03|0.69|0.6552
91655772|NCT02465567|183204426|SUPERIORITY||Rate Ratio|0.8||||0.0221|TWO_SIDED|95.0|0.66|0.97|||Negative Binomial Regression|||||0.97|0.66|0.0221
91655773|NCT02465567|183204426|SUPERIORITY||Rate Ratio|0.88||||0.2157|TWO_SIDED|95.0|0.72|1.08|||Negative Binomial Regression|||||1.08|0.72|0.2157
91655774|NCT02465567|183204426|SUPERIORITY||Rate Ratio|0.83||||0.0647|TWO_SIDED|95.0|0.69|1.01|||Negative Binomial Regression|||||1.01|0.69|0.0647
91655775|NCT01807637|183204434|SUPERIORITY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|5.37||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||.05
91655776|NCT01807637|183204435|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|1.12||0.05|TWO_SIDED||||||ANOVA|||||||.05
91655777|NCT01807637|183204436|SUPERIORITY||Mean Difference (Final Values)|15.67|STANDARD_DEVIATION|3.41||0.05|TWO_SIDED||||||ANOVA|||||||.05
91655778|NCT00662129|183204493|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91655779|NCT00329602|183204525|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Week 12.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.039
91655780|NCT00329602|183204525|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for Week 26.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.023
91655781|NCT02579096|183204540|NON_INFERIORITY|A non-inferiority bound of 8% was established during the trial design; a one-sided alpha level was set at 0.05.|Risk Difference (RD)|-7.0|||<|0.001|ONE_SIDED|95.0||-1.2|||t-test, 1 sided|||One-sided null hypothesis posited that allopurinol was inferior to febuxostat. The proportions of participants with ≥ 1 gout flare during phase 3 were compared between the two treatments.||-1.2||<0.001
91655782|NCT02097121|183204581|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.107|=|0.3802|TWO_SIDED|95.0|-3.203|1.243|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||1.243|-3.203|= 0.3802
91655783|NCT02097121|183204581|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.154|=|0.733|TWO_SIDED|95.0|-1.921|2.712|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||2.712|-1.921|= 0.733
91655784|NCT02097121|183204582|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.442|=|0.5743|TWO_SIDED|95.0|-2.082|3.713|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||3.713|-2.082|= 0.5743
91655785|NCT02097121|183204582|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.455|=|0.1451|TWO_SIDED|95.0|-0.769|5.078|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||5.078|-0.769|= 0.1451
91655786|NCT02097121|183204583|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.434|=|0.8206|TWO_SIDED|95.0|-3.205|2.551|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.551|-3.205|= 0.8206
91655787|NCT02097121|183204583|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|1.434|=|0.9604|TWO_SIDED|95.0|-2.807|2.95|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.95|-2.807|= 0.9604
91655788|NCT02097121|183204585|SUPERIORITY||LS Mean Difference|35.33|STANDARD_ERROR_OF_MEAN|22.175|=|0.1174|TWO_SIDED|95.0|-9.207|79.873|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||79.873|-9.207|= 0.1174
91655789|NCT02097121|183204585|SUPERIORITY||LS Mean Difference|34.11|STANDARD_ERROR_OF_MEAN|23.722|=|0.1567|TWO_SIDED|95.0|-13.536|81.76|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||81.76|-13.536|= 0.1567
91655790|NCT02097121|183204586|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|4.091|=|0.7481|TWO_SIDED|95.0|-9.553|6.909|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||6.909|-9.553|= 0.7481
91691891|NCT02667704|183278334|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|101.98|STANDARD_DEVIATION|10.3|||TWO_SIDED|90.0|94.909|109.57|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||109.570|94.909|
91691892|NCT00997373|183278349|SUPERIORITY_OR_OTHER|||||||0.0373|TWO_SIDED||||||Fisher Exact|||||||0.0373
91691893|NCT00832455|183278362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
91691894|NCT00832455|183278362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
91655791|NCT02097121|183204586|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|4.299|=|0.6691|TWO_SIDED|95.0|-6.799|10.498|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||10.498|-6.799|= 0.6691
91655792|NCT02097121|183204587|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.343|=|0.9297|TWO_SIDED|95.0|-0.721|0.661|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.661|-0.721|= 0.9297
91655793|NCT02097121|183204587|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.357|=|0.3976|TWO_SIDED|95.0|-1.022|0.413|||ANCOVA|||Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.||0.413|-1.022|= 0.3976
91655794|NCT02097121|183204588|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.302|=|0.3309|TWO_SIDED|95.0|-0.311|0.904|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.904|-0.311|= 0.3309
91655795|NCT02097121|183204588|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.315|=|0.2235|TWO_SIDED|95.0|-0.245|1.024|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||1.024|-0.245|= 0.2235
91655796|NCT02097121|183204589|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.274|=|0.6689|TWO_SIDED|95.0|-0.434|0.67|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.67|-0.434|= 0.6689
91655797|NCT02097121|183204589|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.288|=|0.6076|TWO_SIDED|95.0|-0.431|0.729|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.729|-0.431|= 0.6076
91655798|NCT02097121|183204590|SUPERIORITY||Risk difference %|15.5|||=|0.6092|TWO_SIDED|95.0|-18.94|46.19|||Cochran-Mantel-Haenszel|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||46.19|-18.94|= 0.6092
91655799|NCT02097121|183204590|SUPERIORITY||Risk difference %|17.6|||=|0.4824|TWO_SIDED|95.0|-16.2|48.9|||Cochran-Mantel-Haenszel|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||48.9|-16.2|= 0.4824
91655800|NCT01200394|183204621|SUPERIORITY||Geometric Mean Ratio|0.843||||0.9889|TWO_SIDED|95.0|0.728|0.975||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.|ANCOVA||Geometric mean ratio and corresponding 95% credible intervals were calculated.|Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||0.975|0.728|0.9889
91691895|NCT00832455|183278364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.||||||<0.001
91691896|NCT00832455|183278364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.||||||<0.001
91691897|NCT00832455|183278365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.||||||<0.001
91691898|NCT00832455|183278366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|Change in PACQLQ score between Week 12 and baseline is statistically different than zero||||||<0.001
91691899|NCT02883062|183278430|SUPERIORITY|||||||0.36|||||||Generalized estimating equation (GEE)|||||||0.36
91691900|NCT02883062|183278431|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||||||0.018
91614615|NCT00844428|183123317|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
91614616|NCT00844428|183123318|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
91614617|NCT00844428|183123319|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
91614618|NCT00844428|183123320|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
91614619|NCT00844428|183123321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
91614620|NCT00844428|183123322|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
91614621|NCT00844428|183123323|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
91614622|NCT00064662|183123378|SUPERIORITY_OR_OTHER||Other|0.0||||0.01||95.0|||||Log Rank|||Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.||||0.01
91614623|NCT00064662|183123379|SUPERIORITY_OR_OTHER||Chi-square|16.2|||<|0.001||95.0|||||Log Rank|||Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.||||<0.001
91711622|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.71|||<|0.001|TWO_SIDED|90.0|1.43|3.98|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.98|1.43|<0.001
91711623|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.008|TWO_SIDED|90.0|0.82|3.37|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.37|0.82|0.008
91614624|NCT00064662|183123379|SUPERIORITY_OR_OTHER||Other|0.0|||<|0.0001||95.0|||||Kalpan Meier (Wald statistic)|||Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.||||<0.0001
91614625|NCT03008590|183123380|SUPERIORITY|||||||0.9||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.90
91614626|NCT03008590|183123381|SUPERIORITY|||||||0.22||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.22
91614627|NCT03008590|183123382|SUPERIORITY|||||||0.02||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.02
91614628|NCT03008590|183123383|SUPERIORITY|||||||0.3||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.3
91614629|NCT03008590|183123384|SUPERIORITY|||||||0.04||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.04
91614630|NCT03008590|183123385|SUPERIORITY|||||||0.78||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.78
91614631|NCT03008590|183123386|SUPERIORITY|||||||0.92||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.92
91614632|NCT01555463|183123391|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|center-adjusted||||||<.001
91614633|NCT01555463|183123392|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|F-test for treatment effect of the ANCOVA model with treatment group and study center as the factors and baseline lesion count as the covariate.||||||<.001
91711624|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.32||||0.068|TWO_SIDED|90.0|0.13|2.51|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.51|0.13|0.068
91711625|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.994|TWO_SIDED|90.0|-1.16|1.18|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.18|-1.16|0.994
91524271|NCT04022889|182923716|OTHER|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|10.2|||TWO_SIDED|95.0|-5.0|8.7|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||8.7|-5.0|
91614634|NCT04436510|183123409|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.118|||TWO_SIDED|95.0|0.769|1.237||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. verdiperstat slowed progression) was 0.57467. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.237|0.769|
91614635|NCT04436510|183123411|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|2.054||0.8875|TWO_SIDED|95.0|-3.74|4.32|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||4.32|-3.74|0.8875
91614636|NCT04436510|183123412|SUPERIORITY||Mean Difference (Net)|3.57|STANDARD_ERROR_OF_MEAN|3.848||0.3538|TWO_SIDED|95.0|-3.99|11.13|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||11.13|-3.99|0.3538
91614637|NCT04436510|183123413|SUPERIORITY|||||||0.318|||||||Log Rank|||||||0.318
91614638|NCT05137041|183123449|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91614639|NCT05137041|183123451|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.015|TWO_SIDED|95.0|-0.817|-0.137|||ANCOVA|The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).||||-0.137|-0.817|0.015
91614640|NCT05137041|183123452|SUPERIORITY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.47||0.103|TWO_SIDED|95.0|-32.661|0.828||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.828|-32.661|0.103
91711626|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.494|TWO_SIDED|90.0|-0.7|1.69|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-0.70|0.494
91711627|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.39||||0.063|TWO_SIDED|90.0|0.16|2.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.62|0.16|0.063
91614641|NCT05137041|183123453|SUPERIORITY||Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|0.511|1.581||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||1.581|0.511|<0.001
91614642|NCT05137041|183123454|SUPERIORITY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.121|TWO_SIDED|95.0|-2.976|0.25||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.250|-2.976|0.121
91614643|NCT05137041|183123455|SUPERIORITY|||||||0.564||||||The p-value is adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|Log Rank|||||||0.564
91614644|NCT05137041|183123456|SUPERIORITY|||||||0.289|||||||Log Rank|||||||0.289
91614645|NCT05137041|183123457|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 1 Evening||||0.001
91614646|NCT05137041|183123457|SUPERIORITY|||||||0.035|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Morning||||0.035
91614647|NCT05137041|183123457|SUPERIORITY|||||||0.004|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Evening||||0.004
91614648|NCT05137041|183123457|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Morning||||0.007
91614649|NCT05137041|183123457|SUPERIORITY|||||||0.005|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Evening||||0.005
91614650|NCT05137041|183123457|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Morning||||0.001
91614651|NCT05137041|183123457|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Evening||||0.007
91614652|NCT05137041|183123457|SUPERIORITY|||||||0.096|||||||Satterthwaite t-test|||Change from Baseline at Day 5 Morning||||0.096
91614653|NCT05137041|183123457|SUPERIORITY|||||||0.015|||||||Satterthwaite t-test|||Change from Baseline at Day 5||||0.015
91614654|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 1 Evening||||<0.001
91614655|NCT05137041|183123458|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||VRS: Day 2 Morning||||0.001
91614656|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 2 Evening||||<0.001
91614657|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Morning||||<0.001
91614658|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Evening||||<0.001
91614659|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Morning||||<0.001
91614660|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Evening||||<0.001
91614661|NCT05137041|183123458|SUPERIORITY|||||||0.024|||||||Satterthwaite t-test|||VRS: Day 5 Morning||||0.024
91614662|NCT05137041|183123458|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 5||||<0.001
91614663|NCT05137041|183123459|SUPERIORITY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.415|0.903|||ANCOVA|||||0.903|0.415|<0.001
91711628|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.15||||0.004|TWO_SIDED|90.0|0.95|3.34|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.34|0.95|0.004
91711629|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.17||||0.004|TWO_SIDED|90.0|0.97|3.38|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.97|0.004
91711630|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.55||||0.038|TWO_SIDED|90.0|0.32|2.77|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.32|0.038
91711631|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.48||||0.512|TWO_SIDED|90.0|-0.72|1.68|||ANCOVA|||Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.68|-0.72|0.512
91711632|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.66||||0.373|TWO_SIDED|90.0|-0.56|1.89|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.89|-0.56|0.373
91711633|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.088|TWO_SIDED|90.0|0.05|2.56|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.56|0.05|0.088
91711634|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21||||0.004|TWO_SIDED|90.0|0.98|3.44|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.98|0.004
91711635|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.33||||0.003|TWO_SIDED|90.0|1.09|3.57|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.57|1.09|0.003
91614664|NCT02433210|183123460|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobilin Optiflux vs Revaclear.||||<0.001
91614665|NCT02433210|183123460|SUPERIORITY||||||<|0.001||||||The p value is not adjusted for multiple comparisons and a p\<0.05 is considered significant.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
91711636|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.87||||0.01|TWO_SIDED|90.0|0.69|3.04|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.04|0.69|0.010
91711637|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.89||||0.205|TWO_SIDED|90.0|-0.27|2.05|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.05|-0.27|0.205
91614666|NCT02433210|183123460|SUPERIORITY||||||=|0.178||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobulin Revaclear vs ELISIO..||||=0.178
91614667|NCT02433210|183123460|SUPERIORITY||||||=|0.016||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs Revaclear.||||=0.016
91614668|NCT02433210|183123460|SUPERIORITY||||||=|0.033||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs ELISIO.||||=0.033
91711638|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.44||||0.045|TWO_SIDED|90.0|0.26|2.63|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.63|0.26|0.045
91711639|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.005|TWO_SIDED|90.0|0.88|3.31|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.31|0.88|0.005
91711640|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.51|||<|0.001|TWO_SIDED|90.0|1.33|3.7|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.70|1.33|<0.001
91711641|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.002|TWO_SIDED|90.0|1.1|3.48|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.48|1.10|0.002
91711642|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.757|TWO_SIDED|90.0|-1.15|1.69|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-1.15|0.757
91614669|NCT02433210|183123460|SUPERIORITY||||||=|0.935|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Revaclear vs ELISIO.||||=0.935
91614670|NCT02433210|183123460|SUPERIORITY||||||=|0.463|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs Revaclaer.||||=0.463
91614671|NCT02433210|183123460|SUPERIORITY||||||=|0.392|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.392
91614672|NCT02433210|183123460|SUPERIORITY||||||=|0.597|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance urea nitrogen Revaclear vs ELISIO.||||=0.597
91614673|NCT02433210|183123460|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs Revaclear.||||=0.162
91614674|NCT02433210|183123460|SUPERIORITY|||||||0.186|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs ELISIO.||||0.186
91614675|NCT02433210|183123460|SUPERIORITY|No Significant difference.||||||0.624|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs Revaclear.||||0.624
91614676|NCT02433210|183123460|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs ELISIO.||||0.732
91614677|NCT02433210|183123460|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea Nitrogen clearance Revaclear vs Optiflux.||||0.427
91655801|NCT01200394|183204621|SUPERIORITY|||||||0.2402|TWO_SIDED|||||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.|ANCOVA|||ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||||0.2402
91614678|NCT02433210|183123460|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs Revaclear..||||0.379
91614679|NCT02433210|183123460|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs ELISIO.||||0.318
91614680|NCT02433210|183123460|SUPERIORITY||||||=|0.914|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Revaclear vs ELISIO.||||=0.914
91614681|NCT02433210|183123460|SUPERIORITY||||||=|0.623|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs Revaclear.||||=0.623
91614682|NCT02433210|183123460|SUPERIORITY||||||=|0.403|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs ELISIO.||||=0.403
91614683|NCT02433210|183123460|SUPERIORITY||||||=|0.85|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Revaclear vs ELISIO.||||=0.850
91614684|NCT02433210|183123460|SUPERIORITY||||||=|0.815|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Revaclear vs ELISIO.||||=0.815
91614685|NCT02433210|183123460|SUPERIORITY||||||=|0.367|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of Phosphate Optiflux vs Revaclear.||||=0.367
91614686|NCT02433210|183123460|SUPERIORITY||||||=|0.821|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of phosphate Optiflux vs Elisio.||||=0.821
91614687|NCT02433210|183123460|SUPERIORITY||||||=|0.364|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance phosphate Revaclear vs ELISIO.||||=0.364
91614688|NCT02433210|183123460|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
91614689|NCT02433210|183123460|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
91614690|NCT02433210|183123460|SUPERIORITY||||||=|0.254|||||||t-test, 2 sided|||Session 2 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.254
91614691|NCT02433210|183123460|SUPERIORITY||||||=|0.079|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs Revaclear.||||=0.079
91614692|NCT02433210|183123460|SUPERIORITY||||||=|0.086|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs ELISIO.||||=0.086
91711643|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.878|TWO_SIDED|90.0|-1.54|1.27|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.27|-1.54|0.878
91711644|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.78|TWO_SIDED|90.0|-1.64|1.17|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.17|-1.64|0.780
91614693|NCT02433210|183123460|SUPERIORITY||||||=|0.888|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance myoglobin Revaclear vs ELISIO.||||=0.888
91614694|NCT02433210|183123460|SUPERIORITY||||||=|0.663||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs Revaclear.||||=0.663
91614695|NCT02433210|183123460|SUPERIORITY||||||=|0.391|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.391
91614696|NCT02433210|183123460|SUPERIORITY||||||=|0.214|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Revaclear vs ELISIO.||||=0.214
91614697|NCT02433210|183123460|SUPERIORITY||||||=|0.918|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs Revaclear.||||=0.918
91614698|NCT02433210|183123460|SUPERIORITY||||||=|0.394|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs ELISIO.||||=0.394
91614699|NCT02433210|183123460|SUPERIORITY||||||=|0.211|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Revaclear vs ELISIO.||||=0.211
91614700|NCT02433210|183123460|SUPERIORITY||||||=|0.222|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of phosphate Optiflux vs ELISIO.||||=0.222
91614701|NCT02433210|183123460|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of phosphate Revaclear vs ELISIO.||||=0.162
91711645|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.67|TWO_SIDED|90.0|-1.04|1.77|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-1.04|0.670
91711646|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.98||||0.021|TWO_SIDED|90.0|0.58|3.38|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.58|0.021
91711647|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.126|TWO_SIDED|90.0|-0.1|2.71|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.71|-0.10|0.126
91614702|NCT02433210|183123460|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
91614703|NCT02433210|183123460|SUPERIORITY||||||=|0.025||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of beta 2 microglobulin Optiflux vs ELISIO.||||=0.025
91614704|NCT02433210|183123460|SUPERIORITY||||||=|0.903|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.903
91614705|NCT02433210|183123460|SUPERIORITY||||||=|0.003||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of myoglobin Optiflux vs Revaclear.||||=0.003
91614706|NCT02433210|183123460|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Optiflux vs ELISIO.||||<0.001
91614707|NCT02433210|183123460|SUPERIORITY||||||=|0.472|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Revaclear vs ELISIO.||||=0.472
91614708|NCT02433210|183123461|SUPERIORITY||||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
91614709|NCT02433210|183123461|SUPERIORITY|No significant difference|||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
91711648|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.215|TWO_SIDED|90.0|-0.32|2.26|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.26|-0.32|0.215
91711649|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37||||0.635|TWO_SIDED|90.0|-1.65|0.91|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.91|-1.65|0.635
91614710|NCT02433210|183123461|SUPERIORITY|No significant difference|||||=|0.952||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.952
91614711|NCT02433210|183123461|SUPERIORITY|No Significant difference|||||=|0.714||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
91711650|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06||||0.934|TWO_SIDED|90.0|-1.35|1.22|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.35|0.934
91614712|NCT02433210|183123461|SUPERIORITY||||||=|0.156||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.156
91614713|NCT02433210|183123461|SUPERIORITY||||||=|0.427||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.427
91614714|NCT02433210|183123461|SUPERIORITY||||||=|0.487||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.487
91614715|NCT02433210|183123461|SUPERIORITY|Failed normality test|||||=|0.111||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|The difference in the median values between the two groups is not \> enough to exclude that the difference is due to random sampling variability||No significant difference||||=0.111
91614716|NCT02433210|183123461|SUPERIORITY|Failed normality test|||||=|0.198||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.198
91614717|NCT02433210|183123461|SUPERIORITY||||||=|0.007||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Showed a significant difference||||=0.007
91614718|NCT02433210|183123461|SUPERIORITY||||||=|0.202||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.202
91614719|NCT02433210|183123461|SUPERIORITY||||||=|0.54||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.540
91614720|NCT02433210|183123462|SUPERIORITY||||||=|0.204|||||||Wilcoxon (Mann-Whitney)|||||||=0.204
91614721|NCT02433210|183123462|SUPERIORITY||||||=|0.234|||||||Wilcoxon (Mann-Whitney)|||||||=0.234
91614722|NCT02433210|183123462|SUPERIORITY||||||=|0.015||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the \<0.050 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either then the non-parametric Mann-Whitney Rank Sum Test was used.||||||=0.015
91614723|NCT02433210|183123462|SUPERIORITY||||||=|0.413||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.413
91614724|NCT02433210|183123462|SUPERIORITY||||||=|0.314||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.314
91614725|NCT02433210|183123462|SUPERIORITY||||||=|0.769||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.769
91614726|NCT02433210|183123463|SUPERIORITY||||||=|0.376|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.376
91614727|NCT02433210|183123463|SUPERIORITY|||||||1||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||1.000
91614728|NCT02433210|183123463|SUPERIORITY|||||||0.713|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||0.713
91711651|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56||||0.478|TWO_SIDED|90.0|-0.74|1.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.87|-0.74|0.478
91711652|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.57||||0.002|TWO_SIDED|90.0|1.26|3.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.87|1.26|0.002
91614729|NCT02433210|183123463|SUPERIORITY||||||=|0.424|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.424
91614730|NCT02433210|183123463|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.230
91614731|NCT02433210|183123463|SUPERIORITY||||||=|0.678|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.678
91614732|NCT02433210|183123463|SUPERIORITY||||||=|0.643|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.643
91614733|NCT02433210|183123463|SUPERIORITY||||||=|0.43|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.430
91614734|NCT02433210|183123463|SUPERIORITY||||||=|0.295|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.295
91614735|NCT02433210|183123463|SUPERIORITY||||||=|0.723|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.723
91614736|NCT02433210|183123463|SUPERIORITY||||||=|0.749|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.749
91614737|NCT02433210|183123463|SUPERIORITY||||||=|0.967|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.967
91614738|NCT02433210|183123464|SUPERIORITY||||||=|0.67|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.670
91614739|NCT02433210|183123464|SUPERIORITY||||||=|0.993|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.993
91614740|NCT02433210|183123464|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.650
91614741|NCT02433210|183123464|SUPERIORITY||||||=|0.299|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.299
91614742|NCT02433210|183123464|SUPERIORITY||||||=|0.659|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.659
91614743|NCT02433210|183123464|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
91614744|NCT02433210|183123464|SUPERIORITY||||||=|0.853|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.853
91614745|NCT02433210|183123464|SUPERIORITY||||||=|0.494|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.494
91614746|NCT02433210|183123464|SUPERIORITY||||||=|0.631|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.631
91614747|NCT02433210|183123464|SUPERIORITY||||||=|0.37|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.370
91614748|NCT02433210|183123464|SUPERIORITY||||||=|0.95|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.950
91614749|NCT02433210|183123464|SUPERIORITY||||||=|0.377|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.377
91614750|NCT02433210|183123465|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
91614751|NCT02433210|183123465|SUPERIORITY||||||=|0.578|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.578
91614752|NCT02433210|183123465|SUPERIORITY||||||=|0.225|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.225
91614753|NCT02433210|183123465|SUPERIORITY||||||=|0.125|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.125
91614754|NCT02433210|183123465|SUPERIORITY||||||=|0.466|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.466
91614755|NCT02433210|183123465|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
91614756|NCT02433210|183123465|SUPERIORITY||||||=|0.584|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.584
91711653|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.013|TWO_SIDED|90.0|0.68|3.3|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.30|0.68|0.013
91614757|NCT02433210|183123465|SUPERIORITY||||||=|0.981|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.981
91711654|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.736|TWO_SIDED|90.0|-1.04|1.57|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.57|-1.04|0.736
91711655|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68||||0.386|TWO_SIDED|90.0|-1.96|0.61|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.61|-1.96|0.386
91614758|NCT02433210|183123465|SUPERIORITY||||||=|0.568|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.568
91614759|NCT02433210|183123465|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.240
91614760|NCT02433210|183123465|SUPERIORITY||||||=|0.724|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.724
91614761|NCT02433210|183123465|SUPERIORITY||||||=|0.445|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.445
91614762|NCT02433210|183123466|SUPERIORITY||||||=|0.114|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.114
91614763|NCT02433210|183123466|SUPERIORITY||||||=|0.292|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.292
91614764|NCT02433210|183123466|SUPERIORITY||||||=|0.714|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
91655802|NCT01200394|183204622|SUPERIORITY||Geometric Mean Ratio|0.8759||||0.0382|TWO_SIDED|95.0|0.7727|0.9927|||Mixed Models Analysis|||Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9927|0.7727|0.0382
91655803|NCT01200394|183204622|SUPERIORITY||Geometric Mean Ratio|0.8311||||0.0112|TWO_SIDED|95.0|0.7208|0.9584|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9584|0.7208|0.0112
91711656|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.948|TWO_SIDED|90.0|-1.35|1.24|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.24|-1.35|0.948
91711657|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.908|TWO_SIDED|90.0|-1.41|1.22|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.41|0.908
91614765|NCT02433210|183123466|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
91614766|NCT02433210|183123466|SUPERIORITY||||||=|0.19|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.190
91614767|NCT02433210|183123466|SUPERIORITY|||||||-0.009|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||-0.009
91614768|NCT02433210|183123466|SUPERIORITY||||||=|0.911|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.911
91614769|NCT02433210|183123466|SUPERIORITY||||||=|0.388|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.388
91614770|NCT02433210|183123466|SUPERIORITY||||||=|0.337|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.337
91614771|NCT02433210|183123466|SUPERIORITY||||||=|0.575|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.575
91614772|NCT02433210|183123466|SUPERIORITY||||||=|0.88|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.880
91614773|NCT02433210|183123466|SUPERIORITY||||||=|0.731|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.731
91614774|NCT00051558|183123499|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
91614775|NCT00051558|183123500|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
91711658|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97||||0.015|TWO_SIDED|90.0|0.65|3.28|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.28|0.65|0.015
91614776|NCT00051558|183123501|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||P-value for Month 3|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.058
91614777|NCT00051558|183123501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614778|NCT00051558|183123501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614779|NCT00051558|183123501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614780|NCT00051558|183123501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614781|NCT00051558|183123501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614782|NCT00051558|183123502|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value for 3 Months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.120
91614783|NCT00051558|183123502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614784|NCT00051558|183123502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91791327|NCT01816451|183460322|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post training data were expressed as mean and standard deviation. HR and \[La\], were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables RPE, Velocity were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used. Control didn't do submaximal test for training intensities.||||<0.05
91614785|NCT00051558|183123502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614786|NCT00051558|183123503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
91614787|NCT00051558|183123503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614788|NCT00051558|183123503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614789|NCT00051558|183123504|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36-month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||<0.001
91614790|NCT00051558|183123504|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614791|NCT00051558|183123504|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
91711659|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.046|TWO_SIDED|90.0|0.29|2.92|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.92|0.29|0.046
91711660|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.042|TWO_SIDED|90.0|0.31|2.89|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.89|0.31|0.042
91711661|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06||||0.94|TWO_SIDED|90.0|-1.22|1.34|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.34|-1.22|0.940
91711662|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.24||||0.114|TWO_SIDED|90.0|-0.05|2.53|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.53|-0.05|0.114
91711663|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.228|TWO_SIDED|90.0|-0.35|2.28|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.28|-0.35|0.228
91614792|NCT00051558|183123504|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||0.011
91614793|NCT00051558|183123504|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
91614794|NCT00051558|183123505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||<0.001
91614795|NCT00051558|183123505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614796|NCT00051558|183123505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614797|NCT00051558|183123505|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||0.006
91711664|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.005|TWO_SIDED|90.0|0.98|3.6|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.60|0.98|0.005
91711665|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.063|TWO_SIDED|90.0|0.17|2.79|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.79|0.17|0.063
91711666|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.562|TWO_SIDED|90.0|-0.92|1.91|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.91|-0.92|0.562
91711667|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.67||||0.431|TWO_SIDED|90.0|-0.73|2.07|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.07|-0.73|0.431
91711668|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.795|TWO_SIDED|90.0|-1.18|1.62|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-1.18|0.795
91614798|NCT00051558|183123505|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
91614799|NCT00051558|183123506|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614800|NCT00051558|183123506|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
91614801|NCT00051558|183123506|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
91655804|NCT01200394|183204622|SUPERIORITY||Geometric Mean Ratio|0.8816||||0.149|TWO_SIDED|95.0|0.7427|1.0465|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0465|0.7427|0.1490
91655805|NCT01200394|183204623|SUPERIORITY||Geometric Mean Ratio|0.8565||||0.0297|TWO_SIDED|95.0|0.745|0.9847|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9847|0.7450|0.0297
91655806|NCT01200394|183204623|SUPERIORITY||Geometric Mean Ratio|0.8524||||0.0305|TWO_SIDED|95.0|0.7376|0.985|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9850|0.7376|0.0305
91655807|NCT01200394|183204623|SUPERIORITY||Geometric Mean Ratio|0.7937||||0.0068|TWO_SIDED|95.0|0.6717|0.9378|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9378|0.6717|0.0068
91655808|NCT01200394|183204623|SUPERIORITY||Geometric Mean Ratio|0.8634||||0.1151|TWO_SIDED|95.0|0.719|1.0368|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0368|0.7190|0.1151
91655809|NCT01200394|183204624|SUPERIORITY||Geometric Mean Ratio|0.9816||||0.3585|TWO_SIDED|95.0|0.9434|1.0214|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0214|0.9434|0.3585
91655810|NCT01200394|183204624|SUPERIORITY||Geometric Mean Ratio|0.9939||||0.7475|TWO_SIDED|95.0|0.9577|1.0315|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0315|0.9577|0.7475
91655811|NCT01200394|183204624|SUPERIORITY||Geometric Mean Ratio|0.9866||||0.4972|TWO_SIDED|95.0|0.9488|1.0259|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0259|0.9488|0.4972
91655812|NCT01200394|183204624|SUPERIORITY||Geometric Mean Ratio|1.0024||||0.9146|TWO_SIDED|95.0|0.9588|1.0481|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0481|0.9588|0.9146
91655813|NCT01200394|183204625|SUPERIORITY||Least Squares (LS) Mean Difference|-5.39|STANDARD_ERROR_OF_MEAN|1.2942|<|0.0001|TWO_SIDED|95.0|-7.94|-2.84|||Mixed Models Analysis|||Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.84|-7.94|<0.0001
91655814|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|0.849|<|0.0001|TWO_SIDED|95.0|-5.38|-2.04|||Mixed Models Analysis|||Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.04|-5.38|<0.0001
91655815|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.9489|<|0.0001|TWO_SIDED|95.0|-6.46|-2.72|||Mixed Models Analysis|||Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.72|-6.46|<0.0001
91655816|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4056||0.7093|TWO_SIDED|95.0|-3.29|2.24|||Mixed Models Analysis|||Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.24|-3.29|0.7093
91655817|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.9089||0.6564|TWO_SIDED|95.0|-1.39|2.2|||Mixed Models Analysis|||Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.20|-1.39|0.6564
91711669|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.032|TWO_SIDED|90.0|0.43|3.23|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.23|0.43|0.032
91791328|NCT03445156|183460374|OTHER|ANCOVA||||||0.04|||||||ANCOVA|F(2, 273) = 3.16, p = .044, partial c\^2 = .023||||||0.04
91791329|NCT03445156|183460374|OTHER|ANCOVA||||||0.0001|||||||ANCOVA|F(1, 36) = 44.42||||||.0001
91711670|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.002|TWO_SIDED|90.0|1.34|4.13|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.13|1.34|0.002
91614802|NCT00051558|183123506|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614803|NCT00051558|183123507|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.011
91614804|NCT00051558|183123507|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
91614805|NCT00051558|183123507|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614806|NCT00051558|183123507|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
91614807|NCT00051558|183123508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614808|NCT00051558|183123508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614809|NCT00051558|183123508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614810|NCT00051558|183123508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614811|NCT00051558|183123509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614812|NCT00051558|183123509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614813|NCT00051558|183123509|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.004
91614814|NCT00051558|183123509|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.013
91614815|NCT00051558|183123510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614816|NCT00051558|183123510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614817|NCT00051558|183123510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614818|NCT00051558|183123510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614819|NCT00051558|183123511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614820|NCT00051558|183123511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614821|NCT00051558|183123511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614822|NCT00051558|183123511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614823|NCT00051558|183123512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614824|NCT00051558|183123512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614825|NCT00051558|183123512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614826|NCT00051558|183123512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
91614827|NCT00051558|183123513|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||p-value for Any Fracture|Cochran-Mantel-Haenszel|||||||0.212
91614828|NCT00051558|183123513|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||p-value for Nonvertebral Fracture|Cochran-Mantel-Haenszel|||||||0.843
91614829|NCT00051558|183123513|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value for Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.007
91614830|NCT00051558|183123513|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||p-value for Clinical Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.037
91614831|NCT00051558|183123513|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||p-value for Nonvertebral Fragility Fracture|Cochran-Mantel-Haenszel|||||||0.256
91614832|NCT02163993|183123519|SUPERIORITY||Posterior Mean Difference|-0.57|STANDARD_DEVIATION|0.42|||TWO_SIDED|95.0|-1.4|0.24|||Bayesian Dose Response Model|||||0.24|-1.40|
91614833|NCT02163993|183123519|SUPERIORITY||Posterior Mean Difference|-0.25|STANDARD_DEVIATION|0.41|||TWO_SIDED|95.0|-1.06|0.56|||Bayesian Dose Response Model|||||0.56|-1.06|
91614834|NCT02163993|183123519|SUPERIORITY||Posterior Mean Difference|-1.14|STANDARD_DEVIATION|0.44|||TWO_SIDED|95.0|-2.02|-0.29|||Bayesian Dose Response Model|||||-0.29|-2.02|
91711671|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.017|TWO_SIDED|90.0|0.64|3.44|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.64|0.017
91791330|NCT03445156|183460375|OTHER|ANCOVA|||||<|0.001|||||||ANCOVA|F(1, 36) = 44.42||Hypothesis: Participants who played a violent FPS game were expected to have more hits to targets with heads or faces than were participants who played a nonviolent shooting game.||||<.001
91614835|NCT02163993|183123519|SUPERIORITY||Posterior Mean Difference|-0.62|STANDARD_DEVIATION|0.45|||TWO_SIDED|95.0|-1.5|0.27|||Bayesian Dose Response Model|||||0.27|-1.50|
91614836|NCT01808118|183123532|OTHER||||||<|0.001||||||2-sided Pearson's chi-square test|Chi-squared|||||||<0.001
91614837|NCT01808118|183123551|OTHER||||||<|0.001|||||||Log Rank|||The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.||||<0.001
91614838|NCT02369835|183123566|OTHER|||||||0.8872|||||||Chi-squared|||||||.8872
91614839|NCT01984346|183123583|SUPERIORITY||Mean Difference (Net)|16.7||||0.0472|TWO_SIDED|95.0|0.1|33.2||A prior threshold for statistical significance was 0.05|Chi-square test|||||33.2|0.1|0.0472
91614840|NCT02042404|183123594|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
91614841|NCT02042404|183123595|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
91614842|NCT02042404|183123596|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
91614843|NCT02042404|183123597|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||repeated measures ANOVA|||||||0.0281
91614844|NCT03100942|183123599|SUPERIORITY||Difference in Response Rates|15.6||||0.1597|TWO_SIDED|95.0|-6.3|37.6||P-values were obtained from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||37.6|-6.3|0.1597
91614845|NCT03100942|183123599|SUPERIORITY||Difference in Response Rates|16.6||||0.1694|TWO_SIDED|95.0|-5.1|38.3||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||38.3|-5.1|0.1694
91614846|NCT03100942|183123599|SUPERIORITY||Difference in Response Rates|8.1||||0.3309|TWO_SIDED|95.0|-13.2|29.4||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||29.4|-13.2|0.3309
91614847|NCT03100942|183123600|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.05||0.2066|TWO_SIDED|95.0|-0.7|3.4|||MMRM|||Least Squares (LS) Means, 95% confidence interval (CI), and P-values were obtained from Mixed Effects Model for Repeated Measures (MMRM) with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||3.4|-0.7|0.2066
91614848|NCT03100942|183123600|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.04||0.3998|TWO_SIDED|95.0|-2.9|1.2|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.2|-2.9|0.3998
91614849|NCT03100942|183123600|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.04||0.5113|TWO_SIDED|95.0|-1.4|2.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.7|-1.4|0.5113
91614850|NCT03100942|183123601|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9446|TWO_SIDED|95.0|-0.9|1.0|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.0|-0.9|0.9446
91614851|NCT03100942|183123601|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3977|TWO_SIDED|95.0|-1.3|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.3|0.3977
91614852|NCT03100942|183123601|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4966|TWO_SIDED|95.0|-1.2|0.6|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.6|-1.2|0.4966
91614853|NCT03100942|183123602|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9564|TWO_SIDED|95.0|-2.2|2.1|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.1|-2.2|0.9564
91614854|NCT03100942|183123602|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.07||0.2788|TWO_SIDED|95.0|-3.3|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-3.3|0.2788
91614855|NCT03100942|183123602|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06||0.8047|TWO_SIDED|95.0|-1.8|2.3|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.3|-1.8|0.8047
91614856|NCT03100942|183123603|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6782|TWO_SIDED|95.0|-1.1|0.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.7|-1.1|0.6782
91614857|NCT03100942|183123603|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.9171|TWO_SIDED|95.0|-0.8|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-0.8|0.9171
91614858|NCT03100942|183123603|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.4641|TWO_SIDED|95.0|-1.2|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.2|0.4641
91614859|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.047||||||"P- value for social function"|Wilcoxon signed-rank test|||||||0.047
91614860|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.688||||||"P- value of  symptom/problem list "|Wilcoxon signed-rank test|||||||0.688
91614861|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.772||||||"P- value of  effects of kidney disease "|Wilcoxon signed-rank test|||||||0.772
91614862|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.301||||||"P-value of  burden of kidney disease "|Wilcoxon signed-rank test|||||||0.301
91614863|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.25||||||"P-value of  work status "|Wilcoxon signed-rank test|||||||0.250
91614864|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.895||||||"P-value of  cognitive function "|Wilcoxon signed-rank test|||||||0.895
91614865|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.281||||||"P-value of  quality of social interaction "|Wilcoxon signed-rank test|||||||0.281
91614866|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  sleep "|Wilcoxon signed-rank test|||||||1.00
91614867|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  social support "|Wilcoxon signed-rank test|||||||1.00
91614868|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.943||||||"P-value of  dialysis staff encouragement "|Wilcoxon signed-rank test|||||||0.943
91614869|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  overall health "|Wilcoxon signed-rank test|||||||1.00
91614870|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.09||||||"P-value of  patient satisfaction "|Wilcoxon signed-rank test|||||||0.090
91614871|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.391||||||"P-value of  physical functioning "|Wilcoxon signed-rank test|||||||0.391
91614872|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.438||||||"P-value of  role-physical "|Wilcoxon signed-rank test|||||||0.438
91614873|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.424||||||"P-value of  pain "|Wilcoxon signed-rank test|||||||0.424
91614874|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.169||||||"P-value of  general health "|Wilcoxon signed-rank test|||||||0.169
91614875|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.858||||||"P-value of  emotional well-being "|Wilcoxon signed-rank test|||||||0.858
91614876|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.156||||||"P-value of  role-emotional "|Wilcoxon signed-rank test|||||||0.156
91614877|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.084||||||"P-value of  energy/fatigue "|Wilcoxon signed-rank test|||||||0.084
91614878|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.583||||||"P-value of  SF-12 physical composite "|Wilcoxon signed-rank test|||||||0.583
91614879|NCT01876732|183123614|SUPERIORITY_OR_OTHER|||||||0.358||||||"p-value of  SF-12 mental composite "|Wilcoxon signed-rank test|||||||0.358
91614880|NCT04184622|183123637|SUPERIORITY||Least Square (LS) Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.6|-12.5|||Mixed Models Analysis|||||-12.5|-14.6|<0.001
91614881|NCT04184622|183123637|SUPERIORITY||LS Mean Difference (Net)|-18.9|||<|0.001|TWO_SIDED|95.0|-20.0|-17.8|||Mixed Models Analysis|||||-17.8|-20.0|<0.001
91614882|NCT04184622|183123637|SUPERIORITY||LS Mean Difference (Net)|-20.1|||<|0.001|TWO_SIDED|95.0|-21.2|-19.0|||Mixed Models Analysis|||||-19.0|-21.2|<0.001
91614883|NCT04184622|183123638|SUPERIORITY||Odds Ratio (OR)|23.99|||<|0.001|TWO_SIDED|95.0|17.43|33.02|||Regression, Logistic|||||33.02|17.43|<0.001
91614884|NCT04184622|183123638|SUPERIORITY||Odds Ratio (OR)|73.63|||<|0.001|TWO_SIDED|95.0|46.98|115.39|||Regression, Logistic|||||115.39|46.98|<0.001
91614885|NCT04184622|183123638|SUPERIORITY||Odds Ratio (OR)|75.48|||<|0.001|TWO_SIDED|95.0|47.86|119.03|||Regression, Logistic|||||119.03|47.86|<0.001
91614886|NCT04184622|183123639|SUPERIORITY||LS Mean Difference (Net)|-10.7|||<|0.001|TWO_SIDED|95.0|-11.2|-10.1|||Mixed Models Analysis|||||-10.1|-11.2|<0.001
91614887|NCT04184622|183123640|SUPERIORITY||Odds Ratio (OR)|19.03|||<|0.001|TWO_SIDED|95.0|14.15|25.6|||Regression, Logistic|||||25.60|14.15|<0.001
91614888|NCT04184622|183123640|SUPERIORITY||Odds Ratio (OR)|44.17|||<|0.001|TWO_SIDED|95.0|31.75|61.45|||Regression, Logistic|||||61.45|31.75|<.001
91614889|NCT04184622|183123640|SUPERIORITY||Odds Ratio (OR)|65.64|||<|0.001|TWO_SIDED|95.0|45.94|93.77|||Regression, Logistic|||||93.77|45.94|<.001
91614890|NCT04184622|183123641|SUPERIORITY||Odds Ratio (OR)|17.08|||<|0.001|TWO_SIDED|95.0|11.83|24.66|||Regression, Logistic|||||24.66|11.83|<0.001
91614891|NCT04184622|183123641|SUPERIORITY||Odds Ratio (OR)|51.84|||<|0.001|TWO_SIDED|95.0|35.42|75.88|||Regression, Logistic|||||75.88|35.42|<0.001
91614892|NCT04184622|183123641|SUPERIORITY||Odds Ratio (OR)|66.63|||<|0.001|TWO_SIDED|95.0|45.23|98.16|||Regression, Logistic|||||98.16|45.23|<0.001
91614893|NCT04184622|183123642|SUPERIORITY||Odds Ratio (OR)|36.93|||<|0.001|TWO_SIDED|95.0|18.37|74.22|||Regression, Logistic|||||74.22|18.37|<0.001
91614894|NCT04184622|183123642|SUPERIORITY||Odds Ratio (OR)|109.45|||<|0.001|TWO_SIDED|95.0|54.5|219.81|||Regression, Logistic|||||219.81|54.50|<0.001
91614895|NCT04184622|183123642|SUPERIORITY||Odds Ratio (OR)|150.59|||<|0.001|TWO_SIDED|95.0|74.85|302.97|||Regression, Logistic|||||302.97|74.85|<0.001
91614896|NCT04184622|183123643|SUPERIORITY||LS Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-12.3|-10.0|||Mixed Models Analysis|||||-10.0|-12.3|<0.001
91614897|NCT04184622|183123643|SUPERIORITY||LS Mean Difference (Net)|-16.0|||<|0.001|TWO_SIDED|95.0|-17.2|-14.9|||Mixed Models Analysis|||||-14.9|-17.2|<0.001
91614898|NCT04184622|183123643|SUPERIORITY||LS Mean Difference (Net)|-16.5|||<|0.001|TWO_SIDED|95.0|-17.7|-15.4|||Mixed Models Analysis|||||-15.4|-17.7|<0.001
91614899|NCT04184622|183123644|SUPERIORITY||LS Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|2.9|||ANCOVA|||||2.9|1.6|<0.001
91614900|NCT04184622|183123645|SUPERIORITY||Estimate Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-25.6|-19.8|||Mixed Models Analysis|||||-19.8|-25.6|<0.001
91614901|NCT04184622|183123646|SUPERIORITY||Estimate Difference|-4.91|||<|0.001|TWO_SIDED|95.0|-6.4|-3.41|||Mixed Models Analysis|||||-3.41|-6.40|<0.001
91614902|NCT04184622|183123647|SUPERIORITY||Estimate Difference|7.65|||<|0.001|TWO_SIDED|95.0|5.85|9.49|||Mixed Models Analysis|||||9.49|5.85|<0.001
91614903|NCT04184622|183123648|SUPERIORITY||LS Mean Difference (Net)|-6.8|||<|0.001|TWO_SIDED|95.0|-7.9|-5.7|||Mixed Models Analysis|||||-5.7|-7.9|<0.001
91614904|NCT04184622|183123649|SUPERIORITY||Estimate Difference|-41.2|||<|0.001|TWO_SIDED|95.0|-44.9|-37.3|||Mixed Models Analysis|||||-37.3|-44.9|<0.001
91614905|NCT04184622|183123650|SUPERIORITY||LS Mean Difference (Net)|-13.2|||<|0.0001|TWO_SIDED|95.0|-15.3|-11.1|||Mixed Models Analysis|||||-11.1|-15.3|<.0001
91711672|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.124|TWO_SIDED|90.0|-0.09|2.6|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.60|-0.09|0.124
91711673|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.08||||0.92|TWO_SIDED|90.0|-1.25|1.41|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.41|-1.25|0.920
91711674|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12||||0.887|TWO_SIDED|90.0|-1.46|1.22|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.46|0.887
91614906|NCT04184622|183123650|SUPERIORITY||LS Mean Difference (Net)|-17.7|||<|0.0001|TWO_SIDED|95.0|-19.8|-15.7|||Mixed Models Analysis|||||-15.7|-19.8|<.0001
91614907|NCT04184622|183123650|SUPERIORITY||LS Mean Difference (Net)|-20.7|||<|0.0001|TWO_SIDED|95.0|-22.8|-18.6|||Mixed Models Analysis|||||-18.6|-22.8|<.0001
91614908|NCT04184622|183123651|SUPERIORITY||Hazard Ratio (HR)|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.13|||Regression, Cox|||||0.13|0.03|<0.0001
91614909|NCT04184622|183123652|SUPERIORITY||Hazard Ratio (HR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.07|0.21|||Regression, Cox|||||0.21|0.07|<0.0001
91614910|NCT04184622|183123653|SUPERIORITY||LS Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|95.0|-5.5|-4.6|||Mixed Models Analysis|||||-4.6|-5.5|<0.001
91614911|NCT04184622|183123653|SUPERIORITY||LS Mean Difference (Net)|-7.2|||<|0.001|TWO_SIDED|95.0|-7.7|-6.8|||Mixed Models Analysis|||||-6.8|-7.7|<0.001
91614912|NCT04184622|183123653|SUPERIORITY||LS Mean Difference (Net)|-7.7|||<|0.001|TWO_SIDED|95.0|-8.2|-7.3|||Mixed Models Analysis|||||-7.3|-8.2|<0.001
91711675|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.42||||0.083|TWO_SIDED|90.0|0.08|2.77|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.08|0.083
91711676|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.65||||0.002|TWO_SIDED|90.0|1.29|4.01|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.01|1.29|0.002
91711677|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3||||0.006|TWO_SIDED|90.0|0.94|3.66|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.66|0.94|0.006
91614913|NCT04184622|183123654|SUPERIORITY||LS Mean Difference (Net)|-0.33|||<|0.001|TWO_SIDED|95.0|-0.36|-0.3|||Mixed Models Analysis|||||-0.30|-0.36|<0.001
91614914|NCT04184622|183123654|SUPERIORITY||LS Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.45|-0.38|||Mixed Models Analysis|||||-0.38|-0.45|<0.001
91614915|NCT04184622|183123654|SUPERIORITY||LS Mean Difference (Net)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.48|-0.41|||Mixed Models Analysis|||||-0.41|-0.48|<0.001
91614916|NCT04184622|183123655|SUPERIORITY||LS Mean Difference (Net)|-8.59|||<|0.001|TWO_SIDED|95.0|-9.97|-7.2|||Mixed Models Analysis|||||-7.20|-9.97|<0.001
91614917|NCT04184622|183123655|SUPERIORITY||LS Mean Difference (Net)|-10.59|||<|0.001|TWO_SIDED|95.0|-11.98|-9.21|||Mixed Models Analysis|||||-9.21|-11.98|<0.001
91614918|NCT04184622|183123655|SUPERIORITY||LS Mean Difference (Net)|-11.42|||<|0.001|TWO_SIDED|95.0|-12.8|-10.3|||Mixed Models Analysis|||||-10.30|-12.80|<0.001
91614919|NCT04184622|183123656|SUPERIORITY||Estimate Difference|-6.06|||<|0.001|TWO_SIDED|95.0|-8.32|-3.75|||Mixed Models Analysis|||||-3.75|-8.32|<0.001
91614920|NCT04184622|183123657|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-26.1|-20.4|||Mixed Models Analysis|||||-20.4|-26.1|<0.001
91614921|NCT04184622|183123658|SUPERIORITY||Estimate Difference|-11.3|||<|0.001|TWO_SIDED|95.0|-16.1|-6.2|||Mixed Models Analysis|||||-6.2|-16.1|<0.001
91614922|NCT04184622|183123659|SUPERIORITY||LS Mean Difference (Net)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.0|-3.5|||Mixed Models Analysis|||||-3.5|-5.0|<0.001
91614923|NCT04184622|183123660|SUPERIORITY||Odds Ratio (OR)|29.79|||<|0.0001|TWO_SIDED|95.0|17.73|50.05|||Regression, Logistic|||||50.05|17.73|<.0001
91614924|NCT04184622|183123660|SUPERIORITY||Odds Ratio (OR)|35.05|||<|0.0001|TWO_SIDED|95.0|20.63|59.53|||Regression, Logistic|||||59.53|20.63|<.0001
91614925|NCT04184622|183123660|SUPERIORITY||Odds Ratio (OR)|55.05|||<|0.0001|TWO_SIDED|95.0|29.61|102.34|||Regression, Logistic|||||102.34|29.61|<.0001
91614926|NCT04184622|183123661|SUPERIORITY||LS Mean Difference (Net)|7.7|||<|0.001|TWO_SIDED|95.0|5.6|9.8|||ANCOVA|||||9.8|5.6|<0.001
91614927|NCT04184622|183123661|SUPERIORITY||LS Mean Difference (Net)|10.7|||<|0.001|TWO_SIDED|95.0|8.6|12.8|||ANCOVA|||||12.8|8.6|<0.001
91614928|NCT04184622|183123661|SUPERIORITY||LS Mean Difference (Net)|11.7|||<|0.001|TWO_SIDED|95.0|9.6|13.8|||ANCOVA|||||13.8|9.6|<0.001
91614929|NCT02795988|183123664|SUPERIORITY||Cox proportional hazard regression model|0.603||||0.078|TWO_SIDED|80.0|0.38|0.957||1-sided p-value was calculated from Log-rank test stratified by factor tumor stage which used for randomization at screening.|Log Rank|||||0.957|0.380|0.078
91614930|NCT01617681|183123692|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.96||0.0096|TWO_SIDED|95.0|-13.86|-2.01|||ANCOVA|||||-2.01|-13.86|0.0096
91614931|NCT01617681|183123692|OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|2.07||0.6531|TWO_SIDED|95.0|-5.07|3.2|||ANCOVA|||||3.20|-5.07|0.6531
91614932|NCT01617681|183123693|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.54||0.003|TWO_SIDED|95.0|-12.94|-2.78|||ANCOVA|||||-2.78|-12.94|0.0030
91614933|NCT01617681|183123693|OTHER||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|1.8||0.0042|TWO_SIDED|95.0|-8.98|-1.77|||ANCOVA|||||-1.77|-8.98|0.0042
91614934|NCT01617681|183123694|OTHER||Odds Ratio (OR)|1.68||||0.411|TWO_SIDED|95.0|0.49|5.8|||ANCOVA|||||5.8|0.49|0.411
91614935|NCT01617681|183123694|OTHER||Odds Ratio (OR)|1.45||||0.5443|TWO_SIDED|95.0|0.44|4.79|||ANCOVA|||||4.79|0.44|0.5443
91614936|NCT01617681|183123695|OTHER||Odds Ratio (OR)|0.517||||0.2624|TWO_SIDED|95.0|0.16|1.64|||ANCOVA|||||1.64|0.16|0.2624
91614937|NCT01883440|183123710|SUPERIORITY_OR_OTHER||||||<|0.037|TWO_SIDED||||||Mixed Models Analysis|Linear mixed model||||||<0.037
91614938|NCT01883440|183123711|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Mixed Models Analysis|||In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.||||0.381
91614939|NCT03480282|183123712|OTHER|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This was a descriptive feasibility study.|This was an exploratory and descriptive study to learn if it was feasible to provide PCPs with their patients (aged 76-89) with information about their 10-year prognosis and engage in shared decision making around stopping screening. We measured among the 90 patients that the 45 PCPs saw whether their intentions to be screened declined after seeing their PCP.|This was a descriptive feasibility study.|||<0.001
91614940|NCT03480282|183123712|OTHER|This was a descriptive feasibility study.|Risk Difference (RD)|0.05|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This was a descriptive feasibility study.|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|||<0.001
91614941|NCT01405313|183123713|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|2.5||||0.022|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.022
91614942|NCT01405313|183123714|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|3.0||||0.016|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.016
91655818|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.0334||0.8763|TWO_SIDED|95.0|-2.2|1.87|||Mixed Models Analysis|||Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.87|-2.20|0.8763
91711678|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49||||0.533|TWO_SIDED|90.0|-0.8|1.78|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.78|-0.80|0.533
91614943|NCT03848221|183123715|EQUIVALENCE|||||||0.3|||||||ANOVA|||||||0.30
91614944|NCT03848221|183123716|EQUIVALENCE|||||||0.0002|||||||ANOVA|||||||0.0002
91614945|NCT00109733|183123723|SUPERIORITY_OR_OTHER|||||||0.177|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.177
91614946|NCT00109733|183123723|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
91614947|NCT00109733|183123724|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
91614948|NCT00109733|183123724|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
91614949|NCT00109733|183123725|SUPERIORITY_OR_OTHER|||||||0.653|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.653
91614950|NCT00109733|183123725|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.002
91614951|NCT00109733|183123726|SUPERIORITY_OR_OTHER|||||||0.755|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.755
91614952|NCT00109733|183123726|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
91655819|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4926||0.7491|TWO_SIDED|95.0|-3.42|2.46|||Mixed Models Analysis|||Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.46|-3.42|0.7491
91711679|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02||||0.985|TWO_SIDED|90.0|-1.29|1.26|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.26|-1.29|0.985
91655820|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.9235||0.6141|TWO_SIDED|95.0|-2.29|1.35|||Mixed Models Analysis|||Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.35|-2.29|0.6141
91655821|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.0582||0.5281|TWO_SIDED|95.0|-2.75|1.42|||Mixed Models Analysis|||Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.42|-2.75|0.5281
91711680|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34||||0.665|TWO_SIDED|90.0|-0.95|1.62|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-0.95|0.665
91655822|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.8764||0.6695|TWO_SIDED|95.0|-2.9|4.5|||Mixed Models Analysis|||Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||4.50|-2.90|0.6695
91655823|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.073||0.5607|TWO_SIDED|95.0|-2.74|1.49|||Mixed Models Analysis|||Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.49|-2.74|0.5607
91655824|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.2722||0.8297|TWO_SIDED|95.0|-2.78|2.23|||Mixed Models Analysis|||Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.23|-2.78|0.8297
91655825|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.7065||0.7644|TWO_SIDED|95.0|-2.85|3.87|||Mixed Models Analysis|||Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||3.87|-2.85|0.7644
91711681|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.276|TWO_SIDED|90.0|-0.44|2.15|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.15|-0.44|0.276
91527417|NCT01003184|182930054|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|1.179||0.7034|TWO_SIDED|95.0|-2.77|1.88|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||1.88|-2.77|0.7034
91655826|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.9917||0.5123|TWO_SIDED|95.0|-1.3|2.61|||Mixed Models Analysis|||Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.61|-1.30|0.5123
91655827|NCT01200394|183204625|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|1.1355||0.6838|TWO_SIDED|95.0|-1.77|2.7|||Mixed Models Analysis|||Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.70|-1.77|0.6838
91655828|NCT01200394|183204627|SUPERIORITY||Geometric Mean Ratio|0.9282||||0.5422|TWO_SIDED|95.0|0.7297|1.1807|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.1807|0.7297|0.5422
91711682|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.34||||0.004|TWO_SIDED|90.0|1.04|3.65|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.65|1.04|0.004
91711683|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.011|TWO_SIDED|90.0|0.74|3.35|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.35|0.74|0.011
91711684|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.78||||0.033|TWO_SIDED|90.0|0.41|3.14|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.14|0.41|0.033
91655829|NCT01200394|183204627|SUPERIORITY||Geometric Mean Ratio|0.7998||||0.049|TWO_SIDED|95.0|0.6402|0.999|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9990|0.6402|0.0490
91614953|NCT00109733|183123727|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.041
91614954|NCT00109733|183123727|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.044
91614955|NCT01234402|183123754|OTHER||Hazard Ratio (HR)|0.691||||0.1315|TWO_SIDED|95.0|0.429|1.114|||Log Rank|||Kaplan-Meier methodology estimated median PFS||1.114|0.429|0.1315
91614956|NCT01234402|183123754|OTHER||Hazard Ratio (HR)|1.48||||0.0851|TWO_SIDED|95.0|0.938|2.335|||Log Rank|||Kaplan-Meier methodology estimated median PFS||2.335|0.938|0.0851
91614957|NCT01234402|183123755|OTHER||Hazard Ratio (HR)|1.833||||0.0283|TWO_SIDED|95.0|1.06|3.169|||Log Rank|||||3.169|1.060|0.0283
91614958|NCT01234402|183123755|OTHER||Hazard Ratio (HR)|1.468||||0.155|TWO_SIDED|95.0|0.862|2.501|||Log Rank|||||2.501|0.862|0.1550
91614959|NCT01234402|183123756|OTHER|||||||0.6691|||||||Fisher Exact|||||||0.6691
91614960|NCT01234402|183123756|OTHER|||||||0.1743|||||||Fisher Exact|||||||0.1743
91614961|NCT00506077|183123785|SUPERIORITY_OR_OTHER|||||||0.939||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained longitudinal data analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.939
91711685|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.84||||0.302|TWO_SIDED|90.0|-0.5|2.19|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.19|-0.50|0.302
91711686|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.94||||0.255|TWO_SIDED|90.0|-0.42|2.3|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.30|-0.42|0.255
91614962|NCT00506077|183123786|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-Value Comments (limit 250 characters): The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
91711687|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.08||||0.198|TWO_SIDED|90.0|-0.3|2.46|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.46|-0.30|0.198
91614963|NCT00506077|183123787|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
91614964|NCT00506077|183123788|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Logitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
91614965|NCT00316303|183123793|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
91614966|NCT00316303|183123794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
91614967|NCT00316303|183123795|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
91614968|NCT00316303|183123796|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wald Chi-squared|||||||0.011
91614969|NCT00316303|183123797|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.6
91614970|NCT04174638|183123811|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05. The p value was the value of the total score of the Fluid Control in Hemodialysis Patients Scale.|t-test, 2 sided|||||||<0.001
91614971|NCT04174638|183123812|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||<0.001
91614972|NCT04174638|183123813|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the knowledge sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
91614973|NCT04174638|183123813|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the motivation sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
91614974|NCT04174638|183123817|SUPERIORITY|||||||0.297||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the physical functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.297
91614975|NCT04174638|183123817|SUPERIORITY|||||||0.742||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the mental functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.742
91614976|NCT04174638|183123817|SUPERIORITY|||||||0.719||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the burden of kidney disease sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.719
91614977|NCT04174638|183123817|SUPERIORITY|||||||0.063||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the symptoms/problems sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.063
91614978|NCT04174638|183123817|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the effects of kidney disease on daily life sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||<0.001
91614979|NCT00570739|183123820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0123|TWO_SIDED|95.0|-0.27|-0.03||P-Value is for the LS mean difference between treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||-0.03|-0.27|0.0123
91614980|NCT00570739|183123820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0201|TWO_SIDED|95.0|-0.33|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-0.03|-0.33|0.0201
91614981|NCT00570739|183123820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0239|TWO_SIDED|95.0|-0.36|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.03|-0.36|0.0239
91614982|NCT00570739|183123820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0046|TWO_SIDED|95.0|-0.42|-0.08||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||-0.08|-0.42|0.0046
91614983|NCT00570739|183123821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.1112|TWO_SIDED|95.0|-11.3|1.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 Weeks||1.2|-11.3|0.1112
91614984|NCT00570739|183123821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.2167|TWO_SIDED|95.0|-8.6|2.0|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||2.0|-8.6|0.2167
91614985|NCT00570739|183123821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.7269|TWO_SIDED|95.0|-7.0|4.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||4.9|-7.0|0.7269
91614986|NCT00570739|183123821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.4063|TWO_SIDED|95.0|-8.4|3.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.4|-8.4|0.4063
91614987|NCT00570739|183123821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.4909|TWO_SIDED|95.0|-8.0|3.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||3.9|-8.0|0.4909
91614988|NCT00570739|183123822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.303||||0.7606|TWO_SIDED|95.0|-2.259|1.653||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||1.653|-2.259|0.7606
91614989|NCT00570739|183123822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.015||||0.1782|TWO_SIDED|95.0|-2.477|0.447||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||0.447|-2.477|0.1782
91614990|NCT00570739|183123822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.504||||0.0332|TWO_SIDED|95.0|-2.887|-0.121||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.121|-2.887|0.0332
91614991|NCT00570739|183123822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.861|TWO_SIDED|95.0|-1.805|2.158||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||2.158|-1.805|0.8610
91614992|NCT00570739|183123822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.8196|TWO_SIDED|95.0|-1.599|2.019||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||2.019|-1.599|0.8196
91614993|NCT00570739|183123823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153||||0.1078|TWO_SIDED|95.0|-0.34|0.034||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||0.034|-0.340|0.1078
91614994|NCT00570739|183123823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141||||0.1146|TWO_SIDED|95.0|-0.317|0.035||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||0.035|-0.317|0.1146
91614995|NCT00570739|183123824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9933|TWO_SIDED|95.0|-9.3|9.4||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||9.4|-9.3|0.9933
91614996|NCT00570739|183123824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.8203|TWO_SIDED|95.0|-10.5|8.3||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks LOCF||8.3|-10.5|0.8203
91614997|NCT00570739|183123825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.195|TWO_SIDED|95.0|-17.5|3.6||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.6|-17.5|0.1950
91614998|NCT00570739|183123825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.1583|TWO_SIDED|95.0|-18.3|3.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||3.0|-18.3|0.1583
91655830|NCT01200394|183204627|SUPERIORITY||Geometric Mean Ratio|1.0435||||0.7264|TWO_SIDED|95.0|0.8211|1.3262|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.3262|0.8211|0.7264
91655831|NCT01200394|183204627|SUPERIORITY||Geometric Mean Ratio|1.1154||||0.3733|TWO_SIDED|95.0|0.8761|1.4201|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.4201|0.8761|0.3733
91655832|NCT01835145|183204638|SUPERIORITY|||||||0.7|||||||Chi-squared|||A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.||||0.70
91655833|NCT02708277|183204676|SUPERIORITY_OR_OTHER|||||||0.009|||||||Chi-squared|||||||0.009
91655834|NCT02708277|183204677|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||||||0.303
91655835|NCT02708277|183204678|SUPERIORITY_OR_OTHER|||||||0.606|||||||t-test, 2 sided|||||||0.606
91655836|NCT02708277|183204679|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
91711688|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.68||||0.002|TWO_SIDED|90.0|1.3|4.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.06|1.30|0.002
91711689|NCT00572455|183314669|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.68||||0.046|TWO_SIDED|90.0|0.3|3.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.06|0.30|0.046
91711690|NCT02609386|183314673|OTHER||Cox Proportional Hazard|1.102||||0.6176|TWO_SIDED|95.0|0.6|2.1|||Log Rank|||||2.1|0.6|0.6176
91655837|NCT02739984|183204716|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-64.14|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-68.16|-60.12|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-60.12|-68.16|<0.0001
91655838|NCT02739984|183204717|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-53.14|STANDARD_ERROR_OF_MEAN|2.25|<|0.0001|TWO_SIDED|95.0|-57.56|-48.71|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.71|-57.56|<0.0001
91655839|NCT02739984|183204718|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-67.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-72.1|-62.2|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-62.2|-72.1|<0.0001
91655840|NCT02739984|183204719|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-61.0|-50.5|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-50.5|-61.0|<0.0001
91711691|NCT02609386|183314674|OTHER||Cox Proportional Hazard|1.009||||0.3889|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.3889
91711692|NCT02609386|183314675|OTHER||Cox Proportional Hazard|1.009||||0.5091|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.5091
91711693|NCT03280056|183314676|SUPERIORITY||Odds Ratio (OR)|1.33||||0.453|TWO_SIDED|95.0|0.632|2.798|||Chi-squared|||||2.798|0.632|0.453
91711694|NCT03280056|183314677|SUPERIORITY||Odds Ratio (OR)|0.998||||0.997|TWO_SIDED|95.0|0.416|2.395|||Chi-squared|||||2.395|0.416|0.997
91711695|NCT03280056|183314678|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.926||0.693|TWO_SIDED|95.0|-1.47|2.2|||Mixed Models Analysis|||||2.20|-1.47|0.693
91711696|NCT03280056|183314679|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|6.176||0.804|TWO_SIDED|95.0|-10.65|13.72|||ANCOVA|||||13.72|-10.65|0.804
91655841|NCT02739984|183204720|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-56.56|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-60.28|-52.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-52.85|-60.28|<0.0001
91655842|NCT02739984|183204721|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-46.28|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-50.42|-42.15|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-42.15|-50.42|<0.0001
91655843|NCT02739984|183204722|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-52.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-56.1|-48.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.85|-56.10|<0.0001
91655844|NCT02739984|183204723|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-42.12|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-46.13|-38.11|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.11|-46.13|<0.0001
91711697|NCT00397189|183314723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|STANDARD_DEVIATION|47.0|<|0.05|TWO_SIDED|95.0|-25.3|-6.0|||ANCOVA|||The analysis was a comparison of sleep latency as measured by the sleep diary at Visit 3 in the ITT 65-80 population, using a linear regression model with terms for treatment (Circadin® 2mg vs. Placebo) and baseline sleep latency.||-6|-25.3|<0.05
91711698|NCT00141518|183314748|SUPERIORITY_OR_OTHER||mean change from baseline|-9.4|STANDARD_DEVIATION|17.5||0.017|TWO_SIDED||||||Wilcoxon tests|||Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.017
91614999|NCT00570739|183123826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.3663|TWO_SIDED|95.0|-16.1|6.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.0|-16.1|0.3663
91615000|NCT00570739|183123826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.2524|TWO_SIDED|95.0|-17.9|4.7||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.7|-17.9|0.2524
91615001|NCT00570739|183123827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.051||||0.8158|TWO_SIDED|95.0|-7.828|9.929||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||9.929|-7.828|0.8158
91615002|NCT00570739|183123827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.565||||0.7433|TWO_SIDED|95.0|-10.966|7.836||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.836|-10.966|0.7433
91615003|NCT00570739|183123828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215||||0.5161|TWO_SIDED|95.0|-0.437|0.867||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||0.867|-0.437|0.5161
91615004|NCT00570739|183123828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8319|TWO_SIDED|95.0|-0.581|0.722||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||0.722|-0.581|0.8319
91615005|NCT00570739|183123829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.19|||<|0.0001|TWO_SIDED|95.0|-22.61|-13.76|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-13.76|-22.61|<0.0001
91615006|NCT00570739|183123829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||<|0.0001|TWO_SIDED|95.0|-22.09|-12.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-12.08|-22.09|<0.0001
91615007|NCT00570739|183123829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.33|||<|0.0001|TWO_SIDED|95.0|-20.96|-11.69|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-11.69|-20.96|<0.0001
91615008|NCT00570739|183123830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-15.99|-8.81|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.81|-15.99|<0.0001
91615009|NCT00570739|183123830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.28|||<|0.0001|TWO_SIDED|95.0|-13.23|-5.34|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.34|-13.23|<0.0001
91615010|NCT00570739|183123830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||<|0.0001|TWO_SIDED|95.0|-11.98|-4.67|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Week LOCF||-4.67|-11.98|<0.0001
91615011|NCT00570739|183123831|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.63||||0.2026|TWO_SIDED|95.0|-1.43|6.7|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||6.70|-1.43|0.2026
91615012|NCT00570739|183123831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.4506|TWO_SIDED|95.0|-2.12|4.75|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||4.75|-2.12|0.4506
91615013|NCT00570739|183123831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.2609|TWO_SIDED|95.0|-1.35|4.97|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.97|-1.35|0.2609
91615014|NCT00570739|183123832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81|||<|0.0001|TWO_SIDED|95.0|-11.53|-6.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-6.08|-11.53|<0.0001
91615015|NCT00570739|183123832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.0001|TWO_SIDED|95.0|-10.23|-3.66|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-3.66|-10.23|<0.0001
91615016|NCT00570739|183123832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.09||||0.0001|TWO_SIDED|95.0|-9.14|-3.05|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-3.05|-9.14|0.0001
91615017|NCT00570739|183123833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||0.0171|TWO_SIDED|95.0|-0.33|13.99||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 8 weeks||13.99|-0.33|0.0171
91615018|NCT00570739|183123833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.71|||<|0.0001|TWO_SIDED|95.0|9.66|25.54||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks||25.54|9.66|<0.0001
91615019|NCT00570739|183123833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|||<|0.0001|TWO_SIDED|95.0|11.18|25.74||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks LOCF||25.74|11.18|<0.0001
91711699|NCT00141518|183314749|SUPERIORITY_OR_OTHER||mean change from baseline|0.02|STANDARD_DEVIATION|0.29||0.919|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.919
91711700|NCT00141518|183314750|SUPERIORITY_OR_OTHER||mean change from baseline|0.18|STANDARD_DEVIATION|0.24||0.002|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.002
91711701|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-6.5|STANDARD_DEVIATION|9.6||0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)||||0.001
91711702|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-9.2|STANDARD_DEVIATION|9.0|<|0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)||||<0.001
91711703|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-5.9|STANDARD_DEVIATION|11.2||0.022|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)||||0.022
91711704|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-7.5|STANDARD_DEVIATION|11.6||0.005|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)||||0.005
91711705|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-5.3|STANDARD_DEVIATION|13.9||0.126|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)||||0.126
91711706|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-5.2|STANDARD_DEVIATION|12.3||0.049|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)||||0.049
91711707|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|-3.1|STANDARD_DEVIATION|9.9||0.203|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)||||0.203
91711708|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|0.8|STANDARD_DEVIATION|13.2||0.733|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)||||0.733
91615020|NCT00570739|183123834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.0496|TWO_SIDED|95.0|0.0|5.62|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||5.62|0.0|0.0496
91527418|NCT01003184|182930055|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1061|TWO_SIDED|95.0|-0.32|0.03|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.03|-0.32|0.1061
91711709|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|4.4|STANDARD_DEVIATION|14.3||0.414|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)||||0.414
91711710|NCT00141518|183314777|SUPERIORITY_OR_OTHER||mean change from baseline|2.3|STANDARD_DEVIATION|14.9||0.534|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)||||0.534
91711711|NCT00141518|183314786|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.016
91711712|NCT00141518|183314786|SUPERIORITY_OR_OTHER|||||||0.188|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.188
91711713|NCT00141518|183314787|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.008
91711714|NCT00141518|183314787|SUPERIORITY_OR_OTHER|||||||0.107|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.107
91711715|NCT00141518|183314788|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
91711716|NCT00141518|183314788|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.010
91711717|NCT00141518|183314789|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
91711718|NCT00141518|183314789|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
91711719|NCT00141518|183314790|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.001
91711720|NCT00141518|183314790|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
91711721|NCT00141518|183314791|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||1.000
91711722|NCT00141518|183314791|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.002
91711723|NCT00141518|183314792|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.017
91711724|NCT00141518|183314792|SUPERIORITY_OR_OTHER|||||||0.191|||||||Wilcoxon tests|||||||0.191
91711725|NCT00141518|183314793|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
91711726|NCT00141518|183314793|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||<0.001
91711727|NCT00141518|183314794|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.047
91711728|NCT00141518|183314794|SUPERIORITY_OR_OTHER|||||||0.847|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.847
91711729|NCT00141518|183314795|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.012
91615021|NCT00570739|183123834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.0117|TWO_SIDED|95.0|0.82|6.47|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.47|0.82|0.0117
91615022|NCT00570739|183123834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43||||0.0009|TWO_SIDED|95.0|1.83|7.03|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.03|1.83|0.0009
91615023|NCT00570739|183123835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.56|||<|0.0001|TWO_SIDED|95.0|-14.74|-8.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.38|-14.74|<0.0001
91615024|NCT00570739|183123835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.53||||0.0001|TWO_SIDED|95.0|-13.14|-5.92|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.92|-13.14|0.0001
91655845|NCT02739984|183204724|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-41.06|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|95.0|-43.9|-38.22|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.22|-43.90|<0.0001
91655846|NCT02739984|183204725|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-33.74|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|-36.87|-30.6|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-30.60|-36.87|<0.0001
91655847|NCT02739984|183204726|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|77.9|||<|0.0001|TWO_SIDED|95.0|70.0|83.5|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||83.5|70.0|<0.0001
91655848|NCT02739984|183204727|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|69.1|||<|0.0001|TWO_SIDED|95.0|60.4|75.7|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||75.7|60.4|<0.0001
91655849|NCT02739984|183204728|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|83.5|||<|0.0001|TWO_SIDED|95.0|77.7|87.4|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||87.4|77.7|<0.0001
91711730|NCT00141518|183314795|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.035
91655850|NCT02739984|183204729|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|64.7|||<|0.0001|TWO_SIDED|95.0|57.7|70.3|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||70.3|57.7|<0.0001
91655851|NCT02739984|183204730|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-40.5|STANDARD_ERROR_OF_MEAN|3.87|<|0.0001|TWO_SIDED|95.0|-48.11|-32.9|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-32.90|-48.11|<0.0001
91655852|NCT02739984|183204731|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-32.56|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-39.58|-25.53|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-25.53|-39.58|<0.0001
91655853|NCT02739984|183204732|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-19.25|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-25.95|-12.54|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-12.54|-25.95|<0.0001
91655854|NCT02739984|183204733|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.02|<|0.0001|TWO_SIDED|95.0|-21.6|-5.8|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-5.80|-21.60|<0.0001
91655855|NCT02739984|183204734|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|9.8|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|6.95|12.64|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||12.64|6.95|<0.0001
91711731|NCT00141518|183314796|SUPERIORITY_OR_OTHER|||||||0.599|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.599
91711732|NCT00141518|183314796|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
91655856|NCT02739984|183204735|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|7.37|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|4.19|10.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||10.56|4.19|<0.0001
91711733|NCT00141518|183314797|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.026
91711734|NCT00141518|183314797|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.208
91711735|NCT00141518|183314798|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.010
91711736|NCT00141518|183314798|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.073
91711737|NCT00141518|183314799|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
91711738|NCT00141518|183314799|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.030
91711739|NCT00141518|183314800|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.208
91711740|NCT00141518|183314800|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
91711741|NCT01029262|183314813|SUPERIORITY||Risk Ratio (RR)|10.616|||<|0.001|TWO_SIDED|95.0|2.639|42.702|||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group||||42.702|2.639|<0.001
91711742|NCT01029262|183314814|SUPERIORITY|||||||1|||||||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.||||||1.000
91615025|NCT00570739|183123835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.59|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-4.59|-11.35|<0.0001
91615026|NCT00570739|183123836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.57||||0.0003|TWO_SIDED|95.0|5.76|19.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||19.38|5.76|0.0003
91711743|NCT01029262|183314815|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0||NA for risk ratio is due to 0 responder in placebo group.|P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||||0|< 0.001
91615027|NCT00570739|183123836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.52||||0.0003|TWO_SIDED|95.0|6.64|22.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||22.40|6.64|0.0003
91615028|NCT00570739|183123836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.08|||<|0.0001|TWO_SIDED|95.0|7.95|22.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||22.20|7.95|<0.0001
91615029|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.84||||0.0363|TWO_SIDED|95.0|0.44|13.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||13.24|0.44|0.0363
91711744|NCT01029262|183314816|SUPERIORITY|||||||0.639|TWO_SIDED||||||Log Rank|p-value from log-rank test to compare lenalidomide and placebo.||||||0.639
91711745|NCT01029262|183314817|SUPERIORITY||Risk Ratio (RR)|1.276||||0.252|TWO_SIDED|95.0|0.867|1.877||p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact|||||1.877|0.867|0.252
91711746|NCT01029262|183314819|SUPERIORITY|||||||0.864|TWO_SIDED|||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.864
91711747|NCT01029262|183314820|SUPERIORITY|||||||0.98||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.980
91711748|NCT01029262|183314822|SUPERIORITY|||||||0.823|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Baseline||||0.823
91711749|NCT01029262|183314822|SUPERIORITY|||||||0.371|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 12 (±3 days)||||0.371
91711750|NCT01029262|183314822|SUPERIORITY|||||||0.391|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 24 (±3 days)||||0.391
91615030|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39||||0.0347|TWO_SIDED|95.0|0.46|12.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||12.31|0.46|0.0347
91615031|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.0028|TWO_SIDED|95.0|0.8|3.81||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.81|0.80|0.0028
91615032|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.001|TWO_SIDED|95.0|0.96|3.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.73|0.96|0.0010
91615033|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0006|TWO_SIDED|95.0|3.1|11.21||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||11.21|3.10|0.0006
91615034|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0003|TWO_SIDED|95.0|3.35|10.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||10.91|3.35|0.0003
91615035|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88||||0.175|TWO_SIDED|95.0|-7.04|1.29||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||1.29|-7.04|0.1750
91615036|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23||||0.1007|TWO_SIDED|95.0|-7.1|0.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||0.63|-7.10|0.1007
91615037|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-199.3|||<|0.0001|TWO_SIDED|95.0|-272.9|-125.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-125.8|-272.9|<0.0001
91615038|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-186.1||||0.0001|TWO_SIDED|95.0|-255.9|-116.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-116.3|-255.9|0.0001
91615039|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.0466|TWO_SIDED|95.0|-23.3|-0.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||-0.2|-23.3|0.0466
91615040|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.057|TWO_SIDED|95.0|-21.8|0.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||0.3|-21.8|0.0570
91615041|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.7||||0.0004|TWO_SIDED|95.0|-120.3|-35.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-35.0|-120.3|0.0004
91711751|NCT01029262|183314822|SUPERIORITY|||||||1|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 36 (±3 days)||||1.000
91711752|NCT01029262|183314822|SUPERIORITY|||||||0.508|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 48 (±3 days)||||0.508
91655857|NCT02739984|183204736|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-17.06|STANDARD_ERROR_OF_MEAN|2.98|<|0.0001|TWO_SIDED|95.0|-22.91|-11.21|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-11.21|-22.91|<0.0001
91711753|NCT01029262|183314823|SUPERIORITY|||||||0.323|TWO_SIDED||||||ANOVA|P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.||Week 12||||0.323
91615042|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-69.3||||0.0007|TWO_SIDED|95.0|-109.2|-29.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-29.3|-109.2|0.0007
91615043|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.9||||0.0124|TWO_SIDED|95.0|-195.8|-23.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-23.9|-195.8|0.0124
91615044|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.8||||0.0098|TWO_SIDED|95.0|-187.6|-26.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-26.0|-187.6|0.0098
91615045|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.102|TWO_SIDED|95.0|-35.6|3.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.2|-35.6|0.1020
91655858|NCT02739984|183204737|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.33|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-20.09|-6.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-6.56|-20.09|<0.0001
91655859|NCT01048333|183204742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.002|TWO_SIDED|95.0|1.31|3.35|||Regression, Cox|||||3.35|1.31|0.002
91711754|NCT01029262|183314823|SUPERIORITY|||||||0.071|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.071
91711755|NCT01029262|183314824|SUPERIORITY|||||||0.76|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score|ANOVA|||Week 12||||0.760
91711756|NCT01029262|183314824|SUPERIORITY|||||||0.251|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.251
91711757|NCT01029262|183314825|SUPERIORITY|||||||0.424|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.424
91615046|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4||||0.0997|TWO_SIDED|95.0|-33.8|3.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.0|-33.8|0.0997
91615047|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.7||||0.0069|TWO_SIDED|95.0|-161.6|-25.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-25.9|-161.6|0.0069
91615048|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.4||||0.0052|TWO_SIDED|95.0|-155.2|-27.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-27.5|-155.2|0.0052
91615049|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0524|TWO_SIDED|95.0|-0.01|1.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.90|-0.01|0.0524
91615050|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.0301|TWO_SIDED|95.0|0.1|1.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.91|0.10|0.0301
91615051|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.0416|TWO_SIDED|95.0|0.02|0.89||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.89|0.02|0.0416
91615052|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.0333|TWO_SIDED|95.0|0.04|0.88||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.88|0.04|0.0333
91615053|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.0693|TWO_SIDED|95.0|-0.05|1.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.44|-0.05|0.0693
91615054|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0187|TWO_SIDED|95.0|0.14|1.56||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.56|0.14|0.0187
91655860|NCT01048333|183204742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.534||||0.001|TWO_SIDED|95.0|3.55|12.02|||Regression, Cox|||||12.02|3.55|0.001
91711758|NCT01029262|183314825|SUPERIORITY|||||||0.116|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.116
91711759|NCT01029262|183314826|SUPERIORITY|||||||0.746|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.746
91711760|NCT01029262|183314826|SUPERIORITY|||||||0.46|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||||||0.460
91655861|NCT01048333|183204742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.127||||0.001|TWO_SIDED|95.0|1.77|5.52|||Regression, Cox|||||5.52|1.77|0.001
91655862|NCT04947579|183204753|SUPERIORITY||Stratified difference|2.4||||0.829|TWO_SIDED|95.0|-18.2|22.7|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||22.7|-18.2|0.829
91655863|NCT04947579|183204753|SUPERIORITY||Stratified difference|7.3||||0.512|TWO_SIDED|95.0|-13.8|27.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||27.5|-13.8|0.512
91655864|NCT04947579|183204754|SUPERIORITY||Stratified difference|3.3||||0.725|TWO_SIDED|95.0|-14.9|21.0|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||21.0|-14.9|0.725
91655865|NCT04947579|183204754|SUPERIORITY||Stratfied difference|12.2||||0.219|TWO_SIDED|95.0|-7.2|30.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||30.5|-7.2|0.219
91655866|NCT04947579|183204755|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.167||0.299|TWO_SIDED|95.0|-0.5|0.16|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.16|-0.50|0.299
91655867|NCT04947579|183204755|SUPERIORITY||Difference in Adjusted Means|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.488|TWO_SIDED|95.0|-0.45|0.22|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.22|-0.45|0.488
91655868|NCT04947579|183204756|SUPERIORITY||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.391||0.97|TWO_SIDED|95.0|-0.76|0.79|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.79|-0.76|0.970
91711761|NCT01029262|183314827|SUPERIORITY|||||||0.265|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.265
91711762|NCT01029262|183314827|SUPERIORITY|||||||0.047|TWO_SIDED|||||3\]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.047
91655869|NCT04947579|183204756|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.393||0.668|TWO_SIDED|95.0|-0.95|0.61|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.61|-0.95|0.668
91655870|NCT04947579|183204757|SUPERIORITY||Difference in Adjusted Means|0.06|STANDARD_ERROR_OF_MEAN|0.416||0.89|TWO_SIDED|95.0|-0.77|0.88|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.88|-0.77|0.890
91655871|NCT04947579|183204757|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.417||0.545|TWO_SIDED|95.0|-0.57|1.08|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.08|-0.57|0.545
91655872|NCT04947579|183204758|SUPERIORITY||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.999||0.778|TWO_SIDED|95.0|-2.26|1.7|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||1.70|-2.26|0.778
91655873|NCT04947579|183204758|SUPERIORITY||Difference in Adjusted Means|-1.0|STANDARD_ERROR_OF_MEAN|1.022||0.33|TWO_SIDED|95.0|-3.02|1.03|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.03|-3.02|0.330
91711763|NCT01029262|183314828|SUPERIORITY|||||||0.2909|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.2909
91711764|NCT01029262|183314828|SUPERIORITY|||||||0.0759|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.0759
91711765|NCT01029262|183314829|SUPERIORITY|||||||0.6957|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 12||||0.6957
91711766|NCT01029262|183314829|SUPERIORITY|||||||0.1729|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 24||||0.1729
91711767|NCT01029262|183314830|SUPERIORITY|||||||0.3975|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments.||Week 12||||0.3975
91711768|NCT01029262|183314830|SUPERIORITY|||||||0.1714|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.1714
91711769|NCT01029262|183314831|SUPERIORITY|||||||0.6408|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.6408
91655874|NCT04947579|183204759|SUPERIORITY||Difference in Adjusted Means|-0.82|STANDARD_ERROR_OF_MEAN|1.567||0.6|TWO_SIDED|95.0|-3.93|2.28|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||2.28|-3.93|0.600
91655875|NCT04947579|183204759|SUPERIORITY||Difference in Adjusted Means|-1.31|STANDARD_ERROR_OF_MEAN|1.605||0.416|TWO_SIDED|95.0|-4.49|1.87|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.87|-4.49|0.416
91655876|NCT04947579|183204760|SUPERIORITY||Adjusted Mean|-6.26|STANDARD_ERROR_OF_MEAN|10.741||||95.0|-27.31|14.79||||||||14.79|-27.31|
91655877|NCT04947579|183204760|SUPERIORITY||Adjusted Mean|-18.58|STANDARD_ERROR_OF_MEAN|9.181|||TWO_SIDED|95.0|-36.57|-0.58||||||||-0.58|-36.57|
91655878|NCT04947579|183204760|SUPERIORITY||Adjusted Mean|-12.16|STANDARD_ERROR_OF_MEAN|10.105|||TWO_SIDED|95.0|-31.96|7.65||||||||7.65|-31.96|
91655879|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|-1.2|-0.1|||||Day 7|||-0.1|-1.2|
91655880|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|-2.0|-0.7|||||Day 15|||-0.7|-2.0|
91655881|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.383|||TWO_SIDED|95.0|-3.2|-1.7|||||Day 29|||-1.7|-3.2|
91655882|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.384|||TWO_SIDED|95.0|-3.7|-2.1|||||Day 43|||-2.1|-3.7|
91655883|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|95.0|-4.0|-2.4|||||Day 57|||-2.4|-4.0|
91655884|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|-4.7|-2.9|||||Day 85|||-2.9|-4.7|
91655885|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|0.472|||TWO_SIDED|95.0|-5.4|-3.5|||||Day 113|||-3.5|-5.4|
91655886|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-5.8|-3.8|||||Day 141|||-3.8|-5.8|
91655887|NCT00767325|183204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|95.0|-5.8|-3.9|||||Day 169|||-3.9|-5.8|
91711770|NCT01029262|183314831|SUPERIORITY|||||||0.575|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.5750
91655888|NCT00996736|183204785|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|Mean Difference (Net)|-0.18||||0.006|TWO_SIDED|95.0|-0.3|-0.05|||Regression, Linear|||||-0.05|-0.30|0.006
91655889|NCT00770315|183204866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.2192|TWO_SIDED|95.0|-1.98|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-1.98|0.2192
91655890|NCT00770315|183204866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.0113|TWO_SIDED|95.0|-2.8|-0.36|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.36|-2.80|0.0113
91655891|NCT00770315|183204866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.0015|TWO_SIDED|95.0|-3.3|-0.79|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.79|-3.30|0.0015
91655892|NCT00770315|183204867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0878|TWO_SIDED|95.0|-1.88|0.13|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.13|-1.88|0.0878
91655893|NCT00770315|183204867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0125|TWO_SIDED|95.0|-2.29|-0.28|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.28|-2.29|0.0125
91655894|NCT00770315|183204867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92||||0.0003|TWO_SIDED|95.0|-2.95|-0.88|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.88|-2.95|0.0003
91655895|NCT00770315|183204868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.4781|TWO_SIDED|95.0|-0.96|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-0.96|0.4781
91655896|NCT00770315|183204868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.1695|TWO_SIDED|95.0|-1.21|0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.21|-1.21|0.1695
91655897|NCT00770315|183204868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0118|TWO_SIDED|95.0|-1.67|-0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.21|-1.67|0.0118
91655898|NCT00770315|183204869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.2622|TWO_SIDED|95.0|-0.93|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-0.93|0.2622
91711771|NCT01029262|183314832|SUPERIORITY|||||||0.2848|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments||Week 12||||0.2848
91655899|NCT00770315|183204869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1914|TWO_SIDED|95.0|-0.99|0.2|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.20|-0.99|0.1914
91655900|NCT00770315|183204869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0021|TWO_SIDED|95.0|-1.57|-0.35|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.35|-1.57|0.0021
91711772|NCT01029262|183314832|SUPERIORITY|||||||0.1053|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 1 sided|||Week 24||||0.1053
91655901|NCT00770315|183204870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.19|TWO_SIDED|95.0|-1.26|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-1.26|0.1900
91655902|NCT00770315|183204870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0053|TWO_SIDED|95.0|-1.84|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.84|0.0053
91655903|NCT00770315|183204870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.0058|TWO_SIDED|95.0|-1.89|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.89|0.0058
91655904|NCT03900624|183204882|SUPERIORITY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
91655905|NCT03900624|183204883|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
91655906|NCT03900624|183204884|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
91711773|NCT01029262|183314833|SUPERIORITY|||||||0.042|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.042
91711774|NCT01029262|183314833|SUPERIORITY|||||||0.448|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.448
91711775|NCT01029262|183314834|SUPERIORITY|||||||0.825|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.825
91655907|NCT02999178|183204887|SUPERIORITY||Adjusted mean difference|106.96|STANDARD_ERROR_OF_MEAN|21.15|<|0.0001|TWO_SIDED|95.0|65.42|148.5||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|"Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.~Random effects: time, intercept."|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||148.50|65.42|<.0001
91691901|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2536||||||Cycle 1. No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.2536
91655908|NCT02999178|183204888|SUPERIORITY||Adjusted mean difference|128.2|STANDARD_ERROR_OF_MEAN|29.17|<|0.0001|TWO_SIDED|95.0|70.81|185.59||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||185.59|70.81|<.0001
91655909|NCT02999178|183204889|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.34|STANDARD_ERROR_OF_MEAN|0.84||0.1115|TWO_SIDED|95.0|-0.31|2.98|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||2.98|-0.31|0.1115
91655910|NCT02999178|183204890|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.12||0.1747|TWO_SIDED|95.0|-0.68|3.74|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||3.74|-0.68|0.1747
91655911|NCT02999178|183204891|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.8||||0.3948|TWO_SIDED|95.0|0.48|1.34|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.34|0.48|0.3948
91655912|NCT02999178|183204892|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.67||||0.1985|TWO_SIDED|95.0|0.36|1.24|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.24|0.36|0.1985
91655913|NCT02999178|183204893|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.94||||0.8544|TWO_SIDED|95.0|0.47|1.86|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.86|0.47|0.8544
91655914|NCT02999178|183204894|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.68||||0.3291|TWO_SIDED|95.0|0.32|1.47|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.47|0.32|0.3291
91655915|NCT02999178|183204897|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.49|0.85|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.85|0.49|0.0017
91655916|NCT02999178|183204898|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.64||||0.0081|TWO_SIDED|95.0|0.45|0.89|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.89|0.45|0.0081
91655917|NCT02999178|183204899|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.96|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.96|0.52|
91655918|NCT02999178|183204900|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.63|||||TWO_SIDED|95.0|0.43|0.94|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.94|0.43|
91655919|NCT02999178|183204901|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.5|||||TWO_SIDED|95.0|0.36|0.68|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.68|0.36|
91655920|NCT02999178|183204902|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.46|||||TWO_SIDED|95.0|0.31|0.69|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.69|0.31|
91655921|NCT02999178|183204903|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-3.53|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-6.14|-0.92|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.92|-6.14|
91655922|NCT02999178|183204904|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-4.18|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|-7.48|-0.88|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.88|-7.48|
91655923|NCT02999178|183204905|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-6.09|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|95.0|-9.65|-2.53|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.53|-9.65|
91655924|NCT02999178|183204906|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-7.28|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-11.86|-2.71|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.71|-11.86|
91655925|NCT01244126|183204923|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA by ranks|0.21|STANDARD_DEVIATION|3.0||0.21|TWO_SIDED|95.0|||||Kruskal-Wallis|||The primary outcome of the study was the maximum postoperative FLACC pain score.||||0.21
91655926|NCT01244126|183204924|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA|0.34||||0.34||95.0|||||Kruskal-Wallis|||Kruskall Wallis test||||0.34
91655927|NCT00863746|183204942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9934||||0.4687|TWO_SIDED|95.0|0.8409|1.1735||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||1.1735|0.8409|0.4687
91711776|NCT01029262|183314834|SUPERIORITY|||||||0.568|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.568
91655928|NCT00863746|183204943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6068|||<|0.0001|TWO_SIDED|95.0|0.5139|0.7165||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.7165|0.5139|<0.0001
91655929|NCT00863746|183204944|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.2263|||<|1e-06|TWO_SIDED|95.0|0.1575|0.2952|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.2952|0.1575|<0.000001
91655930|NCT00863746|183204945|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.039||||0.000876|TWO_SIDED|95.0|0.0137|0.0642|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.0642|0.0137|0.000876
91655931|NCT00863746|183204946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542|||<|0.0001|TWO_SIDED|95.0|0.4526|0.6492||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.6492|0.4526|<0.0001
91655932|NCT00863746|183204947|SUPERIORITY_OR_OTHER|||||||0.3121||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.3121
91655933|NCT00863746|183204948|SUPERIORITY_OR_OTHER|||||||0.2948||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.2948
91655934|NCT00863746|183204949|SUPERIORITY_OR_OTHER|||||||0.8344||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.8344
91655935|NCT00863746|183204950|SUPERIORITY_OR_OTHER|||||||0.1438||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.1438
91655936|NCT00863746|183204951|SUPERIORITY_OR_OTHER|||||||0.9228||||||p-value for treatment effect equal to 0.|Mixed Models Analysis|||||||0.9228
91711777|NCT01029262|183314835|SUPERIORITY|||||||0.119|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.119
91524272|NCT04022889|182923716|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-2.5|2.6|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||2.6|-2.5|
91655937|NCT00153803|183204960|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.165|TWO_SIDED|95.0|0.65|1.33|||Log Rank|||||1.33|0.65|0.165
91655938|NCT00153803|183204961|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.32|TWO_SIDED|95.0|0.85|1.63|||Log Rank|||||1.63|0.85|0.32
91655939|NCT03311646|183204995|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.07||||0.92|TWO_SIDED|95.0|-1.27|1.4||alpha=0.05.|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p-value: p=0.27|1.4|-1.27|0.92
91655940|NCT03311646|183204996|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|1.13||||0.15|TWO_SIDED|95.0|-0.41|2.66||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.|Interaction p=0.23|2.66|-0.41|0.15
91655941|NCT03311646|183204997|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|1.77|4.6|||Mixed Models Analysis||Mean Difference=VLNC-NNC|Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.|Interaction p=0.95|4.60|1.77|<0.001
91655942|NCT03311646|183204998|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.2||||0.84|TWO_SIDED|95.0|-2.0|2.5||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p=0.94|2.5|-2.0|0.84
91655943|NCT00067236|183204999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.4239|TWO_SIDED|95.0|||||ANOVA|||Changes from baseline in efficacy parameters at Day 90.||||0.4239
91655944|NCT01439165|183205036|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||Comparison of anti-tetanus seroprotection rate between the two groups||1.2|-0.4|
91655945|NCT01439165|183205036|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.42|||||TWO_SIDED|95.0|-0.3|2.1||||||Comparison of anti-diphtheria seroprotection rates between the two groups||2.1|-0.3|
91655946|NCT01439165|183205037|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-7.12|||||TWO_SIDED|95.0|-12.0|-1.7||||||Comparison of the anti-tetanus booster response rates between the two groups||-1.7|-12.0|
91711778|NCT01029262|183314835|SUPERIORITY|||||||0.172|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.172
91711779|NCT01029262|183314836|SUPERIORITY|||||||0.792|TWO_SIDED|||||The P-values were calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.792
91655947|NCT01439165|183205037|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-0.95|||||TWO_SIDED|95.0|-5.4|4.0||||||Comparison of the anti-diphteria booster response rates between the two groups||4.0|-5.4|
91711780|NCT01029262|183314836|SUPERIORITY|||||||0.279|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.279
91615055|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.5765|TWO_SIDED|95.0|-1.34|0.75||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.75|-1.34|0.5765
91615056|NCT00570739|183123837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.4762|TWO_SIDED|95.0|-1.35|0.63||P-Value is for the LS Mean Difference between treatment group|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.63|-1.35|0.4762
91615057|NCT00570739|183123838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.0652|TWO_SIDED|95.0|-0.14|4.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.57|-0.14|0.0652
91615058|NCT00570739|183123838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74||||0.0137|TWO_SIDED|95.0|0.57|4.92||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.92|0.57|0.0137
91615059|NCT00570739|183123838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.4726|TWO_SIDED|95.0|-0.2|0.09||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotien Particles||0.09|-0.20|0.4726
91615060|NCT00570739|183123838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.5715|TWO_SIDED|95.0|-0.17|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.10|-0.17|0.5715
91711781|NCT01029262|183314837|SUPERIORITY|||||||0.476|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.476
91615061|NCT00570739|183123838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.0083|TWO_SIDED|95.0|0.02|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.02|0.0083
91615062|NCT00570739|183123838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0022|TWO_SIDED|95.0|0.03|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.03|0.0022
91615063|NCT00570739|183123839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.0||||0.0036|TWO_SIDED|95.0|8.6|43.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||43.5|8.6|0.0036
91615064|NCT00570739|183123839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.2||||0.001|TWO_SIDED|95.0|11.2|43.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||43.3|11.2|0.0010
91615065|NCT00570739|183123840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.8||||0.0008|TWO_SIDED|95.0|12.5|47.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||47.0|12.5|0.0008
91615066|NCT00570739|183123840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.7||||0.0002|TWO_SIDED|95.0|14.9|46.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||46.6|14.9|0.0002
91615067|NCT00570739|183123841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0033|TWO_SIDED|95.0|0.9|4.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.3|0.9|0.0033
91615068|NCT00570739|183123841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.0008|TWO_SIDED|95.0|1.2|4.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.4|1.2|0.0008
91615069|NCT00570739|183123842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0035|TWO_SIDED|95.0|-0.44|-0.09||P-Value is for the LS mean difference between the treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-0.09|-0.44|0.0035
91615070|NCT00570739|183123843|SUPERIORITY_OR_OTHER|||||||0.5848||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 4 Weeks||||0.5848
91615071|NCT00570739|183123843|SUPERIORITY_OR_OTHER|||||||0.8147||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 weeks||||0.8147
91615072|NCT00570739|183123843|SUPERIORITY_OR_OTHER|||||||0.4957||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.4957
91615073|NCT00570739|183123843|SUPERIORITY_OR_OTHER|||||||0.0467||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0467
91615074|NCT00570739|183123843|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 16 Weeks LOCF||||0.0589
91615075|NCT00570739|183123843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.0049|TWO_SIDED|95.0|1.38|6.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||6.10|1.38|0.0049
91615076|NCT00570739|183123843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.0092|TWO_SIDED|95.0|1.25|4.76|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.76|1.25|0.0092
91615077|NCT00570739|183123844|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Startified by country||Baseline to 4 Weeks||||0.0008
91615078|NCT00570739|183123844|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0280
91615079|NCT00570739|183123844|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.0414
91711782|NCT01029262|183314837|SUPERIORITY|||||||0.052|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.052
91615080|NCT00570739|183123844|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0840
91615081|NCT00570739|183123844|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0589
91615082|NCT00570739|183123844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0095|TWO_SIDED|95.0|1.21|3.96|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||3.96|1.21|0.0095
91615083|NCT00570739|183123844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.0088|TWO_SIDED|95.0|1.2|3.6|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.60|1.20|0.0088
91615084|NCT00570739|183123845|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||<0.0001
91615085|NCT00570739|183123845|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||<0.0001
91615086|NCT00570739|183123845|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||<0.0001
91615087|NCT00570739|183123845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.59|||<|0.0001|TWO_SIDED|95.0|2.78|11.23|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||11.23|2.78|<0.0001
91615088|NCT00570739|183123845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.53|9.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.10|2.53|<0.0001
91615089|NCT00570739|183123846|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0004
91615090|NCT00570739|183123846|SUPERIORITY_OR_OTHER|||||||0.0326||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0326
91615091|NCT00570739|183123846|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0157
91615092|NCT00570739|183123846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.087|TWO_SIDED|95.0|0.88|7.07|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||7.07|0.88|0.0870
91615093|NCT00570739|183123846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86||||0.00439|TWO_SIDED|95.0|1.03|7.94|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.94|1.03|0.00439
91615094|NCT00570739|183123847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7959|TWO_SIDED|95.0|-1.32|1.72||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.72|-1.32|0.7959
91615095|NCT00570739|183123847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.8371|TWO_SIDED|95.0|-1.28|1.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.57|-1.28|0.8371
91615096|NCT00570739|183123848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033||||0.4584|TWO_SIDED|95.0|-0.0122|0.0055||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0055|-0.0122|0.4584
91615097|NCT00570739|183123848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0035||||0.4039|TWO_SIDED|95.0|-0.0118|0.0048||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0048|-0.0118|0.4039
91615098|NCT00570739|183123849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59|||<|0.0001|TWO_SIDED|95.0|-21.07|-10.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-10.11|-21.07|<0.0001
91615099|NCT00570739|183123850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.46||||0.2289|TWO_SIDED|95.0|-27.53|6.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||6.62|-27.53|0.2289
91615100|NCT00570739|183123850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.1997|TWO_SIDED|95.0|-29.22|6.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||6.14|-29.22|0.1997
91615101|NCT00570739|183123851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.81||||0.0144|TWO_SIDED|95.0|2.57|23.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.05|2.57|0.0144
91615102|NCT00570739|183123851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12||||0.0037|TWO_SIDED|95.0|4.63|23.61||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.61|4.63|0.0037
91615103|NCT00570739|183123851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.79||||0.006|TWO_SIDED|95.0|6.59|39.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.00|6.59|0.0060
91615104|NCT00570739|183123851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.72||||0.0013|TWO_SIDED|95.0|9.71|39.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.73|9.71|0.0013
91615105|NCT00570739|183123851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35||||0.0005|TWO_SIDED|95.0|3.71|13.0|||ANCOVA|||Calculated High Density Lipoprotein-Cholesterol||13.00|3.71|0.0005
91615106|NCT00570739|183123851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.69||||0.0001|TWO_SIDED|95.0|4.27|13.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated High Density Lipoprotein-Cholesterol||13.11|4.27|0.0001
91711783|NCT01029262|183314838|SUPERIORITY||Risk Ratio (RR)|1.759||||0.017|TWO_SIDED|95.0|1.083|2.856||p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|Fisher Exact|||||2.856|1.083|0.017
91655948|NCT01439165|183205038|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC ratio (Adacel/Historical Control)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||Comparison of anti-pertussis toxoid GMCs between Adacel and historical control groups||1.18|0.92|
91655949|NCT01439165|183205038|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|5.22|||||TWO_SIDED|95.0|4.51|6.05||||||Comparison of the anti-FHA GMCs between Adacel and historical Control groups||6.05|4.51|
91655950|NCT01439165|183205038|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.94|||||TWO_SIDED|95.0|2.46|3.51||||||Comparison of the anti-Pertactin GMCs between Adacel and historical Control groups||3.51|2.46|
91655951|NCT01439165|183205038|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.18|||||TWO_SIDED|95.0|1.84|2.6||||||Comparison of the post-vaccination anti-Fimbriae (types 2 and 3) GMCs between Adacel and historical Control groups||2.60|1.84|
91791331|NCT03445156|183460375|OTHER|ANCOVA||||||0.044|||||||ANCOVA|F(2, 273) = 3.16||Hypothesis: Participants who played a violent FPS game were expected to hit the mannequin's head more often than were participants who played either the nonviolent shooting game or the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.044
91791332|NCT03445156|183460375|OTHER|ANCOVA||||||0.17|||||||t-test, 2 sided|t(274) = 2.40||"Hypothesis: Because the nonviolent shooting game rewards other shots, participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||0.17
91655952|NCT01439165|183205039|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|16.12|||||TWO_SIDED|95.0|13.27|18.73||||||comparison of anti-pertussis toxoid booster response rates was performed between the Adacel and historical groups||18.73|13.27|
91655953|NCT01439165|183205039|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) Adacel-Expected Booster|-4.21|||||TWO_SIDED|95.0|-7.23|-1.34||||||Comparison of the anti-FHA booster response rates between the Adacel and historical groups||-1.34|-7.23|
91655954|NCT01439165|183205039|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-18.61|||||TWO_SIDED|95.0|-21.7|-15.6||||||Comparison of the anti-Pertactin booster response rates between Adacel and historical groups||-15.6|-21.7|
91655955|NCT01439165|183205039|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-19.07|||||TWO_SIDED|95.0|-22.3|-16.0||||||Comparison of the anti-Fimbriae (types 2 and 3) booster response rates between Adacel and historical groups||-16.0|-22.3|
91655956|NCT03499964|183205055|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<0.0001
91655957|NCT03499964|183205057|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91655958|NCT01047345|183205060|SUPERIORITY_OR_OTHER||Difference in Percentages|3.5||||0.026|TWO_SIDED|95.0|0.5|6.2|||Miettinen & Nurminen|||||6.2|0.5|0.026
91711784|NCT01468454|183314846|OTHER||Specificity|89.5|||||TWO_SIDED|95.0|75.2|97.1||||||||97.1|75.2|
91655959|NCT01047345|183205061|SUPERIORITY_OR_OTHER||Difference in Percentages|4.0|||||TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||||10.8|-2.8|
91655960|NCT01047345|183205062|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-1.5|0.9|||Miettinen & Nurminen|||||0.9|-1.5|
91711785|NCT01468454|183314846|OTHER||Sensitivity|83.9|||||TWO_SIDED|95.0|72.3|92.0||||||||92|72.3|
91711786|NCT03060291|183314856|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.549|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.549
91711787|NCT03060291|183314856|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.854|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.854
91711788|NCT03060291|183314856|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.469|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.469
91655961|NCT01047345|183205063|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2|||||TWO_SIDED|95.0|-1.7|0.6|||Miettinen & Nurminen|||||0.6|-1.7|
91655962|NCT01047345|183205064|SUPERIORITY_OR_OTHER||Difference in Percentages|10.2|||||TWO_SIDED|95.0|7.5|13.1|||Miettinen & Nurminen|||||13.1|7.5|
91655963|NCT01047345|183205065|SUPERIORITY_OR_OTHER||Seroconversion rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 31||100.0|98.9|<0.001
91655964|NCT01047345|183205065|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 33||100.0|98.9|<0.001
91655965|NCT01047345|183205065|SUPERIORITY_OR_OTHER||Seroconversion Rate|98.3|||<|0.001|TWO_SIDED|95.0|96.7|99.2||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 45||99.2|96.7|<0.001
91711789|NCT03060291|183314857|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.535|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.535
91711790|NCT03060291|183314857|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.081|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.081
91711791|NCT03060291|183314857|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.295|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.295
91615107|NCT00570739|183123852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.8804|TWO_SIDED|95.0|0.63|2.34||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.34|0.63|0.8804
91615108|NCT00570739|183123852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5525|TWO_SIDED|95.0|0.73|2.6||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||2.60|0.73|0.5525
91615109|NCT00570739|183123852|SUPERIORITY_OR_OTHER|||||||0.5648||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.5648
91615110|NCT00570739|183123852|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.3170
91615111|NCT00570739|183123853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.9008|TWO_SIDED|95.0|0.66|4.06||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||4.06|0.66|0.9008
91655966|NCT01047345|183205065|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.6|||<|0.001|TWO_SIDED|95.0|98.6|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 52||100.0|98.6|<0.001
91655967|NCT01047345|183205065|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 58||100.0|98.9|<0.001
91711792|NCT03060291|183314858|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.149|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.149
91711793|NCT03060291|183314858|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.207|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.207
91711794|NCT03060291|183314858|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.871|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.871
91711795|NCT03060291|183314859|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.547|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.547
91615112|NCT00570739|183123853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.9035|TWO_SIDED|95.0|0.6|3.37||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.37|0.60|0.9035
91615113|NCT00570739|183123853|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2874
91615114|NCT00570739|183123853|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4344
91615115|NCT00570739|183123854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-24.61|-14.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-14.63|-24.61|<0.0001
91615116|NCT00570739|183123854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|||<|0.0001|TWO_SIDED|95.0|-23.24|-11.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-11.69|-23.24|<0.0001
91615117|NCT00570739|183123855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||<|0.0001|TWO_SIDED|95.0|-16.26|-8.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-8.69|-16.26|<0.0001
91615118|NCT00570739|183123855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.28|||<|0.0001|TWO_SIDED|95.0|-15.15|-5.41||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-5.41|-15.15|<0.0001
91615119|NCT00570739|183123855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.06||||0.0002|TWO_SIDED|95.0|-13.69|-4.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-4.42|-13.69|0.0002
91615120|NCT00570739|183123856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.0357|TWO_SIDED|95.0|0.27|7.66||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||7.66|0.27|0.0357
91615121|NCT00570739|183123856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.6878|TWO_SIDED|95.0|-5.01|3.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||3.31|-5.01|0.6878
91615122|NCT00570739|183123856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7972|TWO_SIDED|95.0|-4.37|3.36||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.36|-4.37|0.7972
91615123|NCT00570739|183123857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.0001|TWO_SIDED|95.0|-12.02|-5.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.80|-12.02|<0.0001
91615124|NCT00570739|183123857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-12.25|-4.26||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-4.26|-12.25|<0.0001
91615125|NCT00570739|183123857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.23||||0.0002|TWO_SIDED|95.0|-11.03|-3.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.44|-11.03|0.0002
91655968|NCT00995553|183205070|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||MATRICS Working Memory Index||||.06
91655969|NCT00995553|183205070|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||ANOVA|||MATRICS Attention Index||||.09
91791333|NCT03445156|183460375|OTHER|ANCOVA||||||0.449|||||||t-test, 2 sided|t(274) = -0.76||Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's head less often than were participants who played the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.449
91711796|NCT03060291|183314859|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.575|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.575
91711797|NCT03060291|183314859|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.964
91615126|NCT00570739|183123858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0257|TWO_SIDED|95.0|0.43|6.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||6.57|0.43|0.0257
91615127|NCT00570739|183123858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.2238|TWO_SIDED|95.0|-1.32|5.58||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||5.58|-1.32|0.2238
91615128|NCT00570739|183123858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2763|TWO_SIDED|95.0|-1.44|4.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.99|-1.44|0.2763
91615129|NCT00570739|183123859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.98||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.98|-13.68|<0.0001
91615130|NCT00570739|183123859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.67||||0.0004|TWO_SIDED|95.0|-13.4|-3.94||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-3.94|-13.40|0.0004
91655970|NCT00995553|183205071|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||||||.73
91711798|NCT03060291|183314860|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.236|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.236
91615131|NCT00570739|183123859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.09||||0.0004|TWO_SIDED|95.0|-12.5|-3.68||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.68|-12.50|0.0004
91615132|NCT00570739|183123860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8||||0.0007|TWO_SIDED|95.0|5.87|21.74||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||21.74|5.87|0.0007
91615133|NCT00570739|183123860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.58||||0.0901|TWO_SIDED|95.0|-1.83|24.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||24.99|-1.83|0.0901
91615134|NCT00570739|183123860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.45||||0.0918|TWO_SIDED|95.0|-1.71|22.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a||Baseline to 16 Weeks LOCF||22.62|-1.71|0.0918
91615135|NCT00570739|183123861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|15.78||||0.0005|TWO_SIDED|95.0|6.27|25.83||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 8 Weeks||25.83|6.27|0.0005
91615136|NCT00570739|183123861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.07||||0.0011|TWO_SIDED|95.0|6.33|26.02||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||26.02|6.33|0.0011
91615137|NCT00570739|183123861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.33||||0.0009|TWO_SIDED|95.0|5.11|23.84||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||23.84|5.11|0.0009
91615138|NCT00570739|183123862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.29||||0.6523|TWO_SIDED|95.0|-17.5|10.32||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||10.32|-17.50|0.6523
91615139|NCT00570739|183123862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.38||||0.3934|TWO_SIDED|95.0|-17.51|8.77||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||8.77|-17.51|0.3934
91615140|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.9838|TWO_SIDED|95.0|-8.66|8.84||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||8.84|-8.66|0.9838
91655971|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|||<|0.001|TWO_SIDED|95.0|0.06|0.196|||Mixed Models Analysis|||||0.196|0.060|<0.001
91655972|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.077|0.216|||Mixed Models Analysis|||||0.216|0.077|<0.001
91655973|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095||||0.006|TWO_SIDED|95.0|0.027|0.162|||Mixed Models Analysis|||||0.162|0.027|0.006
91655974|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.074|0.205|||Mixed Models Analysis|||||0.205|0.074|<0.001
91615141|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.7157|TWO_SIDED|95.0|-6.73|9.79||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||9.79|-6.73|0.7157
91615142|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|||<|0.0001|TWO_SIDED|95.0|1.25|3.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.63|1.25|<0.0001
91615143|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.0001|TWO_SIDED|95.0|1.27|3.51||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.51|1.27|<0.0001
91615144|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.04||||0.0577|TWO_SIDED|95.0|-0.17|10.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.24|-0.17|0.0577
91615145|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24||||0.039|TWO_SIDED|95.0|0.27|10.22||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.22|0.27|0.0390
91655975|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.259|||Mixed Models Analysis|||||0.259|0.113|<0.001
91655976|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.03|TWO_SIDED|95.0|0.008|0.151|||Mixed Models Analysis|||||0.151|0.008|0.030
91615146|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.49||||0.0044|TWO_SIDED|95.0|-12.61|-2.37||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-2.37|-12.61|0.0044
91615147|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.0118|TWO_SIDED|95.0|-11.09|-1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-1.40|-11.09|0.0118
91615148|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.6||||0.0293|TWO_SIDED|95.0|-209.9|-11.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-11.3|-209.9|0.0293
91615149|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-112.7||||0.0202|TWO_SIDED|95.0|-207.6|-17.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-17.8|-207.6|0.0202
91615150|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.9629|TWO_SIDED|95.0|-15.2|14.5|||ANCOVA|||Intermediate Density Lipoprotein (LDL) Particles||14.5|-15.2|0.9629
91615151|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.7485|TWO_SIDED|95.0|-16.5|11.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein (LDL) Particles||11.9|-16.5|0.7485
91615152|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.6||||0.1007|TWO_SIDED|95.0|-139.7|12.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||12.5|-139.7|0.1007
91615153|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.8||||0.0768|TWO_SIDED|95.0|-134.6|6.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||6.9|-134.6|0.0768
91615154|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.7||||0.4143|TWO_SIDED|95.0|-162.7|67.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||67.3|-162.7|0.4143
91615155|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.9||||0.402|TWO_SIDED|95.0|-157.1|63.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||63.3|-157.1|0.4020
91615156|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.6378|TWO_SIDED|95.0|-29.1|17.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||17.9|-29.1|0.6378
91615157|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.5528|TWO_SIDED|95.0|-29.1|15.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||15.6|-29.1|0.5528
91615158|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.0||||0.373|TWO_SIDED|95.0|-134.8|50.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||50.8|-134.8|0.3730
91655977|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.064|0.204|||Mixed Models Analysis|||||0.204|0.064|<0.001
91655978|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.101|0.242|||Mixed Models Analysis|||||0.242|0.101|<0.001
91655979|NCT00950807|183205078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.003|TWO_SIDED|95.0|0.037|0.173|||Mixed Models Analysis|||||0.173|0.037|0.003
91655980|NCT00659607|183205093|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
91711799|NCT03060291|183314860|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.142|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.142
91655981|NCT00659607|183205094|SUPERIORITY_OR_OTHER|||||||0.2669|||||||Chi-squared|||||||0.2669
91655982|NCT00659607|183205095|SUPERIORITY_OR_OTHER|||||||0.9674|||||||Chi-squared|||||||0.9674
91655983|NCT00659607|183205096|SUPERIORITY_OR_OTHER|||||||0.9207|||||||Chi-squared|||||||0.9207
91655984|NCT00659607|183205097|SUPERIORITY_OR_OTHER|||||||0.8249|||||||Fisher Exact|||||||0.8249
91655985|NCT00659607|183205098|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
91655986|NCT00659607|183205100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.121|4.151|||Chi-squared||The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis|||4.151|1.121|0.0003
91655987|NCT00659607|183205101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.642|6.776|||Chi-squared||The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis|||6.776|1.642|<0.0001
91655988|NCT00659607|183205102|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Chi-squared|||||||0.0075
91655989|NCT00659607|183205103|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||||||0.0007
91655990|NCT00659607|183205104|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Chi-squared|||||||0.0393
91655991|NCT00659607|183205105|SUPERIORITY_OR_OTHER|||||||0.0245|||||||Chi-squared|||||||0.0245
91655992|NCT01822548|183205126|OTHER||||||<|0.05|||||||Regression, Linear|Generalized linear model (GLM)||||||<0.05
91711800|NCT03060291|183314860|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.81|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.810
91655993|NCT01822548|183205126|SUPERIORITY||Slope|0.362|||<|0.05|TWO_SIDED|95.0|0.028|0.695|||ANOVA|adjustment for baseline value of EPC||||0.695|0.028|<0.05
91655994|NCT01822548|183205127|SUPERIORITY||Slope|-0.067|||<|0.05|TWO_SIDED|95.0|-0.358|0.224|||ANOVA|||||0.224|-0.358|<0.05
91655995|NCT01734772|183205143|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|149.38|STANDARD_DEVIATION|37.6||0.9456||90.0|124.388|179.383||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||179.383|124.388|0.9456
91655996|NCT01734772|183205143|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|126.47|STANDARD_DEVIATION|33.3||0.5481||90.0|107.363|148.967||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||148.967|107.363|0.5481
91711801|NCT03060291|183314861|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.599|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.599
91711802|NCT03060291|183314861|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.523|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.523
91711803|NCT03060291|183314861|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.252|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.252
91711804|NCT03060291|183314862|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.867|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.867
91711805|NCT03060291|183314862|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.127|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.127
91655997|NCT01734772|183205143|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|127.01|STANDARD_DEVIATION|31.6||0.5665||90.0|108.047|149.295||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.295|108.047|0.5665
91655998|NCT01734772|183205144|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|164.74|STANDARD_DEVIATION|42.9||0.9841||90.0|133.945|202.619||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||202.619|133.945|0.9841
91655999|NCT01734772|183205144|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|128.61|STANDARD_DEVIATION|39.0||0.6003||90.0|106.37|155.495||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||155.495|106.370|0.6003
91656000|NCT01734772|183205144|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|gMean Ratio|123.82|STANDARD_DEVIATION|36.9||0.4656||90.0|102.695|149.288||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.288|102.695|0.4656
91656001|NCT00720122|183205146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.00558|STANDARD_ERROR_OF_MEAN|0.00653||0.4|TWO_SIDED|95.0|-0.0081|0.0193|||Paired t-test|||A paired t-test was performed. The null hypothesis was that bone density would decrease over 6 months in females with anorexia nervosa, as observed in life course studies.||0.0193|-0.0081|0.40
91656002|NCT00661999|183205154|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.39
91656003|NCT00661999|183205154|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.73
91656004|NCT00661999|183205156|SUPERIORITY_OR_OTHER|||||||0.725||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.7250
91711806|NCT03060291|183314862|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.101|TWO_SIDED||||||t-test, 2 sided||||Mean difference in slope with the web/mobile only as the reference group.|||.101
91711807|NCT00718094|183314863|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
91656005|NCT00661999|183205156|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.8700
91656006|NCT00661999|183205157|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.6639
91656007|NCT00661999|183205157|SUPERIORITY_OR_OTHER|||||||0.566||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.5660
91656008|NCT00661999|183205158|SUPERIORITY_OR_OTHER|||||||0.1124||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.1124
91656009|NCT00661999|183205158|SUPERIORITY_OR_OTHER|||||||0.2051||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.2051
91656010|NCT00661999|183205159|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Log Rank|||||||0.0648
91656011|NCT00661999|183205161|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.61
91656012|NCT00661999|183205161|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.44
91656013|NCT00661999|183205162|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.62
91656014|NCT00661999|183205162|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.30
91711808|NCT02420262|183314877|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D \<0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).|Treatment contrast|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.12|||Mixed Models Analysis|||Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.||0.12|-0.16|<0.0001
91656015|NCT00661999|183205163|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.19
91656016|NCT00661999|183205163|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.17
91656017|NCT00661999|183205164|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.73
91656018|NCT00661999|183205164|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.83
91656019|NCT00661999|183205165|SUPERIORITY_OR_OTHER|||||||0.3852||95.0||||Test Comparison for Week 1 Level|Kruskal-Wallis|||||||0.3852
91791334|NCT03445156|183460375|OTHER|ANCOVA||||||0.645|||||||t-test, 2 sided|t(273) = -0.46||"Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||.645
91615159|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.3764|TWO_SIDED|95.0|-129.0|49.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||49.0|-129.0|0.3764
91615160|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9807|TWO_SIDED|95.0|-1.2|1.17||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.17|-1.20|0.9807
91615161|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8615|TWO_SIDED|95.0|-1.23|1.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.03|-1.23|0.8615
91615162|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0364|TWO_SIDED|95.0|0.04|1.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.14|0.04|0.0364
91615163|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.034|TWO_SIDED|95.0|0.04|1.08||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.08|0.04|0.0340
91615164|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6587|TWO_SIDED|95.0|-0.68|1.07||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.07|-0.68|0.6587
91656020|NCT00661999|183205165|SUPERIORITY_OR_OTHER|||||||0.0663||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0663
91615165|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.6554|TWO_SIDED|95.0|-0.63|1.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.00|-0.63|0.6554
91615166|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.1957|TWO_SIDED|95.0|-2.06|0.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.42|-2.06|0.1957
91615167|NCT00570739|183123863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.1622|TWO_SIDED|95.0|-2.03|0.34||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.34|-2.03|0.1622
91615168|NCT00570739|183123864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.0001|TWO_SIDED|95.0|3.51|8.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||8.48|3.51|<0.0001
91615169|NCT00570739|183123864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.31|||<|0.0001|TWO_SIDED|95.0|3.0|7.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||7.63|3.00|<0.0001
91615170|NCT00570739|183123864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1742|TWO_SIDED|95.0|-0.3|0.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.05|-0.30|0.1742
91615171|NCT00570739|183123864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.187|TWO_SIDED|95.0|-0.28|0.06|||ANCOVA|||Low Density Lipoprotein Particles||0.06|-0.28|0.1870
91615172|NCT00570739|183123864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0063|TWO_SIDED|95.0|0.03|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.03|0.0063
91615173|NCT00570739|183123864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.002|TWO_SIDED|95.0|0.04|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.04|0.0020
91615174|NCT00570739|183123865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4||||0.0022|TWO_SIDED|95.0|8.9|39.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.9|8.9|0.0022
91615175|NCT00570739|183123865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.3||||0.0013|TWO_SIDED|95.0|9.6|39.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.1|9.6|0.0013
91615176|NCT00570739|183123865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.3||||0.0006|TWO_SIDED|95.0|11.5|41.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||41.0|11.5|0.0006
91615177|NCT00570739|183123865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.5||||0.0003|TWO_SIDED|95.0|12.5|40.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||40.6|12.5|0.0003
91615178|NCT00570739|183123865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1257|TWO_SIDED|95.0|-0.4|3.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.5|-0.4|0.1257
91656021|NCT00661999|183205165|SUPERIORITY_OR_OTHER|||||||0.322||95.0||||Test Comparison for Week 16 Level|Kruskal-Wallis|||||||0.3220
91656022|NCT00661999|183205166|SUPERIORITY_OR_OTHER|||||||0.1826||95.0||||Test Comparison for Week 1 Level.|Kruskal-Wallis|||||||0.1826
91656023|NCT00661999|183205166|SUPERIORITY_OR_OTHER|||||||0.0113||95.0||||Test comparison for week 7 level|Kruskal-Wallis|||||||0.0113
91656024|NCT00661999|183205166|SUPERIORITY_OR_OTHER|||||||0.3358||95.0||||Test Comparison for week 16 level|Kruskal-Wallis|||||||0.3358
91656025|NCT00661999|183205167|SUPERIORITY_OR_OTHER|||||||0.9022||95.0||||Test comparison for Baseline level.|Kruskal-Wallis|||||||0.9022
91656026|NCT00661999|183205167|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0002
91656027|NCT00661999|183205167|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Test Comparison for Week 16 Level.|Kruskal-Wallis|||||||0.0022
91656028|NCT00661999|183205168|SUPERIORITY_OR_OTHER|||||||0.1137||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1137
91656029|NCT00661999|183205168|SUPERIORITY_OR_OTHER|||||||0.8042||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.8042
91656030|NCT00661999|183205168|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2016
91656031|NCT00661999|183205169|SUPERIORITY_OR_OTHER|||||||0.1139||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1139
91656032|NCT00661999|183205169|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.0424
91656033|NCT00661999|183205169|SUPERIORITY_OR_OTHER|||||||0.2025||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2025
91656034|NCT01658943|183205210|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Log Rank|||||||0.15
91656035|NCT05905783|183205228|SUPERIORITY||Risk Difference (RD)|13.0|STANDARD_ERROR_OF_MEAN|5.5||0.0183|TWO_SIDED|95.0|2.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|2.2|0.0183
91656036|NCT05905783|183205229|SUPERIORITY||Risk Difference (RD)|15.8|STANDARD_ERROR_OF_MEAN|4.67||0.0007|TWO_SIDED|95.0|6.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.7|0.0007
91656037|NCT05905783|183205230|SUPERIORITY||Risk Difference (RD)|14.7|STANDARD_ERROR_OF_MEAN|4.4||0.0008|TWO_SIDED|95.0|6.1|23.4|||Cochran-Mantel-Haenszel|||||23.4|6.1|0.0008
91656038|NCT05905783|183205231|SUPERIORITY||Risk Difference (RD)|12.3|STANDARD_ERROR_OF_MEAN|6.16||0.0462|TWO_SIDED|95.0|0.2|24.3|||Cochran-Mantel-Haenszel|||||24.3|0.2|0.0462
91656039|NCT05905783|183205232|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|5.84||0.6285|TWO_SIDED|95.0|-14.3|8.6|||Cochran-Mantel-Haenszel|||||8.6|-14.3|0.6285
91524273|NCT04022889|182923717|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|28.9|STANDARD_DEVIATION|16.5|||TWO_SIDED|95.0|18.5|39.4|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||39.4|18.5|
91656040|NCT05905783|183205233|SUPERIORITY||LS Mean Difference|-2.16||||0.0011|TWO_SIDED|95.0|-3.44|-0.88|||Mixed model repeated measures (MMRM)|||||-0.88|-3.44|0.0011
91656041|NCT05905783|183205234|SUPERIORITY||Risk Difference (RD)|24.6|STANDARD_ERROR_OF_MEAN|7.67||0.0013|TWO_SIDED|95.0|9.6|39.7|||Cochran-Mantel-Haenszel|||||39.7|9.6|0.0013
91656042|NCT05905783|183205235|SUPERIORITY||Risk Difference (RD)|16.3|STANDARD_ERROR_OF_MEAN|7.26||0.0245|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|||||30.6|2.1|0.0245
91656043|NCT01396044|183205247|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
91656044|NCT01396044|183205248|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.093
91656045|NCT01396044|183205249|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Chi-squared|||||||0.17
91527419|NCT01003184|182930056|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.4638|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.02|-0.05|0.4638
91656046|NCT01396044|183205250|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
91656047|NCT01396044|183205251|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.36
91656048|NCT01396044|183205253|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
91656049|NCT03008460|183205262|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence interval of the adjusted treatment difference was higher than -15%.|Adjusted treatment difference|-7.61||||0.0907|TWO_SIDED|95.0|-18.45|3.24||P-value for non-inferiority was estimated from the adjusted treatment difference.|Regression, Logistic|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a logistic regression model, including treatment and country as covariates.||3.24|-18.45|0.0907
91656050|NCT03008460|183205263|OTHER||Adjusted treatment difference|-0.18||||0.0428|TWO_SIDED|95.0|-0.36|-0.01|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||-0.01|-0.36|0.0428
91656051|NCT03008460|183205264|OTHER||Adjusted treatment difference|-0.07||||0.4676|TWO_SIDED|95.0|-0.25|0.12|||ANOVA|||"Left colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.12|-0.25|0.4676
91656052|NCT03008460|183205264|OTHER||Adjusted treatment difference|-0.09||||0.3076|TWO_SIDED|95.0|-0.25|0.08|||ANOVA|||"Transverse colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.08|-0.25|0.3076
91656053|NCT03008460|183205264|OTHER||Adjusted treatment difference|-0.24||||0.0155|TWO_SIDED|95.0|-0.44|-0.05|||ANOVA|||"Right colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||-0.05|-0.44|0.0155
91656054|NCT03008460|183205264|OTHER||Adjusted treatment difference|-0.36||||0.0975|TWO_SIDED|95.0|-0.79|0.07|||ANOVA|||"Global score:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.07|-0.79|0.0975
91656055|NCT03008460|183205265|OTHER||Adjusted treatment difference rate|1.3847||||0.2428|TWO_SIDED|95.0|0.8|2.4|||CMH chi-square|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) chi-square method (using the general association statistic), stratified on country.||2.4|0.8|0.2428
91656056|NCT03008460|183205266|OTHER||Adjusted treatment difference rate|24.0219|||<|0.0001|TWO_SIDED|95.0|12.6|45.9|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||45.9|12.6|<0.0001
91711809|NCT02420262|183314878|SUPERIORITY_OR_OTHER||Treatment ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.08|0.17|||Negative binomial regression model||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0.|Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||0.17|0.08|<0.0001
91615179|NCT00570739|183123865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1054|TWO_SIDED|95.0|-0.3|3.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.3|-0.3|0.1054
91615180|NCT00570739|183123866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2971|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||0.03|-0.11|0.2971
91615181|NCT00570739|183123866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2567|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.03|-0.11|0.2567
91615182|NCT00570739|183123866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.1081|TWO_SIDED|95.0|-0.13|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.01|-0.13|0.1081
91615183|NCT00570739|183123866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.079|TWO_SIDED|95.0|-0.17|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.01|-0.17|0.0790
91615184|NCT00570739|183123866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0206|TWO_SIDED|95.0|-0.18|-0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-0.01|-0.18|0.0206
91791335|NCT03445156|183460375|OTHER|Zero-order correlation||||||0.032|||||||Zero-order correlation|||Hypothesis: A positive correlation was expected between the number of violent shooting games participants listed among their three favorite video games and hits to the mannequin's head.||||.032
91791336|NCT02889562|183460394|OTHER|Pearson chi-squared tests or Fisher exact tests||||||1|||||||Chi-squared|||||||1.0
91615185|NCT00570739|183123867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||-1.8|-6.8|0.0009
91615186|NCT00570739|183123867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1184|TWO_SIDED|95.0|-4.5|0.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.5|-4.5|0.1184
91615187|NCT00570739|183123867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0615|TWO_SIDED|95.0|-5.8|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.1|-5.8|0.0615
91615188|NCT00570739|183123867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.3617|TWO_SIDED|95.0|-7.2|2.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||2.6|-7.2|0.3617
91615189|NCT00570739|183123867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2372|TWO_SIDED|95.0|-7.0|1.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.7|-7.0|0.2372
91615190|NCT00570739|183123868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.921||||0.2982|TWO_SIDED|95.0|-0.821|2.663||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||2.663|-0.821|0.2982
91615191|NCT00570739|183123868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.695||||0.2361|TWO_SIDED|95.0|-0.458|1.848||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||1.848|-0.458|0.2361
91615192|NCT00570739|183123868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.218||||0.0413|TWO_SIDED|95.0|-2.388|-0.049|||ANCOVA|||Baseline to 12 Weeks||-0.049|-2.388|0.0413
91615193|NCT00570739|183123868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.434||||0.7858|TWO_SIDED|95.0|-3.583|2.715|||ANCOVA|||Baseline to 16 Weeks||2.715|-3.583|0.7858
91615194|NCT00570739|183123868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493||||0.7314|TWO_SIDED|95.0|-3.321|2.335|||ANCOVA|||Baseline to 16 Weeks LOCF||2.335|-3.321|0.7314
91615195|NCT00570739|183123869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.089||||0.553|TWO_SIDED|95.0|-0.385|0.207||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.207|-0.385|0.5530
91615196|NCT00570739|183123869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.105||||0.4554|TWO_SIDED|95.0|-0.383|0.172||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.172|-0.383|0.4554
91615197|NCT00570739|183123870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8583|TWO_SIDED|95.0|-10.7|8.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||8.9|-10.7|0.8583
91615198|NCT00570739|183123870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7975|TWO_SIDED|95.0|-10.5|8.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||8.1|-10.5|0.7975
91711810|NCT02420262|183314879|SUPERIORITY_OR_OTHER||Treatment difference|-3.57|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.95|||Mixed Models Analysis||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero.|Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||-2.95|-4.19|<0.0001
91711811|NCT00941304|183314887|SUPERIORITY_OR_OTHER||LS Mean Difference|3.34||||0.4739|TWO_SIDED|95.0|-5.94|12.62|||ANCOVA|||||12.62|-5.94|.4739
91615199|NCT00570739|183123871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.233||95.0|-18.5|4.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.5|-18.5|0.2330
91615200|NCT00570739|183123871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.1412|TWO_SIDED|95.0|-19.2|2.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||2.8|-19.2|0.1412
91615201|NCT00570739|183123872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.8192|TWO_SIDED|95.0|-13.7|10.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.8|-13.7|0.8192
91615202|NCT00570739|183123872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.7513|TWO_SIDED|95.0|-13.5|9.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.7|-13.5|0.7513
91615203|NCT00570739|183123873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||0.4301|TWO_SIDED|95.0|-24.156|10.336||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.336|-24.156|0.4301
91656057|NCT03008460|183205267|OTHER||Adjusted treatment difference rate|1.0022||||0.9257|TWO_SIDED|95.0|1.0|1.1|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||1.1|1.0|0.9257
91656058|NCT03008460|183205269|OTHER||Adjusted treatment difference|-0.93||||0.4459|TWO_SIDED|95.0|-3.32|1.47|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.47|-3.32|0.4459
91656059|NCT03008460|183205270|OTHER||Adjusted treatment difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.4|1.03|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.03|0.40|<0.0001
91711812|NCT00941304|183314887|SUPERIORITY_OR_OTHER||LS Mean Difference|6.26||||0.2183|TWO_SIDED|95.0|-3.81|16.34|||ANCOVA|||||16.34|-3.81|.2183
91711813|NCT00941304|183314887|SUPERIORITY_OR_OTHER||LS Mean Difference|8.74||||0.0809|TWO_SIDED|95.0|-1.11|18.56|||ANCOVA|||||18.56|-1.11|.0809
91711814|NCT03293394|183314898|SUPERIORITY||||||=|0.001|||||||ANCOVA|||||||=0.001
91711815|NCT03293394|183314899|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
91711816|NCT03293394|183314900|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
91615204|NCT00570739|183123873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.5369|TWO_SIDED|95.0|-21.661|11.321||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||11.321|-21.661|0.5369
91615205|NCT00570739|183123874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.151||||0.7447|TWO_SIDED|95.0|-1.068|0.765||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.765|-1.068|0.7447
91615206|NCT00570739|183123874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.9476|TWO_SIDED|95.0|-0.853|0.911||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.911|-0.853|0.9476
91615207|NCT00570739|183123875|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||<0.0001
91615208|NCT00570739|183123875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23||||0.0018|TWO_SIDED|95.0|2.06|13.58||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||13.58|2.06|0.0018
91615209|NCT00570739|183123875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.89|10.54||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||10.54|1.89|0.0019
91615210|NCT00570739|183123875|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0005
91615211|NCT00570739|183123875|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0007
91615212|NCT00570739|183123876|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.0104
91615213|NCT00570739|183123876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.2224|TWO_SIDED|95.0|0.53|9.39||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||9.39|0.53|0.2224
91656060|NCT03008460|183205271|OTHER||Adjusted treatment difference rate|1.22||||0.3945|TWO_SIDED|95.0|-1.6|4.05|||ANOVA|||"Dose 1:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||4.05|-1.60|0.3945
91711817|NCT03293394|183314901|SUPERIORITY|||||||0.652|||||||ANCOVA|||||||0.652
91711818|NCT03293394|183314902|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
91711819|NCT03293394|183314903|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
91615214|NCT00570739|183123876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.199|TWO_SIDED|95.0|0.53|9.33||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||9.33|0.53|0.1990
91615215|NCT00570739|183123876|SUPERIORITY_OR_OTHER|||||||0.2778||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2778
91615216|NCT00570739|183123876|SUPERIORITY_OR_OTHER|||||||0.2785||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.2785
91615217|NCT00570739|183123877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.5353|TWO_SIDED|95.0|-2.84|1.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.48|-2.84|0.5353
91615218|NCT00570739|183123877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.5475|TWO_SIDED|95.0|-2.64|1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.40|-2.64|0.5475
91656061|NCT03008460|183205271|OTHER||Adjusted treatment difference rate|6.38||||0.0085|TWO_SIDED|95.0|1.65|11.12|||ANOVA|||"Dose 2:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||11.12|1.65|0.0085
91656062|NCT03008460|183205271|OTHER||Adjusted treatment difference rate|7.48||||0.0036|TWO_SIDED|95.0|2.46|12.5|||ANOVA|||"Global:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||12.50|2.46|0.0036
91711820|NCT03293394|183314904|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
91711821|NCT03293394|183314905|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
91711822|NCT01903993|183314921|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||=|0.0106|TWO_SIDED|95.0|0.52|0.92|||Log rank (Stratified)|||Hazard ratios (HR) were estimated by a Cox regression model.||0.92|0.52|= 0.0106
91711823|NCT01903993|183314922|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|0.59|||=|0.8884|TWO_SIDED|95.0|-7.67|8.85|||Cochran-Mantel-Haenszel|||||8.85|-7.67|= 0.8884
91711824|NCT01903993|183314923|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||=|0.5563|TWO_SIDED|95.0|0.71|1.2|||Log rank (Stratified)|||HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.||1.20|0.71|=0.5563
91711825|NCT01903993|183314924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||=|0.0028|TWO_SIDED|95.0|0.15|0.7|||Log rank (unstratified)|||HR were estimated by a unstratified Cox regression model.||0.70|0.15|= 0.0028
91615219|NCT00570739|183123878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0116||||0.0678|TWO_SIDED|95.0|-0.0241|0.0009||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0009|-0.0241|0.0678
91615220|NCT00570739|183123878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0112||||0.0585|TWO_SIDED|95.0|-0.0228|0.0004||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0004|-0.0228|0.0585
91615221|NCT00570739|183123879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.7051|TWO_SIDED|95.0|-18.64|12.64||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||12.64|-18.64|0.7051
91615222|NCT00570739|183123879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.5267|TWO_SIDED|95.0|-19.72|10.13||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||10.13|-19.72|0.5267
91615223|NCT00570739|183123880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.5882|TWO_SIDED|95.0|0.4|1.83||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.83|0.40|0.5882
91615224|NCT00570739|183123880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7098|TWO_SIDED|95.0|0.44|1.96||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.96|0.44|0.7098
91615225|NCT00570739|183123880|SUPERIORITY_OR_OTHER|||||||0.6835||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.6835
91615226|NCT00570739|183123880|SUPERIORITY_OR_OTHER|||||||0.8461||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.8461
91615227|NCT00570739|183123881|SUPERIORITY_OR_OTHER|||||||0.2079||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||0.2079
91615228|NCT00570739|183123881|SUPERIORITY_OR_OTHER|||||||0.4053||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4053
91615229|NCT00570739|183123881|SUPERIORITY_OR_OTHER|||||||0.5752||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.5752
91615230|NCT00570739|183123881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7994|TWO_SIDED|95.0|0.25|2.29||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.29|0.25|0.7994
91656063|NCT03008460|183205274|OTHER||Adjusted treatment difference|1.05||||0.0015|TWO_SIDED|95.0|0.41|1.69|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using 2-way ANOVA, including treatment and country as covariates.||1.69|0.41|0.0015
91656064|NCT00539539|183205276|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.96|TWO_SIDED|95.0|-0.04|0.05|||t-test, 2 sided|||Average change in cluster-specific rates of ROSC.||0.05|-0.04|0.96
91656065|NCT00539539|183205277|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.71|TWO_SIDED|95.0|-4.9|3.4|||t-test, 2 sided|||Average difference in cluster-specific rates.||3.4|-4.9|0.71
91791337|NCT02889562|183460397|OTHER|t-test and Wilcoxon analysis||||||0.17|||||||t-test, 1 sided|||||||0.17
91791338|NCT01943474|183460399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91656066|NCT00539539|183205278|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.21|TWO_SIDED|95.0|-0.039|0.009|||t-test, 2 sided|By-cluster difference in outcome rates.||Average change in cluster-specific risk difference.||0.009|-0.039|0.21
91656067|NCT00539539|183205279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.016|TWO_SIDED|95.0|0.4|3.4|||Regression, Linear|Difference in means, adjusted for cluster.||Cluster adjusted difference in average CPR fraction.||3.4|0.4|0.016
91656068|NCT00539539|183205280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.005|TWO_SIDED|95.0|0.5|2.7|||Regression, Linear|Adjusted for randomization by cluster.||Cluster adjusted difference in means.||2.7|0.5|0.005
91656069|NCT00539539|183205281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.4|-3.0|||Regression, Linear|||Cluster adjusted difference in average compression rate.||-3.0|-6.4|<0.001
91656070|NCT00539539|183205282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.5|||Regression, Linear|||Cluster adjusted difference in the average rate.||-1.5|-5.2|<0.001
91656071|NCT00539539|183205283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.5|0.7|||Regression, Linear|||Cluster adjusted difference in average rate.||0.7|-0.5|0.73
91656072|NCT02130466|183205301|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.29|0.74|||||Cox regression model|||0.74|0.29|
91711826|NCT03681184|183314973|SUPERIORITY||Difference in Least Squares (LS) Mean|-53.546|STANDARD_ERROR_OF_MEAN|4.3224|<|0.0001|TWO_SIDED|95.0|-62.314|-44.778||P=1.685E-14|MMRM|||The Mixed-Effect Model Repeated Measures (MMRM) includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-44.778|-62.314|<0.0001
91656073|NCT02130466|183205308|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||Cox regression model|||0.95|0.38|
91656074|NCT04529109|183205373|SUPERIORITY|The superiority of the Test lens was concluded if the lower limit of the 95% credible interval was above 0.90.|Mean Proportion|0.9998|STANDARD_DEVIATION|0.0005|||TWO_SIDED|95.0|0.999|1.0|||Bayesian Binary model||Interval presented is a 95% Credible interval.|||1.000|0.999|
91656075|NCT01508936|183205392|SUPERIORITY_OR_OTHER||slope difference|0.3007|STANDARD_ERROR_OF_MEAN|0.2559||0.2407|TWO_SIDED|||||The interaction was tested at the significance level 0.10 using the FAS|Regression, Linear||Active - Placebo|The primary analysis was the linear regression model with model effects including treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count. A significant treatment by baseline eosinophil interaction would indicate that treatment difference varies by the baseline eosinophil count.||||0.2407
91656076|NCT01508936|183205393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.0417||0.0697|TWO_SIDED|95.0|-0.006|0.158||Statistical significance level is 0.05.|Regression, Linear|treatment, blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as fixed effects.|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.158|-0.006|0.0697
91656077|NCT01508936|183205394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.0762||0.1072|TWO_SIDED|95.0|-0.273|0.027||significance level of 0.05|t-test, 2 sided|Fixed effects for treatment, hx of asthma exacerbation, sex, visit, and interaction of treatment and visit; covariates for height and baseline value|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.027|-0.273|0.1072
91656078|NCT01611090|183205415|SUPERIORITY||Hazard Ratio (HR)|0.229|||<|0.0001|TWO_SIDED|95.0|0.183|0.286|||Log Rank|||||0.286|0.183|< 0.0001
91656079|NCT03968224|183205429|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91656080|NCT03968224|183205430|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91656081|NCT03968224|183205431|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91656082|NCT03968224|183205432|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91711827|NCT03681184|183314974|SUPERIORITY||Difference in LS Mean|-0.975|STANDARD_ERROR_OF_MEAN|0.0998|<|0.0001|TWO_SIDED|95.0|-1.177|-0.772||P=1.225E-11|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-0.772|-1.177|<0.0001
91791339|NCT01943474|183460400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91656083|NCT05771428|183205436|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.939||0.9819|TWO_SIDED|95.0|-1.87|1.83|||Mixed-effect Model Repeated Measurement|||||1.83|-1.87|0.9819
91656084|NCT05771428|183205436|SUPERIORITY||LS Mean of Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.931||0.6545|TWO_SIDED|95.0|-2.25|1.42|||Mixed-effect Model Repeated Measurement|||||1.42|-2.25|0.6545
91656085|NCT05771428|183205436|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.928||0.786|TWO_SIDED|95.0|-1.58|2.08|||Mixed-effect Model Repeated Measurement|||||2.08|-1.58|0.7860
91656086|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-2.2|1.0||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.0|-2.2|
91656087|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-4.0|3.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.||3.8|-4.0|
91656088|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.4|-1.6|
91711828|NCT03681184|183314975|SUPERIORITY||Difference in LS Mean|-51.7718|STANDARD_ERROR_OF_MEAN|6.16118|<|0.0001|TWO_SIDED|95.0|-64.2653|-39.2784||P=5.032E-10|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate:creatinine ratio as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-39.2784|-64.2653|<0.0001
91711829|NCT03681184|183314976|SUPERIORITY||Difference in Proportions|0.84|||<|0.0001|TWO_SIDED|95.0|0.55|0.94||P=8.341E-07|Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤1.5 x ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.94|0.55|<0.0001
91615231|NCT00570739|183123881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.996|TWO_SIDED|95.0|0.32|3.03||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.03|0.32|0.9960
91615232|NCT00570739|183123881|SUPERIORITY_OR_OTHER|||||||0.7783||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.7783
91615233|NCT00570739|183123881|SUPERIORITY_OR_OTHER|||||||0.9774||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.9774
91615234|NCT00570739|183123882|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||<0.0001
91615235|NCT00570739|183123882|SUPERIORITY_OR_OTHER|||||||0.4058||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4058
91656089|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.||1.4|-1.6|
91656090|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.9||||||95.0|-5.0|2.9||||||For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.||2.9|-5.0|
91656091|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.5|1.4||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.4|-1.5|
91615236|NCT00570739|183123882|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.0254
91615237|NCT00570739|183123882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1499|TWO_SIDED|95.0|0.74|3.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||3.55|0.74|0.1499
91615238|NCT00570739|183123882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.042|TWO_SIDED|95.0|0.97|4.45||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||4.45|0.97|0.0420
91615239|NCT00570739|183123882|SUPERIORITY_OR_OTHER|||||||0.224||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2240
91615240|NCT00570739|183123882|SUPERIORITY_OR_OTHER|||||||0.0593||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0593
91615241|NCT00570739|183123883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.4794|TWO_SIDED|95.0|0.31|1.4||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.40|0.31|0.4794
91615242|NCT00570739|183123883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.6667|TWO_SIDED|95.0|0.37|1.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.55|0.37|0.6667
91615243|NCT00570739|183123883|SUPERIORITY_OR_OTHER|||||||0.2768||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2768
91615244|NCT00570739|183123883|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4395
91615245|NCT00570739|183123884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.1375|TWO_SIDED|95.0|0.89|6.64||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||6.64|0.89|0.1375
91615246|NCT00570739|183123884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.1996|TWO_SIDED|95.0|0.85|5.82|||Cochran-Mantel-Haenszel|P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.||Baseline to 16 Weeks LOCF||5.82|0.85|0.1996
91615247|NCT00570739|183123884|SUPERIORITY_OR_OTHER|||||||0.0829||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0829
91615248|NCT00570739|183123884|SUPERIORITY_OR_OTHER|||||||0.1037||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.1037
91615249|NCT00739297|183123888|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.01|0.08|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.08|-0.01|
91615250|NCT00739297|183123888|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.1||||||95.0|0.04|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.04|
91615251|NCT00739297|183123888|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|0.02|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|0.02|
91656092|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-7.8|1.0||||||For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.||1.0|-7.8|
91656093|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-3.6|5.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||5.0|-3.6|
91711830|NCT03681184|183314977|SUPERIORITY||Difference in Proportions|0.52||||0.001|TWO_SIDED|95.0|0.23|0.7|||Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.70|0.23|0.0010
91711831|NCT03681184|183314978|SUPERIORITY||Difference in LS Mean|-39.48|STANDARD_ERROR_OF_MEAN|5.181|<|0.0001|TWO_SIDED|95.0|-50.1|-28.87||P=2.862E-08|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-28.87|-50.10|<0.0001
91711832|NCT03681184|183314979|SUPERIORITY||Difference in LS Mean|-8.71|STANDARD_ERROR_OF_MEAN|1.338|<|0.0001|TWO_SIDED|95.0|-11.45|-5.98||P=3.893E-07|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-5.98|-11.45|<0.0001
91711833|NCT04672044|183315019|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
91711834|NCT02453256|183315020|SUPERIORITY||Difference in least square means|-1.73||||0.0983|TWO_SIDED|95.0|-3.78|0.32|||Repeated Measure|||Difference in least square means between the TCZ group and the Placebo group at week 48. Null hypothesis: There is no difference between the TCZ group and the placebo group in mean change in mRSS from baseline to Week 48.||0.32|-3.78|0.0983
91656094|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-9.1|2.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.||2.4|-9.1|
91711835|NCT02453256|183315021|SUPERIORITY||Weighted difference|21.91||||0.0007|TWO_SIDED|95.0|9.2|34.6|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 20% improvement in mRSS.||34.6|9.2|0.0007
91656095|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-8.2|9.5||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||9.5|-8.2|
91711836|NCT02453256|183315021|SUPERIORITY||Weighted difference|4.32||||0.5139|TWO_SIDED|95.0|-8.7|17.3|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 40% improvement in mRSS.||17.3|-8.7|0.5139
91711837|NCT02453256|183315021|SUPERIORITY||Weighted difference|-5.41||||0.3276|TWO_SIDED|95.0|-16.2|5.4|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 60% improvement in mRSS.||5.4|-16.2|0.3276
91711838|NCT02453256|183315022|SUPERIORITY|||||||0.0015||||||P-value from Van Elteren analysis stratified by IL-6 level (\<10; \>=10 pg/mL) at screening.|Van Elteren|||||||0.0015
91711839|NCT02453256|183315023|SUPERIORITY||Difference in least square means|0.167||||0.0001|TWO_SIDED|95.0|0.083|0.25|||Repeated Measure|||||0.250|0.083|0.0001
91711840|NCT02453256|183315024|SUPERIORITY||Difference in least square means|-0.053||||0.4489|TWO_SIDED|95.0|-0.192|0.085|||Repeated Measure|||||0.085|-0.192|0.4489
91711841|NCT02453256|183315025|SUPERIORITY||Difference in least square means|-2.44||||0.4339|TWO_SIDED|95.0|-8.57|3.7|||Repeated Measure|||||3.70|-8.57|0.4339
91711842|NCT02453256|183315026|SUPERIORITY||Difference in least square means|-2.46||||0.4378|TWO_SIDED|95.0|-8.72|3.79|||Repeated Measure|||||3.79|-8.72|0.4378
91711843|NCT02453256|183315027|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0821|TWO_SIDED|95.0|0.37|1.06|||Cox-proportional hazards model|||||1.06|0.37|0.0821
91722415|NCT02512419|183337362|SUPERIORITY||regression parameter (median diff)|37.52|STANDARD_ERROR_OF_MEAN|18.01||0.04|TWO_SIDED||||||quantile regression|Models regressed outcome at 6 months on treatment assigned, baseline value of the outcome and actigraph wear time. Effect sizes reported are adjusted|Effects are unstandardized regression coefficients. They represent difference in median outcome between conditions at 6m controlling for baseline and covariates.|To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjusted||||.04
91656096|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.8|1.6||||||For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||1.6|-1.8|
91656097|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.5||||||95.0|-8.3|0.8||||||For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||0.8|-8.3|
91656098|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.7||||||95.0|-3.9|7.1||||||For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||7.1|-3.9|
91722416|NCT02512419|183337363|SUPERIORITY||Median Difference (Final Values)|42.36|STANDARD_ERROR_OF_MEAN|38.83||0.1|TWO_SIDED||||||quantile regression|||Quantile regression was used.||||0.10
91615252|NCT00739297|183123888|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
91615253|NCT00739297|183123888|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.04|0.13|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.13|0.04|
91615254|NCT00739297|183123889|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.19||||||95.0|0.04|0.34|||||Repeated measures model with terms for treatment (Albuterol/Placebo), dose, treatment-by-dose interaction and baseline FEV1|||0.34|0.04|
91615255|NCT00739297|183123890|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.01|0.12|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.12|-0.01|
91615256|NCT00739297|183123890|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|0.0|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.00|
91615257|NCT00739297|183123890|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
91615258|NCT00739297|183123890|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.03|0.14|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.14|-0.03|
91656099|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-2.3|1.7||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||1.7|-2.3|
91656100|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-1.0||||||95.0|-5.0|2.8||||||For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.8|-5.0|
91656101|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-1.6|2.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.9|-1.6|
91656102|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
91656103|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-2.7||||||95.0|-7.3|1.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.||1.8|-7.3|
91615259|NCT00739297|183123890|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
91615260|NCT00739297|183123891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.03|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.03|
91656104|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
91656105|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated||1.7|-1.6|
91615261|NCT00739297|183123891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.09||||||95.0|0.01|0.17|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.17|0.01|
91615262|NCT00739297|183123891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.01|
91615263|NCT00739297|183123891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|-0.02|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.02|
91615264|NCT00739297|183123891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
91615265|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.54|0.92||||||Public insurance||0.92|0.54|
91615266|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|1.5|2.46||||||Diabetes support service available||2.46|1.50|
91615267|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.38|2.49||||||Baseline HbA1c \> 7.80 (reference:HbA1c≤7.80 median)||2.49|1.38|
91656106|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-4.3|4.1||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated||4.1|-4.3|
91722417|NCT00434434|183337365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.13
91656107|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.7|-1.6|
91656108|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.5||||||95.0|-4.7|3.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.||3.7|-4.7|
91656109|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-3.0|2.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||2.0|-3.0|
91656110|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.4||||||95.0|-0.8|4.2||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated||4.2|-0.8|
91656111|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|4.0||||||95.0|-0.4|8.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||8.7|-0.4|
91656112|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||2.0|-2.3|
91656113|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||2.0|-2.3|
91656114|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|3.8||||||95.0|-1.7|10.9||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||10.9|-1.7|
91656115|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
91656116|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
91722418|NCT00434434|183337365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0133
91656117|NCT00366899|183205448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
91656118|NCT00366899|183205449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.87|1.1||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.87|
91656119|NCT00366899|183205449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.92|1.16||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.92|
91656120|NCT00366899|183205449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.87|1.17||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.87|
91656121|NCT00366899|183205449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.89|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.89|
91656122|NCT00366899|183205449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.83|1.07||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.83|
91656123|NCT00366899|183205449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.07||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.82|
91656124|NCT00366899|183205452|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96||||||95.0|0.72|1.27||||||For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated||1.27|0.72|
91656125|NCT00366899|183205452|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.54|0.96||||||For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.54|
91722419|NCT00434434|183337366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.09
91722420|NCT00434434|183337366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0028
91711844|NCT01243177|183315073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.5|2.8|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.8|-5.5|
91711845|NCT01243177|183315074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.3|2.7|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.7|-5.3|
91656126|NCT00366899|183205453|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.75|1.3||||||or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.75|
91656127|NCT00366899|183205453|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.81|1.3||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.81|
91656128|NCT00366899|183205454|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.65|0.94||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.65|
91722421|NCT03479905|183337410|SUPERIORITY|||||||0.0004|||||||Kruskal-Wallis|||||||0.0004
91791340|NCT01943474|183460401|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91615268|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.15|2.07||||||Baseline HbA1c missing (reference:HbA1c≤7.80 median)||2.07|1.15|
91615269|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.13|1.88||||||Diabetes duration \> 11 years||1.88|1.13|
91656129|NCT00366899|183205454|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.67|1.08||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.67|
91656130|NCT00366899|183205454|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.75||||||95.0|0.63|0.89||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.63|
91656131|NCT00366899|183205454|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.25||||||95.0|0.88|1.79||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.79|0.88|
91791341|NCT01943474|183460402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91615270|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.97|1.0||||||Age (per year increase)||1.00|0.97|
91615271|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|10.5|||||TWO_SIDED|95.0|3.3|33.41||||||Baseline insulin therapy: combination||33.41|3.30|
91615272|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|5.71|||||TWO_SIDED|95.0|1.77|18.37||||||Baseline insulin therapy: prandial only||18.37|1.77|
91615273|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|3.02|5.73||||||Baseline insulin therapy: pre-mixed only||5.73|3.02|
91656132|NCT00366899|183205455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.7|1.08||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.70|
91656133|NCT00366899|183205455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.74|1.22||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.74|
91656134|NCT00366899|183205455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.68|1.13||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.68|
91615274|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. IPC ranges from 1-5 with higher scores indicating more discrimination.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.39|0.65||||||Discrimination domain of the IPC||0.65|0.39|
91711846|NCT00913081|183315087|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow. Because quercetin has not been used to inhibit flushing from niacin in humans, sample size could not be determined statistically. A sample size of 8 men and 8 women was expected to allow separate estimates of effect size, variability, and shape of distribution for men and women.||||0.5
91711847|NCT00913081|183315087|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.8
91711848|NCT00913081|183315087|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.5
91711849|NCT03272347|183315111|OTHER|The 95% confidence intervals (CIs) were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.9|||||TWO_SIDED|95.0|-12.5|18.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||18.3|-12.5|
91711850|NCT03272347|183315111|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|9.6|||||TWO_SIDED|95.0|-3.8|23.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||23.0|-3.8|
91711851|NCT03272347|183315111|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|0.2|||||TWO_SIDED|95.0|-16.0|16.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||16.3|-16.0|
91711852|NCT03272347|183315112|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.1|||||TWO_SIDED|95.0|-12.2|24.4|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.4|-12.2|
91711853|NCT03272347|183315112|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.2|||||TWO_SIDED|95.0|-12.2|24.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.6|-12.2|
91711854|NCT03272347|183315112|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.1|||||TWO_SIDED|95.0|-27.1|14.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||14.8|-27.1|
91615275|NCT01400971|183123892|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Diabetes Distress Scale total score \> 2||0.95|0.57|
91711855|NCT03272347|183315113|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.6|||||TWO_SIDED|95.0|-15.7|20.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.5|-15.7|
91711856|NCT03272347|183315113|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.9|||||TWO_SIDED|95.0|-15.0|20.8|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.8|-15.0|
91711857|NCT03272347|183315113|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-9.7|||||TWO_SIDED|95.0|-29.4|10.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||10.1|-29.4|
91711858|NCT03272347|183315114|OTHER|Based on Miettinen \& Nurminen method|Difference in %|0.2|||||TWO_SIDED|95.0|-13.4|14.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||14.5|-13.4|
91711859|NCT03272347|183315114|OTHER|Based on Miettinen \& Nurminen method|Difference in %|-3.2|||||TWO_SIDED|95.0|-16.4|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-16.4|
91711860|NCT03272347|183315114|OTHER|Based on Miettinen \& Nurminen method|Difference in %|3.2|||||TWO_SIDED|95.0|-10.8|18.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||18.1|-10.8|
91722422|NCT01706328|183337413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.137|TWO_SIDED|95.0|-0.008|0.059|||ANCOVA|||||0.059|-0.008|0.137
91791342|NCT01943474|183460403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91615276|NCT01729598|183123897|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91615277|NCT01729598|183123898|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
91615278|NCT01729598|183123899|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91615279|NCT01729598|183123900|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
91615280|NCT01041573|183123903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||||||0.641
91615281|NCT01041573|183123903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91615282|NCT01323673|183123921|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.|Cochran-Mantel-Haenszel|||||||0.151
91615283|NCT00883558|183123929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.|LS Mean Difference|3.06||||0.3217|ONE_SIDED|95.0||14.11|||Mixed Models Analysis|Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.||A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.||14.11||0.3217
91711861|NCT03272347|183315115|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-9.7|||||TWO_SIDED|95.0|-26.1|6.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||6.6|-26.1|
91615284|NCT01005719|183123965|SUPERIORITY_OR_OTHER|||||||0.0242||95.0||||p-value for 10-15 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0242
91615285|NCT01005719|183123965|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value for 15-20 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0270
91615286|NCT01005719|183123965|SUPERIORITY_OR_OTHER|||||||0.0067||95.0||||p-value for 20-25 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0067
91615287|NCT01005719|183123966|SUPERIORITY_OR_OTHER|||||||0.0465||95.0||||p-value for 10-15 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0465
91656135|NCT00366899|183205455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.69||||||95.0|0.55|0.86||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.55|
91656136|NCT00366899|183205455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.68|1.07||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.68|
91656137|NCT00366899|183205455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.51|0.83||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||0.83|0.51|
91656138|NCT00442936|183205548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.66|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.66|1.40|<0.001
91656139|NCT00442936|183205548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.42|6.0|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||6.00|2.42|<0.001
91656140|NCT00442936|183205549|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.001|TWO_SIDED|95.0|2.02|3.95|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.95|2.02|<0.001
91656141|NCT00442936|183205549|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.47|4.79|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.79|2.47|<0.001
91711862|NCT03272347|183315115|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.2|||||TWO_SIDED|95.0|-21.5|9.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||9.1|-21.5|
91791343|NCT01943474|183460406|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91615288|NCT01005719|183123966|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||p-value for 15-20 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0012
91615289|NCT01005719|183123966|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for 20-25 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||<0.0001
91615290|NCT01005719|183123967|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
91615291|NCT01005719|183123967|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
91615292|NCT01005719|183123967|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
91615293|NCT01005719|183123967|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
91615294|NCT01753076|183123983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.0||||0.12|TWO_SIDED|95.0|-67.9|7.9|||ANCOVA||A negative mean difference means that the direction of effect is in favor of placebo.|||7.9|-67.9|0.120
91615295|NCT01753076|183123984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.139|TWO_SIDED|95.0|-3.1|0.4|||Mixed Models Analysis|||||0.4|-3.1|0.139
91615296|NCT01753076|183123985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.173|TWO_SIDED|95.0|-0.3|0.05|||Random coefficients analysis|||||0.05|-0.30|0.173
91615297|NCT01753076|183123986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127||||0.265|TWO_SIDED|95.0|-0.351|0.097|||Mixed Models Analysis|||||0.097|-0.351|0.265
91615298|NCT01753076|183123987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.125|TWO_SIDED|95.0|-18.7|2.3|||Mixed Models Analysis|||||2.3|-18.7|0.125
91615299|NCT01753076|183123988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.393|TWO_SIDED|95.0|0.36|1.49|||Regression, Logistic|||||1.49|0.36|0.393
91615300|NCT01753076|183123989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.986|TWO_SIDED|95.0|0.34|2.89|||Regression, Cox||Week 48|||2.89|0.34|0.986
91615301|NCT01753076|183123989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.923|TWO_SIDED|95.0|0.53|2.01|||Chi-squared||Week 60|||2.01|0.53|0.923
91615302|NCT01753076|183123990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.642|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|||||1.42|0.81|0.642
91615303|NCT01753076|183123991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|||||TWO_SIDED|95.0|-0.062|0.053||||||||0.053|-0.062|
91615304|NCT01753076|183123992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-2.8|5.5||||||||5.5|-2.8|
91615305|NCT02985450|183124011|OTHER||Mean Difference (Final Values)|513.5|STANDARD_DEVIATION|73.6||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Anti-HBs levels difference: high risk obesity group - low risk obesity group NAFLD patients|||||0.02
91711863|NCT03272347|183315115|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-7.5|||||TWO_SIDED|95.0|-23.9|8.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||8.8|-23.9|
91711864|NCT03272347|183315116|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.2|||||TWO_SIDED|95.0|-23.4|27.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||27.7|-23.4|
91711865|NCT03272347|183315116|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-3.7|||||TWO_SIDED|95.0|-29.6|22.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||22.1|-29.6|
91711866|NCT03272347|183315116|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-1.3|||||TWO_SIDED|95.0|-27.7|25.2|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||25.2|-27.7|
91711867|NCT03272347|183315118|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|78.4|||||TWO_SIDED|95.0|18.8|138.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||138.1|18.8|
91711868|NCT03272347|183315118|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|50.7|||||TWO_SIDED|95.0|-31.7|133.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||133.1|-31.7|
91711869|NCT03272347|183315118|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.8|||||TWO_SIDED|95.0|-63.0|64.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.7|-63.0|
91615306|NCT00069576|183124013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.14|TWO_SIDED|97.0|0.72|1.07|||Chi-squared|||For Total Composite End Point||1.07|0.72|0.14
91615307|NCT00069576|183124013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.75|TWO_SIDED|97.0|0.73|1.53|||Chi-squared|||Analysis for Hypoglycemia||1.53|0.73|0.75
91656142|NCT00442936|183205550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.54|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.54|<0.001
91711870|NCT03272347|183315119|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-74.1|75.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||75.3|-74.1|
91711871|NCT03272347|183315119|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|1.5|||||TWO_SIDED|95.0|-70.7|73.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||73.8|-70.7|
91656143|NCT00442936|183205550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.89|3.61|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|1.89|<0.001
91656144|NCT00442936|183205551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.49|2.82|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.82|1.49|<0.001
91656145|NCT00442936|183205551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37|||<|0.001|TWO_SIDED|95.0|1.73|3.25|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.25|1.73|<0.001
91656146|NCT00442936|183205552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.25|2.39|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.39|1.25|<0.001
91711872|NCT03272347|183315119|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-80.8|||||TWO_SIDED|95.0|-165.6|4.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||4.0|-165.6|
91711873|NCT03272347|183315120|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-25.5|||||TWO_SIDED|95.0|-134.8|83.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||83.8|-134.8|
91711874|NCT03272347|183315120|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.6|||||TWO_SIDED|95.0|-212.1|-3.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-3.1|-212.1|
91791344|NCT01943474|183460407|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91615308|NCT00069576|183124013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74||||0.12|TWO_SIDED|97.0|0.49|1.12|||Chi-squared|||Analysis for hyperbilirubinemia||1.12|0.49|0.12
91615309|NCT00069576|183124013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.07|TWO_SIDED|97.0|0.57|1.05|||Chi-squared|||Analysis for elevated cord-blood C-peptide level||1.05|0.57|0.07
91615310|NCT00069576|183124013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.33|TWO_SIDED|97.0|0.1|2.2|||Chi-squared|||Analysis for birth trauma||2.20|0.10|0.33
91615311|NCT00069576|183124014|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
91615312|NCT00069576|183124015|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|97.0|0.32|0.76|||Chi-squared|||||0.76|0.32|<0.001
91615313|NCT00069576|183124016|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.001|TWO_SIDED|97.0|0.26|0.66|||Chi-squared|||||0.66|0.26|<0.001
91615314|NCT00069576|183124017|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.27|TWO_SIDED|97.0|0.53|1.23|||Chi-squared|||||1.23|0.53|0.27
91615315|NCT00069576|183124018|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91615316|NCT00069576|183124019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.49|TWO_SIDED|97.0|0.7|1.99|||Chi-squared|||||1.99|0.70|0.49
91615317|NCT00069576|183124020|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91656147|NCT00442936|183205552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.13|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.13|1.13|0.006
91656148|NCT00442936|183205553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.002|TWO_SIDED|95.0|1.47|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|1.47|0.002
91656149|NCT00442936|183205553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.15|10.51|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||10.51|3.15|<0.001
91656150|NCT00442936|183205554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.026|TWO_SIDED|95.0|1.07|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.07|0.026
91711875|NCT03272347|183315120|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-132.4|||||TWO_SIDED|95.0|-242.9|-21.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-21.9|-242.9|
91615318|NCT00069576|183124021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.19|TWO_SIDED|97.0|0.51|1.18|||Chi-squared|||||1.18|0.51|0.19
91615319|NCT00069576|183124022|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.32|TWO_SIDED|97.0|0.44|1.36|||Chi-squared|||||1.36|0.44|0.32
91615320|NCT00069576|183124023|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.33|TWO_SIDED|97.0|0.26|1.67|||Chi-squared|||||1.67|0.26|0.33
91656151|NCT00442936|183205554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.08|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|2.08|<0.001
91656152|NCT00442936|183205555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|95.0|1.13|4.47|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.47|1.13|0.021
91656153|NCT00442936|183205555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.001|TWO_SIDED|95.0|2.78|9.76|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||9.76|2.78|<0.001
91656154|NCT02428699|183205558|SUPERIORITY||Mean Difference (Net)|5.16|||<|0.0001|TWO_SIDED|95.0|2.79|7.53|||ANCOVA|Subject as random effect,treatment and period as fixed effects,subject and period level baseline values for plasma total and free acids as covariates|Difference is test minus reference such that a positive difference favors the test treatment.|||7.53|2.79|<.0001
91656155|NCT03127137|183205570|SUPERIORITY|||||||0.05||||||The reported p-value was calculated.|Fisher Exact|||||||.05
91711876|NCT03272347|183315121|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-65.6|||||TWO_SIDED|95.0|-195.3|64.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.0|-195.3|
91711877|NCT03272347|183315121|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-61.0|||||TWO_SIDED|95.0|-188.7|66.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||66.8|-188.7|
91711878|NCT03272347|183315121|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.1|||||TWO_SIDED|95.0|-231.2|16.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||16.9|-231.2|
91615321|NCT00069576|183124024|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|97.0|0.81|1.29|||Chi-squared|||||1.29|0.81|0.86
91615322|NCT00069576|183124025|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.02|TWO_SIDED|97.0|0.64|0.99|||Chi-squared|||||0.99|0.64|0.02
91615323|NCT00069576|183124026|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.02|TWO_SIDED|97.0|0.14|0.97|||Chi-squared|||||0.97|0.14|0.02
91615324|NCT00069576|183124027|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46||||0.02|TWO_SIDED|97.0|0.22|0.97|||Chi-squared|||||0.97|0.22|0.02
91615325|NCT00069576|183124028|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.01|TWO_SIDED|97.0|0.42|0.96|||Chi-squared|||||0.96|0.42|0.01
91615326|NCT00069576|183124029|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615327|NCT00069576|183124030|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615328|NCT00069576|183124031|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.71|1.1||||||||1.10|0.71|
91615329|NCT00069576|183124032|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.65|1.69||||||||1.69|0.65|
91615330|NCT00069576|183124033|SUPERIORITY||Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.74|2.05||||||||2.05|0.74|
91615331|NCT00069576|183124034|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
91615332|NCT00069576|183124035|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91615333|NCT00905307|183124036|SUPERIORITY_OR_OTHER||Treatment difference|-4.7||||0.2846|TWO_SIDED|95.0|-10.2|0.82||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.82|-10.2|0.2846
91615334|NCT00905307|183124036|SUPERIORITY_OR_OTHER||Treatment difference|-1.44||||0.6066|TWO_SIDED|95.0|-6.96|4.07||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||4.07|-6.96|0.6066
91711879|NCT03272347|183315123|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|4.9|||||TWO_SIDED|95.0|-20.3|29.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||29.6|-20.3|
91615335|NCT00905307|183124036|SUPERIORITY_OR_OTHER||Treatment difference|-3.86||||0.3293|TWO_SIDED|95.0|-9.32|1.59||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.59|-9.32|0.3293
91615336|NCT00905307|183124036|SUPERIORITY_OR_OTHER||Treatment difference|4.62||||0.2263|TWO_SIDED|95.0|-2.89|12.12|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||12.12|-2.89|0.2263
91615337|NCT00905307|183124036|SUPERIORITY_OR_OTHER||Treatment difference|-3.64||||0.3074|TWO_SIDED|95.0|-10.7|3.38|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||||3.38|-10.7|0.3074
91615338|NCT00905307|183124037|SUPERIORITY_OR_OTHER||Treatment difference|1.61||||0.1807|TWO_SIDED|95.0|-0.75|3.97|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||3.97|-0.75|0.1807
91615339|NCT00905307|183124037|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.1313|TWO_SIDED|95.0|-3.24|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-3.24|0.1313
91656156|NCT03127137|183205571|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.82|2.86||||||||2.86|.82|
91656157|NCT04424407|183205572|OTHER|||||||0.008||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Conscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Conscious Fear \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.008
91656158|NCT04424407|183205572|OTHER|||||||0.08||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Conscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Conscious Threat \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.08
91656159|NCT04424407|183205572|OTHER|||||||0.49||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Conscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Conscious Anger \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.49
91656160|NCT04424407|183205573|OTHER|||||||0.99||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Nonconscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Nonconscious Fear \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.99
91656161|NCT04424407|183205573|OTHER|||||||0.99||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Nonconscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Nonconscious Threat \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.99
91656162|NCT04424407|183205574|OTHER|||||||0.65||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (2) in the Emotion Regulation Scenes task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Emotion Regulation Scenes task Negative \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.65
91615340|NCT00905307|183124037|SUPERIORITY_OR_OTHER||Treatment difference|-0.13||||0.8879|TWO_SIDED|95.0|-1.96|1.69|||ANCOVA|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.69|-1.96|0.8879
91615341|NCT00905307|183124037|SUPERIORITY_OR_OTHER||Treatment difference|-1.24||||0.1764|TWO_SIDED|95.0|-3.05|0.56|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.56|-3.05|0.1764
91615342|NCT00905307|183124037|SUPERIORITY_OR_OTHER||Treatment difference|-1.79||||0.1111|TWO_SIDED|95.0|-4.0|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-4.00|0.1111
91615343|NCT00905307|183124038|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.2896|TWO_SIDED|95.0|-0.86|2.86|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.86|-0.86|0.2896
91615344|NCT00905307|183124038|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.3701|TWO_SIDED|95.0|-1.94|0.72|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.72|-1.94|0.3701
91615345|NCT00905307|183124038|SUPERIORITY_OR_OTHER||Treatment difference|-0.35||||0.6074|TWO_SIDED|95.0|-1.69|0.99|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.99|-1.69|0.6074
91615346|NCT00905307|183124038|SUPERIORITY_OR_OTHER||Treatment difference|-0.73||||0.2777|TWO_SIDED|95.0|-2.05|0.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.59|-2.05|0.2777
91656163|NCT04424407|183205574|OTHER|||||||0.65||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (2) in the Emotion Regulation Scenes task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Emotion Regulation Scenes task Look Negative \> Decrease Negative amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.65
91615347|NCT00905307|183124038|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.8611|TWO_SIDED|95.0|-1.9|1.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.59|-1.90|0.8611
91615348|NCT00905307|183124039|SUPERIORITY_OR_OTHER||Treatment difference|-2.36||||0.3726|TWO_SIDED|95.0|-7.57|2.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.85|-7.57|0.3726
91615349|NCT00905307|183124039|SUPERIORITY_OR_OTHER||Treatment difference|3.8||||0.0664|TWO_SIDED|95.0|-0.26|7.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||7.85|-0.26|0.0664
91615350|NCT00905307|183124039|SUPERIORITY_OR_OTHER||Treatment difference|2.2||||0.2944|TWO_SIDED|95.0|-1.92|6.32|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||6.32|-1.92|0.2944
91615351|NCT00905307|183124039|SUPERIORITY_OR_OTHER||Treatment difference|3.86||||0.0596|TWO_SIDED|95.0|-0.16|7.89|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||7.89|-0.16|0.0596
91656164|NCT04424407|183205575|OTHER|||||||0.86||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-dACC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.86
91656165|NCT04424407|183205575|OTHER|||||||0.86||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-dmPFC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.86
91656166|NCT04424407|183205575|OTHER|||||||0.83||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-pACC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.83
91656167|NCT04424407|183205575|OTHER|||||||0.23||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-sgACC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.23
91656168|NCT04424407|183205575|OTHER|||||||0.83||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-vmPFC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.83
91656169|NCT04424407|183205576|OTHER||||||<|0.0001||||||P-values are from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in depression symptom severity score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
91656170|NCT04424407|183205577|OTHER|||||||0.002||||||P-values are from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in sleep efficiency was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.002
91656171|NCT04424407|183205578|OTHER||||||<|0.0001||||||P-values are from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in suicidal ideation score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
91656172|NCT04424407|183205579|OTHER|||||||0.03||||||P-values are uncorrected from ordinal logistic regression model. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|A significant p-value here means that treatment was associated with reduced odds of being in a higher risk category.||Analysis of change in suicidal risk was done by applying ordinal logistic regression (proportional odds model) testing the effect of treatment-time on the probability of being in a higher risk category. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.03
91656173|NCT04424407|183205585|OTHER|||||||0.28|||||||Mixed Models Analysis|||Analysis of change in sleep onset latency (PSG) was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.28
91711880|NCT03272347|183315123|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|9.5|||||TWO_SIDED|95.0|-15.4|33.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||33.5|-15.4|
91711881|NCT03272347|183315123|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-5.3|||||TWO_SIDED|95.0|-30.6|20.7|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.7|-30.6|
91711882|NCT03272347|183315124|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-17.9|
91656174|NCT04424407|183205586|OTHER|||||||0.33||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in number of awakenings derived from PSG was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.33
91711883|NCT03272347|183315124|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.2|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.2|-17.9|
91711884|NCT03272347|183315124|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|3.8|||||TWO_SIDED|95.0|-11.5|20.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.6|-11.5|
91711885|NCT05076604|183315160|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||Intraoperative packed red blood cell transfusion||||0.354
91711886|NCT05076604|183315160|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||Postoperative red blood cell transfusion||||0.314
91656175|NCT04424407|183205587|OTHER|||||||0.013||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in wake after sleep onset (WASO) was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.013
91656176|NCT04424407|183205588|OTHER|||||||0.66||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG TST was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.66
91656177|NCT04424407|183205589|OTHER|||||||0.96||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Delta absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.96
91656178|NCT04424407|183205589|OTHER|||||||0.23||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Theta absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.23
91656179|NCT04424407|183205589|OTHER|||||||0.11||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Alpha absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.11
91656180|NCT04424407|183205589|OTHER|||||||0.44||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Sigma absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.44
91656181|NCT04424407|183205589|OTHER|||||||0.68||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Beta-1 absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.68
91656182|NCT04424407|183205589|OTHER|||||||0.74||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Beta-2 absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.74
91656183|NCT04424407|183205589|OTHER|||||||0.84||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Gamma absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.84
91656184|NCT04424407|183205590|OTHER||||||<|0.0001||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in insomnia symptom severity score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
91656185|NCT04424407|183205591|OTHER||||||<|0.0001||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in SF-36 Mental Component Score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
91711887|NCT00472732|183315161|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in posterior cingulate gray matter will be the same in OTCD patients as in controls.||||0.003
91711888|NCT00472732|183315161|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in parietal white matter will be the same in OTCD patients as in controls.||||<0.001
91711889|NCT00472732|183315161|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in posterior cingulate gray matter would be the same for OTCD patients as for controls.||||0.001
91711890|NCT00472732|183315161|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in parietal white matter would be the same for OTCD patients as for controls.||||<0.001
91656186|NCT04424407|183205591|OTHER|||||||0.94||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in SF-36 Physical Component Score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.94
91656187|NCT04424407|183205592|OTHER||||||<|0.0001||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in anxiety symptom severity score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
91656188|NCT01880073|183205603|OTHER||Proportion|0.875|||||TWO_SIDED|95.0|0.74|1.0||||||||1.00|0.74|
91656189|NCT01880073|183205604|OTHER||Proportion|0.125|||||TWO_SIDED|95.0|0.0|0.26||||||||0.26|0.00|
91656190|NCT00755196|183205607|SUPERIORITY_OR_OTHER|||||||0.23|||||||2-sided sign test|||||||0.23
91711891|NCT00472732|183315162|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This p-value is adjusted for family wise error rate correction.|t-test, 2 sided|||Two-way between-group t-tests restricted to the prefrontal cortex were performed to compare activation during for the 2-Back\> 1-Back contrast between OTCD patients and controls.||||<0.05
91656191|NCT01604850|183205611|SUPERIORITY_OR_OTHER||Proportion difference|-22.4|||<|0.001|TWO_SIDED|95.0|-34.4|-10.3||P-value is from the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization stratification factor (ie, presence/absence of cirrhosis, genotype 2 or 3).|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 100 subjects in each group would provide over 97% power to detect at least 20% improvement in SVR12 rate from the assumed null rate of 25% using 2-sided exact 1-sample binomial test at significance level of 0.025.||-10.3|-34.4|< 0.001
91711892|NCT00472732|183315163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis predicted that fractional anisotropy, a marker of white matter integrity, would be the same for OTCD patients as for controls.||||<0.001
91711893|NCT04846270|183315164|OTHER|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of manual checks has been reduced.||"POWER is a single arm investigation with cross-over design. Each participating subject will use the study device and act as its own control.~The null hypothesis (H0) is that there is no difference in the mean number of checks performed during the investigation week compared to the baseline week.~The alternate hypothesis (H1) is that there is a reduction in the mean number of checks performed during the investigation week compared to the baseline week."||||0.0006
91656192|NCT01703832|183205617|SUPERIORITY_OR_OTHER|||||||0.1233||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.1233
91656193|NCT01703832|183205618|SUPERIORITY_OR_OTHER|||||||0.5153||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.5153
91656194|NCT00243932|183205630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0|||||futility (non-superiority)|||Null hypothesis: 2,700mg CoQ10 is at least 20% superior to placebo.||||0.14
91656195|NCT01458405|183205637|SUPERIORITY|||||||0.6453||||||Repeated measures multivariable linear regression with Baseline as a covariate and unstructured covariance.|Regression, Linear|||||||0.6453
91656196|NCT01193608|183205731|SUPERIORITY_OR_OTHER||Mean change|113.53||||0.599|TWO_SIDED|80.0|-170.3|397.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||397.35|-170.30|0.599
91711894|NCT04846270|183315166|OTHER|||||||0.0051|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of leakages had been reduced.||||||0.0051
91711895|NCT04846270|183315169|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of fecal incidents had been reduced.||||||0.76
91656197|NCT01193608|183205733|SUPERIORITY_OR_OTHER||Mean change|48.85||||0.297|TWO_SIDED|80.0|-11.79|109.48|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||109.48|-11.79|0.297
91656198|NCT01193608|183205735|SUPERIORITY_OR_OTHER||Mean change|-15.26||||0.6|TWO_SIDED|80.0|-53.54|23.02|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||23.02|-53.54|0.600
91656199|NCT01193608|183205737|SUPERIORITY_OR_OTHER||Mean change|1.23||||0.603|TWO_SIDED|80.0|-1.89|4.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||4.35|-1.89|0.603
91656200|NCT01249664|183205745|SUPERIORITY_OR_OTHER||Difference in least square means|14.1|||<|0.0001|TWO_SIDED|95.0|10.8|17.4||No adjustment on P value, this is for the primary efficacy analysis.|ANCOVA|ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.||17.4|10.8|<0.0001
91711896|NCT02915159|183315174|SUPERIORITY|||||||0.4421|||||||longitudinal repeated measures analysis|||||||0.4421
91711897|NCT02915159|183315175|SUPERIORITY|||||||0.3367|||||||longitudinal repeated measures analysis|||||||0.3367
91711898|NCT02915159|183315176|SUPERIORITY|||||||0.5841|||||||longitudinal repeated measures analysis|||||||.5841
91711899|NCT02418234|183315217|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91791345|NCT03720652|183460429|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.18|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.18
91711900|NCT02418234|183315218|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91656201|NCT01249664|183205746|SUPERIORITY_OR_OTHER||CMH adjusted difference|29.2||||0.0001|TWO_SIDED|95.0|14.4|44.0||No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.|Cochran-Mantel-Haenszel||A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.|Null hypothesis of difference of Eylea minus Sham of 0 was tested.||44.0|14.4|0.0001
91656202|NCT01249664|183205747|SUPERIORITY_OR_OTHER||Difference in least square means|13.1|||<|0.0001|TWO_SIDED|95.0|9.4|16.7|||ANCOVA|||||16.7|9.4|<0.0001
91656203|NCT01249664|183205748|SUPERIORITY_OR_OTHER||CMH adjusted difference|50.5|||<|0.001|TWO_SIDED|95.0|35.0|66.0|||Cochran-Mantel-Haenszel|||||66.0|35.0|<0.001
91656204|NCT01249664|183205749|SUPERIORITY_OR_OTHER||CMH adjusted difference|64.0|||<|0.001|TWO_SIDED|95.0|47.8|80.3|||Cochran-Mantel-Haenszel|||||80.3|47.8|<0.001
91656205|NCT01249664|183205750|SUPERIORITY_OR_OTHER||CMH adjusted difference|21.0||||0.0308|TWO_SIDED|95.0|1.9|40.1|||Cochran-Mantel-Haenszel|||||40.1|1.9|0.0308
91656206|NCT01249664|183205751|SUPERIORITY_OR_OTHER||CMH adjusted difference|27.0||||0.0075|TWO_SIDED|95.0|7.2|46.8|||Cochran-Mantel-Haenszel|||||46.8|7.2|0.0075
91791346|NCT03720652|183460429|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
91656207|NCT01249664|183205752|SUPERIORITY_OR_OTHER||CMH adjusted difference|42.7|||<|0.0001|TWO_SIDED|95.0|23.7|61.6|||Cochran-Mantel-Haenszel|||||61.6|23.7|<.0001
91656208|NCT01249664|183205753|SUPERIORITY_OR_OTHER||CMH adjusted difference|-6.5||||0.1478|TWO_SIDED|95.0|-15.2|2.3|||Cochran-Mantel-Haenszel|||||2.3|-15.2|0.1478
91656209|NCT01249664|183205754|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.8||||0.0006|TWO_SIDED|95.0|-40.6|-11.0|||Cochran-Mantel-Haenszel|||||-11.0|-40.6|0.0006
91656210|NCT01249664|183205755|SUPERIORITY_OR_OTHER||CMH adjusted difference|-32.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-16.3|||Cochran-Mantel-Haenszel|||||-16.3|-48.1|<0.0001
91656211|NCT01249664|183205756|SUPERIORITY_OR_OTHER||CMH adjusted difference|-5.3||||0.2446|TWO_SIDED|95.0|-14.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|-14.4|0.2446
91656212|NCT01249664|183205757|SUPERIORITY_OR_OTHER||CMH adjusted difference|-21.5||||0.0035|TWO_SIDED|95.0|-35.9|-7.0|||Cochran-Mantel-Haenszel|||||-7.0|-35.9|0.0035
91656213|NCT01249664|183205758|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.7||||0.0012|TWO_SIDED|95.0|-41.3|-10.1|||Cochran-Mantel-Haenszel|||||-10.1|-41.3|0.0012
91656214|NCT01249664|183205759|SUPERIORITY_OR_OTHER||Difference in least square means|-77.9|||<|0.0001|TWO_SIDED|95.0|-108.9|-46.9|||ANCOVA|||||-46.9|-108.9|<0.0001
91656215|NCT01249664|183205760|SUPERIORITY_OR_OTHER||Difference in least square means|-29.3||||0.065|TWO_SIDED|95.0|-60.4|1.8|||ANCOVA|||||1.8|-60.4|0.0650
91656216|NCT01249664|183205761|SUPERIORITY_OR_OTHER||Difference in least square means|-0.4808|||<|0.0001|TWO_SIDED|95.0|-0.599|-0.3626|||ANCOVA|||||-0.3626|-0.5990|<0.0001
91656217|NCT01249664|183205762|SUPERIORITY_OR_OTHER||Difference in least square means|-0.1346||||0.0256|TWO_SIDED|95.0|-0.2525|-0.0167|||ANCOVA|||||-0.0167|-0.2525|0.0256
91656218|NCT01249664|183205763|SUPERIORITY_OR_OTHER||Difference in least square means|-0.0045||||0.869|TWO_SIDED|95.0|-0.0579|0.049|||ANCOVA|||||0.0490|-0.0579|0.8690
91656219|NCT01249664|183205764|SUPERIORITY_OR_OTHER||Difference of least square means|5.21||||0.0104|TWO_SIDED|95.0|1.25|9.18|||ANCOVA|||||9.18|1.25|0.0104
91656220|NCT01249664|183205766|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6648|||<|0.0001|TWO_SIDED|95.0|-0.8056|-0.5239|||ANCOVA|||||-0.5239|-0.8056|<0.0001
91656221|NCT02674334|183205817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|0.83||0.165|TWO_SIDED|95.0|-0.49|2.82||P-values were not adjusted for multiple inferences|ANOVA|Continuous responses were tested using RCB ANOVA.||||2.82|-.49|0.165
91656222|NCT00235456|183205828|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.38|0.98|||Chi-squared|||||0.98|0.38|0.04
91656223|NCT00235456|183205829|SUPERIORITY_OR_OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
91656224|NCT00235456|183205830|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
91656225|NCT00235456|183205831|SUPERIORITY_OR_OTHER|||||||0.57|||||||t-test, 2 sided|||||||0.57
91656226|NCT00235456|183205832|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
91656227|NCT00235456|183205833|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
91656228|NCT00860405|183205836|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.|Ratio of LS-means|0.98|||||TWO_SIDED|95.0|0.84|1.16||Null hypothesis tested by calculating a 2-sided 95% CI for ratio of LS-means μVoluven/μHSA based on ANOVA incl.treatment+centre as effects. If 95% CI was within equivalence range(0.55, 1.82), significant equivalence was concluded (Type I error: 2.5%)|ANOVA|Primary endpoint specified + analysed for PP and ITT population. Confirmatory analysis based on PP population only, no adjustment for multiplicity.|Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%|The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 \< μVoluven/μHSA \< 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.||1.16|0.84|
91656229|NCT00864097|183205845|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.039|TWO_SIDED|95.0|-0.81|-0.02|||ANCOVA|||LS means were estimated from the corresponding analysis of covariance (ANCOVA) model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.81|0.039
91656230|NCT00864097|183205845|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.011
91656231|NCT00864097|183205845|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.2||0.005|TWO_SIDED|95.0|-0.97|-0.17|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.17|-0.97|0.005
91656232|NCT00864097|183205846|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.010
91656233|NCT00864097|183205846|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.03|-0.23|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.23|-1.03|0.002
91711901|NCT04534517|183315219|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points|Mean Estimate|58.6|STANDARD_DEVIATION|3.26|||TWO_SIDED|95.0|52.3|64.9|||Bayesian multivariate random-effects||Included Hyperope group only|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||64.9|52.3|
91656234|NCT00864097|183205846|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.30|-1.10|<0.001
91656235|NCT00864097|183205847|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.32|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.32|0.022
91656236|NCT00864097|183205847|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.020
91656237|NCT00864097|183205847|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.09|-0.40|0.002
91656238|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.957|TWO_SIDED|95.0|-0.32|0.34|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.34|-0.32|0.957
91656239|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.899|TWO_SIDED|95.0|-0.31|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.31|0.899
91656240|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.17||0.022|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.72|0.06|0.022
91656241|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.052|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.00|-0.70|0.052
91656242|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.34|-1.05|<0.001
91711902|NCT04534517|183315219|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for Myopes|Mean Estimate|63.8|STANDARD_DEVIATION|2.97|||TWO_SIDED|95.0|57.9|69.6|||Bayesian multivariate random-effects||Included myope group only.|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||69.6|57.9|
91656243|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|-0.84|-0.13|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.13|-0.84|0.008
91656244|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.058|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.72|0.058
91656245|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.32|-1.05|<0.001
91656246|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.12|-0.38|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.38|-1.12|<0.001
91791347|NCT03720652|183460429|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.13|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.13
91656247|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.91|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.91|0.007
91615352|NCT00905307|183124039|SUPERIORITY_OR_OTHER||Treatment difference|3.25||||0.1819|TWO_SIDED|95.0|-1.53|8.03|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||8.03|-1.53|0.1819
91615353|NCT00905307|183124040|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.0685|TWO_SIDED|95.0|-0.03|0.79|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in CGI-S score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.79|-0.03|0.0685
91615354|NCT00905307|183124040|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0989|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.05|-0.60|0.0989
91615355|NCT00905307|183124040|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8006|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.28|-0.37|0.8006
91615356|NCT00905307|183124040|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0898|TWO_SIDED|95.0|-0.6|0.04|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.04|-0.60|0.0898
91615357|NCT00905307|183124040|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.2851|TWO_SIDED|95.0|-0.59|0.18|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.18|-0.59|0.2851
91615358|NCT00905307|183124041|SUPERIORITY_OR_OTHER|||||||0.4008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.4008
91615359|NCT00905307|183124041|SUPERIORITY_OR_OTHER|||||||0.1117|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.1117
91615360|NCT00905307|183124041|SUPERIORITY_OR_OTHER|||||||0.2739|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.2739
91615361|NCT00905307|183124041|SUPERIORITY_OR_OTHER|||||||0.1045|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1045
91615362|NCT00905307|183124041|SUPERIORITY_OR_OTHER|||||||0.1149|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1149
91615363|NCT00905307|183124042|SUPERIORITY_OR_OTHER||Relative Risk|0.89||||0.62|TWO_SIDED|95.0|0.57|1.4|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.40|0.57|0.6200
91615364|NCT00905307|183124042|SUPERIORITY_OR_OTHER||Relative Risk|1.19||||0.1501|TWO_SIDED|95.0|0.95|1.48|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.48|0.95|0.1501
91656248|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.41|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.41|-1.18|<0.001
91656249|NCT00864097|183205848|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.28|-1.05|<0.001
91615365|NCT00905307|183124042|SUPERIORITY_OR_OTHER||Relative Risk|0.91||||0.5271|TWO_SIDED|95.0|0.66|1.25|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.25|0.66|0.5271
91615366|NCT00905307|183124042|SUPERIORITY_OR_OTHER||Relative Risk|1.02||||0.867|TWO_SIDED|95.0|0.78|1.34|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.34|0.78|0.8670
91615367|NCT00905307|183124042|SUPERIORITY_OR_OTHER||Relative Risk|1.15||||0.3892|TWO_SIDED|95.0|0.85|1.56|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.56|0.85|0.3892
91615368|NCT00905307|183124043|SUPERIORITY_OR_OTHER||Relative risk|1.06||||0.854|TWO_SIDED|95.0|0.59|1.88||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.88|0.59|0.8540
91615369|NCT00905307|183124043|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.4492|TWO_SIDED|95.0|0.49|1.38||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.38|0.49|0.4492
91656250|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.15||0.754|TWO_SIDED|95.0|-0.25|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.25|0.754
91656251|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.706|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.25|-0.36|0.706
91656252|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.266|TWO_SIDED|95.0|-0.13|0.48|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.48|-0.13|0.266
91656253|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.195|TWO_SIDED|95.0|-0.58|0.12|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.12|-0.58|0.195
91656254|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.07|-0.36|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.36|-1.07|<0.001
91711903|NCT04534517|183315220|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.10 logMAR for Distance|Mean estimate|-0.09|STANDARD_DEVIATION|0.0172|||TWO_SIDED|95.0|-0.125|-0.057|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.125|
91615370|NCT00905307|183124043|SUPERIORITY_OR_OTHER||Relative Risk|0.67||||0.1854|TWO_SIDED|95.0|0.36|1.23||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.23|0.36|0.1854
91615371|NCT00905307|183124043|SUPERIORITY_OR_OTHER||Relative Risk|0.61||||0.0946|TWO_SIDED|95.0|0.33|1.1||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.10|0.33|0.0946
91615372|NCT00905307|183124043|SUPERIORITY_OR_OTHER||Relative Risk|0.63||||0.2133||95.0|0.3|1.34||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.34|0.30|0.2133
91615373|NCT03015610|183124058|SUPERIORITY|||||||0.8716|||||||Wilcoxon (Mann-Whitney)|||||||0.8716
91615374|NCT03015610|183124059|SUPERIORITY|||||||0.2471|||||||Wilcoxon (Mann-Whitney)|||||||0.2471
91656255|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.019|TWO_SIDED|95.0|-0.78|-0.07|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.78|0.019
91656256|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.126|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.08|-0.64|0.126
91656257|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.37|-1.10|<0.001
91656258|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-0.98|0.001
91656259|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.90|0.007
91656260|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.44|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.44|-1.21|<0.001
91656261|NCT00864097|183205849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.02|-0.25|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-1.02|0.001
91656262|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.2|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.05|-0.22|0.200
91711904|NCT04534517|183315220|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate|Mean Estimate|-0.057|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|-0.091|-0.024|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.024|-0.091|
91656263|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.754|TWO_SIDED|95.0|-0.15|0.11|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.11|-0.15|0.754
91656264|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.449|TWO_SIDED|95.0|-0.08|0.18|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.18|-0.08|0.449
91656265|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.27|0.062
91656266|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.36|-0.08|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.08|-0.36|0.002
91656267|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.30|0.026
91656268|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.31|-0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.31|0.032
91656269|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.19|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.19|-0.48|<0.001
91656270|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.16|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.16|-0.45|<0.001
91656271|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.3|-0.01|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.30|0.038
91711905|NCT04534517|183315220|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near|Mean Estimate|0.066|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|0.031|0.098|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||0.098|0.031|
91711906|NCT04534517|183315221|SUPERIORITY|A superiority margin of 5% was used. Upper limit of 95% credible interval was compared to 5%.|Mean Proportion|0.001|STANDARD_DEVIATION|0.0012|||TWO_SIDED|95.0|0.0|0.004|||Bayesian beta-binomial model|Correlated Binary Data||||0.004|0.000|
91711907|NCT04534517|183315222|SUPERIORITY|A superiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Proportion|0.005|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|0.0|0.018|||Bayesian beta-binomial model|Correlated Binary Data||||0.018|0.000|
91711908|NCT04534517|183315223|SUPERIORITY|A superiority margin of 90% was used. Lower limit of the 95% credible interval was compared to 90%|Mean Proportion|0.992|STANDARD_DEVIATION|0.0072|||TWO_SIDED|95.0|0.973|0.999|||Bayesian beta-binomial model|Correlated Binary Data||||0.999|0.973|
91711909|NCT02121795|183315227|NON_INFERIORITY|Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.|Percentage difference|1.3||||0.5|TWO_SIDED|95.002|-2.5|5.1|||Cochran-Mantel-Haenszel|P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.|Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.|||5.1|-2.5|0.5
91711910|NCT00823264|183315237|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
91615375|NCT03015610|183124060|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91615376|NCT03015610|183124061|SUPERIORITY|||||||0.2765|||||||Wilcoxon (Mann-Whitney)|||||||0.2765
91615377|NCT03015610|183124062|SUPERIORITY||Risk Ratio (RR)|2.32||||0.191|TWO_SIDED|95.0|0.66|8.2|||Negative binomial regression|||||8.20|0.66|0.191
91615378|NCT03015610|183124063|SUPERIORITY||Risk Ratio (RR)|0.53||||0.0435|TWO_SIDED|95.0|0.29|0.98|||Negative binomial regression|||||0.98|0.29|0.0435
91615379|NCT03015610|183124064|SUPERIORITY|||||||0.3808|||||||Wilcoxon (Mann-Whitney)|||||||0.3808
91615380|NCT00358917|183124079|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (once daily \[QD\] minus twice daily \[BID\], based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|Diff. in Percentage of Subj. Responding|3.5||||0.413||95.0|-4.5|11.5|||normal approx. to binomial distribution|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||11.5|-4.5|0.413
91615381|NCT00358917|183124080|SUPERIORITY_OR_OTHER||Diff. in Percentage of Subj. Responding|3.8||||0.389||95.0|-4.3|11.9|||normal approx. to binomial distribution|||||11.9|-4.3|0.389
91615382|NCT00358917|183124081|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANOVA|||||||0.281
91615383|NCT00358917|183124083|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Fisher Exact|||||||0.222
91615384|NCT01417780|183124112|OTHER|||||||0.016|||||||ANOVA|||||||0.016
91615385|NCT01417780|183124113|OTHER|||||||0.019|||||||Chi-squared|||The null hypothesis was that the frequency of Day 14 SOFA score less than or equal to 1 was not different among treatment groups.||||0.019
91615386|NCT01417780|183124114|OTHER|||||||0.11||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.11
91615387|NCT01417780|183124115|OTHER|||||||0.18||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.18
91615388|NCT01417780|183124116|OTHER|||||||0.19||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.19
91615389|NCT02086565|183124117|SUPERIORITY||Group differences in expected 12 month c|-0.21|||||TWO_SIDED|95.0|-0.56|0.15||||||||0.15|-0.56|
91615390|NCT02086565|183124118|SUPERIORITY||Group differences in expected 12 month c|0.19|||||TWO_SIDED|95.0|-0.27|0.68|||||Estimation parameter: Other. Group differences in expected 12 month change from baseline|||0.68|-0.27|
91615391|NCT02086565|183124119|SUPERIORITY||Group differences in expected 12 month c|-0.6|||||TWO_SIDED|95.0|-2.21|0.97||||||||0.97|-2.21|
91615392|NCT02086565|183124120|SUPERIORITY||Group differences in expected 12 month c|-0.53|||||TWO_SIDED|95.0|-1.08|-0.24||||||||-0.24|-1.08|
91615393|NCT02086565|183124121|SUPERIORITY||Group differences in expected 12 month c|-0.09|||||TWO_SIDED|95.0|-0.24|0.06||||||||0.06|-0.24|
91615394|NCT01757704|183124124|SUPERIORITY_OR_OTHER||Median Difference (Net)|56.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91615395|NCT00325442|183124129|SUPERIORITY_OR_OTHER||Hodges-Lehmann|11.0||||0.072|TWO_SIDED|95.0|0.0|22.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||22|0|0.072
91615396|NCT00325442|183124130|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.062|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Change in Borg dyspnea score from Baseline to Week 16||0.0|-1.0|0.062
91615397|NCT00325442|183124131|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Fisher Exact|||||||0.491
91615398|NCT00325442|183124132|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.011|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||Change in dyspnea-fatigue index from Baseline to Week 16||1.0|0.0|0.011
91615399|NCT00325442|183124134|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|13.0||||0.015|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|||Change in 6MWD from Baseline to Week 12||23.0|3.0|0.015
91615400|NCT00325442|183124135|SUPERIORITY_OR_OTHER||Hodges-Lehmann|9.0||||0.051|TWO_SIDED|95.0|0.0|18.0|||ANCOVA|||Change in 6MWD from Baseline to Week 8||18.0|0.0|0.051
91615401|NCT00325442|183124136|SUPERIORITY_OR_OTHER||Hodges-Lehmann ( H-L)|4.0||||0.238|TWO_SIDED|95.0|-2.4|12.0|||ANCOVA|||Change in 6MWD from Baseline to Week 4||12.0|-2.4|0.238
91615402|NCT00325442|183124137|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|24.0||||0.121|TWO_SIDED|95.0|0.0|45.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||45|0|0.121
91615403|NCT00325442|183124138|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|15.0||||0.069|TWO_SIDED|95.0|-7.0|41.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||41|-7|0.069
91615404|NCT00325442|183124139|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|4.0||||0.889|TWO_SIDED|95.0|-15.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-15|0.889
91615405|NCT00325442|183124140|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.966|TWO_SIDED|95.0|-23.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-23|0.966
91615406|NCT00325442|183124142|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.853|TWO_SIDED|95.0|-16.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-16|0.853
91711911|NCT00856999|183315238|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
91615407|NCT00325442|183124143|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|7.0||||0.327|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||21|-7|0.327
91615408|NCT00325442|183124144|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|29.5||||0.085|TWO_SIDED|95.0|1.0|73.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||73|1|0.085
91615409|NCT00325442|183124145|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.615|TWO_SIDED|95.0|-12.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-12|0.615
91615410|NCT00325442|183124146|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|17.0||||0.23|TWO_SIDED|95.0|-6.0|40.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||40|-6|0.230
91615411|NCT00325442|183124147|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.209|TWO_SIDED|95.0|-6.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-6|0.209
91615412|NCT02650284|183124292|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.46||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.46
91615413|NCT02650284|183124292|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.23||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 6-week timepoint.||||0.23
91615414|NCT02650284|183124292|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.1||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 3-month timepoint.||||0.10
91615415|NCT02650284|183124292|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 12-month timepoint.||||0.98
91615416|NCT02650284|183124292|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.5||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 24-month timepoint.||||0.50
91615417|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.59||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D Index preoperatively between both groups.||||0.59
91615418|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 3-months between both groups.||||0.90
91615419|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 12-months between both groups.||||0.57
91615420|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.49||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 24-months between both groups.||||0.49
91615421|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means||||||0.65||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.65
91615422|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.3||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 3-months between both groups.||||0.30
91615423|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 12-months between both groups.||||0.06
91615424|NCT02650284|183124293|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.44||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 24-months between both groups.||||0.44
91615425|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.97||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest preoperatively between both groups.||||0.97
91615426|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.45||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 3-months between both groups.||||0.45
91711912|NCT00856999|183315239|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<.0004
91711913|NCT01065571|183315253|EQUIVALENCE|Non-parametric analysis of interval to relapse||||||0.046||||||result from log rank test|Log Rank|||Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.||||0.046
91615427|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.64||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 12-months between both groups.||||0.64
91615428|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.19||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 24-months between both groups.||||0.19
91615429|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation preoperatively between both groups.||||0.57
91615430|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 3-months between both groups.||||0.98
91615431|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.58||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 12-months between both groups.||||0.58
91615432|NCT02650284|183124294|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.16||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 24-months between both groups.||||0.16
91656272|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.37|-0.07|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.37|0.003
91656273|NCT00864097|183205850|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.016
91615433|NCT02650284|183124295|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.62||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score preoperatively between both groups.||||0.62
91615434|NCT02650284|183124295|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 3-months between both groups.||||0.06
91615435|NCT02650284|183124295|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.93||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 24-months between both groups.||||0.93
91615436|NCT02650284|183124296|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.57
91615437|NCT02650284|183124296|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.17||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 3-months between both groups.||||0.17
91615438|NCT02650284|183124296|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.8||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 12-months between both groups.||||0.80
91615439|NCT02650284|183124296|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 24-months between both groups.||||0.90
91615440|NCT02650284|183124298|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.81||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare length of hospital stay (number of nights) between both groups.||||0.81
91615441|NCT04525222|183124299|OTHER||Slope|0.42||||0.0088|TWO_SIDED|95.0|0.1|0.74|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||"Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all to very much. We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to test for differences between arms."||0.74|0.10|0.0088
91656274|NCT00320112|183205880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.004|TWO_SIDED|||||no differences between arms in baseline characteristics at \<0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.|Regression, Linear|we used STATA 11's xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.||||||0.004
91656275|NCT00320112|183205881|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||this is a priori design|Regression, Linear|||||||.91
91656276|NCT00320112|183205882|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Regression, Linear|||||||0.10
91656277|NCT00320112|183205883|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
91656278|NCT02899338|183205884|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using the analysis of variance (ANOVA)|Adjusted geometric mean ratio|101.71|STANDARD_ERROR_OF_MEAN|42.28|||TWO_SIDED|90.0|91.31|113.29|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual geometric coefficient of variation (gCV)|Comparison AI versus PFS||113.29|91.31|
91656279|NCT02899338|183205885|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|100.11|STANDARD_ERROR_OF_MEAN|23.72|||TWO_SIDED|90.0|94.17|106.43|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||106.43|94.17|
91656280|NCT02899338|183205886|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|103.19|STANDARD_ERROR_OF_MEAN|48.21|||TWO_SIDED|90.0|91.38|116.53|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||116.53|91.38|
91656281|NCT06179108|183205888|SUPERIORITY|||||||0.0009||||||Hochberg's step-down procedure was adopted to control type I error across the 50 and 75 mg arms.|Mixed Models Analysis|MMRM included treatment group, pooled study site, visit, visit by treatment interaction and baseline total PANSS score.||||||0.0009
91656282|NCT06179108|183205888|SUPERIORITY|||||||0.0022||||||Hochberg's step-down procedure was adopted to control type I error across the 50 and 75 mg arms.|Mixed Models Analysis|MMRM included treatment group, pooled study site, visit, visit by treatment interaction and baseline total PANSS score.||||||0.0022
91656283|NCT06179108|183205888|SUPERIORITY|||||||0.0017|||||||Mixed Models Analysis|MMRM included treatment group, pooled study site, visit, visit by treatment interaction and baseline total PANSS score.||||||.0017
91656284|NCT06179108|183205889|SUPERIORITY|||||||0.0008|||||||Mixed Models Analysis|MMRM included treatment group, pooled study site, visit, visit by treatment interaction and baseline CGI-S score.||||||0.0008
91711914|NCT01065571|183315254|SUPERIORITY|fecal calprotectin (micrograms/gm stool)||||||0.06|||||||t-test, 2 sided|||||||0.06
91656285|NCT06179108|183205889|SUPERIORITY|||||||0.0048|||||||Mixed Models Analysis|MMRM included treatment group, pooled study site, visit, visit by treatment interaction and baseline CGI-S score.||||||0.0048
91656286|NCT06179108|183205889|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|MMRM included treatment group, pooled study site, visit, visit by treatment interaction and baseline CGI-S score.||||||0.0026
91656287|NCT01199861|183205948|SUPERIORITY_OR_OTHER||Percent Inhibition|41.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
91656288|NCT01199861|183205948|SUPERIORITY_OR_OTHER||Percent Inhibition|-35.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
91656289|NCT01199861|183205948|SUPERIORITY_OR_OTHER||Percent Inhibition|44.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
91656290|NCT01199861|183205949|SUPERIORITY_OR_OTHER||Percent Inhibition|38.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
91656291|NCT01199861|183205949|SUPERIORITY_OR_OTHER||Percent Inhibition|-28.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
91656292|NCT01199861|183205949|SUPERIORITY_OR_OTHER||Percent Inhibition|48.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
91711915|NCT01065571|183315255|SUPERIORITY|||||||0.02||||||not adjusted for muliple comparisons, a priori threshold of 0.05|t-test, 2 sided|||paired t-test comparing baseline and value at end of participation||||0.02
91615442|NCT04525222|183124300|OTHER||Slope|2.92||||0.75|TWO_SIDED|95.0|-15.22|21.07|||Negative Binomial Regression|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||21.07|-15.22|0.75
91615443|NCT04525222|183124301|OTHER||Odds Ratio (OR)|1.33||||0.55|TWO_SIDED|95.0|0.5|3.48|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.48|0.5|0.55
91615444|NCT04525222|183124302|OTHER||Odds Ratio (OR)|1.63||||0.17|TWO_SIDED|95.0|0.8|3.32|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking \<20 Cigs/ \>=20 Cigs, Baseline Depression Severity PHQ-8\<5 / PHQ-8\>=5||||3.32|0.80|0.17
91615445|NCT04525222|183124303|OTHER||Odds Ratio (OR)|1.63||||0.25|TWO_SIDED|95.0|0.7|3.81|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.81|0.70|0.25
91615446|NCT04525222|183124304|OTHER||Odds Ratio (OR)|1.88||||0.07|TWO_SIDED|95.0|0.94|3.72||Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)|Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.72|0.94|0.07
91656293|NCT04817891|183205951|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91656294|NCT04817891|183205952|SUPERIORITY|||||||0.018||||||p value for the Ventral Attention Network (network segregation)|t-test, 2 sided|||||||0.018
91656295|NCT04817891|183205952|SUPERIORITY|||||||0.944||||||p value for the Cingulo Opercular Network (network segregation)|t-test, 2 sided|||||||0.944
91527420|NCT01003184|182930057|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.107||0.4967|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.28|-0.14|0.4967
91615447|NCT04525222|183124305|OTHER||Odds Ratio (OR)|2.42||||0.04|TWO_SIDED|95.0|1.0|5.85|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||5.85|1.00|0.04
91615448|NCT04525222|183124306|OTHER||Odds Ratio (OR)|1.47||||0.25|TWO_SIDED|95.0|0.75|2.89|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||2.89|0.75|0.25
91615449|NCT04525222|183124307|OTHER||Odds Ratio (OR)|1.78||||0.17|TWO_SIDED|95.0|0.77|4.12|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.12|0.77|0.17
91615450|NCT04525222|183124308|OTHER||Odds Ratio (OR)|1.91||||0.15|TWO_SIDED|95.0|0.77|4.73|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.73|0.77|0.15
91615451|NCT04525222|183124309|OTHER||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.41|3.86|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.86|0.41|0.68
91615452|NCT04525222|183124310|OTHER||Odds Ratio (OR)|1.63||||0.21|TWO_SIDED|95.0|0.75|3.46|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.46|0.75|0.21
91615453|NCT04525222|183124311|OTHER||Odds Ratio (OR)|1.63||||0.3|TWO_SIDED|95.0|0.63|4.19|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.19|0.63|0.30
91615454|NCT04525222|183124312|OTHER||Slope|-1.68||||0.0072|TWO_SIDED|95.0|-2.9|-0.46|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||-0.46|-2.90|.0072
91615455|NCT04525222|183124313|OTHER||Odds Ratio (OR)|1.829||||0.177|TWO_SIDED|95.0|0.77|4.344|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.344|0.770|0.1770
91615456|NCT04525222|183124314|OTHER||Slope|3.62||||0.0025|TWO_SIDED|95.0|1.28|5.95|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression, Baseline Activation Score||||5.95|1.28|0.0025
91615457|NCT00374907|183124320|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|18.5||||0.035|TWO_SIDED|95.0|1.3|38.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||38.7|1.3|0.0350
91615458|NCT00374907|183124321|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|27.9||||0.0204|TWO_SIDED|95.0|4.2|57.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||57.1|4.2|0.0204
91656296|NCT04817891|183205953|SUPERIORITY|||||||0.239|||||||t-test, 1 sided|||||||0.239
91656297|NCT04817891|183205954|SUPERIORITY|||||||0.168|||||||t-test, 1 sided|||||||0.168
91656298|NCT04533646|183205964|OTHER||Mean Difference (Net)|1.1|||<|0.01|TWO_SIDED||||||Means testing||||comparison of means test was performed|||<0.01
91656299|NCT04256421|183205966|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.3504|TWO_SIDED|95.0|0.89|1.38|||Log Rank|||Stratification factors were LDH (\> upper limit of normal \[ULN\] vs. \</= ULN) and Eastern Cooperative Oncology Group (ECOG; 0 vs. 1).||1.38|0.89|0.3504
91656300|NCT04256421|183205967|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.2859|TWO_SIDED|95.0|0.9|1.44|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.44|0.90|0.2859
91656301|NCT04256421|183205968|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.444|TWO_SIDED|95.0|0.89|1.31|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.31|0.89|0.4440
91711916|NCT04391179|183315266|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.027||0.24|TWO_SIDED|95.0|-0.089|0.023|||Mixed Models Analysis||Estimation represents log-scale difference between average daily change in D-Dimer for Dipyridamole patients minus placebo average daily change. Negative estimates indicate that D-Dimer levels decline faster in Dipyridamole versus placebo patients.|||.023|-.089|0.24
91711917|NCT04391179|183315267|SUPERIORITY||win ratio|1.0||||0.98|TWO_SIDED|97.8|0.78|1.29|||Mantel Haenszel||win ratio= (the probability of a win for the dipyridamole patient)/(probability of a win for the placebo patient)|A win ratio analysis of the hierarchical composite outcome requiring direct comparison of outcomes between each dipyridamole patient and placebo patient. The patient with the superior outcome is adjudicated the 'winner' and receives a +1 score, while the 'loser' scores -1.||1.29|0.78|.98
91615459|NCT02389946|183124343|NON_INFERIORITY|Non-inferiority of the 12-month TLF rate for the Orsiro stent vs. the Xience stent was assessed as the primary endpoint. The null hypothesis H0 was that the Orsiro stent would have a primary endpoint (12-month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis HA was that the Orsiro stent would have a 12-month TLF rate less than the Xience group rate plus the non-inferiority margin of 3.85%.|Posterior Probability of non-inferioriry|100.0|||||TWO_SIDED|||||||||Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.||||
91615460|NCT02389946|183124344|OTHER|||||||0.415|||||||Fisher Exact|||||||0.415
91615461|NCT01605396|183124353|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.565|TWO_SIDED|80.0|0.81|1.72|||Regression, Cox|||Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||1.72|0.81|0.565
91615462|NCT01605396|183124355|OTHER||Difference of Percentages|-10.0||||0.267|TWO_SIDED|95.0|-27.8|8.0|||Miettinen and Nurminen's Method|||Miettinen and Nurminen's method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.||8.0|-27.8|0.267
91615463|NCT01605396|183124356|OTHER||Hazard Ratio (HR)|1.38||||0.562|TWO_SIDED|95.0|0.46|4.13|||Regression, Cox|||HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||4.13|0.46|0.562
91656302|NCT04256421|183205969|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4205|TWO_SIDED|95.0|0.88|1.35|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.35|0.88|0.4205
91656303|NCT04256421|183205970|SUPERIORITY||Difference in Overall Response Rates|6.8||||0.1418|TWO_SIDED|95.0|-2.57|15.99|||Cochran-Mantel-Haenszel|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||15.99|-2.57|0.1418
91656304|NCT04256421|183205971|SUPERIORITY||Difference in Overall Response Rates|5.19||||0.2191|TWO_SIDED|95.0|-3.33|13.61|||Cochran-Mantel-Haenszel|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||13.61|-3.33|0.2191
91656305|NCT04256421|183205976|SUPERIORITY||Difference in Event Free Rate|-3.74||||0.458|TWO_SIDED|95.0|-13.6|6.13|||Z-test|||Month 12||6.13|-13.60|0.4580
91656306|NCT04256421|183205976|SUPERIORITY||Difference in Event Free Rate|-8.12||||0.0999|TWO_SIDED|95.0|-17.8|1.55|||Z-test|||Month 24||1.55|-17.80|0.0999
91656307|NCT04256421|183205977|SUPERIORITY||Difference in Event Free Rate|-3.02||||0.5059|TWO_SIDED|95.0|-11.92|5.88|||Z-test|||Month 12||5.88|-11.92|0.5059
91656308|NCT04256421|183205977|SUPERIORITY||Difference in Event Free Rate|-5.29||||0.2458|TWO_SIDED|95.0|-14.23|3.65|||Z-test|||Month 24||3.65|-14.23|0.2458
91656309|NCT04256421|183205978|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9819|TWO_SIDED|95.0|0.68|1.48|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.48|0.68|0.9819
91656310|NCT04256421|183205979|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5122|TWO_SIDED|95.0|0.81|1.55|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.55|0.81|0.5122
91656311|NCT04256421|183205980|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.3614|TWO_SIDED|95.0|0.81|1.79|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.79|0.81|0.3614
91656312|NCT04256421|183205981|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.1681|TWO_SIDED|95.0|0.9|1.84|||Log Rank|||Stratification factors were LDH (\> ULN vs. \</= ULN) and ECOG (0 vs. 1).||1.84|0.90|0.1681
91656313|NCT02424188|183206005|SUPERIORITY||Odds Ratio (OR)|5.9|||||TWO_SIDED|95.0|2.3|15.4||||||||15.4|2.3|
91656314|NCT02424188|183206006|SUPERIORITY||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|1.2|12.3||||||||12.3|1.2|
91656315|NCT02424188|183206007|SUPERIORITY||Odds Ratio (OR)|4.8|||||TWO_SIDED|95.0|1.3|17.5||||||6 month comparison||17.5|1.3|
91656316|NCT02424188|183206007|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|2.4|48.6||||||12 month||48.6|2.4|
91656317|NCT02424188|183206009|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||||||6 months||2.3|-1.7|
91656318|NCT02424188|183206009|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.5|4.7||||||18 months||4.7|-1.5|
91656319|NCT02424188|183206010|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.6|1.5||||||||1.5|-0.6|
91656320|NCT02424188|183206012|SUPERIORITY||Mean Difference (Net)|-16.2|||||TWO_SIDED|95.0|-30.2|-2.3||||||||-2.3|-30.2|
91656321|NCT00453362|183206032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.017|TWO_SIDED|95.0|0.11|0.87||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.||0.87|0.11|0.017
91656322|NCT00453362|183206034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.076|TWO_SIDED|95.0|0.06|1.42||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.||1.42|0.06|0.076
91711918|NCT04391179|183315268|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
91615464|NCT04598165|183124357|SUPERIORITY||Risk Ratio (RR)|1.25||||0.314|TWO_SIDED|95.0|0.81|1.92||The primary intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||1.92|0.81|0.314
91615465|NCT04598165|183124358|SUPERIORITY||Risk Ratio (RR)|1.36||||0.217|TWO_SIDED|95.0|0.84|2.21||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||2.21|0.84|0.217
91615466|NCT04598165|183124359|SUPERIORITY||Risk Ratio (RR)|1.04||||0.064|TWO_SIDED|95.0|1.0|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in early initiation of breast feeding assuming 80% uptake in controls.||1.08|1.00|0.064
91615467|NCT04598165|183124360|SUPERIORITY||Risk Ratio (RR)|0.99||||0.363|TWO_SIDED|95.0|0.98|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in exclusive breast feeding assuming 80% uptake in controls.||1.01|0.98|0.363
91615468|NCT04598165|183124361|SUPERIORITY||Risk Ratio (RR)|1.01||||0.093|TWO_SIDED|95.0|1.0|1.02||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.02|1.00|0.093
91615469|NCT04598165|183124362|SUPERIORITY||Risk Ratio (RR)|1.03||||0.353|TWO_SIDED|95.0|0.97|1.09||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.09|0.97|0.353
91615470|NCT04598165|183124363|SUPERIORITY||Risk Ratio (RR)|1.14||||0.751|TWO_SIDED|95.0|0.5|2.61||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.53 in provision of Kangaroo Mother Care assuming 25% in controls.||2.61|0.50|0.751
91615471|NCT04598165|183124364|SUPERIORITY||Risk Ratio (RR)|1.0||||0.431|TWO_SIDED|95.0|1.0|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.04 in number of danger signs correctly named assuming median of 3 in controls.||1.01|1.00|0.431
91711919|NCT04391179|183315269|SUPERIORITY|||||||0.09|||||||Log Rank|||||||.09
91711920|NCT04391179|183315270|SUPERIORITY||Mean Difference (Net)|0.29||||0.36|TWO_SIDED|95.0|0.02|3.94|||regression, negative binomial||estimated ratio of days on mechanical ventilation for dipyridamole and placebo|||3.94|0.02|0.36
91711921|NCT04391179|183315271|SUPERIORITY||Odds Ratio (OR)|1.04||||0.94|TWO_SIDED|95.0|0.43|2.51|||Regression, Logistic||Odds of a 50 point drop in the dipyridamole group relative to the placebo group.|||2.51|0.43|.94
91711922|NCT04391179|183315272|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||.95
91711923|NCT02754518|183315289|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
91711924|NCT02754518|183315290|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
91711925|NCT02754518|183315291|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
91711926|NCT02754518|183315292|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
91791348|NCT03720652|183460430|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.7|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.70
91615472|NCT04598165|183124365|SUPERIORITY||Risk Ratio (RR)|1.03||||0.321|TWO_SIDED|95.0|0.98|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in appropriate care seeking assuming 1 clinic visit in the 6-weeks postpartum for controls.||1.08|0.98|0.321
91615473|NCT04598165|183124366|SUPERIORITY||Risk Ratio (RR)|1.01||||0.65|TWO_SIDED|95.0|0.98|1.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 0.76 in elevated depression symptoms assuming 19% in controls.||1.04|0.98|0.650
91615474|NCT04598165|183124367|SUPERIORITY||Coefficient|0.09||||0.071|TWO_SIDED|95.0|-0.007|0.18||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.18|-0.007|0.071
91615475|NCT04598165|183124368|SUPERIORITY||Coefficient|0.02||||0.19|TWO_SIDED|95.0|-0.01|0.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.04|-0.01|0.190
91615476|NCT00426751|183124375|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.|Median Difference (Final Values)|2.1||||||90.0|-8.5|12.8||||||||12.8|-8.5|
91615477|NCT00426751|183124376|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.|Mean Difference (Final Values)|6.8||||||95.0|-3.0|16.6|||||Analysis based on the ITT population confirmed the results observed in the PP population.|||16.6|-3.0|
91615478|NCT01721408|183124395|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.|Difference in percentage|-6.7||||0.0008|TWO_SIDED|95.0|-12.0|-1.4|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||-1.4|-12.0|0.0008
91615479|NCT01721408|183124396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
91615480|NCT01721408|183124397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
91656323|NCT00453362|183206036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17||||0.008|TWO_SIDED|95.0|0.04|0.73||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.||0.73|0.04|0.008
91656324|NCT00453362|183206037|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank|||The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.||||0.049
91656325|NCT00453362|183206038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.073|TWO_SIDED|95.0|0.11|1.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.||1.16|0.11|0.073
91711927|NCT02754518|183315293|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
91711928|NCT02754518|183315294|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
91711929|NCT02754518|183315295|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
91615481|NCT01721408|183124399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-6.0||||0.004|TWO_SIDED|95.0|-12.8|0.8|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||0.8|-12.8|0.0040
91615482|NCT04160468|183124400|SUPERIORITY||Risk Difference (RD)|-10.6||||0.392|TWO_SIDED|95.0|-33.6|12.4|||Fisher Exact|||||12.4|-33.6|0.392
91615483|NCT06018350|183124465|OTHER|||||||0.002|||||||McNemar|||||||0.002
91615484|NCT01096446|183124469|NON_INFERIORITY_OR_EQUIVALENCE|The Chi Square satistical calculation was used for analysis.||||||0.011|TWO_SIDED|95.0|||||Chi-squared|||Four infants(44%)in the control group developed hypertriglyceridemia (\>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (\>200 mg/dl) during the first week of life.||||0.011
91615485|NCT02279524|183124478|SUPERIORITY||Difference in least square means|-3.09||||0.0655|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0655
91615486|NCT02279524|183124478|SUPERIORITY||Difference in least square means|-3.32||||0.045|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0450
91615487|NCT02279524|183124479|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0514|TWO_SIDED|95.0|0.99|22.66|||Regression, Logistic|The method used was a Baseline Adjusted Logistic Regression||||22.66|0.99|0.0514
91615488|NCT02279524|183124479|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4955|TWO_SIDED|95.0|0.33|9.61|||Regression, Logistic|||||9.61|0.33|0.4955
91615489|NCT02279524|183124480|SUPERIORITY||Odds Ratio (OR)|1.88||||0.211|TWO_SIDED|95.0|0.7|5.04|||Regression, Logistic|||||5.04|0.70|0.2110
91615490|NCT02279524|183124480|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8425|TWO_SIDED|95.0|0.4|3.05|||Regression, Logistic|||||3.05|0.40|0.8425
91615491|NCT02279524|183124481|SUPERIORITY||Difference in least square means|-29.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.0001
91615492|NCT02279524|183124481|SUPERIORITY||Difference in least square means|-23.8|STANDARD_ERROR_OF_MEAN|6.3||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
91615493|NCT02279524|183124482|SUPERIORITY||Difference in least square means|-0.447||||0.0008|TWO_SIDED|95.0|-0.7063|-0.1877|||Mixed Models Analysis|||||-0.1877|-0.7063|0.0008
91615494|NCT02279524|183124482|SUPERIORITY||Difference in least square means|-0.362||||0.0061|TWO_SIDED|95.0|-0.6196|-0.1043|||Mixed Models Analysis|||||-0.1043|-0.6196|0.0061
91615495|NCT02279524|183124483|SUPERIORITY||Difference in least square means|-17.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91615496|NCT02279524|183124483|SUPERIORITY||Difference in least square means|-13.9|STANDARD_ERROR_OF_MEAN|4.2||0.0011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0011
91615497|NCT02279524|183124484|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0279|TWO_SIDED|95.0|1.11|6.88|||Mixed Models Analysis|||||6.88|1.11|0.0279
91615498|NCT02279524|183124484|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0878|TWO_SIDED|95.0|0.89|5.46|||Regression, Logistic|||||5.46|0.89|0.0878
91615499|NCT02279524|183124485|SUPERIORITY||Odds Ratio (OR)|0.14||||0.1008|TWO_SIDED|95.0|0.01|1.46|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||1.46|0.01|0.1008
91615500|NCT02279524|183124485|SUPERIORITY||Odds Ratio (OR)|0.63||||0.5693|TWO_SIDED|95.0|0.13|3.05|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||3.05|0.13|0.5693
91656326|NCT00453362|183206041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.618|TWO_SIDED|95.0|0.14|3.21||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.||3.21|0.14|0.618
91656327|NCT00453362|183206042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.163|TWO_SIDED|95.0|0.09|1.57||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.||1.57|0.09|0.163
91656328|NCT00453362|183206043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.327|TWO_SIDED|95.0|0.04|3.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Progressive Disease.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.||3.16|0.04|0.327
91656329|NCT04885296|183206045|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|95.0|-2.2|3.0|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||3.0|-2.2|
91656330|NCT04885296|183206046|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|95.0|-4.0|2.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||2.3|-4.0|
91711930|NCT02754518|183315296|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.|paired t-test|||0.13
91711931|NCT02754518|183315297|OTHER|||||||0.95||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.95
91711932|NCT02754518|183315298|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
91656331|NCT04885296|183206047|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-4.7|1.7|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||1.7|-4.7|
91656332|NCT01124149|183206074|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.76|3.87|||Regression, Logistic|||||3.87|1.76|<0.001
91656333|NCT01124149|183206075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.44|3.07|||Regression, Logistic|||||3.07|1.44|<0.001
91656334|NCT00977106|183206082|SUPERIORITY_OR_OTHER|||||||0.472|||||||Chi-squared|||||||0.472
91656335|NCT00977106|183206083|SUPERIORITY_OR_OTHER|||||||0.377||||||Between-group test (equal variances)|Student t-test|||Change at Week 1||||0.377
91656336|NCT00977106|183206083|SUPERIORITY_OR_OTHER|||||||0.276|||||||Student t-test|Between-group test (unequal variances)||Change at Week 4||||0.276
91656337|NCT00977106|183206085|SUPERIORITY_OR_OTHER|||||||0.502|||||||Student t-test|Between-group test (equal variances)||Change at Week 4||||0.502
91656338|NCT00977106|183206087|SUPERIORITY_OR_OTHER|||||||0.434||||||Between placebo and TCZ groups test (Equal Variances) at week 4|t-test, 1 sided|||||||0.434
91656339|NCT00977106|183206089|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.692
91656340|NCT00977106|183206089|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.019
91656341|NCT00977106|183206090|SUPERIORITY_OR_OTHER|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.137
91656342|NCT00977106|183206090|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.043
91656343|NCT01644500|183206134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||Mixed Models Analysis|||||-0.39|-0.76|<0.001
91656344|NCT01644500|183206134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||||-0.13|-0.50|<0.001
91656345|NCT01644500|183206135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|5.0|1.8|4.1||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||4.1|1.8|<0.001
91615501|NCT01441440|183124572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.031|TWO_SIDED|95.0|0.14|2.87||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.87|0.14|0.031
91656346|NCT01644500|183206135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.0|2.3||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||2.3|1.0|<0.001
91656347|NCT01644500|183206135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|1.8|4.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||4.5|1.8|<0.001
91656348|NCT01644500|183206135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.192|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||2.5|1.1|0.192
91656349|NCT01644500|183206136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.15|-0.51|||Mixed Models Analysis|||||-0.51|-1.15|<0.001
91656350|NCT01644500|183206136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38||||0.022|TWO_SIDED|95.0|-0.7|-0.05|||Mixed Models Analysis|||||-0.05|-0.70|0.022
91656351|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||-0.45|-0.89|<0.001
91615502|NCT01441440|183124572|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12||||0.106|TWO_SIDED|95.0|-0.24|2.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||2.48|-0.24|0.106
91615503|NCT01441440|183124573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.88||||0.008|TWO_SIDED|95.0|0.77|5.0||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||5.00|0.77|0.008
91615504|NCT01441440|183124573|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64||||0.014|TWO_SIDED|95.0|0.54|4.74||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||4.74|0.54|0.014
91656352|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.304|TWO_SIDED|95.0|-0.34|0.11||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||0.11|-0.34|0.304
91656353|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.8|-0.92||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.92|-1.80|<0.001
91656354|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.015|TWO_SIDED|95.0|-0.99|-0.11||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.11|-0.99|0.015
91615505|NCT01441440|183124574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.025|TWO_SIDED|95.0|0.03|0.49||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.49|0.03|0.025
91615506|NCT01441440|183124574|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.032|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.032
91656355|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.36||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||-0.36|-1.10|<0.001
91656356|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06||||0.74|TWO_SIDED|95.0|-0.43|0.31||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||0.31|-0.43|0.740
91656357|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.56|||<|0.001|TWO_SIDED|95.0|-1.99|-1.13||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-1.13|-1.99|<0.001
91656358|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.24|-0.39||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.39|-1.24|<0.001
91656359|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.0|-0.34||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||-0.34|-1.00|<0.001
91656360|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.638|TWO_SIDED|95.0|-0.41|0.25||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||0.25|-0.41|0.638
91656361|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.68|-0.87||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.87|-1.68|<0.001
91656362|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.03|TWO_SIDED|95.0|-0.85|-0.04||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.04|-0.85|0.030
91656363|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.19|||<|0.001|TWO_SIDED|95.0|-1.56|-0.82||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.82|-1.56|<0.001
91656364|NCT01644500|183206137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-1.03|-0.29||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.29|-1.03|<0.001
91656365|NCT01644500|183206138|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
91656366|NCT01644500|183206138|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
91656367|NCT01644500|183206138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.008
91656368|NCT01644500|183206138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.006
91656369|NCT01644500|183206139|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91656370|NCT01644500|183206139|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91656371|NCT01644500|183206140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.41|||<|0.001|TWO_SIDED|95.0|11.27|23.55|||ANCOVA|||Insulin HOMA2-%B||23.55|11.27|<0.001
91615507|NCT01441440|183124575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18||||0.004|TWO_SIDED|95.0|0.39|1.97||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||1.97|0.39|0.004
91615508|NCT01441440|183124575|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06||||0.008|TWO_SIDED|95.0|0.28|1.85||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.85|0.28|0.008
91615509|NCT01441440|183124576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.48|2.53||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.53|0.48|0.004
91615510|NCT01441440|183124576|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.137|TWO_SIDED|95.0|-0.25|1.79||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.79|-0.25|0.137
91615511|NCT01441440|183124577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.073|TWO_SIDED|95.0|-0.02|0.45||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.45|-0.02|0.073
91615512|NCT01441440|183124577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.034|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.034
91615513|NCT01993329|183124578|SUPERIORITY||Geometric means ratio|1.108||||0.616|TWO_SIDED|95.0|0.734|1.673|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.673|0.734|0.616
91615514|NCT01993329|183124578|SUPERIORITY||Geometric means ratio|1.016||||0.939|TWO_SIDED|95.0|0.673|1.534|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.534|0.673|0.939
91615515|NCT01993329|183124578|SUPERIORITY||Geometric means ratio|0.917||||0.671|TWO_SIDED|95.0|0.607|1.384|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.384|0.607|0.671
91615516|NCT01993329|183124579|SUPERIORITY||Mean Difference (Final Values)|-0.111||||0.066|TWO_SIDED|95.0|-0.23|0.008|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||0.008|-0.230|0.066
91615517|NCT01993329|183124579|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.843|TWO_SIDED|95.0|-0.131|0.107|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.107|-0.131|0.843
91615518|NCT01993329|183124579|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.098|TWO_SIDED|95.0|-0.218|0.02|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.020|-0.218|0.098
91615519|NCT04742907|183124619|SUPERIORITY||Cox Proportional Hazard|0.91||||0.767|TWO_SIDED|90.0|0.74|1.12||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: hazard ratio (HR) = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and confidence intervals (CIs) are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.12|0.74|0.767
91615520|NCT04742907|183124619|SUPERIORITY||Cox Proportional Hazard|1.17||||0.107|TWO_SIDED|90.0|0.95|1.44||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.44|0.95|0.107
91615521|NCT04742907|183124620|SUPERIORITY||Cox Proportional Hazard|0.9||||0.78|TWO_SIDED|90.0|0.71|1.13||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.13|0.71|0.780
91615522|NCT04742907|183124620|SUPERIORITY||Cox Proportional Hazard|1.06||||0.33|TWO_SIDED|90.0|0.84|1.34||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.34|0.84|0.330
91615523|NCT04742907|183124620|SUPERIORITY||Cox Proportional Hazard|0.9||||0.788|TWO_SIDED|90.0|0.73|1.11||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.11|0.73|0.788
91615524|NCT04742907|183124620|SUPERIORITY||Cox Proportional Hazard|1.22||||0.055|TWO_SIDED|90.0|0.99|1.51||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.51|0.99|0.055
91656372|NCT01644500|183206140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.92||||0.012|TWO_SIDED|95.0|1.78|14.06|||ANCOVA|||Insulin HOMA2%B||14.06|1.78|0.012
91656373|NCT01644500|183206140|SUPERIORITY||Mean Difference (Net)|16.44|||<|0.001|TWO_SIDED|95.0|11.81|21.06|||ANCOVA|||C-Peptide-Based HOMA2-%B||21.06|11.81|<0.001
91656374|NCT01644500|183206140|SUPERIORITY||Mean Difference (Net)|9.99|||<|0.001|TWO_SIDED|95.0|5.36|14.62|||ANCOVA|||C-Peptide-Based HOMA2-%B||14.62|5.36|<0.001
91615525|NCT04742907|183124620|SUPERIORITY||Cox Proportional Hazard|1.07||||0.306|TWO_SIDED|90.0|0.86|1.32||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.32|0.86|0.306
91615526|NCT04742907|183124620|SUPERIORITY||Cox Proportional Hazard|1.09||||0.243|TWO_SIDED|90.0|0.88|1.35||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.35|0.88|0.243
91615527|NCT04742907|183124621|SUPERIORITY||Cox Proportional Hazard|1.0||||0.489|TWO_SIDED|90.0|0.81|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.24|0.81|0.489
91615528|NCT04742907|183124621|SUPERIORITY||Cox Proportional Hazard|1.15||||0.138|TWO_SIDED|90.0|0.93|1.42||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.42|0.93|0.138
91615529|NCT04742907|183124621|SUPERIORITY||Cox Proportional Hazard|1.01||||0.473|TWO_SIDED|90.0|0.82|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.24|0.82|0.473
91615530|NCT04742907|183124621|SUPERIORITY||Cox Proportional Hazard|1.24||||0.045|TWO_SIDED|90.0|1.01|1.53||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.53|1.01|0.045
91615531|NCT04742907|183124622|SUPERIORITY|||||||0.923||||||P-value is from two-sample t-test comparing TU-100 15 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.923
91615532|NCT04742907|183124622|SUPERIORITY|||||||0.039||||||P-value is from two-sample t-test comparing TU-100 7.5 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.039
91615533|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|0.79||||0.434|TWO_SIDED|95.0|0.44|1.42||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.42|0.44|0.434
91615534|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|0.9||||0.71|TWO_SIDED|95.0|0.51|1.59||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.59|0.51|0.710
91615535|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|1.23||||0.41|TWO_SIDED|95.0|0.75|2.02||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Chi-squared||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.02|0.75|0.410
91656375|NCT01644500|183206141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.913|TWO_SIDED|95.0|-5.83|6.51|||ANCOVA|||Insulin-Based HOMA2%S||6.51|-5.83|0.913
91615536|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|1.7||||0.037|TWO_SIDED|95.0|1.03|2.81||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.81|1.03|0.037
91615537|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|0.84||||0.579|TWO_SIDED|95.0|0.46|1.55||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||1.55|0.46|0.579
91615538|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|0.63||||0.167|TWO_SIDED|95.0|0.33|1.21||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic|||For Day 3||1.21|0.33|0.167
91615539|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4|TWO_SIDED|95.0|0.21|1.86||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.86|0.21|0.400
91615540|NCT04742907|183124624|SUPERIORITY||Odds Ratio (OR)|0.28||||0.083|TWO_SIDED|95.0|0.07|1.18|||Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.18|0.07|0.083
91615541|NCT04742907|183124625|SUPERIORITY||Odds Ratio (OR)|1.33||||0.621|TWO_SIDED|95.0|0.43|4.14||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||4.14|0.43|0.621
91615542|NCT04742907|183124625|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.31|3.46||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||3.46|0.31|0.962
91656376|NCT01644500|183206141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.14||||0.318|TWO_SIDED|95.0|-9.3|3.03|||ANCOVA|||Insulin-Based HOMA2%S||3.03|-9.30|0.318
91656377|NCT01644500|183206141|SUPERIORITY||Mean Difference (Net)|-1.39||||0.576|TWO_SIDED|95.0|-6.27|3.49|||ANCOVA|||C-Peptide-Based HOMA2-%S||3.49|-6.27|0.576
91711933|NCT02754518|183315299|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
91711934|NCT02754518|183315300|OTHER|||||||0.65||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired T-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.65
91711935|NCT02754518|183315301|OTHER|||||||0.06||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.06
91711936|NCT02754518|183315302|OTHER|||||||0.76||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.76
91711937|NCT02754518|183315303|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Fisher Exact|||Primary outcome was presented at baseline and 1-year as frequency and percentages based upon the Shapiro-Wilks test of normality, and then analyzed with the Fisher exact test.||||0.07
91615543|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|1.16||||0.604|TWO_SIDED|95.0|0.66|2.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||2.05|0.66|0.604
91615544|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|1.12||||0.693|TWO_SIDED|95.0|0.63|1.99||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.99|0.63|0.693
91615545|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|1.8||||0.122|TWO_SIDED|95.0|0.85|3.78||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||3.78|0.85|0.122
91615546|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|0.78||||0.518|TWO_SIDED|95.0|0.36|1.67||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.67|0.36|0.518
91615547|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|1.45||||0.528|TWO_SIDED|95.0|0.46|4.53||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.53|0.46|0.528
91615548|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|1.27||||0.689|TWO_SIDED|95.0|0.4|4.07||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.07|0.40|0.689
91615549|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|0.68||||0.653|TWO_SIDED|95.0|0.12|3.7||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.70|0.12|0.653
91656378|NCT01644500|183206141|SUPERIORITY||Mean Difference (Net)|-6.79||||0.007|TWO_SIDED|95.0|-11.68|-1.89|||ANCOVA|||C-Peptide-Based HOMA2-%S||-1.89|-11.68|0.007
91711938|NCT02754518|183315304|OTHER|||||||0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.001
91615550|NCT04742907|183124627|SUPERIORITY||Odds Ratio (OR)|1.85||||0.452|TWO_SIDED|95.0|0.37|9.25||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||9.25|0.37|0.452
91656379|NCT01644500|183206144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.180
91656380|NCT01644500|183206144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.245
91656381|NCT01644500|183206144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.717
91656382|NCT01644500|183206144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.619
91656383|NCT01644500|183206145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91711939|NCT02754518|183315307|OTHER|||||||0.03||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.03
91615551|NCT04742907|183124628|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.359|TWO_SIDED|95.0|-1.8|0.6|||Mixed Models Analysis|||For Day 1, least square (LS) mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.6|-1.8|0.359
91615552|NCT04742907|183124628|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.907|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.2|-1.3|0.907
91615553|NCT04742907|183124628|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.856|TWO_SIDED|95.0|-1.3|1.6|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.6|-1.3|0.856
91615554|NCT04742907|183124628|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.18|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.5|-2.7|0.180
91615555|NCT04742907|183124628|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.814|TWO_SIDED|95.0|-1.9|2.4|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.4|-1.9|0.814
91615556|NCT04742907|183124628|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.409|TWO_SIDED|95.0|-3.2|1.3|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.3|-3.2|0.409
91615557|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.46|1.4||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.40|0.46|0.430
91615558|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|1.1||||0.739|TWO_SIDED|95.0|0.62|1.96||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.96|0.62|0.739
91615559|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.54||||0.13|TWO_SIDED|95.0|0.25|1.2||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.20|0.25|0.130
91615560|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.52||||0.099|TWO_SIDED|95.0|0.24|1.13||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.13|0.24|0.099
91615561|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.78||||0.686|TWO_SIDED|95.0|0.23|2.63||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.63|0.23|0.686
91615562|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.75||||0.644|TWO_SIDED|95.0|0.22|2.56||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.56|0.22|0.644
91656384|NCT01644500|183206145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
91656385|NCT01644500|183206148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91656386|NCT01644500|183206148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91656387|NCT01644500|183206149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91656388|NCT01644500|183206149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91656389|NCT04084483|183206190|SUPERIORITY|||||||0.2175|||||||ANCOVA|||||||0.2175
91656390|NCT04084483|183206191|SUPERIORITY|||||||0.3852|||||||ANCOVA|||||||0.3852
91656391|NCT04084483|183206192|SUPERIORITY|||||||0.298|||||||ANCOVA|||||||0.2980
91656392|NCT04084483|183206193|SUPERIORITY|||||||0.0634|||||||ANCOVA|||||||0.0634
91656393|NCT04084483|183206194|SUPERIORITY|||||||0.7388|||||||ANCOVA|||Corneal Sum||||0.7388
91656394|NCT04084483|183206194|SUPERIORITY|||||||0.3717|||||||ANCOVA|||Corneal Sum||||0.3717
91656395|NCT04084483|183206194|SUPERIORITY|||||||0.3164|||||||ANCOVA|||Conjunctival Sum||||0.3164
91656396|NCT04084483|183206194|SUPERIORITY|||||||0.1953|||||||ANCOVA|||Conjunctival Sum||||0.1953
91656397|NCT04084483|183206194|SUPERIORITY|||||||0.4645|||||||ANCOVA|||Total Eye Sum||||0.4645
91656398|NCT04084483|183206194|SUPERIORITY|||||||0.2135|||||||ANCOVA|||Total Eye Sum||||0.2135
91615563|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.54||||0.498|TWO_SIDED|95.0|0.09|3.18||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.18|0.09|0.498
91615564|NCT04742907|183124629|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7|TWO_SIDED|95.0|0.12|4.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||4.05|0.12|0.700
91615565|NCT04742907|183124630|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.9|0.8|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-0.9|0.919
91615566|NCT04742907|183124630|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.016|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||-0.2|-1.8|0.016
91615567|NCT04742907|183124630|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.0|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.0|-0.1|0.064
91656399|NCT04084483|183206195|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||0.5990
91656400|NCT04084483|183206195|SUPERIORITY|||||||0.2122|||||||ANCOVA|||||||0.2122
91656401|NCT04084483|183206196|SUPERIORITY|||||||0.9146|||||||ANCOVA|||||||0.9146
91656402|NCT04084483|183206196|SUPERIORITY|||||||0.8494|||||||ANCOVA|||||||0.8494
91656403|NCT04084483|183206197|SUPERIORITY|||||||0.4747|||||||ANCOVA|||||||0.4747
91656404|NCT04084483|183206197|SUPERIORITY|||||||0.5619|||||||ANCOVA|||||||0.5619
91656405|NCT04084483|183206198|SUPERIORITY|||||||0.5985|||||||ANCOVA|||||||0.5985
91656406|NCT04084483|183206198|SUPERIORITY|||||||0.7626|||||||ANCOVA|||||||0.7626
91656407|NCT04084483|183206199|SUPERIORITY|||||||0.833|||||||ANCOVA|||||||0.8330
91656408|NCT04084483|183206199|SUPERIORITY|||||||0.2777|||||||ANCOVA|||||||0.2777
91656409|NCT04084483|183206200|SUPERIORITY|||||||0.9829|||||||ANCOVA|||||||0.9829
91656410|NCT04084483|183206200|SUPERIORITY|||||||0.8675|||||||ANCOVA|||||||0.8675
91656411|NCT04084483|183206201|SUPERIORITY|||||||0.5836|||||||ANCOVA|||||||0.5836
91656412|NCT04084483|183206201|SUPERIORITY|||||||0.2352|||||||ANCOVA|||||||0.2352
91656413|NCT04084483|183206202|SUPERIORITY|||||||0.7367|||||||ANCOVA|||Ocular Discomfort||||0.7367
91656414|NCT04084483|183206202|SUPERIORITY|||||||0.3865|||||||ANCOVA|||Ocular Discomfort||||0.3865
91656415|NCT04084483|183206202|SUPERIORITY|||||||0.8796|||||||ANCOVA|||Burning||||0.8796
91656416|NCT04084483|183206202|SUPERIORITY|||||||0.3515|||||||ANCOVA|||Burning||||0.3515
91656417|NCT04084483|183206202|SUPERIORITY|||||||0.6338|||||||ANCOVA|||Dryness||||0.6338
91656418|NCT04084483|183206202|SUPERIORITY|||||||0.4685|||||||ANCOVA|||Dryness||||0.4685
91656419|NCT04084483|183206202|SUPERIORITY|||||||0.4757|||||||ANCOVA|||Grittiness||||0.4757
91656420|NCT04084483|183206202|SUPERIORITY|||||||0.8803|||||||ANCOVA|||Grittiness||||0.8803
91656421|NCT04084483|183206202|SUPERIORITY|||||||0.8529|||||||ANCOVA|||Stinging||||0.8529
91656422|NCT04084483|183206202|SUPERIORITY|||||||0.7713|||||||ANCOVA|||Stinging||||0.7713
91656423|NCT04084483|183206203|SUPERIORITY|||||||0.138|||||||ANCOVA|||Burning/Stinging||||0.1380
91656424|NCT04084483|183206203|SUPERIORITY|||||||0.3334|||||||ANCOVA|||Burning/Stinging||||0.3334
91656425|NCT04084483|183206203|SUPERIORITY|||||||0.1008|||||||ANCOVA|||Itching||||0.1008
91656426|NCT04084483|183206203|SUPERIORITY|||||||0.4582|||||||ANCOVA|||Itching||||0.4582
91656427|NCT04084483|183206203|SUPERIORITY|||||||0.1511|||||||ANCOVA|||Foreign Body Sensation||||0.1511
91656428|NCT04084483|183206203|SUPERIORITY|||||||0.2555|||||||ANCOVA|||Foreign Body Sensation||||0.2555
91656429|NCT04084483|183206203|SUPERIORITY|||||||0.1546|||||||ANCOVA|||Blurry Vision||||0.1546
91656430|NCT04084483|183206203|SUPERIORITY|||||||0.0495|||||||ANCOVA|||Blurry Vision||||0.0495
91656431|NCT04084483|183206203|SUPERIORITY|||||||0.5791|||||||ANCOVA|||Eye Dryness||||0.5791
91656432|NCT04084483|183206203|SUPERIORITY|||||||0.0736|||||||ANCOVA|||Eye Dryness||||0.0736
91656433|NCT04084483|183206203|SUPERIORITY|||||||0.3666|||||||ANCOVA|||Photophobia||||0.3666
91656434|NCT04084483|183206203|SUPERIORITY|||||||0.039|||||||ANCOVA|||Photophobia||||0.0390
91656435|NCT04084483|183206203|SUPERIORITY|||||||0.0655|||||||ANCOVA|||Pain||||0.0655
91656436|NCT04084483|183206203|SUPERIORITY|||||||0.1947|||||||ANCOVA|||Pain||||0.1947
91656437|NCT04084483|183206204|SUPERIORITY|||||||0.9274|||||||ANCOVA|||||||0.9274
91656438|NCT04084483|183206204|SUPERIORITY|||||||0.0888|||||||ANCOVA|||||||0.0888
91656439|NCT00765648|183206205|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.3||||0.04|TWO_SIDED|95.0|-18.0|-0.6|||Chi-squared|||||-0.6|-18.0|0.04
91656440|NCT00765648|183206206|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
91656441|NCT00765648|183206207|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
91656442|NCT00765648|183206208|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Chi-squared|||||||0.38
91656443|NCT00765648|183206209|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|95.0|||||Chi-squared|||||||0.18
91656444|NCT00765648|183206210|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
91656445|NCT00486837|183206232|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||ANCOVA|||||||0.197
91711940|NCT02754518|183315308|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
91711941|NCT02754518|183315309|OTHER|||||||0.02||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.02
91615568|NCT04742907|183124630|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.683|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-1.3|0.683
91615569|NCT04742907|183124630|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.462|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.1|-1.0|0.462
91615570|NCT04742907|183124630|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.343|TWO_SIDED|95.0|-2.3|0.8|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-2.3|0.343
91615571|NCT00436969|183124651|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.472||||0.696|TWO_SIDED|95.0|-8.888|5.943||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||5.943|-8.888|0.696
91615572|NCT00436969|183124652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-15.6|15.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||15.1|-15.6|
91615573|NCT00436969|183124653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-19.7|9.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||9.1|-19.7|
91615574|NCT00436969|183124654|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.87||||0.827|TWO_SIDED|95.0|-8.698|6.957||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.957|-8.698|0.827
91615575|NCT00436969|183124655|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.875||||0.392|TWO_SIDED|95.0|-9.472|3.723||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.723|-9.472|0.392
91615576|NCT00436969|183124656|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.932||||0.772|TWO_SIDED|95.0|-7.26|5.396||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.396|-7.260|0.772
91615577|NCT00436969|183124657|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.028||||0.707|TWO_SIDED|95.0|-4.338|6.393||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.393|-4.338|0.707
91656446|NCT05630547|183206295|SUPERIORITY||LS Geometric Mean Ratio to Baseline|0.986||||0.8042|TWO_SIDED|95.0|0.881|1.103|||MMRM|||Analysis was performed using mixed-effect model with repeated measures (MMRM) including the fixed categorical effects of the treatment group, multiple sclerosis (MS) clinical subtype (relapsing remitting multiple sclerosis \[RRMS\], secondary progressive multiple sclerosis \[SPMS\], or primary progressive multiple sclerosis \[PPMS\]), visit, treatment-by-visit interaction, log-transformed baseline sNfL levels and log-transformed baseline sNfL levels-by-visit interaction.||1.103|0.881|0.8042
91615578|NCT00436969|183124658|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.82||||0.79|TWO_SIDED|95.0|-6.866|5.227||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.227|-6.866|0.790
91615579|NCT00436969|183124659|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.13||||0.685|TWO_SIDED|95.0|-4.341|6.001||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.001|-4.341|0.685
91615580|NCT00436969|183124660|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.317||||0.018|TWO_SIDED|95.0|1.249|13.386||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||13.386|1.249|0.018
91615581|NCT00436969|183124661|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.361||||0.369|TWO_SIDED|95.0|-2.801|7.522||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||7.522|-2.801|0.369
91615582|NCT00436969|183124662|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79||||0.41|TWO_SIDED|95.0|-9.441|3.861||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||3.861|-9.441|0.410
91615583|NCT00436969|183124663|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.617||||0.379|TWO_SIDED|95.0|-3.226|8.46||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||8.460|-3.226|0.379
91615584|NCT00436969|183124664|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.208||||0.409|TWO_SIDED|95.0|-7.455|3.039||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.039|-7.455|0.409
91615585|NCT00436969|183124665|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.558||||0.232|TWO_SIDED|95.0|-4.119|1.003||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||1.003|-4.119|0.232
91615586|NCT00436969|183124666|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.228||||0.832|TWO_SIDED|95.0|-2.343|1.887||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||1.887|-2.343|0.832
91656447|NCT05065502|183206304|SUPERIORITY||Mean Difference (Net)|-0.261|STANDARD_ERROR_OF_MEAN|0.238||0.273|TWO_SIDED|95.0|-0.728|0.206||Significance level is set at 0.05.|Regression, Linear||Between-arm difference at 13-18 months post-baseline, controlling for rates 1-6 months pre-baseline|Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs of post-intervention period (months 13 to 18), controlling for use in pre-baseline period (months 0 to 6), averaged across three studies.||0.206|-0.728|0.273
91656448|NCT05065502|183206305|SUPERIORITY||Mean Difference (Net)|0.00138|||||TWO_SIDED|95.0|-0.0245|0.0272||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.0272|-0.0245|
91711942|NCT02754518|183315310|OTHER||||||<|0.001||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
91711943|NCT02754518|183315311|OTHER|||||||0.82||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.82
91615587|NCT00436969|183124667|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.068||||0.957|TWO_SIDED|95.0|-2.396|2.532||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.532|-2.396|0.957
91615588|NCT00436969|183124668|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.22||||0.267|TWO_SIDED|95.0|-0.937|3.378||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.378|-0.937|0.267
91711944|NCT02754518|183315312|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
91615589|NCT00436969|183124669|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.19||||0.333|TWO_SIDED|95.0|-1.225|3.604||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||3.604|-1.225|0.333
91615590|NCT00436969|183124670|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.771||||0.473|TWO_SIDED|95.0|-1.339|2.881||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.881|-1.339|0.473
91615591|NCT00436969|183124671|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.018||||0.988|TWO_SIDED|95.0|-2.314|2.278||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.278|-2.314|0.988
91615592|NCT00436969|183124672|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.467||||0.671|TWO_SIDED|95.0|-1.692|2.627||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.627|-1.692|0.671
91615593|NCT02749721|183124735|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91615594|NCT02749721|183124736|OTHER|||||||0.012|||||||Paired t-test|||||||0.012
91615595|NCT02749721|183124737|OTHER||Pearson's R|0.125||||0.61|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (amplitude) baseline scores||||0.610
91711945|NCT02754518|183315313|OTHER|||||||0.01||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.01
91711946|NCT02754518|183315314|OTHER|||||||0.11||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.11
91711947|NCT02754518|183315315|OTHER|||||||0.17||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.17
91711948|NCT02754518|183315316|OTHER|||||||0.035||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.035
91615596|NCT02749721|183124737|OTHER||Pearson's R|-0.294||||0.288|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (amplitude) baseline scores||||0.288
91615597|NCT02749721|183124737|OTHER||Pearson's R|-0.405||||0.134|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (amplitude) baseline scores||||0.134
91615598|NCT02749721|183124737|OTHER||Pearson's R|-0.397||||0.083|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (amplitude) baseline scores||||0.083
91615599|NCT02749721|183124737|OTHER||Pearson's R|-0.476||||0.034|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (amplitude) baseline scores||||0.034
91615600|NCT02749721|183124737|OTHER||Pearson's R|-0.509||||0.031|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 baseline scores||||0.031
91615601|NCT02749721|183124737|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (amplitude) baseline scores||||0.500
91711949|NCT02754518|183315317|OTHER|||||||0.059||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.059
91615602|NCT02749721|183124737|OTHER||Pearson's R|0.376||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b baseline scores||||0.185
91615603|NCT02749721|183124737|OTHER||Pearson's R|-0.108||||0.659|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 baseline scores||||0.659
91615604|NCT02749721|183124737|OTHER||Pearson's R|0.125||||0.611|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a baseline scores||||0.611
91615605|NCT02749721|183124737|OTHER||Pearson's R|-0.111||||0.671|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.671
91615606|NCT02749721|183124737|OTHER||Pearson's R|-0.026||||0.931|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.931
91615607|NCT02749721|183124737|OTHER||Pearson's R|0.516||||0.155|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MADRS (baseline to endpoint percent change)||||0.155
91615608|NCT02749721|183124737|OTHER||Pearson's R|0.268||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.297
91656449|NCT05065502|183206306|SUPERIORITY||Mean Difference (Net)|23.0|||||TWO_SIDED|95.0|-23.3|69.3|||||Statistical Assumptions for Valid Inference of a typical Difference-in-Difference model were not met, Estimate computed from modelling Post-period, and adjusting for Pre-period.|Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in medication costs from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).||69.3|-23.3|
91711950|NCT02754518|183315318|OTHER|||||||0.054||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.054
91615609|NCT02749721|183124737|OTHER||Pearson's R|0.184||||0.494|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.494
91615610|NCT02749721|183124737|OTHER||Pearson's R|-0.065||||0.811|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.811
91615611|NCT02749721|183124737|OTHER||Pearson's R|-0.048||||0.877|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.877
91615612|NCT02749721|183124737|OTHER||Pearson's R|-0.246||||0.557|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and DSST (baseline to endpoint percent change)||||0.557
91615613|NCT02749721|183124737|OTHER||Pearson's R|0.182||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.500
91615614|NCT02749721|183124737|OTHER||Pearson's R|0.288||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.297
91615615|NCT02749721|183124737|OTHER|Differences in BNA scores between MDD and healthy subjects were analyzed for baseline visits using an ANCOVA model with group as a factor, and age as a covariate.|F statistic|0.318||||0.575|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.575
91615616|NCT02749721|183124737|OTHER||F statistic|0.378||||0.541|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.541
91615617|NCT02749721|183124737|OTHER||F|0.012||||0.912|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.912
91615618|NCT02749721|183124737|OTHER||F statistic|1.586||||0.214|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.214
91615619|NCT02749721|183124737|OTHER||F statistic|0.453||||0.504|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.504
91615620|NCT02749721|183124737|OTHER||F statistic|0.37||||0.546|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.546
91615621|NCT02749721|183124737|OTHER||F statistic|0.017||||0.895|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.895
91615622|NCT02749721|183124737|OTHER||F statistic|0.179||||0.673|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.673
91615623|NCT02749721|183124737|OTHER||F statistic|1.241||||0.27|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.27
91615624|NCT02749721|183124737|OTHER||F statistic|0.042||||0.837|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.837
91615625|NCT02749721|183124738|OTHER||Pearson's R|0.359||||0.143|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline scores||||0.143
91615626|NCT02749721|183124738|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.500
91615627|NCT02749721|183124738|OTHER||Pearson's R|0.277||||0.337|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.337
91615628|NCT02749721|183124738|OTHER||Pearson's R|0.052||||0.832|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (latency) baseline scores||||0.832
91615629|NCT02749721|183124738|OTHER||Pearson's R|0.103||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (latency) baseline scores||||0.68
91615630|NCT02749721|183124738|OTHER||Pearson's R|-0.074||||0.777|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline to endpoint percentage change||||0.777
91615631|NCT02749721|183124738|OTHER||Pearson's R|0.061||||0.834|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (Latency) baseline to endpoint percentage change||||0.834
91615632|NCT02749721|183124738|OTHER||Pearson's R|-0.006||||0.988|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (Latency) baseline to endpoint percentage change||||0.988
91615633|NCT02749721|183124738|OTHER||Pearson's R|0.073||||0.788|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (Latency) baseline to endpoint percentage change||||0.788
91615634|NCT02749721|183124738|OTHER||Pearson's R|0.375||||0.168|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (Latency) baseline to endpoint percentage change||||0.168
91615635|NCT02749721|183124738|OTHER||Pearson's R|-0.392||||0.108|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline scores||||0.108
91711951|NCT02754518|183315319|OTHER|||||||0.28||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.28
91615636|NCT02749721|183124738|OTHER||Pearson's R|0.415||||0.124|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline scores||||0.124
91615637|NCT02749721|183124738|OTHER||Pearson's R|0.362||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline scores||||0.185
91615638|NCT02749721|183124738|OTHER||Pearson's R|-0.023||||0.923|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline scores||||0.923
91615639|NCT02749721|183124738|OTHER||Pearson's R|0.071||||0.77|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline scores||||0.77
91615640|NCT02749721|183124738|OTHER||Pearson's R|0.097||||0.712|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline to endpoint percent change||||0.712
91615641|NCT02749721|183124738|OTHER||Pearson's R|-0.058||||0.845|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline to endpoint percent change||||0.845
91615642|NCT02749721|183124738|OTHER||Pearson's R|0.194||||0.616|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline to endpoint percent change||||0.616
91615643|NCT02749721|183124738|OTHER||Pearson's R|0.255||||0.323|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline to endpoint percent change||||0.323
91615644|NCT02749721|183124738|OTHER||Pearson's R|-0.193||||0.473|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline to endpoint percent change||||0.473
91615645|NCT02749721|183124738|OTHER||F statistic|4.909||||0.031|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.031
91615646|NCT02749721|183124738|OTHER||F statistic|1.189||||0.281|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.281
91615647|NCT02749721|183124738|OTHER||F statistic|0.001||||0.966|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.966
91615648|NCT02749721|183124738|OTHER||F statistic|4.121||||0.048|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.048
91615649|NCT02749721|183124738|OTHER||F statistic|8.573||||0.005|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.005
91615650|NCT02749721|183124738|OTHER||F statistic|2.823||||0.101|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.101
91615651|NCT02749721|183124738|OTHER||F statistic|0.806||||0.373|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.373
91615652|NCT02749721|183124738|OTHER||F statistic|1.822||||0.183|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.183
91615653|NCT02749721|183124738|OTHER||F statistic|0.516||||0.475|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.475
91615654|NCT02749721|183124738|OTHER||F statistic|0.214||||0.645|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.645
91615655|NCT02749721|183124739|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91615656|NCT02749721|183124740|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91615657|NCT02749721|183124741|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91615658|NCT02749721|183124742|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91615659|NCT02749721|183124743|OTHER||Pearson's R|-0.044||||0.859|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline scores||||0.859
91615660|NCT02749721|183124743|OTHER||Pearson's R|-0.211||||0.451|TWO_SIDED||||||Pearson's correlation|||AOB P3a (amplitude)||||0.451
91615661|NCT02749721|183124743|OTHER||Pearson's R|0.015||||0.957|TWO_SIDED||||||Pearson's correlation|||AOB P3b (amplitude)||||0.957
91527421|NCT01003184|182930058|SUPERIORITY_OR_OTHER||Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.322||0.3247|TWO_SIDED|95.0|0.19|1.72|||Poisson regression|||The number of episodes by patient were compared between treatment groups using a poisson model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||1.72|0.19|0.3247
91615662|NCT02749721|183124743|OTHER||Pearson's R|-0.322||||0.166|TWO_SIDED||||||Pearson's correlation|||VGNG P200 (amplitude)||||0.166
91615663|NCT02749721|183124743|OTHER||Pearson's R|-0.374||||0.105|TWO_SIDED||||||Pearson's correlation|||VGNG P3a (amplitude)||||0.105
91615664|NCT02749721|183124743|OTHER||Pearson's R|-0.137||||0.601|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline to endpoint percent change||||0.601
91615665|NCT02749721|183124743|OTHER||Pearson's R|-0.234||||0.421|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.421
91615666|NCT02749721|183124743|OTHER||Pearson's R|0.378||||0.316|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-28 baseline to endpoint percent change||||0.316
91615667|NCT02749721|183124743|OTHER||Pearson's R|0.185||||0.478|TWO_SIDED||||||Pearson's correlation|||||||0.478
91615668|NCT02749721|183124743|OTHER||Pearson's R|0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.969
91615669|NCT02749721|183124743|OTHER||Pearson's R|-0.018||||0.943|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline scores||||0.943
91615670|NCT02749721|183124743|OTHER||Pearson's R|-0.074||||0.795|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline scores||||0.795
91615671|NCT02749721|183124743|OTHER||Pearson's R|-0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline scores||||0.969
91615672|NCT02749721|183124743|OTHER||Pearson's R|-0.197||||0.406|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline scores||||0.406
91615673|NCT02749721|183124743|OTHER||Pearson's R|-0.309||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline scores||||0.185
91615674|NCT02749721|183124743|OTHER||Pearson's R|-0.195||||0.454|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.454
91615675|NCT02749721|183124743|OTHER||Pearson's R|-0.162||||0.579|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.579
91656450|NCT05065502|183206307|SUPERIORITY||Median Difference (Net)|-0.599|||||TWO_SIDED|95.0|-1.08|-0.122||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of medication note reviews from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).|"Medication reviews per 1,000 patients (outcome multiplied by 1,000).~Statistical Assumptions for Valid Inference of a typical Difference-in-Difference model were not met, Estimate computed from modelling Post-period, and adjusting for Pre-period."|-0.122|-1.080|
91656451|NCT05065502|183206308|SUPERIORITY||Mean Difference (Net)|-0.05317|||||TWO_SIDED|95.0|-0.09073|0.01561||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of inappropriate use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18)||0.01561|-0.09073|
91656452|NCT05065502|183206309|SUPERIORITY||Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-1.44|1.2||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).||1.20|-1.44|
91656453|NCT05065502|183206310|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.83|0.42||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of of high-risk DOAC use attributable to chronic kidney disease for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6), ), controlling for the pre-baseline period (months 0 to 6).||0.42|-0.83|
91711952|NCT02754518|183315320|OTHER|||||||0.002||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.002
91615676|NCT02749721|183124743|OTHER||Pearson's R|0.232||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline to endpoint percent change||||0.549
91615677|NCT02749721|183124743|OTHER||Pearson's R|0.169||||0.518|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.518
91615678|NCT02749721|183124743|OTHER||Pearson's R|0.027||||0.922|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.922
91615679|NCT02749721|183124743|OTHER||Pearson's R|-0.064||||0.796|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline scores||||0.796
91615680|NCT02749721|183124743|OTHER||Pearson's R|-0.506||||0.054|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline scores||||0.054
91615681|NCT02749721|183124743|OTHER||Pearson's R|0.002||||0.995|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and QIDS-SR baseline scores||||0.995
91615682|NCT02749721|183124743|OTHER||Pearson's R|0.102||||0.668|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline scores||||0.668
91615683|NCT02749721|183124743|OTHER||Pearson's R|0.037||||0.875|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline scores||||0.875
91615684|NCT02749721|183124743|OTHER||Pearson's R|-0.049||||0.852|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.852
91615685|NCT02749721|183124743|OTHER||Pearson's R|-0.34||||0.234|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.234
91615686|NCT02749721|183124743|OTHER||Pearson's R|0.655||||0.056|TWO_SIDED||||||Pearson's correlation|||||||0.056
91615687|NCT02749721|183124743|OTHER||Pearson's R|0.297||||0.248|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.248
91615688|NCT02749721|183124743|OTHER||Pearson's R|0.179||||0.507|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.507
91615689|NCT02749721|183124743|OTHER||Pearson's R|0.049||||0.841|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline scores||||0.841
91615690|NCT02749721|183124743|OTHER||Pearson's R|-0.185||||0.508|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline scores||||0.508
91615691|NCT02749721|183124743|OTHER||Pearson's R|-0.03||||0.916|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline scores||||0.916
91615692|NCT02749721|183124743|OTHER||Pearson's R|-0.345||||0.147|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline scores||||0.147
91615693|NCT02749721|183124743|OTHER||Pearson's R|-0.284||||0.225|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline scores||||0.225
91615694|NCT02749721|183124743|OTHER||Pearson's R|-0.044||||0.868|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline to endpoint percent change||||0.868
91615695|NCT02749721|183124743|OTHER||Pearson's R|-0.18||||0.537|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline to endpoint percent change||||0.537
91615696|NCT02749721|183124743|OTHER||Pearson's R|0.476||||0.195|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline to endpoint percent change||||0.195
91615697|NCT02749721|183124743|OTHER||Pearson's R|0.594||||0.015|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline to endpoint percent change||||0.015
91615698|NCT02749721|183124743|OTHER||Pearson's R|-0.009||||0.972|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline to endpoint percent change||||0.972
91615699|NCT02749721|183124743|OTHER||Pearson's R|0.067||||0.785|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline scores||||0.785
91615700|NCT02749721|183124743|OTHER||Pearson's R|-0.129||||0.646|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline scores||||0.646
91615701|NCT02749721|183124743|OTHER||Pearson's R|0.364||||0.182|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline scores||||0.182
91615702|NCT02749721|183124743|OTHER||Pearson's R|-0.414||||0.069|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline scores||||0.069
91615703|NCT02749721|183124743|OTHER||Pearson's R|-0.416||||0.068|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline scores||||0.068
91615704|NCT02749721|183124743|OTHER||Pearson's R|-0.023||||0.929|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.929
91615705|NCT02749721|183124743|OTHER||Pearson's R|-0.074||||0.802|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.802
91615706|NCT02749721|183124743|OTHER||Pearson's R|0.518||||0.153|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.153
91656454|NCT05065502|183206311|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.08|0.72||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to weight for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.72|-0.08|
91656455|NCT05065502|183206312|SUPERIORITY||Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.7|0.33||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to mis-dosing for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.33|-0.70|
91656456|NCT05065502|183206313|SUPERIORITY||Mean Difference (Net)|0.01007|||||TWO_SIDED|95.0|-0.02415|0.04429||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of CBTI receipt for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6)||0.04429|-0.02415|
91656457|NCT05065502|183206316|SUPERIORITY||Mean Difference (Net)|-0.0837|||||TWO_SIDED|95.0|-0.21014|0.04275||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.04275|-0.21014|
91656458|NCT05065502|183206317|SUPERIORITY||Mean Difference (Net)|0.102|||||TWO_SIDED|95.0|-0.216|0.42||||||||0.420|-0.216|
91656459|NCT05065502|183206318|SUPERIORITY||Mean Difference (Net)|-0.0389|||||TWO_SIDED|95.0|-0.555|0.477||||||||0.477|-0.555|
91656460|NCT05065502|183206319|SUPERIORITY||Mean Difference (Net)|0.101|||||TWO_SIDED|95.0|-0.25|0.452||||||||0.452|-0.250|
91656461|NCT05065502|183206320|SUPERIORITY||Mean Difference (Net)|-0.0428|||||TWO_SIDED|95.0|-0.339|0.254||||||||0.254|-0.339|
91656462|NCT00117949|183206344|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
91656463|NCT00117949|183206344|SUPERIORITY_OR_OTHER||Median days to insufficient T response|84.0||||||95.0|35.0|112.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.||112|35|
91656464|NCT00117949|183206344|SUPERIORITY_OR_OTHER||Median days to insufficient T response|98.0||||||95.0|70.0|126.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||126|70|
91656465|NCT00117949|183206344|SUPERIORITY_OR_OTHER||Median days to insufficient T response|35.0||||||95.0|14.0|98.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||98|14|
91656466|NCT00117949|183206345|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|Participants not castrated were censored as of the days from dosing for the last available observation.||||||0.003
91656467|NCT00117949|183206345|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|3.0|7.0||||||Kaplan-Meier estimates of the median time to testosterone castration.||7|3|
91656468|NCT00117949|183206345|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|1.0|3.0||||||Kaplan-Meier estimates of the time to testosterone castration.||3|1|
91656469|NCT00117949|183206346|SUPERIORITY_OR_OTHER||Percentage of participants|0.0||||||95.0|0.0|0.0||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||0|0|
91656470|NCT00117949|183206346|SUPERIORITY_OR_OTHER||Percentage of participants|42.7||||||95.0|22.0|63.4||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||63.4|22|
91656471|NCT00117949|183206346|SUPERIORITY_OR_OTHER||Percentage of participants|61.6||||||95.0|41.8|81.3||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||81.3|41.8|
91656472|NCT00117949|183206346|SUPERIORITY_OR_OTHER||Percentage of participants|35.6||||||95.0|15.8|55.5||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||55.5|15.8|
91656473|NCT00117949|183206347|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||Cochran-Armitage Trend Test.|||||||0.181
91656474|NCT00117949|183206347|SUPERIORITY_OR_OTHER||Percentage of participants|10.0||||||95.0|0.3|44.5||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||44.5|0.3|
91656475|NCT00117949|183206347|SUPERIORITY_OR_OTHER||Percentage of participants|70.8||||||95.0|48.9|87.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||87.4|48.9|
91656476|NCT00117949|183206347|SUPERIORITY_OR_OTHER||Percentage of participants|79.2||||||95.0|57.8|92.9||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||92.9|57.8|
91527422|NCT05266963|182930100|SUPERIORITY|Statistical analysis will be performed using a paired samples Wilcoxon test to compare differences between the two groups.||||||0.43|||||||Wilcoxon (Mann-Whitney)|Wilcoxon matched-pairs||||||0.43
91527423|NCT05266963|182930101|SUPERIORITY|Statistical analysis will be performed using a standard two-tailed t test to compare differences between the two groups.||||||0.52|||||||t-test, 2 sided|||||||0.52
91656477|NCT00117949|183206347|SUPERIORITY_OR_OTHER||Percentage of participants|54.2||||||95.0|32.8|74.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||74.4|32.8|
91656478|NCT00117949|183206348|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Log Rank|||||||0.046
91656479|NCT00117949|183206348|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
91656480|NCT00117949|183206348|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
91656481|NCT00117949|183206348|SUPERIORITY_OR_OTHER||days|28.0||||||95.0|14.0|41.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||41|14|
91656482|NCT00117949|183206349|SUPERIORITY_OR_OTHER|||||||0.926||95.0|||||Log Rank|||||||0.926
91656483|NCT00117949|183206349|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|56.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||56|35|
91656484|NCT00117949|183206349|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|84.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||84|35|
91656485|NCT00117949|183206349|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|100.0|||||The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.|Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||100|35|
91656486|NCT02099461|183206364|SUPERIORITY_OR_OTHER||LS Mean|0.15||||0.2966|TWO_SIDED|95.0|-0.136|0.441|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.441|-0.136|0.2966
91615707|NCT02749721|183124743|OTHER||Pearson's R|0.268||||0.298|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.298
91615708|NCT02749721|183124743|OTHER||Pearson's R|-0.001||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.996
91615709|NCT02749721|183124743|OTHER||Pearson's R|0.242||||0.531|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline scores||||0.531
91615710|NCT02749721|183124743|OTHER||Pearson's R|-0.598||||0.21|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline scores||||0.210
91615711|NCT02749721|183124743|OTHER||Pearson's R|0.054||||0.899|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline scores||||0.899
91615712|NCT02749721|183124743|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||||||0.087
91615713|NCT02749721|183124743|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline scores||||0.087
91615714|NCT02749721|183124743|OTHER||Pearson's R|0.231||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline to endpoint percent change||||0.550
91615715|NCT02749721|183124743|OTHER||Pearson's R|0.158||||0.766|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline to endpoint percent change||||0.766
91615716|NCT02749721|183124743|OTHER||Pearson's R|-0.406||||0.498|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline to endpoint percent change||||0.498
91615717|NCT02749721|183124743|OTHER||Pearson's R|0.221||||0.599|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and WLQ baseline to endpoint percent change||||0.599
91615718|NCT02749721|183124743|OTHER||Pearson's R|0.679||||0.064|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline to endpoint percent change||||0.064
91615719|NCT02749721|183124744|OTHER||Pearson's R|-0.038||||0.881|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline scores||||0.881
91615720|NCT02749721|183124744|OTHER||Pearson's R|0.299||||0.279|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline scores||||0.279
91615721|NCT02749721|183124744|OTHER||Pearson's R|0.538||||0.039|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline scores||||0.039
91615722|NCT02749721|183124744|OTHER||Pearson's R|-0.018||||0.94|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline scores||||0.940
91615723|NCT02749721|183124744|OTHER||Pearson's R|0.107||||0.65|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline scores||||0.65
91615724|NCT02749721|183124744|OTHER||Pearson's R|0.247||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.340
91615725|NCT02749721|183124744|OTHER||Pearson's R|0.067||||0.819|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.819
91615726|NCT02749721|183124744|OTHER||Pearson's R|0.321||||0.4|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline to endpoint percentage change||||0.400
91615727|NCT02749721|183124744|OTHER||Pearson's R|0.279||||0.278|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.278
91615728|NCT02749721|183124744|OTHER||Pearson's R|-0.136||||0.614|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.614
91615729|NCT02749721|183124744|OTHER||Pearson's R|0.0||||0.999|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline scores||||0.999
91615730|NCT02749721|183124744|OTHER||Pearson's R|0.193||||0.491|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline scores||||0.491
91615731|NCT02749721|183124744|OTHER||Pearson's R|0.567||||0.028|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline scores||||0.028
91615732|NCT02749721|183124744|OTHER||Pearson's R|-0.03||||0.9|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-17 baseline scores||||0.900
91615733|NCT02749721|183124744|OTHER||Pearson's R|0.141||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline scores||||0.55
91615734|NCT02749721|183124744|OTHER||Pearson's R|0.231||||0.373|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.373
91615735|NCT02749721|183124744|OTHER||Pearson's R|0.019||||0.949|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.949
91615736|NCT02749721|183124744|OTHER||Pearson's R|0.122||||0.754|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline to endpoint percent change||||0.754
91615737|NCT02749721|183124744|OTHER||Pearson's R|0.176||||0.499|TWO_SIDED||||||0.176|||Correlation between VGNG P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.499
91615738|NCT02749721|183124744|OTHER||Pearson's R|-0.162||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.549
91615739|NCT02749721|183124744|OTHER||Pearson's R|-0.126||||0.617|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline scores||||0.617
91615740|NCT02749721|183124744|OTHER||Pearson's R|0.1||||0.722|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline scores||||0.722
91615741|NCT02749721|183124744|OTHER||Pearson's R|0.249||||0.371|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline scores||||0.371
91615742|NCT02749721|183124744|OTHER||Pearson's R|-0.072||||0.764|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline scores||||0.764
91615743|NCT02749721|183124744|OTHER||Pearson's R|-0.225||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline scores||||0.34
91615744|NCT02749721|183124744|OTHER||Pearson's R|0.148||||0.57|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.570
91615745|NCT02749721|183124744|OTHER||Pearson's R|0.228||||0.434|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.434
91656487|NCT02099461|183206364|SUPERIORITY_OR_OTHER||LS Mean|-0.16||||0.2769|TWO_SIDED|95.0|-0.447|0.13|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.130|-0.447|0.2769
91656488|NCT02099461|183206364|SUPERIORITY_OR_OTHER||LS Mean|-0.09||||0.5238|TWO_SIDED|95.0|-0.373|0.191|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.191|-0.373|0.5238
91656489|NCT02099461|183206364|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1343|TWO_SIDED|95.0|-0.72|0.098|||ANCOVA||Denosumab 60 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.098|-0.720|0.1343
91656490|NCT02099461|183206364|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.2345|TWO_SIDED|95.0|-0.646|0.161|||ANCOVA||Denosumab 120 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.161|-0.646|0.2345
91656491|NCT00406848|183206369|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.||||0.397
91656492|NCT00406848|183206370|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.115
91656493|NCT00406848|183206370|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.004
91656494|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.773
91615746|NCT02749721|183124744|OTHER||Pearson's R|0.22||||0.569|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline to endpoint percent change||||0.569
91615747|NCT02749721|183124744|OTHER||Pearson's R|0.645||||0.005|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.005
91615748|NCT02749721|183124744|OTHER||Pearson's R|0.105||||0.698|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.698
91615749|NCT02749721|183124744|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline scores||||0.774
91615750|NCT02749721|183124744|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline score||||0.024
91615751|NCT02749721|183124744|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline scores||||0.603
91615752|NCT02749721|183124744|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline scores||||0.326
91615753|NCT02749721|183124744|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline scores||||0.68
91615754|NCT02749721|183124744|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline to endpoint percent change||||0.774
91615755|NCT02749721|183124744|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline to endpoint percent change||||0.024
91615756|NCT02749721|183124744|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline to endpoint percent change||||0.603
91615757|NCT02749721|183124744|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline to endpoint percent change||||0.326
91615758|NCT02749721|183124744|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline to endpoint percent change||||0.68
91615759|NCT02749721|183124744|OTHER||Pearson's R|-0.1||||0.692|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline scores||||0.692
91615760|NCT02749721|183124744|OTHER||Pearson's R|0.498||||0.059|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline scores||||0.059
91615761|NCT02749721|183124744|OTHER||Pearson's R|-0.332||||0.227|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline scores||||0.227
91615762|NCT02749721|183124744|OTHER||Pearson's R|-0.125||||0.6|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline scores||||0.600
91615763|NCT02749721|183124744|OTHER||Pearson's R|-0.096||||0.69|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline scores||||0.69
91615764|NCT02749721|183124744|OTHER||Pearson's R|0.259||||0.315|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.315
91615765|NCT02749721|183124744|OTHER||Pearson's R|0.002||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.996
91615766|NCT02749721|183124744|OTHER||Pearson's R|0.234||||0.544|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline to endpoint percent change||||0.544
91615767|NCT02749721|183124744|OTHER||Pearson's R|0.455||||0.066|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.066
91711953|NCT02754518|183315321|OTHER|||||||0.008||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.008
91711954|NCT02754518|183315322|OTHER|||||||0.005||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.005
91711955|NCT02754518|183315323|OTHER|||||||0.056||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.056
91711956|NCT00872521|183315327|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.09
91711957|NCT00872521|183315328|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
91615768|NCT02749721|183124744|OTHER||Pearson's R|-0.28||||0.293|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.293
91615769|NCT02749721|183124744|OTHER||Pearson's R|0.783||||0.013|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline scores||||0.013
91615770|NCT02749721|183124744|OTHER||Pearson's R|0.135||||0.799|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline scores||||0.799
91615771|NCT02749721|183124744|OTHER||Pearson's R|0.506||||0.201|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline scores||||0.201
91615772|NCT02749721|183124744|OTHER||Pearson's R|-0.197||||0.586|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline scores||||0.586
91615773|NCT02749721|183124744|OTHER||Pearson's R|-0.024||||0.95|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline scores||||0.95
91615774|NCT02749721|183124744|OTHER||Pearson's R|0.039||||0.92|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline to endpoint percent change||||0.920
91615775|NCT02749721|183124744|OTHER||Pearson's R|0.113||||0.831|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline to endpoint percent change||||0.831
91615776|NCT02749721|183124744|OTHER||Pearson's R|0.655||||0.23|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline to endpoint percent change||||0.230
91615777|NCT02749721|183124744|OTHER||Pearson's R|-0.602||||0.115|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline to endpoint percent change||||0.115
91615778|NCT02749721|183124744|OTHER||Pearson's R|-0.313||||0.45|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline to endpoint percent change||||0.450
91615779|NCT00772967|183124745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.611||||0.089||90.0|-1.36|0.14||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.14|-1.36|0.089
91615780|NCT00772967|183124745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.804||||0.043||90.0|-1.57|-0.04||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.04|-1.57|0.043
91615781|NCT00772967|183124746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.518||||0.048||90.0|-1.03|-0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.01|-1.03|0.048
91615782|NCT00772967|183124746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.001||90.0|-1.54|-0.53||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.53|-1.54|0.001
91615783|NCT00772967|183124747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.658||||0.052||90.0|-1.32|0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.01|-1.32|0.052
91615784|NCT00772967|183124747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003||90.0|-1.81|-0.49||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.49|-1.81|0.003
91615785|NCT00772967|183124748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.875||||0.019||90.0|-1.56|-0.19||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.19|-1.56|0.019
91615786|NCT00772967|183124748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.007||90.0|-1.77|-0.37||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.37|-1.77|0.007
91615787|NCT00803244|183124758|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49||||0.2344||95.0|-1.3|0.32|||ANCOVA|||||0.32|-1.30|0.2344
91615788|NCT00803244|183124759|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.09||||0.0401|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA||Relative LS Means difference (%) = -19.7|||0.00|-0.18|0.0401
91615789|NCT00053846|183124775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.483|STANDARD_ERROR_OF_MEAN|0.275||0.08|TWO_SIDED|95.0|-1.02|0.0576|||ANCOVA||Multiple Imputation (MI) used for estimates. MICE software in R was used to generate 100 imputed datasets. ANCOVA was run on each, and results were pooled.|H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.||0.0576|-1.020|0.080
91711958|NCT00872521|183315329|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
91711959|NCT00872521|183315330|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.56
91711960|NCT00872521|183315331|SUPERIORITY_OR_OTHER|||||||0.01|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.01
91656495|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.084
91656496|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||p-value is for Maier subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.059
91656497|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for Bech subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.488
91656498|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.048
91656499|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.529||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.529
91656500|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.027
91656501|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.749
91656502|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.296
91711961|NCT00872521|183315332|SUPERIORITY_OR_OTHER|||||||0.28|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.28
91711962|NCT01411852|183315376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||||TWO_SIDED|95.0|0.12|1.25|||||Adjusted for age (linear spline with knot at 45 years), penetrating vs. blunt or no trauma (1 patient had neither blunt nor penetrating trauma), and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||1.25|0.12|
91711963|NCT01411852|183315377|SUPERIORITY_OR_OTHER||percent difference|-16.0|||||TWO_SIDED|95.0|-26.5|-5.5||||||||-5.5|-26.5|
91711964|NCT01411852|183315378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.76|0.4||||||||0.40|-2.76|
91711965|NCT01411852|183315379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.61|0.08||||||||0.08|-1.61|
91711966|NCT01411852|183315380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-1.8|2.2||||||||2.2|-1.8|
91711967|NCT01411852|183315381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0||||||||1.0|-0.3|
91656503|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.984||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.984
91656504|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.930
91656505|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.934
91656506|NCT00406848|183206371|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.123
91656507|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||p-value is for Severity of Worst Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.034
91656508|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||p-value is for Severity of Worst Pain - Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.100
91656509|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for Severity of Least Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.009
91656510|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||p-value is for Severity of Least Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.126
91656511|NCT00406848|183206372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Severity of Average Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
91656512|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Severity of Average Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
91656513|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Severity of Pain Right Now Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.016
91615790|NCT03382899|183124804|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7626|TWO_SIDED|95.0|0.5|2.5|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on interactive web response system (IWRS). 95% Confidence intervals (CIs) were estimated using the Clopper-Pearson method.|||2.5|0.5|0.7626
91656514|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||p-value is for Severity of Pain Right Now Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.058
91711968|NCT01411852|183315382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|||||TWO_SIDED|95.0|-42.5|1.6||||||||1.6|-42.5|
91615791|NCT03382899|183124805|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.263|TWO_SIDED|95.0|0.722|3.243|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.243|0.722|0.263
91615792|NCT03382899|183124806|SUPERIORITY||Hazard Ratio (HR)|0.975||||0.2|TWO_SIDED|95.0|0.571|1.663|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Kaplan-Meier method.|||1.663|0.571|0.20
91615793|NCT03382899|183124807|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9418|TWO_SIDED|95.0|0.5|2.3|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Clopper-Pearson method.|||2.3|0.5|0.9418
91615794|NCT03382899|183124808|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.8312|TWO_SIDED|95.0|0.384|3.289|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.289|0.384|0.8312
91615795|NCT00576693|183124829|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Log Rank|||The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.||||0.0252
91615796|NCT00540449|183124830|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-0.4|||<|0.0001||95.0|-5.9|5.2||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||5.2|-5.9|<0.0001
91615797|NCT00540449|183124831|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.3|||<|0.0001||95.0|-5.4|5.9|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||5.9|-5.4|<0.0001
91615798|NCT00540449|183124832|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-3.2||||0.0055||95.0|-9.4|3.1|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||3.1|-9.4|0.0055
91615799|NCT00540449|183124833|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-1.7||||0.0013||95.0|-8.0|4.5|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.||||4.5|-8.0|0.0013
91615800|NCT03283163|183124844|OTHER|||||||0.04|||||||t-test, 2 sided|||paired samples t-test to compare PTSD severity from baseline to endpoint (week 13).||||.040
91615801|NCT03283163|183124845|OTHER|||||||0.69|||||||t-test, 2 sided|||paired samples t-test to compare degree of pain-related interference from baseline to endpoint (week 13).||||.69
91615802|NCT03283163|183124846|OTHER|||||||0.098|||||||t-test, 2 sided|||paired samples t-test to compare severity of pain catastrophizing from baseline to endpoint (week 13).||||.098
91615803|NCT03283163|183124847|OTHER|||||||0.194|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of resting ALLO+PA levels from baseline to endpoint (week 13).||||.194
91615804|NCT03283163|183124848|OTHER|paired samples t-test||||||0.343|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of peak ALLO+PA levels (30 minutes post MAXEX) from baseline to endpoint (week 13).||||.343
91615805|NCT04238663|183124856|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|1.06|||||TWO_SIDED|90.0|0.976|1.16|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.16|0.976|
91656515|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for Interference with General Activity Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.011
91711969|NCT01411852|183315383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.06|0.1||||||||0.10|-0.06|
91711970|NCT01411852|183315384|SUPERIORITY_OR_OTHER||percent difference|-10.2|||||TWO_SIDED|95.0|-22.4|2.0||||||||2.0|-22.4|
91711971|NCT01411852|183315385|SUPERIORITY_OR_OTHER||percent difference|-18.9|||||TWO_SIDED|95.0|-39.2|1.4||||||||1.4|-39.2|
91711972|NCT01411852|183315386|SUPERIORITY_OR_OTHER||percent difference|-10.4|||||TWO_SIDED|95.0|-29.6|8.8||||||||8.8|-29.6|
91711973|NCT01411852|183315387|SUPERIORITY_OR_OTHER||percent difference|-4.4|||||TWO_SIDED|95.0|-16.6|7.8||||||||7.8|-16.6|
91711974|NCT01411852|183315388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.8|2.1||||||||2.1|-3.8|
91711975|NCT01411852|183315389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.6|2.4||||||||2.4|-3.6|
91615806|NCT04238663|183124856|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.983|||||TWO_SIDED|90.0|0.897|1.08||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.||1.08|0.897|
91615807|NCT04238663|183124856|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.926|||||TWO_SIDED|90.0|0.851|1.01|||||For Ratio of geometric least square mean (GLSM): EU is the numerator and US Avastin acts as the denominator|||1.01|0.851|
91615808|NCT04238663|183124857|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.0|1.14|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator|||1.14|1.00|
91615809|NCT04238663|183124857|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.998|||||TWO_SIDED|90.0|0.944|1.05|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.05|0.944|
91615810|NCT04238663|183124857|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.934|||||TWO_SIDED|90.0|0.884|0.988|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||0.988|0.884|
91615811|NCT00337467|183124871|SUPERIORITY_OR_OTHER||Percentage of Participants|21.3|||||TWO_SIDED|95.0|11.9|33.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||33.7|11.9|
91615812|NCT00337467|183124872|SUPERIORITY_OR_OTHER||Percentage of Participants|34.4|||||TWO_SIDED|95.0|22.7|47.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||47.7|22.7|
91656516|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Interference with General Activity Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.060
91615813|NCT00337467|183124877|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|61.0|STANDARD_ERROR_OF_MEAN|24.3|||TWO_SIDED|95.0|12.3|109.8|||normal approximation for 95% CI|||||109.8|12.3|
91615814|NCT00337467|183124878|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|30.0|||TWO_SIDED|95.0|-7.1|113.7|||normal approximation for 95% CI|||||113.7|-7.1|
91615815|NCT00337467|183124879|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|63.0|STANDARD_ERROR_OF_MEAN|32.9|||TWO_SIDED|95.0|-4.0|129.1|||normal approximation for 95% CI|||||129.1|-4.0|
91615816|NCT00337467|183124881|SUPERIORITY_OR_OTHER||Mean Change|9.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|2.5|14.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 48||14.6|2.5|
91615817|NCT00337467|183124881|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-3.9|8.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 48||8.8|-3.9|
91615818|NCT00337467|183124881|SUPERIORITY_OR_OTHER||Mean Change|12.0|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|4.0|20.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48||20.8|4.0|
91656517|NCT00406848|183206372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Mood Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
91656518|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Interference with Mood Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
91656519|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Walking Ability Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.019
91656520|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Interference with Walking Ability Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.040
91656521|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Interference with Normal Work Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
91656522|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Interference with Normal Work Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.014
91656523|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
91656524|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
91615819|NCT00337467|183124881|SUPERIORITY_OR_OTHER||Mean Change|20.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|8.0|31.7|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 48||31.7|8.0|
91615820|NCT00337467|183124881|SUPERIORITY_OR_OTHER||Mean Change|17.0|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-0.4|34.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 48||34.4|-0.4|
91615821|NCT00337467|183124882|SUPERIORITY_OR_OTHER||Mean Change|14.0|STANDARD_ERROR_OF_MEAN|3.2||||95.0|6.9|20.1|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 96||20.1|6.9|
91615822|NCT00337467|183124882|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-6.0|10.2|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 96||10.2|-6.0|
91615823|NCT00337467|183124882|SUPERIORITY_OR_OTHER||Mean Change|19.0|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|10.3|28.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96||28.4|10.3|
91615824|NCT00337467|183124882|SUPERIORITY_OR_OTHER||Mean Change|29.0|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|15.3|42.0|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 96||42.0|15.3|
91615825|NCT00337467|183124882|SUPERIORITY_OR_OTHER||Mean Change|16.0|STANDARD_ERROR_OF_MEAN|12.5|||TWO_SIDED|95.0|-9.5|41.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 96||41.6|-9.5|
91615826|NCT01187901|183124887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615827|NCT01187901|183124888|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615828|NCT01187901|183124889|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615829|NCT01187901|183124890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615830|NCT01187901|183124891|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615831|NCT01187901|183124892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91615832|NCT03141086|183124893|SUPERIORITY||Mean Difference (Final Values)|1.711||||0.1272|TWO_SIDED|95.0|-1.34|4.762|||ANOVA|||||4.762|-1.340|0.1272
91615833|NCT03141086|183124894|SUPERIORITY||Mean Difference (Final Values)|2.866||||0.0607|TWO_SIDED|95.0|-0.821|6.553|||Mixed Models Analysis|||3.5 hours post dose||6.553|-0.821|0.0607
91615834|NCT03141086|183124894|SUPERIORITY||Mean Difference (Net)|1.975||||0.0919|TWO_SIDED|95.0|-1.024|4.973|||Mixed Models Analysis|||5.5 hours post dose||4.973|-1.024|0.0919
91615835|NCT03141086|183124894|SUPERIORITY||Mean Difference (Net)|1.576||||0.0811|TWO_SIDED|95.0|-0.697|3.848|||Mixed Models Analysis|||7.5 hours post dose||3.848|-0.697|0.0811
91615836|NCT03141086|183124894|SUPERIORITY||Mean Difference (Net)|0.879||||0.2026|TWO_SIDED|95.0|-1.268|3.026|||Mixed Models Analysis|||9.5 hours post dose||3.026|-1.268|0.2026
91615837|NCT04430582|183124915|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
91615838|NCT04430582|183124916|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91615839|NCT04430582|183124917|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91615840|NCT04430582|183124918|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
91615841|NCT04430582|183124919|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
91615842|NCT04430582|183124920|OTHER|||||||0.95|||||||Kruskal-Wallis|||||||0.95
91615843|NCT04430582|183124921|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91615844|NCT04430582|183124922|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
91615845|NCT04430582|183124923|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91615846|NCT04430582|183124924|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91615847|NCT04430582|183124925|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91615848|NCT04430582|183124926|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91615849|NCT04430582|183124927|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
91615850|NCT04430582|183124928|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
91615851|NCT04430582|183124929|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91615852|NCT02410902|183124940|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-2.56||||0.038|TWO_SIDED|95.0|-4.98|-0.14|||ANCOVA|||||-0.14|-4.98|0.038
91615853|NCT02410902|183124941|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-1.07||||0.325|TWO_SIDED|95.0|-3.21|1.07|||ANCOVA|||||1.07|-3.21|0.325
91615854|NCT00074412|183124942|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
91615855|NCT00074412|183124942|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|2.4|||||TWO_SIDED|95.0|1.3|3.6|||Kaplan-Meier Method|||||3.6|1.3|
91615856|NCT00074412|183124942|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.973||||0.049||95.0||||P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.|Z-test|||Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. \& 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.||||0.049
91615857|NCT00074412|183124944|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|97.7|||||TWO_SIDED|95.0|96.6|98.8|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.8|96.6|
91656525|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||p-value is for Interference with Sleep Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.015
91656526|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Interference with Sleep Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.005
91656527|NCT00406848|183206372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
91656528|NCT00406848|183206372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
91656529|NCT00406848|183206372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Average Interference Score Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
91656530|NCT00406848|183206372|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Average Interference Score Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
91656531|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Overall Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.005
91656532|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||p-value is for Overall Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.204
91711976|NCT01411852|183315390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-2.9|3.1||||||||3.1|-2.9|
91656533|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||p-value is for Headaches Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.078
91656534|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||p-value is for Headaches Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.147
91656535|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value is for Back Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.007
91656536|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Back Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
91656537|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||p-value is for Shoulder Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.124
91656538|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||p-value is for Shoulder Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.231
91656539|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Interference with Daily Activities Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.006
91656540|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Daily Activities Week 25 main effect of treatment.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit||||||0.019
91656541|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Time in Pain While Awake Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
91527424|NCT00152971|182930102|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|5.8||||0.0234||95.0|0.8|10.8||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.8|0.8|0.0234
91656542|NCT00406848|183206373|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Time in Pain While Awake Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.036
91656543|NCT00406848|183206374|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||p-value is for PGI-I at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||0.214
91656544|NCT00406848|183206374|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for PGI-I at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||.063
91656545|NCT00406848|183206375|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.162
91656546|NCT00406848|183206375|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.009
91656547|NCT00406848|183206376|SUPERIORITY_OR_OTHER|||||||0.555||95.0||||p-value is for change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.555
91711977|NCT01411852|183315391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.03|0.92|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||0.92|0.03|
91615858|NCT00074412|183124944|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|96.8|||||TWO_SIDED|95.0|95.5|98.0|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.0|95.5|
91615859|NCT00074412|183124944|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.095||||0.274||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.||||0.274
91615860|NCT00074412|183124944|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|94.5|||||TWO_SIDED|95.0|92.9|96.2|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.||96.2|92.9|
91615861|NCT00074412|183124944|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|93.3|||||TWO_SIDED|95.0|91.5|95.1|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||95.1|91.5|
91615862|NCT00074412|183124944|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|0.988||||0.323||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.||||0.323
91615863|NCT00074412|183124945|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum HIV Infection (%)|2.2|||||TWO_SIDED|95.0|1.1|3.3|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||3.3|1.1|
91615864|NCT00074412|183124945|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum. HIV Infection (%)|3.1|||||TWO_SIDED|95.0|1.9|4.4|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||4.4|1.9|
91615865|NCT00074412|183124945|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.081||||0.28||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.||||0.280
91615866|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.7|||||TWO_SIDED|95.0|2.0|7.4|||Kaplan-Meier Method|||||7.4|2.0|
91615867|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.1|||||TWO_SIDED|95.0|2.7|5.6|||Kaplan-Meier Method|||||5.6|2.7|
91615868|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.247||||0.805||95.0||||P-value was not adjusted for interim analysis or multiple testing|Z-test|||The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.||||0.805
91656548|NCT00406848|183206376|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||.785
91656549|NCT00406848|183206377|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||p-value is for change from baseline (Week 1) to Week 13.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.255
91615869|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.2|||||TWO_SIDED|95.0|0.4|2.0|||Kaplan-Meier Method|||||2.0|0.4|
91615870|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
91615871|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.36||||0.719||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.||||0.719
91615872|NCT00074412|183124946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||95.0|||||Log Rank|||We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.||||0.611
91615873|NCT03656926|183124969|SUPERIORITY|Estimates are from a Linear Mixed Model on the response variable change from baseline in FEV1 with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region (North America vs all other countries together), age (\<55 versus \>=55 years), use of azithromycin at randomization, and time as random effect.|least square mean difference|-0.028||||0.6639|TWO_SIDED|95.0|-0.16|0.104||This is a 1-side p value.|Mixed Models Analysis|||V9 - week 48||0.104|-0.160|0.6639
91615874|NCT02902172|183124972|NON_INFERIORITY||Mean Difference (Net)|0.85|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91615875|NCT00850759|183124974|SUPERIORITY_OR_OTHER||Slope|0.04|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91615876|NCT01773135|183124977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||U statistic|||||||<0.001
91615877|NCT01212172|183125004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.2879|TWO_SIDED|95.0|-6.7|21.1|||t-test, 1 sided|||||21.1|-6.7|0.2879
91615878|NCT00578864|183125006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||95.0|||||Fisher Exact|||||||0.367
91615879|NCT00578864|183125009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0|||||Fisher Exact|||||||0.592
91615880|NCT01253044|183125051|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||MMRM|||||||.912
91527425|NCT00152971|182930102|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|8.4||||0.0009||95.0|3.4|13.3||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.3|3.4|0.0009
91615881|NCT01253044|183125052|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED||||||MMRM|||||||.273
91615882|NCT02262039|183125053|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91615883|NCT02262039|183125054|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
91615884|NCT02262039|183125055|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
91615885|NCT02262039|183125056|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
91656550|NCT00406848|183206377|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.038
91615886|NCT02262039|183125057|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
91615887|NCT02262039|183125058|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
91615888|NCT02262039|183125059|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
91615889|NCT00962000|183125070|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.02217|||TWO_SIDED|95.0|-0.064|0.024||There is no p values because the power calculation is based on the primary outcome variable|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.024|-0.064|
91615890|NCT00962000|183125071|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.01849|||TWO_SIDED|95.0|-0.051|0.023||There is no p value for eKt/V because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.023|-0.051|
91615891|NCT00962000|183125072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03103||||95.0|-0.029|0.099||There is no p value for Kt/VID because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.099|-0.029|
91615892|NCT01519245|183125077|SUPERIORITY_OR_OTHER|||||||0.0493||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of primary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0493
91615893|NCT01519245|183125079|SUPERIORITY_OR_OTHER|||||||0.1876||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.1876
91615894|NCT01519245|183125080|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0930
91615895|NCT02873715|183125081|SUPERIORITY||Mean Difference (Final Values)|-6.21|||<|0.05|TWO_SIDED|95.0|-10.14|-2.29|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.29|-10.14|<0.05
91615896|NCT02873715|183125082|SUPERIORITY||Mean Difference (Final Values)|-3.97||||0.001|TWO_SIDED|95.0|-5.68|-2.26|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.26|-5.68|0.001
91615897|NCT02873715|183125084|SUPERIORITY||Mean Difference (Final Values)|-0.5384||||0.65|TWO_SIDED||||||ANOVA|time x group analysis.||repeated measures analysis of variance for parent delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.65
91615898|NCT02873715|183125084|SUPERIORITY||Mean Difference (Net)|-0.3913||||0.87|TWO_SIDED|||||time x group analysis|ANOVA|||repeated measures analysis of variance for child delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.87
91615899|NCT02144220|183125088|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
91615900|NCT01254396|183125092|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|41.35|||||TWO_SIDED|90.0|32.4|52.76||||||Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||52.76|32.40|
91615901|NCT01254396|183125094|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|93.42|||||TWO_SIDED|90.0|80.23|108.78||||||Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||108.78|80.23|
91527426|NCT00152971|182930103|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.2||||0.2139||95.0|-0.7|3.0|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.0|-0.7|0.2139
91656551|NCT00406848|183206378|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||p-values for Week 13 remission (HAMD17 ≤ 7).|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.706
91656552|NCT00406848|183206378|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-values for Week 25 Remission HAMD17 ≤ 7|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.694
91656553|NCT00406848|183206378|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||p-values for Week 13 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.864
91656554|NCT00406848|183206378|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||p-values for Week 25 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.817
91656555|NCT00406848|183206379|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||p-value is for probability of response at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.664
91656556|NCT00406848|183206379|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for probability of response at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.310
91656557|NCT00406848|183206381|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment\*Visit.||||||0.036
91656558|NCT00406848|183206382|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.637
91656559|NCT00406848|183206382|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
91656560|NCT00406848|183206382|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.452
91656561|NCT00406848|183206382|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.193
91656562|NCT00406848|183206383|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.121
91656563|NCT00406848|183206383|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.038
91656564|NCT00406848|183206384|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Weight change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
91656565|NCT00406848|183206384|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||p-value is for Weight change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.127
91656566|NCT00406848|183206385|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||p-value is for Diastolic Blood Pressure.|Fisher Exact|||||||0.135
91656567|NCT00406848|183206385|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for Pulse.|Fisher Exact|||Pulse||||1.00
91656568|NCT00406848|183206385|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Systolic Blood Pressure|Fisher Exact|||||||0.107
91656569|NCT00406848|183206385|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||p-value is for Weight Change (gain)|Fisher Exact|||||||0.235
91656570|NCT00406848|183206385|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||p-value is for Weight Change (loss)|Fisher Exact|||||||0.813
91656571|NCT00406848|183206386|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||p-value is for Sustained Hypertension|Fisher Exact|||||||0.668
91656572|NCT00406848|183206386|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||p-value is for Orthostatic Hypotension|Fisher Exact|||||||0.201
91656573|NCT00406848|183206388|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 13.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.003
91656574|NCT00406848|183206388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||<0.001
91656575|NCT00406848|183206389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 13.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
91656576|NCT00406848|183206389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
91656577|NCT00406848|183206390|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.014
91656578|NCT00406848|183206391|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Hemoglobin change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.019
91656579|NCT00406848|183206391|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.048
91656580|NCT00406848|183206392|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Chloride change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.040
91656581|NCT00406848|183206392|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.036
91656582|NCT00406848|183206393|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Fisher Exact|||||||0.019
91656583|NCT00406848|183206394|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for QT Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.815
91656584|NCT00406848|183206394|SUPERIORITY_OR_OTHER|||||||0.721||95.0||||p-value is for QTcF Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.721
91656585|NCT00406848|183206394|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p-value is for QTcB Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.376
91656586|NCT00406848|183206394|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||p-value is for PR Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.065
91656587|NCT00406848|183206394|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for QRS Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.110
91656588|NCT00406848|183206395|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.|Fisher Exact|||||||0.110
91656589|NCT00406848|183206395|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.|Fisher Exact|||||||0.016
91656590|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.511
91615902|NCT01254396|183125095|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|87.66|||||TWO_SIDED|90.0|77.62|98.99||||||Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||98.99|77.62|
91615903|NCT04590937|183125107|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.22|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.89|101.67|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.67|94.89|
91527427|NCT00152971|182930103|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.8||||0.3628||95.0|-0.9|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.9|0.3628
91615904|NCT04590937|183125108|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|123.08|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|112.22|134.98|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||134.98|112.22|
91615905|NCT04590937|183125109|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|117.72|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|110.57|125.34|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||125.34|110.57|
91615906|NCT04590937|183125110|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|170.29|STANDARD_ERROR_OF_MEAN|25.6|||TWO_SIDED|90.0|143.73|201.76|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.76|143.73|
91615907|NCT04590937|183125111|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|91.42|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|90.0|88.04|94.93|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||94.93|88.04|
91615908|NCT04590937|183125112|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|139.03|STANDARD_ERROR_OF_MEAN|16.9|||TWO_SIDED|90.0|124.29|155.51|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||155.51|124.29|
91656591|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.300
91656592|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.922
91656593|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.190
91656594|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.850
91656595|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.158
91656596|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.099
91656597|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.141
91656598|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.379
91656599|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.858
91656600|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.591
91656601|NCT00406848|183206396|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.242
91711978|NCT01411852|183315392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.19|19.11|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS).|||19.11|0.19|
91656602|NCT01046253|183206446|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|97.4|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|97.4|
91656603|NCT01046253|183206447|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.5|||||TWO_SIDED|90.0|93.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|93.3|
91656604|NCT01046253|183206448|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|98.0|||||TWO_SIDED|90.0|92.8|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|92.8|
91656605|NCT00860028|183206451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.36||95.0|||||Chi-squared|||||||0.36
91656606|NCT00860028|183206452|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||General Linear Model|||||||0.06
91656607|NCT00860028|183206453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Fisher Exact|||||||0.03
91656608|NCT00936390|183206465|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.22|TWO_SIDED|95.0|0.65|1.11||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|This study was designed to detect an improvement in the 5-year overall survival rate from 90% (radiation alone arm) to 93.3% (radiation and androgen deprivation arm). Assuming an exponential survival distribution for each arm, this translates to a 34% relative reduction (hazard ratio 0.66) in the yearly death rate. At least 218 deaths provide 85% power with a 1-sided significance level of 0.025 and 85% power.||1.11|0.65|0.22
91656609|NCT00936390|183206466|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
91656610|NCT00936390|183206466|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
91656611|NCT00936390|183206467|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.02|TWO_SIDED|95.0|0.22|0.9||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.90|0.22|0.020
91656612|NCT00936390|183206467|SUPERIORITY|Cumulative incidence model||||||0.021||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||||||0.021
91656613|NCT00936390|183206469|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.57||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.57|0.11|<0.001
91527428|NCT00152971|182930104|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.9||||0.2309||95.0|-0.6|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.6|0.2309
91656614|NCT00936390|183206469|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
91656615|NCT00936390|183206470|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0073|TWO_SIDED|95.0|0.01|0.8||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.80|0.01|0.0073
91656616|NCT00936390|183206470|SUPERIORITY|||||||0.007||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.007
91656617|NCT00936390|183206471|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.52|TWO_SIDED|95.0|0.7|1.2||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||1.20|0.70|0.52
91656618|NCT00936390|183206471|SUPERIORITY|||||||0.56||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.56
91656619|NCT00936390|183206472|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.025|TWO_SIDED|95.0|0.41|0.95||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.95|0.41|0.025
91656620|NCT00936390|183206472|SUPERIORITY|||||||0.025||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.025
91656621|NCT00936390|183206474|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91656622|NCT00936390|183206475|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.13|TWO_SIDED|95.0|0.89|1.53||One-sided significance level 0.025 (reported p-value is one-sided)|Gray's test||Reference level = radiation therapy alone arm|||1.53|0.89|0.13
91656623|NCT00936390|183206476|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
91656624|NCT00936390|183206476|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
91656625|NCT00936390|183206477|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||End of RT||||0.38
91656626|NCT00936390|183206477|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||6 months post-RT||||0.032
91656627|NCT00936390|183206477|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||One year post-RT||||0.87
91656628|NCT00936390|183206477|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Five years post-RT||||0.67
91656629|NCT00936390|183206478|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||End of RT||||0.58
91656630|NCT00936390|183206478|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Six months post-RT||||0.31
91656631|NCT00936390|183206478|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||One year post-RT||||0.36
91656632|NCT00936390|183206478|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Five years post-RT||||0.88
91656633|NCT00936390|183206479|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
91656634|NCT00936390|183206479|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
91656635|NCT00936390|183206479|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||One year post-RT||||<0.001
91656636|NCT00936390|183206479|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Five years post-RT||||0.18
91656637|NCT00936390|183206480|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
91656638|NCT00936390|183206480|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
91656639|NCT00936390|183206480|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||One year post-RT||||0.0014
91656640|NCT00936390|183206480|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Five years post-RT||||0.90
91656641|NCT00936390|183206481|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||End of RT||||0.046
91656642|NCT00936390|183206481|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||6 months post-RT||||0.82
91656643|NCT00936390|183206481|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||One year post-RT||||0.82
91656644|NCT00936390|183206481|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Five years post-RT||||0.79
91656645|NCT01566409|183206495|NON_INFERIORITY_OR_EQUIVALENCE|The required sample size was based on a projected treatment success in the PEG group of 60%. With a power in excess of 80% and a critical level of significance of 0.05, 45 children were needed in each group to detect a 50% reduction in treatment effect in the placebo group, corresponding to 30% recovers without active maintenance treatment. Because of an expected drop-out rate of 25%, we aimed at including 115 children.||||||0.024|||||||Regression, Logistic|||||||0.024
91656646|NCT03309956|183206497|SUPERIORITY|||||||0.23|||||||McNemar|||||||0.23
91656647|NCT02768298|183206500|SUPERIORITY||Least Squares (LS) Mean|0.32|STANDARD_ERROR_OF_MEAN|0.268||0.2327|TWO_SIDED|95.0|-0.21|0.85|||ANCOVA|||||0.85|-0.21|0.2327
91656648|NCT02768298|183206501|SUPERIORITY||LS Mean|-0.14|STANDARD_ERROR_OF_MEAN|0.277||0.6247|TWO_SIDED|95.0|-0.68|0.41|||ANCOVA|||||0.41|-0.68|0.6247
91656649|NCT02768298|183206502|SUPERIORITY||LS Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1678|TWO_SIDED|95.0|-2.98|0.52|||ANCOVA|||6 weeks||0.52|-2.98|0.1678
91656650|NCT02768298|183206502|SUPERIORITY||LS Mean|0.83|STANDARD_ERROR_OF_MEAN|0.809||0.3052|TWO_SIDED|95.0|-0.77|2.43|||ANCOVA|||3 months||2.43|-0.77|0.3052
91656651|NCT02768298|183206503|SUPERIORITY||LS Mean|0.87|STANDARD_ERROR_OF_MEAN|1.744||0.6181|TWO_SIDED|95.0|-2.58|4.32|||ANCOVA|||6 weeks||4.32|-2.58|0.6181
91656652|NCT02768298|183206503|SUPERIORITY||LS Mean|3.28|STANDARD_ERROR_OF_MEAN|2.124||0.1254|TWO_SIDED|95.0|-0.93|7.48|||ANCOVA|||3 months||7.48|-0.93|0.1254
91656653|NCT02768298|183206504|SUPERIORITY||LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.317||0.3432|TWO_SIDED|95.0|-0.93|0.33|||ANCOVA|||Borg value dyspnea||0.33|-0.93|0.3432
91656654|NCT02768298|183206504|SUPERIORITY||LS Mean|0.16|STANDARD_ERROR_OF_MEAN|0.251||0.5319|TWO_SIDED|95.0|-0.34|0.65|||ANCOVA|||Borg value fatigue||0.65|-0.34|0.5319
91656655|NCT02518685|183206516|SUPERIORITY||Least-Square Mean Difference|6.7|||<|0.0001|TWO_SIDED|95.0|4.54|8.81|||multiple imputations|||||8.81|4.54|<0.0001
91656656|NCT02518685|183206517|SUPERIORITY|Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up|Proportion of Subjects|66.8|||<|0.0001|TWO_SIDED|95.0|59.3|74.3|||Wilson's Midpoint Estimate|||||74.3|59.3|<0.0001
91656657|NCT00336024|183206536|SUPERIORITY|||||||0.35|||||||Chi-squared|||The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.||||0.35
91656658|NCT00336024|183206538|SUPERIORITY|||||||0.2|||||||Log Rank|||The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.||||0.2
91656659|NCT00336024|183206539|SUPERIORITY|||||||1|||||||Fisher Exact|||The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.||||1.00
91656660|NCT00336024|183206540|SUPERIORITY|||||||0.74|||||||Log Rank|||Difference in incidence for the two treatment regimens will be compared using log-rank test.||||0.74
91656661|NCT00336024|183206541|SUPERIORITY|||||||1|||||||Fisher Exact|||The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.||||1.00
91656662|NCT00336024|183206547|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.||||0.8
91656663|NCT00336024|183206548|SUPERIORITY|||||||0.27|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.27
91656664|NCT00336024|183206548|SUPERIORITY|||||||0.07|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.07
91656665|NCT00336024|183206548|SUPERIORITY|||||||0.2|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.2
91656666|NCT00336024|183206548|SUPERIORITY|||||||0.4|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.4
91656667|NCT00336024|183206548|SUPERIORITY|||||||0.38|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.38
91656668|NCT00336024|183206548|SUPERIORITY|||||||0.7|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.7
91656669|NCT00336024|183206549|SUPERIORITY|||||||0.08|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.08
91615909|NCT04590937|183125113|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|112.1|STANDARD_ERROR_OF_MEAN|15.4|||TWO_SIDED|90.0|101.26|124.11|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||124.11|101.26|
91527429|NCT00152971|182930104|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.5||||0.0602||95.0|-0.1|3.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.2|-0.1|0.0602
91656670|NCT00336024|183206549|SUPERIORITY|||||||0.9|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.9
91656671|NCT00336024|183206549|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
91656672|NCT00336024|183206549|SUPERIORITY|||||||0.3|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.3
91656673|NCT00336024|183206549|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.26
91656674|NCT00336024|183206549|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
91656675|NCT02086188|183206585|SUPERIORITY|||||||0.1911|||||||ANCOVA|||||||0.1911
91656676|NCT02086188|183206586|SUPERIORITY|||||||0.4271|||||||ANCOVA|||||||0.4271
91656677|NCT02086188|183206587|SUPERIORITY|||||||0.1723|||||||ANCOVA|||||||0.1723
91656678|NCT02086188|183206588|SUPERIORITY|||||||0.634|||||||ANCOVA|||||||0.6340
91656679|NCT02086188|183206589|SUPERIORITY|||||||0.0091|||||||ANCOVA|||||||0.0091
91656680|NCT01494506|183206591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9416|TWO_SIDED|95.0|0.77|1.28|||Log Rank|Unstratified logrank test.||||1.28|0.77|0.9416
91656681|NCT01494506|183206591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.012|TWO_SIDED|95.0|0.49|0.92|||Log Rank|Unstratified logrank test.||||0.92|0.49|0.012
91656682|NCT01494506|183206592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.100
91656683|NCT01494506|183206592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.41|0.75|||Log Rank|||||0.75|0.41|<0.001
91656684|NCT01494506|183206593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0264||||0.214|TWO_SIDED|95.0|-0.005|0.058|||Fisher Exact|||||0.058|-0.005|0.214
91656685|NCT01494506|183206593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.01|TWO_SIDED|95.0|0.018|0.12|||Fisher Exact|||||0.120|0.018|0.010
91656686|NCT01494506|183206594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1008|TWO_SIDED|95.0|0.65|1.03|||Log Rank|Unstratified log rank test.||||1.03|0.65|0.1008
91656687|NCT01494506|183206594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.45|0.78|||Log Rank|Unstratified log rank test||||0.78|0.45|0.0002
91656688|NCT01494506|183206595|SUPERIORITY_OR_OTHER|||||||0.82|||||||Fisher Exact|||||||0.82
91656689|NCT01494506|183206595|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.80
91656690|NCT01494506|183206596|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher Exact|||||||0.024
91656691|NCT01494506|183206596|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91656692|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.6388
91656693|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.8445||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.8445
91656694|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.6388
91656695|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.9435||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.9435
91656696|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.2654
91656697|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.7674
91656698|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.1628
91656699|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.6712
91656700|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.7738||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.7738
91656701|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.6712
91656702|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.3408||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.3408
91656703|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.6712
91656704|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6766||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6766
91527430|NCT00152971|182930105|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|5.9||||0.0194||95.0|1.0|10.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.9|1.0|0.0194
91615910|NCT04590937|183125114|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|161.29|STANDARD_ERROR_OF_MEAN|34.1|||TWO_SIDED|90.0|129.17|201.39|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.39|129.17|
91615911|NCT04590937|183125115|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.23|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.86|101.73|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.73|94.86|
91615912|NCT04590937|183125116|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|118.67|STANDARD_ERROR_OF_MEAN|13.0|||TWO_SIDED|90.0|108.83|129.4|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||129.40|108.83|
91615913|NCT04590937|183125117|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|114.07|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|107.93|120.56|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||120.56|107.93|
91615914|NCT04590937|183125118|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|173.77|STANDARD_ERROR_OF_MEAN|30.8|||TWO_SIDED|90.0|141.9|212.8|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||212.80|141.90|
91615915|NCT01544595|183125122|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.42|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.42|0.22|<0.0001
91615916|NCT01544595|183125122|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.29|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.29|0.14|<0.0001
91615917|NCT01929044|183125144|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to the non-inferiority margin of 1|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|Restricted maximum likelihood (REML) -repeated measures approach||0.04|-0.88|<0.0001
91615918|NCT01929044|183125144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23||0.0743|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.04|-0.88|0.0743
91615919|NCT01929044|183125145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.2||0.121|TWO_SIDED|95.0|-0.7|0.08|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.08|-0.70|0.1210
91615920|NCT01929044|183125146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0658|TWO_SIDED|95.0|-0.82|0.03|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.03|-0.82|0.0658
91615921|NCT01929044|183125147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.2||0.022|TWO_SIDED|95.0|-0.85|-0.07|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.07|-0.85|0.0220
91615922|NCT01929044|183125148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0149|TWO_SIDED|95.0|-0.81|-0.09|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.09|-0.81|0.0149
91615923|NCT01929044|183125149|SUPERIORITY_OR_OTHER|||||||0.0113|||||||van Elteren test|The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.||||||0.0113
91656705|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6712
91656706|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.6388
91656707|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.7674
91656708|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.4993||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.4993
91656709|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.6712
91656710|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.2654
91656711|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.6712
91656712|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.7617
91656713|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712|||||||Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.6712
91711979|NCT01411852|183315393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.22|1.77|||||Adjusted for age (linear spline with knot at 45 years), penetrating mechanism (yes/no), and ISS (linear).|||1.77|0.22|
91711980|NCT03193047|183315397|SUPERIORITY||Least squares mean difference|-30.261|STANDARD_ERROR_OF_MEAN|5.502|<|0.001|TWO_SIDED|95.0|-41.324|-19.199|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-19.199|-41.324|<0.001
91656714|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.9123||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.9123
91656715|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.6712
91656716|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.7617
91656717|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.6712
91656718|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.1628
91656719|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.6712
91656720|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.6388
91656721|NCT01494506|183206597|SUPERIORITY_OR_OTHER|||||||0.7308||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.7308
91656722|NCT02777528|183206604|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.60, then the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.745|||||TWO_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 1-Month imaging performed.~Results were tested against a performance goal (PG) of 0.60 (i.e. 60%), derived from outcomes from a systematic review of hybrid TEVAR repair literature.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 50 patients."||||
91656723|NCT01882647|183206623|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
91656724|NCT01882647|183206624|SUPERIORITY_OR_OTHER||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
91656725|NCT01882647|183206625|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.01
91656726|NCT01882647|183206626|SUPERIORITY_OR_OTHER||||||<|0.01||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.01
91656727|NCT01108094|183206629|OTHER|||||||0.04|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.04
91711981|NCT03193047|183315398|SUPERIORITY||Lease squares mean difference|-35.884|STANDARD_ERROR_OF_MEAN|5.159|<|0.001|TWO_SIDED|95.0|-46.303|-25.466|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-25.466|-46.303|<0.001
91711982|NCT03193047|183315399|SUPERIORITY||Least squares mean difference|-38.25|STANDARD_ERROR_OF_MEAN|5.602|<|0.001|TWO_SIDED|95.0|-49.558|-26.944|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 1||-26.944|-49.558|<0.001
91656728|NCT01108094|183206629|OTHER|||||||0.079|||||||t-test, 1 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.079
91656729|NCT01108094|183206629|OTHER|||||||0.652|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month."||||0.652
91656730|NCT01108094|183206630|OTHER|||||||0.028|||||||t-test, 2 sided|||"Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment."|Wilcoxon signed rank test|||0.028
91656731|NCT01108094|183206631|OTHER||Mean Difference (Final Values)|24.0|||||TWO_SIDED|95.0|18.2|30.0||||||Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.||30|18.2|
91656732|NCT01108094|183206631|OTHER|||||||0.435|||||||t-test, 1 sided|||Average tumor size reductions were compared between Cohort A1 and Cohort B.||||0.435
91656733|NCT02564263|183206667|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00894|TWO_SIDED|95.0|0.63|0.96||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||0.96|0.63|0.00894
91656734|NCT02564263|183206668|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.00855|TWO_SIDED|95.0|0.52|0.94||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||0.94|0.52|0.00855
91711983|NCT03193047|183315399|SUPERIORITY||Least squares mean difference|-29.9|STANDARD_ERROR_OF_MEAN|5.606|<|0.001|TWO_SIDED|95.0|-41.176|-18.626|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 2||-18.626|-41.176|<0.001
91711984|NCT03193047|183315400|SUPERIORITY||Least squares mean difference|-27.031|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-37.509|-16.553|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 1||-16.553|-37.509|<0.001
91527431|NCT00152971|182930105|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|8.9||||0.0004||95.0|4.0|13.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.9|4.0|0.0004
91527432|NCT00152971|182930106|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5774
91615924|NCT01929044|183125150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0992|TWO_SIDED|95.0|0.37|1.09|||Regression, Logistic|A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.|Exact 95% confidence interval obtained by Clopper and Pearson approach.|||1.09|0.37|0.0992
91615925|NCT00554294|183125151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.05||95.0|0.48|0.98|||Regression, Logistic|The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).||adjusted for overweight at baseline, age at baseline,sex and clustering by school||0.98|0.48|<0.05
91615926|NCT05022004|183125156|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-0.28|0.91|||||The reported mean difference represents value for Left Eye at Week 2, 08:00am|||0.91|-0.28|
91615927|NCT05022004|183125156|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||The reported mean difference represents value for Right Eye at Week 2, 08:00am|||0.76|-0.39|
91656735|NCT02564263|183206669|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0531|TWO_SIDED|95.0|0.75|1.05||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||1.05|0.75|0.0531
91656736|NCT02564263|183206670|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.287|TWO_SIDED|95.0|0.94|1.31||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||1.31|0.94|0.287
91656737|NCT02564263|183206671|SUPERIORITY||Difference in Percentages|6.4||||0.0037|TWO_SIDED|95.0|1.7|11.2||One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||11.2|1.7|0.0037
91656738|NCT02564263|183206672|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.216|TWO_SIDED|95.0|0.75|1.13||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||1.13|0.75|0.216
91656739|NCT02564263|183206673|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.015|TWO_SIDED|95.0|0.54|0.97||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||0.97|0.54|0.015
91711985|NCT03193047|183315400|SUPERIORITY||Least squares mean difference|-24.469|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-33.225|-15.713|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 2||-15.713|-33.225|<0.001
91615928|NCT05022004|183125156|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.59|0.5|||||The reported mean difference represents value for Left Eye at Week 6, 08:00am|||0.50|-0.59|
91527433|NCT00152971|182930106|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91527434|NCT00152971|182930107|SUPERIORITY_OR_OTHER|||||||0.7724||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.7724
91527435|NCT00152971|182930107|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0308
91615929|NCT05022004|183125156|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.64|0.4|||||The reported mean difference represents value for Right Eye at Week 6, 08:00am|||0.40|-0.64|
91656740|NCT02564263|183206674|SUPERIORITY||Difference in Percentages|9.2||||0.0022|TWO_SIDED|95.0|3.0|15.8||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW)|||15.8|3.0|0.0022
91656741|NCT02564263|183206675|SUPERIORITY||Difference in Percentages|15.1||||0.0006|TWO_SIDED|95.0|6.2|24.7||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||24.7|6.2|0.0006
91656742|NCT02906709|183206678|SUPERIORITY||Difference in the Least Squares Means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.15|-0.66|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior anti-hyperglycemic agent (AHA) therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-0.66|-1.15|<0.001
91656743|NCT02906709|183206679|SUPERIORITY||Difference in % vs. Placebo|7.0|||||TWO_SIDED|95.0|-8.4|21.8|||||||Based on Miettinen \& Nurminen method.|21.8|-8.4|
91656744|NCT02906709|183206681|SUPERIORITY||Difference in % vs. Placebo|-4.1|||||TWO_SIDED|95.0|-12.8|0.4|||||||Based on Miettinen \& Nurminen method.|0.4|-12.8|
91656745|NCT02906709|183206683|SUPERIORITY||Difference in the Least Squares Means|-15.0||||0.002|TWO_SIDED|95.0|-24.5|-5.4|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-5.4|-24.5|0.002
91656746|NCT02906709|183206684|SUPERIORITY||Percent Between-group Rate Difference|5.8||||0.065|TWO_SIDED|95.0|-0.7|11.5|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|11.5|-0.7|0.065
91656747|NCT02906709|183206685|SUPERIORITY||Percent Between-group Rate Difference|1.6||||0.334|TWO_SIDED|95.0|-4.7|5.8|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|5.8|-4.7|0.334
91656748|NCT02906709|183206686|SUPERIORITY||Difference in the Least Squares Means|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.0|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|4.0|2.3|<0.001
91656749|NCT02419313|183206691|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Fisher Exact|||||||0.0007
91656750|NCT02419313|183206692|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Fisher Exact|||||||0.0008
91656751|NCT02419313|183206693|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||||||0.0105
91656752|NCT00683020|183206695|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|0.9||0.03|TWO_SIDED|95.0|0.1|3.9|||Regression, Linear|Adjusted for baseline values.||||3.9|0.1|0.03
91656753|NCT00683020|183206696|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.23|TWO_SIDED|95.0|-0.9|3.6|||Regression, Linear|Adjusted for baseline values.||||3.6|-0.9|0.23
91656754|NCT00683020|183206697|NON_INFERIORITY_OR_EQUIVALENCE|Days in comparison groups are not equal.|Rate Ratio|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Negative Binomial Models|Adjusted for baseline values.||||1.4|0.3|0.25
91656755|NCT00683020|183206698|NON_INFERIORITY_OR_EQUIVALENCE|Proportions in comparison groups are not equal.|Odds Ratio (OR)|0.5||||0.18|TWO_SIDED|95.0|0.2|1.4|||Regression, Logistic|Adjusted for baseline values.||||1.4|0.2|0.18
91656756|NCT00683020|183206699|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|Adjusted for baseline values.||||0.5|0.1|0.008
91656757|NCT00683020|183206700|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.87|TWO_SIDED|95.0|-0.2|0.2|||Regression, Linear|Adjusted for baseline values.||||0.2|-0.2|0.87
91656758|NCT00683020|183206701|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.6||0.49|TWO_SIDED|95.0|-2.1|4.2|||Regression, Linear|Adjusted for baseline values.||||4.2|-2.1|0.49
91656759|NCT00683020|183206702|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.2||0.54|TWO_SIDED|95.0|-3.0|5.6|||Regression, Linear|Adjusted for baseline values.||||5.6|-3.0|0.54
91656760|NCT00683020|183206703|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED|95.0|-0.4|4.4|||Regression, Linear|Adjusted for baseline values.||||4.4|-0.4|0.11
91656761|NCT00683020|183206704|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED|95.0|-0.6|0.1|||Regression, Linear|Adjusted for baseline values.||||0.1|-0.6|0.13
91656762|NCT00683020|183206705|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.3||0.78|TWO_SIDED|95.0|-3.8|5.1|||Regression, Linear|Adjusted for baseline values.||||5.1|-3.8|0.78
91656763|NCT00683020|183206706|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.13|TWO_SIDED|95.0|-0.6|4.9|||Regression, Linear|Adjusted for baseline values.||||4.9|-0.6|0.13
91656764|NCT02319148|183206744|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|105.28|||||TWO_SIDED|90.0|92.11|120.34|||Mixed Models Analysis|||||120.34|92.11|
91524274|NCT04022889|182923717|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|25.5|STANDARD_DEVIATION|25.3|||TWO_SIDED|95.0|9.5|41.6|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||41.6|9.5|
91656765|NCT02319148|183206744|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.54|||||TWO_SIDED|90.0|80.96|105.77|||Mixed Models Analysis|||||105.77|80.96|
91656766|NCT02319148|183206744|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|116.36|||||TWO_SIDED|90.0|101.86|132.92|||Mixed Models Analysis|||||132.92|101.86|
91656767|NCT02319148|183206745|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.16|||||TWO_SIDED|90.0|78.57|103.46|||Mixed Models Analysis|||||103.46|78.57|
91527436|NCT00152971|182930108|SUPERIORITY_OR_OTHER|||||||0.4968||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4968
91656768|NCT02319148|183206745|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.38|||||TWO_SIDED|90.0|92.7|122.07|||Mixed Models Analysis|||||122.07|92.70|
91656769|NCT02319148|183206745|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.71|||||TWO_SIDED|90.0|88.68|116.66|||Mixed Models Analysis|||||116.66|88.68|
91656770|NCT02319148|183206746|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.33|||||TWO_SIDED|90.0|79.49|104.94|||Mixed Models Analysis|||||104.94|79.49|
91656771|NCT02319148|183206746|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.97|||||TWO_SIDED|90.0|93.1|122.91|||Mixed Models Analysis|||||122.91|93.10|
91656772|NCT02319148|183206746|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.69|||||TWO_SIDED|90.0|89.42|117.93|||Mixed Models Analysis|||||117.93|89.42|
91656773|NCT00048048|183206765|SUPERIORITY_OR_OTHER||Least square mean|0.979|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|95.0|0.534|1.425|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ Week||1.425|0.534|
91656774|NCT00048048|183206765|SUPERIORITY_OR_OTHER||Least square mean|0.851|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.395|1.307|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ 2Week||1.307|0.395|
91656775|NCT00048048|183206765|SUPERIORITY_OR_OTHER||Least square mean|0.932|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.488|1.377|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X /3 Week||1.377|0.488|
91656776|NCT00771537|183206811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|95.0|0.5|0.96|||Regression, Logistic||Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).|||.96|.50|0.05
91656777|NCT00771537|183206811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|0.54|1.04|||Regression, Logistic||Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).|||1.04|.54|.10
91656778|NCT00771537|183206811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.176||0.63|TWO_SIDED|95.0|0.65|1.3|||Regression, Logistic||Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)|||1.30|.65|.63
91656779|NCT00771537|183206812|SUPERIORITY_OR_OTHER||Marginal Means|2.49|STANDARD_ERROR_OF_MEAN|0.037|<|0.6|TWO_SIDED|95.0|2.42|2.56|||ANOVA|Degrees of freedom = (1,978)|There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-way Analysis of Variance||2.56|2.42|<.60
91656780|NCT00771537|183206812|SUPERIORITY_OR_OTHER||Marginal Means|2.51|STANDARD_ERROR_OF_MEAN|0.036|<|0.25|TWO_SIDED|95.0|2.44|2.58|||ANOVA|degrees of freedom = (1,1028)|There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.58|2.44|<.25
91656781|NCT00771537|183206812|SUPERIORITY_OR_OTHER||Marginal Means|2.47|STANDARD_ERROR_OF_MEAN|0.036|<|0.91|TWO_SIDED|95.0|2.4|2.54|||ANOVA||There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.54|2.40|<.91
91656782|NCT02194998|183206813|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR12 rate \<= 70%.||||<0.01
91656783|NCT02194998|183206813|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR12 rate \<= 70%.||||0.47
91656784|NCT02194998|183206813|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR12 rate \<= 70%.||||<0.01
91656785|NCT02194998|183206813|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR12 rate \<= 70%.||||0.24
91656786|NCT02194998|183206826|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR24 rate \<= 70%.||||<0.01
91656787|NCT02194998|183206826|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR24 rate \<= 70%.||||0.47
91656788|NCT02194998|183206826|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR24 rate \<= 70%.||||<0.01
91615930|NCT05022004|183125157|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0015||||||P value reported for Left Eye at Week 2; 08:00 am|two-sample t-test|||||||0.0015
91615931|NCT05022004|183125157|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0008|||||||two-sample t-test|P value reported for Right Eye at Week 2; 08:00am||||||0.0008
91615932|NCT05022004|183125157|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for left eye at week 6, 08:00 am||||||<.0001
91615933|NCT05022004|183125157|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for Right eye at Week 6; 08:00 am||||||<.0001
91615934|NCT01128972|183125188|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|7.09|16.24||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||16.24|7.09|<0.0001
91615935|NCT01128972|183125188|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|26.6|||<|0.0001|TWO_SIDED|95.0|22.02|31.18||No adjustments made for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||31.18|22.02|<0.0001
91615936|NCT01128972|183125188|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.17|||<|0.0001|TWO_SIDED|95.0|32.59|41.74||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||41.74|32.59|<0.0001
91656789|NCT02194998|183206826|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR24 rate \<= 70%.||||0.24
91656790|NCT00282256|183206829|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for AUC0-24 was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|100.9|||||TWO_SIDED|90.0|90.8|112.1|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||112.1|90.8|
91656791|NCT00282256|183206831|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for Cmin was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|91.8|||||TWO_SIDED|90.0|82.6|102.2|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||102.2|82.6|
91524275|NCT04022889|182923717|EQUIVALENCE|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|21.3|||TWO_SIDED|95.0|-12.7|15.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||15.8|-12.7|
91615937|NCT01128972|183125189|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.11||||0.0083|TWO_SIDED|95.0|1.07|7.15||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||7.15|1.07|0.0083
91711986|NCT03193047|183315400|SUPERIORITY||Least squares mean difference|-31.64|STANDARD_ERROR_OF_MEAN|4.689|<|0.001|TWO_SIDED|95.0|-41.116|-22.163|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 1||-22.163|-41.116|<0.001
91615938|NCT01128972|183125189|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.25|||<|0.0001|TWO_SIDED|95.0|8.22|14.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.29|8.22|<0.0001
91615939|NCT01128972|183125189|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.56|||<|0.0001|TWO_SIDED|95.0|8.53|14.6||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.60|8.53|<0.0001
91615940|NCT01128972|183125190|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88||||0.7041|TWO_SIDED|95.0|-5.46|3.69||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||3.69|-5.46|0.7041
91615941|NCT01128972|183125190|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.78|||<|0.0001|TWO_SIDED|95.0|6.21|15.36||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||15.36|6.21|<0.0001
91615942|NCT01128972|183125190|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|25.72|||<|0.0001|TWO_SIDED|95.0|21.14|30.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||30.29|21.14|<0.0001
91615943|NCT01128972|183125190|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|36.29|||<|0.0001|TWO_SIDED|95.0|31.71|40.86||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||40.86|31.71|<0.0001
91615944|NCT01128972|183125191|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.39||||0.0049|TWO_SIDED|95.0|-7.43|-1.35||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-1.35|-7.43|0.0049
91615945|NCT01128972|183125191|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.8571|TWO_SIDED|95.0|-3.31|2.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||2.76|-3.31|0.8571
91615946|NCT01128972|183125191|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.87|||<|0.0001|TWO_SIDED|95.0|3.83|9.9||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||9.90|3.83|<0.0001
91656792|NCT01345019|183206847|NON_INFERIORITY|A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.|Hazard Ratio (HR)|0.98||||0.01|TWO_SIDED|95.0|0.85|1.14|||Cox proportional hazards model|Based on a Cox proportional hazards model stratified by the randomization stratification factors.|A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab|||1.14|0.85|0.010
91711987|NCT03193047|183315400|SUPERIORITY||Least squares mean difference|-24.246|STANDARD_ERROR_OF_MEAN|4.838|<|0.001|TWO_SIDED|95.0|-33.987|-14.505|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 2||-14.505|-33.987|<0.001
91527437|NCT00152971|182930108|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91656793|NCT01345019|183206850|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.||||||0.82|||||||Log Rank|Based on a log rank test stratified by randomization stratification factors.||||||0.82
91615947|NCT01128972|183125191|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.17|||<|0.0001|TWO_SIDED|95.0|4.14|10.21||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.21|4.14|<0.0001
91615948|NCT01128972|183125192|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.94|||||TWO_SIDED|95.0|10.36|19.51||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||19.51|10.36|
91615949|NCT01128972|183125193|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.14|||<|0.0001|TWO_SIDED|95.0|4.11|10.18||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.18|4.11|<0.0001
91615950|NCT01678807|183125194|SUPERIORITY_OR_OTHER||Percent Difference|13.8|||||TWO_SIDED|95.0|-3.4|30.3|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||30.3|-3.4|
91615951|NCT01678807|183125194|SUPERIORITY_OR_OTHER||Percent Difference|10.8|||||TWO_SIDED|95.0|-6.4|27.4|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||27.4|-6.4|
91615952|NCT01678807|183125195|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
91615953|NCT01678807|183125195|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
91615954|NCT05281523|183125196|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.6||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.2|-1.0|0.004
91615955|NCT05281523|183125197|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group.|Difference in Least Square Means|-0.25||||0.025|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.03|-0.46|0.025
91615956|NCT05281523|183125198|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group.|Difference in Least Square Means|-0.18||||0.125|TWO_SIDED|95.0|-0.4|0.05|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.05|-0.40|0.125
91615957|NCT05281523|183125199|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.26||||0.007|TWO_SIDED|95.0|-0.45|-0.07|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||-0.07|-0.45|0.007
91656794|NCT01345019|183206851|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.|Rate ratio|1.01||||0.84|TWO_SIDED|95.0|0.89|1.15|||Andersen-Gill model|Based on an Andersen-Gill model stratified by the randomization stratification factors.|A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|||1.15|0.89|0.84
91656795|NCT01345019|183206853|SUPERIORITY|If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.|Hazard Ratio (HR)|0.9||||0.41|TWO_SIDED|95.0|0.7|1.16|||Cox proportional hazards model||A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.||1.16|0.70|0.41
91656796|NCT00497796|183206881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on the ICH guidance, the hypothesis of non-inferiority can be tested using a one-sided 97.5% confidence interval's (CI) upper bound comparing with the non-inferiority margin of 5% (0.05).|Rate difference|0.041|||||TWO_SIDED|95.0|-0.038|0.119|||||Rate difference is the rate of maribavir minus the rate of ganciclovir|||0.119|-0.038|
91656797|NCT00497796|183206881|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.586||||0.2754|TWO_SIDED|95.0|0.682|3.69||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||3.690|0.682|0.2754
91656798|NCT00497796|183206882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.793||||0.0283|TWO_SIDED|95.0|1.065|3.02||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of the pp65 antigenemia assay||3.020|1.065|0.0283
91656799|NCT00497796|183206882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.284||||0.0024|TWO_SIDED|95.0|1.338|3.9|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||3.900|1.338|0.0024
91656800|NCT00497796|183206882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.177||||0.0053|TWO_SIDED|95.0|1.259|3.767||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||3.767|1.259|0.0053
91656801|NCT00497796|183206882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.388||||0.2339|TWO_SIDED|95.0|0.811|2.377||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||2.377|0.811|0.2339
91615958|NCT05281523|183125200|OTHER|Analysis performed using an analysis of covariance model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region and previous surgery for nasal polyps. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level|Difference in Least Square Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-2.0|||ANCOVA|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-4.4|<0.001
91615959|NCT05281523|183125201|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-9.9||||0.015|TWO_SIDED|95.0|-17.9|-2.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-17.9|0.015
91615960|NCT05281523|183125202|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.24||||0.016|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 21 to Week 24 in participants with a diagnosis of CRSwNP||-0.04|-0.43|0.016
91615961|NCT05281523|183125203|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.3||||0.066|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 26 in participants with a diagnosis of CRSwNP||0.0|-0.7|0.066
91656802|NCT00497796|183206883|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Hazard Ratio|2.25|||<|0.0001|TWO_SIDED|95.0|1.62|3.14|||Log Rank||Maribavir versus ganciclovir; Cox's proportional hazards regression model: time = receipt of induction ALA and geographic region (US or Europe) + treatment.|Analysis of time to onset||3.14|1.62|<0.0001
91656803|NCT00497796|183206884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.0008
91656804|NCT00497796|183206884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3742|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.3742
91656805|NCT00497796|183206885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||||0.0007
91656806|NCT00497796|183206886|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.041|||<|0.0001|TWO_SIDED|95.0|2.179|7.494||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia assay||7.494|2.179|<0.0001
91656807|NCT00497796|183206886|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.448|||<|0.0001|TWO_SIDED|95.0|3.404|12.213||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||12.213|3.404|<0.0001
91656808|NCT00497796|183206886|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.02|||<|0.0001|TWO_SIDED|95.0|3.342|10.843||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||10.843|3.342|<0.0001
91527438|NCT00152971|182930110|SUPERIORITY_OR_OTHER|||||||0.1416||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1416
91527439|NCT00152971|182930110|SUPERIORITY_OR_OTHER|||||||0.0942||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0942
91615962|NCT05281523|183125204|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses.|Hazard Ratio (HR)|0.735||||0.128|TWO_SIDED|95.0|0.495|1.092|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.092|0.495|0.128
91615963|NCT05281523|183125205|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.713||||0.146|TWO_SIDED|95.0|0.453|1.124|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.124|0.453|0.146
91615964|NCT05281523|183125206|OTHER|Logistic regression with covariates of treatment, number of courses of systemic CS in 12 months prior to screening for NP (0, 1,\>1), log(e) baseline blood eosinophil count, baseline total endoscopic NP score, baseline nasal obstruction score (VRS), region, study and previous surgery for NPs. The study covariate is removed for individual study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Odds Ratio (OR)|0.58||||0.006|TWO_SIDED|95.0|0.4|0.86|||Regression, Logistic|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||0.86|0.40|0.006
91615965|NCT05281523|183125207|OTHER|The pooled statistical analyses was performed using a Mixed Models Repeated Measures (MMRM) model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, study, visit and interaction terms for visit by baseline score and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.75||||0.004|TWO_SIDED|95.0|-1.26|-0.25|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis).||-0.25|-1.26|0.004
91615966|NCT02574312|183125208|NON_INFERIORITY|Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.||||||0.028|||||||t-test, 1 sided|||||||0.028
91615967|NCT04467164|183125221|SUPERIORITY|||||||0.03|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the subgenual anterior cingulate cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.03
91615968|NCT04467164|183125221|SUPERIORITY|||||||0.022|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the orbitofrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.022
91615969|NCT04467164|183125221|SUPERIORITY|||||||0.027|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the ventromedial prefrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.027
91615970|NCT04467164|183125222|SUPERIORITY|||||||0.03|||||||ANOVA|||Null hypothesis is that there was no difference in the change in BDI scale score between exhalatory-gated tVNS and inhalatory-gated tVNS. A repeated measures ANOVA controlled by baseline values was used to test this difference. A p\<0.05 was designated for statistical significance. A positive difference indicates an increase in depressive symptomatology, whereas a negative difference indicates a reduction in depressive symptoms.||||0.03
91615971|NCT04467164|183125223|SUPERIORITY|||||||0.01|||||||Regression, Linear|||The null hypothesis is that there were no differences in percent HFn changes post-pre stimulation between exhalatory-gated and inhalatory-gated tVNS. A General Linear Model (GLM) analysis adjusted by baseline values was used for evaluating differences in this measure between treatment groups. A p\<0.05 was designated for statistical significance. A positive percent change value indicates an increase in cardiovagal activity, whereas a negative change indicates a reduction in cardiovagal activity.||||0.01
91615972|NCT03463941|183125229|OTHER||||||||||||||||||descriptive|||
91615973|NCT03463941|183125230|OTHER||||||||||||||||||descriptive|||
91615974|NCT03463941|183125232|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91615975|NCT03463941|183125233|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91615976|NCT03463941|183125234|OTHER||||||||||||||||||descriptive|||
91711988|NCT03193047|183315400|SUPERIORITY||Least squares mean difference|-21.941|STANDARD_ERROR_OF_MEAN|3.572|<|0.001|TWO_SIDED|95.0|-29.153|-14.729|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 1||-14.729|-29.153|<0.001
91615977|NCT03463941|183125235|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91615978|NCT02273050|183125236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.885|STANDARD_ERROR_OF_MEAN|0.0994|<|0.001|TWO_SIDED|95.0|-1.08|-0.689|||ANCOVA|||||-0.689|-1.080|<0.001
91615979|NCT02273050|183125236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.1005||0.034|TWO_SIDED|95.0|-0.41|-0.016|||ANCOVA|||||-0.016|-0.410|0.034
91527440|NCT04091360|182930115|OTHER||GeoMean Ratio|1.221|||<|0.0001|TWO_SIDED|95.0|1.163|1.281|||ANCOVA|||||1.281|1.163|<0.0001
91527441|NCT04091360|182930115|OTHER||GeoMean Ratio|1.203|||<|0.0001|TWO_SIDED|95.0|1.146|1.263|||ANCOVA|||||1.263|1.146|<0.0001
91615980|NCT02273050|183125237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.5|||<|0.001|TWO_SIDED|95.0|29.0|46.0|||Fisher Exact|||||46.0|29.0|<0.001
91615981|NCT02273050|183125237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7||||0.011|TWO_SIDED|95.0|2.6|18.9|||Fisher Exact|||||18.9|2.6|0.011
91711989|NCT03193047|183315400|SUPERIORITY||Least squares mean difference|-17.52|STANDARD_ERROR_OF_MEAN|3.809|<|0.001|TWO_SIDED|95.0|-25.201|-9.839|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 2||-9.839|-25.201|<0.001
91615982|NCT02273050|183125238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39|STANDARD_ERROR_OF_MEAN|0.158|<|0.001|TWO_SIDED|95.0|-1.7|-1.08|||ANCOVA|||||-1.08|-1.70|<0.001
91615983|NCT02273050|183125238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159||0.046|TWO_SIDED|95.0|-0.63|0.0|||ANCOVA|||||0.00|-0.63|0.046
91615984|NCT02273050|183125239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-416.0|STANDARD_ERROR_OF_MEAN|51.54|<|0.001|TWO_SIDED|95.0|-517.3|-314.6|||ANCOVA|||||-314.6|-517.3|<0.001
91615985|NCT02273050|183125239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-169.3|STANDARD_ERROR_OF_MEAN|52.05||0.001|TWO_SIDED|95.0|-271.7|-66.9|||ANCOVA|||||-66.9|-271.7|0.001
91615986|NCT02273050|183125240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.9|||<|0.001|TWO_SIDED|95.0|26.0|43.9|||Fisher Exact|||||43.9|26.0|<0.001
91615987|NCT02273050|183125240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.6||||0.02|TWO_SIDED|95.0|2.3|20.9|||Fisher Exact|||||20.9|2.3|0.020
91615988|NCT02273050|183125241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-3.7|-2.25|||ANCOVA|||||-2.25|-3.70|<0.001
91615989|NCT02273050|183125241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.374||0.002|TWO_SIDED|95.0|-1.88|-0.41|||ANCOVA|||||-0.41|-1.88|0.002
91615990|NCT02273050|183125242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-13.3|-4.5|||Fisher Exact|||||-4.5|-13.3|<0.001
91615991|NCT02273050|183125242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-2.3|2.3|||Fisher Exact|||||2.3|-2.3|>0.999
91615992|NCT00903032|183125251|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.003|TWO_SIDED||||||Chi-squared|||Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.||||0.003
91615993|NCT04346628|183125294|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.24|TWO_SIDED|95.0|0.48|1.2||The final test was performed at the alpha = 0.04999 level of significance, adjusted for age group and sex.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|||1.20|0.48|0.24
91615994|NCT04346628|183125296|SUPERIORITY|||||||0.06||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in hospitalizations||||0.06
91615995|NCT04346628|183125296|SUPERIORITY|||||||0.56||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in ED visits||||0.56
91615996|NCT04346628|183125298|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.43|TWO_SIDED|95.0|0.54|1.29||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until initial resolution of symptoms||1.29|0.54|0.43
91615997|NCT04346628|183125298|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until sustained resolution of symptoms||1.45|0.52|0.59
91615998|NCT01763905|183125302|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.06|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-43.73|-32.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.99|-43.73|<0.001
91615999|NCT01763905|183125302|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-42.16|-32.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.94|-42.16|<0.001
91616000|NCT01763905|183125303|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.3|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-77.9|-54.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.7|-77.9|<0.001
91616001|NCT01763905|183125303|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-80.5|-60.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-60.7|-80.5|<0.001
91527442|NCT04091360|182930115|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.085|1.195|||ANCOVA|||||1.195|1.085|<0.0001
91616002|NCT01763905|183125304|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.7|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-82.0|-57.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-57.5|-82.0|<0.001
91616003|NCT01763905|183125304|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-79.2|-58.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-58.4|-79.2|<0.001
91527443|NCT04091360|182930116|OTHER||GeoMean Ratio|1.253|||<|0.0001|TWO_SIDED|95.0|1.151|1.363|||ANCOVA|||||1.363|1.151|<0.0001
91527444|NCT04091360|182930116|OTHER||GeoMean Ratio|1.146||||0.0022|TWO_SIDED|95.0|1.054|1.246|||ANCOVA|||||1.246|1.054|0.0022
91656809|NCT00497796|183206886|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.165|||<|0.0001|TWO_SIDED|95.0|4.146|30.069||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||30.069|4.146|<0.0001
91656810|NCT00832377|183207033|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 peak IOP vs. baseline|paired t-test|||||||<0.0001
91656811|NCT00832377|183207034|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 trough IOP vs. baseline|paired t-test|||||||<0.0001
91656812|NCT00832377|183207035|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 8-HR IOP vs. baseline|paired t-test|||||||<0.0001
91656813|NCT03661528|183207038|OTHER||Percentage proportion difference|13.4||||0.0032|TWO_SIDED|95.0|4.6|22.2|||Cochran-Mantel-Haenszel|||||22.2|4.6|0.0032
91656814|NCT03661528|183207039|OTHER||Difference in least squares mean|-185.99|||<|0.0001|TWO_SIDED|95.0|-199.93|-172.05|||ANCOVA|Analysis presented for ANCOVA based on ranks.||||-172.05|-199.93|<0.0001
91656815|NCT03249584|183207040|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.||||<0.0001
91656816|NCT03130699|183207078|SUPERIORITY|||||||0.95|||||||Regression, Logistic|||Analyses controlled for age, gender, employment and language.||||0.95
91656817|NCT03130699|183207079|SUPERIORITY|||||||0.37|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.37
91656818|NCT03130699|183207080|SUPERIORITY|||||||0.26|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.26
91711990|NCT03193047|183315401|SUPERIORITY||Median treatment difference|-32.479|STANDARD_ERROR_OF_MEAN|17.395||0.046|TWO_SIDED|95.0|-70.524|-2.339|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 1||-2.339|-70.524|0.046
91527445|NCT04091360|182930116|OTHER||GeoMean Ratio|1.102||||0.0295|TWO_SIDED|95.0|1.01|1.202|||ANCOVA|||||1.202|1.010|0.0295
91656819|NCT03130699|183207081|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.90
91656820|NCT03130699|183207082|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.21
91656821|NCT03130699|183207083|SUPERIORITY|||||||0.3|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.30
91656822|NCT03130699|183207084|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for income.||||0.90
91656823|NCT03130699|183207085|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||Analyses controlled for income.||||0.72
91656824|NCT03130699|183207086|SUPERIORITY|||||||0.61|||||||Regression, Logistic|||Analyses controlled for income.||||0.61
91656825|NCT03130699|183207087|SUPERIORITY|||||||0.49|||||||Regression, Logistic|||Analyses controlled for income.||||0.49
91656826|NCT03130699|183207088|SUPERIORITY|||||||0.96|||||||Regression, Logistic|||Analyses controlled for income.||||0.96
91656827|NCT03130699|183207089|SUPERIORITY|||||||0.64|||||||Regression, Logistic|||Analyses controlled for income.||||0.64
91656828|NCT03130699|183207090|SUPERIORITY|||||||0.87|||||||Regression, Logistic|||Binary logistic analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.87
91656829|NCT03130699|183207091|SUPERIORITY|||||||0.58|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.58
91656830|NCT03130699|183207092|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.25
91656831|NCT03130699|183207093|SUPERIORITY|||||||0.11|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.11
91656832|NCT03130699|183207094|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||Analyses controlled for income.||||0.76
91656833|NCT03130699|183207095|SUPERIORITY|||||||0.05|||||||Regression, Logistic|||Analyses controlled for income.||||0.05
91656834|NCT03130699|183207096|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses controlled for income.||||0.63
91656835|NCT03130699|183207097|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses is controlled for income.||||0.63
91656836|NCT03130699|183207098|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||Analyses controlled for income.||||0.002
91656837|NCT03130699|183207099|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||Analyses controlled for income.||||0.008
91656838|NCT00977470|183207133|EQUIVALENCE|All enrolled patients will be included in the intent-to-treat efficacy analyses. Based on historical patients with EGFR mutations treated with gefitinib, we expect median progression-free survival on the erlotinib-alone arm to be approximately 9 months. This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus HCQ arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test.||||||0.28|||||||Log Rank|||||||0.28
91656839|NCT00796822|183207145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_DEVIATION|1.09||0.44|TWO_SIDED|95.0|-1.53|3.28|||t-test, 2 sided|||The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.||3.28|-1.53|0.44
91656840|NCT00796822|183207146|SUPERIORITY|There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.|Median Difference (Net)|149.1|STANDARD_DEVIATION|151.8||0.03|TWO_SIDED|95.0|16.4|281.9|||t-test, 2 sided|||||281.9|16.4|0.03
91711991|NCT03193047|183315401|SUPERIORITY||Median treatment difference|-28.512|STANDARD_ERROR_OF_MEAN|12.124||0.029|TWO_SIDED|95.0|-51.455|-3.93|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 2||-3.930|-51.455|0.029
91711992|NCT00996034|183315453|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||This is a comparison of scan 1 and scan 2||||<0.05
91616004|NCT01763905|183125305|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|30.9|53.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||53.4|30.9|<0.001
91616005|NCT01763905|183125305|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|42.0|||<|0.001|TWO_SIDED|95.0|30.3|51.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||51.8|30.3|<0.001
91616006|NCT01763905|183125306|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|48.0|||<|0.001|TWO_SIDED|95.0|35.0|57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||57.8|35.0|<0.001
91616007|NCT01763905|183125306|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|37.5|||<|0.001|TWO_SIDED|95.0|25.5|47.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||47.5|25.5|<0.001
91616008|NCT01763905|183125307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.53|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-36.34|-26.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.73|-36.34|<0.001
91616009|NCT01763905|183125307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.58|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-38.63|-30.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.54|-38.63|<0.001
91616010|NCT01763905|183125308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.09|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-37.28|-26.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.90|-37.28|<0.001
91616011|NCT01763905|183125308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.99|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-37.19|-28.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.79|-37.19|<0.001
91616012|NCT01763905|183125309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.2|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-36.92|-27.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.49|-36.92|<0.001
91616013|NCT01763905|183125309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-39.59|-30.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.39|-39.59|<0.001
91616014|NCT01763905|183125310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.86|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-38.04|-27.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.68|-38.04|<0.001
91656841|NCT02096718|183207147|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.23|STANDARD_DEVIATION|28.3|||TWO_SIDED|90.0|95.743|156.045|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||156.045|95.743|
91616015|NCT01763905|183125310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.1|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-38.04|-28.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.17|-38.04|<0.001
91616016|NCT01763905|183125311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.39|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-32.11|-22.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-22.67|-32.11|<0.001
91616017|NCT01763905|183125311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.94|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-34.72|-25.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-25.17|-34.72|<0.001
91711993|NCT02500719|183315482|SUPERIORITY||Mean Difference (Net)|0.1319||||0.029|ONE_SIDED||||||t-test, 1 sided|||This test is to determine if the difference between engagement and disengagement of emotional arousal is increased by real-time neurofeedback guidance in PTSD participants.||||.029
91711994|NCT00792116|183315490|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
91616018|NCT01763905|183125312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.28|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-31.42|-21.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-21.15|-31.42|<0.001
91616019|NCT01763905|183125312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.66|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-33.88|-23.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.43|-33.88|<0.001
91616020|NCT01763905|183125313|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.86|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-39.84|-29.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.88|-39.84|<0.001
91616021|NCT01763905|183125313|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.37|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-41.73|-31.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-31.01|-41.73|<0.001
91616022|NCT01763905|183125314|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-40.05|-29.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.00|-40.05|<0.001
91616023|NCT01763905|183125314|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|-39.87|-28.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.39|-39.87|<0.001
91616024|NCT01763905|183125315|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.9|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-31.27|-16.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.54|-31.27|<0.001
91616025|NCT01763905|183125315|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.26|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-33.75|-16.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.77|-33.75|<0.001
91616026|NCT01763905|183125316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.29|STANDARD_ERROR_OF_MEAN|4.03|<|0.001|TWO_SIDED|95.0|-33.26|-17.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-17.33|-33.26|<0.001
91616027|NCT01763905|183125316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.88|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-39.21|-16.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.56|-39.21|<0.001
91616028|NCT01763905|183125317|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.59|STANDARD_ERROR_OF_MEAN|4.45||0.97|TWO_SIDED|95.0|-11.38|6.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.20|-11.38|0.97
91616029|NCT01763905|183125317|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-6.42|STANDARD_ERROR_OF_MEAN|5.13||0.33|TWO_SIDED|95.0|-16.55|3.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||3.71|-16.55|0.33
91616030|NCT01763905|183125318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|1.58|STANDARD_ERROR_OF_MEAN|4.92||0.97|TWO_SIDED|95.0|-8.14|11.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.31|-8.14|0.97
91616031|NCT01763905|183125318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-4.69|STANDARD_ERROR_OF_MEAN|6.25||0.33|TWO_SIDED|95.0|-17.04|7.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||7.67|-17.04|0.33
91616032|NCT01763905|183125319|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.15|STANDARD_ERROR_OF_MEAN|2.23||0.068|TWO_SIDED|95.0|0.74|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.56|0.74|0.068
91711995|NCT00792116|183315491|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
91711996|NCT04776928|183315492|SUPERIORITY|||||||0.01|||||||Two-part regression model|||||||0.010
91791349|NCT03720652|183460430|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.66|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.66
91527446|NCT04091360|182930116|OTHER||GeoMean Ratio|1.129||||0.0098|TWO_SIDED|95.0|1.032|1.235|||ANCOVA|||||1.235|1.032|0.0098
91616033|NCT01763905|183125319|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.74|STANDARD_ERROR_OF_MEAN|2.28||0.13|TWO_SIDED|95.0|1.23|10.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||10.24|1.23|0.13
91616034|NCT01763905|183125320|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.57|STANDARD_ERROR_OF_MEAN|2.56||0.068|TWO_SIDED|95.0|-1.49|8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.63|-1.49|0.068
91616035|NCT01763905|183125320|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.83|STANDARD_ERROR_OF_MEAN|2.52||0.13|TWO_SIDED|95.0|-0.16|9.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.81|-0.16|0.13
91616036|NCT01763905|183125321|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|4.35||0.97|TWO_SIDED|95.0|-10.43|6.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.75|-10.43|0.97
91656842|NCT02096718|183207147|SUPERIORITY_OR_OTHER||Ratio of gmeans|149.97|STANDARD_DEVIATION|41.9|||TWO_SIDED|90.0|105.266|213.671|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.671|105.266|
91656843|NCT02096718|183207148|SUPERIORITY_OR_OTHER||Ratio of gmeans|101.16|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|72.931|140.309|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||140.309|72.931|
91656844|NCT02096718|183207148|SUPERIORITY_OR_OTHER||Ratio of gmeans|121.71|STANDARD_DEVIATION|34.2|||TWO_SIDED|90.0|90.79|163.162|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||163.162|90.790|
91656845|NCT02096718|183207149|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.44|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|96.141|155.928|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||155.928|96.141|
91656846|NCT02096718|183207149|SUPERIORITY_OR_OTHER||Ratio of gmeans|150.08|STANDARD_DEVIATION|41.5|||TWO_SIDED|90.0|105.626|213.25|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.250|105.626|
91656847|NCT03682900|183207150|SUPERIORITY||||||=|0||||||A one tailed test was used, as the intervention is expected to be superior than the control group. The criterion for significance was p \<. 05.|Mixed Models Analysis|There were no adjustments made for multiple comparisons.||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||= .000
91656848|NCT03682900|183207151|SUPERIORITY||||||=|0||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition||||= .000
91656849|NCT03682900|183207152|SUPERIORITY||||||=|0.044||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.044
91656850|NCT03682900|183207153|SUPERIORITY||||||=|0.033||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for significance is p\<.05.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.033
91656851|NCT03682900|183207154|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656852|NCT03682900|183207155|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656853|NCT03682900|183207156|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656854|NCT03682900|183207157|SUPERIORITY||||||<|0.001||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656855|NCT03682900|183207158|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656856|NCT03682900|183207159|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656857|NCT03682900|183207160|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91711997|NCT00103285|183315495|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.17|||||TWO_SIDED|95.0|1.61|16.63|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points.|Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||16.63|1.61|
91656858|NCT03682900|183207161|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91711998|NCT00103285|183315495|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|1.21|3.27|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.27|1.21|
91656859|NCT03682900|183207162|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a gneral linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656860|NCT03682900|183207163|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlayzed using a general linear mixed model with students nested within schools and schools within condition.||||<.001
91656861|NCT03682900|183207164|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. Apriori, a p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed uisng a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656862|NCT03682900|183207165|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is a priori considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear model with students nested within schools and schools nested within condition.||||<.001
91527447|NCT04091360|182930116|OTHER||GeoMean Ratio|1.028||||0.54|TWO_SIDED|95.0|0.939|1.125|||ANCOVA|||||1.125|0.939|0.54
91527448|NCT04091360|182930117|OTHER||GeoMean Ratio|1.228|||<|0.0001|TWO_SIDED|95.0|1.142|1.319|||ANCOVA|||||1.319|1.142|<0.0001
91527449|NCT04091360|182930117|OTHER||GeoMean Ratio|1.155||||0.0002|TWO_SIDED|95.0|1.075|1.24|||ANCOVA|||||1.240|1.075|0.0002
91791350|NCT03720652|183460430|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.84|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.84
91527450|NCT04091360|182930117|OTHER||GeoMean Ratio|1.1||||0.0129|TWO_SIDED|95.0|1.022|1.184|||ANCOVA|||||1.184|1.022|0.0129
91527451|NCT04091360|182930117|OTHER||GeoMean Ratio|1.112||||0.0079|TWO_SIDED|95.0|1.03|1.201|||ANCOVA|||||1.201|1.030|0.0079
91616037|NCT01763905|183125321|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.53|STANDARD_ERROR_OF_MEAN|4.85||0.33|TWO_SIDED|95.0|-13.12|6.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.06|-13.12|0.33
91616038|NCT01763905|183125322|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|4.7||0.97|TWO_SIDED|95.0|-9.96|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.61|-9.96|0.97
91616039|NCT01763905|183125322|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|5.72||0.33|TWO_SIDED|95.0|-11.24|11.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.39|-11.24|0.33
91616040|NCT01763905|183125323|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.9|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-42.26|-31.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-31.55|-42.26|<0.001
91616041|NCT01763905|183125323|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.69|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-43.06|-34.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-34.22|-43.06|<0.001
91616042|NCT04149899|183125324|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-4.9|STANDARD_DEVIATION|1.85|<|0.001|TWO_SIDED|95.0|-5.73|-4.14||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.14|-5.73|<0.001
91616043|NCT04149899|183125324|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-5.1|STANDARD_DEVIATION|2.51|<|0.001|TWO_SIDED|95.0|-6.14|-4.02||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.02|-6.14|<0.001
91616044|NCT04149899|183125324|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-6.0|STANDARD_DEVIATION|3.05|<|0.001|TWO_SIDED|95.0|-7.93|-4.07||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.07|-7.93|<0.001
91616045|NCT04149899|183125324|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.15% and Timolol 0.5%.||1.43|-1.16|0.828
91656863|NCT03682900|183207166|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656864|NCT03682900|183207167|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91656865|NCT03682900|183207168|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear model mixed model with students nested within schools and schools nested within condition.||||<.001
91656866|NCT03682900|183207169|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91527452|NCT04091360|182930117|OTHER||GeoMean Ratio|1.033||||0.39|TWO_SIDED|95.0|0.957|1.116|||ANCOVA|||||1.116|0.957|0.39
91711999|NCT00103285|183315495|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.03|3.34|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.34|1.03|
91712000|NCT00103285|183315496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.542|||||TWO_SIDED|95.0|1.974|3.273|||Regression, Cox|||4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (\<0.1%) or positive (\>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.||3.273|1.974|
91712001|NCT00103285|183315498|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.131|||||TWO_SIDED|95.0|0.101|0.17|||Chi-squared|||MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.||0.17|0.101|
91712002|NCT00103285|183315499|OTHER||Odds Ratio (OR)|4.1|||||TWO_SIDED|95.0|1.31|12.73|||Regression, Logistic|||Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.||12.73|1.31|
91712003|NCT03654729|183315585|SUPERIORITY||Risk Ratio (RR)|1.3842||||0.2266|TWO_SIDED|95.0|0.8172|2.3446|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||2.3446|0.8172|0.2266
91616046|NCT04149899|183125324|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.4% and Timolol 0.5%.||0.89|-1.73|0.520
91656867|NCT03682900|183207170|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schols and schools nested within condition.||||<.001
91712004|NCT03654729|183315585|SUPERIORITY||Risk Ratio (RR)|1.0951||||0.7434|TWO_SIDED|95.0|0.6356|1.887|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||1.8870|0.6356|0.7434
91712005|NCT03569098|183315638|SUPERIORITY||Difference in LS mean|0.32|STANDARD_ERROR_OF_MEAN|0.441||0.7669|TWO_SIDED|95.0|-0.55|1.19||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|Mixed Model for Repeated Measures (MMRM)|||Dysport 300 U versus Placebo.||1.19|-0.55|0.7669
91712006|NCT03569098|183315638|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.444||0.2085|TWO_SIDED|95.0|-1.24|0.51||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|MMRM|||Dysport 500 U versus Placebo.||0.51|-1.24|0.2085
91524276|NCT04022889|182923717|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|29.8|STANDARD_DEVIATION|18.5|||TWO_SIDED|95.0|21.8|37.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||37.8|21.8|
91527453|NCT04091360|182930118|OTHER||GeoMean Ratio|1.137|||<|0.0001|TWO_SIDED|95.0|1.073|1.204|||ANCOVA|||||1.204|1.073|<0.0001
91656868|NCT03682900|183207171|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
91712007|NCT04194489|183315672|OTHER|Effect size calculation|Cohen's d|0.43|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
91712008|NCT04194489|183315673|OTHER|Effect size|Cohen's d|0.17|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
91712009|NCT04194489|183315674|OTHER|Effect size calculation|Cohen's d|0.27|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
91712010|NCT04194489|183315675|OTHER|Effect size calculation|Cohen's d|0.02|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
91712011|NCT02485483|183315678|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.67|||<|0.001|TWO_SIDED|95.0|0.59|0.74||"Convergent Validity Criterion Correlation coefficient (ρ) \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 221||0.74|0.59|<0.001
91712012|NCT02485483|183315678|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.69|||<|0.001|TWO_SIDED|95.0|0.62|0.76||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 222||0.76|0.62|<0.001
91712013|NCT02485483|183315679|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.58||||0.057|TWO_SIDED|95.0|0.48|0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 203||0.66|0.48|0.057
91712014|NCT02485483|183315679|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.8||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 200||0.80|0.67|<0.001
91712015|NCT02485483|183315680|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.79||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 258||0.79|0.67|<0.001
91712016|NCT02485483|183315681|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.77||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 214||0.77|0.64|<0.001
91712017|NCT02485483|183315682|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.59||||0.034|TWO_SIDED|95.0|-0.67|-0.49||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 222||-0.49|-0.67|0.034
91712018|NCT02485483|183315682|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.61||||0.01|TWO_SIDED|95.0|-0.68|-0.52||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 223||-0.52|-0.68|0.010
91712019|NCT02485483|183315682|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.73|||<|0.001|TWO_SIDED|95.0|-0.78|-0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 222||-0.66|-0.78|<0.001
91712020|NCT02485483|183315683|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.54||||0.219|TWO_SIDED|95.0|-0.63|-0.43||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 202||-0.43|-0.63|0.219
91712021|NCT02485483|183315683|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.68|||<|0.001|TWO_SIDED|95.0|-0.75|-0.6||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 199||-0.60|-0.75|<0.001
91712022|NCT02485483|183315683|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.77|||<|0.001|TWO_SIDED|95.0|-0.82|-0.7||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 205||-0.70|-0.82|<0.001
91712023|NCT00377637|183315689|SUPERIORITY_OR_OTHER|||||||0.478||95.0|||||Regression, Logistic|Covariates included Treatment, Race, Geographical Region, and WHO Lupus Nephritis Class V and specified interaction terms.||||||0.478
91712024|NCT00377637|183315690|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Testing at the alpha=0.05 level was applied with no adjustments made for multiplicity.|Log Rank|||The difference in Kaplan-Meier survival curves between treatment groups (MMF-AZA) was assessed using a log-rank test, which is a non-parametric test to compare the survival distributions of two groups commonly used to analyze time-to-event endpoints.||||0.003
91712025|NCT00522548|183315703|SUPERIORITY|||||||0.29||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.29
91712026|NCT00522548|183315704|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.39
91712027|NCT00522548|183315705|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.0
91712028|NCT00522548|183315706|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.00
91712029|NCT00522548|183315707|SUPERIORITY|||||||0.14||||||a p value of less than 0.05 was considered statistically significant|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.14
91712030|NCT00522548|183315708|SUPERIORITY|||||||0.34||||||A p value of less than 0.05 was considered statistically significant.|Chi-squared|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.34
91524277|NCT04858802|182923763|SUPERIORITY||Mean Difference (Net)|4.19|STANDARD_DEVIATION|19.08||0.059|TWO_SIDED|95.0|-0.2|8.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.||8.6|-0.2|0.059
91712031|NCT00522548|183315709|SUPERIORITY_OR_OTHER|||||||0.51||||||A p-value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.51
91712032|NCT00522548|183315710|SUPERIORITY|||||||0.95|TWO_SIDED|95.0||||A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.95
91527454|NCT04091360|182930118|OTHER||GeoMean Ratio|1.091||||0.0041|TWO_SIDED|95.0|1.03|1.155|||ANCOVA|||||1.155|1.030|0.0041
91712033|NCT00522548|183315711|SUPERIORITY|||||||0.57||||||The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.57
91712034|NCT00522548|183315712|SUPERIORITY|||||||0.45|TWO_SIDED|95.0||||This represents p value for week 4 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.45
91712035|NCT00522548|183315712|SUPERIORITY|||||||0.58|TWO_SIDED|95.0||||This represents p value for week 24 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.58
91616047|NCT04149899|183125325|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||1.43|-1.16|0.828
91616048|NCT04149899|183125325|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.89|-1.73|0.520
91616049|NCT04149899|183125325|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.84||||0.283|TWO_SIDED|95.0|-2.39|0.71||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.71|-2.39|0.283
91616050|NCT04149899|183125325|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-1.02||||0.189|TWO_SIDED|95.0|-2.56|0.52||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.52|-2.56|0.189
91616051|NCT03456713|183125376|OTHER||Ratio of geometric least squares mean|1.47|||||TWO_SIDED|90.0|1.12|1.94||||||||1.94|1.12|
91616052|NCT03456713|183125377|OTHER||Ratio of geometric least squares mean|1.44|||||TWO_SIDED|90.0|1.15|1.81||||||||1.81|1.15|
91616053|NCT03456713|183125378|OTHER||Ratio of geometric least squares mean|1.66|||||TWO_SIDED|90.0|1.31|2.11||||||||2.11|1.31|
91616054|NCT03456713|183125379|SUPERIORITY||Ratio of Geometric Least Squares Means|0.73|||||TWO_SIDED|90.0|0.43|1.23||||||||1.23|0.43|
91616055|NCT03456713|183125380|OTHER||Ratio of geometric least squares mean|0.98|||||TWO_SIDED|90.0|0.58|1.67||||||||1.67|0.58|
91616056|NCT03456713|183125381|OTHER||Ratio of geometric least squares mean|0.7|||||TWO_SIDED|90.0|0.41|1.2||||||||1.20|0.41|
91712036|NCT00522548|183315713|SUPERIORITY|||||||0.012||||||This p value is for data at week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.012
91616057|NCT00681538|183125437|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.84||||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||||-0.40|-1.29|0.0002
91616058|NCT00681538|183125438|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.731||||0.0003|TWO_SIDED|95.0|1.589|4.694|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|30% responders||4.694|1.589|0.0003
91616059|NCT00681538|183125438|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.647||||0.0612|TWO_SIDED|95.0|0.977|2.777|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|50% Responders||2.777|0.977|0.0612
91616060|NCT00681538|183125439|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-2.53||||0.0046|TWO_SIDED|95.0|-4.27|-0.79|||ANCOVA||A negative difference indicates an improvement in spasm frequency in favour of Sativex.|||-0.79|-4.27|0.0046
91616061|NCT00681538|183125440|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA||A negative difference indicates an improvement in sleep disruption in favour of Sativex.|||-0.51|-1.25|<0.0001
91616062|NCT00681538|183125441|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-1.75||||0.0939|TWO_SIDED|95.0|-3.8|0.3|||ANCOVA||A negative difference indicates an improvement in spasticity in favour of Sativex.|||0.30|-3.80|0.0939
91616063|NCT00681538|183125442|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-2.85||||0.56|TWO_SIDED|95.0|-12.75|7.04|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For Arm||7.04|-12.75|0.56
91616064|NCT00681538|183125442|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.04||||0.98|TWO_SIDED|95.0|-2.56|2.64|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For leg||2.64|-2.56|0.98
91616065|NCT00681538|183125443|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-3.34||||0.0687|TWO_SIDED|95.0|-6.95|0.26|||ANCOVA||A negative treatment difference indicates an improvement in favour of Sativex.|||0.26|-6.95|0.0687
91616066|NCT00681538|183125444|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.703||||0.0234|TWO_SIDED|95.0|1.075|2.698|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||2.698|1.075|0.0234
91616067|NCT00681538|183125445|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4||||0.0053|TWO_SIDED|95.0|1.297|4.443|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||4.443|1.297|0.0053
91616068|NCT00681538|183125446|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.792||||0.0613|TWO_SIDED|95.0|0.973|3.301|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.301|0.973|0.0613
91712037|NCT00522548|183315713|SUPERIORITY|||||||0.046|TWO_SIDED|95.0||||This p value was for data at week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.||||0.046
91712038|NCT00522548|183315714|SUPERIORITY|||||||0.27||||||p value represents data for week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.27
91616069|NCT00681538|183125447|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.958||||0.0045|TWO_SIDED|95.0|1.232|3.112|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.112|1.232|0.0045
91616070|NCT00681538|183125448|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.02||||0.2836|TWO_SIDED|95.0|-0.02|0.07|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|For Health State Index||0.07|-0.02|0.2836
91616071|NCT00681538|183125448|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.24||||0.5644|TWO_SIDED|95.0|-3.01|5.5|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|Health Status VAS||5.50|-3.01|0.5644
91616072|NCT00681538|183125449|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.06||||0.9369|TWO_SIDED|95.0|-1.62|1.49|||ANCOVA||A negative difference indicates an improvement in depression in favour of Sativex.|||1.49|-1.62|0.9369
91616073|NCT00630812|183125450|SUPERIORITY||Mean Difference (Net)|54.14||||0.059|TWO_SIDED|95.0|-1.97|110.26|||Mixed Models Analysis|||||110.26|-1.97|0.059
91616074|NCT00630812|183125450|SUPERIORITY||Odds Ratio (OR)|1.69||||0.041|TWO_SIDED|95.0|1.02|2.8||Response defined as change of \>=100mL at week 26|Regression, Logistic|45.7% response on Mannitol 400mg, 35.5% on Control||||2.80|1.02|0.041
91616075|NCT00630812|183125451|SUPERIORITY||Mean Difference (Net)|43.49||||0.177|TWO_SIDED|95.0|-19.8|106.78|||Mixed Models Analysis|||||106.78|-19.8|0.177
91656869|NCT06354270|183207172|SUPERIORITY||Adjusted Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-1.29|-0.85|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.85|-1.29|<0.0001
91656870|NCT06354270|183207173|SUPERIORITY||Adjusted Mean Difference|36.72|STANDARD_ERROR_OF_MEAN|3.319|<|0.0001|TWO_SIDED|95.0|30.14|43.29|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||43.29|30.14|<0.0001
91524278|NCT04858802|182923764|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|12.98||0.328|TWO_SIDED|95.0|-1.5|4.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||4.5|-1.5|0.328
91616076|NCT00630812|183125452|SUPERIORITY||Rate ratio|0.85||||0.52|TWO_SIDED|95.0|0.51|1.41|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.41|0.51|0.520
91616077|NCT00630812|183125453|SUPERIORITY||Rate ratio|0.75||||0.328|TWO_SIDED|95.0|0.42|1.33|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.33|0.42|0.328
91616078|NCT00630812|183125454|SUPERIORITY||Rate ratio|0.89||||0.368|TWO_SIDED|95.0|0.69|1.15|||Poisson regression|||||1.15|0.69|0.368
91616079|NCT00630812|183125455|SUPERIORITY||Mean Difference (Net)|2.42||||0.024|TWO_SIDED|95.0|0.33|4.51|||ANCOVA|||||4.51|0.33|0.024
91616080|NCT00630812|183125456|SUPERIORITY||Mean Difference (Net)|71.35||||0.022|TWO_SIDED|95.0|10.57|132.13|||Mixed Models Analysis|||||132.13|10.57|0.022
91616081|NCT00630812|183125457|SUPERIORITY||Mean Difference (Net)|34.34||||0.49|TWO_SIDED|95.0|-63.47|132.14|||Mixed Models Analysis|||||132.14|-63.47|0.49
91616082|NCT00630812|183125458|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
91616083|NCT00069095|183125465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|97.5|0.94|1.18||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.18|0.94|
91616084|NCT00069095|183125466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.22|||||TWO_SIDED|97.5|1.05|1.42||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.42|1.05|
91616085|NCT00069095|183125467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|97.5|0.58|0.83|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.83|0.58|<0.0001
91616086|NCT00069095|183125468|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in the 'on-treatment analysis', thus leading to reduced power. No formal statistical testing was therefore applied.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|97.5|1.07|1.44||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.44|1.07|
91656871|NCT06354270|183207174|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.46|-0.79|<0.0001
91527455|NCT04091360|182930118|OTHER||GeoMean Ratio|1.019||||0.53|TWO_SIDED|95.0|0.96|1.081|||ANCOVA|||||1.081|0.960|0.53
91712039|NCT00522548|183315714|SUPERIORITY|||||||0.23|TWO_SIDED|95.0||||p value represents data for week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.23
91712040|NCT02820870|183315735|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.01|TWO_SIDED|95.0|1.84|4.9|||Regression, Logistic|With clustering by provider and team.||||4.9|1.84|<0.01
91616087|NCT00069095|183125469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|97.5|0.52|0.75|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.75|0.52|<0.0001
91616088|NCT00069095|183125470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|97.5|0.92|1.15||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.15|0.92|
91616089|NCT00069095|183125471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0015|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0015
91616090|NCT00069095|183125472|NON_INFERIORITY_OR_EQUIVALENCE|This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|97.5|0.84|1.14||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.14|0.84|
91616091|NCT00069095|183125473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1921|TWO_SIDED|97.5|0.72|1.09|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented together with the 97.5% confidence interval.||1.09|0.72|0.1921
91616092|NCT00069095|183125474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0023|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0023
91616093|NCT00069095|183125475|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.89|||||TWO_SIDED|97.5|0.72|1.09||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66, where OR denotes Odds ratio.||1.09|0.72|
91616094|NCT00069095|183125476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.3091|TWO_SIDED|97.5|0.71|1.14|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%.||1.14|0.71|0.3091
91616095|NCT00069095|183125477|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.94|||||TWO_SIDED|97.5|0.76|1.16||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66||1.16|0.76|
91656872|NCT06354270|183207175|SUPERIORITY||Adjusted Mean Difference|14.31|STANDARD_ERROR_OF_MEAN|2.128|<|0.0001|TWO_SIDED|95.0|10.09|18.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||18.52|10.09|<0.0001
91656873|NCT06354270|183207176|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.252||0.196|TWO_SIDED|95.0|-0.83|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.17|-0.83|0.1960
91527456|NCT04091360|182930126|OTHER||GeoMean Ratio|1.21|||<|0.0001|TWO_SIDED|95.0|1.153|1.27|||ANCOVA|||||1.270|1.153|<0.0001
91616096|NCT00069095|183125478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9887|TWO_SIDED|97.5|0.78|1.28|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%||1.28|0.78|0.9887
91616097|NCT00069095|183125479|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|97.5|0.97|1.2||||||General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.20|0.97|
91656874|NCT06354270|183207176|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.344||0.2287|TWO_SIDED|95.0|-1.08|0.28|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.28|-1.08|0.2287
91527457|NCT04091360|182930126|OTHER||GeoMean Ratio|1.193|||<|0.0001|TWO_SIDED|95.0|1.136|1.252|||ANCOVA|||||1.252|1.136|<0.0001
91616098|NCT00069095|183125479|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|97.5|0.98|1.23||||||On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.23|0.98|
91616099|NCT00069095|183125480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.003|TWO_SIDED|97.5|0.74|0.96|||Log Rank|||General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.96|0.74|0.0030
91616100|NCT00069095|183125480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0004|TWO_SIDED|97.5|0.7|0.92|||Log Rank|||On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.92|0.70|0.0004
91616101|NCT00069095|183125483|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was performed for duration of overall response.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|97.5|0.86|1.22||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.22|0.86|
91616102|NCT00069095|183125484|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0307|TWO_SIDED|97.5|0.66|1.01|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||1.01|0.66|0.0307
91616103|NCT00069095|183125485|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|97.5|0.09|1.39||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.39|0.09|
91616104|NCT00069095|183125486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.8207|TWO_SIDED|97.5|0.2|7.05|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||7.05|0.20|0.8207
91616105|NCT05761444|183125487|OTHER||Least Squares (LS) mean difference|-21.22|||<|0.0001|TWO_SIDED|95.0|-29.26|-13.19||The analysis of covariance (ANCOVA) model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-13.19|-29.26|<0.0001
91616106|NCT05761444|183125490|OTHER||LS mean difference|-15.96|||<|0.0001|TWO_SIDED|95.0|-23.56|-8.36||The ANCOVA model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-8.36|-23.56|<0.0001
91656875|NCT06354270|183207176|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.235|TWO_SIDED|95.0|-0.89|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.22|-0.89|0.2350
91656876|NCT06354270|183207176|SUPERIORITY||Adjusted Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.328||0.1818|TWO_SIDED|95.0|-1.09|0.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.21|-1.09|0.1818
91656877|NCT06354270|183207176|SUPERIORITY||Adjusted Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.357||0.1316|TWO_SIDED|95.0|-1.25|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.17|-1.25|0.1316
91616107|NCT02868216|183125521|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|0.84||0.05|TWO_SIDED|95.0|0.63|3.98|||ANOVA|||||3.98|0.63|0.05
91616108|NCT03161678|183125522|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.|||||<|0.001|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||<0.001
91616109|NCT03161678|183125522|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.24|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.24
91656878|NCT06354270|183207176|SUPERIORITY||Adjusted Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.417||0.0658|TWO_SIDED|95.0|-1.6|0.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||0.05|-1.60|0.0658
91656879|NCT06354270|183207177|SUPERIORITY||Adjusted Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|4.862||0.8072|TWO_SIDED|95.0|-8.45|10.83|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||10.83|-8.45|0.8072
91616110|NCT03161678|183125523|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.75|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.75
91712041|NCT02820870|183315736|SUPERIORITY||Odds Ratio (OR)|1.65||||0.06|TWO_SIDED|95.0|0.99|2.77|||Regression, Logistic|With cluster by provider and team.||||2.77|0.99|0.06
91712042|NCT00313846|183315761|SUPERIORITY_OR_OTHER|||||||0.0026|||||||Kaplan-Meier estimate mean|||||||.0026
91712043|NCT03428100|183315773|SUPERIORITY||Odds Ratio (OR)|1.78||||0.071|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.071
91712044|NCT03428100|183315773|SUPERIORITY||Odds Ratio (OR)|2.15||||0.031|TWO_SIDED|95.0|1.07|4.3|||Regression, Logistic|||||4.30|1.07|0.031
91712045|NCT03428100|183315774|SUPERIORITY||Odds Ratio (OR)|1.34||||0.427|TWO_SIDED|95.0|0.65|2.77|||Regression, Logistic|||||2.77|0.65|0.427
91712046|NCT03428100|183315775|SUPERIORITY||Odds Ratio (OR)|1.35||||0.513|TWO_SIDED|95.0|0.55|3.35|||Regression, Logistic|||||3.35|0.55|0.513
91712047|NCT03428100|183315775|SUPERIORITY||Odds Ratio (OR)|1.6||||0.242|TWO_SIDED|95.0|0.73|3.53|||Regression, Logistic|||||3.53|0.73|0.242
91712048|NCT03428100|183315775|SUPERIORITY||Odds Ratio (OR)|2.54||||0.03|TWO_SIDED|95.0|1.09|5.9|||Regression, Logistic|||||5.90|1.09|0.030
91712049|NCT03428100|183315776|SUPERIORITY||Odds Ratio (OR)|1.32||||0.611|TWO_SIDED|95.0|0.45|3.83|||Regression, Logistic|||||3.83|0.45|0.611
91712050|NCT03428100|183315776|SUPERIORITY||Odds Ratio (OR)|1.59||||0.325|TWO_SIDED|95.0|0.63|3.99|||Regression, Logistic|||||3.99|0.63|0.325
91616111|NCT03161678|183125523|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.011|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.011
91712051|NCT03428100|183315776|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1|TWO_SIDED|95.0|0.85|6.14|||Regression, Logistic|||||6.14|0.85|0.100
91712052|NCT03428100|183315777|SUPERIORITY||Mean Difference (Final Values)|-17.65|STANDARD_ERROR_OF_MEAN|5.627||0.002|TWO_SIDED|95.0|-28.71|-6.58|||Mixed Models Analysis|||||-6.58|-28.71|0.002
91712053|NCT03428100|183315777|SUPERIORITY||Mean Difference (Final Values)|-13.35|STANDARD_ERROR_OF_MEAN|4.82||0.006|TWO_SIDED|95.0|-22.83|-3.87|||Mixed Models Analysis|||||-3.87|-22.83|0.006
91712054|NCT03428100|183315777|SUPERIORITY||Mean Difference (Final Values)|-20.62|STANDARD_ERROR_OF_MEAN|5.554||0.0002|TWO_SIDED|95.0|-31.54|-9.7|||Mixed Models Analysis|||||-9.70|-31.54|0.0002
91712055|NCT03428100|183315778|SUPERIORITY||Odds Ratio (OR)|4.14||||0.115|TWO_SIDED|95.0|0.71|24.29|||Regression, Logistic|||||24.29|0.71|0.115
91712056|NCT03428100|183315778|SUPERIORITY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.88|||Regression, Logistic|||||30.88|1.11|0.037
91527458|NCT04091360|182930126|OTHER||GeoMean Ratio|1.124|||<|0.0001|TWO_SIDED|95.0|1.071|1.179|||ANCOVA|||||1.179|1.071|<0.0001
91527459|NCT04091360|182930127|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.087|1.194|||ANCOVA|||||1.194|1.087|<0.0001
91712057|NCT03428100|183315778|SUPERIORITY||Odds Ratio (OR)|4.78||||0.083|TWO_SIDED|95.0|0.81|28.08|||Regression, Logistic|||||28.08|0.81|0.083
91712058|NCT03428100|183315779|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.29|8.32|||Regression, Logistic|||||8.32|1.29|0.012
91712059|NCT03428100|183315779|SUPERIORITY||Odds Ratio (OR)|3.71||||0.002|TWO_SIDED|95.0|1.59|8.66|||Regression, Logistic|||||8.66|1.59|0.002
91712060|NCT03428100|183315779|SUPERIORITY||Odds Ratio (OR)|6.85||||2e-05|TWO_SIDED|95.0|2.79|16.82|||Regression, Logistic|||||16.82|2.79|0.00002
91712061|NCT03428100|183315780|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.203||0.039|TWO_SIDED|95.0|-0.82|-0.02|||Mixed Models Analysis|||||-0.02|-0.82|0.039
91712062|NCT03428100|183315780|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.175||0.23|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.23
91712063|NCT03428100|183315780|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.201||0.0001|TWO_SIDED|95.0|-1.18|-0.39|||Mixed Models Analysis|||||-0.39|-1.18|0.0001
91712064|NCT03428100|183315781|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.388||0.0714|TWO_SIDED|95.0|-1.47|0.06|||Mixed Models Analysis|||||0.06|-1.47|0.0714
91712065|NCT03428100|183315781|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.337||0.0134|TWO_SIDED|95.0|-1.5|-0.17|||Mixed Models Analysis|||||-0.17|-1.50|0.0134
91712066|NCT03428100|183315781|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.386||0.0002|TWO_SIDED|95.0|-2.21|-0.69|||Mixed Models Analysis|||||-0.69|-2.21|0.0002
91712067|NCT03428100|183315782|SUPERIORITY||Odds Ratio (OR)|1.71||||0.183|TWO_SIDED|95.0|0.78|3.75|||Regression, Logistic|||||3.75|0.78|0.183
91712068|NCT03428100|183315782|SUPERIORITY||Odds Ratio (OR)|1.54||||0.235|TWO_SIDED|95.0|0.76|3.11|||Regression, Logistic|||||3.11|0.76|0.235
91712069|NCT03428100|183315782|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.43|2.36|||Regression, Logistic|||||2.36|0.43|0.991
91712070|NCT03428100|183315783|SUPERIORITY||Odds Ratio (OR)|1.41||||0.263|TWO_SIDED|95.0|0.77|2.57|||Regression, Logistic|||||2.57|0.77|0.263
91712071|NCT03428100|183315783|SUPERIORITY||Odds Ratio (OR)|1.89||||0.016|TWO_SIDED|95.0|1.13|3.19|||Regression, Logistic|||||3.19|1.13|0.016
91712072|NCT03428100|183315783|SUPERIORITY||Odds Ratio (OR)|1.93||||0.031|TWO_SIDED|95.0|1.06|3.52|||Regression, Logistic|||||3.52|1.06|0.031
91712073|NCT03428100|183315784|SUPERIORITY||Odds Ratio (OR)|1.97||||0.058|TWO_SIDED|95.0|0.98|3.96|||Regression, Logistic|||||3.96|0.98|0.058
91791351|NCT03720652|183460431|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.015|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.015
91616112|NCT00752609|183125524|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.42|||||TWO_SIDED|95.0|-0.65|-0.19|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||-0.19|-0.65|
91616113|NCT00752609|183125524|SUPERIORITY_OR_OTHER||Mean change from baseline|0.49|||||TWO_SIDED|95.0|0.26|0.71|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.71|0.26|
91616114|NCT00904826|183125539|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between before treatment and one year after treatment.||||<0.0001
91616115|NCT00904826|183125541|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was made between baseline and after 12 months of treatment.||||0.0078
91616116|NCT00904826|183125545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 weeks and baseline.||||<0.0001
91616117|NCT00904826|183125545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 3 months and baseline.||||<0.0001
91616118|NCT00904826|183125545|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 months and baseline||||0.0001
91616119|NCT00904826|183125545|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 9 months and baseline.||||0.0001
91616120|NCT00904826|183125545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 12 months and baseline.||||<0.0001
91616121|NCT00904826|183125547|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was between 3 months and baseline.||||0.0019
91616122|NCT02026271|183125580|OTHER||||||||||||||||||"MTD was not determined in this study. Dose escalation decision rules were based on a standard 3+3 design modified to independently evaluate the two stratified subject groups that may exhibit different safety and tolerability profiles.~The study was planned to explore 4 veledimex (V) dose cohorts of 20, 40, 80 and 120 mg once daily, and two doses of Ad-RTS-hIL-12 (2x10\^11vp and 1x10\^12vp). Dose cohorts were treated at 10, 20, 30 and 40 mg of V. Only one dose of Ad-RTS-hIL-12 was explored (2x10\^11vp).~If ≥ 33% of subjects in the expansion cohort experience DLTs, additional subjects may be enrolled at the next lower dose, or at an intermediate dose, as recommended by the SRC.~Grp 1: After 20mg cohort, SRC approved 40mg, which was deemed the MAD due to DLTs. SRC approved 30mg cohort to determine MTD, but due to poor compliance, SRC opened a 20mg exp cohort and then an intermediate 10mg cohort. Based on V compliance and efficacy, 20mg was determined to be the optimal dose."|||
91616123|NCT00783705|183125659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.39|TWO_SIDED|95.0|0.7|3.0|||Generalized estimating equation model|||Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.||3.0|0.7|0.39
91616124|NCT00783705|183125663|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.10
91616125|NCT00783705|183125664|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.03
91616126|NCT00783705|183125665|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.58
91616127|NCT00783705|183125666|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.06
91656880|NCT06354270|183207177|SUPERIORITY||Adjusted Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|6.175||0.9641|TWO_SIDED|95.0|-11.96|12.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||12.52|-11.96|0.9641
91656881|NCT06354270|183207178|SUPERIORITY||Adjusted Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.75||0.2538|TWO_SIDED|95.0|-0.63|2.35|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.35|-0.63|0.2538
91656882|NCT06354270|183207178|SUPERIORITY||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.922||0.7311|TWO_SIDED|95.0|-2.15|1.51|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.51|-2.15|0.7311
91616128|NCT00783705|183125667|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.63
91616129|NCT00783705|183125668|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.22
91616130|NCT00783705|183125669|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Total Glutathione level between arms.||||0.06
91616131|NCT00783705|183125670|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.35
91616132|NCT00783705|183125671|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CRP level between arms.||||0.80
91616133|NCT00783705|183125672|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.22
91616134|NCT00783705|183125673|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.74
91616135|NCT00783705|183125674|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.55
91616136|NCT00783705|183125675|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Nitrotyrosine level between arms.||||0.91
91712074|NCT03428100|183315784|SUPERIORITY||Odds Ratio (OR)|1.77||||0.072|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.072
91791352|NCT03720652|183460431|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
91616137|NCT00783705|183125676|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.46
91616138|NCT00783705|183125677|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.52
91616139|NCT04743635|183125683|OTHER|"Performance goal.~Hypothesis:~Ho: D \< 1 Ha: D ≥ 1, where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance goal. If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 then we will reject the null hypothesis and conclude the device performs effectively."|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|0.9||0.0001|TWO_SIDED|95.0|1.28|1.71|||t-test, 2 sided|The 2-sided 95% confidence interval for the mean reduction in CSS was calculated along with the corresponding p-value (Student's t-test).||The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.||1.71|1.28|.0001
91616140|NCT04743635|183125684|OTHER|Performance goal. The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.|Percentage improved|95.6||||0.0001|TWO_SIDED|95.0|87.6|99.1|||t-test, 2 sided|||"The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if improved, worse and much worse, worse was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3)."||99.1|87.6|.0001
91616141|NCT04743635|183125687|OTHER|Performance goal. In order to meet the endpoint, the lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.|Percentage improved|72.1||||0.0264|TWO_SIDED|95.0|59.9|82.3|||t-test, 2 sided|||||82.3|59.9|.0264
91616142|NCT00804193|183125689|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).|Difference in Percentage of Participants|9.0|||||TWO_SIDED|90.0|-0.69|18.85|||Wald's method, Yates|CI calculated using Wald's method with Yates' continuity correction.|The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||18.85|-0.69|
91616143|NCT00804193|183125690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|1.0||||0.001|TWO_SIDED|90.0|-7.08|9.24|||Wald's method with Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||9.24|-7.08|0.001
91616144|NCT00804193|183125691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|4.0||||0.001|TWO_SIDED|90.0|-4.6|14.24|||Wald's method Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||14.24|-4.60|0.001
91616145|NCT04415489|183125692|SUPERIORITY|||||||0.57||||||The a priori threshold for statistical significance was p \< 0.05.|Fisher Exact|||||||0.57
91616146|NCT04415489|183125693|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was p \< 0.05.|t-test, 2 sided|||||||<0.01
91616147|NCT04415489|183125694|SUPERIORITY|||||||0.11||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.11
91616148|NCT04415489|183125695|SUPERIORITY|||||||0.16||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.16
91616149|NCT04415489|183125696|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||< 0.01
91616150|NCT04415489|183125700|SUPERIORITY|||||||0.12||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.12
91616151|NCT01193348|183125701|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|63.6|||||TWO_SIDED|95.0|40.7|82.8||||||||82.8|40.7|
91616152|NCT01193348|183125702|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|81.8|||||TWO_SIDED|95.0|59.7|94.8||||||||94.8|59.7|
91616153|NCT01193348|183125703|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.0|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
91616154|NCT01193348|183125704|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
91616155|NCT01193348|183125705|SUPERIORITY_OR_OTHER||LS mean change from baseline|204.96|||<|0.0001|TWO_SIDED|95.0|164.44|245.49|||ANOVA|||||245.49|164.44|<0.0001
91616156|NCT01193348|183125706|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|68.2|||||TWO_SIDED|95.0|45.1|86.1||||||||86.1|45.1|
91656883|NCT06354270|183207179|SUPERIORITY||Adjusted Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|2.162||0.7202|TWO_SIDED|95.0|-3.51|5.06|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||5.06|-3.51|0.7202
91527460|NCT04091360|182930127|OTHER||GeoMean Ratio|1.142|||<|0.0001|TWO_SIDED|95.0|1.089|1.197|||ANCOVA|||||1.197|1.089|<0.0001
91616157|NCT01193348|183125707|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|90.9|||||TWO_SIDED|95.0|70.8|98.9||||||||98.9|70.8|
91616158|NCT01193348|183125708|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.5|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
91616159|NCT01193348|183125709|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
91616160|NCT01193348|183125710|SUPERIORITY_OR_OTHER||LS mean change from baseline|165.43|||<|0.0001|TWO_SIDED|95.0|98.43|232.43|||ANOVA|||||232.43|98.43|<0.0001
91712075|NCT03428100|183315784|SUPERIORITY||Odds Ratio (OR)|1.56||||0.224|TWO_SIDED|95.0|0.76|3.18|||Regression, Logistic|||||3.18|0.76|0.224
91616161|NCT00968253|183125716|SUPERIORITY_OR_OTHER||Maximum tolerated dose|5.0|||||TWO_SIDED||||||||Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD|||||
91616162|NCT05299983|183125790|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
91616163|NCT05299983|183125791|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
91616164|NCT05299983|183125792|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
91616165|NCT05299983|183125793|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
91616166|NCT02614287|183125810|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91616167|NCT02614287|183125814|SUPERIORITY|||||||0.215|||||||Fisher Exact|||TE ADA Positive (TE ADA+)||||.215
91616168|NCT02614287|183125815|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.6|TWO_SIDED|95.0|-1.76|0.04|||Mixed Models Analysis|||||0.04|-1.76|0.60
91616169|NCT02614287|183125816|SUPERIORITY||LSMean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.835|TWO_SIDED|95.0|-0.72|0.89|||Mixed Models Analysis|||||0.89|-0.72|.835
91616170|NCT02614287|183125817|SUPERIORITY||Odds Ratio (OR)|1.467||||0.063|TWO_SIDED|95.0|0.979|2.197|||CPLRM|CPLRM: Categorical pseudo likelihood-based repeated measures model||||2.197|0.979|.063
91616171|NCT02614287|183125818|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.937|TWO_SIDED|95.0|-0.96|1.04|||Mixed Models Analysis|||||1.04|-0.96|.937
91616172|NCT02614287|183125819|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.073|TWO_SIDED|95.0|-0.4|0.02|||Mixed Models Analysis|||||0.02|-0.40|0.073
91616173|NCT02614287|183125820|SUPERIORITY||LSMean Difference|0.91|STANDARD_ERROR_OF_MEAN|2.82||0.747|TWO_SIDED|95.0|-4.65|6.47|||Mixed Models Analysis|||||6.47|-4.65|.747
91616174|NCT02614287|183125821|SUPERIORITY||LSMean Difference|1.98|STANDARD_ERROR_OF_MEAN|1.55||0.203|TWO_SIDED|95.0|-1.07|5.03|||Mixed Models Analysis|||Total Score||5.03|-1.07|0.203
91616175|NCT02614287|183125821|SUPERIORITY||LSMean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.59||0.247|TWO_SIDED|95.0|-1.29|4.98|||Mixed Models Analysis|||Role Function-Restrictive Domain Score||4.98|-1.29|.247
91616176|NCT02614287|183125821|SUPERIORITY||LSMean Difference|1.26|STANDARD_ERROR_OF_MEAN|1.49||0.399|TWO_SIDED|95.0|-1.67|4.19|||Mixed Models Analysis|||Role Function-Preventive Domain Score||4.19|-1.67|0.399
91616177|NCT02614287|183125821|SUPERIORITY||LSMean Difference|3.09|STANDARD_ERROR_OF_MEAN|1.8||0.88|TWO_SIDED|95.0|-0.46|6.64|||Mixed Models Analysis|||Emotional Function Domain Score||6.64|-0.46|0.88
91616178|NCT00418834|183125824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-16.0|-11.7|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-11.7|-16.0|<0.001
91616179|NCT00418834|183125825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.4|-1.8|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.8|-7.4|<0.001
91616180|NCT00418834|183125826|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.32|||<|0.001||95.0|4.52|8.84|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||8.84|4.52|<0.001
91656884|NCT06354270|183207179|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|2.532||0.9859|TWO_SIDED|95.0|-5.06|4.98|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||4.98|-5.06|0.9859
91656885|NCT06354270|183207180|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.78||0.5586|TWO_SIDED|95.0|-2.0|1.09|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||1.09|-2.00|0.5586
91527461|NCT04091360|182930127|OTHER||GeoMean Ratio|1.08||||0.0018|TWO_SIDED|95.0|1.031|1.132|||ANCOVA|||||1.132|1.031|0.0018
91616181|NCT00418834|183125827|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87|||<|0.001||95.0|1.4|2.5|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.50|1.40|<0.001
91616182|NCT00418834|183125828|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.48|||<|0.001||95.0|3.98|7.55|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||7.55|3.98|<0.001
91616183|NCT00418834|183125829|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||<|0.001||95.0|1.32|2.31|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.31|1.32|<0.001
91616184|NCT00418834|183125830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|0.3|3.5|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||3.5|0.3|<0.001
91616185|NCT00418834|183125831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.5|4.8|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.8|1.5|<0.001
91616186|NCT00418834|183125832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-14.2|-10.3|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.3|-14.2|<0.001
91616187|NCT00418834|183125833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-6.8|-1.7|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.7|-6.8|<0.001
91616188|NCT00418834|183125834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0|-9.4|-6.5|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-6.5|-9.4|<0.001
91616189|NCT00418834|183125835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-3.8|-0.2|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.2|-3.8|<0.001
91656886|NCT06354270|183207180|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.961||0.873|TWO_SIDED|95.0|-2.06|1.75|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.75|-2.06|0.8730
91616190|NCT00418834|183125836|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.2|||<|0.001||95.0|-9.0|-3.4|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||-3.4|-9.0|<0.001
91616191|NCT00418834|183125837|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.1|||<|0.001||95.0|-5.2|1.0|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates~of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||1.0|-5.2|<0.001
91616192|NCT00418834|183125838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-11.0|-7.3|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-11.0|<0.001
91616193|NCT00418834|183125839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-5.5|-0.9|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.9|-5.5|<0.001
91616194|NCT00418834|183125840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.8||0.401||95.0|-0.9|2.1|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||2.1|-0.9|0.401
91616195|NCT00418834|183125841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.1|4.2|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.2|1.1|<0.001
91616196|NCT00418834|183125842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-10.7|-7.3|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-10.7|<0.001
91616197|NCT00418834|183125843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-6.8|-2.4|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.4|-6.8|<0.001
91616198|NCT00418834|183125844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-17.0|-12.2|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-12.2|-17.0|<0.001
91712076|NCT03428100|183315785|SUPERIORITY||Odds Ratio (OR)|5.03||||0.265|TWO_SIDED|95.0|0.29|86.08|||Regression, Logistic|||||86.08|0.29|0.265
91616199|NCT00418834|183125845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.1|-3.7|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.7|-10.1|<0.001
91616200|NCT00418834|183125846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-11.6|-7.5|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.5|-11.6|<0.001
91616201|NCT00418834|183125847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.7|-2.9|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.9|-7.7|<0.001
91616202|NCT00418834|183125848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-15.3|-10.5|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.5|-15.3|<0.001
91656887|NCT06354270|183207181|SUPERIORITY||Adjusted Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|1.383||0.6191|TWO_SIDED|95.0|-3.43|2.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.05|-3.43|0.6191
91527462|NCT04091360|182930128|OTHER||GeoMean Ratio|1.08||||0.0066|TWO_SIDED|95.0|1.022|1.14|||ANCOVA|||||1.140|1.022|0.0066
91616203|NCT00418834|183125849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.8|-3.6|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.6|-9.8|<0.001
91616204|NCT00418834|183125850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8||||0.534||95.0|-11.9|6.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||6.4|-11.9|0.534
91616205|NCT00418834|183125851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.09||95.0|-15.6|1.6|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||1.6|-15.6|0.090
91616206|NCT01953328|183125852|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-73.97|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-78.54|-69.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.41|-78.54|<0.001
91656888|NCT06354270|183207181|SUPERIORITY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.669||0.9521|TWO_SIDED|95.0|-3.41|3.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||3.21|-3.41|0.9521
91656889|NCT06354270|183207182|SUPERIORITY||Adjusted Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.795||0.3887|TWO_SIDED|95.0|-0.89|2.26|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.26|-0.89|0.3887
91712077|NCT03428100|183315785|SUPERIORITY||Odds Ratio (OR)|2.54||||0.52|TWO_SIDED|95.0|0.15|43.09|||Regression, Logistic|||||43.09|0.15|0.520
91616207|NCT01953328|183125852|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.89|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-77.22|-68.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.57|-77.22|<0.001
91616208|NCT01953328|183125852|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.41|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-81.21|-67.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-67.61|-81.21|<0.001
91616209|NCT01953328|183125852|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.27|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-78.93|-69.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.60|-78.93|<0.001
91616210|NCT01953328|183125853|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.85|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-80.22|-69.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.47|-80.22|<0.001
91616211|NCT01953328|183125853|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.91|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-74.6|-65.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.23|-74.60|<0.001
91616212|NCT01953328|183125853|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-78.85|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-83.55|-68.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.15|-83.55|<0.001
91616213|NCT01953328|183125853|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.87|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-72.88|-60.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.87|-72.88|<0.001
91616214|NCT01953328|183125854|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-89.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-98.4|-80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.2|-98.4|<0.001
91616215|NCT01953328|183125854|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-86.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-95.1|-77.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-77.5|-95.1|<0.001
91616216|NCT01953328|183125854|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.7|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-75.3|-62.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.1|-75.3|<0.001
91616217|NCT01953328|183125854|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.0|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-79.5|-64.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.6|-79.5|<0.001
91712078|NCT03428100|183315785|SUPERIORITY||Odds Ratio (OR)|7.17||||0.164|TWO_SIDED|95.0|0.45|99.99|||Regression, Logistic|||||99.99|0.45|0.164
91712079|NCT03428100|183315786|SUPERIORITY||Mean Difference (Final Values)|-6.08|STANDARD_ERROR_OF_MEAN|2.948||0.04|TWO_SIDED|95.0|-11.88|-0.29|||Mixed Models Analysis|||||-0.29|-11.88|0.040
91712080|NCT03428100|183315786|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|2.533||0.01|TWO_SIDED|95.0|-11.54|-1.58|||Mixed Models Analysis|||||-1.58|-11.54|0.010
91656890|NCT06354270|183207182|SUPERIORITY||Adjusted Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.989||0.373|TWO_SIDED|95.0|-1.08|2.84|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||2.84|-1.08|0.3730
91656891|NCT06354270|183207183|SUPERIORITY||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.134||0.1591|TWO_SIDED|95.0|-0.08|0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.46|-0.08|0.1591
91656892|NCT06354270|183207183|SUPERIORITY||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.144||0.3429|TWO_SIDED|95.0|-0.15|0.42|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.42|-0.15|0.3429
91656893|NCT06354270|183207184|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.411||0.136|TWO_SIDED|95.0|-1.43|0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.20|-1.43|0.1360
91656894|NCT06354270|183207184|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.431||0.2914|TWO_SIDED|95.0|-1.31|0.4|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.40|-1.31|0.2914
91656895|NCT05097989|183207185|OTHER||Percentage Difference|-17.7||||0.2422|TWO_SIDED|90.0|-37.5|8.3|||ANCOVA|||||8.3|-37.5|0.2422
91656896|NCT05097989|183207185|OTHER||Percentage Difference|-6.0||||0.8701|TWO_SIDED|90.0|-49.3|74.4|||ANCOVA|||||74.4|-49.3|0.8701
91656897|NCT02809183|183207200|OTHER|Single-group test|Group LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5547|TWO_SIDED|95.0|-0.9|0.5||The null hypothesis is that the mean change from baseline within the Pooled Placebo treatment group = 0 mEq/L.|Mixed Models Analysis|||||0.5|-0.9|0.5547
91656898|NCT02809183|183207200|OTHER|Single-group test|Group LS mean|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.4|4.0||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID group = 0 mEq/L|Mixed Models Analysis|||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.||4.0|2.4|< 0.0001
91712081|NCT03428100|183315786|SUPERIORITY||Mean Difference (Final Values)|-9.77|STANDARD_ERROR_OF_MEAN|2.919|<|0.001|TWO_SIDED|95.0|-15.51|-4.03|||Mixed Models Analysis|||||-4.03|-15.51|<0.001
91712082|NCT03428100|183315787|SUPERIORITY||Odds Ratio (OR)|4.75||||0.265|TWO_SIDED|95.0|0.31|73.93|||Regression, Logistic|||||73.93|0.31|0.265
91712083|NCT03428100|183315787|SUPERIORITY||Odds Ratio (OR)|2.5||||0.511|TWO_SIDED|95.0|0.16|38.4|||Regression, Logistic|||||38.40|0.16|0.511
91616218|NCT01953328|183125855|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-90.8|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-100.9|-80.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.7|-100.9|<0.001
91616219|NCT01953328|183125855|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.5|-74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-74.8|-92.5|<0.001
91656899|NCT02809183|183207200|OTHER|Single-group test|Group LS mean|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.2|3.8||The null hypothesis is the 3g TRC101 BID treatment group mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||3.8|2.2|< 0.0001
91712084|NCT03428100|183315787|SUPERIORITY||Odds Ratio (OR)|4.95||||0.253|TWO_SIDED|95.0|0.32|77.11|||Regression, Logistic|||||77.11|0.32|0.253
91656900|NCT02809183|183207200|OTHER|Single-group test|Group LS mean|3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.5||The null hypothesis is the 4.5g TRC101 BID treatment group mean change from baseline = 0 mEq/L|Mixed Models Analysis|||||4.5|2.9|< 0.0001
91656901|NCT02809183|183207201|OTHER|Two-group test|Difference between group LS means|3.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.3|4.5||The null hypothesis is the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.5|2.3|< 0.0001
91656902|NCT02809183|183207201|OTHER|Two-group test|Difference between group LS means|3.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.2|4.3||The null hypothesis is the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.3|2.2|< 0.0001
91656903|NCT02809183|183207201|OTHER|Two-group test|Difference between group LS means|3.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.9|5.0||The null hypothesis is the difference between the treatment groups (4.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||5.0|2.9|< 0.0001
91527463|NCT04091360|182930128|OTHER||GeoMean Ratio|1.074||||0.0115|TWO_SIDED|95.0|1.017|1.134|||ANCOVA|||||1.134|1.017|0.0115
91656904|NCT02809183|183207202|OTHER|Single-group test|Group LS mean|3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|3.0|3.7||The null hypothesis is that the mean change from baseline within the Combined TRC101 treatment group = 0 mEq/L.|Mixed Models Analysis|||||3.7|3.0|< 0.0001
91712085|NCT03428100|183315788|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.078||0.044|TWO_SIDED|95.0|-12.26|-0.16|||Mixed Models Analysis|||||-0.16|-12.26|0.044
91712086|NCT03428100|183315788|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.632||0.037|TWO_SIDED|95.0|-10.67|-0.32|||Mixed Models Analysis|||||-0.32|-10.67|0.037
91712087|NCT03428100|183315788|SUPERIORITY||Mean Difference (Final Values)|-8.41|STANDARD_ERROR_OF_MEAN|3.03||0.006|TWO_SIDED|95.0|-14.37|-2.45|||Mixed Models Analysis|||||-2.45|-14.37|0.006
91712088|NCT03428100|183315789|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
91712089|NCT03428100|183315789|SUPERIORITY|||||||0.797|||||||Fisher Exact|||||||0.797
91712090|NCT03428100|183315789|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
91712091|NCT03428100|183315790|SUPERIORITY||Mean Difference (Final Values)|8.62|STANDARD_ERROR_OF_MEAN|4.49||0.056|TWO_SIDED|95.0|-0.22|17.45|||ANCOVA|||||17.45|-0.22|0.056
91712092|NCT03428100|183315790|SUPERIORITY||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.92||0.164|TWO_SIDED|95.0|-2.24|13.19|||ANCOVA|||||13.19|-2.24|0.164
91527464|NCT04091360|182930128|OTHER||GeoMean Ratio|1.037||||0.18|TWO_SIDED|95.0|0.982|1.096|||ANCOVA|||||1.096|0.982|0.18
91616220|NCT01953328|183125855|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.6|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-76.5|-62.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.6|-76.5|<0.001
91616221|NCT01953328|183125855|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-73.8|-57.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-57.1|-73.8|<0.001
91616222|NCT01953328|183125856|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.67|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-73.06|-64.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.27|-73.06|<0.001
91616223|NCT01953328|183125856|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.95|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-69.74|-62.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.16|-69.74|<0.001
91616224|NCT01953328|183125856|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.14|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-73.3|-62.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.99|-73.30|<0.001
91616225|NCT01953328|183125856|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.28|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-71.14|-63.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.42|-71.14|<0.001
91616226|NCT01953328|183125857|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.93|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-73.96|-63.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.89|-73.96|<0.001
91616227|NCT01953328|183125857|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.58|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-67.96|-59.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.21|-67.96|<0.001
91616228|NCT01953328|183125857|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.82|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-74.79|-62.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.86|-74.79|<0.001
91616229|NCT01953328|183125857|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.89|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.78|-55.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.99|-65.78|<0.001
91616230|NCT01953328|183125858|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.44|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-68.49|-60.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.39|-68.49|<0.001
91616231|NCT01953328|183125858|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-63.3|-55.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.17|-63.30|<0.001
91616232|NCT01953328|183125858|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-64.87|-55.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.25|-64.87|<0.001
91656905|NCT02809183|183207203|OTHER|Two-group test|Difference between group LS means|3.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.8|4.4||The null hypothesis is that the difference between treatment groups (Combined TRC101 - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.4|2.8|< 0.0001
91656906|NCT02809183|183207204|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
91656907|NCT02809183|183207204|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
91527465|NCT04091360|182930129|OTHER||GeoMean Ratio|1.162|||<|0.0001|TWO_SIDED|95.0|1.122|1.203|||ANCOVA|||||1.203|1.122|<0.0001
91712093|NCT03428100|183315790|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|4.53||0.11|TWO_SIDED|95.0|-1.66|16.15|||ANCOVA|||||16.15|-1.66|0.110
91616233|NCT01953328|183125858|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.39|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-67.15|-59.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.62|-67.15|<0.001
91616234|NCT01953328|183125859|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.56|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-70.34|-60.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.79|-70.34|<0.001
91616235|NCT01953328|183125859|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.23|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-62.05|-52.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-52.40|-62.05|<0.001
91616236|NCT01953328|183125859|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.37|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-65.91|-54.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-54.83|-65.91|<0.001
91616237|NCT01953328|183125859|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.15|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-60.92|-51.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-51.39|-60.92|<0.001
91616238|NCT01953328|183125860|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.54|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-49.35|-41.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.73|-49.35|<0.001
91616239|NCT01953328|183125860|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.43|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-46.78|-40.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.08|-46.78|<0.001
91616240|NCT01953328|183125860|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.98|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-44.88|-37.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.08|-44.88|<0.001
91616241|NCT01953328|183125860|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.14|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-46.48|-39.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.80|-46.48|<0.001
91616242|NCT01953328|183125861|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-49.83|-41.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.05|-49.83|<0.001
91616243|NCT01953328|183125861|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-41.34|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-44.84|-37.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.85|-44.84|<0.001
91616244|NCT01953328|183125861|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.96|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-45.35|-36.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-36.57|-45.35|<0.001
91616245|NCT01953328|183125861|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|1.93|<|0.001|TWO_SIDED|95.0|-42.26|-34.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.62|-42.26|<0.001
91616246|NCT01953328|183125862|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.77|STANDARD_ERROR_OF_MEAN|2.32|<|0.001|TWO_SIDED|95.0|-59.37|-50.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-50.17|-59.37|<0.001
91712094|NCT03428100|183315791|SUPERIORITY||Mean Difference (Final Values)|-48.06|STANDARD_ERROR_OF_MEAN|35.63||0.178|TWO_SIDED|95.0|-118.0|21.88|||ANOVA|||||21.88|-118.00|0.178
91527466|NCT04091360|182930129|OTHER||GeoMean Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.111|1.19|||ANCOVA|||||1.190|1.111|<0.0001
91527467|NCT04091360|182930129|OTHER||GeoMean Ratio|1.112|||<|0.0001|TWO_SIDED|95.0|1.074|1.152|||ANCOVA|||||1.152|1.074|<0.0001
91712095|NCT03428100|183315791|SUPERIORITY||Mean Difference (Final Values)|-56.9|STANDARD_ERROR_OF_MEAN|30.9||0.066|TWO_SIDED|95.0|-117.56|3.77|||ANOVA|||||3.77|-117.56|0.066
91656908|NCT02809183|183207204|OTHER|Two-group test||||||0.0074||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0074
91656909|NCT02809183|183207204|OTHER|Two-group test||||||0.0012||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||0.0012
91656910|NCT02809183|183207204|OTHER|Two-group test||||||0.0032||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0032
91656911|NCT02809183|183207204|OTHER|Two-group test||||||0.0013||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0013
91656912|NCT02809183|183207204|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
91656913|NCT02809183|183207204|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
91656914|NCT02809183|183207204|OTHER|Two-group test|||||<|0.0006||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||< 0.0006
91656915|NCT02809183|183207205|OTHER|Single-group test|Group LS mean|3.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.7|4.2||The null hypothesis is that the mean change from baseline within the 6g TRC101 QD group = 0 mEq/L.|Mixed Models Analysis|||||4.2|2.7|<0.0001
91656916|NCT02809183|183207206|OTHER|Two-group test|Difference between group LS means|3.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.6|4.7||The null hypothesis is the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.7|2.6|<0.0001
91656917|NCT02809183|183207207|OTHER|Two-group test|Difference between group LS means|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.4214|TWO_SIDED|95.0|-1.6|0.7||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - 6g TRC101 QD) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||0.7|-1.6|0.4214
91656918|NCT02809183|183207208|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
91656919|NCT02809183|183207208|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0003
91712096|NCT03428100|183315791|SUPERIORITY||Mean Difference (Final Values)|-71.42|STANDARD_ERROR_OF_MEAN|35.57||0.045|TWO_SIDED|95.0|-141.24|-1.6|||ANOVA|||||-1.60|-141.24|0.045
91656920|NCT02809183|183207208|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0003
91656921|NCT02933866|183207209|SUPERIORITY|||||||0.2961|||||||Cochran-Mantel-Haenszel|||||||0.2961
91656922|NCT00918567|183207210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p \< .10.|Mixed Models Analysis|Tukey-Kramer adjustments for post-hoc differences of least squares comparisons||||||<.05
91656923|NCT00918567|183207211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.51|<|0.05|TWO_SIDED|||||Also examined marginal effects, defined as p\<.10|Mixed Models Analysis|||||||<.05
91656924|NCT00918567|183207212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
91656925|NCT00918567|183207213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09|<|0.05|TWO_SIDED|||||Also estimated marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
91656926|NCT00918567|183207214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
91656927|NCT00918567|183207215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||>.05
91656928|NCT00918567|183207216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
91656929|NCT00918567|183207217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<0.05
91656930|NCT00918567|183207218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|1.8|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
91656931|NCT00918567|183207219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||Also tested marginal effect (p\<.10)|Mixed Models Analysis|||||||<.05
91656932|NCT00918567|183207220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.19|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
91712097|NCT03428100|183315792|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|6.62||0.088|TWO_SIDED|95.0|-24.33|1.7|||Mixed Models Analysis|||||1.70|-24.33|0.088
91712098|NCT03428100|183315792|SUPERIORITY||Mean Difference (Final Values)|-15.41|STANDARD_ERROR_OF_MEAN|5.725||0.007|TWO_SIDED|95.0|-26.67|-4.16|||Mixed Models Analysis|||||-4.16|-26.67|0.007
91712099|NCT03428100|183315792|SUPERIORITY||Mean Difference (Final Values)|-19.76|STANDARD_ERROR_OF_MEAN|6.583||0.003|TWO_SIDED|95.0|-32.71|-6.82|||Mixed Models Analysis|||||-6.82|-32.71|0.003
91616247|NCT01953328|183125862|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.66|STANDARD_ERROR_OF_MEAN|2.17|<|0.001|TWO_SIDED|95.0|-56.95|-48.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-48.36|-56.95|<0.001
91616248|NCT01953328|183125862|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.83|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-54.72|-46.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.93|-54.72|<0.001
91616249|NCT01953328|183125862|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.69|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-53.74|-45.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-45.64|-53.74|<0.001
91616250|NCT01953328|183125863|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.45|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-60.93|-49.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-49.98|-60.93|<0.001
91616251|NCT01953328|183125863|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.95|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-55.91|-46.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.00|-55.91|<0.001
91616252|NCT01953328|183125863|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.36|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-55.93|-46.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.80|-55.93|<0.001
91616253|NCT01953328|183125863|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-50.08|-40.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.81|-50.08|<0.001
91656933|NCT01988922|183207239|OTHER|Differences between CYP2B6\*1/\*1, CYP2B6\*1/\*6, and CYP2B6\*6/\*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.|||||<|0.05|||||||ANOVA|One-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons||||||<0.05
91527468|NCT04091360|182930130|OTHER||GeoMean Ratio|1.157|||<|0.0001|TWO_SIDED|95.0|1.119|1.196|||ANCOVA|||||1.196|1.119|<0.0001
91616254|NCT01953328|183125864|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.47|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-70.58|-62.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.36|-70.58|<0.001
91616255|NCT01953328|183125864|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.33|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-69.01|-59.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.66|-69.01|<0.001
91616256|NCT01953328|183125864|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.05|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-68.9|-59.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.20|-68.90|<0.001
91616257|NCT01953328|183125864|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.26|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-71.36|-63.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.15|-71.36|<0.001
91656934|NCT01600495|183207244|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||||||0.01
91656935|NCT01600495|183207245|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.25
91656936|NCT01600495|183207247|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|||Fisher's exact test||||<0.01
91656937|NCT04349917|183207267|SUPERIORITY|||||||0.532|||||||t-test, 2 sided|||||||0.532
91656938|NCT04349917|183207268|SUPERIORITY|||||||0.579|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.579
91656939|NCT04349917|183207268|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.034
91527469|NCT04091360|182930130|OTHER||GeoMean Ratio|1.147|||<|0.0001|TWO_SIDED|95.0|1.11|1.186|||ANCOVA|||||1.186|1.110|<0.0001
91656940|NCT04349917|183207269|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG regular task||||0.296
91656941|NCT04349917|183207269|SUPERIORITY|||||||0.169|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG reward task||||0.169
91656942|NCT04349917|183207270|SUPERIORITY|||||||0.118|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular commission rate||||0.118
91656943|NCT04349917|183207270|SUPERIORITY|||||||0.022|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular omission rate||||0.022
91656944|NCT04349917|183207270|SUPERIORITY|||||||0.22|||||||Pearson correlation|||Change in rest modularity vs Change in GNG regular RT Variability||||0.220
91616258|NCT01953328|183125865|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.29|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-72.75|-63.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.84|-72.75|<0.001
91616259|NCT01953328|183125865|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.53|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-68.11|-56.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-56.94|-68.11|<0.001
91616260|NCT01953328|183125865|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.97|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-69.44|-58.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-58.50|-69.44|<0.001
91616261|NCT01953328|183125865|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.62|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.51|-55.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.72|-65.51|<0.001
91616262|NCT01953328|183125866|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.8|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.8|<0.001
91616263|NCT01953328|183125866|SUPERIORITY_OR_OTHER||Treatment Difference|96.0|||<|0.001|TWO_SIDED|95.0|84.1|98.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||98.9|84.1|<0.001
91616264|NCT01953328|183125866|SUPERIORITY_OR_OTHER||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|57.1|83.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||83.4|57.1|<0.001
91616265|NCT01953328|183125866|SUPERIORITY_OR_OTHER||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|67.5|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||90.0|67.5|<0.001
91616266|NCT01953328|183125867|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.7|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.7|<0.001
91616267|NCT01953328|183125867|SUPERIORITY_OR_OTHER||Treatment Difference|91.8|||<|0.001|TWO_SIDED|95.0|78.2|96.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||96.0|78.2|<0.001
91616268|NCT01953328|183125867|SUPERIORITY_OR_OTHER||Treatment Difference|75.6|||<|0.001|TWO_SIDED|95.0|59.3|85.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||85.0|59.3|<0.001
91616269|NCT01953328|183125867|SUPERIORITY_OR_OTHER||Treatment Difference|78.0|||<|0.001|TWO_SIDED|95.0|62.6|86.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||86.9|62.6|<0.001
91616270|NCT01953328|183125868|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.2|STANDARD_ERROR_OF_MEAN|6.39|<|0.001|TWO_SIDED|95.0|-63.88|-38.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-38.52|-63.88|<0.001
91616271|NCT01953328|183125868|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.08|STANDARD_ERROR_OF_MEAN|4.94|<|0.001|TWO_SIDED|95.0|-58.89|-39.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.27|-58.89|<0.001
91616272|NCT01953328|183125868|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|5.14|<|0.001|TWO_SIDED|95.0|-59.74|-39.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.35|-59.74|<0.001
91616273|NCT01953328|183125868|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.93|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-53.75|-34.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.12|-53.75|<0.001
91656945|NCT04349917|183207270|SUPERIORITY|||||||0.496|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward commission rate||||0.496
91656946|NCT04349917|183207270|SUPERIORITY|||||||0.343|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward omission rate||||0.343
91656947|NCT04349917|183207270|SUPERIORITY|||||||0.988|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward RT variability||||0.988
91527470|NCT04091360|182930130|OTHER||GeoMean Ratio|1.105|||<|0.0001|TWO_SIDED|95.0|1.068|1.142|||ANCOVA|||||1.142|1.068|<0.0001
91656948|NCT04349917|183207270|SUPERIORITY|||||||0.892|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular commission rate||||0.892
91656949|NCT04349917|183207270|SUPERIORITY|||||||0.473|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular omission rate||||0.473
91656950|NCT04349917|183207270|SUPERIORITY|||||||0.409|||||||Pearson correlation|||Change in GNG regular modularity vs Change in GNG regular RT Variability||||0.409
91712100|NCT03428100|183315793|SUPERIORITY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|7.263||0.055|TWO_SIDED|95.0|-28.28|0.28|||Mixed Models Analysis|||||0.28|-28.28|0.055
91527471|NCT04091360|182930131|OTHER||GeoMean Ratio|1.098|||<|0.0001|TWO_SIDED|95.0|1.059|1.137|||ANCOVA|||||1.137|1.059|<0.0001
91616274|NCT01953328|183125869|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.07|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|95.0|-65.25|-34.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.90|-65.25|<0.001
91616275|NCT01953328|183125869|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-48.77|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-60.49|-37.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.05|-60.49|<0.001
91616276|NCT01953328|183125869|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.68|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-64.06|-41.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.30|-64.06|<0.001
91616277|NCT01953328|183125869|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.97|STANDARD_ERROR_OF_MEAN|5.29|<|0.001|TWO_SIDED|95.0|-50.46|-29.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-29.48|-50.46|<0.001
91616278|NCT01953328|183125870|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.93|STANDARD_ERROR_OF_MEAN|6.72|<|0.001|TWO_SIDED|95.0|-41.27|-14.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.59|-41.27|<0.001
91616279|NCT01953328|183125870|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-21.94|STANDARD_ERROR_OF_MEAN|5.34|<|0.001|TWO_SIDED|95.0|-32.54|-11.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.35|-32.54|<0.001
91616280|NCT01953328|183125870|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.01|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|95.0|-29.59|-10.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-10.43|-29.59|<0.001
91616281|NCT01953328|183125870|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.72|STANDARD_ERROR_OF_MEAN|6.78||0.01|TWO_SIDED|95.0|-34.18|-7.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-7.26|-34.18|0.010
91616282|NCT01953328|183125871|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.57|STANDARD_ERROR_OF_MEAN|9.45|<|0.001|TWO_SIDED|95.0|-46.33|-8.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.81|-46.33|<0.001
91616283|NCT01953328|183125871|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.97|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-31.68|-8.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.25|-31.68|<0.001
91656951|NCT04349917|183207270|SUPERIORITY|||||||0.351|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward commission rate||||0.351
91656952|NCT04349917|183207270|SUPERIORITY|||||||0.238|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward omission rate||||0.238
91527472|NCT04091360|182930131|OTHER||GeoMean Ratio|1.111|||<|0.0001|TWO_SIDED|95.0|1.072|1.15|||ANCOVA|||||1.150|1.072|<0.0001
91656953|NCT04349917|183207270|SUPERIORITY|||||||0.909|||||||Pearson correlation|||Change in GNG reward modularity vs Change in GNG reward RT Variability||||0.909
91656954|NCT04349917|183207271|SUPERIORITY|||||||0.806|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.806
91527473|NCT04091360|182930131|OTHER||GeoMean Ratio|1.07||||0.0003|TWO_SIDED|5.0|1.033|1.109|||ANCOVA|||||1.109|1.033|0.0003
91656955|NCT04349917|183207271|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.003
91656956|NCT04349917|183207272|SUPERIORITY|||||||0.093|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.093
91656957|NCT04349917|183207272|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
91656958|NCT04349917|183207273|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.075
91656959|NCT04349917|183207273|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
91712101|NCT03428100|183315793|SUPERIORITY||Mean Difference (Final Values)|-14.76|STANDARD_ERROR_OF_MEAN|6.297||0.02|TWO_SIDED|95.0|-27.15|-2.38|||Mixed Models Analysis|||||-2.38|-27.15|0.020
91712102|NCT03428100|183315793|SUPERIORITY||Mean Difference (Final Values)|-17.82|STANDARD_ERROR_OF_MEAN|7.216||0.014|TWO_SIDED|95.0|-32.01|-3.62|||Mixed Models Analysis|||||-3.62|-32.01|0.014
91616284|NCT01953328|183125871|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-17.17|STANDARD_ERROR_OF_MEAN|5.53|<|0.001|TWO_SIDED|95.0|-28.15|-6.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-6.19|-28.15|<0.001
91616285|NCT01953328|183125871|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.92|STANDARD_ERROR_OF_MEAN|7.24||0.01|TWO_SIDED|95.0|-31.29|-2.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-2.56|-31.29|0.010
91616286|NCT01953328|183125872|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|12.33|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|7.39|17.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||17.27|7.39|<0.001
91616287|NCT01953328|183125872|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|14.61|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|9.93|19.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.30|9.93|<0.001
91616288|NCT01953328|183125872|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.36|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|10.12|20.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.60|10.12|<0.001
91616289|NCT01953328|183125872|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.15|STANDARD_ERROR_OF_MEAN|2.26||0.001|TWO_SIDED|95.0|4.67|13.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||13.62|4.67|0.001
91616290|NCT01953328|183125873|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|13.46|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|7.4|19.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.53|7.40|<0.001
91616291|NCT01953328|183125873|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.2|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|9.87|20.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.52|9.87|<0.001
91616292|NCT01953328|183125873|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|16.85|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|10.74|22.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||22.95|10.74|<0.001
91616293|NCT01953328|183125873|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|10.2|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|95.0|4.85|15.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||15.55|4.85|0.001
91616294|NCT01953328|183125874|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.85|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-39.37|-16.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-16.34|-39.37|<0.001
91616295|NCT01953328|183125874|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.65|STANDARD_ERROR_OF_MEAN|5.17|<|0.001|TWO_SIDED|95.0|-32.91|-12.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-12.39|-32.91|<0.001
91616296|NCT01953328|183125874|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.69||0.001|TWO_SIDED|95.0|-27.4|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.77|-27.40|0.001
91616297|NCT01953328|183125874|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|6.12|<|0.001|TWO_SIDED|95.0|-39.31|-15.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-15.01|-39.31|<0.001
91616298|NCT01953328|183125875|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-42.48|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.36|-42.48|<0.001
91616299|NCT01953328|183125875|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.81|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.29|-9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-9.33|-32.29|<0.001
91712103|NCT03428100|183315794|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|1.229||0.095|TWO_SIDED|95.0|-4.47|-0.36|||Mixed Models Analysis|||||-0.36|-4.47|0.095
91712104|NCT03428100|183315794|SUPERIORITY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.057||0.004|TWO_SIDED|95.0|-5.16|-1.01|||Mixed Models Analysis|||||-1.01|-5.16|0.004
91712105|NCT03428100|183315794|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.216|<|0.001|TWO_SIDED|95.0|-7.48|-2.7|||Mixed Models Analysis|||||-2.70|-7.48|<0.001
91616300|NCT01953328|183125875|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.05|STANDARD_ERROR_OF_MEAN|5.37||0.001|TWO_SIDED|95.0|-25.72|-4.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-4.39|-25.72|0.001
91616301|NCT01953328|183125875|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.35|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-36.7|-11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.99|-36.70|<0.001
91616302|NCT05113953|183125886|SUPERIORITY||Treatment Difference|-0.42||||0.1893|TWO_SIDED|95.0|-1.06|0.21||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.21|-1.06|0.1893
91616303|NCT05113953|183125886|SUPERIORITY||Treatment Difference|-0.06||||0.8502|TWO_SIDED|95.0|-0.69|0.57||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.57|-0.69|0.8502
91616304|NCT05113953|183125887|SUPERIORITY||Treatment Difference|-0.54||||0.0313|TWO_SIDED|95.0|-1.02|-0.05||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||-0.05|-1.02|0.0313
91616305|NCT05113953|183125887|SUPERIORITY||Treatment Difference|0.19||||0.4471|TWO_SIDED|95.0|-0.3|0.67||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||0.67|-0.30|0.4471
91616306|NCT03987919|183125914|SUPERIORITY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.64|-0.38|||Mixed Models Analysis|||||-0.38|-0.64|<0.001
91616307|NCT03987919|183125914|SUPERIORITY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.73|-0.47|||Mixed Models Analysis|||||-0.47|-0.73|<0.001
91616308|NCT03987919|183125915|SUPERIORITY||LS Mean Difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||Mixed Models Analysis|||||-0.10|-0.36|<0.001
91616309|NCT03987919|183125916|SUPERIORITY||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|<0.001
91616310|NCT03987919|183125916|SUPERIORITY||LS Mean Difference|-4.1|||<|0.001|TWO_SIDED|95.0|-5.0|-3.2|||Mixed Models Analysis|||||-3.2|-5.0|<0.001
91616311|NCT03987919|183125916|SUPERIORITY||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-7.1|-5.3|||Mixed Models Analysis|||||-5.3|-7.1|<0.001
91616312|NCT03987919|183125917|SUPERIORITY||Odds Ratio (OR)|1.54||||0.023|TWO_SIDED|95.0|1.06|2.23|||Regression, Logistic|||||2.23|1.06|0.023
91616313|NCT03987919|183125917|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.44|3.17|||Regression, Logistic|||||3.17|1.44|<0.001
91616314|NCT03987919|183125917|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.97|4.66|||Regression, Logistic|||||4.66|1.97|<0.001
91527474|NCT04091360|182930132|OTHER||Median Difference (Final Values)|8.5||||0.47|TWO_SIDED||||||Hodges-Lehmann|||||||0.47
91616315|NCT03987919|183125918|SUPERIORITY||LS Mean Difference|-7.3||||0.001|TWO_SIDED|95.0|-11.7|-3.0|||Mixed Models Analysis|||||-3.0|-11.7|0.001
91616316|NCT03987919|183125918|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-17.4|-8.6|||Mixed Models Analysis|||||-8.6|-17.4|<0.001
91616317|NCT03987919|183125918|SUPERIORITY||LS Mean Difference|-14.7|||<|0.001|TWO_SIDED|95.0|-19.1|-10.3|||Mixed Models Analysis|||||-10.3|-19.1|<0.001
91616318|NCT03987919|183125920|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.2|2.08|||Regression, Logistic|||||2.08|1.20|0.001
91616319|NCT03987919|183125920|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|2.57|4.75|||Regression, Logistic|||||4.75|2.57|<0.001
91616320|NCT03987919|183125920|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|3.32|6.38|||Regression, Logistic|||||6.38|3.32|<0.001
91527475|NCT04091360|182930132|OTHER||Mean Difference (Final Values)|18.0||||0.0059|TWO_SIDED||||||Hodges-Lehmann|||||||0.0059
91616321|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.24||||0.084|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Hyperglycemia||0.03|-0.50|0.084
91616322|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.27||||0.05|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Hyperglycemia||0.00|-0.54|0.050
91616323|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.39||||0.005|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA|||Hyperglycemia||-0.12|-0.66|0.005
91616324|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.06||||0.688|TWO_SIDED|95.0|-0.33|0.22|||ANCOVA|||Hypoglycemia||0.22|-0.33|0.688
91616325|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.02||||0.909|TWO_SIDED|95.0|-0.29|0.26|||ANCOVA|||Hypoglycemia||0.26|-0.29|0.909
91712106|NCT03428100|183315795|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.146||0.097|TWO_SIDED|95.0|-0.53|0.04|||Mixed Models Analysis|||||0.04|-0.53|0.097
91712107|NCT03428100|183315795|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.126||0.033|TWO_SIDED|95.0|-0.52|-0.02|||Mixed Models Analysis|||||-0.02|-0.52|0.033
91712108|NCT03428100|183315795|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.86|-0.29|||Mixed Models Analysis|||||-0.29|-0.86|<0.001
91712109|NCT03428100|183315796|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.516||0.272|TWO_SIDED|95.0|-1.58|0.45|||Mixed Models Analysis|||Anxiety||0.45|-1.58|0.272
91616326|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.13||||0.358|TWO_SIDED|95.0|-0.4|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.40|0.358
91616327|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.1||||0.701|TWO_SIDED|95.0|-0.62|0.41|||ANCOVA|||Total Score||0.41|-0.62|0.701
91616328|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|-0.25||||0.341|TWO_SIDED|95.0|-0.78|0.27|||ANCOVA|||Total Score||0.27|-0.78|0.341
91616329|NCT03987919|183125921|SUPERIORITY||LS Mean Difference|0.26||||0.321|TWO_SIDED|95.0|-0.26|0.79|||ANCOVA|||Total Score||0.79|-0.26|0.321
91616330|NCT03987919|183125923|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.35|2.57|||Regression, Logistic|||||2.57|1.35|<0.001
91616331|NCT03987919|183125923|SUPERIORITY||Odds Ratio (OR)|3.94|||<|0.001|TWO_SIDED|95.0|2.88|5.39|||Regression, Logistic|||||5.39|2.88|<0.001
91616332|NCT03987919|183125923|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|3.73|6.97|||Regression, Logistic|||||6.97|3.73|<0.001
91616333|NCT03470922|183125931|SUPERIORITY||Cox Proportional Hazard|0.75||||0.0055|TWO_SIDED|95.0|0.62|0.92|||Log Rank|Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])||||0.92|0.62|0.0055
91616334|NCT02626819|183125940|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
91616335|NCT02626819|183125941|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.||||||<0.05
91616336|NCT02626819|183125942|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
91616337|NCT02626819|183125943|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91616338|NCT02626819|183125944|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91616339|NCT02626819|183125945|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91616340|NCT02626819|183125946|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91616341|NCT02626819|183125947|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91616342|NCT02361762|183125972|OTHER|||||||0.36|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.36
91616343|NCT02361762|183125973|OTHER|||||||0.79|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.79
91616344|NCT02361762|183125974|OTHER|||||||0.009|||||||ANOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Congruent/Incongruent)||||||0.009
91616345|NCT02361762|183125975|OTHER|||||||0.79||||||ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|ANCOVA|Compared scores at post testing with baseline scores covaried.||||||.79
91616346|NCT02361762|183125976|OTHER|||||||0.61|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.61
91616347|NCT02361762|183125977|OTHER|||||||0.68|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)0.||||||0.68
91616348|NCT02361762|183125978|OTHER|||||||0.54|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.54
91616349|NCT02361762|183125979|OTHER|||||||0.08|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.08
91616350|NCT02361762|183125980|OTHER|||||||0.37|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.37
91616351|NCT02361762|183125982|OTHER|||||||0.62|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.62
91616352|NCT02361762|183125983|OTHER|||||||0.1|||||||ANCOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Go/Nogo)||||||0.10
91616353|NCT02361762|183125984|OTHER|||||||0.02|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.02
91616354|NCT01328249|183125985|OTHER|Fisher's Exact test||||||0.4422||||||Null hypothesis: The feasibility rates of Cohort 1 and Cohort 2 are same.|Fisher Exact|Exploratory analysis comparing primary feasibilities between 2 cohorts, based on Fisher's Exact test.||||||0.4422
91616355|NCT00502307|183125988|OTHER||Exact binomial distribution|24.6|||||TWO_SIDED|95.0|19.6|30.2||||||||30.2|19.6|
91616356|NCT00502307|183125988|OTHER||Exact binomial distribution|18.0|||||TWO_SIDED|95.0|13.6|23.1||||||||23.1|13.6|
91616357|NCT00502307|183125989|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91616358|NCT00502307|183125989|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91616359|NCT00502307|183125990|OTHER|||||||0.005|||||||Log Rank|||||||0.005
91616360|NCT00502307|183125990|OTHER|||||||0.129|||||||Log Rank|||||||0.129
91616361|NCT00502307|183125991|OTHER|||||||0.003|||||||Log Rank|||||||0.003
91616362|NCT00502307|183125991|OTHER|||||||0.089|||||||Log Rank|||||||0.089
91616363|NCT02330549|183125995|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.2286|STANDARD_ERROR_OF_MEAN|0.195||0.2483|TWO_SIDED|95.0|-0.62|0.17||An analysis of covariance (ANCOVA) model that included treatment and presence or absence of nonalcoholic steatohepatitis (NASH) as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||0.17|-0.62|0.2483
91616364|NCT02330549|183125995|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.4113|STANDARD_ERROR_OF_MEAN|0.205||0.053|TWO_SIDED|95.0|-0.83|0.01||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change form Baseline to Week 24||0.01|-0.83|0.053
91712110|NCT03428100|183315796|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.446||0.013|TWO_SIDED|95.0|-1.99|-0.24|||Mixed Models Analysis|||Anxiety||-0.24|-1.99|0.013
91712111|NCT03428100|183315796|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.511||0.099|TWO_SIDED|95.0|-1.85|0.16|||Mixed Models Analysis|||Anxiety||0.16|-1.85|0.099
91616365|NCT02330549|183125996|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-1.505|STANDARD_ERROR_OF_MEAN|2.369||0.5297|TWO_SIDED|95.0|-6.33|3.32||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||3.32|-6.33|0.5297
91616366|NCT02330549|183125996|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|3.2146|STANDARD_ERROR_OF_MEAN|2.757||0.2522|TWO_SIDED|95.0|-2.4|8.83||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 24||8.83|-2.4|0.2522
91616367|NCT02713230|183126111|SUPERIORITY||LSMD|-117.688|||<|0.0001|TWO_SIDED|95.0|-150.896|-84.48|||ANOVA|||||-84.480|-150.896|<0.0001
91616368|NCT02713230|183126112|SUPERIORITY||LSM treatment ratio|0.22|||<|0.0001|TWO_SIDED|95.0|0.131|0.371|||ANOVA|||||0.371|0.131|<0.0001
91656960|NCT02532764|183207314|SUPERIORITY||Difference vs placebo|12.91|STANDARD_ERROR_OF_MEAN|6.53||0.0592|TWO_SIDED|95.0|-0.54|26.35||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||26.35|-0.54|0.0592
91656961|NCT02532764|183207314|SUPERIORITY||difference vs placebo|19.13|STANDARD_ERROR_OF_MEAN|6.56||0.0074|TWO_SIDED|95.0|5.62|32.64||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||32.64|5.62|0.0074
91616369|NCT02713230|183126113|SUPERIORITY||Treatment difference|0.116||||0.008|TWO_SIDED|95.0|0.032|0.2|||Cochran-Mantel-Haenszel|||||0.200|0.032|0.008
91616370|NCT02713230|183126114|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
91616371|NCT00769704|183126118|SUPERIORITY_OR_OTHER||Treatment Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.3|19.0|||Fisher Exact|||The null hypothesis was that there was no difference in the durable response rate between the talimogene laherparepvec and control arms. Study success was defined as the rejection of this hypothesis such that talimogene laherparepvec was found to be superior to GM-CSF using the 2-sided Fisher's exact test, with a p-value of ≤ 0.0488.||19.0|9.3|<0.0001
91616372|NCT00769704|183126119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0511|TWO_SIDED|95.0|0.62|1.0|||Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.|The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.||1.00|0.62|0.0511
91616373|NCT00769704|183126120|SUPERIORITY_OR_OTHER||Treatment Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.4|27.1||Descriptive|Fisher Exact|||||27.1|14.4|<0.0001
91616374|NCT00769704|183126121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0868|TWO_SIDED|95.0|0.14|1.18||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average duration of response for talimogene laherparepvec relative to GM-CSF.|||1.18|0.14|0.0868
91616375|NCT00769704|183126122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.202|TWO_SIDED|95.0|0.3|1.3||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \> 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.|||1.30|0.30|0.2020
91616376|NCT00769704|183126123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.32|0.54||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.|||0.54|0.32|<0.0001
91616377|NCT00769704|183126124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.005|TWO_SIDED|95.0|0.13|0.73||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.|||0.73|0.13|0.0050
91616378|NCT00520676|183126125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||The comparison was conducted at a 1-sided significance level of 0.05.|Log Rank|Note that the 2-sided p-value for log rank is reported, which is \<0.001, hence 1-sided p-value is \<0.001.|Cox regression model is used for HR estimate.|||0.60|0.34|<0.001
91712112|NCT03428100|183315796|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.519||0.584|TWO_SIDED|95.0|-1.3|0.74|||Mixed Models Analysis|||Depression||0.74|-1.30|0.584
91712113|NCT03428100|183315796|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.448||0.162|TWO_SIDED|95.0|-1.51|0.25|||Mixed Models Analysis|||Depression||0.25|-1.51|0.162
91712114|NCT03428100|183315796|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.515||0.024|TWO_SIDED|95.0|-2.18|-0.15|||Mixed Models Analysis|||Depression||-0.15|-2.18|0.024
91616379|NCT00520676|183126126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.934|TWO_SIDED|95.0|0.72|1.42||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.42|0.72|0.934
91712115|NCT03428100|183315797|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.018||0.228|TWO_SIDED|95.0|-3.23|0.77|||Mixed Models Analysis|||||0.77|-3.23|0.228
91712116|NCT03428100|183315797|SUPERIORITY||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|0.876||0.065|TWO_SIDED|95.0|-3.35|0.1|||Mixed Models Analysis|||||0.10|-3.35|0.065
91712117|NCT03428100|183315797|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.007||0.003|TWO_SIDED|95.0|-4.99|-1.02|||Mixed Models Analysis|||||-1.02|-4.99|0.003
91712118|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|3.339||0.784|TWO_SIDED|95.0|-7.5|5.67|||Mixed Models Analysis|||Change from Baseline (CFB) Absenteeism||5.67|-7.50|0.784
91712119|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|2.813||0.525|TWO_SIDED|95.0|-3.75|7.34|||Mixed Models Analysis|||CFB Absenteeism||7.34|-3.75|0.525
91712120|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|3.204||0.947|TWO_SIDED|95.0|-6.11|6.53|||Mixed Models Analysis|||CFB Absenteeism||6.53|-6.11|0.947
91616380|NCT00520676|183126127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8|TWO_SIDED|95.0|0.72|1.29||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank|Cox regression model is used for hazard ratio (HR) estimate.||||1.29|0.72|0.800
91616381|NCT00520676|183126128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.081|TWO_SIDED|95.0|0.93|3.15||The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.|Fisher Exact|Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.|Logistic regression model is used for odds ratio (OR) estimate.|||3.15|0.93|0.081
91616382|NCT00520676|183126129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.641|TWO_SIDED|95.0|0.49|1.55||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.55|0.49|0.641
91616383|NCT00520676|183126130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.71|0.40|<0.001
91616384|NCT00520676|183126131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.66||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.66|0.35|<0.001
91616385|NCT01533935|183126150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.215|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.315|0.215|<0.0001
91656962|NCT02532764|183207314|SUPERIORITY||difference vs placebo|14.24|STANDARD_ERROR_OF_MEAN|6.6||0.0408|TWO_SIDED|95.0|0.64|27.83||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||27.83|0.64|0.0408
91656963|NCT02532764|183207314|SUPERIORITY||difference vs placebo|3.46|STANDARD_ERROR_OF_MEAN|6.87||0.6193|TWO_SIDED|95.0|-10.69|17.6||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||17.60|-10.69|0.6193
91616386|NCT01533935|183126150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.025||0.0015|TWO_SIDED|95.0|0.031|0.129|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.129|0.031|0.0015
91616387|NCT01533935|183126150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0005|TWO_SIDED|95.0|0.039|0.137|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.137|0.039|0.0005
91616388|NCT01533935|183126150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.224|0.324|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.324|0.224|<0.0001
91616389|NCT01533935|183126150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|0.039|0.138|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.138|0.039|0.0004
91616390|NCT01533935|183126150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.047|0.147|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.147|0.047|0.0001
91656964|NCT02532764|183207316|SUPERIORITY||Difference vs placebo|23.17|STANDARD_ERROR_OF_MEAN|9.73||0.0321|TWO_SIDED|95.0|2.29|44.04||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||44.04|2.29|0.0321
91656965|NCT02532764|183207316|SUPERIORITY||Difference vs placebo|27.3|STANDARD_ERROR_OF_MEAN|9.17||0.01|TWO_SIDED|95.0|7.64|46.96||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||46.96|7.64|0.0100
91712121|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|4.409||0.488|TWO_SIDED|95.0|-5.62|11.74|||Mixed Models Analysis|||CFB Presenteeism||11.74|-5.62|0.488
91712122|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.72||0.936|TWO_SIDED|95.0|-7.02|7.62|||Mixed Models Analysis|||CFB Presenteeism||7.62|-7.02|0.936
91712123|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|4.267||0.991|TWO_SIDED|95.0|-8.35|8.45|||Mixed Models Analysis|||CFB Presenteeism||8.45|-8.35|0.991
91616391|NCT01533935|183126151|SUPERIORITY_OR_OTHER||Ratio|1.134|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|1.065|1.206|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.206|1.065|<0.0001
91616392|NCT01533935|183126151|SUPERIORITY_OR_OTHER||Ratio|1.111|STANDARD_ERROR_OF_MEAN|0.035||0.0009|TWO_SIDED|95.0|1.045|1.182|||Mixed Models Analysis||Ratio calculated Tiotropium + olodaterol 5/5 QD as divided by Olodaterol 5 mcg QD|||1.182|1.045|0.0009
91616393|NCT01533935|183126151|SUPERIORITY_OR_OTHER||Ratio|1.043|STANDARD_ERROR_OF_MEAN|0.033||0.1807|TWO_SIDED|95.0|0.981|1.109|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.109|0.981|0.1807
91616394|NCT01533935|183126151|SUPERIORITY_OR_OTHER||Ratio|1.121|STANDARD_ERROR_OF_MEAN|0.036||0.0003|TWO_SIDED|95.0|1.054|1.193|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.193|1.054|0.0003
91791353|NCT03720652|183460431|OTHER|The statistical test is a paired test assessing change at the End-of-Program Interview relative to baseline.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.002
91616395|NCT01533935|183126151|SUPERIORITY_OR_OTHER||Ratio|1.099|STANDARD_ERROR_OF_MEAN|0.035||0.0029|TWO_SIDED|95.0|1.033|1.17|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.170|1.033|0.0029
91712124|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|4.938||0.816|TWO_SIDED|95.0|-8.57|10.88|||Mixed Models Analysis|||CFB Work Productivity Loss||10.88|-8.57|0.816
91712125|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|4.178||0.971|TWO_SIDED|95.0|-8.08|8.38|||Mixed Models Analysis|||CFB Work Productivity Loss||8.38|-8.08|0.971
91712126|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|4.804||0.852|TWO_SIDED|95.0|-10.36|8.56|||Mixed Models Analysis|||CFB Work Productivity Loss||8.56|-10.36|0.852
91712127|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|3.877||0.607|TWO_SIDED|95.0|-9.61|5.63|||Mixed Models Analysis|||CFB Activity Impairment||5.63|-9.61|0.607
91616396|NCT01533935|183126151|SUPERIORITY_OR_OTHER||Ratio|1.032|STANDARD_ERROR_OF_MEAN|0.033||0.324|TWO_SIDED|95.0|0.97|1.098|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.098|0.970|0.3240
91616397|NCT01533935|183126152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.004|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.002|-0.004|<0.0001
91616398|NCT01533935|183126152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0033|TWO_SIDED|95.0|-0.003|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.003|0.0033
91656966|NCT02532764|183207316|SUPERIORITY||Difference vs placebo|20.16|STANDARD_ERROR_OF_MEAN|8.62||0.0346|TWO_SIDED|95.0|1.68|38.64||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||38.64|1.68|0.0346
91656967|NCT02532764|183207316|SUPERIORITY||Difference vs placebo|10.84|STANDARD_ERROR_OF_MEAN|9.01||0.2485|TWO_SIDED|95.0|-8.47|30.16||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||30.16|-8.47|0.2485
91616399|NCT01533935|183126152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2306|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.2306
91616400|NCT01533935|183126152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
91616401|NCT01533935|183126152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.001|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.004|0.0010
91656968|NCT02532764|183207318|SUPERIORITY||difference vs placebo|4.24|STANDARD_ERROR_OF_MEAN|3.18||0.1938|TWO_SIDED|95.0|-2.3|10.79||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariate||10.79|-2.30|0.1938
91712128|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|3.319||0.186|TWO_SIDED|95.0|-10.92|2.12|||Mixed Models Analysis|||CFB Activity Impairment||2.12|-10.92|0.186
91616402|NCT01533935|183126152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.1206|TWO_SIDED|95.0|-0.002|0.0|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.000|-0.002|0.1206
91616403|NCT01533935|183126153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.294|0.364|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.364|0.294|<0.0001
91616404|NCT01533935|183126153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.099|0.169|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.169|0.099|<0.0001
91616405|NCT01533935|183126153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.1|0.17|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.170|0.100|<0.0001
91712129|NCT03428100|183315798|SUPERIORITY||Mean Difference (Final Values)|-7.45|STANDARD_ERROR_OF_MEAN|3.82||0.052|TWO_SIDED|95.0|-14.96|0.06|||Mixed Models Analysis|||CFB Activity Impairment||0.06|-14.96|0.052
91712130|NCT03428100|183315799|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.022||0.131|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|-0.01|0.131
91712131|NCT03428100|183315799|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.017|TWO_SIDED|95.0|0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|0.01|0.017
91712132|NCT03428100|183315799|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.003|TWO_SIDED|95.0|0.02|0.11|||Mixed Models Analysis|||CFB US Health State Index||0.11|0.02|0.003
91791354|NCT03720652|183460432|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.022|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.022
91791355|NCT03720652|183460432|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
91616406|NCT01533935|183126153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.269|0.34|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.340|0.269|<0.0001
91616407|NCT01533935|183126153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.075|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.075|<0.0001
91616408|NCT01533935|183126153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.076|0.146|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.146|0.076|<0.0001
91616409|NCT00818324|183126154|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2|t-test, 2 sided|||||||<0.001
91616410|NCT00818324|183126154|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
91656969|NCT02532764|183207318|SUPERIORITY||difference vs placebo|2.75|STANDARD_ERROR_OF_MEAN|3.18||0.3943|TWO_SIDED|95.0|-3.79|9.29||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||9.29|-3.79|0.3943
91656970|NCT02532764|183207318|SUPERIORITY||difference vs placebo|0.53|STANDARD_ERROR_OF_MEAN|3.18||0.8688|TWO_SIDED|95.0|-6.01|7.07||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||7.07|-6.01|0.8688
91712133|NCT03428100|183315799|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.031||0.102|TWO_SIDED|95.0|-0.01|0.11|||Mixed Models Analysis|||CFB UK Health State Index||0.11|-0.01|0.102
91616411|NCT00818324|183126154|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
91656971|NCT02532764|183207318|SUPERIORITY||difference vs placebo|-0.51|STANDARD_ERROR_OF_MEAN|3.35||0.8813|TWO_SIDED|95.0|-7.41|6.39||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||6.39|-7.41|0.8813
91712134|NCT03428100|183315799|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.014|TWO_SIDED|95.0|0.01|0.12|||Mixed Models Analysis|||CFB UK Health State Index||0.12|0.01|0.014
91616412|NCT00818324|183126154|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
91616413|NCT00818324|183126155|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2.|t-test, 2 sided|||||||<0.001
91616414|NCT00818324|183126155|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
91616415|NCT00818324|183126155|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
91616416|NCT00818324|183126155|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
91616417|NCT02389816|183126179|SUPERIORITY||Least square (LS) mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.999||0.008|TWO_SIDED|95.0|-4.63|-0.7|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-0.70|-4.63|0.0080
91712135|NCT03428100|183315799|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.031||0.003|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|||CFB UK Health State Index||0.15|0.03|0.003
91712136|NCT03428100|183315800|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|3.256||0.221|TWO_SIDED|95.0|-2.41|10.39|||Mixed Models Analysis|||||10.39|-2.41|0.221
91712137|NCT03428100|183315800|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.807||0.689|TWO_SIDED|95.0|-4.4|6.65|||Mixed Models Analysis|||||6.65|-4.40|0.689
91712138|NCT03428100|183315800|SUPERIORITY||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|3.226||0.294|TWO_SIDED|95.0|-2.95|9.74|||Mixed Models Analysis|||||9.74|-2.95|0.294
91712139|NCT03428100|183315801|SUPERIORITY||Odds Ratio (OR)|1.33||||0.382|TWO_SIDED|95.0|0.7|2.54|||Regression, Logistic|||||2.54|0.70|0.382
91712140|NCT03428100|183315801|SUPERIORITY||Odds Ratio (OR)|1.15||||0.638|TWO_SIDED|95.0|0.65|2.02|||Regression, Logistic|||||2.02|0.65|0.638
91712141|NCT03428100|183315801|SUPERIORITY||Odds Ratio (OR)|1.56||||0.169|TWO_SIDED|95.0|0.83|2.96|||Regression, Logistic|||||2.96|0.83|0.169
91712142|NCT03428100|183315802|SUPERIORITY||LS Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|9.674||0.447|TWO_SIDED|95.0|-26.38|11.66|||Regression, Linear|||||11.66|-26.38|0.447
91616418|NCT02389816|183126179|SUPERIORITY||LS mean difference|-3.07|STANDARD_ERROR_OF_MEAN|1.003||0.0023|TWO_SIDED|95.0|-5.05|-1.1|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-1.10|-5.05|0.0023
91616419|NCT02389816|183126180|SUPERIORITY||Odds Ratio (OR)|1.621||||0.0341|TWO_SIDED|95.0|1.037|2.533|||Regression, Logistic|||||2.533|1.037|0.0341
91616420|NCT02389816|183126180|SUPERIORITY||Odds Ratio (OR)|1.788||||0.011||95.0|1.143|2.799|||Regression, Logistic|||||2.799|1.143|0.0110
91616421|NCT02389816|183126181|SUPERIORITY||Odds Ratio (OR)|1.839||||0.0186|TWO_SIDED|95.0|1.107|3.054|||Regression, Logistic|||||3.054|1.107|0.0186
91616422|NCT02389816|183126181|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0418|TWO_SIDED|95.0|1.02|2.834|||Regression, Logistic|||||2.834|1.020|0.0418
91616423|NCT02389816|183126182|SUPERIORITY||LS mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.753||0.0165|TWO_SIDED|95.0|-3.29|-0.332|||ANCOVA|||||-0.332|-3.290|0.0165
91616424|NCT02389816|183126182|SUPERIORITY||LS mean difference|-1.79|STANDARD_ERROR_OF_MEAN|0.759||0.019|TWO_SIDED|95.0|-3.278|-0.295|||ANCOVA|||||-0.295|-3.278|0.0190
91712143|NCT03428100|183315802|SUPERIORITY||LS Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|8.454||0.646|TWO_SIDED|95.0|-20.5|12.74|||Regression, Linear|||||12.74|-20.50|0.646
91712144|NCT03428100|183315802|SUPERIORITY||LS Mean Difference (Final Values)|-17.18|STANDARD_ERROR_OF_MEAN|9.64||0.075|TWO_SIDED|95.0|-36.14|1.77|||Regression, Linear|||||1.77|-36.14|0.075
91616425|NCT02389816|183126183|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0031|TWO_SIDED|95.0|-0.59|-0.121|||ANCOVA|||||-0.121|-0.590|0.0031
91616426|NCT02389816|183126183|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.629|-0.158|||ANCOVA|||||-0.158|-0.629|0.0011
91616427|NCT02389816|183126184|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0609|TWO_SIDED|95.0|-0.474|0.011|||ANCOVA|||||0.011|-0.474|0.0609
91616428|NCT02389816|183126184|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.124||0.0179|TWO_SIDED|95.0|-0.537|-0.051|||ANCOVA|||||-0.051|-0.537|0.0179
91616429|NCT02389816|183126185|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.621||0.0311|TWO_SIDED|95.0|-2.564|-0.122|||ANCOVA|||||-0.122|-2.564|0.0311
91616430|NCT02389816|183126185|SUPERIORITY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.628||0.0126|TWO_SIDED|95.0|-2.807|-0.339|||ANCOVA|||||-0.339|-2.807|0.0126
91616431|NCT02389816|183126186|SUPERIORITY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.893||0.3793|TWO_SIDED|95.0|-2.539|0.968|||ANCOVA|||||0.968|-2.539|0.3793
91616432|NCT02389816|183126186|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.891||0.9011|TWO_SIDED|95.0|-1.862|1.641|||ANCOVA|||||1.641|-1.862|0.9011
91616433|NCT02389816|183126187|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.329||0.0089|TWO_SIDED|95.0|-1.512|-0.218|||ANCOVA|||||-0.218|-1.512|0.0089
91616434|NCT02389816|183126187|SUPERIORITY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.332||0.0001|TWO_SIDED|95.0|-1.922|-0.619|||ANCOVA|||||-0.619|-1.922|0.0001
91616435|NCT00300469|183126188|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
91616436|NCT00300469|183126188|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
91616437|NCT00300469|183126189|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.005
91656972|NCT02532764|183207320|SUPERIORITY||Difference vs placebo|10.19|STANDARD_ERROR_OF_MEAN|4.22||0.0301|TWO_SIDED|95.0|1.13|19.25||P-values are presented for Day 33|Mixed Models Analysis|||||19.25|1.13|0.0301
91656973|NCT02532764|183207320|SUPERIORITY||Difference vs placebo|7.99|STANDARD_ERROR_OF_MEAN|3.91||0.0601|TWO_SIDED|95.0|-0.39|16.37||P-values are presented for Day 33|Mixed Models Analysis|||||16.37|-0.39|0.0601
91616438|NCT00300469|183126189|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.010
91616439|NCT00300469|183126190|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91616440|NCT00300469|183126190|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91616441|NCT01943864|183126263|SUPERIORITY_OR_OTHER||non PD rate at Week 12|10.0||||0.976|TWO_SIDED|95.0|1.2|31.7|||Exact Binomial Test|||||31.7|1.2|0.976
91616442|NCT01943864|183126264|SUPERIORITY_OR_OTHER||non PD rate at Week 12|15.0||||0.909|TWO_SIDED|95.0|3.2|37.9|||Exact Binomial Test|||||37.9|3.2|0.909
91616443|NCT01943864|183126279|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.1|||||Lower and upper limits and estimation value are in terms of weeks|||12.1|4.6|
91616444|NCT01943864|183126280|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.7|||||Lower and upper limits and estimation value are in terms of weeks|||12.7|4.6|
91616445|NCT01943864|183126281|SUPERIORITY_OR_OTHER||Overall Survival|20.0|||||TWO_SIDED|95.0|6.2|39.3||||||||39.3|6.2|
91616446|NCT01943864|183126282|SUPERIORITY_OR_OTHER||ORR|0.0|||||TWO_SIDED|95.0|0.0|16.8||||||||16.8|0|
91616447|NCT01943864|183126283|SUPERIORITY_OR_OTHER||ORR|5.0|||||TWO_SIDED|95.0|0.1|24.9||||||||24.9|0.1|
91616448|NCT00872170|183126288|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||This study had 80% power at level alpha=0.05 to detect a 60 m change in 6MWT among N=10 participants, assuming a 60 m standard deviation for 12-week change.||||0.97
91616449|NCT00872170|183126289|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
91616450|NCT00872170|183126290|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.005
91616451|NCT00872170|183126291|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
91656974|NCT02532764|183207320|SUPERIORITY||Difference vs placebo|3.5|STANDARD_ERROR_OF_MEAN|3.69||0.358|TWO_SIDED|95.0|-4.4|11.41||P-values are presented for Day 33|Mixed Models Analysis|||||11.41|-4.40|0.3580
91656975|NCT02532764|183207320|SUPERIORITY||Difference vs placebo|3.21|STANDARD_ERROR_OF_MEAN|3.89||0.4224|TWO_SIDED|95.0|-5.13|11.55||P-values are presented for Day 33|Mixed Models Analysis|||||11.55|-5.13|0.4224
91712145|NCT03990051|183315833|SUPERIORITY|Comparison of changes in score from baseline, Active - Placebo.||||||0.0197|||||||Mixed Models Analysis|||||||0.0197
91712146|NCT03990051|183315834|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0039|||||||Mixed Models Analysis|||||||0.0039
91712147|NCT03990051|183315835|SUPERIORITY|Comparison of changes in score from baseline.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91712148|NCT03990051|183315836|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0002|||||||ANCOVA|||||||0.0002
91712149|NCT03990051|183315837|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0138|||||||Mixed Models Analysis|||||||0.0138
91712150|NCT03990051|183315838|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
91712151|NCT03990051|183315839|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0849|||||||Mixed Models Analysis|||||||0.0849
91712152|NCT03990051|183315840|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0041|||||||Mixed Models Analysis|||||||0.0041
91712153|NCT03990051|183315841|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0006|||||||Mixed Models Analysis|||||||0.0006
91712154|NCT03990051|183315842|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0143|||||||Mixed Models Analysis|||||||0.0143
91712155|NCT03990051|183315843|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0398|||||||Mixed Models Analysis|||||||0.0398
91712156|NCT03990051|183315844|SUPERIORITY|Comparison of changes in score from baseline.||||||-3.97|||||||Mixed Models Analysis|||||||-3.97
91712157|NCT03990051|183315845|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
91656976|NCT02252562|183207331|EQUIVALENCE|We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||fixed effects univariable analysis|||||1.40|0.82|
91712158|NCT03990051|183315846|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
91712159|NCT03990051|183315847|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
91712160|NCT03990051|183315848|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0636|||||||Mixed Models Analysis|||||||0.0636
91712161|NCT03990051|183315849|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0028|||||||Mixed Models Analysis|||||||0.0028
91712162|NCT03990051|183315850|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
91712163|NCT03990051|183315851|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
91712164|NCT03990051|183315852|SUPERIORITY|Comparison of changes in score from baseline.||||||0.001|||||||Mixed Models Analysis|||||||0.0010
91712165|NCT03990051|183315853|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0155|||||||Mixed Models Analysis|||||||0.0155
91712166|NCT03990051|183315854|SUPERIORITY|Comparison of changes in score from baseline.||||||0.016|||||||Mixed Models Analysis|||||||0.0160
91712167|NCT03990051|183315855|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0117|||||||Mixed Models Analysis|||||||0.0117
91712168|NCT03990051|183315856|SUPERIORITY|Comparison of changes in score from baseline.||||||0.4649|||||||Mixed Models Analysis|||||||0.4649
91712169|NCT03990051|183315857|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
91712170|NCT03990051|183315858|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0225|||||||Mixed Models Analysis|||||||0.0225
91712171|NCT03990051|183315859|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1822|||||||Mixed Models Analysis|||||||0.1822
91712172|NCT03990051|183315860|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0515|||||||Mixed Models Analysis|||||||0.0515
91712173|NCT03990051|183315861|SUPERIORITY|Comparison of changes in score from baseline.||||||0.044|||||||Mixed Models Analysis|||||||0.044
91712174|NCT03990051|183315862|SUPERIORITY|Comparison of changes of score from baseline.||||||0.083|||||||Mixed Models Analysis|||||||0.083
91712175|NCT03990051|183315863|SUPERIORITY|Comparison of changes in score from baseline.||||||0.7147|||||||Mixed Models Analysis|||||||0.7147
91712176|NCT03990051|183315864|SUPERIORITY|Comparison of changes in score from baseline.||||||0.8251|||||||Mixed Models Analysis|||||||0.8251
91712177|NCT03990051|183315865|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0435|||||||Mixed Models Analysis|||||||0.0435
91712178|NCT03990051|183315866|SUPERIORITY|Comparison of changes in score from baseline.||||||0.013|||||||Mixed Models Analysis|||||||0.0130
91712179|NCT03990051|183315867|SUPERIORITY|Comparison of changes in score from baseline.||||||0.3205|||||||Mixed Models Analysis|||||||0.3205
91712180|NCT03990051|183315868|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1401|||||||Mixed Models Analysis|||||||0.1401
91712181|NCT03990051|183315869|SUPERIORITY|Comparison in changes in score from baseline.||||||0.0098|||||||ANCOVA|||||||0.0098
91712182|NCT03990051|183315870|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1032|||||||Mixed Models Analysis|||||||0.1032
91712183|NCT03990051|183315871|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0389|||||||Mixed Models Analysis|||||||0.0389
91712184|NCT03990051|183315872|OTHER||||||<|1e-05|||||||t-test, 2 sided|||Score in 1 year compared to baseline||||<0.00001
91712185|NCT03990051|183315873|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712186|NCT03990051|183315874|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712187|NCT03990051|183315875|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712188|NCT03990051|183315876|OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91712189|NCT03990051|183315877|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91712190|NCT03990051|183315878|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712191|NCT03990051|183315879|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712192|NCT03990051|183315880|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712193|NCT03990051|183315881|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712194|NCT03990051|183315882|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712195|NCT03990051|183315883|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712196|NCT03990051|183315884|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91712197|NCT03990051|183315885|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91656977|NCT04099888|183207365|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
91656978|NCT04099888|183207366|SUPERIORITY||||||||TWO_SIDED|95.0||||||||OS was analyzed using the modified intent-to-treat (mITT) analysis set, which included all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline. Kaplan Meier Curve (KM) analysis of OS was completed for the mITT population, but the number of events was too small to draw any conclusions.|The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
91656979|NCT04099888|183207367|SUPERIORITY|||||||||||||||||BOR is summarized by randomized treatment group using the mITT analysis set.|The BOR is the best response recorded from the start of the treatment until disease progression or until the last evaluable assessment in the absence of progression. If a patient received subsequent anti-cancer therapy prior to progression, then BOR was calculated up to the point of starting the anti-cancer therapy.|||
91656980|NCT04099888|183207368|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The ORR is calculated as the proportion of patients who have at least one visit response with a complete response (CR) or partial response (PR). Objective responses do not require confirmation in a randomized study. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the analysis of ORR. Data obtained up until progression or subsequent therapy, or last evaluable assessment in the absence of progression or subsequent therapy, will be included in the analysis of ORR.|||
91712198|NCT03990051|183315886|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712199|NCT03990051|183315887|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712200|NCT03990051|183315888|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712201|NCT03990051|183315889|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
91712202|NCT01720524|183315890|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.985|TWO_SIDED|95.0|-2.08|2.04|||ANCOVA|||||2.04|-2.08|0.9850
91712203|NCT01720524|183315891|SUPERIORITY||Difference in percentage|7.6||||0.4935|TWO_SIDED|95.0|-14.1|29.3|||Chi-squared|||||29.3|-14.1|0.4935
91712204|NCT01720524|183315892|SUPERIORITY|||||||0.9885|||||||Log Rank|||||||0.9885
91712205|NCT01720524|183315893|SUPERIORITY|||||||0.491|||||||Log Rank|||||||0.4910
91712206|NCT01720524|183315894|SUPERIORITY||Difference in Percentage|3.8||||0.7065|TWO_SIDED|95.0|-15.2|22.9|||Fisher Exact|||Additional Treatment||22.9|-15.2|0.7065
91712207|NCT01720524|183315894|SUPERIORITY||Difference in Percentage|0.3|||>|0.999|TWO_SIDED|95.0|-18.5|18.5|||Fisher Exact|||ECMO||18.5|-18.5|>0.999
91712208|NCT01720524|183315894|SUPERIORITY||Difference in Percentage|6.9||||0.2373|TWO_SIDED|95.0|-5.5|22.8|||Fisher Exact|||Death||22.8|-5.5|0.2373
91712209|NCT01720524|183315895|SUPERIORITY||LS Mean Difference|3.9||||0.4984|TWO_SIDED|95.0|-7.5|15.3|||ANCOVA|||Hour 6||15.3|-7.5|0.4984
91712210|NCT01720524|183315895|SUPERIORITY||LS Mean Difference|4.1||||0.3956|TWO_SIDED|95.0|-5.5|13.7|||ANCOVA|||Hour 12||13.7|-5.5|0.3956
91712211|NCT01720524|183315895|SUPERIORITY||LS Mean Difference|-2.2||||0.4249|TWO_SIDED|95.0|-7.6|3.3|||ANCOVA|||Hour 24||3.3|-7.6|0.4249
91712212|NCT01720524|183315896|SUPERIORITY||LS Mean Difference|0.7||||0.7686|TWO_SIDED|95.0|-4.3|5.8|||ANCOVA|||Hour 6||5.8|-4.3|0.7686
91712213|NCT01720524|183315896|SUPERIORITY||LS Mean Difference|-8.0||||0.1112|TWO_SIDED|95.0|-17.8|1.9|||ANCOVA|||Hour 12||1.9|-17.8|0.1112
91712214|NCT01720524|183315896|SUPERIORITY||LS Mean Difference|-8.2||||0.2089|TWO_SIDED|95.0|-21.2|4.8|||ANCOVA|||Hour 24||4.8|-21.2|0.2089
91712215|NCT01720524|183315897|SUPERIORITY||LS Mean Difference|37.2||||0.0829|TWO_SIDED|95.0|-5.0|79.5|||ANCOVA|||Hour 6||79.5|-5.0|0.0829
91712216|NCT01720524|183315897|SUPERIORITY||LS Mean Difference|26.6||||0.1802|TWO_SIDED|95.0|-12.7|65.9|||ANCOVA|||Hour 12||65.9|-12.7|0.1802
91712217|NCT01720524|183315897|SUPERIORITY||LS Mean Difference|79.9||||0.1576|TWO_SIDED|95.0|-32.5|192.2|||ANCOVA|||Hour 24||192.2|-32.5|0.1576
91712218|NCT00158262|183315931|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-2.7|16.7|||||Placebo-Propranolol|||16.7|-2.7|
91712219|NCT00158262|183315932|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-15.5|15.3|||||Placebo-Propranolol|CAPS Total Score at Month 1||15.3|-15.5|
91712220|NCT00158262|183315932|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-20.3|16.0||||||CAPS Total Score at Month 3||16.0|-20.3|
91712221|NCT00158262|183315933|SUPERIORITY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|-4.8|10.7|||||Placebo-Propranolol|||10.7|-4.8|
91712222|NCT00527826|183315934|NON_INFERIORITY_OR_EQUIVALENCE|Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.73||95.0|||||Negative binomial model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.73
91712223|NCT00527826|183315936|NON_INFERIORITY_OR_EQUIVALENCE|Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.66||95.0|||||Poisson model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.66
91712224|NCT01150903|183315960|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
91712225|NCT01150903|183315961|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
91616452|NCT00872170|183126292|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.05
91616453|NCT00872170|183126293|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
91616454|NCT00872170|183126294|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
91616455|NCT00872170|183126295|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.33
91616456|NCT00872170|183126296|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.18
91616457|NCT00872170|183126297|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.97
91616458|NCT00872170|183126298|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.96
91616459|NCT03302416|183126307|SUPERIORITY|Baseline scan VT vs. Post-hydrocortisone scan VT||||||0.005|||||||Linear mixed model|||||||0.005
91616460|NCT05319535|183126312|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.26|TWO_SIDED|95.0|-1.8|6.1|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||6.1|-1.8|0.26
91656981|NCT04099888|183207369|SUPERIORITY|||||||||||||||||The DoR was calculated only for those with a documented response of CR or PR and is defined as the time from the date of first documented tumor response until the first date of documented disease progression or death, whichever is earlier.|DoR is listed only. In Arm A, the duration of response was 169 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm A, the events were censored at 260 and 264 days, respectively. In Arm B, the duration of response was 85 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm B, the events were censored at 1 day due to the early termination of the study.|||
91616461|NCT05319535|183126313|SUPERIORITY||rate ratio|1.7||||0.11|TWO_SIDED|95.0|0.9|3.4|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||3.4|0.9|0.11
91616462|NCT05319535|183126314|SUPERIORITY||Mean Difference (Final Values)|37.6||||0.17|TWO_SIDED|95.0|-18.1|93.3|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||93.3|-18.1|0.17
91616463|NCT05319535|183126315|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1|TWO_SIDED|95.0|-0.1|1.4|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||1.4|-0.1|0.10
91616464|NCT05319535|183126316|SUPERIORITY||rate ratio|1.3||||0.36|TWO_SIDED|95.0|0.7|2.3|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||2.3|0.7|0.36
91616465|NCT05319535|183126317|SUPERIORITY||Odds Ratio (OR)|3.3||||0.17|TWO_SIDED|95.0|0.6|18.5|||Regression, Logistic|||Model included the arm indicator variable.||18.5|0.6|0.17
91616466|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.0||||0.9946|TWO_SIDED|95.0|0.83|1.2|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/ Placebo\].|Time to first vascular AE (SAF-M1)||1.20|0.83|0.9946
91616467|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.95||||0.7474|TWO_SIDED|95.0|0.72|1.27|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo. \[Treatment/Placebo\].|Time to first vascular AE (SAF-M2)||1.27|0.72|0.7474
91616468|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.03||||0.7943|TWO_SIDED|95.0|0.81|1.31|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment / Placebo\]|Time to first vascular AE (Trial NCT01131676, all empagliflozin (10 and 25 mg vs. Placebo))||1.31|0.81|0.7943
91616469|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.97||||0.8518|TWO_SIDED|95.0|0.69|1.36|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment / Placebo\].|Time to first vascular AE (Trial NCT03057951)||1.36|0.69|0.8518
91616470|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.93||||0.766|TWO_SIDED|95.0|0.56|1.53|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first vascular AE (Trial NCT03057977)||1.53|0.56|0.7660
91616471|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.15||||0.3612|TWO_SIDED|95.0|0.85|1.55|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M1)||1.55|0.85|0.3612
91616472|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.44||||0.161|TWO_SIDED|95.0|0.86|2.4|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M2)||2.40|0.86|0.1610
91616473|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.02||||0.9128|TWO_SIDED|95.0|0.71|1.47|||Regression, Cox|Cox regression for time to first diabetic foot related AE on treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT01131676, all empagliflozin (10 and 25 mg) vs. Placebo)||1.47|0.71|0.9128
91616474|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.81||||0.5276|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT03057951)||1.54|0.43|0.5276
91616475|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|4.72||||0.0048|TWO_SIDED|95.0|1.6|13.87|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment / Placebo\]|Time to first diabetic foot related AE (Trial NCT03057977)||13.87|1.60|0.0048
91616476|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.89||||0.1526|TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox regression of time to first infections potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infections potentially related to LLA's (SAF-M1)||1.04|0.77|0.1526
91616477|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.96||||0.743|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|Cox regression of time to first infection potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infection potentially related to LLA's (SAF-M2)||1.21|0.76|0.7430
91616478|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.85||||0.1049|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|Cox regression for infections potentially related to LLA-on treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs. Placebo)||1.04|0.69|0.1049
91616479|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.89||||0.395|TWO_SIDED|95.0|0.67|1.17|||Regression, Cox|Cox regression for infections potentially related to LLA on treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057951)||1.17|0.67|0.3950
91656982|NCT04099888|183207370|SUPERIORITY||||||||TWO_SIDED|95.0||||||||DCR is reported and includes any patient with a best response of stable disease, PR or CR.|The DCR and associated exact 95% CI is summarized for the mITT population. This was repeated for DCR-6, defined as the proportion of patients with CR, PR or SD at 6 months (recorded at least 24 weeks (+/-1 week) after randomization of study treatment and prior to any PD event).|||
91656983|NCT04099888|183207371|SUPERIORITY|||||||||||||||||Change in tumor size in percentage was summarized for the subset of patients in the mITT analysis set who had measurable disease at baseline.|Tumor size is defined as the sum of the longest diameters (SoDs) of the RECIST 1.1 target lesions. Change in tumor size is defined as the best overall percentage change in tumor size from baseline. Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the SoDs of target lesions compared to baseline.|||
91656984|NCT04099888|183207372|SUPERIORITY||||||||||||||||||Safety, including the incidence and characteristics of biliary/loco-regional tumour-related events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
91616480|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.19||||0.4429|TWO_SIDED|95.0|0.76|1.87|||Regression, Cox|Cox regression for infections potentially related to LLA on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057977)||1.87|0.76|0.4429
91616481|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.89||||0.3396|TWO_SIDED|95.0|0.7|1.13|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M1)||1.13|0.70|0.3396
91656985|NCT04099888|183207373|SUPERIORITY||||||||||||||||||Safety events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
91656986|NCT04099888|183207377|SUPERIORITY||||||||||||||||||As this study was terminated early, a reduced statistical analysis was conducted, and the HRQoL analyses were not conducted.|||
91656987|NCT00023309|183207378|SUPERIORITY_OR_OTHER|||||||0.0294||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in the treatment effect between the two groups||||0.0294
91656988|NCT00023309|183207379|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0325
91616482|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.7||||0.105|TWO_SIDED|95.0|0.46|1.08|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M2)||1.08|0.46|0.1050
91616483|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.0||||0.9919|TWO_SIDED|95.0|0.74|1.35|||Regression, Cox|Cox regression for time to first wound/infection on-treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.35|0.74|0.9919
91656989|NCT00023309|183207380|SUPERIORITY_OR_OTHER|||||||0.0049||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0049
91616484|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.79||||0.3634|TWO_SIDED|95.0|0.48|1.31|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057951)||1.31|0.48|0.3634
91616485|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.52||||0.1177|TWO_SIDED|95.0|0.23|1.18|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057977)||1.18|0.23|0.1177
91616486|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.0||||0.9992|TWO_SIDED|95.0|0.84|1.19|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M1)||1.19|0.84|0.9992
91616487|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.09||||0.6274|TWO_SIDED|95.0|0.78|1.52|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M2)||1.52|0.78|0.6274
91616488|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|0.97||||0.7597|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.19|0.79|0.7597
91616489|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.08||||0.7067|TWO_SIDED|95.0|0.74|1.57|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT03057951)||1.57|0.74|0.7067
91616490|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.12||||0.7404|TWO_SIDED|95.0|0.56|2.25|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|time to first nervous system disorder (Trial NCT03057977)||2.25|0.56|0.7404
91616491|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.21||||0.1765|TWO_SIDED|95.0|0.92|1.58|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M1)||1.58|0.92|0.1765
91616492|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.22||||0.1978|TWO_SIDED|95.0|0.9|1.66|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M2)||1.66|0.90|0.1978
91656990|NCT00023309|183207381|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0157
91656991|NCT00023309|183207382|SUPERIORITY_OR_OTHER|||||||0.0913||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0913
91656992|NCT01050647|183207386|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
91656993|NCT01050647|183207387|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
91656994|NCT01050647|183207388|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
91712226|NCT04501952|183315968|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
91616493|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.14||||0.6561|TWO_SIDED|95.0|0.64|2.05|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||2.05|0.64|0.6561
91616494|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.29||||0.1699|TWO_SIDED|95.0|0.9|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057951)||1.87|0.90|0.1699
91616495|NCT04937816|183126334|OTHER||Hazard Ratio (HR)|1.08||||0.7944|TWO_SIDED|95.0|0.62|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057977)||1.87|0.62|0.7944
91656995|NCT01050647|183207389|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91656996|NCT01050647|183207390|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91616496|NCT04937816|183126335|OTHER||Hazard Ratio (HR)|1.02||||0.9276|TWO_SIDED|95.0|0.73|1.42|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|||1.42|0.73|0.9276
91616497|NCT04937816|183126335|OTHER||Hazard Ratio (HR)|0.85||||0.6205|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\]|||1.60|0.45|0.6205
91616498|NCT04937816|183126335|OTHER||Hazard Ratio (HR)|1.09||||0.6768|TWO_SIDED|95.0|0.73|1.63|||Regression, Cox|Cox regression model with terms for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Empagliflozin (10 mg + 25 mg) versus Placebo.||1.63|0.73|0.6768
91616499|NCT04937816|183126335|OTHER||Hazard Ratio (HR)|0.73||||0.4294|TWO_SIDED|95.0|0.34|1.59|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||1.59|0.34|0.4294
91656997|NCT04276883|183207393|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91656998|NCT04276883|183207393|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91656999|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
91657000|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
91657001|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
91657002|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
91657003|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
91657004|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
91657005|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
91657006|NCT04276883|183207394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
91657007|NCT04276883|183207394|SUPERIORITY|||||||0.0006|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||0.0006
91657008|NCT04276883|183207394|SUPERIORITY|||||||0.0028|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0028
91616500|NCT04937816|183126335|OTHER||Hazard Ratio (HR)|1.17||||0.7826|TWO_SIDED|95.0|0.39|3.47|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||3.47|0.39|0.7826
91616501|NCT05513053|183126339|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.98|||||TWO_SIDED|95.0|1.73|2.27||||||Statistical analysis for A/H1N1||2.27|1.73|
91616502|NCT05513053|183126339|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|3.27|||||TWO_SIDED|95.0|2.76|3.87||||||Statistical analysis for A/H3N2||3.87|2.76|
91616503|NCT05513053|183126339|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.35|1.82||||||Statistical analysis for B/Victoria||1.82|1.35|
91616504|NCT05513053|183126339|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.22|||||TWO_SIDED|95.0|1.09|1.37||||||Statistical analysis for B/Yamagata||1.37|1.09|
91616505|NCT05513053|183126340|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|1.92|||||TWO_SIDED|95.0|-2.78|6.62||||||Statistical analysis for A/H1N1||6.62|-2.78|
91616506|NCT05513053|183126340|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|-0.59|||||TWO_SIDED|95.0|-4.41|3.23||||||Statistical analysis for A/H3N2||3.23|-4.41|
91616507|NCT05513053|183126340|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|3.29|||||TWO_SIDED|95.0|-1.57|8.14||||||Statistical analysis for B/Victoria||8.14|-1.57|
91657009|NCT04276883|183207394|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0070
91616508|NCT05513053|183126340|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|14.3|||||TWO_SIDED|95.0|9.17|19.3||||||Statistical analysis for B/Yamagata||19.3|9.17|
91616509|NCT02429258|183126362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.0|STANDARD_ERROR_OF_MEAN|6.08|<|0.001||95.0|-36.1|-12.0|||Mixed Models Analysis|||||-12.0|-36.1|<0.001
91616510|NCT02429258|183126363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.8||0.01||95.0|-26.8|-3.8|||ANCOVA|||||-3.8|-26.8|0.010
91616511|NCT02429258|183126364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.42||0.023||95.0|0.1|1.8|||ANCOVA|||||1.8|0.1|0.023
91616512|NCT02429258|183126365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.001||95.0|7.7|22.2|||ANCOVA|||||22.2|7.7|<0.001
91616513|NCT02429258|183126366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.72|<|0.001||95.0|-23.5|-8.7|||ANCOVA|||||-8.7|-23.5|<0.001
91657010|NCT04276883|183207394|SUPERIORITY|||||||0.0092|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.0092
91657011|NCT02458469|183207403|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
91616514|NCT02429258|183126367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7|STANDARD_ERROR_OF_MEAN|8.47|<|0.001||95.0|-46.6|-12.9|||ANCOVA|||||-12.9|-46.6|<0.001
91616515|NCT02429258|183126368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|9.14|<|0.001||95.0|-59.0|-22.7|||ANCOVA|||||-22.7|-59.0|<0.001
91616516|NCT02429258|183126369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.024||95.0|-0.43|-0.03|||ANCOVA|||||-0.03|-0.43|0.024
91616517|NCT02429258|183126370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.55||0.019||95.0|-19.9|-1.8|||ANCOVA|||||-1.8|-19.9|0.019
91657012|NCT02458469|183207403|SUPERIORITY|||||||0.015|||||||Student-Newman-Keuls Method|||||||0.015
91616518|NCT02429258|183126371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.3|STANDARD_ERROR_OF_MEAN|9.25|<|0.001||95.0|-54.7|-17.9|||ANCOVA|||||-17.9|-54.7|<0.001
91616519|NCT02429258|183126372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.86||0.017||95.0|1.3|12.7|||ANCOVA|||||12.7|1.3|0.017
91616520|NCT01520324|183126373|OTHER|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.||||||||||||||||The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with intraepithelial neoplasiae was presented|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.|||
91616521|NCT00495495|183126399|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.1126|ONE_SIDED||||||McNemar|||"Null hypothesis: there is no difference between the HealOzone and Placebo devices in the proportion of teeth with lesion progression after 1 year.~Power calculation: the study was sized to have 90% power to detect a 15% difference between treatments in the percentage of teeth with lesion progression at one year (i.e., assuming 45% for the lesions treated with the Placebo device and 30% for the lesions treated with the HealOzone device) with a sample size of 258 subjects completing the study."||||0.1126
91616522|NCT00495495|183126400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.08||||0.9777|ONE_SIDED||||||McNemar|||||||.9777
91616523|NCT00495495|183126401|SUPERIORITY_OR_OTHER|||||||0.0416|ONE_SIDED|95.0|||||McNemar|||||||.0416
91616524|NCT00495495|183126402|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.6585|ONE_SIDED|95.0|||||McNemar|||||||0.6585
91616525|NCT00495495|183126403|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.7666|ONE_SIDED|95.0|||||McNemar|||||||.7666
91657013|NCT02458469|183207403|SUPERIORITY|||||||0.231|||||||Student-Newman-Keuls Method|||||||0.231
91657014|NCT02458469|183207404|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
91657015|NCT01430741|183207406|SUPERIORITY_OR_OTHER||||||=|0.04|||||||Mixed Models Analysis|||Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.04
91616526|NCT04009096|183126406|OTHER|||||||0.14||||||Two tailed p value reported for Mann-Whitney test comparing controls with each vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of pooled data from Groups 1, 2 and 3 volunteers who completed CHMI with pooled data of infectivity controls (unvaccinated) from CHMI study running in parallel (VAC069 study)||||0.14
91616527|NCT04263142|183126411|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.9263|1.0757|||||Analysis was performed using analysis of variance (ANOVA) with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0757|0.9263|
91616528|NCT04263142|183126412|OTHER||Ratio|1.002|||||TWO_SIDED|90.0|0.9321|1.0781|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0781|0.9321|
91616529|NCT04263142|183126413|OTHER||Ratio|1.093|||||TWO_SIDED|90.0|0.9885|1.208|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablets/capsules.|||1.2080|0.9885|
91616530|NCT04263142|183126415|OTHER||Ratio|2.926|||||TWO_SIDED|90.0|2.3703|3.6107|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.6107|2.3703|
91616531|NCT04263142|183126415|OTHER||Ratio|2.594|||||TWO_SIDED|90.0|2.1003|3.2038|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.2038|2.1003|
91616532|NCT04263142|183126416|OTHER||Ratio|3.146|||||TWO_SIDED|90.0|2.5925|3.8178|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.8178|2.5925|
91657016|NCT01430741|183207407|SUPERIORITY_OR_OTHER||||||=|0.21|||||||Mixed Models Analysis|||Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.21
91657017|NCT01430741|183207407|SUPERIORITY_OR_OTHER||||||=|0.07|||||||Mixed Models Analysis|||Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.07
91657018|NCT01430741|183207408|SUPERIORITY_OR_OTHER||||||=|0.14|||||||Mixed Models Analysis|||Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.14
91657019|NCT01430741|183207408|SUPERIORITY_OR_OTHER||||||=|0.19|||||||Mixed Models Analysis|||Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.19
91657020|NCT01430741|183207409|SUPERIORITY_OR_OTHER||||||=|0.24|||||||Mixed Models Analysis|||Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.24
91657021|NCT01430741|183207410|SUPERIORITY_OR_OTHER||||||=|0.481|||||||Regression, Cox|||We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.||||=.481
91657022|NCT03587207|183207449|OTHER|rMenBOMV+ACWY\_S is to be declared statistically inferior if the 2-sided 80% CIs of the between group ratio of the GMT with rMenBOMV+ACWY\_D as control is lower than 1 at 1 month after last vaccination. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|0.96|||||TWO_SIDED|80.0|0.83|1.1|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after last vaccination.||1.10|0.83|
91657023|NCT03587207|183207450|OTHER|M14459 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.84|1.2|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.20|0.84|
91657024|NCT03587207|183207450|OTHER|96217 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.05||||||80.0|0.88|1.26|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.26|0.88|
91657025|NCT03587207|183207450|OTHER|NZ98/254 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.95|0.64|
91616533|NCT04263142|183126416|OTHER||Ratio|2.785|||||TWO_SIDED|90.0|2.2943|3.3807|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.3807|2.2943|
91657026|NCT03587207|183207450|OTHER|M07-0241084 strain- Between group ratios for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.66|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.96|0.66|
91712227|NCT04501952|183315970|SUPERIORITY||Hazard Ratio (HR)|0.191||||0.0024|TWO_SIDED|95.0|0.065|0.555|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.555|0.065|0.0024
91712228|NCT04501952|183315973|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
91712229|NCT04501952|183315974|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0019|TWO_SIDED|95.0|0.023|0.43|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.430|0.023|0.0019
91712230|NCT04501952|183315975|SUPERIORITY||Least Squares Mean|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4318|TWO_SIDED|95.0|-0.1|0.24|||ANCOVA|P-value were from an ANCOVA model with baseline viral load as a covariate.|Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.|||0.24|-0.10|0.4318
91712231|NCT04501952|183315976|SUPERIORITY||Hazard Ratio (HR)|1.405||||0.2987|TWO_SIDED|95.0|0.733|2.693|||Log Rank|p-value was based on stratified log-rank test with baseline stratification factor as strata.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||2.693|0.733|0.2987
91712232|NCT04501952|183315978|SUPERIORITY|||||||0.2163|||||||Fisher Exact|||||||0.2163
91712233|NCT00086450|183315982|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.9||||0.005||95.0|3.3|12.5|||Regression, Cox|||||12.5|3.3|0.005
91712234|NCT00086450|183315983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.74||||0.004||95.0|1.91|3.89|||Regression, Cox|||||3.89|1.91|0.004
91712235|NCT00086450|183315984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.049||95.0|||||Log Rank|||||||0.049
91712236|NCT00086450|183315985|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Regression, Cox|||||||0.68
91712237|NCT04550364|183315989|OTHER|Semi-structured interview, background information, DSM 5 diagnosis and ED symptoms.||||||||||||||||23 of 24 women were used ideal type analysis as the methods. EDE-Q and DSM 5 diagnosis were measured.|Ideal type analysis as main method of analysis|||
91712238|NCT04550364|183315990|OTHER|Interpretative phenomenological analysis (IPA)||||||||||||||||of the 24 mothers there were 7 of them that had undergone In vitro fertilization. These women were interviewed twice and IPA were used in analysis the material.|IPA|||
91712239|NCT04550364|183315991|OTHER|Grounded theory was used analysis method. 5 distinct ED trajectories into motherhood were identified based on the womens experiences from pregnancy to postpartum.||||||||||||||||This study was based on interviews conducted with 24 participants during pregnancy and postpartum. Semi-structured interview with 24 women at two time points: 1. During pregnancy and 2. 4-6 months after birth. DSM 5 diagnosis at both time points were also assessed and symptoms at eating disorders through EDE-Q.|Qualitative methods using Ground theory|||
91712240|NCT03138577|183316021|OTHER||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
91712241|NCT03138577|183316022|OTHER|||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
91712242|NCT03138577|183316023|OTHER||Median Difference (Final Values)|7.5||||0.01|TWO_SIDED||||||Sign test|||||||0.01
91616534|NCT04263142|183126417|OTHER||Ratio|4.101|||||TWO_SIDED|90.0|3.2442|5.183|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||5.1830|3.2442|
91616535|NCT04263142|183126417|OTHER||Ratio|3.08|||||TWO_SIDED|90.0|2.4359|3.8935|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.8935|2.4359|
91712243|NCT03138577|183316023|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
91712244|NCT03138577|183316024|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
91712245|NCT03138577|183316025|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
91712246|NCT03138577|183316026|OTHER||Median Difference (Final Values)|-1.0||||0.01|TWO_SIDED||||||Sign test|||||||0.01
91712247|NCT03138577|183316026|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
91712248|NCT03138577|183316027|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91712249|NCT02716584|183316044|SUPERIORITY||Effect size|0.41||||0.02|TWO_SIDED||||||ANCOVA|||Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of exercise sessions attended as a covariate.||||0.02
91712250|NCT02716584|183316045|SUPERIORITY||Effect size|0.35||||0.06|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.06
91712251|NCT02716584|183316046|SUPERIORITY|||||||0.13|||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.13
91616536|NCT03439748|183126520|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.002
91616537|NCT03439748|183126521|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||>.05
91616538|NCT03439748|183126522|SUPERIORITY|||||||0.024||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.024
91616539|NCT03439748|183126526|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.922
91616540|NCT03439748|183126527|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.049
91616541|NCT03439748|183126528|SUPERIORITY|||||||0.591||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.591
91616542|NCT03439748|183126529|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.004
91616543|NCT03439748|183126530|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.030
91616544|NCT03439748|183126531|SUPERIORITY|||||||0.029||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.029
91616545|NCT03439748|183126533|SUPERIORITY|||||||0.494||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.494
91657027|NCT03587207|183207450|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.92|||||TWO_SIDED|80.0|0.74|1.14|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after last vaccination.||1.14|0.74|
91791356|NCT03720652|183460432|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.090
91616546|NCT03439748|183126534|SUPERIORITY|||||||0.231||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.231
91616547|NCT03439748|183126535|SUPERIORITY|||||||0.344||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.344
91616548|NCT03439748|183126536|SUPERIORITY|||||||0.267||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.267
91616549|NCT03439748|183126537|SUPERIORITY|||||||0.051||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.051
91616550|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with atorvastatin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.30
91616551|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with sulindac compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.60
91616552|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with oligofructose-enriched inulin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.92
91616553|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.59
91616554|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.12
91616555|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.54
91616556|NCT00335504|183126542|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.41
91524279|NCT04858802|182923764|SUPERIORITY||Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|12.64||0.063|TWO_SIDED|95.0|-5.7|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.2|-5.7|0.063
91616557|NCT00335504|183126543|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between atorvastatin and placebo.||||0.37
91524280|NCT04858802|182923765|SUPERIORITY||Mean Difference (Final Values)|50.94|STANDARD_DEVIATION|430.8||0.306|TWO_SIDED|95.0|-47.5|149.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||149.4|-47.5|0.306
91616558|NCT00335504|183126543|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between sulindac and placebo.||||1.00
91616559|NCT00335504|183126543|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between oligofructose-enriched inulin and placebo.||||0.58
91616560|NCT00335504|183126544|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between atorvastatin calcium and placebo.||||0.26
91616561|NCT00335504|183126544|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between sulindac and placebo.||||0.88
91616562|NCT00335504|183126544|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between oligofructose-enriched inulin and placebo.||||0.38
91616563|NCT01856595|183126586|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|8.532||0.7457|TWO_SIDED|90.0|-16.93|11.38||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||11.38|-16.93|0.7457
91616564|NCT01856595|183126586|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|8.334||0.0108|TWO_SIDED|90.0|-35.47|-7.81||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-7.81|-35.47|0.0108
91616565|NCT01856595|183126586|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-26.59|STANDARD_ERROR_OF_MEAN|8.309||0.0018|TWO_SIDED|90.0|-40.38|-12.8||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-12.80|-40.38|0.0018
91616566|NCT01856595|183126586|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-32.33|STANDARD_ERROR_OF_MEAN|8.038||0.0001|TWO_SIDED|90.0|-45.66|-18.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-18.99|-45.66|0.0001
91524281|NCT04858802|182923765|SUPERIORITY||Mean Difference (Final Values)|-27.44|STANDARD_DEVIATION|413.22||0.567|TWO_SIDED|95.0|-122.5|67.6|||t-test, 2 sided|Paired; the threshold for statistical significance was p = 0.05.|Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||67.6|-122.5|0.567
91524282|NCT04858802|182923766|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|1.92||0.031|TWO_SIDED|95.0|0.0|0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||0.9|0.0|0.031
91524283|NCT04858802|182923766|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.27||0.943|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.5|0.943
91524284|NCT04858802|182923767|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|1.24||0.715|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 45||0.2|-0.3|0.715
91712252|NCT02716584|183316047|SUPERIORITY||Effect size|0.19||||0.73|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.73
91616567|NCT01856595|183126586|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-42.39|STANDARD_ERROR_OF_MEAN|8.34|<|0.0001|TWO_SIDED|90.0|-56.23|-28.55||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-28.55|-56.23|<0.0001
91616568|NCT01856595|183126587|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|10.47|STANDARD_ERROR_OF_MEAN|9.621||0.279|TWO_SIDED|90.0|-5.5|26.43||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||26.43|-5.50|0.2790
91616569|NCT01856595|183126587|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-19.33|STANDARD_ERROR_OF_MEAN|8.777||0.0299||90.0|-33.89|-4.76||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-4.76|-33.89|0.0299
91616570|NCT01856595|183126588|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-29.43|STANDARD_ERROR_OF_MEAN|7.609||0.0005|TWO_SIDED|90.0|-42.28|-16.57||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-16.57|-42.28|0.0005
91616571|NCT01856595|183126588|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-11.89|STANDARD_ERROR_OF_MEAN|7.321||0.1133|TWO_SIDED|90.0|-24.26|0.48||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.48|-24.26|0.1133
91712253|NCT02716584|183316047|SUPERIORITY||Effect size|0.73||||0.33|TWO_SIDED|||||For cohort 3, positive affect was measured at baseline and a midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.33
91712254|NCT02716584|183316048|SUPERIORITY||Effect size|-0.21||||0.62|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.62
91712255|NCT02716584|183316048|SUPERIORITY||Effect size|0.77||||0.23|TWO_SIDED|||||For cohort 3, positive affect was measured at a baseline and midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.23
91712256|NCT02716584|183316049|SUPERIORITY||Effect size|0.02||||0.57|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.57
91712257|NCT02716584|183316050|SUPERIORITY||Effect size|0.35||||0.12|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.12
91712258|NCT02716584|183316051|SUPERIORITY||Effect size|0.72||||0.07|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.07
91616572|NCT01856595|183126589|SUPERIORITY_OR_OTHER||Ratio|0.99|STANDARD_ERROR_OF_MEAN|1.066||0.853|TWO_SIDED|90.0|0.89|1.1||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.89|0.8530
91616573|NCT01856595|183126589|SUPERIORITY_OR_OTHER||Ratio|0.86|STANDARD_ERROR_OF_MEAN|1.065||0.0172|TWO_SIDED|90.0|0.77|0.95||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.95|0.77|0.0172
91712259|NCT02716584|183316052|SUPERIORITY||Effect size|0.0||||0.88|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.88
91712260|NCT02716584|183316053|SUPERIORITY||Effect size|0.05||||0.86|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.86
91712261|NCT02497937|183316054|OTHER||Mean Difference (Net)|0.793|||||TWO_SIDED|95.0|-0.925|2.512|||||Difference estimate of DLco on Day 7 has been presented for Mayo site|||2.512|-0.925|
91616574|NCT01856595|183126589|SUPERIORITY_OR_OTHER||Ratio|0.85|STANDARD_ERROR_OF_MEAN|1.064||0.0106|TWO_SIDED|90.0|0.77|0.94||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.94|0.77|0.0106
91616575|NCT01856595|183126589|SUPERIORITY_OR_OTHER||Ratio|0.82|STANDARD_ERROR_OF_MEAN|1.062||0.0012|TWO_SIDED|90.0|0.74|0.9||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.90|0.74|0.0012
91616576|NCT01856595|183126589|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.065|<|0.0001|TWO_SIDED|90.0|0.69|0.85||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.85|0.69|<0.0001
91616577|NCT01856595|183126590|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.075||0.7804|TWO_SIDED|90.0|0.87|1.1||Two-sided p-values are from analysis of ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.87|0.7804
91657028|NCT03587207|183207450|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.78|1.27|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after last vaccination.||1.27|0.78|
91657029|NCT03587207|183207450|OTHER|Serogroup W- Between group ratios for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.97|||||TWO_SIDED|80.0|0.79|1.18|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after last vaccination.||1.18|0.79|
91657030|NCT03587207|183207450|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.69|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.19|0.69|
91657031|NCT03587207|183207450|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.86|
91657032|NCT03587207|183207450|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.66|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.||0.95|0.66|
91657033|NCT03587207|183207450|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.65|0.97|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.97|0.65|
91657034|NCT03587207|183207450|NON_INFERIORITY|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.6|0.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.88|0.60|
91657035|NCT03587207|183207450|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.56|||||TWO_SIDED|80.0|0.45|0.69|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.||0.69|0.45|
91657036|NCT03587207|183207450|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.19|||||TWO_SIDED|80.0|0.94|1.52|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after last vaccination.||1.52|0.94|
91657037|NCT03587207|183207450|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.06|||||TWO_SIDED|80.0|0.87|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after last vaccination.||1.29|0.87|
91657038|NCT03587207|183207450|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.18|||||TWO_SIDED|80.0|0.9|1.55|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.55|0.90|
91657039|NCT03587207|183207450|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.||1.22|0.85|
91657040|NCT03587207|183207450|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.9|||||TWO_SIDED|80.0|0.75|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.09|0.75|
91524285|NCT04858802|182923767|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.96||0.129|TWO_SIDED|95.0|0.0|0.4|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 180||0.4|0.0|0.129
91524286|NCT04858802|182923768|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.28|3.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 21||3.60|0.28|1.00
91524287|NCT04858802|182923768|SUPERIORITY||Odds Ratio (OR)|0.79||||0.453|TWO_SIDED|95.0|0.36|1.73||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45||1.73|0.36|0.453
91524288|NCT04858802|182923768|SUPERIORITY||Odds Ratio (OR)|0.71||||0.219|TWO_SIDED|95.0|0.31|1.61||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 90||1.61|0.31|0.219
91524289|NCT04858802|182923768|SUPERIORITY||Odds Ratio (OR)|0.71||||0.289|TWO_SIDED|95.0|0.31|1.61|||t-test, 2 sided|||Day 180||1.61|0.31|0.289
91524290|NCT04858802|182923769|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|21.12||0.971|TWO_SIDED|95.0|-4.9|4.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|Day 180||4.8|-4.9|0.971
91524291|NCT04858802|182923770|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.56||1|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45|Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|0.1|-0.1|1.00
91524292|NCT04858802|182923770|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.42||0.288|TWO_SIDED|95.0|0.0|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|0.0|0.288
91524293|NCT04858802|182923771|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.64||0.225|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|Day 45||0.1|-0.2|0.225
91524294|NCT04858802|182923771|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.65||0.388|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone modified Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|-0.2|0.388
91524295|NCT04858802|182923772|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.68||0.537|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 21||0.1|-0.2|0.537
91524296|NCT04858802|182923772|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_DEVIATION|0.54||0.01|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 45||0.0|-0.3|0.010
91524297|NCT04858802|182923772|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.7||0.003|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.003
91524298|NCT04858802|182923772|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.66||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 180||-0.1|-0.4|0.007
91524299|NCT04858802|182923773|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_DEVIATION|35.55||0.634|TWO_SIDED|95.0|-12.8|7.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 21||7.9|-12.8|0.634
91524300|NCT04858802|182923773|SUPERIORITY||Mean Difference (Final Values)|-7.63|STANDARD_DEVIATION|29.04||0.048|TWO_SIDED|95.0|-15.2|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 45||-0.1|-15.2|0.048
91616578|NCT01856595|183126590|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.068||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
91616579|NCT01856595|183126591|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.083||0.0027|TWO_SIDED|90.0|0.68|0.88||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.88|0.68|0.0027
91524301|NCT04858802|182923773|SUPERIORITY||Mean Difference (Final Values)|-7.78|STANDARD_DEVIATION|28.79||0.028|TWO_SIDED|95.0|-14.7|-0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 90||-0.9|-14.7|0.028
91616580|NCT01856595|183126591|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.079||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
91616581|NCT01856595|183126595|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.123||0.8723|TWO_SIDED|90.0|0.81|1.19||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.19|0.81|0.8723
91524302|NCT04858802|182923773|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|27.99||0.041|TWO_SIDED|95.0|-13.2|-0.3||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 180||-0.3|-13.2|0.041
91616582|NCT01856595|183126595|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.124||0.5158|TWO_SIDED|90.0|0.76|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.76|0.5158
91712262|NCT03538691|183316108|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.51|TWO_SIDED|95.0|0.776|1.669|||Log Rank||The hazard ratio and 95% confidence interval (CI) were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.669|0.776|0.5100
91712263|NCT03538691|183316109|SUPERIORITY||Least Squares (LS) Mean Difference|0.23||||0.2393|TWO_SIDED|95.0|-0.16|0.62||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||||0.62|-0.16|0.2393
91712264|NCT03538691|183316110|SUPERIORITY||Hazard Ratio (HR)|1.177||||0.3086|TWO_SIDED|95.0|0.857|1.615|||Log Rank||The hazard ratio and 95% CI were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.615|0.857|0.3086
91712265|NCT03538691|183316111|SUPERIORITY|||||||0.603|||||||Chi-squared|||||||0.6030
91712266|NCT03538691|183316112|SUPERIORITY|||||||0.7081|||||||Chi-squared|||Week 21||||0.7081
91712267|NCT03538691|183316112|SUPERIORITY|||||||0.4589|||||||Chi-squared|||Week 23||||0.4589
91712268|NCT03538691|183316112|SUPERIORITY|||||||0.5314|||||||Chi-squared|||Week 25||||0.5314
91712269|NCT03538691|183316112|SUPERIORITY|||||||0.1433|||||||Chi-squared|||Week 29||||0.1433
91712270|NCT03538691|183316112|SUPERIORITY|||||||0.9636|||||||Chi-squared|||Week 33||||0.9636
91712271|NCT03538691|183316112|SUPERIORITY|||||||0.7596|||||||Chi-squared|||Week 37||||0.7596
91524303|NCT04858802|182923774|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.96||0.063|TWO_SIDED|95.0|-0.5|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 21||0.0|-0.5|0.063
91712272|NCT03538691|183316112|SUPERIORITY|||||||0.2402|||||||Chi-squared|||Week 41||||0.2402
91616583|NCT01856595|183126595|SUPERIORITY_OR_OTHER||Ratio|0.83|STANDARD_ERROR_OF_MEAN|1.126||0.1258|TWO_SIDED|90.0|0.68|1.01||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.01|0.68|0.1258
91712273|NCT03538691|183316112|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Week 45||||0.8363
91712274|NCT03538691|183316112|SUPERIORITY|||||||0.8308|||||||Chi-squared|||Week 46||||0.8308
91712275|NCT03538691|183316113|SUPERIORITY||LS Mean Difference|-0.12||||0.8806|TWO_SIDED|95.0|-1.73|1.49|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||1.49|-1.73|0.8806
91712276|NCT03538691|183316114|SUPERIORITY||LS Mean Difference|0.03||||0.7956|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||0.24|-0.18|0.7956
91712277|NCT03538691|183316115|SUPERIORITY||LS Mean Difference|0.15||||0.5223|TWO_SIDED|95.0|-0.31|0.61||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Work/School||0.61|-0.31|0.5223
91712278|NCT03538691|183316115|SUPERIORITY||LS Mean Difference|0.36||||0.0904|TWO_SIDED|95.0|-0.06|0.77||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Social Life||0.77|-0.06|0.0904
91712279|NCT03538691|183316115|SUPERIORITY||LS Mean Difference|0.25||||0.2289|TWO_SIDED|95.0|-0.16|0.67||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Family Life||0.67|-0.16|0.2289
91712280|NCT00636636|183316132|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0125|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||||-0.11|-0.88|0.0125
91712281|NCT00636636|183316133|SUPERIORITY_OR_OTHER||Difference in proportion|0.092||||0.0434|TWO_SIDED|95.0|0.0|0.18|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in PGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.18|-0.00|0.0434
91712282|NCT00636636|183316134|SUPERIORITY_OR_OTHER||Difference in proportion|0.102||||0.0268|TWO_SIDED|95.0|0.01|0.19|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in CGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.19|0.01|0.0268
91712283|NCT00636636|183316135|SUPERIORITY_OR_OTHER||Least square mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.18||0.0001|TWO_SIDED|95.0|-1.07|-0.35|||ANCOVA||P-value versus Placebo for pairwise test of difference of LS mean change from baseline between G-ER and Placebo groups is based on t-test of Type III analysis.|||-0.35|-1.07|0.0001
91712284|NCT00636636|183316136|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.96|-0.15|||ANCOVA|||||-0.15|-0.96|0.007
91791357|NCT03720652|183460433|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.051|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.051
91616584|NCT01856595|183126595|SUPERIORITY_OR_OTHER||Ratio|0.89|STANDARD_ERROR_OF_MEAN|1.115||0.2883|TWO_SIDED|90.0|0.74|1.07||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.07|0.74|0.2883
91657041|NCT03587207|183207450|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.96|0.64|
91657042|NCT03587207|183207450|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.58|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.86|0.58|
91527706|NCT01976364|182930497|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.9|-0.3|
91616585|NCT01856595|183126595|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.8437|TWO_SIDED|90.0|0.81|1.18||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.18|0.81|0.8437
91657043|NCT03587207|183207450|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.6|||||TWO_SIDED|80.0|2.9|4.47|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.47|2.90|
91657044|NCT03587207|183207450|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|4.18|||||TWO_SIDED|80.0|3.28|5.31|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.31|3.28|
91657045|NCT03587207|183207450|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.07|||||TWO_SIDED|80.0|2.52|3.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.73|2.52|
91657046|NCT03587207|183207450|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|2.01|||||TWO_SIDED|80.0|1.53|2.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.65|1.53|
91657047|NCT03587207|183207450|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.85|
91657048|NCT03587207|183207450|OTHER|96217 strain- Between group ratios for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.71|1.04|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.04|0.71|
91657049|NCT03587207|183207450|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.82|1.24|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||1.24|0.82|
91657050|NCT03587207|183207450|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|0.89|||||TWO_SIDED|80.0|0.73|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||1.09|0.73|
91657051|NCT03587207|183207450|OTHER|Serogroup A-Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.92|||||TWO_SIDED|80.0|3.15|4.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.88|3.15|
91657052|NCT03587207|183207450|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|4.19|||||TWO_SIDED|80.0|3.3|5.34|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.34|3.30|
91657053|NCT03587207|183207450|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.17|||||TWO_SIDED|80.0|2.6|3.87|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.87|2.60|
91791358|NCT03720652|183460433|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.044|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.044
91616586|NCT01856595|183126596|SUPERIORITY_OR_OTHER||Ratio|1.12|STANDARD_ERROR_OF_MEAN|1.154||0.4405|TWO_SIDED|90.0|0.88|1.42||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.42|0.88|0.4405
91791359|NCT03720652|183460433|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||1|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||1.00
91616587|NCT01856595|183126596|SUPERIORITY_OR_OTHER||Ratio|1.09|STANDARD_ERROR_OF_MEAN|1.146||0.5178|TWO_SIDED|90.0|0.87|1.37||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.37|0.87|0.5178
91616588|NCT01856595|183126597|SUPERIORITY_OR_OTHER||Ratio|0.69|STANDARD_ERROR_OF_MEAN|1.181||0.034|TWO_SIDED|90.0|0.52|0.92||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.92|0.52|0.0340
91616589|NCT01856595|183126597|SUPERIORITY_OR_OTHER||Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.173||0.2519|TWO_SIDED|90.0|0.92|1.58||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.58|0.92|0.2519
91616590|NCT01856595|183126598|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|1.079||0.4579|TWO_SIDED|90.0|0.93|1.2||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.20|0.93|0.4579
91524304|NCT04858802|182923774|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.77||0.015|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 45||-0.1|-0.4|0.015
91616591|NCT01856595|183126598|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.079||0.8144|TWO_SIDED|90.0|0.87|1.11||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.11|0.87|0.8144
91616592|NCT01856595|183126598|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.082||0.3425|TWO_SIDED|90.0|0.81|1.06||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.06|0.81|0.3425
91616593|NCT01856595|183126598|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.076||0.967|TWO_SIDED|90.0|0.88|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.88|0.9670
91616594|NCT01856595|183126598|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.079||0.319|TWO_SIDED|90.0|0.95|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.95|0.3190
91616595|NCT01856595|183126599|SUPERIORITY_OR_OTHER||Ratio|1.14|STANDARD_ERROR_OF_MEAN|1.095||0.1617|TWO_SIDED|90.0|0.98|1.32||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.32|0.98|0.1617
91616596|NCT01856595|183126599|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.084||0.3703|TWO_SIDED|90.0|0.94|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.94|0.3703
91616597|NCT01856595|183126600|SUPERIORITY_OR_OTHER||Ratio|0.95|STANDARD_ERROR_OF_MEAN|1.119||0.6833|TWO_SIDED|90.0|0.79|1.15||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.15|0.79|0.6833
91616598|NCT01856595|183126600|SUPERIORITY_OR_OTHER||Ratio|1.18|STANDARD_ERROR_OF_MEAN|1.112||0.1318|TWO_SIDED|90.0|0.98|1.41||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.41|0.98|0.1318
91657054|NCT03587207|183207450|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|2.22|||||TWO_SIDED|80.0|1.68|2.92|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.92|1.68|
91657055|NCT03587207|183207450|OTHER|M14459- Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.87|1.25|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.25|0.87|
91791360|NCT03720652|183460434|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.023
91616599|NCT00458406|183126636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0|||||t-test, 2 sided|||"We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~Description of power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% confidence interval (CI) for the difference between the 2 means had a range of 1.282 standard deviation (SD)."||||0.512
91616600|NCT00458406|183126637|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
91616601|NCT00458406|183126638|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
91616602|NCT00458406|183126639|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||"Chi-Square test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
91616603|NCT00458406|183126640|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||||>0.05
91616604|NCT00458406|183126640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||<0.05
91712285|NCT01972464|183316163|SUPERIORITY||Odds Ratio (OR)|1.77||||0.39|TWO_SIDED|95.0|0.48|6.52||a priori threshold for statistical significance = 0.05|Regression, Logistic|adjusted for age (18-25 years versus \>25 years) and pre-quit smoking level (\<10 versus \>10 cigarettes per day)|OR represents of odds of abstinence in progesterone group versus placebo group|Null hypothesis- odds of week 8 point prevalence abstinence were equal between placebo and progesterone group.||6.52|0.48|0.39
91712286|NCT01972464|183316164|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.41|TWO_SIDED|95.0|0.66|3.38||a priori threshold = 0.05|Regression, Cox|Adjusted for age and pre-quit smoking level|Hazard ratio is placebo / progesterone|||3.38|0.66|0.41
91524305|NCT04858802|182923774|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.78||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.007
91616605|NCT00458406|183126642|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
91616606|NCT00458406|183126643|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
91616607|NCT03161938|183126645|SUPERIORITY||Odds Ratio (OR)|0.508||||0.248|TWO_SIDED|95.0|0.159|1.62|||Chi-squared, Corrected|||Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.||1.620|0.159|0.248
91616608|NCT03161938|183126646|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||0.519
91616609|NCT03161938|183126647|SUPERIORITY|||||||0.468|||||||Wilcoxon (Mann-Whitney)|||||||0.468
91616610|NCT03161938|183126648|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||Maximal pain||||0.913
91657056|NCT03587207|183207450|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.59|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||0.86|0.59|
91657057|NCT03587207|183207450|OTHER|NZ98/254 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.62|||||TWO_SIDED|80.0|0.5|0.76|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.76|0.50|
91712287|NCT01972464|183316165|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.001|TWO_SIDED|95.0|0.86|0.96|||general estimating equation|adjusted for age \& pre-quit smoking level; specified a gamma distribution, log link, autoregressive correlation structure|risk ratio is progesterone versus placebo|null hypothesis rate of change in QSU-brief scores were equal between treatment groups||0.96|0.86|<0.001
91712288|NCT00511173|183316172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|4.5|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in \> 100 patients enrolled into each group.||||< 0.05
91712289|NCT02922153|183316175|SUPERIORITY|||||||0.0223|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided, two-sample t-test.||||||0.0223
91712290|NCT02922153|183316176|SUPERIORITY|||||||0.6259|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided two-sample t-test.||||||0.6259
91712291|NCT02922153|183316176|SUPERIORITY|||||||0.518|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon two-sample test.||||||0.518
91712292|NCT02922153|183316177|SUPERIORITY|||||||0.0201||||||FEV1 one-sided, two-sample t-test|t-test, 1 sided|||||||0.0201
91712293|NCT02922153|183316177|SUPERIORITY|||||||0.06||||||FVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.06
91712294|NCT02922153|183316177|SUPERIORITY|||||||0.09||||||SVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.09
91712295|NCT02922153|183316178|SUPERIORITY|||||||0.3085||||||72 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.3085
91712296|NCT02922153|183316178|SUPERIORITY|||||||0.8196||||||96 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.8196
91712297|NCT02922153|183316178|SUPERIORITY|||||||0.7269||||||120 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.7269
91524306|NCT04858802|182923774|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.75||0.034|TWO_SIDED|95.0|-0.4|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 180||0.0|-0.4|0.034
91524307|NCT04858802|182923775|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.65||0.83|TWO_SIDED|95.0|-0.2|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 21||0.2|-0.2|0.830
91616611|NCT03161938|183126648|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||Average pain||||0.722
91712298|NCT02922153|183316180|SUPERIORITY|||||||0.4421|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||Analysis is the time from end of procedure to oral endotracheal extubation||||0.4421
91712299|NCT02922153|183316181|SUPERIORITY|||||||0.4352||||||Total Post-Procedure for Hospital Stay|Wilcoxon (Mann-Whitney)|Wilcoxon Rank-Sum Test||||||0.4352
91712300|NCT02922153|183316182|SUPERIORITY|||||||0.2939||||||ICU Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.2939
91712301|NCT02922153|183316182|SUPERIORITY|||||||0.0998||||||Hospital Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.0998
91712302|NCT02922153|183316183|SUPERIORITY|||||||0.2877|||||||Chi-squared|||48 Hours Post-Op: Patient able to sit up in bed||||0.2877
91712303|NCT02922153|183316183|SUPERIORITY|||||||0.5311|||||||Fisher Exact|||48 Hours Post-Op: Patient able to stand up||||0.5311
91712304|NCT02922153|183316183|SUPERIORITY|||||||0.4908|||||||Fisher Exact|||48 Hours Post-Op: Patient able to walk||||0.4908
91712305|NCT02922153|183316183|SUPERIORITY|||||||0.8621|||||||Fisher Exact|||48 Hours Post-Op: Right Shoulder Flexion Movement||||0.8621
91712306|NCT02922153|183316183|SUPERIORITY|||||||1|||||||Fisher Exact|||48 Hours Post-Op: Left Shoulder Flexion Movement||||1
91712307|NCT02922153|183316183|SUPERIORITY|||||||0.0133|||||||Fisher Exact|||72 Hours Post-Op: Patient able to sit up in bed||||0.0133
91712308|NCT02922153|183316183|SUPERIORITY|||||||0.0037|||||||Fisher Exact|||72 Hours Post-Op: Patient able to stand up||||0.0037
91712309|NCT02922153|183316183|SUPERIORITY|||||||0.1671|||||||Fisher Exact|||72 Hours Post-Op: Patient able to walk||||0.1671
91712310|NCT02922153|183316183|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Right Shoulder Flexion Movement||||1.000
91712311|NCT02922153|183316183|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Left Shoulder Flexion Movement||||1
91712312|NCT02922153|183316183|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Patient able to sit up in bed||||1
91712313|NCT02922153|183316183|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||96 Hours Post-Op: Patient able to stand up||||0.2757
91712314|NCT02922153|183316183|SUPERIORITY|||||||0.9025|||||||Fisher Exact|||96 Hours Post-Op: Patient able to walk||||0.9025
91712315|NCT02922153|183316183|SUPERIORITY|||||||0.7942|||||||Fisher Exact|||96 Hours Post-Op: Right Shoulder Flexion Movement||||0.7942
91712316|NCT02922153|183316183|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Left Shoulder Flexion Movement||||1
91712317|NCT02922153|183316183|SUPERIORITY|||||||0.3492|||||||Fisher Exact|||120 Hours Post-Op: Patient able to sit up in bed||||0.3492
91712318|NCT02922153|183316183|SUPERIORITY|||||||0.2644|||||||Fisher Exact|||120 Hours Post-Op: Patient able to stand up||||0.2644
91712319|NCT02922153|183316183|SUPERIORITY|||||||0.8258|||||||Fisher Exact|||120 Hours Post-Op: Patient able to walk||||0.8258
91712320|NCT02922153|183316183|SUPERIORITY|||||||0.67|||||||Fisher Exact|||120 Hours Post-Op: Right Shoulder Flexion Movement||||0.67
91712321|NCT02922153|183316183|SUPERIORITY|||||||0.5693|||||||Fisher Exact|||120 Hours Post-Op: Left Shoulder Flexion Movement||||0.5693
91712322|NCT02922153|183316183|SUPERIORITY|||||||0.1189|||||||Chi-squared|||Discharge: Patient able to sit up in bed||||0.1189
91712323|NCT02922153|183316183|SUPERIORITY|||||||1|||||||Fisher Exact|||Discharge: Patient able to stand up||||1
91712324|NCT02922153|183316183|SUPERIORITY|||||||0.6992|||||||Fisher Exact|||Discharge: Patient able to walk||||0.6992
91712325|NCT02922153|183316183|SUPERIORITY|||||||0.4429|||||||Fisher Exact|||Discharge: Right Shoulder Flexion Movement||||0.4429
91712326|NCT02922153|183316183|SUPERIORITY|||||||0.4563|||||||Fisher Exact|||Discharge: Left Shoulder Flexion Movement||||0.4563
91712327|NCT03506438|183316184|SUPERIORITY||Mean Difference (Net)|-6.7||||0.018|TWO_SIDED|95.0|-12.2|-1.2|||Mixed Models Analysis|||||-1.2|-12.2|0.018
91712328|NCT03506438|183316185|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed Models Analysis|||||1.1|-0.5|0.48
91712329|NCT03506438|183316186|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.73|TWO_SIDED|95.0|-1.4|1.0|||Mixed Models Analysis|||||1.0|-1.4|0.73
91712330|NCT03506438|183316187|SUPERIORITY||estimated mean difference|0.6||||0.47|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||||2.1|-1.0|0.47
91712331|NCT03506438|183316188|SUPERIORITY||Odds Ratio (OR)|1.8||||0.29|TWO_SIDED|95.0|0.6|5.2|||Regression, Logistic|||||5.2|0.6|0.29
91712332|NCT03506438|183316189|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91712333|NCT03506438|183316190|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91712334|NCT03506438|183316191|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
91524308|NCT04858802|182923775|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.59||0.829|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 45||0.1|-0.2|0.829
91524309|NCT04858802|182923775|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.64||0.132|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 90||0.0|-0.3|0.132
91712335|NCT01053741|183316203|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there is no difference in epithelial surface disruption when comparing the two interventions. Power calculation was based on identifying a median difference in histology grade of 0.83, using a two-sided alpha of 0.05 with 90% power in 10 subjects.||||<0.05
91712336|NCT01001520|183316224|SUPERIORITY_OR_OTHER|||||||0.88||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the right dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.88
91712337|NCT01001520|183316225|SUPERIORITY_OR_OTHER|||||||0.017||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Accuracy was examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would increase subject's accuracy during the N-back working memory task.||||0.017
91712338|NCT01001520|183316226|SUPERIORITY_OR_OTHER|||||||0.88||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would reduce subject's reaction time during the N-back working memory task.||||0.88
91712339|NCT01001520|183316227|SUPERIORITY_OR_OTHER|||||||0.85||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers would smoke fewer cigarettes while taking tolcapone (vs. placebo).||||0.85
91712340|NCT01001520|183316228|SUPERIORITY_OR_OTHER|||||||0.4||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience less cigarette craving during their 24-hour abstinence period.||||0.40
91712341|NCT01001520|183316229|SUPERIORITY_OR_OTHER|||||||0.43||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience fewer withdrawal symptoms during their 24-hour abstinence period.||||0.43
91712342|NCT01001520|183316230|SUPERIORITY_OR_OTHER|||||||0.18||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the left dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.18
91712343|NCT01001520|183316231|SUPERIORITY_OR_OTHER|||||||0.67||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the dorsal cingulate/medial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.67
91524310|NCT04858802|182923775|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.79||0.31|TWO_SIDED|95.0|-0.3|0.1|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 180||0.1|-0.3|0.310
91524311|NCT04858802|182923776|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.48||0.666|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 21||0.1|-0.2|0.666
91616612|NCT03161938|183126649|SUPERIORITY||Odds Ratio (OR)|1.19||||0.768|TWO_SIDED|95.0|0.374|3.793|||Chi-squared, Corrected|||||3.793|0.374|0.768
91616613|NCT03161938|183126650|SUPERIORITY|||||||0.133|||||||Regression, Linear|||||||0.133
91616614|NCT03161938|183126651|SUPERIORITY|||||||0.768||||||Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)|Chi-squared, Corrected|||Day 0||||0.768
91616615|NCT03161938|183126651|SUPERIORITY|||||||0.376|||||||Chi-squared, Corrected|||Day 1||||0.376
91616616|NCT03161938|183126651|SUPERIORITY|||||||0.59|||||||Chi-squared, Corrected|||Day 2||||0.590
91616617|NCT03161938|183126651|SUPERIORITY|||||||0.32|||||||Chi-squared, Corrected|||Day 3||||0.320
91616618|NCT03161938|183126651|SUPERIORITY|||||||0.666|||||||Chi-squared, Corrected|||day 4||||0.666
91616619|NCT03161938|183126652|SUPERIORITY||||||>|0.999|||||||Chi-squared, Corrected|||day 0||||>0.999
91616620|NCT03161938|183126652|SUPERIORITY|||||||0.154|||||||Chi-squared, Corrected|||day 1||||0.154
91616621|NCT03161938|183126652|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 2||||0.447
91616622|NCT03161938|183126652|SUPERIORITY|||||||0.678|||||||Chi-squared, Corrected|||day 3||||0.678
91616623|NCT03161938|183126652|SUPERIORITY|||||||0.604|||||||Chi-squared, Corrected|||day 4||||0.604
91616624|NCT03161938|183126653|SUPERIORITY|||||||0.075|||||||Chi-squared, Corrected|||day 0, sadness||||0.075
91616625|NCT03161938|183126653|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 0, restlessness||||0.447
91712344|NCT01001520|183316232|SUPERIORITY_OR_OTHER|||||||0.98||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the posterior cingulate cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.98
91712345|NCT01001520|183316233|SUPERIORITY_OR_OTHER|||||||0.002||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the ventromedial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.002
91712346|NCT00875563|183316261|NON_INFERIORITY_OR_EQUIVALENCE|An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.||||||0.02|TWO_SIDED||||||Exact test for matched pairs|||Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.||||0.02
91712347|NCT01808261|183316292|OTHER||Mean Difference (Net)|0.0443|STANDARD_ERROR_OF_MEAN|0.0809||0.713||95.0|-0.119|0.2||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 3/Day 90.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.2|-0.119|0.713
91712348|NCT01808261|183316293|OTHER||Mean Difference (Net)|0.0794|STANDARD_ERROR_OF_MEAN|0.0857||0.828|TWO_SIDED|95.0|-0.093|0.247||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 6/Day 180.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.247|-0.093|0.828
91712349|NCT01808261|183316295|OTHER||Mean Difference (Net)|2.408|STANDARD_ERROR_OF_MEAN|2.7495|||TWO_SIDED|95.0|-3.067|7.883||||||Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||7.883|-3.067|
91712350|NCT01808261|183316295|OTHER||Mean Difference (Net)|3.015|STANDARD_ERROR_OF_MEAN|2.8732|||TWO_SIDED|95.0|-2.704|8.735||||||Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||8.735|-2.704|
91712351|NCT01808261|183316295|OTHER||Mean Difference (Net)|2.435|STANDARD_ERROR_OF_MEAN|3.5633|||TWO_SIDED|95.0|-4.668|9.538||||||Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||9.538|-4.668|
91712352|NCT01808261|183316295|OTHER||Mean Difference (Net)|3.944|STANDARD_ERROR_OF_MEAN|3.5635|||TWO_SIDED|95.0|-3.15|11.037||||||Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||11.037|-3.15|
91712353|NCT02585713|183316322|SUPERIORITY|||||||0.1316|||||||Log Rank|||||||0.1316
91616626|NCT03161938|183126653|SUPERIORITY|||||||0.703|||||||Chi-squared, Corrected|||Day 0, fatigue||||0.703
91616627|NCT03161938|183126653|SUPERIORITY|||||||0.731|||||||Chi-squared, Corrected|||Day 1, sadness||||0.731
91712354|NCT02609984|183316324|OTHER||Hazard Ratio (HR)|0.8568||||0.49|TWO_SIDED|95.0|0.5507|1.333||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.3330|0.5507|0.4900
91616628|NCT03161938|183126653|SUPERIORITY|||||||0.052|||||||Chi-squared, Corrected|||Day 1, restlessness||||0.052
91616629|NCT03161938|183126653|SUPERIORITY|||||||0.807|||||||Chi-squared, Corrected|||Day 1, fatigue||||0.807
91616630|NCT03161938|183126653|SUPERIORITY|||||||0.371|||||||Chi-squared, Corrected|||Day 2, sadness||||0.371
91616631|NCT03161938|183126653|SUPERIORITY|||||||0.064|||||||Chi-squared, Corrected|||Day 2, restlessness||||0.064
91616632|NCT03161938|183126653|SUPERIORITY|||||||0.11|||||||Chi-squared, Corrected|||day 2, fatigue||||0.110
91616633|NCT03161938|183126653|SUPERIORITY|||||||0.531|||||||Chi-squared, Corrected|||Day 3, sadness||||0.531
91616634|NCT03161938|183126653|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||Day 3, restlessness||||0.954
91616635|NCT03161938|183126653|SUPERIORITY|||||||0.526|||||||Chi-squared, Corrected|||Day 3, fatigue||||0.526
91616636|NCT03161938|183126653|SUPERIORITY|||||||0.491|||||||Chi-squared, Corrected|||Day 4, sadness||||0.491
91616637|NCT03161938|183126653|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||Day 4, restlessness||||0.042
91616638|NCT03161938|183126653|SUPERIORITY|||||||0.097|||||||Chi-squared, Corrected|||Day 4, fatigue||||0.097
91616639|NCT03161938|183126654|SUPERIORITY|||||||0.613|||||||Chi-squared, Corrected|||||||0.613
91616640|NCT05692154|183126656|SUPERIORITY||Least Square Mean Difference|-4.24|STANDARD_ERROR_OF_MEAN|2.015||0.038|TWO_SIDED|95.0|-8.24|-0.23|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.23|-8.24|0.038
91616641|NCT05692154|183126657|SUPERIORITY||Least Square Mean Difference|-4.75|STANDARD_ERROR_OF_MEAN|2.088||0.025|TWO_SIDED|95.0|-8.9|-0.6|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-0.60|-8.90|0.025
91712355|NCT02609984|183316325|OTHER||Hazard Ratio (HR)|1.2145||||0.4737|TWO_SIDED|95.0|0.7131|2.0684||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.0684|0.7131|0.4737
91712356|NCT02609984|183316329|OTHER|||||||0.3645||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3645
91712357|NCT02609984|183316330|OTHER|||||||0.3466||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3466
91712358|NCT02609984|183316331|OTHER||Hazard Ratio (HR)|0.7006||||0.1622|TWO_SIDED|95.0|0.4241|1.1574||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.1574|0.4241|0.1622
91712359|NCT02609984|183316332|OTHER||Hazard Ratio (HR)|1.1849||||0.6397|TWO_SIDED|95.0|0.5817|2.4134||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.4134|0.5817|0.6397
91524312|NCT04858802|182923776|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.46||0.497|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 45||0.1|-0.2|0.497
91616642|NCT05692154|183126658|SUPERIORITY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|3.247||0.048|TWO_SIDED|95.0|-12.95|-0.05|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.05|-12.95|0.048
91616643|NCT05692154|183126659|SUPERIORITY||Least Square Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.89||0.011|TWO_SIDED|95.0|-13.21|-1.73|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-1.73|-13.21|0.011
91616644|NCT05692154|183126660|SUPERIORITY||Least Square Mean Difference|-18.45|STANDARD_ERROR_OF_MEAN|10.211||0.074|TWO_SIDED|95.0|-38.74|1.83|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TNSS (Day 1) as covariate.|||1.83|-38.74|0.074
91616645|NCT05692154|183126661|SUPERIORITY||Least Square Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|11.672||0.729|TWO_SIDED|95.0|-27.24|19.12|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Day 1) as covariate.|||19.12|-27.24|0.729
91616646|NCT01125176|183126688|OTHER|Exact Clopper-Pearson 95% confidence interval for overall response rate.|Proportion (percent)|85.7|||||TWO_SIDED|95.0|73.5|100.0||||||||100.0|73.5|
91616647|NCT00418262|183126703|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.21|0.3|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.30|-0.21|
91616648|NCT00418262|183126703|SUPERIORITY||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.42|0.6|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.60|-0.42|
91616649|NCT00418262|183126704|SUPERIORITY||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.11|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.11|
91616650|NCT00418262|183126704|SUPERIORITY||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.23|0.77|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.77|-0.23|
91616651|NCT00418262|183126705|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
91712360|NCT02609984|183316333|OTHER|||||||0.1128|||||||exact Pearson chi-square test|||||||0.1128
91712361|NCT02609984|183316334|OTHER||||||<|0.0001|||||||exact Pearson chi-square test|||||||<0.0001
91524313|NCT04858802|182923776|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.5||0.235|TWO_SIDED|95.0|-0.2|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 90||0.0|-0.2|0.235
91616652|NCT00418262|183126705|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
91616653|NCT00418262|183126706|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
91616654|NCT00418262|183126706|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
91616655|NCT00418262|183126707|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
91657058|NCT03587207|183207450|OTHER|M07-0241084 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.52|||||TWO_SIDED|80.0|0.42|0.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.63|0.42|
91657059|NCT03587207|183207450|OTHER|Serogroup A- Between group ratios for comparison between MenABCWY group and MenACWY group|Geometric mean ratio|2.02|||||TWO_SIDED|80.0|1.62|2.51|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||2.51|1.62|
91657060|NCT03587207|183207450|OTHER|Serogroup C- Between group ratios for comparison of MenABCWY group and MenACWY group|Odds Ratio (OR)|4.99|||||TWO_SIDED|80.0|3.92|6.35|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||6.35|3.92|
91657061|NCT03587207|183207450|OTHER|Serogroup W- Between group ratios for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|3.25|||||TWO_SIDED|80.0|2.66|3.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.96|2.66|
91657062|NCT03587207|183207450|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|2.38|||||TWO_SIDED|80.0|1.81|3.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||3.12|1.81|
91657063|NCT03587207|183207454|OTHER|Between group ratio is calculated as GMT for rMenBOMV+ACWY\_S Group over GMT for rMenBOMV+ACWY\_D Group. 80% CI are obtained from Analysis of Covariance model fitted to pooled Serogroup B Strains. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after first vaccination.||1.22|0.86|
91657064|NCT03587207|183207455|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.29|||||TWO_SIDED|80.0|1.02|1.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.63|1.02|
91657065|NCT03587207|183207455|OTHER|96217 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.93|||||TWO_SIDED|80.0|0.75|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.15|0.75|
91712362|NCT02609984|183316335|OTHER|||||||0.405|||||||exact Pearson chi-square test|||||||0.4050
91712363|NCT02609984|183316336|OTHER|||||||0.0127|||||||exact Pearson chi-square test|||||||0.0127
91712364|NCT02080364|183316338|SUPERIORITY|||||||0.3386||||||p-value for comparison to Placebo|Mixed Models Analysis|||||||0.3386
91616656|NCT00418262|183126707|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
91616657|NCT00418262|183126708|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
91657066|NCT03587207|183207455|OTHER|NZ98/254 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.8|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.||1.29|0.80|
91657067|NCT03587207|183207455|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Odds Ratio (OR)|1.08|||||TWO_SIDED|80.0|0.87|1.36|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.36|0.87|
91657068|NCT03587207|183207455|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.77|||||TWO_SIDED|80.0|0.58|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after first vaccination.||1.03|0.58|
91657069|NCT03587207|183207455|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D Group.|Geometric mean ratio|0.84|||||TWO_SIDED|80.0|0.62|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after first vaccination.||1.13|0.62|
91657070|NCT03587207|183207455|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.68|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after first vaccination.||1.13|0.68|
91657071|NCT03587207|183207455|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.76|||||TWO_SIDED|80.0|0.54|1.08|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.08|0.54|
91657072|NCT03587207|183207455|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.09|0.69|
91657073|NCT03587207|183207455|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.58|0.9|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.90|0.58|
91712365|NCT02080364|183316338|SUPERIORITY|||||||0.1992||||||p-value for compairons to Placebo|Mixed Models Analysis|||||||0.1992
91712366|NCT02080364|183316339|SUPERIORITY|||||||0.9394||||||p-value for comparison to Placebo.|Mixed Models Analysis|||||||0.9394
91657074|NCT03587207|183207455|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.61|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.00|0.61|
91657075|NCT03587207|183207455|OTHER|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.68|1.07|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.07|0.68|
91657076|NCT03587207|183207455|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.46|||||TWO_SIDED|80.0|0.35|0.62|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup A, one month after first vaccination.||0.62|0.35|
91657077|NCT03587207|183207455|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.22|||||TWO_SIDED|80.0|0.91|1.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after first vaccination.||1.65|0.91|
91712367|NCT02080364|183316339|SUPERIORITY||||||||||||||||||MMRM model does not converge. LS Mean and p-value are NA.|||
91712368|NCT02256839|183316365|EQUIVALENCE|A 2x2 contingency table with 95% CI.|2 x 2 contingency table|98.1|||||TWO_SIDED|95.0|95.3|99.3||||||||99.3|95.3|
91712369|NCT02256839|183316365|EQUIVALENCE|A 2x2 contingency table with 95% CI|2 x 2 contingency table|96.1|||||TWO_SIDED|95.0|85.4|99.3||||||||99.3|85.4|
91616658|NCT00418262|183126708|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
91616659|NCT00418262|183126709|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.24|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.24|
91616660|NCT00418262|183126709|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.49|0.49|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.49|-0.49|
91616661|NCT00418262|183126710|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.28|0.26|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.26|-0.28|
91616662|NCT00418262|183126710|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.56|0.52|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.52|-0.56|
91616663|NCT00418262|183126711|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.32|0.2|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.20|-0.32|
91616664|NCT00418262|183126711|SUPERIORITY||Median Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.64|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.64|
91616665|NCT00418262|183126712|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-0.28|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.28|
91616666|NCT00418262|183126712|SUPERIORITY||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.57|0.47|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.47|-0.57|
91657078|NCT03587207|183207455|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.34|||||TWO_SIDED|80.0|1.04|1.72|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after first vaccination.||1.72|1.04|
91657079|NCT03587207|183207455|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.98|||||TWO_SIDED|80.0|0.7|1.38|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.38|0.70|
91791361|NCT03720652|183460434|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.56|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.56
91791362|NCT03720652|183460434|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.16|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.16
91616667|NCT00418262|183126713|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
91616668|NCT00418262|183126713|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
91616669|NCT00418262|183126714|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.36|0.13|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.13|-0.36|
91616670|NCT00418262|183126714|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.72|0.27|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.27|-0.72|
91616671|NCT00418262|183126715|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
91616672|NCT00418262|183126715|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
91616673|NCT00418262|183126716|SUPERIORITY||Mean Difference (Net)|-7.4|||||TWO_SIDED|95.0|-7.76|-7.04|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-7.04|-7.76|
91616674|NCT00418262|183126716|SUPERIORITY||Mean Difference (Net)|-2.44|||||TWO_SIDED|95.0|-3.03|-1.9|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-1.90|-3.03|
91657080|NCT03587207|183207455|OTHER|M14459 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.83|1.32|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.32|0.83|
91657081|NCT03587207|183207455|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.64|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.00|0.64|
91657082|NCT03587207|183207455|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.69|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.13|0.69|
91712370|NCT01843803|183316366|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.5||0.029|TWO_SIDED|||||"P-Value = 0.029 after adjusting for clinical and demographic, and accounting for clustering of patients within providers.~Comparison of adjusted CARES score yielded a significant difference."|Mixed Models Analysis|A mixed model was ran with CARES as the dependent variable, adjusted for demographic and clinical measures , and provider as a random effect.||Mixed model adjusted for gender, race, education, marital status, mental health condition, substance disorder, COPD, heart failure, diabetes, coronary artery disease, study site and accounting for clustering of patients within providers.||||0.029
91791363|NCT03720652|183460435|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.15|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.15
91527707|NCT01976364|182930498|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91616675|NCT00418262|183126717|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
91657083|NCT03587207|183207455|OTHER|M07-0241084 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.95|||||TWO_SIDED|80.0|0.76|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.19|0.76|
91657084|NCT03587207|183207455|OTHER|M14459 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.81|||||TWO_SIDED|80.0|0.64|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.03|0.64|
91657085|NCT03587207|183207455|OTHER|96217 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.09|0.69|
91657086|NCT03587207|183207455|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.87|||||TWO_SIDED|80.0|0.68|1.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.12|0.68|
91657087|NCT03587207|183207455|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.88|||||TWO_SIDED|80.0|0.7|1.1|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.10|0.70|
91657088|NCT03587207|183207455|OTHER|M14459 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.71|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.||1.15|0.71|
91657089|NCT03587207|183207455|OTHER|96217 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.58|||||TWO_SIDED|80.0|0.47|0.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.73|0.47|
91657090|NCT03587207|183207455|OTHER|NZ98/254 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.69|||||TWO_SIDED|80.0|0.54|0.89|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||0.89|0.54|
91657091|NCT03587207|183207455|OTHER|M07-0241084 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.82|||||TWO_SIDED|80.0|0.65|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.03|0.65|
91657092|NCT01347710|183207486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
91657093|NCT01347710|183207487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
91657094|NCT01347710|183207487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
91657095|NCT01347710|183207487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI \>/=30|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
91616676|NCT00418262|183126717|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
91616677|NCT00829166|183126719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.549|0.771|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than \[\>\] 1), and visceral/ non-visceral disease.||0.771|0.549|<0.0001
91616678|NCT00829166|183126721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.0006|TWO_SIDED|95.0|0.548|0.849|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.849|0.548|0.0006
91616679|NCT00829166|183126723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749||||0.0003|TWO_SIDED|95.0|0.639|0.877|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.877|0.639|0.0003
91616680|NCT00829166|183126727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.658|||<|0.0001|TWO_SIDED|95.0|0.56|0.774|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.774|0.560|<0.0001
91616681|NCT00829166|183126728|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|12.7||||0.0002|TWO_SIDED|95.0|6.0|19.4|||Mantel-Haenszel chi-squared test||The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||19.4|6.0|0.0002
91616682|NCT00829166|183126730|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|14.0|||||TWO_SIDED|95.0|7.0|20.9|||||The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.|||20.9|7.0|
91616683|NCT00829166|183126732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.703|||<|0.0001|TWO_SIDED|95.0|0.602|0.82|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.820|0.602|<0.0001
91616684|NCT00829166|183126734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0121|TWO_SIDED|95.0|0.667|0.951|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.951|0.667|0.0121
91616685|NCT02538666|183126735|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3693|TWO_SIDED|95.0|0.75|1.12|||Stratified Log Rank|Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS|based on stratified 3-arms Cox proportional hazard model|nivolumab + ipilimumab over placebo||1.12|0.75|0.3693
91616686|NCT02538666|183126736|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.97|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.97|0.68|
91616687|NCT02538666|183126736|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.53|1.66|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab over China Placebo||1.66|0.53|
91616688|NCT02538666|183126737|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.36|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global nivolumab||1.36|0.94|
91616689|NCT02538666|183126737|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.56|1.79|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China nivolumab||1.79|0.56|
91616690|NCT02538666|183126738|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.62|0.88|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global placebo||0.88|0.62|
91616691|NCT02538666|183126738|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.55|0.79|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.79|0.55|
91616692|NCT02538666|183126738|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.35|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab+ ipilimumab over nivolumab||1.35|0.94|
91616693|NCT02538666|183126738|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.33|1.12|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China placebo||1.12|0.33|
91616694|NCT02538666|183126738|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.24|0.85|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab over China placebo||0.85|0.24|
91616695|NCT02538666|183126738|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.72|2.49|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China Nivolumab||2.49|0.72|
91616696|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.61|1.15|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.15|0.61|
91657096|NCT01347710|183207488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.891|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress|Z test|z test for non inferiority for specificity||||||0.891
91791364|NCT03720652|183460435|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.12|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.12
91712371|NCT01843803|183316368|SUPERIORITY||Odds Ratio (OR)|1.69||||0.065|TWO_SIDED|95.0|0.99|2.86||P-Value derived after adjusting model provider clustering and treating it as a random effect.|Mixed Models Analysis|||Assessed whether a person in the intervention group vs the attention control group was more likely to be probed at least once by their provider after adjusting for other measures and accounting for the provider clustering.||2.86|0.99|.065
91712372|NCT01843803|183316369|SUPERIORITY||||||<|0.05|||||||Chi-squared|||chi-square||||<0.05
91712373|NCT01850394|183316370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|180.0|STANDARD_DEVIATION|300.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91712374|NCT01850394|183316370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|150.0|STANDARD_DEVIATION|200.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91712375|NCT01850394|183316371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91712376|NCT01850394|183316371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91712377|NCT01850394|183316372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
91712378|NCT01850394|183316373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
91712379|NCT01850394|183316374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0|||||ANOVA|||||||0.05
91712380|NCT00436826|183316398|SUPERIORITY||Relative Risk|0.37|||<|0.001|TWO_SIDED|95.0|0.22|0.63|||Wald Chi-square|||||0.63|0.22|<0.001
91712381|NCT00121719|183316430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146|||||||Wilcoxon signed-rank test|||This was a pilot study and a statistical sample size calculation was not performed.||||0.0146
91712382|NCT00784719|183316436|SUPERIORITY_OR_OTHER||Median|59.0|||||TWO_SIDED|80.0|57.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||57.0|
91712383|NCT00784719|183316436|SUPERIORITY_OR_OTHER||Median|58.0|||||TWO_SIDED|80.0|58.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||58.0|
91616697|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.55|1.04|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||1.04|0.55|
91712384|NCT00784719|183316436|SUPERIORITY_OR_OTHER||Median|57.0|||||TWO_SIDED|80.0|29.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||29.0|
91616698|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.42|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||0.92|0.42|
91712385|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|9.0|28.0||||||||28.0|9.0|
91712386|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|8.5|||||TWO_SIDED|80.0|8.0|27.0||||||||27.0|8.0|
91712387|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|15.0|27.0||||||||27.0|15.0|
91712388|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|9.5|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
91712389|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|9.0|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
91712390|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|8.0|43.0||||||||43.0|8.0|
91712391|NCT00784719|183316438|SUPERIORITY_OR_OTHER||Median|16.0|||||TWO_SIDED|80.0|15.0|30.0||||||||30.0|15.0|
91712392|NCT05568797|183316469|NON_INFERIORITY|The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (\<=) 1.5.|GMT Ratio|1.32|||||TWO_SIDED|0.95|1.13|1.53|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.53|1.13|
91712393|NCT05568797|183316469|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.91|1.18|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.18|0.91|
91712394|NCT05568797|183316469|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.97|||||TWO_SIDED|0.95|0.9|1.06|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.06|0.90|
91616699|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.44|0.93|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.93|0.44|
91616700|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.68|1.21|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||1.21|0.68|
91712395|NCT05568797|183316469|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.95|1.13|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.13|0.95|
91712396|NCT05568797|183316470|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-A neutralizing antibody vaccine is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|0.95|0.87|1.12|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.12|0.87|
91712397|NCT05568797|183316471|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-B neutralizing antibody vaccine is \<=1.5.|GMT Ratio|1.16|||||TWO_SIDED|0.95|1.03|1.3|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the CoAd Group and Day 61 for the Control Group).||1.30|1.03|
91657097|NCT01347710|183207488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.546|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients|z test|z test for non-inferiority for specificity||||||.546
91657098|NCT01347710|183207488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.538|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI \>/=30|z test|z test for non-inferiority for specificity||||||.538
91712398|NCT05568797|183316472|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|10.25|||||TWO_SIDED|0.95|3.5|16.9||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||16.90|3.50|
91712399|NCT05568797|183316472|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|1.66|||||TWO_SIDED|0.95|-5.16|8.47||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||8.47|-5.16|
91712400|NCT05568797|183316472|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.25|||||TWO_SIDED|0.95|-4.92|5.46||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||5.46|-4.92|
91712401|NCT05568797|183316472|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.79|||||TWO_SIDED|0.95|-4.54|6.17||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||6.17|-4.54|
91712402|NCT02651337|183316483|OTHER|It is a one arm clinical study. No comparison between groups was made.|||||||||||||||||The study tested the hypothesis that the Alivio flusher could increase flow in occluded or sluggish flowing catheters. Analysis was made on the basis of the procedural results related to priming the flusher, connecting the flusher to the shunt, flushing the system by dome compression, the ability to refill the dome, and the ability to evacuate the dome.|||
91712403|NCT00869128|183316499|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANOVA|The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||||0.04
91712404|NCT03828214|183316521|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|9.2||0.973|TWO_SIDED|||||a priori threshold for statistical significance was 0.05.|ANOVA|||C2, C3, C4 were compared to C1 the comparison condition.||||0.973
91657099|NCT01347710|183207489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|McNemar|Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD||||||<0.001
91712405|NCT04388176|183316529|EQUIVALENCE|Differences in treatment groups in the primary endpoint (log (AUC)) was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0146|||=|0.3801|TWO_SIDED|90.0|0.9859|1.0442|||ANCOVA|||||1.0442|0.9859|=0.3801
91791365|NCT03720652|183460435|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.018|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.018
91791366|NCT03720652|183460436|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.33|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.33
91791367|NCT03720652|183460436|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.88|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.88
91791368|NCT03720652|183460436|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.67|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.67
91791369|NCT03720652|183460437|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91791370|NCT03720652|183460437|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91791371|NCT03720652|183460437|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91712406|NCT04388176|183316530|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0346|||=|0.0356|TWO_SIDED|90.0|1.0086|1.0613|||ANCOVA|||||1.0613|1.0086|=0.0356
91524314|NCT04858802|182923776|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.41||0.677|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 180||0.1|-0.1|0.677
91712407|NCT04388176|183316531|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Difference in least square means|-0.4991|||=|0.0154|TWO_SIDED|90.0|-0.8234|-0.1749|||ANCOVA|||Analysis at the 10 min point||-0.1749|-0.8234|=0.0154
91657100|NCT01347710|183207489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX||||||<0.001
91657101|NCT01347710|183207489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA||||||<0.001
91657102|NCT01347710|183207489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD||||||<0.001
91712408|NCT04388176|183316532|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|0.8301|||=|0.282|TWO_SIDED|90.0|0.6206|1.1102|||ANCOVA|||||1.1102|0.6206|=0.282
91791372|NCT03720652|183460438|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.17
91791373|NCT03720652|183460438|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
91791374|NCT03720652|183460438|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.062|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.062
91791375|NCT03720652|183460439|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.013|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.013
91791376|NCT03720652|183460439|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
91791377|NCT03720652|183460439|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.003|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.003
91791378|NCT03720652|183460440|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
91712409|NCT04388176|183316533|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.3989|||=|0.3722|TWO_SIDED|90.0|-1.1718|0.3739|||ANCOVA|||||0.3739|-1.1718|=0.3722
91712410|NCT04388176|183316534|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.109|||=|0.4982|TWO_SIDED|90.0|-0.4074|0.1895|||ANCOVA|||Analysis of capillaroscopy before cold||0.1895|-0.4074|=0.4982
91657103|NCT01347710|183207490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.379|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|z Test|z test for non-inferiority for specificity; LAD||||||.379
91524315|NCT04858802|182923777|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|2.48||0.868|TWO_SIDED|95.0|-0.7|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 21||0.6|-0.7|0.868
91657104|NCT01347710|183207490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.358|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|Z Test|z test for non-inferiority for specificity; LCX||||||.358
91712411|NCT04388176|183316534|EQUIVALENCE|A difference between treatment groups was detected with a power of 90% and alpha=0.1|Difference in least square means|-0.0637|||=|0.6219|TWO_SIDED|90.0|-0.3037|0.1763|||ANCOVA|||Analysis of capillaroscopy post recovery||0.1763|-0.3037|=0.6219
91712412|NCT01689441|183316535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
91712413|NCT01689441|183316536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.51
91616701|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||1.18|0.66|
91616702|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.35|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.35|0.81|
91616703|NCT02538666|183126739|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||1.20|0.72|
91616704|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.09|0.58|
91616705|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.5|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||0.92|0.50|
91616706|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.5|1.07|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||1.07|0.50|
91616707|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.95|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.95|0.46|
91616708|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.54|0.96|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||0.96|0.54|
91616709|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||0.89|0.49|
91616710|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.01|0.60|
91712414|NCT01689441|183316537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
91712415|NCT00534638|183316577|SUPERIORITY||Vaccine effectiveness percentage|49.6||||0.004|TWO_SIDED|95.0|20.1|68.2||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||68.2|20.1|0.004
91616711|NCT02538666|183126740|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||0.89|0.53|
91616712|NCT02538666|183126741|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||Stratified Log Rank||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over Global placebo||1.09|0.76|
91616713|NCT02538666|183126741|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.52|1.67|||Stratified Log Rank||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China placebo||1.67|0.52|
91616714|NCT00320385|183126742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.93|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||0.93|0.57|0.008
91616715|NCT00320385|183126743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.106|TWO_SIDED|95.0|0.53|1.07|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||1.07|0.53|0.106
91712416|NCT00534638|183316577|SUPERIORITY||Vaccine effectiveness percentage|23.8||||0.232|TWO_SIDED|95.0|-19.0|51.1||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||51.1|-19.0|0.232
91712417|NCT00534638|183316578|SUPERIORITY||Vaccine effectiveness percentage|-52.2||||0.069|TWO_SIDED|95.0|-139.4|3.3||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.||3.3|-139.4|0.069
91712418|NCT00282152|183316596|NON_INFERIORITY|Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.||||||0.968|||||||Log Rank|||||||0.968
91712419|NCT00282152|183316597|OTHER|||||||0.4|||||||t-test, 2 sided|||Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.||||0.40
91616716|NCT00320385|183126744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.46|TWO_SIDED|95.0|0.6|3.9|||Fisher Exact||Responses were compared between treatment arms using stratified Fisher's exact tests.|||3.9|0.6|0.460
91616717|NCT00320385|183126745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.01|TWO_SIDED|95.0|1.2|4.5|||Fisher Exact||Clinical Benefit was compared between treatment arms using stratified Fisher's exact tests.|||4.5|1.2|0.010
91616718|NCT04370028|183126750|SUPERIORITY||Mean Difference (Net)|4.57|||<|1e-05|TWO_SIDED|95.0|4.42|4.72|||t-test, 2 sided|Paired test was performed||||4.72|4.42|<0.00001
91616719|NCT04370028|183126751|SUPERIORITY||Odds Ratio (OR)|7.2|||<|1e-05|TWO_SIDED|95.0|6.01|8.67|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<26 was assessed||8.67|6.01|<0.00001
91616720|NCT04370028|183126752|SUPERIORITY||Odds Ratio (OR)|5.31|||<|1e-05|TWO_SIDED|95.0|4.28|6.64|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<17 was assessed||6.64|4.28|<0.00001
91616721|NCT04370028|183126753|SUPERIORITY||Mean Difference (Net)|2.375|||<|0.07|TWO_SIDED|95.0|-0.21|4.96|||ANOVA|||Change of mean MoCA score||4.96|-0.21|<0.07
91616722|NCT04370028|183126753|SUPERIORITY||Mean Difference (Net)|4.74|||<|0.01|TWO_SIDED|95.0|4.17|5.31|||ANOVA|||Change of mean MoCA score||5.31|4.17|<0.01
91657105|NCT01347710|183207490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.442|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|z Test|z test for non-inferiority for specificity; RCA||||||.442
91657106|NCT01347710|183207490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.984|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|z Test|z test for non-inferiority for specificity; non-LAD||||||.984
91616723|NCT04370028|183126753|SUPERIORITY||Mean Difference (Net)|4.55|||<|0.01|TWO_SIDED|95.0|4.16|4.94|||ANOVA|||Change of mean MoCA score||4.94|4.16|<0.01
91616724|NCT04370028|183126753|SUPERIORITY||Mean Difference (Net)|4.49|||<|0.01|TWO_SIDED|95.0|3.7|5.27|||ANOVA|||Change of mean MoCA score||5.27|3.7|<0.01
91616725|NCT04370028|183126755|SUPERIORITY||Mean Difference (Net)|0.803|STANDARD_ERROR_OF_MEAN|0.246||0.0011|TWO_SIDED|95.0|0.321|1.28|||ANOVA|||||1.28|0.321|0.0011
91657107|NCT01347710|183207491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease|McNemar|p-Value based on two-sided McNemar's (Chi squared) test superiority||||||<0.001
91616726|NCT02492750|183126757|OTHER||Maximum Tolerated Dose (MTD) Level|3.0|||||TWO_SIDED||||||||MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.|||||
91616727|NCT01954121|183126812|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.|adjusted difference in proportions|-22.9|||||TWO_SIDED|95.0|-33.1|-12.6||||||The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and \>2 seizures) as covariates.||-12.6|-33.1|
91616728|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
91712420|NCT01237327|183316622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7799||||0.3348|TWO_SIDED|95.0|0.47|1.294|||Log Rank|||Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.||1.294|0.47|0.3348
91712421|NCT01919164|183316635|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Descriptive statistics was provided for primary endpoint.||0.03|-0.01|
91712422|NCT01919164|183316635|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.01|0.04||||||Descriptive statistics was provided for primary endpoint.||0.04|-0.01|
91712423|NCT01919164|183316635|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.06||||||Descriptive statistics was provided for primary endpoint.||0.06|0.02|
91712424|NCT01919164|183316635|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||Descriptive statistics was provided for primary endpoint.||0.07|0.03|
91712425|NCT03782987|183316649|OTHER||Geometric mean (gMean) ratio (%) (T/ R)|649.48|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|541.29|779.29|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||779.29|541.29|
91712426|NCT03782987|183316650|OTHER||gMean ratio (%) (T/ R)|166.88|STANDARD_ERROR_OF_MEAN|17.7|||TWO_SIDED|90.0|148.42|187.64|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||187.64|148.42|
91712427|NCT03782987|183316651|OTHER||gMean ratio (%) (T/ R)|931.41|STANDARD_ERROR_OF_MEAN|25.9|||TWO_SIDED|90.0|785.19|1104.85|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||1104.85|785.19|
91712428|NCT01116921|183316708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.006|TWO_SIDED|95.0|0.13|0.7|||Regression, Logistic|||||0.70|0.13|0.006
91712429|NCT04155463|183316716|OTHER||Median Percent Change|-18.4||||0.17|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for all participants. Interquartile range for this was -37.4 to 29.8.|Based on previous pesticide research, we calculated a sample size of 40 participants to provide a power of 0.80 at a 0.05 significance level in a two-sided test. We assumed a standard deviation of 0.5 µg/L.||||0.17
91712430|NCT04155463|183316716|OTHER||Median Percent Change|-24.2||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for far-field participants. Interquartile range for this was -37.4 to -8.8.|||||0.06
91712431|NCT04155463|183316716|OTHER||Median Percent Change|1.4||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for near-field participants. Interquartile range for this was -41.9 to 43.0.|||||0.83
91616729|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
91657108|NCT01347710|183207492|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.827|TWO_SIDED|||||p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease|z test|p-Value based on one-sided z test for non-inferiority||||||0.827
91712432|NCT00113295|183316722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.05||||||No adjustment for multiple testing|t-test, 2 sided||This analysis applies to the additional reduction from phase 2 randomization to phase 2 endpoint in HAM-A scores.|In phase 2, comprising randomized double-blind quetiapine augmentation, change scores were examined with two-tailed, two-sample t tests, utilizing scores at phase 2 randomization as baseline. All analyses were intention to treat (ITT) with the last visit carried forward (LVCF) for subjects that did not complete the study.||||<0.05
91712433|NCT04878055|183316739|SUPERIORITY||Odds Ratio (OR)|1.626||||0.216|TWO_SIDED|95.0|0.752|3.514|||Two-sided regression, Logistic|||Analysis is based on logistic regression model with Multiple Imputation under missing not at random using retrieve dropouts with proportion of patients alive and free of respiratory failure at Day 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.||3.514|0.752|0.216
91712434|NCT04878055|183316740|SUPERIORITY|||||||0.377|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||||||0.377
91712435|NCT04878055|183316741|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Date 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.|Odds Ratio (OR)|0.468||||0.17|TWO_SIDED|95.0|0.158|1.386|||Two-sided regression, Logistic|||||1.386|0.158|0.17
91712436|NCT04878055|183316742|SUPERIORITY||Odds Ratio (OR)|0.561||||0.168|TWO_SIDED|95.0|0.247|1.277|||Regression, Logistic|||||1.277|0.247|0.168
91657109|NCT01347710|183207493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity||||||<0.001
91712437|NCT04878055|183316743|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. Estimates were calculated taking into account the following competing risks: Death, discontinuation for AEs and patient transferred to another institution.||||||0.167|||||||Gray's Test|||Until Day 28||||0.167
91712438|NCT04878055|183316744|SUPERIORITY|||||||0.55||||||Comparison between treatment arms is performed by means of a Fisher's Exact test.|Fisher Exact|||At Day 3 - please note that the number of subjects is 268 (180+88) and not 270.||||0.55
91712439|NCT04878055|183316744|SUPERIORITY|||||||0.128|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared mean.||At Day 7 - Please note that the total of subjects in this analysis is not 270 but 266 (n=179 in the Reparixin group and n=87 in the placebo group).||||0.128
91616730|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
91616731|NCT03342469|183126839|OTHER|||||||0.08||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.08
91712440|NCT04878055|183316744|SUPERIORITY|||||||0.235|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 14 - Please note that the total of subjects in this analysis is not 270 but 256 (n=173 in the Reparixin group and n=83 in the placebo group).||||0.235
91616732|NCT03342469|183126839|OTHER|||||||0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,14)= 4.55||Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.05
91616733|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
91616734|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
91657110|NCT01347710|183207494|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.945|ONE_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI|Z Test|one-sided z test for non-inferiority for specificity||||||.945
91712441|NCT04878055|183316744|SUPERIORITY|||||||0.281|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 21 - Please note that the total of subjects in this analysis is not 270 but 255 (n=172 in the Reparixin group and n=83 in the placebo group).||||0.281
91712442|NCT04878055|183316744|SUPERIORITY|||||||0.273|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 90 - Please note that the total of subjects in this analysis is not 270 but 50 (n=33 in the Reparixin group and n=17 in the placebo group).||||0.273
91712443|NCT04878055|183316745|SUPERIORITY|||||||0.047||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 3 - Please note that the number of subjects in this analysis is not 270 but 255||||0.047
91712444|NCT04878055|183316745|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.262
91712445|NCT04878055|183316745|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 14 - Please note that the number of subjects in this analysis is not 270 but 209||||0.367
91712446|NCT04878055|183316745|SUPERIORITY|||||||0.882||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 21 - Please note that the number of subjects in this analysis is not 270 but 176||||0.882
91712447|NCT04878055|183316745|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 28 - Please note that the number of subjects in this analysis is not 270 but 190||||0.19
91616735|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
91616736|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)||||>0.05
91616737|NCT03342469|183126839|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616738|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91657111|NCT01347710|183207495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.954|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good|z Test|p-Value based on on-sided z test for non-inferiority for specificity||||||0.954
91657112|NCT01347710|183207496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
91657113|NCT01347710|183207497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||McNemar|p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT||||||<0.001
91657114|NCT04591626|183207500|SUPERIORITY||LS Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.14|-0.77|||Mixed Models Analysis|||||-0.77|-1.14|<0.001
91657115|NCT04591626|183207501|SUPERIORITY||Odds Ratio (OR)|10.91|||<|0.001|TWO_SIDED|95.0|5.35|22.28|||Regression, Logistic|||||22.28|5.35|<0.001
91657116|NCT04591626|183207502|SUPERIORITY||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.77|-0.6|||Mixed Models Analysis|||||-0.60|-1.77|<0.001
91657117|NCT04591626|183207503|SUPERIORITY||LS Mean Difference|-14.82|||<|0.001|TWO_SIDED|95.0|-20.57|-9.08|||Mixed Models Analysis|||||-9.08|-20.57|<0.001
91657118|NCT04591626|183207504|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using Logistic Regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
91657119|NCT04591626|183207505|SUPERIORITY||Odds Ratio (OR)|7.59|||<|0.001|TWO_SIDED|95.0|4.27|13.48|||Regression, Logistic||OR was determined using logistic regression model: Variable = Baseline HbA1c value + OAM use + Treatment as variables.|||13.48|4.27|<0.001
91657120|NCT04591626|183207506|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using logistic regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
91657121|NCT04591626|183207507|SUPERIORITY||LS Mean Difference|-26.3|||<|0.001|TWO_SIDED|95.0|-33.0|-19.6|||Mixed Models Analysis|||||-19.6|-33.0|<0.001
91657122|NCT04591626|183207508|SUPERIORITY||LS Mean Difference|-4.0||||0.006|TWO_SIDED|95.0|-6.86|-1.14|||Mixed Models Analysis|||||-1.14|-6.86|0.006
91657123|NCT02003183|183207525|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.1|<|0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis applies to the Amygdala.||||<0.02
91657124|NCT03676803|183207526|OTHER||Mean Difference (Final Values)|10.6||||0.033|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.||||0.033
91657125|NCT03676803|183207526|OTHER||Mean Difference (Final Values)|8.7||||0.097|TWO_SIDED|||||p\<0.05 was defined as significant.|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.||||0.097
91657126|NCT03676803|183207527|OTHER||Mean Difference (Final Values)|86.0||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in mixed spices intervention group||||0.49
91657127|NCT03676803|183207527|OTHER||Mean Difference (Final Values)|55.7||||0.53|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in placebo group||||0.53
91657128|NCT01355081|183207547|SUPERIORITY_OR_OTHER||Least square means difference|-2.03|STANDARD_ERROR_OF_MEAN|1.241||0.1031|TWO_SIDED|95.0|-4.467|0.413|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||0.413|-4.467|0.1031
91657129|NCT01355081|183207547|SUPERIORITY_OR_OTHER||Least square mean difference|-1.04|STANDARD_ERROR_OF_MEAN|1.233||0.4008|TWO_SIDED|95.0|-3.461|1.387|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||1.387|-3.461|0.4008
91616739|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91712448|NCT04878055|183316745|SUPERIORITY|||||||0.161||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||At Day 60 - Please note that the number of subjects in this analysis is not 270 but 201||||0.161
91616740|NCT03342469|183126840|OTHER|||||||0.04||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1.14)= 4.88, p=0.04||"Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||0.04
91616741|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616742|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616743|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616744|NCT03342469|183126840|OTHER||||||>|0.05|||||||repeated measures General Linear Model|||"Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons"||||>0.05
91616745|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616746|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91657130|NCT02719522|183207571|SUPERIORITY|The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%|||||<|0.001|||||||Clopper-Pearson|||The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%. Missing safety data for subjects who were lost to FU without any evidence of a major stroke/death were imputed in the analysis using multiple imputation. Subjects who withdrew from the study prior to completion and had experienced a major stroke or death were counted towards the primary safety endpoint as having experienced the event.||||<0.001
91657131|NCT01868009|183207583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The response was analyzed and adjusted for study inhaler use sequence and preference question version. The method accounted for participants who indicated no preference.|Cochran-Mantel-Haenszel|||||||<0.001
91712449|NCT04878055|183316745|SUPERIORITY|||||||0.853|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 90 - Please note that the number of subjects in this analysis is not 270 but 18||||0.853
91712450|NCT04878055|183316745|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At EOS - Please note that the number of subjects in this analysis is not 270 but 229||||0.068
91616747|NCT03342469|183126840|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616748|NCT03342469|183126841|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,15) = 3.65, p = 0.08||"Difference in inattentive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616749|NCT03342469|183126841|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in hyperactive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616750|NCT03342469|183126841|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616751|NCT03342469|183126841|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"inattentive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91657132|NCT04603937|183207586|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-4.7|STANDARD_ERROR_OF_MEAN|0.97|>|0.9999|TWO_SIDED|95.04|-6.65|-2.81|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.81|-6.65|> 0.9999
91712451|NCT04878055|183316745|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 195||||0.672
91712452|NCT04878055|183316745|SUPERIORITY|||||||0.153|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At end of treatment (EoT) - Please note that the number of subjects in this analysis is not 270 but 241||||0.153
91712453|NCT04878055|183316746|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Death, reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.07|||||||Grey's test|||||||0.07
91616752|NCT03342469|183126841|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Hyperactive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616753|NCT03342469|183126841|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
91616754|NCT05515601|183126844|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.986|||||TWO_SIDED|90.0|0.929|1.05||||||||1.05|0.929|
91712454|NCT04878055|183316747|SUPERIORITY|||||||0.07|||||||Gray's test|||number of patients included in the analysis=25||||0.07
91616755|NCT05515601|183126845|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.948|1.08||||||||1.08|0.948|
91616756|NCT05515601|183126846|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability|Ratio of Geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.960|
91616757|NCT00540436|183126859|SUPERIORITY_OR_OTHER||Mean change|33.49||||||95.0|15.231|51.744||||||||51.744|15.231|
91616758|NCT00540436|183126860|SUPERIORITY_OR_OTHER||Mean change|46.82||||||95.0|24.566|69.076||||||||69.076|24.566|
91616759|NCT01515306|183126870|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|1.09|||||TWO_SIDED|90.0|0.93|1.29|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.||||1.29|0.93|
91616760|NCT01515306|183126872|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.83|1.13|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.||||1.13|0.83|
91616761|NCT01064648|183126887|OTHER||Hazard Ratio (HR)|0.71||||0.06|TWO_SIDED|80.0|0.54|0.95||1-sided p-value|Log Rank|Stratified log rank test by performance status and histology type.||||0.95|0.54|0.06
91616762|NCT01064648|183126888|OTHER||Hazard Ratio (HR)|0.88||||0.28|TWO_SIDED|80.0|0.65|1.17||1-sided p-value|Log Rank|Stratified log-rank test by performance status and histology.||||1.17|0.65|0.28
91616763|NCT01064648|183126889|OTHER||Odds Ratio (OR)|1.85||||0.15|TWO_SIDED|95.0|0.59|5.83||1-sided p-value|Chi-squared|Stratified Chi-square by performance status and histology.||||5.83|0.59|0.15
91616764|NCT01064648|183126890|OTHER||Odds Ratio (OR)|0.45||||0.09|TWO_SIDED|95.0|0.14|1.49||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.49|0.14|0.09
91616765|NCT01064648|183126891|OTHER||Odds Ratio (OR)|4.3||||0.006|TWO_SIDED|95.0|1.4|13.3||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology.||||13.3|1.4|0.006
91616766|NCT01064648|183126892|OTHER||Odds Ratio (OR)|0.59||||0.19|TWO_SIDED|95.0|0.18|1.94||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.94|0.18|0.19
91616767|NCT05513391|183126895|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio was greater than (\>) 0.667 for each virus strain.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.948|1.73||||||Statistical analysis for A/H1N1||1.73|0.948|
91616768|NCT05513391|183126895|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|2.53|||||TWO_SIDED|95.0|1.93|3.3||||||Statistical analysis for A/H3N2||3.30|1.93|
91616769|NCT05513391|183126895|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|0.515|||||TWO_SIDED|95.0|0.397|0.668||||||Statistical analysis for B/Victoria||0.668|0.397|
91616770|NCT05513391|183126895|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.799|1.3||||||Statistical analysis for B/Yamagata||1.30|0.799|
91616771|NCT05513391|183126896|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|7.1|||||TWO_SIDED|95.0|-1.55|15.7||||||Statistical analysis for A/H1N1||15.7|-1.55|
91616772|NCT05513391|183126896|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|15.4|||||TWO_SIDED|95.0|5.8|24.7||||||Statistical analysis for A/H3N2||24.7|5.80|
91616773|NCT05513391|183126896|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|-6.91|||||TWO_SIDED|95.0|-14.02|0.1||||||Statistical analysis for B/Victoria||0.10|-14.02|
91616774|NCT05513391|183126896|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|5.81|||||TWO_SIDED|95.0|-1.99|13.6||||||Statistical analysis for B/Yamagata||13.6|-1.99|
91616775|NCT02429427|183126905|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.751|TWO_SIDED|95.0|0.8|1.17|||Log Rank|Analysis stratified by oestrogen receptor status and country.|Analysis stratified by oestrogen receptor status and country.|||1.17|0.80|0.751
91616776|NCT02429427|183126906|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.781|TWO_SIDED|95.0|0.76|1.22|||Log Rank|Analysis is stratified for oestrogen receptor status and country.|Analysis is stratified for oestrogen receptor status and country.|||1.22|0.76|0.781
91616777|NCT05138783|183126957|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, and sequence) and random (subject) effects. Difference = PRECISION1 minus BIOTRUE. Sign (either negative or positive) is retained with the rounded value.|||0.00||
91616778|NCT03364335|183126958|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5461|||||||ANCOVA|||||||0.5461
91616779|NCT03364335|183126958|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0364|||||||ANCOVA|||||||0.0364
91616780|NCT03364335|183126958|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0156|||||||ANCOVA|||||||0.0156
91616781|NCT03364335|183126958|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0349|||||||ANCOVA|||||||0.0349
91616782|NCT03364335|183126959|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5348|||||||ANCOVA|||||||0.5348
91616783|NCT03364335|183126959|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0379|||||||ANCOVA|||||||0.0379
91616784|NCT03364335|183126959|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0215|||||||ANCOVA|||||||0.0215
91616785|NCT03364335|183126959|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0464|||||||ANCOVA|||||||0.0464
91616786|NCT03364335|183126960|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||1|||||||Chi-squared|||||||1.0000
91616787|NCT03364335|183126960|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.2646|||||||Chi-squared|||||||0.2646
91616788|NCT03364335|183126960|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.0749|||||||Chi-squared|||||||0.0749
91616789|NCT03364335|183126960|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.6758|||||||Chi-squared|||||||0.6758
91616790|NCT03364335|183126961|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.9656|||||||ANCOVA|||||||0.9656
91616791|NCT03364335|183126961|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.4254|||||||ANCOVA|||||||0.4254
91616792|NCT03364335|183126961|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.1276|||||||ANCOVA|||||||0.1276
91616793|NCT03364335|183126961|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.5937|||||||ANCOVA|||||||0.5937
91657133|NCT04603937|183207587|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
91616794|NCT03364335|183126962|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.601|||||||ANCOVA|||||||0.6010
91616795|NCT03364335|183126962|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6513|||||||ANCOVA|||||||0.6513
91616796|NCT03364335|183126962|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4354|||||||ANCOVA|||||||0.4354
91616797|NCT03364335|183126962|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.031|||||||ANCOVA|||||||0.0310
91616798|NCT03364335|183126963|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4644|||||||ANCOVA|||||||0.4644
91616799|NCT03364335|183126963|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8573|||||||ANCOVA|||||||0.8573
91616800|NCT03364335|183126963|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8167|||||||ANCOVA|||||||0.8167
91616801|NCT03364335|183126963|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.9223|||||||ANCOVA|||||||0.9223
91616802|NCT03364335|183126964|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6574|||||||ANCOVA|||||||0.6574
91616803|NCT03364335|183126964|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8971|||||||ANCOVA|||||||0.8971
91616804|NCT03364335|183126964|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6317|||||||ANCOVA|||||||0.6317
91616805|NCT03364335|183126964|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.0341|||||||ANCOVA|||||||0.0341
91616806|NCT03364335|183126965|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.372|||||||ANCOVA|||||||0.3720
91616807|NCT03364335|183126965|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.2302|||||||ANCOVA|||||||0.2302
91616808|NCT03364335|183126965|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.1377|||||||ANCOVA|||||||0.1377
91616809|NCT03364335|183126965|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4295|||||||ANCOVA|||||||0.4295
91524316|NCT04858802|182923777|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|2.3||0.823|TWO_SIDED|95.0|-0.5|0.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 45||0.7|-0.5|0.823
91524317|NCT04858802|182923777|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.26||1|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 90||0.5|-0.5|1.00
91524318|NCT04858802|182923777|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.16||0.188|TWO_SIDED|95.0|-0.8|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 180||0.2|-0.8|0.188
91524319|NCT04858802|182923781|SUPERIORITY||Mean Difference (Net)|6.28|STANDARD_DEVIATION|18.12||0.025|TWO_SIDED|95.0|0.8|11.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|||11.7|0.8|0.025
91524320|NCT04858802|182923782|SUPERIORITY||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|12.49||0.04|TWO_SIDED|95.0|0.2|7.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||7.8|0.2|0.04
91524321|NCT04858802|182923782|SUPERIORITY||Median Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.02||0.09|TWO_SIDED|95.0|-7.5|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.6|-7.5|0.09
91524322|NCT04858802|182923783|SUPERIORITY||Mean Difference (Final Values)|61.54|STANDARD_DEVIATION|460.18||0.375|TWO_SIDED|95.0|-76.7|199.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||199.8|-76.7|0.375
91524323|NCT04858802|182923783|SUPERIORITY||Mean Difference (Final Values)|-51.98|STANDARD_DEVIATION|434.64||0.432|TWO_SIDED|95.0|-184.1|80.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||80.2|-184.1|0.432
91524324|NCT04858802|182923784|SUPERIORITY||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.13||0.023|TWO_SIDED|95.0|0.1|1.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||1.4|0.1|0.023
91616810|NCT03364335|183126966|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.6726|||||||ANCOVA|||||||0.6726
91657134|NCT04603937|183207588|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e the non-inferiority margin is 10%|Difference of weighted percentages|1.2|||<|0.0001|TWO_SIDED|95.04|-1.4|3.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||3.9|-1.4|<0.0001
91524325|NCT04858802|182923784|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|2.24||0.646|TWO_SIDED|95.0|-0.8|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.8|0.646
91524326|NCT00332332|182923785|SUPERIORITY_OR_OTHER||Percentage of participants|73.5||||||95.0|67.2|79.1||||||||79.1|67.2|
91524327|NCT03091673|182923799|OTHER||||||<|0.001||||||P-value was computed using a t-test to determine if change in plasma glucose from baseline to 30 minutes was zero.|t-test, 2 sided|||||||<0.001
91524328|NCT02714868|182923816|OTHER|||||||0.05|||||||t-test, 2 sided|||For goal attainment, we calculated independent t-tests to compare GAS t-scores across groups at outcome. Lowest score is 0, highest score is 100. 100 is highest goal attainment.||||.05
91524329|NCT05056870|182923827|SUPERIORITY|Superiority was declared if the upper limit of the 95% confidence interval of was below 0.00 logMAR.|Mean Difference|-0.097|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.113|-0.081|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.081|-0.113|
91616811|NCT03364335|183126966|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.7934|||||||ANCOVA|||||||0.7934
91616812|NCT03364335|183126966|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.5485|||||||ANCOVA|||||||0.5485
91657135|NCT02585258|183207592|SUPERIORITY||mean difference over 2-years|-0.37|||<|0.0001|ONE_SIDED|95.0||-0.23||one-sided.|Mixed Models Analysis||placebo is reference. Negative difference is beneficial, means lower disease activity in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.23||<0.0001
91524330|NCT05056870|182923828|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 0.|Mean Difference|28.0|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|22.6|33.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||33.3|22.6|
91524331|NCT05056870|182923829|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR.|Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|-0.032|-0.008|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.008|-0.032|
91712455|NCT04878055|183316748|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.668|||||||Gray's test|||Comparison at day 28||||0.668
91712456|NCT04878055|183316749|SUPERIORITY|||||||0.668|||||||Gray's test|||Number of patients included in the analysis = 59||||0.668
91712457|NCT04878055|183316750|SUPERIORITY|||||||0.23|||||||Gray's test|||Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||0.23
91712458|NCT04878055|183316751|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||day 3 - please note that the number of subjects in this analysis is not 270 but 255||||0.444
91712459|NCT04878055|183316751|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||day 7 - please note that the number of subjects in this analysis is not 270 but 246||||0.357
91524332|NCT05056870|182923830|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 1.|Mean Ratio|2.98|||||TWO_SIDED|95.0|1.73|5.11|||Generalized Linear Mixed Model||Mean Ratio was calculated as Test over Control|||5.11|1.73|
91616813|NCT03364335|183126966|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.3676|||||||ANCOVA|||||||0.3676
91657136|NCT02585258|183207593|SUPERIORITY||Risk Ratio (RR)|1.24||||0.02|ONE_SIDED|95.0|1.04|||one-sided|GEE||prednisolone/placebo|mixed model reports the effect of treatment, adjusted for stratification factors|||1.04|0.02
91657137|NCT02585258|183207594|SUPERIORITY||mean differences over 2 years|-1.67||||0.003|ONE_SIDED|95.0||-0.68||one-sided|Regression, Linear||placebo is reference. Negative difference means less damage progression in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.68||0.003
91657138|NCT02848326|183207632|SUPERIORITY||Least squares mean difference|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.0039|TWO_SIDED|95.0|-1.93|-0.37||Mixed-effects model for repeated measures (MMRM) model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.37|-1.93|0.0039
91657139|NCT02848326|183207632|SUPERIORITY||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.33||0.0056|TWO_SIDED|95.0|-1.55|-0.27||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.27|-1.55|0.0056
91657140|NCT02848326|183207632|SUPERIORITY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.0325|TWO_SIDED|95.0|-1.35|-0.06||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.06|-1.35|0.0325
91657141|NCT02848326|183207632|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.42||0.001|TWO_SIDED|95.0|-2.21|-0.56||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.56|-2.21|0.0010
91712460|NCT04878055|183316751|SUPERIORITY|||||||0.484|||||||Wilcoxon (Mann-Whitney)|||day 14 - please note that the number of subjects in this analysis is not 270 but 209||||0.484
91712461|NCT04878055|183316751|SUPERIORITY|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||day 21 - please note that the number of subjects in this analysis is not 270 but 176||||0.753
91712462|NCT04878055|183316751|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||day 28 - please note that the number of subjects in this analysis is not 270 but 190||||0.26
91712463|NCT04878055|183316751|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||day 60 - please note that the number of subjects in this analysis is not 270 but 201||||0.19
91712464|NCT04878055|183316751|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||day 90 - please note that the number of subjects in this analysis is not 270 but 18||||1.000
91712465|NCT04878055|183316751|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||EOS - please note that the number of subjects in this analysis is not 270 but 229||||0.074
91616814|NCT03364335|183126967|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1653|||||||ANCOVA|||||||0.1653
91616815|NCT03364335|183126967|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.197|||||||ANCOVA|||||||0.1970
91616816|NCT03364335|183126967|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.0608|||||||ANCOVA|||||||0.0608
91616817|NCT03364335|183126967|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1583|||||||ANCOVA|||||||0.1583
91616818|NCT03364335|183126968|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.0524|||||||ANCOVA|||||||0.0524
91616819|NCT03364335|183126968|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5221|||||||ANCOVA|||||||0.5221
91616820|NCT03364335|183126968|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3702|||||||ANCOVA|||||||0.3702
91616821|NCT03364335|183126968|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5426|||||||ANCOVA|||||||0.5426
91616822|NCT03364335|183126969|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.1843|||||||ANCOVA|||||||0.1843
91524333|NCT01373931|182923872|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.976|||||TWO_SIDED|90.0|0.907|1.05|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.05|0.907|
91524334|NCT01373931|182923872|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.914|||||TWO_SIDED|90.0|0.842|0.991|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||0.991|0.842|
91616823|NCT03364335|183126969|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.4411|||||||ANCOVA|||||||0.4411
91616824|NCT03364335|183126969|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.6991|||||||ANCOVA|||||||0.6991
91616825|NCT03364335|183126969|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3721|||||||ANCOVA|||||||0.3721
91657142|NCT02848326|183207632|SUPERIORITY||Least squares mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.41||0.0016|TWO_SIDED|95.0|-2.09|-0.49||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.49|-2.09|0.0016
91657143|NCT02848326|183207633|SUPERIORITY||Least squares mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.43||0.0014|TWO_SIDED|95.0|-2.23|-0.54||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-2.23|0.0014
91657144|NCT02848326|183207633|SUPERIORITY||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.36||0.0005|TWO_SIDED|95.0|-1.94|-0.55||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.55|-1.94|0.0005
91657145|NCT02848326|183207633|SUPERIORITY||Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.36||0.0087|TWO_SIDED|95.0|-1.64|-0.24||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.24|-1.64|0.0087
91657146|NCT02848326|183207633|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46||0.0044|TWO_SIDED|95.0|-2.2|-0.41||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.41|-2.20|0.0044
91657147|NCT02848326|183207633|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.44||0.0017|TWO_SIDED|95.0|-2.26|-0.53||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.53|-2.26|0.0017
91657148|NCT02848326|183207634|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0617|TWO_SIDED|95.0|0.98|2.31||Generalized linear mixed model (GLMM) for repeated measures with fixed factors(treatment group,visit), covariates(baseline migraine days), interactions(treatment group;baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.31|0.98|0.0617
91657149|NCT02848326|183207634|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0369|TWO_SIDED|95.0|1.02|2.08||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.08|1.02|0.0369
91657150|NCT02848326|183207634|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0512|TWO_SIDED|95.0|1.0|2.03||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.03|1.00|0.0512
91657151|NCT02848326|183207634|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0113|TWO_SIDED|95.0|1.15|2.91||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.91|1.15|0.0113
91657152|NCT02848326|183207634|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0019|TWO_SIDED|95.0|1.3|3.18||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measure|||||3.18|1.30|0.0019
91657153|NCT02848326|183207635|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.0002|TWO_SIDED|95.0|-1.99|-0.6||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.60|-1.99|0.0002
91657154|NCT02848326|183207635|SUPERIORITY||Least squares mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.01|-0.87||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.87|-2.01|<0.0001
91657155|NCT02848326|183207635|SUPERIORITY||Least squares mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|-1.68|-0.54||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-1.68|0.0001
91657156|NCT02848326|183207635|SUPERIORITY||Least squares mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.08|-0.62||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.62|-2.08|0.0003
91657157|NCT02848326|183207635|SUPERIORITY||Least squares mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.36||0.0007|TWO_SIDED|95.0|-1.93|-0.52||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.52|-1.93|0.0007
91712466|NCT04878055|183316751|SUPERIORITY|||||||0.193|||||||two-sample Mann-Whitney U test|||EOT - please note that the number of subjects in this analysis is not 270 but 241||||0.193
91712467|NCT04878055|183316751|SUPERIORITY|||||||0.131|||||||two-sample Mann-Whitney U test|||Hospital discharge - please note that the number of subjects in this analysis is not 270 but 195||||0.131
91712468|NCT04878055|183316752|SUPERIORITY|||||||0.997|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270 but 155.||||0.997
91712469|NCT04878055|183316752|SUPERIORITY|||||||0.712|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270 but 143.||||0.712
91712470|NCT04878055|183316752|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270 but 115.||||0.241
91712471|NCT04878055|183316752|SUPERIORITY|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270 but 92.||||0.528
91524335|NCT01373931|182923873|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.73|0.51|||Wilcoxon Signed Rank Test|Median difference is for ethinyl estradiol.||||0.51|-0.73|
91524336|NCT01373931|182923873|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon Signed Rank Test|Median difference is for norelgestromin.||||0.50|-0.50|
91657158|NCT00890981|183207637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.0766||95.0|-0.4|7.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction||7.8|-0.4|0.0766
91712472|NCT04878055|183316752|SUPERIORITY|||||||0.814|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270 but 106.||||0.814
91524337|NCT01373931|182923874|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.07||||||90.0|1.0|1.15|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.15|1.00|
91524338|NCT01373931|182923874|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.0||||||90.0|0.944|1.07|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||1.07|0.944|
91524339|NCT01175148|182923893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED||||||Fisher Exact|||The study used a minimax Simon two-stage design to test the null hypothesis Ho: P \> 0.35 versus the alternative H1: \< 0.15, where P is the probability of grade 2 to 4 acute GVHD at day + 100.||||<0.05
91657159|NCT00890981|183207638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1648||95.0|-0.6|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.6|0.1648
91657160|NCT00890981|183207639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.0228||95.0|0.1|1.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.7|0.1|0.0228
91657161|NCT00890981|183207640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.656||95.0|-2.5|4.0|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.||4.0|-2.5|0.6560
91657162|NCT00890981|183207641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0594||95.0|-0.1|3.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.7|-0.1|0.0594
91657163|NCT00890981|183207642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0032||95.0|0.9|4.3|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||4.3|0.9|0.0032
91712473|NCT04878055|183316752|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||at EOT - Please note that the number of subjects in this analysis is not 270 but 115.||||0.242
91712474|NCT04878055|183316752|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||at hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 65.||||0.722
91712475|NCT04878055|183316753|SUPERIORITY|||||||0.053|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 246.||||0.053
91712476|NCT04878055|183316753|SUPERIORITY|||||||0.245|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 225.||||0.245
91712477|NCT04878055|183316753|SUPERIORITY|||||||0.067|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 118.||||0.067
91712478|NCT04878055|183316753|SUPERIORITY|||||||0.051|||||||two-sample Mann-Whitney U test|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 54.||||0.051
91524340|NCT01010477|182923910|SUPERIORITY_OR_OTHER|||||||0.632||||||threshold for statistical significance: p\< 0.05|Fisher Exact|||Fisher Exact test (2-sided)||||0.632
91527476|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|40.95|STANDARD_ERROR_OF_MEAN|19.38||0.035|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression||The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.|The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope \& intercept model. The analysis included the fixed, categorical effects of treatment, ATA status \& gender, fixed continuous effects of time \& baseline FVC (mL), age and height as well as the treatment-by time \& baseline-by-time interactions. Random effects was included for patient response for both time \& intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix||79.01|2.88|0.0350
91712479|NCT04878055|183316753|SUPERIORITY|||||||0.684|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 32.||||0.684
91712480|NCT04878055|183316753|SUPERIORITY|||||||1|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 246, but it is 14.||||1.00
91712481|NCT04878055|183316753|SUPERIORITY|||||||0.48|||||||two-sample Mann-Whitney U test|||at Day 60 - Please note that the number of subjects in this analysis is not 246, but it is 3.||||0.48
91712482|NCT04878055|183316753|SUPERIORITY|||||||0.638|||||||two-sample Mann-W hitney U test|||at Hospital discharge - Please note that the number of subjects in this analysis is 152.||||0.638
91712483|NCT04878055|183316753|SUPERIORITY|||||||0.137|||||||two-sample Mann-W hitney U test|||at EoT - Please note that the number of subjects in this analysis is 212.||||0.137
91712484|NCT04878055|183316754|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 157||||0.399
91712485|NCT04878055|183316754|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 139||||0.07
91616826|NCT03364335|183126970|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.0318|||||||ANCOVA|||||||0.0318
91616827|NCT03364335|183126970|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.3827|||||||ANCOVA|||||||0.3827
91616828|NCT03364335|183126970|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.005|||||||ANCOVA|||||||0.0050
91712486|NCT04878055|183316754|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 73||||0.4
91712487|NCT04878055|183316754|SUPERIORITY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 23||||0.517
91712488|NCT04878055|183316754|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 17||||0.445
91657164|NCT00890981|183207643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.2897||95.0|-0.4|1.2|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.2|-0.4|0.2897
91616829|NCT03364335|183126970|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.1045|||||||ANCOVA|||||||0.1045
91616830|NCT04710862|183126971|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
91616831|NCT04710862|183126972|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
91616832|NCT04710862|183126973|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
91616833|NCT04710862|183126974|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91616834|NCT04710862|183126975|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91616835|NCT04710862|183126976|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91616836|NCT04710862|183126977|SUPERIORITY|||||||0.328|||||||Mixed Models Analysis|||||||0.328
91657165|NCT00890981|183207644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.0067||95.0|1.1|6.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||6.7|1.1|0.0067
91616837|NCT03725202|183126978|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|17.1|||=|0.0019|TWO_SIDED|95.0|6.3|27.8|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||27.8|6.3|=0.0019
91712489|NCT04878055|183316754|SUPERIORITY|||||||0.324|||||||Wilcoxon (Mann-Whitney)|||at EoT - Please note that the number of subjects in this analysis is not 270, but it is 113||||0.324
91712490|NCT04878055|183316754|SUPERIORITY|||||||0.752|||||||Wilcoxon (Mann-Whitney)|||at Hospital discharge - Please note that the number of subjects in this analysis is not 270, but it is 67.||||0.752
91712491|NCT04878055|183316755|SUPERIORITY|||||||0.447|||||||two-sample Mann-Whitney U test|||Please note that the number of patients in this analysis is not 270 but 255, because patients who used supplement oxygen were 174 in the Reparixin group and 81 in the placebo group.||||0.447
91712492|NCT04878055|183316756|SUPERIORITY|||||||0.065||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||At day 28 - Please note that the number of patients in this analysis is not 270 but 245, because patients requiring IMV or ECMO were 163 in the Reparixin group and 82 in the placebo group.||||0.065
91712493|NCT04878055|183316756|SUPERIORITY|||||||0.072|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test||||||0.072
91712494|NCT04878055|183316757|SUPERIORITY|||||||0.485||||||Number of subjects included in analysis: 98|two-sample Mann-Whitney U test|||||||0.485
91712495|NCT04878055|183316758|SUPERIORITY|||||||0.267|||||||two-sample Mann-Whitney U test|||Number of subjects included in analysis: 17||||0.267
91712496|NCT04878055|183316759|SUPERIORITY|||||||0.137|||||||two-sample Mann-Whitney U test|||||||0.137
91712497|NCT04878055|183316760|SUPERIORITY|||||||0.002|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is 168||||0.002
91712498|NCT04878055|183316760|SUPERIORITY|||||||0.943|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 168, but it is 146||||0.943
91712499|NCT04878055|183316760|SUPERIORITY|||||||0.88|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 168, but it is 76||||0.88
91616838|NCT03725202|183126978|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|12.1|||=|0.0579|TWO_SIDED|95.0|-0.4|24.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||24.6|-0.4|=0.0579
91616839|NCT03725202|183126979|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.7|||<|0.0001|TWO_SIDED|95.0|11.3|30.2|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||30.2|11.3|<0.0001
91616840|NCT03725202|183126979|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|9.9|||=|0.0699|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||20.6|-0.8|=0.0699
91616841|NCT03725202|183126980|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
91616842|NCT03725202|183126980|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
91616843|NCT03725202|183126981|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.57|||=|0.0025|TWO_SIDED|95.0|0.399|0.826|||Log-rank test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.826|0.399|=0.0025
91616844|NCT03725202|183126981|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.75|||=|0.1778|TWO_SIDED|95.0|0.499|1.136|||Log-rank test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.136|0.499|=0.1778
91616845|NCT03725202|183126982|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.47|||=|0.0014|TWO_SIDED|95.0|0.29|0.74|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.74|0.29|=0.0014
91657166|NCT00890981|183207645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0184||95.0|0.4|3.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.8|0.4|0.0184
91657167|NCT00890981|183207646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.0911||95.0|-0.3|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.3|0.0911
91657168|NCT00890981|183207647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0035||95.0|0.7|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|0.7|0.0035
91712500|NCT04878055|183316760|SUPERIORITY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 168, but it is 38||||0.458
91712501|NCT04878055|183316760|SUPERIORITY|||||||0.285|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 168, but it is 23.||||0.285
91712502|NCT04878055|183316760|SUPERIORITY|||||||0.885|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 168, but it is 8||||0.885
91712503|NCT04878055|183316760|SUPERIORITY||||||=|0.583|||||||two-sample Mann-Whitney U test|||at HD - Please note that the number of subjects in this analysis is not 270, but it is 74||||= 0.583
91712504|NCT04878055|183316760|SUPERIORITY|||||||0.5|||||||two-sample Mann-Whitney U test|||at End of treatment - Please note that the number of subjects in this analysis is not 270, but it is 131.||||0.5
91712505|NCT04878055|183316761|SUPERIORITY|||||||0.005||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 245||||0.005
91616846|NCT03725202|183126982|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.6|||=|0.0633|TWO_SIDED|95.0|0.35|1.03|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.03|0.35|=0.0633
91616847|NCT03725202|183126983|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|30.3|||<|0.0001|TWO_SIDED|95.0|20.4|40.2|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||40.2|20.4|<0.0001
91616848|NCT03725202|183126983|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||35.3|11.7|<0.0001
91616849|NCT03725202|183126984|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.8|||=|0.0002|TWO_SIDED|95.0|9.7|31.9|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||31.9|9.7|=0.0002
91616850|NCT03725202|183126984|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|3.2|||=|0.6276|TWO_SIDED|95.0|-9.6|16.0|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||16.0|-9.6|=0.6276
91616851|NCT03725202|183126985|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.7526|STANDARD_ERROR_OF_MEAN|1.1981|=|0.0019|TWO_SIDED|95.0|1.3932|6.1119|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.1119|1.3932|=0.0019
91712506|NCT04878055|183316761|SUPERIORITY|||||||0.283||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 221||||0.283
91657169|NCT00890981|183207648|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.1||||0.0591||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0591
91657170|NCT00890981|183207649|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.2||||0.0079||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0079
91616852|NCT03725202|183126985|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.6094|STANDARD_ERROR_OF_MEAN|1.4185|=|0.067|TWO_SIDED|95.0|-0.1841|5.4028|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||5.4028|-0.1841|=0.0670
91616853|NCT03725202|183126986|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.6||||0.001|TWO_SIDED|95.0|0.4|0.8|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.8|0.4|0.0010
91616854|NCT03725202|183126986|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.8|||=|0.2722|TWO_SIDED|95.0|0.6|1.2|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.2|0.6|=0.2722
91712507|NCT04878055|183316761|SUPERIORITY|||||||0.512||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 117||||0.512
91712508|NCT04878055|183316761|SUPERIORITY|||||||0.174|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 51||||0.174
91616855|NCT03725202|183126987|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.0036|TWO_SIDED|95.0|1.33|6.76|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.76|1.33|=0.0036
91616856|NCT03725202|183126987|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|1.63|=|0.0338|TWO_SIDED|95.0|0.27|6.7|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.70|0.27|=0.0338
91616857|NCT03725202|183126988|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.7325|STANDARD_ERROR_OF_MEAN|2.9635|=|0.3573|TWO_SIDED|95.0|-3.102|8.567|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||8.5670|-3.1020|=0.3573
91616858|NCT03725202|183126988|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|5.4216|STANDARD_ERROR_OF_MEAN|3.4785|=|0.1203|TWO_SIDED|95.0|-1.4269|12.2701|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||12.2701|-1.4269|=0.1203
91616859|NCT03725202|183126989|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|1.1|||=|0.4371|TWO_SIDED|95.0|0.8|1.6|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.6|0.8|=0.4371
91616860|NCT03725202|183126989|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.9|||=|0.7749|TWO_SIDED|95.0|0.6|1.4|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.4|0.6|=0.7749
91712509|NCT04878055|183316761|SUPERIORITY|at EOT - Please note that the number of subjects in this analysis is not 270, but it is 206||||||0.133|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.133
91791379|NCT03720652|183460440|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.01|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.010
91712510|NCT04878055|183316761|SUPERIORITY|||||||0.009|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 28 ± 2 - Please note that the number of subjects in this analysis is not 270, but it is 29||||0.009
91791380|NCT03720652|183460440|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.085|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.085
91616861|NCT00948818|183126990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||0.0004|TWO_SIDED|95.0|1.51|4.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||4.47|1.51|0.0004
91616862|NCT00948818|183126992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.26|5.88||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||5.88|2.26|<0.0001
91616863|NCT00948818|183126993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0262|TWO_SIDED|95.0|1.04|1.91||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||1.91|1.04|0.0262
91616864|NCT00948818|183126994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.4|2.66||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||2.66|1.40|<0.0001
91616865|NCT01156597|183127004|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values||||||0.05
91616866|NCT02364947|183127007|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|0.87||0.0001|TWO_SIDED|95.0|-6.05|-2.62||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.62|-6.05|0.0001
91616867|NCT02364947|183127007|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-6.05|-2.32||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.32|-6.05|0.0001
91616868|NCT02364947|183127008|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-5.69|-2.16|||Mixed Models Analysis|||||-2.16|-5.69|<0.0001
91616869|NCT02364947|183127008|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.54|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.46|-2.63|||Mixed Models Analysis|||||-2.63|-6.46|<0.0001
91616870|NCT02364947|183127009|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.47|STANDARD_ERROR_OF_MEAN|2.72|<|0.0001|TWO_SIDED|95.0|-17.81|-7.13|||Mixed Models Analysis|||Change in total alcohol consumption (TAC) from baseline at Week 12||-7.13|-17.81|<0.0001
91616871|NCT02364947|183127009|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|95.0|-18.72|-7.15|||Mixed Models Analysis|||||-7.15|-18.72|<0.0001
91616872|NCT02364947|183127010|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.15|STANDARD_ERROR_OF_MEAN|2.86||0.0001|TWO_SIDED|95.0|-16.77|-5.53|||Mixed Models Analysis|||||-5.53|-16.77|0.0001
91657171|NCT03290326|183207668|OTHER||||||<|0.01|||||||ANOVA|||One-way ANOVA was conducted to compare the effect of 40Hz tACS on EEG gamma-band spectral power. Power changes were expressed as percentage relative power variations, accordingly with the event-related synchronization/desynchronization (ERS/ERD) index.||||< 0.01
91657172|NCT03765502|183207722|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
91657173|NCT03765502|183207723|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
91657174|NCT00048568|183207729|SUPERIORITY_OR_OTHER||Estimated Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.8|36.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.|The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.||36.7|19.8|<0.001
91657175|NCT00048568|183207730|SUPERIORITY_OR_OTHER||Estimated Difference|24.4|||<|0.001|TWO_SIDED|95.0|15.9|32.9||Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.|Chi-squared, Corrected|This model includes treatment as the main factor and baseline value as a covariate.|Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.|||32.9|15.9|<0.001
91657176|NCT00048568|183207731|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Nonparametric ANCOVA|The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.||||||0.029
91657177|NCT00048568|183207735|SUPERIORITY_OR_OTHER||Estimated Difference|33.4|||<|0.001|TWO_SIDED|95.0|25.1|41.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.|||41.7|25.1|<0.001
91657178|NCT00048568|183207737|SUPERIORITY_OR_OTHER||Estimated Difference|23.0|||<|0.001|TWO_SIDED|95.0|15.0|31.1|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.|||31.1|15.0|<0.001
91657179|NCT00048568|183207738|SUPERIORITY_OR_OTHER||Estimated Difference|30.1|||<|0.001|TWO_SIDED|95.0|21.8|38.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.|||38.5|21.8|<0.001
91616873|NCT02364947|183127010|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.27|STANDARD_ERROR_OF_MEAN|3.11||0.0003|TWO_SIDED|95.0|-17.37|-5.17|||Mixed Models Analysis|||||-5.17|-17.37|0.0003
91616874|NCT02364947|183127011|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|22.0|||<|0.0001|TWO_SIDED|95.0|13.6|30.4|||Cochran-Mantel-Haenszel|||||30.4|13.6|<0.0001
91616875|NCT02364947|183127011|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|15.7||||0.0007|TWO_SIDED|95.0|6.5|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.5|0.0007
91616876|NCT02364947|183127012|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|18.0||||0.0002|TWO_SIDED|95.0|8.8|27.2|||Cochran-Mantel-Haenszel|||||27.2|8.8|0.0002
91616877|NCT02364947|183127012|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|20.6||||0.0001|TWO_SIDED|95.0|10.4|30.8|||Cochran-Mantel-Haenszel|||||30.8|10.4|0.0001
91616878|NCT02364947|183127013|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|10.5|25.1|||Cochran-Mantel-Haenszel|||||25.1|10.5|<0.0001
91616879|NCT02364947|183127013|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.3||||0.0002|TWO_SIDED|95.0|6.4|22.2|||Cochran-Mantel-Haenszel|||||22.2|6.4|0.0002
91616880|NCT02364947|183127014|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|11.0||||0.0079|TWO_SIDED|95.0|2.9|19.1|||Cochran-Mantel-Haenszel|||||19.1|2.9|0.0079
91616881|NCT02364947|183127014|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|5.8|23.9|||Cochran-Mantel-Haenszel|||||23.9|5.8|0.0010
91616882|NCT02364947|183127015|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|9.9||||0.0022|TWO_SIDED|95.0|3.5|16.3|||Cochran-Mantel-Haenszel|||||16.3|3.5|0.0022
91616883|NCT02364947|183127015|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|11.1||||0.0016|TWO_SIDED|95.0|3.8|18.3|||Cochran-Mantel-Haenszel|||||18.3|3.8|0.0016
91616884|NCT02364947|183127016|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|13.6||||0.0003|TWO_SIDED|95.0|6.2|20.9|||Cochran-Mantel-Haenszel|||||20.9|6.2|0.0003
91616885|NCT02364947|183127016|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|12.8||||0.0013|TWO_SIDED|95.0|4.6|21.0|||Cochran-Mantel-Haenszel|||||21.0|4.6|0.0013
91616886|NCT02364947|183127017|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|15.2||||0.0002|TWO_SIDED|95.0|7.1|23.3|||Cochran-Mantel-Haenszel|||||23.3|7.1|0.0002
91616887|NCT02364947|183127017|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|17.9||||0.0001|TWO_SIDED|95.0|8.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.9|0.0001
91616888|NCT02364947|183127018|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|8.0||||0.0724|TWO_SIDED|95.0|-0.7|16.7|||Cochran-Mantel-Haenszel|||||16.7|-0.7|0.0724
91616889|NCT02364947|183127018|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|19.6||||0.0001|TWO_SIDED|95.0|9.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|9.9|0.0001
91616890|NCT02364947|183127019|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|0.0002
91616891|NCT02364947|183127019|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Mixed Models Analysis|||||-0.15|-0.45|0.0001
91616892|NCT02364947|183127020|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.48|-0.18|||Mixed Models Analysis|||||-0.18|-0.48|<0.0001
91657180|NCT00048568|183207740|SUPERIORITY_OR_OTHER||Estimated Difference|13.3|||<|0.001|TWO_SIDED|95.0|7.0|19.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.|||19.5|7.0|<0.001
91657181|NCT00048568|183207741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.001|TWO_SIDED|95.0|15.6|29.8|||Chi-squared, Corrected|||||29.8|15.6|<0.001
91657182|NCT00048568|183207743|SUPERIORITY_OR_OTHER||Estimated Difference|12.3|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.|||17.2|7.3|<0.001
91657183|NCT00048568|183207744|SUPERIORITY_OR_OTHER||Estimated Difference on Day 169|-1.15|||<|0.001|TWO_SIDED|95.0|-1.38|-0.91|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 169.|||-0.91|-1.38|<0.001
91657184|NCT00048568|183207744|SUPERIORITY_OR_OTHER||Estimated Difference on Day 365|-1.39|||<|0.001|TWO_SIDED|95.0|-1.63|-1.16|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 365.|||-1.16|-1.63|<0.001
91657185|NCT00048568|183207748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 169|4.06|||<|0.001|TWO_SIDED|95.0|2.64|5.57|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.57|2.64|<0.001
91657186|NCT00048568|183207748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 365|4.15|||<|0.001|TWO_SIDED|95.0|2.69|5.62|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.62|2.69|<0.001
91657187|NCT00048568|183207749|SUPERIORITY_OR_OTHER||Estimated Difference|5.7||||0.002|TWO_SIDED|95.0|2.4|9.0|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.|||9.0|2.4|0.002
91657188|NCT03831048|183207880|NON_INFERIORITY|The primary analysis of this endpoint will be performed using a linear probability model, with the following terms in the model: (1) treatment; and (2) the known donor and recipient risk factors listed above. Variables that make the model fail to converge will be dropped from the model. The test will be conducted at the one-sided 0.05 level of significance.|Mean Difference (Final Values)|-0.032|||<|0.0001|TWO_SIDED|90.0|-0.098|0.034||No multiple comparison adjustment.|Regression, Linear|||"The null and alternative hypotheses for the primary endpoint are as follows:~H0: pSOC - pDCD ≥ 0.20 vs. H1: pSOC - pDCD \< 0.20 where pDCD and pSOC represent the true survival proportions at the six months follow-up visit for DCD and SOC heart transplant patients, respectively."||0.034|-0.098|<0.0001
91657189|NCT03831048|183207881|OTHER|No hypothesis test.||||||||||||||||No null hypothesis test.|No statistical hypothesis testing. This endpoint will be summarized for the OCS Heart Population using counts and percentages and an exact (Clopper-Pearson) 95% confidence interval for the true percentage based on the binomial distribution. It will also be summarized for the modified OCS Heart Population, defined as the number of DCD hearts that were successfully transplanted after preservation and assessment on the OCS divided by the total number of DCD donor hearts that were instrumented on the OCS.|||
91657190|NCT00324168|183207948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009||||0.82|TWO_SIDED|95.0|-0.085|0.068|||Regression, Linear|Adjusted for enrollment BSCVA||||0.068|-0.085|0.82
91657191|NCT00324168|183207949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.4|TWO_SIDED|95.0|-0.09|0.15|||Regression, Linear|||||0.15|-0.09|0.40
91657192|NCT00324168|183207950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.873|TWO_SIDED|95.0|-0.07|0.08|||Regression, Linear|||||0.08|-0.07|0.873
91657193|NCT00324168|183207951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.44|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox|||||1.12|0.76|0.44
91657194|NCT00324168|183207952|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
91657195|NCT00324168|183207953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.12|0.05|||Regression, Linear|||||0.05|-0.12|0.39
91657196|NCT00324168|183207954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.78||95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.78
91657197|NCT00324168|183207955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3|TWO_SIDED|95.0|-0.011|0.35|||Regression, Linear|||Nocardia spp||0.35|-.011|0.30
91657198|NCT00324168|183207955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.86||95.0|-0.12|0.1|||Regression, Linear|||Streptococcus pneumoniae||0.10|-0.12|0.86
91657199|NCT00324168|183207955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.65|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|||Moraxella spp||0.55|-0.34|0.65
91657200|NCT00324168|183207955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.67|TWO_SIDED|95.0|-0.2|0.13|||Regression, Linear|||Pseudomonas aeruginosa||0.13|-0.20|0.67
91657201|NCT00324168|183207956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.33|TWO_SIDED|95.0|-0.08|0.25|||Regression, Linear|||\<20/40||0.25|-0.08|0.33
91657202|NCT00324168|183207956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||Regression, Linear|||20/40 to 20/800||0.11|-0.09|0.85
91657203|NCT00324168|183207956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.03|TWO_SIDED|95.0|-0.31|-0.02|||Regression, Linear|||CF or worse||-0.02|-0.31|0.03
91657204|NCT00324168|183207957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.05|0.17|||Regression, Linear|||\>0-33%||0.17|-0.05|0.31
91657205|NCT00324168|183207957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.94|TWO_SIDED|95.0|-0.13|0.14|||Regression, Linear|||\>33%-67%||0.14|-0.13|0.94
91657206|NCT00324168|183207957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||\>67%-100%||0.01|-0.31|0.07
91616893|NCT02364947|183127020|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Analysis|||||-0.19|-0.51|<0.0001
91616894|NCT02364947|183127021|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.69|-0.33|||Mixed Models Analysis|||||-0.33|-0.69|<0.0001
91616895|NCT02364947|183127021|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.27|||Mixed Models Analysis|||||-0.27|-0.67|<0.0001
91616896|NCT02364947|183127022|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.31|||Mixed Models Analysis|||||-0.31|-0.70|<0.0001
91616897|NCT02364947|183127022|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.77|-0.33|||Mixed Models Analysis|||||-0.33|-0.77|<0.0001
91616898|NCT02364947|183127023|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.192|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.262|-0.121|||Mixed Models Analysis|||||-0.121|-0.262|<0.0001
91616899|NCT02364947|183127023|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.039||0.0001|TWO_SIDED|95.0|-0.232|-0.08|||Mixed Models Analysis|||||-0.080|-0.232|0.0001
91791381|NCT03720652|183460441|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91616900|NCT02364947|183127024|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.248|-0.088|||Mixed Models Analysis|||||-0.088|-0.248|<0.0001
91616901|NCT02364947|183127024|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.044||0.0017|TWO_SIDED|95.0|-0.226|-0.052|||Mixed Models Analysis|||||-0.052|-0.226|0.0017
91616902|NCT02364947|183127025|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.031||0.0234|TWO_SIDED|95.0|-0.13|-0.009|||Mixed Models Analysis|||||-0.009|-0.130|0.0234
91616903|NCT02364947|183127025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1374|TWO_SIDED|95.0|-0.115|0.016|||Mixed Models Analysis|||Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.||0.016|-0.115|0.1374
91616904|NCT02364947|183127026|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.031||0.0348|TWO_SIDED|95.0|-0.127|-0.005|||Mixed Models Analysis|||||-0.005|-0.127|0.0348
91616905|NCT02364947|183127026|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.034||0.1444|TWO_SIDED|95.0|-0.116|0.017|||Mixed Models Analysis|||||0.017|-0.116|0.1444
91616906|NCT02702518|183127044|OTHER||||||<|0.001||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||<0.001
91657207|NCT00324168|183207958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.53|TWO_SIDED|95.0|-0.1|0.2|||Regression, Linear|||0-1.90 mm||0.20|-0.10|0.53
91657208|NCT00324168|183207958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.95|TWO_SIDED|95.0|-0.15|0.16|||Regression, Linear|||1.91-2.70 mm||0.16|-0.15|0.95
91657209|NCT00324168|183207958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.7|TWO_SIDED|95.0|-0.12|0.18|||Regression, Linear|||2.71-4.06 mm||0.18|-0.12|0.70
91712511|NCT04878055|183316761|SUPERIORITY|||||||0.593|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to HD - Please note that the number of subjects in this analysis is not 270, but it is 144||||0.593
91712512|NCT04878055|183316761|SUPERIORITY|||||||0.54|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 60 - Please note that the number of subjects in this analysis is not 270, but it is 3||||0.540
91657210|NCT00324168|183207958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||4.07-8.90 mm||0.01|-0.31|0.07
91657211|NCT01682083|183207968|SUPERIORITY|Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.47|||<|0.0001|TWO_SIDED|95.0|0.39|0.58|||Log Rank|||The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.||0.58|0.39|< 0.0001
91712513|NCT04878055|183316761|SUPERIORITY|||||||0.224|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to EOS - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.224
91712514|NCT04878055|183316762|SUPERIORITY|||||||0.68|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 3 - Please note that the number of subjects in this analysis is not 270, but it is 15||||0.68
91657212|NCT01682083|183207969|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with dabrafenib + trametinib compared with Placebo.|Hazard Ratio, log|0.57||||0.006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|the two-sided threshold for significance at this first interim analysis was p=0.000019||Hazard ratio is obtained from the stratified Pike estimator.||0.79|0.42|0.006
91657213|NCT01682083|183207970|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.51|||||TWO_SIDED|95.0|0.4|0.65||||||Hazard ratio is estimated using Pike estimator.||0.65|0.40|
91657214|NCT01682083|183207971|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.39|0.57||||||Hazard ratio is estimated using Pike estimator.||0.57|0.39|
91657215|NCT02731157|183207972|OTHER||Mean Difference (Final Values)|0.65||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
91657216|NCT01014728|183207978|SUPERIORITY_OR_OTHER|||||||0.937||95.0|||||t-test, 2 sided|||||||0.937
91712515|NCT04878055|183316762|SUPERIORITY|||||||0.272||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 7 - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.272
91616907|NCT02702518|183127044|OTHER|||||||0.2324||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining data at week 8 was compared with data at baseline to determine significant change.||||0.2324
91616908|NCT02702518|183127045|OTHER|||||||0.001||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||0.001
91616909|NCT02702518|183127045|OTHER|||||||0.2257||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI data at week 8 was compared with data at baseline to determine significant change.||||0.2257
91616910|NCT02658994|183127065|SUPERIORITY||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.33|0.07||||||||0.07|-0.33|
91616911|NCT02658994|183127066|SUPERIORITY||Median Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-1.39|1.19||||||||1.19|-1.39|
91616912|NCT02658994|183127067|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.33|0.09||||||||0.09|-0.33|
91616913|NCT02658994|183127068|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.19|0.96||||||Child Bayley scaled receptive score||0.96|-0.19|
91616914|NCT02658994|183127068|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.83|0.9||||||Child Bayley scaled fine motor score||0.90|-0.83|
91616915|NCT02658994|183127069|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.43|1.05||||||||1.05|0.43|
91616916|NCT02658994|183127070|SUPERIORITY||Risk Ratio (RR)|-0.09|||||TWO_SIDED|95.0|-0.32|0.15||||||Length-for-age z-scores||0.15|-0.32|
91616917|NCT02658994|183127070|SUPERIORITY||Risk Ratio (RR)|-0.12|||||TWO_SIDED|95.0|-0.33|0.1||||||Weight-for-age z-scores||0.10|-0.33|
91616918|NCT00262080|183127071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||95.0||||no adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|non-parametric Wilcoxon Rank Sum test|||The primary efficacy analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.037
91616919|NCT00262080|183127072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Wilcoxon Rank Sum Test.|||The analysis compared the change from baseline in MSCS score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.044
91616920|NCT00262080|183127076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||The Log-Rank test was used to compare the time distribution between the two treatment groups.||||0.055
91712516|NCT04878055|183316762|SUPERIORITY|||||||1||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 14 - Please note that the number of subjects in this analysis is not 270, but it is 13||||1.000
91712517|NCT04878055|183316762|SUPERIORITY|||||||0.903||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 21 - Please note that the number of subjects in this analysis is not 270, but it is 9||||0.903
91524341|NCT01114204|182923911|NON_INFERIORITY|The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.|Treatment Difference|2.58||||0.2833|TWO_SIDED|95.0|-3.89|9.06|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information."||9.06|-3.89|0.2833
91616921|NCT01725152|183127089|SUPERIORITY|||||||0.4475|||||||Linear mixed-effect|||Null hypothesis of no treatment difference in CGI-I will be assessed using a linear mixed-effects model for repeated measures, accounting for treatment (ganaxolone versus placebo) and period at a significant level of 0.05. A sample size of 30 participants in each arm/group was planned in the study will have 90% power to detect a modest effect size of 0.6 at level 0.05 in CGI-I. With a possible dropout rate of 15%, the power for testing the effect size becomes 84%.||||0.4475
91616922|NCT01111539|183127107|SUPERIORITY||Treatment Difference|-1.0|||=|0.644|TWO_SIDED|95.0|-5.2|3.3|||ANCOVA|||The statistical analyses was performed by fitting an analysis of covariance (ANCOVA) model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model included baseline MADRS Total Score as a covariate and treatment as the main effect.||3.3|-5.2|=0.644
91616923|NCT01111539|183127107|SUPERIORITY||Treatment Difference|-3.7|||=|0.08|TWO_SIDED|95.0|-7.8|0.4|||ANCOVA|||The statistical analyses will be performed by fitting an ANCOVA model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model will include baseline MADRS Total Score as a covariate and treatment as the main effect.||0.4|-7.8|=0.080
91616924|NCT01111539|183127108|SUPERIORITY||Treatment Difference|-0.3|||=|0.366|TWO_SIDED|95.0|-0.8|0.3|||Cochran-Mantel-Haenszel|||||0.3|-0.8|=0.366
91616925|NCT01111539|183127108|SUPERIORITY||Treatment Difference|-0.4|||=|0.138|TWO_SIDED|95.0|-0.9|0.1|||Cochran-Mantel-Haenszel|||||0.1|-0.9|=0.138
91616926|NCT01111539|183127109|SUPERIORITY||Treatment Difference|0.0|||=|0.995|TWO_SIDED|95.0|-1.2|1.2|||ANCOVA|||||1.2|-1.2|=0.995
91616927|NCT01111539|183127109|SUPERIORITY||Treatment Difference|-0.9|||=|0.118|TWO_SIDED|95.0|-2.1|0.2|||ANCOVA|||||0.2|-2.1|=0.118
91657217|NCT01014728|183207979|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91657218|NCT01014728|183207980|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.461
91657219|NCT03657160|183207981|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.27|0.73|||Log Rank|||||0.73|0.27|<0.001
91657220|NCT03657160|183207982|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.86|||Log Rank|||||0.86|0.37|0.0043
91657221|NCT03657160|183207983|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0204|TWO_SIDED|95.0|0.39|0.91|||Log Rank|||||0.91|0.39|0.0204
91657222|NCT03657160|183207984|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0668|TWO_SIDED|95.0|0.22|1.04|||Log Rank|||||1.04|0.22|0.0668
91657223|NCT03657160|183207985|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.1458|TWO_SIDED|95.0|0.34|1.17|||Log Rank|||||1.17|0.34|0.1458
91657224|NCT03657160|183207986|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0105|TWO_SIDED|95.0|0.46|0.91|||Log Rank|||||0.91|0.46|0.0105
91657225|NCT00686959|183207996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.831|TWO_SIDED|95.0|0.79|1.2|||Log Rank|||||1.20|0.79|0.831
91657226|NCT00686959|183207997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Log Rank|||||1.04|0.71|0.130
91657227|NCT00686959|183207998|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED||||||Log Rank|||||||0.458
91657228|NCT00686959|183208001|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Fisher Exact|||Relapsed within the radiation treatment field||||0.132
91657229|NCT00686959|183208001|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED||||||Fisher Exact|||Relapsed inside thorax, outside of radiation field||||0.337
91657230|NCT00686959|183208001|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||Fisher Exact|||Relapsed distant disease||||0.457
91657231|NCT00686959|183208002|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Fisher Exact|||||||0.150
91657232|NCT02724800|183208039|NON_INFERIORITY|non-inferiority margin = 3.43|Mean Difference (Net)|2.2|||<|0.05|TWO_SIDED|95.0|-0.9|5.6||a priori|Mixed Models Analysis|||||5.6|-0.9|<0.05
91657233|NCT02724800|183208046|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91657234|NCT02724800|183208049|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91657235|NCT00262964|183208054|SUPERIORITY_OR_OTHER||||||<|0.019||95.0|||||t-test, 2 sided|||null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects||||<0.019
91657236|NCT00262964|183208055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was P\<0.05.|t-test, 2 sided|||null hypothesis was that VLDL-TG production would not differ between the two groups.||||<0.001
91657237|NCT00262964|183208056|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|||null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.||||<0.001
91657238|NCT00262964|183208057|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.||||<0.002
91657239|NCT00262964|183208058|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||Student's t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.||||.301
91712518|NCT04878055|183316762|SUPERIORITY|||||||0.432||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to EOT - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.432
91712519|NCT04878055|183316762|SUPERIORITY|||||||0.105||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 28 - Please note that the number of subjects in this analysis is not 270, but it is 6||||0.105
91657240|NCT00262964|183208058|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||A Student's t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.||||.315
91712520|NCT04878055|183316762|SUPERIORITY|||||||0.551||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to HD - Please note that the number of subjects in this analysis is not 270, but it is 8||||0.551
91712521|NCT04878055|183316763|SUPERIORITY||Odds Ratio (OR)|0.52||||0.232|TWO_SIDED|95.0|0.178|1.522||Analysis is based on logistic regression model with proportion of patients died up to Day 60 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Regression, Logistic|||up to day 60||1.522|0.178|0.232
91712522|NCT04878055|183316763|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Day 90 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Odds Ratio (OR)|0.246||||0.158|TWO_SIDED|95.0|0.034|1.782|||Regression, Logistic|||Up to Day 90||1.782|0.034|0.158
91712523|NCT04878055|183316764|SUPERIORITY|Freedom from (time to) death or respiratory failure (need of invasive mechanical ventilation or ECMO or admission to ICU linked to worsening of respiratory parameters compared to baseline) up to Day 90 was performed using the same Kaplan-Meier analysis and the one-sided log-rank test that were used to test for differences between groups||||||0.33607|||||||Log Rank|||||||0.33607
91712524|NCT01004978|183316785|SUPERIORITY|||||||0.4||||||one-sided p-value|Cochran-Mantel-Haenszel|||||||0.4
91712525|NCT01004978|183316786|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
91712526|NCT00814138|183316795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-488.0||||0.26|TWO_SIDED|95.0|-2443.4|1467.3|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||1467.3|-2443.4|0.26
91712527|NCT00814138|183316796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.26|TWO_SIDED|95.0|-9.7|5.8|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.8|-9.7|0.26
91657241|NCT00262964|183208059|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||a Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.||||0.708
91712528|NCT00814138|183316797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.29|TWO_SIDED|95.0|-4.9|1.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.5|-4.9|0.29
91657242|NCT00262964|183208059|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||A Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.||||.022
91712529|NCT00814138|183316798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.28|TWO_SIDED|95.0|-6.3|1.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.8|-6.3|0.28
91712530|NCT00814138|183316799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.82|TWO_SIDED|95.0|-7.2|5.4|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.4|-7.2|0.82
91712531|NCT00814138|183316800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.21|TWO_SIDED|95.0|-3.7|0.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.8|-3.7|0.21
91712532|NCT00814138|183316801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.09|TWO_SIDED|95.0|-7.1|0.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.5|-7.1|0.09
91712533|NCT02372344|183316810|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.77|0.54|
91712534|NCT02372344|183316810|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.86|0.59|
91712535|NCT02372344|183316811|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.35|||||TWO_SIDED|95.0|0.27|0.47||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.47|0.27|
91712536|NCT02372344|183316811|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.44|||||TWO_SIDED|95.0|0.33|0.59||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.59|0.33|
91712537|NCT02372344|183316811|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.46|||||TWO_SIDED|95.0|0.36|0.57||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.57|0.36|
91657243|NCT00262964|183208060|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate||||.020
91657244|NCT00262964|183208060|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||a priori threshold for significance was \<0.05.|t-test, 2 sided|||the null hypothesis was that niacin would not change the VLDL-Tg clearance rate||||.358
91657245|NCT00262964|183208061|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.||||0.758
91657246|NCT00262964|183208061|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||the a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that niacin would not effect VLDL-Tg production rates.||||.023
91657247|NCT00262964|183208062|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||the a priori threshold for statistical significance was p \<0.05|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.024
91657248|NCT00262964|183208062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||the a priori threshold for statistical significance was p\<0.05|t-test, 2 sided|||The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||<0.001
91657249|NCT00262964|183208063|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.||||.768
91657250|NCT00262964|183208063|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin||||.019
91657251|NCT00262964|183208064|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.||||.318
91657252|NCT00262964|183208064|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.||||.025
91657253|NCT00262964|183208065|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.419
91657254|NCT00262964|183208065|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||.018
91657255|NCT01041781|183208072|SUPERIORITY||Hazard Ratio (HR)|1.076||||0.5346|TWO_SIDED|95.0|0.853|1.367|||Log Rank|||||1.367|0.853|0.5346
91657256|NCT01041781|183208076|SUPERIORITY|||||||0.0049|||||||Log Rank|||||||0.0049
91657257|NCT01041781|183208077|SUPERIORITY|||||||0.0131|||||||Log Rank|||||||0.0131
91657258|NCT01041781|183208078|SUPERIORITY|||||||0.0322|||||||Log Rank|||||||0.0322
91657259|NCT04646109|183208094|SUPERIORITY|||||||0.43||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.43
91657260|NCT04646109|183208095|SUPERIORITY|||||||0.14||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.14
91657261|NCT04646109|183208096|SUPERIORITY|||||||0.68||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.68
91657262|NCT04646109|183208097|SUPERIORITY|||||||0.15||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.15
91657263|NCT04646109|183208098|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.37
91657264|NCT04646109|183208099|SUPERIORITY|||||||0.12||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.12
91657265|NCT04646109|183208100|SUPERIORITY|||||||0.22||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.22
91657266|NCT04646109|183208103|SUPERIORITY|||||||0.1||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.10
91657267|NCT04646109|183208104|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.37
91657268|NCT04646109|183208105|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
91657269|NCT04646109|183208106|SUPERIORITY|||||||0.39||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.39
91657270|NCT04646109|183208107|SUPERIORITY|||||||0.24||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.24
91657271|NCT04646109|183208108|SUPERIORITY|||||||0.56||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.56
91657272|NCT04646109|183208109|SUPERIORITY|||||||0.005||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.005
91657273|NCT04646109|183208110|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
91657274|NCT04646109|183208111|SUPERIORITY|||||||0.01||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.01
91657275|NCT06176768|183208113|SUPERIORITY||Odds Ratio (OR)|3.4||||0.316|TWO_SIDED|95.0|0.3|40.4|||Cochran-Mantel-Haenszel|||||40.4|0.3|0.316
91657276|NCT06176768|183208114|SUPERIORITY||Least square mean difference|-6.77|STANDARD_ERROR_OF_MEAN|4.63||0.175|TWO_SIDED|95.0|-17.15|3.6|||Mixed Model Repeated Measures Analysis|||||3.60|-17.15|0.175
91657277|NCT06176768|183208115|SUPERIORITY||Least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|2.27||0.311|TWO_SIDED|95.0|-7.06|2.35|||Mixed Model Repeated Measures Analysis|||||2.35|-7.06|0.311
91657278|NCT02672553|183208124|SUPERIORITY||Median Difference (Final Values)|-12.5|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91657279|NCT02672553|183208125|SUPERIORITY||Median Difference (Final Values)|-10.5||||0.2077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2077
91791382|NCT03720652|183460441|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91791383|NCT03720652|183460441|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91616928|NCT03007485|183127110|SUPERIORITY||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||Reported p-value was calculated|t-test, 2 sided|||Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.|"The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge (binary: yes/no). Logistic regression was used to compare the primary outcome in terms of the OR of event rates between the 2 arms, in 3 sets of models (per each of the 3 aforementioned level of analyses):~* Model 1: Treatment arm only with no other covariates added to the model~* Model 2: Treatment arm, adjusted for race and clinical site (stratification variables)~* Model 3: Treatment arm, adjusted for race, clinical site, and risk factors reported in the literature to be associated with the primary outcome, for explanatory purposes To examine the role of adherence on the primary outcome, we included adherence as a binary variable and as a continuous variable (percentage of sessions attended) in the 3 models."|||<.05
91616929|NCT01848054|183127115|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
91616930|NCT01848054|183127122|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
91657280|NCT01606306|183208157|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Rank-ordered logistic regression (ROLR) was used to model the probability of best response for each treatment and bootstrapping was used to calculate confidence intervals.|rank-order logistic regression|ROLR is in the class of Discrete Choice models, which seek to estimate the probability that an individual responds best to a specific treatments.||The primary analysis tested the null hypothesis of all three treatments having equal probability to yield the best response as defined by the criteria defining the primary outcome. A sample size of 300 participants was selected to test the primary null hypothesis of all three treatments having equal probability (one-third) to yield the best response with statistical power of at least 0.90 if any one of the three treatments actually has probability of at least one-half to yield the best response.|The probabilistic construct of the Discrete Choice (DC) model does not reflect individual behavior that is intrinsically probabilistic, but rather population heterogeneity. DC models rely on stochastic assumptions to account for unobserved factors related to the treatments themselves and to characteristics of study participants. Specifically, that each treatment has an underlying utility that may differ from one individual to another. Mathematically, these utilities are represented by U\_t, where t denotes the treatment. Utility can be thought of as a latent variable quantifying treatment response where higher values indicate better response. The U\_t can be used to find the probability (P) of best response for each treatment by the following equation: P\_t = exp(U\_t) / \[exp(U\_A) + exp(U\_B) + exp(U\_C)\], where A, B, and C, denote the three study treatments. The primary analysis tested whether the three treatments have equal utility and, thus, equal probability of best response.|||<0.0001
91657281|NCT00970281|183208162|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was based on an analysis of variance (ANOVA) model that included treatment and site as a factor.|ANOVA|||Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.||||<0.001
91657282|NCT00970281|183208163|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||This is the p-value for 0.25 hour after first IM injection.|ANOVA|||||||0.009
91657283|NCT00970281|183208163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 0.50 hour after first IM injection.|ANOVA|||||||<0.001
91657284|NCT00970281|183208163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1 hour after first IM injection.|ANOVA|||||||<0.001
91657285|NCT00970281|183208163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1.5 hour after first IM injection.|ANOVA|||||||<0.001
91657286|NCT00970281|183208164|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
91657287|NCT00970281|183208165|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
91657288|NCT00970281|183208166|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||This is the p-value for the 0.5 hour after the first IM injection.|Fisher Exact|||||||0.167
91657289|NCT00970281|183208166|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||This is the p-value for the 1 hour after the first IM injection.|Fisher Exact|||||||0.134
91657290|NCT00970281|183208166|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 1.5 hour after the first IM injection.|Fisher Exact|||||||0.008
91791384|NCT03720652|183460442|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.046|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.046
91616931|NCT02808312|183127125|OTHER|Two-sided 90% Confidence Intervals (CIs) were calculated for the ratios of geometric least-squares means (GLSMs) of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7869|||||TWO_SIDED|90.0|1.2885|2.4781||||||An analysis of variance (ANOVA) model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||2.4781|1.2885|
91616932|NCT02808312|183127125|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4868|||||TWO_SIDED|90.0|1.6735|3.6954||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||3.6954|1.6735|
91657291|NCT00970281|183208166|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 2 hours after the first IM injection.|Fisher Exact|||||||0.008
91657292|NCT00970281|183208166|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||This is the p-value for the 24 hours after the first IM injection.|Fisher Exact|||||||0.204
91712538|NCT02372344|183316811|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.57|||||TWO_SIDED|95.0|0.45|0.71||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.71|0.45|
91712539|NCT02372344|183316812|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.56|||||TWO_SIDED|95.0|0.45|0.69||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.45|
91712540|NCT02372344|183316812|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.55||||||95.0|0.44|0.69||||||Total EPA: Ratio of Before Meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.44|
91712541|NCT02372344|183316812|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.04|0.73|
91712542|NCT02372344|183316812|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.02|0.72|
91712543|NCT00249873|183316864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0133||95.0|0.81|0.98||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.|||0.98|0.81|0.0133
91712544|NCT00249873|183316865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.001||95.0|0.62|0.83||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.|||0.83|0.62|<0.001
91712545|NCT00249873|183316866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.696||95.0|0.89|1.08||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.|||1.08|0.89|0.696
91712546|NCT00249873|183316867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91616933|NCT02808312|183127125|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.324|||||TWO_SIDED|90.0|4.3675|9.1569||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||9.1569|4.3675|
91657293|NCT00970281|183208167|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the p-value for Parkinsonism.|Fisher Exact|||||||1.000
91657294|NCT00159965|183208168|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.673|STANDARD_ERROR_OF_MEAN|0.369||0.29|TWO_SIDED|95.0|-0.051|1.396|||Overdispersed Poisson Regression|||Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||1.396|-0.051|0.29
91712547|NCT02762084|183316884|OTHER|Pairwise comparison||||||0.03|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.030
91712548|NCT02762084|183316884|OTHER|Pairwise comparison||||||0.756|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.756
91712549|NCT02762084|183316885|OTHER|Pairwise comparison||||||0.5|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.500
91712550|NCT02762084|183316885|OTHER|Pairwise comparison||||||0.681|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.681
91712551|NCT02762084|183316889|OTHER|One-sided comparison||||||0.048|||||||Mann Whitey U|||at Week 26||||0.048
91712552|NCT02762084|183316889|OTHER|Two-sided comparison||||||0.096|||||||Mann Whitey U|||at Week 26||||0.096
91712553|NCT02762084|183316890|OTHER|Two-sided comparison||||||0.008|||||||Mann Whitey U|||at Week 26||||0.008
91657295|NCT00159965|183208168|SUPERIORITY_OR_OTHER||Risk Ratio, log|-0.598|STANDARD_ERROR_OF_MEAN|0.276||0.03|TWO_SIDED|95.0|-1.139|-0.073|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||-0.073|-1.139|0.03
91657296|NCT00159965|183208168|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.077|STANDARD_ERROR_OF_MEAN|0.252||0.78|TWO_SIDED|95.0|-0.431|0.571|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.||0.571|-0.431|0.78
91712554|NCT01096160|183316920|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-7.08||||0.1194|TWO_SIDED|90.0|-17.1|2.92|||Linear mixed effects model|||||2.92|-17.1|0.1194
91712555|NCT01096160|183316920|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-13.1||||0.0224|TWO_SIDED|90.0|-23.7|-2.48|||Linear mixed effects model|||||-2.48|-23.7|0.0224
91712556|NCT01096160|183316920|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|0.33||||0.4791|TWO_SIDED|90.0|-10.3|10.91|||Linear mixed effects model|||||10.91|-10.3|0.4791
91712557|NCT01096160|183316920|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-8.21||||0.0705|TWO_SIDED|90.0|-17.4|1.01|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.01|-17.4|0.0705
91712558|NCT01096160|183316921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|3.85||||0.1161|TWO_SIDED|90.0|-1.51|9.22|||Linear mixed effects model|||||9.22|-1.51|0.1161
91712559|NCT01096160|183316921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|7.28||||0.0189|TWO_SIDED|90.0|1.6|12.97|||Linear mixed effects model|||||12.97|1.60|0.0189
91712560|NCT01096160|183316921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|0.26||||0.4689|TWO_SIDED|90.0|-5.42|5.95|||Linear mixed effects model|||||5.95|-5.42|0.4689
91712561|NCT01096160|183316921|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|4.06||||0.0869|TWO_SIDED|90.0|-0.89|9.01|||Linear mixed effects model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||9.01|-0.89|0.0869
91712562|NCT01096160|183316922|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-9.87||||0.003|TWO_SIDED|90.0|-15.7|-4.09|||Linear mixed effects model|||||-4.09|-15.7|0.003
91712563|NCT01096160|183316922|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-11.2||||0.002|TWO_SIDED|90.0|-17.3|-5.1|||Linear mixed effects model|||||-5.10|-17.3|0.002
91712564|NCT01096160|183316922|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-5.18||||0.08|TWO_SIDED|90.0|-11.3|0.95|||Linear mixed effcts model|||||0.95|-11.3|0.080
91712565|NCT01096160|183316922|OTHER|Difference in change from baseline in AIx (TWA\^0-24hrs)|Mean Difference (Final Values)|-6.79||||0.019|TWO_SIDED|90.0|-12.1|-1.46|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||-1.46|-12.1|0.019
91712566|NCT01096160|183316923|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.28||||0.318|TWO_SIDED|90.0|0.53|3.05|||Linear mixed effects model|||||3.05|0.53|0.318
91712567|NCT01096160|183316923|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.66||||0.17|TWO_SIDED|90.0|0.66|4.17|||Linear mixed effects model|||||4.17|0.66|0.17
91712568|NCT01096160|183316923|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.41||||0.054|TWO_SIDED|90.0|0.16|1.02|||Linear mixed effcts model|||||1.02|0.16|0.054
91712569|NCT01096160|183316923|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.78||||0.297|TWO_SIDED|90.0|0.35|1.73|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.73|0.35|0.297
91712570|NCT02028507|183316955|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.003|TWO_SIDED|95.0|0.55|0.89|||Regression, Cox|||This statistical Analysis corresponds to Global health status/quality of life scale||0.89|0.55|0.003
91712571|NCT02028507|183316955|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.5|0.76|||Regression, Cox|||This statistical Analysis corresponds to Physical functioning scale||0.76|0.50|<0.001
91712572|NCT02028507|183316955|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.51|0.79|||Regression, Cox|||This statistical Analysis corresponds to Role functioning scale||0.79|0.51|<0.001
91712573|NCT02028507|183316955|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.818|TWO_SIDED|95.0|0.76|1.25|||Regression, Cox|||This statistical Analysis corresponds to Emotional functioning scale||1.25|0.76|0.818
91712574|NCT02028507|183316955|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004|TWO_SIDED|95.0|0.54|0.89|||Regression, Cox|||This statistical Analysis corresponds to Cognitive functioning scale||0.89|0.54|0.004
91712575|NCT02028507|183316955|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78|||Regression, Cox|||This Statistical Analysis corresponds to Social functioning scale||0.78|0.49|<0.001
91712576|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.57|0.86|||Regression, Cox|||This Statistical Analysis corresponds to Fatigue scale||0.86|0.57|0.001
91712577|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.76|||Regression, Cox|||This Statistical Analysis corresponds to Nausea and vomiting scale||0.76|0.45|<0.001
91712578|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.042|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||This Statistical Analysis corresponds to Pain scale||0.99|0.62|0.042
91657297|NCT00159965|183208169|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657298|NCT00159965|183208170|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657299|NCT00159965|183208171|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657300|NCT00159965|183208172|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91712579|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.599|TWO_SIDED|95.0|0.81|1.44|||Regression, Cox|||This Statistical Analysis corresponds to Dyspnea scale||1.44|0.81|0.599
91712580|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.196|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||This Statistical Analysis corresponds to Insomnia scale||1.10|0.64|0.196
91712581|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.011|TWO_SIDED|95.0|0.54|0.92|||Regression, Cox|||This Statistical Analysis corresponds to Appetite loss scale||0.92|0.54|0.011
91712582|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.564|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||This Statistical Analysis corresponds to Constipation scale||1.41|0.83|0.564
91712583|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Cox|||This Statistical Analysis corresponds to Diarrhea scale||0.55|0.32|<0.001
91712584|NCT02028507|183316956|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.118|TWO_SIDED|95.0|0.56|1.07|||Regression, Cox|||This Statistical Analysis corresponds to Financial difficulties scale||1.07|0.56|0.118
91712585|NCT02028507|183316957|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.659|TWO_SIDED|95.0|0.74|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Body image scale||1.21|0.74|0.659
91712586|NCT02028507|183316957|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.74|1.39|||Regression, Cox|||This Statistical Analysis corresponds to Future perspective scale||1.39|0.74|0.928
91712587|NCT02028507|183316958|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.029|TWO_SIDED|95.0|0.64|0.98|||Regression, Cox|||This Statistical Analysis corresponds to Systemic side-effects scale||0.98|0.64|0.029
91712588|NCT02028507|183316958|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.571|TWO_SIDED|95.0|0.71|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Breast symptoms scale||1.21|0.71|0.571
91712589|NCT02028507|183316958|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.187|TWO_SIDED|95.0|0.66|1.09|||Regression, Cox|||This Statistical Analysis corresponds to Arm symptoms scale||1.09|0.66|0.187
91712590|NCT03361306|183316959|SUPERIORITY|Assuming the true VGPR+ rate is 40% under the null hypothesis, then this design will provide 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. For the originally planned enrollment of 40 subjects, if at least 21 subjects achieved VGPR or better to induction, the null hypothesis would be rejected.|Response Rate|0.467||||0.39|TWO_SIDED|95.0|0.213|0.734||This p-value is only based on partial enrollment on the study. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.734|0.213|0.390
91712591|NCT01556932|183316966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.2541|||TWO_SIDED|||||||||||||
91712592|NCT02038179|183316970|SUPERIORITY|||||||0.83||||||Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.|paired t-test|||||||0.83
91712593|NCT02038179|183316971|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91712594|NCT02038179|183316972|SUPERIORITY|||||||0.84|||||||paired t-test|||||||0.84
91712595|NCT04767373|183316980|OTHER||Efficacy estimate|60.4|||<|0.001|TWO_SIDED|95.0|44.1|71.9|||Exact method|One-sided p-value was estimated using an exact method.|A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- Relative Risk \[RR\]) \& 95% confidence interval (CI). The model included region, gestational age, and age at randomization as covariates.|||71.9|44.1|<0.001
91712596|NCT04767373|183316981|OTHER||Estimated Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.5|||||Estimated percentage difference beteween Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.5|-2.6|
91712597|NCT04767373|183316982|OTHER||Estimated Percentage Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.0|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||-0.0|-1.4|
91712598|NCT04767373|183316983|OTHER||Estimated Percentage Difference|-1.8|||||TWO_SIDED|95.0|-5.0|1.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.2|-5.0|
91712599|NCT04767373|183316984|OTHER||Estimated Percentage Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.2|-0.3|
91712600|NCT04767373|183316985|OTHER||Estimated Percentage Difference|0.1|||||TWO_SIDED|95.0|-0.4|0.5|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.5|-0.4|
91712601|NCT04767373|183316988|OTHER||Efficacy estimate|84.2|||<|0.001|TWO_SIDED|95.0|66.6|92.6||One-sided p-value was estimated using an exact method.|Exact method||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||92.6|66.6|<0.001
91712602|NCT04767373|183316989|OTHER||Efficacy estimate|59.5|||||TWO_SIDED|95.0|43.3|71.1|||||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||71.1|43.3|
91712603|NCT04346199|183317014|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.758|||||TWO_SIDED|95.0|0.323|1.722||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.722|0.323|
91712604|NCT04346199|183317022|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.967||||||95.0|0.69|1.353|||Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.353|0.690|
91712605|NCT00099632|183317031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV||||0.37
91712606|NCT00099632|183317031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV||||0.091
91712607|NCT03131687|183317036|OTHER||Posterior Mean Difference|-1.0|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712608|NCT03131687|183317036|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712609|NCT03131687|183317036|OTHER||Posterior Mean Difference|-1.83|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712610|NCT03131687|183317036|OTHER||Posterior Mean Difference|-1.89|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712611|NCT03131687|183317037|OTHER||Posterior Mean Difference|-0.89|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712612|NCT03131687|183317037|OTHER||Posterior Mean Difference|-1.49|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712613|NCT03131687|183317037|OTHER||Posterior Mean Difference|-1.62|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712614|NCT03131687|183317037|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
91712615|NCT03131687|183317038|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Models Analysis|||||-0.4|-1.2|<0.001
91712616|NCT03131687|183317038|OTHER||Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||||-1.3|-2.2|<0.001
91712617|NCT03131687|183317038|OTHER||Median Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.5|-1.6|||Mixed Models Analysis|||||-1.6|-2.5|<0.001
91712618|NCT03131687|183317038|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-2.9|-2.0|||Mixed Models Analysis|||||-2.0|-2.9|<0.001
91712619|NCT03131687|183317039|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
91712620|NCT03131687|183317039|OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.0|-1.3|||Mixed Models Analysis|||||-1.3|-2.0|<0.001
91712621|NCT03131687|183317039|OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.3|-1.5|||Mixed Models Analysis|||||-1.5|-2.3|<0.001
91712622|NCT03131687|183317039|OTHER||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.4|-1.7|||Mixed Models Analysis|||||-1.7|-2.4|<0.001
91712623|NCT03131687|183317040|OTHER||Mean Difference (Final Values)|-0.5||||0.655|TWO_SIDED|95.0|-2.7|1.7|||Mixed Models Analysis|||||1.7|-2.7|0.655
91712624|NCT03131687|183317040|OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.6|-2.3|||Mixed Models Analysis|||||-2.3|-6.6|<0.001
91712625|NCT03131687|183317040|OTHER||Mean Difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-10.5|-6.0|||Mixed Models Analysis|||||-6.0|-10.5|<0.001
91712626|NCT03131687|183317040|OTHER||Median Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-13.3|-8.6|||Mixed Models Analysis|||||-8.6|-13.3|<0.001
91712627|NCT03131687|183317041|OTHER|||||||0.053|||||||Regression, Logistic|||||||0.053
91712628|NCT03131687|183317041|OTHER|||||||0.002|||||||Regression, Logistic|||||||0.002
91712629|NCT03131687|183317041|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712630|NCT03131687|183317041|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712631|NCT03131687|183317042|OTHER|||||||0.193|||||||Regression, Logistic|||||||0.193
91712632|NCT03131687|183317042|OTHER|||||||0.036|||||||Regression, Logistic|||||||0.036
91712633|NCT03131687|183317042|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
91712634|NCT03131687|183317042|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
91712635|NCT03131687|183317043|OTHER|||||||0.03|||||||Regression, Logistic|||||||0.030
91712636|NCT03131687|183317043|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712637|NCT03131687|183317043|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712638|NCT03131687|183317043|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712639|NCT03131687|183317044|OTHER|||||||0.008|||||||Regression, Logistic|||||||0.008
91712640|NCT03131687|183317044|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712641|NCT03131687|183317044|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712642|NCT03131687|183317044|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91712643|NCT03131687|183317045|OTHER||Mean Difference (Final Values)|-22.4||||0.01|TWO_SIDED|95.0|-39.4|-5.3|||Mixed Models Analysis|||||-5.3|-39.4|0.010
91712644|NCT03131687|183317045|OTHER||Mean Difference (Final Values)|-56.2|||<|0.001|TWO_SIDED|95.0|-72.9|-39.5|||Mixed Models Analysis|||||-39.5|-72.9|<0.001
91712645|NCT03131687|183317045|OTHER||Odds Ratio (OR)|-76.3|||<|0.001|TWO_SIDED|95.0|-93.3|-59.2|||Mixed Models Analysis|||||-59.2|-93.3|<0.001
91616934|NCT02808312|183127126|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7628|||||TWO_SIDED|90.0|1.275|2.4374||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||2.4374|1.2750|
91616935|NCT02808312|183127126|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4559|||||TWO_SIDED|90.0|1.6531|3.6486||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||3.6486|1.6531|
91616936|NCT02808312|183127126|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.2497|||||TWO_SIDED|90.0|4.2965|9.091||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||9.0910|4.2965|
91616937|NCT02808312|183127127|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.5703|||||TWO_SIDED|90.0|1.0723|2.2995||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.2995|1.0723|
91657301|NCT00159965|183208173|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91616938|NCT02808312|183127127|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7343|||||TWO_SIDED|90.0|1.2193|2.4667||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.4667|1.2193|
91616939|NCT02808312|183127127|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.5369|||||TWO_SIDED|90.0|1.7562|3.6648||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||3.6648|1.7562|
91616940|NCT02808312|183127138|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8722|||||TWO_SIDED|90.0|0.6827|1.1144||||||||1.1144|0.6827|
91616941|NCT02808312|183127138|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0731|||||TWO_SIDED|90.0|0.8295|1.3883||||||||1.3883|0.8295|
91616942|NCT02808312|183127138|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1475|||||TWO_SIDED|90.0|0.8783|1.4992||||||||1.4992|0.8783|
91616943|NCT02808312|183127139|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8188|||||TWO_SIDED|90.0|0.5837|1.1486||||||||1.1486|0.5837|
91616944|NCT02808312|183127139|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1323|||||TWO_SIDED|90.0|0.8772|1.4615||||||||1.4615|0.8772|
91616945|NCT02808312|183127139|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3563|||||TWO_SIDED|90.0|1.0468|1.7574||||||||1.7574|1.0468|
91657302|NCT00159965|183208174|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657303|NCT00159965|183208175|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657304|NCT00159965|183208176|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657305|NCT00159965|183208177|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657306|NCT00159965|183208178|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657307|NCT00159965|183208179|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657308|NCT00159965|183208180|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657309|NCT00159965|183208181|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91657310|NCT01993875|183208191|SUPERIORITY|||||||0.129||||||Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
91657311|NCT01993875|183208192|SUPERIORITY|||||||0.129||||||Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
91657312|NCT01993875|183208193|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
91657313|NCT01993875|183208194|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
91657314|NCT01993875|183208195|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.|ANCOVA|||||||0.0664
91657315|NCT01993875|183208196|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.|ANCOVA|||||||0.0664
91712646|NCT03131687|183317045|OTHER||Mean Difference (Final Values)|-73.0|||<|0.001|TWO_SIDED|95.0|-90.9|-55.2|||Mixed Models Analysis|||||-55.2|-90.9|<0.001
91712647|NCT03131687|183317046|OTHER||Mean Difference (Final Values)|0.0||||0.396|TWO_SIDED|95.0|-0.1|0.0|||Mixed Models Analysis|||||0.0|-0.1|0.396
91712648|NCT03131687|183317046|OTHER||Mean Difference (Final Values)|0.0||||0.903|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.903
91712649|NCT03131687|183317046|OTHER||Mean Difference (Final Values)|0.0||||0.536|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.536
91712650|NCT03131687|183317046|OTHER||Mean Difference (Final Values)|0.0||||0.325|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||||0.1|-0.0|0.325
91712651|NCT03131687|183317047|OTHER||Mean Difference (Final Values)|-0.1||||0.565|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||||0.2|-0.4|0.565
91712652|NCT03131687|183317047|OTHER||Mean Difference (Final Values)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Models Analysis|||||-0.1|-0.7|0.010
91712653|NCT03131687|183317047|OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
91712654|NCT03131687|183317047|OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis|||||-0.3|-0.9|<0.001
91712655|NCT03131687|183317048|OTHER||Mean Difference (Final Values)|-0.3||||0.164|TWO_SIDED|95.0|-0.7|0.1|||Mixed Models Analysis|||||0.1|-0.7|0.164
91712656|NCT03131687|183317048|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
91712657|NCT03131687|183317048|OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||||-0.6|-1.4|<0.001
91712658|NCT03131687|183317048|OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||||-0.7|-1.5|<0.001
91712659|NCT03131687|183317049|OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.919
91712660|NCT03131687|183317049|OTHER||Mean Difference (Final Values)|-0.2||||0.194|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.194
91712661|NCT03131687|183317049|OTHER||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.145
91712662|NCT03131687|183317049|OTHER||Mean Difference (Final Values)|-0.3||||0.067|TWO_SIDED|95.0|-0.6|0.0|||Mixed Models Analysis|||||0.0|-0.6|0.067
91712663|NCT03131687|183317050|OTHER||Mean Difference (Final Values)|-0.7||||0.539|TWO_SIDED|95.0|-3.1|1.6|||Mixed Models Analysis|||||1.6|-3.1|0.539
91712664|NCT03131687|183317050|OTHER||Mean Difference (Final Values)|-3.8||||0.001|TWO_SIDED|95.0|-6.1|-1.5|||Mixed Models Analysis|||||-1.5|-6.1|0.001
91712665|NCT03131687|183317050|OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.7|||Mixed Models Analysis|||||-3.7|-8.4|<0.001
91712666|NCT03131687|183317050|OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.3|-6.4|||Mixed Models Analysis|||||-6.4|-11.3|<0.001
91712667|NCT02137226|183317053|NON_INFERIORITY_OR_EQUIVALENCE|The 90% Confidence Interval (CI) for ACR20 at Week 12, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-12.0%, 15.0%\]|Difference in proportions|5.9|||||TWO_SIDED|90.0|-0.9|12.7|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 12 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.7|-0.9|
91712668|NCT02137226|183317054|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.25|0.05|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 12 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.05|-0.25|
91712669|NCT02137226|183317054|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.23|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 24 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.23|-0.17|
91722423|NCT04390750|183337442|OTHER|The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 1 and Control at 3 months.|Interaction coefficient|0.0||||0.939|TWO_SIDED|95.0|-0.11|0.11|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the primary endpoint of 3 months.||0.11|-0.11|0.939
91712670|NCT02137226|183317056|NON_INFERIORITY_OR_EQUIVALENCE|The 95% Confidence Interval (CI) for ACR20 at Week 24, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-15.0%;+15.0%\]|Difference in proportions|4.5|||||TWO_SIDED|95.0|-3.4|12.5|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 24 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.5|-3.4|
91712671|NCT00672633|183317096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.52||95.0|||||ANOVA|Repeated measures||The study was designed with 80% power to detect a net improvement of Triglyceride elevles with a sample size of 60.||||0.52
91616946|NCT02808312|183127140|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0658|||||TWO_SIDED|90.0|0.8275|1.3726||||||||1.3726|0.8275|
91712672|NCT00672633|183317097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.06||95.0|||||ANOVA|Repeated Measures||No power calculations done for this outcomes||||0.06
91712673|NCT00672633|183317098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3||||0.27||95.0|||||ANOVA|Repeated Measures||No power calculations were conducted for this outcome||||0.27
91712674|NCT01868165|183317102|OTHER||Slope|0.58|||||TWO_SIDED|95.0|-0.6|1.77|||||"Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).~Multiple adjustments including; age, sex, education."|||1.77|-0.60|
91712675|NCT01603407|183317113|SUPERIORITY|||||||0.3904|||||||Mixed Models Analysis|||||||0.3904
91712676|NCT01603407|183317113|SUPERIORITY|||||||0.569|||||||Mixed Models Analysis|||||||0.5690
91524342|NCT00991341|182923919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.44|TWO_SIDED|95.0|-0.6|0.26|||ANCOVA|The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.|||0.26|-0.60|0.44
91657316|NCT02937701|183208219|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.37|||||TWO_SIDED|90.0|2.67|15.96||||||For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).||15.96|2.67|
91712677|NCT01603407|183317113|SUPERIORITY|||||||0.1518|||||||Mixed Models Analysis|||||||0.1518
91712678|NCT01603407|183317114|SUPERIORITY|||||||0.7365|||||||Mixed Models Analysis|||||||0.7365
91712679|NCT01603407|183317114|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91712680|NCT01603407|183317114|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91712681|NCT01603407|183317115|SUPERIORITY|||||||0.2456|||||||Mixed Models Analysis|||||||0.2456
91616947|NCT02808312|183127140|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.2942|||||TWO_SIDED|90.0|0.9663|1.7334||||||||1.7334|0.9663|
91712682|NCT01603407|183317115|SUPERIORITY|||||||0.0369|||||||Mixed Models Analysis|||||||0.0369
91616948|NCT02808312|183127140|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8225|||||TWO_SIDED|90.0|0.5479|1.2347||||||||1.2347|0.5479|
91712683|NCT01603407|183317115|SUPERIORITY|||||||0.3589|||||||Mixed Models Analysis|||||||0.3589
91712684|NCT01603407|183317116|SUPERIORITY|||||||0.7335|||||||Mixed Models Analysis|||||||0.7335
91712685|NCT01603407|183317116|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
91712686|NCT01603407|183317116|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
91712687|NCT01603407|183317117|SUPERIORITY|||||||0.9532|||||||Mixed Models Analysis|||||||0.9532
91712688|NCT01603407|183317117|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.0040
91712689|NCT01603407|183317117|SUPERIORITY|||||||0.0046|||||||Mixed Models Analysis|||||||0.0046
91712690|NCT01603407|183317118|SUPERIORITY|||||||0.332|||||||Mixed Models Analysis|||||||0.3320
91712691|NCT01603407|183317118|SUPERIORITY|||||||0.1248|||||||Mixed Models Analysis|||||||0.1248
91712692|NCT01603407|183317118|SUPERIORITY|||||||0.5854|||||||Mixed Models Analysis|||||||0.5854
91712693|NCT01603407|183317119|SUPERIORITY|||||||0.30814|||||||Mixed Models Analysis|||||||0.30814
91712694|NCT01603407|183317119|SUPERIORITY|||||||0.1405|||||||Mixed Models Analysis|||||||0.1405
91712695|NCT01603407|183317119|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.6640
91712696|NCT01603407|183317121|SUPERIORITY|||||||0.8345|||||||Mixed Models Analysis|||||||0.8345
91712697|NCT01603407|183317121|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
91712698|NCT01603407|183317121|SUPERIORITY|||||||0.5059|||||||Mixed Models Analysis|||||||0.5059
91712699|NCT01603407|183317122|SUPERIORITY|||||||0.5947|||||||Mixed Models Analysis|||||||0.5947
91712700|NCT01603407|183317122|SUPERIORITY|||||||0.1098|||||||Mixed Models Analysis|||||||0.1098
91712701|NCT01603407|183317122|SUPERIORITY|||||||0.2803|||||||Mixed Models Analysis|||||||0.2803
91712702|NCT01603407|183317123|SUPERIORITY|||||||0.3875|||||||Mixed Models Analysis|||||||0.3875
91712703|NCT01603407|183317123|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.4240
91712704|NCT01603407|183317123|SUPERIORITY|||||||0.9683|||||||Mixed Models Analysis|||||||0.9683
91712705|NCT01603407|183317124|SUPERIORITY|||||||0.6161|||||||Mixed Models Analysis|||||||0.6161
91712706|NCT01603407|183317124|SUPERIORITY|||||||0.7302|||||||Mixed Models Analysis|||||||0.7302
91712707|NCT01603407|183317124|SUPERIORITY|||||||0.9007|||||||Mixed Models Analysis|||||||0.9007
91712708|NCT01603407|183317125|SUPERIORITY|||||||0.8138|||||||Mixed Models Analysis|||||||0.8138
91712709|NCT01603407|183317125|SUPERIORITY|||||||0.5995|||||||Mixed Models Analysis|||||||0.5995
91712710|NCT01603407|183317125|SUPERIORITY|||||||0.7616|||||||Mixed Models Analysis|||||||0.7616
91657317|NCT02937701|183208219|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.3|||||TWO_SIDED|90.0|2.67|15.92|||||Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.|A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.||15.92|2.67|
91657318|NCT02937701|183208219|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|7.184|||||TWO_SIDED|90.0|0.748|13.62|||||The ACR core set includes tender joint count, swollen joint count, subject's global health assessment, investigator's global health assessment, subject's assessment of disease related pain, HAQ-DI, and CRP.|A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).||13.620|0.748|
91657319|NCT02937701|183208220|OTHER||Response Difference|8.03|||||TWO_SIDED|90.0|1.15|14.81||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||14.81|1.15|
91657320|NCT02937701|183208220|OTHER||Response Difference|4.96|||||TWO_SIDED|90.0|-1.8|11.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.64|-1.80|
91657321|NCT02937701|183208220|OTHER||Response Difference|9.37|||||TWO_SIDED|90.0|-0.51|12.87||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.87|-0.51|
91657322|NCT02937701|183208221|OTHER||Response Difference|3.05|||||TWO_SIDED|90.0|-5.26|11.73||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.73|-5.26|
91657323|NCT02937701|183208221|OTHER||Response Difference|8.5|||||TWO_SIDED|90.0|-1.18|17.97||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.97|-1.18|
91657324|NCT02937701|183208221|OTHER||Response Difference|3.31|||||TWO_SIDED|90.0|-4.61|11.7||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.70|-4.61|
91657325|NCT02937701|183208221|OTHER||Response Difference|4.06|||||TWO_SIDED|90.0|-5.4|13.4||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.40|-5.40|
91657326|NCT02937701|183208221|OTHER||Response Difference|0.82|||||TWO_SIDED|90.0|-7.34|9.4||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.40|-7.34|
91657327|NCT02937701|183208221|OTHER||Response Difference|2.79|||||TWO_SIDED|90.0|-6.86|12.34||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.34|-6.86|
91657328|NCT02937701|183208221|OTHER||Response Difference|-3.74|||||TWO_SIDED|90.0|-12.27|5.17||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||5.17|-12.27|
91657329|NCT02937701|183208221|OTHER||Response Difference|1.12|||||TWO_SIDED|90.0|-8.89|11.08||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.08|-8.89|
91657330|NCT02937701|183208221|OTHER||Response Difference|-5.25|||||TWO_SIDED|90.0|-13.24|3.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.29|-13.24|
91657331|NCT02937701|183208221|OTHER||Response Difference|-1.49|||||TWO_SIDED|90.0|-11.01|8.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.04|-11.01|
91712711|NCT01603407|183317126|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.6800
91712712|NCT01603407|183317126|SUPERIORITY|||||||0.4365|||||||Mixed Models Analysis|||||||0.4365
91712713|NCT01603407|183317126|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
91524343|NCT00991341|182923920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5|TWO_SIDED|95.0|0.48|1.43|||Regression, Cox|The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.|The longer storage duration arm is the reference category.|||1.43|0.48|0.50
91524344|NCT00991341|182923921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2|TWO_SIDED|95.0|-0.82|0.17|||ANCOVA|The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.|||0.17|-0.82|0.20
91524345|NCT00991341|182923922|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.018||||0.5|TWO_SIDED|95.0|-0.033|0.069|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.069|-0.033|0.50
91524346|NCT00991341|182923923|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.4|TWO_SIDED|95.0|-0.09|0.035|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.035|-0.090|0.40
91524347|NCT00991341|182923924|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.41|TWO_SIDED|95.0|-0.059|0.023|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.023|-0.059|0.41
91524348|NCT00991341|182923925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.75|TWO_SIDED|95.0|-0.62|0.37|||Kruskal-Wallis|||||0.37|-0.62|0.75
91616949|NCT02808312|183127141|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0806|||||TWO_SIDED|90.0|0.791|1.4762||||||||1.4762|0.7910|
91524349|NCT00991341|182923926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.62|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.|||0.05|-0.08|0.62
91524350|NCT00991341|182923927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.93||||0.35|TWO_SIDED|95.0|-2.11|5.98||The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.|ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.|Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.||5.98|-2.11|0.35
91524351|NCT00991341|182923928|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Kruskal-Wallis|||||||0.10
91524352|NCT00991341|182923929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|||<|0.01|TWO_SIDED|95.0|-0.89|-0.41|||ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.|||-0.41|-0.89|<0.01
91524353|NCT00991341|182923931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.98|1.25||The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.|Regression, Cox||The longer storage duration arm is reference category.|||1.25|0.98|0.11
91524354|NCT00991341|182923932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.22|TWO_SIDED|95.0|0.96|1.22|||Regression, Cox|The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.|The longer storage duration arm is reference category.|||1.22|0.96|0.22
91524355|NCT00991341|182923933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.71|TWO_SIDED|95.0|-0.59|1.0|||Kruskal-Wallis||The longer storage duration arm is reference category.|||1.00|-0.59|0.71
91524356|NCT00991341|182923934|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.53|TWO_SIDED|95.0|-0.057|0.027|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.027|-0.057|0.53
91524357|NCT02799472|182923973|OTHER||Ratio|14.201|||<|0.001|TWO_SIDED|95.0|6.251|32.262|||Repeated measures analysis|||GM-CSF - Complex, Week 1||32.262|6.251|<0.001
91616950|NCT02808312|183127141|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3729|||||TWO_SIDED|90.0|0.9663|1.9506||||||||1.9506|0.9663|
91616951|NCT02808312|183127141|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.903|||||TWO_SIDED|90.0|0.6142|1.3275||||||||1.3275|0.6142|
91616952|NCT03628417|183127142|NON_INFERIORITY|Examined the objective response rate (ORR) that there was 20% difference between the 2 treatment arms at day 180. With a significance level of 0,05 and a power of 80% the study required 28 evaluable metastases.|Odds Ratio (OR)|0.4489629||||0.3|TWO_SIDED|95.0|-13.3|53.3|||Fisher Exact|||After reviewing existing data from electrochemotherapy with intratumoral bleomycin on small cutaneous metastases ≤3cm , we estimated the expected response rate for electrochemotherapy to 85%. We have no clinical results for the treatment of calcium electroporation, but on the basis of preclinical studies, we decided to accept a difference in response of 20%. All statistical analysis were done using IBM SPSS v24.||53.30|-13.30|0.30
91616953|NCT02420223|183127145|SUPERIORITY|||||||0.017|||||||Regression, Logistic|||||||.017
91616954|NCT02420223|183127145|SUPERIORITY|||||||0.337|||||||Regression, Logistic|||||||0.337
91616955|NCT02420223|183127148|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91616956|NCT02420223|183127149|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91616957|NCT02420223|183127150|SUPERIORITY|||||||0.06|||||||Likelihood ration Chi-Square test|||||||0.06
91616958|NCT01826422|183127156|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
91616959|NCT01826422|183127157|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
91712714|NCT01603407|183317127|SUPERIORITY||Mean Difference (Net)|-1.545||||0.0041|TWO_SIDED|98.3|-2.6611|-0.2479|||Mixed Models Analysis|||||-0.2479|-2.6611|0.0041
91712715|NCT01603407|183317127|SUPERIORITY||Mean Difference (Net)|0.9076||||0.9076|TWO_SIDED|98.3|-1.248|1.1331|||Mixed Models Analysis|||||1.1331|-1.248|0.9076
91712716|NCT01603407|183317127|SUPERIORITY||Mean Difference (Net)|1.3971||||0.0054|TWO_SIDED|98.3|0.2014|2.5927|||Mixed Models Analysis|||||2.5927|0.2014|0.0054
91712717|NCT01603407|183317128|SUPERIORITY||Mean Difference (Net)|-1.48|||<|0.0001|TWO_SIDED|98.3|-2.3242|-0.6358|||Mixed Models Analysis|||||-0.6358|-2.3242|<0.0001
91712718|NCT01603407|183317128|SUPERIORITY||Mean Difference (Net)|3.054|||<|0.0001|TWO_SIDED|98.3|2.2222|3.8857|||Mixed Models Analysis|||||3.8857|2.2222|<0.0001
91712719|NCT01603407|183317128|SUPERIORITY||Mean Difference (Net)|4.534|||<|0.0001|TWO_SIDED|98.3|3.6941|5.3738|||Mixed Models Analysis|||||5.3738|3.6941|<0.0001
91712720|NCT01603407|183317129|SUPERIORITY||Mean Difference (Net)|-0.6205||||0.0853|TWO_SIDED|98.3|-1.4845|0.2434|||Mixed Models Analysis|||||0.2434|-1.4845|0.0853
91657332|NCT02937701|183208222|OTHER||Response Difference|4.41|||||TWO_SIDED|90.0|-0.56|9.38||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.38|-0.56|
91712721|NCT01603407|183317129|SUPERIORITY||Mean Difference (Net)|-0.876||||0.0143|TWO_SIDED|98.3|-1.7292|-0.0229|||Mixed Models Analysis|||||-0.0229|-1.7292|0.0143
91712722|NCT01603407|183317129|SUPERIORITY||Mean Difference (Net)|-0.2555||||0.4731|TWO_SIDED|98.3|-1.1117|0.6007|||Mixed Models Analysis|||||0.6007|-1.1117|0.4731
91712723|NCT02358031|183317130|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21211|TWO_SIDED|95.0|0.78|1.11||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.11|0.78|0.21211
91712724|NCT02358031|183317131|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03697|TWO_SIDED|95.0|0.69|1.02||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.02|0.69|0.03697
91712725|NCT02358031|183317132|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.02951|TWO_SIDED|95.0|0.58|1.01||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.01|0.58|0.02951
91712726|NCT02358031|183317133|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00025|TWO_SIDED|95.0|0.6|0.87||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.87|0.60|0.00025
91712727|NCT02358031|183317134|SUPERIORITY||Hazard Ratio (HR)|0.65||||2e-05|TWO_SIDED|95.0|0.53|0.8||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.80|0.53|0.00002
91616960|NCT01826422|183127158|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
91657333|NCT02937701|183208222|OTHER||Response Difference|1.62|||||TWO_SIDED|90.0|-4.71|7.94||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.94|-4.71|
91657334|NCT02937701|183208222|OTHER||Response Difference|2.3|||||TWO_SIDED|90.0|-4.45|9.03||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.03|-4.45|
91657335|NCT02937701|183208222|OTHER||Response Difference|7.09|||||TWO_SIDED|90.0|0.27|13.83||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.83|0.27|
91712728|NCT02358031|183317135|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.00044|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.82|0.45|0.00044
91791385|NCT03720652|183460442|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.14
91616961|NCT01826422|183127159|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
91616962|NCT01826422|183127160|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
91616963|NCT01826422|183127161|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
91712729|NCT02358031|183317136|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.9983|TWO_SIDED|95.0|1.09|1.53||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.53|1.09|0.99830
91712730|NCT02358031|183317137|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.8958|TWO_SIDED|95.0|0.94|1.36||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.36|0.94|0.89580
91712731|NCT02358031|183317138|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.46791|TWO_SIDED|95.0|0.76|1.29||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.29|0.76|0.46791
91712732|NCT02358031|183317139|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.01985|TWO_SIDED|95.0|0.7|0.99||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.99|0.70|0.01985
91712733|NCT02358031|183317140|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00133|TWO_SIDED|95.0|0.61|0.9||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.90|0.61|0.00133
91712734|NCT02358031|183317141|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0001|TWO_SIDED|95.0|0.44|0.78||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.78|0.44|0.00010
91712735|NCT02358031|183317148|OTHER||Difference in ORR Percentage|-0.8||||0.574|TWO_SIDED|95.0|-8.7|7.2||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||7.2|-8.7|0.5740
91712736|NCT02358031|183317149|OTHER||Difference in ORR Percentage|0.5||||0.4586|TWO_SIDED|95.0|-8.2|9.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||9.1|-8.2|0.4586
91712737|NCT02358031|183317150|OTHER||Difference in ORR Percentage|5.0||||0.2161|TWO_SIDED|95.0|-7.5|17.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||17.4|-7.5|0.2161
91712738|NCT02358031|183317151|OTHER||Difference in LS Means|0.4||||0.839|TWO_SIDED|95.0|-3.46|4.26||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||4.26|-3.46|0.839
91712739|NCT02358031|183317152|OTHER||Hazard Ratio (HR)|1.37||||0.9497|TWO_SIDED|95.0|0.94|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.94|0.9497
91712740|NCT02358031|183317153|OTHER||Hazard Ratio (HR)|1.37||||0.9476|TWO_SIDED|95.0|0.93|2.02||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.02|0.93|0.9476
91712741|NCT02358031|183317154|OTHER||Hazard Ratio (HR)|1.05||||0.5836|TWO_SIDED|95.0|0.69|1.59||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.59|0.69|0.5836
91791386|NCT03720652|183460442|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.058
91616964|NCT01826422|183127162|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
91616965|NCT01826422|183127163|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
91616966|NCT01826422|183127164|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
91616967|NCT01826422|183127165|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
91616968|NCT01826422|183127166|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
91616969|NCT01826422|183127167|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||0.05
91616970|NCT01826422|183127168|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
91616971|NCT01826422|183127169|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
91616972|NCT01826422|183127170|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
91616973|NCT01826422|183127171|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
91657336|NCT02937701|183208223|OTHER||Response Difference|-1.33|||||TWO_SIDED|90.0|-10.4|7.62||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.62|-10.40|
91616974|NCT01826422|183127172|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
91616975|NCT01826422|183127173|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||0.05
91616976|NCT01826422|183127174|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
91616977|NCT01826422|183127175|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
91616978|NCT04716933|183127227|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.48|0.97||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||0.97|0.48|
91616979|NCT04716933|183127228|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.12||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||1.12|0.54|
91616980|NCT04716933|183127229|OTHER||Percent Difference|11.3|||||TWO_SIDED|95.0|-2.0|24.2||||||Comparision based on unstratified Miettinen \& Nurminen method||24.2|-2.0|
91616981|NCT01071044|183127252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANOVA|These data were initially analyzed with a one-way ANOVA.||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||.005
91616982|NCT01071044|183127253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.008
91616983|NCT01071044|183127254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.183
91616984|NCT01071044|183127255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.046
91616985|NCT01071044|183127256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.219
91616986|NCT01071044|183127257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.038
91616987|NCT01071044|183127258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.022
91616988|NCT02913222|183127282|OTHER|||||||1||||||The threshold for statistical significance was set at p = 0.05.|Fisher Exact|||A priori criteria for success was that we would achieve 90% adherence to attending treatment sessions. Fisher's exact test compared patient adherence to treatment session rates by site and by group.||||1.0
91616989|NCT02913222|183127283|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-2.2||||0.32|TWO_SIDED|95.0|-6.51|2.11||The threshold for statistical significance was p = 0.05|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||2.11|-6.51|0.32
91616990|NCT02913222|183127284|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-5.55||||0.14|TWO_SIDED|95.0|-13.1|1.99||The threshold for statistical significance was p = 0.05.|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||1.99|-13.10|0.14
91616991|NCT01201798|183127332|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.||0.09|-0.53|
91616992|NCT04891770|183127359|OTHER||percentage difference|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||For Cohort 2A versus Cohort 2B, the percentage difference and the corresponding 95% confidence interval was calculated using the stratum-adjusted Mantel-Haenszel method, stratified by HBsAg group (\> 3 and ≤ 3 log10 IU/mL).|||7.3|-2.3|
91616993|NCT01052012|183127395|SUPERIORITY||LS Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.597||0.1473|TWO_SIDED|95.0|-2.11|0.33|||ANCOVA|With pooled site and treatment group as factors and incision length as a covariate.||||0.33|-2.11|0.1473
91616994|NCT01052012|183127395|SUPERIORITY||LS Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.547||0.0601|TWO_SIDED|95.0|-2.16|0.05|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.05|-2.16|0.0601
91616995|NCT01052012|183127395|SUPERIORITY||LS Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.233||0.1483|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.12|-0.80|0.1483
91616996|NCT01052012|183127396|SUPERIORITY||Median Difference (Hodge-Lehmann)|-1.0||||0.9901|TWO_SIDED|95.0|-54.5|52.0|||Wilcoxon (Mann-Whitney)|||||52.0|-54.5|0.9901
91791387|NCT03720652|183460443|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91616997|NCT01052012|183127396|SUPERIORITY||Median Difference (Hodge-Lehmann)|-5.0||||0.201|TWO_SIDED|95.0|-14.0|3.4|||Wilcoxon Rank-Sum|||||3.4|-14.0|0.2010
91657337|NCT02937701|183208223|OTHER||Response Difference|3.24|||||TWO_SIDED|90.0|-7.28|13.67||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.67|-7.28|
91657338|NCT02937701|183208223|OTHER||Response Difference|6.52|||||TWO_SIDED|90.0|-2.62|15.48||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||15.48|-2.62|
91616998|NCT01052012|183127396|SUPERIORITY||Median Difference (Hodge-Lehmann)|-3.0||||0.5897|TWO_SIDED|95.0|-15.0|8.0|||Wilcoxon Rank-Sum|||||8.0|-15.0|0.5897
91616999|NCT01617434|183127422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|||<|0.0001||95.0|-1.39|-0.99|||Mixed Models Analysis|||The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.||-0.99|-1.39|<0.0001
91617000|NCT01617434|183127423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001||95.0|-1.7|-0.86|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-0.86|-1.70|<0.0001
91617001|NCT01617434|183127424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001||95.0|-2.01|-1.18|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-1.18|-2.01|<0.0001
91617002|NCT01617434|183127425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|||<|0.0001||95.0|-3.85|-2.37|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-2.37|-3.85|<0.0001
91617003|NCT01617434|183127426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.91|||<|0.0001||95.0|5.45|14.59|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||14.59|5.45|<0.0001
91617004|NCT01617434|183127427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.12|||<|0.0001||95.0|9.92|40.84|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||40.84|9.92|<0.0001
91617005|NCT02993224|183127431|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.75|0.89|||McNemar|||Preference for deferasirox DT vs deferasirox FCT||0.89|0.75|<.0001
91617006|NCT02993224|183127432|SUPERIORITY||Difference of proportion|0.78|||<|0.0001|TWO_SIDED|95.0|0.65|0.88|||McNemar|||Preference of deferasirox FCT vs deferasirox DT||0.88|0.65|<0.0001
91617007|NCT02993224|183127432|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.71|0.91|||McNemar|||Preference for deferasirox FCT vs previous iron chelation therapy||0.91|0.71|<0.0001
91524358|NCT02799472|182923973|OTHER||Ratio|32.36|||<|0.001|TWO_SIDED|95.0|15.828|66.156|||Repeated measures analysis|||GM-CSF - Complex, Week 2||66.156|15.828|<0.001
91524359|NCT02799472|182923973|OTHER||Ratio|55.772|||<|0.001|TWO_SIDED|95.0|25.646|121.287|||Repeated measures analysis|||GM-CSF - Complex, Week 4||121.287|25.646|<0.001
91524360|NCT02799472|182923973|OTHER||Ratio|48.336|||<|0.001|TWO_SIDED|95.0|19.341|120.798|||Repeated measures analysis|||GM-CSF - Complex, Week 6||120.798|19.341|<0.001
91524361|NCT02799472|182923973|OTHER||Ratio|34.635|||<|0.001|TWO_SIDED|95.0|13.69|87.629|||Repeated measures analysis|||GM-CSF - Complex, Week 8||87.629|13.690|<0.001
91524362|NCT02799472|182923973|OTHER||Ratio|23.249|||<|0.001|TWO_SIDED|95.0|8.579|63.005|||Repeated measures analysis|||GM-CSF - Complex, Week 12||63.005|8.579|<0.001
91657339|NCT02937701|183208223|OTHER||Response Difference|10.74|||||TWO_SIDED|90.0|0.12|21.03||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||21.03|0.12|
91712742|NCT02358031|183317161|OTHER||Difference in ORR Percentage|-19.0||||1|TWO_SIDED|95.0|-25.8|-12.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).||-12.1|-25.8|1.0000
91791388|NCT03720652|183460443|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91524363|NCT02799472|182923973|OTHER||Ratio|1.233||||0.401|TWO_SIDED|95.0|0.742|2.048|||Repeated measures analysis|||GM-CSF - Complex, 12-Week FU||2.048|0.742|0.401
91657340|NCT02937701|183208223|OTHER||Response Difference|0.56|||||TWO_SIDED|90.0|-8.54|9.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.59|-8.54|
91791389|NCT03720652|183460443|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
91791390|NCT00167778|183460457|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
91524364|NCT02799472|182923974|OTHER||Ratio|0.943||||0.193|TWO_SIDED|95.0|0.861|1.032|||Repeated measures analysis|||14-3-3 ETA Protein, Week 1||1.032|0.861|0.193
91524365|NCT02799472|182923974|OTHER||Ratio|1.028||||0.842|TWO_SIDED|95.0|0.776|1.362|||Repeated measures analysis|||14-3-3 ETA Protein, Week 2||1.362|0.776|0.842
91524366|NCT02799472|182923974|OTHER||Ratio|0.743||||0.127|TWO_SIDED|95.0|0.505|1.093|||Repeated measures analysis|||14-3-3 ETA Protein, Week 4||1.093|0.505|0.127
91524367|NCT02799472|182923974|OTHER||Ratio|0.762||||0.137|TWO_SIDED|95.0|0.531|1.095|||Repeated measures analysis|||14-3-3 ETA Protein, Week 6||1.095|0.531|0.137
91524368|NCT02799472|182923974|OTHER||Ratio|0.886||||0.488|TWO_SIDED|95.0|0.623|1.259|||Repeated measures analysis|||14-3-3 ETA Protein, Week 8||1.259|0.623|0.488
91524369|NCT02799472|182923974|OTHER||Ratio|0.793||||0.338|TWO_SIDED|95.0|0.488|1.29|||Repeated measures analysis|||14-3-3 ETA Protein, Week 12||1.290|0.488|0.338
91524370|NCT02799472|182923974|OTHER||Ratio|0.859||||0.582|TWO_SIDED|95.0|0.491|1.502|||Repeated measures analysis|||14-3-3 ETA Protein, 12-Week FU||1.502|0.491|0.582
91524371|NCT02799472|182923974|OTHER||Ratio|0.999||||0.996|TWO_SIDED|95.0|0.699|1.427|||Repeated measures analysis|||S100 CBP A8 and A9, Week 1||1.427|0.699|0.996
91791391|NCT00167778|183460458|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
91791392|NCT00167778|183460459|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
91791393|NCT00167778|183460460|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
91791394|NCT00167778|183460461|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
91791395|NCT00167778|183460463|SUPERIORITY_OR_OTHER||||||=|0.8||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.8
91791396|NCT00167778|183460464|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
91791397|NCT00167778|183460465|SUPERIORITY_OR_OTHER||||||=|0.4||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=.4
91791398|NCT00167778|183460466|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
91791399|NCT00167778|183460467|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
91791400|NCT00167778|183460468|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
91791401|NCT00167778|183460469|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
91791402|NCT00167778|183460470|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
91617008|NCT02993224|183127433|SUPERIORITY||Difference of proportion|0.66|||<|0.0001|TWO_SIDED|95.0|0.51|0.77|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 4||0.77|0.51|< 0.0001
91722424|NCT04390750|183337442|OTHER|The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 2 and Control at 3 months.|Interaction coefficient|-0.09||||0.103|TWO_SIDED|95.0|-0.21|0.02|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the primary endpoint of 3 months.||0.02|-0.21|0.103
91524372|NCT02799472|182923974|OTHER||Ratio|0.944||||0.745|TWO_SIDED|95.0|0.662|1.346|||Repeated measures analysis|||S100 CBP A8 and A9, Week 2||1.346|0.662|0.745
91617009|NCT02993224|183127433|SUPERIORITY||Difference of proportion|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 24||0.72|0.44|< 0.0001
91791403|NCT00167778|183460471|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
91617010|NCT02993224|183127435|SUPERIORITY||Least squares mean|-3.6|STANDARD_ERROR_OF_MEAN|2.3||0.1191|TWO_SIDED|95.0|-8.1|0.9|||ANCOVA|||Compliance of deferasirox DT vs deferasirox FCT||0.9|-8.1|0.1191
91617011|NCT02915367|183127448|OTHER|Pearson chi-square||||||0.93|||||||Chi-squared|||||||0.93
91617012|NCT02915367|183127450|OTHER|Pearson chi-square||||||0.96|||||||Chi-squared|||||||0.96
91791404|NCT00167778|183460472|SUPERIORITY_OR_OTHER||||||=|0.13||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoon paired signed rank test for the differences between Rigid and Torsion Adapter pylons||||||=0.13
91791405|NCT00167778|183460473|SUPERIORITY_OR_OTHER||||||=|0.92||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between Rigid and Torsion Adapter pylons.||||||=0.92
91791406|NCT00167778|183460474|SUPERIORITY_OR_OTHER||||||=|0.37||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.37
91791407|NCT00167778|183460475|SUPERIORITY_OR_OTHER||||||=|0.27||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.27
91791408|NCT00167778|183460476|SUPERIORITY_OR_OTHER||||||=|0.2||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.20
91791409|NCT00167778|183460477|SUPERIORITY_OR_OTHER||||||=|0.59||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.59
91791410|NCT00167778|183460478|SUPERIORITY_OR_OTHER||||||=|0.057||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.057
91791411|NCT00167778|183460479|SUPERIORITY_OR_OTHER||||||=|0.78||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.78
91791412|NCT02519855|183460502|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported a conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.95|||Longitudinal regression model|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||0.95|0.80|<0.001
91791413|NCT02519855|183460503|SUPERIORITY_OR_OTHER||GMFR from Baseline|1.9|||<|0.001|TWO_SIDED|95.0|1.76|2.05||A lower bound of the 95% CI on the GMFR \> 1.4 indicated that the Concomitant Group induces an acceptable VZV antibody response. A p-value ≤0.025 also supported this conclusion.|Longitudinal regression||Estimated GMFR, 95% CI and p-value were based on a longitudinal regression model adjusting for age.|||2.05|1.76|<0.001
91791414|NCT02519855|183460504|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.18|0.88|<0.001
91791415|NCT02519855|183460505|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.1|||<|0.001|TWO_SIDED|95.0|0.94|1.29|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.29|0.94|<0.001
91791416|NCT02519855|183460506|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.14|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.14|0.88|<0.001
91791417|NCT02519855|183460507|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.99|||<|0.001|TWO_SIDED|95.0|0.87|1.13|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.13|0.87|<0.001
91791418|NCT01842633|183460508|SUPERIORITY_OR_OTHER||Treatment Difference|-0.47|||||TWO_SIDED|95.0|-1.36|0.42||||||||0.42|-1.36|
91791419|NCT02093351|183460522|EQUIVALENCE|If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.06|1.22|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.22|1.06|
91657341|NCT02937701|183208223|OTHER||Response Difference|2.93|||||TWO_SIDED|90.0|-7.62|13.39||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.39|-7.62|
91657342|NCT02937701|183208223|OTHER||Response Difference|-1.04|||||TWO_SIDED|90.0|-10.11|7.93||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.93|-10.11|
91791420|NCT02093351|183460523|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.71|0.9|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.90|0.71|
91791421|NCT02093351|183460524|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|Geometric Least Squares (GLS) Mean Ratio|0.9|||||TWO_SIDED|90.0|0.84|0.97|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.97|0.84|
91791422|NCT02093351|183460525|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.84|1.04|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.04|0.84|
91791423|NCT02093351|183460526|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.98|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.98|0.91|
91791424|NCT02093351|183460527|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.21|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters||1.21|0.99|
91791425|NCT02093351|183460528|EQUIVALENCE|If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.16|||||TWO_SIDED|90.0|1.11|1.21|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.21|1.11|
91791426|NCT02093351|183460529|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.73|||||TWO_SIDED|90.0|0.63|0.84|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.84|0.63|
91791427|NCT02093351|183460530|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|GLS Mean Ratio|0.86|||||TWO_SIDED|90.0|0.8|0.93|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.93|0.80|
91791428|NCT02093351|183460531|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.76|1.05|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.05|0.76|
91791429|NCT02093351|183460532|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.95|||||TWO_SIDED|90.0|0.91|0.99|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.99|0.91|
91791430|NCT02093351|183460533|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.15|||||TWO_SIDED|90.0|1.07|1.25|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters.||1.25|1.07|
91791431|NCT01099709|183460536|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||108.51|101.06|
91791432|NCT01099709|183460536|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||108.51|101.06|
91791433|NCT01099709|183460537|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.6|||||TWO_SIDED|90.0|93.73|97.53|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.53|93.73|
91791434|NCT01099709|183460538|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric test/Ref Ratio x 100|95.7|||||TWO_SIDED|90.0|93.85|97.68|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.68|93.85|
91791435|NCT00706849|183460539|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 treatment groups.||||<0.001
91791436|NCT00706849|183460541|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91791437|NCT00706849|183460543|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91617013|NCT00088634|183127464|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
91617014|NCT00088634|183127465|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
91657343|NCT02937701|183208223|OTHER||Response Difference|6.14|||||TWO_SIDED|90.0|-4.44|16.54||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||16.54|-4.44|
91657344|NCT02937701|183208223|OTHER||Response Difference|-5.43|||||TWO_SIDED|90.0|-14.39|3.71||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.71|-14.39|
91617015|NCT00088634|183127466|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
91617016|NCT00088634|183127467|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
91617017|NCT02426658|183127468|SUPERIORITY|||||||0.7044|||||||Mixed Models Analysis|||||||0.7044
91617018|NCT03255291|183127473|SUPERIORITY|A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0288|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition||||0.0288
91617019|NCT03255291|183127473|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.3329|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.||||0.3329
91617020|NCT03255291|183127473|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0215|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior||||0.0215
91617021|NCT03255291|183127474|SUPERIORITY|||||||0.0333||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||-This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons.||||0.0333
91617022|NCT03255291|183127475|SUPERIORITY|||||||0.4946||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.4946
91617023|NCT03255291|183127476|SUPERIORITY|||||||0.1397|||||||ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.1397
91617024|NCT03255291|183127477|SUPERIORITY|||||||0.007||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.0070
91617025|NCT03255291|183127478|SUPERIORITY|||||||0.8793||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.8793
91617026|NCT03255291|183127479|SUPERIORITY|||||||0.4673||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.4673
91657345|NCT02937701|183208223|OTHER||Response Difference|2.98|||||TWO_SIDED|90.0|-7.51|13.37||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.37|-7.51|
91791438|NCT00706849|183460545|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91617027|NCT03255291|183127480|SUPERIORITY|||||||0.1916||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1916
91617028|NCT03255291|183127481|SUPERIORITY|||||||0.8661||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.8661
91657346|NCT02937701|183208224|OTHER||Response Difference|-2.5|||||TWO_SIDED|90.0|-5.84|0.83||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||0.83|-5.84|
91617029|NCT03255291|183127482|SUPERIORITY|||||||0.0711||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0711
91617030|NCT03255291|183127483|SUPERIORITY|||||||0.0365||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0365
91617031|NCT03255291|183127484|SUPERIORITY|||||||0.1511||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1511
91617032|NCT03050359|183127485|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.4|||||TWO_SIDED|95.0|-2.998|3.791||||||||3.791|-2.998|
91791439|NCT00706849|183460547|SUPERIORITY_OR_OTHER|||||||0.042||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.042
91791440|NCT00706849|183460549|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
91791441|NCT00706849|183460551|SUPERIORITY_OR_OTHER|||||||0.023||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.023
91791442|NCT00706849|183460553|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
91791443|NCT00706849|183460555|SUPERIORITY_OR_OTHER|||||||0.004||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.004
91791444|NCT00706849|183460557|SUPERIORITY_OR_OTHER|||||||0.207||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.207
91791445|NCT01555957|183460582|SUPERIORITY|||||||0.94|||||||Chi-squared|||we hypothesized that among ≥ 34 weeks GA infants with GISDs, infants receiving 1g/kg/day S-ILE (lipid minimizing strategy) would have decreased incidence of IFALD compared to those receiving 2g/kg/day S-ILE. We also hypothesized that the rate of rise of DB would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.94
91791446|NCT01555957|183460583|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||We also hypothesized that the rate of rise of direct bilirubin would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.0005
91791447|NCT01198158|183460584|SUPERIORITY|||||||0.739|||||||Log Rank|OS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors.||||||0.739
91791448|NCT01198158|183460585|SUPERIORITY|||||||0.832|||||||Log Rank|PFS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors||||||0.832
91791449|NCT05478174|183460593|NON_INFERIORITY|Non inferiority margin is -8%|Risk Difference (RD)|-0.0078|||<|0.001|TWO_SIDED|95.0|-0.0411|0.0255||P-Value for non inferiority test|Farrington-Manning method|||||0.0255|-0.0411|<0.001
91791450|NCT05478174|183460594|SUPERIORITY||Risk Difference (RD)|-0.0716||||0.171|TWO_SIDED|95.0|-0.1742|0.031|||Cochran-Mantel-Haenszel|||||0.0310|-0.1742|0.171
91791451|NCT05478174|183460595|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.231|<|0.001|TWO_SIDED|95.0|-2.22|-1.31|||ANOVA|||||-1.31|-2.22|<0.001
91791452|NCT01545843|183460596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Mixed Models Analysis|||||||.202
91791453|NCT03390842|183460607|SUPERIORITY||Difference in % of subjects|24.9|||=|0.0015|TWO_SIDED|95.0|10.2|38.7|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||38.7|10.2|= 0.0015
91791454|NCT03390842|183460607|SUPERIORITY||Treatment difference in % of subjects|24.4|||=|0.0015|TWO_SIDED|95.0|9.7|38.2|||Fisher Exact|||% Subjects with ≥ 4mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||38.2|9.7|= 0.0015
91791455|NCT03390842|183460607|SUPERIORITY||Treatment difference in % of subjects|30.2|||<|0.0001|TWO_SIDED|95.0|15.6|43.7|||Fisher Exact|||% Subjects with Serum Bicarbonate in Normal Range (22 - 29 mEq/L): TRC101-Placebo||43.7|15.6|< 0.0001
91791456|NCT03390842|183460608|SUPERIORITY||Treatment difference in LS means|1.99|STANDARD_ERROR_OF_MEAN|0.524|=|0.0002|TWO_SIDED|95.0|0.96|3.03|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares Mean Change from Baseline: TRC101-Placebo||3.03|0.96|= 0.0002
91791457|NCT03390842|183460609|SUPERIORITY||||||<|0.0001||||||p-value based on analysis of covariance model with rank of change from baseline in total score as dependent variable; treatment (PBO or TRC101) as a fixed effect; and baseline total score, Baseline eGFR, Baseline Bicarbonate as continuous covariates.|ANCOVA|||Mean Change from Baseline in KDQOL-PFD: TRC101-Placebo||||< 0.0001
91791458|NCT03390842|183460610|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from Baseline for Repeated Chair Stand Test: TRC101-Placebo||||< 0.0001
91791459|NCT00713310|183460621|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|-1.1||||0.924|TWO_SIDED|95.0|-22.7|20.5|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||20.5|-22.7|0.9240
91617033|NCT03050359|183127486|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-10%, the HP eradication rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|4.7|||||TWO_SIDED|95.0|-1.281|10.69||||||||10.690|-1.281|
91617034|NCT03050359|183127487|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.7|||||TWO_SIDED|95.0|-4.901|6.319||||||||6.319|-4.901|
91617035|NCT03050359|183127488|OTHER||Difference in percentages|-4.1|||||TWO_SIDED|95.0|-15.579|7.344||||||Epigastric Pain (Postprandial)||7.344|-15.579|
91617036|NCT03050359|183127488|OTHER||Difference in percentages|1.6|||||TWO_SIDED|95.0|-5.23|8.422||||||Epigastric Pain (Fasting/Nocturnal)||8.422|-5.230|
91617037|NCT03050359|183127488|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-17.338|9.401||||||Abdominal Bloating||9.401|-17.338|
91617038|NCT03050359|183127488|OTHER||Difference in percentages|-9.3|||||TWO_SIDED|95.0|-26.334|7.815||||||Nausea/Vomiting||7.815|-26.334|
91524373|NCT02799472|182923974|OTHER||Ratio|1.017||||0.939|TWO_SIDED|95.0|0.649|1.593|||Repeated measures analysis|||S100 CBP A8 and A9, Week 4||1.593|0.649|0.939
91617039|NCT03050359|183127488|OTHER||Difference in percentages|4.5|||||TWO_SIDED|95.0|-4.159|13.25||||||Heartburn||13.250|-4.159|
91524374|NCT02799472|182923974|OTHER||Ratio|0.981||||0.937|TWO_SIDED|95.0|0.595|1.617|||Repeated measures analysis|||S100 CBP A8 and A9, Week 6||1.617|0.595|0.937
91524375|NCT02799472|182923974|OTHER||Ratio|1.067||||0.787|TWO_SIDED|95.0|0.659|1.727|||Repeated measures analysis|||S100 CBP A8 and A9, Week 8||1.727|0.659|0.787
91617040|NCT03050359|183127488|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-21.104|2.922||||||Lack of Appetite||2.922|-21.104|
91617041|NCT02020031|183127489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
91617042|NCT02020031|183127489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
91617043|NCT02020031|183127489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
91617044|NCT02020031|183127489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
91657347|NCT02937701|183208224|OTHER||Response Difference|-2.43|||||TWO_SIDED|90.0|-7.47|2.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||2.64|-7.47|
91657348|NCT02937701|183208224|OTHER||Response Difference|5.46|||||TWO_SIDED|90.0|-0.01|10.91||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.91|-0.01|
91657349|NCT02937701|183208224|OTHER||Response Difference|4.58|||||TWO_SIDED|90.0|-1.21|10.34||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.34|-1.21|
91657350|NCT02937701|183208225|OTHER||Response Difference|0.2|||||TWO_SIDED|90.0|-8.12|8.02||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.02|-8.12|
91657351|NCT02937701|183208225|OTHER||Response Difference|-0.08|||||TWO_SIDED|90.0|-9.39|9.28||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.28|-9.39|
91657352|NCT02937701|183208225|OTHER||Response Difference|1.5|||||TWO_SIDED|90.0|-7.0|9.51||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.51|-7.00|
91657353|NCT02937701|183208225|OTHER||Response Difference|7.49|||||TWO_SIDED|90.0|-2.39|17.22||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.22|-2.39|
91657354|NCT02937701|183208225|OTHER||Response Difference|-0.5|||||TWO_SIDED|90.0|-9.03|7.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.59|-9.03|
91657355|NCT02937701|183208225|OTHER||Response Difference|3.39|||||TWO_SIDED|90.0|-6.41|13.14||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.14|-6.41|
91657356|NCT02937701|183208225|OTHER||Response Difference|-0.43|||||TWO_SIDED|90.0|-8.98|7.66||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.66|-8.98|
91712743|NCT02358031|183317162|OTHER||Difference in ORR Percentage|-15.9||||1|TWO_SIDED|95.0|-23.4|-8.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||-8.3|-23.4|1.0000
91657357|NCT02937701|183208225|OTHER||Response Difference|7.87|||||TWO_SIDED|90.0|-2.13|17.68||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.68|-2.13|
91657358|NCT02937701|183208225|OTHER||Response Difference|1.95|||||TWO_SIDED|90.0|-6.81|10.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.29|-6.81|
91657359|NCT02937701|183208225|OTHER||Response Difference|12.06|||||TWO_SIDED|90.0|1.74|22.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||22.04|1.74|
91657360|NCT02937701|183208226|OTHER||Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.2|0.007||||||Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.007|-0.20|
91524376|NCT02799472|182923974|OTHER||Ratio|1.267||||0.342|TWO_SIDED|95.0|0.769|2.086|||Repeated measures analysis|||S100 CBP A8 and A9, Week 12||2.086|0.769|0.342
91617045|NCT02020031|183127489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
91617046|NCT02020031|183127489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
91617047|NCT00755846|183127492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.135||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
91617048|NCT00755846|183127492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.171||0.004||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
91617049|NCT00755846|183127492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.176||0.017||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
91617050|NCT00755846|183127492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.001||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
91617051|NCT00755846|183127492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.174||0.003||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.003
91617052|NCT00755846|183127492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.173||0.307||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.307
91657361|NCT02937701|183208226|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.17|0.16||||||Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.16|-0.17|
91657362|NCT02937701|183208226|OTHER||Mean Difference|-0.04|||||TWO_SIDED|90.0|-0.21|0.14||||||Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.14|-0.21|
91524377|NCT02799472|182923974|OTHER||Ratio|1.748||||0.026|TWO_SIDED|95.0|1.076|2.838|||Repeated measures analysis|||S100 CBP A8 and A9, 12-Week FU||2.838|1.076|0.026
91617053|NCT00755846|183127493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
91657363|NCT02937701|183208226|OTHER||Mean Difference|-0.01|||||TWO_SIDED|90.0|-0.2|0.17||||||Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.17|-0.20|
91657364|NCT02937701|183208227|OTHER||Mean Difference|0.16|||||TWO_SIDED|90.0|-0.08|0.4||||||Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.40|-0.08|
91657365|NCT02937701|183208227|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.27|0.28||||||Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.28|-0.27|
91524378|NCT02799472|182923975|OTHER||Ratio|0.774||||0.632|TWO_SIDED|95.0|0.261|2.29|||Repeated measures analysis|||Amyloid A, Week 12||2.290|0.261|0.632
91524379|NCT02799472|182923975|OTHER||Ratio|1.176||||0.685|TWO_SIDED|95.0|0.519|2.663|||Repeated measures analysis|||Amyloid A, 12-Week FU||2.663|0.519|0.685
91524380|NCT02799472|182923976|OTHER||Ratio|0.692||||0.097|TWO_SIDED|95.0|0.445|1.074|||Repeated measures analysis|||CL17, Week 1||1.074|0.445|0.097
91524381|NCT02799472|182923976|OTHER||Ratio|0.713||||0.229|TWO_SIDED|95.0|0.407|1.249|||Repeated measures analysis|||CL17, Week 2||1.249|0.407|0.229
91617054|NCT00755846|183127493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.134||0.017||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
91617055|NCT00755846|183127493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.138||0.016||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.016
91617056|NCT00755846|183127493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.134||0.005||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.005
91617057|NCT00755846|183127493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.137||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.008
91617058|NCT00755846|183127493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.136||0.321||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.321
91524382|NCT02799472|182923976|OTHER||Ratio|0.608||||0.055|TWO_SIDED|95.0|0.365|1.012|||Repeated measures analysis|||CL17, Week 4||1.012|0.365|0.055
91712744|NCT02358031|183317163|OTHER||Difference in ORR Percentage|-12.8||||0.9869|TWO_SIDED|95.0|-23.8|-1.5||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||-1.5|-23.8|0.9869
91657366|NCT02937701|183208227|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.12|0.35||||||Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.35|-0.12|
91657367|NCT02937701|183208227|OTHER||Mean Difference|-0.03|||||TWO_SIDED|90.0|-0.3|0.24||||||Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.30|
91657368|NCT02937701|183208227|OTHER||Mean Difference|0.06|||||TWO_SIDED|90.0|-0.18|0.3||||||Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.30|-0.18|
91524383|NCT02799472|182923976|OTHER||Ratio|0.755||||0.307|TWO_SIDED|95.0|0.435|1.309|||Repeated measures analysis|||CL17, Week 6||1.309|0.435|0.307
91722425|NCT04390750|183337443|OTHER|The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 1 and Control at 3 months.|Interaction coefficient|0.0||||0.995||95.0|-0.16|0.16|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the primary endpoint of 3 months.||0.16|-0.16|0.995
91524384|NCT02799472|182923976|OTHER||Ratio|0.557||||0.017|TWO_SIDED|95.0|0.348|0.894|||Repeated measures analysis|||CL17, Week 8||0.894|0.348|0.017
91657369|NCT02937701|183208227|OTHER||Mean Difference|-0.08|||||TWO_SIDED|90.0|-0.36|0.2||||||Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.20|-0.36|
91657370|NCT02937701|183208227|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.14|0.37||||||Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.37|-0.14|
91657371|NCT02937701|183208227|OTHER||Mean Difference|-0.05|||||TWO_SIDED|90.0|-0.34|0.25||||||Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.25|-0.34|
91657372|NCT02937701|183208227|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.24|0.24||||||Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.24|
91524385|NCT02799472|182923976|OTHER||Ratio|0.52||||0.026|TWO_SIDED|95.0|0.294|0.922|||Repeated measures analysis|||||0.922|0.294|0.026
91524386|NCT02799472|182923976|OTHER||Ratio|0.947||||0.839|TWO_SIDED|95.0|0.548|1.636|||Repeated measures analysis|||CL17, 12-Week FU||1.636|0.548|0.839
91617059|NCT00755846|183127494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91617060|NCT00755846|183127494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|STANDARD_ERROR_OF_MEAN|8.4|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91617061|NCT00755846|183127494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|8.68||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
91617062|NCT00755846|183127494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.38|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91657373|NCT02937701|183208227|OTHER||Mean Difference|-0.2|||||TWO_SIDED|90.0|-0.47|0.08||||||Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.08|-0.47|
91657374|NCT01507051|183208228|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|2.793|||<|0.0001||90.0|2.633|2.962|||ANOVA|||||2.962|2.633|<0.0001
91657375|NCT01507051|183208229|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|6.151|||<|0.0001||90.0|5.598|6.759|||ANOVA|||||6.759|5.598|<0.0001
91657376|NCT01507051|183208256|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.17||||0.5008||95.0|82.2|110.2|||ANOVA|||||110.2|82.20|0.5008
91657377|NCT01507051|183208257|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|99.46||||0.9429||95.0|85.47|115.7|||ANOVA|||||115.7|85.47|0.9429
91657378|NCT01507051|183208258|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|100.4||||0.9525||95.0|88.0|114.5|||ANOVA|||||114.5|88.00|0.9525
91657379|NCT01507051|183208259|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.87||||0.4397||95.0|85.99|106.9|||ANOVA|||||106.9|85.99|0.4397
91657380|NCT01101022|183208270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|||<|0.0001|TWO_SIDED|95.0|-15.9|-6.4|||ANCOVA|||||-6.4|-15.9|<0.0001
91657381|NCT01101022|183208271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.6|||<|0.0001|TWO_SIDED|95.0|13.5|29.7|||ANCOVA|||Performance and Daily Functioning||29.7|13.5|<0.0001
91712745|NCT02358031|183317164|OTHER||Difference in LS Means|0.24||||0.893|TWO_SIDED|95.0|-3.34|3.82||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||3.82|-3.34|0.893
91712746|NCT02358031|183317165|OTHER||Hazard Ratio (HR)|1.38||||0.953|TWO_SIDED|95.0|0.95|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.95|0.9530
91712747|NCT02358031|183317166|OTHER||Hazard Ratio (HR)|0.8||||0.1501|TWO_SIDED|95.0|0.53|1.21||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.21|0.53|0.1501
91712748|NCT02358031|183317167|OTHER||Hazard Ratio (HR)|1.26||||0.8751|TWO_SIDED|95.0|0.85|1.88||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.88|0.85|0.8751
91712749|NCT03442725|183317170|OTHER||Geometric Mean Ratio|1.297|||||TWO_SIDED|90.0|0.6|2.805||||||Analysis of variance (ANOVA) comparison of Cmax for telotristat ethyl between test group versus the control group.||2.805|0.600|
91712750|NCT03442725|183317170|OTHER||Geometric Mean Ratio|1.423|||||TWO_SIDED|90.0|0.901|2.247||||||ANOVA comparison of Cmax for LP-778902 between test group versus the control group.||2.247|0.901|
91712751|NCT03442725|183317171|OTHER|Estimate of the median difference and 90% confidence intervals (CIs) was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7452|TWO_SIDED|90.0|-1.0|0.95|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for telotristat ethyl between test group versus the control group.||0.950|-1.000|0.7452
91524387|NCT02799472|182923976|OTHER||Ratio|0.764||||0.142|TWO_SIDED|95.0|0.53|1.1|||Repeated measures analysis|||CL13, Week 1||1.100|0.530|0.142
91657382|NCT01101022|183208271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|||<|0.0001|TWO_SIDED|95.0|7.8|22.0|||ANCOVA|||Daily Interference||22.0|7.8|<0.0001
91657383|NCT01101022|183208271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.5||||0.0003|TWO_SIDED|95.0|6.3|20.7|||ANCOVA|||Bother/Concern||20.7|6.3|0.0003
91657384|NCT01101022|183208271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.0302|TWO_SIDED|95.0|0.8|14.9|||ANCOVA|||Relationships/Communication||14.9|0.8|0.0302
91657385|NCT01101022|183208272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0016|TWO_SIDED|95.0|-7.8|-1.9|||ANCOVA|||Global Executive Composite||-1.9|-7.8|0.0016
91657386|NCT01101022|183208272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.0355|TWO_SIDED|95.0|-6.0|-0.2|||ANCOVA|||Behavioral Regulation Index||-0.2|-6.0|0.0355
91524388|NCT02799472|182923976|OTHER||Ratio|1.005||||0.976|TWO_SIDED|95.0|0.726|1.39|||Repeated measures analysis|||CL13, Week 2||1.390|0.726|0.976
91657387|NCT01101022|183208272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.7|-2.7|||ANCOVA|||Metacognition Index||-2.7|-8.7|0.0003
91657388|NCT01101022|183208273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4||||0.0002|TWO_SIDED|95.0|-12.7|-4.0|||ANCOVA|||Behavioral Regulation Index||-4.0|-12.7|0.0002
91657389|NCT01101022|183208273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.3|-7.0|||ANCOVA|||Metacognition Index||-7.0|-16.3|<0.0001
91657390|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.0001|TWO_SIDED|95.0|-12.6|-4.1|||ANCOVA|||Inhibit||-4.1|-12.6|0.0001
91657391|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7||||0.0018|TWO_SIDED|95.0|-10.8|-2.5|||ANCOVA|||Shift||-2.5|-10.8|0.0018
91657392|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2||||0.0056|TWO_SIDED|95.0|-8.8|-1.5|||ANCOVA|||Emotional control||-1.5|-8.8|0.0056
91617063|NCT00755846|183127494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|8.57||0.057||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.057
91617064|NCT00755846|183127494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|8.56||0.156||95.0||||No multiplicity adjustments|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.156
91617065|NCT00755846|183127495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|STANDARD_ERROR_OF_MEAN|7.05|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91657393|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2||||0.0001|TWO_SIDED|95.0|-12.3|-4.1|||ANCOVA|||Sef-monitor||-4.1|-12.3|0.0001
91657394|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.2|-5.4|||ANCOVA|||Initiate||-5.4|-13.2|<0.0001
91657395|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.0|-6.6|||ANCOVA|||Working memory||-6.6|-16.0|<0.0001
91657396|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|||<|0.0001|TWO_SIDED|95.0|-15.4|-6.4|||ANCOVA|||Plan/Organize||-6.4|-15.4|<0.0001
91617066|NCT00755846|183127495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.91||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.001
91617067|NCT00755846|183127495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|9.2||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.008
91617068|NCT00755846|183127495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|8.88|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91617069|NCT00755846|183127495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|9.09||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
91617070|NCT00755846|183127495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|9.07||0.073||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.073
91617071|NCT00755846|183127496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|5.85|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91617072|NCT00755846|183127496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|7.37||0.01||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.010
91617073|NCT00755846|183127496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|7.71||0.002||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.002
91524389|NCT02799472|182923976|OTHER||Ratio|1.236||||0.244|TWO_SIDED|95.0|0.859|1.778|||Repeated measures analysis|||CL13, Week 4||1.778|0.859|0.244
91657397|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-14.0|-4.7|||ANCOVA|||Task monitor||-4.7|-14.0|0.0001
91657398|NCT01101022|183208274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-5.3|||ANCOVA|||Organization of materials||-5.3|-12.5|<0.0001
91617074|NCT00755846|183127496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|7.33||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
91617075|NCT00755846|183127496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|7.44||0.006||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.006
91617076|NCT00755846|183127496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|7.45||0.117||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.117
91617077|NCT00755846|183127497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|6.6||0.014||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.014
91617078|NCT00755846|183127497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|8.35||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
91617079|NCT00755846|183127497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|STANDARD_ERROR_OF_MEAN|8.73||0.022||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.022
91617080|NCT00755846|183127497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|8.26||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.004
91657399|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||ANCOVA|||Inhibit||-1.4|-7.4|0.0048
91657400|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8||||0.0045|TWO_SIDED|95.0|-8.0|-1.5|||ANCOVA|||Shift||-1.5|-8.0|0.0045
91657401|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.3605|TWO_SIDED|95.0|-4.0|1.5|||ANCOVA|||Emotional control||1.5|-4.0|0.3605
91657402|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2||||0.1468|TWO_SIDED|95.0|-5.1|0.8|||ANCOVA|||Self-monitor||0.8|-5.1|0.1468
91657403|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0002|TWO_SIDED|95.0|-8.3|-2.7|||ANCOVA|||Initiate||-2.7|-8.3|0.0002
91657404|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||Working memory||-2.9|-9.8|0.0004
91524390|NCT02799472|182923976|OTHER||Ratio|1.237||||0.278|TWO_SIDED|95.0|0.836|1.83|||Repeated measures analysis|||CL13, Week 6||1.830|0.836|0.278
91617081|NCT00755846|183127497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|8.48||0.04||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.040
91617082|NCT00755846|183127497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|8.47||0.378||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.378
91617083|NCT00755846|183127498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.37||0.718||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.718
91617084|NCT00755846|183127498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.8||0.346||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.346
91617085|NCT00755846|183127498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|7.13||0.901||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.901
91617086|NCT00755846|183127498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|6.79||0.851||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.851
91617087|NCT00755846|183127498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|6.86||0.825||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.825
91617088|NCT00755846|183127498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|6.94||0.843||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.843
91617089|NCT00755846|183127499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.88||0.069||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.069
91657405|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0015|TWO_SIDED|95.0|-7.9|-1.9|||ANCOVA|||Plan/Organize||-1.9|-7.9|0.0015
91657406|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0003|TWO_SIDED|95.0|-9.7|-2.9|||ANCOVA|||Task monitor||-2.9|-9.7|0.0003
91657407|NCT01101022|183208275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0234|TWO_SIDED|95.0|-5.9|-0.4|||ANCOVA|||Organization of materials||-0.4|-5.9|0.0234
91617090|NCT00755846|183127499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_ERROR_OF_MEAN|6.14||0.018||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.018
91617091|NCT00755846|183127499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|6.47||0.258||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.258
91617092|NCT00755846|183127499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.13||0.299||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.299
91617093|NCT00755846|183127499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|6.27||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
91617094|NCT00755846|183127499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|6.32||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
91617095|NCT00755846|183127500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.689||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.689
91617096|NCT00755846|183127500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.742||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.742
91617097|NCT00755846|183127500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.22||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.220
91657408|NCT01101022|183208276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-14.9|-7.3|||ANCOVA|||||-7.3|-14.9|<0.0001
91657409|NCT01101022|183208279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91657410|NCT01101022|183208280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.4|12.7|||ANCOVA|||Living with ADHD||12.7|5.4|<0.0001
91524391|NCT02799472|182923976|OTHER||Ratio|1.118||||0.677|TWO_SIDED|95.0|0.651|1.92|||Repeated measures analysis|||CL13, Week 8||1.920|0.651|0.677
91524392|NCT02799472|182923976|OTHER||Ratio|1.165||||0.661|TWO_SIDED|95.0|0.573|2.369|||Repeated measures analysis|||CL13, Week 12||2.369|0.573|0.661
91657411|NCT01101022|183208280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|6.0|15.5|||ANCOVA|||General Well-being||15.5|6.0|<0.0001
91657412|NCT01101022|183208281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.0184|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Question 1||1.0|0.1|0.0184
91657413|NCT01101022|183208281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Question 4||-0.3|-0.9|0.0004
91657414|NCT01101022|183208282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0019|TWO_SIDED|95.0|-9.0|-2.1|||ANCOVA|||||-2.1|-9.0|0.0019
91657415|NCT01101022|183208283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0017|TWO_SIDED|95.0|-8.2|-1.9|||ANCOVA|||Inattention/Memory Problems||-1.9|-8.2|0.0017
91657416|NCT01101022|183208283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.0174|TWO_SIDED|95.0|-7.5|-0.7|||ANCOVA|||Hyperactivity/Restlessness||-0.7|-7.5|0.0174
91657417|NCT01101022|183208283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0063|TWO_SIDED|95.0|-6.8|-1.1|||ANCOVA|||Impulsivity/Emotional Liability||-1.1|-6.8|0.0063
91617098|NCT00755846|183127500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.05||0.348||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.348
91617099|NCT00755846|183127500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.06||0.627||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.627
91617100|NCT00755846|183127500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.06||0.418||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.418
91617101|NCT00755846|183127501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.617||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.617
91617102|NCT00755846|183127501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.2||0.052||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.052
91617103|NCT00755846|183127501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.28||0.906||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.906
91657418|NCT01101022|183208283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0059|TWO_SIDED|95.0|-7.5|-1.3|||ANCOVA|||Problems with Self-concept||-1.3|-7.5|0.0059
91657419|NCT01101022|183208284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.0||||0.0016|TWO_SIDED|95.0|8.4|33.6|||ANCOVA|||Life Productivity||33.6|8.4|0.0016
91657420|NCT01101022|183208284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1||||0.0242|TWO_SIDED|95.0|1.6|22.5|||ANCOVA|||Psychological Health||22.5|1.6|0.0242
91657421|NCT01101022|183208284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5||||0.0038|TWO_SIDED|95.0|4.2|20.8|||ANCOVA|||Life Outlook||20.8|4.2|0.0038
91657422|NCT01101022|183208284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1752|TWO_SIDED|95.0|-3.4|18.0|||ANCOVA|||Relationships||18.0|-3.4|0.1752
91657423|NCT01101022|183208284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.7||||0.0015|TWO_SIDED|95.0|5.9|23.6|||ANCOVA|||Total Score||23.6|5.9|0.0015
91657424|NCT00581139|183208302|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
91657425|NCT00581139|183208304|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
91657426|NCT00581139|183208305|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
91657427|NCT00581139|183208306|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
91657428|NCT00581139|183208307|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
91617104|NCT00755846|183127501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.19||0.628||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.628
91617105|NCT00755846|183127501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.22||0.749||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.749
91617106|NCT00755846|183127501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.22||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
91617107|NCT00755846|183127502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.31||0.269||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.269
91617108|NCT00755846|183127502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.46||0.076||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.076
91617109|NCT00755846|183127502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|5.66||0.867||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.867
91617110|NCT00755846|183127502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.4||0.169||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.169
91617111|NCT00755846|183127502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.45||0.645||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.645
91657429|NCT00581139|183208308|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
91657430|NCT00581139|183208309|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
91524393|NCT02799472|182923976|OTHER||Ratio|1.581||||0.154|TWO_SIDED|95.0|0.832|3.007|||Repeated measures analysis|||CL13, 12-Week FU||3.007|0.832|0.154
91524394|NCT02799472|182923976|OTHER||Ratio|0.903||||0.751|TWO_SIDED|95.0|0.471|1.729|||Repeated measures analysis|||Interleukin 6, Week 1||1.729|0.471|0.751
91617112|NCT00755846|183127502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.51||0.351||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.351
91617113|NCT00755846|183127503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|4.03||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
91617114|NCT00755846|183127503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|5.06|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
91657431|NCT00420303|183208310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47||||0.029||95.0|-32.93|-2.01|||ANCOVA|Treatment groups as fixed factors, baseline value as covariate||Comparison of adjusted means||-2.01|-32.93|0.029
91657432|NCT00420303|183208311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.02||95.0|1.44|69.26|||Generalized estimating equations (GEE)|Logit link, a binomial distribution and an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors.||||69.26|1.44|0.02
91657433|NCT00420303|183208312|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANCOVA|Treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||||||0.007
91657434|NCT04455633|183208335|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.249||0.007|TWO_SIDED|95.0|-1.16|-0.18|||MMRM model|||Mixed model repeated measures (MMRM) model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.18|-1.16|0.007
91657435|NCT04455633|183208335|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.254||0.03|TWO_SIDED|95.0|-1.06|-0.05|||MMRM model|||MMRM model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.05|-1.06|0.030
91657436|NCT04455633|183208336|SUPERIORITY||Difference in Percentage of Responders|9.6||||0.091|TWO_SIDED|95.0|-1.55|20.76|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% confidence interval (CI) are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||20.76|-1.55|0.091
91657437|NCT04455633|183208336|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.883|TWO_SIDED|95.0|-10.95|9.4|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||9.40|-10.95|0.883
91657438|NCT04455633|183208337|SUPERIORITY||Difference in Percentage of Responders|4.8||||0.289|TWO_SIDED|95.0|-4.11|13.73|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||13.73|-4.11|0.289
91657439|NCT04455633|183208337|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.837|TWO_SIDED|95.0|-8.85|7.16|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||7.16|-8.85|0.837
91657440|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.298||0.014|TWO_SIDED|95.0|-1.32|-0.15|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.15|-1.32|0.014
91657441|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.017|TWO_SIDED|95.0|-1.27|-0.13|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.13|-1.27|0.017
91657442|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.302||0.015|TWO_SIDED|95.0|-1.33|-0.15|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.15|-1.33|0.015
91657443|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.294||0.02|TWO_SIDED|95.0|-1.27|-0.11|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.11|-1.27|0.020
91617115|NCT00755846|183127503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|5.26||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
91617116|NCT00755846|183127503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|4.98||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
91617117|NCT00755846|183127503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.14||0.034||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.034
91617118|NCT00755846|183127503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|5.16||0.033||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.033
91617119|NCT00755846|183127504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|17.17||0.897||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.897
91617120|NCT00755846|183127504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|STANDARD_ERROR_OF_MEAN|21.85||0.557||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.557
91617121|NCT00755846|183127504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5|STANDARD_ERROR_OF_MEAN|22.85||0.616||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.616
91617122|NCT00755846|183127504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|21.73||0.679||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.679
91617123|NCT00755846|183127504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|21.94||0.697||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.697
91657444|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.309||0.005|TWO_SIDED|95.0|-1.48|-0.27|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||-0.27|-1.48|0.005
91617124|NCT00755846|183127504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|22.03||0.672||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.672
91617125|NCT00755846|183127505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|16.37||0.809||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.809
91617126|NCT00755846|183127505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|20.74||0.597||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.597
91617127|NCT00755846|183127505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|21.77||0.982||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.982
91617128|NCT00755846|183127505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|20.62||0.358||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.358
91617129|NCT00755846|183127505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|21.06||0.274||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.274
91617130|NCT00755846|183127505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|21.06||0.554||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.554
91617131|NCT04047121|183127507|SUPERIORITY|||||||0.2531|||||||Chi-squared|||||||0.2531
91617132|NCT04047121|183127507|SUPERIORITY|||||||0.0295|||||||Chi-squared|||||||0.0295
91617133|NCT04047121|183127507|SUPERIORITY|||||||0.1857|||||||Chi-squared|||||||0.1857
91617134|NCT04047121|183127507|SUPERIORITY||Odds Ratio (OR)|0.8401||||0.3297|TWO_SIDED|95.0|0.5919|1.1925|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1925|0.5919|0.3297
91617135|NCT04047121|183127507|SUPERIORITY||Odds Ratio (OR)|1.5066||||0.2003|TWO_SIDED|95.0|0.8046|2.8209|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.8209|0.8046|0.2003
91617136|NCT04047121|183127507|SUPERIORITY||Odds Ratio (OR)|1.4052||||0.2276|TWO_SIDED|95.0|0.8086|2.442|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.4420|0.8086|0.2276
91617137|NCT04047121|183127508|SUPERIORITY|||||||0.8786|||||||Chi-squared|||||||0.8786
91712752|NCT03442725|183317171|OTHER|Estimate of the median difference and 90% CIs was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7039|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for LP-778902 between test group versus the control group.||1.000|-1.000|0.7039
91712753|NCT03442725|183317173|OTHER||Geometric Mean Ratio|1.506|||||TWO_SIDED|90.0|0.914|2.48||||||ANOVA comparison of AUC0-inf for LP-778902 between test group versus the control group.||2.480|0.914|
91617138|NCT04047121|183127508|SUPERIORITY|||||||0.1178|||||||Chi-squared|||||||0.1178
91524395|NCT02799472|182923976|OTHER||Ratio|0.72||||0.33|TWO_SIDED|95.0|0.367|1.413|||Repeated measures analysis|||Interleukin 6, Week 2||1.413|0.367|0.330
91617139|NCT04047121|183127508|SUPERIORITY|||||||0.5337|||||||Chi-squared|||||||0.5337
91617140|NCT04047121|183127508|SUPERIORITY||Odds Ratio (OR)|1.0283||||0.9212|TWO_SIDED|95.0|0.5911|1.789|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7890|0.5911|0.9212
91617141|NCT04047121|183127508|SUPERIORITY||Odds Ratio (OR)|0.7464||||0.4693|TWO_SIDED|95.0|0.338|1.6482|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6482|0.3380|0.4693
91617142|NCT04047121|183127508|SUPERIORITY||Odds Ratio (OR)|0.8212||||0.5593|TWO_SIDED|95.0|0.4239|1.591|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5910|0.4239|0.5593
91617143|NCT04047121|183127509|SUPERIORITY|||||||0.6205|||||||Chi-squared|||||||0.6205
91617144|NCT04047121|183127509|SUPERIORITY|||||||0.4924|||||||Chi-squared|||||||0.4924
91617145|NCT04047121|183127509|SUPERIORITY|||||||0.4982|||||||Chi-squared|||||||0.4982
91617146|NCT04047121|183127509|SUPERIORITY||Odds Ratio (OR)|1.3182||||0.5494|TWO_SIDED|95.0|0.5335|3.257|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2570|0.5335|0.5494
91617147|NCT04047121|183127509|SUPERIORITY||Odds Ratio (OR)|1.1664||||0.783|TWO_SIDED|95.0|0.39|3.4883|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.4883|0.3900|0.7830
91617148|NCT04047121|183127510|SUPERIORITY|||||||0.3817|||||||Chi-squared|||||||0.3817
91617149|NCT04047121|183127510|SUPERIORITY|||||||0.7397|||||||Chi-squared|||||||0.7397
91617150|NCT04047121|183127510|SUPERIORITY|||||||0.7942|||||||Chi-squared|||||||0.7942
91617151|NCT04047121|183127510|SUPERIORITY||Odds Ratio (OR)|1.0682||||0.7924|TWO_SIDED|95.0|0.6537|1.7455|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7455|0.6537|0.7924
91617152|NCT04047121|183127510|SUPERIORITY||Odds Ratio (OR)|1.0414||||0.9339|TWO_SIDED|95.0|0.3997|2.7134|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7134|0.3997|0.9339
91617153|NCT04047121|183127510|SUPERIORITY||Odds Ratio (OR)|0.8195||||0.6497|TWO_SIDED|95.0|0.347|1.935|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9350|0.3470|0.6497
91617154|NCT04047121|183127511|SUPERIORITY|||||||0.7936|||||||Chi-squared|||||||0.7936
91617155|NCT04047121|183127511|SUPERIORITY|||||||0.5621|||||||Chi-squared|||||||0.5621
91657445|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.111|TWO_SIDED|95.0|-1.07|0.11|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||0.11|-1.07|0.111
91657446|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.31||0.399|TWO_SIDED|95.0|-0.87|0.35|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.35|-0.87|0.399
91657447|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.302||0.441|TWO_SIDED|95.0|-0.83|0.36|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.36|-0.83|0.441
91617156|NCT04047121|183127511|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.6800
91617157|NCT04047121|183127511|SUPERIORITY||Odds Ratio (OR)|1.1438||||0.5051|TWO_SIDED|95.0|0.7705|1.6978|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6978|0.7705|0.5051
91617158|NCT04047121|183127511|SUPERIORITY||Odds Ratio (OR)|0.8576||||0.7131|TWO_SIDED|95.0|0.3781|1.9452|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9452|0.3781|0.7131
91617159|NCT04047121|183127511|SUPERIORITY||Odds Ratio (OR)|0.8415||||0.649|TWO_SIDED|95.0|0.4003|1.769|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7690|0.4003|0.6490
91617160|NCT04047121|183127512|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
91524396|NCT02799472|182923976|OTHER||Ratio|0.822||||0.519|TWO_SIDED|95.0|0.447|1.512|||Repeated measures analysis|||Interleukin 6, Week 4||1.512|0.447|0.519
91524397|NCT02799472|182923976|OTHER||Ratio|0.659||||0.147|TWO_SIDED|95.0|0.372|1.167|||Repeated measures analysis|||Interleukin 6, Week 6||1.167|0.372|0.147
91617161|NCT04047121|183127512|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
91617162|NCT04047121|183127512|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
91617163|NCT04047121|183127512|SUPERIORITY||Odds Ratio (OR)|1.1637||||0.5368|TWO_SIDED|95.0|0.7193|1.8827|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.8827|0.7193|0.5368
91617164|NCT04047121|183127512|SUPERIORITY||Odds Ratio (OR)|0.7757||||0.4685|TWO_SIDED|95.0|0.3904|1.5413|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5413|0.3904|0.4685
91617165|NCT04047121|183127512|SUPERIORITY||Odds Ratio (OR)|0.7354||||0.3112|TWO_SIDED|95.0|0.4057|1.333|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.3330|0.4057|0.3112
91617166|NCT04047121|183127513|SUPERIORITY|||||||0.8122|||||||Log Rank|||||||0.8122
91617167|NCT04047121|183127513|SUPERIORITY|||||||0.7766|||||||Log Rank|||||||0.7766
91617168|NCT04047121|183127513|SUPERIORITY|||||||0.8305|||||||Log Rank|||||||0.8305
91617169|NCT04047121|183127513|SUPERIORITY||Hazard Ratio (HR)|0.5814||||0.1845|TWO_SIDED|95.0|0.261|1.2952|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.2952|0.2610|0.1845
91617170|NCT04047121|183127513|SUPERIORITY||Hazard Ratio (HR)|1.5908||||0.2951|TWO_SIDED|95.0|0.6671|3.7936|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.7936|0.6671|0.2951
91617171|NCT04047121|183127513|SUPERIORITY||Hazard Ratio (HR)|1.3546||||0.4907|TWO_SIDED|95.0|0.6584|2.787|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7870|0.6584|0.4907
91617172|NCT04047121|183127514|SUPERIORITY|||||||0.6006|||||||Log Rank|||||||0.6006
91617173|NCT04047121|183127514|SUPERIORITY|||||||0.2941|||||||Log Rank|||||||0.2941
91617174|NCT04047121|183127514|SUPERIORITY|||||||0.961|||||||Log Rank|||||||0.9610
91617175|NCT04047121|183127514|SUPERIORITY||Hazard Ratio (HR)|0.5571||||0.0455|TWO_SIDED|95.0|0.314|0.9884|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||0.9884|0.3140|0.0455
91617176|NCT04047121|183127514|SUPERIORITY||Hazard Ratio (HR)|2.1781||||0.0274|TWO_SIDED|95.0|1.0904|4.3506|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||4.3506|1.0904|0.0274
91617177|NCT04047121|183127514|SUPERIORITY||Hazard Ratio (HR)|0.8896||||0.6787|TWO_SIDED|95.0|0.5114|1.5475|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5475|0.5114|0.6787
91617178|NCT04047121|183127515|SUPERIORITY|||||||0.9084|||||||Log Rank|||||||0.9084
91617179|NCT04047121|183127515|SUPERIORITY|||||||0.8325|||||||Log Rank|||||||0.8325
91617180|NCT04047121|183127515|SUPERIORITY|||||||0.963|||||||Log Rank|||||||0.9630
91617181|NCT04047121|183127515|SUPERIORITY||Hazard Ratio (HR)|1.0508||||0.7909|TWO_SIDED|95.0|0.7284|1.516|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5160|0.7284|0.7909
91617182|NCT04047121|183127515|SUPERIORITY||Hazard Ratio (HR)|0.8117||||0.6027|TWO_SIDED|95.0|0.37|1.7808|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7808|0.3700|0.6027
91617183|NCT04047121|183127515|SUPERIORITY||Hazard Ratio (HR)|1.1742||||0.6978|TWO_SIDED|95.0|0.5222|2.6404|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.6404|0.5222|0.6978
91617184|NCT04047121|183127516|SUPERIORITY|||||||0.1736|||||||Log Rank|||||||0.1736
91617185|NCT04047121|183127516|SUPERIORITY|||||||0.0195|||||||Log Rank|||||||0.0195
91617186|NCT04047121|183127516|SUPERIORITY|||||||0.2104|||||||Log Rank|||||||0.2104
91617187|NCT04047121|183127516|SUPERIORITY||Hazard Ratio (HR)|1.1723||||0.167|TWO_SIDED|95.0|0.9357|1.4687|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.4687|0.9357|0.1670
91617188|NCT04047121|183127516|SUPERIORITY||Hazard Ratio (HR)|0.7228||||0.1087|TWO_SIDED|95.0|0.4861|1.0747|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.0747|0.4861|0.1087
91617189|NCT04047121|183127516|SUPERIORITY||Hazard Ratio (HR)|0.8402||||0.3212|TWO_SIDED|95.0|0.5957|1.1852|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1852|0.5957|0.3212
91617190|NCT04047121|183127517|SUPERIORITY|||||||0.9361|||||||Chi-squared|||||||0.9361
91617191|NCT04047121|183127517|SUPERIORITY|||||||0.3851|||||||Chi-squared|||||||0.3851
91617192|NCT04047121|183127517|SUPERIORITY|||||||0.599|||||||Chi-squared|||||||0.5990
91712754|NCT03442725|183317174|OTHER||Geometric Mean Ratio|1.512|||||TWO_SIDED|90.0|0.915|2.498||||||ANOVA comparison of AUC0-tlast for LP-778902 between test group versus the control group.||2.498|0.915|
91617193|NCT04047121|183127517|SUPERIORITY||Odds Ratio (OR)|0.9954||||0.986|TWO_SIDED|95.0|0.5962|1.662|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6620|0.5962|0.9860
91617194|NCT04047121|183127517|SUPERIORITY||Odds Ratio (OR)|1.2959||||0.5813|TWO_SIDED|95.0|0.5158|3.2558|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2558|0.5158|0.5813
91617195|NCT04047121|183127517|SUPERIORITY||Odds Ratio (OR)|1.8182||||0.1789|TWO_SIDED|95.0|0.7604|4.3473|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.3473|0.7604|0.1789
91617196|NCT04047121|183127518|SUPERIORITY|||||||0.4009|||||||Chi-squared|||||||0.4009
91617197|NCT04047121|183127518|SUPERIORITY|||||||0.9765|||||||Chi-squared|||||||0.9765
91617198|NCT04047121|183127518|SUPERIORITY|||||||0.2849|||||||Chi-squared|||||||0.2849
91617199|NCT04047121|183127518|SUPERIORITY||Odds Ratio (OR)|0.8252||||0.5289|TWO_SIDED|95.0|0.4538|1.5007|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5007|0.4538|0.5289
91617200|NCT04047121|183127518|SUPERIORITY||Odds Ratio (OR)|0.9408||||0.927|TWO_SIDED|95.0|0.2553|3.4678|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4678|0.2553|0.9270
91617201|NCT04047121|183127518|SUPERIORITY||Odds Ratio (OR)|0.3968||||0.0707|TWO_SIDED|95.0|0.1456|1.0812|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0812|0.1456|0.0707
91617202|NCT04047121|183127519|SUPERIORITY|||||||0.2061|||||||Chi-squared|||||||0.2061
91617203|NCT04047121|183127519|SUPERIORITY|||||||0.1908|||||||Chi-squared|||||||0.1908
91617204|NCT04047121|183127520|SUPERIORITY|||||||0.8033|||||||Chi-squared|||||||0.8033
91712755|NCT03442725|183317178|OTHER||Arithmetic Mean Difference|0.019|||||TWO_SIDED|90.0|-0.03|0.068||||||ANOVA comparison of fu of LP-778902 between test group versus the control group.||0.068|-0.030|
91524398|NCT02799472|182923976|OTHER||Ratio|0.684||||0.166|TWO_SIDED|95.0|0.396|1.18|||Repeated measures analysis|||Interleukin 6, Week 8||1.180|0.396|0.166
91524399|NCT02799472|182923976|OTHER||Ratio|1.221||||0.432|TWO_SIDED|95.0|0.734|2.031|||Repeated measures analysis|||Interleukin 6, Week 12||2.031|0.734|0.432
91617205|NCT04047121|183127520|SUPERIORITY|||||||0.6669|||||||Chi-squared|||||||0.6669
91617206|NCT04047121|183127520|SUPERIORITY|||||||0.6477|||||||Chi-squared|||||||0.6477
91617207|NCT04047121|183127520|SUPERIORITY||Odds Ratio (OR)|0.7948||||0.5509|TWO_SIDED|95.0|0.3736|1.6907|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6907|0.3736|0.5509
91617208|NCT04047121|183127520|SUPERIORITY||Odds Ratio (OR)|0.6814||||0.6216|TWO_SIDED|95.0|0.1486|3.125|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1250|0.1486|0.6216
91617209|NCT04047121|183127520|SUPERIORITY||Odds Ratio (OR)|0.6974||||0.5506|TWO_SIDED|95.0|0.2135|2.2781|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2781|0.2135|0.5506
91617210|NCT04047121|183127521|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.1030
91617211|NCT04047121|183127521|SUPERIORITY|||||||0.9317|||||||Chi-squared|||||||0.9317
91617212|NCT04047121|183127521|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.2420
91617213|NCT04047121|183127521|SUPERIORITY||Odds Ratio (OR)|1.7474||||0.0869|TWO_SIDED|95.0|0.9222|3.3107|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.3107|0.9222|0.0869
91617214|NCT04047121|183127521|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8228|TWO_SIDED|95.0|0.3757|3.4266|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4266|0.3757|0.8228
91617215|NCT04047121|183127521|SUPERIORITY||Odds Ratio (OR)|1.565||||0.4855|TWO_SIDED|95.0|0.4446|5.5086|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.5086|0.4446|0.4855
91617216|NCT04047121|183127523|SUPERIORITY|||||||0.5092|||||||Chi-squared|||||||0.5092
91617217|NCT04047121|183127523|SUPERIORITY|||||||0.0201|||||||Chi-squared|||||||0.0201
91617218|NCT04047121|183127523|SUPERIORITY|||||||0.2799|||||||Chi-squared|||||||0.2799
91617219|NCT04047121|183127523|SUPERIORITY||Odds Ratio (OR)|0.9021||||0.5772|TWO_SIDED|95.0|0.6281|1.2958|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2958|0.6281|0.5772
91617220|NCT04047121|183127523|SUPERIORITY||Odds Ratio (OR)|1.3953||||0.3272|TWO_SIDED|95.0|0.7166|2.7169|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7169|0.7166|0.3272
91657448|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.346||0.575|TWO_SIDED|95.0|-0.87|0.49|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.49|-0.87|0.575
91657449|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.337||0.88|TWO_SIDED|95.0|-0.71|0.61|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.61|-0.71|0.880
91657450|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.978|TWO_SIDED|95.0|-0.73|0.71|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.71|-0.73|0.978
91657451|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.358||0.877|TWO_SIDED|95.0|-0.65|0.76|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.76|-0.65|0.877
91657452|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.079|TWO_SIDED|95.0|-1.32|0.07|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.07|-1.32|0.079
91657453|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.345||0.163|TWO_SIDED|95.0|-1.16|0.2|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.20|-1.16|0.163
91657454|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.344||0.875|TWO_SIDED|95.0|-0.73|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.73|0.875
91657455|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.335||0.914|TWO_SIDED|95.0|-0.69|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.69|0.914
91657456|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.351||0.219|TWO_SIDED|95.0|-0.26|1.12|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||1.12|-0.26|0.219
91657457|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.341||0.551|TWO_SIDED|95.0|-0.47|0.87|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||0.87|-0.47|0.551
91657458|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.339||0.005|TWO_SIDED|95.0|-1.63|-0.3|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.30|-1.63|0.005
91657459|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.329||0.002|TWO_SIDED|95.0|-1.68|-0.39|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.39|-1.68|0.002
91712756|NCT03442725|183317179|OTHER||Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.866|3.443||||||ANOVA comparison of Cmaxu for LP-778902 between test group versus the control group.||3.443|0.866|
91657460|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.361||0.955|TWO_SIDED|95.0|-0.73|0.69|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.69|-0.73|0.955
91657461|NCT04455633|183208338|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.351||0.777|TWO_SIDED|95.0|-0.79|0.59|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.59|-0.79|0.777
91657462|NCT04455633|183208340|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.031|TWO_SIDED|95.0|-0.67|-0.03|||ANOVA|||Analysis of variance (ANOVA) model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||-0.03|-0.67|0.031
91657463|NCT04455633|183208340|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.165||0.351|TWO_SIDED|95.0|-0.48|0.17|||ANOVA|||ANOVA model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||0.17|-0.48|0.351
91657464|NCT01027780|183208389|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Please note that this analysis tested the differences between groups following the intervention.|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.007
91617221|NCT04047121|183127523|SUPERIORITY||Odds Ratio (OR)|1.3527||||0.3011|TWO_SIDED|95.0|0.763|2.3983|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3983|0.7630|0.3011
91657465|NCT01027780|183208390|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Note that this is the p value for differences between groups immediately following the intervention|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.04
91657466|NCT01027780|183208391|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Difference between groups following intervention|ANOVA|||||||.03
91657467|NCT00365300|183208398|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||1|||||||Fisher Exact|||||||1.0
91657468|NCT01029353|183208399|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates.||1.14|0.87|
91617222|NCT04047121|183127524|SUPERIORITY|||||||0.2931|||||||Chi-squared|||||||0.2931
91617223|NCT04047121|183127524|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||0.3135
91617224|NCT04047121|183127524|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91617225|NCT04047121|183127524|SUPERIORITY||Odds Ratio (OR)|0.8369||||0.6772|TWO_SIDED|95.0|0.3618|1.9356|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.9356|0.3618|0.6772
91657469|NCT01029353|183208399|OTHER|||||||0.03||||||Pre-specified threshold = 0.05|Robust Poisson regression|||A frequentist analysis. Using Robust Poisson regression with log link and center as repeated measure, and effect coding, test for an interaction between treatment (Initial Laparotomy/Initial Peritoneal Drain) and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-operative diagnosis as covariates.||||0.03
91712757|NCT03442725|183317180|OTHER||Geometric Mean Ratio|1.828|||||TWO_SIDED|90.0|0.903|3.699||||||ANOVA comparison of AUC0-infu for LP-778902 between test group versus the control group.||3.699|0.903|
91712758|NCT03442725|183317181|OTHER||Geometric Mean Ratio|1.835|||||TWO_SIDED|90.0|0.904|3.726||||||ANOVA comparison of AUC0-tlastu for LP-778902 between test group versus the control group.||3.726|0.904|
91524400|NCT02799472|182923976|OTHER||Ratio|1.602||||0.216|TWO_SIDED|95.0|0.75|3.423|||Repeated measures analysis|||Interleukin 6, 12-Week FU||3.423|0.750|0.216
91617226|NCT04047121|183127524|SUPERIORITY||Odds Ratio (OR)|5.253||||0.0013|TWO_SIDED|95.0|1.9061|14.477|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||14.4770|1.9061|0.0013
91617227|NCT04047121|183127525|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
91617228|NCT04047121|183127525|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
91617229|NCT04047121|183127525|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
91617230|NCT04047121|183127525|SUPERIORITY||Odds Ratio (OR)|0.8593||||0.5368|TWO_SIDED|95.0|0.5311|1.3902|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3902|0.5311|0.5368
91617231|NCT04047121|183127525|SUPERIORITY||Odds Ratio (OR)|1.2892||||0.4685|TWO_SIDED|95.0|0.6488|2.5616|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.5616|0.6488|0.4685
91617232|NCT04047121|183127525|SUPERIORITY||Odds Ratio (OR)|1.3598||||0.3112|TWO_SIDED|95.0|0.7502|2.4648|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4648|0.7502|0.3112
91617233|NCT04047121|183127526|SUPERIORITY|||||||0.409|||||||Chi-squared|||||||0.4090
91617234|NCT04047121|183127526|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
91617235|NCT04047121|183127526|SUPERIORITY|||||||0.0103|||||||Chi-squared|||||||0.0103
91617236|NCT04047121|183127526|SUPERIORITY||Odds Ratio (OR)|1.1302||||0.5415|TWO_SIDED|95.0|0.763|1.6741|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6741|0.7630|0.5415
91617237|NCT04047121|183127526|SUPERIORITY||Odds Ratio (OR)|2.0118||||0.0596|TWO_SIDED|95.0|0.9722|4.1632|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.1632|0.9722|0.0596
91617238|NCT04047121|183127526|SUPERIORITY||Odds Ratio (OR)|3.4823||||0.0002|TWO_SIDED|95.0|1.793|6.7633|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.7633|1.7930|0.0002
91617239|NCT04047121|183127527|SUPERIORITY|||||||0.2361|||||||Chi-squared|||||||0.2361
91617240|NCT04047121|183127527|SUPERIORITY|||||||0.7474|||||||Chi-squared|||||||0.7474
91617241|NCT04047121|183127527|SUPERIORITY|||||||0.2118|||||||Chi-squared|||||||0.2118
91617242|NCT04047121|183127527|SUPERIORITY||Odds Ratio (OR)|1.3811||||0.1978|TWO_SIDED|95.0|0.8449|2.2576|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2576|0.8449|0.1978
91617243|NCT04047121|183127527|SUPERIORITY||Odds Ratio (OR)|1.0614||||0.8893|TWO_SIDED|95.0|0.4587|2.4559|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4559|0.4587|0.8893
91617244|NCT04047121|183127527|SUPERIORITY||Odds Ratio (OR)|0.5811||||0.1553|TWO_SIDED|95.0|0.2748|1.2286|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2286|0.2748|0.1553
91617245|NCT04047121|183127528|SUPERIORITY|||||||0.6767|||||||Chi-squared|||||||0.6767
91617246|NCT04047121|183127528|SUPERIORITY|||||||0.1141|||||||Chi-squared|||||||0.1141
91617247|NCT04047121|183127528|SUPERIORITY|||||||0.1497|||||||Chi-squared|||||||0.1497
91617248|NCT04047121|183127528|SUPERIORITY||Odds Ratio (OR)|0.8556||||0.5228|TWO_SIDED|95.0|0.5303|1.3804|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3804|0.5303|0.5228
91617249|NCT04047121|183127528|SUPERIORITY||Odds Ratio (OR)|2.5125||||0.0277|TWO_SIDED|95.0|1.1062|5.7063|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.7063|1.1062|0.0277
91617250|NCT04047121|183127528|SUPERIORITY||Odds Ratio (OR)|0.6993||||0.324|TWO_SIDED|95.0|0.3435|1.4236|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4236|0.3435|0.3240
91617251|NCT04047121|183127529|SUPERIORITY|||||||0.6318|||||||t-test, 2 sided|||||||0.6318
91617252|NCT04047121|183127529|SUPERIORITY|||||||0.3802|||||||t-test, 2 sided|||||||0.3802
91617253|NCT04047121|183127529|SUPERIORITY|||||||0.2424|||||||t-test, 2 sided|||||||0.2424
91617254|NCT04047121|183127529|SUPERIORITY||Odds Ratio (OR)|0.0347||||0.1753|TWO_SIDED|95.0|-0.0155|0.0848|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0848|-0.0155|0.1753
91617255|NCT04047121|183127529|SUPERIORITY||Odds Ratio (OR)|0.0194||||0.6114|TWO_SIDED|95.0|-0.0553|0.0941|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0941|-0.0553|0.6114
91617256|NCT04047121|183127529|SUPERIORITY||Odds Ratio (OR)|0.0345||||0.2977|TWO_SIDED|95.0|-0.0304|0.0993|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0993|-0.0304|0.2977
91617257|NCT04047121|183127530|SUPERIORITY|||||||0.1473|||||||t-test, 2 sided|||||||0.1473
91617258|NCT04047121|183127530|SUPERIORITY|||||||0.8747|||||||t-test, 2 sided|||||||0.8747
91617259|NCT04047121|183127530|SUPERIORITY|||||||0.5265|||||||t-test, 2 sided|||||||0.5265
91617260|NCT04047121|183127530|SUPERIORITY||Odds Ratio (OR)|-0.0457||||0.2522|TWO_SIDED|95.0|-0.1239|0.0325|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0325|-0.1239|0.2522
91617261|NCT04047121|183127530|SUPERIORITY||Odds Ratio (OR)|0.0278||||0.6701|TWO_SIDED|95.0|-0.1003|0.1559|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1559|-0.1003|0.6701
91657470|NCT01029353|183208399|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.82, 1.11).|||
91657471|NCT01029353|183208399|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.75|1.26|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariate.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) covariates.||1.26|0.75|
91657472|NCT01029353|183208400|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.69|1.45|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.45|0.69|
91657473|NCT01029353|183208400|SUPERIORITY|A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|||||||||||||||||Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.69, 1.30).|||
91657474|NCT01029353|183208401|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Estimate based on model fit using only data from study survivors.||1.34|0.78|
91657475|NCT01029353|183208401|SUPERIORITY|||||||||||||||||A Bayesian analysis among study survivors. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.99, 95% credible interval of (0.78, 1.25).|||
91657476|NCT01029353|183208402|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.66|1.06|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.06|0.66|
91657477|NCT01029353|183208402|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.65, 1.02).|||
91657478|NCT01029353|183208403|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.89|1.18|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.18|0.89|
91722426|NCT04390750|183337443|OTHER|The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 2 and Control at 3 months.|Interaction coefficient|-0.12||||0.132||95.0|-0.28|0.04|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the primary endpoint of 3 months.||0.04|-0.28|0.132
91617262|NCT04047121|183127530|SUPERIORITY||Odds Ratio (OR)|0.1693||||0.1017|TWO_SIDED|95.0|-0.0334|0.372|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3720|-0.0334|0.1017
91617263|NCT04047121|183127531|SUPERIORITY|||||||0.2246|||||||t-test, 2 sided|||||||0.2246
91617264|NCT04047121|183127531|SUPERIORITY|||||||0.2101|||||||t-test, 2 sided|||||||0.2101
91657479|NCT01029353|183208403|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.98, 95% credible interval of (0.84, 1.15).|||
91617265|NCT04047121|183127531|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.0030
91617266|NCT04047121|183127531|SUPERIORITY||Odds Ratio (OR)|0.414||||0.3324|TWO_SIDED|95.0|-0.4231|1.2511|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2511|-0.4231|0.3324
91617267|NCT04047121|183127531|SUPERIORITY||Odds Ratio (OR)|1.1712||||0.1367|TWO_SIDED|95.0|-0.3713|2.7138|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7138|-0.3713|0.1367
91617268|NCT04047121|183127531|SUPERIORITY||Odds Ratio (OR)|1.8099||||0.0028|TWO_SIDED|95.0|0.6219|2.9978|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9978|0.6219|0.0028
91617269|NCT04047121|183127532|SUPERIORITY|||||||0.2667|||||||t-test, 2 sided|||||||0.2667
91617270|NCT04047121|183127532|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||0.6570
91617271|NCT04047121|183127532|SUPERIORITY|||||||0.5403|||||||t-test, 2 sided|||||||0.5403
91617272|NCT04047121|183127532|SUPERIORITY||Odds Ratio (OR)|0.9159||||0.1167|TWO_SIDED|95.0|-0.2283|2.06|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.0600|-0.2283|0.1167
91617273|NCT04047121|183127532|SUPERIORITY||Odds Ratio (OR)|-0.0336||||0.9722|TWO_SIDED|95.0|-1.9238|1.8567|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.8567|-1.9238|0.9722
91617274|NCT04047121|183127532|SUPERIORITY||Odds Ratio (OR)|0.2064||||0.8455|TWO_SIDED|95.0|-1.8689|2.2817|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2817|-1.8689|0.8455
91617275|NCT04047121|183127533|SUPERIORITY|||||||0.3142|||||||t-test, 2 sided|||||||0.3142
91617276|NCT04047121|183127533|SUPERIORITY|||||||0.2465|||||||t-test, 2 sided|||||||0.2465
91617277|NCT04047121|183127533|SUPERIORITY|||||||0.5933|||||||t-test, 2 sided|||||||0.5933
91617278|NCT04047121|183127533|SUPERIORITY||Odds Ratio (OR)|-0.0089||||0.7815|TWO_SIDED|95.0|-0.0716|0.0538|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0538|-0.0716|0.7815
91617279|NCT04047121|183127533|SUPERIORITY||Odds Ratio (OR)|0.0337||||0.4446|TWO_SIDED|95.0|-0.0528|0.1202|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1202|-0.0528|0.4446
91617280|NCT04047121|183127533|SUPERIORITY||Odds Ratio (OR)|-0.0333||||0.4733|TWO_SIDED|95.0|-0.1243|0.0577|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0577|-0.1243|0.4733
91617281|NCT04047121|183127534|SUPERIORITY|||||||0.0658|||||||t-test, 2 sided|||||||0.0658
91617282|NCT04047121|183127534|SUPERIORITY|||||||0.3785|||||||t-test, 2 sided|||||||0.3785
91617283|NCT04047121|183127534|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
91617284|NCT04047121|183127534|SUPERIORITY||Odds Ratio (OR)|-0.0425||||0.2523|TWO_SIDED|95.0|-0.1154|0.0303|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0303|-0.1154|0.2523
91617285|NCT04047121|183127534|SUPERIORITY||Odds Ratio (OR)|-0.0388||||0.4068|TWO_SIDED|95.0|-0.1305|0.0529|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0529|-0.1305|0.4068
91617286|NCT04047121|183127534|SUPERIORITY||Odds Ratio (OR)|0.0706||||0.5858|TWO_SIDED|95.0|-0.1833|0.3244|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3244|-0.1833|0.5858
91617287|NCT04047121|183127535|SUPERIORITY|||||||0.3832|||||||t-test, 2 sided|||||||0.3832
91617288|NCT04047121|183127535|SUPERIORITY|||||||0.4631|||||||t-test, 2 sided|||||||0.4631
91617289|NCT04047121|183127535|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
91617290|NCT04047121|183127535|SUPERIORITY||Odds Ratio (OR)|-0.5353||||0.3158|TWO_SIDED|95.0|-1.5812|0.5107|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5107|-1.5812|0.3158
91617291|NCT04047121|183127535|SUPERIORITY||Odds Ratio (OR)|1.3543||||0.1016|TWO_SIDED|95.0|-0.2669|2.9755|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9755|-0.2669|0.1016
91617292|NCT04047121|183127535|SUPERIORITY||Odds Ratio (OR)|0.8677||||0.2576|TWO_SIDED|95.0|-0.6347|2.37|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3700|-0.6347|0.2576
91617293|NCT04047121|183127536|SUPERIORITY|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
91617294|NCT04047121|183127536|SUPERIORITY|||||||0.3735|||||||t-test, 2 sided|||||||0.3735
91617295|NCT04047121|183127536|SUPERIORITY|||||||0.3863|||||||t-test, 2 sided|||||||0.3863
91617296|NCT04047121|183127536|SUPERIORITY||Odds Ratio (OR)|-1.0337||||0.1918|TWO_SIDED|95.0|-2.5858|0.5184|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5184|-2.5858|0.1918
91617297|NCT04047121|183127536|SUPERIORITY||Odds Ratio (OR)|-0.9749||||0.4281|TWO_SIDED|95.0|-3.3864|1.4366|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4366|-3.3864|0.4281
91617298|NCT04047121|183127536|SUPERIORITY||Odds Ratio (OR)|-1.8599||||0.1014|TWO_SIDED|95.0|-4.0854|0.3657|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3657|-4.0854|0.1014
91617299|NCT04047121|183127537|SUPERIORITY|||||||0.4555|||||||t-test, 2 sided|||||||0.4555
91617300|NCT04047121|183127537|SUPERIORITY|||||||0.7164|||||||t-test, 2 sided|||||||0.7164
91617301|NCT04047121|183127537|SUPERIORITY|||||||0.2456|||||||t-test, 2 sided|||||||0.2456
91617302|NCT04047121|183127537|SUPERIORITY||Odds Ratio (OR)|0.0568||||0.0962|TWO_SIDED|95.0|-0.0101|0.1238|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1238|-0.0101|0.0962
91617303|NCT04047121|183127537|SUPERIORITY||Odds Ratio (OR)|-0.0432||||0.3844|TWO_SIDED|95.0|-0.1405|0.0541|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0541|-0.1405|0.3844
91617304|NCT04047121|183127537|SUPERIORITY||Odds Ratio (OR)|0.0233||||0.5899|TWO_SIDED|95.0|-0.0615|0.1082|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1082|-0.0615|0.5899
91617305|NCT04047121|183127538|SUPERIORITY|||||||0.4133|||||||t-test, 2 sided|||||||0.4133
91617306|NCT04047121|183127538|SUPERIORITY|||||||0.7171|||||||t-test, 2 sided|||||||0.7171
91617307|NCT04047121|183127538|SUPERIORITY|||||||0.8609|||||||t-test, 2 sided|||||||0.8609
91617308|NCT04047121|183127538|SUPERIORITY||Odds Ratio (OR)|-0.0445||||0.6224|TWO_SIDED|95.0|-0.2218|0.1327|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1327|-0.2218|0.6224
91617309|NCT04047121|183127538|SUPERIORITY||Odds Ratio (OR)|-0.0884||||0.5655|TWO_SIDED|95.0|-0.39|0.2132|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2132|-0.3900|0.5655
91617310|NCT04047121|183127538|SUPERIORITY||Odds Ratio (OR)|0.1809||||0.4044|TWO_SIDED|95.0|-0.2444|0.6062|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.6062|-0.2444|0.4044
91617311|NCT04047121|183127539|SUPERIORITY|||||||0.0104|||||||t-test, 2 sided|||||||0.0104
91617312|NCT04047121|183127539|SUPERIORITY|||||||0.5949|||||||t-test, 2 sided|||||||0.5949
91617313|NCT04047121|183127539|SUPERIORITY|||||||0.0801|||||||t-test, 2 sided|||||||0.0801
91617314|NCT04047121|183127539|SUPERIORITY||Odds Ratio (OR)|-3.7075||||0.0072|TWO_SIDED|95.0|-6.411|-1.004|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-1.0040|-6.4110|0.0072
91617315|NCT04047121|183127539|SUPERIORITY||Odds Ratio (OR)|-1.4296||||0.5406|TWO_SIDED|95.0|-6.008|3.1489|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1489|-6.0080|0.5406
91617316|NCT04047121|183127539|SUPERIORITY||Odds Ratio (OR)|-0.3527||||0.8603|TWO_SIDED|95.0|-4.279|3.5737|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.5737|-4.2790|0.8603
91617317|NCT04047121|183127540|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||||||0.6344
91617318|NCT04047121|183127540|SUPERIORITY|||||||0.3037|||||||t-test, 2 sided|||||||0.3037
91617319|NCT04047121|183127540|SUPERIORITY|||||||0.1344|||||||t-test, 2 sided|||||||0.1344
91617320|NCT04047121|183127540|SUPERIORITY||Odds Ratio (OR)|1.2586||||0.5092|TWO_SIDED|95.0|-2.4787|4.9958|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.9958|-2.4787|0.5092
91617321|NCT04047121|183127540|SUPERIORITY||Odds Ratio (OR)|-0.7696||||0.8047|TWO_SIDED|95.0|-6.8683|5.3292|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.3292|-6.8683|0.8047
91617322|NCT04047121|183127540|SUPERIORITY||Odds Ratio (OR)|0.094||||0.9757|TWO_SIDED|95.0|-5.9628|6.1507|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.1507|-5.9628|0.9757
91617323|NCT04047121|183127541|SUPERIORITY|||||||0.0839|||||||t-test, 2 sided|||||||0.0839
91617324|NCT04047121|183127541|SUPERIORITY|||||||0.9577|||||||t-test, 2 sided|||||||0.9577
91617325|NCT04047121|183127541|SUPERIORITY|||||||0.9497|||||||t-test, 2 sided|||||||0.9497
91657480|NCT01029353|183208404|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.31|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.31|0.64|
91722427|NCT04390750|183337444|OTHER|The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 1 and Control at 6 months.|Interaction coefficient|-0.05||||0.402|TWO_SIDED|95.0|-0.16|0.06|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the secondary endpoint of 6 months.||0.06|-0.16|0.402
91524401|NCT02799472|182923976|OTHER||Ratio|0.926||||0.195|TWO_SIDED|95.0|0.823|1.042|||Repeated measures analysis|||MDC, Week 1||1.042|0.823|0.195
91617326|NCT04047121|183127541|SUPERIORITY||Odds Ratio (OR)|-0.031||||0.4873|TWO_SIDED|95.0|-0.1185|0.0565|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0565|-0.1185|0.4873
91617327|NCT04047121|183127541|SUPERIORITY||Odds Ratio (OR)|-0.0312||||0.678|TWO_SIDED|95.0|-0.1783|0.1159|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1159|-0.1783|0.6780
91617328|NCT04047121|183127541|SUPERIORITY||Odds Ratio (OR)|0.0099||||0.9327|TWO_SIDED|95.0|-0.2207|0.2406|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2406|-0.2207|0.9327
91617329|NCT04047121|183127542|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
91617330|NCT04047121|183127542|SUPERIORITY|||||||0.5396|||||||t-test, 2 sided|||||||0.5396
91617331|NCT04047121|183127542|SUPERIORITY|||||||0.6121|||||||t-test, 2 sided|||||||0.6121
91617332|NCT04047121|183127542|SUPERIORITY||Odds Ratio (OR)|-0.1895||||0.0303|TWO_SIDED|95.0|-0.361|-0.0181|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-0.0181|-0.3610|0.0303
91617333|NCT04047121|183127542|SUPERIORITY||Odds Ratio (OR)|-0.1901||||0.1807|TWO_SIDED|95.0|-0.4685|0.0883|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0883|-0.4685|0.1807
91617334|NCT04047121|183127542|SUPERIORITY||Odds Ratio (OR)|0.1594||||0.7445|TWO_SIDED|95.0|-0.7991|1.1178|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1178|-0.7991|0.7445
91617335|NCT04047121|183127543|SUPERIORITY|||||||0.0035|||||||t-test, 2 sided|||||||0.0035
91617336|NCT04047121|183127543|SUPERIORITY|||||||0.504|||||||t-test, 2 sided|||||||0.5040
91617337|NCT04047121|183127543|SUPERIORITY|||||||0.1366|||||||t-test, 2 sided|||||||0.1366
91617338|NCT04047121|183127543|SUPERIORITY||Odds Ratio (OR)|-3.4084||||0.082|TWO_SIDED|95.0|-7.2497|0.433|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.4330|-7.2497|0.0820
91617339|NCT04047121|183127543|SUPERIORITY||Odds Ratio (OR)|-1.5342||||0.5845|TWO_SIDED|95.0|-7.0336|3.9652|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.9652|-7.0336|0.5845
91617340|NCT04047121|183127543|SUPERIORITY||Odds Ratio (OR)|0.987||||0.7284|TWO_SIDED|95.0|-4.583|6.557|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.5570|-4.5830|0.7284
91617341|NCT04047121|183127544|SUPERIORITY|||||||0.1125|||||||t-test, 2 sided|||||||0.1125
91617342|NCT04047121|183127544|SUPERIORITY|||||||0.7156|||||||t-test, 2 sided|||||||0.7156
91617343|NCT04047121|183127544|SUPERIORITY|||||||0.2056|||||||t-test, 2 sided|||||||0.2056
91617344|NCT04047121|183127544|SUPERIORITY||Odds Ratio (OR)|-1.8061||||0.4288|TWO_SIDED|95.0|-6.2797|2.6675|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.6675|-6.2797|0.4288
91617345|NCT04047121|183127544|SUPERIORITY||Odds Ratio (OR)|-1.6946||||0.6303|TWO_SIDED|95.0|-8.5962|5.2069|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.2069|-8.5962|0.6303
91617346|NCT04047121|183127544|SUPERIORITY||Odds Ratio (OR)|-0.9873||||0.7477|TWO_SIDED|95.0|-7.0028|5.0281|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.0281|-7.0028|0.7477
91617347|NCT04047121|183127545|SUPERIORITY|||||||0.3919|||||||t-test, 2 sided|||||||0.3919
91617348|NCT04047121|183127545|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91617349|NCT04047121|183127545|SUPERIORITY|||||||0.0193|||||||t-test, 2 sided|||||||0.0193
91657481|NCT01029353|183208404|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.86, 95% credible interval of (0.64, 1.16).|||
91657482|NCT01029353|183208405|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.69|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.69|
91657483|NCT01029353|183208405|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.92, 95% credible interval of (0.68, 1.25).|||
91657484|NCT01029353|183208406|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.35|0.63|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.63|0.35|
91657485|NCT01029353|183208406|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.51, 95% credible interval of (0.37, 0.69).|||
91657486|NCT01029353|183208407|SUPERIORITY||Risk Ratio (RR)|1.57|||||TWO_SIDED|95.0|1.04|2.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.36|1.04|
91657487|NCT01029353|183208407|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.45, 95% credible interval of (0.92, 2.31).|||
91657488|NCT01029353|183208408|SUPERIORITY||Risk Ratio (RR)|1.58|||||TWO_SIDED|95.0|0.71|3.5|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||3.50|0.71|
91712759|NCT02603211|183317221|OTHER||||||||||||||||||"We will obtain 20 tactile image data sets from the breast tumor patients. The tactile images will be converted to size and deformation index. Then these two parameters will be converted to the risk score. This is a small number of patients for statistically significance study. Therefore, we plan to use the Leave-One-Out-Cross-Validation (LOOCV) technique to validate the human test results to determine the performance of the device.~We obtain the Risk Score. Risk Score is a unit less numerical value, which can be used as a scale to classify the tumor as malignant and benign. Based on the calculated size of the tumor and measured deformation index, the breast tumors are classified as benign and malignant using scoring method. The risk score will range from 0 to 5, where 0 represents the benign and 5 represents the malignant tumor.~Comparing the Risk Score and the Pathology reports we obtain sensitivity, specificity and accuracy of the system."|||
91712760|NCT00758498|183317226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.07|3.71|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||3.71|2.07|<0.0001
91712761|NCT00758498|183317226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9|||<|0.0001|TWO_SIDED|95.0|6.06|7.69|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||7.69|6.06|<0.0001
91712762|NCT00758498|183317227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8341|TWO_SIDED|95.0|-0.2|0.25|||ANOVA|||||0.25|-0.20|0.8341
91712763|NCT00758498|183317227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0441|TWO_SIDED|95.0|-0.5|-0.05|||ANCOVA|||||-0.05|-0.50|0.0441
91712764|NCT00758498|183317228|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91524402|NCT02799472|182923976|OTHER||Ratio|0.984||||0.851|TWO_SIDED|95.0|0.829|1.168|||Repeated measures analysis|||MDC, Week 2||1.168|0.829|0.851
91617350|NCT04047121|183127545|SUPERIORITY||Cost Ratio|1.2232||||0.057|TWO_SIDED|95.0|0.994|1.5053|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5053|0.9940|0.0570
91617351|NCT04047121|183127545|SUPERIORITY||Cost Ratio|1.8479|||<|0.0001|TWO_SIDED|95.0|1.4378|2.3749|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3749|1.4378|<0.0001
91617352|NCT04047121|183127545|SUPERIORITY||Cost Ratio|1.1868||||0.0924|TWO_SIDED|95.0|0.9722|1.4487|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4487|0.9722|0.0924
91617353|NCT04047121|183127546|SUPERIORITY|||||||0.6184|||||||t-test, 2 sided|||||||0.6184
91617354|NCT04047121|183127546|SUPERIORITY|||||||0.1952|||||||t-test, 2 sided|||||||0.1952
91617355|NCT04047121|183127546|SUPERIORITY|||||||0.1638|||||||t-test, 2 sided|||||||0.1638
91617356|NCT04047121|183127546|SUPERIORITY||Cost Ratio|0.9773||||0.6732|TWO_SIDED|95.0|0.8782|1.0875|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0875|0.8782|0.6732
91617357|NCT04047121|183127546|SUPERIORITY||Cost Ratio|0.9629||||0.6345|TWO_SIDED|95.0|0.824|1.1253|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1253|0.8240|0.6345
91617358|NCT04047121|183127546|SUPERIORITY||Cost Ratio|0.8327||||0.0029|TWO_SIDED|95.0|0.738|0.9395|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9395|0.7380|0.0029
91617359|NCT04047121|183127547|SUPERIORITY|||||||0.3087|||||||t-test, 2 sided|||||||0.3087
91617360|NCT04047121|183127547|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
91617361|NCT04047121|183127547|SUPERIORITY|||||||0.0647|||||||t-test, 2 sided|||||||0.0647
91617362|NCT04047121|183127547|SUPERIORITY||Cost Ratio|0.9762||||0.7684|TWO_SIDED|95.0|0.8316|1.146|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1460|0.8316|0.7684
91617363|NCT04047121|183127547|SUPERIORITY||Cost Ratio|1.3862||||0.0012|TWO_SIDED|95.0|1.1379|1.6886|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6886|1.1379|0.0012
91617364|NCT04047121|183127547|SUPERIORITY||Cost Ratio|1.0065||||0.9422|TWO_SIDED|95.0|0.8452|1.1985|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1985|0.8452|0.9422
91617365|NCT04047121|183127548|SUPERIORITY|||||||0.0421|||||||t-test, 2 sided|||||||0.0421
91617366|NCT04047121|183127548|SUPERIORITY|||||||0.8137|||||||t-test, 2 sided|||||||0.8137
91617367|NCT04047121|183127548|SUPERIORITY|||||||0.9416|||||||t-test, 2 sided|||||||0.9416
91617368|NCT04047121|183127548|SUPERIORITY||Cost Ratio|0.9515||||0.319|TWO_SIDED|95.0|0.8628|1.0493|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0493|0.8628|0.3190
91657489|NCT01029353|183208408|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.31, 95% credible interval of (0.66, 2.62).|||
91712765|NCT00758498|183317228|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91712766|NCT00758498|183317229|SUPERIORITY_OR_OTHER|||||||0.0012|||||||ANCOVA|Treatment comparisons made use of an analysis of covariance (ANCOVA) analysis with treatment as a factor and baseline value as a covariate||||||0.0012
91617369|NCT04047121|183127548|SUPERIORITY||Cost Ratio|0.8991||||0.1368|TWO_SIDED|95.0|0.7815|1.0343|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0343|0.7815|0.1368
91617370|NCT04047121|183127548|SUPERIORITY||Cost Ratio|0.8514||||0.0231|TWO_SIDED|95.0|0.7411|0.9782|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9782|0.7411|0.0231
91617371|NCT02604810|183127554|NON_INFERIORITY|Method of estimation = least-squares means based on analysis of variance (ANOVA) with a mixed-effect model. The lower bound of the 90% confidence interval (CI) for the geometric LSM ratio (SC/IV) of the primary PK endpoint of steady state AUC0-7 days for the PK population should be above 0.80.|Geometric least-squares mean ratio|1.04|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
91617372|NCT03696758|183127566|OTHER|Descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
91617373|NCT03696758|183127567|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
91617374|NCT03696758|183127568|OTHER|descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
91617375|NCT03696758|183127569|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.1
91617376|NCT03696758|183127570|OTHER|Descriptive statistics||||||0.09||||||p value is 0.09 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.09
91617377|NCT03696758|183127571|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.10
91617378|NCT03696758|183127572|OTHER|Descriptive statistics||||||0.82||||||p value is 0.82 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.82
91617379|NCT03696758|183127573|OTHER|Descriptive statistics||||||0.3||||||p value is 0.30 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.30
91617380|NCT03696758|183127574|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
91617381|NCT03696758|183127575|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
91617382|NCT03696758|183127576|OTHER|Descriptive statistics||||||0.65||||||P-Value is 0.65 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.65
91712767|NCT00758498|183317229|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis by ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
91712768|NCT00758498|183317230|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Analysis of treatment comparisons is based on an analysis of variance (ANCOVA) with treatment as a factor and the baseline value as covariate|ANCOVA|||||||<0.0001
91617383|NCT03696758|183127577|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
91617384|NCT03696758|183127578|OTHER|Descriptive statistics||||||0.43||||||P-Value is 0.43 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.43
91617385|NCT03696758|183127579|OTHER|Descriptive statistics||||||0.66||||||P-Value is 0.66 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.66
91617386|NCT03696758|183127580|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
91617387|NCT03696758|183127581|OTHER|Descriptive statistics||||||0.57||||||P-Value is 0.57 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.57
91617388|NCT03696758|183127582|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
91617389|NCT03696758|183127583|OTHER|Descriptive statistics||||||0.07||||||P-Value is 0.07 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.07
91617390|NCT03696758|183127584|OTHER|Descriptive statistics||||||0.36||||||P-Value is 0.36 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.36
91617391|NCT03696758|183127585|OTHER|Descriptive statistics||||||0.91||||||P-Value is 0.91 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.91
91617392|NCT03207022|183127601|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91617393|NCT03207022|183127602|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91617394|NCT03207022|183127603|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91617395|NCT06150573|183127604|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.498||0.9141|TWO_SIDED|95.0|-1.04|0.93|||ANOVA|||||0.93|-1.04|0.9141
91617396|NCT06150573|183127605|SUPERIORITY||Adjusted Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.494||0.4583|TWO_SIDED|95.0|-0.61|1.34|||ANOVA|||||1.34|-0.61|0.4583
91617397|NCT06150573|183127606|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0042|TWO_SIDED|95.0|-0.3|-0.06|||ANOVA|||Week 12||-0.06|-0.30|0.0042
91617398|NCT06150573|183127606|SUPERIORITY||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.46|-0.17|||ANOVA|||Week 24||-0.17|-0.46|<0.0001
91617399|NCT06150573|183127607|SUPERIORITY||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.016||0.2478|TWO_SIDED|95.0|-0.05|0.01|||ANOVA|||Mean Gingival MLSI, Week 12||0.01|-0.05|0.2478
91617400|NCT06150573|183127607|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.0957|TWO_SIDED|95.0|-0.07|0.01|||ANOVA|||Mean Gingival MLSI, Week 24||0.01|-0.07|0.0957
91617401|NCT06150573|183127607|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.122||0.0063|TWO_SIDED|95.0|-0.58|-0.1|||ANOVA|||Mean Interproximal MLSI, Week 12||-0.10|-0.58|0.0063
91712769|NCT00758498|183317230|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on an ANCOVA with treatment as a factor and baseline value as a covariate||||||<0.0001
91617402|NCT06150573|183127607|SUPERIORITY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-0.89|-0.31|||ANOVA|||Mean Interproximal MLSI, Week 24||-0.31|-0.89|<0.0001
91617403|NCT06150573|183127607|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.1536|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|||Mean Body MLSI, Week 12||0.01|-0.03|0.1536
91617404|NCT06150573|183127607|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006||0.1166|TWO_SIDED|95.0|-0.02|0.0|||ANOVA|||Mean Body MLSI, Week 24||0.00|-0.02|0.1166
91617405|NCT06150573|183127608|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.21|-0.07|||ANOVA|||Week 12||-0.07|-0.21|<0.0001
91617406|NCT06150573|183127608|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|-0.25|-0.1|||ANOVA|||Week 24||-0.10|-0.25|<0.0001
91617407|NCT06150573|183127609|SUPERIORITY||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.04|TWO_SIDED|95.0|-0.13|0.0|||ANOVA|||Week 12||-0.00|-0.13|0.0400
91617408|NCT06150573|183127609|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.001|TWO_SIDED|95.0|-0.2|-0.05|||ANOVA|||Week 24||-0.05|-0.20|0.0010
91617409|NCT00210158|183127610|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.5|TWO_SIDED|95.0|-23.4|42.8|||t-test, 2 sided|||T-test for a difference of means, assuming independant samples and unequal variances||42.8|-23.4|0.5
91617410|NCT04096326|183127639|SUPERIORITY||Rate difference|40.6||||0.0096|TWO_SIDED|95.0|23.6|57.6||P-value was based on Cochran-Mantel-Haenszel (CMH) tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||57.6|23.6|0.0096
91617411|NCT04096326|183127639|SUPERIORITY||Rate difference|46.4||||0.0094|TWO_SIDED|95.0|28.0|64.9||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||64.9|28.0|0.0094
91617412|NCT04096326|183127639|SUPERIORITY||Rate difference|52.2||||0.0044|TWO_SIDED|95.0|23.6|80.8||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||80.8|23.6|0.0044
91617413|NCT04096326|183127639|SUPERIORITY||Rate difference|63.3||||0.0026|TWO_SIDED|95.0|35.2|91.5||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||91.5|35.2|0.0026
91617414|NCT04096326|183127639|SUPERIORITY||Rate difference|85.7||||0|TWO_SIDED|95.0|64.2|100.0||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||100.0|64.2|0.0000
91617415|NCT04804033|183127645|OTHER||Difference in least square mean (LSM)|-1.4|||||TWO_SIDED|97.5|-2.72|-0.12|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.12|-2.72|
91617416|NCT04804033|183127645|OTHER||Difference in LSM|-0.7|||||TWO_SIDED|97.5|-2.07|0.69|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.69|-2.07|
91617417|NCT04804033|183127646|OTHER||Difference in percentage|16.6|||||TWO_SIDED|97.5|4.4|28.8|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||28.8|4.4|
91617418|NCT04804033|183127646|OTHER||Difference in percentage|6.6|||||TWO_SIDED|97.5|-5.6|18.9|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||18.9|-5.6|
91617419|NCT04804033|183127647|OTHER||Difference in LSM|-1.0|||||TWO_SIDED|97.5|-2.68|0.58|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.58|-2.68|
91617420|NCT04804033|183127647|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|97.5|-2.1|1.31|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||1.31|-2.10|
91617421|NCT04804033|183127648|OTHER||Difference in LSM|-1.8|||||TWO_SIDED|97.5|-3.16|-0.42|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.42|-3.16|
91617422|NCT04804033|183127648|OTHER||Difference in LSM|-1.2|||||TWO_SIDED|97.5|-2.53|0.22|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.22|-2.53|
91617423|NCT04804033|183127649|OTHER||Difference in LSM|-0.8|||||TWO_SIDED|97.5|-1.59|0.05|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.05|-1.59|
91617424|NCT04804033|183127649|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|97.5|-1.06|0.74|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.74|-1.06|
91617425|NCT04804033|183127650|OTHER||Difference in LSM|3.9|||||TWO_SIDED|97.5|-1.5|9.39|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||9.39|-1.50|
91617426|NCT04804033|183127650|OTHER||Difference in LSM|0.1|||||TWO_SIDED|97.5|-5.66|5.86|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||5.86|-5.66|
91617427|NCT04804033|183127651|OTHER||Difference in LSM|-9.0|||||TWO_SIDED|97.5|-18.1|0.19|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.19|-18.10|
91617428|NCT04804033|183127651|OTHER||Difference in LSM|-9.3|||||TWO_SIDED|97.5|-18.95|0.41|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.41|-18.95|
91712770|NCT00758498|183317231|SUPERIORITY_OR_OTHER|||||||0.0022|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||0.0022
91617429|NCT04490265|183127676|SUPERIORITY||Cohen's d|0.33|||||TWO_SIDED|||||||||||||
91617430|NCT04490265|183127677|SUPERIORITY||Cohen's d|0.78|||||TWO_SIDED|||||||||||||
91617431|NCT04490265|183127682|SUPERIORITY||Cohen's d|0.14|||||TWO_SIDED|||||||||Belonging Subscale change from baseline to 12-weeks||||
91712771|NCT00758498|183317231|SUPERIORITY_OR_OTHER|||||||0.0033|||||||ANCOVA|Analysis of treatment comparisons was based on ANCOVA with treatment as a factor and the baseline as a covariate||||||0.0033
91712772|NCT00758498|183317237|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as factor and baseline value as a covariate.||||||<0.0001
91712773|NCT00758498|183317237|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as factor and baseline value as a covariate||||||<0.0001
91617432|NCT04490265|183127682|SUPERIORITY||Cohen's D|0.05|||||TWO_SIDED|||||||||Belonging subscale Baseline to 6-months||||
91617433|NCT04490265|183127682|SUPERIORITY||Cohen's D|0.6|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 12-weeks||||
91617434|NCT04490265|183127682|SUPERIORITY||Cohen's D|0.43|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 6 months||||
91617435|NCT04490265|183127683|SUPERIORITY||Cohen's D|0.07|||||TWO_SIDED|||||||||Baseline to 12-weeks||||
91617436|NCT04490265|183127683|SUPERIORITY||Cohen's D|0.13|||||TWO_SIDED|||||||||Baseline to 6-months||||
91617437|NCT04490265|183127684|SUPERIORITY||Cohen's d|0.6|||||TWO_SIDED|||||||||||||
91617438|NCT04490265|183127685|SUPERIORITY||Cohen's d|0.52|||||TWO_SIDED|||||||||||||
91617439|NCT04490265|183127686|SUPERIORITY||Cohen's d|0.21|||||TWO_SIDED|||||||||||||
91617440|NCT04490265|183127687|SUPERIORITY||Cohen's d|0.2|||||TWO_SIDED|||||||||||||
91617441|NCT04490265|183127688|SUPERIORITY||Cohen's d|0.66|||||TWO_SIDED|||||||||||||
91617442|NCT04490265|183127689|SUPERIORITY||cohen's d|0.38|||||TWO_SIDED|||||||||||||
91617443|NCT04490265|183127690|SUPERIORITY||Cohens d|0.47|||||TWO_SIDED|||||||||Severity||||
91617444|NCT04490265|183127690|SUPERIORITY||Cohens d|0.46|||||TWO_SIDED|||||||||interference||||
91617445|NCT04490265|183127691|SUPERIORITY||Cohens d|0.64|||||TWO_SIDED|||||||||Severity Subscale||||
91617446|NCT04490265|183127691|SUPERIORITY||Cohen's d|0.38|||||TWO_SIDED|||||||||Interference subscale||||
91617447|NCT03280550|183127711|SUPERIORITY||Difference in Least Squares Means|-1.14|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.59|-0.69||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.69|-1.59|<0.0001
91657490|NCT01029353|183208409|SUPERIORITY|||||||||||||||||A frequentist analysis.|This analysis used model identical to other by treatment analyses for binary outcome. RR estimated from robust Poisson regression with log link, reference cell coding, center as repeated measure. RR: Initial Laparotomy over Peritoneal Drain. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates. However, adjusted RR estimates could not be calculated due to the iteration limit being excessed in PROC GENMOD.|||
91657491|NCT01029353|183208409|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.16, 95% credible interval of (0.50, 2.65).|||
91657492|NCT01029353|183208410|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.20|0.34|
91617448|NCT03280550|183127712|SUPERIORITY||Difference in Least Squares Means|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.84|-0.25||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.25|-0.84|0.0004
91617449|NCT03280550|183127713|SUPERIORITY||Difference in Least Squares Means|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.0161|TWO_SIDED|95.0|-0.6|-0.06||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.06|-0.60|0.0161
91617450|NCT03280550|183127714|SUPERIORITY||Difference in Least Squares Means|-0.56|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.84|-0.28||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.28|-0.84|0.0001
91617451|NCT03280550|183127715|SUPERIORITY||Difference in Least Squares Means|-1.01|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.43|-0.6||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.60|-1.43|<0.0001
91657493|NCT01029353|183208410|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.93, 95% credible interval of (0.45, 1.91).|||
91657494|NCT01029353|183208411|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.37|1.42|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.42|0.37|
91657495|NCT01029353|183208411|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.75, 95% credible interval of (0.48, 1.16).|||
91657496|NCT01029353|183208412|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.15|0.70|
91712774|NCT00758498|183317238|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||<0.0001
91524403|NCT02799472|182923976|OTHER||Ratio|0.956||||0.637|TWO_SIDED|95.0|0.79|1.158|||Repeated measures analysis|||MDC, Week 4||1.158|0.790|0.637
91617452|NCT03280550|183127716|SUPERIORITY||Difference in Least Squares Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.31||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.31|-0.83|<0.0001
91712775|NCT00758498|183317238|SUPERIORITY_OR_OTHER||Least square mean||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
91712776|NCT00758498|183317239|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||||<0.0001
91712777|NCT00758498|183317239|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is from an ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
91712778|NCT00758498|183317241|SUPERIORITY_OR_OTHER|||||||0.8262|||||||ANOVA|||||||0.8262
91712779|NCT00758498|183317241|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||||||0.0040
91712780|NCT00758498|183317242|SUPERIORITY_OR_OTHER|||||||0.9595|||||||ANOVA|||||||0.9595
91524404|NCT02799472|182923976|OTHER||Ratio|1.01||||0.915|TWO_SIDED|95.0|0.833|1.225|||Repeated measures analysis|||MDC, Week 6||1.225|0.833|0.915
91524405|NCT02799472|182923976|OTHER||Ratio|0.857||||0.157|TWO_SIDED|95.0|0.69|1.064|||Repeated measures analysis|||MDC, Week 8||1.064|0.690|0.157
91617453|NCT03280550|183127717|SUPERIORITY||Difference in Least Squares Means|-16.12|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-21.86|-10.38||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-10.38|-21.86|<0.0001
91617454|NCT03280550|183127718|SUPERIORITY||Difference in Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.16|-0.70|0.0023
91617455|NCT03280550|183127719|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||5.51|0.05|0.6716
91617456|NCT03280550|183127720|SUPERIORITY||Odds Ratio (OR)|0.0||||0.4815|TWO_SIDED|95.0|0.0|17.64||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||17.64|0.00|0.4815
91617457|NCT03280550|183127721|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0492|TWO_SIDED|95.0|1.0|13.71|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||13.71|1.00|0.0492
91617458|NCT03280550|183127722|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||5.51|0.05|0.6716
91617459|NCT03280550|183127723|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0209|TWO_SIDED|95.0|1.32|29.6||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||29.60|1.32|0.0209
91617460|NCT03280550|183127724|SUPERIORITY||Difference in Least Squares Means|-1.91|STANDARD_ERROR_OF_MEAN|0.48||0.0001|TWO_SIDED|95.0|-2.85|-0.96||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-0.96|-2.85|0.0001
91617461|NCT03280550|183127725|SUPERIORITY||Difference in Least Squares Means|3.81|STANDARD_ERROR_OF_MEAN|1.23||0.0024|TWO_SIDED|95.0|1.38|6.24||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.24|1.38|0.0024
91617462|NCT05896761|183127734|OTHER||Ratio of geometric least square mean|0.926|||||TWO_SIDED|90.0|0.831|1.03||||||||1.03|0.831|
91617463|NCT05896761|183127734|OTHER||Ratio of geometric least square mean|0.929|||||TWO_SIDED|90.0|0.816|1.06||||||||1.06|0.816|
91657497|NCT01029353|183208412|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.91, 95% credible interval of (0.65, 1.27).|||
91712781|NCT00758498|183317242|SUPERIORITY_OR_OTHER||Least square mean|||||0.3539|||||||ANOVA|||||||0.3539
91712782|NCT00758498|183317243|SUPERIORITY_OR_OTHER|||||||0.1038|||||||ANOVA|||||||0.1038
91617464|NCT05896761|183127735|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.966|1.17||||||||1.17|0.966|
91617465|NCT05896761|183127735|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.07|1.29||||||||1.29|1.07|
91617466|NCT05896761|183127736|OTHER||Ratio of geometric least square mean|1.35|||||TWO_SIDED|90.0|1.22|1.49||||||||1.49|1.22|
91617467|NCT05896761|183127736|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.975|1.24||||||||1.24|0.975|
91712783|NCT00758498|183317243|SUPERIORITY_OR_OTHER|||||||0.8112|||||||ANOVA|||||||0.8112
91712784|NCT01516736|183317252|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
91617468|NCT05896761|183127737|OTHER||Ratio of geometric least square mean|1.26|||||TWO_SIDED|90.0|1.12|1.4||||||||1.40|1.12|
91617469|NCT05896761|183127737|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.09|1.28||||||||1.28|1.09|
91617470|NCT05896761|183127738|OTHER||Ratio of geometric least square mean|1.21|||||TWO_SIDED|90.0|1.13|1.3||||||||1.30|1.13|
91617471|NCT05896761|183127738|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|1.0|1.2||||||||1.20|1.00|
91617472|NCT05896761|183127739|OTHER||Ratio of geometric least square mean|1.15|||||TWO_SIDED|90.0|1.07|1.23||||||||1.23|1.07|
91617473|NCT05896761|183127739|OTHER||Ratio of geometric least square mean|1.29|||||TWO_SIDED|90.0|1.2|1.38||||||||1.38|1.20|
91617474|NCT05896761|183127740|OTHER||Ratio of geometric least square mean|1.16|||||TWO_SIDED|90.0|1.08|1.25||||||||1.25|1.08|
91617475|NCT05896761|183127740|OTHER||Ratio of geometric least square mean|0.983|||||TWO_SIDED|90.0|0.89|1.09||||||||1.09|0.890|
91617476|NCT05896761|183127741|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.991|1.13||||||||1.13|0.991|
91617477|NCT05896761|183127741|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.974|1.12||||||||1.12|0.974|
91617478|NCT05896761|183127742|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.11|1.25||||||||1.25|1.11|
91617479|NCT05896761|183127742|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.989|1.14||||||||1.14|0.989|
91617480|NCT05896761|183127743|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|1.03|1.12||||||||1.12|1.03|
91617481|NCT05896761|183127743|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.997|1.08||||||||1.08|0.997|
91617482|NCT05896761|183127744|OTHER||Ratio of geometric least square mean|1.13|||||TWO_SIDED|90.0|1.08|1.19||||||||1.19|1.08|
91617483|NCT05896761|183127744|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.97|1.11||||||||1.11|0.97|
91617484|NCT05896761|183127745|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.02|1.11||||||||1.11|1.02|
91617485|NCT05896761|183127745|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.01|1.11||||||||1.11|1.01|
91617486|NCT01318083|183127768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.936|||||TWO_SIDED|95.0|-1.097|-0.775||||||||-0.775|-1.097|
91617487|NCT01318083|183127768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.998|||||TWO_SIDED|95.0|-1.16|-0.837||||||||-0.837|-1.160|
91617488|NCT01318083|183127769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.196|||||TWO_SIDED|95.0|-0.261|-0.131||||||||-0.131|-0.261|
91617489|NCT01318083|183127769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|||||TWO_SIDED|95.0|-0.273|-0.154||||||||-0.154|-0.273|
91617490|NCT01318083|183127770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.507|-0.312||||||||-0.312|-0.507|
91617491|NCT01318083|183127770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.453|||||TWO_SIDED|95.0|-0.547|-0.358||||||||-0.358|-0.547|
91617492|NCT01318083|183127771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.834|-0.556||||||||-0.556|-0.834|
91617493|NCT01318083|183127771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-0.911|-0.629||||||||-0.629|-0.911|
91617494|NCT01318083|183127772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.71|||||TWO_SIDED|95.0|-24.6|-10.83||||||||-10.83|-24.60|
91617495|NCT01318083|183127772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.59|||||TWO_SIDED|95.0|-24.93|-10.25||||||||-10.25|-24.93|
91617496|NCT01318083|183127773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.17|||||TWO_SIDED|95.0|-30.33|-16.02||||||||-16.02|-30.33|
91617497|NCT01318083|183127773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.88|||||TWO_SIDED|95.0|-32.33|-17.43||||||||-17.43|-32.33|
91617498|NCT01318083|183127774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.62|||||TWO_SIDED|95.0|-35.32|-19.91||||||||-19.91|-35.32|
91617499|NCT01318083|183127774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.72|||||TWO_SIDED|95.0|-30.76|-14.69||||||||-14.69|-30.76|
91617500|NCT01318083|183127775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.37|||||TWO_SIDED|95.0|-37.14|-19.59||||||||-19.59|-37.14|
91617501|NCT01318083|183127775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.93|||||TWO_SIDED|95.0|-30.33|-13.54||||||||-13.54|-30.33|
91617502|NCT01318083|183127776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.41|||||TWO_SIDED|95.0|-36.58|-10.23||||||||-10.23|-36.58|
91617503|NCT01318083|183127776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.18|||||TWO_SIDED|95.0|-33.4|-4.95||||||||-4.95|-33.40|
91617504|NCT03552549|183127793|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.77|||||Hazard ratio presented as PEG-Intron/INTRON A; HR \<1 indicates treatment effect in favor of PEG-Intron.|||1.77|0.28|
91617505|NCT02094586|183127802|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.08||||||Lot A vs. Lot B||1.08|0.78|
91617506|NCT02094586|183127807|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.2||||||Lot B vs Lot C||1.20|0.87|
91617507|NCT02094586|183127808|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||Lot A vs. Lot C||1.10|0.80|
91617508|NCT02761993|183127815|SUPERIORITY|||||||0.341||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equation|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.341
91617509|NCT02761993|183127815|SUPERIORITY|||||||0.774||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.774
91617510|NCT02761993|183127816|SUPERIORITY|||||||0.501||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.501
91617511|NCT02761993|183127816|SUPERIORITY|||||||0.486||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.486
91617512|NCT02761993|183127817|SUPERIORITY|||||||0.816|||||||ANCOVA|||||||0.816
91617513|NCT02761993|183127817|SUPERIORITY|||||||0.706|||||||ANCOVA|||||||0.706
91617514|NCT00256867|183127818|SUPERIORITY_OR_OTHER||Ratio Expressed as percent difference|-37.186|||<|0.0001|TWO_SIDED|95.0|-41.219|-32.879|||ANCOVA||Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use|||-32.879|-41.219|<0.0001
91617515|NCT00256867|183127819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.55|||ANCOVA||Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use|||-0.55|-1.09|<0.0001
91617516|NCT00256867|183127823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.32|||<|0.0001||95.0|16.52|79.85|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c \< 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups|||79.85|16.52|<.0001
91617517|NCT00256867|183127824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.32|7.07|||ANCOVA||Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c \< 7% or reduction of HbA1c \>= 0.7% at Week 16 on All FDC group compared to Simv group.|||7.07|2.32|<0.0001
91617518|NCT00256867|183127825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.21|7.0|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG \< 7.0 mmol/L or reduction of FPG \>= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.|||7|2.21|<0.0001
91617519|NCT00875017|183127854|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-65.75|||<|0.001||95.0|-96.01|-35.49|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-35.49|-96.01|<0.001
91617520|NCT00875017|183127854|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-125.65|||<|0.001||95.0|-155.91|-95.39|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-95.39|-155.91|<0.001
91617521|NCT00875017|183127854|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-59.9|||<|0.001||95.0|-89.87|-29.93|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-29.93|-89.87|<0.001
91617522|NCT00875017|183127855|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|71.9|||<|0.001||95.0|40.03|103.77|||Mixed Models Analysis|||Phosphorus binding was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||103.77|40.03|<0.001
91617523|NCT00875017|183127856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.67||||0.049||95.0|-41.22|-0.13|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-0.13|-41.22|0.049
91617524|NCT00875017|183127856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.56||||0.133||95.0|-36.11|4.99|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||4.99|-36.11|0.133
91617525|NCT00875017|183127856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.11||||0.612||95.0|-15.24|25.47|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||25.47|-15.24|0.612
91617526|NCT02932475|183127870|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.63|1.19|||||The odds ratio was calculated and adjusted for study site, timing of diabetes diagnosis, gestational age at randomization stratified at 18 weeks, and baseline maternal BMI.|The sample size gave adequate power over a range of expected primary outcome event rates, with type I error set at 0.044 (reduced from 0.05 for interim analysis), with reasonable power under a conservative scenario assuming that 20% of subjects immediately stopped taking study agent.||1.19|0.63|
91657498|NCT01029353|183208413|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.44|
91657499|NCT01029353|183208413|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.49, 1.33).|||
91657500|NCT01029353|183208414|SUPERIORITY||Mean Difference (Final Values)|-6.01|||||TWO_SIDED|95.0|-12.77|0.75|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.75|-12.77|
91657501|NCT01029353|183208414|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -2.68, 95% credible interval of (-7.11, 1.83).|||
91657502|NCT01029353|183208415|SUPERIORITY||Mean Difference (Final Values)|-8.75|||||TWO_SIDED|95.0|-17.05|-0.46|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||-0.46|-17.05|
91657503|NCT01029353|183208415|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -3.23, 95% credible interval of (-8.08, 1.68).|||
91657504|NCT01029353|183208416|SUPERIORITY||Mean Difference (Final Values)|6.59|||||TWO_SIDED|95.0|-9.09|22.27|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||22.27|-9.09|
91657505|NCT01029353|183208416|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was 1.65, 95% credible interval of (-3.97, 7.23).|||
91657506|NCT01029353|183208417|SUPERIORITY||Mean Difference (Final Values)|-2.56|||||TWO_SIDED|95.0|-13.02|7.91|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||7.91|-13.02|
91657507|NCT01029353|183208417|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -0.71, 95% credible interval of (-5.89, 4.48).|||
91657508|NCT01029353|183208418|SUPERIORITY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-30.54|2.63|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.63|-30.54|
91657509|NCT01029353|183208418|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -1.78, 95% credible interval of (-7.44, 3.87).|||
91657510|NCT01029353|183208419|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.64|
91657511|NCT01029353|183208419|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.95|1.31|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.31|0.95|
91657512|NCT01029353|183208419|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.81, 95% credible interval of (0.63, 1.00). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.09, 95% credible interval of (0.90, 1.33).|||
91657513|NCT01029353|183208420|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.52|1.13|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.13|0.52|
91657514|NCT01029353|183208420|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.79|2.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.06|0.79|
91657515|NCT01029353|183208420|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.53, 1.20). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.18, 95% credible interval of (0.74, 1.87).|||
91657516|NCT01029353|183208421|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.42|1.27|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.27|0.42|
91657517|NCT01029353|183208421|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.85|1.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.45|0.85|
91712785|NCT01516736|183317252|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
91617527|NCT02932475|183127871|SUPERIORITY||Difference in proportions|0.2||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.4
91617528|NCT02932475|183127872|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||comparison of mean (sd) between groups|||||0.4
91617529|NCT02932475|183127873|SUPERIORITY||Difference in proportions|0.0||||0.6|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.6
91617530|NCT02932475|183127874|SUPERIORITY||Difference in proportions|0.0||||0.08|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.08
91617531|NCT00364845|183127877|SUPERIORITY_OR_OTHER||Proportion achieving target|0.389||||||95.0|0.173|0.643||||||||0.643|0.173|
91617532|NCT00364845|183127877|SUPERIORITY_OR_OTHER||Proportion achieving target|0.95||||||95.0|0.751|0.999||||||||0.999|0.751|
91617533|NCT01204658|183127898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
91617534|NCT01204658|183127898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
91617535|NCT01204658|183127898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.62|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.62|0.003
91617536|NCT01204658|183127898|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
91617537|NCT01204658|183127899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
91617538|NCT01204658|183127899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
91617539|NCT01204658|183127899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.63|2.66||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.||2.66|-2.63|0.003
91617540|NCT01204658|183127899|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
91617541|NCT04594239|183127928|SUPERIORITY||Difference in response rates|78.7|||||TWO_SIDED|95.0|66.3|85.6||||||||85.6|66.3|
91617542|NCT04594239|183127928|SUPERIORITY||Difference in response rates|85.4|||||TWO_SIDED|95.0|70.5|92.3||||||||92.3|70.5|
91617543|NCT04594239|183127928|SUPERIORITY||Difference in response rates|71.8|||||TWO_SIDED|95.0|55.2|82.5||||||||82.5|55.2|
91617544|NCT02891798|183127952|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Total Score Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.003
91617545|NCT02891798|183127953|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Continuous Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.001
91617546|NCT02891798|183127954|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Intermittent Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.038
91617547|NCT02891798|183127955|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at post-operative day 1 between the 4-drug nerve block group and the bupivacaine only group||||0.009
91617548|NCT02891798|183127956|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the QoR-15 Total Score.||||||0.861|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.861
91617549|NCT02891798|183127957|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the Standing Balance test.||||||0.512|||||||t-test, 2 sided|||Comparison of Standing Balance Test score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.512
91617550|NCT02891798|183127958|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower rate for the Self-Selected Gait Speed test.||||||0.339|||||||t-test, 2 sided|||Comparison of Self-Selected Gait Speed rate at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.339
91617551|NCT02891798|183127959|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower time for the Repeated Chair Stand test.||||||0.711|||||||t-test, 2 sided|||Comparison of Repeated Chair Stand time at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.711
91617552|NCT00833248|183128002|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.3||||0.8942|TWO_SIDED|95.0|-4.74|4.14|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||FAS. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.14|-4.74|0.8942
91617553|NCT00833248|183128003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.268||||0.9123|TWO_SIDED|95.0|-5.05|4.52|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||PP analysis set. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.52|-5.05|0.9123
91617554|NCT04131517|183128022|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the least squares (LS) means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0404|||||TWO_SIDED|90.0|0.94156|1.1497||||||The analysis of variance model (ANOVA) included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1497|0.94156|
91617555|NCT04131517|183128023|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.89272|||||TWO_SIDED|90.0|0.76892|1.0364||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0364|0.76892|
91657518|NCT01029353|183208421|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Pre-operative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.76, 95% credible interval of (0.48, 1.18). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.08, 95% credible interval of (0.83, 1.42).|||
91617556|NCT04131517|183128026|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0276|||||TWO_SIDED|90.0|0.95544|1.1052||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1052|0.95544|
91617557|NCT04131517|183128027|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL+ OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.88808|||||TWO_SIDED|90.0|0.52185|1.5113||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.5113|0.52185|
91617558|NCT04131517|183128034|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96378|||||TWO_SIDED|90.0|0.85043|1.0922||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0922|0.85043|
91617559|NCT04131517|183128036|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96842|||||TWO_SIDED|90.0|0.91888|1.0206||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0206|0.91888|
91617560|NCT00115349|183128046|SUPERIORITY_OR_OTHER|||||||0.89||0.0|||||Mixed Models Analysis|Linear mixed models with treatment, time, and treatment x time interaction were used, allowing for random participant-specific intercepts and slopes.||The intended sample size of 86 patients (N=43 per arm) had 80% power to detect a 5% difference in LVEF between the two arms after 1 year of treatment, assuming a standard deviation of change in LVEF of 7.46%, and 20% loss to follow-up. The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.||||0.89
91617561|NCT01728584|183128076|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|1.09||||0.026|TWO_SIDED|95.0|0.13|2.04|||ANCOVA|Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)|Difference is deep versus standard NMB|Primary hypothesis - deep NMB improves surgeon's overall satisfaction with the surgical conditions compared to standard NMB||2.04|0.13|0.026
91617562|NCT01728584|183128076|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.02|||<|0.001|TWO_SIDED|95.0|-3.99|-2.05|||ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is low versus standard pressure|||-2.05|-3.99|<0.001
91617563|NCT01728584|183128077|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|3.66|||||TWO_SIDED|95.0|2.3|5.02|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||5.02|2.30|
91617564|NCT01728584|183128077|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.44|||||TWO_SIDED|95.0|-1.8|0.91|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||0.91|-1.80|
91617565|NCT01728584|183128077|SUPERIORITY_OR_OTHER||Difference in LS Means|1.96|||||TWO_SIDED|95.0|0.57|3.36|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.36|0.57|
91617566|NCT01728584|183128077|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.1|||||TWO_SIDED|95.0|-5.42|-2.78|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-2.78|-5.42|
91617567|NCT01728584|183128077|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.7|||||TWO_SIDED|95.0|-3.01|-0.38|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-0.38|-3.01|
91617568|NCT01728584|183128077|SUPERIORITY_OR_OTHER||Difference in LS Means|2.41|||||TWO_SIDED|95.0|1.08|3.74|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.74|1.08|
91524406|NCT02799472|182923976|OTHER||Ratio|0.849||||0.142|TWO_SIDED|95.0|0.681|1.059|||Repeated measures analysis|||MDC, Week 12||1.059|0.681|0.142
91524407|NCT02799472|182923976|OTHER||Ratio|1.013||||0.929|TWO_SIDED|95.0|0.745|1.378|||Repeated measures analysis|||MDC, 12-Week FU||1.378|0.745|0.929
91524408|NCT02799472|182923977|OTHER||Ratio|0.887||||0.463|TWO_SIDED|95.0|0.64|1.231|||Repeated measures analysis|||Chitinase 3 Like 1, Week 1||1.231|0.640|0.463
91617569|NCT01728584|183128078|SUPERIORITY_OR_OTHER||Difference in LS Means|0.35||||0.148|TWO_SIDED|95.0|-0.13|0.84|||ANOVA|Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon|Difference is deep versus standard NMB|||0.84|-0.13|0.148
91617570|NCT01728584|183128078|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17||||0.494|TWO_SIDED|95.0|-0.67|0.33||To control for multiple testing, this difference was formally tested only if comparison of surgeon's overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.|ANOVA|ANOVA model included factors depth of NMB, level of pressure, gender and surgeon|Difference is low versus standard pressure|Key secondary hypothesis - low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure||0.33|-0.67|0.494
91617571|NCT01728584|183128079|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2|||||TWO_SIDED|95.0|-0.92|0.52|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.52|-0.92|
91617572|NCT01728584|183128079|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.65|||||TWO_SIDED|95.0|-1.27|-0.02|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||-0.02|-1.27|
91617573|NCT01728584|183128079|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.15|||||TWO_SIDED|95.0|-0.84|0.53|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.53|-0.84|
91617574|NCT01728584|183128079|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.45|||||TWO_SIDED|95.0|-1.15|0.26|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||0.26|-1.15|
91617575|NCT01728584|183128079|SUPERIORITY_OR_OTHER||Difference in LS Means|0.05|||||TWO_SIDED|95.0|-0.69|0.78|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.78|-0.69|
91617576|NCT01728584|183128079|SUPERIORITY_OR_OTHER||Difference in LS Means|0.49|||||TWO_SIDED|95.0|-0.17|1.16|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||1.16|-0.17|
91617577|NCT01728584|183128080|SUPERIORITY_OR_OTHER||Difference in LS Means|0.91||||0.063|TWO_SIDED|95.0|-0.05|1.87||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.87|-0.05|0.063
91617578|NCT01728584|183128081|SUPERIORITY_OR_OTHER||Difference in LS Means|0.82||||0.004|TWO_SIDED|95.0|0.27|1.37||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.37|0.27|0.004
91617579|NCT01728584|183128082|SUPERIORITY_OR_OTHER||Difference in LS Means|1.12||||0.006|TWO_SIDED|95.0|0.32|1.92||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.92|0.32|0.006
91617580|NCT01728584|183128083|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.61||||0.073|TWO_SIDED|95.0|-1.27|0.06||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||0.06|-1.27|0.073
91524409|NCT02799472|182923977|OTHER||Ratio|0.953||||0.782|TWO_SIDED|95.0|0.672|1.352|||Repeated measures analysis|||Chitinase 3 Like 1, Week 2||1.352|0.672|0.782
91524410|NCT02799472|182923977|OTHER||Ratio|1.132||||0.533|TWO_SIDED|95.0|0.759|1.69|||Repeated measures analysis|||Chitinase 3 Like 1, Week 4||1.690|0.759|0.533
91524411|NCT02799472|182923977|OTHER||Ratio|1.149||||0.473|TWO_SIDED|95.0|0.779|1.694|||Repeated measures analysis|||Chitinase 3 Like 1, Week 6||1.694|0.779|0.473
91524412|NCT02799472|182923977|OTHER||Ratio|1.112||||0.608|TWO_SIDED|95.0|0.733|1.687|||Repeated measures analysis|||Chitinase 3 Like 1, Week 8||1.687|0.733|0.608
91617581|NCT01728584|183128084|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74||||0.009|TWO_SIDED|95.0|0.19|1.28||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.28|0.19|0.009
91617582|NCT02190747|183128147|OTHER|||||||0.1664|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1664
91617583|NCT02190747|183128148|OTHER|||||||0.2335|||||||Cochran-Armitage test of trend|||Week 6: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.2335
91617584|NCT02190747|183128148|OTHER|||||||0.0837|||||||Cochran-Armitage test of trend|||Week 12: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.0837
91617585|NCT02190747|183128149|OTHER||Least square (LS) mean|-86.35|STANDARD_ERROR_OF_MEAN|220.57||0.6984|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.6984
91617586|NCT02190747|183128149|OTHER||LS mean|-38.07|STANDARD_ERROR_OF_MEAN|252.192||0.8811|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.8811
91617587|NCT02190747|183128149|OTHER||LS mean|-764.38|STANDARD_ERROR_OF_MEAN|220.57||0.0017|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0017
91617588|NCT02190747|183128149|OTHER||LS mean|-703.43|STANDARD_ERROR_OF_MEAN|252.192||0.0094|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0094
91617589|NCT02190747|183128150|OTHER|||||||0.1503|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1503
91617590|NCT04322994|183128174|OTHER|||||||0.18||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with any desaturation event.||||0.18
91617591|NCT04322994|183128174|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.||||0.26
91617592|NCT04322994|183128175|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.26
91617593|NCT04322994|183128175|OTHER|||||||0.08||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.||||0.08
91617594|NCT04322994|183128176|OTHER|||||||0.28|||||||Chi-squared|||Analysis of between-group difference for participants with any qualifying event.||||0.28
91617595|NCT04322994|183128176|OTHER|||||||0.38||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.||||0.38
91617596|NCT04322994|183128177|OTHER|||||||0.88||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.88
91617597|NCT04322994|183128178|OTHER|||||||0.14||||||The a priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-squared test of independence||Analysis of between-group difference for participants with any surgical interruption.||||0.14
91617598|NCT04322994|183128178|OTHER|||||||0.21||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.||||0.21
91617599|NCT02345252|183128187|NON_INFERIORITY|A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-0.3|||||TWO_SIDED|95.001|-4.2|3.7|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the FTC/RPV/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the FTC/RPV/TDF group.||3.7|-4.2|
91657519|NCT01029353|183208422|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.47|1.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.05|0.47|
91791460|NCT00713310|183460622|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|1.4||||0.8193|TWO_SIDED|95.0|-20.2|23.0|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||23.0|-20.2|0.8193
91791461|NCT05028361|183460623|NON_INFERIORITY|One-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-5.6||||0.0007|TWO_SIDED|95.0|-15.2|4.0||The upper limit of the 95% CI of the difference was 4% with a noninferiority margin of 10%.|Cochran-Mantel-Haenszel|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting was used.||The null hypothesis is the Simultaneous group is inferior (i.e., Simultaneous group will have a higher proportion) to the Sequential group in regards to the proportion of participants with at least one moderate or severe fever, chills, myalgia, or arthralgia event after visits 1 and 2 using 10% non-inferiority margin.||4.0|-15.2|0.0007
91617600|NCT02345252|183128187|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91617601|NCT02336594|183128200|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio (%)|107.0|||||TWO_SIDED|90.0|95.2|120.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||120|95.2|
91617602|NCT02336594|183128202|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|97.3|||||TWO_SIDED|90.0|85.6|111.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||111|85.6|
91617603|NCT02336594|183128203|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.3|115.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||115|87.3|
91617604|NCT02336594|183128205|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|182.0|||||TWO_SIDED|90.0|144.0|230.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||230|144|
91617605|NCT02336594|183128206|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|140.0|||||TWO_SIDED|90.0|121.0|163.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||163|121|
91791462|NCT05028361|183460624|SUPERIORITY|||||||0.3851|||||||Mantel Haenszel|||||||0.3851
91791463|NCT05028361|183460625|SUPERIORITY|||||||0.2886|||||||Mantel Haenszel|||||||0.2886
91791464|NCT05028361|183460627|OTHER||Comparison of Frequencies|-0.01|||||TWO_SIDED|95.0|-1.66|1.64||The comparison in number of participants with reported SAEs regardless of relationship to study product were made using a difference in proportions along with a 95% confidence interval of the difference.||||||1.64|-1.66|
91617606|NCT02336594|183128207|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|134.0|||||TWO_SIDED|90.0|114.0|156.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||156|114|
91617607|NCT02336594|183128208|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|79.1|||||TWO_SIDED|90.0|66.4|94.2|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.2|66.4|
91617608|NCT02336594|183128209|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|85.5|||||TWO_SIDED|90.0|73.9|98.8|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||98.8|73.9|
91617609|NCT02336594|183128210|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|83.4|||||TWO_SIDED|90.0|73.5|94.7|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.7|73.5|
91617610|NCT02403830|183128219|SUPERIORITY||Mean Difference (Final Values)|-32.0||||0.261|TWO_SIDED|95.0|-90.0|25.0|||Mixed Models Analysis|||||25|-90|0.261
91617611|NCT01954251|183128241|NON_INFERIORITY_OR_EQUIVALENCE|Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.|Adjusted Geometric mean concentration ra|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.||1.20|0.97|
91617612|NCT01954251|183128242|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.04|||||TWO_SIDED|95.0|0.88|1.22||||||For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.22|0.88|
91617613|NCT01954251|183128242|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.03|||||TWO_SIDED|95.0|0.91|1.17||||||For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.17|0.91|
91617614|NCT01954251|183128242|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2||||||For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.20|0.95|
91617615|NCT01954251|183128242|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09||||||For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.09|0.88|
91617616|NCT02232087|183128259|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
91617617|NCT02232087|183128260|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
91617618|NCT02232087|183128261|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.55|TWO_SIDED|95.0|-2.5|1.4||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.4|-2.5|0.55
91617619|NCT02232087|183128261|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.53|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.53
91617620|NCT02232087|183128261|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.011|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.011
91617621|NCT02232087|183128262|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.26|TWO_SIDED|95.0|-0.03|0.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.10|-0.03|0.26
91617622|NCT02232087|183128262|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.06|0.06||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.06|-0.06|0.93
91617623|NCT02232087|183128262|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.04|0.08||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.08|-0.04|0.48
91617624|NCT02232087|183128263|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0||||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||||0.93
91617625|NCT02232087|183128263|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.42|TWO_SIDED|95.0|-0.224|0.093||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.093|-0.224|0.42
91617626|NCT02232087|183128263|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.078|TWO_SIDED|95.0|-0.302|0.016||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.016|-0.302|0.078
91617627|NCT02232087|183128264|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-3.9|5.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||5.7|-3.9|0.71
91617628|NCT02232087|183128264|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-4.7|4.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||4.7|-4.7|1.00
91791465|NCT01993836|183460628|OTHER||Spearman Correlation|-0.03|||||TWO_SIDED|95.0|-0.23|0.18||||||Correlation between 6-week change in Tau and continuous cognitive index||0.18|-0.23|
91791466|NCT01993836|183460628|OTHER||Spearman Correlation|-0.08|||||TWO_SIDED|95.0|-0.29|0.13||||||Correlation between 6-week change in Abeta and continuous cognitive index||0.13|-0.29|
91791467|NCT01993836|183460628|OTHER||Spearman Correlation|0.12|||||TWO_SIDED|95.0|-0.08|0.32||||||Correlation between 6-week change in P-Tau and continuous cognitive index||0.32|-0.08|
91791468|NCT01993836|183460629|OTHER||Spearman Correlation|0.02|||||TWO_SIDED|95.0|-0.19|0.22||||||Correlation between 6-week change in Tau/Abeta ratio and continuous cognitive index||0.22|-0.19|
91791469|NCT01993836|183460629|OTHER||Spearman Correlation|0.16|||||TWO_SIDED|95.0|-0.05|0.34||||||Correlation between 6-week change in P-Tau/Abeta ratio and continuous cognitive index||0.34|-0.05|
91791470|NCT01993836|183460630|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
91791471|NCT01993836|183460631|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau Change between anesthetic groups||||0.532
91524413|NCT02799472|182923977|OTHER||Ratio|1.005||||0.985|TWO_SIDED|95.0|0.613|1.645|||Repeated measures analysis|||Chitinase 3 Like 1, Week 12||1.645|0.613|0.985
91712786|NCT00524771|183317260|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.5|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.||1.5|0.5|
91712787|NCT00524771|183317260|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.||1.7|0.4|
91712788|NCT00524771|183317260|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.2|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of less than 6 months.||2.2|0.3|
91712789|NCT00524771|183317260|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.6|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.||2.6|0.3|
91617629|NCT02232087|183128264|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|-2.0||||0.016|TWO_SIDED|95.0|-10.6|-1.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||-1.1|-10.6|0.016
91712790|NCT00524771|183317260|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.3|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of \> 12 months.||2.3|0.3|
91712791|NCT00524771|183317261|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.3|||||The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.|||2.3|0.2|
91712792|NCT00524771|183317261|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|2.6|||||Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.|||2.6|0.2|
91524414|NCT02799472|182923977|OTHER||Ratio|1.386||||0.102|TWO_SIDED|95.0|0.934|2.057|||Repeated measures analysis|||Chitinase 3 Like 1, 12-Week FU||2.057|0.934|0.102
91617630|NCT01106625|183128270|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.904|-0.524|||ANCOVA|||||-0.524|-0.904|<0.001
91617631|NCT01106625|183128270|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-1.114|-0.732|||ANCOVA|||||-0.732|-1.114|<0.001
91617632|NCT01106625|183128271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42|||<|0.001|TWO_SIDED|95.0|2.48|7.87|||Regression, Logistic|||||7.87|2.48|<0.001
91617633|NCT01106625|183128271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|95.0|4.86|15.95|||Regression, Logistic|||||15.95|4.86|<0.001
91712793|NCT02781818|183317262|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
91712794|NCT02781818|183317262|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
91712795|NCT02781818|183317263|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
91712796|NCT02781818|183317263|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
91712797|NCT02781818|183317264|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
91712798|NCT02781818|183317264|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
91712799|NCT01877668|183317265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.13|STANDARD_ERROR_OF_MEAN|6.67||0.0102|TWO_SIDED|95.0|4.06|30.21|||Large sample approximation|Missing response (MR)=non-response (NR)||||30.21|4.06|0.0102
91712800|NCT01877668|183317265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.24|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.22|40.26|||Large sample approximation|MR=NR||||40.26|14.22|<0.0001
91712801|NCT01877668|183317265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.55|STANDARD_ERROR_OF_MEAN|6.69||0.0055|TWO_SIDED|95.0|5.45|31.66|||Large sample approximation|MR=NR||||31.66|5.45|0.0055
91712802|NCT01877668|183317266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1697|STANDARD_ERROR_OF_MEAN|0.06173||0.0062|TWO_SIDED|95.0|-0.291|-0.0483|||Mixed Models Analysis|No imputation.||||-0.0483|-0.2910|0.0062
91712803|NCT01877668|183317266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2196|STANDARD_ERROR_OF_MEAN|0.06184||0.0004|TWO_SIDED|95.0|-0.3411|-0.098|||Mixed Models Analysis|No imputation.||||-0.0980|-0.3411|0.0004
91617634|NCT01106625|183128272|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.627|<|0.001|TWO_SIDED|95.0|-31.53|-13.16|||ANCOVA|||||-13.16|-31.53|<0.001
91617635|NCT01106625|183128272|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|4.692|<|0.001|TWO_SIDED|95.0|-43.86|-25.42|||ANCOVA|||||-25.42|-43.86|<0.001
91617636|NCT01106625|183128273|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||ANCOVA|||||-0.7|-2.1|<0.001
91617637|NCT01106625|183128273|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.3|||ANCOVA|||||-1.3|-2.7|<0.001
91617638|NCT01106625|183128274|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.262||0.077|TWO_SIDED|95.0|-4.719|0.241|||ANCOVA|||||0.241|-4.719|0.077
91617639|NCT01106625|183128274|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|1.266||0.201|TWO_SIDED|95.0|-4.111|0.866|||ANCOVA|||||0.866|-4.111|0.201
91617640|NCT01106625|183128275|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.4||0.256|TWO_SIDED|95.0|-16.9|4.5|||ANCOVA|||||4.5|-16.9|0.256
91617641|NCT01106625|183128275|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.5||0.571|TWO_SIDED|95.0|-13.8|7.6|||ANCOVA|||||7.6|-13.8|0.571
91617642|NCT01106625|183128276|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.7||0.153|TWO_SIDED|95.0|-0.9|5.9|||ANCOVA|||||5.9|-0.9|0.153
91617643|NCT01106625|183128276|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|1.8||0.056|TWO_SIDED|95.0|-0.1|6.8|||ANCOVA|||||6.8|-0.1|0.056
91617644|NCT02702193|183128286|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|||||Generalized Estimating Equations (GEE)|GEE allowed the examination of trajectories from baseline through the 12 month follow-up.||To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén \& Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.||||<.05
91617645|NCT02512068|183128324|SUPERIORITY||Least square (LS) mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-0.966|-0.473|||ANCOVA|||||-0.473|-0.966|<0.0001
91617646|NCT02512068|183128327|OTHER||Point estimate|-0.28|||||TWO_SIDED|95.0|-0.385|-0.18||||||Change from baseline in HbA1c at Week 2 was compared between the treatment groups.||-0.180|-0.385|
91617647|NCT02512068|183128327|OTHER||Point estimate|-0.48|||||TWO_SIDED|95.0|-0.621|-0.338||||||Change from baseline in HbA1c at Week 4 was compared between the treatment groups.||-0.338|-0.621|
91617648|NCT02512068|183128327|OTHER||Point estimate|-0.58|||||TWO_SIDED|95.0|-0.797|-0.367||||||Change from baseline in HbA1c at Week 8 was compared between the treatment groups.||-0.367|-0.797|
91617649|NCT02512068|183128327|OTHER||Point estimate|-0.71|||||TWO_SIDED|95.0|-0.975|-0.441||||||Change from baseline in HbA1c at Week 12 was compared between the treatment groups.||-0.441|-0.975|
91617650|NCT02512068|183128327|OTHER||Point estimate|-0.7|||||TWO_SIDED|95.0|-0.948|-0.452||||||Change from baseline in HbA1c at End of Treatment Period I was compared between the treatment groups.||-0.452|-0.948|
91617651|NCT02512068|183128328|OTHER||Point estimate|1.7|||||TWO_SIDED|95.0|-6.598|9.919||||||The data of participants achieving \<6.0% at the end of Treatment Period I were compared between the treatment groups.||9.919|-6.598|
91617652|NCT02512068|183128328|OTHER||Point estimate|32.9|||||TWO_SIDED|95.0|14.194|51.66||||||The data of participants achieving \<7.0% at the end of Treatment Period I were compared between the treatment groups.||51.660|14.194|
91617653|NCT02512068|183128328|OTHER||Point estimate|45.6|||||TWO_SIDED|95.0|15.528|75.7||||||The data of participants achieving \<8.0% at the end of Treatment Period I were compared between the treatment groups.||75.700|15.528|
91617654|NCT02512068|183128329|OTHER||Point estimate|-15.2|||||TWO_SIDED|95.0|-23.59|-6.88||||||Change from baseline in fasting plasma glucose at Week 2 was compared between the treatment groups.||-6.88|-23.59|
91617655|NCT02512068|183128329|OTHER||Point estimate|-8.7|||||TWO_SIDED|95.0|-20.98|3.58||||||Change from baseline in fasting plasma glucose at Week 4 was compared between the treatment groups.||3.58|-20.98|
91617656|NCT02512068|183128329|OTHER||Point estimate|-8.3|||||TWO_SIDED|95.0|-18.76|2.11||||||Change from baseline in fasting plasma glucose at Week 8 was compared between the treatment groups.||2.11|-18.76|
91617657|NCT02512068|183128329|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-27.14|-4.03||||||Change from baseline in fasting plasma glucose at Week 12 was compared between the treatment groups.||-4.03|-27.14|
91617658|NCT02512068|183128329|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-26.67|-4.62||||||Change from baseline in fasting plasma glucose at End of Treatment Period I was compared between the treatment groups.||-4.62|-26.67|
91617659|NCT02512068|183128330|OTHER||Point estimate|-1.76|||||TWO_SIDED|95.0|-2.184|-1.34||||||Change from baseline in glycoalbumin at Week 2 was compared between the treatment groups.||-1.340|-2.184|
91617660|NCT02512068|183128330|OTHER||Point estimate|-2.45||||||95.0|-3.03|-1.87||||||Change from baseline in glycoalbumin at Week 4 was compared between the treatment groups.||-1.870|-3.030|
91617661|NCT02512068|183128330|OTHER||Point estimate|-2.48|||||TWO_SIDED|95.0|-3.289|-1.679||||||Change from baseline in glycoalbumin at Week 8 was compared between the treatment groups.||-1.679|-3.289|
91617662|NCT02512068|183128330|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at Week 12 was compared between the treatment groups.||-1.715|-3.608|
91617663|NCT02512068|183128330|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at End of Treatment Period I was compared between the treatment groups.||-1.715|-3.608|
91617664|NCT02458690|183128348|SUPERIORITY|||||||0.6|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.60
91617665|NCT02458690|183128349|SUPERIORITY||||||<|0.01|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||<0.01
91617666|NCT02458690|183128350|SUPERIORITY|||||||0.81|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.81
91617667|NCT02458690|183128351|SUPERIORITY|||||||0.2|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.20
91617668|NCT02458690|183128352|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
91617669|NCT02458690|183128353|SUPERIORITY|||||||0.23|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.23
91617670|NCT02458690|183128354|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
91617671|NCT02439281|183128355|OTHER|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
91617672|NCT02439281|183128356|OTHER|||||||0.8914|||||||Wilcoxon (Mann-Whitney)|||||||0.8914
91617673|NCT02439281|183128359|OTHER|||||||0.9531|||||||Wilcoxon (Mann-Whitney)|||||||0.9531
91657520|NCT01029353|183208422|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.76|1.19|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.19|0.76|
91657521|NCT01029353|183208422|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.73, 95% credible interval of (0.52, 0.96). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.68, 1.32).|||
91657522|NCT01029353|183208423|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.61|1.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.06|0.61|
91657523|NCT01029353|183208423|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.01|1.37|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.37|1.01|
91657524|NCT01029353|183208423|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.80, 95% credible interval of (0.61, 1.01). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.15, 95% credible interval of (0.94, 1.42).|||
91657525|NCT01029353|183208424|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.46|1.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.01|0.46|
91657526|NCT01029353|183208424|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.74|2.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.01|0.74|
91524415|NCT02799472|182923977|OTHER||Ratio|0.915||||0.259|TWO_SIDED|95.0|0.781|1.071|||Repeated measures analysis|||MMP-3, Week 1||1.071|0.781|0.259
91712804|NCT01877668|183317266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2005|STANDARD_ERROR_OF_MEAN|0.06145||0.0012|TWO_SIDED|95.0|-0.3213|-0.0797|||Mixed Models Analysis|No imputation.||||-0.0797|-0.3213|0.0012
91524416|NCT02799472|182923977|OTHER||Ratio|0.959||||0.621|TWO_SIDED|95.0|0.809|1.137|||Repeated measures analysis|||MMP-3, Week 2||1.137|0.809|0.621
91524417|NCT02799472|182923977|OTHER||Ratio|0.914||||0.354|TWO_SIDED|95.0|0.752|1.11|||Repeated measures analysis|||MMP-3, Week 4||1.110|0.752|0.354
91524418|NCT02799472|182923977|OTHER||Ratio|0.8||||0.448|TWO_SIDED|95.0|0.443|1.444|||Repeated measures analysis|||MMP-3, Week 6||1.444|0.443|0.448
91617674|NCT02439281|183128360|OTHER|||||||0.778|||||||Wilcoxon (Mann-Whitney)|||||||0.7780
91617675|NCT02439281|183128361|OTHER|||||||0.5692|||||||Wilcoxon (Mann-Whitney)|||||||0.5692
91617676|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% confidential interval (CI) on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|13.16|||||TWO_SIDED|95.0|8.99|19.28|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|Geometric mean ratio (GMR) of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||19.28|8.99|
91617677|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.88|||||TWO_SIDED|95.0|4.32|8.01|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||8.01|4.32|
91712805|NCT00707057|183317316|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and \>7).||||<0.0001
91712806|NCT00707057|183317317|SUPERIORITY_OR_OTHER||||||<|0.0017||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.||||<0.0017
91712807|NCT00707057|183317318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
91712808|NCT00707057|183317319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
91617678|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.98|||||TWO_SIDED|95.0|12.07|26.78|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||26.78|12.07|
91617679|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.42|||||TWO_SIDED|95.0|1.9|3.08|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||3.08|1.90|
91617680|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.35|||||TWO_SIDED|95.0|4.68|8.61|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||8.61|4.68|
91712809|NCT00707057|183317320|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91712810|NCT00707057|183317321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91712811|NCT00707057|183317321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|||||||<0.0001
91712812|NCT00707057|183317322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and \>7.||The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval. Time weighted TOTPAR for ech specified interval was similarly derived.||||<0.0001
91712813|NCT00707057|183317323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
91617681|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.64|||||TWO_SIDED|95.0|4.92|8.97|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||8.97|4.92|
91617682|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.42|||||TWO_SIDED|95.0|6.91|12.83|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||12.83|6.91|
91617683|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.89|||||TWO_SIDED|95.0|2.96|5.1|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||5.10|2.96|
91657527|NCT01029353|183208424|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.72, 95% credible interval of (0.48, 1.05). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.12, 95% credible interval of (0.71, 1.76).|||
91657528|NCT01029353|183208425|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.51|
91657529|NCT01029353|183208425|SUPERIORITY||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.82|1.93|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.93|0.82|
91657530|NCT01029353|183208425|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.77, 95% credible interval of (0.51, 1.14). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.17, 95% credible interval of (0.76, 1.81).|||
91712814|NCT00707057|183317324|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.||||<0.0001
91712815|NCT00707057|183317325|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.||||<0.0001
91617684|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|62.13|||||TWO_SIDED|95.0|40.16|96.12|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||96.12|40.16|
91712816|NCT00707057|183317326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).||||<0.0001
91791472|NCT01993836|183460631|OTHER|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Abeta Change between anesthetic groups||||0.565
91617685|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|16.37|||||TWO_SIDED|95.0|11.22|23.89|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||23.89|11.22|
91791473|NCT01993836|183460631|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau Change between anesthetic groups||||0.110
91791474|NCT01993836|183460632|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau/Abeta ratio Change between anesthetic groups||||0.439
91791475|NCT01993836|183460632|OTHER|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau/Abeta Change between anesthetic groups||||0.082
91791476|NCT01993836|183460633|OTHER|||||||0.801|||||||Wilcoxon Signed Rank|||||||0.801
91791477|NCT05072470|183460659|SUPERIORITY|When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|||||<|0.01|||||||t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at 0 dB SNR||||<0.01
91524419|NCT02799472|182923977|OTHER||Ratio|1.16||||0.402|TWO_SIDED|95.0|0.813|1.653|||Repeated measures analysis|||MMP-3, Week 8||1.653|0.813|0.402
91617686|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.25|||||TWO_SIDED|95.0|3.22|5.62|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||5.62|3.22|
91617687|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.73|||||TWO_SIDED|95.0|6.24|12.21|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||12.21|6.24|
91617688|NCT05372575|183128363|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.33|||||TWO_SIDED|95.0|6.15|11.29|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||11.29|6.15|
91617689|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMR (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|Geometric Mean Ratio (GMR)|4.78|||||TWO_SIDED|95.0|2.32|9.86|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||9.86|2.32|
91617690|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.06|||||TWO_SIDED|95.0|4.72|17.39|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||17.39|4.72|
91617691|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.37|||||TWO_SIDED|95.0|6.25|33.05|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||33.05|6.25|
91617692|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.03|||||TWO_SIDED|95.0|8.84|36.8|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||36.80|8.84|
91617693|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|33.88|||||TWO_SIDED|95.0|14.33|80.13|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||80.13|14.33|
91657531|NCT01029353|183208426|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.31|0.89|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||0.89|0.31|
91657532|NCT01029353|183208426|SUPERIORITY||Risk Ratio (RR)|0.44|||||TWO_SIDED|95.0|0.29|0.66|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||0.66|0.29|
91712817|NCT00707057|183317327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief."||||<0.0001
91617694|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.05|||||TWO_SIDED|95.0|6.07|32.52|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||32.52|6.07|
91617695|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.99|||||TWO_SIDED|95.0|7.85|36.76|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||36.76|7.85|
91617696|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|19.31|||||TWO_SIDED|95.0|9.13|40.84|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||40.84|9.13|
91657533|NCT01029353|183208427|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|0.58|3.57|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.57|0.58|
91657534|NCT01029353|183208427|SUPERIORITY||Risk Ratio (RR)|1.63|||||TWO_SIDED|95.0|1.06|2.5|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.50|1.06|
91657535|NCT01029353|183208428|SUPERIORITY||Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|0.84|7.55|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||7.55|0.84|
91657536|NCT01029353|183208428|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.38|2.88|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.88|0.38|
91657537|NCT01029353|183208429|SUPERIORITY||Risk Ratio (RR)|1.78|||||TWO_SIDED|95.0|0.82|3.86|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.86|0.82|
91617697|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.46|||||TWO_SIDED|95.0|4.74|23.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||23.10|4.74|
91617698|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.13|||||TWO_SIDED|95.0|6.0|24.51|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||24.51|6.00|
91657538|NCT01029353|183208429|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.42|3.2|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||3.20|0.42|
91657539|NCT01029353|183208430|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|0.35|8.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||8.05|0.35|
91657540|NCT01029353|183208430|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.1|2.44|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.44|0.10|
91657541|NCT01029353|183208431|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.62|2.69|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||2.69|0.62|
91524420|NCT02799472|182923977|OTHER||Ratio|0.951||||0.745|TWO_SIDED|95.0|0.695|1.301|||Repeated measures analysis|||MMP-3, Week 12||1.301|0.695|0.745
91712818|NCT00707057|183317327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.|ANCOVA|||"Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
91617699|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.65|||||TWO_SIDED|95.0|10.94|51.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||51.10|10.94|
91617700|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.62|||||TWO_SIDED|95.0|8.65|35.93|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||35.93|8.65|
91617701|NCT05372575|183128364|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|44.46|||||TWO_SIDED|95.0|19.11|103.43|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||103.43|19.11|
91617702|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|95.0|0.16|1.42|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||1.42|0.16|
91617703|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|1.98|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||1.98|0.27|
91617704|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.21|2.19|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.19|0.21|
91617705|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.36|1.86|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||1.86|0.36|
91657542|NCT01029353|183208431|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.27|1.32|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.32|0.27|
91524421|NCT02799472|182923977|OTHER||Ratio|1.226||||0.279|TWO_SIDED|95.0|0.837|1.796|||Repeated measures analysis|||MMP-3, 12-Week FU||1.796|0.837|0.279
91617706|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.25|1.89|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.89|0.25|
91657543|NCT01029353|183208432|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.41|1.36|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.36|0.41|
91524422|NCT02799472|182923978|OTHER||Ratio|1.098||||0.621|TWO_SIDED|95.0|0.75|1.606|||Repeated measures analysis|||ARGS Neo-Epitope, Week 1||1.606|0.750|0.621
91524423|NCT02799472|182923978|OTHER||Ratio|1.581||||0.031|TWO_SIDED|95.0|1.046|2.388|||Repeated measures analysis|||ARGS Neo-Epitope, Week 2||2.388|1.046|0.031
91617707|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|2.07|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||2.07|0.27|
91617708|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.42|||||TWO_SIDED|95.0|0.16|1.09|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||1.09|0.16|
91617709|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.35|1.81|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.81|0.35|
91617710|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.66|||||TWO_SIDED|95.0|0.2|2.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||2.24|0.20|
91617711|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.6|||||TWO_SIDED|95.0|0.22|1.65|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||1.65|0.22|
91617712|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.55|||||TWO_SIDED|95.0|0.61|3.93|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||3.93|0.61|
91617713|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.8|||||TWO_SIDED|95.0|0.65|4.99|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||4.99|0.65|
91617714|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.47|||||TWO_SIDED|95.0|0.17|1.31|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.31|0.17|
91617715|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.31|1.38|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||1.38|0.31|
91617716|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.7|||||TWO_SIDED|95.0|0.4|1.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||1.24|0.40|
91617717|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.33|1.59|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||1.59|0.33|
91657544|NCT01029353|183208432|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.69|1.42|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.42|0.69|
91617718|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.52|1.25|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||1.25|0.52|
91617719|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||1.52|0.57|
91617720|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.53|||||TWO_SIDED|95.0|0.95|2.47|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||2.47|0.95|
91617721|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.41|1.34|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||1.34|0.41|
91617722|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.34|1.57|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||1.57|0.34|
91617723|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.16|1.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||1.18|0.16|
91617724|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.59|||||TWO_SIDED|95.0|0.25|1.4|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||1.40|0.25|
91617725|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.79|||||TWO_SIDED|95.0|0.5|1.23|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||1.23|0.50|
91657545|NCT01029353|183208433|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.04|4.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||4.45|0.04|
91617726|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.14|||||TWO_SIDED|95.0|0.6|2.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.18|0.60|
91617727|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.08|||||TWO_SIDED|95.0|0.68|1.72|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||1.72|0.68|
91617728|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.3|||||TWO_SIDED|95.0|2.44|43.49|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||43.49|2.44|
91617729|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.17|||||TWO_SIDED|95.0|2.07|18.42|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||18.42|2.07|
91712819|NCT00707057|183317327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
91617730|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.7|||||TWO_SIDED|95.0|4.35|80.37|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||80.37|4.35|
91617731|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.5|||||TWO_SIDED|95.0|1.14|5.52|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||5.52|1.14|
91657546|NCT01029353|183208433|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.44|1.49|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.49|0.44|
91657547|NCT01029353|183208434|SUPERIORITY||Mean Difference (Final Values)|-1.27|||||TWO_SIDED|95.0|-14.1|11.6|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.60|-14.10|
91657548|NCT01029353|183208434|SUPERIORITY||Mean Difference (Final Values)|-7.85|||||TWO_SIDED|95.0|-15.84|0.13|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||0.13|-15.84|
91657549|NCT01029353|183208435|SUPERIORITY||Mean Difference (Final Values)|-11.57|||||TWO_SIDED|95.0|-27.15|4.01|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||4.01|-27.15|
91657550|NCT01029353|183208435|SUPERIORITY||Mean Difference (Final Values)|-7.63|||||TWO_SIDED|95.0|-17.46|2.2|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||2.20|-17.46|
91617732|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.24|||||TWO_SIDED|95.0|2.33|11.8|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||11.80|2.33|
91617733|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.77|||||TWO_SIDED|95.0|1.47|9.65|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||9.65|1.47|
91791478|NCT05072470|183460659|SUPERIORITY|||||||0.031||||||When p value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at -5 dB SNR||||.031
91791479|NCT05072470|183460659|SUPERIORITY|||||||0.046||||||When p-values are adjusted for multiple comparisons, the level of statistical significance must be \</= .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be equal or better with hearing aids plus Roger device than with hearing aids alone when tested using standardized speech test at +5 dB SNR.||||.046
91791480|NCT02514473|183460690|SUPERIORITY||Least Square (LS) Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.75|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM). The model included treatment, visit and treatment-by-visit interaction as fixed effects; and participant as a random effect with adjustments for baseline, weight (less than \[\<\] 25 kilogram \[kg\] versus greater than or equal to \[\>=\] 25 kg) and percent predicted forced expiratory volume in 1 second (FEV1) severity (\<90 versus \>=90) at screening.||-0.75|-1.43|< 0.0001
91791481|NCT02106923|183460711|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.98|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.505|105.514|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.514|100.505|<0.0001
91791482|NCT02106923|183460711|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.25|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.809|103.823|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.823|96.809|<0.0001
91791483|NCT02106923|183460711|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.08|STANDARD_ERROR_OF_MEAN|1.016|<|0.0001|TWO_SIDED|90.0|93.507|98.721|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||98.721|93.507|<0.0001
91791484|NCT02106923|183460712|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.06||0.0011|TWO_SIDED|90.0|92.3|112.81|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||112.81|92.30|0.0011
91617734|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.94|||||TWO_SIDED|95.0|1.65|21.36|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||21.36|1.65|
91617735|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.44|||||TWO_SIDED|95.0|1.17|16.87|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||16.87|1.17|
91791485|NCT02106923|183460712|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.93|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|95.45|102.53|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.53|95.45|<0.0001
91791486|NCT02106923|183460712|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.7|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|93.59|110.52|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||110.52|93.59|0.0002
91791487|NCT02106923|183460713|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.88|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.446|105.373|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.373|100.446|<0.0001
91791488|NCT02106923|183460713|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.03|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.448|103.738|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.738|96.448|<0.0001
91791489|NCT02106923|183460713|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.49|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|93.758|99.311|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||99.311|93.758|<0.0001
91791490|NCT02106923|183460714|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|104.83|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.522|110.412|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||110.412|99.522|<0.0001
91617736|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|90.8|||||TWO_SIDED|95.0|16.67|494.56|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||494.56|16.67|
91617737|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.83|||||TWO_SIDED|95.0|3.79|83.78|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||83.78|3.79|
91617738|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.11|||||TWO_SIDED|95.0|3.6|18.3|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||18.30|3.60|
91617739|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|15.29|||||TWO_SIDED|95.0|4.64|50.35|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||50.35|4.64|
91617740|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.19|||||TWO_SIDED|95.0|1.72|10.25|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||10.25|1.72|
91617741|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|13.93|||||TWO_SIDED|95.0|9.14|21.23|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||21.23|9.14|
91617742|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.86|||||TWO_SIDED|95.0|4.17|8.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||8.24|4.17|
91617743|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|19.97|||||TWO_SIDED|95.0|12.8|31.15|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||31.15|12.80|
91657551|NCT01029353|183208436|SUPERIORITY||Mean Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-18.84|26.83|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||26.83|-18.84|
91657552|NCT01029353|183208436|SUPERIORITY||Mean Difference (Final Values)|9.05|||||TWO_SIDED|95.0|-13.29|31.38|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||31.38|-13.29|
91712820|NCT00707057|183317328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
91617744|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.46|||||TWO_SIDED|95.0|1.87|3.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||3.24|1.87|
91617745|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.12|||||TWO_SIDED|95.0|5.05|10.03|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||10.03|5.05|
91617746|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.78|||||TWO_SIDED|95.0|5.54|10.92|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||10.92|5.54|
91617747|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.4|||||TWO_SIDED|95.0|7.4|14.61|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||14.61|7.40|
91617748|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.07|||||TWO_SIDED|95.0|3.04|5.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||5.47|3.04|
91617749|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|60.32|||||TWO_SIDED|95.0|37.25|97.67|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||97.67|37.25|
91617750|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.35|||||TWO_SIDED|95.0|11.37|26.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||26.47|11.37|
91657553|NCT01029353|183208437|SUPERIORITY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-24.62|18.36|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||18.36|-24.62|
91712821|NCT00707057|183317328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and basee pain score categories.|ANCOVA|||Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
91617751|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.11|||||TWO_SIDED|95.0|3.0|5.62|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||5.62|3.00|
91617752|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.68|||||TWO_SIDED|95.0|6.65|14.08|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||14.08|6.65|
91617753|NCT05372575|183128365|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.7|||||TWO_SIDED|95.0|6.9|13.64|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||13.64|6.90|
91617754|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.49|||||TWO_SIDED|95.0|0.06|3.91|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||3.91|0.06|
91617755|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.54|||||TWO_SIDED|95.0|0.1|2.92|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||2.92|0.10|
91617756|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.45|||||TWO_SIDED|95.0|0.1|2.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.07|0.10|
91617757|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.78|||||TWO_SIDED|95.0|0.27|11.75|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||11.75|0.27|
91617758|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.23|||||TWO_SIDED|95.0|0.03|1.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.65|0.03|
91617759|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.06|||||TWO_SIDED|95.0|0.01|0.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||0.44|0.01|
91712822|NCT00707057|183317328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
91524424|NCT02799472|182923978|OTHER||Ratio|1.222||||0.317|TWO_SIDED|95.0|0.817|1.827|||Repeated measures analysis|||ARGS Neo-Epitope, Week 4||1.827|0.817|0.317
91617760|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.21|||||TWO_SIDED|95.0|0.56|2.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||2.65|0.56|
91617761|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.2|||||TWO_SIDED|95.0|0.03|1.26|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.26|0.03|
91617762|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.36|||||TWO_SIDED|95.0|0.08|1.55|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||1.55|0.08|
91617763|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.15|4.47|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||4.47|0.15|
91617764|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.35|||||TWO_SIDED|95.0|0.19|9.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||9.44|0.19|
91617765|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.87|||||TWO_SIDED|95.0|0.67|22.42|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||22.42|0.67|
91617766|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.27|||||TWO_SIDED|95.0|0.05|1.52|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.52|0.05|
91617767|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.76|||||TWO_SIDED|95.0|0.19|3.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||3.07|0.19|
91617768|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.02|||||TWO_SIDED|95.0|0.42|2.46|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||2.46|0.42|
91617769|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.05|3.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||3.73|0.05|
91617770|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.15|2.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||2.73|0.15|
91617771|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.88|||||TWO_SIDED|95.0|0.11|6.99|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||6.99|0.11|
91657554|NCT01029353|183208437|SUPERIORITY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-14.42|9.63|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||9.63|-14.42|
91712823|NCT00707057|183317329|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
91657555|NCT01029353|183208438|SUPERIORITY||Mean Difference (Final Values)|-18.43|||||TWO_SIDED|95.0|-48.41|11.55|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.55|-48.41|
91617772|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.9|||||TWO_SIDED|95.0|0.29|12.51|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||12.51|0.29|
91617773|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.45|||||TWO_SIDED|95.0|0.34|17.43|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||17.43|0.34|
91617774|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.43|||||TWO_SIDED|95.0|0.27|7.7|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||7.70|0.27|
91617775|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.3|||||TWO_SIDED|95.0|0.3|17.41|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||17.41|0.30|
91617776|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.14|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||2.97|0.14|
91617777|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.51|||||TWO_SIDED|95.0|0.28|8.21|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||8.21|0.28|
91657556|NCT01029353|183208438|SUPERIORITY||Mean Difference (Final Values)|-11.95|||||TWO_SIDED|95.0|-31.96|8.06|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||8.06|-31.96|
91657557|NCT04538170|183208440|SUPERIORITY|||||||0.013||||||threshold for statistical significance|Fisher Exact|||Preliminary work showed that approximately 25% of patients report phantom pain after orchidectomy. A difference of 20% between the GAC and ORC groups was considered relevant. Power was set to 80% and the significance level to 5%, resulting in a minimum of 40 women to be recruited, which was fulfilled.||||0.013
91657558|NCT00637299|183208443|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||||||<0.01
91657559|NCT00637299|183208444|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
91657560|NCT00959660|183208451|SUPERIORITY||||||<|0.001||||||Main effects analysis with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
91657561|NCT00959660|183208451|SUPERIORITY||||||<|0.001||||||Main effects analysis with Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
91657562|NCT00959660|183208452|SUPERIORITY|||||||0.004||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.004
91617778|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.13|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.97|0.13|
91617779|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.23|||||TWO_SIDED|95.0|0.15|10.24|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||10.24|0.15|
91657563|NCT00959660|183208452|SUPERIORITY|||||||0.43||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.43
91657564|NCT00959660|183208453|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||<0.001
91657565|NCT00959660|183208453|SUPERIORITY|||||||0.001||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||0.001
91657566|NCT00959660|183208453|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||<0.001
91657567|NCT00959660|183208453|SUPERIORITY|||||||0.25||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||0.25
91657568|NCT00959660|183208454|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||<0.001
91657569|NCT00959660|183208454|SUPERIORITY|||||||0.26||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||0.26
91657570|NCT00959660|183208454|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||<0.001
91617780|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.15|||||TWO_SIDED|95.0|0.41|23.91|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||23.91|0.41|
91617781|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|5.02|||||TWO_SIDED|95.0|1.45|17.39|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||17.39|1.45|
91617782|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.7|||||TWO_SIDED|95.0|1.32|141.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||141.81|1.32|
91617783|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.41|||||TWO_SIDED|95.0|6.16|380.54|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||380.54|6.16|
91617784|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.47|||||TWO_SIDED|95.0|0.48|229.1|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||229.10|0.48|
91657571|NCT00959660|183208454|SUPERIORITY|||||||0.26||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||0.26
91657572|NCT00849901|183208457|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Mixed Models Analysis|||||||0.999
91657573|NCT00262223|183208469|SUPERIORITY_OR_OTHER_LEGACY||Incidence Rate Ratio|1.6||||0.34|TWO_SIDED|95.0|0.61|4.23|||Generalized Estimating Equations|Negative binomial models with log link were applied to the alcohol consumption measure.||Between group analyses were conducted of time-by-treatment interaction that included the four study time points (baseline, end-of-treatment, 6-mos and 12-mos).||4.23|0.61|0.34
91657574|NCT00262223|183208470|SUPERIORITY_OR_OTHER_LEGACY||Parameter Estimate|-16.15||||0.04|TWO_SIDED|95.0|-31.18|-1.13||A trend-level time-by-treatment interaction (p = .096) was probed for simple effects, which revealed a significantly greater reduction in CAPS scores at end-of-treatment in the SS+Sertraline group relative to the SS+Placebo group.|Generalized Estimating Equations|||Generalized estimating equations (GEE) were utilized to model PTSD outcomes. This method is an extension of the generalized linear model that handles correlated data arising from repeated measurements, requires no parametric distribution assumption, and provides robust inference with respect to misspecification of the within-subject correlation. A temporal within-subjects autoregressive \[AR(1)\] correlation matrix was used to model participants across timepoints.||-1.13|-31.18|0.04
91657575|NCT03828734|183208471|SUPERIORITY|||||||0.263|||||||ANOVA|||||||0.263
91657576|NCT03828734|183208472|SUPERIORITY||||||<|1e-06|||||||ANOVA|||||||<0.000001
91657577|NCT03828734|183208473|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
91617785|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.02|19.83|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||19.83|0.02|
91657578|NCT00437658|183208479|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-0.3||||0.963|TWO_SIDED|95.0|-13.4|12.7|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||12.7|-13.4|0.9630
91657579|NCT00437658|183208479|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-12.4||||0.101|TWO_SIDED|95.0|-26.7|1.8|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||1.8|-26.7|0.1010
91657580|NCT00437658|183208480|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|9.5||||0.2048|TWO_SIDED|95.0|-5.2|24.2|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||24.2|-5.2|0.2048
91657581|NCT00437658|183208480|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|0.5||||0.9544|TWO_SIDED|95.0|-15.1|16.0|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||16.0|-15.1|0.9544
91524425|NCT02799472|182923978|OTHER||Ratio|1.302||||0.113|TWO_SIDED|95.0|0.936|1.81|||Repeated measures analysis|||ARGS Neo-Epitope, Week 6||1.810|0.936|0.113
91524426|NCT02799472|182923978|OTHER||Ratio|1.45||||0.217|TWO_SIDED|95.0|0.795|2.645|||Repeated measures analysis|||ARGS Neo-Epitope, Week 8||2.645|0.795|0.217
91617786|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.53|||||TWO_SIDED|95.0|1.98|55.96|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||55.96|1.98|
91524427|NCT02799472|182923978|OTHER||Ratio|1.266||||0.147|TWO_SIDED|95.0|0.916|1.75|||Repeated measures analysis|||ARGS Neo-Epitope, Week 12||1.750|0.916|0.147
91617787|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.32|||||TWO_SIDED|95.0|0.19|56.82|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||56.82|0.19|
91617788|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.0|||||TWO_SIDED|95.0|0.06|63.12|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||63.12|0.06|
91617789|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.31|||||TWO_SIDED|95.0|2.15|123.48|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||123.48|2.15|
91617790|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|24.16|||||TWO_SIDED|95.0|1.59|367.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||367.81|1.59|
91617791|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|95.06|||||TWO_SIDED|95.0|13.08|691.01|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||691.01|13.08|
91617792|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.49|||||TWO_SIDED|95.0|0.64|171.84|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||171.84|0.64|
91617793|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|4.86|||||TWO_SIDED|95.0|2.15|10.96|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||10.96|2.15|
91617794|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.57|||||TWO_SIDED|95.0|4.5|20.36|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||20.36|4.50|
91617795|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.4|||||TWO_SIDED|95.0|5.2|34.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||34.51|5.20|
91617796|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.15|||||TWO_SIDED|95.0|7.76|37.91|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||37.91|7.76|
91617797|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|40.2|||||TWO_SIDED|95.0|15.16|106.65|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||106.65|15.16|
91617798|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|20.38|||||TWO_SIDED|95.0|8.39|49.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||49.51|8.39|
91617799|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|21.22|||||TWO_SIDED|95.0|8.65|52.07|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||52.07|8.65|
91617800|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.73|||||TWO_SIDED|95.0|10.39|54.19|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||54.19|10.39|
91617801|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.84|||||TWO_SIDED|95.0|5.46|30.22|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||30.22|5.46|
91617802|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.88|||||TWO_SIDED|95.0|5.95|27.88|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||27.88|5.95|
91617803|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|26.99|||||TWO_SIDED|95.0|11.46|63.58|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||63.58|11.46|
91617804|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|15.53|||||TWO_SIDED|95.0|7.02|34.38|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||34.38|7.02|
91617805|NCT05372575|183128366|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.73|||||TWO_SIDED|95.0|18.67|127.16|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||127.16|18.67|
91617806|NCT03345836|183128367|SUPERIORITY||Adjusted Risk Difference|17.9|||<|0.0001|TWO_SIDED|95.0|10.0|25.8||P-value was calculated using Cochran-Mantel Haenszel (CMH) test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% confidence interval (CI) were calculated using CMH risk difference estimate.|||25.8|10.0|<0.0001
91617807|NCT03345836|183128368|SUPERIORITY||Adjusted Risk Difference|31.2|||<|0.0001|TWO_SIDED|95.0|25.5|37.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH risk difference estimate.|||37.0|25.5|<0.0001
91617808|NCT03345836|183128370|SUPERIORITY||Adjusted Treatment Difference|25.9|||<|0.0001|TWO_SIDED|95.0|18.7|33.1||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||33.1|18.7|<0.0001
91617809|NCT03345836|183128371|SUPERIORITY||Adjusted Treatment Difference|16.8|||<|0.0001|TWO_SIDED|95.0|12.0|21.6||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||21.6|12.0|<0.0001
91617810|NCT03345836|183128372|SUPERIORITY||Adjusted Treatment Difference|22.5||||0.0001|TWO_SIDED|95.0|11.1|34.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||34.0|11.1|0.0001
91657582|NCT00437658|183208483|OTHER||Least squares mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-6.2|-4.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.8|-6.2|< 0.0001
91657583|NCT00437658|183208483|OTHER||Least squares mean|-5.2|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.5|-5.8|< 0.0001
91657584|NCT00437658|183208483|OTHER||Least squares mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.0|-4.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.6|-6.0|< 0.0001
91617811|NCT03345836|183128373|SUPERIORITY||Adjusted Treatment Difference|7.5|||<|0.0001|TWO_SIDED|95.0|5.2|9.8||P-value was calculated using mixed effect model repeat measurement (MMRM) with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||9.8|5.2|< 0.0001
91617812|NCT03345836|183128374|SUPERIORITY||Adjusted Treatment Difference|24.3|||<|0.0001|TWO_SIDED|95.0|17.2|31.5||P-value was calculated using MMRM with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||31.5|17.2|< 0.0001
91791491|NCT02106923|183460714|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.84|STANDARD_ERROR_OF_MEAN|1.041|<|0.0001|TWO_SIDED|90.0|95.03|109.134|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||109.134|95.030|<0.0001
91791492|NCT02106923|183460714|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.03|STANDARD_ERROR_OF_MEAN|1.037|<|0.0001|TWO_SIDED|90.0|90.217|102.211|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||102.211|90.217|<0.0001
91791493|NCT02106923|183460715|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.94|STANDARD_DEVIATION|1.071||0.0027|TWO_SIDED|90.0|87.925|111.329|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||111.329|87.925|0.0027
91791494|NCT02106923|183460715|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|108.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|102.792|113.859|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||113.859|102.792|<0.0001
91617813|NCT03345836|183128375|SUPERIORITY||Adjusted Treatment Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.7|27.8||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||27.8|13.7|<0.0001
91617814|NCT03345836|183128376|SUPERIORITY||Adjusted Treatment Difference|22.8|||<|0.0001|TWO_SIDED|95.0|14.4|31.2||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||31.2|14.4|<0.0001
91791495|NCT02106923|183460715|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.62|STANDARD_ERROR_OF_MEAN|1.071||0.006|TWO_SIDED|90.0|92.116|116.559|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||116.559|92.116|0.0060
91791496|NCT02106923|183460716|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.33|STANDARD_ERROR_OF_MEAN|1.06||0.0008|TWO_SIDED|90.0|89.13|108.47|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||108.47|89.13|0.0008
91791497|NCT02106923|183460716|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.71|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|94.77|102.8|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.80|94.77|<0.0001
91791498|NCT02106923|183460716|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.9|STANDARD_ERROR_OF_MEAN|1.06||0.0021|TWO_SIDED|90.0|94.09|114.74|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||114.74|94.09|0.0021
91791499|NCT03485495|183460717|SUPERIORITY|||||||0.007||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.007
91791500|NCT03485495|183460718|SUPERIORITY|||||||0.0272||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|Fisher Exact|||||||0.0272
91791501|NCT03485495|183460719|SUPERIORITY|||||||0.8762|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.8762
91657585|NCT00437658|183208484|OTHER||Least squares mean|-4.6|||<|0.0001|TWO_SIDED|95.0|-5.1|-4.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.0|-5.1|<0.0001
91657586|NCT00437658|183208484|OTHER||Least squares mean|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.0|<0.0001
91657587|NCT00437658|183208484|OTHER||Least squares mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.1|< 0.0001
91657588|NCT00437658|183208485|OTHER||Least squares mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.7|< 0.0001
91657589|NCT00437658|183208485|OTHER||Least squares mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.6|< 0.0001
91657590|NCT00437658|183208485|OTHER||Least squares mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.4|-1.9|< 0.0001
91657591|NCT00437658|183208486|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.9|-1.4|< 0.0001
91657592|NCT00437658|183208486|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|2.0|-1.2|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.2|< 0.0001
91657593|NCT00437658|183208486|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.5|-1.1|< 0.0001
91524428|NCT02799472|182923978|OTHER||Ratio|0.996||||0.985|TWO_SIDED|95.0|0.662|1.499|||Repeated measures analysis|||ARGS Neo-Epitope, 12-Week FU||1.499|0.662|0.985
91657594|NCT00437658|183208487|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
91657595|NCT00437658|183208487|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
91712824|NCT00707057|183317329|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
91712825|NCT00707057|183317329|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
91712826|NCT01781208|183317352|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.68, unadjusted for age, gender, and histologic inflammation.|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
91712827|NCT01781208|183317352|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.73, unadjusted for age, gender, and histologic inflammation score|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
91712828|NCT00823134|183317363|OTHER||Mean Difference (Final Values)|2.8|STANDARD_DEVIATION|4.7||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
91617815|NCT03345836|183128377|SUPERIORITY||Adjusted Treatment Difference|12.1||||0.0013|TWO_SIDED|95.0|4.7|19.5||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||19.5|4.7|0.0013
91617816|NCT03345836|183128378|SUPERIORITY||Treatment Difference|-2.6||||0.2834|TWO_SIDED|95.0|-7.6|2.4||P-value was calculated using Chi-squared test.|Chi-squared||Point estimate and 95% CI was calculated using Chi-squared test.|||2.4|-7.6|0.2834
91617817|NCT03345836|183128379|SUPERIORITY||Adjusted Treatment Difference|11.5||||0.0833|TWO_SIDED|95.0|-1.5|24.4||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||24.4|-1.5|0.0833
91617818|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|1.8|||||TWO_SIDED|90.0|-0.4|4.1||||||1 hour postdose||4.1|-0.4|
91617819|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|2.7|||||TWO_SIDED|90.0|0.4|4.9||||||1.5 hours postdose||4.9|0.4|
91617820|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.1|4.4||||||2 hours postdose||4.4|-0.1|
91617821|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|90.0|-2.8|1.7||||||3 hours postdose||1.7|-2.8|
91617822|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-4.1|||||TWO_SIDED|90.0|-6.3|-1.8||||||4 hours postdose||-1.8|-6.3|
91617823|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-3.5|||||TWO_SIDED|90.0|-5.7|-1.2||||||6 hours postdose||-1.2|-5.7|
91617824|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-4.9|||||TWO_SIDED|90.0|-7.1|-2.6||||||12 hours postdose||-2.6|-7.1|
91617825|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-0.9|||||TWO_SIDED|90.0|-3.1|1.4||||||24 hours postdose||1.4|-3.1|
91712829|NCT00823134|183317364|OTHER|The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).|Correlation coefficient (Bland-Altman)|0.75|||||TWO_SIDED|||||||||Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \>75% will be seen as threshold for validity.||||
91791502|NCT03485495|183460720|SUPERIORITY|||||||0.2082|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.2082
91791503|NCT03485495|183460721|SUPERIORITY|||||||0.0038||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-3 data.||||0.0038
91791504|NCT03485495|183460721|SUPERIORITY|||||||0.0018||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-2 data.||||0.0018
91791505|NCT03485495|183460721|SUPERIORITY|||||||0.46||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO data.||||0.46
91791506|NCT03485495|183460722|SUPERIORITY|||||||0.88||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADP-PA data.||||0.88
91524429|NCT02799472|182923978|OTHER||Ratio|0.892||||0.681|TWO_SIDED|95.0|0.511|1.56|||Repeated measures analysis|||CMDV, Week 1||1.560|0.511|0.681
91617826|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||1 hour postdose||3.1|-1.4|
91617827|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|2.0|||||TWO_SIDED|90.0|-0.2|4.2||||||1.5 hours postdose||4.2|-0.2|
91617828|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||2 hours postdose||3.1|-1.4|
91617829|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-1.6|||||TWO_SIDED|90.0|-3.8|0.7||||||3 hours postdose||0.7|-3.8|
91617830|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-3.7|||||TWO_SIDED|90.0|-5.9|-1.5||||||4 hours postdose||-1.5|-5.9|
91617831|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-2.3|||||TWO_SIDED|90.0|-4.6|-0.1||||||6 hours postdose||-0.1|-4.6|
91617832|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-5.1|||||TWO_SIDED|90.0|-7.3|-2.8||||||12 hours postdose||-2.8|-7.3|
91617833|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|-0.2|||||TWO_SIDED|90.0|-2.4|2.1||||||24 hours postdose||2.1|-2.4|
91617834|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|10.8|||||TWO_SIDED|98.0|7.6|14.0||||||1 hour postdose||14.0|7.6|
91617835|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|10.2|||||TWO_SIDED|98.0|7.0|13.4||||||1.5 hours postdose||13.4|7.0|
91617836|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|11.2|||||TWO_SIDED|98.0|8.0|14.4||||||2 hours postdose||14.4|8.0|
91617837|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|11.5|||||TWO_SIDED|98.0|8.3|14.7||||||3 hours postdose||14.7|8.3|
91617838|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|9.7|||||TWO_SIDED|98.0|6.5|12.8||||||4 hours postdose||12.8|6.5|
91657596|NCT00437658|183208487|OTHER||Least squares mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-0.8|-1.3|< 0.0001
91657597|NCT00437658|183208488|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.2|< 0.0001
91524430|NCT02799472|182923978|OTHER||Ratio|0.87||||0.668|TWO_SIDED|95.0|0.454|1.669|||Repeated measures analysis|||CMDV, Week 2||1.669|0.454|0.668
91617839|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|10.4|||||TWO_SIDED|98.0|7.2|13.5||||||6 hours postdose||13.5|7.2|
91617840|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|7.3|||||TWO_SIDED|98.0|4.1|10.4||||||12 hours postdose||10.4|4.1|
91617841|NCT03510663|183128380|SUPERIORITY||Least Squares Mean Difference|7.0|||||TWO_SIDED|98.0|3.8|10.2||||||24 hours postdose||10.2|3.8|
91617842|NCT01798706|183128398|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.81|-0.464||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline HbA1c value as a covariate.||-0.464|-0.81|< 0.0001
91617843|NCT01798706|183128399|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.05|STANDARD_ERROR_OF_MEAN|0.464|<|0.0001|TWO_SIDED|95.0|-5.96|-4.132||Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.||-4.132|-5.96|< 0.0001
91617844|NCT01798706|183128400|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.219|<|0.0001|TWO_SIDED|95.0|-1.39|-0.527||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.||-0.527|-1.39|< 0.0001
91617845|NCT01798706|183128401|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-1.862|-0.769||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline body weight value as a covariate.||-0.769|-1.862|< 0.0001
91617846|NCT01798706|183128402|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.262||0.2347|TWO_SIDED|95.0|-0.828|0.204||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline FPG value as a covariate.||0.204|-0.828|0.2347
91617847|NCT00962039|183128461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.12|0.1||Analyses were conducted over 8 week follow-up.|Chi-squared|||||0.10|-0.12|0.92
91617848|NCT00962039|183128462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.034|TWO_SIDED|95.0|-0.15|-0.01|||Chi-squared|||||-0.01|-0.15|0.034
91617849|NCT00962039|183128463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.261|TWO_SIDED|95.0|-0.07|0.02|||t-test, 2 sided|||||0.02|-0.07|0.261
91791507|NCT03485495|183460722|SUPERIORITY|||||||0.93||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADR-PA data.||||0.93
91791508|NCT00924170|183460761|SUPERIORITY||||||<|0.0001|||||||Kaplan Meier|||Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.||||<0.0001
91791509|NCT00579436|183460775|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
91657598|NCT00437658|183208488|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.1|< 0.0001
91657599|NCT00437658|183208488|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
91657600|NCT00437658|183208489|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.0|< 0.0001
91657601|NCT00437658|183208489|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
91657602|NCT00437658|183208489|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.6|||t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.6|-0.9|<0.0001
91657603|NCT00437658|183208490|OTHER||Least squares mean|-32.3|||<|0.0001|TWO_SIDED|95.0|-39.2|-25.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-25.4|-39.2|< 0.0001
91657604|NCT00437658|183208490|OTHER||Least squares mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.4|-26.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-26.4|-39.4|< 0.0001
91657605|NCT00437658|183208490|OTHER||Least squares mean|-35.8|||<|0.0001|TWO_SIDED|95.0|-43.0|-28.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-28.6|-43.0|< 0.0001
91657606|NCT00437658|183208491|OTHER||Least squares mean|-18.2|||<|0.0001|TWO_SIDED|95.0|-23.3|-13.1||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-13.1|-23.3|< 0.0001
91657607|NCT00437658|183208491|OTHER||Least squares mean|-23.4|||<|0.0001|TWO_SIDED|95.0|-28.3|-18.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-18.5|-28.3|< 0.0001
91657608|NCT00437658|183208491|OTHER||Least squares mean|-17.9|||<|0.0001|TWO_SIDED|95.0|-23.1|-12.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-12.7|-23.1|< 0.0001
91657609|NCT03952143|183208503|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07||||0.321|TWO_SIDED|95.0|-0.07|0.21|||Mixed Models Analysis|||||0.21|-0.07|0.321
91657610|NCT03952143|183208504|SUPERIORITY||LS Mean Difference|-14.6|||<|0.001|TWO_SIDED|95.0|-21.9|-7.4|||ANCOVA|||||-7.4|-21.9|<0.001
91712830|NCT00078403|183317370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||||||P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.|Exact Wilcoxon rank sum test|||Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.||||0.58
91712831|NCT00619827|183317405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0003|TWO_SIDED|95.0|-2.99|-0.94|||ANCOVA|||||-0.94|-2.99|0.0003
91712832|NCT01111565|183317413|SUPERIORITY||Treatment Difference|-5.4|||=|0.079|TWO_SIDED|95.0|-11.5|0.7|||ANCOVA|||||0.7|-11.5|=0.079
91617850|NCT00962039|183128464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.519|TWO_SIDED|95.0|-0.36|0.18|||t-test, 2 sided|||||0.18|-0.36|0.519
91712833|NCT01111565|183317413|SUPERIORITY||Treatment Difference|-5.2|||=|0.085|TWO_SIDED|95.0|-11.2|0.7|||ANCOVA|||||0.7|-11.2|=0.085
91712834|NCT01111565|183317414|SUPERIORITY||Treatment Difference|-0.5|||=|0.148|TWO_SIDED|95.0|-1.1|0.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.1|-1.1|=0.148
91712835|NCT01111565|183317414|SUPERIORITY||Treatment Difference|-0.4|||=|0.242|TWO_SIDED|95.0|-1.0|0.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.3|-1.0|=0.242
91617851|NCT00962039|183128465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.704|TWO_SIDED|95.0|-0.77|0.52|||t-test, 2 sided|||||0.52|-0.77|0.704
91617852|NCT00962039|183128466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.59||||0.046|TWO_SIDED|95.0|0.01|1.17|||t-test, 2 sided|||||1.17|0.01|0.046
91617853|NCT03453151|183128467|OTHER|||||||0.053|||||||Paired t-test|||||||0.053
91617854|NCT03453151|183128468|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91617855|NCT03453151|183128469|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
91617856|NCT03453151|183128470|OTHER|||||||0.077|||||||Paired t-test|This analysis refers to the resting cardiac index.||||||0.077
91657611|NCT03952143|183208505|SUPERIORITY||LS Mean Difference|-21.8|||<|0.001|TWO_SIDED|95.0|-30.9|-12.6|||ANCOVA|||||-12.6|-30.9|<0.001
91657612|NCT03952143|183208506|SUPERIORITY||Relative rate|0.26|||||TWO_SIDED|95.0|0.02|2.86||||||||2.86|0.02|
91657613|NCT03952143|183208507|SUPERIORITY||Relative rate|0.9|||||TWO_SIDED|95.0|0.49|1.66||||||For ≤30 minutes post meal||1.66|0.49|
91657614|NCT03952143|183208507|SUPERIORITY||Relative rate|1.35|||||TWO_SIDED|95.0|0.79|2.31||||||For ≤ 1 hour post meal||2.31|0.79|
91657615|NCT03952143|183208507|SUPERIORITY||Relative rate|1.6|||||TWO_SIDED|95.0|1.06|2.42||||||For \>1 to ≤2 hours post meal||2.42|1.06|
91657616|NCT03952143|183208507|SUPERIORITY||Relative rate|1.53|||||TWO_SIDED|95.0|1.05|2.23||||||For ≤2 hours post meal||2.23|1.05|
91657617|NCT03952143|183208507|SUPERIORITY||Relative rate|0.97|||||TWO_SIDED|95.0|0.69|1.39||||||For \>2 to ≤4 hours post meal||1.39|0.69|
91657618|NCT03952143|183208507|SUPERIORITY||Relative rate|1.15|||||TWO_SIDED|95.0|0.84|1.57||||||For ≤4 hours post meal||1.57|0.84|
91657619|NCT03952143|183208508|SUPERIORITY||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.1|0.53||||||||0.53|-1.10|
91657620|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|2.2|||||TWO_SIDED|95.0|-2.8|7.2||||||For Morning Premeal||7.2|-2.8|
91657621|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.6|2.0||||||For Morning 1-hour Postmeal||2.0|-12.6|
91657622|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|-5.4|||||TWO_SIDED|95.0|-12.5|1.7||||||For Morning 2-hour Postmeal||1.7|-12.5|
91712836|NCT01111565|183317415|SUPERIORITY||Treatment Difference|0.1|||=|0.91|TWO_SIDED|95.0|-1.8|2.1|||ANCOVA|||||2.1|-1.8|=0.910
91657623|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|4.2|||||TWO_SIDED|95.0|-1.8|10.1||||||For Midday Premeal||10.1|-1.8|
91657624|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|1.2|||||TWO_SIDED|95.0|-5.7|8.1||||||For Midday 1-hour Postmeal||8.1|-5.7|
91657625|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|1.9|||||TWO_SIDED|95.0|-5.1|8.9||||||For Midday 2-hour Postmeal||8.9|-5.1|
91524431|NCT02799472|182923978|OTHER||Ratio|1.12||||0.717|TWO_SIDED|95.0|0.597|2.101|||Repeated measures analysis|||CMDV, Week 4||2.101|0.597|0.717
91617857|NCT03453151|183128470|OTHER|||||||0.069|||||||Paired t-test|This analysis refers to the peak exercise cardiac index.||||||0.069
91617858|NCT03453151|183128472|OTHER|||||||0.25|||||||Paired t-test|This analysis refers to creatinine level.||||||0.250
91617859|NCT03453151|183128472|OTHER|||||||0.014|||||||Paired t-test|This analysis refers to BUN level.||||||0.014
91617860|NCT02592629|183128481|EQUIVALENCE|ANOVA|||||<|0.05|||||||ANOVA|||||||<0.05
91617861|NCT03229759|183128482|SUPERIORITY||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.88|2.08||||||Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.08|0.88|
91617862|NCT03229759|183128482|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.72|1.96||||||Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||1.96|0.72|
91617863|NCT03229759|183128482|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.38|2.47||||||Groin||2.47|1.38|
91617864|NCT03229759|183128482|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|0.73|1.79||||||Groin||1.79|0.73|
91617865|NCT00762372|183128489|NON_INFERIORITY|Time to extubation = treatment group + surgical site +surgery time|Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-6.6|-2.7||||||||-2.7|-6.6|
91617866|NCT00762372|183128490|NON_INFERIORITY|"Adjusted means of time from the end of study drug inhalation to extubation in the BLM-240 N2O group and sevoflurane group, which were obtained by analysis of covariance with surgical site and surgery time as covariates, were used to verify the non-inferiority of BLM-240 to the comparator sevoflurane, with a delta = 1.0 (minute) and significance level alpha = 2.5% (one-sided)."||||||0.15|||||||t-test, 2 sided|||||||0.1500
91617867|NCT00762372|183128491|NON_INFERIORITY|Two-sample t-test||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91617868|NCT00762372|183128495|NON_INFERIORITY|Fisher's exact test||||||0.3113|||||||Fisher Exact|||||||0.3113
91617869|NCT00762372|183128497|NON_INFERIORITY|Fisher's exact test||||||1|||||||Fisher Exact|||||||1.0000
91617870|NCT01194804|183128501|OTHER||||||<|0.001|||||||Sign test|||||||<0.001
91617871|NCT02670915|183128506|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.|Treatment difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|<0.001
91657626|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|14.1|||||TWO_SIDED|95.0|7.6|20.6||||||For Evening Premeal||20.6|7.6|
91657627|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-5.1|9.1||||||For Evening 1-hour Postmeal||9.1|-5.1|
91657628|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.8||||||For Evening 2-hour Postmeal||6.8|-7.3|
91657629|NCT03952143|183208509|SUPERIORITY||LS Mean Difference|1.7|||||TWO_SIDED|95.0|-4.7|8.1||||||For Bedtime||8.1|-4.7|
91657630|NCT03952143|183208510|SUPERIORITY||LS Mean Difference|2.8|||||TWO_SIDED|95.0|0.1|5.4||||||For Total Daily Insulin Dose||5.4|0.1|
91657631|NCT03952143|183208510|SUPERIORITY||LS Mean Difference|0.8|||||TWO_SIDED|95.0|0.0|1.5||||||For Daily Basal Insulin Dose||1.5|0.0|
91657632|NCT03952143|183208510|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-0.5|4.5||||||For Daily Prandial Insulin Dose||4.5|-0.5|
91657633|NCT03952143|183208511|SUPERIORITY||Odds Ratio (OR)|1.02||||0.924|TWO_SIDED|95.0|0.69|1.52|||Regression, Logistic|||For HbA1c \< 7%||1.52|0.69|0.924
91657634|NCT03952143|183208511|SUPERIORITY||Odds Ratio (OR)|0.98||||0.908|TWO_SIDED|95.0|0.64|1.49|||Regression, Logistic|||For HbA1c ≤6.5%||1.49|0.64|0.908
91712837|NCT01111565|183317415|SUPERIORITY||Treatment Difference|-1.0|||=|0.291|TWO_SIDED|95.0|-3.0|0.9|||ANCOVA|||||0.9|-3.0|=0.291
91791510|NCT00579436|183460776|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91791511|NCT00579436|183460777|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
91791512|NCT00579436|183460778|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
91791513|NCT01203852|183460838|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test of mean change in blood pressure before and after treatment with metoprolol and chlorthalidone were \<0.0001.|t-test, 1 sided|||||||<0.0001
91791514|NCT01203852|183460839|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with chlorthalidone was \<0.0001.|t-test, 1 sided|||Mean glucose change after treatment with chlorthalidone||||<0.0001
91791515|NCT01203852|183460839|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with metoprolol was 0.049.|t-test, 1 sided|||Mean glucose change after treatment with metoprolol||||0.049
91791516|NCT00899392|183460840|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Student's t test|t-test, 2 sided|||||||<0.0001
91791517|NCT00899392|183460841|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann Whitney Test-non parametric||||>0.05
91617872|NCT02670915|183128506|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.|Treatment difference|0.13|||<|0.001|TWO_SIDED|95.0|-0.01|0.26||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||0.26|-0.01|<0.001
91617873|NCT02670915|183128506|SUPERIORITY|Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.|Treatment difference|-0.17|||=|0.007|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for superiority evaluated at the 2.5% level.|multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|=0.007
91617874|NCT00818207|183128586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0007|TWO_SIDED|95.0|1.23|2.18|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.18|1.23|0.0007
91617875|NCT00818207|183128587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0018|TWO_SIDED|95.0|1.21|2.33|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.33|1.21|0.0018
91617876|NCT00818207|183128588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.2979|TWO_SIDED|95.0|0.82|1.9||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.90|0.82|0.2979
91617877|NCT00818207|183128588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4388|TWO_SIDED|95.0|0.76|1.87||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.87|0.76|0.4388
91617878|NCT00818207|183128589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.0001|TWO_SIDED|95.0|1.35|2.2||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.20|1.35|<0.0001
91617879|NCT00818207|183128590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.4551|TWO_SIDED|95.0|0.81|1.62||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.62|0.81|0.4551
91791518|NCT00899392|183460842|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|paired||||||>0.05
91524432|NCT02799472|182923978|OTHER||Ratio|0.661||||0.227|TWO_SIDED|95.0|0.333|1.31|||Repeated measures analysis|||CMDV, Week 6||1.310|0.333|0.227
91617880|NCT00967226|183128655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.05||0.77|||||||t-test, 2 sided|||intention to treat analysis||||0.77
91617881|NCT01670656|183128668|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.2|||cLDA|||||-0.2|-1.0|< 0.001
91617882|NCT01670656|183128668|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
91617883|NCT01670656|183128668|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||cLDA|||||-0.4|-1.1|< 0.001
91617884|NCT01670656|183128668|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
91617885|NCT01670656|183128669|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.7|||=|0.002|TWO_SIDED|95.0|-3.0|-0.4|||cLDA|||||-0.4|-3.0|= 0.002
91617886|NCT01670656|183128669|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.9|||<|0.001|TWO_SIDED|95.0|-3.1|-0.6|||cLDA|||||-0.6|-3.1|< 0.001
91617887|NCT01670656|183128669|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.003|TWO_SIDED|95.0|-2.9|-0.3|||cLDA|||||-0.3|-2.9|= 0.003
91617888|NCT01670656|183128669|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.2|||=|0.024|TWO_SIDED|95.0|-2.5|0.1|||cLDA|||||0.1|-2.5|= 0.024
91617889|NCT01670656|183128670|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.026|TWO_SIDED|95.0|-3.4|0.2|||cLDA|||||0.2|-3.4|= 0.026
91617890|NCT01670656|183128670|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.5|||=|0.036|TWO_SIDED|95.0|-3.3|0.2|||cLDA|||||0.2|-3.3|= 0.036
91617891|NCT01670656|183128670|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-2.3|||=|0.002|TWO_SIDED|95.0|-4.1|-0.5|||cLDA|||||-0.5|-4.1|= 0.002
91617892|NCT01670656|183128670|SUPERIORITY_OR_OTHER_LEGACY||Diffference in Least Squares Means|-1.2|||=|0.1|TWO_SIDED|95.0|-3.0|0.6|||cLDA|||||0.6|-3.0|= 0.1
91617893|NCT01670656|183128671|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.1|||=|0.447|TWO_SIDED|95.0|-0.6|0.3|||cLDA|||||0.3|-0.6|= 0.447
91617894|NCT01670656|183128671|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
91791519|NCT00899392|183460843|SUPERIORITY_OR_OTHER|||||||0.0053||95.0|||||t-test, 2 sided|||||||0.0053
91791520|NCT02589600|183460845|SUPERIORITY||Incident Rate Ratio|1.05||||0.7251|TWO_SIDED|95.0|0.9|1.22|||Negative binomial regression||Placebo group is the reference group||Negative binomial regression implemented in the SAS®️ GENMOD procedure with fracture outcome as the dependent variable; duration of follow-up as an offset to account for each participant's exposure; treatment arm as the main independent factor of interest.|1.22|.90|0.7251
91712838|NCT03150082|183317416|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.88|||||TWO_SIDED|90.0|91.13|103.0|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.00|91.13|
91712839|NCT03150082|183317417|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|93.16|||||TWO_SIDED|90.0|86.09|100.82|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||100.82|86.09|
91712840|NCT03150082|183317418|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.96|||||TWO_SIDED|90.0|91.17|103.11|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.11|91.17|
91712841|NCT03150082|183317419|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.||||||0.3499||||||"P value was analyzed using a nonparametric Wilcoxon signed-rank test."|Wilcoxon signed-rank test|||||||0.3499
91617895|NCT01670656|183128671|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
91617896|NCT01670656|183128671|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.3|||=|0.156|TWO_SIDED|95.0|-0.7|0.2|||cLDA|||||0.2|-0.7|= 0.156
91712842|NCT02363387|183317441|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|2.7|18.8|||Regression, Logistic|||||18.8|2.7|<0.001
91617897|NCT00165841|183128672|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was adjusted for multiple comparisons.|t-test, 2 sided|The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.||Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.||||<0.0001
91617898|NCT00487084|183128682|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Log Rank|||A sample of 56 was estimated to have an 80% power to detect a 30% difference in the proportion of subjects with continuing analgesia in the MCS versus the SCM groups when 50% of the subjects in the SCM had requested supplemental analgesia. 28 subjects was added to compare the influence of time of morphine and 2-chloroprocaine administration to lidocaine-morphine analgesia. The primary outcome was compared using Kaplan-Meier survival analysis and the log-rank test.||||0.006
91617899|NCT00487084|183128682|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Log Rank|||||||0.83
91712843|NCT00357877|183317478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.56|TWO_SIDED|95.0|-0.6|1.11||No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.|Regression, Linear|The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.||We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.||1.11|-0.60|0.56
91712844|NCT00357877|183317479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.57||0.54|TWO_SIDED|95.0|-0.77|1.46||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables and age and age-squared as continuous covariates.||hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.||1.46|-0.77|0.54
91524433|NCT02799472|182923978|OTHER||Ratio|0.817||||0.471|TWO_SIDED|95.0|0.464|1.437|||Repeated measures analysis|||CMDV, Week 8||1.437|0.464|0.471
91617900|NCT00487084|183128682|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Log Rank|||||||0.009
91617901|NCT00487084|183128683|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
91617902|NCT00487084|183128683|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
91617903|NCT00487084|183128684|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
91617904|NCT00487084|183128684|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
91657635|NCT01866319|183208513|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.46|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.46|<0.00001
91657636|NCT01866319|183208513|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.47|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.47|<0.00001
91617905|NCT00487084|183128685|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared, Corrected|||||||0.20
91617906|NCT01830543|183128714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.001
91617907|NCT01830543|183128714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.8|||Log Rank|||||0.8|0.5|<0.001
91617908|NCT01830543|183128715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.234|TWO_SIDED|95.0|0.33|1.31|||Log Rank|||||1.31|0.33|0.234
91617909|NCT01830543|183128715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.114|TWO_SIDED|95.0|0.28|1.16|||Log Rank|||||1.16|0.28|0.114
91617910|NCT01830543|183128716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.144|TWO_SIDED|95.0|0.2|1.28|||Log Rank|||||1.28|0.2|0.144
91617911|NCT01830543|183128716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5||||0.134|TWO_SIDED|95.0|0.2|1.26|||Log Rank|||||1.26|0.2|0.134
91617912|NCT01830543|183128717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.8|0.47|<0.001
91617913|NCT01830543|183128717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.002|TWO_SIDED|95.0|0.52|0.86|||Log Rank|||||0.86|0.52|0.002
91617914|NCT01830543|183128718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|95.0|0.69|1.68|||Log Rank|||||1.68|0.69|0.75
91617915|NCT01830543|183128718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.765|TWO_SIDED|95.0|0.59|1.48|||Log Rank|||||1.48|0.59|0.765
91617916|NCT01830543|183128719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.523|TWO_SIDED|95.0|0.59|2.8|||Log Rank|||||2.8|0.59|0.523
91657637|NCT01866319|183208513|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.75869|TWO_SIDED|95.0|0.77|1.21|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||1.21|0.77|0.75869
91657638|NCT01866319|183208514|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.00052|TWO_SIDED|95.0|0.47|0.83|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.83|0.47|0.00052
91657639|NCT01866319|183208514|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.00358|TWO_SIDED|95.0|0.52|0.9|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.90|0.52|0.00358
91617917|NCT01830543|183128719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.664|TWO_SIDED|95.0|0.54|2.62|||Log Rank|||||2.62|0.54|0.664
91617918|NCT01830543|183128720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.625|TWO_SIDED|95.0|0.46|1.59|||Log Rank|||||1.59|0.46|0.625
91617919|NCT01830543|183128720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.374|TWO_SIDED|95.0|0.4|1.42|||Log Rank|||||1.42|0.4|0.374
91617920|NCT01830543|183128721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.891|TWO_SIDED|95.0|0.39|2.96|||Log Rank|||||2.96|0.39|0.891
91617921|NCT01830543|183128721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||0.53|TWO_SIDED|95.0|0.52|3.58|||Log Rank|||||3.58|0.52|0.53
91657640|NCT01866319|183208514|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.51319||95.0|0.67|1.22|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||1.22|0.67|0.51319
91657641|NCT01866319|183208515|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|16.1||||0.00013|TWO_SIDED|95.0|7.8|24.5|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||24.5|7.8|0.00013
91657642|NCT01866319|183208515|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|17.2||||2e-05|TWO_SIDED|95.0|9.5|25.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||25.6|9.5|0.00002
91657643|NCT01866319|183208515|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-1.1||||0.82636||95.0|-10.6|8.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||8.6|-10.6|0.82636
91617922|NCT01830543|183128722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.79|TWO_SIDED|95.0|0.32|4.45|||Log Rank|||||4.45|0.32|0.79
91617923|NCT01830543|183128722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.574|TWO_SIDED|95.0|0.4|5.09|||Log Rank|||||5.09|0.4|0.574
91617924|NCT01151046|183128727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.003|TWO_SIDED|95.0|0.11|0.63|||Log Rank|||||0.63|0.11|0.003
91617925|NCT01151046|183128727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.349|TWO_SIDED|95.0|0.69|2.88|||Log Rank|||||2.88|0.69|0.349
91617926|NCT00839423|183128764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-8.49|-2.91||"A hierarchical hypothesis testing procedure was used. The comparison of 10 mg to placebo was primary.~Since p-value was \<0.05, hierarchically testing continued."|ANCOVA|||"The statistical model was an analysis of covariance (ANCOVA) of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 6.~With 96 patients in each treatment arm and a standard deviation of 9 points, the power to detect a true effect of 3.7 points on the MADRS total score at Week 6 will be 80%."||-2.91|-8.49|<0.0001
91524434|NCT02799472|182923978|OTHER||Ratio|0.816||||0.541|TWO_SIDED|95.0|0.417|1.597|||Repeated measures analysis|||CMDV, Week 12||1.597|0.417|0.541
91617927|NCT00839423|183128764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.64|-3.17||"The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo.~Since p-value \<0.05, hierarchically testing contd."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6."||-3.17|-8.64|<0.0001
91657644|NCT01328093|183208530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||<0.001
91657645|NCT01328093|183208531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||P-value is for ≥7% increase.|Cochran-Mantel-Haenszel|||||||0.110
91657646|NCT01328093|183208531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value is for ≥7% decrease.|Cochran-Mantel-Haenszel|||||||<0.001
91657647|NCT01328093|183208532|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.353||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.353
91657648|NCT01328093|183208533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.698||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.698
91657649|NCT01328093|183208534|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.924||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.924
91657650|NCT01328093|183208535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.55|STANDARD_ERROR_OF_MEAN|1.77||0.045||95.0||||P-value is for PANSS Total Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.045
91657651|NCT01328093|183208535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.21|STANDARD_ERROR_OF_MEAN|0.56||0.032||95.0||||P-value is for PANSS Positive Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.032
91791521|NCT01143701|183460857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54|||<|0.05|TWO_SIDED|95.0|-5.89|-1.19|||Mixed Models Analysis|||Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||-1.19|-5.89|<.05
91617928|NCT00839423|183128764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.13|-3.72||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.72|-9.13|<0.0001
91617929|NCT00839423|183128765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.69||0.2377|TWO_SIDED|95.0|-2.17|0.54||"The hierarchical procedure meant that the above hypothesis was tested at a 5% significance level since significance was achieved for both 10 and 5 mg at Week 6.~Since p-value was \>0.05, hierarchically testing stopped here."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 1."||0.54|-2.17|0.2377
91617930|NCT00839423|183128765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.67||0.7489|TWO_SIDED|95.0|-1.54|1.11||The hierarchical procedure meant that the above hypothesis was not tested since significance was not achieved for 10 mg at Week 1. A nominal p-value is provided.|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 1."||1.11|-1.54|0.7489
91617931|NCT00839423|183128765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.67||0.4142|TWO_SIDED|95.0|-0.77|1.85||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||1.85|-0.77|0.4142
91617932|NCT00839423|183128766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|-7.69|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.69|<0.0001
91617933|NCT00839423|183128766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.33|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-7.79|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.79|<0.0001
91617934|NCT00839423|183128767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|-5.27|-1.33||A nominal p-value is provided.|ANCOVA|||||-1.33|-5.27|0.0011
91617935|NCT00839423|183128767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.02||0.0034|TWO_SIDED|95.0|-5.01|-1.0||A nominal p-value is provided.|ANCOVA|||||-1.00|-5.01|0.0034
91617936|NCT00839423|183128768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.28|-0.52||A nominal p-value is provided.|ANCOVA|||||-0.52|-1.28|<0.0001
91617937|NCT00839423|183128768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.34|-0.56||A nominal p-value is provided.|ANCOVA|||||-0.56|-1.34|<0.0001
91617938|NCT00839423|183128769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.90|0.0003
91617939|NCT00839423|183128769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.92|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.92|0.0003
91617940|NCT00839423|183128770|SUPERIORITY_OR_OTHER||Difference %|21.9||||0.002|TWO_SIDED|95.0|8.89|34.92||A nominal p-value is provided.|Fisher Exact|||||34.92|8.89|0.002
91657652|NCT01328093|183208535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.36|STANDARD_ERROR_OF_MEAN|0.54||0.509||95.0||||P-value is for PANSS Negative Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.509
91524435|NCT02799472|182923978|OTHER||Ratio|0.822||||0.544|TWO_SIDED|95.0|0.422|1.602|||Repeated measures analysis|||CMDV, 12-Week FU||1.602|0.422|0.544
91617941|NCT00839423|183128770|SUPERIORITY_OR_OTHER||Difference %|23.34||||0.001|TWO_SIDED|95.0|10.05|36.43||A nominal p-value is provided.|Fisher Exact|||||36.43|10.05|0.001
91617942|NCT00839423|183128771|SUPERIORITY_OR_OTHER||Difference %|22.41||||0.001|TWO_SIDED|95.0|9.74|35.07||A nominal p-value is provided.|Fisher Exact|||||35.07|9.74|0.001
91617943|NCT00839423|183128771|SUPERIORITY_OR_OTHER||Difference %|22.33||||0.001|TWO_SIDED|95.0|9.39|35.28||A nominal p-value is provided.|Fisher Exact|||||35.28|9.39|0.001
91617944|NCT03377244|183128780|SUPERIORITY|||||||0.1013||||||The p-value above reflects results of between-arms analysis of percent change in weight from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1013
91617945|NCT03377244|183128781|SUPERIORITY|||||||0.495||||||The p-value above reflects results of between-arms analysis of change in mean HbA1c from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment.||||||0.4950
91617946|NCT03377244|183128782|SUPERIORITY|||||||0.7416||||||The p-value above reflects results of between-arms analysis of change in systolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.7416
91617947|NCT03377244|183128783|SUPERIORITY|||||||0.0702||||||The p-value above reflects results of between-arms analysis of change in diastolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0702
91657653|NCT01328093|183208535|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.05|STANDARD_ERROR_OF_MEAN|1.0||0.04||95.0||||P-value is for PANSS General Psychopathology Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.040
91617948|NCT03377244|183128784|SUPERIORITY|||||||0.007||||||The p-value above reflects results of between-arms analysis of change in eating habits self-efficacy scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0070
91617949|NCT03377244|183128785|SUPERIORITY|||||||0.0009||||||The p-value above reflects results of between-arms analysis of change in physical activity self-efficacy scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0009
91617950|NCT03377244|183128786|SUPERIORITY|||||||0.374||||||The p-value above reflects results of between-arms analysis for the probability of participants to engage in sufficient physical activity at 6 months post-intervention.|Regression, Logistic|Model adjusted for age, sex, education, marital status, employment status, and baseline physical activity.||||||0.3740
91617951|NCT03377244|183128787|SUPERIORITY|||||||0.9556||||||The p-value above reflects results of between-arms analysis of change in participants' sugar-sweetened beverage consumption per day from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.9556
91617952|NCT03377244|183128788|SUPERIORITY|||||||0.1726||||||The p-value above reflects results of between-arms analysis of change in participants' fruit and vegetable consumption scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1726
91617953|NCT03377244|183128789|SUPERIORITY|||||||0.0478||||||The p-value above reflects results of between-arms analysis of change in participants' family support scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0478
91617954|NCT04348656|183128797|SUPERIORITY||Risk Ratio (RR)|1.16||||0.18|TWO_SIDED|95.0|0.94|1.43|||wald test|||||1.43|0.94|0.18
91617955|NCT04348656|183128798|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.47|||Regression, Cox|||||1.47|0.89|0.30
91617956|NCT04348656|183128799|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.7|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||0.7|-2.1|0.41
91617957|NCT04348656|183128800|SUPERIORITY||Risk Ratio (RR)|1.12||||0.4|TWO_SIDED|95.0|0.86|1.46|||wald test|||||1.46|0.86|0.40
91617958|NCT04348656|183128801|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.22|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided|||||1.7|-0.3|0.22
91617959|NCT04348656|183128802|SUPERIORITY||Risk Ratio (RR)|0.83||||0.72|TWO_SIDED|95.0|0.31|2.27|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||2.27|0.31|0.72
91617960|NCT04348656|183128805|SUPERIORITY||Risk Ratio (RR)|1.13||||0.33|TWO_SIDED|95.0|0.88|1.45|||wald test|||||1.45|0.88|0.33
91617961|NCT04348656|183128806|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.91|TWO_SIDED|95.0|0.76|1.35|||Regression, Cox|competing risk analysis|competing risk analysis|||1.35|0.76|0.91
91657654|NCT01328093|183208536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.1|STANDARD_ERROR_OF_MEAN|2.1||0.601||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.601
91712845|NCT00357877|183317480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.18|TWO_SIDED|95.0|-1.25|0.23||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|treatment and site included as class variables and age and age-squared as continuous covariates.||Hypothesized lower increment in active arm, though hypothesis testing was two-sided.||0.23|-1.25|0.18
91617962|NCT04348656|183128807|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.18|TWO_SIDED|95.0|0.8|1.04|||Regression, Cox|||||1.04|0.80|0.18
91617963|NCT04348656|183128808|SUPERIORITY||Risk Ratio (RR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.26|||wald test|||||2.26|1.04|0.03
91617964|NCT04348656|183128808|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.02|TWO_SIDED|95.0|1.08|2.69|||Regression, Cox|competing risk analysis|competing risk analysis|The cumulative incidence of Grade 3 and 4 serious AEs is described as a hazard ratio.||2.69|1.08|0.02
91617965|NCT04348656|183128810|SUPERIORITY||Risk Ratio (RR)|1.27||||0.03|TWO_SIDED|95.0|1.02|1.57|||wald test|||||1.57|1.02|0.03
91617966|NCT04348656|183128813|OTHER|Incremental cost per quality-adjusted life day gained (ICER)- this is a summary measure of the cost-effectiveness of the intervention, compared to the control group. This is calculated using the cost (derived from cost of the intervention and cost of hospital stay based on the payer's perspective) per patient and the quality-adjusted life days calculated using the EQ-5D-5L results.|ICER (CAD)|-44623.01|||||TWO_SIDED|95.0|-525369.24|436123.22|||||ICER is reported in Canadian dollars. 95% CI is calculated by 1000 bootstrap sampling using bias-corrected accelerated method.|||436123.22|-525369.24|
91617967|NCT00922194|183128821|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.36|STANDARD_DEVIATION|3.3|<|0.05||95.0|-9.03|-7.72|||Paired t test|||Analysis of difference between 12 months or more and baseline values||-7.72|-9.03|<0.05
91617968|NCT00922194|183128822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.27|||<|0.05||95.0|-3.5|-3.0|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months or more and baseline values||-3.0|-3.5|<0.05
91617969|NCT00922194|183128823|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.41|||<|0.05||95.0|-8.37|-6.47|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-6.47|-8.37|<0.05
91657655|NCT01328093|183208537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.322||95.0||||P-value is for ER/Facility (Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.322
91657656|NCT01328093|183208537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.099||95.0||||P-value is for ER/Facility (Non-Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.099
91617970|NCT00922194|183128824|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.014|||<|0.05||95.0|-0.02|0.001|||Wilcoxon paired sign rank-sum test|||Analysis of difference between 12 months or more and baseline values||0.001|-0.02|<0.05
91617971|NCT00922194|183128825|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.61|||<|0.05||95.0|-5.2|-3.8|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-3.8|-5.2|<0.05
91617972|NCT00922194|183128826|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.97|||<|0.05||95.0|-3.57|-2.38|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.38|-3.57|<0.05
91617973|NCT00922194|183128827|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.37|||<|0.05||95.0|-2.65|-2.08|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.08|-2.65|<0.05
91617974|NCT05142332|183128828|SUPERIORITY||Adjusted absolute difference|11.9|||<|0.001|TWO_SIDED|95.0|4.5|19.3|||Regression, Logistic|||||19.3|4.5|<0.001
91617975|NCT05142332|183128829|SUPERIORITY||Adjusted absolute difference|7.9|||<|0.001|TWO_SIDED|95.0|1.7|14.1|||Regression, Logistic|||||14.1|1.7|<0.001
91617976|NCT05906732|183128882|SUPERIORITY||LS Mean|-9.6||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0030
91617977|NCT05906732|183128883|SUPERIORITY||LS Mean|-6.5||||0.0266|TWO_SIDED||||||Mixed Models Analysis|||||||0.0266
91617978|NCT05906732|183128884|SUPERIORITY||LS Mean|-7.8||||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
91617979|NCT05906732|183128885|SUPERIORITY||LS Mean|-3.9||||0.1106|TWO_SIDED||||||Mixed Models Analysis|||||||0.1106
91617980|NCT05906732|183128886|SUPERIORITY||LS Mean|-4.2||||0.0908|TWO_SIDED||||||Mixed Models Analysis|||||||0.0908
91657657|NCT01328093|183208537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.787||95.0||||P-value is for Outpatient (Non-Psych or Dentist) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.787
91657658|NCT01328093|183208538|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.892||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.892
91617981|NCT05906732|183128887|SUPERIORITY||LS Mean|-1.2||||0.4038|TWO_SIDED||||||Mixed Models Analysis|||||||0.4038
91617982|NCT05906732|183128888|SUPERIORITY||LS Mean|1.5||||0.6255|TWO_SIDED||||||Mixed Models Analysis|||||||0.6255
91617983|NCT05906732|183128889|SUPERIORITY||LS Mean|0.2||||0.514|TWO_SIDED||||||Mixed Models Analysis|||||||0.5140
91617984|NCT05906732|183128890|SUPERIORITY||LS Mean|0.8||||0.5675|TWO_SIDED||||||Mixed Models Analysis|||||||0.5675
91617985|NCT05906732|183128891|SUPERIORITY||LS Mean|3.4||||0.764|TWO_SIDED||||||Mixed Models Analysis|||||||0.7640
91617986|NCT05906732|183128892|SUPERIORITY||LS Mean|-2.8||||0.2437|TWO_SIDED||||||Mixed Models Analysis|||||||.2437
91617987|NCT05906732|183128893|SUPERIORITY||LS Mean|-0.8||||0.4229|TWO_SIDED||||||Mixed Models Analysis|||||||0.4229
91617988|NCT05906732|183128894|SUPERIORITY||LS Mean|-0.1||||0.4887|TWO_SIDED||||||Mixed Models Analysis|||||||0.4887
91617989|NCT05906732|183128895|SUPERIORITY||LS Mean|-3.1||||0.2042|TWO_SIDED||||||Mixed Models Analysis|||||||0.2042
91617990|NCT05906732|183128896|SUPERIORITY||Mean Difference (Net)|-2.2||||0.2644|TWO_SIDED||||||Mixed Models Analysis|||||||0.2644
91617991|NCT05906732|183128914|SUPERIORITY||Mean Difference (Net)|4.28||||0.3169|TWO_SIDED||||||t-test, 2 sided|||||||0.3169
91617992|NCT05906732|183128915|SUPERIORITY||Mean Difference (Net)|6.78||||0.1066|TWO_SIDED||||||t-test, 2 sided|||||||0.1066
91617993|NCT05906732|183128916|SUPERIORITY||Mean Difference (Net)|-16.06||||0.0443|TWO_SIDED||||||t-test, 2 sided|||||||0.0443
91617994|NCT05906732|183128917|SUPERIORITY||Mean Difference (Net)|-9.06||||0.0815|TWO_SIDED||||||t-test, 2 sided|||||||0.0815
91617995|NCT05906732|183128918|SUPERIORITY||Mean Difference (Net)|-10.67||||0.0137|TWO_SIDED||||||t-test, 2 sided|||||||0.0137
91617996|NCT05906732|183128919|SUPERIORITY||Mean Difference (Net)|-4.0||||0.3539|TWO_SIDED||||||t-test, 2 sided|||||||0.3539
91617997|NCT05906732|183128920|SUPERIORITY||Mean Difference (Net)|9.78||||0.1377|TWO_SIDED||||||t-test, 2 sided|||||||0.1377
91657659|NCT01328093|183208539|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.63||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.630
91657660|NCT01328093|183208540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.679||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.679
91657661|NCT01328093|183208541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.055||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.055
91657662|NCT01328093|183208542|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|1.11||0.891||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.891
91617998|NCT05906732|183128921|SUPERIORITY||Mean Difference (Net)|-2.69||||0.6184|TWO_SIDED||||||t-test, 2 sided|||||||0.6184
91617999|NCT05906732|183128922|SUPERIORITY||Mean Difference (Net)|3.17||||0.6627|TWO_SIDED||||||t-test, 2 sided|||||||0.6627
91618000|NCT05906732|183128923|SUPERIORITY||Mean Difference (Net)|5.78||||0.5276|TWO_SIDED||||||t-test, 2 sided|||||||0.5276
91618001|NCT05906732|183128924|SUPERIORITY||Mean Difference (Net)|15.17||||0.0399|TWO_SIDED||||||t-test, 2 sided|||||||0.0399
91618002|NCT05906732|183128925|SUPERIORITY||Mean Difference (Net)|13.56||||0.0747|TWO_SIDED||||||t-test, 2 sided|||||||0.0747
91618003|NCT05906732|183128926|SUPERIORITY|||||||0.9584|||||||t-test, 2 sided|||||||0.9584
91618004|NCT05906732|183128927|SUPERIORITY||Mean Difference (Net)|5.72||||0.6531|TWO_SIDED||||||t-test, 2 sided|||||||0.6531
91618005|NCT05906732|183128928|SUPERIORITY||Mean Difference (Net)|15.61||||0.0482|TWO_SIDED||||||t-test, 2 sided|||||||0.0482
91618006|NCT05906732|183128929|SUPERIORITY||Mean Difference (Net)|17.22||||0.0667|TWO_SIDED||||||t-test, 2 sided|||||||0.0667
91618007|NCT05906732|183128930|SUPERIORITY||Mean Difference (Net)|-37.0||||0.0131|TWO_SIDED||||||t-test, 2 sided|||||||0.0131
91618008|NCT05906732|183128931|SUPERIORITY||Mean Difference (Net)|-32.36||||0.0141|TWO_SIDED||||||t-test, 2 sided|||||||0.0141
91618009|NCT05906732|183128932|SUPERIORITY||Mean Difference (Net)|-44.55||||0.0019|TWO_SIDED||||||t-test, 2 sided|||||||0.0019
91657663|NCT01328093|183208544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||P-value is for Treatment-Emergent Suicidal Ideation.|Fisher Exact|||||||0.064
91618010|NCT05906732|183128933|SUPERIORITY||Mean Difference (Net)|-31.69||||0.1108|TWO_SIDED||||||t-test, 2 sided|||||||0.1108
91618011|NCT05906732|183128934|SUPERIORITY||Mean Difference (Net)|37.81||||0.184|TWO_SIDED||||||t-test, 2 sided|||||||0.1840
91618012|NCT05906732|183128935|SUPERIORITY||Mean Difference (Net)|27.33||||0.2019|TWO_SIDED||||||t-test, 2 sided|||||||0.2019
91618013|NCT05906732|183128936|SUPERIORITY|||||||0.2808|||||||t-test, 2 sided|||||||0.2808
91618014|NCT05906732|183128937|SUPERIORITY||Mean Difference (Net)|110.39||||0.1644|TWO_SIDED||||||t-test, 2 sided|||||||0.1644
91618015|NCT05906732|183128938|SUPERIORITY||Mean Difference (Net)|-44.29||||0.0282|TWO_SIDED||||||t-test, 2 sided|||||||0.0282
91618016|NCT05906732|183128939|SUPERIORITY||Mean Difference (Net)|-37.87||||0.0306|TWO_SIDED||||||t-test, 2 sided|||||||0.0306
91618017|NCT05906732|183128940|SUPERIORITY||Mean Difference (Net)|-53.42||||0.0016|TWO_SIDED||||||t-test, 2 sided|||||||0.0016
91618018|NCT05906732|183128941|SUPERIORITY||Mean Difference (Net)|-44.25||||0.1378|TWO_SIDED||||||t-test, 2 sided|||||||0.1378
91618019|NCT04026412|183128953|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.646|TWO_SIDED|96.0|0.77|1.19|||Cox proportional hazards model|||||1.19|0.77|0.6460
91618020|NCT04026412|183128954|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.87|1.41||||||||1.41|0.87|
91618021|NCT04026412|183128954|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.75|1.22||||||||1.22|0.75|
91618022|NCT04026412|183128954|SUPERIORITY||Hazard Ratio, log|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
91618023|NCT04026412|183128955|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
91618024|NCT04026412|183128955|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.93|1.42||||||||1.42|0.93|
91618025|NCT04026412|183128956|SUPERIORITY||Difference in ORR|3.2|||||TWO_SIDED|95.0|-4.1|10.6||||||||10.6|-4.1|
91618026|NCT04026412|183128956|SUPERIORITY||Difference in ORR|7.8|||||TWO_SIDED|95.0|0.7|14.8||||||||14.8|0.7|
91618027|NCT04026412|183128956|SUPERIORITY||Difference in ORR|-4.7|||||TWO_SIDED|95.0|-11.8|2.5||||||||2.5|-11.8|
91618028|NCT04026412|183128959|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||||1.23|0.82|
91618029|NCT04026412|183128959|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.7|1.05||||||||1.05|0.70|
91618030|NCT04026412|183128959|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.44||||||||1.44|0.95|
91618031|NCT04026412|183128960|SUPERIORITY||Difference in ORR|3.5|||||TWO_SIDED|95.0|-4.1|11.1||||||||11.1|-4.1|
91618032|NCT04026412|183128960|SUPERIORITY||Difference in ORR|5.4|||||TWO_SIDED|95.0|-2.0|12.9||||||||12.9|-2.0|
91618033|NCT04026412|183128960|SUPERIORITY||Difference in ORR|-1.9|||||TWO_SIDED|95.0|-9.5|5.6||||||||5.6|-9.5|
91618034|NCT04026412|183128963|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.76|1.23||||||||1.23|0.76|
91618035|NCT04026412|183128963|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.65|1.06||||||||1.06|0.65|
91618036|NCT04026412|183128963|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.49||||||||1.49|0.91|
91618037|NCT00830037|183128966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.79|TWO_SIDED|95.0|-2.9|2.3||a = 0.05|Mixed Models Analysis|Wald test||The analysis of the primary outcome was intention to treat, if the patient received at least one dose of the randomized drug (which was the case for each subject). A linear mixed model was used with GFR as the outcome variable. Fixed effects were indicator variables for time (treated as a continuous variable), treatment, and their interaction. Random effects were subject and time with unstructured covariance; statistical inference was made using the maximum likelihood estimator.||2.3|-2.9|0.79
91657664|NCT01328093|183208544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||P-value is for Treatment-Emergent Suicidal Behavior.|Fisher Exact|||||||0.205
91657665|NCT04421508|183208546|SUPERIORITY||Odds Ratio (OR)|0.36||||0.6316|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.6316
91657666|NCT04421508|183208546|SUPERIORITY||Odds Ratio (OR)|1.502||||0.4127|TWO_SIDED|95.0|0.567|3.977||Odds ratio, 95% CI and p-value are from a logistic regression model modelling the response using the covariates treatment, age, number of co-morbidities and baseline oxygem level|Regression, Logistic|||||3.977|0.567|0.4127
91657667|NCT04421508|183208554|SUPERIORITY|||||||0.6635|||||||Chi-squared|||||||0.6635
91657668|NCT03980483|183208556|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0023|TWO_SIDED|0.95|1.19|2.21|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||2.21|1.19|0.0023
91618038|NCT00830037|183128967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.83|TWO_SIDED|95.0|-0.294|0.365||a = 0.05|Mixed Models Analysis|Wald test||The secondary analysis examined the mean change from baseline proteinuria (log protein to creatinine ratio) at 2 years. The between-groups difference in mean change from baseline is reported with a 95% confidence interval and the p-value from the Wald test.||0.365|-0.294|0.83
91618039|NCT04360187|183128980|SUPERIORITY||LS mean of difference|-17.13||||0.0002|TWO_SIDED|95.0|-25.98|-8.27|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-8.27|-25.98|0.0002
91618040|NCT04360187|183128984|SUPERIORITY||Risk Difference (RD)|12.9||||0.0124|TWO_SIDED|95.0|2.8|23.1|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||23.1|2.8|0.0124
91618041|NCT04360187|183128985|SUPERIORITY||Risk Difference (RD)|11.7||||0.0078|TWO_SIDED|95.0|3.1|20.3|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||20.3|3.1|0.0078
91618042|NCT04360187|183128986|SUPERIORITY||LS Mean of Difference|-0.79||||0.0009|TWO_SIDED|95.0|-1.26|-0.33|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-0.33|-1.26|0.0009
91524436|NCT02799472|182923978|OTHER||Ratio|1.051||||0.537|TWO_SIDED|95.0|0.895|1.233|||Repeated measures analysis|||MMP-Degraded CRP, Week 1||1.233|0.895|0.537
91618043|NCT00952289|183129046|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The primary endpoint analyzed with a 2-sided alpha of 0.05.||||<0.0001
91618044|NCT03259334|183129057|SUPERIORITY|||||||0.617|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.617
91618045|NCT03259334|183129057|SUPERIORITY|||||||0.018|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.018
91618046|NCT03259334|183129058|SUPERIORITY|||||||0.253|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.253
91618047|NCT03259334|183129058|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
91618048|NCT03259334|183129059|SUPERIORITY|||||||0.764|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.764
91618049|NCT03259334|183129059|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.080
91618050|NCT03259334|183129060|SUPERIORITY|||||||0.44|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.440
91618051|NCT03259334|183129060|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.002
91618052|NCT03259334|183129061|SUPERIORITY|||||||0.286|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.286
91618053|NCT03259334|183129061|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.005
91618054|NCT00777491|183129092|OTHER|There was no formal comparison of the two treatment arms.||||||||||||||||The confidence interval of the rate was calculated by Clopper-Pearson's exact binomial confidence intervals methods with one-sided type I error of 0.1. The study required 32 analyzable patients in each arm, which would warrant a 10% chance of observing a percentage of patients without distant metastasis by 3 years of less than 75% if the true rate was 86%. With the actual number of evaluable patients, the study instead warrants a 13-14% chance.|If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen.|||
91618055|NCT00777491|183129095|SUPERIORITY||Odds Ratio (OR)|0.493||||0.3|TWO_SIDED|95.0|0.129|1.881||Two-sided significance level of 0.05|Regression, Logistic|Univariate analysis|Reference arm = 5-FU and Cisplatin + BID Irradiation|||1.881|0.129|0.30
91618056|NCT00777491|183129096|SUPERIORITY||Odds Ratio (OR)|1.5||||0.75|TWO_SIDED|95.0|0.426|5.277||Two-sided significance level of 0.05|Regression, Logistic|Univariable analysis|Reference arm = 5-FU and Cisplatin + BID irradiation|||5.277|0.426|0.75
91618057|NCT02227329|183129101|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91618058|NCT02669862|183129142|OTHER|||||||0.555|||||||ANCOVA|Baseline values were the covariate||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.555
91712846|NCT00357877|183317481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_DEVIATION|0.57||0.24|TWO_SIDED|95.0|-1.8|0.45||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables, and age and age-squared as continuous covariates.||Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.||0.45|-1.80|0.24
91524437|NCT02799472|182923978|OTHER||Ratio|1.031||||0.635|TWO_SIDED|95.0|0.906|1.173|||Repeated measures analysis|||MMP-Degraded CRP, Week 2||1.173|0.906|0.635
91524438|NCT02799472|182923978|OTHER||Ratio|1.012||||0.866|TWO_SIDED|95.0|0.879|1.165|||Repeated measures analysis|||MMP-Degraded CRP, Week 4||1.165|0.879|0.866
91657669|NCT03980483|183208556|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0362|TWO_SIDED|0.95|1.02|1.89|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||1.89|1.02|0.0362
91618059|NCT02669862|183129142|OTHER|||||||0.009||||||PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.|ANCOVA|||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.009
91618060|NCT02669862|183129144|OTHER|||||||0.9313||||||Not adjusted for multiple comparisons|Chi-squared|||PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group||||0.9313
91618061|NCT02669862|183129144|OTHER|||||||0.0236||||||Not adjusted for multiple comparisons|Chi-squared|||||||0.0236
91618062|NCT00078559|183129181|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.1|||||TWO_SIDED|95.0|0.01|0.34|||95% Confidence Interval|Exact Binomial||||0.34|0.01|
91618063|NCT00078559|183129182|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
91618064|NCT00078559|183129183|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.7|||95% Confidence Interval|Exact Binomial||||0.7|0.0|
91618065|NCT00078559|183129186|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
91618066|NCT00078559|183129187|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial for all participants (n=10)||||0.3|0.0|
91657670|NCT03980483|183208556|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.0001|TWO_SIDED|0.95|1.62|3.37|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.37|1.62|<0.0001
91712847|NCT03570047|183317482|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.558|0.766|||Cox proportional hazards model|||||0.766|0.558|<0.0001
91618067|NCT00078559|183129188|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
91618068|NCT00078559|183129188|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
91618069|NCT00078559|183129189|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
91618070|NCT00078559|183129189|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
91618071|NCT01694420|183129198|SUPERIORITY_OR_OTHER||||||<|0.001||||||Study data compared to data as cited in PubMed ID: 21487250|Wilcoxon (Mann-Whitney)|||||||<0.001
91618072|NCT03621943|183129210|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||hierarchical generalized linear mixed mo|hierarchical generalized linear mixed models||Total score on the Ages and Stages Questionnaire, 3rd ed.||5.37|-6.36|0.87
91618073|NCT01716533|183129236|SUPERIORITY||GMC ratio|1.53||||0.5746|TWO_SIDED|95.0|0.33|7.14||P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA|ANOVA model -pooled variance.|GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||7.14|0.33|0.5746
91618074|NCT01716533|183129237|SUPERIORITY|ANOVA model -pooled variance.|GMC ratio|1.65||||0.7124|TWO_SIDED|95.0|0.1|26.41||P-value = two-sided p-value for HO: GMC ratio = 1, groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA||GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|Serum F2 C-terminal anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||26.41|0.10|0.7124
91618075|NCT01575197|183129248|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||||||0.014
91618076|NCT01575197|183129249|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
91618077|NCT01575197|183129250|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||t-test, 2 sided|||||||0.038
91618078|NCT01575197|183129251|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
91618079|NCT01000727|183129255|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.02|0.91|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.91|0.929
91618080|NCT01000727|183129256|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.777|TWO_SIDED|95.02|0.9|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.90|0.777
91618081|NCT01000727|183129257|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.274|TWO_SIDED|95.0|0.76|1.08||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.08|0.76|0.274
91657671|NCT03980483|183208556|SUPERIORITY||Odds Ratio (OR)|0.69||||0.023|TWO_SIDED|0.95|0.5|0.95|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.95|0.50|0.0230
91712848|NCT03570047|183317482|OTHER||Hazard Ratio (HR)|0.79||||0.0291|TWO_SIDED|95.0|0.642|0.977|||Cox proportional hazards model|||||0.977|0.642|0.0291
91657672|NCT03980483|183208556|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0013|TWO_SIDED|0.95|0.43|0.82|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.82|0.43|0.0013
91657673|NCT03980483|183208559|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5 % Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-10.4|||||TWO_SIDED|0.975|-18.6|-2.3|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-2.3|-18.6|
91657674|NCT03980483|183208559|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5% CI in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-13.0|||||TWO_SIDED|0.975|-21.2|-4.8|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-4.8|-21.2|
91657675|NCT05150964|183208654|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The hearing aid fitting prescription will have no effect on the speech reception thresholds."||||<0.05
91657676|NCT05150964|183208654|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The ASG setting will have no effect on the speech reception threshold."||||>0.05
91657677|NCT05150964|183208655|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The ASG setting will have no effect on the Word Recognition Scores."||||<0.05
91657678|NCT05150964|183208655|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The presentation level will have no effect on the Word Recognition Scores."||||<0.05
91524439|NCT02799472|182923978|OTHER||Ratio|0.979||||0.78|TWO_SIDED|95.0|0.842|1.139|||Repeated measures analysis|||MMP-Degraded CRP, Week 6||1.139|0.842|0.780
91657679|NCT05150964|183208655|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: Hearing aid prescription will have no effect on the Word Recognition Scores."||||<0.05
91657680|NCT05150964|183208656|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on multi-word recognition scores."||||<0.05
91657681|NCT05150964|183208656|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on multi-word recognition scores."||||>0.05
91524440|NCT02799472|182923978|OTHER||Ratio|1.113||||0.212|TWO_SIDED|95.0|0.938|1.32|||Repeated measures analysis|||MMP-Degraded CRP, Week 8||1.320|0.938|0.212
91657682|NCT05150964|183208656|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on multi-word recognition scores."||||>0.05
91657683|NCT05150964|183208657|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Nonword Detection scores."||||<0.05
91657684|NCT05150964|183208657|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on Nonword Detection scores."||||<0.05
91524441|NCT02799472|182923978|OTHER||Ratio|1.102||||0.242|TWO_SIDED|95.0|0.934|1.3|||Repeated measures analysis|||MMP-Degraded CRP, Week 12||1.300|0.934|0.242
91618082|NCT01000727|183129258|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.631|TWO_SIDED|95.0|0.86|1.09|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.09|0.86|0.631
91657685|NCT05150964|183208657|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Nonword Detection scores."||||>0.05
91657686|NCT05150964|183208658|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Rapid Word Learning scores."||||>0.05
91657687|NCT05150964|183208658|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Rapid Word Learning scores."||||>0.05
91657688|NCT05150964|183208658|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescripton will have no effect on Rapid Word Learning scores."||||>0.05
91657689|NCT01062256|183208674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.216|TWO_SIDED|95.0|0.64|1.1||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.10|0.64|0.216
91712849|NCT03570047|183317482|OTHER||Hazard Ratio (HR)|0.71||||0.0001|TWO_SIDED|95.0|0.592|0.842|||Cox proportional hazards model|||||0.842|0.592|0.0001
91712850|NCT03570047|183317482|OTHER||Hazard Ratio (HR)|0.72||||0.0012|TWO_SIDED|95.0|0.591|0.879|||Cox proportional hazards model|||||0.879|0.591|0.0012
91524442|NCT02799472|182923978|OTHER||Ratio|1.05||||0.597|TWO_SIDED|95.0|0.87|1.267|||Repeated measures analysis|||MMP-Degraded CRP, 12-Week FU||1.267|0.870|0.597
91524443|NCT02799472|182923978|OTHER||Ratio|0.795||||0.047|TWO_SIDED|95.0|0.634|0.997|||Repeated measures analysis|||MD1C, Week 1||0.997|0.634|0.047
91618083|NCT01000727|183129259|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.354|TWO_SIDED|95.0|0.88|1.42|||Cox Proportional Hazard Regression Model||A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo|||1.42|0.88|0.354
91618084|NCT01000727|183129260|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.161|TWO_SIDED|95.0|0.73|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.73|0.161
91618085|NCT01000727|183129261|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.36|TWO_SIDED|95.0|0.91|1.31|||Cox Proportional Hazard Regression Model|||||1.31|0.91|0.360
91618086|NCT01000727|183129262|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.202|TWO_SIDED|95.0|0.88|1.03|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.03|0.88|0.202
91618087|NCT01000727|183129263|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.329|TWO_SIDED|95.0|0.87|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.87|0.329
91618088|NCT01000727|183129264|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.797|TWO_SIDED|95.0|0.9|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.90|0.797
91618089|NCT01000727|183129265|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.546|TWO_SIDED|95.0|0.87|1.07|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.07|0.87|0.546
91618090|NCT01000727|183129266|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.362|TWO_SIDED|95.0|0.81|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.81|0.362
91618091|NCT02059213|183129294|SUPERIORITY|||||||0.87|||||||Fisher Exact|Mid P-value||With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.||||0.87
91657690|NCT01062256|183208674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.513|TWO_SIDED|95.0|0.72|1.18||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.18|0.72|0.513
91657691|NCT01062256|183208674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.459|TWO_SIDED|95.0|0.87|1.38||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.38|0.87|0.459
91657692|NCT01062256|183208675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.195|TWO_SIDED|95.0|0.65|1.09||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.09|0.65|0.195
91657693|NCT01062256|183208675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.438|TWO_SIDED|95.0|0.71|1.16||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.16|0.71|0.438
91657694|NCT01062256|183208675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.497|TWO_SIDED|95.0|0.87|1.34||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.34|0.87|0.497
91657695|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.25|TWO_SIDED|95.0|0.64|1.12||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.12|0.64|0.250
91524444|NCT02799472|182923978|OTHER||Ratio|0.883||||0.367|TWO_SIDED|95.0|0.668|1.165|||Repeated measures analysis|||MD1C, Week 2||1.165|0.668|0.367
91657696|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.802|TWO_SIDED|95.0|0.75|1.25||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.25|0.75|0.802
91657697|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.188|TWO_SIDED|95.0|0.94|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.39|0.94|0.188
91524445|NCT02799472|182923978|OTHER||Ratio|0.784||||0.155|TWO_SIDED|95.0|0.558|1.102|||Repeated measures analysis|||MD1C, Week 4||1.102|0.558|0.155
91524446|NCT02799472|182923978|OTHER||Ratio|0.638||||0.004|TWO_SIDED|95.0|0.477|0.855|||Repeated measures analysis|||MD1C, Week 6||0.855|0.477|0.004
91618092|NCT02059213|183129296|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||||||0.92
91618093|NCT02059213|183129297|SUPERIORITY|||||||0.5|||||||Fisher Exact|Mid p-value||||||0.50
91618094|NCT02059213|183129298|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
91618095|NCT02059213|183129299|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
91618096|NCT03583372|183129303|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.4|||||TWO_SIDED|95.0|-2.9|-2.0||||||||-2.0|-2.9|
91618097|NCT03583372|183129303|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.0|||||TWO_SIDED|95.0|-2.5|-1.5||||||||-1.5|-2.5|
91618098|NCT03583372|183129304|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.2|||||TWO_SIDED|95.0|-2.5|-1.9||||||||-1.9|-2.5|
91618099|NCT03583372|183129304|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.7|||||TWO_SIDED|95.0|-2.0|-1.3||||||||-1.3|-2.0|
91618100|NCT03583372|183129305|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.4|||||TWO_SIDED|95.0|-4.0|-2.7||||||||-2.7|-4.0|
91618101|NCT03583372|183129305|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.2|||||TWO_SIDED|95.0|-4.0|-2.5||||||||-2.5|-4.0|
91618102|NCT03583372|183129306|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.5|||||TWO_SIDED|95.0|-2.8|-2.2||||||||-2.2|-2.8|
91618103|NCT03583372|183129306|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.9|||||TWO_SIDED|95.0|-2.3|-1.6||||||||-1.6|-2.3|
91618104|NCT03446651|183129327|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
91618105|NCT03446651|183129329|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
91618106|NCT03446651|183129331|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91618107|NCT03446651|183129332|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91712851|NCT03570047|183317483|OTHER||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.614|0.843|||Cox proportional hazards model|||||0.843|0.614|<0.0001
91712852|NCT03570047|183317483|OTHER||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.529|0.825|||Cox proportional hazards model|||||0.825|0.529|0.0003
91657698|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.58|1.04||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.04|0.58|0.091
91657699|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.465|TWO_SIDED|95.0|0.69|1.19||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.19|0.69|0.465
91657700|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.207|TWO_SIDED|95.0|0.92|1.46||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.46|0.92|0.207
91657701|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.122|TWO_SIDED|95.0|0.62|1.06||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.06|0.62|0.122
91657702|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.165|TWO_SIDED|95.0|0.66|1.07||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.07|0.66|0.165
91657703|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.711|TWO_SIDED|95.0|0.83|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.32|0.83|0.711
91657704|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.215|TWO_SIDED|95.0|0.64|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.11|0.64|0.215
91712853|NCT03570047|183317483|OTHER||Hazard Ratio (HR)|0.74||||0.0007|TWO_SIDED|95.0|0.618|0.879|||Cox proportional hazards model|||||0.879|0.618|0.0007
91712854|NCT03570047|183317483|OTHER||Hazard Ratio (HR)|0.71||||0.0011|TWO_SIDED|95.0|0.583|0.874|||Cox proportional hazards model|||||0.874|0.583|0.0011
91657705|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.367|TWO_SIDED|95.0|0.67|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.16|0.67|0.367
91657706|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.687|TWO_SIDED|95.0|0.82|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.35|0.82|0.687
91712855|NCT03570047|183317484|OTHER||Hazard Ratio (HR)|0.93||||0.0127|TWO_SIDED|95.0|0.872|0.984|||Cox proportional hazards model|||||0.984|0.872|0.0127
91712856|NCT03570047|183317484|OTHER||Hazard Ratio (HR)|0.96||||0.2893||95.0|0.881|1.039|||Cox proportional hazards model|||||1.039|0.881|0.2893
91712857|NCT03570047|183317484|OTHER||Hazard Ratio (HR)|0.94||||0.064|TWO_SIDED|95.0|0.881|1.004|||Cox proportional hazards model|||||1.004|0.881|0.0640
91712858|NCT03570047|183317484|OTHER||Hazard Ratio (HR)|1.03||||0.4404|TWO_SIDED|95.0|0.958|1.103|||Cox proportional hazards model|||||1.103|0.958|0.4404
91712859|NCT01765296|183317500|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.011|||||||ANCOVA|||The primary efficacy outcome measure is the change in the WOMAC-Pain Subscale in the index joint at Week 6 vs. pre-dose Baseline and was analyzed using a mixed effect ANCOVA. Statistical tests to determine superiority between two treatment arms, CG100649 2 mg and placebo, are two-sided, and Non-inferiority between two treatment arms, CG100649 2 mg and celecoxib 200 mg is based on a one-sided 97.5% confidence interval of the difference.||||0.011
91657707|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.73|TWO_SIDED|95.0|0.67|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.32|0.67|0.730
91657708|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.923|TWO_SIDED|95.0|0.74|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.39|0.74|0.923
91657709|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.573|TWO_SIDED|95.0|0.83|1.4||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.40|0.83|0.573
91657710|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.289|TWO_SIDED|95.0|0.61|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.16|0.61|0.289
91657711|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.379|TWO_SIDED|95.0|0.64|1.18||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.18|0.64|0.379
91657712|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.785|TWO_SIDED|95.0|0.79|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.37|0.79|0.785
91657713|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.194|TWO_SIDED|95.0|0.6|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.60|0.194
91657714|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.212|TWO_SIDED|95.0|0.62|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.62|0.212
91657715|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.77|1.34||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.34|0.77|0.901
91657716|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6|TWO_SIDED|95.0|0.7|1.23||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.23|0.70|0.600
91657717|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.853|TWO_SIDED|95.0|0.74|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.29|0.74|0.853
91657718|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.736|TWO_SIDED|95.0|0.79|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.39|0.79|0.736
91657719|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.744|TWO_SIDED|95.0|0.7|1.3||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.30|0.70|0.744
91657720|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.904|TWO_SIDED|95.0|0.72|1.33||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.33|0.72|0.904
91657721|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.828|TWO_SIDED|95.0|0.77|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.39|0.77|0.828
91657722|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.147|TWO_SIDED|95.0|0.59|1.08||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.08|0.59|0.147
91657723|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.345|TWO_SIDED|95.0|0.65|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.16|0.65|0.345
91657724|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.532|TWO_SIDED|95.0|0.83|1.44||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.44|0.83|0.532
91657725|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.261|TWO_SIDED|95.0|0.61|1.15||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.15|0.61|0.261
91657726|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.601|TWO_SIDED|95.0|0.69|1.24||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.24|0.69|0.601
91657727|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.47|TWO_SIDED|95.0|0.84|1.47||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.47|0.84|0.470
91657728|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.834|TWO_SIDED|95.0|0.71|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.32|0.71|0.834
91657729|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.628|TWO_SIDED|95.0|0.81|1.43||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.43|0.81|0.628
91657730|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.481|TWO_SIDED|95.0|0.83|1.48||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.48|0.83|0.481
91657731|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.749|TWO_SIDED|95.0|0.65|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.37|0.65|0.749
91657732|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.857|TWO_SIDED|95.0|0.7|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.35|0.70|0.857
91657733|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.847|TWO_SIDED|95.0|0.76|1.41||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.41|0.76|0.847
91657734|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.146|TWO_SIDED|95.0|0.54|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.09|0.54|0.146
91657735|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.702|TWO_SIDED|95.0|0.69|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.29|0.69|0.702
91657736|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.228|TWO_SIDED|95.0|0.88|1.69||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.69|0.88|0.228
91657737|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.13|TWO_SIDED|95.0|0.51|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.09|0.51|0.130
91657738|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.371|TWO_SIDED|95.0|0.6|1.21||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.21|0.60|0.371
91657739|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.43|TWO_SIDED|95.0|0.82|1.58||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.58|0.82|0.430
91657740|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.51|1.13||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.13|0.51|0.177
91657741|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.28||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.28|0.64|0.580
91657742|NCT01062256|183208676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.333|TWO_SIDED|95.0|0.84|1.7||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.70|0.84|0.333
91657743|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.264|TWO_SIDED|95.0|-0.08|0.27||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.27|-0.08|0.264
91657744|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.737|TWO_SIDED|95.0|-0.2|0.14||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.14|-0.20|0.737
91657745|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.078|TWO_SIDED|95.0|-0.27|0.01||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.01|-0.27|0.078
91657746|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.125|TWO_SIDED|95.0|-0.04|0.36||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.36|-0.04|0.125
91657747|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.688|TWO_SIDED|95.0|-0.16|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.24|-0.16|0.688
91657748|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.166|TWO_SIDED|95.0|-0.29|0.05||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.05|-0.29|0.166
91657749|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.233|TWO_SIDED|95.0|-0.09|0.35||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.35|-0.09|0.233
91657750|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.848|TWO_SIDED|95.0|-0.24|0.19||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.19|-0.24|0.848
91657751|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.093|TWO_SIDED|95.0|-0.33|0.03||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.03|-0.33|0.093
91657752|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.406|TWO_SIDED|95.0|-0.14|0.34||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.34|-0.14|0.406
91657753|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.24|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.24|-0.24|0.991
91657754|NCT01062256|183208677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.306|TWO_SIDED|95.0|-0.3|0.09||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.09|-0.30|0.306
91657755|NCT01062256|183208678|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma statistic|0.15||||0.254|TWO_SIDED|95.0|-0.09|0.39||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.39|-0.09|0.254
91657756|NCT01062256|183208678|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.01||||0.949|TWO_SIDED|95.0|-0.25|0.23||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.23|-0.25|0.949
91657757|NCT01062256|183208678|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.12||||0.256|TWO_SIDED|95.0|-0.32|0.08||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.08|-0.32|0.256
91657758|NCT03561883|183208701|SUPERIORITY||Least squares (LS) mean difference|-0.062||||0.5566|TWO_SIDED|95.0|-0.27|0.146|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.146|-0.270|0.5566
91657759|NCT03561883|183208702|SUPERIORITY||LS mean difference|-0.008||||0.9226|TWO_SIDED|95.0|-0.176|0.159|||MMRM|||Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.159|-0.176|0.9226
91657760|NCT03561883|183208703|SUPERIORITY||Difference in Responder Rate|1.3|||||TWO_SIDED|95.0|-6.9|9.5|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||9.5|-6.9|
91657761|NCT03561883|183208703|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7424|TWO_SIDED|95.0|0.76|1.48|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.48|0.76|0.7424
91657762|NCT03561883|183208704|SUPERIORITY||Difference in Proportion Ratio|1.171||||0.4164|TWO_SIDED|95.0|0.8|1.714||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.714|0.800|0.4164
91657763|NCT03561883|183208704|OTHER|Negative binomial model was used to deal with data overdispersion|Difference in Proportion Ratio|0.034|||||TWO_SIDED|95.0|-0.054|0.123|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.123|-0.054|
91657764|NCT03006978|183208731|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
91657765|NCT03006978|183208732|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
91657766|NCT03006978|183208733|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
91657767|NCT03006978|183208734|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
91657768|NCT03006978|183208735|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
91657769|NCT01395030|183208743|OTHER||||||||||||||||||"Analysis was performed using Gene Set Enrichment Analysis (GSEA version 19.0.24, Broad Institute, Cambridge, MA) implemented in GenePattern (Broad Institute, Cambridge, MA) by uploading expression array data to this cloud-computing genomics platform. The specific details of this statistical approach can be found in the following publicly available references:~Reich M, Liefeld T, Gould J, Lerner J, Tamayo P, Mesirov JP. GenePattern 2.0 Nature Genetics 38 no. 5 (2006): pp500-501~Subramanian A, Tamayo P, Mootha VK, Mukherjee S, Ebert BL, Gillette MA, Paulovich A, Pomeroy SL, Golub TR, Lander ES, Mesirov JP. Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles. PNAS. 2005;102(43);15545-15550."|||
91657770|NCT01054599|183208812|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91657771|NCT01054599|183208815|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||||||>0.05
91657772|NCT00705536|183208871|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0006
91657773|NCT00705536|183208871|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
91657774|NCT00705536|183208872|SUPERIORITY_OR_OTHER|||||||0.0003||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0003
91657775|NCT00705536|183208872|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
91657776|NCT00705536|183208873|SUPERIORITY_OR_OTHER|||||||0.0059||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0059
91657777|NCT00705536|183208873|SUPERIORITY_OR_OTHER|||||||0.0105||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0105
91657778|NCT00705536|183208874|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
91657779|NCT00705536|183208874|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
91657780|NCT00705536|183208875|SUPERIORITY_OR_OTHER|||||||0.3019||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.3019
91657781|NCT00705536|183208876|SUPERIORITY_OR_OTHER|||||||0.0401||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0401
91657782|NCT00705536|183208876|SUPERIORITY_OR_OTHER|||||||0.0004||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0004
91657783|NCT00705536|183208877|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog +rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
91657784|NCT00705536|183208877|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
91657785|NCT00705536|183208879|SUPERIORITY_OR_OTHER|||||||0.5589||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.5589
91657786|NCT00705536|183208879|SUPERIORITY_OR_OTHER|||||||0.0067||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0067
91657787|NCT02289963|183208890|SUPERIORITY||Least Square (LS) Mean Difference|-63.4|||<|0.0001|TWO_SIDED|95.0|-71.6|-55.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-55.2|-71.6|<0.0001
91657788|NCT02289963|183208891|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|95.0|-73.9|-58.4||Threshold for significance was at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-58.4|-73.9|<0.0001
91657789|NCT02289963|183208892|SUPERIORITY||LS Mean Difference|-62.5|||<|0.0001|TWO_SIDED|95.0|-68.8|-56.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.3|-68.8|<0.0001
91657790|NCT02289963|183208893|SUPERIORITY||LS Mean Difference|-63.1|||<|0.0001|TWO_SIDED|95.0|-69.2|-57.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.0|-69.2|<0.0001
91657791|NCT02289963|183208894|SUPERIORITY||LS Mean Difference|-46.3|||<|0.0001|TWO_SIDED|95.0|-53.0|-39.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.7|-53.0|<0.0001
91657792|NCT02289963|183208895|SUPERIORITY||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.1|-55.3|<0.0001
91657793|NCT02289963|183208896|SUPERIORITY||LS Mean Difference|-51.5|||<|0.0001|TWO_SIDED|95.0|-58.4|-44.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-58.4|<0.0001
91657794|NCT02289963|183208897|SUPERIORITY||LS Mean Difference|-54.2|||<|0.0001|TWO_SIDED|95.0|-60.6|-47.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-60.6|<0.0001
91657795|NCT02289963|183208898|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-40.3|-30.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.1|-40.3|<0.0001
91657796|NCT02289963|183208899|SUPERIORITY||LS Mean Difference|-46.1|||<|0.0001|TWO_SIDED|95.0|-51.2|-41.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.0|-51.2|<0.0001
91657797|NCT02289963|183208900|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-56.4|-46.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.1|-56.4|<0.0001
91657798|NCT02289963|183208901|SUPERIORITY||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-39.7|-31.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant.||-31.9|-39.7|<0.0001
91657799|NCT02289963|183208902|SUPERIORITY||Odds Ratio (OR)|46.9|||<|0.0001|TWO_SIDED|95.0|18.4|119.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||119.4|18.4|<0.0001
91657800|NCT02289963|183208903|SUPERIORITY||Odds Ratio (OR)|70.0|||<|0.0001|TWO_SIDED|95.0|23.3|210.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||210.8|23.3|<0.0001
91657801|NCT02289963|183208904|SUPERIORITY||Adjusted Mean Difference|-33.611|||<|0.0001|TWO_SIDED|95.0|-41.883|-25.338||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.338|-41.883|<0.0001
91657802|NCT02289963|183208905|SUPERIORITY||LS Mean Difference|7.5||||0.0029|TWO_SIDED|95.0|2.6|12.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.4|2.6|0.0029
91657803|NCT02289963|183208906|SUPERIORITY||LS Mean Difference|-4.515||||0.311|TWO_SIDED|95.0|-13.25|4.219||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.219|-13.250|0.3110
91657804|NCT00840632|183209012|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|93.26||||||90.0|83.39|104.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.31|83.39|
91657805|NCT00840632|183209013|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.35||||||90.0|92.08|109.36|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.36|92.08|
91657806|NCT00840632|183209014|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.17||||||90.0|92.71|106.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.08|92.71|
91657807|NCT00840632|183209015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|102.93||||||90.0|99.8|106.15|||||Informational Purposes Only|||106.15|99.80|
91657808|NCT00840632|183209016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.24||||||90.0|98.11|102.43|||||Informational Purposes Only|||102.43|98.11|
91657809|NCT00840632|183209017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.1||||||90.0|98.12|102.12|||||Informational Purposes Only|||102.12|98.12|
91657810|NCT05628675|183209049|OTHER||Effect size (Hedge's g)|0.32|||||TWO_SIDED|95.0|-0.33|0.96||||||Effect size calculation from Time 1 to Time 2 on MAAS||0.96|-0.33|
91657811|NCT05628675|183209049|OTHER||Effect size (Hedge's g)|0.72|||||TWO_SIDED|95.0|0.02|1.42||||||Effect size calculation from Time 1 to Time 3 on MAAS||1.42|0.02|
91657812|NCT05628675|183209050|OTHER||Effect size (Hedge's g)|0.36|||||TWO_SIDED|95.0|-0.29|1.01||||||Effect size calculation from Time 1 to Time 2 on P-PRFQ||1.01|-0.29|
91657813|NCT05628675|183209050|OTHER||Effect size (Hedge's g)|0.49|||||TWO_SIDED|95.0|-0.2|1.17||||||Effect size calculation from Time 1 to Time 3 on P-PRFQ||1.17|-0.20|
91657814|NCT05628675|183209051|OTHER||Effect size (Hedge's g)|1.48|||||TWO_SIDED|95.0|0.75|2.21||||||Effect size calculation from Time 1 to Time 2 on EPDS||2.21|0.75|
91657815|NCT05628675|183209051|OTHER||Effect size (Hedge's g)|2.08|||||TWO_SIDED|95.0|1.28|2.88||||||Effect size calculation from Time 1 to Time 3 on EPDS||2.88|1.28|
91657816|NCT02028715|183209067|SUPERIORITY||Mean Difference (Final Values)|5.55501|STANDARD_ERROR_OF_MEAN|5.96535||0.356|TWO_SIDED|95.0|-6.3904|17.50042|||t-test for Equality of Means|||||17.50042|-6.39040|.356
91657817|NCT02028715|183209068|SUPERIORITY||Median Difference (Final Values)|11.51818|STANDARD_ERROR_OF_MEAN|6.98569||0.105|TWO_SIDED|95.0|-2.49963|25.53599|||t-test for Equality of Means|||||25.53599|-2.49963|.105
91657818|NCT02028715|183209069|SUPERIORITY|||||||0.029|||||||ANOVA|||||||.029
91657819|NCT02028715|183209070|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.643|||||||ANOVA|||||||.643
91657820|NCT02028715|183209071|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.217|||||||ANOVA|||||||.217
91657821|NCT02028715|183209072|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.647|||||||ANOVA|||||||.647
91657822|NCT02028715|183209073|SUPERIORITY||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.587|0.695||||||||.695|-.587|
91791522|NCT01143701|183460858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|||<|0.05|TWO_SIDED|95.0|-4.71|1.75|||Mixed Models Analysis|||An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||1.75|-4.71|<0.05
91657823|NCT01492361|183209074|SUPERIORITY||Hazard Ratio (HR)|0.75||||1e-08|TWO_SIDED|95.0|0.68|0.83||The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O'Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region||||0.83|0.68|0.00000001
91618108|NCT00960934|183129355|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.56||||0.749|TWO_SIDED|95.0|-1.04|2.16||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.16|-1.04|0.749
91618109|NCT00960934|183129355|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.12||||0.333|TWO_SIDED|95.0|-0.6|2.83||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.83|-0.60|0.333
91618110|NCT00960934|183129355|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.35||||0.823|TWO_SIDED|95.0|-1.14|1.84||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.84|-1.14|0.823
91618111|NCT00960934|183129355|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.93||||0.457|TWO_SIDED|95.0|-0.75|2.61||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.61|-0.75|0.457
91618112|NCT00960934|183129355|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.823|TWO_SIDED|95.0|-1.17|1.5||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.50|-1.17|0.823
91618113|NCT00960934|183129356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.8|||<|0.001||95.0|56.5|80.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||80.0|56.5|<0.001
91618114|NCT00960934|183129356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.1|||<|0.001|TWO_SIDED|95.0|39.6|65.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||65.2|39.6|<0.001
91618115|NCT00960934|183129356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|17.6|42.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.4|17.6|<0.001
91618116|NCT00960934|183129356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.1|||<|0.001|TWO_SIDED|95.0|17.0|42.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.0|17.0|<0.001
91657824|NCT01492361|183209075|SUPERIORITY||Hazard Ratio (HR)|0.74||||6e-07|TWO_SIDED|95.0|0.65|0.83||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.83|0.65|0.0000006
91618117|NCT00960934|183129356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.254|TWO_SIDED|95.0|-4.1|14.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||14.4|-4.1|0.254
91618118|NCT00960934|183129357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.6|||<|0.001|TWO_SIDED|95.0|34.9|60.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||60.0|34.9|<0.001
91618119|NCT00960934|183129357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.9|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||48.5|24.1|<0.001
91618120|NCT00960934|183129357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2||||0.001|TWO_SIDED|95.0|7.7|28.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||28.7|7.7|0.001
91618121|NCT00960934|183129357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||18.2|-0.0|0.050
91618122|NCT00960934|183129357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.313|TWO_SIDED|95.0|-8.5|4.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||4.2|-8.5|0.313
91618123|NCT00960934|183129358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.8|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.8|-5.8|>0.999
91618124|NCT00960934|183129358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
91618125|NCT00960934|183129358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
91618126|NCT00960934|183129358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.313|TWO_SIDED|95.0|-4.2|8.6|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.6|-4.2|0.313
91618127|NCT00960934|183129358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.321|TWO_SIDED|95.0|-4.3|8.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.4|-4.3|0.321
91618128|NCT00960934|183129360|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-1.03|1.51||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.51|-1.03|0.959
91657825|NCT01492361|183209076|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.0|0.66|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.66|<0.0001
91657826|NCT01492361|183209077|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.81||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.81|0.58|<0.0001
91618129|NCT00960934|183129360|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.02||||0.971|TWO_SIDED|95.0|-1.08|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.08|0.971
91618130|NCT00960934|183129360|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-0.95|1.42||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.42|-0.95|0.959
91618131|NCT00960934|183129360|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.41||||0.915|TWO_SIDED|95.0|-1.78|0.97||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.97|-1.78|0.915
91618132|NCT00960934|183129360|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.959|TWO_SIDED|95.0|-1.6|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.60|0.959
91618133|NCT00960934|183129361|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.58||||0.849|TWO_SIDED|95.0|-1.22|2.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.37|-1.22|0.849
91618134|NCT00960934|183129361|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.16||||0.964|TWO_SIDED|95.0|-1.79|1.47||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.47|-1.79|0.964
91618135|NCT00960934|183129361|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.964|TWO_SIDED|95.0|-1.27|1.59||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.59|-1.27|0.964
91618136|NCT00960934|183129361|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.48||||0.855|TWO_SIDED|95.0|-2.23|1.27||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.27|-2.23|0.855
91618137|NCT00960934|183129361|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.27||||0.287|TWO_SIDED|95.0|-0.58|3.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.12|-0.58|0.287
91618138|NCT00960934|183129362|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.6||||0.933|TWO_SIDED|95.0|-1.56|2.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.77|-1.56|0.933
91618139|NCT00960934|183129362|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.01||||0.999|TWO_SIDED|95.0|-1.69|1.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.68|-1.69|0.999
91618140|NCT00960934|183129362|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.05||||0.999|TWO_SIDED|95.0|-1.84|1.93||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.93|-1.84|0.999
91618141|NCT00960934|183129362|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.45||||0.959|TWO_SIDED|95.0|-1.67|2.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.57|-1.67|0.959
91618142|NCT00960934|183129362|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.08||||0.999|TWO_SIDED|95.0|-2.1|1.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.94|-2.10|0.999
91657827|NCT01492361|183209078|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.78||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.78|0.55|<0.0001
91791523|NCT01402427|183460861|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.28|TWO_SIDED|95.0|-0.011|0.033|||Fisher Exact|||||0.033|-0.011|0.28
91791524|NCT01402427|183460862|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
91791525|NCT01402427|183460863|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91791526|NCT01402427|183460864|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91791527|NCT01402427|183460865|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
91791528|NCT01402427|183460866|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91791529|NCT01402427|183460867|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
91791530|NCT01634191|183460879|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.2|135.0|||||Geometric mean ratio (Elderly/Young) and 90% confidence interval (CI) of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.2|
91791531|NCT01634191|183460881|OTHER||Geometric Mean Ratio|128.0|||||TWO_SIDED|90.0|107.0|154.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||154|107|
91657828|NCT01492361|183209079|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0315|TWO_SIDED|95.0|0.66|0.98||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.98|0.66|0.0315
91657829|NCT01492361|183209080|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0018|TWO_SIDED|95.0|0.53|0.87||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.87|0.53|0.0018
91657830|NCT01492361|183209081|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0129|TWO_SIDED|95.0|0.55|0.93||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.93|0.55|0.0129
91657831|NCT01492361|183209082|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.69|<0.0001
91657832|NCT01492361|183209083|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0915|TWO_SIDED|95.0|0.74|1.02||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||1.02|0.74|0.0915
91657833|NCT01475838|183209084|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.|Difference in proportions|6.7||||0.025|TWO_SIDED|95.0|0.4|13.7|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||13.7|0.4|0.025
91657834|NCT03227445|183209121|SUPERIORITY||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|1.97|54.28|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||"There are three intercurrent events identified which could impact upon the estimand of interest:~* The participant could withdraw from randomised study device sequence and therefore withdraw from the study~* The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol.~* The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol.~Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events"|54.28|1.97|<0.001
91657835|NCT03227445|183209123|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
91657836|NCT03227445|183209128|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.001|TWO_SIDED|95.0|3.45||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||||3.45|<0.001
91657837|NCT03227445|183209129|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Estimand: Composite)||||||<0.001
91657838|NCT03227445|183209130|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
91657839|NCT03227445|183209131|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Composite Estimand)||||||<0.001
91657840|NCT03227445|183209132|SUPERIORITY||Odds Ratio (OR)|6.06|||<|0.001|TWO_SIDED|95.0|2.08|24.55|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.|||24.55|2.08|<0.001
91657841|NCT01629381|183209173|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.3|-0.4|||Fisher Exact|||||-0.4|-11.3|0.03
91657842|NCT01629381|183209175|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.7|-0.1|||Fisher Exact|||||-0.1|-11.7|0.03
91657843|NCT01629381|183209176|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.0||||0.53|TWO_SIDED|95.0|-8.0|3.7|||Fisher Exact|||||3.7|-8.0|0.53
91657844|NCT02158494|183209177|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 2 weeks||||0.41
91657845|NCT02158494|183209177|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 14 weeks||||0.47
91657846|NCT02158494|183209177|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 26 weeks||||0.99
91657847|NCT02545998|183209202|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.510
91657848|NCT02545998|183209203|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91657849|NCT02545998|183209204|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91657850|NCT02545998|183209205|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
91657851|NCT02545998|183209206|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
91657852|NCT02545998|183209207|SUPERIORITY|||||||0.264|||||||Sign test|||||||0.264
91657853|NCT04567342|183209230|SUPERIORITY||Risk Ratio (RR)|1.08||||0.531|TWO_SIDED|95.0|0.85|1.37|||Regression, Logistic||||Arm 3 vs. Arm 1|1.37|0.85|0.531
91657854|NCT04567342|183209230|SUPERIORITY||Risk Ratio (RR)|0.84||||0.189|TWO_SIDED|95.0|0.65|1.09|||Regression, Logistic||||Arm 2 vs. Arm 1|1.09|0.65|0.189
91657855|NCT04567342|183209230|SUPERIORITY||Risk Ratio (RR)|1.29||||0.054|TWO_SIDED|95.0|0.1|1.66|||Regression, Logistic||||Arm 3 vs. Arm 2|1.66|0.10|0.054
91712860|NCT01765296|183317500|NON_INFERIORITY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.425|||||||ANCOVA|||||||0.425
91657856|NCT04567342|183209230|SUPERIORITY||Risk Ratio (RR)|1.05||||0.654|TWO_SIDED|95.0|0.84|1.32|||Regression, Logistic||||Arm 4 vs. Arm 3|1.32|0.84|0.654
91657857|NCT04567342|183209230|SUPERIORITY||Risk Ratio (RR)|1.36||||0.018|TWO_SIDED|95.0|1.05|1.74|||Regression, Logistic||||Arm 4 vs. Arm 2|1.74|1.05|0.018
91657858|NCT04567342|183209230|SUPERIORITY||Risk Ratio (RR)|1.14||||0.283|TWO_SIDED|95.0|0.9|1.44|||Regression, Logistic||||Arm 4 vs. Arm 1|1.44|0.90|0.283
91657859|NCT04567342|183209231|SUPERIORITY||Risk Ratio (RR)|1.93|||<|0.01|TWO_SIDED|95.0|1.42|2.62|||Regression, Logistic||||Arm 3 vs. Arm 1|2.62|1.42|<0.01
91657860|NCT04567342|183209231|SUPERIORITY||Risk Ratio (RR)|0.82||||0.318|TWO_SIDED|95.0|0.56|1.21|||Regression, Logistic||||Arm 2 vs. Arm 1|1.21|0.56|0.318
91657861|NCT04567342|183209231|SUPERIORITY||Risk Ratio (RR)|2.34|||<|0.01|TWO_SIDED|95.0|1.68|3.26|||Regression, Logistic||||Arm 3 vs. Arm 2|3.26|1.68|<0.01
91657862|NCT04567342|183209231|SUPERIORITY||Risk Ratio (RR)|1.08||||0.535|TWO_SIDED|95.0|0.85|1.36|||Regression, Logistic||||Arm 4 vs. Arm 3|1.36|0.85|0.535
91657863|NCT04567342|183209231|SUPERIORITY||Risk Ratio (RR)|2.52|||<|0.01|TWO_SIDED|95.0|1.82|3.5|||Regression, Logistic||||Arm 4 vs Arm 2|3.50|1.82|<0.01
91657864|NCT04567342|183209231|SUPERIORITY||Risk Ratio (RR)|2.07|||<|0.01|TWO_SIDED|95.0|1.53|2.8|||Regression, Logistic||||Arm 4 vs. Arm 1|2.80|1.53|<0.01
91657865|NCT04567342|183209232|SUPERIORITY||Risk Ratio (RR)|1.17||||0.192|TWO_SIDED|95.0|0.92|1.48|||Regression, Logistic||||Arm 3 vs. Arm 1|1.48|0.92|0.192
91657866|NCT04567342|183209232|SUPERIORITY||Risk Ratio (RR)|0.81||||0.132|TWO_SIDED|95.0|0.62|1.06|||Regression, Logistic||||Arm 2 vs. Arm 1|1.06|0.62|0.132
91657867|NCT04567342|183209232|SUPERIORITY||Risk Ratio (RR)|1.44|||<|0.01|TWO_SIDED|95.0|1.11|1.86|||Regression, Logistic||||Arm 3 vs. Arm 2|1.86|1.11|<0.01
91524447|NCT02799472|182923978|OTHER||Ratio|0.799||||0.14|TWO_SIDED|95.0|0.591|1.08|||Repeated measures analysis|||MD1C, Week 8||1.080|0.591|0.140
91657868|NCT04567342|183209232|SUPERIORITY||Risk Ratio (RR)|0.92||||0.462|TWO_SIDED|95.0|0.73|1.16|||Regression, Logistic||||Arm 4 vs. Arm 3|1.16|0.73|0.462
91657869|NCT04567342|183209232|SUPERIORITY||Risk Ratio (RR)|1.32||||0.039|TWO_SIDED|95.0|1.01|1.72|||Regression, Logistic||||Arm 4 vs. Arm 2|1.72|1.01|0.039
91657870|NCT04567342|183209232|SUPERIORITY||Risk Ratio (RR)|1.07||||0.57|TWO_SIDED|95.0|0.84|1.37|||Regression, Logistic||||Arm 4 vs. Arm 1|1.37|0.84|0.570
91657871|NCT01226797|183209233|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5834||||0.6668|TWO_SIDED|95.0|0.1|3.51|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect|||3.51|0.10|0.6668
91657872|NCT01226797|183209234|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1591||||0.155|TWO_SIDED|95.0|0.01|1.73|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect.|||1.73|0.01|0.1550
91657873|NCT01226797|183209235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.45||||0.1259|TWO_SIDED|95.0|-7.79|58.69||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||58.69|-7.79|0.1259
91657874|NCT01226797|183209235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.49||||0.3297|TWO_SIDED|95.0|-14.67|41.66||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||41.66|-14.67|0.3297
91657875|NCT01226797|183209235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.17||||0.3925|TWO_SIDED|95.0|-21.04|51.39||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||51.39|-21.04|0.3925
91657876|NCT01226797|183209235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.62||||0.208|TWO_SIDED|95.0|-14.85|64.09||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||64.09|-14.85|0.2080
91657877|NCT01226797|183209237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.87||||0.0577|TWO_SIDED|95.0|-0.78|44.53||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||44.53|-0.78|0.0577
91712861|NCT03257436|183317502|OTHER|"A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:~* Performance goal = 90%~* Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%~* Significance level = 5%~* Power = 80%"|Kaplan Meir Methodology|99.0|||||ONE_SIDED|95.0|94.1|||||||"The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.~H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.~The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis."|||94.1|
91712862|NCT03257436|183317503|OTHER|Even though fewer subjects (78) were available for the effectiveness endpoint analysis than originally planned (110), the study was still powered at approximately 90%|Proportion|51.3|||||ONE_SIDED|95.0|41.1|||||||"The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.~H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%"|||41.1|
91712863|NCT01619852|183317504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
91657878|NCT01226797|183209237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3||||0.3669|TWO_SIDED|95.0|-11.71|30.3||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||30.30|-11.71|0.3669
91657879|NCT01226797|183209237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.09||||0.2482|TWO_SIDED|95.0|-10.62|38.8||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||38.80|-10.62|0.2482
91657880|NCT01226797|183209237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.19||||0.0801|TWO_SIDED|95.0|-3.84|62.22||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||62.22|-3.84|0.0801
91657881|NCT01226797|183209245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.06||||0.0031|TWO_SIDED|95.0|-35.67|-8.44||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||-8.44|-35.67|0.0031
91657882|NCT01226797|183209245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.34||||0.0015|TWO_SIDED|95.0|-25.64|-7.04||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||-7.04|-25.64|0.0015
91657883|NCT00577460|183209248|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX ER versus Placebo||||0.0039
91657884|NCT00577460|183209248|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX IR versus Placebo||||0.0001
91657885|NCT00577460|183209251|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5590
91657886|NCT00577460|183209251|SUPERIORITY_OR_OTHER|||||||0.1289||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1289
91657887|NCT00577460|183209253|SUPERIORITY_OR_OTHER|||||||0.1073||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1073
91657888|NCT00577460|183209253|SUPERIORITY_OR_OTHER|||||||0.8694||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8694
91712864|NCT01619852|183317505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91712865|NCT01619852|183317506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91657889|NCT00577460|183209254|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0009
91657890|NCT00577460|183209254|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0573
91657891|NCT00577460|183209255|SUPERIORITY_OR_OTHER|||||||0.6434||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.6434
91657892|NCT00577460|183209255|SUPERIORITY_OR_OTHER|||||||0.2469||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.2469
91657893|NCT00577460|183209256|SUPERIORITY_OR_OTHER|||||||0.9741||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.9741
91657894|NCT00577460|183209256|SUPERIORITY_OR_OTHER|||||||0.762||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.7620
91657895|NCT00577460|183209260|SUPERIORITY_OR_OTHER|||||||0.0831||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0831
91657896|NCT00577460|183209260|SUPERIORITY_OR_OTHER|||||||0.0759||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0759
91657897|NCT00577460|183209261|SUPERIORITY_OR_OTHER|||||||0.1713||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1713
91657898|NCT00577460|183209261|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0130
91657899|NCT00577460|183209262|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0015
91657900|NCT00577460|183209262|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0002
91657901|NCT00577460|183209263|SUPERIORITY_OR_OTHER|||||||0.876||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8760
91657902|NCT00577460|183209263|SUPERIORITY_OR_OTHER|||||||0.5113||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5113
91657903|NCT00577460|183209264|SUPERIORITY_OR_OTHER|||||||0.0148||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0148
91657904|NCT00577460|183209264|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0201
91657905|NCT02016170|183209284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined). Under the assumption of 0 difference in mean PRU between ticagrelor 90 mg bid MD and prasugrel 10 mg qd MD and a common standard deviation of 60 PRU, a sample size of 24 patients per group allowed for the 95% CI to stay within ± 45 PRU with a 90% power and alpha=0.05.|Mean Difference (Final Values)|-18.0|||||TWO_SIDED|95.0|-41.0|5.0||||||||5|-41|
91657906|NCT02016170|183209285|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined).|Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-18.0|-4.0||||||||-4|-18|
91657907|NCT01968382|183209314|SUPERIORITY|||||||0.3198|||||||ANOVA|||||||0.3198
91657908|NCT01968382|183209317|SUPERIORITY|||||||0.8462|||||||ANOVA|||||||0.8462
91657909|NCT03629249|183209369|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
91657910|NCT03629249|183209369|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||||||0.734
91657911|NCT03629249|183209370|SUPERIORITY|||||||0.665|||||||Wilcoxon (Mann-Whitney)|||||||0.665
91657912|NCT03629249|183209370|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
91657913|NCT03633721|183209390|SUPERIORITY|||||||0.17|||||||ANOVA|||Hypothesis Being Tested in 2 way ANOVA is that the difference in the change from Baseline to the Average of 15 and 60 minutes post baseline while on cannabis Vs. the change while on placebo (i.e. the last row in the outcomes) is greater for HIV+ subjects than for HIV- subjects.||||0.17
91657914|NCT03633721|183209391|SUPERIORITY|||||||0.18|||||||ANOVA|||Hypothesis Being Tested in 2 way ANOVA is that the difference in the change from Baseline to the Average of 15 and 60 minutes post baseline while on cannabis Vs. the change while on placebo (i.e. the last row in the outcomes) is greater for HIV+ subjects than for HIV- subjects.||||0.18
91657915|NCT03633721|183209392|SUPERIORITY|||||||0.72|||||||ANOVA|||Hypothesis Being Tested in 2 way ANOVA is that the difference in the change from Baseline to the Average of 15 and 60 minutes post baseline while on cannabis Vs. the change while on placebo (i.e. the last row in the outcomes) is greater for HIV+ subjects than for HIV- subjects.||||0.72
91657916|NCT01475474|183209397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero||||<0.001
91657917|NCT01475474|183209398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score||||<0.001
91657918|NCT01691248|183209425|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.2778|TWO_SIDED|95.0|-5.1|9.5||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.5|-5.1|0.2778
91657919|NCT01691248|183209426|SUPERIORITY_OR_OTHER||Percentage difference|0.6||||0.442|TWO_SIDED|95.0|-7.1|8.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||8.2|-7.1|0.4420
91618143|NCT00960934|183129363|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.17||||0.976|TWO_SIDED|95.0|-1.12|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.12|0.976
91712866|NCT01619852|183317506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-Sensory-discriminative dimension||||0.69
91618144|NCT00960934|183129363|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.06||||0.982|TWO_SIDED|95.0|-0.93|0.8||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.80|-0.93|0.982
91618145|NCT00960934|183129363|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.53||||0.489|TWO_SIDED|95.0|-0.43|1.49||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.49|-0.43|0.489
91618146|NCT00960934|183129363|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.02||||0.982|TWO_SIDED|95.0|-0.75|0.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.78|-0.75|0.982
91618147|NCT00960934|183129363|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.976|TWO_SIDED|95.0|-0.76|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-0.76|0.976
91618148|NCT00960934|183129364|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.35||||0.961|TWO_SIDED|95.0|-2.0|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-2.00|0.961
91618149|NCT00960934|183129364|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.961|TWO_SIDED|95.0|-1.9|1.34||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.34|-1.90|0.961
91618150|NCT00960934|183129364|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.66||||0.778|TWO_SIDED|95.0|-1.01|2.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.33|-1.01|0.778
91618151|NCT00960934|183129364|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.11||||0.961|TWO_SIDED|95.0|-1.45|1.24||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.24|-1.45|0.961
91618152|NCT00960934|183129364|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.25||||0.961|TWO_SIDED|95.0|-1.77|1.26||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.26|-1.77|0.961
91618153|NCT00960934|183129365|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.43||||0.901|TWO_SIDED|95.0|-2.03|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.03|0.901
91618154|NCT00960934|183129365|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.51||||0.901|TWO_SIDED|95.0|-2.18|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.18|0.901
91618155|NCT00960934|183129365|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.52||||0.901|TWO_SIDED|95.0|-2.17|1.13||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.13|-2.17|0.901
91618156|NCT00960934|183129365|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.03||||0.997|TWO_SIDED|95.0|-1.29|1.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.35|-1.29|0.997
91618157|NCT00960934|183129365|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.04||||0.997|TWO_SIDED|95.0|-1.51|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-1.51|0.997
91712867|NCT01619852|183317506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-affective dimension||||0.75
91712868|NCT01619852|183317506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Brief Pain Inventory||||0.81
91712869|NCT01619852|183317507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
91712870|NCT01619852|183317508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
91712871|NCT03877744|183317516|NON_INFERIORITY|Non-inferiority margin of 2.5 was set prior to study initiation with a Type I error of 0.025.|Mean Difference (Final Values)|1.6873|STANDARD_ERROR_OF_MEAN|0.2558||0.0008|ONE_SIDED|97.5||2.1894|||Mixed Models Analysis|Controls technician,site,seat type;Techn. nested in site modeled as random effect;Model allowed heterogeneous variances across arms w Kenward-Roger df|Mixed model allowed the arms to have unequal variance estimates. Degrees of freedom estimated using Kenward-Rogers.|||2.1894||0.0008
91712872|NCT00327717|183317529|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|||||||0.028
91712873|NCT00327717|183317530|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||ANOVA|||||||0.253
91712874|NCT00327717|183317531|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||ANOVA|||||||0.211
91712875|NCT00327717|183317532|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|||||||0.516
91712876|NCT00327717|183317533|SUPERIORITY_OR_OTHER|||||||0.044|||||||X^2 test|||||||0.044
91618158|NCT00960934|183129366|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.37||||0.979|TWO_SIDED|95.0|-2.73|1.99||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.99|-2.73|0.979
91618159|NCT00960934|183129366|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.92||||0.363|TWO_SIDED|95.0|-1.1|4.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||4.95|-1.10|0.363
91712877|NCT00327717|183317534|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
91712878|NCT00327717|183317535|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
91712879|NCT00327717|183317536|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||X^2 test|||||||0.162
91524448|NCT02799472|182923978|OTHER||Ratio|0.891||||0.47|TWO_SIDED|95.0|0.647|1.228|||Repeated measures analysis|||MD1C, Week 12||1.228|0.647|0.470
91712880|NCT00327717|183317537|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||X^2 test|||||||0.678
91712881|NCT01630135|183317540|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.089|||<|0.001|TWO_SIDED|95.0|-1.41|-0.76|||ANCOVA||The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.|||-0.76|-1.41|<0.001
91712882|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|7451.0|||||TWO_SIDED|95.0|5857.0|9045.0|||||The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||9045|5857|
91712883|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|11545.0|||||TWO_SIDED|95.0|8827.0|14263.0|||||The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||14263|8827|
91712884|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|61.0|||||TWO_SIDED|95.0|58.0|63.0|||||The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||63|58|
91524449|NCT02799472|182923978|OTHER||Ratio|0.869||||0.401|TWO_SIDED|95.0|0.621|1.217|||Repeated measures analysis|||MD1C, 12-Week FU||1.217|0.621|0.401
91712885|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|51.0|||||TWO_SIDED|95.0|49.0|53.0|||||The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||53|49|
91712886|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|231.0|||||TWO_SIDED|95.0|227.0|234.0|||||The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||234|227|
91712887|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|295.0|||||TWO_SIDED|95.0|290.0|299.0|||||The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||299|290|
91712888|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|873.0|||||TWO_SIDED|95.0|827.0|919.0|||||The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||919|827|
91712889|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|1080.0|||||TWO_SIDED|95.0|1022.0|1138.0|||||The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1138|1022|
91712890|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|1267.0|||||TWO_SIDED|95.0|1251.0|1283.0|||||The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1283|1251|
91712891|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|1250.0|||||TWO_SIDED|95.0|1234.0|1266.0|||||The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1266|1234|
91712892|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|1175.0|||||TWO_SIDED|95.0|1083.0|1267.0|||||The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1267|1083|
91712893|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|1566.0|||||TWO_SIDED|95.0|1438.0|1695.0|||||The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1695|1438|
91712894|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|2991.0|||||TWO_SIDED|95.0|2922.0|3059.0|||||The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3059|2922|
91712895|NCT01387178|183317569|SUPERIORITY_OR_OTHER||Adjusted Mean|3304.0|||||TWO_SIDED|95.0|3221.0|3386.0|||||The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3386|3221|
91712896|NCT01387178|183317570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.2198||95.0|0.909|1.022||Risk of Moderate COPD Exacerbations|Regression, Cox|||||1.022|0.909|0.2198
91712897|NCT01387178|183317570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.0406||95.0|0.752|0.994||Risk of Severe COPD Exacerbations|Regression, Cox|||||0.994|0.752|0.0406
91657920|NCT01691248|183209427|SUPERIORITY_OR_OTHER||Percentage difference|1.9||||0.3091|TWO_SIDED|95.0|-5.5|9.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.2|-5.5|0.3091
91524450|NCT02799472|182923978|OTHER||Ratio|0.981||||0.887|TWO_SIDED|95.0|0.742|1.296|||Repeated measures analysis|||MD2C, Week 1||1.296|0.742|0.887
91524451|NCT02799472|182923978|OTHER||Ratio|0.97||||0.814|TWO_SIDED|95.0|0.744|1.263|||Repeated measures analysis|||MD2C, Week 2||1.263|0.744|0.814
91524452|NCT02799472|182923978|OTHER||Ratio|0.969||||0.794|TWO_SIDED|95.0|0.762|1.233|||Repeated measures analysis|||MD2C, Week 4||1.233|0.762|0.794
91524453|NCT02799472|182923978|OTHER||Ratio|0.919||||0.539|TWO_SIDED|95.0|0.696|1.213|||Repeated measures analysis|||MD2C, Week 6||1.213|0.696|0.539
91524454|NCT02799472|182923978|OTHER||Ratio|0.937||||0.623|TWO_SIDED|95.0|0.719|1.221|||Repeated measures analysis|||MD2C, Week 8||1.221|0.719|0.623
91657921|NCT00993187|183209428|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||ANCOVA|||||-0.6|-1.0|<0.001
91657922|NCT00993187|183209431|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-23.5|||<|0.001|TWO_SIDED|95.0|-30.0|-16.9|||ANCOVA|||||-16.9|-30.0|<0.001
91657923|NCT00993187|183209432|SUPERIORITY_OR_OTHER||Difference in percent|-14.7|||<|0.001|TWO_SIDED|95.0|-23.0|-7.0|||ANCOVA|||||-7.0|-23.0|<0.001
91524455|NCT02799472|182923978|OTHER||Ratio|0.913||||0.467|TWO_SIDED|95.0|0.711|1.173|||Repeated measures analysis|||MD2C, Week 12||1.173|0.711|0.467
91524456|NCT02799472|182923978|OTHER||Ratio|0.778||||0.108|TWO_SIDED|95.0|0.57|1.061|||Repeated measures analysis|||MD2C, 12-Week FU||1.061|0.570|0.108
91524457|NCT02799472|182923978|OTHER||Ratio|1.01||||0.897|TWO_SIDED|95.0|0.868|1.175|||Repeated measures analysis|||MD3C, Week 1||1.175|0.868|0.897
91657924|NCT00993187|183209433|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.72|||<|0.001|TWO_SIDED|95.0|-2.2|-1.25|||ANCOVA|||||-1.25|-2.20|<0.001
91657925|NCT00993187|183209434|SUPERIORITY_OR_OTHER||Difference in percent|41.01|||<|0.001|TWO_SIDED|95.0|30.0|51.0|||ANCOVA|||||51.0|30.0|<0.001
91657926|NCT00549718|183209441|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91657927|NCT00549718|183209442|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91657928|NCT03422653|183209444|SUPERIORITY||Odds Ratio (OR)|2.72|||<|0.001|TWO_SIDED|95.0|1.72|4.3|||Cui, Hung, Wang|||||4.30|1.72|<0.001
91657929|NCT03422653|183209445|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.0|-0.5|||ANCOVA|||||-0.5|-2.0|<0.001
91657930|NCT03422653|183209446|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-8.0|-2.3|||ANCOVA|||||-2.3|-8.0|<0.001
91712898|NCT01387178|183317570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.0962||95.0|0.901|1.009||Risk of Any COPD Exacerbation|Regression, Cox|||||1.009|0.901|0.0962
91657931|NCT03422653|183209447|SUPERIORITY||Odds Ratio (OR)|2.89|||<|0.001|TWO_SIDED|95.0|1.75|4.76|||Cui, Hung, Wang|||||4.76|1.75|<0.001
91657932|NCT01136382|183209460|SUPERIORITY_OR_OTHER||LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|7.5|19.7||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||19.7|7.5|<0.0001
91712899|NCT01246895|183317574|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.017
91524458|NCT02799472|182923978|OTHER||Ratio|1.037||||0.644|TWO_SIDED|95.0|0.884|1.218|||Repeated measures analysis|||MD3C, Week 2||1.218|0.884|0.644
91524459|NCT02799472|182923978|OTHER||Ratio|0.943||||0.53|TWO_SIDED|95.0|0.78|1.139|||Repeated measures analysis|||MD3C, Week 4||1.139|0.780|0.530
91618160|NCT00960934|183129366|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.4||||0.979|TWO_SIDED|95.0|-2.18|2.98||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.98|-2.18|0.979
91618161|NCT00960934|183129366|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.49||||0.979|TWO_SIDED|95.0|-3.27|2.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.30|-3.27|0.979
91618162|NCT00960934|183129366|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.51||||0.979|TWO_SIDED|95.0|-2.34|3.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.37|-2.34|0.979
91618163|NCT00960934|183129367|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.77||||0.02|TWO_SIDED|95.0|2.26|37.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.46|2.26|0.020
91618164|NCT00960934|183129367|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.08||||0.357|TWO_SIDED|95.0|-6.16|26.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||26.41|-6.16|0.357
91712900|NCT01246895|183317575|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.026
91524460|NCT02799472|182923978|OTHER||Ratio|0.882||||0.182|TWO_SIDED|95.0|0.733|1.063|||Repeated measures analysis|||MD3C, Week 6||1.063|0.733|0.182
91524461|NCT02799472|182923978|OTHER||Ratio|0.96||||0.691|TWO_SIDED|10.0|0.779|1.182|||Repeated measures analysis|||MD3C, Week 8||1.182|0.779|0.691
91618165|NCT00960934|183129367|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-2.83||||0.642|TWO_SIDED|95.0|-14.81|9.14||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.14|-14.81|0.642
91618166|NCT00960934|183129367|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.44||||0.434|TWO_SIDED|95.0|-7.09|24.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.04|-7.09|0.434
91618167|NCT00960934|183129367|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.72||||0.579||95.0|-8.62|20.1||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||20.10|-8.62|0.579
91712901|NCT01246895|183317576|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Pain||||0.474
91618168|NCT00960934|183129368|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|34.26|||<|0.001|TWO_SIDED|95.0|15.27|53.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||53.56|15.27|<0.001
91618169|NCT00960934|183129368|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.57||||0.014|TWO_SIDED|95.0|3.28|38.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||38.02|3.28|0.014
91618170|NCT00960934|183129368|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.97||||0.307|TWO_SIDED|95.0|-5.69|25.7||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||25.70|-5.69|0.307
91618171|NCT00960934|183129368|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.02||||0.307|TWO_SIDED|95.0|-5.85|23.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||23.95|-5.85|0.307
91524462|NCT02799472|182923978|OTHER||Ratio|0.979||||0.843|TWO_SIDED|95.0|0.79|1.214|||Repeated measures analysis|||MD3C, Week 12||1.214|0.790|0.843
91524463|NCT02799472|182923978|OTHER||Ratio|1.075||||0.524|TWO_SIDED|95.0|0.855|1.351|||Repeated measures analysis|||MD3C, 12-Week FU||1.351|0.855|0.524
91524464|NCT02799472|182923979|OTHER||Ratio|0.953||||0.558|TWO_SIDED|95.0|0.809|1.123|||Repeated measures analysis|||Helper/Suppressor, Week 1||1.123|0.809|0.558
91524465|NCT02799472|182923979|OTHER||Ratio|0.947||||0.515|TWO_SIDED|95.0|0.801|1.12|||Repeated measures analysis|||Helper/Suppressor, Week 4||1.120|0.801|0.515
91524466|NCT02799472|182923979|OTHER||Ratio|1.046||||0.565|TWO_SIDED|95.0|0.895|1.222|||Repeated measures analysis|||Helper/Suppressor, Week 12||1.222|0.895|0.565
91524467|NCT02799472|182923979|OTHER||Ratio|1.013||||0.897|TWO_SIDED|95.0|0.822|1.249|||Repeated measures analysis|||Helper/Suppressor, 12-Week FU||1.249|0.822|0.897
91524468|NCT02799472|182923980|OTHER||Ratio|1.037||||0.786|TWO_SIDED|95.0|0.794|1.354|||Repeated measures analysis|||CD16+CD56+, Week 1||1.354|0.794|0.786
91524469|NCT02799472|182923980|OTHER||Ratio|0.818||||0.188|TWO_SIDED|95.0|0.603|1.109|||Repeated measures analysis|||CD16+CD56+, Week 4||1.109|0.603|0.188
91524470|NCT02799472|182923980|OTHER||Ratio|0.763||||0.129|TWO_SIDED|95.0|0.536|1.087|||Repeated measures analysis|||CD16+CD56+, Week 12||1.087|0.536|0.129
91524471|NCT02799472|182923980|OTHER||Ratio|0.709||||0.054|TWO_SIDED|95.0|0.499|1.006|||Repeated measures analysis|||CD16+CD56+, 12-Week FU||1.006|0.499|0.054
91657933|NCT01136382|183209461|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.02|0.11||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.11|0.02|0.0047
91657934|NCT01136382|183209462|SUPERIORITY_OR_OTHER||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|3.0||0.0004|TWO_SIDED|95.0|4.9|16.7|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||16.7|4.9|0.0004
91657935|NCT01136382|183209463|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0673|TWO_SIDED|95.0|0.0|0.08|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.08|0.00|0.0673
91657936|NCT01136382|183209464|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.044||0.0216|TWO_SIDED|95.0|0.01|0.19|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.19|0.01|0.0216
91524472|NCT02799472|182923980|OTHER||Ratio|1.119||||0.383|TWO_SIDED|95.0|0.863|1.45|||Repeated measures analysis|||CD19, Week 1||1.450|0.863|0.383
91524473|NCT02799472|182923980|OTHER||Ratio|0.89||||0.51|TWO_SIDED|95.0|0.623|1.271|||Repeated measures analysis|||CD19, Week 4||1.271|0.623|0.510
91524474|NCT02799472|182923980|OTHER||Ratio|0.952||||0.724|TWO_SIDED|95.0|0.718|1.262|||Repeated measures analysis|||CD19, Week 12||1.262|0.718|0.724
91524475|NCT02799472|182923980|OTHER||Ratio|0.958||||0.831|TWO_SIDED|95.0|0.635|1.443|||Repeated measures analysis|||CD19, 12-Week FU||1.443|0.635|0.831
91524476|NCT02799472|182923980|OTHER||Ratio|1.082||||0.437|TWO_SIDED|95.0|0.882|1.328|||Repeated measures analysis|||CD3, Week 1||1.328|0.882|0.437
91524477|NCT02799472|182923980|OTHER||Ratio|0.937||||0.632|TWO_SIDED|95.0|0.711|1.234|||Repeated measures analysis|||CD3, Week 4||1.234|0.711|0.632
91524478|NCT02799472|182923980|OTHER||Ratio|1.088||||0.413|TWO_SIDED|95.0|0.885|1.336|||Repeated measures analysis|||CD3, Week 12||1.336|0.885|0.413
91524479|NCT02799472|182923980|OTHER||Ratio|1.062||||0.567|TWO_SIDED|95.0|0.858|1.316|||Repeated measures analysis|||CD3, 12-Week FU||1.316|0.858|0.567
91524480|NCT02799472|182923980|OTHER||Ratio|1.069||||0.547|TWO_SIDED|95.0|0.855|1.338|||Repeated measures analysis|||CD3+CD4+, Week 1||1.338|0.855|0.547
91524481|NCT02799472|182923980|OTHER||Ratio|0.907||||0.512|TWO_SIDED|95.0|0.673|1.223|||Repeated measures analysis|||CD3+CD4+, Week 4||1.223|0.673|0.512
91524482|NCT02799472|182923980|OTHER||Ratio|1.064||||0.573|TWO_SIDED|95.0|0.853|1.328|||Repeated measures analysis|||CD3+CD4+, Week 12||1.328|0.853|0.573
91524483|NCT02799472|182923980|OTHER||Ratio|1.031||||0.789|TWO_SIDED|95.0|0.818|1.3|||Repeated measures analysis|||CD3+CD4+, 12-Week FU||1.300|0.818|0.789
91524484|NCT02799472|182923981|OTHER||Mean Difference (Net)|0.036||||0.428|TWO_SIDED|95.0|-0.056|0.128|||Repeated measures analysis|||CD3+CD8+, Week 1||0.128|-0.056|0.428
91524485|NCT02799472|182923981|OTHER||Mean Difference (Net)|-0.023||||0.733|TWO_SIDED|95.0|-0.159|0.113|||Repeated measures analysis|||CD3+CD8+, Week 4||0.113|-0.159|0.733
91712902|NCT01246895|183317576|SUPERIORITY_OR_OTHER|||||||0.236|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Stiffness||||0.236
91524486|NCT02799472|182923981|OTHER||Mean Difference (Net)|0.02||||0.677|TWO_SIDED|95.0|-0.076|0.115|||Repeated measures analysis|||CD3+CD8+, Week 12||0.115|-0.076|0.677
91657937|NCT01136382|183209465|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0004|TWO_SIDED|95.0|-0.31|-0.09||Analysis for change in daytime asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.09|-0.31|0.0004
91524487|NCT02799472|182923981|OTHER||Mean Difference (Net)|0.033||||0.569|TWO_SIDED|95.0|-0.084|0.151|||Repeated measures analysis|||CD3+CD8+, 12-Week FU||0.151|-0.084|0.569
91524488|NCT02799472|182923981|OTHER||Mean Difference (Net)|0.103||||0.569|TWO_SIDED|95.0|-0.263|0.469|||Repeated measures analysis|||T Cell B Cell NKL, Week 1||0.469|-0.263|0.569
91524489|NCT02799472|182923981|OTHER||Mean Difference (Net)|-0.157||||0.534|TWO_SIDED|95.0|-0.668|0.354|||Repeated measures analysis|||T Cell B Cell NKL, Week 4||0.354|-0.668|0.534
91524490|NCT02799472|182923981|OTHER||Mean Difference (Net)|0.087||||0.668|TWO_SIDED|95.0|-0.323|0.498|||Repeated measures analysis|||T Cell B Cell NKL, Week 12||0.498|-0.323|0.668
91524491|NCT02799472|182923981|OTHER||Mean Difference (Net)|-0.021||||0.934|TWO_SIDED|95.0|-0.526|0.484|||Repeated measures analysis|||T Cell B Cell NKL, 12-Week FU||0.484|-0.526|0.934
91524492|NCT02799472|182923982|OTHER||Ratio|1.112||||0.369|TWO_SIDED|95.0|0.876|1.412|||Repeated measures analysis|||CD3+ CD4+, Week 1||1.412|0.876|0.369
91524493|NCT02799472|182923982|OTHER||Ratio|0.941||||0.641|TWO_SIDED|95.0|0.721|1.228|||Repeated measures analysis|||CD3+ CD4+, Week 4||1.228|0.721|0.641
91524494|NCT02799472|182923982|OTHER||Ratio|1.024||||0.844|TWO_SIDED|95.0|0.804|1.303|||Repeated measures analysis|||CD3+ CD4+, Week 12||1.303|0.804|0.844
91524495|NCT02799472|182923982|OTHER||Ratio|1.082||||0.558|TWO_SIDED|95.0|0.821|1.427|||Repeated measures analysis|||CD3+ CD4+, 12-Week FU||1.427|0.821|0.558
91524496|NCT02799472|182923982|OTHER||Ratio|1.111||||0.363|TWO_SIDED|95.0|0.88|1.402|||Repeated measures analysis|||CD3+ CD8+, Week 1||1.402|0.880|0.363
91524497|NCT02799472|182923982|OTHER||Ratio|0.957||||0.751|TWO_SIDED|95.0|0.724|1.265|||Repeated measures analysis|||CD3+ CD8+, Week 4||1.265|0.724|0.751
91524498|NCT02799472|182923982|OTHER||Ratio|1.076||||0.537|TWO_SIDED|95.0|0.846|1.37|||Repeated measures analysis|||CD3+ CD8+, Week 12||1.370|0.846|0.537
91524499|NCT02799472|182923982|OTHER||Ratio|1.032||||0.806|TWO_SIDED|95.0|0.797|1.335|||Repeated measures analysis|||CD3+ CD8+, 12-Week FU||1.335|0.797|0.806
91524500|NCT02799472|182923982|OTHER||Ratio|1.101||||0.405|TWO_SIDED|95.0|0.872|1.391|||Repeated measures analysis|||CD3+, Week 1||1.391|0.872|0.405
91524501|NCT02799472|182923982|OTHER||Ratio|0.907||||0.519|TWO_SIDED|95.0|0.668|1.232|||Repeated measures analysis|||CD3+, Week 4||1.232|0.668|0.519
91524502|NCT02799472|182923982|OTHER||Ratio|1.036||||0.748|TWO_SIDED|95.0|0.831|1.291|||Repeated measures analysis|||CD3+, Week 12||1.291|0.831|0.748
91524503|NCT02799472|182923982|OTHER||Ratio|1.049||||0.704|TWO_SIDED|95.0|0.811|1.356|||Repeated measures analysis|||CD3+, 12-Week FU||1.356|0.811|0.704
91524504|NCT02799472|182923983|OTHER||Mean Difference (Net)|6.5||||0.501|TWO_SIDED|95.0|-13.1|26.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 1||26.1|-13.1|0.501
91524505|NCT02799472|182923983|OTHER||Mean Difference (Net)|-1.8||||0.852|TWO_SIDED|95.0|-21.6|18.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 4||18.0|-21.6|0.852
91524506|NCT02799472|182923983|OTHER||Mean Difference (Net)|6.3||||0.572|TWO_SIDED|95.0|-16.4|29.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 12||29.0|-16.4|0.572
91524507|NCT02799472|182923983|OTHER||Mean Difference (Net)|10.5||||0.363|TWO_SIDED|95.0|-13.0|34.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, 12-Week FU||34.1|-13.0|0.363
91524508|NCT02799472|182923983|OTHER||Mean Difference (Net)|2.0||||0.788|TWO_SIDED|95.0|-13.0|17.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 1||17.0|-13.0|0.788
91524509|NCT02799472|182923983|OTHER||Mean Difference (Net)|-2.2||||0.786|TWO_SIDED|95.0|-18.8|14.4|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 4||14.4|-18.8|0.786
91712903|NCT01246895|183317576|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Physical function||||0.326
91524510|NCT02799472|182923983|OTHER||Mean Difference (Net)|-7.1||||0.433|TWO_SIDED|95.0|-25.4|11.2|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 12||11.2|-25.4|0.433
91524511|NCT02799472|182923983|OTHER||Mean Difference (Net)|4.1||||0.55|TWO_SIDED|95.0|-9.8|18.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, 12-Week FU||18.0|-9.8|0.550
91657938|NCT01136382|183209465|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0015|TWO_SIDED|95.0|-0.55|-0.13||Analysis for change in total asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.13|-0.55|0.0015
91657939|NCT01136382|183209466|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0079|TWO_SIDED|95.0|-0.26|-0.04|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.04|-0.26|0.0079
91657940|NCT01136382|183209467|SUPERIORITY_OR_OTHER||LS mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.78||0.0095|TWO_SIDED|95.0|-8.2|-1.1||Analysis for change in nighttime awakenings from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.1|-8.2|0.0095
91657941|NCT01136382|183209467|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.15||0.0007|TWO_SIDED|95.0|-6.2|-1.7||Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.7|-6.2|0.0007
91657942|NCT01136382|183209468|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|-0.4|-0.1||Analysis for change in daytime reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.4|0.0001
91712904|NCT01246895|183317577|SUPERIORITY_OR_OTHER|||||||0.01|||||||Physical count|||||||0.01
91618172|NCT00960934|183129368|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.5||||0.937|TWO_SIDED|95.0|-12.92|11.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||11.92|-12.92|0.937
91524512|NCT02799472|182923984|OTHER||Mean Difference (Net)|14.6||||0.35|TWO_SIDED|95.0|-16.9|46.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1||46.1|-16.9|0.350
91618173|NCT00960934|183129369|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.19|||<|0.001|TWO_SIDED|95.0|7.42|31.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||31.02|7.42|<0.001
91618174|NCT00960934|183129369|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|23.38|||<|0.001|TWO_SIDED|95.0|11.02|35.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||35.82|11.02|<0.001
91618175|NCT00960934|183129369|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.45||||0.061|TWO_SIDED|95.0|-0.37|21.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.30|-0.37|0.061
91712905|NCT01246895|183317578|SUPERIORITY_OR_OTHER|||||||0.478|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Physical component||||0.478
91618176|NCT00960934|183129369|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|6.31||||0.283|TWO_SIDED|95.0|-3.81|16.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||16.45|-3.81|0.283
91524513|NCT02799472|182923984|OTHER||Mean Difference (Net)|8.4||||0.697|TWO_SIDED|95.0|-35.3|52.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4||52.0|-35.3|0.697
91524514|NCT02799472|182923984|OTHER||Mean Difference (Net)|-49.2||||0.249|TWO_SIDED|95.0|-135.2|36.8|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12||36.8|-135.2|0.249
91524515|NCT02799472|182923984|OTHER||Mean Difference (Net)|-30.1||||0.119|TWO_SIDED|95.0|-68.6|8.3|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, 12-Week FU||8.3|-68.6|0.119
91524516|NCT02799472|182923984|OTHER||Mean Difference (Net)|6.5||||0.403|TWO_SIDED|95.0|-9.3|22.4|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1||22.4|-9.3|0.403
91618177|NCT00960934|183129369|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.46||||0.283|TWO_SIDED|95.0|-3.39|14.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||14.31|-3.39|0.283
91618178|NCT00960934|183129370|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|56.77|||<|0.001|TWO_SIDED|95.0|37.62|76.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||76.35|37.62|<.001
91618179|NCT00960934|183129370|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|39.66|||<|0.001|TWO_SIDED|95.0|22.44|57.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||57.17|22.44|<.001
91712906|NCT01246895|183317578|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Mental component||||0.125
91524517|NCT02799472|182923984|OTHER||Mean Difference (Net)|-2.1||||0.91|TWO_SIDED|95.0|-39.4|35.2|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4||35.2|-39.4|0.910
91524518|NCT02799472|182923984|OTHER||Mean Difference (Net)|-6.5||||0.718|TWO_SIDED|95.0|-43.1|30.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12||30.1|-43.1|0.718
91524519|NCT02799472|182923984|OTHER||Mean Difference (Net)|-5.7||||0.687|TWO_SIDED|95.0|-34.4|23.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU||23.0|-34.4|0.687
91524520|NCT02799472|182923984|OTHER||Mean Difference (Net)|-56.0||||0.559|TWO_SIDED|95.0|-249.8|137.7|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 1||137.7|-249.8|0.559
91524521|NCT02799472|182923984|OTHER||Mean Difference (Net)|51.6||||0.47|TWO_SIDED|95.0|-93.9|197.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 4||197.0|-93.9|0.470
91524522|NCT02799472|182923984|OTHER||Mean Difference (Net)|-141.5||||0.675|TWO_SIDED|95.0|-829.2|546.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 12||546.3|-829.2|0.675
91618180|NCT00960934|183129370|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.68||||0.003|TWO_SIDED|95.0|5.72|35.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||35.78|5.72|0.003
91618181|NCT00960934|183129370|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.59||||0.265|TWO_SIDED|95.0|-4.81|22.05||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||22.05|-4.81|0.265
91618182|NCT00960934|183129370|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.39||||0.265|TWO_SIDED|95.0|-3.4|20.21||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||20.21|-3.40|0.265
91618183|NCT00960934|183129371|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|53.05|||<|0.001|TWO_SIDED|95.0|37.83|68.53||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||68.53|37.83|<0.001
91618184|NCT00960934|183129371|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|41.41|||<|0.001|TWO_SIDED|95.0|27.36|55.65||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||55.65|27.36|<0.001
91618185|NCT00960934|183129371|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|24.81|||<|0.001|TWO_SIDED|95.0|12.39|37.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.33|12.39|<0.001
91618186|NCT00960934|183129371|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|12.87||||0.02|TWO_SIDED|95.0|1.73|24.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.06|1.73|0.020
91618187|NCT00960934|183129371|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|4.02||||0.397|TWO_SIDED|95.0|-5.31|13.36||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||13.36|-5.31|0.397
91657943|NCT01136382|183209468|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.2||Analysis for change in total reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.2|-0.7|<0.0001
91657944|NCT01136382|183209469|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.3|<0.0001
91657945|NCT01136382|183209470|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
91657946|NCT01287013|183209484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91524523|NCT02799472|182923984|OTHER||Mean Difference (Net)|-137.9||||0.08|TWO_SIDED|95.0|-294.0|18.2|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, 12-Week FU||18.2|-294.0|0.080
91524524|NCT02799472|182923984|OTHER||Mean Difference (Net)|0.4||||0.989|TWO_SIDED|95.0|-60.5|61.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 1||61.3|-60.5|0.989
91618188|NCT02338492|183129372|SUPERIORITY|||||||0.615||||||P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is \<0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.||Null hypothesis: Mean improvement in VAS over 90 days \<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).||||0.615
91657947|NCT01287013|183209485|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91657948|NCT01287013|183209486|OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<0.04
91657949|NCT01287013|183209487|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91657950|NCT01287013|183209488|SUPERIORITY_OR_OTHER||||||=|0.67|||||||t-test, 2 sided|||||||=0.67
91618189|NCT02338492|183129374|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|96|
91618190|NCT02338492|183129374|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals||100|96|
91618191|NCT02338492|183129374|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||100|93|
91618192|NCT02338492|183129374|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success||100|93|
91618193|NCT02338492|183129374|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|93|
91657951|NCT01179048|183209492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.|Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio \>=1.3).|Regression, Cox|||The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|<0.001
91618194|NCT02338492|183129374|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
91618195|NCT02338492|183129374|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||99|90|
91618196|NCT02338492|183129374|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success||99|90|
91618197|NCT02338492|183129374|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications||99|90|
91618198|NCT02338492|183129374|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
91618199|NCT02338492|183129374|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||98|86|
91618200|NCT02338492|183129374|OTHER||Percentage of Subjects|92.6|||||TWO_SIDED|95.0|85.0|97.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success||97|85|
91618201|NCT02338492|183129374|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications||98|86|
91618202|NCT02338492|183129374|OTHER||Percentage of Subjects|95.1|||||TWO_SIDED|95.0|88.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals||99|88|
91618203|NCT02338492|183129374|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||93|77|
91618204|NCT02338492|183129374|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success||93|77|
91618205|NCT02338492|183129374|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications||96|83|
91618206|NCT02338492|183129374|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals||96|83|
91618207|NCT02338492|183129374|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||90|73|
91618208|NCT02338492|183129374|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success||90|73|
91618209|NCT00980785|183129383|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-22.5|STANDARD_DEVIATION|78.7||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
91618210|NCT00980785|183129383|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-31.71|STANDARD_DEVIATION|90.6||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
91657952|NCT01179048|183209492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.005|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio\>=1.0).|Regression, Cox|||If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR \>=1.0 against Ha: HR \<1.0 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|0.005
91712907|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|0.64|||||TWO_SIDED|95.0|0.37|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.37|
91618211|NCT00980785|183129384|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.21||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
91657953|NCT01179048|183209493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.807|0.962|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.962|0.807|
91657954|NCT01179048|183209494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847|||||TWO_SIDED|95.0|0.739|0.971|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.971|0.739|
91657955|NCT01179048|183209495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783|||||TWO_SIDED|95.0|0.656|0.934|||Regression, Cox|||Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.||0.934|0.656|
91524525|NCT02799472|182923984|OTHER||Mean Difference (Net)|-17.4||||0.634|TWO_SIDED|95.0|-94.3|59.6|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 4||59.6|-94.3|0.634
91618212|NCT00980785|183129384|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.32||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
91618213|NCT00980785|183129385|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|1.56||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
91618214|NCT00980785|183129385|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-0.29|STANDARD_DEVIATION|1.23||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
91618215|NCT00980785|183129386|OTHER|Mann-Whitney test|Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|8.9||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
91618216|NCT00980785|183129386|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|2.2||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
91618217|NCT05209932|183129436|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
91618218|NCT05209932|183129437|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED||||||ANCOVA|||||||0.05
91618219|NCT05209932|183129438|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
91618220|NCT05209932|183129439|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
91618221|NCT05209932|183129440|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
91618222|NCT05209932|183129441|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
91618223|NCT05209932|183129442|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
91618224|NCT05209932|183129443|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
91618225|NCT05209932|183129444|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
91618226|NCT05209932|183129445|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
91618227|NCT05209932|183129446|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED||||||ANCOVA|||||||0.43
91618228|NCT05209932|183129447|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.14||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
91618229|NCT05209932|183129448|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
91618230|NCT05209932|183129449|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||ANCOVA|||||||0.63
91657956|NCT01179048|183209495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.894|||||TWO_SIDED|95.0|0.721|1.107|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor||1.107|0.721|
91657957|NCT01179048|183209495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.747|1.031|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor||1.031|0.747|
91657958|NCT01179048|183209495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.763|1.258|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor||1.258|0.763|
91712908|NCT03311841|183317584|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.77|2.31||||||Comparison of midazolam||2.31|0.77|
91712909|NCT03311841|183317584|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.56|1.62||||||Comparison of midazolam||1.62|0.56|
91524526|NCT02799472|182923984|OTHER||Mean Difference (Net)|59.4||||0.789|TWO_SIDED|95.0|-395.2|513.9|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 12||513.9|-395.2|0.789
91618231|NCT05209932|183129450|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.8||0.29|TWO_SIDED||||||ANCOVA|||||||0.29
91618232|NCT05209932|183129451|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|1.12||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
91657959|NCT01179048|183209495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912|||||TWO_SIDED|95.0|0.797|1.044|||Regression, Cox|||Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor||1.044|0.797|
91657960|NCT01179048|183209495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|||||TWO_SIDED|95.0|0.727|1.046|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor||1.046|0.727|
91657961|NCT01179048|183209496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841|||||TWO_SIDED|95.0|0.73|0.969|||Regression, Cox|||Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.||0.969|0.730|
91657962|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.782|||||TWO_SIDED|95.0|0.666|0.918|||Regression, Cox|||Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.||0.918|0.666|
91524527|NCT02799472|182923984|OTHER||Mean Difference (Net)|-47.2||||0.249|TWO_SIDED|95.0|-135.5|41.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, 12-Week FU||41.0|-135.5|0.249
91618233|NCT05209932|183129452|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
91618234|NCT05209932|183129453|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.42|TWO_SIDED||||||ANCOVA|||||||0.42
91618235|NCT05209932|183129454|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.97|TWO_SIDED||||||ANCOVA|||||||0.97
91618236|NCT01757405|183129473|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].|Ratio of success proportion|1.21|||||TWO_SIDED|90.0|1.15|1.28|||Ratio of success proportion|||Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms. Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 : p1/p2 \< 0.83 and H02 : p1/p2 \> 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].||1.28|1.15|
91618237|NCT01219959|183129485|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
91618238|NCT01219959|183129485|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
91657963|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738|||||TWO_SIDED|95.0|0.602|0.905|||Regression, Cox|||Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.||0.905|0.602|
91657964|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.667|1.189|||Regression, Cox|||Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.||1.189|0.667|
91657965|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.869|||||TWO_SIDED|95.0|0.607|1.244|||Regression, Cox|||Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.||1.244|0.607|
91657966|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593|||||TWO_SIDED|95.0|0.521|4.869|||Regression, Cox|||Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.||4.869|0.521|
91657967|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.869|1.519|||Regression, Cox|||Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.||1.519|0.869|
91657968|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.159|||||TWO_SIDED|95.0|0.869|1.546|||Regression, Cox|||Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.||1.546|0.869|
91657969|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.335|||||TWO_SIDED|95.0|0.004|30.847|||Regression, Cox|||Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.||30.847|0.004|
91657970|NCT01179048|183209497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.454|||||TWO_SIDED|95.0|0.845|2.502|||Regression, Cox|||Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.||2.502|0.845|
91657971|NCT03203447|183209501|SUPERIORITY||Difference in percentages|-7.1||||0.191|TWO_SIDED|95.0|-17.9|3.6||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.6|-17.9|0.191
91657972|NCT00445003|183209513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|||<|0.001|TWO_SIDED|95.0|2.2|9.0||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparison|||9.0|2.2|<.001
91657973|NCT00445003|183209513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.2|10.1||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparisons|||10.1|3.2|<.001
91657974|NCT00445003|183209515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.0|||<|0.01|TWO_SIDED|95.0|-64.0|-6.0||Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-6|-64|<.01
91657975|NCT00445003|183209515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.0|||<|0.001|TWO_SIDED|95.0|-128.0|-71.0||adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-71|-128|<.001
91657976|NCT00445003|183209517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.44|TWO_SIDED|95.0|-3.7|7.5||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||7.5|-3.7|0.44
91657977|NCT00445003|183209517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.63|TWO_SIDED|95.0|-4.4|6.8||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||6.8|-4.4|0.63
91618239|NCT01219959|183129486|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
91618240|NCT01219959|183129486|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
91618241|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
91618242|NCT01219959|183129488|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
91618243|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
91657978|NCT00445003|183209520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-0.2|-1.0|0.001
91657979|NCT00445003|183209520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-1.3|-2.1|<.001
91657980|NCT00528606|183209524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.||||<0.001
91657981|NCT01239121|183209766|SUPERIORITY_OR_OTHER||Slope|0.6||||0.175|TWO_SIDED|95.0|-0.27|1.5|||Regression, Linear|||||1.5|-0.27|0.175
91657982|NCT01239121|183209767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.964|TWO_SIDED|95.0|0.49|2.1|||Regression, Logistic|||||2.1|.49|0.964
91657983|NCT04006171|183209771|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91657984|NCT04006171|183209772|OTHER|||||||0.004|||||||Roc curve|||||||0.004
91657985|NCT04006171|183209773|OTHER|||||||0.171||||||p value for FSH|Wilcoxon (Mann-Whitney)|for FSH||||||0.171
91657986|NCT04006171|183209773|OTHER|||||||0.176||||||p value for LH|Wilcoxon (Mann-Whitney)|for LH||||||0.176
91657987|NCT04006171|183209774|OTHER|||||||0.306|||||||Wilcoxon (Mann-Whitney)|||||||0.306
91657988|NCT04006171|183209775|OTHER|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||||||0.795
91657989|NCT04006171|183209776|OTHER|||||||0.852|||||||t-test, 2 sided|||||||0.852
91657990|NCT04006171|183209777|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91657991|NCT04006171|183209778|OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
91657992|NCT04006171|183209779|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
91657993|NCT04006171|183209780|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91524528|NCT02799472|182923984|OTHER||Mean Difference (Net)|3682.3||||0.234|TWO_SIDED|95.0|-2511.9|9876.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 1||9876.5|-2511.9|0.234
91657994|NCT04006171|183209781|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91657995|NCT04006171|183209782|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91657996|NCT04006171|183209783|OTHER|||||||0.947||||||for serum glucose|Wilcoxon (Mann-Whitney)|for serum glucose||||||0.947
91657997|NCT04006171|183209783|OTHER|||||||0.906||||||for total cholesterol|Wilcoxon (Mann-Whitney)|for total cholesterol||||||0.906
91657998|NCT04006171|183209783|OTHER|||||||0.428||||||for triglycerides|Wilcoxon (Mann-Whitney)|for triglycerides||||||0.428
91657999|NCT04006171|183209784|OTHER|||||||0.114||||||for high density lipoprotein|t-test, 2 sided|||||||0.114
91658000|NCT04006171|183209784|OTHER|||||||0.504||||||for low density lipoprotein|Wilcoxon (Mann-Whitney)|for low density lipoprotein||||||0.504
91658001|NCT04006171|183209785|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
91658002|NCT04006171|183209786|OTHER|||||||0.886|||||||Wilcoxon (Mann-Whitney)|||||||0.886
91658003|NCT00440557|183209799|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.17|STANDARD_ERROR_OF_MEAN|0.106||||95.0|-0.38|0.037||This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.||0.037|-0.380|
91658004|NCT00440557|183209799|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.107||||95.0|-0.641|-0.221||Since the non-inferiority was declared in the statistical analysis 1, this comparison between Q2W and TIW was then performed according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.||-0.221|-0.641|
91658005|NCT00440557|183209800|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-7.8||||||95.0|-17.2|1.7||||||||1.7|-17.2|
91658006|NCT00440557|183209800|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-15.0||||||95.0|-25.0|-5.0||||||||-5.0|-25.0|
91658007|NCT00440557|183209801|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.26||||||95.0|-0.564|0.043|||ANOVA|||||0.043|-0.564|
91524529|NCT02799472|182923984|OTHER||Mean Difference (Net)|-547.6||||0.875|TWO_SIDED|95.0|-7612.6|6517.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 4||6517.3|-7612.6|0.875
91658008|NCT00440557|183209801|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.45||||||95.0|-0.755|-0.147|||ANOVA|||||-0.147|-0.755|
91658009|NCT00440557|183209802|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.9||||||95.0|-9.5|1.6||||||||1.6|-9.5|
91524530|NCT02799472|182923984|OTHER||Mean Difference (Net)|-1106.0||||0.815|TWO_SIDED|95.0|-10706.0|8494.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 12||8494.1|-10706.0|0.815
91524531|NCT02799472|182923984|OTHER||Mean Difference (Net)|-3631.0||||0.23|TWO_SIDED|95.0|-9738.9|2476.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, 12-Week FU||2476.8|-9738.9|0.230
91658010|NCT00440557|183209802|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-5.5||||||95.0|-11.4|0.3||||||||0.3|-11.4|
91658011|NCT00440557|183209803|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-2.7||||||95.0|-14.2|8.7||||||||8.7|-14.2|
91658012|NCT00440557|183209803|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-9.9||||||95.0|-21.7|1.8||||||||1.8|-21.7|
91524532|NCT02799472|182923984|OTHER||Mean Difference (Net)|-515.6||||0.489|TWO_SIDED|95.0|-2021.4|990.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 1||990.1|-2021.4|0.489
91524533|NCT02799472|182923984|OTHER||Mean Difference (Net)|-199.8||||0.822|TWO_SIDED|95.0|-2001.7|1602.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 4||1602.0|-2001.7|0.822
91618244|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
91618245|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
91618246|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
91618247|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
91618248|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
91618249|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
91618250|NCT01219959|183129488|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
91618251|NCT01219959|183129489|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
91618252|NCT01219959|183129489|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
91618253|NCT01219959|183129489|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
91618254|NCT01219959|183129489|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
91618255|NCT01219959|183129489|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
91618256|NCT01219959|183129489|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
91524534|NCT02799472|182923984|OTHER||Mean Difference (Net)|-253.5||||0.784|TWO_SIDED|95.0|-2136.7|1629.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 12||1629.7|-2136.7|0.784
91524535|NCT02799472|182923984|OTHER||Mean Difference (Net)|225.1||||0.804|TWO_SIDED|95.0|-1633.1|2083.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, 12-Week FU||2083.2|-1633.1|0.804
91618257|NCT01219959|183129490|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
91618258|NCT01219959|183129490|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
91618259|NCT01219959|183129490|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
91618260|NCT01219959|183129490|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
91618261|NCT01219959|183129491|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
91618262|NCT01219959|183129491|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
91618263|NCT01219959|183129492|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
91618264|NCT01219959|183129493|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
91618265|NCT01219959|183129493|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
91618266|NCT01219959|183129493|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
91618267|NCT01219959|183129493|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
91618268|NCT01219959|183129494|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
91618269|NCT01219959|183129494|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
91618270|NCT01219959|183129494|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
91618271|NCT01219959|183129494|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
91618272|NCT01219959|183129495|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
91658013|NCT00440557|183209804|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|2.6||||||95.0|-9.6|14.8||||||||14.8|-9.6|
91791532|NCT01634191|183460882|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.1|135.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.1|
91618273|NCT01219959|183129495|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
91618274|NCT01219959|183129496|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
91791533|NCT01634191|183460883|OTHER||Geometric Mean Ratio|131.0|||||TWO_SIDED|90.0|109.0|157.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||157|109|
91791534|NCT01634191|183460884|OTHER||Geometric Mean Ratio|106.0|||||TWO_SIDED|90.0|90.5|123.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||123|90.5|
91791535|NCT01634191|183460885|OTHER||Geometric Mean Ratio|108.0|||||TWO_SIDED|90.0|92.3|126.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||126|92.3|
91791536|NCT01634191|183460886|OTHER||Median Difference|0.5||||0.153|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Elderly - Young) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.153
91791537|NCT01634191|183460887|OTHER||Median Difference|0.5||||0.169|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Female - Male) and 90% CI of the difference calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.169
91791538|NCT01252732|183460914|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|-2.7|||||TWO_SIDED|95.0|-7.5|2.0||||||||2.0|-7.5|
91791539|NCT01252732|183460915|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|2.2|||||TWO_SIDED|95.0|-2.6|7.0||||||||7.0|-2.6|
91791540|NCT01252732|183460916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|0.6|||||TWO_SIDED|95.0|-3.7|5.0||||||||5.0|-3.7|
91791541|NCT03274999|183460930|SUPERIORITY|||||||0.156||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.156
91791542|NCT03274999|183460930|SUPERIORITY|||||||0.395||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.395
91791543|NCT03274999|183460930|SUPERIORITY|||||||0.114||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.114
91791544|NCT03274999|183460930|SUPERIORITY|||||||0.211||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.211
91618275|NCT01219959|183129496|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
91618276|NCT01219959|183129497|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
91658014|NCT00440557|183209804|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.0||||||95.0|-15.0|9.0||||||||9.0|-15.0|
91618277|NCT01219959|183129497|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
91658015|NCT00440557|183209805|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|0.03||||||95.0|-0.21|0.27|||ANOVA|||||0.270|-0.210|
91618278|NCT01219959|183129498|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
91618279|NCT01219959|183129499|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
91618280|NCT01219959|183129499|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
91618281|NCT01219959|183129499|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
91618282|NCT01219959|183129499|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
91618283|NCT01219959|183129500|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
91618284|NCT01219959|183129500|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
91618285|NCT01219959|183129501|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
91618286|NCT01219959|183129501|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
91618287|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
91618288|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
91618289|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
91618290|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
91618291|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
91618292|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
91618293|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
91618294|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
91618295|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
91618296|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
91618297|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
91618298|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
91618299|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
91618300|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
91618301|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
91618302|NCT01219959|183129502|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
91618303|NCT01219959|183129503|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
91618304|NCT01219959|183129503|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
91618305|NCT01219959|183129504|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
91618306|NCT01219959|183129504|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
91618307|NCT01219959|183129505|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
91618308|NCT01219959|183129505|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
91618309|NCT01219959|183129506|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
91618310|NCT01980706|183129560|SUPERIORITY||Mean Difference (Net)|4.16||||0.018|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.018
91658016|NCT00440557|183209805|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.07||||||95.0|-0.315|0.166|||ANOVA|||||0.166|-0.315|
91618311|NCT01980706|183129561|SUPERIORITY||Mean Difference (Net)|3.68||||0.028|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.028
91618312|NCT01980706|183129562|SUPERIORITY||Mean Difference (Net)|0.65||||0.52|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.52
91618313|NCT01980706|183129563|SUPERIORITY||Mean Difference (Net)|0.84||||0.43|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.43
91658017|NCT00440557|183209806|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-8.8||||||95.0|-16.0|-1.9||||||||-1.9|-16|
91658018|NCT00440557|183209806|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-10.0||||||95.0|-18.0|-3.2||||||||-3.2|-18.0|
91658019|NCT01939197|183209807|NON_INFERIORITY|The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).|||||||||||||||||"The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).~Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61."|||
91658020|NCT01939197|183209808|OTHER|||||||1|||||||Fisher Exact|||||||1.000
91658021|NCT01939197|183209809|OTHER||||||||||||||||||"The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as not available."|||
91658022|NCT04977336|183209840|SUPERIORITY|||||||0.3706|||||||ANCOVA|||||||0.3706
91658023|NCT04977336|183209840|SUPERIORITY|||||||0.5379|||||||ANCOVA|||||||0.5379
91658024|NCT04977336|183209840|SUPERIORITY|||||||0.3859|||||||ANCOVA|||||||0.3859
91658025|NCT04977336|183209840|SUPERIORITY|||||||0.0251|||||||ANCOVA|||||||0.0251
91658026|NCT04977336|183209841|SUPERIORITY|||||||0.2318|||||||ANCOVA|||||||0.2318
91658027|NCT04977336|183209841|SUPERIORITY|||||||0.7615|||||||ANCOVA|||||||0.7615
91658028|NCT04977336|183209841|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.3870
91524536|NCT02799472|182923984|OTHER||Mean Difference (Net)|162.7||||0.719|TWO_SIDED|95.0|-754.5|1079.9|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 1||1079.9|-754.5|0.719
91618314|NCT01980706|183129564|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6|TWO_SIDED|||||Threshold for significance is \<.05|ANCOVA|Adjusted for baseline|Estimated parameter is the overall treatment main effect F statistic from the fitted ANCOVA model assessing the null hypothesis of equal values across the three groups|||||0.60
91618315|NCT01980706|183129565|SUPERIORITY||Table probability for Fisher's Exact|0.002||||0.07|TWO_SIDED|||||Threshold for significance is \<.05|Fisher Exact|||||||0.07
91658029|NCT04977336|183209841|SUPERIORITY|||||||0.0823|||||||ANCOVA|||||||0.0823
91524537|NCT02799472|182923984|OTHER||Mean Difference (Net)|-183.5||||0.742|TWO_SIDED|95.0|-1317.4|950.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 4||950.3|-1317.4|0.742
91618316|NCT02841787|183129603|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||< .001
91618317|NCT02841787|183129603|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||<.001
91618318|NCT02841787|183129603|SUPERIORITY|||||||0.44||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.44
91618319|NCT02841787|183129603|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|ANOVA|||||||0.03
91618320|NCT02841787|183129603|SUPERIORITY|||||||0.68||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.68
91618321|NCT02841787|183129603|SUPERIORITY|||||||0.02||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.02
91658030|NCT04977336|183209842|SUPERIORITY|||||||0.9986|||||||Cochran-Mantel-Haenszel|||||||0.9986
91658031|NCT04977336|183209842|SUPERIORITY|||||||0.4446|||||||Cochran-Mantel-Haenszel|||||||0.4446
91658032|NCT04977336|183209842|SUPERIORITY|||||||0.5978|||||||Cochran-Mantel-Haenszel|||||||0.5978
91658033|NCT04977336|183209842|SUPERIORITY|||||||0.0479|||||||Cochran-Mantel-Haenszel|||||||0.0479
91658034|NCT04977336|183209843|SUPERIORITY|||||||0.9895|||||||Cochran-Mantel-Haenszel|||||||0.9895
91658035|NCT04977336|183209843|SUPERIORITY|||||||0.2731|||||||Cochran-Mantel-Haenszel|||||||0.2731
91658036|NCT04977336|183209843|SUPERIORITY|||||||0.6492|||||||Cochran-Mantel-Haenszel|||||||0.6492
91658037|NCT04977336|183209843|SUPERIORITY|||||||0.5119|||||||Cochran-Mantel-Haenszel|||||||0.5119
91658038|NCT04977336|183209844|SUPERIORITY|||||||0.3158|||||||Cochran-Mantel-Haenszel|||||||0.3158
91658039|NCT04977336|183209844|SUPERIORITY|||||||0.3247|||||||Cochran-Mantel-Haenszel|||||||0.3247
91658040|NCT04977336|183209844|SUPERIORITY|||||||0.8424|||||||Cochran-Mantel-Haenszel|||||||0.8424
91658041|NCT04977336|183209844|SUPERIORITY|||||||0.2312|||||||Cochran-Mantel-Haenszel|||||||0.2312
91658042|NCT02480764|183209862|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-1.932|STANDARD_ERROR_OF_MEAN|1.4512||0.184|TWO_SIDED|95.0|-4.782|0.918||Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||0.918|-4.782|0.184
91658043|NCT02480764|183209862|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-3.685|STANDARD_ERROR_OF_MEAN|1.4344||0.01|TWO_SIDED|95.0|-6.502|-0.868||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||-0.868|-6.502|0.010
91658044|NCT02480764|183209863|OTHER||Least Square Mean Difference|-1.459|STANDARD_ERROR_OF_MEAN|0.9455||0.123|TWO_SIDED|95.0|-3.316|0.397||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||0.397|-3.316|0.123
91658045|NCT02480764|183209863|OTHER||Least Square Mean Difference|-2.822|STANDARD_ERROR_OF_MEAN|0.9354||0.003|TWO_SIDED|95.0|-4.659|-0.985||Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||-0.985|-4.659|0.003
91791545|NCT03274999|183460930|SUPERIORITY|||||||0.332||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.332
91618322|NCT02841787|183129603|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.03
91618323|NCT02841787|183129606|SUPERIORITY|||||||0.003||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.003
91618324|NCT00091390|183129680|SUPERIORITY_OR_OTHER_LEGACY||hazard rate|0.0014|||<|0.0001|TWO_SIDED|95.0|0.0|0.003|||Z-test|One-sided.||The study is designed to test whether the 18-month late GU/GI toxicity following the protocol treatment is above 10% (hazard rate of 0.012/month). The sample size is determined so that the probability of rejecting the treatment because of excessive late toxicity is 90% if the true late toxicity rate is 20% (hazard rate of 0.025/month). Ninety-eight patients are required to with an additional 18 months of follow-up to have a statistical power of 90% with one-sided significance level of 0.05.||0.003|0|<0.0001
91618325|NCT02320695|183129719|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.187|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.05|-0.33|0.187
91618326|NCT02320695|183129719|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.101|TWO_SIDED|95.0|-0.42|0.04|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.04|-0.42|0.101
91618327|NCT02320695|183129719|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.10|-0.49|0.002
91618328|NCT02320695|183129719|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.53|-0.12|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.12|-0.53|<0.001
91618329|NCT02320695|183129720|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.023|TWO_SIDED|95.0|-0.54|-0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.05|-0.54|0.023
91618330|NCT02320695|183129720|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.522|TWO_SIDED|95.0|-0.32|0.2|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.20|-0.32|0.522
91618331|NCT02320695|183129720|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.16|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.16|-0.67|<0.001
91618332|NCT02320695|183129720|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.013|TWO_SIDED|95.0|-0.63|-0.07|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.07|-0.63|0.013
91618333|NCT02622724|183129740|SUPERIORITY|||||||0.8219|||||||Van Elteren hypothesis test|||A non-parametric analysis has been used as the data distribution was skewed. This involved a generalised Wilcoxon rank sum-based stratification test which assigns ranks within strata and compares two treatments within strata (Van Elteren hypothesis test).||||0.8219
91618334|NCT02622724|183129747|SUPERIORITY|||||||0.4678|||||||Van Elteren p-values|||Van Elteren hypothesis test was used as the distribution was non-normal and negatively skewed by patients who are assigned scores of zero in the event of death.||||0.4678
91618335|NCT02622724|183129752|SUPERIORITY||||||<|0.05|||||||ANCOVA|Analysis of covariance (ANCOVA) model using Type III sums of squares with Treatment, Severity, and Country fixed effect factors, Baseline as covariate||||||<0.05
91618336|NCT02622724|183129755|OTHER||Least Squares Mean|31.1|||>|0.05|TWO_SIDED|95.0|-37.7|99.9|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95% Confidence Intervals) for the overall treatment difference for maximum distance walked on Day 180.||99.9|-37.7|>0.05
91618337|NCT02622724|183129769|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL -1ra - changes in levels from baseline to Day 14||||>0.05
91618338|NCT02622724|183129769|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL- 6 - changes in levels from baseline to Day 14||||>0.05
91712910|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.23|
91618339|NCT02622724|183129769|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED|95.0|||||ANCOVA|ANCOVA estimates (LS means and a 95% CI for the treatment difference) were presented for all numeric biomarker variables.||FGF basic - changes in levels from baseline to Day 14||||<0.05
91618340|NCT02622724|183129769|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IP-10 - changes in levels from baseline to Day 14.||||<0.05
91618341|NCT02622724|183129769|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||TNF-α - changes in levels from baseline to Day 14||||>0.05
91618342|NCT02622724|183129770|OTHER||||||<|0.007||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|||||||<0.007
91618343|NCT02622724|183129773|OTHER||Least Squares Mean|28.0|||>|0.05|TWO_SIDED|95.0|-54.0|110.1|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95 % Confidence Intervals) for the overall treatment difference for maximun distance walked on Day 360.||110.1|-54|>0.05
91524538|NCT02799472|182923984|OTHER||Mean Difference (Net)|-268.5||||0.658|TWO_SIDED|95.0|-1507.5|970.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 12||970.5|-1507.5|0.658
91618344|NCT01290445|183129792|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.46|1.47||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.47|0.46|
91618345|NCT01290445|183129792|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.45|1.42||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.45|
91618346|NCT01290445|183129793|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.09|4.34||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.34|0.09|
91618347|NCT01290445|183129793|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.09|4.67||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.67|0.09|
91618348|NCT01290445|183129794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.5|0.96||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.96|0.50|
91618349|NCT01290445|183129794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.51|0.97||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.97|0.51|
91618350|NCT01290445|183129795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.42||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.63|
91618351|NCT01290445|183129795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.61|1.37||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.37|0.61|
91618352|NCT01290445|183129796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
91618353|NCT01290445|183129796|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
91524539|NCT02799472|182923984|OTHER||Mean Difference (Net)|-197.6||||0.755|TWO_SIDED|95.0|-1499.3|1104.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, 12-Week FU||1104.2|-1499.3|0.755
91618354|NCT05439460|183129805|OTHER|||||||0.9|||||||t-test, 2 sided|||Change in phenylephrine group||||0.9
91658046|NCT02480764|183209864|OTHER||Odds Ratio (OR)|0.877|STANDARD_ERROR_OF_MEAN|0.192||0.548|TWO_SIDED|95.0|0.571|1.347||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.347|0.571|0.548
91658047|NCT02480764|183209864|OTHER||Odds Ratio (OR)|0.979|STANDARD_ERROR_OF_MEAN|0.2136||0.921|TWO_SIDED|95.0|0.638|1.501||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.501|0.638|0.921
91658048|NCT02480764|183209865|OTHER||Odds Ratio (OR)|1.033|STANDARD_ERROR_OF_MEAN|0.2805||0.904|TWO_SIDED|95.0|0.607|1.759||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.759|0.607|0.904
91658049|NCT02480764|183209865|OTHER||Odds Ratio (OR)|1.074|STANDARD_ERROR_OF_MEAN|0.2897||0.79|TWO_SIDED|95.0|0.633|1.823||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.823|0.633|0.790
91658050|NCT02480764|183209866|OTHER||Odds Ratio (OR)|0.901|STANDARD_ERROR_OF_MEAN|0.1916||0.624|TWO_SIDED|95.0|0.594|1.367||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.367|0.594|0.624
91658051|NCT02480764|183209866|OTHER||Odds Ratio (OR)|1.103|STANDARD_ERROR_OF_MEAN|0.235||0.647|TWO_SIDED|95.0|0.726|1.674||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.674|0.726|0.647
91618355|NCT05439460|183129805|OTHER|||||||0.3||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in arginine vasopressin group||||0.3
91618356|NCT05439460|183129805|OTHER|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in epinephrine group||||1
91618357|NCT01332019|183129839|SUPERIORITY_OR_OTHER||rate ratio|0.755||||0.0203|TWO_SIDED|95.0|0.595|0.957||q2w/q4w|negative binomial regression|||Based on negative binomial regression for each treatment group, with adjustment for EDSS (\<4 vs. \>=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (\<40 vs. \>=40) at 105MS302 baseline.||0.957|0.595|0.0203
91618358|NCT01332019|183129840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0201|TWO_SIDED|95.0|0.59|0.96||Based on Cox proportion hazards model, adjusted for EDSS (\<4 vs \>= 4), age (\<40 vs \>=40), relapse rate (based on one year before 105MS301 and 105MS301), and gadolinium (Gd) enhancing lesions (presence vs. absence) at 105MS302 baseline.|Cox proportion hazards model|||q2w/q4w||0.96|0.59|0.0201
91618359|NCT01332019|183129841|SUPERIORITY_OR_OTHER||lesion mean ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.63||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of T2 lesions.|negative binomial regression|||Week 48||0.63|0.41|<0.0001
91618360|NCT01332019|183129841|SUPERIORITY_OR_OTHER||lesion mean ratio|0.49|||<|0.0001|TWO_SIDED|95.0|0.39|0.62||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 302 baseline number of T2 lesions.|negative binomial regression|||Week 96||0.62|0.39|<0.0001
91618361|NCT01332019|183129842|SUPERIORITY_OR_OTHER||lesion mean ratio|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 48||0.68|0.43|<0.0001
91658052|NCT02480764|183209867|OTHER||Odds Ratio (OR)|0.831|STANDARD_ERROR_OF_MEAN|0.1846||0.404|TWO_SIDED|95.0|0.537|1.284||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.284|0.537|0.404
91658053|NCT02480764|183209867|OTHER||Odds Ratio (OR)|0.937|STANDARD_ERROR_OF_MEAN|0.2078||0.768|TWO_SIDED|95.0|0.606|1.447||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.447|0.606|0.768
91791546|NCT03274999|183460930|SUPERIORITY|||||||0.318||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
91791547|NCT03274999|183460930|SUPERIORITY|||||||0.375||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.375
91791548|NCT03274999|183460930|SUPERIORITY|||||||0.352||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.352
91791549|NCT03274999|183460930|SUPERIORITY|||||||0.312||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.312
91791550|NCT03274999|183460930|SUPERIORITY|||||||0.134||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.134
91791551|NCT03274999|183460930|SUPERIORITY|||||||0.315||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.315
91524540|NCT02799472|182923984|OTHER||Mean Difference (Net)|1150.0||||0.333|TWO_SIDED|95.0|-1250.0|3550.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 1||3550.0|-1250.0|0.333
91618362|NCT01332019|183129842|SUPERIORITY_OR_OTHER||lesion mean ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.71||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 96||0.71|0.43|<0.0001
91658054|NCT02480764|183209867|OTHER||Odds Ratio (OR)|1.051|STANDARD_ERROR_OF_MEAN|0.2837||0.852|TWO_SIDED|95.0|0.62|1.784||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.784|0.620|0.852
91658055|NCT02480764|183209867|OTHER||Odds Ratio (OR)|1.045|STANDARD_ERROR_OF_MEAN|0.2788||0.868|TWO_SIDED|95.0|0.62|1.763||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.763|0.620|0.868
91791552|NCT03274999|183460930|SUPERIORITY|||||||0.071||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.071
91791553|NCT03274999|183460930|SUPERIORITY|||||||0.26||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.260
91791554|NCT03274999|183460930|SUPERIORITY|||||||0.264||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.264
91791555|NCT03274999|183460930|SUPERIORITY|||||||0.381||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.381
91791556|NCT03274999|183460930|SUPERIORITY|||||||0.249||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.249
91791557|NCT03274999|183460930|SUPERIORITY|||||||0.451||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.451
91791558|NCT03274999|183460930|SUPERIORITY|||||||0.393||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.393
91791559|NCT03274999|183460931|SUPERIORITY|||||||0.006||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.006
91791560|NCT03274999|183460931|SUPERIORITY|||||||0.063||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.063
91524541|NCT02799472|182923984|OTHER||Mean Difference (Net)|-268.0||||0.891|TWO_SIDED|95.0|-4269.2|3733.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 4||3733.3|-4269.2|0.891
91618363|NCT01332019|183129843|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 48||||<0.0001
91524542|NCT02799472|182923984|OTHER||Mean Difference (Net)|-1347.4||||0.633|TWO_SIDED|95.0|-7073.1|4378.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 12||4378.3|-7073.1|0.633
91658056|NCT02480764|183209867|OTHER||Odds Ratio (OR)|1.042|STANDARD_ERROR_OF_MEAN|0.2244||0.847|TWO_SIDED|95.0|0.684|1.59||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.590|0.684|0.847
91524543|NCT02799472|182923984|OTHER||Mean Difference (Net)|-1688.9||||0.41|TWO_SIDED|95.0|-5864.1|2486.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, 12-Week FU||2486.2|-5864.1|0.410
91524544|NCT02799472|182923984|OTHER||Mean Difference (Net)|3276.8||||0.196|TWO_SIDED|95.0|-1786.0|8339.6|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 1||8339.6|-1786.0|0.196
91524545|NCT02799472|182923984|OTHER||Mean Difference (Net)|-447.3||||0.894|TWO_SIDED|95.0|-7285.5|6390.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 4||6390.8|-7285.5|0.894
91658057|NCT02480764|183209867|OTHER||Odds Ratio (OR)|1.172|STANDARD_ERROR_OF_MEAN|0.2517||0.46|TWO_SIDED|95.0|0.769|1.785||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.785|0.769|0.460
91658058|NCT02480764|183209868|OTHER||Odds Ratio (OR)|1.487|STANDARD_ERROR_OF_MEAN|0.3333||0.077|TWO_SIDED|95.0|0.958|2.307||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.307|0.958|0.077
91658059|NCT02480764|183209868|OTHER||Odds Ratio (OR)|1.914|STANDARD_ERROR_OF_MEAN|0.4229||0.003|TWO_SIDED|95.0|1.241|2.951||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.951|1.241|0.003
91658060|NCT02480764|183209868|OTHER||Odds Ratio (OR)|1.427|STANDARD_ERROR_OF_MEAN|0.3414||0.137|TWO_SIDED|95.0|0.893|2.28||Clinic DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||2.280|0.893|0.137
91658061|NCT02480764|183209868|OTHER||Odds Ratio (OR)|2.017|STANDARD_ERROR_OF_MEAN|0.4816||0.003|TWO_SIDED|95.0|1.263|3.22||Clinic DBP \<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||3.220|1.263|0.003
91658062|NCT02480764|183209868|OTHER||Odds Ratio (OR)|1.424|STANDARD_ERROR_OF_MEAN|0.3407||0.14|TWO_SIDED|95.0|0.891|2.276||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.276|0.891|0.140
91658063|NCT02480764|183209868|OTHER||Odds Ratio (OR)|1.769|STANDARD_ERROR_OF_MEAN|0.4136||0.015|TWO_SIDED|95.0|1.118|2.797||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.797|1.118|0.015
91658064|NCT03117569|183209869|NON_INFERIORITY|A total of 375 participants (2:1 randomisation) were planned for enrolment and evaluation as ITT population. Under the assumption that SVR12 rate would be 96% in both arms, the study had 80% power to show non-inferiority of the simplified monitoring strategy with a lower confidence bound for SVR12 in the simplified monitoring arm greater than 90% or with a lower confidence bound for the difference (simplified arm minus standard arm) in SVR12 greater than -6%.|Difference in Percentage of Participants|-3.2|||<|0.05|TWO_SIDED|95.0|-8.2|1.8|||t-test, 2 sided|||||1.8|-8.2|<0.05
91658065|NCT01030965|183209882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||<|0.001|TWO_SIDED|95.0|0.088|0.229|||Repeated Measures Analysis of Covariance|||||0.229|0.088|<0.001
91658066|NCT01030965|183209882|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.099|0.238|||Repeated Measures Analysis of Covariance|||||0.238|0.099|<0.001
91658067|NCT01030965|183209882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22|||Repeated Measures Analysis of Covariance|||||0.220|0.080|<0.001
91658068|NCT00824265|183209984|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.0032|TWO_SIDED|95.0|0.51|0.88|||Log Rank|||||0.88|0.51|0.0032
91658069|NCT00824265|183209985|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.1427|TWO_SIDED|95.0|0.59|1.09|||Log Rank|||||1.09|0.59|0.1427
91658070|NCT00824265|183209986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.449|TWO_SIDED|95.0|0.85|1.37|||Log Rank|||||1.37|0.85|0.4490
91658071|NCT00824265|183209987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0878|TWO_SIDED|95.0|0.56|1.05|||Log Rank|||||1.05|0.56|0.0878
91658072|NCT00824265|183209988|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0036|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.0036
91658073|NCT00824265|183209989|SUPERIORITY_OR_OTHER_LEGACY|Participants in the ITT population|Hazard Ratio (HR)|0.77||||0.1143|TWO_SIDED|95.0|0.55|1.08|||Log Rank|||||1.08|0.55|0.1143
91658074|NCT00824265|183209989|SUPERIORITY_OR_OTHER_LEGACY|Participants who took anti-cancer therapies|Hazard Ratio (HR)|0.67||||0.0109|TWO_SIDED|95.0|0.48|0.94|||Log Rank|||||0.94|0.48|0.0109
91658075|NCT00824265|183209992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
91658076|NCT00824265|183209993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||||||0.0166
91618364|NCT01332019|183129843|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 96||||<0.0001
91618365|NCT01332019|183129844|SUPERIORITY_OR_OTHER|||||||0.0012||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 48||||0.0012
91618366|NCT01332019|183129844|SUPERIORITY_OR_OTHER|||||||0.0026||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 96||||0.0026
91618367|NCT01332019|183129850|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.57||||0.006|TWO_SIDED|95.0|0.38|0.85||Based on Cox Proportional Hazards model, adjusted for 105MS302 baseline EDSS and age (\<40 vs \>=40).|Cox Proportional Hazards model||q2w/q4w|||0.85|0.38|0.0060
91618368|NCT00174785|183129873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.69|0.84||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason or death for the dronedarone group compared with the placebo group.|||0.84|0.69|<0.0001
91618369|NCT00174785|183129874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.18||95.0|0.66|1.08||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the dronedarone group compared with the placebo group.|||1.08|0.66|0.18
91618370|NCT00174785|183129875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.67|0.82||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason for the dronedarone group compared with the placebo group.|||0.82|0.67|<0.0001
91658077|NCT01402947|183210042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.013|||||TWO_SIDED|90.0|0.933|1.1|||ANOVA|||||1.100|0.933|
91658078|NCT01402947|183210043|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.999|||||TWO_SIDED|90.0|0.893|1.117|||ANOVA|||||1.117|0.893|
91658079|NCT02405195|183210065|OTHER|||||||0.638||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA throughout measurement period (before, during and after CPB).||||0.638
91658080|NCT02405195|183210066|OTHER|||||||0.972||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||0.972
91658081|NCT02405195|183210067|OTHER||||||<|0.001||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||<0.001
91658082|NCT02863575|183210071|SUPERIORITY||Least square (LS) means difference|2.68||||0.306|TWO_SIDED|95.0|-2.46|7.82|||ANCOVA|||||7.82|-2.46|0.306
91658083|NCT02863575|183210072|SUPERIORITY||LS mean difference|1.09||||0.056|TWO_SIDED|95.0|-0.03|2.2|||ANCOVA|||SPRID 0-2||2.20|-0.03|0.056
91658084|NCT02863575|183210072|SUPERIORITY||LS means difference|11.13|||<|0.001|TWO_SIDED|95.0|9.54|12.73|||ANCOVA|||SPRID 0-2||12.73|9.54|< 0.001
91658085|NCT02863575|183210072|SUPERIORITY||LS mean difference|10.05|||<|0.001|TWO_SIDED|95.0|8.45|11.64|||ANCOVA|||SPRID 0-2||11.64|8.45|< 0.001
91658086|NCT02863575|183210072|SUPERIORITY||LS mean difference|1.58||||0.177|TWO_SIDED|95.0|-0.72|3.87|||ANCOVA|||SPRID 0-4||3.87|-0.72|0.177
91658087|NCT02863575|183210072|SUPERIORITY||LS mean difference|24.04|||<|0.001|TWO_SIDED|95.0|20.76|27.32|||ANCOVA|||SPRID 0-4||27.32|20.76|< 0.001
91658088|NCT02863575|183210072|SUPERIORITY||LS mean difference|22.46|||<|0.001|TWO_SIDED|95.0|19.18|25.75|||ANCOVA|||SPRID 0-4||25.75|19.18|< 0.001
91658089|NCT02863575|183210072|SUPERIORITY||LS mean difference|2.39||||0.201|TWO_SIDED|95.0|-1.28|6.06|||ANCOVA|||SPRID 0-6||6.06|-1.28|0.201
91658090|NCT02863575|183210072|SUPERIORITY||LS mean difference|34.3|||<|0.001|TWO_SIDED|95.0|29.06|39.55|||ANCOVA|||SPRID 0-6||39.55|29.06|< 0.001
91658091|NCT02863575|183210072|SUPERIORITY||LS mean difference|31.91|||<|0.001|TWO_SIDED|95.0|26.67|37.16|||ANCOVA|||SPRID 0-6||37.16|26.67|< 0.001
91658092|NCT02863575|183210072|SUPERIORITY||LS mean difference|40.85|||<|0.001|TWO_SIDED|95.0|33.49|48.2|||ANCOVA|||SPRID 0-8||48.20|33.49|< 0.001
91658093|NCT02863575|183210072|SUPERIORITY||LS mean difference|38.17|||<|0.001|TWO_SIDED|95.0|30.81|45.52|||ANCOVA|||SPRID 0-8||45.52|30.81|< 0.001
91524546|NCT02799472|182923984|OTHER||Mean Difference (Net)|1435.3||||0.6|TWO_SIDED|95.0|-4101.4|6972.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 12||6972.0|-4101.4|0.600
91524547|NCT02799472|182923984|OTHER||Mean Difference (Net)|-1210.2||||0.534|TWO_SIDED|95.0|-5213.1|2792.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, 12-Week FU||2792.7|-5213.1|0.534
91618371|NCT00174785|183129876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.025||95.0|0.51|0.96||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of cardiovascular death for the dronedarone group compared with the placebo group.|||0.96|0.51|0.025
91618372|NCT00174785|183129877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.03||95.0|0.51|0.98||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The comparison was performed at the 5% level using a 2-sided Log rank|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of adjudicated cardiovascular death for the dronedarone group compared with the placebo group.|||0.98|0.51|0.03
91618373|NCT00120289|183129878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|95.0|0.87|1.21|||Regression, Cox|Adjusting for gender and history of diabetes (randomization stratification factors).||||1.21|0.87|0.80
91618374|NCT00120289|183129879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.49|TWO_SIDED|95.0|0.87|1.34|||Regression, Cox|||||1.34|0.87|.49
91618375|NCT00120289|183129880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.9|1.42|||Regression, Cox|||||1.42|0.90|.30
91618376|NCT00120289|183129881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.8|||Regression, Cox|||||1.80|0.76|0.47
91618377|NCT00401622|183129883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|7.51||0.31|TWO_SIDED|95.0|-7.24|22.36|||t-test, 2 sided|||||22.36|-7.24|0.31
91618378|NCT00401622|183129884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.45|TWO_SIDED|95.0|-0.38|0.04|||ANCOVA|Visit 1 A1c measurement used as the covariate||Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS||0.04|-0.38|0.45
91618379|NCT00782418|183129897|SUPERIORITY_OR_OTHER||Least Squares Mean|1.6|||<|0.001||90.0|1.29|1.92||1-sided, alpha=0.05|ANOVA|||||1.92|1.29|<0.001
91618380|NCT00782418|183129897|SUPERIORITY_OR_OTHER||Least Squares Mean|0.95|||<|0.001||90.0|0.66|1.24|||ANOVA|1-sided, alpha=0.05||||1.24|0.66|<0.001
91618381|NCT00782418|183129897|SUPERIORITY_OR_OTHER||Least Squares Mean|2.32|||<|0.001||90.0|1.57|3.06|||ANOVA|1-sided, alpha=0.05||||3.06|1.57|<0.001
91524548|NCT02799472|182923985|OTHER||Mean Difference (Net)|2756.3||||0.328|TWO_SIDED|95.0|-2953.7|8466.3|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 1||8466.3|-2953.7|0.328
91618382|NCT00782418|183129897|SUPERIORITY_OR_OTHER||Least Squares Mean|1.38|||<|0.001||90.0|0.64|2.12|||ANOVA|1-sided, alpha = 0.05||||2.12|0.64|<0.001
91524549|NCT02799472|182923985|OTHER||Mean Difference (Net)|-487.5||||0.895|TWO_SIDED|95.0|-8003.7|7028.6|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 4||7028.6|-8003.7|0.895
91524550|NCT02799472|182923985|OTHER||Mean Difference (Net)|-277.4||||0.961|TWO_SIDED|95.0|-12001.0|11446.2|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 12||11446.2|-12001.0|0.961
91524551|NCT02799472|182923985|OTHER||Mean Difference (Net)|-311.6||||0.956|TWO_SIDED|95.0|-11960.5|11337.4|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, 12-Week FU||11337.4|-11960.5|0.956
91524552|NCT02799472|182923985|OTHER||Mean Difference (Net)|6866.9||||0.212|TWO_SIDED|95.0|-4230.7|17964.6|||Repeated measures analysis|||CD14br+CD16+, Week 1||17964.6|-4230.7|0.212
91618383|NCT00782418|183129898|SUPERIORITY_OR_OTHER||Least Squares Mean|23.1|||<|0.001||90.0|19.2|27.0|||ANOVA|1-side, alpha = 0.05||||27.0|19.2|<0.001
91618384|NCT00782418|183129898|SUPERIORITY_OR_OTHER||Least Squares Mean|16.4|||<|0.001||90.0|12.6|20.1|||ANOVA|1-side, alpha = 0.05||||20.1|12.6|<0.001
91618385|NCT00782418|183129899|SUPERIORITY_OR_OTHER||Least Squares Mean|545.0|||<|0.001||90.0|451.4|638.7|||ANOVA|1-side, alpha = 0.05||||638.7|451.4|<0.001
91618386|NCT00782418|183129899|SUPERIORITY_OR_OTHER||Least Squares Mean|246.6|||<|0.001||90.0|160.9|323.3|||ANOVA|1-side, alpha = 0.05||||323.3|160.9|<0.001
91618387|NCT01718509|183129900|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-2.04|-1.28|||Mixed Models Repeated Measures Analysis|||||-1.28|-2.04|<0.001
91618388|NCT01718509|183129901|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
91618389|NCT01718509|183129902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
91618390|NCT01718509|183129903|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-5.41|||<|0.001|TWO_SIDED|95.0|-6.39|-4.44|||Mixed Models Repeated Measures Analysis|||||-4.44|-6.39|<0.001
91618391|NCT01718509|183129904|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.94|||<|0.001|TWO_SIDED|95.0|-9.51|-6.36|||Mixed Models Repeated Measures Analysis|||||-6.36|-9.51|<0.001
91618392|NCT01718509|183129905|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.196||||0.002|TWO_SIDED|95.0|-0.321|-0.07|||ANCOVA|||||-0.070|-0.321|0.002
91618393|NCT01718509|183129906|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.077||||0.234|TWO_SIDED|95.0|-0.205|0.05|||ANCOVA|||||0.050|-0.205|0.234
91618394|NCT01718509|183129907|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.03||||0.185|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA|||||0.08|-0.02|0.185
91618395|NCT01718509|183129908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
91618396|NCT01718509|183129909|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.77|-1.69||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.69|-2.77|<0.001
91712911|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.01|||||TWO_SIDED|95.0|0.53|1.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.93|0.53|
91712912|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|2.87|||||TWO_SIDED|95.0|1.51|5.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.47|1.51|
91712913|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|4.98|||||TWO_SIDED|95.0|2.62|9.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.48|2.62|
91712914|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|3.39|||||TWO_SIDED|95.0|1.78|6.44|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||6.44|1.78|
91712915|NCT03311841|183317584|OTHER|Comparison of pitavastatin|Geometric least squares mean ratio|1.32|||||TWO_SIDED|95.0|0.76|2.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.31|0.76|
91712916|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.96|||||TWO_SIDED|95.0|1.12|3.42|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.42|1.12|
91618397|NCT01718509|183129910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.27||||0.011|TWO_SIDED|95.0|0.29|2.24||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.24|0.29|0.011
91618398|NCT01718509|183129910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.44|-2.76||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-2.76|-4.44|<0.001
91618399|NCT01718509|183129910|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.21|||<|0.001|TWO_SIDED|95.0|-5.09|-3.33||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.33|-5.09|<0.001
91618400|NCT01718509|183129911|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-9.28|||<|0.001|TWO_SIDED|95.0|-11.44|-7.12||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-7.12|-11.44|<0.001
91618401|NCT01718509|183129912|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.96||||0.298|TWO_SIDED|95.0|-2.77|0.85||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||0.85|-2.77|0.298
91618402|NCT00779324|183129957|OTHER||Difference in percents|-0.4||||0.9554|TWO_SIDED|95.0|-14.7|13.9|||Chi-squared|||||13.9|-14.7|0.9554
91618403|NCT00779324|183129958|OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91618404|NCT00779324|183129959|OTHER||Difference in percents|10.8||||0.1662|TWO_SIDED|95.0|-4.2|25.8|||Chi-squared|||||25.8|-4.2|0.1662
91618405|NCT00779324|183129960|OTHER|||||||0.3488|||||||Wilcoxon (Mann-Whitney)|||||||0.3488
91618406|NCT00779324|183129962|OTHER||Difference in percents|6.4||||0.38|TWO_SIDED|95.0|-7.2|20.0|||Chi-squared|||||20|-7.2|0.38
91618407|NCT00779324|183129963|OTHER||Difference in percents|11.7||||0.1373|TWO_SIDED|95.0|-3.3|26.7|||Chi-squared|||||26.7|-3.3|0.1373
91618408|NCT00779324|183129964|OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91618409|NCT00779324|183129965|OTHER|||||||0.0353|||||||Wilcoxon (Mann-Whitney)|||||||0.0353
91618410|NCT00194025|183129978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
91618411|NCT00194025|183129979|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.585
91618412|NCT00194025|183129980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
91618413|NCT00194025|183129981|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.017
91618414|NCT00194025|183129982|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.027
91618415|NCT00194025|183129983|SUPERIORITY_OR_OTHER|||||||0.569||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.569
91618416|NCT00194025|183129984|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.038
91618417|NCT00194025|183129985|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.199
91618418|NCT00194025|183129986|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||The t-test was applied to the values at baseline vs. the values at 12 weeks.||||0.21
91618419|NCT00511342|183130007|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.078||||0.19|TWO_SIDED|95.0|-0.198|0.041||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for lumbar spine (L2-L4)|||0.041|-0.198|0.19
91618420|NCT00511342|183130007|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.03||||0.57|TWO_SIDED|95.0|-0.136|0.075||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for femoral neck|||0.075|-0.136|0.57
91618421|NCT02196038|183130059|SUPERIORITY||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.9|2.0|||joint model|Joint model of ANCOVA plus survival||||2.0|0.9|<0.0001
91618422|NCT02196038|183130060|SUPERIORITY||Rate Ratio|0.93||||0.59|TWO_SIDED|95.0|0.66|1.19|||Joint Model|Joint model of Poisson regression and survival||||1.19|0.66|0.59
91618423|NCT01580592|183130085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_DEVIATION|7.6||0.001|TWO_SIDED||||||ANOVA||for omalizumab 150mg|||||0.001
91618424|NCT01580592|183130085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|9.4||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91618425|NCT01580592|183130085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.9|||TWO_SIDED|||||||||||||
91618426|NCT01580592|183130086|SUPERIORITY_OR_OTHER|||||||0.988|||||||Chi-squared|||||||0.988
91618427|NCT02402218|183130135|SUPERIORITY|||||||0.11||||||For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.|Chi-squared|||Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.||||.11
91618428|NCT02402218|183130136|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||.22
91618429|NCT02402218|183130138|SUPERIORITY|||||||0.33|||||||Chi-squared|||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.||||0.33
91618430|NCT02402218|183130139|SUPERIORITY|||||||0.3||||||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|Chi-squared|||||||0.30
91618431|NCT04436822|183130146|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.9|||<|0.05|TWO_SIDED|90.0|87.1|90.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||90.7|87.1|<0.05
91618432|NCT04436822|183130146|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.5|||<|0.05|TWO_SIDED|90.0|85.4|89.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.7|85.4|<0.05
91618433|NCT04436822|183130146|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.9|||<|0.05|TWO_SIDED|90.0|85.8|89.9|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.9|85.8|<0.05
91618434|NCT03807739|183130147|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2471|||||TWO_SIDED|90.0|1.1149|1.3951||||||||1.3951|1.1149|
91658094|NCT02863575|183210073|SUPERIORITY||LS means difference|0.73||||0.066|TWO_SIDED|95.0|-0.05|1.5|||ANCOVA|||SPID 0-2||1.50|-0.05|0.066
91712917|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.73|2.13|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.13|0.73|
91618435|NCT03807739|183130147|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9864|||||TWO_SIDED|90.0|0.8531|1.1405||||||||1.1405|0.8531|
91618436|NCT03807739|183130149|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2203|||||TWO_SIDED|90.0|1.1175|1.3327||||||||1.3327|1.1175|
91618437|NCT03807739|183130149|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9947|||||TWO_SIDED|90.0|0.8266|1.1968||||||||1.1968|0.8266|
91618438|NCT00430625|183130150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.429|STANDARD_ERROR_OF_MEAN|0.324|<|0.0001|TWO_SIDED|95.0|1.717|3.141|||paired t-test|||Primary endpoint was based solely on the 60 U/kg treatment arm||3.141|1.717|<0.0001
91658095|NCT02863575|183210073|SUPERIORITY||LS means difference|7.55|||<|0.001|TWO_SIDED|95.0|6.44|8.66|||ANCOVA|||SPID 0-2||8.66|6.44|< 0.001
91712918|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.74|2.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.27|0.74|
91712919|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.05|||||TWO_SIDED|95.0|0.64|1.72|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.72|0.64|
91712920|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.88|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.38|0.88|
91658096|NCT02863575|183210073|SUPERIORITY||LS means difference|6.82|||<|0.001|TWO_SIDED|95.0|5.71|7.93|||ANCOVA|||SPID 0-2||7.93|5.71|< 0.001
91712921|NCT03311841|183317584|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.68|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.76|0.68|
91712922|NCT03311841|183317584|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.43|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.17|0.43|
91712923|NCT03311841|183317584|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.53|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.41|0.53|
91712924|NCT03311841|183317584|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.89|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.46|0.89|
91524553|NCT02799472|182923985|OTHER||Mean Difference (Net)|8359.6||||0.227|TWO_SIDED|95.0|-5533.3|22252.5|||Repeated measures analysis|||CD14br+CD16+, Week 4||22252.5|-5533.3|0.227
91658097|NCT02863575|183210073|SUPERIORITY||LS means difference|1.14||||0.165|TWO_SIDED|95.0|-0.47|2.74|||ANCOVA|||SPID 0-4||2.74|-0.47|0.165
91658098|NCT02863575|183210073|SUPERIORITY||LS means difference|16.35|||<|0.001|TWO_SIDED|95.0|14.05|18.64|||ANCOVA|||SPID 0-4||18.64|14.05|< 0.001
91658099|NCT02863575|183210073|SUPERIORITY||LS means difference|15.21|||<|0.001|TWO_SIDED|95.0|12.91|17.51|||ANCOVA|||SPID 0-4||17.51|12.91|< 0.001
91618439|NCT00125658|183130161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.||||<.001
91618440|NCT00125658|183130161|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.||||.002
91658100|NCT02863575|183210073|SUPERIORITY||LS means difference|1.78||||0.172|TWO_SIDED|95.0|-0.78|4.34|||ANCOVA|||SPID 0-6||4.34|-0.78|0.172
91524554|NCT02799472|182923985|OTHER||Mean Difference (Net)|-22683.6||||0.04|TWO_SIDED|95.0|-44298.5|-1068.8|||Repeated measures analysis|||CD14br+CD16+, Week 12||-1068.8|-44298.5|0.040
91524555|NCT02799472|182923985|OTHER||Mean Difference (Net)|-3757.2||||0.741|TWO_SIDED|95.0|-27146.0|19631.6|||Repeated measures analysis|||CD14br+CD16+, 12-Week FU||19631.6|-27146.0|0.741
91658101|NCT02863575|183210073|SUPERIORITY||LS means difference|23.37|||<|0.001|TWO_SIDED|95.0|19.71|27.03|||ANCOVA|||SPID 0-6||27.03|19.71|< 0.001
91658102|NCT02863575|183210073|SUPERIORITY||LS means difference|21.59|||<|0.001|TWO_SIDED|95.0|17.93|25.25|||ANCOVA|||SPID 0-6||25.25|17.93|< 0.001
91658103|NCT02863575|183210073|SUPERIORITY||LS means difference|2.1||||0.249|TWO_SIDED|95.0|-1.47|5.67|||ANCOVA|||SPID 0-8||5.67|-1.47|0.249
91658104|NCT02863575|183210073|SUPERIORITY||LS means difference|27.88|||<|0.001|TWO_SIDED|95.0|22.78|32.99|||ANCOVA|||SPID 0-8||32.99|22.78|< 0.001
91658105|NCT02863575|183210073|SUPERIORITY||LS means difference|25.79|||<|0.001|TWO_SIDED|95.0|20.68|30.89|||ANCOVA|||SPID 0-8||30.89|20.68|< 0.001
91658106|NCT02863575|183210074|SUPERIORITY||LS means difference|0.36||||0.044|TWO_SIDED|95.0|0.01|0.71|||ANCOVA|||TOTPAR 0-2||0.71|0.01|0.044
91658107|NCT02863575|183210074|SUPERIORITY||LS means difference|3.59|||<|0.001|TWO_SIDED|95.0|3.09|4.09|||ANCOVA|||TOTPAR 0-2||4.09|3.09|< 0.001
91712925|NCT03311841|183317584|OTHER||Geometric least squares mean ratio|1.63|||||TWO_SIDED|95.0|0.85|3.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.14|0.85|
91712926|NCT03311841|183317584|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.57|2.22|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.22|0.57|
91618441|NCT00125658|183130162|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).||||0.13
91712927|NCT03311841|183317584|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.38|||||TWO_SIDED|95.0|0.76|2.49|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.49|0.76|
91712928|NCT03311841|183317584|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.75|2.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.29|0.75|
91712929|NCT03311841|183317584|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.65|1.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.81|0.65|
91524556|NCT02799472|182923985|OTHER||Mean Difference (Net)|-22417.0||||0.628|TWO_SIDED|95.0|-116677.8|71843.8|||Repeated measures analysis|||CD14br+CD16-, Week 1||71843.8|-116677.8|0.628
91524557|NCT02799472|182923985|OTHER||Mean Difference (Net)|27659.7||||0.321|TWO_SIDED|95.0|-28567.8|83887.1|||Repeated measures analysis|||CD14br+CD16-, Week 4||83887.1|-28567.8|0.321
91712930|NCT03311841|183317584|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|0.79|||||TWO_SIDED|95.0|0.46|1.33|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.33|0.46|
91712931|NCT03311841|183317584|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.9|||||TWO_SIDED|95.0|0.33|2.45|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.45|0.33|
91524558|NCT02799472|182923985|OTHER||Mean Difference (Net)|16182.9||||0.704|TWO_SIDED|95.0|-70377.0|102742.9|||Repeated measures analysis|||CD14br+CD16-, Week 12||102742.9|-70377.0|0.704
91524559|NCT02799472|182923985|OTHER||Mean Difference (Net)|-63419.4||||0.232|TWO_SIDED|95.0|-170364.9|43526.1|||Repeated measures analysis|||CD14br+CD16-, 12-Week FU||43526.1|-170364.9|0.232
91524560|NCT02799472|182923985|OTHER||Mean Difference (Net)|-6913.6||||0.366|TWO_SIDED|95.0|-22588.4|8761.1|||Repeated measures analysis|||CD14lo+CD16br+, Week 1||8761.1|-22588.4|0.366
91618442|NCT00125658|183130162|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.||||0.048
91618443|NCT00125658|183130163|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.||||.004
91658108|NCT02863575|183210074|SUPERIORITY||LS means difference|3.23|||<|0.001|TWO_SIDED|95.0|2.73|3.73|||ANCOVA|||TOTPAR 0-2||3.73|2.73|< 0.001
91791561|NCT03274999|183460931|SUPERIORITY|||||||0.005||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.005
91791562|NCT03274999|183460931|SUPERIORITY|||||||0.089||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.089
91791563|NCT03274999|183460931|SUPERIORITY|||||||0.112||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.112
91791564|NCT03274999|183460931|SUPERIORITY|||||||0.16||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.16
91791565|NCT03274999|183460931|SUPERIORITY|||||||0.077||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.077
91791566|NCT03274999|183460931|SUPERIORITY|||||||0.157||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.157
91791567|NCT03274999|183460931|SUPERIORITY|||||||0.111||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.111
91524561|NCT02799472|182923985|OTHER||Mean Difference (Net)|-2231.6||||0.603|TWO_SIDED|95.0|-10976.8|6513.6|||Repeated measures analysis|||CD14lo+CD16br+, Week 4||6513.6|-10976.8|0.603
91658109|NCT02863575|183210074|SUPERIORITY||LS means difference|0.44||||0.224|TWO_SIDED|95.0|-0.27|1.15|||ANCOVA|||TOTPAR 0-4||1.15|-0.27|0.224
91791568|NCT03274999|183460931|SUPERIORITY|||||||0.04||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.040
91791569|NCT03274999|183460931|SUPERIORITY|||||||0.241||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.241
91791570|NCT03274999|183460931|SUPERIORITY|||||||0.284||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.284
91791571|NCT03274999|183460931|SUPERIORITY|||||||0.313||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.313
91791572|NCT03274999|183460931|SUPERIORITY|||||||0.433||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.433
91791573|NCT03274999|183460931|SUPERIORITY|||||||0.406||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.406
91524562|NCT02799472|182923985|OTHER||Mean Difference (Net)|-10179.1||||0.084|TWO_SIDED|95.0|-21827.4|1469.2|||Repeated measures analysis|||CD14lo+CD16br+, Week 12||1469.2|-21827.4|0.084
91524563|NCT02799472|182923985|OTHER||Mean Difference (Net)|-20744.2||||0.026|TWO_SIDED|95.0|-38771.8|-2716.5|||Repeated measures analysis|||CD14lo+CD16br+, 12-Week FU||-2716.5|-38771.8|0.026
91658110|NCT02863575|183210074|SUPERIORITY||LS means difference|7.69|||<|0.001|TWO_SIDED|95.0|6.68|8.71|||ANCOVA|||TOTPAR 0-4||8.71|6.68|< 0.001
91658111|NCT02863575|183210074|SUPERIORITY||LS means difference|7.25|||<|0.001|TWO_SIDED|95.0|6.23|8.27|||ANCOVA|||TOTPAR 0-4||8.27|6.23|< 0.001
91658112|NCT02863575|183210074|SUPERIORITY||LS means difference|0.61||||0.293|TWO_SIDED|95.0|-0.53|1.75|||ANCOVA|||TOTPAR 0-6||1.75|-0.53|0.293
91658113|NCT02863575|183210074|SUPERIORITY||LS means difference|10.93|||<|0.001|TWO_SIDED|95.0|9.3|12.56|||ANCOVA|||TOTPAR 0-6||12.56|9.30|< 0.001
91658114|NCT02863575|183210074|SUPERIORITY||LS means difference|10.32|||<|0.001|TWO_SIDED|95.0|8.69|11.95|||ANCOVA|||TOTPAR 0-6||11.95|8.69|< 0.001
91658115|NCT02863575|183210074|SUPERIORITY||LS means difference|0.58||||0.476|TWO_SIDED|95.0|-1.03|2.19|||ANCOVA|||TOTPAR 0-8||2.19|-1.03|0.476
91658116|NCT02863575|183210074|SUPERIORITY||LS means difference|12.96|||<|0.001|TWO_SIDED|95.0|10.66|15.26|||ANCOVA|||TOTPAR 0-8||15.26|10.66|< 0.001
91658117|NCT02863575|183210074|SUPERIORITY||LS means difference|12.38|||<|0.001|TWO_SIDED|95.0|10.08|14.68|||ANCOVA|||TOTPAR 0-8||14.68|10.08|< 0.001
91658118|NCT02863575|183210075|SUPERIORITY||LS means difference|0.01||||0.975|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||PRID at 0.25 hour||0.36|-0.35|0.975
91618444|NCT00125658|183130163|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.||||0.034
91658119|NCT02863575|183210075|SUPERIORITY||LS means difference|0.12||||0.654|TWO_SIDED|95.0|-0.4|0.63|||ANCOVA|||PRID at 0.25 hour||0.63|-0.40|0.654
91658120|NCT02863575|183210075|SUPERIORITY||LS means difference|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.62|||ANCOVA|||PRID at 0.25 hour||0.62|-0.40|0.670
91658121|NCT02863575|183210075|SUPERIORITY||LS means difference|-0.04||||0.917|TWO_SIDED|95.0|-0.7|0.63|||ANCOVA|||PRID at 0.5 hour||0.63|-0.70|0.917
91618445|NCT00125658|183130164|SUPERIORITY_OR_OTHER|||||||0.056|||||||t-test, 2 sided|||Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.||||0.056
91618446|NCT00125658|183130164|SUPERIORITY_OR_OTHER|||||||0.168|||||||t-test, 2 sided|||Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.||||.168
91658122|NCT02863575|183210075|SUPERIORITY||LS means difference|2.26|||<|0.001|TWO_SIDED|95.0|1.31|3.2|||ANCOVA|||PRID at 0.5 hour||3.20|1.31|< 0.001
91658123|NCT02863575|183210075|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.35|3.24|||ANCOVA|||PRID at 0.5 hour||3.24|1.35|< 0.001
91658124|NCT02863575|183210075|SUPERIORITY||LS means difference|0.73||||0.039|TWO_SIDED|95.0|0.04|1.42|||ANCOVA|||PRID at 1 hour||1.42|0.04|0.039
91658125|NCT02863575|183210075|SUPERIORITY||LS means difference|6.11|||<|0.001|TWO_SIDED|95.0|5.12|7.1|||ANCOVA|||PRID at 1 hour||7.10|5.12|< 0.001
91618447|NCT00125658|183130165|SUPERIORITY_OR_OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.||||0.564
91618448|NCT00125658|183130165|SUPERIORITY_OR_OTHER|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.||||0.948
91618449|NCT00125658|183130166|SUPERIORITY_OR_OTHER|||||||0.078|||||||t-test, 2 sided|||Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.||||0.078
91658126|NCT02863575|183210075|SUPERIORITY||LS means difference|5.38|||<|0.001|TWO_SIDED|95.0|4.39|6.37|||ANCOVA|||PRID at 1 hour||6.37|4.39|< 0.001
91658127|NCT02863575|183210075|SUPERIORITY||LS means difference|0.84||||0.015|TWO_SIDED|95.0|0.16|1.52|||ANCOVA|||PRID at 1.5 hour||1.52|0.16|0.015
91658128|NCT02863575|183210075|SUPERIORITY||LS means difference|7.36|||<|0.001|TWO_SIDED|95.0|6.39|8.33|||ANCOVA|||PRID at 1.5 hour||8.33|6.39|< 0.001
91524564|NCT02799472|182923986|OTHER||Mean Difference (Net)|178.2||||0.564|TWO_SIDED|95.0|-448.3|804.6|||Repeated measures analysis|||Week 1||804.6|-448.3|0.564
91618450|NCT00125658|183130166|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||Tests the effect of treatment order (Order A (FTP \> POWER) vs. Order B (POWER \> FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.||||0.4
91658129|NCT02863575|183210075|SUPERIORITY||LS means difference|6.52|||<|0.001|TWO_SIDED|95.0|5.55|7.49|||ANCOVA|||PRID at 1.5 hour||7.49|5.55|< 0.001
91658130|NCT02863575|183210075|SUPERIORITY||LS means difference|0.62||||0.071|TWO_SIDED|95.0|-0.05|1.3|||ANCOVA|||PRID at 2 hour||1.30|-0.05|0.071
91658131|NCT02863575|183210075|SUPERIORITY||LS means difference|7.62|||<|0.001|TWO_SIDED|95.0|6.65|8.58|||ANCOVA|||PRID at 2 hour||8.58|6.65|< 0.001
91618451|NCT00125658|183130167|SUPERIORITY_OR_OTHER|||||||0.085|||||||t-test, 2 sided|||Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.||||0.085
91658132|NCT02863575|183210075|SUPERIORITY||LS means difference|6.99|||<|0.001|TWO_SIDED|95.0|6.03|7.96|||ANCOVA|||PRID at 2 hour||7.96|6.03|< 0.001
91658133|NCT02863575|183210075|SUPERIORITY||LS means difference|0.41||||0.243|TWO_SIDED|95.0|-0.28|1.09|||ANCOVA|||PRID at 3 hour||1.09|-0.28|0.243
91658134|NCT02863575|183210075|SUPERIORITY||LS means difference|6.83|||<|0.001|TWO_SIDED|95.0|5.85|7.8|||ANCOVA|||PRID at 3 hour||7.80|5.85|< 0.001
91658135|NCT02863575|183210075|SUPERIORITY||LS means difference|6.42|||<|0.001|TWO_SIDED|95.0|5.44|7.4|||ANCOVA|||PRID at 3 hour||7.40|5.44|< 0.001
91658136|NCT02863575|183210075|SUPERIORITY||LS means difference|0.08||||0.823|TWO_SIDED|95.0|-0.65|0.82|||ANCOVA|||PRID at 4 hour||0.82|-0.65|0.823
91658137|NCT02863575|183210075|SUPERIORITY||LS means difference|6.08|||<|0.001|TWO_SIDED|95.0|5.02|7.14|||ANCOVA|||PRID at 4 hour||7.14|5.02|< 0.001
91658138|NCT02863575|183210075|SUPERIORITY||LS means difference|6.0|||<|0.001|TWO_SIDED|95.0|4.94|7.05|||ANCOVA|||PRID at 4 hour||7.05|4.94|< 0.001
91658139|NCT02863575|183210075|SUPERIORITY||LS means difference|0.31||||0.438|TWO_SIDED|95.0|-0.48|1.11|||ANCOVA|||PRID at 5 hour||1.11|-0.48|0.438
91712932|NCT03311841|183317584|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|0.75|5.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||5.14|0.75|
91712933|NCT03311841|183317584|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.49|3.16|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.16|0.49|
91524565|NCT02799472|182923986|OTHER||Mean Difference (Net)|540.4||||0.216|TWO_SIDED|95.0|-335.7|1416.5|||Repeated measures analysis|||Week 4||1416.5|-335.7|0.216
91524566|NCT02799472|182923986|OTHER||Mean Difference (Net)|-252.6||||0.629|TWO_SIDED|95.0|-1326.0|820.8|||Repeated measures analysis|||Week 12||820.8|-1326.0|0.629
91524567|NCT02799472|182923986|OTHER||Mean Difference (Net)|41.6||||0.932|TWO_SIDED|95.0|-962.2|1045.5|||Repeated measures analysis|||12-Week FU||1045.5|-962.2|0.932
91618452|NCT00125658|183130167|SUPERIORITY_OR_OTHER|||||||0.635|||||||t-test, 2 sided|||Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.||||0.635
91618453|NCT00369668|183130190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|22.5|37.4|||Mixed Models Analysis|Greenhouse-Geisser degrees of freedom adjustment was not necessary.||Group by Test Session ANOVA with repeated measures on second factor.||37.4|22.5|<0.05
91618454|NCT03855137|183130201|SUPERIORITY||Least Squares Mean Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.48|-1.33||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Mixed Model Repeated Measures (MMRM)||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.33|-3.48|0.0001
91618455|NCT03855137|183130201|SUPERIORITY||Least Squares Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.545||0.0009|TWO_SIDED|95.0|-2.89|-0.75||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.75|-2.89|0.0009
91618456|NCT03855137|183130202|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.31|-1.16||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.16|-3.31|0.0001
91618457|NCT03855137|183130202|SUPERIORITY||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.544||0.0024|TWO_SIDED|95.0|-2.72|-0.59|||MMRM|Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.59|-2.72|0.0024
91658140|NCT02863575|183210075|SUPERIORITY||LS means difference|5.47|||<|0.001|TWO_SIDED|95.0|4.33|6.6|||ANCOVA|||PRID at 5 hour||6.60|4.33|< 0.001
91658141|NCT02863575|183210075|SUPERIORITY||LS means difference|5.15|||<|0.001|TWO_SIDED|95.0|4.01|6.29|||ANCOVA|||PRID at 5 hour||6.29|4.01|< 0.001
91524568|NCT02799472|182923994|OTHER||Median Difference (Net)|-0.13||||0.547|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \<0||2.23|-2.32|0.547
91658142|NCT02863575|183210075|SUPERIORITY||LS means difference|0.5||||0.25|TWO_SIDED|95.0|-0.35|1.35|||ANCOVA|||PRID at 6 hour||1.35|-0.35|0.250
91658143|NCT02863575|183210075|SUPERIORITY||LS means difference|4.8|||<|0.001|TWO_SIDED|95.0|3.58|6.02|||ANCOVA|||PRID at 6 hour||6.02|3.58|< 0.001
91658144|NCT02863575|183210075|SUPERIORITY||LS means difference|4.3|||<|0.001|TWO_SIDED|95.0|3.08|5.52|||ANCOVA|||PRID at 6 hour||5.52|3.08|< 0.001
91618458|NCT03855137|183130203|SUPERIORITY||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.541||0.0001|TWO_SIDED|95.0|-3.38|-1.26||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.26|-3.38|0.0001
91618459|NCT03855137|183130203|SUPERIORITY||Least Squares Mean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.538||0.0009|TWO_SIDED|95.0|-2.93|-0.81||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.81|-2.93|0.0009
91618460|NCT03855137|183130204|SUPERIORITY||Least Squares Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|0.539||0.0002|TWO_SIDED|95.0|-3.2|-1.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.09|-3.20|0.0002
91658145|NCT02863575|183210075|SUPERIORITY||LS means difference|0.11||||0.818|TWO_SIDED|95.0|-0.8|1.01|||ANCOVA|||PRID at 7 hour||1.01|-0.80|0.818
91658146|NCT02863575|183210075|SUPERIORITY||LS means difference|3.53|||<|0.001|TWO_SIDED|95.0|2.23|4.82|||ANCOVA|||PRID at 7 hour||4.82|2.23|< 0.001
91658147|NCT02863575|183210075|SUPERIORITY||LS means difference|3.42|||<|0.001|TWO_SIDED|95.0|2.12|4.71|||ANCOVA|||PRID at 7 hour||4.71|2.12|< 0.001
91658148|NCT02863575|183210075|SUPERIORITY||LS means difference|0.18||||0.698|TWO_SIDED|95.0|-0.74|1.11|||ANCOVA|||PRID at 8 hour||1.11|-0.74|0.698
91658149|NCT02863575|183210075|SUPERIORITY||LS means difference|3.02|||<|0.001|TWO_SIDED|95.0|1.69|4.34|||ANCOVA|||PRID at 8 hour||4.34|1.69|< 0.001
91658150|NCT02863575|183210075|SUPERIORITY||LS means difference|2.83|||<|0.001|TWO_SIDED|95.0|1.51|4.16|||ANCOVA|||PRID at 8 hour||4.16|1.51|< 0.001
91658151|NCT02863575|183210076|SUPERIORITY||LS means difference|0.04||||0.575|TWO_SIDED|94.0|-0.09|0.16|||ANCOVA|||PRR score at 0.25 hour||0.16|-0.09|0.575
91658152|NCT02863575|183210076|SUPERIORITY||LS means difference|0.07||||0.426|TWO_SIDED|95.0|-0.11|0.25|||ANCOVA|||PRR score at 0.25 hour||0.25|-0.11|0.426
91618461|NCT03855137|183130204|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.536||0.0024|TWO_SIDED|95.0|-2.78|-0.67||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.67|-2.78|0.0024
91524569|NCT02799472|182923994|OTHER||Median Difference (Net)|-2.18||||0.948|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \<0||0.51|-4.77|0.948
91618462|NCT03855137|183130205|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-3.63|-1.63||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.63|-3.63|0.0001
91791574|NCT03274999|183460931|SUPERIORITY|||||||0.318||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
91524570|NCT02799472|182923994|OTHER||Median Difference (Net)|-2.28||||0.949|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \<0||0.45|-5.02|0.949
91524571|NCT02799472|182923994|OTHER||Median Difference (Net)|-0.13||||0.453|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \>0||2.23|-2.32|0.453
91791575|NCT03274999|183460931|SUPERIORITY|||||||0.499||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.499
91658153|NCT02863575|183210076|SUPERIORITY||LS means difference|0.04||||0.686|TWO_SIDED|95.0|-0.14|0.22|||ANCOVA|||PRR score at 0.25 hour||0.22|-0.14|0.686
91658154|NCT02863575|183210076|SUPERIORITY||LS means difference|0.07||||0.543|TWO_SIDED|95.0|-0.15|0.29|||ANCOVA|||PRR score at 0.5 hour||0.29|-0.15|0.543
91618463|NCT03855137|183130205|SUPERIORITY||Least Squares Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.508||0.0009|TWO_SIDED|95.0|-3.13|-1.13||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.13|-3.13|0.0009
91618464|NCT03855137|183130206|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|0.507||0.0002|TWO_SIDED|95.0|-3.52|-1.53||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.53|-3.52|0.0002
91618465|NCT03855137|183130206|SUPERIORITY||Least Squares Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.505||0.0024|TWO_SIDED|95.0|-3.09|-1.1|||MMRM|||||-1.10|-3.09|0.0024
91658155|NCT02863575|183210076|SUPERIORITY||LS means difference|0.81|||<|0.001|TWO_SIDED|95.0|0.49|1.12|||ANCOVA|||PRR score at 0.5 hour||1.12|0.49|< 0.001
91658156|NCT02863575|183210076|SUPERIORITY||LS means difference|0.74|||<|0.001|TWO_SIDED|95.0|0.42|1.05|||ANCOVA|||PRR score at 0.5 hour||1.05|0.42|< 0.001
91658157|NCT02863575|183210076|SUPERIORITY||LS means difference|0.24||||0.038|TWO_SIDED|95.0|0.01|0.46|||ANCOVA|||PRR score at 1 hour||0.46|0.01|0.038
91658158|NCT02863575|183210076|SUPERIORITY||LS means difference|2.01|||<|0.001|TWO_SIDED|95.0|1.69|2.33|||ANCOVA|||PRR score at 1 hour||2.33|1.69|< 0.001
91658159|NCT02863575|183210076|SUPERIORITY||LS means difference|1.78|||<|0.001|TWO_SIDED|95.0|1.46|2.09|||ANCOVA|||PRR score at 1 hour||2.09|1.46|< 0.001
91658160|NCT02863575|183210076|SUPERIORITY||LS means difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANCOVA|||PRR score at 1.5 hour||0.47|0.03|0.024
91618466|NCT03855137|183130207|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.45|3.14||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.14|1.45|0.0003
91658161|NCT02863575|183210076|SUPERIORITY||LS means difference|2.33|||<|0.001|TWO_SIDED|95.0|2.02|2.64|||ANCOVA|||PRR score at 1.5 hour||2.64|2.02|< 0.001
91658162|NCT02863575|183210076|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.77|2.39|||ANCOVA|||PRR score at 1.5 hour||2.39|1.77|< 0.001
91658163|NCT02863575|183210076|SUPERIORITY||LS means difference|0.18||||0.103|TWO_SIDED|95.0|-0.04|0.4|||ANCOVA|||PRR score at 2 hour||0.40|-0.04|0.103
91658164|NCT02863575|183210076|SUPERIORITY||LS means difference|2.4|||<|0.001|TWO_SIDED|95.0|2.09|2.71|||ANCOVA|||PRR score at 2 hour||2.71|2.09|< 0.001
91658165|NCT02863575|183210076|SUPERIORITY||LS means difference|2.22|||<|0.001|TWO_SIDED|95.0|1.91|2.53|||ANCOVA|||PRR score at 2 hour||2.53|1.91|< 0.001
91658166|NCT02863575|183210076|SUPERIORITY||LS means difference|0.08||||0.448|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||PRR score at 3 hour||0.29|-0.13|0.448
91658167|NCT02863575|183210076|SUPERIORITY||LS means difference|2.16|||<|0.001|TWO_SIDED|95.0|1.86|2.47|||ANCOVA|||PRR score at 3 hour||2.47|1.86|< 0.001
91658168|NCT02863575|183210076|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.78|2.38|||ANCOVA|||PRR score at 3 hour||2.38|1.78|< 0.001
91658169|NCT02863575|183210076|SUPERIORITY||LS means difference|0.0||||0.997|TWO_SIDED|95.0|-0.23|0.23|||ANCOVA|||PRR score at 4 hour||0.23|-0.23|0.997
91658170|NCT02863575|183210076|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
91618467|NCT03855137|183130207|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0009|TWO_SIDED|95.0|1.38|3.0||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.00|1.38|0.0009
91618468|NCT03855137|183130208|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0006|TWO_SIDED|95.0|1.38|2.98||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.98|1.38|0.0006
91618469|NCT03855137|183130208|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.79||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.79|1.29|0.0009
91658171|NCT02863575|183210076|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
91658172|NCT02863575|183210076|SUPERIORITY||LS means difference|0.06||||0.656|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|||PRR score at 5 hour||0.31|-0.19|0.656
91658173|NCT02863575|183210076|SUPERIORITY||LS means difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.09|||ANCOVA|||PRR score at 5 hour||2.09|1.36|< 0.001
91658174|NCT02863575|183210076|SUPERIORITY||LS means difference|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.03|||ANCOVA|||PRR score at 5 hour||2.03|1.31|< 0.001
91658175|NCT02863575|183210076|SUPERIORITY||LS means difference|0.11||||0.425|TWO_SIDED|94.0|-0.16|0.38|||ANCOVA|||PRR score at 6 hour||0.38|-0.16|0.425
91658176|NCT02863575|183210076|SUPERIORITY||LS means difference|1.51|||<|0.001|TWO_SIDED|95.0|1.12|1.9|||ANCOVA|||PRR score at 6 hour||1.90|1.12|< 0.001
91658177|NCT02863575|183210076|SUPERIORITY||LS means difference|1.4|||<|0.001|TWO_SIDED|95.0|1.01|1.79|||ANCOVA|||PRR score at 6 hour||1.79|1.01|< 0.001
91658178|NCT02863575|183210076|SUPERIORITY||LS means difference|-0.03||||0.841|TWO_SIDED|95.0|-0.32|0.26|||ANCOVA|||PRR score at 7 hour||0.26|-0.32|0.841
91658179|NCT02863575|183210076|SUPERIORITY||LS means difference|1.1|||<|0.001|TWO_SIDED|95.0|0.69|1.52|||ANCOVA|||PRR score at 7 hour||1.52|0.69|< 0.001
91658180|NCT02863575|183210076|SUPERIORITY||LS means difference|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.55|||ANCOVA|||PRR score at 7 hour||1.55|0.72|< 0.001
91658181|NCT02863575|183210076|SUPERIORITY||LS means difference|0.0||||0.98||95.0|-0.3|0.3|||ANCOVA|||PRR score at 8 hour||0.30|-0.30|0.980
91658182|NCT02863575|183210076|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.36|||ANCOVA|||PRR score at 8 hour||1.36|0.50|< 0.001
91658183|NCT02863575|183210076|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35|||ANCOVA|||PRR score at 8 hour||1.35|0.50|< 0.001
91524572|NCT02799472|182923994|OTHER||Median Difference (Net)|-2.18||||0.052|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \>0||0.51|-4.77|0.052
91658184|NCT02863575|183210077|SUPERIORITY||LS means difference|-0.03||||0.808|TWO_SIDED|95.0|-0.27|0.21|||ANCOVA|||PID score at 0.25 hour||0.21|-0.27|0.808
91658185|NCT02863575|183210077|SUPERIORITY||LS means difference|0.04||||0.804|TWO_SIDED|95.0|-0.3|0.39|||ANCOVA|||PID score at 0.25 hour||0.39|-0.30|0.804
91658186|NCT02863575|183210077|SUPERIORITY||LS means difference|0.07||||0.676|TWO_SIDED|95.0|-0.27|0.42|||ANCOVA|||PID score at 0.25 hr||0.42|-0.27|0.676
91658187|NCT02863575|183210077|SUPERIORITY||LS means difference|-0.1||||0.654|TWO_SIDED|95.0|-0.55|0.35|||ANCOVA|||PID score at 0.5 hour||0.35|-0.55|0.654
91658188|NCT02863575|183210077|SUPERIORITY||LS means difference|1.45|||<|0.001|TWO_SIDED|95.0|0.81|2.1|||ANCOVA|||PID score at 0.5 hour||2.10|0.81|< 0.001
91658189|NCT02863575|183210077|SUPERIORITY||LS means difference|1.55|||<|0.001|TWO_SIDED|95.0|0.91|2.2|||ANCOVA|||PID score at 0.5 hour||2.20|0.91|< 0.001
91658190|NCT02863575|183210077|SUPERIORITY||LS means difference|0.49||||0.045|TWO_SIDED|95.0|0.01|0.97|||ANCOVA|||PID score at 1 hour||0.97|0.01|0.045
91658191|NCT02863575|183210077|SUPERIORITY||LS means difference|4.1|||<|0.001||95.0|3.41|4.78|||ANCOVA|||PID score at 1 hour||4.78|3.41|< 0.001
91658192|NCT02863575|183210077|SUPERIORITY||LS means difference|3.6|||<|0.001|TWO_SIDED|95.0|2.92|4.29|||ANCOVA|||PID score at 1 hour||4.29|2.92|< 0.001
91658193|NCT02863575|183210077|SUPERIORITY||LS means difference|0.59||||0.015|TWO_SIDED|95.0|0.11|1.06|||ANCOVA|||PID score at 1.5 hour||1.06|0.11|0.015
91658194|NCT02863575|183210077|SUPERIORITY||LS means difference|5.03|||<|0.001|TWO_SIDED|95.0|4.35|5.71|||ANOVA|||PID score at 1.5 hour||5.71|4.35|< 0.001
91658195|NCT02863575|183210077|SUPERIORITY||LS means difference|4.44|||<|0.001|TWO_SIDED|95.0|3.76|5.12|||ANCOVA|||PID score at 1.5 hour||5.12|3.76|< 0.001
91658196|NCT02863575|183210077|SUPERIORITY||LS means difference|0.44||||0.066|TWO_SIDED|95.0|-0.03|0.91|||ANCOVA|||PID score at 2 hour||0.91|-0.03|0.066
91658197|NCT02863575|183210077|SUPERIORITY||LS means difference|5.22|||<|0.001|TWO_SIDED|95.0|4.54|5.89|||ANCOVA|||PID score at 2 hour||5.89|4.54|< 0.001
91658198|NCT02863575|183210077|SUPERIORITY||LS means difference|4.78|||<|0.001|TWO_SIDED|95.0|4.1|5.45|||ANCOVA|||PID score at 2 hour||5.45|4.10|< 0.001
91618470|NCT03855137|183130209|SUPERIORITY||Least Squares Mean Difference|7.43|STANDARD_ERROR_OF_MEAN|1.864||0.0006|TWO_SIDED|95.0|3.77|11.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||11.09|3.77|0.0006
91618471|NCT03855137|183130209|SUPERIORITY||Least Squares Mean Difference|5.78|STANDARD_ERROR_OF_MEAN|1.848||0.0024|TWO_SIDED|95.0|2.15|9.41||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||9.41|2.15|0.0024
91618472|NCT03855137|183130210|SUPERIORITY||Least Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|0.968||0.0003|TWO_SIDED|95.0|-6.75|-2.95||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.95|-6.75|0.0003
91618473|NCT03855137|183130210|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|0.963||0.0009|TWO_SIDED|95.0|-5.27|-1.49||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.49|-5.27|0.0009
91618474|NCT03855137|183130211|SUPERIORITY||Least Squares Mean Difference|-4.19|STANDARD_ERROR_OF_MEAN|0.897||0.0003|TWO_SIDED|95.0|-5.95|-2.43||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.43|-5.95|0.0003
91618475|NCT03855137|183130211|SUPERIORITY||Least Squares Mean Difference|-2.71|STANDARD_ERROR_OF_MEAN|0.893||0.0025|TWO_SIDED|95.0|-4.47|-0.96||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.96|-4.47|0.0025
91618476|NCT03855137|183130212|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.697||0.0006|TWO_SIDED|95.0|-4.67|-1.93|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.93|-4.67|0.0006
91618477|NCT03855137|183130212|SUPERIORITY||Least Squares Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|0.69||0.0024|TWO_SIDED|95.0|-4.02|-1.3|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.30|-4.02|0.0024
91618478|NCT02435277|183130215|OTHER|||||||0.0475||||||Total daily dose is twice the respective dose, Pairwise Comparison using Control as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)||||0.0475
91618479|NCT02435277|183130215|OTHER|||||||0.0912|||||||ANCOVA|||||||0.0912
91618480|NCT02435277|183130215|OTHER|||||||0.0458|||||||ANCOVA|||||||0.0458
91658199|NCT02863575|183210077|SUPERIORITY||LS means difference|0.32||||0.186|TWO_SIDED|95.0|-0.16|0.81|||ANCOVA|||PID score at 3 hour||0.81|-0.16|0.186
91658200|NCT02863575|183210077|SUPERIORITY||LS means difference|4.66|||<|0.001|TWO_SIDED|95.0|3.98|5.35|||ANCOVA|||PID score at 3 hour||5.35|3.98|< 0.001
91618481|NCT02435277|183130216|OTHER|||||||0.26||||||Total daily dose is twice the respective dose Pairwise Comparison using Treatment D as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of Fssting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)||||0.26
91618482|NCT02435277|183130216|OTHER|||||||0.0083|||||||ANCOVA|||||||0.0083
91618483|NCT02435277|183130216|OTHER|||||||0.0317|||||||ANCOVA|||||||0.0317
91658201|NCT02863575|183210077|SUPERIORITY||LS means difference|4.34|||<|0.001|TWO_SIDED|95.0|3.65|5.03|||ANCOVA|||PID score at 3 hour||5.03|3.65|< 0.001
91658202|NCT02863575|183210077|SUPERIORITY||LS means difference|0.08||||0.75|TWO_SIDED|95.0|-0.43|0.6|||ANCOVA|||PID score at 4 hour||0.60|-0.43|0.750
91658203|NCT02863575|183210077|SUPERIORITY||LS means difference|4.14|||<|0.001|TWO_SIDED|95.0|3.4|4.87|||ANCOVA|||PID score at 4 hour||4.87|3.40|< 0.001
91658204|NCT02863575|183210077|SUPERIORITY||LS means difference|4.05|||<|0.001|TWO_SIDED|95.0|3.32|4.79|||ANCOVA|||PID score at 4 hour||4.79|3.32|< 0.001
91658205|NCT02863575|183210077|SUPERIORITY||LS means difference|0.26||||0.361|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|||PID score at 5 hour||0.81|-0.30|0.361
91658206|NCT02863575|183210077|SUPERIORITY||LS means difference|3.74|||<|0.001|TWO_SIDED|95.0|2.95|4.53|||ANCOVA|||PID score at 5 hour||4.53|2.95|< 0.001
91658207|NCT02863575|183210077|SUPERIORITY||LS means difference|3.48|||<|0.001|TWO_SIDED|95.0|2.69|4.27|||ANCOVA|||PID score at 5 hour||4.27|2.69|< 0.001
91658208|NCT02863575|183210077|SUPERIORITY||LS means difference|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.98|||ANCOVA|||PID score at 6 hour||0.98|-0.20|0.195
91658209|NCT02863575|183210077|SUPERIORITY||LS means difference|3.29|||<|0.001|TWO_SIDED|95.0|2.44|4.13|||ANCOVA|||PID score at 6 hour||4.13|2.44|< 0.001
91658210|NCT02863575|183210077|SUPERIORITY||LS means difference|2.9|||<|0.001|TWO_SIDED|95.0|2.06|3.74|||ANCOVA|||PID score at 6 hour||3.74|2.06|< 0.001
91658211|NCT02863575|183210077|SUPERIORITY||LS means difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.76|||ANCOVA|||PID score at 7 hour||0.76|-0.49|0.669
91658212|NCT02863575|183210077|SUPERIORITY||LS means difference|2.42|||<|0.001|TWO_SIDED|95.0|1.53|3.31|||ANCOVA|||PID score at 7 hour||3.31|1.53|< 0.001
91658213|NCT02863575|183210077|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.4|3.18|||ANCOVA|||PID score at 7 hour||3.18|1.40|< 0.001
91658214|NCT02863575|183210077|SUPERIORITY||LS means difference|0.18||||0.581|TWO_SIDED|95.0|-0.46|0.82|||ANCOVA|||PID score at 8 hour||0.82|-0.46|0.581
91658215|NCT02863575|183210077|SUPERIORITY||LS means difference|2.09|||<|0.001|TWO_SIDED|95.0|1.18|3.0|||ANCOVA|||PID score at 8 hour||3.00|1.18|< 0.001
91658216|NCT02863575|183210077|SUPERIORITY||LS means difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||PID score at 8 hour||2.82|1.00|< 0.001
91658217|NCT02863575|183210078|SUPERIORITY|||||||0.028|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.028
91658218|NCT02863575|183210078|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
91658219|NCT02863575|183210078|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
91658220|NCT02863575|183210079|SUPERIORITY|||||||0.861|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.861
91658221|NCT02863575|183210079|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
91658222|NCT02863575|183210079|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
91658223|NCT02863575|183210080|SUPERIORITY|||||||0.838|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.838
91658224|NCT02863575|183210080|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
91658225|NCT02863575|183210080|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
91658226|NCT01706926|183210086|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.06|-0.31|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.31|-1.06|<0.001
91658227|NCT01706926|183210086|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.58|-1.33|<0.001
91658228|NCT01706926|183210086|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.6|-0.84|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.84|-1.60|<0.001
91658229|NCT01706926|183210087|SUPERIORITY_OR_OTHER||Percent difference|25.9|||<|0.001|TWO_SIDED|95.0|11.5|40.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||40.3|11.5|<0.001
91658230|NCT01706926|183210087|SUPERIORITY_OR_OTHER||Percent difference|36.5|||<|0.001|TWO_SIDED|95.0|22.5|50.5|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||50.5|22.5|<0.001
91658231|NCT01706926|183210087|SUPERIORITY_OR_OTHER||Percent difference|48.7|||<|0.001|TWO_SIDED|95.0|35.2|62.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||62.3|35.2|<0.001
91524573|NCT02799472|182923994|OTHER||Median Difference (Net)|-2.28||||0.051|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \>0||0.45|-5.02|0.051
91658232|NCT01706926|183210094|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.013|TWO_SIDED|95.0|3.9|28.2|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||28.2|3.9|0.013
91618484|NCT01552928|183130251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
91618485|NCT01552928|183130251|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618486|NCT01552928|183130251|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618487|NCT01552928|183130252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618488|NCT01552928|183130252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618489|NCT01552928|183130252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91618490|NCT01552928|183130253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANCOVA|||||||0.012
91618491|NCT01552928|183130253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044|||||||ANCOVA|||||||0.044
91618492|NCT01552928|183130253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618493|NCT01552928|183130254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618494|NCT01552928|183130254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618495|NCT01552928|183130254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618496|NCT01552928|183130255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||||||0.003
91618497|NCT01552928|183130255|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618498|NCT01552928|183130255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANCOVA|||||||0.043
91618499|NCT01552928|183130260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618500|NCT01552928|183130260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618501|NCT01552928|183130260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618502|NCT01552928|183130261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618503|NCT01552928|183130261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618504|NCT01552928|183130261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
91618505|NCT01552928|183130262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANCOVA|||||||0.005
91618506|NCT01552928|183130262|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618507|NCT01552928|183130262|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618508|NCT01552928|183130263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANCOVA|||||||0.078
91618509|NCT01552928|183130263|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618510|NCT01552928|183130263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.156|||||||ANCOVA|||||||0.156
91618511|NCT01552928|183130264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.439|||||||ANCOVA|||||||0.439
91618512|NCT01552928|183130264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||ANCOVA|||||||0.274
91618513|NCT01552928|183130264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91618514|NCT04973228|183130268|SUPERIORITY||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.75|4.45|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 8||4.45|1.75|<0.0001
91618515|NCT04973228|183130269|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0001|TWO_SIDED|95.0|1.68|5.19|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 8||5.19|1.68|0.0001
91618516|NCT04973228|183130270|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0007|TWO_SIDED|95.0|1.47|4.67|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 4||4.67|1.47|0.0007
91618517|NCT04973228|183130271|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0016|TWO_SIDED|95.0|1.41|5.34|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 2||5.34|1.41|0.0016
91618518|NCT04973228|183130272|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.54|3.84|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 2||3.84|1.54|0.0002
91618519|NCT04973228|183130273|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.06|5.03|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 4||5.03|2.06|<0.0001
91618520|NCT04973228|183130274|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.56|3.73|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Scaling Score of 0 at Week 8||3.73|1.56|<0.0001
91618521|NCT04973228|183130275|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.05|5.06|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Erythema Score of 0 at Week 8||5.06|2.05|<0.0001
91618522|NCT03492463|183130280|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Due to time and budget constraints a blinded decision was made and approved by the funding agency to limit further enrollment to the two conditions that provided nicotine patches. The primary (one-tailed) test compared Nicotine e-cigs + Nicotine patches to Non-nicotine e-cigs + Nicotine patches.||||0.01
91618523|NCT03492463|183130281|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
91618524|NCT03492463|183130282|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
91618525|NCT00406640|183130284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67||||0.243||95.0|-0.46|1.81|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared with ESC||1.81|-0.46|0.243
91791576|NCT03274999|183460931|SUPERIORITY|||||||0.39||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.390
91618526|NCT00406640|183130285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.608||||0.077||95.0|0.4|0.92|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.92|0.40|0.077
91618527|NCT00406640|183130286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.571||||0.0054||95.0|0.39|0.85|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.85|0.39|0.0054
91618528|NCT00406640|183130287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.26||95.0|-0.09|0.33|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|DVS SR compared with ESC||0.33|-0.09|0.260
91618529|NCT00406640|183130288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.239||95.0|-0.09|0.37|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|||0.37|-0.09|0.239
91618530|NCT00406640|183130289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.37||||0.516||95.0|-0.75|1.49|||Mixed Models Analysis|Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared to ESC||1.49|-0.75|0.516
91618531|NCT00406640|183130290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.635||95.0|-0.03|0.06|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.|DVS SR adjusted mean change minus ESC adjusted mean change|DVS SR compared to ESC||0.06|-0.03|0.635
91618532|NCT00406640|183130291|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.702||95.0|0.63|2.0|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.00|0.63|0.702
91618533|NCT00406640|183130292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.234||95.0|0.83|2.16|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.16|0.83|0.234
91658233|NCT01706926|183210094|SUPERIORITY_OR_OTHER||Percent difference|13.5||||0.03|TWO_SIDED|95.0|1.8|25.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||25.3|1.8|0.030
91658234|NCT01706926|183210094|SUPERIORITY_OR_OTHER||Percent difference|28.2|||<|0.001|TWO_SIDED|95.0|15.2|41.1|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||41.1|15.2|<0.001
91791577|NCT03274999|183460932|SUPERIORITY|||||||0.053||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.053
91618534|NCT00406640|183130296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: end of therapy||||0.927
91618535|NCT00406640|183130296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 1 week of taper||||0.055
91618536|NCT00406640|183130296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 2 weeks of taper||||0.025
91618537|NCT00406640|183130296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after \> 2 weeks of taper||||0.653
91791578|NCT03274999|183460932|SUPERIORITY|||||||0.206||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.206
91791579|NCT03274999|183460932|SUPERIORITY|||||||0.221||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.221
91791580|NCT03274999|183460932|SUPERIORITY|||||||0.126||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.126
91618538|NCT02198651|183130297|OTHER|||||||0.943|||||||Wald Chi|||||||0.943
91618539|NCT02198651|183130298|OTHER|||||||0.592|||||||Wald Chi|||||||0.592
91618540|NCT02198651|183130299|OTHER|||||||0.688|||||||Wald Chi|||||||0.688
91618541|NCT02922634|183130349|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
91618542|NCT02922634|183130350|SUPERIORITY|||||||0.72||||||The chi-squared test for both males and females with and without delirium.|Chi-squared|||||||0.720
91618543|NCT02922634|183130351|SUPERIORITY|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
91618544|NCT02922634|183130352|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
91618545|NCT02922634|183130353|SUPERIORITY|||||||0.028|||||||Chi-squared|||||||0.028
91618546|NCT02922634|183130354|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
91618547|NCT02922634|183130355|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91618548|NCT02922634|183130356|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91618549|NCT02922634|183130357|SUPERIORITY|||||||0.101|||||||Chi-squared|||||||0.101
91791581|NCT03274999|183460932|SUPERIORITY|||||||0.124||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.124
91618550|NCT02922634|183130358|SUPERIORITY|||||||0.192|||||||Chi-squared|||||||0.192
91618551|NCT02922634|183130359|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.200
91618552|NCT02922634|183130360|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
91618553|NCT02922634|183130361|SUPERIORITY|||||||0.001||||||This is a chi-squared test between the FRAIL categories for participants with or without delirium.|Chi-squared|||||||0.001
91618554|NCT02922634|183130362|SUPERIORITY|||||||0.002||||||This is a chi-squared test of the categories for levels of invasiveness for participants with or without delirium.|Chi-squared|||||||0.002
91618555|NCT02625324|183130365|SUPERIORITY||Event Rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
91618556|NCT03534063|183130388|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|Comparisons for opioid consumption and composite pain intensity were performed by analysis of covariance, adjusting for baseline differences in groups||||||.047
91618557|NCT03534063|183130389|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||.638
91618558|NCT02397694|183130390|NON_INFERIORITY|Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%|Difference in percentages|2.9||||0.5|TWO_SIDED|95.0|-8.5|14.2|||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs \> 100,000 copies/mL).||||14.2|-8.5|0.5
91618559|NCT00424528|183130406|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as covariate and treatment group as fixed effect.||||||<0.001
91658235|NCT01706926|183210095|SUPERIORITY_OR_OTHER||Percent difference|8.6||||0.079|TWO_SIDED|95.0|0.4|16.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||16.9|0.4|0.079
91658236|NCT01706926|183210095|SUPERIORITY_OR_OTHER||Percent difference|6.9||||0.133|TWO_SIDED|95.0|-0.8|14.6|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||14.6|-0.8|0.133
91524574|NCT02799472|182923995|OTHER||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.2|0.3|||Repeated measures analysis|||Week 4||0.3|-0.2|0.940
91618560|NCT00424528|183130406|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study Baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
91658237|NCT01706926|183210095|SUPERIORITY_OR_OTHER||Percent difference|10.2||||0.026|TWO_SIDED|95.0|1.5|18.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||18.9|1.5|0.026
91658238|NCT01706926|183210096|SUPERIORITY_OR_OTHER||Adjusted Mean difference|15.79|STANDARD_ERROR_OF_MEAN|6.007||0.009|TWO_SIDED|95.0|3.96|27.61|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||27.61|3.96|0.009
91618561|NCT00424528|183130406|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Primary analysis:Group 2 vs 3. Key secondary analysis: Group 1 vs 3. Multiple comparisons for the analysis of the primary endpoint were controlled at the 5% level.|ANCOVA|Study baseline FEV1 as a covariate and treatment group as fixed effect.||||||<0.001
91618562|NCT00424528|183130407|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
91618563|NCT00424528|183130407|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
91618564|NCT00424528|183130408|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
91618565|NCT00424528|183130408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
91618566|NCT00424528|183130409|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.073
91618567|NCT00424528|183130409|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.050
91618568|NCT00424528|183130412|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANCOVA|Week 0 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0 comparisons||||0.060
91618569|NCT00424528|183130412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0||||<0.001
91618570|NCT00424528|183130412|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.004
91618571|NCT00424528|183130412|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.002
91618572|NCT00424528|183130415|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.206
91658239|NCT01706926|183210096|SUPERIORITY_OR_OTHER||Adjusted mean difference|16.99|STANDARD_ERROR_OF_MEAN|5.879||0.004|TWO_SIDED|95.0|5.42|28.56|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.56|5.42|0.004
91658240|NCT01706926|183210096|SUPERIORITY_OR_OTHER||Adjusted mean difference|27.47|STANDARD_ERROR_OF_MEAN|5.892|<|0.001|TWO_SIDED|95.0|15.87|39.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||39.07|15.87|<0.001
91658241|NCT01706926|183210097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.56|8.8|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (\>) one favored mavrilimumab.|||8.80|2.56|<0.001
91658242|NCT01706926|183210097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.001|TWO_SIDED|95.0|2.64|8.92|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|||8.92|2.64|<0.001
91658243|NCT01706926|183210097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.11|||<|0.001|TWO_SIDED|95.0|3.85|13.4|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||13.40|3.85|<0.001
91658244|NCT01706926|183210098|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.004|TWO_SIDED|95.0|6.0|26.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||26.1|6.0|0.004
91658245|NCT01706926|183210098|SUPERIORITY_OR_OTHER||Percent difference|12.7||||0.014|TWO_SIDED|95.0|3.3|22.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||22.1|3.3|0.014
91658246|NCT01706926|183210098|SUPERIORITY_OR_OTHER||Percent difference|14.0||||0.007|TWO_SIDED|95.0|4.2|23.9|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||23.9|4.2|0.007
91658247|NCT01706926|183210098|SUPERIORITY_OR_OTHER||Percent difference|24.7|||<|0.001|TWO_SIDED|95.0|12.7|36.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||36.6|12.7|<0.001
91658248|NCT01706926|183210098|SUPERIORITY_OR_OTHER||Percent difference|23.1|||<|0.001|TWO_SIDED|95.0|11.5|34.8|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||34.8|11.5|<0.001
91658249|NCT01706926|183210098|SUPERIORITY_OR_OTHER||Percent difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||45.6|20.7|<0.001
91712934|NCT03311841|183317584|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.27|1.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.86|0.27|
91658250|NCT01706926|183210099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.237|<|0.001|TWO_SIDED|95.0|-8.12|-3.24|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.24|-8.12|<0.001
91791582|NCT03274999|183460932|SUPERIORITY|||||||0.167||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.167
91791583|NCT03274999|183460932|SUPERIORITY|||||||0.377||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.377
91791584|NCT03274999|183460932|SUPERIORITY|||||||0.397||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.397
91791585|NCT03274999|183460932|SUPERIORITY|||||||0.441||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.441
91524575|NCT02799472|182923995|OTHER||Mean Difference (Net)|-0.8||||0.521|TWO_SIDED|95.0|-3.2|1.6|||Repeated measures analysis|||Week 12||1.6|-3.2|0.521
91618573|NCT00424528|183130415|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.025
91618574|NCT02115113|183130422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.24|STANDARD_ERROR_OF_MEAN|5.01||0.3013|TWO_SIDED|95.0|-4.86|15.34|||ANOVA|||||15.34|-4.86|0.3013
91618575|NCT01313520|183130429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||Constrained Longitudinal Data Analysis|||||-0.1|-0.4|<0.001
91618576|NCT01313520|183130430|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
91618577|NCT01313520|183130431|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
91618578|NCT01313520|183130432|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Constrained longitudinal data analysis|||||||<0.0001
91618579|NCT01313520|183130433|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||van Elteren test|||||||0.001
91618580|NCT01313520|183130434|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||van Elteren test|||||||0.0005
91712935|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|95.0|0.4|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.40|
91524576|NCT02799472|182923995|OTHER||Mean Difference (Net)|-1.3||||0.396|TWO_SIDED|95.0|-4.4|1.8|||Repeated measures analysis|||12-Week FU||1.8|-4.4|0.396
91618581|NCT01313520|183130435|SUPERIORITY_OR_OTHER||Effect Size|1.4|||||TWO_SIDED|90.0|0.92|1.87||||||||1.87|0.92|
91618582|NCT01313520|183130436|SUPERIORITY_OR_OTHER||Effect Size|1.1|||||TWO_SIDED|90.0|0.64|1.55||||||||1.55|0.64|
91618583|NCT00789191|183130437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001||95.0|-0.77|-0.33||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|Analysis of covariance (ANCOVA) was used; baseline HbA1c was included as covariate and treatment, stratification and country was included as factors||Null hypothesis: Difference between mean HbA1c in the two treatment arms is equal to zero. Power calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%||-0.33|-0.77|0.0010
91618584|NCT00789191|183130438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2||||0.001||95.0|1.65|6.19||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||6.19|1.65|0.0010
91618585|NCT00789191|183130439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.008||95.0|1.26|4.81||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||4.81|1.26|0.0080
91618586|NCT00789191|183130440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.063||95.0|0.96|5.2||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||5.20|0.96|0.063
91618587|NCT00789191|183130441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.135||95.0|0.8|5.37||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic||Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate|Null hypothesis: Odds ratio is equal to one.||5.37|0.8|0.135
91618588|NCT00789191|183130442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.121||95.0|-0.07|0.63||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||0.63|-0.07|0.121
91618589|NCT00789191|183130443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84||||0.109||95.0|-0.19|1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||1.88|-0.19|0.109
91618590|NCT00789191|183130444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.45||||0.001||95.0|-3.01|-1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||-1.88|-3.01|0.0010
91618591|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||||95.0|-2.5|-1.51|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast|||-1.51|-2.50|
91618592|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-2.4|-0.89|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of breakfast|||-0.89|-2.40|
91618593|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||||95.0|-1.69|-0.35|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before lunch|||-0.35|-1.69|
91618594|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||95.0|-2.05|-0.56|||Linear mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of lunch|||-0.56|-2.05|
91618595|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.77||||||95.0|-1.58|0.05|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before dinner|||0.05|-1.58|
91658251|NCT01706926|183210099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.211|<|0.001|TWO_SIDED|95.0|-8.6|-3.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.82|-8.60|<0.001
91618596|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||||95.0|-1.75|-0.02|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of dinner|||-0.02|-1.75|
91618597|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||||95.0|-1.88|-0.2|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Bedtime|||-0.20|-1.88|
91618598|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||||95.0|-1.84|-0.49|||Linear Mixed Model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. At 03:00 a.m.|||-0.49|-1.84|
91618599|NCT00789191|183130448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||||95.0|-2.26|-1.34|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast the following day|||-1.34|-2.26|
91618600|NCT03736629|183130453|SUPERIORITY||Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|1.72||0.72|TWO_SIDED|95.0|-6.14|4.81|||t-test, 2 sided|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||4.81|-6.14|0.72
91618601|NCT03736629|183130454|SUPERIORITY||Mean Difference (Net)|-5.67||||0.59|TWO_SIDED|95.0|-35.98|24.65|||t-test, 2 sided||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.|||24.65|-35.98|0.59
91618602|NCT03736629|183130457|SUPERIORITY|||||||1|||||||Fisher Exact|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||||1.0
91618603|NCT00797797|183130472|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.||||<0.001
91618604|NCT00797797|183130473|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-14.35|||||TWO_SIDED|95.0|-18.99|-9.71|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-9.71|-18.99|
91618605|NCT00442013|183130521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.086||0.12|TWO_SIDED|95.0|0.0|0.3|||Regression, Linear|Linear mixed effects model is robust to data that are missing at random that has characteristics similar to multiple imputation techniques.||All participants included in the analysis. The model includes the data (ACQ scores) from all time points including baseline. The treatment effect (delta-delta) comparing the difference from baseline at 6 months is estimated from the model. Longitudinal models estimated the change from baseline to 6 months in a measurement using generalized estimating equations with an unstructured or exchangeable covariance matrix to adjust for repeated measures.||0.3|0.0|0.12
91618606|NCT00442013|183130522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2593||0.65|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.65
91618607|NCT00442013|183130523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0906||0.99|TWO_SIDED|95.0|-0.1|0.1|||Regression, Linear|||||0.1|-0.1|0.99
91618608|NCT00442013|183130524|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.7|||negative binomial|||||1.7|0.9|0.30
91618609|NCT00442013|183130525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.14|TWO_SIDED|95.0|-0.07|0.01|||Regression, Linear|Model includes the data from all time points. Treatment effect (delta-delta) comparing the difference from baseline at 24 weeks is from the model.||||0.01|-0.07|0.14
91618610|NCT00442013|183130526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.2|TWO_SIDED|95.0|-2.1|0.4|||Regression, Linear|||||0.4|-2.1|0.20
91618611|NCT01774344|183130536|SUPERIORITY||Hazard Ratio (HR)|0.624|||=|1.7e-05|TWO_SIDED|95.0|0.498|0.782|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.782|0.498|= 0.000017
91618612|NCT01774344|183130536|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.000149|TWO_SIDED|95.0|0.527|0.828|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.828|0.527|= 0.000149
91618613|NCT01774344|183130536|SUPERIORITY||Hazard Ratio (HR)|0.674|||=|0.000107|TWO_SIDED|95.0|0.546|0.831|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.831|0.546|= 0.000107
91618614|NCT01774344|183130537|SUPERIORITY||Hazard Ratio (HR)|0.439|||<|1e-06|TWO_SIDED|95.0|0.355|0.542|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.542|0.355|< 0.000001
91658252|NCT01706926|183210099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.219|<|0.001|TWO_SIDED|95.0|-9.4|-4.59|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-4.59|-9.40|<0.001
91712936|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.76|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.09|0.76|
91658253|NCT01706926|183210099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.24|STANDARD_ERROR_OF_MEAN|1.922|<|0.001|TWO_SIDED|95.0|-11.02|-3.45|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-3.45|-11.02|<0.001
91658254|NCT01706926|183210099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.45|STANDARD_ERROR_OF_MEAN|1.884|<|0.001|TWO_SIDED|95.0|-12.16|-4.74|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-4.74|-12.16|<0.001
91658255|NCT01706926|183210099|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.42|STANDARD_ERROR_OF_MEAN|1.901|<|0.001|TWO_SIDED|95.0|-14.17|-6.67|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-6.67|-14.17|<0.001
91658256|NCT01706926|183210100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.94|STANDARD_ERROR_OF_MEAN|3.95||0.045|TWO_SIDED|95.0|-15.72|-0.17|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.17|-15.72|0.045
91658257|NCT01706926|183210100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.11|STANDARD_ERROR_OF_MEAN|3.876||0.037|TWO_SIDED|95.0|-15.73|-0.48|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.48|-15.73|0.037
91658258|NCT01706926|183210100|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.32|STANDARD_ERROR_OF_MEAN|3.899||0.004|TWO_SIDED|95.0|-19.0|-3.65|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-3.65|-19.00|0.004
91658259|NCT01706926|183210101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.137||0.837|TWO_SIDED|95.0|-8.99|7.29|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||7.29|-8.99|0.837
91658260|NCT01706926|183210101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|4.058||0.589|TWO_SIDED|95.0|-10.18|5.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||5.79|-10.18|0.589
91658261|NCT01706926|183210101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.48|STANDARD_ERROR_OF_MEAN|4.083||0.18|TWO_SIDED|95.0|-13.52|2.55|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||2.55|-13.52|0.180
91658262|NCT01706926|183210102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.2|-0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.63|-2.20|<0.001
91658263|NCT01706926|183210102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|0.389|<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.69|-2.23|<0.001
91658264|NCT01706926|183210102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.391|<|0.001|TWO_SIDED|95.0|-2.33|-0.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.79|-2.33|<0.001
91712937|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.52|0.57|
91712938|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|0.42|||||TWO_SIDED|95.0|0.25|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.25|
91712939|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|0.96|||||TWO_SIDED|95.0|0.53|1.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.73|0.53|
91712940|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|2.38|||||TWO_SIDED|95.0|1.32|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||4.32|1.32|
91524577|NCT02799472|182923996|OTHER||Mean Difference (Net)|0.0||||0.945|TWO_SIDED|95.0|-1.1|1.2|||Repeated measures analysis|||Week 4||1.2|-1.1|0.945
91658265|NCT01706926|183210103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.479|TWO_SIDED|95.0|-0.29|0.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.14|-0.29|0.479
91658266|NCT01706926|183210103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.106||0.124|TWO_SIDED|95.0|-0.37|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.04|-0.37|0.124
91658267|NCT01706926|183210103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.107||0.017|TWO_SIDED|95.0|-0.47|-0.05|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.05|-0.47|0.017
91658268|NCT01706926|183210104|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.64||||0.017|TWO_SIDED|95.0|0.45|0.92|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.92|0.45|0.017
91658269|NCT01706926|183210104|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.32|0.66|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.66|0.32|<0.001
91712941|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|3.09|||||TWO_SIDED|95.0|1.75|5.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.48|1.75|
91618615|NCT01774344|183130537|SUPERIORITY||Hazard Ratio (HR)|0.471|||<|1e-06|TWO_SIDED|95.0|0.388|0.572|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.572|0.388|< 0.000001
91618616|NCT01774344|183130537|SUPERIORITY||Hazard Ratio (HR)|0.412|||<|1e-06|TWO_SIDED|95.0|0.334|0.509|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.509|0.334|< 0.000001
91618617|NCT01774344|183130537|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|1e-06|TWO_SIDED|95.0|0.365|0.539|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.539|0.365|< 0.000001
91712942|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.8|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||2.64|0.80|
91618618|NCT01774344|183130538|SUPERIORITY||Hazard Ratio (HR)|0.453|||<|1e-06|TWO_SIDED|95.0|0.369|0.555|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.555|0.369|< 0.000001
91618619|NCT01774344|183130538|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|1e-06|TWO_SIDED|95.0|0.397|0.58|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.580|0.397|< 0.000001
91618620|NCT01774344|183130538|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|1e-06|TWO_SIDED|95.0|0.347|0.522|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.522|0.347|< 0.000001
91618621|NCT01774344|183130538|SUPERIORITY||Hazard Ratio (HR)|0.454|||<|1e-06|TWO_SIDED|95.0|0.376|0.548|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.548|0.376|< 0.000001
91618622|NCT01774344|183130539|SUPERIORITY||Difference|-6.88|||=|0.00365|TWO_SIDED|95.0|-11.13|-2.63|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-2.63|-11.13|= 0.003650
91618623|NCT01774344|183130539|SUPERIORITY||Difference|-4.15|||=|0.019991|TWO_SIDED|95.0|-7.55|-0.75|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-0.75|-7.55|= 0.019991
91618624|NCT01774344|183130540|SUPERIORITY||Difference|-29.31|||<|1e-06|TWO_SIDED|95.0|-37.52|-21.11|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-21.11|-37.52|< 0.000001
91524578|NCT02799472|182923996|OTHER||Mean Difference (Net)|-0.4||||0.475|TWO_SIDED|95.0|-1.5|0.7|||Repeated measures analysis|||Week 12||0.7|-1.5|0.475
91618625|NCT01774344|183130540|SUPERIORITY||Difference|-31.39|||<|1e-06|TWO_SIDED|95.0|-39.57|-23.22|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-23.22|-39.57|< 0.000001
91618626|NCT03664193|183130542|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 37.5 Gy.|Proportion (percent)|30.0|||||TWO_SIDED|95.0|14.7|49.3||||||||49.3|14.7|
91618627|NCT03664193|183130542|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 40.0 Gy.|Proportion (percent)|46.7|||||TWO_SIDED|95.0|28.3|65.7||||||||65.7|28.3|
91618628|NCT03664193|183130542|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 42.5 Gy.|Proportion (percent)|6.7|||||TWO_SIDED|95.0|0.8|22.1||||||||22.1|0.8|
91618629|NCT03664193|183130542|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 45.0 Gy.|Proportion (percent)|16.7|||||TWO_SIDED|95.0|5.6|34.7||||||||34.7|5.6|
91618630|NCT03664193|183130543|OTHER|Simple proportion and exact 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100.0|88.4|
91658270|NCT01706926|183210104|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.63|0.31|<0.001
91658271|NCT01706926|183210105|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.89|0.58|0.003
91658272|NCT01706926|183210105|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.84|0.55|<0.001
91658273|NCT01706926|183210105|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.75|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.75|0.49|<0.001
91658274|NCT01706926|183210106|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
91712943|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.78|2.2|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.20|0.78|
91712944|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.09|3.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.09|1.09|
91712945|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.77|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.09|0.77|
91524579|NCT02799472|182923996|OTHER||Mean Difference (Net)|-0.9||||0.086|TWO_SIDED|95.0|-2.0|0.1|||Repeated measures analysis|||12-Week FU||0.1|-2.0|0.086
91618631|NCT04866303|183130547|OTHER|unadjusted logistic regression model|Odds Ratio (OR)|1.79||||0.04|TWO_SIDED|95.0|1.03|2.8|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate.||2.80|1.03|0.04
91618632|NCT04866303|183130548|OTHER||Odds Ratio (OR)|1.39||||0.18|TWO_SIDED|95.0|0.86|2.26|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate||2.26|0.86|0.18
91618633|NCT04507867|183130550|OTHER|Kaplan-Meier method for overall survival.||||||0.027|||||||Log Rank|||The total number of patients who did or did not survive to day 40 of follow-up.||||0.027
91618634|NCT04507867|183130552|OTHER|Kaplan-Meier method||||||0.495|||||||Log Rank|||the total number of patients who were intubated and survived at the end of day 40 follow-up.||||0.495
91618635|NCT04507867|183130554|OTHER|Kaplan-Meier method||||||0.186|||||||Log Rank|||total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.||||0.186
91618636|NCT04507867|183130555|SUPERIORITY|Fisher exact test||||||0.35|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay. It was categorized as follows: 1. normal bristol scale at day 3; 2. abnormal bristol scale at day 3.||||0.35
91618637|NCT04507867|183130556|SUPERIORITY|||||||0.043|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.043
91618638|NCT04507867|183130557|SUPERIORITY|||||||0.241|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.241
91618639|NCT04507867|183130558|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Intragroup analysis at the control group, the measurement was performed at baseline and at hospital discharge.||||0.187
91618640|NCT04507867|183130558|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Intragroup analysis at the intervention group, the measurement was performed at baseline and at hospital discharge.||||0.003
91658275|NCT01706926|183210106|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-2.9|5.1|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||5.1|-2.9|1.000
91524580|NCT02799472|182923997|OTHER||Mean Difference (Net)|211.4||||0.874|TWO_SIDED|95.0|-2589.2|3012.0|||Repeated measures analysis|||Week 4||3012.0|-2589.2|0.874
91524581|NCT02799472|182923997|OTHER||Mean Difference (Net)|-504.8||||0.749|TWO_SIDED|95.0|-3730.4|2720.9|||Repeated measures analysis|||Week 12||2720.9|-3730.4|0.749
91618641|NCT04507867|183130559|SUPERIORITY|||||||0.919|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.919
91618642|NCT04507867|183130559|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.014
91618643|NCT04507867|183130560|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||Intragroup analysis of the control group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.608
91618644|NCT04507867|183130560|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Intragroup analysis of the intervention group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.04
91618645|NCT04507867|183130561|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.||||0.014
91618646|NCT04507867|183130562|SUPERIORITY|||||||0.008|||||||Fisher Exact|the shapiro wilk test was used to analyze the distribution of the data.||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.||||0.008
91618647|NCT04507867|183130564|SUPERIORITY|Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||||0.078|||||||Fisher Exact|||||||0.078
91618648|NCT04507867|183130565|SUPERIORITY|||||||0.098|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded||||0.098
91618649|NCT04507867|183130566|OTHER|||||||0.195|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group to analyze the presentation of post covid syndrome at the end of follow-up at day 40.||||0.195
91618650|NCT04507867|183130567|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.135
91618651|NCT04507867|183130568|SUPERIORITY|||||||0.266|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.266
91618652|NCT04507867|183130569|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.002|||||||Fisher Exact|||||||0.002
91618653|NCT04507867|183130570|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.003|||||||Fisher Exact|||||||0.003
91618654|NCT04507867|183130571|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.004|||||||Fisher Exact|||||||0.004
91618655|NCT04507867|183130572|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.011|||||||Fisher Exact|||||||0.011
91618656|NCT04507867|183130573|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.031|||||||Fisher Exact|||||||0.031
91618657|NCT04507867|183130574|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.04|||||||Fisher Exact|||||||0.040
91618658|NCT04507867|183130575|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.047|||||||Fisher Exact|||||||0.047
91618659|NCT02175771|183130581|SUPERIORITY||geometric mean ratio|1.32|||||TWO_SIDED|90.0|1.02|1.72|||||Fp MDPI / FLOVENT HFA|Mid-strength comparison||1.72|1.02|
91618660|NCT02175771|183130581|SUPERIORITY||geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.63|1.04|||||Fp MDPI / FLOVENT HFA|High-strength comparison||1.04|0.63|
91618661|NCT02175771|183130581|SUPERIORITY||geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.75|1.24|||||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||1.24|0.75|
91618662|NCT02175771|183130581|SUPERIORITY||geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.67|1.06|||||FS MDPI / ADVAIR DISKUS|High-strength comparison||1.06|0.67|
91618663|NCT02175771|183130582|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.009|STANDARD_ERROR_OF_MEAN|0.0476||0.8451|TWO_SIDED|95.0|-0.084|0.103|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|Mid-strength comparison||0.103|-0.084|0.8451
91618664|NCT02175771|183130582|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|-0.013|STANDARD_ERROR_OF_MEAN|0.0479||0.7877|TWO_SIDED|95.0|-0.107|0.081|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|High-strength comparison||0.081|-0.107|0.7877
91658276|NCT01706926|183210106|SUPERIORITY_OR_OTHER||Percent difference|3.8||||0.207|TWO_SIDED|95.0|-1.6|9.2|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||9.2|-1.6|0.207
91658277|NCT01706926|183210107|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
91524582|NCT02799472|182923997|OTHER||Mean Difference (Net)|-1536.0||||0.352|TWO_SIDED|95.0|-4884.2|1812.1|||Repeated measures analysis|||12-Week FU||1812.1|-4884.2|0.352
91524583|NCT02799472|182923998|OTHER||Mean Difference (Net)|0.0128||||0.291|TWO_SIDED|95.0|-0.0123|0.038|||Repeated measures analysis|||Week 4||0.0380|-0.0123|0.291
91658278|NCT01706926|183210107|SUPERIORITY_OR_OTHER||Percent difference|2.3||||0.621|TWO_SIDED|95.0|-2.3|6.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||6.9|-2.3|0.621
91658279|NCT01706926|183210107|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.062|TWO_SIDED|95.0|0.0|12.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||12.7|0.0|0.062
91658280|NCT01706926|183210108|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.245|TWO_SIDED|95.0|-0.4|7.8|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||7.8|-0.4|0.245
91658281|NCT01706926|183210108|SUPERIORITY_OR_OTHER||Percent difference|1.2||||1|TWO_SIDED|95.0|-1.1|3.5|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.5|-1.1|1.000
91658282|NCT01706926|183210108|SUPERIORITY_OR_OTHER||Percent difference|1.3||||0.494|TWO_SIDED|95.0|-1.2|3.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.7|-1.2|0.494
91658283|NCT01706926|183210109|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.608||0.463|TWO_SIDED|95.0|-1.99|4.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||4.35|-1.99|0.463
91658284|NCT01706926|183210109|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.27|STANDARD_ERROR_OF_MEAN|1.574||0.151|TWO_SIDED|95.0|-0.83|5.37|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||5.37|-0.83|0.151
91658285|NCT01706926|183210109|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.92|STANDARD_ERROR_OF_MEAN|1.578||0.014|TWO_SIDED|95.0|0.81|7.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||7.02|0.81|0.014
91658286|NCT00722124|183210121|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.615
91524584|NCT02799472|182923998|OTHER||Mean Difference (Net)|0.0036||||0.375|TWO_SIDED|95.0|-0.0046|0.0118|||Repeated measures analysis|||Week 12||0.0118|-0.0046|0.375
91658287|NCT00722124|183210121|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.826
91658288|NCT00358449|183210181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.865|TWO_SIDED|95.0|0.04|5.44|||Regression, Logistic|||||5.44|0.04|0.865
91658289|NCT00358449|183210181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.19|TWO_SIDED|95.0|0.01|2.07|||Regression, Logistic|||||2.07|0.01|0.190
91658290|NCT00358449|183210184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.551|TWO_SIDED|95.0|-0.303|0.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.560|-0.303|0.551
91658291|NCT00358449|183210184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.593||95.0|-0.331|0.572|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.572|-0.331|0.593
91658292|NCT00358449|183210184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334||||0.239|TWO_SIDED|95.0|-0.232|0.901|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.901|-0.232|0.239
91658293|NCT00358449|183210184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211||||0.488|TWO_SIDED|95.0|-0.401|0.823|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.823|-0.401|0.488
91658294|NCT00358449|183210185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.139|TWO_SIDED|95.0|-0.121|0.833|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.833|-0.121|0.139
91658295|NCT00358449|183210185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.371||||0.145||95.0|-0.133|0.874|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.874|-0.133|0.145
91658296|NCT00358449|183210185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433||||0.095|TWO_SIDED|95.0|-0.08|0.946|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.946|-0.080|0.095
91658297|NCT00358449|183210185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.343||||0.219|TWO_SIDED|95.0|-0.214|0.899|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.899|-0.214|0.219
91658298|NCT00358449|183210186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.832|TWO_SIDED|95.0|-13.47|16.65|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||16.65|-13.47|0.832
91658299|NCT00358449|183210186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.92||||0.622|TWO_SIDED|95.0|-12.01|19.84|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||19.84|-12.01|0.622
91658300|NCT00358449|183210186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.83||||0.317|TWO_SIDED|95.0|-11.86|35.52|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||35.52|-11.86|0.317
91658301|NCT00358449|183210186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.246|TWO_SIDED|95.0|-10.91|41.11|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||41.11|-10.91|0.246
91658302|NCT00358449|183210187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.28||||0.046|TWO_SIDED|95.0|0.39|38.18|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||38.18|0.39|0.046
91658303|NCT00358449|183210187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.21||||0.16|TWO_SIDED|95.0|-5.83|34.25|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||34.25|-5.83|0.160
91658304|NCT00358449|183210187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.69||||0.078|TWO_SIDED|95.0|-2.1|37.48|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.48|-2.10|0.078
91658305|NCT00358449|183210187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.11||||0.055|TWO_SIDED|95.0|-0.51|42.74|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||42.74|-0.51|0.055
91658306|NCT00358449|183210188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324||||0.241|TWO_SIDED|95.0|-0.226|0.873|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.873|-0.226|0.241
91658307|NCT00358449|183210188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.371|TWO_SIDED|95.0|-0.32|0.839|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.839|-0.320|0.371
91658308|NCT00358449|183210188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353||||0.291|TWO_SIDED|95.0|-0.317|1.023|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.023|-0.317|0.291
91618665|NCT02175771|183130582|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.0485||0.9966|TWO_SIDED|95.0|-0.095|0.095|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||0.095|-0.095|0.9966
91618666|NCT02175771|183130582|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.059|STANDARD_ERROR_OF_MEAN|0.0464||0.2056|TWO_SIDED|95.0|-0.032|0.15|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|High-strength comparison||0.150|-0.032|0.2056
91524585|NCT02799472|182923998|OTHER||Mean Difference (Net)|0.001||||0.588|TWO_SIDED|95.0|-0.0028|0.0049|||Repeated measures analysis|||12-Week FU||0.0049|-0.0028|0.588
91524586|NCT02799472|182923999|OTHER||Mean Difference (Net)|-0.0002||||0.915|TWO_SIDED|95.0|-0.0033|0.0029|||Repeated measures analysis|||Week 4||0.0029|-0.0033|0.915
91524587|NCT02799472|182923999|OTHER||Mean Difference (Net)|-0.0004||||0.771|TWO_SIDED|95.0|-0.0028|0.0021|||Repeated measures analysis|||Week 12||0.0021|-0.0028|0.771
91618667|NCT00543569|183130593|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|13.6|||||TWO_SIDED|90.0|3.2|23.9|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||23.9|3.2|
91618668|NCT00543569|183130593|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||15.8|-3.6|
91618669|NCT00543569|183130593|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3|||||A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||13.3|-5.3|
91618670|NCT00543569|183130594|SUPERIORITY_OR_OTHER||Difference|-1.4|||||TWO_SIDED|90.0|-6.9|4.1||||||Patient survival at 6 months||4.1|-6.9|
91618671|NCT00543569|183130594|SUPERIORITY_OR_OTHER||Difference|1.1|||||TWO_SIDED|90.0|-3.5|5.8||||||Patient survival at 6 months||5.8|-3.5|
91618672|NCT00543569|183130594|SUPERIORITY_OR_OTHER||Difference|-2.6|||||TWO_SIDED|90.0|-8.4|3.2||||||Patient survival at 6 months||3.2|-8.4|
91618673|NCT00543569|183130594|SUPERIORITY_OR_OTHER||Difference|4.9|||||TWO_SIDED|90.0|-3.1|12.8||||||Patient survival at 12 months||12.8|-3.1|
91618674|NCT00543569|183130594|SUPERIORITY_OR_OTHER||Difference|0.5|||||TWO_SIDED|90.0|-8.3|9.2||||||Patient survival at 12 months||9.2|-8.3|
91618675|NCT00543569|183130594|SUPERIORITY_OR_OTHER||Difference|2.4|||||TWO_SIDED|90.0|-6.0|10.8||||||Patient survival at 12 months||10.8|-6.0|
91618676|NCT00543569|183130595|SUPERIORITY_OR_OTHER||Difference|-2.7|||||TWO_SIDED|90.0|-8.5|3.1||||||Graft survival at 6 months||3.1|-8.5|
91618677|NCT00543569|183130595|SUPERIORITY_OR_OTHER||Difference|-0.2|||||TWO_SIDED|90.0|-5.3|4.9||||||Graft survival at 6 months||4.9|-5.3|
91618678|NCT00543569|183130595|SUPERIORITY_OR_OTHER||Difference|-3.9|||||TWO_SIDED|90.0|-10.0|2.2||||||Graft survival at 6 months||2.2|-10.0|
91618679|NCT00543569|183130595|SUPERIORITY_OR_OTHER||Difference|3.6|||||TWO_SIDED|90.0|-4.6|11.7||||||Graft survival at 12 months||11.7|-4.6|
91618680|NCT00543569|183130595|SUPERIORITY_OR_OTHER||Difference|-0.9|||||TWO_SIDED|90.0|-9.9|8.1||||||Graft survival at 12 months||8.1|-9.9|
91618681|NCT00543569|183130595|SUPERIORITY_OR_OTHER||Difference|-1.6|||||TWO_SIDED|90.0|-10.6|7.4||||||Graft survival at 12 months||7.4|-10.6|
91618682|NCT00543569|183130596|SUPERIORITY_OR_OTHER||Difference|13.7|||||TWO_SIDED|90.0|2.8|24.6||||||||24.6|2.8|
91618683|NCT00543569|183130596|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.4|15.0||||||||15.0|-5.4|
91618684|NCT00543569|183130596|SUPERIORITY_OR_OTHER||Difference|2.8|||||TWO_SIDED|90.0|-7.1|12.6||||||||12.6|-7.1|
91618685|NCT00543569|183130597|SUPERIORITY_OR_OTHER||Difference|10.6|||||TWO_SIDED|90.0|1.8|19.5||||||BCAR at Month 6||19.5|1.8|
91618686|NCT00543569|183130597|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 6||12.3|-3.6|
91618687|NCT00543569|183130597|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||BCAR at Month 6||14.6|-1.7|
91618688|NCT00543569|183130597|SUPERIORITY_OR_OTHER||Difference|12.0|||||TWO_SIDED|90.0|3.0|21.0||||||BCAR at Month 12||21.0|3.0|
91618689|NCT00543569|183130597|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 12||12.3|-3.6|
91791586|NCT03274999|183460933|SUPERIORITY|||||||0.034||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.034
91658309|NCT00358449|183210188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.653|TWO_SIDED|95.0|-0.965|0.614|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.614|-0.965|0.653
91658310|NCT00358449|183210189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.06||||0.123|TWO_SIDED|95.0|-4.0|32.13|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||32.13|-4.00|0.123
91658311|NCT00358449|183210189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62||||0.551|TWO_SIDED|95.0|-13.29|24.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||24.54|-13.29|0.551
91658312|NCT00358449|183210189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.141|TWO_SIDED|95.0|-5.61|37.7|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.70|-5.61|0.141
91658313|NCT00358449|183210189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42||||0.666|TWO_SIDED|95.0|-30.74|19.9|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||19.90|-30.74|0.666
91658314|NCT00358449|183210190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.572|TWO_SIDED|95.0|-0.224|0.4|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.400|-0.224|0.572
91658315|NCT00358449|183210190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.942|TWO_SIDED|95.0|-0.35|0.326|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.326|-0.350|0.942
91658316|NCT00358449|183210190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.96|TWO_SIDED|95.0|-0.188|0.197|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.197|-0.188|0.960
91658317|NCT00358449|183210190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.317|TWO_SIDED|95.0|-0.105|0.315|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.315|-0.105|0.317
91658318|NCT00358449|183210191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.666|TWO_SIDED|95.0|-6.39|4.12|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||4.12|-6.39|0.666
91791587|NCT03274999|183460933|SUPERIORITY|||||||0.143||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.143
91524588|NCT02799472|182923999|OTHER||Mean Difference (Net)|0.0005||||0.85|TWO_SIDED|95.0|-0.0048|0.0058|||Repeated measures analysis|||12-Week FU||0.0058|-0.0048|0.850
91658319|NCT00358449|183210191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.45|TWO_SIDED|95.0|-7.87|3.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.56|-7.87|0.450
91658320|NCT00358449|183210191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.215|TWO_SIDED|95.0|-12.0|2.81|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||2.81|-12.00|0.215
91658321|NCT00358449|183210191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.898|TWO_SIDED|95.0|-8.61|7.58|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||7.58|-8.61|0.898
91658322|NCT00358449|183210192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.762|TWO_SIDED|95.0|-0.217|0.294|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.294|-0.217|0.762
91658323|NCT00358449|183210192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.235|TWO_SIDED|95.0|-0.426|0.108|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.108|-0.426|0.235
91658324|NCT00358449|183210192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.607|TWO_SIDED|95.0|-0.259|0.436|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.436|-0.259|0.607
91658325|NCT00358449|183210192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068||||0.716|TWO_SIDED|95.0|-0.308|0.443|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.443|-0.308|0.716
91658326|NCT00358449|183210193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.691|TWO_SIDED|95.0|-0.365|0.545|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.545|-0.365|0.691
91658327|NCT00358449|183210193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.5|TWO_SIDED|95.0|-0.639|0.317|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.317|-0.639|0.500
91658328|NCT00358449|183210193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.568|TWO_SIDED|95.0|-0.474|0.849|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.849|-0.474|0.568
91658329|NCT00358449|183210193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076||||0.832|TWO_SIDED|95.0|-0.643|0.794|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.794|-0.643|0.832
91658330|NCT00358449|183210194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.515|TWO_SIDED|95.0|-3.45|1.76|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.76|-3.45|0.515
91658331|NCT00358449|183210194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.496|TWO_SIDED|95.0|-1.74|3.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.54|-1.74|0.496
91791588|NCT03274999|183460933|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
91791589|NCT03274999|183460933|SUPERIORITY|||||||0.25||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.250
91791590|NCT03274999|183460933|SUPERIORITY|||||||0.09||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
91658332|NCT00358449|183210194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.657|TWO_SIDED|95.0|-5.82|3.72|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||3.72|-5.82|0.657
91618690|NCT00543569|183130597|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||BCAR at Month 12||16.2|-0.6|
91618691|NCT00543569|183130598|SUPERIORITY_OR_OTHER||Difference|12.2|||||TWO_SIDED|90.0|2.0|22.5||||||T-cell Mediated BCAR at Month 6||22.5|2.0|
91618692|NCT00543569|183130598|SUPERIORITY_OR_OTHER||Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8||||||T-cell Mediated BCAR at Month 6||15.8|-3.6|
91618693|NCT00543569|183130598|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3||||||T-cell Mediated BCAR at Month 6||13.3|-5.3|
91618694|NCT00543569|183130598|SUPERIORITY_OR_OTHER||Difference|13.6|||||TWO_SIDED|90.0|3.0|24.3||||||T-cell Mediated BCAR at Month 12||24.3|3.0|
91618695|NCT00543569|183130598|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.1|14.6||||||T-cell Mediated BCAR at Month 12||14.6|-5.1|
91618696|NCT00543569|183130598|SUPERIORITY_OR_OTHER||Difference|4.1|||||TWO_SIDED|90.0|-5.6|13.8||||||T-cell Mediated BCAR at Month 12||13.8|-5.6|
91618697|NCT00543569|183130599|SUPERIORITY_OR_OTHER||Difference|9.3|||||TWO_SIDED|90.0|0.7|18.0||||||T-cell Mediated BCAR at Month 6||18.0|0.7|
91618698|NCT00543569|183130599|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 6||12.3|-3.6|
91618699|NCT00543569|183130599|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||T-cell Mediated BCAR at Month 6||14.6|-1.7|
91618700|NCT00543569|183130599|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|1.8|19.5||||||T-cell Mediated BCAR at Month 12||19.5|1.8|
91618701|NCT00543569|183130599|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 12||12.3|-3.6|
91618702|NCT00543569|183130599|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||T-cell Mediated BCAR at Month 12||16.2|-0.6|
91618703|NCT00543569|183130603|SUPERIORITY_OR_OTHER||Difference|14.7|||||TWO_SIDED|90.0|3.8|25.5||||||Efficacy Failure at Month 6||25.5|3.8|
91618704|NCT00543569|183130603|SUPERIORITY_OR_OTHER||Difference|7.5|||||TWO_SIDED|90.0|-2.9|17.8||||||Efficacy Failure at Month 6||17.8|-2.9|
91618705|NCT00543569|183130603|SUPERIORITY_OR_OTHER||Difference|7.9|||||TWO_SIDED|90.0|-2.4|18.2||||||Efficacy Failure at Month 6||18.2|-2.4|
91618706|NCT00543569|183130603|SUPERIORITY_OR_OTHER||Difference|8.4|||||TWO_SIDED|90.0|-3.5|20.4||||||Efficacy Failure at Month12||20.4|-3.5|
91618707|NCT00543569|183130603|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-7.8|15.8||||||Efficacy Failure at Month 12||15.8|-7.8|
91658333|NCT00358449|183210194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.691|TWO_SIDED|95.0|-6.11|4.09|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.09|-6.11|0.691
91658334|NCT00358449|183210195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.142|TWO_SIDED|95.0|-0.105|0.704|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.704|-0.105|0.142
91658335|NCT00358449|183210195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354||||0.115|TWO_SIDED|95.0|-0.09|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.798|-0.090|0.115
91658336|NCT00358449|183210195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.465|TWO_SIDED|95.0|-0.319|0.683|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.683|-0.319|0.465
91658337|NCT00358449|183210195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.649|TWO_SIDED|95.0|-0.417|0.66|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.660|-0.417|0.649
91658338|NCT00358449|183210196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.077|TWO_SIDED|95.0|-0.042|0.782|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.782|-0.042|0.077
91712946|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.43|||||TWO_SIDED|95.0|0.85|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.85|
91712947|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.68|1.56|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.56|0.68|
91712948|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.83|1.92|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.92|0.83|
91791591|NCT03274999|183460933|SUPERIORITY|||||||0.328||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
91791592|NCT03274999|183460933|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
91524589|NCT02801669|182924000|OTHER||Cox Proportional Hazard|0.339||||0.0003|TWO_SIDED|95.0|0.188|0.608|||Regression, Cox|The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.||This statistical analysis assesses the annual incidence of composite event of stroke and SEE between treatment groups.||0.608|0.188|0.0003
91524590|NCT02801669|182924001|OTHER||Cox Proportional Hazard|0.299|||||TWO_SIDED|95.0|0.157|0.57|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of stroke between treatment groups.||0.570|0.157|
91524591|NCT02801669|182924001|OTHER||Cox Proportional Hazard|0.503|||||TWO_SIDED|95.0|0.126|2.011|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of SEE between treatment groups.||2.011|0.126|
91658339|NCT00358449|183210196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.12|TWO_SIDED|95.0|-0.097|0.809|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.809|-0.097|0.120
91658340|NCT00358449|183210196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.345|TWO_SIDED|95.0|-0.326|0.906|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.906|-0.326|0.345
91658341|NCT00358449|183210196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.7|TWO_SIDED|95.0|-0.541|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.798|-0.541|0.700
91658342|NCT00358449|183210197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.609|TWO_SIDED|95.0|-8.79|5.22|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||5.22|-8.79|0.609
91658343|NCT00358449|183210197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.882|TWO_SIDED|95.0|-8.55|7.38|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||7.38|-8.55|0.882
91658344|NCT00358449|183210197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.595|TWO_SIDED|95.0|-7.68|4.47|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.47|-7.68|0.595
91658345|NCT00358449|183210197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.895|TWO_SIDED|95.0|-7.34|6.44|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||6.44|-7.34|0.895
91658346|NCT00358449|183210198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.513||||0.062|TWO_SIDED|95.0|-0.028|1.055|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.055|-0.028|0.062
91658347|NCT00358449|183210198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241||||0.425|TWO_SIDED|95.0|-0.369|0.852|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.852|-0.369|0.425
91658348|NCT00358449|183210198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.082|TWO_SIDED|95.0|-0.096|1.516|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.516|-0.096|0.082
91658349|NCT00358449|183210198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.564|TWO_SIDED|95.0|-0.631|1.132|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.132|-0.631|0.564
91658350|NCT00358449|183210199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.27|TWO_SIDED|95.0|-7.77|26.67|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||26.67|-7.77|0.270
91658351|NCT00358449|183210199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||0.664|TWO_SIDED|95.0|-15.11|23.36|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||23.36|-15.11|0.664
91524592|NCT02801669|182924001|OTHER||Cox Proportional Hazard|0.306|||||TWO_SIDED|95.0|0.16|0.585|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke between treatment groups.||0.585|0.160|
91618708|NCT00543569|183130603|SUPERIORITY_OR_OTHER||Difference|4.2|||||TWO_SIDED|90.0|-7.5|15.9||||||Efficacy Failure at Month12||15.9|-7.5|
91618709|NCT00543569|183130604|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|0.9|20.4||||||Efficacy Failure at Month 6||20.4|0.9|
91618710|NCT00543569|183130604|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-4.5|13.7||||||Efficacy Failure at Month 6||13.7|-4.5|
91618711|NCT00543569|183130604|SUPERIORITY_OR_OTHER||Difference|9.1|||||TWO_SIDED|90.0|-0.4|18.7||||||Efficacy Failure at Month 6||18.7|-0.4|
91618712|NCT00543569|183130604|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|90.0|-4.0|18.0||||||Efficacy Failure at Month 12||18.0|-4.0|
91618713|NCT00543569|183130604|SUPERIORITY_OR_OTHER||Difference|2.3|||||TWO_SIDED|90.0|-8.3|13.0||||||Efficacy Failure at Month 12||13.0|-8.3|
91618714|NCT00543569|183130604|SUPERIORITY_OR_OTHER||Difference|6.7|||||TWO_SIDED|90.0|-4.2|17.6||||||Efficacy Failure at Month 12||17.6|-4.2|
91618715|NCT00543569|183130614|SUPERIORITY_OR_OTHER||Difference|11.1|||||TWO_SIDED|90.0|-1.1|23.3||||||Treatment Failure at Month 6||23.3|-1.1|
91618716|NCT00543569|183130614|SUPERIORITY_OR_OTHER||Difference|11.8|||||TWO_SIDED|90.0|-0.7|24.2||||||Treatment Failure at Month 6||24.2|-0.7|
91618717|NCT00543569|183130614|SUPERIORITY_OR_OTHER||Difference|2.9|||||TWO_SIDED|90.0|-8.9|14.7||||||Treatment Failure at Month 6||14.7|-8.9|
91618718|NCT00543569|183130614|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|90.0|-2.9|22.8||||||Treatment Failure at Month 12||22.8|-2.9|
91618719|NCT00543569|183130614|SUPERIORITY_OR_OTHER||Difference|9.7|||||TWO_SIDED|90.0|-3.3|22.8||||||Treatment Failure at Month 12||22.8|-3.3|
91618720|NCT00543569|183130614|SUPERIORITY_OR_OTHER||Difference|-0.8|||||TWO_SIDED|90.0|-13.3|11.7||||||Treatment Failure at Month 12||11.7|-13.3|
91618721|NCT00862849|183130621|SUPERIORITY_OR_OTHER||LS Mean Difference|26.47|||<|0.0001|TWO_SIDED|90.0|18.22|34.71||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||34.71|18.22|<0.0001
91618722|NCT00862849|183130621|SUPERIORITY_OR_OTHER||LS Mean Difference|16.7||||0.0015|TWO_SIDED|90.0|8.45|24.94||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed||||24.94|8.45|0.0015
91618723|NCT02344407|183130629|SUPERIORITY|||||||0.68|||||||Chi-squared|Bernards Exact Test Chi-square||Each active vaccine is compared to the placebo group||||0.68
91618724|NCT02344407|183130629|SUPERIORITY|||||||0.68|||||||Chi-squared|Barnard Exact Test Chi-square||||||0.68
91618725|NCT02344407|183130630|SUPERIORITY||||||<|0.001|||||||ANCOVA|Linear regression (analysis of covariance) adjusted for baseline antibody level||||||<0.001
91618726|NCT02344407|183130630|SUPERIORITY||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline antibody level||||||<0.001
91618727|NCT04124536|183130631|SUPERIORITY||Risk Difference (RD)|-21.9|||||TWO_SIDED|95.0|-35.9|-7.9|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-7.9|-35.9|
91618728|NCT04124536|183130631|SUPERIORITY||Risk Difference (RD)|-30.7|||||TWO_SIDED|95.0|-40.6|-20.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-20.8|-40.6|
91618729|NCT04124536|183130632|SUPERIORITY||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.6|2.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||2.8|-13.6|
91618730|NCT04124536|183130632|SUPERIORITY||||||||||||||||||The calculation of risk differences between study arms was originally planned. However, the linear-binomial model did not converge because of zero events in the intervention arm.|||
91618731|NCT04124536|183130636|SUPERIORITY||Risk Difference (RD)|40.7|||||TWO_SIDED|95.0|23.0|58.4|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||58.4|23.0|
91618732|NCT04124536|183130636|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|10.7|36.0|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||36.0|10.7|
91618733|NCT00677690|183130642|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||"All data were expressed as the mean ± SD. The level of significance for all tests was set at p \< 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables."||||< 0.05
91618734|NCT00677690|183130643|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
91618735|NCT00677690|183130644|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
91618736|NCT00677690|183130645|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
91618737|NCT00677690|183130646|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
91618738|NCT01842620|183130670|EQUIVALENCE|Geometric means ratio for AUC (0-t) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-36)*100|100.0|||||TWO_SIDED|90.0|92.62|107.98|||||Ratio of AUC0-36= (AUC0-36 of Test)/ AUC 0-36 Reference)|Overall period||107.98|92.62|
91712949|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.73|1.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.63|0.73|
91658352|NCT00358449|183210199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57||||0.381|TWO_SIDED|95.0|-13.81|34.94|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||34.94|-13.81|0.381
91658353|NCT00358449|183210199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49||||0.672|TWO_SIDED|95.0|-20.87|31.86|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||31.86|-20.87|0.672
91658354|NCT00358449|183210200|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Cochran-Mantel-Haenszel|||||||0.400
91658355|NCT00358449|183210200|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Cochran-Mantel-Haenszel|||||||0.111
91658356|NCT00358449|183210201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.421|TWO_SIDED|95.0|-71.1|34.4|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||34.4|-71.1|0.421
91658357|NCT00358449|183210201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.633|TWO_SIDED|95.0|-44.6|40.5|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||40.5|-44.6|0.633
91658358|NCT00358449|183210201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3||||0.92|TWO_SIDED|95.0|-76.3|45.7|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||45.7|-76.3|0.920
91658359|NCT00358449|183210201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.8||||0.105|TWO_SIDED|95.0|-79.2|11.6|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||11.6|-79.2|0.105
91658360|NCT00358449|183210202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.747|TWO_SIDED|95.0|-20.68|15.41|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||15.41|-20.68|0.747
91658361|NCT00358449|183210202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.352|TWO_SIDED|95.0|-24.41|11.01|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||11.01|-24.41|0.352
91658362|NCT00358449|183210202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.25||||0.525|TWO_SIDED|95.0|-29.69|11.2|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 24|||11.20|-29.69|0.525
91658363|NCT00358449|183210202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.79||||0.071|TWO_SIDED|95.0|-35.21|-0.38|||Van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline at week 24|||-0.38|-35.21|0.071
91658364|NCT02334722|183210213|SUPERIORITY||Median Difference (Final Values)|-2.5||||0.7824|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7824
91712950|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|0.85|||||TWO_SIDED|95.0|0.56|1.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.29|0.56|
91712951|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.55|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.23|0.55|
91658365|NCT03988803|183210214|OTHER||Ratio of the geometric means (T/R1)|94.8|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|90.0|87.14|103.14|||ANOVA||Standard error of the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.14|87.14|
91658366|NCT03988803|183210215|OTHER||Ratio of the geometric means (T/R1)|99.34|STANDARD_ERROR_OF_MEAN|12.3|||TWO_SIDED|90.0|91.22|108.18|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||108.18|91.22|
91658367|NCT03988803|183210216|OTHER||Ratio of the geometric means (T/R2)|103.69|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|99.99|107.52|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||107.52|99.99|
91658368|NCT03988803|183210217|OTHER||Ratio of the geometric means (T/R2)|107.45|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|102.66|112.45|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||112.45|102.66|
91658369|NCT01171690|183210232|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Matched pairs t test|||Matched pairs||||0.01
91658370|NCT02087904|183210242|SUPERIORITY||LS Mean Difference|-0.3||||0.834|TWO_SIDED|95.0|-3.13|2.53||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and Kellgren-Lawrence (K-L) grade as the main factors and baseline as a covariate.|ANCOVA|||||2.53|-3.13|0.834
91658371|NCT02087904|183210242|SUPERIORITY||LS Mean Difference|-2.9||||0.05|TWO_SIDED|95.0|-5.73|0.01||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.01|-5.73|0.05
91658372|NCT02087904|183210242|SUPERIORITY||LS Mean Difference|-1.2||||0.415|TWO_SIDED|95.0|-4.0|1.66||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.66|-4.00|0.415
91658373|NCT02087904|183210243|SUPERIORITY||LS Mean Difference|0.06||||0.145|TWO_SIDED|95.0|-0.021|0.141||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.141|-0.021|0.145
91658374|NCT02087904|183210243|SUPERIORITY||LS Mean Difference|-0.03||||0.52|TWO_SIDED|95.0|-0.11|0.056||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.056|-0.11|0.52
91658375|NCT02087904|183210243|SUPERIORITY||LS Mean Difference|0.06||||0.159|TWO_SIDED|95.0|-0.023|0.139||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.139|-0.023|0.159
91658376|NCT02087904|183210244|SUPERIORITY||LS Mean Difference|0.22||||0.897|TWO_SIDED|95.0|-3.193|3.642||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||3.642|-3.193|0.897
91658377|NCT02087904|183210244|SUPERIORITY||LS Mean Difference|-1.07||||0.542|TWO_SIDED|95.0|-4.515|2.377||P-value for test of difference between ABT-981 100 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.377|-4.515|0.542
91658378|NCT02087904|183210244|SUPERIORITY||LS Mean Difference|-1.52||||0.385|TWO_SIDED|95.0|-4.95|1.916||P-value for test of difference between ABT-981 200 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.916|-4.95|0.385
91658379|NCT02087904|183210245|SUPERIORITY||LS Mean Difference|-0.08||||0.384|TWO_SIDED|95.0|-0.249|0.096||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.096|-0.249|0.384
91658380|NCT02087904|183210245|SUPERIORITY||LS Mean Difference|-0.15||||0.095|TWO_SIDED|95.0|-0.324|0.026||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.026|-0.324|0.095
91658381|NCT02087904|183210245|SUPERIORITY||LS Mean Difference|-0.14||||0.106|TWO_SIDED|95.0|-0.314|0.03||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.03|-0.314|0.106
91712952|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.66|||||TWO_SIDED|95.0|0.89|3.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.11|0.89|
91712953|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.52|||||TWO_SIDED|95.0|0.83|2.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.77|0.83|
91712954|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.78|2.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.71|0.78|
91712955|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.28|||||TWO_SIDED|95.0|0.7|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.34|0.70|
91791593|NCT03274999|183460933|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
91658382|NCT02087904|183210246|SUPERIORITY||LS Mean Difference|-1.1||||0.818|TWO_SIDED|95.0|-10.22|8.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||8.08|-10.22|0.818
91658383|NCT02087904|183210246|SUPERIORITY||LS Mean Difference|-7.6||||0.109|TWO_SIDED|95.0|-16.83|1.69||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.69|-16.83|0.109
91658384|NCT02087904|183210246|SUPERIORITY||LS Mean Difference|-3.4||||0.465|TWO_SIDED|95.0|-12.58|5.76||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.76|-12.58|0.465
91658385|NCT02087904|183210247|SUPERIORITY||LS Mean Difference|-2.1||||0.666|TWO_SIDED|95.0|-11.76|7.52||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.52|-11.76|0.666
91658386|NCT02087904|183210247|SUPERIORITY||LS Mean Difference|-9.2||||0.065|TWO_SIDED|95.0|-18.95|0.56||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.56|-18.95|0.065
91618739|NCT01842620|183130671|EQUIVALENCE|Geometric means ratio for AUC(0-inf) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-inf)*100|99.02|||||TWO_SIDED|90.0|92.26|106.27|||||Ratio of AUC0-inf= (AUC0-inf of Test) / (AUC 0-inf of Reference)|For overall period||106.27|92.26|
91618740|NCT01842620|183130672|EQUIVALENCE|Geometric means ratio for Cmax of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of Cmax)*100|98.34|||||TWO_SIDED|90.0|88.54|109.22|||||Ratio of Cmax= (Cmax of Test) / (Cmax of Reference)|Overall period||109.22|88.54|
91618741|NCT02371759|183130676|NON_INFERIORITY_OR_EQUIVALENCE|In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group||||<0.05
91618742|NCT02371759|183130677|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91618743|NCT02371759|183130693|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91618744|NCT02371759|183130694|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91618745|NCT02371759|183130695|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91618746|NCT02371759|183130696|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91618747|NCT02371759|183130697|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91618748|NCT02371759|183130698|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91618749|NCT02371759|183130699|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91618750|NCT02371759|183130700|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91524593|NCT02801669|182924001|OTHER||Cox Proportional Hazard|0.347|||||TWO_SIDED|95.0|0.193|0.624|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke/SEE between treatment groups.||0.624|0.193|
91618751|NCT02322320|183130701|SUPERIORITY|||||||0.6||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.60
91618752|NCT02322320|183130701|SUPERIORITY|||||||0.35||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.35
91618753|NCT02322320|183130701|SUPERIORITY|||||||0.68||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.68
91618754|NCT02322320|183130702|SUPERIORITY|||||||0.57||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.57
91618755|NCT02322320|183130702|SUPERIORITY|||||||0.38||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.38
91618756|NCT02322320|183130702|SUPERIORITY|||||||0.77||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.77
91618757|NCT02322320|183130703|SUPERIORITY|||||||0.67||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.67
91618758|NCT02322320|183130703|SUPERIORITY|||||||0.2||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.20
91658387|NCT02087904|183210247|SUPERIORITY||LS Mean Difference|-7.2||||0.145|TWO_SIDED|95.0|-16.84|2.49||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.49|-16.84|0.145
91658388|NCT02087904|183210248|SUPERIORITY||LS Mean Difference|-3.2||||0.558|TWO_SIDED|95.0|-14.03|7.59||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.59|-14.03|0.558
91658389|NCT02087904|183210248|SUPERIORITY||LS Mean Difference|-5.8||||0.295|TWO_SIDED|95.0|-16.77|5.11||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.11|-16.77|0.295
91618759|NCT02322320|183130703|SUPERIORITY|||||||0.4||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.40
91524594|NCT00615264|182924018|SUPERIORITY_OR_OTHER|||||||0.2851|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.2851
91658390|NCT02087904|183210248|SUPERIORITY||LS Mean Difference|-6.8||||0.218|TWO_SIDED|95.0|-17.63|4.04||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||4.04|-17.63|0.218
91658391|NCT02087904|183210249|SUPERIORITY||LS Mean Difference|-0.6||||0.664|TWO_SIDED|95.0|-3.58|2.28||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.28|-3.58|0.664
91658392|NCT02087904|183210249|SUPERIORITY||LS Mean Difference|-2.7||||0.075|TWO_SIDED|95.0|-5.67|0.28||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.28|-5.67|0.075
91658393|NCT02087904|183210249|SUPERIORITY||LS Mean Difference|-2.4||||0.107|TWO_SIDED|95.0|-5.33|0.52||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.52|-5.33|0.107
91658394|NCT02087904|183210250|SUPERIORITY||LS Mean Difference|0.5||||0.5|TWO_SIDED|95.0|-4.26|2.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.08|-4.26|0.5
91658395|NCT02087904|183210250|SUPERIORITY||LS Mean Difference|-2.2||||0.186|TWO_SIDED|95.0|-5.39|1.05||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.05|-5.39|0.186
91658396|NCT02087904|183210250|SUPERIORITY||LS Mean Difference|-2.3||||0.157|TWO_SIDED|95.0|-5.46|0.88||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.88|-5.46|0.157
91658397|NCT02087904|183210251|SUPERIORITY||LS Mean Difference|0.2||||0.319|TWO_SIDED|95.0|-0.23|0.69||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.69|-0.23|0.319
91658398|NCT02087904|183210251|SUPERIORITY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.6|0.33||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.33|-0.6|0.564
91618760|NCT02322320|183130704|SUPERIORITY|||||||0.43||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.43
91618761|NCT02322320|183130704|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.70
91658399|NCT02087904|183210251|SUPERIORITY||LS Mean Difference|0.0||||0.966|TWO_SIDED|95.0|-0.45|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.47|-0.45|0.966
91658400|NCT02087904|183210252|SUPERIORITY||LS Mean Difference|0.1||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.7|-0.41|0.602
91658401|NCT02087904|183210252|SUPERIORITY||LS Mean Difference|0.0||||0.953|TWO_SIDED|95.0|-0.55|0.58||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.58|-0.55|0.953
91658402|NCT02087904|183210252|SUPERIORITY||LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-0.61|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.61|0.83
91658403|NCT02087904|183210253|SUPERIORITY||LS Mean Difference|0.7||||0.804|TWO_SIDED|95.0|-4.91|6.33||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.33|-4.91|0.804
91658404|NCT02087904|183210253|SUPERIORITY||LS Mean Difference|-1.1||||0.699|TWO_SIDED|95.0|-6.9|4.63||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.63|-6.9|0.699
91658405|NCT02087904|183210253|SUPERIORITY||LS Mean Difference|1.4||||0.636|TWO_SIDED|95.0|-4.37|7.14||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||7.14|-4.37|0.636
91658406|NCT02087904|183210253|SUPERIORITY||LS Mean Difference|0.9||||0.756|TWO_SIDED|95.0|-4.91|6.76||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||6.76|-4.91|0.756
91658407|NCT02087904|183210253|SUPERIORITY||LS Mean Difference|-5.6||||0.068|TWO_SIDED|95.0|-11.55|0.42||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||0.42|-11.55|0.068
91524595|NCT00615264|182924019|SUPERIORITY_OR_OTHER|||||||0.769|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.7690
91618762|NCT02322320|183130704|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.70
91618763|NCT02876055|183130716|SUPERIORITY|||||||0.542|||||||Wilcoxon (Mann-Whitney)|||||||0.542
91618764|NCT02876055|183130716|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91618765|NCT02876055|183130716|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91618766|NCT04019093|183130738|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,46) = .001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.||||.99
91618767|NCT04019093|183130738|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,46)=12.55||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
91618768|NCT04019093|183130738|SUPERIORITY|||||||0.015|||||||ANOVA|F(1,46)=6.32||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.||||.015
91618769|NCT04019093|183130739|SUPERIORITY|||||||0.76|||||||ANOVA|F(2,82)=.20||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.||||.76
91618770|NCT04019093|183130739|SUPERIORITY|||||||0.52|||||||ANCOVA|F(2,82)=.66||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.||||.52
91618771|NCT04019093|183130739|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,41)=4.53, p=.04||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.||||.04
91618772|NCT04019093|183130739|SUPERIORITY|||||||0.017|||||||ANOVA|F(1,41)=6.24||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.||||.017
91658408|NCT02087904|183210253|SUPERIORITY||LS Mean Difference|-1.4||||0.649|TWO_SIDED|95.0|-7.34|4.58||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.58|-7.34|0.649
91658409|NCT02087904|183210254|SUPERIORITY||LS Mean Difference|-1.0||||0.75|TWO_SIDED|95.0|-7.14|5.14||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||5.14|-7.14|0.75
91618773|NCT04019093|183130739|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(2,82)=48.41||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.||||<.0001
91658410|NCT02087904|183210254|SUPERIORITY||LS Mean Difference|-2.6||||0.409|TWO_SIDED|95.0|-8.82|3.6||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.6|-8.82|0.409
91618774|NCT04019093|183130740|SUPERIORITY|||||||0.5|||||||ANOVA|F (2, 82) = 0.69||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.||||.50
91618775|NCT04019093|183130740|SUPERIORITY|||||||0.21|||||||ANOVA|F(2,82)=1.58||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.||||.21
91618776|NCT04019093|183130740|SUPERIORITY|||||||0.053|||||||ANOVA|F(2,82)=3.06||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.||||.053
91618777|NCT04019093|183130740|SUPERIORITY|||||||0.98|||||||ANOVA|F(1,41)=.001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.||||.98
91618778|NCT04019093|183130740|SUPERIORITY|||||||0.71|||||||ANOVA|F(2,82)=.34||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.||||.71
91618779|NCT04019093|183130740|SUPERIORITY|||||||0.71|||||||ANOVA|F(1,41)=.14||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.||||.71
91618780|NCT04019093|183130740|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,41)=55.02||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
91618781|NCT01067508|183130742|OTHER|||||||0.003||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to 12 weeks minus baseline change in Fiji water group||||0.003
91712956|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.78|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.28|0.78|
91712957|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.62|1.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.74|0.62|
91712958|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.62|1.82|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.82|0.62|
91618782|NCT01067508|183130742|OTHER|||||||0.68||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to the 12 week minus baseline change in Aquafina (control) group||||0.68
91618783|NCT00958308|183130743|SUPERIORITY_OR_OTHER||||||=|0.02|||||||Fisher Exact|||The sample size calculation was based on the incidence of AAD. A total of 255 patients was enrolled in order to obtain at least the required 225 evaluable patients.With expected AAD rates of at most 15% - 25% in the treatment groups; and 25% - 35% in the placebo group, these numbers were sufficient to detect the difference in the incidence of AAD between either of the treatment groups vs. placebo with a minimum of 86% statistical power.||||=0.02
91618784|NCT04030104|183130748|SUPERIORITY|||||||0.0268||||||Threshold for statistical significance \<0.05|Random Reader, Random Mass|Curve Fitting Method: Empirical||||||0.0268
91618785|NCT02065622|183130755|SUPERIORITY||Adjusted risk difference|2.5||||0.269|TWO_SIDED|95.0|-2.0|7.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.0|-2.0|0.269
91618786|NCT02065622|183130755|SUPERIORITY|||||||0.447|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.447
91618787|NCT02065622|183130755|SUPERIORITY||Adjusted risk difference|2.3||||0.301|TWO_SIDED|95.0|-2.0|6.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||6.6|-2.0|0.301
91618788|NCT02065622|183130755|SUPERIORITY|||||||0.502|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.502
91618789|NCT02065622|183130756|SUPERIORITY||Adjusted risk difference|9.9||||0.069|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.6|-0.8|0.069
91618790|NCT02065622|183130756|SUPERIORITY|||||||0.085|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.085
91712959|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.58|2.67|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.67|0.58|
91618791|NCT02065622|183130756|SUPERIORITY||Adjusted risk difference|10.3||||0.045|TWO_SIDED|95.0|0.2|20.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.4|0.2|0.045
91618792|NCT02065622|183130756|SUPERIORITY|||||||0.106|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.106
91524596|NCT02884414|182924024|OTHER|Paired Student's t-test.||||||0.44|||||||t-test, 2 sided|||||||0.44
91524597|NCT01982435|182924025|OTHER|Measures were summarized using means, range and standard error of the means (SEM).|||||<|0.05||||||Two-sided paired t-tests and two-sided unpaired t-tests were respectively conducted to analyze efficacy endpoints between study initiation to end, and between monthly and TAE injection regimens.|t-test, 2 sided|||All analyses were performed with a significance level of 0.05 being assumed for all tests.||||<0.05
91618793|NCT02065622|183130757|SUPERIORITY||Adjusted risk difference|4.2||||0.181|TWO_SIDED|95.0|-2.0|10.5|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.5|-2.0|0.181
91618794|NCT02065622|183130757|SUPERIORITY||Adjusted risk difference|3.8||||0.2|TWO_SIDED|95.0|-2.0|9.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||9.7|-2.0|0.200
91618795|NCT02065622|183130758|SUPERIORITY||Adjusted risk difference|3.0||||0.3|TWO_SIDED|95.0|-2.6|8.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.6|-2.6|0.300
91618796|NCT02065622|183130758|SUPERIORITY||Adjusted risk difference|3.1||||0.254|TWO_SIDED|95.0|-2.2|8.4|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.4|-2.2|0.254
91618797|NCT02065622|183130759|SUPERIORITY||Adjusted risk difference|6.5||||0.05|TWO_SIDED|95.0|0.0|13.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.1|-0.0|0.050
91618798|NCT02065622|183130759|SUPERIORITY||Adjusted risk difference|4.8||||0.131|TWO_SIDED|95.0|-1.4|11.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||11.0|-1.4|0.131
91618799|NCT02065622|183130760|SUPERIORITY||Adjusted risk difference|7.3||||0.035|TWO_SIDED|95.0|0.5|14.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.1|0.5|0.035
91618800|NCT02065622|183130760|SUPERIORITY||Adjusted risk difference|8.7||||0.008|TWO_SIDED|95.0|2.3|15.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||15.1|2.3|0.008
91618801|NCT02065622|183130761|SUPERIORITY||Adjusted risk difference|3.2||||0.16|TWO_SIDED|95.0|-1.3|7.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.6|-1.3|0.160
91618802|NCT02065622|183130761|SUPERIORITY||Adjusted risk difference|2.9||||0.166|TWO_SIDED|95.0|-1.2|7.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.1|-1.2|0.166
91618803|NCT02065622|183130762|SUPERIORITY||Adjusted risk difference|8.3||||0.011|TWO_SIDED|95.0|1.9|14.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.7|1.9|0.011
91618804|NCT02065622|183130762|SUPERIORITY||Adjusted risk difference|7.0||||0.025|TWO_SIDED|95.0|0.9|13.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.0|0.9|0.025
91618805|NCT02065622|183130763|SUPERIORITY||Adjusted risk difference|4.2||||0.218|TWO_SIDED|95.0|-2.5|10.9|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.9|-2.5|0.218
91618806|NCT02065622|183130763|SUPERIORITY||Adjusted risk difference|2.4||||0.456|TWO_SIDED|95.0|-4.0|8.8|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.8|-4.0|0.456
91618807|NCT02065622|183130764|SUPERIORITY||Adjusted risk difference|9.5||||0.098|TWO_SIDED|95.0|-1.7|20.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.8|-1.7|0.098
91618808|NCT02065622|183130764|SUPERIORITY||Adjusted risk difference|9.9||||0.066|TWO_SIDED|95.0|-0.7|20.5|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.5|-0.7|0.066
91658411|NCT02087904|183210254|SUPERIORITY||LS Mean Difference|-3.0||||0.338|TWO_SIDED|95.0|-9.24|3.18||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.18|-9.24|0.338
91658412|NCT02087904|183210254|SUPERIORITY||LS Mean Difference|0.7||||0.817|TWO_SIDED|95.0|-5.59|7.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||7.08|-5.59|0.817
91658413|NCT02087904|183210254|SUPERIORITY||LS Mean Difference|-2.0||||0.544|TWO_SIDED|95.0|-8.37|4.43||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.43|-8.37|0.544
91618809|NCT02065622|183130765|SUPERIORITY||Adjusted risk difference|21.5||||0.002|TWO_SIDED|95.0|7.6|35.4|||Cochran-Mantel-Haenszel|Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.||Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||35.4|7.6|0.002
91618810|NCT02065622|183130765|SUPERIORITY||Adjusted risk difference|19.7||||0.003|TWO_SIDED|95.0|6.6|32.7|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||32.7|6.6|0.003
91658414|NCT02087904|183210254|SUPERIORITY||LS Mean Difference|-2.5||||0.437|TWO_SIDED|95.0|-8.91|3.86||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||3.86|-8.91|0.437
91658415|NCT02087904|183210255|SUPERIORITY||LS Mean Difference|-2.2||||0.545|TWO_SIDED|95.0|-9.31|4.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.92|-9.31|0.545
91658416|NCT02087904|183210255|SUPERIORITY||LS Mean Difference|-0.4||||0.909|TWO_SIDED|95.0|-7.65|6.81||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.81|-7.65|0.909
91658417|NCT02087904|183210255|SUPERIORITY||LS Mean Difference|-4.0||||0.278|TWO_SIDED|95.0|-11.23|3.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.25|-11.23|0.278
91658418|NCT02087904|183210255|SUPERIORITY||LS Mean Difference|-1.2||||0.732|TWO_SIDED|95.0|-8.42|5.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||5.92|-8.42|0.732
91658419|NCT02087904|183210255|SUPERIORITY||LS Mean Difference|-4.6||||0.216|TWO_SIDED|95.0|-11.86|2.69||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||2.69|-11.86|0.216
91658420|NCT02087904|183210255|SUPERIORITY||LS Mean Difference|-9.2||||0.014|TWO_SIDED|95.0|-16.42|-1.88||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||-1.88|-16.42|0.014
91791594|NCT03274999|183460933|SUPERIORITY|||||||0.233||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.233
91791595|NCT03274999|183460934|SUPERIORITY|||||||0.072||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.072
91618811|NCT02065622|183130766|SUPERIORITY||Adjusted risk difference|11.5||||0.093|TWO_SIDED|95.0|-1.9|25.0|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.0|-1.9|0.093
91618812|NCT02065622|183130766|SUPERIORITY||Adjusted risk difference|11.1||||0.088|TWO_SIDED|95.0|-1.7|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-1.7|0.088
91618813|NCT02065622|183130767|SUPERIORITY||Adjusted risk difference|15.9||||0.161|TWO_SIDED|95.0|-6.3|38.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.2|-6.3|0.161
91618814|NCT02065622|183130767|SUPERIORITY||Adjusted risk difference|10.4||||0.312|TWO_SIDED|95.0|-9.8|30.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||30.6|-9.8|0.312
91618815|NCT02065622|183130768|SUPERIORITY||Adjusted risk difference|12.3||||0.272|TWO_SIDED|95.0|-9.7|34.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||34.4|-9.7|0.272
91618816|NCT02065622|183130768|SUPERIORITY||Adjusted risk difference|5.3||||0.6|TWO_SIDED|95.0|-14.6|25.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.2|-14.6|0.600
91618817|NCT02065622|183130769|SUPERIORITY||Adjusted risk difference|23.8||||0.074|TWO_SIDED|95.0|-2.3|49.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||49.9|-2.3|0.074
91618818|NCT02065622|183130769|SUPERIORITY||Adjusted risk difference|15.0||||0.21|TWO_SIDED|95.0|-8.5|38.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.4|-8.5|0.210
91618819|NCT02065622|183130770|SUPERIORITY||Adjusted risk difference|20.0||||0.151|TWO_SIDED|95.0|-7.3|47.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||47.3|-7.3|0.151
91618820|NCT02065622|183130770|SUPERIORITY||Adjusted risk difference|12.8||||0.299|TWO_SIDED|95.0|-11.3|36.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||36.8|-11.3|0.299
91618821|NCT02065622|183130771|SUPERIORITY||Adjusted risk difference|4.5||||0.422|TWO_SIDED|95.0|-6.4|15.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||15.3|-6.4|0.422
91618822|NCT02065622|183130771|SUPERIORITY||Adjusted risk difference|3.4||||0.513|TWO_SIDED|95.0|-6.8|13.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||13.6|-6.8|0.513
91618823|NCT02065622|183130772|SUPERIORITY||Adjusted risk difference|3.7||||0.351|TWO_SIDED|95.0|-4.1|11.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.4|-4.1|0.351
91791596|NCT03274999|183460934|SUPERIORITY|||||||0.297||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.297
91791597|NCT03274999|183460934|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
91618824|NCT02065622|183130772|SUPERIORITY||Adjusted risk difference|3.9||||0.292|TWO_SIDED|95.0|-3.3|11.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.1|-3.3|0.292
91618825|NCT02065622|183130773|SUPERIORITY||Adjusted risk difference|5.4||||0.121|TWO_SIDED|95.0|-1.4|12.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.1|-1.4|0.121
91618826|NCT02065622|183130773|SUPERIORITY||Adjusted risk difference|6.5||||0.046|TWO_SIDED|95.0|0.1|12.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.8|0.1|0.046
91618827|NCT02065622|183130774|SUPERIORITY||Adjusted risk difference|7.5||||0.159|TWO_SIDED|95.0|-2.9|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-2.9|0.159
91618828|NCT02065622|183130774|SUPERIORITY||Adjusted risk difference|8.0||||0.109|TWO_SIDED|95.0|-1.8|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-1.8|0.109
91618829|NCT02065622|183130775|SUPERIORITY||Adjusted risk difference|1.4||||0.903|TWO_SIDED|95.0|-21.0|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-21.0|0.903
91618830|NCT02065622|183130775|SUPERIORITY||Adjusted risk difference|1.3||||0.901|TWO_SIDED|95.0|-18.8|21.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||21.3|-18.8|0.901
91618831|NCT02065622|183130776|SUPERIORITY||Adjusted risk difference|7.7||||0.16|TWO_SIDED|95.0|-3.0|18.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.4|-3.0|0.160
91618832|NCT02065622|183130776|SUPERIORITY||Adjusted risk difference|9.1||||0.076|TWO_SIDED|95.0|-0.9|19.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||19.1|-0.9|0.076
91618833|NCT02065622|183130777|SUPERIORITY||Adjusted risk difference|7.3||||0.207|TWO_SIDED|95.0|-4.0|18.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.6|-4.0|0.207
91618834|NCT02065622|183130777|SUPERIORITY||Adjusted risk difference|4.2||||0.44|TWO_SIDED|95.0|-6.4|14.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||14.8|-6.4|0.440
91618835|NCT00488618|183130795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.9|-3.3|||ANCOVA||cariprazine - placebo|||-3.3|-8.9|<0.0001
91618836|NCT00488618|183130796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.0001|TWO_SIDED|95.0|-0.97|-0.32|||ANCOVA||cariprazine - placebo|||-0.32|-0.97|0.0001
91618837|NCT02207478|183130833|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.019
91618838|NCT02207478|183130834|SUPERIORITY_OR_OTHER|||||||0.843|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total procedure time||||0.843
91618839|NCT02207478|183130834|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total X-ray time||||0.233
91618840|NCT02207478|183130834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Duration time for finding lesions||||<0.001
91618841|NCT02207478|183130834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||X-ray time for finding lesions||||<0.001
91618842|NCT00333619|183130840|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANOVA|||||||0.10
91618843|NCT00333619|183130841|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
91658421|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.0||||0.874|TWO_SIDED|95.0|-0.56|0.66||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.66|-0.56|0.874
91618844|NCT03006471|183130876|SUPERIORITY|||||||0.755||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.755
91618845|NCT03006471|183130876|SUPERIORITY|||||||0.046||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.046
91658422|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|-0.2||||0.451|TWO_SIDED|95.0|-0.86|0.38||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.38|-0.86|0.451
91658423|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.3||||0.331|TWO_SIDED|95.0|-0.31|0.93||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.93|-0.31|0.331
91658424|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.0||||0.932|TWO_SIDED|95.0|-0.73|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-0.73|0.932
91658425|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|-0.3||||0.344|TWO_SIDED|95.0|-1.07|0.37||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.37|-1.07|0.344
91658426|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.3||||0.489|TWO_SIDED|95.0|-0.47|0.97||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.97|-0.47|0.489
91658427|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.2||||0.498|TWO_SIDED|95.0|-0.42|0.85||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.85|-0.42|0.498
91658428|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.2||||0.637|TWO_SIDED|95.0|-0.8|0.49||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.49|-0.8|0.637
91658429|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.3||||0.367|TWO_SIDED|95.0|-0.35|0.94||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.94|-0.35|0.367
91658430|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.1||||0.67|TWO_SIDED|95.0|-0.51|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.51|0.67
91712960|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|2.25|||||TWO_SIDED|95.0|1.09|4.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.63|1.09|
91712961|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.72|2.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.93|0.72|
91712962|NCT03311841|183317586|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.51|2.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.19|0.51|
91712963|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|0.63|||||TWO_SIDED|95.0|0.36|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.36|
91658431|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|-0.1||||0.776|TWO_SIDED|95.0|-0.76|0.57||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.76|0.776
91658432|NCT02087904|183210256|SUPERIORITY||LS Mean Difference|0.3||||0.387|TWO_SIDED|95.0|-0.37|0.96||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.96|-0.37|0.387
91658433|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.2||||0.661|TWO_SIDED|95.0|-0.86|0.54||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.54|-0.86|0.661
91658434|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.6||||0.122|TWO_SIDED|95.0|-1.26|0.15||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.15|-1.26|0.122
91618846|NCT03006471|183130877|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.752
91618847|NCT03006471|183130877|SUPERIORITY|||||||0.582||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.582
91618848|NCT03006471|183130878|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
91618849|NCT03006471|183130878|SUPERIORITY|||||||0.22||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.220
91618850|NCT03006471|183130879|SUPERIORITY|||||||0.624||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.624
91618851|NCT03006471|183130879|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||1.000
91618852|NCT03006471|183130880|SUPERIORITY|||||||0.906||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.906
91618853|NCT03006471|183130880|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.017
91618854|NCT03006471|183130881|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.454
91618855|NCT03006471|183130881|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.115
91618856|NCT03006471|183130882|SUPERIORITY|||||||0.422||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.422
91618857|NCT03006471|183130882|SUPERIORITY|||||||0.917||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.917
91618858|NCT03006471|183130883|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.650
91658435|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.2||||0.507|TWO_SIDED|95.0|-0.94|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.47|-0.94|0.507
91658436|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.85|0.74||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.74|-0.85|0.892
91658437|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.3||||0.433|TWO_SIDED|95.0|-1.12|0.48||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.48|-1.12|0.433
91618859|NCT03006471|183130883|SUPERIORITY|||||||0.108||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.108
91618860|NCT03006471|183130884|SUPERIORITY|||||||0.875||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.875
91618861|NCT03006471|183130884|SUPERIORITY|||||||0.196||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group||||0.196
91618862|NCT03006471|183130885|SUPERIORITY|||||||0.552||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.552
91618863|NCT03006471|183130885|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.087
91618864|NCT03006471|183130886|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
91524598|NCT03541044|182924041|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.91|1.0|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.00|0.91|
91524599|NCT03541044|182924042|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC(0-inf) fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.00|0.89|
91524600|NCT03541044|182924043|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.82|0.98|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||0.98|0.82|
91658438|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|0.0||||0.92|TWO_SIDED|95.0|-0.84|0.76||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.76|-0.84|0.92
91524601|NCT03315936|182924093|OTHER||geometric mean (gMean) ratio (T/R) %|110.31|||||TWO_SIDED|90.0|100.73|120.79|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually 12 subjects were analyzed||120.79|100.73|
91658439|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|0.0||||0.957|TWO_SIDED|95.0|-0.68|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.71|-0.68|0.957
91658440|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.4||||0.222|TWO_SIDED|95.0|-1.13|0.26||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.26|-1.13|0.222
91658441|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.4||||0.209|TWO_SIDED|95.0|-1.15|0.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.25|-1.15|0.209
91658442|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|0.1||||0.813|TWO_SIDED|95.0|-0.62|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.62|0.813
91658443|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.5||||0.135|TWO_SIDED|95.0|-1.25|0.17||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.17|-1.25|0.135
91524602|NCT03315936|182924094|OTHER||gMean ratio (T/R) %|110.83|||||TWO_SIDED|90.0|101.2|121.38|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||121.38|101.20|
91658444|NCT02087904|183210257|SUPERIORITY||LS Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.85|0.57||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.85|0.679
91658445|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|0.0||||0.978|TWO_SIDED|95.0|-0.76|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.79|-0.76|0.978
91658446|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|0.0||||0.925|TWO_SIDED|95.0|-0.75|0.82||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.82|-0.75|0.925
91658447|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.2||||0.659|TWO_SIDED|95.0|-0.96|0.61||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.61|-0.96|0.659
91658448|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.2||||0.633|TWO_SIDED|95.0|-1.1|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-1.1|0.633
91524603|NCT03315936|182924095|OTHER||gMean ratio (T/R) %|110.46|||||TWO_SIDED|90.0|89.74|135.96|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 28.6.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||135.96|89.74|
91527708|NCT01976364|182930498|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91527477|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|43.13||||0.0378|TWO_SIDED|95.0|2.44|83.83|||random coefficient regression|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC \[mL\]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status \& gender, fixed continuous effects of time \& bl. FVC (mL), age, height, trt -by time \& bl.-by-time interactions. Random effects included for patient response for both time \& intercept.~Within-patient errors were modelled by an Unstructured variance-covariance matrix."||83.83|2.44|0.0378
91658449|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.3||||0.46|TWO_SIDED|95.0|-1.23|0.56||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.56|-1.23|0.46
91658450|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.7|-1.1|0.663
91712964|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.28|0.75|
91712965|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.61|0.55|
91712966|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.69|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.69|0.23|
91618865|NCT03006471|183130886|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.463
91618866|NCT03006471|183130887|SUPERIORITY|||||||0.53||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.530
91618867|NCT03006471|183130887|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.507
91618868|NCT03006471|183130888|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
91618869|NCT03006471|183130888|SUPERIORITY|||||||0.972||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.972
91618870|NCT03006471|183130889|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
91618871|NCT03006471|183130889|SUPERIORITY|||||||0.158||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.158
91618872|NCT03006471|183130890|SUPERIORITY|||||||0.944||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.944
91618873|NCT03006471|183130890|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.650
91618874|NCT03006471|183130891|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.087
91618875|NCT03006471|183130891|SUPERIORITY|||||||0.345||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.345
91618876|NCT03006471|183130892|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention group||||0.115
91618877|NCT03006471|183130893|SUPERIORITY|||||||0.047||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.047
91618878|NCT03006471|183130894|SUPERIORITY|||||||0.539||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.539
91618879|NCT03006471|183130895|SUPERIORITY|||||||0.844||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.844
91618880|NCT03006471|183130895|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.010
91618881|NCT03006471|183130896|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
91618882|NCT03006471|183130896|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
91618883|NCT03006471|183130897|SUPERIORITY|||||||0.221||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.221
91658451|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.1||||0.696|TWO_SIDED|95.0|-0.89|0.59||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.59|-0.89|0.696
91618884|NCT03006471|183130897|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.001
91618885|NCT03006471|183130898|SUPERIORITY|||||||0.461||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.461
91618886|NCT03006471|183130898|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
91524604|NCT00860067|182924103|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV A/H1N1.|Ratio of geometric mean|1.09|||||TWO_SIDED|95.0|1.01|1.18|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.18|1.01|
91524605|NCT00860067|182924103|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV A/H3N2.|Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.14|0.96|
91524606|NCT00860067|182924103|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: (FluMist B/Yamagata) divided by (Q/LAIV B/Yamagata).|Ratio of geometric mean|1.1|||||TWO_SIDED|95.0|0.97|1.25|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.25|0.97|
91618887|NCT03006471|183130899|SUPERIORITY|||||||0.285||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.285
91524607|NCT00860067|182924103|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: (FluMist B/Victoria) divided by (Q/LAIV B/Victoria).|Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.82|1.03|||Bootstrapping|Confidence intervals were calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.03|0.82|
91524608|NCT00770432|182924149|SUPERIORITY_OR_OTHER|||||||0.0595||95.0|||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).||||||0.0595
91618888|NCT03006471|183130899|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.002
91618889|NCT03006471|183130900|SUPERIORITY|||||||0.701||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.701
91618890|NCT03006471|183130900|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.081
91618891|NCT03006471|183130901|SUPERIORITY|||||||0.581||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.581
91791598|NCT03274999|183460934|SUPERIORITY|||||||0.447||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.447
91791599|NCT03274999|183460934|SUPERIORITY|||||||0.328||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
91791600|NCT03274999|183460934|SUPERIORITY|||||||0.09||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
91791601|NCT03274999|183460934|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
91791602|NCT03274999|183460934|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
91791603|NCT03274999|183460934|SUPERIORITY|||||||0.5||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.500
91791604|NCT01527357|183460941|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
91658452|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.4||||0.278|TWO_SIDED|95.0|-1.16|0.34||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.34|-1.16|0.278
91658453|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.4||||0.357|TWO_SIDED|95.0|-1.1|0.4||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.4|-1.1|0.357
91658454|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.87|0.64||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.64|-0.87|0.761
91791605|NCT01527357|183460942|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
91791606|NCT01527357|183460943|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
91658455|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.5||||0.218|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-1.02|0.218
91658456|NCT02087904|183210258|SUPERIORITY||LS Mean Difference|-0.3||||0.513|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.51|-1.02|0.513
91658457|NCT02087904|183210259|SUPERIORITY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.52|0.75||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.75|-0.52|0.728
91791607|NCT01527357|183460944|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
91791608|NCT02233946|183460949|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.47|1.02||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.02|0.47|
91791609|NCT02233946|183460949|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.57|1.31||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.31|0.57|
91791610|NCT02233946|183460950|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.4|1.1||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.10|0.40|
91618892|NCT03006471|183130901|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group||||0.004
91618893|NCT03006471|183130902|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.727
91618894|NCT03006471|183130902|SUPERIORITY|||||||0.451||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.451
91658458|NCT02087904|183210259|SUPERIORITY||LS Mean Difference|-0.4||||0.219|TWO_SIDED|95.0|-1.06|0.24||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.24|-1.06|0.219
91658459|NCT02087904|183210259|SUPERIORITY||LS Mean Difference|-0.1||||0.673|TWO_SIDED|95.0|-0.79|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-0.79|0.673
91658460|NCT02087904|183210260|SUPERIORITY||LS Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.73|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.71|-0.73|0.984
91658461|NCT02087904|183210260|SUPERIORITY||LS Mean Difference|-0.5||||0.145|TWO_SIDED|95.0|-1.26|0.19||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.19|-1.26|0.145
91791611|NCT02233946|183460951|SUPERIORITY|Participants who reported past-12-month use of alcohol or other drugs at baseline|Cox Proportional Hazard|0.62|||||TWO_SIDED|95.0|0.41|0.94||||||||0.94|0.41|
91791612|NCT02233946|183460951|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.44|1.32||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.32|0.44|
91791613|NCT02233946|183460952|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.5|1.34||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.34|0.50|
91791614|NCT02233946|183460952|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||1.19|0.44|
91618895|NCT03006471|183130903|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.463
91618896|NCT03006471|183130903|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.043
91618897|NCT03006471|183130904|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.807
91618898|NCT03006471|183130904|SUPERIORITY|||||||0.754||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.754
91618899|NCT03006471|183130905|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.507
91791615|NCT02233946|183460952|SUPERIORITY||Risk Ratio (RR)|0.58|||||TWO_SIDED|95.0|0.37|0.91||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||0.91|0.37|
91791616|NCT02233946|183460952|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.43|1.23||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.23|0.43|
91791617|NCT02233946|183460952|SUPERIORITY||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.67|2.66||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||2.66|0.67|
91791618|NCT02233946|183460952|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.5|1.99||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||1.99|0.50|
91791619|NCT02927067|183460970|NON_INFERIORITY|Non-inferiority (NI) margin of primary efficacy endpoint was 7%. If lower limit of 95% confidence interval (CI) was greater than -7%, NI was assumed. Power calculation: Assuming 68% (maribavir), 60% (valganciclovir) participants achieve confirmed viremia clearance,494 participants (247 per group) would yield \>90% power to declare NI based on 2-group test of equivalence in proportions. Considering 10% dropout,550 participants (275 per group) were planned to be enrolled and randomized.|Difference in Percentage of Responders|-7.7|||||TWO_SIDED|95.0|-14.98|-0.36|||||Cochran-Mantel-Haenszel (CMH) weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for adjusted difference in percentage of responders (Maribavir-Valganciclovir), 95% CI, and p-value.|||-0.36|-14.98|
91791620|NCT02927067|183460971|NON_INFERIORITY|The non-inferiority margin of the key secondary efficacy endpoint was 7%. If the lower limit of the 95% CI was greater than -7%, then noninferiority (NI) was assumed. Because the NI of the primary efficacy endpoint was not established, the NI hypothesis of the key secondary endpoint was not tested formally.|Difference in Percentage of Responders|4.4|||||TWO_SIDED|95.0|-3.91|12.76|||||CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|||12.76|-3.91|
91791621|NCT02927067|183460972|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||||16.30|-0.38|=0.061
91658462|NCT02087904|183210260|SUPERIORITY||LS Mean Difference|-0.2||||0.527|TWO_SIDED|95.0|-0.96|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.96|0.527
91618900|NCT03006471|183130905|SUPERIORITY|||||||0.015||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.015
91618901|NCT03006471|183130906|SUPERIORITY|||||||0.039||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.039
91618902|NCT03006471|183130907|SUPERIORITY|||||||0.011|||||||Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.011
91618903|NCT03006471|183130908|SUPERIORITY|||||||0.096||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.096
91618904|NCT02370498|183130951|OTHER||Hazard Ratio (HR)|1.27||||0.98358|TWO_SIDED|95.0|1.03|1.57||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.57|1.03|0.98358
91618905|NCT02370498|183130952|OTHER||Hazard Ratio (HR)|0.82||||0.04205|TWO_SIDED|95.0|0.66|1.03||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.03|0.66|0.04205
91618906|NCT02370498|183130953|OTHER||Hazard Ratio (HR)|1.49||||0.99999|TWO_SIDED|95.0|1.25|1.77||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.77|1.25|0.99999
91618907|NCT02370498|183130954|OTHER||Hazard Ratio (HR)|0.94||||0.24463|TWO_SIDED|95.0|0.79|1.12||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.12|0.79|0.24463
91618908|NCT02370498|183130955|OTHER||Hazard Ratio (HR)|0.98||||0.41331|TWO_SIDED|95.0|0.79|1.21||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.21|0.79|0.41331
91618909|NCT02370498|183130956|OTHER||Hazard Ratio (HR)|1.19||||0.97481|TWO_SIDED|95.0|1.0|1.42||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.42|1.00|0.97481
91618910|NCT02370498|183130957|OTHER||Hazard Ratio (HR)|1.11||||0.80696|TWO_SIDED|95.0|0.89|1.38||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.38|0.89|0.80696
91618911|NCT02370498|183130958|OTHER||Hazard Ratio (HR)|1.34||||0.99932|TWO_SIDED|95.0|1.12|1.6||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.60|1.12|0.99932
91618912|NCT02370498|183130959|OTHER||Hazard Ratio (HR)|1.45||||0.99661|TWO_SIDED|95.0|1.11|1.89||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.89|1.11|0.99661
91618913|NCT02370498|183130960|OTHER||Hazard Ratio (HR)|1.77||||1|TWO_SIDED|95.0|1.42|2.2||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||2.20|1.42|1.00000
91618914|NCT02370498|183130961|OTHER||Hazard Ratio (HR)|0.97||||0.3928|TWO_SIDED|95.0|0.77|1.23||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.23|0.77|0.39280
91618915|NCT02370498|183130962|OTHER||Hazard Ratio (HR)|1.21||||0.97033|TWO_SIDED|95.0|1.0|1.47||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.47|1.00|0.97033
91658463|NCT02087904|183210261|SUPERIORITY||LS Mean Difference|0.1||||0.836|TWO_SIDED|95.0|-0.71|0.87||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.87|-0.71|0.836
91658464|NCT02087904|183210261|SUPERIORITY||LS Mean Difference|-0.1||||0.738|TWO_SIDED|95.0|-0.94|0.66||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.66|-0.94|0.738
91658465|NCT02087904|183210261|SUPERIORITY||LS Mean Difference|-0.4||||0.3|TWO_SIDED|95.0|-1.22|0.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.38|-1.22|0.3
91658466|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|0.5||||0.992|TWO_SIDED|95.0|-101.59|102.62||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||102.62|-101.59|0.992
91618916|NCT02370498|183130963|OTHER||Difference in Percentage|2.0||||0.28967|TWO_SIDED|95.0|-5.0|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.0|0.28967
91618917|NCT02370498|183130964|OTHER||Difference in Percentage|-1.3||||0.6901|TWO_SIDED|95.0|-6.5|4.0||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||4.0|-6.5|0.69010
91618918|NCT02370498|183130965|OTHER||Difference in Percentage|1.6||||0.3322|TWO_SIDED|95.0|-5.8|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months), weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.8|0.33220
91618919|NCT02370498|183130966|OTHER||Difference in Percentage|-3.0||||0.85922|TWO_SIDED|95.0|-8.5|2.6||Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.||2.6|-8.5|0.85922
91618920|NCT02370498|183130972|OTHER||Difference in Percentage|-3.2|||||TWO_SIDED|95.0|-6.9|0.2||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.||0.2|-6.9|
91658467|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|3.6||||0.948|TWO_SIDED|95.0|-103.95|111.1||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||111.10|-103.95|0.948
91618921|NCT02387372|183130979|OTHER||Geometric least squares mean ratio (GMR)|1.38|||||TWO_SIDED|90.0|1.21|1.56|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.56|1.21|
91618922|NCT02387372|183130979|OTHER||GMR|1.15|||||TWO_SIDED|90.0|1.03|1.29|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.29|1.03|
91618923|NCT02387372|183130982|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.5|1.96|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.96|1.50|
91618924|NCT02387372|183130982|OTHER||GMR|1.33|||||TWO_SIDED|90.0|1.14|1.55|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.55|1.14|
91618925|NCT02387372|183130984|OTHER||Geometric least squares mean ratio (GMR)|1.61|||||TWO_SIDED|90.0|1.44|1.81|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.81|1.44|
91618926|NCT02387372|183130984|OTHER||GMR|1.24|||||TWO_SIDED|90.0|1.11|1.39|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.39|1.11|
91618927|NCT02387372|183130985|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.51|1.95|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.95|1.51|
91618928|NCT02387372|183130985|OTHER||GMR|1.2|||||TWO_SIDED|90.0|1.09|1.33|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.33|1.09|
91618929|NCT03546413|183131011|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Regression, Logistic|||Test for equivalence between the groups||||<0.001
91618930|NCT03546413|183131012|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.055|||||||Regression, Logistic|||Test for equivalence between the groups||||0.055
91618931|NCT03546413|183131013|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Wilcoxon (Mann-Whitney)|||||||<0.001
91618932|NCT03546413|183131013|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.|||||<|0.001||||||This is the calculated p-value|Regression, Linear|||||||<0.001
91618933|NCT03546413|183131013|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.939|||||||Regression, Linear|||||||0.939
91618934|NCT03546413|183131013|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.002|||||||Regression, Linear|||||||0.002
91618935|NCT03546413|183131014|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
91618936|NCT03546413|183131014|SUPERIORITY|A linear regression model was used on the log of peanut skin prick test with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.208|||||||Regression, Linear|||||||0.208
91618937|NCT03546413|183131014|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.587|||||||Regression, Linear|||||||0.587
91618938|NCT03546413|183131014|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.268|||||||Regression, Linear|||||||0.268
91618939|NCT03546413|183131015|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
91618940|NCT03546413|183131015|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.371|||||||Regression, Linear|||||||0.371
91618941|NCT03546413|183131015|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.483|||||||Regression, Linear|||||||0.483
91618942|NCT03546413|183131015|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.643|||||||Regression, Linear|||||||0.643
91618943|NCT03546413|183131016|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
91618944|NCT03546413|183131016|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.857|||||||Regression, Linear|||||||0.857
91618945|NCT03546413|183131016|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.87|||||||Regression, Linear|||||||0.870
91618946|NCT03546413|183131017|SUPERIORITY|||||||0.658|||||||Regression, Logistic|||||||0.658
91527709|NCT01976364|182930498|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91618947|NCT03546413|183131017|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.1|||||||Regression, Logistic|||||||0.100
91618948|NCT03546413|183131017|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Linear|||||||0.502
91618949|NCT03546413|183131017|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.397|||||||Regression, Linear|||||||0.397
91618950|NCT03546413|183131018|SUPERIORITY|||||||0.659|||||||Regression, Logistic|||||||0.659
91618951|NCT03546413|183131018|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.26|||||||Regression, Logistic|||||||0.260
91618952|NCT03546413|183131018|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.075|||||||Regression, Linear|||||||0.075
91618953|NCT03546413|183131018|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.192|||||||Regression, Logistic|||||||0.192
91618954|NCT03546413|183131019|SUPERIORITY|||||||0.729|||||||Regression, Logistic|||||||0.729
91618955|NCT03546413|183131019|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.75|||||||Regression, Logistic|||||||0.750
91618956|NCT03546413|183131019|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.155|||||||Regression, Logistic|||||||0.155
91618957|NCT03546413|183131019|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.458|||||||Regression, Logistic|||||||0.458
91618958|NCT03546413|183131020|SUPERIORITY|||||||0.33|||||||Regression, Logistic|||||||0.330
91618959|NCT03546413|183131020|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.351|||||||Regression, Logistic|||||||0.351
91618960|NCT03546413|183131020|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Logistic|||||||0.502
91618961|NCT03546413|183131020|SUPERIORITY|||||||0.732||||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.|Regression, Logistic|||||||0.732
91618962|NCT03546413|183131021|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.202|||||||Regression, Logistic|||||||0.202
91618963|NCT03546413|183131021|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in older siblings.|||
91618964|NCT03546413|183131021|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in parents.|||
91618965|NCT03546413|183131022|SUPERIORITY|||||||0.029|||||||Regression, Logistic|||||||0.029
91618966|NCT03546413|183131022|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.489|||||||Regression, Logistic|||||||0.489
91618967|NCT03546413|183131022|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the model was unable to converge due to the low percentage of peanut-related adverse events in older siblings.|||
91658468|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|-33.1||||0.523|TWO_SIDED|95.0|-134.76|68.65||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||68.65|-134.76|0.523
91524609|NCT01453348|182924152|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV)|Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.6|1.32||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The Analysis of variance (ANCOVA) model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||1.32|0.6|
91618968|NCT02504268|183131023|SUPERIORITY|||||||0.2359|||||||Regression, Logistic|||||||0.2359
91618969|NCT02504268|183131024|SUPERIORITY|||||||0.0112|||||||Regression, Logistic|||||||0.0112
91618970|NCT02504268|183131025|SUPERIORITY|||||||0.0021|||||||Regression, Logistic|||||||0.0021
91618971|NCT02504268|183131026|SUPERIORITY||||||<|0.0001|||||||rank-based ANCOVA|||||||< 0.0001
91618972|NCT02504268|183131027|SUPERIORITY|||||||0.0006|||||||Regression, Logistic|||||||0.0006
91618973|NCT00424294|183131075|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Chi-squared|||||||0.733
91618974|NCT00424294|183131076|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED||||||Chi-squared|||Week 1: p-value was calculated by Chi-square test.||||0.463
91618975|NCT00424294|183131076|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Chi-squared|||Week 2: p-value was calculated by Chi-square test.||||0.549
91618976|NCT00424294|183131076|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Chi-squared|||Week 4: p-value was calculated by Chi-square test.||||0.272
91618977|NCT00424294|183131076|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Chi-squared|||Week 8: p-value was calculated by Chi-square test.||||0.265
91618978|NCT00424294|183131077|SUPERIORITY_OR_OTHER|||||||0.939|TWO_SIDED||||||Fisher Exact|||Week 4: p-value was calculated by Fisher exact test.||||0.939
91618979|NCT00424294|183131077|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Week 8: p-value was calculated by Fisher exact test.||||0.323
91618980|NCT00424294|183131077|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.338
91618981|NCT00424294|183131078|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.746
91618982|NCT00424294|183131079|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||ANCOVA|||Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.635
91618983|NCT00424294|183131079|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.044
91618984|NCT00424294|183131079|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.957
91618985|NCT00424294|183131079|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.597
91618986|NCT00424294|183131079|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.960
91618987|NCT00424294|183131080|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.252
91618988|NCT00424294|183131080|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.032
91618989|NCT00424294|183131080|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.031
91524610|NCT01453348|182924152|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg)|Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.59|2.37||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||2.37|0.59|
91618990|NCT00424294|183131080|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.018
91712967|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.02|||||TWO_SIDED|95.0|0.53|1.95|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.95|0.53|
91618991|NCT00424294|183131080|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.170
91618992|NCT00424294|183131081|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.507
91524611|NCT01498822|182924173|NON_INFERIORITY_OR_EQUIVALENCE|The primary analysis of this study aimed to demonstrate that LEV was noninferior to OXC with respect to the treatment failure rate in the Per Protocol Set. The noninferiority margin was 15 %.|Absolut difference|-10.7|||||TWO_SIDED|95.0|-20.2|-1.2|||Wald methodology||"Absolute difference in treatment failure rates of LEV versus OXC is defined as Treatment Failure Rate LEV minus Treatment Failure Rate OXC."|||-1.2|-20.2|
91524612|NCT03592277|182924177|SUPERIORITY|||||||0.344|||||||Chi-squared|||||||0.344
91712968|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|3.0|||||TWO_SIDED|95.0|1.57|5.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.74|1.57|
91524613|NCT03592277|182924178|SUPERIORITY|||||||0.526|||||||Chi-squared|||||||0.526
91524614|NCT03592277|182924179|SUPERIORITY|||||||0.123|||||||Chi-squared|||||||0.123
91791622|NCT02927067|183460973|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||16.30|-0.38|=0.061
91524615|NCT03592277|182924180|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.660
91524616|NCT03592277|182924181|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
91791623|NCT02927067|183460973|SUPERIORITY||Difference in Percentage of Responders|13.4|||=|0.001|TWO_SIDED|95.0|5.23|21.62||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||21.62|5.23|=0.001
91524617|NCT03592277|182924182|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
91524618|NCT02917265|182924200|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91524619|NCT02481375|182924205|OTHER||Marginal means|0.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Marginal means (95% CI) of ferritin concentrations at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters||||<0.05
91658469|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|4.2||||0.799|TWO_SIDED|95.0|-28.47|36.95||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||36.95|-28.47|0.799
91618993|NCT00424294|183131081|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.743
91791624|NCT02927067|183460973|SUPERIORITY||Difference in Percentage of Responders|13.8|||<|0.001|TWO_SIDED|95.0|5.8|21.87||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 16||21.87|5.80|<0.001
91524620|NCT05436912|182924216|OTHER||Geometric Mean Ratio|168.9||||0.3601|TWO_SIDED|90.0|61.3|465.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||465.3|61.3|0.3601
91618994|NCT00424294|183131081|SUPERIORITY_OR_OTHER|||||||0.914|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.914
91524621|NCT05436912|182924216|OTHER||Geometric Mean Ratio|92.2||||0.9146|TWO_SIDED|90.0|23.0|368.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||368.9|23.0|0.9146
91658470|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|9.0||||0.609|TWO_SIDED|95.0|-25.62|43.64||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||43.64|-25.62|0.609
91618995|NCT00424294|183131081|SUPERIORITY_OR_OTHER|||||||0.715|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.715
91618996|NCT00424294|183131081|SUPERIORITY_OR_OTHER|||||||0.558|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.558
91618997|NCT00424294|183131082|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.172
91618998|NCT00424294|183131082|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.738
91618999|NCT00424294|183131082|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
91619000|NCT00424294|183131082|SUPERIORITY_OR_OTHER|||||||0.428|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.428
91619001|NCT00424294|183131082|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.861
91619002|NCT00424294|183131083|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.325
91658471|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|1.6||||0.923|TWO_SIDED|95.0|-30.97|34.19||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||34.19|-30.97|0.923
91619003|NCT00424294|183131083|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.386
91619004|NCT00424294|183131083|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.532
91619005|NCT00424294|183131083|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.909
91619006|NCT00424294|183131083|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.994
91619007|NCT00424294|183131084|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.369
91619008|NCT00424294|183131084|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.666
91619009|NCT00424294|183131084|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.530
91619010|NCT00424294|183131084|SUPERIORITY_OR_OTHER|||||||0.632|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.632
91619011|NCT00424294|183131084|SUPERIORITY_OR_OTHER|||||||0.801|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.801
91619012|NCT00424294|183131085|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.052
91658472|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|2.1||||0.937|TWO_SIDED|95.0|-49.88|54.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||54.08|-49.88|0.937
91658473|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|4.1||||0.882|TWO_SIDED|95.0|-50.68|58.95||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||58.95|-50.68|0.882
91524622|NCT05436912|182924216|OTHER||Geometric Mean Ratio|119.6||||0.7478|TWO_SIDED|90.0|43.4|329.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||329.3|43.4|0.7478
91524623|NCT05436912|182924218|OTHER||Geometric Mean Ratio|126.1||||0.4279|TWO_SIDED|90.0|74.8|212.8|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.8|74.8|0.4279
91619013|NCT00424294|183131085|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.108
91658474|NCT02087904|183210262|SUPERIORITY||LS Mean Difference|13.8||||0.602|TWO_SIDED|95.0|-38.05|65.55||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||65.55|-38.05|0.602
91619014|NCT00424294|183131085|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.573
91619015|NCT00424294|183131085|SUPERIORITY_OR_OTHER|||||||0.342|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.342
91619016|NCT00424294|183131085|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.501
91619017|NCT00424294|183131086|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.701
91619018|NCT00424294|183131086|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.167
91619019|NCT00424294|183131086|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
91619020|NCT00424294|183131086|SUPERIORITY_OR_OTHER|||||||0.834|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.834
91619021|NCT00424294|183131086|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.977
91619022|NCT00424294|183131087|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.291
91619023|NCT00424294|183131087|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.080
91619024|NCT00424294|183131087|SUPERIORITY_OR_OTHER|||||||0.466|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.466
91619025|NCT00424294|183131087|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.267
91619026|NCT00424294|183131087|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.100
91619027|NCT01496430|183131097|SUPERIORITY_OR_OTHER|||||||0.007||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.007
91619028|NCT01496430|183131097|SUPERIORITY_OR_OTHER|||||||0.067||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.067
91619029|NCT01496430|183131098|SUPERIORITY_OR_OTHER|||||||0.86||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.860
91619030|NCT01496430|183131098|SUPERIORITY_OR_OTHER|||||||0.21||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.210
91619031|NCT01100307|183131120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.0003|TWO_SIDED|95.0|1.92|12.28||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|Cochran-Mantel-Haenszel|Stratification factors (HbA1c and baseline visual acuity categories)||The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||12.28|1.92|0.0003
91658475|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|-41.7||||0.554|TWO_SIDED|95.0|-180.49|97.04||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||97.04|-180.49|0.554
91658476|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|2.7||||0.97|TWO_SIDED|95.0|-140.86|146.31||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||146.31|-140.86|0.97
91658477|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|-26.1||||0.713|TWO_SIDED|95.0|-165.47|113.32||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||113.32|-165.47|0.713
91619032|NCT01100307|183131121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.0006|TWO_SIDED|95.0|1.1|3.94||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||3.94|1.10|0.0006
91619033|NCT01100307|183131121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.0001|TWO_SIDED|95.0|1.81|5.58||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||5.58|1.81|0.0001
91619034|NCT01100307|183131121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.0096|TWO_SIDED|95.0|0.65|4.65||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||4.65|0.65|0.0096
91658478|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|-25.1||||0.272|TWO_SIDED|95.0|-70.12|19.88||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||19.88|-70.12|0.272
91619035|NCT01100307|183131121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.0001|TWO_SIDED|95.0|2.19|6.32||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||6.32|2.19|<0.0001
91619036|NCT01962714|183131166|NON_INFERIORITY|The primary outcome of non-inferiority of LKM relative to CPT-C was assessed using a non-inferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD symptoms based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a large sample (N=198) of treatment-seeking veterans.|Mean Difference (Final Values)|2.09|||||TWO_SIDED|95.0|-2.59|6.78|||||Non-inferiority of LKM to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||6.78|-2.59|
91619037|NCT01962714|183131167|NON_INFERIORITY|For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen's d effect size of approximately 0.50.|Mean Difference (Final Values)|2.34|||||TWO_SIDED|95.0|-0.52|5.2|||||Non-inferiority of LKM with respect to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||5.20|-0.52|
91619038|NCT01151579|183131168|NON_INFERIORITY_OR_EQUIVALENCE|A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.01|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.||||0.01
91619039|NCT01151579|183131169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.05|TWO_SIDED|95.0||||Analysis adjusted with Fischer exact chi-square for rare occurrences.|Chi-squared|||Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.||||0.05
91619040|NCT01151579|183131170|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||descriptive|Descriptive statistics (frequency) used to report the number of participants experiencing an event.||To report on the number of events.||||0
91619041|NCT00608530|183131171|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Repeated measures analysis of variance compared differences between and within groups (CBT and Supportive Care) from baseline to end of treatment. Statistical testing was performed using 2-tailed tests and alpha level of .05 for declaring statistical significance. The trial was powered at the \>.80 level to detect differences between condition based on projected sample N = 130; given the N = 66 actually achieved our a priori power for detecting differences between groups was .63.||||.05
91619042|NCT00608530|183131172|SUPERIORITY|||||||0.05|||||||ANOVA|||Primary analyses consisted of modified intent-to-treat analysis of all randomized participants who attended at least 1 treatment session, with multiple imputation to address missing data. The study was powered at 80% to detect large effect sizes (\>.50SD) and alpha of .05 with a recruitment goal N = 140; with the N = 61 actually obtained, our a priori power was .55 to detect between group differences.||||.05
91619043|NCT00608530|183131173|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance comparing groups at baseline and end of treatment.||||>0.05
91619044|NCT00608530|183131175|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||.05
91619045|NCT00077610|183131177|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.004|STANDARD_ERROR_OF_MEAN|0.0973|<|0.0001|TWO_SIDED|97.5|-0.215|0.223|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.||0.223|-0.215|<0.0001
91619046|NCT00077610|183131177|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.051|STANDARD_ERROR_OF_MEAN|0.0997|<|0.0001|TWO_SIDED|97.5|-0.173|0.275|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.||0.275|-0.173|<0.0001
91658479|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|11.1||||0.64|TWO_SIDED|95.0|-35.63|57.8||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||57.8|-35.63|0.64
91658480|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|-11.8||||0.608|TWO_SIDED|95.0|-56.94|33.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||33.38|-56.94|0.608
91658481|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|-40.3||||0.319|TWO_SIDED|95.0|-119.88|39.3||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||39.3|-119.88|0.319
91658482|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|24.4||||0.56|TWO_SIDED|95.0|-58.05|106.91||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||106.91|-58.05|0.56
91658483|NCT02087904|183210263|SUPERIORITY||LS Mean Difference|-28.1||||0.489|TWO_SIDED|95.0|-107.97|51.82||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||51.82|-107.97|0.489
91712969|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|5.28|||||TWO_SIDED|95.0|2.83|9.87|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.87|2.83|
91712970|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.39|5.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.07|1.39|
91712971|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.76|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.34|0.76|
91712972|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|1.12|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.46|1.12|
91712973|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.72|2.15|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.15|0.72|
91619047|NCT00305253|183131190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.019|TWO_SIDED|95.0|0.17|0.85|||Regression, Logistic|Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).|Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|"Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used."||0.85|0.17|0.019
91658484|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|0.0||||0.972|TWO_SIDED|95.0|-0.015|0.015||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.015|0.972
91658485|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|-0.001||||0.929|TWO_SIDED|95.0|-0.017|0.015||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.017|0.929
91658486|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|-0.005||||0.543|TWO_SIDED|95.0|-0.02|0.01||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.01|-0.02|0.543
91658487|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|0.008||||0.752|TWO_SIDED|95.0|-0.043|0.059||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.059|-0.043|0.752
91658488|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|0.011||||0.691|TWO_SIDED|95.0|-0.042|0.064||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.042|0.691
91658489|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|0.01||||0.71|TWO_SIDED|95.0|-0.041|0.06||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.06|-0.041|0.71
91658490|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|0.0||||0.965|TWO_SIDED|95.0|-0.019|0.02||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.02|-0.019|0.965
91658491|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|-0.002||||0.885|TWO_SIDED|95.0|-0.022|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.019|-0.022|0.885
91658492|NCT02087904|183210264|SUPERIORITY||LS Mean Difference|0.001||||0.887|TWO_SIDED|95.0|-0.018|0.021||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.021|-0.018|0.887
91658493|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.005||||0.619|TWO_SIDED|95.0|-0.024|0.014||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.014|-0.024|0.619
91524624|NCT05436912|182924218|OTHER||Geometric Mean Ratio|92.4||||0.8341|TWO_SIDED|90.0|46.4|183.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.9|46.4|0.8341
91658494|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.001||||0.952|TWO_SIDED|95.0|-0.02|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.019|-0.02|0.952
91658495|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.003||||0.765|TWO_SIDED|95.0|-0.022|0.016||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.016|-0.022|0.765
91658496|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.04||||0.258|TWO_SIDED|95.0|-0.11|0.03||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.03|-0.11|0.258
91658497|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|0.023||||0.535|TWO_SIDED|95.0|-0.049|0.094||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.094|-0.049|0.535
91658498|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.006||||0.866|TWO_SIDED|95.0|-0.076|0.064||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.076|0.866
91658499|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.012||||0.413|TWO_SIDED|95.0|-0.041|0.017||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.017|-0.041|0.413
91658500|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|0.012||||0.445|TWO_SIDED|95.0|-0.018|0.042||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.042|-0.018|0.445
91658501|NCT02087904|183210265|SUPERIORITY||LS Mean Difference|-0.003||||0.835|TWO_SIDED|95.0|-0.032|0.026||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.026|-0.032|0.835
91658502|NCT02087904|183210266|SUPERIORITY||Response Rate Difference|7.0||||0.311|TWO_SIDED|95.0|-7.3|21.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||21.4|-7.3|0.311
91658503|NCT02087904|183210266|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
91658504|NCT02087904|183210266|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
91712974|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.34|||||TWO_SIDED|95.0|0.76|2.36|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.36|0.76|
91712975|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.64|1.65|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.65|0.64|
91712976|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.39|||||TWO_SIDED|95.0|0.87|2.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.24|0.87|
91619048|NCT00305253|183131191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.79|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Mean measured volume of blood loss in the drape was compared across phases with t-tests.||||<0.0001
91619049|NCT00305253|183131192|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.05|TWO_SIDED|95.0|0.21|0.8|||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Relative risks and confidence intervals were computed for emergency hysterectomy.||0.80|0.21|<0.05
91619050|NCT01098461|183131203|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.57|||t-test, 2 sided|||||-0.57|-1.22|<0.0001
91619051|NCT01098461|183131203|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.55|||<|0.0001|TWO_SIDED|95.0|-1.88|-1.23|||t-test, 2 sided|||||-1.23|-1.88|<0.0001
91619052|NCT01098461|183131203|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.78|||t-test, 2 sided|||||-0.78|-1.43|<0.0001
91619053|NCT02662985|183131212|SUPERIORITY||Median Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.52|-0.85|||Mixed Models Analysis|mixed model repeated measures (MMRM)||GLOESS scores||-0.85|-5.52|0.0040
91619054|NCT02662985|183131213|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.38|8.89|||Regression, Logistic|Logistic regression using non-responder imputation||Proportion of patients with ACR 20 response at Week 12 (FAS)||8.89|2.38|<0.0001
91619055|NCT02662985|183131214|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.0001|TWO_SIDED|95.0|3.92|23.75|||Regression, Logistic|||Proportion of patients with ACR 50 response at Week 12 (FAS)||23.75|3.92|<0.0001
91619056|NCT02662985|183131215|SUPERIORITY||Adjusted mean of treatment difference|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0327|TWO_SIDED|95.0|-1.374|0.043|||Regression, Logistic|||SPARCC||0.043|-1.374|0.0327
91619057|NCT01153763|183131216|OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|48.2|70.3|||||The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.|||70.3|48.2|
91619058|NCT01153763|183131217|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|0.0|28.7|||||The estimated value represents the percentage of participants with a investigator assessed CR or PR.|||28.7|0.0|
91619059|NCT01153763|183131222|OTHER||percentage of participants|20.0|||||TWO_SIDED|95.0|11.6|29.8|||||The estimated value represents the percentage of participants with overall survival.|||29.8|11.6|
91619060|NCT01153763|183131223|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|2.2|34.6|||||The estimated value represents the percentage of participants with overall survival.|||34.6|2.2|
91524625|NCT05436912|182924218|OTHER||Geometric Mean Ratio|169.1||||0.1159|TWO_SIDED|90.0|97.1|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.1|0.1159
91619061|NCT01486784|183131230|OTHER||||||||||||||||||Based on the dose limiting toxicities occurring in each dosing cohort, a maximum tolerated dose (MTD) may be determined by assessing the highest dosing level presenting no dose limiting toxicities. An MTD of 17mg/m2 twice weekly was established.|||
91619062|NCT03491553|183131384|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619063|NCT03491553|183131384|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619064|NCT03491553|183131384|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619065|NCT03491553|183131384|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
91619066|NCT03491553|183131385|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619067|NCT03491553|183131385|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619068|NCT03491553|183131385|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91712977|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.68|1.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.71|0.68|
91712978|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|0.73|||||TWO_SIDED|95.0|0.45|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.45|
91619069|NCT03491553|183131385|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619070|NCT03491553|183131386|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619071|NCT03491553|183131386|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619072|NCT03491553|183131386|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619073|NCT03491553|183131386|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619074|NCT03491553|183131387|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619075|NCT03491553|183131387|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619076|NCT03491553|183131387|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619077|NCT03491553|183131387|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619078|NCT03491553|183131388|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91658505|NCT02087904|183210267|SUPERIORITY||Response Rate Difference|2.4||||0.744|TWO_SIDED|95.0|-11.9|16.8||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||16.8|-11.9|0.744
91658506|NCT02087904|183210267|SUPERIORITY||Response Rate Difference|4.3||||0.581|TWO_SIDED|95.0|-10.1|18.7||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||18.7|-10.1|0.581
91619079|NCT03491553|183131388|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619080|NCT03491553|183131388|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
91619081|NCT03491553|183131388|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
91619082|NCT01606761|183131443|SUPERIORITY_OR_OTHER||Percentage Difference|15.9|||<|0.001|TWO_SIDED|95.0|8.5|23.2|||Cochran-Mantel-Haenszel|||||23.2|8.5|< 0.001
91619083|NCT01606761|183131443|SUPERIORITY_OR_OTHER||Percentage Difference|21.0|||<|0.001|TWO_SIDED|95.0|13.6|28.5|||Cochran-Mantel-Haenszel|||||28.5|13.6|< 0.001
91619084|NCT01606761|183131444|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.251|-0.088|||ANCOVA|||||-0.088|-0.251|< 0.001
91619085|NCT01606761|183131444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.194|||<|0.001|TWO_SIDED|95.0|-0.275|-0.112|||ANCOVA|||||-0.112|-0.275|< 0.001
91619086|NCT01606761|183131445|SUPERIORITY_OR_OTHER||Percentage Difference|12.0|||<|0.001|TWO_SIDED|95.0|6.4|17.7|||Cochran-Mantel-Haenszel|||||17.7|6.4|< 0.001
91619087|NCT01606761|183131445|SUPERIORITY_OR_OTHER||Percentage Difference|12.7|||<|0.001|TWO_SIDED|95.0|7.0|18.4|||Cochran-Mantel-Haenszel|||||18.4|7.0|< 0.001
91619088|NCT01606761|183131446|SUPERIORITY_OR_OTHER||Percentage Difference|11.0|||<|0.001|TWO_SIDED|95.0|5.5|16.5|||Cochran-Mantel-Haenszel|||||16.5|5.5|< 0.001
91619089|NCT01606761|183131446|SUPERIORITY_OR_OTHER||Percentage Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.8|19.1|||Cochran-Mantel-Haenszel|||||19.1|7.8|< 0.001
91619090|NCT04237207|183131447|NON_INFERIORITY|The primary efficacy objective is to demonstrate non-inferiority of AutoSense on the M90 processor compared to AutoSound on the Q90 processor for the AzBio sentence test in quiet mode based on a paired t-test. The primary efficacy analyses will test the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quiet mode (AutoSense on M90 - AutoSound on Q90) are less than or equal to -10 percentage points.||||||0.001|||||||t-test, 2 sided|||||||0.0010
91619091|NCT04237207|183131448|NON_INFERIORITY|The 1st secondary endpoint was to demonstrate that speech recognition in noise with AutoSense on a 301-M062 processor was no worse than speech recognition in noise with currently approved software on a Q90 processor.||||||0.001|||||||t-test, 2 sided|||||||0.0010
91619092|NCT04237207|183131449|NON_INFERIORITY|"The 2nd secondary endpoint was to demonstrate increased speech recognition in noise with the 301-M062 sound processor when comparing Omnidirectional program to AutoSense."|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91619093|NCT06704178|183131454|SUPERIORITY|||||||0.488445|||||||Multiple t-tests|||||||0.488445
91619094|NCT06704178|183131455|SUPERIORITY|Between-group comparison.||||||0.98317||||||Between-group comparison.|t-test, 2 sided|||||||0.98317
91619095|NCT06704178|183131456|SUPERIORITY|||||||0.98317|||||||t-test, 2 sided|||||||0.98317
91619096|NCT06704178|183131457|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
91619097|NCT06704178|183131458|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
91619098|NCT06704178|183131459|SUPERIORITY|||||||0.954882||||||Comparison at Month 2|t-test, 2 sided|||||||0.954882
91658507|NCT02087904|183210267|SUPERIORITY||Response Rate Difference|10.4||||0.146|TWO_SIDED|95.0|-3.5|24.3||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||24.3|-3.5|0.146
91658508|NCT02087904|183210268|SUPERIORITY||Response Rate Difference|-1.3||||0.824|TWO_SIDED|95.0|-14.9|12.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||12.4|-14.9|0.824
91658509|NCT02087904|183210268|SUPERIORITY||Response Rate Difference|0.8||||0.964|TWO_SIDED|95.0|-12.8|14.5||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||14.5|-12.8|0.964
91658510|NCT02087904|183210268|SUPERIORITY||Response Rate Difference|2.1||||0.763|TWO_SIDED|95.0|-11.3|15.6||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||15.6|-11.3|0.763
91658511|NCT00891293|183210280|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.3|STANDARD_DEVIATION|29.01||0.9999||95.0|-2.8|9.4|||ANOVA||Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment|For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.||9.4|-2.8|0.9999
91658512|NCT01973348|183210303|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 12 subjects per group has been shown to be effective for estimating within-group means and variances when little prior data is available.(Julius, 2005) Based on collected data from 34 subjects and effective size difference of 0.1, we reestimate this study as a noninferiority trial with continuous outcome and power calculated as approximately 80%.||||||0.88|||||||t-test, 1 sided|||||||0.88
91658513|NCT00669864|183210408|SUPERIORITY_OR_OTHER||Estimated mean|-1.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-1.414|-1.192||A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.|t-test, 1 sided|||The null hypothesis (H0): HbA1c after 16 weeks - HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks - HbA1c at baseline \< 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease||-1.192|-1.414|<0.0001
91658514|NCT01941030|183210420|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.022|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty reduction of calcium out of lumen gain.||||0.0220
91658515|NCT01941030|183210421|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6228|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-balloon angioplasty minimum lumen area stenosis.||||0.6228
91658516|NCT01941030|183210422|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.4528|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty plaque area.||||0.4528
91658517|NCT01941030|183210423|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.3573|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty dense calcium area.||||0.3573
91619099|NCT06704178|183131459|SUPERIORITY|||||||0.246176||||||Comparison at Month 4|t-test, 2 sided|||||||0.246176
91619100|NCT06704178|183131459|SUPERIORITY|||||||0.954882||||||Comparison at Month 6|t-test, 2 sided|||||||0.954882
91619101|NCT06704178|183131460|SUPERIORITY|||||||0.483382||||||Comparison at Month 2|t-test, 2 sided|||||||0.483382
91619102|NCT06704178|183131460|SUPERIORITY|||||||0.483382||||||Comparison at Month 4|t-test, 2 sided|||||||0.483382
91619103|NCT06704178|183131460|SUPERIORITY|||||||0.726742||||||Comparison at Month 6|t-test, 2 sided|||||||0.726742
91619104|NCT06704178|183131461|SUPERIORITY|||||||0.999216||||||Comparison at Month 1|t-test, 2 sided|||||||0.999216
91658518|NCT01941030|183210424|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6073|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty necrotic core area.||||0.6073
91619105|NCT06704178|183131461|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619106|NCT06704178|183131461|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
91619107|NCT06704178|183131461|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
91619108|NCT06704178|183131461|SUPERIORITY|||||||0.952545||||||Comparison at Month 5|t-test, 2 sided|||||||0.952545
91712979|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.53|2.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.52|0.53|
91712980|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.8|||||TWO_SIDED|95.0|0.9|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.62|0.90|
91712981|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.65|||||TWO_SIDED|95.0|0.84|3.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.23|0.84|
91712982|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.17|||||TWO_SIDED|95.0|0.58|2.35|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.35|0.58|
91712983|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.71|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.97|0.71|
91524626|NCT05436912|182924219|OTHER||Geometric Mean Ratio|126.0||||0.4289|TWO_SIDED|90.0|74.8|212.4|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.4|74.8|0.4289
91524627|NCT05436912|182924219|OTHER||Geometric Mean Ratio|92.3||||0.8322|TWO_SIDED|90.0|46.5|183.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.3|46.5|0.8322
91712984|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.89|3.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||3.19|0.89|
91712985|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.63|2.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.14|0.63|
91619109|NCT06704178|183131461|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
91619110|NCT06704178|183131462|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
91619111|NCT06704178|183131462|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619112|NCT06704178|183131462|SUPERIORITY|||||||0.999801|||||||t-test, 2 sided|||||||0.999801
91619113|NCT06704178|183131462|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
91619114|NCT06704178|183131462|SUPERIORITY|||||||0.993223||||||Comparison at Month 5|t-test, 2 sided|||||||0.993223
91619115|NCT06704178|183131462|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
91619116|NCT06704178|183131463|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
91619117|NCT06704178|183131463|SUPERIORITY|||||||0.999838||||||Comparison at Month 2|t-test, 2 sided|||||||0.999838
91619118|NCT06704178|183131463|SUPERIORITY|||||||0.991697||||||Comparison at Month 3|t-test, 2 sided|||||||0.991697
91619119|NCT06704178|183131463|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
91619120|NCT06704178|183131463|SUPERIORITY|||||||0.581904||||||Comparison at Month 5|t-test, 2 sided|||||||0.581904
91619121|NCT06704178|183131463|SUPERIORITY|||||||0.999866||||||Comparison at Month 6|t-test, 2 sided|||||||0.999866
91619122|NCT06704178|183131464|SUPERIORITY|||||||0.999835||||||Comparison at Month 1|t-test, 2 sided|||||||0.999835
91712986|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|0.83|||||TWO_SIDED|95.0|0.44|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.57|0.44|
91619123|NCT06704178|183131464|SUPERIORITY|||||||0.962016||||||Comparison at Month 2|t-test, 2 sided|||||||0.962016
91619124|NCT06704178|183131464|SUPERIORITY|||||||0.995044||||||Comparison at Month 3|t-test, 2 sided|||||||0.995044
91619125|NCT06704178|183131464|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
91619126|NCT06704178|183131464|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
91619127|NCT06704178|183131464|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
91619128|NCT06704178|183131465|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
91619129|NCT06704178|183131465|SUPERIORITY|||||||0.999524||||||Comparison at Month 2|t-test, 2 sided|||||||0.999524
91619130|NCT06704178|183131465|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
91619131|NCT06704178|183131465|SUPERIORITY|||||||0.772865||||||Comparison at Month 4|t-test, 2 sided|||||||0.772865
91619132|NCT06704178|183131465|SUPERIORITY|||||||0.91384||||||Comparison at Month 5|t-test, 2 sided|||||||0.91384
91619133|NCT06704178|183131465|SUPERIORITY|||||||0.992841||||||Comparison at Month 6|t-test, 2 sided|||||||0.992841
91619134|NCT06704178|183131466|SUPERIORITY|||||||0.999732||||||Comparison at Month 1|t-test, 2 sided|||||||0.999732
91619135|NCT06704178|183131466|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619136|NCT06704178|183131466|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
91619137|NCT06704178|183131466|SUPERIORITY||||||>|0.999999||||||Comparison at Month 4|t-test, 2 sided|||||||>0.999999
91619138|NCT06704178|183131466|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
91712987|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.56|2.91|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.91|0.56|
91712988|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.21|5.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.81|1.21|
91524628|NCT05436912|182924219|OTHER||Geometric Mean Ratio|169.6||||0.1131|TWO_SIDED|90.0|97.6|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.6|0.1131
91619139|NCT06704178|183131466|SUPERIORITY||||||>|0.999999||||||Comparison at Month 6|t-test, 2 sided|||||||>0.999999
91619140|NCT06704178|183131467|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
91619141|NCT06704178|183131467|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619142|NCT06704178|183131467|SUPERIORITY|||||||0.998326||||||Comparison at Month 3|t-test, 2 sided|||||||0.998326
91619143|NCT06704178|183131467|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
91619144|NCT06704178|183131467|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
91619145|NCT06704178|183131467|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
91619146|NCT06704178|183131468|SUPERIORITY|||||||0.999387||||||Comparison at Month 1|t-test, 2 sided|||||||0.999387
91619147|NCT06704178|183131468|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619148|NCT06704178|183131468|SUPERIORITY||||||>|0.999999||||||Comparison at Month 3|t-test, 2 sided|||||||>0.999999
91619149|NCT06704178|183131468|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
91619150|NCT06704178|183131468|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
91619151|NCT06704178|183131468|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
91619152|NCT06704178|183131469|SUPERIORITY|||||||0.999975||||||Comparison at Month 1|t-test, 2 sided|||||||0.999975
91619153|NCT06704178|183131469|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619154|NCT06704178|183131469|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
91619155|NCT06704178|183131469|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
91619156|NCT06704178|183131469|SUPERIORITY|||||||0.960874||||||Comparison at Month 5|t-test, 2 sided|||||||0.960874
91619157|NCT06704178|183131469|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
91619158|NCT06704178|183131470|SUPERIORITY|||||||0.981906||||||Comparison at Month 1|t-test, 2 sided|||||||0.981906
91619159|NCT06704178|183131470|SUPERIORITY|||||||0.945027||||||Comparison at Month 2|t-test, 2 sided|||||||0.945027
91619160|NCT06704178|183131470|SUPERIORITY|||||||0.767795||||||Comparison at Month 3|t-test, 2 sided|||||||0.767795
91712989|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.7|3.18|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.18|0.70|
91712990|NCT03311841|183317587|OTHER||Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.43|2.08|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.08|0.43|
91712991|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.48|0.63|
91712992|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.69|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.62|0.69|
91524629|NCT02413463|182924256|SUPERIORITY|Chi-square test||||||0.18||||||This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group|Chi-squared|||An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted||||0.18
91712993|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.62|1.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.41|0.62|
91791625|NCT02927067|183460973|SUPERIORITY||Difference in Percentage of Responders|9.7|||=|0.014|TWO_SIDED|95.0|1.98|17.5||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||17.50|1.98|=0.014
91712994|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|95.0|0.36|0.83|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.83|0.36|
91524630|NCT02413463|182924257|SUPERIORITY|||||||0.22||||||This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)|t-test, 2 sided|||||||0.22
91619161|NCT06704178|183131470|SUPERIORITY|||||||0.996139||||||Comparison at Month 4|t-test, 2 sided|||||||0.996139
91619162|NCT06704178|183131470|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
91619163|NCT06704178|183131470|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
91619164|NCT06704178|183131471|SUPERIORITY|||||||0.55783||||||Comparison at Month 1|t-test, 2 sided|||||||0.55783
91619165|NCT06704178|183131471|SUPERIORITY|||||||0.987949||||||Comparison at Month 2|t-test, 2 sided|||||||0.987949
91619166|NCT06704178|183131471|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
91619167|NCT06704178|183131471|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
91619168|NCT06704178|183131471|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
91619169|NCT06704178|183131471|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
91619170|NCT06704178|183131472|SUPERIORITY|||||||0.795476||||||Comparison at Month 1|t-test, 2 sided|||||||0.795476
91619171|NCT06704178|183131472|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
91658519|NCT01941030|183210425|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.2149|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrous plaque area.||||0.2149
91658520|NCT01941030|183210426|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.0579|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrofatty plaque area.||||0.0579
91712995|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.84|||||TWO_SIDED|95.0|0.44|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.61|0.44|
91658521|NCT01941030|183210427|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.076|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 600 mcg adenosine.||||0.076
91658522|NCT01941030|183210427|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.205|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 1200 mcg adenosine.||||0.205
91712996|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.71|||||TWO_SIDED|95.0|0.89|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.89|
91712997|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.93|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.93|
91712998|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.72|||||TWO_SIDED|95.0|0.38|1.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.38|0.38|
91712999|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.92|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.92|
91619172|NCT06704178|183131472|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
91619173|NCT06704178|183131472|SUPERIORITY|||||||0.997753||||||Comparison at Month 4|t-test, 2 sided|||||||0.997753
91619174|NCT06704178|183131472|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
91619175|NCT06704178|183131472|SUPERIORITY|||||||0.988108||||||Comparison at Month 6|t-test, 2 sided|||||||0.988108
91619176|NCT06704178|183131473|SUPERIORITY|||||||0.995367||||||Comparison at Month 1|t-test, 2 sided|||||||0.995367
91619177|NCT06704178|183131473|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
91619178|NCT06704178|183131473|SUPERIORITY|||||||0.974102||||||Comparison at Month 3|t-test, 2 sided|||||||0.974102
91619179|NCT06704178|183131473|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
91619180|NCT06704178|183131473|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
91619181|NCT06704178|183131473|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
91619182|NCT06704178|183131474|SUPERIORITY|||||||0.882016||||||Comparison at Month 1|t-test, 2 sided|||||||0.882016
91619183|NCT06704178|183131474|SUPERIORITY|||||||0.860406||||||Comparison at Month 2|t-test, 2 sided|||||||0.860406
91619184|NCT06704178|183131474|SUPERIORITY|||||||0.958944||||||Comparison at Month 3|t-test, 2 sided|||||||0.958944
91619185|NCT06704178|183131474|SUPERIORITY|||||||0.998816||||||Comparison at Month 4|t-test, 2 sided|||||||0.998816
91619186|NCT06704178|183131474|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
91619187|NCT06704178|183131474|SUPERIORITY|||||||0.999296||||||Comparison at Month 6|t-test, 2 sided|||||||0.999296
91619188|NCT06704178|183131475|SUPERIORITY|||||||0.999975||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999975
91619189|NCT06704178|183131475|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
91619190|NCT06704178|183131475|SUPERIORITY|||||||0.999||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999
91619191|NCT06704178|183131475|SUPERIORITY|||||||0.999984||||||Comparison at Month 4.|t-test, 2 sided|||||||0.999984
91619192|NCT06704178|183131475|SUPERIORITY|||||||0.986557||||||Comparison at Month 5.|t-test, 2 sided|||||||0.986557
91619193|NCT06704178|183131475|SUPERIORITY|||||||0.998367||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998367
91619194|NCT06704178|183131476|SUPERIORITY|||||||0.999851||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999851
91619195|NCT06704178|183131476|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
91619196|NCT06704178|183131476|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
91619197|NCT06704178|183131476|SUPERIORITY|||||||0.998467||||||Comparison at Month 4.|t-test, 2 sided|||||||0.998467
91619198|NCT06704178|183131476|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
91619199|NCT06704178|183131476|SUPERIORITY|||||||0.998846||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998846
91619200|NCT06704178|183131477|SUPERIORITY||||||>|0.999999||||||Comparison at Month 1.|t-test, 2 sided|||||||>0.999999
91619201|NCT06704178|183131477|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
91619202|NCT06704178|183131477|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
91658523|NCT04448678|183210431|OTHER|||||||0.0401|||||||t-test, 2 sided|||||||0.0401
91658524|NCT04448678|183210432|OTHER|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
91658525|NCT04448678|183210433|OTHER|||||||0.297|||||||t-test, 2 sided|||||||0.297
91658526|NCT04166032|183210444|OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.210
91713000|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.14|2.98|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.98|1.14|
91713001|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.84|2.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.11|0.84|
91713002|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.47|||||TWO_SIDED|95.0|0.91|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.38|0.91|
91713003|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.19|||||TWO_SIDED|95.0|0.81|1.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.75|0.81|
91713004|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.2|||||TWO_SIDED|95.0|0.82|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.76|0.82|
91658527|NCT02781727|183210445|NON_INFERIORITY|Non-inferiority comparison with a non-inferiority margin of 2 cm/year, followed by a test of superiority if non-inferiority is established.||||||0.0088||||||P-value is based on a test of superiority|ANCOVA with multiple imputation|two-sided||ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable; treatment and gender as factors; and baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.||||0.0088
91658528|NCT00113425|183210451|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
91713005|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.75|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.57|0.75|
91713006|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.89|||||TWO_SIDED|95.0|0.61|1.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.31|0.61|
91658529|NCT00113425|183210452|SUPERIORITY_OR_OTHER|||||||0.43|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.43
91658530|NCT00113425|183210453|SUPERIORITY_OR_OTHER|||||||0.79|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.79
91658531|NCT00113425|183210454|SUPERIORITY_OR_OTHER|||||||0.1|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.10
91658532|NCT00113425|183210455|SUPERIORITY_OR_OTHER|||||||0.73|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.73
91658533|NCT00113425|183210456|SUPERIORITY_OR_OTHER|||||||0.02|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.02
91658534|NCT00113425|183210457|SUPERIORITY_OR_OTHER|||||||0.003|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.003
91658535|NCT00113425|183210458|SUPERIORITY_OR_OTHER|||||||0.62|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.62
91658536|NCT00113425|183210459|SUPERIORITY_OR_OTHER|||||||0.85|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.85
91658537|NCT00113425|183210460|SUPERIORITY_OR_OTHER|||||||0.49|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.49
91713007|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.48|||||TWO_SIDED|95.0|0.58|3.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.75|0.58|
91713008|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|2.54|||||TWO_SIDED|95.0|1.11|5.85|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||5.85|1.11|
91713009|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|2.16|||||TWO_SIDED|95.0|0.97|4.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||4.81|0.97|
91658538|NCT00113425|183210461|SUPERIORITY_OR_OTHER|||||||0.21|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.21
91658539|NCT00113425|183210462|SUPERIORITY_OR_OTHER|||||||0.27|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.27
91658540|NCT00113425|183210463|SUPERIORITY_OR_OTHER|||||||0.04|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.04
91658541|NCT00113425|183210464|SUPERIORITY_OR_OTHER|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
91658542|NCT01569152|183210492|SUPERIORITY_OR_OTHER||Difference of percentages|43.9|||<|0.001|TWO_SIDED|95.0|24.52|63.28|||Cochran-Mantel-Haenszel|||||63.28|24.52|<0.001
91658543|NCT01569152|183210493|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.53|-0.43|||Constrained Longitudinal Data Analysis|||||-0.43|-1.53|<0.001
91658544|NCT01569152|183210494|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.11|||<|0.001|TWO_SIDED|95.0|-1.62|-0.6|||Constrained Longitudinal Data Analysis|||||-0.60|-1.62|<0.001
91619203|NCT06704178|183131477|SUPERIORITY|||||||0.963236||||||Comparison at Month 4.|t-test, 2 sided|||||||0.963236
91619204|NCT06704178|183131477|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
91619205|NCT06704178|183131477|SUPERIORITY|||||||0.737995||||||Comparison at Month 6.|t-test, 2 sided|||||||0.737995
91619206|NCT06704178|183131478|SUPERIORITY|||||||0.0003||||||Within-group analysis only.|t-test, 2 sided|||||||0.0003
91619207|NCT06704178|183131479|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
91619208|NCT06704178|183131480|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
91619209|NCT06704178|183131481|SUPERIORITY|||||||0.2137||||||Within-group analysis only.|t-test, 2 sided|||||||0.2137
91619210|NCT06704178|183131482|SUPERIORITY|||||||0.8639||||||Within-group analysis only.|t-test, 2 sided|||||||0.8639
91619211|NCT06704178|183131483|SUPERIORITY|||||||0.239||||||Within-group analysis only.|t-test, 2 sided|||||||0.239
91619212|NCT06704178|183131484|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
91619213|NCT06704178|183131485|SUPERIORITY|||||||0.5738||||||Within-group analysis only.|t-test, 2 sided|||||||0.5738
91619214|NCT06704178|183131486|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
91658545|NCT01569152|183210495|SUPERIORITY_OR_OTHER||Difference in percentages|14.63||||0.044|TWO_SIDED|95.0|0.83|28.44|||Cochran-Mantel-Haenszel|||||28.44|0.83|0.044
91658546|NCT01569152|183210498|SUPERIORITY_OR_OTHER||Difference in percentages|31.71||||0.004|TWO_SIDED|95.0|11.29|52.13|||Cochran-Mantel-Haenszel|||||52.13|11.29|0.004
91658547|NCT01569152|183210499|SUPERIORITY_OR_OTHER||Difference in percentages|29.27||||0.007|TWO_SIDED|95.0|8.9|49.63|||Cochran-Mantel-Haenszel|||||49.63|8.90|0.007
91658548|NCT01569152|183210500|SUPERIORITY_OR_OTHER||Difference in percentages|9.76||||0.039|TWO_SIDED|95.0|0.67|18.84|||Cochran-Mantel-Haenszel|||||18.84|0.67|0.039
91658549|NCT01569152|183210501|SUPERIORITY_OR_OTHER||Difference in percentages|12.2||||0.018|TWO_SIDED|95.0|2.18|22.21|||Cochran-Mantel-Haenszel|||||22.21|2.18|0.018
91658550|NCT01569152|183210504|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.75||||0.028|TWO_SIDED|95.0|-8.99|-0.52|||Constrained Longitudinal Data Analysis|||||-0.52|-8.99|0.028
91658551|NCT01569152|183210505|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.11|TWO_SIDED|95.0|-5.91|0.62|||Constrained Longitudinal Data Analysis|||||0.62|-5.91|0.110
91658552|NCT01569152|183210506|SUPERIORITY_OR_OTHER||Difference in least squares means|-10.56||||0.002|TWO_SIDED|95.0|-16.97|-4.15|||Constrained Longitudinal Data Analysis|||||-4.15|-16.97|0.002
91658553|NCT01569152|183210509|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.84|||<|0.001|TWO_SIDED|95.0|-29.98|-11.71|||Constrained Longitudinal Data Analysis|||||-11.71|-29.98|<0.001
91658554|NCT01569152|183210510|SUPERIORITY_OR_OTHER||Difference in least squares means|-19.48|||<|0.001|TWO_SIDED|95.0|-29.69|-9.28|||Constrained Longitudinal Data Analysis|||||-9.28|-29.69|<0.001
91658555|NCT01569152|183210511|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.69|||<|0.001|TWO_SIDED|95.0|-31.29|-10.09|||Constrained Longitudinal Data Analysis|||||-10.09|-31.29|<0.001
91658556|NCT01569152|183210512|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.84|-0.4|||Constrained Longitudinal Data Analysis|||||-0.40|-0.84|< 0.001
91658557|NCT01569152|183210513|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.59||||0.007|TWO_SIDED|95.0|-2.73|-0.45|||Constrained Longitudinal Data Analysis|||||-0.45|-2.73|0.007
91658558|NCT01569152|183210514|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.9||||0.315|TWO_SIDED|95.0|-14.54|4.74|||Constrained Longitudinal Data Analysis|||||4.74|-14.54|0.315
91658559|NCT01569152|183210516|SUPERIORITY_OR_OTHER||Difference in percentages|31.71|||<|0.001|TWO_SIDED|95.0|15.56|47.86|||Cochran-Mantel-Haenszel|||||47.86|15.56|<0.001
91658560|NCT01523899|183210520|SUPERIORITY||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0||||Pearson chi squared, Fisher exact, 2 sample t-tests||||||||
91658561|NCT01523899|183210521|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
91658562|NCT00743197|183210526|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|0|Other|0.0|STANDARD_DEVIATION|0.0||||||||0||||0||||
91658563|NCT00963482|183210557|SUPERIORITY_OR_OTHER||||||=|0.111||95.0||||not adjusted for multiple comparisons due to only two groups p\<.05, two-tailed|Chi-squared|||"H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CG"||||=.111
91658564|NCT02653664|183210559|SUPERIORITY|||||||0.39||||||Statistical significance was set at p=.05|ANOVA|||Based on our prior work comparing similar interventions, assuming decreases in average pain intensity of 0.3 points (on a 0-10 scale) for ED, between 0.8 to 1.4 points for HYP, and between 0.6 to 1 for MM, with standard deviations (SD) ranging from 0.15 to 1, significance level of 0.05, and using ANOVA as the statistical method, we calculated that 80 participants per arm at immediate post-treatment would provide at least 80% power to detect between-groups differences as specified.||||.39
91658565|NCT02653664|183210560|SUPERIORITY|||||||0.05||||||Statistical significance was set at p=.05.|ANOVA|||||||.05
91658566|NCT02653664|183210561|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p= .05|ANOVA|||||||<.001
91658567|NCT00485472|183210563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.36||||0.5438||95.0|-5.3|10.02|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||10.02|-5.30|0.5438
91658568|NCT00485472|183210564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.83||||0.2022||95.0|-2.62|12.28|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||12.28|-2.62|0.2022
91658569|NCT00485472|183210565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79||||0.665||95.0|-6.36|9.93|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||9.93|-6.36|0.6650
91658570|NCT00485472|183210566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.74||||0.3445||95.0|-11.65|33.13|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||33.13|-11.65|0.3445
91658571|NCT00485472|183210568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0418||95.0|0.245|0.974|||Likelihood ratio test|||Analysis of 'response' based on a likelihood ratio test with treatment and pooled site as factors.||0.974|0.245|0.0418
91658572|NCT02055963|183210576|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||||||0.98
91658573|NCT03247556|183210597|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0082|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Model for Repeated Measures|||||-1.3|-8.9|0.0082
91658574|NCT03247556|183210597|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.93||0.0712|TWO_SIDED|95.0|-7.3|0.3|||Mixed Model for Repeated Measures|||||0.3|-7.3|0.0712
91658575|NCT03247556|183210598|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0051|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0051
91658576|NCT03247556|183210598|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0995|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||0.1|-0.6|0.0995
91713010|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|2.94|||||TWO_SIDED|95.0|1.28|6.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||6.77|1.28|
91791626|NCT02927067|183460974|SUPERIORITY||Difference in Percentage of Responders|-7.3|||=|0.051|TWO_SIDED|95.0|-14.64|0.02||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||0.02|-14.64|=0.051
91791627|NCT02927067|183460974|SUPERIORITY||Difference in Percentage of Responders|2.2|||=|0.606|TWO_SIDED|95.0|-6.05|10.37||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||10.37|-6.05|=0.606
91658577|NCT03247556|183210599|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.26||0.1377|TWO_SIDED|95.0|-4.3|0.6|||ANCOVA|||||0.6|-4.3|0.1377
91524631|NCT02413463|182924258|SUPERIORITY|||||||0.02||||||This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)|t-test, 2 sided|||||||0.02
91658578|NCT03247556|183210599|SUPERIORITY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.25||0.313|TWO_SIDED|95.0|-3.7|1.2|||ANCOVA|||||1.2|-3.7|0.3130
91658579|NCT03247556|183210600|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.049||0.0698|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.0698
91658580|NCT03247556|183210600|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9756|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.10|-0.10|0.9756
91658581|NCT03247556|183210601|SUPERIORITY||Risk Difference (RD)|15.3||||0.0349|TWO_SIDED|95.0|1.3|29.3|||Regression, Logistic|||||29.3|1.3|0.0349
91658582|NCT03247556|183210601|SUPERIORITY||Risk Difference (RD)|13.1||||0.0698|TWO_SIDED|95.0|-0.9|27.0|||Regression, Logistic|||||27.0|-0.9|0.0698
91658583|NCT03247556|183210602|SUPERIORITY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|4.76||0.1259|TWO_SIDED|95.0|-16.6|2.0|||ANCOVA|||||2.0|-16.6|0.1259
91658584|NCT03247556|183210602|SUPERIORITY||Least Square Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|4.78||0.7417|TWO_SIDED|95.0|-7.8|10.9|||ANCOVA|||||10.9|-7.8|0.7417
91658585|NCT03247556|183210603|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.97||0.0484|TWO_SIDED|95.0|-3.8|0.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.0|-3.8|0.0484
91658586|NCT03247556|183210603|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.96||0.2084|TWO_SIDED|95.0|-3.1|0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||0.7|-3.1|0.2084
91658587|NCT03247556|183210603|SUPERIORITY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0042|TWO_SIDED|95.0|-5.1|-1.0|||ANCOVA|||This analysis pertains to the Inattention subscale score||-1.0|-5.1|0.0042
91658588|NCT03247556|183210603|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1392|TWO_SIDED|95.0|-3.6|0.5|||ANCOVA|||This analysis pertains to the Inattention subscale score||0.5|-3.6|0.1392
91658589|NCT03247556|183210604|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.381|TWO_SIDED|95.0|-3.0|1.2|||ANCOVA|||||1.2|-3.0|0.3810
91658590|NCT03247556|183210604|SUPERIORITY||Least Square Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.08||0.0432|TWO_SIDED|95.0|-4.3|-0.1|||ANCOVA|||||-0.1|-4.3|0.0432
91713011|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.59|2.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.07|0.59|
91713012|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.24|||||TWO_SIDED|95.0|0.71|2.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.17|0.71|
91713013|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.62|0.55|
91713014|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.96|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.96|0.64|
91524632|NCT02413463|182924259|SUPERIORITY|||||||0.03||||||This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||0.03
91619215|NCT06704178|183131487|SUPERIORITY|||||||0.4942||||||Within-group analysis only.|t-test, 2 sided|||||||0.4942
91619216|NCT06704178|183131488|SUPERIORITY|||||||0.7419||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7419
91619217|NCT06704178|183131488|SUPERIORITY|||||||0.0033||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0033
91619218|NCT06704178|183131488|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
91619219|NCT06704178|183131489|SUPERIORITY|||||||0.7708||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7708
91619220|NCT06704178|183131489|SUPERIORITY|||||||0.239||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.239
91619221|NCT06704178|183131489|SUPERIORITY|||||||0.006||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.006
91619222|NCT06704178|183131490|SUPERIORITY|||||||0.0219||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
91619223|NCT06704178|183131490|SUPERIORITY|||||||0.0001||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0001
91619224|NCT06704178|183131490|SUPERIORITY||||||<|0.0001||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||<0.0001
91619225|NCT06704178|183131491|SUPERIORITY|||||||0.0695||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0695
91619226|NCT06704178|183131491|SUPERIORITY|||||||0.0124||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0124
91619227|NCT06704178|183131491|SUPERIORITY|||||||0.0016||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0016
91619228|NCT06704178|183131492|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619229|NCT06704178|183131492|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619230|NCT06704178|183131492|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619231|NCT06704178|183131492|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619232|NCT06704178|183131492|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619233|NCT06704178|183131492|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619234|NCT06704178|183131493|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619235|NCT06704178|183131493|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619236|NCT06704178|183131493|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619237|NCT06704178|183131493|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619238|NCT06704178|183131493|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619239|NCT06704178|183131493|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619240|NCT06704178|183131494|SUPERIORITY|||||||0.4598||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4598
91619241|NCT06704178|183131494|SUPERIORITY|||||||0.23||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.23
91619242|NCT06704178|183131494|SUPERIORITY|||||||0.0806||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0806
91619243|NCT06704178|183131494|SUPERIORITY|||||||0.0969||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0969
91619244|NCT06704178|183131494|SUPERIORITY|||||||0.6098||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
91619245|NCT06704178|183131494|SUPERIORITY|||||||0.0369||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0369
91619246|NCT06704178|183131495|SUPERIORITY|||||||0.0384||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0384
91619247|NCT06704178|183131495|SUPERIORITY|||||||0.6328||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6328
91619248|NCT06704178|183131495|SUPERIORITY|||||||0.0026||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0026
91619249|NCT06704178|183131495|SUPERIORITY|||||||0.0012||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0012
91619250|NCT06704178|183131495|SUPERIORITY|||||||0.0118||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0118
91619251|NCT06704178|183131495|SUPERIORITY|||||||0.0221||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0221
91619252|NCT06704178|183131496|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619253|NCT06704178|183131496|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91713015|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.1|||||TWO_SIDED|95.0|0.46|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.64|0.46|
91713016|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.87|||||TWO_SIDED|95.0|0.81|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.32|0.81|
91619254|NCT06704178|183131496|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619255|NCT06704178|183131496|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619256|NCT06704178|183131496|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619257|NCT06704178|183131496|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619258|NCT06704178|183131497|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619259|NCT06704178|183131497|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91713017|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.51|2.53|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.53|0.51|
91524633|NCT02413463|182924260|SUPERIORITY||||||<|0.01||||||This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||<0.01
91619260|NCT06704178|183131497|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619261|NCT06704178|183131497|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91524634|NCT04203537|182924265|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
91619262|NCT06704178|183131497|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619263|NCT06704178|183131497|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619264|NCT06704178|183131498|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619265|NCT06704178|183131498|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619266|NCT06704178|183131498|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619267|NCT06704178|183131498|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619268|NCT06704178|183131498|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619269|NCT06704178|183131498|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619270|NCT06704178|183131499|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619271|NCT06704178|183131499|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619272|NCT06704178|183131499|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619273|NCT06704178|183131499|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619274|NCT06704178|183131499|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619275|NCT06704178|183131499|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619276|NCT06704178|183131500|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619277|NCT06704178|183131500|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619278|NCT06704178|183131500|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619279|NCT06704178|183131500|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619280|NCT06704178|183131500|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619281|NCT06704178|183131500|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619282|NCT06704178|183131501|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619283|NCT06704178|183131501|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619284|NCT06704178|183131501|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658591|NCT03247556|183210605|SUPERIORITY|||||||0.1433|||||||Chi-squared|||This analysis pertains to Week 1||||0.1433
91658592|NCT03247556|183210605|SUPERIORITY|||||||0.0114|||||||Chi-squared|||This analysis pertains to Week 2||||0.0114
91658593|NCT03247556|183210605|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 3||||0.0008
91658594|NCT03247556|183210605|SUPERIORITY|||||||0.0197|||||||Chi-squared|||This analysis pertains to Week 4||||0.0197
91658595|NCT03247556|183210605|SUPERIORITY|||||||0.0573|||||||Chi-squared|||This analysis pertains to Week 5||||0.0573
91658596|NCT03247556|183210605|SUPERIORITY|||||||0.0105|||||||Chi-squared|||This analysis pertains to Week 6||||0.0105
91658597|NCT03247556|183210605|SUPERIORITY|||||||0.0004|||||||Chi-squared|||This analysis pertains to Week 7||||0.0004
91658598|NCT03247556|183210605|SUPERIORITY|||||||0.2573|||||||Chi-squared|||This analysis pertains to Week 1||||0.2573
91658599|NCT03247556|183210605|SUPERIORITY|||||||0.165|||||||Chi-squared|||This analysis pertains to Week 2||||0.1650
91524635|NCT04203537|182924266|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91658600|NCT03247556|183210605|SUPERIORITY|||||||0.0372|||||||Chi-squared|||This analysis pertains to Week 3||||0.0372
91658601|NCT03247556|183210605|SUPERIORITY|||||||0.1711|||||||Chi-squared|||This analysis pertains to Week 4||||0.1711
91658602|NCT03247556|183210605|SUPERIORITY|||||||0.1428|||||||Chi-squared|||This analysis pertains to Week 5||||0.1428
91658603|NCT03247556|183210605|SUPERIORITY|||||||0.2148|||||||Chi-squared|||This analysis pertains to Week 6||||0.2148
91658604|NCT03247556|183210605|SUPERIORITY|||||||0.0662|||||||Chi-squared|||This analysis pertains to Week 7||||0.0662
91658605|NCT01710657|183210610|SUPERIORITY_OR_OTHER||% Reduction over Placebo|39.6|||<|0.001|TWO_SIDED|95.0|30.5|47.6||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||47.6|30.5|<0.001
91658606|NCT01710657|183210610|SUPERIORITY_OR_OTHER||% Reduction over Placebo|29.4|||<|0.001|TWO_SIDED|95.0|18.7|38.7||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||38.7|18.7|< 0.001
91658607|NCT01297348|183210648|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.01|||||TWO_SIDED|95.0|1.23|3.29||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95 percent (%) confidence interval (CI) was reported for current users.||3.29|1.23|
91658608|NCT01297348|183210648|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.99|||||TWO_SIDED|95.0|0.39|22.8||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95% CI was reported for past users.||22.80|0.39|
91658609|NCT01297348|183210648|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.49|||||TWO_SIDED|95.0|2.02|6.02||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for current users.||6.02|2.02|
91658610|NCT01297348|183210648|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.07|||||TWO_SIDED|95.0|0.34|27.47||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for past users.||27.47|0.34|
91658611|NCT01297348|183210649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.85|2.67||||||Current user, case and matched control: Odds ratio (Lybrel/EE-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||2.67|0.85|
91524636|NCT04203537|182924266|SUPERIORITY|||||||0.0026|||||||ANOVA|||||||0.0026
91658612|NCT01297348|183210649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.98|6.54||||||Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||6.54|0.98|
91658613|NCT02495857|183210650|SUPERIORITY||Mean Difference (Net)|36.18|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
91658614|NCT02495857|183210651|SUPERIORITY||Mean Difference (Net)|36.19|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
91658615|NCT02495857|183210652|EQUIVALENCE|From baseline to week 26 visit, change in the WOMAC stiffness score was evaluated.|Mean Difference (Net)|5.63|||||TWO_SIDED|95.0|-13.61|8.49||||||||8.49|-13.61|
91658616|NCT02058498|183210675|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91658617|NCT04605094|183210677|OTHER||Difference in response rate|-8.62||||0.08|TWO_SIDED|95.0|-17.94|0.71|||Regression, Logistic|||"Treatment difference in IGA responders~Estimates were from a logistic regression model that included treatment group, age as recorded on electronic case report form (eCRF) at screening (\>=12 to \<18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/microliters \[μL\]; \>=300 cells/μL) and baseline value of IGA score."||0.71|-17.94|0.080
91658618|NCT04605094|183210678|OTHER||Difference in response rate|-5.15||||0.384|TWO_SIDED|95.0|-16.67|6.36|||Regression, Logistic|||"Treatment difference in EASI-75 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||6.36|-16.67|0.384
91658619|NCT04605094|183210679|OTHER||Difference in response rate|-8.18||||0.078|TWO_SIDED|95.0|-16.94|0.59|||Regression, Logistic|||"Treatment difference in EASI-90 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||0.59|-16.94|0.078
91658620|NCT04605094|183210680|OTHER||Difference in response rate|0.69||||0.889|TWO_SIDED|95.0|-8.93|10.32|||Regression, Logistic|||"Treatment difference in Peak Pruritus NRS~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline Peak Pruritus score."||10.32|-8.93|0.889
91658621|NCT02724462|183210681|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic|||||1.83|1.22|<.001
91658622|NCT02724462|183210682|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Regression, Logistic|||||1.71|1.14|.001
91658623|NCT02589808|183210698|OTHER|||||||0.0005|||||||Kappa|||||||0.0005
91713018|NCT03311841|183317588|OTHER||Geometric least squares mean ratio|1.04|||||TWO_SIDED|95.0|0.45|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.41|0.45|
91713019|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.78|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||3.62|0.78|
91713020|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.23|0.75|
91619285|NCT06704178|183131501|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619286|NCT06704178|183131501|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619287|NCT06704178|183131501|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658624|NCT01969747|183210726|SUPERIORITY_OR_OTHER||Adjusted mean|76.09|STANDARD_ERROR_OF_MEAN|8.77|<|0.0001|TWO_SIDED|95.0|58.6|93.59|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 2.5 mg with Placebo||93.59|58.60|<0.0001
91658625|NCT01969747|183210726|SUPERIORITY_OR_OTHER||Adjusted mean|106.39|STANDARD_ERROR_OF_MEAN|8.85|<|0.0001|TWO_SIDED|95.0|88.73|124.05|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 10 mg with Placebo||124.05|88.73|<0.0001
91658626|NCT01969747|183210726|SUPERIORITY_OR_OTHER||Adjusted mean|104.81|STANDARD_ERROR_OF_MEAN|8.99|<|0.0001|TWO_SIDED|95.0|86.88|122.74|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 25 mg with Placebo||122.74|86.88|<0.0001
91658627|NCT04000815|183210727|OTHER||||||<|0.017||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||<0.017
91658628|NCT04000815|183210728|OTHER||||||<|0.05|||||||Bi-variate correlation analysis|Bi-variate correlation analyses were performed in groups 1 and 2 between serum CNP and FSH and between serum CNP and LH using Spearman test.||||||<0.05
91658629|NCT04000815|183210729|OTHER||||||<|0.05|||||||Bi-variate correlation|Spearman test was applied.||||||<0.05
91658630|NCT04000815|183210730|OTHER||||||<|0.05|||||||Bi-variate correlation analyses|Bi-variate correlation analyses were performed for all subjects in groups 1 and 2 between serum CNP and E2 using Spearman test.||||||<0.05
91658631|NCT00377260|183210773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.||||< .001
91658632|NCT00377260|183210774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.||||< .001
91658633|NCT00377260|183210775|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||.02
91658634|NCT00377260|183210776|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.||||.24
91619288|NCT06704178|183131502|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619289|NCT06704178|183131502|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619290|NCT06704178|183131502|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619291|NCT06704178|183131502|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619292|NCT06704178|183131502|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619293|NCT06704178|183131502|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619294|NCT06704178|183131503|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619295|NCT06704178|183131503|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619296|NCT06704178|183131503|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619297|NCT06704178|183131503|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658635|NCT00377260|183210777|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.|Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.||||.35
91791628|NCT02927067|183460974|SUPERIORITY||Difference in Percentage of Responders|1.0|||=|0.809|TWO_SIDED|95.0|-7.27|9.31||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||9.31|-7.27|=0.809
91524637|NCT03635489|182924277|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53|||Regression, Cox|||||0.53|0.17|<.0001
91619298|NCT06704178|183131503|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91524638|NCT03635489|182924277|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.58|||Regression, Cox|||||0.58|0.20|<.0001
91524639|NCT03635489|182924278|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.3|1.21||||||||1.21|0.30|
91524640|NCT00361439|182924299|SUPERIORITY_OR_OTHER||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.02
91524641|NCT00361439|182924300|SUPERIORITY_OR_OTHER||||||<|0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.023
91524642|NCT00361439|182924301|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||||||<0.002
91619299|NCT06704178|183131503|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619300|NCT06704178|183131504|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619301|NCT06704178|183131504|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619302|NCT06704178|183131504|SUPERIORITY|||||||0.3682||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3682
91619303|NCT06704178|183131504|SUPERIORITY|||||||0.6098||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
91619304|NCT06704178|183131504|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619305|NCT06704178|183131504|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619306|NCT06704178|183131505|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619307|NCT06704178|183131505|SUPERIORITY|||||||0.5691||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5691
91619308|NCT06704178|183131505|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619309|NCT06704178|183131505|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91791629|NCT02057042|183461067|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91619310|NCT06704178|183131505|SUPERIORITY|||||||0.6983||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
91619311|NCT06704178|183131505|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619312|NCT06704178|183131506|SUPERIORITY|||||||0.819||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
91619313|NCT06704178|183131506|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619314|NCT06704178|183131506|SUPERIORITY|||||||0.5749||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5749
91619315|NCT06704178|183131506|SUPERIORITY|||||||0.4873||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4873
91619316|NCT06704178|183131506|SUPERIORITY|||||||0.9998||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9998
91619317|NCT06704178|183131506|SUPERIORITY|||||||0.819||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
91619318|NCT06704178|183131507|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91791630|NCT02057042|183461068|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91791631|NCT02057042|183461069|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91791632|NCT02057042|183461070|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91791633|NCT02057042|183461071|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91791634|NCT02057042|183461072|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91791635|NCT00920907|183461073|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.01|||||TWO_SIDED|90.0|0.916|1.114|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for Cmax were contained within 80% to 125%.||1.114|0.916|
91791636|NCT00920907|183461077|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.032|||||TWO_SIDED|90.0|0.922|1.156|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for ipilimumab Cmax were contained within 80% to 125%. Point estimates and 90% CIs were constructed for the ratio of geometric means (Process C/Process B) for ipilimumab Cmax.||1.156|0.922|
91791637|NCT00920907|183461082|SUPERIORITY_OR_OTHER||omnibus conditional F-test|0.4||||0.85||||||Not corrected for multiple testing|F-test|numerator 5 degrees freedom, denominator 782 degrees freedom||Time-by-process interaction. Null hypothesis that the pattern of mean ALC values over time is the same for both processes.||||0.85
91791638|NCT00920907|183461082|SUPERIORITY_OR_OTHER||F-statistic|4.35|||<|0.0001|||||||F-test|numerator 10 degrees freedom, denominator 782 degrees freedom||Overall time effect. Null hypothesis of no mean ALC changes over time in either process group (treatment arm).||||<0.0001
91619319|NCT06704178|183131507|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619320|NCT06704178|183131507|SUPERIORITY|||||||0.8495||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8495
91619321|NCT06704178|183131507|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||>0.9999
91619322|NCT06704178|183131507|SUPERIORITY|||||||0.1951||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1951
91619323|NCT06704178|183131507|SUPERIORITY|||||||0.0806||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.0806
91619324|NCT06704178|183131508|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619325|NCT06704178|183131508|SUPERIORITY|||||||0.6983||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
91619326|NCT06704178|183131508|SUPERIORITY|||||||0.1062||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1062
91619327|NCT06704178|183131508|SUPERIORITY|||||||0.0333||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0333
91619328|NCT06704178|183131508|SUPERIORITY|||||||0.0734||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0734
91619329|NCT06704178|183131508|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
91619330|NCT06704178|183131509|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619331|NCT06704178|183131509|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619332|NCT06704178|183131509|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619333|NCT06704178|183131509|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619334|NCT06704178|183131509|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619335|NCT06704178|183131509|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619336|NCT06704178|183131510|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619337|NCT06704178|183131510|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619338|NCT06704178|183131510|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619339|NCT06704178|183131510|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619340|NCT06704178|183131510|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619341|NCT06704178|183131510|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619342|NCT06704178|183131511|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619343|NCT06704178|183131511|SUPERIORITY|||||||0.982||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
91619344|NCT06704178|183131511|SUPERIORITY|||||||0.091||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.091
91619345|NCT06704178|183131511|SUPERIORITY|||||||0.4449||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
91619346|NCT06704178|183131511|SUPERIORITY|||||||0.0204||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0204
91619347|NCT06704178|183131511|SUPERIORITY|||||||0.0256||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0256
91619348|NCT06704178|183131512|SUPERIORITY|||||||0.9821||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9821
91619349|NCT06704178|183131512|SUPERIORITY|||||||0.0403||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0403
91619350|NCT06704178|183131512|SUPERIORITY|||||||0.0638||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0638
91658636|NCT00377260|183210778|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.||||.04
91658637|NCT00377260|183210778|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.||||<.01
91658638|NCT00377260|183210778|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.||||.07
91619351|NCT06704178|183131512|SUPERIORITY|||||||0.7195||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7195
91619352|NCT06704178|183131512|SUPERIORITY|||||||0.1856||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1856
91619353|NCT06704178|183131512|SUPERIORITY|||||||0.1222||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1222
91619354|NCT06704178|183131513|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619355|NCT06704178|183131513|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619356|NCT06704178|183131513|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within group analysis only.||||||>0.9999
91619357|NCT06704178|183131513|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619358|NCT06704178|183131513|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619359|NCT06704178|183131513|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619360|NCT06704178|183131514|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619361|NCT06704178|183131514|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619362|NCT06704178|183131514|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619363|NCT06704178|183131514|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619364|NCT06704178|183131514|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619365|NCT06704178|183131514|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619366|NCT06704178|183131515|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619367|NCT06704178|183131515|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619368|NCT06704178|183131515|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619369|NCT06704178|183131515|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619370|NCT06704178|183131515|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619371|NCT06704178|183131515|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619372|NCT06704178|183131516|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619373|NCT06704178|183131516|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619374|NCT06704178|183131516|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619375|NCT06704178|183131516|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619376|NCT06704178|183131516|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619377|NCT06704178|183131516|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619378|NCT06704178|183131517|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619379|NCT06704178|183131517|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619380|NCT06704178|183131517|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619381|NCT06704178|183131517|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619382|NCT06704178|183131517|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619383|NCT06704178|183131517|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658639|NCT00377260|183210778|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.||||>.99
91658640|NCT00377260|183210778|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.||||>.99
91619384|NCT06704178|183131518|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619385|NCT06704178|183131518|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619386|NCT06704178|183131518|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619387|NCT06704178|183131518|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619388|NCT06704178|183131518|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619389|NCT06704178|183131518|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619390|NCT06704178|183131519|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619391|NCT06704178|183131519|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619392|NCT06704178|183131519|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619393|NCT06704178|183131519|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619394|NCT06704178|183131519|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619395|NCT06704178|183131519|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619396|NCT06704178|183131520|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619397|NCT06704178|183131520|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619398|NCT06704178|183131520|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619399|NCT06704178|183131520|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619400|NCT06704178|183131520|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619401|NCT06704178|183131520|SUPERIORITY|||||||0.982||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
91619402|NCT06704178|183131521|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658641|NCT00377260|183210778|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.||||.99
91658642|NCT00377260|183210778|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.||||.08
91658643|NCT00377260|183210779|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.002
91658644|NCT00377260|183210779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||<.001
91658645|NCT00377260|183210779|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.85
91658646|NCT00377260|183210779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||<.001
91658647|NCT00377260|183210779|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.28
91658648|NCT00377260|183210780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||< .001
91658649|NCT00377260|183210781|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.10
91658650|NCT00377260|183210781|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||.03
91658651|NCT00377260|183210781|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.96
91658652|NCT00377260|183210781|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||.79
91658653|NCT00377260|183210781|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.98
91658654|NCT00377260|183210782|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||.04
91658655|NCT00377260|183210783|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.||||.03
91658656|NCT00377260|183210784|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.||||.006
91658657|NCT00377260|183210785|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||||.04
91658658|NCT00377260|183210786|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.||||.20
91658659|NCT00377260|183210787|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to emergency room||||.90
91658660|NCT00377260|183210788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.14||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1.||||.14
91658661|NCT00377260|183210789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.04||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1 on two consecutive occasions.||||.04
91658662|NCT00377260|183210790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Generalized estimating equations|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.||||<.001
91713021|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.98|||||TWO_SIDED|95.0|1.15|3.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.41|1.15|
91713022|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|0.98|||||TWO_SIDED|95.0|0.58|1.66|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||1.66|0.58|
91524643|NCT00361439|182924302|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.010
91713023|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.52|2.03|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.03|0.52|
91713024|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.51|||||TWO_SIDED|95.0|0.77|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.97|0.77|
91713025|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.07|||||TWO_SIDED|95.0|0.56|2.05|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.05|0.56|
91524644|NCT01313286|182924313|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.08|||||TWO_SIDED|90.0|1.0|1.16|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.16|1.00|
91658663|NCT00377260|183210791|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.||||.93
91658664|NCT00377260|183210792|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.||||.66
91658665|NCT00377260|183210793|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.||||.71
91658666|NCT00377260|183210794|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.||||.04
91658667|NCT00377260|183210795|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.||||.005
91791639|NCT02616601|183461090|EQUIVALENCE|If the 90% confidence interval on the percentage difference between generic fluorouracil cream and Carac (fluorouracil) cream lesion clearance were contained within the interval -0.20 to +0.20, and each of these percentages was greater than and statistically different (p\<0.05) from the vehicle cream percentage, then generic fluorouracil cream and Carac (fluorouracil) cream were considered to be therapeutically equivalent.|Mean Difference (Net)|0.04|||||TWO_SIDED|90.0|-11.03|11.11|||||90% Wald's confidence interval with a continuity correction for the difference (Generic Fluorouracil Cream - Carac \[Fluorouracil\] Cream) in complete clearance rates.|||11.11|-11.03|
91791640|NCT02616601|183461090|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91658668|NCT00377260|183210796|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.||||.01
91658669|NCT01391793|183210828|SUPERIORITY|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.||||0.16
91658670|NCT01391793|183210829|SUPERIORITY|||||||0.25|||||||Test of equality - 2 Poisson parameters|The method used is a conditional test.||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.||||0.25
91658671|NCT01391793|183210830|SUPERIORITY|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.||||0.07
91658672|NCT01015625|183210831|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.77||||0.042|TWO_SIDED|95.0|1.01|3.09|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter overall survival time for surgery relative to no surgery.|To determine the effect of local therapy (surgery, Arm A) compared to systemic therapy only (Arm B) in synchronous metastasized breast cancer patients in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause. Participants last known to be alive were censored at their last contact date or at the data cut-off date whichever came first.||3.09|1.01|0.042
91658673|NCT01015625|183210832|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.45||||0.147|TWO_SIDED|95.0|0.87|2.42|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to distant progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to distant progression. Distant progression is defined as detection of new lesions or progression of existing metastases in locations different then breast. Participants last known to be alive without a distant progression were censored at their last contact date or at the data cut-off date whichever came first.||2.42|0.87|0.147
91524645|NCT01313286|182924314|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.18|||||TWO_SIDED|90.0|1.07|1.31|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.31|1.07|
91658674|NCT01015625|183210833|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|0.95||||0.89|TWO_SIDED|95.0|0.45|2.02|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to local progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to local progression. Local progression is defined as recurrence in breast with localization mamma, chest wall or axilla. Participants last known to be alive, who did not experience a local progression were censored at their last contact date or at the data cut-off date whichever came first.||2.02|0.45|0.890
91658675|NCT01212874|183210866|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
91658676|NCT01212874|183210867|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91713026|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|0.6|||||TWO_SIDED|95.0|0.3|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.30|
91658677|NCT00105196|183210896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.73|||<|0.001||95.0|-5.44|-2.02|||t-test, 2 sided|||The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.||-2.02|-5.44|<0.001
91658678|NCT00105196|183210897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.075||95.0|-0.88|0.04|||t-test, 2 sided|||To protect the overall (primary and key secondary efficacy analysis) alpha level of 0.05, for this key secondary endpoint a hierarchical testing procedure was followed such that formal testing would take place conditional on the primary efficacy analysis showing a statistically significant difference.||0.04|-0.88|0.075
91713027|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.57|||||TWO_SIDED|95.0|0.84|2.94|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.94|0.84|
91713028|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.81|2.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.73|0.81|
91713029|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.44|||||TWO_SIDED|95.0|0.84|2.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.47|0.84|
91713030|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.63|1.78|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.78|0.63|
91713031|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.85|||||TWO_SIDED|95.0|0.95|3.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.61|0.95|
91713032|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|3.1|||||TWO_SIDED|95.0|1.64|5.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.86|1.64|
91713033|NCT03311841|183317589|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.95|3.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.24|0.95|
91713034|NCT05464420|183317603|OTHER|Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|6.0|||||TWO_SIDED|95.0|3.0|8.6||||||Injection site erythema: V116 Combined Lots - PPSV23||8.6|3.0|
91791641|NCT02616601|183461090|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91713035|NCT05464420|183317603|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|12.6|||||TWO_SIDED|95.0|8.0|17.3||||||Injection site pain: V116 Combined Lots - PPSV23||17.3|8.0|
91713036|NCT05464420|183317603|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.6|||||TWO_SIDED|95.0|2.6|8.2||||||Injection site swelling: V116 Combined Lots - PPSV23||8.2|2.6|
91791642|NCT00718081|183461095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.48|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
91658679|NCT00105196|183210898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.052||95.0|-1.06|0.0||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.00|-1.06|0.052
91713037|NCT05464420|183317605|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||Fatigue: V116 Combined Lots - PPSV23||6.0|-3.2|
91713038|NCT05464420|183317605|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.8|||||TWO_SIDED|95.0|1.6|9.7||||||Headache: V116 Combined Lots - PPSV23||9.7|1.6|
91791643|NCT00718081|183461095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.62|STANDARD_ERROR_OF_MEAN|4.86|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
91524646|NCT02439749|182924353|SUPERIORITY||||||<|0.001||||||p\<0.05 required for significance|ANCOVA|||||||<0.001
91524647|NCT02439749|182924357|SUPERIORITY|||||||0.026||||||p\<0.05 required for significance.|ANCOVA|||||||0.026
91658680|NCT00105196|183210899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.037||95.0|-1.1|-0.03||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||-0.03|-1.10|0.037
91791644|NCT01931670|183461131|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
91791645|NCT01931670|183461131|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
91658681|NCT00105196|183210900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.792||95.0|-0.67|0.51||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.51|-0.67|0.792
91658682|NCT00105196|183210901|SUPERIORITY_OR_OTHER||Ratio of response|1.74|||<|0.001||95.0|1.31|2.32||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.32|1.31|<0.001
91658683|NCT00105196|183210902|SUPERIORITY_OR_OTHER||Ratio of response|1.43|||<|0.001||95.0|1.17|1.74||No adjustment for multiple comparisons was implemented for this secondary endpoint.|ANCOVA||aripiprazole/placebo|||1.74|1.17|<0.001
91658684|NCT00105196|183210903|SUPERIORITY_OR_OTHER||Ratio of remission|1.95|||<|0.001||95.0|1.36|2.8||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.80|1.36|<0.001
91658685|NCT01874951|183210944|NON_INFERIORITY_OR_EQUIVALENCE|An initial power analysis at the time of protocol development suggested that with 6 patients in each treatment group, we could expect a 79% chance of achieving significance (2-sided p \< 0.05) if the true response rate to low-dose naltrexone (LDN) was 80% and the true placebo response rate was 20%.||||||0.55||||||Threshold of statistical significance is 0.05.|Chi-squared|Chi-squared value was 1.5.||Response rates were based on attaining a reduction in the HAM-D-17 scale of 50% or greater compared to baseline. We hypothesized that naltrexone would produce a significantly greater response rate than placebo.||||0.55
91658686|NCT01375660|183210969|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||ANOVA|||||||0.026
91658687|NCT01375660|183210970|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||||||0.6
91658688|NCT01375660|183210971|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||ANOVA|||||||0.389
91658689|NCT01375660|183210972|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||P Value for Insulinogenic Index-30 = 0.34|ANOVA|||||||0.34
91658690|NCT01375660|183210973|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
91658691|NCT01375660|183210974|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
91658692|NCT01375660|183210975|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||Chi-squared|||||||0.869
91658693|NCT05327491|183210978|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.962|||||TWO_SIDED|90.0|0.88|1.053||||||||1.053|0.880|
91658694|NCT05327491|183210979|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.968|||||TWO_SIDED|90.0|0.907|1.033||||||||1.033|0.907|
91658695|NCT05327491|183210980|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.967|||||TWO_SIDED|90.0|0.908|1.029||||||||1.029|0.908|
91658696|NCT00615069|183211044|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0|||||Log Rank|||Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.||||0.003
91524648|NCT02439749|182924358|SUPERIORITY|||||||0.052||||||p\<0.05 required for significance.|ANCOVA|||||||0.052
91658697|NCT00615069|183211045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.428|3.603||||||Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.||3.603|0.428|
91658698|NCT00259012|183211078|SUPERIORITY_OR_OTHER|||||||0.087|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.087
91658699|NCT00259012|183211078|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.019
91658700|NCT00259012|183211079|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.255
91658701|NCT00259012|183211079|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline.||||0.031
91658702|NCT00259012|183211080|SUPERIORITY_OR_OTHER|||||||0.099|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.099
91658703|NCT00259012|183211080|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.016
91524649|NCT02439749|182924359|SUPERIORITY|||||||0.07||||||p\<0.05 required for significance.|ANCOVA|||||||0.070
91658704|NCT00259012|183211081|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.347
91658705|NCT00259012|183211081|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.012
91658706|NCT00259012|183211082|SUPERIORITY_OR_OTHER|||||||0.339|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.339
91658707|NCT00259012|183211082|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.003
91658708|NCT00259012|183211083|SUPERIORITY_OR_OTHER|||||||0.982|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.982
91658709|NCT00259012|183211083|SUPERIORITY_OR_OTHER|||||||0.534|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.534
91658710|NCT00259012|183211084|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.166
91658711|NCT00259012|183211084|SUPERIORITY_OR_OTHER|||||||0.119|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.119
91658712|NCT00259012|183211085|SUPERIORITY_OR_OTHER|||||||0.387|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.387
91658713|NCT00259012|183211085|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.021
91658714|NCT00819507|183211094|SUPERIORITY||Mean Difference (Final Values)|6.01|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91658715|NCT00819507|183211095|SUPERIORITY||Median Difference (Final Values)|14.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91658716|NCT02495467|183211120|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.0132|TWO_SIDED|95.0|0.22|1.84|||Mixed Models Analysis|||||1.84|0.22|0.0132
91658717|NCT02495467|183211121|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0122|TWO_SIDED|95.0|0.09|0.73|||Mixed Models Analysis|||||0.73|0.09|0.0122
91658718|NCT02495467|183211122|SUPERIORITY||Mean Difference (Final Values)|0.39|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Mixed Models Analysis|||||0.57|0.21|<0.0001
91619403|NCT06704178|183131521|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658719|NCT02495467|183211123|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0055|TWO_SIDED|95.0|0.12|0.69|||Mixed Models Analysis|||||0.69|0.12|0.0055
91658720|NCT02495467|183211124|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.001|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||||0.76|0.20|0.001
91658721|NCT02495467|183211125|SUPERIORITY||Means ratio|0.995||||0.7999|TWO_SIDED|95.0|0.96|1.032|||Generalized Linear Mixed Model|||||1.032|0.960|0.7999
91619404|NCT06704178|183131521|SUPERIORITY||||||>|0.9999||||||Month 3 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91658722|NCT02495467|183211126|SUPERIORITY||Means ratio|0.989||||0.6746|TWO_SIDED|95.0|0.937|1.043|||Generalized Linear Mixed Model|||||1.043|0.937|0.6746
91658723|NCT02495467|183211127|SUPERIORITY||Means ratio|1.075||||0.0959|TWO_SIDED|95.0|0.987|1.17|||Generalized Linear Mixed Model|||||1.170|0.987|0.0959
91658724|NCT02495467|183211128|SUPERIORITY||Means ratio|1.522|||<|0.0001|TWO_SIDED|95.0|1.267|1.829|||Generalized Linear Mixed Model|||||1.829|1.267|<0.0001
91791646|NCT01931670|183461132|SUPERIORITY|||||||0.003||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||0.003
91791647|NCT01931670|183461132|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
91791648|NCT01931670|183461133|SUPERIORITY||Difference in LS Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||<0.001
91791649|NCT01931670|183461133|SUPERIORITY||Difference in LS Mean Change|-1.22|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
91658725|NCT02495467|183211129|SUPERIORITY||Means ratio|1.32||||0.0005|TWO_SIDED|95.0|1.128|1.545|||Generalized Linear Mixed Model|||||1.545|1.128|0.0005
91791650|NCT01931670|183461134|SUPERIORITY||Difference in LS Mean Change|-0.54|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
91619405|NCT06704178|183131521|SUPERIORITY||||||>|0.9999||||||Month 4 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619406|NCT06704178|183131521|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619407|NCT06704178|183131521|SUPERIORITY||||||>|0.9999||||||Month 6 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619408|NCT06704178|183131522|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619409|NCT06704178|183131522|SUPERIORITY|||||||0.9951||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9951
91658726|NCT02495467|183211130|SUPERIORITY||||||<|0.0001|||||||Prescott Test (Exact)|||||||<0.0001
91658727|NCT02495467|183211131|SUPERIORITY|||||||0.0003|||||||Prescott Test (Exact)|||||||0.0003
91658728|NCT00834756|183211132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.0||||||90.0|87.96|104.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.78|87.96|
91658729|NCT00834756|183211133|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.63||||||90.0|92.34|105.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.35|92.34|
91658730|NCT00834756|183211134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.37||||||90.0|93.95|107.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.21|93.95|
91658731|NCT03611608|183211196|SUPERIORITY||Mean Difference (Final Values)|263.54|||<|0.001|ONE_SIDED|90.0|207.86||||t-test, 1 sided||||||207.86|<0.001
91524650|NCT02439749|182924360|SUPERIORITY|||||||0.009||||||p=\<0.05 required for significance.|ANCOVA|||||||0.009
91524651|NCT01806584|182924373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|||||p-value based on log rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.138
91524652|NCT01806584|182924374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.312
91619410|NCT06704178|183131522|SUPERIORITY|||||||0.999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||0.999
91619411|NCT06704178|183131522|SUPERIORITY|||||||0.9913||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9913
91619412|NCT06704178|183131522|SUPERIORITY|||||||0.4517||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4517
91619413|NCT06704178|183131522|SUPERIORITY|||||||0.8187||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8187
91619414|NCT06704178|183131523|SUPERIORITY|||||||0.998||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.998
91619415|NCT06704178|183131523|SUPERIORITY|||||||0.9591||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9591
91619416|NCT06704178|183131523|SUPERIORITY|||||||0.9994||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9994
91713039|NCT05464420|183317605|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|7.6|||||TWO_SIDED|95.0|4.5|10.5||||||Myalgia: V116 Combined Lots - PPSV23||10.5|4.5|
91713040|NCT05464420|183317605|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.8|||||TWO_SIDED|95.0|-1.0|2.1||||||Pyrexia: V116 Combined Lots - PPSV23||2.1|-1.0|
91524653|NCT01806584|182924375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.093
91524654|NCT01806584|182924376|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.23|||||TWO_SIDED|95.0|-0.942|1.402||||||||1.402|-0.942|
91524655|NCT01265030|182924409|SUPERIORITY||Mean Difference (Net)|0.75||||0.63|TWO_SIDED|95.0|-2.54|4.04|||t-test, 2 sided|||||4.04|-2.54|0.63
91524656|NCT01265030|182924409|SUPERIORITY||Mean Difference (Net)|-1.95||||0.31|TWO_SIDED|95.0|-6.08|2.19|||t-test, 2 sided|||||2.19|-6.08|0.31
91619417|NCT06704178|183131523|SUPERIORITY|||||||0.9936||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9936
91619418|NCT06704178|183131523|SUPERIORITY|||||||0.8526||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8526
91619419|NCT06704178|183131523|SUPERIORITY|||||||0.4375||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4375
91619420|NCT06704178|183131524|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619421|NCT06704178|183131524|SUPERIORITY|||||||0.7477||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.7477
91619422|NCT06704178|183131524|SUPERIORITY|||||||0.297||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
91619423|NCT06704178|183131524|SUPERIORITY|||||||0.3503||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
91619424|NCT06704178|183131524|SUPERIORITY|||||||0.297||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
91619425|NCT06704178|183131524|SUPERIORITY|||||||0.4449||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
91619426|NCT06704178|183131525|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619427|NCT06704178|183131525|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619428|NCT06704178|183131525|SUPERIORITY|||||||0.9188||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9188
91619429|NCT06704178|183131525|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619430|NCT06704178|183131525|SUPERIORITY|||||||0.3503||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
91619431|NCT06704178|183131525|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
91619432|NCT00961662|183131541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode||||<0.05
91619433|NCT01042613|183131547|SUPERIORITY_OR_OTHER||Difference of the Binomial Proportions|0.02||||0.851||95.0|||||Fisher Exact|||||||.851
91619434|NCT01042613|183131548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||.105
91619435|NCT01042613|183131549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||.8
91619436|NCT02568345|183131550|SUPERIORITY_OR_OTHER||isotonic regression functions through PA|2.2|||||TWO_SIDED|||||The isotonic regression functions through PAVA algorithm were used (pooled adjacent violators algorithm), to determine the ED90, and bootstrapping to calculate the respective 95% confidence interval with the statistical program R||||||||
91713041|NCT05464420|183317607|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.2||||||Vaccine-related SAEs: V116 Combined Lots - PPSV23||0.2|-0.7|
91658732|NCT04625114|183211199|SUPERIORITY||Mean Difference (Final Values)|1.183||||0.511|TWO_SIDED||||||Mixed Models Analysis|||||||0.511
91658733|NCT04625114|183211200|SUPERIORITY||Cox Proportional Hazard|0.965||||0.921|TWO_SIDED|95.0|0.48|1.942|||Regression, Cox|||||1.942|0.480|0.921
91658734|NCT00986245|183211203|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.4|||<|0.05|||||||Sign test|||The UPDRS-part3 was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
91658735|NCT00986245|183211204|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.0|||<|0.05|||||||Sign test|||The Hoehn and Yahr stage was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
91658736|NCT00986245|183211205|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.3|||<|0.05|||||||Sign test|||"The Overall quality of sleep was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
91658737|NCT00986245|183211206|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.2|||<|0.05|||||||Sign test|||"The Nocturnal off-symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
91658738|NCT00986245|183211207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.05||||||80% power|Sign test|||"The Early morning off symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
91658739|NCT00986245|183211208|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Final Values)|0.1|||<|0.05|||||||Sign test|||"The Epworth sleep scale was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
91658740|NCT00986245|183211209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||<|0.05|||||||Sign test|||||||<0.05
91658741|NCT00854308|183211226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.086||||0.6873|TWO_SIDED|95.0|0.727|1.622|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, Eastern Cooperative Oncology Group (ECOG) performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||1.622|0.727|0.6873
91658742|NCT00854308|183211227|SUPERIORITY_OR_OTHER|||||||0.7101||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.||||0.7101
91619437|NCT03209440|183131551|SUPERIORITY||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.73||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
91619438|NCT03209440|183131551|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|0.74||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
91619439|NCT03209440|183131552|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.49||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
91619440|NCT03209440|183131552|SUPERIORITY||Median Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.5||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
91619441|NCT03209440|183131553|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.72||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
91619442|NCT03209440|183131553|SUPERIORITY||Mean Difference (Net)|0.91|STANDARD_ERROR_OF_MEAN|0.73||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
91619443|NCT03209440|183131554|SUPERIORITY||Odds Ratio, log|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.11|TWO_SIDED||||||Regression, Logistic|||||||0.11
91619444|NCT03209440|183131554|SUPERIORITY||Odds Ratio, log|0.96|STANDARD_ERROR_OF_MEAN|0.64||0.14|TWO_SIDED||||||Regression, Logistic|||||||0.14
91619445|NCT03209440|183131555|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.05
91619446|NCT03209440|183131555|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.46|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.46
91619447|NCT03162055|183131605|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-87.2|STANDARD_ERROR_OF_MEAN|13.3||0.9974|TWO_SIDED|97.5|-117.0|-57.4|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-57.4|-117.0|0.9974
91619448|NCT03162055|183131606|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|13.1||0.0002|TWO_SIDED|97.5|-32.8|25.9|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||25.9|-32.8|0.0002
91619449|NCT03162055|183131607|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.79|2.95|||Regression, Logistic|ln (1/(1-p))=Treatment+baseline FEV1+BR a/s MDI+stratification factor (prior treatment)+region.p=percentage of participants with increase of \>=100 mL.|Estimate of the log odds of being a responder in the GFF treatment group compared to the UV treatment group using a logistic regression.|||2.95|1.79|<0.0001
91619450|NCT03162055|183131608|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|19.4||0.0371|TWO_SIDED|95.0|-53.4|22.9|||Repeated measures analysis|Change from baseline = Treatment + baseline IC + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||22.9|-53.4|0.0371
91658743|NCT00854308|183211228|SUPERIORITY_OR_OTHER|||||||0.3671||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib||||0.3671
91524657|NCT01265030|182924410|SUPERIORITY||Mean Difference (Net)|0.063||||0.68|TWO_SIDED|95.0|-0.286|0.411|||t-test, 2 sided|||The mean difference in pain score at week 1 and before surgery||0.411|-.286|0.68
91619451|NCT03162055|183131609|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -1.0 unit.|Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.59|-0.14|||Repeated measures analysis|TDI focal score = Treatment + Baseline Dyspnea Index + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean TDI focal score over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-0.14|-0.59|<0.0001
91619452|NCT03162055|183131610|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.023||0.0017|TWO_SIDED|95.0|-0.011|0.078|||Repeated measures analysis|Change from baseline = Treatment + baseline EMSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.078|-0.011|0.0017
91619453|NCT03162055|183131611|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0088|TWO_SIDED|95.0|-0.005|0.09|||Repeated measures analysis|Change from baseline = Treatment + baseline NiSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.090|-0.005|0.0088
91619454|NCT03162055|183131612|SUPERIORITY||Least Square Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.2||0.9995|TWO_SIDED|95.0|0.26|1.04|||Repeated measures analysis|Change from baseline =Treatment + baseline rescue a/s MDI use + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.04|0.26|0.9995
91619455|NCT03162055|183131613|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 2.0 unit.|Least Square Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.07|1.11|||Repeated measures analysis|Change from baseline = Treatment + baseline CAT score + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.11|0.07|<0.0001
91619456|NCT03162055|183131614|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|12.8||0.5516|TWO_SIDED|97.5|-30.3|27.0|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||27.0|-30.3|0.5516
91619457|NCT02581865|183131620|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.8||0.4326|TWO_SIDED|95.0|-4.9|2.1|||Mixed Models Analysis|||||2.1|-4.9|0.4326
91524658|NCT00584701|182924433|SUPERIORITY_OR_OTHER||Dfiference in exon expression|1.5|||<|0.001||||||"Expression difference \>\|1.5\| with p-value adjusted for multiple comparisons."|ANCOVA|Between-group gene expression profiles compared between high versus low responders, controlling for age, gender and batch.||||||<.001
91619458|NCT02581865|183131620|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.9||0.1835|TWO_SIDED|95.0|-6.2|1.2|||Mixed Models Analysis|||||1.2|-6.2|0.1835
91619459|NCT02581865|183131621|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3812|TWO_SIDED|95.0|-0.7|0.3|||ANOVA|||||0.3|-0.7|0.3812
91619460|NCT02581865|183131621|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0146|TWO_SIDED|95.0|-1.2|-0.1|||ANOVA|||||-0.1|-1.2|0.0146
91713042|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2||1.24|0.96|<0.001
91713043|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.90|<0.001
91524659|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Univariate analysis.||||||0.0000
91619461|NCT02581865|183131622|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3065|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.3065
91619462|NCT02581865|183131622|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.2052|TWO_SIDED|95.0|-0.7|0.2|||Mixed Models Analysis|||||0.2|-0.7|0.2052
91619463|NCT02581865|183131623|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.2215|TWO_SIDED|95.0|-2.7|0.6|||ANCOVA|||||0.6|-2.7|0.2215
91619464|NCT02581865|183131623|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0566|TWO_SIDED|95.0|-3.3|0.0|||ANCOVA|||||0.0|-3.3|0.0566
91619465|NCT02581865|183131624|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|3.8||0.5689|TWO_SIDED|95.0|-9.8|5.4|||Mixed Models Analysis|||||5.4|-9.8|0.5689
91619466|NCT02581865|183131624|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.0||0.232|TWO_SIDED|95.0|-12.8|3.1|||Mixed Models Analysis|||||3.1|-12.8|0.2320
91619467|NCT02581865|183131625|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.1||0.4515|TWO_SIDED|95.0|-3.0|1.3|||Mixed Models Analysis|||||1.3|-3.0|0.4515
91524660|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.1038|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Multivariate analysis (6 main effects only).||||||0.1038
91619468|NCT02581865|183131625|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6289|TWO_SIDED|95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.6289
91619469|NCT02064205|183131634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|1000.0||0.2918|ONE_SIDED||||||Mixed Models Analysis|||A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)||||0.2918
91619470|NCT02064205|183131635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Mixed Models Analysis|||AUC of hunger scores before preload intake for condition C versus D.||||0.0109
91619471|NCT02064205|183131636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0216||||||GLP-1|Mixed Models Analysis|||A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.||||0.0216
91619472|NCT01640925|183131658|NON_INFERIORITY_OR_EQUIVALENCE|The number of patients needed to achieve 80% power was estimated at 171 using Cox proportional hazards regression (hazard ratio reduction of 0.66; 0.15 probability of infection with control) using a two-sided 5% significance.|Cox Proportional Hazard|0.555||||0.049|TWO_SIDED|95.0|0.309|0.998|||Regression, Cox||Hypothesis: Compared to soap and water daily bathing, 2% chlorhexidine gluconate bathing on ICU admission and every 48 hours during surgical ICU care will decrease the risk of acquiring four hospital-acquired infections in surgical ICU patients.|||0.998|0.309|0.049
91619473|NCT00848250|183131683|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
91619474|NCT00848250|183131684|SUPERIORITY|||||||0.13|||||||ANOVA|Repeated measures||||||0.13
91619475|NCT00848250|183131685|SUPERIORITY|||||||0.02|||||||ANOVA|Repeated measures||||||0.02
91619476|NCT00848250|183131686|SUPERIORITY|||||||0.67|||||||ANOVA|Repeated measures||||||0.67
91619477|NCT00848250|183131688|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-value is for comparison of chest tube output at 24 hours||||0.47
91619478|NCT00848250|183131689|SUPERIORITY|||||||0.41|||||||Fisher Exact|||||||0.41
91619479|NCT01122030|183131691|SUPERIORITY_OR_OTHER|||||||0.0767||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0767
91619480|NCT01122030|183131691|SUPERIORITY_OR_OTHER|||||||0.8727||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8727
91619481|NCT01122030|183131691|SUPERIORITY_OR_OTHER|||||||0.6373||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.6373
91791651|NCT01931670|183461134|SUPERIORITY||Difference in LS Mean Change|-1.13|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
91658744|NCT00854308|183211229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529||||0.0418|TWO_SIDED|95.0|0.284|0.986|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, ECOG performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||0.986|0.284|0.0418
91658745|NCT01390844|183211231|SUPERIORITY_OR_OTHER||Difference in Percentage|34.63|||<|0.0001|TWO_SIDED|95.0|20.24|47.18|||Miettinen and Numinen|||Between-Group Comparison||47.18|20.24|<0.0001
91619482|NCT01122030|183131691|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
91619483|NCT01122030|183131691|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
91619484|NCT01122030|183131691|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
91619485|NCT01122030|183131692|SUPERIORITY_OR_OTHER|||||||0.8982||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8982
91619486|NCT01122030|183131692|SUPERIORITY_OR_OTHER|||||||0.4946||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.4946
91619487|NCT01122030|183131692|SUPERIORITY_OR_OTHER|||||||0.9301||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.9301
91619488|NCT01122030|183131692|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0047
91619489|NCT01122030|183131692|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
91619490|NCT01122030|183131692|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
91619491|NCT01122030|183131693|SUPERIORITY_OR_OTHER|||||||0.1334||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.1334
91619492|NCT01122030|183131693|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.3320
91619493|NCT01122030|183131693|SUPERIORITY_OR_OTHER|||||||0.9371||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.9371
91619494|NCT01122030|183131693|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0002
91619495|NCT01122030|183131693|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
91619496|NCT01122030|183131693|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
91619497|NCT01122030|183131694|SUPERIORITY_OR_OTHER|||||||0.7978||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7978
91658746|NCT01390844|183211232|SUPERIORITY_OR_OTHER||Difference in Percentage|33.83||||0.0063|TWO_SIDED|95.0|10.15|52.18|||Miettinen and Numinen|||Between-Group Comparison||52.18|10.15|0.0063
91658747|NCT01390844|183211233|SUPERIORITY_OR_OTHER||Difference in Percentage|35.05|||<|0.0001|TWO_SIDED|95.0|20.51|47.72|||Miettinen and Numinen|||Between-Group Comparison||47.72|20.51|<0.0001
91619498|NCT01122030|183131694|SUPERIORITY_OR_OTHER|||||||0.7143||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7143
91619499|NCT01122030|183131694|SUPERIORITY_OR_OTHER|||||||0.7531||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7531
91619500|NCT01122030|183131694|SUPERIORITY_OR_OTHER|||||||0.0283||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0283
91619501|NCT01122030|183131694|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
91658748|NCT01390844|183211234|SUPERIORITY_OR_OTHER||Difference in Percentage|33.18||||0.0086|TWO_SIDED|95.0|8.96|51.83|||Miettinen and Numinen|||Between-Group Comparison||51.83|8.96|0.0086
91658749|NCT01390844|183211235|SUPERIORITY_OR_OTHER||Difference in Percentage|29.08|||<|0.001|TWO_SIDED|95.0|15.26|42.22|||Miettinen and Nurminen|||Between-Group Comparison||42.22|15.26|<0.001
91658750|NCT01390844|183211236|SUPERIORITY_OR_OTHER||Difference in Percentage|36.13||||0.004|TWO_SIDED|95.0|12.12|55.01|||Mittienen and Nurminen|||Between-Group Comparison||55.01|12.12|0.004
91713044|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.83|1.06||Identical p-values for the lower and upper bounds.|cLDA Model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.83|<0.001
91658751|NCT02597101|183211260|OTHER|REML mixed model|REML mixed model|0.05|||<|0.05|TWO_SIDED|||||Using REML mixed model analysis, differences between study arms resulting in a p\<0.05 would represent statistically-significant differences.|REML mixed model|||The primary efficacy endpoint is the improvement of insulin sensitivity by 40% or greater at 6 months compared to baseline, assessed by the hyperinsulinemic-euglycemic clamp method.||||<0.05
91658752|NCT02079766|183211269|OTHER|||||||0.2959||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|Fisher Exact|||Evaluated the association between the overall brain uptake and the study group||||0.2959
91713045|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.97|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.35|0.97|<0.001
91713046|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.88|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.22|0.88|<0.001
91713047|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.06||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.77|<0.001
91713048|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|1.01|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 7F: V116 Lot 1/ V116 Lot 2||1.34|1.01|<0.001
91713049|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.94|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3||1.25|0.94|<0.001
91713050|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3||1.07|0.81|<0.001
91658753|NCT02079766|183211270|OTHER|||||||0.5163||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|ANOVA|MMSE score as the response variable and flortaucipir uptake score (4 levels) as the fixed effect||Measured differences in clinical presentation using MMSE between subjects with no visual flortaucipir uptake, and those with mild uptake.||||0.5163
91658754|NCT03252353|183211271|SUPERIORITY|||||||0.0079|||||||Regression, Logistic|The adjusted proportion of responders is 58.16 for Octreotide Capsule Treatment Group vs. 19.42 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0079
91713051|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.92|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 8 V116 Lot 1/V116 Lot 2||1.16|0.92|<0.001
91713052|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.93|<0.001
91713053|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3||1.14|0.90|<0.001
91713054|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2||1.26|0.94|<0.001
91619502|NCT01122030|183131694|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
91619503|NCT01122030|183131695|SUPERIORITY_OR_OTHER|||||||0.6269||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6269
91619504|NCT01122030|183131695|SUPERIORITY_OR_OTHER|||||||0.7456||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7456
91619505|NCT01122030|183131695|SUPERIORITY_OR_OTHER|||||||0.1968||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.1968
91619506|NCT01122030|183131695|SUPERIORITY_OR_OTHER|||||||0.8708||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.8708
91619507|NCT01122030|183131695|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
91619508|NCT01122030|183131695|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0002
91619509|NCT01122030|183131696|SUPERIORITY_OR_OTHER|||||||0.6131||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6131
91619510|NCT01122030|183131696|SUPERIORITY_OR_OTHER|||||||0.9293||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.9293
91619511|NCT01122030|183131696|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7990
91619512|NCT01122030|183131696|SUPERIORITY_OR_OTHER|||||||0.7674||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7674
91619513|NCT01122030|183131696|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
91619514|NCT01122030|183131696|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0018
91619515|NCT01122030|183131697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.7434|TWO_SIDED|95.0|0.42|3.92|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||3.92|0.42|0.7434
91791652|NCT01931670|183461135|SUPERIORITY||Difference in LS Mean Change|-0.15|STANDARD_ERROR_OF_MEAN|0.056||0.009|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.009
91791653|NCT01931670|183461135|SUPERIORITY||Difference in LS Mean Change|-0.32|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
91619516|NCT01122030|183131697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.4449|TWO_SIDED|95.0|0.54|4.42|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||4.42|0.54|0.4449
91619517|NCT01122030|183131697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8129|TWO_SIDED|95.0|0.27|2.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||2.72|0.27|0.8129
91619518|NCT01122030|183131697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.52||||0.0005|TWO_SIDED|95.0|2.29|24.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||24.72|2.29|0.0005
91619519|NCT01122030|183131697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.93|||<|0.0001|TWO_SIDED|95.0|3.09|31.89|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||31.89|3.09|<0.0001
91619520|NCT01122030|183131697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|202272814.0|||<|0.0001||95.0|||||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
91619521|NCT01122030|183131698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.4923|TWO_SIDED|95.0|0.53|4.28|||Log Rank|P-values are from the log rank test stratified by gender.||||4.28|0.53|0.4923
91619522|NCT01122030|183131698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.5479|TWO_SIDED|95.0|0.52|4.06|||Log Rank|P-values are from the log rank test stratified by gender.||||4.06|0.52|0.5479
91619523|NCT01122030|183131698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.506|TWO_SIDED|95.0|0.56|3.67|||Log Rank|P-values are from the log rank test stratified by gender.||||3.67|0.56|0.5060
91619524|NCT01122030|183131698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.36||||0.0005|TWO_SIDED|95.0|2.27|23.9|||Log Rank|P-values are from the log rank test stratified by gender.||||23.90|2.27|0.0005
91619525|NCT01122030|183131698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.54|||<|0.0001|TWO_SIDED|95.0|3.0|30.35|||Log Rank|P-values are from the log rank test stratified by gender.||||30.35|3.00|<0.0001
91791654|NCT01931670|183461136|SUPERIORITY||Difference in LS Mean Change|-0.05|STANDARD_ERROR_OF_MEAN|0.044||0.26|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.26
91619526|NCT01122030|183131698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|192233779.0|||<|0.0001||95.0|||||Log Rank|P-values are from the log rank test stratified by gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
91524661|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.0588|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Univariate analysis.||||||0.0588
91619527|NCT01122030|183131699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.45||||0.1523|TWO_SIDED|95.0|0.62|19.35|||Log Rank|P-values are from the log rank test stratified by gender.||||19.35|0.62|0.1523
91619528|NCT01122030|183131699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.55||||0.0856|TWO_SIDED|95.0|0.76|27.07|||Log Rank|P-values are from the log rank test stratified by gender.||||27.07|0.76|0.0856
91619529|NCT01122030|183131699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.81||||0.5284|TWO_SIDED|95.0|0.3|10.98|||Log Rank|P-values are from the log rank test stratified by gender.||||10.98|0.30|0.5284
91619530|NCT01122030|183131699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8594|TWO_SIDED|95.0|0.09|8.66|||Log Rank|P-values are from the log rank test stratified by gender.||||8.66|0.09|0.8594
91619531|NCT01122030|183131699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|59.34|||<|0.0001|TWO_SIDED|95.0|6.55|537.38|||Log Rank|P-values are from the log rank test stratified by gender.||||537.38|6.55|<0.0001
91619532|NCT01122030|183131699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.99||||0.0007|TWO_SIDED|95.0|2.3|52.57|||Log Rank|P-values are from the log rank test stratified by gender.||||52.57|2.30|0.0007
91619533|NCT01122030|183131701|SUPERIORITY_OR_OTHER|||||||0.5054||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.5054
91619534|NCT01122030|183131701|SUPERIORITY_OR_OTHER|||||||0.9688||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9688
91619535|NCT01122030|183131701|SUPERIORITY_OR_OTHER|||||||0.6963||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.6963
91619536|NCT01122030|183131701|SUPERIORITY_OR_OTHER|||||||0.9599||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9599
91619537|NCT01122030|183131701|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0001
91619538|NCT01122030|183131701|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
91524662|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.4802|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Multivariate analysis (6 main effects only).||||||0.4802
91619539|NCT01122030|183131702|SUPERIORITY_OR_OTHER|||||||0.3441||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.3441
91619540|NCT01122030|183131702|SUPERIORITY_OR_OTHER|||||||0.7159||95.0||||P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|ANCOVA|||||||0.7159
91619541|NCT01122030|183131702|SUPERIORITY_OR_OTHER|||||||0.7342||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.7342
91619542|NCT01122030|183131702|SUPERIORITY_OR_OTHER|||||||0.8714||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.8714
91619543|NCT01122030|183131702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||<0.0001
91619544|NCT01122030|183131702|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
91658755|NCT03252353|183211272|SUPERIORITY|||||||0.0007|||||||Regression, Logistic|The adjusted proportion of responders is 77.66 for Octreotide Capsule Treatment Group vs. 30.40 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0007
91658756|NCT03252353|183211273|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
91658757|NCT01918800|183211280|SUPERIORITY_OR_OTHER|||||||0.64||||||No adjustment for multiple comparisons. A priori threshold for clinical significance was 7 point improvement.|paired t test|||||||.64
91658758|NCT01918800|183211281|SUPERIORITY_OR_OTHER|||||||0.04||||||No adjustments for multiple comparisons.|paired t test|||||||0.04
91658759|NCT01918800|183211282|SUPERIORITY_OR_OTHER|||||||0.35||||||No adjustment for multiple comparisons|Paired t test|||||||0.35
91658760|NCT01918800|183211283|SUPERIORITY|||||||0.8||||||The p value in this case is for the SF-36 Physical|Wilcoxon (Mann-Whitney)|||||||0.8
91658761|NCT01918800|183211283|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||The p value in this case refers to the SF-36 Mental||||.09
91658762|NCT01918800|183211284|SUPERIORITY_OR_OTHER|||||||0.521||||||This p value applies to the RAPA Cardiovascular|Wilcoxon (Mann-Whitney)|||||||0.521
91658763|NCT01918800|183211284|SUPERIORITY|||||||0.4199|||||||Wilcoxon (Mann-Whitney)|||This p values is for the RAPA Strength||||0.4199
91658764|NCT01918800|183211284|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
91658765|NCT01918800|183211285|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91658766|NCT01918800|183211286|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91658767|NCT03018249|183211287|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91658768|NCT03018249|183211288|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-25.0|30.0||||||||30|-25|
91658769|NCT03018249|183211289|SUPERIORITY||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|-16.7|45.3||||||||45.3|-16.7|
91658770|NCT00323193|183211305|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANOVA|||||||.720
91619545|NCT02883049|183131716|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.893|TWO_SIDED|95.0|0.74|1.413|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.||1.413|0.74|0.893
91619546|NCT02883049|183131717|SUPERIORITY||Hazard Ratio (HR)|1.019||||0.556|ONE_SIDED|97.5||1.335|||Log Rank||Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm|To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.||1.335||0.556
91619547|NCT03575884|183131733|SUPERIORITY||Study_arm timepoint interactions|-27.32|||<|0.05|TWO_SIDED|95.0|-52.49|-2.14|||Mixed Models Analysis|||||-2.14|-52.49|<0.05
91619548|NCT03888391|183131762|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|Time: F = 1.72, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.20
91619549|NCT03888391|183131764|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 44.47, df = 1/33||Outcomes fitted via a mixed model with time as a predictor.||||<.0001
91619550|NCT03888391|183131765|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F = 15.74, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.0004
91619551|NCT03888391|183131766|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Time: F = .28, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.60
91619552|NCT03888391|183131767|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|Time: F = 1.04, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.32
91619553|NCT03888391|183131768|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|Time: F = 1.27, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.27
91619554|NCT03615469|183131810|OTHER|t-test||||||0.22|||||||t-test, 2 sided|||||||0.22
91658771|NCT00323193|183211306|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||.710
91658772|NCT03929367|183211456|OTHER|Modeling of change of plasma oxytocin concentration over time using nonlinear canonical compartment model.|Bayesian information criterion|2.0|||||TWO_SIDED|||||||||||||
91658773|NCT03929367|183211467|SUPERIORITY|Light touch detection frequency was compared over time in comparison to baseline using a one way analysis of variance for repeated measures. A power analysis was not performed for this secondary outcome measure.||||||0.89||||||No effect|ANOVA|||||||.89
91658774|NCT03929367|183211474|SUPERIORITY|Sustained heat score at the end of each 5 minute session was compared to baseline across time using a one-way analysis of variance for repeated measures. Power analysis was not performed for this secondary outcome measure.||||||0.014|||||||ANOVA|||||||0.014
91658775|NCT00515203|183211493|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
91619555|NCT05373706|183131812|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.20|0.76|0.68
91619556|NCT05373706|183131812|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.1||||0.56|TWO_SIDED|95.0|0.81|1.49|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.49|0.81|0.56
91619557|NCT05373706|183131813|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.93||||0.68|TWO_SIDED|95.0|0.64|1.33|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.33|0.64|0.68
91619558|NCT05373706|183131813|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.24||||0.3|TWO_SIDED|95.0|0.82|1.88|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.88|0.82|0.30
91619559|NCT05373706|183131814|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.89||||0.36|TWO_SIDED|95.0|0.69|1.15|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.15|0.69|0.36
91658776|NCT00515203|183211494|SUPERIORITY_OR_OTHER|||||||0.3651|||||||Cochran-Mantel-Haenszel|||||||0.3651
91658777|NCT00515203|183211495|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
91658778|NCT00515203|183211496|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
91658779|NCT00515203|183211497|SUPERIORITY_OR_OTHER|||||||0.2098|||||||Fisher Exact|||||||0.2098
91658780|NCT01706536|183211510|SUPERIORITY||Least Squares Mean (SE)|0.1168|STANDARD_ERROR_OF_MEAN|0.04055||0.0043|TWO_SIDED|95.0|0.0369|0.1966|||Least squares mean (SE)|In order to control for Type I error rate, a gate keeping methodology was used.||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.1966|0.0369|0.0043
91619560|NCT05373706|183131814|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.05||||0.73|TWO_SIDED|95.0|0.8|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.80|0.73
91619561|NCT05373706|183131815|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.83||||0.11|TWO_SIDED|95.0|0.66|1.04|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.04|0.66|0.11
91619562|NCT05373706|183131815|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.17|0.66|0.38
91658781|NCT01706536|183211510|SUPERIORITY||Least Squares Mean (SE)|0.1284|STANDARD_ERROR_OF_MEAN|0.04089||0.0019|TWO_SIDED|95.0|0.0479|0.2089||In order to control for Type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2089|0.0479|0.0019
91658782|NCT01706536|183211510|SUPERIORITY||Least Squares Mean (SE)|0.1462|STANDARD_ERROR_OF_MEAN|0.04037||0.0004|TWO_SIDED|95.0|0.0667|0.2257||in order to control for Type 1 error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2257|0.0667|0.0004
91658783|NCT01706536|183211510|SUPERIORITY||Least Squares Mean (SE)|0.177|STANDARD_ERROR_OF_MEAN|0.03953|<|0.0001|TWO_SIDED|95.0|0.0992|0.2548||in order to control for type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2548|0.0992|<0.0001
91658784|NCT04753437|183211524|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric Least Squares (LS) Mean Ratio|1.3|||||TWO_SIDED|90.0|0.94|1.81||||||||1.81|0.94|
91658785|NCT04753437|183211525|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.82|1.4||||||||1.40|0.82|
91619563|NCT05086289|183131821|SUPERIORITY||Posterior Mean Difference|-0.38|||||TWO_SIDED|95.0|-0.89|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.89|
91619564|NCT05086289|183131822|SUPERIORITY||Posterior Mean Difference|-0.28|||||TWO_SIDED|95.0|-0.85|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.85|
91619565|NCT05086289|183131823|SUPERIORITY||Posterior Mean Difference|-0.62|||||TWO_SIDED|95.0|-1.91|0.68|||||Posterior mean difference with 95% credible interval is reported.|||0.68|-1.91|
91619566|NCT05086289|183131824|SUPERIORITY||Posterior Mean Difference|-1.17|||||TWO_SIDED|95.0|-2.54|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-2.54|
91619567|NCT05086289|183131825|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.44|0.19|||||Posterior mean difference with 95% credible interval is reported.|||0.19|-0.44|
91619568|NCT05086289|183131826|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.67|0.14|||||Posterior mean difference with 95% credible interval is reported.|||0.14|-0.67|
91658786|NCT03567174|183211563|SUPERIORITY||Mean Difference (Net)|-0.306||||0.125|TWO_SIDED|95.0|-0.697|0.085|||Mixed Models Analysis|||||0.085|-0.697|0.125
91658787|NCT02158936|183211585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||1|TWO_SIDED|95.0|0.21|0.65||One sided p value|Cochran-Mantel-Haenszel|Stratified by Interactive Voice Response System (IVRS) stratification factors||||0.65|0.21|1.000
91619569|NCT05086289|183131827|SUPERIORITY||Posterior Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.05|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-1.05|
91619570|NCT05086289|183131828|SUPERIORITY||Posterior Mean Difference|-0.51|||||TWO_SIDED|95.0|-1.17|0.16|||||Posterior mean difference with 95% credible interval is reported.|||0.16|-1.17|
91619571|NCT05086289|183131829|SUPERIORITY||Posterior Mean Difference|-4.95|||||TWO_SIDED|95.0|-11.07|1.27|||||Posterior mean difference with 95% credible interval is reported.|||1.27|-11.07|
91619572|NCT05086289|183131830|SUPERIORITY||Posterior Mean Difference|-4.78|||||TWO_SIDED|95.0|-11.73|2.15|||||Posterior mean difference with 95% credible interval is reported.|||2.15|-11.73|
91619573|NCT05086289|183131831|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.46|0.21|||||Posterior mean difference with 95% credible interval is reported.|||0.21|-0.46|
91619574|NCT05086289|183131832|SUPERIORITY||Posterior Mean Difference|1.52|||||TWO_SIDED|95.0|-6.2|9.2|||||Posterior mean difference with 95% credible interval is reported.|||9.20|-6.20|
91619575|NCT05086289|183131833|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.06|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.06|
91619576|NCT05086289|183131834|SUPERIORITY||Posterior Mean Difference|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Posterior mean difference with 95% credible interval is reported.|||0.10|-0.05|
91619577|NCT05086289|183131835|SUPERIORITY||Posterior Mean Difference|41.72|||||TWO_SIDED|95.0|-95.92|179.76|||||Posterior mean difference with 95% credible interval is reported.|||179.76|-95.92|
91619578|NCT05086289|183131836|SUPERIORITY||Posterior Mean Difference|9.73|||||TWO_SIDED|95.0|-151.11|170.52|||||Posterior mean difference with 95% credible interval is reported.|||170.52|-151.11|
91619579|NCT03150108|183131837|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% confidence interval (CI).|Geometric mean ratio|1.119|||||TWO_SIDED|90.0|0.875|1.43||||||||1.430|0.875|
91619580|NCT03150108|183131837|OTHER|Dose proportionality|Increase in Cmax per Dose Doubling|1.76|||||TWO_SIDED|90.0|1.52|2.03|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted Cmax using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.03|1.52|
91619581|NCT03150108|183131839|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUClast values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.8|1.23||||||||1.23|0.80|
91619582|NCT03150108|183131839|OTHER|Dose proportionality|Increase in AUClast per Dose Doubling|2.35||||||90.0|2.06|2.7|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUClast using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.70|2.06|
91619583|NCT03150108|183131840|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-8 values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.87|1.35||||||||1.35|0.87|
91619584|NCT03150108|183131840|OTHER|Dose proportionality|Increase in AUC0-8 per Dose Doubling|2.23|||||TWO_SIDED|90.0|1.98|2.51|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-8 using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.51|1.98|
91619585|NCT03150108|183131841|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-inf values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.77|1.33||||||||1.33|0.77|
91658788|NCT02158936|183211586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.164|TWO_SIDED|95.0|0.97|2.08|||Log Rank|||Confidence Intervals estimated using the Brookmeyer-Crowley method. Hazard ratios are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with eltrombopag compared with Placebo. Log-rank test stratified by IVRS stratification factors||2.08|0.97|0.164
91658789|NCT02158936|183211603|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.99|1.74|||ANOVA|||||1.74|0.990|
91658790|NCT02158936|183211604|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|0.97|1.99|||ANOVA|||||1.99|0.970|
91658791|NCT03497897|183211629|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|Posterior geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.64|1.34|||Bayesian analysis|Bayesian mixed effect model with repeated measures|90% credible intervals are reported on the geometric means ratio|||1.34|0.64|
91658792|NCT03497897|183211629|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<1)|0.637|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
91658793|NCT03497897|183211629|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<0.75)|0.171|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
91658794|NCT00723528|183211630|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
91658795|NCT00723528|183211631|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sample t-test (using Holm's method)|t-test, 2 sided|||||||<0.0001
91658796|NCT00723528|183211641|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
91658797|NCT02627924|183211643|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
91658798|NCT02627924|183211644|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
91658799|NCT02627924|183211646|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
91713055|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.87|<0.001
91713056|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.80|<0.001
91658800|NCT02627924|183211646|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
91658801|NCT02627924|183211646|OTHER|||||||0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||0.0001
91713057|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.85|<0.001
91658802|NCT02627924|183211646|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
91658803|NCT02627924|183211647|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
91658804|NCT02627924|183211647|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
91658805|NCT02627924|183211648|OTHER|||||||0.0098|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||0.0098
91658806|NCT02627924|183211648|OTHER|||||||0.0015|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||0.0015
91658807|NCT02627924|183211648|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
91658808|NCT02627924|183211648|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
91658809|NCT03979079|183211665|OTHER||Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.14|0.3||Estimation was performed using a Bayesian approach. As such, p-values are not estimated.|Two-stage model.||||Two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. Prostatespecific antigens modeled using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability was expressed as a function of prostate-specific antigens concentration. Covariates in the survival model included hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.|0.30|0.14|
91658810|NCT00667095|183211670|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.024
91713058|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.91|<0.001
91658811|NCT00667095|183211670|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.036
91658812|NCT00667095|183211671|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.051
91658813|NCT00667095|183211671|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.12
91658814|NCT00667095|183211672|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.42
91713059|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.93|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3||1.21|0.93|<0.001
91713060|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.84|<0.001
91658815|NCT00667095|183211672|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.15
91658816|NCT00667095|183211673|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 1 month||||0.18
91658817|NCT00667095|183211673|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.77
91658818|NCT00667095|183211674|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||Change from baseline to one month||||0.67
91658819|NCT00667095|183211674|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.20
91713061|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3||1.16|0.87|<0.001
91713062|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.9|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.90|<0.001
91658820|NCT00667095|183211675|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Change between baseline and one month||||0.31
91658821|NCT00667095|183211675|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||Change between baseline and 3 months||||0.038
91658822|NCT01520909|183211676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.96|||<|0.001|TWO_SIDED|95.0|2.29|140.93|||Cochran-Mantel-Haenszel|The proportion of participants achieving platelet counts \>=50 Gi/L for those participants receiving eltrombopag versus placebo was compared.||Indicated significance at the 5% (two-sided) level of significance||140.93|2.29|<0.001
91658823|NCT01520909|183211677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.33|||<|0.001|TWO_SIDED|95.0|8.15|78.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized linear mixed model||||78.73|8.15|<0.001
91658824|NCT00840099|183211720|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of Means x 100|100.91||||||90.0|95.82|106.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.26|95.82|
91658825|NCT00840099|183211721|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.79||||||90.0|100.69|104.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.94|100.69|
91658826|NCT00840099|183211722|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.75||||||90.0|100.62|104.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.93|100.62|
91658827|NCT00840099|183211723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the Mean x 100|100.47||||||90.0|93.28|108.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.20|93.28|
91658828|NCT00840099|183211724|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Ratio of the mean|104.15||||||90.0|96.35|112.58|||||Bioequivalence is established when 80% Confidence Interval falls within 80 - 125|||112.58|96.35|
91658829|NCT00840099|183211725|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|104.06||||||90.0|95.85|112.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.97|95.85|
91713063|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2||1.26|0.96|<0.001
91658830|NCT02163837|183211759|SUPERIORITY|the study was exploratory, the number of patients included was not calculated|||||<|0.05|||||||McNemar|||Mc Nemar symetry test for repeated measures and paired t-tests as appropriated||||<0.05
91658831|NCT01171989|183211760|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.84||||||Difference in percentage anti-PRP ≥ 0.15 μg/mL||2.84|-3.27|
91658832|NCT01171989|183211761|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.27|
91658833|NCT01171989|183211761|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.02|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.02|
91658834|NCT03553823|183211830|SUPERIORITY||Difference secukinumab vs guselkumab|20.0||||0.1715|TWO_SIDED|95.0|-13.3|50.3|||Fisher Exact|The statistical model was the Fisher's exact test for the difference in proportions.||"Proportion of subjects whose plaque achieves clear or almost clear status (TCS = 0-2)"||50.3|-13.3|0.1715
91658835|NCT00813293|183211864|SUPERIORITY|||||||0.794|||||||Wilcoxon (Mann-Whitney)|||Assuming the two trial arms were independent, the standard deviation was 0.5cm for both arms and a sample size of 16 evaluable patients (8 per arm), the study had an 84% power at a 5% (two-sided) significance level to detect 0.8cm difference in ablation zone size. In order to allow a 20% drop-out rate, a total of 20 subjects were accrued.||||.794
91658836|NCT02794974|183211869|SUPERIORITY|||||||0.236|||||||Fisher Exact|||||||0.236
91658837|NCT02794974|183211870|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
91658838|NCT02794974|183211871|SUPERIORITY||Odds Ratio|4.5||||0.209|TWO_SIDED|95.0|0.63|32.2|||Odds Ratio|||||32.2|0.63|0.209
91658839|NCT02794974|183211872|SUPERIORITY||Odds Ratio|2.5||||0.44|TWO_SIDED|95.0|0.49|12.77|||Odds Ratio|||||12.77|0.49|0.44
91713064|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
91658840|NCT02794974|183211873|SUPERIORITY||Odds Ratio|1.88||||0.695|TWO_SIDED|95.0|0.37|9.45|||Odds Ratio|||||9.45|0.37|0.695
91658841|NCT02870920|183211874|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.07|TWO_SIDED|90.0|0.54|0.97|||Log Rank|||||0.97|0.54|0.07
91658842|NCT02870920|183211875|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.97|TWO_SIDED|90.0|0.76|1.34|||Log Rank|||||1.34|0.76|0.97
91658843|NCT00533273|183211877|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
91658844|NCT00533273|183211878|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
91658845|NCT00533273|183211879|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91658846|NCT00533273|183211880|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91658847|NCT00533273|183211882|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||.014
91658848|NCT00533273|183211883|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
91658849|NCT00533273|183211884|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91658850|NCT00533273|183211885|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
91658851|NCT00454909|183211896|SUPERIORITY||Difference in percentage|11.2|||||TWO_SIDED|95.0|3.87|19.18||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.||19.18|3.87|
91658852|NCT00454909|183211896|SUPERIORITY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-5.08|0.4||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.||0.40|-5.08|
91658853|NCT00454909|183211896|SUPERIORITY||Difference in percentage|14.93|||||TWO_SIDED|95.0|8.24|22.71||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.||22.71|8.24|
91658854|NCT00454909|183211896|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|7.9|20.1||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.||20.10|7.90|
91658855|NCT02549092|183211919|SUPERIORITY||Least Squares (LS) Mean of Difference|-8.21|STANDARD_ERROR_OF_MEAN|9.91||0.41|TWO_SIDED|95.0|-27.98|11.55||P value is from the mixed model repeated measures (MMRM) with the model: change from Baseline=treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. Unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||11.55|-27.98|0.410
91524663|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.0147
91658856|NCT02549092|183211920|SUPERIORITY||LS Mean of Difference|1.57|STANDARD_ERROR_OF_MEAN|2.37||0.509|TWO_SIDED|95.0|-3.16|6.3||The P value is from the MMRM with the model: change from Baseline = treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. The unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||6.30|-3.16|0.509
91658857|NCT02549092|183211921|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|3.59||0.291|TWO_SIDED|95.0|-10.96|3.34||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||3.34|-10.96|0.291
91658858|NCT02549092|183211922|SUPERIORITY||LS Mean of Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.84|-1.82||Analysis of covariance (ANCOVA) model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-1.82|-2.84|< 0.001
91658859|NCT02549092|183211923|SUPERIORITY||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.99||0.006|TWO_SIDED|95.0|-4.77|-0.81||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-0.81|-4.77|0.006
91658860|NCT02549092|183211924|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.99||0.933|TWO_SIDED|95.0|-1.89|2.06||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Cardiovascular including falls||2.06|-1.89|0.933
91658861|NCT02549092|183211924|SUPERIORITY||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|2.35||0.655|TWO_SIDED|95.0|-3.63|5.74||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sleep/fatigue||5.74|-3.63|0.655
91524664|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.1181|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.1181
91524665|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Univariate analysis.||||||0.0000
91524666|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Multivariate analysis (6 main effects only).||||||0.0006
91658862|NCT02549092|183211924|SUPERIORITY||LS mean difference|-1.85|STANDARD_ERROR_OF_MEAN|3.67||0.616|TWO_SIDED|95.0|-9.18|5.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Mood/cognition||5.48|-9.18|0.616
91524667|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Univariate analysis.||||||0.0004
91658863|NCT02549092|183211924|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.84||0.645|TWO_SIDED|95.0|-1.3|2.08||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Perceptual problems/hallucinations||2.08|-1.30|0.645
91524668|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.3371|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Multivariate analysis (6 main effects only).||||||0.3371
91524669|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Univariate analysis.||||||0.0000
91524670|NCT01250119|182924448|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Multivariate analysis (6 main effects only).||||||0.0001
91658864|NCT02549092|183211924|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|2.04||0.645|TWO_SIDED|95.0|-5.03|3.14||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Attention/memory||3.14|-5.03|0.645
91713065|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.81|<0.001
91791655|NCT01931670|183461136|SUPERIORITY||Difference in LS Mean Change|-0.18|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
91791656|NCT01931670|183461137|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.088|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.088
91619586|NCT03150108|183131841|OTHER|Dose proportionality|Increase in AUC0-inf per Dose Doubling|2.31|||||TWO_SIDED|90.0|1.96|2.71|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-inf using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.71|1.96|
91619587|NCT03150108|183131847|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.13|||||TWO_SIDED|90.0|0.9|1.4||||||||1.40|0.90|
91619588|NCT03150108|183131849|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25||||||||1.25|0.93|
91619589|NCT03238235|183131878|SUPERIORITY||Log Difference of the least square means|0.04||||0.8282|TWO_SIDED|95.0|-0.3|0.38||ANCOVA model was performed considering the difference between log of total fibrosis and log baseline values as dependent variable; log baseline value was included as covariate, treatment and concomitant steroid use as independent class variables.|ANCOVA|||total fibrosis at visit 11||0.38|-0.30|0.8282
91619590|NCT03238235|183131878|SUPERIORITY|Mixed model was performed considering the difference between log Visit 11 and log baseline values as dependent variable; log baseline as covariate, treatment was included as independent class variable and treatment by sequence interaction. The sequence of biopsy site (R-L, L-R) was included as a fixed effect and subject as a random effect. If the treatment by sequence interaction was p\>0.10, then the model without the interaction term is presented.|Log Difference of Least Square Means|-0.11||||0.6465|TWO_SIDED|95.0|-0.59|0.37|||Mixed Models Analysis|||A Mixed Model was fitted to the data in order to evaluate the difference in total fibrosis between biopsy sites||0.37|-0.59|0.6465
91619591|NCT03238235|183131879|SUPERIORITY||Log Difference of Least Square Means|-0.05||||0.1991|TWO_SIDED|95.0|-0.12|0.03||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Vastus lateralis||0.03|-0.12|0.1991
91658865|NCT02549092|183211924|SUPERIORITY||LS mean difference|-2.58|STANDARD_ERROR_OF_MEAN|1.34||0.058|TWO_SIDED|95.0|-5.25|0.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Gastrointestinal tract||0.09|-5.25|0.058
91658866|NCT02549092|183211924|SUPERIORITY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.588|TWO_SIDED|95.0|-5.52|3.15||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Urinary||3.15|-5.52|0.588
91791657|NCT01931670|183461137|SUPERIORITY||Difference in LS Mean Change|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
91791658|NCT01931670|183461138|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.067||0.172|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.172
91791659|NCT01931670|183461138|SUPERIORITY||Difference in LS Mean Change|-0.3|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||< 0.001
91791660|NCT01931670|183461139|SUPERIORITY||Difference in LS Mean Change|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.968|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.968
91658867|NCT02549092|183211924|SUPERIORITY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.05||0.464|TWO_SIDED|95.0|-2.88|1.33||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sexual function||1.33|-2.88|0.464
91658868|NCT02549092|183211924|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.76||0.468|TWO_SIDED|95.0|-4.8|2.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Miscellaneous||2.23|-4.80|0.468
91658869|NCT02549092|183211925|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.26||0.643|TWO_SIDED|95.0|-3.09|1.92||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Motor symptoms at night||1.92|-3.09|0.643
91658870|NCT02549092|183211925|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.82||0.769|TWO_SIDED|95.0|-1.39|1.87||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|PD symptoms at night||1.87|-1.39|0.769
91658871|NCT02549092|183211925|SUPERIORITY||LS Mean of Difference|1.99|STANDARD_ERROR_OF_MEAN|0.84||0.02|TWO_SIDED|95.0|0.32|3.66||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Disturbed sleep||3.66|0.32|0.020
91658872|NCT02549092|183211926|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.46||0.672|TWO_SIDED|95.0|-0.72|1.1||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part I score||1.10|-0.72|0.672
91658873|NCT02549092|183211926|SUPERIORITY||LS Mean of Difference|-2.22|STANDARD_ERROR_OF_MEAN|2.13||0.302|TWO_SIDED|95.0|-6.47|2.04||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part III score||2.04|-6.47|0.302
91658874|NCT02549092|183211926|SUPERIORITY||LS Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.61||0.007|TWO_SIDED|95.0|-2.91|-0.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part IV score||-0.48|-2.91|0.007
91658875|NCT02549092|183211927|SUPERIORITY||LS Mean of Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.5||0.307|TWO_SIDED|95.0|-4.52|1.44||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||1.44|-4.52|0.307
91658876|NCT02549092|183211928|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.46||0.868|TWO_SIDED|95.0|-0.99|0.84||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||0.84|-0.99|0.868
91791661|NCT01931670|183461139|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.007
91658877|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|3.28||0.728|TWO_SIDED|95.0|-7.68|5.39||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Total score||5.39|-7.68|0.728
91658878|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.916|TWO_SIDED|95.0|-1.5|1.35||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Musculoskeletal pain score||1.35|-1.50|0.916
91658879|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.68||0.919|TWO_SIDED|95.0|-1.28|1.42||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Chronic pain score||1.42|-1.28|0.919
91658880|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|1.53||0.68|TWO_SIDED|95.0|-2.42|3.68||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Fluctuation related pain score||3.68|-2.42|0.680
91658881|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.24||0.767|TWO_SIDED|95.0|-2.83|2.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Nocturnal pain score||2.09|-2.83|0.767
91658882|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.51||0.804|TWO_SIDED|95.0|-1.15|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Orofacial pain score||0.90|-1.15|0.804
91658883|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.79||0.025|TWO_SIDED|95.0|-3.38|-0.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Discoloration and edema score||-0.23|-3.38|0.025
91791662|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|2.361|||<|0.001|TWO_SIDED|97.5|1.507|3.697|||Regression, Logistic|||Month 1||3.697|1.507|< 0.001
91791663|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|4.185|||<|0.001|TWO_SIDED|97.5|2.707|6.469|||Regression, Logistic|||Month 1||6.469|2.707|< 0.001
91619592|NCT03238235|183131879|SUPERIORITY||difference of the least square means|-0.27||||0.7849|TWO_SIDED|95.0|-2.22|1.69||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Soleus||1.69|-2.22|0.7849
91619593|NCT03238235|183131880|SUPERIORITY||Difference of Least Square Means|-1.35||||0.0149|TWO_SIDED|95.0|-2.43|-0.28||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole thigh at visit 11||-0.28|-2.43|0.0149
91713066|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2||1.22|0.89|<0.001
91619594|NCT03238235|183131880|SUPERIORITY||Difference of Least Square Means|-1.96||||0.0022|TWO_SIDED|95.0|-3.18|-0.75||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at visit 11||-0.75|-3.18|0.0022
91619595|NCT03238235|183131880|SUPERIORITY||Difference of least square means|-0.58||||0.4869|TWO_SIDED|95.0|-2.24|1.08||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at visit 11||1.08|-2.24|0.4869
91619596|NCT03238235|183131880|SUPERIORITY||Difference of Least Square Means|-1.59||||0.0939|TWO_SIDED|95.0|-3.47|0.29||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||0.29|-3.47|0.0939
91619597|NCT03238235|183131880|SUPERIORITY||Difference of Least Square Means|-0.89||||0.1579|TWO_SIDED|95.0|-2.13|0.36||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis girdle at visit 11||0.36|-2.13|0.1579
91619598|NCT03238235|183131881|SUPERIORITY||Difference of Least Square Means|0.4||||0.777|TWO_SIDED|95.0|-2.45|3.26||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at visit 11||3.26|-2.45|0.7770
91619599|NCT03238235|183131881|SUPERIORITY||Difference of Least Square Means|-0.09||||0.8926|TWO_SIDED|95.0|-1.35|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at Visit 11||1.18|-1.35|0.8926
91619600|NCT03238235|183131881|SUPERIORITY||Difference of Least Square Means|0.35||||0.572|TWO_SIDED|95.0|-0.88|1.58||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Medial Thigh at Visit 11||1.58|-0.88|0.5720
91619601|NCT03238235|183131881|SUPERIORITY||Difference of Least Square Means|0.11||||0.8386|TWO_SIDED|95.0|-0.97|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at Visit 11||1.18|-0.97|0.8386
91619602|NCT03238235|183131881|SUPERIORITY||Difference of Least Square Means|-0.22||||0.8591|TWO_SIDED|95.0|-2.68|2.25||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Triceps Surae at Visit 11||2.25|-2.68|0.8591
91619603|NCT03238235|183131881|SUPERIORITY||Difference of Least Square Means|0.32||||0.7392|TWO_SIDED|95.0|-1.6|2.24|||ANCOVA|||Pelvis Girdle at Visit 11||2.24|-1.60|0.7392
91619604|NCT03238235|183131882|SUPERIORITY||Difference of Least Square Means|1.37||||0.0375|TWO_SIDED|95.0|0.08|2.65||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at Visit 11||2.65|0.08|0.0375
91619605|NCT03238235|183131882|SUPERIORITY||difference of least square means|0.63||||0.0528|TWO_SIDED|95.0|-0.01|1.27||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Quadriceps at Visit 11||1.27|-0.01|0.0528
91791664|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|2.795|||<|0.001|TWO_SIDED|97.5|1.811|4.312|||Regression, Logistic|||Month 2||4.312|1.811|< 0.001
91619606|NCT03238235|183131882|SUPERIORITY||Difference of Least Square Means|0.36||||0.2012|TWO_SIDED|95.0|-0.2|0.91||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Medial Thigh at Visit 11||0.91|-0.20|0.2012
91619607|NCT03238235|183131882|SUPERIORITY||Difference of Least Square Means|0.75||||0.4676|TWO_SIDED|95.0|-1.33|2.83||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||2.83|-1.33|0.4676
91619608|NCT03238235|183131882|SUPERIORITY||Difference of Least Square Means|0.54||||0.1549|TWO_SIDED|95.0|-0.21|1.3||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis Girdle at Visit 11||1.30|-0.21|0.1549
91791665|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|10.378|||<|0.001|TWO_SIDED|97.5|6.615|16.282|||Regression, Logistic|||Month 2||16.282|6.615|< 0.001
91791666|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|3.178|||<|0.001|TWO_SIDED|97.5|2.084|4.845|||Regression, Logistic|||Month 4||4.845|2.084|< 0.001
91791667|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|15.216|||<|0.001|TWO_SIDED|97.5|9.429|24.554|||Regression, Logistic|||Month 4||24.554|9.429|< 0.001
91791668|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|2.548|||<|0.001|TWO_SIDED|97.5|1.683|3.859|||Regression, Logistic|||Month 5||3.859|1.683|< 0.001
91791669|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|14.055|||<|0.001|TWO_SIDED|97.5|8.716|22.664|||Regression, Logistic|||Month 5||22.664|8.716|< 0.001
91791670|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|2.536|||<|0.001|TWO_SIDED|97.5|1.685|3.816|||Regression, Logistic|||Month 6||3.816|1.685|< 0.001
91524671|NCT01559454|182924457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.4167||||0.097|TWO_SIDED|95.0|-8.7519|79.5852|||t-test, 2 sided|||||79.5852|-8.7519|0.097
91619609|NCT03238235|183131883|SUPERIORITY||Difference of Least Square Means|-619.2||||0.324|TWO_SIDED|95.0|-1872.37|633.98||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||CSA Type II at Visit 11||633.98|-1872.37|0.3240
91619610|NCT03238235|183131883|SUPERIORITY||Difference of Least Square Means|-572.54||||0.307|TWO_SIDED|95.0|-1690.73|545.64||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total CSA at Visit 11||545.64|-1690.73|0.3070
91619611|NCT03238235|183131884|SUPERIORITY||Log Difference of Least Square Means|-0.27||||0.1055|TWO_SIDED|95.0|-0.59|0.06||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Fibers with nuclear centralizations (%) at Visit 11||0.06|-0.59|0.1055
91619612|NCT03238235|183131884|SUPERIORITY||Difference of Least Square Means|-2.23||||0.8846|TWO_SIDED|95.0|-33.05|28.59||ANCOVA model was performed considering baseline biopsy histological parameters (Slide II) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Total number of fibers at Visit 11 (slide II)||28.59|-33.05|0.8846
91619613|NCT03238235|183131884|SUPERIORITY||Difference of Least Square Means|4.72||||0.4054|TWO_SIDED|95.0|-6.62|16.06||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total number of fibers (Slide III)||16.06|-6.62|0.4054
91619614|NCT03238235|183131885|SUPERIORITY||Difference of Least Square Means|2.45||||0.634|TWO_SIDED|95.0|-7.87|12.77||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||||12.77|-7.87|0.6340
91619615|NCT03238235|183131886|SUPERIORITY||Log Difference of Least Square Means|-0.14||||0.4893|TWO_SIDED|95.0|-0.54|0.26|||ANCOVA|||||0.26|-0.54|0.4893
91619616|NCT03238235|183131887|SUPERIORITY||Log Difference of Least Square Means|-0.34||||0.1498|TWO_SIDED|95.0|-0.81|0.13||This model was performed considering baseline biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||||0.13|-0.81|0.1498
91619617|NCT03238235|183131888|SUPERIORITY||Log Difference of Least Square Means|0.06||||0.0602|TWO_SIDED|95.0|0.0|0.13||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Standing and transfers (D1) at Visit 11||0.13|-0.00|0.0602
91619618|NCT03238235|183131888|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.5906|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Axial and proximal motor function (D2) at Visit 11||0.01|-0.01|0.5906
91619619|NCT03238235|183131888|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.7799|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Distal motor function (D3) at Visit 11||0.01|-0.01|0.7799
91619620|NCT03238235|183131888|SUPERIORITY||Log Difference of Least Square Means|0.01||||0.1116|TWO_SIDED|95.0|0.0|0.03||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Total Score at Visit 11||0.03|-0.00|0.1116
91619621|NCT03238235|183131889|SUPERIORITY||Log Difference of Least Square Means|-0.07||||0.4346|TWO_SIDED|95.0|-0.23|0.1||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Time to Walk/Run 10 meters at Visit 11||0.10|-0.23|0.4346
91524672|NCT01559454|182924458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||1|TWO_SIDED|95.0|0.0713|1.8248|||Fisher Exact|||||1.8248|0.0713|1.00
91619622|NCT03238235|183131890|SUPERIORITY||Log Difference of Least Square Means|-0.02||||0.8914|TWO_SIDED|95.0|-0.32|0.28|||Mixed Models Analysis|||Time to climb 4 standard steps (sec) at visit 11||0.28|-0.32|0.8914
91791671|NCT01931670|183461140|SUPERIORITY||Odds Ratio (OR)|10.106|||<|0.001|TWO_SIDED|97.5|6.434|15.874|||Regression, Logistic|||Month 6||15.874|6.434|< 0.001
91791672|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|1.191||||0.376|TWO_SIDED|97.5|0.765|1.855|||Regression, Logistic|||Month 1||1.855|0.765|0.376
91791673|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|1.376||||0.101|TWO_SIDED|97.5|0.89|2.127|||Regression, Logistic|||Month 1||2.127|0.890|0.101
91791674|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|1.358||||0.088|TWO_SIDED|97.5|0.909|2.029|||Regression, Logistic|||Month 2||2.029|0.909|0.088
91791675|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|2.208|||<|0.001|TWO_SIDED|97.5|1.488|3.278|||Regression, Logistic|||Month 2||3.278|1.488|< 0.001
91791676|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|1.678||||0.003|TWO_SIDED|97.5|1.136|2.477|||Regression, Logistic|||Month 4||2.477|1.136|0.003
91791677|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|2.722|||<|0.001|TWO_SIDED|97.5|1.832|4.044|||Regression, Logistic|||Month 4||4.044|1.832|< 0.001
91791678|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|1.537||||0.013|TWO_SIDED|97.5|1.042|2.267|||Regression, Logistic|||Month 5||2.267|1.042|0.013
91791679|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|2.598|||<|0.001|TWO_SIDED|97.5|1.75|3.857|||Regression, Logistic|||Month 5||3.857|1.750|< 0.001
91791680|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|1.565||||0.01|TWO_SIDED|97.5|1.062|2.306|||Regression, Logistic|||Month 6||2.306|1.062|0.01
91791681|NCT01931670|183461141|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|97.5|1.63|3.57|||Regression, Logistic|||Month 6||3.570|1.630|< 0.001
91524673|NCT01559454|182924459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.55075||||0.348|TWO_SIDED|95.0|-20.37051|51.34968|||t-test, 2 sided|||||51.34968|-20.37051|0.348
91524674|NCT01559454|182924460|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.5833||||0.088|TWO_SIDED|95.0|-7.9653|87.132|||t-test, 2 sided|||||87.1320|-7.9653|0.088
91658884|NCT02549092|183211929|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.47||0.93|TWO_SIDED|95.0|-0.99|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Radicular pain score||0.90|-0.99|0.930
91658885|NCT02549092|183211930|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.89|-1.87||ANCOVA model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|||-1.87|-2.89|< 0.001
91658886|NCT00910663|183211931|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.01||||||90.0|90.01|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|90.01|
91524675|NCT01559454|182924461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1499||||0.895|TWO_SIDED|95.0|-30.3965|27.0632|||t-test, 2 sided|||||27.0632|-30.3965|0.895
91524676|NCT01559454|182924462|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.6999|TWO_SIDED|95.0|0.127|2.8352|||Fisher Exact|||||2.8352|0.127|0.6999
91524677|NCT00431184|182924463|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mixed Models Analysis|||||||0.22
91658887|NCT00910663|183211932|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.81||||||90.0|100.23|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.45|100.23|
91791682|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.028||||0.901|TWO_SIDED|97.5|0.624|1.693|||Regression, Logistic|||Month 1||1.693|0.624|0.901
91524678|NCT00431184|182924464|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
91524679|NCT00462670|182924467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.58|-0.6|||t-test, 2 sided|||||-0.60|-1.58|<0.0001
91524680|NCT00462670|182924468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001|TWO_SIDED|95.0|-2.54|-0.92|||t-test, 2 sided|||||-0.92|-2.54|<0.0001
91524681|NCT00548132|182924469|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|0.24|0.9|||Cochran-Mantel-Haenszel|This was calculated based on the assumption that only 85% of eligible patients will consent to the study.|The standard of care is the numerator and the intervention group is the denominator|The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.||0.90|0.24|0.05
91658888|NCT00910663|183211933|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.35||||||90.0|100.51|106.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.27|100.51|
91658889|NCT01376167|183211939|SUPERIORITY||Hazard Ratio (HR)|0.299|||<|0.001|TWO_SIDED|95.0|0.222|0.404||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.404|0.222|<0.001
91658890|NCT01376167|183211939|SUPERIORITY||Hazard Ratio (HR)|0.262|||<|0.001|TWO_SIDED|95.0|0.178|0.387||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.387|0.178|<0.001
91791683|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.103||||0.65|TWO_SIDED|97.5|0.68|1.789|||Regression, Logistic|||Month 1||1.789|0.680|0.65
91791684|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.351||||0.154|TWO_SIDED|97.5|0.841|2.17|||Regression, Logistic|||Month 2||2.170|0.841|0.154
91791685|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.871||||0.003|TWO_SIDED|97.5|1.175|2.979|||Regression, Logistic|||Month 2||2.979|1.175|0.003
91791686|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.25||||0.294|TWO_SIDED|97.5|0.776|2.013|||Regression, Logistic|||Month 3||2.013|0.776|0.294
91791687|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.865||||0.003|TWO_SIDED|97.5|1.163|2.989|||Regression, Logistic|||Month 3||2.989|1.163|0.003
91791688|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.145||||0.521|TWO_SIDED|97.5|0.713|1.839|||Regression, Logistic|||Month 4||1.839|0.713|0.521
91791689|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|2.474|||<|0.001|TWO_SIDED|97.5|1.544|3.963|||Regression, Logistic|||Month 4||3.963|1.544|< 0.001
91791690|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.262||||0.27|TWO_SIDED|97.5|0.787|2.023|||Regression, Logistic|||Month 5||2.023|0.787|0.27
91791691|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|2.416|||<|0.001|TWO_SIDED|97.5|1.5|3.891|||Regression, Logistic|||Month 5||3.891|1.500|< 0.001
91791692|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.013||||0.953|TWO_SIDED|97.5|0.631|1.624|||Regression, Logistic|||Month 6||1.624|0.631|0.953
91791693|NCT01931670|183461142|SUPERIORITY||Odds Ratio (OR)|1.997|||<|0.001|TWO_SIDED|97.5|1.253|3.183|||Regression, Logistic|||Month 6||3.183|1.253|< 0.001
91791694|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.69|-0.37|||mixed-effects model|||Month 1||-0.37|-0.69|< 0.001
91791695|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.94|-0.62|||mixed-effects model|||Month 1||-0.62|-0.94|< 0.001
91791696|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.6|-0.29|||mixed-effects model|||Month 2||-0.29|-0.6|< 0.001
91791697|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.43|-1.12|||mixed-effects model|||Month 2||-1.12|-1.43|< 0.001
91791698|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.68|-0.37|||mixed-effects model|||Month 3||-0.37|-0.68|< 0.001
91658891|NCT01376167|183211939|SUPERIORITY||Odds Ratio (OR)|0.241|||<|0.001|TWO_SIDED|95.0|0.152|0.382||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.382|0.152|<0.001
91658892|NCT01376167|183211939|SUPERIORITY||Odds Ratio (OR)|0.198|||<|0.001|TWO_SIDED|95.0|0.117|0.335||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.335|0.117|<0.001
91658893|NCT01376167|183211940|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.001|TWO_SIDED|95.0|0.195|0.376||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.376|0.195|<0.001
91524682|NCT01187914|182924471|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.48||95.0|||||Regression, Linear|||||||0.48
91524683|NCT02150837|182924499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.||||||<0.0001
91658894|NCT01376167|183211940|SUPERIORITY||Hazard Ratio (HR)|0.255|||<|0.001|TWO_SIDED|95.0|0.167|0.39||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.390|0.167|<0.001
91658895|NCT02193165|183211966|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p\<0.5||||0.434
91658896|NCT02193165|183211967|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P\<0.05||||<0.001
91658897|NCT02193165|183211968|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P\<0.05||||<0.001
91658898|NCT02193165|183211969|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P\<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different||||0.816
91658899|NCT02193165|183211970|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
91524684|NCT02424591|182924631|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
91524685|NCT02424591|182924632|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91524686|NCT02424591|182924633|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91658900|NCT02193165|183211971|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
91658901|NCT01546545|183211982|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was the first pilot and feasibility study. This data will be used to power future studies.||||||0.02|||||||t-test, 2 sided|||||||0.02
91658902|NCT01546545|183211983|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was a pilot and feasibility study.||||||0.02|||||||t-test, 2 sided|||||||0.02
91658903|NCT01214850|183211984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.3828|TWO_SIDED|95.0|0.809|1.737|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination||1.737|0.809|0.3828
91658904|NCT01214850|183211985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.555|1.273|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine||1.273|0.555|
91658905|NCT03221374|183212031|OTHER|Linear mixed effect model to test the overall BCI learning between MBSR and control groups||||||0.003||||||The threshold for statistical analysis was p = 0.05.|Mixed Models Analysis|||||||0.003
91658906|NCT03221374|183212031|EQUIVALENCE|This independent t-test will test if the two groups (MBSR, control) exhibit a statistically significant difference in terms of BCI performance from baseline.|Mean Difference (Net)|8.98||||0.024|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided||The difference between BCI performance improvement in MBSR cohort and control cohort.|||||0.024
91658907|NCT03221374|183212032|EQUIVALENCE|This WRS test will determine if the MBSR group breath counting accuracy was significantly greater than the postintervention levels of controls.|Mean Difference (Net)|15.4|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91658908|NCT03221374|183212033|EQUIVALENCE|The null hypothesis is that the FMI scores of the two groups have equal medians.|Mean Difference (Final Values)|7.9|||<|0.01|TWO_SIDED|||||significant if p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
91658909|NCT03221374|183212033|EQUIVALENCE|The null hypothesis is that the MAAS scores of the two groups have equal medians.|Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91658910|NCT03221374|183212033|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the FMI score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.42|||<|0.05|TWO_SIDED|||||significant if p\<0.05|Regression, Linear|||||||<0.05
91658911|NCT03221374|183212033|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the MAAS score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.41|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
91658912|NCT03693430|183212053|SUPERIORITY|Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.|Treatment difference|-12.55|||<|0.0001|TWO_SIDED|95.0|-15.33|-9.77|||ANCOVA|||Treatment policy estimand||-9.77|-15.33|<.0001
91658913|NCT03693430|183212053|SUPERIORITY|All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.|Treatment difference|-16.05|||<|0.0001|TWO_SIDED|95.0|-18.64|-13.45|||MMRM (Mixed model repeated measurement)|||Hypothetical estimand||-13.45|-18.64|<0.0001
91658914|NCT03693430|183212054|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.95|8.42|||Regression, Logistic|||Treatment policy estimand||8.42|2.95|<0.0001
91658915|NCT03693430|183212054|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|10.04|32.49|||MMRM|||Hypothetical estimand||32.49|10.04|<0.0001
91658916|NCT02373098|183212094|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CCL5=RANTES||||0.000
91658917|NCT02373098|183212094|OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||IL17A||||0.035
91658918|NCT02373098|183212094|OTHER|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||CXCL13||||0.911
91658919|NCT02373098|183212094|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||IL6||||1.000
91658920|NCT02373098|183212094|OTHER|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||IL8||||0.934
91658921|NCT02373098|183212094|OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||IL13||||0.727
91658922|NCT02373098|183212094|OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||IL23||||0.179
91658923|NCT02373098|183212094|OTHER|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||VLA4||||0.208
91658924|NCT02373098|183212094|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||CXCL10=IP-10 (CXCR3 ligand)||||0.730
91658925|NCT02373098|183212094|OTHER|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||CCL2=MCP-1||||0.725
91658926|NCT02373098|183212094|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||IL4||||0.057
91658927|NCT02373098|183212094|OTHER|||||||0.724|||||||Wilcoxon (Mann-Whitney)|||TNF alpha||||0.724
91658928|NCT02373098|183212094|OTHER|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||IL22||||0.662
91658929|NCT02373098|183212095|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||CD3 abs||||0.256
91658930|NCT02373098|183212095|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||CD19 abs||||0.587
91658931|NCT02373098|183212095|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||NK abs||||0.300
91658932|NCT02373098|183212095|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||NKT abs||||0.096
91658933|NCT02373098|183212095|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 abs||||0.270
91658934|NCT02373098|183212095|OTHER|||||||0.902|||||||Wilcoxon (Mann-Whitney)|||CD4CD25||||0.902
91658935|NCT02373098|183212095|OTHER|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||Hi CD4CD25||||0.283
91658936|NCT02373098|183212098|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD3 %||||0.017
91658937|NCT02373098|183212098|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||CD19 %||||0.300
91658938|NCT02373098|183212098|OTHER|||||||0.657|||||||Wilcoxon (Mann-Whitney)|||NK %||||0.657
91658939|NCT02373098|183212098|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||NKT %||||0.439
91658940|NCT02373098|183212098|OTHER|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 %||||0.449
91658941|NCT02373098|183212098|OTHER|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.356
91658942|NCT02373098|183212098|OTHER|||||||0.787|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.787
91658943|NCT02373098|183212098|OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.121
91658944|NCT02373098|183212098|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.209
91658945|NCT02373098|183212098|OTHER|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||CD4+IFNg+ (in CD4+)||||0.069
91658946|NCT02373098|183212098|OTHER|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||CD4+IL17+ (in CD4+)||||0.402
91658947|NCT02373098|183212098|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IFNg+ (in CD8+)||||0.017
91658948|NCT02373098|183212098|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IL17+ (in CD8+)||||0.017
91658949|NCT02373098|183212098|OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||IFNg+ (in CD4+CD25+)||||0.026
91658950|NCT02373098|183212098|OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||IL17+ (in CD4+CD25+)||||0.168
91658951|NCT02373098|183212098|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||CD4+IL10+ (in CD4+)||||0.004
91658952|NCT02373098|183212098|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD4+IL4+ (in CD4+)||||0.013
91658953|NCT02373098|183212098|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||CD4-CD8-IL4+ (in CD4-CD8-)||||0.171
91658954|NCT02373098|183212098|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL10+ (in CD8+)||||0.013
91658955|NCT02373098|183212098|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL4+ (in CD8+)||||0.013
91658956|NCT02373098|183212098|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||IL10+ (in CD4+CD25+)||||0.007
91658957|NCT02373098|183212098|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||IL4+ (in CD4+CD25+)||||0.001
91658958|NCT02373098|183212098|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||CD4+TNFa+ (in CD4+)||||0.002
91658959|NCT02373098|183212098|OTHER|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||CD4+IL9+ (in CD4+)||||0.107
91658960|NCT02373098|183212098|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CD8+TNFa+ (in CD8+)||||0.000
91658961|NCT02373098|183212098|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||CD8+IL9+ (in CD8+)||||0.022
91658962|NCT02373098|183212098|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||TNFa+ (in CD4+CD25+)||||0.001
91658963|NCT02373098|183212098|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||IL9+ (in CD4+CD25+)||||0.127
91658964|NCT00855738|183212122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||<0.0001
91658965|NCT00855738|183212122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
91658966|NCT00855738|183212123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=25% reduction: p-value versus baseline.||||<0.0001
91658967|NCT00855738|183212123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=75% reduction: p-value versus baseline.||||<0.0001
91658968|NCT00855738|183212123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=25% reduction: p-value versus baseline.||||<0.0001
91658969|NCT00855738|183212123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=75% reduction: p-value versus baseline.||||<0.0001
91658970|NCT00855738|183212124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0039|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||0.0039
91658971|NCT00855738|183212124|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
91658972|NCT00855738|183212125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91658973|NCT00855738|183212136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1797|TWO_SIDED||||||t-test, 2 sided|||Depression domain: P-value vs baseline.||||0.1797
91658974|NCT00855738|183212136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0433|TWO_SIDED||||||t-test, 2 sided|||Anxiety domain: P-value vs baseline.||||0.0433
91658975|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8284|TWO_SIDED||||||t-test, 2 sided|||Energy: p-value versus baseline.||||0.8284
91658976|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6299|TWO_SIDED||||||t-test, 2 sided|||Emotions (mood): p-value versus baseline.||||0.6299
91658977|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6162|TWO_SIDED||||||t-test, 2 sided|||Daily activities: p-value versus baseline.||||0.6162
91658978|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||t-test, 2 sided|||Mental function: p-value versus baseline.||||0.5609
91658979|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4635|TWO_SIDED||||||t-test, 2 sided|||Medication effects (physical/ mental): p-value versus baseline.||||0.4635
91658980|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Worry about seizures (impact of seizures): p-value versus baseline.||||<0.0001
91658981|NCT00855738|183212137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0258|TWO_SIDED||||||t-test, 2 sided|||Overall quality of life: p-value versus baseline.||||0.0258
91658982|NCT00855738|183212138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7822|TWO_SIDED||||||t-test, 2 sided|||Month 3: p-value versus baseline.||||0.7822
91658983|NCT00855738|183212138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||t-test, 2 sided|||Month 6: p-value versus baseline.||||0.4471
91658984|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2452|TWO_SIDED||||||t-test, 2 sided|||Sleep disturbance: p-value versus baseline.||||0.2452
91658985|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Snoring: p-value verus baseline.||||1.0000
91658986|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4253|TWO_SIDED||||||t-test, 2 sided|||Awake short of breath: p-value versus baseline.||||0.4253
91658987|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0572|TWO_SIDED||||||t-test, 2 sided|||Quantity: p-value versus baseline.||||0.0572
91658988|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0625|TWO_SIDED||||||t-test, 2 sided|||Adequacy: p-value versus baseline.||||0.0625
91658989|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554|TWO_SIDED||||||t-test, 2 sided|||Somnolence: p-value versus baseline.||||0.5540
91658990|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4204|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 6): p-value versus baseline.||||0.4204
91658991|NCT00855738|183212139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 9): p-value versus baseline.||||0.4869
91658992|NCT00855738|183212140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0863|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||0.0863
91658993|NCT00855738|183212141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0226|TWO_SIDED||||||t-test, 2 sided|||Number of visits to a specialist because of epilepsy: p-value versus baseline.||||0.0226
91658994|NCT00855738|183212141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||t-test, 2 sided|||Number of visits to the emergency room because of epilepsy: p-value versus baseline.||||0.0017
91658995|NCT00855738|183212142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3141|TWO_SIDED||||||t-test, 2 sided|||P-value versus baseline.||||0.3141
91658996|NCT00855738|183212143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0708|TWO_SIDED||||||t-test, 2 sided|||Cessation of usual occupation: p-value versus baseline.||||0.0708
91658997|NCT00855738|183212143|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Requirement of informal caregiver: p-value versus baseline.||||1.0000
91658998|NCT00855738|183212143|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Required admission to ICU: p-value versus baseline.||||1.0000
91658999|NCT03966365|183212155|OTHER|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||||||0.706
91659000|NCT03966365|183212156|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
91659001|NCT03966365|183212157|OTHER|||||||0.081|||||||Chi-squared, Corrected|||Green lissamine treatment groups||||0.081
91659002|NCT03966365|183212157|OTHER|||||||0.49|||||||Chi-squared, Corrected|||Fluorescein treatment groups||||0.490
91659003|NCT03966365|183212158|OTHER|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
91659004|NCT03966365|183212159|OTHER|||||||0.031|||||||Chi-squared, Corrected|||||||0.031
91524687|NCT00988221|182924656|SUPERIORITY_OR_OTHER||Adjusted mean - Placebo|-22.3||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
91659005|NCT03966365|183212161|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||||||0.651
91659006|NCT01149473|183212184|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.0|||||TWO_SIDED|90.0|98.1|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120|98.1|
91659007|NCT01149473|183212185|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.0|||||TWO_SIDED|90.0|98.8|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106|98.8|
91713067|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.86|<0.001
91659008|NCT01149473|183212186|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.0|||||TWO_SIDED|90.0|98.6|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104|98.6|
91791699|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-1.4|-1.09|||mixed-effects model|||Month 3||-1.09|-1.4|< 0.001
91659009|NCT01149473|183212187|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|98.8|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108|98.8|
91659010|NCT01149473|183212188|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|95.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.6|
91659011|NCT01149473|183212189|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|98.7|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.7|
91659012|NCT00829530|183212234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.87||||||90.0|80.31|98.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.34|80.31|
91659013|NCT00829530|183212235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.96||||||90.0|89.77|100.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.45|89.77|
91791700|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.73|-0.42|||mixed-effects model|||Month 4||-0.42|-0.73|< 0.001
91713068|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3||1.12|0.82|<0.001
91713069|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.95|1.38||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2||1.38|0.95|<0.001
91659014|NCT00829530|183212236|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.24||||||90.0|90.13|100.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.63|90.13|
91659015|NCT00829530|183212237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.85||||||90.0|91.95|106.27|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.27|91.95|
91659016|NCT00829530|183212238|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.62||||||90.0|97.8|103.52|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.52|97.8|
91659017|NCT00840866|183212239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.0|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|99|
91659018|NCT00840866|183212240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.9||||||90.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.6|
91659019|NCT00840866|183212241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|98.5|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.5|
91713070|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.97|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3||1.42|0.97|<0.001
91713071|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.85|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3||1.23|0.85|<0.001
91659020|NCT04638153|183212247|OTHER||least square mean difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Month 3|Results based on Mixed-Effect Repeated Measures (MMRM) analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-0.2|
91659021|NCT04638153|183212247|OTHER||Least square mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.9|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.9|0.1|
91659022|NCT04638153|183212247|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.7|
91659023|NCT04638153|183212247|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
91791701|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-1.42|-1.11|||mixed-effects model|||Month 4||-1.11|-1.42|< 0.001
91524688|NCT00988221|182924656|SUPERIORITY_OR_OTHER||Adjusted mean - Tocilizumab|-32.4||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
91659024|NCT04638153|183212247|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
91659025|NCT04638153|183212247|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
91713072|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.84|<0.001
91713073|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3||1.11|0.84|<0.001
91659026|NCT04638153|183212247|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
91659027|NCT04638153|183212247|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
91659028|NCT04638153|183212247|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
91659029|NCT04638153|183212247|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
91659030|NCT04638153|183212247|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.3|-0.2|
91659031|NCT04638153|183212247|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
91659032|NCT04638153|183212257|OTHER||Least square mean difference|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.2|-0.5|
91659033|NCT04638153|183212257|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|0.2|1.8|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.8|0.2|
91659034|NCT04638153|183212257|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-1.5|
91659035|NCT04638153|183212257|OTHER||Least square mean difference|-0.5|||||TWO_SIDED|95.0|-1.6|0.6|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-1.6|
91659036|NCT04638153|183212257|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-0.4|1.9|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.9|-0.4|
91659037|NCT04638153|183212257|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||-0.1|-2.3|
91713074|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3||1.15|0.87|<0.001
91524689|NCT00988221|182924656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0076|TWO_SIDED|95.0|-17.6|-2.7||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||-2.7|-17.6|0.0076
91659038|NCT04638153|183212257|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.8|0.7|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.7|-0.8|
91659039|NCT04638153|183212257|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-0.2|1.5|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-0.2|
91659040|NCT04638153|183212257|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-1.5|
91659041|NCT04638153|183212257|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-1.3|1.5|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-1.3|
91659042|NCT04638153|183212257|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.4|2.8|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||2.8|-1.4|
91791702|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.65|-0.33|||mixed-effects model|||Month 5||-0.33|-0.65|< 0.001
91659043|NCT04638153|183212257|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-2.6|1.4|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.4|-2.6|
91659044|NCT01389102|183212281|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91659045|NCT01389102|183212281|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||ANCOVA|||||||0.0099
91659046|NCT01389102|183212281|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||||||0.0004
91659047|NCT01389102|183212282|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91659048|NCT01389102|183212282|SUPERIORITY_OR_OTHER|||||||0.0406||95.0|||||ANCOVA|||||||0.0406
91659049|NCT01389102|183212282|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91659050|NCT00050778|183212283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24||||0.0006|TWO_SIDED|95.0|0.11|0.545||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.545|0.110|0.0006
91659051|NCT00050778|183212283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0021|TWO_SIDED|95.0|0.151|0.658||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.658|0.151|0.0021
91659052|NCT00050778|183212283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.152|0.515|||Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.515|0.152|<0.0001
91713075|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.85|<0.001
91791703|NCT01931670|183461143|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-1.42|-1.1|||mixed-effects model|||Month 5||-1.10|-1.42|< 0.001
91659053|NCT00050778|183212284|SUPERIORITY_OR_OTHER||Rate ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.552||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.552|0.196|<0.0001
91659054|NCT00050778|183212284|SUPERIORITY_OR_OTHER||Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.126|0.431||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.431|0.126|<0.0001
91659055|NCT00050778|183212284|SUPERIORITY_OR_OTHER||Rate ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.176|0.441|||Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.441|0.176|<0.0001
91659056|NCT00050778|183212285|SUPERIORITY_OR_OTHER||Treatment effect|62.64||||0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||0.0001
91659057|NCT00050778|183212285|SUPERIORITY_OR_OTHER||Treatment effect|76.71|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
91659058|NCT00050778|183212285|SUPERIORITY_OR_OTHER||Treatment effect|70.13|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
91659059|NCT00050778|183212286|SUPERIORITY_OR_OTHER|||||||0.0885|||||||ANCOVA|||Ranked analysis of covariance (ANCOVA) model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0885
91659060|NCT00050778|183212286|SUPERIORITY_OR_OTHER|||||||0.0195|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0195
91659061|NCT00050778|183212286|SUPERIORITY_OR_OTHER|||||||0.0215|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0215
91791704|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-25.31|STANDARD_ERROR_OF_MEAN|3.669|<|0.001|TWO_SIDED|97.5|-33.55|-17.07|||mixed-effects model|||Month 1||-17.07|-33.55|< 0.001
91791705|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-39.32|STANDARD_ERROR_OF_MEAN|3.657|<|0.001|TWO_SIDED|97.5|-47.53|-31.11|||mixed-effects model|||Month 1||-31.11|-47.53|< 0.001
91791706|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-21.9|STANDARD_ERROR_OF_MEAN|3.355|<|0.001|TWO_SIDED|97.5|-29.44|-14.36|||mixed-effects model|||Month 2||-14.36|-29.44|< 0.001
91791707|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-63.31|STANDARD_ERROR_OF_MEAN|3.365|<|0.001|TWO_SIDED|97.5|-70.87|-55.76|||mixed-effects model|||Month 2||-55.76|-70.87|< 0.001
91659062|NCT00050778|183212287|SUPERIORITY_OR_OTHER|||||||0.3077|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3077
91659063|NCT00050778|183212287|SUPERIORITY_OR_OTHER|||||||0.3632|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3632
91659064|NCT00050778|183212287|SUPERIORITY_OR_OTHER|||||||0.2758|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.2758
91659065|NCT02728102|183212405|SUPERIORITY||difference in the proportions|2.9||||0.3657|TWO_SIDED|80.0|-8.8|14.6||A one-sided significance level of 0.10 is used to assess whether the vaccine appears promising relative to control.|Z test|||The proportion of patients alive and in CR/sCR at 1 year post transplant will be described in the vaccine and no vaccine groups with 80% confidence intervals and compared between groups using a two-sample Z test comparing binomial proportions.||14.6|-8.8|0.3657
91659066|NCT02728102|183212405|EQUIVALENCE|The stratified odds ratio is estimated with 80% confidence intervals.|Odds Ratio (OR)|1.19||||0.7461|TWO_SIDED|80.0|0.7|2.03||P-value is provided by Breslow-Day Test for Homogeneity of the Odds Ratios.|Cochran-Mantel-Haenszel||The Cochran-Mantel-Haenszel Odds Ratio estimate is for the Stratification. Stratum 1 is sCR/CR at Randomization. Stratum 2 is VGPR/PR/Stable Response at Randomization.|A secondary analysis stratified on disease response prior to randomization between arms will be conducted using a Cochran-Mantel-Haenszel test, and a stratified odds ratio along with 80% confidence intervals will be estimated.||2.03|0.70|0.7461
91659067|NCT02728102|183212405|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide/GM-CSF arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|7.2||||0.2429|TWO_SIDED|80.0|-6.4|20.6|||Z test|||A secondary pairwise analysis of CR/sCR rates comparing the vaccine arm to Lenalidomide/GM-CSF arm at 1 year post transplant.||20.6|-6.4|0.2429
91659068|NCT02728102|183212405|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide alone arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|-1.6||||0.4397|TWO_SIDED|80.0|-15.6|12.4|||Z test|||A secondary pairwise analysis of CR rates comparing the vaccine arm to Lenalidomide alone arm at 1 year post transplant.||12.4|-15.6|0.4397
91659069|NCT02728102|183212406|SUPERIORITY|||||||0.9376||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.9376
91659070|NCT02728102|183212406|SUPERIORITY|||||||0.4887||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.||||0.4887
91659071|NCT02728102|183212406|SUPERIORITY|||||||0.5176||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.||||0.5176
91659072|NCT02728102|183212406|SUPERIORITY|||||||0.2461||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.||||0.2461
91713076|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
91659073|NCT02728102|183212406|SUPERIORITY|||||||0.253||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.||||0.2530
91659074|NCT02728102|183212406|SUPERIORITY|||||||0.2213||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.||||0.2213
91659075|NCT02728102|183212406|SUPERIORITY|||||||0.493||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.||||0.4930
91659076|NCT02728102|183212406|SUPERIORITY|||||||0.6591||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.||||0.6591
91659077|NCT02728102|183212406|SUPERIORITY|||||||0.679||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.||||0.6790
91659078|NCT02728102|183212406|SUPERIORITY|||||||0.3124||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.||||0.3124
91659079|NCT02728102|183212406|SUPERIORITY|||||||0.7379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.||||0.7379
91659080|NCT02728102|183212406|SUPERIORITY|||||||0.2379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.||||0.2379
91659081|NCT02728102|183212406|SUPERIORITY|||||||0.5353||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.5353
91659082|NCT02728102|183212406|SUPERIORITY|||||||0.4417||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 12 months Post Transplant.||||0.4417
91659083|NCT02728102|183212406|SUPERIORITY|||||||0.945||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 24 months Post Transplant.||||0.9450
91659084|NCT02728102|183212406|SUPERIORITY|||||||0.1599||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide/GM-CSF arm is conducted at 1 year post transplant.||||0.1599
91713077|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.92|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.92|<0.001
91713078|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.91|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2||1.15|0.91|<0.001
91713079|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3||1.07|0.84|<0.001
91713080|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.82|1.04||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3||1.04|0.82|<0.001
91713081|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2||1.14|0.84|<0.001
91713082|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.92|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3||1.24|0.92|<0.001
91791708|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-25.15|STANDARD_ERROR_OF_MEAN|3.241|<|0.001|TWO_SIDED|97.5|-32.43|-17.88|||mixed-effects model|||Month 3||-17.88|-32.43|< 0.001
91524690|NCT00988221|182924657|SUPERIORITY_OR_OTHER||Weighted difference|18.0||||1|TWO_SIDED|95.0|5.0|32.0||1.000 is used here as the test was considered as not significant due to the break in the hierarchical testing chain.|Cochran-Mantel-Haenszel|The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||The analysis used the Cochran-Mantel-Haenszel test adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||32|5|1.000
91791709|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-61.94|STANDARD_ERROR_OF_MEAN|3.233|<|0.001|TWO_SIDED|97.5|-69.2|-54.68|||mixed-effects model|||Month 3||-54.68|-69.20|< 0.001
91791710|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-26.97|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|97.5|-34.48|-19.46|||mixed-effects model|||Month 4||-19.46|-34.48|< 0.001
91791711|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-62.37|STANDARD_ERROR_OF_MEAN|3.346|<|0.001|TWO_SIDED|97.5|-69.89|-54.86|||mixed-effects model|||Month 4||-54.86|-69.89|< 0.001
91791712|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-23.36|STANDARD_ERROR_OF_MEAN|3.428|<|0.001|TWO_SIDED|97.5|-31.06|-15.66|||mixed-effects model|||Month 5||-15.66|-31.06|< 0.001
91659085|NCT02728102|183212406|SUPERIORITY|||||||0.8984||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.8984
91659086|NCT02728102|183212406|SUPERIORITY|||||||0.1757||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between lenalidomide/GM-CSF arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.1757
91659087|NCT02728102|183212407|SUPERIORITY|||||||0.161||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between vaccine vs. non- vaccine arms.||||0.161
91659088|NCT02728102|183212408|SUPERIORITY|||||||0.116||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide/GM-CSF arm.||||0.116
91659089|NCT02728102|183212408|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide alone arm.||||0.519
91713083|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.27||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3||1.27|0.94|<0.001
91713084|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.93|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2||1.29|0.93|<0.001
91713085|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.87|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3||1.21|0.87|<0.001
91713086|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3||1.10|0.80|<0.001
91713087|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cDLA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.85|<0.001
91713088|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.86|<0.001
91713089|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3||1.19|0.87|<0.001
91713090|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.0|1.48||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2||1.48|1.00|<0.001
91659090|NCT02728102|183212408|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
91713091|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.8|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.80|<0.001
91659091|NCT02728102|183212410|SUPERIORITY|||||||0.168||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between vaccine vs. non- vaccine arms.||||0.168
91659092|NCT02728102|183212411|SUPERIORITY|||||||0.12||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.120
91659093|NCT02728102|183212411|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide alone arm.||||0.519
91713092|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.66|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3||0.97|0.66|<0.001
91713093|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2||1.18|0.88|<0.001
91713094|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.88|<0.001
91659094|NCT02728102|183212411|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
91659095|NCT02728102|183212412|SUPERIORITY|||||||0.563||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between vaccine vs. non- vaccine arms.||||0.563
91659096|NCT02728102|183212413|SUPERIORITY|||||||0.308||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.308
91713095|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.87|<0.001
91713096|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2||1.20|0.87|<0.001
91713097|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3||1.20|0.87|<0.001
91713098|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3||1.17|0.85|<0.001
91713099|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|0.93|1.33||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2||1.33|0.93|<0.001
91713100|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3||1.29|0.90|<0.001
91713101|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.81|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.81|<0.001
91659097|NCT02728102|183212413|SUPERIORITY|||||||0.99||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide alone arm.||||0.990
91791713|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-62.9|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|97.5|-70.58|-55.22|||mixed-effects model|||Month 5||-55.22|-70.58|< 0.001
91659098|NCT02728102|183212413|SUPERIORITY|||||||0.303||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.303
91659099|NCT02728102|183212415|SUPERIORITY|||||||0.189||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients With Grade ≥ 3 Toxicities between vaccine vs. non- vaccine arms.||||0.189
91659100|NCT02728102|183212417|SUPERIORITY|||||||0.82||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between vaccine vs. non- vaccine arms.||||0.82
91659101|NCT02728102|183212418|SUPERIORITY|||||||0.21||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide/GM-CSF arm.||||0.21
91659102|NCT02728102|183212418|SUPERIORITY|||||||0.4||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide alone arm.||||0.40
91659103|NCT02728102|183212418|SUPERIORITY|||||||0.08||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.08
91659104|NCT02728102|183212419|SUPERIORITY|||||||0.8||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients without Minimal Residual Disease between vaccine vs. non- vaccine arms||||0.80
91659105|NCT03834870|183212428|OTHER||Percentage of enrolled from eligible|84.05|||||TWO_SIDED|95.0|81.98|86.1||||||||86.10|81.98|
91659106|NCT03834870|183212429|OTHER||Percentage of enrolled from eligible|99.01|||||TWO_SIDED|95.0|98.4|99.6||||||||99.60|98.40|
91659107|NCT01544127|183212443|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.19||0.054|TWO_SIDED|95.0|0.31|1.12||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|"MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||1.12|0.31|.054
91659108|NCT01544127|183212443|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.12|TWO_SIDED|95.0|0.26|1.4||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI+TAU vs. TAU Alone||1.40|0.26|0.12
91659109|NCT01544127|183212443|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.22||0.08|TWO_SIDED|95.0|0.28|1.24||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI-R + TAU vs. TAU Alone||1.24|0.28|0.08
91659110|NCT01544127|183212444|SUPERIORITY||Beta|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.3|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||"MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||||0.30
91713102|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.91|<0.001
91659111|NCT01544127|183212444|SUPERIORITY||Beta|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI vs. TAU Alone||||0.23
91713103|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.91|<0.001
91791714|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-25.89|STANDARD_ERROR_OF_MEAN|3.528|<|0.001|TWO_SIDED|97.5|-33.81|-17.97|||mixed-effects model|||Month 6||-17.97|-33.81|< 0.001
91659112|NCT01544127|183212444|SUPERIORITY||Beta|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.46|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI-R vs. TAU Alone||||0.46
91659113|NCT01544127|183212445|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.65||0.96|TWO_SIDED|0.95|0.3|3.54||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI + TAU vs. TAU Alone||3.54|0.30|0.96
91791715|NCT01931670|183461144|SUPERIORITY||LS Mean of Difference|-56.62|STANDARD_ERROR_OF_MEAN|3.522|<|0.001|TWO_SIDED|97.5|-64.53|-48.7|||mixed-effects model|||Month 6||-48.70|-64.53|< 0.001
91659114|NCT01544127|183212445|SUPERIORITY||Odds Ratio (OR)|0.68|STANDARD_ERROR_OF_MEAN|0.38||0.5|TWO_SIDED|95.0|0.23|2.06||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI-R + TAU vs. TAU Alone||2.06|0.23|0.50
91659115|NCT01544127|183212446|SUPERIORITY||Cox Proportional Hazard|1.69|STANDARD_ERROR_OF_MEAN|0.91||0.31|TWO_SIDED|95.0|0.59|4.88||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI + TAU vs. TAU Alone||4.88|0.59|0.31
91791716|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.549|TWO_SIDED|97.5|-0.11|0.07|||mixed-effects model|||Month 1||0.07|-0.11|0.549
91791717|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.02
91791718|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.11|TWO_SIDED|97.5|-0.17|0.03|||mixed-effects model|||Month 2||0.03|-0.17|0.11
91791719|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|97.5|-0.3|-0.11|||mixed-effects model|||Month 2||-0.11|-0.30|< 0.001
91791720|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.041|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||Month 3||0.01|-0.22|0.041
91619623|NCT03238235|183131891|SUPERIORITY||Difference of Least Square Means|0.62||||0.7629|TWO_SIDED|95.0|-3.51|4.75||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Time to rise from floor at Visit 11||4.75|-3.51|0.7629
91619624|NCT03238235|183131892|SUPERIORITY||Log Difference of Least Square Means|-0.01||||0.8106|TWO_SIDED|95.0|-0.11|0.08||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Maximum distance walked after 6 minutes at Visit 11||0.08|-0.11|0.8106
91619625|NCT03238235|183131893|SUPERIORITY|||||||0.1626||||||P-value is obtained from the two-sided Cochran-Mantel-Haenszel chi-squared test, stratified for concomitant steroid use at baseline|Cochran-Mantel-Haenszel|||\<10% worsening at visit 11||||0.1626
91659116|NCT01544127|183212446|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.39||0.24|TWO_SIDED|95.0|0.1|2.31||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI-R vs. TAU Alone||2.31|0.10|0.24
91659117|NCT01544127|183212446|SUPERIORITY||Cox Proportional Hazard|0.29|STANDARD_ERROR_OF_MEAN|0.23||0.1|TWO_SIDED|95.0|0.06|1.43||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||"MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU."||1.43|0.06|0.10
91619626|NCT03238235|183131896|SUPERIORITY||Difference of Least Square Means|3.57||||0.5099|TWO_SIDED|95.0|-7.27|14.41||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Knee Extension (N) at Visit 11||14.41|-7.27|0.5099
91659118|NCT02996682|183212461|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
91659119|NCT02996682|183212461|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
91659120|NCT02605395|183212489|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.|Ratio of means|95.71|||||TWO_SIDED|90.0|90.12|101.65||||||||101.65|90.12|
91659121|NCT02605395|183212490|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.|Ratio of means|96.5|||||TWO_SIDED|90.0|90.02|103.44||||||||103.44|90.02|
91659122|NCT02605395|183212491|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.|Ratio of means|95.69|||||TWO_SIDED|90.0|87.06|105.17||||||||105.17|87.06|
91659123|NCT00696020|183212499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.027||0.3791|TWO_SIDED|95.0|-0.029|0.076||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.076|-0.029|0.3791
91659124|NCT00696020|183212499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.027||0.2133|TWO_SIDED|95.0|-0.019|0.085||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.085|-0.019|0.2133
91659125|NCT00696020|183212499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0337|TWO_SIDED|95.0|0.004|0.11||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.110|0.004|0.0337
91659126|NCT00696020|183212500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.026||0.1163|TWO_SIDED|95.0|-0.01|0.093||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.093|-0.010|0.1163
91791721|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||Month 3||-0.18|-0.41|< 0.001
91619627|NCT03238235|183131896|SUPERIORITY||Difference of Least Square Means|1.16||||0.7355|TWO_SIDED|95.0|-5.73|8.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Knee Extension (N) at Visit 11||8.06|-5.73|0.7355
91659127|NCT00696020|183212500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.026||0.0224|TWO_SIDED|95.0|0.009|0.111||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.111|0.009|0.0224
91659128|NCT00696020|183212500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.026||0.038|TWO_SIDED|95.0|0.003|0.107||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.107|0.003|0.0380
91659129|NCT00696020|183212501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.047||0.9573|TWO_SIDED|95.0|-0.089|0.094|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.094|-0.089|0.9573
91791722|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.052||0.081|TWO_SIDED|97.5|-0.21|0.03|||mixed-effects model|||Month 4||0.03|-0.21|0.081
91659130|NCT00696020|183212501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.046||0.0321|TWO_SIDED|95.0|0.009|0.189|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.009|0.0321
91659131|NCT00696020|183212501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.047||0.0125|TWO_SIDED|95.0|0.025|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.025|0.0125
91659132|NCT00696020|183212502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.03||0.0052|TWO_SIDED|95.0|0.026|0.145|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.145|0.026|0.0052
91659133|NCT00696020|183212502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.03||0.0086|TWO_SIDED|95.0|0.02|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|0.020|0.0086
91659134|NCT00696020|183212502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.066|0.185|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.185|0.066|<0.0001
91659135|NCT00696020|183212503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.056||0.0384|TWO_SIDED|95.0|0.006|0.225|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.225|0.006|0.0384
91659136|NCT00696020|183212503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.055||0.0009|TWO_SIDED|95.0|0.076|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.076|0.0009
91659137|NCT00696020|183212503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.13|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.130|<0.0001
91659138|NCT00696020|183212504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|6.76||0.001|TWO_SIDED|95.0|9.057|35.657|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.657|9.057|0.0010
91713104|NCT05464420|183317608|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3||1.14|0.89|<0.001
91659139|NCT00696020|183212504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.769|STANDARD_ERROR_OF_MEAN|6.687||0.0053|TWO_SIDED|95.0|5.613|31.924|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||31.924|5.613|0.0053
91713105|NCT05464420|183317609|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
91659140|NCT00696020|183212504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.954|STANDARD_ERROR_OF_MEAN|6.805|<|0.0001|TWO_SIDED|95.0|13.565|40.343|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||40.343|13.565|<0.0001
91713106|NCT05464420|183317609|OTHER||GMT Ratio|3.48|||||TWO_SIDED|95.0|3.01|4.02|||||V116 Combined Lots/PPSV23|Serotype 6A: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.02|3.01|
91524691|NCT03885011|182924688|SUPERIORITY||Odds Ratio (OR)|1.103||||0.8445|TWO_SIDED|95.0|0.413|2.949|||Regression, Logistic|||This analysis relates to Day 8 up to when pilocarpine HCl 0.2% either in CSF-1-FDC or as pilocarpine alone was administered for one week.||2.949|0.413|0.8445
91659141|NCT00696020|183212505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.0048|TWO_SIDED|95.0|0.027|0.149|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.149|0.027|0.0048
91659142|NCT00696020|183212505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.031||0.0056|TWO_SIDED|95.0|0.025|0.146|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.025|0.0056
91659143|NCT00696020|183212505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.066|0.189|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.066|<0.0001
91659144|NCT00696020|183212506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.0332|TWO_SIDED|95.0|0.01|0.23|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.230|0.010|0.0332
91659145|NCT00696020|183212506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.055||0.0011|TWO_SIDED|95.0|0.074|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.074|0.0011
91659146|NCT00696020|183212506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.128|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.128|<0.0001
91659147|NCT00696020|183212507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.867|STANDARD_ERROR_OF_MEAN|6.813||0.0009|TWO_SIDED|95.0|9.462|36.272|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||36.272|9.462|0.0009
91659148|NCT00696020|183212507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.743|STANDARD_ERROR_OF_MEAN|6.739||0.0036|TWO_SIDED|95.0|6.484|33.002|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||33.002|6.484|0.0036
91619628|NCT03238235|183131896|SUPERIORITY||Difference of Least Square Means|3.92||||0.6037|TWO_SIDED|95.0|-11.22|19.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Elbow Flexion (N) at Visit 11||19.06|-11.22|0.6037
91659149|NCT00696020|183212507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.793|STANDARD_ERROR_OF_MEAN|6.859|<|0.0001|TWO_SIDED|95.0|14.298|41.287|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||41.287|14.298|<0.0001
91659150|NCT00696020|183212508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.033||0.0079|TWO_SIDED|95.0|0.023|0.152|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.152|0.023|0.0079
91659151|NCT00696020|183212508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.032||0.012|TWO_SIDED|95.0|0.018|0.146|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.018|0.0120
91713107|NCT05464420|183317609|OTHER||GMT Ratio|1.33|||||TWO_SIDED|95.0|1.18|1.49|||||V116 Combined Lots/PPSV23|Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.49|1.18|
91713108|NCT05464420|183317609|OTHER||GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.93|||||V116 Combined Lots/PPSV23|Serotype 8: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.93|0.77|
91713109|NCT05464420|183317609|OTHER||GMT Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.08|||||V116 Combined Lots/PPSV23|Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.08|0.85|
91713110|NCT05464420|183317609|OTHER||GMT Ratio|1.32|||||TWO_SIDED|95.0|1.18|1.48|||||V116 Combined Lots/PPSV23|Serotype 10A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.48|1.18|
91713111|NCT05464420|183317609|OTHER||GMT Ratio|1.74|||||TWO_SIDED|95.0|1.56|1.95|||||V116 Combined Lots/PPSV23|Serotype 11A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.95|1.56|
91713112|NCT05464420|183317609|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||V116 Combined Lots/PPSV23|Serotype 12F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.56|1.22|
91713113|NCT05464420|183317609|OTHER||GMT Ratio|4.03|||||TWO_SIDED|95.0|3.56|4.56|||||V116 Combined Lots/PPSV23|Serotype 15A: GMT Ratio v116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.56|3.56|
91713114|NCT05464420|183317609|OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.49|3.38|||||V116 Combined Lots/PPSV23|Serotype 15C: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|3.38|2.49|
91713115|NCT05464420|183317609|OTHER||GMT Ratio|3.72|||||TWO_SIDED|95.0|3.32|4.17||||||Serotype 16F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.17|3.32|
91619629|NCT03238235|183131896|SUPERIORITY||Difference of Least Square Means|4.1||||0.6178|TWO_SIDED|95.0|-12.35|20.55||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Elbow Flexion (N) at Visit 11||20.55|-12.35|0.6178
91713116|NCT05464420|183317609|OTHER||GMT Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.91|||||V116 Combined Lots/PPSV23|Serotype 17F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.91|1.53|
91713117|NCT05464420|183317609|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 19A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
91713118|NCT05464420|183317609|OTHER||GMT Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.67|||||V116 Combined Lots/PPSV23|Serotype 20A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.67|1.30|
91713119|NCT05464420|183317609|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.17|1.53|||||V116 Combined Lots/PPSV23|Serotype 22F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.53|1.17|
91524692|NCT03885011|182924688|SUPERIORITY||Odds Ratio (OR)|1.646||||0.266|TWO_SIDED|95.0|0.684|3.958|||Regression, Logistic|||||3.958|0.684|0.2660
91659152|NCT00696020|183212508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.08|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.080|<0.0001
91659153|NCT00696020|183212509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.06||0.0296|TWO_SIDED|95.0|0.013|0.249|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.249|0.013|0.0296
91713120|NCT05464420|183317609|OTHER||GMT Ratio|7.98|||||TWO_SIDED|95.0|6.84|9.31|||||V116 Combined Lots/PPSV23|Serotype 23A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|9.31|6.84|
91713121|NCT05464420|183317609|OTHER||GMT Ratio|23.72|||||TWO_SIDED|95.0|19.71|28.55|||||V116 Combined Lots/PPSV23|Serotype 23B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|28.55|19.71|
91713122|NCT05464420|183317609|OTHER||GMT Ratio|19.55|||||TWO_SIDED|95.0|16.7|22.88|||||V116 Combined Lots/PPSV23|Serotype 24F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|22.88|16.70|
91659154|NCT00696020|183212509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|0.087|0.32|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.320|0.087|0.0007
91659155|NCT00696020|183212509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.147|0.383|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.383|0.147|<0.0001
91713123|NCT05464420|183317609|OTHER||GMT Ratio|13.55|||||TWO_SIDED|95.0|11.68|15.71|||||V116 Combined Lots/PPSV23|Serotype 31: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|15.71|11.68|
91659156|NCT00696020|183212510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.414|STANDARD_ERROR_OF_MEAN|7.057||0.001|TWO_SIDED|95.0|9.529|37.3|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||37.300|9.529|0.0010
91659157|NCT00696020|183212510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.695|STANDARD_ERROR_OF_MEAN|6.981||0.0078|TWO_SIDED|95.0|4.961|32.43|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||32.430|4.961|0.0078
91659158|NCT00696020|183212510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.357|STANDARD_ERROR_OF_MEAN|7.105|<|0.0001|TWO_SIDED|95.0|15.379|43.335|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||43.335|15.379|<0.0001
91659159|NCT00696020|183212512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.048||0.3517|TWO_SIDED|95.0|-0.049|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|-0.049|0.3517
91659160|NCT00696020|183212512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.048||0.3171|TWO_SIDED|95.0|-0.046|0.143|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.143|-0.046|0.3171
91659161|NCT00696020|183212512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.048||0.4654|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.130|-0.060|0.4654
91659162|NCT00696020|183212513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.106|STANDARD_ERROR_OF_MEAN|7.704||0.0899|TWO_SIDED|95.0|-2.055|28.267|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||28.267|-2.055|0.0899
91659163|NCT00696020|183212513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.817|STANDARD_ERROR_OF_MEAN|7.759||0.0111|TWO_SIDED|95.0|4.549|35.084|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.084|4.549|0.0111
91713124|NCT05464420|183317609|OTHER||GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 33F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.97|0.73|
91713125|NCT05464420|183317609|OTHER||GMT Ratio|3.71|||||TWO_SIDED|95.0|3.36|4.09|||||V116 Combined Lots/PPSV23|Serotype 35B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.09|3.36|
91713126|NCT05464420|183317610|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||V116 Lot 1/V116 Lot 2|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.09|0.88|
91713127|NCT05464420|183317610|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||||V116 Lot 1/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.85|
91524693|NCT03885011|182924689|SUPERIORITY||Odds Ratio (OR)|3.664||||0.0015|TWO_SIDED|95.0|1.646|8.154|||Regression, Logistic|||||8.154|1.646|0.0015
91524694|NCT03885011|182924689|SUPERIORITY||Odds Ratio (OR)|4.745||||0.0002|TWO_SIDED|95.0|2.088|10.786|||Regression, Logistic|||||10.786|2.088|0.0002
91524695|NCT03885011|182924690|SUPERIORITY|||||||0.1145|||||||Chi-squared|||||||0.1145
91524696|NCT03885011|182924690|SUPERIORITY|||||||0.0616|||||||Chi-squared|||||||0.0616
91659164|NCT00696020|183212513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.893|STANDARD_ERROR_OF_MEAN|7.844||0.0166|TWO_SIDED|95.0|3.458|34.329|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||34.329|3.458|0.0166
91659165|NCT02511782|183212535|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91659166|NCT02511782|183212536|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91659167|NCT02514122|183212544|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.29|1.9||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|t-test, 2 sided||Score was lower in the Ketamine group.|||1.9|0.29|0.009
91659168|NCT02514122|183212545|SUPERIORITY||Risk Difference (RD)|0.37|||<|0.001|TWO_SIDED|95.0|0.18|0.54|||Fisher Exact|||||.54|.18|<0.001
91659169|NCT01472341|183212559|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||0.24
91659170|NCT01472341|183212560|SUPERIORITY_OR_OTHER|||||||0.001|||||||Multivariate regression analysis|PI/I ratio was the response variable and other study parameters were independent variables.||||||0.001
91659171|NCT01472341|183212561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||<0.0001
91659172|NCT00678639|183212567|SUPERIORITY_OR_OTHER||Median cost difference|588.0|||||TWO_SIDED|95.0|336.0|811.0|||Hodges-Lehmann (median cost difference)|Distribution-free 95% CIs calculated using the method of Moses.|Results favored a reduced cost in the OU-CMR group.|H0: The median costs are not different among the study groups. HA: The median cost is different among groups. Power calculation was based on detecting a mean cost difference of $2000. Data was found to be non-normally distributed and therefore nonparametric comparisons were implemented.||811|336|
91659173|NCT00678639|183212568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||"H0: There is no difference in correct cardiovascular admission decisions among groups.~Ha: A difference exists among study groups. Sample size was based upon 47 analyzable participants per study arm were required to provide 88% power to detect a 30% difference in the outcome."||||<0.001
91619630|NCT03238235|183131899|SUPERIORITY||log difference of Least Square Means|-0.03||||0.1165|TWO_SIDED|95.0|-0.06|0.01||ANCOVA model was performed considering baseline fat fraction of lower limb muscles value as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Medial Thigh at visit 11||0.01|-0.06|0.1165
91619631|NCT03238235|183131900|SUPERIORITY||Log difference of Least Square Means|0.05||||0.1939|TWO_SIDED|95.0|-0.02|0.12||ANCOVA model was performed considering baseline CSA as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Hamstrings at Visit 11||0.12|-0.02|0.1939
91619632|NCT03238235|183131901|SUPERIORITY||Log difference of Least Square Means|0.01||||0.9493|TWO_SIDED|95.0|-0.29|0.3||ANCOVA model was performed considering baseline biopsy histological parameters (slide III) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||CSA Type I||0.30|-0.29|0.9493
91619633|NCT03238235|183131902|SUPERIORITY||Log difference of Least Square Means|0.05||||0.6265|TWO_SIDED|95.0|-0.16|0.26||ANCOVA model was performed considering baseline biopsy histological parameters (slide I) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Total number of Fibers at Visit 11 (slide I)||0.26|-0.16|0.6265
91619634|NCT03238235|183131902|SUPERIORITY||Log difference of Least Square Means|-0.44||||0.1562|TWO_SIDED|95.0|-1.05|0.17||ANCOVA model was performed considering baseline biopsy histological parameters (slide II) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Regenerative Fibers (%) at Visit 11||0.17|-1.05|0.1562
91619635|NCT01975935|183131906|SUPERIORITY|||||||0.05||||||This is the calculated p value and not the threshold for statistical significance.|t-test, 2 sided|||||||0.05
91619636|NCT01975935|183131907|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91619637|NCT01975935|183131908|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
91619638|NCT00243230|183131909|SUPERIORITY||VCV 30 mg vs. Placebo|-0.98||||0.0017|TWO_SIDED|95.0|-1.58|-0.37|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.37|-1.58|0.0017
91619639|NCT00243230|183131909|SUPERIORITY||VCV 20 mg vs. Placebo|-0.93||||0.0026||95.0|-1.54|-0.33|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.33|-1.54|0.0026
91619640|NCT00243230|183131910|SUPERIORITY|||||||0.0052|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0052
91619641|NCT00243230|183131910|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0190
91619642|NCT00243230|183131911|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0007
91713128|NCT05464420|183317610|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.87|1.08|||||V116 Lot 2/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.08|0.87|
91619643|NCT00243230|183131911|SUPERIORITY|||||||0.0028|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0028
91619644|NCT00243230|183131913|SUPERIORITY||Vicriviroc 30mg - Placebo|-1.0||||0.0002|TWO_SIDED|95.0|-1.53|-0.48|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.48|-1.53|0.0002
91619645|NCT00243230|183131913|SUPERIORITY||Vicriviroc 20 mg - Placebo|-0.84||||0.002|TWO_SIDED|95.0|-1.36|-0.31|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.31|-1.36|0.0020
91619646|NCT00243230|183131914|SUPERIORITY||Vicriviroc 30 mg - Placebo|-1.1||||0.0003|TWO_SIDED|95.0|-1.69|-0.51|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.51|-1.69|0.0003
91791723|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|97.5|-0.45|-0.22|||mixed-effects model|||Month 4||-0.22|-0.45|<0.001
91524697|NCT03885011|182924691|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
91619647|NCT00243230|183131914|SUPERIORITY||Vicriviroc 20 mg - Placebo|-1.07||||0.0004|TWO_SIDED|95.0|-1.66|-0.49|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.49|-1.66|0.0004
91619648|NCT00243230|183131915|SUPERIORITY||VCV 30 mg - Placebo|57.76||||0.0264|TWO_SIDED|95.0|6.9|108.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||108.61|6.90|0.0264
91619649|NCT00243230|183131915|SUPERIORITY||VCV 20 mg - Placebo|42.36||||0.102|TWO_SIDED|95.0|-8.55|93.28|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||93.28|-8.55|0.1020
91619650|NCT00243230|183131916|SUPERIORITY||VCV 30 mg - Placebo|38.12||||0.1525|TWO_SIDED|95.0|-14.32|90.56|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||90.56|-14.32|0.1525
91619651|NCT00243230|183131916|SUPERIORITY||VCV 20 mg - Placebo|44.12||||0.0987|TWO_SIDED|95.0|-8.38|96.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||96.61|-8.38|0.0987
91619652|NCT00243230|183131917|SUPERIORITY||VCV 30 mg - Placebo|37.32||||0.2603|TWO_SIDED|95.0|-28.05|102.68|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||102.68|-28.05|0.2603
91619653|NCT00243230|183131917|SUPERIORITY||VCV 20 mg - Placebo|69.08||||0.0387|TWO_SIDED|95.0|3.64|134.52|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||134.52|3.64|0.0387
91619654|NCT00243230|183131919|SUPERIORITY|||||||0.0031|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0031
91619655|NCT00243230|183131919|SUPERIORITY|||||||0.048|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0480
91619656|NCT00243230|183131920|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
91659174|NCT03506386|183212574|OTHER||||||<|0.0001||||||Statistical differences among eligible performed, eligible not performed and not eligible participants were estimated by Log Rank test.|Log Rank|||||||< 0.0001
91659175|NCT05615935|183212577|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|2.07|||<|0.001|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||Using G\*Power 3.1, the required sample size for ANCOVA with two groups was estimated with a significance level of 0.05, statistical power of 0.80, and an effect size of 0.35, based on Cohen's guidelines for a medium-to-large effect commonly applied in behavioral research (Cohen, 1988). Assuming up to two covariates, a minimum of 67 participants was required. Accounting for a 10% attrition rate, the final target was set at 74 participants.||||<0.001
91659176|NCT05615935|183212578|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|4.58||||0.15|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||||||0.15
91659177|NCT05615935|183212578|SUPERIORITY||Median Difference (Final Values)|-2.64|STANDARD_DEVIATION|6.35||0.02|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|t-test, 2 sided|||||||0.02
91659178|NCT02567968|183212583|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
91659179|NCT00048581|183212593|SUPERIORITY_OR_OTHER||Est. Weighted. Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.6|41.1||The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be \~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||41.1|20.6|<0.001
91659180|NCT00048581|183212594|SUPERIORITY_OR_OTHER||Est. of Weighted Diff: Day 169 HAQ|24.0|||<|0.001|TWO_SIDED|95.0|13.8|34.2||If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.|The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||34.2|13.8|<0.001
91619657|NCT00243230|183131920|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
91619658|NCT00243230|183131922|SUPERIORITY|||||||0.0225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0225
91619659|NCT00243230|183131922|SUPERIORITY|||||||0.0582|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0582
91619660|NCT00243230|183131923|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
91619661|NCT00243230|183131923|SUPERIORITY|||||||0.0038|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0038
91619662|NCT00243230|183131924|SUPERIORITY|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0002
91659181|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 20|12.3||||0.001|TWO_SIDED|95.0|4.6|20.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||20.0|4.6|0.001
91524698|NCT03885011|182924691|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
91619663|NCT00243230|183131924|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0004
91619664|NCT00471445|183131951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.19||0.363|TWO_SIDED|95.0|-0.548|0.201|||ANCOVA|||Tested at the two-sided 0.05 significance level.||0.201|-0.548|0.363
91619665|NCT00831441|183132059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.5094|TWO_SIDED|95.0|0.8|1.11|||Cox proportional hazard models|||A test of superiority at the one-sided α = 0.025 significance level for the primary efficacy outcome was performed.||1.11|0.80|0.5094
91619666|NCT00831441|183132060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6702|TWO_SIDED|95.0|0.7|1.26|||Cox proportional hazard models|||||1.26|0.70|0.6702
91619667|NCT00831441|183132061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.6311|TWO_SIDED|95.0|0.57|1.4|||Cox proportional hazard models|||||1.40|0.57|0.6311
91619668|NCT00831441|183132062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5086|TWO_SIDED|95.0|0.76|1.14|||Cox proportional hazard models|||||1.14|0.76|0.5086
91659182|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 50|2.3||||0.001|TWO_SIDED|95.0|-0.8|5.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||5.5|-0.8|0.001
91659183|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 70|0.8||||0.784|TWO_SIDED|95.0|-1.3|2.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||2.9|-1.3|0.784
91619669|NCT00831441|183132063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1502|TWO_SIDED|95.0|0.47|1.12|||Cox proportional hazard models|||||1.12|0.47|0.1502
91619670|NCT00831441|183132064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4317|TWO_SIDED|95.0|0.82|1.09|||Cox proportional hazard models|||||1.09|0.82|0.4317
91619671|NCT00831441|183132065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8015|TWO_SIDED|95.0|0.83|1.15|||Cox proportional hazard models|||||1.15|0.83|0.8015
91619672|NCT00831441|183132066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8948|TWO_SIDED|95.0|0.85|1.15|||Cox proportional hazard models|||||1.15|0.85|0.8948
91659184|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 20|14.0||||0.005|TWO_SIDED|95.0|4.0|24.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||24.0|4.0|0.005
91659185|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 50|5.6||||0.06|TWO_SIDED|95.0|-0.2|11.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||11.4|-0.2|0.06
91713129|NCT05464420|183317610|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.95|1.32|||||V116 Lot 1/V116 Lot 2|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.32|0.95|
91713130|NCT05464420|183317610|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.86|
91619673|NCT00831441|183132067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.59||||0.0006|TWO_SIDED|95.0|1.5|4.46|||Cox Proportional Hazard model|||A point estimate and two-sided 95% confidence interval (CI) for relative risk, as measured by the hazard ratio and a p-value for the test of equality of rates (HR = 1) was calculated.||4.46|1.50|0.0006
91619674|NCT00831441|183132068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48|||<|0.0001|TWO_SIDED|95.0|1.72|3.58|||Cox Proportional Hazard model|||||3.58|1.72|<0.0001
91619675|NCT00831441|183132069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.87|3.72|||Cox Proportional Hazard model|||||3.72|1.87|<0.0001
91619676|NCT00831441|183132070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36|||<|0.0001|TWO_SIDED|95.0|2.06|2.7|||Cox Proportional Hazard model|||||2.70|2.06|<0.0001
91619677|NCT00485589|183132077|NON_INFERIORITY|Pre-specified analysis||||||0.001|||||||Van Elteren's test|||||||0.001
91619678|NCT00485589|183132077|NON_INFERIORITY|Pre-specified analysis||||||0.0033|||||||Van Elteren's test|||||||0.0033
91619679|NCT01205451|183132092|SUPERIORITY_OR_OTHER||t-distribution|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.38|-1.04||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.04|-1.38|<0.0001
91619680|NCT01205451|183132092|SUPERIORITY_OR_OTHER||t-distribution|-1.33|||<|0.0001|TWO_SIDED|95.0|-1.54|-1.12||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.12|-1.54|<0.0001
91619681|NCT01205451|183132092|SUPERIORITY_OR_OTHER||t-distribution|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.72||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.72|-1.04|<0.0001
91619682|NCT01205451|183132092|SUPERIORITY_OR_OTHER||t-distribution|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.91||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.91|-1.33|<0.0001
91619683|NCT03607838|183132175|SUPERIORITY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|3.35||0.0263|TWO_SIDED|95.0|-14.1|-0.9|||Mixed Models Analysis|||||-0.9|-14.1|0.0263
91713131|NCT05464420|183317610|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.77|
91619684|NCT03607838|183132176|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|3.4||0.0558|TWO_SIDED|95.0|-13.2|0.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||0.2|-13.2|0.0558
91659186|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 70|1.6||||0.473|TWO_SIDED|95.0|-1.8|4.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||4.9|-1.8|0.473
91659187|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 20|22.0|||<|0.001|TWO_SIDED|95.0|11.3|32.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||32.8|11.3|<0.001
91659188|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 50|6.5||||0.076|TWO_SIDED|95.0|-0.6|13.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.7|-0.6|0.076
91659189|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 70|5.1||||0.019|TWO_SIDED|95.0|0.7|9.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.4|0.7|0.019
91619685|NCT03607838|183132177|SUPERIORITY||Mean Difference (Final Values)|-25.8|STANDARD_ERROR_OF_MEAN|15.24||0.092|TWO_SIDED|95.0|-55.7|4.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||4.2|-55.7|0.0920
91659190|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 20|28.0|||<|0.001|TWO_SIDED|95.0|17.4|38.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||38.7|17.4|<0.001
91713132|NCT05464420|183317610|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
91713133|NCT05464420|183317610|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.9|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.90|
91713134|NCT05464420|183317610|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.93|1.21|||||V116 Lot 2/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.93|
91619686|NCT03607838|183132178|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.95||0.0336|TWO_SIDED|95.0|-8.0|-0.3||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||-0.3|-8.0|0.0336
91619687|NCT00798694|183132189|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months."||||0.005
91619688|NCT03709810|183132195|SUPERIORITY||Geometric Mean Ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.12|0.3|||ANOVA|Log10 peanuts mass as response variable, study product and period as fixed explanatory effects, and participant as a random effect.|GMR=(Experimental denture adhesive/ No Adhesive)|||0.30|0.12|<0.0001
91619689|NCT02665364|183132287|SUPERIORITY||arithmetic mean|-30.2802|STANDARD_ERROR_OF_MEAN|5.2588|<|0.0001|TWO_SIDED|95.0|-40.6653|-19.8951|||ANCOVA|||The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.||-19.8951|-40.6653|< 0.0001
91619690|NCT02665364|183132288|SUPERIORITY||Odds Ratio (OR)|1.38||||0.34|TWO_SIDED|95.0|0.716|2.657|||Regression, Logistic|||Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.657|0.716|0.34
91619691|NCT02665364|183132289|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6243|TWO_SIDED|95.0|0.602|2.329|||Regression, Logistic|||The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.329|0.602|0.6243
91619692|NCT02665364|183132290|SUPERIORITY|||||||0.0022|||||||Pearson's Chi-squared|||||||0.0022
91619693|NCT02665364|183132291|SUPERIORITY|||||||0.7946|||||||Wilcoxon (Mann-Whitney)|||Baseline to last available value between W24 and W36||||0.7946
91619694|NCT02665364|183132292|SUPERIORITY|||||||0.9224|||||||student - pooled|||||||0.9224
91619695|NCT02665364|183132293|SUPERIORITY|||||||0.3258|||||||student - pooled|||||||0.3258
91619696|NCT02665364|183132294|SUPERIORITY|||||||0.6169|||||||Student - Satterthwaite|||||||0.6169
91659191|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 50|12.0||||0.002|TWO_SIDED|95.0|4.1|19.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||19.8|4.1|0.002
91713135|NCT05464420|183317610|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.86|
91619697|NCT02665364|183132295|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0796|TWO_SIDED|95.0|0.932|3.524|||Regression, Logistic|||||3.524|0.932|0.0796
91619698|NCT02665364|183132296|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0762|TWO_SIDED|95.0|0.938|3.574|||Regression, Logistic|||||3.574|0.938|0.0762
91619699|NCT02665364|183132299|SUPERIORITY|||||||0.0097|||||||Student - Satterthwaite|||||||0.0097
91619700|NCT02665364|183132300|SUPERIORITY|||||||0.0425|||||||Pearson's Chi-squared|||||||0.0425
91619701|NCT02665364|183132301|SUPERIORITY|||||||0.0396|||||||Pearson's Chi-squared|||||||0.0396
91619702|NCT03025217|183132308|OTHER||Cohen's d|0.33||||0.095|TWO_SIDED||||||t-test, 2 sided|||||||.095
91619703|NCT03025217|183132309|OTHER||Cohen's d|0.75||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
91619704|NCT01088438|183132317|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.||||<0.001
91713136|NCT05464420|183317610|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
91619705|NCT01088438|183132318|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.||||<.001
91619706|NCT01088438|183132319|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Chi-squared|1 df||Null hypothesis is equal proportion of encounters probed in control and intervention groups.||||0.85
91619707|NCT01019486|183132340|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis||||<0.05
91619708|NCT01019486|183132340|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis.||||<0.05
91619709|NCT01019486|183132340|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between groups with two-tailed analysis||||<0.05
91619710|NCT01019486|183132341|NON_INFERIORITY_OR_EQUIVALENCE|If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.|None insufficient data|2.0||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||No analysis was performed due to limited data.||||0.05
91619711|NCT01019486|183132342|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Comparison between groups using a two-tailed Student t test||||<.05
91619712|NCT02724774|183132347|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||All analyses were conducted as intention-to-treat, analyzing all 252 cases as randomly assigned to the PFR and control group (CG). Multiple linear regression was used to examine the treatment effect of PFR (0 = CG, 1 = PFR). Covariates included preferred language (0 = English, 1 = Spanish) and the baseline measure.||||.026
91619713|NCT02724774|183132348|SUPERIORITY|||||||0.154||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.154
91619714|NCT02724774|183132349|SUPERIORITY|||||||0.516||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.516
91619715|NCT02724774|183132350|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||<0.001
91619716|NCT02724774|183132351|SUPERIORITY|||||||0.094||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||0.094
91619717|NCT02724774|183132352|SUPERIORITY|||||||0.029|||||||Regression, Linear|||||||0.029
91619718|NCT02724774|183132353|SUPERIORITY|||||||0.389||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.389
91619719|NCT02724774|183132354|SUPERIORITY|||||||0.747||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.747
91619720|NCT00441103|183132376|SUPERIORITY_OR_OTHER||||||<|0.001||||||Non-parametric analysis of variance (ANOVA) with effects for treatment and the absence/presence of Gd-enhancing lesions at baseline as factors|ANOVA|||||||<0.001
91619721|NCT00441103|183132377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_DEVIATION|2.33|<|0.001|||||||Wilcoxon signed-rank test|||Mean difference was calculated by subtracting 'Day 1 up to Week 16' from 'Week 17 up to Week 40' and analyzed using Wilcoxon signed-rank test.||||<0.001
91791724|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.062|TWO_SIDED|97.5|-0.22|0.02|||mixed-effects model|||Month 5||0.02|-0.22|0.062
91659192|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 70|5.1||||0.033|TWO_SIDED|95.0|0.4|9.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.8|0.4|0.033
91659193|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 20|25.9|||<|0.001|TWO_SIDED|95.0|15.1|36.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||36.8|15.1|<0.001
91659194|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 50|14.2|||<|0.001|TWO_SIDED|95.0|6.6|21.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||21.9|6.6|<0.001
91619722|NCT05836818|183132389|SUPERIORITY||Adjusted difference|25.1|||<|0.0001|TWO_SIDED|95.0|17.0|33.2|||Regression, Logistic|Mixed effects logistic regression with a random center effect for within-center characteristics, and terms for calendar time and intervention||Adjusted difference 25.1 percentage points||33.2|17|<0.0001
91619723|NCT01627067|183132416|NON_INFERIORITY|The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months.|Cox Proportional Hazard|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Regression, Cox|||Data for PFS were censored at the time of a patient's removal from study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months. The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study.||0.76|0.08|0.015
91619724|NCT01627067|183132419|OTHER||Hazard Ratio (HR)|0.6||||0.31|TWO_SIDED|95.0|0.22|1.62|||Regression, Cox|||||1.62|0.22|0.31
91659195|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 70|7.8||||0.002|TWO_SIDED|95.0|2.6|13.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.0|2.6|0.002
91659196|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 20|35.5|||<|0.001|TWO_SIDED|95.0|24.6|46.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||46.5|24.6|<0.001
91692403|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|2.7|9.7||||||60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||9.7|2.7|
91791725|NCT01931670|183461145|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.46|-0.22|||mixed-effects model|||Month 5||-0.22|-0.46|< 0.001
91791726|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-3.04|STANDARD_ERROR_OF_MEAN|2.94||0.301|TWO_SIDED|97.5|-9.64|3.56|||mixed-effects model|||Month 1||3.56|-9.64|0.301
91791727|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-6.43|STANDARD_ERROR_OF_MEAN|2.92||0.028|TWO_SIDED|97.5|-12.99|0.13|||mixed-effects model|||Month 1||0.13|-12.99|0.028
91619725|NCT00926796|183132420|SUPERIORITY_OR_OTHER||Proportion of cured participants|100.0|||<|0.05|ONE_SIDED|95.0|98.53||||Exact binomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence limit is \>=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||98.53|<0.05
91713137|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|
91619726|NCT00926796|183132427|SUPERIORITY_OR_OTHER||Proportion of cured participants|99.5|||<|0.05|ONE_SIDED|95.0|97.64||||Exact bionomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||97.64|<0.05
91619727|NCT00621855|183132464|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
91619728|NCT00621855|183132467|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
91619729|NCT01274338|183132503|SUPERIORITY|||||||0.065||||||This design provides at least 80% power at a one sided type I error rate of 0.003.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.065
91619730|NCT01274338|183132504|SUPERIORITY|This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.||||||0.044|||||||Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.044
91619731|NCT01274338|183132506|SUPERIORITY|||||||0.289||||||If low dose Ipi (LIP) vs. HDI is significant for OS at the 2.2% level, then we will compare high dose Ipi (HIP) vs. HDI at the 2.2% level.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.289
91619732|NCT02924688|183132521|SUPERIORITY||Least Squares Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.052|0.139||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study inhaled corticosteroids (ICS) dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.139|0.052|<0.001
91713138|NCT05464420|183317610|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
91619733|NCT02924688|183132521|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.066|0.153||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.153|0.066|<0.001
91619734|NCT02924688|183132521|SUPERIORITY||Least Squares Mean Difference|0.082|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.039|0.125||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.125|0.039|<0.001
91619735|NCT02924688|183132521|SUPERIORITY||Least Squares Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.049|0.135||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.135|0.049|<0.001
91619736|NCT02924688|183132522|SUPERIORITY||Rate Ratio|0.97||||0.778|TWO_SIDED|95.0|0.81|1.17||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.17|0.81|0.778
91619737|NCT02924688|183132522|SUPERIORITY||Rate Ratio|0.87||||0.151|TWO_SIDED|95.0|0.72|1.05||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.05|0.72|0.151
91619738|NCT02924688|183132523|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using Analysis of Covariance (ANCOVA) with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
91713139|NCT05464420|183317610|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03|||||V116 Lot 1/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.77|
91713140|NCT05464420|183317610|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.74|0.98|||||V116 Lot 2/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|0.98|0.74|
91713141|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
91713142|NCT05464420|183317610|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.83|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.83|
91713143|NCT05464420|183317610|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||V116 Lot 2/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
91713144|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 1/V116 Lot 2|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
91713145|NCT05464420|183317610|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.91|
91713146|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
91713147|NCT05464420|183317610|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.80|
91713148|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.84|
91713149|NCT05464420|183317610|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.89|
91713150|NCT05464420|183317610|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
91713151|NCT05464420|183317610|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.83|1.11|||||V116 Lot 1/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.83|
91713152|NCT05464420|183317610|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
91713153|NCT05464420|183317610|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.91|1.23|||||V116 Lot 1/V116 Lot 2|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.91|
91713154|NCT05464420|183317610|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.89|
91713155|NCT05464420|183317610|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|
91713156|NCT05464420|183317610|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.03|||||V116 Lot 1/V116 Lot 2|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.78|
91713157|NCT05464420|183317610|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.78|
91713158|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
91713159|NCT05464420|183317610|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
91713160|NCT05464420|183317610|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.23|||||V116 Lot 1/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.93|
91713161|NCT05464420|183317610|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.88|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.88|
91713162|NCT05464420|183317610|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
91713163|NCT05464420|183317610|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.79|
91713164|NCT05464420|183317610|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|
91713165|NCT05464420|183317610|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.1|||||V116 Lot 1/V116 Lot 2|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.83|
91713166|NCT05464420|183317610|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||V116 Lot 1/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
91713167|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.16|||||V116 Lot 2/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|
91713168|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
91713169|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
91713170|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
91713171|NCT05464420|183317610|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.84|
91713172|NCT05464420|183317610|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.83|
91791728|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-5.17|STANDARD_ERROR_OF_MEAN|2.964||0.082|TWO_SIDED|97.5|-11.82|1.49|||mixed-effects model|||Month 2||1.49|-11.82|0.082
91713173|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.85|
91713174|NCT05464420|183317610|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
91713175|NCT05464420|183317610|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||V116 Lot 1/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.79|
91713176|NCT05464420|183317610|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.77|
91619739|NCT02924688|183132523|SUPERIORITY||Least Squares Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.067|0.155||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.155|0.067|<0.001
91619740|NCT02924688|183132523|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
91619741|NCT02924688|183132523|SUPERIORITY||Least Squares Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.074|0.162||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.162|0.074|<0.001
91619742|NCT02924688|183132524|SUPERIORITY||Least Squares Mean Difference|-0.057|STANDARD_ERROR_OF_MEAN|0.034||0.094|TWO_SIDED|95.0|-0.124|0.01||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.010|-0.124|0.094
91713177|NCT05464420|183317610|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||V116 Lot 1/V116 Lot 2|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.80|
91713178|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.19|||||V116 Lot 1/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.19|0.84|
91713179|NCT05464420|183317610|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|
91713180|NCT05464420|183317610|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||V116 Lot 1/V116 Lot 2|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.00|0.77|
91791729|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.956|<|0.001|TWO_SIDED|97.5|-19.83|-6.55|||mixed-effects model|||Month 2||-6.55|-19.83|< 0.001
91619743|NCT02924688|183132524|SUPERIORITY||Least Squares Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.0338||0.008|TWO_SIDED|95.0|-0.156|-0.023||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||-0.023|-0.156|0.008
91619744|NCT02924688|183132525|OTHER||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.697||0.115|TWO_SIDED|95.0|-0.27|2.47||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.47|-0.27|0.115
91619745|NCT02924688|183132525|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.692||0.662|TWO_SIDED|95.0|-1.66|1.05||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.05|-1.66|0.662
91619746|NCT02924688|183132526|OTHER||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.185||0.479|TWO_SIDED|95.0|-0.49|0.23||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||0.23|-0.49|0.479
91713181|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.14|||||V116 Lot 1/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.88|
91713182|NCT05464420|183317610|OTHER||GMC Ratio|1.14|||||TWO_SIDED|95.0|1.0|1.3|||||V116 Lot 2/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.30|1.00|
91713183|NCT05464420|183317610|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.89|
91713184|NCT05464420|183317610|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
91713185|NCT05464420|183317610|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 2/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
91713186|NCT05464420|183317610|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.17|||||V116 Lot 1/V116 Lot 2|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.90|
91791730|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-6.84|STANDARD_ERROR_OF_MEAN|3.379||0.043|TWO_SIDED|97.5|-14.43|0.75|||mixed-effects model|||Month 3||0.75|-14.43|0.043
91791731|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-19.05|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|97.5|-26.61|-11.49|||mixed-effects model|||Month 3||-11.49|-26.61|< 0.001
91791732|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-6.25|STANDARD_ERROR_OF_MEAN|3.473||0.072|TWO_SIDED|97.5|-14.05|1.55|||mixed-effects model|||Month 4||1.55|-14.05|0.072
91791733|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-21.58|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|97.5|-29.35|-13.81|||mixed-effects model|||Month 4||-13.81|-29.35|< 0.001
91791734|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-6.21|STANDARD_ERROR_OF_MEAN|3.536||0.08|TWO_SIDED|97.5|-14.15|1.73|||mixed-effects model|||Month 5||1.73|-14.15|0.08
91791735|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-21.66|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|97.5|-29.56|-13.75|||mixed-effects model|||Month 5||-13.75|-29.56|< 0.001
91713187|NCT05464420|183317610|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
91713188|NCT05464420|183317610|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||V116 Lot 2/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|
91713189|NCT05464420|183317611|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|1.01|1.21|||||V116 Combined Lots/PPSV23|Serotype 3: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|1.01|
91713190|NCT05464420|183317611|OTHER||GMC Ratio|3.91|||||TWO_SIDED|95.0|3.43|4.45|||||V116 Combined Lots/PPSV23|Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|4.45|3.43|
91713191|NCT05464420|183317611|OTHER||GMC Ratio|1.54|||||TWO_SIDED|95.0|1.38|1.72|||||V116 Combined Lots/PPSV23|Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.72|1.38|
91713192|NCT05464420|183317611|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.89|||||V116 Combined Lots/PPSV23|Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.89|0.73|
91713193|NCT05464420|183317611|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.14|||||V116 Combined Lots/PPSV23|Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.91|
91713194|NCT05464420|183317611|OTHER||GMC Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.66|||||V116 Combined Lots/PPSV23|Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.66|1.30|
91713195|NCT05464420|183317611|OTHER||GMC Ratio|1.38|||||TWO_SIDED|95.0|1.26|1.52|||||V116 Combined Lots/PPSV23|Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.52|1.26|
91713196|NCT05464420|183317611|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.23|1.62|||||V116 Combined Lots/PPSV23|Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.62|1.23|
91713197|NCT05464420|183317611|OTHER||GMC Ratio|6.82|||||TWO_SIDED|95.0|6.08|7.65|||||V116 Combined Lots/PPSV23|Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.65|6.08|
91791736|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-10.83|STANDARD_ERROR_OF_MEAN|3.744||0.004|TWO_SIDED|97.5|-19.24|-2.43|||mixed-effects model|||Month 6||-2.43|-19.24|0.004
91713198|NCT05464420|183317611|OTHER||GMC Ratio|3.24|||||TWO_SIDED|95.0|2.86|3.67|||||V116 Combined Lots/PPSV23|Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|3.67|2.86|
91713199|NCT05464420|183317611|OTHER||GMC Ratio|6.48|||||TWO_SIDED|95.0|5.83|7.19|||||V116 Combined Lots/PPSV23|Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.19|5.83|
91713200|NCT05464420|183317611|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.66|2.07|||||V116 Combined Lots/PPSV23|Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|2.07|1.66|
91713201|NCT05464420|183317611|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||||V116 Combined Lots/PPSV23|Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.22|0.98|
91791737|NCT01931670|183461146|SUPERIORITY||LS Mean of Difference|-21.16|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-29.54|-12.79|||mixed-effects model|||Month 6||-12.79|-29.54|< 0.001
91713202|NCT05464420|183317611|OTHER||GMC Ratio|1.53|||||TWO_SIDED|95.0|1.37|1.71|||||V116 Combined Lots/PPSV23|Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.71|1.37|
91713203|NCT05464420|183317611|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.17|1.49|||||V116 Combined Lots/PPSV23|Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.49|1.17|
91713204|NCT05464420|183317611|OTHER||GMC Ratio|8.14|||||TWO_SIDED|95.0|7.19|9.23|||||V116 Combined Lots/PPSV23|Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|9.23|7.19|
91713205|NCT05464420|183317611|OTHER||GMC Ratio|5.74|||||TWO_SIDED|95.0|5.08|6.48|||||V116 Combined Lots/PPSV23|Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|6.48|5.08|
91713206|NCT05464420|183317611|OTHER||GMC Ratio|14.47|||||TWO_SIDED|95.0|12.77|16.4|||||V116 Combined Lots/PPSV23|Serotype 24F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|16.40|12.77|
91713207|NCT05464420|183317611|OTHER||GMC Ratio|9.55|||||TWO_SIDED|95.0|8.61|10.59|||||V116 Combined Lots/PPSV23|Serotype 31: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|10.59|8.61|
91713208|NCT05464420|183317611|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.91|||||V116 Combined Lots/PPSV23|Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.91|0.73|
91713209|NCT05464420|183317611|OTHER||GMC Ratio|7.06|||||TWO_SIDED|95.0|6.41|7.77|||||V116 Combined Lots/PPSV23|Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.77|6.41|
91713210|NCT00627926|183317631|SUPERIORITY_OR_OTHER||Difference in percentage|23.0|||||TWO_SIDED|95.0|15.9|30.0||||||||30.0|15.9|
91713211|NCT00627926|183317631|SUPERIORITY_OR_OTHER||Difference in percentage|29.2|||||TWO_SIDED|95.0|22.4|36.1||||||||36.1|22.4|
91713212|NCT00627926|183317632|SUPERIORITY_OR_OTHER||Difference in percentage|57.1|||||TWO_SIDED|95.0|51.4|62.8||||||||62.8|51.4|
91713213|NCT00627926|183317632|SUPERIORITY_OR_OTHER||Difference in percentage|58.4|||||TWO_SIDED|95.0|52.7|64.0||||||||64.0|52.7|
91713214|NCT00627926|183317633|SUPERIORITY_OR_OTHER||Difference in percentage|48.8|||||TWO_SIDED|95.0|43.0|54.6||||||||54.6|43.0|
91713215|NCT00627926|183317633|SUPERIORITY_OR_OTHER||Difference in percentage|50.4|||||TWO_SIDED|95.0|44.6|56.2||||||||56.2|44.6|
91713216|NCT00627926|183317634|SUPERIORITY_OR_OTHER||Difference in percentage|35.7|||||TWO_SIDED|95.0|29.0|42.4||||||||42.4|29.0|
91713217|NCT00627926|183317634|SUPERIORITY_OR_OTHER||Difference in percentage|37.5|||||TWO_SIDED|95.0|30.9|44.1||||||||44.1|30.9|
91713218|NCT00627926|183317635|SUPERIORITY_OR_OTHER||Difference in percentage|17.6|||||TWO_SIDED|95.0|11.2|24.0||||||||24.0|11.2|
91713219|NCT00627926|183317635|SUPERIORITY_OR_OTHER||Difference in percentage|23.1|||||TWO_SIDED|95.0|17.0|29.2||||||||29.2|17.0|
91713220|NCT00627926|183317636|SUPERIORITY_OR_OTHER||Difference in percentage|25.5|||||TWO_SIDED|95.0|18.5|32.4||||||||32.4|18.5|
91791738|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.688|TWO_SIDED|97.5|-0.11|0.16|||mixed-effects model|||Month 1||0.16|-0.11|0.688
91619747|NCT02924688|183132526|OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.023|TWO_SIDED|95.0|-0.78|-0.06||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||-0.06|-0.78|0.023
91619748|NCT02924688|183132529|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.75||0.172|TWO_SIDED|95.0|-2.5|0.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.4|-2.5|0.172
91619749|NCT02924688|183132529|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.74||0.436|TWO_SIDED|95.0|-2.0|0.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.9|-2.0|0.436
91619750|NCT02924688|183132529|OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.426|TWO_SIDED|95.0|-0.9|2.1||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.1|-0.9|0.426
91619751|NCT02924688|183132529|OTHER||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.74||0.349|TWO_SIDED|95.0|-0.8|2.2||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.2|-0.8|0.349
91619752|NCT02924688|183132529|OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.482|TWO_SIDED|95.0|-1.5|0.7||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||0.7|-1.5|0.482
91659197|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 50|20.9|||<|0.001|TWO_SIDED|95.0|12.2|29.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||29.5|12.2|<0.001
91659198|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 70|10.2|||<|0.001|TWO_SIDED|95.0|4.4|16.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||16.0|4.4|<0.001
91659199|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.0|41.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||41.7|20.0|<0.001
91713221|NCT00627926|183317636|SUPERIORITY_OR_OTHER||Difference in percentage|31.2|||||TWO_SIDED|95.0|24.4|37.9||||||||37.9|24.4|
91791739|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.431|TWO_SIDED|97.5|-0.18|0.08|||mixed-effects model|||Month 1||0.08|-0.18|0.431
91619753|NCT02924688|183132529|OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.56||0.142|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.9|-0.3|0.142
91619754|NCT02924688|183132529|OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.806|TWO_SIDED|95.0|-1.2|1.0||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.0|-1.2|0.806
91619755|NCT02924688|183132529|OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.447|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.5|-0.7|0.447
91619756|NCT02924688|183132530|OTHER||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.61||0.034|TWO_SIDED|95.0|0.1|2.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.5|0.1|0.034
91619757|NCT02924688|183132530|OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.839|TWO_SIDED|95.0|-1.1|1.3||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.3|-1.1|0.839
91659200|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 50|16.6|||<|0.001|TWO_SIDED|95.0|8.6|24.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||24.5|8.6|<0.001
91659201|NCT00048581|183212595|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 70|8.7||||0.003|TWO_SIDED|95.0|2.7|14.6|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||14.6|2.7|0.003
91659202|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 PCS|3.63|||<|0.001|TWO_SIDED|95.0|1.89|5.38|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.38|1.89|<0.001
91659203|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 MCS|2.57||||0.017|TWO_SIDED|95.0|0.47|4.67|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.67|0.47|0.017
91659204|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Physical Function|1.7||||0.052|TWO_SIDED|95.0|-0.01|3.41|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.41|-0.01|0.052
91659205|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role-Physical|3.01||||0.007|TWO_SIDED|95.0|0.83|5.19|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.19|0.83|0.007
91659206|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Bodily Pain|5.62|||<|0.001|TWO_SIDED|95.0|3.77|7.47|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.47|3.77|<0.001
91659207|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: General Health|2.51||||0.001|TWO_SIDED|95.0|0.99|4.02|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.02|0.99|0.001
91659208|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Vitality|3.17||||0.001|TWO_SIDED|95.0|1.24|5.1|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.10|1.24|0.001
91713222|NCT00627926|183317637|SUPERIORITY_OR_OTHER||Difference in percentage|25.2|||||TWO_SIDED|95.0|18.2|32.2||||||||32.2|18.2|
91713223|NCT00627926|183317637|SUPERIORITY_OR_OTHER||Difference in percentage|31.7|||||TWO_SIDED|95.0|24.9|38.5||||||||38.5|24.9|
91659209|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Social Functioning|4.69|||<|0.001|TWO_SIDED|95.0|2.59|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.59|<0.001
91659210|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role Emotional|0.97||||0.494|TWO_SIDED|95.0|-1.82|3.77|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.77|-1.82|0.494
91659211|NCT00048581|183212616|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Mental Health|2.59||||0.009|TWO_SIDED|95.0|0.65|4.54|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.54|0.65|0.009
91659212|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 PCS|5.46|||<|0.001|TWO_SIDED|95.0|3.64|7.29|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.29|3.64|<0.001
91659213|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 MCS|3.04||||0.005|TWO_SIDED|95.0|0.91|5.17|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.17|0.91|0.005
91659214|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Physical Function|4.03|||<|0.001|TWO_SIDED|95.0|2.08|5.98|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.98|2.08|<0.001
91659215|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role-Physical|5.22|||<|0.001|TWO_SIDED|95.0|3.1|7.35|||ANCOVA|||||7.35|3.10|<0.001
91659216|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Bodily Pain|6.24|||<|0.001|TWO_SIDED|95.0|4.37|8.11|||ANCOVA|||||8.11|4.37|<0.001
91791740|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.277|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||Month 2||0.07|-0.20|0.277
91527478|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|30.0||||0.1046|TWO_SIDED|95.0|-6.22|66.22|||random coefficient regression|||In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.||66.22|-6.22|0.1046
91659217|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 General Health|3.27|||<|0.001|TWO_SIDED|95.0|1.64|4.9|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.90|1.64|<0.001
91659218|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Vitality|4.78|||<|0.001|TWO_SIDED|95.0|2.76|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.76|<0.001
91791741|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|97.5|-0.37|-0.1|||mixed-effects model|||Month 2||-0.10|-0.37|< 0.001
91791742|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.071||0.494|TWO_SIDED|97.5|-0.21|0.11|||mixed-effects model|||Month 4||0.11|-0.21|0.494
91791743|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.43|-0.11|||mixed-effects model|||Month 4||-0.11|-0.43|< 0.001
91791744|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.765|TWO_SIDED|97.5|-0.18|0.14|||mixed-effects model|||Month 5||0.14|-0.18|0.765
91791745|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.073|<|0.001|TWO_SIDED|97.5|-0.47|-0.15|||mixed-effects model|||Month 5||-0.15|-0.47|< 0.001
91791746|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_DEVIATION|0.076||0.468|TWO_SIDED|97.5|-0.23|0.12|||mixed-effects model|||Month 6||0.12|-0.23|0.468
91791747|NCT01931670|183461147|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.5|-0.16|||mixed-effects model|||Month 6||-0.16|-0.50|< 0.001
91791748|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.029|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.029
91791749|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|97.5|-0.2|-0.03|||mixed-effects model|||Month 1||-0.03|-0.20|0.004
91791750|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.042||0.076|TWO_SIDED|97.5|-0.17|0.02|||mixed-effects model|||Month 2||0.02|-0.17|0.076
91791751|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|97.5|-0.28|-0.09|||mixed-effects model|||Month 2||-0.09|-0.28|< 0.001
91619758|NCT02924688|183132530|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.349|TWO_SIDED|95.0|-1.8|0.6||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.6|-1.8|0.349
91619759|NCT02924688|183132530|OTHER||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.61||0.768|TWO_SIDED|95.0|-1.0|1.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.4|-1.0|0.768
91659219|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Social Functioning|4.92|||<|0.001|TWO_SIDED|95.0|2.71|7.12|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.12|2.71|<0.001
91659220|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role Emotional|3.54||||0.013|TWO_SIDED|95.0|0.74|6.33|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.33|0.74|0.013
91713224|NCT00627926|183317642|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||||TWO_SIDED|95.0|17.9|31.9||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||31.9|17.9|
91713225|NCT00627926|183317642|SUPERIORITY_OR_OTHER||Difference in percentage|30.9|||||TWO_SIDED|95.0|24.1|37.7||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||37.7|24.1|
91713226|NCT00627926|183317642|SUPERIORITY_OR_OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|18.8|32.6||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||32.6|18.8|
91791752|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.058|TWO_SIDED|97.5|-0.19|0.02|||mixed-effects model|||Month 4||0.02|-0.19|0.058
91659221|NCT00048581|183212618|SUPERIORITY_OR_OTHER||Adj Diff: Mental Health|2.7||||0.006|TWO_SIDED|95.0|0.79|4.6|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.60|0.79|0.006
91659222|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: HAQ-DI|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.23|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.23|-0.44|<0.001
91659223|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Dressing and Grooming|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.14|-0.49|<0.001
91791753|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.32|-0.12|||mixed-effects model|||Month 4||-0.12|-0.32|< 0.001
91659224|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Arising|-0.32|||<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.16|-0.47|<0.001
91659225|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Eating|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.3|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.30|-0.65|<0.001
91791754|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.284|TWO_SIDED|97.5|-0.16|0.06|||mixed-effects model|||Month 5||0.06|-0.16|0.284
91791755|NCT01931670|183461148|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|97.5|-0.33|-0.11|||mixed-effects model|||Month 5||-0.11|-0.33|< 0.001
91713227|NCT00627926|183317642|SUPERIORITY_OR_OTHER||Difference in percentage|32.5|||||TWO_SIDED|95.0|25.9|39.2||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||39.2|25.9|
91619760|NCT03072719|183132533|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.19||||0.1774|TWO_SIDED|95.0|-0.46|0.09||From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate.|ANCOVA||Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero."||0.09|-0.46|0.1774
91619761|NCT01708941|183132546|SUPERIORITY|||||||0.49|||||||Log Rank|||The primary comparison was ipilimumab + HDI versus ipilimumab alone, across ipilimumab dose (Arms A \& C versus Arms B \& D)||||0.490
91619762|NCT01708941|183132547|SUPERIORITY|||||||0.144|||||||Log Rank|||PFS comparison of higher dose ipilimumab versus lower dose ipilimumab (Arms A \& B versus Arms C \& D)||||0.144
91619763|NCT01708941|183132548|SUPERIORITY|||||||0.691|||||||Log Rank|||||||0.691
91619764|NCT01708941|183132549|SUPERIORITY|||||||0.868|||||||Log Rank|||Comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)||||0.868
91619765|NCT03004469|183132563|OTHER||LS Mean Difference|13.6|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|5.8|21.3|||Mixed linear model|||||21.3|5.8|<.001
91619766|NCT03004469|183132564|OTHER||LS Mean Difference|12.8|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|6.5|19.1|||Mixed linear model|||||19.1|6.5|<.001
91659226|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Walking|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.09|-0.44|0.003
91713228|NCT02797678|183317653|SUPERIORITY|||||||0.061|||||||paired t-test|||||||0.061
91791756|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.56|-0.18|||ANOVA|||Month 1||-0.18|-0.56|< 0.001
91619767|NCT03004469|183132565|OTHER||LS Mean Difference|-0.4024|STANDARD_ERROR_OF_MEAN|0.4057||0.322|TWO_SIDED|95.0|-1.202|0.3971|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3971|-1.2020|0.322
91619768|NCT03004469|183132565|OTHER||LS Mean Difference|0.7237|STANDARD_ERROR_OF_MEAN|0.47799||0.131|TWO_SIDED|95.0|-0.2184|1.6657|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||1.6657|-0.2184|0.131
91619769|NCT03004469|183132566|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED|95.0|-0.3|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.2|-0.3|0.569
91619770|NCT03004469|183132566|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.129|TWO_SIDED|95.0|-0.4|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.1|-0.4|0.129
91619771|NCT03004469|183132567|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.708|TWO_SIDED|95.0|-0.2|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3|-0.2|0.708
91619772|NCT03004469|183132567|OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.2|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.7|0.2|<.001
91619773|NCT03004469|183132568|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.179|TWO_SIDED|95.0|-0.3|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.1|-0.3|0.179
91713229|NCT02797678|183317656|SUPERIORITY|||||||0.301|||||||paired t-test|||||||0.301
91713230|NCT00656175|183317667|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon sign-rank test used for statistical significance.||||0.52
91619774|NCT03004469|183132568|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.262|TWO_SIDED|95.0|-0.1|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.4|-0.1|0.262
91619775|NCT03004469|183132569|OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.03||0.103|TWO_SIDED|95.0|-3.7|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 4||0.3|-3.7|0.103
91619776|NCT03004469|183132569|OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1||0.545|TWO_SIDED|95.0|-2.8|1.5|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 8||1.5|-2.8|0.545
91619777|NCT03004469|183132569|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.842|TWO_SIDED|95.0|-2.2|1.8|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 12||1.8|-2.2|0.842
91619778|NCT03004469|183132569|OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.02||0.449|TWO_SIDED|95.0|-2.8|1.2|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 24||1.2|-2.8|0.449
91619779|NCT03004469|183132569|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.272|TWO_SIDED|95.0|-0.2|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 4||0.9|-0.2|0.272
91619780|NCT03004469|183132569|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.918|TWO_SIDED|95.0|-0.7|0.8|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 8||0.8|-0.7|0.918
91619781|NCT03004469|183132569|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.078||0.078|TWO_SIDED|95.0|-0.1|1.1|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 12||1.1|-0.1|0.078
91619782|NCT03004469|183132569|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.593|TWO_SIDED|95.0|-0.9|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 24||0.5|-0.9|0.593
91619783|NCT03004469|183132569|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.295|TWO_SIDED|95.0|-0.7|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 4||0.2|-0.7|0.295
91659227|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Hygiene|-0.22||||0.01|TWO_SIDED|95.0|-0.39|-0.05|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.05|-0.39|0.010
91659228|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Reaching|-0.43|||<|0.001|TWO_SIDED|95.0|-0.61|-0.25|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.25|-0.61|<0.001
91713231|NCT04878120|183317668|SUPERIORITY|||||||0.733||||||For interaction between study group and intervention|ANOVA|||"The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. To test the hypothesis that HCL Control with Smart Bolus Calculator reduces exposure to hypoglycemia with respect to Standard HCL Control, a mixed ANOVA was performed with LBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor."||||0.733
91619784|NCT03004469|183132569|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.926|TWO_SIDED|95.0|-0.5|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 8||0.4|-0.5|0.926
91619785|NCT03004469|183132569|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.7|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 12||0.1|-0.7|0.183
91619786|NCT03004469|183132569|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.981|TWO_SIDED|95.0|-0.4|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 24||0.5|-0.4|0.981
91619787|NCT03004469|183132569|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.041|TWO_SIDED|95.0|-2.7|-0.1|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4||-0.1|-2.7|0.041
91619788|NCT03004469|183132569|OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.67||0.562|TWO_SIDED|95.0|-1.7|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8||0.9|-1.7|0.562
91619789|NCT03004469|183132569|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.66||0.642|TWO_SIDED|95.0|-1.6|1.0|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12||1.0|-1.6|0.642
91713232|NCT04878120|183317669|SUPERIORITY|||||||0.824||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent below 70 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.824
91619790|NCT03004469|183132569|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.65||0.156|TWO_SIDED|95.0|-2.2|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24||0.4|-2.2|0.156
91619791|NCT03004469|183132569|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.824|TWO_SIDED|95.0|-0.6|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4||0.5|-0.6|0.824
91619792|NCT03004469|183132569|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.29||0.713|TWO_SIDED|95.0|-0.5|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8||0.7|-0.5|0.713
91619793|NCT03004469|183132569|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.993|TWO_SIDED|95.0|-0.6|0.6|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12||0.6|-0.6|0.993
91619794|NCT03004469|183132569|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.55|TWO_SIDED|95.0|-0.8|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24||0.4|-0.8|0.550
91619795|NCT00423735|183132579|SUPERIORITY|||||||0.99|||||||Fisher Exact|2-sided test||||||0.99
91619796|NCT01722487|183132581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.28|||Log Rank|||||0.28|0.09|<0.0001
91619797|NCT01722487|183132582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.001|TWO_SIDED|95.0|0.05|0.56|||Log Rank|||||0.56|0.05|0.0010
91619798|NCT01722487|183132583|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91619799|NCT01722487|183132584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91619800|NCT01722487|183132585|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91619801|NCT01722487|183132586|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Chi-squared|||||||.0009
91619802|NCT01722487|183132587|SUPERIORITY_OR_OTHER|||||||0.0054|||||||Chi-squared|||||||.0054
91619803|NCT01735617|183132609|SUPERIORITY_OR_OTHER||Geometric means|563.38|STANDARD_DEVIATION|162.51|||TWO_SIDED|||||||||The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.||||
91619804|NCT04570332|183132643|SUPERIORITY||rate %|25.0|||<|0.01|TWO_SIDED|95.0|12.69|41.2|||one-sided test for binomial endpoint|||The null hypothesis was H0: ORR=10% (p0) and was tested against H1: ORR\>10% at one-sided 5% significance level. Assuming an effect size of ORR=25% (pA), 40 participants provided a power of at least 80%. The minimal statistically significant ORR was 20%.||41.20|12.69|<0.01
91619805|NCT01102218|183132664|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91619806|NCT00678587|183132699|SUPERIORITY_OR_OTHER||Absolute difference in proportions|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.4|||Cochran-Mantel-Haenszel|||||62.4|43.2|<0.0001
91619807|NCT00678587|183132700|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.9|||||TWO_SIDED|95.0|-15.1|3.3||||||||3.3|-15.1|
91619808|NCT00678587|183132701|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91619809|NCT02951988|183132723|SUPERIORITY|||||||0.5305|||||||Log Rank|||||||0.5305
91619810|NCT02951988|183132723|SUPERIORITY|||||||0.4628|||||||Log Rank|||||||0.4628
91713233|NCT04878120|183317670|SUPERIORITY|||||||0.402||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent in 70-180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.402
91713234|NCT04878120|183317671|SUPERIORITY|||||||0.3||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent above 180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.300
91713235|NCT04878120|183317672|SUPERIORITY|||||||0.168||||||For interaction between study arm and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with HBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.168
91713236|NCT04878120|183317673|SUPERIORITY|||||||0.476||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with CGM coefficient of variation as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.476
91619811|NCT02951988|183132724|SUPERIORITY|||||||0.6153|||||||Log Rank|||||||0.6153
91619812|NCT02951988|183132724|SUPERIORITY|||||||0.4123|||||||Log Rank|||||||0.4123
91619813|NCT00516269|183132726|SUPERIORITY_OR_OTHER||mean difference in treat versus control|0.42|STANDARD_DEVIATION|3.3||0.54||95.0|||||Wilcoxon signed rank test|||As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 \& period 2) was used to assess the treatment effect (A versus B).||||0.54
91619814|NCT04570657|183132731|SUPERIORITY||LS mean difference|0.036||||0.267|TWO_SIDED|80.0|-0.038|0.111||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.111|-0.038|0.267
91619815|NCT04570657|183132731|SUPERIORITY||LS mean difference|0.004||||0.473|TWO_SIDED|80.0|-0.071|0.079||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.079|-0.071|0.473
91619816|NCT04570657|183132732|SUPERIORITY||LS mean difference|-0.012||||0.437|TWO_SIDED|80.0|-0.11|0.086||One-sided p-value|MMRM||Week 8: Tozorakimab Dose A - Placebo|||0.086|-0.110|0.437
91713237|NCT04878120|183317674|SUPERIORITY|||||||0.914||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with total amount of carbohydrate administered as rescue treatments as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.914
91619817|NCT04570657|183132732|SUPERIORITY||LS mean difference|0.059||||0.221|TWO_SIDED|80.0|-0.039|0.157||One-sided p-value|MMRM||Week 8: Tozorakimab Dose B - Placebo|||0.157|-0.039|0.221
91619818|NCT04570657|183132732|SUPERIORITY||LS mean difference|-0.038||||0.308|TWO_SIDED|80.0|-0.136|0.06||One-sided p-value|MMRM||Week 16: Tozorakimab Dose A - Placebo|||0.060|-0.136|0.308
91619819|NCT04570657|183132732|SUPERIORITY||LS mean difference|-0.025||||0.372|TWO_SIDED|80.0|-0.122|0.072||One-sided p-value|MMRM||Week 16: Tozorakimab Dose B - Placebo|||0.072|-0.122|0.372
91619820|NCT04570657|183132735|SUPERIORITY||LS mean difference|-0.03||||0.416|TWO_SIDED|80.0|-0.215|0.154||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.154|-0.215|0.416
91619821|NCT04570657|183132735|SUPERIORITY||LS mean difference|-0.047||||0.371|TWO_SIDED|80.0|-0.231|0.137||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.137|-0.231|0.371
91619822|NCT04570657|183132736|SUPERIORITY||Odds Ratio (OR)|1.2||||0.612|TWO_SIDED|80.0|0.76|1.9|||Chi-squared|||||1.90|0.76|0.612
91619823|NCT04570657|183132736|SUPERIORITY||Odds Ratio (OR)|1.41||||0.348|TWO_SIDED|80.0|0.88|2.25|||Chi-squared|||||2.25|0.88|0.348
91619824|NCT04570657|183132737|SUPERIORITY||Odds Ratio (OR)|0.81||||0.575|TWO_SIDED|80.0|0.5|1.31|||Chi-squared|||||1.31|0.50|0.575
91619825|NCT04570657|183132737|SUPERIORITY||Odds Ratio (OR)|0.86||||0.679|TWO_SIDED|80.0|0.53|1.38|||Chi-squared|||||1.38|0.53|0.679
91619826|NCT04570657|183132738|SUPERIORITY||LS mean difference|0.002||||0.5|TWO_SIDED|80.0|-3.825|3.828||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose A - Placebo|||3.828|-3.825|0.500
91619827|NCT04570657|183132738|SUPERIORITY||LS mean difference|-1.364||||0.324|TWO_SIDED|80.0|-5.198|2.47||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose B - Placebo|||2.470|-5.198|0.324
91619828|NCT04570657|183132738|SUPERIORITY||LS mean difference|-1.421||||0.248|TWO_SIDED|80.0|-4.103|1.26||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose A - Placebo|||1.260|-4.103|0.248
91619829|NCT04570657|183132738|SUPERIORITY||LS mean difference|-1.694||||0.21|TWO_SIDED|80.0|-4.383|0.996||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose B - Placebo|||0.996|-4.383|0.210
91619830|NCT04570657|183132738|SUPERIORITY||LS mean difference|0.691||||0.42|TWO_SIDED|80.0|-3.715|5.096||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose A - Placebo|||5.096|-3.715|0.420
91619831|NCT04570657|183132738|SUPERIORITY||LS mean difference|-3.15||||0.181|TWO_SIDED|80.0|-7.579|1.28||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose B - Placebo|||1.280|-7.579|0.181
91619832|NCT04570657|183132738|SUPERIORITY||LS mean difference|-0.663||||0.38|TWO_SIDED|80.0|-3.454|2.129||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose A - Placebo|||2.129|-3.454|0.380
91619833|NCT04570657|183132738|SUPERIORITY||LS mean difference|-1.896||||0.192|TWO_SIDED|80.0|-4.694|0.903||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose B - Placebo|||0.903|-4.694|0.192
91619834|NCT04570657|183132739|SUPERIORITY||Odds Ratio (OR)|0.93||||0.828|TWO_SIDED|80.0|0.59|1.46|||Chi-squared|||||1.46|0.59|0.828
91619835|NCT04570657|183132739|SUPERIORITY||Odds Ratio (OR)|1.07||||0.84|TWO_SIDED|80.0|0.68|1.7|||Chi-squared|||||1.70|0.68|0.840
91619836|NCT04570657|183132740|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.239|TWO_SIDED|80.0|0.8|2.0||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||2.0|0.8|0.239
91619837|NCT04570657|183132740|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.461|TWO_SIDED|80.0|0.6|1.7||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||1.7|0.6|0.461
91619838|NCT04570657|183132741|SUPERIORITY||Rate ratio|0.87||||0.346|TWO_SIDED|80.0|0.56|1.36||One-sided p-value|Negative binomial regression|||||1.36|0.56|0.346
91619839|NCT04570657|183132741|SUPERIORITY||Rate ratio|0.7||||0.166|TWO_SIDED|80.0|0.43|1.12||One-sided p-value|Negative binomial regression|||||1.12|0.43|0.166
91619840|NCT04570657|183132742|SUPERIORITY||Geometric LS mean ratio|0.869||||0.029|TWO_SIDED|80.0|0.791|0.956||One-sided p-value|MMRM|||||0.956|0.791|0.029
91619841|NCT04570657|183132742|SUPERIORITY||Geometric LS mean ratio|0.879||||0.04|TWO_SIDED|80.0|0.8|0.966||One-sided p-value|MMRM|||||0.966|0.800|0.040
91659229|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Gripping|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.15|-0.49|<0.001
91659230|NCT00048581|183212620|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Activities|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.22|-0.58|<0.001
91659231|NCT04320849|183212760|OTHER||Slope|0.0675|||||ONE_SIDED|90.0||0.106||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the extravenous region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.106||
91659232|NCT04320849|183212761|OTHER||Slope|0.199|||||ONE_SIDED|90.0||0.397||||||"The following set of hypotheses will be used to evaluate the relationship between lead stiffness and curvature in the intracardiac region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.397||
91659233|NCT04320849|183212762|OTHER||Slope|-0.015|||||ONE_SIDED|90.0||0.0123||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the connector region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.0123||
91659234|NCT02268500|183212874|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
91659235|NCT02268500|183212875|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
91659236|NCT02268500|183212876|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
91659237|NCT02268500|183212877|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
91659238|NCT02268500|183212878|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91659239|NCT01312922|183212885|SUPERIORITY||Odds Ratio (OR)|0.987||||1|TWO_SIDED|95.0|0.456|2.14|||Fisher Exact|||||2.140|0.456|1.000
91659240|NCT01312922|183212885|SUPERIORITY||Odds Ratio (OR)|1.031||||1|TWO_SIDED|95.0|0.476|2.233|||Fisher Exact|||||2.233|0.476|1.000
91659241|NCT02227121|183212896|SUPERIORITY_OR_OTHER||Percentage|92.86|||||ONE_SIDED|95.0|70.3|||||||Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination \> 65%|||70.3|
91659242|NCT02801877|183212933|SUPERIORITY|||||||0.3|||||||Log Rank|Chi square= 4.1 on 3 degrees of freedom||Log-rank test of adherence, defined as time to last engagement with mobile application suite.||||0.3
91791757|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.84|-0.46|||ANOVA|||Month 1||-0.46|-0.84|< 0.001
91619842|NCT04570657|183132743|SUPERIORITY||LS mean difference|0.023||||0.385|TWO_SIDED|80.0|-0.078|0.124||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|1 Exacerbation in Last 12 Months||0.124|-0.078|0.385
91619843|NCT04570657|183132743|SUPERIORITY||LS mean difference|-0.123||||0.06|TWO_SIDED|80.0|-0.224|-0.022||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|1 Exacerbation in Last 12 Months||-0.022|-0.224|0.060
91619844|NCT04570657|183132743|SUPERIORITY||LS mean Difference|0.077||||0.186|TWO_SIDED|80.0|-0.034|0.187||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|≥ 2 Exacerbation in Last 12 Months||0.187|-0.034|0.186
91619845|NCT04570657|183132743|SUPERIORITY||LS mean difference|0.212||||0.007|TWO_SIDED|80.0|0.102|0.322||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|≥ 2 Exacerbation in Last 12 Months||0.322|0.102|0.007
91659243|NCT02801877|183212934|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|F(3, 835)=0.19||Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.90
91659244|NCT02801877|183212935|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|F(3, 835)=0.73||Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.53
91659245|NCT00154102|183212936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.853||||0.0479|TWO_SIDED|95.0|0.728|1.0|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\<80 vs. ≥80)||1.000|0.728|0.0479
91713238|NCT02499120|183317715|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.18|TWO_SIDED|95.0|0.536|1.253||1-sided p-value was from the log-rank test stratified by stratification factors ECOG(Eastern Cooperative Oncology Group) per randomization.|Log Rank|||||1.253|0.536|0.1800
91791758|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-0.82|-0.42|||ANOVA|||Month 2||-0.42|-0.82|< 0.001
91713239|NCT02499120|183317716|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.4953|TWO_SIDED|95.0|0.669|1.495||1-sided p-value was from the log-rank test stratified by stratification factors ECOG per randomization.|Log Rank|||||1.495|0.669|0.4953
91659246|NCT00154102|183212937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.0012|TWO_SIDED|95.0|0.558|0.867|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.867|0.558|0.0012
91713240|NCT02692586|183317749|SUPERIORITY|To detect an RV/LV ratio change \> 0.12 with a power of 80% at one-sided alpha = 0.025, the necessary sample size was calculated to be ≥ 52, 31, or 21 patients (to detect RV/LV ratio changes of 0.20, 0.225, or 0.25, respectively).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
91713241|NCT02692586|183317750|SUPERIORITY|The hypothesized composite MAE rate was expected to be about 13%. The necessary sample size to detect a difference from an expected MAE rate of 13% with 80% power was calculated to be 103 patients (with a one-sided p value = 0.05).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
91713242|NCT01063855|183317768|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.837|2.542||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|ANCOVA|ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.|Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF \>0.||2.542|0.837|<0.001
91713243|NCT01063855|183317769|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6||||0.001|TWO_SIDED|95.0|4.9|22.3||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.|Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF \> 0.||22.3|4.9|0.001
91619846|NCT04570657|183132744|SUPERIORITY||Geometric LS Mean Ratio|0.63|||<|0.001|TWO_SIDED|80.0|0.559|0.71||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.710|0.559|< 0.001
91619847|NCT04570657|183132744|SUPERIORITY||Geometric LS Mean Ratio|0.675|||<|0.001|TWO_SIDED|80.0|0.599|0.76||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.760|0.599|< 0.001
91619848|NCT01079962|183132745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.701||||0.5943|TWO_SIDED|95.0|-1.89|3.29||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||Change in APP at Week 12: p-value was calculated by 2 sided t-test.||3.29|-1.89|0.5943
91619849|NCT01079962|183132746|SUPERIORITY_OR_OTHER|||||||0.8589||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.8589
91619850|NCT01079962|183132746|SUPERIORITY_OR_OTHER|||||||0.2223||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.2223
91619851|NCT01079962|183132746|SUPERIORITY_OR_OTHER|||||||0.2443||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2443
91619852|NCT01079962|183132746|SUPERIORITY_OR_OTHER|||||||0.1481||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.1481
91619853|NCT01079962|183132746|SUPERIORITY_OR_OTHER|||||||0.4188||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.4188
91619854|NCT01079962|183132746|SUPERIORITY_OR_OTHER|||||||0.1586||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1586
91619855|NCT01079962|183132747|SUPERIORITY_OR_OTHER|||||||0.2987||95.0|||||t-test, 2 sided|||Change in AIx at Week 4: p-value was calculated by 2 sided t-test.||||0.2987
91619856|NCT01079962|183132747|SUPERIORITY_OR_OTHER|||||||0.6584||95.0|||||t-test, 2 sided|||Change in AIx at Week 12: p-value was calculated by 2 sided t-test.||||0.6584
91619857|NCT01079962|183132748|SUPERIORITY_OR_OTHER|||||||0.2511||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.||||0.2511
91619858|NCT01079962|183132748|SUPERIORITY_OR_OTHER|||||||0.5007||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.||||0.5007
91619859|NCT01079962|183132749|SUPERIORITY_OR_OTHER|||||||0.9943||95.0|||||t-test, 2 sided|||Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.||||0.9943
91619860|NCT01079962|183132749|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||t-test, 2 sided|||Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.||||0.5230
91619861|NCT01079962|183132750|SUPERIORITY_OR_OTHER|||||||0.4447||95.0|||||t-test, 2 sided|||||||0.4447
91619862|NCT01079962|183132751|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.3960
91619863|NCT01079962|183132751|SUPERIORITY_OR_OTHER|||||||0.1919||95.0|||||t-test, 2 sided|||Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1919
91619864|NCT01079962|183132751|SUPERIORITY_OR_OTHER|||||||0.1896||95.0|||||t-test, 2 sided|||Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1896
91619865|NCT01079962|183132752|SUPERIORITY_OR_OTHER|||||||0.9244||95.0|||||t-test, 2 sided|||||||0.9244
91619866|NCT01079962|183132753|SUPERIORITY_OR_OTHER|||||||0.9692||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.9692
91619867|NCT01079962|183132753|SUPERIORITY_OR_OTHER|||||||0.4731||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.4731
91619868|NCT01079962|183132753|SUPERIORITY_OR_OTHER|||||||0.2876||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2876
91619869|NCT01079962|183132753|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.0420
91619870|NCT01079962|183132753|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.5100
91619871|NCT01079962|183132753|SUPERIORITY_OR_OTHER|||||||0.1207||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1207
91659247|NCT00154102|183212938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2648|TWO_SIDED|95.0|0.887|1.544|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.544|0.887|0.2648
91659248|NCT00154102|183212939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.0419|TWO_SIDED|95.0|0.774|0.995|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.995|0.774|0.0419
91791759|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.29|-0.89|||ANOVA|||Month 2||-0.89|-1.29|< 0.001
91722428|NCT04390750|183337444|OTHER|The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 2 and Control at 6 months.|Interaction coefficient|-0.1||||0.072|TWO_SIDED|95.0|-0.21|0.01|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the secondary endpoint of 6 months.||0.01|-0.21|0.072
91791760|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.84|-0.42|||ANOVA|||Month 3||-0.42|-0.84|< 0.001
91659249|NCT00154102|183212940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0093|TWO_SIDED|95.0|0.67|0.946|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.946|0.670|0.0093
91659250|NCT00154102|183212941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.7549|TWO_SIDED|95.0|0.834|1.284|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.284|0.834|0.7549
91791761|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-1.35|-0.93|||ANOVA|||Month 3||-0.93|-1.35|< 0.001
91791762|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-0.84|-0.41|||ANOVA|||Month 4||-0.41|-0.84|< 0.001
91791763|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.43|-1.0|||ANOVA|||Month 4||-1.00|-1.43|< 0.001
91791764|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.01|-0.57|||ANOVA|||Month 5||-0.57|-1.01|< 0.001
91791765|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.47|-1.02|||ANOVA|||Month 5||-1.02|-1.47|< 0.001
91791766|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.95|-0.49|||ANOVA|||Month 6||-0.49|-0.95|< 0.001
91791767|NCT01931670|183461149|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.5|-1.04|||ANOVA|||Month 6||-1.04|-1.50|< 0.001
91791768|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|97.5|-0.55|-0.01|||mixed-effects model|||Month 1||-0.01|-0.55|0.02
91619872|NCT01079962|183132755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442||||0.7561||95.0|-2.36|3.24||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||||3.24|-2.36|0.7561
91619873|NCT01072539|183132758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||<0.0001
91619874|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||||||Statistical significant level: 0.05|Chi-squared|||Geriatrc: \<65 Years Versus (VS) Geriatrc: \>=65 Years||||0.0067
91619875|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0412||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age categories: \<30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and \>=65 Years.||||0.0412
91619876|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4792||||||Statistical significant level: 0.05|Chi-squared|||Sex: Male VS Sex: Female||||0.4792
91791769|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.119|<|0.001|TWO_SIDED|97.5|-0.72|-0.18|||mixed-effects model|||Month 1||-0.18|-0.72|< 0.001
91791770|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.85|-0.23|||mixed-effects model|||Month 2||-0.23|-0.85|< 0.001
91791771|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||Month 2||-0.65|-1.27|< 0.001
91791772|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-0.95|-0.21|||mixed-effects model|||Month 4||-0.21|-0.95|< 0.001
91791773|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-1.72|-0.99|||mixed-effects model|||Month 4||-0.99|-1.72|< 0.001
91791774|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-0.99|-0.23|||mixed-effects model|||Month 5||-0.23|-0.99|< 0.001
91791775|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-1.75|-1.0|||mixed-effects model|||Month 5||-1.00|-1.75|< 0.001
91791776|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.08|-0.3|||mixed-effects model|||Month 6||-0.30|-1.08|< 0.001
91713244|NCT01063855|183317770|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.1|17.2||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).||17.2|1.1|0.013
91713245|NCT01063855|183317771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.002|TWO_SIDED|95.0|1.204|2.619||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.619|1.204|0.002
91619877|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9669||||||Statistical significant level: 0.05|Chi-squared|||Comparson among Duration of Disease categories: \<3 Months, \>=3 Months and \<6 Months, and \>=6 Months||||0.9669
91619878|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0064||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||0.0064
91619879|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Satistical significant level: 0.05|Chi-squared|||Comparison among severity of infection subgroups: Mild, Moderate, and Severe.||||<0.0001
91659251|NCT00154102|183212942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.0038|TWO_SIDED|95.0|1.12|1.77|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.77|1.12|0.0038
91659252|NCT00154102|183212943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.069|||<|0.0001|TWO_SIDED|95.0|1.515|2.826|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||2.826|1.515|<0.0001
91713246|NCT01063855|183317772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.108|2.394||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.394|1.108|0.007
91791777|NCT01931670|183461150|SUPERIORITY||LS Mean of Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.67|-0.89|||mixed-effects model|||Month 6||-0.89|-1.67|< 0.001
91791778|NCT01931670|183461151|SUPERIORITY||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.007|TWO_SIDED|95.0|-7.25|-1.16|||ANCOVA|||Month 1||-1.16|-7.25|0.007
91659253|NCT00154102|183212944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.3475|TWO_SIDED|95.0|0.544|1.242|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.242|0.544|0.3475
91791779|NCT01931670|183461151|SUPERIORITY||Difference in LS Means|-7.55|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5|||ANCOVA|||Month 1||-4.50|-10.6|< 0.001
91791780|NCT01931670|183461151|SUPERIORITY||Difference in LS Means|-7.33|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.75|-3.91|||ANCOVA|||Month 3||-3.91|-10.75|< 0.001
91791781|NCT01931670|183461151|SUPERIORITY||Difference in LS Means|-15.43|STANDARD_ERROR_OF_MEAN|1.75|<|0.001|TWO_SIDED|95.0|-18.87|-11.99|||ANCOVA|||Month 3||-11.99|-18.87|< 0.001
91791782|NCT01931670|183461151|SUPERIORITY||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.81|-4.6|||ANCOVA|||Month 6||-4.60|-12.81|< 0.001
91619880|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History: Yes VS General Medical History: No||||<0.0001
91619881|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Present): Yes VS General Medical History (Present): No||||<0.0001
91791783|NCT01931670|183461151|SUPERIORITY||Difference in LS Means|-16.92|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-20.98|-12.86|||ANCOVA|||Month 6||-12.86|-20.98|< 0.001
91619882|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Past): Yes VS General Medical History (Past): No||||0.0006
91619883|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Kidney Disorder: Yes VS Kidney Disorder: No||||<0.0001
91619884|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Liver Disorder: Yes VS Liver Disorder: No||||<0.0001
91791784|NCT01931670|183461152|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|1.95||0.77|TWO_SIDED|95.0|-4.4|3.26|||ANCOVA|||Month 1||3.26|-4.40|0.77
91791785|NCT01931670|183461152|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|1.93||0.023|TWO_SIDED|95.0|-8.19|-0.61|||ANCOVA|||Month 1||-0.61|-8.19|0.023
91791786|NCT01931670|183461152|SUPERIORITY||Difference in LS Means|-2.74|STANDARD_ERROR_OF_MEAN|2.42||0.257|TWO_SIDED|95.0|-7.5|2.01|||ANCOVA|||Month 3||2.01|-7.50|0.257
91791787|NCT01931670|183461152|SUPERIORITY||Difference in LS Means|-10.69|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-15.37|-6.01|||ANCOVA|||Month 3||-6.01|-15.37|< 0.001
91791788|NCT01931670|183461152|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|2.91||0.315|TWO_SIDED|95.0|-8.66|2.8|||ANCOVA|||Month 6||2.80|-8.66|0.315
91619885|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||Statistical significant level: 0.05|Chi-squared|||Comparison among subgroups of Total Treatment Period of Tygacil: \<7 Days, 7 to 14 Days, and \>14 Days||||0.0153
91619886|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level 0.05|Fisher Exact|||Comparison among subgroups of Mean Daily Dose of Tygacil: \<50 mg, 50 to \<100 mg, 100 to \<200 mg, and \>=200 mg.||||<0.0001
91619887|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0376||||||Statistical significant level: 0.05|Chi-squared|||Past Medication and Therapy: Yes VS Past Medication and Therapy: No||||0.0376
91619888|NCT01072539|183132759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Concomitant Medications: Yes VS Concomitant Medications: No||||<0.0001
91619889|NCT03731364|183132775|SUPERIORITY|||||||0.276|||||||ANOVA|||||||0.276
91619890|NCT03731364|183132775|SUPERIORITY|||||||0.651|||||||ANOVA|||||||0.651
91619891|NCT03731364|183132775|SUPERIORITY|||||||0.556|||||||ANOVA|||||||0.556
91659254|NCT00154102|183212945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.6004|TWO_SIDED|95.0|0.67|1.26|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.26|0.67|0.6004
91619892|NCT03731364|183132776|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
91619893|NCT03731364|183132776|SUPERIORITY|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||||||0.649
91791789|NCT01931670|183461152|SUPERIORITY||Difference in LS Means|-14.1|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-19.64|-8.55|||ANCOVA|||Month 6||-8.55|-19.64|< 0.001
91619894|NCT03731364|183132776|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
91619895|NCT03731364|183132777|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
91619896|NCT03731364|183132777|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
91619897|NCT03731364|183132777|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic||Not estimable|Not estimable||||0
91619898|NCT03731364|183132778|SUPERIORITY|||||||0.306|||||||ANOVA|||||||0.306
91619899|NCT03731364|183132778|SUPERIORITY|||||||0.595|||||||ANOVA|||||||0.595
91619900|NCT03731364|183132778|SUPERIORITY|||||||0.242|||||||ANOVA|||||||0.242
91619901|NCT03655717|183132797|SUPERIORITY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.259|0.184||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.184|-0.259|0.94
91619902|NCT03655717|183132797|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.206||0.94|TWO_SIDED|95.0|-0.421|0.386||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.386|-0.421|0.94
91619903|NCT03655717|183132797|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.281||0.94|TWO_SIDED|95.0|-0.535|0.568||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.568|-0.535|0.94
91619904|NCT03655717|183132798|SUPERIORITY||Mean Difference (Final Values)|-0.163|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.384|0.057||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.057|-0.384|0.94
91659255|NCT00154102|183212947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.002|TWO_SIDED|95.0|1.45|6.27|||Cochran-Mantel-Haenszel|||||6.27|1.45|0.002
91791790|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.019|TWO_SIDED|95.0|-1.86|-0.17|||ANCOVA|||Month 1||-0.17|-1.86|0.019
91527710|NCT01976364|182930498|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91619905|NCT03655717|183132798|SUPERIORITY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.21||0.94|TWO_SIDED|95.0|-0.588|0.237||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.237|-0.588|0.94
91619906|NCT03655717|183132798|SUPERIORITY||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.276||0.94|TWO_SIDED|95.0|-0.354|0.728||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.728|-0.354|0.94
91659256|NCT04934722|183212969|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.24|2.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.34|0.24|
91619907|NCT01185249|183132799|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis-no difference in morning and evening weights on three consecutive days.|Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|3.09|<|0.001|TWO_SIDED|95.0|-0.51306|1.73806|||t-test, 1 sided|||Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.||1.73806|-0.51306|<.001
91619908|NCT01185249|183132799|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
91619909|NCT02193815|183132803|SUPERIORITY_OR_OTHER||Adjusted Mean Ratio|93.2|STANDARD_ERROR_OF_MEAN|0.075||0.3465|TWO_SIDED|95.0|80.43|107.99|||Mixed Models Analysis|||||107.99|80.43|0.3465
91619910|NCT02193815|183132804|SUPERIORITY_OR_OTHER||Adjusted Mean|165.88|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|143.12|192.25|||Mixed Models Analysis|||||192.25|143.12|<0.0001
91619911|NCT02193815|183132805|SUPERIORITY_OR_OTHER||Adjusted Mean|65.42|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|56.46|75.81|||Mixed Models Analysis|||||75.81|56.46|<0.0001
91619912|NCT02193815|183132806|SUPERIORITY_OR_OTHER||Adjusted Mean|93.04|STANDARD_ERROR_OF_MEAN|0.075||0.3349|TWO_SIDED|95.0|80.3|107.81|||Mixed Models Analysis|||||107.81|80.30|0.3349
91619913|NCT02193815|183132806|SUPERIORITY_OR_OTHER||Adjusted Mean|149.56|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|129.04|173.34|||Mixed Models Analysis|||||173.34|129.04|<0.0001
91619914|NCT02193815|183132806|SUPERIORITY_OR_OTHER||Adjusted Mean|106.51|STANDARD_ERROR_OF_MEAN|0.075||0.3991|TWO_SIDED|95.0|91.92|123.41|||Mixed Models Analysis|||||123.41|91.92|0.3991
91619915|NCT02193815|183132806|SUPERIORITY_OR_OTHER||Adjusted Mean|71.94|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|62.08|83.36|||Mixed Models Analysis|||||83.36|62.08|<0.0001
91659257|NCT04934722|183212970|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.3|6.01|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||6.01|0.30|
91659258|NCT04934722|183212971|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.5|3.63|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.63|0.50|
91659259|NCT04934722|183212973|OTHER||Hazard Ratio (HR)|3.15|||||TWO_SIDED|95.0|0.33|30.29|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||30.29|0.33|
91659260|NCT04934722|183212974|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.11|4.07|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||4.07|0.11|
91659261|NCT04934722|183212975|OTHER||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.73|2.9|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.90|0.73|
91619916|NCT02193815|183132807|SUPERIORITY_OR_OTHER||Adjusted Mean|96.04|STANDARD_ERROR_OF_MEAN|0.127||0.7529|TWO_SIDED|95.0|74.0|124.64|||Mixed Models Analysis|||||124.64|74.00|0.7529
91619917|NCT02193815|183132807|SUPERIORITY_OR_OTHER||Adjusted Mean|125.62|STANDARD_ERROR_OF_MEAN|0.147||0.1318|TWO_SIDED|95.0|92.96|169.75|||Mixed Models Analysis|||||169.75|92.96|0.1318
91619918|NCT02193815|183132807|SUPERIORITY_OR_OTHER||Adjusted Mean|103.35|STANDARD_ERROR_OF_MEAN|0.129||0.8009|TWO_SIDED|95.0|79.3|134.68|||Mixed Models Analysis|||||134.68|79.30|0.8009
91659262|NCT04934722|183212976|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||7.34|0.42|
91659263|NCT04934722|183212977|OTHER||Percent Difference|-5.5|||||TWO_SIDED|95.0|-12.6|0.0|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||0.0|-12.6|
91659264|NCT04934722|183212978|OTHER||Percent difference|-0.7|||||TWO_SIDED|95.0|-15.0|13.7|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||13.7|-15.0|
91659265|NCT04934722|183212979|OTHER||Percent difference|7.8|||||TWO_SIDED|95.0|-12.5|27.1|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||27.1|-12.5|
91659266|NCT06358820|183212983|SUPERIORITY|\>0.15 g/dL change in albumin from baseline to month 6 was anticipated.|Mean Difference (Final Values)|3.77|||<|0.0125|TWO_SIDED|95.0|3.15|4.39||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|Outcome Measure were assessed at baseline and every month during the 6-month study.||4.39|3.15|<0.0125
91659267|NCT06358820|183212984|SUPERIORITY|\>60 mg/L change in prealbumin from baseline to month 6.|Mean Difference (Net)|39.77||||0.0125|TWO_SIDED|95.0|26.66|56.87||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|||56.87|26.66|0.0125
91659268|NCT01124175|183212998|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|111.95|||||TWO_SIDED|90.0|101.84|123.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.06|101.84|
91659269|NCT01124175|183212999|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|103.61|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.39|103.61|
91659270|NCT01124175|183213000|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.67|||||TWO_SIDED|90.0|103.32|108.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.07|103.32|
91659271|NCT01124175|183213001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|101.22|110.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.93|101.22|
91659272|NCT01124175|183213002|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|103.07|||||TWO_SIDED|90.0|100.9|105.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.28|100.90|
91659273|NCT01124175|183213003|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.36|||||TWO_SIDED|90.0|100.41|104.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.34|100.41|
91713247|NCT01063855|183317773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.642|3.568||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.568|1.642|<0.001
91791791|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.433||0.028|TWO_SIDED|95.0|-1.8|-0.1|||ANCOVA|||Month 1||-0.10|-1.80|0.028
91791792|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.397||0.014|TWO_SIDED|95.0|-1.76|-0.2|||ANCOVA|||Month 2||-0.20|-1.76|0.014
91659274|NCT00834535|183213025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.83||||||90.0|93.98|108.17|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.17|93.98|
91659275|NCT00834535|183213026|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.1||||||90.0|92.14|100.22|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.22|92.14|
91659276|NCT00834535|183213027|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.57||||||90.0|92.8|100.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.49|92.8|
91791793|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.22|-0.65|||ANCOVA|||Month 2||-0.65|-2.22|< 0.001
91791794|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.432||0.121|TWO_SIDED|95.0|-1.52|0.18|||ANCOVA|||Month 3||0.18|-1.52|0.121
91791795|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.431||0.001|TWO_SIDED|95.0|-2.25|-0.56|||ANCOVA|||Month 3||-0.56|-2.25|0.001
91659277|NCT01045096|183213060|SUPERIORITY_OR_OTHER|||||||0.809||90.0|||||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.||||0.809
91713248|NCT01063855|183317774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||>|0.05|TWO_SIDED|95.0|0.897|1.965||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||1.965|0.897|>0.05
91791796|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-1.25|STANDARD_ERROR_OF_MEAN|0.561||0.026|TWO_SIDED|95.0|-2.35|-0.15|||ANCOVA|||Month 4||-0.15|-2.35|0.026
91527479|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|32.93||||0.074|TWO_SIDED|95.0|-3.19|69.06|||random coefficient regression|||In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA||69.06|-3.19|0.0740
91619919|NCT02193815|183132807|SUPERIORITY_OR_OTHER||Adjusted Mean|81.09|STANDARD_ERROR_OF_MEAN|0.124||0.1012|TWO_SIDED|95.0|62.94|104.47|||Mixed Models Analysis|||||104.47|62.94|0.1012
91619920|NCT00064350|183132812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Fisher Exact|||Compare the proportion of patients maintaining stable disease or objective response at 2 months after randomization between the two arms.||||0.005
91619921|NCT00064350|183132813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Log Rank|||Compare PFS between the Sorafenib arm and the placebo arm||||0.014
91619922|NCT00064350|183132814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||95.0|||||Log Rank|||Compare OS between the Sorafenib arm and the placebo arm||||0.12
91619923|NCT00115765|183132816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.011||95.0|1.06|1.52|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.52|1.06|0.011
91619924|NCT00115765|183132817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.005||95.0|1.11|1.83|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.83|1.11|0.005
91619925|NCT00115765|183132821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.738||95.0|0.6|2.05|||Regression, Logistic|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.05|0.60|0.738
91619926|NCT00115765|183132822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.257||95.0|0.77|2.62|||Regression, Cox|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.62|0.77|0.257
91659278|NCT01045096|183213061|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.2|||||TWO_SIDED|90.0|0.66|2.183|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.183|0.660|
91619927|NCT00115765|183132824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|1.04|1.77||||||||1.77|1.04|
91619928|NCT00115765|183132825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.91|1.71||||||||1.71|0.91|
91619929|NCT00115765|183132826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89||||||95.0|1.3|2.75||||||||2.75|1.30|
91619930|NCT00115765|183132827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||||95.0|0.67|1.54||||||||1.54|0.67|
91619931|NCT00115765|183132828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||||95.0|0.61|2.66||||||||2.66|0.61|
91619932|NCT00115765|183132829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||||95.0|0.28|1.67||||||||1.67|0.28|
91619933|NCT01683071|183132838|SUPERIORITY||LSMD|2.9||||0.9494|TWO_SIDED|95.0|-88.0|94.0|||ANCOVA|||||94|-88|0.9494
91619934|NCT01683071|183132838|SUPERIORITY||LSMD|-103.3||||0.0237|TWO_SIDED|95.0|-192.0|-14.0|||ANCOVA|||||-14|-192|0.0237
91659279|NCT01045096|183213061|SUPERIORITY_OR_OTHER||Dose proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.463|2.427|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.427|0.463|
91791797|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-1.48|STANDARD_ERROR_OF_MEAN|0.555||0.008|TWO_SIDED|95.0|-2.57|-0.39|||ANCOVA|||Month 4||-0.39|-2.57|0.008
91791798|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.327||0.027|TWO_SIDED|95.0|-1.37|-0.08|||ANCOVA|||Month 5||-0.08|-1.37|0.027
91791799|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-1.11|STANDARD_ERROR_OF_MEAN|0.327|<|0.001|TWO_SIDED|95.0|-1.75|-0.47|||ANCOVA|||Month 5||-0.47|-1.75|< 0.001
91619935|NCT01683071|183132838|SUPERIORITY||LSMD|-94.3||||0.0386|TWO_SIDED|95.0|-184.0|-5.0|||ANCOVA|||||-5|-184|0.0386
91619936|NCT01683071|183132838|SUPERIORITY||LSMD|-96.5|||<|0.0001|TWO_SIDED|95.0|-144.0|-49.0|||ANCOVA|||||-49|-144|<0.0001
91619937|NCT01683071|183132839|SUPERIORITY||Geometric LSM ratio|0.9||||0.6182|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.6182
91619938|NCT01683071|183132839|SUPERIORITY||Geometric LSM ratio|0.73||||0.1097|TWO_SIDED|95.0|0.5|1.1|||ANOVA|||||1.1|0.5|0.1097
91619939|NCT01683071|183132839|SUPERIORITY||Geometric LSM ratio|0.85||||0.4046|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.4046
91619940|NCT01683071|183132839|SUPERIORITY||Geometric LSM ratio|0.74||||0.0016|TWO_SIDED|95.0|0.6|0.9|||ANOVA|||||0.9|0.6|0.0016
91619941|NCT01968187|183132864|OTHER||LS Mean Difference|-6.7||||0.029|ONE_SIDED|90.0||-2.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effect and HPWSQ-R total score at baseline as covariate.||||-2.2||0.0290
91619942|NCT01968187|183132865|OTHER||LS Mean Difference|-0.8||||0.0233|ONE_SIDED|90.0||-0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and CGI-S score as a covariate.||||-0.3||0.0233
91619943|NCT01968187|183132866|OTHER||LS Mean Difference|-2.0||||0.1172|ONE_SIDED|90.0||0.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score at baseline as a covariate.||HPWSQ-R Domain score: Behavior||0.2||0.1172
91619944|NCT01968187|183132866|OTHER||LS Mean Difference|-1.6||||0.1436|ONE_SIDED|90.0||0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Drive||0.3||0.1436
91619945|NCT01968187|183132866|OTHER||LS Mean Difference|-1.5||||0.0248|ONE_SIDED|90.0||-0.5|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Severity||-0.5||0.0248
91619946|NCT01968187|183132867|OTHER||LS mean difference|-6.2||||0.0047|ONE_SIDED|90.0||-3.3|||ANCOVA|From ANCOVA model with treatment and site as fixed effects and CY-BOCS total score at baseline as a covariate.||||-3.3||0.0047
91619947|NCT01968187|183132868|OTHER||LS mean difference|-4.4||||0.0132|ONE_SIDED|90.0||-1.9|||ANCOVA|Compared using ANCOVA model with treatment and site as fixed effects and Food Domain Score of Reiss Profile at baseline as a covariate.||||-1.9||0.0132
91659280|NCT01045096|183213061|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|0.88|||||TWO_SIDED|90.0|0.493|1.579|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||1.579|0.493|
91659281|NCT01045096|183213062|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.13|||||TWO_SIDED|90.0|0.693|1.848|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.848|0.693|
91619948|NCT03675737|183132920|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.7|0.87||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.87|0.70|<0.0001
91619949|NCT03675737|183132921|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.84||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.84|0.65|<0.0001
91619950|NCT03675737|183132922|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.79|0.53|<0.0001
91619951|NCT03675737|183132923|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.67|0.85||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.85|0.67|<0.0001
91619952|NCT03675737|183132924|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.63|0.82||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.82|0.63|<0.0001
91619953|NCT03675737|183132925|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.76|0.51|<0.0001
91619954|NCT03675737|183132926|SUPERIORITY||Difference in Percentage|9.3||||9e-05|TWO_SIDED|95.0|4.4|14.1||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||14.1|4.4|0.00009
91619955|NCT03675737|183132927|SUPERIORITY||Difference in Percentage|9.5||||0.00041|TWO_SIDED|95.0|3.9|15.0||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||15.0|3.9|0.00041
91659282|NCT01045096|183213062|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.15|||||TWO_SIDED|90.0|0.584|2.276|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||2.276|0.584|
91659283|NCT01045096|183213062|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.02|||||TWO_SIDED|90.0|0.632|1.642|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.642|0.632|
91659284|NCT01045096|183213063|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.692|1.636|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.636|0.692|
91659285|NCT01045096|183213063|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.26|||||TWO_SIDED|90.0|0.691|2.314|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||2.314|0.691|
91659286|NCT01045096|183213063|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.19|||||TWO_SIDED|95.0|0.777|1.817|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.817|0.777|
91659287|NCT00909610|183213084|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.3|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||111|92.3|
91659288|NCT00909610|183213085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|106.0||||||90.0|101.0|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|101|
91659289|NCT00909610|183213086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|101.0||||||90.0|91.9|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|91.9|
91659290|NCT00909610|183213087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|105.0||||||90.0|100.0|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|100|
91659291|NCT00909610|183213088|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.5|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.5|
91659292|NCT00909610|183213089|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117|103|
91659293|NCT00909610|183213090|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
91659294|NCT00909610|183213091|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
91659295|NCT01032083|183213127|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|-1.54||||0.36|TWO_SIDED|95.0|-4.91|1.8|||Regression, Linear|||||1.80|-4.91|0.36
91659296|NCT01032083|183213128|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-9.0|14.0|||Regression, Linear|||||14|-9|0.68
91791800|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.391||0.143|TWO_SIDED|95.0|-1.34|0.2|||ANCOVA|||Month 6||0.20|-1.34|0.143
91619956|NCT03675737|183132928|SUPERIORITY||Difference in Percentage|17.5||||2e-05|TWO_SIDED|95.0|9.3|25.5||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||25.5|9.3|0.00002
91619957|NCT02108600|183132954|OTHER|||||||0.033|TWO_SIDED|95.0|||||Fisher Exact|||||||0.033
91659297|NCT03612960|183213146|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.14|0.43|||t-test, 2 sided||||The mean percent change in BOLD signal used for this t-test was extracted from a brain cluster with significant group differences in changes in activation over time (voxel p\<.05, cluster p\<.05) identified using a whole-brain, voxel-wise two-way mixed effect ANOVA with FSL software.|0.43|0.14|<.001
91659298|NCT03612960|183213147|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|4.33||0.063|TWO_SIDED|95.0|-17.24|0.48|||t-test, 2 sided|||||0.48|-17.24|.063
91659299|NCT03612960|183213148|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|9.86||0.89|TWO_SIDED|95.0|-21.57|18.82|||t-test, 2 sided|||||18.82|-21.57|0.890
91659300|NCT00834249|183213149|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
91659301|NCT00834249|183213150|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
91659302|NCT00834249|183213151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.71||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
91659303|NCT00834249|183213152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|109.61||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
91659304|NCT00834249|183213153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.85||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational puposes only.|||||
91659305|NCT00834249|183213154|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.38||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
91659306|NCT00834743|183213155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.49||||||90.0|90.65|109.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.18|90.65|
91659307|NCT00834743|183213156|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|91.44|107.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.19|91.44|
91659308|NCT00834743|183213157|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|90.57|108.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.32|90.57|
91659309|NCT01643707|183213173|SUPERIORITY|A chi-square test was performed to determine a difference between Phase 1 and Phase 2.|||||<|1e-05|||||||Chi-squared|||||||<0.00001
91659310|NCT01643707|183213174|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91659311|NCT01643707|183213175|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001||||||This endpoint was covered in primary objective 2, so this analysis is the same as previously reported.|Chi-squared||||See Primary Objectives for additional details.|||<0.0001
91659312|NCT04112823|183213180|SUPERIORITY||Risk Ratio (RR)|7.0|||||TWO_SIDED|95.0|-6.0|20.0||||||||20|-6|
91659313|NCT04112823|183213181|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-8.0|16.0||||||||16|-8|
91659314|NCT04112823|183213182|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|-8.0|14.0||||||||14|-8|
91659315|NCT04112823|183213184|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||||1.2|-0.3|
91659316|NCT04112823|183213185|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-9.0|18.0||||||||18|-9|
91659317|NCT03603314|183213194|SUPERIORITY|||||||0.3419|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3419
91659318|NCT03603314|183213194|SUPERIORITY|||||||0.5181|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5181
91659319|NCT03603314|183213195|SUPERIORITY|||||||0.3666|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3666
91713249|NCT01063855|183317775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.425|3.423||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.423|1.425|<0.001
91619958|NCT01295580|183132959|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)~Alpha inflation was controlled using pre-planned stepwise hypotheses testing (1) WOMAC Pain over 18 weeks then (2) over 26 weeks, (3) WOMAC Physical Function over 18 weeks then (4) over 26 weeks, (5) Subject Global Assessment over 18 weeks then (6) over 26 weeks, (7) WOMAC Knee Stiffness over 18 weeks then (8) over 26 weeks."|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.58|0.39||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the first step WOMAC pain over 18 week pain subscale primary analyses.||The second step is to test Durolane WOMAC pain non-inferior to Artz WOMAC pain over 26 weeks.||"Primary Hypothesis:~Ho: μDUR\[18\] - μArtz\[18\] ≥ +1.6 units Ha: μDUR\[18\] - μArtz\[18\] \< +1.6 units~Power Calculations:~Assume the over 18 weeks difference is 0mm, SD 20mm (5 on the Likert scale), 90% power, 2-sided test alpha 5%, and a 8mm non-inferiority margin (1.6 on the Likert scale), the sample size required is 132 subjects per group adjusted to 175 to hold power constant due to loss to follow-up and dropout."||0.39|-0.58|
91659320|NCT03603314|183213195|SUPERIORITY|||||||0.5776|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5776
91659321|NCT03603314|183213196|SUPERIORITY|||||||0.4094|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4094
91659322|NCT03603314|183213196|SUPERIORITY|||||||0.4602|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4602
91659323|NCT03603314|183213197|SUPERIORITY|||||||0.1269|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1269
91659324|NCT03603314|183213197|SUPERIORITY|||||||0.2257|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.2257
91659325|NCT03603314|183213198|SUPERIORITY|||||||0.3121|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3121
91619959|NCT01295580|183132960|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.56|0.37||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first pain over 18 weeks then pain over 26 weeks. This section reports the over 26 week pain subscale results.||The third ordered test is Durolane WOMAC physical function subscale non-inferior to Artz WOMAC physical function subscale over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +1.6 units Ha: μDUR\[26\] - μArtz\[26\] \< +1.6 units||0.37|-0.56|
91619960|NCT01295580|183132961|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.81|0.51||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week physical function results.||The fourth step is to test Durolane WOMAC physical function non-inferior to Artz physical function over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +5.44 units Ha: μDUR\[18\] - μArtz\[18\] \< +5.44 units||0.51|-1.81|
91659326|NCT03603314|183213198|SUPERIORITY|||||||0.4965|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4965
91659327|NCT03603314|183213199|SUPERIORITY|||||||0.0976|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.0976
91659328|NCT03603314|183213199|SUPERIORITY|||||||0.1762|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1762
91659329|NCT01382719|183213212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0215|STANDARD_DEVIATION|2.9|<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.0|0.0|<0.05
91619961|NCT01295580|183132962|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.69|0.53||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week physical function subscale results.||The fifth step is to test Durolane subject global assessment non-inferior to Artz global assessment over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +5.44 units Ha: μDUR\[26\] - μArtz\[26\] \< +5.44 units||0.53|-1.69|
91619962|NCT01295580|183132963|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.15|0.45||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week subject global assessment results.||The sixth step is to test Durolane subject global assessment non-inferior to Artz subject global assessment over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.45|-0.15|
91619963|NCT01295580|183132964|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.16|0.43||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week subject global assessment results.||The seventh step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 18 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.43|-0.16|
91619964|NCT01295580|183132965|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.33|0.05||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week knee stiffness subscale results.||The eight and last step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +0.64 units Ha: μDUR\[18\] - μArtz\[18\] \< +0.64 units||0.05|-0.33|
91619965|NCT01295580|183132966|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of 0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.33|0.03||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week knee stiffness subscale results.||This is the eighth and last pre-planned hypothesis test.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +0.64 units Ha: μDUR\[26\] - μArtz\[26\] \< +0.64 units||0.03|-0.33|
91619966|NCT03943953|183132968|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.018|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.018
91619967|NCT03943953|183132970|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.001|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.001
91619968|NCT03943953|183132972|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.006|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.006
91619969|NCT03943953|183132974|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.035|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.035
91619970|NCT03943953|183132976|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.39|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.39
91619971|NCT01940510|183132989|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|26.8|||||TWO_SIDED|90.0|23.8|30.1|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.||30.1|23.8|
91619972|NCT01940510|183132990|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|48.6|||||TWO_SIDED|90.0|43.5|54.3|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||54.3|43.5|
91619973|NCT01940510|183132991|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|179.0|||||TWO_SIDED|90.0|158.0|202.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||202|158|
91619974|NCT01940510|183132992|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|220.0|||||TWO_SIDED|90.0|190.0|255.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||255|190|
91713250|NCT02492802|183317776|OTHER|||||||0.77|||||||The Wald Type III test|||||||0.77
91713251|NCT01165307|183317777|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91659330|NCT01382719|183213212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|STANDARD_DEVIATION|0.0012|<|0.05|TWO_SIDED|95.0|0.0|0.06|||Van Elteren|||||0.06|0.00|<0.05
91619975|NCT05025787|183133006|SUPERIORITY||model treatment coefficient|-1.774|STANDARD_DEVIATION|0.639||0.006|TWO_SIDED|95.0|-3.033|-0.514||A 95% confidence interval for the treatment coefficient in the linear mixed-effect model was (-3.033, -0.514), where the reference level was the active treatment.|Mixed Models Analysis|||"Null hypothesis is that there was no difference in mean WOMAC-A pain between CNTX-6970 and Placebo. Linear mixed-effect models were used with block, period, sex, age, and KL-grade as covariates and treatment group as factor, with random effects for sites and subjects nested within sites. The test was performed with significance level of 0.05 (two-sided).~Power was computed for effect sizes ranging from 0.25 to 0.50 using Monte Carlo simulation, and exceeded 80%."||-0.514|-3.033|.006
91619976|NCT03471767|183133017|SUPERIORITY|Multilevel modeling (MLM) was used to model daily reports of cigarettes smoked as a function of week, treatment (AXS-05 vs. bupropion), and the interaction between week and treatment. The contrast between the two treatment groups in change in smoking intensity from baseline to week 3 was estimated within the context of the model.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.54||0.05|TWO_SIDED|95.0|-2.75|-0.65||This was not adjusted for multiple comparisons, because the primary hypothesis was established a-priori.|t-test, 2 sided|||||-0.65|-2.75|0.05
91619977|NCT03471767|183133023|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
91619978|NCT05600309|183133024|OTHER||Hazard Ratio (HR)|0.94||||0.3914|TWO_SIDED|95.0|0.59|1.5||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.59|0.3914
91619979|NCT05600309|183133025|OTHER||Hazard Ratio (HR)|1.23||||0.8091|TWO_SIDED|95.0|0.78|1.92||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.92|0.78|0.8091
91619980|NCT05600309|183133026|OTHER||Difference in percentage|6.0||||0.0502|TWO_SIDED|95.0|-2.3|16.3||One-sided nominal p-value for testing.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|||16.3|-2.3|0.0502
91619981|NCT00807846|183133030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.274|TWO_SIDED|90.0|-0.56|2.76|||ANCOVA|||The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.||2.76|-0.56|0.274
91619982|NCT00807846|183133031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.088||||0.148|TWO_SIDED|95.0|-0.39|2.57|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||2.57|-0.39|0.148
91659331|NCT01382719|183213213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0496|||<|0.05|||||||ANCOVA|||||||<0.05
91659332|NCT01382719|183213214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0079|||<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.00|0.00|<0.05
91659333|NCT01382719|183213215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|||<|0.05|||||||Van Elteren|||||||<0.05
91659334|NCT01382719|183213216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0013|||<|0.05|||||||Van Elteren|||||||<0.05
91659335|NCT01382719|183213217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1161|||<|0.05|||||||Van Elteren|||||||<0.05
91659336|NCT01382719|183213218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0133|||<|0.05|||||||ANCOVA|||||||<0.05
91659337|NCT00064753|183213221|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.99||||0.93|TWO_SIDED|95.0|0.84|1.17||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.17|0.84|0.93
91659338|NCT00064753|183213222|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.15||||0.19|TWO_SIDED|95.0|0.93|1.43||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.43|0.93|0.19
91659339|NCT00064753|183213223|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.67|TWO_SIDED|95.0|0.86|1.26||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.26|0.86|0.67
91659340|NCT00064753|183213224|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.61|TWO_SIDED|95.0|0.8|1.45||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.45|0.80|0.61
91659341|NCT00064753|183213225|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.12||||0.64|TWO_SIDED|95.0|0.69|1.81||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.81|0.69|0.64
91659342|NCT00064753|183213226|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.66|TWO_SIDED|95.0|0.3|2.15||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||2.15|0.30|0.66
91713252|NCT01165307|183317778|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 Physical Scale.||||0.82
91713253|NCT01165307|183317778|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 mental scale.||||0.11
91659343|NCT00064753|183213227|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.28|TWO_SIDED|95.0|0.62|1.15|||Regression, Cox|||||1.15|0.62|0.28
91659344|NCT00064753|183213228|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.7|TWO_SIDED|95.0|0.73|1.23|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.23|0.73|0.70
91659345|NCT00064753|183213229|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.49|TWO_SIDED|95.0|0.79|1.65|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.65|0.79|0.49
91659346|NCT00064753|183213230|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.78|TWO_SIDED|95.0|0.46|2.8|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.80|0.46|0.78
91659347|NCT00064753|183213231|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.5|TWO_SIDED|95.0|0.15|2.57|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.57|0.15|0.50
91659348|NCT00064753|183213232|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.6|TWO_SIDED|95.0|0.48|3.5|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||3.50|0.48|0.60
91659349|NCT00624065|183213306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.8822||95.0|0.63|1.49|||Regression, Logistic|||||1.49|0.63|0.8822
91659350|NCT01387022|183213308|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91659351|NCT01387022|183213309|SUPERIORITY_OR_OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
91527711|NCT01976364|182930498|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
91659352|NCT01387022|183213311|SUPERIORITY_OR_OTHER|||||||0.267|||||||Fisher Exact|||||||0.267
91659353|NCT01536405|183213321|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease \>= the prespecified criterion of 10 percentage points|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|1.8|6.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||6.8|1.8|<0.001
91659354|NCT01536405|183213321|SUPERIORITY_OR_OTHER||Response rate|97.3|||<|0.001|TWO_SIDED|95.0|95.6|98.4|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>76%||98.4|95.6|<0.001
91659355|NCT01536405|183213322|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-2.2||||0.003|TWO_SIDED|95.0|-4.0|-0.6|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||-0.6|-4.0|0.003
91659356|NCT01536405|183213322|SUPERIORITY_OR_OTHER||Response rate|96.7|||<|0.001|TWO_SIDED|95.0|94.9|97.9|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||97.9|94.9|<0.001
91659357|NCT01536405|183213323|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|-0.7|2.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||2.8|-0.7|<0.001
91659358|NCT01536405|183213323|SUPERIORITY_OR_OTHER||Response rate|98.2|||<|0.001|TWO_SIDED|95.0|96.8|99.1|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.1|96.8|<0.001
91659359|NCT01536405|183213324|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.8|0.7|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||0.7|-1.8|<0.001
91659360|NCT01536405|183213324|SUPERIORITY_OR_OTHER||Response rate|98.8|||<|0.001|TWO_SIDED|95.0|97.6|99.5|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.5|97.6|<0.001
91659361|NCT01536405|183213325|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.3|1.1|<0.001
91659362|NCT01536405|183213326|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.0|0.8|<0.001
91713254|NCT01165307|183317779|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91713255|NCT01165307|183317780|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91713256|NCT01165307|183317781|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91713257|NCT01165307|183317782|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91713258|NCT01165307|183317783|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91713259|NCT01165307|183317787|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91713260|NCT02683239|183317866|SUPERIORITY||Least Squares Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.221|=|0.001|TWO_SIDED|95.0|-1.159|-0.293|||Mixed Models Analysis|||||-0.293|-1.159|= 0.0010
91713261|NCT02683239|183317866|SUPERIORITY||Least Squares Mean|-1.22|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.646|-0.793|||Mixed Models Analysis|||||-0.793|-1.646|< 0.0001
91713262|NCT02683239|183317866|SUPERIORITY||Least Squares Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.664|-0.793|||Mixed Models Analysis|||||-0.793|-1.664|< 0.0001
91713263|NCT02683239|183317866|SUPERIORITY||Least Squares Mean|-1.04|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.477|-0.606|||Mixed Models Analysis|||||-0.606|-1.477|< 0.0001
91713264|NCT02683239|183317867|SUPERIORITY||Least Squares Mean|-0.74|STANDARD_ERROR_OF_MEAN|0.218|=|0.0007|TWO_SIDED|95.0|-1.163|-0.309|||Mixed Models Analysis|||||-0.309|-1.163|= 0.0007
91659363|NCT01536405|183213327|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
91659364|NCT01536405|183213328|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
91659365|NCT01536405|183213329|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-1.0|1.3|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||1.3|-1.0|<0.001
91659366|NCT01844375|183213338|EQUIVALENCE|equivalence analysis||||||0.75|||||||Kruskal-Wallis|||||||0.75
91659367|NCT02729714|183213395|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91659368|NCT02729714|183213396|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
91659369|NCT02729714|183213397|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
91659370|NCT02729714|183213398|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91659371|NCT02729714|183213399|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91659372|NCT02729714|183213400|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
91659373|NCT02729714|183213401|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91659374|NCT05093205|183213437|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|122.48|||||TWO_SIDED|90.0|106.96|140.25|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||140.25|106.96|
91659375|NCT05093205|183213437|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|143.83|||||TWO_SIDED|90.0|122.64|168.68|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||168.68|122.64|
91659376|NCT05093205|183213438|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|104.46|||||TWO_SIDED|90.0|92.56|117.89|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||117.89|92.56|
91659377|NCT05093205|183213438|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|92.77|||||TWO_SIDED|90.0|81.05|106.19|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||106.19|81.05|
91659378|NCT03897088|183213494|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
91659379|NCT03897088|183213503|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
91659380|NCT03897088|183213504|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
91659381|NCT03897088|183213505|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
91659382|NCT03897088|183213506|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
91659383|NCT03897088|183213507|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
91659384|NCT03897088|183213508|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
91659385|NCT03897088|183213509|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
91659386|NCT03897088|183213510|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||||||<0.00001
91659387|NCT03897088|183213511|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-75||||<0.00001
91659388|NCT03897088|183213511|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-90||||<0.00001
91659389|NCT03897088|183213511|SUPERIORITY|||||||4e-05|||||||Cochran-Mantel-Haenszel|||PASI-100||||0.00004
91659390|NCT03897088|183213512|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
91659391|NCT03897088|183213513|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
91659392|NCT03897088|183213514|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
91659393|NCT03897088|183213515|SUPERIORITY||||||<|1e-05||||||Week 16|Cochran-Mantel-Haenszel|||||||<0.00001
91659394|NCT03897088|183213516|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
91659395|NCT03897088|183213517|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
91659396|NCT01811953|183213531|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.55|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.531|105.653|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.653|99.531|<0.0001
91659397|NCT01811953|183213531|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.88|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.879|103.059|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.059|94.879|<0.0001
91713265|NCT02683239|183317867|SUPERIORITY||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.218|<|0.0001|TWO_SIDED|95.0|-1.624|-0.768|||Mixed Models Analysis|||||-0.768|-1.624|< 0.0001
91713266|NCT02683239|183317867|SUPERIORITY||Least Squares Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.698|-0.822|||Mixed Models Analysis|||||-0.822|-1.698|< 0.0001
91619983|NCT00807846|183133032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.837||||0.027|TWO_SIDED|95.0|0.21|3.46|||ANCOVA|||"For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05."||3.46|0.21|0.027
91619984|NCT00807846|183133033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.207||||0.106|TWO_SIDED|95.0|-2.67|0.26|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||0.26|-2.67|0.106
91619985|NCT00807846|183133034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.776|TWO_SIDED|95.0|-1.3|1.74|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.74|-1.30|0.776
91619986|NCT00807846|183133035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.815|TWO_SIDED|95.0|-1.69|1.33|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.33|-1.69|0.815
91619987|NCT00807846|183133036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.033||||0.303|TWO_SIDED|95.0|-2.76|8.82|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||8.82|-2.76|0.303
91619988|NCT00807846|183133037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061||||0.392|TWO_SIDED|95.0|-0.202|0.079|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.079|-0.202|0.392
91619989|NCT00807846|183133038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402||||0.897|TWO_SIDED|95.0|-6.5|5.69|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||5.69|-6.50|0.897
91619990|NCT00807846|183133039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.102||||0.2|TWO_SIDED|95.0|-0.257|0.053|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.053|-0.257|0.200
91619991|NCT02491073|183133061|OTHER||geometric mean ratio|1.05||||1.05|TWO_SIDED|90.0|0.98|1.09|||geometric mean ration||The parameter dispersion type:Geometric coefficient of variation Dispersion Value: FT4: 0.220|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.09|0.98|1.05
91619992|NCT02491073|183133061|OTHER||Geometric Mean Ratio|1.15|||||TWO_SIDED|90.0|1.09|1.22|||Geometric Mean Ratio||parameter dispersion type: Geometric Coefficient of Variation Dispersion Value : FT3: 0.178|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.22|1.09|
91619993|NCT02491073|183133062|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|1.01|1.03|||||Parameter dispersion type: geometric coefficient of variation dispersion value 0.024|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.01|
91713267|NCT02683239|183317867|SUPERIORITY||Least Squares Mean|-1.13|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.564|-0.695|||Mixed Models Analysis|||||-0.695|-1.564|< 0.0001
91713268|NCT02683239|183317868|SUPERIORITY||Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.09|=|0.023|TWO_SIDED|95.0|-0.38|-0.028|||Mixed Models Analysis|||||-0.028|-0.380|= 0.0230
91713269|NCT02683239|183317868|SUPERIORITY||Least Squares Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.088|=|0.0025|TWO_SIDED|95.0|-0.437|-0.093|||Mixed Models Analysis|||||-0.093|-0.437|= 0.0025
91713270|NCT02683239|183317868|SUPERIORITY||Least Squares Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.09|=|0.0003|TWO_SIDED|95.0|-0.496|-0.145|||Mixed Models Analysis|||||-0.145|-0.496|= 0.0003
91713271|NCT02683239|183317868|SUPERIORITY||Least Squares Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.089|=|0.001|TWO_SIDED|95.0|-0.466|-0.118|||Mixed Models Analysis|||||-0.118|-0.466|= 0.0010
91659398|NCT01811953|183213531|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.0|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.728|109.386|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.386|102.728|<0.0001
91659399|NCT01811953|183213532|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|96.13|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.25|101.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.26|91.25|<0.0001
91659400|NCT01811953|183213532|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.34|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.56|106.62|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||106.62|92.56|<0.0001
91659401|NCT01811953|183213532|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean difference|100.81|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.74|106.14|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||106.14|95.74|<0.0001
91659402|NCT01811953|183213533|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.33|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.315|105.43|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.430|99.315|<0.0001
91659403|NCT01811953|183213533|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.82|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.784|103.037|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.037|94.784|<0.0001
91659404|NCT01811953|183213533|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|105.98|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.73|109.329|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.329|102.730|<0.0001
91659405|NCT01811953|183213534|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.12|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|96.255|108.351|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||108.351|96.255|<0.0001
91659406|NCT01811953|183213534|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.52|STANDARD_ERROR_OF_MEAN|1.063||0.0082|TWO_SIDED|90.0|95.863|118.353|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||118.353|95.863|0.0082
91659407|NCT01811953|183213534|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|104.352|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.152|110.224|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||110.224|99.152|<0.0001
91713272|NCT01718483|183317897|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.7|-1.01|||Mixed Models Repeated Measures Analysis|||||-1.01|-1.70|<0.001
91713273|NCT01718483|183317898|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91659408|NCT01811953|183213535|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.87|STANDARD_ERROR_OF_MEAN|1.038||0.0001|TWO_SIDED|90.0|88.931|101.21|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.210|88.931|0.0001
91713274|NCT01718483|183317899|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91713275|NCT01718483|183317900|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.54|||Mixed Models Repeated Measures Analysis|||||-5.54|-7.17|<0.001
91619994|NCT02491073|183133062|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|1.03|1.04|||||parameter dispersion value - geometric coefficient of variation dispersion value - 0.020|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.03|
91713276|NCT01718483|183317901|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-7.4|||<|0.001|TWO_SIDED|95.0|-8.93|-5.88|||Mixed Models Repeated Measures Analysis|||||-5.88|-8.93|<0.001
91713277|NCT01718483|183317902|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.199|||<|0.001|TWO_SIDED|95.0|-0.31|-0.088|||ANCOVA|||||-0.088|-0.310|<0.001
91713278|NCT01718483|183317903|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.211|||<|0.001|TWO_SIDED|95.0|-0.33|-0.092|||ANCOVA|||||-0.092|-0.330|<0.001
91713279|NCT01718483|183317904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02||||0.308|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||||0.02|-0.07|0.308
91619995|NCT02491073|183133062|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.05|1.06|||||parameter dispersion type - geometric coefficient variation dispersion value - 0.021|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.06|1.05|
91619996|NCT02491073|183133062|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type -geometric coefficient of variation dispersion value - 0.040|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|0.99|
91619997|NCT02491073|183133062|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geotmetric mean ratio|1.02|||||TWO_SIDED|90.0|1.0|1.03|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.00|
91619998|NCT02491073|183133062|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.03|||||TWO_SIDED|90.0|1.02|1.04|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.02|
91713280|NCT01718483|183317905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
91713281|NCT01718483|183317906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.77|||<|0.001|TWO_SIDED|95.0|-2.24|-1.3||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.30|-2.24|<0.001
91713282|NCT01718483|183317907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.65|||<|0.001|TWO_SIDED|95.0|0.72|2.57||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.57|0.72|<0.001
91713283|NCT01718483|183317907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.19|||<|0.001|TWO_SIDED|95.0|-4.98|-3.39||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-3.39|-4.98|<0.001
91713284|NCT01718483|183317907|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|||<|0.001|TWO_SIDED|95.0|-5.49|-3.91||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.91|-5.49|<0.001
91713285|NCT01718483|183317908|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-10.32|||<|0.001|TWO_SIDED|95.0|-12.43|-8.21||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-8.21|-12.43|<0.001
91713286|NCT01718483|183317909|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.31||||0.706|TWO_SIDED|95.0|-1.93|1.31||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||1.31|-1.93|0.706
91713287|NCT03442088|183317929|OTHER||Mean Difference (Final Values)|-0.272||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91713288|NCT03442088|183317930|OTHER||Mean Difference (Final Values)|95.98||||0.934|TWO_SIDED|95.0|-2324.0|2516.0|||t-test, 2 sided|||||2516|-2324|0.934
91713289|NCT03442088|183317931|OTHER||Mean Difference (Final Values)|-0.6878||||0.1632|TWO_SIDED|95.0|-1.685|0.3097|||t-test, 2 sided|||||0.3097|-1.685|0.1632
91713290|NCT03442088|183317932|OTHER||Mean Difference (Final Values)|-2.344||||0.1063|TWO_SIDED|95.0|-5.248|0.5992|||t-test, 2 sided|||||0.5992|-5.248|0.1063
91713291|NCT03442088|183317933|OTHER||Mean Difference (Final Values)|3.24||||0.5611|TWO_SIDED|95.0|-8.333|14.81|||t-test, 2 sided|||||14.81|-8.333|0.5611
91713292|NCT02541422|183317938|SUPERIORITY|||||||0.45||||||p-value calculated for the total hangover scale|Wilcoxon (Mann-Whitney)|||||||0.45
91659409|NCT01811953|183213535|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|97.97|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|92.339|103.935|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.935|92.339|<0.0001
91659410|NCT01811953|183213535|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.95|STANDARD_ERROR_OF_MEAN|1.034|<|0.0001|TWO_SIDED|90.0|97.166|109.082|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.082|97.166|<0.0001
91659411|NCT01811953|183213536|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.89|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|89.8|100.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||100.26|89.80|<0.0001
91713293|NCT02541422|183317938|SUPERIORITY|||||||0.93||||||p value calculated for symptom of headache|Wilcoxon (Mann-Whitney)|||||||0.93
91713294|NCT02541422|183317938|SUPERIORITY|||||||0.11||||||p value calculated for symptom of nausea|Wilcoxon (Mann-Whitney)|||||||0.11
91527712|NCT01976364|182930499|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|0.0|
91619999|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
91620000|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
91620001|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
91620002|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator.|1.02|0.99|
91620003|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Slope|1.01|||||TWO_SIDED|90.0|1.0|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.033|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|1.00|
91620004|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.036|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.99|
91659412|NCT01811953|183213536|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.31|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.14|107.03|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||107.03|92.14|<0.0001
91713295|NCT02541422|183317938|SUPERIORITY|||||||0.72||||||p value calculated for symptom of weakness|Wilcoxon (Mann-Whitney)|||||||0.72
91713296|NCT02326272|183317986|SUPERIORITY||Odds Ratio (OR)|33.405|||<|0.0001|TWO_SIDED|97.5|9.965|111.983||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||111.983|9.965|<0.0001
91620005|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.047|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
91620006|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.043|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
91620007|NCT02491073|183133063|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.048|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.00|0.97|
91620008|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.148|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.16|1.06|
91620009|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.07|1.2|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.202|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.20|1.07|
91620010|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.04|1.18|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.18|1.04|
91620011|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.99|1.1|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.179|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.10|0.99|
91620012|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.21|||||TWO_SIDED|90.0|1.15|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.178|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.15|
91620013|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.42|||||TWO_SIDED|90.0|1.33|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.224|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.33|
91659413|NCT01811953|183213536|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|100.74|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.77|105.96|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||105.96|95.77|<0.0001
91691902|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5757||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.5757
91620014|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.12|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.12|
91692404|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|1.3|8.3||||||2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||8.3|1.3|
91713297|NCT02326272|183317986|SUPERIORITY||Estimated difference in responder rate|69.7|||||TWO_SIDED|95.0|57.12|82.36|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||82.36|57.12|
91713298|NCT02326272|183317986|SUPERIORITY||Odds Ratio (OR)|36.212|||<|0.0001|TWO_SIDED|97.5|10.686|122.713||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||122.713|10.686|<0.0001
91620015|NCT02491073|183133064|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.11|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.215|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.11|
91620016|NCT02491073|183133065|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
91620017|NCT02491073|183133065|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
91620018|NCT02491073|183133065|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
91620019|NCT03977727|183133066|SUPERIORITY||Mean Difference (Final Values)|27.35||||0.008|TWO_SIDED|95.0|7.88|48.4|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||48.4|7.88|.008
91620020|NCT03977727|183133067|SUPERIORITY||Mean Difference (Final Values)|15.22||||0.136|TWO_SIDED|95.0|-5.42|39.46|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||39.46|-5.42|.136
91620021|NCT03977727|183133068|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.029|TWO_SIDED|95.0|0.05|0.73|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.73|.05|.029
91620022|NCT03977727|183133069|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.016|TWO_SIDED|95.0|-2.84|-0.31|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||-0.31|-2.84|.016
91620023|NCT03977727|183133070|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.045|TWO_SIDED|95.0|0.04|2.32|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||2.32|.04|.045
91620024|NCT03977727|183133073|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.59|0.16|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.16|-.59|.303
91620025|NCT03977727|183133074|SUPERIORITY||Mean Difference (Final Values)|-1.18||||0.968|TWO_SIDED|95.0|-10.32|9.99|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||9.99|-10.32|.968
91791801|NCT01931670|183461153|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.385||0.019|TWO_SIDED|95.0|-1.67|-0.15|||ANCOVA|||Month 6||-0.15|-1.67|0.019
91620026|NCT03977727|183133075|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.059|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||0|-.13|.059
91620027|NCT01419665|183133086|EQUIVALENCE|The equivalence margin of + or - 12% was determined considering the variability of the point estimate of the add-on effect by taking a value lower than the lower boundary of the 95% CI for Rituximab+chemotherapy versus chemotherapy obtained from historical data.|difference in overall response rate|-0.4|||||TWO_SIDED|95.0|-5.94|5.14|||Binomial approximation|||||5.14|-5.94|
91620028|NCT01419665|183133089|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.97|1.76|||Regression, Cox|||||1.76|0.97|
91620029|NCT01419665|183133090|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.55|1.52|||Regression, Cox|||||1.52|0.55|
91620030|NCT00711269|183133097|SUPERIORITY|One-way Analysis of Variance (ANOVA)|LS Mean difference|-3.5||||0.149|TWO_SIDED|95.0|-8.4|1.3|||ANOVA||\[Not specified\]|||1.3|-8.4|0.149
91620031|NCT00711269|183133097|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.8||||0.462|TWO_SIDED|95.0|-6.6|3.0|||ANOVA|||||3.0|-6.6|0.462
91620032|NCT00711269|183133097|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-4.6||||0.122|TWO_SIDED|95.0|-10.5|1.2|||ANOVA|||||1.2|-10.5|0.122
91620033|NCT00711269|183133097|SUPERIORITY|Maximum Contrast Method||||||0.235||||||Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298|Maximum Contrast Method|Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145||||||0.235
91620034|NCT00711269|183133098|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.069|TWO_SIDED|95.0|-2.9|0.1|||ANOVA|||||0.1|-2.9|0.069
91620035|NCT00711269|183133098|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.8||||0.287|TWO_SIDED|95.0|-2.3|0.7|||ANOVA|||||0.7|-2.3|0.287
91620036|NCT00711269|183133098|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-2.3||||0.016|TWO_SIDED|95.0|-4.1|-0.4|||ANOVA|||||-0.4|-4.1|0.016
91620037|NCT00711269|183133099|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.289|TWO_SIDED|95.0|-2.0|0.6|||ANOVA|||||0.6|-2.0|0.289
91620038|NCT00711269|183133099|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.256|TWO_SIDED|95.0|-2.0|0.5|||ANOVA|||||0.5|-2.0|0.256
91620039|NCT00711269|183133099|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.352|TWO_SIDED|95.0|-2.3|0.8|||ANOVA|||||0.8|-2.3|0.352
91620040|NCT00711269|183133100|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.251|TWO_SIDED|95.0|-3.9|1.0|||ANOVA|||||1.0|-3.9|0.251
91620041|NCT00711269|183133100|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.2||||0.847|TWO_SIDED|95.0|-2.7|2.2|||ANOVA|||||2.2|-2.7|0.847
91620042|NCT00711269|183133100|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.6||||0.292|TWO_SIDED|95.0|-4.6|1.4|||ANOVA|||||1.4|-4.6|0.292
91791802|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.415||0.131|TWO_SIDED|95.0|-1.44|0.19|||ANCOVA|||Month 1||0.19|-1.44|0.131
91620043|NCT01628016|183133157|OTHER||Mean Difference (Final Values)|3.98||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
91620044|NCT03483506|183133159|OTHER||Geometric mean ratio|8.34|STANDARD_DEVIATION|50.5|||TWO_SIDED|90.0|5.88|11.82|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||11.82|5.88|
91620045|NCT03483506|183133161|OTHER||Geometric mean ratio|62.14|STANDARD_DEVIATION|24.4|||TWO_SIDED|90.0|52.08|74.14|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||74.14|52.08|
91620046|NCT00403559|183133181|NON_INFERIORITY|Non-inferiority determined as the F-IGA, IGA, erythema, scaling, and pruritis scores when compared between groups. The Wilcoxon rank sum test stratified baseline seborrheic dermatitis (SD) severity.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
91620047|NCT02768194|183133183|SUPERIORITY||Mean Difference (Net)|-0.11||||0.5512|TWO_SIDED|95.0|-0.46|0.25||From the MMRM model with change from pre-dose as response, participant as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.25|-0.46|0.5512
91620048|NCT02768194|183133183|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9671|TWO_SIDED|95.0|-0.36|0.35||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.35|-0.36|0.9671
91620049|NCT02768194|183133183|SUPERIORITY||Mean Difference (Net)|-0.1||||0.583|TWO_SIDED|95.0|-0.46|0.26||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.26|-0.46|0.5830
91791803|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.037|TWO_SIDED|95.0|-1.65|-0.05|||ANCOVA|||Month 1||-0.05|-1.65|0.037
91713299|NCT02326272|183317986|SUPERIORITY||Estimated difference in responder rate|71.0|||||TWO_SIDED|95.0|58.47|83.43|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||83.43|58.47|
91620050|NCT05291949|183133185|OTHER|Bland-Altman|Bias|0.3|||||TWO_SIDED||||||Bland-Altman||||Lower 95% Limit of agreement (LoA) value = -0.34 Upper 95% LoA = 0.94|||
91620051|NCT01029886|183133201|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was \<0.25%.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|0.08|0.33|||Mixed Models Analysis|||A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.33|0.08|0.002
91620052|NCT01029886|183133202|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.||||0.011
91620053|NCT01029886|183133203|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.15||0.021|TWO_SIDED|95.0|0.05|0.66|||Mixed Models Analysis|||MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.66|0.05|0.021
91620054|NCT01029886|183133204|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.39|1.4|||Mixed Models Analysis|||MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.40|0.39|<.001
91620055|NCT01029886|183133205|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.079|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.19|-0.01|0.079
91620056|NCT01029886|183133206|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.832|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.02|-0.02|0.832
91620057|NCT01029886|183133207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|1.04|1.15|||Mixed Models Analysis|||Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.15|1.04|<.001
91620058|NCT01029886|183133208|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.76||0.205|TWO_SIDED|95.0|-0.53|2.47|||Mixed Models Analysis|||MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||2.47|-0.53|0.205
91620059|NCT01029886|183133209|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.981|TWO_SIDED|95.0|-0.96|0.98|||Mixed Models Analysis|||MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.98|-0.96|0.981
91620060|NCT00242385|183133228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-35d divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.928|||||TWO_SIDED|90.0|0.858|1.002||||||||1.002|0.858|
91620061|NCT00242385|183133229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-infinity divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.934|||||TWO_SIDED|90.0|0.855|1.021||||||||1.021|0.855|
91620062|NCT02720016|183133239|SUPERIORITY||Slope|-3.216|STANDARD_ERROR_OF_MEAN|1.3||0.016|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.016
91620063|NCT02720016|183133239|SUPERIORITY||Slope|-4.11|STANDARD_ERROR_OF_MEAN|1.308||0.002|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.002
91620064|NCT02720016|183133239|SUPERIORITY||Slope|-0.894|STANDARD_ERROR_OF_MEAN|1.296||0.492|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.492
91713300|NCT02326272|183317987|SUPERIORITY||Odds Ratio (OR)|106.225|||<|0.0001|TWO_SIDED|97.5|9.572|1178.843||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1178.843|9.572|<0.0001
91620065|NCT02720016|183133244|SUPERIORITY||Slope|-0.352|STANDARD_ERROR_OF_MEAN|2.172||0.872|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.872
91713301|NCT02326272|183317987|SUPERIORITY||Estimated difference in responder rate|64.8|||||TWO_SIDED|95.0|52.16|77.46|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||77.46|52.16|
91524699|NCT02255032|182924756|SUPERIORITY||Mean Difference (Final Values)|-164.44|STANDARD_DEVIATION|173.148||0.0017|TWO_SIDED|95.0|-256.7|-72.2||The primary analysis of the primary efficacy endpoint was the comparison between the Baseline and Month 2 values for the 4 mg treatment group. No adjustments for multiplicity were necessary.|Paired t-test, two-sided|||"A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.~A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level."||-72.2|-256.7|0.0017
91620066|NCT02720016|183133244|SUPERIORITY||Slope|-0.931|STANDARD_ERROR_OF_MEAN|2.296||0.686|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.686
91620067|NCT02720016|183133244|SUPERIORITY||Slope|-0.579|STANDARD_ERROR_OF_MEAN|2.256||0.798|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.798
91620068|NCT02720016|183133249|SUPERIORITY||Slope|-1.213|STANDARD_ERROR_OF_MEAN|2.518||0.631|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.631
91620069|NCT02720016|183133249|SUPERIORITY||Slope|-1.461|STANDARD_ERROR_OF_MEAN|2.495||0.56|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.560
91620070|NCT02720016|183133249|SUPERIORITY||Slope|-0.248|STANDARD_ERROR_OF_MEAN|2.536||0.922|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.922
91620071|NCT04501679|183133275|SUPERIORITY||Strata-adjusted percentage difference|37.4|||<|0.0001|TWO_SIDED|95.0|26.3|48.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.5|26.3|<0.0001
91620072|NCT04501679|183133276|SUPERIORITY||Strata-adjusted percentage difference|28.5|||<|0.0001|TWO_SIDED|95.0|18.8|38.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.2|18.8|<0.0001
91620073|NCT04501679|183133277|SUPERIORITY||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.4||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||42.4|24.3|<0.0001
91620074|NCT04501679|183133278|SUPERIORITY||Strata-adjusted percentage difference|30.0|||<|0.0001|TWO_SIDED|95.0|21.3|38.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.6|21.3|<0.0001
91722429|NCT04390750|183337445|OTHER|The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 1 and Control at 6 months.|Interaction coefficient|-0.2||||0.014|TWO_SIDED|95.0|-0.36|-0.04|||Linear mixed effects model|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the secondary endpoint of 6 months.||-0.04|-0.36|0.014
91713302|NCT02326272|183317987|SUPERIORITY||Odds Ratio (OR)|133.163|||<|0.0001|TWO_SIDED|97.5|11.904|1489.578||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1489.578|11.904|<0.0001
91659414|NCT01819597|183213537|OTHER|This is a phase II study design to determine the non-futility of proceeding to a phase III pivotal evaluation. The study group was planned to be compared to a propensity score matching (PSM) cohort from to the patients in the medical arms of the SAMMPRIS trial and to patients in the medical arm of COSS that had demonstrated angiographic intracranial atherosclerosis and occlusion.|Hazard Ratio (HR)|0.38||||0.08|TWO_SIDED|90.0|0.14|0.94||Pre-established α ≤ 0.10 for phase IIa|Regression, Cox|Alpha set at ≤ 0.1. for phase II study|ERSIAS/ Controls.|We derived the sample size required to power the trial to test the difference between two binomial event rates using the method of Farrington and Manning as implemented in R package gsDesign (Anderson, 2011). An estimated sample size of 52 patients will be necessary to detect a ∆ of 0.05, with a one-sided alpha of 0.10 and a beta of 0.10 - acceptable parameters for a non-definitive, non-futility study (Palesch et al., 2005, Levin, 2005).||0.94|0.14|0.08
91659415|NCT02440711|183213573|SUPERIORITY|||||||0.18||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at slow walking speed||||.18
91659416|NCT02440711|183213573|SUPERIORITY|||||||0.21||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at comfortable walking speed||||.21
91659417|NCT02440711|183213573|SUPERIORITY|||||||0.16||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at fast walking speed||||.16
91659418|NCT02440711|183213575|SUPERIORITY|||||||0.29||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.29
91659419|NCT02440711|183213577|SUPERIORITY|||||||0.05||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.05
91659420|NCT02440711|183213579|SUPERIORITY|||||||0.25||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.25
91713303|NCT02326272|183317987|SUPERIORITY||Estimated difference in responder rate|69.6|||||TWO_SIDED|95.0|57.48|81.77|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||81.77|57.48|
91713304|NCT02326272|183317988|SUPERIORITY||Odds Ratio (OR)|24.283|||<|0.0001|TWO_SIDED|97.5|4.386|134.432||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||134.432|4.386|<0.0001
91659421|NCT02440711|183213581|SUPERIORITY|||||||0.86||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.86
91659422|NCT02440711|183213583|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step length results||||.14
91659423|NCT02440711|183213583|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step length results||||<0.001
91659424|NCT02440711|183213585|SUPERIORITY|||||||0.61||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step time results||||.61
91659425|NCT02440711|183213585|SUPERIORITY|||||||0.4||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step time results||||.40
91659426|NCT02440711|183213587|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.14
91659427|NCT02440711|183213589|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
91659428|NCT02440711|183213591|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
91659429|NCT02440711|183213593|SUPERIORITY|||||||0.005||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.005
91659430|NCT02440711|183213595|SUPERIORITY|||||||0.002||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AR results||||0.002
91713305|NCT02326272|183317988|SUPERIORITY||Estimated difference in responder rate|48.1|||||TWO_SIDED|95.0|35.04|61.26|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||61.26|35.04|
91713306|NCT02326272|183317988|SUPERIORITY||Odds Ratio (OR)|27.204|||<|0.0001|TWO_SIDED|97.5|4.895|151.198||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||151.198|4.895|<0.0001
91713307|NCT02326272|183317988|SUPERIORITY||Estimated difference in responder rate|51.0|||||TWO_SIDED|95.0|37.75|64.19|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.19|37.75|
91524700|NCT00125593|182924788|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.0021|TWO_SIDED|95.0|0.74|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.74|0.0021
91659431|NCT02440711|183213595|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-FUN results||||<0.001
91620075|NCT04501679|183133279|SUPERIORITY||Strata-adjusted percentage difference|31.9|||<|0.0001|TWO_SIDED|95.0|20.7|43.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||43.2|20.7|<0.0001
91620076|NCT04501679|183133280|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.|Strata-adjusted percentage difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.4|37.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|||37.5|18.4|<0.0001
91620077|NCT04501679|183133281|SUPERIORITY||Strata-adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|12.0|25.7||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.7|12.0|<0.0001
91620078|NCT02121756|183133290|OTHER|The sCD14 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD14||||||0.822|||||||Regression, Linear|||||||0.8220
91659432|NCT02440711|183213595|SUPERIORITY|||||||0.85||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AES results||||0.85
91659433|NCT00627016|183213616|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.|Wilcoxon (Mann-Whitney)|||||||<0.001
91713308|NCT02326272|183317991|SUPERIORITY||Adjusted Mean Treatment Differences|-6.62|||<|0.0001|TWO_SIDED|97.5|-8.88|-4.36||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.36|-8.88|<0.0001
91659434|NCT00627016|183213617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
91659435|NCT00627016|183213618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
91659436|NCT00234286|183213642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.009|TWO_SIDED|95.0|1.09|1.76|||Generalized Estimating Equation|||||1.76|1.09|.009
91659437|NCT00234286|183213643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
91659438|NCT00234286|183213644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.69|TWO_SIDED|95.0|0.59|1.42|||Generalized Estimating Equation|||||1.42|0.59|0.69
91524701|NCT00125593|182924789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.0012|TWO_SIDED|95.0|0.77|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.77|0.0012
91524702|NCT00125593|182924790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.001|TWO_SIDED|95.0|0.75|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.75|0.001
91659439|NCT00234286|183213645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.03|TWO_SIDED|95.0|0.53|0.96|||Generalized Estimating Equations|||||0.96|0.53|.03
91659440|NCT00234286|183213646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.15|TWO_SIDED|95.0|0.38|1.16|||Generalized Estimating Equation|||||1.16|0.38|0.15
91791804|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.423||0.008|TWO_SIDED|95.0|-1.96|-0.29|||ANCOVA|||Month 2||-0.29|-1.96|0.008
91791805|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.426|<|0.001|TWO_SIDED|95.0|-2.27|-0.6|||ANCOVA|||Month 2||-0.60|-2.27|< 0.001
91620079|NCT02121756|183133291|OTHER|The sCD163 is measured in ng/ml and the median change is shown in ng/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD163.||||||0.0869|||||||Regression, Linear|||||||0.0869
91620080|NCT02121756|183133292|OTHER|The IL-6 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma IL-6.||||||0.5027|||||||Regression, Linear|||||||0.5027
91620081|NCT02121756|183133293|OTHER|||||||0.4548|||||||Mixed Models Analysis|||||||0.4548
91620082|NCT02121756|183133295|OTHER|||||||0.7556|||||||Mixed Models Analysis|||||||0.7556
91620083|NCT02121756|183133296|OTHER|||||||0.2075|||||||Mixed Models Analysis|||||||0.2075
91620084|NCT02121756|183133297|OTHER|||||||0.0315|||||||Mixed Models Analysis|||||||0.0315
91620085|NCT02121756|183133298|OTHER|||||||0.7376|||||||Mixed Models Analysis|||||||0.7376
91620086|NCT02121756|183133299|OTHER|||||||0.2343|||||||Mixed Models Analysis|||||||0.2343
91620087|NCT02121756|183133300|OTHER|||||||0.7598|||||||Mixed Models Analysis|||||||0.7598
91620088|NCT02121756|183133301|OTHER|||||||0.983|||||||Mixed Models Analysis|||||||0.9830
91620089|NCT02121756|183133302|OTHER|||||||0.3317|||||||Mixed Models Analysis|||||||0.3317
91620090|NCT02121756|183133303|OTHER|||||||0.6121|||||||Mixed Models Analysis|||||||0.6121
91620091|NCT02121756|183133304|OTHER|||||||0.562|||||||Mixed Models Analysis|||||||0.5620
91620092|NCT00751114|183133318|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.77|-0.42||An analysis of covariance (ANCOVA) was performed, with the HbA1c change from baseline to last on-treatment measurement as dependent variable, treatment as fixed effect and the corresponding baseline HbA1c value as covariate|ANCOVA||Difference (Insulin glargine - Sitagliptin)|"H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~* Estimated standard deviation of the change in HbA1c of 1.3%~* Expected mean difference to be detected of 0.4%~* Alpha risk of 5% (two-sided)~* Power of 90%~* Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was required"||-0.42|-0.77|<0.0001
91620093|NCT03259490|183133328|OTHER||Adjusted gmean ratio T/R (%)|103.06|STANDARD_DEVIATION|5.8|||TWO_SIDED|95.0|100.36|105.83|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.83|100.36|
91620094|NCT03259490|183133329|OTHER||Adjusted gmean ratio T/R (%)|100.35|STANDARD_DEVIATION|9.5|||TWO_SIDED|95.0|96.11|104.77|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.77|96.11|
91620095|NCT03259490|183133330|OTHER||Adjusted gmean ratio T/R (%)|100.31|STANDARD_DEVIATION|8.2|||TWO_SIDED|95.0|96.65|104.1|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.10|96.65|
91620096|NCT03259490|183133331|OTHER||Adjusted gmean ratio T/R (%)|99.95|STANDARD_DEVIATION|12.4|||TWO_SIDED|95.0|94.52|105.7|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.70|94.52|
91620097|NCT03259490|183133332|OTHER||Adjusted gmean ratio T/R (%)|107.78|STANDARD_DEVIATION|11.0|||TWO_SIDED|95.0|102.52|113.31|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||113.31|102.52|
91659441|NCT00234286|183213647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.67|1.62|||Generalized Estimating Equation|||||1.62|0.67|0.86
91659442|NCT00234286|183213648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
91659443|NCT00234286|183213649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.01|TWO_SIDED|95.0|1.17|3.36|||Generalized Estimating Equation|||||3.36|1.17|0.01
91659444|NCT00234286|183213650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.36|TWO_SIDED|95.0|0.73|2.35|||Generalized Estimating Equation|||||2.35|0.73|0.36
91791806|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.434||0.036|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.036
91791807|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.431||0.035|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.035
91791808|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.453||0.452|TWO_SIDED|95.0|-1.23|0.55|||ANCOVA|||Month 4||0.55|-1.23|0.452
91713309|NCT02326272|183317991|SUPERIORITY||Adjusted Mean Treatment Differences|-6.19|||<|0.0001|TWO_SIDED|97.5|-8.46|-3.93||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.93|-8.46|<0.0001
91791809|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.432||0.002|TWO_SIDED|95.0|-2.18|-0.48|||ANCOVA|||Month 4||-0.48|-2.18|0.002
91620098|NCT03259490|183133333|OTHER||Adjusted gmean ratio T/R (%)|97.17|STANDARD_DEVIATION|10.6|||TWO_SIDED|95.0|92.63|101.93|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||101.93|92.63|
91620099|NCT03259490|183133334|OTHER||Adjusted gmean ratio T/R (%)|103.11|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|100.38|105.92|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.92|100.38|
91620100|NCT03259490|183133335|OTHER||Adjusted gmean ratio T/R (%)|100.17|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|95.68|104.86|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.86|95.68|
91620101|NCT03259490|183133336|OTHER||Adjusted gmean ratio T/R (%)|97.3|STANDARD_DEVIATION|13.2|||TWO_SIDED|95.0|91.65|103.29|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||103.29|91.65|
91620102|NCT03095521|183133337|NON_INFERIORITY|two-sided 95% CIs estimation used to confirm non-inferior efficacy in primary endpoint. A non-inferiority conclusion was made relating to the primary parameter only.||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||Arm Angal, Arm Antiangin||||0.028
91620103|NCT03095521|183133340|SUPERIORITY|||||||0.482|||||||Wilcoxon (Mann-Whitney)|||||||0.482
91620104|NCT03095521|183133342|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||change from baseline, 2 groups||||0.072
91620105|NCT05027516|183133343|SUPERIORITY||Ratio|1.05||||0.1026|TWO_SIDED|95.0|0.55|1.83|||Permutation testing|||||1.83|0.55|0.1026
91620106|NCT05027516|183133344|SUPERIORITY||Ratio|1.12||||1|TWO_SIDED|95.0|0.47|2.19|||Permutation testing|||For aminoglycosides||2.19|0.47|1
91659445|NCT00234286|183213651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.01|TWO_SIDED|95.0|1.08|1.77|||Generalized Estimating Equation|||||1.77|1.08|0.01
91620107|NCT05027516|183133344|SUPERIORITY||Ratio|1.01||||1|TWO_SIDED|95.0|0.69|1.44|||Permutation testing|||For betalactams||1.44|0.69|1
91620108|NCT05027516|183133344|SUPERIORITY||Ratio|3.79||||1|TWO_SIDED|95.0|0.05|20.15|||Permutation testing|||For bacitracin||20.15|0.05|1
91620109|NCT05027516|183133344|SUPERIORITY||Ratio|0.83||||1|TWO_SIDED|95.0|0.0|1.91|||Permutation testing|||For glycopeptides||1.91|0|1
91620110|NCT05027516|183133344|SUPERIORITY||Ratio|1.19||||1|TWO_SIDED|95.0|0.32|3.15|||Permutation testing|||For trimethoprim||3.15|0.32|1
91659446|NCT00234286|183213652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.76|TWO_SIDED|95.0|0.7|1.3|||Generalized Estimating Equation|||||1.30|0.70|0.76
91713310|NCT00583908|183317995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_DEVIATION|17.1|<|0.0001||95.0||||Paired t-test|t-test, 1 sided||mean difference was senofilcon A minus balafilcon A|Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation||||<0.0001
91791810|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.443||0.012|TWO_SIDED|95.0|-1.99|-0.25|||ANCOVA|||Month 5||-0.25|-1.99|0.012
91620111|NCT05027516|183133344|SUPERIORITY||Ratio|2.82||||1|TWO_SIDED|95.0|0.07|14.64|||Permutation testing|||For cationic antimicrobial peptides||14.64|0.07|1
91620112|NCT05027516|183133344|SUPERIORITY||Ratio|1.49||||1|TWO_SIDED|95.0|0.0|5.34|||Permutation testing|||For mupirocin||5.34|0|1
91620113|NCT05027516|183133344|SUPERIORITY||Ratio|1.2||||1|TWO_SIDED|95.0|0.0|3.22|||Permutation testing|||For metronidazole||3.22|0|1
91620114|NCT05027516|183133344|SUPERIORITY||Ratio|6.44||||1|TWO_SIDED|95.0|0.02|46.02|||Permutation testing|||For fluoroquinolones||46.02|0.02|1
91620115|NCT05027516|183133344|SUPERIORITY||Ratio|10.6||||1|TWO_SIDED|95.0|0.01|148.86|||Permutation testing|||For sulfonamides||148.86|0.01|1
91620116|NCT05027516|183133344|SUPERIORITY||Ratio|1.01||||0.5621|TWO_SIDED|95.0|0.79|1.27|||Permutation testing|||For tetracyclines||1.27|0.79|0.5621
91620117|NCT05027516|183133345|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.196
91620118|NCT05027516|183133345|SUPERIORITY|||||||0.568|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.568
91620119|NCT05027516|183133345|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.978
91659447|NCT00234286|183213653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.41|5.44|||Generalized Estimating Equation|||||5.44|1.41|.004
91659448|NCT00234286|183213654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.007|TWO_SIDED|95.0|1.51|11.28|||Generalized Estimating Equations|||||11.28|1.51|0.007
91659449|NCT00234286|183213655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.14|TWO_SIDED|95.0|0.84|3.2|||Generalized Estimating Equations|||||3.20|0.84|0.14
91620120|NCT05027516|183133345|SUPERIORITY|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.184
91620121|NCT00723073|183133346|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|STANDARD_DEVIATION|1.0||0.96|TWO_SIDED|95.0|0.89|1.1|||Fisher Exact|||||1.10|0.89|0.96
91620122|NCT00723073|183133347|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.38|2.7|||Fisher Exact|||||2.70|0.38|>0.99
91620123|NCT00723073|183133348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.44|1.97|||Fisher Exact|||||1.97|0.44|>0.99
91620124|NCT00723073|183133349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12|STANDARD_DEVIATION|1.0||0.48|TWO_SIDED|95.0|0.61|2.07|||Fisher Exact|||||2.07|0.61|0.48
91620125|NCT00723073|183133350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57|STANDARD_DEVIATION|1.0||0.57|TWO_SIDED|95.0|0.1|3.37|||Fisher Exact|||||3.37|0.10|0.57
91620126|NCT00723073|183133351|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
91620127|NCT00723073|183133354|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
91620128|NCT00723073|183133355|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
91620129|NCT01536119|183133356|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.27|TWO_SIDED|95.0|0.91|1.38|||Chi-squared|||"Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeks"||1.38|0.91|0.27
91620130|NCT01536119|183133357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.09||95.0|0.98|1.44|||Chi-squared|||||1.44|0.98|0.09
91620131|NCT01536119|183133358|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.06||95.0|1.0|1.13|||Fisher Exact|||||1.13|1.00|0.06
91620132|NCT01536119|183133359|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.02||95.0|1.01|1.19|||Chi-squared|||||1.19|1.01|0.02
91620133|NCT01536119|183133360|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||Brief scale used||||0.25
91620134|NCT01536119|183133361|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.29
91620135|NCT01536119|183133362|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
91620136|NCT01536119|183133363|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
91620137|NCT01536119|183133364|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
91620138|NCT01536119|183133365|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
91659450|NCT00234286|183213656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.003|TWO_SIDED|95.0|1.15|1.88|||Generalized Estimating Equation|||||1.88|1.15|.003
91659451|NCT00234286|183213657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.19|TWO_SIDED|95.0|0.62|9.7|||Generalized Estimation Equations|||||9.70|0.62|0.19
91659452|NCT00286754|183213677|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of SMI vs. UC|Wilcoxon (Mann-Whitney)|||The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.||||0.001
91659453|NCT00286754|183213677|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.108
91659454|NCT00286754|183213678|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for SMI vs UC|Wilcoxon (Mann-Whitney)|||The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.||||0.009
91659455|NCT00286754|183213678|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.047
91659456|NCT00286754|183213679|SUPERIORITY_OR_OTHER||||||<|3e-06|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||<0.000003
91659457|NCT00286754|183213679|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.012
91659458|NCT00286754|183213679|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.89
91659459|NCT00286754|183213680|SUPERIORITY_OR_OTHER||||||<|0.009|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||<0.009
91659460|NCT00286754|183213680|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.008
91659461|NCT00286754|183213680|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.9
91620139|NCT02365584|183133382|SUPERIORITY|"The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows:~* The equality of variances was to verified using the Levene's test. If it was significant AUC values were to be properly transformed.~* The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis.~* The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests."|Adjusted LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|17.7|=|0.5396|TWO_SIDED|95.0|-47.0|25.0|||ANCOVA|||Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.||25|-47|=0.5396
91620140|NCT00838916|183133400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.04|0.27|||ANCOVA|||||0.27|-0.04|
91791811|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.439|<|0.001|TWO_SIDED|95.0|-2.5|-0.78|||ANCOVA|||Month 5||-0.78|-2.5|< 0.001
91791812|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.478||0.13|TWO_SIDED|95.0|-1.67|0.21|||ANCOVA|||Month 6||0.21|-1.67|0.13
91620141|NCT00838916|183133400|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%||||||0.0086||||||p-value is for non-inferiority testing of albiglutide versus insulin glargine|t-test, 1 sided|||||||0.0086
91620142|NCT00838916|183133400|SUPERIORITY_OR_OTHER|||||||0.1463||||||p-value is for superiority testing of albiglutide versus insulin glargine|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - insulin glargine) is equal to zero.||||||0.1463
91620143|NCT01927419|183133411|SUPERIORITY||Mean Difference (Final Values)|49.5|||||TWO_SIDED|95.0|31.4|61.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|61.8|31.4|
91620144|NCT01927419|183133411|SUPERIORITY||Odds Ratio (OR)|12.52|||||TWO_SIDED|95.0|3.79|52.55|||Fisher Exact|||||52.55|3.79|
91620145|NCT01927419|183133412|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.21|0.59|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.59|0.21|
91620146|NCT01927419|183133413|SUPERIORITY||Mean Difference (Final Values)|44.5|||||TWO_SIDED|95.0|8.2|64.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|64.8|8.2|
91620147|NCT01927419|183133413|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|1.07|511.89|||Fisher Exact|||||511.89|1.07|
91620148|NCT01927419|183133414|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.14|0.97|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.97|0.14|
91620149|NCT03260205|183133475|SUPERIORITY||Difference in Least Square Mean|-5.9||||0.0242|TWO_SIDED|95.0|-11.01|-0.78|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.||-0.78|-11.01|0.0242
91659462|NCT00286754|183213681|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.880
91659463|NCT00286754|183213681|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.318
91791813|NCT01931670|183461154|SUPERIORITY||Difference in LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.454||0.001|TWO_SIDED|95.0|-2.34|-0.56|||ANCOVA|||Month 6||-0.56|-2.34|0.001
91791814|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-1.34|STANDARD_ERROR_OF_MEAN|1.01||0.186|TWO_SIDED|95.0|-3.32|0.65|||ANCOVA|||Month 1||0.65|-3.32|0.186
91659464|NCT00286754|183213682|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.306
91659465|NCT00286754|183213682|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.205
91620150|NCT03260205|183133476|SUPERIORITY||Difference in Least Mean Square|-0.6||||0.0074|TWO_SIDED|95.0|-1.03|-0.16|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.||-0.16|-1.03|0.0074
91620151|NCT01511107|183133496|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.172|STANDARD_DEVIATION|0.039|||TWO_SIDED|95.0|-0.253|-0.091||||||The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.||-.091|-.253|
91791815|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-3.09|STANDARD_ERROR_OF_MEAN|1.013||0.002|TWO_SIDED|95.0|-5.08|-1.1|||ANCOVA|||Month 1||-1.10|-5.08|0.002
91791816|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-1.31|STANDARD_ERROR_OF_MEAN|1.005||0.195|TWO_SIDED|95.0|-3.28|0.67|||ANCOVA|||Month 2||0.67|-3.28|0.195
91791817|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-3.65|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-5.63|-1.67|||ANCOVA|||Month 2||-1.67|-5.63|< 0.001
91791818|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|1.02||0.047|TWO_SIDED|95.0|-4.03|-0.02|||ANCOVA|||Month 3||-0.02|-4.03|0.047
91791819|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-3.2|STANDARD_ERROR_OF_MEAN|1.021||0.002|TWO_SIDED|95.0|-5.21|-1.19|||ANCOVA|||Month 3||-1.19|-5.21|0.002
91620152|NCT01511107|183133497|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.096|STANDARD_DEVIATION|0.053|||TWO_SIDED|95.0|-0.209|0.016||||||||.016|-.209|
91620153|NCT01511107|183133498|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.45
91620154|NCT01511107|183133499|SUPERIORITY_OR_OTHER|||||||0.95|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.95
91620155|NCT01511107|183133500|SUPERIORITY_OR_OTHER|||||||0.59|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.59
91620156|NCT01511107|183133501|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||>0.99
91620157|NCT01511107|183133502|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.47
91620158|NCT01511107|183133503|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.05
91620159|NCT01511107|183133504|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Logistic|The p-value is adjusted for the culture result at enrollment.||Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up||||0.58
91620160|NCT01511107|183133505|SUPERIORITY_OR_OTHER|||||||0.74|||||||Generalized estimating equations|||Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.||||0.74
91620161|NCT01511107|183133506|SUPERIORITY_OR_OTHER|||||||0.72|||||||Regression, Logistic|The p-value is adjusted for S pn susceptibility at the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.||||0.72
91620162|NCT01511107|183133507|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence.||||||0.05
91620163|NCT01511107|183133508|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|The p-value is adjusted for H flu susceptibility at onset of the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.||||0.47
91620164|NCT01511107|183133509|SUPERIORITY_OR_OTHER|||||||0.69|||||||Generalized estimating equations|The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence.||||||0.69
91620165|NCT01511107|183133510|SUPERIORITY_OR_OTHER|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.||||0.16
91620166|NCT01511107|183133511|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.||||0.32
91620167|NCT01511107|183133512|SUPERIORITY_OR_OTHER|||||||0.23|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.||||0.23
91620168|NCT01511107|183133513|SUPERIORITY_OR_OTHER|||||||0.22|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.||||0.22
91620169|NCT01511107|183133514|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|The p-value is adjusted for site \& the stratification variables and for length of follow-up.||Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.||||<.001
91620170|NCT01511107|183133515|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for site \& the stratification variables, episode, day of the diary and AOM-SOS score at the episode.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||0.07
91620171|NCT01511107|183133516|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.||||0.70
91620172|NCT01511107|183133517|SUPERIORITY_OR_OTHER|||||||0.86|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.||||0.86
91620173|NCT00975195|183133527|NON_INFERIORITY_OR_EQUIVALENCE|Upper limit of 95% confidence interval (CI) \<1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance|Hazard Ratio (HR)|1.058||||0.3497|TWO_SIDED|95.0|0.941|1.189||Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.|Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.189|0.941|0.3497
91620174|NCT00975195|183133528|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4441|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4441
91620175|NCT00975195|183133529|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED||||||Fisher Exact|||||||0.2269
91620176|NCT00975195|183133530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.0849|TWO_SIDED|95.0|0.975|1.481|||Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.481|0.975|0.0849
91620177|NCT00975195|183133531|SUPERIORITY_OR_OTHER||Rate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.13||0.2291|TWO_SIDED|95.0|0.92|1.45|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.45|0.92|0.2291
91620178|NCT00975195|183133532|SUPERIORITY_OR_OTHER|||||||0.2083|TWO_SIDED||||||Fisher Exact|||||||0.2083
91620179|NCT00975195|183133533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.5562|TWO_SIDED|95.0|0.923|1.16|||Chi-squared|||||1.160|0.923|0.5562
91620180|NCT00975195|183133534|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4342|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4342
91620181|NCT00975195|183133535|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||Fisher Exact|||||||0.3155
91620182|NCT00975195|183133537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.0134||0.0014|TWO_SIDED|95.0|-0.069|-0.017|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.017|-0.069|0.0014
91620183|NCT00975195|183133538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.064|STANDARD_ERROR_OF_MEAN|0.034||0.0632|TWO_SIDED|95.0|-0.004|0.131|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.131|-0.004|0.0632
91620184|NCT00975195|183133539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.055||0.8137|TWO_SIDED|95.0|-0.122|0.096|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.096|-0.122|0.8137
91620185|NCT00975195|183133540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.53|STANDARD_ERROR_OF_MEAN|3.17||0.2663|TWO_SIDED|95.0|-9.74|2.69|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.69|-9.74|0.2663
91620186|NCT00975195|183133541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06||0.0033|TWO_SIDED|95.0|0.05|0.27|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.27|0.05|0.0033
91659466|NCT00286754|183213683|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.011
91659467|NCT00286754|183213683|SUPERIORITY_OR_OTHER|||||||0.638|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.638
91659468|NCT00286754|183213684|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.012
91659469|NCT00286754|183213684|SUPERIORITY_OR_OTHER|||||||0.333|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.333
91620187|NCT00975195|183133542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.499||0.4914|TWO_SIDED|95.0|-3.98|1.91|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.91|-3.98|0.4914
91620188|NCT00975195|183133543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|1.669||0.349|TWO_SIDED|95.0|-4.84|1.71|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.71|-4.84|0.3490
91620189|NCT00975195|183133544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.48||0.9262|TWO_SIDED|95.0|-2.77|3.04|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||3.04|-2.77|0.9262
91620190|NCT00975195|183133545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.64|STANDARD_ERROR_OF_MEAN|1.716||0.1241|TWO_SIDED|95.0|-0.73|6.01|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||6.01|-0.73|0.1241
91620191|NCT00975195|183133546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.0123|<|0.0001|TWO_SIDED|95.0|-0.073|-0.024|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.024|-0.073|<0.0001
91620192|NCT00975195|183133547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0255||0.0855|TWO_SIDED|95.0|-0.094|0.006|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.006|-0.094|0.0855
91620193|NCT00975195|183133548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.161|STANDARD_ERROR_OF_MEAN|0.045||0.0004|TWO_SIDED|95.0|-0.249|-0.073|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.073|-0.249|0.0004
91620194|NCT00975195|183133549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.728||0.1838|TWO_SIDED|95.0|-0.46|2.4|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.40|-0.46|0.1838
91620195|NCT00975195|183133550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|0.702||0.0551|TWO_SIDED|95.0|-0.03|2.72|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.72|-0.03|0.0551
91620196|NCT00975195|183133551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.845||0.4804|TWO_SIDED|95.0|-1.06|2.25|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.25|-1.06|0.4804
91620197|NCT00975195|183133552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.614||0.0467|TWO_SIDED|95.0|0.02|2.43|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.43|0.02|0.0467
91620198|NCT00975195|183133553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0223|TWO_SIDED|95.0|-0.21|-0.02|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.02|-0.21|0.0223
91620199|NCT05195359|183133562|SUPERIORITY||||||<|0.0001|||||||ANOVA|Repeated measures ANOVA (Group × Time; app vs control; baseline vs week 12)||||||<0.0001
91791820|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.998||0.103|TWO_SIDED|95.0|-3.59|0.33|||ANCOVA|||Month 4||0.33|-3.59|0.103
91620200|NCT05195359|183133563|SUPERIORITY|||||||0.0003|||||||ANOVA|Repeated measures ANOVA (Group × Time; app vs control; baseline vs week 12)||||||0.0003
91620201|NCT05195359|183133564|SUPERIORITY|||||||0.0002|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app users vs control; baseline vs week 6)||||||0.0002
91620202|NCT05195359|183133565|SUPERIORITY|||||||0.0606|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app users vs control; baseline vs week 6)||||||0.0606
91713311|NCT00583908|183317995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|17.8||0.0002||95.0||||paired t-test|t-test, 1 sided||mean difference is senofilcon A minus lotrafilcon B|Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation||||0.0002
91791821|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-4.78|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-6.72|-2.83|||ANCOVA|||Month 4||-2.83|-6.72|< 0.001
91620203|NCT05195359|183133566|SUPERIORITY|||||||0.2056|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app users vs control; baseline vs week 6)||SF-12 Physical Wellbeing||||0.2056
91620204|NCT05195359|183133566|SUPERIORITY|||||||0.4186|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app users vs control; baseline vs week 6||SF-12 Mental Wellbeing||||0.4186
91620205|NCT05195359|183133567|SUPERIORITY|||||||0.0754|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app users vs control; baseline vs week 6)||||||0.0754
91620206|NCT05195359|183133568|SUPERIORITY|||||||0.0137|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app vs control; baseline vs week 12)||||||0.0137
91620207|NCT05195359|183133569|SUPERIORITY|||||||0.0152|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app vs control; baseline vs week 12)||||||0.0152
91620208|NCT05195359|183133570|SUPERIORITY|||||||0.8148|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app vs control; baseline vs week 12)||SF-12 Physical Wellbeing||||0.8148
91620209|NCT05195359|183133570|SUPERIORITY|||||||0.0523|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app vs control; baseline vs week 12)||SF-12 Mental Wellbeing||||0.0523
91620210|NCT05195359|183133571|SUPERIORITY|||||||0.0729|||||||ANOVA|Repeated measures ANOVA (Group × Time; frequent app vs control; baseline vs week 12)||||||0.0729
91620211|NCT01146951|183133572|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-26.65||||0.003|TWO_SIDED|90.0|-40.3|-11.8|||Wilcoxon (Mann-Whitney)|||||-11.80|-40.30|0.003
91620212|NCT01146951|183133573|SUPERIORITY_OR_OTHER|||||||0.074|||||||Fisher's exact test|||||||0.074
91620213|NCT01146951|183133574|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-33.3|||<|0.001|TWO_SIDED|90.0|-47.1|-17.0|||Wilcoxon (Mann-Whitney)|||||-17.00|-47.10|<0.001
91620214|NCT01146951|183133575|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-57.15||||0.025|TWO_SIDED|90.0|-104.5|-17.3|||Wilcoxon (Mann-Whitney)|||Analysis for Partial Seizure Frequency||-17.30|-104.50|0.025
91620215|NCT01146951|183133575|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-28.65||||0.128|TWO_SIDED|90.0|-72.0|0.9|||Wilcoxon (Mann-Whitney)|||Analysis of atypical absence seizure frequency||0.90|-72.00|0.128
91620216|NCT01146951|183133575|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-54.35||||0.021|TWO_SIDED|90.0|-126.6|-15.4|||Wilcoxon (Mann-Whitney)|||Analysis for myoclonic seizure frequency||-15.40|-126.60|0.021
91620217|NCT01146951|183133575|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-23.2||||0.031|TWO_SIDED|90.0|-40.7|-5.6|||Wilcoxon (Mann-Whitney)|||Analysis of tonic seizure frequency||-5.60|-40.70|0.031
91620218|NCT01146951|183133575|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-71.4||||0.107|TWO_SIDED|90.0|-464.7|30.5|||Wilcoxon (Mann-Whitney)|||Analysis for Tonic-clonic seizure frequency||30.50|-464.70|0.107
91620219|NCT01146951|183133575|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-52.1||||0.221|TWO_SIDED|90.0|-89.1|10.8|||Wilcoxon (Mann-Whitney)|||Analysis of Atonic seizure frequency||10.80|-89.10|0.221
91620220|NCT01146951|183133576|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Analysis of Week 12 of the Treatment Period||||0.041
91620221|NCT01146951|183133576|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Analysis of final assessment (LOCF)||||0.007
91620222|NCT01517412|183133584|NON_INFERIORITY_OR_EQUIVALENCE|A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.|Least square (LS) mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.067|0.242|||||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.||0.242|-0.067|
91620223|NCT01517412|183133584|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079||0.2664|TWO_SIDED|||||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.||||0.2664
91620224|NCT01253187|183133594|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.03||||||90.0|98.86|113.72||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.72|98.86|
91620225|NCT01253187|183133595|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|103.47||||||90.0|99.16|107.98||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.98|99.16|
91620226|NCT01253187|183133596|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|105.24||||||90.0|97.3|113.83||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.83|97.30|
91524703|NCT00125593|182924791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.37|TWO_SIDED|95.0|0.76|1.11|||Log Rank|||All analyses by intention to treat||1.11|0.76|0.37
91620227|NCT01253187|183133597|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.48||||||90.0|97.28|103.79||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.79|97.28|
91659470|NCT00286754|183213685|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.581
91659471|NCT00286754|183213685|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.502
91524704|NCT00125593|182924792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.6|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.60|0.01
91659472|NCT01054586|183213705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.1||||0.02||95.0|1.26|29.46||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for ART naïve. Not ART naïve is the reference group."|||29.46|1.26|0.02
91620228|NCT01253187|183133598|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|91.24|109.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||109.34|91.24|
91620229|NCT01253187|183133599|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.16||||||90.0|93.95|102.57||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.57|93.95|
91620230|NCT01253187|183133600|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.28||||||90.0|93.15|107.95||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.95|93.15|
91620231|NCT01253187|183133601|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|95.38|104.58||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.58|95.38|
91620232|NCT01253187|183133603|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.3||||||90.0|97.65|103.02||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|32 volunteers qualified for statistical analysis of BE whereas all 34 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.02|97.65|
91620233|NCT04124692|183133615|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91620234|NCT04124692|183133616|SUPERIORITY||||||=|0.0043|||||||Fisher Exact|||||||= 0.0043
91620235|NCT04124692|183133616|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91620236|NCT05136170|183133662|SUPERIORITY|The following null hypothesis was defined on this endpoint: the proportion of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) was lower or equal than control. The null hypothesis was rejected if the associated primary analysis p-value was lower than 0.025.|Odds Ratio (OR)|8.498||||0.002|TWO_SIDED|95.0|2.165|33.356||P-value of treatment variable from logistic regression model on proportion of patients reaching a value of Schirmer I test (without anesthesia) \>10mm/5min|Regression, Logistic|||Analysis was based on logistic regression model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \> 10 mm/5 min at Week 4 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||33.356|2.165|0.002
91620237|NCT05136170|183133663|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Adjusted means difference|0.59||||0.89|TWO_SIDED|95.0|-7.801|8.981||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with change from baseline in the global SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline global SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||8.981|-7.801|0.890
91791822|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|-4.2|-0.38|||ANCOVA|||Month 5||-0.38|-4.20|0.019
91791823|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-5.14|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|-7.06|-3.22|||ANCOVA|||Month 5||-3.22|-7.06|< 0.001
91791824|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|1.112||0.383|TWO_SIDED|95.0|-3.16|1.22|||ANCOVA|||Month 6||1.22|-3.16|0.383
91791825|NCT01931670|183461155|SUPERIORITY||Difference in LS Means|-3.02|STANDARD_ERROR_OF_MEAN|1.092||0.006|TWO_SIDED|95.0|-5.17|-0.87|||ANCOVA|||Month 6||-0.87|-5.17|0.006
91791826|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.422||0.975|TWO_SIDED|95.0|-0.81|0.84|||ANCOVA|||Month 1||0.84|-0.81|0.975
91524705|NCT00125593|182924793|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.0036|TWO_SIDED|95.0|0.68|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.68|0.0036
91524706|NCT00125593|182924794|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.41|TWO_SIDED|95.0|0.89|1.05|||Log Rank|||All analyses by intention to treat||1.05|0.89|0.41
91620238|NCT05136170|183133664|SUPERIORITY|Analysis was based on logistic regression model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \>10 mm/5 min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|6.648||||0.022|TWO_SIDED|95.0|1.307|33.808|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with proportion of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||33.808|1.307|0.022
91620239|NCT05136170|183133665|SUPERIORITY||Adjusted means difference|0.221||||0.962|TWO_SIDED|95.0|-8.934|9.377||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the severity SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline severity SANDE score as qualitative independent variables.Site was considered as random effects that vary randomly among patients.||9.377|-8.934|0.962
91620240|NCT05136170|183133666|SUPERIORITY||Adjusted means difference|0.164||||0.973|TWO_SIDED|95.0|-9.221|9.549||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the frequency SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline frequency SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||9.549|-9.221|0.973
91620241|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|2.378||||0.52|TWO_SIDED|95.0|-4.869|9.625||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 4||9.625|-4.869|0.52
91620242|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|7.11||||0.073|TWO_SIDED|95.0|-0.653|14.873||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 12||14.873|-0.653|0.073
91620243|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-4.166||||0.317|TWO_SIDED|95.0|-12.322|3.989||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 4.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 4||3.989|-12.322|0.317
91620244|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixedmodel for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall"|LS means difference|1.058||||0.792|TWO_SIDED|95.0|-6.786|8.901||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 12.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 12||8.901|-6.786|0.792
91620245|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|-3.907||||0.488|TWO_SIDED|95.0|-14.948|7.135||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 4.|Mixed Model for Repeated Measures|||QoL (Work) - Week 4||7.135|-14.948|0.488
91659473|NCT01054586|183213706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12||||0.05||95.0|1.03|16.5||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||16.50|1.03|0.05
91659474|NCT01054586|183213706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.68||95.0|0.16|16.27||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||16.27|0.16|0.68
91659475|NCT01054586|183213707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.83||||0.17||95.0|0.65|12.36||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||12.36|0.65|0.17
91791827|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.415||0.969|TWO_SIDED|95.0|-0.83|0.8|||ANCOVA|||Month 1||0.80|-0.83|0.969
91620246|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.284||||0.954|TWO_SIDED|95.0|-9.998|9.431||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 12.|Mixed Model for Repeated Measures|||QoL (Work) - Week 12||9.431|-9.998|0.954
91620247|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEl module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.049||||0.99|TWO_SIDED|95.0|-7.658|7.559||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 4||7.559|-7.658|0.99
91620248|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|1.976||||0.582|TWO_SIDED|95.0|-5.065|9.017||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 12||9.017|-5.065|0.582
91620249|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|5.232||||0.125|TWO_SIDED|95.0|-1.457|11.922||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 4.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 4||11.922|-1.457|0.125
91620250|NCT05136170|183133667|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.156||||0.964|TWO_SIDED|95.0|-6.912|6.6||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 12.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 12||6.6|-6.912|0.964
91620251|NCT05136170|183133668|SUPERIORITY||LS means difference|0.795||||0.102|TWO_SIDED|95.0|-0.157|1.748||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 4.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 4 was reported."||1.748|-0.157|0.102
91620252|NCT05136170|183133668|SUPERIORITY||LS means difference|-0.051||||0.923|TWO_SIDED|95.0|-1.094|0.991||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 8.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 8 was reported."||0.991|-1.094|0.923
91620253|NCT05136170|183133668|SUPERIORITY||LS means difference|0.136||||0.787|TWO_SIDED|95.0|-0.849|1.12||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 12|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 12 was reported."||1.12|-0.849|0.787
91620254|NCT05136170|183133669|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||<0.001
91620255|NCT05136170|183133669|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||<0.001
91620256|NCT05136170|183133669|SUPERIORITY|||||||0.014||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.014
91791828|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.22|STANDARD_ERROR_OF_MEAN|0.389||0.569|TWO_SIDED|95.0|-0.99|0.54|||ANCOVA|||Month 2||0.54|-0.99|0.569
91791829|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.393||0.311|TWO_SIDED|95.0|-1.17|0.37|||ANCOVA|||Month 2||0.37|-1.17|0.311
91791830|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|0.43|STANDARD_ERROR_OF_MEAN|0.505||0.398|TWO_SIDED|95.0|-0.56|1.42|||ANCOVA|||Month 3||1.42|-0.56|0.398
91524707|NCT04146896|182924795|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||0.704
91524708|NCT04146896|182924796|SUPERIORITY|||||||0.684|||||||t-test, 2 sided|||||||.684
91524709|NCT04146896|182924797|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
91620257|NCT05136170|183133669|SUPERIORITY|||||||0.095||||||Not statistically significant result. p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.095
91620258|NCT05136170|183133670|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.02
91620259|NCT05136170|183133670|SUPERIORITY|||||||0.328||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||0.328
91659476|NCT01054586|183213707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.85||95.0|0.12|13.33||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||13.33|0.12|0.85
91620260|NCT05136170|183133670|SUPERIORITY|||||||0.287||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.287
91620261|NCT05136170|183133670|SUPERIORITY|||||||0.777||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.777
91620262|NCT05136170|183133671|SUPERIORITY|||||||0.126||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.126
91713312|NCT00583908|183317995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.0|STANDARD_DEVIATION|12.4|<|0.0001||95.0||||paired t-test|t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation||||<0.0001
91620263|NCT05136170|183133671|SUPERIORITY|||||||0.968||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 8 (Visit 4) was reported.||||0.968
91620264|NCT05136170|183133671|SUPERIORITY|||||||0.613||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 12 (Visit 5) was reported.||||0.613
91791831|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.505||0.761|TWO_SIDED|95.0|-1.15|0.84|||ANCOVA|||Month 3||0.84|-1.15|0.761
91791832|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.491||0.874|TWO_SIDED|95.0|-0.89|1.04|||ANCOVA|||Month 4||1.04|-0.89|0.874
91791833|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.468||0.048|TWO_SIDED|95.0|-1.85|-0.01|||ANCOVA|||Month 4||-0.01|-1.85|0.048
91620265|NCT05136170|183133671|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 16 (Visit 6) was reported.||||0.805
91620266|NCT05136170|183133672|SUPERIORITY|||||||0.543||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 8 (Visit 4) was reported.||||0.543
91620267|NCT05136170|183133672|SUPERIORITY|||||||0.677||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 12 (Visit 5) was reported.||||0.677
91620268|NCT05136170|183133672|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global score - Week 16 (Visit 6) was reported.||||0.914
91620269|NCT05136170|183133672|SUPERIORITY|||||||0.874||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 8 (Visit 4) was reported.||||0.874
91620270|NCT05136170|183133672|SUPERIORITY|||||||0.945||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 12 (Visit 5) was reported.||||0.945
91620271|NCT05136170|183133672|SUPERIORITY|||||||0.727||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 16 (Visit 6) was reported.||||0.727
91620272|NCT05136170|183133672|SUPERIORITY|||||||0.342||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 8 (Visit 4) was reported.||||0.342
91791834|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.635||0.16|TWO_SIDED|95.0|-2.14|0.35|||ANCOVA|||Month 5||0.35|-2.14|0.16
91524710|NCT04146896|182924798|SUPERIORITY|||||||0.483|||||||t-test, 2 sided|||||||.483
91620273|NCT05136170|183133672|SUPERIORITY|||||||0.821||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 12 (Visit 5) was reported.||||0.821
91620274|NCT05136170|183133672|SUPERIORITY|||||||0.926||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 16 (Visit 6) was reported.||||0.926
91620275|NCT05136170|183133673|SUPERIORITY|||||||0.0344||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) - Week 4 (Visit 3) was reported.||||0.0344
91791835|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.63||0.152|TWO_SIDED|95.0|-2.14|0.33|||ANCOVA|||Month 5||0.33|-2.14|0.152
91791836|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.498||0.095|TWO_SIDED|95.0|-1.81|0.15|||ANCOVA|||Month 6||0.15|-1.81|0.095
91791837|NCT01931670|183461156|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.474||0.071|TWO_SIDED|95.0|-1.79|0.07|||ANCOVA|||Month 6||0.07|-1.79|0.071
91791838|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|1.106||0.098|TWO_SIDED|95.0|-4.01|0.34|||ANCOVA|||Month 1||0.34|-4.01|0.098
91791839|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-3.72|STANDARD_ERROR_OF_MEAN|1.113|<|0.001|TWO_SIDED|95.0|-5.91|-1.54|||ANCOVA|||Month 1||-1.54|-5.91|< 0.001
91620276|NCT05136170|183133673|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% - Week 4 (Visit 3) was reported.||||1
91620277|NCT05136170|183133673|SUPERIORITY|||||||0.0235||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 - Week 4 (Visit 3) was reported.||||0.0235
91620278|NCT05136170|183133674|SUPERIORITY|||||||0.888||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 4 (Visit 3) was reported.||||0.888
91620279|NCT05136170|183133674|SUPERIORITY|||||||0.651||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 8 (Visit 4) was reported.||||0.651
91620280|NCT05136170|183133674|SUPERIORITY|||||||0.267||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 12 (Visit 5) was reported.||||0.267
91620281|NCT05136170|183133674|SUPERIORITY|||||||0.459||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 16 (Visit 6) was reported.||||0.459
91620282|NCT05136170|183133674|SUPERIORITY|||||||0.192||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 4 was reported.||||0.192
91620283|NCT05136170|183133674|SUPERIORITY|||||||0.568||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 8 was reported.||||0.568
91620284|NCT05136170|183133674|SUPERIORITY|||||||0.871||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 12 was reported.||||0.871
91620285|NCT05136170|183133674|SUPERIORITY|||||||0.85||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 16 was reported.||||0.85
91620286|NCT05136170|183133674|SUPERIORITY|||||||0.364||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 4 was reported.||||0.364
91620287|NCT05136170|183133674|SUPERIORITY|||||||0.646||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 8 was reported.||||0.646
91620288|NCT05136170|183133674|SUPERIORITY|||||||0.739||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 12 was reported.||||0.739
91620289|NCT05136170|183133674|SUPERIORITY|||||||0.664||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 16 was reported.||||0.664
91620290|NCT05136170|183133674|SUPERIORITY|||||||0.846||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 4 was reported.||||0.846
91659477|NCT01054586|183213708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.2||||0.06||95.0|0.94|10.82||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||10.82|0.94|0.06
91659478|NCT01054586|183213708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.96||95.0|0.11|9.83||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||9.83|0.11|0.96
91713313|NCT00583908|183317996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.15||0.0083||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus balafilcon A|Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score||||0.0083
91620291|NCT05136170|183133674|SUPERIORITY|||||||0.248||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 8 was reported.||||0.248
91620292|NCT05136170|183133674|SUPERIORITY|||||||0.341||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 12 was reported.||||0.341
91620293|NCT05136170|183133674|SUPERIORITY|||||||0.413||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 16 was reported.||||0.413
91620294|NCT05136170|183133674|SUPERIORITY|||||||0.927||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 4 was reported.||||0.927
91620295|NCT05136170|183133674|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 8 was reported.||||0.914
91659479|NCT01054586|183213709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.57||95.0|0.52|3.31||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.31|0.52|0.57
91659480|NCT01054586|183213709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28||||0.22||95.0|0.04|2.14||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.14|0.04|0.22
91713314|NCT00583908|183317996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.09||0.052||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus lotrafilcon B|Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score||||0.052
91524711|NCT04146896|182924799|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||.199
91524712|NCT04146896|182924800|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||||||.273
91524713|NCT04146896|182924801|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||.668
91659481|NCT01054586|183213709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.47||95.0|0.35|9.91||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.91|0.35|0.47
91620296|NCT05136170|183133674|SUPERIORITY|||||||0.564||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 12 was reported.||||0.564
91620297|NCT05136170|183133674|SUPERIORITY|||||||0.489||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 16 was reported.||||0.489
91524714|NCT03107377|182924802|SUPERIORITY||Risk Difference (RD)|-4.81||||0.0256|TWO_SIDED|95.0|-9.02|-0.61|||Chi-squared|||||-0.61|-9.02|0.0256
91524715|NCT03107377|182924803|SUPERIORITY||Risk Difference (RD)|-2.53||||0.0316|TWO_SIDED|95.0|-4.84|-0.23|||Chi-squared|||||-0.23|-4.84|0.0316
91659482|NCT01054586|183213710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.48||95.0|0.55|3.55||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.55|0.55|0.48
91659483|NCT01054586|183213710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.23||95.0|0.03|2.18||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.18|0.03|0.23
91620298|NCT05136170|183133674|SUPERIORITY|||||||0.082||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 4||||0.082
91620299|NCT05136170|183133674|SUPERIORITY|||||||0.848||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 8 was reported.||||0.848
91659484|NCT01054586|183213710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.56||95.0|0.29|9.47||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.47|0.29|0.56
91659485|NCT01054586|183213712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.72||95.0|0.51|2.66||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||2.66|0.51|0.72
91713315|NCT00583908|183317996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.14||0.015||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score||||0.015
91713316|NCT00583908|183317997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_DEVIATION|6.5||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.16
91713317|NCT00583908|183317997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|3.5||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.73
91620300|NCT05136170|183133674|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 12 was reported.||||0.805
91659486|NCT01054586|183213712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||0.21||95.0|0.03|2.08||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.08|0.03|0.21
91659487|NCT01054586|183213712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26||||0.15||95.0|0.74|6.97|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.||6.97|0.74|0.15
91659488|NCT01054586|183213718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.77||||0.1||95.0|0.79|18.05|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||18.05|0.79|0.10
91524716|NCT03107377|182924807|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
91620301|NCT05136170|183133674|SUPERIORITY|||||||0.833||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Symptom-Bother - Week 16 was reported.||||0.833
91620302|NCT05136170|183133677|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||<0.001
91620303|NCT05136170|183133678|SUPERIORITY|||||||0.046||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.046
91620304|NCT05136170|183133679|SUPERIORITY|||||||0.34||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.34
91620305|NCT05136170|183133680|SUPERIORITY|||||||0.017||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 2 was reported||||0.017
91620306|NCT05136170|183133680|SUPERIORITY|||||||0.339||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 4 was reported||||0.339
91620307|NCT05136170|183133680|SUPERIORITY|||||||0.004||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 2 was reported.||||0.004
91620308|NCT05136170|183133680|SUPERIORITY|||||||0.292||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 4 was reported.||||0.292
91620309|NCT05136170|183133680|SUPERIORITY|||||||0.09||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 2 was reported.||||0.09
91620310|NCT05136170|183133680|SUPERIORITY|||||||0.54||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 4 was reported.||||0.54
91620311|NCT05136170|183133681|SUPERIORITY|||||||0.0064||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) was reported.||||0.0064
91659489|NCT01054586|183213719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.53||||0.02||95.0|1.16|5.54||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.54|1.16|0.02
91713318|NCT00583908|183317997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|4.4||0.044||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|||||0.044
91524717|NCT03107377|182924807|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||1.0000
91524718|NCT03107377|182924807|SUPERIORITY|||||||0.6278|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||.6278
91620312|NCT05136170|183133681|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% was reported.||||1
91620313|NCT05136170|183133681|SUPERIORITY|||||||0.0034||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 was reported.||||0.0034
91620314|NCT05136170|183133682|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||||||<0.001
91620315|NCT05168813|183133695|OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.77|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||0.77|0.44|< .001
91620316|NCT05168813|183133696|OTHER||Hazard Ratio (HR)|0.48||||0.003|TWO_SIDED|95.0|0.29|0.78|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||0.78|0.29|0.003
91620317|NCT05168813|183133697|OTHER||Hazard Ratio (HR)|0.27||||0.056|TWO_SIDED|95.0|0.07|1.04|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||1.04|0.07|0.056
91620318|NCT05168813|183133698|OTHER||Hazard Ratio (HR)|0.92||||0.449|TWO_SIDED|95.0|0.73|1.15|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||1.15|0.73|0.449
91659490|NCT01054586|183213719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.17||||0.05||95.0|1.54|11.27||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||11.27|1.54|0.05
91659491|NCT01054586|183213719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.67||||0.06||95.0|0.97|13.9||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||13.90|0.97|0.06
91659492|NCT01054586|183213720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.68||||0.01||95.0|1.21|5.9||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.9|1.21|0.01
91659493|NCT01054586|183213720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.42||||0.0004||95.0|1.61|12.08||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||12.08|1.61|0.0004
91713319|NCT00583908|183317998|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.1|STANDARD_DEVIATION|5.0||0.044||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.044
91713320|NCT00583908|183317998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|4.7||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
91524719|NCT03107377|182924807|SUPERIORITY|||||||0.6404|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=40% adherence||||.6404
91659494|NCT01054586|183213720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.07||||0.11||95.0|0.78|12.03||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||12.03|0.78|0.11
91659495|NCT01054586|183213721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.03||95.0|1.06|4.15||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||4.15|1.06|0.03
91659496|NCT01054586|183213721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.61||||0.05||95.0|1.48|8.81||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||8.81|1.48|0.05
91659497|NCT01054586|183213721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.31||||0.1||95.0|0.85|6.32||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||6.32|0.85|0.10
91713321|NCT00583908|183317998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|5.9||0.44||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.44
91713322|NCT00583908|183317999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|6.5||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.78
91713323|NCT00583908|183317999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|6.3||0.68||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.68
91524720|NCT03107377|182924807|SUPERIORITY|||||||0.5008|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||.5008
91659498|NCT01054586|183213722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.12||||0.03||95.0|1.19|22.02|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||22.02|1.19|0.03
91659499|NCT02726581|183213730|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||||1.30|0.62|
91659500|NCT02726581|183213731|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.19||||||||1.19|0.53|
91713324|NCT00583908|183317999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|7.6||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.78
91713325|NCT00583908|183318000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|6.5||0.11||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.11
91713326|NCT00583908|183318000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|4.3||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
91524721|NCT03107377|182924807|SUPERIORITY|||||||0.1818|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||.1818
91659501|NCT02726581|183213732|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.46||||||||1.46|0.39|
91659502|NCT02255097|183213782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
91713327|NCT00583908|183318000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0|STANDARD_DEVIATION|6.3||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.16
91713328|NCT00583908|183318001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_DEVIATION|6.8||0.061||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.061
91713329|NCT00583908|183318001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.9||0.47||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.47
91713330|NCT00583908|183318001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|3.6||0.38||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.38
91620319|NCT05168813|183133699|OTHER||Hazard Ratio (HR)|2.29||||0.23|TWO_SIDED|95.0|0.59|8.87|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||8.87|0.59|0.23
91620320|NCT05168813|183133709|OTHER||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.43|0.73|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||0.73|0.43|< .001
91620321|NCT05168813|183133710|OTHER||Hazard Ratio (HR)|0.43|||<|0.001|TWO_SIDED|95.0|0.27|0.68|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||0.68|0.27|< .001
91620322|NCT05168813|183133711|OTHER||Hazard Ratio (HR)|0.27||||0.02|TWO_SIDED|95.0|0.09|0.82|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||0.82|0.09|0.02
91620323|NCT05168813|183133712|OTHER||Hazard Ratio (HR)|0.86||||0.218|TWO_SIDED|95.0|0.67|1.09|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||1.09|0.67|0.218
91620324|NCT05168813|183133713|OTHER||Hazard Ratio (HR)|1.78||||0.135|TWO_SIDED|95.0|0.84|3.77|||Regression, Cox|Adjusted for variables expected to affect risk of future COVID-19 and evidence of prior SARS-CoV-2 exposure.||||3.77|0.84|0.135
91620325|NCT01089582|183133724|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.||||0.0023
91713331|NCT00583908|183318002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|3.5||0.17||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.17
91524722|NCT03107377|182924807|SUPERIORITY|||||||0.0012|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||0.0012
91620326|NCT01089582|183133725|SUPERIORITY_OR_OTHER|||||||0.0382|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.||||0.0382
91713332|NCT00583908|183318002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|5.0||0.89||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.89
91713333|NCT00583908|183318002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|5.8||0.56||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.56
91713334|NCT00583908|183318003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|6.8||0.008||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.0080
91713335|NCT00583908|183318003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|3.1||0.0049||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.0049
91713336|NCT00583908|183318003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|5.6||0.0058||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.0058
91713337|NCT00583908|183318004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|3.7||0.27||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.27
91713338|NCT00583908|183318004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|6.0||0.85||95.0|||||t-test, 1 sided||Mean difference is senofilocon A minus lotrafilcon B|||||0.85
91713339|NCT00583908|183318004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|2.6||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omifilcon A|||||0.73
91713340|NCT04033146|183318011|OTHER||||||<|0.001||||||Threshold was 0.05|ANOVA|||"H1. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for young adults.~H2. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for older adults."||||<0.001
91713341|NCT00928434|183318030|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.|Percentage difference|1.57|||||TWO_SIDED|95.0|-0.19|3.33||||||||3.33|-0.19|
91791840|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|1.091||0.065|TWO_SIDED|95.0|-4.16|0.13|||ANCOVA|||Month 2||0.13|-4.16|0.065
91524723|NCT03107377|182924808|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
91620327|NCT01089582|183133726|SUPERIORITY_OR_OTHER|||||||0.1805|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.1805
91620328|NCT01089582|183133726|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.||||<0.0001
91620329|NCT01089582|183133726|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
91620330|NCT01089582|183133727|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.0137
91620331|NCT01089582|183133727|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.||||<0.0001
91620332|NCT01089582|183133727|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
91620333|NCT04069156|183133731|NON_INFERIORITY|The primary end point assessing non-inferiority of placebo was considered met if the lower boundary of the one-sided 97.5% confidence limit of the difference in the composite success rate between treatment arms (placebo minus aspirin) was greater than the non-inferiority margin (-10%) by the Farrington-Manning test at 12-months in the principal analysis population.|Risk Difference (RD)|6.0|||<|0.0001|ONE_SIDED|97.5|-1.6||||Farrington-Manning risk difference||||||-1.6|<0.0001
91620334|NCT05822830|183133762|SUPERIORITY||LS Mean Difference|-6.5|||||TWO_SIDED|95.0|-8.1|-4.9||||||||-4.9|-8.1|
91524724|NCT03107377|182924808|SUPERIORITY|||||||0.4375|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||0.4375
91620335|NCT05822830|183133767|SUPERIORITY||LS Mean Difference|-5.4|||||TWO_SIDED|95.0|-7.1|-3.6||||||||-3.6|-7.1|
91620336|NCT05822830|183133769|SUPERIORITY||LS Mean Difference|-2.6|||||TWO_SIDED|95.0|-3.2|-1.9||||||||-1.9|-3.2|
91620337|NCT05822830|183133770|SUPERIORITY||LS Mean Difference|-6.4|||||TWO_SIDED|95.0|-8.0|-4.7||||||||-4.7|-8.0|
91620338|NCT05441592|183133788|SUPERIORITY|||||||0.486|||||||Fisher Exact|||||||0.486
91620339|NCT05441592|183133790|SUPERIORITY|||||||0.234|||||||Fisher Exact|||||||0.234
91620340|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.3|<0.001
91659503|NCT02255097|183213783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
91659504|NCT02255097|183213786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
91620341|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|6.8|13.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.1|6.8|<0.001
91659505|NCT02255097|183213787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||0.0027
91620342|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|10.7|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|7.7|13.8|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.8|7.7|<0.001
91791841|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-5.1|STANDARD_ERROR_OF_MEAN|1.089|<|0.001|TWO_SIDED|95.0|-7.24|-2.96|||ANCOVA|||Month 2||-2.96|-7.24|< 0.001
91620343|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|13.4|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|10.3|16.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||16.5|10.3|<0.001
91659506|NCT02255097|183213788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
91791842|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|1.14||0.02|TWO_SIDED|95.0|-4.89|-0.41|||ANCOVA|||Month 3||-0.41|-4.89|0.02
91791843|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-4.64|STANDARD_ERROR_OF_MEAN|1.135|<|0.001|TWO_SIDED|95.0|-6.87|-2.41|||ANCOVA|||Month 3||-2.41|-6.87|< 0.001
91791844|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-2.72|STANDARD_ERROR_OF_MEAN|1.138||0.017|TWO_SIDED|95.0|-4.95|-0.48|||ANCOVA|||Month 4||-0.48|-4.95|0.017
91791845|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-6.27|STANDARD_ERROR_OF_MEAN|1.124|<|0.001|TWO_SIDED|95.0|-8.48|-4.06|||ANCOVA|||Month 4||-4.06|-8.48|< 0.001
91791846|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|1.095||0.023|TWO_SIDED|95.0|-4.64|-0.34|||ANCOVA|||Month 5||-0.34|-4.64|0.023
91791847|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-5.83|STANDARD_ERROR_OF_MEAN|1.095|<|0.001|TWO_SIDED|95.0|-7.98|-3.68|||ANCOVA|||Month 5||-3.68|-7.98|< 0.001
91791848|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|1.264||0.311|TWO_SIDED|95.0|-3.77|1.2|||ANCOVA|||Month 6||1.20|-3.77|0.311
91791849|NCT01931670|183461157|SUPERIORITY||Difference in LS Means|-3.97|STANDARD_ERROR_OF_MEAN|1.241||0.001|TWO_SIDED|95.0|-6.42|-1.53|||ANCOVA|||Month 6||-1.53|-6.42|0.001
91791850|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.81|0.62|||ANCOVA|||Month 1||0.62|-1.81|0.335
91791851|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.611||0.242|TWO_SIDED|95.0|-1.91|0.48|||ANCOVA|||Month 1||0.48|-1.91|0.242
91791852|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.652||0.042|TWO_SIDED|95.0|-2.61|-0.05|||ANCOVA|||Month 2||-0.05|-2.61|0.042
91659507|NCT02255097|183213789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
91791853|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-1.77|STANDARD_ERROR_OF_MEAN|0.656||0.007|TWO_SIDED|95.0|-3.06|-0.48|||ANCOVA|||Month 2||-0.48|-3.06|0.007
91791854|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.71||0.503|TWO_SIDED|95.0|-1.87|0.92|||ANCOVA|||Month 3||0.92|-1.87|0.503
91791855|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.707||0.169|TWO_SIDED|95.0|-2.36|0.41|||ANCOVA|||Month 3||0.41|-2.36|0.169
91791856|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.737||0.675|TWO_SIDED|95.0|-1.76|1.14|||ANCOVA|||Month 4||1.14|-1.76|0.675
91524725|NCT03107377|182924808|SUPERIORITY|||||||0.4444|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||0.4444
91524726|NCT03107377|182924808|SUPERIORITY|||||||0.1836|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||0.1836
91620344|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|STANDARD_ERROR_OF_MEAN|1.42||0.001|TWO_SIDED|95.0|1.8|7.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||7.4|1.8|0.001
91620345|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|4.1|STANDARD_ERROR_OF_MEAN|1.42||0.004|TWO_SIDED|95.0|1.3|6.9|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||6.9|1.3|0.004
91620346|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|9.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|6.9|12.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||12.5|6.9|<0.001
91620347|NCT01021852|183133791|SUPERIORITY_OR_OTHER||Difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|5.9|11.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.9|<0.001
91659508|NCT02255097|183213790|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
91659509|NCT03956862|183213800|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9499|TWO_SIDED|95.0|-7.6|7.1|||Mixed Models Analysis||GB001 vs. Placebo|||7.1|-7.6|0.9499
91659510|NCT03956862|183213801|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6778|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA||GB001 vs. Placebo|||1.2|-1.8|0.6778
91659511|NCT03956862|183213802|SUPERIORITY||Mean Difference (Net)|0.1||||0.7914|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis||GB001 vs. Placebo|||0.9|-0.7|0.7914
91524727|NCT03107377|182924808|SUPERIORITY|||||||0.5006|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||0.5006
91791857|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.703||0.002|TWO_SIDED|95.0|-3.55|-0.79|||ANCOVA|||Month 4||-0.79|-3.55|0.002
91791858|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-2.04|STANDARD_ERROR_OF_MEAN|0.856||0.017|TWO_SIDED|95.0|-3.72|-0.36|||ANCOVA|||Month 5||-0.36|-3.72|0.017
91791859|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-2.54|STANDARD_ERROR_OF_MEAN|0.848||0.003|TWO_SIDED|95.0|-4.21|-0.87|||ANCOVA|||Month 5||-0.87|-4.21|0.003
91791860|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|0.778||0.042|TWO_SIDED|95.0|-3.12|-0.06|||ANCOVA|||Month 6||-0.06|-3.12|0.042
91659512|NCT03956862|183213803|SUPERIORITY||Hazard Ratio (HR)|0.944||||0.8916|TWO_SIDED|95.0|0.41|2.173|||Regression, Cox||GB001 vs Placebo|||2.173|0.410|0.8916
91659513|NCT03956862|183213804|SUPERIORITY||Mean Difference (Net)|0.191||||0.1635|TWO_SIDED|95.0|-0.077|0.459|||Mixed Models Analysis||GB001 vs. Placebo|||0.459|-0.077|0.1635
91659514|NCT03956862|183213805|SUPERIORITY||Mean Difference (Net)|0.632||||0.1742|TWO_SIDED|95.0|-0.28|1.544|||Mixed Models Analysis||GB001 vs. Placebo|||1.544|-0.280|0.1742
91659515|NCT03956862|183213806|SUPERIORITY||Mean Difference (Net)|0.9||||0.4851|TWO_SIDED|95.0|-1.6|3.4|||ANCOVA||GB001 vs. Placebo|||3.4|-1.6|0.4851
91713342|NCT00447772|183318058|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.322|||=|0.2552|TWO_SIDED|95.0|-0.877|0.233|||ANCOVA||The comparative analysis is based on adjusted means data.|An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).||0.233|-0.877|=0.2552
91524728|NCT03107377|182924808|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||1.000
91659516|NCT03956862|183213807|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.3898|TWO_SIDED|95.0|0.136|2.178|||Regression, Cox||GB001 vs Placebo|||2.178|0.136|0.3898
91659517|NCT03965091|183213817|OTHER||Least square (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7963|TWO_SIDED|95.0|-0.46|0.6|||Mixed Models Analysis|||Analysis was performed using a Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.60|-0.46|0.7963
91659518|NCT03965091|183213817|OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.8629|TWO_SIDED|95.0|-0.48|0.58|||Mixed Models Analysis|||Analysis was performed using an MMRM model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.58|-0.48|0.8629
91524729|NCT01597505|182924811|NON_INFERIORITY|Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.|Difference in percentage of participants|-4.6|||||TWO_SIDED|95.0|-11.0|1.9|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in percentage of participants||1.9|-11.0|
91659519|NCT00565448|183213837|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||The Fisher's exact test was used to compare the CR proportions.|Fisher Exact|||There was no formal power calculation. A selection design was used to determine how many participants would be accrued to correctly select the treatment group with the best CR rate with 80% probability.||||1.0000
91659520|NCT00302952|183213843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||||||Adjustments were made for baseline ln(CRP), baseline DAS28-CRP score, race, methotrexate use, anti-TNF use, and disease duration.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group. Log transformed CRP was analyzed to meet the heterogeneity assumption for ANCOVA models.||||0.79
91659521|NCT00302952|183213845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||Adjustments were made for baseline DAS28-CRP score.|ANCOVA|ANOVA was performed on participants with a DAS28-CRP score at Day 84.||The p-value compares Lovastatin with the Placebo treatment group.||||0.91
91659522|NCT00302952|183213846|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-11.0||||0.39|TWO_SIDED|95.0|-35.9|14.0|||Chi-squared||The difference in percentages is calculated as Lovastatin - Placebo.|The p-value compares Lovastatin with the Placebo treatment group.||14.0|-35.9|0.39
91722430|NCT04390750|183337445|OTHER|The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 2 and Control at 6 months.|Interaction coefficient|-0.23||||0.005|TWO_SIDED|95.0|-0.39|-0.07|||Linear mixed effects model.|Linear mixed effects model with arm-by-time interaction.||A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the secondary endpoint of 6 months.||-0.07|-0.39|0.005
91659523|NCT00302952|183213847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Adjustments were made for baseline serum IgM RF by ELISA test result. In the ANCOVA model, baseline value was a covariate; therefore, an adjustment was performed.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.19
91659524|NCT00302952|183213848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Adjustments were made for baseline serum anti-CCP by ELISA|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.35
91659525|NCT02979353|183213858|SUPERIORITY||Risk Ratio (RR)|0.96||||0.017|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)||||0.017
91659526|NCT02979353|183213858|SUPERIORITY||Risk Ratio (RR)|0.86|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)||||<0.0001
91659527|NCT02979353|183213858|SUPERIORITY||Risk Ratio (RR)|0.85|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)||||<0.0001
91659528|NCT02979353|183213859|SUPERIORITY||Mean Difference (Net)|-0.28||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)||||0.02
91659529|NCT02979353|183213859|SUPERIORITY||Mean Difference (Net)|-0.59|||<|1e-05|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).||||<0.00001
91659530|NCT02979353|183213859|SUPERIORITY||Mean Difference (Net)|-0.35||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).||||0.01
91659531|NCT04185909|183213869|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
91713343|NCT02427841|183318067|SUPERIORITY|Tested against the standard R0 rate of 37%. Given all evaluable patients are included in the denominator, R0 of 56% was not achieved. Specifically, of the 19 evaluable patients, 11 proceeded to surgery. Of the 11 who underwent surgery, 8 \[42% of those enrolled, but 72.7% of those resected\] achieved R0 resection.|binomial|42.0||||0.404|TWO_SIDED|95.0|20.0|67.0||Study was underpowered.|2-sided exact binomial||Test for superiority over standard R0 resection rate of 37%. Study was closed due to slow enrollment, meaning the primary endpoint was underpowered with only 19 of an expected 44 patients enrolled.|Study closed early due to lack of enrollment. Study expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%||67|20|.404
91659532|NCT03435081|183213895|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|2.31|9.15|||Regression, Logistic|||||9.15|2.31|<0.001
91659533|NCT03435081|183213896|SUPERIORITY||Odds Ratio (OR)|2.51||||0.033|TWO_SIDED|95.0|1.08|5.83|||Regression, Logistic|||||5.83|1.08|0.033
91659534|NCT03435081|183213896|SUPERIORITY||Odds Ratio (OR)|5.29|||<|0.001|TWO_SIDED|95.0|2.4|11.68|||Regression, Logistic|||||11.68|2.40|<0.001
91524730|NCT01597505|182924812|SUPERIORITY|||||||0.832||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified log-rank test p-value||||0.832
91524731|NCT01597505|182924813|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-0.8|||||TWO_SIDED|95.0|-8.8|7.1|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||7.1|-8.8|
91659535|NCT03435081|183213897|SUPERIORITY||Odds Ratio (OR)|1.71||||0.167|TWO_SIDED|95.0|0.8|3.63|||Regression, Logistic|||||3.63|0.80|0.167
91659536|NCT03435081|183213898|SUPERIORITY||Odds Ratio (OR)|2.23||||0.131|TWO_SIDED|95.0|0.79|6.31|||Regression, Logistic|||||6.31|0.79|0.131
91659537|NCT03435081|183213898|SUPERIORITY||Odds Ratio (OR)|6.73|||<|0.001|TWO_SIDED|95.0|2.63|17.19|||Regression, Logistic|||||17.19|2.63|<0.001
91659538|NCT03435081|183213899|SUPERIORITY||Mean Difference (Final Values)|-12.59|STANDARD_ERROR_OF_MEAN|7.079||0.077|TWO_SIDED|95.0|-26.54|1.36|||Mixed Models Analysis|||||1.36|-26.54|0.077
91713344|NCT01305811|183318087|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||general estimating equations|||||||0.03
91659539|NCT03435081|183213899|SUPERIORITY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|6.875||0.004|TWO_SIDED|95.0|-33.85|-6.75|||Mixed Models Analysis|||||-6.75|-33.85|0.004
91659540|NCT03435081|183213900|SUPERIORITY||Odds Ratio (OR)|1.24||||0.733|TWO_SIDED|95.0|0.36|4.36|||Regression, Logistic|||||4.36|0.36|0.733
91659541|NCT03435081|183213900|SUPERIORITY||Odds Ratio (OR)|5.42||||0.002|TWO_SIDED|95.0|1.93|15.22|||Regression, Logistic|||||15.22|1.93|0.002
91659542|NCT03435081|183213901|SUPERIORITY||Odds Ratio (OR)|3.08||||0.012|TWO_SIDED|95.0|1.29|7.36|||Regression, Logistic|||||7.36|1.29|0.012
91659543|NCT03435081|183213901|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.001|TWO_SIDED|95.0|2.31|12.28|||Regression, Logistic|||||12.28|2.31|<0.001
91659544|NCT03435081|183213902|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.273||0.433|TWO_SIDED|95.0|-0.75|0.32|||Mixed Models Analysis|||||0.32|-0.75|0.433
91659545|NCT03435081|183213902|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.269||0.029|TWO_SIDED|95.0|-1.12|-0.06|||Mixed Models Analysis|||||-0.06|-1.12|0.029
91659546|NCT03435081|183213903|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.441||0.012|TWO_SIDED|95.0|-1.99|-0.25|||Mixed Models Analysis|||||-0.25|-1.99|0.012
91659547|NCT03435081|183213903|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.433||0.002|TWO_SIDED|95.0|-2.22|-0.51|||Mixed Models Analysis|||||-0.51|-2.22|0.002
91659548|NCT03435081|183213904|SUPERIORITY||Odds Ratio (OR)|1.69||||0.105|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|||||3.20|0.90|0.105
91659549|NCT03435081|183213904|SUPERIORITY||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|2.02|6.68|||Regression, Logistic|||||6.68|2.02|<0.001
91659550|NCT03435081|183213905|SUPERIORITY||Odds Ratio (OR)|3.81||||0.144|TWO_SIDED|95.0|0.63|22.85|||Regression, Logistic|||||22.85|0.63|0.144
91659551|NCT03435081|183213905|SUPERIORITY||Odds Ratio (OR)|3.1||||0.227|TWO_SIDED|95.0|0.5|19.4|||Regression, Logistic|||||19.40|0.50|0.227
91659552|NCT03435081|183213906|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|3.921||0.316|TWO_SIDED|95.0|-11.67|3.79|||Mixed Models Analysis|||||3.79|-11.67|0.316
91659553|NCT03435081|183213906|SUPERIORITY||Mean Difference (Final Values)|-11.81|STANDARD_ERROR_OF_MEAN|3.758||0.002|TWO_SIDED|95.0|-19.23|-4.4|||Mixed Models Analysis|||||-4.40|-19.23|0.002
91620348|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.8|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|95.0|-43.2|-18.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.4|-43.2|<0.001
91620349|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-32.5|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|95.0|-44.9|-20.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-20.1|-44.9|<0.001
91620350|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.9|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|95.0|-43.2|-18.7|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.7|-43.2|<0.001
91620351|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.8|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-58.0|-33.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-33.5|-58.0|<0.001
91620352|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.5|STANDARD_ERROR_OF_MEAN|5.65||0.006|TWO_SIDED|95.0|-26.7|-4.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-4.4|-26.7|0.006
91620353|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-13.2|STANDARD_ERROR_OF_MEAN|5.66||0.02|TWO_SIDED|95.0|-24.4|-2.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.1|-24.4|0.020
91620354|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.7|STANDARD_ERROR_OF_MEAN|5.67|<|0.001|TWO_SIDED|95.0|-36.8|-14.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.5|-36.8|<0.001
91620355|NCT01021852|183133792|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.0|STANDARD_ERROR_OF_MEAN|5.69|<|0.001|TWO_SIDED|95.0|-41.2|-18.8|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.8|-41.2|<0.001
91659554|NCT03435081|183213907|SUPERIORITY||Odds Ratio (OR)|1.39||||0.683|TWO_SIDED|95.0|0.29|6.78|||Regression, Logistic|||||6.78|0.29|0.683
91659555|NCT03435081|183213907|SUPERIORITY||Odds Ratio (OR)|2.25||||0.277|TWO_SIDED|95.0|0.52|9.68|||Regression, Logistic|||||9.68|0.52|0.277
91659556|NCT03435081|183213908|SUPERIORITY||Mean Difference (Final Values)|-6.02|STANDARD_ERROR_OF_MEAN|2.996||0.046|TWO_SIDED|95.0|-11.93|-0.12|||Mixed Models Analysis|||||-0.12|-11.93|0.046
91659557|NCT03435081|183213908|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|-13.46|-1.98|||Mixed Models Analysis|||||-1.98|-13.46|0.009
91659558|NCT03435081|183213909|SUPERIORITY|||||||0.598|||||||Fisher Exact|||||||0.598
91659559|NCT03435081|183213909|SUPERIORITY|||||||0.785|||||||Fisher Exact|||||||0.785
91659560|NCT03435081|183213910|SUPERIORITY||Mean Difference (Final Values)|-12.27|STANDARD_ERROR_OF_MEAN|6.562||0.063|TWO_SIDED|95.0|-25.21|0.66|||Mixed Models Analysis|||||0.66|-25.21|0.063
91659561|NCT03435081|183213910|SUPERIORITY||Mean Difference (Final Values)|-21.85|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|-34.54|-9.17|||Mixed Models Analysis|||||-9.17|-34.54|<0.001
91659562|NCT03435081|183213911|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.536||0.217|TWO_SIDED|95.0|-4.93|1.12|||Mixed Models Analysis|||||1.12|-4.93|0.217
91620356|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-10.2|STANDARD_ERROR_OF_MEAN|4.43||0.022|TWO_SIDED|95.0|-18.9|-1.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-1.5|-18.9|0.022
91620357|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.7|STANDARD_ERROR_OF_MEAN|4.44|<|0.001|TWO_SIDED|95.0|-24.5|-7.0|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-7.0|-24.5|<0.001
91620358|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-23.5|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-32.1|-14.9|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.9|-32.1|<0.001
91620359|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-20.3|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-29.0|-11.7|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-11.7|-29.0|<0.001
91620360|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.9|STANDARD_ERROR_OF_MEAN|4.61||0.055|TWO_SIDED|95.0|-18.0|0.2|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.2|-18.0|0.055
91620361|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|4.61||0.06|TWO_SIDED|95.0|-17.8|0.4|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.4|-17.8|0.060
91713345|NCT01305811|183318088|SUPERIORITY_OR_OTHER||||||=|0.22|TWO_SIDED||||||t-test, 2 sided|||In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student's t-tests at an alpha=0.05.||||=0.22
91524732|NCT01597505|182924817|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-7.2|8.3|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||8.3|-7.2|
91620362|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-19.5|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|-28.6|-10.4|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-10.4|-28.6|<0.001
91620363|NCT01021852|183133793|SUPERIORITY_OR_OTHER||Difference in LS Means|-11.3|STANDARD_ERROR_OF_MEAN|4.63||0.015|TWO_SIDED|95.0|-20.5|-2.2|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.2|-20.5|0.015
91620364|NCT01021852|183133794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-9.5|12.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||12.2|-9.5|
91620365|NCT01021852|183133794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-10.3|11.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||11.2|-10.3|
91620366|NCT01021852|183133794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|-4.2|18.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||18.3|-4.2|
91620367|NCT01021852|183133794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||||TWO_SIDED|95.0|-2.3|20.4||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||20.4|-2.3|
91620368|NCT01021852|183133795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||||TWO_SIDED|95.0|-1.0|10.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||10.2|-1.0|
91620369|NCT01021852|183133795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.6|4.8||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||4.8|-3.6|
91620370|NCT01021852|183133795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.7|6.6||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||6.6|-2.7|
91620371|NCT01021852|183133795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.5|2.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||2.3|-4.5|
91620372|NCT02130258|183133828|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
91620373|NCT02130258|183133829|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
91659563|NCT03435081|183213911|SUPERIORITY||Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|1.487||0.002|TWO_SIDED|95.0|-7.7|-1.84|||Mixed Models Analysis|||||-1.84|-7.70|0.002
91620374|NCT02130258|183133830|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||0.04
91620375|NCT01008995|183133874|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \[\<=65 kg vs \> 65 kg). The power was \>99% for both sample size assumptions.||||<0.001
91620376|NCT01008995|183133875|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
91620377|NCT01008995|183133876|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
91620378|NCT00127062|183133877|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91620379|NCT00127062|183133877|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91620380|NCT02856269|183133878|OTHER|Wilcoxon rank sum tests, X2 tests, Fisher exact tests, Kolmogorov-Smirnov|Cohen's D value|0.8|||||TWO_SIDED||||||||The Cohen's d is calculated after Box-Cox transformation. Small effect \<= 0.2, Medium effect \[0.3, 0.8\]; Large effect \>0.8|||||
91620381|NCT00547378|183133892|SUPERIORITY|||||||0.016|||||||Cochran-Mantel-Haenszel|The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups||||||0.016
91659564|NCT03435081|183213912|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.178||0.155|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.10|-0.60|0.155
91620382|NCT04633473|183133918|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.922
91620383|NCT04633473|183133919|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.521|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.521
91620384|NCT04633473|183133920|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.678|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.678
91620385|NCT04633473|183133921|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.326|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.326
91620386|NCT04633473|183133922|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.09|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.09
91620387|NCT04633473|183133923|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.154|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.154
91620388|NCT04633473|183133924|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.309|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.309
91620389|NCT04633473|183133926|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.181|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.181
91620390|NCT04633473|183133927|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.008|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.008
91620391|NCT04095286|183133989|OTHER||Ratio of adjusted geometric mean|1.03|||||TWO_SIDED|90.0|0.96|1.11|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.11|0.96|
91620392|NCT04095286|183133989|OTHER||Ratio of adjusted geometric mean|0.91|||||TWO_SIDED|90.0|0.85|0.98|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||0.98|0.85|
91620393|NCT04095286|183133992|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.09|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.09|1.02|
91620394|NCT04095286|183133992|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.08|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.00|
91620395|NCT04095286|183133993|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.08|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.02|
91620396|NCT04095286|183133993|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.01|1.07|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.07|1.01|
91620397|NCT03003403|183134021|SUPERIORITY||Risk Ratio (RR)|1.0||||0.97|TWO_SIDED|95.0|0.82|1.2|||bootstrap resampling|||||1.20|0.82|0.97
91620398|NCT03003403|183134022|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.83|TWO_SIDED|95.0|-1.24|1.0|||Mixed Models Analysis|||||1.00|-1.24|0.83
91620399|NCT03003403|183134023|SUPERIORITY|Difference in systolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.6|1.3|||Mixed Models Analysis|||||1.3|-3.6|0.34
91620400|NCT03003403|183134023|SUPERIORITY|Difference in diastolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-0.8||||0.323|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.323
91620401|NCT03003403|183134024|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.991|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||||0.8|-0.8|0.991
91620402|NCT01179347|183134056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|0.97||0.092||95.0|-0.27|3.55||Two-sided p-value.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing procedure was applied for both co-primary endpoints to maintain the overall alpha level. If and only if statistical superiority of the Tio R5 qd compared to Placebo in FEV1 AUC0-4h was demonstrated at the 1 sided alpha level of 0.025, confirmatory comparison in the second co-primary endpoint, at the same alpha level of 0.025 could be done .||3.55|-0.27|0.092
91620403|NCT01179347|183134057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15||95.0|-0.5|3.3||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful,||3.30|-0.50|0.15
91620404|NCT01179347|183134058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|0.9||0.23||95.0|-0.68|2.86||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||2.86|-0.68|0.23
91620405|NCT01179347|183134059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.93||0.19||95.0|-0.62|3.02||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||3.02|-0.62|0.19
91620406|NCT01179347|183134060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.76||0.62||95.0|-2.59|4.32||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||4.32|-2.59|0.62
91620407|NCT01179347|183134061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.092||||0.84||95.0|0.453|2.633||Two-sided p-value.|Regression, Logistic|Adjusted for treatment, age group, baseline weight and baseline FEV1 percent predicted.|Tio R5 qd versus Placebo.|||2.633|0.453|0.84
91620408|NCT03342937|183134063|SUPERIORITY|1-sided test of single exponential mean with historical null hypothesis of 5.5 months median PFS||||||0.02||||||Sample size of 35 patients was chosen based on detecting the difference between a historical median PFS of 5.5 months and experimental median of 7.3 months, a hazard ratio of 0.75, with 80% power (1-sided test of single exponential mean, α=0.2).|1-sided exponential test|||||||0.02
91620409|NCT01299610|183134068|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.38|STANDARD_ERROR_OF_MEAN|0.538||0.48|TWO_SIDED|95.0|-1.46|0.7|||Mixed model for repeated measures|||||0.70|-1.46|0.480
91527713|NCT01976364|182930499|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
91620410|NCT01299610|183134068|SUPERIORITY_OR_OTHER||mixed model for repeated measures|-0.89|STANDARD_ERROR_OF_MEAN|0.557||0.118|TWO_SIDED|95.0|-2.0|0.23|||Mixed model for repeated measures|||||0.23|-2.00|0.118
91620411|NCT01299610|183134068|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.51|STANDARD_ERROR_OF_MEAN|0.572||0.011|TWO_SIDED|95.0|-2.65|-0.36|||Mixed model for repeated measures|||||-0.36|-2.65|0.011
91620412|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.581|TWO_SIDED|95.0|-0.24|0.42|||Mixed model repeated measures|||GW870086, 0.2% cream Vs Placebo: Day 2||0.42|-0.24|0.581
91620413|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.169||0.655|TWO_SIDED|95.0|-0.42|0.27|||Mixed model repeated measures|||GW870086, 2.0% cream Vs Placebo: Day 2||0.27|-0.42|0.655
91620414|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.174||0.336||95.0|-0.52|0.18|||Mixed model repeated measures|||FP, 0.05% cream Vs Placebo: Day 2||0.18|-0.52|0.336
91620415|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.302||0.923|TWO_SIDED|95.0|-0.58|0.63|||Mixed model repeated measures|||GW870086 0.2% cream Vs Placebo: Day 3||0.63|-0.58|0.923
91620416|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.314||0.657|TWO_SIDED|95.0|-0.49|0.77|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 3||0.77|-0.49|0.657
91620417|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.323||0.386|TWO_SIDED|95.0|-0.93|0.36|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 3||0.36|-0.93|0.386
91620418|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.456||0.601|TWO_SIDED|95.0|-1.15|0.67|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 7||0.67|-1.15|0.601
91620419|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.472||0.212|TWO_SIDED|95.0|-1.54|0.35|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 7||0.35|-1.54|0.212
91620420|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.29|STANDARD_ERROR_OF_MEAN|0.485||0.01|TWO_SIDED|95.0|-2.26|-0.32|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 7||-0.32|-2.26|0.010
91620421|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.462||0.602|TWO_SIDED|95.0|-1.17|0.68|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 14||0.68|-1.17|0.602
91620422|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.65|STANDARD_ERROR_OF_MEAN|0.479||0.18|TWO_SIDED|95.0|-1.61|0.31|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 14||0.31|-1.61|0.180
91620423|NCT01299610|183134069|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.39|STANDARD_ERROR_OF_MEAN|0.492||0.006|TWO_SIDED|95.0|-2.37|-0.4|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 14||-0.40|-2.37|0.006
91620424|NCT01617655|183134079|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-51.1|-27.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-27.1|-51.1|<0.0001
91620425|NCT01617655|183134080|SUPERIORITY_OR_OTHER||LS mean difference|-38.9|||<|0.0001|TWO_SIDED|95.0|-51.0|-26.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.9|-51|<0.0001
91620426|NCT01617655|183134081|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.3|-51.4|<0.0001
91620427|NCT01617655|183134082|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-51.4|<0.0001
91620428|NCT01617655|183134083|SUPERIORITY_OR_OTHER||LS mean difference|-30.3|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.9|-39.7|<0.0001
91620429|NCT01617655|183134084|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-39.7|<0.0001
91620430|NCT01617655|183134085|SUPERIORITY_OR_OTHER||LS mean difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-46.3|-25.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.3|-46.3|<0.0001
91620431|NCT01617655|183134086|SUPERIORITY_OR_OTHER||LS mean difference|-35.5|||<|0.0001|TWO_SIDED|95.0|-46.2|-24.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.9|-46.2|<0.0001
91620432|NCT01617655|183134087|SUPERIORITY_OR_OTHER||LS mean difference|-28.4|||<|0.0001|TWO_SIDED|95.0|-37.3|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-37.3|<0.0001
91659565|NCT03435081|183213912|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.174||0.017|TWO_SIDED|95.0|-0.76|-0.07|||Mixed Models Analysis|||||-0.07|-0.76|0.017
91659566|NCT03435081|183213913|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.565||0.345|TWO_SIDED|95.0|-0.58|1.65|||Mixed Models Analysis|||Anxiety||1.65|-0.58|0.345
91524733|NCT01597505|182924818|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-3.5|||||TWO_SIDED|95.0|-10.0|3.0|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||3.0|-10.0|
91620433|NCT01617655|183134088|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.2|-21.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.1|-39.2|<0.0001
91620434|NCT01617655|183134089|SUPERIORITY_OR_OTHER||LS mean difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-44.8|-24.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.1|-44.8|<0.0001
91620435|NCT01617655|183134090|SUPERIORITY_OR_OTHER||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-36.2|-19.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.4|-36.2|<0.0001
91620436|NCT01617655|183134091|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-53.6|-24.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.6|-53.6|<0.0001
91620437|NCT01617655|183134092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.0016|TWO_SIDED|95.0|2.5|53.5||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||53.5|2.5|0.0016
91620438|NCT01617655|183134093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.9||||0.0014|TWO_SIDED|95.0|2.6|54.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||54.9|2.6|0.0014
91659567|NCT03435081|183213913|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.543||0.336|TWO_SIDED|95.0|-1.59|0.55|||Mixed Models Analysis|||Anxiety||0.55|-1.59|0.336
91620439|NCT01617655|183134094|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.8||||0.0164|TWO_SIDED|95.0|-26.9|-2.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-2.7|-26.9|0.0164
91620440|NCT01617655|183134095|SUPERIORITY_OR_OTHER||LS mean difference|3.7||||0.2745|TWO_SIDED|95.0|-2.9|10.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|-2.9|0.2745
91620441|NCT01175213|183134107|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.02|||<|0.0001|ONE_SIDED|99.0||0.045||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||||0.045||<0.0001
91620442|NCT03224585|183134131|SUPERIORITY|||||||0.0121|||||||Paired samples Wilcoxon test|||This analysis compared the change in pain scores between baseline and 6 hours||||0.0121
91620443|NCT03224585|183134132|SUPERIORITY|||||||0.0025|||||||Paired samples Wilcoxon test|||||||0.0025
91620444|NCT01921634|183134133|SUPERIORITY||Odds Ratio (OR)|1.3||||0.01|TWO_SIDED|95.0|1.1|1.7|||McNemar||The odds ratio was generated from a logistic regression model using generalized estimating equations with a logit link and represents a comparison of modified (numerator) vs standard (denominator).|||1.7|1.1|0.01
91620445|NCT00751179|183134134|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
91620446|NCT00751179|183134135|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
91620447|NCT00751179|183134137|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
91620448|NCT00751179|183134139|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
91620449|NCT04124042|183134156|SUPERIORITY||Odds Ratio (OR)|0.655|||||TWO_SIDED|95.0|0.347|1.237||||||||1.237|0.347|
91620450|NCT04124042|183134156|SUPERIORITY||Odds Ratio (OR)|0.714|||||TWO_SIDED|95.0|0.381|1.336||||||||1.336|0.381|
91713346|NCT02256696|183318106|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.12|||Regression, Cox|adjusted for age and sex at birth.||modified intention to treat (mITT) analysis||2.12|0.93|0.10
91620451|NCT04124042|183134157|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.539||0.413|TWO_SIDED|95.0|-0.62|1.5|||Mixed Models Analysis|||||1.50|-0.62|0.413
91620452|NCT04124042|183134157|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.535||0.629|TWO_SIDED|95.0|-0.79|1.31|||Mixed Models Analysis|||||1.31|-0.79|0.629
91620453|NCT04124042|183134162|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.1374|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||||1.16|-0.16|0.1374
91620454|NCT04124042|183134162|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.2807|TWO_SIDED|95.0|-0.29|1.0|||Mixed Models Analysis|||||1.00|-0.29|0.2807
91620455|NCT04124042|183134163|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.142||0.346|TWO_SIDED|95.0|-0.14|0.41|||Mixed Models Analysis|||||0.41|-0.14|0.346
91620456|NCT04124042|183134163|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.968|TWO_SIDED|95.0|-0.27|0.28|||Mixed Models Analysis|||||0.28|-0.27|0.968
91620457|NCT04124042|183134165|SUPERIORITY||Mean Difference (Final Values)|-2.83||||0.0081|TWO_SIDED|95.0|-4.91|-0.75|||Mixed Models Analysis|||Outcome measure #10 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #12 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-0.75|-4.91|0.0081
91620458|NCT04124042|183134166|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.0101|TWO_SIDED|95.0|-16.85|-2.34|||Mixed Models Analysis|||Outcome measure #11 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #13 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-2.34|-16.85|0.0101
91620459|NCT05388656|183134169|OTHER|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91620460|NCT05388656|183134170|OTHER|||||||0.0018|||||||Mixed Models Analysis|||||||0.0018
91620461|NCT05388656|183134171|OTHER|||||||0.0108|||||||Mixed Models Analysis|||||||0.0108
91620462|NCT03201965|183134172|SUPERIORITY||Odds Ratio (OR)|5.13|||<|0.0001|TWO_SIDED|95.0|3.22|8.16|||Cochran-Mantel-Haenszel|||||8.16|3.22|<0.0001
91620463|NCT03589326|183134189|SUPERIORITY||Risk Difference (RD)|0.18|||=|0.0021|TWO_SIDED|95.0|0.06|0.29||P-value is based on CMH chi-square test, with stratification according to randomization strata (age): 18 through \<45 years, ≥45 through \<60 years, and ≥60 years.|Chi-squared||Risk difference and 95% CI: adjusted percent ponatinib - adjusted percent imatinib and its 95% CI.|||0.29|0.06|=0.0021
91620464|NCT01341652|183134234|OTHER|||||||0.97|||||||Mantel Haenszel|||||||0.97
91620465|NCT01341652|183134235|SUPERIORITY|||||||0.08|||||||Wilcoxon Rank Sum test|||||||.08
91620466|NCT01341652|183134237|OTHER||Hazard Ratio (HR)|1.6||||0.14|TWO_SIDED|95.0|0.9|2.8|||Regression, Cox|||||2.8|0.9|0.14
91620467|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Neoplasm||||0.881
91620468|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Tobacco use||||0.517
91620469|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||BMI(kg/mˆ2)\>30||||0.053
91524734|NCT01597505|182924819|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.431||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.431
91524735|NCT01597505|182924820|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.011||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.011
91524736|NCT01597505|182924821|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|2.2|||||TWO_SIDED|95.0|-10.7|14.8|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||14.8|-10.7|
91527714|NCT01976364|182930499|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
91620470|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Diabetes mellitus||||0.289
91620471|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Immunosuppression/Corticosteroids||||1.000
91620472|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Anemia (Hb\<9gr/dL)||||0.169
91620473|NCT00906074|183134239|SUPERIORITY_OR_OTHER|||||||0.637|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Malnutrition (hypoalbuminemia)||||0.637
91620474|NCT00906074|183134240|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||1.000
91620475|NCT00906074|183134241|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.873
91620476|NCT00906074|183134246|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.156
91620477|NCT00906074|183134247|SUPERIORITY_OR_OTHER|||||||0.444|TWO_SIDED||||||Fisher Exact|||||||0.444
91620478|NCT04593940|183134277|SUPERIORITY||Recovery Rate Ratio|1.122||||0.0793|TWO_SIDED|95.0|0.987|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|0.987|0.0793
91620479|NCT04593940|183134277|SUPERIORITY||Recovery Rate Ratio|1.12||||0.0864|TWO_SIDED|95.0|0.984|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|.984|0.0864
91620480|NCT04593940|183134277|SUPERIORITY||Recovery Rate Ratio|1.006||||0.9354|TWO_SIDED|95.0|0.862|1.176|||Fine-Gray Proportional Hazards Model|||||1.176|0.862|0.9354
91620481|NCT04593940|183134278|SUPERIORITY||Odds Ratio (OR)|1.309||||0.0213|TWO_SIDED|95.0|1.041|1.647|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.647|1.041|0.0213
91620482|NCT04593940|183134278|SUPERIORITY||Odds Ratio (OR)|1.174||||0.1732|TWO_SIDED|95.0|0.932|1.48|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.480|0.932|0.1732
91713347|NCT02256696|183318106|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.003|TWO_SIDED|95.0|1.24|2.87|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.87|1.24|0.003
91620483|NCT04593940|183134278|SUPERIORITY||Odds Ratio (OR)|0.944||||0.6823|TWO_SIDED|95.0|0.717|1.243|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.243|0.717|0.6823
91620484|NCT04593940|183134279|SUPERIORITY||Odds Ratio (OR)|0.614||||0.0229|TWO_SIDED|95.0|0.403|0.935|||Regression, Logistic|||||0.935|0.403|0.0229
91620485|NCT04593940|183134279|SUPERIORITY||Odds Ratio (OR)|0.629||||0.0281|TWO_SIDED|95.0|0.416|0.951|||Regression, Logistic|||||0.951|0.416|0.0281
91620486|NCT04593940|183134279|SUPERIORITY||Odds Ratio (OR)|1.167||||0.541|TWO_SIDED|95.0|0.711|1.917|||Regression, Logistic|||||1.917|0.711|0.541
91620487|NCT04593940|183134280|SUPERIORITY||Odds Ratio (OR)|1.435||||0.0032|TWO_SIDED|95.0|1.129|1.825|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.825|1.129|0.0032
91620488|NCT04593940|183134280|SUPERIORITY||Odds Ratio (OR)|1.338||||0.0228|TWO_SIDED|95.0|1.041|1.718|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.718|1.041|0.0228
91620489|NCT04593940|183134280|SUPERIORITY||Odds Ratio (OR)|0.904||||0.4994|TWO_SIDED|95.0|0.675|1.211|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.211|0.675|0.4994
91620490|NCT04593940|183134281|SUPERIORITY||Odds Ratio (OR)|0.632||||0.0988|TWO_SIDED|95.0|0.367|1.09|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.090|0.367|0.0988
91620491|NCT04593940|183134281|SUPERIORITY||Odds Ratio (OR)|0.552||||0.0354|TWO_SIDED|95.0|0.317|0.96|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||0.960|0.317|0.0354
91620492|NCT04593940|183134281|SUPERIORITY||Odds Ratio (OR)|1.287||||0.4132|TWO_SIDED|95.0|0.703|2.355|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||2.355|0.703|0.4132
91620493|NCT04593940|183134282|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.1601|TWO_SIDED|95.0|1.0|1.28|||Fine-Gray Proportional Hazards Model|||||1.28|1.00|0.1601
91620494|NCT04593940|183134282|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.355|TWO_SIDED|95.0|0.97|1.24|||Fine-Gray Proportional Hazards Model|||||1.24|0.97|0.3550
91620495|NCT04593940|183134282|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2386|TWO_SIDED|95.0|0.8|1.07|||Fine-Gray Proportional Hazards Model|||||1.07|0.80|0.2386
91620496|NCT04593940|183134283|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1519|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.1519
91620497|NCT04593940|183134283|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.2605|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.2605
91620498|NCT04593940|183134283|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4359|TWO_SIDED|95.0|0.83|1.13|||Fine-Gray Proportional Hazards Model|||||1.13|0.83|0.4359
91713348|NCT02256696|183318106|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.09|TWO_SIDED|95.0|0.95|2.15|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.15|0.95|0.09
91524737|NCT01597505|182924822|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-2.4|||||TWO_SIDED|95.0|-7.8|3.0|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||3.0|-7.8|
91620499|NCT04593940|183134284|SUPERIORITY||Mean Difference (Net)|-0.06||||0.321|TWO_SIDED|95.0|-0.18|0.06|||t-test, 2 sided|||||0.06|-0.18|0.3210
91620500|NCT04593940|183134284|SUPERIORITY||Mean Difference (Net)|0.04||||0.5275|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|||||0.17|-0.09|0.5275
91620501|NCT04593940|183134284|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.15|0.15|||t-test, 2 sided|||||0.15|-0.15|0.9993
91620502|NCT04593940|183134285|SUPERIORITY||Mean Difference (Net)|0.07||||0.4982|TWO_SIDED|95.0|-0.13|0.26|||t-test, 2 sided|||||0.26|-0.13|0.4982
91620503|NCT04593940|183134285|SUPERIORITY||Mean Difference (Net)|0.09||||0.3491|TWO_SIDED|95.0|-0.1|0.29|||t-test, 2 sided|||||0.29|-0.10|0.3491
91620504|NCT04593940|183134285|SUPERIORITY||Mean Difference (Net)|-0.01||||0.902|TWO_SIDED|95.0|-0.25|0.22|||t-test, 2 sided|||||0.22|-0.25|0.9020
91620505|NCT04593940|183134286|SUPERIORITY||Mean Difference (Net)|0.24||||0.0842|TWO_SIDED|95.0|-0.03|0.52|||t-test, 2 sided|||||0.52|-0.03|0.0842
91659568|NCT03435081|183213913|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.465||0.353|TWO_SIDED|95.0|-0.48|1.35|||Mixed Models Analysis|||Depression||1.35|-0.48|0.353
91659569|NCT03435081|183213913|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.446||0.34|TWO_SIDED|95.0|-1.31|0.45|||Mixed Models Analysis|||Depression||0.45|-1.31|0.340
91620506|NCT04593940|183134286|SUPERIORITY||Mean Difference (Net)|0.09||||0.5328|TWO_SIDED|95.0|-0.19|0.37|||t-test, 2 sided|||||0.37|-0.19|0.5328
91620507|NCT04593940|183134286|SUPERIORITY||Mean Difference (Net)|-0.12||||0.4727|TWO_SIDED|95.0|-0.46|0.21|||t-test, 2 sided|||||0.21|-0.46|0.4727
91620508|NCT04593940|183134287|SUPERIORITY||Mean Difference (Net)|0.31||||0.0399|TWO_SIDED|95.0|0.01|0.61|||t-test, 2 sided|||||0.61|0.01|0.0399
91620509|NCT04593940|183134287|SUPERIORITY||Mean Difference (Net)|0.11||||0.4515|TWO_SIDED|95.0|-0.18|0.41|||t-test, 2 sided|||||0.41|-0.18|0.4515
91620510|NCT04593940|183134287|SUPERIORITY||Mean Difference (Net)|-0.07||||0.696|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided|||||0.29|-0.43|0.6960
91620511|NCT04593940|183134288|SUPERIORITY||Mean Difference (Net)|0.26||||0.0903|TWO_SIDED|95.0|-0.04|0.57|||t-test, 2 sided|||||0.57|-0.04|0.0903
91620512|NCT04593940|183134288|SUPERIORITY||Mean Difference (Net)|0.15||||0.348|TWO_SIDED|95.0|-0.16|0.45|||t-test, 2 sided|||||0.45|-0.16|0.3480
91620513|NCT04593940|183134288|SUPERIORITY||Mean Difference (Net)|-0.07||||0.6984|TWO_SIDED|95.0|-0.44|0.29|||t-test, 2 sided|||||0.29|-0.44|0.6984
91620514|NCT04593940|183134289|SUPERIORITY||Mean Difference (Net)|0.32||||0.045|TWO_SIDED|95.0|0.01|0.62|||t-test, 2 sided|||||0.62|0.01|0.0450
91620515|NCT04593940|183134289|SUPERIORITY||Mean Difference (Net)|0.19||||0.2462|TWO_SIDED|95.0|-0.13|0.5|||t-test, 2 sided|||||0.50|-0.13|0.2462
91620516|NCT04593940|183134289|SUPERIORITY||Mean Difference (Net)|-0.23||||0.2304|TWO_SIDED|95.0|-0.61|0.15|||t-test, 2 sided|||||0.15|-0.61|0.2304
91620517|NCT04593940|183134290|SUPERIORITY||Mean Difference (Net)|0.35||||0.0313|TWO_SIDED|95.0|0.03|0.66|||t-test, 2 sided|||||0.66|0.03|0.0313
91620518|NCT04593940|183134290|SUPERIORITY||Mean Difference (Net)|0.31||||0.0555|TWO_SIDED|95.0|-0.01|0.63|||t-test, 2 sided|||||0.63|-0.01|0.0555
91620519|NCT04593940|183134290|SUPERIORITY||Mean Difference (Net)|-0.22||||0.271|TWO_SIDED|95.0|-0.6|0.17|||t-test, 2 sided|||||0.17|-0.60|0.2710
91659570|NCT03435081|183213914|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.228||0.224|TWO_SIDED|95.0|-3.92|0.92|||Mixed Models Analysis|||||0.92|-3.92|0.224
91659571|NCT03435081|183213914|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.184||0.004|TWO_SIDED|95.0|-5.83|-1.16|||Mixed Models Analysis|||||-1.16|-5.83|0.004
91713349|NCT02256696|183318106|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.005|TWO_SIDED|95.0|1.21|2.89|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.89|1.21|0.005
91713350|NCT02256696|183318109|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.02|TWO_SIDED|95.0|1.07|2.44|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.44|1.07|0.02
91713351|NCT02256696|183318109|SUPERIORITY||Hazard Ratio (HR)|1.8||||0.006|TWO_SIDED|95.0|1.18|2.75|||Regression, Cox|adjusted for age and sex at birth||mITT analysis||2.75|1.18|0.006
91713352|NCT02256696|183318109|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.03|TWO_SIDED|95.0|1.05|2.42|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.42|1.05|0.03
91524738|NCT01597505|182924823|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|14.6|||||TWO_SIDED|95.0|-2.7|30.7|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||30.7|-2.7|
91659572|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|5.956||0.575|TWO_SIDED|95.0|-15.3|8.57|||Mixed Models Analysis|||Absenteeism Change from Baseline||8.57|-15.30|0.575
91659573|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|5.664||0.851|TWO_SIDED|95.0|-12.43|10.3|||Mixed Models Analysis|||Absenteeism Change from Baseline||10.30|-12.43|0.851
91659574|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-11.75|STANDARD_ERROR_OF_MEAN|5.212||0.026|TWO_SIDED|95.0|-22.05|-1.45|||Mixed Models Analysis|||Presenteeism Change from Baseline||-1.45|-22.05|0.026
91659575|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|5.056||0.002|TWO_SIDED|95.0|-25.89|-5.91|||Mixed Models Analysis|||Presenteeism Change from Baseline||-5.91|-25.89|0.002
91659576|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-12.85|STANDARD_ERROR_OF_MEAN|6.237||0.041|TWO_SIDED|95.0|-25.18|-0.51|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-0.51|-25.18|0.041
91659577|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-16.27|STANDARD_ERROR_OF_MEAN|6.034||0.008|TWO_SIDED|95.0|-28.2|-4.34|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-4.34|-28.20|0.008
91659578|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.219||0.023|TWO_SIDED|95.0|-17.95|-1.32|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-1.32|-17.95|0.023
91659579|NCT03435081|183213915|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|4.115||0.001|TWO_SIDED|95.0|-21.4|-5.17|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-5.17|-21.40|0.001
91659580|NCT03435081|183213916|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026||0.482|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.07|-0.03|0.482
91659581|NCT03435081|183213916|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.043|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.10|0.00|0.043
91659582|NCT03435081|183213916|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.656|TWO_SIDED|95.0|-0.06|0.09|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.09|-0.06|0.656
91659583|NCT03435081|183213916|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.036||0.057|TWO_SIDED|95.0|0.0|0.14|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.14|-0.00|0.057
91659584|NCT03435081|183213917|SUPERIORITY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|2.597||0.609|TWO_SIDED|95.0|-6.45|3.79|||Mixed Models Analysis|||||3.79|-6.45|0.609
91659585|NCT03435081|183213917|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.503||0.166|TWO_SIDED|95.0|-1.46|8.41|||Mixed Models Analysis|||||8.41|-1.46|0.166
91659586|NCT03435081|183213918|SUPERIORITY||Odds Ratio (OR)|1.96||||0.258|TWO_SIDED|95.0|0.61|6.26|||Regression, Logistic|||||6.26|0.61|0.258
91659587|NCT03435081|183213918|SUPERIORITY||Odds Ratio (OR)|2.99||||0.052|TWO_SIDED|95.0|0.99|8.97|||Regression, Logistic|||||8.97|0.99|0.052
91659588|NCT02601560|183213923|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANCOVA|||||||0.095
91659589|NCT02601560|183213923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91659590|NCT02601560|183213923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91659591|NCT02601560|183213923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91659592|NCT02601560|183213923|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||||||0.440
91659593|NCT02601560|183213923|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91659594|NCT00420238|183213957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.019|TWO_SIDED|95.0|-16.5|-1.51|||ANCOVA||Least squares mean difference = mean difference final value.|Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.||-1.51|-16.5|0.019
91659595|NCT00420238|183213958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.098|TWO_SIDED|95.0|0.82|10.42|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||10.42|0.82|0.098
91659596|NCT00420238|183213958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.197|TWO_SIDED|95.0|0.69|5.88|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.88|0.69|0.197
91659597|NCT00420238|183213958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.89|5.95|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.95|0.89|0.087
91659598|NCT00420238|183213958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.83||||0.031|TWO_SIDED|95.0|1.1|7.29|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||7.29|1.10|0.031
91713353|NCT02256696|183318109|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.007|TWO_SIDED|95.0|1.18|2.85|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.85|1.18|0.007
91620520|NCT04593940|183134291|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
91620521|NCT04593940|183134291|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.6||||||||1.6|-0.5|
91620522|NCT04593940|183134291|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.8|0.7||||||||0.7|-1.8|
91713354|NCT00382785|183318132|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|95.0|||||univariate analysis|||Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).||||.315
91713355|NCT00382785|183318133|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||univariate analysis|Null Hypothesis: There will be no difference between the moderated and peer-led groups based on type of online support (moderated; peer-led)||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).||||.23
91791861|NCT01931670|183461158|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|0.738||0.002|TWO_SIDED|95.0|-3.73|-0.83|||ANCOVA|||Month 6||-0.83|-3.73|0.002
91659599|NCT00420238|183213959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.62|4.57|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.57|0.62|0.310
91659600|NCT00420238|183213959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.309|TWO_SIDED|95.0|0.65|3.99|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||3.99|0.65|0.309
91659601|NCT00420238|183213959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61||||0.001|TWO_SIDED|95.0|1.81|11.74|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.74|1.81|0.001
91659602|NCT00420238|183213959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14||||0.003||95.0|1.65|10.42|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||10.42|1.65|0.003
91659603|NCT00420238|183213961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.259|TWO_SIDED|95.0|0.57|7.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||7.94|0.57|0.259
91659604|NCT00420238|183213961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.44||95.0|0.51|4.64|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.64|0.51|0.440
91659605|NCT00420238|183213961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.046||95.0|1.02|8.16|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||8.16|1.02|0.046
91659606|NCT00420238|183213961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85||||0.014||95.0|1.31|11.32|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.32|1.31|0.014
91713356|NCT00382785|183318134|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Univariate Analysis|||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).||||.32
91713357|NCT03066830|183318174|SUPERIORITY||Difference in Least Square (LS) Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.946|-0.574|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.574|-0.946|< 0.0001
91620523|NCT04593940|183134292|SUPERIORITY||Difference in percentages|29.2|||||TWO_SIDED|95.0|-0.4|53.7||||||||53.7|-0.4|
91620524|NCT04593940|183134292|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|-14.8|40.0||||||||40.0|-14.8|
91620525|NCT04593940|183134292|SUPERIORITY||Difference in percentages|-5.8|||||TWO_SIDED|95.0|-38.7|26.6||||||||26.6|-38.7|
91620526|NCT04593940|183134293|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.2|2.3||||||||2.3|0.2|
91620527|NCT04593940|183134293|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|2.0||||||||2.0|-0.1|
91620528|NCT04593940|183134293|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.0|0.6||||||||0.6|-2.0|
91620529|NCT04593940|183134294|SUPERIORITY||Difference in percentages|-7.0|||||TWO_SIDED|95.0|-14.0|0.0||||||||0.0|-14.0|
91620530|NCT04593940|183134294|SUPERIORITY||Difference in percentages|-3.9|||||TWO_SIDED|95.0|-11.1|3.4||||||||3.4|-11.1|
91620531|NCT04593940|183134294|SUPERIORITY||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-10.1|8.1||||||||8.1|-10.1|
91620532|NCT04593940|183134295|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|1.8||||||||1.8|-0.1|
91620533|NCT04593940|183134295|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||||1.7|-0.3|
91791862|NCT01249118|183461191|SUPERIORITY_OR_OTHER||Ratio of LS Means|8.45|||||TWO_SIDED|90.0|7.08|10.08|||||The 90 percent (%) confidence intervals (CI) of test group (oral dose) means relative to reference group (IV dose) means were obtained by taking antilog of corresponding 90% CI for the differences between the means on the log scale.|Least squares (LS) mean was calculated from analysis of variance (ANOVA). Data for dose-normalized Cmax were natural log-transformed prior to analysis.||10.08|7.08|
91791863|NCT01249118|183461195|SUPERIORITY_OR_OTHER||Ratio of LS Means|48.6|||||TWO_SIDED|90.0|41.43|56.94|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS means was calculated from ANOVA. Data for dose-normalized AUC (0 - t) were natural log-transformed prior to analysis.||56.94|41.43|
91791864|NCT01249118|183461197|SUPERIORITY_OR_OTHER||Ratio of LS Means|45.9|||||TWO_SIDED|90.0|39.74|53.06|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS mean was calculated from ANOVA. Data for dose-normalized AUC (0 - ∞) were natural log-transformed prior to analysis.||53.06|39.74|
91791865|NCT01063712|183461227|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|||It is not a analysis of two groups. Only one group of patients was analyzed.||||<0.01
91791866|NCT01063712|183461228|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|The analysis was made on the basis of the percentage of patients with completely regressed dilation.||It is a one arm clinical study. No comparison between groups was made.||||<0.01
91791867|NCT05033002|183461295|SUPERIORITY||Slope|-0.41|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||<.0001
91791868|NCT05033002|183461295|SUPERIORITY||Slope|0.002|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||<.0001
91791869|NCT05033002|183461296|SUPERIORITY||Slope|0.06||||0.002|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.002
91791870|NCT05033002|183461296|SUPERIORITY||Slope|-0.0003||||0.01|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.010
91791871|NCT05033002|183461297|SUPERIORITY||Slope|0.05||||0.001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.001
91791872|NCT05033002|183461297|SUPERIORITY||Slope|-0.0002||||0.032|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.032
91791873|NCT05033002|183461298|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.506|TWO_SIDED||||||t-test, 2 sided|||||||0.506
91791874|NCT05033002|183461299|SUPERIORITY|||||||0.441||||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis|The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.||||||.441
91791875|NCT05033002|183461299|SUPERIORITY||Slope|0.0002||||0.734|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.734
91620534|NCT04593940|183134295|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-2.0|0.4||||||||0.4|-2.0|
91791876|NCT00329901|183461314|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|9.0|||||TWO_SIDED|95.0|5.0|14.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline||14|5|
91791877|NCT00329901|183461314|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo||2|-1|
91620535|NCT04593940|183134296|SUPERIORITY||Difference in percentages|-1.1|||||TWO_SIDED|95.0|-5.7|3.5||||||||3.5|-5.7|
91620536|NCT04593940|183134296|SUPERIORITY||Difference in percentages|-1.3|||||TWO_SIDED|95.0|-6.0|3.3||||||||3.3|-6.0|
91620537|NCT04593940|183134296|SUPERIORITY||Difference in percentages|2.2|||||TWO_SIDED|95.0|-3.7|8.0||||||||8.0|-3.7|
91620538|NCT04593940|183134297|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
91620539|NCT04593940|183134297|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.7|1.4||||||||1.4|-0.7|
91620540|NCT04593940|183134297|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||||1.1|-1.3|
91620541|NCT04593940|183134298|SUPERIORITY||Hazard Ratio (HR)|0.878||||0.3169|TWO_SIDED|95.0|0.68|1.133|||Log Rank|||||1.133|0.680|0.3169
91713358|NCT03066830|183318175|SUPERIORITY||Difference in LS Means|-1.608|STANDARD_ERROR_OF_MEAN|0.286|<|0.0001|TWO_SIDED|95.0|-2.1685|-1.0471|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-1.0471|-2.1685|< 0.0001
91620542|NCT04593940|183134298|SUPERIORITY||Hazard Ratio (HR)|0.863||||0.248|TWO_SIDED|95.0|0.672|1.108|||Log Rank|||||1.108|0.672|0.2480
91620543|NCT04593940|183134298|SUPERIORITY||Hazard Ratio (HR)|1.191||||0.249|TWO_SIDED|95.0|0.885|1.604|||Log Rank|||||1.604|0.885|0.2490
91620544|NCT04593940|183134299|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.5175|TWO_SIDED|95.0|0.85|1.38|||Log Rank|||||1.380|0.850|0.5175
91620545|NCT04593940|183134299|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.5216|TWO_SIDED|95.0|0.722|1.179|||Log Rank|||||1.179|0.722|0.5216
91620546|NCT04593940|183134299|SUPERIORITY||Hazard Ratio (HR)|1.075||||0.6135|TWO_SIDED|95.0|0.812|1.424|||Log Rank|||||1.424|0.812|0.6135
91620547|NCT04593940|183134300|SUPERIORITY||Hazard Ratio (HR)|0.565||||0.3628|TWO_SIDED|95.0|0.165|1.931|||Log Rank|||||1.931|0.165|0.3628
91620548|NCT04593940|183134300|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.3701|TWO_SIDED|95.0|0.167|1.948|||Log Rank|||||1.948|0.167|0.3701
91620549|NCT04593940|183134300|SUPERIORITY||Hazard Ratio (HR)|4.988||||0.0001|TWO_SIDED|95.0|2.211|11.251|||Log Rank|||||11.251|2.211|0.0001
91659607|NCT00420238|183213963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.204|TWO_SIDED|95.0|0.55|16.53|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||16.53|0.55|0.204
91659608|NCT00420238|183213963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
91659609|NCT00420238|183213963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.73||||0.121||95.0|0.71|19.69|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||19.69|0.71|0.121
91659610|NCT00420238|183213963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.058||95.0|0.96|11.8|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.80|0.96|0.058
91659611|NCT00420238|183213965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5||||0.287|TWO_SIDED|95.0|0.35|35.14|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||35.14|0.35|0.287
91659612|NCT00420238|183213965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.169||95.0|0.51|44.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||44.94|0.51|0.169
91659613|NCT00420238|183213965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
91659614|NCT00420238|183213965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
91659615|NCT00420238|183213967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95||||0.018|TWO_SIDED|95.0|-18.19|-1.72|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-1.72|-18.19|0.018
91659616|NCT00420238|183213968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.54||||0.089|TWO_SIDED|95.0|-18.4|1.33|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.33|-18.40|0.089
91620550|NCT04146467|183134337|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91620551|NCT04146467|183134339|SUPERIORITY||||||<|0.0004|||||||Fisher Exact|||||||<0.0004
91620552|NCT04146467|183134347|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91620553|NCT02128763|183134352|SUPERIORITY|||||||0.4|TWO_SIDED|95.0||||P value refers to difference between group on change in overall OSDI score (Row 1).|Regression, Linear|||||||0.40
91620554|NCT02128763|183134353|SUPERIORITY|||||||0.09|TWO_SIDED|95.0|||||Regression, Linear|||||||0.09
91620555|NCT02128763|183134354|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|Pos hoc application of the Benjamini-Hochberg adjustment||||||0.77
91620556|NCT02128763|183134355|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
91620557|NCT02128763|183134356|SUPERIORITY|||||||0.051|TWO_SIDED|95.0|||||Regression, Linear|||||||0.051
91620558|NCT02128763|183134357|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
91620559|NCT02128763|183134358|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
91659617|NCT00420238|183213968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.11||95.0|-17.89|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-17.89|0.110
91722431|NCT04190225|183337487|SUPERIORITY||Median Difference (Final Values)|18.4||||0.04|TWO_SIDED|95.0|4.67|37.28|||quantile regression||Median difference is not the difference in the two medians, but is the median of differences between groups (why it is 18.4 and not 23)|||37.28|4.67|0.04
91620560|NCT02128763|183134359|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||Regression, Linear|||||||0.40
91620561|NCT02128763|183134360|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|||||||0.77
91620562|NCT02128763|183134361|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
91620563|NCT02128763|183134362|SUPERIORITY|||||||0.25|TWO_SIDED|95.0|||||Regression, Linear|||||||0.25
91620564|NCT02128763|183134363|SUPERIORITY|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||0.61
91620565|NCT02128763|183134364|SUPERIORITY|||||||0.42|TWO_SIDED|95.0|||||Regression, Linear|||||||0.42
91620566|NCT02128763|183134365|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Chi-squared, Corrected|||||||0.60
91620567|NCT02128763|183134366|SUPERIORITY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||0.17
91620568|NCT02128763|183134367|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
91620569|NCT02128763|183134368|SUPERIORITY|||||||0.71|TWO_SIDED|95.0|||||Regression, Linear|||||||0.71
91620570|NCT02128763|183134369|SUPERIORITY|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
91620571|NCT02128763|183134370|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
91620572|NCT01934192|183134384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
91620573|NCT01934192|183134385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|-6.5|10.9||||||||10.9|-6.5|
91620574|NCT01934192|183134386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
91620575|NCT01934192|183134387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|6.74|||TWO_SIDED|95.0|-6.9|19.9||||||||19.9|-6.9|
91620576|NCT04105244|183134452|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
91620577|NCT04105244|183134453|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
91620578|NCT04105244|183134454|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
91620579|NCT04105244|183134457|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
91620580|NCT04105244|183134458|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91659618|NCT00420238|183213968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73||||0.004||95.0|-24.6|-4.86|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.86|-24.60|0.004
91659619|NCT00420238|183213968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.27||||0.065||95.0|-19.14|0.59|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||0.59|-19.14|0.065
91620581|NCT00099359|183134472|SUPERIORITY_OR_OTHER|||||||0.046||||||Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.|multiple comparison|Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms.||||||.046
91620582|NCT00099359|183134473|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||.0001
91620583|NCT00099359|183134474|SUPERIORITY_OR_OTHER|||||||0.2432|||||||multiple comparison|||||||.2432
91620584|NCT00099359|183134475|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
91620585|NCT00099359|183134478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.05|TWO_SIDED|95.0|0.24|1.01|||Regression, Logistic|Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group||||1.01|0.24|0.05
91620586|NCT00099359|183134478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.01|TWO_SIDED|95.0|0.19|0.82||Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.|Regression, Logistic|||||0.82|0.19|0.01
91620587|NCT00099359|183134478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.03|TWO_SIDED|95.0|1.08|5.86|||Regression, Logistic|"Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with NO being reference group."||||5.86|1.08|0.03
91620588|NCT00099359|183134478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.56|3.35||Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status|Regression, Logistic|||||3.35|1.56|<0.0001
91620589|NCT02104804|183134493|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.72|-0.45|||ANCOVA|||||-0.45|-0.72|<0.001
91620590|NCT02104804|183134494|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6133.2|STANDARD_ERROR_OF_MEAN|781.06|<|0.001|TWO_SIDED|95.0|-7668.5|-4597.9|||ANCOVA|||||-4597.9|-7668.5|<0.001
91620591|NCT02104804|183134495|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-39.11|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-49.41|-28.82|||ANCOVA|||||-28.82|-49.41|<0.001
91620592|NCT02104804|183134496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8||||0.002|TWO_SIDED|95.0|3.1|12.6|||Difference in proportions|||||12.6|3.1|0.002
91620593|NCT02104804|183134497|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.88|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-21.53|-10.22|||ANCOVA|||||-10.22|-21.53|<0.001
91620594|NCT02104804|183134498|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19|||ANCOVA|||||0.19|-0.44|0.430
91620595|NCT00406783|183134501|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91620596|NCT00406783|183134502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91620597|NCT01337167|183134572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|9.68|||<|0.001|TWO_SIDED|95.0|4.83|14.83|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1.0 μg/mL||14.83|4.83|<0.001
91620598|NCT01337167|183134572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
91620599|NCT01337167|183134572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419-Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Secondary Analysis: Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
91620600|NCT01337167|183134573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|0.84|||<|0.001|TWO_SIDED|95.0|-0.35|2.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.74|-0.35|<0.001
91713359|NCT03066830|183318176|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|1.272||0.5172|TWO_SIDED|95.0|-3.316|1.669|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening and country as fixed effects, and baseline SBP as a covariate.||1.669|-3.316|0.5172
91713360|NCT03066830|183318177|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.983||0.2994|TWO_SIDED|95.0|-2.946|0.907|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥ 30 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.907|-2.946|0.2994
91722432|NCT04190225|183337488|SUPERIORITY||Median Difference (Final Values)|23.5||||0.03|TWO_SIDED|95.0|8.35|32.76|||quantile regression|||||32.76|8.35|0.03
91620601|NCT01337167|183134574|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-3.84||||0.002|TWO_SIDED|95.0|-8.02|0.66|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||0.66|-8.02|0.002
91620602|NCT01337167|183134575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.39|||<|0.001|TWO_SIDED|95.0|-0.28|1.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.74|-0.28|<0.001
91620603|NCT01337167|183134576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.33|||<|0.001|TWO_SIDED|95.0|-1.8|1.6|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.60|-1.80|<0.001
91620604|NCT01337167|183134577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-4.7||||0.001|TWO_SIDED|95.0|-8.14|-0.97|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.97|-8.14|0.001
91620605|NCT01337167|183134578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-2.67|||<|0.001|TWO_SIDED|95.0|-7.27|2.23|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.23|-7.27|<0.001
91620606|NCT01337167|183134579|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|4.05|||<|0.001|TWO_SIDED|95.0|0.23|8.28|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.28|0.23|<0.001
91620607|NCT01337167|183134580|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|1.76|||<|0.001|TWO_SIDED|95.0|0.85|3.59|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.59|0.85|<0.001
91620608|NCT01337167|183134580|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
91620609|NCT01337167|183134581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.26|||<|0.001|TWO_SIDED|95.0|-0.22|1.42|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.42|-0.22|<0.001
91722433|NCT04190225|183337489|SUPERIORITY||||||<|0.001|||||||quantile regression|||||||<.001
91659620|NCT00420238|183213970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.99||||0.002|TWO_SIDED|95.0|-17.7|-4.28|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-4.28|-17.70|0.002
91713361|NCT03066830|183318178|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED|95.0|-1.932|-0.884|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.884|-1.932|< 0.0001
91713362|NCT03066830|183318179|SUPERIORITY||Percentage difference|6.7||||0.0004|TWO_SIDED|95.0|3.03|10.47|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130,≥130 mmHg) at screening, randomization strata of metformin use at the screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||10.47|3.03|0.0004
91713363|NCT03066830|183318180|SUPERIORITY||Percentage difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.16|23.73|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization strata of Metformin use at screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||23.73|11.16|< 0.0001
91713364|NCT03705286|183318217|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.87||0.78|TWO_SIDED|95.0|-4.21|3.17|||Regression, Linear|||We evaluated whether there are differences in the Physical Component Score (PCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||3.17|-4.21|0.78
91713365|NCT03705286|183318217|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.05||0.15|TWO_SIDED|95.0|-7.03|1.07|||Regression, Linear|||We evaluated whether there are differences in the Mental Component Score (MCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||1.07|-7.03|0.15
91713366|NCT03705286|183318218|SUPERIORITY||Risk Difference (RD)|0.05||||0.05|TWO_SIDED|98.0|-0.07|0.17|||Regression, Logistic|||||0.17|-0.07|0.05
91713367|NCT03705286|183318219|SUPERIORITY||Risk Difference (RD)|0.126||||0.05|TWO_SIDED|95.0|-0.01|0.26|||Regression, Logistic|||We evaluated whether there are differences in the risk of laryngeal injury between the PU-EVAC and PVC treatment groups, comparing their respective risk difference (i.e., probability\[PU-EVAC\] - probability \[PVC\]). We fit a logistic regression model and incorporated robust (i.e., Huber-White heteroskedastic consistent) standard error estimates for our hypothesis test and 95% confidence interval estimates.||0.26|-0.01|0.05
91713368|NCT00593450|183318222|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-3.9|2.9||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.9|-3.9|0.16
91713369|NCT00593450|183318222|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.16|TWO_SIDED|99.2|-4.1|2.4||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.4|-4.1|0.16
91722434|NCT00884065|183337490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|4.08|>|0.05|TWO_SIDED|95.0|-9.93|6.49|||t-test, 2 sided|||||6.49|-9.93|>0.05
91659621|NCT00420238|183213971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33||||0.054|TWO_SIDED|95.0|-16.81|0.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||0.15|-16.81|0.054
91524739|NCT01597505|182924824|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|4.3|||||TWO_SIDED|95.0|-4.2|12.7|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||12.7|-4.2|
91659622|NCT00420238|183213971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02||||0.011||95.0|-19.5|-2.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.54|-19.50|0.011
91659623|NCT00420238|183213971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.75||||0.003||95.0|-21.23|-4.27|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.27|-21.23|0.003
91659624|NCT00420238|183213971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.29|||<|0.001||95.0|-23.7|-6.82|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-6.82|-23.7|<0.001
91659625|NCT00420238|183213973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59||||0.039|TWO_SIDED|95.0|-18.69|-0.49|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.49|-18.69|0.039
91659626|NCT00420238|183213974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28||||0.254|TWO_SIDED|95.0|-17.13|4.57|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.57|-17.13|0.254
91659627|NCT00420238|183213974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.348||95.0|-16.02|5.68|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.68|-16.02|0.348
91659628|NCT00420238|183213974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.72||||0.014||95.0|-24.57|-2.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.88|-24.57|0.014
91524740|NCT05652036|182924872|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NPS score pre- and post-procedure||||0.21
91524741|NCT05652036|182924873|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder symptom bother before and after treatment||||.07
91524742|NCT05652036|182924873|OTHER|||||||0.16||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder HRQL mean before and after treatment||||0.16
91524743|NCT05652036|182924874|OTHER|||||||0.21|||||||Chi-squared|||Participant rated procedural satisfaction assessed 30-days post-procedure.||||0.21
91524744|NCT05652036|182924875|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as very much improved after treatment||||||0.79|||||||Chi-squared|||||||0.79
91524745|NCT05652036|182924875|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as much improved after treatment||||||0.27|||||||Chi-squared|||||||0.27
91659629|NCT00420238|183213974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.001||95.0|-30.54|-8.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-8.84|-30.54|<0.001
91659630|NCT00420238|183213976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49||||0.071|TWO_SIDED|95.0|-17.73|0.75|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.75|-17.73|0.071
91659631|NCT00420238|183213977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57||||0.511|TWO_SIDED|95.0|-14.31|7.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.17|-14.31|0.511
91659632|NCT00420238|183213977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.57||||0.401||95.0|-15.31|6.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||6.17|-15.31|0.401
91659633|NCT00420238|183213977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.45||||0.023||95.0|-23.19|-1.71|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-1.71|-23.19|0.023
91659634|NCT00420238|183213977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.25||||0.01||95.0|-24.99|-3.51|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.51|-24.99|0.010
91722435|NCT00884065|183337491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.01||95.0|5.72|17.08|||t-test, 2 sided|||||17.08|5.72|<0.01
91722436|NCT00884065|183337492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.24|STANDARD_ERROR_OF_MEAN|2.59|<|0.01|TWO_SIDED|95.0|2.03|12.45|||t-test, 2 sided|||||12.45|2.03|<0.01
91722437|NCT00884065|183337493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.72|>|0.05|TWO_SIDED|95.0|-1.53|5.37|||t-test, 2 sided|||||5.37|-1.53|>0.05
91722438|NCT00884065|183337494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.18|>|0.05|TWO_SIDED|95.0|-3.81|5.01|||t-test, 2 sided|||||5.01|-3.81|>0.05
91620610|NCT01337167|183134581|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
91620611|NCT01337167|183134582|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.25|||<|0.001|TWO_SIDED|95.0|-0.24|1.41|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.41|-0.24|<0.001
91620612|NCT01337167|183134582|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.53|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.53|<0.001
91620613|NCT01337167|183134583|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.2|1.38|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.38|1.20|<0.001
91620614|NCT01337167|183134584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.64||||0.786|TWO_SIDED|95.0|0.59|0.7|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.70|0.59|0.786
91620615|NCT01337167|183134585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.73|<0.001
91620616|NCT01337167|183134586|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.15|1.42|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.42|1.15|<0.001
91620617|NCT01337167|183134587|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.88|||<|0.001|TWO_SIDED|95.0|0.39|4.18|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.18|0.39|<0.001
91620618|NCT01337167|183134588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.3|||<|0.001|TWO_SIDED|95.0|-1.67|4.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.78|-1.67|<0.001
91620619|NCT01337167|183134589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.41|||<|0.001|TWO_SIDED|95.0|-3.46|3.1|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.10|-3.46|<0.001
91620620|NCT01337167|183134590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|6.18|||<|0.001|TWO_SIDED|95.0|3.26|9.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||9.78|3.26|<0.001
91620621|NCT01337167|183134591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.4|||<|0.001|TWO_SIDED|95.0|1.28|1.52|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.52|1.28|<0.001
91620622|NCT01337167|183134592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.10|0.91|<0.001
91620623|NCT01337167|183134593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.78||||0.014|TWO_SIDED|95.0|0.68|0.89|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.89|0.68|0.014
91620624|NCT01337167|183134594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.58|||<|0.001|TWO_SIDED|95.0|1.41|1.78|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.78|1.41|<0.001
91620625|NCT01337167|183134595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.62|||<|0.001|TWO_SIDED|95.0|1.32|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.32|<0.001
91620626|NCT01337167|183134596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.02|||<|0.001|TWO_SIDED|95.0|0.83|1.24|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.24|0.83|<0.001
91722439|NCT00884065|183337495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.08|STANDARD_ERROR_OF_MEAN|1.49|<|0.01|TWO_SIDED|95.0|0.08|6.09|||t-test, 2 sided|||||6.09|0.08|<0.01
91659635|NCT00420238|183213979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.127|TWO_SIDED|95.0|-12.03|1.53|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.||1.53|-12.03|0.127
91659636|NCT00420238|183213980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.914|TWO_SIDED|95.0|-8.23|7.38|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.38|-8.23|0.914
91713370|NCT00593450|183318222|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.5||0.16|TWO_SIDED|99.2|-4.7|1.3||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.3|-4.7|0.16
91722440|NCT02239328|183337515|OTHER|Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p \< 0.05.|||||<|0.05|||||||ANOVA|||||||<0.05
91722441|NCT03331562|183337527|SUPERIORITY||Risk Ratio (RR)|0.0||||0.31|ONE_SIDED|95.0|0.0||||Fisher Exact||Lower bound cannot be estimated because there were 0 events in the comparison group.||||0|.31
91524746|NCT05652036|182924875|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as minimally improved after treatment||||||0.14|||||||Chi-squared|||||||0.14
91524747|NCT05652036|182924875|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as no difference after treatment||||||1|||||||Chi-squared|||||||1.0
91659637|NCT00420238|183213980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.544||95.0|-10.21|5.41|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.41|-10.21|0.544
91713371|NCT00593450|183318222|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.9||0.16|TWO_SIDED|99.2|-5.7|1.6||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.6|-5.7|0.16
91713372|NCT00593450|183318222|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-4.5|2.1||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.1|-4.5|0.16
91713373|NCT00593450|183318222|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-5.9|0.8||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||0.8|-5.9|0.16
91713374|NCT03877224|183318257|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.16||||0.07905|TWO_SIDED|95.0|0.36|6.01||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||6.01|0.36|0.07905
91524748|NCT05652036|182924876|OTHER|Rates of urinary retention observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
91713375|NCT03877224|183318258|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.12||||0.23215|TWO_SIDED|95.0|-0.09|5.37||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.00005 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||5.37|-0.09|0.23215
91524749|NCT05652036|182924876|OTHER|Rates of urinary tract infection observed in participants after BTX-A treatment.||||||0.24|||||||Chi-squared|||||||0.24
91524750|NCT05652036|182924876|OTHER|Rates of bleeding requiring evaluation observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
91620627|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-18.4|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \<38°C||-7.7|-18.4|
91620628|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|0.5|9.5|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38°C and \<38.5°C||9.5|0.5|
91620629|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|2.8|11.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38.5°C and \<39.5°C||11.2|2.8|
91620630|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-0.6|2.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=39.5°C||2.2|-0.6|
91620631|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-18.6|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \<38°C||-7.7|-18.6|
91620632|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|1.9|10.8|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38°C and \<38.5°C||10.8|1.9|
91620633|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||||TWO_SIDED|95.0|2.4|10.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38.5°C and \<39.5°C||10.7|2.4|
91620634|NCT01337167|183134600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-0.3|2.4|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=39.5°C||2.4|-0.3|
91620635|NCT02126670|183134615|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Chi-squared|||||||0.799
91620636|NCT04172701|183134617|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
91620637|NCT04172701|183134618|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
91620638|NCT04172701|183134619|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91620639|NCT04172701|183134620|OTHER||Hazard Ratio (HR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.308|1.663|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model.The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.663|1.308|<0.0001
91620640|NCT04172701|183134621|OTHER|||||||0.0003|||||||Individual log-linked Poisson model|||||||0.0003
91620641|NCT04172701|183134622|OTHER|||||||0.001|||||||Individual t-test or Wilcoxon test|||||||0.001
91620642|NCT04172701|183134623|OTHER||Hazard Ratio (HR)|1.145||||0.0006|TWO_SIDED|95.0|1.059|1.237|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.237|1.059|0.0006
91620643|NCT04172701|183134624|OTHER|||||||0.00074|||||||Log Rank|||||||0.00074
91620644|NCT04172701|183134625|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
91620645|NCT04172701|183134626|OTHER||Hazard Ratio (HR)|1.601|||<|0.0001|TWO_SIDED|95.0|1.404|1.826|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.826|1.404|<0.0001
91620646|NCT04172701|183134627|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91620647|NCT04172701|183134628|OTHER|||||||0.2875|||||||Wilcoxon (Mann-Whitney)|||||||0.2875
91620648|NCT04172701|183134629|OTHER|||||||0.4602|||||||Individual t-test or Wilcoxon test|||||||0.4602
91620649|NCT04172701|183134630|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
91620650|NCT04172701|183134631|OTHER|||||||0.0002|||||||Individual t-test or Wilcoxon test|||||||0.0002
91620651|NCT04172701|183134632|OTHER|||||||0.4907|||||||Individual t-test or Wilcoxon test|||||||0.4907
91620652|NCT04172701|183134633|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
91620653|NCT04172701|183134634|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91620654|NCT04172701|183134635|OTHER|||||||0.543|||||||Individual t-test or Wilcoxon test|||||||0.543
91620655|NCT04172701|183134636|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
91524751|NCT05652036|182924876|OTHER|Rates of hematuria observed in participants after BTX-A treatment.||||||0.46|||||||Chi-squared|||||||0.46
91524752|NCT05652036|182924876|OTHER|Rates of bladder pain observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
91524753|NCT05652036|182924876|OTHER|Rates of ER department evaluations observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
91620656|NCT04172701|183134637|OTHER|||||||0.363|||||||Individual t-test or Wilcoxon test|||||||0.363
91620657|NCT04172701|183134638|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
91620658|NCT04172701|183134639|OTHER|||||||0.0494|||||||Individual t-test or Wilcoxon test|||||||0.0494
91620659|NCT04172701|183134640|OTHER|||||||0.0091|||||||Individual t-test or Wilcoxon test|||||||0.0091
91620660|NCT04172701|183134641|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
91620661|NCT04172701|183134642|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
91659638|NCT00420238|183213980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21||||0.039||95.0|-16.02|-0.4|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.40|-16.02|0.039
91659639|NCT00420238|183213980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.004||95.0|-19.35|-3.73|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.73|-19.35|0.004
91659640|NCT00420238|183213983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.86||||0.122|TWO_SIDED|95.0|-15.57|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-15.57|0.122
91620662|NCT04172701|183134643|OTHER|||||||0.7298|||||||Individual t-test or Wilcoxon test|||||||0.7298
91620663|NCT04172701|183134644|OTHER|||||||0.0093|||||||Individual t-test or Wilcoxon test|||||||0.0093
91659641|NCT00420238|183213983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.45||||0.145||95.0|-15.16|2.26|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||2.26|-15.16|0.145
91659642|NCT00420238|183213983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.55||||0.005||95.0|-21.26|-3.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.84|-21.26|0.005
91620664|NCT04172701|183134645|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
91620665|NCT04172701|183134646|OTHER||Cost ratio|1.177|||<|0.0001|TWO_SIDED|95.0|1.104|1.255|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.255|1.104|<0.0001
91659643|NCT00420238|183213983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.95||||0.008||95.0|-20.66|-3.24|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.24|-20.66|0.008
91620666|NCT04172701|183134647|OTHER||Cost ratio|1.194||||0.0103|TWO_SIDED|95.0|1.043|1.367|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.367|1.043|0.0103
91659644|NCT00420238|183213987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94||||0.139|TWO_SIDED|95.0|-13.84|1.96|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||1.96|-13.84|0.139
91659645|NCT00420238|183213988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.857|TWO_SIDED|95.0|-8.88|10.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||10.67|-8.88|0.857
91659646|NCT00420238|183213988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.304||95.0|-14.88|4.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.67|-14.88|0.304
91659647|NCT00420238|183213988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.047||95.0|-19.68|-0.13|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.13|-19.68|0.047
91659648|NCT00420238|183213988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.65||||0.007||95.0|-23.43|-3.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.88|-23.43|0.007
91659649|NCT00420238|183213991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.003|TWO_SIDED|95.0|0.06|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.06|0.003
91659650|NCT00420238|183213991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.006|TWO_SIDED|95.0|0.05|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.05|0.006
91659651|NCT00420238|183213991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.205|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.17|-0.04|0.205
91659652|NCT00420238|183213992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.03|TWO_SIDED|95.0|-4.93|-0.26|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.26|-4.93|0.030
91659653|NCT00420238|183213993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.035|TWO_SIDED|95.0|-0.45|-0.02|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.||-0.02|-0.45|0.035
91659654|NCT00420238|183213994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.515|TWO_SIDED|95.0|-0.38|0.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.19|-0.38|0.515
91659655|NCT00420238|183213994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.316||95.0|-0.43|0.14|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.14|-0.43|0.316
91659656|NCT00420238|183213994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.008||95.0|-0.67|-0.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.10|-0.67|0.008
91659657|NCT00420238|183213994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.011||95.0|-0.65|-0.08|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.08|-0.65|0.011
91659658|NCT00420238|183214006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.613|TWO_SIDED|95.0|-0.22|0.37|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.37|-0.22|0.613
91659659|NCT00420238|183214007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.744|TWO_SIDED|95.0|-0.34|0.47|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.47|-0.34|0.744
91659660|NCT00420238|183214007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.625||95.0|-0.5|0.3|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.30|-0.50|0.625
91659661|NCT00420238|183214007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.325||95.0|-0.2|0.6|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.60|-0.20|0.325
91659662|NCT00420238|183214007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.76||95.0|-0.34|0.46|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.46|-0.34|0.760
91659663|NCT00420238|183214009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72||||0.49|TWO_SIDED|95.0|-18.35|8.91|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||8.91|-18.35|0.490
91659664|NCT00420238|183214009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.651||95.0|-16.73|10.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||10.54|-16.73|0.651
91659665|NCT00420238|183214009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.84||95.0|-15.12|12.34|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||12.34|-15.12|0.840
91659666|NCT00420238|183214009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.562||95.0|-17.81|9.77|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||9.77|-17.81|0.562
91659667|NCT00420238|183214011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|||<|0.0001|TWO_SIDED|95.0|-19.44|-10.03|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.||-10.03|-19.44|<0.0001
91659668|NCT00420238|183214012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||<|0.0001|TWO_SIDED|95.0|-18.17|-6.58|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and atients as a random factor.||-6.58|-18.17|<0.0001
91659669|NCT00420238|183214012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.45|||<|0.0001||95.0|-23.25|-11.65|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.65|-23.25|<0.0001
91659670|NCT00420238|183214012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.0001||95.0|-22.75|-11.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.15|-22.75|<0.0001
91659671|NCT00420238|183214012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.0001||95.0|-23.96|-12.36|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-12.36|-23.96|<0.0001
91659672|NCT00420238|183214014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||<|0.0001|TWO_SIDED|95.0|-18.23|-8.25|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.||-8.25|-18.23|<0.0001
91659673|NCT00420238|183214015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.32|||<|0.0001|TWO_SIDED|95.0|-20.55|-8.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.10|-20.55|<0.0001
91713376|NCT03877224|183318259|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|1.6||||0.66801|TWO_SIDED|95.0|-5.9|9.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00005: H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||9.0|-5.9|0.66801
91713377|NCT03877224|183318260|SUPERIORITY|Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Hodges-Lehmann median diff. vs placebo|0.19||||0.12523|TWO_SIDED|95.0|-0.06|0.48|||Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||0.48|-0.06|0.12523
91713378|NCT00461097|183318261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.5||||0.025|TWO_SIDED|95.0|4.3|43.9||No adjustments were made to the p-value.|Barnard's statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of egg white solid was compared using Barnard's statistic with the null hypothesis that there was no difference between treatment groups.||43.9|4.3|0.025
91713379|NCT01466361|183318269|SUPERIORITY_OR_OTHER||Least square mean difference|-7.23||||0.0643|TWO_SIDED|95.0|-14.89|0.44|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.||0.44|-14.89|0.0643
91713380|NCT01466361|183318269|SUPERIORITY_OR_OTHER||Least square mean difference|-7.16||||0.1489|TWO_SIDED|95.0|-16.93|2.61|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.||2.61|-16.93|0.1489
91713381|NCT01466361|183318269|SUPERIORITY_OR_OTHER||Least square mean difference|-6.33||||0.2225|TWO_SIDED|95.0|-16.56|3.9|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.||3.90|-16.56|0.2225
91713382|NCT01466361|183318269|SUPERIORITY_OR_OTHER||Least square mean difference|-5.11||||0.3491|TWO_SIDED|95.0|-15.87|5.66|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.||5.66|-15.87|0.3491
91713383|NCT01466361|183318269|SUPERIORITY_OR_OTHER||Least square mean difference|-5.0||||0.3936|TWO_SIDED|95.0|-16.6|6.59|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.||6.59|-16.60|0.3936
91713384|NCT01466361|183318270|SUPERIORITY_OR_OTHER||Least square mean difference|-3.58||||0.3922|TWO_SIDED|95.0|-11.85|4.7|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.||4.70|-11.85|0.3922
91524754|NCT05454410|182924877|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|90.0|-9.6|-0.7|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||-0.7|-9.6|
91659674|NCT00420238|183214015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.98|||<|0.0001||95.0|-21.2|-8.76|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.76|-21.20|<0.0001
91620667|NCT04172701|183134648|OTHER||Cost ratio|1.104||||0.003|TWO_SIDED|95.0|1.034|1.178|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.178|1.034|0.0030
91620668|NCT04172701|183134649|OTHER||Cost ratio|1.175|||<|0.0001|TWO_SIDED|95.0|1.13|1.221|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.221|1.130|<0.0001
91659675|NCT00420238|183214015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.19|||<|0.0001||95.0|-21.41|-8.96|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.96|-21.41|<0.0001
91620669|NCT04172701|183134650|OTHER||Cost ratio|1.236|||<|0.0001|TWO_SIDED|95.0|1.134|1.346|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.346|1.134|<0.0001
91620670|NCT04172701|183134651|OTHER||Cost ratio|1.214||||0.0212|TWO_SIDED|95.0|1.029|1.431|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.431|1.029|0.0212
91659676|NCT00420238|183214015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.41|||<|0.0001||95.0|-20.63|-8.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.19|-20.63|<0.0001
91659677|NCT00420238|183214018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.184|TWO_SIDED|95.0|0.74|4.7|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||4.70|0.74|0.184
91659678|NCT00420238|183214018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62||||0.036||95.0|1.06|6.46|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.46|1.06|0.036
91659679|NCT00420238|183214018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96||||0.001||95.0|1.89|13.03|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||13.03|1.89|0.001
91659680|NCT00420238|183214018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.065||95.0|0.95|5.96|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||5.96|0.95|0.065
91659681|NCT00420238|183214020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.004|TWO_SIDED|95.0|1.64|12.74|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||12.74|1.64|0.004
91659682|NCT00420238|183214020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.054||95.0|0.99|6.12|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.12|0.99|0.054
91659683|NCT00420238|183214020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.001||95.0|2.27|17.31|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||17.31|2.27|<0.001
91659684|NCT00420238|183214020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.025||95.0|1.14|7.27|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||7.27|1.14|0.025
91659685|NCT00486863|183214114|SUPERIORITY_OR_OTHER|||||||0.988||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.988
91659686|NCT00486863|183214115|SUPERIORITY_OR_OTHER||||||>|0.999||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||>0.999
91659687|NCT00486863|183214116|SUPERIORITY_OR_OTHER|||||||0.926||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.926
91659688|NCT00486863|183214117|SUPERIORITY_OR_OTHER|||||||0.502||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.502
91659689|NCT00486863|183214118|SUPERIORITY_OR_OTHER|||||||0.439||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.439
91659690|NCT00486863|183214119|SUPERIORITY_OR_OTHER|||||||0.704||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.704
91659691|NCT00486863|183214120|SUPERIORITY_OR_OTHER|||||||0.517||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.517
91659692|NCT00486863|183214121|SUPERIORITY_OR_OTHER|||||||0.524||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the cord blood.||||0.524
91659693|NCT00486863|183214121|SUPERIORITY_OR_OTHER|||||||0.07||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the heel stick.||||0.070
91659694|NCT00486863|183214122|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||<0.001
91659695|NCT00486863|183214127|SUPERIORITY_OR_OTHER|||||||0.991||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||0.991
91659696|NCT00830206|183214148|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® Software.|Geometric Test/Ref Ratio x 100|102.62||||||90.0|94.84|111.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.05|94.84|
91659697|NCT00830206|183214149|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|100.85||||||90.0|94.48|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|94.48|
91659698|NCT00830206|183214150|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokimetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|101.92||||||90.0|95.18|109.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.14|95.18|
91659699|NCT00905346|183214151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|98.39||||||90.0|94.36|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.59|94.36|
91659700|NCT00905346|183214152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.92||||||90.0|99.88|106.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.05|99.88|
91659701|NCT00905346|183214153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.63||||||90.0|99.24|106.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.14|99.24|
91659702|NCT03585790|183214154|NON_INFERIORITY|Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)||||||0.18|||||||t-test, 1 sided|||Ho: Single Vision - Multifocal \>= M vs. Ho: Single Vision - Multifocal \< M. Alpha = 0.05, two sided beta = 0.80||||0.18
91659703|NCT00829673|183214175|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.82||||||90.0|100.24|115.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115.98|100.24|
91659704|NCT00829673|183214176|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.74||||||90.0|97.3|104.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.29|97.3|
91659705|NCT00829673|183214177|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.5||||||90.0|97.09|104.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.03|97.09|
91659706|NCT00272779|183214178|SUPERIORITY_OR_OTHER||Difference Estimate|1.7|||||TWO_SIDED|95.0|-3.8|7.1||Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||7.1|-3.8|
91524755|NCT05454410|182924877|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|90.0|-7.0|2.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||2.1|-7.0|
91524756|NCT05454410|182924877|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|90.0|-4.0|5.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||5.1|-4.0|
91620671|NCT04172701|183134652|OTHER||Cost ratio|1.026||||0.5024|TWO_SIDED|95.0|0.952|1.105|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.105|0.952|0.5024
91620672|NCT04172701|183134653|OTHER||Cost ratio|1.304|||<|0.0001|TWO_SIDED|95.0|1.243|1.369|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.369|1.243|<0.0001
91659707|NCT00272779|183214179|SUPERIORITY_OR_OTHER||Difference Estimate|3.3|||||TWO_SIDED|95.0|-1.5|8.1|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||8.1|-1.5|
91659708|NCT00272779|183214182|SUPERIORITY_OR_OTHER||Difference Estimate|-16.4|||||TWO_SIDED|95.0|-35.9|3.1|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||3.1|-35.9|
91659709|NCT00272779|183214204|SUPERIORITY_OR_OTHER||Difference Estimate|6.1|||||TWO_SIDED|95.0|0.3|12.0||Assuming 70% response rate (70% of participants remain on treatment for 96 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||12.0|0.3|
91713385|NCT01466361|183318270|SUPERIORITY_OR_OTHER||Least square mean difference|-9.7||||0.0547|TWO_SIDED|95.0|-19.59|0.2|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.||0.20|-19.59|0.0547
91527715|NCT01976364|182930499|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
91620673|NCT04172701|183134654|OTHER|||||||0.7198|||||||Individual log-linked Poisson model|||||||0.7198
91620674|NCT04172701|183134655|OTHER||Hazard Ratio (HR)|1.072||||0.7341|TWO_SIDED|95.0|0.719|1.598|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.598|0.719|0.7341
91620675|NCT04172701|183134656|OTHER|||||||0.74|||||||Log Rank|||||||0.74
91620676|NCT04172701|183134657|OTHER|||||||0.9985|||||||Individual log-linked Poisson model|||||||0.9985
91659710|NCT00272779|183214205|SUPERIORITY_OR_OTHER||Difference Estimate|5.1|||||TWO_SIDED|95.0|-0.4|10.6|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||10.6|-0.4|
91659711|NCT00272779|183214207|SUPERIORITY_OR_OTHER||Difference Estimate|-21.2|||||TWO_SIDED|95.0|-43.3|0.9|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||0.9|-43.3|
91722442|NCT04044690|183337601|SUPERIORITY||Odds Ratio (OR)|1.13||||0.371008|TWO_SIDED|95.0|0.551|2.309||Threshold of significance at \<= 0.025.|Regression, Logistic|Exact logistic regression model including fixed effects for treatment, region (Japan vs. non-Japan) and Baseline MMT-8 (≤ 142 points vs. \>142 points).|Rubin's rule applied following MI.|||2.309|0.551|0.371008
91659712|NCT00272779|183214223|SUPERIORITY_OR_OTHER||point estimate|0.761|||||TWO_SIDED|90.0|0.507|1.142|||ANOVA||Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.142|0.507|
91659713|NCT00272779|183214224|SUPERIORITY_OR_OTHER||point estimate|1.46|||||TWO_SIDED|90.0|1.005|2.121|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||2.121|1.005|
91659714|NCT00272779|183214225|SUPERIORITY_OR_OTHER||point estimate|0.839|||||TWO_SIDED|90.0|0.612|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.612|
91659715|NCT00272779|183214226|SUPERIORITY_OR_OTHER||point estimate|0.282|||||TWO_SIDED|90.0|0.181|0.439|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||0.439|0.181|
91659716|NCT00272779|183214227|SUPERIORITY_OR_OTHER||point estimate|0.925|||||TWO_SIDED|90.0|0.699|1.223|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.223|0.699|
91527716|NCT01976364|182930499|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
91659717|NCT00272779|183214228|SUPERIORITY_OR_OTHER||point estimate|0.853|||||TWO_SIDED|90.0|0.626|1.161|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.161|0.626|
91659718|NCT00272779|183214229|SUPERIORITY_OR_OTHER||point estimate|0.89|||||TWO_SIDED|90.0|0.689|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.689|
91722443|NCT04044690|183337602|SUPERIORITY||LS mean difference|1.46||||0.360939|TWO_SIDED|95.0|-6.651|9.57||Descriptive p-value.|MMRM|||||9.570|-6.651|0.360939
91620677|NCT04172701|183134658|OTHER||Hazard Ratio (HR)|0.879||||0.5097|TWO_SIDED|95.0|0.6|1.289|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.289|0.600|0.5097
91620678|NCT04172701|183134659|OTHER|||||||0.51|||||||Log Rank|||||||0.51
91620679|NCT04172701|183134660|OTHER|||||||0.6069|||||||Individual log-linked Poisson model|||||||0.6069
91722444|NCT04044690|183337603|SUPERIORITY||LS mean difference|-2.4||||0.730994|TWO_SIDED|95.0|-10.15|5.33||Descriptive p-value.|MMRM|||||5.33|-10.15|0.730994
91527480|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|33.86||||0.0644|TWO_SIDED|95.0|-2.03|69.75|||random coefficient regression|||In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.||69.75|-2.03|0.0644
91620680|NCT04172701|183134661|OTHER||Hazard Ratio (HR)|1.025||||0.896|TWO_SIDED|95.0|0.705|1.49|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.490|0.705|0.8960
91620681|NCT04172701|183134662|OTHER|||||||0.9|||||||Log Rank|||||||0.9
91620682|NCT04172701|183134663|OTHER|||||||0.1354|||||||Individual log-linked Poisson model|||||||0.1354
91620683|NCT04172701|183134664|OTHER||Hazard Ratio (HR)|0.59||||0.1158|TWO_SIDED|95.0|0.305|1.139|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.139|0.305|0.1158
91620684|NCT04172701|183134665|OTHER|||||||0.11|||||||Log Rank|||||||0.11
91620685|NCT02757092|183134666|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91524757|NCT05454410|182924883|SUPERIORITY|||||||0.0242||||||P-value for the selected model best representing the underlying DR (the lowest p-value out of the 6 candidate models), adjusted for multiple comparisons.|Multiple contrast test|||MCP-Mod was used to check if there was a DR relationship between the change from baseline to 24 hours in MADRS total score and the doses received. The Least squares means under the primary estimand were used to test the null hypothesis of a flat DR relationship at a one-sided significance level of 5% against the alternative hypothesis of a non-flat DR curve. Six candidate DR curves were used to derive the optimal model contrasts for the multiple contrast tests. A monotone DR was assumed.||||0.0242
91524758|NCT00895622|182924896|OTHER||Kappa statistic|0.79|||<|0.0001|TWO_SIDED|95.0|0.71|0.87|||Z test|||"The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):~\< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.~The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement."||0.87|0.71|<0.0001
91524759|NCT01320943|182924899|SUPERIORITY|||||||0.022||||||Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.|Log Rank|||||||0.022
91524760|NCT02404389|182924923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.515|TWO_SIDED|90.0|-0.12|0.12|||Posterior mean|||||0.12|-0.12|0.515
91524761|NCT02404389|182924923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.517|TWO_SIDED|90.0|-0.12|0.13|||posterior mean|||||0.13|-0.12|0.517
91524762|NCT00658138|182924948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|Mean Difference (Final Values)|0.05||||0.05|||||||Wilcoxon (Mann-Whitney)|||Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.||||0.05
91524763|NCT00658138|182924948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|percentage of Alpha values||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is adhesives are not different in clinical performance at one year||||>0.05
91524764|NCT03857230|182924963|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline AUC0-192 were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|93.31||||0.05|TWO_SIDED|90.0|87.25|99.79|||ANOVA|||Statistical comparison of the obtained results comprised the calculation of parametric bilateral 90 % CIs for the ratios of the corresponding mean values of the pharmacokinetic parameters of the study and comparator drug. The equivalence of the pharmacokinetics of the drug products will be proven if the limits of the evaluated CIs for the ratios of the mean values are in the range of 80.00-125.00%.||99.79|87.25|0.05
91524765|NCT03857230|182924964|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline Cmax were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|87.93||||0.05|TWO_SIDED|90.0|82.85|93.33|||ANOVA|||||93.33|82.85|0.05
91524766|NCT00552786|182924968|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two-sided|ANOVA|Assessing the bioequivalence on temporary threshold shift at3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
91524767|NCT00552786|182924969|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Assessing the bioequivalence on temporary threshold shift at 3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
91524768|NCT03549234|182924977|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB (paravertebral block) using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||We hypothesized that 1) analgesia would be noninferior in the recovery room as measured on a Numeric Rating Scale with ESPB (erector spinae plane block), and 2) opioid consumption would be noninferior in the operating and recovery rooms with ESPB. We simulated pain scores from a discrete distribution with median (interquartile range) 2 (0-3). The sample size of 50 per group provided 81% power to detect noninferiority in pain.||||0.0011
91620686|NCT02757092|183134667|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91722445|NCT04044690|183337604|SUPERIORITY||LS mean difference|-5.3||||0.001647|TWO_SIDED|95.0|-8.72|-1.82||Descriptive p-value.|MMRM|||||-1.82|-8.72|0.001647
91620687|NCT02757092|183134668|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91524769|NCT03549234|182924978|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||||||0.0043
91524770|NCT01590771|182924991|SUPERIORITY_OR_OTHER||Robust regression|-0.61|||<|0.001|TWO_SIDED|95.0|-0.77|-0.44||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.|ANCOVA||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.|||-0.44|-0.77|<0.001
91524771|NCT01590771|182924992|SUPERIORITY_OR_OTHER||Difference in least squares mean|-32.9|||<|0.001|TWO_SIDED|95.0|-45.4|-20.4||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.|ANCOVA|||||-20.4|-45.4|<0.001
91524772|NCT01590771|182924993|SUPERIORITY_OR_OTHER||Estimate difference|-16.8|||<|0.001|TWO_SIDED|95.0|-23.3|-10.2||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.|Robust regression|||||-10.2|-23.3|<0.001
91524773|NCT01590771|182924994|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.2||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.20|-0.63|<0.001
91524774|NCT01590771|182924995|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.53|-1.07|<0.001
91524775|NCT01590771|182924996|SUPERIORITY_OR_OTHER||Estimate difference|-27.2|||<|0.001|TWO_SIDED|95.0|-41.2|-13.2||Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.|Robust regression|||||-13.2|-41.2|<0.001
91524776|NCT01590771|182924997|SUPERIORITY_OR_OTHER||Difference in least squares mean|-37.7|||<|0.001|TWO_SIDED|95.0|-56.9|-18.4||The ANCOVA model controlled for treatment and baseline 2-hr PMG value.|ANCOVA|||||-18.4|-56.9|<0.001
91524777|NCT01590771|182924998|SUPERIORITY_OR_OTHER||Estimate Difference|-16.5|||<|0.001|TWO_SIDED|95.0|-25.3|-7.8||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.8|-25.3|<0.001
91524778|NCT01590771|182924999|SUPERIORITY_OR_OTHER||Estimate Difference|-17.0|||<|0.001|TWO_SIDED|95.0|-26.9|-7.1||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.1|-26.9|<0.001
91524779|NCT01015807|182925019|OTHER|||||||0.48|||||||ANOVA|||We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed \[alpha\] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)||||0.48
91524780|NCT01486758|182925075|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
91524781|NCT01486758|182925079|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|||||||0.048
91524782|NCT03926065|182925083|SUPERIORITY|||||||0.126|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1260
91524783|NCT03926065|182925083|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
91524784|NCT03926065|182925083|SUPERIORITY|||||||0.0992|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.0992
91524785|NCT03926065|182925084|SUPERIORITY|||||||0.5502|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.5502
91524786|NCT03926065|182925084|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0072
91620688|NCT02757092|183134669|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620689|NCT02757092|183134670|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620690|NCT02757092|183134671|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91620691|NCT02757092|183134672|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91620692|NCT02757092|183134673|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620693|NCT02757092|183134674|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620694|NCT02757092|183134675|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620695|NCT02757092|183134676|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620696|NCT02757092|183134677|SUPERIORITY|||||||0.05|||||||Chi-squared|||Descriptive statistics were expressed as mean ± standard deviation or median and interquartile range depending on the nature and distribution of the variables||||0.05
91620697|NCT02757092|183134678|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91620698|NCT02757092|183134679|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620699|NCT02757092|183134680|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620700|NCT02757092|183134681|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91524787|NCT03926065|182925085|SUPERIORITY|||||||0.103|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1030
91620701|NCT02757092|183134683|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91659719|NCT00272779|183214253|SUPERIORITY_OR_OTHER|||||||0.0847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0847
91691903|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6065||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6065
91620702|NCT02757092|183134684|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620703|NCT02757092|183134685|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620704|NCT02757092|183134686|SUPERIORITY||||||<|0.05|||||||Chi-squared|||null hypothesis||||<0.05
91620705|NCT02757092|183134687|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91620706|NCT02757092|183134688|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91620707|NCT02757092|183134689|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620708|NCT02757092|183134690|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
91524788|NCT03926065|182925085|SUPERIORITY|||||||0.0178|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0178
91524789|NCT03926065|182925085|SUPERIORITY|||||||0.241|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.2410
91524790|NCT03926065|182925086|SUPERIORITY|||||||0.0012|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.0012
91524791|NCT03926065|182925086|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
91524792|NCT02687412|182925115|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
91524793|NCT02687412|182925116|SUPERIORITY||Mean Difference (Final Values)|-4041.0|STANDARD_ERROR_OF_MEAN|1831.042||0.029|TWO_SIDED|95.0|-7672.301|-411.065|||t-test, 2 sided|||||-411.065|-7672.301|0.029
91524794|NCT02687412|182925117|SUPERIORITY||Mean Difference (Final Values)|20.3739|STANDARD_ERROR_OF_MEAN|6.4198||0.002|TWO_SIDED|95.0|7.6414|33.1065|||t-test, 2 sided|||||33.1065|7.6414|0.002
91524795|NCT02687412|182925118|SUPERIORITY|||||||0.014|||||||Chi-squared|||||||0.014
91524796|NCT02687412|182925119|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
91524797|NCT02687412|182925120|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91524798|NCT02687412|182925121|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91524799|NCT02687412|182925122|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91524800|NCT02687412|182925123|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91524801|NCT02687412|182925124|SUPERIORITY||Mean Difference (Final Values)|-0.10046|STANDARD_ERROR_OF_MEAN|0.1915||0.601|TWO_SIDED|95.0|-0.4819|0.2817|||t-test, 2 sided|||||0.2817|-0.4819|0.601
91524802|NCT02687412|182925125|SUPERIORITY||Mean Difference (Final Values)|164.746|STANDARD_ERROR_OF_MEAN|317.79||0.605|TWO_SIDED|95.0|-465.0|794.0|||t-test, 2 sided|||||794|-465|0.605
91524803|NCT03239873|182925135|NON_INFERIORITY|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-2.7|2.8|||Miettinen and Nurminen|||||2.8|-2.7|<0.001
91524804|NCT03239873|182925135|OTHER|Acceptability|Antibody Response Rate|98.4|||<|0.001|TWO_SIDED|95.0|95.9|99.6|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||99.6|95.9|<0.001
91524805|NCT03239873|182925136|NON_INFERIORITY|The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio \[VARIVAX® PE34 process/VARIVAX® 2016 commercial product\] being \>0.67.|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||Miettinen and Nurminen|||||1.1|0.9|<0.001
91524806|NCT03239873|182925137|OTHER||Difference in Percentage|2.0||||0.436|TWO_SIDED|95.0|-3.1|7.1|||Miettinen & Nurminen|||Up to 42 days after Vaccination 1||7.1|-3.1|0.436
91524807|NCT03239873|182925137|OTHER||Difference in Percentage|2.9||||0.204|TWO_SIDED|95.0|-1.6|7.5|||Miettinen & Nurminen|||Up to 42 days after Vaccination 2||7.5|-1.6|0.204
91524808|NCT03239873|182925138|OTHER||Difference in Percentage|-1.3||||0.102|TWO_SIDED|95.0|-3.5|0.4|||Miettinen & Nurminen|||Measles-like rash||0.4|-3.5|0.102
91524809|NCT03239873|182925138|OTHER||Difference in Percentage|0.3||||0.317|TWO_SIDED|95.0|-0.9|1.9|||Miettinen & Nurminen|||Rubella-like rash||1.9|-0.9|0.317
91524810|NCT03239873|182925138|OTHER||Difference in Percentage|1.3||||0.241||95.0|-1.0|4.0|||Miettinen & Nurminen|||Varicella-like rash||4.0|-1.0|0.241
91524811|NCT03239873|182925138|OTHER||Difference in Percentage|-0.3||||0.318|TWO_SIDED|95.0|-1.9|0.9|||Miettinen & Nurminen|||Zoster-like rash||0.9|-1.9|0.318
91620709|NCT02757092|183134692|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620710|NCT02757092|183134693|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620711|NCT02757092|183134694|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91620712|NCT01975246|183134698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.3|-2.4|||ANCOVA|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-2.4|-5.3|<0.0001
91620713|NCT01975246|183134699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-7.6|-3.1|||ANCOVA|Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-3.1|-7.6|<0.0001
91620714|NCT01975246|183134700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.0051|TWO_SIDED|95.0|1.2|3.4|||Regression, Logistic|Logistic regression model includes treatment and center as fixed effects.||"The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as failure up to the planned final visit to be reached by all patients."||3.4|1.2|<0.0051
91620715|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|0.99|
91620716|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||0.89|0.59|
91713386|NCT03101150|183318293|OTHER|A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.|Risk Ratio (RR)|0.163|||<|0.05|TWO_SIDED|95.0|0.02|1.32|||Chi-squared|||Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.||1.32|0.02|<0.05
91713387|NCT03101150|183318294|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91713388|NCT03101150|183318295|OTHER||Risk Ratio (RR)|0.43|||<|0.02|TWO_SIDED|95.0|0.19|0.94|||Chi-squared|||||0.94|0.19|<0.02
91524812|NCT03239873|182925139|OTHER||Difference in Percentage|1.1||||0.17|TWO_SIDED|95.0|-0.7|3.4|||Miettinen & Nurminen|||Measles-like rash||3.4|-0.7|0.170
91659720|NCT00272779|183214254|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0058
91659721|NCT00272779|183214255|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_2265 reported in Outcome Measure 16.||||0.0058
91659722|NCT00272779|183214256|SUPERIORITY_OR_OTHER|||||||0.0253||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_598 reported in Outcome Measure 16.||||0.0253
91524813|NCT03239873|182925139|OTHER||Difference in Percentage|-0.3||||0.576|TWO_SIDED|95.0|-2.2|1.4|||Miettinen & Nurminen|||Varicella-like rash||1.4|-2.2|0.576
91524814|NCT03239873|182925139|OTHER||Difference in Percentage|0.4||||0.312|TWO_SIDED|95.0|-1.0|2.0|||Miettinen & Nurminen|||Zoster-like rash||2.0|-1.0|0.312
91524815|NCT03239873|182925140|OTHER||Difference of Percentage|-1.0||||0.696|TWO_SIDED|95.0|-5.9|4.0|||Miettinen & Nurminen|||Injection site erythema||4.0|-5.9|0.696
91524816|NCT03239873|182925140|OTHER||Difference in Percentage|0.7||||0.796|TWO_SIDED|95.0|-4.7|6.2|||Miettinen & Nurminen|||Injection site pain||6.2|-4.7|0.796
91524817|NCT03239873|182925140|OTHER||Difference in Percentage|-2.7||||0.111||95.0|-6.2|0.7|||Miettinen & Nurminen|||Injection site swelling||0.7|-6.2|0.111
91524818|NCT03239873|182925141|OTHER||Difference in Percentage|-0.3||||0.931|TWO_SIDED|95.0|-6.9|6.4|||Miettinen & Nurminen|||Injection site erythema||6.4|-6.9|0.931
91524819|NCT03239873|182925141|OTHER||Difference in Percentage|-1.6||||0.523|TWO_SIDED|95.0|-6.6|3.4|||Miettinen & Nurminen|||Injection site pain||3.4|-6.6|0.523
91524820|NCT03239873|182925141|OTHER||Difference in Percentage|2.0||||0.415|TWO_SIDED|95.0|-2.9|6.9|||Miettinen & Nurminen|||Injection site swelling||6.9|-2.9|0.415
91524821|NCT03239873|182925142|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.4|6.7|||||Miettinen \& Nurminen|||6.7|-3.4|
91524822|NCT03239873|182925143|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Miettinen \& Nurminen|||2.6|-2.5|
91524823|NCT03239873|182925144|OTHER||Difference in Percentage|1.9|||||TWO_SIDED|95.0|-6.1|9.8|||||Miettinen \& Nurminen|||9.8|-6.1|
91524824|NCT03239873|182925145|OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-4.7|9.2|||||Miettinen \& Nurminen|||9.2|-4.7|
91524825|NCT03239873|182925150|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
91524826|NCT03239873|182925151|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
91620717|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.44|1.96|
91620718|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.86|2.22|
91620719|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|1.10|
91620720|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.74|1.12|
91620721|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.24|1.59|
91620722|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.23|0.77|
91620723|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.86|1.61|
91659723|NCT00272779|183214257|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE\_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_C130R reported in Outcome Measure 16.||||0.1173
91620724|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.92|1.81|
91659724|NCT00272779|183214258|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_734 reported in Outcome Measure 16.||||0.1173
91524827|NCT03239873|182925154|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-4.6|10.3|||||Miettinen and Nurminen|||10.3|-4.6|
91524828|NCT01703702|182925158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.22|2.38|||Chi-squared|||||2.38|1.22|0.002
91524829|NCT01703702|182925159|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.568|TWO_SIDED|95.0|-1.54|0.84|||ANCOVA|Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.||||0.84|-1.54|0.568
91524830|NCT01703702|182925160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.9|||<|0.001|TWO_SIDED|95.0|20.0|96.12|||Chi-squared|||||96.12|20|<0.001
91524831|NCT01703702|182925161|SUPERIORITY_OR_OTHER||LS Mean Difference|20.69|||<|0.001|TWO_SIDED|95.0|18.95|22.43|||ANCOVA|Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)||Comparison of change in diagnostic confidence at follow-up (3 months)||22.43|18.95|<0.001
91620725|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.79|1.42|
91524832|NCT01703702|182925162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.144|TWO_SIDED|95.0|0.92|1.78|||Chi-squared|||||1.78|0.92|0.144
91620726|NCT01646398|183134701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.49|1.84|
91620727|NCT01646398|183134702|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||||TWO_SIDED|95.0|19.3|34.0||||||Difference in proportions (13vPnC - 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.||34.0|19.3|
91620728|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|0.99|
91620729|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||0.89|0.59|
91620730|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.44|1.96|
91620731|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.86|2.22|
91620732|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|1.10|
91620733|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.74|1.12|
91620734|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.24|1.59|
91524833|NCT01703702|182925163|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.925|TWO_SIDED|95.0|-3.2|3.53|||ANCOVA|Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).||||3.53|-3.20|0.925
91620735|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.23|0.77|
91620736|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.86|1.61|
91620737|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.92|1.81|
91620738|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.79|1.42|
91620739|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.49|1.84|
91620740|NCT01646398|183134703|SUPERIORITY_OR_OTHER||GMT Ratio|3.1|||||TWO_SIDED|95.0|2.38|4.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.||4.14|2.38|
91620741|NCT00880763|183134768|SUPERIORITY_OR_OTHER||Adjusted difference in percent|65.1|||<|0.001|TWO_SIDED|95.0|37.0|82.8|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||82.8|37.0|<0.001
91524834|NCT01703702|182925164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.7|1.54|||Chi-squared|||Major Diagnostic Tests||1.54|0.70|0.857
91620742|NCT00880763|183134768|SUPERIORITY_OR_OTHER||Adjusted difference in percent|74.5|||<|0.001|TWO_SIDED|95.0|47.6|89.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||89.0|47.6|<0.001
91659725|NCT00272779|183214259|SUPERIORITY_OR_OTHER|||||||0.1847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE\_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_R176C reported in Outcome Measure 16.||||0.1847
91659726|NCT00272779|183214260|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6\_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6\_5309 reported in Outcome Measure 16||||0.1833
91659727|NCT00272779|183214261|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.1833
91620743|NCT00880763|183134768|SUPERIORITY_OR_OTHER||Adjusted difference in percent|55.4|||<|0.001|TWO_SIDED|95.0|24.9|76.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||76.0|24.9|<0.001
91620744|NCT00880763|183134769|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-11.3|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-11.3|
91620745|NCT00880763|183134769|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.9|||||TWO_SIDED|95.0|-12.4|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.4|
91620746|NCT00880763|183134769|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-12.0|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.0|
91620747|NCT00880763|183134770|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.5|||||TWO_SIDED|95.0|-2.5|36.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.2|-2.5|
91713389|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5221||||||The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5221
91524835|NCT01703702|182925164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.36|2.81|||Chi-squared|||Alzheimer's/Cognitive Medication||2.81|1.36|<0.001
91524836|NCT01703702|182925164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.063|TWO_SIDED|95.0|0.97|2.64|||Chi-squared|||Neuropsychological Tests||2.64|0.97|0.063
91524837|NCT01703702|182925164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.741|TWO_SIDED|95.0|0.69|1.7|||Chi-squared|||Physician Follow-up for Re-evaluation||1.70|0.69|0.741
91620748|NCT00880763|183134770|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.6|||||TWO_SIDED|95.0|-3.4|36.3|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.3|-3.4|
91620749|NCT00880763|183134770|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.4|||||TWO_SIDED|95.0|-3.3|36.1|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.1|-3.3|
91620750|NCT00880763|183134771|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|||||TWO_SIDED|95.0|-2.3|-1.2|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.2|-2.3|
91620751|NCT00880763|183134771|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.9|||||TWO_SIDED|95.0|-2.4|-1.3|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.3|-2.4|
91659728|NCT00272779|183214262|SUPERIORITY_OR_OTHER|||||||0.1694||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122\_5980 reported in Outcome Measure 16.||||0.1694
91713390|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.25||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.|Wilcoxon test|||||||0.25
91620752|NCT00880763|183134771|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.6|||||TWO_SIDED|95.0|-2.2|-1.1|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.1|-2.2|
91620753|NCT01746940|183134796|SUPERIORITY_OR_OTHER|||||||0.1088||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.1088
91620754|NCT01746940|183134796|SUPERIORITY_OR_OTHER|||||||0.0005||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.0005
91713391|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.|Wilcoxon test|||||||0.50
91524838|NCT01703702|182925164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.046|TWO_SIDED|95.0|1.01|2.08|||Chi-squared|||Specialist Referral||2.08|1.01|0.046
91527717|NCT01976364|182930500|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
91659729|NCT00272779|183214263|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL\_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL\_1842 reported in Outcome Measure 16.||||0.1335
91659730|NCT00272779|183214264|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN\_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_730 reported in Outcome Measure 16.||||0.1335
91659731|NCT00272779|183214265|SUPERIORITY_OR_OTHER|||||||0.1696||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122\_5980 reported in Outcome Measure 16.||||0.1696
91659732|NCT00376623|183214288|OTHER|A one-sided exact binomial test with a 2.5 % significance level was used to detect the difference between BI 2536 and historical placebo with objective response rate = 0.9 % (two out of 211) with a 95 % confidence interval of 0.2 % to 3 %.||||||0.0548|||||||One-sided exact binomial test|Null hypothesis H0: p \<= 0.009 Alternative hypothesis HA: p \> 0.009||Efficacy of BI 2536 was evaluated by comparing the tumour response rate of the present trial with the tumour response rate published for patients with the same stage of disease treated with placebo. For this, treatment groups 'BI 2536 200 mg' and 'combination of treatment group 50 mg BI 2536 (day 1 - day 3) and 60 mg BI 2536 (day 1 - day 3)' were pooled together and compared to historical placebo.||||0.0548
91713392|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.|Wilcoxon test|||||||0.16
91620755|NCT03057951|183134797|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.79||||0.0003|TWO_SIDED|95.03|0.69|0.9|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Cox regression, with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) at baseline.~alpha=0.0497 (resulting from interim analysis)."||0.90|0.69|0.0003
91620756|NCT03057951|183134798|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.73||||0.0009|TWO_SIDED|95.03|0.61|0.88|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, baseline LVEF, region, baseline diabetes status, sex, and treatment. eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction. alpha=0.0497 (resulting from interim analysis).||0.88|0.61|0.0009
91620757|NCT03057951|183134799|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.363|||<|0.0001|TWO_SIDED|99.9|0.861|1.865|||Random intercept random coeff. model||Empa 10 mg vs. Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with factors age, baseline eGFR (CKD-EPI), baseline LVEF as linear covariate(s) and region, baseline diabetes status, sex, baseline-by-time interaction, treatment-by-time interaction and treatment as fixed effects.~Only 'on-treatment' data from treated patients were used. alpha=0.001. covariance structure: Unstructured."||1.865|0.861|<0.0001
91620758|NCT03057951|183134800|OTHER||Hazard Ratio (HR)|0.95||||0.7243|TWO_SIDED|95.0|0.73|1.24|||Regression, Cox||Comparison vs Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.24|0.73|0.7243
91620759|NCT03057951|183134801|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.6|0.83|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||0.83|0.60|<0.0001
91620760|NCT03057951|183134802|OTHER||Hazard Ratio (HR)|0.91||||0.2951|TWO_SIDED|95.0|0.76|1.09|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.09|0.76|0.2951
91620761|NCT03057951|183134803|OTHER||Hazard Ratio (HR)|1.0||||0.9893|TWO_SIDED|95.0|0.87|1.15|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.15|0.87|0.9893
91620762|NCT03057951|183134804|OTHER||Hazard Ratio (HR)|0.84||||0.1539|TWO_SIDED|95.0|0.65|1.07|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.07|0.65|0.1539
91620763|NCT03057951|183134805|OTHER||Adjusted mean difference|1.32|STANDARD_ERROR_OF_MEAN|0.44||0.0028|TWO_SIDED|95.0|0.45|2.19|||Mixed Model Repeated Measures (MMRM)||Comparison vs Placebo \[T-P\]|"Model includes age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF) as linear covariate(s) and region, baseline diabetes status, sex, week reachable, treatment-by-visit interaction, baseline KCCQ-Clinical-Summary-Score-by-visit interaction as fixed effect(s).~Unstructured covariance structure."||2.19|0.45|0.0028
91620764|NCT03057951|183134806|OTHER||Hazard Ratio (HR)|0.93||||0.1012|TWO_SIDED|95.0|0.85|1.01|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for the dependence between recurrent all-cause hospitalisation and all-cause mortality was used. Joint frailty model with terms for age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF), treatment, region, baseline diabetes status and sex.||1.01|0.85|0.1012
91620765|NCT00696436|183134807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.27|||<|0.001|TWO_SIDED|95.0|-16.54|-12.01||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-12.01|-16.54|<0.001
91659733|NCT00376623|183214289|OTHER||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.67|1.55|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.55|0.67|0.92
91659734|NCT00376623|183214290|OTHER||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.78|0.7|0.65
91659735|NCT00376623|183214293|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.51|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.51|0.94|
91659736|NCT00376623|183214294|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.49|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||1.49|0.59|
91620766|NCT00696436|183134807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.001|TWO_SIDED|95.0|-15.41|-10.91||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-10.91|-15.41|<0.001
91659737|NCT00376623|183214295|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.81|2.01|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.01|0.81|
91659738|NCT02331394|183214305|EQUIVALENCE|"The equivalence assumes that the true mean difference between the paired samples is zero. Under this model, all observable differences are explained by random variation.Equality margins are:~Upper Equivalence Margin=1.5 Lower Equivalence Margin=-1.5"|||||<|0.05|||||||t-test, 2 sided|||Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant||||<0.05
91659739|NCT02331394|183214308|SUPERIORITY|Pared t-test was used to evaluate the significance of the change in scores||||||0.02|||||||t-test, 2 sided|||||||0.02
91713393|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8665||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8665
91659740|NCT01371786|183214309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|||||TWO_SIDED|95.0|-21.76|-4.09||No formal statistical testing was conducted. Only descriptive statistics were calculated and presented.|||Difference calculated as Mometasone minus Ciclesonide|No formal null hypothesis was stated or tested.Descriptive statistics only were calculated and presented. The sample size was determined outside of statistical considerations. The sample size of 10 subjects was sufficient to provide approximately 80% power to detect a difference of 25% between the two treatment groups in the percentage of nasal deposition approximately 2 minutes post dose, assuming a two-sided test evaluated at a significance level of 0.05, with a SD of the difference of 23.17%.||-4.09|-21.76|
91659741|NCT04459585|183214314|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.88|||||TWO_SIDED|90.0|77.57|161.35|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||161.35|77.57|
91527718|NCT01976364|182930500|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91659742|NCT04459585|183214314|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.98|||||TWO_SIDED|90.0|77.2|165.34|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||165.34|77.20|
91659743|NCT04459585|183214315|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.37|||||TWO_SIDED|90.0|78.51|157.97|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||157.97|78.51|
91659744|NCT04459585|183214315|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.08|||||TWO_SIDED|90.0|77.35|159.51|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.51|77.35|
91659745|NCT04459585|183214316|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.97|||||TWO_SIDED|90.0|79.38|160.79|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||160.79|79.38|
91659746|NCT04459585|183214316|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|110.72|||||TWO_SIDED|90.0|76.77|159.68|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.68|76.77|
91659747|NCT01061866|183214332|NON_INFERIORITY_OR_EQUIVALENCE|p less than or equal to 0.05, repeated measures ANOVA|Mean Difference (Final Values)|0.02|||<|0.02||||||p-value is non-adjusted for multiple comparisons|ANOVA|Was adjusted the degrees of freedom for the averaged test of significance.|The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.|Power=0.02||||<0.02
91659748|NCT02459951|183214335|SUPERIORITY|||||||0.059||||||"refer to cylinder A (.5 diameter)"|Regression, Logistic|||||||.059
91527719|NCT01976364|182930500|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
91659749|NCT02459951|183214335|SUPERIORITY||geometric mean ratio B|||||0.465|||||||Regression, Logistic|"refer to cylinder B(1 diameter)"||||||0.465
91659750|NCT02459951|183214335|SUPERIORITY||geometric mean ratio C|||||0.022||||||"refer to cylinder C (1.5 diameter)"|Regression, Logistic|||||||.022
91659751|NCT02459951|183214335|SUPERIORITY||geometric mean ratio D|||||0.004||||||"refer to cylinder D (2 diameter)"|Regression, Logistic|||||||.004
91659752|NCT02459951|183214335|SUPERIORITY||geometric mean ratio E|||||0.002||||||"refer to cylinder E (2.5 diameter)"|Regression, Logistic|||||||.002
91659753|NCT04239872|183214365|SUPERIORITY||Mean Difference (Net)|-0.00778||||0.8412|TWO_SIDED|95.0|-0.09209|0.07653||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.07653|-0.09209|0.8412
91659754|NCT04239872|183214366|SUPERIORITY||Mean Difference (Net)|-0.06907||||0.6504|TWO_SIDED|95.0|-0.3955|0.2573||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 12 pairs of data, DF=11|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.2573|-0.3955|0.6504
91659755|NCT04239872|183214367|SUPERIORITY||Mean Difference (Net)|0.5307||||0.0024|TWO_SIDED|95.0|0.2372|0.8243||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8243|0.2372|0.0024
91659756|NCT04239872|183214368|SUPERIORITY||Mean Difference (Net)|0.5643||||0.0013|TWO_SIDED|95.0|0.2938|0.8348||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 9 pairs of data, DF=8|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8348|0.2938|0.0013
91659757|NCT04239872|183214369|SUPERIORITY||Mean Difference (Net)|-0.1135||||0.2041|TWO_SIDED|95.0|-0.2964|0.06929||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06929|-0.2964|0.2041
91659758|NCT04239872|183214370|SUPERIORITY||Mean Difference (Net)|1.095|||<|0.0001|TWO_SIDED|95.0|0.7736|1.416||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.416|0.7736|<0.0001
91659759|NCT04239872|183214371|SUPERIORITY||Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.112|1.825||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.825|1.112|<0.0001
91659760|NCT04239872|183214372|SUPERIORITY||Mean Difference (Net)|1.549|||<|0.0001|TWO_SIDED|95.0|1.081|2.017||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||2.017|1.081|<0.0001
91659761|NCT04239872|183214373|SUPERIORITY||Mean Difference (Net)|-115.6||||0.5543|TWO_SIDED|95.0|-584.8|353.6||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 6 pairs of data, DF=5|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||353.6|-584.8|0.5543
91659762|NCT04239872|183214374|SUPERIORITY||Mean Difference (Net)|1.328||||0.0003|TWO_SIDED|95.0|0.842|1.814||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.814|0.8420|0.0003
91527720|NCT01976364|182930500|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
91659763|NCT04239872|183214375|SUPERIORITY||Mean Difference (Net)|-0.09023||||0.2824|TWO_SIDED|95.0|-0.2613|0.08082||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.08082|-0.2613|0.2824
91659764|NCT04239872|183214376|SUPERIORITY||Mean Difference (Net)|0.6269||||0.0002|TWO_SIDED|95.0|0.3488|0.905||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.9050|0.3488|0.0002
91659765|NCT04239872|183214377|SUPERIORITY||Mean Difference (Net)|0.8946|||<|0.0001|TWO_SIDED|95.0|0.6671|1.122||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.122|0.6671|<0.0001
91659766|NCT04239872|183214378|SUPERIORITY||Mean Difference (Net)|0.973|||<|0.0001|TWO_SIDED|95.0|0.7597|1.186||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.186|0.7597|<0.0001
91659767|NCT04239872|183214379|SUPERIORITY||Mean Difference (Net)|0.9827|||<|0.0001|TWO_SIDED|95.0|0.7758|1.19||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.19|0.7758|<0.0001
91713394|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.88
91527481|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|40.95||||0.0351|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.||79.01|2.88|0.0351
91659768|NCT04239872|183214380|SUPERIORITY||Mean Difference (Net)|0.9181|||<|0.0001|TWO_SIDED|95.0|0.6573|1.179||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.179|0.6573|<0.0001
91524839|NCT02948959|182925186|SUPERIORITY|To control the type-I error rate for the analysis of outcome measure, a hierarchical testing procedure was applied at a 2-sided 5% significant level. Testing was then performed sequentially in the order endpoints were reported. Hierarchical testing sequence continued only if the previous endpoint was statistically significant.|Risk Ratio (RR)|0.353|||<|0.0001|TWO_SIDED|95.0|0.222|0.562||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.562|0.222|<0.0001
91524840|NCT02948959|182925187|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|Risk Ratio (RR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.274|0.605||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.605|0.274|<0.0001
91524841|NCT02948959|182925188|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.32||||0.0036|TWO_SIDED|95.0|1.76|8.88||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.||8.88|1.76|0.0036
91524842|NCT02948959|182925189|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.21||||0.0009|TWO_SIDED|95.0|2.14|8.27||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by visit interaction as covariates.||8.27|2.14|0.0009
91524843|NCT02948959|182925190|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.26||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.26|-0.66|<0.0001
91524844|NCT02948959|182925191|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.33||||0.0001|TWO_SIDED|95.0|-0.5|-0.16||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.16|-0.50|0.0001
91524845|NCT02948959|182925192|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-24.6|-16.59||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-16.59|-24.60|<0.0001
91524846|NCT02948959|182925193|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-17.84|||<|0.0001|TWO_SIDED|95.0|-21.05|-14.63||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-14.63|-21.05|<0.0001
91659769|NCT04239872|183214385|SUPERIORITY||Mean Difference (Net)|-0.05652||||0.3283|TWO_SIDED|95.0|-0.1762|0.06829||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06829|-0.1762|0.3283
91659770|NCT04239872|183214386|SUPERIORITY||Mean Difference (Net)|0.3411||||0.0058|TWO_SIDED|95.0|0.1189|0.5633||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5633|0.1189|0.0058
91659771|NCT04239872|183214387|SUPERIORITY||Mean Difference (Net)|0.2976||||0.0213|TWO_SIDED|95.0|0.05266|0.5426||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5426|0.05266|0.0213
91659772|NCT04239872|183214388|SUPERIORITY||Mean Difference (Net)|0.312||||0.014|TWO_SIDED|95.0|0.07454|0.5495||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5495|0.07454|0.014
91659773|NCT04239872|183214389|SUPERIORITY||Mean Difference (Net)|0.2524||||0.1393|TWO_SIDED|95.0|-0.09153|0.5962||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.5962|-0.09153|0.1393
91659774|NCT04239872|183214390|SUPERIORITY||Mean Difference (Net)|0.2921||||0.0009|TWO_SIDED|95.0|0.1414|0.4427||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.4427|0.1414|0.0009
91713395|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.84||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.|Wilcoxon test|||||||0.84
91713396|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.57||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.|Wilcoxon test|||||||0.57
91713397|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3052||||||The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3052
91713398|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of B cells at dose level 1.|Wilcoxon test|The reported p-value is representative of the changes in levels of B cells at dose level 1.||||||>0.9999
91659775|NCT04239872|183214391|SUPERIORITY||Mean Difference (Net)|0.2433||||0.0008|TWO_SIDED|95.0|0.1195|0.3671||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.3671|0.1195|0.0008
91659776|NCT04239872|183214392|SUPERIORITY||Mean Difference (Net)|0.3306||||0.1515|TWO_SIDED|95.0|-0.1356|0.7969||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.7969|-0.1356|0.1515
91659777|NCT04239872|183214393|SUPERIORITY||Mean Difference (Net)|0.04851||||0.1712|TWO_SIDED|95.0|-0.02327|0.1203||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.1203|-0.02327|0.1712
91713399|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of B cells at dose level 3.|Wilcoxon test|||||||0.13
91713400|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of B cells at dose level 4.|Wilcoxon test|||||||0.65
91524847|NCT01480596|182925246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|1.592||0.256|TWO_SIDED|95.0|-5.08|1.4|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||1.40|-5.08|0.256
91620767|NCT00696436|183134807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.54||||0.009|TWO_SIDED|95.0|-4.44|-0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.64|-4.44|0.009
91620768|NCT00696436|183134807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31|||<|0.001|TWO_SIDED|95.0|-6.25|-2.37||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.37|-6.25|<0.001
91620769|NCT00696436|183134807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.136|TWO_SIDED|95.0|-3.31|0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||0.45|-3.31|0.136
91620770|NCT00696436|183134807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.001|TWO_SIDED|95.0|-5.12|-1.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-1.27|-5.12|0.001
91620771|NCT00696436|183134808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-18.07|-11.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.76|-18.07|<0.001
91620772|NCT00696436|183134808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.55|||<|0.001|TWO_SIDED|95.0|-17.71|-11.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.40|-17.71|<0.001
91620773|NCT00696436|183134808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.008|TWO_SIDED|95.0|-6.17|-0.92||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.92|-6.17|0.008
91659778|NCT04239872|183214394|SUPERIORITY||Mean Difference (Net)|0.2789||||0.1188|TWO_SIDED|95.0|-0.07934|0.6371||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.6371|-0.07934|0.1188
91524848|NCT01480596|182925247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.082||95.0|0.87|19.02|||exact methods|||||19.02|0.87|0.082
91620774|NCT00696436|183134808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||<|0.001|TWO_SIDED|95.0|-8.09|-2.78||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.78|-8.09|<0.001
91620775|NCT00696436|183134808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18||||0.018|TWO_SIDED|95.0|-5.81|-0.55||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.55|-5.81|0.018
91620776|NCT00696436|183134808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||<|0.001|TWO_SIDED|95.0|-7.73|-2.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.42|-7.73|<0.001
91620777|NCT00696436|183134809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.36|||<|0.001|TWO_SIDED|95.0|-10.91|-7.81||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.81|-10.91|<0.001
91620778|NCT00696436|183134809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.58|||<|0.001|TWO_SIDED|95.0|-10.12|-7.04||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.04|-10.12|<0.001
91620779|NCT00696436|183134809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.011|TWO_SIDED|95.0|-2.99|-0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.40|-2.99|0.011
91659779|NCT04239872|183214395|SUPERIORITY||Mean Difference (Net)|0.8956|||<|0.0001|TWO_SIDED|95.0|0.7205|1.071||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.071|0.7205|<0.0001
91659780|NCT04239872|183214397|SUPERIORITY||Mean Difference (Net)|0.3199||||0.0475|TWO_SIDED|95.0|0.004686|0.6351||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.6351|0.004686|0.0475
91524849|NCT01480596|182925248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.827||95.0|0.05|4.35|||exact methods|||||4.35|0.05|0.827
91524850|NCT01480596|182925249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.184|TWO_SIDED|95.0|0.62|10.1|||Cochran-Mantel-Haenszel|||||10.10|0.62|0.184
91524851|NCT01480596|182925251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.228||0.175|TWO_SIDED|95.0|-4.2|0.8|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||0.80|-4.20|0.175
91524852|NCT01480596|182925251|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.267||0.31|TWO_SIDED|95.0|-3.89|1.28|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.28|-3.89|0.310
91659781|NCT04239872|183214398|SUPERIORITY||Mean Difference (Net)|50.38||||0.0004|TWO_SIDED|95.0|27.46|73.3||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||73.30|27.46|0.0004
91659782|NCT02819323|183214429|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
91659783|NCT02819323|183214429|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
91524853|NCT01480596|182925251|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|1.272||0.081|TWO_SIDED|95.0|-4.88|0.3|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||0.30|-4.88|0.081
91659784|NCT02819323|183214429|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|||||||0.046
91659785|NCT02819323|183214429|SUPERIORITY|||||||0.089|||||||Cochran-Mantel-Haenszel|||||||0.089
91659786|NCT01975948|183214430|OTHER|||||||0.047||||||Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).|Mixed Models Analysis|||One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.||||.047
91659787|NCT01975948|183214431|OTHER|||||||0.15|||||||Mixed Models Analysis|||Our calculations indicated that 50 physicians in each of the two groups will provide \>80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.||||0.15
91713401|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0698||||||The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0698
91524854|NCT01480596|182925252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.486||0.972|TWO_SIDED|95.0|-2.97|3.07|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||3.07|-2.97|0.972
91524855|NCT01480596|182925253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||1|TWO_SIDED|95.0|0.26|5.48|||exact methods|||||5.48|0.26|1.000
91524856|NCT01480596|182925254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.53|TWO_SIDED|95.0|0.03|2.89|||exact methods|||||2.89|0.03|0.530
91524857|NCT01480596|182925255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.175|TWO_SIDED|95.0|0.64|11.46|||Cochran-Mantel-Haenszel|||||11.46|0.64|0.175
91524858|NCT01480596|182925257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.245||0.423|TWO_SIDED|95.0|-3.56|1.53|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||1.53|-3.56|0.423
91524859|NCT01480596|182925257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.361||0.986|TWO_SIDED|95.0|-2.76|2.8|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||2.80|-2.76|0.986
91524860|NCT01480596|182925257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.43||0.848|TWO_SIDED|95.0|-3.21|2.65|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||2.65|-3.21|0.848
91524861|NCT01480596|182925263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.707||0.483|TWO_SIDED|95.0|-1.94|0.93|||Mixed Models Analysis||Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.|||0.93|-1.94|0.483
91524862|NCT01480596|182925263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.844||0.711|TWO_SIDED|95.0|-2.03|1.4|||Mixed Models Analysis||Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.|||1.40|-2.03|0.711
91524863|NCT01480596|182925264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.757||0.028|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||-0.20|-3.30|0.028
91524864|NCT01480596|182925264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.887||0.756|TWO_SIDED|95.0|-2.1|1.55|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.55|-2.10|0.756
91524865|NCT01480596|182925264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.909||0.775|TWO_SIDED|95.0|-2.12|1.59|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||1.59|-2.12|0.775
91524866|NCT00818363|182925265|SUPERIORITY||LS Mean Difference|-0.64||||0.303|TWO_SIDED|95.0|-1.74|0.47|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||0.47|-1.74|0.303
91620780|NCT00696436|183134809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.001|TWO_SIDED|95.0|-3.67|-1.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.02|-3.67|<0.001
91620781|NCT00696436|183134809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.166|TWO_SIDED|95.0|-2.19|0.38||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.38|-2.19|0.166
91620782|NCT00696436|183134809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.02|TWO_SIDED|95.0|-2.88|-0.24||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.24|-2.88|0.020
91620783|NCT00696436|183134810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.001|TWO_SIDED|95.0|-9.33|-5.69||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.69|-9.33|<0.001
91620784|NCT00696436|183134810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.21|||<|0.001|TWO_SIDED|95.0|-8.03|-4.39||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-4.39|-8.03|<0.001
91659788|NCT01975948|183214431|OTHER||Cohen'd|0.45||||0.03|TWO_SIDED|||||OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance|Mixed Models Analysis|||Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.||||.03
91659789|NCT01975948|183214432|OTHER|||||||0.993|||||||Mixed Models Analysis|||||||.993
91659790|NCT01975948|183214433|OTHER||Cohen'd|1.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
91659791|NCT01975948|183214433|OTHER|||||||0.03|||||||Generalized estimating equations (GEE)|We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.||Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.||||.03
91524867|NCT00818363|182925266|SUPERIORITY||LS Mean Difference|-10.25||||0.303|TWO_SIDED|95.0|-30.04|9.55|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||9.55|-30.04|0.303
91524868|NCT00633919|182925272|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.85
91659792|NCT01975948|183214434|OTHER||Cohen'd|1.44|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
91659793|NCT01975948|183214434|SUPERIORITY|||||||0.476||||||We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.||||.476
91659794|NCT01975948|183214435|SUPERIORITY||Cohen'd|3.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
91620785|NCT00696436|183134810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.005|TWO_SIDED|95.0|-3.69|-0.67||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.67|-3.69|0.005
91620786|NCT00696436|183134810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.69|-1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.64|-4.69|<0.001
91620787|NCT00696436|183134810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.257|TWO_SIDED|95.0|-2.39|0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.64|-2.39|0.257
91620788|NCT00696436|183134810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.017|TWO_SIDED|95.0|-3.39|-0.33||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.33|-3.39|0.017
91620789|NCT00696436|183134811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-17.3|-12.54||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.54|-17.30|<0.001
91620790|NCT00696436|183134811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.63|||<|0.001|TWO_SIDED|95.0|-15.99|-11.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.27|-15.99|<0.001
91620791|NCT00696436|183134811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.86||||0.005|TWO_SIDED|95.0|-4.85|-0.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.87|-4.85|0.005
91659795|NCT01975948|183214435|SUPERIORITY|||||||0.945||||||We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.||||.945
91659796|NCT01975948|183214436|OTHER|||||||0.742|||||||Mixed Models Analysis|||||||.742
91659797|NCT01975948|183214437|OTHER|||||||0.543|||||||Mixed Models Analysis|||||||.543
91659798|NCT01975948|183214438|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||.009
91620792|NCT00696436|183134811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.001|TWO_SIDED|95.0|-6.8|-2.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.73|-6.80|<0.001
91524869|NCT00633919|182925273|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.52
91659799|NCT01975948|183214439|OTHER|||||||0.213|||||||Mixed Models Analysis|||||||.213
91659800|NCT02008565|183214496|SUPERIORITY|||||||0.092||||||significance assessed at type 1 error alpha=0.05|Mixed Models Analysis|The models were adjusted for baseline Irritable Bowel Syndrome (IBS) status and clinical site.||||||0.092
91524870|NCT00633919|182925274|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
91620793|NCT00696436|183134811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.119|TWO_SIDED|95.0|-3.55|0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.40|-3.55|0.119
91620794|NCT00696436|183134811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-5.49|-1.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.45|-5.49|<0.001
91620795|NCT00696436|183134812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.81|||<|0.001|TWO_SIDED|95.0|-11.48|-8.13||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.13|-11.48|<0.001
91524871|NCT00633919|182925275|SUPERIORITY_OR_OTHER|||||||0.0486||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.0486
91620796|NCT00696436|183134812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||<|0.001|TWO_SIDED|95.0|-10.63|-7.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.30|-10.63|<0.001
91620797|NCT00696436|183134812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.006|TWO_SIDED|95.0|-3.39|-0.58||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.58|-3.39|0.006
91620798|NCT00696436|183134812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57|||<|0.001|TWO_SIDED|95.0|-4.0|-1.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.14|-4.00|<0.001
91620799|NCT00696436|183134812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.107|TWO_SIDED|95.0|-2.53|0.25||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.25|-2.53|0.107
91620800|NCT00696436|183134812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.017|TWO_SIDED|95.0|-3.15|-0.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.30|-3.15|0.017
91620801|NCT00696436|183134813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.56|-10.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.45|-15.56|<0.001
91620802|NCT00696436|183134813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.97|||<|0.001|TWO_SIDED|95.0|-14.51|-9.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.43|-14.51|<0.001
91659801|NCT00617305|183214509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.93|STANDARD_DEVIATION|241.978|||TWO_SIDED|95.0|-337.7|-160.2||||||Mean change from Baseline to Week 24||-160.2|-337.7|
91659802|NCT00617305|183214509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
91659803|NCT00617305|183214509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-253.83|STANDARD_DEVIATION|235.787|||TWO_SIDED|95.0|-334.8|-172.8||||||Mean change from Baseline to Week 24||-172.8|-334.8|
91659804|NCT00617305|183214509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
91659805|NCT00617305|183214510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.38|STANDARD_DEVIATION|7.954|||TWO_SIDED|95.0|-8.29|-2.46||||||Mean change from Baseline to Week 24||-2.46|-8.29|
91659806|NCT00617305|183214510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
91620803|NCT00696436|183134813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.194|TWO_SIDED|95.0|-3.56|0.72||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.72|-3.56|0.194
91620804|NCT00696436|183134813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.001|TWO_SIDED|95.0|-5.84|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.84|0.001
91620805|NCT00696436|183134813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.51|1.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.73|-2.51|0.720
91620806|NCT00696436|183134813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.62||||0.018|TWO_SIDED|95.0|-4.79|-0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.45|-4.79|0.018
91620807|NCT00696436|183134814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.64|||<|0.001|TWO_SIDED|95.0|-10.42|-6.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-6.87|-10.42|<0.001
91620808|NCT00696436|183134814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-9.52|-5.99||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.99|-9.52|<0.001
91620809|NCT00696436|183134814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.341|TWO_SIDED|95.0|-2.21|0.77||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.77|-2.21|0.341
91620810|NCT00696436|183134814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.003|TWO_SIDED|95.0|-3.8|-0.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.76|-3.80|0.003
91620811|NCT00696436|183134814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.821|TWO_SIDED|95.0|-1.3|1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.64|-1.30|0.821
91620812|NCT00696436|183134814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.071|TWO_SIDED|95.0|-2.89|0.12||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.12|-2.89|0.071
91659807|NCT00617305|183214510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.56|STANDARD_DEVIATION|8.589|||TWO_SIDED|95.0|-9.51|-3.61||||||Mean change from Baseline to Week 24||-3.61|-9.51|
91659808|NCT00617305|183214510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
91659809|NCT00617305|183214511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|4.442|||TWO_SIDED|95.0|-1.69|1.56||||||Mean change from Baseline to Week 24||1.56|-1.69|
91659810|NCT00617305|183214511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
91659811|NCT00617305|183214511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|4.527|||TWO_SIDED|95.0|-2.07|1.04||||||Mean change from Baseline to Week 24||1.04|-2.07|
91620813|NCT00696436|183134815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-17.96|-12.94||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.94|-17.96|<0.001
91620814|NCT00696436|183134815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|||<|0.001|TWO_SIDED|95.0|-16.42|-11.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.43|-16.42|<0.001
91620815|NCT00696436|183134815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.002|TWO_SIDED|95.0|-5.42|-1.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.22|-5.42|0.002
91620816|NCT00696436|183134815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||<|0.001|TWO_SIDED|95.0|-7.26|-2.97||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.97|-7.26|<0.001
91620817|NCT00696436|183134815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.091|TWO_SIDED|95.0|-3.88|0.29||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.29|-3.88|0.091
91620818|NCT00696436|183134815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.59|||<|0.001|TWO_SIDED|95.0|-5.72|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.72|<0.001
91620819|NCT00696436|183134816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.14|||<|0.001|TWO_SIDED|95.0|-11.92|-8.36||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.36|-11.92|<0.001
91620820|NCT00696436|183134816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.17|||<|0.001|TWO_SIDED|95.0|-10.94|-7.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.40|-10.94|<0.001
91620821|NCT00696436|183134816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.002|TWO_SIDED|95.0|-3.81|-0.82||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.82|-3.81|0.002
91620822|NCT00696436|183134816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|||<|0.001|TWO_SIDED|95.0|-4.24|-1.19||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.19|-4.24|<0.001
91659812|NCT00617305|183214511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
91659813|NCT00617305|183214512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|STANDARD_DEVIATION|1.053|||TWO_SIDED|95.0|0.43|1.25||||||Mean change from Baseline to Week 24||1.25|0.43|
91659814|NCT00617305|183214512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
91659815|NCT00617305|183214512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_DEVIATION|1.021|||TWO_SIDED|95.0|0.41|1.15||||||Mean change from Baseline to Week 24||1.15|0.41|
91620823|NCT00696436|183134816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.076|TWO_SIDED|95.0|-2.82|0.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.14|-2.82|0.076
91659816|NCT00617305|183214512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
91659817|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.2|STANDARD_DEVIATION|44.84|||TWO_SIDED|95.0|-3.9|28.4||||||Mean change from Baseline to Week 4 (LOCF)||28.4|-3.9|
91659818|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.8|STANDARD_DEVIATION|21.19|||TWO_SIDED|95.0|-26.0|41.5||||||Mean change from Baseline to Week 4 (LOCF)||41.5|-26.0|
91620824|NCT00696436|183134816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.024|TWO_SIDED|95.0|-3.25|-0.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.22|-3.25|0.024
91620825|NCT00696436|183134817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.66|-10.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.02|-15.66|<0.001
91620826|NCT00696436|183134817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.91|||<|0.001|TWO_SIDED|95.0|-14.72|-9.11||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.11|-14.72|<0.001
91620827|NCT00696436|183134817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.149|TWO_SIDED|95.0|-4.1|0.62||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.62|-4.10|0.149
91620828|NCT00696436|183134817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24|||<|0.001|TWO_SIDED|95.0|-6.65|-1.83||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.83|-6.65|<0.001
91620829|NCT00696436|183134817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.494|TWO_SIDED|95.0|-3.16|1.53||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.53|-3.16|0.494
91659819|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|107.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
91659820|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.7|STANDARD_DEVIATION|42.68|||TWO_SIDED|95.0|-2.7|26.2||||||Mean change from Baseline to Week 4 (LOCF)||26.2|-2.7|
91659821|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.6|STANDARD_DEVIATION|48.03|||TWO_SIDED|95.0|-32.0|87.2||||||Mean change from Baseline to Week 4 (LOCF)||87.2|-32.0|
91659822|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_DEVIATION|41.46|||TWO_SIDED|95.0|-1.4|28.5||||||Mean change from Baseline to Week 12 (LOCF)||28.5|-1.4|
91659823|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_DEVIATION|59.09|||TWO_SIDED|95.0|-91.5|96.5||||||Mean change from Baseline to Week 12 (LOCF)||96.5|-91.5|
91620830|NCT00696436|183134817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.007|TWO_SIDED|95.0|-5.72|-0.93||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.93|-5.72|0.007
91620831|NCT00696436|183134818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||<|0.001|TWO_SIDED|95.0|-10.03|-5.79||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.79|-10.03|<0.001
91659824|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91620832|NCT00696436|183134818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-10.1|-5.88||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.88|-10.10|<0.001
91620833|NCT00696436|183134818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.691|TWO_SIDED|95.0|-2.14|1.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.42|-2.14|0.691
91620834|NCT00696436|183134818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.39||||0.01|TWO_SIDED|95.0|-4.2|-0.57||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.57|-4.20|0.010
91620835|NCT00696436|183134818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.625|TWO_SIDED|95.0|-2.2|1.32||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.32|-2.20|0.625
91620836|NCT00696436|183134818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46||||0.008|TWO_SIDED|95.0|-4.27|-0.66||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.66|-4.27|0.008
91659825|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4|STANDARD_DEVIATION|42.83|||TWO_SIDED|95.0|-2.1|26.9||||||Mean change from Baseline to Week 12 (LOCF)||26.9|-2.1|
91713402|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NK cells at dose level 1.|Wilcoxon test|||||||0.63
91620837|NCT00696436|183134819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.98|||<|0.001|TWO_SIDED|95.0|3.15|7.88||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.88|3.15|<0.001
91620838|NCT00696436|183134819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.66|||<|0.001|TWO_SIDED|95.0|2.94|7.37||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.37|2.94|<0.001
91620839|NCT00696436|183134819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.032|TWO_SIDED|95.0|1.03|2.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.03|1.03|0.032
91620840|NCT00696436|183134819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.029|TWO_SIDED|95.0|1.04|2.06||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.06|1.04|0.029
91659826|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.4|STANDARD_DEVIATION|63.61|||TWO_SIDED|95.0|-59.6|98.4||||||Mean change from Baseline to Week 12 (LOCF)||98.4|-59.6|
91659827|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1|STANDARD_DEVIATION|48.67|||TWO_SIDED|95.0|0.5|35.6||||||Mean change from Baseline to Week 24 (LOCF)||35.6|0.5|
91659828|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.5|STANDARD_DEVIATION|29.56|||TWO_SIDED|95.0|-56.5|37.5||||||Mean change from Baseline to Week 24 (LOCF)||37.5|-56.5|
91659829|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91620841|NCT00696436|183134819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.89||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.89|0.96|0.080
91620842|NCT00696436|183134819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.071|TWO_SIDED|95.0|0.97|1.92||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.92|0.97|0.071
91620843|NCT00696436|183134820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|2.1|5.15||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||5.15|2.10|<0.001
91620844|NCT00696436|183134820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.86|4.54||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||4.54|1.86|<0.001
91659830|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0|STANDARD_DEVIATION|47.44|||TWO_SIDED|95.0|-1.0|31.1||||||Mean change from Baseline to Week 24 (LOCF)||31.1|-1.0|
91659831|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.8|STANDARD_DEVIATION|50.18|||TWO_SIDED|95.0|-52.5|72.1||||||Mean change from Baseline to Week 24 (LOCF)||72.1|-52.5|
91659832|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|77.24|||TWO_SIDED|95.0|-25.6|30.1||||||Mean change from Baseline to Week 36 (LOCF)||30.1|-25.6|
91659833|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.0|STANDARD_DEVIATION|93.16|||TWO_SIDED|95.0|-182.2|114.2||||||Mean change from Baseline to Week 36 (LOCF)||114.2|-182.2|
91659834|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91659835|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|78.5|||TWO_SIDED|95.0|-28.4|24.8||||||Mean change from Baseline to Week 36 (LOCF)||24.8|-28.4|
91659836|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8|STANDARD_DEVIATION|92.46|||TWO_SIDED|95.0|-128.6|101.0||||||Mean change from Baseline to Week 36 (LOCF)||101.0|-128.6|
91659837|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6|STANDARD_DEVIATION|82.07|||TWO_SIDED|95.0|-15.0|44.2||||||Mean change from Baseline to Week 48 (LOCF)||44.2|-15.0|
91620845|NCT00696436|183134820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.306|TWO_SIDED|95.0|0.83|1.8||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.80|0.83|0.306
91620846|NCT00696436|183134820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.132|TWO_SIDED|95.0|0.92|1.97||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.97|0.92|0.132
91620847|NCT00696436|183134820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.695|TWO_SIDED|95.0|0.74|1.58||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.58|0.74|0.695
91620848|NCT00696436|183134820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.381|TWO_SIDED|95.0|0.81|1.74||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.74|0.81|0.381
91620849|NCT00696436|183134821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.18|||<|0.001|TWO_SIDED|95.0|3.2|8.41||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||8.41|3.20|<0.001
91620850|NCT00696436|183134821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.43|||<|0.001|TWO_SIDED|95.0|2.73|7.19||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.19|2.73|<0.001
91620851|NCT00696436|183134821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.056|TWO_SIDED|95.0|0.99|1.94||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.94|0.99|0.056
91620852|NCT00696436|183134821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.036|TWO_SIDED|95.0|1.02|2.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.02|1.02|0.036
91620853|NCT00696436|183134821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.317|TWO_SIDED|95.0|0.85|1.66||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.66|0.85|0.317
91620854|NCT00696436|183134821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.234|TWO_SIDED|95.0|0.87|1.73||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.73|0.87|0.234
91620855|NCT01293006|183134830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.12|0.91|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.91|-0.12|
91659838|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.8|STANDARD_DEVIATION|126.75|||TWO_SIDED|95.0|-251.4|151.9||||||Mean change from Baseline to Week 48 (LOCF)||151.9|-251.4|
91620856|NCT01293006|183134833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||||TWO_SIDED|90.0|-1.3|3.36|||Difference of the Least Means Squares|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||3.36|-1.30|
91620857|NCT01293006|183134833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.08|0.5|||Difference of the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.08|
91620858|NCT01293006|183134833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|90.0|-5.77|7.41|||Difference of the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||7.41|-5.77|
91620859|NCT01293006|183134833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|90.0|0.0|0.63|||Difference of the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.63|0.00|
91620860|NCT01293006|183134834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||||TWO_SIDED|90.0|-0.6|2.04|||Difference of the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||2.04|-0.60|
91620861|NCT01293006|183134834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||||TWO_SIDED|90.0|0.33|3.77|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||3.77|0.33|
91659839|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91659840|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.4|STANDARD_DEVIATION|88.11|||TWO_SIDED|95.0|-22.4|37.3||||||Mean change from Baseline to Week 48 (LOCF)||37.3|-22.4|
91620862|NCT01293006|183134835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|90.0|-0.41|0.47|||Difference in the Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.47|-0.41|
91620863|NCT01293006|183134835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.53|0.27|||Difference of the Least Squares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.27|-0.53|
91620864|NCT01293006|183134835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|90.0|-0.61|0.18|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.18|-0.61|
91620865|NCT01293006|183134835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.32|0.98|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.98|-0.32|
91620866|NCT01293006|183134835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|90.0|-0.26|0.78|||Difference of the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.78|-0.26|
91620867|NCT01293006|183134835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.1|0.8|||Difference of the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.80|0.10|
91620868|NCT01293006|183134836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.5|0.31|||Difference in the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.31|-0.50|
91659841|NCT00617305|183214513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.4|STANDARD_DEVIATION|121.55|||TWO_SIDED|95.0|-177.3|124.5||||||Mean change from Baseline to Week 48 (LOCF)||124.5|-177.3|
91659842|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 4 (LOCF)||0.0|-1.1|
91659843|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.6|3.1||||||Mean change from Baseline to Week 4 (LOCF)||3.1|-1.6|
91659844|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
91620869|NCT03353753|183134852|SUPERIORITY||Hazard Ratio, log|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.25||Two-sided P-value|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.25|0.09|<0.0001
91620870|NCT03353753|183134853|SUPERIORITY|||||||0.0504||||||Two-sided P-value|Fisher Exact|||||||0.0504
91620871|NCT03353753|183134855|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.0004|TWO_SIDED|95.0|0.21|0.62||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.62|0.21|0.0004
91620872|NCT03353753|183134856|SUPERIORITY|||||||0.001||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.001
91620873|NCT03353753|183134857|SUPERIORITY|||||||0.004||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.004
91620874|NCT03353753|183134858|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91620875|NCT00600028|183134862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||0.001
91620876|NCT00600028|183134863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||.0001
91620877|NCT04397718|183135048|SUPERIORITY||Odds Ratio (OR)|1.19||||0.667|TWO_SIDED|95.0|0.46|3.06|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD|||3.06|0.46|0.667
91620878|NCT04397718|183135049|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.876|TWO_SIDED|95.0|0.58|1.49|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD.|||1.49|0.58|0.876
91620879|NCT04397718|183135050|SUPERIORITY||Odds Ratio (OR)|0.95||||0.991|TWO_SIDED|95.0|0.31|2.92|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||2.92|0.31|0.991
91659845|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.54|||TWO_SIDED|95.0|-0.9|0.1||||||Mean change from Baseline to Week 4 (LOCF)||0.1|-0.9|
91659846|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.52|||TWO_SIDED|95.0|-1.5|2.3||||||Mean change from Baseline to Week 4 (LOCF)||2.3|-1.5|
91659847|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.45|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 12 (LOCF)||0.0|-1.1|
91659848|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.38|||TWO_SIDED|95.0|-2.3|5.3||||||Mean change from Baseline to Week 12 (LOCF)||5.3|-2.3|
91659849|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91659850|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.67|||TWO_SIDED|95.0|-0.9|0.2||||||Mean change from Baseline to Week 12 (LOCF)||0.2|-0.9|
91620880|NCT04397718|183135051|SUPERIORITY||Quantile Regression|0.0||||0.841|TWO_SIDED|95.0|-2.03|4.11|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||4.11|-2.03|0.841
91620881|NCT04397718|183135052|SUPERIORITY||Quantile Regression|0.0||||0.746|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||0|0|0.746
91620882|NCT04397718|183135053|SUPERIORITY||Hazard Ratio (HR)|2.3||||0.1|TWO_SIDED|95.0|0.72|7.39|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD|||7.39|0.72|0.1
91620883|NCT04397718|183135054|SUPERIORITY||Odds Ratio (OR)|0.82||||0.425|TWO_SIDED|95.0|0.33|2.0|||Fisher Exact||||Logistical regression adjusted for age, hypertension, COPD, and baseline severity score.|2|0.33|0.425
91620884|NCT04397718|183135055|SUPERIORITY||Odds Ratio (OR)|1.22||||0.688|TWO_SIDED|95.0|0.44|3.42|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||3.42|0.44|0.688
91620885|NCT01778127|183135061|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
91620886|NCT01778127|183135061|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
91659851|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.17|||TWO_SIDED|95.0|-1.5|3.9||||||Mean change from Baseline to Week 12 (LOCF)||3.9|-1.5|
91620887|NCT01778127|183135061|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
91620888|NCT01778127|183135062|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
91620889|NCT01778127|183135062|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
91620890|NCT01778127|183135062|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
91620891|NCT01778127|183135063|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91620892|NCT01778127|183135063|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||||||0.63
91620893|NCT01778127|183135063|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
91620894|NCT01778127|183135064|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
91620895|NCT01778127|183135064|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
91620896|NCT01778127|183135064|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
91620897|NCT01778127|183135065|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
91620898|NCT01778127|183135065|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||t-test, 2 sided|||||||0.64
91620899|NCT01778127|183135065|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
91620900|NCT01778127|183135066|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
91620901|NCT01778127|183135066|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
91620902|NCT01778127|183135066|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
91620903|NCT01778127|183135067|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
91620904|NCT01778127|183135067|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
91620905|NCT01778127|183135067|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
91620906|NCT01778127|183135068|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
91620907|NCT01778127|183135068|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
91659852|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|1.81|||TWO_SIDED|95.0|-1.5|-0.2||||||Mean change from Baseline to Week 24 (LOCF)||-0.2|-1.5|
91659853|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.75|||TWO_SIDED|95.0|-1.8|0.6||||||Mean change from Baseline to Week 24 (LOCF)||0.6|-1.8|
91659854|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91659855|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.72|||TWO_SIDED|95.0|-1.4|-0.3||||||Mean change from Baseline to Week 24 (LOCF)||-0.3|-1.4|
91620908|NCT01778127|183135068|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
91620909|NCT01778127|183135069|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
91620910|NCT01778127|183135069|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
91620911|NCT01778127|183135069|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.54
91620912|NCT01778127|183135070|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||||||0.17
91620913|NCT01778127|183135070|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||t-test, 2 sided|||||||0.13
91620914|NCT01778127|183135070|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
91620915|NCT01778127|183135071|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
91620916|NCT01778127|183135071|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
91620917|NCT01778127|183135071|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
91620918|NCT01778127|183135072|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91620919|NCT01778127|183135072|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
91620920|NCT01778127|183135072|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
91620921|NCT01348425|183135075|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|4.1|<|0.01|TWO_SIDED|95.0|-2.0|3.5||Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents.|t-test, 2 sided|To test the hypothesis whether the percent change in stent length is contained within \[-10%, 10%\].||The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.||3.5|-2.0|<0.01
91620922|NCT01968954|183135085|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|-61.0|-53.1|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-53.1|-61.0|<0.001
91620923|NCT01968954|183135086|SUPERIORITY_OR_OTHER||LS mean difference|-36.2|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-38.8|-33.6|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-33.6|-38.8|<0.001
91620924|NCT01968954|183135086|SUPERIORITY_OR_OTHER||LS mean difference|-34.7|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-37.7|-31.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-31.7|-37.7|
91620925|NCT01968954|183135086|SUPERIORITY_OR_OTHER||LS mean difference|-29.0|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|95.0|-32.3|-25.7||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-25.7|-32.3|
91620926|NCT01968954|183135087|SUPERIORITY_OR_OTHER||LS mean difference|-51.6|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-55.2|-48.1|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-48.1|-55.2|<0.001
91620927|NCT01968954|183135087|SUPERIORITY_OR_OTHER||LS mean Difference|-50.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-54.9|-46.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.4|-54.9|
91620928|NCT01968954|183135087|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-45.8|-36.5||||||Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.5|-45.8|
91659856|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|0.71|||TWO_SIDED|95.0|-1.4|0.4||||||Mean change from Baseline to Week 24 (LOCF)||0.4|-1.4|
91659857|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.2|0.1||||||Mean change from Baseline to Week 36 (LOCF)||0.1|-1.2|
91620929|NCT01968954|183135088|SUPERIORITY_OR_OTHER||LS mean difference|-51.5|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-55.1|-47.9|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-47.9|-55.1|<0.001
91620930|NCT01968954|183135088|SUPERIORITY_OR_OTHER||LS mean difference|-50.6|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-54.6|-46.6||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.6|-54.6|
91620931|NCT01968954|183135088|SUPERIORITY_OR_OTHER||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.2|-36.3||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.3|-45.2|
91620932|NCT01968954|183135089|SUPERIORITY_OR_OTHER||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|16.55||0.86|TWO_SIDED|95.0|-35.4|29.5|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||29.5|-35.4|0.860
91620933|NCT01968954|183135089|SUPERIORITY_OR_OTHER||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|25.11|||TWO_SIDED|95.0|-47.2|51.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||51.4|-47.2|
91620934|NCT01968954|183135089|SUPERIORITY_OR_OTHER||LS mean difference|12.9|STANDARD_ERROR_OF_MEAN|29.25|||TWO_SIDED|95.0|-44.5|70.4||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||70.4|-44.5|
91620935|NCT01968954|183135090|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.4|7.0|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||7.0|2.4|<0.001
91659858|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|-2.2|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-2.2|
91659859|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91524872|NCT00633919|182925276|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
91524873|NCT03338621|182925281|SUPERIORITY||Cox Proportional Hazard|2.93|||<|0.001|TWO_SIDED|95.0|2.17|3.96|||Log Rank|||||3.96|2.17|<0.001
91620936|NCT01968954|183135090|SUPERIORITY_OR_OTHER||LS mean difference|6.8|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|4.5|9.1||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||9.1|4.5|
91620937|NCT01968954|183135090|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|0.9|5.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.8|0.9|
91659860|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.85|||TWO_SIDED|95.0|-1.0|0.2||||||Mean change from Baseline to Week 36 (LOCF)||0.2|-1.0|
91659861|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.4|3.0||||||Mean change from Baseline to Week 36 (LOCF)||3.0|-1.4|
91659862|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|2.12|||TWO_SIDED|95.0|-1.4|0.1||||||Mean change from Baseline to Week 48 (LOCF)||0.1|-1.4|
91620938|NCT01968954|183135091|SUPERIORITY_OR_OTHER||LS mean difference|-59.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-63.4|-54.8|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-54.8|-63.4|<0.001
91659863|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-4.5|6.5||||||Mean change from Baseline to Week 48 (LOCF)||6.5|-4.5|
91659864|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91659865|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.3|||TWO_SIDED|95.0|-1.3|0.3||||||Mean change from Baseline to Week 48 (LOCF)||0.3|-1.3|
91659866|NCT00617305|183214514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|3.03|||TWO_SIDED|95.0|-3.0|4.6||||||Mean change from Baseline to Week 48 (LOCF)||4.6|-3.0|
91659867|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|3.98|||TWO_SIDED|95.0|-2.7|0.4||||||Mean change from Baseline to Week 12 (LOCF)||0.4|-2.7|
91659868|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|4.86|||TWO_SIDED|95.0|-6.5|9.0||||||Mean change from Baseline to Week 12 (LOCF)||9.0|-6.5|
91659869|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91659870|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.09|||TWO_SIDED|95.0|-2.3|0.6||||||Mean change from Baseline to Week 12 (LOCF)||0.6|-2.3|
91659871|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|4.45|||TWO_SIDED|95.0|-4.9|6.1||||||Mean change from Baseline to Week 12 (LOCF)||6.1|-4.9|
91659872|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|-2.7|1.1||||||Mean change from Baseline to Week 24 (LOCF)||1.1|-2.7|
91659873|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.03|||TWO_SIDED|95.0|-7.7|5.2||||||Mean change from Baseline to Week 24 (LOCF)||5.2|-7.7|
91620939|NCT01968954|183135092|SUPERIORITY_OR_OTHER||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-58.0|-39.3|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-39.3|-58.0|<0.001
91620940|NCT01968954|183135093|SUPERIORITY_OR_OTHER||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-60.8|-51.2||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-51.2|-60.8|
91620941|NCT01968954|183135093|SUPERIORITY_OR_OTHER||LS mean difference|-46.4|STANDARD_ERROR_OF_MEAN|2.77|||TWO_SIDED|95.0|-51.8|-41.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-41.0|-51.8|
91620942|NCT01968954|183135094|SUPERIORITY_OR_OTHER||LS mean difference|-57.6|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-63.1|-52.0||||||TG \<200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-52.0|-63.1|
91620943|NCT01968954|183135094|SUPERIORITY_OR_OTHER||LS mean difference|-47.7|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-53.9|-41.5||||||TG \<200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-41.5|-53.9|
91659874|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91659875|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|4.84|||TWO_SIDED|95.0|-2.6|0.9||||||Mean change from Baseline to Week 24 (LOCF)||0.9|-2.6|
91659876|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.51|||TWO_SIDED|95.0|-5.8|3.0||||||Mean change from Baseline to Week 24 (LOCF)||3.0|-5.8|
91659877|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.2|||TWO_SIDED|95.0|-2.3|1.7||||||Mean change from Baseline to Week 36 (LOCF)||1.7|-2.3|
91659878|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.65|||TWO_SIDED|95.0|-8.1|6.6||||||Mean change from Baseline to Week 36 (LOCF)||6.6|-8.1|
91659879|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91659880|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.07|||TWO_SIDED|95.0|-2.2|1.5||||||Mean change from Baseline to Week 36 (LOCF)||1.5|-2.2|
91659881|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.02|||TWO_SIDED|95.0|-5.8|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-5.8|
91659882|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.33|||TWO_SIDED|95.0|-2.8|2.1||||||Mean change from Baseline to Week 48 (LOCF)||2.1|-2.8|
91659883|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|6.86|||TWO_SIDED|95.0|-11.4|10.4||||||Mean change from Baseline to Week 48 (LOCF)||10.4|-11.4|
91659884|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91659885|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.28|||TWO_SIDED|95.0|-2.7|1.9||||||Mean change from Baseline to Week 48 (LOCF)||1.9|-2.7|
91659886|NCT00617305|183214515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|5.94|||TWO_SIDED|95.0|-8.0|6.8||||||Mean change from Baseline to Week 48 (LOCF)||6.8|-8.0|
91659887|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
91659888|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
91659889|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.49||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
91620944|NCT01968954|183135094|SUPERIORITY_OR_OTHER||LS mean difference|-49.3|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-58.9|-39.8||||||TG \>=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-39.8|-58.9|
91620945|NCT01968954|183135094|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|95.0|-52.2|-30.1||||||TG \>=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-30.1|-52.2|
91620946|NCT01968954|183135095|SUPERIORITY_OR_OTHER||LS mean difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
91620947|NCT01968954|183135095|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
91620948|NCT01968954|183135095|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
91620949|NCT01968954|183135096|SUPERIORITY_OR_OTHER||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|1.8|5.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.7|1.8|
91620950|NCT01968954|183135096|SUPERIORITY_OR_OTHER||LS mean difference|4.9|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|3.1|6.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||6.7|3.1|
91620951|NCT01968954|183135096|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|0.7|4.6||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||4.6|0.7|
91620952|NCT01968954|183135097|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-1.9|1.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||1.7|-1.9|
91620953|NCT01968954|183135097|SUPERIORITY_OR_OTHER||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-0.1|3.9||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.9|-0.1|
91620954|NCT01968954|183135097|SUPERIORITY_OR_OTHER||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-1.0|3.1||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.1|-1.0|
91620955|NCT01968954|183135098|SUPERIORITY_OR_OTHER||LS-Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
91620956|NCT01968954|183135098|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
91620957|NCT01968954|183135098|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
91659890|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
91659891|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.63||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91620958|NCT01968954|183135099|SUPERIORITY_OR_OTHER||LS mean difference|-64.2|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-69.1|-59.2||||||TG \<200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-59.2|-69.1|
91620959|NCT01968954|183135099|SUPERIORITY_OR_OTHER||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|5.99|||TWO_SIDED|95.0|-71.4|-47.7||||||TG \>=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-47.7|-71.4|
91620960|NCT01968954|183135100|SUPERIORITY_OR_OTHER||LS mean difference|-63.4|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-68.0|-58.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-58.8|-68.0|
91620961|NCT01968954|183135101|SUPERIORITY_OR_OTHER||LS mean difference|-67.1|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|95.0|-72.2|-62.1||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-62.1|-72.2|
91659892|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91659893|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.64||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91659894|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
91659895|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.83||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91659896|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91659897|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.81||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91659898|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
91659899|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.92||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91659900|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91659901|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91659902|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
91659903|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91659904|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91659905|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.88||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91659906|NCT00617305|183214517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
91713403|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of NK cells at dose level 3.|Wilcoxon test|||||||0.74
91713404|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of NK cells at dose level 4.|Wilcoxon test|||||||0.13
91659907|NCT01059903|183214529|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9028|||||TWO_SIDED|90.0|0.8411|0.969|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9690|0.8411|
91659908|NCT01059903|183214530|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9506|||||TWO_SIDED|90.0|0.8833|1.0231|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0231|0.8833|
91659909|NCT01059903|183214531|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9046|||||TWO_SIDED|90.0|0.8437|0.9699|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9699|0.8437|
91659910|NCT03555305|183214544|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.961|||||TWO_SIDED|90.0|0.886|1.04|||Linear mixed-effects model|||||1.04|0.886|
91659911|NCT03555305|183214545|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.874|1.02|||Linear mixed-effects model|||||1.02|0.874|
91659912|NCT04544787|183214558|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
91620962|NCT01968954|183135102|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-74.7|-64.6||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-64.6|-74.7|
91620963|NCT01968954|183135103|SUPERIORITY_OR_OTHER||LS mean difference|-47.3|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-50.7|-43.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-43.8|-50.7|
91620964|NCT01968954|183135104|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-12.9|-8.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.3|-12.9|
91620965|NCT01968954|183135105|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|1.4|3.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.5|1.4|
91620966|NCT01968954|183135106|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
91620967|NCT01968954|183135106|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
91620968|NCT01968954|183135106|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.4|-1.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.0|-1.4|
91620969|NCT01968954|183135107|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
91659913|NCT04544787|183214558|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
91659914|NCT04544787|183214558|OTHER|||||||0.3769|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3769
91620970|NCT01968954|183135107|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
91620971|NCT01968954|183135107|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.2|-0.3|
91620972|NCT01968954|183135108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.0|||||TWO_SIDED|95.0|13.86|41.64||||||Week 12||41.64|13.86|
91620973|NCT01968954|183135108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8|||||TWO_SIDED|95.0|9.32|23.56||||||Week 24||23.56|9.32|
91620974|NCT01968954|183135108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.8|||||TWO_SIDED|95.0|6.36|15.24||||||Week 52||15.24|6.36|
91620975|NCT01968954|183135109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|95.2|||||TWO_SIDED|95.0|52.09|173.91||||||Week 12||173.91|52.09|
91620976|NCT01968954|183135109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.2|||||TWO_SIDED|95.0|55.81|225.52||||||Week 24||225.52|55.81|
91620977|NCT01968954|183135109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.1|||||TWO_SIDED|95.0|17.13|49.49||||||Week 52||49.49|17.13|
91620978|NCT00547638|183135123|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of DERMABOND HVD successful subjects) does not exceed 8%.|Difference in Proportion of Successes|-7.9|||||TWO_SIDED|95.0|-17.7|1.0|||Gart-Nam||The value for the Estimated Parameter is expressed as a percentage and is defined as the difference in the proportion of sucesses between study groups.|||1.0|-17.7|
91620979|NCT00547638|183135124|SUPERIORITY_OR_OTHER|||||||0.457||||||The total mHCS scores are summarized as proportion of subjects with good outcome (total scores of zero) and a comparison of treatment groups by Fisher Exact Test was performed to confirm differences in groups.|Fisher Exact|||||||0.457
91620980|NCT00547638|183135125|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 14 and Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
91620981|NCT00547638|183135125|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
91620982|NCT00547638|183135126|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.188
91659915|NCT04544787|183214558|OTHER|||||||0.3083|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3083
91659916|NCT04544787|183214558|OTHER|||||||0.4975|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||0.4975
91659917|NCT04544787|183214558|OTHER|||||||1|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||1.0000
91659918|NCT04544787|183214558|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
91659919|NCT04544787|183214558|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
91659920|NCT04544787|183214558|OTHER|||||||0.1571|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.1571
91659921|NCT04544787|183214558|OTHER|||||||0.296|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.2960
91659922|NCT04544787|183214559|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.9|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 (mOPV2) control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.9|
91620983|NCT00547638|183135126|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.883
91620984|NCT00547638|183135127|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
91620985|NCT01963208|183135135|OTHER||Median Difference (Final Values)|-7.06||||0.1788|TWO_SIDED|95.0|-17.44|3.52||The null hypothesis is that there is no difference between the distributions of the two treatment groups with respect to percent change in seizure frequency.|Rank ANCOVA|||||3.52|-17.44|0.1788
91620986|NCT00438399|183135151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.0003
91620987|NCT00438399|183135151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.007
91659923|NCT04544787|183214559|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.8|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.8|
91659924|NCT02100228|183214602|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.0||||0.0151|TWO_SIDED|95.0|0.0|0.6425||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||0.6425|0.0000|0.0151
91659925|NCT02100228|183214604|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.4905||||0.3378|TWO_SIDED|95.0|0.1046|2.0678||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||2.0678|0.1046|0.3378
91659926|NCT02100228|183214605|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.83||||0.6851|TWO_SIDED|95.0|0.3433|1.8916||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||1.8916|0.3433|0.6851
91524874|NCT02037438|182925285|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.03|STANDARD_ERROR_OF_MEAN|0.075||0.687|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.687
91524875|NCT02037438|182925286|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|-0.007|STANDARD_ERROR_OF_MEAN|0.539||0.989|TWO_SIDED||||||see Comments|Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate||||||0.989
91659927|NCT02100228|183214606|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|1.9841|||>|0.9999|TWO_SIDED|95.0|0.1866|53.9968||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||53.9968|0.1866|>0.9999
91524876|NCT02037438|182925287|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.114|STANDARD_ERROR_OF_MEAN|0.141||0.417|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.417
91713405|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0127||||||The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0127
91524877|NCT02037438|182925288|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.057|STANDARD_ERROR_OF_MEAN|0.078||0.468|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.468
91524878|NCT02037438|182925289|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.177|STANDARD_ERROR_OF_MEAN|0.061||0.003|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.003
91620988|NCT00438399|183135151|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||<0.0001
91620989|NCT03334396|183135155|SUPERIORITY||Odds Ratio (OR)|2.61||||0.02|TWO_SIDED|95.0|1.17|5.84|||Regression, Logistic|||||5.84|1.17|0.020
91620990|NCT03334396|183135155|SUPERIORITY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|1.93|8.7|||Regression, Logistic|||||8.70|1.93|<0.001
91659928|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.91|0.60|0.005
91659929|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.78|TWO_SIDED|95.0|0.33|2.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||2.30|0.33|0.780
91659930|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.164|TWO_SIDED|95.0|0.75|5.33||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||5.33|0.75|0.164
91659931|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.919|TWO_SIDED|95.0|0.23|5.17||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model.||5.17|0.23|0.919
91713406|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 1.|Wilcoxon test|||||||0.63
91713407|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.41||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 3.|Wilcoxon test|||||||0.41
91620991|NCT03334396|183135156|SUPERIORITY||Odds Ratio (OR)|2.72||||0.014|TWO_SIDED|95.0|1.23|6.01|||Regression, Logistic|||||6.01|1.23|0.014
91713408|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.07||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 4.|Wilcoxon test|||||||0.07
91713409|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0654||||||The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0654
91620992|NCT03334396|183135157|SUPERIORITY||Odds Ratio (OR)|2.03||||0.032|TWO_SIDED|95.0|1.06|3.88|||Regression, Logistic|||||3.88|1.06|0.032
91620993|NCT03334396|183135157|SUPERIORITY||Odds Ratio (OR)|2.46||||0.006|TWO_SIDED|95.0|1.29|4.67|||Regression, Logistic|||||4.67|1.29|0.006
91620994|NCT03334396|183135157|SUPERIORITY||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.01|6.89|||Regression, Logistic|||||6.89|2.01|<0.001
91620995|NCT03334396|183135158|SUPERIORITY||Odds Ratio (OR)|1.73||||0.21|TWO_SIDED|95.0|0.74|4.05|||Regression, Logistic|||||4.05|0.74|0.210
91620996|NCT03334396|183135158|SUPERIORITY||Odds Ratio (OR)|2.5||||0.029|TWO_SIDED|95.0|1.1|5.7|||Regression, Logistic|||||5.70|1.10|0.029
91620997|NCT03334396|183135158|SUPERIORITY||Odds Ratio (OR)|4.13|||<|0.001|TWO_SIDED|95.0|1.91|8.91|||Regression, Logistic|||||8.91|1.91|<0.001
91620998|NCT03334396|183135159|SUPERIORITY||Mean Difference (Final Values)|-13.4|STANDARD_ERROR_OF_MEAN|5.78||0.021|TWO_SIDED|95.0|-24.77|-2.03|||Mixed Models Analysis|||||-2.03|-24.77|0.021
91659932|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.051|TWO_SIDED|95.0|1.0|3.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1.||3.30|1.00|0.051
91659933|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42||||0.076|TWO_SIDED|95.0|0.86|22.74||A priori threshold for statistical significance was p\<0.05|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1.||22.74|0.86|0.076
91659934|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.075|TWO_SIDED|95.0|0.13|1.1||A priori threshold fors tatistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||1.10|0.13|0.075
91659935|NCT00322465|183214629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.93|7.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||7.98|1.93|<0.001
91620999|NCT03334396|183135159|SUPERIORITY||Mean Difference (Final Values)|-17.07|STANDARD_ERROR_OF_MEAN|5.57||0.002|TWO_SIDED|95.0|-28.05|-6.1|||Mixed Models Analysis|||||-6.10|-28.05|0.002
91659936|NCT00322465|183214630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.009|TWO_SIDED|95.0|0.06|0.66||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.66|0.06|0.009
91621000|NCT03334396|183135159|SUPERIORITY||Mean Difference (Final Values)|-24.54|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-34.84|-14.24|||Mixed Models Analysis|||||-14.24|-34.84|<0.001
91621001|NCT03334396|183135160|SUPERIORITY||Odds Ratio (OR)|4.28||||0.025|TWO_SIDED|95.0|1.2|15.24|||Regression, Logistic|||||15.24|1.20|0.025
91621002|NCT03334396|183135160|SUPERIORITY||Odds Ratio (OR)|6.14||||0.004|TWO_SIDED|95.0|1.79|20.99|||Regression, Logistic|||||20.99|1.79|0.004
91621003|NCT03334396|183135160|SUPERIORITY||Odds Ratio (OR)|8.76|||<|0.001|TWO_SIDED|95.0|2.68|28.58|||Regression, Logistic|||||28.58|2.68|<0.001
91621004|NCT03334396|183135161|SUPERIORITY||Odds Ratio (OR)|1.6||||0.246|TWO_SIDED|95.0|0.72|3.56|||Regression, Logistic|||||3.56|0.72|0.246
91621005|NCT03334396|183135161|SUPERIORITY||Odds Ratio (OR)|1.73||||0.169|TWO_SIDED|95.0|0.79|3.77|||Regression, Logistic|||||3.77|0.79|0.169
91621006|NCT03334396|183135161|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.001|TWO_SIDED|95.0|1.82|7.18|||Regression, Logistic|||||7.18|1.82|<0.001
91621007|NCT03334396|183135162|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.103|TWO_SIDED|95.0|-0.82|0.08|||Mixed Models Analysis|||||0.08|-0.82|0.103
91621008|NCT03334396|183135162|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.352|TWO_SIDED|95.0|-0.65|0.23|||Mixed Models Analysis|||||0.23|-0.65|0.352
91621009|NCT03334396|183135162|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.006|TWO_SIDED|95.0|-1.0|-0.17|||Mixed Models Analysis|||||-0.17|-1.00|0.006
91621010|NCT03334396|183135163|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.005|TWO_SIDED|95.0|-1.84|-0.32|||Mixed Models Analysis|||||-0.32|-1.84|0.005
91621011|NCT03334396|183135163|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.48|0.0|||Mixed Models Analysis|||||0.00|-1.48|0.051
91659937|NCT00322465|183214630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.074|TWO_SIDED|95.0|0.92|6.22||A priori threshold for statistical signficance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||6.22|0.92|0.074
91621012|NCT03334396|183135163|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.002|TWO_SIDED|95.0|-1.79|-0.39|||Mixed Models Analysis|||||-0.39|-1.79|0.002
91621013|NCT03334396|183135164|SUPERIORITY||Odds Ratio (OR)|1.9||||0.019|TWO_SIDED|95.0|1.11|3.25|||Regression, Logistic|||||3.25|1.11|0.019
91621014|NCT03334396|183135164|SUPERIORITY||Mean Difference (Final Values)|2.44|||<|0.001|TWO_SIDED|95.0|1.44|4.14|||Regression, Logistic|||||4.14|1.44|<0.001
91621015|NCT03334396|183135164|SUPERIORITY||Mean Difference (Final Values)|4.18|||<|0.001|TWO_SIDED|95.0|2.51|6.96|||Regression, Logistic|||||6.96|2.51|<0.001
91621016|NCT03334396|183135165|SUPERIORITY||Odds Ratio (OR)|1.98||||0.424|TWO_SIDED|95.0|0.37|10.63|||Regression, Logistic|||||10.63|0.37|0.424
91621017|NCT03334396|183135165|SUPERIORITY||Odds Ratio (OR)|2.89||||0.182|TWO_SIDED|95.0|0.61|13.75|||Regression, Logistic|||||13.75|0.61|0.182
91621018|NCT03334396|183135165|SUPERIORITY||Odds Ratio (OR)|1.94||||0.441|TWO_SIDED|95.0|0.36|10.41|||Regression, Logistic|||||10.41|0.36|0.441
91621019|NCT03334396|183135166|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|3.17||0.093|TWO_SIDED|95.0|-11.57|0.9|||Mixed Models Analysis|||||0.90|-11.57|0.093
91659938|NCT00322465|183214631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.032|TWO_SIDED|95.0|0.66|0.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|No other independent variables were included in the model.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.||0.98|0.66|0.032
91713410|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 1.|Wilcoxon test|||||||0.38
91713411|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.21||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 3.|Wilcoxon test|||||||0.21
91621020|NCT03334396|183135166|SUPERIORITY||Mean Difference (Final Values)|-7.97|STANDARD_ERROR_OF_MEAN|3.07||0.01|TWO_SIDED|95.0|-14.01|-1.92|||Mixed Models Analysis|||||-1.92|-14.01|0.010
91621021|NCT03334396|183135166|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-20.46|-9.13|||Mixed Models Analysis|||||-9.13|-20.46|<0.001
91621022|NCT03334396|183135167|SUPERIORITY||Odds Ratio (OR)|1.17||||0.874|TWO_SIDED|95.0|0.17|7.77|||Regression, Logistic|||||7.77|0.17|0.874
91621023|NCT03334396|183135167|SUPERIORITY||Odds Ratio (OR)|2.88||||0.176|TWO_SIDED|95.0|0.62|13.36|||Regression, Logistic|||||13.36|0.62|0.176
91621024|NCT03334396|183135167|SUPERIORITY||Odds Ratio (OR)|2.72||||0.201|TWO_SIDED|95.0|0.59|12.65|||Regression, Logistic|||||12.65|0.59|0.201
91621025|NCT03334396|183135168|SUPERIORITY||Mean Difference (Final Values)|-5.99|STANDARD_ERROR_OF_MEAN|2.88||0.039|TWO_SIDED|95.0|-11.67|-0.31|||Mixed Models Analysis|||||-0.31|-11.67|0.039
91621026|NCT03334396|183135168|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.8||0.058|TWO_SIDED|95.0|-10.86|0.18|||Mixed Models Analysis|||||0.18|-10.86|0.058
91621027|NCT03334396|183135168|SUPERIORITY||Mean Difference (Final Values)|-11.16|STANDARD_DEVIATION|2.63|<|0.001|TWO_SIDED|95.0|-16.33|-5.98|||Mixed Models Analysis|||||-5.98|-16.33|<0.001
91621028|NCT03334396|183135169|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
91621029|NCT03334396|183135169|SUPERIORITY|||||||0.799|||||||Fisher Exact|||||||0.799
91621030|NCT03334396|183135169|SUPERIORITY|||||||0.782|||||||Fisher Exact|||||||0.782
91621031|NCT03334396|183135170|SUPERIORITY||Mean Difference (Final Values)|-19.25|STANDARD_ERROR_OF_MEAN|7.33||0.009|TWO_SIDED|95.0|-33.69|-4.81|||Mixed Models Analysis|||||-4.81|-33.69|0.009
91621032|NCT03334396|183135170|SUPERIORITY||Mean Difference (Final Values)|-17.39|STANDARD_ERROR_OF_MEAN|7.13||0.015|TWO_SIDED|95.0|-31.43|-3.35|||Mixed Models Analysis|||||-3.35|-31.43|0.015
91621033|NCT03334396|183135170|SUPERIORITY||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|6.71|<|0.001|TWO_SIDED|95.0|-37.71|-11.3|||Mixed Models Analysis|||||-11.30|-37.71|<0.001
91621034|NCT03334396|183135171|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.19||0.028|TWO_SIDED|95.0|-4.98|-0.29|||Mixed Models Analysis|||||-0.29|-4.98|0.028
91621035|NCT03334396|183135171|SUPERIORITY||Mean Difference (Final Values)|-3.58|STANDARD_ERROR_OF_MEAN|1.17||0.003|TWO_SIDED|95.0|-5.89|-1.27|||Mixed Models Analysis|||||-1.27|-5.89|0.003
91621036|NCT03334396|183135171|SUPERIORITY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.33|-2.99|||Mixed Models Analysis|||||-2.99|-7.33|<0.001
91621037|NCT03334396|183135172|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.069|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.069
91621038|NCT03334396|183135172|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.066
91621039|NCT03334396|183135172|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.73|-0.19|||Mixed Models Analysis|||||-0.19|-0.73|<0.001
91621040|NCT03334396|183135173|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.43||0.305|TWO_SIDED|95.0|-1.3|0.41|||Mixed Models Analysis|||HADS Anxiety||0.41|-1.30|0.305
91621041|NCT03334396|183135173|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.77|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.77|0.029
91621042|NCT03334396|183135173|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.004|TWO_SIDED|95.0|-1.93|-0.36|||Mixed Models Analysis|||HADS Anxiety||-0.36|-1.93|0.004
91659939|NCT01073657|183214637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|STANDARD_DEVIATION|33.9||0.0059|TWO_SIDED|95.0|14.0|38.0|||t-test, 2 sided|||||38|14|0.0059
91659940|NCT00854100|183214638|SUPERIORITY||Least Squares Mean Difference|0.5||||0.746|TWO_SIDED|95.0|-2.4|3.4|||ANCOVA|||||3.4|-2.4|0.746
91659941|NCT00854100|183214638|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.227|TWO_SIDED|95.0|-4.8|1.1|||ANCOVA|||||1.1|-4.8|0.227
91659942|NCT00854100|183214639|SUPERIORITY||Least Squares Mean Difference|0.0||||0.918|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.918
91659943|NCT00854100|183214639|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.167|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.167
91659944|NCT02242201|183214647|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
91659945|NCT02242201|183214647|SUPERIORITY|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||||||0.662
91659946|NCT02242201|183214647|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
91659947|NCT02242201|183214648|SUPERIORITY|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.948
91659948|NCT02242201|183214648|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.880
91659949|NCT02242201|183214648|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.802
91659950|NCT02242201|183214648|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.179
91659951|NCT02242201|183214648|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.837
91659952|NCT02242201|183214648|SUPERIORITY|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.142
91659953|NCT02242201|183214648|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.010
91659954|NCT02242201|183214648|SUPERIORITY|||||||0.516|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.516
91659955|NCT02242201|183214648|SUPERIORITY|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.052
91659956|NCT02242201|183214648|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.840
91659957|NCT02242201|183214648|SUPERIORITY|||||||0.744|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.744
91659958|NCT02242201|183214648|SUPERIORITY|||||||0.501|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.501
91621043|NCT03334396|183135173|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.113|TWO_SIDED|95.0|-1.51|0.16|||Mixed Models Analysis|||HADS Depression||0.16|-1.51|0.113
91621044|NCT03334396|183135173|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.42||0.014|TWO_SIDED|95.0|-1.85|-0.22|||Mixed Models Analysis|||HADS Depression||-0.22|-1.85|0.014
91621045|NCT03334396|183135173|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.39||0.004|TWO_SIDED|95.0|-1.91|-0.37|||Mixed Models Analysis|||HADS Depression||-0.37|-1.91|0.004
91621046|NCT03334396|183135174|SUPERIORITY||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.89||0.015|TWO_SIDED|95.0|-3.92|-0.42|||Mixed Models Analysis|||||-0.42|-3.92|0.015
91659959|NCT02242201|183214648|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.358
91659960|NCT02242201|183214648|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.536
91659961|NCT02242201|183214648|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.110
91659962|NCT02242201|183214648|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.313
91659963|NCT02242201|183214648|SUPERIORITY|||||||0.893|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.893
91659964|NCT02242201|183214648|SUPERIORITY|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.232
91659965|NCT02242201|183214649|SUPERIORITY|||||||0.772|||||||Kruskal-Wallis|||||||0.772
91659966|NCT02242201|183214650|SUPERIORITY|||||||0.251|||||||Regression, Cox|||Baseline||||0.251
91659967|NCT02242201|183214650|SUPERIORITY|||||||0.3|||||||Regression, Cox|||3 month follow-up||||0.300
91659968|NCT02242201|183214650|SUPERIORITY|||||||0.113|||||||Regression, Cox|||Baseline vs 3 months||||0.113
91659969|NCT02242201|183214650|SUPERIORITY|||||||0.147|||||||Regression, Cox|||Baseline vs 3 months||||0.147
91621047|NCT03334396|183135174|SUPERIORITY||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.87||0.036|TWO_SIDED|95.0|-3.56|-0.12|||Mixed Models Analysis|||||-0.12|-3.56|0.036
91621048|NCT03334396|183135174|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-5.91|-2.69|||Mixed Models Analysis|||||-2.69|-5.91|<0.001
91621049|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.7||0.136|TWO_SIDED|95.0|-9.39|1.29|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.29|-9.39|0.136
91621050|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|2.76||0.898|TWO_SIDED|95.0|-5.81|5.1|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||5.10|-5.81|0.898
91621051|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.49||0.174|TWO_SIDED|95.0|-8.32|1.52|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.52|-8.32|0.174
91621052|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-6.86|STANDARD_ERROR_OF_MEAN|4.19||0.104|TWO_SIDED|95.0|-15.13|1.41|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||1.41|-15.13|0.104
91621053|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-8.64|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.09|-0.19|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-0.19|-17.09|0.045
91621054|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|3.9||0.002|TWO_SIDED|95.0|-19.97|-4.59|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-4.59|-19.97|0.002
91621055|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-8.66|STANDARD_ERROR_OF_MEAN|4.67||0.066|TWO_SIDED|95.0|-17.89|0.57|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||0.57|-17.89|0.066
91621056|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|4.76||0.175|TWO_SIDED|95.0|-15.89|2.91|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.91|-15.89|0.175
91621057|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-11.28|STANDARD_ERROR_OF_MEAN|4.34||0.01|TWO_SIDED|95.0|-19.84|-2.72|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||-2.72|-19.84|0.010
91621058|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-7.31|STANDARD_ERROR_OF_MEAN|3.36||0.03|TWO_SIDED|95.0|-13.93|-0.7|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-0.70|-13.93|0.030
91621059|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|3.31||0.122|TWO_SIDED|95.0|-11.65|1.39|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||1.39|-11.65|0.122
91621060|NCT03334396|183135175|SUPERIORITY||Mean Difference (Final Values)|-16.52|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-22.64|-10.41|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-10.41|-22.64|<0.001
91659970|NCT02242201|183214650|SUPERIORITY|||||||0.216|||||||Regression, Cox|||Baseline vs 3 months||||0.216
91621061|NCT03334396|183135176|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.061|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.061
91621062|NCT03334396|183135176|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.06|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.060
91621063|NCT03334396|183135176|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.12|0.04|<0.001
91659971|NCT02242201|183214650|SUPERIORITY|||||||0.968|||||||Regression, Cox|||Baseline vs 3 months||||0.968
91659972|NCT02242201|183214651|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Pain at rest||||0.776
91659973|NCT02242201|183214651|SUPERIORITY|||||||0.447|||||||Kruskal-Wallis|||Pain with movement||||0.447
91621064|NCT03334396|183135176|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.046|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|0.00|0.046
91621065|NCT03334396|183135176|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.059|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|-0.00|0.059
91621066|NCT03334396|183135176|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.06|0.16|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.16|0.06|<0.001
91621067|NCT03334396|183135177|SUPERIORITY||Mean Difference (Final Values)|2.97|STANDARD_ERROR_OF_MEAN|3.21||0.356|TWO_SIDED|95.0|-3.36|9.3|||Mixed Models Analysis|||EQ-5D-5L VAS Score||9.30|-3.36|0.356
91621068|NCT03334396|183135177|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|3.13||0.668|TWO_SIDED|95.0|-4.81|7.5|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.50|-4.81|0.668
91621069|NCT03334396|183135177|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_ERROR_OF_MEAN|2.95||0.017|TWO_SIDED|95.0|1.25|12.86|||Mixed Models Analysis|||EQ-5D-5L VAS Score||12.86|1.25|0.017
91621070|NCT03334396|183135178|SUPERIORITY||Odds Ratio (OR)|1.38||||0.603|TWO_SIDED|95.0|0.41|4.71|||Regression, Logistic|||||4.71|0.41|0.603
91621071|NCT03334396|183135178|SUPERIORITY||Odds Ratio (OR)|4.08||||0.006|TWO_SIDED|95.0|1.5|11.12|||Regression, Logistic|||||11.12|1.50|0.006
91621072|NCT03334396|183135178|SUPERIORITY||Odds Ratio (OR)|4.72||||0.002|TWO_SIDED|95.0|1.78|12.55|||Regression, Logistic|||||12.55|1.78|0.002
91621073|NCT00592553|183135210|OTHER||Least Square (LS) Mean Difference|-30.52|STANDARD_ERROR_OF_MEAN|42.68||0.4756|TWO_SIDED|95.0|-114.8|53.75|||Mixed Models Analysis|||Analysis was performed using mixed model for repeated measures (MMRM) method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||53.75|-114.8|0.4756
91659974|NCT02242201|183214652|SUPERIORITY|||||||0.986|||||||ANOVA|||||||0.986
91659975|NCT02242201|183214652|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
91621074|NCT00592553|183135210|OTHER||LS Mean Difference|62.65|STANDARD_ERROR_OF_MEAN|43.21||0.149|TWO_SIDED|95.0|-22.66|147.96|||Mixed Models Analysis|||Analysis was performed using MMRM method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (\< 9 years vs. \>= 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||147.96|-22.66|0.1490
91621075|NCT03829332|183135233|OTHER||Hazard Ratio (HR)|0.78||||0.00624|TWO_SIDED|95.0|0.64|0.95|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||Hazards ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||0.95|0.64|0.00624
91621076|NCT03829332|183135234|OTHER||Hazard Ratio (HR)|1.1||||0.79744|TWO_SIDED|95.0|0.87|1.39|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region, and baseline PD-L1 status.||HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||1.39|0.87|0.79744
91621077|NCT03829332|183135235|OTHER||Percent Difference|12.8||||0.00037|TWO_SIDED|95.0|5.4|20.1|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Percent difference and 95% CI were calculated using Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||20.1|5.4|0.00037
91621078|NCT03829332|183135238|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-3.9||||0.0262|TWO_SIDED|95.0|-7.34|-0.47|||Constrained longitudinal data analysis|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||-0.47|-7.34|0.0262
91621079|NCT03829332|183135239|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-4.5||||0.0461|TWO_SIDED|95.0|-8.91|-0.08||Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.|cLDA model|||||-0.08|-8.91|0.0461
91621080|NCT03829332|183135240|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-1.1||||0.5596|TWO_SIDED|95.0|-4.78|2.59|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||2.59|-4.78|0.5596
91621081|NCT03829332|183135241|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-0.88||||0.7088|TWO_SIDED|95.0|-5.49|3.74|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||3.74|-5.49|0.7088
91621082|NCT03829332|183135242|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-3.01||||0.1116|TWO_SIDED|95.0|-6.71|0.7|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||0.70|-6.71|0.1116
91621083|NCT03829332|183135243|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.0||||0.9601|TWO_SIDED|95.0|0.75|1.33|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.33|0.75|0.9601
91659976|NCT02242201|183214652|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
91659977|NCT02242201|183214652|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
91659978|NCT02242201|183214653|SUPERIORITY|||||||0.898|||||||ANOVA|||||||0.898
91659979|NCT02242201|183214653|SUPERIORITY|||||||0.112|||||||t-test, 1 sided|||Baseline vs 3 months||||0.112
91659980|NCT02242201|183214653|SUPERIORITY|||||||0.046|||||||t-test, 1 sided|||Baseline vs 3 months||||0.046
91659981|NCT02242201|183214653|SUPERIORITY|||||||0.026|||||||t-test, 1 sided|||Baseline vs 3 months||||0.026
91659982|NCT02242201|183214654|SUPERIORITY|||||||0.843|||||||Fisher Exact|||Operative extremity neurologic changes||||0.843
91659983|NCT02242201|183214654|SUPERIORITY|||||||1|||||||Fisher Exact|||Wound infection||||1.00
91659984|NCT02242201|183214654|SUPERIORITY|||||||1|||||||Fisher Exact|||Fall requiring medical attention||||1.00
91659985|NCT02242201|183214655|SUPERIORITY|||||||1|||||||Fisher Exact|||Pain at rest||||1.00
91659986|NCT02242201|183214655|SUPERIORITY|||||||0.167|||||||Fisher Exact|||Pain with movement||||0.167
91659987|NCT01379664|183214667|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.06||||0.24|TWO_SIDED|95.0|0.97|1.16|||Wilcoxon (Mann-Whitney)|||||1.16|0.97|0.24
91659988|NCT01379664|183214668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.87|TWO_SIDED|95.0|-0.23|0.19|||Generalized estimating equation model|Generalized estimating equation model weighted by inverse propensity score||||0.19|-0.23|0.87
91659989|NCT01379664|183214669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.74|TWO_SIDED|95.0|-4.7|3.3|||Generalized estimating equation model|Generalized estimating equation model weighted by propensity score||||3.3|-4.7|0.74
91659990|NCT02298322|183214671|OTHER||sucess proportion|91.4|||<|0.0001|TWO_SIDED|95.0|86.2|95.1|||t-test, 1 sided|||||95.1|86.2|<0.0001
91659991|NCT03880266|183214683|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.244|TWO_SIDED|95.0|-3.76|0.6|||Wilcoxon (Mann-Whitney)|||||0.60|-3.76|0.244
91659992|NCT03880266|183214683|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.168|TWO_SIDED|95.0|-0.65|3.43|||Wilcoxon (Mann-Whitney)|||||3.43|-0.65|0.168
91659993|NCT03880266|183214683|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.699|TWO_SIDED|95.0|-2.39|1.72|||Wilcoxon (Mann-Whitney)|||||1.72|-2.39|0.699
91659994|NCT03880266|183214683|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.833|TWO_SIDED|95.0|-1.94|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-1.94|0.833
91659995|NCT03880266|183214684|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91659996|NCT03880266|183214684|SUPERIORITY|||||||0.589|||||||Fisher Exact|||||||0.589
91659997|NCT03880266|183214684|SUPERIORITY|||||||0.154|||||||Fisher Exact|||||||0.154
91659998|NCT03880266|183214684|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
91659999|NCT03880266|183214685|SUPERIORITY||Mean Difference (Final Values)|-206.5||||0.093|TWO_SIDED|95.0|-451.9|38.9|||t-test, 2 sided|||||38.9|-451.9|0.093
91660000|NCT03880266|183214685|SUPERIORITY||Mean Difference (Final Values)|144.1||||0.186|TWO_SIDED|95.0|-78.6|366.7|||t-test, 2 sided|||||366.7|-78.6|0.186
91660001|NCT03880266|183214685|SUPERIORITY||Mean Difference (Final Values)|-151.7||||0.058|TWO_SIDED|95.0|-309.0|5.7|||t-test, 2 sided|||||5.7|-309.0|0.058
91660002|NCT03880266|183214685|SUPERIORITY||Mean Difference (Final Values)|160.6||||0.186|TWO_SIDED|95.0|-611.2|290.1|||t-test, 2 sided|||||290.1|-611.2|0.186
91660003|NCT03880266|183214686|SUPERIORITY||Mean Difference (Final Values)|-33.62||||0.13|TWO_SIDED|95.0|-78.42|11.17|||t-test, 2 sided|||||11.17|-78.42|0.130
91660004|NCT03880266|183214686|SUPERIORITY||Mean Difference (Final Values)|24.26||||0.518|TWO_SIDED|95.0|-54.62|103.13|||t-test, 2 sided|||||103.13|-54.62|0.518
91660005|NCT03880266|183214686|SUPERIORITY||Mean Difference (Final Values)|-38.14||||0.061|TWO_SIDED|95.0|-78.32|2.03|||t-test, 2 sided|||||2.03|-78.32|0.061
91660006|NCT03880266|183214686|SUPERIORITY||Mean Difference (Final Values)|-39.34||||0.366|TWO_SIDED|95.0|-128.4|49.72|||t-test, 2 sided|||||49.72|-128.40|0.366
91660007|NCT03880266|183214687|SUPERIORITY|||||||0.515|||||||Fisher Exact|||||||0.515
91660008|NCT03880266|183214687|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.560
91660009|NCT03880266|183214687|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
91660010|NCT03880266|183214687|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.290
91660011|NCT05472038|183214715|SUPERIORITY|Superiority based on GMR was declared if the lower limit of the 2-sided 95% CI for the GMR was greater than 1.|Model-Based GMR|2.91|||||TWO_SIDED|95.0|2.45|3.44||||||||3.44|2.45|
91660012|NCT05472038|183214716|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-5%.|Adjusted Difference in Percentages|26.77|||||TWO_SIDED|95.0|19.59|33.95|||||Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (\< median,\>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.|||33.95|19.59|
91660013|NCT05472038|183214717|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.16|0.83|
91660014|NCT05472038|183214718|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-10%.|Adjusted Difference in Percentages|-3.03|||||TWO_SIDED|95.0|-9.68|3.63|||||2-Sided CI based on Miettinen and Nurminen method stratified by baseline NT category(\< median,\>= median)for difference in percentage(seroresponse rate).Median of baseline neutralizing titers was calculated based on pooled data in 2 comparator groups.|||3.63|-9.68|
91621084|NCT03829332|183135244|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|0.61||||0.0079|TWO_SIDED|95.0|0.42|0.88|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||0.88|0.42|0.0079
91621085|NCT03829332|183135245|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.06||||0.7457|TWO_SIDED|95.0|0.73|1.56|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.56|0.73|0.7457
91621086|NCT03829332|183135246|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.04||||0.8122|TWO_SIDED|95.0|0.75|1.44|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.44|0.75|0.8122
91621087|NCT03829332|183135247|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.24||||0.148|TWO_SIDED|95.0|0.92|1.67|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.67|0.92|0.1480
91621088|NCT03829332|183135248|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||2.46|0.70|0.4068
91621089|NCT01283997|183135249|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.54|TWO_SIDED|95.0|-0.13|0.24|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the fingertip||0.24|-0.13|0.54
91621090|NCT01283997|183135249|OTHER||Mean Difference (Final Values)|0.05||||0.6|TWO_SIDED|95.0|-0.13|0.23|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the palm||0.23|-0.13|0.60
91621091|NCT01283997|183135249|OTHER||Mean Difference (Final Values)|-0.12||||0.37|TWO_SIDED|95.0|-0.4|0.15|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the forearm||0.15|-0.40|0.37
91621092|NCT01283997|183135250|OTHER||Mean Difference (Final Values)|-0.73||||0.56|TWO_SIDED|95.0|-2.06|0.59|||Wilcoxon (Mann-Whitney)|||Difference in Numbness severity at baseline and week 10.||0.59|-2.06|0.56
91621093|NCT00884221|183135277|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, ITT|2.2||||0.499|TWO_SIDED|95.0|-4.2|8.6||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin-recombinant FSH, ITT analysis set|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||8.6|-4.2|0.499
91621094|NCT00884221|183135278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Estradiol||||<0.001
91660015|NCT05472038|183214723|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.56|1.22|
91713412|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 4.|Wilcoxon test|||||||0.16
91621095|NCT00884221|183135279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||FSH||||<0.001
91621096|NCT00884221|183135280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Free Androgen Index||||<0.001
91621097|NCT00884221|183135281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Luteinizing hormone||||<0.001
91660016|NCT03785548|183214740|OTHER||Mean Difference (Final Values)|2.851|STANDARD_ERROR_OF_MEAN|2.576||0.27|TWO_SIDED|95.0|-2.241|7.944|||ANCOVA|F(1, 140)=1.225||||7.944|-2.241|0.270
91660017|NCT03785548|183214741|OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.098||0.964|TWO_SIDED|95.0|-5.983|6.266|||ANCOVA|F(1, 140)=0.002||||6.266|-5.983|0.964
91621098|NCT00884221|183135282|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Progesterone||||0.630
91621099|NCT00884221|183135283|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, PP|3.0||||0.387|TWO_SIDED|95.0|-3.8|9.8||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin - recombinant FSH, PP|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||9.8|-3.8|0.387
91621100|NCT00884221|183135284|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Prolactin||||0.047
91621101|NCT00884221|183135285|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Sex hormone binding globulin||||0.009
91621102|NCT00884221|183135286|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Testosterone||||<0.001
91621103|NCT00884221|183135287|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>= 12 mm on the last stimulation day||||0.025
91621104|NCT00884221|183135287|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 12-14 mm on the last stimulation day||||0.024
91621105|NCT00884221|183135287|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 15-16 mm on the last stimulation day||||0.728
91621106|NCT00884221|183135287|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>=17 mm on the last stimulation day||||0.285
91621107|NCT00884221|183135288|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who underwent the oocyte retrieval procedure were included in the analysis||Treatments were compared using the Wilcoxon test for the average number of oocytes retrieved.||||<0.001
91621108|NCT00884221|183135289|SUPERIORITY_OR_OTHER|||||||0.969||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who had oocytes retrieved were included in the analysis.||||||0.969
91621109|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 1 / 2pn||||0.406
91621110|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.232||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 2 / 2pn||||0.232
91621111|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 3 / 2pn||||0.412
91621112|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 4 / 2pn||||0.438
91621113|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 5 / 2pn||||0.390
91621114|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.958||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 4AA / 2pn||||0.958
91621115|NCT00884221|183135290|SUPERIORITY_OR_OTHER|||||||0.954||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 5AA / 2pn||||0.954
91621116|NCT00884221|183135291|SUPERIORITY_OR_OTHER||Comparison of distributions|0.398||||0.398|TWO_SIDED|95.0|-3.6|9.1|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.1|-3.6|0.398
91621117|NCT00884221|183135292|SUPERIORITY_OR_OTHER||Comparison of distributions|1.8||||0.686|TWO_SIDED|95.0|-5.6|9.2|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in cumulative live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.2|-5.6|0.686
91621118|NCT01263093|183135295|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.77|||||TWO_SIDED|90.0|0.72|0.83|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.83|0.72|
91621119|NCT01263093|183135296|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.59|||||TWO_SIDED|90.0|0.53|0.67|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.67|0.53|
91524879|NCT05375955|182925300|OTHER||Risk Difference (RD)|12.4||||0.0711|TWO_SIDED|95.0|-4.1|29.4|||Chan and Zhang (1999) method|||||29.4|-4.1|0.0711
91621120|NCT01263093|183135298|SUPERIORITY_OR_OTHER||Median of Paired Differences|0.0||||0.3303|TWO_SIDED|90.0|0.0|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|0.00|0.3303
91660018|NCT01993030|183214742|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Growth of Granulation Tissue between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with healthy granulation tissue and the Participants with unhealthy granulation tissue category."||||0.49
91621121|NCT04857593|183135363|OTHER||Mean change in EPDS score|5.4||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
91621122|NCT02475850|183135409|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.245|TWO_SIDED|95.0|0.8|1.06||p\<0.05 threshold (primary outcome)|Regression, Cox|multistate model accounting for death as a semi-competing risk||||1.06|0.80|0.245
91621123|NCT02475850|183135410|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.004|TWO_SIDED|99.0|0.83|0.99||p\< 0.01 threshold (secondary outcome)|Regression, Cox|||||0.99|0.83|0.004
91621124|NCT02475850|183135412|SUPERIORITY||Difference in least-squared means across|0.72|STANDARD_ERROR_OF_MEAN|0.71||0.309|TWO_SIDED|99.0|-1.1|2.54||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||2.54|-1.10|0.309
91621125|NCT02475850|183135413|SUPERIORITY||Least squares means|0.59||||0.528|TWO_SIDED|99.0|-1.8|0.93||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||0.93|-1.80|0.528
91621126|NCT02475850|183135414|SUPERIORITY||Least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.43||0.037|TWO_SIDED|99.0|-2.0|0.2||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)|||0.20|-2.00|0.037
91621127|NCT02475850|183135415|SUPERIORITY||Least squares means|-1.19|STANDARD_ERROR_OF_MEAN|0.45||0.009|TWO_SIDED|99.0|-2.36|-0.02||p\<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||-0.02|-2.36|0.009
91621128|NCT02475850|183135416|SUPERIORITY||Least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.51||0.897|TWO_SIDED|99.0|-1.38|1.25||p \<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)|||1.25|-1.38|0.897
91621129|NCT01494987|183135459|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is from a mixed-effect model including terms for baseline HbA1c value, prior antihyperglycemia therapy, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.32|-0.71|<0.001
91621130|NCT00205699|183135506|SUPERIORITY||||||<|0.0001||||||The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.0001
91621131|NCT00205699|183135507|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
91621132|NCT00205699|183135508|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
91621133|NCT00205699|183135509|SUPERIORITY|||||||0.17|||||||ANCOVA|||||||0.17
91621134|NCT00205699|183135510|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
91621135|NCT00205699|183135511|SUPERIORITY||||||<|0.003|||||||ANCOVA|||Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.003
91722446|NCT04044690|183337605|SUPERIORITY||Odds Ratio (OR)|1.2||||0.335347|TWO_SIDED|95.0|0.52|2.766||Descriptive p-value.|Regression, Logistic|Exact logistic regression model including fixed effects for treatment, region (Japan vs. non-Japan) and Baseline MMT-8 (≤ 142 points vs. \>142 points).|Rubin's rule for combination applied following MI.|||2.766|0.520|0.335347
91621136|NCT00205699|183135511|SUPERIORITY|||||||0.003||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|Contrast|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.003
91621137|NCT00205699|183135511|SUPERIORITY|||||||0.002||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|ANCOVA|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.002
91621138|NCT02928380|183135529|OTHER||Least square (LS) mean difference|-0.02||||0.0987|TWO_SIDED|95.0|-0.05|0.0|||ANOVA|ANOVA Model with weight of the peanut particle (food occlusion) as response variable, treatment and period as fixed effect.|Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.|H0: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is no different from using no adhesive H01: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is different from using no adhesive.||0.00|-0.05|0.0987
91621139|NCT01677507|183135547|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.4|3.3|||t-test, 2 sided|Actually these are 2 sided paired t-tests.||Right Eye treated vs. untreated||3.3|2.4|0.0001
91621140|NCT01677507|183135547|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.5|3.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye treated vs. untreated||3.2|2.5|0.0001
91621141|NCT01677507|183135547|OTHER||Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|2.5|3.4|||t-test, 2 sided|paired t-test, 2 sided||Right Eye treated vs. untreated||3.4|2.5|0.0001
91621142|NCT01677507|183135547|OTHER||Mean Difference (Final Values)|2.9||||0.0001|TWO_SIDED|95.0|2.5|3.3|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||3.3|2.5|0.0001
91621143|NCT01677507|183135548|OTHER||Median Difference (Final Values)|1.1||||0.0001|TWO_SIDED|95.0|0.9|1.3|||t-test, 2 sided|paired t test, 2 sided||Right Eye treated to untreated||1.3|0.9|0.0001
91621144|NCT01677507|183135548|OTHER||Median Difference (Final Values)|0.9||||0.0001|TWO_SIDED|95.0|0.7|1.1|||t-test, 2 sided|paired t test, 2 sided||Left Eye, treated vs. untreated||1.1|0.7|0.0001
91621145|NCT01677507|183135548|OTHER||Mean Difference (Final Values)|0.01||||0.94|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|paired t-test||Right Eye, treated vs. untreated||0.2|-0.2|0.94
91621146|NCT01677507|183135548|OTHER||Mean Difference (Final Values)|0.05||||0.54|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.2|-0.1|0.54
91621147|NCT01677507|183135549|OTHER||Mean Difference (Final Values)|0.4||||0.04|TWO_SIDED|95.0|0.01|0.7|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.7|0.01|0.04
91621148|NCT01677507|183135549|OTHER||Mean Difference (Final Values)|0.2||||0.15|TWO_SIDED|95.0|-0.1|0.6|||t-test, 2 sided|paired t-test, 2 sided||Left eye, treated vs. untreated||0.6|-0.1|0.15
91621149|NCT01677507|183135549|OTHER||Mean Difference (Final Values)|0.1||||0.52|TWO_SIDED|95.0|-0.3|0.6|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.6|-0.3|0.52
91621150|NCT01677507|183135549|OTHER||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.4|-0.4|0.88
91621151|NCT00961441|183135552|SUPERIORITY_OR_OTHER||Point estimate for ratio|1.0271|||||TWO_SIDED|90.0|0.8817|1.1964|||ANOVA|Point estimates for the geometric means ratios children/adults for Cmax normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.1964|0.8817|
91524880|NCT05375955|182925300|OTHER||Risk Difference (RD)|10.1||||0.129|TWO_SIDED|95.0|-6.1|26.8|||Chan and Zhang (1999) method|||||26.8|-6.1|0.1290
91621152|NCT00961441|183135553|SUPERIORITY_OR_OTHER||Point estimate for ratio|0.9914|||||TWO_SIDED|90.0|0.811|1.2118|||ANOVA|Point estimates for the geometric means ratios children/adults for AUCtau normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.2118|0.8110|
91621153|NCT01586156|183135557|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91621154|NCT01586156|183135558|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91621155|NCT01586156|183135559|OTHER|Pearson's correlation test of association of alprenolol binding changes to dose carvedilol.||||||0.02||||||Correlation of the change in alprenolol binding relative to dose carvedilol.|Pearson|||||||0.02
91621156|NCT01586156|183135560|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
91621157|NCT01586156|183135562|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91621158|NCT01586156|183135563|NON_INFERIORITY|Carvedilol did not lead to worse cardiac output as compared to placebo.||||||0.8|||||||ANOVA|||||||0.8
91621159|NCT04465396|183135564|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.22|||||TWO_SIDED|90.0|104.83|113.8|||||The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.|||113.80|104.83|
91621160|NCT04465396|183135564|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|113.99|||||TWO_SIDED|90.0|108.32|119.95|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||119.95|108.32|
91621161|NCT04465396|183135565|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|98.27|||||TWO_SIDED|90.0|88.5|109.11|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||109.11|88.50|
91722447|NCT01932606|183337700|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
91524881|NCT05375955|182925301|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||||24.3|-10.8|0.2712
91524882|NCT05375955|182925301|OTHER||Risk Difference (RD)|28.3||||0.0028|TWO_SIDED|95.0|7.7|47.5|||Chan and Zhang (1999) method|||||47.5|7.7|0.0028
91524883|NCT05375955|182925301|OTHER||Risk Difference (RD)|36.6||||0.0003|TWO_SIDED|95.0|14.7|56.4|||Chan and Zhang (1999) method|||||56.4|14.7|0.0003
91524884|NCT05375955|182925302|OTHER||Risk Difference (RD)|0.1||||0.5701|TWO_SIDED|95.0|-10.2|10.7|||Chan and Zhang (1999) method|||Week 1||10.7|-10.2|0.5701
91621162|NCT04465396|183135565|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|92.48|||||TWO_SIDED|90.0|83.8|102.05|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||102.05|83.80|
91621163|NCT04465396|183135566|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.44|||||TWO_SIDED|90.0|105.51|113.51|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||113.51|105.51|
91621164|NCT04465396|183135566|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|118.4|||||TWO_SIDED|90.0|112.31|124.83|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||124.83|112.31|
91621165|NCT03011450|183135681|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621166|NCT03011450|183135682|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621167|NCT03011450|183135683|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621168|NCT03011450|183135684|SUPERIORITY|||||||0.0156|||||||Hodges-Lehmann method|||||||0.0156
91621169|NCT03011450|183135685|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91660019|NCT01993030|183214743|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Inflammatory Reaction between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with Inflammatory Reaction and the Participants without Inflammatory Reaction category."||||0.36
91621170|NCT03011450|183135686|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621171|NCT03011450|183135687|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621172|NCT03011450|183135688|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
91621173|NCT03011450|183135689|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91722448|NCT01932606|183337701|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure.||||0.0003
91621174|NCT03011450|183135690|SUPERIORITY|||||||0.538|||||||Hodges-Lehmann method|||||||0.5380
91621175|NCT03011450|183135691|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621176|NCT03011450|183135692|SUPERIORITY|||||||0.1165|||||||Hodges-Lehmann method|||||||0.1165
91621177|NCT03011450|183135693|SUPERIORITY|||||||0.0142|||||||Hodges-Lehmann method|||||||0.0142
91621178|NCT03011450|183135694|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621179|NCT03011450|183135695|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621180|NCT03011450|183135696|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621181|NCT03011450|183135697|SUPERIORITY|||||||0.4589|||||||Hodges-Lehmann method|||||||0.4589
91621182|NCT03011450|183135698|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621183|NCT03011450|183135699|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621184|NCT03011450|183135700|OTHER||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621185|NCT03011450|183135701|SUPERIORITY|||||||0.2486|||||||Hodges-Lehmann method|||||||0.2486
91621186|NCT03011450|183135702|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621187|NCT03011450|183135703|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621188|NCT03011450|183135704|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621189|NCT03011450|183135705|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621190|NCT03011450|183135706|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
91621191|NCT03011450|183135707|SUPERIORITY|||||||0.2763|||||||Hodges-Lehmann method|||||||0.2763
91621192|NCT03011450|183135708|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621193|NCT03011450|183135709|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621194|NCT03011450|183135710|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621195|NCT03011450|183135711|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621196|NCT03011450|183135712|SUPERIORITY|||||||0.1651|||||||Hodges-Lehmann method|||||||0.1651
91621197|NCT03011450|183135713|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621198|NCT03011450|183135714|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621199|NCT03011450|183135715|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621200|NCT03011450|183135716|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621201|NCT03011450|183135717|SUPERIORITY|||||||0.5107|||||||Hodges-Lehmann method|||||||0.5107
91621202|NCT03011450|183135718|SUPERIORITY||Hodges-Lehmann method|||||0.0018|||||||Hodges-Lehmann method|||||||0.0018
91621203|NCT03011450|183135719|SUPERIORITY|||||||0.0742|||||||Hodges-Lehmann method|||||||0.0742
91621204|NCT03011450|183135720|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621205|NCT03011450|183135721|SUPERIORITY|||||||0.2707|||||||Hodges-Lehmann method|||||||0.2707
91621206|NCT03011450|183135722|SUPERIORITY|||||||0.0009|||||||Hodges-Lehmann method|||||||0.0009
91621207|NCT03011450|183135723|SUPERIORITY|||||||0.2879|||||||Hodges-Lehmann method|||||||0.2879
91621208|NCT03011450|183135724|SUPERIORITY|||||||0.9786|||||||Hodges-Lehmann method|||||||0.9786
91621209|NCT03011450|183135725|SUPERIORITY|||||||0.0075|||||||Hodges-Lehmann method|||||||0.0075
91621210|NCT03011450|183135726|SUPERIORITY|||||||0.0241|||||||Hodges-Lehmann method|||||||0.0241
91660020|NCT01993030|183214744|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the VAS score between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.11
91621211|NCT03011450|183135727|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621212|NCT03011450|183135728|SUPERIORITY|||||||0.0502|||||||Hodges-Lehmann method|||||||0.0502
91621213|NCT03011450|183135729|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621214|NCT03011450|183135730|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
91621215|NCT03011450|183135731|SUPERIORITY|||||||0.0209|||||||Hodges-Lehmann method|||||||0.0209
91621216|NCT03011450|183135732|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621217|NCT03011450|183135733|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621218|NCT03011450|183135734|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621219|NCT03011450|183135735|SUPERIORITY||||||<|0.0001|||||||non-parametric Hodges-Lehmann method|||||||<0.0001
91621220|NCT03011450|183135736|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
91621221|NCT03011450|183135737|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
91621222|NCT03519516|183135795|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.749|||||||Wilcoxon (Mann-Whitney)|||||||0.749
91524885|NCT05375955|182925302|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
91621223|NCT03519516|183135796|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.041|||||||Chi-squared|||||||0.041
91621224|NCT03519516|183135797|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
91621225|NCT03519516|183135798|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.495|||||||Wilcoxon (Mann-Whitney)|||||||0.495
91621226|NCT03519516|183135799|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.492||||||statistical analysis between groups for final visit with green lissamine|Chi-squared|||||||0.492
91621227|NCT03519516|183135799|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.238||||||statistical analysis between groups for final visit with fluorescein|Chi-squared, Corrected|||||||0.238
91621228|NCT03519516|183135800|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.213|||||||Chi-squared|||||||0.213
91621229|NCT03519516|183135802|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.741|||||||Chi-squared, Corrected|||||||0.741
91621230|NCT03519516|183135804|NON_INFERIORITY|The study drug is considered non-inferior with respect to the comparator if there are no differences above twenty percent||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
91621231|NCT01244191|183135811|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8086|TWO_SIDED|95.0|0.841|1.149|||Log Rank||Hazard ratio and the 95% confidence interval from stratified Cox-regression model (adjusting for number of prior therapies, gender, and smoking history).|||1.149|0.841|0.8086
91621232|NCT01752842|183135819|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-0.75||||0.07|TWO_SIDED|95.0|-1.56|0.04||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of cardiac diastolic function adjusting for body fat percent, baseline values of BMI, diastolic/systolic blood pressure, HbA1c, fasting glucose, triglycerides, ethnicity, gender and race.|Null hypothesis is no difference of mean change of cardiac diastolic function as measured by E' (cm/s) between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.04|-1.56|0.07
91621233|NCT01752842|183135820|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|0.0058||||0.8128|TWO_SIDED|95.0|-0.0418|0.0543||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.|Null hypothesis is no difference of mean change of fractional shortening percent between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.0543|-0.0418|0.8128
91621234|NCT01752842|183135821|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-1.79||||0.0034|TWO_SIDED|95.0|-2.93|-0.65||This P-value is based on ANCOVA.|ANCOVA|ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.||Null hypothesis is no difference of mean change of C24:0/C16:0 ceramide ratio between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|-0.65|-2.93|0.0034
91722449|NCT01932606|183337701|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure.||||0.01
91621235|NCT02164513|183135822|SUPERIORITY||Rate ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.7|0.81||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.81|0.70|<0.001
91621236|NCT02164513|183135822|SUPERIORITY||Rate ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.9||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.90|0.80|<0.001
91621237|NCT02164513|183135823|SUPERIORITY||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.0061|<|0.001|TWO_SIDED|95.0|0.085|0.109||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI versus (vs) FF/VI at Week 52.|Mixed Models Repeated Measures|||||0.109|0.085|<0.001
91621238|NCT02164513|183135824|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.4|-1.1||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI vs FF/VI at Week 52.|Mixed Models Repeated Measures|||||-1.1|-2.4|<0.001
91621239|NCT02164513|183135825|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Cox proportional hazard model|||||0.91|0.80|<0.001
91524886|NCT05375955|182925302|OTHER||Risk Difference (RD)|9.6||||0.0532|TWO_SIDED|95.0|-2.0|23.7|||Chan and Zhang (1999) method|||Week 2||23.7|-2.0|0.0532
91621240|NCT02164513|183135825|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Cox proportional hazard model|||||0.91|0.78|<0.001
91621241|NCT02164513|183135826|SUPERIORITY||Rate ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.62|0.75|||Negative binomial Model|||||0.75|0.62|<0.001
91621242|NCT02164513|183135827|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.85|||Cox proportional hazard model|||||0.85|0.70|<0.001
91621243|NCT02164513|183135828|SUPERIORITY||Rate Ratio|0.87||||0.064|TWO_SIDED|95.0|0.76|1.01|||Negative binomial model|||||1.01|0.76|0.064
91621244|NCT02164513|183135828|SUPERIORITY||Rate ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.56|0.78|||Negative binomial model|||||0.78|0.56|<0.001
91660021|NCT01993030|183214745|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Exudation between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to No exudation and Little exudation category."||||0.11
91524887|NCT05375955|182925302|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
91621245|NCT05301322|183135835|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.86|||||TWO_SIDED|95.0|0.785|0.951|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV A||0.951|0.785|
91621246|NCT05301322|183135835|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.85|||||TWO_SIDED|95.0|0.766|0.943|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV B||0.943|0.766|
91621247|NCT05301322|183135836|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.86|||||TWO_SIDED|95.0|0.769|0.963|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H1N1 A/Victoria||0.963|0.769|
91713413|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0457||||||The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0457
91713414|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 1.|Wilcoxon test|||||||0.63
91524888|NCT05375955|182925302|OTHER||Risk Difference (RD)|0.5||||0.5123|TWO_SIDED|95.0|-14.4|15.7|||Chan and Zhang (1999) method|||Week 4||15.7|-14.4|0.5123
91621248|NCT05301322|183135836|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.77|||||TWO_SIDED|95.0|0.68|0.866|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H3N2 A/Darwin||0.866|0.680|
91621249|NCT05301322|183135836|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.9|||||TWO_SIDED|95.0|0.789|1.019|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Austria||1.019|0.789|
91621250|NCT05301322|183135836|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.87|||||TWO_SIDED|95.0|0.779|0.964|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Phuket||0.964|0.779|
91621251|NCT04971785|183135841|SUPERIORITY||Difference in percentages|5.7||||0.2289|TWO_SIDED|95.0|-3.6|14.9|||Stratified Mantel-Haenszel test||Percentage difference and 95% confidence interval (CI) between each pair of treatment groups were from stratified Mantel-Haenszel test with baseline diabetes status and baseline enhanced liver fibrosis (ELF) category as stratification factors.|||14.9|-3.6|0.2289
91621252|NCT04971785|183135842|SUPERIORITY||Difference in percentages|-1.8||||0.6959|TWO_SIDED|95.0|-11.1|7.4|||Stratified Mantel-Haenszel test||Percentage difference and 95% CI between each pair of treatment groups presented were from stratified Mantel-Haenszel test with baseline diabetes status and baseline ELF category as stratification factors.|||7.4|-11.1|0.6959
91524889|NCT05375955|182925302|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
91524890|NCT05375955|182925302|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 6||24.8|-8.9|0.2736
91524891|NCT05375955|182925302|OTHER||Risk Difference (RD)|3.0||||0.3967|TWO_SIDED|95.0|-13.0|19.8|||Chan and Zhang (1999) method|||Week 6||19.8|-13.0|0.3967
91621253|NCT04971785|183135843|SUPERIORITY||Difference in percentages|35.7|||<|0.0001|TWO_SIDED|95.0|18.8|52.6|||Stratified Mantel-Haenszel test||Percentage difference and 95% CI between each pair of treatment groups presented are from stratified Mantel-Haenszel test with baseline diabetes status and baseline ELF category as stratification factors.|||52.6|18.8|<0.0001
91621254|NCT04971785|183135844|SUPERIORITY||Difference in percentages|26.1||||0.0006|TWO_SIDED|95.0|11.3|40.9|||Stratified Mantel-Haenszel test||Percentage difference and 95% CI between each pair of treatment groups presented were from stratified Mantel-Haenszel test with baseline diabetes status and baseline ELF category as stratification factors.|||40.9|11.3|0.0006
91621255|NCT05458011|183135849|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||||-0.95|-2.66|<0.0001
91621256|NCT03292952|183135867|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91621257|NCT04656418|183135880|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
91621258|NCT04656418|183135881|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
91621259|NCT04656418|183135882|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
91621260|NCT04656418|183135882|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
91621261|NCT04656418|183135882|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
91621262|NCT04656418|183135883|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
91621263|NCT04656418|183135883|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
91621264|NCT04656418|183135883|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
91621265|NCT04656418|183135884|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
91621266|NCT04656418|183135884|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
91621267|NCT04656418|183135885|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical testing H02) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
91621268|NCT02667457|183135909|OTHER|||||||0.0095||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0095
91621269|NCT02667457|183135909|OTHER|||||||0.0029||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0029
91621270|NCT02667457|183135910|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
91621271|NCT02667457|183135910|OTHER|||||||0.0334||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0334
91713415|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.55||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 3.|Wilcoxon test|||||||0.55
91621272|NCT02667457|183135911|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
91621273|NCT02667457|183135911|OTHER|||||||0.0301||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0301
91524892|NCT05375955|182925302|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 8||20.2|-13.6|0.3997
91621274|NCT02667457|183135912|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
91621275|NCT02667457|183135912|OTHER|||||||0.0387||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0387
91621276|NCT02667457|183135913|OTHER|||||||0.0359||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0359
91621277|NCT02667457|183135913|OTHER|||||||0.0022||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0022
91621278|NCT03097614|183135921|SUPERIORITY|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
91621279|NCT00680953|183135922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.343||||0.0001|TWO_SIDED|95.0|0.194|0.606|||Log Rank|||||0.606|0.194|0.0001
91621280|NCT00680953|183135923|SUPERIORITY_OR_OTHER|||||||0.9951|||||||Log Rank|||||||0.9951
91621281|NCT00680953|183135924|SUPERIORITY_OR_OTHER|||||||0.1568|||||||Log Rank|||||||0.1568
91621282|NCT02700919|183135928|SUPERIORITY|||||||0.012|||||||Log Rank|||Change from Baseline on Day 7||||0.012
91621283|NCT02700919|183135928|SUPERIORITY||||||<|0.001|||||||Log Rank|||Change from Baseline on Day 7||||<0.001
91621284|NCT02700919|183135928|SUPERIORITY|||||||0.102|||||||Log Rank|||Change from Baseline on Day 7||||0.102
91621285|NCT02700919|183135928|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.507|TWO_SIDED|95.0|-0.053|0.107|||Mixed Models Analysis|||Day 7||0.107|-0.053|0.507
91713416|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 4.|Wilcoxon test|||||||0.13
91713417|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7114||||||The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7114
91713418|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.|Wilcoxon test|||||||>0.9999
91660022|NCT01993030|183214746|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the Time to Wound Healing between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.02
91524893|NCT05375955|182925302|OTHER||Risk Difference (RD)|-1.6||||0.5461|TWO_SIDED|95.0|-17.7|15.3|||Chan and Zhang (1999) method|||Week 8||15.3|-17.7|0.5461
91524894|NCT05375955|182925302|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 10||24.8|-8.9|0.2736
91660023|NCT01832259|183214750|SUPERIORITY|||||||0.345|||||||t-test, 1 sided|||||||0.345
91660024|NCT01832259|183214752|SUPERIORITY|||||||0.46|||||||Log Rank|||||||0.46
91660025|NCT02996591|183214775|OTHER||generalized estimating equations method|45.0||||0.038|TWO_SIDED||||||Regression, Logistic|||||||.038
91660026|NCT02996591|183214775|OTHER|Bang blinding index|||||<|0.001|||||||Bang Blinding Index|95% confidence interval||||||<.001
91660027|NCT01980771|183214803|SUPERIORITY||Odds Ratio (OR)|1.58||||0.04|TWO_SIDED|95.0|1.03|2.43|||Mixed Models Analysis|||||2.43|1.03|0.04
91660028|NCT03450057|183214806|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
91660029|NCT03450057|183214807|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
91713419|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.|Wilcoxon test|||||||0.38
91660030|NCT03450057|183214808|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
91660031|NCT03450057|183214809|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
91660032|NCT03450057|183214810|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
91660033|NCT03450057|183214811|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
91660034|NCT00829790|183214823|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|114.49||||||90.0|109.25|119.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||119.98|109.25|
91660035|NCT00829790|183214824|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|117.16||||||90.0|110.44|124.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||124.28|110.44|
91660036|NCT00829790|183214825|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|116.7||||||90.0|109.89|123.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123.92|109.89|
91524895|NCT05375955|182925302|OTHER||Risk Difference (RD)|5.4||||0.2754|TWO_SIDED|95.0|-11.0|22.1|||Chan and Zhang (1999) method|||Week 10||22.1|-11.0|0.2754
91621286|NCT02700919|183135928|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.148|TWO_SIDED|95.0|-0.021|0.136|||Mixed Models Analysis|||Day 7||0.136|-0.021|0.148
91621287|NCT02700919|183135928|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.443|TWO_SIDED|95.0|-0.109|0.048|||Mixed Models Analysis|||Day 7||0.048|-0.109|0.443
91621288|NCT02700919|183135932|SUPERIORITY|||||||0.399|||||||Log Rank|||||||0.399
91621289|NCT02700919|183135932|SUPERIORITY|||||||0.091|||||||Log Rank|||||||0.091
91621290|NCT02700919|183135932|SUPERIORITY|||||||0.437|||||||Log Rank|||||||0.437
91621291|NCT02700919|183135936|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.720
91621292|NCT02700919|183135936|SUPERIORITY|||||||0.298|||||||Log Rank|||||||0.298
91621293|NCT02700919|183135936|SUPERIORITY|||||||0.47|||||||Log Rank|||||||0.470
91621294|NCT00915538|183135959|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The expected results for non-inferiority would be +/- 5% of difference between the two groups in the primary efficacy parameter.|AUC|0.0||||0.76|TWO_SIDED||||||t-test, 2 sided|||The cross-over means there were 16 determinants for each time for each treatment. The AUC of FEV-1 was measured in each subject for each treatment arm and the mean of this data was compared.||||0.76
91621295|NCT00915538|183135959|OTHER|Two sample T test|Mean Difference (Net)|0.0|STANDARD_DEVIATION|12.0|>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91621296|NCT00915538|183135960|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation was not done for secondary parameter. The comparison was for the FEV-1/FVC expressed as fraction at each time point||||||0.76|TWO_SIDED|95.0|||||t-test, 2 sided|||The cross over means there were 16 determinants for each time for each treatment||||0.76
91621297|NCT03864536|183135977|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
91621298|NCT03864536|183135978|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
91621299|NCT02215616|183135984|OTHER||Least square (LS) mean difference|0.78||||0.4853|TWO_SIDED|95.0|-1.42|2.98||Threshold for significance at 0.045 level.|Mixed Models Analysis|||Analysis was performed using Mixed Model Repeated Measures model (MMRM) with treatment group (3 levels: placebo, laquinimod 0.5 mg and laquinimod 1 mg), categorical week (4 levels: Weeks 4, 13, 26, and 52), treatment by week interaction, country, TMS baseline value and TMS baseline by week interaction as fixed effects. Unstructured variance-covariance structure was used in the initial model.||2.98|-1.42|0.4853
91621300|NCT04058158|183135986|EQUIVALENCE|Pre-defined equivalence margin was \[-337.2 to 337.2\].|Least squares mean difference|34.48|||||TWO_SIDED|95.0|-47.66|116.62||||||||116.62|-47.66|
91621301|NCT04058158|183135987|EQUIVALENCE|Pre-defined equivalence margin was \[0.77 to 1.29\].|Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.95|1.23||||||||1.23|0.95|
91621302|NCT01634113|183135988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.117||0.4963|TWO_SIDED|95.0|-0.312|0.152||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.152|-0.312|0.4963
91621303|NCT01634113|183135988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.123||0.6936|TWO_SIDED|95.0|-0.292|0.195||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.195|-0.292|0.6936
91621304|NCT01634113|183135990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083|STANDARD_ERROR_OF_MEAN|0.157||0.5995|TWO_SIDED|95.0|-0.229|0.394||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.394|-0.229|0.5995
91621305|NCT01634113|183135990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.16||0.9251|TWO_SIDED|95.0|-0.303|0.333||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.333|-0.303|0.9251
91621306|NCT01634113|183135991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|10.324||0.8279|TWO_SIDED|95.0|-18.243|22.743||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||22.743|-18.243|0.8279
91621307|NCT01634113|183135991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.497|STANDARD_ERROR_OF_MEAN|10.826||0.8181|TWO_SIDED|95.0|-23.987|18.994||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||18.994|-23.987|0.8181
91621308|NCT01634113|183135993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.112||0.5869|TWO_SIDED|95.0|-0.161|0.283||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.283|-0.161|0.5869
91621309|NCT01634113|183135993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.116||0.523|TWO_SIDED|95.0|-0.305|0.156||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.156|-0.305|0.5230
91621310|NCT02062463|183136063|OTHER||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.05|6.95||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||6.95|2.05|<0.001
91621311|NCT02062463|183136064|OTHER||Odds Ratio (OR)|1.26||||0.316|TWO_SIDED|95.0|0.8|1.98||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||1.98|0.80|0.316
91621312|NCT01956240|183136094|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.51|STANDARD_DEVIATION|1.9|<|0.05|TWO_SIDED|95.0|||||ANOVA|A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.||||||<0.05
91621313|NCT01956240|183136095|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0|||>|0.05|TWO_SIDED|95.0|||||ANOVA|Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.||||||>0.05
91621314|NCT03172481|183136107|OTHER|The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom SKAMP-C scores from each time point as the dependent variable. The repeated measures model adjusted means (LS-means) for PRC-063 and placebo were compared statistically using a t-test with an overall 5% significance level to evaluate efficacy. The LS-means estimate an overall treatment effect across the entire 13-hour classroom evaluation.|||||<|0.0001|||||||ANOVA|||||||<0.0001
91621315|NCT01061736|183136115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.1155|TWO_SIDED|95.0|0.85|4.64||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.||4.64|0.85|0.1155
91621316|NCT01061736|183136115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0041|TWO_SIDED|95.0|1.53|9.63||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||9.63|1.53|0.0041
91660037|NCT02865850|183214842|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.53|
91660038|NCT02865850|183214843|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.97|||=|0.995|TWO_SIDED|95.0|0.536|1.761|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.761|0.536|=0.9950
91621317|NCT01061736|183136115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.7119|TWO_SIDED|95.0|0.52|2.61||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||2.61|0.52|0.7119
91621318|NCT01061736|183136115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0363|TWO_SIDED|95.0|1.06|5.35||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.35|1.06|0.0363
91660039|NCT02865850|183214843|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
91621319|NCT01061736|183136115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0426|TWO_SIDED|95.0|1.03|5.29||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.29|1.03|0.0426
91621320|NCT01061736|183136116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.773|||<|0.0001|TWO_SIDED|95.0|2.077|3.703||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo was derived. The multiplicity issues for part B were addressed by using a Bonferroni correction for each dose together with a hierarchical testing procedure across the 3 co-primary and the main secondary endpoints. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||3.703|2.077|<0.0001
91621321|NCT01061736|183136116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.975|||<|0.0001|TWO_SIDED|95.0|2.957|5.344||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||5.344|2.957|<0.0001
91621322|NCT01061736|183136117|SUPERIORITY_OR_OTHER||LS mean difference|-0.235|||<|0.0001|TWO_SIDED|95.0|-0.312|-0.157||Threshold for significance = 0.025.|Mixed Models Analysis|||Analysis was performed using a mixed model for repeated measures (MMRM). Differences in least square (LS) mean between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoint was statistically significant).||-0.157|-0.312|<0.0001
91621323|NCT01061736|183136117|SUPERIORITY_OR_OTHER||LS mean difference|-0.258|||<|0.0001|TWO_SIDED|95.0|-0.336|-0.181||Threshold for significance = 0.025.|Mixed Models Analysis|||||-0.181|-0.336|<0.0001
91621324|NCT01061736|183136118|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||Analysis was performed using two-sided rank-based ANCOVA model. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||||<0.0001
91621325|NCT01061736|183136118|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||||||<0.0001
91660040|NCT02865850|183214844|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.34|0.19||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.19|-0.34|
91621326|NCT01061736|183136119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.661|||<|0.0001|TWO_SIDED|95.0|2.451|8.863||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||8.863|2.451|<0.0001
91621327|NCT01061736|183136119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.565|||<|0.0001|TWO_SIDED|95.0|2.946|10.515||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||10.515|2.946|<0.0001
91621328|NCT01093755|183136130|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.30
91621329|NCT01093755|183136130|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.52
91524896|NCT05375955|182925302|OTHER||Risk Difference (RD)|12.6||||0.0977|TWO_SIDED|95.0|-4.8|30.3|||Chan and Zhang (1999) method|||Week 12||30.3|-4.8|0.0977
91621330|NCT01093755|183136131|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.70
91621331|NCT01093755|183136131|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.64
91621332|NCT03115112|183136132|NON_INFERIORITY|The non-inferiority margin of 0.35% was determined based on a reference clinical trial that demonstrated the effectiveness of sitagliptin, 100 mg, compared to placebo on HbA1c reduction in subjects with type 2 DM. A margin of 0.35% was selected to be approximately half of sitagliptin effect and remained clinically meaningful.|Difference of LS Means|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||Mixed-effects repeated measures analysis includes region, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as fixed effect covariates.|||0.22|-0.07|
91621333|NCT03115112|183136133|SUPERIORITY||Difference of LS Means|-0.37||||0.0123|TWO_SIDED|95.0|-0.7|-0.05|||Mixed-effects repeated measures|Covariate includes region, treatment, visit, treatment-by-visit interaction and the baseline FPG value as a fixed effect covariate.||||-0.05|-0.70|0.0123
91621334|NCT03115112|183136134|SUPERIORITY||Difference of LS Means|-2.54|||<|0.0001|TWO_SIDED|95.0|-3.15|-1.92|||Mixed-effects repeated measures|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.||||-1.92|-3.15|<0.0001
91621335|NCT03115112|183136135|SUPERIORITY||mixed-effects repeated measures|-2.33||||0.0276|TWO_SIDED|95.0|-4.7|0.05|||t-test, 1 sided|p value was presented based on one sided statistical tests using a 0.025 level of significance|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.|||0.05|-4.70|0.0276
91621336|NCT02093234|183136140|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91621337|NCT02093234|183136141|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91621338|NCT02093234|183136142|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91621339|NCT02093234|183136143|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank|||||||0.02
91621340|NCT01170702|183136191|NON_INFERIORITY|The non inferiority margin is clinically important reduction in 24 hour hydromorphone consumption of 25%, 37.5% and 50% absolute reduction, compared with control.|Median Difference (Final Values)|1.25|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|0.975|1.25|1.25|||Kruskal-Wallis|||||1.25|1.25|.05
91621341|NCT06964165|183136228|OTHER||Difference in pre-IDS ORR|-39.0|||||TWO_SIDED|80.0|-56.8|-17.7||||||||-17.7|-56.8|
91621342|NCT01551758|183136244|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.92|||=|0.025|TWO_SIDED|95.0|0.85|0.99|||Generalized Linear Model|||||0.99|0.85|=0.025
91621343|NCT01551758|183136245|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.1|||||TWO_SIDED|95.0|0.9|1.5|||||Calculated as % of participants who had at least one SAE of pneumonia in the FF/VI group divided by the % of participants who had at least one SAE of pneumonia in the Usual Care group|||1.5|0.9|
91621344|NCT01551758|183136246|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.08||||0.632|TWO_SIDED|95.0|0.79|1.47|||Generalized linear model|||||1.47|0.79|0.632
91621345|NCT01551758|183136247|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||=|0.439|TWO_SIDED|95.0|0.83|1.52|||Cox proportional hazards model|||||1.52|0.83|=0.439
91621346|NCT01551758|183136248|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.06||||0.488|TWO_SIDED|95.0|0.89|1.27|||Generalized linear model|||||1.27|0.89|0.488
91621347|NCT01551758|183136249|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.98||||0.622|TWO_SIDED|95.0|0.92|1.05|||Generalized linear model|||||1.05|0.92|0.622
91621348|NCT01551758|183136250|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.05||||0.336|TWO_SIDED|95.0|0.95|1.15|||Generalized Linear Model|||||1.15|0.95|0.336
91621349|NCT01551758|183136251|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.05|1.2|||Generalized Linear Model|||||1.20|1.05|<0.001
91621350|NCT01551758|183136252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89|||<|0.001|TWO_SIDED|95.0|1.6|2.23|||Cox proportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care.|||2.23|1.60|<0.001
91621351|NCT01551758|183136253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.66|||Cox proprotional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||0.66|0.37|<0.001
91660041|NCT02865850|183214845|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8871|TWO_SIDED|95.0|0.618|1.743|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.743|0.618|=0.8871
91621352|NCT01551758|183136254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.111|TWO_SIDED|95.0|0.85|1.02|||Cox porportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||1.02|0.85|0.111
91621353|NCT01551758|183136255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.081|TWO_SIDED|95.0|0.84|1.01|||Cox porportional hazards model|||||1.01|0.84|0.081
91621354|NCT01551758|183136256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.075|TWO_SIDED|95.0|0.98|1.66|||Cox proportional hazards model|||||1.66|0.98|0.075
91660042|NCT02865850|183214845|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
91660043|NCT02865850|183214846|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.36|||=|0.521|TWO_SIDED|95.0|0.67|2.771|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.771|0.670|=0.5210
91660044|NCT02865850|183214846|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
91660045|NCT02865850|183214847|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.1|||=|0.9527|TWO_SIDED|95.0|0.452|2.666|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.666|0.452|=0.9527
91621355|NCT00781963|183136299|SUPERIORITY||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-28.7|-3.0|||Mixed Models Analysis||The parameter estimate is the improvement in sleep onset latency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-3.0|-28.7|<.001
91621356|NCT00781963|183136300|SUPERIORITY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|8.2||0.21|TWO_SIDED|95.0|-26.3|5.9|||Mixed Models Analysis||The parameter estimate is the improvement in wake after sleep onset from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||5.9|-26.3|0.21
91621357|NCT00781963|183136301|SUPERIORITY||Mean Difference (Final Values)|-37.0|STANDARD_ERROR_OF_MEAN|12.9||0.004|TWO_SIDED|95.0|-62.2|-11.7|||Mixed Models Analysis||The parameter estimate is the improvement in total wake time from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-11.7|-62.2|0.004
91621358|NCT00781963|183136302|SUPERIORITY||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|2.36||0.005|TWO_SIDED|95.0|2.0|11.3|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||11.3|2.0|.005
91660046|NCT02865850|183214847|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
91621359|NCT00781963|183136303|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15|TWO_SIDED|95.0|-3.3|0.5|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency (from wrist actigraphy) from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||0.5|-3.3|0.15
91621360|NCT00781963|183136304|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis||The parameter estimate is the improvement in PSQI score from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-1.3|-3.5|<.001
91621361|NCT00421603|183136357|NON_INFERIORITY_OR_EQUIVALENCE|All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.|||||=|0.05|||||||Chi-squared, Corrected|||The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).||||=.05
91621362|NCT00698035|183136369|SUPERIORITY_OR_OTHER||||||>|0.05||||||Significant at p\<0.05|t-test, 2 sided|||Comparison of baseline estradiol between LC/MS and RIA||||>0.05
91621363|NCT00698035|183136369|SUPERIORITY_OR_OTHER||||||>|0.05||||||singificant at p\<0.05|t-test, 2 sided|||Comparison of week 4 estradiol between LC/MS and RIA||||>0.05
91621364|NCT00698035|183136372|SUPERIORITY_OR_OTHER|||||||0.021||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.021
91621365|NCT00698035|183136372|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
91621366|NCT00698035|183136372|SUPERIORITY_OR_OTHER|||||||0.0228||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.0228
91660047|NCT02865850|183214848|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.78|||=|0.5115|TWO_SIDED|95.0|0.388|1.555|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.555|0.388|=0.5115
91660048|NCT02865850|183214848|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
91660049|NCT00552669|183214859|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||We used One way annalysis of a variance for means and standard deviation.||||<0.05
91660050|NCT00552669|183214860|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)||||0.05
91621367|NCT00698035|183136372|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
91621368|NCT00698035|183136373|SUPERIORITY_OR_OTHER|||||||0.004||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.004
91621369|NCT00698035|183136373|SUPERIORITY_OR_OTHER|||||||0.139||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.139
91621370|NCT00698035|183136374|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12||||<0.001
91621371|NCT00698035|183136374|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks||||<0.001
91524897|NCT05375955|182925302|OTHER||Risk Difference (RD)|14.9||||0.0542|TWO_SIDED|95.0|-2.8|33.2|||Chan and Zhang (1999) method|||Week 12||33.2|-2.8|0.0542
91621372|NCT00698035|183136374|SUPERIORITY_OR_OTHER|||||||0.0061||||||Significant at p\<0.05|t-test, 2 sided|||Difference in petechiae between baseline and week 12||||0.0061
91621373|NCT00654953|183136418|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|degrees of freedom for medication group = 2 (group)||The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.||||0.05
91621374|NCT01231607|183136419|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|22.0||||0.046|TWO_SIDED|98.33|-4.4|48.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.|||48.4|-4.4|0.046
91660051|NCT00552669|183214861|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one."||||<0.05
91660052|NCT00252720|183214870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.8487|TWO_SIDED|95.0|0.8|1.312|||Log Rank|Generalized||||1.312|0.800|0.8487
91660053|NCT00102440|183214876|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|32.0||||||97.5|23.1|41.3||||||||41.3|23.1|
91722450|NCT01932606|183337701|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure.||||0.002
91621375|NCT01231607|183136419|SUPERIORITY_OR_OTHER||LS mean difference|67.9|||<|0.001|TWO_SIDED|98.33|41.6|94.2|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.|||94.2|41.6|<0.001
91524898|NCT05375955|182925303|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
91524899|NCT05375955|182925303|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
91524900|NCT05375955|182925303|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 1||24.3|-2.1|0.0436
91524901|NCT05375955|182925303|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
91524902|NCT05375955|182925303|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 2||14.9|-7.8|0.2697
91524903|NCT05375955|182925303|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 2||32.0|3.2|0.0104
91621376|NCT01231607|183136419|SUPERIORITY_OR_OTHER||LS mean difference|94.4|||<|0.001|TWO_SIDED|98.33|67.8|121.0|||General linear model|Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.|Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.|||121.0|67.8|<0.001
91722451|NCT01932606|183337701|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between the 2 arms for change in PCWP.||||<0.0001
91621377|NCT01231607|183136419|SUPERIORITY_OR_OTHER||Least squares mean difference|61.4|||<|0.001|TWO_SIDED|98.33|34.4|88.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.|||88.4|34.4|<0.001
91621378|NCT01231607|183136419|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|-39.4|||<|0.001||99.165|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
91660054|NCT00102440|183214876|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|41.0||||||97.5|31.5|49.5||||||||49.5|31.5|
91660055|NCT00102440|183214876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
91660056|NCT00102440|183214876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
91660057|NCT00102440|183214876|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.072
91660058|NCT00102440|183214877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
91660059|NCT00102440|183214877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
91660060|NCT00102440|183214877|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.031
91660061|NCT00102440|183214878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
91621379|NCT01231607|183136419|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|6.5||||0.28||99.165|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.28
91621380|NCT01231607|183136419|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|33.0||||0.002||99.165|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.002
91621381|NCT01231607|183136419|SUPERIORITY_OR_OTHER||Least squares mean difference|-39.4|||<|0.001|TWO_SIDED|98.33|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
91621382|NCT01231607|183136419|SUPERIORITY_OR_OTHER||Least squares mean difference|6.5||||0.56|TWO_SIDED|98.33|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.56
91621383|NCT01231607|183136419|SUPERIORITY_OR_OTHER||Least squares mean difference|33.0||||0.003|TWO_SIDED|98.33|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.003
91621384|NCT01709786|183136439|SUPERIORITY_OR_OTHER||Bland-Altman Analysis|1.49|||||TWO_SIDED|||||p-value is not reported since Bland-Altman is not a hypothesis testing framework.|Limits of agreement||Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
91621385|NCT01709786|183136440|SUPERIORITY_OR_OTHER||Limits of agreement|-0.63|||||TWO_SIDED|||||p-value not reported since Bland-Altman is not a hypothesis testing framework.|Bland-Altman Analysis||Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
91621386|NCT03779334|183136441|SUPERIORITY||||||<|0.0001|||||||Exact Binomial Test|Performance Criterion = 5%||||||<0.0001
91621387|NCT06533475|183136469|OTHER||GLSM Ratio|1.018|||||TWO_SIDED|90.0|0.9624|1.076|||||The GLSM ratio was calculated: Minzasolmin tablet (Fasted)/ Minzasolmin Capsule (Fasted)|||1.076|0.9624|
91660062|NCT00102440|183214878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
91660063|NCT00102440|183214878|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.883
91660064|NCT00102440|183214879|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
91660065|NCT00102440|183214879|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
91660066|NCT00102440|183214879|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.164
91660067|NCT00102440|183214880|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660068|NCT00102440|183214880|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91621388|NCT06533475|183136469|OTHER||GLSM Ratio|1.075|||||TWO_SIDED|90.0|1.024|1.13|||||"The GLSM ratio was calculated as:~Minzasolmin Tablet (Fed)/Minzasolmin Tablet (Fasted)."|||1.130|1.024|
91621389|NCT06533475|183136470|OTHER||GLSM Ratio|1.02|||||TWO_SIDED|90.0|0.9649|1.078|||||The GLSM ratio was calculated as: Minzasolmin tablet (Fasted)/ Minzasolmin Capsule (Fasted)|||1.078|0.9649|
91621390|NCT06533475|183136470|OTHER||GLSM Ratio|1.073|||||TWO_SIDED|90.0|1.021|1.127|||||"The GLSM ratio was calculated as:~Minzasolmin Tablet (Fed)/Minzasolmin Tablet (Fasted)."|||1.127|1.021|
91621391|NCT06533475|183136471|OTHER||GLSM Ratio|0.9771||||||90.0|0.7966|1.199|||||The GLSM ratio was calculated as: Minzasolmin tablet (Fasted)/ Minzasolmin Capsule (Fasted)|||1.199|0.7966|
91621392|NCT06533475|183136471|OTHER||GLSM Ratio|1.016|||||TWO_SIDED|90.0|0.794|1.299|||||The GLSM ratio was calculated as: Minzasolmin tablet (Fed)/ Minzasolmin tablet (Fasted)|||1.299|0.7940|
91621393|NCT01082367|183136504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55|||<|0.001|TWO_SIDED|95.0|4.67|99.52|||Regression, Logistic|||||99.52|4.67|<0.001
91621394|NCT00664755|183136507|SUPERIORITY||Odds Ratio (OR)|2.77||||0.011|TWO_SIDED|95.0|1.17|6.59|||Regression, Logistic|||||6.59|1.17|0.011
91621395|NCT02307838|183136515|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.59||||0.0155|TWO_SIDED|95.0|-1.07|-0.11|||ANCOVA|||||-0.11|-1.07|0.0155
91660069|NCT00102440|183214880|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660070|NCT00102440|183214881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660071|NCT00102440|183214881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660072|NCT00102440|183214881|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||0.006
91660073|NCT00102440|183214882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660074|NCT00102440|183214882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660075|NCT00102440|183214882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
91660076|NCT00102440|183214883|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||>0.999
91660077|NCT00102440|183214883|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.011
91660078|NCT00102440|183214883|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.024
91660079|NCT00102440|183214884|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.083
91722452|NCT01932606|183337702|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
91621396|NCT00865189|183136557|SUPERIORITY_OR_OTHER|||||||0.015|||||||Binomial test|||This proportion was described for each treatment arm with a 95% confidence interval (CI) and compared with the standard proportion of 10% (CI) for each treatment arm.||||0.015
91621397|NCT00865189|183136557|SUPERIORITY_OR_OTHER|||||||0.906|||||||Binomial test|||This proportion was described for each treatment arm with a 95% CI and compared with the standard proportion of 10% (CI) using for each treatment arm.||||0.906
91621398|NCT01658579|183136569|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|2.179||0.7304|TWO_SIDED|95.0|-3.614|5.124|||Linear Mixed Model|||Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.||5.124|-3.614|0.7304
91621399|NCT03641547|183136579|OTHER||Post prob of tox at dose level 6|0.029|||||TWO_SIDED|95.0|0.0|0.165||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.165|0|
91621400|NCT03641547|183136580|OTHER||Post prob of tox at dose level 4|0.185|||||TWO_SIDED|95.0|0.042|0.397||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.397|0.042|
91621401|NCT02767856|183136591|EQUIVALENCE|The study did not enroll enough samples. The stats here are only for reference.|Mean Difference (Net)|0.04||||0.48|TWO_SIDED|95.0|-0.08|0.16|||t-test, 2 sided|||Baseline and primary visit outcome||0.16|-0.08|0.48
91621402|NCT02767856|183136592|EQUIVALENCE|The study did not reach the target sample size. the stats are for reference.|Mean Difference (Final Values)|0.12||||0.26|TWO_SIDED|95.0|-0.75|0.99|||t-test, 2 sided|||||0.99|-0.75|0.26
91621403|NCT02767856|183136593|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|26.3||||0.26|TWO_SIDED|95.0|-21.75|74.2|||t-test, 2 sided|||||74.20|-21.75|0.26
91621404|NCT02767856|183136594|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|11.1||||0.44|TWO_SIDED|95.0|-41.3|19.3|||t-test, 2 sided|||||19.3|-41.3|0.44
91621405|NCT00418379|183136604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
91621406|NCT00418379|183136604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
91621407|NCT05127044|183136609|OTHER|An a priori power analysis was conducted to determine the number of subjects needed to detect a similar strong correlation between the DRS and BiliChek data (α = 0.05, power = 0.8, r0 = 0.7, r1 = 0,85; G\*Power3.1). For this study n = 44 subjects (from Study Protocol).|Multiple R|0.81438645|||||TWO_SIDED|||||||||Power calculation located in Study Protocol-Correlation Coefficient-R Value||||
91621408|NCT05127044|183136609|OTHER|An a priori power analysis was conducted to determine the number of subjects needed to detect a similar strong correlation between the DRS and BiliChek data (α = 0.05, power = 0.8, r0 = 0.7, r1 = 0,85; G\*Power3.1). For this study n = 44 subjects (from Study Protocol).|Multiple R|0.85442277|||||TWO_SIDED|||||||||Power calculation located in Study Protocol||||
91621409|NCT05127044|183136609|OTHER|An a priori power analysis was conducted to determine the number of subjects needed to detect a similar strong correlation between the DRS and BiliChek data (α = 0.05, power = 0.8, r0 = 0.7, r1 = 0,85; G\*Power3.1). For this study n = 44 subjects (from Study Protocol).|Multiple R|0.0758872|||||TWO_SIDED|||||||||Power calculation located in Study Protocol||||
91621410|NCT05127044|183136609|OTHER|An a priori power analysis was conducted to determine the number of subjects needed to detect a similar strong correlation between the DRS and BiliChek data (α = 0.05, power = 0.8, r0 = 0.7, r1 = 0,85; G\*Power3.1). For this study n = 44 subjects (from Study Protocol).|Multiple R|0.7929338|||||TWO_SIDED|||||||||Power calculation located in Study Protocol||||
91621411|NCT05127044|183136609|OTHER|An a priori power analysis was conducted to determine the number of subjects needed to detect a similar strong correlation between the DRS and BiliChek data (α = 0.05, power = 0.8, r0 = 0.7, r1 = 0,85; G\*Power3.1). For this study n = 44 subjects (from Study Protocol).|Multiple R|0.86294585|||||TWO_SIDED|||||||||Power calculation located in Study Protocol||||
91621412|NCT05127044|183136610|OTHER|Pearson's correlation coefficient was calculated to assess the relationship between hemoglobin concentration and weight.|Pearson Correlation Coefficient|-0.2184||||0.1544|TWO_SIDED||||||Linear correlation|||||||0.1544
91621413|NCT05127044|183136610|OTHER|Pearson's correlation coefficient was calculated to assess the relationship between hemoglobin concentration and gestational age.|Pearson Correlation Coefficient|0.3909||||0.0087|||||||Linear correlation|||||||0.0087
91621414|NCT05127044|183136610|OTHER|A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and sex as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.0252||||0.3038|TWO_SIDED||||||Regression, Linear|||||||0.3038
91621415|NCT05127044|183136610|OTHER|A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and ethnicity as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.0213||||0.6434|TWO_SIDED||||||Regression, Linear|||||||0.6434
91621416|NCT05127044|183136610|OTHER|A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and weight as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.0477||||0.1544|TWO_SIDED||||||Regression, Linear|||||||0.1544
91621417|NCT05127044|183136610|OTHER|A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and gestational age as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.1528||||0.0087|TWO_SIDED||||||Regression, Linear|||||||0.0087
91621418|NCT05127044|183136611|OTHER|Pearson's correlation coefficient was calculated to assess the relationship between melanin concentration and weight.|Pearson Correlation Coefficient|-0.1552||||0.3143|TWO_SIDED||||||Linear correlation|||||||0.3143
91713420|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.91||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.|Wilcoxon test|||||||0.91
91713421|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2666||||||The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2666
91660080|NCT00102440|183214884|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.164
91660081|NCT00102440|183214884|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.619
91660082|NCT00102440|183214885|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.080
91660083|NCT00102440|183214885|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.372
91660084|NCT00102440|183214885|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.246
91713422|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.88
91524904|NCT05375955|182925303|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
91660085|NCT00102440|183214886|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.674
91660086|NCT00102440|183214886|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
91660087|NCT00102440|183214886|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.411
91660088|NCT00102440|183214887|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.507
91660089|NCT00102440|183214887|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.188
91660090|NCT00102440|183214887|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.362
91660091|NCT00102440|183214888|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.657
91660092|NCT00102440|183214888|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.444
91660093|NCT00102440|183214888|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.719
91660094|NCT00102440|183214889|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.999
91660095|NCT00102440|183214889|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.229
91660096|NCT00102440|183214889|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.266
91660097|NCT04627038|183214890|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.51|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.51|
91660098|NCT04627038|183214891|SUPERIORITY||Posterior Mean Difference|0.95|||||TWO_SIDED|95.0|-0.07|1.96|||||Posterior mean difference with 95% credible interval is reported.|||1.96|-0.07|
91660099|NCT04627038|183214892|SUPERIORITY||Posterior Mean Difference|0.24|||||TWO_SIDED|95.0|-0.24|0.72|||||Posterior mean difference with 95% credible interval is reported.|||0.72|-0.24|
91660100|NCT04627038|183214893|SUPERIORITY||Posterior Mean Difference|3.84|||||TWO_SIDED|95.0|0.39|7.2|||||Posterior mean difference with 95% credible interval is reported.|||7.20|0.39|
91713423|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.45||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.45
91713424|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 4.|Wilcoxon test|||||||0.36
91621419|NCT05127044|183136611|OTHER|Pearson's correlation coefficient was calculated to assess the relationship between melanin concentration and gestational age.|Pearson Correlation Coefficient|-0.0832||||0.5914|TWO_SIDED||||||Linear correlation|||||||0.5914
91621420|NCT05127044|183136611|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and sex as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.000665||||0.868|TWO_SIDED||||||Regression, Linear|||||||0.868
91621421|NCT05127044|183136611|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and ethnicity as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.574||||0.0001|TWO_SIDED||||||Regression, Linear|||||||0.0001
91621422|NCT05127044|183136611|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and weight as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.0241||||0.3143|TWO_SIDED||||||Regression, Linear|||||||0.3143
91621423|NCT05127044|183136611|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and gestational age as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.0069||||0.5914|TWO_SIDED||||||Regression, Linear|||||||0.5914
91621424|NCT05127044|183136612|OTHER|Pearson's correlation coefficient was calculated to assess the relationship between bilirubin concentration and weight.|Pearson Correlation Coefficient|-0.0353||||0.8203|TWO_SIDED||||||Linear correlation|||||||0.8203
91660101|NCT04627038|183214894|SUPERIORITY||Posterior Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.48|0.28|||||Posterior mean difference with 95% credible interval is reported.|||0.28|-0.48|
91621425|NCT05127044|183136612|OTHER|Pearson's correlation coefficient was calculated to assess the relationship between bilirubin concentration and gestational age.|Pearson Correlation Coefficient|0.595||||0.0001|TWO_SIDED||||||Linear correlation|||||||0.0001
91621426|NCT05127044|183136612|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and sex as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.0363||||0.2156|TWO_SIDED||||||Regression, Linear|||||||0.2156
91621427|NCT05127044|183136612|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and ethnicity as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.2172||||0.0066|TWO_SIDED||||||Regression, Linear|||||||0.0066
91621428|NCT05127044|183136612|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and weight as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.00124||||0.8203|TWO_SIDED||||||Regression, Linear|||||||0.8203
91621429|NCT05127044|183136612|OTHER|A simple linear regression model was fitted with melanin concentration as the dependent variable and gestational age as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²).|Coefficient of determination|0.354||||0.0001|TWO_SIDED||||||Regression, Linear|||||||0.0001
91621430|NCT00400712|183136642|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANCOVA|Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05||||||0.44
91621431|NCT00400712|183136643|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.83
91621432|NCT00400712|183136644|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||ANCOVA - comparing absolute measures and including baseline as co-variate||||0.45
91621433|NCT00400712|183136645|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|adjusted for baseline values||||||0.72
91621434|NCT00400712|183136646|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANCOVA|controlled for baseline values||||||0.60
91621435|NCT00400712|183136647|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.66
91621436|NCT00400712|183136648|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.78
91621437|NCT00414960|183136774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.04||0.556|TWO_SIDED|95.0|-10.64|5.83||P-value is for comparison of change from baseline between enzastaurin and placebo group.|2-sample pooled t-test||Using placebo as a reference group, the mean difference = enzastaurin minus placebo.|||5.83|-10.64|0.556
91660102|NCT04627038|183214895|SUPERIORITY||Posterior Mean Difference|0.31|||||TWO_SIDED|95.0|-0.32|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.32|
91660103|NCT04627038|183214896|SUPERIORITY||Posterior Mean Difference|6.24|||||TWO_SIDED|95.0|-1.05|13.56|||||Posterior mean difference with 95% credible interval is reported.|||13.56|-1.05|
91660104|NCT04627038|183214897|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.14|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.14|
91660105|NCT04627038|183214898|SUPERIORITY||Posterior Mean Difference|-0.82|||||TWO_SIDED|95.0|-166.74|165.52|||||Posterior mean difference with 95% credible interval is reported.|||165.52|-166.74|
91660106|NCT04627038|183214899|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.09|0.06|||||Posterior mean difference with 95% credible interval is reported.|||0.06|-0.09|
91621438|NCT00363246|183136789|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.049
91621439|NCT00363246|183136789|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.013
91621440|NCT00363246|183136789|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.0001
91621441|NCT00363246|183136789|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.009
91621442|NCT00363246|183136790|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|We used chi-squared test for categorical variable (most variables) and t-test (2-sided) for continuous variables (few variables).||Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.033
91660107|NCT00473330|183214950|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.3|||<|0.0001|TWO_SIDED|95.0|13.8|34.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||34.8|13.8|<0.0001
91660108|NCT00473330|183214950|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.9||||0.0002|TWO_SIDED|95.0|10.7|31.1||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.1|10.7|0.0002
91660109|NCT00473330|183214951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001|TWO_SIDED|95.0|6.1|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.0|6.1|<0.0001
91660110|NCT00473330|183214951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.0001|TWO_SIDED|95.0|6.2|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|6.2|<0.0001
91621443|NCT00363246|183136790|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.013
91691904|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.31||0.4301||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.4301
91524905|NCT05375955|182925303|OTHER||Risk Difference (RD)|14.3||||0.0129|TWO_SIDED|95.0|2.6|30.3|||Chan and Zhang (1999) method|||Week 4||30.3|2.6|0.0129
91524906|NCT05375955|182925303|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 4||38.9|8.0|0.0024
91621444|NCT00363246|183136790|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||<0.001
91621445|NCT00363246|183136790|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.007
91621446|NCT00383721|183136859|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91621447|NCT00383721|183136859|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91621448|NCT00383721|183136860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|||||||0.062
91524907|NCT05375955|182925303|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 6||38.9|8.0|0.0024
91621449|NCT00383721|183136860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.583|||||||ANCOVA|||||||0.583
91660111|NCT00473330|183214952|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.4|||<|0.0001|TWO_SIDED|95.0|13.4|35.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||35.4|13.4|<0.0001
91713425|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0076||||||The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0076
91621450|NCT00383721|183136861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||ANCOVA|||||||0.020
91621451|NCT00383721|183136861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91621452|NCT00132314|183136869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.39|TWO_SIDED|95.0|0.63|1.2|||Log Rank|||Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.||1.20|0.63|0.39
91621453|NCT00132314|183136870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.63|1.2||95% Confidence Interval: 0.63 to 1.20|Regression, Cox|||||1.20|0.63|
91621454|NCT05137730|183136974|OTHER||Ratio of geometric least squares means|0.78|||||TWO_SIDED|90.0|0.7109|0.8611|||||Least squares means (LSMs) were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8611|0.7109|
91621455|NCT05137730|183136975|OTHER||Dose effect|1.5395|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|1.2929|1.7862||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.7862|1.2929|
91621456|NCT05137730|183136976|OTHER||Ratio of geometric least squares means|0.84|||||TWO_SIDED|90.0|0.7576|0.9375|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.9375|0.7576|
91621457|NCT05137730|183136977|OTHER||Dose effect|1.2823|STANDARD_ERROR_OF_MEAN|0.1072|||TWO_SIDED|95.0|1.0431|1.5215||||||A linear regression model using was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.5215|1.0431|
91621458|NCT05137730|183136978|OTHER||Ratio of geometric least squares means|0.81|||||TWO_SIDED|90.0|0.7462|0.8893|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8893|0.7462|
91621459|NCT05137730|183136979|OTHER||Dose effect|1.0937|STANDARD_ERROR_OF_MEAN|0.0763|||TWO_SIDED|95.0|0.938|1.2493||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.2493|0.9380|
91621460|NCT01840228|183136984|SUPERIORITY||Risk Ratio (RR)|1.1||||0.74|TWO_SIDED|95.0|0.63|1.91|||Chi-squared|||||1.91|0.63|0.74
91621461|NCT01840228|183136985|SUPERIORITY||Risk Ratio (RR)|0.43||||0.13|TWO_SIDED|95.0|0.14|1.36|||Fisher Exact|||||1.36|0.14|0.13
91621462|NCT01840228|183136986|SUPERIORITY||Risk Ratio (RR)|1.5||||0.71|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.71
91524908|NCT05375955|182925303|OTHER||Risk Difference (RD)|22.9||||0.0018|TWO_SIDED|95.0|9.5|40.1|||Chan and Zhang (1999) method|||Week 6||40.1|9.5|0.0018
91621463|NCT01840228|183136987|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91621464|NCT01413542|183137030|SUPERIORITY_OR_OTHER||Estimate of Difference||||<|0.001|TWO_SIDED|||||Effect of ACE inhibition on FBF response to bradykinin (p\<0.001). Other comparisons: Effect of DPP4 inhibition on FBF response to bradykinin (p=0.89); Effect of ACE (p=0.16), DPP4 (p=0.82), or combined inhibition (p=0.35) on FBF response to sub P.|Mixed Models Analysis|"Effect of DPP4 inhibition on vasodilator response to GLP-1 (p=0.14) or BNP (p=0.85).~p\<0.05 threshold for statistical significance."||"Group 1: The effect of treatment (placebo, ACE or DPP4 inhibitor, or the combination) on vasodilator response to peptide, measured as forearm blood flow was determined.~Group 2: The effect of treatment (placebo, DPP4 inhibitor) on vasodilator response to peptide, measured as percent change in forearm blood flow was determined."||||<0.001
91621465|NCT01413542|183137031|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Effect of DPP4 inhibition on tPA release during sub P in women (p=0.02 vs. placebo).Effect of ACE inhibition on tPA release during sub P in women (p\<0.001); effect of DPP4 inhibition on tPA release during sub P and (p=0.001 vs. ACE inhibition alone).|Mixed Models Analysis|p\<0.05 threshold for statistical significance||||||0.02
91621466|NCT01413542|183137032|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Effect of combined ACE and DPP4 inhibition on change in heart rate in response to max dose substance P (p=0.011 vs placebo; ).|Wilcoxon signed rank|p\<0.05 threshold for statistical significance.||||||0.011
91621467|NCT01413542|183137033|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with placebo.|Wilcoxon signed rank|||||||0.05
91621468|NCT01413542|183137033|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with ACE inhibition alone (p=0.007).|Wilcoxon signed rank|||||||0.007
91621469|NCT01413542|183137034|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during placebo (p=0.01).|wilxocon signed rank test|||||||0.01
91621470|NCT01413542|183137034|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during sitagliptin (p=0.01).|Wilcoxon signed rank|||||||0.01
91621471|NCT01413542|183137034|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Effect of DPP4 inhibition on venous GLP-1 levels at high dose of intra-arterial GLP-1 (p=0.04 vs. placebo).|Wilcoxon signed rank|||||||0.04
91621472|NCT01148563|183137035|SUPERIORITY||Risk Ratio, log|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||bootstrapping||The hypothesis test was based on ln(relative risk), with the tele-monitoring group value as the relative risk numerator and the control group value as the denominator. The standard error was generated by bootstrapping the sample.|||0.05|-0.65|0.094
91621473|NCT01148563|183137036|SUPERIORITY||Risk Ratio, log|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.105|TWO_SIDED|95.0|0.45|1.08|||bootstrapping|The standard error was generated by bootstrapping the sample.|The hypothesis test was based on ln(relative risk) with the tele-monitoring group value as the numerator and the control group as the denominator.|||1.08|0.45|0.105
91713426|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.|Wilcoxon test|||||||0.38
91713427|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.22||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.|Wilcoxon test|||||||0.22
91621474|NCT01879319|183137039|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|||||TWO_SIDED|95.0|-11.2|6.1||||||||6.1|-11.2|
91621475|NCT01879319|183137040|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.9|9.7||||||||9.7|-2.9|
91621476|NCT00084929|183137043|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.933||||||Accuracy: ROC analysis Receiver-operating-characteristic (ROC) curves were estimated with the use of data pooled from the radiologists because of the small number of positive cases reviewed by each radiologist.||0.933|0.853|
91621477|NCT00084929|183137043|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.838|0.96|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|"Sensitivity, for each radiologist, was calculated as the percentage of patients with lesions that were larger than or equal to the prespecified threshold and that were detected on both colonoscopy and CT colonography.~The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated."||0.96|0.838|
91621478|NCT00084929|183137043|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.813|0.9|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Specificity, for each radiologist, was calculated as the percentage of patients who did not have lesions larger than the prespecified threshold on colonoscopy as well as CT colonography The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.||0.9|0.813|
91621479|NCT00084929|183137043|OTHER||"P(D+|T+)"|0.23|||||TWO_SIDED|95.0|0.194|0.273|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Positive Predictive Value (PPV) the positive predictive value was calculated as the percentage of patients with CT colonographic findings that were also seen on colonoscopy||0.273|0.194|
91621480|NCT00084929|183137043|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Negative Predictive Value (NPV) the negative predictive value was calculated as the percentage of patients with no CT colonographic findings larger than the prespecified threshold that were not detected on colonoscopy.||0.998|0.990|
91621481|NCT00084929|183137044|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.93||||||"Accuracy: ROC analysis CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.93|0.853|
91621482|NCT00084929|183137044|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.832|0.96|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|"Sensitivity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.96|0.832|
91621483|NCT00084929|183137044|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.817|0.902|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|"Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.902|0.817|
91621484|NCT00084929|183137044|OTHER||"P(D+|T+)"|0.25|||||TWO_SIDED|95.0|0.209|0.292||||||"Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.292|0.209|
91621485|NCT00084929|183137044|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998||||||"Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.998|0.990|
91621486|NCT00084929|183137045|OTHER||Area Under the Curve (AUC)|0.88|||||TWO_SIDED|95.0|0.842|0.913||||||Accuracy: ROC analysis||0.913|0.842|
91621487|NCT00084929|183137045|OTHER||"Sensitivity: P(T+|D+)"|0.87|||||TWO_SIDED|95.0|0.803|0.929|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.929|0.803|
91621488|NCT00084929|183137045|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.825|0.909|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.909|0.825|
91621489|NCT00084929|183137045|OTHER||"P(D+|T+)"|0.31|||||TWO_SIDED|95.0|0.256|0.355||||||Positive Predictive Value (PPV)||0.355|0.256|
91621490|NCT00084929|183137045|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.984|0.994||||||Negative Predictive Value (NPV)||0.994|0.984|
91621491|NCT00084929|183137046|OTHER||Area Under the Curve (AUC)|0.87|||||TWO_SIDED|95.0|0.833|0.902||||||Accuracy: ROC analysis||0.902|0.833|
91621492|NCT00084929|183137046|OTHER||"Sensitivity: P(T+|D+)"|0.84|||||TWO_SIDED|95.0|0.776|0.912|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.912|0.776|
91621493|NCT00084929|183137046|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.831|0.914|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.914|0.831|
91621494|NCT00084929|183137046|OTHER||"P(D+|T+)"|0.35|||||TWO_SIDED|95.0|0.299|0.397||||||Positive Predictive Value (PPV)||0.397|0.299|
91621495|NCT00084929|183137046|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.98|0.992||||||Negative Predictive Value (NPV)||0.992|0.980|
91621496|NCT00084929|183137047|OTHER||Area Under the Curve (AUC)|0.84|||||TWO_SIDED|95.0|0.81|0.878||||||Accuracy: ROC analysis||0.878|0.810|
91621497|NCT00084929|183137047|OTHER||"Sensitivity: P(T+|D+)"|0.78|||||TWO_SIDED|95.0|0.711|0.849|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.849|0.711|
91621498|NCT00084929|183137047|OTHER||"P(T-|D-)"|0.88|||||TWO_SIDED|95.0|0.84|0.92|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.92|0.840|
91621499|NCT00084929|183137047|OTHER||"P(D+|T+)"|0.4|||||TWO_SIDED|95.0|0.335|0.463||||||Positive Predictive Value (PPV)||0.463|0.335|
91524909|NCT05375955|182925303|OTHER||Risk Difference (RD)|33.3||||0.0001|TWO_SIDED|95.0|17.8|51.8|||Chan and Zhang (1999) method|||Week 6||51.8|17.8|0.0001
91621500|NCT00084929|183137047|OTHER||"P(D-|T-)"|0.98|||||TWO_SIDED|95.0|0.971|0.984||||||Negative Predictive Value (NPV)||0.984|0.971|
91621501|NCT00084929|183137048|OTHER||Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.763|0.828||||||Accuracy: ROC analysis||0.828|0.763|
91621502|NCT00084929|183137048|OTHER||"Sensitivity: P(T+|D+)"|0.65|||||TWO_SIDED|95.0|0.579|0.727|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.727|0.579|
91621503|NCT00084929|183137048|OTHER||"P(T-|D-)"|0.89|||||TWO_SIDED|95.0|0.851|0.923|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.923|0.851|
91621504|NCT00084929|183137048|OTHER||"P(D+|T+)"|0.45|||||TWO_SIDED|95.0|0.389|0.513||||||Positive Predictive Value (PPV)||0.513|0.389|
91621505|NCT00084929|183137048|OTHER||"P(D-|T-)"|0.95|||||TWO_SIDED|95.0|0.941|0.965||||||Negative Predictive Value (NPV)||0.965|0.941|
91621506|NCT00084929|183137049|OTHER||"Sensitivity: P(T+|D+)"|0.84|STANDARD_ERROR_OF_MEAN|0.043|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=10mm))||||
91621507|NCT00084929|183137050|OTHER||"Sensitivity: P(T+|D+)"|0.82|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=9mm))||||
91621508|NCT00084929|183137051|OTHER||"Sensitivity: P(T+|D+)"|0.8|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=8mm)||||
91621509|NCT00084929|183137052|OTHER||"Sensitivity: P(T+|D+)"|0.75|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=7mm)||||
91621510|NCT00084929|183137053|OTHER||"Sensitivity: P(T+|D+)"|0.7|STANDARD_ERROR_OF_MEAN|0.046|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=6mm)||||
91621511|NCT00084929|183137054|OTHER||"Sensitivity: P(T+|D+)"|0.59|STANDARD_ERROR_OF_MEAN|0.045|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=5mm)||||
91621512|NCT00091026|183137062|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.22|TWO_SIDED|95.0|-13.0|14.0|||Chi-squared|||||14|-13|0.22
91621513|NCT00091026|183137063|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|||||||0.95
91621514|NCT00091026|183137064|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Log Rank|||||||0.86
91713428|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.|Wilcoxon test|||||||0.10
91524910|NCT05375955|182925303|OTHER||Risk Difference (RD)|15.2||||0.0259|TWO_SIDED|95.0|-0.1|32.5|||Chan and Zhang (1999) method|||Week 8||32.5|-0.1|0.0259
91621515|NCT00065442|183137065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.032|TWO_SIDED|95.0|0.614|0.979|||Regression, Cox|Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.|sipuleucel-T/placebo|||0.979|0.614|0.032
91621516|NCT00065442|183137065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.766||||0.023|TWO_SIDED|95.0|0.608|0.965|||Log Rank|Stratified by randomization strata.|Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)|||0.965|0.608|0.023
91621517|NCT00065442|183137066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.951||||0.628|TWO_SIDED|95.0|0.773|1.169|||Log Rank|Stratified by randomization strata|Cox regression model with treatment as the independent variable, stratified by randomization strata|||1.169|0.773|0.628
91621518|NCT01797965|183137083|SUPERIORITY|||||||0.5937|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.5937
91621519|NCT01797965|183137083|SUPERIORITY|||||||0.6233|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.6233
91621520|NCT01797965|183137083|SUPERIORITY|||||||0.1884|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.1884
91621521|NCT01797965|183137084|SUPERIORITY|||||||0.0204|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.0204
91713429|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7144||||||The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7144
91621522|NCT01797965|183137084|SUPERIORITY|||||||0.0805|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.0805
91621523|NCT01797965|183137084|SUPERIORITY|||||||0.2535|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2535
91621524|NCT01797965|183137084|SUPERIORITY|||||||0.4738|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.4738
91621525|NCT01797965|183137084|SUPERIORITY|||||||0.2302|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.2302
91621526|NCT01797965|183137084|SUPERIORITY|||||||0.8522|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8522
91621527|NCT01797965|183137084|SUPERIORITY|||||||0.0431|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.0431
91621528|NCT01797965|183137084|SUPERIORITY|||||||0.0339|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.0339
91621529|NCT01797965|183137084|SUPERIORITY|||||||0.3195|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.3195
91691905|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.3125||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.3125
91524911|NCT05375955|182925303|OTHER||Risk Difference (RD)|22.8||||0.0038|TWO_SIDED|95.0|6.3|40.4|||Chan and Zhang (1999) method|||Week 8||40.4|6.3|0.0038
91621530|NCT01797965|183137084|SUPERIORITY|||||||0.2119|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.2119
91621531|NCT01797965|183137084|SUPERIORITY|||||||0.3619|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.3619
91621532|NCT01797965|183137084|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.0170
91621533|NCT01797965|183137084|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.0170
91621534|NCT01797965|183137084|SUPERIORITY|||||||0.0849|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.0849
91621535|NCT01797965|183137084|SUPERIORITY|||||||0.0057|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.0057
91621536|NCT01797965|183137084|SUPERIORITY|||||||0.396|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.3960
91621537|NCT01797965|183137086|SUPERIORITY||Odds Ratio (OR)|0.902||||0.8417|TWO_SIDED|95.0|0.329|2.473|||Regression, Logistic|Adjusted for the baseline relapse rate, history of prior IFN beta use (yes/no), baseline EDSS (\<=2.5 vs \>2.5) and baseline age (\<=35 vs \>35).||||2.473|0.329|0.8417
91621538|NCT01797965|183137108|SUPERIORITY|||||||0.3813|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.3813
91722453|NCT01932606|183337703|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.11
91621539|NCT01797965|183137108|SUPERIORITY|||||||0.1679|||||||ANOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.1679
91621540|NCT01797965|183137108|SUPERIORITY|||||||0.5634|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.5634
91621541|NCT01797965|183137108|SUPERIORITY|||||||0.7003|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 144||||0.7003
91621542|NCT01797965|183137108|SUPERIORITY|||||||0.7812|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 168||||0.7812
91621543|NCT01797965|183137108|SUPERIORITY|||||||0.3246|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 192||||0.3246
91524912|NCT05375955|182925303|OTHER||Risk Difference (RD)|30.4||||0.0007|TWO_SIDED|95.0|12.2|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|12.2|0.0007
91524913|NCT05375955|182925303|OTHER||Risk Difference (RD)|21.5||||0.0146|TWO_SIDED|95.0|2.1|41.2|||Chan and Zhang (1999) method|||Week 10||41.2|2.1|0.0146
91524914|NCT05375955|182925303|OTHER||Risk Difference (RD)|19.7||||0.0205|TWO_SIDED|95.0|1.0|38.9|||Chan and Zhang (1999) method|||Week 10||38.9|1.0|0.0205
91621544|NCT01797965|183137108|SUPERIORITY|||||||0.6423|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 216||||0.6423
91621545|NCT01797965|183137108|SUPERIORITY|||||||0.0288|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 240||||0.0288
91621546|NCT01797965|183137109|SUPERIORITY|||||||0.2567|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.2567
91621547|NCT01797965|183137109|SUPERIORITY|||||||0.6152|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.6152
91621548|NCT01797965|183137109|SUPERIORITY|||||||0.2024|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2024
91621549|NCT01797965|183137109|SUPERIORITY|||||||0.9988|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.9988
91621550|NCT01797965|183137109|SUPERIORITY|||||||0.7962|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.7962
91621551|NCT01797965|183137109|SUPERIORITY|||||||0.8486|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8486
91621552|NCT01797965|183137109|SUPERIORITY|||||||0.4478|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.4478
91621553|NCT01797965|183137109|SUPERIORITY|||||||0.325|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.3250
91621554|NCT01797965|183137109|SUPERIORITY|||||||0.129|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.1290
91621555|NCT01797965|183137109|SUPERIORITY|||||||0.7295|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.7295
91621556|NCT01797965|183137109|SUPERIORITY|||||||0.8647|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.8647
91621557|NCT01797965|183137109|SUPERIORITY|||||||0.2183|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.2183
91621558|NCT01797965|183137109|SUPERIORITY|||||||0.3945|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.3945
91621559|NCT01797965|183137109|SUPERIORITY|||||||0.5068|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.5068
91621560|NCT01797965|183137109|SUPERIORITY|||||||0.1669|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.1669
91621561|NCT01797965|183137109|SUPERIORITY|||||||0.5038|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.5038
91621562|NCT01797965|183137109|SUPERIORITY|||||||0.6001|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 303||||0.6001
91660112|NCT00473330|183214952|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|25.1|||<|0.0001|TWO_SIDED|95.0|14.0|36.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||36.3|14.0|<0.0001
91660113|NCT00473330|183214953|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|8.2||||0.0086|TWO_SIDED|95.0|2.4|14.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||14.1|2.4|0.0086
91660114|NCT00473330|183214953|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.8||||0.0126|TWO_SIDED|95.0|2.0|13.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.6|2.0|0.0126
91660115|NCT00473330|183214954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.0005|TWO_SIDED|95.0|4.3|15.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||15.1|4.3|0.0005
91660116|NCT00473330|183214954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2||||0.0011|TWO_SIDED|95.0|3.3|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||13.0|3.3|0.0011
91660117|NCT00473330|183214955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-107.9|||<|0.0001|TWO_SIDED|95.0|-149.2|-66.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-66.6|-149.2|<0.0001
91660118|NCT00473330|183214955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-119.1|||<|0.0001|TWO_SIDED|95.0|-159.6|-78.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-78.5|-159.6|<0.0001
91524915|NCT05375955|182925303|OTHER||Risk Difference (RD)|39.7||||0.0002|TWO_SIDED|95.0|17.1|59.3|||Chan and Zhang (1999) method|||Week 10||59.3|17.1|0.0002
91713430|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.|Wilcoxon test|||||||0.13
91621563|NCT01797965|183137109|SUPERIORITY|||||||0.8617|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 168 for 303||||0.8617
91621564|NCT01797965|183137109|SUPERIORITY|||||||0.259|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 192 for 303||||0.2590
91621565|NCT01797965|183137109|SUPERIORITY|||||||0.5159|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 216 for 303||||0.5159
91621566|NCT01797965|183137109|SUPERIORITY|||||||0.6123|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 240 for 303||||0.6123
91660119|NCT00473330|183214956|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-3.0||||0.159|TWO_SIDED|95.0|-6.7|0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.7|-6.7|0.1590
91660120|NCT00473330|183214956|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-2.5||||0.2721|TWO_SIDED|95.0|-6.5|1.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||1.4|-6.5|0.2721
91660121|NCT00473330|183214957|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|29.5|||<|0.0001|TWO_SIDED|95.0|21.1|38.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||38.0|21.1|<0.0001
91713431|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.|Wilcoxon test|||||||0.06
91524916|NCT05375955|182925303|OTHER||Risk Difference (RD)|12.6||||0.1245|TWO_SIDED|95.0|-7.8|32.6|||Chan and Zhang (1999) method|||Week 12||32.6|-7.8|0.1245
91621567|NCT01764256|183137110|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.44|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event (related or unrelated)||||0.44
91524917|NCT05375955|182925303|OTHER||Risk Difference (RD)|11.0||||0.1431|TWO_SIDED|95.0|-9.1|31.5|||Chan and Zhang (1999) method|||Week 12||31.5|-9.1|0.1431
91621568|NCT01764256|183137110|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.7446|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event: potentially related||||0.7446
91621569|NCT01764256|183137111|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.5694|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.5694
91621570|NCT01764256|183137111|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1.0000
91621571|NCT01764256|183137111|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
91621572|NCT01764256|183137112|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.6004|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.6004
91621573|NCT01764256|183137112|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1
91621574|NCT01764256|183137112|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.00
91660122|NCT00473330|183214957|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.2|||<|0.0001|TWO_SIDED|95.0|16.7|31.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.7|16.7|<0.0001
91660123|NCT00473330|183214958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.4|<0.0001
91660124|NCT00473330|183214958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.5|<0.0001
91660125|NCT00336479|183215019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.985||||0.0014|TWO_SIDED|95.0|1.525|5.842|||Regression, Logistic|Treatment, weight, race and baseline HCV RNA as factors||||5.842|1.525|0.0014
91660126|NCT00336479|183215019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0204|TWO_SIDED|95.0|1.127|4.178|||Regression, Logistic|||||4.178|1.127|0.0204
91660127|NCT00336479|183215020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.586||||0.0051|TWO_SIDED|95.0|1.331|5.025|||Regression, Logistic|||||5.025|1.331|0.0051
91660128|NCT00336479|183215020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.976||||0.0418|TWO_SIDED|95.0|1.026|3.807|||Regression, Logistic|||||3.807|1.026|0.0418
91660129|NCT01265056|183215032|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91660130|NCT01265056|183215032|SUPERIORITY||||||<|0.04|||||||Regression, Logistic|||||||<0.04
91660131|NCT01265056|183215033|SUPERIORITY||||||<|0.8|||||||t-test, 2 sided|||||||<0.8
91660132|NCT01265056|183215034|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91660133|NCT01416584|183215035|SUPERIORITY||Odds Ratio (OR)|1.4||||0.6|TWO_SIDED|95.0|0.4|4.83|||General Estimating Equation (GEE)|||||4.83|0.40|0.60
91660134|NCT01416584|183215035|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED|95.0|0.32|3.73|||General Estimating Equation (GEE)|||||3.73|0.32|0.88
91660135|NCT01416584|183215035|SUPERIORITY||Odds Ratio (OR)|1.27||||0.64|TWO_SIDED|95.0|0.36|4.46|||General Estimating Equation (GEE)|||||4.46|0.36|0.64
91660136|NCT01416584|183215036|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
91660137|NCT01416584|183215036|SUPERIORITY||Odds Ratio (OR)|0.73||||0.39|TWO_SIDED|95.0|0.34|1.57|||General Estimating Equation (GEE)|||||1.57|0.34|0.39
91660138|NCT01416584|183215036|SUPERIORITY||Odds Ratio (OR)|1.86||||0.1|TWO_SIDED|95.0|1.53|2.26|||General Estimating Equation (GEE)|||||2.26|1.53|0.10
91660139|NCT01416584|183215037|SUPERIORITY||Odds Ratio (OR)|0.37||||0.02|TWO_SIDED|95.0|0.36|0.38|||General Estimating Equation (GEE)|||||0.38|0.36|0.02
91660140|NCT01416584|183215037|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
91660141|NCT01416584|183215037|SUPERIORITY||Odds Ratio (OR)|1.07||||0.85|TWO_SIDED|95.0|0.2|5.66|||General Estimating Equation (GEE)|||||5.66|0.20|0.85
91660142|NCT01416584|183215038|SUPERIORITY||Odds Ratio (OR)|0.35||||0.01|TWO_SIDED|95.0|0.34|0.35|||General Estimating Equation (GEE)|||||0.35|0.34|0.01
91660143|NCT01416584|183215038|SUPERIORITY||Odds Ratio (OR)|0.41||||0.03|TWO_SIDED|95.0|0.39|0.44|||General Estimating Equation (GEE)|||||0.44|0.39|0.03
91660144|NCT01416584|183215038|SUPERIORITY||Odds Ratio (OR)|0.84||||0.63|TWO_SIDED|95.0|0.42|1.69|||General Estimating Equation (GEE)|||||1.69|0.42|0.63
91660145|NCT01416584|183215039|SUPERIORITY||Odds Ratio (OR)|0.4||||0.01|TWO_SIDED|95.0|0.39|0.4|||General Estimating Equation (GEE)|||||0.40|0.39|0.01
91660146|NCT01416584|183215039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.37|TWO_SIDED|95.0|0.36|1.55|||General Estimating Equation (GEE)|||||1.55|0.36|0.37
91660147|NCT01416584|183215039|SUPERIORITY||Odds Ratio (OR)|0.53||||0.05|TWO_SIDED|95.0|0.28|1.0|||General Estimating Equation (GEE)|||||1.00|0.28|0.05
91660148|NCT02612337|183215074|SUPERIORITY|The target sample size for each was 160 randomized subjects: 80 in each treatment group stratified by gender. The sample size estimate was chosen to achieve more than 90% power with a significance level of 0.05 2-sided to reject the null hypothesis of no treatment difference for the primary endpoint of DVD.|Risk Ratio (RR)|0.907||||0.623|TWO_SIDED|95.0|0.615|1.339|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||1.339|0.615|0.623
91621575|NCT01764256|183137113|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
91621576|NCT01764256|183137113|EQUIVALENCE|Equivalence defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
91660149|NCT03616106|183215089|OTHER||Slope|-15.103||||0.859|TWO_SIDED|95.0|-184.574|154.369||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||154.369|-184.574|0.859
91660150|NCT03616106|183215090|OTHER||Slope|28.243||||0.213|TWO_SIDED|95.0|-16.694|73.179||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||73.179|-16.694|0.213
91660151|NCT03616106|183215091|OTHER||Slope|58.993||||0.031|TWO_SIDED|95.0|5.713|112.274||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||112.274|5.713|0.031
91621577|NCT01764256|183137113|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
91621578|NCT01764256|183137114|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
91621579|NCT01764256|183137114|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
91660152|NCT03616106|183215092|OTHER||Slope|-0.0651||||0.053|TWO_SIDED|95.0|-1.313|0.01||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||Viral load variables were log transformed for regression analyses.||0.010|-1.313|0.053
91660153|NCT03616106|183215093|OTHER||Slope|-1.601||||0.008|TWO_SIDED|95.0|-2.761|-0.442||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-0.442|-2.761|0.008
91660154|NCT03616106|183215094|OTHER||Slope|-2.674||||0|TWO_SIDED|95.0|-3.934|-1.415||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-1.415|-3.934|0.000
91660155|NCT03616106|183215108|OTHER||Slope|2.172||||0|TWO_SIDED|95.0|1.448|2.895||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||2.895|1.448|0.000
91660156|NCT03616106|183215109|OTHER||Slope|2.872||||0|TWO_SIDED|95.0|2.1|3.643||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.643|2.100|0.000
91621580|NCT01764256|183137114|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
91621581|NCT00304915|183137119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.003|TWO_SIDED|95.0|1.37|4.56|||Regression, Logistic|||||4.56|1.37|0.003
91621582|NCT00973921|183137185|SUPERIORITY_OR_OTHER||Proportion|1.0|||<|0.01|TWO_SIDED|95.0|0.86|1.0|||Wilson|||The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportion||1.0|0.86|<0.01
91621583|NCT00973921|183137186|SUPERIORITY_OR_OTHER||Correlation coefficient|0.74|||<|0.0001|||||||Bland Altman|||||||<0.0001
91621584|NCT00973921|183137188|SUPERIORITY_OR_OTHER||Correlation coefficient|0.5||||0.0034|||||||Bland-Altman|||||||0.0034
91621585|NCT00230100|183137199|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
91621586|NCT00230100|183137200|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
91621587|NCT00230100|183137201|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
91621588|NCT00230100|183137202|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||It was hypothesized that the single-gender group composition and women-focused group content (WRG) would result in better substance abuse treatment outcomes (lower ASI alcohol composite scores) than standard mixed-gender group treatment (GDC).||||<0.05
91621589|NCT00230100|183137203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.009|||||||Mixed Models Analysis|||||||<0.009
91621590|NCT04348591|183137210|SUPERIORITY||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.037||0.221|TWO_SIDED|95.0|-0.12|0.029||This p value corresponds to the main effect for experimental group; a-priori threshold was .012|Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined main effects of experimental group, instruction provided, headache, racial background, and type of neurostimulation administered. HF-HRV was transformed using an lg function for normality.||.029|-.12|.221
91621591|NCT04348591|183137210|SUPERIORITY|This is a within subject analysis that uses data across groups, controlling for the effect of neurostimulation alone, coil to cortex distance, and racial background|Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.008|TWO_SIDED|95.0|0.016|0.103|||Mixed Models Analysis|Comparison between sham neurostimulation and high frequency neurostimulation||A MMANOVA analysis using an unstructured covariance examined the main effect of type of neurostimulation provided||.103|.016|.008
91621592|NCT04348591|183137210|SUPERIORITY|The analysis controls for coil to cortex distance, racial background and effect of neurostimulation alone. It compares sham stimulation with low frequency neurostimulation|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.021||0.001|TWO_SIDED|95.0|0.029|0.111|||Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined the main effect of type of neurostimulation provided.||.111|.029|.001
91621593|NCT04348591|183137211|SUPERIORITY||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.232||0.34|TWO_SIDED|95.0|-0.243|0.689|||Mixed Models Analysis||This is the result for the main effect found of group (emotion dysregulation group versus misophonia)|A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.689|-.243|.34
91660157|NCT03616106|183215110|OTHER||Slope|3.166||||0|TWO_SIDED|95.0|2.487|3.846||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.846|2.487|0.000
91621594|NCT04348591|183137211|SUPERIORITY||Mean Difference (Final Values)|0.493|STANDARD_ERROR_OF_MEAN|0.148||0.001|TWO_SIDED|95.0|0.198|0.787|||Mixed Models Analysis|This is the main effect of neurostimulation condition. Specifically here we show the difference in estimated marginal means between sham and HF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.787|.198|.001
91660158|NCT03616106|183215111|OTHER||Z Score|3.25||||0.0011|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0011
91524918|NCT05375955|182925303|OTHER||Risk Difference (RD)|36.8||||0.0007|TWO_SIDED|95.0|12.2|56.8|||Chan and Zhang (1999) method|||Week 12||56.8|12.2|0.0007
91621595|NCT04348591|183137211|SUPERIORITY||Mean Difference (Final Values)|0.469|STANDARD_ERROR_OF_MEAN|0.144||0.002|TWO_SIDED|95.0|0.182|0.757|||Mixed Models Analysis|This is the main effect of neurostimulation administered, specifically comparing estimated marginal means for sham and LF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.757|.182|.002
91660159|NCT03616106|183215112|OTHER||Z score|3.94||||0.0001|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0001
91660160|NCT03616106|183215113|OTHER||Z score|4.12||||0|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.000
91660161|NCT03616106|183215114|OTHER||Slope|1.935||||0|TWO_SIDED|95.0|1.055|2.815||This p-value was not adjusted for multiple comparisons. The p-value threshold for statistical significance was, therefore, 0.05|Regression, Linear|||||2.815|1.055|0.000
91722454|NCT01932606|183337703|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean blood pressure.||||0.2
91524919|NCT05375955|182925304|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
91524920|NCT05375955|182925304|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
91524921|NCT05375955|182925304|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
91660162|NCT03616106|183215115|OTHER||Slope|2.123||||0|TWO_SIDED|95.0|1.184|3.062||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.062|1.184|0.000
91660163|NCT03616106|183215116|OTHER||Slope|2.552||||0|TWO_SIDED|95.0|1.612|3.492||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.492|1.612|0.000
91660164|NCT03616106|183215117|OTHER||Z score|-1.57||||0.1167|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.1167
91524922|NCT05375955|182925304|OTHER||Risk Difference (RD)|7.3||||0.1118|TWO_SIDED|95.0|-3.9|20.5|||Chan and Zhang (1999) method|||Week 2||20.5|-3.9|0.1118
91524923|NCT05375955|182925304|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 4||20.5|-9.5|0.2751
91660165|NCT03616106|183215118|OTHER||Z score|-2.91||||0.0036|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0036
91660166|NCT03616106|183215119|OTHER||Z score|-3.54||||0.0004|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0004
91660167|NCT02779543|183215127|EQUIVALENCE|this trial compared the 2 devices to the polysomnography, which is the gold standard|Mean value|368.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
91660168|NCT02779543|183215128|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|13.9|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
91660169|NCT02779543|183215129|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|106.0|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
91621596|NCT04348591|183137211|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.0005|TWO_SIDED||||||Mixed Models Analysis||mean difference between sham and HF-rTMS for misophonia participants only when downregulating misophonic sounds|The investigators tested the interaction between experimental neurostimulation (sham, active high frequency rTMS, active low frequency rTMS), instruction provided (listen to neutral sound; listen to aversive sound, listen to misophonic sound, downregulate aversive sound, downregulate misophonic sound), and group (misophonic, clinical control) as part of the same MMANOVA analysis described above (i.e., controlling for coil-to-cortex distance, racial background, baseline, \& presence of headache).||||.0005
91524924|NCT05375955|182925304|OTHER||Risk Difference (RD)|2.8||||0.3857|TWO_SIDED|95.0|-11.4|17.6|||Chan and Zhang (1999) method|||Week 4||17.6|-11.4|0.3857
91524925|NCT05375955|182925304|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
91621597|NCT04348591|183137213|SUPERIORITY||Mean Difference (Final Values)|0.0563|STANDARD_ERROR_OF_MEAN|0.09853||0.57|TWO_SIDED|95.0|-0.14149|0.25411|||t-test, 2 sided|||An independent samples t-test was conducted to examine differences between groups in BOLD bilateral dlPFC signal during the regulation of misophonic versus aversive sounds. One outlier was removed from the misophonia group to avoid violating the normality assumption.||.25411|-.14149|.57
91621598|NCT04348591|183137214|SUPERIORITY||Mean Difference (Final Values)|0.037293|STANDARD_ERROR_OF_MEAN|0.131419||0.778|TWO_SIDED|95.0|-0.22667|0.301257|||t-test, 2 sided|50 degrees of freedom||An independent samples t-test was conducted to examine differences between groups in vmPFC activation that was greater when downregulating misophonic versus non-misophonic distress. One participant from each group was excluded for being an outlier||0.301257|-0.226670|.778
91621599|NCT04348591|183137215|SUPERIORITY||z score|4.69|||<|0.05|TWO_SIDED||||||mixed effects whole-brain using cluster|||Mixed effects (FSL's FLAME 1; Oxford Univ., UK) whole brain analyses using cluster correction following a voxel-wise Z-score threshold of 2.3.||||<.05
91621600|NCT04348591|183137216|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.283||0.49|TWO_SIDED|95.0|-0.766|0.372|||Mixed Models Analysis|This is the main effect from the MMANOVA analysis for group difference.||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.372|-.766|.49
91524926|NCT05375955|182925304|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
91524927|NCT05375955|182925304|OTHER||Risk Difference (RD)|9.8||||0.1119|TWO_SIDED|95.0|-4.4|25.3|||Chan and Zhang (1999) method|||Week 8||25.3|-4.4|0.1119
91524928|NCT05375955|182925304|OTHER||Risk Difference (RD)|2.7||||0.3755|TWO_SIDED|95.0|-10.7|16.7|||Chan and Zhang (1999) method|||Week 8||16.7|-10.7|0.3755
91524929|NCT05375955|182925304|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-8.4|0.2547
91621601|NCT04348591|183137216|SUPERIORITY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|0.147|<|1e-07|TWO_SIDED|95.0|0.62|1.97||This p-value corresponds to the difference between sham and HF-rTMS stimulation|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||1.97|.62|<.0000001
91621602|NCT04348591|183137216|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|0.057|0.605||The test corresponds to the difference between sham and LF-rTMS|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.605|.057|.018
91621603|NCT04348591|183137216|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|1e-06|TWO_SIDED||||||Mixed Models Analysis||For participants with misophonia difference in distress produced by a misophonic sound when downregulating misophonic sounds while receiving sham vs.HF-rTMS|The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the interaction effect of group by neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||||<.000001
91621604|NCT04348591|183137217|SUPERIORITY||Mean Difference (Final Values)|9.53|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|||||This is the result corresponding to the main effect of time in the repeated measures ANCOVA|ANCOVA|||Repeated measures ANOVA (controlling for racial background)||||<.001
91621605|NCT04348591|183137217|SUPERIORITY||||||>|0.012|||||||ANCOVA|This analysis corresponds to the main effect of group.||Repeated measures ANOVA (controlling for racial background)||||>.012
91660170|NCT02779543|183215130|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|74.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
91621606|NCT04348591|183137218|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Anxiety subscale||||.78
91621607|NCT04348591|183137218|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Depression subscale||||.29
91621608|NCT04348591|183137218|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Fatigue subscale||||.64
91621609|NCT04348591|183137218|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Sleep disturbance subscale||||.16
91621610|NCT04348591|183137218|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Ability to partake in social roles subscale||||.56
91621611|NCT00186056|183137248|SUPERIORITY_OR_OTHER||||||<|0.26|||||||ANOVA|Interaction of HAMD \* medication group F(2,26)=1.38, eta sq = .05||||||<.26
91524930|NCT05375955|182925304|OTHER||Risk Difference (RD)|2.9||||0.3928|TWO_SIDED|95.0|-12.7|18.6|||Chan and Zhang (1999) method|||Week 10||18.6|-12.7|0.3928
91621612|NCT00302718|183137314|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91621613|NCT00302718|183137316|OTHER|||||||0.2114|||||||Chi-squared|||||||0.2114
91621614|NCT00302718|183137318|OTHER|||||||0.6954|||||||Chi-squared|||||||0.6954
91621615|NCT00302718|183137320|OTHER|||||||0.9895|||||||Chi-squared|||||||0.9895
91621616|NCT00738374|183137321|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Chi-squared|||Analysis compared responders and non-responders.||||0.0008
91621617|NCT00738374|183137322|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Chi-squared|||||||0.0795
91660171|NCT00939003|183215145|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91660172|NCT00939003|183215146|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
91660173|NCT00939003|183215147|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
91660174|NCT00939003|183215148|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
91621618|NCT00738374|183137338|SUPERIORITY_OR_OTHER|||||||0.2712|TWO_SIDED||||||Log Rank|||||||0.2712
91621619|NCT02300077|183137397|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
91621620|NCT02300077|183137398|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91621621|NCT02300077|183137399|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91621622|NCT02300077|183137400|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
91621623|NCT00077376|183137401|SUPERIORITY_OR_OTHER||Objective response rate|41.0|||||TWO_SIDED|95.0|26.0|58.0||||||||58|26|
91621624|NCT00077376|183137402|SUPERIORITY_OR_OTHER||Objective response rate|44.0|||||TWO_SIDED|95.0|31.0|58.0||||||||58|31|
91621625|NCT05757427|183137409|OTHER|"The sample size is calculated solely for the first primary endpoint, no minimal number of benign nor malignant lesions was set.~The sample size is calculated for this trial design, assuming a p1 = 75% and p0 = 60% for power (1-beta) of 80%, and an alpha level of 5%.~We will conclude that the Wavelia # 2 Microwave Breast Imaging system is effective in detecting breast lesions if more than 43 of the 62 subjects' lesions are detected."|Proportion of detected lesions|90.32|||||TWO_SIDED|95.0|80.45|95.49||||||||95.49|80.45|
91621626|NCT05757427|183137411|OTHER|The percentage of malignant and benign breast lesions correctly detected by Wavelia MWBI on patients that did not have a biopsy clip marking the lesion position in the breast, will be presented with 95% confidence interval.|Proportion of detected lesions|88.24|||||TWO_SIDED|95.0|65.66|96.71||||||||96.71|65.66|
91621627|NCT05757427|183137412|OTHER||Proportion of patients with AEs|5.48|||||TWO_SIDED|||||||||||||
91621628|NCT02528253|183137516|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1117|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||0.07|-0.66|0.1117
91621629|NCT02528253|183137516|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0281|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||-0.04|-0.76|0.0281
91621630|NCT02528253|183137517|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
91660175|NCT00939003|183215149|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Chi-squared|||||||0.014
91621631|NCT02528253|183137517|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
91621632|NCT02528253|183137518|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.3118|TWO_SIDED|95.0|-0.5|0.16|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.50|0.3118
91660176|NCT00939003|183215152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91621633|NCT02528253|183137518|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.0958|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.05|-0.60|0.0958
91621634|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12||0.0015|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.14|-0.60|0.0015
91621635|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0004|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.19|-0.65|0.0004
91621636|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0959|TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.03|-0.39|0.0959
91621637|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.01|-0.44|0.0370
91660177|NCT00939003|183215153|SUPERIORITY_OR_OTHER|||||||0.027|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.027
91660178|NCT00939003|183215154|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||<0.001
91660179|NCT00939003|183215155|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.003
91660180|NCT00939003|183215156|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
91660181|NCT03707912|183215184|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91660182|NCT03707912|183215185|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91660183|NCT03707912|183215186|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
91660184|NCT03707912|183215186|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.98|||||||Breslow-Day test|||||||0.98
91660185|NCT03707912|183215187|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91621638|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.20|-0.76|0.0008
91621639|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.39|-0.96|<.0001
91621640|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0711|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0711
91621641|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0661|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0661
91621642|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.13||0.0009|TWO_SIDED|95.0|-0.7|-0.18|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.18|-0.70|0.0009
91621643|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.16||0.0008|TWO_SIDED|95.0|-0.84|-0.22|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.22|-0.84|0.0008
91621644|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.38|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.38|-1.00|<.0001
91621645|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.15||0.0274|TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.04|-0.61|0.0274
91621646|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.15||0.1495|TWO_SIDED|95.0|-0.5|0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.08|-0.50|0.1495
91713432|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.|Wilcoxon test|||||||0.13
91621647|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0123|TWO_SIDED|95.0|-0.65|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-0.65|0.0123
91621648|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0307|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-0.71|0.0307
91621649|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0009|TWO_SIDED|95.0|-0.91|-0.24|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.24|-0.91|0.0009
91621650|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2103|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.11|-0.51|0.2103
91722455|NCT01932606|183337704|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR.||||0.7
91722456|NCT01932606|183337705|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery compliance.||||0.1
91621651|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.2656|TWO_SIDED|95.0|-0.48|0.13|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.48|0.2656
91621652|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0152|TWO_SIDED|95.0|-0.68|-0.07|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.68|0.0152
91621653|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19||0.5164|TWO_SIDED|95.0|-0.5|0.25|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.25|-0.50|0.5164
91621654|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.1488|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.10|-0.66|0.1488
91621655|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.2431|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.60|0.2431
91621656|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2428|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.62|0.2428
91621657|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4561|TWO_SIDED|95.0|-0.54|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.24|-0.54|0.4561
91621658|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3523|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.20|-0.56|0.3523
91621659|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4403|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.23|-0.53|0.4403
91621660|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3205|TWO_SIDED|95.0|-0.58|0.19|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.19|-0.58|0.3205
91621661|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5763|TWO_SIDED|95.0|-0.51|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.28|-0.51|0.5763
91621662|NCT02528253|183137519|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2887|TWO_SIDED|95.0|-0.61|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.18|-0.61|0.2887
91621663|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.34||0.0121|TWO_SIDED|95.0|-1.5|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-1.50|0.0121
91621664|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.05|-0.71|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.71|-2.05|<.0001
91660186|NCT03707912|183215188|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91660187|NCT03707912|183215188|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.75|||||||Breslow-Day test|||||||0.75
91524931|NCT05375955|182925305|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
91660188|NCT03707912|183215189|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Day 1 comparison.||||0.89
91660189|NCT03707912|183215189|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Day 2 comparison.||||0.75
91660190|NCT03707912|183215189|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 3 comparison.||||0.34
91660191|NCT03707912|183215190|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
91722457|NCT01932606|183337706|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR.||||0.3
91722458|NCT01932606|183337707|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW.||||0.3
91621665|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.3697|TWO_SIDED|95.0|-0.89|0.33|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.33|-0.89|0.3697
91621666|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0658|TWO_SIDED|95.0|-1.16|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-1.16|0.0658
91660192|NCT02934347|183215191|SUPERIORITY_OR_OTHER||||||>|0.05||||||Grades analysed were 1, 2 and then 3 and 4 combined because of low frequencies in the latter two grades|Chi-squared, Corrected|Chi-squared for trend||Null hypothesis: no difference in frequency of grade of glottic view between the supine and back-up positions||||>0.05
91660193|NCT02934347|183215192|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|df=3||||||<0.01
91660194|NCT02934347|183215193|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91621667|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.50|-1.70|0.0004
91621668|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.38||0.0013|TWO_SIDED|95.0|-1.96|-0.48|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.48|-1.96|0.0013
91621669|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.7|-1.21|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.21|-2.70|<.0001
91660195|NCT02934347|183215194|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91660196|NCT03235739|183215208|SUPERIORITY|multiple imputation for longitudinal data was conducted to impute the missing data for the primary outcome. The final results were obtained from pooling results from 10 imputed complete case data set.|geometric mean ratio|0.9||||0.84|TWO_SIDED|95.0|0.32|2.55|||Mixed Models Analysis|||||2.55|0.32|0.84
91660197|NCT03235739|183215208|SUPERIORITY|A sensitivity analysis using complete case analysis|geometric mean ratio|0.82||||0.73|TWO_SIDED|95.0|0.26|2.56|||Mixed Models Analysis|||||2.56|0.26|0.73
91660198|NCT03235739|183215209|SUPERIORITY||geometric mean ratio|1.02||||0.91|TWO_SIDED|98.3|0.63|1.67|||Mixed Models Analysis|||||1.67|0.63|0.91
91660199|NCT03235739|183215210|SUPERIORITY||Risk Ratio (RR)|2.58||||0.012|TWO_SIDED|98.3|0.98|6.8|||Chi-squared|||||6.80|0.98|0.012
91660200|NCT03235739|183215211|SUPERIORITY||median of differences|-5.0||||0.08|TWO_SIDED|98.3|-12.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-12|0.08
91660201|NCT02847650|183215212|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.26||0.0407|TWO_SIDED|90.0|-8.6|-1.0|||Mixed Models Analysis|||||-1.0|-8.6|0.0407
91660202|NCT00467896|183215236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.8|||<|0.0001|TWO_SIDED|95.0|39.55|60.15|||t-test, 2 sided|||Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)||60.15|39.55|<0.0001
91660203|NCT03818581|183215241|SUPERIORITY|||||||0.15|||||||SPCD analysis|||||||0.15
91713433|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3741||||||The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3741
91791878|NCT00329901|183461314|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0||||||Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||1|-12|
91660204|NCT00355797|183215244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.17|STANDARD_DEVIATION|15.9||0.004|TWO_SIDED|95.0|3.24|15.11|||t-test, 2 sided|||The endpoint will compare the composite percent change in ADL performance for patients while their devices are programmed to CLS and accelerometer pacing modes, using the no rate adaptive pacing mode as the baseline. Null hypothesis: mean composite of percent change for patients with their device programmed to CLS is less than or equal to the mean composite of percent change for the same patients with their device in accelerometer.||15.11|3.24|0.004
91621670|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3906|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.39|-0.99|0.3906
91660205|NCT00355797|183215251|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.42|STANDARD_DEVIATION|17.74||0.552|TWO_SIDED|95.0|-6.17|3.33|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device in accelerometer.||3.33|-6.17|0.552
91660206|NCT00355797|183215251|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.91|STANDARD_DEVIATION|21.34||0.505|TWO_SIDED|95.0|-3.8|7.63|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device without rate adaptative pacing.||7.63|-3.80|0.505
91524932|NCT05375955|182925305|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
91621671|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.35||0.0082|TWO_SIDED|95.0|-1.6|-0.24|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-1.60|0.0082
91524933|NCT05375955|182925305|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
91713434|NCT01519817|183318383|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
91713435|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.|Wilcoxon test|||||||0.13
91722459|NCT01932606|183337708|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in VO\_2.||||0.8
91621672|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.34|-0.97|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.97|-2.34|<.0001
91660207|NCT02262377|183215266|SUPERIORITY|The ITT analysis was done for 21 week average pain.|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.92|1.15||Statistical significance was set at p\< 0.05.|Regression, Poisson|||Intention to Treat Analysis for average chronic pain.||1.15|0.92|0.68
91660208|NCT02262377|183215266|SUPERIORITY|The ITT analysis was done for 21 week BPI Interference.|Risk Ratio (RR)|0.98||||0.36|TWO_SIDED|95.0|0.88|1.08||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.08|0.88|0.36
91660209|NCT02262377|183215266|SUPERIORITY|The ITT analysis was done for 21 week BPI Severity.|Risk Ratio (RR)|1.0||||0.996|TWO_SIDED|95.0|0.86|1.16||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.16|0.86|0.996
91660210|NCT02262377|183215267|SUPERIORITY||Risk Ratio (RR)|1.17||||0.054|TWO_SIDED|95.0|0.99|1.37|||Regression, Poisson|||||1.37|0.99|0.054
91524934|NCT05375955|182925305|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
91524935|NCT05375955|182925305|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
91621673|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.4||0.0006|TWO_SIDED|95.0|-2.15|-0.58|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.58|-2.15|0.0006
91524936|NCT05375955|182925305|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
91524937|NCT05375955|182925305|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
91524938|NCT05375955|182925305|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
91660211|NCT02262377|183215268|SUPERIORITY||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.89|1.13|||Regression, Poisson|||||1.13|0.89|0.98
91524939|NCT05375955|182925305|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
91524940|NCT05375955|182925305|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
91660212|NCT02262377|183215269|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.18|0.98|||Odds Ratio|||||0.98|0.18|
91660213|NCT02262377|183215270|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.9|1.14|||Odds Ratio|||||1.14|0.90|
91660214|NCT01591785|183215276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
91660215|NCT01591785|183215277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Chi-squared|||||||0.28
91660216|NCT01591785|183215278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0495|TWO_SIDED||||||Chi-squared|||||||0.0495
91660217|NCT01591785|183215279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
91660218|NCT01049334|183215280|SUPERIORITY_OR_OTHER||least-square means difference|-151.5||||0.0201|TWO_SIDED|95.0|-278.9|-24.0||The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.|ANOVA|Treatment as a fixed effect and baseline STPIS as a covariate.||||-24.0|-278.9|0.0201
91660219|NCT01049334|183215281|SUPERIORITY_OR_OTHER||least-square means difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-29.2|-9.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-9.9|-29.2|<.0001
91660220|NCT01049334|183215282|SUPERIORITY_OR_OTHER||least-square means difference|-22.3|||<|0.0001|TWO_SIDED|95.0|-31.7|-12.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-12.9|-31.7|<0.0001
91660221|NCT01049334|183215283|SUPERIORITY_OR_OTHER||least-square means difference|-181.7||||0.0071|TWO_SIDED|95.0|-313.7|-50.0||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-50.0|-313.7|0.0071
91660222|NCT01049334|183215284|SUPERIORITY_OR_OTHER||least-square means difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-30.2|-11.2||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-11.2|-30.2|<0.0001
91713436|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.|Wilcoxon test|||||||>0.9999
91660223|NCT01049334|183215285|SUPERIORITY_OR_OTHER||least-square means difference|-137.6||||0.0393|TWO_SIDED|95.0|-268.5|-6.8||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-6.8|-268.5|0.0393
91660224|NCT01049334|183215286|SUPERIORITY_OR_OTHER|||||||0.0459||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0459
91660225|NCT01049334|183215287|SUPERIORITY_OR_OTHER|||||||0.8383||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.8383
91660226|NCT01049334|183215288|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
91660227|NCT01049334|183215289|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
91660228|NCT01049334|183215290|SUPERIORITY_OR_OTHER|||||||0.0002||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0002
91660229|NCT01049334|183215291|SUPERIORITY_OR_OTHER||least-square means difference|-156.3||||0.0435|TWO_SIDED|95.0|-307.9|-4.6||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|||||-4.6|-307.9|0.0435
91660230|NCT01049334|183215292|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||<.0001
91660231|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1448|TWO_SIDED|95.0|0.0|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 2||0.1|-0.0|0.1448
91660232|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1538|TWO_SIDED|95.0|0.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 4||0.3|-0.0|0.1538
91660233|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.1407|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 6||0.5|-0.1|0.1407
91660234|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.2906|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 8||0.7|-0.2|0.2906
91660235|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.4758|TWO_SIDED|95.0|-0.4|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 10||0.8|-0.4|0.4758
91660236|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.6975|TWO_SIDED|95.0|-0.6|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 12||0.9|-0.6|0.6975
91660237|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|0.0||||0.937|TWO_SIDED|95.0|-0.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 14||0.9|-0.8|0.9370
91660238|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.8493|TWO_SIDED|95.0|-1.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 16||0.9|-1.1|0.8493
91660239|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-0.3||||0.6732|TWO_SIDED|95.0|-1.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 18||0.9|-1.4|0.6732
91660240|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-0.4||||0.5414|TWO_SIDED|95.0|-1.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 20||0.9|-1.8|0.5414
91660241|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-0.6||||0.4313|TWO_SIDED|95.0|-2.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 22||0.9|-2.1|0.4313
91660242|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-0.8||||0.3501|TWO_SIDED|95.0|-2.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 24||0.9|-2.4|0.3501
91660243|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-1.0||||0.2679|TWO_SIDED|95.0|-2.8|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 26||0.8|-2.8|0.2679
91660244|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-1.2||||0.2137|TWO_SIDED|95.0|-3.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 28||0.7|-3.2|0.2137
91722460|NCT01932606|183337709|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for arteriovenous oxygen content difference.||||0.1
91524941|NCT05375955|182925305|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
91621674|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.73|-1.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.16|-2.73|<.0001
91621675|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.37||0.0385|TWO_SIDED|95.0|-1.47|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-1.47|0.0385
91621676|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.06|-0.61|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.61|-2.06|0.0003
91660245|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-1.5||||0.1715|TWO_SIDED|95.0|-3.6|0.6|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 30||0.6|-3.6|0.1715
91660246|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-1.8||||0.134|TWO_SIDED|95.0|-4.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 32||0.5|-4.1|0.1340
91713437|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3386||||||The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3386
91660247|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-2.0||||0.103|TWO_SIDED|95.0|-4.5|0.4|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 34||0.4|-4.5|0.1030
91660248|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-2.4||||0.0788|TWO_SIDED|95.0|-5.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 36||0.3|-5.0|0.0788
91621677|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
91660249|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-2.7||||0.062|TWO_SIDED|95.0|-5.5|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 38||0.1|-5.5|0.0620
91660250|NCT01049334|183215293|SUPERIORITY_OR_OTHER||least-square means difference|-3.0||||0.0476|TWO_SIDED|95.0|-6.0|0.0|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 40||-0.0|-6.0|0.0476
91660251|NCT01049334|183215294|SUPERIORITY_OR_OTHER|||||||0.0273||95.0|||||Log Rank|||||||0.0273
91660252|NCT01049334|183215295|SUPERIORITY_OR_OTHER|||||||0.0098||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0098
91524942|NCT05375955|182925305|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
91621678|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
91621679|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.42||0.5412|TWO_SIDED|95.0|-1.09|0.57|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.57|-1.09|0.5412
91660253|NCT02393417|183215312|SUPERIORITY||Risk Ratio (RR)|1.5706||||0.0329|TWO_SIDED|95.0|1.0184|2.4223|||Cochran-Mantel-Haenszel|||||2.4223|1.0184|0.0329
91660254|NCT02393417|183215312|SUPERIORITY||Risk Ratio (RR)|1.8926||||0.0007|TWO_SIDED|95.0|1.2722|2.8156|||Cochran-Mantel-Haenszel|||||2.8156|1.2722|0.0007
91660255|NCT02393417|183215312|SUPERIORITY||Risk Ratio (RR)|1.7319||||0.0052|TWO_SIDED|95.0|1.1602|2.5854|||Cochran-Mantel-Haenszel|||||2.5854|1.1602|0.0052
91660256|NCT02393417|183215313|SUPERIORITY||Risk Ratio (RR)|1.3828||||0.4307|TWO_SIDED|95.0|0.6191|3.0883|||Cochran-Mantel-Haenszel|||||3.0883|0.6191|0.4307
91660257|NCT02393417|183215313|SUPERIORITY||Risk Ratio (RR)|2.8908||||0.0014|TWO_SIDED|95.0|1.4169|5.8978|||Cochran-Mantel-Haenszel|||||5.8978|1.4169|0.0014
91660258|NCT02393417|183215313|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0451|TWO_SIDED|95.0|0.9281|9.6975|||Cochran-Mantel-Haenszel|||||9.6975|0.9281|0.0451
91660259|NCT02393417|183215315|SUPERIORITY||Cox Proportional Hazard|2.7553||||0.0027|TWO_SIDED|95.0|1.4211|5.3419|||Regression, Cox|||||5.3419|1.4211|0.0027
91722461|NCT01932606|183337710|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output.||||0.4
91621680|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.42||0.0107|TWO_SIDED|95.0|-1.87|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.87|0.0107
91621681|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.29|-0.66|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.66|-2.29|0.0004
91621682|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.49||0.0464|TWO_SIDED|95.0|-1.94|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-1.94|0.0464
91621683|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.49||0.0068|TWO_SIDED|95.0|-2.3|-0.37|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.37|-2.30|0.0068
91621684|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.5||0.1485|TWO_SIDED|95.0|-1.7|0.26|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-1.70|0.1485
91621685|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0507|TWO_SIDED|95.0|-1.94|0.0|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-1.94|0.0507
91621686|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.51||0.248|TWO_SIDED|95.0|-1.6|0.41|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.41|-1.60|0.2480
91660260|NCT02393417|183215315|SUPERIORITY||Cox Proportional Hazard|3.1516||||0.0008|TWO_SIDED|95.0|1.6148|6.1509|||Regression, Cox|||||6.1509|1.6148|0.0008
91660261|NCT02393417|183215315|SUPERIORITY||Cox Proportional Hazard|3.3257||||0.0003|TWO_SIDED|95.0|1.7263|6.407|||Regression, Cox|||||6.4070|1.7263|0.0003
91660262|NCT02393417|183215321|SUPERIORITY||Odds Ratio (OR)|0.999||||0.4824|TWO_SIDED|95.0|0.997|1.001|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.001|0.997|0.4824
91621687|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.51||0.1605|TWO_SIDED|95.0|-1.71|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-1.71|0.1605
91621688|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.3654|TWO_SIDED|95.0|-1.5|0.55|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.55|-1.50|0.3654
91621689|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1782|TWO_SIDED|95.0|-1.71|0.32|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.32|-1.71|0.1782
91621690|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.3981|TWO_SIDED|95.0|-1.47|0.58|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.58|-1.47|0.3981
91621691|NCT02528253|183137521|SUPERIORITY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1089|TWO_SIDED|95.0|-1.84|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-1.84|0.1089
91621692|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1472|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1472
91621693|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.0135|TWO_SIDED|95.0|-0.24|-0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.24|0.0135
91621694|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.0893|TWO_SIDED|95.0|-0.18|0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.18|0.0893
91621695|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0044|TWO_SIDED|95.0|-0.23|-0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.23|0.0044
91621696|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.28|0.0025
91621697|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.32|0.0002
91621698|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8348|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.11|0.8348
91713438|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.|Wilcoxon test|||||||0.88
91713439|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0215||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.|Wilcoxon test|||||||0.0215
91524943|NCT05375955|182925305|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
91621699|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.26|0.0020
91621700|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.30|0.0001
91621701|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0272|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0272
91621702|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0009|TWO_SIDED|95.0|-0.31|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.31|0.0009
91621703|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1680
91660263|NCT02393417|183215321|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5007|TWO_SIDED|95.0|0.998|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.998|0.5007
91660264|NCT02393417|183215321|SUPERIORITY||Odds Ratio (OR)|0.993||||0.0219|TWO_SIDED|95.0|0.987|0.999|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||0.999|0.987|0.0219
91660265|NCT02393417|183215321|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8267|TWO_SIDED|95.0|0.995|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.995|0.8267
91660266|NCT02393417|183215322|SUPERIORITY||Odds Ratio (OR)|0.964||||0.1657|TWO_SIDED|95.0|0.915|1.015|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.015|0.915|0.1657
91660267|NCT02393417|183215322|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8168|TWO_SIDED|95.0|0.997|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.997|0.8168
91660268|NCT02393417|183215322|SUPERIORITY||Odds Ratio (OR)|0.998||||0.4183|TWO_SIDED|95.0|0.993|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.993|0.4183
91660269|NCT02393417|183215322|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5572|TWO_SIDED|95.0|0.997|1.006|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.006|0.997|0.5572
91660270|NCT02246166|183215340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9473|TWO_SIDED|95.0|-0.77|0.83|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||0.83|-0.77|0.9473
91660271|NCT02246166|183215341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.721|TWO_SIDED|95.0|-1.23|0.86|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme|||0.86|-1.23|0.7210
91660272|NCT02246166|183215342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.7445|TWO_SIDED|95.0|-1.07|1.49|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.||||1.49|-1.07|0.7445
91660273|NCT02246166|183215343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.7662|TWO_SIDED|95.0|-1.32|1.78|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate||||1.78|-1.32|0.7662
91660274|NCT02246166|183215344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.5208|TWO_SIDED|95.0|-1.18|2.29|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||2.29|-1.18|0.5208
91713440|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.|Wilcoxon test|||||||0.65
91713441|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5076||||||The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5076
91660275|NCT02246166|183215345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8993|TWO_SIDED|95.0|-1.71|1.94|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||1.94|-1.71|0.8993
91660276|NCT05025345|183215392|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.013|||||TWO_SIDED|90.0|-0.036|0.011||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||0.011|-0.036|
91660277|NCT05025345|183215393|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91660278|NCT00984022|183215406|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Fisher Exact|||The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.||||.0003
91713442|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.|Wilcoxon test|||||||0.63
91621704|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2968|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.16|0.2968
91621705|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0219|TWO_SIDED|95.0|-0.23|-0.02|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.23|0.0219
91621706|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0717|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.25|0.0717
91621707|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0207|TWO_SIDED|95.0|-0.29|-0.02|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.29|0.0207
91621708|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8399|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.11|0.8399
91621709|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0299|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0299
91621710|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.29|0.0060
91621711|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1974|TWO_SIDED|95.0|-0.24|0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.24|0.1974
91621712|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.278|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.22|0.2780
91621713|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.433|TWO_SIDED|95.0|-0.21|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.21|0.4330
91713443|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.68||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.|Wilcoxon test|||||||0.68
91713444|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.73||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.|Wilcoxon test|||||||0.73
91524944|NCT05375955|182925305|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
91621714|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4946|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.20|0.4946
91621715|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1884|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.25|0.1884
91621716|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.521|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.20|0.5210
91621717|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3329|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.23|0.3329
91621718|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5173|TWO_SIDED|95.0|-0.21|0.1|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.21|0.5173
91621719|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2346|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.25|0.2346
91621720|NCT02528253|183137523|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.3634|TWO_SIDED|95.0|-0.23|0.09|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.23|0.3634
91621721|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0007|TWO_SIDED|95.0|1.26|2.39|||Regression, Logistic|||Week 2, \>=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.26|0.0007
91621722|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|1.29|0.0004
91621723|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3456|TWO_SIDED|95.0|0.87|1.5|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.87|0.3456
91621724|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2771|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.89|0.2771
91621725|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0594|TWO_SIDED|95.0|0.98|2.41|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.41|0.98|0.0594
91621726|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0105|TWO_SIDED|95.0|1.14|2.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.75|1.14|0.0105
91621727|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.29||||0.236|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|0.85|0.2360
91621728|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3746|TWO_SIDED|95.0|0.81|1.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|0.81|0.3746
91621729|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0974|TWO_SIDED|95.0|0.94|1.99|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.94|0.0974
91660279|NCT00984022|183215407|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Main effect for type of dressing.|ANOVA|||Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.||||.043
91621730|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0806|TWO_SIDED|95.0|0.92|4.08|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.08|0.92|0.0806
91621731|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0407|TWO_SIDED|95.0|1.03|4.47|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.47|1.03|0.0407
91621732|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5966|TWO_SIDED|95.0|0.58|2.58|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.58|0.58|0.5966
91660280|NCT00984022|183215408|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.||||.847
91621733|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.59||||0.1492|TWO_SIDED|95.0|0.85|2.96|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.96|0.85|0.1492
91621734|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.76||||0.072|TWO_SIDED|95.0|0.95|3.24|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.24|0.95|0.0720
91621735|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9926|TWO_SIDED|95.0|0.25|4.0|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.00|0.25|0.9926
91621736|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3726|TWO_SIDED|95.0|0.51|6.04|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.04|0.51|0.3726
91621737|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7874|TWO_SIDED|95.0|0.22|3.12|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.22|0.7874
91621738|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.19||||0.795|TWO_SIDED|95.0|0.32|4.46|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.46|0.32|0.7950
91621739|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2065|TWO_SIDED|95.0|0.66|6.68|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.68|0.66|0.2065
91621740|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0006|TWO_SIDED|95.0|1.23|2.17|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.17|1.23|0.0006
91621741|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.55|2.72|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.72|1.55|<.0001
91621742|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0387|TWO_SIDED|95.0|1.01|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.01|0.0387
91621743|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0903|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.60|0.97|0.0903
91621744|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0006|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.21|0.0006
91524945|NCT05375955|182925305|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
91621745|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0166|TWO_SIDED|95.0|1.08|2.09|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.09|1.08|0.0166
91621746|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0001|TWO_SIDED|95.0|1.36|2.62|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.62|1.36|0.0001
91621747|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1389|TWO_SIDED|95.0|0.93|1.73|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.73|0.93|0.1389
91621748|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2504|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2504
91621749|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0057|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|1.12|0.0057
91722462|NCT01932606|183337711|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume.||||0.4
91621750|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0126|TWO_SIDED|95.0|1.14|2.93|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.93|1.14|0.0126
91621751|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.71|4.22|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.22|1.71|<.0001
91621752|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3485|TWO_SIDED|95.0|0.79|1.99|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.79|0.3485
91621753|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0642|TWO_SIDED|95.0|0.98|2.19|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.98|0.0642
91621754|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.16|||<|0.0001|TWO_SIDED|95.0|1.48|3.14|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.14|1.48|<.0001
91621755|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9819|TWO_SIDED|95.0|0.42|2.31|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.31|0.42|0.9819
91621756|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4333|TWO_SIDED|95.0|0.62|3.02|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.02|0.62|0.4333
91621757|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.91||||0.814|TWO_SIDED|95.0|0.41|2.0|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.41|0.8140
91621758|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8331|TWO_SIDED|95.0|0.49|2.4|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.40|0.49|0.8331
91621759|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.51||||0.2682|TWO_SIDED|95.0|0.73|3.12|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.73|0.2682
91621760|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0001|TWO_SIDED|95.0|1.31|2.29|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.29|1.31|0.0001
91621761|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.49|2.61|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.61|1.49|<.0001
91713445|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6577||||||The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6577
91524946|NCT05375955|182925305|OTHER||Risk Difference (RD)|9.3||||0.1256|TWO_SIDED|95.0|-6.6|26.4|||Chan and Zhang (1999) method|||Week 10||26.4|-6.6|0.1256
91524947|NCT05375955|182925305|OTHER||Risk Difference (RD)|25.5||||0.0038|TWO_SIDED|95.0|7.0|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|7.0|0.0038
91621762|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0071|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0071
91621763|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1187|TWO_SIDED|95.0|0.95|1.57|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.95|0.1187
91621764|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.39||||0.011|TWO_SIDED|95.0|1.08|1.79|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|1.08|0.0110
91621765|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0003|TWO_SIDED|95.0|1.3|2.39|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.30|0.0003
91621766|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.57|2.87|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.87|1.57|<.0001
91660281|NCT00573443|183215409|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5312|||<|0.0001|TWO_SIDED|95.0|0.4939|0.5714|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-30/placebo = 1.||0.5714|0.4939|<0.0001
91660282|NCT00573443|183215409|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5103|||<|0.0001|TWO_SIDED|95.0|0.4755|0.5477|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-20/placebo = 1.||0.5477|0.4755|<0.0001
91660283|NCT04567186|183215427|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.00 logMAR.|Least-square mean|-0.078|STANDARD_ERROR_OF_MEAN|0.0105|||TWO_SIDED|95.0|-0.099|-0.057|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Distance (4 meter)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.099|
91660284|NCT04567186|183215427|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold + 0.17 logMAR.|Least-square mean|-0.059|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.079|-0.039|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Intermediate (64cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.039|-0.079|
91660285|NCT04567186|183215427|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.17 logMAR.|Least-square Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0111|||TWO_SIDED|95.0|0.04|0.084|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|Near (40cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||0.084|0.040|
91660286|NCT04567186|183215428|SUPERIORITY|The superiority of the Test lens was concluded if the lower confidence limit of the least-square mean was above the threshold of 32 points.|Least-square Mean|55.93|STANDARD_ERROR_OF_MEAN|2.9027|||TWO_SIDED|95.0|49.25|62.61|||Linear Mixed Model|The Kenward and Roger method was used for the denominator degrees of freedom||This study was powered to only test primary hypotheses.||62.61|49.25|
91660287|NCT04567186|183215428|NON_INFERIORITY|A Non-Inferiority margin of 5 points was used.|Least-square mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.4708|||TWO_SIDED|95.0|-5.893|-0.073|||Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom|mean difference was calculated as Test minus Control|This study was powered for only the primary hypotheses.||-0.073|-5.893|
91660288|NCT02924883|183215429|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3332||95.0|0.55|1.23|||Log Rank|The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.23|0.55|0.3332
91660289|NCT02924883|183215431|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2934||95.0|0.42|1.3|||Log Rank|The 2-sided log-rank test was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.30|0.42|0.2934
91660290|NCT02924883|183215433|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.6099||95.0|0.52|3.03|||Log Rank|Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).||||3.03|0.52|0.6099
91660291|NCT00904345|183215442|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
91660292|NCT00904345|183215443|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
91660293|NCT00904345|183215447|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
91660294|NCT02481830|183215448|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1144|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.72|0.1144
91660295|NCT02481830|183215449|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|1.16|1.66|||||Hazard Ratio is Nivolumab over Topotecan/Amrubicin using Stratified Cox proportional hazard model|||1.66|1.16|
91660296|NCT02481830|183215450|SUPERIORITY||Estimate of Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.49|1.24|||||Strata adjusted odds ratio (Nivolumab over Topotecan/Amrubicin) using Mantel-Haenszel method|||1.24|0.49|
91660297|NCT02481830|183215451|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.73|
91660298|NCT00772941|183215452|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events."||||<0.001
91660299|NCT00772941|183215453|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events."||||<0.001
91660300|NCT00772941|183215454|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events."||||<0.001
91660301|NCT00772941|183215455|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events."||||<0.001
91660302|NCT00772941|183215456|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events."||||<0.001
91660303|NCT00772941|183215457|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events."||||<0.001
91524948|NCT05375955|182925305|OTHER||Risk Difference (RD)|33.5||||0.0007|TWO_SIDED|95.0|12.8|52.6|||Chan and Zhang (1999) method|||Week 10||52.6|12.8|0.0007
91621767|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0069|TWO_SIDED|95.0|1.11|1.97|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.11|0.0069
91524949|NCT05375955|182925306|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
91524950|NCT05375955|182925306|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
91621768|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2076|TWO_SIDED|95.0|0.91|1.55|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.91|0.2076
91621769|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.86|1.10|0.0072
91524951|NCT05375955|182925306|OTHER||Risk Difference (RD)|2.6||||0.3585|TWO_SIDED|95.0|-9.2|15.5|||Chan and Zhang (1999) method|||Week 2||15.5|-9.2|0.3585
91621770|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0694|TWO_SIDED|95.0|0.97|2.22|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.97|0.0694
91621771|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.53|3.36|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.36|1.53|<.0001
91621772|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.36||||0.121|TWO_SIDED|95.0|0.92|2.0|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.92|0.1210
91621773|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6706|TWO_SIDED|95.0|0.76|1.54|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.76|0.6706
91660304|NCT00772941|183215457|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline."||||<0.001
91722463|NCT01932606|183337712|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure (exercise).||||0.0002
91621774|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0022|TWO_SIDED|95.0|1.2|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.32|1.20|0.0022
91621775|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7546|TWO_SIDED|95.0|0.56|2.22|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.56|0.7546
91660305|NCT00772941|183215458|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline."||||<0.001
91660306|NCT00772941|183215458|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day."||||<0.001
91621776|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7347|TWO_SIDED|95.0|0.57|2.24|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|0.57|0.7347
91621777|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9029|TWO_SIDED|95.0|0.5|1.84|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.84|0.50|0.9029
91621778|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6402|TWO_SIDED|95.0|0.62|2.18|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.18|0.62|0.6402
91660307|NCT00772941|183215459|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline."||||<0.001
91722464|NCT01932606|183337712|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure (exercise).||||0.01
91660308|NCT00772941|183215460|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline."||||<0.001
91621779|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6199|TWO_SIDED|95.0|0.62|2.2|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.20|0.62|0.6199
91621780|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0229|TWO_SIDED|95.0|1.05|1.83|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.05|0.0229
91621781|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0002|TWO_SIDED|95.0|1.3|2.3|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.30|1.30|0.0002
91621782|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.14||||0.315|TWO_SIDED|95.0|0.88|1.47|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.47|0.88|0.3150
91621783|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.21||||0.137|TWO_SIDED|95.0|0.94|1.57|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.94|0.1370
91621784|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0018|TWO_SIDED|95.0|1.17|1.97|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.17|0.0018
91621785|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0342|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.81|1.02|0.0342
91621786|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0003|TWO_SIDED|95.0|1.27|2.24|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|1.27|0.0003
91621787|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2561|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2561
91621788|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2358|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2358
91621789|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.45||||0.004|TWO_SIDED|95.0|1.13|1.87|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.87|1.13|0.0040
91621790|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0723|TWO_SIDED|95.0|0.97|2.02|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.97|0.0723
91621791|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.45|2.92|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|1.45|<.0001
91621792|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0653|TWO_SIDED|95.0|0.98|1.94|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.94|0.98|0.0653
91621793|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9177|TWO_SIDED|95.0|0.74|1.4|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.40|0.74|0.9177
91621794|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0088|TWO_SIDED|95.0|1.11|2.01|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.11|0.0088
91621795|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1197|TWO_SIDED|95.0|0.89|2.83|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.83|0.89|0.1197
91621796|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0913|TWO_SIDED|95.0|0.92|2.92|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|0.92|0.0913
91621797|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4317|TWO_SIDED|95.0|0.72|2.19|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.72|0.4317
91621798|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.27||||0.3498|TWO_SIDED|95.0|0.77|2.08|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.08|0.77|0.3498
91722465|NCT01932606|183337712|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure (exercise).||||0.0002
91621799|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.31||||0.2768|TWO_SIDED|95.0|0.8|2.15|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.15|0.80|0.2768
91621800|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.92|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.92|1.09|0.0101
91660309|NCT00467363|183215483|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0984|TWO_SIDED|95.0|0.98|1.22||Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p\<0.05.|Fisher Exact|No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics||The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.||1.22|0.98|0.0984
91660310|NCT00467363|183215484|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0165|TWO_SIDED|95.0|1.02|1.19|||Fisher Exact|||||1.19|1.02|.0165
91621801|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0054|TWO_SIDED|95.0|1.13|1.99|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|1.13|0.0054
91621802|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5493|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.39|0.84|0.5493
91660311|NCT00467363|183215485|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0329|TWO_SIDED|95.0|1.01|1.19|||Fisher Exact|||||1.19|1.01|.0329
91621803|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0269|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.74|1.03|0.0269
91621804|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.80|1.07|0.0144
91621805|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0846|TWO_SIDED|95.0|0.97|1.7|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.97|0.0846
91621806|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.91|1.09|0.0101
91621807|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0848|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.97|0.0848
91621808|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8732|TWO_SIDED|95.0|0.79|1.32|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.32|0.79|0.8732
91621809|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2734|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.89|0.2734
91621810|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2839|TWO_SIDED|95.0|0.86|1.7|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.86|0.2839
91621811|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0238|TWO_SIDED|95.0|1.05|2.07|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.07|1.05|0.0238
91621812|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5212|TWO_SIDED|95.0|0.81|1.53|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.81|0.5212
91621813|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5954|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.80|0.5954
91621814|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0638|TWO_SIDED|95.0|0.98|1.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|0.98|0.0638
91660312|NCT00467363|183215486|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.8902|TWO_SIDED|95.0|0.64|1.78|||Fisher Exact|||||1.78|.64|.8902
91660313|NCT00467363|183215487|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.6869|TWO_SIDED|95.0|0.76|1.55|||Fisher Exact|||||1.55|.76|.6869
91621815|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2661|TWO_SIDED|95.0|0.78|2.44|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|0.78|0.2661
91621816|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.24||||0.4717|TWO_SIDED|95.0|0.69|2.21|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.21|0.69|0.4717
91621817|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5798|TWO_SIDED|95.0|0.68|2.0|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.68|0.5798
91621818|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5027|TWO_SIDED|95.0|0.72|1.95|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.95|0.72|0.5027
91621819|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8165|TWO_SIDED|95.0|0.64|1.77|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.64|0.8165
91621820|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1996|TWO_SIDED|95.0|0.92|1.52|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.52|0.92|0.1996
91660314|NCT00467363|183215488|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.753|TWO_SIDED|95.0|0.19|2.41|||Fisher Exact|||||2.41|.19|.7530
91660315|NCT00467363|183215489|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.15|7.26|||Fisher Exact|||||7.26|.15|1.000
91660316|NCT00467363|183215490|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
91660317|NCT00467363|183215491|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
91660318|NCT00467363|183215492|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.7943|TWO_SIDED|95.0|0.67|1.76|||Fisher Exact|||||1.76|.67|.7943
91660319|NCT00467363|183215493|SUPERIORITY_OR_OTHER|||||||0.7802|||||||t-test, 2 sided|||||||.7802
91660320|NCT00467363|183215494|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.2603|TWO_SIDED|95.0|0.42|1.23|||Fisher Exact|||||1.23|.42|.2603
91660321|NCT00467363|183215497|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.77|TWO_SIDED|95.0|-0.8|1.4|||Fisher Exact|||||1.4|-0.8|0.77
91660322|NCT03181594|183215498|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.||||<0.001
91660323|NCT03181594|183215500|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91660324|NCT03181594|183215501|SUPERIORITY||||||<|0.001||||||p\<0.001 at all time periods. p\<0.05 was considered statistically significant.|Wilcoxon signed rank|||||||<0.001
91660325|NCT02834663|183215503|SUPERIORITY||Mean Difference (Final Values)|-8.76|STANDARD_DEVIATION|12.521|<|0.0001|TWO_SIDED|95.0|-13.928|-3.592||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||Patients were evaluated for changes in BCVA of the treated eye, from the start of the study till 6 months, until trial completion. After administration of each injection, measurements of BCVA were compared to their respective baseline results. The paired t-test and repeated measures ANOVA was performed for comparative analysis, as all showed normality.||-3.592|-13.928|<0.0001
91660326|NCT02834663|183215504|SUPERIORITY||Mean Difference (Final Values)|110.0|STANDARD_DEVIATION|65.919||0.0001|TWO_SIDED|95.0|82.79|137.21||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||137.210|82.790|0.0001
91660327|NCT02834663|183215505|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_DEVIATION|4.932||0.001|TWO_SIDED|95.0|1.884|5.956||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||5.956|1.884|0.001
91660328|NCT02834663|183215506|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.24||0.0001|TWO_SIDED|95.0|1.3|3.15||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||3.15|1.30|0.0001
91524952|NCT05375955|182925306|OTHER||Risk Difference (RD)|7.4||||0.129|TWO_SIDED|95.0|-5.3|22.1|||Chan and Zhang (1999) method|||Week 2||22.1|-5.3|0.1290
91524953|NCT05375955|182925306|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
91524954|NCT05375955|182925306|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 4||24.3|-8.4|0.2547
91524955|NCT05375955|182925306|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 6||20.5|-9.5|0.2751
91660329|NCT02834663|183215507|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
91660330|NCT02834663|183215508|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
91660331|NCT02834663|183215509|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_DEVIATION|1.87||0.221|TWO_SIDED|95.0|-0.751|0.795||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||0.795|-0.751|0.221
91660332|NCT00904215|183215517|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Student Paired t-test|||||||<0.0001
91660333|NCT00904215|183215518|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
91660334|NCT00904215|183215519|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
91660335|NCT00904215|183215520|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
91660336|NCT00982397|183215524|SUPERIORITY_OR_OTHER||percentage of participants|98.5|||||TWO_SIDED|95.0|97.9|99.0|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.||99.0|97.9|
91660337|NCT00982397|183215524|SUPERIORITY_OR_OTHER||percentage of participants|97.5|||||TWO_SIDED|95.0|96.1|98.5|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.||98.5|96.1|
91621821|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0074|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0074
91621822|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3557|TWO_SIDED|95.0|0.87|1.45|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.45|0.87|0.3557
91621823|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|1.06|0.0170
91621824|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8641|TWO_SIDED|95.0|0.76|1.38|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.38|0.76|0.8641
91621825|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1768|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1768
91621826|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7696|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.55|0.7696
91621827|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7433|TWO_SIDED|95.0|0.66|1.78|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.78|0.66|0.7433
91660338|NCT00982397|183215525|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison against a performance criterion of 10%.|Exact Binomial|||Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.||||<0.0001
91660339|NCT00982397|183215526|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.|Confidence interval and hypothesis test|||P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.||||<0.0001
91621828|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0562|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0562
91621829|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0274|TWO_SIDED|95.0|1.03|1.71|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.03|0.0274
91524956|NCT05375955|182925306|OTHER||Risk Difference (RD)|12.3||||0.0658|TWO_SIDED|95.0|-3.8|28.8|||Chan and Zhang (1999) method|||Week 6||28.8|-3.8|0.0658
91524957|NCT05375955|182925306|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
91524958|NCT05375955|182925306|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
91524959|NCT05375955|182925306|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
91524960|NCT05375955|182925306|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
91621830|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1206|TWO_SIDED|95.0|0.95|1.58|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.95|0.1206
91621831|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0365|TWO_SIDED|95.0|1.02|1.69|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.69|1.02|0.0365
91621832|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0964|TWO_SIDED|95.0|0.96|1.71|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.96|0.0964
91660340|NCT00982397|183215527|NON_INFERIORITY_OR_EQUIVALENCE|Ho: p1 ≤ p2 - 0.05 Ha: p1 \> p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.|Risk Difference (RD)|0.0||||0.0013|TWO_SIDED|90.0|-2.7|2.7||P-Value is for non-inferiority|Farrington-Manning||The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.|The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.||2.7|-2.7|0.0013
91621833|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2515|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2515
91621834|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8122|TWO_SIDED|95.0|0.66|1.71|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.66|0.8122
91621835|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1848|TWO_SIDED|95.0|0.86|2.13|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.13|0.86|0.1848
91621836|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2622|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2622
91621837|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1579|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.93|0.1579
91621838|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2773|TWO_SIDED|95.0|0.89|1.49|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.89|0.2773
91621839|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1032|TWO_SIDED|95.0|0.96|1.59|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.96|0.1032
91660341|NCT00838630|183215528|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.27||||||90.0|92.32|104.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.61|92.32|
91660342|NCT00838630|183215529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for log-transformed AUC0-t, AUC0-inf, and Cmax parameters.|Geometric Test/Ref Ratio x 100|94.37||||||90.0|90.47|98.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.43|90.47|
91660343|NCT00838630|183215530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.7||||||90.0|91.52|100.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.08|91.52|
91621840|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4418|TWO_SIDED|95.0|0.84|1.5|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.84|0.4418
91621841|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1608|TWO_SIDED|95.0|0.92|1.63|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.63|0.92|0.1608
91621842|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2628|TWO_SIDED|95.0|0.83|2.02|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.83|0.2628
91621843|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0447|TWO_SIDED|95.0|1.01|2.39|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.01|0.0447
91621844|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.16||||0.256|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2560
91660344|NCT00578552|183215542|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.77
91621845|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1741|TWO_SIDED|95.0|0.93|1.53|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.93|0.1741
91621846|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1647|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.93|0.1647
91621847|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0619|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0619
91621848|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2025|TWO_SIDED|95.0|0.9|1.61|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.61|0.90|0.2025
91621849|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2601|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.88|0.2601
91621850|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5635|TWO_SIDED|95.0|0.73|1.77|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.73|0.5635
91621851|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1338|TWO_SIDED|95.0|0.91|2.11|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.11|0.91|0.1338
91621852|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2137|TWO_SIDED|95.0|0.91|1.51|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.91|0.2137
91660345|NCT00578552|183215542|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||1.00
91660346|NCT00833937|183215612|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|99.7||||||90.0|93.9|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|93.9|
91660347|NCT00833937|183215613|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.8||||||90.0|92.6|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.6|
91621853|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0256|TWO_SIDED|95.0|1.04|1.72|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|1.04|0.0256
91621854|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3531|TWO_SIDED|95.0|0.87|1.46|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.46|0.87|0.3531
91621855|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0358|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|1.02|0.0358
91621856|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.22||||0.184|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1840
91621857|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.25||||0.125|TWO_SIDED|95.0|0.94|1.67|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.67|0.94|0.1250
91621858|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8266|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.61|0.8266
91621859|NCT02528253|183137526|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5673|TWO_SIDED|95.0|0.74|1.72|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|0.74|0.5673
91621860|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0076|TWO_SIDED|95.0|1.12|2.08|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.08|1.12|0.0076
91621861|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.0001|TWO_SIDED|95.0|1.46|2.69|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.69|1.46|<.0001
91621862|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.31||||0.07|TWO_SIDED|95.0|0.98|1.74|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|0.98|0.0700
91660348|NCT00833937|183215614|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.9||||||90.0|92.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.7|
91660349|NCT01985308|183215615|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91660350|NCT04115293|183215618|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.24|-0.95|||MMRM ANCOVA|||||-0.95|-3.24|<0.001
91660351|NCT04115293|183215619|SUPERIORITY||LS Mean Difference|-2.94|||<|0.001|TWO_SIDED|95.0|-4.39|-1.49|||MMRM ANCOVA|||||-1.49|-4.39|<0.001
91660352|NCT04115293|183215620|SUPERIORITY||LS Mean Difference|-3.2||||0.0023|TWO_SIDED|95.0|-5.24|-1.16|||MMRM ANCOVA|||||-1.16|-5.24|0.0023
91660353|NCT04115293|183215621|SUPERIORITY||LS Mean Difference|-2.49||||0.0128|TWO_SIDED|95.0|-4.45|-0.54|||MMRM ANCOVA|||||-0.54|-4.45|0.0128
91660354|NCT04115293|183215623|SUPERIORITY||Odds Ratio (OR)|2.608||||0.0885|TWO_SIDED|95.0|0.866|7.86|||Regression, Logistic|||||7.860|0.866|0.0885
91660355|NCT04115293|183215624|SUPERIORITY||Odds Ratio (OR)|3.184|||<|0.001|TWO_SIDED|95.0|1.662|6.101|||Regression, Logistic|||||6.101|1.662|<0.001
91660356|NCT04115293|183215625|SUPERIORITY||Odds Ratio (OR)|2.865||||0.0012|TWO_SIDED|95.0|1.518|5.409|||Regression, Logistic|||||5.409|1.518|0.0012
91621863|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2655|TWO_SIDED|95.0|0.89|1.54|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.89|0.2655
91621864|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0022|TWO_SIDED|95.0|1.16|1.98|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.98|1.16|0.0022
91660357|NCT03772522|183215632|SUPERIORITY||Cohen's d (effect size)|0.384||||0.428|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.428
91621865|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0125|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.11|0.0125
91660358|NCT03772522|183215632|SUPERIORITY||Cohen's d (effect size)|-0.46||||0.058|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and immediately post-intervention.||||0.058
91621866|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.21|0.0032
91621867|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1528|TWO_SIDED|95.0|0.91|1.85|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|0.91|0.1528
91621868|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1863|TWO_SIDED|95.0|0.9|1.72|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|0.90|0.1863
91621869|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0667|TWO_SIDED|95.0|0.98|1.86|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|0.98|0.0667
91660359|NCT03772522|183215632|SUPERIORITY||Cohen's d (effect size)|-0.4||||0.095|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.||||0.095
91660360|NCT03772522|183215632|SUPERIORITY||Cohen's d (effect size)|-0.73||||0.005|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.||||0.005
91660361|NCT03772522|183215632|SUPERIORITY||Cohen's d (effect size)|-0.6||||0.022|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.||||0.022
91660362|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|1.792||||0.002|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.||||0.002
91660363|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.047||||0.923|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.||||0.923
91660364|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.6||||0.18|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.18
91660365|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.2||||0.388|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.388
91660366|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.52||||0.037|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.037
91660367|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.09||||0.688|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.688
91524961|NCT05375955|182925306|OTHER||Risk Difference (RD)|7.9||||0.2736|TWO_SIDED|95.0|-9.5|25.7|||Chan and Zhang (1999) method|||Week 12||25.7|-9.5|0.2736
91621870|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0101|TWO_SIDED|95.0|1.18|3.39|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.39|1.18|0.0101
91621871|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0162|TWO_SIDED|95.0|1.13|3.25|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.13|0.0162
91621872|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5599|TWO_SIDED|95.0|0.69|1.99|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|0.69|0.5599
91621873|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.71||||0.0202|TWO_SIDED|95.0|1.09|2.68|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.68|1.09|0.0202
91621874|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0335|TWO_SIDED|95.0|1.04|2.57|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.57|1.04|0.0335
91621875|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0416|TWO_SIDED|95.0|1.04|6.17|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||6.17|1.04|0.0416
91621876|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0075|TWO_SIDED|95.0|1.37|7.69|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||7.69|1.37|0.0075
91621877|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5374|TWO_SIDED|95.0|0.53|3.34|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.34|0.53|0.5374
91621878|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.89||||0.082|TWO_SIDED|95.0|0.92|3.89|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.89|0.92|0.0820
91621879|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0108|TWO_SIDED|95.0|1.23|4.81|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.81|1.23|0.0108
91660368|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.51||||0.038|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.038
91660369|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.01||||0.956|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.956
91660370|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|0.32||||0.197|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.197
91621880|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0006|TWO_SIDED|95.0|1.24|2.2|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.24|0.0006
91621881|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.47|2.59|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.59|1.47|<.0001
91621882|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0963|TWO_SIDED|95.0|0.96|1.63|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.63|0.96|0.0963
91660371|NCT03772522|183215633|SUPERIORITY||Cohen's d (effect size)|-0.07||||0.762|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.762
91660372|NCT03772522|183215634|SUPERIORITY||Cohen's d (effect size)|0.101||||0.834|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.834
91660373|NCT03772522|183215634|SUPERIORITY||Cohen's d (effect size)|0.19||||0.417|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.||||0.417
91660374|NCT03772522|183215634|SUPERIORITY||Cohen's d (effect size)|0.42||||0.087|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.087
91524962|NCT05375955|182925306|OTHER||Risk Difference (RD)|12.7||||0.1119|TWO_SIDED|95.0|-5.6|31.0|||Chan and Zhang (1999) method|||Week 12||31.0|-5.6|0.1119
91621883|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0332|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0332
91621884|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0007|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.01|1.21|0.0007
91621885|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0001|TWO_SIDED|95.0|1.37|2.64|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.64|1.37|0.0001
91621886|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.6|3.05|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.05|1.60|<.0001
91621887|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0235|TWO_SIDED|95.0|1.05|1.95|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.05|0.0235
91621888|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0459|TWO_SIDED|95.0|1.01|1.76|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.76|1.01|0.0459
91621889|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.54||||0.002|TWO_SIDED|95.0|1.17|2.04|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.04|1.17|0.0020
91621890|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.93||||0.0019|TWO_SIDED|95.0|1.27|2.91|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.91|1.27|0.0019
91621891|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.62|3.62|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.62|1.62|<.0001
91621892|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6765|TWO_SIDED|95.0|0.72|1.65|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.72|0.6765
91621893|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.23|2.54|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.23|0.0022
91621894|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.56|3.15|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.15|1.56|<.0001
91621895|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.98||||0.027|TWO_SIDED|95.0|1.08|3.63|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.63|1.08|0.0270
91621896|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.43||||0.003|TWO_SIDED|95.0|1.35|4.38|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.38|1.35|0.0030
91621897|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|0.74||||0.377|TWO_SIDED|95.0|0.38|1.44|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.44|0.38|0.3770
91621898|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0009|TWO_SIDED|95.0|1.49|4.79|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.79|1.49|0.0009
91524963|NCT05375955|182925307|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
91524964|NCT05375955|182925307|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 1||14.9|-7.8|0.2697
91621899|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.0001|TWO_SIDED|95.0|1.87|5.78|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.78|1.87|<.0001
91621900|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0011|TWO_SIDED|95.0|1.2|2.1|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.10|1.20|0.0011
91621901|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.41|2.47|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.41|<.0001
91621902|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0273|TWO_SIDED|95.0|1.03|1.72|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|1.03|0.0273
91621903|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1736|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.93|0.1736
91621904|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0092|TWO_SIDED|95.0|1.09|1.81|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.09|0.0092
91660375|NCT03772522|183215634|SUPERIORITY||Cohen's d (effect size)|0.33||||0.168|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.168
91621905|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0015|TWO_SIDED|95.0|1.2|2.2|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.20|0.0015
91621906|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.45|2.63|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.63|1.45|<.0001
91621907|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0164|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.06|0.0164
91621908|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2857|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.51|0.89|0.2857
91621909|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0149|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.80|1.07|0.0149
91621910|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0001|TWO_SIDED|95.0|1.43|3.02|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.02|1.43|0.0001
91621911|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.57|3.28|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.28|1.57|<.0001
91621912|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.34||||0.118|TWO_SIDED|95.0|0.93|1.92|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.92|0.93|0.1180
91621913|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0062|TWO_SIDED|95.0|1.13|2.14|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.14|1.13|0.0062
91621914|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0009|TWO_SIDED|95.0|1.24|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.24|0.0009
91621915|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0003|TWO_SIDED|95.0|1.56|4.61|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.61|1.56|0.0003
91660376|NCT03772522|183215634|SUPERIORITY||Cohen's d (effect size)|0.37||||0.133|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.133
91621916|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.82|5.28|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.28|1.82|<.0001
91621917|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.33||||0.312|TWO_SIDED|95.0|0.76|2.32|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|0.76|0.3120
91621918|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0019|TWO_SIDED|95.0|1.3|3.14|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.14|1.30|0.0019
91621919|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0001|TWO_SIDED|95.0|1.52|3.59|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.59|1.52|0.0001
91621920|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0064|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.12|0.0064
91621921|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.32|2.31|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.32|0.0001
91621922|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2757|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2757
91660377|NCT03772522|183215635|SUPERIORITY||Cohen's d (effect size)|1.161||||0.026|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.026
91660378|NCT03772522|183215635|SUPERIORITY||Cohen's d (effect size)|0.62||||0.014|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.||||0.014
91660379|NCT03772522|183215635|SUPERIORITY||Cohen's d (effect size)|0.29||||0.217|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.217
91660380|NCT03772522|183215635|SUPERIORITY||Cohen's d (effect size)|0.71||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.006
91660381|NCT03772522|183215635|SUPERIORITY||Cohen's d (effect size)|0.53||||0.039|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.039
91660382|NCT02883452|183215688|NON_INFERIORITY|The non-inferiority of CT-P13 SC to CT-P13 IV was to be concluded if the lower bound of two-sided 90% CI for the ratio of geometric least square means was higher than 80%.|Ratio of Geometric LS means|1154.17|||||TWO_SIDED|90.0|786.37|1694.0|||||The geometric lease square (LS) means, ratio of geometric LS means (CT-P13 SC 120/240 mg to CT-P13 IV 5 mg/kg), and 2-sided 90% CI were obtained from the ANCOVA model.|Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index \[CDAI\]-70 for CD or partial Mayo score for UC), body weight at Week 6 (\<80 kg or ≥80 kg) fitted as covariates.||1694.00|786.37|
91660383|NCT01281501|183215695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|5.0||0.6|TWO_SIDED|95.0|-12.7|7.4|||t-test, 2 sided|||Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.||7.4|-12.7|0.6
91660384|NCT00905840|183215701|NON_INFERIORITY_OR_EQUIVALENCE|The analysis of the primary outcome variable, was based on a confirmatory non-inferiority test with a one-sided 97.5% confidence interval. The non-inferiority margin for a clinically relevant difference was set at 0.1 mm. For a sample size of st least 73, a paired t-test with a 0.0025 one-sided significant level was calculated to have 80% power to reject the hypothesis that the test is inferior to the standard.|Mean Difference (Final Values)|0.1||||0.025|TWO_SIDED|97.5|0.1|0.3|||Student's t-test|||"Null hypothesis: Change of functional bone level at the test implant 12 month after surgery is more than 0.1 lower (inferior) than change of functional crestal bone level at the control implant 12 month after surgery.~H-1: Change of functional bone level at the tst implant 12 month after surgery is up to 0.1 lower, equal, or higher (not inferior) than change of functional crestal bone level at the control implant 12 month after surgery."||0.3|0.1|0.025
91660385|NCT00905840|183215702|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|95.0|||||McNemar|||This analysis is up to 12 month.||||0.1573
91660386|NCT00905840|183215703|SUPERIORITY_OR_OTHER|||||||0.3617|TWO_SIDED|||||12 month data Plaque index|Wilcoxon (Mann-Whitney)|||||||0.3617
91660387|NCT00905840|183215703|SUPERIORITY_OR_OTHER|||||||0.7068|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Plaque index||||||0.7068
91660388|NCT00905840|183215703|SUPERIORITY_OR_OTHER|||||||0.4312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Plaque Index||||||0.4312
91660389|NCT00905840|183215703|SUPERIORITY_OR_OTHER|||||||0.9933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|12 month data Sulcus Bleeding Index||||||0.9933
91660390|NCT00905840|183215703|SUPERIORITY_OR_OTHER|||||||0.3667|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Sulcus Bleeding Index||||||0.3667
91660391|NCT00905840|183215703|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Sulcus Bleeding Index||||||1.0000
91524965|NCT05375955|182925307|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
91660392|NCT02251886|183215707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.48|TWO_SIDED|95.0|0.77|1.76|||Chi-squared|||||1.76|0.77|0.48
91660393|NCT02251886|183215707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.69|1.46|||Chi-squared|||||1.46|0.69|1.00
91660394|NCT01593852|183215709|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91660395|NCT01593852|183215717|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91660396|NCT05169710|183215725|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.857||0.1718|TWO_SIDED|95.0|-9.64|1.75|||Mixed Models Analysis|||||1.75|-9.64|0.1718
91660397|NCT05169710|183215725|SUPERIORITY||Mean Difference (Final Values)|-6.34|STANDARD_ERROR_OF_MEAN|2.837||0.0286|TWO_SIDED|95.0|-11.99|-0.68|||Mixed Models Analysis|||||-0.68|-11.99|0.028600
91660398|NCT05169710|183215726|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.7314|TWO_SIDED|95.0|-0.72|0.51|||Mixed Models Analysis|||||0.51|-0.72|0.7314
91660399|NCT05169710|183215726|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.305||0.3169|TWO_SIDED|95.0|-0.91|0.3|||Mixed Models Analysis|||||0.3|-0.91|0.3169
91713446|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.|Wilcoxon test|||||||0.88
91524966|NCT05375955|182925307|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
91621923|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0575|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.99|0.0575
91621924|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0015|TWO_SIDED|95.0|1.17|1.96|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.96|1.17|0.0015
91621925|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
91621926|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.31|2.31|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.31|0.0001
91621927|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0124|TWO_SIDED|95.0|1.07|1.79|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.79|1.07|0.0124
91621928|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0025|TWO_SIDED|95.0|1.15|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.15|0.0025
91621929|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0002|TWO_SIDED|95.0|1.33|2.51|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.51|1.33|0.0002
91660400|NCT01864174|183215742|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study provided 90% power to demonstrate noninferiority in change from baseline mean HbA1c at Week 24, with an assumed standard deviation (SD) of 1.0%, a non-inferiority margin of 0.3%, and 2-sided alpha of 0.05 for the primary comparison|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.0687|||TWO_SIDED|95.0|-0.1|0.17|||||METFORMIN XR VS METFORMIN IR|||0.17|-0.10|
91660401|NCT03273153|183215780|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2954|TWO_SIDED|95.0|0.88|1.5|||Regression, Cox|||||1.50|0.88|0.2954
91524967|NCT05375955|182925307|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
91524968|NCT05375955|182925307|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
91524969|NCT05375955|182925307|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
91621930|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.48|2.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.79|1.48|<.0001
91621931|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5701|TWO_SIDED|95.0|0.8|1.49|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.49|0.80|0.5701
91660402|NCT01237054|183215799|SUPERIORITY|||||||0.024||||||The reported p-value is representative of the difference in levels of Ang2 in both groups.|Wilcoxon rank sum test|||||||0.024
91660403|NCT01237054|183215799|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of G-CSF in both groups.|Wilcoxon rank sum test|||||||0.055
91660404|NCT01237054|183215799|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of Follistatin in both groups.|Wilcoxon rank sum test|||||||0.055
91660405|NCT01237054|183215799|SUPERIORITY|||||||0.0098||||||The reported p-value is representative of the difference in levels of HGF in both groups.|Wilcoxon rank sum test|||||||0.0098
91621932|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0004|TWO_SIDED|95.0|1.26|2.22|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.22|1.26|0.0004
91621933|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.0001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.46|1.40|<.0001
91621934|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0008|TWO_SIDED|95.0|1.35|3.17|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.17|1.35|0.0008
91621935|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0059|TWO_SIDED|95.0|1.19|2.83|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.83|1.19|0.0059
91621936|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7741|TWO_SIDED|95.0|0.6|1.46|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.46|0.60|0.7741
91621937|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.5|3.25|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.50|<.0001
91621938|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0008|TWO_SIDED|95.0|1.32|2.9|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.90|1.32|0.0008
91621939|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.25||||0.089|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.97|0.0890
91660406|NCT01237054|183215799|SUPERIORITY|||||||0.02||||||The reported p-value is representative of the difference in levels of VEGF-A in both groups.|Wilcoxon rank sum test|||||||0.02
91660407|NCT01237054|183215800|OTHER|Other, trend test.||||||0.008|||||||Jonckheere-Terpstra test for trend|||||||0.008
91621940|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0067|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.83|1.10|0.0067
91621941|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.85|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|1.10|0.0072
91621942|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.06|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.06|1.23|0.0004
91621943|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0013|TWO_SIDED|95.0|1.2|2.15|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.15|1.20|0.0013
91621944|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.34|2.39|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.39|1.34|<.0001
91621945|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.51|3.3|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.30|1.51|<.0001
91621946|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.72|3.71|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.71|1.72|<.0001
91621947|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0732|TWO_SIDED|95.0|0.98|1.62|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.62|0.98|0.0732
91621948|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0399|TWO_SIDED|95.0|1.01|1.68|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.68|1.01|0.0399
91660408|NCT01237054|183215801|OTHER|Other, trend test.||||||0.15||||||The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.15
91660409|NCT01237054|183215801|OTHER|Other, trend test.||||||0.33||||||The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.33
91660410|NCT01237054|183215802|SUPERIORITY|||||||0.08|||||||Wilcoxon rank sum test|||||||0.08
91660411|NCT01237054|183215803|SUPERIORITY|||||||0.011|||||||Wilcoxon rank sum test|||||||0.011
91660412|NCT05323396|183215824|OTHER|||||||0.19|||||||Student's unpaired t-test|||||||0.19
91660413|NCT05323396|183215825|OTHER|||||||0.85|||||||Student's unpaired t-test|||||||0.85
91660414|NCT05323396|183215826|OTHER|||||||0.77|||||||Student's unpaired t-test|||||||0.77
91660415|NCT05323396|183215827|OTHER|||||||0.12|||||||student's unpaired t-test|||||||0.12
91660416|NCT05323396|183215828|OTHER|||||||0.81|||||||student's unpaired t-test|||||||0.81
91660417|NCT05323396|183215829|OTHER|||||||0.65|||||||student's unpaired t-test|||||||0.65
91660418|NCT01790581|183215865|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||MANOVA|||This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.||||.904
91660419|NCT01790581|183215867|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||MANOVA|||This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.||||.5
91660420|NCT02305758|183215910|SUPERIORITY||Hazard Ratio (HR)|0.939|||||TWO_SIDED|95.0|0.596|1.48||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||1.480|0.596|
91524970|NCT05375955|182925307|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
91621949|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0536|TWO_SIDED|95.0|1.0|1.67|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.67|1.00|0.0536
91621950|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0043|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.12|0.0043
91621951|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0143|TWO_SIDED|95.0|1.07|1.91|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.07|0.0143
91621952|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
91621953|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.67||||0.005|TWO_SIDED|95.0|1.17|2.38|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.38|1.17|0.0050
91621954|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0043|TWO_SIDED|95.0|1.18|2.4|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.18|0.0043
91621955|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2777|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2777
91621956|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0326|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.70|1.02|0.0326
91621957|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1823|TWO_SIDED|95.0|0.92|1.55|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.92|0.1823
91621958|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.32||||0.035|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0350
91660421|NCT02305758|183215911|SUPERIORITY||Hazard Ratio (HR)|1.261|||||TWO_SIDED|95.0|0.738|2.156||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||2.156|0.738|
91621959|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0164|TWO_SIDED|95.0|1.07|1.88|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.07|0.0164
91524971|NCT05375955|182925307|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
91621960|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0257|TWO_SIDED|95.0|1.04|1.84|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.84|1.04|0.0257
91621961|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.35|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.14|0.0070
91621962|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0085|TWO_SIDED|95.0|1.13|2.32|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.13|0.0085
91621963|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4925|TWO_SIDED|95.0|0.85|1.41|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.41|0.85|0.4925
91660422|NCT02305758|183215912|SUPERIORITY||Difference in proportions|-4.62|||||TWO_SIDED|95.0|-21.4|12.1|||Mantel Haenszel|||Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).||12.1|-21.4|
91660423|NCT01424644|183215929|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to diphtheria toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination|Vaccine group difference|13.0|||||TWO_SIDED|95.0|9.0|17.0|||Miettinen and Nurminen|||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo||17|9|
91713447|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.|Wilcoxon test|||||||0.74
91722466|NCT01932606|183337712|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PCWP (exercise).||||0.0002
91660424|NCT01424644|183215929|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to tetanus toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+ Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||2|-2|
91660425|NCT01424644|183215930|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PT antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the ratio of the GMCs of the MenACWY-CRM +Tdap+HPV group to the Placebo+Tdap + HPV group was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio-Geometric mean conc|1.01|||||TWO_SIDED|95.0|0.89|1.14|||ANOVA|||Non-inferiority of anti-PT immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||1.14|0.89|
91524972|NCT05375955|182925307|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
91713448|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.|Wilcoxon test|||||||0.20
91713449|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6295||||||The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6295
91524973|NCT05375955|182925307|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
91524974|NCT05375955|182925307|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
91621964|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1534|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.93|0.1534
91621965|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1202|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1202
91621966|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1222|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1222
91621967|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0179|TWO_SIDED|95.0|1.06|1.9|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.90|1.06|0.0179
91621968|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0065|TWO_SIDED|95.0|1.12|1.99|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|1.12|0.0065
91621969|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0223|TWO_SIDED|95.0|1.06|2.2|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.06|0.0223
91621970|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0045|TWO_SIDED|95.0|1.17|2.4|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.17|0.0045
91621971|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.77|1.28|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.28|0.77|0.9385
91621972|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1093|TWO_SIDED|95.0|0.95|1.59|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.59|0.95|0.1093
91621973|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.21||||0.1631|TWO_SIDED|95.0|0.93|1.57|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.57|0.93|0.1631
91621974|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0285|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|1.03|0.0285
91621975|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0389|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.02|0.0389
91621976|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.39||||0.024|TWO_SIDED|95.0|1.04|1.86|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.04|0.0240
91621977|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0063|TWO_SIDED|95.0|1.15|2.34|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.34|1.15|0.0063
91524975|NCT05375955|182925307|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
91621978|NCT02528253|183137527|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0021|TWO_SIDED|95.0|1.22|2.47|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.22|0.0021
91621979|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0003|TWO_SIDED|95.0|-0.75|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.75|0.0003
91621980|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.85|-0.33|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.33|-0.85|<.0001
91621981|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0615|TWO_SIDED|95.0|-0.47|0.01|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.47|0.0615
91660426|NCT01424644|183215930|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to FHA antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM +Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio- Geometric mean conc|0.84|||||TWO_SIDED|95.0|0.76|0.93|||ANOVA|||Non-inferiority of anti-FHA immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.76|
91660427|NCT01424644|183215930|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PRN antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM+Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after vaccination.|Vaccine group ratio-Geometric mean conc|0.82|||||TWO_SIDED|95.0|0.72|0.93|||ANOVA|||Non-inferiority of anti-PRN immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.72|
91660428|NCT00440297|183215941|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|48.5||||||95.0|38.4|58.7|||||Exact binomial confidence interval.|No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose among subjects who were seronegative at baseline||58.7|38.4|
91660429|NCT00440297|183215941|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|57.7||||||95.0|47.9|67.0|||||Exact binomial confidence interval.|||67.0|47.9|
91660430|NCT00440297|183215942|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|66.7||||||95.0|56.5|75.8|||||Exact binomial confidence interval|||75.8|56.5|
91660431|NCT00440297|183215942|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|69.2||||||95.0|59.4|77.9|||||Exact binomial confidence interval|||77.9|59.4|
91660432|NCT02024932|183215963|SUPERIORITY_OR_OTHER_LEGACY||Geo-mean ratio|1.037||||0.0164|TWO_SIDED|90.0|1.009|1.065|||ANCOVA|||||1.065|1.009|0.0164
91660433|NCT03020641|183215989|OTHER|t-test|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2347||0.058|TWO_SIDED|95.0||0.1276||the threshold for statistical significance was p\<=0.05.|t-test, 2 sided|||Interleukin 1 (IL1)||0.1276|- 0.8077|0.058
91660434|NCT03020641|183215989|OTHER|Interleukin 6 (IL6)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.29||0.001|TWO_SIDED|95.0|-1.6|-0.44|||t-test, 2 sided|||||-0.44|-1.60|0.001
91660435|NCT03020641|183215989|OTHER||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.211||0.052|TWO_SIDED|95.0|-0.76|0.81|||t-test, 2 sided|||Interleukin 10||0.81|-0.76|0.052
91660436|NCT03020641|183215989|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.181||0.815|TWO_SIDED|95.0|-0.5|0.22|||t-test, 2 sided|||Vascular Endotelial Grow Factor A||0.22|-0.50|0.815
91660437|NCT03020641|183215989|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.742|TWO_SIDED|95.0|-0.42|0.36|||t-test, 2 sided|||TNF alfa||0.36|-0.42|0.742
91660438|NCT03020641|183215989|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.2||0.603|TWO_SIDED|95.0|-0.36|0.44|||t-test, 2 sided|||Chemokine CXC ligand 2||0.44|-0.36|0.603
91660439|NCT03020641|183215990|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.47|0.65|||t-test, 2 sided|||Matrix metalloproteinase-9||0.65|-0.47|0.600
91660440|NCT03020641|183215990|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028|TWO_SIDED|95.0|0.03|0.97|||t-test, 2 sided|||Plasminogen activator inhibitor-1||0.97|0.030|0.028
91660441|NCT03020641|183215990|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.36||0.807|TWO_SIDED|95.0|-0.64|0.82|||t-test, 2 sided|||E-selectin||0.82|-0.64|0.807
91660442|NCT03020641|183215992|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|4.44||0.862|TWO_SIDED|95.0|-7.49|10.21|||t-test, 2 sided|||||10.21|-7.49|0.862
91660443|NCT03238781|183216000|SUPERIORITY||difference in least square mean|0.26||||0.66|TWO_SIDED|95.0|-0.88|1.4||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.40|-0.88|0.66
91660444|NCT03238781|183216000|SUPERIORITY||difference in least square mean|0.27||||0.65|TWO_SIDED|95.0|-0.89|1.43||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.43|-0.89|0.65
91660445|NCT03238781|183216001|SUPERIORITY||Odds Ratio (OR)|0.82||||0.57|TWO_SIDED|95.0|0.41|1.62||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.62|0.41|0.57
91660446|NCT03238781|183216001|SUPERIORITY||Odds Ratio (OR)|0.76||||0.45|TWO_SIDED|95.0|0.37|1.54||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.54|0.37|0.45
91713450|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.|Wilcoxon test|||||||0.63
91722467|NCT01932606|183337713|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in heart rate.||||0.3
91621982|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.0356|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.50|0.0356
91621983|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0032|TWO_SIDED|95.0|-0.6|-0.12|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.60|0.0032
91621984|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.88|-0.27|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.27|-0.88|0.0003
91621985|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.08|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.08|<.0001
91621986|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.15||0.0844|TWO_SIDED|95.0|-0.54|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.54|0.0844
91621987|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.6|-0.04|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.60|0.0258
91621988|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.8|-0.23|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.23|-0.80|0.0004
91621989|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0079|TWO_SIDED|95.0|-0.78|-0.12|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.78|0.0079
91621990|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.08|-0.41|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-1.08|<.0001
91660447|NCT03238781|183216002|SUPERIORITY||difference in least square mean|-0.03||||0.94|TWO_SIDED|95.0|-0.87|0.81||2-sided significance level of 0.05|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||0.81|-0.87|0.94
91660448|NCT03238781|183216002|SUPERIORITY||difference in least square mean|-0.09||||0.84|TWO_SIDED|95.0|-0.94|0.77||2-sided significance level of 0.05|Mixed Models Analysis|||||0.77|-0.94|0.84
91621991|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.0977|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.57|0.0977
91621992|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.50|0.2150
91621993|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.0016|TWO_SIDED|95.0|-0.79|-0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.79|0.0016
91660449|NCT03238781|183216003|SUPERIORITY||difference in least square mean|-0.28||||0.81|TWO_SIDED|95.0|-2.56|2.01||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.01|-2.56|0.81
91621994|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0058|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.88|0.0058
91722468|NCT01932606|183337714|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.2
91621995|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.19||0.0038|TWO_SIDED|95.0|-0.91|-0.18|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.91|0.0038
91621996|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.17||0.1707|TWO_SIDED|95.0|-0.58|0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.58|0.1707
91621997|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.1083|TWO_SIDED|95.0|-0.62|0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.62|0.1083
91621998|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0734|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.64|0.0734
91621999|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.21||0.4603|TWO_SIDED|95.0|-0.56|0.25|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.56|0.4603
91622000|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0799|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.74|0.0799
91622001|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.21||0.2339|TWO_SIDED|95.0|-0.66|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.66|0.2339
91622002|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.1199|TWO_SIDED|95.0|-0.73|0.08|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.73|0.1199
91622003|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.21||0.384|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.60|0.3840
91660450|NCT03238781|183216003|SUPERIORITY||difference in least square mean|0.31||||0.79|TWO_SIDED|95.0|-2.01|2.63||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.63|-2.01|0.79
91622004|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.68|0.14|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.68|0.2000
91622005|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2997|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2997
91713451|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.999||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.|Wilcoxon test|||||||>0.999
91524976|NCT05375955|182925307|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
91524977|NCT05375955|182925307|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
91622006|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.1778|TWO_SIDED|95.0|-0.71|0.13|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.71|0.1778
91622007|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3438|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.65|0.3438
91622008|NCT02528253|183137529|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.1876|TWO_SIDED|95.0|-0.71|0.14|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.71|0.1876
91622009|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.72|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.72|0.0002
91622010|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.79|<.0001
91622011|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0193|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.50|0.0193
91622012|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0845|TWO_SIDED|95.0|-0.42|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.42|0.0845
91622013|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0212|TWO_SIDED|95.0|-0.49|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.49|0.0212
91622014|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.81|-0.24|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.81|0.0003
91660451|NCT03238781|183216004|SUPERIORITY||difference in least square mean|-0.86||||0.46|TWO_SIDED|95.0|-3.15|1.44||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.44|-3.15|0.46
91660452|NCT03238781|183216004|SUPERIORITY||difference in least square mean|0.56||||0.64|TWO_SIDED|95.0|-1.77|2.89||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.89|-1.77|0.64
91622015|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.41|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-0.99|<.0001
91622016|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.079|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.50|0.0790
91622017|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.0336|TWO_SIDED|95.0|-0.55|-0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.55|0.0336
91660453|NCT03161405|183216014|OTHER||Geometric mean ratio|1.9827|||||TWO_SIDED|90.0|1.6446|2.3904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||2.3904|1.6446|
91660454|NCT03161405|183216015|OTHER||Geometric mean ratio|1.2914|||||TWO_SIDED|90.0|1.1199|1.4891||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4891|1.1199|
91660455|NCT03161405|183216016|OTHER||Geometric mean ratio|1.2783|||||TWO_SIDED|90.0|1.0965|1.4904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4904|1.0965|
91524978|NCT05375955|182925307|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-10.8|0.2712
91524979|NCT05375955|182925307|OTHER||Risk Difference (RD)|25.5||||0.0056|TWO_SIDED|95.0|5.4|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|5.4|0.0056
91622018|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.73|-0.19|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.73|0.0008
91622019|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.0034|TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.77|0.0034
91622020|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.01|-0.39|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.01|<.0001
91622021|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.15||0.0361|TWO_SIDED|95.0|-0.59|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.59|0.0361
91524980|NCT05375955|182925307|OTHER||Risk Difference (RD)|30.6||||0.0017|TWO_SIDED|95.0|9.7|50.5|||Chan and Zhang (1999) method|||Week 10||50.5|9.7|0.0017
91524981|NCT05375955|182925307|OTHER||Risk Difference (RD)|3.4||||0.3929|TWO_SIDED|95.0|-14.9|21.6|||Chan and Zhang (1999) method|||Week 12||21.6|-14.9|0.3929
91524982|NCT05375955|182925307|OTHER||Risk Difference (RD)|28.2||||0.004|TWO_SIDED|95.0|7.0|47.7|||Chan and Zhang (1999) method|||Week 12||47.7|7.0|0.0040
91660456|NCT01597245|183216023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91524983|NCT05375955|182925307|OTHER||Risk Difference (RD)|33.7||||0.0012|TWO_SIDED|95.0|10.4|53.7|||Chan and Zhang (1999) method|||Week 12||53.7|10.4|0.0012
91524984|NCT05375955|182925310|OTHER||Risk Difference (RD)|2.8||||0.3255|TWO_SIDED|95.0|-8.5|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-8.5|0.3255
91660457|NCT01597245|183216023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660458|NCT01597245|183216023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660459|NCT01597245|183216024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660460|NCT01597245|183216024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660461|NCT01597245|183216024|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660462|NCT01597245|183216025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.005
91660463|NCT01597245|183216025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660464|NCT01597245|183216025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660465|NCT01597245|183216026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660466|NCT01597245|183216026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91622022|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2786|TWO_SIDED|95.0|-0.44|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.44|0.2786
91622023|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0058|TWO_SIDED|95.0|-0.68|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.68|0.0058
91622024|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.0365|TWO_SIDED|95.0|-0.71|-0.02|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.71|0.0365
91622025|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0092|TWO_SIDED|95.0|-0.8|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.80|0.0092
91622026|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.2923|TWO_SIDED|95.0|-0.49|0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.49|0.2923
91622027|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2231|TWO_SIDED|95.0|-0.51|0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.51|0.2231
91622028|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0724|TWO_SIDED|95.0|-0.6|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.60|0.0724
91622029|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.19||0.4776|TWO_SIDED|95.0|-0.5|0.23|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.50|0.4776
91622030|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.19||0.1482|TWO_SIDED|95.0|-0.64|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.64|0.1482
91622031|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.3249|TWO_SIDED|95.0|-0.56|0.18|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.56|0.3249
91622032|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1997|TWO_SIDED|95.0|-0.62|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.62|0.1997
91622033|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4823|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.53|0.4823
91622034|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2754|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2754
91622035|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5861|TWO_SIDED|95.0|-0.5|0.29|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.50|0.5861
91622036|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.4346|TWO_SIDED|95.0|-0.54|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.54|0.4346
91660467|NCT01597245|183216026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660468|NCT01597245|183216027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.008
91660469|NCT01597245|183216027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660470|NCT01597245|183216027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660471|NCT01597245|183216028|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91622037|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8752|TWO_SIDED|95.0|-0.42|0.36|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.36|-0.42|0.8752
91622038|NCT02528253|183137531|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.2||0.2663|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2663
91622039|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|TWO_SIDED|95.0|-0.77|-0.19|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.77|0.0013
91622040|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.28|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.87|0.0001
91622041|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2272|TWO_SIDED|95.0|-0.43|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.43|0.2272
91622042|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0209|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.58|0.0209
91622043|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.0029|TWO_SIDED|95.0|-0.67|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.67|0.0029
91622044|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.92|-0.28|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.92|0.0002
91622045|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.1|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.10|<.0001
91622046|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1198|TWO_SIDED|95.0|-0.53|0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.53|0.1198
91622047|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.016|TWO_SIDED|95.0|-0.66|-0.07|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.07|-0.66|0.0160
91622048|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.85|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.85|0.0003
91622049|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0091|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.77|0.0091
91622050|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.90|0.0007
91622051|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2264|TWO_SIDED|95.0|-0.48|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.48|0.2264
91660472|NCT01597245|183216028|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91660473|NCT01597245|183216029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91622052|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0961|TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.56|0.0961
91622053|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.15||0.0121|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0121
91622054|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.18||0.027|TWO_SIDED|95.0|-0.77|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.77|0.0270
91622055|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.0019|TWO_SIDED|95.0|-0.94|-0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.94|0.0019
91622056|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3906|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.48|0.3906
91622057|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.17||0.1209|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.59|0.1209
91622058|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.0107|TWO_SIDED|95.0|-0.76|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.76|0.0107
91622059|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.19||0.2396|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.61|0.2396
91622060|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1088|TWO_SIDED|95.0|-0.69|0.07|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.69|0.1088
91660474|NCT01597245|183216029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91660475|NCT01597245|183216029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91524985|NCT05375955|182925310|OTHER||Risk Difference (RD)|-2.5||||0.7181|TWO_SIDED|95.0|-13.3|8.3|||Chan and Zhang (1999) method|||Week 1||8.3|-13.3|0.7181
91524986|NCT05375955|182925310|OTHER||Risk Difference (RD)|18.4||||0.0022|TWO_SIDED|95.0|7.0|34.3|||Chan and Zhang (1999) method|||Week 2||34.3|7.0|0.0022
91622061|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1673|TWO_SIDED|95.0|-0.65|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.65|0.1673
91622062|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1751|TWO_SIDED|95.0|-0.66|0.12|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.66|0.1751
91622063|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3164|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3164
91660476|NCT01597245|183216030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660477|NCT01597245|183216030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660478|NCT01597245|183216030|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660479|NCT01597245|183216031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
91660480|NCT01597245|183216031|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660481|NCT01597245|183216031|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660482|NCT01597245|183216032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660483|NCT01597245|183216032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660484|NCT01597245|183216032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660485|NCT01597245|183216033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660486|NCT01597245|183216033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660487|NCT01597245|183216033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660488|NCT01597245|183216034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED||||||ANCOVA|||||||0.150
91660489|NCT01597245|183216034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
91660490|NCT01597245|183216034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91524987|NCT05375955|182925310|OTHER||Risk Difference (RD)|14.7||||0.0064|TWO_SIDED|95.0|3.7|31.1|||Chan and Zhang (1999) method|||Week 2||31.1|3.7|0.0064
91622064|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2253|TWO_SIDED|95.0|-0.62|0.15|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.62|0.2253
91622065|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3408|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3408
91622066|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3391|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3391
91622067|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5818|TWO_SIDED|95.0|-0.5|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.50|0.5818
91660491|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.026
91660492|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.076
91660493|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.016
91660494|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
91660495|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
91660496|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
91660497|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
91660498|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
91660499|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
91660500|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
91660501|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
91660502|NCT01597245|183216035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
91660503|NCT01597245|183216036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
91660504|NCT01597245|183216036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
91660505|NCT01597245|183216036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
91660506|NCT01597245|183216036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
91660507|NCT01597245|183216036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
91660508|NCT01597245|183216036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
91660509|NCT01597245|183216037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660510|NCT01597245|183216037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660511|NCT01597245|183216037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91660512|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
91660513|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
91660514|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
91660515|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
91660516|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
91660517|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
91660518|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||0.002
91660519|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
91622068|NCT02528253|183137533|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2562|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.62|0.2562
91622069|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.0137|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0137
91622070|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0044|TWO_SIDED|95.0|-0.76|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.76|0.0044
91660520|NCT01597245|183216038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
91660521|NCT00731783|183216040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||1|TWO_SIDED|95.0|0.54|1.97|||Fisher Exact|||||1.97|0.54|1.00
91660522|NCT00731783|183216041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.05|TWO_SIDED|95.0|1.03|4.55|||Fisher Exact|||||4.55|1.03|0.05
91660523|NCT00731783|183216042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.39|1.52|||Fisher Exact|||||1.52|0.39|0.49
91622071|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6194|TWO_SIDED|95.0|-0.35|0.21|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.35|0.6194
91622072|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0271|TWO_SIDED|95.0|-0.59|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.59|0.0271
91622073|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0085|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.66|0.0085
91622074|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.0027|TWO_SIDED|95.0|-0.87|-0.18|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.87|0.0027
91622075|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.44|-1.13|<.0001
91622076|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1859|TWO_SIDED|95.0|-0.54|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.54|0.1859
91622077|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.0573|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.63|0.0573
91622078|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0005|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.88|0.0005
91622079|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0841|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.66|0.0841
91622080|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0074|TWO_SIDED|95.0|-0.85|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.85|0.0074
91660524|NCT00731783|183216043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.28|TWO_SIDED|95.0|0.77|3.28|||Fisher Exact|||||3.28|0.77|0.28
91622081|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.316|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.49|0.3160
91660525|NCT00731783|183216044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.12|TWO_SIDED|95.0|0.23|1.16|||Fisher Exact|||||1.16|0.23|0.12
91660526|NCT00731783|183216045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.02|TWO_SIDED|95.0|0.21|0.85|||Fisher Exact|||||0.85|0.21|0.02
91660527|NCT00731783|183216046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.2|0.77|||Fisher Exact|||||0.77|0.20|0.008
91660528|NCT00731783|183216047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.02|TWO_SIDED|95.0|0.22|0.86|||Fisher Exact|||||0.86|0.22|0.02
91622082|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3763|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.47|0.3763
91622083|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0505|TWO_SIDED|95.0|-0.65|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-0.65|0.0505
91622084|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0118|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.88|0.0118
91622085|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0012|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.03|0.0012
91622086|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2966|TWO_SIDED|95.0|-0.54|0.17|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.54|0.2966
91660529|NCT02571907|183216048|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the primary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 91.2%, which was greater than the performance goal of 55%.|||
91524988|NCT05375955|182925310|OTHER||Risk Difference (RD)|13.7||||0.0659|TWO_SIDED|95.0|-3.4|31.5|||Chan and Zhang (1999) method|||Week 4||31.5|-3.4|0.0659
91524989|NCT05375955|182925310|OTHER||Risk Difference (RD)|19.4||||0.0189|TWO_SIDED|95.0|0.9|38.5|||Chan and Zhang (1999) method|||Week 4||38.5|0.9|0.0189
91524990|NCT05375955|182925310|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 6||22.3|-14.9|0.3962
91622087|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.66|0.0956
91622088|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0117|TWO_SIDED|95.0|-0.81|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.81|0.0117
91622089|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3732|TWO_SIDED|95.0|-0.57|0.21|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.57|0.3732
91622090|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.1922|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1922
91660530|NCT02571907|183216049|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the secondary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 70.8%, which was greater than the performance goal of 46%.|||
91660531|NCT03666026|183216058|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.03||||||||1.03|1.00|
91660532|NCT03666026|183216058|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
91524991|NCT05375955|182925310|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 6||29.1|-10.4|0.2333
91524992|NCT05375955|182925310|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 8||22.3|-14.9|0.3962
91524993|NCT05375955|182925310|OTHER||Risk Difference (RD)|11.9||||0.1353|TWO_SIDED|95.0|-7.9|32.7|||Chan and Zhang (1999) method|||Week 8||32.7|-7.9|0.1353
91660533|NCT03666026|183216058|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
91660534|NCT00579345|183216069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.66|||||TWO_SIDED|95.0|0.45|0.98|||||A/H1N1(Day22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||0.98|0.45|
91524994|NCT05375955|182925310|OTHER||Risk Difference (RD)|6.2||||0.2791|TWO_SIDED|95.0|-12.8|25.7|||Chan and Zhang (1999) method|||Week 10||25.7|-12.8|0.2791
91660535|NCT00579345|183216069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||A/H3N2 (Day 22)-criterion was met|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.19|0.55|
91660536|NCT00579345|183216069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.69|||||TWO_SIDED|95.0|0.46|1.02|||||B (Day 22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.02|0.46|
91660537|NCT01343004|183216070|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91660538|NCT01343004|183216070|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91660539|NCT01343004|183216071|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91713452|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.|Wilcoxon test|||||||0.36
91722469|NCT01932606|183337714|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in diastolic blood pressure.||||0.05
91660540|NCT01343004|183216071|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91660541|NCT01343004|183216071|SUPERIORITY_OR_OTHER|||||||0.8155|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.8155
91660542|NCT01343004|183216072|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91660543|NCT01343004|183216072|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91660544|NCT01343004|183216072|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91660545|NCT01343004|183216073|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91660546|NCT01343004|183216073|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
91660547|NCT01343004|183216073|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.0004
91660548|NCT01343004|183216074|SUPERIORITY_OR_OTHER|||||||0.0318|||||||Chi-squared|||||||0.0318
91660549|NCT01343004|183216074|SUPERIORITY_OR_OTHER|||||||0.2304|||||||Chi-squared|||||||0.2304
91660550|NCT01343004|183216074|SUPERIORITY_OR_OTHER|||||||0.3361|||||||Chi-squared|||||||0.3361
91660551|NCT00834067|183216098|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.7||||||90.0|90.1|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|90.1|
91622091|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2986|TWO_SIDED|95.0|-0.63|0.19|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.63|0.2986
91622092|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.21||0.2584|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.65|0.2584
91622093|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5195|TWO_SIDED|95.0|-0.57|0.29|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.57|0.5195
91622094|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.3752|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.60|0.3752
91622095|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5157|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5157
91622096|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.5065|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5065
91622097|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.21||0.8373|TWO_SIDED|95.0|-0.47|0.38|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.38|-0.47|0.8373
91622098|NCT02528253|183137535|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5146|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5146
91622099|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0059|TWO_SIDED|95.0|-0.76|-0.13|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.76|0.0059
91622100|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.93|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.93|0.0002
91622101|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0756|TWO_SIDED|95.0|-0.56|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.56|0.0756
91622102|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2197|TWO_SIDED|95.0|-0.47|0.11|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.47|0.2197
91622103|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.0208|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.63|0.0208
91722470|NCT01932606|183337715|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR after study drug (exercise)||||0.3
91622104|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
91622105|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
91622106|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1873|TWO_SIDED|95.0|-0.53|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.53|0.1873
91622107|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0305|TWO_SIDED|95.0|-0.66|-0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.66|0.0305
91660552|NCT00834067|183216099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.9|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|99.9|
91660553|NCT00834067|183216100|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|99.7|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|99.7|
91660554|NCT00834067|183216101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|96.0|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|96|
91660555|NCT00834067|183216102|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.1|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|99.1|
91713453|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8314||||||The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8314
91622108|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.2|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.20|-0.84|0.0013
91660556|NCT00834067|183216103|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.4|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|99.4|
91660557|NCT00834067|183216104|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|99.8|114.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||114|99.8|
91713454|NCT01519817|183318383|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
91524995|NCT05375955|182925310|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 10||29.1|-10.4|0.2333
91713455|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.64||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.|Wilcoxon test|||||||0.64
91524996|NCT05375955|182925310|OTHER||Risk Difference (RD)|11.3||||0.1295|TWO_SIDED|95.0|-7.3|30.6|||Chan and Zhang (1999) method|||Week 12||30.6|-7.3|0.1295
91660558|NCT00834067|183216105|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|99.0|106.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106|99|
91622109|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0158|TWO_SIDED|95.0|-0.78|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.78|0.0158
91622110|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.91|-0.21|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.91|0.0015
91622111|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.4173|TWO_SIDED|95.0|-0.45|0.19|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.45|0.4173
91622112|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0659|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0659
91622113|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.74|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.74|0.0078
91622114|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.0737|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.72|0.0737
91622115|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.97|0.0021
91622116|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4535|TWO_SIDED|95.0|-0.48|0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.48|0.4535
91660559|NCT00834067|183216106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|98.1|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|98.1|
91660560|NCT00418561|183216108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0737|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using analysis of variance (ANOVA) model including the baseline measurement as a covariate.||||0.0737
91524997|NCT05375955|182925310|OTHER||Risk Difference (RD)|20.3||||0.0247|TWO_SIDED|95.0|0.1|40.2|||Chan and Zhang (1999) method|||Week 12||40.2|0.1|0.0247
91660561|NCT00418561|183216109|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1115|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1115
91524998|NCT05375955|182925311|OTHER||Risk Difference (RD)|-4.3||||0.7278|TWO_SIDED|95.0|-21.9|11.5|||Chan and Zhang (1999) method|||Week 1||11.5|-21.9|0.7278
91524999|NCT05375955|182925311|OTHER||Risk Difference (RD)|8.2||||0.2548|TWO_SIDED|95.0|-11.5|28.2|||Chan and Zhang (1999) method|||Week 1||28.2|-11.5|0.2548
91622117|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.2271|TWO_SIDED|95.0|-0.56|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.56|0.2271
91622118|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0086|TWO_SIDED|95.0|-0.81|-0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.81|0.0086
91713456|NCT01519817|183318383|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.|Wilcoxon test|||||||0.30
91622119|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2243|TWO_SIDED|95.0|-0.63|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.63|0.2243
91622120|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0331|TWO_SIDED|95.0|-0.81|-0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.81|0.0331
91622121|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1838|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1838
91622122|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0795|TWO_SIDED|95.0|-0.75|0.04|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.75|0.0795
91622123|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2847|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.63|0.2847
91622124|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0745
91622125|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.311|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3110
91622126|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1375|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.70|0.1375
91622127|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.21||0.4036|TWO_SIDED|95.0|-0.58|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.58|0.4036
91622128|NCT02528253|183137537|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0641|TWO_SIDED|95.0|-0.79|0.02|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.79|0.0641
91622129|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.85|0.0037
91622130|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
91622131|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1712|TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.53|0.1712
91660562|NCT00418561|183216111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1268
91525000|NCT05375955|182925311|OTHER||Risk Difference (RD)|0.9||||0.5162|TWO_SIDED|95.0|-17.5|21.9|||Chan and Zhang (1999) method|||Week 1||21.9|-17.5|0.5162
91622132|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0686|TWO_SIDED|95.0|-0.6|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.60|0.0686
91622133|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0289|TWO_SIDED|95.0|-0.66|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.66|0.0289
91622134|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.30|-1.02|0.0003
91622135|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.22|-0.49|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.49|-1.22|<.0001
91622136|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2056|TWO_SIDED|95.0|-0.55|0.12|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.55|0.2056
91622137|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0084|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.78|0.0084
91622138|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.98|-0.31|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.31|-0.98|0.0002
91660563|NCT00829309|183216131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.45||||||90.0|80.08|121.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.03|80.08|
91660564|NCT00829309|183216132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|90.98||||||90.0|85.23|97.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.12|85.23|
91713457|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.|Wilcoxon test|||||||0.375
91525001|NCT05375955|182925311|OTHER||Risk Difference (RD)|9.3||||0.1663|TWO_SIDED|95.0|-11.4|30.7|||Chan and Zhang (1999) method|||Week 2||30.7|-11.4|0.1663
91660565|NCT00829309|183216133|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|96.3||||||90.0|85.34|108.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.66|85.34|
91622139|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.90|0.0063
91622140|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.09|-0.34|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.34|-1.09|0.0002
91622141|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1155|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.63|0.1155
91622142|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.1652|TWO_SIDED|95.0|-0.59|0.1|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.59|0.1652
91622143|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.0129|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.78|0.0129
91622144|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.0236|TWO_SIDED|95.0|-0.87|-0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.87|0.0236
91622145|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0136|TWO_SIDED|95.0|-0.93|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.93|0.0136
91622146|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6624|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.47|0.6624
91622147|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.19||0.0468|TWO_SIDED|95.0|-0.75|-0.01|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.75|0.0468
91622148|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.025|TWO_SIDED|95.0|-0.81|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.81|0.0250
91622149|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1539|TWO_SIDED|95.0|-0.72|0.11|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.72|0.1539
91525002|NCT05375955|182925311|OTHER||Risk Difference (RD)|16.5||||0.0605|TWO_SIDED|95.0|-4.2|38.3|||Chan and Zhang (1999) method|||Week 2||38.3|-4.2|0.0605
91525003|NCT05375955|182925311|OTHER||Risk Difference (RD)|16.7||||0.0592|TWO_SIDED|95.0|-5.4|41.6|||Chan and Zhang (1999) method|||Week 2||41.6|-5.4|0.0592
91622150|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0169|TWO_SIDED|95.0|-0.91|-0.09|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.91|0.0169
91622151|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.21||0.1049|TWO_SIDED|95.0|-0.77|0.07|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.77|0.1049
91660566|NCT03020615|183216167|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
91660567|NCT03020615|183216170|SUPERIORITY|||||||0.0005|||||||Exact Wilcoxon (Mann-Whitley), two-sided|||||||0.0005
91660568|NCT03020615|183216172|SUPERIORITY|||||||0.011|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.011
91660569|NCT03020615|183216173|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
91660570|NCT03020615|183216176|SUPERIORITY|||||||0.0009|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0009
91660571|NCT03020615|183216178|SUPERIORITY|||||||0.0004|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0004
91660572|NCT03020615|183216180|SUPERIORITY|||||||0.75|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.75
91660573|NCT03020615|183216182|SUPERIORITY|||||||0.0013|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0013
91660574|NCT03020615|183216183|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
91660575|NCT00089661|183216199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||<|0.0001||95.0|4.8|6.3|||ANCOVA|||||6.3|4.8|<0.0001
91660576|NCT02760368|183216205|SUPERIORITY||Risk Difference (RD)|0.378|||<|0.0001|TWO_SIDED|97.5|0.248|0.489|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q2w treatment group at Week 12 are expected to be at least 55%, resulting in an expected difference in ACR20 response rates of 30 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.489|0.248|<0.0001
91713458|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4808||||||The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4808
91660577|NCT02760368|183216205|SUPERIORITY||Risk Difference (RD)|0.445|||<|0.0001|TWO_SIDED|97.5|0.318|0.552|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q4w treatment group at Week 12 are expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 25 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.552|0.318|<0.0001
91660578|NCT02760368|183216206|SUPERIORITY||Risk Difference (RD)|0.294|||<|0.0001|TWO_SIDED|97.5|0.197|0.389|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 30% in 64 q2w OKZ treatment groups respectively, resulting in an expected difference of 20 percentage points between OKZ q2w treatment group and placebo.||0.389|0.197|<0.0001
91660579|NCT02760368|183216206|SUPERIORITY||Risk Difference (RD)|0.352|||<|0.0001|TWO_SIDED|97.5|0.251|0.449|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 22% in 64 mg q4w OKZ treatment group respectively, resulting in an expected difference of 12 percentage points between OKZ q4w treatment group and placebo.||0.449|0.251|<0.0001
91713459|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7334||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.|Wilcoxon test|||||||0.7334
91713460|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7109||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.|Wilcoxon|||||||0.7109
91525004|NCT05375955|182925311|OTHER||Risk Difference (RD)|14.0||||0.1246|TWO_SIDED|95.0|-8.6|37.4|||Chan and Zhang (1999) method|||Week 4||37.4|-8.6|0.1246
91525005|NCT05375955|182925311|OTHER||Risk Difference (RD)|16.3||||0.0789|TWO_SIDED|95.0|-7.3|39.7|||Chan and Zhang (1999) method|||Week 4||39.7|-7.3|0.0789
91525006|NCT05375955|182925311|OTHER||Risk Difference (RD)|17.6||||0.0889|TWO_SIDED|95.0|-6.4|43.7|||Chan and Zhang (1999) method|||Week 4||43.7|-6.4|0.0889
91660580|NCT02760368|183216207|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.47|-0.21|||ANCOVA|||||-0.21|-0.47|<0.0001
91660581|NCT02760368|183216207|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.49|-0.23|||ANCOVA|||||-0.23|-0.49|<0.0001
91660582|NCT02760368|183216208|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.0001|TWO_SIDED|97.5|0.239|0.45|||Chi-squared|2x2 chi-square test||||0.450|0.239|<0.0001
91660583|NCT02760368|183216208|SUPERIORITY||Risk Difference (RD)|0.409|||<|0.0001|TWO_SIDED|97.5|0.296|0.509|||Chi-squared|2x2 chi-square test||||0.509|0.296|<0.0001
91660584|NCT02760368|183216209|SUPERIORITY||Risk Difference (RD)|0.084|||<|0.0002|TWO_SIDED|97.5|0.032|0.151||2x2 chi-square test|Chi-squared|||||0.151|0.032|<0.0002
91660585|NCT02760368|183216209|SUPERIORITY||Risk Difference (RD)|0.077|||<|0.0003|TWO_SIDED|97.5|0.027|0.143||2x2 chi-square test|Chi-squared|||||0.143|0.027|<0.0003
91660586|NCT02129426|183216263|OTHER|t-test comparison of the two groups||||||0.96|||||||t-test, 1 sided|||||||0.96
91660587|NCT02129426|183216264|OTHER|||||||0.52|||||||t-test, 1 sided|||||||0.52
91660588|NCT00850174|183216266|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.48||||||90.0|88.98|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.00|88.98|
91660589|NCT00850174|183216267|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.54||||||90.0|99.19|106.01|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.01|99.19|
91660590|NCT00850174|183216268|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.19||||||90.0|98.78|105.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.71|98.78|
91660591|NCT00850174|183216269|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.77||||||90.0|97.03|104.65|||||Results presented for informational purposes only; metabolite not subjected to Bioequivalence criteria.|||104.65|97.03|
91660592|NCT00850174|183216270|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.94||||||90.0|97.75|102.18|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||102.18|97.75|
91660593|NCT00850174|183216271|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.8||||||90.0|97.5|102.15|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||102.15|97.50|
91660594|NCT00635492|183216273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.0001|TWO_SIDED|95.0|1.13|1.19|||Regression, Logistic|||Body Mass Index (BMI) - 1kg/m² higher||1.19|1.13|<0.0001
91660595|NCT00635492|183216274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Regression, Logistic|||Most recent HbA1c at baseline - 1% higher.||0.86|0.69|<0.0001
91660596|NCT00635492|183216275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||<|0.0001|TWO_SIDED|95.0|0.95|0.97|||Regression, Logistic|||Age - 1 year older||0.97|0.95|<0.0001
91660597|NCT00635492|183216276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0083|TWO_SIDED|95.0|1.01|1.1|||Regression, Logistic|||Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No||1.10|1.01|0.0083
91660598|NCT00635492|183216277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.0141|TWO_SIDED|95.0|0.9|0.99|||Regression, Logistic|||Random blood glucose - 1 mmol/L higher||0.99|0.90|0.0141
91660599|NCT00635492|183216278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.0107|TWO_SIDED|95.0|0.96|0.99|||Regression, Logistic|||Blood glucose self-monitoring - 1 test/week more||0.99|0.96|0.0107
91660600|NCT00635492|183216279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0193|TWO_SIDED|95.0|1.13|2.46|||Regression, Logistic|||Receipt of diet/exercise advice - Yes vs. No||2.46|1.13|0.0193
91660601|NCT00635492|183216280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.0138|TWO_SIDED|95.0|0.72|0.96|||Regression, Logistic|||LDL cholesterol - 1 mmol/L higher at baseline||0.96|0.72|0.0138
91660602|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118|||<|0.0001|TWO_SIDED|95.0|1.062|1.177|||Regression, Cox|||HbA1c (%) at baseline||1.177|1.062|<0.0001
91660603|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.001|TWO_SIDED|95.0|0.937|0.985|||Regression, Cox|||DHP barriers to activity subscale at baseline||0.985|0.937|0.001
91525007|NCT05375955|182925311|OTHER||Risk Difference (RD)|27.5||||0.0097|TWO_SIDED|95.0|4.2|50.7|||Chan and Zhang (1999) method|||Week 6||50.7|4.2|0.0097
91660604|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.532|||<|0.001|TWO_SIDED|95.0|1.698|3.777|||Regression, Cox|||Gastrointestinal symptoms: yes vs. no at baseline||3.777|1.698|<0.001
91660605|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.437|||<|0.001|TWO_SIDED|95.0|0.303|0.63|||Regression, Cox|||Insulin regimen: basal/bolus vs. long-acting only||0.630|0.303|<0.001
91660606|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.676||||0.003|TWO_SIDED|95.0|0.523|0.874|||Regression, Cox|||Insulin regimen: mixtures vs. long-acting only||0.874|0.523|0.003
91660607|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.303|TWO_SIDED|95.0|0.175|1.718|||Regression, Cox|||Insulin regimen: other vs. long-acting only||1.718|0.175|0.303
91660608|NCT00635492|183216288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.164|||<|0.001|TWO_SIDED|95.0|1.681|2.785|||Regression, Cox|||Insulin regimen: short-acting only vs. long-acting only||2.785|1.681|<0.001
91660609|NCT00635492|183216289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.463||||0.028|TWO_SIDED|95.0|1.043|2.053|||Regression, Cox|||GI symptoms: yes vs. no at baseline||2.053|1.043|0.028
91660610|NCT00635492|183216289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.002|TWO_SIDED|95.0|0.432|0.834|||Regression, Cox|||EQ-5D index value at baseline||0.834|0.432|0.002
91660611|NCT02757105|183216296|SUPERIORITY|||||||0.036|||||||Chi-squared, Corrected|||||||0.036
91660612|NCT02757105|183216297|SUPERIORITY|||||||0.41|||||||Chi-squared, Corrected|||||||0.410
91660613|NCT02757105|183216298|SUPERIORITY|||||||0.081|||||||Chi-squared, Corrected|||||||0.081
91660614|NCT02757105|183216299|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||||||0.042
91660615|NCT02757105|183216300|SUPERIORITY|||||||0.009|||||||Chi-squared, Corrected|||||||0.009
91660616|NCT02757105|183216301|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
91660617|NCT02757105|183216302|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.278|TWO_SIDED|95.0|-7.7|30.6|||Chi-squared, Corrected|||||30.6|-7.7|0.278
91660618|NCT02757105|183216303|SUPERIORITY||Mean Difference (Final Values)|14.5||||0.135|TWO_SIDED|95.0|-3.4|32.5|||Chi-squared, Corrected|||||32.5|-3.4|0.135
91660619|NCT02937870|183216308|OTHER||Least square (LS) mean difference|0.66||||0.177|TWO_SIDED|95.0|-0.14|1.47||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.47|-0.14|0.1770
91722471|NCT01932606|183337716|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PA compliance after study drug (exercise)||||0.3
91660620|NCT02937870|183216309|OTHER||LS mean difference|-0.2||||0.8321|TWO_SIDED|95.0|-0.98|0.59||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.59|-0.98|0.8321
91660621|NCT02937870|183216310|OTHER||LS mean difference|0.07||||0.8566|TWO_SIDED|95.0|-0.72|0.87|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.87|-0.72|0.8566
91660622|NCT02937870|183216311|OTHER||LS mean difference|-0.79||||0.0488|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||-0.00|-1.58|0.0488
91660623|NCT02937870|183216312|OTHER||LS mean difference|0.86||||0.0352|TWO_SIDED|95.0|0.06|1.66|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.66|0.06|0.0352
91660624|NCT00836056|183216334|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.75||||||90.0|91.5|104.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.42|91.50|
91660625|NCT00836056|183216335|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.77||||||90.0|91.4|102.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.46|91.40|
91660626|NCT00836056|183216336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|95.96||||||90.0|90.77|101.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.46|90.77|
91660627|NCT03226522|183216337|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
91660628|NCT03226522|183216337|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91660629|NCT01001208|183216338|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||<0.0001
91660630|NCT01001208|183216339|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
91660631|NCT01001208|183216340|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
91660632|NCT01001208|183216341|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
91622152|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0599|TWO_SIDED|95.0|-0.82|0.02|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.82|0.0599
91622153|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.3041|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.3041
91622154|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0737|TWO_SIDED|95.0|-0.83|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.83|0.0737
91622155|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.2293|TWO_SIDED|95.0|-0.71|0.17|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.71|0.2293
91622156|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.22||0.0806|TWO_SIDED|95.0|-0.82|0.05|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.82|0.0806
91622157|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.368|TWO_SIDED|95.0|-0.62|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.62|0.3680
91622158|NCT02528253|183137539|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.0893|TWO_SIDED|95.0|-0.79|0.06|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.79|0.0893
91622159|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.88|-0.24|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.88|0.0007
91622160|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.03|-0.38|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.38|-1.03|<.0001
91622161|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1291|TWO_SIDED|95.0|-0.53|0.07|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.53|0.1291
91622162|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.029|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.63|0.0290
91622163|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0015|TWO_SIDED|95.0|-0.77|-0.18|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.77|0.0015
91622164|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.87|0.0041
91622165|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.25|-0.54|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.54|-1.25|<.0001
91622166|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.1799|TWO_SIDED|95.0|-0.55|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.55|0.1799
91660633|NCT01001208|183216342|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
91622167|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0696|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0696
91622168|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
91622169|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.0387|TWO_SIDED|95.0|-0.74|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.74|0.0387
91622170|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-1.0|-0.28|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-1.00|0.0005
91622171|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2768|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.51|0.2768
91622172|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2408|TWO_SIDED|95.0|-0.53|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.53|0.2408
91622173|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.17||0.0064|TWO_SIDED|95.0|-0.78|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.78|0.0064
91622174|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.0115|TWO_SIDED|95.0|-0.9|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.90|0.0115
91622175|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0006|TWO_SIDED|95.0|-1.08|-0.29|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-1.08|0.0006
91622176|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.2028|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.59|0.2028
91622177|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1351|TWO_SIDED|95.0|-0.64|0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.64|0.1351
91622178|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0133|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.82|0.0133
91622179|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.2||0.2157|TWO_SIDED|95.0|-0.65|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.65|0.2157
91622180|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0781|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0781
91660634|NCT01001208|183216343|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
91660635|NCT01001208|183216344|SUPERIORITY_OR_OTHER|||||||0.0348||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0348
91660636|NCT01001208|183216345|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
91660637|NCT01001208|183216346|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
91660638|NCT01001208|183216347|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
91622181|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3527|TWO_SIDED|95.0|-0.62|0.22|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.62|0.3527
91622182|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2994|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2994
91622183|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3326|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.63|0.3326
91622184|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.2822|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.65|0.2822
91622185|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.22||0.4932|TWO_SIDED|95.0|-0.57|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.57|0.4932
91622186|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.22||0.4571|TWO_SIDED|95.0|-0.58|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-0.58|0.4571
91622187|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5586|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.56|0.5586
91622188|NCT02528253|183137541|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2664|TWO_SIDED|95.0|-0.67|0.19|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.67|0.2664
91622189|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|2.14||||0.001|TWO_SIDED|95.0|1.36|3.36|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.36|1.36|0.0010
91622190|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.0001|TWO_SIDED|95.0|1.73|4.16|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||4.16|1.73|<.0001
91622191|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.62||||0.03|TWO_SIDED|95.0|1.05|2.51|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.51|1.05|0.0300
91660639|NCT02648347|183216348|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.04|0.15||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.15|-0.04|
91525008|NCT05375955|182925311|OTHER||Risk Difference (RD)|20.7||||0.0294|TWO_SIDED|95.0|-0.8|43.6|||Chan and Zhang (1999) method|||Week 6||43.6|-0.8|0.0294
91525009|NCT05375955|182925311|OTHER||Risk Difference (RD)|37.8||||0.0018|TWO_SIDED|95.0|10.9|62.2|||Chan and Zhang (1999) method|||Week 6||62.2|10.9|0.0018
91713461|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4347||||||The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4347
91713462|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.|Wilcoxon|||||||>0.9999
91525010|NCT05375955|182925311|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|-3.8|0.0495
91525011|NCT05375955|182925311|OTHER||Risk Difference (RD)|7.6||||0.289|TWO_SIDED|95.0|-17.3|32.4|||Chan and Zhang (1999) method|||Week 8||32.4|-17.3|0.2890
91622192|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.44|2.86|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.86|1.44|<.0001
91622193|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|2.37|||<|0.0001|TWO_SIDED|95.0|1.69|3.32|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.32|1.69|<.0001
91622194|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.44||||0.029|TWO_SIDED|95.0|1.04|1.99|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.99|1.04|0.0290
91622195|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0003|TWO_SIDED|95.0|1.31|2.47|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.47|1.31|0.0003
91622196|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.62|3.03|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.03|1.62|<.0001
91622197|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0033|TWO_SIDED|95.0|1.16|2.1|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.10|1.16|0.0033
91622198|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0179|TWO_SIDED|95.0|1.06|1.88|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.88|1.06|0.0179
91622199|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0021|TWO_SIDED|95.0|1.18|2.08|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.08|1.18|0.0021
91622200|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6629|TWO_SIDED|95.0|0.81|1.38|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.38|0.81|0.6629
91622201|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0251|TWO_SIDED|95.0|1.04|1.75|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.75|1.04|0.0251
91622202|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1278|TWO_SIDED|95.0|0.94|1.59|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.59|0.94|0.1278
91622203|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.27||||0.0749|TWO_SIDED|95.0|0.98|1.65|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.65|0.98|0.0749
91622204|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0633|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.66|0.99|0.0633
91622205|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0626|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.67|0.99|0.0626
91622206|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2727|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.51|0.89|0.2727
91713463|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.748||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.|Wilcoxon test|||||||0.748
91525012|NCT05375955|182925311|OTHER||Risk Difference (RD)|35.2||||0.0103|TWO_SIDED|95.0|5.1|62.0|||Chan and Zhang (1999) method|||Week 8||62.0|5.1|0.0103
91525013|NCT05375955|182925311|OTHER||Risk Difference (RD)|19.0||||0.1088|TWO_SIDED|95.0|-7.8|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|-7.8|0.1088
91525014|NCT05375955|182925311|OTHER||Risk Difference (RD)|11.8||||0.2719|TWO_SIDED|95.0|-14.0|36.2|||Chan and Zhang (1999) method|||Week 10||36.2|-14.0|0.2719
91713464|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4.||||||0.8203
91622207|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1749|TWO_SIDED|95.0|0.92|1.57|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.57|0.92|0.1749
91622208|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5239|TWO_SIDED|95.0|0.84|1.42|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.42|0.84|0.5239
91713465|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5625||||||The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5625
91525015|NCT05375955|182925311|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 10||56.6|0.4|0.0227
91622209|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3336|TWO_SIDED|95.0|0.87|1.49|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.49|0.87|0.3336
91622210|NCT02528253|183137543|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2163|TWO_SIDED|95.0|0.91|1.54|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.54|0.91|0.2163
91622211|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.28||||0.326|TWO_SIDED|95.0|0.78|2.08|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.08|0.78|0.3260
91622212|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0445|TWO_SIDED|95.0|1.01|2.56|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.56|1.01|0.0445
91713466|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
91622213|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9263|TWO_SIDED|95.0|0.65|1.61|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.61|0.65|0.9263
91622214|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3194|TWO_SIDED|95.0|0.81|1.94|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.81|0.3194
91525016|NCT05375955|182925311|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 12||48.9|-3.8|0.0495
91622215|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0308|TWO_SIDED|95.0|1.04|2.38|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.38|1.04|0.0308
91622216|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0048|TWO_SIDED|95.0|1.2|2.69|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.69|1.20|0.0048
91525017|NCT05375955|182925311|OTHER||Risk Difference (RD)|15.9||||0.1246|TWO_SIDED|95.0|-10.6|40.6|||Chan and Zhang (1999) method|||Week 12||40.6|-10.6|0.1246
91525018|NCT05375955|182925311|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 12||56.6|0.4|0.0227
91622217|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0114|TWO_SIDED|95.0|1.12|2.51|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.51|1.12|0.0114
91660640|NCT02648347|183216349|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.205|TWO_SIDED|95.0|0.955|1.412|||Log Rank|||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.412|0.955|=0.2050
91722472|NCT01932606|183337717|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR after study drug (exercise).||||0.007
91622218|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7857|TWO_SIDED|95.0|0.71|1.56|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.71|0.7857
91525019|NCT01622010|182925367|EQUIVALENCE|P value 0.05 used||||||0.487|||||||Chi-squared|||||||0.487
91525020|NCT01622010|182925369|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|a non-inferiority margin calculation was not performed for this study prior to its start.||||||0.628|||||||Fisher Exact|||Null hypothesis: Standard care is better than standard care with video enhancement.||||0.628
91525021|NCT01622010|182925370|EQUIVALENCE|P Value 0.05 used||||||0.647|||||||Chi-squared|||||||0.647
91622219|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0041|TWO_SIDED|95.0|1.18|2.44|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.44|1.18|0.0041
91527721|NCT01976364|182930500|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91622220|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0109|TWO_SIDED|95.0|1.11|2.28|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.28|1.11|0.0109
91660641|NCT02648347|183216349|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
91713467|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
91622221|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0363|TWO_SIDED|95.0|1.03|2.27|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.27|1.03|0.0363
91527722|NCT01976364|182930501|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
91622222|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.76||||0.004|TWO_SIDED|95.0|1.2|2.59|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.59|1.20|0.0040
91622223|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1992|TWO_SIDED|95.0|0.88|1.84|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.84|0.88|0.1992
91622224|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3084|TWO_SIDED|95.0|0.85|1.7|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.70|0.85|0.3084
91622225|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0586|TWO_SIDED|95.0|0.99|1.94|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.99|0.0586
91622226|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.39||||0.063|TWO_SIDED|95.0|0.98|1.97|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.97|0.98|0.0630
91622227|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0347|TWO_SIDED|95.0|1.03|2.04|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.04|1.03|0.0347
91622228|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|0.96||||0.79|TWO_SIDED|95.0|0.69|1.33|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.33|0.69|0.7900
91622229|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0207|TWO_SIDED|95.0|1.06|2.0|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.00|1.06|0.0207
91622230|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0093|TWO_SIDED|95.0|1.11|2.07|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.07|1.11|0.0093
91622231|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.39||||0.04|TWO_SIDED|95.0|1.02|1.91|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.91|1.02|0.0400
91622232|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2478|TWO_SIDED|95.0|0.88|1.65|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.65|0.88|0.2478
91622233|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0304|TWO_SIDED|95.0|1.03|1.96|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.96|1.03|0.0304
91622234|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4763|TWO_SIDED|95.0|0.81|1.56|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.81|0.4763
91622235|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0178|TWO_SIDED|95.0|1.07|2.01|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.01|1.07|0.0178
91660642|NCT02648347|183216350|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.06|0.14||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.14|-0.06|
91660643|NCT02648347|183216351|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.1743|TWO_SIDED|95.0|0.966|1.382|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.382|0.966|=0.1743
91660644|NCT02648347|183216351|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
91622236|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5223|TWO_SIDED|95.0|0.8|1.53|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.53|0.80|0.5223
91622237|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1708|TWO_SIDED|95.0|0.91|1.72|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.72|0.91|0.1708
91525022|NCT03976466|182925394|SUPERIORITY||Risk Ratio (RR)|0.049|||<|0.05|TWO_SIDED|95.0|0.015|0.168|||Chi-squared, Corrected||For the Relative risk the control Study group was the numerator and control group denominator. In the 2X2 contingency table the rows correspond to groups and columns for the presence or abscence of periprosthetic infection.|"H0.- There is no significant difference in the incidence of periprosthetic infection in patients with non-modifiable risk factors and prophylactic application of antibiotic loaded calcium sulfate compared with patients without prophylactic treatment with calcium sulfate.~The presence of periprosthetic infection in both groups was evaluated by chi2 and Lambda tests for dichotomous nominal and qualitative variables with longitudinal direction and relative risk factor test."||0.168|0.015|<0.05
91713468|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14|Wilcoxon test|||||||0.5
91713469|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6846||||||The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6846
91713470|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
91713471|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.|Wilcoxon test|||||||0.5
91713472|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
91713473|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4375||||||The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4375
91713474|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
91713475|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
91713476|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.75||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.|Wilcoxon test|||||||0.75
91713477|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4525||||||The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.||||||0.4525
91713478|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|Wilcoxon test|||||||0.875
91713479|NCT01519817|183318384|NON_INFERIORITY|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.||||||0.4316|||||||Wilcoxon test|||Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||0.4316
91713480|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
91713481|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9906||||||The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.9906
91713482|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1.||||||0.625
91713483|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.791||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.|Wilcoxon test|||||||0.791
91713484|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.|Wilcoxon test|||||||0.8203
91713485|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||>0.9999
91713486|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.|Wilcoxon test|||||||0.875
91622238|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6022|TWO_SIDED|95.0|0.79|1.5|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.50|0.79|0.6022
91622239|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0846|TWO_SIDED|95.0|0.96|1.81|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.81|0.96|0.0846
91713487|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9658||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.|Wilcoxon test|||||||0.9658
91622240|NCT02528253|183137544|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9626|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.39|0.73|0.9626
91622241|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.64||0.6508|TWO_SIDED|95.0|-2.49|3.98|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.98|-2.49|0.6508
91713488|NCT01519817|183318384|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6523||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.|Wilcoxon test|||||||0.6523
91713489|NCT01519817|183318385|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2901||||||The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2901
91713490|NCT01519817|183318385|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.|Wilcoxon test|||||||0.375
91622242|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.66||0.9629|TWO_SIDED|95.0|-3.33|3.18|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.18|-3.33|0.9629
91622243|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.57||0.7007|TWO_SIDED|95.0|-2.48|3.69|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.69|-2.48|0.7007
91622244|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.58||0.8902|TWO_SIDED|95.0|-3.32|2.88|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.88|-3.32|0.8902
91622245|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.53||0.5698|TWO_SIDED|95.0|-3.89|2.15|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.15|-3.89|0.5698
91622246|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.8464|TWO_SIDED|95.0|-3.32|2.72|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.72|-3.32|0.8464
91622247|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-4.03|STANDARD_ERROR_OF_MEAN|2.39||0.0919|TWO_SIDED|95.0|-8.72|0.66|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.66|-8.72|0.0919
91622248|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|2.4||0.0477|TWO_SIDED|95.0|-9.47|-0.05|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-9.47|0.0477
91622249|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|2.3||0.4735|TWO_SIDED|95.0|-6.17|2.87|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.87|-6.17|0.4735
91622250|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.26||0.2935|TWO_SIDED|95.0|-6.82|2.06|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.06|-6.82|0.2935
91622251|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-3.11|STANDARD_ERROR_OF_MEAN|2.27||0.1714|TWO_SIDED|95.0|-7.56|1.35|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.35|-7.56|0.1714
91622252|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|2.75||0.7521|TWO_SIDED|95.0|-6.3|4.56|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.56|-6.30|0.7521
91622253|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|2.75||0.3078|TWO_SIDED|95.0|-8.24|2.61|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.61|-8.24|0.3078
91622254|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-3.95|STANDARD_ERROR_OF_MEAN|2.46||0.109|TWO_SIDED|95.0|-8.78|0.88|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.88|-8.78|0.1090
91622255|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-5.41|STANDARD_ERROR_OF_MEAN|2.47||0.0289|TWO_SIDED|95.0|-10.27|-0.56|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-10.27|0.0289
91622256|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.37||0.4613|TWO_SIDED|95.0|-6.41|2.91|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.91|-6.41|0.4613
91713491|NCT01519817|183318385|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2036||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.|Wilcoxon test|||||||0.2036
91525023|NCT03976466|182925395|SUPERIORITY||||||<|0.01||||||The statistical test of t was performed for the variable length of hospital stay, finding a significant difference with a p value \< 0.01|t-test, 2 sided|||Lenght of stay was the variable that compares both groups and was a continous variable (t-test).||||<0.01
91660645|NCT02648347|183216352|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.19|||=|0.3154|TWO_SIDED|95.0|0.901|1.564|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.564|0.901|=0.3154
91713492|NCT01519817|183318385|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0742||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.|Wilcoxon test|||||||0.0742
91622257|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|2.33||0.346|TWO_SIDED|95.0|-6.78|2.38|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.38|-6.78|0.3460
91722473|NCT01932606|183337718|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW after study drug (exercise)||||0.0003
91622258|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|2.34||0.1179|TWO_SIDED|95.0|-8.26|0.93|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.93|-8.26|0.1179
91622259|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|2.97||0.5151|TWO_SIDED|95.0|-7.78|3.92|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.92|-7.78|0.5151
91660646|NCT02648347|183216352|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
91622260|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|2.96||0.255|TWO_SIDED|95.0|-9.22|2.46|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.46|-9.22|0.2550
91622261|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0157|TWO_SIDED|95.0|-7.57|-0.79|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.79|-7.57|0.0157
91622262|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0159|TWO_SIDED|95.0|-7.57|-0.78|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.78|-7.57|0.0159
91622263|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.62||0.0896|TWO_SIDED|95.0|-5.94|0.43|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.43|-5.94|0.0896
91722474|NCT01932606|183337719|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in oxygen consumption (VO\_2) after study drug (exercise).||||0.02
91525024|NCT02247336|182925397|SUPERIORITY||Odds Ratio (OR)|0.7||||0.16|TWO_SIDED|95.0|0.4|1.2||A priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|Using alpha=0.05, 80% power, and a risk-appropriate screening referral rate for the delayed arm ranging from 60% to 70%, n = 250 participants with a completed a family health history assessment per arm with 40 providers was needed to detect differences between arms in appropriate referral ranging from 12% to 13.2%. Sample size calculations accounted for provider clustering using an intra-class correlation coefficient of 0.02 to adjust variance for a Z-test of the difference of two proportions.||1.2|0.4|0.16
91622264|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.6||0.3749|TWO_SIDED|95.0|-4.57|1.72|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.72|-4.57|0.3749
91525025|NCT02247336|182925398|SUPERIORITY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.04|1.2||The a priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|||1.2|.04|0.23
91525026|NCT00733499|182925400|OTHER|||||||0.9478|||||||t-test, 2 sided|||||||0.9478
91525027|NCT00733499|182925401|OTHER|||||||0.549|||||||t-test, 2 sided|||||||0.5490
91525028|NCT00733499|182925402|OTHER|||||||0.5312|||||||t-test, 2 sided|||||||0.5312
91525029|NCT00733499|182925403|OTHER|||||||0.3549|||||||t-test, 2 sided|||||||0.3549
91525030|NCT00733499|182925404|OTHER|||||||0.0513|||||||t-test, 2 sided|||||||0.0513
91622265|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.59||0.3733|TWO_SIDED|95.0|-4.55|1.71|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.71|-4.55|0.3733
91622266|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|2.17||0.8056|TWO_SIDED|95.0|-4.8|3.73|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.73|-4.80|0.8056
91622267|NCT02528253|183137548|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|2.08||0.5764|TWO_SIDED|95.0|-5.25|2.93|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.93|-5.25|0.5764
91722475|NCT01932606|183337720|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in arteriovenous oxygen difference after study drug (exercise).||||0.6
91525031|NCT00733499|182925405|OTHER|||||||0.0629|||||||t-test, 2 sided|||||||0.0629
91525032|NCT00733499|182925406|OTHER|||||||0.0327|||||||t-test, 2 sided|||||||0.0327
91525033|NCT00733499|182925407|OTHER|||||||0.0883|||||||t-test, 2 sided|||||||0.0883
91525034|NCT00733499|182925408|OTHER|||||||0.6801|||||||Wilcoxon (Mann-Whitney)|||||||0.6801
91525035|NCT00733499|182925409|OTHER|||||||0.4779|||||||t-test, 2 sided|||||||0.4779
91525036|NCT00733499|182925410|OTHER|||||||0.8007|||||||t-test, 2 sided|||||||0.8007
91622268|NCT02528253|183137549|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7366|TWO_SIDED|95.0|0.62|1.41|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.41|0.62|0.7366
91622269|NCT02528253|183137549|SUPERIORITY||Odds Ratio (OR)|1.06||||0.771|TWO_SIDED|95.0|0.71|1.58|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.71|0.7710
91660647|NCT02648347|183216353|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.13|||=|0.5991|TWO_SIDED|95.0|0.808|1.594|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.594|0.808|=0.5991
91660648|NCT02648347|183216353|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
91660649|NCT02648347|183216354|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.4388|TWO_SIDED|95.0|0.902|1.375|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.375|0.902|=0.4388
91660650|NCT02648347|183216354|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
91525037|NCT00733499|182925411|OTHER|||||||0.3317|||||||t-test, 2 sided|||||||0.3317
91525038|NCT00733499|182925412|OTHER|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
91525039|NCT00733499|182925413|OTHER|||||||0.2116|||||||t-test, 2 sided|||||||0.2116
91525040|NCT00733499|182925414|OTHER|||||||0.4776|||||||t-test, 2 sided|||||||0.4776
91525041|NCT00733499|182925416|OTHER|||||||0.2935|||||||t-test, 2 sided|||||||0.2935
91525042|NCT00733499|182925417|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
91525043|NCT00733499|182925418|OTHER|||||||0.6896|||||||t-test, 2 sided|||||||0.6896
91622270|NCT02528253|183137550|SUPERIORITY|||||||0.4724|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.4724
91622271|NCT02528253|183137550|SUPERIORITY|||||||0.7142|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.7142
91722476|NCT01932606|183337721|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output after study drug (exercise).||||0.002
91525044|NCT00733499|182925419|OTHER|||||||0.1076|||||||t-test, 2 sided|||||||0.1076
91525045|NCT00733499|182925420|OTHER|||||||0.9042|||||||t-test, 2 sided|||||||0.9042
91525046|NCT00733499|182925421|OTHER|||||||0.9637|||||||t-test, 2 sided|||||||0.9637
91525047|NCT00733499|182925422|OTHER|||||||0.0485|||||||t-test, 2 sided|||||||0.0485
91525048|NCT00733499|182925423|OTHER|||||||0.9813|||||||t-test, 2 sided|||||||0.9813
91622272|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.12||||0.396|TWO_SIDED|95.0|0.87|1.44|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.87|0.3960
91622273|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5932|TWO_SIDED|95.0|0.73|1.2|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.20|0.73|0.5932
91622274|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3326|TWO_SIDED|95.0|0.88|1.46|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.46|0.88|0.3326
91622275|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.84||||0.1765|TWO_SIDED|95.0|0.65|1.08|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.08|0.65|0.1765
91622276|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5619|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.39|0.84|0.5619
91622277|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3909|TWO_SIDED|95.0|0.69|1.16|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.16|0.69|0.3909
91622278|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7562|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7562
91622279|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9476|TWO_SIDED|95.0|0.78|1.31|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.31|0.78|0.9476
91660651|NCT01639222|183216365|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|179.72|||||TWO_SIDED|95.0|157.16|205.52|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio \* 100%.|The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.||205.52|157.16|
91660652|NCT01639222|183216366|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|71.77|||||TWO_SIDED|95.0|68.83|74.84|||||Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio \* 100%.|||74.84|68.83|
91525049|NCT00733980|182925427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2479||||0.703||80.0|-0.5887|1.0846|||Mixed-Model Repeated-Measure analysis|||||1.0846|-0.5887|0.703
91622280|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7746|TWO_SIDED|95.0|0.79|1.36|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.36|0.79|0.7746
91622281|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.94||||0.6377|TWO_SIDED|95.0|0.71|1.23|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.23|0.71|0.6377
91622282|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8532|TWO_SIDED|95.0|0.79|1.33|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.79|0.8532
91622283|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5644|TWO_SIDED|95.0|0.83|1.4|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.40|0.83|0.5644
91622284|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.04||||0.769|TWO_SIDED|0.769|0.8|1.35|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7690
91622285|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4321|TWO_SIDED|95.0|0.85|1.44|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.85|0.4321
91622286|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7714|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7714
91660653|NCT01639222|183216367|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|156.74|||||TWO_SIDED|95.0|121.66|201.93|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio \* 100%.|||201.93|121.66|
91660654|NCT01723397|183216374|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon signed-rank test|||||||0.8
91622287|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8389|TWO_SIDED|95.0|0.79|1.34|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.34|0.79|0.8389
91660655|NCT03686033|183216426|SUPERIORITY||LS Mean difference|1.12|||||TWO_SIDED|90.0|-0.98|3.22||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. Least Square (LS) Mean Difference was calculated for 2.5 mg versus (vs) Placebo only.||3.22|-0.98|
91622288|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9383|TWO_SIDED|95.0|0.76|1.29|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.29|0.76|0.9383
91622289|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.78|1.33|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.78|0.8800
91525050|NCT00733980|182925428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0169||||0.966|TWO_SIDED|80.0|-0.5231|0.4893|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 1||0.4893|-0.5231|0.966
91622290|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7946|TWO_SIDED|95.0|0.74|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.26|0.74|0.7946
91622291|NCT02528253|183137551|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7803|TWO_SIDED|95.0|0.74|1.25|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.25|0.74|0.7803
91622292|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.1272|TWO_SIDED|95.0|0.96|1.41|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.41|0.96|0.1272
91722477|NCT01932606|183337722|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume after study drug (exercise).||||0.0002
91713493|NCT01519817|183318386|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1004||||||The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.1004
91525051|NCT00733980|182925428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4299||||0.386|TWO_SIDED|80.0|-0.2063|1.0661|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 2||1.0661|-0.2063|0.386
91713494|NCT01519817|183318386|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.625
91622293|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.1||0.6322|TWO_SIDED|95.0|0.86|1.27|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.86|0.6322
91622294|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.12||0.3559|TWO_SIDED|95.0|0.89|1.36|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.36|0.89|0.3559
91622295|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.96||||0.6798|TWO_SIDED|95.0|0.77|1.18|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.18|0.77|0.6798
91622296|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.14||||0.267|TWO_SIDED|95.0|0.9|1.44|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.44|0.90|0.2670
91622297|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.94||||0.5865|TWO_SIDED|95.0|0.74|1.19|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.19|0.74|0.5865
91622298|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.13||||0.3378|TWO_SIDED|95.0|0.88|1.47|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.47|0.88|0.3378
91622299|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.92||||0.551|TWO_SIDED|95.0|0.71|1.2|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.71|0.5510
91622300|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.18||0.2088|TWO_SIDED|95.0|0.9|1.6|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.90|0.2088
91660656|NCT03686033|183216426|SUPERIORITY||LS Mean difference|-4.17|||||TWO_SIDED|90.0|-6.35|-1.99||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. LS Mean Difference was calculated for 25 mg vs Placebo only.||-1.99|-6.35|
91660657|NCT01302548|183216446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0833|STANDARD_DEVIATION|0.8609||0.797|TWO_SIDED|95.0|-0.5738|0.7405||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 28||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||.7405|-.5738|.7970
91660658|NCT01302548|183216447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2364||||0.3575|TWO_SIDED|95.0|0.0239|2.3394||This is unadjusted.|Fisher Exact|Cell (1,1) Frequency (F) = 13||"Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||2.3394|.0239|.3575
91622301|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8692|TWO_SIDED|95.0|0.73|1.3|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.30|0.73|0.8692
91622302|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.03|STANDARD_ERROR_OF_MEAN|0.14||0.8444|TWO_SIDED|95.0|0.78|1.35|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.35|0.78|0.8444
91622303|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8936|TWO_SIDED|95.0|0.78|1.34|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.78|0.8936
91660659|NCT01302548|183216448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5477||0.5415|TWO_SIDED|95.0|-2.0659|1.2659||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 4||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power."||1.2659|-2.0659|.5415
91713495|NCT01519817|183318386|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6772||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.6772
91622304|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8716|TWO_SIDED|95.0|0.75|1.28|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.28|0.75|0.8716
91622305|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8827|TWO_SIDED|95.0|0.75|1.29|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.29|0.75|0.8827
91622306|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8996|TWO_SIDED|95.0|0.77|1.34|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.77|0.8996
91622307|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.488|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.4880
91622308|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.14||0.7938|TWO_SIDED|95.0|0.73|1.27|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.73|0.7938
91622309|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.5092|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.5092
91622310|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.6148|TWO_SIDED|95.0|0.71|1.22|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.22|0.71|0.6148
91622311|NCT02528253|183137553|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.12||0.2844|TWO_SIDED|95.0|0.66|1.13|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.13|0.66|0.2844
91660660|NCT00913627|183216451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|||<|0.001|TWO_SIDED|95.0|12.13|20.19||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.19|12.13|<0.001
91660661|NCT00913627|183216451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||<|0.001|TWO_SIDED|95.0|13.02|20.99||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.99|13.02|<0.001
91660662|NCT00913627|183216451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|8.33|16.26||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||16.26|8.33|<0.001
91660663|NCT00913627|183216452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34|||<|0.001|TWO_SIDED|95.0|4.3|8.38||p-value adjusted for baseline PSR and gender|ANOVA|||||8.38|4.30|<0.001
91660664|NCT00913627|183216452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|||<|0.001|TWO_SIDED|95.0|5.05|9.08||p-value adjusted for baseline PSR and gender|ANOVA|||||9.08|5.05|<0.001
91525052|NCT00733980|182925428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9413||||0.095|TWO_SIDED|80.0|0.2203|1.6624|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 4||1.6624|0.2203|0.095
91622312|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.25||0.6764|TWO_SIDED|95.0|0.7|1.73|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.73|0.70|0.6764
91622313|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.23||0.9351|TWO_SIDED|95.0|0.65|1.6|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.65|0.9351
91622314|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.2||0.8731|TWO_SIDED|95.0|0.64|1.46|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.64|0.8731
91622315|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|0.75|1.72|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.72|0.75|0.5370
91660665|NCT00913627|183216452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.05|||<|0.001|TWO_SIDED|95.0|3.04|7.06||p-value adjusted for baseline PSR and gender|ANOVA|||||7.06|3.04|<0.001
91660666|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-55.83|-88.56|<0.001
91660667|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-54.30|-87.14|<0.001
91660668|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-59.6|||<|0.001|TWO_SIDED|95.0|-76.94|-42.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-42.27|-76.94|<0.001
91660669|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-55.83|-88.56|<0.001
91660670|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-54.30|-87.14|<0.001
91660671|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-57.79|||<|0.001|TWO_SIDED|95.0|-75.43|-40.16||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-40.16|-75.43|<0.001
91660672|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-66.79|||<|0.001|TWO_SIDED|95.0|-83.98|-49.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-49.60|-83.98|<0.001
91622316|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.22||0.8031|TWO_SIDED|95.0|0.7|1.59|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.59|0.70|0.8031
91622317|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.24||0.8192|TWO_SIDED|95.0|0.57|1.55|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.55|0.57|0.8192
91622318|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.6345|TWO_SIDED|95.0|0.54|1.46|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.54|0.6345
91622319|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.21||0.6103|TWO_SIDED|95.0|0.56|1.4|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.40|0.56|0.6103
91622320|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.25||0.7949|TWO_SIDED|95.0|0.67|1.67|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.67|0.7949
91622321|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.23||0.992|TWO_SIDED|95.0|0.63|1.57|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.57|0.63|0.9920
91622322|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.27||0.8772|TWO_SIDED|95.0|0.55|1.67|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.55|0.8772
91622323|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7614|TWO_SIDED|95.0|0.53|1.6|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.53|0.7614
91622324|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.22||0.5629|TWO_SIDED|95.0|0.52|1.43|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.43|0.52|0.5629
91622325|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.29||0.6821|TWO_SIDED|95.0|0.67|1.85|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.85|0.67|0.6821
91622326|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.28||0.8049|TWO_SIDED|95.0|0.64|1.77|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.77|0.64|0.8049
91622327|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.27||0.6673|TWO_SIDED|95.0|0.47|1.62|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.62|0.47|0.6673
91622328|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.25||0.4475|TWO_SIDED|95.0|0.43|1.46|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.43|0.4475
91622329|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.25||0.5925|TWO_SIDED|95.0|0.49|1.5|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.50|0.49|0.5925
91525053|NCT00733980|182925429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9495||||0.209|TWO_SIDED|80.0|-0.0185|1.9175|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.9175|-0.0185|0.209
91622330|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.29||0.9486|TWO_SIDED|95.0|0.58|1.79|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.79|0.58|0.9486
91622331|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7673|TWO_SIDED|95.0|0.52|1.61|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.61|0.52|0.7673
91622332|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.39||0.7635|TWO_SIDED|95.0|0.56|2.2|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.20|0.56|0.7635
91622333|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.34||0.9564|TWO_SIDED|95.0|0.5|1.94|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.94|0.50|0.9564
91622334|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.3||0.8359|TWO_SIDED|95.0|0.5|1.75|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.75|0.50|0.8359
91622335|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.38||0.5914|TWO_SIDED|95.0|0.64|2.21|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.21|0.64|0.5914
91622336|NCT02528253|183137555|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.33||0.8826|TWO_SIDED|95.0|0.56|1.95|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.95|0.56|0.8826
91622337|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|7.02|STANDARD_ERROR_OF_MEAN|2.01||0.0005|TWO_SIDED|95.0|3.07|10.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.97|3.07|0.0005
91660673|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-54.30|-87.14|<0.001
91660674|NCT00913627|183216455|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-38.11|-73.85|<0.001
91622338|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|2.01||0.0021|TWO_SIDED|95.0|2.26|10.15|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.15|2.26|0.0021
91622339|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|4.72|STANDARD_ERROR_OF_MEAN|1.89||0.0125|TWO_SIDED|95.0|1.02|8.42|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.42|1.02|0.0125
91660675|NCT00913627|183216455|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-46.06|-80.82|<0.001
91660676|NCT00913627|183216455|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-68.88|||<|0.001|TWO_SIDED|95.0|-85.63|-54.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-54.14|-85.63|<0.001
91525054|NCT00733980|182925429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7638||||0.409|TWO_SIDED|80.0|-0.4243|1.9519|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||1.9519|-0.4243|0.409
91622340|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.87||0.2176|TWO_SIDED|95.0|-1.36|5.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|-1.36|0.2176
91622341|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|1.86||0.4235|TWO_SIDED|95.0|-2.16|5.14|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.14|-2.16|0.4235
91622342|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.96||0.0143|TWO_SIDED|95.0|2.5|22.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.11|2.50|0.0143
91622343|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|12.55|STANDARD_ERROR_OF_MEAN|4.96||0.0124|TWO_SIDED|95.0|2.76|22.35|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.35|2.76|0.0124
91660677|NCT00913627|183216455|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-38.11|-73.85|<0.001
91660678|NCT00913627|183216455|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-46.06|-80.82|<0.001
91622344|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|3.88|STANDARD_ERROR_OF_MEAN|4.29||0.3675|TWO_SIDED|95.0|-4.6|12.36|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||12.36|-4.60|0.3675
91660679|NCT00913627|183216455|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-65.28|||<|0.001|TWO_SIDED|95.0|-82.49|-48.07||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-48.07|-82.49|<0.001
91660680|NCT00913627|183216455|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-50.77|||<|0.001|TWO_SIDED|95.0|-69.09|-32.45||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-32.45|-69.09|<0.001
91660681|NCT00913627|183216456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34|||<|0.001|TWO_SIDED|95.0|4.18|6.51||p-value adjusted for baseline PSR, and gender|ANOVA|||SPID 0-4||6.51|4.18|<0.001
91660682|NCT00913627|183216456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.001|TWO_SIDED|95.0|4.09|6.4||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||6.40|4.09|<0.001
91660683|NCT00913627|183216456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.83|5.12||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||5.12|2.83|<0.001
91660684|NCT00913627|183216456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.53|||<|0.001|TWO_SIDED|95.0|5.63|9.43||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.43|5.63|<0.001
91525055|NCT00733980|182925429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5363||||0.156|TWO_SIDED|80.0|0.1485|2.9241|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9241|0.1485|0.156
91525056|NCT00733980|182925429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6327||||0.599|TWO_SIDED|80.0|-0.9135|2.1789|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.1789|-0.9135|0.599
91525057|NCT00733980|182925430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9866||||0.181|TWO_SIDED|80.0|-3.8876|-0.0856|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||-0.0856|-3.8876|0.181
91525058|NCT00733980|182925430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2538||||0.889|TWO_SIDED|80.0|-2.5922|2.0846|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.0846|-2.5922|0.889
91622345|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|8.42|STANDARD_ERROR_OF_MEAN|3.89||0.0319|TWO_SIDED|95.0|0.74|16.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.11|0.74|0.0319
91622346|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|8.67|STANDARD_ERROR_OF_MEAN|3.9||0.0276|TWO_SIDED|95.0|0.97|16.38|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.38|0.97|0.0276
91622347|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|1.38||0.0627|TWO_SIDED|95.0|-0.14|5.27|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.27|-0.14|0.0627
91622348|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.38||0.0187|TWO_SIDED|95.0|0.54|5.97|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|0.54|0.0187
91622349|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.3||0.2419|TWO_SIDED|95.0|-1.03|4.06|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.06|-1.03|0.2419
91622350|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.28||0.4124|TWO_SIDED|95.0|-1.46|3.56|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||3.56|-1.46|0.4124
91791879|NCT00329901|183461314|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-3.0|||||TWO_SIDED|95.0|-9.0|3.0||||||Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||3|-9|
91525059|NCT00733980|182925430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3242||||0.867|TWO_SIDED|80.0|-2.8165|2.1681|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 3||2.1681|-2.8165|0.867
91525060|NCT00733980|182925430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8107||||0.721|TWO_SIDED|80.0|-2.1036|3.7251|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||3.7251|-2.1036|0.721
91525061|NCT00733980|182925430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6273||||0.801|TWO_SIDED|80.0|-3.8337|2.5791|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.5791|-3.8337|0.801
91622351|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|1.27||0.173|TWO_SIDED|95.0|-0.76|4.24|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.24|-0.76|0.1730
91622352|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|5.42|STANDARD_ERROR_OF_MEAN|1.86||0.0037|TWO_SIDED|95.0|1.77|9.08|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||9.08|1.77|0.0037
91622353|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|1.86||0.0449|TWO_SIDED|95.0|0.09|7.39|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||7.39|0.09|0.0449
91622354|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|1.75||0.2038|TWO_SIDED|95.0|-1.21|5.65|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.65|-1.21|0.2038
91622355|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.73||0.0644|TWO_SIDED|95.0|-0.19|6.59|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.59|-0.19|0.0644
91622356|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.72||0.3775|TWO_SIDED|95.0|-1.86|4.9|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.90|-1.86|0.3775
91622357|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.62||0.5806|TWO_SIDED|95.0|-3.7|6.6|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.60|-3.70|0.5806
91622358|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.53||0.6084|TWO_SIDED|95.0|-3.68|6.27|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.27|-3.68|0.6084
91622359|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|6.95||0.6991|TWO_SIDED|95.0|-11.56|16.99|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.99|-11.56|0.6991
91622360|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|5.6||0.0265|TWO_SIDED|95.0|1.66|24.68|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||24.68|1.66|0.0265
91525062|NCT00733980|182925431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.644||||0.355|TWO_SIDED|80.0|-0.2498|1.5378|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.5378|-0.2498|0.355
91525063|NCT00733980|182925431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0524||||0.249|TWO_SIDED|80.0|-0.1194|2.2243|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.2243|-0.1194|0.249
91525064|NCT00733980|182925431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6473||||0.116|TWO_SIDED|80.0|0.3078|2.9868|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9868|0.3078|0.116
91622361|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.99||0.8795|TWO_SIDED|95.0|-3.61|4.21|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.21|-3.61|0.8795
91622362|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.2758|TWO_SIDED|95.0|-1.68|5.87|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.87|-1.68|0.2758
91622363|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|3.54|STANDARD_ERROR_OF_MEAN|2.27||0.1197|TWO_SIDED|95.0|-0.92|8.0|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.00|-0.92|0.1197
91525065|NCT00733980|182925431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7283||||0.55|TWO_SIDED|80.0|-0.8353|2.292|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.2920|-0.8353|0.550
91525066|NCT00733980|182925435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6359||||0.3588|TWO_SIDED|80.0|0.3378|1.1968|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 2||1.1968|0.3378|0.3588
91525067|NCT00733980|182925435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7347||||0.4088|TWO_SIDED|80.0|0.4554|1.1853|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 4||1.1853|0.4554|0.4088
91525068|NCT00733980|182925435|SUPERIORITY_OR_OTHER||Logistic Model|0.9211||||0.8156|TWO_SIDED|80.0|0.5863|1.4471|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal||1.4471|0.5863|0.8156
91525069|NCT00733980|182925436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4466||||0.361|TWO_SIDED|80.0|-1.3986|8.2917|||ANCOVA|||||8.2917|-1.3986|0.361
91525070|NCT00733980|182925437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1167||||0.932|TWO_SIDED|80.0|-1.6387|1.8722|||ANCOVA|||||1.8722|-1.6387|0.932
91525071|NCT01986101|182925453|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.007|TWO_SIDED|95.0|-4.9|-1.0||Hochberg-adjusted|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-1.0|-4.9|0.007
91622364|NCT02528253|183137564|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.19||0.0743|TWO_SIDED|95.0|-0.39|8.24|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.24|-0.39|0.0743
91622365|NCT01546285|183137585|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|4.8|||TWO_SIDED|95.0|-2.58|-0.22|||Compare the mean difference with 5mmHg|||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.||-0.22|-2.58|
91622366|NCT01546285|183137585|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|2.6|||TWO_SIDED|95.0|-3.95|-2.66||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.66|-3.95|
91660685|NCT00913627|183216456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68|||<|0.001|TWO_SIDED|95.0|5.8|9.56||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.56|5.80|<0.001
91660686|NCT00913627|183216456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|||<|0.001|TWO_SIDED|95.0|3.62|7.36||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||7.36|3.62|<0.001
91713496|NCT01519817|183318386|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
91713497|NCT01519817|183318387|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0621||||||The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0621
91713498|NCT01519817|183318387|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.875
91713499|NCT01519817|183318387|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2402||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.2402
91713500|NCT01519817|183318387|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
91713501|NCT03143257|183318406|SUPERIORITY||Mean Difference (Net)|38.0|STANDARD_DEVIATION|16.1|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91713502|NCT03143257|183318406|SUPERIORITY||Mean Difference (Net)|43.5|STANDARD_DEVIATION|20.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91622367|NCT01546285|183137585|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-4.73|-2.67||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.67|-4.73|
91622368|NCT00225147|183137586|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
91622369|NCT00225147|183137586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
91713503|NCT03143257|183318406|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|5.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91713504|NCT03143257|183318409|SUPERIORITY||Overall Benefit Score|-15.0|STANDARD_DEVIATION|18.5|||TWO_SIDED||||||||The overall benefit can be determined by subtracting the aided and unaided scores of Ease of Communication, Reverberation, Background Noise \& Aversiveness. A negative score in overall benefit indicates a positive benefit to the subject.|||||
91713505|NCT04547140|183318423|SUPERIORITY||Difference in percentages|3.3|||||TWO_SIDED|||||||||Percentage of Participants Dying||||
91713506|NCT04547140|183318423|SUPERIORITY||Difference in percentages|6.4|||||TWO_SIDED|||||||||Percentage of Participants Requiring ICU Admission||||
91713507|NCT04547140|183318424|SUPERIORITY||Difference in percentages|6.9|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on High Flow Oxygen Devices||||
91713508|NCT04547140|183318424|SUPERIORITY||Difference in percentages|3.4|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation||||
91713509|NCT04547140|183318425|SUPERIORITY||Least Squares (LS) Mean Difference|1.22||||0.1453|TWO_SIDED|95.0|-0.43|2.87||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||2.87|-0.43|0.1453
91713510|NCT04547140|183318425|SUPERIORITY||LS Mean Difference|0.21||||0.8015|TWO_SIDED|95.0|-1.44|1.86||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||1.86|-1.44|0.8015
91713511|NCT04547140|183318427|SUPERIORITY||LS Mean Difference of Duration|1.48||||0.5135|TWO_SIDED|95.0|-3.04|6.0||P-value was calculated using an analysis of variance (ANOVA) model, including the length of hospital stay (days) as a dependent variable and treatment group as a fixed effect.|ANOVA|||||6.00|-3.04|0.5135
91713512|NCT04547140|183318428|SUPERIORITY||LS Mean Difference of Duration|3.41||||0.1221|TWO_SIDED|95.0|-0.94|7.76||P-value was calculated using an ANOVA model, including the number of days in the ICU as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.76|-0.94|0.1221
91713513|NCT04547140|183318429|SUPERIORITY||LS Mean Difference of Duration|2.78||||0.3329|TWO_SIDED|95.0|-2.92|8.48||P-value was calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||8.48|-2.92|0.3329
91713514|NCT04547140|183318430|SUPERIORITY||LS Mean Difference of Duration|3.48||||0.1092|TWO_SIDED|95.0|-0.81|7.77||P-value was calculated using an ANOVA model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.77|-0.81|0.1092
91660687|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.47|||<|0.001|TWO_SIDED|95.0|10.68|16.27||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.27|10.68|<0.001
91660688|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.24|||<|0.001|TWO_SIDED|95.0|10.48|16.01||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.01|10.48|<0.001
91660689|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001|TWO_SIDED|95.0|7.33|12.83||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||12.83|7.33|<0.001
91713515|NCT04547140|183318431|SUPERIORITY||LS Mean Difference|-0.63||||0.1189|TWO_SIDED|95.0|-1.43|0.17||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||0.17|-1.43|0.1189
91713516|NCT04547140|183318431|SUPERIORITY||LS Mean Difference|-0.85||||0.0341|TWO_SIDED|95.0|-1.64|-0.07||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||-0.07|-1.64|0.0341
91622370|NCT00225147|183137587|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|||||||0.040
91622371|NCT00225147|183137587|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
91622372|NCT01114373|183137611|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0269
91622373|NCT01114373|183137611|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANOVA|||||||0.84
91622374|NCT01114373|183137612|SUPERIORITY_OR_OTHER|||||||0.0492|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0492
91622375|NCT01114373|183137612|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
91660690|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.21|||<|0.001|TWO_SIDED|95.0|14.71|23.71||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.71|14.71|<0.001
91660691|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.32|||<|0.001|TWO_SIDED|95.0|14.86|23.78||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.78|14.86|<0.001
91660692|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.87|||<|0.001|TWO_SIDED|95.0|9.44|18.3||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||18.30|9.44|<0.001
91660693|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.18|||<|0.001|TWO_SIDED|95.0|11.29|21.07||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||21.07|11.29|<0.001
91660694|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.65|||<|0.001|TWO_SIDED|95.0|12.81|22.49||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||22.49|12.81|<0.001
91660695|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.78|||<|0.001|TWO_SIDED|95.0|7.97|17.59||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||17.59|7.97|<0.001
91713517|NCT04547140|183318435|SUPERIORITY||Difference in percentages|1.9||||0.8809|TWO_SIDED|95.0|-24.1|28.3||P-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentages of participants experiencing sustained normalization of fever.|Chi-squared|||||28.3|-24.1|0.8809
91713518|NCT00048035|183318442|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.38|||||TWO_SIDED|90.0|0.32|0.42|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb.|All cohorts with dosing frequency 1 X / Week||0.42|0.32|
91622376|NCT01114373|183137613|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
91622377|NCT01114373|183137614|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||ANOVA|||||||0.88
91622378|NCT01114373|183137615|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||ANOVA|||||||0.16
91622379|NCT01114373|183137616|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
91622380|NCT01114373|183137617|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
91622381|NCT01114373|183137618|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
91622382|NCT01114373|183137619|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Friedman|||||||0.06
91622383|NCT01114373|183137620|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Friedman|||||||0.21
91622384|NCT01114373|183137621|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Friedman|||||||0.41
91622385|NCT01114373|183137622|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
91622386|NCT01114373|183137623|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
91622387|NCT01114373|183137624|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANOVA|||||||0.39
91660696|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.08|||<|0.001|TWO_SIDED|95.0|31.48|50.69||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||50.69|31.48|<0.001
91622388|NCT03444870|183137625|SUPERIORITY||Difference in adjusted mean|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0954|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.05|-0.66|0.0954
91622389|NCT03444870|183137627|SUPERIORITY||Difference in adjusted mean|-1.25|STANDARD_ERROR_OF_MEAN|0.65||0.0544|TWO_SIDED|95.0|-2.52|0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.02|-2.52|0.0544
91622390|NCT03444870|183137628|SUPERIORITY||Difference in adjusted mean|1.11|STANDARD_ERROR_OF_MEAN|0.81||0.1729|TWO_SIDED|95.0|-0.48|2.7|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4.||2.70|-0.48|0.1729
91660697|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.66|||<|0.001|TWO_SIDED|95.0|33.15|52.17||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||52.17|33.15|<0.001
91622391|NCT03444870|183137629|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.42||0.0425|TWO_SIDED|95.0|-1.68|-0.03|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.03|-1.68|0.0425
91660698|NCT00913627|183216457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|||<|0.001|TWO_SIDED|95.0|21.63|40.53||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||40.53|21.63|<0.001
91660699|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.13|||<|0.001|TWO_SIDED|95.0|6.45|9.8||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.80|6.45|<0.001
91791880|NCT00329901|183461314|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0||||||Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||-2|-13|
91660700|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|||<|0.001|TWO_SIDED|95.0|6.34|9.65||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.65|6.34|<0.001
91660701|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11|||<|0.001|TWO_SIDED|95.0|4.46|7.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||7.75|4.46|<0.001
91660702|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001|TWO_SIDED|95.0|9.02|14.34||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.34|9.02|<0.001
91660703|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.64|||<|0.001|TWO_SIDED|95.0|9.01|14.27||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.27|9.01|<0.001
91660704|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.001|TWO_SIDED|95.0|5.76|11.0||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||11.00|5.76|<0.001
91660705|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84|||<|0.001|TWO_SIDED|95.0|6.93|12.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||12.75|6.93|<0.001
91660706|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.59|||<|0.001|TWO_SIDED|95.0|7.71|13.46||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||13.46|7.71|<0.001
91660707|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.73|||<|0.001|TWO_SIDED|95.0|4.87|10.59||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||10.59|4.87|<0.001
91622392|NCT03444870|183137630|SUPERIORITY||Difference in adjusted mean|0.32|STANDARD_ERROR_OF_MEAN|0.31||0.2904|TWO_SIDED|95.0|-0.28|0.93|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||0.93|-0.28|0.2904
91622393|NCT03444870|183137631|SUPERIORITY||Difference in adjusted mean|-0.97|STANDARD_ERROR_OF_MEAN|0.6||0.1036|TWO_SIDED|95.0|-2.14|0.2|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.20|-2.14|0.1036
91622394|NCT03444870|183137632|SUPERIORITY||Difference in adjusted mean|-0.07|STANDARD_ERROR_OF_MEAN|0.37||0.8468|TWO_SIDED|95.0|-0.79|0.65|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.65|-0.79|0.8468
91622395|NCT03444870|183137633|SUPERIORITY||Difference in adjusted mean|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.803|TWO_SIDED|95.0|-1.35|1.74|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||1.74|-1.35|0.8030
91622396|NCT03444870|183137634|SUPERIORITY||Difference in adjusted mean|1.0|STANDARD_ERROR_OF_MEAN|0.68||0.1439|TWO_SIDED|95.0|-0.34|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.34|-0.34|0.1439
91622397|NCT03444870|183137641|SUPERIORITY||Difference in adjusted means|-66.44|STANDARD_ERROR_OF_MEAN|4.171|<|0.0001|TWO_SIDED|95.0|-74.71|-58.16|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-58.16|-74.71|<.0001
91622398|NCT03444870|183137642|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
91660708|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.93|||<|0.001|TWO_SIDED|95.0|19.24|30.61||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||30.61|19.24|<0.001
91660709|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.66|||<|0.001|TWO_SIDED|95.0|20.03|31.28||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||31.28|20.03|<0.001
91660710|NCT00913627|183216458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.78|||<|0.001|TWO_SIDED|95.0|13.19|24.38||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||24.38|13.19|<0.001
91622399|NCT03444870|183137642|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
91622400|NCT03444870|183137642|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
91660711|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.31||||0.08|TWO_SIDED|95.0|1.26|25.36||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||25.36|1.26|0.080
91660712|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.39||||0.043|TWO_SIDED|95.0|3.73|29.04||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||29.04|3.73|0.043
91660713|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.39||||0.354|TWO_SIDED|95.0|-4.62|15.4||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||15.40|-4.62|0.354
91660714|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.65|||<|0.001|TWO_SIDED|95.0|33.34|63.96||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||63.96|33.34|<0.001
91660715|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.94|||<|0.001|TWO_SIDED|95.0|37.15|66.73||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||66.73|37.15|<0.001
91660716|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.8|||<|0.001|TWO_SIDED|95.0|22.62|50.98||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||50.98|22.62|<0.001
91660717|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.39|||<|0.001|TWO_SIDED|95.0|41.2|73.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||73.57|41.20|<0.001
91622401|NCT03444870|183137642|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
91660718|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|66.67|||<|0.001|TWO_SIDED|95.0|51.56|81.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||81.78|51.56|<0.001
91660719|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.2|||<|0.001|TWO_SIDED|95.0|34.2|66.21||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||66.21|34.20|<0.001
91660720|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|67.64|||<|0.001|TWO_SIDED|95.0|51.36|83.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||83.93|51.36|<0.001
91660721|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|70.61|||<|0.001|TWO_SIDED|95.0|55.16|86.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||86.05|55.16|<0.001
91660722|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.85|||<|0.001|TWO_SIDED|95.0|34.32|69.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||69.38|34.32|<0.001
91660723|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||85.33|53.33|<0.001
91660724|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|74.21|||<|0.001|TWO_SIDED|95.0|59.29|89.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||89.14|59.29|<0.001
91660725|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.84|41.88|<0.001
91660726|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||85.33|53.33|<0.001
91660727|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||92.06|63.57|<0.001
91660728|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||75.84|41.88|<0.001
91660729|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||85.33|53.33|<0.001
91622402|NCT03444870|183137643|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||||<.001
91622403|NCT03444870|183137644|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
91622404|NCT03444870|183137645|SUPERIORITY|||||||0.396|||||||ANCOVA|||||||0.396
91622405|NCT03444870|183137646|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
91622406|NCT02034552|183137663|SUPERIORITY|||||||0.0109||||||\[80% CI\]: \[10.1%- 39.6%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||0.0109
91622407|NCT02034552|183137663|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[40.8% - 73.7%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
91622408|NCT02034552|183137663|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[31.8% - 68.2%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
91622409|NCT00074802|183137671|SUPERIORITY||Mean Difference (Net)|-5.43||||0.267|TWO_SIDED|95.0|-15.05|4.19|||Mixed Models Analysis|||||4.19|-15.05|.267
91622410|NCT00074802|183137672|SUPERIORITY|||||||0.018||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of responder status.||||.018
91622411|NCT00074802|183137672|SUPERIORITY|||||||0.034||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of remitter status.||||.034
91622412|NCT00074802|183137673|SUPERIORITY||Mean Difference (Net)|-3.21||||0.0005|TWO_SIDED|95.0|-5.02|-1.39|||Mixed Models Analysis|||||-1.39|-5.02|.0005
91622413|NCT00074802|183137674|SUPERIORITY||Mean Difference (Net)|-5.61||||0.0775|TWO_SIDED|95.0|-11.84|0.62|||Mixed Models Analysis|||||0.62|-11.84|.0775
91622414|NCT00074802|183137675|SUPERIORITY||Mean Difference (Net)|-5.53||||0.0006|TWO_SIDED|95.0|-8.7|-2.35|||Mixed Models Analysis||Paroxetine+CBT \> Paroxetine alone in BFNE change.|||-2.35|-8.70|.0006
91622415|NCT00074802|183137676|SUPERIORITY||Mean Difference (Net)|0.2||||0.871|TWO_SIDED|95.0|-2.16|2.55|||Mixed Models Analysis|||||2.55|-2.16|.871
91622416|NCT00074802|183137677|SUPERIORITY||Median Difference (Net)|0.41||||0.949|TWO_SIDED|95.0|-11.95|12.76|||Mixed Models Analysis|||||12.76|-11.95|.949
91525072|NCT01986101|182925453|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.03||0.057|TWO_SIDED|95.0|-4.0|0.1||Hochberg-adjusted.|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.1|-4.0|0.057
91622417|NCT02513771|183137708|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank-sum test stratified by screening CD4 count (\<= or \> 350 cells/mm\^3) and statin use.||Null hypothesis: There is no difference between the two arms in the change in sCD14 from baseline to week 15/16.||||1.000
91622418|NCT04295356|183137732|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of Cmax was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|102.6|||||TWO_SIDED|90.0|94.08|111.9|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS||111.90|94.08|
91622419|NCT04295356|183137733|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-inf was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|103.64|||||TWO_SIDED|90.0|93.98|114.29|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS||114.29|93.98|
91622420|NCT04295356|183137734|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-last was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|105.36|||||TWO_SIDED|90.0|91.09|121.86|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS||121.86|91.09|
91713519|NCT00048035|183318442|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.61|||||TWO_SIDED|90.0|0.53|0.76|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change.|All cohorts with dosing frequency 1 X /2 Week||0.76|0.53|
91791881|NCT00481507|183461428|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82|||>|0.05|TWO_SIDED|95.0|0.54|1.43||Reply: Only one test was performed for the primary outcome. No covariates were entered into this model and p-value is unadjusted.|Chi-squared|The results obtained from the logistic regression are equivalent to the chi-square test with one degree of freedom.||Reply: The null hypothesis was the rates of diarrhea for Kefir vs. Placebo are not different. Post power calculation was not performed because the difference observed (21.9% vs. 18%) was less than a difference that which would be considered clinically important.||1.43|0.54|>.05
91622421|NCT01784588|183137751|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Adjusted Difference in Percentages|-0.4|||||TWO_SIDED|90.0|-8.2|7.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||7.4|-8.2|
91622422|NCT01784588|183137751|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Unadjusted Treatment Difference (%)|1.5|||||TWO_SIDED|90.0|-5.4|8.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||8.4|-5.4|
91622423|NCT03807245|183137756|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 25mcg/placebo||||<0.0001
91622424|NCT03807245|183137756|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 50mcg/placebo||||<0.0001
91622425|NCT04904614|183137759|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
91622426|NCT04904614|183137760|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
91622427|NCT04904614|183137761|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
91622428|NCT04904614|183137763|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
91622429|NCT04268004|183137765|OTHER|Chi-squared test was used to determine if study arm is associated with FP uptake.|||||=|0.64|||||||Chi-squared|df=(1, 19)||Chi-square test was used to determine if study arm is associated with FP uptake.||||=.64
91622430|NCT01668030|183137773|SUPERIORITY|||||||0.0853|||||||t-test, 2 sided|||||||.0853
91622431|NCT04724733|183137783|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
91622432|NCT04724733|183137783|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
91622433|NCT04724733|183137783|SUPERIORITY|||||||0.0172|||||||t-test, 1 sided|||||||0.0172
91622434|NCT04724733|183137784|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||.0320
91622435|NCT04724733|183137784|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
91622436|NCT04724733|183137784|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
91622437|NCT03372603|183137801|OTHER||Ratio|1.336|||||TWO_SIDED|90.0|0.965|1.847|||||Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.|||1.847|0.965|
91622438|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.567|TWO_SIDED|95.0|-0.052|0.14|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.140|-0.052|0.567
91622439|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|0.113||||0.015|TWO_SIDED|95.0|0.018|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.209|0.018|0.015
91622440|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.059|TWO_SIDED|95.0|-0.003|0.188|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.188|-0.003|0.059
91622441|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.09|TWO_SIDED|95.0|-0.011|0.15|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.011|0.090
91622442|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.231|TWO_SIDED|95.0|-0.031|0.129|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.129|-0.031|0.231
91713520|NCT02619617|183318465|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|1.308||||0.698|TWO_SIDED|90.0|0.419|4.082|||Regression, Logistic|||||4.082|0.419|0.698
91713521|NCT02619617|183318466|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|2.033||||0.385|TWO_SIDED|90.0|0.53|7.79|||Regression, Logistic|||||7.790|0.530|0.385
91622443|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.612|TWO_SIDED|95.0|-0.101|0.059|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.059|-0.101|0.612
91622444|NCT03084718|183137820|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.011|TWO_SIDED|95.0|0.023|0.18|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.180|0.023|0.011
91622445|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.647|TWO_SIDED|95.0|-0.06|0.097|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.097|-0.060|0.647
91713522|NCT03064113|183318534|SUPERIORITY||Difference of LS Mean|173.8|||<|0.001|TWO_SIDED|95.0|112.4|235.3|||t-test, 2 sided|||||235.3|112.4|<0.001
91713523|NCT03064113|183318534|SUPERIORITY||Difference of LS Mean|169.3|||<|0.001|TWO_SIDED|95.0|107.8|230.8|||t-test, 2 sided|||||230.8|107.8|<0.001
91713524|NCT03064113|183318534|SUPERIORITY||Difference of LS Mean|175.6|||<|0.001|TWO_SIDED|95.0|114.1|237.2|||t-test, 2 sided|||||237.2|114.1|<0.001
91713525|NCT03064113|183318535|SUPERIORITY||Slope|112.5||||0.001|TWO_SIDED|95.0|44.5|180.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||180.5|44.5|0.001
91622446|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.004|TWO_SIDED|95.0|0.039|0.196|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.196|0.039|0.004
91660730|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||92.06|63.57|<0.001
91660731|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||75.84|41.88|<0.001
91791882|NCT04711837|183461447|NON_INFERIORITY|Non-inferiority margin equals to -8%|Risk Difference (RD)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0246|||TWO_SIDED|95.0|-0.054|0.042||Non-inferiority margin equals to -8%: 95% CI; (-5.4%, 4.2%)|Farrington-Manning method|||||0.042|-0.054|
91791883|NCT00814801|183461521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.0113|TWO_SIDED|95.0|-2.64|-0.34|||Least Square Means|||||-0.34|-2.64|0.0113
91622447|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.076|TWO_SIDED|95.0|-0.008|0.149|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.149|-0.008|0.076
91791884|NCT00814801|183461521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59|||<|0.0001|TWO_SIDED|95.0|-3.74|-1.44|||Least Square Means|||||-1.44|-3.74|<0.0001
91622448|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|0.099||||0.014|TWO_SIDED|95.0|0.02|0.179|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.179|0.020|0.014
91622449|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.192|TWO_SIDED|95.0|-0.026|0.131|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.131|-0.026|0.192
91660732|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||85.33|53.33|<0.001
91660733|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||92.06|63.57|<0.001
91713526|NCT03064113|183318535|SUPERIORITY||Difference of LS Mean|123.4|||<|0.001|TWO_SIDED|95.0|54.6|192.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||192.3|54.6|<0.001
91713527|NCT03064113|183318535|SUPERIORITY||Difference of LS Mean|15.3||||0.659|TWO_SIDED|95.0|-53.5|94.1|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||94.1|-53.5|0.659
91713528|NCT03064113|183318535|SUPERIORITY||Difference of LS Mean|102.8|||<|0.001|TWO_SIDED|95.0|54.1|151.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||151.5|54.1|<0.001
91713529|NCT03064113|183318535|SUPERIORITY||Difference of LS Mean|136.6|||<|0.001|TWO_SIDED|95.0|87.8|185.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||185.3|87.8|<0.001
91713530|NCT03064113|183318535|SUPERIORITY|Tx Difference of LS Mean FEV1 at 24 hr|Difference of LS Mean|-24.2||||0.327|TWO_SIDED|95.0|-72.9|24.6|||t-test, 2 sided|||||24.6|-72.9|0.327
91713531|NCT03064113|183318536|SUPERIORITY||Difference of LS Mean|26.4|||<|0.001|TWO_SIDED|95.0|18.0|34.8|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||34.8|18.0|<0.001
91713532|NCT03064113|183318536|SUPERIORITY||Difference of LS Mean|29.1|||<|0.001|TWO_SIDED|95.0|20.8|37.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||37.4|20.8|<0.001
91713533|NCT03064113|183318536|SUPERIORITY||Difference of LS Mean|25.6|||<|0.001|TWO_SIDED|95.0|17.3|33.9|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||33.9|17.3|<0.001
91713534|NCT03064113|183318536|SUPERIORITY||Difference of LS Mean|20.1|||<|0.001|TWO_SIDED|95.0|12.1|28.2|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||28.2|12.1|<0.001
91713535|NCT03064113|183318536|SUPERIORITY||Difference of LS Mean|25.4|||<|0.001|TWO_SIDED|95.0|17.4|33.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||33.4|17.4|<0.001
91791885|NCT00814801|183461523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0774|TWO_SIDED|95.0|-0.2|3.7|||Least Square Means|||||3.7|-0.2|0.0774
91791886|NCT00814801|183461523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.6207|TWO_SIDED|95.0|-1.5|2.4|||Least Square Means|||||2.4|-1.5|0.6207
91622450|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.244|TWO_SIDED|95.0|-0.126|0.032|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.032|-0.126|0.244
91622451|NCT03084718|183137821|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.06|TWO_SIDED|95.0|-0.003|0.151|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.151|-0.003|0.060
91622452|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.012||||0.78|TWO_SIDED|95.0|-0.074|0.098|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.098|-0.074|0.780
91622453|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.086|TWO_SIDED|95.0|-0.011|0.162|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.162|-0.011|0.086
91622454|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.324|TWO_SIDED|95.0|-0.043|0.129|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.129|-0.043|0.324
91622455|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.153|TWO_SIDED|95.0|-0.024|0.15|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.024|0.153
91622456|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.482|TWO_SIDED|95.0|-0.055|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.117|-0.055|0.482
91622457|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.463|TWO_SIDED|95.0|-0.119|0.054|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.054|-0.119|0.463
91622458|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.453|TWO_SIDED|95.0|-0.052|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.117|-0.052|0.453
91622459|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.533|TWO_SIDED|95.0|-0.064|0.123|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.123|-0.064|0.533
91622460|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.029|TWO_SIDED|95.0|0.011|0.199|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.199|0.011|0.029
91622461|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.274|TWO_SIDED|95.0|-0.041|0.146|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.146|-0.041|0.274
91622462|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.119|TWO_SIDED|95.0|-0.019|0.169|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.169|-0.019|0.119
91660734|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||75.84|41.88|<0.001
91791887|NCT00814801|183461524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8419|TWO_SIDED|95.0|-0.6|0.8|||Least Square Means|||||0.8|-0.6|0.8419
91622463|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.638|TWO_SIDED|95.0|-0.071|0.116|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.116|-0.071|0.638
91622464|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.274|TWO_SIDED|95.0|-0.147|0.042|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.042|-0.147|0.274
91622465|NCT03084718|183137822|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.092|TWO_SIDED|95.0|-0.013|0.171|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.171|-0.013|0.092
91622466|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.00|-0.31|0.053
91622467|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.001|TWO_SIDED|95.0|-0.42|-0.11|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.11|-0.42|0.001
91622468|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.006|TWO_SIDED|95.0|-0.37|-0.06|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.06|-0.37|0.006
91622469|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.176|TWO_SIDED|95.0|-0.26|0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.26|0.176
91660735|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||85.33|53.33|<0.001
91660736|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||92.06|63.57|<0.001
91791888|NCT00814801|183461524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7942|TWO_SIDED|95.0|-0.8|0.6|||Least Square Means|||||0.6|-0.8|0.7942
91791889|NCT00814801|183461525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.3141|TWO_SIDED|95.0|-1.6|0.5|||Least Square Means|||||0.5|-1.6|0.3141
91791890|NCT00814801|183461525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.6089|TWO_SIDED|95.0|-1.3|0.8|||Least Square Means|||||0.8|-1.3|0.6089
91713536|NCT03064113|183318536|SUPERIORITY||Difference of LS Mean|10.6||||0.01|TWO_SIDED|95.0|2.5|18.6|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hr||18.6|2.5|0.010
91791891|NCT02081248|183461547|SUPERIORITY|||||||0.37||||||Testing was performed at a significance level of 0.05|t-test, 2 sided|Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom||The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.37
91622470|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.423|TWO_SIDED|95.0|-0.22|0.09|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.09|-0.22|0.423
91622471|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.574|TWO_SIDED|95.0|-0.11|0.2|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.20|-0.11|0.574
91622472|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.011|TWO_SIDED|95.0|-0.35|-0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.35|0.011
91622473|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.215|TWO_SIDED|95.0|-0.27|0.06|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo"||0.06|-0.27|0.215
91622474|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.07|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.01|-0.32|0.070
91622475|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.005|TWO_SIDED|95.0|-0.4|-0.07|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.07|-0.40|0.005
91622476|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.566|TWO_SIDED|95.0|-0.21|0.12|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.12|-0.21|0.566
91622477|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.04|-0.29|0.124
91622478|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.336|TWO_SIDED|95.0|-0.25|0.08|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.08|-0.25|0.336
91622479|NCT03084718|183137823|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.01|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.37|0.010
91622480|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.067|TWO_SIDED|95.0|-0.38|0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.01|-0.38|0.067
91622481|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.53|-0.14|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.53|< 0.001
91622482|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.038|TWO_SIDED|95.0|-0.4|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.40|0.038
91622483|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.13|TWO_SIDED|95.0|-0.35|0.05|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.35|0.130
91622484|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.811|TWO_SIDED|95.0|-0.22|0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.17|-0.22|0.811
91622485|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.202|TWO_SIDED|95.0|-0.07|0.33|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.33|-0.07|0.202
91622486|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.39|0.044
91713537|NCT03064113|183318537|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
91622487|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.283|TWO_SIDED|95.0|-0.37|0.11|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.11|-0.37|0.283
91713538|NCT03064113|183318537|SUPERIORITY||Difference of LS Mean|0.1||||0.046|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.046
91713539|NCT03064113|183318537|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
91660737|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.84|41.88|<0.001
91660738|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
91660739|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
91660740|NCT00913627|183216459|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
91660741|NCT00913627|183216460|SUPERIORITY_OR_OTHER||Hazard Ratio, log|13.56|||<|0.001|TWO_SIDED|95.0|4.85|37.89||p-value adjusted for gender and categorical baseline pain severity|Proportional hazards regression|||||37.89|4.85|<0.001
91660742|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|2.03||||0.434|TWO_SIDED|95.0|-1.95|6.02||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||6.02|-1.95|0.434
91713540|NCT03064113|183318537|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.003
91660743|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Cochran-Mantel-Haenszel|||15 minutes||0.00|0.00|
91660744|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.78||||0.469|TWO_SIDED|95.0|-1.71|5.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||5.27|-1.71|0.469
91660745|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.13||||0.101|TWO_SIDED|95.0|1.33|16.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||16.93|1.33|0.101
91660746|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.73||||0.069|TWO_SIDED|95.0|2.54|18.91||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||18.91|2.54|0.069
91660747|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.59||||0.303|TWO_SIDED|95.0|-1.39|8.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||8.57|-1.39|0.303
91660748|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|24.58||||0.008|TWO_SIDED|95.0|10.68|38.47||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||38.47|10.68|0.008
91660749|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|25.31||||0.007|TWO_SIDED|95.0|11.35|39.28||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||39.28|11.35|0.007
91660750|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.62||||0.129|TWO_SIDED|95.0|-0.68|21.92||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||21.92|-0.68|0.129
91660751|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|47.72|||<|0.001|TWO_SIDED|95.0|32.25|63.19||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||63.19|32.25|<0.001
91660752|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.01|||<|0.001|TWO_SIDED|95.0|21.24|50.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||50.78|21.24|<0.001
91660753|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|27.87||||0.003|TWO_SIDED|95.0|13.93|41.81||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||41.81|13.93|0.003
91660754|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|61.01|||<|0.001|TWO_SIDED|95.0|46.12|75.89||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.89|46.12|<0.001
91660755|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.83|||<|0.001|TWO_SIDED|95.0|38.85|68.8||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||68.80|38.85|<0.001
91660756|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|31.89|61.58||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||61.58|31.89|<0.001
91660757|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.78|||<|0.001|TWO_SIDED|95.0|49.37|80.18||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||80.18|49.37|<0.001
91660758|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.8|||<|0.001|TWO_SIDED|95.0|50.01|79.59||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||79.59|50.01|<0.001
91660759|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.19|||<|0.001|TWO_SIDED|95.0|34.27|66.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||66.11|34.27|<0.001
91660760|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|68.59|||<|0.001|TWO_SIDED|95.0|52.81|84.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||84.38|52.81|<0.001
91713541|NCT03064113|183318537|SUPERIORITY||Difference of LS Mean|0.1||||0.048|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.048
91713542|NCT03064113|183318537|SUPERIORITY||Difference of LS Mean|0.1||||0.007|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.007
91660761|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.16|||<|0.001|TWO_SIDED|95.0|57.05|87.26||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||87.26|57.05|<0.001
91622488|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.003|TWO_SIDED|95.0|-0.6|-0.13|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.13|-0.60|0.003
91622489|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.027|TWO_SIDED|95.0|-0.5|-0.03|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.50|0.027
91622490|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.054|TWO_SIDED|95.0|-0.48|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.00|-0.48|0.054
91622491|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.258|TWO_SIDED|95.0|-0.38|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.10|-0.38|0.258
91622492|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.423|TWO_SIDED|95.0|-0.14|0.34|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.34|-0.14|0.423
91622493|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.111|TWO_SIDED|95.0|-0.42|0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.04|-0.42|0.111
91622494|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.135|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.05|-0.36|0.135
91660762|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.47|||<|0.001|TWO_SIDED|95.0|36.57|70.37||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||70.37|36.57|<0.001
91660763|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||87.84|57.48|<0.001
91622495|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.56|< 0.001
91622496|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.024|TWO_SIDED|95.0|-0.44|-0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.44|0.024
91660764|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|79.36|||<|0.001|TWO_SIDED|95.0|65.68|93.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||93.05|65.68|<0.001
91622497|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.067|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.01|-0.40|0.067
91622498|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.444|TWO_SIDED|95.0|-0.29|0.13|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.13|-0.29|0.444
91622499|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.285|TWO_SIDED|95.0|-0.09|0.32|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.32|-0.09|0.285
91622500|NCT03084718|183137824|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.06|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.01|-0.40|0.060
91622501|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.115|TWO_SIDED|95.0|-1.1|10.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.0|-1.1|0.115
91660765|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.03|||<|0.001|TWO_SIDED|95.0|40.46|73.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||73.60|40.46|<0.001
91660766|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||87.84|57.48|<0.001
91622502|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.008|TWO_SIDED|95.0|2.0|13.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|2.0|0.008
91660767|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|81.2|||<|0.001|TWO_SIDED|95.0|67.91|94.49||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||94.49|67.91|<0.001
91660768|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.84|||<|0.001|TWO_SIDED|95.0|42.34|75.35||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.35|42.34|<0.001
91525073|NCT01986101|182925454|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.127||0.002|TWO_SIDED|95.0|-0.65|-0.15|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.15|-0.65|0.002
91622503|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.099|TWO_SIDED|95.0|-0.9|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-0.9|0.099
91622504|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.275|TWO_SIDED|95.0|-2.5|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.5|0.275
91622505|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.943|TWO_SIDED|95.0|-5.4|5.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.8|-5.4|0.943
91622506|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.308|TWO_SIDED|95.0|-8.6|2.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.7|-8.6|0.308
91622507|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.024|TWO_SIDED|95.0|0.8|11.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||11.7|0.8|0.024
91622508|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.129|TWO_SIDED|95.0|-1.4|11.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.0|-1.4|0.129
91622509|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.8|15.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||15.2|2.8|0.004
91622510|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.061|TWO_SIDED|95.0|-0.3|12.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.1|-0.3|0.061
91622511|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.18|TWO_SIDED|95.0|-2.0|10.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.5|-2.0|0.180
91622512|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.721|TWO_SIDED|95.0|-5.1|7.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.4|-5.1|0.721
91622513|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.328|TWO_SIDED|95.0|-9.4|3.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-9.4|0.328
91622514|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.022|TWO_SIDED|95.0|1.0|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.2|1.0|0.022
91622515|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.101|TWO_SIDED|95.0|-0.9|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-0.9|0.101
91660769|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
91622516|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.003|TWO_SIDED|95.0|2.8|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.9|2.8|0.003
91622517|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.061|TWO_SIDED|95.0|-0.2|10.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.8|-0.2|0.061
91622518|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.196|TWO_SIDED|95.0|-1.9|9.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.3|-1.9|0.196
91660770|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
91713543|NCT03064113|183318538|SUPERIORITY||Difference of LS Mean|0.1||||0.054|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.054
91660771|NCT00913627|183216461|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
91660772|NCT00913627|183216462|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
91622519|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.814|TWO_SIDED|95.0|-4.9|6.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.3|-4.9|0.814
91660773|NCT00913627|183216462|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.02||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.02|0.88|<0.001
91622520|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.291|TWO_SIDED|95.0|-8.6|2.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.6|-8.6|0.291
91489383|NCT02484690|182851569|SUPERIORITY||Difference in Least Squares Means|-7.32||||0.3932|TWO_SIDED|80.0|-18.32|3.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||3.67|-18.32|0.3932
91660774|NCT00913627|183216462|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.84|||<|0.001|TWO_SIDED|95.0|0.7|0.98||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.98|0.70|<0.001
91660775|NCT00913627|183216463|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
91660776|NCT00913627|183216463|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.96|||<|0.001|TWO_SIDED|95.0|0.91|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.91|<0.001
91660777|NCT00913627|183216463|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.89|||<|0.001|TWO_SIDED|95.0|0.79|0.99||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.99|0.79|<0.001
91660778|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.008
91660779|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.007|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.007
91660780|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.024|TWO_SIDED|95.0|0.02|0.34||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.34|0.02|0.024
91660781|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||<|0.001|TWO_SIDED|95.0|0.24|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.78|0.24|<0.001
91622521|NCT03084718|183137825|SUPERIORITY||Mean Difference (Final Values)|6.7||||0.016|TWO_SIDED|95.0|1.3|12.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.1|1.3|0.016
91660782|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|0.2|0.73||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.73|0.20|<0.001
91660783|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.002|TWO_SIDED|95.0|0.16|0.68||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.68|0.16|0.002
91660784|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.17||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.17|0.52|<0.001
91660785|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|||<|0.001|TWO_SIDED|95.0|0.47|1.11||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.11|0.47|<0.001
91660786|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.3|0.94||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||0.94|0.30|<0.001
91660787|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.65|1.37||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.37|0.65|<0.001
91791892|NCT02081248|183461548|SUPERIORITY|||||||0.39||||||Testing performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.39
91791893|NCT02081248|183461549|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.17
91791894|NCT02081248|183461552|SUPERIORITY|||||||0.21||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.21
91791895|NCT02081248|183461552|SUPERIORITY|||||||0.25||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.25
91791896|NCT02081248|183461553|SUPERIORITY|||||||0.8||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.||||0.80
91791897|NCT02081248|183461554|SUPERIORITY|||||||0.73||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.||||0.73
91791898|NCT02081248|183461554|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.||||0.26
91791899|NCT02081248|183461554|SUPERIORITY|||||||0.74||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.||||0.74
91791900|NCT02081248|183461554|SUPERIORITY|||||||0.56||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.||||0.56
91791901|NCT02081248|183461554|SUPERIORITY|||||||0.79||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.||||0.79
91791902|NCT02081248|183461555|SUPERIORITY|||||||1||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.||||1.00
91791903|NCT02081248|183461555|SUPERIORITY|||||||0.77||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.77
91791904|NCT02081248|183461555|SUPERIORITY|||||||0.69||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.69
91622522|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622523|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622524|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622525|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.913
91622526|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.871|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.871
91622527|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.958
91622528|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622529|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.01|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.010
91622530|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.011|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.011
91622531|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
91622532|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.996
91660788|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|||<|0.001|TWO_SIDED|95.0|0.73|1.44||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.44|0.73|<0.001
91622533|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.632|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.632
91713544|NCT03064113|183318538|SUPERIORITY||Difference of LS Mean|0.1||||0.045|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.045
91622534|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.63|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.630
91622535|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622536|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
91622537|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.001|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.001
91622538|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622539|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.96|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.960
91622540|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.725|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.725
91622541|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.764|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.764
91622542|NCT03084718|183137826|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
91622543|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.316|TWO_SIDED|95.0|-2.8|8.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.7|-2.8|0.316
91622544|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|4.9||||0.097|TWO_SIDED|95.0|-0.9|10.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.7|-0.9|0.097
91622545|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.128|TWO_SIDED|95.0|-1.3|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-1.3|0.128
91660789|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.54|1.25||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.25|0.54|<0.001
91660790|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.9|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.63|0.90|<0.001
91480892|NCT04193410|182834425|OTHER|Linear mixed model analyses assessed longitudinal intervention effects on children's BMI z-score. A two-level model with measurements as first level and participants as second was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at T0 (four/five/six), SES (low/middle/high), and children's weight status at T0 (underweight/normal weight/overweight). This analyses reports T1-T0.||||||0.21|||||||Mixed Models Analysis|||||||0.210
91660791|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|||<|0.001|TWO_SIDED|95.0|0.97|1.69||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.69|0.97|<0.001
91660792|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.74|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.45|0.74|<0.001
91660793|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED|95.0|1.09|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.09|<0.001
91660794|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.10|<0.001
91660795|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.67|1.38||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.38|0.67|<0.001
91622546|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.511|TWO_SIDED|95.0|-3.9|7.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.8|-3.9|0.511
91622547|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.61|TWO_SIDED|95.0|-4.3|7.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.3|-4.3|0.610
91660796|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.00|1.26|<0.001
91660797|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.98|1.25|<0.001
91660798|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.85|1.57||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.57|0.85|<0.001
91480893|NCT04193410|182834425|OTHER|||||||0.793|||||||Mixed Models Analysis|||Linear mixed model analyses assessed longitudinal intervention effects on children's BMI z-score. A two-level model with measurements as first level and participants as second was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at T0 (four/five/six), SES (low/middle/high), and children's weight status at T0 (underweight/normal weight/overweight). This analyses reports T2-T0.||||0.793
91480894|NCT04193410|182834426|OTHER|||||||0.444|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T1-T0.||||0.444
91480895|NCT04193410|182834426|OTHER|||||||0.863|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T2-T0.||||0.863
91480896|NCT04193410|182834427|OTHER|||||||0.053|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's PA score. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T1-T0.||||0.053
91480897|NCT04193410|182834427|OTHER|||||||0.209|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's PA score. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T2-T0.||||0.209
91480898|NCT04193410|182834428|OTHER|||||||0.003|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's waist circumference. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T1-T0.||||0.003
91480899|NCT04193410|182834428|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's waist circumference. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T2-T0.||||<0.001
91480900|NCT04193410|182834429|OTHER|||||||0.815|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T1-T0.||||0.815
91480901|NCT04193410|182834429|OTHER|||||||0.418|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T2-T0.||||0.418
91480902|NCT04193410|182834430|OTHER|||||||0.307|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T1-T0.||||0.307
91480903|NCT04193410|182834430|OTHER|||||||0.263|||||||Mixed Models Analysis|||Linear mixed model analyses were used to assess longitudinal intervention effects on children's dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. This analysis reports T2-T0.||||0.263
91480904|NCT04193410|182834431|OTHER|||||||0.249|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.249
91480905|NCT04193410|182834431|OTHER|||||||0.803|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T2-T0.||||0.803
91713545|NCT03064113|183318538|SUPERIORITY||Difference of LS Mean|0.0||||0.503|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.503
91480906|NCT04193410|182834432|OTHER|||||||0.073|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.073
91480907|NCT04193410|182834432|OTHER|||||||0.658|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T2-T0.||||0.658
91480908|NCT04193410|182834433|OTHER|||||||0.742|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.742
91480909|NCT04193410|182834433|OTHER|||||||0.37|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T2-T0.||||0.370
91480910|NCT04193410|182834434|OTHER|||||||0.483|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.483
91480911|NCT04193410|182834434|OTHER|||||||0.626|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T2-T0.||||0.626
91480912|NCT04193410|182834435|OTHER|||||||0.771|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.771
91480913|NCT04193410|182834435|OTHER|||||||0.861|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.861
91480914|NCT04193410|182834436|OTHER|||||||0.766|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.766
91622548|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.882|TWO_SIDED|95.0|-6.3|5.4|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.4|-6.3|0.882
91622549|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|7.2||||0.013|TWO_SIDED|95.0|1.5|12.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.9|1.5|0.013
91480915|NCT04193410|182834436|OTHER|||||||0.995|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T2-T0.||||0.995
91480916|NCT04193410|182834437|OTHER|||||||0.437|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.437
91622550|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.219|TWO_SIDED|95.0|-2.8|12.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||12.2|-2.8|0.219
91713546|NCT03064113|183318538|SUPERIORITY||Difference of LS Mean|0.0||||0.183|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.183
91622551|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.166|TWO_SIDED|95.0|-2.2|12.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||12.8|-2.2|0.166
91622552|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.151|TWO_SIDED|95.0|-2.0|12.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.9|-2.0|0.151
91622553|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.871|TWO_SIDED|95.0|-6.9|8.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.2|-6.9|0.871
91622554|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.837|TWO_SIDED|95.0|-6.8|8.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.3|-6.8|0.837
91622555|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.966|TWO_SIDED|95.0|-7.4|7.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||7.7|-7.4|0.966
91622556|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|9.5||||0.012|TWO_SIDED|95.0|2.1|16.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||16.9|2.1|0.012
91622557|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.233|TWO_SIDED|95.0|-2.5|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-2.5|0.233
91622558|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|5.1||||0.113|TWO_SIDED|95.0|-1.2|11.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.4|-1.2|0.113
91622559|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.12|TWO_SIDED|95.0|-1.3|11.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.2|-1.3|0.120
91622560|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.691|TWO_SIDED|95.0|-5.1|7.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.6|-5.1|0.691
91622561|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.722|TWO_SIDED|95.0|-5.2|7.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.5|-5.2|0.722
91622562|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|95.0|-6.5|6.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.2|-6.5|0.966
91622563|NCT03084718|183137827|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.008|TWO_SIDED|95.0|2.2|14.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||14.5|2.2|0.008
91622564|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.426|TWO_SIDED|95.0|-3.4|7.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||7.9|-3.4|0.426
91622565|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.055|TWO_SIDED|95.0|-0.1|11.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.2|-0.1|0.055
91622566|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.059|TWO_SIDED|95.0|-0.2|11.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.1|-0.2|0.059
91660799|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.08|1.33|<0.001
91660800|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.97|1.23|<0.001
91660801|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED|95.0|0.81|1.54||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.54|0.81|<0.001
91660802|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.00|1.20|<0.001
91660803|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|1.19|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.98|1.19|<0.001
91660804|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.73|1.52||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.52|0.73|<0.001
91660805|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|||<|0.001|TWO_SIDED|95.0|1.08|1.9||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.90|1.08|<0.001
91660806|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.97|1.16|<0.001
91660807|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.53|0.72|<0.001
91660808|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.97|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.79|0.97|<0.001
91660809|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55|||<|0.001|TWO_SIDED|95.0|1.14|1.95||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.95|1.14|<0.001
91660810|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED|95.0|0.62|1.43||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.43|0.62|<0.001
91480917|NCT04193410|182834437|OTHER|||||||0.798|||||||Mixed Models Analysis|||Logistic mixed model analyses were used to assess longitudinal intervention effects on children's binary dietary behaviours. A two-level model with measurements as first level and participants as second level was used. The model's fixed part consisted of group (medium/low implementers), time (T0/T1/T2), interaction term of group with time, and covariates sex (boy/girl), study year at baseline (four/five/six), SES (low/middle/high), and children's BMI z-score at baseline. Analysis reports T1-T0.||||0.798
91622567|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.263|TWO_SIDED|95.0|-2.5|9.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.0|-2.5|0.263
91622568|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.28|TWO_SIDED|95.0|-2.6|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.6|0.280
91622569|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.965|TWO_SIDED|95.0|-5.9|5.6|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.6|-5.9|0.965
91622570|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.007|TWO_SIDED|95.0|2.2|13.3|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.3|2.2|0.007
91622571|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.308|TWO_SIDED|95.0|-3.5|11.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.2|-3.5|0.308
91622572|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|5.8||||0.124|TWO_SIDED|95.0|-1.6|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.2|-1.6|0.124
91713547|NCT03064113|183318538|SUPERIORITY||Difference of LS Mean|0.0||||0.422|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.422
91713548|NCT03064113|183318538|SUPERIORITY||Difference of LS Mean|0.0||||0.287|TWO_SIDED|95.0|-0.1|0.0|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.0|-0.1|0.287
91622573|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.063|TWO_SIDED|95.0|-0.4|14.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||14.3|-0.4|0.063
91713549|NCT03064113|183318540|SUPERIORITY||Difference of LS Mean|3975.5|||<|0.001|TWO_SIDED|95.0|2007.3|5943.7|||t-test, 2 sided|||||5943.7|2007.3|<0.001
91713550|NCT03064113|183318540|SUPERIORITY||Difference of LS Mean|5888.9|||<|0.001|TWO_SIDED|95.0|3924.4|7853.4|||t-test, 2 sided|||||7853.4|3924.4|<0.001
91622574|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.602|TWO_SIDED|95.0|-5.5|9.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-5.5|0.602
91713551|NCT03064113|183318540|SUPERIORITY||Difference of LS Mean|2654.7||||0.009|TWO_SIDED|95.0|689.7|4619.6|||t-test, 2 sided|||||4619.6|689.7|0.009
91713552|NCT02389959|183318610|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.11||||0.111|TWO_SIDED|95.0|-2.47|0.26|||Regression, Linear|||Analysis between groups at month 1.||0.26|-2.47|0.111
91713553|NCT02389959|183318610|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.26||||0.131|TWO_SIDED|95.0|-2.9|0.38|||Regression, Linear|||Analysis between groups at month 2.||0.38|-2.9|0.131
91713554|NCT02389959|183318610|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.85||||0.332|TWO_SIDED|95.0|-2.57|0.88|||Regression, Linear|||Analysis between groups at month 4.||0.88|-2.57|0.332
91713555|NCT02389959|183318610|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.48||||0.597|TWO_SIDED|95.0|-2.25|1.3|||Regression, Linear|||Analysis between groups at month 6.||1.3|-2.25|0.597
91713556|NCT02389959|183318611|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|2.85||||0.191|TWO_SIDED|95.0|-1.44|7.13|||Regression, Linear|||Analysis between groups at month 1.||7.13|-1.44|0.191
91622575|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.402|TWO_SIDED|95.0|-4.3|10.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.6|-4.3|0.402
91622576|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.753|TWO_SIDED|95.0|-6.3|8.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||8.6|-6.3|0.753
91622577|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.006|TWO_SIDED|95.0|2.9|17.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||17.4|2.9|0.006
91622578|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.331|TWO_SIDED|95.0|-3.1|9.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.2|-3.1|0.331
91713557|NCT02389959|183318611|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.29||||0.914|TWO_SIDED|95.0|-5.02|5.61|||Regression, Linear|||Analysis between groups at month 2||5.61|-5.02|0.914
91713558|NCT02389959|183318611|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|1.55||||0.592|TWO_SIDED|95.0|-4.17|7.28|||Regression, Linear|||Analysis between groups at month 4.||7.28|-4.17|0.592
91622579|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.073|TWO_SIDED|95.0|-0.5|11.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.9|-0.5|0.073
91622580|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.048|TWO_SIDED|95.0|0.1|12.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.4|0.1|0.048
91660811|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001|TWO_SIDED|95.0|0.93|1.77||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.77|0.93|<0.001
91660812|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.81|0.97|<0.001
91660813|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.63|1.46||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.46|0.63|<0.001
91660814|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||<|0.001|TWO_SIDED|95.0|0.87|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.71|0.87|<0.001
91713559|NCT02389959|183318611|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|3.1||||0.31|TWO_SIDED|95.0|-2.92|9.12|||Regression, Linear|||Analysis between groups at month 6||9.12|-2.92|0.31
91713560|NCT02389959|183318612|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-2.63||||0.366|TWO_SIDED|95.0|-8.38|3.11|||Regression, Linear|||Analysis between groups at month 1.||3.11|-8.38|0.366
91622581|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.41|TWO_SIDED|95.0|-3.6|8.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.9|-3.6|0.410
91622582|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED|95.0|-3.1|9.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-3.1|0.320
91713561|NCT02389959|183318612|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.82||||0.816|TWO_SIDED|95.0|-6.12|7.76|||Regression, Linear|||Analysis between groups at month 2||7.76|-6.12|0.816
91480945|NCT05217927|182834573|SUPERIORITY||Least square mean (LSM) Difference|-0.6|||=|0.022|TWO_SIDED|97.5|-1.22|-0.01|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy), month and month-by-treatment group interaction as fixed effects.||-0.01|-1.22|=0.0220
91622583|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.867|TWO_SIDED|95.0|-5.7|6.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.8|-5.7|0.867
91660815|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.81|0.97|<0.001
91622584|NCT03084718|183137828|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.9|15.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.0|2.9|0.004
91660816|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED|95.0|0.56|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.39|0.56|<0.001
91660817|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.82|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.68|0.82|<0.001
91622585|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.26|TWO_SIDED|95.0|-3.2|11.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.9|-3.2|0.260
91622586|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.387|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.9|-4.2|0.387
91660818|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.03|1.89||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.89|1.03|<0.001
91660819|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.6|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.45|0.60|<0.001
91660820|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.64|0.77|<0.001
91660821|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|1.0|1.87||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.87|1.00|<0.001
91660822|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.48|0.61|<0.001
91713562|NCT02389959|183318612|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-4.3||||0.247|TWO_SIDED|95.0|-11.61|3.02|||Regression, Linear|||Analysis between groups at month 4.||3.02|-11.61|0.247
91660823|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.81|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.68|0.81|<0.001
91660824|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.96|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.82|0.96|<0.001
91660825|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.53|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.39|0.53|<0.001
91660826|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.75|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.64|0.75|<0.001
91660827|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.65||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.65|0.77|<0.001
91622587|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.574|TWO_SIDED|95.0|-5.4|9.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||9.7|-5.4|0.574
91622588|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.799|TWO_SIDED|95.0|-8.6|6.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.7|-8.6|0.799
91622589|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.577|TWO_SIDED|95.0|-9.8|5.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.5|-9.8|0.577
91622590|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.764|TWO_SIDED|95.0|-8.8|6.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.5|-8.8|0.764
91660828|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED|95.0|0.49|1.36||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.36|0.49|<0.001
91660829|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||<|0.001|TWO_SIDED|95.0|0.6|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.53|0.60|<0.001
91660830|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.58|0.66|<0.001
91660831|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.33|0.42|<0.001
91713563|NCT02389959|183318612|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-8.18||||0.035|TWO_SIDED|95.0|-15.76|-0.6|||Regression, Linear|||Analysis between groups at month 6||-0.6|-15.76|0.035
91713564|NCT02389959|183318613|OTHER|||||||0.03|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at baseline.||||0.030
91713565|NCT02389959|183318613|OTHER|||||||0.719|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 2.||||0.719
91713566|NCT02389959|183318613|OTHER|||||||0.467|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 6.||||0.467
91622591|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.097|TWO_SIDED|95.0|-1.1|13.8|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.8|-1.1|0.097
91660832|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.51|0.61|<0.001
91660833|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.58|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.48|0.58|<0.001
91660834|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.52|1.4||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.40|0.52|<0.001
91660835|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.001|TWO_SIDED|95.0|0.31|1.24||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.24|0.31|0.001
91713567|NCT01401543|183318634|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.91|
91622592|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.908|TWO_SIDED|95.0|-9.9|8.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.8|-9.9|0.908
91622593|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.135|TWO_SIDED|95.0|-2.2|16.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||16.5|-2.2|0.135
91622594|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.786|TWO_SIDED|95.0|-10.7|8.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo"||8.1|-10.7|0.786
91622595|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.109|TWO_SIDED|95.0|-1.7|17.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||17.1|-1.7|0.109
91622596|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-10.1|8.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.7|-10.1|0.876
91622597|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.08|TWO_SIDED|95.0|-17.9|1.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||1.0|-17.9|0.080
91660836|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.001|TWO_SIDED|95.0|0.36|1.28||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.28|0.36|<0.001
91660837|NCT00913627|183216464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.33|0.42|<0.001
91660838|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.034|TWO_SIDED|95.0|0.02|0.57||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.57|0.02|0.034
91713568|NCT01401543|183318634|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.93|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.93|0.85|
91480946|NCT05217927|182834573|SUPERIORITY||LSM Difference|-1.8|||<|0.0001|TWO_SIDED|97.5|-2.35|-1.19|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy), month and month-by-treatment group interaction as fixed effects.||-1.19|-2.35|<0.0001
91622598|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.202|TWO_SIDED|95.0|-3.2|15.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.3|-3.2|0.202
91622599|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.635|TWO_SIDED|95.0|-5.9|9.7|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.7|-5.9|0.635
91622600|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.191|TWO_SIDED|95.0|-2.6|13.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|-2.6|0.191
91622601|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.914|TWO_SIDED|95.0|-7.4|8.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||8.3|-7.4|0.914
91622602|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.407|TWO_SIDED|95.0|-4.6|11.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||11.3|-4.6|0.407
91622603|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.718|TWO_SIDED|95.0|-9.4|6.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.4|-9.4|0.718
91622604|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.235|TWO_SIDED|95.0|-12.7|3.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-12.7|0.235
91622605|NCT03084718|183137829|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.118|TWO_SIDED|95.0|-1.6|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.9|-1.6|0.118
91622606|NCT03341923|183137836|NON_INFERIORITY|"Difference (DT1MF-AMMF) of percentage of subjects rated as Optimal was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated."|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
91660839|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.111|TWO_SIDED|95.0|-0.05|0.49||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.49|-0.05|0.111
91660840|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.125|TWO_SIDED|95.0|-0.06|0.48||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.48|-0.06|0.125
91622607|NCT03341923|183137836|SUPERIORITY|After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
91660841|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.22|0.41|<0.001
91480947|NCT05217927|182834574|SUPERIORITY||Difference in percentage|7.4|||=|0.0966|TWO_SIDED|97.5|-2.6|17.4|||Mantel Haenszel|||Mantel-Haenszel risk estimation was used.||17.4|-2.6|=0.0966
91622608|NCT02806947|183137837|OTHER|No formal hypothesis test was planned or performed for comparing Day 28 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 90% confidence interval.|Risk Difference (RD)|-0.082|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.223|0.059|||||The risk difference estimate is the observed proportion of Day 28 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|The primary objective of this Phase II trial was to describe the proportion of patients with Day 28 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 90% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.059|-0.223|
91622609|NCT02806947|183137837|OTHER|No formal hypothesis test was planned or performed for comparing Day 56 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 95% confidence interval.|Risk Difference (RD)|-0.152|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|95.0|-0.315|0.011|||||The risk difference estimate is the observed proportion of Day 56 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|A secondary objective of this Phase II trial was to describe the proportion of patients with Day 56 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 95% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.011|-0.315|
91622610|NCT02806947|183137838|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with CR/PR and steroid dose of 0.25mg/kg/day or less at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||< 0.001
91660842|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.003|TWO_SIDED|95.0|0.22|1.01||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.01|0.22|0.003
91660843|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.004|TWO_SIDED|95.0|0.19|0.98||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.98|0.19|0.004
91660844|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41|||<|0.001|TWO_SIDED|95.0|0.91|1.91||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.91|0.91|<0.001
91622611|NCT02806947|183137839|SUPERIORITY|||||||0.32||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 28 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.320
91660845|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.001|TWO_SIDED|95.0|0.75|1.74||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.74|0.75|<0.001
91660846|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.41|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.39|0.41|<0.001
91622612|NCT02806947|183137839|SUPERIORITY|||||||0.014||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 56 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.014
91622613|NCT02806947|183137840|SUPERIORITY|||||||0.078||||||Statistical significance was determine using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.078
91660847|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.11|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.16|1.11|<0.001
91660848|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.05|2.09||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.09|1.05|<0.001
91660849|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.75|1.78||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.78|0.75|<0.001
91660850|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|||<|0.001|TWO_SIDED|95.0|1.46|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.52|1.46|<0.001
91660851|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.61||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.61|1.57|<0.001
91660852|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|1.16|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.20|1.16|<0.001
91660853|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.59|2.64||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.64|1.59|<0.001
91660854|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.7|2.74||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.74|1.70|<0.001
91660855|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||<|0.001|TWO_SIDED|95.0|1.18|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.21|1.18|<0.001
91660856|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.98|3.01||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.01|1.98|<0.001
91713569|NCT01401543|183318634|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.97|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.97|0.88|
91660857|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||<|0.001|TWO_SIDED|95.0|1.97|2.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.99|1.97|<0.001
91660858|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.38||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.38|1.37|<0.001
91660859|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54|||<|0.001|TWO_SIDED|95.0|2.01|3.07||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.07|2.01|<0.001
91660860|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.92|2.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.97|1.92|<0.001
91660861|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.33||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.33|1.29|<0.001
91660862|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|||<|0.001|TWO_SIDED|95.0|1.92|3.03||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.03|1.92|<0.001
91660863|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|||<|0.001|TWO_SIDED|95.0|1.87|2.96||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.96|1.87|<0.001
91660864|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.16|2.25||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.25|1.16|<0.001
91660865|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.83|1.69|<0.001
91660866|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001|TWO_SIDED|95.0|1.8|2.93||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.93|1.80|<0.001
91660867|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|||<|0.001|TWO_SIDED|95.0|1.11|2.23||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.23|1.11|<0.001
91660868|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.66|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.79|1.66|<0.001
91480948|NCT05217927|182834574|SUPERIORITY||Difference in percentage|24.7|||<|0.0001|TWO_SIDED|97.5|14.6|34.8|||Mantel Haenszel|||Mantel-Haenszel risk estimation was used.||34.8|14.6|<0.0001
91525074|NCT01986101|182925454|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.019|TWO_SIDED|95.0|-0.56|-0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group.|||-0.05|-0.56|0.019
91622614|NCT02806947|183137840|SUPERIORITY|||||||0.068||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 56 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.068
91622615|NCT02806947|183137841|SUPERIORITY|||||||0.785||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with overall survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.785
91622616|NCT02806947|183137842|SUPERIORITY|||||||0.34||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with disease-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.340
91622617|NCT02806947|183137843|SUPERIORITY|||||||0.713||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with event-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.713
91622618|NCT02806947|183137844|SUPERIORITY|||||||0.726||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with non-relapse mortality between the sirolimus and prednisone arms during the 12 month period post-randomization, with malignancy relapse treated as a competing risk for non-relapse mortality. These proportions were compared between treatment arms using Gray's test.||||0.726
91622619|NCT02806947|183137845|SUPERIORITY|||||||0.402||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with malignancy relapse between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for malignancy relapse. These proportions were compared between treatment arms using Gray's test.||||0.402
91622620|NCT02806947|183137846|SUPERIORITY|||||||0.296||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the sirolimus and prednisone arms during the 12 month period post-randomization, with death and malignancy relapse treated as competing risks for chronic GVHD. These proportions were compared between treatment arms using Gray's test.||||0.296
91622621|NCT02806947|183137847|SUPERIORITY|||||||0.936||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.936
91622622|NCT02806947|183137847|SUPERIORITY|||||||0.598||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.598
91622623|NCT02806947|183137848|SUPERIORITY|||||||0.221||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with serious infections between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for serious infection. These proportions were compared between treatment arms using Gray's test.||||0.221
91622624|NCT04511819|183137857|OTHER||Risk Difference (RD)|-0.087||||0.8762|TWO_SIDED|95.0|-0.347|0.174|||Regression, Logistic|||||0.174|-0.347|0.8762
91622625|NCT01978509|183137924|SUPERIORITY|||||||0.7|||||||ANOVA|||||||0.70
91480949|NCT05217927|182834575|SUPERIORITY||LS Mean Difference|-0.2|||=|0.5314|TWO_SIDED|97.5|-0.95|0.54|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.||0.54|-0.95|=0.5314
91525075|NCT01986101|182925455|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.037|TWO_SIDED|95.0|-3.6|-0.1|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.1|-3.6|0.037
91660869|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.74|2.85||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.85|1.74|<0.001
91660870|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.02|2.13||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.13|1.02|<0.001
91660871|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.78||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.78|1.59|<0.001
91660872|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.53|2.7||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.70|1.53|<0.001
91660873|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.04|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.21|1.04|<0.001
91660874|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|||<|0.001|TWO_SIDED|95.0|1.3|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.52|1.30|<0.001
91622626|NCT00844649|183137928|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.617|0.835||P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.835|0.617|<0.0001
91622627|NCT00844649|183137929|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.581|0.821||P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.821|0.581|<0.0001
91622628|NCT00844649|183137930|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|3.19|||<|0.0001|TWO_SIDED|95.0|2.178|4.662|||Chi-squared||Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone|PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.||4.662|2.178|<0.0001
91622629|NCT01594333|183137935|SUPERIORITY||Cox Proportional Hazard|1.01||||0.91|TWO_SIDED|95.0|0.82|1.25||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(diabetes or metabolic syndrome alone)|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.25|0.82|0.91
91622630|NCT01594333|183137936|SUPERIORITY||Cox Proportional Hazard|0.96||||0.67|TWO_SIDED|95.0|0.79|1.16||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.16|0.79|0.67
91622631|NCT01594333|183137937|SUPERIORITY||Cox Proportional Hazard|1.16||||0.32|TWO_SIDED|95.0|0.87|1.56||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.56|0.87|0.32
91622632|NCT01594333|183137938|SUPERIORITY||Cox Proportional Hazard|0.95||||0.57|TWO_SIDED|95.0|0.81|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.81|0.57
91622633|NCT01594333|183137939|SUPERIORITY||Cox Proportional Hazard|0.89||||0.54|TWO_SIDED|95.0|0.6|1.31||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, type of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.31|0.60|0.54
91622634|NCT01594333|183137940|SUPERIORITY||Cox Proportional Hazard|0.98||||0.8|TWO_SIDED|95.0|0.84|1.14||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time since qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.14|0.84|0.80
91622635|NCT01594333|183137942|SUPERIORITY||Cox Proportional Hazard|0.81||||0.31|TWO_SIDED|95.0|0.53|1.22||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.22|0.53|0.31
91622636|NCT01594333|183137943|SUPERIORITY||Cox Proportional Hazard|0.92||||0.38|TWO_SIDED|95.0|0.75|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.75|0.38
91622637|NCT00589979|183137948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||0.1006||95.0|0.89|3.55||All statistical tests were 2-sided with a significance level of alpha=0.05.|Cox frailty model|Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.|The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.|The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.||3.55|0.89|0.1006
91622638|NCT00589979|183137950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.1272||95.0|0.86|4.02||The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.|Regression, Logistic|The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.||4.02|0.86|0.1272
91660875|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.52|2.72||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.72|1.52|<0.001
91660876|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.11|0.91|<0.001
91660877|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|||<|0.001|TWO_SIDED|95.0|1.34|2.55||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.55|1.34|<0.001
91660878|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.79|1.59|<0.001
91660879|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|0.97|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.16|0.97|<0.001
91660880|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.28|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.52|1.28|<0.001
91660881|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.75||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.75|1.52|<0.001
91660882|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED|95.0|0.98|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.20|0.98|<0.001
91660883|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.26|2.54||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.54|1.26|<0.001
91660884|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.39|2.66||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.66|1.39|<0.001
91660885|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|0.81|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.07|0.81|<0.001
91660886|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83|||<|0.001|TWO_SIDED|95.0|1.17|2.49||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.49|1.17|<0.001
91660887|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|||<|0.001|TWO_SIDED|95.0|1.13|2.43||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.43|1.13|<0.001
91713570|NCT01401543|183318634|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.86|0.95|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.95|0.86|
91660888|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.78|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.07|0.78|<0.001
91660889|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||<|0.001|TWO_SIDED|95.0|0.95|2.32||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.32|0.95|<0.001
91660890|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|0.94|2.29||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.29|0.94|<0.001
91525076|NCT01986101|182925455|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.223|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.9|0.223
91660891|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.71|2.06||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.06|0.71|<0.001
91660892|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|0.88|2.27||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.27|0.88|<0.001
91660893|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.73|2.1||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.10|0.73|<0.001
91660894|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001|TWO_SIDED|95.0|0.72|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.08|0.72|<0.001
91660895|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.53|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.96|0.53|<0.001
91660896|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.003|TWO_SIDED|95.0|0.38|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.79|0.38|0.003
91660897|NCT00913627|183216465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||2.02|0.61|<0.001
91660898|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.011|TWO_SIDED|95.0|0.12|0.91||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.91|0.12|0.011
91660899|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.028|TWO_SIDED|95.0|0.05|0.83||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.83|0.05|0.028
91660900|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.048|TWO_SIDED|95.0|0.0|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.78|0.00|0.048
91660901|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.69|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.96|0.69|<0.001
91660902|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.45|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.71|0.45|<0.001
91660903|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.002|TWO_SIDED|95.0|0.38|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.63|0.38|0.002
91660904|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.46|3.06||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||3.06|1.46|<0.001
91660905|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.24|2.82||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.82|1.24|<0.001
91660906|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.74|2.31||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.31|0.74|<0.001
91622639|NCT00589979|183137951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.0224||95.0|-1.01|-0.08||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.08|-1.01|0.0224
91622640|NCT00589979|183137952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.2747||95.0|-0.31|1.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects regression||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||1.09|-0.31|0.2747
91622641|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4498||95.0|-0.8|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.80|0.4498
91622642|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.1065||95.0|-1.11|0.11||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.11|-1.11|0.1065
91622643|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.0484||95.0|-0.94|0.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.00|-0.94|0.0484
91660907|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.78|3.5||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.50|1.78|<0.001
91660908|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||<|0.001|TWO_SIDED|95.0|1.81|3.51||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.51|1.81|<0.001
91660909|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16|||<|0.001|TWO_SIDED|95.0|1.32|3.0||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.00|1.32|<0.001
91660910|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001|TWO_SIDED|95.0|2.39|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.12|2.39|<0.001
91660911|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||<|0.001|TWO_SIDED|95.0|2.57|4.28||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.28|2.57|<0.001
91660912|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.77|||<|0.001|TWO_SIDED|95.0|1.92|3.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||3.63|1.92|<0.001
91660913|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.7|4.44||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.44|2.70|<0.001
91660914|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.53|2.82|<0.001
91660915|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001|TWO_SIDED|95.0|1.87|3.57||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||3.57|1.87|<0.001
91660916|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|||<|0.001|TWO_SIDED|95.0|3.27|4.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.99|3.27|<0.001
91660917|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001|TWO_SIDED|95.0|3.24|4.95||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.95|3.24|<0.001
91660918|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001|TWO_SIDED|95.0|2.24|3.93||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.93|2.24|<0.001
91660919|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||<|0.001|TWO_SIDED|95.0|3.36|5.13||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||5.13|3.36|<0.001
91660920|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.04|||<|0.001|TWO_SIDED|95.0|3.17|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||4.92|3.17|<0.001
91713571|NCT01401543|183318634|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.9|0.99|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.99|0.90|
91713572|NCT01401543|183318634|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.07|0.97|
91622644|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.4973||95.0|-0.93|0.46||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.46|-0.93|0.4973
91622645|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3966||95.0|-0.16|0.41||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.41|-0.16|0.3966
91660921|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|||<|0.001|TWO_SIDED|95.0|2.11|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.85|2.11|<0.001
91660922|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||<|0.001|TWO_SIDED|95.0|3.14|5.01||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||5.01|3.14|<0.001
91660923|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.001|TWO_SIDED|95.0|3.07|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||4.92|3.07|<0.001
91713573|NCT01401543|183318635|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.84|||||TWO_SIDED|90.0|0.77|0.91|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.91|0.77|
91713574|NCT01401543|183318635|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.78|||||TWO_SIDED|90.0|0.71|0.85|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.85|0.71|
91713575|NCT01401543|183318635|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.85|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.85|
91713576|NCT01401543|183318635|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.77|||||TWO_SIDED|90.0|0.7|0.84|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.84|0.70|
91713577|NCT01401543|183318635|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.84|1.0|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.00|0.84|
91660924|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.83|||<|0.001|TWO_SIDED|95.0|1.91|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.75|1.91|<0.001
91660925|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|||<|0.001|TWO_SIDED|95.0|2.78|4.71||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.71|2.78|<0.001
91713578|NCT01401543|183318635|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.08|0.91|
91713579|NCT01401543|183318636|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||||1.05|0.93|
91713580|NCT01401543|183318636|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||||1.00|0.89|
91713581|NCT01401543|183318636|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
91525077|NCT01986101|182925456|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.262||0.076|TWO_SIDED|95.0|-0.98|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-0.98|0.076
91660926|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|||<|0.001|TWO_SIDED|95.0|2.98|4.89||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.89|2.98|<0.001
91660927|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.001|TWO_SIDED|95.0|1.85|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||3.75|1.85|<0.001
91660928|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61|||<|0.001|TWO_SIDED|95.0|2.65|4.56||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.56|2.65|<0.001
91660929|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|2.89|4.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.79|2.89|<0.001
91660930|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|||<|0.001|TWO_SIDED|95.0|1.65|3.54||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||3.54|1.65|<0.001
91660931|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|||<|0.001|TWO_SIDED|95.0|2.54|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.53|2.54|<0.001
91660932|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.52|4.49||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.49|2.52|<0.001
91480950|NCT05217927|182834575|SUPERIORITY||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|97.5|-2.12|-0.71|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.||-0.71|-2.12|<0.0001
91480951|NCT05217927|182834576|SUPERIORITY||LS Mean Difference|-1.2|||=|0.0002|TWO_SIDED|97.5|-1.84|-0.47|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.||-0.47|-1.84|=0.0002
91622646|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6941||95.0|-0.53|0.35||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.35|-0.53|0.6941
91622647|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.5664||95.0|-0.45|0.82||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.82|-0.45|0.5664
91660933|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.69|3.65||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||3.65|1.69|<0.001
91660934|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.19|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.21|2.19|<0.001
91660935|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.51|4.51||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.51|2.51|<0.001
91660936|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.49|3.48||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||3.48|1.49|<0.001
91660937|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|2.17|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.21|2.17|<0.001
91660938|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|2.64|4.66||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.66|2.64|<0.001
91660939|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||<|0.001|TWO_SIDED|95.0|1.58|3.6||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||3.60|1.58|<0.001
91660940|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|||<|0.001|TWO_SIDED|95.0|2.06|4.15||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.15|2.06|<0.001
91660941|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.53|4.61||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.61|2.53|<0.001
91660942|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.61|3.67||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||3.67|1.61|<0.001
91660943|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|||<|0.001|TWO_SIDED|95.0|2.09|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.21|2.09|<0.001
91660944|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.001|TWO_SIDED|95.0|2.36|4.46||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.46|2.36|<0.001
91713582|NCT01401543|183318636|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
91660945|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.36|3.44||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||3.44|1.36|<0.001
91660946|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.03|||<|0.001|TWO_SIDED|95.0|1.94|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.12|1.94|<0.001
91660947|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|||<|0.001|TWO_SIDED|95.0|1.91|4.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.07|1.91|<0.001
91713583|NCT01401543|183318636|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
91713584|NCT01401543|183318636|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
91480952|NCT05217927|182834576|SUPERIORITY||LS Mean Difference|-2.1|||<|0.0001|TWO_SIDED|97.5|-2.78|-1.46|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with the number of total migraine days per month in the OP as a covariate; treatment group, randomization stratum (use of previous prophylactic migraine medication generally considered to have efficacy) month and month-by-treatment group interaction as fixed effects.||-1.46|-2.78|<0.0001
91480953|NCT05217927|182834577|SUPERIORITY||LS Mean Difference|-0.5|||=|0.144|TWO_SIDED|97.5|-1.2|0.25|||Mixed Models Analysis|||Linear mixed effects model with repeated measures has treatment group, randomization stratum, month, and month-by-treatment group interaction as fixed effects.||0.25|-1.20|=0.1440
91480954|NCT05217927|182834577|SUPERIORITY||LS Mean Difference|-1.3|||<|0.0001|TWO_SIDED|97.5|-1.97|-0.65|||Mixed Models Analysis|||Linear mixed effects model with repeated measures has treatment group, randomization stratum, month, and month-by-treatment group interaction as fixed effects.||-0.65|-1.97|<0.0001
91480955|NCT05217927|182834578|SUPERIORITY||LS Mean Difference|2.4|||=|0.2029|TWO_SIDED|97.5|-1.84|6.66|||Regression, Linear|||Linear regression model with treatment group and randomization stratum as fixed effects and baseline score as covariate for participants with non-missing domain scores at both baseline and Week 12.||6.66|-1.84|=0.2029
91622648|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6871||95.0|-0.55|0.37||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.37|-0.55|0.6871
91622649|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.2318||95.0|-1.08|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.08|0.2318
91622650|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3383||95.0|-0.64|0.22||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.22|-0.64|0.3383
91622651|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.874||95.0|-0.63|0.73||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.73|-0.63|0.8740
91622652|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.999||95.0|-0.54|0.54||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.54|-0.54|0.9990
91660948|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.28|3.42||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||3.42|1.28|<0.001
91660949|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.57|3.83||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.83|1.57|<0.001
91660950|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|||<|0.001|TWO_SIDED|95.0|1.62|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.85|1.62|<0.001
91660951|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.14|3.37||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.37|1.14|<0.001
91660952|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.51|3.76||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.76|1.51|<0.001
91660953|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.33|3.56||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.56|1.33|<0.001
91660954|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.36|||<|0.001|TWO_SIDED|95.0|1.25|3.47||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.47|1.25|<0.001
91660955|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||<|0.001|TWO_SIDED|95.0|0.86|3.19||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.19|0.86|<0.001
91622653|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.4183||95.0|-0.85|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.85|0.4183
91622654|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.8227||95.0|-0.71|0.57||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.57|-0.71|0.8227
91622655|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.587||95.0|-0.48|0.85||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.85|-0.48|0.5870
91622656|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2181||95.0|-1.15|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.15|0.2181
91622657|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.6276||95.0|-0.68|0.42||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.42|-0.68|0.6276
91660956|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.001|TWO_SIDED|95.0|0.75|3.05||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.05|0.75|0.001
91660957|NCT00913627|183216466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.05|3.34||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.34|1.05|<0.001
91660958|NCT00913627|183216467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42|||<|0.001|TWO_SIDED|95.0|1.94|2.89||p-value adjusted for baseline PSR and gender|ANOVA|||||2.89|1.94|<0.001
91660959|NCT00913627|183216467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.001|TWO_SIDED|95.0|1.92|2.86||p-value adjusted for baseline PSR and gender|ANOVA|||||2.86|1.92|<0.001
91660960|NCT00913627|183216467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||<|0.001|TWO_SIDED|95.0|1.58|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||||2.52|1.58|<0.001
91660961|NCT00095212|183216484|SUPERIORITY_OR_OTHER|||||||0.04|||||||longitudinal linear mixed effects model|||||||0.04
91660962|NCT00095212|183216485|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal linear mixed effects model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
91660963|NCT00095212|183216486|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
91660964|NCT00095212|183216487|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.01
91660965|NCT00095212|183216488|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
91660966|NCT00095212|183216489|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||||||0.29
91660967|NCT00095212|183216490|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared|||||||0.75
91660968|NCT00095212|183216491|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
91660969|NCT00095212|183216492|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
91660970|NCT00095212|183216493|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
91713585|NCT01401543|183318637|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.72|||||TWO_SIDED|90.0|0.68|0.77|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.77|0.68|
91660971|NCT00095212|183216494|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
91660972|NCT00017953|183216495|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.51|TWO_SIDED|95.0|0.83|1.09|||Regression, Cox|||||1.09|0.83|0.51
91660973|NCT00017953|183216496|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.42|TWO_SIDED|95.0|0.79|1.1|||Regression, Cox|||||1.10|0.79|0.42
91660974|NCT00017953|183216497|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.23|TWO_SIDED|95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.23
91660975|NCT00017953|183216498|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.29|TWO_SIDED|95.0|0.84|1.05|||Regression, Cox|||||1.05|0.84|0.29
91660976|NCT02374853|183216499|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
91480956|NCT05217927|182834578|SUPERIORITY||LS Mean Difference|10.1|||<|0.0001|TWO_SIDED|97.5|5.71|14.52|||Regression, Linear|||Linear regression model with treatment group and randomization stratum as fixed effects and baseline score as covariate for participants with non-missing domain scores at both baseline and Week 12.||14.52|5.71|<0.0001
91622658|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.0917||95.0|-1.23|0.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.09|-1.23|0.0917
91660977|NCT02374853|183216500|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
91660978|NCT02374853|183216501|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||.054
91660979|NCT00762307|183216513|OTHER||Mean Difference (Net)|18.7|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|14.9|22.4||||||||22.4|14.9|
91660980|NCT00762307|183216515|OTHER||sucess percentage|91.9|STANDARD_ERROR_OF_MEAN|5.2|||ONE_SIDED|||||||||||||
91660981|NCT00837486|183216535|SUPERIORITY_OR_OTHER||||||=|0.53||||||"one-sided P-value~per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%"|Fisher Exact|||The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.||||=0.53
91660982|NCT01754597|183216573|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
91660983|NCT01754597|183216574|SUPERIORITY|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
91660984|NCT01754597|183216575|SUPERIORITY|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
91660985|NCT02635750|183216581|OTHER||Adjusted gMean ratio(%)|99.95|||||TWO_SIDED|90.0|89.502|111.62|||||"Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+ don / BI 409306).~Intra-individual coefficient of variation (gCV (%)) = 18.6."|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||111.62|89.502|
91660986|NCT02635750|183216582|OTHER||Adjusted gMean ratio(%)|100.82|||||TWO_SIDED|90.0|81.861|124.17|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don / BI 409306). Intra-individual coefficient of variation (gCV (%)) = 35.8.|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||124.17|81.861|
91660987|NCT02635750|183216583|OTHER||Adjusted gMean ratio (%)|100.84|||||TWO_SIDED|90.0|97.584|104.19|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 4.9.|The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||104.19|97.584|
91660988|NCT02635750|183216584|OTHER||Adjusted gMean ratio(%)|113.08|||||TWO_SIDED|90.0|106.41|120.15|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone. (BI 409306+don / don) Intra-individual coefficient of variation (gCV (%)) = 9.0.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||120.15|106.41|
91660989|NCT02635750|183216585|OTHER||Adjusted gMean ratio(%)|100.01|||||TWO_SIDED|90.0|89.549|111.68|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don/ BI 409306). Intra-individual coefficient of variation (gCV(%)) = 18.6.|The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||111.68|89.549|
91660990|NCT02635750|183216586|OTHER||Adjusted gMean ratio(%)|98.38|||||TWO_SIDED|90.0|93.413|103.6|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 7.7.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||103.60|93.413|
91660991|NCT00461786|183216689|SUPERIORITY_OR_OTHER||Overall Response Rate|21.0||||||95.0|10.5|35.0||||||Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.||35.0|10.5|
91622659|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2089||95.0|-1.13|0.25||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.25|-1.13|0.2089
91622660|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4188||95.0|-0.75|0.31||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.31|-0.75|0.4188
91622661|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.6959||95.0|-0.32|0.21||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.21|-0.32|0.6959
91622662|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.4806||95.0|-0.64|0.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.30|-0.64|0.4806
91622663|NCT00589979|183137953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2291||95.0|-0.74|0.18||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.18|-0.74|0.2291
91622664|NCT00589979|183137954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.3185||95.0|0.77|2.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.27|0.77|0.3185
91622665|NCT00589979|183137955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4748||95.0|0.72|2.06||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.06|0.72|0.4748
91660992|NCT00834418|183216722|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|99.6|116.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116|99.6|
91660993|NCT00834418|183216723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|95.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|95.2|
91660994|NCT01705574|183216724|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.|Difference in proportions|6.5|||||TWO_SIDED|95.2|0.4|12.6|||||Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.|||12.6|0.4|
91713586|NCT01401543|183318637|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.71|||||TWO_SIDED|90.0|0.66|0.76|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.76|0.66|
91660995|NCT01705574|183216724|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|6.5||||0.034|TWO_SIDED|95.2|0.4|12.6|||Cochran-Mantel-Haenszel|P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.|Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was \> 0, superiority of STB over ATV+RTV+TVD was established.|If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.||12.6|0.4|0.034
91622666|NCT00589979|183137956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.7839||95.0|-0.74|0.98||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.98|-0.74|0.7839
91622667|NCT00589979|183137958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.3773||95.0|-0.02|0.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.04|-0.02|0.3773
91622668|NCT00589979|183137959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2605||95.0|0.38|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.38|0.2605
91622669|NCT00589979|183137960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3193||95.0|0.44|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.44|0.3193
91622670|NCT00589979|183137961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.1378||95.0|-0.57|4.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates||4.04|-0.57|0.1378
91622671|NCT00589979|183137962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.6833||95.0|0.47|1.65||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Logistic|An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|||1.65|0.47|0.6833
91622672|NCT00589979|183137963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.16||||0.1143||95.0|-5.48|49.8||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||49.8|-5.48|0.1143
91622673|NCT00589979|183137963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.9108||95.0|-19.8|22.2||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||22.2|-19.8|0.9108
91713587|NCT01401543|183318637|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.05|0.92|
91525078|NCT01986101|182925456|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.269||0.075|TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-1.01|0.075
91480957|NCT00472459|182834607|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.514||||0.012|TWO_SIDED|95.0|0.116|0.911|||t-test, 2 sided||The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson.|||0.911|0.116|0.0120
91622674|NCT00589979|183137963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31||||0.3769||95.0|-10.3|27.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||27.0|-10.3|0.3769
91622675|NCT03373110|183137969|OTHER|||||||0.973||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models fit via maximum likelihood to examine the effect of the interventions on daily steps. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction. We used separate models to assess the intervention effects across the 8-week intervention period as well as the complete 16-week follow-up period.|The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.973
91622676|NCT03373110|183137969|OTHER|||||||0.005||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.005
91622677|NCT03373110|183137969|OTHER|||||||0.004||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.004
91622678|NCT03373110|183137969|OTHER|||||||0.627||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.627
91622679|NCT03373110|183137969|OTHER|||||||0.359||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.359
91622680|NCT03373110|183137969|OTHER|||||||0.597||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.597
91622681|NCT02553317|183137983|SUPERIORITY||||||=|0.0099||||||The resulting p-value was compared with a significance level of 5%.|Log Rank|||Time to platelet count response in the caplacizumab arm and placebo arm was compared by conducting a two-sided stratified log-rank test based on a KM analysis, with severity of neurological involvement (according to the Glasgow coma scale \[GCS\] category, stratification factor used in randomization: ≤12 / 13-15) as stratification factor.||||= 0.0099
91713588|NCT01401543|183318637|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.69|||||TWO_SIDED|90.0|0.65|0.74|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.74|0.65|
91622682|NCT02553317|183137983|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.095|2.195|||||The HR was estimated from a Cox proportional Hazards regression model.|Time to platelet count response was analyzed using a Cox proportional hazards regression model with time to platelet count response as dependent variable, and treatment group and GCS category as independent variables. The hazard (or platelet count normalization rate) ratio from the Cox model was reported along with 95% CI.||2.195|1.095|
91622683|NCT02553317|183137984|SUPERIORITY||||||<|0.0001||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was conducted with adjustment for GCS category (stratification factor used in randomization).||||< 0.0001
91622684|NCT02553317|183137985|SUPERIORITY||||||=|0.0004||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0004
91622685|NCT02553317|183137986|SUPERIORITY||||||=|0.0572||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0572
91622686|NCT01599754|183138004|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3211|TWO_SIDED|95.0|0.66|1.147|||Log Rank|||||1.147|0.660|0.3211
91622687|NCT01599754|183138005|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9246|TWO_SIDED|95.0|0.6|1.756|||Log Rank|||||1.756|0.600|0.9246
91622688|NCT00753935|183138019|SUPERIORITY|||||||0.005|||||||Wilcoxon rank-sum|||||||0.005
91622689|NCT03282357|183138028|NON_INFERIORITY|Non-inferiority margin, delta = 10 percent (%). The two-sided 95% confidence interval (CI) for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-6.8|||||TWO_SIDED|95.0|-13.1|-0.5||||||||-0.5|-13.1|
91622690|NCT03282357|183138029|NON_INFERIORITY|Non-inferiority margin, delta = 15%. The two-sided 95% CI for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-4.9|||||TWO_SIDED|95.0|-9.8|-0.3||||||||-0.3|-9.8|
91622691|NCT00594204|183138041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001||95.0|2.97|7.68||p-values are obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||7.68|2.97|<0.0001
91622692|NCT00594204|183138042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001||95.0|3.3|7.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 12||7.5|3.3|<0.0001
91622693|NCT00594204|183138042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001||95.0|2.8|6.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 24||6.5|2.8|<0.0001
91660996|NCT00777023|183216729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.61|STANDARD_ERROR_OF_MEAN|0.53||0.0024|TWO_SIDED|97.5|-2.8|-0.42||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.42|-2.80|0.0024
91660997|NCT00777023|183216729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.52||0.004|TWO_SIDED|97.5|-2.69|-0.33||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.33|-2.69|0.0040
91713589|NCT01401543|183318637|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.02|0.90|
91713590|NCT01401543|183318637|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.04|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.04|0.91|
91713591|NCT00069823|183318638|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.2||||0.35|TWO_SIDED|95.0|0.8|2.0||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||2.0|0.8|0.35
91622694|NCT00594204|183138043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.0001||95.0|3.74|8.88|||Regression, Logistic|p-value are obtained from a logistic regression model including the main effects of treatment and country|Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||8.88|3.74|<0.0001
91622695|NCT01369212|183138050|SUPERIORITY|||||||0.72|||||||Wald test|Proportion with HBsAg loss at week 240 in each group is estimated by Kaplan-Meier and then equality of proportion is tested using Wald test.||||||0.72
91622696|NCT01369212|183138051|SUPERIORITY|||||||0.09||||||The cumulative percentages with HBsAg loss at week 192 were estimated using Kaplan-Meier method and then the equality is tested using Wald test.|Wald Test|||||||0.09
91622697|NCT01369212|183138052|SUPERIORITY|||||||0.46|||||||Fisher Exact|||||||0.46
91622698|NCT01369212|183138053|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91622699|NCT01369212|183138054|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91622700|NCT01369212|183138055|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
91622701|NCT01369212|183138056|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
91622702|NCT01369212|183138057|SUPERIORITY|||||||0.44|||||||Fisher Exact|||||||0.44
91622703|NCT01369212|183138058|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
91622704|NCT01369212|183138059|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
91622705|NCT01369212|183138060|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
91622706|NCT01369212|183138061|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
91622707|NCT01369212|183138062|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91622708|NCT01369212|183138063|SUPERIORITY|||||||0.87|||||||Fisher Exact|||||||0.87
91622709|NCT01369212|183138064|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
91622710|NCT01369212|183138065|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
91622711|NCT01369212|183138067|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
91622712|NCT01369212|183138068|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
91622713|NCT01016678|183138104|SUPERIORITY_OR_OTHER||Difference in percentages|18.0||||0.0038|TWO_SIDED||||||Chi-squared|||Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)||||0.0038
91622714|NCT01016678|183138105|SUPERIORITY_OR_OTHER||difference in percentages|8.0||||0.1294|TWO_SIDED||||||Chi-squared|||||||0.1294
91622715|NCT00168064|183138137|NON_INFERIORITY_OR_EQUIVALENCE|The PG formulation was determined to be non-inferior to the AP formulation if the lower limit of the 95% confidence interval around the ratio of the response rates (PG/AP) was \> = 0.75.|ratio of proportions|1.226|||||TWO_SIDED|95.0|0.974|1.552|||ANCOVA||ratio is response rate of PG formulation divided by response rate of AP formulation|||1.552|0.974|
91622716|NCT03428997|183138146|EQUIVALENCE|Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect|Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.274|||||||2-sided t-test|||Testing hypothesis is that the mean score is equal between the compared treatments.||||0.274
91622717|NCT02802878|183138207|SUPERIORITY|||||||0.67||||||Adjusted for two observations per subject.|Regression, Linear|Side treated as a repeated factor||||||.67
91622718|NCT03970395|183138234|SUPERIORITY||Risk Ratio (RR)|7.66||||0.01|TWO_SIDED|95.0|2.46|23.84||The threshold for statistical significance was p\<0.5|Risk Ratio (RR)||Risk Difference 0.41 (IC 95; 0.25-0.53)|||23.84|2.46|0.01
91622719|NCT03970395|183138235|SUPERIORITY||Risk Ratio (RR)|5.6||||0.01|TWO_SIDED|95.0|2.36|13.27|||Relative Risk (RR)||Risk Difference 0.47 (IC 95; 0.31-0.64)|||13.27|2.36|0.01
91622720|NCT03970395|183138236|SUPERIORITY||Risk Ratio (RR)|7.49||||0.01|TWO_SIDED|95.0|2.42|23.18|||Risk Ratio (RR)||Risk Difference 0.44 (IC 95%; 0.27-0.60)|||23.18|2.42|0.01
91622721|NCT03970395|183138237|SUPERIORITY||Risk Ratio (RR)|4.91||||0.01|TWO_SIDED|95.0|2.12|11.38|||Risk Ratio (RR)||Risk Difference 0.54 (IC 95; 0.36-0.72)|||11.38|2.12|0.01
91622722|NCT01906866|183138252|SUPERIORITY||Mean Difference (Final Values)|32.32|STANDARD_ERROR_OF_MEAN|15.1|=|0.035|TWO_SIDED|95.0|2.38|62.26|||Mixed Models Analysis|||||62.26|2.38|=0.035
91622723|NCT01906866|183138253|SUPERIORITY||Mean Difference (Final Values)|-25.2|STANDARD_ERROR_OF_MEAN|9.787|=|0.011|TWO_SIDED|95.0|-44.61|-5.8|||Mixed Models Analysis|||||-5.8|-44.61|=0.011
91622724|NCT01906866|183138256|SUPERIORITY|||||||0.053|||||||MMRM|||Mixed Models for Repeated Measures (MMRM) analysis||||0.053
91622725|NCT01906866|183138256|SUPERIORITY|||||||0.039|||||||MI analysis|||||||0.039
91622726|NCT01906866|183138258|SUPERIORITY|||||||0.077|||||||MMRM|||||||0.077
91622727|NCT01906866|183138259|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
91622728|NCT01529385|183138306|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622729|NCT01529385|183138307|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<0.05
91622730|NCT01529385|183138308|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<.05
91622731|NCT01529385|183138309|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622732|NCT01529385|183138310|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622733|NCT01529385|183138311|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622734|NCT01529385|183138313|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622735|NCT01529385|183138314|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622736|NCT01529385|183138315|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
91622737|NCT01401465|183138316|SUPERIORITY_OR_OTHER||Slope|88.235|||<|0.0001||||||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Two-sided Signed Rank Test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Total Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. For the primary endpoint of the Total Preference Score, assuming an SD of 40, a sample size of 155 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.025 two-sided significance level.||||<0.0001
91622738|NCT01401465|183138317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||<|0.0001|TWO_SIDED|95.0|11.22|16.58||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline.||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||16.58|11.22|<0.0001
91622739|NCT01401465|183138317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|2.2|7.56||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||7.56|2.20|<0.0001
91622740|NCT01401465|183138318|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|88.889|||<|0.0001||||||If both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|Two-sided signed-rank test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Treatment Process Composite Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. Assuming an SD of 40, as observed in Study 060-301, a sample size of 128 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.05 two-sided significant level||||<0.0001
91713592|NCT00069823|183318639|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.79|TWO_SIDED|95.0|0.6|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.6|0.79
91713593|NCT00069823|183318640|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.1||||0.66|TWO_SIDED|95.0|0.8|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.8|0.66
91622741|NCT01401465|183138319|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CI of the LS mean difference of ciclesonide nasal aerosol minus mometasone aqueous nasal spray was calculated from the ANCOVA model, and the upper bound of the CI was compared to the non-inferiority margin of 0.5. Non-inferiority was declared if the upper bound of the 95% CI of this difference was \< 0.5.|Difference in LS Means|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||f both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|ANCOVA|Site, treatment, period, treatment sequence as fixed effects, subject nested within sequence as a random effect, and baseline rTNSS as a covariate.|Ciclesonide 74 mcg minus Mometasone 200 mcg|The null hypothesis is that the change from baseline in rTNSS for ciclesonide 74 mcg nasal aerosol minus the change from baseline in rTNSS for mometasone AQ 200 mcg is greater than 0.5.||0.1|-0.3|
91622742|NCT01115738|183138347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.24||||0.188|TWO_SIDED|95.0|-10.98|55.47||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||55.47|-10.98|0.188
91622743|NCT01115738|183138347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93||||0.809|TWO_SIDED|95.0|-28.2|36.07||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||36.07|-28.20|0.809
91622744|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93||||0.37|TWO_SIDED|95.0|-20.26|54.12||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||54.12|-20.26|0.370
91622745|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.89||||0.052|TWO_SIDED|95.0|-0.29|72.06||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||72.06|-0.29|0.052
91622746|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.703|TWO_SIDED|95.0|-39.55|58.45||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||58.45|-39.55|0.703
91622747|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||0.823|TWO_SIDED|95.0|-42.53|53.44||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||53.44|-42.53|0.823
91622748|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.69||||0.054|TWO_SIDED|95.0|-0.47|57.84||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||57.84|-0.47|0.054
91622749|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.436|TWO_SIDED|95.0|-17.29|39.9||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||39.90|-17.29|0.436
91622750|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.87||||0.463|TWO_SIDED|95.0|-14.96|32.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||32.71|-14.96|0.463
91622751|NCT01115738|183138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34||||0.777|TWO_SIDED|95.0|-26.62|19.94||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||19.94|-26.62|0.777
91480958|NCT00472459|182834608|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.413||||0.1761|TWO_SIDED|95.0|-0.19|1.016|||t-test, 2 sided|||||1.016|-0.190|0.1761
91480959|NCT00472459|182834609|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.6||||0.1183|TWO_SIDED|95.0|-0.156|1.357|||t-test, 2 sided|||||1.357|-0.156|0.1183
91480960|NCT00472459|182834610|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.493||||0.2322|TWO_SIDED|95.0|-0.323|1.309|||t-test, 2 sided|||||1.309|-0.323|0.2322
91480961|NCT00472459|182834611|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.68||||0.1286|TWO_SIDED|95.0|-0.202|1.562|||t-test, 2 sided|||||1.562|-0.202|0.1286
91480962|NCT00478881|182834624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.045||||0.5293||95.0|-33.194|17.104||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P\<0.05.|ANCOVA||Placebo-Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||17.104|-33.194|0.5293
91622752|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31||||0.505|TWO_SIDED|95.0|-13.1|6.48||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||6.48|-13.10|0.505
91622753|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23||||0.278|TWO_SIDED|95.0|-14.74|4.27||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.27|-14.74|0.278
91622754|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.749|TWO_SIDED|95.0|-19.44|14.02||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||14.02|-19.44|0.749
91622755|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.89|TWO_SIDED|95.0|-15.24|17.53||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||17.53|-15.24|0.890
91622756|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89||||0.223|TWO_SIDED|95.0|-18.02|4.24||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.24|-18.02|0.223
91622757|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.808|TWO_SIDED|95.0|-9.44|12.1||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||12.10|-9.44|0.808
91622758|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07||||0.049|TWO_SIDED|95.0|-20.11|-0.04||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||-0.04|-20.11|0.049
91622759|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.99||||0.842|TWO_SIDED|95.0|-10.85|8.86||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.86|-10.85|0.842
91622760|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03||||0.247|TWO_SIDED|95.0|-13.58|3.52||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||3.52|-13.58|0.247
91622761|NCT01115738|183138351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.942|TWO_SIDED|95.0|-8.09|8.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.71|-8.09|0.942
91622762|NCT01115738|183138354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.449||||0.8711|TWO_SIDED|95.0|-38.81|45.71|||ANOVA|||A linear ANOVA model with PRU values at baseline for clopidogrel treated participants as response and CYP2C19 metabolizer status as covariate of main interest.||45.71|-38.81|0.8711
91622763|NCT01115738|183138355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.714||||0.7875|TWO_SIDED|95.0|-72.78|55.36|||ANOVA|||A linear ANOVA model with PRU values of 6 hours post Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||55.36|-72.78|0.7875
91660998|NCT00777023|183216730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.51||0.0024|TWO_SIDED|97.5|-2.72|-0.41||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||-0.41|-2.72|0.0024
91660999|NCT00777023|183216730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.51||0.0281|TWO_SIDED|97.5|-2.26|0.02||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||0.02|-2.26|0.0281
91661000|NCT00777023|183216731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0608|TWO_SIDED|97.5|-0.32|-0.03||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.03|-0.32|0.0608
91661001|NCT00777023|183216731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|97.5|-0.45|-0.11||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.11|-0.45|0.0003
91661002|NCT00777023|183216732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.028|TWO_SIDED|97.5|-0.43|0.0||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||0.00|-0.43|0.0280
91661003|NCT00777023|183216732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0026|TWO_SIDED|97.5|-0.51|-0.07||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||-0.07|-0.51|0.0026
91661004|NCT02678286|183216738|SUPERIORITY|||||||0.0145|||||||t-test, 2 sided|||||||0.0145
91661005|NCT02678286|183216739|SUPERIORITY|||||||0.1841||||||Row 1 (SPID6)|t-test, 2 sided|||||||0.1841
91525079|NCT01986101|182925457|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|95.0|-3.1|-0.3|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.3|-3.1|0.016
91661006|NCT02678286|183216739|SUPERIORITY|||||||0.0434||||||Row 2 (SPID12)|t-test, 2 sided|||||||0.0434
91661007|NCT02678286|183216739|SUPERIORITY|||||||0.004||||||Row 3 (SPID48)|t-test, 2 sided|||||||0.0040
91661008|NCT02678286|183216739|SUPERIORITY|||||||0.0028||||||Row 4 (SPID24-48)|t-test, 2 sided|||||||0.0028
91661009|NCT02678286|183216740|SUPERIORITY|||||||0.7572|||||||Log Rank|||||||0.7572
91661010|NCT02678286|183216741|SUPERIORITY|||||||0.6559||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||0.6559
91661011|NCT02678286|183216741|SUPERIORITY|||||||0.0014||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||0.0014
91661012|NCT02678286|183216741|SUPERIORITY|||||||0.4994||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||0.4994
91661013|NCT02678286|183216742|SUPERIORITY|||||||0.0275||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0275
91661014|NCT02678286|183216742|SUPERIORITY|||||||0.0009||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0009
91661015|NCT02678286|183216742|SUPERIORITY|||||||0.0027||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0027
91661016|NCT02678286|183216743|SUPERIORITY|||||||0.005|||||||Log Rank|||||||0.0050
91661017|NCT02678286|183216744|SUPERIORITY|||||||0.5096|||||||Log Rank|||||||0.5096
91661018|NCT02678286|183216745|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
91661019|NCT02678286|183216746|SUPERIORITY|||||||0.0178|||||||Cochran-Mantel-Haenszel|||||||0.0178
91661020|NCT02678286|183216747|SUPERIORITY|||||||0.1888|||||||Cochran-Mantel-Haenszel|||||||0.1888
91661021|NCT02678286|183216748|SUPERIORITY|||||||0.0788|||||||Cochran-Mantel-Haenszel|||||||0.0788
91661022|NCT02678286|183216749|SUPERIORITY|||||||0.0607|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0607
91661023|NCT02678286|183216750|SUPERIORITY|||||||0.0027|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0027
91661024|NCT04274686|183216751|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.667|TWO_SIDED|95.0|-7.0|10.7|||Paired t-test|||Null hypothesis: No difference in percent air leakage||10.7|-7.0|0.667
91661025|NCT04274686|183216752|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.218|TWO_SIDED|95.0|-0.7|2.9|||Paired t-test|||||2.90|-0.70|0.218
91661026|NCT04274686|183216753|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.455|TWO_SIDED|95.0|-0.5|0.2|||Paired t-test|||||0.2|-0.5|0.455
91661027|NCT02647944|183216769|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91661028|NCT02647944|183216770|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91661029|NCT02647944|183216771|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91661030|NCT02647944|183216772|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||||||0.069
91661031|NCT02647944|183216773|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.054
91661032|NCT02647944|183216774|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91661033|NCT02647944|183216775|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91661034|NCT02647944|183216776|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91622764|NCT01115738|183138355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.435||||0.8913|TWO_SIDED|95.0|-53.23|46.37|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||46.37|-53.23|0.8913
91622765|NCT01115738|183138355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.6229|TWO_SIDED|95.0|-35.43|58.83|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||58.83|-35.43|0.6229
91661035|NCT01860521|183216836|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91661036|NCT01860521|183216837|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
91661037|NCT01860521|183216838|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
91661038|NCT01860521|183216839|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
91661039|NCT01513174|183216856|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.124|TWO_SIDED|95.0|1.0|1.92|||Log Rank||||The initial hypothesis estimated that the median PFS for the gefitinib group would be 10 months, while the median PFS for the gefitinib/olaparib group would be 16 months, which implied a hazard ratio (HR) of 1.6.|1.92|1.00|0.124
91661040|NCT01513174|183216857|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3455|TWO_SIDED|95.0|0.806|1.845|||Log Rank|||||1.845|0.806|0.3455
91713594|NCT00069823|183318641|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62|TWO_SIDED|95.0|0.6|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.6|0.62
91622766|NCT04009213|183138361|NON_INFERIORITY|H0: δT - δC ≥ 0.9 Ha: δT - δC \< 0.9|||||<|0.025|ONE_SIDED|95.0|||||ANCOVA|||||||< 0.025
91661041|NCT02576938|183216889|SUPERIORITY||||||=|0.065|||||||Chi-squared|||||||=0.065
91661042|NCT02576938|183216889|SUPERIORITY||||||=|0.027|||||||Chi-squared|||||||=0.027
91622767|NCT04009213|183138362|NON_INFERIORITY|H0: qT - qC ≥ 10% H1: qT - qC \< 10%|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
91661043|NCT00244764|183216933|SUPERIORITY_OR_OTHER||percentage|34.7||||||95.0|28.4|40.9|||||The estimated value provided is the response rate.|||40.9|28.4|
91713595|NCT00069823|183318642|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.0||||0.87|TWO_SIDED|95.0|0.8|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.8|0.87
91622768|NCT04009213|183138363|NON_INFERIORITY|H0: pC - pT ≥ 10% H1: pC - pT \< 10%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||<0.025
91661044|NCT00244764|183216934|SUPERIORITY_OR_OTHER||percentage|42.0||||||95.0|29.0|54.0|||||The estimated value is the percentage of the first 60 participants who had stable disease at Week 12, as assessed by the investigator.|||54|29|
91661045|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.728||||0.0008|TWO_SIDED|95.0|-4.219|-1.236|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||-1.236|-4.219|0.0008
91661046|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.325||||0.0021|TWO_SIDED|95.0|-3.735|-0.916|||ANCOVA|||Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.916|-3.735|0.0021
91661047|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.402||||0.0021|TWO_SIDED|95.0|-3.862|-0.942|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.942|-3.862|0.0021
91661048|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.556||||0.0382|TWO_SIDED|95.0|0.09|3.021|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||3.021|0.090|0.0382
91622769|NCT04009213|183138364|NON_INFERIORITY|H0: πC - πT ≥ 15% H1: πC - πT \< 15%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
91661049|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.958||||0.0132|TWO_SIDED|95.0|0.439|3.477|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||3.477|0.439|0.0132
91661050|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.881||||0.0161|TWO_SIDED|95.0|0.373|3.389|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||3.389|0.373|0.0161
91661051|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.592||||0.0001|TWO_SIDED|95.0|-5.162|-2.022|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.022|-5.162|0.0001
91661052|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||0|TWO_SIDED|95.0|-5.304|-2.337|||ANCOVA|||Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.337|-5.304|0.0000
91661053|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.887||||0.0006|TWO_SIDED|95.0|-4.424|-1.35|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||-1.350|-4.424|0.0006
91661054|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.953||||0.0005|TWO_SIDED|95.0|1.411|4.496|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||4.496|1.411|0.0005
91661055|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.725||||0.0015|TWO_SIDED|95.0|1.126|4.324|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||4.324|1.126|0.0015
91661056|NCT00575159|183216952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.659||||0.0001|TWO_SIDED|95.0|2.071|5.246|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||5.246|2.071|0.0001
91661057|NCT02648438|183217007|SUPERIORITY_OR_OTHER||Geometric mean ratio|62.61|||||TWO_SIDED|90.0|53.01|73.94|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||73.94|53.01|
91713596|NCT00069823|183318643|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62||95.0|0.7|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.7|0.62
91480963|NCT00478881|182834625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.668||||0.0575||95.0|-0.021|1.358||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P \<0.05.|ANCOVA||Placebo - Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||1.358|-0.021|0.0575
91480964|NCT00478881|182834626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.657||||0.8533||95.0|-6.335|7.65||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||7.650|-6.335|0.8533
91622770|NCT02702011|183138380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|65.1|STANDARD_ERROR_OF_MEAN|10.81|<|0.0001|TWO_SIDED|95.0|43.29|86.9|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 2.5 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||86.90|43.29|<0.0001
91622771|NCT02702011|183138380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.19|STANDARD_ERROR_OF_MEAN|11.1|<|0.0001|TWO_SIDED|95.0|58.8|103.58|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 10 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||103.58|58.80|<0.0001
91622772|NCT02702011|183138380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.11|STANDARD_ERROR_OF_MEAN|11.01|<|0.0001|TWO_SIDED|95.0|75.91|120.31|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 25 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||120.31|75.91|<0.0001
91622773|NCT02921763|183138389|SUPERIORITY||||||=|0.0533|||||||Sign test|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst, the values before treatment initiation and at last observation were compared, frequency of increase and decrease was summarized and the sign test was performed separately in the efficacy analysis set and study completers."||||=0.0533
91622774|NCT02921763|183138391|SUPERIORITY||||||=|0.7328|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.7328
91622775|NCT02921763|183138391|SUPERIORITY||||||=|0.1193|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.1193
91622776|NCT02921763|183138392|SUPERIORITY|||||||0.7221|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.7221
91622777|NCT02921763|183138392|SUPERIORITY|||||||0.0861|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.0861
91622778|NCT02921763|183138396|SUPERIORITY||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0020
91622779|NCT02921763|183138396|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0001
91622780|NCT02921763|183138396|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
91622781|NCT02921763|183138396|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
91622782|NCT02921763|183138396|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
91661058|NCT02648438|183217008|SUPERIORITY_OR_OTHER||Geometric mean ratio|101.15|||||TWO_SIDED|90.0|85.21|120.06|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||120.06|85.21|
91661059|NCT04405570|183217027|SUPERIORITY|||||||0.5551|||||||Log Rank|||||||0.5551
91661060|NCT04405570|183217027|SUPERIORITY|||||||0.727|||||||Log Rank|||||||0.7270
91661061|NCT04405570|183217027|SUPERIORITY|||||||0.0128|||||||Log Rank|||||||0.0128
91480965|NCT00478881|182834627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59||||0.1539||95.0|-37.057|5.876||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||5.876|-37.057|0.1539
91622783|NCT02921763|183138397|SUPERIORITY||||||=|0.0024|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0024
91622784|NCT02921763|183138397|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91622785|NCT02921763|183138397|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91622786|NCT02921763|183138397|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91622787|NCT02921763|183138397|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91622788|NCT02921763|183138398|SUPERIORITY||||||=|0.0037|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0037
91622789|NCT02921763|183138398|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91622790|NCT02921763|183138398|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91622791|NCT02921763|183138398|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
91661062|NCT04499963|183217031|SUPERIORITY|||||||0.984|||||||t-test, 2 sided|||We compared he ALSFRS-R slope (not the actual score) of the patients in our open label treatment versus the historical controls.||||0.984
91661063|NCT04499963|183217036|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91661064|NCT04499963|183217037|OTHER||||||>|0.5||||||Alpha Diversity|Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.5
91480966|NCT00478881|182834628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.374||||0.2348||95.0|-32.834|8.087||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.087|-32.834|0.2348
91622792|NCT02921763|183138398|SUPERIORITY||||||=|0.0003|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0003
91525080|NCT01986101|182925457|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.71||0.294|TWO_SIDED|95.0|-2.1|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.1|0.294
91622793|NCT02921763|183138399|SUPERIORITY||||||=|0.8035|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8035
91622794|NCT02921763|183138400|SUPERIORITY||||||=|0.8185|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8185
91622795|NCT01709981|183138414|EQUIVALENCE|Mann-Whitney||||||0.31|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.31
91622796|NCT02007954|183138432|OTHER|||||||0.01||||||P-values \< 0.05 considered statistically significant.|t-test, 2 sided|||Shapiro-Wilk test was run for normality. Baseline and follow-up AFP compared using two-tailed Student's t-test.||||.01
91661065|NCT04499963|183217038|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91661066|NCT04499963|183217039|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91661067|NCT04499963|183217040|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91661068|NCT04499963|183217041|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91661069|NCT04499963|183217042|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91480967|NCT00478881|182834629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.195||||0.3289||95.0|-24.692|8.303||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.303|-24.692|0.3289
91480968|NCT00478881|182834630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.721||||0.0609||95.0|-0.033|1.476||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||1.476|-0.033|0.0609
91622797|NCT02659605|183138436|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.572|||||||Student's t-test|||||||0.572
91622798|NCT02659605|183138437|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.849|||||||Student's t-test|||||||0.849
91622799|NCT02659605|183138438|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.886|||||||Student's t-test|||||||0.886
91622800|NCT02659605|183138439|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.612|||||||Student's t-test|||||||0.612
91661070|NCT04499963|183217043|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
91661071|NCT03117296|183217046|OTHER||Rank-Sum|0.05|||<|0.01|TWO_SIDED||||||Fisher Exact|||Univariate 2-group comparisons were performed using χ2 and Fisher's exact tests (when expected cell counts are \<5) for categorical variables, using 2-group t tests and Wilcoxon rank-sum tests (when normality distributions were violated) for continuous variables. Statistical significance was set at P \< .05. All analyses were performed using SAS 9.4 (SAS Institute, Cary, North Carolina).||||<0.01
91661072|NCT00838279|183217058|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.31||||||90.0|97.82|102.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.85|97.82|
91661073|NCT00838279|183217059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.78||||||90.0|99.09|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|99.09|
91661074|NCT00838279|183217060|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.94||||||90.0|97.4|102.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.55|97.40|
91661075|NCT04608188|183217061|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91661076|NCT04608188|183217062|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91661077|NCT04608188|183217063|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91661078|NCT04608188|183217064|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91661079|NCT01045161|183217085|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.019|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.019
91661080|NCT01045161|183217085|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
91661081|NCT01045161|183217087|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.0192|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.0192
91527723|NCT01976364|182930501|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91661082|NCT01045161|183217087|SUPERIORITY_OR_OTHER||Least Squares Mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
91661083|NCT01854047|183217089|SUPERIORITY||Least Square (LS) Mean Difference|0.21||||0.0063|TWO_SIDED|95.0|0.06|0.36||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.||0.36|0.06|0.0063
91661084|NCT01854047|183217089|SUPERIORITY||LS Mean Difference|0.26||||0.0008|TWO_SIDED|95.0|0.11|0.4||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.40|0.11|0.0008
91661085|NCT01854047|183217089|SUPERIORITY||LS Mean Difference|0.17||||0.0212|TWO_SIDED|95.0|0.03|0.32||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.32|0.03|0.0212
91661086|NCT01854047|183217089|SUPERIORITY||LS Mean Difference|0.08||||0.2774|TWO_SIDED|95.0|-0.07|0.23||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.23|-0.07|0.2774
91622801|NCT02659605|183138440|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.728|||||||Student's t-test|||||||0.728
91622802|NCT02659605|183138441|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.584|||||||Student's t-test|||||||0.584
91622803|NCT00475540|183138467|SUPERIORITY|Statistical analysis was performed using SAS 9.1 software. One patient did not receive the assigned mesh treatment because the surgeon felt there was inadequate vaginal caliber, so non mesh repair was performed. This subject was analyzed in the non mesh group for the 3-month and 1-year outcomes rather than intent-to-treat approach. This subject was lost to follow-up after 12 months and not included in the 3-year analysis.|||||<|0.05|||||||t-test, 2 sided|t-tests, Wilcoxon signed rank, Wilcoxon rank-sum tests continuous variables; X2 for categorical variables. Combined cure outcomes Fisher's exact test||Sample size primary outcome 1 year: 45 participants per arm, 20% difference success (70% no mesh and 90% mesh), alpha of .05 and 80% power, 15% loss to follow-up.||||<0.05
91622804|NCT04390568|183138484|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of the intravenous dose groups.|Slope|1.123|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|90.0|0.979|1.268|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.268|0.979|
91622805|NCT04390568|183138485|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the maximum measured concentration of the Spesolimap in plasma (Cmax) of the intravenous dose groups.|Slope|1.072|STANDARD_ERROR_OF_MEAN|0.065|||TWO_SIDED|90.0|0.961|1.183|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.183|0.961|
91622806|NCT03245723|183138488|OTHER|Descriptive statistics||||||0.38|||||||Wilcoxon Rank Sum test|||||||0.38
91622807|NCT03245723|183138489|OTHER|Descriptive statistics||||||0.12|||||||Wilcoxon Rank Sum test|||||||0.12
91622808|NCT03784027|183138492|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.001|TWO_SIDED|95.0|7.4|9.9|||Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||9.9|7.4|<0.001
91622809|NCT03784027|183138493|SUPERIORITY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-9.9|-7.1||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-7.1|-9.9|<0.001
91622810|NCT03784027|183138494|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-0.3|-0.5|<0.001
91622811|NCT03784027|183138495|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.9|-2.9|||Mixed Models Analysis|||||-2.9|-4.9|<0.001
91622812|NCT03784027|183138496|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-14.8|-9.8||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-9.8|-14.8|<0.001
91622813|NCT03784027|183138497|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.4|0.5||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear|||||0.5|-0.4|0.74
91622814|NCT03784027|183138498|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-7.6|-4.8|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-4.8|-7.6|
91661087|NCT01854047|183217090|SUPERIORITY||LS Mean Difference|0.16||||0.0002|TWO_SIDED|95.0|0.08|0.25||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.||0.25|0.08|0.0002
91661088|NCT01854047|183217090|SUPERIORITY||LS Mean Difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.011|0.28||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.28|0.011|<0.0001
91622815|NCT03784027|183138499|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values. Differences in percents are shown in percentage points.|Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.5|0.05|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.05|-1.5|
91622816|NCT03784027|183138500|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.1|0.1||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.1|-0.1|
91622817|NCT03784027|183138501|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.6|-0.6|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-0.6|-1.6|
91622818|NCT03784027|183138502|NON_INFERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.006|0.009|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.009|-0.006|
91622819|NCT03784027|183138503|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.75|TWO_SIDED|95.0|-0.02|0.03|||Regression, Linear|Based on a longitudinal model adjusting for baseline value and period as fixed effects. The model accounts for correlated data from the same subject.||||0.03|-0.02|0.75
91622820|NCT03784027|183138504|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.1|0.8|||||(For total daily insulin use) Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.8|-0.1|
91480969|NCT00478881|182834631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118||||0.4928||95.0|-0.22|0.456||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.456|-0.220|0.4928
91622821|NCT01512108|183138515|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.27||||0.0026||95.0|-0.44|-0.09|||ANOVA|||||-0.09|-0.44|0.0026
91622822|NCT01512108|183138516|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.3||||0.0458||95.0|-0.6|-0.01|||ANOVA|||||-0.01|-0.60|0.0458
91622823|NCT02373371|183138517|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||"Main analysis:~* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0"||||0.8460
91622824|NCT02373371|183138519|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
91622825|NCT02373371|183138520|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91622826|NCT04847141|183138523|SUPERIORITY||Difference in Percentage|-3.6||||0.5167|TWO_SIDED|95.0|-14.6|7.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 1 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||7.4|-14.6|0.5167
91622827|NCT04847141|183138523|SUPERIORITY||Difference in Percentage|1.2||||0.8197|TWO_SIDED|95.0|-9.6|12.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 2 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||12.0|-9.6|0.8197
91622828|NCT04847141|183138524|SUPERIORITY||Least squares (LS) Mean Difference|0.1||||0.5756|TWO_SIDED|95.0|-0.24|0.44|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.44|-0.24|0.5756
91661089|NCT01854047|183217090|SUPERIORITY||LS Mean Difference|0.12||||0.0048|TWO_SIDED|95.0|0.04|0.21||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.21|0.04|0.0048
91661090|NCT01854047|183217090|SUPERIORITY||LS Mean Difference|0.1||||0.0304|TWO_SIDED|95.0|0.01|0.18||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.18|0.01|0.0304
91661091|NCT02444715|183217112|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.96
91661092|NCT02444715|183217112|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.03
91661093|NCT02444715|183217113|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.53
91661094|NCT02444715|183217113|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.44
91661095|NCT02444715|183217114|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.76
91661096|NCT02444715|183217114|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
91661097|NCT02444715|183217115|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.39
91661098|NCT02444715|183217115|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
91661099|NCT02444715|183217116|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.92
91661100|NCT02444715|183217116|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.37
91661101|NCT02444715|183217117|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.78
91661102|NCT02444715|183217117|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.19
91713597|NCT00069823|183318644|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.7|TWO_SIDED|95.0|0.6|1.4||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.4|0.6|0.70
91622829|NCT04847141|183138524|SUPERIORITY||LS Mean Difference|-0.17||||0.3289|TWO_SIDED|95.0|-0.52|0.17|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.17|-0.52|0.3289
91622830|NCT04847141|183138524|SUPERIORITY||LS Mean Difference|0.11||||0.3418|TWO_SIDED|95.0|-0.12|0.34|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.34|-0.12|0.3418
91622831|NCT04847141|183138524|SUPERIORITY||LS Mean Difference|-0.11||||0.3688|TWO_SIDED|95.0|-0.34|0.13|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.13|-0.34|0.3688
91622832|NCT04847141|183138525|SUPERIORITY||Difference in Percentage|-1.3||||0.1506|TWO_SIDED|95.0|-4.7|1.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||1.2|-4.7|0.1506
91622833|NCT04847141|183138525|SUPERIORITY||Difference in Percentage|1.3||||0.1655|TWO_SIDED|95.0|-1.3|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||4.6|-1.3|0.1655
91622834|NCT04847141|183138525|SUPERIORITY||Difference in Percentage|-2.0||||0.2337|TWO_SIDED|95.0|-6.5|1.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||1.7|-6.5|0.2337
91622835|NCT04847141|183138525|SUPERIORITY||Difference in Percentage|-0.8||||0.7212|TWO_SIDED|95.0|-6.1|4.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||4.2|-6.1|0.7212
91622836|NCT04847141|183138525|SUPERIORITY||Difference in Percentage|-2.1||||0.3897|TWO_SIDED|95.0|-7.8|3.1||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||3.1|-7.8|0.3897
91622837|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|3.1||||0.5489|TWO_SIDED|95.0|-7.1|13.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 3||13.3|-7.1|0.5489
91622838|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|4.4||||0.392|TWO_SIDED|95.0|-5.8|14.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||14.7|-5.8|0.3920
91661103|NCT02444715|183217118|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.9
91661104|NCT02444715|183217118|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.43
91661105|NCT02444715|183217119|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.67
91661106|NCT02444715|183217119|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
91661107|NCT02444715|183217120|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.26
91661108|NCT02444715|183217120|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.07
91661109|NCT02444715|183217121|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.06
91661110|NCT02444715|183217121|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
91622839|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|1.7||||0.7632|TWO_SIDED|95.0|-9.5|12.9||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||12.9|-9.5|0.7632
91622840|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|7.9||||0.1702|TWO_SIDED|95.0|-3.6|19.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||19.2|-3.6|0.1702
91622841|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|-2.0||||0.7316|TWO_SIDED|95.0|-13.3|9.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||9.4|-13.3|0.7316
91622842|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|6.9||||0.2104|TWO_SIDED|95.0|-4.2|18.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||18.0|-4.2|0.2104
91622843|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|4.9||||0.2059|TWO_SIDED|95.0|-2.9|13.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 29||13.2|-2.9|0.2059
91622844|NCT04847141|183138526|SUPERIORITY||Difference in Percentage|1.9||||0.6463|TWO_SIDED|95.0|-6.5|10.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 29||10.3|-6.5|0.6463
91661111|NCT02444715|183217122|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.37
91661112|NCT02444715|183217122|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.34
91661113|NCT02444715|183217122|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.37
91661114|NCT02444715|183217122|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.59
91661115|NCT02444715|183217123|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.64
91661116|NCT02444715|183217123|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.14
91661117|NCT00819741|183217180|NON_INFERIORITY_OR_EQUIVALENCE|"If non-inferiority was shown (that was if H0 was rejected), then superiority of repaglinide and metformin combination therapy compared to repaglinide monotherapy would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.~The non-inferiority margin for HbA1c was set to 0.4%."|Estimated treatment difference, LS Mean|-0.302|STANDARD_ERROR_OF_MEAN|0.0096||||95.0|-0.491|-0.114|||ANCOVA|||"The non-inferiority margin for HbA1c was set to 0.4%.~The null hypothesis (H0) was:~H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4%~Against the alternative hypothesis (H1):~H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment \<0.4%"||-0.114|-0.491|
91713598|NCT00069823|183318645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.36|TWO_SIDED|95.0|-0.03|0.08||P values were calculated with the use of linear regression.|Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00 - (-0.02) = -0.03 (rounding)|The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group||0.08|-0.03|0.36
91622845|NCT04847141|183138527|SUPERIORITY|||||||0.9033|||||||Log Rank|||||||0.9033
91622846|NCT04847141|183138527|SUPERIORITY|||||||0.5456|||||||Log Rank|||||||0.5456
91622847|NCT04847141|183138528|SUPERIORITY||Difference in Percentage|0.79||||0.6311|TWO_SIDED|95.0|-2.9|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 1 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||4.6|-2.9|0.6311
91661118|NCT02222818|183217195|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025.|Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ -2% Alternative Hypothesis (Ha): μd \> -2% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods, and -2% is the non-inferiority margin selected based upon clinical judgment.||9.5|4.5|<0.0001
91622848|NCT04847141|183138528|SUPERIORITY||Difference in Percentage|2.6||||0.1441|TWO_SIDED|95.0|-1.2|7.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 2 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||7.3|-1.2|0.1441
91622849|NCT04847141|183138529|SUPERIORITY||LS Mean (LSM) Difference|0.02||||0.8555|TWO_SIDED|95.0|-0.23|0.27|||ANCOVA||95% CI for difference in LSM between 1 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.27|-0.23|0.8555
91622850|NCT04847141|183138529|SUPERIORITY||LS Mean Difference|0.03||||0.8108|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||95% CI for difference in LSM between 2 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.28|-0.22|0.8108
91622851|NCT04847141|183138531|SUPERIORITY||LS Mean Difference|0.03||||0.0692|TWO_SIDED|95.0|0.0|0.07||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.07|-0.00|0.0692
91622852|NCT04847141|183138531|SUPERIORITY||LS Mean Difference|0.01||||0.4956|TWO_SIDED|95.0|-0.02|0.05||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.05|-0.02|0.4956
91622853|NCT04847141|183138531|SUPERIORITY||LS Mean Difference|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.03|-0.13|0.2200
91661119|NCT02222818|183217196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ 0% Alternative Hypothesis (Ha): μd \> 0% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods.||9.5|4.5|<0.0001
91661120|NCT00834717|183217197|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.86||||||90.0|92.36|103.69|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.69|92.36|
91622854|NCT04847141|183138531|SUPERIORITY||LS Mean Difference|-0.07||||0.0906|TWO_SIDED|95.0|-0.14|0.01||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.01|-0.14|0.0906
91661121|NCT00834717|183217198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.57||||||90.0|82.8|103.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.48|82.80|
91713599|NCT00069823|183318646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3|TWO_SIDED|95.0|-0.03|0.09|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.09|-0.03|0.30
91713600|NCT00069823|183318647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|5.1||0.24|TWO_SIDED|95.0|-4.0|16.0|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||16.0|-4.0|0.24
91713601|NCT00069823|183318648|SUPERIORITY_OR_OTHER||Treatment Effect|-1.8||||0.04||95.0|-3.6|-0.1|||Regression, Linear|||||-0.1|-3.6|0.04
91713602|NCT00069823|183318649|SUPERIORITY_OR_OTHER||Treatment Effect|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.0|0.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.2|0.0|0.11
91622855|NCT04847141|183138531|SUPERIORITY||LS Mean Difference|-0.04||||0.0439|TWO_SIDED|95.0|-0.07|0.0||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||-0.00|-0.07|0.0439
91713603|NCT00069823|183318650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.11|TWO_SIDED|95.0|-0.05|-0.02|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||-0.02|-0.05|0.11
91622856|NCT04847141|183138531|SUPERIORITY||LS Mean Difference|-0.01||||0.4128|TWO_SIDED|95.0|-0.05|0.02||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.02|-0.05|0.4128
91622857|NCT04847141|183138533|SUPERIORITY||LS Mean Difference|-0.01||||0.9713|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.27|-0.28|0.9713
91713604|NCT00069823|183318651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|-0.2|0.1|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.1|-0.2|0.33
91480970|NCT00478881|182834632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823||||0.3248||95.0|-2.476|0.829||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.829|-2.476|0.3248
91480971|NCT00478881|182834633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.095||||0.5312||95.0|-4.533|2.342||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA|||ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||2.342|-4.533|0.5312
91480972|NCT05803603|182834658|SUPERIORITY||Odds Ratio (OR)|2.0||||0.125|TWO_SIDED|95.0|0.37|10.92|||McNemar|||We recruited 8 homeless individuals and followed them for 12 months. 4 individuals (50%) were housed at 6 months and 3 (37.5) were housed at 12 months.|See results above|10.92|.37|.125
91480973|NCT03977454|182834693|SUPERIORITY||Mean Difference (Net)|1.2||||0.69|TWO_SIDED||||||t-test, 2 sided|||The primary endpoint was a comparison between groups at 24 hours.||||0.69
91622858|NCT04847141|183138533|SUPERIORITY||LS Mean Difference|0.07||||0.5985|TWO_SIDED|95.0|-0.2|0.35||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.35|-0.20|0.5985
91480974|NCT03977454|182834694|SUPERIORITY||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 days post operation.||||0.92
91622859|NCT04847141|183138533|SUPERIORITY||LS Mean Difference|0.01||||0.9209|TWO_SIDED|95.0|-0.25|0.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.28|-0.25|0.9209
91622860|NCT04847141|183138533|SUPERIORITY||LS Mean Difference|-0.01||||0.9181|TWO_SIDED|95.0|-0.28|0.25||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.25|-0.28|0.9181
91622861|NCT04847141|183138533|SUPERIORITY||LS Mean Difference|0.15||||0.2443|TWO_SIDED|95.0|-0.11|0.41||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.41|-0.11|0.2443
91622862|NCT04847141|183138533|SUPERIORITY||LS Mean Difference|0.13||||0.3233|TWO_SIDED|95.0|-0.13|0.39||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.39|-0.13|0.3233
91661122|NCT00834717|183217199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.95||||||90.0|83.11|103.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.97|83.11|
91661123|NCT00795821|183217212|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
91661124|NCT00795821|183217214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
91661125|NCT00795821|183217216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
91713605|NCT00069823|183318652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.16|TWO_SIDED|95.0|-2.0|0.4|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.4|-2.0|0.16
91480975|NCT03977454|182834695|SUPERIORITY||Mean Difference (Net)|0.5||||0.91|TWO_SIDED||||||t-test, 2 sided|||||||0.91
91480976|NCT03977454|182834697|SUPERIORITY||Mean Difference (Net)|0.0||||0.85|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 weeks.||||0.85
91480977|NCT00930982|182834698|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.368|STANDARD_ERROR_OF_MEAN|2.674|<|0.001||||||p-value should be \< 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.|ANCOVA|Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.|Least square mean Ciprofloxacin minus placebo|"Ho: CFU(EOT\|Cipro) - CFU(baseline\|Cipro) \> CFU(EOT\|Placebo) - CFU(baseline\|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g"||||< 0.001
91622863|NCT04847141|183138534|SUPERIORITY||Difference in Percentage|3.0||||0.4676|TWO_SIDED|95.0|-5.3|11.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||11.5|-5.3|0.4676
91661126|NCT00795821|183217218|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
91661127|NCT00795821|183217220|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.007
91661128|NCT00795821|183217222|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.056
91622864|NCT04847141|183138534|SUPERIORITY||Difference in Percentage|4.9||||0.2507|TWO_SIDED|95.0|-3.6|13.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||13.4|-3.6|0.2507
91622865|NCT04847141|183138535|SUPERIORITY||Difference in Percentage|0.1||||0.9744|TWO_SIDED|95.0|-3.8|4.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||4.0|-3.8|0.9744
91622866|NCT04847141|183138535|SUPERIORITY||Difference in Percentage|2.7||||0.1878|TWO_SIDED|95.0|-1.6|7.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||7.5|-1.6|0.1878
91622867|NCT04847141|183138536|SUPERIORITY||LS Mean Difference|0.01||||0.9485|TWO_SIDED|95.0|-0.38|0.4|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.40|-0.38|0.9485
91622868|NCT04847141|183138536|SUPERIORITY||LS Mean Difference|0.14||||0.4734|TWO_SIDED|95.0|-0.25|0.54|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.54|-0.25|0.4734
91622869|NCT04847141|183138537|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
91622870|NCT04847141|183138537|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
91622871|NCT04847141|183138538|SUPERIORITY||LS Mean Difference|0.03||||0.578|TWO_SIDED|95.0|-0.07|0.12|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.12|-0.07|0.5780
91661129|NCT00795821|183217224|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
91622872|NCT04847141|183138538|SUPERIORITY||LS Mean Difference|0.01||||0.9065|TWO_SIDED|95.0|-0.09|0.1|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.10|-0.09|0.9065
91622873|NCT04847141|183138542|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
91622874|NCT04847141|183138542|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
91622875|NCT01357980|183138559|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.54||||0.11|TWO_SIDED|95.0|-3.47|0.39||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.39|-3.47|0.11
91622876|NCT01357980|183138559|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.61||||0.07|TWO_SIDED|95.0|-1.27|0.05||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.05|-1.27|0.07
91622877|NCT01357980|183138560|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|219.5|||<|0.01|TWO_SIDED|95.0|69.6|369.5|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||369.5|69.6|<0.01
91622878|NCT01357980|183138560|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|224.1|||<|0.01|TWO_SIDED|95.0|140.9|307.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||307.4|140.9|<0.01
91661130|NCT00795821|183217226|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
91661131|NCT00795821|183217228|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.003
91661132|NCT00795821|183217230|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.009
91661133|NCT00795821|183217232|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Severity of Overall Fatigue|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.008
91480978|NCT00518973|182834713|SUPERIORITY|||||||0.15||||||t = 2.8|t-test, 2 sided|Hours occupied by preoccupations.||||||.15
91622879|NCT01357980|183138560|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|117.0||||0.09||95.0|-20.0|254.0|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||254.0|-20.0|0.09
91622880|NCT01357980|183138560|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|223.7|||<|0.01|TWO_SIDED|95.0|94.3|353.1|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||353.1|94.3|<0.01
91622881|NCT01357980|183138560|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|138.5||||0.01|TWO_SIDED|95.0|34.7|242.2|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||242.2|34.7|0.01
91622882|NCT01357980|183138560|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|186.3|||<|0.01|TWO_SIDED|95.0|53.2|319.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||319.4|53.2|<0.01
91661134|NCT00795821|183217232|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Fatigue Interference with Daily Activities|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.024
91661135|NCT00795821|183217234|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for participants reporting use of primary doctor|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.261
91480979|NCT00518973|182834713|SUPERIORITY|||||||0.4||||||t = .56|t-test, 2 sided|Hours of rituals||||||.40
91622883|NCT01357980|183138561|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-23.8||||0.25|TWO_SIDED|95.0|-66.6|18.9|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||18.9|-66.6|0.25
91622884|NCT01357980|183138561|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-67.1|||<|0.01|TWO_SIDED|95.0|-112.9|-21.2|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-21.2|-112.9|<0.01
91661136|NCT00795821|183217234|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||P-value for participants reporting use of specialist|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.868
91661137|NCT00795821|183217234|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||P-value for participants reporting other diagnostic tests|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.495
91661138|NCT00795821|183217234|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value for participants reporting prescribed medication|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.189
91661139|NCT00795821|183217236|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for suicidal ideation|Fisher Exact|||||||0.737
91661140|NCT00795821|183217238|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for change in supine systolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
91480980|NCT00518973|182834714|SUPERIORITY|||||||0.72||||||t = .13|t-test, 2 sided|||||||.72
91661141|NCT00795821|183217238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in supine diastolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
91661142|NCT00795821|183217240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
91661143|NCT01285713|183217243|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|95.0|||||Paired t-test|||||||0.0003
91661144|NCT01415232|183217250|NON_INFERIORITY_OR_EQUIVALENCE|Balki et al found a Pearson's correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled.|correlation coefficient|0.91|||<|0.05|TWO_SIDED|95.0|0.87|0.93|||longitudinal correlation coefficient|||Pearson's correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.||0.93|0.87|< 0.05
91480981|NCT00518973|182834715|SUPERIORITY|||||||0.48||||||t = .52|t-test, 2 sided|Reporting for Trait||||||.48
91480982|NCT00518973|182834715|SUPERIORITY|||||||0.77||||||t = .09|t-test, 2 sided|Reporting for State||||||.77
91480983|NCT00518973|182834716|SUPERIORITY|||||||0.83||||||t = .05|t-test, 2 sided|||||||.83
91480984|NCT00518973|182834717|SUPERIORITY|||||||0.4||||||t = .78|t-test, 2 sided|Positive Scale||||||.40
91480985|NCT00518973|182834717|SUPERIORITY|||||||0.11||||||t=3.0|t-test, 2 sided|Negative Scale||||||.11
91480986|NCT00518973|182834717|SUPERIORITY|||||||0.9||||||t = .02|t-test, 2 sided|General Scale||||||.90
91480987|NCT01923168|182834757|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.3||||0.282|TWO_SIDED|80.0|-4.5|1.7|||Posterior mean diff. & credible interval|||||1.7|-4.5|0.282
91622885|NCT01357980|183138561|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-35.1||||0.03|TWO_SIDED|95.0|-65.6|-4.6|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-4.6|-65.6|0.03
91622886|NCT01357980|183138561|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-51.0||||0.01|TWO_SIDED|95.0|-89.5|-12.4|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-12.4|-89.5|0.01
91622887|NCT01357980|183138561|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-32.3|||<|0.01|TWO_SIDED|95.0|-53.7|-11.0|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-11.0|-53.7|<0.01
91661145|NCT01415232|183217250|NON_INFERIORITY_OR_EQUIVALENCE|correlation coefficient|transverse plane correlation coefficient|0.9|||>|0.85|TWO_SIDED|95.0|0.87|0.93|||transverse plane correlation coefficient|||Transverse plane correlation coefficient||0.93|0.87|>0.85
91480988|NCT01923168|182834758|OTHER|Bayesian double criteria|Mean Difference (Final Values)|1.1||||0.697|TWO_SIDED|80.0|-1.9|4.2|||Posterior mean difference|Posterior mean difference||||4.2|-1.9|0.697
91622888|NCT01357980|183138561|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-45.3|||<|0.01|TWO_SIDED|95.0|-76.6|-14.1|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-14.1|-76.6|<0.01
91622889|NCT01357980|183138562|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.7||||0.05||95.0|||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
91622890|NCT01357980|183138562|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
91622891|NCT01357980|183138563|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3||||0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.01
91622892|NCT01357980|183138563|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.8|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
91622893|NCT01357980|183138564|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.9||||0.05|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
91622894|NCT01357980|183138564|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.1|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
91622895|NCT01357980|183138565|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.13|||<|0.01|TWO_SIDED|95.0|-1.91|-0.35|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.35|-1.91|<0.01
91622896|NCT01357980|183138565|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.18||||0.7|TWO_SIDED|95.0|-1.26|0.9|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.90|-1.26|0.7
91622897|NCT01357980|183138565|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.52||||0.3|TWO_SIDED|95.0|-1.56|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.56|0.3
91480989|NCT01923168|182834759|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.4||||0.435|TWO_SIDED|80.0|-12.5|9.7|||Posterior mean diff. & credible interval|||||9.7|-12.5|0.435
91622898|NCT01357980|183138565|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.48||||0.3|TWO_SIDED|95.0|-1.47|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.47|0.3
91480990|NCT01923168|182834760|OTHER|Bayesian double criteria|Mean Difference (Final Values)|2.4||||0.611|TWO_SIDED|80.0|-8.4|13.2|||Posterior mean diff. & credible interval|||||13.2|-8.4|0.611
91480991|NCT00773838|182834803|OTHER|||||||0.419|||||||Exact Test for Binomial Parameter|||||||0.419
91622899|NCT01357980|183138565|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.38|||<|0.01|TWO_SIDED|95.0|-2.02|-0.73|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.73|-2.02|<0.01
91622900|NCT01357980|183138565|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.4||||0.4|TWO_SIDED|95.0|-1.35|0.55|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.55|-1.35|0.4
91622901|NCT04507776|183138569|OTHER|||||||0.75|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.75
91622902|NCT04507776|183138569|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
91622903|NCT04507776|183138569|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||<0.05
91622904|NCT04507776|183138569|OTHER|||||||0.43|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.43
91622905|NCT04507776|183138570|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
91622906|NCT04507776|183138570|OTHER|||||||0.247|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.247
91622907|NCT04507776|183138571|OTHER|||||||0.21|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.21
91622908|NCT04507776|183138571|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
91622909|NCT04507776|183138571|OTHER|||||||0.62|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||0.62
91622910|NCT04507776|183138571|OTHER|||||||0.18|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.18
91622911|NCT04507776|183138572|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
91622912|NCT04507776|183138572|OTHER|||||||0.003|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.003
91622913|NCT03532776|183138618|EQUIVALENCE|BE limits: -20.0% to 20.0%|Equivalence ratio|0.98|||||TWO_SIDED|90.0|-12.0|7.0||||||||7|-12|
91622914|NCT00868166|183138625|SUPERIORITY|||||||0.71|||||||Stratified Log-Rank Test|||||||0.71
91622915|NCT00868166|183138626|SUPERIORITY|||||||0.83|||||||Stratified Log-Rank Test|||||||0.83
91622916|NCT00868166|183138626|SUPERIORITY|||||||0.73|||||||Non-stratified Log-Rank Test|||||||0.73
91622917|NCT00868166|183138628|SUPERIORITY|||||||0.21|||||||Stratified Log-Rank Test|||||||0.21
91622918|NCT00868166|183138628|SUPERIORITY|||||||0.2|||||||Non-stratified Log-Rank Test|||||||0.20
91622919|NCT00868166|183138630|SUPERIORITY|||||||0.56|||||||Stratified Log-Rank Test|||||||0.56
91622920|NCT01779648|183138640|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Chi-squared|||||||0.785
91622921|NCT01779648|183138641|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.195
91622922|NCT01779648|183138642|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.722
91661146|NCT01415232|183217250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.64|STANDARD_DEVIATION|1.0|>|0.05|TWO_SIDED|95.0|6.5|6.8|||t-test, 2 sided|||Clinical epidural needle depth||6.8|6.5|>0.05
91480992|NCT02522871|182834820|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.132|||<|0.0001|ONE_SIDED|95.0||-0.049|||one-sided Farrington and Manning|||||-0.049||<0.0001
91622923|NCT01779648|183138643|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.158
91622924|NCT01779648|183138644|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.301
91622925|NCT01779648|183138645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline TVF (total volume flow) are controlled as fixed-effects parameters.||||||<0.001
91622926|NCT01779648|183138646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PVF (peak volume flow) are controlled as fixed-effects parameters.||||||<0.001
91622927|NCT01779648|183138647|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PV (peak velocity)are controlled as fixed-effects parameters.||||||0.929
91622928|NCT01779648|183138649|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline peak volume flow are controlled as fixed-effects parameters.||||||0.008
91622929|NCT01779648|183138650|SUPERIORITY_OR_OTHER|||||||0.132||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline total volume flow are controlled as fixed-effects parameters.||||||0.132
91622930|NCT01797445|183138652|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.1||||0.13|TWO_SIDED|95.002|-1.0|7.1|||Cochran-Mantel-Haenszel|P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.||7.1|-1.0|0.13
91622931|NCT04190186|183138697|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.594|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.594
91622932|NCT01397448|183138728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.31|||Log Rank|||||0.31|0.04|<0.001
91480993|NCT02522871|182834820|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.145|||<|0.0001|ONE_SIDED|95.0||-0.062|||one-sided Farrington and Manning|||||-0.062||<0.0001
91480994|NCT02522871|182834821|NON_INFERIORITY|non-inferiority margin of 1.0|Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.084|0.025|||t-test, 1 sided|||||0.025|-0.084|<0.0001
91480995|NCT02522871|182834822|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
91480996|NCT02522871|182834822|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
91480997|NCT02522871|182834823|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
91480998|NCT02522871|182834823|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
91480999|NCT02398227|182834826|SUPERIORITY|||||||0.968|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.968
91481000|NCT02398227|182834827|SUPERIORITY|||||||0.56|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.560
91622933|NCT01397448|183138728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.23|||Log Rank|||||0.23|0.01|<0.001
91622934|NCT02466412|183138732|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|63.9326|||||TWO_SIDED|95.0|49.6045|82.3991|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.||82.3991|49.6045|
91622935|NCT02466412|183138733|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|60.0052|||||TWO_SIDED|95.0|44.9517|80.0997|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.||80.0997|44.9517|
91622936|NCT02180217|183138739|OTHER||Odds Ratio (OR)|13.71|||<|0.001|TWO_SIDED|95.0|3.73|53.44|||Cochran-Mantel-Haenszel|||||53.44|3.73|<.001
91622937|NCT03483116|183138767|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%.|Response rate|0.1553|||||TWO_SIDED|95.0|0.039|0.272||||||||0.272|0.039|
91622938|NCT03483116|183138767|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Response rate|0.001|||||TWO_SIDED|95.0|-0.115|0.117||||||||0.117|-0.115|
91622939|NCT03483116|183138767|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Difference Response rate|0.1543|||||TWO_SIDED|95.0|0.038|0.27||||||Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%||0.270|0.038|
91661147|NCT01415232|183217250|SUPERIORITY_OR_OTHER||Formula calculation|6.54|STANDARD_DEVIATION|0.68|>|0.05|TWO_SIDED|95.0|6.44|6.65|||Formula calculation||Estimated epidural depth equation depth (cm)|Estimated epidural depth equation depth (cm)||6.65|6.44|>0.05
91661148|NCT03570749|183217256|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|2.75|12.02|||Regression, Logistic|||||12.02|2.75|<0.001
91661149|NCT03570749|183217256|SUPERIORITY||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|5.89|23.62|||Regression, Logistic|||||23.62|5.89|<0.001
91661150|NCT03570749|183217257|SUPERIORITY||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.81|8.51|||Regression, Logistic|||||8.51|1.81|<0.001
91661151|NCT03570749|183217257|SUPERIORITY||Odds Ratio (OR)|10.26|||<|0.001|TWO_SIDED|95.0|5.05|20.87|||Regression, Logistic|||||20.87|5.05|<0.001
91622940|NCT01181102|183138777|NON_INFERIORITY_OR_EQUIVALENCE|"(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.~(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)"|Cox Proportional Hazard|-6.5|||<|0.001|TWO_SIDED|95.0|-11.5|-1.6||non-inferiority:P \< 0.001 superiority:P = 0.010|non-inferiority:Z test. superiority:χ2 t|||The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).||-1.6|-11.5|<0.001
91622941|NCT01181102|183138778|SUPERIORITY_OR_OTHER||χ2 test|2.5|||||TWO_SIDED|95.0|-0.8|5.9||||||||5.9|-0.8|
91622942|NCT01315002|183138779|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.||||<0.05
91622943|NCT00239837|183138789|SUPERIORITY_OR_OTHER_LEGACY||Wald χ2|7.14||||0.008|TWO_SIDED||||||Regression, Logistic|Data analyzed using repeated logistic regression model (generalized estimating equations). Domain X EV Level X Group interaction tested.|We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).|||||.008
91622944|NCT00929734|183138827|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||ANCOVA|||||||0.292
91622945|NCT00929734|183138828|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||ANCOVA|||||||0.462
91622946|NCT00929734|183138829|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)|ANCOVA|||||||0.017
91622947|NCT00929734|183138830|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||ANCOVA with natural logarithm of interleukin 6 (ln IL6)|ANCOVA|||||||0.028
91481001|NCT03149848|182834856|OTHER||Ratio|0.786|||||TWO_SIDED|90.0|0.743|0.831||||||||0.831|0.743|
91622948|NCT00980980|183138831|SUPERIORITY_OR_OTHER|||||||0.01|||||||Proportional-hazards models|Proportional-hazards models with shared frailties accounted for clustering within hospitals.||||||0.01
91622949|NCT00094887|183138859|OTHER||||||=|0.8085|||||||Wilcoxon (Mann-Whitney)|||||||= 0.8085
91661152|NCT03570749|183217258|SUPERIORITY||Odds Ratio (OR)|5.58||||0.001|TWO_SIDED|95.0|1.97|15.83|||Regression, Logistic|||||15.83|1.97|0.001
91661153|NCT03570749|183217258|SUPERIORITY||Odds Ratio (OR)|14.34|||<|0.001|TWO_SIDED|95.0|5.3|38.83|||Regression, Logistic|||||38.83|5.30|<0.001
91622950|NCT04093258|183138872|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.33|6.85|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test/Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||6.85|0.33|
91622951|NCT04093258|183138873|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.1|1.19|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test over Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||1.19|0.10|
91481002|NCT03149848|182834857|OTHER||Ratio|0.825|||||TWO_SIDED|90.0|0.761|0.895||||||||0.895|0.761|
91481003|NCT03149848|182834858|OTHER||Ratio|0.738|||||TWO_SIDED|90.0|0.702|0.776||||||||0.776|0.702|
91481004|NCT03149848|182834861|OTHER||Ratio|1.272|||||TWO_SIDED|90.0|1.204|1.345||||||||1.345|1.204|
91481005|NCT01892722|182834930|SUPERIORITY||||||<|0.001|||||||Negative binomial regression model|||||||<0.001
91622952|NCT04093258|183138874|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least square mean difference|-5.98|STANDARD_ERROR_OF_MEAN|3.202|||TWO_SIDED|95.0|-12.48|0.52|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|||0.52|-12.48|
91622953|NCT00643604|183138894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||0.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.69
91622954|NCT00643604|183138895|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91622955|NCT00643604|183138896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
91622956|NCT00643604|183138897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p value for Symptom Score|Wilcoxon signed rank test|||Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
91661154|NCT03570749|183217259|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|2.72|39.3|||Regression, Logistic|||||39.30|2.72|<0.001
91661155|NCT03570749|183217259|SUPERIORITY||Odds Ratio (OR)|18.47|||<|0.001|TWO_SIDED|95.0|5.04|67.68|||Regression, Logistic|||||67.68|5.04|<0.001
91661156|NCT03570749|183217260|SUPERIORITY||Odds Ratio (OR)|6.6|||<|0.001|TWO_SIDED|95.0|2.34|18.62|||Regression, Logistic|||||18.62|2.34|<0.001
91622957|NCT00643604|183138897|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||p value for Activity Score.|Wilcoxon signed rank test|||Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91622958|NCT00643604|183138897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Wilcoxon signed-rank test|||Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
91622959|NCT00643604|183138897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||"Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.~Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values."||||0.13
91622960|NCT00643604|183138898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
91622961|NCT00643604|183138898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
91622962|NCT00643604|183138898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Wilcoxon signed-rank test|||Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
91622963|NCT00643604|183138898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
91661157|NCT03570749|183217260|SUPERIORITY||Odds Ratio (OR)|13.58|||<|0.001|TWO_SIDED|95.0|5.01|36.81|||Regression, Logistic|||||36.81|5.01|<0.001
91661158|NCT03570749|183217261|SUPERIORITY||Odds Ratio (OR)|4.63||||0.012|TWO_SIDED|95.0|1.41|15.27|||Regression, Logistic|||||15.27|1.41|0.012
91661159|NCT03570749|183217261|SUPERIORITY||Odds Ratio (OR)|14.42|||<|0.001|TWO_SIDED|95.0|4.73|43.93|||Regression, Logistic|||||43.93|4.73|<0.001
91661160|NCT03570749|183217262|SUPERIORITY||Mean Difference (Final Values)|-23.1|STANDARD_ERROR_OF_MEAN|3.806|<|0.001|TWO_SIDED|95.0|-30.57|-15.63|||ANCOVA|||||-15.63|-30.57|<0.001
91661161|NCT03570749|183217262|SUPERIORITY||Mean Difference (Final Values)|-37.65|STANDARD_ERROR_OF_MEAN|3.447|<|0.001|TWO_SIDED|95.0|-44.24|-30.89|||ANCOVA|||||-30.89|-44.24|<0.001
91661162|NCT03570749|183217263|SUPERIORITY||Odds Ratio (OR)|2.31||||0.047|TWO_SIDED|95.0|1.01|5.29|||Regression, Logistic|||||5.29|1.01|0.047
91661163|NCT03570749|183217263|SUPERIORITY||Odds Ratio (OR)|6.03|||<|0.001|TWO_SIDED|95.0|2.91|12.51|||Regression, Logistic|||||12.51|2.91|<0.001
91622964|NCT00643604|183138899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon signed-rank test|||Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
91622965|NCT00643604|183138899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Wilcoxon signed-rank test|||Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.06
91622966|NCT00643604|183138899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Wilcoxon signed-rank test|||Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.63
91622967|NCT00643604|183138899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
91622968|NCT00643604|183138899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
91661164|NCT03570749|183217265|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.288||0.005|TWO_SIDED|95.0|-1.38|-0.25|||ANCOVA|||||-0.25|-1.38|0.005
91661165|NCT03570749|183217265|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.261||0.04|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||||-0.02|-1.05|0.040
91661166|NCT03570749|183217266|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.259||0.107|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||||0.09|-0.93|0.107
91661167|NCT03570749|183217266|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.234||0.174|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||||0.14|-0.78|0.174
91661168|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.05|0.171|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~The primary endpoint was analyzed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects and baseline as a covariate. The confidence intervals (CIs) and the p-values of the comparisons between each dose of CHF 1531 pMDI and Placebo at Day 14 were adjusted for multiplicity, based on the parametric simulation method of Edwards and Berry."||0.171|0.050|<0.001
91661169|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.095|0.22|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.220|0.095|<0.001
91661170|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.072|0.194|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.194|0.072|<0.001
91622969|NCT00643604|183138900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.5
91622970|NCT00643604|183138901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon sign-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
91622971|NCT00643604|183138902|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91622972|NCT00643604|183138903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
91622973|NCT00643604|183138904|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91622974|NCT00643604|183138905|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91622975|NCT00643604|183138906|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
91622976|NCT00804843|183138955|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.27||||0.811|TWO_SIDED|90.0|-0.24|0.78|||ANOVA|||||0.78|-0.24|0.811
91622977|NCT00804843|183138956|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.64||||0.898|TWO_SIDED|90.0|-1.09|8.36|||ANOVA|||||8.36|-1.09|0.898
91661171|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.167|||<|0.001|TWO_SIDED|95.0|0.109|0.225|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.225|0.109|<0.001
91661172|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.144|||<|0.001|TWO_SIDED|95.0|0.098|0.19|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.190|0.098|<0.001
91661173|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.059|TWO_SIDED|95.0|-0.002|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.095|-0.002|0.059
91713606|NCT00069823|183318653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED|95.0|-1.1|2.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||2.2|-1.1|0.56
91622978|NCT05263921|183138986|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|107.35|||||TWO_SIDED|90.0|99.66|115.64||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||115.64|99.66|
91622979|NCT05263921|183138986|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.73|||||TWO_SIDED|90.0|112.09|130.03||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.03|112.09|
91622980|NCT05263921|183138986|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|125.04|||||TWO_SIDED|90.0|116.08|134.69||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||134.69|116.08|
91622981|NCT05263921|183138987|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.8|||||TWO_SIDED|90.0|101.06|117.14||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||117.14|101.06|
91622982|NCT05263921|183138987|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.95|||||TWO_SIDED|90.0|112.36|130.2||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.20|112.36|
91622983|NCT05263921|183138987|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|127.39|||||TWO_SIDED|90.0|118.32|137.15||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||137.15|118.32|
91622984|NCT05263921|183138988|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|115.1|||||TWO_SIDED|90.0|104.03|127.34||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||127.34|104.03|
91622985|NCT05263921|183138988|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|145.6|||||TWO_SIDED|90.0|131.68|160.99||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||160.99|131.68|
91622986|NCT05263921|183138988|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|161.48|||||TWO_SIDED|90.0|145.95|178.66||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||178.66|145.95|
91661174|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.361|TWO_SIDED|95.0|-0.026|0.07|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.070|-0.026|0.361
91713607|NCT00069823|183318654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.76|TWO_SIDED|95.0|-0.05|0.07|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.07|-0.05|0.76
91713608|NCT00069823|183318655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.3|-0.8|0.39
91713609|NCT01801111|183318658|OTHER|||||||0.0005|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the objective response rate (ORR) is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0005
91713610|NCT01801111|183318659|OTHER|||||||0.0599|TWO_SIDED||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0599
91481006|NCT00076024|182834954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.237||||0.156|TWO_SIDED|95.0|0.819|1.867|||Log Rank|One-sided log-rank test at alpha = 0.1 significance level was used.||P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.||1.867|0.819|0.156
91622987|NCT05263921|183138989|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.85|||||TWO_SIDED|90.0|95.38|128.82||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.82|95.38|
91622988|NCT05263921|183138989|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|106.55|||||TWO_SIDED|90.0|91.76|123.73||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||123.73|91.76|
91622989|NCT05263921|183138989|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.74|||||TWO_SIDED|90.0|92.7|125.21||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.21|92.70|
91622990|NCT05263921|183138990|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.19|||||TWO_SIDED|90.0|94.51|128.47||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.47|94.51|
91622991|NCT05263921|183138990|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.17|||||TWO_SIDED|90.0|92.0|124.86||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||124.86|92.00|
91622992|NCT05263921|183138990|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.83|||||TWO_SIDED|90.0|92.48|125.72||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.72|92.48|
91622993|NCT05263921|183138991|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.72|||||TWO_SIDED|90.0|89.32|132.32||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||132.32|89.32|
91622994|NCT05263921|183138991|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.44|||||TWO_SIDED|90.0|90.05|133.0||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||133.00|90.05|
91622995|NCT05263921|183138991|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|117.3|||||TWO_SIDED|90.0|96.37|142.77||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||142.77|96.37|
91622996|NCT02678312|183139045|SUPERIORITY||Cox Proportional Hazard|1.0655||||0.7958|TWO_SIDED|95.0|0.6589|1.7232||The adjusted hazard ratio and the p-values are based on a Cox proportional hazard model, stratified by modified age group with treatment and NYHA/ROSS class group included as factor.|Cox Proportional Hazard|||||1.7232|0.6589|0.7958
91622997|NCT00640146|183139072|OTHER|||||||0.0213|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 2 hours of the first dose of study drug, testing MNTX against placebo.||||0.0213
91622998|NCT00640146|183139073|OTHER|||||||0.0463|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 4 hours of the first dose of study drug, testing MNTX against placebo.||||0.0463
91622999|NCT02455388|183139087|EQUIVALENCE|No equivalence margin set.|||||<|0.001|||||||Intraclass correlation coefficient|||||||<0.001
91623000|NCT02455388|183139088|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91623001|NCT02455388|183139089|OTHER||Odds Ratio (OR)|1.7|||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<0.01
91713611|NCT01801111|183318661|OTHER|||||||0.0001|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0001
91623002|NCT02119026|183139134|SUPERIORITY|||||||0.967|||||||Mantel Haenszel|||||||0.967
91623003|NCT02119026|183139135|SUPERIORITY|||||||0.474|||||||Mantel Haenszel|||||||0.474
91623004|NCT02119026|183139136|SUPERIORITY|||||||0.464|||||||Mantel Haenszel|||||||0.464
91623005|NCT02119026|183139137|SUPERIORITY|||||||0.854|||||||Fisher Exact|||||||0.854
91623006|NCT02119026|183139138|SUPERIORITY|||||||0.728|||||||Mantel Haenszel|||||||0.728
91623007|NCT02119026|183139139|SUPERIORITY|||||||0.668|||||||Mantel Haenszel|||||||0.668
91623008|NCT02119026|183139140|SUPERIORITY|||||||0.618|||||||Mantel Haenszel|||||||0.618
91623009|NCT02119026|183139141|SUPERIORITY|||||||0.792||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.792
91623010|NCT02119026|183139142|SUPERIORITY|||||||0.371||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.371
91623011|NCT03783442|183139166|SUPERIORITY||Stratified Hazard Ratio|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Stratified Log-rank Test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.80|0.54|<0.0001
91623012|NCT03783442|183139167|SUPERIORITY||Stratified Hazard Ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.75|0.52|<0.0001
91623013|NCT03783442|183139168|SUPERIORITY||Odds Ratio (OR)|2.38|||<|0.0001|TWO_SIDED|95.0|1.73|3.27|||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|||3.27|1.73|<0.0001
91623014|NCT03783442|183139169|SUPERIORITY||Stratified Hazard Ratio|0.62||||0.0029|TWO_SIDED|95.0|0.44|0.87|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.87|0.44|0.0029
91623015|NCT03783442|183139171|SUPERIORITY||Least Squares (LS) Mean Difference|4.4||||0.1372|TWO_SIDED|95.0|-1.4|10.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Dysphagia Score at Cycle 6||10.3|-1.4|0.1372
91623016|NCT03783442|183139171|SUPERIORITY||LS Mean Difference|0.6||||0.713|TWO_SIDED|95.0|-2.5|3.7|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Eating Score at Cycle 6||3.7|-2.5|0.7130
91623017|NCT03783442|183139171|SUPERIORITY||LS Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Reflux Score at Cycle 6||1.3|-4.1|0.3001
91623018|NCT03783442|183139171|OTHER||LS Mean Difference|-1.9|||||TWO_SIDED|95.0|-3.9|0.2|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Pain Score at Cycle 6||0.2|-3.9|
91623019|NCT03783442|183139171|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-2.1|1.4|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Index Score at Cycle 6||1.4|-2.1|
91623020|NCT03783442|183139172|OTHER||LS Mean Difference|3.3|||||TWO_SIDED|95.0|0.4|6.2|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||6.2|0.4|
91623021|NCT03783442|183139172|OTHER||LS Mean Difference|2.6|||||TWO_SIDED|95.0|0.0|5.1|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||5.1|0.0|
91623022|NCT03783442|183139173|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-4.7|1.9|||||Based on a mixed effect model analysis with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|||1.9|-4.7|
91623023|NCT02016898|183139176|OTHER||Risk Ratio (RR)|0.93||||0.7|TWO_SIDED|95.0|0.67|1.29|||Chi-squared|||||1.29|0.67|0.7
91623024|NCT02016898|183139177|OTHER||Median Difference (Final Values)|0.2|STANDARD_DEVIATION|2.01||0.539|TWO_SIDED||||||t-test, 1 sided|||||||0.539
91661175|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.016|TWO_SIDED|95.0|0.011|0.102|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.102|0.011|0.016
91661176|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|-0.025||||0.34|TWO_SIDED|95.0|-0.075|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.075|0.340
91661177|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.69|TWO_SIDED|95.0|-0.038|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.038|0.690
91661178|NCT03086460|183217289|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.155|TWO_SIDED|95.0|-0.013|0.082|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.082|-0.013|0.155
91623025|NCT02505542|183139188|SUPERIORITY||Odds Ratio (OR)|18.822|||<|0.001|TWO_SIDED|95.0|9.605|38.864||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||38.864|9.605|<0.001
91623026|NCT02505542|183139188|SUPERIORITY||Odds Ratio (OR)|14.069|||<|0.001|TWO_SIDED|95.0|7.395|27.955||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||27.955|7.395|<0.001
91623027|NCT02505542|183139192|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
91623028|NCT02505542|183139192|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
91623029|NCT02505542|183139194|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.001|TWO_SIDED|95.0|8.95|35.961|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||35.961|8.950|<0.001
91481007|NCT00076024|182834955|SUPERIORITY_OR_OTHER||Difference in response rates|17.4||||0.038|TWO_SIDED|95.0|3.0|31.9|||Fisher Exact|||||31.9|3.0|0.038
91481008|NCT00902161|182834960|SUPERIORITY_OR_OTHER||Least Squared Mean Treatment Difference|32.0||||0.005|TWO_SIDED|95.0|15.0|49.0||There was only 1 primary hypothesis, so no multiplicity adjustment was required.|A linear mixed effect (LME) model|||The p-value is for testing the null hypothesis that the difference on Rt(65) between the \[MK-0893 1g + Propranolol\] vs. \[PBO + Propranolol\] \>=60 min. If p-value \< 0.05, then the null hypothesis is rejected at the significance level of 0.05, thus supporting the primary hypothesis that the treatment difference is less than 60 minutes.||49|15|0.005
91481009|NCT00988325|182834976|SUPERIORITY_OR_OTHER||Median time to cessation of viral sheddi|119.0|||=|0.166|TWO_SIDED|95.0|113.0|230.0||p-value is for the comparison of the age cohorts (treatment groups)|Wilcoxon (Mann-Whitney)|Wilcoxon Test was used for testing homogeneity of survival curves|Median time was estimated from the Kaplan-Meier curve (unstratified)|||230|113|=0.166
91623030|NCT02505542|183139194|SUPERIORITY||Odds Ratio (OR)|11.385|||<|0.001|TWO_SIDED|95.0|5.952|21.778|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||21.778|5.952|<0.001
91623031|NCT02505542|183139194|SUPERIORITY||Odds Ratio (OR)|17.653|||<|0.001|TWO_SIDED|95.0|8.333|37.399|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||37.399|8.333|<0.001
91623032|NCT02505542|183139194|SUPERIORITY||Odds Ratio (OR)|11.863|||<|0.001|TWO_SIDED|95.0|5.67|24.822|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||24.822|5.670|<0.001
91623033|NCT02505542|183139195|SUPERIORITY||Odds Ratio (OR)|20.205|||<|0.001|TWO_SIDED|95.0|9.851|41.439|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||41.439|9.851|<0.001
91623034|NCT02505542|183139195|SUPERIORITY||Odds Ratio (OR)|12.07|||<|0.001|TWO_SIDED|95.0|6.275|23.218|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.218|6.275|<0.001
91713612|NCT01223937|183318696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.028|TWO_SIDED|95.0|-0.42|-0.02||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||"The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.02|-0.42|0.0280
91623035|NCT02505542|183139196|SUPERIORITY||Odds Ratio (OR)|20.891|||<|0.001|TWO_SIDED|95.0|10.21|42.744|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||42.744|10.210|<0.001
91623036|NCT02505542|183139196|SUPERIORITY||Odds Ratio (OR)|10.377|||<|0.001|TWO_SIDED|95.0|5.456|19.738|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||19.738|5.456|<0.001
91481010|NCT00988325|182834978|SUPERIORITY_OR_OTHER||Time to Resolution of Fever in Patients|14.5|||=|0.059|TWO_SIDED|95.0|12.0|20.0||The p-value is for the comparison of the age cohorts (not including Total)|Wilcoxon (Mann-Whitney)||Median time was estimated from the Kaplan-Meier curve (unstratified)|||20|12|=0.059
91481011|NCT01155219|182834982|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91481012|NCT03052764|182834983|SUPERIORITY||Least Squares Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.561|<|0.0001|TWO_SIDED|95.0|-3.68|-1.46|||ANCOVA|||||-1.46|-3.68|<.0001
91623037|NCT02505542|183139197|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|8.211|34.785|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.785|8.211|<0.001
91623038|NCT02505542|183139197|SUPERIORITY||Odds Ratio (OR)|12.072|||<|0.001|TWO_SIDED|95.0|5.954|24.476|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||24.476|5.954|<0.001
91623039|NCT02505542|183139198|SUPERIORITY||Odds Ratio (OR)|17.082|||<|0.001|TWO_SIDED|95.0|8.561|34.085|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.085|8.561|<0.001
91623040|NCT02505542|183139198|SUPERIORITY||Odds Ratio (OR)|11.503|||<|0.001|TWO_SIDED|95.0|5.939|22.278|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||22.278|5.939|<0.001
91623041|NCT02505542|183139199|OTHER||LS Mean Difference vs Placebo|-1.42|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.66|-1.17|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.17|-1.66|<0.001
91623042|NCT02505542|183139199|OTHER||LS Mean Difference vs Placebo|-1.21|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.45|<0.001
91661179|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.049|0.175|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.175|0.049|<0.001
91481013|NCT03052764|182834984|SUPERIORITY||Odds Ratio (OR)|6.15|||||TWO_SIDED|95.0|0.75|50.37|||||Values obtained were from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes)at each scheduled visit.|||50.37|0.75|
91623043|NCT02505542|183139200|OTHER||LS Mean Difference vs Placebo|-2.46|STANDARD_ERROR_OF_MEAN|0.268|<|0.001|TWO_SIDED|95.0|-2.99|-1.94|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.94|-2.99|<0.001
91623044|NCT02505542|183139200|OTHER||LS Mean Difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.267|<|0.001|TWO_SIDED|95.0|-2.77|-1.72|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.72|-2.77|<0.001
91661180|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.101|0.23|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.230|0.101|<0.001
91661181|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.138|||<|0.001|TWO_SIDED|95.0|0.074|0.203|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.203|0.074|<0.001
91713613|NCT01223937|183318697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0061|TWO_SIDED|95.0|1.19|2.86||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.||2.86|1.19|0.0061
91481014|NCT03052764|182834985|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.534|<|0.0001|TWO_SIDED|95.0|-3.3|-1.18|||ANCOVA|||||-1.18|-3.30|<.0001
91623045|NCT02505542|183139201|OTHER||LS Mean Difference vs Placebo|-1.57|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-2.04|-1.11|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.11|-2.04|<0.001
91623046|NCT02505542|183139201|OTHER||LS Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.9|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.90|<0.001
91661182|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.113|0.235|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.235|0.113|<0.001
91481015|NCT03052764|182834986|SUPERIORITY||Least Squares Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-3.73|-1.39|||ANCOVA|||||-1.39|-3.73|<.0001
91623047|NCT02505542|183139202|OTHER||LS Mean Difference vs Placebo|-0.2|STANDARD_ERROR_OF_MEAN|0.112|=|0.074|TWO_SIDED|95.0|-0.42|0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||0.02|-0.42|=0.074
91623048|NCT02505542|183139202|OTHER||LS Mean Difference vs Placebo|-0.24|STANDARD_ERROR_OF_MEAN|0.113|=|0.036|TWO_SIDED|95.0|-0.46|-0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.02|-0.46|=0.036
91623049|NCT02505542|183139203|SUPERIORITY||Odds Ratio (OR)|18.308|||<|0.001|TWO_SIDED|95.0|9.084|36.898|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||36.898|9.084|<0.001
91623050|NCT02505542|183139203|SUPERIORITY||Odds Ratio (OR)|12.02|||<|0.001|TWO_SIDED|95.0|6.255|23.098|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.098|6.255|<0.001
91623051|NCT02505542|183139204|OTHER||LS Mean Difference vs Placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.76|=|0.195|TWO_SIDED|95.0|-2.5|0.51|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.51|-2.50|=0.195
91623052|NCT02505542|183139204|OTHER||LS Mean Difference vs Placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.76|=|0.432|TWO_SIDED|95.0|-2.11|0.91|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.91|-2.11|=0.432
91661183|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.197|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.197|0.101|<0.001
91661184|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.104|0.004|0.035
91661185|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.301|TWO_SIDED|95.0|-0.024|0.076|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.076|-0.024|0.301
91661186|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.011|TWO_SIDED|95.0|0.014|0.11|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.110|0.014|0.011
91661187|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.294|TWO_SIDED|95.0|-0.08|0.024|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.024|-0.080|0.294
91713614|NCT01223937|183318698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0104|TWO_SIDED|95.0|-0.54|-0.07||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids, using last observation carried forward.||Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.||-0.07|-0.54|0.0104
91713615|NCT01223937|183318699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0586|TWO_SIDED|95.0|0.98|3.05||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||||3.05|0.98|0.0586
91713616|NCT01223937|183318700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.03||||0.0034|TWO_SIDED|95.0|16.35|81.7||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void, using last observation carried forward.||||81.70|16.35|0.0034
91713617|NCT01223937|183318701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.56||||0.0031|TWO_SIDED|95.0|-138.74|-28.38||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume, using last observation carried forward.||||-28.38|-138.74|0.0031
91661188|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.747|TWO_SIDED|95.0|-0.042|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.042|0.747
91661189|NCT03086460|183217290|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.155|TWO_SIDED|95.0|-0.014|0.086|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.086|-0.014|0.155
91481016|NCT03052764|182834987|SUPERIORITY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.192||0.0004|TWO_SIDED|95.0|-1.09|-0.32|||ANCOVA|||||-0.32|-1.09|0.0004
91623053|NCT02505542|183139205|OTHER||LS Mean Difference vs Placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.19|=|0.04|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||-0.02|-0.78|=0.040
91481017|NCT03052764|182834988|SUPERIORITY||Odds Ratio (OR)|13.03|||||TWO_SIDED|95.0|3.23|52.57|||||Values were obtained from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) at each scheduled visit.|||52.57|3.23|
91623054|NCT02505542|183139205|OTHER||LS Mean Difference vs Placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.19|=|0.074|TWO_SIDED|95.0|-0.73|0.03|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.03|-0.73|=0.074
91661190|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.136|||<|0.001|TWO_SIDED|95.0|0.065|0.207|||ANCOVA|||"Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment, which occurred after the randomization error."||0.207|0.065|<0.001
91661191|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.258|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.258|0.113|<0.001
91661192|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.092|0.238|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.092|<0.001
91661193|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.185|||<|0.001|TWO_SIDED|95.0|0.118|0.252|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.118|<0.001
91661194|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.176|||<|0.001|TWO_SIDED|95.0|0.121|0.231|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.231|0.121|<0.001
91661195|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.088|TWO_SIDED|95.0|-0.008|0.108|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.108|-0.008|0.088
91713618|NCT01223937|183318702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.91||||0.1829|TWO_SIDED|95.0|-180.42|34.6||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume, using last observation carried forward.||||34.60|-180.42|0.1829
91661196|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.323|TWO_SIDED|95.0|-0.029|0.088|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.088|-0.029|0.323
91661197|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.073|TWO_SIDED|95.0|-0.005|0.103|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.103|-0.005|0.073
91661198|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.489|TWO_SIDED|95.0|-0.08|0.039|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.039|-0.080|0.489
91481018|NCT01314911|182834989|SUPERIORITY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|4.6||0.0097|TWO_SIDED|95.0|-21.4|-3.0||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Oseltamivir arm minus the percent detectable in the Placebo arm.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Oseltamivir arm was better than the placebo arm and that the detectable rate in the Oseltamivir arm was 42.5% compared to 57.5% in the placebo arm (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-3.0|-21.4|0.0097
91661199|NCT03086460|183217291|SUPERIORITY||Median Difference (Final Values)|-0.001||||0.978|TWO_SIDED|95.0|-0.057|0.056|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.056|-0.057|0.978
91661200|NCT03086460|183217291|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.484|TWO_SIDED|95.0|-0.037|0.077|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.077|-0.037|0.484
91661201|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.048|0.166|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.166|0.048|<0.001
91661202|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.096|0.217|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.096|<0.001
91661203|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.073|0.193|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.193|0.073|<0.001
91661204|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.103|0.217|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.103|<0.001
91661205|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.102|0.192|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.192|0.102|<0.001
91661206|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.041|TWO_SIDED|95.0|0.002|0.098|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.098|0.002|0.041
91661207|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.275|TWO_SIDED|95.0|-0.021|0.073|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.073|-0.021|0.275
91661208|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.053||||0.021|TWO_SIDED|95.0|0.008|0.098|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.098|0.008|0.021
91661209|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.35|TWO_SIDED|95.0|-0.073|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.073|0.350
91661210|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.886|TWO_SIDED|95.0|-0.044|0.051|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.051|-0.044|0.886
91713619|NCT03284853|183318705|OTHER|The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.|||||<|0.05||||||Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).|Regression, Linear|Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points||Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.||||<0.05
91713620|NCT00765817|183318741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91713621|NCT00765817|183318742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91713622|NCT00765817|183318743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91713623|NCT00765817|183318744|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||ANCOVA|||||||0.174
91713624|NCT00765817|183318746|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||||||0.203
91661211|NCT03086460|183217292|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.254|TWO_SIDED|95.0|-0.02|0.074|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.074|-0.020|0.254
91661212|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.114|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.169|0.060|<0.001
91661213|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.154|||<|0.001|TWO_SIDED|95.0|0.099|0.208|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.099|<0.001
91661214|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.138|0.247|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.247|0.138|<0.001
91713625|NCT00765817|183318747|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||||||0.063
91713626|NCT00765817|183318748|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||ANCOVA|||||||0.745
91713627|NCT00765817|183318749|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||ANCOVA|||||||0.933
91713628|NCT00765817|183318750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91713629|NCT00765817|183318751|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||ANCOVA|||||||0.226
91623055|NCT02666508|183139246|OTHER|Test conducted was a test of difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in DPIA from pre to post.|Mean Difference (Net)|-1.02||||0.001|TWO_SIDED|95.0|-1.6|-0.44|||Repeated Measures ANOVA|||||-0.44|-1.60|0.001
91623056|NCT02666508|183139247|OTHER|Test conducted was a test of the difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in hsCRP|Mean Difference (Net)|-0.18||||0.459|TWO_SIDED|95.0|-0.69|0.32|||Repeated Measures ANOVA|||||0.32|-0.69|0.459
91623057|NCT00318565|183139267|SUPERIORITY_OR_OTHER||Binomial distribution|93.3||||0.05|ONE_SIDED|95.0|90.1||||Exact binomial distribution|||An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.|||90.1|.05
91623058|NCT00318565|183139268|SUPERIORITY_OR_OTHER||Binomial Distribution|1.5||||0.05|ONE_SIDED|95.0||7.0|||Exact Binomial Distribution|||The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%||7||.05
91623059|NCT00835003|183139276|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group|Risk Ratio (RR)|0.86||||0.31|TWO_SIDED|95.0|0.65|1.15|||Chi-squared|||||1.15|0.65|0.31
91623060|NCT01804036|183139285|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
91623061|NCT01804036|183139286|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|||||||0.11
91623062|NCT01804036|183139287|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
91623063|NCT01804036|183139288|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANCOVA|||||||0.08
91623064|NCT01804036|183139289|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANCOVA|||||||0.20
91623065|NCT01804036|183139290|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
91661215|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.216|||<|0.001|TWO_SIDED|95.0|0.163|0.268|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.268|0.163|<0.001
91623066|NCT01804036|183139291|SUPERIORITY_OR_OTHER|||||||0.52|||||||ANCOVA|||||||0.52
91623067|NCT01804036|183139292|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
91623068|NCT01804036|183139293|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||||||0.94
91623069|NCT01804036|183139294|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
91623070|NCT01804036|183139295|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANCOVA|||||||0.49
91623071|NCT01804036|183139296|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91623072|NCT01804036|183139297|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91623073|NCT01804036|183139298|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
91623074|NCT03859960|183139304|OTHER|||||||0.006|||||||Pearson correlation test|||||||0.006
91623075|NCT03859960|183139304|OTHER|||||||0.23||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.23
91623076|NCT03859960|183139305|OTHER|||||||0.001||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.001
91623077|NCT03859960|183139305|OTHER|||||||0.731|||||||Pearson correlation test|||||||0.731
91623078|NCT03859960|183139306|OTHER|||||||0.214|||||||Pearson correlation test|||||||0.214
91623079|NCT03859960|183139306|OTHER|||||||0.993||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.993
91623080|NCT03859960|183139307|OTHER|||||||0.41|||||||Pearson correlation test|||||||0.41
91661216|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.12|0.224|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.224|0.120|<0.001
91623081|NCT03859960|183139307|OTHER|||||||0.676|||||||Pearson correlation test|||||||0.676
91623082|NCT03859960|183139308|OTHER|||||||0.511||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.511
91623083|NCT03859960|183139308|OTHER|||||||0.248|||||||Pearson correlation test|||||||0.248
91623084|NCT03859960|183139309|OTHER|||||||0.654|||||||Pearson correlation test|||||||0.654
91623085|NCT03859960|183139309|OTHER|||||||0.025|||||||Pearson correlation test|||||||0.025
91623086|NCT00830960|183139320|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference in PRU|-183.0|||<|0.0001|TWO_SIDED|95.0|-229.0|-137.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-137|-229|<0.0001
91623087|NCT00830960|183139320|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-139.0|||<|0.0001|TWO_SIDED|95.0|-177.0|-102.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-102|-177|<0.0001
91623088|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-57.0||||0.0058|TWO_SIDED|95.0|-97.0|-17.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-17|-97|0.0058
91661217|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.165|TWO_SIDED|95.0|-0.016|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.016|0.165
91713630|NCT00765817|183318752|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||||||0.026
91713631|NCT00765817|183318753|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||||||0.070
91713632|NCT00765817|183318754|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||ANCOVA|||||||0.011
91481019|NCT01314911|182834992|SUPERIORITY|||||||0.0243||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.0243
91481020|NCT01314911|182834993|SUPERIORITY|||||||0.41||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.41
91481021|NCT01314911|182834994|SUPERIORITY|||||||0.88||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.88
91481022|NCT01314911|182834995|SUPERIORITY|||||||0.7461||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.7461
91481023|NCT01314911|182834996|SUPERIORITY|||||||0.1501||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.1501
91481024|NCT01314911|182834997|SUPERIORITY|||||||0.3025||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.3025
91525081|NCT00335257|182925465|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE|Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2||1.3|0.5|
91623089|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-35.0||||0.0365|TWO_SIDED|95.0|-68.0|-2.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel"|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-2|-68|0.0365
91623090|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-68.0||||0.0004|TWO_SIDED|95.0|-104.0|-32.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-32|-104|0.0004
91661218|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.005|TWO_SIDED|95.0|0.024|0.132|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.132|0.024|0.005
91713633|NCT00765817|183318755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91481025|NCT01314911|182834998|SUPERIORITY|||||||0.5466||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.5466
91481026|NCT01314911|182835000|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5311|TWO_SIDED|95.0|-1.4|3.0||P-value was not adjusted for multiple interim analyses.|two-sample binomial exact test|The two-sample binomial exact test was performed in PROC STATXACT.|The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|||3.0|-1.4|0.5311
91481027|NCT01314911|182835001|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8498|TWO_SIDED|95.0|-3.8|4.7||P-value was not adjusted for multiple interim analyses.|Z test||The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|This test compared the difference in percentages of participants with at least one complication between two randomized arms.||4.7|-3.8|0.8498
91481028|NCT01314911|182835003|SUPERIORITY||Mean Difference (Final Values)|-13.6||||0.0021|TWO_SIDED|95.0|-22.2|-5.1||P-value was not adjusted for multiple interim analyses.|Z test||||The difference in percents was calculated as the percent with detectable in the Oseltamivir arm minus the percent with detectable in the placebo arm.|-5.1|-22.2|0.0021
91481029|NCT01314911|182835006|SUPERIORITY|||||||0.022||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.022
91481030|NCT03150485|182835056|SUPERIORITY|Superiority was established is the lower limit of the 95% confidence interval was above 50%.|Estimated Proportion|77.27|||||TWO_SIDED|95.0|56.15|90.29|||Agresti-Coull|||The Agresti-Coull method was used to estimate the confidence interval of the binomial proportions of subjects with less than 2 lens modifications.||90.29|56.15|
91481031|NCT01362595|182835099|OTHER||||||||||||||||||Due to the small sample size, the statistical approach is primarily descriptive in nature.|||
91481032|NCT04243421|182835134|OTHER||Median Difference (Final Values)|6.0||||0.0007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0007
91481033|NCT04243421|182835135|OTHER||Median Difference (Final Values)|1.25||||0.0005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0005
91481034|NCT04243421|182835135|OTHER||Median Difference (Final Values)|1.0||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0034
91481035|NCT04243421|182835136|OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91481036|NCT02284178|182835137|SUPERIORITY|||||||0.432|||||||GEE analysis|||||||0.432
91481037|NCT02284178|182835138|SUPERIORITY|||||||0.684|||||||GEE|||||||0.684
91525082|NCT03324880|182925467|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.189|=|0.003|TWO_SIDED|95.0|-0.9|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom subscale score.|-0.15|-0.90|=0.003
91661219|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.049|0.153|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.049|<0.001
91713634|NCT00765817|183318756|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||Negative binomial regression model|||||||0.666
91481038|NCT02284178|182835139|SUPERIORITY|||||||0.858|||||||Chi-squared|||||||0.858
91481039|NCT02284178|182835141|SUPERIORITY|||||||0.46|||||||GEE analysis|||||||0.460
91481040|NCT02284178|182835142|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||0.214
91481041|NCT02284178|182835143|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
91623091|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-160.0|||<|0.0001|TWO_SIDED|95.0|-211.0|-110.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-110|-211|<0.0001
91661220|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.187|TWO_SIDED|95.0|-0.019|0.097|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.097|-0.019|0.187
91481042|NCT02284178|182835144|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
91481043|NCT04123665|182835149|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.04|||ANCOVA|Analysis of Covariance (ANCOVA) with factors for treatment group and gender, and the baseline whole mouth mean BI and whole mouth MGI as covariates.|Difference is first named treatment (experimental) minus second named treatment (control).|||-0.04|-0.11|<0.0001
91623092|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-115.0|||<|0.0001|TWO_SIDED|95.0|-156.0|-73.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-156|<0.0001
91623093|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-171.0|||<|0.0001|TWO_SIDED|95.0|-216.0|-125.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-125|-216|<0.0001
91623094|NCT00830960|183139321|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-212.0|||<|0.0001|TWO_SIDED|95.0|-259.0|-167.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-167|-259|<0.0001
91623095|NCT00830960|183139322|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-119.0|||<|0.0001|TWO_SIDED|95.0|-166.0|-73.0||"P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|LS Mean Difference in PRU|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-166|<0.0001
91623096|NCT00830960|183139322|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-113.0|||<|0.0001|TWO_SIDED|95.0|-154.0|-73.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-154|<0.0001
91661221|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.028|TWO_SIDED|95.0|0.007|0.116|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.007|0.028
91661222|NCT03086460|183217293|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.406|TWO_SIDED|95.0|-0.031|0.076|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.076|-0.031|0.406
91713635|NCT00765817|183318757|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||||||0.486
91623097|NCT00830960|183139322|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-85.0|||<|0.0001|TWO_SIDED|95.0|-121.0|-48.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-48|-121|<0.0001
91661223|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.116|0.23|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.230|0.116|<0.001
91481044|NCT00958789|182835188|NON_INFERIORITY|"For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority.~H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta."|Mean Difference (Final Values)|70.7|||||ONE_SIDED|95.0|64.43||||||||||64.43|
91481045|NCT04190680|182835264|OTHER|||||||0.001|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T1 (directly after the evaluation lesson).||||0.001
91661224|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.203|||<|0.001|TWO_SIDED|95.0|0.146|0.26|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.260|0.146|<0.001
91713636|NCT06597084|183318768|OTHER||Percentiles of time to first US|92.0||||0.2081|TWO_SIDED|95.0|25.0|95.0|||Log Rank|||||95|25|0.2081
91713637|NCT06597084|183318774|OTHER||Overall Survival|||||0.0542|||||||Log Rank|||||||0.0542
91713638|NCT01043133|183318784|SUPERIORITY_OR_OTHER||log-binomial|3.97|STANDARD_ERROR_OF_MEAN|3.97||0.01|TWO_SIDED|95.0|1.34|11.79|||log-binomial regression||Robust Huber-White standard errors account for clustering|||11.79|1.34|.01
91623098|NCT00830960|183139322|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-35.0||||0.0647|TWO_SIDED|95.0|-72.0|2.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||2|-72|0.0647
91623099|NCT00830960|183139322|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-100.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-57.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-57|-143|<0.0001
91623100|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|15.0||||0.0072|TWO_SIDED|95.0|4.0|27.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|4|0.0072
91623101|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|9.0||||0.0647|TWO_SIDED|95.0|-1.0|18.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||18|-1|0.0647
91623102|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.0054|TWO_SIDED|95.0|3.0|19.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||19|3|0.0054
91623103|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|51.0|||<|0.0001|TWO_SIDED|95.0|36.0|66.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||66|36|<0.0001
91623104|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|36.0|||<|0.0001|TWO_SIDED|95.0|23.0|48.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||48|23|<0.0001
91623105|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|49.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||61|36|<0.0001
91623106|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|62.0|||<|0.0001|TWO_SIDED|95.0|47.0|76.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||76|47|<0.0001
91661225|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.223|||<|0.001|TWO_SIDED|95.0|0.166|0.28|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.280|0.166|<0.001
91623107|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|59.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||59|36|<0.0001
91661226|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.27|||<|0.001|TWO_SIDED|95.0|0.216|0.325|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.325|0.216|<0.001
91661227|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.187|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.187|<0.001
91661228|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.308|TWO_SIDED|95.0|-0.028|0.089|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.089|-0.028|0.308
91661229|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.082|TWO_SIDED|95.0|-0.006|0.107|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.107|-0.006|0.082
91713639|NCT01043133|183318785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_DEVIATION|2.78||0.05|TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-.03|-2.48|.05
91661230|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.097|||<|0.001|TWO_SIDED|95.0|0.043|0.152|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.152|0.043|<0.001
91661231|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.52|TWO_SIDED|95.0|-0.041|0.08|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.080|-0.041|0.520
91661232|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.067||||0.022|TWO_SIDED|95.0|0.01|0.124|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.124|0.010|0.022
91661233|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
91661234|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.095|0.21|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.210|0.095|<0.001
91661235|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.131|0.249|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.249|0.131|<0.001
91661236|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.113|0.228|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.228|0.113|<0.001
91661237|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.217|||<|0.001|TWO_SIDED|95.0|0.162|0.272|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.272|0.162|<0.001
91661238|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.144|0.252|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.144|<0.001
91661239|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.203|TWO_SIDED|95.0|-0.02|0.095|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.020|0.203
91661240|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.542|TWO_SIDED|95.0|-0.039|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.039|0.542
91661241|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.021|TWO_SIDED|95.0|0.01|0.119|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|0.010|0.021
91661242|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|95.0|-0.08|0.04|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.040|-0.080|0.510
91661243|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.352|TWO_SIDED|95.0|-0.03|0.084|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.084|-0.030|0.352
91661244|NCT03086460|183217294|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
91661245|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.122|0.241|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.241|0.122|<0.001
91661246|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.192|||<|0.001|TWO_SIDED|95.0|0.133|0.251|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.251|0.133|<0.001
91661247|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.215|||<|0.001|TWO_SIDED|95.0|0.156|0.275|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.275|0.156|<0.001
91661248|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.252|||<|0.001|TWO_SIDED|95.0|0.195|0.309|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.309|0.195|<0.001
91661249|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.182|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.182|<0.001
91623108|NCT00830960|183139323|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|56.0|||<|0.0001|TWO_SIDED|95.0|44.0|68.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||68|44|<0.0001
91713640|NCT00490971|183318800|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 85.0% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0195.|Weighted Z- test|||Null hypothesis: there is no difference between Pali/Pali and Pali/Placebo in the time to recurrence of any mood symptoms related to bipolar I disorder. An interim analysis was performed when approximately 85% of the required number of recurrences were reported in Pali/Pali and Pali/Placebo treatment groups. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||0.017
91713641|NCT00490971|183318801|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 81.9% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0198.|Weighted z-test|||At the time of interim analysis of the primary efficacy endpoint, the proportion of recurrence of manic symptoms was 81.9% of the number of recurrence of manic symptoms at final analysis. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||<0.001
91661250|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.723|TWO_SIDED|95.0|-0.049|0.071|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.071|-0.049|0.723
91623109|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|38.0|||<|0.0001|TWO_SIDED|95.0|27.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|27|<0.0001
91623110|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|21.0|42.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||42|21|<0.0001
91623111|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|17.0||||0.0026|TWO_SIDED|95.0|6.0|28.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||28|6|0.0026
91623112|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|37.0|||<|0.0001|TWO_SIDED|95.0|24.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|24|<0.0001
91623113|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|35.0||||0.0001|TWO_SIDED|95.0|18.0|52.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||52|18|0.0001
91623114|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|28.0||||0.0005|TWO_SIDED|95.0|13.0|44.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||44|13|0.0005
91623115|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.1898|TWO_SIDED|95.0|-5.0|27.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|-5|0.1898
91661251|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.257|TWO_SIDED|95.0|-0.025|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.025|0.257
91623116|NCT00830960|183139324|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|18.0|45.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||45|18|<0.0001
91661252|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.016|TWO_SIDED|95.0|0.014|0.128|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.128|0.014|0.016
91713642|NCT00490971|183318802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.53|1.46||Cox proportional hazards regression was performed with treatment (Pali/Placebo, Pali/Pali) as a factor. The 2 treatment groups were compared by means of a hazard ratio (Pali/Placebo: Pali/Pali)|Regression, Cox|The percent of participants who reported recurrence of depressive symptoms was: 18% Pali/Placebo, 24% Pali/Pali.|Hazard ratio was estimated with Pali/Placebo in the numerator and Pali/Pali in the denominator|||1.46|0.53|
91713643|NCT00490971|183318803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.92|-1.98|||ANCOVA|ANCOVA model with treatment group (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||-1.98|-6.92|<0.001
91481046|NCT04190680|182835264|OTHER|||||||0.31|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T2 (three months after the evaluation lesson).||||0.31
91481047|NCT04190680|182835265|OTHER|||||||0.55|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T1 (directly after evaluation lesson).||||0.55
91481048|NCT04190680|182835265|OTHER|||||||0.33|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T2 (three months after evaluation lesson).||||0.33
91481049|NCT04190680|182835266|OTHER|||||||0.004|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T1 (directly after evaluation lesson).||||0.004
91623117|NCT00830960|183139326|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-110.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-76.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-76|-143|<0.0001
91623118|NCT00830960|183139326|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-92.0|||<|0.0001|TWO_SIDED|95.0|-123.0|-60.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-60|-123|<0.0001
91623119|NCT00830960|183139326|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-51.0||||0.002|TWO_SIDED|95.0|-83.0|-19.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-19|-83|0.0020
91623120|NCT00830960|183139333|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
91623121|NCT00830960|183139333|SUPERIORITY_OR_OTHER|||||||0.427||95.0|||||Fisher Exact|||||||0.427
91623122|NCT00830960|183139333|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||||||0.683
91623123|NCT00830960|183139333|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||||||0.034
91623124|NCT02703987|183139348|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0801|TWO_SIDED|95.0|-0.04|0.67|||Mixed Models Analysis|||||0.67|-0.04|0.0801
91623125|NCT02703987|183139349|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0714|TWO_SIDED|95.0|-0.03|0.71|||Mixed Models Analysis|||||0.71|-0.03|0.0714
91623126|NCT02703987|183139350|SUPERIORITY||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.85||0.0609|TWO_SIDED|95.0|-0.48|19.6|||Mixed Models Analysis|||||19.6|-0.48|0.0609
91623127|NCT01309841|183139354|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.062|1.795|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.795|1.062|0.015
91623128|NCT01309841|183139354|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.509||||0.001|TWO_SIDED|95.0|1.168|1.949|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.949|1.168|0.001
91623129|NCT01309841|183139355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.479||||0.028|TWO_SIDED|95.0|1.038|2.107||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.107|1.038|0.028
91623130|NCT01309841|183139355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.691||||0.002|TWO_SIDED|95.0|1.205|2.373||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.373|1.205|0.002
91623131|NCT01309841|183139357|SUPERIORITY_OR_OTHER||LS mean difference|0.55|||<|0.001|TWO_SIDED|95.0|0.24|0.86|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.86|0.24|<0.001
91623132|NCT01309841|183139357|SUPERIORITY_OR_OTHER||Ls mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.51|1.13|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||1.13|0.51|<0.001
91623133|NCT01309841|183139358|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.176|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.04|-0.23|0.176
91623134|NCT01309841|183139358|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.008|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.05|-0.32|0.008
91623135|NCT01309841|183139359|SUPERIORITY_OR_OTHER||LS mean difference|0.05||||0.564|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.23|-0.12|0.564
91481050|NCT04190680|182835266|OTHER|||||||0.84|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T2 (three months after evaluation lesson).||||0.84
91481051|NCT04190680|182835267|OTHER|||||||0.002|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T1 (directly after evaluation lesson).||||0.002
91481052|NCT04190680|182835267|OTHER|||||||0.16|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T2 (three months after evaluation lesson).||||0.16
91481053|NCT04190680|182835268|OTHER|||||||0.01|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T1 (directly after evaluation lesson).||||0.01
91623136|NCT01309841|183139359|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.042|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.36|0.01|0.042
91623137|NCT01309841|183139360|SUPERIORITY_OR_OTHER||LS mean difference|3.87||||0.094|TWO_SIDED|95.0|-0.66|8.39|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||8.39|-0.66|0.094
91623138|NCT01309841|183139360|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.001|TWO_SIDED|95.0|4.04|13.14|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||13.14|4.04|<0.001
91661253|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.464|TWO_SIDED|95.0|-0.039|0.086|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.039|0.464
91661254|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.048|TWO_SIDED|95.0|0.0|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|0.000|0.048
91661255|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.219|TWO_SIDED|95.0|-0.022|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.022|0.219
91713644|NCT00490971|183318804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.763|TWO_SIDED|95.0|-1.87|2.55|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||2.55|-1.87|0.763
91481054|NCT04190680|182835268|OTHER|||||||0.19|||||||Regression, Linear|A three-level linear mixed model analysis, with classes as third level, participants as second level, and measurements as first level, was used.||Statistical analysis at T2 (three months after evaluation lesson).||||0.19
91481055|NCT03780400|182835269|OTHER|test for within group change from baseline to 4 month follow-up||||||0.5145|||||||t-test, 2 sided|||||||0.5145
91481056|NCT03780400|182835270|OTHER|test for within group change from baseline to 4 month follow-up||||||0.3683|||||||t-test, 2 sided|||||||0.3683
91481057|NCT03780400|182835271|OTHER|test for within group change from baseline to 4 month follow-up||||||0.9858|||||||t-test, 2 sided|||||||0.9858
91481058|NCT03780400|182835272|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91481059|NCT03780400|182835273|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91481060|NCT01850602|182835274|NON_INFERIORITY|"Non-Inferiority margin: 1.0 mg/dL~Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less."|Mean Difference (Final Values)|-0.34||||0.02|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||||-0.05|-0.63|0.020
91481061|NCT00740051|182835284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.86|-0.29||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-0.29|-0.86|<0.0001
91481062|NCT00740051|182835285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.88|-0.32||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.||-0.32|-0.88|<0.0001
91481063|NCT00740051|182835286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5|STANDARD_ERROR_OF_MEAN|5.4||0.0002||95.0|-31.1|-9.9||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-9.9|-31.1|0.0002
91481064|NCT00740051|182835287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.576||||0.0374||95.0|1.057|6.279||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||6.279|1.057|0.0374
91481065|NCT00740051|182835288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.285||||0.1281||95.0|0.71|15.196||No adjustment of p-values|Regression, Logistic|||Linagliptin vs. Placebo||15.196|0.710|0.1281
91623139|NCT01309841|183139361|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.011|TWO_SIDED|95.0|0.12|0.96|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.96|0.12|0.011
91623140|NCT01309841|183139361|SUPERIORITY_OR_OTHER||LS mean difference|0.99|||<|0.001|TWO_SIDED|95.0|0.57|1.41|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.41|0.57|<0.001
91623141|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.273|TWO_SIDED|95.0|-0.21|0.06||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.21|0.273
91661256|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.1|0.226|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.226|0.100|<0.001
91661257|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.126|0.254|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.254|0.126|<0.001
91661258|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.103|0.229|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.229|0.103|<0.001
91661259|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.206|||<|0.001|TWO_SIDED|95.0|0.146|0.266|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.266|0.146|<0.001
91661260|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.125|0.243|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.243|0.125|<0.001
91481066|NCT00740051|182835289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.801||||0.0046||95.0|1.374|5.711||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||5.711|1.374|0.0046
91623142|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.089|TWO_SIDED|95.0|-0.26|0.02||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.26|0.089
91623143|NCT01309841|183139363|SUPERIORITY_OR_OTHER||Slope|0.02||||0.849|TWO_SIDED|95.0|-0.14|0.17||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.17|-0.14|0.849
91623144|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.749|TWO_SIDED|95.0|-0.18|0.13||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.13|-0.18|0.749
91623145|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.062|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.062
91623146|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.003|TWO_SIDED|95.0|-0.35|-0.07||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.35|0.003
91713645|NCT00490971|183318805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.01|TWO_SIDED|95.0|1.4|10.09|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||10.09|1.40|0.010
91713646|NCT00490971|183318806|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|ANCOVA Model on ranks with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||||0.007
91481067|NCT02502006|182835298|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91481068|NCT02502006|182835299|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
91481069|NCT02502006|182835300|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91481070|NCT02502006|182835301|SUPERIORITY|||||||0.2217|||||||ANOVA|||||||0.2217
91481071|NCT02502006|182835302|SUPERIORITY|||||||0.77||||||Adjusted for multiple comparisons|ANOVA|||||||0.77
91481072|NCT02502006|182835302|SUPERIORITY|||||||0.18||||||Adjusted for multiple comparisons|ANOVA|||||||0.18
91481073|NCT02502006|182835303|SUPERIORITY|||||||0.57||||||Adjusted for multiple comparisons|ANOVA|||||||0.57
91481074|NCT02502006|182835303|SUPERIORITY|||||||0.07||||||Adjusted for multiple comparisons|ANOVA|||||||0.07
91481075|NCT02502006|182835304|SUPERIORITY|||||||0.88||||||Adjusted for multiple comparisons|ANOVA|||||||0.88
91623147|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.202|TWO_SIDED|95.0|-0.29|0.06||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.29|0.202
91623148|NCT01309841|183139363|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.072|TWO_SIDED|95.0|-0.34|0.01||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.34|0.072
91661261|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.4|TWO_SIDED|95.0|-0.036|0.09|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.090|-0.036|0.400
91661262|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.931|TWO_SIDED|95.0|-0.059|0.064|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.064|-0.059|0.931
91481076|NCT02502006|182835304|SUPERIORITY||||||<|0.05||||||Adjusted for multiple comparisons|ANOVA|||||||<0.05
91481077|NCT04445792|182835320|SUPERIORITY|||||||0.7195|||||||Wilcoxon (Mann-Whitney)|||||||0.7195
91623149|NCT01309841|183139364|SUPERIORITY_OR_OTHER||LS mean difference|-0.02||||0.831|TWO_SIDED|95.0|-0.25|0.2|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.20|-0.25|0.831
91623150|NCT01309841|183139364|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.141|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.06|-0.41|0.141
91623151|NCT02475395|183139365|OTHER||Sensitivity|90.0|||||TWO_SIDED|95.0|79.9|95.3|||||Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.|||95.3|79.9|
91623152|NCT02475395|183139365|OTHER||Specificity|93.3|||||TWO_SIDED|95.0|88.7|96.1|||||Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.|||96.1|88.7|
91623153|NCT02475395|183139366|OTHER||Sensitivity|95.0|||||TWO_SIDED|95.0|86.3|98.3||||||||98.3|86.3|
91623154|NCT02475395|183139366|OTHER||Specificity|94.9|||||TWO_SIDED|95.0|90.6|97.3||||||||97.3|90.6|
91661263|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.16|TWO_SIDED|95.0|-0.017|0.102|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.102|-0.017|0.160
91661264|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.464|TWO_SIDED|95.0|-0.09|0.041|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.041|-0.090|0.464
91661265|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.623|TWO_SIDED|95.0|-0.047|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.047|0.623
91661266|NCT03086460|183217295|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.197|TWO_SIDED|95.0|-0.021|0.101|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.101|-0.021|0.197
91661267|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.098|TWO_SIDED|95.0|-0.01|0.113|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.113|-0.010|0.098
91661268|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.002|TWO_SIDED|95.0|0.035|0.159|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.159|0.035|0.002
91661269|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.002|TWO_SIDED|95.0|0.039|0.163|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.163|0.039|0.002
91713647|NCT00255164|183318823|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
91481078|NCT04445792|182835320|SUPERIORITY|||||||0.8054|||||||Wilcoxon (Mann-Whitney)|||||||0.8054
91481079|NCT04445792|182835320|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
91481080|NCT04445792|182835321|SUPERIORITY|||||||0.4385|||||||Wilcoxon (Mann-Whitney)|||||||0.4385
91623155|NCT02475395|183139367|OTHER||Sensitivity|96.7|||||TWO_SIDED|95.0|88.7|99.1||||||||99.1|88.7|
91481081|NCT04445792|182835321|SUPERIORITY|||||||0.7185|||||||Wilcoxon (Mann-Whitney)|||||||0.7185
91481082|NCT04445792|182835321|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
91481083|NCT04445792|182835322|SUPERIORITY|||||||0.9222|||||||Wilcoxon (Mann-Whitney)|||||||0.9222
91481084|NCT04445792|182835322|SUPERIORITY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||||||0.1918
91481085|NCT04445792|182835322|SUPERIORITY|||||||0.0119|||||||Wilcoxon (Mann-Whitney)|||||||0.0119
91481086|NCT04445792|182835323|SUPERIORITY|||||||0.6971|||||||Wilcoxon (Mann-Whitney)|||||||0.6971
91481087|NCT04445792|182835323|SUPERIORITY|||||||0.2309|||||||Wilcoxon (Mann-Whitney)|||||||0.2309
91623156|NCT02475395|183139367|OTHER||Specificity|93.8|||||TWO_SIDED|95.0|89.2|96.5||||||||96.5|89.2|
91623157|NCT03103906|183139379|OTHER||Difference in proportion|2.56||||0.3334|TWO_SIDED|95.0|-19.99|25.07|||Chi-squared|||||25.07|-19.99|0.3334
91623158|NCT00764478|183139387|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.41||0.0136|TWO_SIDED|95.0|-6.3|-0.7||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.7|-6.3|0.0136
91623159|NCT00764478|183139387|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.0|STANDARD_ERROR_OF_MEAN|1.43||0.01|TWO_SIDED|95.0|-6.9|-1.2||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-1.2|-6.9|0.0100
91661270|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.063|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.063|<0.001
91661271|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.054|0.171|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.171|0.054|<0.001
91481088|NCT04445792|182835323|SUPERIORITY|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||||||0.0441
91713648|NCT00255164|183318823|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
91713649|NCT00255164|183318823|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
91481089|NCT04445792|182835324|SUPERIORITY|||||||0.7988|||||||Wilcoxon (Mann-Whitney)|||||||0.7988
91481090|NCT04445792|182835324|SUPERIORITY|||||||0.0483|||||||Wilcoxon (Mann-Whitney)|||||||0.0483
91481091|NCT04445792|182835324|SUPERIORITY|||||||0.0104|||||||Wilcoxon (Mann-Whitney)|||||||0.0104
91481092|NCT04445792|182835325|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
91481093|NCT04445792|182835325|SUPERIORITY|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||||||0.2348
91481094|NCT04445792|182835325|SUPERIORITY|||||||0.0517|||||||Wilcoxon (Mann-Whitney)|||||||0.0517
91481095|NCT04445792|182835326|SUPERIORITY|||||||0.6835|||||||Wilcoxon (Mann-Whitney)|||||||0.6835
91623160|NCT00764478|183139388|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.8|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.2|-0.8|0.0100
91623161|NCT00764478|183139388|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0052|TWO_SIDED|95.0|-0.9|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-0.2|-0.9|0.0052
91481096|NCT04445792|182835326|SUPERIORITY|||||||0.0205|||||||Wilcoxon (Mann-Whitney)|||||||0.0205
91481097|NCT04445792|182835326|SUPERIORITY|||||||0.0036|||||||Wilcoxon (Mann-Whitney)|||||||0.0036
91481098|NCT04445792|182835327|SUPERIORITY|||||||0.5878|||||||Wilcoxon (Mann-Whitney)|||||||0.5878
91481099|NCT04445792|182835327|SUPERIORITY|||||||0.1051|||||||Wilcoxon (Mann-Whitney)|||||||0.1051
91481100|NCT04445792|182835327|SUPERIORITY|||||||0.0292|||||||Wilcoxon (Mann-Whitney)|||||||0.0292
91481101|NCT04445792|182835328|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91481102|NCT04445792|182835328|SUPERIORITY|||||||0.5973|||||||Chi-squared|||||||0.5973
91481103|NCT04445792|182835328|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
91623162|NCT00764478|183139389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5352||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.5352
91623163|NCT00764478|183139389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.4274
91623164|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-2.7|STANDARD_ERROR_OF_MEAN|0.78||0.0007|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-1.1|-4.2|0.0007
91623165|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.4|-1.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-1.3|-4.4|0.0003
91623166|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-1.8|-5.4|<0.0001
91623167|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.7|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-5.5|-1.9|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-1.9|-5.5|<0.0001
91623168|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.12||0.0021|TWO_SIDED|95.0|-5.7|-1.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-1.3|-5.7|0.0021
91623169|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.2|STANDARD_ERROR_OF_MEAN|1.13||0.0002|TWO_SIDED|95.0|-6.4|-2.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-2.0|-6.4|0.0002
91623170|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.35||0.1907|TWO_SIDED|95.0|-4.4|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-4.4|0.1907
91623171|NCT00764478|183139390|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.37||0.0238|TWO_SIDED|95.0|-5.8|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.4|-5.8|0.0238
91623172|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2922|||||||Cochran-Mantel-Haenszel|||Day 2||||0.2922
91623173|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1001|||||||Cochran-Mantel-Haenszel|||Day 2||||0.1001
91623174|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
91623175|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
91623176|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0194|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0194
91623177|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0841|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0841
91623178|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4858|||||||Cochran-Mantel-Haenszel|||Day 14||||0.4858
91623179|NCT00764478|183139391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2496|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2496
91623180|NCT00764478|183139392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|||||||Cochran-Mantel-Haenszel|||||||0.2912
91481104|NCT03560739|182835420|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|Geo-mean ratio|1.03|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of AUCtau||1.25|.8|
91481105|NCT03560739|182835420|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.3131|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion|Criteria 2 for bioequivalence testing of AUCtau||0||
91713650|NCT00255164|183318824|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91713651|NCT00255164|183318824|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91713652|NCT00255164|183318824|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
91713653|NCT00255164|183318826|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
91713654|NCT00255164|183318826|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
91481106|NCT03560739|182835421|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|geo-mean ratio|1.0|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of Cmax||1.25|.8|
91481107|NCT03560739|182835421|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.2446|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.|Criteria 2 for bioequivalence testing of Cmax||0||
91481108|NCT03228420|182835443|SUPERIORITY||||||<|0.001||||||2-sided alpha level of 0.05|Fisher Exact|||||||<0.001
91623181|NCT00764478|183139392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151|||||||Cochran-Mantel-Haenszel|||||||0.1151
91623182|NCT00764478|183139394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|||Day 7||||0.0019
91623183|NCT00764478|183139394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||ANCOVA|||Day 7||||0.0045
91623184|NCT00764478|183139394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112|||||||ANCOVA|||Day 21||||0.0112
91623185|NCT00764478|183139394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||ANCOVA|||Day 21||||0.0021
91623186|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.4|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-0.1|-0.4|<0.0001
91623187|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.3|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-0.1|-0.3|0.0076
91623188|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-0.2|-0.6|0.0004
91623189|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.5|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-0.1|-0.5|0.0040
91623190|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0061|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0061
91623191|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0031|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0031
91623192|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1086|TWO_SIDED|95.0|-0.5|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-0.5|0.1086
91623193|NCT00764478|183139395|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0376|TWO_SIDED|95.0|-0.6|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.0|-0.6|0.0376
91623194|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||ANCOVA|||Day 2||||0.0005
91623195|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||ANCOVA|||Day 2||||0.0026
91623196|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|||||||ANCOVA|||Day 4||||0.0007
91623197|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANCOVA|||Day 4||||0.0002
91623198|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387|||||||ANCOVA|||Day 7||||0.0387
91623199|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0059|||||||ANCOVA|||Day 7||||0.0059
91623200|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|||||||ANCOVA|||Day 14||||0.3110
91623201|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0613|||||||ANCOVA|||Day 14||||0.0613
91623202|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||ANCOVA|||Day 21||||0.0640
91623203|NCT00764478|183139396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139|||||||ANCOVA|||Day 21||||0.0139
91623204|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9708|||||||ANCOVA|||Day 2||||0.9708
91623205|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||ANCOVA|||Day 2||||0.7891
91623206|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5222|||||||ANCOVA|||Day 4||||0.5222
91623207|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8686|||||||ANCOVA|||Day 4||||0.8686
91623208|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|||||||ANCOVA|||Day 7||||0.0696
91623209|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||ANCOVA|||Day 7||||0.0049
91623210|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||ANCOVA|||Day 14||||0.0196
91623211|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0032|||||||ANCOVA|||Day 14||||0.0032
91623212|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||ANCOVA|||Day 21||||0.0061
91623213|NCT00764478|183139397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANCOVA|||Day 21||||0.0012
91623214|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0147
91623215|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0720
91481109|NCT01083173|182835456|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 24 weeks as compared to baseline||||< 0.0001
91481110|NCT01083173|182835456|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 48 weeks as compared to baseline||||< 0.0001
91623216|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1213|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1213
91623217|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0588|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0588
91623218|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0200
91623219|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0017
91623220|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2401|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2401
91623221|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0009
91623222|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0525|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0525
91623223|NCT00764478|183139398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0025
91623224|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0377|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0377
91623225|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0771|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0771
91623226|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1264|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1264
91623227|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0280
91623228|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0583|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0583
91623229|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0021
91623230|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0866
91623231|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0048|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0048
91623232|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0147
91623233|NCT00764478|183139399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0030
91623234|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0104
91623235|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0005
91481111|NCT04626310|182835464|SUPERIORITY||Linear slope difference DBT-ER-IP|0.096|STANDARD_ERROR_OF_MEAN|0.08||0.8|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.8
91481112|NCT04626310|182835464|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.234|STANDARD_ERROR_OF_MEAN|0.385||0.544|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.544
91481113|NCT04626310|182835464|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|0.329|STANDARD_ERROR_OF_MEAN|0.429||0.442|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.442
91623236|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0692
91623237|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0128
91623238|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0809|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0809
91623239|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0260
91623240|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2576|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2576
91623241|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0077
91623242|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.396|||||||Cochran-Mantel-Haenszel|||Day 21||||0.3960
91623243|NCT00764478|183139400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0141|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0141
91623244|NCT00764478|183139401|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0056|TWO_SIDED|95.0|-5.1|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.9|-5.1|0.0056
91623245|NCT00764478|183139401|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|1.08||0.0068|TWO_SIDED|95.0|-5.0|-0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.8|-5.0|0.0068
91623246|NCT00764478|183139401|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.33||0.0743|TWO_SIDED|95.0|-5.0|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-5.0|0.0743
91623247|NCT00764478|183139401|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.35||0.0177|TWO_SIDED|95.0|-5.9|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-5.9|0.0177
91623248|NCT00764478|183139401|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.41||0.0081|TWO_SIDED|95.0|-6.6|-1.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-1.0|-6.6|0.0081
91623249|NCT00764478|183139401|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.43||0.0247|TWO_SIDED|95.0|-6.1|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.4|-6.1|0.0247
91623250|NCT00764478|183139402|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9808|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-0.6|0.9808
91623251|NCT00764478|183139402|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.283|TWO_SIDED|95.0|-0.9|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-0.9|0.2830
91623252|NCT00764478|183139402|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9751|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.6|-0.6|0.9751
91623253|NCT00764478|183139402|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7879|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.7879
91623254|NCT00764478|183139402|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9654|TWO_SIDED|95.0|-0.8|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-0.8|0.9654
91623255|NCT00764478|183139402|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.39||0.3917|TWO_SIDED|95.0|-0.4|1.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.1|-0.4|0.3917
91623256|NCT00764478|183139403|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.012|TWO_SIDED|95.0|-1.8|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.8|0.0120
91623257|NCT00764478|183139403|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0011|TWO_SIDED|95.0|-2.2|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.5|-2.2|0.0011
91623258|NCT00764478|183139403|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6885|TWO_SIDED|95.0|-1.2|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.8|-1.2|0.6885
91623259|NCT00764478|183139403|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0398|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-2.1|0.0398
91623260|NCT00764478|183139403|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.51||0.0258|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.1|-2.1|0.0258
91623261|NCT00764478|183139403|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.5|STANDARD_ERROR_OF_MEAN|0.51||0.0031|TWO_SIDED|95.0|-2.5|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.5|-2.5|0.0031
91623262|NCT00764478|183139404|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.64||0.0033|TWO_SIDED|95.0|-3.2|-0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.6|-3.2|0.0033
91623263|NCT00764478|183139404|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.65||0.0622|TWO_SIDED|95.0|-2.5|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-2.5|0.0622
91623264|NCT00764478|183139404|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0083|TWO_SIDED|95.0|-3.6|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-3.6|0.0083
91623265|NCT00764478|183139404|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0064|TWO_SIDED|95.0|-3.8|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-3.8|0.0064
91623266|NCT00764478|183139404|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|0.84||0.0022|TWO_SIDED|95.0|-4.3|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.9|-4.3|0.0022
91623267|NCT00764478|183139404|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0196|TWO_SIDED|95.0|-3.7|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-3.7|0.0196
91623268|NCT00764478|183139405|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1883|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.1883
91623269|NCT00764478|183139405|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1684|TWO_SIDED|95.0|-1.3|0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.2|-1.3|0.1684
91623270|NCT00764478|183139405|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.9522|TWO_SIDED|95.0|-0.9|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.9|0.9522
91661272|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.162|TWO_SIDED|95.0|-0.018|0.108|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.108|-0.018|0.162
91481114|NCT04626310|182835465|SUPERIORITY||Linear slope difference DBT-ER-IP|1.951|STANDARD_ERROR_OF_MEAN|1.15||0.09|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.09
91623271|NCT00764478|183139405|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0514|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.0|-1.8|0.0514
91623272|NCT00764478|183139405|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0531|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.0|-1.8|0.0531
91623273|NCT00764478|183139405|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.48||0.0078|TWO_SIDED|95.0|-2.2|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-2.2|0.0078
91481115|NCT04626310|182835465|SUPERIORITY||Linear slope difference DBT-IE-IP|0.1|STANDARD_ERROR_OF_MEAN|1.228||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
91623274|NCT00764478|183139406|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7746|TWO_SIDED|95.0|-0.7|0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.5|-0.7|0.7746
91623275|NCT00764478|183139406|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2754|TWO_SIDED|95.0|-1.0|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-1.0|0.2754
91623276|NCT00764478|183139406|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.34||0.9109|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.9109
91623277|NCT00764478|183139406|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7295|TWO_SIDED|95.0|-0.6|0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.8|-0.6|0.7295
91623278|NCT00764478|183139406|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.98|TWO_SIDED|95.0|-0.7|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.8|-0.7|0.9800
91623279|NCT00764478|183139406|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.38||0.5122|TWO_SIDED|95.0|-0.5|1.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.0|-0.5|0.5122
91623280|NCT00764478|183139407|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2191|TWO_SIDED|95.0|-0.9|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.9|0.2191
91623281|NCT00764478|183139407|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0589|TWO_SIDED|95.0|-1.1|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.0|-1.1|0.0589
91661273|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.117|TWO_SIDED|95.0|-0.012|0.11|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.012|0.117
91623282|NCT00764478|183139407|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.3683|TWO_SIDED|95.0|-1.0|0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.0|0.3683
91623283|NCT00764478|183139407|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.37||0.0982|TWO_SIDED|95.0|-1.3|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.1|-1.3|0.0982
91623284|NCT00764478|183139407|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.1969|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.3|-1.3|0.1969
91623285|NCT00764478|183139407|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5615|TWO_SIDED|95.0|-1.0|0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||0.5|-1.0|0.5615
91623286|NCT00764478|183139408|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.33||0.0101|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0101
91623287|NCT00764478|183139408|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0146|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0146
91623288|NCT00764478|183139408|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0861|TWO_SIDED|95.0|-1.4|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-1.4|0.0861
91623289|NCT00764478|183139408|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0342|TWO_SIDED|95.0|-1.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-1.6|0.0342
91623290|NCT00764478|183139408|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0037|TWO_SIDED|95.0|-2.0|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.4|-2.0|0.0037
91623291|NCT00764478|183139408|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0096|TWO_SIDED|95.0|-1.9|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-1.9|0.0096
91623292|NCT00764478|183139409|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.32||0.0019|TWO_SIDED|95.0|-1.7|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.4|-1.7|0.0019
91623293|NCT00764478|183139409|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0791|TWO_SIDED|95.0|-1.2|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-1.2|0.0791
91623294|NCT00764478|183139409|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0006|TWO_SIDED|95.0|-2.0|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-2.0|0.0006
91623295|NCT00764478|183139409|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.37||0.0123|TWO_SIDED|95.0|-1.6|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.2|-1.6|0.0123
91623296|NCT00764478|183139409|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0054|TWO_SIDED|95.0|-2.0|-0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.3|-2.0|0.0054
91661274|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.02|TWO_SIDED|95.0|0.011|0.13|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.130|0.011|0.020
91623297|NCT00764478|183139409|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.035|TWO_SIDED|95.0|-1.7|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.1|-1.7|0.0350
91525083|NCT03324880|182925468|SUPERIORITY||Difference in LS Mean|10.5|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|5.1|15.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACIT-Fatigue total score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACIT-Fatigue total score.|15.9|5.1|<0.001
91525084|NCT03324880|182925469|SUPERIORITY||Difference in LS Mean|4.242|STANDARD_ERROR_OF_MEAN|1.9219|=|0.015|TWO_SIDED|95.0|0.413|8.072||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 PCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 PCS score.|8.072|0.413|=0.015
91623298|NCT00862121|183139410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.212||||0.231|TWO_SIDED|95.0|0.017|2.683|||Regression, Logistic|||The odds ratio (OR) for Baseline CDAI measures the effect of an increase of one unit on the outcome. The OR \[95% CI\] and p-value (likelihood-based) are for Pentasa versus placebo estimated in a logistic regression analysis including TREATMENT and CDAI at baseline as covariates. Power to demonstrate superiority of PENTASA Sachet 6 g/day over placebo in the primary efficacy analysis was 90% for a planned sample size of 255 participants per treatment arm (assuming 10% nonassessable participants).||2.683|0.017|0.231
91623299|NCT00092677|183139473|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.591||95.0|0.826|1.115|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.115|0.826|0.591
91623300|NCT00092677|183139474|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.973||||0.732||95.0|0.833|1.137|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.137|0.833|0.732
91623301|NCT00092677|183139475|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.024||95.0|0.628|0.967|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.967|0.628|0.024
91623302|NCT00092677|183139476|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.829||||0.344||95.0|0.563|1.222|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.222|0.563|0.344
91623303|NCT00092677|183139477|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.968||95.0|0.842|1.179|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.179|0.842|0.968
91713655|NCT00255164|183318826|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
91661275|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.909|TWO_SIDED|95.0|-0.062|0.07|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.062|0.909
91661276|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.419|TWO_SIDED|95.0|-0.037|0.088|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.088|-0.037|0.419
91661277|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.483|TWO_SIDED|95.0|-0.039|0.083|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.083|-0.039|0.483
91661278|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.126|TWO_SIDED|95.0|-0.012|0.099|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.099|-0.012|0.126
91661279|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.012|TWO_SIDED|95.0|0.017|0.131|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.131|0.017|0.012
91661280|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.037|TWO_SIDED|95.0|0.004|0.116|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.004|0.037
91661281|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|0.028|0.003
91661282|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.006|TWO_SIDED|95.0|0.021|0.127|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.127|0.021|0.006
91661283|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.282|TWO_SIDED|95.0|-0.025|0.087|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.025|0.282
91661284|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.554|TWO_SIDED|95.0|-0.039|0.072|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.072|-0.039|0.554
91661285|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.149|TWO_SIDED|95.0|-0.014|0.091|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.091|-0.014|0.149
91481116|NCT04626310|182835465|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|1.851|STANDARD_ERROR_OF_MEAN|1.103||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
91713656|NCT00255164|183318827|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91713657|NCT00255164|183318827|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91481117|NCT04626310|182835465|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
91661286|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.636|TWO_SIDED|95.0|-0.072|0.044|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.044|-0.072|0.636
91661287|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.775|TWO_SIDED|95.0|-0.047|0.063|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.063|-0.047|0.775
91661288|NCT03086460|183217296|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.425|TWO_SIDED|95.0|-0.032|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.032|0.425
91661289|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.058|0.187|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.187|0.058|<0.001
91661290|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.085|0.215|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.215|0.085|<0.001
91661291|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.059|0.189|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.059|<0.001
91481118|NCT04626310|182835465|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
91481119|NCT04626310|182835465|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
91623304|NCT00092677|183139478|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.088||||0.771||95.0|0.617|1.917|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.917|0.617|0.771
91623305|NCT00092677|183139479|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636||||0.147||95.0|0.345|1.173|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.173|0.345|0.147
91623306|NCT00092677|183139480|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.683||||0.015||95.0|0.503|0.929|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.929|0.503|0.015
91623307|NCT00092677|183139481|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.456||||||95.0|0.197|1.057||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.057|0.197|
91623308|NCT00092677|183139482|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.608||||||95.0|0.199|1.86||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.860|0.199|
91623309|NCT00092677|183139483|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.124||||0.647||95.0|0.682|1.85|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.850|0.682|0.647
91623310|NCT00092677|183139484|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.036||||0.799||95.0|0.788|1.363|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.363|0.788|0.799
91661292|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.001|TWO_SIDED|95.0|0.118|0.242|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.242|0.118|<0.001
91661293|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.177|||<|0.001|TWO_SIDED|95.0|0.115|0.238|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.115|<0.001
91661294|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.41|TWO_SIDED|95.0|-0.039|0.094|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.094|-0.039|0.410
91661295|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.961|TWO_SIDED|95.0|-0.063|0.066|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.063|0.961
91661296|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.07|TWO_SIDED|95.0|-0.005|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.005|0.070
91661297|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.454|TWO_SIDED|95.0|-0.095|0.043|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.043|-0.095|0.454
91661298|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.37|TWO_SIDED|95.0|-0.035|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.035|0.370
91713658|NCT00255164|183318827|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
91481120|NCT04626310|182835466|SUPERIORITY||Linear slope difference DBT-ER-IP|0.059|STANDARD_ERROR_OF_MEAN|0.083||0.475|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.475
91661299|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.086|TWO_SIDED|95.0|-0.008|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|-0.008|0.086
91661300|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.086||||0.011|TWO_SIDED|95.0|0.02|0.151|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.151|0.020|0.011
91713659|NCT02359110|183318837|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||Mixed Models Analysis|||Hour 2 Analysis||1.3|-1.2|0.89
91661301|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.005|TWO_SIDED|95.0|0.029|0.164|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.164|0.029|0.005
91713660|NCT02359110|183318837|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.6|1.5|||Mixed Models Analysis|||Hour 4 Analysis||1.5|-1.6|0.94
91713661|NCT02359110|183318837|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.64|TWO_SIDED|95.0|-2.2|1.3|||Mixed Models Analysis|||Hour 6 Analysis||1.3|-2.2|0.64
91623311|NCT00092677|183139485|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.667||||0.052||95.0|0.996|2.791|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.791|0.996|0.052
91623312|NCT00092677|183139486|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.504||||0.008||95.0|1.111|2.035|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.035|1.111|0.008
91623313|NCT00092677|183139487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.029||0.829||95.0|-0.063|0.051|||ANCOVA|Model terms: treatment and baseline peak transaortic jet velocity|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||0.051|-0.063|0.829
91623314|NCT00092677|183139488|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.1|STANDARD_ERROR_OF_MEAN|0.6|<=|0.001||95.0|-33.3|-31.0|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-31.0|-33.3|<=0.001
91623315|NCT00092677|183139489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|0.9|<=|0.001||95.0|-51.8|-48.2|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-48.2|-51.8|<=0.001
91623316|NCT00092677|183139490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.8|<=|0.001||95.0|2.4|5.5|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||5.5|2.4|<=0.001
91623317|NCT00092677|183139491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|1.3|<=|0.001||95.0|-22.6|-17.3|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-17.3|-22.6|<=0.001
91623318|NCT00873288|183139492|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||> 0.05
91713662|NCT02359110|183318837|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.59|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||Hour 8 Analysis||2.8|-1.6|0.59
91481121|NCT04626310|182835466|SUPERIORITY||Linear slope difference DBT-IE-IP|0.037|STANDARD_ERROR_OF_MEAN|0.082||0.654|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.654
91661302|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.021|0.010
91661303|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.208|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.081|<0.001
91661304|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.127|||<|0.001|TWO_SIDED|95.0|0.065|0.189|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.065|<0.001
91713663|NCT02359110|183318838|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.52|TWO_SIDED|95.0|-8.1|15.8|||Mixed Models Analysis|||Hour 2 Analysis||15.8|-8.1|0.52
91623319|NCT00873288|183139494|SUPERIORITY|||||||0.207|||||||Chi-squared|The Pearson Chi-squared value = 1.590||||||0.207
91623320|NCT00873288|183139495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91623321|NCT00010803|183139506|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.21|TWO_SIDED|95.0|0.94|1.33|||Log Rank|Time to dementia in Ginkgo vs placebo groups. The Cox proportional hazards model was used to compute hazard ratios and log-rank tests.||The null hypothesis is that the instantaneous hazard rate for Ginkgo biloba and placebo are the same. Assumptions were based on 4%/yr dementia and 6%/yr mortality and dropout combined. A sample size of 3000 with an average follow up of 5 years resulted in 96% power to detecting a 30% reduction in the rate of dementia at a 2-sided significance level of 0.5.||1.33|0.94|0.21
91623322|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.04||||0.7|TWO_SIDED|95.0|0.85|1.27|||Log Rank|||Total Mortality||1.27|0.85|0.70
91713664|NCT02359110|183318838|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.8|TWO_SIDED|95.0|-11.9|15.3|||Mixed Models Analysis|||Hour 6 Analysis||15.3|-11.9|0.80
91623323|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.06||||0.78|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||Atherosclerotic CHD mortality||1.62|0.70|0.78
91623324|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.54|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||Incident Myocardial Infarction||1.58|0.79|0.54
91661305|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.74|TWO_SIDED|95.0|-0.055|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.055|0.740
91713665|NCT02359110|183318839|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
91713666|NCT03934216|183318866|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5935|TWO_SIDED|95.0|0.3|2.4|||Stratified Cochran-Mantel-Haenszel|||||2.4|0.3|0.5935
91713667|NCT03934216|183318867|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3051|TWO_SIDED|95.0|0.6|2.7|||Stratified Cochran-Mantel-Haenszel|||||2.7|0.6|0.3051
91661306|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.973|TWO_SIDED|95.0|-0.064|0.066|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.064|0.973
91661307|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.064|TWO_SIDED|95.0|-0.003|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.003|0.064
91713668|NCT03934216|183318868|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8764|TWO_SIDED|95.0|0.3|1.4|||Stratified Cochran-Mantel-Haenszel|||||1.4|0.3|0.8764
91481122|NCT04626310|182835466|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|0.022|STANDARD_ERROR_OF_MEAN|0.085||0.791|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.791
91623325|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.84||||0.32|TWO_SIDED|95.0|0.61|1.18|||Log Rank|||Incident Angina||1.18|0.61|0.32
91623326|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.94||||0.66|TWO_SIDED|95.0|0.72|1.23|||Log Rank|||Incident CHD||1.23|0.72|0.66
91623327|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.91||||0.48|TWO_SIDED|95.0|0.71|1.18|||Log Rank|||Incident CHF||1.18|0.71|0.48
91623328|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident Stroke||1.45|0.52|0.25
91661308|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.774|TWO_SIDED|95.0|-0.079|0.059|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.059|-0.079|0.774
91661309|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.151|TWO_SIDED|95.0|-0.018|0.113|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.113|-0.018|0.151
91661310|NCT03086460|183217297|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.076|TWO_SIDED|95.0|-0.006|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.006|0.076
91661311|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.003|TWO_SIDED|95.0|0.039|0.19|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.190|0.039|0.003
91661312|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.055|0.206|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.206|0.055|<0.001
91661313|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.137|||<|0.001|TWO_SIDED|95.0|0.061|0.213|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.213|0.061|<0.001
91623329|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident TIA||1.45|0.52|0.59
91623330|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Cox Proportional Hazard|1.12||||0.42|TWO_SIDED|95.0|0.84|1.5|||Log Rank|||Incident CVD||1.50|0.84|0.42
91623331|NCT00010803|183139507|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.8|1.25|||Log Rank|||Total CHD and CVD combined||1.25|0.80|0.98
91623332|NCT00010803|183139508|SUPERIORITY_OR_OTHER||Treatment X Time interaction|-0.002||||0.65|TWO_SIDED|95.0|-0.009|0.005|||Mixed Models Analysis|||Linear mixed models comparing rates of change in global cognition scores (z-scores) by treatment group||0.005|-0.009|.65
91623333|NCT01878097|183139531|SUPERIORITY||F-stat|7.12||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
91623334|NCT01878097|183139532|SUPERIORITY||F-stat|7.18||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
91661314|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.078|0.223|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.078|<0.001
91661315|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.097|0.24|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.240|0.097|<0.001
91661316|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.679|TWO_SIDED|95.0|-0.061|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.061|0.679
91661317|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.549|TWO_SIDED|95.0|-0.052|0.098|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.098|-0.052|0.549
91661318|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.323|TWO_SIDED|95.0|-0.036|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.036|0.323
91713669|NCT03934216|183318869|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2235|TWO_SIDED|95.0|0.5|3.8|||Stratified Cochran-Mantel-Haenszel|||||3.8|0.5|0.2235
91713670|NCT00735709|183318870|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.93|||<|0.001|TWO_SIDED|95.0|-6.99|-2.86||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-2.86|-6.99|<0.001
91713671|NCT00735709|183318870|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.12|||<|0.001|TWO_SIDED|95.0|-6.17|-2.08||Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-2.08|-6.17|<0.001
91713672|NCT00735709|183318870|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.52|||<|0.001|TWO_SIDED|95.0|-5.57|-1.47||This treatment arm is not in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.47|-5.57|<0.001
91713673|NCT00735709|183318871|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.135|TWO_SIDED|95.0|-3.56|0.48||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.48|-3.56|0.135
91713674|NCT00735709|183318871|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.11||||0.263|TWO_SIDED|95.0|-3.07|0.84|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.84|-3.07|0.263
91713675|NCT00735709|183318871|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.963|TWO_SIDED|95.0|-2.03|1.94|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||1.94|-2.03|0.963
91713676|NCT00735709|183318872|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.30|-0.80|<0.001
91481123|NCT04626310|182835467|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.332|STANDARD_ERROR_OF_MEAN|0.095||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.001
91713677|NCT00735709|183318872|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.71|-0.22|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.22|-0.71|<0.001
91713678|NCT00735709|183318872|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.23|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.23|-0.72|<0.001
91713679|NCT00735709|183318873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.348|||<|0.001|TWO_SIDED|95.0|1.995|5.618|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo.|||5.618|1.995|<0.001
91713680|NCT00735709|183318873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.739|||<|0.001|TWO_SIDED|95.0|1.631|4.598|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||4.598|1.631|<0.001
91481124|NCT04626310|182835467|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.165|STANDARD_ERROR_OF_MEAN|0.094||0.078|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.078
91713681|NCT00735709|183318873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.018|||<|0.001|TWO_SIDED|95.0|1.799|5.063|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||5.063|1.799|<0.001
91713682|NCT00735709|183318874|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59||||0.001|TWO_SIDED|95.0|-7.34|-1.84|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.84|-7.34|0.001
91713683|NCT00735709|183318874|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.002|TWO_SIDED|95.0|-7.32|-1.62|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.62|-7.32|0.002
91623335|NCT04547998|183139535|SUPERIORITY|The difference in the proportion of responders (RECELL-Control) was tested for superiority of RECELL treatment (with a 10% superiority margin). For the null hypothesis to be rejected and super-superiority of RECELL to Control to be established, the lower limit of the 2-sided 95% CI of the difference in the proportion of responders (RECELL-Control) had to be greater than 10%.||||||0.012|||||||continuity-corrected method|Liu et al 2002||||||0.012
91481125|NCT04626310|182835467|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.167|STANDARD_ERROR_OF_MEAN|0.095||0.08|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.080
91713684|NCT00735709|183318874|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.13||||0.004|TWO_SIDED|95.0|-6.9|-1.37|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.37|-6.90|0.004
91713685|NCT00735709|183318875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.951||||0.026|TWO_SIDED|95.0|1.082|3.517|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.517|1.082|0.026
91713686|NCT00735709|183318875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.056||||0.015|TWO_SIDED|95.0|1.15|3.673|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.673|1.150|0.015
91713687|NCT00735709|183318875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.753||||0.062|TWO_SIDED|95.0|0.973|3.158|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.158|0.973|0.062
91713688|NCT00873730|183318924|SUPERIORITY_OR_OTHER|||||||0.6031|||||||Chi-squared|||||||0.6031
91713689|NCT00873730|183318925|SUPERIORITY_OR_OTHER|||||||0.9166|||||||Chi-squared|||||||0.9166
91713690|NCT00873730|183318926|SUPERIORITY_OR_OTHER|||||||0.7564|||||||Chi-squared|||||||0.7564
91713691|NCT00873730|183318927|SUPERIORITY_OR_OTHER|||||||0.3266|||||||Chi-squared|||||||0.3266
91713692|NCT00873730|183318928|SUPERIORITY_OR_OTHER|||||||0.7481|||||||Chi-squared|||||||0.7481
91713693|NCT00873730|183318929|SUPERIORITY_OR_OTHER|||||||0.7721|||||||Chi-squared|||||||0.7721
91481126|NCT04626310|182835468|SUPERIORITY||Linear Slope Diff DBT-ER-IP|0.091|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.13
91623336|NCT04547998|183139536|SUPERIORITY||||||<|0.001||||||P-value based on Wilcoxon signed rank test at 2-sided 0.05 significance level. The Wilcoxon signed rank test was based on the following repigmentation categories: 0% to 25%, 26% to 50%, 51% to 79%, and 80% to 100%.|Wilcoxon (Mann-Whitney)|||||||<0.001
91713694|NCT00873730|183318930|SUPERIORITY_OR_OTHER|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Nocturnal Back Pain.||||0.6660
91713695|NCT00873730|183318930|SUPERIORITY_OR_OTHER|||||||0.5364|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Overall Spinal Pain.||||0.5364
91623337|NCT04547998|183139537|SUPERIORITY|||||||1||||||2-sided (0.05 significance level), based on 19 participants with assessable color matching outcomes for both treatments|Wilcoxon (Mann-Whitney)|||||||1.000
91623338|NCT01595438|183139538|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
91623339|NCT01595438|183139539|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
91623340|NCT01595438|183139540|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
91623341|NCT01595438|183139541|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
91623342|NCT01595438|183139542|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
91623343|NCT01595438|183139543|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
91623344|NCT01595438|183139544|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
91623345|NCT01595438|183139545|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
91623346|NCT01595438|183139546|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
91623347|NCT01595438|183139547|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
91623348|NCT01595438|183139548|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
91713696|NCT00873730|183318931|SUPERIORITY_OR_OTHER|||||||0.9426|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Physician Global Assessment.||||0.9426
91713697|NCT00873730|183318931|SUPERIORITY_OR_OTHER|||||||0.4969|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Patient Global Assessment.||||0.4969
91713698|NCT00873730|183318932|SUPERIORITY_OR_OTHER|||||||0.6687|||||||Wilcoxon (Mann-Whitney)|||||||0.6687
91713699|NCT00873730|183318933|SUPERIORITY_OR_OTHER|||||||0.6739|||||||Wilcoxon (Mann-Whitney)|||||||0.6739
91713700|NCT00873730|183318934|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Wilcoxon (Mann-Whitney)|||||||0.2772
91713701|NCT00873730|183318935|SUPERIORITY_OR_OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.1560
91713702|NCT00873730|183318936|SUPERIORITY_OR_OTHER|||||||0.2099|||||||Chi-squared|||Analysis provided for Mobility.||||0.2099
91713703|NCT00873730|183318936|SUPERIORITY_OR_OTHER|||||||0.8009|||||||Chi-squared|||Analysis provided for Self-care.||||0.8009
91713704|NCT00873730|183318936|SUPERIORITY_OR_OTHER|||||||0.429|||||||Chi-squared|||Analysis provided for Usual activities.||||0.4290
91713705|NCT00873730|183318936|SUPERIORITY_OR_OTHER|||||||0.0461|||||||Chi-squared|||Analysis provided for Pain/Discomfort.||||0.0461
91713706|NCT00873730|183318936|SUPERIORITY_OR_OTHER|||||||0.562|||||||Chi-squared|||Analysis provided for Anxiety/Depression.||||0.5620
91713707|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.3476|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical functioning.||||0.3476
91713708|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.9045|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical role limitations.||||0.9045
91661319|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.866|TWO_SIDED|95.0|-0.073|0.087|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.073|0.866
91661320|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.596|TWO_SIDED|95.0|-0.055|0.096|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.055|0.596
91661321|NCT03086460|183217298|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Mean Difference (Final Values)|0.014||||0.72|TWO_SIDED|95.0|-0.061|0.088|||ANCOVA|||||0.088|-0.061|0.720
91661322|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.003|TWO_SIDED|95.0|0.038|0.185|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.185|0.038|0.003
91661323|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.209|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.209|0.057|<0.001
91481127|NCT04626310|182835468|SUPERIORITY||Linear slope difference DBT-IE-IP|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.046|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.046
91623349|NCT01595438|183139549|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
91661324|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.005|TWO_SIDED|95.0|0.032|0.18|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.180|0.032|0.005
91481128|NCT04626310|182835468|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.028|STANDARD_ERROR_OF_MEAN|0.057||0.617|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.617
91661325|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.081|0.223|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.081|<0.001
91661326|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.072|0.212|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.212|0.072|<0.001
91661327|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.573|TWO_SIDED|95.0|-0.053|0.096|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.053|0.573
91661328|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.881|TWO_SIDED|95.0|-0.078|0.067|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.067|-0.078|0.881
91623350|NCT01595438|183139550|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
91623351|NCT01595438|183139551|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
91661329|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.261|TWO_SIDED|95.0|-0.03|0.11|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.030|0.261
91661330|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.493|TWO_SIDED|95.0|-0.104|0.051|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.051|-0.104|0.493
91661331|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.616|TWO_SIDED|95.0|-0.055|0.092|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.092|-0.055|0.616
91661332|NCT03086460|183217298|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.212|TWO_SIDED|95.0|-0.026|0.118|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.118|-0.026|0.212
91661333|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.361|TWO_SIDED|95.0|-0.039|0.106|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.106|-0.039|0.361
91713709|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.8558|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Bodily pain.||||0.8558
91623352|NCT01595438|183139552|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
91623353|NCT01595438|183139553|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
91623354|NCT01595438|183139554|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
91623355|NCT01595438|183139555|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
91623356|NCT01595438|183139556|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
91623357|NCT01595438|183139557|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
91623358|NCT01595438|183139558|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
91623359|NCT01595438|183139559|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
91623360|NCT01595438|183139560|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
91623361|NCT01595438|183139561|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
91661334|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.065||||0.085|TWO_SIDED|95.0|-0.009|0.138|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.138|-0.009|0.085
91661335|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.328|TWO_SIDED|95.0|-0.037|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.037|0.328
91713710|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.3123|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for General health.||||0.3123
91713711|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.3327|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Vitality.||||0.3327
91623362|NCT01595438|183139562|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
91623363|NCT01595438|183139563|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
91623364|NCT01595438|183139564|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
91623365|NCT01595438|183139565|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
91623366|NCT01595438|183139566|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
91623367|NCT01595438|183139567|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
91623368|NCT01595438|183139568|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
91623369|NCT01595438|183139569|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
91713712|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.8334|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Social functioning.||||0.8334
91623370|NCT01595438|183139570|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
91623371|NCT00291499|183139621|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.016
91623372|NCT00291499|183139622|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
91623373|NCT00291499|183139623|SUPERIORITY|||||||0.043||||||Threshold p \<0.05|Cochran-Mantel-Haenszel|||||||0.043
91623374|NCT00291499|183139624|SUPERIORITY|||||||0.132||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.132
91623375|NCT00291499|183139625|SUPERIORITY|||||||0.031||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.031
91661336|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.002|TWO_SIDED|95.0|0.042|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.042|0.002
91481129|NCT04626310|182835469|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.29|STANDARD_ERROR_OF_MEAN|0.103||0.005|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.005
91481130|NCT04626310|182835469|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.111|STANDARD_ERROR_OF_MEAN|0.103||0.281|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.281
91481131|NCT04626310|182835469|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.18|STANDARD_ERROR_OF_MEAN|0.098||0.066|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.066
91481132|NCT04626310|182835470|SUPERIORITY||Linear slope difference DBT-ER-IP|1.049|STANDARD_ERROR_OF_MEAN|0.653||0.108|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.108
91481133|NCT04626310|182835470|SUPERIORITY||Linear slope difference DBT-IE-IP|-1.21|STANDARD_ERROR_OF_MEAN|0.454||0.014|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.014
91481134|NCT04626310|182835470|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|2.17|STANDARD_ERROR_OF_MEAN|0.631||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.001
91481135|NCT04626310|182835471|OTHER||Linear Slope difference DBT-ER-IP|0.17|STANDARD_ERROR_OF_MEAN|0.136||0.211|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.211
91481136|NCT04626310|182835471|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.195|STANDARD_ERROR_OF_MEAN|0.135||0.148|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.148
91481137|NCT04626310|182835471|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|-0.025|STANDARD_ERROR_OF_MEAN|0.137||0.857|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.857
91481138|NCT04626310|182835472|SUPERIORITY||Linear Slope Difference in DSS DBT-ER-IP|-0.313|STANDARD_ERROR_OF_MEAN|0.794||0.693|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.693
91481139|NCT04626310|182835472|SUPERIORITY||Linear Slope Difference in DSS DBT-IE-IP|0.002|STANDARD_ERROR_OF_MEAN|0.767||0.998|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.998
91481140|NCT04626310|182835472|SUPERIORITY||Linear Slope Diff in DSS DBT-ER-DBT-IE|-0.315|STANDARD_ERROR_OF_MEAN|0.765||0.68|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.680
91481141|NCT04626310|182835472|SUPERIORITY||Linear Slope Difference in DC1 DBT-ER-IP|0.098|STANDARD_ERROR_OF_MEAN|0.101||0.333|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.333
91481142|NCT04626310|182835472|SUPERIORITY||Linear Slope Diff in DC1 DBT-IE-IP|-0.046|STANDARD_ERROR_OF_MEAN|0.097||0.632|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.632
91623376|NCT00291499|183139626|SUPERIORITY||Mean Difference (Final Values)|0.363|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91661337|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.089||||0.011|TWO_SIDED|95.0|0.02|0.158|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.158|0.020|0.011
91661338|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.404|TWO_SIDED|95.0|-0.042|0.104|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.104|-0.042|0.404
91713713|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.7998|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Emotional role limitations.||||0.7998
91623377|NCT04426890|183139639|EQUIVALENCE|Therapeutic equivalence was declared if the two-sided 90% confidence interval (CI) for the treatment difference was entirely within an equivalence margin of \[-2.5, 2.0\].|Mean Difference (Net)|0.7|||||TWO_SIDED|90.0|-0.22|1.63||||||The statistical analysis of mean change from baseline in ISS7 at Week 12 between CT-P39 300 mg treatment arm (Arm 1) and Xolair 300 mg treatment arm (Arm 2), using ANCOVA with multiple imputation based on the MAR assumption was performed for the mITT Set.||1.63|-0.22|
91623378|NCT01457924|183139662|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||Note: There is a discrepancy in the number of par. in ITT populations at Wk 24 and Wk 48: 228 and 229 respectively. This resulted from a data issue: one par was incorrectly excluded from ITT pop. at Wk 24, but correctly included in Wk 48. This error affects all source tables, analyses relating to ITT and per protocol populations, primary endpoint and secondary MRI endpoints reported at Wk 24. This discrepancy affects all statistical analyses, but not summary statistics.||0.548|0.221|<0.001
91623379|NCT01457924|183139662|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
91623380|NCT01457924|183139662|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
91623381|NCT01457924|183139662|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
91623382|NCT01457924|183139663|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
91623383|NCT01457924|183139663|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
91623384|NCT01457924|183139663|SUPERIORITY_OR_OTHER||Ratio|0.35||||0.001|TWO_SIDED|95.0|0.19|0.65|||Generalized Linear Model|||||0.65|0.19|0.001
91623385|NCT01457924|183139663|SUPERIORITY_OR_OTHER||Ratio|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.39|||Generalized Linear Model|||||0.39|0.13|<0.001
91623386|NCT01457924|183139666|SUPERIORITY_OR_OTHER||Ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.16|0.6|||Generalized Linear Model|||||0.60|0.16|<0.001
91623387|NCT01457924|183139666|SUPERIORITY_OR_OTHER||Ratio|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Generalized Linear Model|||||1.06|0.29|0.075
91623388|NCT01457924|183139666|SUPERIORITY_OR_OTHER||Ratio|0.51||||0.035|TWO_SIDED|95.0|0.27|0.95|||Generalized Linear Model|||||0.95|0.27|0.035
91623389|NCT01457924|183139666|SUPERIORITY_OR_OTHER||Ratio|0.32|||<|0.001|TWO_SIDED|95.0|0.19|0.55|||Generalized Linear Model|||||0.55|0.19|<0.001
91623390|NCT01457924|183139667|SUPERIORITY_OR_OTHER||Ratio|0.22||||0.026|TWO_SIDED|95.0|0.06|0.84|||Generalized Linear Model|||||0.84|0.06|0.026
91623391|NCT01457924|183139667|SUPERIORITY_OR_OTHER||Ratio|0.49||||0.296|TWO_SIDED|95.0|0.13|1.86|||Generalized Linear Model|||||1.86|0.13|0.296
91623392|NCT01457924|183139667|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.285|TWO_SIDED|95.0|0.14|1.78|||Generalized Linear Model|||||1.78|0.14|0.285
91623393|NCT01457924|183139667|SUPERIORITY_OR_OTHER||Ratio|0.25||||0.009|TWO_SIDED|95.0|0.09|0.71|||Non-Linear Emax Model|||||0.71|0.09|0.009
91623394|NCT01457924|183139668|SUPERIORITY_OR_OTHER||Ratio|0.18||||0.004|TWO_SIDED|95.0|0.05|0.58|||Generalized Linear Model|||||0.58|0.05|0.004
91623395|NCT01457924|183139668|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.248|TWO_SIDED|95.0|0.15|1.63|||Generalized Linear Model|||||1.63|0.15|0.248
91623396|NCT01457924|183139668|SUPERIORITY_OR_OTHER||Ratio|0.46||||0.181|TWO_SIDED|95.0|0.15|1.43|||Generalized Linear Model|||||1.43|0.15|0.181
91623397|NCT01457924|183139668|SUPERIORITY_OR_OTHER||Ratio|0.24||||0.003|TWO_SIDED|95.0|0.1|0.62|||Generalized Linear Model|||||0.62|0.10|0.003
91623398|NCT01457924|183139669|SUPERIORITY_OR_OTHER||Ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.58|||Generalized Linear Model|||||0.58|0.15|<0.001
91623399|NCT01457924|183139669|SUPERIORITY_OR_OTHER||Ratio|0.34||||0.002|TWO_SIDED|95.0|0.17|0.68|||Generalized Linear Model|||||0.68|0.17|0.002
91623400|NCT01457924|183139669|SUPERIORITY_OR_OTHER||Ratio|0.4||||0.006|TWO_SIDED|95.0|0.21|0.77|||Generalized Linear Model|||||0.77|0.21|0.006
91623401|NCT01457924|183139669|SUPERIORITY_OR_OTHER||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.35|||Generalized Linear Model|||||0.35|0.11|<0.001
91623402|NCT02855450|183139674|SUPERIORITY||Least square means difference|4.7||||0.04|TWO_SIDED|95.0|0.2|9.2|||ANCOVA|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.||These statistics refer to Day 7 and primary eye||9.2|0.2|0.040
91623403|NCT02855450|183139674|SUPERIORITY||least square mean difference|2.4||||0.457|TWO_SIDED|95.0|-4.1|9.0||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 28 and primary eye||9.0|-4.1|0.457
91623404|NCT02855450|183139674|SUPERIORITY||least square mean difference|4.0||||0.283|TWO_SIDED|95.0|-3.5|11.5||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 56 and primary eye||11.5|-3.5|0.283
91623405|NCT02855450|183139674|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|Least square means difference|3.5||||0.147|TWO_SIDED|95.0|-1.3|8.3|||ANCOVA|||These statistics refer to Day 7 and secondary eye||8.3|-1.3|0.147
91623406|NCT02855450|183139674|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|3.0||||0.421|TWO_SIDED|95.0|-4.4|10.4|||ANCOVA|||These statistics refer to Day 28 and secondary eye||10.4|-4.4|0.421
91661339|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.942|TWO_SIDED|95.0|-0.069|0.074|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.069|0.942
91713714|NCT00873730|183318937|SUPERIORITY_OR_OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Mental health.||||0.7125
91713715|NCT00873730|183318939|SUPERIORITY_OR_OTHER|||||||0.7404|||||||Wilcoxon (Mann-Whitney)|||||||0.7404
91661340|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.027|TWO_SIDED|95.0|0.009|0.147|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.147|0.009|0.027
91661341|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.463|TWO_SIDED|95.0|-0.104|0.048|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.048|-0.104|0.463
91623407|NCT02855450|183139674|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|4.3||||0.327|TWO_SIDED|95.0|-4.4|13.0|||ANCOVA|||These statistics refer to Day 56 and secondary eye||13.0|-4.4|0.327
91623408|NCT05053126|183139693|SUPERIORITY||Mean Difference (Final Values)|36.83|STANDARD_ERROR_OF_MEAN|3.132|<|0.0001|ONE_SIDED|95.0|31.65||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||31.65|<0.0001
91623409|NCT05053126|183139693|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.49||0.2469|ONE_SIDED|95.0||3.4|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||3.4||0.2469
91661342|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.2|TWO_SIDED|95.0|-0.025|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.025|0.200
91661343|NCT03086460|183217299|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.037|TWO_SIDED|95.0|0.005|0.146|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.146|0.005|0.037
91661344|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.896|TWO_SIDED|95.0|-0.083|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.073|-0.083|0.896
91661345|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.81|TWO_SIDED|95.0|-0.089|0.07|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.089|0.810
91661346|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.882|TWO_SIDED|95.0|-0.084|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.073|-0.084|0.882
91713716|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|1.00|
91661347|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.115|TWO_SIDED|95.0|-0.015|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|-0.015|0.115
91661348|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.111|TWO_SIDED|95.0|-0.014|0.134|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.134|-0.014|0.111
91661349|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.911|TWO_SIDED|95.0|-0.083|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.083|0.911
91661350|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|-0.001||||0.985|TWO_SIDED|95.0|-0.078|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.078|0.985
91661351|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.084|TWO_SIDED|95.0|-0.009|0.14|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.140|-0.009|0.084
91661352|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.928|TWO_SIDED|95.0|-0.078|0.086|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.078|0.928
91661353|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.078|TWO_SIDED|95.0|-0.008|0.148|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.148|-0.008|0.078
91661354|NCT03086460|183217300|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.089|TWO_SIDED|95.0|-0.01|0.143|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.143|-0.010|0.089
91713717|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.01|0.99|
91713718|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|0.99|
91661355|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|18.01|||<|0.001|TWO_SIDED|95.0|4.25|76.37|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Time to onset of action was analyzed using a Cox proportional hazard model stratified by patient, including treatment and period as a factor, and baseline FEV1 as covariate.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment."||76.37|4.25|<0.001
91661356|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|31.67|||<|0.001|TWO_SIDED|95.0|7.52|133.47|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||133.47|7.52|<0.001
91661357|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|44.24|||<|0.001|TWO_SIDED|95.0|10.23|191.34|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||191.34|10.23|<0.001
91481143|NCT04626310|182835472|SUPERIORITY||Linear Slope Diff in DC1 DBT-ER-DBT-IE|0.144|STANDARD_ERROR_OF_MEAN|0.107||0.178|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to DBT-ER.||||.178
91481144|NCT04626310|182835472|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-IP|0.045|STANDARD_ERROR_OF_MEAN|0.112||0.689|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to IP.||||.689
91481145|NCT04626310|182835472|SUPERIORITY||Linear Slope Diff in DC2 DBT-IE-IP|-0.011|STANDARD_ERROR_OF_MEAN|0.109||0.917|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-IE to IP.||||.917
91481146|NCT04626310|182835472|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-DBT-IE|0.056|STANDARD_ERROR_OF_MEAN|0.108||0.603|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to DBT-IE.||||.603
91623410|NCT05053126|183139693|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.48||0.1756|ONE_SIDED|95.0||2.5|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||2.5||0.1756
91623411|NCT05053126|183139693|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.84||0.0001|ONE_SIDED|95.0||4.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||4.3||0.0001
91661358|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|40.32|||<|0.001|TWO_SIDED|95.0|9.54|170.45|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||170.45|9.54|<0.001
91661359|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|22.91|||<|0.001|TWO_SIDED|95.0|5.7|92.06|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||92.06|5.70|<0.001
91713719|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.04|1.00|
91481147|NCT04626310|182835473|SUPERIORITY||Other[Quad Slope difference DBT-ER-IP]|0.013|STANDARD_ERROR_OF_MEAN|0.044||0.762|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.762
91481148|NCT04626310|182835473|SUPERIORITY||Quad Slope difference DBT-IE-IP|0.034|STANDARD_ERROR_OF_MEAN|0.047||0.478|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.478
91481149|NCT04626310|182835473|SUPERIORITY||Quad Slope difference DBT-ER-DBT-IE|-0.089|STANDARD_ERROR_OF_MEAN|0.054||0.705|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.705
91661360|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.195|TWO_SIDED|95.0|0.75|4.13|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.13|0.75|0.195
91661361|NCT03086460|183217301|SUPERIORITY||Risk Ratio (RR)|2.46||||0.037|TWO_SIDED|95.0|1.06|5.72|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||5.72|1.06|0.037
91661362|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.042|TWO_SIDED|95.0|1.03|4.86|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.86|1.03|0.042
91713720|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.98|
91713721|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|0.95|0.97|1.02|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.02|0.97|
91661363|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.435|TWO_SIDED|95.0|0.6|3.23|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||3.23|0.60|0.435
91481150|NCT04626310|182835474|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
91481151|NCT04626310|182835474|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
91481152|NCT04626310|182835474|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
91481153|NCT04626310|182835475|SUPERIORITY||Quad slope diff in DC1 DBT-ER-IP|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.313|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to IP.||||.313
91481154|NCT04626310|182835475|SUPERIORITY||Quad Slope in DC1 DBT-IE-IP|0.003|STANDARD_ERROR_OF_MEAN|0.01||0.747|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-IE to IP.||||.747
91481155|NCT04626310|182835475|SUPERIORITY||Quad slope diff in DC1 DBT-ER-DBT-IE|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.444|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to DBT-IE.||||.444
91623412|NCT05053126|183139693|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.84||0.0099|ONE_SIDED|95.0||8.0|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||8.0||0.0099
91623413|NCT05053126|183139693|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|18.2|STANDARD_ERROR_OF_MEAN|3.13||0.9888|ONE_SIDED|95.0||23.4|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||23.4||0.9888
91481156|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0081||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to post intervention||||0.0081
91481157|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0243||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to post intervention||||0.0243
91481158|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.071||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to post intervention||||0.0710
91713722|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.97|
91481159|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0008||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to post intervention||||0.0008
91481160|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1094||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to one-month follow-up||||0.1094
91481161|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2029||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to one-month follow-up||||0.2029
91623414|NCT05053126|183139693|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|3.13||0.9997|ONE_SIDED|95.0||27.1|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||27.1||0.9997
91623415|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|75.6|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|65.79|85.42|||Mixed Models Analysis|||||85.42|65.79|<0.0001
91661364|NCT03086460|183217301|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.564|TWO_SIDED|95.0|0.56|2.89|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||2.89|0.56|0.564
91713723|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.05|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.05|0.98|
91481162|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8599||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to one-month follow-up||||0.8599
91481163|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0007||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to one-month follow-up||||0.0007
91623416|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|44.84|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|35.03|54.65|||Mixed Models Analysis|||||54.65|35.03|<0.0001
91623417|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|49.93|STANDARD_ERROR_OF_MEAN|5.945|<|0.0001|TWO_SIDED|90.0|40.12|59.75|||Mixed Models Analysis|||||59.75|40.12|<0.0001
91623418|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|80.8|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|70.99|90.61|||Mixed Models Analysis|||||90.61|70.99|<0.0001
91623419|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|81.91|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|72.09|91.73|||Mixed Models Analysis|||||91.73|72.09|<0.0001
91623420|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|-30.8|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|-40.6|-20.9|||Mixed Models Analysis|||||-20.9|-40.6|<0.0001
91623421|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|-35.5|-15.9|||Mixed Models Analysis|||||-15.9|-35.5|<0.0001
91481164|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0246||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from post-intervention to one-month follow-up||||0.0246
91623422|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.945||0.3829|TWO_SIDED|90.0|-4.62|15.01|||Mixed Models Analysis|||||15.01|-4.62|0.3829
91623423|NCT05053126|183139694|OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|5.942||0.2896|TWO_SIDED|90.0|-3.5|16.11|||Mixed Models Analysis|||||16.11|-3.50|0.2896
91623424|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|23.47|STANDARD_ERROR_OF_MEAN|2.247|<|0.0001|TWO_SIDED|90.0|19.77|27.17|||Mixed Models Analysis|||||27.17|19.77|<0.0001
91481165|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.078||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from post-intervention to one-month follow-up||||0.0780
91623425|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|6.71|14.09|||Mixed Models Analysis|||||14.09|6.71|<0.0001
91623426|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|11.29|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|90.0|7.59|14.99|||Mixed Models Analysis|||||14.99|7.59|<0.0001
91623427|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|24.33|STANDARD_ERROR_OF_MEAN|2.251|<|0.0001|TWO_SIDED|90.0|20.62|28.03|||Mixed Models Analysis|||||28.03|20.62|<0.0001
91623428|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|22.34|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|18.65|26.04|||Mixed Models Analysis|||||26.04|18.65|<0.0001
91623429|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|-16.8|-9.38|||Mixed Models Analysis|||||-9.38|-16.8|<0.0001
91661365|NCT03086460|183217301|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Hazard Ratio (HR)|0.91||||0.818|TWO_SIDED|95.0|0.41|2.01|||Regression, Cox|||||2.01|0.41|0.818
91623430|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.252|<|0.0001|TWO_SIDED|90.0|-15.9|-8.47|||Mixed Models Analysis|||||-8.47|-15.9|<0.0001
91623431|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|2.258||0.7051|TWO_SIDED|90.0|-2.86|4.57|||Mixed Models Analysis|||||4.57|-2.86|0.7051
91623432|NCT05053126|183139695|OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|2.246||0.616|TWO_SIDED|90.0|-4.82|2.57|||Mixed Models Analysis|||||2.57|-4.82|0.6160
91623433|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|21.99|STANDARD_ERROR_OF_MEAN|2.235|<|0.0001|TWO_SIDED|90.0|18.31|25.67|||Mixed Models Analysis|||||25.67|18.31|<0.0001
91623434|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.227||0.0042|TWO_SIDED|90.0|2.73|10.07|||Mixed Models Analysis|||||10.07|2.73|0.0042
91623435|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|2.236|<|0.0001|TWO_SIDED|90.0|6.12|13.48|||Mixed Models Analysis|||||13.48|6.12|<0.0001
91623436|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|21.12|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|17.44|24.81|||Mixed Models Analysis|||||24.81|17.44|<0.0001
91623437|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|21.27|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|17.59|24.95|||Mixed Models Analysis|||||24.95|17.59|<0.0001
91623438|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|-19.3|-11.9|||Mixed Models Analysis|||||-11.9|-19.3|<0.0001
91623439|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|-15.9|-8.5|||Mixed Models Analysis|||||-8.50|-15.9|<0.0001
91623440|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.246||0.7001|TWO_SIDED|90.0|-4.56|2.83|||Mixed Models Analysis|||||2.83|-4.56|0.7001
91623441|NCT05053126|183139696|OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|2.233||0.7479|TWO_SIDED|90.0|-4.4|2.96|||Mixed Models Analysis|||||2.96|-4.40|0.7479
91623442|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|27.82|STANDARD_ERROR_OF_MEAN|1.439|<|0.0001|TWO_SIDED|90.0|25.45|30.19|||Mixed Models Analysis|||||30.19|25.45|<0.0001
91661366|NCT02545283|183217313|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5752|TWO_SIDED|95.0|0.81|1.45|||Log Rank|||||1.45|0.81|0.5752
91661367|NCT00583453|183217377|SUPERIORITY_OR_OTHER|||||||0.674||||||Treatment x day interaction|Wilcoxon (Mann-Whitney)|||||||.674
91661368|NCT00583453|183217378|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment x day interaction reported as 0.018.|Wilcoxon (Mann-Whitney)|||||||0.018
91661369|NCT00583453|183217379|SUPERIORITY_OR_OTHER|||||||0.214||||||Treatment x day interaction = 0.214|Wilcoxon (Mann-Whitney)|||||||.214
91481166|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0167||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from post-intervention to one-month follow-up||||0.0167
91623443|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|14.53|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|12.17|16.89|||Mixed Models Analysis|||||16.89|12.17|<0.0001
91623444|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|17.85|STANDARD_ERROR_OF_MEAN|1.437|<|0.0001|TWO_SIDED|90.0|15.49|20.22|||Mixed Models Analysis|||||20.22|15.49|<0.0001
91623445|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|34.4|STANDARD_ERROR_OF_MEAN|1.438|<|0.0001|TWO_SIDED|90.0|34.4|36.77|||Mixed Models Analysis|||||36.77|34.40|<0.0001
91623446|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|38.84|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|90.0|36.47|41.21|||Mixed Models Analysis|||||41.21|36.47|<0.0001
91623447|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|-13.3|STANDARD_ERROR_OF_MEAN|1.434|<|0.0001|TWO_SIDED|90.0|-15.6|-10.9|||Mixed Models Analysis|||||-10.9|-15.6|<0.0001
91623448|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|-9.97|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|-12.3|-7.61|||Mixed Models Analysis|||||-7.61|-12.3|<0.0001
91623449|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|4.22|8.94|||Mixed Models Analysis|||||8.94|4.22|<0.0001
91623450|NCT05053126|183139697|OTHER||Mean Difference (Final Values)|11.02|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|8.65|13.38|||Mixed Models Analysis|||||13.38|8.65|<0.0001
91623451|NCT04024072|183139698|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-0.93|0.01||||||||0.01|-0.93|
91623452|NCT04024072|183139698|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.7|0.24||||||||0.24|-0.70|
91623453|NCT04024072|183139698|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.74|0.27||||||||0.27|-0.74|
91623454|NCT04024072|183139698|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.51|0.51||||||||0.51|-0.51|
91623455|NCT01376245|183139718|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|||<|0.001|TWO_SIDED|95.0|0.089|0.191|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.191|0.089|<0.001
91623456|NCT01376245|183139718|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.179|||<|0.001|TWO_SIDED|95.0|0.129|0.23|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.230|0.129|<0.001
91623457|NCT01376245|183139718|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.194|||<|0.001|TWO_SIDED|95.0|0.143|0.245|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.245|0.143|<0.001
91623458|NCT01357889|183139736|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.937|||||TWO_SIDED|90.0|0.842|1.042|||ANOVA|||||1.042|0.842|
91623459|NCT01357889|183139737|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.927|||||TWO_SIDED|90.0|0.813|1.056|||ANOVA|||||1.056|0.813|
91623460|NCT01170221|183139750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|0.1||||||95.0|-6.1|6.2|||||Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.||6.2|-6.1|
91661370|NCT00583453|183217381|SUPERIORITY_OR_OTHER|||||||0.036||||||treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003|Wilcoxon (Mann-Whitney)|||||||0.036
91661371|NCT00905606|183217382|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|93.91||||||90.0|85.42|103.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.25|85.42|
91661372|NCT00905606|183217383|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.27||||||90.0|94.63|102.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.05|94.63|
91661373|NCT00905606|183217384|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.19||||||90.0|94.64|101.87|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.87|94.64|
91661374|NCT02659150|183217395|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.24||0.26|TWO_SIDED||||||t-test, 2 sided|||Paired T-test comparing values obtained during the follow-up imaging (at 13-18 weeks)minus the baseline values||||0.26
91661375|NCT02659150|183217396|OTHER||Spearman Correlation Coefficient|0.76||||0.036|TWO_SIDED||||||Spearman|||correlation coefficient||||0.036
91661376|NCT02659150|183217397|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.32||0.14|TWO_SIDED||||||t-test, 2 sided|||The carotid artery plaque with highest FDG uptake is located using Positron Emission Tomography/ Magnetic Resonance Imaging images. Thereafter Paired T- Test is used to compare baseline vs follow-up values of FDG uptake (before vs after 12 weeks of tocilizumab treatment). FDG uptake is assessed as a Target to background values (TBR) , which is calculated as the mean arterial standardized uptake value (SUV) divided by background blood pool SUV.||||0.14
91661377|NCT02659150|183217398|SUPERIORITY||correlation coefficient|-0.66||||0.076|TWO_SIDED||||||Spearman's Method|||||||0.076
91661378|NCT02659150|183217399|SUPERIORITY||Correlation coefficient|0.67||||0.07|TWO_SIDED||||||Spearman's Method|||||||0.07
91661379|NCT01363765|183217432|SUPERIORITY_OR_OTHER||notification rate ratio|1.59|||<|0.01|TWO_SIDED|95.0|1.32|1.87||NR were calculated using an aggregated database consisting of 896 strata for laboratory (n=14), study month (n=8), sex (n=2) and age group (n=4: \<15, 15-39, 40-59, and \>=60 years). Poisson regression modeling was used to analyze changes in TB TB NR|Clustered Avareged|Adjustment for municipality, age, sex, and baseline proportion of samples with a positive smear was by a population-averaged quasi-likelihood approach|"The numbers reported in the CONSORT flowchart refer to the diagnostic samples. NR were obtained crosslinking lab and notification databases, denominator was population/year."|cluster-averaged NNR=1.59 (CI95% 1.31-1.88) Absolute numbers informed in table do not allow calculation of notification rates; they are based on population size, not in total numbers and percentages||1.87|1.32|<0.01
91661380|NCT01363765|183217432|SUPERIORITY_OR_OTHER||notification rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.51|1.92|||Mixed Models Analysis|Mixed multi-level model, time-adjusted||Secondary analysis: Mixed multi-level model||1.92|1.51|<0.001
91661381|NCT01363765|183217433|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|-84.07||||||95.0||||||Incremental cost-effectiveness ratio (ICER) per case detected||||||
91661382|NCT01363765|183217434|SUPERIORITY_OR_OTHER||NRR|0.98||||0.923|TWO_SIDED|95.0|0.64|1.32||cluster-averaged adjusted NRR (notification rate ratio, not calculable from number shown, which are a proportion of tests. NRR calculated over a population/year denominator.|Agregated cluster-averaged|||||1.32|0.64|0.923
91661383|NCT01363765|183217435|SUPERIORITY_OR_OTHER||NRR|0.52||||0.004|TWO_SIDED|95.0|0.21|0.84||cluster-averaged adjusted NRR|Agregated cluster-averaged|||||0.84|0.21|0.004
91661384|NCT00609674|183217438|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||||||0.004
91661385|NCT00571064|183217461|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.6593
91713724|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.99|
91481167|NCT03239665|182835476|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.9417||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from post-intervention to one-month follow-up||||0.9417
91661386|NCT00571064|183217461|SUPERIORITY_OR_OTHER|||||||0.6048|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.6048
91661387|NCT00571064|183217461|SUPERIORITY_OR_OTHER|||||||0.5924|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.5924
91661388|NCT00571064|183217462|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||<0.0001
91661389|NCT00571064|183217462|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||<0.0001
91661390|NCT00571064|183217462|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||<0.0001
91661391|NCT00571064|183217464|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.0431
91661392|NCT00571064|183217464|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.0431
91661393|NCT00571064|183217466|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.1285
91661394|NCT00571064|183217466|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.1285
91661395|NCT00571064|183217468|SUPERIORITY_OR_OTHER|||||||0.2327|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.2327
91661396|NCT00571064|183217468|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.4724
91661397|NCT00571064|183217468|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF - Study Endpoint||||0.4724
91661398|NCT02363803|183217470|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired t-test||||||0.03
91661399|NCT03140631|183217475|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91661400|NCT03140631|183217476|SUPERIORITY|||||||0.74|||||||Fisher Exact|||number of participants who experienced a vascular access site complication at 90 days||||0.74
91661401|NCT02169115|183217477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.7||0.05|TWO_SIDED||||||ANOVA|||||||0.05
91661402|NCT02169115|183217477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|1.8||0.005|TWO_SIDED||||||ANOVA|||||||0.005
91661403|NCT02169115|183217477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|1.4|||TWO_SIDED|||||||||||||
91661404|NCT03872128|183217505|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
91661405|NCT03872128|183217506|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
91661406|NCT03872128|183217507|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
91661407|NCT03872128|183217508|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Total||||<0.001
91661408|NCT03872128|183217508|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Obsessive||||<0.001
91661409|NCT03872128|183217508|SUPERIORITY|||||||0.003|||||||Fisher Exact|||OCDS: Compulsive||||0.003
91661410|NCT03872128|183217510|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
91661411|NCT03872128|183217511|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||HADS-Depression||||<0.001
91661412|NCT03872128|183217511|SUPERIORITY|||||||0.089|||||||Fisher Exact|||HADS-Anxiety||||0.089
91661413|NCT03285594|183217516|SUPERIORITY||Difference in Least Square (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.638|-0.271|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.271|-0.638|<0.0001
91661414|NCT03285594|183217516|SUPERIORITY||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.706|-0.387|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.387|-0.706|<0.0001
91481168|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0011||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||0.0011
91623461|NCT01170221|183139751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI will be calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-9.6|4.2||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.2|-9.6|
91623462|NCT01170221|183139752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-7.7|5.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||5.4|-7.7|
91623463|NCT01170221|183139753|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-5.8|4.9|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||4.9|-5.8|
91623464|NCT01170221|183139754|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||3.0|-4.6|
91623465|NCT01170221|183139755|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.4|8.5|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||8.5|-1.4|
91661415|NCT03285594|183217517|SUPERIORITY||Difference in LS Means|-15.858|STANDARD_ERROR_OF_MEAN|4.6056||0.0006|TWO_SIDED|95.0|-24.8845|-6.8309|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-6.8309|-24.8845|0.0006
91481169|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||<0.0001
91623466|NCT01170221|183139756|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.7|||||TWO_SIDED|95.0|-2.8|6.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||6.4|-2.8|
91713725|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.98|
91481170|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0028||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||0.0028
91623467|NCT02940626|183139801|OTHER|||||||0.547|||||||Wald Test on equality of proportions|||Subjects were analyzed for efficacy in the group to which they randomized. Sponsor defined outcomes were based on review of microbiology results from samples tested at the central lab. If sample was not sent to the central lab., determination was based on results from the local microbiology lab. In cases where both local \& central lab results were available, concordance was confirmed for S. aureus. Therefore, the analysis used local microbiology data in order to utilize a more complete dataset.||||.5470
91661416|NCT03285594|183217517|SUPERIORITY||Difference in LS Means|-21.832|STANDARD_ERROR_OF_MEAN|4.0514|<|0.0001|TWO_SIDED|95.0|-29.7725|-13.8911|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-13.8911|-29.7725|<0.0001
91661417|NCT03285594|183217518|SUPERIORITY||Difference in LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.716|-0.462|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-0.462|-1.716|0.0007
91661418|NCT03285594|183217518|SUPERIORITY||Difference in LS Means|-1.73|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-2.274|-1.183|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-1.183|-2.274|<0.0001
91661419|NCT03285594|183217519|SUPERIORITY||Difference in LS Means|-3.91|STANDARD_ERROR_OF_MEAN|1.904||0.04|TWO_SIDED|95.0|-7.642|-0.178|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.178|-7.642|0.04
91661420|NCT03285594|183217519|SUPERIORITY||Difference in LS Means|-3.83|STANDARD_ERROR_OF_MEAN|1.697||0.0239|TWO_SIDED|95.0|-7.161|-0.507|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.507|-7.161|0.0239
91661421|NCT03285594|183217520|SUPERIORITY||Difference in LS Means|-4.94|STANDARD_ERROR_OF_MEAN|1.425|||TWO_SIDED|95.0|-7.73|-2.142||||||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-2.142|-7.73|
91661422|NCT03285594|183217520|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|1.246||0.0018|TWO_SIDED|95.0|-6.333|-1.448|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-1.448|-6.333|0.0018
91661423|NCT03285594|183217521|SUPERIORITY||Difference in LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.34||0.1265|TWO_SIDED|95.0|-1.185|0.147|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.147|-1.185|0.1265
91661424|NCT03285594|183217521|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.32||0.074|TWO_SIDED|95.0|-1.199|0.055|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.055|-1.199|0.074
91661425|NCT03285594|183217522|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.868||0.2466|TWO_SIDED|95.0|-2.707|0.696|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.696|-2.707|0.2466
91661426|NCT03285594|183217522|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.672||0.332|TWO_SIDED|95.0|-1.969|0.665|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.665|-1.969|0.332
91661427|NCT00834431|183217525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.0||||||90.0|85.9|98.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.6|85.9|
91661428|NCT00834431|183217526|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.2|
91661429|NCT00834431|183217527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.7||||||90.0|96.3|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.3|
91661430|NCT00556322|183217540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7299|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7299
91661431|NCT00556322|183217543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6198|TWO_SIDED|95.0|0.72|1.21|||Log Rank|||Comparison of EGFR positive populations||1.21|0.72|0.6198
91661432|NCT00556322|183217543|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8398|TWO_SIDED|95.0|0.55|1.62|||Log Rank|||Comparison of EGFR negative populations||1.62|0.55|0.8398
91661433|NCT00556322|183217546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0885|TWO_SIDED|95.0|0.97|1.46|||Log Rank|||||1.46|0.97|0.0885
91661434|NCT00556322|183217549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.0662|TWO_SIDED|95.0|0.98|1.61|||Log Rank|||Comparison of EGFR positive populations||1.61|0.98|0.0662
91661435|NCT00556322|183217549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|95.0|0.61|1.69|||Log Rank|||Comparison of EGFR negative populations||1.69|0.61|0.9403
91661436|NCT00556322|183217551|SUPERIORITY_OR_OTHER||Difference in Response Rates|1.55||||0.5349|TWO_SIDED|95.0|-3.6|6.7||p-values are based on non-stratified analysis|Chi-squared||Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method|||6.7|-3.6|0.5349
91661437|NCT00556322|183217553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.1498|TWO_SIDED|95.0|0.93|1.59|||Log Rank|||||1.59|0.93|0.1498
91661438|NCT00556322|183217556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2202|TWO_SIDED|95.0|0.9|1.57|||Log Rank|||||1.57|0.90|0.2202
91661439|NCT00556322|183217559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.1063|TWO_SIDED|95.0|0.95|1.66|||Log Rank|||||1.66|0.95|0.1063
91661440|NCT03733444|183217561|SUPERIORITY||Least Squares (LS) Mean difference|2.8|STANDARD_ERROR_OF_MEAN|25.29||0.9123|TWO_SIDED|95.0|-46.9|52.4||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||52.4|-46.9|0.9123
91661441|NCT03733444|183217561|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|25.01||0.9456|TWO_SIDED|95.0|-47.4|50.8||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||50.8|-47.4|0.9456
91481171|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||<0.0001
91481172|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||1||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||1.0
91481173|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.643||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||0.6430
91481174|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1193||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||0.1193
91661442|NCT03733444|183217562|SUPERIORITY||Odds Ratio (OR)|1.15||||0.5162|TWO_SIDED|95.0|0.76|1.74|||Regression, Logistic|||||1.74|0.76|0.5162
91661443|NCT03733444|183217562|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7566|TWO_SIDED|95.0|0.71|1.62|||Regression, Logistic|||||1.62|0.71|0.7566
91661444|NCT03733444|183217563|SUPERIORITY||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|1.2|3.85|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.85|1.20|
91661445|NCT03733444|183217563|SUPERIORITY||Hazard Ratio (HR)|1.69|||||TWO_SIDED|95.0|0.93|3.1|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.10|0.93|
91661446|NCT03733444|183217564|SUPERIORITY||LS Mean difference|-0.1||||0.937|TWO_SIDED|95.0|-3.2|3.0||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||3.0|-3.2|0.9370
91661447|NCT03733444|183217564|SUPERIORITY||LS Mean difference|-0.4||||0.8064|TWO_SIDED|95.0|-3.4|2.7||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||2.7|-3.4|0.8064
91661448|NCT03733444|183217565|SUPERIORITY||LS Mean difference|2.9|STANDARD_ERROR_OF_MEAN|23.39|||TWO_SIDED|95.0|-41.1|46.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||46.8|-41.1|
91661449|NCT03733444|183217565|SUPERIORITY||LS Mean difference|8.0|STANDARD_ERROR_OF_MEAN|22.16|||TWO_SIDED|95.0|-35.5|51.5|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||51.5|-35.5|
91661450|NCT03733444|183217566|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.94|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.94|0.90|
91661451|NCT03733444|183217566|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.72|1.56|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.56|0.72|
91661452|NCT03733444|183217567|SUPERIORITY||LS Mean difference|0.9|||||TWO_SIDED|95.0|-12.4|14.1|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||14.1|-12.4|
91661453|NCT03733444|183217567|SUPERIORITY||LS Mean difference|3.6|||||TWO_SIDED|95.0|-10.4|17.6|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||17.6|-10.4|
91661454|NCT03733444|183217568|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.01|2.35|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||2.35|1.01|
91661455|NCT03733444|183217568|SUPERIORITY||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.91|2.16|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all cause hospitalization.|||2.16|0.91|
91661456|NCT03733444|183217571|SUPERIORITY||Hazard Ratio (HR)|2.92|||||TWO_SIDED|95.0|1.04|8.14|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||8.14|1.04|
91661457|NCT03733444|183217571|SUPERIORITY||Hazard Ratio (HR)|1.68|||||TWO_SIDED|95.0|0.55|5.13|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||5.13|0.55|
91661458|NCT03733444|183217572|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.82|1.06|
91623468|NCT00138424|183139845|SUPERIORITY_OR_OTHER||Spearman Correlation|0.24||||0.57|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.57
91623469|NCT00138424|183139845|SUPERIORITY_OR_OTHER||Spearman Correlation|0.26||||0.53|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.53
91623470|NCT00138424|183139845|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.3||||0.62|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.62
91623471|NCT00138424|183139845|SUPERIORITY_OR_OTHER||Spearman Correlation|0.8||||0.1|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.10
91623472|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.07||||0.87|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.87
91623473|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.31||||0.46|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.46
91623474|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.41||||0.49|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.49
91623475|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.87||||0.05|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.05
91623476|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.12||||0.78|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.78
91623477|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.52||||0.18|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.18
91623478|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.75
91623479|NCT00138424|183139846|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.75
91623480|NCT01802554|183139847|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||.039
91623481|NCT01802554|183139848|SUPERIORITY_OR_OTHER|||||||0.701|||||||Mixed Models Analysis|||||||.701
91623482|NCT01802554|183139849|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
91623483|NCT01802554|183139850|SUPERIORITY_OR_OTHER|||||||0.268|||||||Mixed Models Analysis|||||||.268
91661459|NCT03733444|183217572|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.06|0.86|
91623484|NCT01802554|183139851|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||||||.021
91623485|NCT02431468|183139890|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0||||LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.|t-test, 1 sided|||The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)||||<0.1
91623486|NCT02431468|183139890|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0|||||t-test, 1 sided|||Change from baseline in SIB in the Completer Analysis Set (CAS)||||<0.1
91623487|NCT01056341|183139896|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.~P-value linked to the 3 mg/kg/day 6 months selected arm ."|One-sided Z-tests|One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance||The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0||||< 0.0001
91661460|NCT03733444|183217573|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.82|1.06|
91661461|NCT03733444|183217573|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.06|0.86|
91661462|NCT03733444|183217574|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||3.31|1.20|
91661463|NCT03733444|183217574|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||2.54|0.88|
91623488|NCT01056341|183139897|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.|combination tests|Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes' adjustment.||"The objective is to test the superiority of the selected arm using the approach of Posch et al.~The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm."||||< 0.0001
91623489|NCT01167582|183139908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 1 Post Randomization||||<0.001
91623490|NCT01167582|183139908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 2 Post Randomization||||<0.001
91623491|NCT01167582|183139908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 3 Post Randomization||||<0.001
91623492|NCT01167582|183139909|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91623493|NCT01167582|183139910|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||||TWO_SIDED|95.0|0.99|5.73|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||5.73|0.99|
91623494|NCT01167582|183139911|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.7||||||95.0|-5.3|24.7|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||24.7|-5.3|
91623495|NCT01167582|183139912|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.13|||||TWO_SIDED|95.0|0.91|56.02|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Mortality||56.02|0.91|
91623496|NCT01167582|183139912|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.48|4.22|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Myocardial Infarction||4.22|0.48|
91623497|NCT03956225|183139921|NON_INFERIORITY|Noninferiority in change from baseline in MGS was declared if the lower confidence limit (LCL) was greater than -5.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||ONE_SIDED|95.0|-2.2||||Mixed effects repeated measures||Standard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.||||-2.2|
91623498|NCT01583452|183139923|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||Kaplan-Meier survival analysis|||With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.||||0.665
91623499|NCT01583452|183139924|SUPERIORITY_OR_OTHER|||||||0.094|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.094
91623500|NCT01583452|183139925|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.059
91623501|NCT01583452|183139926|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.830
91623502|NCT02157506|183139935|SUPERIORITY||||||=|0.0059|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||=0.0059
91623503|NCT02157506|183139935|SUPERIORITY||||||=|0.0001|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0001
91623504|NCT02157506|183139935|SUPERIORITY||||||=|0.0062|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0062
91623505|NCT02157506|183139935|SUPERIORITY||||||=|0.0086|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0086
91623506|NCT02157506|183139936|SUPERIORITY||||||=|0.0076|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0076
91623507|NCT02157506|183139936|SUPERIORITY||||||=|0.0052|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0052
91623508|NCT02157506|183139936|SUPERIORITY||||||=|0.1064|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1064
91713726|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.97|
91623509|NCT02157506|183139936|SUPERIORITY||||||=|0.1151|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1151
91623510|NCT02157506|183139937|SUPERIORITY||||||=|0.4241|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4241
91623511|NCT02157506|183139937|SUPERIORITY||||||=|0.4035|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4035
91623512|NCT02157506|183139937|SUPERIORITY||||||=|0.8308|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8308
91623513|NCT02157506|183139937|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1180
91623514|NCT02157506|183139938|SUPERIORITY||||||=|0.0048|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0048
91623515|NCT02157506|183139938|SUPERIORITY||||||=|0.0022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0022
91623516|NCT02157506|183139938|SUPERIORITY||||||=|0.0045|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0045
91623517|NCT02157506|183139938|SUPERIORITY||||||=|0.0294|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0294
91623518|NCT02157506|183139939|SUPERIORITY||||||=|0.2022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2022
91623519|NCT02157506|183139939|SUPERIORITY||||||=|0.0658|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0658
91713727|NCT04110314|183318948|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.04|1.00|
91481175|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||<0.0001
91481176|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4861||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.4861
91481177|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0002||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.0002
91481178|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3247||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.3247
91623520|NCT02157506|183139939|SUPERIORITY||||||=|0.0741|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0741
91623521|NCT02157506|183139939|SUPERIORITY||||||=|0.0497|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0497
91623522|NCT02157506|183139940|SUPERIORITY||||||=|0.1842|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1842
91623523|NCT02157506|183139940|SUPERIORITY||||||=|0.3328|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.3328
91623524|NCT02157506|183139940|SUPERIORITY||||||=|0.1465|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1465
91623525|NCT02157506|183139940|SUPERIORITY||||||=|0.2799|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2799
91623526|NCT02157506|183139941|SUPERIORITY||||||=|0.2499|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2499
91623527|NCT02157506|183139941|SUPERIORITY||||||=|0.8281|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8281
91623528|NCT02157506|183139941|SUPERIORITY||||||=|0.4121|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4121
91623529|NCT02157506|183139941|SUPERIORITY||||||=|0.8592|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8592
91623530|NCT02157506|183139942|SUPERIORITY||||||=|0.1391|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1391
91623531|NCT02157506|183139942|SUPERIORITY||||||=|0.1724|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1724
91623532|NCT02157506|183139942|SUPERIORITY||||||=|0.1245|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1245
91623533|NCT02157506|183139942|SUPERIORITY||||||=|0.169|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1690
91623534|NCT02157506|183139943|SUPERIORITY||||||=|0.4936|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4936
91623535|NCT02157506|183139943|SUPERIORITY||||||=|0.992|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9920
91623536|NCT02157506|183139943|SUPERIORITY||||||=|0.2789|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2789
91623537|NCT02157506|183139943|SUPERIORITY||||||=|0.91|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9100
91623538|NCT00868452|183139944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.25||0.005|||||||Mixed Models Analysis|||||||0.005
91623539|NCT00868452|183139945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.003|||||||Mixed Models Analysis|||||||0.003
91623540|NCT00868452|183139946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.01||0.012|||||||ANCOVA|||||||0.012
91623541|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.42|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-77.55|-65.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.29|-77.55|<0.001
91623542|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.16|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-65.94|-52.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.38|-65.94|<0.001
91661464|NCT03733444|183217575|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||3.31|1.20|
91623543|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.6|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-45.81|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.40|-45.81|<0.001
91623544|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.1|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-47.83|-34.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-34.37|-47.83|<0.001
91623545|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.29|STANDARD_ERROR_OF_MEAN|5.36|<|0.001|TWO_SIDED|95.0|-86.87|-65.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.72|-86.87|<0.001
91623546|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.51|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-79.81|-61.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.20|-79.81|<0.001
91623547|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.2|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-57.54|-36.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.86|-57.54|<0.001
91623548|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.88|STANDARD_ERROR_OF_MEAN|4.73|<|0.001|TWO_SIDED|95.0|-48.21|-29.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-29.56|-48.21|<0.001
91623549|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.21|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-74.72|-61.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.70|-74.72|<0.001
91623550|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.49|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-70.84|-58.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.14|-70.84|<0.001
91623551|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.31|STANDARD_ERROR_OF_MEAN|4.42|<|0.001|TWO_SIDED|95.0|-77.04|-59.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.57|-77.04|<0.001
91623552|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-65.31|-44.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.65|-65.31|<0.001
91661465|NCT03733444|183217575|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||2.54|0.88|
91661466|NCT05446870|183217639|OTHER||Posterior probability (%)|100.0|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of pCR, adjusted for baseline ctDNA and treatment assignment.|||
91661467|NCT05446870|183217641|OTHER||Posterior probability (%)|90.99|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of CRS (CRS3 coded as 1 and CRS1 or 2 coded as 0), adjusted for baseline ctDNA and treatment assignment.|||
91481179|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4627||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.4627
91623553|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.56|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-76.72|-64.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.41|-76.72|<0.001
91623554|NCT01763866|183139957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.41|STANDARD_ERROR_OF_MEAN|4.41|<|0.001|TWO_SIDED|95.0|-69.11|-51.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.72|-69.11|<0.001
91623555|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.95|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-75.38|-64.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.51|-75.38|<0.001
91623556|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-69.06|-56.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-56.57|-69.06|<0.001
91623557|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.03|-32.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-32.03|-43.03|<0.001
91623558|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.49|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-49.7|-37.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-37.28|-49.70|<0.001
91623559|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.92|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-84.49|-65.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.35|-84.49|<0.001
91661468|NCT05446870|183217642|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% confidence interval (CI) were based on Miettinen \& Nurminen method.|Difference in Percentage|1.1|||||TWO_SIDED|95.0|-10.0|12.9||||||||12.9|-10.0|
91661469|NCT05446870|183217643|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% CI were based on Miettinen \& Nurminen method.|Difference in Percentage|20.7|||||TWO_SIDED|95.0|3.5|37.0||||||||37.0|3.5|
91722478|NCT06525727|183337723|OTHER||Sensitivity|97.96|||||TWO_SIDED|95.0|89.15|99.95|||Diagnostic accuracy|Diagnostic performance was analyzed in terms of sensitivity, specificity, NPV, PPV and likelihood ratios, all reported with 95% confidence interval||The primary objective of the study was to assess the external validation of the Falls Decision Rule. In this evaluation, patients were categorized into two groups based on the rule: those for whom a CT scan was recommended and those for whom it was not.||99.95|89.15|
91722479|NCT06525727|183337723|OTHER||Specificity|31.96|||||TWO_SIDED|95.0|28.63|35.42|||Diagnostic accuracy|||||35.42|28.63|
91722480|NCT06525727|183337723|OTHER||Negative predictive value|99.59|||||TWO_SIDED|95.0|97.17|99.94|||Diagnostic accuracy|||||99.94|97.17|
91481180|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1244||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.1244
91481181|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0575||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0575
91623560|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.81|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-83.0|-66.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-66.62|-83.00|<0.001
91623561|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.95|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED|95.0|-54.32|-35.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.57|-54.32|<0.001
91623562|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.81|STANDARD_ERROR_OF_MEAN|4.19|<|0.001|TWO_SIDED|95.0|-52.06|-35.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.55|-52.06|<0.001
91623563|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.88|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-72.67|-61.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.08|-72.67|<0.001
91623564|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.58|STANDARD_ERROR_OF_MEAN|3.05|<|0.001|TWO_SIDED|95.0|-72.6|-60.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.56|-72.60|<0.001
91623565|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.66|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-73.19|-58.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.12|-73.19|<0.001
91623566|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.91|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-71.37|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-71.37|<0.001
91623567|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.43|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-74.86|-64.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.01|-74.86|<0.001
91623568|NCT01763866|183139958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.45|STANDARD_ERROR_OF_MEAN|4.17|<|0.001|TWO_SIDED|95.0|-76.68|-60.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.22|-76.68|<0.001
91623569|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.6|-74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-74.6|-92.6|<0.001
91623570|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-90.2|-69.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-69.2|-90.2|<0.001
91623571|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-53.4|-35.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.3|-53.4|<0.001
91481182|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7489||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.7489
91661470|NCT05446870|183217646|OTHER||Posterior probability (%)|38.75|||||||||||||||Posterior probability (based on 20000 sets of model parameters) coefficient for treatment assignment (MK-4830 containing vs. not) less than zero in Bayesian parametrization of the constrained longitudinal data analysis (cLDA) model, modeling ctDNA value at Cycle 3 and ctDNA value at baseline as bivariate normal.|||
91661471|NCT01686438|183217661|NON_INFERIORITY|The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.|Mean Difference (Net)|-2.03|STANDARD_DEVIATION|1.33||0.138|TWO_SIDED|95.0|-4.63|1.57|||t-test, 1 sided|||||1.57|-4.63|0.138
91661472|NCT00984126|183217675|SUPERIORITY_OR_OTHER||Incidence rate|0.0|||||ONE_SIDED|95.0||1.4||||||A one-sided 95% upper confidence limit was based on an exact calculation for a binomial distribution.||1.4||
91661473|NCT02009163|183217712|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value based on a log-rank test, stratified by 4-week cessation status (Yes, No). 4-week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization.|Log Rank|||||||<0.001
91481183|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0098||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0098
91481184|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1797||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1797
91481185|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3613||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.3613
91481186|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.5972||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.5972
91481187|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.024||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0240
91481188|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2437||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.2437
91661474|NCT02009163|183217713|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.42||Nominal P-value not adjusted for multiplicity.|mixed- effects model for repeated measur|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-0.42|-0.81|<0.001
91661475|NCT02009163|183217714|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Unadjusted P-value for the difference in distribution between treatment groups in CGI-S.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGI-S as the covariate.||||||<0.001
91661476|NCT02009163|183217715|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-5.6|||<|0.001|TWO_SIDED|95.0|-7.2|-3.9||Nominal P-value not adjusted for multiplicity.|mixed-effects model for repeated measure|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-3.9|-7.2|<0.001
91661477|NCT00833586|183217746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|95.1||||||90.0|85.8|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.4|85.8|
91661478|NCT00833586|183217747|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.9||||||90.0|82.7|118.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||118.4|82.7|
91661479|NCT00833586|183217748|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|102.4||||||90.0|95.0|110.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.5|95.0|
91661480|NCT00304187|183217751|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91661481|NCT01141374|183217763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0667|STANDARD_DEVIATION|17.28||0.352|TWO_SIDED|95.0|-76.0|23.0||The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p\<0.05.|ANOVA|||Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.||23.00|-76.00|0.352
91722481|NCT06525727|183337723|OTHER||Positive predictive value|8.59|||||TWO_SIDED|95.0|8.1|9.1|||Diagnostic accuracy|||||9.1|8.1|
91722482|NCT06525727|183337723|OTHER||Negative likelihood ratio|0.06|||||TWO_SIDED|95.0|0.01|0.42|||Diagnostic accuracy|||||0.42|0.01|
91481189|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0631||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0631
91481190|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.054||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.0540
91481191|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7298||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7298
91481192|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4218||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.4218
91481193|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2282||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.2282
91481194|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8711||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.8711
91481195|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0027||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0027
91623572|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-65.4|-44.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.6|-65.4|<0.001
91623573|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.9|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-81.9|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.8|-81.9|<0.001
91623574|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-74.5|-56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.7|-74.5|<0.001
91623575|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-57.7|-33.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.9|-57.7|<0.001
91623576|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-47.8|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.9|-47.8|<0.001
91623577|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.4|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-83.9|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.0|-83.9|<0.001
91623578|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-88.0|-67.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.8|-88.0|<0.001
91623579|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-63.1|-48.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.4|-63.1|<0.001
91623580|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-60.6|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.6|-60.6|<0.001
91722483|NCT06525727|183337723|OTHER||Positive likelihood ratio|1.44|||||TWO_SIDED|95.0|1.35|1.53|||Diagnostic accuracy|||||1.53|1.35|
91623581|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-78.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-86.2|-70.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.0|-86.2|<0.001
91661482|NCT01141374|183217764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9067|STANDARD_DEVIATION|19.21||0.023|TWO_SIDED|95.0|-67.0|37.0||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||37.00|-67.00|0.023
91661483|NCT03769025|183217765|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||.1
91661484|NCT03769025|183217766|SUPERIORITY|||||||0.959|||||||t-test, 2 sided|||||||.959
91661485|NCT03374176|183217767|EQUIVALENCE||Mean Difference (Net)|0.05|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||chi-square|||<0.05
91661486|NCT02911701|183217771|SUPERIORITY|||||||0.3|||||||maxim|||||||0.3
91661487|NCT01110005|183217803|SUPERIORITY||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.7|2.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||2.3|0.7|0.34
91661488|NCT01110005|183217804|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4|TWO_SIDED|95.0|0.9|1.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||1.3|0.9|0.40
91481196|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7579||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7579
91661489|NCT01110005|183217805|SUPERIORITY|||||||0.69|||||||Cochran-Mantel-Haenszel|This method was used to control for site of recruitment||||||0.69
91661490|NCT03290781|183217830|SUPERIORITY||Difference in Proportion|0.451|||<|0.001|TWO_SIDED|95.0|0.296|0.572||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.572|0.296|<0.001
91661491|NCT03290781|183217830|SUPERIORITY||Difference in Proportion|0.278|||<|0.001|TWO_SIDED|95.0|0.142|0.401||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.401|0.142|<0.001
91481197|NCT03239665|182835477|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1299||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1299
91661492|NCT03290781|183217831|SUPERIORITY||Difference in Proportion|0.463|||<|0.001|TWO_SIDED|95.0|0.31|0.585||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.585|0.310|<0.001
91661493|NCT03290781|183217831|SUPERIORITY||Difference in Proportion|0.339|||<|0.001|TWO_SIDED|95.0|0.197|0.463||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.463|0.197|<0.001
91661494|NCT03290781|183217832|SUPERIORITY||Difference in Proportion|0.497|||<|0.001|TWO_SIDED|95.0|0.337|0.62||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.620|0.337|<0.001
91661495|NCT03290781|183217832|SUPERIORITY||Difference in Proportion|0.294|||<|0.001|TWO_SIDED|95.0|0.148|0.425||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.425|0.148|<0.001
91661496|NCT03290781|183217833|SUPERIORITY||Difference in Proportion|0.277|||<|0.001|TWO_SIDED|95.0|0.129|0.398||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.398|0.129|<0.001
91661497|NCT03290781|183217833|SUPERIORITY||Difference in Proportion|0.191|||<|0.001|TWO_SIDED|95.0|0.067|0.305||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.305|0.067|<0.001
91661498|NCT03290781|183217834|SUPERIORITY||Difference in Proportion|0.488|||<|0.001|TWO_SIDED|95.0|0.329|0.613||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.613|0.329|<0.001
91661499|NCT03290781|183217834|SUPERIORITY||Difference in Proportion|0.343|||<|0.001|TWO_SIDED|95.0|0.194|0.471||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.471|0.194|<0.001
91661500|NCT03290781|183217835|SUPERIORITY||Difference in Proportion|0.431|||<|0.001|TWO_SIDED|95.0|0.28|0.554||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.554|0.280|<0.001
91713728|NCT01711983|183318990|NON_INFERIORITY|Non-inferiority margin based on 1) the lower 95% confidence bound (= 0.82) for estimated 6-month composite Clinical Success for the historical device (219/253=0.866), and 2) a worst-case analysis of 6-month composite Clinical Success for the historical device (0.81, assuming the 18 subjects with missing echo evaluations were failures).|Risk Difference (RD)|-0.0366|||<|0.0001|ONE_SIDED|95.0||0.007||A priori 1-sided alpha = 0.05.|2-sample binomial proportions test||Difference is control - test. Confidence interval is the upper one-sided 95% Wald confidence interval.|"Test null hypothesis of inferiority of test device (test) compared to historical device (control).~H0: Pc - Pt ≥ Δ vs H1: Pc - Pt \< Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.~Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0."||0.007||<0.0001
91481198|NCT03239665|182835479|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program immediately post-intervention via Fisher's Exact test||||1.0
91481199|NCT03239665|182835479|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.6806||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program at the one-month follow-up via Fisher's Exact test||||0.6806
91481200|NCT03239665|182835479|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content immediately post-intervention via Fisher's Exact test||||1.0
91623582|NCT01763866|183139959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.1|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-91.7|-68.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-68.6|-91.7|<0.001
91623583|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-85.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-95.2|-75.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-75.9|-95.2|<0.001
91623584|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-86.8|-64.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-64.9|-86.8|<0.001
91623585|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-56.6|-37.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.1|-56.6|<0.001
91623586|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-62.6|-40.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.9|-62.6|<0.001
91623587|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|6.4|<|0.001|TWO_SIDED|95.0|-84.4|-59.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-59.0|-84.4|<0.001
91623588|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-71.6|-52.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.0|-71.6|<0.001
91623589|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.0|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-61.5|-36.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.6|-61.5|<0.001
91623590|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-45.2|-25.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.5|-45.2|<0.001
91623591|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.1|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-86.2|-67.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.9|-86.2|<0.001
91623592|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-86.3|-65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-65.3|-86.3|<0.001
91623593|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-65.1|-49.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.4|-65.1|<0.001
91481201|NCT03239665|182835479|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.4908||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content at the one-month follow-up via Fisher's Exact test||||0.4908
91623594|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-55.9|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.4|-55.9|<0.001
91661501|NCT03290781|183217835|SUPERIORITY||Difference in Proportion|0.227|||<|0.001|TWO_SIDED|95.0|0.094|0.349||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.349|0.094|<0.001
91623595|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.0|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-87.5|-70.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.4|-87.5|<0.001
91623596|NCT01763866|183139960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-83.8|-60.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-60.0|-83.8|<0.001
91623597|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.28|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-65.29|-55.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.27|-65.29|<0.001
91623598|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.37|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-63.23|-51.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.51|-63.23|<0.001
91623599|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.77|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-37.84|-27.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.70|-37.84|<0.001
91623600|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-45.34|-33.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.71|-45.34|<0.001
91623601|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.17|STANDARD_ERROR_OF_MEAN|4.37|<|0.001|TWO_SIDED|95.0|-73.78|-56.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.56|-73.78|<0.001
91481202|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7728|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at baseline via Chi-squared test||||0.7728
91481203|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6871|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6871
91623602|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.76|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-72.32|-57.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.19|-72.32|<0.001
91623603|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.25|STANDARD_ERROR_OF_MEAN|4.28|<|0.001|TWO_SIDED|95.0|-46.68|-29.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.81|-46.68|<0.001
91623604|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.52|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-45.15|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.90|-45.15|<0.001
91481204|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8259|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.8259
91623605|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.61|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-64.73|-54.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.48|-64.73|<0.001
91661502|NCT03290781|183217836|SUPERIORITY||Difference in Proportion|0.176|||<|0.001|TWO_SIDED|95.0|0.049|0.287||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.287|0.049|<0.001
91661503|NCT03290781|183217836|SUPERIORITY||Difference in Proportion|0.111|||<|0.005|TWO_SIDED|95.0|0.006|0.208||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.208|0.006|<0.005
91623606|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.2|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-64.8|-53.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.60|-64.80|<0.001
91623607|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.27|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|95.0|-64.6|-51.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.94|-64.60|<0.001
91623608|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.31|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-64.29|-50.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.32|-64.29|<0.001
91623609|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-65.18|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.18|<0.001
91623610|NCT01763866|183139961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-70.22|-55.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-55.42|-70.22|<0.001
91623611|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.84|<|0.001|TWO_SIDED|95.0|-67.25|-56.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.03|-67.25|<0.001
91623612|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.93|STANDARD_ERROR_OF_MEAN|3.28|<|0.001|TWO_SIDED|95.0|-61.4|-48.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.46|-61.40|<0.001
91623613|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.11|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-40.79|-29.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.44|-40.79|<0.001
91623614|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.72|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-44.15|-31.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.30|-44.15|<0.001
91623615|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.64|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-75.88|-57.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.39|-75.88|<0.001
91623616|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-68.49|-51.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.52|-68.49|<0.001
91623617|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.51|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|-49.55|-31.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.47|-49.55|<0.001
91661504|NCT03290781|183217837|SUPERIORITY||||||<|0.001||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||<0.001
91661505|NCT03290781|183217837|SUPERIORITY||||||=|0.005||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||=0.005
91661506|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
91481205|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8868|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at baseline via Chi-squared test||||0.8868
91481206|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8069|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.8069
91481207|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8489|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8489
91623618|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.79|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-41.3|-24.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.28|-41.30|<0.001
91623619|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.96|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-65.78|-54.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.13|-65.78|<0.001
91623620|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.42|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.27|-51.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.57|-63.27|<0.001
91623621|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.58|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-66.95|-52.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.21|-66.95|<0.001
91623622|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.76|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-58.26|-41.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.27|-58.26|<0.001
91623623|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.91|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-66.57|-55.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.24|-66.57|<0.001
91623624|NCT01763866|183139962|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.63|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-64.63|-48.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-48.62|-64.63|<0.001
91623625|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.49|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-63.1|-53.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.89|-63.10|<0.001
91623626|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.25|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-57.49|-47.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-47.01|-57.49|<0.001
91623627|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.66|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-38.33|-28.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.98|-38.33|<0.001
91661507|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
91623628|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.67|<|0.001|TWO_SIDED|95.0|-45.27|-34.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.74|-45.27|<0.001
91623629|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.34|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-66.61|-52.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.07|-66.61|<0.001
91623630|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.74|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-65.56|-51.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.93|-65.56|<0.001
91661508|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
91661509|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
91661510|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.3||||||||1.3|1.0|
91661511|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
91661512|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.4||||||||1.4|1.1|
91713729|NCT00737100|183318997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.001||95.0|1.19|4.7||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.70|1.19|0.001
91661513|NCT01077596|183217847|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
91661514|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.4||||||95.0|0.9|2.2||||||||2.2|0.9|
91661515|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|0.8|2.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||2.0|0.8|
91661516|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|0.8|2.0||||||||2.0|0.8|
91661517|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
91713730|NCT00737100|183318997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39||||0.0001||95.0|1.67|5.12||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.67|0.0001
91713731|NCT00737100|183318998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.0184||95.0|0.38|4.11||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.11|0.38|0.0184
91481208|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3985|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at baseline via Chi-squared test||||0.3985
91481209|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1722|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.1722
91481210|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7318|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7318
91481211|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6309|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6309
91481212|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7881|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.7881
91661518|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.3||||||95.0|0.8|2.1||||||||2.1|0.8|
91661519|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
91661520|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.2||||||95.0|1.2|3.9||||||||3.9|1.2|
91661521|NCT01077596|183217848|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.0||||||95.0|1.1|3.6|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.6|1.1|
91661522|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|3.2|6.3||||||||6.3|3.2|
91661523|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|2.0|4.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.4|2.0|
91661524|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.0||||||95.0|2.8|5.8||||||||5.8|2.8|
91661525|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
91661526|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.4||||||95.0|3.1|6.3||||||||6.3|3.1|
91661527|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
91661528|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|2.8|7.2||||||||7.2|2.8|
91661529|NCT01077596|183217849|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.5||||||95.0|2.1|5.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||5.9|2.1|
91661530|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.7|4.1||||||||4.1|1.7|
91661531|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.1||||||95.0|1.3|3.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.4|1.3|
91661532|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.4|3.6||||||||3.6|1.4|
91481213|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6798|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.6798
91713732|NCT00737100|183318998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.0179||95.0|0.38|4.06||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||4.06|0.38|0.0179
91713733|NCT00737100|183318999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83||||0.0756||95.0|-0.19|3.86|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||3.86|-0.19|0.0756
91713734|NCT00737100|183318999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.12||||0.0023||95.0|1.12|5.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.12|0.0023
91713735|NCT00737100|183319000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.3857||95.0|-1.08|2.79|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||2.79|-1.08|0.3857
91481214|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8548|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8548
91481215|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3182|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.3182
91481216|NCT03239665|182835480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7986|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7986
91623631|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-42.09|-27.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.75|-42.09|<0.001
91623632|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.64|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-46.57|-32.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.71|-46.57|<0.001
91623633|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.86|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-59.66|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.05|-59.66|<0.001
91623634|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.14|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-60.66|-51.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.61|-60.66|<0.001
91623635|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.78|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-56.72|-44.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.83|-56.72|<0.001
91623636|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.94|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-61.11|-48.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.76|-61.11|<0.001
91623637|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.34|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.94|-50.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.74|-59.94|<0.001
91623638|NCT01763866|183139963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.87|STANDARD_ERROR_OF_MEAN|3.24|<|0.001|TWO_SIDED|95.0|-63.27|-50.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.46|-63.27|<0.001
91623639|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.79|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-64.03|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.55|-64.03|<0.001
91623640|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.36|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-53.2|-41.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.52|-53.20|<0.001
91713736|NCT00737100|183319000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.2199||95.0|-0.72|3.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||3.11|-0.72|0.2199
91713737|NCT00737100|183319001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0363||95.0|0.27|8.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||8.11|0.27|0.0363
91713738|NCT00737100|183319001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34||||0.0073||95.0|1.45|9.23|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||9.23|1.45|0.0073
91481217|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0163|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at baseline via Chi-squared test||||0.0163
91481218|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0028|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine post-intervention via Chi-squared test||||0.0028
91481219|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0433|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.0433
91481220|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0592|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at baseline via Chi-squared test||||0.0592
91481221|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1843|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine post-intervention via Chi-squared test||||0.1843
91481222|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.5933|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.5933
91481223|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3942|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at baseline via Chi-squared test||||0.3942
91481224|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9062|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine post-intervention via Chi-squared test||||0.9062
91623641|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-40.23|-29.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.60|-40.23|<0.001
91623642|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.21|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-42.06|-30.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.35|-42.06|<0.001
91623643|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-69.27|-53.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.54|-69.27|<0.001
91623644|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-60.77|-45.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-45.25|-60.77|<0.001
91623645|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.45|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-45.17|-29.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.74|-45.17|<0.001
91623646|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.31|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-42.15|-26.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.47|-42.15|<0.001
91623647|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|-61.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.40|-61.60|<0.001
91623648|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.21|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-58.29|-48.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.13|-58.29|<0.001
91623649|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.52|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-57.06|-43.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-43.99|-57.06|<0.001
91623650|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.95|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-54.43|-39.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.47|-54.43|<0.001
91481225|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9618|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.9618
91481226|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.114|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.1140
91525085|NCT03324880|182925470|SUPERIORITY||Difference in LS Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.112|=|0.002|TWO_SIDED|95.0|-0.55|-0.1||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact subscale score.|-0.10|-0.55|=0.002
91661533|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
91661534|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.5|3.7||||||||3.7|1.5|
91661535|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
91661536|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.5|4.5||||||||4.5|1.5|
91661537|NCT01077596|183217850|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.2||||||95.0|1.3|3.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.9|1.3|
91481227|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0141|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.0141
91661538|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.3||||||||1.3|0.5|
91661539|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.7||||||95.0|0.4|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.4|
91661540|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.6||||||95.0|0.4|1.1||||||||1.1|0.4|
91661541|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||||95.0|0.3|1.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.0|0.3|
91481228|NCT03239665|182835481|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0457|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.0457
91481229|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6153|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at baseline via Chi-squared test||||0.6153
91527724|NCT01976364|182930501|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
91661542|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.4||||||||1.4|0.5|
91661543|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.8||||||95.0|0.4|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|0.4|
91661544|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.6|2.0||||||||2.0|0.6|
91661545|NCT01077596|183217851|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.6|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status†, previous depression dx, previous IBD‡ diagnosis, OC§ use, HRT/ERT use, and NSAID use.|||1.9|0.6|
91661546|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.9||||||95.0|0.8|1.1||||||||1.1|0.8|
91661547|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
91661548|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
91661549|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
91661550|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.8|1.1||||||||1.1|0.8|
91661551|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
91661552|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.3||||||||1.3|0.9|
91661553|NCT01077596|183217852|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.9|
91661554|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|1.0|1.3||||||||1.3|1.0|
91481230|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8299|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor post-intervention via Chi-squared test||||0.8299
91623651|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.3|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-61.47|-51.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.14|-61.47|<0.001
91623652|NCT01763866|183139964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.73|STANDARD_ERROR_OF_MEAN|3.38|<|0.001|TWO_SIDED|95.0|-59.4|-46.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-46.06|-59.40|<0.001
91623653|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.41|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-50.66|-42.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.15|-50.66|<0.001
91623654|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.69|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-49.75|-39.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.63|-49.75|<0.001
91623655|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.06|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-30.36|-21.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.75|-30.36|<0.001
91623656|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.59|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-36.61|-26.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.57|-36.61|<0.001
91623657|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.48|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-50.69|-38.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.27|-50.69|<0.001
91623658|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.85|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.48|-41.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.21|-52.48|<0.001
91623659|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.001|TWO_SIDED|95.0|-34.39|-22.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.21|-34.39|<0.001
91623660|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.18|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-33.86|-22.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.50|-33.86|<0.001
91623661|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-49.5|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.97|-49.50|<0.001
91623662|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.01|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-52.46|-41.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.57|-52.46|<0.001
91661555|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
91661556|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.4||||||||1.4|1.0|
91661557|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|1.0|
91661558|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.2||||||||1.2|0.9|
91661559|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|0.9|
91661560|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
91713739|NCT00737100|183319002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7414||95.0|-0.06|0.08|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||0.08|-0.06|0.7414
91661561|NCT01077596|183217853|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.8|
91661562|NCT02538523|183217854|SUPERIORITY||||||<|0.005|||||||Fisher Exact|||A Fischer's Exact Test for two independent proportions was conducted to compare the statistical significance of the 44.8% difference in proportion of successes between procedure groups at two-months post-procedure (study endpoint) relative to baseline evaluation.||||<0.005
91661563|NCT02538523|183217855|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Differences is the statistical significance of change scores in ODI total score from study baseline to endpoint (two-months post-procedure) were evaluated by Analysis of Covariance (ANCOVA), with change from baseline to endpoint in ODI total score as the dependent variable, baseline ODI total score as the covariate and procedure group (Erchonia FX-635 or placebo laser) as a main effect.||||<0.05
91661564|NCT03697109|183217874|EQUIVALENCE|Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).|Odds Ratio (OR)|0.17||||0.0215|TWO_SIDED|95.0|0.04|0.77|||Chi-squared||An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.|A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.||0.77|0.04|0.0215
91661565|NCT02301975|183217900|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit PM FEV1 for FF/VI and FP/S was more than -100 milliliter (mL)|Least square mean change difference|0.019|||||TWO_SIDED|95.0|-0.011|0.049||||||||0.049|-0.011|
91661566|NCT02301975|183217900|OTHER||Least square mean change difference|0.123|||<|0.001|TWO_SIDED|95.0|0.093|0.153|||Mixed Models Analysis|||||0.153|0.093|<0.001
91661567|NCT02301975|183217900|OTHER||Least square mean change difference|0.104|||<|0.001|TWO_SIDED|95.0|0.074|0.134|||Mixed Models Analysis|||||0.134|0.074|<0.001
91661568|NCT02301975|183217901|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit for FF/VI and FP/S was more than -100 mL|Least square mean change difference|0.006|||||TWO_SIDED|95.0|-0.027|0.04||||||||0.040|-0.027|
91661569|NCT02301975|183217901|OTHER||Least square mean change difference|0.12|||<|0.001|TWO_SIDED|95.0|0.086|0.153|||Mixed Models Analysis|||||0.153|0.086|<0.001
91661570|NCT02301975|183217901|OTHER||Least square mean change difference|0.113|||<|0.001|TWO_SIDED|95.0|0.08|0.147|||Mixed Models Analysis|||||0.147|0.080|<0.001
91661571|NCT02301975|183217902|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.5|3.0||||||||3.0|-0.5|
91661572|NCT02301975|183217902|OTHER||Least square mean change difference|2.7||||0.002|TWO_SIDED|95.0|0.9|4.4|||ANCOVA|||||4.4|0.9|0.002
91661573|NCT02301975|183217902|OTHER||Least square mean change difference|1.4||||0.106|TWO_SIDED|95.0|-0.3|3.2|||ANCOVA|||||3.2|-0.3|0.106
91481231|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0405|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at one-month follow-up via Chi-squared test||||0.0405
91661574|NCT02301975|183217903|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.7|3.1||||||||3.1|-0.7|
91661575|NCT02301975|183217903|OTHER||Least square mean change difference|2.7||||0.004|TWO_SIDED|95.0|0.8|4.5|||ANCOVA|||||4.5|0.8|0.004
91661576|NCT02301975|183217903|OTHER||Least square mean change difference|1.5||||0.115|TWO_SIDED|95.0|-0.4|3.3|||ANCOVA|||||3.3|-0.4|0.115
91661577|NCT02301975|183217904|OTHER||Least square mean change difference|5.2|||||TWO_SIDED|95.0|1.1|9.4||||||||9.4|1.1|
91661578|NCT02301975|183217904|OTHER||Least square mean change difference|21.5|||<|0.001|TWO_SIDED|95.0|17.4|25.6|||ANCOVA|||||25.6|17.4|<0.001
91661579|NCT02301975|183217904|OTHER||Least square mean change difference|16.3|||<|0.001|TWO_SIDED|95.0|12.2|20.4|||ANCOVA|||||20.4|12.2|<0.001
91661580|NCT02301975|183217905|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.53|1.54||||||||1.54|0.53|
91661581|NCT02301975|183217905|OTHER||Odds Ratio (OR)|1.15||||0.595|TWO_SIDED|95.0|0.69|1.9|||Regression, Logistic|||||1.90|0.69|0.595
91661582|NCT02301975|183217905|OTHER||Odds Ratio (OR)|1.27||||0.372|TWO_SIDED|95.0|0.75|2.12|||Regression, Logistic|||||2.12|0.75|0.372
91661583|NCT02301975|183217906|OTHER||Least square mean change difference|5.0|||||TWO_SIDED|95.0|0.7|9.3||||||||9.3|0.7|
91661584|NCT02301975|183217906|OTHER||Least square mean change difference|19.2|||<|0.001|TWO_SIDED|95.0|14.9|23.5|||ANCOVA|||||23.5|14.9|<0.001
91661585|NCT02301975|183217906|OTHER||Least square mean change difference|14.2|||<|0.001|TWO_SIDED|95.0|9.9|18.5|||ANCOVA|||||18.5|9.9|<0.001
91661586|NCT00835991|183217907|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|114.05||||||90.0|107.26|121.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.27|107.26|
91661587|NCT00835991|183217908|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.63||||||90.0|97.59|103.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.76|97.59|
91661588|NCT00835991|183217909|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.36||||||90.0|98.32|104.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.48|98.32|
91661589|NCT00835991|183217910|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.05||||||90.0|94.31|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|94.31|
91661590|NCT00835991|183217911|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05|Test/Ref Ratio of LS Means x 100|96.55||||||90.0|93.85|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.32|93.85|
91661591|NCT00835991|183217912|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.44||||||90.0|93.71|99.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.25|93.71|
91661592|NCT02149420|183217913|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_DEVIATION|2.058||0.678|TWO_SIDED|95.0|-5.007|3.18|||repeated measures Bayesian analysis|with baseline as a covariate||Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.||3.180|-5.007|0.678
91661593|NCT04278560|183217927|SUPERIORITY||Mean Difference (Net)|385.3||||0.009|TWO_SIDED|||||Repeated Measures Two-Way ANOVA: Group, Time, Group x Time, and controlled by Baseline Step Counts|ANOVA|||||||0.009
91661594|NCT04278560|183217928|SUPERIORITY||Mean Difference (Net)|1.2||||0.03|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.03
91661595|NCT04278560|183217929|SUPERIORITY||Mean Difference (Net)|0.19||||0.4|TWO_SIDED||||||ANOVA|We used change from baseline for the analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.4
91661596|NCT04278560|183217930|SUPERIORITY||Mean Difference (Net)|3.1||||0.016|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.016
91481232|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3776|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at baseline via Chi-squared test||||0.3776
91661597|NCT04278560|183217931|SUPERIORITY||Mean Difference (Net)|9.94||||0.17|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.17
91481233|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.2856|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist post-intervention via Chi-squared test||||0.2856
91481234|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0016|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0016
91525086|NCT03324880|182925471|SUPERIORITY||Difference in LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.125|=|0.013|TWO_SIDED|95.0|-0.53|-0.04||1-sided p-value was reported.|MMRM|||Impact on Sleep|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.04|-0.53|=0.013
91661598|NCT04278560|183217932|SUPERIORITY||Median Difference (Net)|0.6||||0.1|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.1
91661599|NCT04278560|183217933|SUPERIORITY||Median Difference (Net)|0.07||||0.7|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline||||||0.7
91661600|NCT04278560|183217934|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91661601|NCT04278560|183217935|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
91661602|NCT03635320|183217981|NON_INFERIORITY|non-inferiority margin of -10%|95%CI|0.0|||||TWO_SIDED|95.0|-4.53|4.42|||Newcombe-Wilson scoring method|Using the Newcombe-Wilson scoring method, the difference of fracture union rate between the TFNA group and the PFNA-II group was 0.|If the lower limit of 95% CI of the difference in the rates of the study group and the control group is greater than the non-inferiority margin of -10%, then the investigational product is considered non-inferior to the control product.|||4.42|-4.53|
91661603|NCT02322593|183217990|SUPERIORITY||Hazard Ratio (HR)|0.83|STANDARD_ERROR_OF_MEAN|0.091||0.039|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.039
91661604|NCT02322593|183217991|SUPERIORITY||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.086||0.0045|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0045
91661605|NCT02322593|183217992|SUPERIORITY||Hazard Ratio (HR)|0.82|STANDARD_ERROR_OF_MEAN|0.078||0.011|TWO_SIDED|95.0|0.7|0.96|||Log Rank|||||0.96|0.70|0.011
91661606|NCT02322593|183217993|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91661607|NCT02322593|183217994|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
91661608|NCT03868891|183217995|OTHER|||||||1|||||||Wilcoxon signed-rank|||inflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||1.00
91661609|NCT03868891|183217995|OTHER|||||||0.734|||||||Wilcoxon signed-rank|||deflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||0.734
91661610|NCT03868891|183217996|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with baseline||||0.25
91661611|NCT03868891|183217996|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with baseline||||0.75
91661612|NCT03868891|183217997|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with 2 months||||0.25
91661613|NCT03868891|183217997|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with 2 months||||0.75
91661614|NCT04994535|183218029|SUPERIORITY||Difference (%)|30.9|||<|0.0001|TWO_SIDED|95.0|24.5|37.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.4|24.5|<.0001
91661615|NCT04994535|183218030|SUPERIORITY||Difference (%)|38.9|||<|0.0001|TWO_SIDED|95.0|31.3|46.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||46.4|31.3|<0.0001
91661616|NCT04994535|183218031|SUPERIORITY||Difference (%)|36.9|||<|0.0001|TWO_SIDED|95.0|29.1|44.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.7|29.1|<0.0001
91481235|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9449|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at baseline via Chi-squared test||||0.9449
91481236|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6143|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends post-intervention via Chi-squared test||||0.6143
91481237|NCT03239665|182835482|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0036|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0036
91481238|NCT03239665|182835483|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.|||||<|0.0001|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their doctor at one-month follow-up via Chi-squared test||||<0.0001
91481239|NCT03239665|182835483|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0012|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0012
91481240|NCT03239665|182835483|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0034|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0034
91623663|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.59|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-45.38|-35.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.79|-45.38|<0.001
91623664|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.0|-34.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.66|-46.00|<0.001
91623665|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.05|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-51.76|-42.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.35|-51.76|<0.001
91481241|NCT04777331|182835528|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0657|TWO_SIDED|95.0|0.69|1.01|||Log Rank|||Stratified Analysis||1.01|0.69|0.0657
91525087|NCT03324880|182925471|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.128|=|0.003|TWO_SIDED|95.0|-0.61|-0.11||1-sided p-value was reported.|MMRM|||Ability to Exercise|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.11|-0.61|=0.003
91661617|NCT04994535|183218034|SUPERIORITY||Difference (%)|50.2|||<|0.0001|TWO_SIDED|95.0|42.0|58.3||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.3|42.0|<.0001
91661618|NCT04994535|183218035|SUPERIORITY||Difference (%)|27.1|||<|0.0001|TWO_SIDED|95.0|18.1|36.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||36.1|18.1|<.0001
91661619|NCT04994535|183218036|SUPERIORITY||Difference (%)|35.8|||<|0.0001|TWO_SIDED|95.0|27.4|44.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.2|27.4|<.0001
91481242|NCT04777331|182835529|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0914|TWO_SIDED|95.0|0.66|1.03|||Cox-regression adjusted|||||1.03|0.66|0.0914
91481243|NCT04777331|182835530|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1574|TWO_SIDED|95.0|0.73|1.05|||Cox-regression adjusted|||||1.05|0.73|0.1574
91481244|NCT04777331|182835531|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0622|TWO_SIDED|95.0|0.69|1.01|||Cox-regression adjusted|||||1.01|0.69|0.0622
91481245|NCT04777331|182835532|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.5515|TWO_SIDED|95.0|0.75|1.17|||Cox-regression adjusted|||||1.17|0.75|0.5515
91481246|NCT04777331|182835533|SUPERIORITY||Difference in Adjusted Means|-0.39||||0.5944|TWO_SIDED|95.0|-1.84|1.05|||Mixed-model for Repeated Measures (MMRM)|||||1.05|-1.84|0.5944
91481247|NCT04777331|182835534|SUPERIORITY||Difference in Adjusted Means|0.08||||0.8955|TWO_SIDED|95.0|-1.08|1.24|||MMRM|||||1.24|-1.08|0.8955
91481248|NCT00400153|182835551|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liter|Mean Difference (Final Values)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0095||0.7135||95.0|-0.0222|0.0152|||ANCOVA|||||0.0152|-0.0222|0.7135
91481249|NCT00400153|182835552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.028|0.066|||ANCOVA|||||0.066|0.028|< 0.0001
91481250|NCT00400153|182835553|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liters|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.011||0.1389||95.0|-0.039|0.005|||ANCOVA|||||0.005|-0.039|0.1389
91623666|NCT01763866|183139965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.62|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-54.27|-42.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-42.98|-54.27|<0.001
91661620|NCT04994535|183218037|SUPERIORITY||Difference (SE)|-4.4|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-5.4|-3.4||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.4|-5.4|<.0001
91661621|NCT04994535|183218040|SUPERIORITY||Difference (%)|42.9|||<|0.0001|TWO_SIDED|95.0|34.8|51.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||51.0|34.8|<0.0001
91661622|NCT04994535|183218041|SUPERIORITY||Difference (%)|49.4|||<|0.0001|TWO_SIDED|95.0|40.8|58.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.1|40.8|<0.0001
91661623|NCT04994535|183218042|SUPERIORITY||Difference (%)|28.8|||<|0.0001|TWO_SIDED|95.0|19.4|38.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||38.2|19.4|<0.0001
91661624|NCT04994535|183218043|SUPERIORITY||Difference (%)|35.9|||<|0.0001|TWO_SIDED|95.0|27.2|44.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.6|27.2|<0.0001
91661625|NCT04994535|183218044|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-5.8|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.7|-5.8|<0.0001
91661626|NCT04994535|183218045|SUPERIORITY||Difference (SE)|-4.9|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-6.0|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-3.7|-6.0|<0.0001
91661627|NCT04994535|183218045|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.9|-3.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.6|-5.9|<0.0001
91661628|NCT04994535|183218045|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
91661629|NCT02246920|183218057|EQUIVALENCE|Equivalence is established if the 90% confidence interval is contained within 80.00-125.00%.|T/R Ls Mean Ratio|108.09|||||TWO_SIDED|90.0|94.09|124.4||||||||124.40|94.09|
91661630|NCT02246920|183218058|EQUIVALENCE|Equivalence is demonstrated when the 90% confidence interval is contained within 80.00-125.00%.|T/R LS Mean Ratio|107.0|||||TWO_SIDED|90.0|92.42|124.09||||||||124.09|92.42|
91661631|NCT02246920|183218059|SUPERIORITY|||||||0.0028|||||||ANCOVA|||||||0.0028
91661632|NCT02246920|183218059|SUPERIORITY|||||||0.0169|||||||ANCOVA|||||||0.0169
91661633|NCT00968812|183218101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.|Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.109|0.085|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||0.085|-0.109|
91661634|NCT00968812|183218101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride|Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.217|-0.023|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||-0.023|-0.217|
91661635|NCT00968812|183218102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.06|0.16|||Regression, Logistic|||||0.16|0.06|<0.001
91661636|NCT00968812|183218102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.001|TWO_SIDED|95.0|0.05|0.14|||Regression, Logistic|||||0.14|0.05|<0.001
91661637|NCT00968812|183218103|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-5.7|-4.7|||ANCOVA|||||-4.7|-5.7|<0.001
91661638|NCT00968812|183218103|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-6.2|-5.1|||ANCOVA|||||-5.1|-6.2|<0.001
91661639|NCT00968812|183218104|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.2|0.01|||ANCOVA|||||0.010|-0.200|
91661640|NCT00968812|183218104|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.289|-0.078|||ANCOVA|||||-0.078|-0.289|
91661641|NCT00834340|183218105|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
91661642|NCT00834340|183218106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|94.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.0|
91661643|NCT00834340|183218107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|98.7|
91661644|NCT00395694|183218108|SUPERIORITY_OR_OTHER||Percentage of participants|4.9|||||TWO_SIDED|95.0|1.6|11.1|||||The estimated value represents the percentage of participants with rash events.|||11.1|1.6|
91691906|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.8169||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.8169
91713740|NCT00737100|183319002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1418||95.0|-0.02|0.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||0.12|-0.02|0.1418
91623667|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.83|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-51.73|-41.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.94|-51.73|<0.001
91623668|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.86|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-48.43|-37.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.30|-48.43|<0.001
91623669|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.6|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-33.56|-23.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.65|-33.56|<0.001
91623670|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.22|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-35.74|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.70|-35.74|<0.001
91623671|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.66|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.54|-51.66|<0.001
91661645|NCT01940341|183218135|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 130 and 260 participants in the TDF group and TAF groups, respectively were planned to give 90% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size was based on the assumption that the expected difference (TAF-TDF) in proportion of participants with HBV DNA\<29 IU/mL was 0 and the proportion of participants with HBV DNA\<29 IU/mL in the TDF group was 91%. All missing data were treated as not achieving the primary endpoint.|Difference in proportions|1.8|||||TWO_SIDED|95.0|-3.6|7.2|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||7.2|-3.6|
91661646|NCT01935934|183218141|OTHER||||||||||||||||||"Trial design discriminated between co-primary endpoints of objective RR of 30% (vs 10%) and 12-week PFS of 55% (vs 30%). The design had 86% power to detect a true objective RR of at least 30% and at least 90% power to detect a true 12-week PFS rate of atleast 55% (or a median PFS of 3.4 months).~The parallel exploratory cohort of uncommon histology cancers was analyzed independently."|||
91481251|NCT00400153|182835554|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.124||95.0|-0.036|0.004|||ANCOVA|||||0.004|-0.036|0.124
91623672|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.43|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-49.01|-35.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.85|-49.01|<0.001
91661647|NCT03134222|183218194|SUPERIORITY|||||||0.75|||||||Mixed-effect repeated measures model|||||||0.7500
91661648|NCT03134222|183218194|SUPERIORITY|||||||0.3047|||||||Mixed-effect repeated measures model|||||||0.3047
91661649|NCT03134222|183218195|SUPERIORITY|||||||0.8869|||||||Cochran-Mantel-Haenszel|||||||0.8869
91661650|NCT03134222|183218195|SUPERIORITY|||||||0.3293|||||||Cochran-Mantel-Haenszel|||||||0.3293
91661651|NCT03134222|183218196|SUPERIORITY|||||||0.7456|||||||Cochran-Mantel-Haenszel|||||||0.7456
91481252|NCT00400153|182835555|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.4888||95.0|-0.026|0.013|||ANCOVA|||||0.013|-0.026|0.4888
91481253|NCT00400153|182835556|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.014||||0.1433||95.0|-0.033|0.005|||ANCOVA|||||0.005|-0.033|0.1433
91481254|NCT00400153|182835557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.083|||ANCOVA|||This analysis is purely exploratory.||0.083|0.04|< 0.0001
91623673|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.26|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-36.68|-23.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.84|-36.68|<0.001
91623674|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.19|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-31.79|-18.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.59|-31.79|<0.001
91623675|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.25|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-48.77|-37.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.74|-48.77|<0.001
91661652|NCT03134222|183218196|SUPERIORITY|||||||0.6407|||||||Cochran-Mantel-Haenszel|||||||0.6407
91661653|NCT03134222|183218197|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
91661654|NCT03134222|183218197|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
91661655|NCT03134222|183218198|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
91661656|NCT03134222|183218198|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
91661657|NCT03482882|183218208|OTHER||LSM|-10.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-12.0|-9.5|||Mixed-effect model repeated measures|||||-9.5|-12.0|<0.0001
91661658|NCT00520234|183218216|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Cochran-Mantel-Haenszel|APACHE II Stratified||||||0.14
91661659|NCT01085825|183218227|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||.13
91661660|NCT05152576|183218239|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
91661661|NCT05152576|183218239|SUPERIORITY||Rate Difference|38.2|||<|0.001|TWO_SIDED|95.0|19.2|57.1||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||57.1|19.2|<0.001
91661662|NCT05152576|183218239|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
91661663|NCT00859430|183218240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|105.0||||||90.0|98.6|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|98.6|
91661664|NCT00859430|183218241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|96.2|
91661665|NCT00859430|183218242|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|95.9|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|95.9|
91661666|NCT00834795|183218247|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|95.16||||||90.0|85.69|105.67|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.67|85.69|
91661667|NCT00834795|183218248|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.27||||||90.0|90.34|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.59|90.34|
91661668|NCT00834795|183218249|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.36||||||90.0|90.2|102.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.93|90.20|
91661669|NCT00238615|183218259|SUPERIORITY_OR_OTHER||probability of survival at 2 years|0.72|STANDARD_DEVIATION|0.0|||TWO_SIDED|95.0|0.36|0.9||The primary endpoint of 2 year overall survival was (0.72) = 72%||||2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.||0.90|0.36|
91661670|NCT02718326|183218267|SUPERIORITY||percentage difference|52.3|||<|0.0001|TWO_SIDED|95.0|45.2|59.5|||Cochran-Mantel-Haenszel|||||59.5|45.2|<0.0001
91661671|NCT02718326|183218268|SUPERIORITY||percentage difference|50.1|||<|0.0001|TWO_SIDED|95.0|40.1|60.1|||Cochran-Mantel-Haenszel|||||60.1|40.1|<0.0001
91661672|NCT02718326|183218268|SUPERIORITY||percentage difference|64.8|||<|0.0001|TWO_SIDED|95.0|55.8|73.9|||Cochran-Mantel-Haenszel|||||73.9|55.8|< 0.0001
91661673|NCT02718326|183218269|SUPERIORITY||percentage difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-24.7|-9.9|||Cochran-Mantel-Haenszel|||||-9.9|-24.7|<0.0001
91661674|NCT02718326|183218269|SUPERIORITY||percentage difference|-16.6|||<|0.0001|TWO_SIDED|95.0|-24.2|-9.1|||Cochran-Mantel-Haenszel|||||-9.1|-24.2|<0.0001
91661675|NCT02718326|183218270|SUPERIORITY||percentage difference|-17.3|||=|0.0002|TWO_SIDED|95.0|-26.2|-8.5|||Cochran-Mantel-Haenszel|||||-8.5|-26.2|= 0.0002
91661676|NCT02718326|183218270|SUPERIORITY||percentage difference|-18.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-10.4|||Cochran-Mantel-Haenszel|||||-10.4|-27.5|<0.0001
91481255|NCT00400153|182835558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.024|0.065|||ANCOVA|||This analysis is purely exploratory.||0.065|0.024|< 0.0001
91661677|NCT02718326|183218273|SUPERIORITY||percentage difference|-6.0||||0.0096|TWO_SIDED|95.0|-10.5|-1.5|||Cochran-Mantel-Haenszel|||||-1.5|-10.5|0.0096
91661678|NCT02718326|183218273|SUPERIORITY||percentage difference|-6.0||||0.0089|TWO_SIDED|95.0|-10.5|-1.6|||Cochran-Mantel-Haenszel|||||-1.6|-10.5|0.0089
91661679|NCT02718326|183218274|SUPERIORITY||Estimate for contrast|0.8||||0.0529|TWO_SIDED|95.0|-0.01|1.6|||ANOVA|||||1.60|-0.01|0.0529
91661680|NCT02718326|183218274|SUPERIORITY||Estimate for contrast|1.14||||0.0057|TWO_SIDED|95.0|0.33|1.94|||ANOVA|||||1.94|0.33|0.0057
91661681|NCT00761813|183218281|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.63|1.09||||||||1.09|.63|
91661682|NCT00761813|183218282|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91661683|NCT03049748|183218283|OTHER|This is a pilot randomized trial with a purpose of establishing preliminary efficacy data to inform future studies.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91661684|NCT03049748|183218284|OTHER|Same rationale as the primary outcome.|||||>|0.05||||||All p-values across time periods, between groups, were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
91661685|NCT03049748|183218285|OTHER||||||>|0.05||||||All p values between groups across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
91661686|NCT03049748|183218286|OTHER||||||>|0.05||||||All p-values between groups across time periods were \>.05|Wilcoxon (Mann-Whitney)|||||||>.05
91661687|NCT03049748|183218287|OTHER||||||>|0.05||||||All p-values between group differences across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
91481256|NCT00400153|182835559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.027|0.067|||ANCOVA|||This analysis is purely exploratory.||0.067|0.027|< 0.0001
91623676|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.33|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.04|-39.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.61|-51.04|<0.001
91623677|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.13|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-46.65|-35.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.61|-46.65|<0.001
91623678|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-41.72|-28.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.25|-41.72|<0.001
91623679|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.04|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-51.83|-42.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.25|-51.83|<0.001
91623680|NCT01763866|183139966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-50.67|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-38.54|-50.67|<0.001
91623681|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.97|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-64.91|-55.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.03|-64.91|<0.001
91623682|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.11|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-59.57|-48.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.64|-59.57|<0.001
91623683|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-42.8|-32.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.77|-42.80|<0.001
91623684|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.86|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-47.34|-36.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.67|-47.34|<0.001
91661688|NCT03049748|183218288|OTHER|||||||0.05||||||Differences in group hospitalization rates p-values: T1 = .093; T2 = .008; T3 = .029|Wilcoxon (Mann-Whitney)|||||||0.05
91691907|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.4||0.9359|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.9359
91481257|NCT00400153|182835560|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0258||95.0|0.003|0.049|||ANCOVA|||||0.049|0.003|0.0258
91623685|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.9|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-64.22|-49.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.59|-64.22|<0.001
91623686|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.99|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-68.68|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.29|-68.68|<0.001
91623687|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.26|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-44.48|-30.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.04|-44.48|<0.001
91623688|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.29|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-50.07|-36.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.51|-50.07|<0.001
91623689|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.29|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-60.79|-49.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.79|-60.79|<0.001
91623690|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|-64.16|-54.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.32|-64.16|<0.001
91623691|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.63|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-56.82|-44.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.45|-56.82|<0.001
91623692|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.78|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-63.91|-49.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.64|-63.91|<0.001
91623693|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-62.51|-52.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.99|-62.51|<0.001
91623694|NCT01763866|183139967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.06|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-61.85|-50.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.27|-61.85|<0.001
91661689|NCT01011413|183218297|NON_INFERIORITY|"Only the primary endpoint is assessed in terms of non-inferiority. All other comparisons are tests for superiority and are considered statistically significant at a two-sided alpha=0.05.~Non-inferiority of EFV 400 mg was defined as the lower 95% confidence interval (CI) of the difference between groups in the proportion of viral load below 200 copies/mL at week 48 lying above -10%."||||||0.05||||||No adjustments were made for multiple comparisons|Pearson's chi-squared|Pearson's chi-squared or Fisher's exact test derived p value was used||Sample size calculation assumes 85% of participants randomised to 600mg EFV arm will have plasma HIV RNA \<200 copies/ml at 48 weeks. Assuming no difference between randomised treatments in proportion with plasma HIV RNA \<200 copies/mL, to have 90% power to demonstrate non-inferiority in the intention to treat (ITT) analysis using a 10% non-inferiority margin will require 286 participants per arm, making a total of 572 participants. Power for modified ITT analysis was 93%.||||0.05
91623695|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.29|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-65.65|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.65|<0.001
91623696|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.44|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-54.23|-42.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.65|-54.23|<0.001
91661690|NCT01011413|183218297|NON_INFERIORITY|Non-inferiority will be defined as the lower 95% confidence limit of the difference in percentages of patients with undetectable viral load lying above -10% (i.e. a non-inferiority margin of 10%).||||||0.05||||||No adjustment for multiple comparisons|Chi-squared|||To ensure the per protocol (PP) analysis has 90% power to demonstrate non-inferiority, the sample size was inflated for patients who switch treatment for toxicity. This is estimated to be no more than 10% randomised patients. To ensure 90% power to demonstrate non-inferiority in the ITT and PP analyses, a total of 630 (315 per arm) patients will be randomised giving 93% power for the ITT analysis. Null hypothesis: no statistically significant difference between the 600mg and 400mg EFV regimens.||||0.05
91623697|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.66|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-45.09|-34.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.23|-45.09|<0.001
91623698|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.32|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-43.12|-31.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.52|-43.12|<0.001
91623699|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.77|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|95.0|-65.55|-49.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.99|-65.55|<0.001
91623700|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.26|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-64.91|-49.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.60|-64.91|<0.001
91661691|NCT01011413|183218298|SUPERIORITY_OR_OTHER_LEGACY||difference between proportions|0.05||||0.05|TWO_SIDED|95.0||||P-value not adjusted for multiple comparisons|Chi-squared|||||||0.05
91623701|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.9|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-47.53|-32.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.26|-47.53|<0.001
91623702|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-46.26|-30.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.88|-46.26|<0.001
91623703|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.41|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-59.99|-48.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.82|-59.99|<0.001
91623704|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.13|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-61.58|-50.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.68|-61.58|<0.001
91661692|NCT00462228|183218324|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.55
91661693|NCT00462228|183218324|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||1.00
91661694|NCT00462228|183218324|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.45
91661695|NCT00462228|183218324|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||0.43
91623705|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.17|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-55.8|-42.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.53|-55.80|<0.001
91623706|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-57.21|-40.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.40|-57.21|<0.001
91623707|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-62.82|-52.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.65|-62.82|<0.001
91623708|NCT01763866|183139968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.04|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-58.1|-45.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-45.98|-58.10|<0.001
91623709|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|70.2|88.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.5|70.2|<0.001
91623710|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.3|||<|0.001|TWO_SIDED|95.0|67.9|86.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||86.8|67.9|<0.001
91661696|NCT00462228|183218325|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||6 week comparison,alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores||||0.23
91661697|NCT00462228|183218325|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.022
91661698|NCT00462228|183218325|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores.||||0.06
91661699|NCT00462228|183218325|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.027
91661700|NCT00462228|183218326|SUPERIORITY_OR_OTHER|||||||1||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||1.0
91661701|NCT00462228|183218326|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.55
91481258|NCT00400153|182835561|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.011||0.3749||95.0|-0.032|0.012|||ANCOVA|||||0.012|-0.032|0.3749
91623711|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.1|||<|0.001|TWO_SIDED|95.0|53.1|78.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||78.1|53.1|<0.001
91623712|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|69.2|||<|0.001|TWO_SIDED|95.0|54.8|78.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||78.5|54.8|<0.001
91623713|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.7|||<|0.001|TWO_SIDED|95.0|67.3|88.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.3|67.3|<0.001
91623714|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.3|||<|0.001|TWO_SIDED|95.0|70.7|89.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.6|70.7|<0.001
91623715|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|29.5|56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||56.7|29.5|<0.001
91623716|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|30.3|||<|0.001|TWO_SIDED|95.0|16.7|44.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||44.2|16.7|<0.001
91623717|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.7|||<|0.001|TWO_SIDED|95.0|69.5|88.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.0|69.5|<0.001
91623718|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|73.1|90.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.2|73.1|<0.001
91623719|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|54.6|||<|0.001|TWO_SIDED|95.0|39.8|66.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||66.9|39.8|<0.001
91623720|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.7|||<|0.001|TWO_SIDED|95.0|51.0|76.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||76.6|51.0|<0.001
91623721|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|91.7|||<|0.001|TWO_SIDED|95.0|81.6|95.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.3|81.6|<0.001
91623722|NCT01763866|183139969|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|72.8|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.0|72.8|<0.001
91623723|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.5|||<|0.001|TWO_SIDED|95.0|71.9|89.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.2|71.9|<0.001
91481259|NCT00400153|182835562|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.3355||95.0|-0.033|0.011|||ANCOVA|||||0.011|-0.033|0.3355
91623724|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.3|||<|0.001|TWO_SIDED|95.0|65.2|85.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.3|65.2|<0.001
91623725|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|47.3|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||73.9|47.3|<0.001
91481260|NCT00400153|182835563|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.0743||95.0|-0.042|0.002|||ANCOVA|||||0.002|-0.042|0.0743
91481261|NCT00400153|182835564|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.011||0.5711||95.0|-0.015|0.028|||ANCOVA|||||0.028|-0.015|0.5711
91481262|NCT00400153|182835565|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.011||0.2274||95.0|-0.033|0.008|||ANCOVA|||||0.008|-0.033|0.2274
91481263|NCT00400153|182835566|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8065||95.0|-0.018|0.024|||ANCOVA|||||0.024|-0.018|0.8065
91481264|NCT00400153|182835567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.043|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.043|< 0.0001
91661702|NCT00462228|183218326|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||0.81
91661703|NCT00462228|183218326|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.57
91661704|NCT00462228|183218327|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.55
91661705|NCT00462228|183218327|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||1.0
91661706|NCT00462228|183218327|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.17
91661707|NCT00462228|183218327|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||0.64
91481265|NCT00400153|182835568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.044|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.044|< 0.0001
91481266|NCT00400153|182835569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.081|||ANCOVA|||This analysis is purely exploratory.||0.081|0.04|< 0.0001
91661708|NCT00462228|183218328|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R total recall scores.||||0.34
91661709|NCT00462228|183218328|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||1.0
91661710|NCT00462228|183218328|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall scores.||||0.54
91661711|NCT00462228|183218328|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||0.91
91661712|NCT00462228|183218329|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.34
91661713|NCT00462228|183218329|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.55
91481267|NCT00400153|182835570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.047|0.089|||ANCOVA|||This analysis is purely exploratory.||0.089|0.047|< 0.0001
91481268|NCT00400153|182835583|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.021||0.417||95.0|-0.058|0.024|||ANCOVA|||||0.024|-0.058|0.417
91481269|NCT00400153|182835584|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3505||95.0|-0.059|0.021|||ANCOVA|||||0.021|-0.059|0.3505
91481270|NCT00400153|182835585|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3499||95.0|-0.058|0.021|||ANCOVA|||||0.021|-0.058|0.3499
91481271|NCT00400153|182835586|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.8288||95.0|-0.044|0.035|||ANCOVA|||||0.035|-0.044|0.8288
91481272|NCT00400153|182835587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.069|0.154|||ANCOVA|||This analysis is purely exploratory.||0.154|0.069|< 0.0001
91481273|NCT00400153|182835588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.049|0.132|||ANCOVA|||This analysis is purely exploratory.||0.132|0.049|< 0.0001
91481274|NCT00400153|182835589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.056|0.138|||ANCOVA|||This analysis is purely exploratory.||0.138|0.056|< 0.0001
91481275|NCT00400153|182835590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.054|0.135|||ANCOVA|||This analysis is purely exploratory.||0.135|0.054|< 0.0001
91481276|NCT00400153|182835591|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.024||0.0688||95.0|-0.003|0.09|||ANCOVA|||||0.09|-0.003|0.0688
91661714|NCT00462228|183218329|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.37
91713741|NCT00737100|183319003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.8515||95.0|0.37|1.72|||Regression, Logistic|Covariates of treatment and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||1.72|0.37|0.8515
91713742|NCT00737100|183319003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.5565||95.0|0.33|1.59|||Regression, Logistic|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||1.59|0.33|0.5565
91713743|NCT03113968|183319072|NON_INFERIORITY|The Farrington-Manning score test was used to assess the noninferiority of KET.|||||<|0.001|||||||The Farrington-Manning score test|||||||<.001
91481277|NCT00400153|182835592|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.023||0.3895||95.0|-0.064|0.025|||ANCOVA|||||0.025|-0.064|0.3895
91481278|NCT00400153|182835593|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.022||0.959||95.0|-0.045|0.042|||ANCOVA|||||0.042|-0.045|0.959
91525088|NCT03324880|182925471|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.123|=|0.002|TWO_SIDED|95.0|-0.61|-0.12||1-sided p-value was reported.|MMRM|||Ability to Complete Work|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.12|-0.61|=0.002
91623726|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.9|||<|0.001|TWO_SIDED|95.0|49.8|75.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||75.2|49.8|<0.001
91623727|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.1|||<|0.001|TWO_SIDED|95.0|65.8|87.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.9|65.8|<0.001
91623728|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.2|||<|0.001|TWO_SIDED|95.0|67.9|88.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.1|67.9|<0.001
91623729|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.1|||<|0.001|TWO_SIDED|95.0|26.4|55.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||55.1|26.4|<0.001
91623730|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|35.2|||<|0.001|TWO_SIDED|95.0|20.7|49.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||49.3|20.7|<0.001
91623731|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|77.3|||<|0.001|TWO_SIDED|95.0|63.9|84.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||84.7|63.9|<0.001
91623732|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.1|||<|0.001|TWO_SIDED|95.0|68.8|87.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.5|68.8|<0.001
91623733|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|52.7|||<|0.001|TWO_SIDED|95.0|37.6|65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||65.3|37.6|<0.001
91713744|NCT03113968|183319073|SUPERIORITY||Mean Difference (Net)|9.3|||||TWO_SIDED||||||||||P-values not reported|||
91713745|NCT04805671|183319074|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
91713746|NCT04805671|183319079|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
91713747|NCT04805671|183319080|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
91481279|NCT00400153|182835594|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.023||0.7652||95.0|-0.053|0.039|||ANCOVA|||||0.039|-0.053|0.7652
91481280|NCT00400153|182835595|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.023||0.6244||95.0|-0.057|0.034|||ANCOVA|||||0.034|-0.057|0.6244
91481281|NCT00400153|182835596|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.023||0.873||95.0|-0.041|0.049|||ANCOVA|||||0.049|-0.041|0.873
91481282|NCT00400153|182835597|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.023||0.5294||95.0|-0.06|0.031|||ANCOVA|||||0.031|-0.06|0.5294
91623734|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.3|||<|0.001|TWO_SIDED|95.0|49.1|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||75.5|49.1|<0.001
91623735|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|92.5|||<|0.001|TWO_SIDED|95.0|82.3|95.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.9|82.3|<0.001
91623736|NCT01763866|183139970|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.4|||<|0.001|TWO_SIDED|95.0|64.9|85.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.4|64.9|<0.001
91623737|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.08|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-39.06|-25.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.11|-39.06|<0.001
91623738|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.86|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-29.7|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.03|-29.70|<0.001
91623739|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.45|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|-34.53|-20.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.38|-34.53|<0.001
91623740|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.49|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-37.36|-21.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.62|-37.36|<0.001
91623741|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.52|STANDARD_ERROR_OF_MEAN|3.65|<|0.001|TWO_SIDED|95.0|-27.71|-13.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.33|-27.71|<0.001
91623742|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.96|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-37.01|-20.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.92|-37.01|<0.001
91623743|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.02|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-39.11|-24.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.93|-39.11|<0.001
91623744|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.42|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-45.61|-29.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.23|-45.61|<0.001
91623745|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.66|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-42.94|-28.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.38|-42.94|<0.001
91481283|NCT00400153|182835598|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.023||0.563||95.0|-0.032|0.058|||ANCOVA|||||0.058|-0.032|0.563
91623746|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-35.36|-18.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.27|-35.36|<0.001
91623747|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.56|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-40.74|-26.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.37|-40.74|<0.001
91623748|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.19|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-40.8|-23.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.58|-40.80|<0.001
91623749|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.07|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-34.91|-21.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.23|-34.91|<0.001
91623750|NCT01763866|183139971|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-34.59|-19.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.73|-34.59|<0.001
91623751|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-40.81|-25.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.60|-40.81|<0.001
91661715|NCT00462228|183218329|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.95
91661716|NCT00462228|183218330|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.75
91481284|NCT00400153|182835599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.075|0.167|||ANCOVA|||This analysis is purely exploratory.||0.167|0.075|< 0.0001
91481285|NCT00400153|182835600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.084|0.174|||ANCOVA|||This analysis is purely exploratory.||0.174|0.084|< 0.0001
91481286|NCT00400153|182835601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.072|0.163|||ANCOVA|||This analysis is purely exploratory.||0.163|0.072|< 0.0001
91481287|NCT00400153|182835602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.171|||ANCOVA|||This analysis is purely exploratory.||0.171|0.081|< 0.0001
91481288|NCT00400153|182835607|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.00045|STANDARD_ERROR_OF_MEAN|0.06396||0.9943||95.0|-0.1259|0.125|||ANCOVA|||||0.125|-0.1259|0.9943
91623752|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.82|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-27.92|-11.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.72|-27.92|<0.001
91661717|NCT00462228|183218330|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.51
91722484|NCT03881371|183337726|SUPERIORITY||Least-Square Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|-1.643|-0.555||"Analysis was based on a covariance model (ANCOVA) with treatment and centre as independent factors, baseline mean total daily OFF time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.555|-1.643|<.0001
91481289|NCT00400153|182835607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01995|STANDARD_ERROR_OF_MEAN|0.06441||0.7569|TWO_SIDED|95.0|-0.1463|0.1064|||ANCOVA|||This analysis is purely exploratory.||0.1064|-0.1463|0.7569
91481290|NCT00400153|182835608|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.1091|STANDARD_ERROR_OF_MEAN|0.1206||0.3659||95.0|-0.1276|0.3458|||ANCOVA|||||0.3458|-0.1276|0.3659
91481291|NCT00400153|182835608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1554|STANDARD_ERROR_OF_MEAN|0.122||0.203|TWO_SIDED|95.0|-0.3947|0.08395|||ANCOVA|||This analysis is purely exploratory.||0.08395|-0.3947|0.203
91481292|NCT00400153|182835609|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.007734|STANDARD_ERROR_OF_MEAN|0.03199||0.809||95.0|-0.05503|0.0705|||ANCOVA|||||0.0705|-0.05503|0.809
91481293|NCT00400153|182835609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06501|STANDARD_ERROR_OF_MEAN|0.03225||0.044|TWO_SIDED|95.0|0.001746|0.1283|||ANCOVA|||This analysis is purely exploratory.||0.1283|0.001746|0.044
91481294|NCT00400153|182835610|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.0129|STANDARD_ERROR_OF_MEAN|0.03002||0.6674||95.0|-0.04598|0.07179|||ANCOVA|||||0.07179|-0.04598|0.6674
91481295|NCT00400153|182835610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01573|STANDARD_ERROR_OF_MEAN|0.03033||0.604|TWO_SIDED|95.0|-0.04376|0.07523|||ANCOVA|||This analysis is purely exploratory.||0.07523|-0.04376|0.604
91481296|NCT00400153|182835611|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|1.6526|STANDARD_ERROR_OF_MEAN|2.0653||0.4238||95.0|-2.3995|5.7047|||ANCOVA|||||5.7047|-2.3995|0.4238
91661718|NCT00462228|183218330|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.31
91661719|NCT00462228|183218330|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.46
91661720|NCT00462228|183218331|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.34
91661721|NCT00462228|183218331|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.75
91661722|NCT00462228|183218331|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.37
91661723|NCT00462228|183218331|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.45
91661724|NCT00567320|183218332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|TWO_SIDED|95.0|||||Mixed Models Analysis|||HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.||||0.84
91661725|NCT01299454|183218333|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.166|||||TWO_SIDED|90.0|0.776|1.751|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.751|0.776|
91661726|NCT01299454|183218333|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.375|||||TWO_SIDED|90.0|0.915|2.066|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.066|0.915|
91661727|NCT01299454|183218333|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.929|||||TWO_SIDED|90.0|0.581|1.488|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.488|0.581|
91481297|NCT00400153|182835611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4376|STANDARD_ERROR_OF_MEAN|2.0874||0.2431|TWO_SIDED|95.0|-1.6578|6.533|||ANCOVA|||This analysis is purely exploratory.||6.533|-1.6578|0.2431
91481298|NCT00400153|182835612|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.056||0.173||95.0|-0.034|0.187|||ANCOVA|||||0.187|-0.034|0.173
91481299|NCT00400153|182835612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.056||0.336|TWO_SIDED|95.0|-0.165|0.056|||ANCOVA|||This analysis is purely exploratory.||0.056|-0.165|0.336
91481300|NCT00400153|182835613|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.924||95.0|-0.115|0.127|||ANCOVA|||||0.127|-0.115|0.924
91481301|NCT00400153|182835613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.062||0.266|TWO_SIDED|95.0|-0.19|0.053|||ANCOVA|||This analysis is purely exploratory.||0.053|-0.19|0.266
91481302|NCT00400153|182835614|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.065||0.139||95.0|-0.031|0.225|||ANCOVA|||||0.225|-0.031|0.139
91525089|NCT03324880|182925471|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.121|=|0.002|TWO_SIDED|95.0|-0.61|-0.13||1-sided p-value was reported.|MMRM|||Impact Family Relationships|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.13|-0.61|=0.002
91481303|NCT00400153|182835614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.066||0.788|TWO_SIDED|95.0|-0.111|0.146|||ANCOVA|||This analysis is purely exploratory.||0.146|-0.111|0.788
91481304|NCT00400153|182835619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91481305|NCT00400153|182835620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.482|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
91481306|NCT00400153|182835621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.612|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
91481307|NCT00400153|182835622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.508|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
91481308|NCT00400153|182835623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91481309|NCT00400153|182835624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91481310|NCT00400153|182835625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91661728|NCT01299454|183218334|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.255|||||TWO_SIDED|90.0|0.702|2.244|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.244|0.702|
91481311|NCT00400153|182835626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91623753|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.16|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-36.87|-21.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.44|-36.87|<0.001
91623754|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.44|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.56|-19.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.32|-35.56|<0.001
91623755|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.38|STANDARD_ERROR_OF_MEAN|4.07|<|0.001|TWO_SIDED|95.0|-30.39|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.36|-30.39|<0.001
91623756|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.1|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-36.62|-19.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.58|-36.62|<0.001
91623757|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.62|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-40.46|-24.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.78|-40.46|<0.001
91623758|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.88|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-43.52|-26.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.25|-43.52|<0.001
91623759|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.5|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-44.69|-28.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.30|-44.69|<0.001
91713748|NCT04805671|183319081|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
91623760|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.34|STANDARD_ERROR_OF_MEAN|4.48|<|0.001|TWO_SIDED|95.0|-34.19|-16.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.49|-34.19|<0.001
91713749|NCT04805671|183319082|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.0938|TWO_SIDED|95.0|0.964|1.586|||Regression, Cox|||ADG20 vs. Placebo||1.586|0.964|0.0938
91713750|NCT04805671|183319083|SUPERIORITY||Hazard Ratio (HR)|0.137||||0.0361|TWO_SIDED|95.0|0.016|1.162|||Regression, Cox|||ADG20 vs Placebo||1.162|0.016|0.0361
91713751|NCT04805671|183319084|SUPERIORITY||Hazard Ratio (HR)|1.255||||0.0781|TWO_SIDED|95.0|0.974|1.617|||Regression, Cox|||ADG20 vs Placebo||1.617|0.974|0.0781
91713752|NCT04805671|183319085|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.4976|TWO_SIDED|95.0|-0.66|0.32|||ANCOVA|||ADG20 vs. Placebo||0.32|-0.66|0.4976
91713753|NCT04805671|183319086|SUPERIORITY||Hazard Ratio (HR)|1.048||||0.7239|TWO_SIDED|95.0|0.806|1.364|||Regression, Cox|||||1.364|0.806|0.7239
91713754|NCT04805671|183319087|SUPERIORITY||Risk Difference (RD)|-11.1||||0.0364|TWO_SIDED|95.0|-21.42|-0.7|||Regression, Logistic|||||-0.70|-21.42|0.0364
91481312|NCT00400153|182835627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91481313|NCT00400153|182835628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
91623761|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.48|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-43.95|-29.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.02|-43.95|<0.001
91623762|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.17|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-42.61|-21.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.74|-42.61|<0.001
91661729|NCT01299454|183218334|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.977|3.052|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||3.052|0.977|
91661730|NCT01299454|183218334|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.041|||||TWO_SIDED|90.0|0.506|2.142|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||2.142|0.506|
91661731|NCT01299454|183218335|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.707|1.156|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.156|0.707|
91661732|NCT01299454|183218335|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.665|1.087|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.087|0.665|
91661733|NCT01299454|183218335|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.531||||||90.0|0.399|0.705|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||0.705|0.399|
91713755|NCT04805671|183319088|SUPERIORITY||Risk Difference (RD)|8.2||||0.0227|TWO_SIDED|95.0|1.15|15.31||The p-value and risk difference reported was calculated based on the Day 5 timepoint.|Regression, Logistic|||||15.31|1.15|0.0227
91713756|NCT04805671|183319089|SUPERIORITY||Mean Difference (Final Values)|-6.93||||0.1124|TWO_SIDED|95.0|-15.49|1.64|||ANCOVA|||||1.64|-15.49|0.1124
91713757|NCT03804268|183319096|SUPERIORITY||Percentage Difference|22.5|||<|0.0001|TWO_SIDED|95.0|14.3|30.8||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||30.8|14.3|<0.0001
91713758|NCT03804268|183319097|SUPERIORITY||Percentage Difference|9.7||||0.0114|TWO_SIDED|95.0|2.3|17.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||17.0|2.3|0.0114
91713759|NCT03804268|183319098|SUPERIORITY||Percentage Difference|2.1||||1|TWO_SIDED|95.0|-4.4|8.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||8.5|-4.4|1.0000
91527725|NCT01976364|182930501|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91713760|NCT03804268|183319099|SUPERIORITY||Least Square (LS) Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.72||0.0114|TWO_SIDED|95.0|3.7|6.5||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||6.5|3.7|0.0114
91713761|NCT03804268|183319100|SUPERIORITY||Percentage Difference|18.7||||0.0114|TWO_SIDED|95.0|10.6|26.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval was calculated based on normal approximation based on pooled variance without continuity correction.|||26.7|10.6|0.0114
91661734|NCT01299454|183218336|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.103|||||TWO_SIDED|90.0|0.774|1.573|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.573|0.774|
91661735|NCT01299454|183218336|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|0.841|1.71|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.710|0.841|
91661736|NCT01299454|183218336|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.524|1.189|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.189|0.524|
91713762|NCT03804268|183319101|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.14||0.0114|TWO_SIDED|95.0|0.6|1.1||Analysis of covariance (ANCOVA) was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.6|0.0114
91713763|NCT03804268|183319102|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.55||0.0114|TWO_SIDED|95.0|2.4|4.6||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||4.6|2.4|0.0114
91713764|NCT03804268|183319103|SUPERIORITY||Percentage Difference|-1.1||||1|TWO_SIDED|95.0|-7.1|5.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||5.0|-7.1|1.0000
91481314|NCT01423604|182835637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.733||||0.0494|TWO_SIDED|95.0|0.506|1.061||One-sided p-value.|Log Rank|||||1.061|0.506|0.0494
91481315|NCT01423604|182835637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0081|TWO_SIDED|95.0|0.281|0.888||One-sided p-value.|Log Rank|||Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) \> 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis||0.888|0.281|0.0081
91481316|NCT01423604|182835638|SUPERIORITY_OR_OTHER||Efron approximation of hazard ratio|0.75||||0.134|TWO_SIDED|95.0|0.513|1.094||Two-sided p-value.|Cox proportional hazards model|||||1.094|0.513|0.1340
91623763|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.25|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-38.4|-24.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.10|-38.40|<0.001
91623764|NCT01763866|183139972|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.17|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-36.79|-19.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.55|-36.79|<0.001
91623765|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.1|STANDARD_ERROR_OF_MEAN|4.83||0.2|TWO_SIDED|95.0|-21.63|-2.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.58|-21.63|0.20
91623766|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.55|STANDARD_ERROR_OF_MEAN|5.36||0.003|TWO_SIDED|95.0|-33.13|-11.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.97|-33.13|0.003
91481317|NCT01423604|182835640|SUPERIORITY_OR_OTHER|||||||0.0236|||||||Pearson's chi-square test|||||||0.0236
91481318|NCT05494632|182835650|SUPERIORITY||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|||||the threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91481319|NCT00403403|182835736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0097||95.0|0.323|0.862|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.862|0.323|0.0097
91481320|NCT00403403|182835737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6054|TWO_SIDED|95.0|0.66|2.039|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||2.039|0.660|0.6054
91623767|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.45|STANDARD_ERROR_OF_MEAN|4.89||1|TWO_SIDED|95.0|-12.09|7.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.19|-12.09|1.00
91623768|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.95|STANDARD_ERROR_OF_MEAN|5.33||0.053|TWO_SIDED|95.0|-25.46|-4.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.44|-25.46|0.053
91623769|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.43|STANDARD_ERROR_OF_MEAN|4.89||0.073|TWO_SIDED|95.0|-25.06|-5.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.79|-25.06|0.073
91623770|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.41|STANDARD_ERROR_OF_MEAN|5.32||0.027|TWO_SIDED|95.0|-24.9|-3.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.92|-24.90|0.027
91623771|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.17|STANDARD_ERROR_OF_MEAN|4.8||1|TWO_SIDED|95.0|-10.63|8.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.30|-10.63|1.00
91623772|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.51|STANDARD_ERROR_OF_MEAN|5.38||0.63|TWO_SIDED|95.0|-12.12|9.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.11|-12.12|0.63
91623773|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.72|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-32.9|-12.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.54|-32.90|<0.001
91623774|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.52|STANDARD_ERROR_OF_MEAN|5.69||0.007|TWO_SIDED|95.0|-30.76|-8.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.28|-30.76|0.007
91623775|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-17.59|STANDARD_ERROR_OF_MEAN|4.62||0.002|TWO_SIDED|95.0|-26.71|-8.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.46|-26.71|0.002
91623776|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.18|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-35.76|-16.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.59|-35.76|<0.001
91623777|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.38|-9.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.55|-32.38|<0.001
91623778|NCT01763866|183139973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.71|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.84|-18.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.57|-40.84|<0.001
91623779|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.06|STANDARD_ERROR_OF_MEAN|6.41||0.2|TWO_SIDED|95.0|-24.69|0.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||0.57|-24.69|0.20
91623780|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.6|STANDARD_ERROR_OF_MEAN|7.23||0.003|TWO_SIDED|95.0|-41.86|-13.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.35|-41.86|0.003
91623781|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.37|STANDARD_ERROR_OF_MEAN|6.49||1|TWO_SIDED|95.0|-16.16|9.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.43|-16.16|1.00
91623782|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.13|STANDARD_ERROR_OF_MEAN|7.18||0.053|TWO_SIDED|95.0|-32.28|-3.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.99|-32.28|0.053
91722485|NCT03881371|183337727|SUPERIORITY||Least-Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8901|TWO_SIDED|95.0|-0.44|0.382||ANCOVA with treatment and centre as independent factors, baseline NRS measurement as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||0.382|-0.440|0.8901
91623783|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.72|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.34|-6.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.10|-27.34|0.073
91623784|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.31|STANDARD_ERROR_OF_MEAN|6.39||0.027|TWO_SIDED|95.0|-21.92|3.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||3.29|-21.92|0.027
91623785|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.67|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-13.05|7.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.72|-13.05|1.00
91623786|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|2.02|STANDARD_ERROR_OF_MEAN|6.43||0.63|TWO_SIDED|95.0|-10.66|14.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.69|-10.66|0.63
91623787|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.03|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-32.03|-4.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.04|-32.03|<0.001
91623788|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.83|STANDARD_ERROR_OF_MEAN|6.52||0.007|TWO_SIDED|95.0|-32.71|-6.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.96|-32.71|0.007
91623789|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.55|STANDARD_ERROR_OF_MEAN|5.71||0.002|TWO_SIDED|95.0|-27.84|-5.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.26|-27.84|0.002
91623790|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.51|STANDARD_ERROR_OF_MEAN|5.33|<|0.001|TWO_SIDED|95.0|-31.04|-9.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.98|-31.04|<0.001
91623791|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.78|STANDARD_ERROR_OF_MEAN|5.62|<|0.001|TWO_SIDED|95.0|-32.88|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.68|-32.88|<0.001
91623792|NCT01763866|183139974|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.36|STANDARD_ERROR_OF_MEAN|6.45|<|0.001|TWO_SIDED|95.0|-44.1|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.62|-44.10|<0.001
91623793|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.36|STANDARD_ERROR_OF_MEAN|4.38||0.088|TWO_SIDED|95.0|-21.99|-4.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.74|-21.99|0.088
91623794|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.31|STANDARD_ERROR_OF_MEAN|5.41||0.005|TWO_SIDED|95.0|-31.98|-10.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.64|-31.98|0.005
91623795|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.45||1|TWO_SIDED|95.0|-10.27|7.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.27|-10.27|1.00
91623796|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.54|STANDARD_ERROR_OF_MEAN|5.39||0.056|TWO_SIDED|95.0|-24.17|-2.91||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.91|-24.17|0.056
91623797|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.21|STANDARD_ERROR_OF_MEAN|4.91||0.073|TWO_SIDED|95.0|-24.88|-5.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.54|-24.88|0.073
91623798|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.69|STANDARD_ERROR_OF_MEAN|5.21||0.027|TWO_SIDED|95.0|-24.97|-4.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.42|-24.97|0.027
91722486|NCT03881371|183337728|SUPERIORITY||Least-Square Mean|0.89|STANDARD_ERROR_OF_MEAN|0.315||0.0049|TWO_SIDED|95.0|0.274|1.515||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||1.515|0.274|0.0049
91481321|NCT00403403|182835738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.3269||95.0|-9.6|29.0|||Chi-squared|||||29.0|-9.6|0.3269
91481322|NCT00403403|182835740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.305||||0.0011|TWO_SIDED|95.0|0.144|0.644|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.644|0.144|0.0011
91623799|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|4.82||1|TWO_SIDED|95.0|-9.94|9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.05|-9.94|1.00
91623800|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.25|STANDARD_ERROR_OF_MEAN|5.28||0.62|TWO_SIDED|95.0|-10.66|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.16|-10.66|0.62
91623801|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.07|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-34.64|-15.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-15.50|-34.64|<0.001
91623802|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.79|STANDARD_ERROR_OF_MEAN|5.58||0.007|TWO_SIDED|95.0|-30.81|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.77|-30.81|0.007
91623803|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.15|STANDARD_ERROR_OF_MEAN|4.61||0.005|TWO_SIDED|95.0|-25.27|-7.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-7.03|-25.27|0.005
91623804|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.18|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-32.11|-14.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.25|-32.11|<0.001
91623805|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.21|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-33.0|-13.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.43|-33.00|<0.001
91623806|NCT01763866|183139975|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.87|STANDARD_ERROR_OF_MEAN|5.43|<|0.001|TWO_SIDED|95.0|-43.6|-22.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-22.14|-43.60|<0.001
91623807|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.47|STANDARD_ERROR_OF_MEAN|4.92||0.088|TWO_SIDED|95.0|-24.16|-4.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.78|-24.16|0.088
91623808|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.47|STANDARD_ERROR_OF_MEAN|7.22||0.005|TWO_SIDED|95.0|-40.71|-12.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.24|-40.71|0.005
91623809|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.54|STANDARD_ERROR_OF_MEAN|5.0||1|TWO_SIDED|95.0|-11.41|8.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.32|-11.41|1.00
91623810|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.19|STANDARD_ERROR_OF_MEAN|7.21||0.056|TWO_SIDED|95.0|-29.4|-0.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-0.97|-29.40|0.056
91623811|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.42|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.05|-5.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.80|-27.05|0.073
91713765|NCT03804268|183319104|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.66||0.0114|TWO_SIDED|95.0|1.3|3.9||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||3.9|1.3|0.0114
91481323|NCT01885871|182835768|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91527726|NCT01976364|182930501|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
91525090|NCT03324880|182925472|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.203|=|0.004|TWO_SIDED|95.0|-0.96|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD anxiety item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD anxiety item score.|-0.15|-0.96|=0.004
91623812|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.6|STANDARD_ERROR_OF_MEAN|6.13||0.027|TWO_SIDED|95.0|-21.68|2.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||2.48|-21.68|0.027
91623813|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.78|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-12.16|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.61|-12.16|1.00
91623814|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.94|STANDARD_ERROR_OF_MEAN|6.18||0.62|TWO_SIDED|95.0|-7.25|17.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||17.14|-7.25|0.62
91623815|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.98|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-34.24|-9.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.73|-34.24|<0.001
91623816|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.75|STANDARD_ERROR_OF_MEAN|6.5||0.007|TWO_SIDED|95.0|-31.6|-5.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.90|-31.60|0.007
91623817|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.19|STANDARD_ERROR_OF_MEAN|5.7||0.005|TWO_SIDED|95.0|-27.46|-4.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.92|-27.46|0.005
91623818|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.54|STANDARD_ERROR_OF_MEAN|5.31|<|0.001|TWO_SIDED|95.0|-29.04|-8.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.05|-29.04|<0.001
91623819|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.45|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-33.09|-11.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.81|-33.09|<0.001
91623820|NCT01763866|183139976|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.83|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-48.96|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-24.70|-48.96|<0.001
91623821|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.53|STANDARD_ERROR_OF_MEAN|1.84||0.034|TWO_SIDED|95.0|2.91|10.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.15|2.91|0.034
91623822|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.11|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|3.43|12.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.79|3.43|0.017
91623823|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.67|STANDARD_ERROR_OF_MEAN|1.86||0.001|TWO_SIDED|95.0|3.0|10.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.34|3.00|0.001
91691908|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6233|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6233
91623824|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.57|STANDARD_ERROR_OF_MEAN|2.36||0.006|TWO_SIDED|95.0|3.93|13.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.22|3.93|0.006
91623825|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.95|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-0.19|8.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.09|-0.19|0.85
91661737|NCT01299454|183218337|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.241|||||TWO_SIDED|90.0|0.719|2.143|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.143|0.719|
91661738|NCT01299454|183218337|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance|Geometric Mean Ratio|1.604|||||TWO_SIDED|90.0|0.942|2.732|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.732|0.942|
91661739|NCT01299454|183218337|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.077|||||TWO_SIDED|90.0|0.54|2.146|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.146|0.540|
91661740|NCT01299454|183218338|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.691|1.059|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.059|0.691|
91661741|NCT01299454|183218338|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.742|||||TWO_SIDED|90.0|0.599|0.918|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.918|0.599|
91661742|NCT01299454|183218338|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.451|||||TWO_SIDED|90.0|0.352|0.577|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.577|0.352|
91481324|NCT05454657|182835799|SUPERIORITY||Slope|-0.01|||<|0.05|TWO_SIDED|95.0|-0.015|-0.008|||Mixed Models Analysis||Cross-level interaction effect of Study Day X Treatment Group|To test the effect of HRVB vs control on negative affect, a multilevel model was estimated where study day predicted mean negative affect that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of negative affect. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily negative affect.||-.008|-.015|<.05
91489384|NCT02484690|182851570|SUPERIORITY||Difference in Percentage of Participants|-5.71||||0.2328|TWO_SIDED|80.0|-10.74|-0.69||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||-0.69|-10.74|0.2328
91527727|NCT01976364|182930502|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
91623826|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|4.68|13.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.58|4.68|<0.001
91623827|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.57|STANDARD_ERROR_OF_MEAN|2.06||0.003|TWO_SIDED|95.0|3.51|11.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.64|3.51|0.003
91623828|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.35|STANDARD_ERROR_OF_MEAN|2.28||0.003|TWO_SIDED|95.0|3.86|12.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.84|3.86|0.003
91623829|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.36|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|1.68|9.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.04|1.68|<0.001
91623830|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.66|STANDARD_ERROR_OF_MEAN|3.11||0.01|TWO_SIDED|95.0|2.51|14.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.80|2.51|0.010
91623831|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.46|STANDARD_ERROR_OF_MEAN|1.91||0.013|TWO_SIDED|95.0|1.69|9.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.23|1.69|0.013
91661743|NCT01299454|183218347|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.509|||||TWO_SIDED|90.0|0.346|0.748|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.748|0.346|
91661744|NCT01299454|183218347|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.586|||||TWO_SIDED|90.0|0.399|0.861|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.861|0.399|
91661745|NCT01299454|183218347|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.334|||||TWO_SIDED|90.0|0.214|0.521|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.521|0.214|
91713766|NCT03804268|183319105|SUPERIORITY||Percentage Difference|12.6||||0.0171|TWO_SIDED|95.0|3.5|21.6||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||21.6|3.5|0.0171
91481325|NCT05454657|182835800|SUPERIORITY||Slope|0.01|||<|0.05|TWO_SIDED|95.0|-0.677|0.857|||Mixed Models Analysis||Cross-level interaction effect of Study Day X Treatment Group|To test the effect of HRVB vs. control on positive affect, a multilevel model was estimated where study day predicted mean positive affect that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of positive affect. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily positive affect.||.857|-.677|<.05
91623832|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.75|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|2.4|11.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.10|2.40|0.002
91623833|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|10.23|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|5.13|15.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.32|5.13|<0.001
91481326|NCT05454657|182835801|SUPERIORITY||Slope|-0.02|||<|0.05|TWO_SIDED|95.0|-0.026|-0.014|||Mixed Models Analysis||Cross-level interaction effect of Study Day X Treatment Group|To test the effect of HRVB vs. control on craving, a multilevel model was estimated where study day predicted mean craving that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of craving. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily craving.||-.014|-.026|<.05
91481327|NCT05454657|182835802|SUPERIORITY||Odds Ratio (OR)|0.36|||<|0.05|TWO_SIDED|95.0|0.245|0.543||95% Bayesian Credible Intervals Intervals are used to determine significance, and significance is represented by credible intervals that do not include 0 or 1.00 when odds ratios are calculated.|Mixed Models Analysis||Main effect of treatment group|To test the effect of HRVB vs. control on AOD use A Bayesian logistic multilevel model was estimated where study day predicted AOD use that same day (L1; within-person), while controlling for day-of-the-week. At Level 2 (between-person), treatment condition and sex were included as predictors of AOD use. The focal effects were the main effect of treatment condition (L2) and cross-level interactions between study day (L1) and treatment condition (L2) predicting daily AOD use.||0.543|0.245|<0.05
91481328|NCT05454657|182835803|EQUIVALENCE|Two-sample t test with unequal variances|Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|3.33||0.66|TWO_SIDED|95.0|-8.07|5.13|||t-test, 2 sided|Unequal variances were specified as part of the model.||Two-sample t test with unequal variances||5.13|-8.07|.660
91481329|NCT01041495|182835809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.869||||0.869|TWO_SIDED|95.0||||P values below 0.05 were considered statistically significant|t-test, 2 sided|||||||.869
91481330|NCT01041495|182835810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.486|TWO_SIDED||||||t-test, 2 sided|||Visual Analogue Pain Scale (VAPS). The final visit VAPS at 8th week will be compared against baseline VAPS scores for both treatment groups||||.486
91481331|NCT01041495|182835810|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||t-test, 1 sided|||||||.486
91481332|NCT01041495|182835811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.0||||0.869|TWO_SIDED||||||t-test, 2 sided||As above- this was the difference between the groups on mean avg, it was used here|||||.869
91481333|NCT01041495|182835811|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.275|TWO_SIDED||||||t-test, 1 sided|||||||.275
91481334|NCT03584373|182835812|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.14||||0.7|TWO_SIDED|95.0|-0.89|0.6|||t-test, 2 sided|||||0.60|-0.89|0.70
91481335|NCT03584373|182835813|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.23||||0.58|TWO_SIDED|95.0|-1.08|0.61|||t-test, 2 sided|||||0.61|-1.08|0.58
91481336|NCT03584373|182835814|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.91||||0.006|TWO_SIDED|95.0|-3.25|-0.56|||t-test, 2 sided|||||-0.56|-3.25|0.006
91623834|NCT01763866|183139977|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.85|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|4.73|12.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||12.97|4.73|<0.001
91623835|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.83|STANDARD_ERROR_OF_MEAN|2.11||0.034|TWO_SIDED|95.0|2.66|10.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.99|2.66|0.034
91623836|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|2.46||0.017|TWO_SIDED|95.0|3.01|12.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.73|3.01|0.017
91713767|NCT03804268|183319106|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.0114|TWO_SIDED|95.0|0.5|1.1||ANCOVA was used with study intervention group, age group, baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.5|0.0114
91713768|NCT03804268|183319107|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09||0.0114|TWO_SIDED|95.0|-0.6|-0.3||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.3|-0.6|0.0114
91481337|NCT03584373|182835815|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.16||||0.04|TWO_SIDED|95.0|-2.26|-0.06|||t-test, 2 sided|||||-0.06|-2.26|0.04
91481338|NCT03584373|182835816|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.55||||0.33|TWO_SIDED|95.0|-1.67|0.56|||t-test, 2 sided|||||0.56|-1.67|0.33
91481339|NCT03584373|182835817|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|0.06||||0.47|TWO_SIDED|95.0|-0.1|0.21|||t-test, 2 sided|||||0.21|-0.10|0.47
91481340|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.6|-2.5|
91481341|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-9.6|||||TWO_SIDED|95.0|-16.0|-3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-3.3|-16.0|
91481342|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|2.2|||||TWO_SIDED|95.0|-0.4|5.2||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.2|-0.4|
91481343|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.5|||||TWO_SIDED|95.0|-0.9|4.1||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.1|-0.9|
91661746|NCT01299454|183218348|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.445|1.153|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.153|0.445|
91623837|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.81|STANDARD_ERROR_OF_MEAN|2.14||0.001|TWO_SIDED|95.0|4.58|13.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.03|4.58|0.001
91623838|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.28|STANDARD_ERROR_OF_MEAN|2.45||0.006|TWO_SIDED|95.0|3.46|13.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.11|3.46|0.006
91623839|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.07|STANDARD_ERROR_OF_MEAN|2.28||0.85|TWO_SIDED|95.0|-0.42|8.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.57|-0.42|0.85
91623840|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.05|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|2.22|11.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.89|2.22|<0.001
91623841|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.47|STANDARD_ERROR_OF_MEAN|2.23||0.003|TWO_SIDED|95.0|4.07|12.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.87|4.07|0.003
91623842|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.14|STANDARD_ERROR_OF_MEAN|2.46||0.003|TWO_SIDED|95.0|2.29|11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.99|2.29|0.003
91661747|NCT01299454|183218348|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.594|||||TWO_SIDED|90.0|0.378|0.934|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.934|0.378|
91661748|NCT01299454|183218348|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.561|||||TWO_SIDED|90.0|0.308|1.022|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.022|0.308|
91623843|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-1.33|7.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.73|-1.33|<0.001
91623844|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.35|STANDARD_ERROR_OF_MEAN|3.23||0.01|TWO_SIDED|95.0|0.97|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.72|0.97|0.010
91623845|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.04|STANDARD_ERROR_OF_MEAN|2.29||0.013|TWO_SIDED|95.0|0.52|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.56|0.52|0.013
91623846|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.84|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|0.07|9.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.60|0.07|0.002
91623847|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.78|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.05|15.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.51|4.05|<0.001
91481344|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.4|||||TWO_SIDED|95.0|-4.2|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.2|
91481345|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.3|||||TWO_SIDED|95.0|-3.8|3.3||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-3.8|
91623848|NCT01763866|183139978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.06|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|4.4|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||13.72|4.40|<0.001
91623849|NCT01669811|183140003|SUPERIORITY_OR_OTHER||Difference in proportions|23.8|||<|0.0001|TWO_SIDED|95.0|14.9|32.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||32.6|14.9|<0.0001
91623850|NCT01669811|183140004|SUPERIORITY_OR_OTHER||Difference in proportions|32.8|||<|0.0001|TWO_SIDED|95.0|21.9|42.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||42.6|21.9|<0.0001
91623851|NCT01669811|183140005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.1452|TWO_SIDED|95.0|0.91|1.83|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||1.83|0.91|0.1452
91623852|NCT01669811|183140006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.0837|TWO_SIDED|95.0|0.97|2.18|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.18|0.97|0.0837
91623853|NCT01669811|183140007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.2678|TWO_SIDED|95.0|0.8|2.26|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.26|0.80|0.2678
91623854|NCT01669811|183140008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6389|TWO_SIDED|95.0|0.62|2.12|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.12|0.62|0.6389
91623855|NCT01669811|183140009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.38||||0.4485|TWO_SIDED|95.0|0.8|2.38|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.38|0.80|0.4485
91623856|NCT00093470|183140046|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.026|TWO_SIDED|95.0|0.538|1.072||one-sided p-value; threshold for statistical significance \<0.025|Log Rank|stratified log rank test|Hazard ratio of DFS for Arm A to Arm B|||1.072|0.538|0.026
91623857|NCT00093470|183140047|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.809||||0.056|TWO_SIDED|95.0|0.567|1.155||one-sided p-value; threshold for statistical significance \< 0.025|Log Rank|stratified log rank test|Hazard ratio of OS for Arm A to Arm B|||1.155|0.567|0.056
91623858|NCT01019252|183140050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24|||<|0.0001|TWO_SIDED|95.0|3.28|7.21|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||7.21|3.28|<.0001
91623859|NCT01019252|183140051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.94|1.39|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||1.39|.94|<.0001
91623860|NCT01019252|183140052|SUPERIORITY||Mean Difference (Net)|10.93|||<|0.0001|TWO_SIDED|95.0|8.93|12.93|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||12.93|8.93|<.0001
91623861|NCT02514772|183140053|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
91623862|NCT02514772|183140054|OTHER||Difference (%)|-1.7|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
91623863|NCT02514772|183140055|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-21.2|17.6||||||||17.6|-21.2|
91623864|NCT02514772|183140056|OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-24.2|13.3||||||Incidence difference of infusion-related reactions, occurred on day of or on day after first infusion (i.e. on study day 1 or on study day 2).||13.3|-24.2|
91623865|NCT02514772|183140056|OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-24.5|13.6||||||Incidence difference of infusion-related reactions, occurred on day of or on day after second infusion (i.e. on study day 14 or on study day 15).||13.6|-24.5|
91623866|NCT02514772|183140056|OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-26.0|11.4||||||Incidence difference of infusion-related reactions overall on day(s) of or day(s) after either infusion (i.e. on day 1 or 2 and on day 14 or day 15).||11.4|-26.0|
91661749|NCT01299454|183218349|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.558|||||TWO_SIDED|90.0|0.368|0.845|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.845|0.368|
91713769|NCT03804268|183319108|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0114|TWO_SIDED|95.0|-0.4|-0.1||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.1|-0.4|0.0114
91713770|NCT02849587|183319109|SUPERIORITY||||||<|0.001|||||||Generalized least squares model|||||||<0.001
91713771|NCT02849587|183319110|SUPERIORITY|||||||0.022|||||||Generalized least squares model|Raw data converted to z-score based on pre-smoking performance of entire sample.||||||0.022
91713772|NCT02849587|183319111|SUPERIORITY|||||||0.283|||||||Generalized least squares model|||||||0.283
91481346|NCT00366340|182835829|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-6.0|4.5||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.5|-6.0|
91481347|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.84|0.63|
91623867|NCT00877006|183140067|SUPERIORITY_OR_OTHER|||||||0.0005||||||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.|ANCOVA|||The hypothesis of interest is superiority of BR over standard treatment.||||0.0005
91623868|NCT00877006|183140068|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9677|TWO_SIDED|95.0|0.58|1.68|||Log Rank|Stratified log-rank test by preassigned standard treatment and lymphoma type.|BR/RCHOP-RCVP|||1.68|0.58|0.9677
91623869|NCT03657810|183140141|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator.|Regression, Logistic|||||||<0.001
91623870|NCT03657810|183140142|SUPERIORITY|||||||0.052|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator|Regression, Logistic|||||||0.052
91623871|NCT01632735|183140155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.57|0.99|||GEE|Generalized Estimating Equations regression examined primary relapse (measured by urinalysis) over time by condition, controlling for age and gender.||||0.99|0.57|<0.05
91623872|NCT01632735|183140156|SUPERIORITY_OR_OTHER||Beta (timexcondition)|0.239|||<|0.001|TWO_SIDED|95.0|0.219|0.248|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the primary outcome measures of recovery behaviors mean days over time (baseline, discharge, 3, 6, and 9-month follow-ups).||0.248|0.219|<0.001
91623873|NCT01632735|183140157|SUPERIORITY_OR_OTHER||Beta (time x condition)|0.115|||<|0.001|TWO_SIDED|95.0|0.106|0.123|||Mixed Models Analysis|A repeated-measures model tested for effects of treatment vs. control on recovery self-confidence over time controlling for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of recovery confidence mean score over time.||0.123|0.106|<0.001
91623874|NCT01632735|183140158|SUPERIORITY_OR_OTHER||Beta effect (timexcondition)|0.217|||<|0.001|TWO_SIDED|95.0|0.2|0.233|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of self-help utilization (mean days in past month) over the study period (baseline, discharge, and 3-, 6-, and 9-month follow-ups).||0.233|0.2|<0.001
91623875|NCT03589885|183140198|SUPERIORITY||Odds Ratio (OR)|1014.07|||<|0.0001|TWO_SIDED|95.0|68.83|14940.62|||Regression, Logistic|||PASI 75||14940.62|68.83|<0.0001
91623876|NCT03589885|183140198|SUPERIORITY||Odds Ratio (OR)|96.23|||<|0.0001|TWO_SIDED|95.0|17.22|537.78|||Regression, Logistic|||PASI 75||537.78|17.22|<0.0001
91623877|NCT03589885|183140199|SUPERIORITY||Odds Ratio (OR)|51.46|||<|0.0001|TWO_SIDED|95.0|11.95|221.64|||Regression, Logistic|||||221.64|11.95|<0.0001
91623878|NCT03589885|183140199|SUPERIORITY||Odds Ratio (OR)|29.7|||<|0.0001||95.0|7.38|119.57|||Regression, Logistic|||||119.57|7.38|<0.0001
91623879|NCT03589885|183140200|SUPERIORITY||Odds Ratio (OR)|88.46|||<|0.0001|TWO_SIDED|95.0|16.15|484.52|||Regression, Logistic|||||484.52|16.15|<0.0001
91623880|NCT03589885|183140200|SUPERIORITY||Odds Ratio (OR)|37.9|||<|0.0001|TWO_SIDED|95.0|7.6|189.01|||Regression, Logistic|||||189.01|7.60|<0.0001
91623881|NCT04111107|183140204|OTHER|||||||0.966|||||||Wilcoxon signed rank (2 sided)|||H0: Progression-free ratio = 1||||0.966
91623882|NCT04111107|183140207|OTHER|Single proportion was estimated.|proportion|4.2|||||TWO_SIDED|95.0|0.1|21.1|||||exact binomial confidence interval|The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated||21.1|0.1|
91623883|NCT00039741|183140230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.26|TWO_SIDED|95.0|-0.41|0.11|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.11|-0.41|0.26
91623884|NCT00039741|183140230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED|95.0|-0.2|0.32|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.32|-0.20|0.56
91623885|NCT00321269|183140259|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\>F=0.90.||||0.90
91623886|NCT00321269|183140260|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|F(2,110)=2.08; P=0.13||||||0.13
91623887|NCT03571256|183140270|OTHER||LS mean difference|-0.8||||0.6|TWO_SIDED|95.0|-3.9|2.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.3|-3.9|0.600
91623888|NCT01948141|183140294|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||||||0.59
91623889|NCT01948141|183140297|SUPERIORITY_OR_OTHER|||||||0.36|||||||Log Rank|||||||0.36
91623890|NCT01861054|183140333|OTHER|||||||0.3149||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Comparison on ALDH+ cells by ALDEFLUOR assay||||0.3149
91623891|NCT01861054|183140333|OTHER|||||||0.8148||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Comparison on CD44+/CD24- by flow citometry||||0.8148
91481348|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.82|0.52|
91481349|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.74|
91481350|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.76|
91525091|NCT03324880|182925473|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.2|=|0.004|TWO_SIDED|95.0|-0.93|-0.14||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD sadness or depression item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD sadness or depression item score.|-0.14|-0.93|=0.004
91623892|NCT01861054|183140334|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho AKT Extent||||>0.9999
91623893|NCT01861054|183140334|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-AKT Intensity||||>0.9999
91623894|NCT01861054|183140334|OTHER|||||||0.2245|||||||Wilcoxon (Mann-Whitney)|||AKT Extent||||0.2245
91623895|NCT01861054|183140334|OTHER|||||||0.5785|||||||Wilcoxon (Mann-Whitney)|||AKT Intensity||||0.5785
91623896|NCT01861054|183140334|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Extent||||>0.9999
91623897|NCT01861054|183140334|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Intensity||||0.3139
91623898|NCT01861054|183140334|OTHER|||||||0.212|||||||Wilcoxon (Mann-Whitney)|||FAK Extent||||0.2120
91623899|NCT01861054|183140334|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||FAK Intensity||||>0.9999
91623900|NCT01861054|183140334|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Extent||||>0.9999
91623901|NCT01861054|183140334|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Intensity||||0.8728
91623902|NCT01861054|183140334|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Extent||||>0.9999
91623903|NCT01861054|183140334|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Intensity||||0.8728
91623904|NCT01861054|183140334|OTHER|||||||0.2265|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Extent||||0.2265
91623905|NCT01861054|183140334|OTHER|||||||0.2403|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Intensity||||0.2403
91623906|NCT01861054|183140335|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 1 Beta||||>0.9999
91623907|NCT01861054|183140335|OTHER|||||||0.6945||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 6||||0.6945
91623908|NCT01861054|183140335|OTHER|||||||0.9448||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Interleukin 8||||0.9448
91623909|NCT01861054|183140335|OTHER|||||||0.6292||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Tumor Necrosis Factor - alpha||||0.6292
91623910|NCT01861054|183140335|OTHER|||||||0.2354||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Granulocyte Macrophage Colony Stm Factor||||0.2354
91661750|NCT01299454|183218349|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.516|||||TWO_SIDED|90.0|0.341|0.781|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.781|0.341|
91713773|NCT02849587|183319112|SUPERIORITY|||||||0.0503|||||||Generalized estimating equations model|||||||0.0503
91623911|NCT01861054|183140335|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Vascular Endothelial Growth Factor||||>0.9999
91623912|NCT01861054|183140335|OTHER|||||||0.4719||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Basic Fibroblast Growth Factor||||0.4719
91623913|NCT01861054|183140336|OTHER|||||||0.0951|||||||Wilcoxon (Mann-Whitney)|||CD31 Extent||||0.0951
91623914|NCT01861054|183140336|OTHER|||||||0.1643|||||||Wilcoxon (Mann-Whitney)|||CD31 Intensity||||0.1643
91623915|NCT01861054|183140337|OTHER|||||||0.4183|||||||Wilcoxon (Mann-Whitney)|||P62 Extent||||0.4183
91623916|NCT01861054|183140337|OTHER|||||||0.3702|||||||Wilcoxon (Mann-Whitney)|||P62 Intensity||||0.3702
91623917|NCT01861054|183140342|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Lymphocyte in WBC||||0.6168
91623918|NCT01861054|183140342|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Total T cell in lymphocytes||||0.6168
91623919|NCT01861054|183140342|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||B cell in lymphocytes||||0.1453
91623920|NCT01861054|183140342|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||T-helper cell in lymphocytes||||0.1453
91623921|NCT01861054|183140342|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CTL in lymphocytes||||0.1453
91623922|NCT01861054|183140342|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||NKT cell in lymphocytes||||>0.9999
91623923|NCT01861054|183140342|OTHER|||||||0.7634||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||ADCC NK subsets in lymphocytes||||0.7634
91481351|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|2.25|||||TWO_SIDED|95.0|2.04|2.49||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||2.49|2.04|
91481352|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.71|0.51|
91481353|NCT00366340|182835830|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.06|0.73|
91481354|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.6|||||TWO_SIDED|95.0|-3.0|8.3||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||8.3|-3.0|
91481355|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.5|||||TWO_SIDED|95.0|-4.1|13.0||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||13.0|-4.1|
91623924|NCT01861054|183140342|OTHER|||||||0.5487||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Regulatory NK subsets in lymphocytes||||0.5487
91623925|NCT01861054|183140342|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Exhausted NK subsets in lymphocytes||||>0.9999
91661751|NCT01299454|183218349|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.314|||||TWO_SIDED|90.0|0.195|0.507|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.507|0.195|
91661752|NCT03437265|183218368|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
91481356|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.5||||||For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.4|
91481357|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-9.3|0.3||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||0.3|-9.3|
91481358|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||1.5|-1.5|
91661753|NCT03437265|183218369|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
91661754|NCT03437265|183218370|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
91661755|NCT03437265|183218371|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
91481359|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.0|2.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||2.3|-5.0|
91481360|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.7|||||TWO_SIDED|95.0|-0.4|4.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||4.4|-0.4|
91623926|NCT01861054|183140342|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD56-CD16+ NK subsets in lymphocytes||||>0.9999
91623927|NCT01861054|183140342|OTHER|||||||0.1451||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - IL-8||||0.1451
91661756|NCT03437265|183218372|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
91623928|NCT01861054|183140342|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - IL-8||||0.2779
91623929|NCT01861054|183140342|OTHER|||||||0.1444||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - IL-8||||0.1444
91623930|NCT01861054|183140342|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - IL-8||||0.1453
91623931|NCT01861054|183140342|OTHER|||||||0.92||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - IL-8||||0.9200
91623932|NCT01861054|183140342|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - US||||0.2779
91623933|NCT01861054|183140342|OTHER|||||||0.6164||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - US||||0.6164
91623934|NCT01861054|183140342|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - US||||>0.9999
91623935|NCT01861054|183140342|OTHER|||||||0.2032||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - US||||0.2032
91623936|NCT01861054|183140342|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - US||||>0.9999
91623937|NCT01861054|183140342|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - IL-8||||0.5250
91623938|NCT01861054|183140342|OTHER|||||||0.6706||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - IL-8||||0.6706
91623939|NCT01861054|183140342|OTHER|||||||0.8312||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - IL-8||||0.8312
91623940|NCT01861054|183140342|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - IL-8||||0.3992
91623941|NCT01861054|183140342|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - IL-8||||0.2952
91623942|NCT01861054|183140342|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - IL-8||||0.3992
91623943|NCT01861054|183140342|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - IL-8||||0.2952
91623944|NCT01861054|183140342|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - IL-8||||0.5250
91623945|NCT01861054|183140342|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - US||||0.3992
91623946|NCT01861054|183140342|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - US||||0.2952
91661757|NCT03437265|183218373|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented. The Geometric CV for glycolic acid was Not Calculated (appears as 0%).|||
91661758|NCT03437265|183218374|OTHER||||||||||||||||||Summary of the number of bowel movements per time period for the PD analysis set|||
91623947|NCT01861054|183140342|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - US||||>0.9999
91661759|NCT03437265|183218375|OTHER||||||||||||||||||The time (in minutes) to achieve clear effluent/time to turbid contents is presented for the PD analysis set.|||
91661760|NCT01667679|183218397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|0.824|<|0.0001|TWO_SIDED|95.0|1.76|5.01|||ANCOVA|||||5.01|1.76|<0.0001
91713774|NCT02849587|183319113|SUPERIORITY|||||||0.024|||||||Generalized least squares model|||||||0.024
91623948|NCT01861054|183140342|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - US||||0.3992
91623949|NCT01861054|183140342|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - US||||0.3992
91623950|NCT01861054|183140342|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - US||||0.2952
91623951|NCT01861054|183140342|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - US||||0.3992
91623952|NCT01861054|183140342|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - US||||0.2952
91623953|NCT01861054|183140342|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS||||0.2238
91623954|NCT01861054|183140342|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS||||0.2238
91623955|NCT01861054|183140342|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS||||0.1543
91661761|NCT01667679|183218398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.105||0.0013|TWO_SIDED|95.0|1.47|5.85|||ANCOVA||mild attacks|||5.85|1.47|0.0013
91661762|NCT01667679|183218398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76|STANDARD_ERROR_OF_MEAN|0.971||0.0002|TWO_SIDED|95.0|1.84|5.68|||ANCOVA||moderate/severe attacks|||5.68|1.84|0.0002
91661763|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3549|TWO_SIDED|95.0|0.85|1.6|||ANCOVA||10 minutes post-dose|||1.60|0.85|0.3549
91661764|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0005|TWO_SIDED|95.0|1.2|1.9|||ANCOVA||15 minutes post-dose|||1.90|1.20|0.0005
91661765|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.45|2.21|||ANCOVA||30 minutes post-dose|||2.21|1.45|<0.0001
91661766|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.0002|TWO_SIDED|95.0|1.24|1.96|||ANCOVA||45 minutes post-dose|||1.96|1.24|0.0002
91661767|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0057|TWO_SIDED|95.0|1.1|1.71|||ANCOVA||60 minutes post-dose|||1.71|1.10|0.0057
91661768|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.0654|TWO_SIDED|95.0|0.99|1.61|||ANCOVA||90 minutes post-dose|||1.61|0.99|0.0654
91661769|NCT01667679|183218399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2894|TWO_SIDED|95.0|0.89|1.49|||ANCOVA||120 minutes post-dose|||1.49|0.89|0.2894
91661770|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.1771|TWO_SIDED|95.0|0.76|4.54|||ANCOVA||10 minutes post-dose|||4.54|0.76|0.1771
91661771|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0077|TWO_SIDED|95.0|1.21|3.42|||ANCOVA||15 minutes post-dose|||3.42|1.21|0.0077
91661772|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0003|TWO_SIDED|95.0|1.32|2.5|||ANCOVA||30 minutes post-dose|||2.50|1.32|0.0003
91661773|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.29|2.09|||ANCOVA||45 minutes post-dose|||2.09|1.29|<0.0001
91661774|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0016|TWO_SIDED|95.0|1.14|1.74|||ANCOVA||60 minutes post-dose|||1.74|1.14|0.0016
91661775|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0059|TWO_SIDED|95.0|1.09|1.69|||ANCOVA||90 minutes post-dose|||1.69|1.09|0.0059
91661776|NCT01667679|183218400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.2717|TWO_SIDED|95.0|0.91|1.42|||ANCOVA||120 minutes post-dose|||1.42|0.91|0.2717
91661777|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.2426|TWO_SIDED|95.0|0.87|1.77|||ANCOVA||10 minutes post-dose|||1.77|0.87|0.2426
91661778|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0069|TWO_SIDED|95.0|1.12|1.99|||ANCOVA||15 minutes post-dose|||1.99|1.12|0.0069
91661779|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94|||<|0.0001|TWO_SIDED|95.0|1.47|2.56|||ANCOVA||30 minutes post-dose|||2.56|1.47|<0.0001
91661780|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0004|TWO_SIDED|95.0|1.26|2.23|||ANCOVA||45 minutes post-dose|||2.23|1.26|0.0004
91661781|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0008|TWO_SIDED|95.0|1.22|2.11|||ANCOVA||60 minutes post-dose|||2.11|1.22|0.0008
91661782|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0272|TWO_SIDED|95.0|1.04|1.83|||ANCOVA||90 minutes post-dose|||1.83|1.04|0.0272
91661783|NCT01667679|183218401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2085|TWO_SIDED|95.0|0.9|1.62|||ANCOVA||120 minutes post-dose|||1.62|0.90|0.2085
91661784|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.021||0.3562|TWO_SIDED|95.0|-0.06|0.02|||ANCOVA||10 minutes post-dose|||0.02|-0.06|0.3562
91661785|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.029||0.0063|TWO_SIDED|94.0|-0.14|-0.02|||ANCOVA||15 minutes post-dose|||-0.02|-0.14|0.0063
91661786|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA||30 minutes post-dose|||-0.11|-0.26|< 0.0001
91661787|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0005|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||45 minutes post-dose|||-0.07|-0.26|0.0005
91661788|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.048||0.004|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA||60 minutes post-dose|||-0.05|-0.24|0.0040
91661789|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0333|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA||90 minutes post-dose|||-0.01|-0.21|0.0333
91661790|NCT01667679|183218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.052||0.4031|TWO_SIDED|95.0|-0.15|0.06|||ANCOVA||120 minutes post-dose|||0.06|-0.15|0.4031
91661791|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||0.0181|TWO_SIDED|95.0|-0.08|-0.01|||ANCOVA||10 minutes post-dose|||-0.01|-0.08|0.0181
91661792|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||15 minutes post-dose|||-0.04|-0.14|0.0003
91661793|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.23|-0.09|||ANCOVA||30 minutes post-dose|||-0.09|-0.23|< 0.0001
91661794|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|-0.25|-0.08|||ANCOVA||45 minutes post-dose|||-0.08|-0.25|0.0001
91661795|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.0006|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||60 minutes post-dose|||-0.07|-0.26|0.0006
91661796|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.048||0.0189|TWO_SIDED|95.0|-0.21|-0.02|||ANCOVA||90 minutes post-dose|||-0.02|-0.21|0.0189
91713775|NCT02849587|183319114|SUPERIORITY|||||||0.716|||||||Generalized least squares model|The outcome was standardized prior to analyses.||||||0.716
91661797|NCT01667679|183218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.1704|TWO_SIDED|95.0|-0.17|0.03|||ANCOVA||120 minutes post-dose|||0.03|-0.17|0.1704
91713776|NCT02849587|183319115|SUPERIORITY|||||||0.005|||||||Generalized least squares model|The outcome was standardized prior to analysis.||||||0.005
91623956|NCT01861054|183140342|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS||||0.1547
91623957|NCT01861054|183140342|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS||||0.1547
91623958|NCT01861054|183140342|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS||||0.1547
91481361|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.4|-1.4|
91481362|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||1.4|-1.4|
91481363|NCT00366340|182835833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8||||||95.0|-1.3|3.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||3.3|-1.3|
91481364|NCT00366340|182835834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.58|0.96|
91481365|NCT00366340|182835834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39||||||For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated||1.39|0.95|
91481366|NCT00366340|182835835|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
91481367|NCT00366340|182835835|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87|||||TWO_SIDED|95.0|0.75|1.01||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.01|0.75|
91481368|NCT00366340|182835836|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.11||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.||1.11|0.69|
91481369|NCT00366340|182835836|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93|||||TWO_SIDED|95.0|0.71|1.22||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.71|
91481370|NCT02011893|182835888|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.|||||<|0.001|||||||t-distribution|95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||<0.001
91481371|NCT02011893|182835889|SUPERIORITY_OR_OTHER|||||||0.083||||||Superiority analysis performed|McNemar|||||||0.083
91481372|NCT02011893|182835891|SUPERIORITY_OR_OTHER|||||||0.017||||||Superiority analysis performed|t-distribution|95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||0.017
91481373|NCT01255787|182835934|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|1.123||0.907|TWO_SIDED|95.0|-3.258|2.035||Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.|ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.||2.035|-3.258|0.9070
91481374|NCT01255787|182835934|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|1.114||0.3006|TWO_SIDED|95.0|-4.31|0.938|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.938|-4.310|0.3006
91481375|NCT01255787|182835934|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.11||0.2399|TWO_SIDED|95.0|-4.436|0.794|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.794|-4.436|0.2399
91623959|NCT01861054|183140342|OTHER|||||||0.4314||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS||||0.4314
91623960|NCT01861054|183140342|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS||||0.3153
91623961|NCT01861054|183140342|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS+IL-8||||0.4700
91623962|NCT01861054|183140342|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS+IL-8||||0.1605
91623963|NCT01861054|183140342|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS+IL-8||||0.1605
91623964|NCT01861054|183140342|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS+IL-8||||0.1605
91661798|NCT01175018|183218426|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91661799|NCT01175018|183218427|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
91713777|NCT02849587|183319116|SUPERIORITY|||||||0.366|||||||Generalized Estimating Equations model|||||||.366
91713778|NCT02849587|183319117|SUPERIORITY|||||||0.225|||||||Generalized least squares model|Outcome was log10 transformed prior to analyses.||||||.225
91713779|NCT02849587|183319118|SUPERIORITY|||||||0.592|||||||Generalized least squares model|The outcome was transformed using logit function prior to analyses. Model included treatment (3 groups), time (5 times), and their interaction.||||||.592
91713780|NCT02849587|183319119|SUPERIORITY|||||||0.294|||||||Generalized least squares model|||||||.294
91713781|NCT02849587|183319120|SUPERIORITY|||||||0.144|||||||Generalized least squares model|||||||.144
91713782|NCT02849587|183319121|OTHER|Spearman's correlation||||||0.09|||||||Spearman's correlation|||||||0.090
91713783|NCT02849587|183319121|OTHER|Spearman's correlation||||||0.0006|||||||Spearman's correlation|||||||.0006
91527728|NCT01976364|182930502|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
91623965|NCT01861054|183140342|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS+IL-8||||0.1547
91623966|NCT01861054|183140342|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS+IL-8||||0.1547
91623967|NCT01861054|183140342|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS+IL-8||||0.3153
91623968|NCT01861054|183140342|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS+IL-8||||0.1543
91623969|NCT01861054|183140342|OTHER|||||||0.1601||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Control||||0.1601
91623970|NCT01861054|183140342|OTHER|||||||0.2368||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Test||||0.2368
91623971|NCT01861054|183140342|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs unstimulated||||0.1605
91623972|NCT01861054|183140342|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs fMLP||||0.4700
91623973|NCT01861054|183140342|OTHER|||||||0.3392||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin unstimulated||||0.3392
91623974|NCT01861054|183140342|OTHER|||||||0.808||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin fMLP||||0.8080
91623975|NCT00599027|183140343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Endpoint after 28 days of treatment|ANCOVA|Overall treatment effect tested using F-test(alpha=0.05;two-sided). Diff between least square means of the 2 groups calculated with two-sided 95% C.I||||||0.001
91623976|NCT04962503|183140344|OTHER|||||||0.0313||||||Change from baseline to Day 3|Wilcoxon (Mann-Whitney)|||||||0.0313
91623977|NCT04962503|183140344|OTHER|||||||0.0625||||||Change from baseline to Day 9|Wilcoxon (Mann-Whitney)|||||||0.0625
91623978|NCT00476996|183140354|SUPERIORITY||Weighted Difference|20.4|||<|0.0001|TWO_SIDED|95.0|12.8|27.9|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.9|12.8|< 0.0001
91623979|NCT00476996|183140354|SUPERIORITY||Weighted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|17.7|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|17.7|< 0.0001
91623980|NCT00476996|183140354|SUPERIORITY||Weighted Difference|29.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||36.6|21.6|< 0.0001
91623981|NCT00476996|183140354|SUPERIORITY||Weighted Difference|30.3|||<|0.0001|TWO_SIDED|95.0|22.8|37.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||37.7|22.8|< 0.0001
91623982|NCT00476996|183140355|SUPERIORITY||Weighted Difference|2.1||||0.1885|TWO_SIDED|95.0|-1.0|5.2|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||5.2|-1.0|0.1885
91623983|NCT00476996|183140355|SUPERIORITY||Weighted Difference|3.6||||0.033|TWO_SIDED|95.0|0.3|6.8|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||6.8|0.3|0.0330
91623984|NCT00476996|183140356|SUPERIORITY||Weighted Difference|4.2||||0.0175|TWO_SIDED|95.0|0.7|7.6|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.6|0.7|0.0175
91623985|NCT00476996|183140356|SUPERIORITY||Weighted Difference|4.3||||0.0134|TWO_SIDED|95.0|0.9|7.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.8|0.9|0.0134
91623986|NCT00476996|183140356|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.8|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.8|6.2|< 0.0001
91623987|NCT00476996|183140356|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.7|6.2|< 0.0001
91623988|NCT00476996|183140357|SUPERIORITY||Adjusted Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.3|-0.8|< 0.0001
91623989|NCT00476996|183140357|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.6|-1.1|< 0.0001
91713784|NCT02849587|183319121|OTHER|Spearman's correlation||||||0.053|||||||Spearman's correlation|||||||0.053
91713785|NCT02849587|183319122|OTHER|Spearman's correlation||||||0.3|||||||Spearman's correlation|||||||0.300
91713786|NCT02849587|183319122|OTHER|Spearman's correlation||||||0.038|||||||Spearman's correlation|||||||0.038
91661800|NCT01175018|183218428|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661801|NCT01175018|183218429|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
91661802|NCT01175018|183218430|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
91661803|NCT01175018|183218431|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661804|NCT01175018|183218432|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
91661805|NCT01175018|183218433|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
91661806|NCT01175018|183218434|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
91661807|NCT01175018|183218435|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661808|NCT01175018|183218436|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91481376|NCT00509262|182835968|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.|Difference in least squares mean|-0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-0.29|0.06|||ANCOVA||Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.|||0.06|-0.29|
91481377|NCT00509262|182835969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8||||0.001|TWO_SIDED|95.0|-17.1|-4.8|||Miettirnen& Nurminen method||Miettirnen \& Nurminen method stratified by renal insufficiency stratum at Visit 4/Week -2 (moderate or severe) \& prior diabetes pharmacotherapy|||-4.8|-17.1|0.001
91481378|NCT00509262|182835970|SUPERIORITY_OR_OTHER||Difference in least squares mean|7.1|STANDARD_DEVIATION|38.3|||TWO_SIDED|95.0|-1.9|16.1|||ANCOVA||Analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline Fasting Plasma Glucose.|||16.1|-1.9|
91661809|NCT01175018|183218437|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661810|NCT01175018|183218438|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661811|NCT01175018|183218439|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661812|NCT01175018|183218440|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661813|NCT01175018|183218441|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91661814|NCT00840073|183218454|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.0||||||90.0|85.13|108.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.27|85.13|
91661815|NCT00840073|183218455|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.81||||||90.0|96.72|111.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.41|96.72|
91661816|NCT00840073|183218456|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|102.37||||||90.0|97.34|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|97.34|
91661817|NCT00840073|183218457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.76||||||90.0|100.08|107.57|||||Informational Purposes Only|||107.57|100.08|
91661818|NCT00840073|183218458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|103.34||||||90.0|100.84|105.92|||||Informational Purposes Only|||105.92|100.84|
91661819|NCT00835263|183218470|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.23||||||90.0|100.78|105.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.73|100.78|
91661820|NCT00835263|183218471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.31||||||90.0|100.75|105.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.93|100.75|
91661821|NCT00835263|183218472|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|102.14||||||90.0|100.06|104.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.26|100.06|
91661822|NCT01020474|183218487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.121|TWO_SIDED|95.0|-1.51|0.18||Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.|ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.18|-1.51|0.121
91661823|NCT01020474|183218488|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18||||0.655|TWO_SIDED|95.0|-1.0|0.63|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.63|-1.00|0.655
91661824|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07||||0.842|TWO_SIDED|95.0|-0.75|0.61|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.61|-0.75|0.842
91661825|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.07|TWO_SIDED|95.0|-1.32|0.05|||Mixed Models Analysis|||Statistical analysis of Week 2||0.05|-1.32|0.070
91661826|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.019|TWO_SIDED|95.0|-1.51|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 3.||-0.14|-1.51|0.019
91661827|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.011|TWO_SIDED|95.0|-1.59|-0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||-0.21|-1.59|0.011
91661828|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.056|TWO_SIDED|95.0|-1.38|0.02|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.02|-1.38|0.056
91713787|NCT02849587|183319122|OTHER|Spearman's correlation||||||0.175|||||||Spearman's correlation|||||||0.175
91661829|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.008|TWO_SIDED|95.0|-1.66|-0.26|||Mixed Models Analysis|||Statistical analysis of Week 6.||-0.26|-1.66|0.008
91661830|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.89||||0.013|TWO_SIDED|95.0|-1.6|-0.19|||Mixed Models Analysis|||Statistical analysis of Week 7.||-0.19|-1.60|0.013
91661831|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06||||0.004|TWO_SIDED|95.0|-1.77|-0.35|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.35|-1.77|0.004
91661832|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.95||||0.009|TWO_SIDED|95.0|-1.67|-0.24|||Mixed Models Analysis|||Statistical analysis of Week 9.||-0.24|-1.67|0.009
91481379|NCT00509262|182835971|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|STANDARD_DEVIATION|3.8|<|0.001|TWO_SIDED|95.0|-2.6|-1.0|||ANCOVA||Analysis of covariance with terms of treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline body weight.|||-1.0|-2.6|<0.001
91661833|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.008|TWO_SIDED|95.0|-1.69|-0.25|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.25|-1.69|0.008
91661834|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.021|TWO_SIDED|95.0|-1.59|-0.13|||Mixed Models Analysis|||Statistical analysis of Week 11.||-0.13|-1.59|0.021
91713788|NCT03421379|183319156|NON_INFERIORITY|The pre-defined non-inferiority margin is (10%)|Treatment Difference Wald's Method|0.0|||||TWO_SIDED|95.0|-1.47|1.47||||||||1.47|-1.47|
91481380|NCT01244490|182835995|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-11.9|-5.8|||ANCOVA|||||-5.8|-11.9|<0.001
91661835|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.01|TWO_SIDED|95.0|-1.71|-0.23|||Mixed Models Analysis|||Statistical analysis of Week 12.||-0.23|-1.71|0.010
91481381|NCT01244490|182835995|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-3.8||||0.017|TWO_SIDED|95.0|-6.8|-0.7|||ANCOVA|||||-0.7|-6.8|0.017
91527729|NCT01976364|182930502|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
91661836|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.49|0.0|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.00|-1.49|0.051
91661837|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.02|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 14.||-0.14|-1.66|0.020
91661838|NCT01020474|183218489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.06|TWO_SIDED|95.0|-1.51|0.03|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.03|-1.51|0.060
91661839|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.54|TWO_SIDED|95.0|-0.9|0.47|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.47|-0.90|0.540
91661840|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.593|TWO_SIDED|95.0|-0.87|0.5|||Mixed Models Analysis|||Statistical analysis of Week 2||0.50|-0.87|0.593
91661841|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.206|TWO_SIDED|95.0|-1.13|0.25|||Mixed Models Analysis|||Statistical analysis of Week 3.||0.25|-1.13|0.206
91661842|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||0.168|TWO_SIDED|95.0|-1.18|0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||0.21|-1.18|0.168
91481382|NCT01244490|182835996|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.4|||Cochran-Mantel-Haenszel|||||36.4|11.1|<0.001
91481383|NCT01244490|182835996|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|12.1||||0.024|TWO_SIDED|95.0|-0.9|25.1|||Cochran-Mantel-Haenszel|||||25.1|-0.9|0.024
91481384|NCT01244490|182835997|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.217||||0.003|TWO_SIDED|95.0|-0.358|-0.076|||ANCOVA|||||-0.076|-0.358|0.003
91481385|NCT01244490|182835997|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.162||||0.026|TWO_SIDED|95.0|-0.305|-0.019|||ANCOVA|||||-0.019|-0.305|0.026
91481386|NCT01244490|182835998|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.209||||0.006|TWO_SIDED|95.0|-0.358|-0.059|||ANCOVA|||||-0.059|-0.358|0.006
91481387|NCT01244490|182835998|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.09||||0.242|TWO_SIDED|95.0|-0.241|0.061|||ANCOVA|||||0.061|-0.241|0.242
91661843|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38||||0.28|TWO_SIDED|95.0|-1.08|0.32|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.32|-1.08|0.280
91661844|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.075|TWO_SIDED|95.0|-1.34|0.06|||Mixed Models Analysis|||Statistical analysis of Week 6.||0.06|-1.34|0.075
91661845|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.168|TWO_SIDED|95.0|-1.21|0.21|||Mixed Models Analysis|||Statistical analysis of Week 7.||0.21|-1.21|0.168
91661846|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01||||0.006|TWO_SIDED|95.0|-1.73|-0.3|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.30|-1.73|0.006
91661847|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.57||||0.12|TWO_SIDED|95.0|-1.29|0.15|||Mixed Models Analysis|||Statistical analysis of Week 9.||0.15|-1.29|0.120
91661848|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.037|TWO_SIDED|95.0|-1.49|-0.05|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.05|-1.49|0.037
91661849|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.3|||Mixed Models Analysis|||Statistical analysis of Week 11.||0.30|-1.16|0.246
91661850|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.105|TWO_SIDED|95.0|-1.36|0.13|||Mixed Models Analysis|||Statistical analysis of Week 12.||0.13|-1.36|0.105
91527730|NCT01976364|182930502|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.3|
91623990|NCT00476996|183140357|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.7|-1.2|< 0.0001
91623991|NCT00476996|183140357|SUPERIORITY||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.9|-1.5|< 0.0001
91623992|NCT00476996|183140358|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.85|3.66|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||3.66|1.85|< 0.0001
91623993|NCT00476996|183140358|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.0001|TWO_SIDED|95.0|2.49|4.91|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||4.91|2.49|< 0.0001
91623994|NCT00476996|183140358|SUPERIORITY||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.93|5.96|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||5.96|2.93|< 0.0001
91661851|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.376|TWO_SIDED|95.0|-1.09|0.41|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.41|-1.09|0.376
91661852|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.285|TWO_SIDED|95.0|-1.18|0.35|||Mixed Models Analysis|||Statistical analysis of Week 14.||0.35|-1.18|0.285
91661853|NCT01020474|183218490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17||||0.663|TWO_SIDED|95.0|-0.95|0.61|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.61|-0.95|0.663
91661854|NCT01020474|183218491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.037|TWO_SIDED|95.0|-1.68|-0.05|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||-0.05|-1.68|0.037
91661855|NCT01020474|183218492|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.694|TWO_SIDED|95.0|0.53|2.58|||Regression, Logistic|||Statistical analysis at Week 15.||2.58|0.53|0.694
91661856|NCT01020474|183218493|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.162|TWO_SIDED|95.0|0.72|7.02|||Regression, Logistic|||Statistical analysis at Week 15.||7.02|0.72|0.162
91623995|NCT00476996|183140358|SUPERIORITY||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.54|7.18|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||7.18|3.54|< 0.0001
91623996|NCT00476996|183140359|SUPERIORITY||Weighted Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||19.1|7.4|< 0.0001
91623997|NCT00476996|183140359|SUPERIORITY||Weighted Difference|16.2|||<|0.0001|TWO_SIDED|95.0|10.2|22.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||22.1|10.2|< 0.0001
91623998|NCT00476996|183140359|SUPERIORITY||Weighted Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.9|25.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||25.6|12.9|< 0.0001
91623999|NCT00476996|183140359|SUPERIORITY||Weighted Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.5|27.1|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||27.1|14.5|< 0.0001
91624000|NCT00476996|183140360|SUPERIORITY||Weighted Difference|4.6||||0.0203|TWO_SIDED|95.0|0.7|8.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||8.5|0.7|0.0203
91624001|NCT00476996|183140360|SUPERIORITY||Weighted Difference|6.7||||0.0014|TWO_SIDED|95.0|2.6|10.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||10.8|2.6|0.0014
91624002|NCT00476996|183140360|SUPERIORITY||Weighted Difference|6.6||||0.0042|TWO_SIDED|95.0|2.1|11.2|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||11.2|2.1|0.0042
91624003|NCT00476996|183140360|SUPERIORITY||Weighted Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.2|18.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||18.6|8.2|< 0.0001
91624004|NCT00476996|183140361|SUPERIORITY||Weighted Difference|19.4|||<|0.0001|TWO_SIDED|95.0|11.3|27.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.5|11.3|< 0.0001
91661857|NCT01020474|183218494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Cochran-Mantel-Haenszel|P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.||Statistical analysis at Week 15.||||0.013
91624005|NCT00476996|183140361|SUPERIORITY||Weighted Difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.8|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|16.8|< 0.0001
91624006|NCT00476996|183140361|SUPERIORITY||Weighted Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.5|34.9|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||34.9|19.5|< 0.0001
91661858|NCT02964039|183218530|SUPERIORITY|||||||0.047||||||A priori threshold: 0.05|ANOVA|0.047 is the main effect of group from a 2-way ANOVA that also included time (p=0.77) as a within-subjects factor.||||||0.047
91661859|NCT02964039|183218531|SUPERIORITY|||||||0.16||||||A priori threshold: 0.05|ANOVA|0.16 is the main effect of group from a 2-way ANOVA that also included time (p=0.023) as a within-subjects factor.||||||0.16
91661860|NCT02964039|183218532|SUPERIORITY|||||||0.64||||||A priori threshold: 0.05|ANOVA|0.64 is the main effect of group from a 2-way ANOVA that also included time (p=0.024) as a within-subjects factor.||||||0.64
91661861|NCT02964039|183218533|SUPERIORITY|||||||0.92||||||A priori threshold: 0.92|ANOVA|0.92 is the main effect of group from a 2-way ANOVA that also included time (p=0.076) as a within-subjects factor.||||||0.92
91661862|NCT02964039|183218534|SUPERIORITY||||||>=|0.22||||||A priori threshold: 0.05|Mixed Models Analysis|We compared incident rates assuming a negative binomial distribution with leas squares means estimates predicted via generalized linear model.||||||>=0.22
91661863|NCT02964039|183218535|SUPERIORITY|||||||0.99||||||A priori threshold: 0.05|Chi-squared|||||||0.99
91661864|NCT00840411|183218585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.0||||||90.0|93.3|107.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.1|93.3|
91661865|NCT00840411|183218586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|86.5||||||90.0|80.1|93.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.4|80.1|
91661866|NCT00840411|183218587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|87.2||||||90.0|81.0|93.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.8|81.0|
91661867|NCT00651820|183218607|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Paired-Prentice Wilcoxon (PPW)|Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.||Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure||||<0.05
91661868|NCT00651820|183218608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
91661869|NCT00651820|183218608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
91661870|NCT00119015|183218667|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8
91624007|NCT00476996|183140361|SUPERIORITY||Weighted Difference|27.6|||<|0.0001|TWO_SIDED|95.0|20.0|35.3|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||35.3|20.0|< 0.0001
91661871|NCT00119015|183218668|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.70
91661872|NCT00119015|183218669|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
91661873|NCT00119015|183218670|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.48
91661874|NCT00119015|183218671|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.99
91661875|NCT00787254|183218680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.14|0.4499|||Log Rank|||||0.4499|0.1400|<0.0001
91661876|NCT00787254|183218681|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
91661877|NCT00787254|183218682|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0041
91661878|NCT00787254|183218683|SUPERIORITY_OR_OTHER|||||||0.0652||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0652
91661879|NCT00787254|183218684|SUPERIORITY_OR_OTHER|||||||0.9836||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9836
91661880|NCT00787254|183218686|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
91661881|NCT00787254|183218687|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0161
91661882|NCT00787254|183218688|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0068
91624008|NCT00676793|183140386|SUPERIORITY_OR_OTHER||||||=|0.078||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.078
91624009|NCT00676793|183140387|SUPERIORITY_OR_OTHER||||||=|0.094||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.094
91624010|NCT01617187|183140456|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) means difference|-1.3|STANDARD_ERROR_OF_MEAN|2.46||0.6043|TWO_SIDED|95.0|-6.1|3.6||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|Mixed Model Repeated Measures (MMRM)||Asenapine 2.5 mg BID minus Placebo BID|||3.6|-6.1|0.6043
91624011|NCT01617187|183140456|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|2.32||0.0356|TWO_SIDED|95.0|-10.1|-1.0||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-1.0|-10.1|0.0356
91661883|NCT00787254|183218689|SUPERIORITY_OR_OTHER|||||||0.2363||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2363
91661884|NCT00787254|183218691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91661885|NCT00787254|183218692|SUPERIORITY_OR_OTHER|||||||0.4788||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4788
91661886|NCT00787254|183218693|SUPERIORITY_OR_OTHER|||||||0.6607||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6607
91661887|NCT00787254|183218694|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8811
91661888|NCT00787254|183218695|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
91661889|NCT00787254|183218697|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2060
91661890|NCT00787254|183218698|SUPERIORITY_OR_OTHER|||||||0.5099||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5099
91661891|NCT00787254|183218699|SUPERIORITY_OR_OTHER|||||||0.7794||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7794
91661892|NCT00787254|183218700|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
91661893|NCT00787254|183218702|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6980
91661894|NCT00787254|183218703|SUPERIORITY_OR_OTHER|||||||0.4599||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4599
91661895|NCT00787254|183218704|SUPERIORITY_OR_OTHER|||||||0.0355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0355
91661896|NCT00787254|183218705|SUPERIORITY_OR_OTHER|||||||0.7325||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7325
91661897|NCT00787254|183218707|SUPERIORITY_OR_OTHER|||||||0.8262||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8262
91661898|NCT00787254|183218708|SUPERIORITY_OR_OTHER|||||||0.7244||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7244
91661899|NCT00787254|183218709|SUPERIORITY_OR_OTHER|||||||0.9566||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9566
91661900|NCT00787254|183218710|SUPERIORITY_OR_OTHER|||||||0.2008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2008
91661901|NCT00787254|183218712|SUPERIORITY_OR_OTHER|||||||0.0703||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0703
91624012|NCT01617187|183140456|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.4|STANDARD_ERROR_OF_MEAN|2.86||0.0587|TWO_SIDED|95.0|-11.1|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-11.1|0.0587
91624013|NCT01617187|183140457|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.9083|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.3|-0.3|0.9083
91624014|NCT01617187|183140457|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0601|TWO_SIDED|95.0|-0.6|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.0|-0.6|0.0601
91624015|NCT01617187|183140457|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3898|TWO_SIDED|95.0|-0.5|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-0.5|0.3898
91624016|NCT01617187|183140458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.3700
91624017|NCT01617187|183140458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1708||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.1708
91624018|NCT01617187|183140458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||||||0.2620
91624019|NCT01617187|183140459|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0491|TWO_SIDED|95.0|-2.4|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 2.5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.4|0.0491
91661902|NCT00787254|183218713|SUPERIORITY_OR_OTHER|||||||0.3046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3046
91624020|NCT01617187|183140459|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.0491|TWO_SIDED|95.0|-2.3|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.3|0.0491
91624021|NCT01617187|183140459|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.51||0.0567|TWO_SIDED|95.0|0.0|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|||2.0|-0.0|0.0567
91624022|NCT01617187|183140459|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0391|TWO_SIDED|95.0|0.0|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|||1.9|0.0|0.0391
91624023|NCT01617187|183140459|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|2.2|STANDARD_ERROR_OF_MEAN|0.58||0.0003|TWO_SIDED|95.0|1.0|3.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||3.3|1.0|0.0003
91624024|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.8|STANDARD_ERROR_OF_MEAN|1.09||0.4849|TWO_SIDED|95.0|-1.4|2.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||2.9|-1.4|0.4849
91624025|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.06||0.8902|TWO_SIDED|95.0|-2.2|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.9|-2.2|0.8902
91624026|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.36||0.5826|TWO_SIDED|95.0|-3.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.9|-3.4|0.5826
91624027|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.61||0.9271|TWO_SIDED|95.0|-3.3|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||3.0|-3.3|0.9271
91624028|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|1.56||0.1902|TWO_SIDED|95.0|-5.1|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||1.0|-5.1|0.1902
91624029|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.271|TWO_SIDED|95.0|-6.2|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.7|-6.2|0.2710
91624030|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.79||0.6773|TWO_SIDED|95.0|-2.8|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||4.3|-2.8|0.6773
91624031|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.72||0.2895|TWO_SIDED|95.0|-5.2|1.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.6|-5.2|0.2895
91481388|NCT01244490|182835999|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||<0.001
91624032|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.7|STANDARD_ERROR_OF_MEAN|2.18||0.4261|TWO_SIDED|95.0|-6.0|2.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||2.6|-6.0|0.4261
91624033|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.3|STANDARD_ERROR_OF_MEAN|2.13||0.5505|TWO_SIDED|95.0|-2.9|5.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||5.5|-2.9|0.5505
91624034|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.03||0.4286|TWO_SIDED|95.0|-5.6|2.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||2.4|-5.6|0.4286
91624035|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|2.56||0.4423|TWO_SIDED|95.0|-7.0|3.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||3.1|-7.0|0.4423
91661903|NCT00787254|183218714|SUPERIORITY_OR_OTHER|||||||0.7121||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7121
91661904|NCT00787254|183218715|SUPERIORITY_OR_OTHER|||||||0.1522||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1522
91661905|NCT00787254|183218717|SUPERIORITY_OR_OTHER|||||||0.5328||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5328
91661906|NCT00787254|183218718|SUPERIORITY_OR_OTHER|||||||0.7223||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7223
91661907|NCT00787254|183218719|SUPERIORITY_OR_OTHER|||||||0.3117||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3117
91661908|NCT00787254|183218720|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||t-test, 2 sided|||||||0.4344
91624036|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|3.2|STANDARD_ERROR_OF_MEAN|2.3||0.1691|TWO_SIDED|95.0|-1.4|7.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||7.7|-1.4|0.1691
91624037|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.17||0.4682|TWO_SIDED|95.0|-5.8|2.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||2.7|-5.8|0.4682
91624038|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|2.71||0.4961|TWO_SIDED|95.0|-7.2|3.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||3.5|-7.2|0.4961
91624039|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.26||0.4697|TWO_SIDED|95.0|-6.1|2.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||2.8|-6.1|0.4697
91624040|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|2.14||0.0947|TWO_SIDED|95.0|-7.8|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.6|-7.8|0.0947
91624041|NCT01617187|183140460|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.9|STANDARD_ERROR_OF_MEAN|2.68||0.0675|TWO_SIDED|95.0|-10.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.4|-10.2|0.0675
91624042|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
91624043|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
91661909|NCT00787254|183218722|SUPERIORITY_OR_OTHER|||||||0.1571||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1571
91661910|NCT00787254|183218723|SUPERIORITY_OR_OTHER|||||||0.2503||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2503
91624044|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.2850
91624045|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.3290
91624046|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6938||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.6938
91624047|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1105
91661911|NCT00787254|183218724|SUPERIORITY_OR_OTHER|||||||0.4028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4028
91624048|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6804||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6804
91624049|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9704||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.9704
91624050|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6604||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6604
91624051|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2447||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.2447
91624052|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4834||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4834
91624053|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9189||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.9189
91624054|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.437||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.4370
91624055|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2894||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.2894
91624056|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6953||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.6953
91624057|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4892||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.4892
91624058|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1954||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.1954
91661912|NCT00787254|183218725|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
91661913|NCT00526188|183218741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.46||||||95.0|6.0|12.93|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.||12.93|6.00|
91661914|NCT00526188|183218742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.81||||||95.0|1.84|7.78|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.||7.78|1.84|
91661915|NCT00526188|183218743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.36||||||95.0|7.45|15.28|||Test performed based on the 95% CI||Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI|Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.||15.28|7.45|
91481389|NCT01244490|182835999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||0.196
91624059|NCT01617187|183140461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.7990
91624060|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.4255|TWO_SIDED|95.0|-0.1|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.2|-0.1|0.4255
91624061|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9564|TWO_SIDED|95.0|-0.1|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.1|-0.1|0.9564
91624062|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6363|TWO_SIDED|95.0|-0.2|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.1|-0.2|0.6363
91624063|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8759|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.8759
91624064|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9598|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9598
91624065|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9789|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9789
91624066|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.4671|TWO_SIDED|95.0|-0.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.1|-0.3|0.4671
91624067|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6359|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-0.3|0.6359
91481390|NCT01244490|182836001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165||||0.001|TWO_SIDED|95.0|-0.266|-0.064||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.064|-0.266|0.001
91481391|NCT01244490|182836001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.104||||0.048|TWO_SIDED|95.0|-0.207|-0.001||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.001|-0.207|0.048
91624068|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5454|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.2|-0.4|0.5454
91624069|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4188|TWO_SIDED|95.0|-0.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.4|-0.2|0.4188
91624070|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5318|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.2|-0.3|0.5318
91624071|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5683|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.2|-0.4|0.5683
91624072|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2972|TWO_SIDED|95.0|-0.1|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||0.4|-0.1|0.2972
91624073|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.482|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.2|-0.4|0.4820
91624074|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9901|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.3|-0.3|0.9901
91624075|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6682|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.2|-0.4|0.6682
91624076|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1111|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.1111
91624077|NCT01617187|183140462|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.24|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.2400
91624078|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6205||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.6205
91624079|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.4829
91624080|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3945||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.3945
91624081|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4076||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.4076
91624082|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.9690
91624083|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1170
91624084|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.5088
91624085|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3426||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.3426
91624086|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0762||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.0762
91624087|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5531||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.5531
91481392|NCT01244490|182836002|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.211||||0.043|TWO_SIDED|95.0|-0.416|-0.007||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.007|-0.416|0.043
91481393|NCT01244490|182836002|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.125||||0.231|TWO_SIDED|95.0|-0.331|0.08||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.080|-0.331|0.231
91624088|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4875||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4875
91624089|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.0692
91624090|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7482||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.7482
91624091|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8037||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.8037
91624092|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0859||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.0859
91624093|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.585||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.5850
91624094|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9698||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.9698
91624095|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0132||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.0132
91624096|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7129||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.7129
91624097|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.5074
91624098|NCT01617187|183140463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.0040
91624099|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8829|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.8829
91661916|NCT00373256|183218860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6299||||0.9986|TWO_SIDED|95.0|1.1793|2.2527||p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.|Log Rank||Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.|||2.2527|1.1793|0.9986
91481394|NCT01244490|182836003|SUPERIORITY_OR_OTHER_LEGACY||Diiference in Least Squares Mean|-0.229|||<|0.001|TWO_SIDED|95.0|-0.364|-0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.094|-0.364|<0.001
91481395|NCT01244490|182836003|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.181||||0.009|TWO_SIDED|95.0|-0.317|-0.045||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.045|-0.317|0.009
91481396|NCT01244490|182836004|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.094||||0.096|TWO_SIDED|95.0|-0.204|0.017||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.017|-0.204|0.096
91624100|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5488|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5488
91624101|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.783|TWO_SIDED|95.0|-1.1|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.1|0.7830
91624102|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.45||0.807|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.8|-1.0|0.8070
91624103|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.528|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5280
91624104|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.57||0.4025|TWO_SIDED|95.0|-1.6|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.6|0.4025
91624105|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6471|TWO_SIDED|95.0|-0.8|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.2|-0.8|0.6471
91481397|NCT01244490|182836004|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.067||||0.242|TWO_SIDED|95.0|-0.18|0.046||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.046|-0.180|0.242
91624106|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2504|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.5|0.2504
91624107|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.9223|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.9223
91624108|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8839|TWO_SIDED|95.0|-1.0|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-1.0|0.8839
91624109|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8077|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.2|0.8077
91624110|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.68||0.6216|TWO_SIDED|95.0|-1.0|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-1.0|0.6216
91624111|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4248|TWO_SIDED|95.0|-0.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.7|-0.7|0.4248
91624112|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7667|TWO_SIDED|95.0|-1.3|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.3|0.7667
91481398|NCT01244490|182836005|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.049||||0.5|TWO_SIDED|95.0|-0.191|0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.094|-0.191|0.500
91624113|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.6282|TWO_SIDED|95.0|-1.1|1.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.8|-1.1|0.6282
91624114|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.315|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.6|-1.9|0.3150
91624115|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61||0.1908|TWO_SIDED|95.0|-2.0|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-2.0|0.1908
91624116|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.77||0.3128|TWO_SIDED|95.0|-2.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.7|-2.3|0.3128
91624117|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8812|TWO_SIDED|95.0|-1.5|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.3|-1.5|0.8812
91624118|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.1143|TWO_SIDED|95.0|-2.4|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-2.4|0.1143
91624119|NCT01617187|183140464|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4418|TWO_SIDED|95.0|-2.3|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.0|-2.3|0.4418
91624120|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.216|TWO_SIDED|95.0|-0.3|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.3|-0.3|0.2160
91624121|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.9494|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.9494
91481399|NCT01244490|182836005|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.078||||0.288|TWO_SIDED|95.0|-0.222|0.066||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.066|-0.222|0.288
91624122|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1834|TWO_SIDED|95.0|-1.6|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.3|-1.6|0.1834
91661917|NCT00373256|183218861|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.2|||||TWO_SIDED|95.0|26.4|38.5||||||||38.5|26.4|
91624123|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6347|TWO_SIDED|95.0|-0.8|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.3|-0.8|0.6347
91481400|NCT01244490|182836006|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.233||||0.001|TWO_SIDED|95.0|-0.374|-0.092||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.092|-0.374|0.001
91624124|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6917|TWO_SIDED|95.0|-1.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.8|-1.2|0.6917
91624125|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.66||0.1431|TWO_SIDED|95.0|-2.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.3|-2.3|0.1431
91624126|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6267|TWO_SIDED|95.0|-0.9|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-0.9|0.6267
91624127|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.726|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-1.3|0.7260
91624128|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.74||0.3326|TWO_SIDED|95.0|-2.2|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-2.2|0.3326
91624129|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.4575|TWO_SIDED|95.0|-0.9|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.9|-0.9|0.4575
91624130|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.493|TWO_SIDED|95.0|-1.8|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.8|0.4930
91624131|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.86||0.1886|TWO_SIDED|95.0|-2.8|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.6|-2.8|0.1886
91624132|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.2643|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2643
91624133|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.76||0.3516|TWO_SIDED|95.0|-2.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.8|-2.2|0.3516
91624134|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.94||0.2068|TWO_SIDED|95.0|-3.1|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.7|-3.1|0.2068
91624135|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.7284|TWO_SIDED|95.0|-1.3|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.9|-1.3|0.7284
91624136|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.2698|TWO_SIDED|95.0|-2.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-2.4|0.2698
91624137|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.96||0.151|TWO_SIDED|95.0|-3.3|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-3.3|0.1510
91624138|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.88||0.8039|TWO_SIDED|95.0|-2.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.5|-2.0|0.8039
91661918|NCT00373256|183218861|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.1|||||TWO_SIDED|95.0|26.3|38.4||||||||38.4|26.3|
91661919|NCT00373256|183218864|SUPERIORITY_OR_OTHER||Percentage|76.8|||||TWO_SIDED|95.0|68.7|83.0||||||1 year||83.0|68.7|
91624139|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0306|TWO_SIDED|95.0|-3.5|-0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.2|-3.5|0.0306
91624140|NCT01617187|183140465|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.0406|TWO_SIDED|95.0|-4.1|-0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.1|-4.1|0.0406
91624141|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7819|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-1.1|0.7819
91624142|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.703|TWO_SIDED|95.0|-1.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-1.5|0.7030
91624143|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.952|TWO_SIDED|95.0|-1.7|1.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.6|-1.7|0.9520
91624144|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7907|TWO_SIDED|95.0|-2.1|1.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.6|-2.1|0.7907
91624145|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.91||0.1391|TWO_SIDED|95.0|-3.1|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-3.1|0.1391
91624146|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.18||0.4901|TWO_SIDED|95.0|-3.1|1.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.5|-3.1|0.4901
91624147|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8079|TWO_SIDED|95.0|-1.7|2.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||2.2|-1.7|0.8079
91624148|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.95||0.3889|TWO_SIDED|95.0|-2.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.1|-2.7|0.3889
91624149|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.21||0.3907|TWO_SIDED|95.0|-3.4|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-3.4|0.3907
91624150|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.15||0.5363|TWO_SIDED|95.0|-1.5|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||3.0|-1.5|0.5363
91624151|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|1.09||0.5075|TWO_SIDED|95.0|-2.9|1.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.4|-2.9|0.5075
91624152|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.38||0.4526|TWO_SIDED|95.0|-3.7|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-3.7|0.4526
91624153|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.8|STANDARD_ERROR_OF_MEAN|1.26||0.1548|TWO_SIDED|95.0|-0.7|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||4.3|-0.7|0.1548
91624154|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|1.19||0.6589|TWO_SIDED|95.0|-2.9|1.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.8|-2.9|0.6589
91624155|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.48||0.5171|TWO_SIDED|95.0|-3.9|2.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||2.0|-3.9|0.5171
91624156|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.3133|TWO_SIDED|95.0|-3.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.2|-3.6|0.3133
91624157|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.13||0.1723|TWO_SIDED|95.0|-3.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-3.8|0.1723
91624158|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|1.42||0.0663|TWO_SIDED|95.0|-5.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.2|-5.4|0.0663
91624159|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.32||0.5128|TWO_SIDED|95.0|-3.5|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.7|-3.5|0.5128
91661920|NCT00373256|183218864|SUPERIORITY_OR_OTHER||Percentage|35.5|||||TWO_SIDED|95.0|20.9|50.3||||||2 years||50.3|20.9|
91624160|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|1.24||0.0842|TWO_SIDED|95.0|-4.6|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-4.6|0.0842
91624161|NCT01617187|183140466|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.52||0.1217|TWO_SIDED|95.0|-5.4|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.6|-5.4|0.1217
91624162|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0584|TWO_SIDED|95.0|0.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-0.0|0.0584
91624163|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5197|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5197
91624164|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.9693|TWO_SIDED|95.0|-0.9|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.0|-0.9|0.9693
91624165|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.56||0.6161|TWO_SIDED|95.0|-0.8|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.4|-0.8|0.6161
91624166|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.788|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-1.2|0.7880
91661921|NCT00373256|183218864|SUPERIORITY_OR_OTHER||Percentage|83.7|||||TWO_SIDED|95.0|76.0|89.1||||||1 year||89.1|76.0|
91661922|NCT00373256|183218864|SUPERIORITY_OR_OTHER||Percentage|61.0|||||TWO_SIDED|95.0|43.2|74.7||||||2 years||74.7|43.2|
91661923|NCT02925884|183218903|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Decreased Cognitive Functions.||||0.011
91661924|NCT02925884|183218903|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Eyestrain.||||<0.001
91661925|NCT02925884|183218903|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Physical Discomfort.||||0.009
91624167|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.5526|TWO_SIDED|95.0|-1.8|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.0|-1.8|0.5526
91624168|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.67||0.7647|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-1.1|0.7647
91624169|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.64||0.89|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.8900
91661926|NCT02925884|183218903|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Deceased Visual Function.||||<0.001
91525092|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.218|=|0.006|TWO_SIDED|95.0|-0.99|-0.12||1-sided p-value was reported.|MMRM|||Muscle Cramps|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.99|=0.006
91624170|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.7097|TWO_SIDED|95.0|-1.9|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.9|0.7097
91624171|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4601|TWO_SIDED|95.0|-0.9|2.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||2.1|-0.9|0.4601
91624172|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.72||0.6288|TWO_SIDED|95.0|-1.8|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.1|-1.8|0.6288
91624173|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.91||0.6099|TWO_SIDED|95.0|-2.3|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.3|-2.3|0.6099
91661927|NCT02925884|183218903|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Poor Balance.||||0.28
91661928|NCT02925884|183218904|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
91525093|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.213|=|0.007|TWO_SIDED|95.0|-0.96|-0.12||1-sided p-value was reported.|MMRM|||Tingling|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.96|=0.007
91624174|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.279|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2790
91624175|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.77||0.4253|TWO_SIDED|95.0|-2.1|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.9|-2.1|0.4253
91624176|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.96||0.3014|TWO_SIDED|95.0|-2.9|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.9|-2.9|0.3014
91624177|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.7|-1.7|0.9720
91624178|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4758|TWO_SIDED|95.0|-2.2|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||1.0|-2.2|0.4758
91661929|NCT02925884|183218905|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Red Color Perception.||||0.009
91661930|NCT02925884|183218905|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Green Color Perception.||||0.446
91661931|NCT02925884|183218905|SUPERIORITY|||||||0.953|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Blue Color Perception.||||0.953
91661932|NCT02925884|183218906|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
91661933|NCT02925884|183218907|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
91661934|NCT02925884|183218908|SUPERIORITY|||||||0.343|||||||Mixed Models Analysis|||||||0.343
91661935|NCT02925884|183218909|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||||||0.489
91661936|NCT02925884|183218910|SUPERIORITY|||||||0.885|||||||Mixed Models Analysis|||||||0.885
91661937|NCT02925884|183218911|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91661938|NCT02925884|183218912|SUPERIORITY|||||||0.359|||||||Mixed Models Analysis|||||||0.359
91661939|NCT04516434|183218913|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
91661940|NCT04516434|183218913|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
91661941|NCT04516434|183218914|OTHER|Descriptive analysis||||||0.08|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.08
91661942|NCT04516434|183218914|OTHER|Descriptive analysis||||||0.045|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.045
91661943|NCT04516434|183218916|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
91661944|NCT04516434|183218916|OTHER|Descriptive analysis||||||0.41|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.41
91624179|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.03||0.4419|TWO_SIDED|95.0|-2.8|1.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.2|-2.8|0.4419
91624180|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.91||0.4762|TWO_SIDED|95.0|-2.4|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-2.4|0.4762
91624181|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.86||0.1046|TWO_SIDED|95.0|-3.1|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-3.1|0.1046
91624182|NCT01617187|183140467|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1411|TWO_SIDED|95.0|-3.7|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.5|-3.7|0.1411
91624183|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2754|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2754
91624184|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.8|0.8500
91624185|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8439|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.9|-1.1|0.8439
91624186|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4741|TWO_SIDED|95.0|-1.4|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.4|0.4741
91624187|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2158|TWO_SIDED|95.0|-1.6|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-1.6|0.2158
91624188|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.506|TWO_SIDED|95.0|-1.7|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.8|-1.7|0.5060
91624189|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9956|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-1.1|0.9956
91525094|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.231|=|0.02|TWO_SIDED|95.0|-0.94|-0.02||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.02|-0.94|=0.020
91624190|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.1624|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.3|-1.8|0.1624
91624191|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7662|TWO_SIDED|95.0|-1.5|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.1|-1.5|0.7662
91661945|NCT04516434|183218916|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
91624192|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.8363|TWO_SIDED|95.0|-1.3|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.1|-1.3|0.8363
91624193|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.2388|TWO_SIDED|95.0|-1.8|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.5|-1.8|0.2388
91624194|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.9435|TWO_SIDED|95.0|-1.5|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-1.5|0.9435
91624195|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4267|TWO_SIDED|95.0|-0.8|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.9|-0.8|0.4267
91624196|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.681|TWO_SIDED|95.0|-1.6|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.6|0.6810
91624197|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.82||0.7673|TWO_SIDED|95.0|-1.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.9|-1.4|0.7673
91624198|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.483|TWO_SIDED|95.0|-1.9|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.9|-1.9|0.4830
91624199|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2128|TWO_SIDED|95.0|-2.1|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.5|-2.1|0.2128
91624200|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1756|TWO_SIDED|95.0|-2.8|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-2.8|0.1756
91624201|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.4246|TWO_SIDED|95.0|-0.8|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||2.0|-0.8|0.4246
91624202|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.68||0.2873|TWO_SIDED|95.0|-2.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.6|-2.1|0.2873
91661946|NCT04516434|183218916|OTHER|Descriptive analysis||||||0.01|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.01
91661947|NCT04516434|183218917|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
91661948|NCT04516434|183218917|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
91661949|NCT04516434|183218918|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
91481401|NCT01244490|182836006|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.111||||0.124|TWO_SIDED|95.0|-0.253|0.031||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.031|-0.253|0.124
91481402|NCT01244490|182836007|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.056||||0.139|TWO_SIDED|95.0|-0.131|0.018||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.018|-0.131|0.139
91481403|NCT01244490|182836007|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.039||||0.315|TWO_SIDED|95.0|-0.115|0.037||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.037|-0.115|0.315
91481404|NCT00971620|182836012|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|-2.0|4.0|||Wilcoxon rank sum test|||||4.00|-2.00|.70
91481405|NCT00971620|182836014|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon rank sum test|||||||.06
91481406|NCT00971620|182836015|SUPERIORITY_OR_OTHER|||||||0.007|||||||WIlcoxon rank sum test|||||||.007
91481407|NCT00971620|182836016|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon rank sum test|||||||0.48
91481408|NCT00971620|182836017|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon rank sum test|||||||.04
91624203|NCT01617187|183140468|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.7308|TWO_SIDED|95.0|-1.9|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.4|-1.9|0.7308
91624204|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2116|TWO_SIDED|95.0|-0.2|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.0|-0.2|0.2116
91661950|NCT04516434|183218918|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
91481409|NCT00971620|182836019|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon rank sum test|||||||.07
91624205|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9039|TWO_SIDED|95.0|-0.6|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.6|0.9039
91624206|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2959|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2959
91624207|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.5909|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5909
91661951|NCT00834522|183218925|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.79||||||90.0|99.4|108.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.37|99.40|
91661952|NCT00834522|183218926|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.37||||||90.0|97.04|112.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.25|97.04|
91481410|NCT03324581|182836047|SUPERIORITY||Difference|0.81|||=|0.7554|TWO_SIDED|95.0|-4.3|5.92||The change from baseline in CAARS-O:SV was analyzed using a Mixed-effect Model Repeated Measures (MMRM) methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||5.92|-4.30|=0.7554
91481411|NCT03324581|182836047|SUPERIORITY||Difference|-6.61|||=|0.0101|TWO_SIDED|95.0|-11.6|-1.6||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-1.60|-11.6|=0.0101
91481412|NCT03324581|182836047|SUPERIORITY||Difference|-7.42|||=|0.0033|TWO_SIDED|95.0|-12.3|-2.5||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-2.50|-12.3|=0.0033
91481413|NCT04473482|182836058|SUPERIORITY|Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios|Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|||||||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals|||
91481414|NCT04473482|182836059|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|||||||GEEs with robust sandwich estimators and Wald 95% CIs with conversion to Odds Ratios|||||
91481415|NCT00266864|182836061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|2.7|<|0.01|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in lean tissue mass across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||<0.01
91481416|NCT00266864|182836062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|101.0|STANDARD_DEVIATION|103.0||0.051|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in resting energy expenditure across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||0.051
91481417|NCT00829933|182836066|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED||||||Chi-squared|||For the incidence of bleeding events, paired comparison between the DU-176b groups was performed using the χ2 test.||||0.429
91661953|NCT00834522|183218927|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.22||||||90.0|96.9|112.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.08|96.90|
91661954|NCT00804856|183219012|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.91||||0.0523|TWO_SIDED|95.0|0.99|8.58|||Regression, Logistic||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|Analysis for Objective Response||8.58|0.99|0.0523
91661955|NCT00804856|183219016|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0208|TWO_SIDED|95.0|0.35|0.92|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||0.92|0.35|0.0208
91713789|NCT04010461|183319162|SUPERIORITY||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.097|=|0.11|TWO_SIDED|95.0|-0.037|0.355|||t-test, 2 sided|df = 35 Note: 1 subject was excluded from analysis as extraction of FPN eigenvalues failed due to technical deficiencies with image data||Analysis used standard, open-source methods for pre-processing . First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters. Statistical testing was done to establish whether more or less BOLD (neural activity) change occurred between two conditions.||0.355|-0.037|=0.11
91713790|NCT04010461|183319162|SUPERIORITY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.116||0.94|TWO_SIDED|95.0|-0.245|0.227|||t-test, 2 sided|df = 35 Note: 1 subject excluded from analysis as FPN extraction of eigenvalues failed due to technical issues with image data||Analysis used standard, open-source routes for slice timing correction, field map correction, realignment, smoothing (6 mm Gaussian kernel) and spatial normalization (MNI-152). First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters.||0.227|-0.245|0.94
91481418|NCT00829933|182836066|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Chi-squared|||||||0.077
91624208|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1489|TWO_SIDED|95.0|-1.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-1.4|0.1489
91624209|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.54||0.1|TWO_SIDED|95.0|-2.0|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-2.0|0.1000
91624210|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.783|TWO_SIDED|95.0|-0.8|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-0.8|0.7830
91624211|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2679|TWO_SIDED|95.0|-1.4|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.4|0.2679
91624212|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2321|TWO_SIDED|95.0|-1.9|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.5|-1.9|0.2321
91624213|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.7368|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.9|-1.3|0.7368
91624214|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4606|TWO_SIDED|95.0|-1.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-1.4|0.4606
91624215|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.3241|TWO_SIDED|95.0|-2.0|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.7|-2.0|0.3241
91624216|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.986|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.1|-1.1|0.9860
91722487|NCT03881371|183337729|SUPERIORITY||Least-Square Mean|1.07|STANDARD_ERROR_OF_MEAN|0.345||0.0021|TWO_SIDED|95.0|0.392|1.753||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time with no/non-troublesome Dyskinesia measurement as covariate and change from baseline as dependent variable."|ANCOVA|||||1.753|0.392|0.0021
91481419|NCT00829933|182836066|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||Wilcoxon (Mann-Whitney)|||||8.1|-11.2|
91624217|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.189|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.3|-1.8|0.1890
91481420|NCT00829933|182836066|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Chi-squared|||||||0.320
91481421|NCT00829933|182836066|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4|||||TWO_SIDED|95.0|-7.6|12.3|||Wilcoxon (Mann-Whitney)|||||12.3|-7.6|
91481422|NCT00829933|182836066|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.7|||||TWO_SIDED|95.0|-2.7|18.1|||Wilcoxon (Mann-Whitney)|||||18.1|-2.7|
91624218|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.67||0.303|TWO_SIDED|95.0|-2.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-2.0|0.3030
91624219|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.0|-2.3|0.0550
91624220|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.55||0.0415|TWO_SIDED|95.0|-2.2|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||-0.0|-2.2|0.0415
91624221|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.69||0.0058|TWO_SIDED|95.0|-3.3|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||-0.6|-3.3|0.0058
91661956|NCT00804856|183219017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0465|TWO_SIDED|95.0|0.4|1.0|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||1.00|0.40|0.0465
91661957|NCT00834132|183219046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|94.81||||||90.0|84.77|106.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.04|84.77|
91624222|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0691|TWO_SIDED|95.0|-2.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||0.1|-2.3|0.0691
91624223|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|0.58||0.0063|TWO_SIDED|95.0|-2.7|-0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.5|-2.7|0.0063
91624224|NCT01617187|183140469|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.71||0.0056|TWO_SIDED|95.0|-3.4|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.6|-3.4|0.0056
91661958|NCT00834132|183219047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.89||||||90.0|96.0|106.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.03|96.00|
91661959|NCT00834132|183219048|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.14||||||90.0|96.05|106.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.49|96.05|
91661960|NCT00835484|183219053|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.15||||||90.0|91.77|102.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.83|91.77|
91661961|NCT00835484|183219054|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.8||||||90.0|95.1|106.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.84|95.1|
91661962|NCT00835484|183219055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.39||||||90.0|95.89|107.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.2|95.89|
91661963|NCT04383587|183219062|SUPERIORITY||||||>|0.18|||||||Fisher Exact|||Participants were grouped by age (18-35 vs. 36-50 vs. 51-65 vs. \>65), Sex at birth (Female vs. Male). and Occupational Role (Technician vs Anesthesiologist vs Advanced Practice Provider vs. Attendant Aide vs. CRNA vs. OR nurse vs Perfusionist vs Surgeon).||||>0.18
91722488|NCT03881371|183337730|SUPERIORITY||Least-Square Mean|-5.99|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.842|-3.141||ANCOVA with treatment and centre as independent factors, baseline UPDRS score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-3.141|-8.842|<.0001
91791905|NCT02081248|183461555|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.26
91527731|NCT01976364|182930502|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.2|
91624225|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7847|TWO_SIDED|95.0|-0.6|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.6|0.7847
91624226|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5859|TWO_SIDED|95.0|-0.5|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.5|0.5859
91624227|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.6413|TWO_SIDED|95.0|-1.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.6|-1.0|0.6413
91624228|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7307|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7307
91624229|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7176|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7176
91624230|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.486|TWO_SIDED|95.0|-1.3|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.3|0.4860
91624231|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9321|TWO_SIDED|95.0|-0.8|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.8|-0.8|0.9321
91624232|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7691|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.7|0.7691
91661964|NCT03123094|183219065|OTHER||Slope|0.9533|STANDARD_ERROR_OF_MEAN|0.0803|||TWO_SIDED|95.0|0.781|1.1256|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter AUC0-∞, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1256|0.7810|
91661965|NCT03123094|183219066|OTHER||Slope|1.0014|STANDARD_ERROR_OF_MEAN|0.0568|||TWO_SIDED|95.0|0.8809|1.1219|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter Cmax, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1219|0.8809|
91624233|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5694|TWO_SIDED|95.0|-1.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-1.3|0.5694
91624234|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5583|TWO_SIDED|95.0|-0.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-0.6|0.5583
91624235|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.43||0.7307|TWO_SIDED|95.0|-0.7|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.0|-0.7|0.7307
91624236|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.1715|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.3|-1.8|0.1715
91624237|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.4219|TWO_SIDED|95.0|-0.6|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.5|-0.6|0.4219
91624238|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.52||0.7437|TWO_SIDED|95.0|-0.9|1.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.2|-0.9|0.7437
91624239|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.311|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-1.9|0.3110
91624240|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9805|TWO_SIDED|95.0|-1.0|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.0|-1.0|0.9805
91624241|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8741|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.8|-1.0|0.8741
91624242|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3288|TWO_SIDED|95.0|-1.7|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.6|-1.7|0.3288
91624243|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9336|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.9336
91624244|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1722|TWO_SIDED|95.0|-1.7|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-1.7|0.1722
91624245|NCT01617187|183140470|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1909|TWO_SIDED|95.0|-2.1|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.4|-2.1|0.1909
91624246|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.9851|TWO_SIDED|95.0|-0.7|0.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.7|-0.7|0.9851
91624247|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.4912|TWO_SIDED|95.0|-0.9|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.5|-0.9|0.4912
91624248|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8559|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.0|0.8559
91722489|NCT03881371|183337731|SUPERIORITY||Least-Square Mean|-1.52|STANDARD_ERROR_OF_MEAN|0.51||0.0033|TWO_SIDED|95.0|-2.521|-0.511||ANCOVA with treatment and centre as independent factors, baseline UPDRS part II (ADL) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.511|-2.521|0.0033
91624249|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.5635|TWO_SIDED|95.0|-0.6|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.1|-0.6|0.5635
91624250|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2321|TWO_SIDED|95.0|-1.3|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.2321
91624251|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.52||0.8867|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.9|-1.1|0.8867
91624252|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1499|TWO_SIDED|95.0|-0.2|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.4|-0.2|0.1499
91624253|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.286|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.2|0.2860
91624254|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8978|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.9|-1.1|0.8978
91624255|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0283|TWO_SIDED|95.0|0.1|1.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.8|0.1|0.0283
91624256|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.8667|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-0.7|0.8667
91624257|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.52||0.5044|TWO_SIDED|95.0|-0.7|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-0.7|0.5044
91624258|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.4|STANDARD_ERROR_OF_MEAN|0.49||0.004|TWO_SIDED|95.0|0.5|2.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.4|0.5|0.0040
91624259|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.46||0.633|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.1|-0.7|0.6330
91624260|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2981|TWO_SIDED|95.0|-0.5|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.7|-0.5|0.2981
91624261|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6556|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.1|-0.7|0.6556
91624262|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.2889|TWO_SIDED|95.0|-1.3|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-1.3|0.2889
91624263|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9399|TWO_SIDED|95.0|-1.1|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.0|-1.1|0.9399
91624264|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8955|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.8955
91624265|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3681|TWO_SIDED|95.0|-1.5|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.5|-1.5|0.3681
91624266|NCT01617187|183140471|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8215|TWO_SIDED|95.0|-1.4|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.1|-1.4|0.8215
91624267|NCT03337139|183140475|SUPERIORITY|||||||0.98||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week weight loss, prior to randomization.||||.98
91624268|NCT03337139|183140475|SUPERIORITY|||||||0.75||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 26 week weight loss||||.75
91624269|NCT03337139|183140475|SUPERIORITY|||||||0.02||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 52 week weight loss||||.02
91624270|NCT03337139|183140476|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week MVPA||||.12
91624271|NCT03337139|183140476|SUPERIORITY|||||||0.16||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for changes in Phase I MVPA||Comparing groups on 52 week MVPA||||.16
91624272|NCT03337139|183140477|SUPERIORITY|||||||0.43||||||A priori threshold for statistical significant was p\<.05.|Fisher Exact|||Comparing groups on 26 week retention rates||||.43
91624273|NCT03337139|183140477|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance was p\<.05.|Fisher Exact|||Comparing groups on 52 week retention rates.||||.48
91624274|NCT03337139|183140478|SUPERIORITY|||||||0.64||||||A priori threshold of statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on phone calls completed in Phase II (52 weeks)||||.64
91624275|NCT03337139|183140478|SUPERIORITY|||||||0.499||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on text messages completed in Phase II (52 weeks)||||.499
91624276|NCT03337139|183140479|SUPERIORITY|||||||0.86||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on TAQ scores at 52 weeks||||.86
91481423|NCT03687970|182836084|OTHER|Multivariable logistic regression was applied to predict binary outcome while controlling for other potential confounding factors (age, cumulative chemotherapy dose, chemotherapy group).|Slope|-0.13||||0.05|TWO_SIDED|||||threshold for p value is 0.05.|Regression, Logistic|||||||0.05
91624277|NCT03337139|183140480|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of weight during Phase II||||.002
91624278|NCT03337139|183140480|SUPERIORITY|||||||0.001||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of eating during Phase II||||.001
91791906|NCT01037088|183461557|SUPERIORITY||||||>|0.05||||||not significant|Mixed Models Analysis|||Hour 1 after Administration of Cannabis||||>.05
91624279|NCT03337139|183140480|SUPERIORITY|||||||0.25||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of physical activity during Phase II||||.25
91624280|NCT03337139|183140481|SUPERIORITY|||||||0.005||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I perceived supportive accountability||Comparing groups on changes in perceived accountability during Phase II||||.005
91624281|NCT02554253|183140482|SUPERIORITY|Pilot study||||||0.23|||||||Fisher Exact|||Raw scores converted to z-scores using published references. Percentage of patients experiencing a decline of \> 1 standard deviation was compared between groups using Fisher's exact test. The outcome of postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests and was compared between groups using Fisher's exact test.||||0.23
91624282|NCT02554253|183140483|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
91624283|NCT02554253|183140484|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
91624284|NCT02559206|183140500|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||mixed model repeated measures (MMRM)|||||0.076|-1.214|0.0839
91624285|NCT02559206|183140500|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.297||||0.3661|TWO_SIDED|95.0|-0.942|0.348|||MMRM|||||0.348|-0.942|0.3661
91624286|NCT02559206|183140500|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.286||||0.3869|TWO_SIDED|95.0|-0.936|0.363|||MMRM|||||0.363|-0.936|0.3869
91624287|NCT02559206|183140500|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.771||||0.0199|TWO_SIDED|95.0|-1.419|-0.123|||MMRM|||||-0.123|-1.419|0.0199
91624288|NCT02559206|183140500|SUPERIORITY|||||||0.0276||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0276
91624289|NCT02559206|183140501|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||MMRM|||||0.076|-1.214|0.0839
91624290|NCT02559206|183140501|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.455||||0.1669|TWO_SIDED|95.0|-1.102|0.191|||MMRM|||||0.191|-1.102|0.1669
91624291|NCT02559206|183140501|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.299||||0.3637|TWO_SIDED|95.0|-0.947|0.348|||MMRM|||||0.348|-0.947|0.3637
91624292|NCT02559206|183140501|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.258||||0.4333|TWO_SIDED|95.0|-0.905|0.389|||MMRM|||||0.389|-0.905|0.4333
91791907|NCT01037088|183461557|SUPERIORITY||||||=|0.0002|||||||Mixed Models Analysis|||Hour 2 after Administration of Cannabis||||=.0002
91722490|NCT03881371|183337732|SUPERIORITY||Least-Square Mean|-3.8|STANDARD_ERROR_OF_MEAN|0.988||0.0002|TWO_SIDED|95.0|-5.749|-1.856||ANCOVA with treatment and centre as independent factors, baseline UPDRS part III (motor function) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.856|-5.749|0.0002
91722491|NCT03881371|183337733|SUPERIORITY||Median|0.0||||0.015|TWO_SIDED|95.0|0.0|0.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-S at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||0.000|0.000|0.0150
91481424|NCT03687970|182836085|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.22||||0.7525|TWO_SIDED|||||The thrshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.7525
91481425|NCT03687970|182836085|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for Control group patients without painful CIPN was calculated.|rho coefficient|0.32||||0.1876|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficien|||||||0.1876
91481426|NCT03687970|182836085|OTHER|Spearman correlation coefficient between the Aδ:C fiber pain threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.13||||0.61|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.61
91624293|NCT02559206|183140501|SUPERIORITY|||||||0.5528||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.5528
91624294|NCT02559206|183140502|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
91624295|NCT02559206|183140502|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.048||||0.9013|TWO_SIDED|95.0|-0.716|0.812|||MMRM|||||0.812|-0.716|0.9013
91624296|NCT02559206|183140502|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.299||||0.4447|TWO_SIDED|95.0|-0.469|1.067|||MMRM|||||1.067|-0.469|0.4447
91624297|NCT02559206|183140502|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.662||||0.0904|TWO_SIDED|95.0|-0.104|1.428|||MMRM|||||1.428|-0.104|0.0904
91624298|NCT02559206|183140502|SUPERIORITY|||||||0.07||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0700
91661966|NCT04859517|183219069|SUPERIORITY||Risk Difference (RD)|-5.0||||0.0123|TWO_SIDED|95.0|-8.87|-1.08|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.08|-8.87|0.0123
91661967|NCT04859517|183219070|SUPERIORITY||Risk Difference (RD)|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.75|-2.01|||Regression, Logistic|||||-2.01|-5.75|<0.0001
91661968|NCT04859517|183219073|SUPERIORITY||Standardized Risk Difference|-7.6||||0.0153|TWO_SIDED|95.0|-13.74|-1.46|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.46|-13.74|0.0153
91661969|NCT04859517|183219074|SUPERIORITY||Risk Difference (RD)|-4.4||||0.0612|TWO_SIDED|95.0|-9.03|0.21|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|0.21|-9.03|0.0612
91481427|NCT03687970|182836085|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|-0.2812205||||0.2914|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.2914
91481428|NCT06374394|182836093|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio between the Control Group (at Day 61) versus Co-Ad Group (at Day 31) for RSV-A neutralizing titers 1-month after the RSVPreF3 OA vaccine dose was less than or equal to (≤) 1.5.|Geometric Mean Ratio (GMR)|1.12|||||TWO_SIDED|95.0|0.97|1.28|||ANCOVA|ANCOVA model included the treatment group and age category at vaccination as fixed effects and the pre-dose log10 titer as covariate.|The GMR is based on the back transformation of the group comparisons in the ANCOVA model applied to the logarithmically-transformed titers.|To demonstrate non-inferiority of humoral immune response to RSVPreF3 OA vaccine when co-administered with a COVID-19 mRNA vaccine compared to RSVPreF3 OA vaccine administered alone.||1.28|0.97|
91624299|NCT02559206|183140503|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
91624300|NCT02559206|183140503|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.161||||0.6801|TWO_SIDED|95.0|-0.604|0.925|||MMRM|||||0.925|-0.604|0.6801
91624301|NCT02559206|183140503|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.095||||0.8069|TWO_SIDED|95.0|-0.861|0.67|||MMRM|||||0.670|-0.861|0.8069
91624302|NCT02559206|183140503|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.246||||0.5275|TWO_SIDED|95.0|-1.011|0.519|||MMRM|||||0.519|-1.011|0.5275
91624303|NCT02559206|183140503|SUPERIORITY|||||||0.4201||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.4201
91624304|NCT02559206|183140504|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
91624305|NCT02559206|183140504|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4399|TWO_SIDED|95.0|0.61|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.61|0.4399
91661970|NCT04859517|183219093|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.0077|TWO_SIDED|95.0|0.06|0.76|||Log Rank|||||0.76|0.06|0.0077
91661971|NCT04859517|183219094|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.49|||Log Rank|||||0.49|0.14|<0.0001
91661972|NCT00465270|183219221|OTHER||Cox Proportional Hazard|0.49||||0.08|TWO_SIDED|95.0|0.22|1.11|||Log Rank|||||1.11|0.22|0.08
91661973|NCT00465270|183219223|OTHER||Cox Proportional Hazard|0.55||||0.046|TWO_SIDED|95.0|0.31|0.999|||Log Rank|||||0.999|0.31|0.046
91791908|NCT01037088|183461557|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)||||<.0001
91481429|NCT06374394|182836094|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control Group (at Day 61) versus Co-Ad Group (at Day 31) for RSV-B neutralizing titers 1-month after the RSVPreF3 OA vaccine dose was ≤1.5.|GMR|1.08|||||TWO_SIDED|95.0|0.94|1.23|||ANCOVA|ANCOVA model included the treatment group and age category at vaccination as fixed effects and the pre-dose log10 titer as covariate.|The GMR is based on the back transformation of the group comparisons in the ANCOVA model applied to the logarithmically-transformed titers.|To demonstrate non-inferiority of humoral immune response to RSVPreF3 OA vaccine when co-administered with a COVID-19 mRNA vaccine compared to RSVPreF3 OA vaccine administered alone.||1.23|0.94|
91624306|NCT02559206|183140504|SUPERIORITY||Odds Ratio (OR)|1.27||||0.554|TWO_SIDED|95.0|0.57|2.85|||Cochran-Mantel-Haenszel|||||2.85|0.57|0.5540
91624307|NCT02559206|183140504|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0262|TWO_SIDED|95.0|1.1|5.19|||Cochran-Mantel-Haenszel|||||5.19|1.10|0.0262
91624308|NCT02559206|183140504|SUPERIORITY|||||||0.0249||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.0249
91624309|NCT02559206|183140505|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
91624310|NCT02559206|183140505|SUPERIORITY||Odds Ratio (OR)|1.13||||0.771|TWO_SIDED|95.0|0.49|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.49|0.7710
91624311|NCT02559206|183140505|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8021|TWO_SIDED|95.0|0.48|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.48|0.8021
91624312|NCT02559206|183140505|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8011|TWO_SIDED|95.0|0.37|2.14|||Cochran-Mantel-Haenszel|||||2.14|0.37|0.8011
91624313|NCT02559206|183140505|SUPERIORITY|||||||0.8578||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.8578
91624314|NCT03127852|183140557|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 physical component summary score.||||.48
91624315|NCT03127852|183140557|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 mental component summary score.||||.73
91624316|NCT03127852|183140558|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of hospital visits.||||.02
91624317|NCT03127852|183140558|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported emergency department visits.||||.12
91624318|NCT03127852|183140558|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of clinic visits.||||.39
91624319|NCT03127852|183140558|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of family physician visits.||||.28
91624320|NCT03127852|183140559|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI maintenance sub-scale.||||.74
91624321|NCT03127852|183140559|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI management sub-scale.||||.67
91624322|NCT03127852|183140559|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI confidence sub-scale.||||.92
91624323|NCT03127852|183140560|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ total score.||||.67
91624324|NCT03127852|183140560|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ physical domain score.||||.43
91624325|NCT03127852|183140560|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ emotional domain score.||||.64
91624326|NCT03127852|183140561|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS anxiety sub-scale.||||.06
91624327|NCT03127852|183140561|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS depression sub-scale.||||.77
91624328|NCT03127852|183140562|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Poststudy between-group comparison of SEMCD6.||||.13
91624329|NCT01432457|183140579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.57||||0.006|TWO_SIDED|95.0|0.44|2.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.69|0.44|0.006
91624330|NCT01432457|183140579|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.96|||<|0.001|TWO_SIDED|95.0|0.84|3.08||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||3.08|0.84|< 0.001
91624331|NCT01432457|183140580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.36||||0.014|TWO_SIDED|95.0|0.28|2.45|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.45|0.28|0.014
91624332|NCT01432457|183140580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.67||||0.002|TWO_SIDED|95.0|0.59|2.74|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.74|0.59|0.002
91624333|NCT01432457|183140581|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||0.029
91661974|NCT01249651|183219281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
91661975|NCT01581658|183219286|SUPERIORITY_OR_OTHER||Geometric mean ratio|128.82|||||TWO_SIDED|90.0|105.962|156.604|||ANOVA|The model includes fixed effect for the renal function group||||156.604|105.962|
91661976|NCT01581658|183219286|SUPERIORITY_OR_OTHER||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|118.306|174.848|||ANOVA|The model includes fixed effect for the renal function group||||174.848|118.306|
91661977|NCT01581658|183219286|SUPERIORITY_OR_OTHER||Geometric mean ratio|152.31|||||TWO_SIDED|90.0|125.287|185.166|||ANOVA|The model includes fixed effect for the renal function group||||185.166|125.287|
91713791|NCT04010461|183319163|OTHER|Group-level analyses were performed using a General Linear Model (GLM). For each individual voxel, a separate GLM was estimated, with first-level connectivity measures at this voxel as dependent variables, and groups or other subject-level identifiers as independent variables. Voxel-level hypotheses were evaluated using multivariate parametric statistics with random effects across subjects and sample covariance estimation across multiple measurements.|random field theory|0.0||||1|TWO_SIDED|||||Inferences were performed at the level of individual clusters (groups of contiguous voxels). Cluster-level inferences were based on parametric statistics from Gaussian Random Field theory.|random field theory|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and cluster-size threshold of 25 voxels|Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs active)|The contrast reflects the difference in connectivity between the conditions/sessions, at the level of each subject, then spatially averaged across all subjects. Functional connectivity strength for the dlPFC seed was represented by Fisher-transformed bivariate correlation coefficients from a weighted general linear model (weighted-GLM), defined separately for each pair of seed and target areas, modeling the association between their BOLD signal time series.||||1
91791909|NCT01037088|183461557|SUPERIORITY||||||=|0.0004|||||||Mixed Models Analysis|||Hour 4 after Administration of Cannabis||||=.0004
91481430|NCT06374394|182836095|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control Group (at Day 31) versus Co-Ad group (at Day 31) for SARS-CoV-2 neutralizing titers 1-month after the COVID-19 mRNA vaccine dose was ≤1.5.|GMR|1.31|||||TWO_SIDED|95.0|1.13|1.51|||ANCOVA|ANCOVA model included the treatment group and age category at vaccination as fixed effects and the pre-dose log10 titer as covariate.|The GMR is based on the back transformation of the group comparisons in the ANCOVA model applied to the logarithmically-transformed titers.|To demonstrate non-inferiority of humoral immune response to a COVID-19 mRNA vaccine when co-administered with the RSVPreF3 OA vaccine compared to COVID-19 mRNA vaccine administered alone.||1.51|1.13|
91624334|NCT01432457|183140581|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||< 0.001
91624335|NCT01432457|183140582|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.009|TWO_SIDED|95.0|0.05|0.34|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|0.05|0.009
91624336|NCT01432457|183140582|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.43|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.43|0.13|< 0.001
91661978|NCT01581658|183219287|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.5|||||TWO_SIDED|90.0|72.236|121.015|||ANOVA|The model includes fixed effect for the renal function group||||121.015|72.236|
91661979|NCT01581658|183219287|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.18|||||TWO_SIDED|90.0|71.216|119.305|||ANOVA|The model includes fixed effect for the renal function group||||119.305|71.216|
91791910|NCT01037088|183461557|SUPERIORITY||||||=|0.0018|||||||Mixed Models Analysis|||Hour 5 after Administration of Cannabis||||=.0018
91525095|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.219|=|0.003|TWO_SIDED|95.0|-1.05|-0.18||1-sided p-value was reported.|MMRM|||Muscle Spasms|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.18|-1.05|=0.003
91661980|NCT01581658|183219287|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.01|||||TWO_SIDED|90.0|72.63|121.674|||ANOVA|The model includes fixed effect for the renal function group||||121.674|72.630|
91661981|NCT00199901|183219357|SUPERIORITY||Hazard Ratio (HR)|0.913|||||TWO_SIDED|95.0|0.532|1.568||||||||1.568|0.532|
91661982|NCT00199901|183219359|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.532|1.455||||||||1.455|0.532|
91661983|NCT00199901|183219360|SUPERIORITY||Hazard Ratio (HR)|0.911|||||TWO_SIDED|95.0|0.514|1.614||||||||1.614|0.514|
91661984|NCT05776901|183219368|OTHER|Descriptive statistics and measures of central tendency, including mean, median, and standard deviation of the System Usability Scores collected from the baseline and week 3 were computed. Then, a two-sided, paired sample t-test was conducted to evaluate the change in mean System Usability Scores from baseline at week 3.|Mean diff in SUS from baseline at week 3|34.17|STANDARD_ERROR_OF_MEAN|14.49|<|0.05|TWO_SIDED|95.0|-28.04|96.37|||t-test, 2 sided|||||96.37|-28.04|<0.05
91661985|NCT04517604|183219373|SUPERIORITY||Mean Difference (Final Values)|-5.02|STANDARD_DEVIATION|4.984||0.343|TWO_SIDED|95.0|-16.52|6.47||no adjustment for multiple comparisons as was a pilot|Mixed Models Analysis|||||6.47|-16.52|.343
91661986|NCT04517604|183219374|SUPERIORITY|This was a pilot study funded under a pilot funding mechanism which specifically did not require a power analysis.|Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|0.42||0.0026|TWO_SIDED|95.0|-2.63|-0.77||no test for multiple comparisons as this was a pilot study|Mixed Models Analysis|||This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.||-.77|-2.63|.0026
91661987|NCT04523168|183219419|SUPERIORITY|||||||0.0137|||||||Wilcoxon (Mann-Whitney)|||Baseline, 120 days||||0.0137
91661988|NCT04523168|183219421|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91481431|NCT01966692|182836147|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|106.0||||0.4132|TWO_SIDED|90.0|99.0|114.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||114|99|0.4132
91481432|NCT01966692|182836147|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|109.0||||0.1295|TWO_SIDED|90.0|102.0|116.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||116|102|0.1295
91481433|NCT01966692|182836147|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|114.0||||0.0078|TWO_SIDED|90.0|106.0|122.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||122|106|0.0078
91481434|NCT01966692|182836148|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|182.0|||<|0.001|TWO_SIDED|90.0|159.0|208.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||208|159|<0.001
91481435|NCT01966692|182836148|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|190.0|||<|0.001|TWO_SIDED|90.0|166.0|217.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||217|166|<0.001
91481436|NCT01966692|182836148|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|213.0|||<|0.001|TWO_SIDED|90.0|186.0|244.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||244|186|<0.001
91481437|NCT00509392|182836196|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91481438|NCT00509392|182836197|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91624337|NCT01432457|183140583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17||||0.062|TWO_SIDED|95.0|-0.01|0.34|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|-0.01|0.062
91624338|NCT01432457|183140583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.22||||0.014|TWO_SIDED|95.0|0.04|0.39|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.39|0.04|0.014
91624339|NCT01432457|183140584|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.242||||0.198|TWO_SIDED|95.0|0.893|1.726|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.726|0.893|0.198
91624340|NCT01432457|183140584|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.378||||0.054|TWO_SIDED|95.0|0.995|1.91|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.910|0.995|0.054
91661989|NCT00075478|183219456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||Reference arm is Arm 2.||1.1|0.3|.09
91661990|NCT00075478|183219457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.59|TWO_SIDED|95.0|0.1|3.0|||Regression, Cox|||||3.0|0.1|0.59
91661991|NCT00075478|183219458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.06|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.06
91661992|NCT00075478|183219459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||||1.1|0.3|0.09
91661993|NCT00075478|183219460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.16|TWO_SIDED|95.0|0.8|3.1|||Regression, Cox|||||3.1|0.8|0.16
91481439|NCT00509392|182836198|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91624341|NCT01432457|183140585|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.105||||0.615|TWO_SIDED|95.0|0.749|1.631|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.631|0.749|0.615
91624342|NCT01432457|183140585|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.412||||0.072|TWO_SIDED|95.0|0.969|2.057|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.057|0.969|0.072
91624343|NCT01432457|183140586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09||||0.837|TWO_SIDED|95.0|-0.98|0.8||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.80|-0.98|0.837
91624344|NCT01432457|183140586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32||||0.471|TWO_SIDED|95.0|-1.19|0.55||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.55|-1.19|0.471
91624345|NCT01090102|183140595|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|t-test, 2 sided|||||||0.63
91624346|NCT01090102|183140596|SUPERIORITY_OR_OTHER|||||||0.77||||||significant at p\<0.05|t-test, 2 sided|||||||0.77
91624347|NCT03518034|183140602|NON_INFERIORITY|Noninferiority margin in terms of HR is 1.5.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.17|||||HR of AndroGel to placebo and 95% CI were estimated from Cox proportional-hazards regression model, with adjustment for pre-existing CVD.|The hazard ratio (HR) and 2-sided 95% confidence interval (CI) were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing cardiovascular disease (CVD) status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of MACE. If a subject does not experience a MACE during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.17|0.78|
91624348|NCT03518034|183140604|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.86|1.21|||||HR of AndroGel to placebo and 2-sided 95% CI were estimated from a Cox proportional-hazards regression model with adjustment of pre-existing CVD status.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of CV safety endpoint. If a participant does not experience a CV safety endpoint during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.21|0.86|
91624349|NCT03518034|183140605|SUPERIORITY||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.39|6.77|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior cardiovascular disease (CVD).|The high grade prostate cancer endpoint was analyzed using a discrete time proportional hazard regression model with event time intervals based on scheduled visits, and adjusting for pre-existing CVD status. The HR of AndroGel to Placebo and its 2-sided 95% CI were provided.||6.77|0.39|
91624350|NCT03518034|183140606|SUPERIORITY|||||||0.011||||||P-value is derived from the omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using linear mixed regression model.|linear mixed regression model|Omnibus likelihood-ratio chi-square test from linear mixed regression model||A linear mixed regression model was used to analyze the change in PDQ-Q4 from baseline to months 6, 12, and 24, with the dependent variable being the change in PDQ-Q4 score. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CVD status. An unstructured covariance matrix was used to account for correlations among repeated measures within-subject.||||0.011
91661994|NCT00075478|183219461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.52||||0.14|TWO_SIDED|95.0|0.9|2.7|||Regression, Cox|||||2.7|0.9|0.14
91661995|NCT00075478|183219463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.05|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.05
91481440|NCT00509392|182836199|SUPERIORITY_OR_OTHER|||||||0.2962||95.0|||||t-test, 2 sided|||||||0.2962
91481441|NCT00509392|182836200|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||t-test, 2 sided|||||||0.0048
91481442|NCT00509392|182836201|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||t-test, 2 sided|||||||0.0036
91481443|NCT00509392|182836202|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
91481444|NCT00509392|182836203|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||t-test, 2 sided|||||||0.5761
91481445|NCT00509392|182836204|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91481446|NCT00509392|182836205|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91661996|NCT00824291|183219486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.12||||0.002|TWO_SIDED|95.0|0.78|3.46|||ANCOVA|||||3.46|0.78|0.002
91661997|NCT00824291|183219487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.33||||0.067|TWO_SIDED|95.0|-0.09|2.76|||ANCOVA|||||2.76|-0.09|0.067
91661998|NCT00824291|183219488|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91661999|NCT00824291|183219489|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
91662000|NCT00824291|183219490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.04|TWO_SIDED|95.0|0.01|0.44|||ANCOVA|||||0.44|0.01|0.040
91662001|NCT00824291|183219491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26||||0.035|TWO_SIDED|95.0|0.16|4.37|||ANCOVA|||||4.37|0.16|0.035
91662002|NCT00824291|183219492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.041|TWO_SIDED|95.0|0.1|4.78|||ANCOVA|||||4.78|0.10|0.041
91662003|NCT00824291|183219493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.145|TWO_SIDED|95.0|-0.13|0.91|||ANCOVA|||||0.91|-0.13|0.145
91481447|NCT00509392|182836206|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91662004|NCT02115347|183219495|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.31|||||TWO_SIDED|90.0|68.01|112.08|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.08|68.01|
91662005|NCT02115347|183219496|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.43|||||TWO_SIDED|90.0|68.11|112.22|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.22|68.11|
91662006|NCT02115347|183219497|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.81|||||TWO_SIDED|90.0|72.4|126.79|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.79|72.40|
91662007|NCT02115347|183219498|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.92|||||TWO_SIDED|90.0|72.46|126.97|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.97|72.46|
91662008|NCT02115347|183219499|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|78.7|||||TWO_SIDED|90.0|65.74|94.23|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||94.23|65.74|
91662009|NCT02115347|183219500|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|86.52|||||TWO_SIDED|90.0|70.49|106.2|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||106.20|70.49|
91662010|NCT02849457|183219511|SUPERIORITY||Mean Difference (Final Values)|-0.6565|STANDARD_ERROR_OF_MEAN|3.9332||0.8681|TWO_SIDED|95.0|-8.5567|7.2436|||Mixed Models Analysis|Adjusted for age (\<=7 vs \>7 months) at randomization and sex. Unstructured covariance used among 12 and 24 month outcomes.|Parameter represents estimated amount difference in group means. Negative value represents higher mean in placebo group.|||7.2436|-8.5567|0.8681
91662011|NCT02849457|183219512|SUPERIORITY|||||||0.7375|||||||Chi-squared|||||||0.7375
91662012|NCT02849457|183219513|SUPERIORITY||Hazard Ratio (HR)|0.593||||0.1174|TWO_SIDED|95.0|0.309|1.14|||Regression, Cox|Adjusted for age (\<=7 vs \>7 months) at randomization and sex.||||1.140|0.309|0.1174
91662013|NCT02849457|183219514|OTHER|Two-sided test of non-equivalence||||||0.4653|||||||Chi-squared|||||||0.4653
91662014|NCT02849457|183219515|SUPERIORITY||Mean Difference (Final Values)|-4.4392|STANDARD_ERROR_OF_MEAN|3.1889||0.1697|TWO_SIDED|95.0|-10.8346|1.9562|||Mixed Models Analysis|Adjusted for age at randomization (\<=7 vs \>7 months) and sex. Unstructured covariance used among 12, 24, and 36 month outcomes.|Pertains to the estimated difference in mean score between groups at study visit corresponding to 24 months of age.|||1.9562|-10.8346|0.1697
91662015|NCT01068821|183219525|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student's T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher's Exact test.||||0.1
91481448|NCT00509392|182836207|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.0050
91481449|NCT00509392|182836209|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 2 sided|||||||0.0009
91481450|NCT00509392|182836210|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
91662016|NCT01068821|183219526|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||Fischer's exact test, significance defined as p\<0.05||||0.5
91662017|NCT02558491|183219538|OTHER|||||||0.045||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.045
91662018|NCT02558491|183219538|OTHER|||||||0.07||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.07
91662019|NCT02558491|183219538|OTHER|||||||0.177||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.177
91662020|NCT02558491|183219539|OTHER|||||||0.042||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test was used. Data were first binned (to ensure minimum count of five per bins) \& w2 statistics was used with expected counts given by standard of care. Based on achieved recruitment, moderate effect size (0.3) was detectable with 80% power, or large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.042
91713792|NCT04010461|183319163|OTHER|The applied test with random field theory uses a metric of spatial dispersion, testing against the null hypothesis that spatial clusters of difference across the analyzed region are no different from chance clustering.|random field theory|0.0||||1|TWO_SIDED||||||random field theory||Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs control)|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and a corrected false discovery rate (FDR) p \< 0.05 cluster-size threshold.||||1
91624351|NCT03518034|183140606|SUPERIORITY||LS Mean of Difference|0.49|||||TWO_SIDED|95.0|0.19|0.79|||||LS mean difference (AndroGel - Placebo) at month 6 was derived from linear mixed regression model.|Month 6 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.79|0.19|
91624352|NCT03518034|183140606|SUPERIORITY||LS Mean of Difference|0.47|||||TWO_SIDED|95.0|0.11|0.83|||||LS mean difference (AndroGel - Placebo) at month 12 was derived from linear mixed regression model.|Month 12 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.83|0.11|
91624353|NCT03518034|183140606|SUPERIORITY||LS Mean of Difference|0.48|||||TWO_SIDED|95.0|-0.01|0.96|||||LS mean difference (AndroGel - Placebo) at month 24 was derived from linear mixed regression model.|Month 24 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.96|-0.01|
91624354|NCT03518034|183140607|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.96|3.86||||||Month 6 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.86|0.96|
91624355|NCT03518034|183140607|SUPERIORITY||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.64|3.63||||||Month 12 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.63|0.64|
91624356|NCT03518034|183140607|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.42|1.94||||||Month 24 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||1.94|0.42|
91624357|NCT03518034|183140607|SUPERIORITY|||||||0.197||||||The omnibus test p value is a test of the null hypothesis of no difference between AndroGel and placebo groups across all time points.|GEE Poisson regression model|||Risk ratio of remission of LG-PDD in the TRT versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||||0.197
91624358|NCT03518034|183140609|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.04|1.97|||||Cox proportional-hazards model.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a subject is defined as the time from randomization to the first occurrence of a clinical fracture. If a subject does not experience a clinic fracture during the study, the follow-up time is right-censored at the time of subject's last available follow-up observation.||1.97|1.04|
91624359|NCT03518034|183140610|OTHER|||||||0.002||||||p-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|omnibus likelihood-ratio chi-square test|||Repeated measures log-binomial regression with effects for treatment, visit, treatment-by-visit interaction, and adjusted for pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.002
91624360|NCT03518034|183140611|SUPERIORITY|||||||0.494||||||P-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|Repeated measures log-binomial regr.|||The risk ratio of progression to diabetes in the AndroGel versus placebo group was estimated by a repeated measures log-binomial regression with fixed effects for treatment, visit, treatment-visit interaction, and pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.494
91624361|NCT03518034|183140612|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Cox proportional-hazards model adjusting for prior CVD.|||1.23|0.78|
91624362|NCT03518034|183140613|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62|||||Cox proportional-hazards model adjusting for prior CVD.|||1.62|0.76|
91624363|NCT03518034|183140614|SUPERIORITY||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.92|2.32|||||Cox proportional-hazards model adjusting for prior CVD.|||2.32|0.92|
91624364|NCT03518034|183140615|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.51|||||Cox proportional-hazards model adjusting for prior CVD.|||1.51|0.56|
91624365|NCT03518034|183140616|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.55|2.31|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.31|0.55|
91624366|NCT03518034|183140617|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.47|2.42|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.42|0.47|
91624367|NCT03518034|183140618|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.65|2.41|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.41|0.65|
91624368|NCT03518034|183140619|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.87|1.54|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||1.54|0.87|
91624369|NCT03518034|183140620|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|0.95|3.84|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||3.84|0.95|
91713793|NCT04010461|183319164|SUPERIORITY||F-ratio|0.1||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
91481451|NCT00509392|182836211|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
91481452|NCT00509392|182836212|SUPERIORITY_OR_OTHER|||||||0.2825||95.0|||||t-test, 2 sided|||||||0.2825
91481453|NCT00509392|182836213|SUPERIORITY_OR_OTHER|||||||0.0854||95.0|||||t-test, 2 sided|||||||0.0854
91481454|NCT00509392|182836214|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||t-test, 2 sided|||||||0.0044
91481455|NCT00509392|182836215|SUPERIORITY_OR_OTHER|||||||0.0457||95.0|||||t-test, 2 sided|||||||0.0457
91481456|NCT00509392|182836216|SUPERIORITY_OR_OTHER|||||||0.9463||95.0|||||t-test, 2 sided|||||||0.9463
91624370|NCT02007252|183140663|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1037|||||||ANCOVA|||Month 3||||= 0.1037
91624371|NCT02007252|183140663|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.4806|||||||ANCOVA|||Month 12||||= 0.4806
91624372|NCT03325556|183140666|SUPERIORITY||Hazard Ratio (HR)|0.353|STANDARD_ERROR_OF_MEAN|0.3676||0.0023|TWO_SIDED|95.0|0.172|0.727||1-sided p-value reported. The protocol-defined O'Brien Flemming stopping boundary for the planned IA was a 1-sided p-value equal to 0.0033|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.727|0.172|0.0023
91624373|NCT03325556|183140667|SUPERIORITY||Hazard Ratio (HR)|0.452|STANDARD_ERROR_OF_MEAN|0.2812||0.0024|TWO_SIDED|95.0|0.261|0.785||1-sided p-value|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.785|0.261|0.0024
91624374|NCT00762268|183140674|SUPERIORITY_OR_OTHER|||||||1|||||||Regression, Linear|||||||1.0
91624375|NCT00762268|183140675|OTHER|||||||0.05|||||||Chi-squared|||Change from intake scores.||||0.05
91624376|NCT00762268|183140676|OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
91624377|NCT05034614|183140682|SUPERIORITY|||||||0.75|||||||Chi-squared|||||||.75
91624378|NCT03892707|183140688|SUPERIORITY|The between-group comparison on primary endpoint - change from baseline in pain intensity as measured on 0-10 points NRS scale at 10 days after the start of treatment was performed using analysis of covariance (ANCOVA). The difference between pain intensity at 10 days after the start of treatment and baseline (V3-V1) as response variable, treatment group as fixed factor and baseline pain intensity as a covariate was included into the model.|||||<|0.001|||||||ANCOVA|||"Since the superiority of one treatment over the other is investigated and taking into consideration that smaller negative values of the primary variable correspond to the greater reduction of pain, the statistical hypotheses are:~Null hypothesis (H0):~H0: μ2 - μ1 ≥ 0~Alternative hypothesis (HA):~HA: μ2 - μ1 \< 0, where μ1 и μ2 are the mean changes from baseline in pain intensity for (1) modern NSAIDs therapy and for (2) modern NSAIDs + Milgamma\\ Milgamma compositum therapy, correspondingly."||||<0.001
91624379|NCT03892707|183140689|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes from baseline in pain intensity measured on 0-10 points NRS scale at 5, 24 and 38 days after were compared between groups using ANCOVA models similar to those used for the analysis of the primary variable.||||<0.001
91624380|NCT03892707|183140690|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91624381|NCT03892707|183140691|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 2 (5 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 2)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
91624382|NCT03892707|183140691|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 3 (10 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 3)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
91624383|NCT03892707|183140691|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.||||||0.061|||||||Regression, Logistic|||For Visit 4 (24 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 4)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||0.061
91624384|NCT03892707|183140692|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Change from baseline in pain-related disability as measured by Roland Morris disability questionnaire at 10 days after the start of treatment was compared between groups using analysis of covariance (ANCOVA) model with treatment group as fixed factor and baseline value disability score as a covariate.||||<0.001
91624385|NCT03892707|183140693|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Episode of pain flare-up was defined as presence of at least 1 day with pain following a period without pain lasting at least 4 weeks . The denominator for the proportion was the number of FAS patients who had at least one pain-free period with approximately 4 weeks duration registered during the study.||||<0.001
91624386|NCT03892707|183140694|SUPERIORITY||Difference in proportion|28.6|||||TWO_SIDED|95.0|-3.6|60.7||||||Difference in proportion of patients with at least one pain flare-up resulting in consultancy with physician||60.7|-3.6|
91624387|NCT03892707|183140694|SUPERIORITY||Difference in proportion|-17.1|||||TWO_SIDED|95.0|-51.6|17.4||||||Difference in proportion of patients with at least one pain flare-up resulting in disruption of daily activity||17.4|-51.6|
91624388|NCT03892707|183140694|SUPERIORITY||Difference in proportion|25.7|||||TWO_SIDED|95.0|-4.1|55.5||||||Difference in proportion of patients with at least one pain flare-up resulting in NSAIDs intake||55.5|-4.1|
91624389|NCT03892707|183140695|SUPERIORITY|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||NSAIDs intake during the study was analyzed. In order to calculate the total number of treatment days with NSAIDs, first, intersecting or adjacent records were collapsed, irrespective of the specific drug used; the duration of each of the resulting intake periods was determined as (End date - Start date + 1) and, finally, all individual duration values were summed up. In case medication intake was ongoing at the end of study, end date was imputed by the date of study completion.||||0.986
91481457|NCT03954041|182836217|SUPERIORITY||LS mean difference|4.62|||=|0.3752|TWO_SIDED|95.0|-5.74|14.98||P-value was analyzed by ANCOVA model with covariates: treatment, interactive response technology (IRT) stratification factors at randomization, baseline total contusion volume based on central read, imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||14.98|-5.74|= 0.3752
91624390|NCT03892707|183140698|SUPERIORITY|||||||0.921|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 5 days since the start of study treatment.||||0.921
91624391|NCT03892707|183140698|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 10 days since the start of study treatment||||0.051
91624392|NCT03892707|183140698|SUPERIORITY|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 38 days since the start of study treatment||||0.651
91624393|NCT03892707|183140698|SUPERIORITY|||||||0.106|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 3 months since the start of study treatment||||0.106
91624394|NCT01807949|183140719|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.62||||0.0004|TWO_SIDED|95.0|1.18|4.06|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than \[\<\] 18 versus greater than equal to \[\>=\]18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.06|1.18|0.0004
91624395|NCT01807949|183140719|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.56|4.44|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.44|1.56|<0.0001
91624396|NCT01807949|183140720|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42||||0.0007|TWO_SIDED|95.0|1.86|6.98|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||6.98|1.86|0.0007
91624397|NCT01807949|183140720|SUPERIORITY_OR_OTHER||LS Mean Difference|5.25|||<|0.0001|TWO_SIDED|95.0|2.69|7.81|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||7.81|2.69|<0.0001
91624398|NCT01807949|183140721|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.0001|TWO_SIDED|95.0|0.23|0.59|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.59|0.23|<0.0001
91624399|NCT01807949|183140721|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.0001|TWO_SIDED|95.0|0.17|0.54|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.54|0.17|0.0001
91624400|NCT01807949|183140722|SUPERIORITY_OR_OTHER||LS Mean Difference|2.21||||0.1651|TWO_SIDED|95.0|-0.91|5.33|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||5.33|-0.91|0.1651
91624401|NCT01807949|183140722|SUPERIORITY_OR_OTHER||LS Mean Difference|2.85||||0.0736|TWO_SIDED|95.0|-0.27|5.98|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||5.98|-0.27|0.0736
91624402|NCT01807949|183140723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9568|||<|0.0001|TWO_SIDED|95.0|1.8829|4.6431||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.6431|1.8829|<0.0001
91624403|NCT01807949|183140723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3834||||0.0001|TWO_SIDED|95.0|1.5234|3.7286||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.7286|1.5234|0.0001
91624404|NCT01807949|183140724|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6912||||0.0116|TWO_SIDED|95.0|0.5187|0.9209||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9209|0.5187|0.0116
91624405|NCT01807949|183140724|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.5659||||0.0002|TWO_SIDED|95.0|0.4191|0.7641||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.7641|0.4191|0.0002
91713794|NCT04010461|183319165|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
91481458|NCT03954041|182836218|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.4|3.36||||||Statistical analysis of combined BIIB093 vs placebo||3.36|0.40|
91481459|NCT03954041|182836219|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.4306|TWO_SIDED|95.0|0.56|3.86||P-value was analyzed by ordinal logistic regression on mRS adjusting for covariates: treatment, IRT stratification factors at randomization, baseline mRS score, and baseline total contusion volume based on central read.|Regression, Logistic|||Statistical analysis of combined BIIB093 vs placebo||3.86|0.56|=0.4306
91481460|NCT03954041|182836221|SUPERIORITY||LS Mean difference|-1.53|||=|0.6478|TWO_SIDED|95.0|-8.19|5.13||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline total contusion volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||5.13|-8.19|= 0.6478
91713795|NCT04010461|183319165|SUPERIORITY|||||||0.65|||||||ANOVA|||||||.65
91722492|NCT03881371|183337734|SUPERIORITY||Median|0.5||||0.0007|TWO_SIDED|95.0|0.0|1.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-C score at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||1.000|0.000|0.0007
91481461|NCT03954041|182836222|SUPERIORITY||LS Mean Difference|-0.09|||=|0.9314|TWO_SIDED|95.0|-2.2|2.02||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline Glasgow Coma Scale (GCS) based on eCRF, and baseline absolute hematoma volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||2.02|-2.20|=0.9314
91624406|NCT01807949|183140725|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13|||<|0.0001|TWO_SIDED|95.0|0.62|1.64|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||1.64|0.62|<0.0001
91624407|NCT01807949|183140725|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95||||0.0003|TWO_SIDED|95.0|0.43|1.46|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||1.46|0.43|0.0003
91624408|NCT01807949|183140726|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2313||||0.0005|TWO_SIDED|95.0|0.1037|0.3589|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.3589|0.1037|0.0005
91624409|NCT01807949|183140726|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2217||||0.0006|TWO_SIDED|95.0|0.0961|0.3473|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.3473|0.0961|0.0006
91624410|NCT01807949|183140727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0384|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0384
91624411|NCT01807949|183140727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.533||||0.0003|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0003
91624412|NCT01807949|183140728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6373||||0.0393|TWO_SIDED|95.0|0.416|0.9764|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||0.9764|0.4160|0.0393
91624413|NCT01807949|183140728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4429||||0.0002|TWO_SIDED|95.0|0.2863|0.6851|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||0.6851|0.2863|0.0002
91624414|NCT01807949|183140729|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0028||||0.7679|TWO_SIDED|95.0|-0.0211|0.0156|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0156|-0.0211|0.7679
91624415|NCT01807949|183140729|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0009||||0.9214|TWO_SIDED|95.0|-0.0192|0.0174|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0174|-0.0192|0.9214
91624416|NCT01807949|183140730|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1034|TWO_SIDED|95.0|-0.5|5.3|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||5.3|-0.5|0.1034
91624417|NCT01807949|183140730|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0262|TWO_SIDED|95.0|0.4|6.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||6.2|0.4|0.0262
91624418|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|8.64||||0.0005|TWO_SIDED|95.0|3.77|13.51|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||13.51|3.77|0.0005
91624419|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|11.61|||<|0.0001|TWO_SIDED|95.0|6.75|16.48|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||16.48|6.75|<0.0001
91624420|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.0403|TWO_SIDED|95.0|-6.21|-0.14|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-0.14|-6.21|0.0403
91662021|NCT02558491|183219539|OTHER|||||||0.276||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.276
91624421|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29||||0.0054|TWO_SIDED|95.0|-7.31|-1.28|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.28|-7.31|0.0054
91624422|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||1|TWO_SIDED|95.0|-4.07|4.07|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.07|-4.07|1.0000
91624423|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.8777|TWO_SIDED|95.0|-3.74|4.37|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||4.37|-3.74|0.8777
91722493|NCT03881371|183337735|SUPERIORITY||Least-Square Mean|-3.36|STANDARD_ERROR_OF_MEAN|1.132||0.0033|TWO_SIDED|95.0|-5.589|-1.128||ANCOVA with treatment and centre as independent factor, baseline Summary Index score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.128|-5.589|0.0033
91624424|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|4.64||||0.0668|TWO_SIDED|95.0|-0.32|9.61|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||9.61|-0.32|0.0668
91624425|NCT01807949|183140731|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.0045|TWO_SIDED|95.0|2.23|12.08|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||12.08|2.23|0.0045
91624426|NCT00881361|183140805|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91624427|NCT02141217|183140809|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|1.5|||||TWO_SIDED|95.0|-4.9|8.0||||||||8.0|-4.9|
91624428|NCT02141217|183140810|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|0.9|||||TWO_SIDED|95.0|-5.6|7.4||||||||7.4|-5.6|
91624429|NCT02141217|183140811|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|2.3|||||TWO_SIDED|95.0|-4.4|9.0||||||||9.0|-4.4|
91624430|NCT01628393|183140826|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
91624431|NCT01628393|183140826|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
91624432|NCT01628393|183140827|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
91624433|NCT01628393|183140827|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
91624434|NCT01628393|183140828|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
91624435|NCT01628393|183140828|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
91624436|NCT01628393|183140829|SUPERIORITY||Rate Ratio|0.47||||0.0531|TWO_SIDED|95.0|0.22|1.01|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.01|0.22|0.0531
91662022|NCT02558491|183219540|OTHER|||||||0.026||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.026
91481462|NCT03954041|182836223|SUPERIORITY||LS Mean difference|2.18|||=|0.6569|TWO_SIDED|95.0|-7.61|11.98||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline absolute edema volume based on central read, baseline GCS based on eCRF, and imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||11.98|-7.61|= 0.6569
91624437|NCT01628393|183140829|SUPERIORITY||Rate Ratio|0.69||||0.2714|TWO_SIDED|95.0|0.36|1.34|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.34|0.36|0.2714
91624438|NCT01226706|183140834|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||"A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.~Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics."||||.016
91624439|NCT01226706|183140835|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.152
91624440|NCT01226706|183140836|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
91624441|NCT01226706|183140837|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.067
91624442|NCT01226706|183140841|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
91624443|NCT01226706|183140842|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
91624444|NCT01226706|183140843|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
91624445|NCT01226706|183140847|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.904
91624446|NCT01226706|183140848|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.080
91481463|NCT01896479|182836225|NON_INFERIORITY|The non-inferiority margin used was 1.58.|Cox Proportional Hazard|1.24||||0.1916|TWO_SIDED|95.0|0.9|1.7||Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).|Log Rank|||||1.70|0.90|0.1916
91624447|NCT01226706|183140849|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
91624448|NCT01226706|183140853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.021|TWO_SIDED|95.0|-2.1|-0.2|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.2|-2.1|0.021
91624449|NCT01226706|183140854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.007|TWO_SIDED|95.0|-2.1|-0.5|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.5|-2.1|0.007
91624450|NCT01226706|183140855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.013|TWO_SIDED|95.0|-2.0|-0.4|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.4|-2.0|0.013
91624451|NCT01226706|183140856|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.173
91624452|NCT01226706|183140857|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
91624453|NCT01226706|183140858|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
91624454|NCT01226706|183140859|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.557
91624455|NCT01226706|183140860|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.029
91624456|NCT01226706|183140861|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
91624457|NCT01226706|183140862|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.085
91624458|NCT01226706|183140863|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.099
91624459|NCT01226706|183140864|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
91624460|NCT01226706|183140865|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.072
91624461|NCT01226706|183140866|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
91624462|NCT01226706|183140867|SUPERIORITY_OR_OTHER|||||||0.314|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.314
91624463|NCT01226706|183140868|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.013
91624464|NCT01226706|183140869|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.888
91624465|NCT04015440|183140873|OTHER|Linear Regression|||||<|0.001|||||||Regression, Linear|||||||<.001
91624466|NCT04015440|183140874|OTHER|Regression||||||0.027|||||||Regression, Linear|||||||.027
91624467|NCT04015440|183140875|OTHER|Logistic Regression||||||0.004|||||||Regression, Logistic|||||||.004
91624468|NCT01899677|183140884|SUPERIORITY_OR_OTHER|||||||0.32|||||||Mann whitney U|||Mann Whitney U test was used to compare cytokine levels between groups.||||0.32
91624469|NCT01899677|183140885|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mann whitney U|||||||0.73
91624470|NCT01899677|183140886|SUPERIORITY_OR_OTHER|||||||0.66|||||||Mann whitney U|||||||0.66
91624471|NCT01899677|183140887|SUPERIORITY_OR_OTHER|||||||0.76|||||||Mann whitney U|||||||0.76
91624472|NCT02151682|183140898|NON_INFERIORITY|A logistic regression model was fitted to the response using baseline pain, age group, treatment, and underlying pain condition as explanatory variables, followed by a Farrington-Manning test for non-inferiority, based on Full Analysis Set.|Risk Difference (RD)|-0.06||||0.079|TWO_SIDED|80.0|-0.19|0.06||The p-value is based on Farrington-Manning variance estimator using a pre-specified non-inferiority margin of -0.2. A 1-sided alpha of 0.1 was used. A p-value \<0.1 represents non-inferiority.|Farrington-Manning test|Non-inferiority of tapentadol prolonged-release versus morphine prolonged-release has been demonstrated.|A confidence interval for the risk difference (RD) completely above the pre-specified non-inferiority margin of -0.2 represents non-inferiority of tapentadol prolonged-release versus morphine prolonged-release.|||0.06|-0.19|0.0790
91624473|NCT02988219|183140917|SUPERIORITY_OR_OTHER|||||||0.3861|||||||Chi-squared|||Bradycardia during surgery||||0.3861
91624474|NCT02988219|183140917|SUPERIORITY_OR_OTHER|||||||0.2591|||||||Chi-squared|||No bradycardia observed in the perioperative period||||0.2591
91624475|NCT02988219|183140918|SUPERIORITY_OR_OTHER|||||||0.597|||||||Chi-squared|||Arrhythmia before surgery||||0.597
91624476|NCT02988219|183140918|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||arrhythmia during surgery||||0.4
91624477|NCT02988219|183140918|SUPERIORITY_OR_OTHER|||||||0.6544|||||||Chi-squared|||arrhythmia after surgery||||0.6544
91722494|NCT04225832|183337785|SUPERIORITY||Odds Ratio (OR)|2.51||||0.049|TWO_SIDED|95.0|1.01|6.26||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm||Regression results control for immigration status and length of time in U.S.|6.26|1.01|.049
91481464|NCT01896479|182836226|OTHER|Descriptive statistical analysis.|Odds Ratio (OR)|1.0195||||0.9437|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).||||1.7|0.6|0.9437
91624478|NCT02988219|183140918|SUPERIORITY_OR_OTHER|||||||0.077|||||||Chi-squared|||long QTc \> 0.45s after surgery||||0.077
91624479|NCT02988219|183140918|SUPERIORITY_OR_OTHER|||||||0.0174|||||||Chi-squared|||long QTc \> 0.24 s in the perioperative time||||0.0174
91624480|NCT01306032|183140920|SUPERIORITY_OR_OTHER|||||||0.034|||||||Log Rank|||||||0.034
91662023|NCT02558491|183219540|OTHER|||||||0.173||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.173
91662024|NCT02558491|183219540|OTHER|||||||0.715||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.715
91662025|NCT02558491|183219541|OTHER|||||||0.036||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.036
91662026|NCT02558491|183219541|OTHER|||||||0.213||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.213
91662027|NCT02558491|183219541|OTHER|||||||0.11||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.110
91481465|NCT02325791|182836284|SUPERIORITY||percentage treatment difference|1.15||||0.5773|TWO_SIDED|95.0|-2.898|5.201|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||5.201|-2.898|0.5773
91662028|NCT02558491|183219542|OTHER|||||||0.018||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.018
91662029|NCT02558491|183219542|OTHER|||||||0.149||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.149
91662030|NCT02558491|183219542|OTHER|||||||0.109||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.109
91722495|NCT04225832|183337786|SUPERIORITY||Odds Ratio (OR)|1.06||||0.83|TWO_SIDED|95.0|0.62|1.81||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm|||1.81|0.62|.83
91489385|NCT02484690|182851571|SUPERIORITY||Difference in Least Squares Means|-0.52||||0.9581|TWO_SIDED|80.0|-13.26|12.22||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||12.22|-13.26|0.9581
91624481|NCT01306032|183140920|SUPERIORITY_OR_OTHER|||||||0.68|||||||Log Rank|||||||0.68
91624482|NCT01522443|183140933|SUPERIORITY_OR_OTHER|||||||0.773|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||0.773
91624483|NCT01522443|183140934|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||<0.001
91624484|NCT01522443|183140935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.121|TWO_SIDED|95.0|0.44|1.1|||Log Rank|The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||1.10|0.44|0.121
91624485|NCT01700985|183140980|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91624486|NCT01700985|183140981|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
91624487|NCT01700985|183140982|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
91624488|NCT00067470|183140989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.0|STANDARD_ERROR_OF_MEAN|40.0||0.025||95.0|11.0|172.0|||Regression, Linear|||||172|11|0.025
91624489|NCT00067470|183140990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|2.9||0.053||95.0|-0.1|11.5|||Regression, Linear|The raw data were adjusted for the observed differences in baseline between the groups and fitted to a longitudinal repeated measures linear model.||||11.5|-0.1|0.053
91624490|NCT01148693|183140992|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%||||<0.05
91624491|NCT03970824|183141095|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|105.79|||||TWO_SIDED|90.0|97.19|115.16||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||115.16|97.19|
91662031|NCT02558491|183219543|OTHER|||||||0.78||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.78
91713796|NCT04010461|183319166|OTHER||cluster size|42.0||||0.54|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Active, testing whether the cluster size is greater than chance.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain.||||0.54
91624492|NCT03970824|183141095|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|92.63|||||TWO_SIDED|90.0|85.29|100.61||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||100.61|85.29|
91624493|NCT03970824|183141095|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.0|||||TWO_SIDED|90.0|90.06|106.63||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.63|90.06|
91624494|NCT03970824|183141096|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|107.3|||||TWO_SIDED|90.0|98.29|117.13||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||117.13|98.29|
91624495|NCT03970824|183141096|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|93.93|||||TWO_SIDED|90.0|86.08|102.5||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||102.50|86.08|
91624496|NCT03970824|183141096|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.79|||||TWO_SIDED|90.0|92.42|109.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||109.92|92.42|
91662032|NCT02558491|183219543|OTHER|||||||0.399||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.399
91624497|NCT03970824|183141097|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|101.89|||||TWO_SIDED|90.0|95.33|108.89||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||108.89|95.33|
91624498|NCT03970824|183141097|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.2|||||TWO_SIDED|90.0|91.91|104.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||104.92|91.91|
91624499|NCT03970824|183141097|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.05|||||TWO_SIDED|90.0|93.69|106.85||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.85|93.69|
91624500|NCT01192204|183141110|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|We used a 2-tailed Mann Whitney U test to evaluate these data.||Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)||||0.048
91624501|NCT01192204|183141110|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Statistical analyses reflect percent change pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|||Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)||||0.50
91624502|NCT01192204|183141111|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|specifically, we used the Wilcoxon matched-pairs signed rank test.||||||<0.002
91624503|NCT01192204|183141111|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|||||||0.036
91624504|NCT01192204|183141112|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||2-tailed unpaired t test|||||||0.002
91624505|NCT01192204|183141112|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||two-tailed unpaired t test|||||||0.16
91624506|NCT02146248|183141113|SUPERIORITY_OR_OTHER|||||||0.4795||||||The two-tailed P value equals 0.4795|McNemar|||McNemar paired. Hypothesis is no change in tubal patency status. All subjects know to have bilateral patency in one of the exams during natural cycle||||0.4795
91624507|NCT00425100|183141118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.1|<|0.0001||95.0|-3.2|-2.7||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-2.7|-3.2|<0.0001
91624508|NCT00425100|183141119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.4|<|0.0001||95.0|-2.0|-1.4||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-1.4|-2.0|<0.0001
91624509|NCT00425100|183141120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|4.8|<|0.0001||95.0|-5.4|-4.5||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-4.5|-5.4|<0.0001
91624510|NCT00425100|183141122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2 sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624511|NCT00425100|183141123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624512|NCT00425100|183141124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624513|NCT00425100|183141125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|1.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624514|NCT00425100|183141127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624515|NCT00425100|183141129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.6|STANDARD_DEVIATION|26.4|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624516|NCT00425100|183141130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.6|STANDARD_DEVIATION|26.6|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91662033|NCT02558491|183219543|OTHER|||||||0.824||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.824
91662034|NCT02558491|183219544|OTHER|||||||0.863||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.863
91662035|NCT02558491|183219544|OTHER|||||||0.965||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.965
91662036|NCT02558491|183219544|OTHER|||||||0.742||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.742
91662037|NCT02558491|183219545|OTHER|||||||0.158||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.158
91662038|NCT02558491|183219545|OTHER|||||||0.085||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.085
91662039|NCT02558491|183219545|OTHER|||||||0.055||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.055
91662040|NCT02558491|183219546|OTHER|||||||0.744||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.744
91791911|NCT00604214|183461558|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.313|TWO_SIDED|95.0|0.923|1.283||No adjustment for multiple comparisons.|Chi-squared|||The study was planned to have 80% power to detect a 20% relative risk reduction in 28-day all-cause mortality in drotrecogin alpha (activated) compared to placebo. The final power was 75% because of the lower than anticipated placebo mortality.||1.283|0.923|0.313
91791912|NCT00604214|183461559|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.54|TWO_SIDED|95.0|0.737|1.173||No adjustments for multiple comparisons.|Chi-squared|||||1.173|0.737|0.540
91481466|NCT02325791|182836284|SUPERIORITY||percentage treatment difference|-0.44|||||TWO_SIDED|95.0|-4.318|3.438||Analysis performed using CMH statistics with randomization stratum adjusted using Mantel-Haenzel (MH) method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.|Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each Suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.438|-4.318|
91481467|NCT02325791|182836288|SUPERIORITY||percentage treatment difference|-0.67|||||TWO_SIDED|95.0|-5.291|3.959|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.959|-5.291|
91662041|NCT02558491|183219546|OTHER|||||||0.248||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.248
91624517|NCT00425100|183141131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|27.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91662042|NCT02558491|183219546|OTHER|||||||0.225||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.225
91662043|NCT02558491|183219547|OTHER|||||||0.86||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.86
91662044|NCT02558491|183219547|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.522
91662045|NCT02558491|183219547|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.522
91662046|NCT02558491|183219548|OTHER|||||||0.301||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.301
91624518|NCT00425100|183141132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.8|STANDARD_DEVIATION|21.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624519|NCT00425100|183141133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.1|STANDARD_DEVIATION|22.8|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91662047|NCT02558491|183219549|OTHER|||||||0.189||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.189
91662048|NCT02558491|183219550|OTHER|||||||0.271||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.271
91791913|NCT00604214|183461560|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.181
91624520|NCT00425100|183141134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.7|STANDARD_DEVIATION|22.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624521|NCT00425100|183141136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.2|STANDARD_DEVIATION|14.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
91624522|NCT02219087|183141162|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
91624523|NCT02219087|183141163|SUPERIORITY_OR_OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
91624524|NCT02219087|183141164|SUPERIORITY_OR_OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
91624525|NCT02219087|183141165|SUPERIORITY_OR_OTHER|||||||0.385|||||||t-test, 2 sided|||||||0.385
91624526|NCT02219087|183141166|SUPERIORITY_OR_OTHER|||||||0.843|||||||Chi-squared|||||||0.843
91624527|NCT02219087|183141167|SUPERIORITY_OR_OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
91624528|NCT05127421|183141169|SUPERIORITY||Odds Ratio (OR)|2.81||||0.091|TWO_SIDED|95.0|0.83|9.47|||Cochran-Mantel-Haenszel|stratified by the stratification factor (face and/or neck Investigator's Global Assessment \[IGA\] score of 2 or 3 at screening).||||9.47|0.83|0.091
91624529|NCT05127421|183141169|SUPERIORITY||response rate difference|19.5|STANDARD_ERROR_OF_MEAN|10.23|||TWO_SIDED|95.0|-0.5|39.6|||||The 95% confidence interval was computed based on a large-sample normal approximation with continuity correction.|||39.6|-0.5|
91624530|NCT01714817|183141177|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.7264|TWO_SIDED|95.0|0.7077|1.6421|||Stratified logistic regression||Abatacept IV:Placebo IV 95%CI for Odds Ratio|||1.6421|0.7077|0.7264
91624531|NCT01714817|183141178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.4148|1.5956|||||Abatacept IV:Placebo IV|||1.5956|0.4148|
91624532|NCT01714817|183141179|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.17||||0.571|TWO_SIDED|95.0|-0.76|0.42|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.42|-0.76|0.571
91624533|NCT01714817|183141180|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.09||||0.561|TWO_SIDED|95.0|-0.41|0.22|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.22|-0.41|0.561
91624534|NCT01714817|183141183|SUPERIORITY||Estimate of Difference|1.651|||||TWO_SIDED|95.0|-7.595828|10.897784||||||CR - Day 365||10.897784|-7.595828|
91624535|NCT01714817|183141183|SUPERIORITY||Estimate of Difference|-0.8828|||||TWO_SIDED|95.0|-8.848056|7.082461||||||PR - Day 365||7.082461|-8.848056|
91624536|NCT01714817|183141183|SUPERIORITY||Estimate of Difference|-0.7682|||||TWO_SIDED|95.0|-10.446714|8.910353||||||NR - Day 365||8.910353|-10.446714|
91624537|NCT01714817|183141192|SUPERIORITY|Day 365|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.3251|6.2849||||||||6.2849|0.3251|
91624538|NCT01714817|183141192|SUPERIORITY|Day 729|Estimate of Difference vs Drug|3.4|||||TWO_SIDED|95.0|-8.4|15.1||||||||15.1|-8.4|
91624539|NCT01714817|183141212|SUPERIORITY||Estimate of Difference|-0.9682|||||TWO_SIDED|95.0|-4.760178|2.823876||||||Lupus treatment failure - Day 365||2.823876|-4.760178|
91624540|NCT01714817|183141212|SUPERIORITY||Estimate of Difference|-0.4707|||||TWO_SIDED|95.0|-4.588691|3.647365||||||Overall treatment failure - Day 365||3.647365|-4.588691|
91624541|NCT01714817|183141212|SUPERIORITY|Lupus treatment failure - Day 729|Estimate of Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.1||||||||6.1|-4.5|
91662049|NCT02825680|183219554|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||This analysis compares reach within the pre-intervention timeframe versus the post-intervention timeframe for each LEAP (intervention) and control case. Intention to treat analysis was used; all participating facilities randomized to the LEAP (intervention) arm were included whether or not they completed the intervention.||||.011
91791914|NCT00604214|183461561|SUPERIORITY_OR_OTHER|||||||0.733||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.733
91624542|NCT01714817|183141212|SUPERIORITY|Overall treatment failure - Day 729|Estimate of Difference|2.7|||||TWO_SIDED|95.0|-3.3|8.8||||||||8.8|-3.3|
91624543|NCT02555657|183141227|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0574|TWO_SIDED|95.0|0.57|1.06|||Regression, Cox|||||1.06|0.57|0.0574
91624544|NCT02555657|183141228|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0728|TWO_SIDED|95.0|0.69|1.06|||Regression, Cox|||||1.06|0.69|0.0728
91624545|NCT02555657|183141229|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3802|TWO_SIDED|95.0|0.82|1.15|||Regression, Cox|||||1.15|0.82|0.3802
91624546|NCT02555657|183141230|SUPERIORITY||Difference in percentages|8.3||||0.0457|TWO_SIDED|95.0|-1.4|18.4|||Miettinen & Nurminen method|||||18.4|-1.4|0.0457
91624547|NCT02555657|183141231|SUPERIORITY||Difference in percentages|2.9||||0.1752|TWO_SIDED|95.0|-3.3|9.2|||Miettinen & Nurminen method|||||9.2|-3.3|0.1752
91624548|NCT02555657|183141232|SUPERIORITY||Difference in percentages|-1.0||||0.6629|TWO_SIDED|95.0|-5.9|3.8|||Miettinen & Nurminen method|||||3.8|-5.9|0.6629
91624549|NCT02555657|183141233|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7936|TWO_SIDED|95.0|0.82|1.59|||Regression, Cox|||||1.59|0.82|0.7936
91624550|NCT02555657|183141234|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.9964|TWO_SIDED|95.0|1.08|1.68|||Regression, Cox|||||1.68|1.08|0.9964
91624551|NCT02555657|183141235|SUPERIORITY||Hazard Ratio (HR)|1.6||||1|TWO_SIDED|95.0|1.33|1.92|||Regression, Cox|||||1.92|1.33|1.0000
91624552|NCT02555657|183141239|SUPERIORITY||Difference in percentages|2.3||||0.3388|TWO_SIDED|95.0|-8.7|13.5|||Miettinen & Nurminen method|||||13.5|-8.7|0.3388
91624553|NCT02555657|183141240|SUPERIORITY||Difference in percentages|-1.6||||0.6701|TWO_SIDED|95.0|-8.6|5.5|||Miettinen & Nurminen method|||||5.5|-8.6|0.6701
91624554|NCT02555657|183141241|SUPERIORITY||Difference in percentages|-6.5||||0.9877|TWO_SIDED|95.0|-12.2|-0.8|||Miettinen & Nurminen method|||||-0.8|-12.2|0.9877
91624555|NCT00405821|183141255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.99||P-value was adjusted to include multiple looks at data including an interim efficacy review at 50% and 75% accrual of person-years on study|Regression, Cox|adjusted for baseline log10 viral load, baseline CD4 count, gender, and age||Intent-to-treat analysis used Cox proportional hazards (CPH) models, adjusting for baseline log10 viral load (VL), CD4 cell count, gender and age to assess the risk of disease progression||0.99|0.58|<0.05
91624556|NCT00405821|183141256|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||<|0.05|TWO_SIDED|95.0|0.19|0.48||we included multiple GUD events per subject in the estimate of GUD incidence|rate ratio with 95% CI|||Null hypothesis is no difference by treatment arm in rate of GUD.||0.48|0.19|<0.05
91624557|NCT00405821|183141257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.463||||0.05|TWO_SIDED|95.0|-0.731|-0.194|||t-test, 2 sided|||Null hypothesis is no difference in annual rate of change in log10 viral load by arm.||-0.194|-0.731|0.05
91791915|NCT00604214|183461562|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.122
91791916|NCT00604214|183461563|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.042||||0.556|TWO_SIDED|95.0|0.909|1.193||No adjustments for multiple comparisons.|Chi-squared|||||1.193|0.909|0.556
91713797|NCT04010461|183319166|SUPERIORITY||cluster size|16.0||||0.93|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Control, testing whether the size of this cluster is greater than one would expect by chance alone.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain..||||0.93
91713798|NCT04010461|183319167|SUPERIORITY||F-ratio|0.22||||0.8|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to test for differences in cerebral blood flow (perfusion) in the frontoparietal network||||0.8
91713799|NCT04010461|183319168|SUPERIORITY||F-ratio|3.96||||0.06|TWO_SIDED||||||ANOVA|||||||0.06
91713800|NCT04010461|183319168|SUPERIORITY||F-ratio|0.17||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
91713801|NCT04010461|183319169|SUPERIORITY|Repeated measures ANOVA for 1- and 2-back conditions|F-ratio|0.72||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
91713802|NCT04010461|183319169|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
91481468|NCT02325791|182836288|SUPERIORITY||percentage treatment difference|2.02|||||TWO_SIDED|95.0|-2.836|6.867|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||6.867|-2.836|
91525096|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.229|=|0.05|TWO_SIDED|95.0|-0.83|0.07||1-sided p-value was reported.|MMRM|||Feelings of Heaviness|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|0.07|-0.83|=0.050
91525097|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.227|=|0.008|TWO_SIDED|95.0|-1.01|-0.1||1-sided p-value was reported.|MMRM|||Physical Fatigue|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.10|-1.01|=0.008
91624558|NCT02372097|183141261|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed AUC(0-168) of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|Least square (LS) mean difference|-0.017|||||TWO_SIDED|90.0|-0.0344|0.0004||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-168) as a dependent variable, and product, group and period as fixed effects.||0.0004|-0.0344|
91624559|NCT02372097|183141262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed Cmax of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|LS mean difference|-0.1292|||||TWO_SIDED|90.0|-0.2177|-0.0406||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the Cmax as a dependent variable, and product, group and period as fixed effects.||-0.0406|-0.2177|
91624560|NCT02372097|183141263|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.021||||||90.0|-0.0362|-0.0058||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-inf) as a dependent variable, and product, group and period as fixed effects.||-0.0058|-0.0362|
91624561|NCT02372097|183141264|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.375|||||TWO_SIDED|90.0|-0.1452|0.8952||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with Tmax as a dependent variable, and product, group and period as fixed effects.||0.8952|-0.1452|
91624562|NCT02372097|183141265|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.0168|||||TWO_SIDED|90.0|-0.0504|0.0169||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the MRT as a dependent variable, and product, group and period as fixed effects.||0.0169|-0.0504|
91624563|NCT02372097|183141266|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1099|||||TWO_SIDED|90.0|0.0235|0.1963||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the λz as a dependent variable, and product, group and period as fixed effects.||0.1963|0.0235|
91624564|NCT00713284|183141285|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91713803|NCT01462110|183319242|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.234|STANDARD_ERROR_OF_MEAN|0.0211|<|0.001|TWO_SIDED|95.0|-0.276|-0.192|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.192|-0.276|<0.001
91713804|NCT01462110|183319243|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-1.232|STANDARD_ERROR_OF_MEAN|0.0806|<|0.001|TWO_SIDED|95.0|-1.392|-1.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-1.071|-1.392|<0.001
91713805|NCT01462110|183319244|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.0173|<|0.001|TWO_SIDED|95.0|-0.14|-0.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.071|-0.140|<0.001
91791917|NCT00604214|183461564|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.758|TWO_SIDED|95.0|0.898|1.16||No adjustments for multiple comparisons.|Chi-squared|||||1.160|0.898|0.758
91662050|NCT05630885|183219555|SUPERIORITY||Slope|0.984||||0.65|TWO_SIDED|95.0|0.916|1.056||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use. Analysis used multiple imputation for missing data.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel, adjusting for statin-use. The study was powered to detect a between-group difference of 0.046 in log10 MDS TBR (10% relative fold-change), assuming a null difference of 0 in log10 MDS TBR (a ratio of 1 in absolute-scale), a standard deviation of 0.065 of change in log10 TBR, and 75 evaluable participants.||1.056|0.916|0.65
91713806|NCT01462110|183319245|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.0957|<|0.001|TWO_SIDED|95.0|-1.02|-0.639|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.639|-1.020|<0.001
91791918|NCT00604214|183461566|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.788
91527732|NCT01976364|182930503|OTHER||LS mean difference|-2.9|||||TWO_SIDED|95.0|-6.2|0.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.4|-6.2|
91624565|NCT04134728|183141293|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2868|TWO_SIDED|0.95|0.76|2.48|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12||2.48|0.76|0.2868
91624566|NCT04134728|183141293|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0596|TWO_SIDED|0.95|0.98|3.15|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and placebo in the percentage of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from placebo in the percentage of participants with ACR20 response at Week 12||3.15|0.98|0.0596
91624567|NCT04134728|183141293|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0049|TWO_SIDED|0.95|1.29|4.23|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 200 mg dose of Sarilumab alternating with placebo every week and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 200 mg dose of Sarilumab alternating with placebo every week differs from placebo in the proportion of participants with ACR20 response at Week 12||4.23|1.29|0.0049
91624568|NCT04134728|183141293|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0293|TWO_SIDED|0.95|0.36|0.95|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||0.95|0.36|0.0293
91624569|NCT04134728|183141293|SUPERIORITY||Odds Ratio (OR)|0.75||||0.2308|TWO_SIDED|0.95|0.47|1.2|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||1.20|0.47|0.2308
91624570|NCT03351478|183141416|SUPERIORITY||Difference in Least Square (LS) Means|-0.43|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.62|-0.25|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||-0.25|-0.62|< 0.0001
91624571|NCT03351478|183141416|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.145|TWO_SIDED|95.0|-0.04|0.28|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||0.28|-0.04|0.145
91624572|NCT03351478|183141417|SUPERIORITY||Difference in LS Means|-2.05|STANDARD_ERROR_OF_MEAN|1.43||0.1529|TWO_SIDED|95.0|-4.87|0.76|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||0.76|-4.87|0.1529
91624573|NCT03351478|183141417|SUPERIORITY||Difference in LS Means|1.17|STANDARD_ERROR_OF_MEAN|1.21||0.3377|TWO_SIDED|95.0|-1.21|3.55|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||3.55|-1.21|0.3377
91791919|NCT00604214|183461566|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.730
91481469|NCT00718237|182836295|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|80.2|||<|0.001|TWO_SIDED|95.0|47.4|94.1||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||94.1|47.4|<0.001
91481470|NCT00718237|182836296|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|74.5|||<|0.001|TWO_SIDED|95.0|39.9|90.6||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||90.6|39.9|<0.001
91481471|NCT00718237|182836297|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|100.0|||<|0.001|TWO_SIDED|95.0|55.4|100.0||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||100.0|55.4|<0.001
91624574|NCT03351478|183141418|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||-0.5|-1.33|<0.0001
91624575|NCT03351478|183141418|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.8397|TWO_SIDED|95.0|-0.37|0.3|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥ 130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||0.3|-0.37|0.8397
91624576|NCT03351478|183141419|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0005|TWO_SIDED|95.0|-1.25|-0.35|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.35|-1.25|0.0005
91662051|NCT05630885|183219555|OTHER|Statistical test for interaction.||||||0.4||||||P-value for modification of the CVC treatment effect by subgroups defined by statin-use is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by statin-use at study entry (use versus no-use).||||0.40
91662052|NCT05630885|183219555|OTHER|Statistical test for interaction.||||||0.63||||||P-value for modification of the CVC treatment effect by subgroups defined by sex is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for sex (F vs M) and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by sex (female versus male).||||0.63
91713807|NCT01462110|183319246|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0076|<|0.001|TWO_SIDED|95.0|-0.059|-0.029|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.029|-0.059|<0.001
91713808|NCT01462110|183319247|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.0087|<|0.001|TWO_SIDED|95.0|-0.078|-0.043|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.043|-0.078|<0.001
91791920|NCT00604214|183461566|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.662
91481472|NCT00322153|182836309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.001|TWO_SIDED|95.0|1.0|4.2|||ANCOVA|Least-squares mean (-0.4 in placebo and 2.2 in memantine ER) are controlled for center and adjusted for SIB baseline value.||The co-primary efficacy parameter was change from Baseline to Week 24 in SIB total score. Missing SIB total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||4.2|1.0|0.001
91481473|NCT00322153|182836310|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||The co-primary efficacy parameter was CIBIC-Plus total score at week 24. Missing CIBIC-Plus total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||||0.008
91481474|NCT00322153|182836311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.177|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|Least-squares mean (-1.7 in placebo and -1.0 in memantine ER) are controlled for center and adjusted for ADCS-ADL19 baseline value.||The secondary efficacy parameter was change from Baseline at Week 24 in the total score of the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL19). Missing scores at week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||1.8|-0.3|0.177
91481475|NCT02380690|182836342|SUPERIORITY|ECLIPSE was powered to detect an effect size of 0.45.||||||0.981||||||Statistical significance was set at p\<0.05|Regression, Linear|||||||0.981
91525098|NCT03324880|182925474|SUPERIORITY||Difference in LS Mean|-0.51|STANDARD_ERROR_OF_MEAN|0.186|=|0.004|TWO_SIDED|95.0|-0.87|-0.14||1-sided p-value was reported.|MMRM|||Brain Fog|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.14|-0.87|=0.004
91525099|NCT03324880|182925476|SUPERIORITY||Difference in LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|0.235|<|0.001|TWO_SIDED|95.0|-1.37|-0.43||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD most bothersome symptom score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD most bothersome symptom score.|-0.43|-1.37|<0.001
91525100|NCT03324880|182925477|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog Perceived Cognitive Impairments Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog Perceived Cognitive Impairments Subscale score.|4.3|0.0|=0.024
91525101|NCT03324880|182925478|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog QoL Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog QoL Subscale score.|4.3|0.0|=0.024
91525102|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|7.21|STANDARD_ERROR_OF_MEAN|2.1376|=|0.001|TWO_SIDED|95.0|2.951|11.469||1-sided p-value was reported.|MMRM|||Standard-Bodily Pain|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|11.469|2.951|=0.001
91525103|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|5.545|STANDARD_ERROR_OF_MEAN|2.0542|=|0.004|TWO_SIDED|95.0|1.452|9.638||1-sided p-value was reported.|MMRM|||Standard-General Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.638|1.452|=0.004
91525104|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|7.857|STANDARD_ERROR_OF_MEAN|2.2913|<|0.001|TWO_SIDED|95.0|3.292|12.423||1-sided p-value was reported.|MMRM|||Standard-Mental Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.423|3.292|<0.001
91525105|NCT03324880|182925479|SUPERIORITY||MMRM|4.554|STANDARD_ERROR_OF_MEAN|2.1123|=|0.017|TWO_SIDED|95.0|0.345|8.763||1-sided p-value was reported.|MMRM|||Standard-Physical Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.763|0.345|=0.017
91525106|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|8.42|STANDARD_ERROR_OF_MEAN|2.3186|<|0.001|TWO_SIDED|95.0|3.8|13.04||1-sided p-value was reported.|MMRM|||Standard-Role-Emotional|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|13.040|3.800|<0.001
91525107|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|4.23|STANDARD_ERROR_OF_MEAN|2.2489|=|0.032|TWO_SIDED|95.0|-0.251|8.711||1-sided p-value was reported.|MMRM|||Standard-Role-Physical|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.711|-0.251|=0.032
91525108|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|3.809|STANDARD_ERROR_OF_MEAN|2.6658|=|0.079|TWO_SIDED|95.0|-1.502|9.121||1-sided p-value was reported.|MMRM|||Standard-Social Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.121|-1.502|=0.079
91525109|NCT03324880|182925479|SUPERIORITY||Difference in LS Mean|7.942|STANDARD_ERROR_OF_MEAN|2.353|=|0.001|TWO_SIDED|95.0|3.253|12.63||1-sided p-value was reported.|MMRM|||Standard-Vitality|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.630|3.253|=0.001
91525110|NCT03324880|182925480|SUPERIORITY||Difference in LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.2642|<|0.001|TWO_SIDED|95.0|3.788|12.811||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 MCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 MCS score.|12.811|3.788|<0.001
91662053|NCT05630885|183219555|OTHER|Statistical test for interaction.||||||0.71||||||P-value for modification of the CVC treatment effect by subgroups defined by race is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for race and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by race (Black/African-American versus Non-Black/African-American).||||0.71
91791921|NCT00604214|183461566|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.846
91791922|NCT00604214|183461567|SUPERIORITY_OR_OTHER|||||||0.697||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.697
91791923|NCT00604214|183461567|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.306
91791924|NCT00604214|183461567|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.645
91624577|NCT03351478|183141419|SUPERIORITY||Difference in LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1339|TWO_SIDED|95.0|-0.09|0.7|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||0.7|-0.09|0.1339
91624578|NCT03351478|183141420|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.95|-1.54|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||-1.54|-2.95|<0.0001
91624579|NCT03351478|183141420|SUPERIORITY||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|0.34||0.1407|TWO_SIDED|95.0|-0.17|1.19|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||1.19|-0.17|0.1407
91624580|NCT03351478|183141421|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|0.95||0.0325|TWO_SIDED|95.0|-3.89|-0.17|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||-0.17|-3.89|0.0325
91662054|NCT05630885|183219556|SUPERIORITY||Slope|0.996||||0.91|TWO_SIDED|95.0|0.93|1.067||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.067|0.930|0.91
91662055|NCT05630885|183219556|SUPERIORITY||Slope|0.98||||0.64|TWO_SIDED|95.0|0.901|1.066||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.066|0.901|0.64
91791925|NCT00604214|183461567|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.690
91481476|NCT02380690|182836343|SUPERIORITY|||||||0.774|||||||Regression, Linear|||||||0.774
91481477|NCT02380690|182836344|SUPERIORITY|Power was based on primary outcome.||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.546.|Regression, Linear|||||||0.999
91481478|NCT02380690|182836345|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.403.|Regression, Linear|||||||0.999
91624581|NCT03351478|183141421|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1565|TWO_SIDED|95.0|-0.42|2.63|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||2.63|-0.42|0.1565
91624582|NCT03351478|183141422|SUPERIORITY||percentage difference|8.1||||0.0048|TWO_SIDED|95.0|3.36|12.89|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||12.89|3.36|0.0048
91624583|NCT03351478|183141423|SUPERIORITY||Percentage Difference|16.9||||0.0001|TWO_SIDED|95.0|9.26|24.52|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||24.52|9.26|0.0001
91624584|NCT01106391|183141479|SUPERIORITY_OR_OTHER_LEGACY||Rate of technical success (%)|90.0|||||TWO_SIDED|95.0|79.5|96.2|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||96.2|79.5|
91624585|NCT01106391|183141480|SUPERIORITY_OR_OTHER_LEGACY||Rate of achieved primary safety(%)|97.0|||||TWO_SIDED|95.0|88.1|99.6|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||99.6|88.1|
91791926|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value is for physical component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.482
91481479|NCT02380690|182836346|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.452.|Regression, Linear|||||||0.999
91481480|NCT02380690|182836347|SUPERIORITY|||||||0.98||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.243.|Regression, Linear|||||||0.980
91481481|NCT02380690|182836348|SUPERIORITY|||||||0.864||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.133.|Regression, Linear|||||||0.864
91527733|NCT01976364|182930503|OTHER||LS mean difference|-1.5|||||TWO_SIDED|95.0|-5.8|2.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.7|-5.8|
91624586|NCT00150345|183141497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.493||||0.258|TWO_SIDED|95.0|0.129|1.755|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event IFI=yes is modeled.|Hypothesis: H0: rv - rp = 0 vs H1: rv - rp does not equal 0, where ri is rate of IFI (i=v for voriconazole group, i=p for deferred voriconazole group). Logit model (including important covariates) used. The adjusted odds ratio and 95 percent (%) confidence interval (CI) for adjusted odds ratio calculated. If 95% CI around odds ratio does not contain a value of 1, then the null hypothesis of equal rates of IFI between immediate voriconazole and deferred voriconazole to be rejected.||1.755|0.129|0.258
91624587|NCT00150345|183141498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.596|TWO_SIDED|95.0|0.398|1.696|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.696|0.398|0.596
91624588|NCT00150345|183141499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.864|TWO_SIDED|95.0|0.441|1.988|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.988|0.441|0.864
91624589|NCT00150345|183141500|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED||||||Log Rank|||||||0.955
91624590|NCT00150345|183141502|SUPERIORITY_OR_OTHER||Difference in % participants that died|5.85|||||TWO_SIDED|95.0|-5.08|16.78|||||Approximate 2-sided confidence interval (CI).|Difference in proportions expressed as a percent: immediate voriconazole versus (vs) deferred voriconazole treatment||16.78|-5.08|
91624591|NCT00150345|183141503|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.190
91624592|NCT00150345|183141504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.031|STANDARD_ERROR_OF_MEAN|10.888||0.049|TWO_SIDED|95.0|-44.004|-0.059||SAS PROC REG with SELECTION=STEPWISE option of SLENTRY=0.05 and SLSTAY=0.10 utilized. Stepwise option combined forward stepping (with a 0.05 level to enter) with elimination of variables already in model that do not stay significant at 0.10 level.|Regression, Linear|Variables: association with age, c-reactive protein, and time to continuous defervescence not significant at 0.05 level; not included in final model||Continuous defervescence achieved=Yes||-0.059|-44.004|0.049
91624593|NCT00150345|183141524|SUPERIORITY_OR_OTHER||Difference in percentages|2.51|||||TWO_SIDED|95.0|-14.96|19.97||||||Difference in proportions expressed as a percent: immediate voriconazole vs deferred voriconazole treatment||19.97|-14.96|
91624594|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for RVR at Week 4.||||0.000
91624595|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Linear|||Binary logistic regression for gender at Week 4.||||0.018
91624596|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 4.||||0.062
91624597|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for HCV genotype at Week 4.||||0.050
91662056|NCT05630885|183219557|SUPERIORITY||Slope|1.01||||0.79|TWO_SIDED|95.0|0.939|1.087||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.087|0.939|0.79
91662057|NCT05630885|183219557|SUPERIORITY||Slope|1.017||||0.69|TWO_SIDED|95.0|0.935|1.106||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.106|0.935|0.69
91662058|NCT05630885|183219558|SUPERIORITY||Slope|2.5||||0.49|TWO_SIDED|95.0|-4.6|9.6||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in fasting glucose from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting glucose adjusting for statin-use.||9.6|-4.6|0.49
91791927|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||P-value is for physical component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.584
91791928|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for physical component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.164
91624598|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 4.||||0.001
91624599|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 4.||||0.001
91624600|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for EVR at Week 12.||||0.037
91624601|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for gender at Week 12.||||0.018
91624602|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 12.||||0.092
91791929|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||P-value is for physical component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.666
91791930|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.786||95.0||||P-value is for mental component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.786
91713809|NCT02106351|183319295|SUPERIORITY||LS mean difference back transformed|-0.4||||0.0118|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of covariance (ANCOVA) on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived least squares (LS) means were back transformed to the original scale and the treatment difference determined.||||0.0118
91713810|NCT02106351|183319295|SUPERIORITY||LS mean difference back transformed|-0.7|||<|0.0001|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANCOVA on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||<0.0001
91713811|NCT02106351|183319296|SUPERIORITY||LS mean difference back transformed|0.2||||0.2043|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of variance (ANOVA) on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.2043
91713812|NCT02106351|183319296|SUPERIORITY||LS mean difference back transformed|0.2||||0.188|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANOVA on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.1880
91791931|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for mental component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.160
91624603|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 12.||||0.001
91481482|NCT02380690|182836349|SUPERIORITY|||||||0.78||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.102.|Regression, Linear|||||||0.780
91481483|NCT02380690|182836350|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.536.|Regression, Linear|||||||0.999
91624604|NCT01392742|183141533|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 12.||||0.042
91624605|NCT00618995|183141587|NON_INFERIORITY_OR_EQUIVALENCE|Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|0.97||||||90.0|0.8|1.18||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.18|0.8|
91624606|NCT00618995|183141587|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.77|1.14||||||||1.14|0.77|
91624607|NCT00618995|183141587|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.05||||||||1.05|0.71|
91624608|NCT00618995|183141587|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.84||||||90.0|0.69|1.02||||||||1.02|0.69|
91624609|NCT00618995|183141587|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.92||||||90.0|0.76|1.13||||||||1.13|0.76|
91624610|NCT00618995|183141587|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.9||||||90.0|0.74|1.09||||||||1.09|0.74|
91624611|NCT00618995|183141588|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.06||||||||1.06|0.84|
91624612|NCT00618995|183141588|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.05||||||||1.05|0.84|
91624613|NCT00618995|183141588|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
91624614|NCT00618995|183141588|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.54||||||90.0|0.48|0.6||||||||0.60|0.48|
91624615|NCT00618995|183141588|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.6||||||90.0|0.54|0.67||||||||0.67|0.54|
91624616|NCT00618995|183141588|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
91624617|NCT05067452|183141620|SUPERIORITY||Slope|-0.092|STANDARD_ERROR_OF_MEAN|0.721||0.9|TWO_SIDED|95.0|-1.59|1.4|||ANCOVA|||||1.40|-1.59|0.900
91624618|NCT05067452|183141621|SUPERIORITY||Slope|1.37|STANDARD_ERROR_OF_MEAN|0.945||0.146|TWO_SIDED|95.0|-0.478|3.23|||Mixed Models Analysis|||||3.23|-0.478|0.146
91624619|NCT05067452|183141622|SUPERIORITY||Risk Difference (RD)|0.235|STANDARD_ERROR_OF_MEAN|0.212||0.281|TWO_SIDED|95.0|-0.207|0.677|||ANCOVA|Linear regression used with the binary outcome (linear probability model)||||0.677|-0.207|0.281
91624620|NCT05067452|183141623|SUPERIORITY||Risk Difference (RD)|0.354|STANDARD_ERROR_OF_MEAN|0.211||0.094|TWO_SIDED|95.0|-0.06|0.768|||Mixed Models Analysis|Linear regression used with the binary outcome (linear probability model)||||0.768|-0.060|0.094
91624621|NCT05067452|183141624|SUPERIORITY||Slope|2.18|STANDARD_ERROR_OF_MEAN|5.11||0.669|TWO_SIDED|95.0|-7.83|12.2|||Mixed Models Analysis|||||12.2|-7.83|0.669
91624622|NCT05067452|183141625|SUPERIORITY||Slope|-0.024|STANDARD_ERROR_OF_MEAN|0.367||0.949|TWO_SIDED|95.0|-0.695|0.743|||Mixed Models Analysis|||||0.743|-0.695|0.949
91624623|NCT05067452|183141626|SUPERIORITY||Slope|-0.54|STANDARD_ERROR_OF_MEAN|0.53||0.308|TWO_SIDED|95.0|-1.58|0.679|||Mixed Models Analysis|||||0.679|-1.58|0.308
91624624|NCT05067452|183141627|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|1.91||0.593|TWO_SIDED|95.0|-4.77|0.499|||Mixed Models Analysis|||||0.499|-4.77|0.593
91624625|NCT05067452|183141628|SUPERIORITY||Slope|-2.63|STANDARD_ERROR_OF_MEAN|1.65||0.112|TWO_SIDED|95.0|-5.86|0.611|||Mixed Models Analysis|||||0.611|-5.86|0.112
91624626|NCT05067452|183141631|SUPERIORITY||Slope|-2.66|STANDARD_ERROR_OF_MEAN|2.85||0.349|TWO_SIDED|95.0|-8.25|2.92|||Mixed Models Analysis|||||2.92|-8.25|0.349
91624627|NCT01135017|183141632|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|-59.13|STANDARD_ERROR_OF_MEAN|0.275||0.0015|TWO_SIDED|95.0|-76.322|-29.457||No adjustment for multiplicity was made. The priori threshold for statistical significance was ≤0.05.|ANCOVA|ANCOVA model on log-transformed AF burden data with treatment arm as a fixed effect term and baseline log-transformed AF burden as a covariate|"Percent change in AF burden with dronedarone relative to placebo~LS Mean difference from the ANCOVA model on log-transformed AF burden data was exponentiated to convert back to percent change."|"The planned sample size of 286 participants was estimated to have 70% power to detect a reduction in mean AF burden of 30% relative to the placebo group.~Due to the smaller-than-planned sample size, the power to detect this difference was estimated to be only 44%, based on the original assumption. However, the power to detect larger treatment effects (\>40% reduction) remained high and the posthoc power to detect a 60% reduction in AF burden was 99%."||-29.457|-76.322|0.0015
91624628|NCT00763243|183141650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|2.17||0.766|TWO_SIDED|95.0|-1.44|1.89|||t-test, 2 sided|t(8)=0.31||Change during waiting period (no intervention); no change was hypothesized||1.89|-1.44|0.766
91624629|NCT00763243|183141650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.0|<|0.001|TWO_SIDED|95.0|0.9|2.44|||t-test, 2 sided|t(8)=5.0||Change during the training period||2.44|0.90|<0.001
91624630|NCT00763243|183141650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|STANDARD_DEVIATION|1.86||0.021|TWO_SIDED|95.0|0.35|3.2|||t-test, 2 sided|t(8)=2.87||Change from pre-training through follow-up period||3.20|0.35|0.021
91624631|NCT00763243|183141650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|1.12||0.4|TWO_SIDED|95.0|-0.53|1.19|||t-test, 2 sided|t(8)=0.89||Change from pretraining to 6 month follow up||1.19|-0.53|0.40
91624632|NCT00763243|183141651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|2.24||0.11|TWO_SIDED|95.0|-0.39|3.05|||t-test, 2 sided|t(8)=1.79||Change during waiting period of no intervention||3.05|-0.39|0.11
91624633|NCT00763243|183141651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_DEVIATION|1.81||0.004|TWO_SIDED|95.0|1.05|3.84|||t-test, 2 sided|t(8)=4.05||Change during training period||3.84|1.05|0.004
91624634|NCT00763243|183141651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|STANDARD_DEVIATION|3.06||0.072|TWO_SIDED|95.0|-0.24|4.46|||t-test, 2 sided|t(8)=2.07||1 Month Follow Up change from pre-training||4.46|-0.24|0.072
91624635|NCT00763243|183141651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|2.28||0.34|TWO_SIDED|95.0|-0.97|2.53|||t-test, 2 sided|t(8)=1.02||6 month follow up change from pre-training||2.53|-0.97|0.34
91624636|NCT00763243|183141652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|1.86||0.729|TWO_SIDED|95.0|-1.2|1.65|||t-test, 2 sided|t(8)=0.36||Waiting period - no treatment||1.65|-1.20|0.729
91624637|NCT00763243|183141652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|2.17||0.039|TWO_SIDED|95.0|-3.44|-0.11|||t-test, 2 sided|t(8)=2.46||Training Period - Pretraining to Post-Training Visit||-0.11|-3.44|0.039
91624638|NCT00763243|183141652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_DEVIATION|2.98||0.4|TWO_SIDED|95.0|-3.17|1.4|||t-test, 2 sided|t(8)=0.90||1 Month Follow Up Period from Pretraining||1.40|-3.17|0.40
91662059|NCT05630885|183219559|SUPERIORITY||Slope|1.07||||0.62|TWO_SIDED|95.0|0.81|1.43||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in fasting insulin from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting insulin adjusting for statin-use.||1.43|0.81|0.62
91662060|NCT05630885|183219559|SUPERIORITY||Slope|1.09||||0.61|TWO_SIDED|95.0|0.78|1.54||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in HOMA-IR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of HOMA-IR adjusting for statin-use.||1.54|0.78|0.61
91662061|NCT05630885|183219560|SUPERIORITY||Slope|0.97||||0.91|TWO_SIDED|95.0|0.62|1.52||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in hsCRP from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of hsCRP adjusting for statin-use.||1.52|0.62|0.91
91481484|NCT02380690|182836351|SUPERIORITY|||||||0.997||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.340.|Regression, Linear|||||||0.997
91624639|NCT00763243|183141652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED|95.0|-2.59|1.26|||t-test, 2 sided|t(8)=0.89||6 Month Follow Up period from pretraining||1.26|-2.59|0.40
91624640|NCT00507416|183141691|SUPERIORITY_OR_OTHER|||||||0.458||||||The global difference among arms was based on the Wald test.|Wald test|||||||0.458
91624641|NCT03418051|183141720|SUPERIORITY|||||||0.824||||||A priori alpha level was set to 0.05|ANOVA|||||||0.824
91624642|NCT03418051|183141720|SUPERIORITY|||||||0.426||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.426
91624643|NCT03418051|183141721|SUPERIORITY|||||||0.722||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.722
91624644|NCT03418051|183141721|SUPERIORITY|||||||0.843||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.843
91624645|NCT03418051|183141722|SUPERIORITY|||||||0.046||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.046
91624646|NCT03418051|183141722|SUPERIORITY|||||||0.845||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.845
91624647|NCT03418051|183141723|SUPERIORITY|||||||0.138||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.138
91624648|NCT03418051|183141723|SUPERIORITY|||||||0.523||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.523
91624649|NCT03418051|183141724|SUPERIORITY|||||||0.069||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.069
91662062|NCT05630885|183219560|SUPERIORITY||Slope|1.01||||0.94|TWO_SIDED|95.0|0.77|1.33||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in IL-6 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of IL-6 adjusted for statin-use.||1.33|0.77|0.94
91525111|NCT03324880|182925481|SUPERIORITY||Difference in LS Mean|3.13|STANDARD_ERROR_OF_MEAN|9.578|=|0.627|TWO_SIDED|95.0|-16.33|22.6||1-sided p-value was reported.|MMRM|||Percent Work Time Missed Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|22.60|-16.33|=0.627
91624650|NCT03418051|183141724|SUPERIORITY|||||||0.413||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.413
91624651|NCT03418051|183141725|SUPERIORITY|||||||0.604||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.604
91624652|NCT03418051|183141725|SUPERIORITY|||||||0.499||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.499
91624653|NCT03418051|183141726|SUPERIORITY|||||||0.005||||||A priori threshold was set at 0.05.|ANOVA|||||||0.005
91624654|NCT03418051|183141726|SUPERIORITY|||||||0.853||||||A priori threshold set at 0.05.|ANOVA|||||||0.853
91624655|NCT03418051|183141727|SUPERIORITY|||||||0.142||||||A priori threshold set to 0.05|ANOVA|||||||0.142
91624656|NCT03418051|183141727|SUPERIORITY|||||||0.167||||||A priori threshold set at 0.05.|ANOVA|||||||0.167
91624657|NCT03418051|183141728|SUPERIORITY|||||||0.849||||||A priori alpha set at 0.05.|ANOVA|||||||0.849
91624658|NCT03418051|183141728|SUPERIORITY|||||||0.993||||||A priori threshold set at 0.05.|ANOVA|||||||0.993
91624659|NCT03418051|183141729|SUPERIORITY|||||||0.535||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.535
91624660|NCT03418051|183141729|SUPERIORITY|||||||0.569||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.569
91624661|NCT03418051|183141730|SUPERIORITY|||||||0.405||||||A priori threshold was 0.05.|ANOVA|||||||0.405
91791932|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value is for mental component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.696
91624662|NCT03418051|183141730|SUPERIORITY|||||||0.229||||||A priori threshold set to 0.05.|ANOVA|||||||0.229
91624663|NCT03418051|183141731|SUPERIORITY|||||||0.609||||||A priori threshold set at 0.05.|ANOVA|||||||0.609
91624664|NCT03418051|183141731|SUPERIORITY|||||||0.027||||||A priori threshold was set at 0.05.|ANOVA|||||||0.027
91624665|NCT03418051|183141732|SUPERIORITY|||||||0.613||||||A priori alpha set at 0.05.|Independent sample Mann-Whitney U|||||||0.613
91624666|NCT03418051|183141733|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Independent sample Mann-Whitney U|||||||0.925
91624667|NCT03418051|183141734|SUPERIORITY|||||||0.641||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.641
91624668|NCT03418051|183141734|SUPERIORITY|||||||0.897||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.897
91624669|NCT03418051|183141735|SUPERIORITY|||||||0.561||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.561
91624670|NCT03418051|183141735|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.925
91624671|NCT03418051|183141736|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05|ANOVA|||||||0.233
91624672|NCT03418051|183141736|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05|ANOVA|||||||0.634
91624673|NCT03418051|183141737|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05.|ANOVA|||||||0.233
91624674|NCT03418051|183141737|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05.|ANOVA|||||||0.634
91624675|NCT03418051|183141738|SUPERIORITY|||||||0.03||||||A priori threshold set at 0.05.|ANOVA|||||||0.030
91624676|NCT03418051|183141738|SUPERIORITY|||||||0.618||||||A priori threshold set at 0.05.|ANOVA|||||||0.618
91624677|NCT03418051|183141739|SUPERIORITY|||||||0.456||||||A priori threshold set at 0.05.|ANOVA|||||||0.456
91624678|NCT03418051|183141739|SUPERIORITY|||||||0.568||||||A priori threshold set to 0.05.|ANOVA|||||||0.568
91624679|NCT03418051|183141740|SUPERIORITY|||||||0.919||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.919
91624680|NCT03418051|183141740|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
91624681|NCT03418051|183141741|SUPERIORITY|||||||0.796||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.796
91624682|NCT03418051|183141741|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
91624683|NCT03418051|183141742|SUPERIORITY|||||||0.701||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.701
91624684|NCT03418051|183141742|SUPERIORITY|||||||0.68||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.68
91624685|NCT03418051|183141743|SUPERIORITY|||||||0.883||||||A priori threshold set at 0.05.|ANOVA|||||||0.883
91624686|NCT03418051|183141743|SUPERIORITY|||||||0.401||||||A priori threshold set at 0.05.|ANOVA|||||||0.401
91624687|NCT03418051|183141744|SUPERIORITY|||||||0.393||||||A priori threshold set at 0.05.|ANOVA|||||||0.393
91624688|NCT03418051|183141744|SUPERIORITY|||||||0.779||||||A priori threshold set at 0.05.|ANOVA|||||||0.779
91624689|NCT03418051|183141745|SUPERIORITY|||||||0.246||||||A priori threshold set at 0.05.|ANOVA|||||||0.246
91624690|NCT03418051|183141745|SUPERIORITY|||||||0.191||||||A priori threshold set at 0.05.|ANOVA|||||||0.191
91624691|NCT03418051|183141746|SUPERIORITY|||||||0.703||||||A priori threshold set at 0.05.|ANOVA|||||||0.703
91624692|NCT03418051|183141746|SUPERIORITY|||||||0.282||||||A priori threshold set at 0.05.|ANOVA|||||||0.282
91624693|NCT03418051|183141747|SUPERIORITY|||||||0.925||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.925
91624694|NCT03418051|183141747|SUPERIORITY|||||||0.551||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.551
91624695|NCT03418051|183141748|SUPERIORITY|||||||0.506||||||A priori threshold set at 0.05.|ANOVA|||||||0.506
91624696|NCT03418051|183141748|SUPERIORITY|||||||0.753||||||A priori threshold at 0.05.|ANOVA|||||||0.753
91624697|NCT03418051|183141749|SUPERIORITY|||||||0.777||||||A priori threshold set at 0.05.|ANOVA|||||||0.777
91624698|NCT03418051|183141749|SUPERIORITY|||||||0.475||||||A priori threshold set at 0.05.|ANOVA|||||||0.475
91624699|NCT03418051|183141750|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
91624700|NCT03418051|183141750|SUPERIORITY|||||||0.042||||||A priori threshold set at 0.05.|ANOVA|||||||0.042
91624701|NCT03418051|183141751|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
91624702|NCT03418051|183141751|SUPERIORITY|||||||0.83||||||A priori threshold set at 0.05.|ANOVA|||||||0.830
91624703|NCT03418051|183141752|SUPERIORITY|||||||0.7||||||A priori threshold set at 0.05.|ANOVA|||||||0.700
91624704|NCT03418051|183141752|SUPERIORITY|||||||0.492||||||A priori threshold set at 0.05.|ANOVA|||||||0.492
91624705|NCT03418051|183141753|SUPERIORITY|||||||0.82||||||A priori threshold set at 0.05.|ANOVA|||||||0.820
91662063|NCT05630885|183219560|SUPERIORITY||Slope|4.74|||<|0.001|TWO_SIDED|95.0|3.89|5.77||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MCP-1 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MCP-1 adjusting for statin-use.||5.77|3.89|<0.001
91662064|NCT05630885|183219561|SUPERIORITY||Slope|-49.0||||0.38|TWO_SIDED|95.0|-158.0|60.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD14 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of sCD14 adjusting for statin-use.||60|-158|0.38
91713813|NCT02106351|183319297|SUPERIORITY||LS mean difference|0.5||||0.7648|TWO_SIDED|95.0|-2.7|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.7|0.7648
91713814|NCT02106351|183319297|SUPERIORITY||LS mean difference|0.5||||0.7429|TWO_SIDED|95.0|-2.6|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.6|0.7429
91624706|NCT03418051|183141753|SUPERIORITY|||||||0.526||||||A priori threshold set at 0.05.|ANOVA|||||||0.526
91662065|NCT05630885|183219561|SUPERIORITY||Slope|-6.3||||0.88|TWO_SIDED|95.0|-87.0|75.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD163 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of sCD163 adjusting for statin-use.||75|-87|0.88
91713815|NCT04754542|183319323|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0121||||0.124|TWO_SIDED|95.0|-0.1321|0.1287|||Exact binomial test|Exact binomial test fr difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1287|-0.1321|0.124
91713816|NCT04754542|183319324|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
91525112|NCT03324880|182925481|SUPERIORITY||Difference in LS Mean|-14.6|STANDARD_ERROR_OF_MEAN|7.52|=|0.031|TWO_SIDED|95.0|-29.9|0.7||1-sided p-value was reported.|MMRM|||Percent Impairment While Working Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|0.7|-29.9|=0.031
91624707|NCT01769469|183141798|OTHER|||||||0.2085|||||||Wilcoxon (Mann-Whitney)|||Test of difference at Week 48 from baseline||||0.2085
91624708|NCT01769469|183141802|SUPERIORITY|||||||0.2452|||||||Wilcoxon Signed Rank Test|||||||0.2452
91624709|NCT01769469|183141810|SUPERIORITY|||||||0.0806|||||||Wilcoxon Signed Rank Test|||||||.0806
91624710|NCT01769469|183141821|OTHER|||||||0.6545|||||||Wilcoxon Signed Rank Test|||||||0.6545
91624711|NCT01769469|183141825|OTHER|||||||0.8739|||||||Wilcoxon Signed Rank Test|||||||0.8739
91624712|NCT01769469|183141833|OTHER|||||||0.5014|||||||Wilcoxon Signed Rank Test|||||||0.5014
91624713|NCT01769469|183141834|OTHER|||||||0.2431|||||||Wilcoxon Signed Rank Test|||||||0.2431
91624714|NCT01769469|183141835|OTHER|||||||0.7209|||||||Wilcoxon Signed Rank Test|||||||0.7209
91624715|NCT01769469|183141836|OTHER|||||||0.5379|||||||Wilcoxon Signed Rank Test|||||||0.5379
91624716|NCT01769469|183141837|OTHER|||||||0.7986|||||||Wilcoxon Signed Rank Test|||||||0.7986
91624717|NCT01769469|183141857|OTHER|||||||0.8507|||||||Wilcoxon Signed Rank Test|||||||0.8507
91624718|NCT01769469|183141858|OTHER|||||||0.3483|||||||Wilcoxon Signed Rank Test|||||||0.3483
91624719|NCT01769469|183141865|OTHER|||||||0.4043|||||||Wilcoxon (Mann-Whitney)|||||||0.4043
91624720|NCT01769469|183141866|OTHER|||||||0.2927|||||||Wilcoxon (Mann-Whitney)|||||||0.2927
91624721|NCT01769469|183141867|OTHER|||||||0.1134|||||||Wilcoxon (Mann-Whitney)|||||||0.1134
91624722|NCT01769469|183141868|OTHER|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||||||0.5782
91624723|NCT01769469|183141869|OTHER|||||||0.8658|||||||Wilcoxon (Mann-Whitney)|||||||0.8658
91624724|NCT01769469|183141870|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
91624725|NCT01769469|183141871|OTHER|||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
91624726|NCT01769469|183141872|OTHER|||||||0.1172|||||||Wilcoxon (Mann-Whitney)|||||||0.1172
91624727|NCT01769469|183141873|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.1220
91624728|NCT01769469|183141874|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91624729|NCT01769469|183141876|OTHER|||||||0.7785|||||||Wilcoxon (Mann-Whitney)|||||||0.7785
91624730|NCT01769469|183141877|OTHER|||||||0.4933|||||||Wilcoxon (Mann-Whitney)|||||||0.4933
91624731|NCT01769469|183141878|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
91624732|NCT01769469|183141879|OTHER|||||||0.5161|||||||Wilcoxon (Mann-Whitney)|||||||0.5161
91624733|NCT01769469|183141880|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.5990
91662066|NCT05630885|183219562|SUPERIORITY||Slope|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.12||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MIP-1 beta from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MIP-1 beta adjusting for statin-use.||2.12|1.28|<0.001
91662067|NCT05630885|183219562|SUPERIORITY||Slope|1.02||||0.85|TWO_SIDED|95.0|0.82|1.28||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in RANTES from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of RANTES adjusting for statin-use.||1.28|0.82|0.85
91481485|NCT02380690|182836352|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.384.|Regression, Linear|||||||0.999
91527734|NCT01976364|182930503|OTHER||LS mean difference|-6.3|||||TWO_SIDED|95.0|-10.2|-2.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||-2.4|-10.2|
91624734|NCT01769469|183141881|OTHER|||||||0.8579|||||||Wilcoxon (Mann-Whitney)|||||||0.8579
91624735|NCT01769469|183141882|OTHER|||||||0.0719|||||||Wilcoxon (Mann-Whitney)|||||||0.0719
91624736|NCT01769469|183141883|OTHER|||||||0.3148|||||||Wilcoxon (Mann-Whitney)|||||||0.3148
91624737|NCT01769469|183141884|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.1390
91624738|NCT01769469|183141885|OTHER|||||||0.2726|||||||Wilcoxon (Mann-Whitney)|||||||0.2726
91624739|NCT01769469|183141886|OTHER|||||||0.537|||||||Wilcoxon (Mann-Whitney)|||||||0.5370
91662068|NCT02354339|183219579|SUPERIORITY|||||||0.24||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis group||||0.240
91713817|NCT04754542|183319325|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||||||0.964
91624740|NCT01769469|183141887|OTHER|||||||0.2926|||||||Wilcoxon (Mann-Whitney)|||||||0.2926
91624741|NCT01769469|183141888|OTHER|||||||0.1906|||||||Wilcoxon (Mann-Whitney)|||||||0.1906
91624742|NCT01769469|183141889|OTHER|||||||0.2255|||||||Wilcoxon (Mann-Whitney)|||||||0.2255
91662069|NCT02354339|183219579|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.850
91713818|NCT04754542|183319326|SUPERIORITY|||||||0.819|||||||t-test, 2 sided|||||||0.819
91481486|NCT02380690|182836353|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.730.|Regression, Linear|||||||0.999
91481487|NCT02380690|182836354|SUPERIORITY|||||||0.914||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.161.|Regression, Linear|||||||0.914
91624743|NCT01769469|183141890|OTHER|||||||0.6285|||||||Wilcoxon (Mann-Whitney)|||||||0.6285
91624744|NCT01769469|183141891|OTHER|||||||0.0148|||||||Wilcoxon (Mann-Whitney)|||||||0.0148
91624745|NCT01769469|183141892|OTHER|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||||||0.0166
91624746|NCT01769469|183141893|OTHER|||||||0.0277|||||||Wilcoxon (Mann-Whitney)|||||||0.0277
91624747|NCT01769469|183141894|OTHER|||||||0.261|||||||Wilcoxon (Mann-Whitney)|||||||0.2610
91624748|NCT01769469|183141895|OTHER|||||||0.4154|||||||Wilcoxon (Mann-Whitney)|||||||0.4154
91624749|NCT01769469|183141896|OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||||||0.7125
91624750|NCT02713789|183141948|SUPERIORITY|||||||0.827|||||||ANCOVA|||SEP2||||0.827
91624751|NCT02713789|183141948|SUPERIORITY|||||||0.594|||||||ANCOVA|||SEP2||||0.594
91624752|NCT02713789|183141948|SUPERIORITY|||||||0.274|||||||ANCOVA|||SEP3||||0.274
91624753|NCT02713789|183141948|SUPERIORITY|||||||0.766|||||||ANCOVA|||SEP3||||0.766
91624754|NCT02713789|183141949|SUPERIORITY|||||||0.384|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.384
91624755|NCT02713789|183141949|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.144
91624756|NCT02713789|183141949|SUPERIORITY|||||||0.022|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.022
91624757|NCT02713789|183141949|SUPERIORITY|||||||0.137|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.137
91624758|NCT02713789|183141949|SUPERIORITY|||||||0.123|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.123
91624759|NCT02713789|183141950|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.160
91624760|NCT02713789|183141950|SUPERIORITY|||||||0.208|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.208
91624761|NCT02713789|183141950|SUPERIORITY|||||||0.316|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.316
91624762|NCT02713789|183141950|SUPERIORITY|||||||0.221|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.221
91624763|NCT02713789|183141950|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.172
91624764|NCT02713789|183141951|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.199
91624765|NCT02713789|183141951|SUPERIORITY|||||||0.203|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.203
91624766|NCT02713789|183141951|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.500
91624767|NCT02713789|183141951|SUPERIORITY|||||||0.296|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.296
91713819|NCT04754542|183319327|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
91713820|NCT04754542|183319328|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||||||0.388
91713821|NCT04754542|183319329|SUPERIORITY|||||||0.183|||||||t-test, 2 sided|||||||0.183
91662070|NCT02354339|183219580|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis group||||0.012
91624768|NCT02713789|183141951|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.286
91624769|NCT02713789|183141952|SUPERIORITY|||||||0.449|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.449
91624770|NCT02713789|183141952|SUPERIORITY|||||||0.381|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.381
91624771|NCT02713789|183141952|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.011
91624772|NCT02713789|183141952|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.05
91624773|NCT02713789|183141952|SUPERIORITY|||||||0.09|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.09
91624774|NCT02713789|183141953|SUPERIORITY|||||||0.074|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.074
91624775|NCT02713789|183141953|SUPERIORITY|||||||0.468|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.468
91624776|NCT02713789|183141953|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.109
91662071|NCT02354339|183219580|SUPERIORITY|||||||0.391||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.391
91624777|NCT02713789|183141953|SUPERIORITY|||||||0.493|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.493
91624778|NCT02713789|183141953|SUPERIORITY|||||||0.235|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.235
91624779|NCT02713789|183141954|SUPERIORITY|||||||0.136|||||||ANCOVA|||SEP1||||0.136
91662072|NCT02354339|183219581|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis group||||0.206
91624780|NCT02713789|183141954|SUPERIORITY|||||||0.498|||||||ANCOVA|||SEP1||||0.498
91624781|NCT02713789|183141954|SUPERIORITY|||||||0.369|||||||ANCOVA|||SEP4||||0.369
91624782|NCT02713789|183141954|SUPERIORITY|||||||0.337|||||||ANCOVA|||SEP4||||0.337
91624783|NCT02713789|183141954|SUPERIORITY|||||||0.16|||||||ANCOVA|||SEP5||||0.160
91624784|NCT00141037|183141965|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon Nonparametric Test|||The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.||||0.79
91624785|NCT00141037|183141966|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||The difference was analyzed using a Fisher's exact test.||||0.85
91624786|NCT00861380|183141973|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 =(vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
91624787|NCT00861380|183141974|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1vsControl). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
91624788|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|14.657|||||TWO_SIDED|95.0|13.229|16.197|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.197|13.229|
91662073|NCT02354339|183219581|SUPERIORITY|||||||0.721||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||0.721
91662074|NCT02354339|183219582|SUPERIORITY|||||||0.371||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis group||||0.371
91662075|NCT02354339|183219582|SUPERIORITY|||||||0.238||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.238
91662076|NCT02354339|183219583|SUPERIORITY|||||||0.452||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis group||||0.452
91662077|NCT02354339|183219583|SUPERIORITY|||||||0.801||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group||||0.801
91662078|NCT02354339|183219584|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis group||||0.005
91662079|NCT02354339|183219584|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group||||0.752
91662080|NCT02354339|183219585|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Irvingia gabonensis group||||0.791
91481488|NCT02380690|182836355|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.930.|Regression, Linear|||||||0.999
91481489|NCT02380690|182836356|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.379.|Regression, Linear|||||||0.999
91527735|NCT01976364|182930503|OTHER||LS mean difference|-2.8|||||TWO_SIDED|95.0|-7.3|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-7.3|
91662081|NCT02354339|183219585|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||0.910
91662082|NCT02354339|183219586|SUPERIORITY|||||||0.458||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis group||||0.458
91713822|NCT04754542|183319330|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
91662083|NCT02354339|183219586|SUPERIORITY|||||||0.953||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.953
91662084|NCT02354339|183219587|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis group||||0.470
91713823|NCT04754542|183319331|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||0.998
91481490|NCT02380690|182836357|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.969.|Regression, Linear|||||||0.999
91481491|NCT04854642|182836442|OTHER||Least square mean difference|71.62|||<|0.0001|TWO_SIDED|90.0|68.13|75.29|||ANOVA|||||75.29|68.13|<0.0001
91481492|NCT04854642|182836443|OTHER||Least square mean difference|90.93||||0.017|TWO_SIDED|90.0|85.3|96.93|||ANOVA|||||96.93|85.30|0.0170
91481493|NCT04854642|182836444|OTHER||Least square mean difference|90.9||||0.0213|TWO_SIDED|90.0|85.04|97.16|||ANOVA|||||97.16|85.04|0.0213
91481494|NCT04854642|182836445|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91481495|NCT01865084|182836468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.307
91481496|NCT01865084|182836468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.538||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.538
91481497|NCT03693170|182836479|OTHER|||||||||||||||||"The null hypothesis that the true response rate is 30% will be tested against a one-sided alternative.~The cORR will be provided with a corresponding Clopper-Pearson (exact) binomial 95% CI for the Efficacy Set.~This design yields a 1-sided type I error rate equal to 1.6% and power of 80% when the true response rate is 45%."|If 37 or more confirmed responses were observed in the 90 treated subjects with a centrally confirmed BRAFV600E mutation, corresponding to a lower limit of Clopper-Pearson (exact) binomial 95% CI exceeding 30%, the study was considered to have met its primary endpoint. If more than 90 subjects were enrolled, the lower limit of Clopper-Pearson was to be used for decision.|||
91481498|NCT00905827|182836556|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||<0.01
91662085|NCT02354339|183219587|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.807
91662086|NCT02354339|183219588|SUPERIORITY|||||||0.604||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis group||||0.604
91662087|NCT02354339|183219588|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group||||0.350
91662088|NCT02354339|183219589|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis group||||0.727
91713824|NCT04754542|183319332|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
91713825|NCT04754542|183319333|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.061
91713826|NCT04754542|183319334|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
91713827|NCT04754542|183319335|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||||||0.514
91713828|NCT04754542|183319336|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||0.017
91624789|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|13.582|||||TWO_SIDED|95.0|11.691|15.693|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.693|11.691|
91624790|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|8.452|||||TWO_SIDED|95.0|7.376|9.639|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.639|7.376|
91624791|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|7.603|||||TWO_SIDED|95.0|6.206|9.221|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.221|6.206|
91624792|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|1.637|||||TWO_SIDED|95.0|1.185|2.205|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.205|1.185|
91624793|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|1.845|||||TWO_SIDED|95.0|1.194|2.724|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.724|1.194|
91662089|NCT02354339|183219589|SUPERIORITY|||||||0.229||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.229
91662090|NCT02354339|183219590|SUPERIORITY|||||||0.151||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis group||||0.151
91662091|NCT02354339|183219590|SUPERIORITY|||||||0.955||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.955
91662092|NCT02354339|183219591|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis group||||0.350
91662093|NCT02354339|183219591|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo group||||0.470
91527736|NCT01976364|182930503|OTHER||LS mean difference|-4.9|||||TWO_SIDED|95.0|-9.9|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-9.9|
91713829|NCT04754542|183319337|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
91662094|NCT02354339|183219592|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis group||||0.910
91713830|NCT04754542|183319338|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||0.358
91713831|NCT04754542|183319339|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||||||0.151
91713832|NCT04754542|183319340|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
91481499|NCT00905827|182836556|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||0.01
91481500|NCT03347188|182836558|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1876|TWO_SIDED|95.0|-0.73|3.67||Threshold for significance at 0.05 level.|ANCOVA|||||3.67|-0.73|0.1876
91662095|NCT02354339|183219592|SUPERIORITY|||||||0.436||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.436
91481501|NCT03139604|182836581|OTHER||Odds Ratio (OR)|1.45||||0.0782|TWO_SIDED|95.0|0.959|2.204||Not adjusted for multiplicity with interim and final analyses|Cochran-Mantel-Haenszel|||binomial distribution||2.204|0.959|0.0782
91481502|NCT04543409|182836644|SUPERIORITY||Odds Ratio (OR)|117.49|||<|0.0001|TWO_SIDED|95.0|38.17|361.64|||Cochran-Mantel-Haenszel||The OR estimate and p-value was obtained from the CMH test controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. Odds ratio values \>1 favor Benra 30 mg treatment group.|Analysis completed at Week 24.||361.64|38.17|<0.0001
91481503|NCT04543409|182836645|SUPERIORITY|For any patients with intercurrent events, the DSQ scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.|Difference in Least Squares Means|2.999||||0.177|TWO_SIDED|95.0|-1.36|7.35|||ANCOVA|Model: Change from baseline in DSQ = Treatment + baseline DSQ + Region + Baseline steroid use + Presence of strictures at baseline.||Analysis completed at Week 24.||7.35|-1.36|0.1770
91481504|NCT04543409|182836646|SUPERIORITY|For any patients with intercurrent events, the Peak Esophageal intraepithelial eosinophil (eos) counts after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-96.2|||<|0.0001|TWO_SIDED|95.0|-114.53|-77.85|||ANCOVA|Model: Percent change from baseline in Peak Esophageal intraepithelial eos counts = Treatment + baseline Peak Esophageal intraepithelial eos counts.||Analysis completed at Week 24.||-77.85|-114.53|<0.0001
91481505|NCT04543409|182836647|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total grade score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.175|||<|0.0001|TWO_SIDED|95.0|-0.21|-0.14|||ANCOVA|Change from baseline in EoE-HSS TGS = Treatment + baseline EoE-HSS grade score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.14|-0.21|<0.0001
91481506|NCT04543409|182836648|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total stage score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.122|||<|0.0001|TWO_SIDED|95.0|-0.16|-0.09|||ANCOVA|Change from baseline in EoE-HSS TSS = Treatment + baseline EoE-HSS stage score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.09|-0.16|<0.0001
91481507|NCT04543409|182836649|SUPERIORITY|For any patients with intercurrent events, the centrally-read EREFS total score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.1||||0.7322|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|Model: Change from baseline in EREFS TS = Treatment + baseline EREFS TS + Region + Baseline steroid use + Presence of strictures at baseline||Analysis completed at Week 24.||0.32|-0.52|0.7322
91481508|NCT04543409|182836650|SUPERIORITY||Odds Ratio (OR)|15.86|||<|0.0001|TWO_SIDED|95.0|5.79|43.47|||Cochran-Mantel-Haenszel||Controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. OR values \>1 would favor Benra 30 mg treatment group.|||43.47|5.79|<0.0001
91481509|NCT04543409|182836654|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.04||||0.8656|TWO_SIDED|95.0|-0.5|0.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related pain.||0.42|-0.50|0.8656
91481510|NCT04543409|182836654|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.181||||0.3926|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related discomfort.||0.23|-0.60|0.3926
91481511|NCT04543409|182836654|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.344||||0.0867|TWO_SIDED|95.0|-0.74|0.05|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Overall episode severity.||0.05|-0.74|0.0867
91525113|NCT03324880|182925481|SUPERIORITY||Difference in LS Mean|-14.9|STANDARD_ERROR_OF_MEAN|6.146|=|0.011|TWO_SIDED|95.0|-27.42|-2.39||1-sided p-value was reported.|MMRM|||Percent Overall Work Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-2.39|-27.42|=0.011
91481512|NCT04543409|182836656|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.267||||0.2248|TWO_SIDED|95.0|-0.16|0.7|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Abdominal pain severity||0.70|-0.16|0.2248
91527737|NCT04250337|182930537|SUPERIORITY||Risk Difference (RD)|18.3||||0.011|TWO_SIDED|95.0|5.1|31.5|||Cochran-Mantel-Haenszel|||||31.5|5.1|0.011
91527738|NCT04250337|182930538|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|12.1|40.8|||Cochran-Mantel-Haenszel|||||40.8|12.1|<.001
91713833|NCT04754542|183319341|SUPERIORITY|||||||0.656|||||||Chi-squared|||||||0.656
91713834|NCT04754542|183319342|SUPERIORITY|||||||0.892|||||||Chi-squared|||||||0.892
91713835|NCT04754542|183319343|SUPERIORITY|||||||0.063|||||||Mantel Haenszel|Cochran-Mantel-Haenszel chi-square test for ordinal-nominal association was used||||||0.063
91481513|NCT04543409|182836656|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.296||||0.1575|TWO_SIDED|95.0|-0.11|0.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Nausea severity.||0.71|-0.11|0.1575
91481514|NCT04543409|182836659|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.202||||0.8239|TWO_SIDED|95.0|-1.57|1.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Eating/Diet Impact||1.98|-1.57|0.8239
91481515|NCT04543409|182836659|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.147||||0.7623|TWO_SIDED|95.0|-0.8|1.1|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social Impact||1.10|-0.80|0.7623
91481516|NCT04543409|182836659|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference of Least Squares Means|0.01||||0.9898|TWO_SIDED|95.0|-1.47|1.49|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Emotional Impact||1.49|-1.47|0.9898
91481517|NCT04543409|182836659|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.386||||0.4603|TWO_SIDED|95.0|-0.64|1.41|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Disease Anxiety||1.41|-0.64|0.4603
91527739|NCT04250337|182930539|SUPERIORITY||Risk Difference (RD)|18.9||||0.008|TWO_SIDED|95.0|6.1|31.7|||Cochran-Mantel-Haenszel|||||31.7|6.1|0.008
91527740|NCT04250337|182930540|SUPERIORITY||LS Mean Difference (Final Values)|-15.21|STANDARD_ERROR_OF_MEAN|6.373||0.017263|TWO_SIDED|95.0|-27.7|-2.7|||ANCOVA|||||-2.7|-27.7|0.017263
91624794|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as . 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 2626735.|PYAR|3.997|||||TWO_SIDED|95.0|3.269|4.839|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||4.839|3.269|
91624795|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 1354702.|PYAR|3.322|||||TWO_SIDED|95.0|2.423|4.445|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||4.445|2.423|
91662096|NCT02354339|183219593|SUPERIORITY|||||||0.989||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis group||||0.989
91662097|NCT02354339|183219593|SUPERIORITY|||||||0.949||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.949
91662098|NCT02354339|183219594|SUPERIORITY|||||||0.095||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis group||||0.095
91662099|NCT02354339|183219594|SUPERIORITY|||||||0.401||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.401
91662100|NCT02354339|183219595|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis group||||0.910
91662101|NCT02354339|183219595|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.791
91662102|NCT00730691|183219612|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.843||0.255|TWO_SIDED|95.0|-2.62|0.69||This treatment arm is not in the pre-specified testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05) comparing each of the 3 doses of vortioxetine to placebo.||0.69|-2.62|0.255
91713836|NCT04428385|183319360|SUPERIORITY||Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.34|2.16||||||||2.16|0.34|
91624796|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|14.487|||||TWO_SIDED|95.0|13.071|16.015|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.015|13.071|
91713837|NCT04428385|183319361|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.47|1.78||||||||1.78|0.47|
91713838|NCT04428385|183319362|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
91481518|NCT04543409|182836659|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.162||||0.6613|TWO_SIDED|95.0|-0.89|0.56|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Swallowing Anxiety||0.56|-0.89|0.6613
91481519|NCT04543409|182836659|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|1.017||||0.6965|TWO_SIDED|95.0|-4.09|6.13|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Total Score||6.13|-4.09|0.6965
91481520|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.3||||0.6852|TWO_SIDED|95.0|-1.93|1.27|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Physical functioning (PF)||1.27|-1.93|0.6852
91481521|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.2685|TWO_SIDED|95.0|-2.57|0.72|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to physical health (RP)||0.72|-2.57|0.2685
91481522|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.8||||0.538|TWO_SIDED|95.0|-3.27|1.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Bodily pain (BP)||1.71|-3.27|0.5380
91481523|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9734|TWO_SIDED|95.0|-1.81|1.75|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||General health perceptions (GH)||1.75|-1.81|0.9734
91481524|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9653|TWO_SIDED|95.0|-2.09|2.19|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Vitality (VT)||2.19|-2.09|0.9653
91481525|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-1.5||||0.2326|TWO_SIDED|95.0|-4.04|0.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social functioning (SF)||0.98|-4.04|0.2326
91481526|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.7||||0.6274|TWO_SIDED|95.0|-3.44|2.08|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to emotional problems (RE)||2.08|-3.44|0.6274
91481527|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.4599|TWO_SIDED|95.0|-3.14|1.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Mental health (MH)||1.42|-3.14|0.4599
91527741|NCT04250337|182930541|SUPERIORITY||Risk Difference (RD)|19.2||||0.017|TWO_SIDED|95.0|4.3|34.1|||Cochran-Mantel-Haenszel|||||34.1|4.3|0.017
91527742|NCT04250337|182930542|SUPERIORITY||Risk Difference (RD)|21.6||||0.007|TWO_SIDED|95.0|7.1|36.1|||Cochran-Mantel-Haenszel|||||36.1|7.1|0.007
91713839|NCT04428385|183319363|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.33|1.33||||||||1.33|0.33|
91713840|NCT04428385|183319364|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.62|1.9||||||||1.90|0.62|
91713841|NCT01064414|183319407|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.117||0.012|TWO_SIDED|95.0|-0.529|-0.066|||ANCOVA|||||-0.066|-0.529|0.012
91713842|NCT01064414|183319407|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-0.635|-0.174|||ANCOVA|||||-0.174|-0.635|<0.001
91525114|NCT03324880|182925481|SUPERIORITY||Difference in LS Mean|-13.0|STANDARD_ERROR_OF_MEAN|5.78|=|0.014|TWO_SIDED|95.0|-24.5|-1.5||1-sided p-value was reported.|MMRM|||Percent Activity Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-1.5|-24.5|=0.014
91525115|NCT03324880|182925482|SUPERIORITY||Difference in LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.22|=|0.01|TWO_SIDED|95.0|-1.0|-0.1||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in PGI-S score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline PGI-S score.|-0.1|-1.0|=0.010
91525116|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|0.01|||=|0.516|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|From an Analysis of Covariance (ANCOVA) with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Detection||0.05|-0.03|=0.516
91525117|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|0.02|||=|0.275|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Identification||0.06|-0.02|=0.275
91525118|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|0.01|||=|0.777|TWO_SIDED|95.0|-0.05|0.07|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Card Learning||0.07|-0.05|=0.777
91525119|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|0.01|||=|0.831|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Back (ONB)||0.05|-0.04|=0.831
91713843|NCT01064414|183319408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|||||3.77|0.73|0.227
91481528|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.4||||0.6456|TWO_SIDED|95.0|-2.07|1.28|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Psychometrically-based physical summary score (PCS)||1.28|-2.07|0.6456
91481529|NCT04543409|182836661|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.6||||0.6206|TWO_SIDED|95.0|-3.08|1.84|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Mental health component summary scores (MCS)||1.84|-3.08|0.6206
91481530|NCT01052844|182836673|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).||||0.04
91481531|NCT01052844|182836674|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||We evaluated associations between categorical variables using the Chi-Square test||||0.06
91481532|NCT01754909|182836698|SUPERIORITY|Occurrence rates, comparison by t test||||||0.05|||||||t-test, 2 sided|||||||0.05
91481533|NCT01466595|182836718|SUPERIORITY_OR_OTHER|||||||0.028||||||not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|no other adjustments||"Null hypothesis:~There is no difference between the two arms in the change in T-cell activation from baseline to week 4"||||0.028
91525120|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|9.93|||=|0.075|TWO_SIDED|95.0|-1.0|20.85|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Groton Maze Learning (GML)||20.85|-1.00|=0.075
91662103|NCT00730691|183219612|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.843||0.719|TWO_SIDED|95.0|-1.96|1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.35|-1.96|0.719
91713844|NCT01064414|183319408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.017|TWO_SIDED|95.0|1.19|6.04|||Regression, Logistic|||||6.04|1.19|0.017
91481534|NCT02313454|182836761|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.8||0.008|TWO_SIDED|95.0|-1.0|-0.19|||Paired t-test||Intranasal Application relative to the Extranasal Application|||-0.19|-1.0|0.008
91481535|NCT02313454|182836762|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|15.7||0.004|TWO_SIDED|95.0|-19.0|-3.4|||Paired t-test||Intranasal application relative to Extranasal application|||-3.4|-19.0|0.004
91481536|NCT00450112|182836763|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Fisher Exact|||||||>0.1
91525121|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|-0.57|||=|0.545|TWO_SIDED|95.0|-2.41|1.27|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List (ISL)||1.27|-2.41|=0.545
91525122|NCT03324880|182925484|SUPERIORITY||Difference in LS Mean|0.55|||=|0.283|TWO_SIDED|95.0|-0.45|1.56|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List Test Delayed Recall (ISRL)||1.56|-0.45|=0.283
91527743|NCT04250337|182930543|SUPERIORITY||LS Mean Difference (Final Values)|-23.64|STANDARD_ERROR_OF_MEAN|5.074||3e-06|TWO_SIDED|95.0|-33.6|-13.7|||ANCOVA|||||-13.7|-33.6|0.000003
91713845|NCT01064414|183319409|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|6.638||0.021|TWO_SIDED|95.0|-28.45|-2.307|||ANCOVA|||||-2.307|-28.45|0.021
91527744|NCT04250337|182930544|SUPERIORITY||LS Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|2.428|<|0.001|TWO_SIDED|95.0|-17.07|-7.49|||Mixed Models Analysis|||||-7.49|-17.07|<0.001
91713846|NCT01064414|183319409|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|6.683||0.069|TWO_SIDED|95.0|-25.36|0.962|||ANCOVA|||||0.962|-25.36|0.069
91481537|NCT00450112|182836764|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
91624797|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|13.74|||||TWO_SIDED|95.0|11.841|15.857|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.857|11.841|
91624798|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|7.813|||||TWO_SIDED|95.0|6.782|8.955|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||8.955|6.782|
91624799|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|7.789|||||TWO_SIDED|95.0|6.377|9.42|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.420|6.377|
91662104|NCT00730691|183219612|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.848||0.642|TWO_SIDED|95.0|-2.06|1.27||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.27|-2.06|0.642
91662105|NCT00730691|183219612|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.869||0.003|TWO_SIDED|95.0|-4.3|-0.89|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.89|-4.30|0.003
91662106|NCT00730691|183219613|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.511||0.83|TWO_SIDED|95.0|-0.89|1.11|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.11|-0.89|0.830
91662107|NCT00730691|183219613|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.643|TWO_SIDED|95.0|-1.24|0.77||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.77|-1.24|0.643
91662108|NCT00730691|183219613|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.517||0.036|TWO_SIDED|95.0|-2.1|-0.07||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.07|-2.10|0.036
91662109|NCT00730691|183219613|SUPERIORITY_OR_OTHER||LS mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.527||0.004|TWO_SIDED|95.0|-2.58|-0.5|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.50|-2.58|0.004
91662110|NCT00730691|183219614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.129||0.407|TWO_SIDED|95.0|-0.36|0.15|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.15|-0.36|0.407
91662111|NCT00730691|183219614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.129||0.533|TWO_SIDED|95.0|-0.33|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.33|0.533
91662112|NCT00730691|183219614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.491|TWO_SIDED|95.0|-0.34|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.34|0.491
91481538|NCT00450112|182836764|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
91481539|NCT00450112|182836765|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
91662113|NCT00730691|183219614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.133||0.001|TWO_SIDED|95.0|-0.7|-0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.17|-0.70|0.001
91481540|NCT00450112|182836765|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
91481541|NCT00450112|182836766|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
91481542|NCT00450112|182836766|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
91481543|NCT00450112|182836767|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..||||<0.0001
91481544|NCT00450112|182836767|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
91481545|NCT00450112|182836769|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
91481546|NCT00450112|182836769|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
91481547|NCT00450112|182836770|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
91481548|NCT00450112|182836770|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
91481549|NCT00559754|182836777|SUPERIORITY_OR_OTHER|||||||0.4915|||||||Fisher Exact|||||||0.4915
91481550|NCT00559754|182836778|SUPERIORITY_OR_OTHER|||||||0.4864|||||||Chi-squared|||||||0.4864
91481551|NCT00559754|182836779|SUPERIORITY_OR_OTHER|||||||0.3613|||||||Fisher Exact|||||||0.3613
91624800|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|2.313|||||TWO_SIDED|95.0|1.77|2.972|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.972|1.770|
91624801|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|1.984|||||TWO_SIDED|95.0|1.307|2.886|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.886|1.307|
91662114|NCT00730691|183219615|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.765||0.652|TWO_SIDED|95.0|-1.16|1.85|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.85|-1.16|0.652
91662115|NCT00730691|183219615|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.754||0.511|TWO_SIDED|95.0|-1.98|0.98|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.98|-1.98|0.511
91662116|NCT00730691|183219615|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.736||0.204|TWO_SIDED|95.0|-2.38|0.51|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.51|-2.38|0.204
91662117|NCT00730691|183219615|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.781||0.001|TWO_SIDED|95.0|-4.1|-1.03|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.03|-4.10|0.001
91791933|NCT00604214|183461568|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for mental component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.966
91481552|NCT00559754|182836780|SUPERIORITY_OR_OTHER|||||||0.6605|||||||Fisher Exact|||||||0.6605
91481553|NCT00559754|182836781|SUPERIORITY_OR_OTHER|||||||0.8311|||||||Fisher Exact|||||||0.8311
91481554|NCT00559754|182836782|SUPERIORITY_OR_OTHER|||||||0.223|||||||Fisher Exact|||||||0.2230
91481555|NCT00559754|182836783|SUPERIORITY_OR_OTHER|||||||0.8696|||||||Fisher Exact|||||||0.8696
91481556|NCT00559754|182836784|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Fisher Exact|||||||0.0074
91481557|NCT00559754|182836785|SUPERIORITY_OR_OTHER|||||||0.3235|||||||Fisher Exact|||||||0.3235
91481558|NCT00559754|182836786|SUPERIORITY_OR_OTHER|||||||0.0693|||||||Fisher Exact|||||||0.0693
91481559|NCT00559754|182836788|SUPERIORITY_OR_OTHER|||||||0.4254|||||||Fisher Exact|||||||0.4254
91481560|NCT00559754|182836790|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91481561|NCT00559754|182836791|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91481562|NCT00559754|182836793|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91481563|NCT03595774|182836801|SUPERIORITY|||||||0.0833||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0833
91662118|NCT00730691|183219616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.75|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.750|0.709|0.641
91481564|NCT03595774|182836802|SUPERIORITY|||||||0.0131||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0131
91481565|NCT03595774|182836803|SUPERIORITY|||||||0.012728||||||a prior threshold for significant of P\<0.05|ANOVA|Two-way ANOVA for repeated measured followed by Holm-Šídák's multiple comparisons test||||||0.012728
91481566|NCT03595774|182836804|SUPERIORITY|||||||2e-08||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.00000002
91624802|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =2636783.|PYAR|4.172|||||TWO_SIDED|95.0|3.429|5.028|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.028|3.429|
91624803|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =1360966.|PYAR|3.968|||||TWO_SIDED|95.0|2.981|5.177|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.177|2.981|
91624804|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|14.017|||||TWO_SIDED|95.0|12.628|15.516|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||15.516|12.628|
91662119|NCT00730691|183219616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.016||||0.945|TWO_SIDED|95.0|0.643|1.605|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.605|0.643|0.945
91662120|NCT00730691|183219616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.749|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.749|0.709|0.641
91662121|NCT00730691|183219616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.427||||0.124|TWO_SIDED|95.0|0.907|2.246|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||2.246|0.907|0.124
91662122|NCT00730691|183219617|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.346||0.064|TWO_SIDED|95.0|-5.15|0.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.14|-5.15|0.064
91662123|NCT00730691|183219617|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|1.353||0.096|TWO_SIDED|95.0|-4.92|0.4|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.40|-4.92|0.096
91662124|NCT00730691|183219617|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.397||0.25|TWO_SIDED|95.0|-4.36|1.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.14|-4.36|0.250
91662125|NCT00730691|183219617|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.54|STANDARD_ERROR_OF_MEAN|1.425||0.002|TWO_SIDED|95.0|-7.34|-1.73|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.73|-7.34|0.002
91662126|NCT01521780|183219648|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0803|||||ONE_SIDED|90.0||0.1163||||||||0.1163||
91662127|NCT01521780|183219649|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0555|||||ONE_SIDED|90.0||0.0733||||||||0.0733||
91713847|NCT00974311|183319410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.53|0.75|||Log Rank|Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.75|0.53|<0.0001
91662128|NCT04870606|183219654|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0181|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0181
91662129|NCT04870606|183219655|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.1223|ONE_SIDED||||||Chi-squared|||||||0.1223
91662130|NCT04870606|183219656|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0038|ONE_SIDED||||||t-test, 2 sided|||||||0.0038
91662131|NCT06298396|183219703|NON_INFERIORITY|A non-inferiority margin (NIM) of 10% was applied. In the sample size calculation, a 90% power to detect non-inferiority was used with a significance level α = 0.025 (one-tailed) was applied.|Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-2.92|2.81|||||Treatment difference = LP1 - Default Non-inferiority demonstrated if the lower limit of the two-sided 95% confidence interval was above -10% (i.e. LP1 - Default \> -10%).|||2.81|-2.92|
91662132|NCT06298396|183219704|NON_INFERIORITY|A non-inferiority margin (NIM) of 1 dB was applied. In the sample size calculation, a 90% power to detect non-inferiority was used with a significance level α = 0.025 (one-tailed) was applied.|Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.87|0.24|||||The non-inferiority margin is 1 dB. Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval is \< 1 dB.|||0.24|-0.87|
91662133|NCT06298396|183219705|NON_INFERIORITY|A non-inferiority margin (NIM) of 10% was applied. In the sample size calculation, a 90% power to detect non-inferiority was used with a significance level α = 0.025 (one-tailed) was applied.|Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-0.55|0.75|||||Treatment difference = LP2 - LP1 Non-inferiority demonstrated if the lower limit of the two-sided 95% confidence interval was above -10% (i.e. LP2 - LP1 \> -10%).|||0.75|-0.55|
91662134|NCT06298396|183219706|NON_INFERIORITY|A non-inferiority margin (NIM) of 1 dB was applied. In the sample size calculation, a 90% power to detect non-inferiority was used with a significance level α = 0.025 (one-tailed) was applied.|Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.55|0.75|||||Treatment difference = LP2 - LP1 Non-inferiority demonstrated if the lower limit of the two-sided 95% confidence interval was \< 1 dB (i.e. LP2- LP1 \< 1 dB)|||0.75|-0.55|
91662135|NCT06298396|183219707|NON_INFERIORITY|A non-inferiority margin (NIM) of 10% was applied. In the sample size calculation, a 90% power to detect non-inferiority was used with a significance level α = 0.025 (one-tailed) was applied.|Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-5.15|1.95|||||||Treatment difference = LP3 - LP1 Non-inferiority demonstrated if the lower limit of the two-sided 95% confidence interval was \< 1 dB (i.e. LP3 - LP1 \< 1 dB)|1.95|-5.15|
91713848|NCT00974311|183319411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.35|0.47|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.47|0.35|<0.0001
91481567|NCT03595774|182836805|SUPERIORITY|||||||0.017215||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.017215
91481568|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs. Timolol|Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-1.45|-0.13||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 2 and timolol||-0.13|-1.45|
91481569|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.24|||||TWO_SIDED|95.0|-1.92|-0.56||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 2 and timolol||-0.56|-1.92|
91481570|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.86|0.51||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 2 and timolol||0.51|-0.86|
91481571|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.43|-0.11||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 2 and timolol||-0.11|-1.43|
91481572|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.63|0.82||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 2 and timolol||0.82|-0.63|
91527745|NCT04250337|182930545|SUPERIORITY||Risk Difference (RD)|3.5||||0.454|TWO_SIDED|95.0|-4.9|11.8|||Cochran-Mantel-Haenszel|||||11.8|-4.9|0.454
91662136|NCT06298396|183219708|NON_INFERIORITY|non-inferiority margin (NIM) of 1 dB was applied. In the sample size calculation, a 90% power to detect non-inferiority was used with a significance level α = 0.025 (one-tailed) was applied.|Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-1.1|0.32|||||Treatment difference = LP3 - LP1 Non-inferiority demonstrated if the lower limit of the two-sided 95% confidence interval was \< 1 dB (i.e. LP3- LP1 \< 1 dB)|||0.32|-1.10|
91662137|NCT00836004|183219710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|99.69||||||90.0|93.88|105.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.85|93.88|
91662138|NCT00836004|183219711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.62|102.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.19|90.62|
91662139|NCT00836004|183219712|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.17||||||90.0|92.14|102.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.48|92.14|
91713849|NCT00974311|183319412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0001|TWO_SIDED|95.0|0.566|0.835|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.835|0.566|0.0001
91481573|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.89|0.57||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 2 and timolol||0.57|-0.89|
91624805|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|15.066|||||TWO_SIDED|95.0|13.079|17.269|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||17.269|13.079|
91624806|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.916|||||TWO_SIDED|95.0|5.026|6.917|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||6.917|5.026|
91624807|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|8.557|||||TWO_SIDED|95.0|7.077|10.255|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.255|7.077|
91624808|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =2654010.|PYAR|2.977|||||TWO_SIDED|95.0|2.357|3.71|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||3.710|2.357|
91624809|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =1367343.|PYAR|2.048|||||TWO_SIDED|95.0|1.361|2.96|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.960|1.361|
91624810|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.011|||||TWO_SIDED|95.0|4.196|5.939|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.939|4.196|
91713850|NCT00974311|183319413|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|24.9|||<|0.0001|TWO_SIDED|95.0|18.8|30.9|||Cochran-Mantel-Haenszel|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Confidence Interval based on standard normal approximation.|||30.9|18.8|<0.0001
91791934|NCT00604214|183461569|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||P-value is for participants with ≥1 event. No adjustments for multiple comparisons.|Fisher Exact|||||||0.758
91527746|NCT04250337|182930546|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-20.14|STANDARD_ERROR_OF_MEAN|12.81||0.117607|TWO_SIDED|95.0|-45.4|5.1|||ANCOVA|||||5.1|-45.4|0.117607
91662140|NCT02718963|183219716|OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare the Videofluoroscopic swallowing study(VFSS) kinematic variables, VDS, PAS, and high resolution manometry (HRM) variables between the neuromuscular electrical stimulation session and the control session in swallowing thin fluid and thick fluid for healthy, dysphagic and whole participants. Mann-Whitney test was used to compare the differences of VFSS variables, VDS, PAS, and HRM variables between the healthy participants and dysphagic participants.||||< 0.05
91662141|NCT00836472|183219721|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.41||||||90.0|88.43|105.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.10|88.43|
91662142|NCT00836472|183219722|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.78||||||90.0|95.14|102.57|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.57|95.14|
91481574|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.72|||||TWO_SIDED|95.0|-1.38|-0.06||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 1 vs. Timolol||-0.06|-1.38|
91481575|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.83|-0.48||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 1 vs. Timolol||-0.48|-1.83|
91662143|NCT00836472|183219723|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.52||||||90.0|94.44|102.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.78|94.44|
91662144|NCT00836472|183219724|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.08||||||90.0|89.6|98.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.77|89.60|
91662145|NCT00836472|183219725|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.33||||||90.0|92.6|100.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.21|92.60|
91662146|NCT00836472|183219726|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.01||||||90.0|92.18|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.00|92.18|
91713851|NCT00974311|183319414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.248|||<|0.0001|TWO_SIDED|95.0|0.204|0.303||Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Log Rank||Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.303|0.204|<0.0001
91713852|NCT00974311|183319415|SUPERIORITY_OR_OTHER||Difference in Rate of Pain Palliation|38.2||||0.0079|TWO_SIDED|95.0|19.4|57.0|||Cochran-Mantel-Haenszel|Stratified by baseline Eastern Cooperative Oncology Group performance status (0-1 vs. 2).|Confidence Interval based on standard normal approximation.|||57.0|19.4|0.0079
91525123|NCT03324880|182925485|SUPERIORITY||Difference in LS Mean|0.01|||=|0.582|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Detection (DET)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.582
91527747|NCT04250337|182930547|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.025293|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.025293
91527748|NCT04250337|182930548|SUPERIORITY||Risk Difference (RD)|14.2||||0.022|TWO_SIDED|95.0|3.8|24.7|||Cochran-Mantel-Haenszel|||||24.7|3.8|0.022
91662147|NCT01695239|183219727|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91662148|NCT01695239|183219727|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91662149|NCT01695239|183219727|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91662150|NCT03246503|183219790|OTHER||Pearson correlation coefficient|0.82|||<|0.001|TWO_SIDED|95.0|0.77|0.87||statistical significance of Pearson correlation coefficient|Pearson correlation coefficient||Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.|Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.||.87|0.77|<.001
91662151|NCT03246503|183219791|OTHER|t-statistic from regression analysis|intercept of regression line|4.13|||<|0.001|TWO_SIDED|95.0|3.35|4.91|||Regression, Linear|||||4.91|3.35|<.001
91662152|NCT03246503|183219792|OTHER|t-statistic from regression analysis|Slope|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Regression, Linear|||||0.76|0.60|<.001
91713853|NCT00458003|183319425|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||.38
91713854|NCT00458003|183319426|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||.10
91713855|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.|Least Squares (LS) Mean Difference|32.4|||||TWO_SIDED|90.0|28.4|36.4||||||||36.4|28.4|
91713856|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|15.6|||||TWO_SIDED|90.0|11.7|19.6||||||||19.6|11.7|
91713857|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|20.3|||||TWO_SIDED|90.0|16.3|24.3||||||||24.3|16.3|
91481576|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.93|0.43||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 1 and timolol||0.43|-0.93|
91525124|NCT03324880|182925485|SUPERIORITY||Difference in LS Mean|0.01|||=|0.492|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Identification (IDN)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.492
91527749|NCT04250337|182930549|SUPERIORITY||Risk Difference (RD)|1.2||||0.764|TWO_SIDED|95.0|-7.3|9.7|||Cochran-Mantel-Haenszel|||||9.7|-7.3|0.764
91624811|NCT00861380|183141978|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|4.315|||||TWO_SIDED|95.0|3.285|5.566|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.566|3.285|
91624812|NCT00861380|183141986|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2626735.|PYAR|9.218|||||TWO_SIDED|95.0|9.103|9.335|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.335|9.103|
91624813|NCT00861380|183141986|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1354702.|PYAR|9.212|||||TWO_SIDED|95.0|9.052|9.375|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.375|9.052|
91624814|NCT00861380|183141986|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|10.5|||||TWO_SIDED|95.0|10.378|10.624|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.624|10.378|
91662153|NCT03673670|183219806|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.021||||0.168|TWO_SIDED|95.0|0.991|1.052|||ANCOVA|||||1.052|0.991|0.168
91662154|NCT03673670|183219806|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|0.995||||0.731|TWO_SIDED|95.0|0.966|1.025|||ANCOVA|||||1.025|0.966|0.731
91662155|NCT03673670|183219807|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.115|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.115
91662156|NCT03673670|183219807|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.111|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.111
91624815|NCT00861380|183141986|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|10.429|||||TWO_SIDED|95.0|10.259|10.601|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.601|10.259|
91624816|NCT00861380|183141986|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|10.118|||||TWO_SIDED|95.0|9.997|10.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.239|9.997|
91662157|NCT03673670|183219808|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.014||||0.303|TWO_SIDED|95.0|0.987|1.043|||ANCOVA|||||1.043|0.987|0.303
91662158|NCT03673670|183219809|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.027||||0.067|TWO_SIDED|95.0|0.998|1.057|||ANCOVA|||||1.057|0.998|0.067
91662159|NCT03673670|183219809|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.395|TWO_SIDED|95.0|0.984|1.042|||ANCOVA|||||1.042|0.984|0.395
91662160|NCT03673670|183219810|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.404|TWO_SIDED|95.0|0.984|1.039|||ANCOVA|||||1.039|0.984|0.404
91713858|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|23.6|||||TWO_SIDED|90.0|19.6|27.6||||||||27.6|19.6|
91481577|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-1.4|-0.08||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 1 and timolol||-0.08|-1.40|
91481578|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.62|0.83||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 1 and timolol||0.83|-0.62|
91481579|NCT03519386|182836833|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.77|0.69||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 1 and timolol||0.69|-0.77|
91713859|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.|LS Mean Difference|16.8|||||TWO_SIDED|90.0|12.8|20.8||||||||20.8|12.8|
91713860|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.|LS Mean Difference|12.1|||||TWO_SIDED|90.0|8.1|16.1||||||||16.1|8.10|
91481580|NCT05714644|182836835|SUPERIORITY|FIT-DNA hypothesized to be higher than FIT|Risk Difference (RD)|4.7||||0.05|TWO_SIDED|95.0|0.8|8.7|||Regression, Logistic|logistic regression models with generalized estimating equations to account for clustering of data within CHCs, adjusting for age and race/ethnicity||||8.7|0.8|0.05
91481581|NCT05714644|182836836|SUPERIORITY|FIT-DNA greater than FIT|Risk Difference (RD)|4.5|||<|0.05|TWO_SIDED|95.0|0.4|8.5|||Regression, Logistic|||||8.5|0.4|<0.05
91481582|NCT01582854|182836841|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.005|TWO_SIDED|95.0|-3.9|-0.7|||ANCOVA|||||-0.7|-3.9|0.005
91481583|NCT01582854|182836842|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74||0.122|TWO_SIDED|95.0|-2.6|0.3|||ANCOVA|||Month 3||0.3|-2.6|0.122
91624817|NCT00861380|183141986|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|9.921|||||TWO_SIDED|95.0|9.755|10.088|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.088|9.755|
91624818|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|22.624|||||TWO_SIDED|95.0|22.02|23.24|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||23.240|22.020|
91624819|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|22.747|||||TWO_SIDED|95.0|21.912|23.606|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||23.606|21.912|
91624820|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|24.503|||||TWO_SIDED|95.0|23.852|25.166|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||25.166|23.852|
91624821|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|26.236|||||TWO_SIDED|95.0|25.308|27.189|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.189|25.308|
91662161|NCT03673670|183219811|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.082||||0.001|TWO_SIDED|95.0|1.043|1.123|||ANCOVA|||||1.123|1.043|0.001
91662162|NCT03673670|183219811|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.061||||0.002|TWO_SIDED|95.0|1.023|1.101|||ANCOVA|||||1.101|1.023|0.002
91662163|NCT03673670|183219812|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.02||||0.096|TWO_SIDED|95.0|0.997|1.043|||ANCOVA|||||1.043|0.997|0.096
91713861|NCT03286218|183319427|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.|LS Mean Difference|8.79|||||TWO_SIDED|90.0|4.8|12.8||||||||12.8|4.8|
91481584|NCT01582854|182836842|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.5|-1.9|||ANCOVA|||Month 12||-1.9|-5.5|<0.001
91481585|NCT01582854|182836843|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.111|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||End of Infusion Period||0.7|-0.1|0.111
91481586|NCT01582854|182836843|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.27||0.016|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Month 3||1.2|0.1|0.016
91481587|NCT01582854|182836843|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.013|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Month 6||1.3|0.2|0.013
91481588|NCT01582854|182836843|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|0.3|1.7|||ANCOVA|||Month 12||1.7|0.3|0.003
91481589|NCT01582854|182836844|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.032|TWO_SIDED|95.0|0.9|19.5|||Chi-squared|||Month 3||19.5|0.9|0.032
91624822|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|27.502|||||TWO_SIDED|95.0|26.81|28.207|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||28.207|26.810|
91481590|NCT01582854|182836844|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.034|TWO_SIDED|95.0|0.8|19.5|||Chi-squared|||Month 6||19.5|0.8|0.034
91624823|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|26.1||||||95.0|25.171|27.055|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.055|25.171|
91624824|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|28.661|||||TWO_SIDED|95.0|27.958|29.377|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||29.377|27.958|
91624825|NCT00861380|183141994|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|29.835|||||TWO_SIDED|95.0|28.843|30.85|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||30.850|28.843|
91713862|NCT03286218|183319430|OTHER||LS Mean Difference|33.1|||||TWO_SIDED|90.0|28.5|37.7||||||Overall Drug Liking||37.7|28.5|
91713863|NCT03286218|183319430|OTHER||LS Mean Difference|18.6|||||TWO_SIDED|90.0|14.0|23.2||||||Overall Drug Liking||23.2|14.0|
91713864|NCT03286218|183319430|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.5|23.8||||||Overall Drug Liking||23.8|14.5|
91481591|NCT01582854|182836844|SUPERIORITY_OR_OTHER||Percent Difference|10.1||||0.035|TWO_SIDED|95.0|0.8|19.3|||Chi-squared|||Month 12||19.3|0.8|0.035
91481592|NCT01582854|182836845|SUPERIORITY_OR_OTHER||Percent Difference|-3.2||||0.251|TWO_SIDED|95.0|-8.5|2.1|||Fisher Exact|||Month 6||2.1|-8.5|0.251
91481593|NCT01582854|182836845|SUPERIORITY_OR_OTHER||Percent Difference|-4.0||||0.221|TWO_SIDED|95.0|-9.7|1.7|||Fisher Exact|||Month 12||1.7|-9.7|0.221
91481594|NCT01582854|182836846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||End of Infusion Period||0.1|-0.4|0.239
91481595|NCT01582854|182836846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.136|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Month 3||0.1|-0.5|0.136
91481596|NCT01582854|182836846|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.89|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||Month 6||0.2|-0.3|0.890
91481597|NCT01582854|182836846|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.455|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Month 12||0.2|-0.4|0.455
91481598|NCT03101267|182836853|SUPERIORITY||Adjusted mean difference|0.09||||0.777|TWO_SIDED|95.0|-0.52|0.69|||Mixed model for repeated measures (MMRM)|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.69|-0.52|0.777
91525125|NCT03324880|182925485|SUPERIORITY||Difference in LS Mean|0.01|||=|0.506|TWO_SIDED|95.0|-0.03|0.06||1-sided p-value was reported.|MMRM|||One Card Learning (OCL)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.06|-0.03|=0.506
91481599|NCT03101267|182836853|SUPERIORITY||Adjusted mean difference|-0.01||||0.983||95.0|-0.61|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.59|-0.61|0.983
91481600|NCT03101267|182836854|SUPERIORITY||Adjusted mean difference|0.17||||0.71|TWO_SIDED|95.0|-0.75|1.1|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||1.10|-0.75|0.710
91481601|NCT03101267|182836854|SUPERIORITY||Adjusted mean difference|0.07||||0.872|TWO_SIDED|95.0|-0.84|0.99|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||0.99|-0.84|0.872
91481602|NCT03101267|182836854|SUPERIORITY||Adjusted mean difference|0.18||||0.701|TWO_SIDED|95.0|-0.73|1.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||1.08|-0.73|0.701
91481603|NCT03101267|182836854|SUPERIORITY||Adjusted mean difference|-0.04||||0.925||95.0|-0.95|0.86|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||0.86|-0.95|0.925
91481604|NCT03101267|182836854|SUPERIORITY||Adjusted mean difference|0.16||||0.69|TWO_SIDED|95.0|-0.64|0.97|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.97|-0.64|0.690
91481605|NCT03101267|182836854|SUPERIORITY||Adjusted mean difference|0.07||||0.868|TWO_SIDED|95.0|-0.73|0.87|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.87|-0.73|0.868
91481606|NCT03101267|182836855|SUPERIORITY||Adjusted mean difference|0.07||||0.502|TWO_SIDED|95.0|-0.14|0.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.29|-0.14|0.502
91481607|NCT03101267|182836855|SUPERIORITY||Adjusted mean difference|-0.02||||0.879|TWO_SIDED|95.0|-0.23|0.2|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.20|-0.23|0.879
91481608|NCT03101267|182836855|SUPERIORITY||Adjusted mean difference|0.06||||0.444|TWO_SIDED|95.0|-0.1|0.22|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.22|-0.10|0.444
91481609|NCT03101267|182836855|SUPERIORITY||Adjusted mean difference|0.0||||0.987|TWO_SIDED|95.0|-0.16|0.16|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.16|-0.16|0.987
91481610|NCT03101267|182836855|SUPERIORITY||Adjusted mean difference|0.03||||0.645|TWO_SIDED|95.0|-0.12|0.18|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.18|-0.12|0.645
91481611|NCT03101267|182836855|SUPERIORITY||Adjusted mean difference|-0.07||||0.357|TWO_SIDED|95.0|-0.22|0.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.08|-0.22|0.357
91481612|NCT03101267|182836856|SUPERIORITY||Adjusted mean difference|0.12||||0.472|TWO_SIDED|95.0|-0.2|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.44|-0.20|0.472
91481613|NCT03101267|182836856|SUPERIORITY||Adjusted mean difference|-0.11||||0.497|TWO_SIDED|95.0|-0.43|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.21|-0.43|0.497
91481614|NCT03101267|182836856|SUPERIORITY||Adjusted mean difference|0.04||||0.821|TWO_SIDED|95.0|-0.28|0.36|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.36|-0.28|0.821
91481615|NCT03101267|182836856|SUPERIORITY||Adjusted mean difference|-0.13||||0.414|TWO_SIDED|95.0|-0.45|0.19|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.19|-0.45|0.414
91481616|NCT03101267|182836856|SUPERIORITY||Adjusted mean difference|0.12||||0.414|TWO_SIDED|95.0|-0.17|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.41|-0.17|0.414
91481617|NCT03101267|182836856|SUPERIORITY||Adjusted mean difference|0.08||||0.566|TWO_SIDED|95.0|-0.2|0.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.37|-0.20|0.566
91481618|NCT03101267|182836857|SUPERIORITY||Adjusted mean difference|-0.04||||0.822||95.0|-0.37|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.30|-0.37|0.822
91481619|NCT03101267|182836857|SUPERIORITY||Adjusted mean difference|0.09||||0.587|TWO_SIDED|95.0|-0.24|0.42|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.42|-0.24|0.587
91481620|NCT03101267|182836857|SUPERIORITY||Adjusted mean difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.30|0.975
91481621|NCT03101267|182836857|SUPERIORITY||Adjusted mean difference|0.0||||0.98|TWO_SIDED|95.0|-0.31|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.31|0.980
91527750|NCT04250337|182930550|SUPERIORITY||Risk Difference (RD)|1.9||||0.498|TWO_SIDED|95.0|-2.9|6.7|||Cochran-Mantel-Haenszel|||||6.7|-2.9|0.498
91713865|NCT03286218|183319430|OTHER||LS Mean Difference|24.3|||||TWO_SIDED|90.0|19.7|28.9||||||Overall Drug Liking||28.9|19.7|
91713866|NCT03286218|183319430|OTHER||LS Mean Difference|34.0|||||TWO_SIDED|90.0|29.1|38.9||||||Take drug again||38.9|29.1|
91624826|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|816.813|||||TWO_SIDED|95.0|815.226|818.392|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||818.392|815.226|
91662164|NCT03673670|183219812|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.002||||0.862|TWO_SIDED|95.0|0.979|1.025|||ANCOVA|||||1.025|0.979|0.862
91662165|NCT03673670|183219813|OTHER||Median Difference (Final Values)|0.0||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.945
91662166|NCT03673670|183219813|OTHER||Median Difference (Final Values)|0.0||||0.501|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.501
91481622|NCT03101267|182836857|SUPERIORITY||Adjusted mean difference|-0.07||||0.621|TWO_SIDED|95.0|-0.35|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.21|-0.35|0.621
91481623|NCT03101267|182836857|SUPERIORITY||Adjusted mean difference|-0.03||||0.831|TWO_SIDED|95.0|-0.31|0.25|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.25|-0.31|0.831
91481624|NCT03101267|182836858|SUPERIORITY||Adjusted mean difference|0.03||||0.864|TWO_SIDED|95.0|-0.29|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.35|-0.29|0.864
91481625|NCT03101267|182836858|SUPERIORITY||Adjusted mean difference|0.11||||0.502|TWO_SIDED|95.0|-0.21|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.43|-0.21|0.502
91481626|NCT03101267|182836858|SUPERIORITY||Adjusted mean difference|0.07||||0.652|TWO_SIDED|95.0|-0.25|0.4|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.40|-0.25|0.652
91481627|NCT03101267|182836858|SUPERIORITY||Adjusted mean difference|0.08||||0.633|TWO_SIDED|95.0|-0.25|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.41|-0.25|0.633
91481628|NCT03101267|182836858|SUPERIORITY||Adjusted mean difference|0.07||||0.596|TWO_SIDED|95.0|-0.2|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.35|-0.20|0.596
91481629|NCT03101267|182836858|SUPERIORITY||Adjusted mean difference|0.07||||0.621|TWO_SIDED|95.0|-0.21|0.34|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.34|-0.21|0.621
91481630|NCT03101267|182836859|SUPERIORITY||Adjusted mean difference|0.21||||0.336|TWO_SIDED|95.0|-0.22|0.65|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.65|-0.22|0.336
91481631|NCT03101267|182836859|SUPERIORITY||Adjusted mean difference|0.36||||0.102|TWO_SIDED|95.0|-0.07|0.8|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.80|-0.07|0.102
91662167|NCT01058668|183219820|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-3.8|-8.4|<0.001
91713867|NCT03286218|183319430|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.2|24.0||||||Take drug again||24.0|14.2|
91713868|NCT03286218|183319430|OTHER||LS Mean Difference|20.6|||||TWO_SIDED|90.0|15.7|25.6||||||Take drug again||25.6|15.7|
91481632|NCT03101267|182836859|SUPERIORITY||Adjusted mean difference|0.11||||0.625|TWO_SIDED|95.0|-0.34|0.56|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.56|-0.34|0.625
91481633|NCT03101267|182836859|SUPERIORITY||Adjusted mean difference|0.33||||0.145|TWO_SIDED|95.0|-0.12|0.78|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.78|-0.12|0.145
91527751|NCT04250337|182930551|SUPERIORITY||Risk Difference (RD)|15.6||||0.014|TWO_SIDED|95.0|5.3|25.9|||Cochran-Mantel-Haenszel|||||25.9|5.3|0.014
91662168|NCT01058668|183219820|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.2|-3.6|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-3.6|-8.2|<0.001
91481634|NCT03101267|182836859|SUPERIORITY||Adjusted mean difference|0.19||||0.364|TWO_SIDED|95.0|-0.22|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.59|-0.22|0.364
91481635|NCT03101267|182836859|SUPERIORITY||Adjusted mean difference|0.35||||0.082|TWO_SIDED|95.0|-0.05|0.76|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.76|-0.05|0.082
91527752|NCT04250337|182930552|SUPERIORITY||Risk Difference (RD)|1.1||||0.818|TWO_SIDED|95.0|-8.0|10.2|||Cochran-Mantel-Haenszel|||||10.2|-8.0|0.818
91713869|NCT03286218|183319430|OTHER||LS Mean Difference|25.3|||||TWO_SIDED|90.0|20.3|30.2||||||Take drug again||30.2|20.3|
91624827|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|841.176|||||TWO_SIDED|95.0|839.098|843.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||843.239|839.098|
91624828|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|702.245|||||TWO_SIDED|95.0|700.372|704.114|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for Acute Otitis Media (AOM)/Respiratory Tract Infections (RTI), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||704.114|700.372|
91624829|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|720.9|||||TWO_SIDED|95.0|718.355|723.435|||negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||723.435|718.355|
91624830|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|929.844|||||TWO_SIDED|95.0|928.755|930.923|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||930.923|928.755|
91624831|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|953.025|||||TWO_SIDED|95.0|951.77|954.257|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||954.257|951.770|
91624832|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|804.703|||||TWO_SIDED|95.0|803.017|806.38|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||806.380|803.017|
91662169|NCT01058668|183219821|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-0.4|-0.9|<0.001
91662170|NCT01058668|183219821|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-0.3|-0.9|<0.001
91662171|NCT02294786|183219831|SUPERIORITY||Difference in Percentages|-4.8||||0.775|TWO_SIDED|95.0|-29.2|20.0|||Chi-squared|||Cycle 1-3 (up to 9 weeks)||20.0|-29.2|0.775
91713870|NCT03286218|183319430|OTHER||LS Mean Difference|69.7|||||TWO_SIDED|90.0|62.1|77.4||||||Good effects||77.4|62.1|
91525126|NCT03324880|182925485|SUPERIORITY||Difference in LS Mean|0.01|||=|0.438|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||One Back Test|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.438
91481636|NCT03101267|182836860|SUPERIORITY||Adjusted mean difference|0.07||||0.623|TWO_SIDED|95.0|-0.21|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.35|-0.21|0.623
91525127|NCT03324880|182925486|SUPERIORITY||Difference in LS Mean|2.09|STANDARD_ERROR_OF_MEAN|0.871|=|0.991|TWO_SIDED|95.0|0.36|3.83||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in 24-hour urine calcium excretion as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline 24-Hour urine calcium excretion.|3.83|0.36|=0.991
91624833|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|818.66|||||TWO_SIDED|95.0|816.391|820.912|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||820.912|816.391|
91713871|NCT03286218|183319430|OTHER||LS Mean Difference|35.5|||||TWO_SIDED|90.0|27.9|43.2||||||Good effects||43.2|27.9|
91624834|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|916.079|||||TWO_SIDED|95.0|914.891|917.256|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||917.256|914.891|
91624835|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|928.568|||||TWO_SIDED|95.0|927.038|930.076|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||930.076|927.038|
91624836|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|796.894||||||95.0|795.175|798.605|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||798.605|795.175|
91624837|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|803.918|||||TWO_SIDED|95.0|801.571|806.25|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||806.250|801.571|
91662172|NCT00841698|183219914|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|97.34||||||90.0|91.67|103.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.35|91.67|
91662173|NCT00841698|183219915|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.46||||||90.0|90.22|98.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.89|90.22|
91713872|NCT03286218|183319430|OTHER||LS Mean Difference|52.0|||||TWO_SIDED|90.0|44.4|59.7||||||Good effects||59.7|44.4|
91481637|NCT03101267|182836860|SUPERIORITY||Adjusted mean difference|0.15||||0.288|TWO_SIDED|95.0|-0.13|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.43|-0.13|0.288
91527753|NCT04250337|182930553|SUPERIORITY||Risk Difference (RD)|2.0||||0.499|TWO_SIDED|95.0|-3.1|7.1|||Cochran-Mantel-Haenszel|||||7.1|-3.1|0.499
91662174|NCT00841698|183219916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.83||||||90.0|89.96|99.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.96|89.96|
91662175|NCT00838136|183219917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.23||||||90.0|99.88|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.60|99.88|
91662176|NCT00838136|183219918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.87||||||90.0|99.18|104.63|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.63|99.18|
91662177|NCT00838136|183219919|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.76||||||90.0|98.6|102.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.97|98.60|
91662178|NCT01149733|183219920|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|97.9|||||TWO_SIDED|90.0|91.0|105.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||105.32|91.00|
91662179|NCT01149733|183219921|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|91.81|||||TWO_SIDED|90.0|87.72|96.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||96.10|87.72|
91662180|NCT01149733|183219922|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|90.64|||||TWO_SIDED|90.0|86.59|94.89|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||94.89|86.59|
91481638|NCT03101267|182836860|SUPERIORITY||Adjusted mean difference|0.03||||0.83|TWO_SIDED|95.0|-0.24|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.30|-0.24|0.830
91662181|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.13|||||TWO_SIDED|95.0|-50.4|-5.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Fasting Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Fasting Value.||-5.86|-50.40|
91662182|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.16|||||TWO_SIDED|95.0|-51.68|-6.64|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.||-6.64|-51.68|
91662183|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.58|||||TWO_SIDED|95.0|-62.25|-10.9|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.||-10.90|-62.25|
91662184|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.41|||||TWO_SIDED|95.0|-72.8|-18.03|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.||-18.03|-72.80|
91662185|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.35|||||TWO_SIDED|95.0|-50.84|-7.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.||-7.86|-50.84|
91662186|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.14|||||TWO_SIDED|95.0|-45.8|-6.49|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean||-6.49|-45.80|
91713873|NCT03286218|183319430|OTHER||LS Mean Difference|53.0|||||TWO_SIDED|90.0|45.4|60.6||||||Good effects||60.6|45.4|
91713874|NCT03286218|183319430|OTHER||LS Mean Difference|20.4|||||TWO_SIDED|90.0|13.6|27.2||||||Bad effects||27.2|13.6|
91481639|NCT03101267|182836860|SUPERIORITY||Adjusted mean difference|0.17||||0.208|TWO_SIDED|95.0|-0.1|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.44|-0.10|0.208
91481640|NCT03101267|182836860|SUPERIORITY||Adjusted mean difference|0.06||||0.616|TWO_SIDED|95.0|-0.19|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.31|-0.19|0.616
91527754|NCT04250337|182930554|SUPERIORITY||LS Mean Difference (Final Values)|7.29|STANDARD_ERROR_OF_MEAN|5.104||0.155|TWO_SIDED|95.0|-2.78|17.36|||Mixed Models Analysis|||||17.36|-2.78|0.155
91624838|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|865.679|||||TWO_SIDED|95.0|864.227|867.121|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||867.121|864.227|
91624839|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|871.749|||||TWO_SIDED|95.0|869.771|873.707|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||873.707|869.771|
91624840|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|753.423|||||TWO_SIDED|95.0|751.591|755.249|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||755.249|751.591|
91662187|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0|||||TWO_SIDED|95.0|-55.41|-8.58|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.||-8.58|-55.41|
91662188|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.96|||||TWO_SIDED|95.0|-66.64|-15.29|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.||-15.29|-66.64|
91662189|NCT01929863|183219954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.76|||||TWO_SIDED|95.0|-54.67|-14.85|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.||-14.85|-54.67|
91662190|NCT01929863|183219955|SUPERIORITY_OR_OTHER||Ratio|1.013|||||TWO_SIDED|90.0|0.912|1.125|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-10 h).|||1.125|0.912|
91662191|NCT01929863|183219956|SUPERIORITY_OR_OTHER||Ratio|1.036|||||TWO_SIDED|90.0|0.937|1.145|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Cmax.|||1.145|0.937|
91481641|NCT03101267|182836860|SUPERIORITY||Adjusted mean difference|0.16||||0.207|TWO_SIDED|95.0|-0.09|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.41|-0.09|0.207
91662192|NCT01304641|183219981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91662193|NCT01304641|183219982|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.078||||0.14|TWO_SIDED|95.0|0.976|1.192|||Regression, Cox|||||1.192|0.976|0.140
91662194|NCT01304641|183219983|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91662195|NCT01304641|183219984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91662196|NCT01304641|183219985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91662197|NCT01304641|183219986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91662198|NCT01304641|183219987|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91662199|NCT00099047|183219988|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|0.05||0.23|TWO_SIDED||||||SAS version 8||36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.|||||.23
91662200|NCT03123471|183220072|SUPERIORITY||Difference in Response|29.6|||<|0.0001|TWO_SIDED|95.0|19.5|39.7|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||39.7|19.5|< 0.0001
91481642|NCT03101267|182836861|SUPERIORITY||Adjusted mean difference|0.15||||0.157|TWO_SIDED|95.0|-0.06|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.35|-0.06|0.157
91713875|NCT03286218|183319430|OTHER||LS Mean Difference|5.04|||||TWO_SIDED|90.0|-1.76|11.8||||||Bad effects||11.8|-1.76|
91525128|NCT03324880|182925487|SUPERIORITY||Difference in LS Mean|-0.175|STANDARD_ERROR_OF_MEAN|0.0395|<|0.001|TWO_SIDED|95.0|-0.254|-0.097||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in serum phosphate as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline serum phosphate.|-0.097|-0.254|<0.001
91624841|NCT00861380|183141998|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|755.542|||||TWO_SIDED|95.0|753.008|758.064|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||758.064|753.008|
91624842|NCT00637377|183142006|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.2|||||TWO_SIDED|95.0|-4.86|2.46|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q4).||2.46|-4.86|
91624843|NCT00637377|183142006|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.84|||||TWO_SIDED|95.0|-5.4|1.71|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 0.5mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 0.5mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 0.5mg Q4).||1.71|-5.40|
91713876|NCT03286218|183319430|OTHER||LS Mean Difference|7.28|||||TWO_SIDED|90.0|0.487|14.1||||||Bad effects||14.1|0.487|
91713877|NCT03286218|183319430|OTHER||LS Mean Difference|12.5|||||TWO_SIDED|90.0|5.69|19.3||||||Bad effects||19.3|5.69|
91481643|NCT03101267|182836861|SUPERIORITY||Adjusted mean difference|0.21||||0.039|TWO_SIDED|95.0|0.01|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.41|0.01|0.039
91481644|NCT03101267|182836861|SUPERIORITY||Adjusted mean difference|0.08||||0.459|TWO_SIDED|95.0|-0.14|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.30|-0.14|0.459
91481645|NCT03101267|182836861|SUPERIORITY||Adjusted mean difference|0.16||||0.153|TWO_SIDED|95.0|-0.06|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.38|-0.06|0.153
91481646|NCT03101267|182836861|SUPERIORITY||Adjusted mean difference|0.12||||0.195|TWO_SIDED|95.0|-0.06|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.31|-0.06|0.195
91481647|NCT03101267|182836861|SUPERIORITY||Adjusted mean difference|0.2||||0.038|TWO_SIDED|95.0|0.01|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.38|0.01|0.038
91481648|NCT03101267|182836862|SUPERIORITY||Adjusted mean difference|0.37||||0.433|TWO_SIDED|95.0|-0.56|1.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.29|-0.56|0.433
91481649|NCT03101267|182836862|SUPERIORITY||Adjusted mean difference|0.33||||0.479|TWO_SIDED|95.0|-0.59|1.24|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.24|-0.59|0.479
91481650|NCT03101267|182836862|SUPERIORITY||Adjusted mean difference|0.22||||0.648|TWO_SIDED|95.0|-0.71|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.71|0.648
91481651|NCT03101267|182836862|SUPERIORITY||Adjusted mean difference|0.21||||0.654|TWO_SIDED|95.0|-0.72|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.72|0.654
91481652|NCT03101267|182836862|SUPERIORITY||Adjusted mean difference|0.27||||0.514|TWO_SIDED|95.0|-0.55|1.09|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.09|-0.55|0.514
91481653|NCT03101267|182836862|SUPERIORITY||Adjusted mean difference|0.35||||0.4|TWO_SIDED|95.0|-0.47|1.17|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.17|-0.47|0.400
91481654|NCT03101267|182836863|SUPERIORITY||Adjusted mean difference,|0.39||||0.505|TWO_SIDED|95.0|-0.76|1.54||The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.|MMRM|||6TSS treatment comparison at day 127||1.54|-0.76|0.505
91713878|NCT03286218|183319430|OTHER||LS Mean Difference|75.4|||||TWO_SIDED|90.0|67.2|83.5||||||Any effects||83.5|67.2|
91624844|NCT00637377|183142006|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.13|||||TWO_SIDED|95.0|-4.81|2.55|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q8 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q8, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q8).||2.55|-4.81|
91624845|NCT00637377|183142007|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.9484||||0.076|TWO_SIDED|95.0|-4.1009|0.204||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||0.2040|-4.1009|0.076
91624846|NCT00637377|183142007|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.062||||0.9555|TWO_SIDED|95.0|-2.2398|2.1158||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||2.1158|-2.2398|0.9555
91624847|NCT00637377|183142007|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.9014||||0.4131|TWO_SIDED|95.0|-3.0615|1.2587||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||1.2587|-3.0615|0.4131
91527755|NCT04250337|182930556|SUPERIORITY||LS Mean Difference (Final Values)|-17.69|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-26.37|-9.01|||ANCOVA|||||-9.01|-26.37|<0.001
91624848|NCT00637377|183142008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.57||||0.229|TWO_SIDED|95.0|-12.02|2.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q4 group|The null hypothesis is that the two proportions are equal.||2.88|-12.02|0.229
91624849|NCT00637377|183142008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.78||||0.843|TWO_SIDED|95.0|-6.91|8.46||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 0.5mg Q4 group|The null hypothesis is that the two proportions are equal.||8.46|-6.91|0.843
91624850|NCT00637377|183142008|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.65||||0.49|TWO_SIDED|95.0|-10.18|4.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The null hypothesis is that the two proportions are equal.||4.88|-10.18|0.490
91624851|NCT00637377|183142009|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-2.7885||||0.0097|TWO_SIDED|95.0|-4.9012|-0.6757||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||-0.6757|-4.9012|0.0097
91624852|NCT00637377|183142009|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.932||||0.3917|TWO_SIDED|95.0|-3.0658|1.2019||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||1.2019|-3.0658|0.3917
91624853|NCT00637377|183142009|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.947||||0.0717|TWO_SIDED|95.0|-4.0659|0.1718||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||0.1718|-4.0659|0.0717
91662201|NCT03123471|183220073|SUPERIORITY||Difference in Response|23.0|||<|0.0001|TWO_SIDED|95.0|11.5|34.6|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||34.6|11.5|< 0.0001
91713879|NCT03286218|183319430|OTHER||LS Mean Difference|44.9|||||TWO_SIDED|90.0|36.8|53.0||||||Any effects||53.0|36.8|
91713880|NCT03286218|183319430|OTHER||LS Mean Difference|56.8|||||TWO_SIDED|90.0|48.7|64.9||||||Any effects||64.9|48.7|
91527756|NCT04250337|182930557|SUPERIORITY||LS Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.014||0.001031|TWO_SIDED|95.0|-5.3|-1.3|||ANCOVA|||||-1.3|-5.3|0.001031
91662202|NCT03123471|183220074|SUPERIORITY||Difference in Response|26.2|||<|0.0001|TWO_SIDED|95.0|13.9|38.5|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||38.5|13.9|< 0.0001
91481655|NCT03101267|182836863|SUPERIORITY||Adjusted mean difference,|0.44||||0.451|TWO_SIDED|95.0|-0.71|1.58|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 127||1.58|-0.71|0.451
91481656|NCT03101267|182836863|SUPERIORITY||Adjusted mean difference,|0.29||||0.623|TWO_SIDED|95.0|-0.88|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.88|0.623
91481657|NCT03101267|182836863|SUPERIORITY||Adjusted mean difference,|0.29||||0.62|TWO_SIDED|95.0|-0.87|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.87|0.620
91481658|NCT03101267|182836863|SUPERIORITY||Adjusted mean difference,|0.35||||0.504|TWO_SIDED|95.0|-0.68|1.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.37|-0.68|0.504
91481659|NCT03101267|182836863|SUPERIORITY||Adjusted mean difference,|0.42||||0.414|TWO_SIDED|95.0|-0.6|1.45|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.45|-0.60|0.414
91481660|NCT04644783|182836916|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
91481661|NCT04644783|182836917|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
91481662|NCT02290431|182836918|SUPERIORITY||||||<|0.0001|||||||single-sample binomial test|||||||< 0.0001
91527757|NCT04250337|182930558|SUPERIORITY||Risk Difference (RD)|17.2||||0.036|TWO_SIDED|95.0|0.1|34.3|||Cochran-Mantel-Haenszel|||||34.3|0.1|0.036
91481663|NCT03437512|182836945|SUPERIORITY||||||<|0.001||||||familywise error rate (FWE) corrected to .05 with cluster threshold of 80 voxels.|t-test, 2 sided|||||||<.001
91481664|NCT03437512|182836946|SUPERIORITY|||||||0.936||||||Interaction between visit and group.|ANOVA|||Analyses conduced with a mixed ANOVA, with between-subjects factor of group (active, sham) and two within-subjects factors: time (post, follow up) and speech task (reading, conversation).||||.936
91481665|NCT03437512|182836947|SUPERIORITY|||||||0.619||||||Interaction between visit and group.|ANOVA|||||||.619
91481666|NCT02417844|182836951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.66|STANDARD_DEVIATION|19.15|||TWO_SIDED|90.0|92.19|107.74|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||107.74|92.19|
91481667|NCT02417844|182836952|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.58|STANDARD_DEVIATION|13.51|||TWO_SIDED|90.0|94.23|105.24|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.24|94.23|
91481668|NCT02417844|182836953|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.48|STANDARD_DEVIATION|14.12|||TWO_SIDED|90.0|93.9|105.39|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.39|93.90|
91481669|NCT03332771|182836961|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% confidence interval (CI) for the adjusted mean difference is \<0.3.|Difference in Least Squares (LS) Mean|0.12|STANDARD_ERROR_OF_MEAN|0.122||0.3306|TWO_SIDED|95.0|-0.12|0.357|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.357|-0.120|0.3306
91481670|NCT03332771|182836961|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% CI for the adjusted mean difference is \<0.3.|Difference in LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7112|TWO_SIDED|95.0|-0.265|0.181|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.181|-0.265|0.7112
91481671|NCT03332771|182836962|SUPERIORITY||Difference in LS Mean|-0.21|STANDARD_ERROR_OF_MEAN|0.119||0.0827|TWO_SIDED|95.0|-0.44|0.027|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.027|-0.440|0.0827
91481672|NCT03332771|182836962|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.103||0.0003|TWO_SIDED|95.0|-0.571|-0.167|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.167|-0.571|0.0003
91481673|NCT03332771|182836963|SUPERIORITY||Difference in LS Mean|-1.49|STANDARD_ERROR_OF_MEAN|0.349|<|0.0001|TWO_SIDED|95.0|-2.173|-0.803|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups (placebo, sotagliflozin 200 mg, sotagliflozin 400 mg, glimepiride), randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of SBP (\<130,≥ 130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.803|-2.173|<0.0001
91481674|NCT03332771|182836963|SUPERIORITY||Difference in LS Mean|-3.58|STANDARD_ERROR_OF_MEAN|0.544|<|0.0001|TWO_SIDED|95.0|-4.651|-2.517|||ANCOVA|||The change from baseline to Week 52 is analyzed using analysis of ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects and baseline body weight as a covariate.||-2.517|-4.651|< 0.0001
91527758|NCT04250337|182930559|SUPERIORITY||LS Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.06|0.16|||ANCOVA|||Health State Index UK||0.16|0.06|<0.001
91662203|NCT03123471|183220075|SUPERIORITY||Difference in Response|17.0|||<|0.0001|TWO_SIDED|95.0|9.8|24.2|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.2|9.8|<0.0001
91481675|NCT03332771|182836964|SUPERIORITY||Difference in LS Mean|-4.18|STANDARD_ERROR_OF_MEAN|1.288||0.0012|TWO_SIDED|95.0|-6.701|-1.65|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.650|-6.701|0.0012
91481676|NCT03332771|182836964|SUPERIORITY||Difference in LS Mean|-2.7|STANDARD_ERROR_OF_MEAN|0.0973||0.0973|TWO_SIDED|95.0|-5.89|0.491|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.491|-5.890|0.0973
91481677|NCT03332771|182836965|SUPERIORITY||Difference in LS Mean|-4.02|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-5.73|-2.319|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-2.319|-5.730|<0.0001
91481678|NCT03332771|182836966|SUPERIORITY||Percentage difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.67|-11.12|||Cochran-Mantel-Haenszel|||Weighted average of percentage difference between treatment groups from each stratum \[randomization strata of HbA1c \[≤8.5%, \>8.5%\] at screening, randomization strata of mean SBP \[\<130, ≥130 mmHg\] at screening using Cochran-Mantel-Haenszel weights.||-11.12|-19.67|<0.0001
91481679|NCT03718871|182836980|SUPERIORITY||intracluster correlation coefficient|0.086|||<|0.001|TWO_SIDED|95.0|0.015|0.363||The threshold for significance was set at p \< 0.05.|Fisher Exact|||Given that the intervention arm showed 100% uptake, a multi-level regression model could not be created with a zero in the denominator in the intervention group. We therefore used Fisher's exact test to assess for significant differences in proportion of HIV testing between study arms.||0.363|0.015|<0.001
91481680|NCT03718871|182836981|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91481681|NCT03718871|182836982|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
91481682|NCT03718871|182836983|OTHER|No comparison between study arm groups was made in this analysis, as it was limited to control arm only.|Odds Ratio (OR)|1.04|STANDARD_DEVIATION|0.039|<|0.01|TWO_SIDED|95.0|1.02|1.06||Significance threshold two-sided alpha = 0.05|Regression, Linear|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.06|1.02|<0.01
91481683|NCT03718871|182836984|OTHER|No comparison was made with the intervention arm|Odds Ratio (OR)|0.56||||0.07|TWO_SIDED|95.0|0.3|1.04||Univariate analysis|Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.04|0.30|0.07
91525129|NCT03324880|182925488|SUPERIORITY||Difference in LS Mean|4.08|STANDARD_ERROR_OF_MEAN|4.654|=|0.81|TWO_SIDED|95.0|-5.06|13.22||1-sided p-value was reported.|MMRM||||From a mixed-effects model for repeated measures (MMRM) analysis over all post-baseline visits, with the change from baseline in active vitamin D supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline active vitamin D supplement dose.|13.22|-5.06|=0.810
91527759|NCT04250337|182930559|SUPERIORITY||LS Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018|<|0.001|TWO_SIDED|95.0|0.04|0.11|||ANCOVA|||Health State Index US||0.11|0.04|<0.001
91481684|NCT03718871|182836985|OTHER|Comparison between study arms was not performed|Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.16|1.18|||Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.18|0.16|0.09
91481685|NCT00737464|182836987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||||TWO_SIDED|||||||||||||
91713881|NCT03286218|183319430|OTHER||LS Mean Difference|64.8|||||TWO_SIDED|90.0|56.7|73.0||||||Any effects||73.0|56.7|
91481686|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-1.99|-0.5||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.50|-1.99|
91481687|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.88|-0.52||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.52|-1.88|
91713882|NCT03286218|183319430|OTHER||LS Mean Difference|68.6|||||TWO_SIDED|90.0|60.6|76.6||||||High||76.6|60.6|
91713883|NCT03286218|183319430|OTHER||LS Mean Difference|34.4|||||TWO_SIDED|90.0|26.4|42.4||||||High||42.4|26.4|
91624854|NCT00637377|183142010|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.18||||0.0038|TWO_SIDED|95.0|-1.979|-0.382||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||-0.382|-1.979|0.0038
91624855|NCT00637377|183142010|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.17||||0.6784|TWO_SIDED|95.0|-0.632|0.972||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.972|-0.632|0.6784
91624856|NCT00637377|183142010|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.733||||0.0727|TWO_SIDED|95.0|-1.534|0.068||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.068|-1.534|0.0727
91624857|NCT01293084|183142013|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2||||0.62|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.62
91624858|NCT01293084|183142014|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.3||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
91624859|NCT01375647|183142022|SUPERIORITY||Risk Difference (RD)|-2.9||||0.4|TWO_SIDED|95.0|-9.6|3.9|||Chi-squared|2 sided, not adjusted||||3.9|-9.6|0.4
91481688|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.76|0.69||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.69|-0.76|
91624860|NCT01375647|183142023|SUPERIORITY||Risk Difference (RD)|13.4||||4e-05|TWO_SIDED|95.0|7.0|19.8||2-sided, no adjustment|Chi-squared|||||19.8|7.0|0.00004
91662204|NCT03123471|183220075|SUPERIORITY||Difference in Response|22.1|||<|0.0001|TWO_SIDED|95.0|12.9|31.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4. The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.4|12.9|<0.0001
91662205|NCT03123471|183220075|SUPERIORITY||Difference in Response|20.1||||0.0003|TWO_SIDED|95.0|9.1|31.0|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.0|9.1|0.0003
91662206|NCT03123471|183220075|SUPERIORITY||Difference in Response|20.6||||0.0007|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||32.4|8.7|0.0007
91624861|NCT01375647|183142024|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.5|TWO_SIDED||||||t-test, 2 sided|||Sabin type 1 shedding||||0.5
91624862|NCT01375647|183142024|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.2|TWO_SIDED||||||t-test, 2 sided|||Sabin type 2 shedding||||0.2
91713884|NCT03286218|183319430|OTHER||LS Mean Difference|47.5|||||TWO_SIDED|90.0|39.5|55.5||||||High||55.5|39.5|
91713885|NCT03286218|183319430|OTHER||LS Mean Difference|58.4|||||TWO_SIDED|90.0|50.4|66.3||||||High||66.3|50.4|
91525130|NCT03324880|182925489|SUPERIORITY||Difference in LS Mean|-331.3|STANDARD_ERROR_OF_MEAN|132.56|=|0.007|TWO_SIDED|95.0|-594.6|-67.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in elemental calcium supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline elemental calcium supplement dose.|-67.9|-594.6|=0.007
91527760|NCT04250337|182930560|SUPERIORITY||LS Mean Difference (Final Values)|3.62|STANDARD_ERROR_OF_MEAN|2.386||0.131|TWO_SIDED|95.0|-1.08|8.32|||ANCOVA|||||8.32|-1.08|0.131
91624863|NCT01375647|183142024|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.1|TWO_SIDED||||||t-test, 2 sided|||Sabin type 3 shedding||||0.1
91624864|NCT01375647|183142026|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-7.3|4.5||||||Sabin type 1||4.5|-7.3|
91624865|NCT01375647|183142026|SUPERIORITY||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.2|0.9||||||Sabin type 2||0.9|-7.2|
91624866|NCT01375647|183142026|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.1||||||||6.1|-3.2|
91624867|NCT01375647|183142027|SUPERIORITY||Risk Difference (RD)|-33.7|||||TWO_SIDED|95.0|-40.7|-26.5||||||||-26.5|-40.7|
91624868|NCT01375647|183142027|SUPERIORITY||Risk Difference (RD)|-24.3|||||TWO_SIDED|95.0|-31.1|-17.5||||||||-17.5|-31.1|
91624869|NCT01375647|183142027|SUPERIORITY||Risk Difference (RD)|-45.6|||||TWO_SIDED|95.0|-52.6|-38.0||||||||-38.0|-52.6|
91624870|NCT01375647|183142028|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
91624871|NCT01375647|183142029|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91713886|NCT03286218|183319431|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91624872|NCT03788967|183142034|NON_INFERIORITY|The non-inferiority hypothesis test was a 1-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in overall response was greater than -12.5%, non-inferiority was declared.|Risk Difference|-3.3|||||TWO_SIDED|95.0|-9.7|3.2||||||||3.2|-9.7|
91624873|NCT03788967|183142036|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-11.3|1.9||||||||1.9|-11.3|
91662207|NCT03123471|183220076|SUPERIORITY||Difference in Response|14.6||||0.0025|TWO_SIDED|95.0|5.1|24.1|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.1|5.1|0.0025
91481689|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|-0.37|1.01||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 2 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.01|-0.37|
91481690|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.59|0.91||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.91|-0.59|
91481691|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.77|0.71||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.71|-0.77|
91481692|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.84|-0.36||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.36|-1.84|
91481693|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.81|-0.45||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.45|-1.81|
91481694|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.33|||||TWO_SIDED|95.0|-0.39|1.06||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.06|-0.39|
91525131|NCT03324880|182925492|SUPERIORITY||Difference in LS Mean|22.33|STANDARD_ERROR_OF_MEAN|3.271|<|0.001|TWO_SIDED|95.0|15.83|28.84||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|28.84|15.83|<0.001
91624874|NCT03788967|183142037|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-0.1|3.4||||||Statistical Analysis 1 (EOT)||3.4|-0.1|
91624875|NCT03788967|183142037|OTHER||Risk Difference|-0.6|||||TWO_SIDED|95.0|-4.0|2.8||||||Statistical Analysis 2 (TOC)||2.8|-4|
91662208|NCT03123471|183220076|SUPERIORITY||Difference in Response|21.3|||<|0.0001|TWO_SIDED|95.0|10.6|31.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.9|10.6|<0.0001
91713887|NCT03286218|183319431|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0781
91624876|NCT03788967|183142037|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-5.7|2.6||||||Statistical Analysis 3 (LFU)||2.6|-5.7|
91624877|NCT03788967|183142038|OTHER||Risk Difference|0.7|||||TWO_SIDED|95.0|-0.3|2.0||||||||2.0|-0.3|
91713888|NCT03286218|183319431|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0625|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0625
91624878|NCT03788967|183142039|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-3.8|0.6||||||||0.6|-3.8|
91624879|NCT03788967|183142040|OTHER||Risk Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.3||||||||2.3|-3.3|
91624880|NCT03788967|183142041|OTHER||Risk Difference|1.3|||||TWO_SIDED|95.0|-0.2|3.2||||||||3.2|-0.2|
91624881|NCT03788967|183142042|OTHER||Risk Difference|-2.2|||||TWO_SIDED|95.0|-5.3|0.8||||||||0.8|-5.3|
91624882|NCT03788967|183142043|OTHER||Risk Difference|-1.2|||||TWO_SIDED|95.0|-5.1|2.6||||||||2.6|-5.1|
91624883|NCT03788967|183142044|OTHER||Risk Difference|1.5|||||TWO_SIDED|95.0|-0.8|4.1||||||Statistical Analysis 1 (EOT)||4.1|-0.8|
91624884|NCT03788967|183142044|OTHER||Risk Difference|-4.5|||||TWO_SIDED|95.0|-10.8|1.9||||||Statistical Analysis 2 (TOC)||1.9|-10.8|
91624885|NCT03788967|183142044|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-7.9|5.0||||||||5|-7.9|
91624886|NCT03788967|183142048|OTHER||Risk Difference|-0.2|||||TWO_SIDED|95.0|-1.6|1.2||||||||1.2|-1.6|
91525132|NCT03324880|182925493|SUPERIORITY||Difference in LS Mean|785.5|STANDARD_ERROR_OF_MEAN|113.65|<|0.001|TWO_SIDED|95.0|559.6|1011.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|1011.3|559.6|<0.001
91662209|NCT03123471|183220076|SUPERIORITY||Difference in Response|22.0||||0.0003|TWO_SIDED|95.0|10.2|33.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||33.9|10.2|0.0003
91525133|NCT03324880|182925494|SUPERIORITY||Difference in LS Mean|56.43|STANDARD_ERROR_OF_MEAN|6.091|<|0.001|TWO_SIDED|95.0|44.33|68.53||1-sided p-value was reported.|MMRM|||Osteocalcin|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|68.53|44.33|<0.001
91525134|NCT03324880|182925494|SUPERIORITY||Difference in LS Mean|226.57|STANDARD_ERROR_OF_MEAN|33.425|<|0.001|TWO_SIDED|95.0|160.17|292.98||1-sided p-value was reported.|MMRM|||Procollagen 1 N-Terminal Propeptide|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|292.98|160.17|<0.001
91525135|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group Ratios (Serotype Ia)|0.96|||||TWO_SIDED|98.4|0.71|1.3||||||||1.3|0.71|
91624887|NCT03788967|183142049|OTHER||Risk Difference|-5.9|||||TWO_SIDED|95.0|-12.4|0.7||||||||0.7|-12.4|
91624888|NCT03788967|183142050|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-8.5|5.3||||||||5.3|-8.5|
91662210|NCT03123471|183220076|SUPERIORITY||Difference in Response|27.0|||<|0.0001|TWO_SIDED|95.0|15.1|38.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||38.9|15.1|<0.0001
91662211|NCT03123471|183220077|SUPERIORITY||Difference in LS Mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.17|-1.73|||ANCOVA|Treatment and stratification factor (Baseline ScPGA moderate or severe) as independent variables and baseline value as a covariate variable.||||-1.73|-4.17|<0.0001
91525136|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.81|||||TWO_SIDED|98.4|0.6|1.09||||||||1.09|0.6|
91624889|NCT03788967|183142054|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-13.5|4.1||||||Overall response for participants with AP||4.1|-13.5|
91624890|NCT03788967|183142054|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-11.0|7.7||||||Overall response in participants with cUTI||7.7|-11.0|
91624891|NCT03788967|183142055|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-7.2|9.9||||||||9.9|-7.2|
91624892|NCT03788967|183142055|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-20.6|3.8||||||≥65 to \<75 years||3.8|-20.6|
91624893|NCT03788967|183142055|OTHER||Risk Difference (RD)|-7.5|||||TWO_SIDED|95.0|-23.8|8.7||||||≥75 years||8.7|-23.8|
91624894|NCT03788967|183142056|OTHER||Risk Difference|-3.1|||||TWO_SIDED|95.0|-9.6|3.5||||||Central and Eastern Europe||3.5|-9.6|
91624895|NCT03788967|183142057|OTHER|||||||0.044|||||||Log Rank|||||||0.044
91624896|NCT03788967|183142058|OTHER|||||||0.736|||||||Log Rank|||||||0.736
91624897|NCT01316939|183142079|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.9|4.8||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.8|-12.9|
91624898|NCT01316939|183142079|SUPERIORITY_OR_OTHER||Percent difference of participants|-6.6|||||TWO_SIDED|95.0|-14.8|1.6||||||Placebo Vs GSK1605786A 500 mg BID at Week 28 and 52||1.6|-14.8|
91624899|NCT01316939|183142080|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.2|4.2||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.2|-12.2|
91624900|NCT01316939|183142080|SUPERIORITY_OR_OTHER||Percent difference of participants|-5.3|||||TWO_SIDED|95.0|-13.1|2.6||||||||2.6|-13.1|
91624901|NCT01281189|183142138|SUPERIORITY||LS Mean Difference (Final Values)|2.91||||0.8568|TWO_SIDED|95.0|-28.751|34.576|||ANCOVA|Includes treatment as a fixed effect and adjusts for baseline ALSFRS-R total score, duration from sx onset, site of onset, and use of riluzole.||||34.576|-28.751|0.8568
91624902|NCT01281189|183142139|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8375|TWO_SIDED|95.0|0.75|1.427|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole.|||Hazard Ratio (HR) (Dex/PBO)|1.427|0.750|0.8375
91624903|NCT01281189|183142140|SUPERIORITY||LS Mean Difference (Net)|0.076||||0.9019|TWO_SIDED|95.0|-1.128|1.28|||mixed-effects repeated-measures model|Mixed-effects repeated-measures model with treatment, visit, treatment-by visit interaction, baseline ALSFRS-R score, baseline-by-visit interaction|The mixed-effects repeated-measures model also adjusted for the following covariates: duration from symptom onset, site of onset, and use of riluzole.|||1.280|-1.128|0.9019
91624904|NCT01281189|183142141|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7715|TWO_SIDED|95.0|0.801|1.348|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.348|0.801|0.7715
91481695|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-0.46|0.93||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.93|-0.46|
91481696|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|-0.23|1.28||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.28|-0.23|
91481697|NCT03868124|182837006|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.19|1.29||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.29|-0.19|
91481698|NCT02742246|182837008|SUPERIORITY|||||||0.11||||||Group by Time interaction.|Regression, Linear|||||||0.11
91525137|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.84|||||TWO_SIDED|98.4|0.63|1.14||||||||1.14|0.63|
91481699|NCT02742246|182837009|SUPERIORITY|||||||0.14||||||Group by time interaction.|Regression, Linear|||||||0.14
91481700|NCT00054717|182837011|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481701|NCT00054717|182837012|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91481702|NCT00054717|182837013|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481703|NCT00054717|182837014|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481704|NCT00054717|182837015|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91525138|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|0.8|||||TWO_SIDED|98.4|0.49|1.29||||||||1.29|0.49|
91525139|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.05|||||TWO_SIDED|98.4|0.65|1.69||||||||1.69|0.65|
91662212|NCT01641380|183220081|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|||<|0.05|TWO_SIDED|95.0|-1.4|0.06|||Regression, Linear|||We also evaluated the difference between the number of days after the scheduled appointment patients returned.||.06|-1.4|<.05
91662213|NCT01641380|183220081|SUPERIORITY_OR_OTHER_LEGACY||Difference of proportions|0.417||||0.5187|TWO_SIDED|95.0|-13.3307|24.8818|||Chi-squared||Intervention 34/50; Control : 28/50|On time for 1st follow-up visit||24.8818|-13.3307|0.5187
91662214|NCT01641380|183220084|SUPERIORITY_OR_OTHER_LEGACY||[Proportion of Eligible Patients Enrolle|0.948|||||TWO_SIDED|||||||||||||
91481705|NCT00054717|182837016|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481706|NCT00054717|182837017|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481707|NCT00054717|182837018|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91662215|NCT04189848|183220130|OTHER|Treatment comparison|Treatment difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.6|||ANOVA|||Intensity of injection site pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||-3.6|-8.2|<0.0001
91481708|NCT00054717|182837019|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481709|NCT00054717|182837020|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481710|NCT00054717|182837021|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481711|NCT00054717|182837022|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481712|NCT00054717|182837023|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91525140|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.32|||||TWO_SIDED|98.4|0.85|2.06||||||||2.06|0.85|
91525141|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.17|||||TWO_SIDED|98.4|0.66|2.07||||||||2.07|0.66|
91525142|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.06|||||TWO_SIDED|98.4|0.63|1.78||||||||1.78|0.63|
91525143|NCT01412801|182925533|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|0.91|||||TWO_SIDED|98.4|0.52|1.58||||||||1.58|0.52|
91662216|NCT01588236|183220131|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0||||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|Mixed Models Analysis|||||||>0.05
91662217|NCT01588236|183220132|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo||||>0.05
91713889|NCT03286218|183319431|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0098|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0098
91624905|NCT01281189|183142142|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9033|TWO_SIDED|95.0|0.745|1.298|||Cox Proportional Hazards model|adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.298|0.745|0.9033
91624906|NCT01281189|183142143|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.772|TWO_SIDED|95.0|0.789|1.192|||Cox Proportional Hazards model||Hazard ratio (Dex/PBO)|||1.192|0.789|0.7720
91624907|NCT00527072|183142145|SUPERIORITY_OR_OTHER||Proportion|0.654||||0.05|TWO_SIDED|95.0|0.586|0.718|||exact binomial distribution|||null hypothesis H0: proportion = 0.30||0.718|0.586|0.05
91624908|NCT00527072|183142146|SUPERIORITY_OR_OTHER||proportion|0.791||||0.05|TWO_SIDED|95.0|0.73|0.844|||exact binomial distribution|||||0.844|0.730|0.05
91624909|NCT00527072|183142147|SUPERIORITY_OR_OTHER||proportion|0.646||||0.05|TWO_SIDED|95.0|0.577|0.711|||exact binomial distribution|||||0.711|0.577|0.05
91624910|NCT02657434|183142148|OTHER|Unstratified Analysis|Hazard Ratio, log|0.562|||<|0.0001|TWO_SIDED|95.0|0.471|0.671|||Log Rank|||||0.671|0.471|<0.0001
91624911|NCT02657434|183142149|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.866||||0.1559|TWO_SIDED|95.0|0.709|1.056|||Log Rank|||||1.056|0.709|0.1559
91624912|NCT02657434|183142149|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.864||||0.1546|TWO_SIDED|95.0|0.707|1.056|||Log Rank|||||1.056|0.707|0.1546
91662218|NCT01588236|183220133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between high dose vs placebo|Mixed Models Analysis|||||||<0.01
91481713|NCT00054717|182837024|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481714|NCT00054717|182837025|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481715|NCT00054717|182837026|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91525144|NCT05076149|182925567|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI)|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.5|0.9|||Mixed Models Repeated Measures|||||0.9|-0.5|< 0.0001
91525145|NCT05076149|182925568|SUPERIORITY||LS Mean difference|-2.8|||=|0.0034|TWO_SIDED|95.0|-4.7|-0.9|||Mixed Models Repeated Measures|||||-0.9|-4.7|=0.0034
91662219|NCT01588236|183220134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between low dose vs placebo|Mixed Models Analysis|||||||<0.05
91713890|NCT03286218|183319432|OTHER||LS Mean Difference|-29.9|||||TWO_SIDED|90.0|-34.0|-25.9||||||Alertness/drowsiness||-25.9|-34.0|
91713891|NCT03286218|183319432|OTHER||LS Mean Difference|-16.9|||||TWO_SIDED|90.0|-20.9|-12.8||||||Alertness/drowsiness||-12.8|-20.9|
91481716|NCT00054717|182837027|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
91481717|NCT00054717|182837028|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91481718|NCT00054717|182837029|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91481719|NCT00054717|182837030|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
91481720|NCT00054717|182837070|SUPERIORITY_OR_OTHER|||||||0.9894||95.0|||||Log Rank|||||||0.9894
91481721|NCT04218123|182837143|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||<|0.001|||||||ANOVA|||||||<0.001
91624913|NCT02657434|183142150|SUPERIORITY||Difference in event free rate|4.68||||0.2606|TWO_SIDED|95.0|-3.47|12.83|||z test|||||12.83|-3.47|0.2606
91525146|NCT05076149|182925569|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.16|||Generalized Estimated Equation Model|||||3.16|1.55|< 0.0001
91624914|NCT02657434|183142151|SUPERIORITY||Difference in Event Free Rate|5.12||||0.209|TWO_SIDED|95.0|-2.87|13.11|||Z-test|||||13.11|-2.87|0.2090
91624915|NCT02657434|183142152|SUPERIORITY||Difference in response rate|14.3||||0.0005|TWO_SIDED|95.0|5.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|5.9|0.0005
91624916|NCT02657434|183142153|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0024|TWO_SIDED|95.0|0.45|0.85|||Log Rank|||||0.85|0.45|0.0024
91624917|NCT00608881|183142163|SUPERIORITY_OR_OTHER||π hat|0.494|||||TWO_SIDED|95.0|0.454|0.534|||||π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.|In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.||0.534|0.454|
91624918|NCT00608881|183142164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.44|0.91||||||||0.91|-0.44|
91624919|NCT00608881|183142165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-1.4|1.58||||||||1.58|-1.40|
91624920|NCT00608881|183142166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44|||||TWO_SIDED|95.0|-6.68|3.79||||||||3.79|-6.68|
91624921|NCT00608881|183142167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-4.4|2.16||||||||2.16|-4.40|
91624922|NCT00608881|183142168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-1.48|1.39||||||||1.39|-1.48|
91624923|NCT00608881|183142169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.78|3.23||||||||3.23|-4.78|
91624924|NCT00608881|183142170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.32|2.14||||||||2.14|-1.32|
91624925|NCT00608881|183142171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.71|1.51||||||||1.51|-2.71|
91624926|NCT00608881|183142172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-2.28|2.87||||||||2.87|-2.28|
91624927|NCT00608881|183142173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.88|||||TWO_SIDED|95.0|0.31|7.44||||||||7.44|0.31|
91662220|NCT01030133|183220151|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|0.75||||||0.05
91713892|NCT03286218|183319432|OTHER||LS Mean Difference|-19.6|||||TWO_SIDED|90.0|-23.6|-15.5||||||Alertness/drowsiness||-15.5|-23.6|
91713893|NCT03286218|183319432|OTHER||LS Mean Difference|-24.8|||||TWO_SIDED|90.0|-28.8|-20.8||||||Alertness/drowsiness||-20.8|-28.8|
91713894|NCT03286218|183319432|OTHER||LS Mean Difference|-30.8|||||TWO_SIDED|90.0|-35.0|-26.5||||||Agitation/relaxation||-26.5|-35.0|
91624928|NCT00608881|183142174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|-1.1|3.18||||||||3.18|-1.10|
91624929|NCT00608881|183142175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.81|1.2||||||||1.20|0.81|
91624930|NCT00608881|183142176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.15||||||||1.15|0.75|
91624931|NCT00510484|183142178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91713895|NCT03286218|183319432|OTHER||LS Mean Difference|-19.5|||||TWO_SIDED|90.0|-23.7|-15.3||||||Agitation/relaxation||-15.3|-23.7|
91481722|NCT04218123|182837143|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
91481723|NCT04218123|182837143|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
91481724|NCT04218123|182837143|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||>|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||>0.05
91481725|NCT04218123|182837145|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.31|||||||ANOVA|||SF20 Physical Functioning||||=0.31
91624932|NCT00510484|183142179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91624933|NCT00510484|183142180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91624934|NCT00510484|183142181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91624935|NCT00510484|183142182|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91624936|NCT00510484|183142183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91713896|NCT03286218|183319432|OTHER||LS Mean Difference|-21.7|||||TWO_SIDED|90.0|-25.9|-17.5||||||Agitation/relaxation||-17.5|-25.9|
91481726|NCT04218123|182837145|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.633|||||||ANOVA|||SF20 Role Functioning||||0.633
91481727|NCT04218123|182837145|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.424|||||||ANOVA|||SF20 Mental Health||||0.424
91481728|NCT04218123|182837145|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.057|||||||ANOVA|||SF20 Social Functioning||||0.057
91481729|NCT04218123|182837145|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.296|||||||ANOVA|||SF20 Health Perceptions||||0.296
91481730|NCT04218123|182837145|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.872|||||||ANOVA|||SF20 Pain||||0.872
91481731|NCT04218123|182837146|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.538|||||||ANOVA|||||||=0.538
91481732|NCT04218123|182837147|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.686|||||||ANOVA|||||||=0.686
91481733|NCT04218123|182837148|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.167|||||||ANOVA|||||||=0.167
91481734|NCT04218123|182837149|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.8|||||||ANOVA|||||||=0.8
91481735|NCT04218123|182837150|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.425|||||||ANOVA|||||||=0.425
91481736|NCT04218123|182837151|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent.|||||=|0.054|||||||ANOVA|||||||=0.054
91481737|NCT01082640|182837154|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.134||0.459|TWO_SIDED|95.0|-0.37|0.17||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.17|-0.37|0.459
91624937|NCT00510484|183142184|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.013
91624938|NCT00510484|183142185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
91624939|NCT01181141|183142227|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-3.5|||||TWO_SIDED|95.0|-18.8|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-18.8|
91624940|NCT00118911|183142233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.631|STANDARD_DEVIATION|7.337|<|0.03|TWO_SIDED|95.0|-8.3|-0.963|||ANCOVA|We used multiple imputation.||Hypothesis was that CBT would be superior to RES||-0.963|-8.30|<.03
91624941|NCT00118911|183142234|SUPERIORITY_OR_OTHER||Slope|-0.12|STANDARD_DEVIATION|0.59|>|0.05|TWO_SIDED|95.0|-0.41|0.18|||Mixed Models Analysis||Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up|We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.||.18|-.41|>.05
91624942|NCT05014542|183142235|SUPERIORITY||Mean Difference (Final Values)|-42.8|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 15) - mean (WOMAC total of group C in Week 15)|WOMAC total analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
91713897|NCT03286218|183319432|OTHER||LS Mean Difference|-28.8|||||TWO_SIDED|90.0|-33.0|-24.5||||||Agitation/relaxation||-24.5|-33.0|
91791935|NCT00604214|183461570|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Unadjusted for multiple comparisons.|Fisher Exact|||||||0.154
91791936|NCT01879579|183461592|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
91525147|NCT05076149|182925570|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
91624943|NCT05014542|183142236|SUPERIORITY||Mean Difference (Final Values)|-8.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 15) - mean (WOMAC pain of group C at Week 15)|WOMAC pain analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at assessments.||||<.001
91624944|NCT05014542|183142237|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A at Week 15) - mean (WOMAC stiffness of group C at Week 15)|WOMAC stiffness between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
91624945|NCT05014542|183142238|SUPERIORITY||Mean Difference (Final Values)|-30.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 15) - mean (WOMAC functional disability of group C in Week 15)|WOMAC functional disability between groups at Week 15. The Shapiro-Wilk test (S-W) tests normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with a power of 95 % and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment (the mid-spread).||||<0.001
91624946|NCT05014542|183142239|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS of group A in Week 15) - mean (VAS of group C in Week 15)|Visual Analogue Scale (VAS) was compared between groups at Week 15, when the acupuncture of group A ended. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) presented the statistical dispersion of sample data at specified assessments.||||<0.001
91624947|NCT05014542|183142240|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ of group A in Week 15) - mean (KDSQ of group C in Week 15)|The Kidney Deficiency Syndrome Questionnaire (KDSQ) was compared between groups in Week 15. The Shapiro-Wilk test (S-W) tests the normality of data distribution. The comparability of groups regarding the null hypothesis of similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were used to analyse the statistical dispersion of specified sample data at specified assessment.||||<0.001
91624948|NCT05014542|183142241|SUPERIORITY||Mean Difference (Final Values)|-774.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG of A group in Week 15) - mean (DRUG of C group in Week 15)|In Week 15, DRUG was compared between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
91624949|NCT05014542|183142242|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.8493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group L knee in Week 15) - mean (C group L knee in Week 15)|Active extension of left (L) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.8493
91624950|NCT05014542|183142242|SUPERIORITY||Mean Difference (Final Values)|-0.107||||0.69654|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group R knee in Week 15) - mean (C group R knee in Week 15)|Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.69654
91624951|NCT05014542|183142243|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion L knee of group A at Week 15) - mean (active flexion L knee of group C at Week 15)|L knee flexion between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.490
91662221|NCT01097577|183220153|SUPERIORITY|||||||0.18|||||||ANOVA|||This study was designed to determine if pregabalin is an effective regimen for postoperative pain control following PRK. We hypothesized that there will be at least a 10% improvement in pain after PRK using a scheduled pregabalin dosing regimen compared to placebo. A power analysis was completed to determine the number of patients necessary.||||0.180
91662222|NCT01097577|183220154|SUPERIORITY|||||||0.207|||||||ANOVA|||||||0.207
91662223|NCT01097577|183220155|SUPERIORITY|||||||0.283|||||||ANOVA|||||||0.283
91662224|NCT01097577|183220156|SUPERIORITY|Question 1: Pain at its worst||||||0.223|||||||ANOVA|||||||0.223
91791937|NCT01879579|183461593|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Interval-censoring survival analysis|||||||0.007
91791938|NCT01879579|183461594|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.99
91525148|NCT02087501|182925571|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6|||||The CI is calculated based on Clopper-Pearson method|||11.6|0|
91525149|NCT02087501|182925571|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6||||||||11.6|0|
91624952|NCT05014542|183142243|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.517|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion R knee of group A at Week 15) - mean (active flexion R knee of group C at Week 15)|Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.517
91624953|NCT05014542|183142244|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.083|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A at Week 15) - mean (circumference of L upper leg of group C at Week 15)|Circumference of the left (L) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessment.||||0.083
91624954|NCT05014542|183142244|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A at Week 15) - mean (circumference of R upper leg of group C at Week 15)|Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments.||||0.084
91624955|NCT05014542|183142245|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.341|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knee of group A at Week 15) - mean (circumference of L knee of group C at Week 15)|Circumference of the left (L) knee in Week 15 was analysed between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.341
91624956|NCT05014542|183142245|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.317|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knee of group A at Week 15) - mean (circumference of R knee of group C at Week 15)|Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.317
91624957|NCT05014542|183142246|SUPERIORITY||Mean Difference (Final Values)|-33.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 24) -mean (WOMAC total of group C in Week 24)|WOMAC total was analysed in Week 24 between groups, nine weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tested the normality of the distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
91662225|NCT01097577|183220157|SUPERIORITY|||||||0.311|||||||ANOVA|||||||0.311
91662226|NCT01097577|183220158|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||Days to Heal, OD||||0.581
91713898|NCT00643201|183319438|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing: non-inferiority tested at 1-sided α=0.025 with margin of 1.8. Demonstration of non-inferiority using both relative risk (RR) (margin = 1.8) and risk difference (RD) (margin = 0.035) were required to achieve the primary objective.|Risk Ratio (RR)|0.839|||<|0.0001|TWO_SIDED|95.0|0.5965|1.1802||This is the first test in a sequential testing sequence. p-value calculated based on the Yanagawa-Tango-Hiejima test stratified by index event strata for non-inferiority. Tested at 1-sided α=0.025|Yanagawa-Tango-Hiejima|For a successful trial; rejection of the null hypotheses for both RR and RD was required.||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatal PE)/VTE-related death.||1.1802|0.5965|<0.0001
91713899|NCT00643201|183319438|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing; non-inferiority tested at 1-sided α=0.025. If non-inferiority demonstrated for both RR and RD, the primary objective was achieved.|Risk Difference (RD)|-0.0044|||<|0.0001|TWO_SIDED|95.0|-0.0128|0.004||Yanagawa-Tango-Hiejima test statistic for risk difference (RD).|Yanagawa-Tango-Hiejima|||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatalPE)/VTE-related death as measured by risk difference.||0.0040|-0.0128|<0.0001
91481738|NCT01082640|182837154|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.133||0.789|TWO_SIDED|95.0|-0.23|0.3||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.30|-0.23|0.789
91662227|NCT01097577|183220158|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||Days to Heal, OS||||0.307
91662228|NCT04493684|183220229|OTHER||Geometric Least Square Mean Ratio|2.462|||||TWO_SIDED|90.0|1.823|3.323|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-24). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.323|1.823|
91662229|NCT04493684|183220229|OTHER||Geometric Least Square Mean Ratio|1.381|||||TWO_SIDED|90.0|1.223|1.56|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-24). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.56|1.223|
91662230|NCT04493684|183220230|OTHER||Geometric Least Square Mean Ratio|2.103|||||TWO_SIDED|90.0|1.629|2.717|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-inf). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||2.717|1.629|
91624958|NCT05014542|183142247|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 24) - mean (WOMAC pain of group C at Week 24)|WOMAC pain was analysed between groups 9 weeks after acupuncture ended in Week 24. The Shapiro-Wilk test (S-W) tested the normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data (the mid-spread).||||<.001
91624959|NCT05014542|183142248|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A in Week 24) - mean (WOMAC stiffness of group C in Week 24)|WOMAC stiffness between groups A and C in Week 24, 9 weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tests the normality of distribution. Group comparability was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
91624960|NCT05014542|183142249|SUPERIORITY||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 24) - mean (WOMAC functional disability of group C in Week 24)|WOMAC functional disability at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests the normality of data. The comparability of groups regarding specified variables (to accept or reject the null hypothesis of comparability) was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
91624961|NCT05014542|183142250|SUPERIORITY||Mean Difference (Final Values)|-45.7|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 24 of group A) - mean (VAS in Week 24 of group C)|VAS was compared between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
91624962|NCT05014542|183142251|SUPERIORITY||Mean Difference (Final Values)|-11.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 24 of group A) - mean (KDSQ in Week 24 of group C)|KDSQ between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
91624963|NCT05014542|183142252|SUPERIORITY||Mean Difference (Final Values)|-581.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 24 of group A) - mean (DRUG in Week 24 of group C)|The DRUG between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
91662231|NCT04493684|183220230|OTHER||Geometric Least Square Mean Ratio|1.351|||||TWO_SIDED|90.0|1.22|1.497|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-inf). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.497|1.22|
91662232|NCT04493684|183220231|OTHER||Geometric Least Square Mean Ratio|2.307|||||TWO_SIDED|90.0|1.668|3.19|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter Cmax. Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.19|1.668|
91662233|NCT04493684|183220231|OTHER||Geometric Least Square Mean Ratio|1.372|||||TWO_SIDED|90.0|1.19|1.582|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter Cmax. Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.582|1.19|
91481739|NCT01082640|182837155|SUPERIORITY_OR_OTHER||LS mean difference|2.38|STANDARD_ERROR_OF_MEAN|1.687||0.162|TWO_SIDED|95.0|-0.97|5.73||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||5.73|-0.97|0.162
91525150|NCT02087501|182925572|OTHER||Sample proportion|100.0|||||TWO_SIDED|95.0|88.4|100.0|||||CI is calculated based on Clopper-Pearson method|||100|88.4|
91624964|NCT05014542|183142253|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext L of A group in Week 24) - mean (Act ext L of C group in Week 24)|Left (L) knee analysis between groups A and C in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability was tested with the Mann-Whitney U test, with 95% statistical power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessment.||||
91624965|NCT05014542|183142253|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext R knee of A group in Week 24) - mean (Act ext R knee of C group in Week 24)|Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment.||||
91662234|NCT00128219|183220312|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.044|TWO_SIDED|95.0|1.0|58.0||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||58|1|0.044
91624966|NCT05014542|183142254|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.953|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (L knee act flexion of group A in Week 24) - mean (L knee act flexion of group C in Week 24)|Left (L) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of specified sample data at a specified assessment (time-point).||||0.953
91624967|NCT05014542|183142254|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (R knee act flexion of group A in Week 24) - mean (R knee act flexion of group C in Week 24)|Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment.||||0.491
91624968|NCT05014542|183142255|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.261|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A in Week 24) - mean (circumference of L upper leg of group C in Week 24)|Circumference of the left (L) upper leg between groups in Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of a distribution. The comparability of groups regarding specified variables to accept or reject the hypothesis of groups comparability was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.261
91624969|NCT05014542|183142255|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.273|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A in Week 24) - mean (circumference of R upper leg of group C in Week 24)|Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.273
91624970|NCT05014542|183142256|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.445|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knees in Week 24 of group A) - mean (circumference of L knees in Week 24 of group C)|Circumference of left (L) knees in Week 24, in between-groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at an assessment.||||0.445
91624971|NCT05014542|183142256|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knees in Week 24 of group A) - mean (circumference of R knees in Week 24 of group C)|Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments.||||0.260
91624972|NCT05014542|183142257|SUPERIORITY||Mean Difference (Final Values)|-34.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 39) - mean (WOMAC total of group A in Week 0)|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total of group A in Week 39 (24 weeks after acupunctures ended) was compared with the pre-experimental baseline assessment by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. The null hypothesis at weeks 0 and 39 was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of the sample.||||<0.001
91624973|NCT05014542|183142257|SUPERIORITY||Mean Difference (Final Values)|-39.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total in Week 39 of group C) - mean (WOMAC total in Week 0 of group C).|WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample.||||< 0.001
91624974|NCT05014542|183142258|SUPERIORITY||Mean Difference (Final Values)|-6.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group A) - mean (WOMAC pain in Week 0 of group A)|The pain subscale of the WOMAC index of group A in Week 39 (24 weeks after acupunctures ended) was compared with baseline by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of sample data at assessments.||||<0.001
91624975|NCT05014542|183142258|SUPERIORITY||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group C) - mean (WOMAC pain in Week 0 of group C)|The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
91624976|NCT05014542|183142259|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group A) - mean (WOMAC stiffness in Week 0 of group A)|The stiffness subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
91662235|NCT00128219|183220337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.12|TWO_SIDED|95.0|0.917|2.34||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher's exact, with GBS III-TT arm in the numerator and Td arm in the denominator so \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||2.34|0.917|0.120
91662236|NCT00128219|183220338|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.089||95.0|-7.0|61.0||Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.|Binomial regression, log-linear link|The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.|Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.|The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.||61|-7|0.089
91624977|NCT05014542|183142259|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group C) - mean (WOMAC stiffness in Week 0 of group C)|The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
91662237|NCT00128219|183220339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.256|TWO_SIDED|95.0|0.18|1.45||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher's exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||1.45|0.18|0.256
91713900|NCT00643201|183319438|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.839||||0.3128|TWO_SIDED|95.0|0.5965|1.1802||Tested at 2-sided α=0.05 significance. Further inferential statistical testing halted due to failure to reject the null hypothesis of equivalence for VTE/VTE-related death.|Cochran-Mantel-Haenszel|Relative risk, CI, and p-value were calculated based on CMH test stratified by index event strata.||Hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing required demonstration of non-inferiority using both RR and RD plus demonstration of superiority for major bleeding.||1.1802|0.5965|0.3128
91713901|NCT00643201|183319439|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8151||||0.1554|TWO_SIDED|95.0|0.6146|1.0812||The test was stratified by index event strata using alpha=0.05 level of significance. Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.|Cochran-Mantel-Haenszel|Nominal p-value is reported.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0812|0.6146|0.1554
91791939|NCT01879579|183461595|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.78
91624978|NCT05014542|183142260|SUPERIORITY||Mean Difference (Final Values)|-25.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group A) - mean(WOMAC functional disability in Week 0 of group A)|The functional disability subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
91624979|NCT05014542|183142260|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group C) - mean (WOMAC functional disability in Week 0 of group C)|The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
91624980|NCT05014542|183142261|SUPERIORITY||Mean Difference (Final Values)|-41.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group A) - mean (VAS in Week 0 of group A)|VAS of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
91624981|NCT05014542|183142261|SUPERIORITY||Mean Difference (Final Values)|-31.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group C) - mean (VAS in Week 0 of group C)|VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||< 0.001
91481740|NCT01082640|182837155|SUPERIORITY_OR_OTHER||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|1.698||0.485|TWO_SIDED|95.0|-2.18|4.57||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||4.57|-2.18|0.485
91662238|NCT05710718|183220351|SUPERIORITY|||||||0.076|||||||paired T-test|No formal hypothesis test was planned for this pilot study. P-values are provided for exploratory purposes and are unadjusted for multiplicity.||||||0.076
91662239|NCT02591420|183220363|SUPERIORITY|||||||0.645|||||||Wilcoxon (Mann-Whitney)|||Pairwise Wilcoxon rank-sum test using 10,000 bootstrapped samples.||||.645
91662240|NCT02591420|183220363|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||.007
91662241|NCT02591420|183220363|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
91662242|NCT02591420|183220364|SUPERIORITY|||||||0.347|||||||Log Rank|||||||.347
91662243|NCT02591420|183220365|SUPERIORITY|||||||0.369|||||||Kruskal-Wallis|||||||.369
91662244|NCT02591420|183220366|SUPERIORITY|||||||0.645||||||p-value calculated using 10,000 bootstrap samples for day 7 data|Wilcoxon (Mann-Whitney)|||Comparison of groups 1 and 2 for data from day 7||||.645
91662245|NCT02591420|183220366|SUPERIORITY|||||||0.028||||||p-value calculated using 10,000 bootstrap samples for day 7 data|Wilcoxon (Mann-Whitney)|||Comparison between groups 1 and 3 for data from day 7||||0.028
91662246|NCT02591420|183220366|SUPERIORITY|||||||0.798||||||p-value calculated using 10,000 bootstrap samples for day 14 data|Wilcoxon (Mann-Whitney)|||Comparison of groups 1 and 2 for data from day 14||||0.798
91662247|NCT02591420|183220366|SUPERIORITY|||||||0.505||||||p-value calculated using 10,000 bootstrap samples for day 14 data|Wilcoxon (Mann-Whitney)|||Comparison of groups 1 and 3 for data from day 14||||.505
91662248|NCT02591420|183220366|SUPERIORITY||||||>|0.999||||||p-value calculated using 10,000 bootstrap samples for day 168 data|Wilcoxon (Mann-Whitney)|||Comparison of groups 1 and 2 at study day 168 (week 24)||||>.999
91662249|NCT02591420|183220366|SUPERIORITY|||||||0.497||||||p-value calculated using 10,000 bootstrap samples for day 168 data|Wilcoxon (Mann-Whitney)|||Comparison of groups 1 and 3 at study day 168||||0.497
91662250|NCT02591420|183220371|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
91662251|NCT02591420|183220371|SUPERIORITY|||||||0.39|||||||Barnard's test|||This test compares group 1 to groups 2 and 3 combined (1 vs. 2 \& 3)||||0.390
91662252|NCT02591420|183220372|SUPERIORITY|||||||0.694||||||Comparison of change in CD4+ T cells in Groups 1 and 2 from baseline to Nadir p-value calculated using 10,000 bootstrapped samples|Wilcoxon (Mann-Whitney)|||Comparison of change in CD4+ T cells in Groups 1 and 2 from baseline to Nadir||||0.694
91662253|NCT02591420|183220372|SUPERIORITY|||||||0.729|||||||Wilcoxon (Mann-Whitney)|Comparison of change in CD4+ T cells in Groups 1 and 3 from baseline to Nadir p-value calculated using 10,000 bootstrapped samples||Comparison of change in CD4+ T cells in Groups 1 and 3 from baseline to Nadir||||0.729
91662254|NCT02591420|183220372|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|Comparison of change in CD4+ T cells in Groups 1 and 2 from Nadir to Day 168 p-value calculated using 10,000 bootstrapped samples||Comparison of change in CD4+ T cells in Groups 1 and 2 from Nadir to Day 168||||0.694
91662255|NCT02591420|183220372|SUPERIORITY|||||||0.393|||||||Wilcoxon (Mann-Whitney)|Comparison of change in CD4+ T cells in Groups 1 and 3 from Nadir to Day 168 p-value calculated using 10,000 bootstrapped samples||Comparison of change in CD4+ T cells in Groups 1 and 3 from Nadir to Day 168||||0.393
91791940|NCT01879579|183461596|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.04
91481741|NCT01082640|182837156|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
91481742|NCT01082640|182837156|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
91662256|NCT02591420|183220372|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|Comparison of change in CD4+ T cells in Groups 1 and 2 from Baseline to Day 168 p-value calculated using 10,000 bootstrapped samples||Comparison of change in CD4+ T cells in Groups 1 and 2 from Baseline to Day 168||||>.999
91662257|NCT02591420|183220372|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|Comparison of change in CD4+ T cells in Groups 1 and 3 from Baseline to Day 168 p-value calculated using 10,000 bootstrapped samples||Comparison of change in CD4+ T cells in Groups 1 and 3 from Baseline to Day 168 p-value calculated using 10,000 bootstrapped samples||||>.999
91662258|NCT02591420|183220373|SUPERIORITY|||||||0.8629||||||Multiple comparisons are not required|Wilcoxon (Mann-Whitney)|||||||.8629
91662259|NCT05056376|183220419|NON_INFERIORITY|Noninferiority was defined a priori as the lower bound of the one-sided 95% CI for the risk difference being greater than or equal to -15%.|||||<|0.05|||||||Regression, Logistic|||The primary analysis was conducted in all randomized participants. Those who did not attend the 12-month study visit were classified as not achieving the primary composite outcome, providing a conservative estimate of intervention effectiveness. The risk difference was estimated using binomial regression.||||<0.05
91662260|NCT04742491|183220436|SUPERIORITY||Percentage|73.1||||0.8|TWO_SIDED|95.0|65.89|80.3|||Chi-squared||||The estimates and C.I. (In percentage) are derived using Chi-squared test.|80.30|65.89|0.80
91662261|NCT04742491|183220436|SUPERIORITY||Percentage|71.81||||0.8|TWO_SIDED|95.0|64.59|79.04|||Chi-squared||The estimates and C.I. (In percentage) are derived using Chi-squared test.|||79.04|64.59|0.80
91662262|NCT04742491|183220441|SUPERIORITY|||||||0.59|||||||Binomial Distribution|||||||0.59
91662263|NCT04742491|183220443|OTHER||Percentage|85.23||||0.6381|TWO_SIDED|95.0|79.54|90.93|||Binomial Distribution||The estimates and C.I. (In percentage) are derived using binomial distribution.|||90.93|79.54|0.6381
91662264|NCT04742491|183220443|OTHER||Percentage|87.1||||0.6381|TWO_SIDED|95.0|81.82|92.37|||Binomial Distribution||The estimates and C.I. (In percentage) are derived using binomial distribution.|||92.37|81.82|0.6381
91662265|NCT04742491|183220448|OTHER|The odds ratio was calculated with the deferred intervention arm as the reference group.|Odds Ratio (OR)|0.96||||0.91|TWO_SIDED|95.0|0.45|2.03|||Regression, Logistic|||Calculating the odds of Gonorrhea.||2.03|0.45|0.91
91662266|NCT04742491|183220448|OTHER|The odds ratio was calculated with the deferred intervention arm as the reference group.|Odds Ratio (OR)|0.96||||0.91|TWO_SIDED|95.0|0.45|2.03|||Regression, Logistic|||Calculating the odds of Chlamydia Trachomatis.||2.03|0.45|0.91
91791941|NCT01879579|183461597|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.13
91481743|NCT01082640|182837156|SUPERIORITY_OR_OTHER|||||||0.062|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||0.062
91624982|NCT05014542|183142262|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group A) - mean (KDSQ in Week 0 of group A)|KDSQ of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
91481744|NCT03577171|182837168|OTHER||LS Mean Difference|-1.154||||0.0077|TWO_SIDED|95.0|-1.986|-0.322|||Repeated measures analysis|||Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12||-0.322|-1.986|0.0077
91624983|NCT05014542|183142262|SUPERIORITY||Mean Difference (Final Values)|-11.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group C) - mean (KDSQ in Week 0 of group C)|KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
91624984|NCT05014542|183142263|SUPERIORITY||Mean Difference (Final Values)|-361.4||||0.204|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group A) - mean (DRUG in Week 0 of group A)|The DRUG of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.204
91662267|NCT04742491|183220448|OTHER|The odds ratio was calculated with the deferred intervention arm as the reference group.|Odds Ratio (OR)|0.76||||0.32|TWO_SIDED|95.0|0.45|1.3|||Regression, Logistic|||Calculating the odds of a syphilis positive/reactive test.||1.30|0.45|0.32
91662268|NCT04742491|183220449|SUPERIORITY||Odds Ratio (OR)|1.45||||0.69|TWO_SIDED|95.0|0.24|8.81|||Regression, Logistic|||Logistic regression results of Hepatitis C infection at baseline.||8.81|0.24|0.69
91662269|NCT04742491|183220456|SUPERIORITY||Incidence Rate|1.92|||||TWO_SIDED|95.0|0.72|5.12||||||Poisson regression models with person time were used to estimate HIV incidence for the immediate intervention arm.||5.12|0.72|
91662270|NCT04742491|183220456|SUPERIORITY||Incidence Rate|0.48|||||TWO_SIDED|95.0|0.07|3.39||||||Poisson regression models with person time was used to estimate HIV incidence for the deferred intervention arm.||3.39|0.07|
91662271|NCT04742491|183220457|SUPERIORITY||Incidence Rate|31.47||||0.93|TWO_SIDED|95.0|23.86|41.51|||Poisson Regression||Incidence Rate of any STI Incidence per Person-Years using Poisson Regression was calculated.|Incidence rate of STIs for immediate intervention arm||41.51|23.86|0.93
91662272|NCT04742491|183220457|SUPERIORITY||Incidence Rate|32.01||||0.93|TWO_SIDED|95.0|23.92|42.83|||Poisson Regression||Incidence Rate of any STI Incidence per Person-Years using Poisson Regression was calculated.|Incidence rate of STIs for deferred intervention arm||42.83|23.92|0.93
91662273|NCT04742491|183220457|SUPERIORITY||Poisson Regression|31.74||||0.93|TWO_SIDED|95.0|25.96|38.8|||Poisson Regression||Incidence Rate of any STI Incidence per Person-Years using Poisson Regression was calculated.|Poisson regression was used to compare the incidence rate of STIs by arm.||38.80|25.96|0.93
91662274|NCT04742491|183220458|SUPERIORITY||Odds Ratio (OR)|2.44||||0.08|TWO_SIDED|95.0|0.89|6.69|||Regression, Logistic||Estimates are for age group 26+ compared to 25 or less.|Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section presents p-values and odds ratios for age.||6.69|0.89|0.08
91662275|NCT04742491|183220458|SUPERIORITY||Odds Ratio (OR)|0.38||||0.37|TWO_SIDED|95.0|0.05|3.16|||Regression, Logistic||Estimates are for comparison of highest level of education primary school vs. college.|Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for education.||3.16|0.05|0.37
91791942|NCT01879579|183461602|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Generalized estimating equation modeling|||||||0.008
91481745|NCT03577171|182837168|OTHER||LS Mean Difference|-1.141||||0.0084|TWO_SIDED|95.0|-1.973|-0.309|||Repeated measures analysis|||Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24||-0.309|-1.973|0.0084
91481746|NCT03190369|182837200|SUPERIORITY||LS Mean difference|0.125|STANDARD_ERROR_OF_MEAN|0.137||0.361|TWO_SIDED|95.0|-0.144|0.395||Threshold for significance at 0.05 level.|ANCOVA|Least-square (LS) means, standard errors (SE) were analyzed from repeated measures ANCOVA.||Least-square (LS) means, standard errors (SE) were analyzed from repeated measures analysis of covariance (ANCOVA). The model included treatment groups (Hylan G-F 20 and placebo), site, visit and visit by treatment interaction, as well as the baseline WOMAC A1 score as a covariate).||0.395|-0.144|0.3610
91525151|NCT02087501|182925573|OTHER||Sample proportion|80.0|||||TWO_SIDED|95.0|61.0|92.0||||||||92|61|
91624985|NCT05014542|183142263|SUPERIORITY||Mean Difference (Final Values)|-305.4||||0.134|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group C) - mean (DRUG in Week 0 of group C)|The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.134
91791943|NCT01879579|183461603|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.003
91527761|NCT04250337|182930561|SUPERIORITY||LS Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.145|<|0.001|TWO_SIDED|95.0|-6.26|-1.74|||Mixed Models Analysis|||||-1.74|-6.26|<0.001
91662276|NCT04742491|183220458|SUPERIORITY||Odds Ratio (OR)|0.41||||0.04|TWO_SIDED|95.0|0.17|0.98|||Regression, Logistic||Estimates are for comparison of highest level of education high school vs. college|Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for education.||0.98|0.17|0.04
91713902|NCT00643201|183319440|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7994||||0.1848|TWO_SIDED|95.0|0.5737|1.1137||The test was stratified by index event strata using alpha=0.05 level of significance. . Nominal p-value is reported.|Cochran-Mantel-Haenszel|Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1137|0.5737|0.1848
91713903|NCT00643201|183319441|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6236||||0.0011|TWO_SIDED|95.0|0.4682|0.8306||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.8306|0.4682|0.0011
91713904|NCT00643201|183319442|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5532|||<|0.0001|TWO_SIDED|95.0|0.4658|0.6569||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6569|0.4658|<0.0001
91713905|NCT00643201|183319443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6347|||||TWO_SIDED|95.0|0.3735|1.0787|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0787|0.3735|
91481747|NCT01289782|182837207|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|29.3|||<|0.001|TWO_SIDED|95.0|20.1|38.6|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||38.6|20.1|<0.001
91481748|NCT01289782|182837208|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|28.9|||<|0.001|TWO_SIDED|95.0|19.6|38.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVRW72 between the treatment groups.||38.2|19.6|<0.001
91481749|NCT01289782|182837209|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|30.1|||<|0.001|TWO_SIDED|95.0|20.8|39.3|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||39.3|20.8|<0.001
91481750|NCT01289782|182837210|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|25.8|||<|0.001|TWO_SIDED|95.0|16.8|34.8|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR4 between the treatment groups.||34.8|16.8|<0.001
91481751|NCT01289782|182837237|SUPERIORITY_OR_OTHER||Mean differences|-20.679|STANDARD_ERROR_OF_MEAN|6.0979|<|0.001|TWO_SIDED|95.0|-32.6399|-8.7181|||Piecewise-Linear Model Approach|||Fatigue Severity Score AUC60||-8.7181|-32.6399|<0.001
91481752|NCT01289782|182837237|SUPERIORITY_OR_OTHER||Mean differences|-23.8|STANDARD_ERROR_OF_MEAN|7.2358|<|0.001|TWO_SIDED|95.0|-37.9931|-9.6064|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-9.6064|-37.9931|<0.001
91662277|NCT04742491|183220458|SUPERIORITY||Odds Ratio (OR)|2.21||||0.07|TWO_SIDED|95.0|0.98|5.28|||Regression, Logistic||Estimates are for comparison of physical violence yes vs. no|Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304). This section provides p-values and odds ratio estimates for physical violence.||5.28|0.98|0.07
91713906|NCT00643201|183319444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0935|||||TWO_SIDED|95.0|0.6363|1.8793|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.8793|0.6363|
91713907|NCT00643201|183319445|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7521|||||TWO_SIDED|95.0|0.356|1.5889|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.5889|0.3560|
91713908|NCT00643201|183319446|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6539|||||TWO_SIDED|95.0|0.3419|1.2508|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.2508|0.3419|
91481753|NCT01289782|182837238|SUPERIORITY_OR_OTHER||Mean differences|-230.464|STANDARD_ERROR_OF_MEAN|105.9203||0.03|TWO_SIDED|95.0|-438.2662|-22.6626|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-22.6626|-438.2662|0.030
91481754|NCT01289782|182837238|SUPERIORITY_OR_OTHER||Mean differences|-248.208|STANDARD_ERROR_OF_MEAN|124.6753||0.047|TWO_SIDED|95.0|-492.8253|-3.5916|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-3.5916|-492.8253|0.047
91481755|NCT01289782|182837239|SUPERIORITY_OR_OTHER||Mean Differences|-278.06|STANDARD_ERROR_OF_MEAN|105.6088||0.009|TWO_SIDED|95.0|-485.2529|-70.8668|||Piecewise linear model|||Impairment in Daily Activities AUC60||-70.8668|-485.2529|0.009
91481756|NCT01289782|182837239|SUPERIORITY_OR_OTHER||Mean differences|-307.722|STANDARD_ERROR_OF_MEAN|124.1956||0.013|TWO_SIDED|95.0|-551.4006|-64.0429|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-64.0429|-551.4006|0.013
91481757|NCT01289782|182837240|SUPERIORITY_OR_OTHER||Mean differences|46.399|STANDARD_ERROR_OF_MEAN|99.7966||0.642|TWO_SIDED|95.0|-149.6374|242.436|||Piecewise linear model|||Time Missed from Work AUC60||242.4360|-149.6374|0.642
91481758|NCT01289782|182837240|SUPERIORITY_OR_OTHER||Mean differences|57.164|STANDARD_ERROR_OF_MEAN|115.1548||0.62|TWO_SIDED|95.0|-169.1143|283.4414|||Piecewise Linear Model|||Time Missed from Work AUC72||283.4414|-169.1143|0.620
91481759|NCT00048061|182837295|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.615||||0.045|TWO_SIDED|95.0|0.013|1.216|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.|||1.216|0.013|0.045
91527762|NCT04250337|182930562|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.407||0.571|TWO_SIDED|95.0|-3.58|1.98|||ANCOVA|||||1.98|-3.58|0.571
91481760|NCT00048061|182837295|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.297||||0.338|TWO_SIDED|95.0|-0.312|0.906|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control|||0.906|-0.312|0.338
91662278|NCT04742491|183220458|SUPERIORITY||Odds Ratio (OR)|999.99||||0.97|TWO_SIDED|95.0|0.001|999.99|||Regression, Logistic||Estimates are for comparison of physical violence prefer not answer vs. no (not estimable)|Multivariable logistic regression modeled PrEP uptake using age, highest level of education, and physical violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 190 of 304).This section provides p-values and odds ratio estimates for physical violence.||999.99|0.001|0.97
91662279|NCT04742491|183220459|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8|TWO_SIDED|95.0|0.64|1.4|||GEE||Estimates are for group emotional violence yes vs. no.|Multivariable GEE modeling the probability of high PrEP adherence with predictor emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to visits with complete data (1518 of 1533 visits). This section provides p-values and odds ratio estimates for emotional violence.||1.40|0.64|0.8
91662280|NCT04742491|183220459|SUPERIORITY||Odds Ratio (OR)|2.57||||0.004|TWO_SIDED|95.0|1.35|4.92|||GEE||Estimates are for group emotional violence prefer not to answer vs. no.|Multivariable GEE modeling the probability of high PrEP adherence with predictor emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to visits with complete data (1518 of 1533 visits). This section provides p-values and odds ratio estimates for emotional violence.||4.92|1.35|0.004
91662281|NCT04742491|183220460|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.08|TWO_SIDED|95.0|-0.39|0.02|||Regression, Linear||Estimates are for highest level of education primary school vs. college.|Multivariable linear regression of PrEP persistence with predictors highest level of education and emotional violence adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for highest level of education.||0.02|-0.39|0.08
91662282|NCT04742491|183220460|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.06|TWO_SIDED|95.0|-0.22|0.003|||Regression, Linear||Estimates are for highest level of education high school vs. college.|Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for the highest level of education.||0.003|-0.22|0.06
91662283|NCT04742491|183220460|SUPERIORITY||Mean Difference (Final Values)|-0.016||||0.76|TWO_SIDED|95.0|-0.12|0.09|||Regression, Linear|||Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for emotional violence.|Estimates are for group emotional violence yes vs. no.|0.09|-0.12|0.76
91662284|NCT04742491|183220460|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.09|TWO_SIDED|95.0|-0.06|0.78|||Regression, Linear|||Multivariable linear regression of PrEP persistence with predictors highest level of education, and emotional violence, adjusting for site. Only predictors significant in univariable analysis were included-study arm was excluded due to lack of significance. Analysis was limited to participants with complete data (N = 252 of 268). This section provides p-values and odds ratio estimates for emotional violence.|Estimates are for group emotional violence prefer not to answer vs. no.|0.78|-0.06|0.09
91662285|NCT04742491|183220461|OTHER||||||||||||||||||"Multivariable logistic regression was pre-specified but not performed because there were too few participants with the outcome absent (i.e., very few 'No' responses), leading to separation and non-estimable/unstable adjusted effect estimates. Results for Yes responses are presented descriptively (counts and percentages) by arm in the outcome measure data table."|||
91662286|NCT03317899|183220462|NON_INFERIORITY|Weibull accelerated failure time model; adjusted for disease type and stem cell collection days; non-inferiority declared if 90% CI upper bound for acceleration factor \< 1.133 (≤13.3% increase in discharge readiness time); one-sided α = 0.05; sample size for \~80% power; O'Brien-Fleming futility boundary applied.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91662287|NCT03317899|183220463|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91662288|NCT03317899|183220464|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
91662289|NCT03317899|183220465|OTHER|||||||0.337|||||||Chi-squared|||||||0.337
91662290|NCT03317899|183220467|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91662291|NCT03317899|183220468|OTHER|||||||0.936|||||||Wilcoxon (Mann-Whitney)|||||||0.936
91662292|NCT03317899|183220469|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91662293|NCT03317899|183220470|OTHER|||||||0.089|||||||Chi-squared|||||||0.089
91662294|NCT03317899|183220471|OTHER|||||||0.645|||||||Chi-squared|||||||0.645
91713909|NCT00643201|183319447|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7934|||||TWO_SIDED|95.0|0.5287|1.1906|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1906|0.5287|
91481761|NCT00048061|182837295|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.0||||0.001|TWO_SIDED|95.0|0.395|1.605|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.|||1.605|0.395|0.001
91662295|NCT00446966|183220472|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91624986|NCT05014542|183142264|SUPERIORITY||Mean Difference (Final Values)|-7.53|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (Lequesne index in Week 24 of A group) - mean (Lequesne index in Week 24 of C group)|The Lequesne index in Week 24 compared two confirmed comparable groups (at baseline), 9 weeks after acupuncture treatment in group A ended, while the C group was still a control. The Shapiro-Wilk test (S-W) tests normality distribution. The between-group comparability test at Week 24 was provided to accept or reject the null hypothesis by the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion.||||< 0.001
91481762|NCT01262352|182837311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.069||||0.0004|TWO_SIDED|95.0|-2.98|-1.15|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a mixed effect model. The model included the absolute change from the baseline in each period as the dependent variable, sequence, treatment, and period as fixed effects, study baseline LCI as the covariate, and subject nested within sequence as the random effect.||-1.15|-2.98|0.0004
91481763|NCT01262352|182837312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.007||||0.0117|TWO_SIDED|95.0|1.8|12.21||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for this efficacy variable was performed in a similar way as the analysis for the primary efficacy variable.||12.21|1.80|0.0117
91481764|NCT01262352|182837313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.848|||<|0.0001|TWO_SIDED|95.0|-53.54|-38.16||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for change from baseline in average sweat chloride was similar to the analysis of the primary efficacy variable.||-38.16|-53.54|<0.0001
91481765|NCT01262352|182837314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.991||||0.3796|TWO_SIDED|95.0|-5.4|13.39||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||The raw scores in CFQ-R were summarized into different domains of health (12 domains for adolescents and adults 14 years of age and older, 8 domains for children ages 12 and 13 years, 8 domains for children ages 6 to 11 years, and 11 domains for parents/caregivers). Each domain was analyzed in a similar way as for the primary efficacy variable. The primary analytical focus was the respiratory health domain which was analyzed by combining all self-response questionnaire versions.||13.39|-5.40|0.3796
91481766|NCT02925793|182837330|SUPERIORITY||Mean Difference|-2.9||||0.0106|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1% and 5% groups (statistical analysis 2) produced the same estimated value (-2.9)||||0.0106
91481767|NCT02925793|182837330|SUPERIORITY||Mean Difference|-2.9||||0.0483|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1%(statistical analysis 1) and 5% groups produced the same estimated value (-2.9)||||0.0483
91481768|NCT03475875|182837359|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-7.7|-0.9|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||-0.9|-7.7|
91525152|NCT00094328|182925583|OTHER|One sample t-test|Mean Difference (Final Values)|-1.62||||0.278|TWO_SIDED|95.0|-4.72|1.48|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (cm/year) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.48|-4.72|0.278
91527763|NCT04250337|182930563|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.127||0.882|TWO_SIDED|95.0|-2.4|2.06|||ANCOVA|||||2.06|-2.40|0.882
91624987|NCT04446299|183142332|NON_INFERIORITY|The predetermined non-inferiority margin was 10%.|Risk Difference (RD)|3.42|||<|0.001|TWO_SIDED|95.0|-1.68|8.52|||Mantel Haenszel|||||8.52|-1.68|<0.001
91624988|NCT03819478|183142335|SUPERIORITY|||||||0.488|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4880
91662296|NCT03913377|183220477|EQUIVALENCE|A statistically significant difference in NIBUT/NIKBUT between Test lens and Spectacles was concluded if the upper confidence limit of the 95% CI is below zero or the lower limit is above zero.|LS Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|0.678|||TWO_SIDED|95.0|-4.14|-1.44|||Mixed Model Analysis|Kenward and Roger method was used for denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|The null and alternative hypotheses for testing significant difference between Test lens and Spectacles among habitual lens users with respect to NIBUT/NIKBUT.||-1.44|-4.14|
91624989|NCT03819478|183142335|SUPERIORITY|||||||0.1683|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1683
91624990|NCT03819478|183142336|SUPERIORITY|||||||0.7636|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.7636
91624991|NCT03819478|183142337|SUPERIORITY|||||||0.1584|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1584
91624992|NCT03819478|183142337|SUPERIORITY|||||||0.1623|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1623
91624993|NCT03819478|183142338|SUPERIORITY|||||||0.035|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0350
91624994|NCT03819478|183142339|SUPERIORITY|||||||0.2422|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.2422
91624995|NCT03819478|183142339|SUPERIORITY|||||||0.5082|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5082
91624996|NCT03819478|183142340|SUPERIORITY|||||||0.5119|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5119
91624997|NCT03819478|183142340|SUPERIORITY|||||||0.4902|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4902
91624998|NCT03819478|183142341|SUPERIORITY|||||||0.85|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.8500
91624999|NCT03819478|183142342|SUPERIORITY|||||||0.3685|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.3685
91625000|NCT03819478|183142342|SUPERIORITY|||||||0.0894|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0894
91662297|NCT03913377|183220478|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|85.59|STANDARD_ERROR_OF_MEAN|1.038|||TWO_SIDED|95.0|43.2|97.89|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||97.89|43.2|
91481769|NCT03475875|182837360|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|-4.7|1.0|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||1.0|-4.7|
91481770|NCT02431247|182837406|NON_INFERIORITY|One-sided p-value for non-inferiority of Test versus Control arm. The non-|Difference in percentage|2.7|||<|0.001|TWO_SIDED|95.0|-1.6|7.1||inferiority margin is 10%.|Mantel Haenszel|||||7.1|-1.6|< 0.001
91481771|NCT02431247|182837409|OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.063|=|0.437|TWO_SIDED|95.0|-0.171|0.074|||ANCOVA|||||0.074|-0.171|= 0.437
91481772|NCT02431247|182837410|OTHER||LS mean difference|18.48|STANDARD_ERROR_OF_MEAN|14.808|=|0.213|TWO_SIDED|95.0|-10.595|47.55|||ANCOVA|||||47.550|-10.595|= 0.213
91481773|NCT02431247|182837411|OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.008|<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||ANCOVA|||||-0.02|-0.05|< 0.001
91625001|NCT03819478|183142343|SUPERIORITY|||||||0.5334|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5334
91625002|NCT03819478|183142344|SUPERIORITY|||||||0.1573|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1573
91625003|NCT00091962|183142350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED|95.0||||repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.|Mixed Models Analysis|||||||0.001
91625004|NCT01488409|183142353|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||||||0.97
91625005|NCT01488409|183142354|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
91625006|NCT01488409|183142355|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
91625007|NCT01488409|183142356|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
91625008|NCT01488409|183142357|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||||||0.007
91625009|NCT03258632|183142379|SUPERIORITY||Odds Ratio (OR)|1.17|||<|0.05|TWO_SIDED|95.0|0.73|1.9|||Mixed Models Analysis|||||1.90|0.73|<.05
91625010|NCT03162458|183142381|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91625011|NCT03162458|183142382|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
91625012|NCT03162458|183142383|SUPERIORITY|||||||0.055|||||||Log Rank|||||||0.055
91625013|NCT03162458|183142384|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||||||0.051
91625014|NCT03162458|183142385|SUPERIORITY|||||||0.19|||||||ANOVA|||Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)||||0.19
91625015|NCT03162458|183142385|SUPERIORITY|||||||0.44|||||||ANOVA|||Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)||||0.44
91625016|NCT03162458|183142386|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
91625017|NCT03162458|183142387|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
91625018|NCT03162458|183142388|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91625019|NCT03162458|183142389|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
91625020|NCT03162458|183142390|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91625021|NCT01183312|183142393|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||wilcoxon signed rank (paired)|||||||0.77
91625022|NCT01183312|183142394|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.51
91625023|NCT01183312|183142395|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.32
91625024|NCT01183312|183142396|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.56
91625025|NCT01183312|183142397|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.14
91625026|NCT01183312|183142398|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.89
91625027|NCT01183312|183142399|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.13
91625028|NCT04491240|183142409|SUPERIORITY||Mean Difference (Net)|73.29|STANDARD_DEVIATION|82.91404||0.020875|TWO_SIDED|95.0|13.97687|132.6031|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||132.6031|13.97687|0.020875
91625029|NCT04491240|183142409|SUPERIORITY||Mean Difference (Net)|69.56|STANDARD_DEVIATION|45.67648||0.000953|TWO_SIDED|95.0|36.88502|102.235|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||102.2350|36.88502|0.000953
91625030|NCT04491240|183142409|SUPERIORITY||Mean Difference (Net)|53.21|STANDARD_DEVIATION|39.85531||0.002233|TWO_SIDED|95.0|24.69923|81.72077|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||81.72077|24.69923|0.002233
91662298|NCT03913377|183220478|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|84.17|STANDARD_ERROR_OF_MEAN|0.871|||TWO_SIDED|95.0|48.67|96.75|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||96.75|48.67|
91625031|NCT04491240|183142410|SUPERIORITY||Mean Difference (Net)|331.52|STANDARD_DEVIATION|315.823||0.008948|TWO_SIDED|95.0|105.5938|557.4462|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||557.4462|105.5938|0.008948
91625032|NCT04491240|183142410|SUPERIORITY||Mean Difference (Net)|366.63|STANDARD_DEVIATION|414.9726||0.020921|TWO_SIDED|95.0|69.77651|663.4835|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||663.4835|69.77651|0.020921
91625033|NCT04491240|183142410|SUPERIORITY||Mean Difference (Net)|239.2|STANDARD_DEVIATION|204.0934||0.004873|TWO_SIDED|95.0|93.20037|385.1996|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||385.1996|93.20037|0.004873
91662299|NCT03913377|183220479|OTHER|Estimated 95% confidence intervals for the point estimates of test.|Mean|0.52|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|0.4|0.65|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimate was calculated for Test.|0.65|0.40|
91481774|NCT02431247|182837412|OTHER||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.786|<|0.001|TWO_SIDED|95.0|1.57|4.66|||ANCOVA|||||4.66|1.57|< 0.001
91481775|NCT02431247|182837413|OTHER||LS mean difference|6.04|STANDARD_ERROR_OF_MEAN|1.126|<|0.001|TWO_SIDED|95.0|3.83|8.25|||ANCOVA|||||8.25|3.83|< 0.001
91481776|NCT02431247|182837414|OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.747|=|0.001|TWO_SIDED|95.0|0.93|3.87|||ANCOVA|||||3.87|0.93|= 0.001
91481777|NCT02431247|182837416|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
91481778|NCT02431247|182837417|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
91481779|NCT02431247|182837418|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
91481780|NCT02431247|182837419|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
91481781|NCT02431247|182837420|OTHER||||||=|0.147|||||||Wilcoxon rank sum test|||||||= 0.147
91481782|NCT02431247|182837425|OTHER||LS mean difference|1.95|STANDARD_ERROR_OF_MEAN|0.368|<|0.001|TWO_SIDED|95.0|1.227|2.678|||ANCOVA|||Hip region BMD (Week 24)||2.678|1.227|< 0.001
91662300|NCT03913377|183220479|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean|0.13|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|95.0|-0.19|0.44|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimates were calculated for Control.|0.44|-0.19|
91662301|NCT03913377|183220480|OTHER|Estimated 95% confidence intervals for the point estimates of Test.|Mean Proportion|30.7|STANDARD_ERROR_OF_MEAN|19.87|||TWO_SIDED|95.0|6.5|73.8|||Mixed Model Analysis||Point estimates were calculated for Test|||73.8|6.5|
91662302|NCT03913377|183220480|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean Proportion|27.9|STANDARD_ERROR_OF_MEAN|18.17|||TWO_SIDED|95.0|6.1|69.8|||Mixed Model Analysis||Point estimates were calculated for Control.|||69.8|6.1|
91481783|NCT02431247|182837425|OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|1.934|3.791|||ANCOVA|||Hip region BMD (Week 48)||3.791|1.934|< 0.001
91481784|NCT02431247|182837425|OTHER||LS mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|1.259|2.919|||ANCOVA|||Spine region BMD (Week 24)||2.919|1.259|< 0.001
91481785|NCT02431247|182837425|OTHER||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.588|=|0.004|TWO_SIDED|95.0|0.539|2.858|||ANCOVA|||Spine region BMD (Week 48)||2.858|0.539|= 0.004
91481786|NCT00591578|182837474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||<|0.001|TWO_SIDED|95.0|-5.59|-1.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-1.69|-5.59|<0.001
91481787|NCT00591578|182837474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|||<|0.001|TWO_SIDED|95.0|-6.01|-2.06||Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-2.06|-6.01|<0.001
91481788|NCT00591578|182837475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27||||0.015|TWO_SIDED|95.0|-5.9|-0.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.63|-5.90|0.015
91481789|NCT00591578|182837475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.34|||<|0.001|TWO_SIDED|95.0|-8.0|-2.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.68|-8.00|<0.001
91481790|NCT00591578|182837476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.44|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.88|-3.44|<0.001
91481791|NCT00591578|182837476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.001|TWO_SIDED|95.0|-3.99|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.40|-3.99|<0.001
91481792|NCT00591578|182837477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.001|TWO_SIDED|95.0|-4.06|-0.98||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.98|-4.06|0.001
91481793|NCT00591578|182837477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|||<|0.001|TWO_SIDED|95.0|-4.32|-1.21||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.21|-4.32|<0.001
91481794|NCT00591578|182837478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||<|0.001|TWO_SIDED|95.0|-5.53|-1.44||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.44|-5.53|<0.001
91481795|NCT00591578|182837478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.96|-1.83||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.83|-5.96|<0.001
91481796|NCT00591578|182837479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.002|TWO_SIDED|95.0|-3.54|-0.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.79|-3.54|0.002
91481797|NCT00591578|182837479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67|||<|0.001|TWO_SIDED|95.0|-4.06|-1.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.28|-4.06|<0.001
91481798|NCT00591578|182837480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79|||<|0.001|TWO_SIDED|95.0|-5.96|-1.62||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.62|-5.96|<0.001
91481799|NCT00591578|182837480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||<|0.001|TWO_SIDED|95.0|-6.63|-2.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.24|-6.63|<0.001
91481800|NCT00591578|182837481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.008|TWO_SIDED|95.0|-3.48|-0.53||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.53|-3.48|0.008
91481801|NCT00591578|182837481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|||<|0.001|TWO_SIDED|95.0|-4.33|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.35|-4.33|<0.001
91525153|NCT00094328|182925584|OTHER|One sample t-test|Median Difference (Final Values)|-0.07||||0.882|TWO_SIDED|95.0|-1.15|1.0|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (SD units) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.00|-1.15|0.882
91525154|NCT03682705|182925592|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|90.0|-2.03|-0.85|||t-test, 2 sided|||Mixed-Effect Model Repeated Measure (MMRM) analysis was conducted, testing the superiority of the combination of upadacitinib 15 mg and elsubrutinib 60 mg compared to placebo at Week 12. Data collected after a participant discontinued study drug was considered as missing. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline DAS28 (CRP) measurement.||-0.85|-2.03|<0.001
91525155|NCT01874145|182925636|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.501|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.338|0.743||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group.|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.743|0.338|0.0006
91625034|NCT03549117|183142419|SUPERIORITY||Least square (LS) mean difference|0.15||||0.8142|TWO_SIDED|95.0|-1.14|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.45|-1.14|0.8142
91625035|NCT03549117|183142419|SUPERIORITY||LS mean difference|-0.7||||0.369|TWO_SIDED|95.0|-2.23|0.84||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||0.84|-2.23|0.3690
91625036|NCT03549117|183142419|SUPERIORITY||LS mean difference|-0.18||||0.7995|TWO_SIDED|95.0|-1.61|1.25||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline; between treatment 95% CI.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||1.25|-1.61|0.7995
91625037|NCT03549117|183142419|SUPERIORITY||LS mean difference|0.15||||0.7285|TWO_SIDED|95.0|-0.69|0.98||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.98|-0.69|0.7285
91662303|NCT00673660|183220550|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Total cholesterol||||<0.001
91481802|NCT00591578|182837482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.002|TWO_SIDED|95.0|-5.57|-1.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.30|-5.57|0.002
91481803|NCT00591578|182837482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01|||<|0.001|TWO_SIDED|95.0|-6.16|-1.85||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.85|-6.16|<0.001
91481804|NCT00591578|182837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.003|TWO_SIDED|95.0|-3.63|-0.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.72|-3.63|0.003
91791944|NCT01992159|183461639|SUPERIORITY||Treatment Difference|7.5|||<|0.0001|ONE_SIDED|95.0|6.5|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||6.5|< 0.0001
91791945|NCT01992159|183461639|SUPERIORITY||Treatment Difference|12.4|||<|0.0001|ONE_SIDED|95.0|11.1|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||11.1|< 0.0001
91791946|NCT01992159|183461639|SUPERIORITY||Treatment Difference|16.0|||<|0.0001|ONE_SIDED|95.0|14.6|||One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||14.6|< 0.0001
91791947|NCT01992159|183461640|SUPERIORITY||Treatment Difference|5.3|||<|0.0001|ONE_SIDED|95.0|4.4||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||4.4|< 0.0001
91791948|NCT01992159|183461640|SUPERIORITY||Treatment Difference|9.0|||<|0.0001|ONE_SIDED|95.0|8.0||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||8.0|< 0.0001
91791949|NCT01992159|183461640|SUPERIORITY||Treatment Difference|11.9|||<|0.0001|ONE_SIDED|95.0|10.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||10.6|< 0.0001
91791950|NCT01992159|183461641|SUPERIORITY||Treatment Difference|0.6||||0.125|ONE_SIDED|95.0|-0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.3|0.1250
91791951|NCT01992159|183461641|SUPERIORITY||Treatment Difference|1.7||||0.0002|ONE_SIDED|95.0|0.9||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.9|0.0002
91791952|NCT01992159|183461641|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.7|< 0.0001
91791953|NCT01992159|183461642|SUPERIORITY||Treatment Difference|1.5||||0.0012|ONE_SIDED|95.0|0.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.7|0.0012
91791954|NCT01992159|183461642|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.8||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.8|< 0.0001
91791955|NCT01992159|183461642|SUPERIORITY||Treatment Difference|4.1|||<|0.0001|ONE_SIDED|95.0|3.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||3.3|< 0.0001
91481805|NCT00591578|182837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-4.2|-1.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.25|-4.20|<0.001
91527764|NCT04250337|182930564|SUPERIORITY||LS Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.48||0.171|TWO_SIDED|95.0|-1.56|8.48|||ANCOVA|||||8.48|-1.56|0.171
91481806|NCT00591578|182837484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.76|-1.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.00|-5.76|0.005
91481807|NCT00591578|182837484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.005|TWO_SIDED|95.0|-5.87|-1.06||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.06|-5.87|0.005
91481808|NCT00591578|182837485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.009|TWO_SIDED|95.0|-4.04|-0.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.59|-4.04|0.009
91481809|NCT00591578|182837485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.004|TWO_SIDED|95.0|-4.34|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.84|-4.34|0.004
91481810|NCT00591578|182837486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.016|TWO_SIDED|95.0|1.07|2.0||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.00|1.07|0.016
91481811|NCT00591578|182837486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.002|TWO_SIDED|95.0|1.19|2.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.23|1.19|0.002
91625038|NCT03549117|183142420|SUPERIORITY||LS mean difference|-0.18||||0.7961|TWO_SIDED|95.0|-1.52|1.17||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.17|-1.52|0.7961
91625039|NCT03549117|183142420|SUPERIORITY||LS mean difference|-0.86||||0.271|TWO_SIDED|95.0|-2.41|0.68||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.68|-2.41|0.2710
91481812|NCT00591578|182837487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.041|TWO_SIDED|95.0|1.02|2.1||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.10|1.02|0.041
91481813|NCT00591578|182837487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.015|TWO_SIDED|95.0|1.09|2.28||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.28|1.09|0.015
91481814|NCT00591578|182837488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.018|TWO_SIDED|95.0|1.07|1.99||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||1.99|1.07|0.018
91625040|NCT03549117|183142420|SUPERIORITY||LS mean difference|-0.07||||0.9236|TWO_SIDED|95.0|-1.6|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||1.45|-1.60|0.9236
91625041|NCT03549117|183142420|SUPERIORITY||LS mean difference|-0.05||||0.8756|TWO_SIDED|95.0|-0.87|0.75||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.75|-0.87|0.8756
91662304|NCT00673660|183220550|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||LDL cholesterol||||<0.001
91662305|NCT00673660|183220550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 1 sided|||HDL cholesterol||||0.972
91662306|NCT00673660|183220550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Triglycerides||||0.034
91662307|NCT05919823|183220614|SUPERIORITY|Least-squares mean difference|Least-squares mean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.835||0.0014|TWO_SIDED|95.0|-14.8|-3.6|||Mixed model repeated measure|MMRM includes PANSS change at Weeks 2-5; fixed effects: treatment, visit, interaction; covariates: site, age, sex, baseline.|Numerator=KarXT/KarXT, denominator =Placebo/KarXT|||-3.6|-14.8|0.0014
91481815|NCT00591578|182837488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.24|2.33||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.33|1.24|<0.001
91527765|NCT04250337|182930565|SUPERIORITY||LS Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.697||0.109|TWO_SIDED|95.0|-1.03|9.89|||ANCOVA|||||9.89|-1.03|0.109
91527766|NCT04250337|182930566|SUPERIORITY||LS Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.116||0.922|TWO_SIDED|95.0|-0.22|0.24|||ANCOVA|||||0.24|-0.22|0.922
91662308|NCT05919823|183220615|SUPERIORITY|Least-squares mean difference|Least-squares mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.952||0.0474|TWO_SIDED|95.0|-3.8|0.0|||Mixed model for Repeated measures|includes PANSS change at Weeks 2-5; fixed effects: treatment, visit, interaction; covariates: site, age, sex, baseline PANSS positive symptom score.|Numerator=KarXT/KarXT, denominator =Placebo/KarXT|||0|-3.8|0.0474
91481816|NCT01723696|182837502|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.19|TWO_SIDED|95.0|-6.1|30.3||P-value adjusted for design factors of site, gestational age at randomization and covariates of length, race, and sex of infant.|ANCOVA|||Our targeted sample size of 218 infants with successful FEFs at 3 months of age was determined to detect with 90% power, at a significance level of 0.05, increases of 15% in mean FEF75 in the vitamin C group compared to the placebo group.||30.3|-6.1|0.19
91481817|NCT04721067|182837516|SUPERIORITY||Mean Difference (Net)|-2.27||||0.607|TWO_SIDED|95.0|-15.14|10.6|||Regression, Logistic|Adjusted for baseline values||||10.60|-15.14|0.607
91625042|NCT03549117|183142421|SUPERIORITY||LS mean difference|0.02||||0.9314|TWO_SIDED|95.0|-0.38|0.42||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.42|-0.38|0.9314
91481818|NCT04721067|182837517|SUPERIORITY||Mean Difference (Net)|-2.99||||0.766|TWO_SIDED|95.0|-10.74|4.76|||ANCOVA|||||4.76|-10.74|0.766
91481819|NCT04721067|182837518|SUPERIORITY||Mean Difference (Net)|145.54||||0.465|TWO_SIDED|95.0|-264.05|555.14|||ANCOVA|||||555.14|-264.05|0.465
91481820|NCT04721067|182837519|SUPERIORITY||Mean Difference (Net)|137.79||||0.178|TWO_SIDED|95.0|-68.71|344.3|||ANCOVA|||||344.30|-68.71|0.178
91625043|NCT03549117|183142421|SUPERIORITY||LS mean difference|-0.05||||0.8005|TWO_SIDED|95.0|-0.45|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.45|0.8005
91625044|NCT03549117|183142421|SUPERIORITY||LS mean difference|0.01||||0.9613|TWO_SIDED|95.0|-0.38|0.4||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.38|0.9613
91625045|NCT03549117|183142421|SUPERIORITY||LS mean difference|-0.14||||0.4966|TWO_SIDED|95.0|-0.54|0.26||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.26|-0.54|0.4966
91625046|NCT03549117|183142422|SUPERIORITY||LS mean difference|0.03||||0.8775|TWO_SIDED|95.0|-0.39|0.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.45|-0.39|0.8775
91625047|NCT03549117|183142422|SUPERIORITY||LS mean difference|-0.06||||0.7747|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.47|0.7747
91662309|NCT05919823|183220616|SUPERIORITY|Least-squares mean difference|Least-squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.887||0.0062|TWO_SIDED|95.0|-4.2|-0.7|||Mixed model for Repeated measures|includes PANSS change at Weeks 2-5; fixed effects: treatment, visit, interaction; covariates: site, age, sex, baseline PANSS positive symptom score.||||-0.7|-4.2|0.0062
91481821|NCT04721067|182837520|SUPERIORITY||Mean Difference (Net)|1.87||||0.548|TWO_SIDED|95.0|-4.58|8.31|||ANCOVA|||||8.31|-4.58|0.548
91625048|NCT03549117|183142422|SUPERIORITY||LS mean difference|0.04||||0.8535|TWO_SIDED|95.0|-0.39|0.47||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.47|-0.39|0.8535
91662310|NCT05919823|183220617|SUPERIORITY|Least-squares mean difference|Least-squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.906||0.0056|TWO_SIDED|95.0|-4.3|-0.8|||Mixed model for Repeated measures|includes PANSS change at Weeks 2-5; fixed effects: treatment, visit, interaction; covariates: site, age, sex, baseline PANSS positive symptom score.||||-0.8|-4.3|0.0056
91481822|NCT04721067|182837521|SUPERIORITY||Mean Difference (Net)|-0.67||||0.579|TWO_SIDED|95.0|-3.14|1.8|||ANCOVA|||||1.80|-3.14|0.579
91481823|NCT04721067|182837522|SUPERIORITY||Mean Difference (Net)|-0.63||||0.766|TWO_SIDED|95.0|-5.0|3.74|||ANCOVA|||||3.74|-5.00|0.766
91481824|NCT04721067|182837523|SUPERIORITY||Mean Difference (Net)|-1.23||||0.42|TWO_SIDED|95.0|-4.39|1.93|||ANCOVA|||||1.93|-4.39|0.42
91481825|NCT04721067|182837524|SUPERIORITY||Mean Difference (Net)|-0.07||||0.91|TWO_SIDED|95.0|-1.34|1.2|||ANCOVA|||||1.20|-1.34|0.91
91481826|NCT04721067|182837525|SUPERIORITY||Mean Difference (Net)|0.79||||0.73|TWO_SIDED|95.0|-4.03|5.6|||ANCOVA|||||5.60|-4.03|0.73
91481827|NCT04721067|182837526|SUPERIORITY||Mean Difference (Net)|0.19||||0.42|TWO_SIDED|95.0|-0.3|0.68|||ANCOVA|||||0.68|-0.30|0.42
91481828|NCT04721067|182837527|SUPERIORITY||Mean Difference (Net)|1.79||||0.18|TWO_SIDED|95.0|-0.9|4.48|||ANCOVA|||||4.48|-0.90|0.18
91481829|NCT04721067|182837528|SUPERIORITY||Mean Difference (Net)|-2.03||||0.48|TWO_SIDED|95.0|-7.97|3.9|||ANCOVA|||||3.90|-7.97|0.48
91481830|NCT04721067|182837529|SUPERIORITY||Mean Difference (Net)|1.42||||0.08|TWO_SIDED|95.0|-0.24|3.08|||ANCOVA|||||3.08|-0.24|0.08
91481831|NCT04721067|182837530|SUPERIORITY||Mean Difference (Net)|0.51||||0.94|TWO_SIDED|95.0|-13.5|14.52|||ANCOVA|||||14.52|-13.50|0.94
91481832|NCT04721067|182837533|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.32|TWO_SIDED|95.0|-0.45|1.32|||t-test, 2 sided|||||1.32|-0.45|0.32
91481833|NCT04721067|182837534|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.61|TWO_SIDED|95.0|-0.75|1.25|||t-test, 2 sided|||||1.25|-0.75|0.61
91481834|NCT04721067|182837535|SUPERIORITY||Mean Difference (Net)|-1.05||||0.52|TWO_SIDED|95.0|-4.42|2.31|||ANCOVA|||||2.31|-4.42|0.52
91481835|NCT04721067|182837536|SUPERIORITY||Mean Difference (Net)|-0.44||||0.61|TWO_SIDED|95.0|-2.2|1.32|||ANCOVA|||||1.32|-2.20|0.61
91481836|NCT04721067|182837537|SUPERIORITY||Mean Difference (Net)|3.68||||0.16|TWO_SIDED|95.0|-1.61|8.97|||ANCOVA|||||8.97|-1.61|0.16
91625049|NCT03549117|183142422|SUPERIORITY||LS mean difference|-0.06||||0.772|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.35|-0.47|0.7720
91481837|NCT04721067|182837538|SUPERIORITY||Mean Difference (Net)|0.43||||0.13|TWO_SIDED|95.0|-0.13|1.0|||ANCOVA|||||1.00|-0.13|0.13
91481838|NCT04721067|182837539|SUPERIORITY||Mean Difference (Net)|3.88||||0.03|TWO_SIDED|95.0|0.35|7.41|||ANCOVA|||||7.41|0.35|0.03
91481839|NCT04721067|182837540|SUPERIORITY||Mean Difference (Net)|-3.2||||0.41|TWO_SIDED|95.0|-11.07|4.66|||ANCOVA|||||4.66|-11.07|0.41
91625050|NCT03549117|183142423|SUPERIORITY|||||||0.9258|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.9258
91625051|NCT03549117|183142423|SUPERIORITY|||||||0.2368|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.2368
91481840|NCT04721067|182837541|SUPERIORITY||Mean Difference (Net)|1.7||||0.17|TWO_SIDED|95.0|-0.83|4.22|||ANCOVA|||||4.22|-0.83|0.17
91481841|NCT04721067|182837542|SUPERIORITY||Mean Difference (Net)|3.49||||0.58|TWO_SIDED|95.0|-9.58|16.55|||ANCOVA|||||16.55|-9.58|0.58
91481842|NCT04721067|182837543|SUPERIORITY||Mean Difference (Net)|0.15||||0.74|TWO_SIDED|95.0|-0.79|1.1|||ANCOVA|||||1.10|-0.79|0.74
91481843|NCT04721067|182837544|SUPERIORITY||Mean Difference (Net)|129.077||||0.17|TWO_SIDED|95.0|-57.78|315.92|||ANCOVA|||||315.92|-57.78|0.17
91481844|NCT04721067|182837545|SUPERIORITY||Mean Difference (Net)|109.71||||0.31|TWO_SIDED|95.0|-108.37|327.78|||ANCOVA|||||327.78|-108.37|0.31
91481845|NCT04721067|182837546|SUPERIORITY||Mean Difference (Net)|0.24||||0.92|TWO_SIDED|95.0|-4.52|5.0|||ANCOVA|||||5.00|-4.52|0.92
91481846|NCT04721067|182837547|SUPERIORITY||Mean Difference (Net)|-1.11||||0.66|TWO_SIDED|95.0|-6.28|4.06|||ANCOVA|||||4.06|-6.28|0.66
91481847|NCT04480424|182837583|SUPERIORITY||Risk Difference|-4.0||||0.8275|TWO_SIDED|95.0|-22.3|14.5||p-value was calculated using Fisher's exact method with 5% level of significance to test the null hypothesis of no difference in mortality rate between the two treatment groups.|Fisher Exact|||||14.5|-22.3|0.8275
91481848|NCT04480424|182837584|SUPERIORITY|||||||0.8599||||||p-value was calculated using Gray's test for equality of the Cumulative Incidence Function (CIF) between treatment groups.|Gray's test|||||||0.8599
91625052|NCT03549117|183142423|SUPERIORITY|||||||0.4432|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4432
91625053|NCT03549117|183142423|SUPERIORITY|||||||0.9856|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.9856
91662311|NCT05919823|183220618|SUPERIORITY|Least-squares mean difference|Least-squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.165||0.0208|TWO_SIDED|95.0|-0.7|-0.1|||Mixed model for repeated measures|ncludes PANSS change at Weeks 2-5; fixed effects: treatment, visit, interaction; covariates: site, age, sex, baseline PANSS positive symptom score.||||-0.1|-0.7|0.0208
91481849|NCT04480424|182837585|SUPERIORITY||Least Square Mean (LSM) Difference|2.58||||0.2626|TWO_SIDED|95.0|-1.96|7.12||p-value was calculated using an Analysis of Variance (ANOVA) model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.12|-1.96|0.2626
91481850|NCT04480424|182837586|SUPERIORITY|||||||0.6854||||||p-value was calculated using Gray's test for equality of the CIF between treatment groups.|Gray's test|||||||0.6854
91481851|NCT04480424|182837587|SUPERIORITY||LSM Difference|-0.02||||0.9917|TWO_SIDED|95.0|-3.82|3.78||95% CI for difference in least square mean (LSM) between treatment groups and the associated p-value were calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||3.78|-3.82|0.9917
91481852|NCT04480424|182837588|SUPERIORITY||LSM Difference|0.05||||0.7557|TWO_SIDED|95.0|-0.29|0.4|||Kenward-Roger|p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.||||0.40|-0.29|0.7557
91481853|NCT04480424|182837589|SUPERIORITY||LSM Difference|0.4||||0.0922|TWO_SIDED|95.0|-0.07|0.86||p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||||0.86|-0.07|0.0922
91481854|NCT04480424|182837593|SUPERIORITY||Kenward-Roger|0.4||||0.3611|TWO_SIDED|95.0|-0.47|1.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.28|-0.47|0.3611
91481855|NCT04480424|182837593|SUPERIORITY||Kenward-Roger|-0.1||||0.9238|TWO_SIDED|95.0|-2.13|1.94||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.94|-2.13|0.9238
91481856|NCT04480424|182837593|SUPERIORITY||Kenward-Roger|0.08||||0.9541|TWO_SIDED|95.0|-2.58|2.73||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||2.73|-2.58|0.9541
91481857|NCT04480424|182837594|SUPERIORITY||LSM Difference|0.06||||0.9366|TWO_SIDED|95.0|-1.42|1.53||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.53|-1.42|0.9366
91481858|NCT04894916|182837596|OTHER|single group|mean|81.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is equal to 71."||||<0.001
91481859|NCT04894916|182837599|SUPERIORITY||Mean Difference (Net)|0.73|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91481860|NCT04894916|182837600|OTHER||Mean Difference (Net)|1.17||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
91625054|NCT03549117|183142423|SUPERIORITY|||||||0.7854|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.7854
91625055|NCT03549117|183142423|SUPERIORITY|||||||0.4141|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.4141
91481861|NCT04894916|182837601|OTHER|||||||0.68|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.68
91481862|NCT04894916|182837601|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.18
91481863|NCT04894916|182837601|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.18
91481864|NCT04894916|182837601|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.17
91481865|NCT04894916|182837601|OTHER|||||||0.33|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.33
91625056|NCT03549117|183142423|SUPERIORITY|||||||0.3028|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.3028
91481866|NCT04894916|182837601|OTHER|||||||0.4|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.40
91481867|NCT04894916|182837601|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
91481868|NCT04894916|182837601|OTHER|||||||0.37|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||0.37
91481869|NCT04894916|182837602|OTHER||Mean Difference (Net)|-0.71||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
91481870|NCT04894916|182837603|OTHER|||||||0.03|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.03
91481871|NCT04894916|182837603|OTHER|||||||0.45|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||0.45
91625057|NCT03549117|183142423|SUPERIORITY|||||||0.3955|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3955
91625058|NCT03549117|183142424|SUPERIORITY|||||||0.3826|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.3826
91625059|NCT03549117|183142424|SUPERIORITY|||||||0.6251|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.6251
91625060|NCT03549117|183142424|SUPERIORITY|||||||0.2381|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.2381
91625061|NCT03549117|183142424|SUPERIORITY|||||||0.4245|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4245
91625062|NCT03549117|183142424|SUPERIORITY|||||||0.8213|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.8213
91481872|NCT04894916|182837603|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.||||0.17
91481873|NCT04894916|182837603|OTHER|||||||0.62|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.62
91481874|NCT04894916|182837605|OTHER||Mean Difference (Net)|0.09||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
91481875|NCT04894916|182837606|OTHER||Mean Difference (Net)|0.03||||0.86|TWO_SIDED||||||t-test, 2 sided|||||||0.86
91481876|NCT04894916|182837607|OTHER||Mean Difference (Net)|0.28||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
91481877|NCT04894916|182837608|OTHER||Mean Difference (Net)|0.25||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
91481878|NCT04894916|182837609|OTHER||Mean Difference (Net)|-0.39||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
91481879|NCT04233034|182837620|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.89|TWO_SIDED|95.0|-0.11|0.1|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.10|-0.11|0.89
91481880|NCT04233034|182837620|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.04|TWO_SIDED|95.0|0.01|0.27|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.27|0.01|0.04
91481881|NCT04233034|182837621|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8|TWO_SIDED|95.0|-0.1|0.08||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.08|-0.10|0.80
91527767|NCT04250337|182930567|SUPERIORITY||LS Mean Difference (Final Values)|-4.62|STANDARD_ERROR_OF_MEAN|1.271||0.001|TWO_SIDED|95.0|-7.22|-2.03|||Mixed Models Analysis|||||-2.03|-7.22|0.001
91625063|NCT03549117|183142424|SUPERIORITY|||||||0.1823|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.1823
91625064|NCT03549117|183142424|SUPERIORITY|||||||0.7744|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.7744
91625065|NCT03549117|183142424|SUPERIORITY|||||||0.5811|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.5811
91662312|NCT05919823|183220619|SUPERIORITY||Percentage difference|15.8||||0.0402|TWO_SIDED|95.0|0.7|29.9|||Chi-squared|||||29.9|0.7|0.0402
91662313|NCT01648582|183220639|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.74|-0.4||||||||-0.40|-0.74|
91662314|NCT01648582|183220639|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.35|-0.01||||||||-0.01|-0.35|
91625066|NCT00605072|183142431|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||p-value for between group comparison (group\*visit)|Mixed Models Analysis|Adjusted for baseline AGE and Mini-Mental-State-Examination||||||0.008
91625067|NCT00605072|183142432|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Mixed Models Analysis|adjusted for age||||||0.74
91625068|NCT00605072|183142433|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Adjusted for age at baseline||||||0.81
91481882|NCT04233034|182837621|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED|95.0|-0.08|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.13|-0.08|0.80
91481883|NCT04233034|182837621|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8|TWO_SIDED|95.0|-0.13|0.09||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.09|-0.13|0.80
91625069|NCT00605072|183142434|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Mixed Models Analysis|||||||0.87
91625070|NCT00605072|183142435|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|||||||0.79
91625071|NCT02259127|183142436|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.004|TWO_SIDED|95.0|-0.14|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Primary: Diff in adj. KM estimates (\>=14kg)~Number of subjects included in analysis: 707~Analysis specification: Pre-specified"||-0.03|-0.14|= 0.004
91481884|NCT04233034|182837621|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|95.0|-0.09|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.13|-0.09|0.69
91481885|NCT04233034|182837621|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.08|TWO_SIDED|95.0|-0.02|0.25||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.25|-0.02|0.08
91625072|NCT02259127|183142436|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18|||=|0.057|TWO_SIDED|95.0|-0.36|0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Diff in adj. KM estimates (Frequentist \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.02|-0.36|=0.057
91625073|NCT02259127|183142436|NON_INFERIORITY|Bayesian estimation was used for the primary analysis of the difference in treatment failure by 96 weeks by arm in \<14kg cohort. An informative prior distribution was used based on the treatment effect observed in \>=14kg cohort, with relative weight defined by clinical opinion, solicited prior to the main trial results.|Risk Difference (RD)|-0.1||||0.02|TWO_SIDED|95.0|-0.19|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Primary: diff in adj. KM estimates (Bayesian \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-0.02|-0.19|0.02
91625074|NCT02259127|183142436|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12||||0.003|TWO_SIDED|95.0|-0.21|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A\>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.04|-0.21|0.003
91625075|NCT02259127|183142436|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05||||0.22|TWO_SIDED|95.0|-0.12|0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.03|-0.12|0.22
91625076|NCT02259127|183142437|SUPERIORITY||Risk Difference (RD)|5.0|||=|0.1377|TWO_SIDED|95.0|-1.0|11.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 665~Analysis Specification: Pre-specified"||11|-1|= 0.1377
91662315|NCT01648582|183220640|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.77|-0.38||||||||-0.38|-0.77|
91662316|NCT01648582|183220640|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.33|-0.06||||||||-0.06|-0.33|
91662317|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||\<7.0% Week 26||||<0.001
91662318|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||\<7.0 Week 26||||0.004
91662319|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
91481886|NCT04233034|182837621|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.08|TWO_SIDED|95.0|-0.01|0.28||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.28|-0.01|0.08
91481887|NCT04233034|182837624|SUPERIORITY||Mean Difference (Final Values)|-25.0|||<|0.001|TWO_SIDED|95.0|-37.0|-14.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-14|-37|<0.001
91481888|NCT04233034|182837624|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.74|TWO_SIDED|95.0|-25.0|16.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||16|-25|0.74
91481889|NCT04233034|182837625|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
91625077|NCT02259127|183142437|SUPERIORITY||Risk Difference (RD)|-1.0|||=|0.8895|TWO_SIDED|95.0|-10.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||8|-10|= 0.8895
91625078|NCT02259127|183142437|SUPERIORITY||Risk Difference (RD)|9.0|||=|0.0435|TWO_SIDED|95.0|0.4|17.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 381~Analysis Specification: Pre-specified"||17|0.4|=0.0435
91625079|NCT02259127|183142437|SUPERIORITY||Risk Difference (RD)|26.0||||0.021|TWO_SIDED|95.0|6.0|47.0|||Regression, Logistic|||||47|6|0.021
91625080|NCT02259127|183142438|SUPERIORITY||Risk Difference (RD)|3.0|||=|0.2256|TWO_SIDED|95.0|-2.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 670~Analysis Specification: Pre-specified"||8|-2|= 0.2256
91481890|NCT04233034|182837625|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.74|TWO_SIDED|95.0|-9.0|13.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||13|-9|0.74
91481891|NCT04233034|182837626|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
91481892|NCT04233034|182837626|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.95|TWO_SIDED|95.0|-8.0|14.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||14|-8|0.95
91481893|NCT04233034|182837627|SUPERIORITY||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.21|0.53|||Regression, Logistic|||||0.53|0.21|<0.001
91481894|NCT04233034|182837627|SUPERIORITY||Risk Difference (RD)|0.03||||0.79|TWO_SIDED|95.0|-0.26|0.32|||Regression, Logistic|||||0.32|-0.26|0.79
91481895|NCT04233034|182837629|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-22.0|-9.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-9|-22|<0.001
91625081|NCT02259127|183142438|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.9536|TWO_SIDED|95.0|-8.0|7.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||7|-8|= 0.9536
91625082|NCT02259127|183142438|SUPERIORITY||Risk Difference (RD)|6.0|||=|0.1104|TWO_SIDED|95.0|-1.0|12.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 384~Analysis Specification: Pre-specified"||12|-1|= 0.1104
91481896|NCT04233034|182837629|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.74|TWO_SIDED|95.0|-13.0|9.0|||Mixed Models Analysis||Mean difference at 52 weeks (verapamil - placebo) adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||9|-13|0.74
91481897|NCT04233034|182837630|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED|95.0|-7.0|-1.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-1|-7|0.003
91481898|NCT04233034|182837630|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.74|TWO_SIDED|95.0|-6.0|4.0|||Mixed Models Analysis||Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||4|-6|0.74
91625083|NCT02259127|183142438|SUPERIORITY||Risk Difference (RD)|19.0||||0.038|TWO_SIDED|95.0|2.0|37.0|||Regression, Logistic|||||37|2|0.038
91481899|NCT04233034|182837631|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.17|-0.04|0.23
91481900|NCT04233034|182837631|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.79|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.79
91662320|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
91662321|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<7.0% Week 52||||<0.001
91662322|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Fisher Exact|||\<7.0% Week 52||||0.002
91662323|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
91662324|NCT01648582|183220641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
91662325|NCT01648582|183220642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.24||||0.177|TWO_SIDED|95.0|-0.11|0.59|||Mixed Models Analysis|||Week 26||0.59|-0.11|0.177
91662326|NCT01648582|183220642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.88|||<|0.001|TWO_SIDED|95.0|0.53|1.23|||Mixed Models Analysis|||Week 26||1.23|0.53|<0.001
91481901|NCT04233034|182837632|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.39|TWO_SIDED|95.0|-0.3|0.7|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.7|-0.3|0.39
91481902|NCT04233034|182837632|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.74|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.74
91481903|NCT04233034|182837634|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-0.3|-1.1|<0.001
91625084|NCT02259127|183142439|SUPERIORITY||Mean Difference (Final Values)|35.0|||=|0.144|TWO_SIDED|95.0|-12.0|82.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusted for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||82|-12|= 0.144
91625085|NCT02259127|183142439|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.185|TWO_SIDED|95.0|-21.0|109.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||109|-21|0.185
91625086|NCT02259127|183142439|SUPERIORITY||Mean Difference (Final Values)|27.0|||=|0.427|TWO_SIDED|95.0|-39.0|93.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||93|-39|= 0.427
91625087|NCT02259127|183142439|SUPERIORITY||Median Difference (Final Values)|30.0||||0.86|TWO_SIDED|95.0|-308.0|368.0|||Regression, Linear|||||368|-308|0.86
91625088|NCT02259127|183142440|SUPERIORITY||Mean Difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-19.0|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-11.1|-19|< 0.001
91481904|NCT04233034|182837634|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.65|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.4|-1.0|0.65
91481905|NCT04233034|182837637|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.07|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.20|-0.01|0.07
91481906|NCT04233034|182837637|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.52|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.05|-0.30|0.52
91625089|NCT02259127|183142440|SUPERIORITY||Mean Difference (Final Values)|-24.4|||=|0.0032|TWO_SIDED|95.0|-40.3|-8.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\<14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-8.5|-40.3|= 0.0032
91625090|NCT02259127|183142440|SUPERIORITY||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-23.9|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-11.1|-23.9|< 0.001
91625091|NCT02259127|183142440|SUPERIORITY||Mean Difference (Final Values)|-13.4|||<|0.001|TWO_SIDED|95.0|-18.5|-8.4|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-8.4|-18.5|< 0.001
91662327|NCT01648582|183220642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.518|TWO_SIDED|95.0|-0.25|0.5|||Mixed Models Analysis|||Week 52||0.50|-0.25|0.518
91481907|NCT05523323|182837674|OTHER||Estimate difference|29.5||||0.0002014|TWO_SIDED|95.0|14.0|43.9|||Unstratified Miettinen & Nurminen method|One-sided p-value was calculated using the unstratified Miettinen \& Nurminen method.|The exact binomial method by Clopper and Pearson was used to generate the estimate difference and the associated 95% confidence intervals (CIs).|||43.9|14.0|0.0002014
91481908|NCT05523323|182837675|OTHER||Hazard Ratio (HR)|0.34||||3.7e-06|TWO_SIDED|95.0|0.21|0.55|||unstratified Log-rank test.|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||0.55|0.21|0.0000037
91481909|NCT05523323|182837676|OTHER||Hazard Ratio (HR)|0.86||||0.30933|TWO_SIDED|95.0|0.49|1.54|||Unstratified Log-rank test|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||1.54|0.49|0.30933
91481910|NCT05654441|182837680|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91481911|NCT05654441|182837681|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91481912|NCT05654441|182837682|OTHER|||||||0.007|||||||ANOVA|||||||0.007
91481913|NCT05654441|182837683|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91791956|NCT01992159|183461643|SUPERIORITY||Treatment Difference|0.3||||0.2846|ONE_SIDED|95.0|-0.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.6|0.2846
91625092|NCT02259127|183142441|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.53|TWO_SIDED|95.0|0.55|1.36|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.36|0.55|= 0.53
91625093|NCT02259127|183142441|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.86|TWO_SIDED|95.0|0.47|2.49|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2.49|0.47|= 0.86
91625094|NCT02259127|183142441|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.52|TWO_SIDED|95.0|0.48|1.46|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.46|0.48|= 0.52
91625095|NCT02259127|183142441|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.86|TWO_SIDED|95.0|0.42|2.04|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||2.04|0.42|= 0.86
91625096|NCT02259127|183142442|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.24|TWO_SIDED|95.0|0.61|1.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.13|0.61|= 0.24
91625097|NCT02259127|183142442|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.83|TWO_SIDED|95.0|0.5|1.74|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||1.74|0.5|= 0.83
91662328|NCT01648582|183220642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.82|||<|0.001|TWO_SIDED|95.0|0.45|1.2|||Mixed Models Analysis|||Week 52||1.20|0.45|<0.001
91662329|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|||<|0.001|TWO_SIDED|95.0|0.42|0.88|||Mixed Models Analysis|||Morning pre-meal, Week 26||0.88|0.42|<0.001
91791957|NCT01992159|183461643|SUPERIORITY||Treatment Difference|1.3||||0.0151|ONE_SIDED|95.0|0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.3|0.0151
91791958|NCT01992159|183461643|SUPERIORITY||Treatment Difference|2.6||||0.0001|ONE_SIDED|95.0|1.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.5|0.0001
91791959|NCT01992159|183461644|SUPERIORITY||Treatment Difference|1.6||||0.0067|ONE_SIDED|95.0|0.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.5|0.0067
91625098|NCT02259127|183142442|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.57|TWO_SIDED|95.0|0.75|1.7|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.7|0.75|= 0.57
91791960|NCT01992159|183461644|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.6|< 0.0001
91791961|NCT01992159|183461644|SUPERIORITY||Treatment Difference|3.5|||<|0.0001|ONE_SIDED|95.0|2.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||2.3|< 0.0001
91791962|NCT01992159|183461649|SUPERIORITY||Treatment Difference|-15.3||||0.5084|TWO_SIDED|95.0|-60.8|30.2|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||30.2|-60.8|0.5084
91625099|NCT02259127|183142442|SUPERIORITY||Hazard Ratio (HR)|0.54|||=|0.01|TWO_SIDED|95.0|0.33|0.88|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.88|0.33|= 0.01
91625100|NCT02259127|183142443|SUPERIORITY||Hazard Ratio (HR)|0.29|||=|0.01|TWO_SIDED|95.0|0.11|0.77|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.77|0.11|= 0.01
91481914|NCT05654441|182837684|OTHER|||||||0.886|||||||t-test, 2 sided|||||||0.886
91662330|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||Morning pre-meal, Week 26||1.17|0.71|<0.001
91662331|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.49||||0.024|TWO_SIDED|95.0|-0.92|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||-0.07|-0.92|0.024
91662332|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.617|TWO_SIDED|95.0|-0.53|0.32|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||0.32|-0.53|0.617
91662333|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.055|TWO_SIDED|95.0|-0.7|0.01|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.01|-0.70|0.055
91662334|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.03||||0.855|TWO_SIDED|95.0|-0.32|0.39|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.39|-0.32|0.855
91662335|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.05|||<|0.001|TWO_SIDED|95.0|-1.46|-0.64|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.64|-1.46|<0.001
91481915|NCT05654441|182837685|OTHER|||||||0.666|||||||t-test, 2 sided|||||||.666
91662336|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.01|-0.19|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.19|-1.01|0.004
91662337|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.97|-0.29|||Mixed Models Analysis|||Evening pre-meal, Week 26||-0.29|-0.97|<0.001
91662338|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.489|TWO_SIDED|95.0|-0.45|0.22|||Mixed Models Analysis|||Evening pre-meal, Week 26||0.22|-0.45|0.489
91662339|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.89|||<|0.001|TWO_SIDED|95.0|-1.3|-0.48|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.48|-1.30|<0.001
91662340|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.47||||0.024|TWO_SIDED|95.0|-0.88|-0.06|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.06|-0.88|0.024
91662341|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.79|||<|0.001|TWO_SIDED|95.0|-1.17|-0.41|||Mixed Models Analysis|||Bedtime, Week 26||-0.41|-1.17|<0.001
91662342|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.067|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Analysis|||Bedtime, Week 26||-0.03|-0.73|0.067
91662343|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.77|||<|0.001|TWO_SIDED|95.0|0.52|1.01|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.01|0.52|<0.001
91662344|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|0.82|1.31|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.31|0.82|<0.001
91662345|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.53||||0.025|TWO_SIDED|95.0|-1.0|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||-0.07|-1.00|0.025
91662346|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21||||0.384|TWO_SIDED|95.0|-0.67|0.26|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||0.26|-0.67|0.384
91662347|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.43||||0.024|TWO_SIDED|95.0|-0.8|-0.06|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||-0.06|-0.80|0.024
91662348|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05||||0.783|TWO_SIDED|95.0|-0.32|0.42|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||0.42|-0.32|0.783
91481916|NCT05654441|182837686|OTHER|||||||0.522|||||||t-test, 2 sided|||||||.522
91481917|NCT05654441|182837687|OTHER|||||||0.438|||||||t-test, 2 sided|||||||.438
91481918|NCT05654441|182837688|OTHER|||||||0.181|||||||t-test, 2 sided|||||||.181
91481919|NCT05654441|182837689|OTHER|||||||0.833|||||||t-test, 2 sided|||||||.833
91481920|NCT05654441|182837690|OTHER|||||||0.455|||||||t-test, 2 sided|||||||.455
91481921|NCT05007717|182837727|SUPERIORITY||Risk Ratio (RR)|1.04||||0.631|TWO_SIDED|95.0|0.89|1.2|||Mixed Models Analysis|Adjusted for ever missing a visit during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.20|0.89|0.631
91481922|NCT05007717|182837728|SUPERIORITY||Risk Ratio (RR)|0.79||||0.237|TWO_SIDED|95.0|0.54|1.16|||Mixed Models Analysis|Adjusted for ever being virally unsuppressed during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.16|0.54|0.237
91662349|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63||||0.004|TWO_SIDED|95.0|-1.07|-0.2|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.20|-1.07|0.004
91662350|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.48||||0.029|TWO_SIDED|95.0|-0.92|-0.05|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.05|-0.92|0.029
91662351|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-1.01|-0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||-0.27|-1.01|<0.001
91662352|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.603|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||0.27|-0.47|0.603
91662353|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.26|-0.41|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.41|-1.26|<0.001
91662354|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.02|-0.87|0.039
91662355|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.39|-0.6|||Mixed Models Analysis|||Bedtime, Week 52||-0.60|-1.39|<0.001
91662356|NCT01648582|183220643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.98|-0.2|||Mixed Models Analysis|||Bedtime, Week 52||-0.20|-0.98|0.003
91662357|NCT01648582|183220644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.41|STANDARD_ERROR_OF_MEAN|3.831||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5 mg, Week 26||||0.352
91662358|NCT01648582|183220644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|31.17|STANDARD_ERROR_OF_MEAN|3.761||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 26||||0.352
91662359|NCT01648582|183220644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.12|STANDARD_ERROR_OF_MEAN|4.147||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5, Week 52||||0.025
91662360|NCT01648582|183220644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.64|STANDARD_ERROR_OF_MEAN|4.061||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 52||||0.025
91662361|NCT01648582|183220645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.57|STANDARD_ERROR_OF_MEAN|2.977||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 26||||0.025
91662362|NCT01648582|183220645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.42|STANDARD_ERROR_OF_MEAN|2.94||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 26||||0.025
91625101|NCT02259127|183142443|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.13|TWO_SIDED|95.0|0.09|1.33|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.33|0.09|= 0.13
91625102|NCT02259127|183142443|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.055|TWO_SIDED|95.0|0.05|1.03|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.03|0.05|0.055
91481923|NCT05007717|182837729|SUPERIORITY||Risk Ratio (RR)|0.98||||0.386|TWO_SIDED|95.0|0.94|1.02|||Mixed Models Analysis|Adjusted for always having \>80% coverage during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.02|0.94|0.386
91481924|NCT05007717|182837730|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.991|TWO_SIDED|95.0|0.71|1.41|||Regression, Cox|Adjusted for always coming to clinic by yourself.||||1.41|0.71|0.991
91481925|NCT05007717|182837731|SUPERIORITY||Risk Ratio (RR)|1.21||||0.037|TWO_SIDED|95.0|1.01|1.46|||Mixed Models Analysis|Adjusted for having been given fast track visits during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.46|1.01|0.037
91481926|NCT05007717|182837732|SUPERIORITY||Risk Ratio (RR)|1.04||||0.276|TWO_SIDED|95.0|0.97|1.12|||Mixed Models Analysis|Adjusted for having been given long intervals during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.12|0.97|0.276
91481927|NCT01117051|182837733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Cochran-Mantel-Haenszel|||||||0.305
91662363|NCT01648582|183220645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|41.02|STANDARD_ERROR_OF_MEAN|2.9||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 52||||0.029
91662364|NCT01648582|183220645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.19|STANDARD_ERROR_OF_MEAN|2.864||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 52||||0.029
91481928|NCT03355664|182837758|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.38|TWO_SIDED|95.0|0.2|1.9|||Regression, Cox|||||1.9|0.2|0.38
91481929|NCT02821910|182837792|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.7|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|92.89|100.66|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.66|92.89|
91481930|NCT02821910|182837792|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.8|STANDARD_DEVIATION|4.8|||TWO_SIDED|90.0|97.99|103.7|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.70|97.99|
91662365|NCT01648582|183220648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Overall p-value|Mixed Models Analysis|||Week 26 SBP||||0.008
91662366|NCT01648582|183220648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.584||||||Overall p-value|Mixed Models Analysis|||Week 26 DBP||||0.584
91791963|NCT01992159|183461649|SUPERIORITY||Treatment Difference|84.1||||0.0002|TWO_SIDED|95.0|40.1|128.0|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||128.0|40.1|0.0002
91481931|NCT02821910|182837792|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.83|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|95.96|103.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.85|95.96|
91481932|NCT02821910|182837793|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.82|STANDARD_DEVIATION|9.7|||TWO_SIDED|90.0|90.65|103.42|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.42|90.65|
91625103|NCT02259127|183142444|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.06|||=|0.003|TWO_SIDED|95.0|-0.1|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.02|-0.1|= 0.003
91662367|NCT01648582|183220648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||||||Overall p-value|Mixed Models Analysis|||Week 52 SBP||||0.169
91662368|NCT01648582|183220648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||Overall p-value|Mixed Models Analysis|||Week 52 DBP||||0.110
91662369|NCT01648582|183220649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 26||||<0.001
91662370|NCT01648582|183220649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 52||||<0.001
91662371|NCT01648582|183220656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 26|Mixed Models Analysis|||||||<0.001
91662372|NCT01648582|183220656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
91662373|NCT01648582|183220657|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 26||||<0.001
91662374|NCT01648582|183220657|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
91791964|NCT01992159|183461649|SUPERIORITY||Treatment Difference|153.8|||<|0.0001|TWO_SIDED|95.0|109.2|198.4|||ANCOVA|ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||198.4|109.2|< 0.0001
91625104|NCT02259127|183142444|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.035|TWO_SIDED|95.0|-0.13|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.01|-0.13|= 0.035
91625105|NCT02259127|183142444|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05|||=|0.039|TWO_SIDED|95.0|-0.11|-0.004|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-0.004|-0.11|= 0.039
91625106|NCT02259127|183142444|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18||||0.057|TWO_SIDED|95.0|-0.36|0.02|||Other [Bootstrap method]|||||0.02|-0.36|0.057
91625107|NCT02259127|183142445|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.09|||=|0.003|TWO_SIDED|95.0|-0.16|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.04|-0.16|= 0.003
91625108|NCT02259127|183142445|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12|||=|0.009|TWO_SIDED|95.0|-0.21|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.03|-0.21|= 0.009
91625109|NCT02259127|183142445|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.079|TWO_SIDED|95.0|-0.16|0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.01|-0.16|= 0.079
91625110|NCT02259127|183142446|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.993|TWO_SIDED|95.0|0.38|2.68|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||2.68|0.38|= 0.993
91625111|NCT02259127|183142446|SUPERIORITY||Hazard Ratio (HR)|0.5|||=|0.33|TWO_SIDED|95.0|0.13|2.0|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2|0.13|= 0.33
91625112|NCT02259127|183142446|SUPERIORITY||Hazard Ratio (HR)|1.01|||=|0.991|TWO_SIDED|95.0|0.32|3.12|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||3.12|0.32|= 0.991
91625113|NCT02259127|183142446|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.997|TWO_SIDED|95.0|0.14|7.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||7.13|0.14|= 0.997
91625114|NCT02259127|183142447|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.015|TWO_SIDED|95.0|-0.12|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 677~Analysis Specification: Pre-specified"||-0.01|-0.12|= 0.015
91625115|NCT02259127|183142447|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.172|||=|0.075|TWO_SIDED|95.0|-0.362|0.029|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Adjusted difference (frequentist \<14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.029|-0.362|= 0.075
91662375|NCT04614168|183220661|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||||||>0.99
91662376|NCT04614168|183220661|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91662377|NCT04614168|183220662|SUPERIORITY|||||||0.37|||||||ANOVA|||||||0.37
91662378|NCT04614168|183220662|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91662379|NCT04614168|183220663|SUPERIORITY|||||||0.2|||||||ANOVA|||||||0.20
91662380|NCT04614168|183220663|SUPERIORITY|||||||0.95|||||||ANOVA|||||||0.95
91662381|NCT04614168|183220664|SUPERIORITY|||||||0.58|||||||ANOVA|||||||0.58
91662382|NCT04614168|183220664|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
91662383|NCT04614168|183220665|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91662384|NCT04614168|183220665|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91662385|NCT04614168|183220666|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91662386|NCT04614168|183220666|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91662387|NCT04614168|183220667|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91625116|NCT02259127|183142447|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.126|||=|0.004|TWO_SIDED|95.0|-0.21|-0.036|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 295~Analysis Specification: Pre-specified"||-0.036|-0.21|= 0.004
91662388|NCT04614168|183220667|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91662389|NCT04614168|183220668|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91662390|NCT04614168|183220668|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
91662391|NCT04614168|183220669|SUPERIORITY|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||||||0.0094
91791965|NCT00095238|183461652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.3|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||Comparison of 2 treatment arms at Month 6 (first 2 columns)||1.3|-0.8|
91662392|NCT04614168|183220670|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||||||>0.99
91662393|NCT04614168|183220670|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
91662394|NCT04614168|183220671|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91662395|NCT04614168|183220671|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91662396|NCT04614168|183220672|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Behaviour subscale||||0.25
91662397|NCT04614168|183220672|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Worry subscale||||0.63
91662398|NCT04614168|183220672|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||Behaviour subscale||||0.35
91662399|NCT04614168|183220672|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Worry subscale||||0.09
91662400|NCT04614168|183220673|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91662401|NCT04614168|183220673|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91662402|NCT04614168|183220674|SUPERIORITY|||||||0.77||||||Column factor p-value.|ANOVA|||||||0.77
91662403|NCT04614168|183220674|SUPERIORITY|||||||0.37|||||||ANOVA|||||||0.37
91662404|NCT04614168|183220675|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Trail making A delta clamp 1 compared to clamp 2||||0.88
91662405|NCT04614168|183220675|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Trail Making B delta clamp 1 compared to clamp 2||||0.69
91662406|NCT04614168|183220675|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Trail making A delta clamp 1 compared to clamp 2||||0.41
91662407|NCT04614168|183220675|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Trail making B delta clamp 1 compared to clamp 2||||0.49
91662408|NCT04614168|183220676|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Digit span forwards||||0.5
91662409|NCT04614168|183220676|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Digit span backwards||||0.5
91662410|NCT04614168|183220676|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Digit span forwards||||0.53
91662411|NCT04614168|183220676|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91662412|NCT04614168|183220677|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91662413|NCT04614168|183220677|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91662414|NCT04614168|183220678|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91662415|NCT04614168|183220678|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.27
91662416|NCT02777580|183220679|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
91662417|NCT02777580|183220680|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.62|1.48||||||||1.48|0.62|
91662418|NCT02777580|183220681|OTHER||Risk Ratio (RR)|4.57|||||TWO_SIDED|95.0|0.58|35.8||||||||35.8|0.58|
91662419|NCT02777580|183220682|OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|0.25|6.48||||||||6.48|0.25|
91662420|NCT00840476|183220685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.26||||||90.0|93.12|107.95|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.95|93.12|
91662421|NCT00840476|183220686|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|105.14||||||90.0|100.27|110.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.25|100.27|
91662422|NCT00840476|183220687|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|104.33||||||90.0|99.16|109.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.76|99.16|
91662423|NCT00908128|183220688|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.96||||||90.0|82.4|100.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.41|82.40|
91625117|NCT02259127|183142447|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.023|||=|0.547|TWO_SIDED|95.0|-0.096|0.056|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 382~Analysis Specification: Pre-specified"||0.056|-0.096|= 0.547
91662424|NCT00908128|183220689|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.16||||||90.0|96.24|102.16|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.16|96.24|
91662425|NCT00908128|183220690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.78||||||90.0|95.76|101.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.89|95.76|
91662426|NCT03261167|183220691|OTHER||Difference|18.1|||||TWO_SIDED|95.0|1.1|35.0||||||||35.0|1.1|
91662427|NCT03261167|183220692|OTHER||Adjusted rate difference|33.1|||||TWO_SIDED|95.0|17.0|49.2|||||Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||49.2|17.0|
91662428|NCT03261167|183220692|OTHER||Adjusted rate difference|21.7|||||TWO_SIDED|95.0|4.9|38.5|||||Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||38.5|4.9|
91662429|NCT03261167|183220692|OTHER||Adjusted rate difference|18.4|||||TWO_SIDED|95.0|1.3|35.5|||||Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||35.5|1.3|
91662430|NCT03261167|183220692|OTHER||Adjusted rate difference|12.9|||||TWO_SIDED|95.0|-4.2|30.1|||||Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||30.1|-4.2|
91481933|NCT02821910|182837793|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.67|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.44|104.68|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.68|87.44|
91481934|NCT02821910|182837793|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.47|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|92.12|105.25|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.25|92.12|
91662431|NCT03261167|183220692|OTHER||Adjusted rate difference|-5.6|||||TWO_SIDED|95.0|-20.9|9.8|||||Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||9.8|-20.9|
91662432|NCT03261167|183220692|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-23.0|5.9|||||Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||5.9|-23.0|
91662433|NCT03261167|183220692|OTHER||Adjusted rate difference|-12.1|||||TWO_SIDED|95.0|-27.5|3.2|||||Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.2|-27.5|
91662434|NCT03261167|183220692|OTHER||Adjusted rate difference|-9.6|||||TWO_SIDED|95.0|-27.2|7.9|||||Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||7.9|-27.2|
91662435|NCT03261167|183220692|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-21.9|4.7|||||Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||4.7|-21.9|
91527768|NCT03560258|182930592|SUPERIORITY|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.137
91662436|NCT03261167|183220692|OTHER||Adjusted rate difference|-10.4|||||TWO_SIDED|95.0|-24.3|3.4|||||Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.4|-24.3|
91662437|NCT03261167|183220692|OTHER||Adjusted rate difference|-8.9|||||TWO_SIDED|95.0|-23.8|6.0|||||Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.0|-23.8|
91662438|NCT03261167|183220692|OTHER||Adjusted rate difference|-0.1|||||TWO_SIDED|95.0|-17.7|17.4|||||Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.4|-17.7|
91662439|NCT03261167|183220692|OTHER||Adjusted rate difference|-9.9|||||TWO_SIDED|95.0|-26.4|6.5|||||Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.5|-26.4|
91662440|NCT03261167|183220692|OTHER||Adjusted rate difference|-6.7|||||TWO_SIDED|95.0|-23.6|10.3|||||Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||10.3|-23.6|
91662441|NCT03261167|183220692|OTHER||Adjusted rate difference|-1.5|||||TWO_SIDED|95.0|-18.8|15.7|||||Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||15.7|-18.8|
91662442|NCT03261167|183220692|OTHER||Adjusted rate difference|-0.5|||||TWO_SIDED|95.0|-18.8|17.9|||||Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.9|-18.8|
91662443|NCT03261167|183220693|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.75|-0.22|||||Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.22|-0.75|
91662444|NCT03261167|183220693|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-0.71|-0.13|||||Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.13|-0.71|
91481935|NCT02821910|182837794|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|94.94|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|86.6|104.08|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.08|86.60|
91527769|NCT03560258|182930592|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.014
91625118|NCT02259127|183142462|SUPERIORITY||Mean Difference (Final Values)|1.0|||=|0.004|TWO_SIDED|95.0|0.3|1.7|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.7|0.3|= 0.004
91625119|NCT02259127|183142462|SUPERIORITY||Mean Difference (Final Values)|1.4|||=|0.024|TWO_SIDED|95.0|0.2|2.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||2.5|0.2|= 0.024
91625120|NCT02259127|183142462|SUPERIORITY||Mean Difference (Final Values)|0.8|||=|0.075|TWO_SIDED|95.0|-0.1|1.6|||Regression, Linear|||"Statistical Analysis Title: Adjusting Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.6|-0.1|= 0.075
91625121|NCT02259127|183142462|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.8|0.5|||Regression, Linear|||||0.5|-0.8|0.67
91625122|NCT02259127|183142463|SUPERIORITY||Mean Difference (Final Values)|0.13|||=|0.036|TWO_SIDED|95.0|0.01|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.25|0.01|= 0.036
91625123|NCT02259127|183142463|SUPERIORITY||Mean Difference (Final Values)|0.17|||=|0.092|TWO_SIDED|95.0|-0.03|0.36|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||0.36|-0.03|=0.092
91625124|NCT02259127|183142463|SUPERIORITY||Mean Difference (Final Values)|0.1|||=|0.176|TWO_SIDED|95.0|-0.05|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.25|-0.05|=0.176
91625125|NCT02259127|183142463|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5|TWO_SIDED|95.0|-1.1|0.5|||Regression, Linear|||||0.5|-1.1|0.50
91625126|NCT00719862|183142464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_DEVIATION|0.3782||0.005||95.0|-1.8|-0.31|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.31|-1.80|0.005
91625127|NCT00719862|183142465|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.2987|STANDARD_DEVIATION|0.1881||0.112||95.0|-0.67|0.07|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.07|-0.67|0.112
91625128|NCT00719862|183142466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8617|STANDARD_DEVIATION|0.3803||0.023||95.0|-1.61|-0.12|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.12|-1.61|0.023
91625129|NCT00719862|183142467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7395|STANDARD_DEVIATION|0.3305||0.025||95.0|-1.39|-0.09|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||-0.09|-1.39|0.025
91625130|NCT00719862|183142468|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANOVA|||Change from baseline||||0.051
91625131|NCT01998269|183142470|SUPERIORITY_OR_OTHER||correlation coefficient|0.6|||<|0.001|TWO_SIDED||||||Correlation||r= 0.60, p-value\<0.001. P values below 0.05 are considered statistically significant in this study.|We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.||||<.001
91625132|NCT00107172|183142493|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.01||||0.98|TWO_SIDED|95.0|0.51|1.98|||Log Rank|Competing risk P-value = 0.91.||The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.||1.98|0.51|0.98
91625133|NCT00107172|183142494|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.07||||0.75|TWO_SIDED|95.0|0.71|1.61|||Log Rank|||||1.61|0.71|0.75
91625134|NCT00107172|183142499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.||||0.37
91625135|NCT00107172|183142499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.||||0.25
91625136|NCT00107172|183142500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.||||0.35
91625137|NCT00107172|183142500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.||||0.31
91625138|NCT00107172|183142503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.03
91625139|NCT00107172|183142503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.18
91481936|NCT02821910|182837794|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|106.63|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|100.65|112.96|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.96|100.65|
91662445|NCT03261167|183220693|OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-0.71|-0.04|||||Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.71|
91662446|NCT03261167|183220693|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.51|-0.02|||||Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.02|-0.51|
91662447|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.27|0.42|||||Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.42|-0.27|
91662448|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.25|0.46|||||Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.46|-0.25|
91527770|NCT03560258|182930592|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.100
91625140|NCT00107172|183142504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.38
91625141|NCT00107172|183142504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.16
91625142|NCT04268303|183142505|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91625143|NCT04268303|183142505|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91625144|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
91625145|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
91625146|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
91625147|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
91625148|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
91625149|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
91625150|NCT04268303|183142506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||<0.0001
91625151|NCT04268303|183142506|SUPERIORITY|||||||0.0075|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0075
91625152|NCT04268303|183142506|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0032
91625153|NCT04268303|183142506|SUPERIORITY|||||||0.4097|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.4097
91625154|NCT04268303|183142506|SUPERIORITY|||||||0.0457|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 10 minutes post-dose||||0.0457
91625155|NCT04268303|183142506|SUPERIORITY|||||||0.972|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 10 minutes post-dose||||0.9720
91625156|NCT03706040|183142521|SUPERIORITY||Adjusted Difference|13.0||||0.084|TWO_SIDED|95.0|-1.7|27.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||27.7|-1.7|0.084
91625157|NCT03706040|183142521|SUPERIORITY||Adjusted Difference|10.0||||0.179|TWO_SIDED|95.0|-4.6|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.6|-4.6|0.179
91625158|NCT03706040|183142522|SUPERIORITY||Adjusted Difference|8.7||||0.129|TWO_SIDED|95.0|-2.5|20.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||20.0|-2.5|0.129
91625159|NCT03706040|183142522|SUPERIORITY||Adjusted Difference|0.0||||0.994|TWO_SIDED|95.0|-9.4|9.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||9.4|-9.4|0.994
91625160|NCT03706040|183142523|SUPERIORITY||Adjusted Difference|13.7||||0.001|TWO_SIDED|95.0|5.4|22.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||22.1|5.4|0.001
91662449|NCT03261167|183220693|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.33|||||Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.33|-0.37|
91662450|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.19|0.38|||||Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.19|
91662451|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.23|0.43|||||Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.43|-0.23|
91625161|NCT03706040|183142523|SUPERIORITY||Adjusted Difference|15.3|||<|0.001|TWO_SIDED|95.0|6.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.0|6.6|<0.001
91481937|NCT02821910|182837794|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.41|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|94.54|106.64|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.64|94.54|
91481938|NCT02821910|182837795|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.97|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|91.46|104.94|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.94|91.46|
91625162|NCT03706040|183142524|SUPERIORITY||Least Squares (LS) Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.073||0.353|TWO_SIDED|95.0|-32.25|11.61|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||11.61|-32.25|0.353
91625163|NCT03706040|183142524|SUPERIORITY||LS Mean Difference|-16.86|STANDARD_ERROR_OF_MEAN|11.305||0.139|TWO_SIDED|95.0|-39.24|5.53|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||5.53|-39.24|0.139
91625164|NCT03706040|183142527|SUPERIORITY||Adjusted Difference|12.9||||0.171|TWO_SIDED|95.0|-5.6|31.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.4|-5.6|0.171
91625165|NCT03706040|183142527|SUPERIORITY||Adjusted Difference|5.7||||0.552|TWO_SIDED|95.0|-13.1|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.5|-13.1|0.552
91625166|NCT03706040|183142529|SUPERIORITY||Adjusted Difference|11.6||||0.022|TWO_SIDED|95.0|1.7|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||21.6|1.7|0.022
91481939|NCT02821910|182837795|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.04|STANDARD_DEVIATION|17.9|||TWO_SIDED|90.0|90.23|110.91|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.91|90.23|
91481940|NCT02821910|182837795|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.24|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.58|108.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||108.38|94.58|
91625167|NCT03706040|183142529|SUPERIORITY||Adjusted Difference|5.8||||0.192|TWO_SIDED|95.0|-2.9|14.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||14.4|-2.9|0.192
91625168|NCT03706040|183142532|SUPERIORITY||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|4.506||0.169|TWO_SIDED|95.0|-15.15|2.68|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.68|-15.15|0.169
91662452|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.17|0.52|||||Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.52|-0.17|
91662453|NCT03261167|183220693|OTHER||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.2|0.48|||||Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.48|-0.20|
91662454|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.34|||||Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.34|-0.25|
91662455|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-0.08|0.63|||||Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.63|-0.08|
91662456|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.23|0.51|||||Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.51|-0.23|
91662457|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.33|0.38|||||Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.33|
91662458|NCT03261167|183220693|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.31|0.47|||||Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.47|-0.31|
91662459|NCT03261167|183220694|OTHER||Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.48|0.0|||||Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.00|-0.48|
91662460|NCT03261167|183220694|OTHER||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.42|0.09|||||Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.09|-0.42|
91625169|NCT03706040|183142532|SUPERIORITY||LS Mean Difference|-5.86|STANDARD_ERROR_OF_MEAN|4.589||0.204|TWO_SIDED|95.0|-14.94|3.22|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.22|-14.94|0.204
91625170|NCT03706040|183142534|SUPERIORITY||Adjusted Difference|6.7||||0.422|TWO_SIDED|95.0|-9.7|23.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||23.1|-9.7|0.422
91625171|NCT03706040|183142534|SUPERIORITY||Adjusted Difference|-5.2||||0.505|TWO_SIDED|95.0|-20.3|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||10.0|-20.3|0.505
91625172|NCT03706040|183142536|SUPERIORITY||Adjusted Difference|10.1||||0.005|TWO_SIDED|95.0|3.0|17.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||17.3|3.0|0.005
91625173|NCT03706040|183142536|SUPERIORITY||Adjusted Difference|2.9||||0.151|TWO_SIDED|95.0|-1.1|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||6.8|-1.1|0.151
91625174|NCT03706040|183142538|SUPERIORITY||Adjusted Difference|5.9||||0.035|TWO_SIDED|95.0|0.4|11.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.3|0.4|0.035
91625175|NCT03706040|183142538|SUPERIORITY||Adjusted Difference|1.5||||0.311|TWO_SIDED|95.0|-1.4|4.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||4.4|-1.4|0.311
91625176|NCT03706040|183142540|SUPERIORITY||Adjusted Difference|-0.3||||0.965|TWO_SIDED|95.0|-12.0|11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.5|-12.0|0.965
91625177|NCT03706040|183142540|SUPERIORITY||Adjusted Difference|-3.1||||0.583|TWO_SIDED|95.0|-14.3|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||8.1|-14.3|0.583
91625178|NCT03706040|183142544|SUPERIORITY||Adjusted Difference|5.9||||0.539|TWO_SIDED|95.0|-13.0|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.9|-13.0|0.539
91625179|NCT03706040|183142544|SUPERIORITY||Adjusted Difference|12.2||||0.213|TWO_SIDED|95.0|-7.0|31.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.5|-7.0|0.213
91662461|NCT03261167|183220694|OTHER||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.37|0.08|||||Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.08|-0.37|
91662462|NCT03261167|183220694|OTHER||Mean Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.52|-0.04|||||Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.52|
91662463|NCT00835146|183220704|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.9||||||90.0|91.8|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|91.8|
91662464|NCT00835146|183220705|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|93.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|93.3|
91791966|NCT00095238|183461652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||comparison of 2 treatment arms at Month 14 (columns 3 and 4)||1.7|-0.5|
91625180|NCT03706040|183142546|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.82||0.988|TWO_SIDED|95.0|-3.6|3.6|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.6|-3.6|0.988
91625181|NCT03706040|183142546|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.86||0.594|TWO_SIDED|95.0|-4.7|2.7|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.7|-4.7|0.594
91625182|NCT03706040|183142550|SUPERIORITY||LS Mean Difference|-1.318|STANDARD_ERROR_OF_MEAN|0.6137||0.033|TWO_SIDED|95.0|-2.531|-0.105|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.105|-2.531|0.033
91625183|NCT03706040|183142550|SUPERIORITY||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|0.626||0.009|TWO_SIDED|95.0|-2.885|-0.411|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.411|-2.885|0.009
91527771|NCT03560258|182930594|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
91625184|NCT00439725|183142554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.185|STANDARD_ERROR_OF_MEAN|0.3858|<|0.0001||95.0|0.087|0.393||1st test in a hierarchy, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing).||0.393|0.087|< 0.0001
91625185|NCT00439725|183142555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|STANDARD_ERROR_OF_MEAN|0.385|<|0.0001||95.0|0.085|0.383||2nd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the 1st test in hierarchy was significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.383|0.085|< 0.0001
91625186|NCT00439725|183142556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.198|STANDARD_ERROR_OF_MEAN|0.3659|<|0.0001||95.0|0.096|0.405||3rd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.405|0.096|< 0.0001
91625187|NCT00439725|183142557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.278|STANDARD_ERROR_OF_MEAN|0.3274|<|0.0001||95.0|0.146|0.528||4th test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.528|0.146|< 0.0001
91625188|NCT00439725|183142560|SUPERIORITY_OR_OTHER|||||||0.1121||||||No adjustment for multiple comparison.|Log Rank|||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||||0.1121
91625189|NCT00439725|183142561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.185|STANDARD_ERROR_OF_MEAN|0.4131|<|0.0001||95.0|2.307|11.652||No adjustment for multiple comparison, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment done for treatment-emergent (time window: 2 days)||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||11.652|2.307|< 0.0001
91625190|NCT01673490|183142656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91625191|NCT01673490|183142657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 3|t-test, 2 sided|||||||<0.001
91625192|NCT01673490|183142657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 6|t-test, 2 sided|||||||<0.001
91625193|NCT00379236|183142659|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|Screening pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.008
91625194|NCT00379236|183142660|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is purely nominal|ANCOVA|||||||0.001
91625195|NCT00379236|183142661|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Chi-squared|||||||0.202
91625196|NCT00379236|183142662|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Chi-squared|||||||0.047
91625197|NCT00379236|183142663|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Chi-squared|||||||0.618
91662465|NCT04813354|183220719|SUPERIORITY||Odds Ratio (OR)|0.11|||<|0.001|TWO_SIDED|95.0|0.01|0.4|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.40|0.01|<0.001
91527772|NCT03560258|182930594|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
91625198|NCT00379236|183142664|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Chi-squared|||||||0.028
91625199|NCT00379236|183142665|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|Baseline pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.002
91625200|NCT00379236|183142676|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
91625201|NCT02940860|183142686|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.06|0.23|||||The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.23|-0.06|
91625202|NCT02940860|183142687|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.86||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.86|0.06|
91625203|NCT02940860|183142687|OTHER||Risk Difference (RD)|0.29|||||TWO_SIDED|95.0|-0.19|0.77||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.77|-0.19|
91625204|NCT02940860|183142687|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
91481941|NCT02821910|182837796|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.5|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.94|105.71|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.71|89.94|
91481942|NCT02821910|182837796|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|117.31|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|103.41|133.07|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||133.07|103.41|
91527773|NCT03560258|182930594|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||1.00
91625205|NCT02940860|183142688|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.0248
91625206|NCT02940860|183142689|SUPERIORITY|||||||0.0185|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.0185
91625207|NCT02940860|183142691|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0478|TWO_SIDED|95.0|1.0|1.87|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥1 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.87|1.00|0.0478
91625208|NCT02940860|183142691|SUPERIORITY||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.39|2.36|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥1 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||2.36|1.39|<0.0001
91625209|NCT02940860|183142691|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0048|TWO_SIDED|95.0|1.11|1.79|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥1 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.79|1.11|0.0048
91625210|NCT02940860|183142691|SUPERIORITY||Odds Ratio (OR)|1.01||||0.944|TWO_SIDED|95.0|0.8|1.27|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥1 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.27|0.80|0.9440
91625211|NCT02940860|183142692|SUPERIORITY|||||||0.0174|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0174
91625212|NCT02940860|183142693|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5074|TWO_SIDED|95.0|0.83|1.45|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.45|0.83|0.5074
91625213|NCT02940860|183142694|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1035|TWO_SIDED|95.0|0.96|1.6|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.60|0.96|0.1035
91625214|NCT02940860|183142695|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.38|2.4|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||2.40|1.38|<0.0001
91625215|NCT02940860|183142696|SUPERIORITY||Mean Difference (Final Values)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.31|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.31|0.12|<0.0001
91625216|NCT02940860|183142696|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.14|0.36|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.36|0.14|<0.0001
91625217|NCT02940860|183142696|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0208|TWO_SIDED|95.0|0.02|0.28|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.28|0.02|0.0208
91527482|NCT02597933|182930140|OTHER||Mean Difference (Final Values)|40.98||||0.0349|TWO_SIDED|95.0|2.92|79.04|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept||79.04|2.92|0.0349
91625218|NCT02940860|183142697|SUPERIORITY||Mean Difference (Final Values)|309.2|||<|0.0001|TWO_SIDED|95.0|280.7|337.8|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||337.8|280.7|<0.0001
91662466|NCT04813354|183220721|OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.03|0.74|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.74|0.03|0.005
91662467|NCT04813354|183220730|OTHER||Mean Difference (Final Values)|27.63|||<|0.001|TWO_SIDED|95.0|21.31|33.96|||Paired samples t-test|||||33.96|21.31|<0.001
91662468|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-1.09|||<|0.0001||95.0|-1.3|-0.88|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.88|-1.30|<0.0001
91662469|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.02|||<|0.0001||95.0|-0.19|0.15|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.15|-0.19|<0.0001
91662470|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.06|||<|0.0001||95.0|-1.27|-0.85|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.85|-1.27|<0.0001
91662471|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.01|||<|0.0001||95.0|-0.16|0.18|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.18|-0.16|<0.0001
91662472|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.78|||<|0.0001||95.0|-0.99|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-0.99|<0.0001
91662473|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.29||||0.1026||95.0|0.12|0.46|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.46|0.12|0.1026
91662474|NCT00318461|183220741|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.07|||<|0.0001||95.0|-1.28|-0.86|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.86|-1.28|<0.0001
91625219|NCT02940860|183142697|SUPERIORITY||Mean Difference (Final Values)|95.8|||<|0.0001|TWO_SIDED|95.0|67.9|123.7|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||123.7|67.9|<0.0001
91625220|NCT02940860|183142697|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.7834|TWO_SIDED|95.0|-21.2|28.1|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||28.1|-21.2|0.7834
91662475|NCT00318461|183220742|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.29||||0.0016||95.0|-2.16|-0.41|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.41|-2.16|0.0016
91662476|NCT00318461|183220742|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.75|||<|0.0001||95.0|-4.48|-3.01|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-3.01|-4.48|<0.0001
91481943|NCT02821910|182837796|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|102.74|STANDARD_DEVIATION|6.2|||TWO_SIDED|90.0|98.56|107.1|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.10|98.56|
91481944|NCT02821910|182837797|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.34|STANDARD_DEVIATION|6.6|||TWO_SIDED|90.0|92.13|100.75|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.75|92.13|
91625221|NCT02940860|183142697|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.7621|TWO_SIDED|95.0|-18.1|24.7|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||24.7|-18.1|0.7621
91625222|NCT02940860|183142698|SUPERIORITY||Mean Difference (Final Values)|8.8|||<|0.0001|TWO_SIDED|95.0|6.9|10.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||10.7|6.9|<0.0001
91625223|NCT02940860|183142698|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.0129|TWO_SIDED|95.0|0.3|2.4|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.4|0.3|0.0129
91625224|NCT02940860|183142698|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.2403|TWO_SIDED|95.0|-0.4|1.5|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.5|-0.4|0.2403
91625225|NCT02940860|183142698|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8094|TWO_SIDED|95.0|-0.9|1.2|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.2|-0.9|0.8094
91481945|NCT02821910|182837797|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.07|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|99.95|110.45|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.45|99.95|
91527483|NCT02597933|182930141|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.37||0.5785|TWO_SIDED|95.0|-0.94|0.53|||MMRM|||The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||0.53|-0.94|0.5785
91481946|NCT02821910|182837797|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.31|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|96.41|104.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.38|96.41|
91481947|NCT02821910|182837798|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.63|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|92.86|100.54|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.54|92.86|
91481948|NCT02821910|182837798|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.87|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|97.96|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|97.96|
91481949|NCT02821910|182837798|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.75|STANDARD_DEVIATION|6.0|||TWO_SIDED|90.0|95.81|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|95.81|
91525156|NCT01874145|182925638|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.337|0.742||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.742|0.337|0.0006
91525157|NCT01874145|182925639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.058|STANDARD_ERROR_OF_MEAN|1.206||0.0897|TWO_SIDED|95.0|-4.438|0.322||The overall significance level for this study was 5% using 2-tailed test.|ANCOVA|In addition to treatment group, month (categorical), treatment-by-month interaction and score at baseline were used as covariates.|GA 40 mg/mL TIW treatment group vs. GA 20 mg/mL QD treatment group.|"To control for type 1 errors, secondary variables were analyzed only if analysis of the primary variable was statistically significant. Gate-keeping procedures offered further control with this hierarchy:~1. the rate of ISRs~2. change from baseline to month 4 (change - M4) in MSIS-20 physical wellbeing~3. change - M4 in MSIS-20 psychological wellbeing~4. change - M4 in TSQM-9 convenience~5. change - M4 in TSQM-9 overall satisfaction"||0.322|-4.438|0.0897
91481950|NCT02821910|182837799|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.57|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|90.94|102.56|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.56|90.94|
91481951|NCT02821910|182837799|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.4|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|87.5|104.01|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.01|87.50|
91625226|NCT02940860|183142699|SUPERIORITY||Mean Difference (Final Values)|26.5|||<|0.0001|TWO_SIDED|95.0|20.4|32.7|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||32.7|20.4|<0.0001
91662477|NCT00318461|183220742|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.07||||0.0117||95.0|-1.94|-0.19|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.19|-1.94|0.0117
91791967|NCT06460493|183461691|OTHER|The proportion of subjects classified as responders at week 12, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|67.0|||||TWO_SIDED|95.0|38.0|100.0|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||100.0|38.0|
91662478|NCT00318461|183220742|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.53|||<|0.0001||95.0|-4.27|-2.79|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.79|-4.27|<0.0001
91662479|NCT00318461|183220742|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.8198||95.0|-1.15|0.6|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.60|-1.15|0.8198
91662480|NCT00318461|183220742|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.73|||<|0.0001||95.0|-3.47|-2.0|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.00|-3.47|<0.0001
91662481|NCT00318461|183220743|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.11||||0.0378||95.0|-2.18|-0.05|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.05|-2.18|0.0378
91662482|NCT00318461|183220743|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.61|||<|0.0001||95.0|-4.51|-2.72|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.72|-4.51|<0.0001
91662483|NCT00318461|183220743|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.23||||0.0185||95.0|-2.3|-0.16|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.16|-2.30|0.0185
91662484|NCT00318461|183220743|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.73|||<|0.0001||95.0|-4.64|-2.83|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.83|-4.64|<0.0001
91662485|NCT00318461|183220743|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.27||||0.9069||95.0|-1.33|0.8|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.80|-1.33|0.9069
91662486|NCT00318461|183220743|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.77|||<|0.0001||95.0|-3.67|-1.87|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.87|-3.67|<0.0001
91791968|NCT06460493|183461692|OTHER|The proportion of subjects classified as responders at week 6, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|44.4|||||TWO_SIDED|95.0|22.0|89.5|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||89.5|22.0|
91481952|NCT02821910|182837799|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.45|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|92.44|104.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.85|92.44|
91481953|NCT02821910|182837800|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.08|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|87.36|103.48|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.48|87.36|
91625227|NCT02940860|183142699|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.2229|TWO_SIDED|95.0|-1.2|5.1|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||5.1|-1.2|0.2229
91625228|NCT02940860|183142699|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.9046|TWO_SIDED|95.0|-2.9|2.6|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.6|-2.9|0.9046
91625229|NCT02940860|183142699|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.1307|TWO_SIDED|95.0|-5.8|0.8|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||0.8|-5.8|0.1307
91625230|NCT02940860|183142700|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8196|TWO_SIDED|95.0|-0.73|0.92|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.92|-0.73|0.8196
91625231|NCT02940860|183142700|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.7132|TWO_SIDED|95.0|-1.06|0.73|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.73|-1.06|0.7132
91625232|NCT02940860|183142700|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.586|TWO_SIDED|95.0|-0.71|1.25|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||1.25|-0.71|0.5860
91625233|NCT04914819|183142706|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.048|TWO_SIDED|95.0|0.04|10.8|||Mixed Models Analysis|||Change in weight among participants who completed final assessment||10.8|0.04|0.048
91662487|NCT00318461|183220744|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.09|||<|0.0001||95.0|-2.68|-1.5|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.50|-2.68|<0.0001
91481954|NCT02821910|182837800|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.72|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|98.78|113.15|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||113.15|98.78|
91525158|NCT00402337|182925651|SUPERIORITY_OR_OTHER|||||||0.0337||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0337
91525159|NCT00402337|182925651|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0010
91625234|NCT04914819|183142707|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.3
91625235|NCT04914819|183142708|SUPERIORITY|||||||0.331|||||||Chi-squared|||||||0.331
91625236|NCT04914819|183142709|SUPERIORITY|||||||0.734|||||||Fisher Exact|||||||0.734
91625237|NCT03961295|183142713|OTHER||Ratio of Geometric LSMs|1.2984|||||TWO_SIDED|90.0|1.0786|1.5486||||||Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5486|1.0786|
91625238|NCT03961295|183142714|OTHER||Ratio of Geometric LSMs|1.3274|||||TWO_SIDED|90.0|1.1147|1.5807||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5807|1.1147|
91625239|NCT03961295|183142715|OTHER||Ratio of Geometric LSMs|1.1978|||||TWO_SIDED|90.0|1.0394|1.3804||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.3804|1.0394|
91791969|NCT05204381|183461704|OTHER|||||||0.783|||||||ANOVA|F-statistic is 0.077||Mixed-factors ANOVA for the interaction between stimulation frequency (theta or alpha) and synchrony (in-phase or anti-phase).||||0.783
91791970|NCT05204381|183461705|OTHER|||||||0.965|||||||ANOVA|F-statistic is 0.002||Mixed-factors ANOVA for the interaction between stimulation frequency (theta or alpha) and synchrony (in-phase or anti-phase).||||0.965
91481955|NCT02821910|182837800|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.61|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|92.0|112.22|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.22|92.00|
91481956|NCT00423670|182837801|SUPERIORITY_OR_OTHER||Percent difference in SVR|16.7||||0.0126|TWO_SIDED|95.0|3.5|30.0|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||30|3.5|0.0126
91481957|NCT00423670|182837801|SUPERIORITY_OR_OTHER||Percent difference in SVR|18.8||||0.0048|TWO_SIDED|95.0|5.5|32.2|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||32.2|5.5|0.0048
91481958|NCT00423670|182837801|SUPERIORITY_OR_OTHER||Percent difference in SVR|29.5|||<|0.0001|TWO_SIDED|95.0|16.5|42.5|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||42.5|16.5|<0.0001
91481959|NCT00423670|182837801|SUPERIORITY_OR_OTHER||Percent difference in SVR|37.3|||<|0.0001|TWO_SIDED|95.0|24.7|49.8|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||49.8|24.7|<0.0001
91481960|NCT00423670|182837802|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|5.1||||0.2864|TWO_SIDED|95.0|-4.2|14.3|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||14.3|-4.2|0.2864
91481961|NCT00423670|182837803|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|15.6||||0.0009|TWO_SIDED|95.0|6.5|24.8|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||24.8|6.5|0.0009
91713910|NCT00643201|183319448|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.307|||<|0.0001|TWO_SIDED|95.0|0.1728|0.5452||p-value calculated on the CMH test stratified by index event strata.|Cochran-Mantel-Haenszel||Relative risk and CI were calculated based on CMH test stratified by index event strata.|Hypothesis: apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. As per the hierarchical statistical testing cascade, inferential testing for adjudicated major bleeding occurred because non-inferiority for VTE/VTE-related death (Primary efficacy endpoint) was demonstrated earlier. Rejection of the null hypothesis for equivalence for major bleeding allowed inferential testing for superiority of VTE/VTE-related death.||0.5452|0.1728|<0.0001
91481962|NCT02131532|182837812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.25|STANDARD_ERROR_OF_MEAN|3.321||0.03|TWO_SIDED|95.0|1.398|17.102|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in fatigue scores between baseline and three-month assessments||17.102|1.398|0.03
91481963|NCT02131532|182837813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.625|STANDARD_ERROR_OF_MEAN|1.401||0.1|TWO_SIDED|95.0|-0.687|5.937|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in depression scores between baseline and three-month assessments||5.937|-0.687|0.10
91481964|NCT02131532|182837814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.313||0.45|TWO_SIDED|95.0|-0.991|0.491|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in independence scores between baseline and three-month assessments||0.491|-0.991|0.45
91481965|NCT02131532|182837815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.875|STANDARD_ERROR_OF_MEAN|5.03||0.03|TWO_SIDED|95.0|-25.769|-1.981|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in scores of general rating of recovery between baseline and three-month assessments||-1.981|-25.769|0.03
91525160|NCT00402337|182925651|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
91791971|NCT05204381|183461706|OTHER|||||||0.089|||||||ANOVA|F-statistic is 3.046||Mixed-factors ANOVA for the interaction between stimulation frequency (theta or alpha) and synchrony (in-phase or anti-phase).||||0.089
91481966|NCT02131532|182837816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.781|STANDARD_ERROR_OF_MEAN|5.594||0.89|TWO_SIDED|95.0|-14.01|12.448|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in physical strength scores between baseline and three-month assessments||12.448|-14.010|0.89
91481967|NCT02131532|182837817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.105|STANDARD_ERROR_OF_MEAN|2.378||0.009|TWO_SIDED|95.0|-7.729|3.519|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in memory and thinking scores between baseline and three-month assessments||3.519|-7.729|0.009
91481968|NCT02131532|182837818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.403|STANDARD_ERROR_OF_MEAN|5.168||0.009|TWO_SIDED|95.0|-30.624|-6.183|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in emotion scores between baseline and three-month assessments||-6.183|-30.624|0.009
91481969|NCT02131532|182837819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.142|STANDARD_ERROR_OF_MEAN|3.696||0.1|TWO_SIDED|95.0|-15.883|1.598|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in communication scores between baseline and three-month assessments||1.598|-15.883|0.10
91481970|NCT02131532|182837820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.25||0.09|TWO_SIDED|95.0|-5.455|0.455|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in daily activities scores between baseline and three-month assessments||0.455|-5.455|0.09
91525161|NCT00402337|182925651|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
91481971|NCT02131532|182837821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.821|STANDARD_ERROR_OF_MEAN|1.382||0.03|TWO_SIDED|95.0|-7.091|-0.551|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in mobility scores between baseline and three-month assessments||-0.551|-7.091|0.03
91625240|NCT00962754|183142759|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority since our hypothesis was that there would be no difference in outcome between the intervention and the control group.|Adjusted ratio of geometric means|1.0|||<|0.05|TWO_SIDED|95.0|0.81|1.19||"log transformation of mean duration of hospitalization,difference between two groups expressed as ratio of geometric means for duration. 95% confidence intervals calculated using bootstrapping method.~correction by linear regression model"|t-test, 2 sided|||We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.||1.19|0.81|<0.05
91625241|NCT00438464|183142782|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91625242|NCT00438464|183142783|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
91625243|NCT00438464|183142784|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91625244|NCT00438464|183142785|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.805
91625245|NCT00438464|183142786|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
91625246|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within GG3||||0.70
91662488|NCT00318461|183220744|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.38||||0.1845||95.0|-0.87|0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.11|-0.87|0.1845
91791972|NCT00075270|183461718|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.142|TWO_SIDED|95.0|0.72|1.05||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio is based on the log-rank test.|||1.05|0.72|0.142
91527774|NCT03560258|182930595|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.678
91625247|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG3||||0.38
91625248|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG3||||0.41
91625249|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG3||||0.75
91625250|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3||||0.57
91625251|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3||||0.12
91625252|NCT00438464|183142787|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cleaved Caspase 3 (Caspase), Within GG3||||0.03
91625253|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Vascular Epithelial Growth Factor (VEGF3), Within GG4||||0.45
91625254|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG4||||0.83
91625255|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG4||||0.04
91625256|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG4||||0.80
91625257|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4||||0.61
91625258|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within GG4||||0.86
91625259|NCT00438464|183142788|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within GG4||||0.02
91625260|NCT00438464|183142793|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Finasteride Arm||||0.84
91625261|NCT00438464|183142793|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Finasteride Arm||||0.36
91625262|NCT00438464|183142793|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Finasteride||||0.09
91625263|NCT00438464|183142793|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Finasteride Arm||||0.46
91625264|NCT00438464|183142793|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Finasteride Arm||||0.88
91625265|NCT00438464|183142793|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Finasteride Arm||||0.18
91625266|NCT00438464|183142793|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Finasteride Arm||||<0.001
91625267|NCT00438464|183142794|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Placebo Arm||||0.32
91625268|NCT00438464|183142794|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Placebo Arm||||0.83
91625269|NCT00438464|183142794|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Placebo Arm||||0.77
91625270|NCT00438464|183142794|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Placebo Arm||||0.87
91625271|NCT00438464|183142794|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Placebo Arm||||0.91
91625272|NCT00438464|183142794|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Placebo Arm||||0.90
91625273|NCT00438464|183142794|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Placebo Arm||||<0.001
91481972|NCT02131532|182837822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.875|STANDARD_ERROR_OF_MEAN|3.264||0.58|TWO_SIDED|95.0|-9.594|5.844||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in hand function scores between baseline and three-month assessments||5.844|-9.594|0.58
91662489|NCT00318461|183220744|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.04|||<|0.0001||95.0|-2.63|-1.44|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.44|-2.63|<0.0001
91662490|NCT00318461|183220744|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.33||||0.3047||95.0|-0.82|0.17|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||0.17|-0.82|0.3047
91662491|NCT00318461|183220744|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.53|||<|0.0001||95.0|-2.12|-0.94|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.94|-2.12|<0.0001
91662492|NCT00318461|183220744|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.18||||0.8079||95.0|-0.32|0.67|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.67|-0.32|0.8079
91662493|NCT00318461|183220745|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.93|||<|0.0001||95.0|-2.58|-1.28|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.28|-2.58|<0.0001
91662494|NCT00318461|183220745|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.53||||0.0542||95.0|-1.08|0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.01|-1.08|0.0542
91662495|NCT00318461|183220745|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.30|-2.60|<0.0001
91662496|NCT00318461|183220745|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.55||||0.0451||95.0|-1.1|-0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||-0.01|-1.10|0.0451
91662497|NCT00318461|183220745|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.55|||<|0.0001||95.0|-2.2|-0.9|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.90|-2.20|<0.0001
91481973|NCT02131532|182837823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.576|STANDARD_ERROR_OF_MEAN|3.691||0.006|TWO_SIDED|95.0|-23.304|-5.847||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in social activity scores between baseline and three-month assessments||-5.847|-23.304|0.006
91662498|NCT00318461|183220745|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.9006||95.0|-0.7|0.39|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.39|-0.70|0.9006
91662499|NCT00318461|183220746|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.13||||0.8871||95.0|-0.62|0.36|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.36|-0.62|0.8871
91662500|NCT00318461|183220746|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.12||||0.8695||95.0|-0.51|0.27|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.27|-0.51|0.8695
91662501|NCT00318461|183220746|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.03||||0.9994||95.0|-0.46|0.52|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.52|-0.46|0.9994
91662502|NCT00318461|183220746|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.04||||0.9984||95.0|-0.35|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.35|0.9984
91662503|NCT00318461|183220746|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.6201||95.0|-0.28|0.7|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.70|-0.28|0.6201
91662504|NCT00318461|183220746|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.4831||95.0|-0.18|0.6|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.60|-0.18|0.4831
91662505|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.83|||<|0.0001||95.0|-1.07|-0.59|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.59|-1.07|<0.0001
91662506|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.08|||<|0.0001||95.0|-0.28|0.12|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.12|-0.28|<0.0001
91481974|NCT03583073|182837837|SUPERIORITY|||||||0.053|||||||Chi-squared, Corrected|DF = 1||||||.053
91481975|NCT03583073|182837838|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.072|TWO_SIDED|95.0|-0.18|4.06|||Chi-squared, Corrected|||||4.06|-0.18|.072
91481976|NCT01856023|182837843|SUPERIORITY|one -sample binomial test - 1-year estimated OS for these 28 patients was 75% (95%CI: 51%, 88%)||||||0.001||||||compared to the historical control rate of 46% one year survival|Log Rank|||OS rates of the Evaluable population in entire cohort was compared with the historical control rate of 46% (Hodi, et al NEJM 2010) using a one-sample binomial test due to early termination of enrollment without reaching target accrual; planned analysis to be the difference between treatment arms using log-rank test. One year OS along with 95% CI estimated for entire population and each treatment arm separately.||||.001
91481977|NCT00424255|182837847|SUPERIORITY_OR_OTHER|||||||0.2251||95.0||||The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.2251
91481978|NCT00424255|182837847|SUPERIORITY_OR_OTHER|||||||0.4502||95.0||||The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.4502
91481979|NCT00424255|182837847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.85|1.43|||||Hazard Ratios were estimated using a Pike estimator.|||1.43|0.85|
91625274|NCT03943446|183142795|SUPERIORITY||Estimated Difference in ER Rate|-0.1|||=|0.59|TWO_SIDED|95.0|-0.44|0.23|||Fisher Exact|||||0.23|-0.44|=0.590
91625275|NCT03943446|183142795|SUPERIORITY||Estimated difference in ERR|-0.01|||=|1|TWO_SIDED|95.0|-0.34|0.31|||Fisher Exact|||||0.31|-0.34|=1.000
91791973|NCT00075270|183461719|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.82||||0.094|TWO_SIDED|95.0|0.65|1.04||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio was based on the log-rank test.|||1.04|0.65|0.094
91481980|NCT01369485|182837938|SUPERIORITY_OR_OTHER|||||||0.3636|||||||Chi-squared|||The sample size calculation was determined using the 2-sided Chi-square test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥50% in mean urgency urinary incontinence episodes (leaks) between baseline and Week 12 of the study; (3) 20 % dropout rate.||||0.3636
91525162|NCT02707692|182925689|SUPERIORITY||Mean Difference (Final Values)|-988.0||||0.32|TWO_SIDED|95.0|-2996.3|1020.3|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||1020.3|-2996.3|0.32
91527775|NCT03560258|182930595|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.037
91625276|NCT02707601|183142801|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
91625277|NCT02707601|183142801|SUPERIORITY|||||||0.042||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.042
91625278|NCT02707601|183142802|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
91625279|NCT02707601|183142802|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
91791974|NCT00246571|183461738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.8885|TWO_SIDED|95.0|0.8889|1.628||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).|Log Rank|||For core radiology laboratory assessment||1.6280|0.8889|0.8885
91481981|NCT01369485|182837938|SUPERIORITY_OR_OTHER|||||||0.4849|||||||Chi-squared|||||||0.4849
91481982|NCT01369485|182837939|SUPERIORITY_OR_OTHER|||||||0.2893|||||||Wilcoxon (Mann-Whitney)|||||||0.2893
91481983|NCT01369485|182837939|SUPERIORITY_OR_OTHER|||||||0.3223|||||||Wilcoxon (Mann-Whitney)|||||||0.3223
91481984|NCT01369485|182837940|SUPERIORITY_OR_OTHER|||||||0.3387|||||||Wilcoxon (Mann-Whitney)|||||||0.3387
91481985|NCT01369485|182837941|SUPERIORITY_OR_OTHER|||||||0.6557|||||||Wilcoxon (Mann-Whitney)|||||||0.6557
91481986|NCT01369485|182837942|SUPERIORITY_OR_OTHER|||||||0.4354|||||||Wilcoxon (Mann-Whitney)|||||||0.4354
91481987|NCT01369485|182837943|SUPERIORITY_OR_OTHER|||||||0.9918|||||||Wilcoxon (Mann-Whitney)|||||||0.9918
91481988|NCT01369485|182837943|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||||||0.3770
91481989|NCT01369485|182837944|SUPERIORITY_OR_OTHER|||||||0.4147|||||||Fisher Exact|||||||0.4147
91481990|NCT01369485|182837944|SUPERIORITY_OR_OTHER|||||||0.0877|||||||Fisher Exact|||||||0.0877
91625280|NCT02707601|183142803|OTHER||Difference in Percentages|0.0||||1|TWO_SIDED|95.0|-6.1|6.1|||Fisher exact test||The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.1|-6.1|1.00
91625281|NCT00223652|183142805|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||=.001
91625282|NCT00223652|183142805|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
91625283|NCT00223652|183142805|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
91625284|NCT00223652|183142806|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
91625285|NCT00223652|183142807|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
91625286|NCT00223652|183142807|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Mixed Models Analysis|||||||0.61
91625287|NCT00223652|183142807|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
91625288|NCT00223652|183142808|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Generalized estimating equations models|||||||<0.0001
91625289|NCT00223652|183142808|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Generalized estimating equations models|||||||0.12
91625290|NCT00223652|183142808|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Generalized estimating equations models|||||||0.86
91625291|NCT00223652|183142809|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
91625292|NCT00223652|183142810|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Generalized estimating equations models|||||||>0.37
91625293|NCT03004976|183142815|OTHER||Wilcoxon Mann-Whitney Odds|0.9|STANDARD_ERROR_OF_MEAN|0.248||0.71|TWO_SIDED|95.0|0.53|1.55||Wilcoxon Two Sample Test|Wilcoxon (Mann-Whitney)|||Primary efficacy analysis (mRS shift from baseline to 90 days)||1.55|0.53|0.71
91625294|NCT03004976|183142815|OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.223||0.87|TWO_SIDED|95.0|0.4|2.3|||Cumulative Logit Proportional Odds Model|||Additional analysis of the primary endpoint (mRS score at 90 days), adjusted for baseline mRS, baseline NIHSS, and institution.||2.3|0.4|0.87
91713911|NCT00643201|183319449|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.3566|0.5453||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing was not conducted because the null hypothesis pertaining to superiority for VTE/VTE-related death was not rejected.||0.5453|0.3566|<0.0001
91791975|NCT00246571|183461738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1598||||0.8472|TWO_SIDED|95.0|0.8703|1.5457||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.|Log Rank|||For investigator's assessment||1.5457|0.8703|0.8472
91525163|NCT02707692|182925689|SUPERIORITY||Mean Difference (Final Values)|-405.0||||0.31|TWO_SIDED|95.0|-1199.7|389.7|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||389.7|-1199.7|0.31
91625295|NCT02781454|183142846|SUPERIORITY||linear contrast active vs placebo|-5.558||||0.039|TWO_SIDED|95.0|-10.8|-0.315|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||-0.315|-10.80|0.039
91625296|NCT02781454|183142847|SUPERIORITY||linear contrast active vs placebo|0.792||||0.332|TWO_SIDED|95.0|0.484|1.296||linear contrast active vs placebo|Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.296|0.484|0.332
91625297|NCT02781454|183142848|SUPERIORITY||linear contrast active vs placebo|0.411||||0.013|TWO_SIDED|95.0|0.208|0.81|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||0.810|0.208|0.013
91625298|NCT02781454|183142849|SUPERIORITY||linear contrast active vs placebo|0.343||||0.986|TWO_SIDED|95.0|-41.36|42.042|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||42.042|-41.36|0.986
91625299|NCT02781454|183142850|SUPERIORITY||linear contrast active vs placebo|0.994||||0.915|TWO_SIDED|95.0|0.876|1.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.126|0.876|0.915
91625300|NCT02781454|183142851|SUPERIORITY||linear contrast active vs placebo|1.089||||0.694|TWO_SIDED|95.0|-4.609|6.786|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||6.786|-4.609|0.694
91625301|NCT02781454|183142852|SUPERIORITY||linear contrast active vs placebo|0.242||||0.969|TWO_SIDED|95.0|-12.64|13.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||13.126|-12.64|0.969
91625302|NCT02781454|183142853|SUPERIORITY||linear contrast active vs placebo|2.597||||0.323|TWO_SIDED|95.0|-2.772|7.966|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||7.966|-2.772|0.323
91625303|NCT02781454|183142854|SUPERIORITY||linear contrast active vs placebo|-2.017||||0.273|TWO_SIDED|95.0|-5.767|1.733|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.733|-5.767|0.273
91625304|NCT02781454|183142855|SUPERIORITY||linear contrast active vs placebo|0.708||||0.713|TWO_SIDED|95.0|0.111|4.535|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo||4.535|0.111|0.713
91625305|NCT02781454|183142857|SUPERIORITY||linear contrast active vs placebo|-0.399||||0.601|TWO_SIDED|95.0|-1.966|1.169|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.169|-1.966|0.601
91625306|NCT02781454|183142858|SUPERIORITY||linear contrast active vs placebo|-2.734||||0.285|TWO_SIDED|95.0|-7.938|2.471|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||2.471|-7.938|0.285
91625307|NCT00493974|183142859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Wilcoxon (Mann-Whitney)|||||||.3876
91625308|NCT00493974|183142860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6413||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6413
91625309|NCT00493974|183142861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6433
91625310|NCT00493974|183142862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Chi-squared|||||||0.63
91713912|NCT00643201|183319450|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4793|||<|0.0001|TWO_SIDED|95.0|0.3815|0.6022||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6022|0.3815|<0.0001
91625311|NCT00493974|183142863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957||95.0|||||t-test, 2 sided|||||||0.4957
91625312|NCT00493974|183142864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91625313|NCT00493974|183142865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||t-test, 2 sided|||||||0.006
91625314|NCT03796182|183142882|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|98.5|||||TWO_SIDED|90.0|82.09|118.2||||||||118.20|82.09|
91625315|NCT03796182|183142883|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|93.49|||||TWO_SIDED|90.0|85.15|102.65||||||||102.65|85.15|
91625316|NCT03796182|183142884|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|88.07|||||TWO_SIDED|90.0|80.99|95.76||||||||95.76|80.99|
91625317|NCT03796182|183142886|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|94.25|||||TWO_SIDED|90.0|88.19|100.73||||||||100.73|88.19|
91625318|NCT04682353|183142896|OTHER||Geometric Mean Ratio|0.976|||||TWO_SIDED|90.0|0.748|1.274||||||||1.274|0.748|
91625319|NCT04682353|183142896|OTHER||Geometric Mean Ratio|1.226|||||TWO_SIDED|90.0|0.94|1.598||||||||1.598|0.940|
91625320|NCT04682353|183142896|OTHER||Geometric Mean Ratio|1.817|||||TWO_SIDED|90.0|1.38|2.392||||||||2.392|1.380|
91625321|NCT04682353|183142898|OTHER||Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.96|1.506||||||||1.506|0.960|
91625322|NCT04682353|183142898|OTHER||Geometric Mean Ratio|1.393|||||TWO_SIDED|90.0|1.07|1.815||||||||1.815|1.070|
91625323|NCT04682353|183142898|OTHER||Geometric Mean Ratio|2.301|||||TWO_SIDED|90.0|1.806|2.933||||||||2.933|1.806|
91625324|NCT04682353|183142899|OTHER||Geometric Mean Ratio|1.699|||||TWO_SIDED|90.0|0.921|3.135||||||||3.135|0.921|
91625325|NCT04682353|183142899|OTHER||Geometric Mean Ratio|2.364|||||TWO_SIDED|90.0|1.273|4.39||||||||4.390|1.273|
91625326|NCT04682353|183142899|OTHER||Geometric Mean Ratio|3.748|||||TWO_SIDED|90.0|2.033|6.908||||||||6.908|2.033|
91625327|NCT04682353|183142900|OTHER||Geometric Mean Ratio|1.904|||||TWO_SIDED|90.0|0.886|4.093||||||||4.093|0.886|
91625328|NCT04682353|183142900|OTHER||Geometric Mean Ratio|3.317|||||TWO_SIDED|90.0|1.585|6.942||||||||6.942|1.585|
91625329|NCT04682353|183142900|OTHER||Geometric Mean Ratio|5.824|||||TWO_SIDED|90.0|2.796|12.135||||||||12.135|2.796|
91625330|NCT04682353|183142901|OTHER||Geometric Mean Ratio|1.095|||||TWO_SIDED|90.0|0.92|1.302||||||||1.302|0.920|
91625331|NCT04682353|183142901|OTHER||Geometric Mean Ratio|1.415|||||TWO_SIDED|90.0|1.148|1.744||||||||1.744|1.148|
91625332|NCT04682353|183142901|OTHER||Geometric Mean Ratio|2.017|||||TWO_SIDED|90.0|1.692|2.405||||||||2.405|1.692|
91625333|NCT04682353|183142902|OTHER||Geometric Mean Ratio|1.112|||||TWO_SIDED|90.0|0.948|1.303||||||||1.303|0.948|
91625334|NCT04682353|183142902|OTHER||Geometric Mean Ratio|1.439|||||TWO_SIDED|90.0|1.174|1.762||||||||1.762|1.174|
91625335|NCT04682353|183142902|OTHER||Geometric Mean Ratio|2.075|||||TWO_SIDED|90.0|1.751|2.459||||||||2.459|1.751|
91625336|NCT04682353|183142903|OTHER||Geometric Mean Ratio|1.115|||||TWO_SIDED|90.0|0.993|1.252||||||||1.252|0.993|
91625337|NCT04682353|183142903|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|90.0|1.277|1.833||||||||1.833|1.277|
91625338|NCT04682353|183142903|OTHER||Geometric Mean Ratio|2.14|||||TWO_SIDED|90.0|1.888|2.425||||||||2.425|1.888|
91625339|NCT02193828|183142940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
91625340|NCT02193828|183142940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
91625341|NCT02193828|183142940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
91625342|NCT02193828|183142940|SUPERIORITY_OR_OTHER|||||||0.0713|TWO_SIDED||||||ANOVA|||For surface area||||.0713
91625343|NCT02193828|183142940|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||For volume||||.0002
91625344|NCT02193828|183142940|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
91625345|NCT02193828|183142940|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
91625346|NCT02193828|183142940|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED||||||ANOVA|||For volume||||.0446
91625347|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.2431|TWO_SIDED||||||ANOVA|||For surface area||||.2431
91625348|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||ANOVA|||For surface area||||.0625
91625349|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANOVA|||For surface area||||.3409
91625350|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||ANOVA|||For surface area||||.7040
91625351|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.3556|TWO_SIDED||||||ANOVA|||For volume||||0.3556
91625352|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.1275|TWO_SIDED||||||ANOVA|||For volume||||.1275
91625353|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.7883|TWO_SIDED||||||ANOVA|||For volume||||.7883
91625354|NCT02193828|183142941|SUPERIORITY_OR_OTHER|||||||0.9123|TWO_SIDED||||||ANOVA|||For volume||||.9123
91625355|NCT02193828|183142942|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Kruskal-Wallis|||||||.0002
91625356|NCT02193828|183142942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
91625357|NCT02193828|183142942|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0002
91625358|NCT02193828|183142942|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0139
91625359|NCT02193828|183142943|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANOVA|||||||.0004
91625360|NCT02193828|183142943|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||ANOVA|||||||.0075
91625361|NCT02193828|183142943|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<.0001
91625362|NCT02193828|183142943|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||ANOVA|||||||.0031
91625363|NCT02193828|183142944|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED||||||ANOVA|||||||.3135
91625364|NCT02193828|183142944|SUPERIORITY_OR_OTHER|||||||0.7249|TWO_SIDED||||||ANOVA|||||||.7249
91625365|NCT02193828|183142944|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED||||||ANOVA|||||||.1573
91625366|NCT02193828|183142944|SUPERIORITY_OR_OTHER|||||||0.1234|TWO_SIDED||||||ANOVA|||||||.1234
91625367|NCT02193828|183142945|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||||||.0006
91625368|NCT02193828|183142945|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0014
91625369|NCT02193828|183142945|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0012
91625370|NCT02193828|183142945|SUPERIORITY_OR_OTHER|||||||0.1298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.1298
91625371|NCT02193828|183142946|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Kruskal-Wallis|||||||.0048
91625372|NCT02193828|183142946|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0034
91625373|NCT02193828|183142946|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0079
91625374|NCT02193828|183142946|SUPERIORITY_OR_OTHER|||||||0.3216|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3216
91625375|NCT02193828|183142947|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Fisher Exact|||||||.0065
91625376|NCT02193828|183142947|SUPERIORITY_OR_OTHER|||||||0.0349|TWO_SIDED||||||Fisher Exact|||||||.0349
91625377|NCT02193828|183142947|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Fisher Exact|||||||.0033
91625378|NCT02193828|183142947|SUPERIORITY_OR_OTHER|||||||0.3423|TWO_SIDED||||||Fisher Exact|||||||.3423
91625379|NCT00862654|183142948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||<0.01
91625380|NCT00862654|183142948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||0.039
91625381|NCT03219567|183142949|OTHER|||||||0.35|||||||t-test, 2 sided|||OCT compared to MRI||||0.35
91625382|NCT01313208|183142950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.055|TWO_SIDED|95.0|0.99|3.41|||Mantel Haenszel|P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).|Etanercept/Placebo|||3.41|0.99|0.055
91625383|NCT01412060|183143001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.001|TWO_SIDED|95.0|0.28|0.73|||Log Rank||Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||0.73|0.28|0.0010
91625384|NCT00004732|183143002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.51|||||HR (95% CI) adjusted for age, sex and symptomatic status|||1.51|0.81|
91625385|NCT00004732|183143003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.82|2.23|||||HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)|||2.23|0.82|
91625386|NCT01181778|183143015|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Daily Pill|-0.4||||0.705|TWO_SIDED|95.0|-2.6|1.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.||1.8|-2.6|0.705
91625387|NCT01181778|183143015|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Weekly Patch|3.8|||<|0.0001|TWO_SIDED|95.0|2.6|5.0|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.||5.0|2.6|<0.0001
91625388|NCT01181778|183143015|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Monthy Ring|16.0|||<|0.0001|TWO_SIDED|95.0|14.3|17.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.||17.8|14.3|<0.0001
91625389|NCT01181778|183143015|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Other Method|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.||-2.2|-5.0|<0.0001
91625390|NCT01181778|183143015|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Undecided|-15.8|||<|0.0001|TWO_SIDED|95.0|-17.6|-14.1|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.||-14.1|-17.6|<0.0001
91625391|NCT02293902|183143148|SUPERIORITY||Odds Ratio (OR)|12.185|||<|0.0001|TWO_SIDED|95.0|5.583|26.594||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 150 mg|26.594|5.583|<0.0001
91625392|NCT02293902|183143148|SUPERIORITY||Odds Ratio (OR)|7.227|||<|0.0001|TWO_SIDED|95.0|3.446|15.158||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 200 mg|15.158|3.446|<0.0001
91625393|NCT01135394|183143180|OTHER|The genes with p-values below 10\^-6 were identified|Pearson correlation p-value|0.0000001|||<|1e-07|TWO_SIDED|||||The genes with p-values below 10\^-6 were identified|Genes with p-values below 10^-6|||After the change (end-of-treatment minus baseline) in HOMA-IR index had been calculated for each subject, the change (end-of-treatment minus baseline) in expression of each of approximately 45,000 transcripts contained in a human gene array was calculated. A Pearson correlation p-value was calculated for the correlation between change in gene expression and change in HOMA-IR index, with the purpose of identifying the genes whose expression changed in concert with changes in HOMA-IR index.|The genes with P-values below 10\^-6 were identified|||<0.0000001
91625394|NCT02061748|183143193|SUPERIORITY_OR_OTHER|||||||0.0111|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0111
91625395|NCT02061748|183143194|SUPERIORITY_OR_OTHER|||||||0.0861|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0861
91625396|NCT02061748|183143195|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0011
91625397|NCT02061748|183143196|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0019
91713913|NCT00643201|183319451|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6182|||<|0.0001|TWO_SIDED|95.0|0.5432|0.7034||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.7034|0.5432|<0.0001
91791976|NCT00246571|183461739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.9624|TWO_SIDED|95.0|0.06|1.71||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Core radiology laboratory assessment||1.71|0.06|0.9624
91625398|NCT02061748|183143197|SUPERIORITY_OR_OTHER|||||||0.0808|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0808
91625399|NCT02061748|183143198|SUPERIORITY_OR_OTHER|||||||0.3502|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3502
91625400|NCT02061748|183143199|SUPERIORITY_OR_OTHER|||||||0.0068|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0068
91625401|NCT02061748|183143200|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0271
91625402|NCT02061748|183143201|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0749
91625403|NCT02061748|183143202|SUPERIORITY_OR_OTHER|||||||0.0072|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0072
91625404|NCT02061748|183143203|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0055
91625405|NCT02061748|183143204|SUPERIORITY_OR_OTHER|||||||0.0284|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0284
91625406|NCT02061748|183143205|SUPERIORITY_OR_OTHER|||||||0.907|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.907
91625407|NCT02061748|183143206|SUPERIORITY_OR_OTHER|||||||0.8208|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8208
91625408|NCT02061748|183143207|SUPERIORITY_OR_OTHER|||||||0.1534|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.1534
91625409|NCT02061748|183143208|SUPERIORITY_OR_OTHER|||||||0.3055|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3055
91625410|NCT02061748|183143209|SUPERIORITY_OR_OTHER|||||||0.9573|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.9573
91625411|NCT02061748|183143210|SUPERIORITY_OR_OTHER|||||||0.8465|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8465
91625412|NCT02061748|183143211|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0006
91625413|NCT02061748|183143212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||<0.0001
91625414|NCT02061748|183143213|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0185
91662507|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.81|||<|0.0001||95.0|-1.05|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-1.05|<0.0001
91625415|NCT02061748|183143214|SUPERIORITY_OR_OTHER|||||||0.0138|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0138
91625416|NCT02061748|183143215|SUPERIORITY_OR_OTHER|||||||0.261|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.261
91625417|NCT02061748|183143216|SUPERIORITY_OR_OTHER|||||||0.4407|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.4407
91481991|NCT01369485|182837945|SUPERIORITY_OR_OTHER|||||||0.2032|||||||Fisher Exact|||||||0.2032
91625418|NCT02061748|183143217|SUPERIORITY_OR_OTHER|||||||0.2665|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.2665
91625419|NCT02061748|183143218|SUPERIORITY_OR_OTHER|||||||0.8017|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8017
91625420|NCT02061748|183143219|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||<0.0001
91625421|NCT02061748|183143220|SUPERIORITY_OR_OTHER|||||||0.2083|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2083
91625422|NCT02061748|183143221|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0023
91625423|NCT02061748|183143222|SUPERIORITY_OR_OTHER|||||||0.5331|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.5331
91625424|NCT02061748|183143223|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0003
91625425|NCT02061748|183143224|SUPERIORITY_OR_OTHER|||||||0.2646|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2646
91625426|NCT02061748|183143225|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0004
91625427|NCT02061748|183143226|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0004
91625428|NCT02088541|183143232|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4221|TWO_SIDED|95.0|0.79|1.75|||Log Rank|||||1.75|0.79|0.4221
91625429|NCT02088541|183143233|SUPERIORITY|||||||0.9464|||||||Log Rank|||||||0.9464
91625430|NCT02088541|183143234|SUPERIORITY|||||||0.0986|||||||Cochran-Mantel-Haenszel|||||||0.0986
91625431|NCT02088541|183143236|SUPERIORITY|||||||0.0844|||||||Cochran-Mantel-Haenszel|||||||0.0844
91791977|NCT00246571|183461739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.814|TWO_SIDED|95.0|0.27|1.98||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Investigator's assessment||1.98|0.27|0.8140
91625432|NCT05742841|183143244|SUPERIORITY||Median Difference (Final Values)|-16.5|||||TWO_SIDED|||||||||||||
91625433|NCT05355818|183143286|SUPERIORITY||Diff. in proportion of responders in %|37.9|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian|Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.|There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.|Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
91625434|NCT05355818|183143287|SUPERIORITY||Diff. in proportion of responders in %|36.4|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 12.3% to 59.9%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
91625435|NCT05355818|183143288|SUPERIORITY||Diff. in proportion of responders in %|31.7|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 5.6% to 51.1%.|||||
91625436|NCT05355818|183143289|SUPERIORITY||Diff. in proportion of responders in %|31.2|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 8.7% to 49.4%|||||
91625437|NCT05355818|183143290|SUPERIORITY||Diff. in proportion of responders in %|25.1|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 3.9% to 42.3%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
91625438|NCT05355818|183143291|SUPERIORITY||Risk Difference (RD)|17.47||||0.0054|TWO_SIDED|95.0|5.16|29.78|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||29.78|5.16|0.0054
91625439|NCT05355818|183143292|SUPERIORITY||Risk Difference (RD)|21.21||||0.0248|TWO_SIDED|95.0|2.69|39.72|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||39.72|2.69|0.0248
91625440|NCT05355818|183143293|SUPERIORITY||Risk Difference (RD)|11.08||||0.332|TWO_SIDED|95.0|-11.3|33.46|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||33.46|-11.30|0.3320
91625441|NCT05355818|183143294|SUPERIORITY||Risk Difference (RD)|33.02||||0.0016|TWO_SIDED|95.0|12.51|53.52|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||53.52|12.51|0.0016
91625442|NCT05355818|183143295|SUPERIORITY||Mean Difference (Net)|-2.65||||0.0038|TWO_SIDED|95.0|-4.42|-0.88|||ANCOVA|||Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).||-0.88|-4.42|0.0038
91625443|NCT01601704|183143326|NON_INFERIORITY_OR_EQUIVALENCE|At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.|Cox Proportional Hazard|0.88|||||TWO_SIDED|99.7|0.57|1.34|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.34|0.57|
91625444|NCT01601704|183143327|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|99.7|0.66|1.33|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.33|0.66|
91625445|NCT01601704|183143328|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.5|||||TWO_SIDED|99.7|0.21|1.19|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.19|0.21|
91625446|NCT01601704|183143329|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.96|||||TWO_SIDED|99.7|0.55|1.67|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.67|0.55|
91481992|NCT01369485|182837946|SUPERIORITY_OR_OTHER|||||||0.4151||||||Calculated for only those patients who had prior OAB treatment only.|Wilcoxon (Mann-Whitney)|||||||0.4151
91625447|NCT01601704|183143330|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04|||||TWO_SIDED|99.7|0.43|2.55|||||Hazard ratio is based on CPH model with treatment as a factor.|||2.55|0.43|
91625448|NCT01783470|183143331|EQUIVALENCE|All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||||0.001|||||||Wilcoxon sign-ranks test|||Since the sample size of twelve subjects limited the ability to demonstrate that measurements were normally distributed, we used the non-parametric Wilcoxon sign-ranks test to assess the primary and secondary endpoints. All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||0.001
91625449|NCT00247273|183143333|NON_INFERIORITY_OR_EQUIVALENCE|In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.|Least Square (LS) Mean Difference|-0.115|||||TWO_SIDED|95.0|-0.505|0.274|||ANOVA|Fixed effects for treatment and pooled center||||0.274|-0.505|
91625450|NCT00247273|183143334|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.076|||||TWO_SIDED|95.0|-0.475|0.323|||ANOVA|Fixed effects for treatment and pooled center.||||0.323|-0.475|
91625451|NCT00247273|183143335|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0005|||||TWO_SIDED|95.0|-0.0035|0.0024|||ANOVA|Fixed effects for treatment and pooled center.||||0.0024|-0.0035|
91625452|NCT00247273|183143336|NON_INFERIORITY_OR_EQUIVALENCE|The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001).|LS Mean Difference|-0.239|||||TWO_SIDED|95.0|-0.727|0.249|||ANOVA|Fixed effects for treatment and pooled centers.||The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%.||0.249|-0.727|
91625453|NCT00247273|183143337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085|||||TWO_SIDED|95.0|-0.609|0.439|||ANOVA|Fixed Effects for treatment \& pooled center||||0.439|-0.609|
91625454|NCT00247273|183143338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0009|||||TWO_SIDED|95.0|-0.0048|0.0029|||ANOVA|Fixed effects for treatment and pooled center.||||0.0029|-0.0048|
91625455|NCT00247273|183143339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-2.83|3.28|||ANOVA|Fixed effects for treatment and pooled center.||||3.28|-2.83|
91625456|NCT00247273|183143340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|||||TWO_SIDED|95.0|-4.47|1.33|||ANOVA|Fixed effects for treatment and pooled center||||1.33|-4.47|
91625457|NCT00247273|183143341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.54|4.53|||ANOVA|Fixed effects for treatment and pooled center||||4.53|-2.54|
91625458|NCT00247273|183143342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-6.45|0.8|||ANOVA|Fixed effects for treatment and pooled center.||||0.80|-6.45|
91625459|NCT00247273|183143343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.05|0.0|||ANOVA|Fixed effects for treatment and pooled center||||0.00|-0.05|
91625460|NCT00247273|183143344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-7.98|-0.36|||ANOVA|Fixed effects for treatment and pooled center||||-0.36|-7.98|
91662508|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.07|||<|0.0001||95.0|-0.27|0.13|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.13|-0.27|<0.0001
91481993|NCT01369485|182837947|SUPERIORITY_OR_OTHER|||||||0.9814|||||||Fisher Exact|||"Endpoint defined as percentage of patients that much improved or very much improved following treatment."||||0.9814
91625461|NCT00247273|183143345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||ANOVA|Fixed effects for treatment and pooled center||||0.01|-0.06|
91625462|NCT00247273|183143346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|||||TWO_SIDED|95.0|-12.04|0.66|||ANOVA|Fixed effects for treatment and pooled center||||0.66|-12.04|
91625463|NCT00247273|183143347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.29|0.64|||ANOVA|Fixed effects for treatment and pooled center||||0.64|-0.29|
91625464|NCT00247273|183143348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|||||TWO_SIDED|95.0|-0.85|3.48|||ANOVA|Fixed effects for treatment and pooled center||||3.48|-0.85|
91625465|NCT00247273|183143349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.45|0.7|||ANOVA|Fixed effects for treatment and pooled center||||0.70|-0.45|
91625466|NCT00247273|183143350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-3.96|2.43|||ANOVA|Fixed effects for treatment and pooled center||||2.43|-3.96|
91625467|NCT00247273|183143351|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.36|2.54|||Fisher Exact|||||2.54|0.36|1.0000
91625468|NCT00247273|183143352|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||1|TWO_SIDED|95.0|0.47|2.03|||Fisher Exact|||||2.03|0.47|1.0000
91625469|NCT00511108|183143395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.7||||0.002||95.0|-48.7|-10.6|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-10.6|-48.7|0.002
91713914|NCT00643201|183319452|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5937|||<|0.0001|TWO_SIDED|95.0|0.5318|0.6629||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6629|0.5318|<0.0001
91481994|NCT01369485|182837947|SUPERIORITY_OR_OTHER|||||||0.7305|||||||Fisher Exact|||||||0.7305
91481995|NCT01369485|182837948|SUPERIORITY_OR_OTHER|||||||0.2191|||||||Wilcoxon (Mann-Whitney)|||||||0.2191
91481996|NCT01369485|182837948|SUPERIORITY_OR_OTHER|||||||0.5357|||||||Wilcoxon (Mann-Whitney)|||||||0.5357
91481997|NCT01306877|182837962|NON_INFERIORITY_OR_EQUIVALENCE|The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe's generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is \<7%.|Risk Difference (RD)|-0.314||||0.0001|ONE_SIDED|95.0||-0.18||P-value calculated from per protocol analysis set|Chi-squared|||||-0.18||0.0001
91481998|NCT01306877|182837966|SUPERIORITY_OR_OTHER|||||||0.1844|||||||Wilcoxon (Mann-Whitney)|||||||0.1844
91525164|NCT02019563|182925699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.49|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.49|.08|.15
91525165|NCT02019563|182925700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.38|TWO_SIDED|95.0|0.19|1.89|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.89|.19|.38
91525166|NCT02019563|182925701|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.51
91625470|NCT00511108|183143396|SUPERIORITY_OR_OTHER||Geometric Mean Difference|73.8|||<|0.001||95.0|44.2|104.4|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and log-scaled baseline value as a covariate|The outcome was analyzed by ANCOVA on the log scale. Results have been back-transformed to the original scale.|||104.4|44.2|<0.001
91625471|NCT00511108|183143397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-407.8|||<|0.001||95.0|-513.4|-302.1|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-302.1|-513.4|<0.001
91625472|NCT02911519|183143401|SUPERIORITY||Risk Ratio (RR)|0.95||||0.59|TWO_SIDED|95.0|0.77|1.16|||Mixed Models Analysis||This is intention-to-treat analysis. The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk.|||1.16|0.77|0.59
91625473|NCT02911519|183143402|SUPERIORITY||Risk Ratio (RR)|0.98||||0.73|TWO_SIDED|95.0|0.87|1.1|||Mixed Models Analysis||The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk. This is intention-to-treat analysis.|||1.10|0.87|0.73
91625474|NCT02911519|183143403|SUPERIORITY||Slope|0.01||||0.94|TWO_SIDED|95.0|-0.36|0.39|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.39|-0.36|0.94
91625475|NCT02911519|183143403|SUPERIORITY||Slope|-0.19||||0.3|TWO_SIDED|95.0|-0.57|0.18|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.18|-0.57|0.30
91625476|NCT02911519|183143405|SUPERIORITY||Slope|0.03||||0.61|TWO_SIDED|95.0|-0.1|0.17|||Mixed Models Analysis||This is an intention to treat analysis.|||0.17|-0.10|0.61
91481999|NCT01306877|182837967|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Wilcoxon (Mann-Whitney)|||||||0.5647
91525167|NCT02019563|182925702|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.64
91482000|NCT01306877|182837968|SUPERIORITY_OR_OTHER|||||||0.9062|||||||Wilcoxon (Mann-Whitney)|||||||0.9062
91482001|NCT00586196|182838010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.3|||GEE|||||2.3|0.4|
91482002|NCT00586196|182838011|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-1.5|1.2|||GEE|||||1.2|-1.5|
91482003|NCT02730208|182838037|OTHER|Treatment effect outcomes are estimates.|Least Squares (LS) Mean Difference|-1.48|||||TWO_SIDED|95.0|-7.47|4.52||||||||4.52|-7.47|
91525168|NCT02019563|182925703|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The p-value represents the survival rate from the Kaplan-Meier survival analysis from 6 to 36 months.|Log Rank|||||||.11
91527776|NCT03560258|182930595|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.100
91625477|NCT02911519|183143406|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|Slope|0.04||||0.81|TWO_SIDED|95.0|-0.38|0.3|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|||0.30|-0.38|0.81
91625478|NCT02911519|183143406|SUPERIORITY|This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|Slope|-0.04||||0.81|TWO_SIDED|95.0|-0.38|0.29|||Mixed Models Analysis||This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|||0.29|-0.38|0.81
91625479|NCT02911519|183143406|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|Slope|0.16||||0.52|TWO_SIDED|95.0|-0.33|0.65|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|||0.65|-0.33|0.52
91625480|NCT02911519|183143406|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|Slope|0.19||||0.27|TWO_SIDED|95.0|-0.15|0.53|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|||0.53|-0.15|0.27
91625481|NCT02911519|183143407|SUPERIORITY|This analysis applies to SSFB objective domain in the first row.|Slope|-0.01||||0.33|TWO_SIDED|95.0|-0.01|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB objective domain in the first row.|||0.01|-0.01|0.33
91625482|NCT02911519|183143407|SUPERIORITY|This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|Slope|-0.01||||0.19|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|||0.01|-0.02|0.19
91625483|NCT02911519|183143408|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.19|0.19|||Mixed Models Analysis||This is an intention to treat analysis.|||0.19|-0.19|0.97
91625484|NCT00810043|183143409|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.430
91482004|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91482005|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91527484|NCT02597933|182930142|OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.24||0.1711|TWO_SIDED|95.0|-0.73|4.12|||MMRM|The MMRM model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||4.12|-0.73|0.1711
91625485|NCT00810043|183143409|SUPERIORITY_OR_OTHER|||||||0.643|||||||t-test, 2 sided|||Middle vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.643
91625486|NCT00810043|183143409|SUPERIORITY_OR_OTHER|||||||0.165|||||||t-test, 2 sided|||Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.165
91625487|NCT00810043|183143410|SUPERIORITY_OR_OTHER|||||||0.402|||||||t-test, 2 sided|||Anterior VBH restored||||0.402
91625488|NCT00810043|183143410|SUPERIORITY_OR_OTHER|||||||0.578|||||||t-test, 2 sided|||Middle VBH restored||||0.578
91625489|NCT00810043|183143410|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Posterior VBH restored||||0.166
91625490|NCT00810043|183143412|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||Anterior VBH gained by postural reduction||||0.900
91625491|NCT00810043|183143412|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||Middle VBH gained by postural reduction||||0.620
91625492|NCT00810043|183143412|SUPERIORITY_OR_OTHER|||||||0.349|||||||t-test, 2 sided|||Posterior VBH gained by postural reduction||||0.349
91625493|NCT00810043|183143413|SUPERIORITY_OR_OTHER|||||||0.889|||||||t-test, 2 sided|||||||0.889
91662509|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-0.61|||<|0.0001||95.0|-0.85|-0.37|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.37|-0.85|<0.0001
91662510|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.14||||0.0052||95.0|-0.06|0.34|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.34|-0.06|0.0052
91625494|NCT00810043|183143414|SUPERIORITY_OR_OTHER|||||||0.486|||||||t-test, 2 sided|||||||0.486
91625495|NCT00810043|183143415|SUPERIORITY_OR_OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
91625496|NCT00810043|183143416|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.360
91625497|NCT02001688|183143417|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|||||||0.0005
91625498|NCT02001688|183143417|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.020
91625499|NCT02001688|183143417|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0192
91625500|NCT02001688|183143418|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|p-value of Stratified Wilcoxon test||||||0.0005
91625501|NCT02001688|183143418|SUPERIORITY|||||||0.0193|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0193
91625502|NCT02001688|183143418|SUPERIORITY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.2485
91625503|NCT02001688|183143419|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg,Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
91625504|NCT02001688|183143420|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg, Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
91625505|NCT02864706|183143442|SUPERIORITY|||||||0.0043|||||||ANCOVA|Incidence of CAV at 5-7 yrs was compared between groups using Cochran-Mantel-Haenszel test with stratification according to baseline distribution||||||0.0043
91625506|NCT02864706|183143443|SUPERIORITY|||||||0.037|||||||Cochran-Mantel-Haenszel|||||||0.037
91625507|NCT00270998|183143498|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||<0.0492
91662511|NCT00318461|183220747|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.75|||<|0.0001||95.0|-0.99|-0.51|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.51|-0.99|<0.0001
91662512|NCT00318461|183220748|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.24||||0.5282||95.0|-0.74|0.26|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.74|0.5282
91662513|NCT00318461|183220748|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.7644||95.0|-0.55|0.25|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.25|-0.55|0.7644
91662514|NCT00318461|183220748|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.36||||0.2063||95.0|-0.86|0.14|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.86|0.2063
91662515|NCT00318461|183220748|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.2678||95.0|-0.68|0.12|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.12|-0.68|0.2678
91662516|NCT00318461|183220748|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.07||||0.9887||95.0|-0.57|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.57|0.9887
91662517|NCT00318461|183220748|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.02||||0.9998||95.0|-0.38|0.42|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.42|-0.38|0.9998
91662518|NCT00318461|183220749|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.30|-2.60|<0.0001
91662519|NCT00318461|183220749|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.11||||0.967||95.0|-0.62|0.41|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.41|-0.62|0.9670
91662520|NCT00318461|183220749|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.72|||<|0.0001||95.0|-2.36|-1.07|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.07|-2.36|<0.0001
91482006|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91625508|NCT00270998|183143498|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.02||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.02
91662521|NCT00318461|183220749|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.13||||0.9368||95.0|-0.39|0.64|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.64|-0.39|0.9368
91662522|NCT00318461|183220749|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.06||||0.0003||95.0|-1.71|-0.42|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.42|-1.71|0.0003
91662523|NCT00318461|183220749|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.78||||0.0008||95.0|0.27|1.29|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.29|0.27|0.0008
91662524|NCT00318461|183220750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.66|||<|0.0001||95.0|-2.37|-0.96|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.96|-2.37|<0.0001
91662525|NCT00318461|183220750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.3||||0.5048||95.0|-0.86|0.26|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.86|0.5048
91482007|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91662526|NCT00318461|183220750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.79|||<|0.0001||95.0|-2.49|-1.08|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.08|-2.49|<0.0001
91662527|NCT00318461|183220750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.42||||0.2005||95.0|-0.98|0.14|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.98|0.2005
91791978|NCT00246571|183461742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1599||||0.8394|TWO_SIDED|95.0|0.8648|1.5558||One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Log Rank||Hazard ratio for sunitinib versus standard of care.|||1.5558|0.8648|0.8394
91482008|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91527777|NCT03560258|182930596|SUPERIORITY|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.303
91662528|NCT00318461|183220750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.16||||0.0003||95.0|-1.86|-0.46|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.46|-1.86|0.0003
91662529|NCT00318461|183220750|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.7871||95.0|-0.35|0.76|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.76|-0.35|0.7871
91662530|NCT00318461|183220751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|27.75||||0.0031||95.0|7.83|47.67|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||47.67|7.83|0.0031
91662531|NCT00318461|183220751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|1.44||||0.9987||95.0|-15.03|17.9|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||17.90|-15.03|0.9987
91662532|NCT00318461|183220751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|21.96||||0.0263||95.0|2.04|41.87|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||41.87|2.04|0.0263
91662533|NCT00318461|183220751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.36||||0.9227||95.0|-20.94|12.22|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.22|-20.94|0.9227
91662534|NCT00318461|183220751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|22.08||||0.0253||95.0|2.15|42.01|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||42.01|2.15|0.0253
91662535|NCT00318461|183220751|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.23||||0.9293||95.0|-20.78|12.31|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.31|-20.78|0.9293
91791979|NCT00775203|183461758|SUPERIORITY_OR_OTHER|||||||0.0119|||||||ANCOVA|ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.||The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.||||0.0119
91662536|NCT00318461|183220752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|25.71||||0.8821||95.0|-69.84|121.26|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||121.26|-69.84|0.8821
91662537|NCT00318461|183220752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|6.56||||0.9989||95.0|-72.66|85.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||85.79|-72.66|0.9989
91662538|NCT00318461|183220752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|35.2||||0.7292||95.0|-60.33|130.72|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||130.72|-60.33|0.7292
91482009|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91662539|NCT00318461|183220752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|16.05||||0.9689||95.0|-63.69|95.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||95.79|-63.69|0.9689
91662540|NCT00318461|183220752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|72.38||||0.1818||95.0|-23.15|167.9|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||167.90|-23.15|0.1818
91662541|NCT00318461|183220752|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|53.23||||0.2978||95.0|-26.3|132.76|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||132.76|-26.30|0.2978
91662542|NCT00796653|183220759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.167|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.167|0.091|<0.0001
91662543|NCT00796653|183220759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.116|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.116|<0.0001
91662544|NCT00796653|183220759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.112|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.188|0.112|<0.0001
91527778|NCT03560258|182930596|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.457
91662545|NCT00796653|183220760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.019||0.0055||95.0|0.015|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.090|0.015|0.0055
91662546|NCT00796653|183220760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|0.032|0.0003
91791980|NCT05171816|183461782|OTHER|Exploratory|Hazard Ratio (HR)|1.43||||0.2592|TWO_SIDED|95.0|0.83|2.48||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.48|0.83|0.2592
91791981|NCT05171816|183461783|OTHER|Exploratory|Hazard Ratio (HR)|1.14||||0.7251|TWO_SIDED|95.0|0.57|2.29||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.29|0.57|0.7251
91662547|NCT00796653|183220760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.027||95.0|0.005|0.08|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.080|0.005|0.0270
91662548|NCT00796653|183220761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.314||0.1999||95.0|-0.213|1.018|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.018|-0.213|0.1999
91662549|NCT00796653|183220761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.314||0.1818||95.0|-0.196|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.035|-0.196|0.1818
91482010|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91625509|NCT00270998|183143498|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.49||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.49
91662550|NCT00796653|183220761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.602|STANDARD_ERROR_OF_MEAN|0.316||0.0572||95.0|-0.019|1.222|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.222|-0.019|0.0572
91662551|NCT00796653|183220762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.349||0.0197||95.0|-5.796|-0.503|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.503|-5.796|0.0197
91662552|NCT00796653|183220762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.524|STANDARD_ERROR_OF_MEAN|1.354||0.0094||95.0|-6.18|-0.867|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.867|-6.180|0.0094
91662553|NCT00796653|183220762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.416|STANDARD_ERROR_OF_MEAN|1.365||0.2995||95.0|-4.093|1.261|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.261|-4.093|0.2995
91662554|NCT00796653|183220763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|STANDARD_ERROR_OF_MEAN|1.385||0.7995||95.0|-3.068|2.365|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||2.365|-3.068|0.7995
91527779|NCT03560258|182930596|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.678
91625510|NCT00270998|183143499|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.006|||||||Regression, Logistic|||||||0.006
91625511|NCT00270998|183143499|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
91625512|NCT00270998|183143499|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.42|||||||Regression, Logistic|||||||0.42
91625513|NCT00270998|183143500|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625514|NCT00270998|183143500|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625515|NCT00270998|183143500|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625516|NCT00270998|183143501|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625517|NCT00270998|183143501|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91662555|NCT00796653|183220763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.391||0.4336||95.0|-3.818|1.639|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.639|-3.818|0.4336
91662556|NCT00796653|183220763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|1.395||0.9365||95.0|-2.625|2.848|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.848|-2.625|0.9365
91662557|NCT00796653|183220764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.625|STANDARD_ERROR_OF_MEAN|1.333||0.0491||95.0|-5.241|-0.01|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.010|-5.241|0.0491
91662558|NCT00796653|183220764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.489|STANDARD_ERROR_OF_MEAN|1.341||0.0636||95.0|-5.119|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|-5.119|0.0636
91662559|NCT00796653|183220764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.158|STANDARD_ERROR_OF_MEAN|1.35||0.0194||95.0|-5.806|-0.511|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||-0.511|-5.806|0.0194
91662560|NCT00796653|183220765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034|TWO_SIDED|95.0|-4.751|-0.94|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 5 mcg minus placebo||-0.940|-4.751|0.0034
91662561|NCT00796653|183220765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004|TWO_SIDED|95.0|-5.343|-1.525|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 10 mcg minus placebo||-1.525|-5.343|0.0004
91662562|NCT00796653|183220765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009|TWO_SIDED|95.0|-3.161|0.665|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Form 12 mcg minus placebo||0.665|-3.161|0.2009
91482011|NCT00245219|182838061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91482012|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91662563|NCT00796653|183220766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.123|<0.0001
91662564|NCT00796653|183220766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.193|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.157|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.157|<0.0001
91527780|NCT03560258|182930597|SUPERIORITY|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD8 T cell responses from week 0 to week 26.||||0.755
91662565|NCT00796653|183220766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.199|0.126|<0.0001
91662566|NCT00796653|183220767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
91662567|NCT00796653|183220767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.228|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.228|0.155|<0.0001
91527781|NCT03560258|182930597|SUPERIORITY|||||||0.867|||||||Wilcoxon (Mann-Whitney)|||||||0.867
91527782|NCT03560258|182930597|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
91662568|NCT00796653|183220767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.148|0.221|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.221|0.148|<0.0001
91662569|NCT00796653|183220768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.108|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.182|0.108|<0.0001
91662570|NCT00796653|183220768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.138|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.138|<0.0001
91662571|NCT00796653|183220768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.208|0.133|<0.0001
91662572|NCT00796653|183220769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.080|<0.0001
91662573|NCT00796653|183220769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.180|0.103|<0.0001
91527783|NCT01460160|182930598|SUPERIORITY||Estimate of Difference|16.86||||0.032|TWO_SIDED|90.0|3.9|29.8||Superiority test versus AIEOP-BFM 2000|Chi-squared||Treatment difference (CA180372 - AIEOP-BFM 2000)|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control||29.8|3.9|0.032
91662574|NCT00796653|183220769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.091|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.168|0.091|<0.0001
91713915|NCT02346708|183319460|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.1|TWO_SIDED|95.0|-4.56|0.42||We determined whether there was a significant group difference between the real and sham treated PD-MCI patients on the DRS-2 change following rTMS using mixed model regression (MMR) to fit longitudinal models.|Mixed Models Analysis|degrees of freedom: 46||We estimated a sample size of 20 per group would provide at least 80% power at a significance level of 0.05 to detect a between-group difference of 10 on the Matthis Dementia Rating Scale-2, an effect size similar to prior studies of rivastigmine.||0.42|-4.56|0.1
91625518|NCT00270998|183143501|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625519|NCT00270998|183143502|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625520|NCT00270998|183143502|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625521|NCT00270998|183143502|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625522|NCT00270998|183143503|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625523|NCT00270998|183143503|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91662575|NCT00796653|183220770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.018||0.0002||95.0|0.033|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.033|0.0002
91662576|NCT00796653|183220770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.083|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.155|0.083|<0.0001
91662577|NCT00796653|183220770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.018||0.0071||95.0|0.013|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.013|0.0071
91662578|NCT00796653|183220771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.048|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|0.048|<0.0001
91625524|NCT00270998|183143503|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625525|NCT00270998|183143504|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.03|||||||Regression, Logistic|||||||0.03
91625526|NCT00270998|183143504|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
91625527|NCT00270998|183143504|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625528|NCT00270998|183143505|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625529|NCT00270998|183143505|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625530|NCT00270998|183143505|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
91625531|NCT00047853|183143515|OTHER||||||<|0.001|||||||ANOVA|||||||< 0.001
91625532|NCT00047853|183143516|OTHER|||||||9.3e-05|||||||t-test, 2 sided|||||||0.000093
91625533|NCT02443805|183143518|SUPERIORITY||||||<|0.0001||||||Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.|ANCOVA|||||||<0.0001
91482013|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91525169|NCT00840996|182925714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|97.5|-1.23|-0.4||Test for superiority adjusted for 2 primary comparisons (2 outcomes)|Mixed Models Analysis|Llinear mixed-effects accounts for correlation exhibited by the repeated pain measurements on a given patient (spatial power correlation structure).||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||-0.40|-1.23|<0.001
91527784|NCT01460160|182930598|NON_INFERIORITY|non-inferiority margin = 5%. One-sided type I error rate of 0.05|Estimate of difference|6.91||||0.271|TWO_SIDED|90.0|-3.3|17.2||Superiority test versus EsPhALL|Chi-squared||Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%|Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control||17.2|-3.3|0.271
91662579|NCT00796653|183220771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.068|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|0.068|<0.0001
91625534|NCT00968708|183143524|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.962||||0.315|ONE_SIDED|97.5||1.16|||Cox proportional hazards|||Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.||1.160||0.315
91625535|NCT00968708|183143524|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.965||||0.332|ONE_SIDED|97.5||1.169||Stratified by endpoint renal function (defined as the last observed postbaseline renal function (normal renal function/mild renal impairment vs moderate/severe renal impairment including end-stage renal disease)) and geographic region.|Cox proportional hazards|||Stratified by endpoint renal function and geographic region||1.169||0.332
91625536|NCT00968708|183143525|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the confidence interval for the primary MACE composite was \<1.0, then statistical superiority of alogliptin to placebo for the secondary MACE composite would be demonstrated.|Hazard Ratio (HR)|0.952|||||ONE_SIDED|97.5||1.135||||||||1.135||
91625537|NCT00587834|183143562|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact Bionomial Test|||Superiority relative to a pre-defined standard (50% success)||||<0.0001
91625538|NCT00587834|183143563|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red||||<0.0001
91625539|NCT00587834|183143564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm||||<0.0001
91625540|NCT00587834|183143565|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||Superiority relative to a pre-defined threshold (80%) success||||<0.0001
91625541|NCT00587834|183143566|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||The proportion of Gintuit as the preferred procedure.||||<0.0001
91625542|NCT00587834|183143567|SUPERIORITY_OR_OTHER|||||||0.3173||95.0|||||McNemar|McNemar's paired comparison test||Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.||||0.3173
91625543|NCT00305604|183143590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.81|<|0.001||95.0|-0.94|-0.47|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-0.47|-0.94|<0.001
91625544|NCT00305604|183143591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|STANDARD_DEVIATION|45.0|<|0.001||95.0|-40.0|-13.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-13.5|-40.0|<0.001
91625545|NCT00305604|183143592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.0|STANDARD_DEVIATION|63.0|<|0.001||95.0|-82.1|-40.0|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-40.0|-82.1|<0.001
91625546|NCT00305604|183143593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.5|STANDARD_DEVIATION|25.2|<|0.001||95.0|-32.6|-14.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-14.4|-32.6|<0.001
91625547|NCT03488914|183143597|SUPERIORITY||Slope|-1.09||||0.19|TWO_SIDED|95.0|-2.78|0.56|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 3-months||||.56|-2.78|.19
91625548|NCT03488914|183143597|SUPERIORITY||negative binomial regression|-1.66||||0.12|TWO_SIDED|95.0|-3.78|0.48|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 6-months||||.48|-3.78|.12
91625549|NCT03488914|183143597|SUPERIORITY||Slope|0.01||||0.99|TWO_SIDED|95.0|-2.05|2.07|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 9-months||||2.07|-2.05|.99
91625550|NCT03488914|183143597|SUPERIORITY||Slope|-0.78||||0.42|TWO_SIDED|95.0|-2.67|1.11|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 12-months||||1.11|-2.67|.42
91625551|NCT03488914|183143597|SUPERIORITY||Slope|-1.09||||0.18|TWO_SIDED|95.0|-2.69|0.51|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 15-months||||.51|-2.69|.18
91625552|NCT03488914|183143598|SUPERIORITY||Slope|0.03||||0.96|TWO_SIDED|95.0|-0.86|0.99|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 3-months||||.99|-.86|.96
91625553|NCT03488914|183143598|SUPERIORITY||Slope|-1.19||||0.03|TWO_SIDED|95.0|-2.25|-0.14|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 6-months||||-.14|-2.25|.03
91625554|NCT03488914|183143598|SUPERIORITY||Slope|0.13||||0.79|TWO_SIDED|95.0|-0.83|1.1|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 9-months||||1.10|-.83|.79
91625555|NCT03488914|183143598|SUPERIORITY||Slope|0.06||||0.91|TWO_SIDED|95.0|-0.99|1.11|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 12-months||||1.11|-.99|.91
91625556|NCT03488914|183143598|SUPERIORITY||Slope|-0.42||||0.44|TWO_SIDED|95.0|-1.5|0.65|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 15-months||||.65|-1.50|.44
91625557|NCT03488914|183143599|SUPERIORITY||Slope|-0.26||||0.54|TWO_SIDED|95.0|-1.09|0.58|||negative binomial regression|Model testing whether condition predicted marijuana use days at 3-months||||.58|-1.09|.54
91625558|NCT03488914|183143599|SUPERIORITY||Slope|0.38||||0.49|TWO_SIDED|95.0|-0.7|1.46|||negative binomial regression|Model testing whether condition predicted marijuana use days at 6-months||||1.46|-.70|.49
91625559|NCT03488914|183143599|SUPERIORITY||Slope|-0.26||||0.59|TWO_SIDED|95.0|-1.18|0.66|||negative binomial regression|Model testing whether condition predicted marijuana use days at 9-months||||.66|-1.18|.59
91625560|NCT03488914|183143599|SUPERIORITY||Slope|0.26||||0.65|TWO_SIDED|95.0|-0.86|1.37|||negative binomial regression|Model testing whether condition predicted marijuana use days at 12-months||||1.37|-.86|.65
91625561|NCT03488914|183143599|SUPERIORITY||Slope|-0.36||||0.49|TWO_SIDED|95.0|-1.4|0.67|||negative binomial regression|Model testing whether condition predicted marijuana use days at 15-months||||.67|-1.40|.49
91625562|NCT03488914|183143600|SUPERIORITY||Slope|-0.36||||0.31|TWO_SIDED|995.0|-1.07|0.34|||negative binomial regression|Model testing whether condition predicted alcohol use days at 3-months||||.34|-1.07|.31
91662580|NCT00796653|183220771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018||0.0001||95.0|0.034|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.106|0.034|0.0001
91625563|NCT03488914|183143600|SUPERIORITY||Slope|-0.71||||0.1|TWO_SIDED|95.0|-1.57|0.15|||negative binomial regression|Model testing whether condition predicted alcohol use days at 6-months||||.15|-1.57|.10
91625564|NCT03488914|183143600|SUPERIORITY||Slope|-0.53||||0.2|TWO_SIDED|95.0|-1.34|0.28|||negative binomial regression|Model testing whether condition predicted alcohol use days at 9-months||||.28|-1.34|.20
91625565|NCT03488914|183143600|SUPERIORITY||Slope|-0.25||||0.58|TWO_SIDED|95.0|-1.14|0.64|||negative binomial regression|Model testing whether condition predicted alcohol use days at 12-months||||.64|-1.14|.58
91625566|NCT03488914|183143600|SUPERIORITY||Slope|-0.45||||0.34|TWO_SIDED|95.0|-1.37|0.47|||negative binomial regression|Model testing whether condition predicted alcohol use days at 15-months||||.47|-1.37|.34
91625567|NCT01021813|183143621|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-1.1|1.4|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any sleep paralysis AEs between the Suvorexant group and Placebo group .||1.4|-1.1|
91625568|NCT01021813|183143622|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.482|TWO_SIDED|95.0|-1.3|1.1|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any complex sleep-related behaviors AEs between the Suvorexant group and Placebo group.||1.1|-1.3|0.482
91625569|NCT01021813|183143623|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.508|TWO_SIDED|95.0|-3.9|1.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any falls AEs between the Suvorexant group and Placebo group.||1.5|-3.9|0.508
91625570|NCT01021813|183143624|SUPERIORITY_OR_OTHER||Difference in Percentage of AEs|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any suicidal ideation/behavior AEs considered an ECI between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
91625571|NCT01021813|183143625|SUPERIORITY_OR_OTHER||Difference in Percentage|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any Hypnagogic/hypnopompic hallucinations AEs between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
91625572|NCT01021813|183143626|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4||||0.767|TWO_SIDED|95.0|-3.8|2.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any selected AEs associated with potential abuse between the Suvorexant group and Placebo group.||2.2|-3.8|0.767
91625573|NCT01021813|183143627|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|-0.81||||0.567|TWO_SIDED|95.0|-5.1|3.1|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.1|-5.1|0.567
91527785|NCT01460160|182930598|SUPERIORITY|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control|Estimate of difference|-10.75||||0.157|TWO_SIDED|90.0|-22.7|1.2|||Chi-squared||Treatment difference (CA180372 - COG AALL0031)|||1.2|-22.7|0.157
91625574|NCT01021813|183143627|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|-2.4||||0.185|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||1.6|-7.3|0.185
91625575|NCT01021813|183143627|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|-0.78||||0.68|TWO_SIDED|95.0|-5.6|3.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.9|-5.6|0.680
91625576|NCT01021813|183143627|SUPERIORITY_OR_OTHER||Difference in Percentage: Across Nights|0.0||||1|TWO_SIDED|95.0|-6.4|6.4|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms across Nights 1, 2, and 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||6.4|-6.4|1.000
91625577|NCT01021813|183143628|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|5.03||||0.365|TWO_SIDED|95.0|-5.8|15.8|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.8|-5.8|0.365
91625578|NCT01021813|183143628|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|8.72||||0.109|TWO_SIDED|95.0|-2.0|19.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||19.2|-2.0|0.109
91625579|NCT01021813|183143628|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|6.02||||0.287|TWO_SIDED|95.0|-5.1|16.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||16.9|-5.1|0.287
91625580|NCT01021813|183143628|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|10.82||||0.057|TWO_SIDED|95.0|-0.3|21.7|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||21.7|-0.3|0.057
91625581|NCT01021813|183143629|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|4.46||||0.386|TWO_SIDED|95.0|-5.7|14.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||14.5|-5.7|0.386
91625582|NCT01021813|183143629|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|5.31||||0.311|TWO_SIDED|95.0|-5.0|15.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.5|-5.0|0.311
91625583|NCT01021813|183143629|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|4.96||||0.351|TWO_SIDED|95.0|-5.5|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-5.5|0.351
91625584|NCT01021813|183143629|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|4.58||||0.409|TWO_SIDED|95.0|-6.3|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-6.3|0.409
91625585|NCT01021813|183143630|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|22.7|||<|0.0001|TWO_SIDED|95.0|16.4|29.0||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSTm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||29.0|16.4|<0.0001
91625586|NCT01021813|183143631|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|-9.5||||0.0002|TWO_SIDED|95.0|-14.6|-4.5||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSOm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||-4.5|-14.6|0.0002
91625587|NCT01269047|183143651|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|2.4||0.04|TWO_SIDED|95.0|-4.2|-0.2|||ANOVA|||||-0.2|-4.2|0.04
91625588|NCT01269047|183143651|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|2.7||0.008|TWO_SIDED|95.0|-5.8|-1.3|||ANOVA|||||-1.3|-5.8|0.008
91625589|NCT01269047|183143651|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_DEVIATION|2.6||0.003|TWO_SIDED|95.0|-6.4|-2.0|||ANOVA|||||-2.0|-6.4|0.003
91625590|NCT01269047|183143651|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|2.0||0.37|TWO_SIDED|95.0|-2.3|0.98|||ANOVA|||||0.98|-2.3|0.37
91625591|NCT01269047|183143652|OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.8||0.2|TWO_SIDED|95.0|-0.21|0.81|||t-test, 2 sided|||||0.81|-0.21|0.2
91625592|NCT01269047|183143652|OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.6||0.48|TWO_SIDED|95.0|-0.25|0.5|||t-test, 2 sided|||||0.50|-0.25|0.48
91625593|NCT01269047|183143652|OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.6||0.18|TWO_SIDED|95.0|-0.12|0.57|||t-test, 2 sided|||||0.57|-0.12|0.18
91625594|NCT01269047|183143652|OTHER||Mean Difference (Final Values)|-0.004|STANDARD_DEVIATION|1.0||1|TWO_SIDED|95.0|-0.62|0.61|||t-test, 2 sided|||||0.61|-0.62|1.0
91625595|NCT01569087|183143653|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
91625596|NCT01626989|183143659|NON_INFERIORITY_OR_EQUIVALENCE|Friedman Test comparing all 3 nights||||||0.001|||||||nonparametric Wilcoxon Signed Rank test|||||||.001
91625597|NCT03366844|183143673|OTHER||Proportion|0.6|||||TWO_SIDED|95.0|0.465|0.724|||||95% confidence interval for one proportion were estimated using the Exact (Clopper-Pearson) method.|||0.724|0.465|
91625598|NCT00595868|183143702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.06|TWO_SIDED|95.0|1.0|2.9|||Chi-squared|||||2.9|1.0|0.06
91625599|NCT00595868|183143703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.1|TWO_SIDED|95.0|0.9|5.2|||Chi-squared|||||5.2|0.9|0.10
91625600|NCT02688153|183143704|SUPERIORITY||Median Difference (Final Values)|-4.5||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3660
91625601|NCT02688153|183143705|SUPERIORITY||Median Difference (Final Values)|2.0||||0.8377|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8377
91625602|NCT02971007|183143772|OTHER|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.||||||||||||||||No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.|||
91625603|NCT00607919|183143810|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91625604|NCT00443846|183143863|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 95% confidence interval of the difference (Group 1 - Group 2) in seroprotection rate was greater than -10%.|Difference (Group 1 - Group 2)|0.0|||||TWO_SIDED|95.0|-3.7|3.7||||||Analysis of non-inferiority was based on the Miettinen and Nurminen method||3.7|-3.7|
91625605|NCT00109772|183143877|SUPERIORITY_OR_OTHER|||||||0.894||95.0|||||Cochran-Mantel-Haenszel|controlled for centers||||||.8940
91625606|NCT03437044|183143894|SUPERIORITY|||||||0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||0.001
91625607|NCT03437044|183143895|SUPERIORITY||||||<|0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||<0.001
91791982|NCT05171816|183461784|OTHER|Exploratory|Hazard Ratio (HR)|0.99||||0.9715|TWO_SIDED|95.0|0.6|1.64||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.64|0.60|0.9715
91625608|NCT05441540|183143900|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91625609|NCT05441540|183143901|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91625610|NCT05441540|183143902|OTHER|||||||0.7613|||||||Kruskal-Wallis|||||||0.7613
91625611|NCT05441540|183143903|OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.7640
91625612|NCT00813917|183143904|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.|Chi-squared|1 sided||Data were compared between treatment groups using Chi Square test.||||0.126
91625613|NCT01359046|183143905|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
91625614|NCT01359046|183143906|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91625615|NCT02665468|183143907|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91625616|NCT03037307|183143928|OTHER||Least square (LS) mean difference|2.76|||<|0.0001|TWO_SIDED|95.0|1.89|3.63||Treatment Comparison for study validity.|ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.63|1.89|<.0001
91625617|NCT03037307|183143929|OTHER||Least Square (LS) mean difference|2.12|||<|0.0001|TWO_SIDED|95.0|1.25|3.0|||ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.00|1.25|<.0001
91625618|NCT01484561|183143998|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.92|||||TWO_SIDED|90.0|0.86|0.98|||ANCOVA||Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.86|
91625619|NCT01484561|183143999|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|0.97|1.11|||ANCOVA||ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.11|0.97|
91525170|NCT00840996|182925715|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group|the ratio of the geometric means|0.8||||0.011|TWO_SIDED|95.0|0.65|1.21||Noninferiority hypotheses were evaluated against a one-sided significance criterion of 0.025 \[adjusting for testing in both directions: lidocaine vs. control and vs. control vs. lidocaine \]|Regression, Linear|Log-linear regression model was used; 0.1 mg added before taking the logarithm to accommodate the 2 patients who received 0 mg opioids.||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||1.21|0.65|0.011
91625620|NCT01484561|183144000|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.09|||||TWO_SIDED|90.0|1.02|1.16|||ANCOVA||ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.16|1.02|
91625621|NCT01484561|183144001|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.94|||||TWO_SIDED|90.0|0.91|0.97|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.97|0.91|
91625622|NCT01484561|183144002|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.96|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.96|
91625623|NCT01484561|183144003|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.0|1.08|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.00|
91625624|NCT01484561|183144004|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.95|||||TWO_SIDED|90.0|0.92|0.98|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.92|
91625625|NCT01484561|183144005|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.97|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.97|
91625626|NCT01484561|183144006|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.01|1.07|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.07|1.01|
91625627|NCT01484561|183144007|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.05|||||TWO_SIDED|90.0|1.02|1.08|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.02|
91625628|NCT01484561|183144008|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.01|||||TWO_SIDED|90.0|0.98|1.04|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.04|0.98|
91625629|NCT01484561|183144009|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.97|||||TWO_SIDED|90.0|0.94|1.0|||ANCOVA||ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.00|0.94|
91625630|NCT01484561|183144010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.16|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|90.0|23.6|48.73||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 1||48.73|23.60|<0.001
91625631|NCT01484561|183144010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.95|STANDARD_ERROR_OF_MEAN|8.14||0.05|TWO_SIDED|90.0|2.56|29.34||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 2||29.34|2.56|0.050
91625632|NCT01484561|183144011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|5.94|<|0.001|TWO_SIDED|90.0|11.24|30.8||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 1||30.80|11.24|<0.001
91625633|NCT01484561|183144011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_ERROR_OF_MEAN|6.13||0.006|TWO_SIDED|90.0|6.92|27.08||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 2||27.08|6.92|0.006
91625634|NCT01484561|183144012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|90.0|12.06|25.05||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 1||25.05|12.06|<0.001
91625635|NCT01484561|183144012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.32|STANDARD_ERROR_OF_MEAN|3.53||0.038|TWO_SIDED|90.0|1.51|13.12||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 2||13.12|1.51|0.038
91625636|NCT01484561|183144013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.53|-0.78||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.78|-1.53|<0.001
91625637|NCT01484561|183144014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.21||0.028|TWO_SIDED|90.0|-0.83|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.83|0.028
91625638|NCT01484561|183144015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|90.0|0.32|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|0.32|0.002
91625639|NCT01484561|183144016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|-1.67|-0.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.84|-1.67|<0.001
91625640|NCT01484561|183144017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.031|TWO_SIDED|90.0|-0.88|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.88|0.031
91625641|NCT01484561|183144018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|90.0|0.36|1.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.15|0.36|0.002
91625642|NCT01484561|183144019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.09|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|90.0|-7.44|-0.74||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.74|-7.44|0.045
91625643|NCT01484561|183144020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.76||0.936|TWO_SIDED|90.0|-2.78|3.06||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.06|-2.78|0.936
91625644|NCT01484561|183144021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.93||0.03|TWO_SIDED|90.0|1.04|7.42||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||7.42|1.04|0.030
91625645|NCT01484561|183144022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|1.03||0.03|TWO_SIDED|90.0|-3.96|-0.55||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.55|-3.96|0.030
91625646|NCT01484561|183144023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.472|TWO_SIDED|90.0|-2.64|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|-2.64|0.472
91625647|NCT01484561|183144024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.03||0.158|TWO_SIDED|90.0|-0.24|3.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.15|-0.24|0.158
91625648|NCT01484561|183144025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.73|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|90.0|-19.87|-7.59||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.59|-19.87|<0.001
91625649|NCT01484561|183144026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|STANDARD_ERROR_OF_MEAN|4.04||0.029|TWO_SIDED|90.0|-15.58|-2.21||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-2.21|-15.58|0.029
91625650|NCT01484561|183144027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.84|STANDARD_ERROR_OF_MEAN|2.98||0.107|TWO_SIDED|90.0|-0.1|9.77||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||9.77|-0.10|0.107
91625651|NCT01484561|183144028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|4.87||0.001|TWO_SIDED|90.0|-23.96|-7.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.84|-23.96|0.001
91662581|NCT00796653|183220772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0017||95.0|0.022|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.022|0.0017
91662582|NCT00796653|183220772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.057|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.130|0.057|<0.0001
91713916|NCT02976519|183319462|OTHER||Slope|1.2705|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|1.1067|1.4343|||||Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4343|1.1067|
91713917|NCT02976519|183319462|OTHER||Slope|1.1361|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.9598|1.3123|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.3123|0.9598|
91482014|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91662583|NCT00796653|183220772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.101|0.028|0.0005
91482015|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91625652|NCT01484561|183144029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|4.95||0.251|TWO_SIDED|90.0|-13.9|2.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.50|-13.90|0.251
91625653|NCT01484561|183144030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.19|STANDARD_ERROR_OF_MEAN|4.42||0.023|TWO_SIDED|90.0|2.87|17.52||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.52|2.87|0.023
91625654|NCT01484561|183144031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.12|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|90.0|-21.58|-8.67||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-8.67|-21.58|<0.001
91625655|NCT01484561|183144032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.77||0.616|TWO_SIDED|90.0|-10.3|5.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||5.50|-10.30|0.616
91662584|NCT00796653|183220773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.0085||95.0|0.013|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.013|0.0085
91662585|NCT00796653|183220773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.049|<0.0001
91662586|NCT00796653|183220773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019||0.0067||95.0|0.014|0.088|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.088|0.014|0.0067
91713918|NCT02976519|183319463|OTHER||Slope|1.2743|STANDARD_ERROR_OF_MEAN|0.0739|||TWO_SIDED|95.0|1.1231|1.4255|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4255|1.1231|
91713919|NCT02976519|183319463|OTHER||Slope|1.0924|STANDARD_ERROR_OF_MEAN|0.0793|||TWO_SIDED|95.0|0.9296|1.2551|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.2551|0.9296|
91713920|NCT03416270|183319464|OTHER|||||||0.36||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.36
91713921|NCT03416270|183319464|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
91662587|NCT00796653|183220774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.100|0.025|0.0012
91662588|NCT00796653|183220774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.035|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.110|0.035|0.0002
91662589|NCT00796653|183220774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0117||95.0|0.011|0.086|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.086|0.011|0.0117
91662590|NCT00796653|183220775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0014||95.0|0.024|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.024|0.0014
91662591|NCT00796653|183220775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.047|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.047|<0.0001
91662592|NCT00796653|183220775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.019||0.0035||95.0|0.019|0.094|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.094|0.019|0.0035
91662593|NCT00796653|183220776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0228||95.0|0.006|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.082|0.006|0.0228
91662594|NCT00796653|183220776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.021|0.097|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.097|0.021|0.0024
91525171|NCT00840996|182925716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.049|TWO_SIDED|95.0|0.84|1.0|||Regression, Logistic|||||1.00|0.84|0.049
91662595|NCT00796653|183220776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.019||0.0664||95.0|-0.002|0.074|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.074|-0.002|0.0664
91662596|NCT00796653|183220777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.122|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.199|0.122|<0.0001
91662597|NCT00796653|183220777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.14|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.216|0.140|<0.0001
91662598|NCT00796653|183220777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.115|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.191|0.115|<0.0001
91662599|NCT00796653|183220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.13|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.130|<0.0001
91662600|NCT00796653|183220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.143|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.220|0.143|<0.0001
91662601|NCT00796653|183220778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.137|<0.0001
91525172|NCT00840996|182925717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.31|TWO_SIDED|95.0|0.77|1.09|||Regression, Logistic|||Nausea - POD 2||1.09|0.77|0.31
91662602|NCT00796653|183220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.103|<0.0001
91662603|NCT00796653|183220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.129|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.129|<0.0001
91662604|NCT00796653|183220779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.125|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.203|0.125|<0.0001
91713922|NCT03416270|183319465|OTHER|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||||||0.303
91525173|NCT00840996|182925717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.14|||Regression, Logistic|||Vomiting - POD 2||1.14|0.94|0.44
91525174|NCT00840996|182925718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.15|TWO_SIDED|95.0|-2.4|0.4|||Regression, Linear|||||0.4|-2.4|0.15
91482016|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91625656|NCT01484561|183144033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.72|STANDARD_ERROR_OF_MEAN|4.17||0.003|TWO_SIDED|90.0|5.82|19.62||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||19.62|5.82|0.003
91662605|NCT00796653|183220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.084|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.163|0.084|<0.0001
91625657|NCT01484561|183144034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|90.0|-22.78|-7.82||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.82|-22.78|<0.001
91625658|NCT01484561|183144035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|4.83||0.247|TWO_SIDED|90.0|-13.62|2.38||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.38|-13.62|0.247
91625659|NCT01484561|183144036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.68|STANDARD_ERROR_OF_MEAN|4.67||0.04|TWO_SIDED|90.0|1.95|17.41||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.41|1.95|0.040
91625660|NCT01484561|183144037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|90.0|-0.56|-0.23||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.23|-0.56|<0.001
91625661|NCT01484561|183144038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.053|TWO_SIDED|90.0|-0.31|-0.03||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.03|-0.31|0.053
91625662|NCT01484561|183144039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|90.0|0.1|0.35||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||0.35|0.10|0.003
91625663|NCT03371251|183144041|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: SRI-4 Response||18.5|-14.5|0.8434
91625664|NCT03371251|183144041|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: \>= 4-Point Reduction from Baseline in SLEDAI-2K Global Score||18.5|-14.5|0.8434
91625665|NCT03371251|183144041|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No New BILAG A or More than One BILAG B Organ Score Compared with Baseline||30.9|4.5|0.0141
91625666|NCT03371251|183144041|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No Deterioration from Baseline in PGA by \>=30mm||30.9|4.5|0.0141
91625667|NCT03371251|183144057|SUPERIORITY||Observed Difference vs. Placebo|-2.6||||0.7985|TWO_SIDED|90.0|-19.8|14.5|||Pearson's chi-square test|||||14.5|-19.8|0.7985
91625668|NCT03371251|183144058|SUPERIORITY||Observed Difference vs. Placebo|-6.9||||0.3498|TWO_SIDED|90.0|-22.9|9.8|||Pearson's chi-square test|||Statistical Analysis for Overall||9.8|-22.9|0.3498
91625669|NCT03371251|183144059|SUPERIORITY||Observed Difference vs. Placebo|-21.8||||0.0072|TWO_SIDED|90.0|-36.2|-7.4|||Pearson's chi-square test|||Statistical analysis for Overall||-7.4|-36.2|0.0072
91482017|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91625670|NCT03371251|183144059|SUPERIORITY||Observed Difference vs. Placebo|-17.7||||0.0141|TWO_SIDED|90.0|-30.9|-4.5|||Pearson's chi-square test|||Statistical Analysis for Day 210||-4.5|-30.9|0.0141
91625671|NCT03371251|183144060|SUPERIORITY||Observed Difference vs. Placebo|4.9||||0.6107|TWO_SIDED|90.0|-10.7|20.5|||Pearson's chi-square test|||||20.5|-10.7|0.6107
91625672|NCT03371251|183144061|SUPERIORITY||Observed Difference vs. Placebo|15.4||||0.1237|TWO_SIDED|90.0|-0.9|31.8|||Pearson's chi-square test|||||31.8|-0.9|0.1237
91713923|NCT03416270|183319466|OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
91713924|NCT03416270|183319467|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.599
91525175|NCT00840996|182925719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.002|TWO_SIDED|95.0|2.3|10.0|||Regression, Linear|||||10|2.3|0.002
91525176|NCT00840996|182925720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.04|TWO_SIDED|95.0|0.3|8.9|||Regression, Logistic|||||8.9|0.3|0.04
91625673|NCT03371251|183144062|SUPERIORITY||Observed Difference vs. Placebo|-13.7||||0.0581|TWO_SIDED|90.0|-26.7|-0.7|||Pearson's chi-square test|||Statistical Analysis for Overall||-0.7|-26.7|0.0581
91625674|NCT03371251|183144062|SUPERIORITY||Observed Difference vs. Placebo|-14.3||||0.0471|TWO_SIDED|90.0|-31.2|3.2|||Pearson's chi-square test|||Statistical Analysis for Day 210||3.2|-31.2|0.0471
91625675|NCT03371251|183144063|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|-0.3|STANDARD_ERROR_OF_MEAN|0.78||0.6596|TWO_SIDED|90.0|-1.63|0.94|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-A (Total Activity)||0.94|-1.63|0.6596
91625676|NCT03371251|183144063|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.3|STANDARD_ERROR_OF_MEAN|0.33||0.4105|TWO_SIDED|90.0|-0.27|0.81|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-B (Total Damage)||0.81|-0.27|0.4105
91625677|NCT03371251|183144064|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|4.11||0.8546|TWO_SIDED|90.0|-6.07|7.58|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 210||7.58|-6.07|0.8546
91625678|NCT03371251|183144065|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4455|TWO_SIDED|90.0|-0.63|1.71|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Swelling for Day 210||1.71|-0.63|0.4455
91625679|NCT03371251|183144065|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.9|STANDARD_ERROR_OF_MEAN|0.94||0.3367|TWO_SIDED|90.0|-0.65|2.47|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Tenderness for Day 210||2.47|-0.65|0.3367
91625680|NCT03371251|183144065|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.66||0.255|TWO_SIDED|90.0|-0.34|1.86|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Active Joints for Day 210||1.86|-0.34|0.2550
91625681|NCT03371251|183144066|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.68||0.2498|TWO_SIDED|90.0|-0.34|1.93|||ANCOVA||This is based on LS Means|||1.93|-0.34|0.2498
91625682|NCT03371251|183144067|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.2558|TWO_SIDED|90.0|-0.02|0.12|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 180||0.12|-0.02|0.2558
91625683|NCT03371251|183144068|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0479|TWO_SIDED|90.0|0.18|0.88|||Log Rank||Hazard rate of BOS161721 120 mg / Hazard rate of placebo|||0.88|0.18|0.0479
91625684|NCT03371251|183144070|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|4.4|STANDARD_ERROR_OF_MEAN|16.4||0.7898|TWO_SIDED|90.0|-22.92|31.7|||ANOVA||This is based on LS Means|||31.70|-22.92|0.7898
91625685|NCT03371251|183144071|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0083|TWO_SIDED|90.0|0.16|0.68|||Log-Rank Test (2-Sided)||Hazard rate of BOS161721 120mg / Hazard rate of placebo|||0.68|0.16|0.0083
91625686|NCT00294684|183144073|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.43|TWO_SIDED|95.0|0.83|1.57|||Log binomial|||RR greater than one indicates benefit of steriods and a P value of treatment success from a log-binomial model with these covariates: Treatment group, age a HPE, BASM as fixed effects, and site as a random effect.||1.57|0.83|0.43
91662606|NCT00796653|183220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.112|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.112|<0.0001
91662607|NCT00796653|183220780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.104|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.183|0.104|<0.0001
91525177|NCT00856934|182925721|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
91525178|NCT00856934|182925722|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
91525179|NCT03285295|182925723|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
91525180|NCT03285295|182925724|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.15|100.0|||Sensitivity|||||100.00|99.15|
91625687|NCT00294684|183144074|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.6|1.8|||Regression, Cox|||||1.8|0.6|0.99
91625688|NCT00294684|183144075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6||||0.0973|TWO_SIDED|95.0|-3.49|0.3|||Mixed Models Analysis|||LS Mean difference reported as steroid minus placebo (negative values mean larger average values of total bilirubin in placebo).||0.3|-3.49|0.0973
91625689|NCT00294684|183144076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.3||||0.0552|TWO_SIDED|95.0|-4.65|0.05|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average values of bilirubin in placebo)||0.05|-4.65|0.0552
91625690|NCT00294684|183144077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.39||||0.6607||95.0|-2.16|1.38|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average bilirubin in placebo)||1.38|-2.16|0.6607
91625691|NCT00294684|183144078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1603|||||||Mixed Models Analysis|||||||0.1603
91625692|NCT00294684|183144079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2801|||||||Mixed Models Analysis|||||||0.2801
91625693|NCT00294684|183144080|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.4||||0.41|TWO_SIDED|95.0|0.62|3.14|||Log Binomial|||||3.14|0.62|0.41
91625694|NCT00294684|183144081|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.3||||0.29|TWO_SIDED|95.0|0.03|2.92|||Log Binomial|||||2.92|0.03|0.29
91625695|NCT01515488|183144098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.3|STANDARD_ERROR_OF_MEAN|5.2|<|0.0005|TWO_SIDED|95.0|22.1|42.6|||t-test, 2 sided|DF=331.2||||42.6|22.1|<0.0005
91713925|NCT03416270|183319468|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91713926|NCT03416270|183319469|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||||||0.405
91713927|NCT03416270|183319470|OTHER|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||0.536
91662608|NCT00796653|183220781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.071|0.152|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.152|0.071|<0.0001
91662609|NCT00796653|183220781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.086|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.086|<0.0001
91662610|NCT00796653|183220781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.078|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.158|0.078|<0.0001
91662611|NCT00796653|183220782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.162|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.162|<0.0001
91662612|NCT00796653|183220782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.182|<0.0001
91662613|NCT00796653|183220782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.198|0.334|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.334|0.198|<0.0001
91662614|NCT00796653|183220783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.320|0.182|<0.0001
91662615|NCT00796653|183220783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.18|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.180|<0.0001
91662616|NCT00796653|183220783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.350|0.212|<0.0001
91662617|NCT00796653|183220784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.159|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.159|<0.0001
91662618|NCT00796653|183220784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.177|0.317|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.317|0.177|<0.0001
91662619|NCT00796653|183220784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.205|0.345|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.345|0.205|<0.0001
91662620|NCT00796653|183220785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.128|0.27|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.270|0.128|<0.0001
91662621|NCT00796653|183220785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.142|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.283|0.142|<0.0001
91662622|NCT00796653|183220785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.17|0.312|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.312|0.170|<0.0001
91662623|NCT00796653|183220786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.146|0.29|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.290|0.146|<0.0001
91662624|NCT00796653|183220786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.166|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.166|<0.0001
91662625|NCT00796653|183220786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.292|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.292|0.148|<0.0001
91525181|NCT03285295|182925725|SUPERIORITY||Clinical Specificity (%)|99.99|||||TWO_SIDED|95.0|99.95|100.0|||Binomial Distribution|||||100.00|99.95|
91662626|NCT00796653|183220787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.035||0.0133||95.0|0.018|0.157|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.157|0.018|0.0133
91662627|NCT00796653|183220787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.073|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.073|<0.0001
91662628|NCT00796653|183220787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.035||0.0212||95.0|0.012|0.151|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.151|0.012|0.0212
91713928|NCT03416270|183319471|OTHER|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
91713929|NCT03416270|183319472|OTHER|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
91713930|NCT03416270|183319473|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91713931|NCT03416270|183319474|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
91713932|NCT03416270|183319475|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
91625696|NCT01248364|183144106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.279|TWO_SIDED|95.0|-0.16|0.55|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.55|-0.16|0.2790
91662629|NCT00796653|183220788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.036||0.0004||95.0|0.057|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.057|0.0004
91662630|NCT00796653|183220788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.036||0.0012||95.0|0.045|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.185|0.045|0.0012
91713933|NCT03416270|183319476|OTHER|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||||||0.802
91713934|NCT03416270|183319477|OTHER|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
91713935|NCT03416270|183319478|OTHER|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
91791983|NCT05171816|183461785|OTHER|Exploratory|Hazard Ratio (HR)|0.68||||0.4937|TWO_SIDED|95.0|0.2|2.06||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.06|0.20|0.4937
91525182|NCT03285295|182925726|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.48|100.0|||Sensitivity|||||100.00|99.48|
91662631|NCT00796653|183220788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0056||95.0|0.029|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.169|0.029|0.0056
91625697|NCT01248364|183144107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2438|TWO_SIDED|95.0|-0.16|0.62|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.62|-0.16|0.2438
91713936|NCT03416270|183319479|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
91713937|NCT03416270|183319480|OTHER|||||||0.53||||||12 week|Wilcoxon (Mann-Whitney)|||||||0.53
91713938|NCT03416270|183319480|OTHER|||||||0.89||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.89
91713939|NCT03416270|183319481|OTHER|||||||0.26||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.26
91713940|NCT03416270|183319481|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
91713941|NCT04556760|183319542|OTHER||Mean Difference (Final Values)|-132.9528||||0.036|TWO_SIDED|95.0|-256.5082|-9.3973|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-9.3973|-256.5082|0.036
91525183|NCT03285295|182925727|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.86|99.95|||Binomial Distribution|||||99.95|99.86|
91525184|NCT03285295|182925728|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
91713942|NCT04556760|183319542|OTHER||Mean Difference (Final Values)|-142.033||||0.432|TWO_SIDED|95.0|-554.8722|270.8061|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||270.8061|-554.8722|0.432
91713943|NCT04556760|183319542|OTHER||Mean Difference (Final Values)|-126.8829||||0.03|TWO_SIDED|95.0|-236.0426|-17.7233|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||-17.7233|-236.0426|0.030
91713944|NCT04556760|183319543|OTHER||Mean Difference (Final Values)|-1.5067|||<|0.001|TWO_SIDED|95.0|-2.082|-0.9314|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-0.9314|-2.0820|<0.001
91713945|NCT04556760|183319543|OTHER||Mean Difference (Final Values)|-1.1099|||<|0.001|TWO_SIDED|95.0|-1.7257|-0.4941|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||-0.4941|-1.7257|<0.001
91713946|NCT04556760|183319543|OTHER||Mean Difference (Final Values)|-0.1601||||0.547||95.0|-0.693|0.3729|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3729|-0.6930|0.547
91713947|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-1.5015|||<|0.001|TWO_SIDED|95.0|-2.2258|-0.7773|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[00 to 24 h\])||-0.7773|-2.2258|<0.001
91713948|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-1.8643|||<|0.001||95.0|-2.5611|-1.1674|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[24 to 48 h\])||-1.1674|-2.5611|<0.001
91713949|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-1.5998|||<|0.001|TWO_SIDED|95.0|-2.3025|-0.8971|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[48 to 72 h\])||-0.8971|-2.3025|<0.001
91713950|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-0.8474||||0.013|TWO_SIDED|95.0|-1.4465|-0.2484|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[00 to 24 h\])||-0.2484|-1.4465|0.013
91525185|NCT03285295|182925729|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.87|99.96|||Binomial Exact|||||99.96|99.87|
91525186|NCT03285295|182925730|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.72|100.0|||Sensitivity|||||100.00|99.72|
91625698|NCT01248364|183144108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6931|TWO_SIDED|95.0|-1.19|1.79|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||1.79|-1.19|0.6931
91625699|NCT01248364|183144109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|1.12||0.1028|TWO_SIDED|95.0|-0.38|4.07|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||4.07|-0.38|0.1028
91625700|NCT01248364|183144110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|2.52||0.0326|TWO_SIDED|95.0|0.47|10.5|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||10.50|0.47|0.0326
91625701|NCT01248364|183144111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.81||0.0552|TWO_SIDED|95.0|-3.2|0.04|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.04|-3.20|0.0552
91625702|NCT01248364|183144112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.99||0.7561|TWO_SIDED|95.0|-1.66|2.27|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||2.27|-1.66|0.7561
91625703|NCT01248364|183144113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13|STANDARD_ERROR_OF_MEAN|1.89||0.1024|TWO_SIDED|95.0|-0.64|6.9|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||6.90|-0.64|0.1024
91625704|NCT01248364|183144114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|2.93||0.6576|TWO_SIDED|95.0|-4.53|7.14|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||7.14|-4.53|0.6576
91625705|NCT01248364|183144115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|3.38||0.2795|TWO_SIDED|95.0|-10.41|3.05|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||3.05|-10.41|0.2795
91625706|NCT00996593|183144119|SUPERIORITY_OR_OTHER||Percentage of participants|65.0|||||TWO_SIDED|95.0|50.0|80.0|||||The estimated value represents the percentage of participants with complete response.|||80|50|
91625707|NCT00996593|183144120|SUPERIORITY_OR_OTHER||Percentage of participants|23.0|||||TWO_SIDED|95.0|10.0|35.0|||||The estimated value represents the percentage of participants with complete response.|||35|10|
91625708|NCT00996593|183144121|SUPERIORITY_OR_OTHER||Percentage of participants|38.0|||||TWO_SIDED|95.0|22.0|53.0|||||The estimated value represents the percentage of participants with complete response.|||53|22|
91662632|NCT00796653|183220789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.036||0.0045||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.032|0.0045
91662633|NCT00796653|183220789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.036||0.0046||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.173|0.032|0.0046
91525187|NCT03285295|182925731|SUPERIORITY||Clinical Specificity (%)|99.9|||||TWO_SIDED|95.0|99.84|99.94|||Binomial Exact|||||99.94|99.84|
91525188|NCT03285295|182925732|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
91525189|NCT03285295|182925733|SUPERIORITY||Clinical Specificity (%)|99.98|||||TWO_SIDED|95.0|99.94|100.0|||Binomial Exact|||||100.00|99.94|
91525190|NCT03285295|182925734|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|98.85|100.0|||Sensitivity|||||100.00|98.85|
91525191|NCT03285295|182925739|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|95.98|100.0|||Sensitivity|||Sensitivity||100.00|95.98|
91525192|NCT03285295|182925741|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|92.75|100.0|||Sensitivity|||Sensitivity||100.00|92.75|
91625709|NCT00996593|183144122|SUPERIORITY_OR_OTHER||Percentage of participants|28.0|||||TWO_SIDED|95.0|14.0|41.0|||||The estimated value represents the percentage of participants with complete response.|||41|14|
91625710|NCT00996593|183144127|SUPERIORITY_OR_OTHER||Percentage of responders|75.0||||1|TWO_SIDED|95.0|54.0|96.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||96|54|1.0
91625711|NCT00996593|183144127|SUPERIORITY_OR_OTHER||Percentage of responders|70.0||||1|TWO_SIDED|95.0|51.0|88.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||88|51|1.0
91625712|NCT00996593|183144128|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Fisher Exact|||||||0.8
91625713|NCT00996593|183144129|SUPERIORITY_OR_OTHER||Percentage of responders|31.0||||1|TWO_SIDED|95.0|9.0|54.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||54|9|1.0
91625714|NCT00996593|183144129|SUPERIORITY_OR_OTHER||Percentage of responders|17.0||||1|TWO_SIDED|95.0|2.0|33.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||33|2|1.0
91482018|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91525193|NCT03285295|182925742|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
91625715|NCT00996593|183144130|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
91625716|NCT00996593|183144131|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Log Rank|||||||0.9
91625717|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0507|STANDARD_ERROR_OF_MEAN|0.0339|||ONE_SIDED|90.0|0.0059||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90 percent (%) confidence interval (CI) was reported.|||0.0059|
91625718|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0788|STANDARD_ERROR_OF_MEAN|0.027|||ONE_SIDED|90.0|0.0431||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0431|
91625719|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0927|STANDARD_ERROR_OF_MEAN|0.0277|||ONE_SIDED|90.0|0.056||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0560|
91625720|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0613|STANDARD_ERROR_OF_MEAN|0.03|||ONE_SIDED|90.0|0.0215||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0215|
91625721|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0105|STANDARD_ERROR_OF_MEAN|0.0309|||ONE_SIDED|80.0|-0.0371||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0371|
91625722|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0175|STANDARD_ERROR_OF_MEAN|0.0246|||ONE_SIDED|80.0|-0.0037||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0037|
91625723|NCT01033487|183144144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0315|STANDARD_ERROR_OF_MEAN|0.0294|||ONE_SIDED|80.0|0.0062||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||0.0062|
91625724|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0989|STANDARD_ERROR_OF_MEAN|0.242|||ONE_SIDED|90.0|0.0676||||ANOVA|||Mixed effects analysis of variance (ANOVA) was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0676|
91625725|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1748|STANDARD_ERROR_OF_MEAN|0.0245|||ONE_SIDED|90.0|0.1431||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1431|
91625726|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1909|STANDARD_ERROR_OF_MEAN|0.0243|||ONE_SIDED|90.0|0.1594||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1594|
91713951|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-0.7778||||0.061|TWO_SIDED|95.0|-1.6022|0.0466|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[24 to 48 h\])||0.0466|-1.6022|0.061
91625727|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1528|STANDARD_ERROR_OF_MEAN|0.0237|||ONE_SIDED|90.0|0.1222||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1222|
91625728|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0539|STANDARD_ERROR_OF_MEAN|0.0239|||ONE_SIDED|90.0|-0.0849||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0849|
91625729|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_DEVIATION|0.0238|||ONE_SIDED|90.0|-0.0088||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0088|
91625730|NCT01033487|183144153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.0242|||ONE_SIDED|90.0|0.0068||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0068|
91625731|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0852|STANDARD_ERROR_OF_MEAN|0.0214|||ONE_SIDED|90.0|0.0576||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0576|
91625732|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1418|STANDARD_ERROR_OF_MEAN|0.0219|||ONE_SIDED|90.0|0.1136||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1136|
91482019|NCT00245219|182838062|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91525194|NCT03285295|182925743|OTHER|95% Confidence Interval provided.|Point Estimate|98.65|||||TWO_SIDED|95.0|95.2|99.84|||Sensitivity|||Sensitivity||99.84|95.20|
91713952|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-1.143||||0.003|TWO_SIDED|95.0|-1.7622|-0.5238|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[48 to 72 h\])||-0.5238|-1.7622|0.003
91713953|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-0.36||||0.125|TWO_SIDED|95.0|-0.8338|0.1138|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[00 to 24 h\])||0.1138|-0.8338|0.125
91713954|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-0.0845||||0.84|TWO_SIDED|95.0|-0.9706|0.8016|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[24 to 48 h\])||0.8016|-0.9706|0.840
91713955|NCT04556760|183319544|OTHER||Mean Difference (Final Values)|-0.1298||||0.571|TWO_SIDED|95.0|-0.646|0.3864|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[48 to 72 h\])||0.3864|-0.6460|0.571
91525195|NCT04867785|182925757|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.188|TWO_SIDED|95.0|-0.94|0.18|||Mixed Models Analysis|||||0.18|-0.94|0.188
91625733|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1692|STANDARD_ERROR_OF_MEAN|0.0216|||ONE_SIDED|90.0|0.1413||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1413|
91625734|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1526|STANDARD_ERROR_OF_MEAN|0.0212|||ONE_SIDED|90.0|0.1252||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1252|
91625735|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0674|STANDARD_ERROR_OF_MEAN|0.0211|||ONE_SIDED|90.0|-0.0946||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0946|
91625736|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0108|STANDARD_ERROR_OF_MEAN|0.0213|||ONE_SIDED|90.0|-0.0383||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0383|
91625737|NCT01033487|183144154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0166|STANDARD_ERROR_OF_MEAN|0.213|||ONE_SIDED|90.0|-0.011||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0110|
91625738|NCT00735670|183144193|SUPERIORITY_OR_OTHER|||||||0.445|||||||Fisher Exact|||||||0.445
91625739|NCT00735670|183144194|SUPERIORITY_OR_OTHER||REML|-0.31||||0.725|TWO_SIDED|95.0|-0.48|-0.15||Comparison of venlafaxine vs. placebo on change of PHQ-9 over time controlling for baseline PHQ-9 score.|Mixed Models Analysis|||A linear mixed model (LMM) analysis was used and included a random intercept effect based on lowest Akaike's Information Criterion values when we compared three random coefficient models (intercept, slope and intercept and slope). To examine whether allocation group influenced the effect of time and baseline PHQ-9 sore on the trajectory of PHQ-9 scores, we included two interaction terms (time by allocation group and baseline PHQ-9 score by allocation group).||-0.15|-0.48|0.725
91625740|NCT00187889|183144199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6|STANDARD_ERROR_OF_MEAN|6.7||0.15|TWO_SIDED|95.0|-22.8|3.6||The P-value applies to this comparison, without adjustment, to the completers of the trial.|Satterthwaite corrected t-test||An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.|The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.||3.6|-22.8|0.15
91625741|NCT00187889|183144199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.39||0.92|TWO_SIDED|95.0|-0.79|0.72|||Satterthwaite corrected t-test||The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.|The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.||0.72|-0.79|0.92
91625742|NCT04046341|183144205|OTHER|||||||0.008||||||A priori statistical significance threshold = p\<.05|McNemar|||||||.008
91625743|NCT04046341|183144206|SUPERIORITY|||||||0.014||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.014
91625744|NCT04046341|183144207|SUPERIORITY|||||||0.013||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.013
91625745|NCT04046341|183144208|SUPERIORITY|||||||0.001||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.001
91625746|NCT04046341|183144209|SUPERIORITY|||||||0.209||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.209
91625747|NCT03954444|183144215|EQUIVALENCE|90% Confidence Interval, should be within -20% to +20%|Mean Difference (Net)|2.7|||||TWO_SIDED|90.0|-2.6|8.0||||||||8.0|-2.6|
91525196|NCT04867785|182925757|SUPERIORITY||LSMean Difference|-1.34|||<|0.001|TWO_SIDED|95.0|-1.84|-0.85|||Mixed Models Analysis|||||-0.85|-1.84|<0.001
91625748|NCT03954444|183144215|SUPERIORITY|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
91625749|NCT03954444|183144215|SUPERIORITY|||||||0.1126|||||||Cochran-Mantel-Haenszel|||||||0.1126
91625750|NCT00435994|183144246|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.0020
91625751|NCT00435994|183144247|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||.0020
91713956|NCT04556760|183319545|OTHER||Mean Difference (Final Values)|-0.07||||0.753|TWO_SIDED|95.0|-0.55|0.4|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.40|-0.55|0.753
91525197|NCT04867785|182925757|SUPERIORITY||LSMean Difference|-1.25|||<|0.001|TWO_SIDED|95.0|-1.85|-0.65|||Mixed Models Analysis|||||-0.65|-1.85|<0.001
91525198|NCT04867785|182925757|SUPERIORITY||LSMean Difference|-1.94|||<|0.001|TWO_SIDED|95.0|-2.44|-1.43|||Mixed Models Analysis|||||-1.43|-2.44|<0.001
91525199|NCT04867785|182925757|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.42|-1.24|||Mixed Models Analysis|||||-1.24|-2.42|<0.001
91713957|NCT04556760|183319545|OTHER||Mean Difference (Final Values)|-0.04||||0.802|TWO_SIDED|95.0|-0.46|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.37|-0.46|0.802
91713958|NCT04556760|183319545|OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-0.37|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.37|-0.37|0.985
91713959|NCT04556760|183319546|OTHER||Mean Difference (Final Values)|20498.7|||<|0.001|TWO_SIDED|95.0|10819.2|30178.2|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||30178.2|10819.2|<0.001
91625752|NCT03846219|183144261|SUPERIORITY||rate ratio|0.38||||0.0002|TWO_SIDED|95.0|0.22|0.64||A one-sided alpha level of 0.1 was used.|generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 45 mg IMU-838 / placebo|H0: cumulative number of CUA MRI lesions up to Week 24 with 45 mg IMU-838 equal to or higher than that with placebo. A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term. 51 patients per group were necessary to have 80% power to detect a difference of 3.5 in mean event rate with a significance level 0.1, 1-sided.||0.64|0.22|0.0002
91791984|NCT05171816|183461786|OTHER|Exploratory|Hazard Ratio (HR)|1.65||||0.4923|TWO_SIDED|95.0|0.61|4.87||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||4.87|0.61|0.4923
91625753|NCT03846219|183144262|SUPERIORITY||Rate ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53||A hierarchical testing procedure with a one-sided alpha level of 0.1 was used.|Generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 30 mg IMU-838 / placebo|A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term.||0.53|0.17|<.0001
91625754|NCT05109702|183144318|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.094||0.764|TWO_SIDED|95.0|-0.214|0.157|||MMRM|||The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.157|-0.214|0.764
91625755|NCT05109702|183144319|SUPERIORITY||LS Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|2.969||0.144|TWO_SIDED|95.0|-1.483|10.155|||MMRM|||The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.155|-1.483|0.144
91625756|NCT05109702|183144320|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.094||0.056|TWO_SIDED|95.0|-0.005|0.363|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.363|-0.005|0.056
91625757|NCT05109702|183144320|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.094||0.064|TWO_SIDED|95.0|-0.01|0.359|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.359|-0.010|0.064
91625758|NCT05109702|183144320|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.095||0.328|TWO_SIDED|95.0|-0.093|0.279|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.279|-0.093|0.328
91625759|NCT05109702|183144320|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.096||0.837|TWO_SIDED|95.0|-0.208|0.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.168|-0.208|0.837
91625760|NCT05109702|183144321|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.686|TWO_SIDED|95.0|-0.123|0.187|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.123|0.686
91625761|NCT05109702|183144321|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.68|TWO_SIDED|95.0|-0.123|0.188|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.188|-0.123|0.680
91662634|NCT00796653|183220789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.036||0.0023||95.0|0.039|0.181|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.181|0.039|0.0023
91662635|NCT00796653|183220790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.037||0.0077||95.0|0.026|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.169|0.026|0.0077
91525200|NCT04867785|182925757|SUPERIORITY||LSMean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.43|-1.5|||Mixed Models Analysis|||||-1.50|-2.43|<0.001
91525201|NCT04867785|182925758|SUPERIORITY||LSMean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.52|1.43|||Mixed Models Analysis|||||1.43|0.52|<0.001
91525202|NCT04867785|182925758|SUPERIORITY||LSMean Difference|0.01||||0.935|TWO_SIDED|95.0|-0.34|0.37|||Mixed Models Analysis|||||0.37|-0.34|0.935
91525203|NCT04867785|182925758|SUPERIORITY||LSMean Difference|0.11||||0.668|TWO_SIDED|95.0|-0.39|0.6|||Mixed Models Analysis|||||0.60|-0.39|0.668
91625762|NCT05109702|183144321|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.529|TWO_SIDED|95.0|-0.107|0.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.207|-0.107|0.529
91662636|NCT00796653|183220790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.036||0.0009||95.0|0.05|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.050|0.0009
91662637|NCT00796653|183220790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0339||95.0|0.006|0.149|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.149|0.006|0.0339
91625763|NCT05109702|183144321|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.081||0.745|TWO_SIDED|95.0|-0.132|0.185|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.185|-0.132|0.745
91625764|NCT05109702|183144322|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.085||0.765|TWO_SIDED|95.0|-0.141|0.192|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.192|-0.141|0.765
91625765|NCT05109702|183144322|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.085||0.053|TWO_SIDED|95.0|-0.002|0.331|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.331|-0.002|0.053
91625766|NCT05109702|183144322|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.552|TWO_SIDED|95.0|-0.117|0.219|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.219|-0.117|0.552
91662638|NCT00796653|183220791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.037||0.0718||95.0|-0.006|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.006|0.0718
91662639|NCT00796653|183220791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.037||0.0863||95.0|-0.009|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.135|-0.009|0.0863
91713960|NCT04556760|183319546|OTHER||Mean Difference (Final Values)|3321.4||||0.659|TWO_SIDED|95.0|-12975.8|19618.6|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||19618.6|-12975.8|0.659
91713961|NCT04556760|183319546|OTHER||Mean Difference (Final Values)|-2698.8||||0.521|TWO_SIDED|95.0|-14849.0|9451.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9451.3|-14849.0|0.521
91713962|NCT04556760|183319547|OTHER||Mean Difference (Final Values)|-1002.5864||||0.003|TWO_SIDED|95.0|-1620.215|-384.9577|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-384.9577|-1620.2150|0.003
91525204|NCT04867785|182925758|SUPERIORITY||LSMean Difference|-0.58||||0.002|TWO_SIDED|95.0|-0.95|-0.21|||Mixed Models Analysis|||||-0.21|-0.95|0.002
91713963|NCT04556760|183319547|OTHER||Mean Difference (Final Values)|40.9836||||0.865|TWO_SIDED|95.0|-526.6968|608.664|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||608.6640|-526.6968|0.865
91525205|NCT04867785|182925758|SUPERIORITY||LSMean Difference|-0.47||||0.056|TWO_SIDED|95.0|-0.95|0.01|||Mixed Models Analysis|||||0.01|-0.95|0.056
91525206|NCT04867785|182925758|SUPERIORITY||LSMean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.93|-0.29|||Mixed Models Analysis|||||-0.29|-0.93|<0.001
91525207|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-0.24||||0.448|TWO_SIDED|95.0|-0.85|0.38|||Mixed Models Analysis|||||0.38|-0.85|0.448
91525208|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-0.99||||0.001|TWO_SIDED|95.0|-1.6|-0.38|||Mixed Models Analysis|||||-0.38|-1.60|0.001
91525209|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.8|-0.59|||Mixed Models Analysis|||||-0.59|-1.80|<0.001
91525210|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.41|-1.24|||Mixed Models Analysis|||||-1.24|-2.41|<0.001
91525211|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-1.63|||<|0.001|TWO_SIDED|95.0|-2.27|-0.99|||Mixed Models Analysis|||||-0.99|-2.27|<0.001
91525212|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.39|-1.31|||Mixed Models Analysis|||||-1.31|-2.39|<0.001
91525213|NCT04867785|182925759|SUPERIORITY||LSMean Difference|0.82|||<|0.001|TWO_SIDED|95.0|0.35|1.29|||Mixed Models Analysis|||||1.29|0.35|<0.001
91525214|NCT04867785|182925759|SUPERIORITY||LSMean Difference|0.06||||0.796|TWO_SIDED|95.0|-0.41|0.53|||Mixed Models Analysis|||||0.53|-0.41|0.796
91625767|NCT05109702|183144322|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.087||0.593|TWO_SIDED|95.0|-0.216|0.124|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.124|-0.216|0.593
91625768|NCT05109702|183144323|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.087||0.884|TWO_SIDED|95.0|-0.183|0.158|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.158|-0.183|0.884
91625769|NCT05109702|183144323|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.474|TWO_SIDED|95.0|-0.109|0.233|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.233|-0.109|0.474
91625770|NCT05109702|183144323|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.088||0.202|TWO_SIDED|95.0|-0.06|0.285|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.285|-0.060|0.202
91625771|NCT05109702|183144323|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.089||0.013|TWO_SIDED|95.0|0.047|0.396|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.396|0.047|0.013
91625772|NCT05109702|183144324|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.604|TWO_SIDED|95.0|-0.131|0.224|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.224|-0.131|0.604
91625773|NCT05109702|183144324|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.091||0.519|TWO_SIDED|95.0|-0.119|0.236|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.236|-0.119|0.519
91625774|NCT05109702|183144324|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.299|TWO_SIDED|95.0|-0.085|0.275|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.275|-0.085|0.299
91625775|NCT05109702|183144324|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.093||0.124|TWO_SIDED|95.0|-0.039|0.324|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.324|-0.039|0.124
91625776|NCT05109702|183144325|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.215||0.293|TWO_SIDED|95.0|-0.196|0.647|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.647|-0.196|0.293
91625777|NCT05109702|183144325|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.215||0.094|TWO_SIDED|95.0|-0.062|0.783|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.783|-0.062|0.094
91625778|NCT05109702|183144325|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.217||0.404|TWO_SIDED|95.0|-0.245|0.608|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.608|-0.245|0.404
91625779|NCT05109702|183144325|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.806|TWO_SIDED|95.0|-0.485|0.377|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.377|-0.485|0.806
91662640|NCT00796653|183220791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.2982||95.0|-0.034|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.111|-0.034|0.2982
91662641|NCT00796653|183220792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.019||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0190
91662642|NCT00796653|183220792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0601||95.0|-0.003|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.003|0.0601
91662643|NCT00796653|183220792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.037||0.2573||95.0|-0.031|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.115|-0.031|0.2573
91662644|NCT00796653|183220793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.02||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0200
91482020|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91482021|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91525215|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-0.14||||0.548|TWO_SIDED|95.0|-0.61|0.32|||Mixed Models Analysis|||||0.32|-0.61|0.548
91662645|NCT00796653|183220793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.047|0.0013
91662646|NCT00796653|183220793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.037||0.1598||95.0|-0.021|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.126|-0.021|0.1598
91662647|NCT00796653|183220794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.038||0.0307||95.0|0.008|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.155|0.008|0.0307
91662648|NCT00796653|183220794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.038||0.0073||95.0|0.027|0.175|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.175|0.027|0.0073
91525216|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.19|-0.36|||Mixed Models Analysis|||||-0.36|-1.19|<0.001
91662649|NCT00796653|183220794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.038||0.3147||95.0|-0.036|0.112|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.112|-0.036|0.3147
91662650|NCT00796653|183220795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.16|0.306|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.306|0.160|<0.0001
91713964|NCT04556760|183319547|OTHER||Mean Difference (Final Values)|101.4137||||0.754|TWO_SIDED|95.0|-628.8097|831.637|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||831.6370|-628.8097|0.754
91482022|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91525217|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-0.57||||0.025|TWO_SIDED|95.0|-1.08|-0.07|||Mixed Models Analysis|||||-0.07|-1.08|0.025
91525218|NCT04867785|182925759|SUPERIORITY||LSMean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.16|-0.44|||Mixed Models Analysis|||||-0.44|-1.16|<0.001
91525219|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.14||||0.121|TWO_SIDED|95.0|-0.04|0.32|||Regression, Logistic|||||0.32|-0.04|0.121
91525220|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.36||||0.002|TWO_SIDED|95.0|0.13|0.59|||Regression, Logistic|||||0.59|0.13|0.002
91525221|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.48|||<|0.001|TWO_SIDED|95.0|0.28|0.68|||Regression, Logistic|||||0.68|0.28|<0.001
91662651|NCT00796653|183220795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.156|0.302|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.302|0.156|<0.0001
91662652|NCT00796653|183220795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.175|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.321|0.175|<0.0001
91662653|NCT00796653|183220796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.174|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.321|0.174|<0.0001
91662654|NCT00796653|183220796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.295|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.295|0.148|<0.0001
91625780|NCT05109702|183144326|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.157||0.824|TWO_SIDED|95.0|-0.273|0.343|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.343|-0.273|0.824
91625781|NCT05109702|183144326|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.157||0.437|TWO_SIDED|95.0|-0.186|0.431|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.431|-0.186|0.437
91662655|NCT00796653|183220796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.328|0.180|<0.0001
91625782|NCT05109702|183144326|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.159||0.193|TWO_SIDED|95.0|-0.105|0.519|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.519|-0.105|0.193
91625783|NCT05109702|183144326|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.161||0.024|TWO_SIDED|95.0|0.048|0.679|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.679|0.048|0.024
91625784|NCT05109702|183144327|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.43|TWO_SIDED|95.0|-0.386|0.907|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.907|-0.386|0.430
91625785|NCT05109702|183144327|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.33||0.143|TWO_SIDED|95.0|-0.164|1.132|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.132|-0.164|0.143
91662656|NCT00796653|183220797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.141|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.289|0.141|<0.0001
91662657|NCT00796653|183220797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.151|0.3|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.300|0.151|<0.0001
91662658|NCT00796653|183220797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.191|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.340|0.191|<0.0001
91662659|NCT00796653|183220798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.106|<0.0001
91662660|NCT00796653|183220798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.105|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.256|0.105|<0.0001
91713965|NCT04556760|183319548|OTHER||Mean Difference (Final Values)|-1225.905||||0.004|TWO_SIDED|95.0|-2007.2241|-444.5859|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-444.5859|-2007.2241|0.004
91482023|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
91625786|NCT05109702|183144327|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.333||0.245|TWO_SIDED|95.0|-0.267|1.042|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.042|-0.267|0.245
91625787|NCT05109702|183144327|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.337||0.359|TWO_SIDED|95.0|-0.352|0.97|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.970|-0.352|0.359
91625788|NCT05109702|183144328|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.016|TWO_SIDED|95.0|0.03|0.292|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.292|0.030|0.016
91625789|NCT05109702|183144328|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.099|TWO_SIDED|95.0|-0.021|0.242|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.242|-0.021|0.099
91625790|NCT05109702|183144328|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.068||0.493|TWO_SIDED|95.0|-0.086|0.179|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.179|-0.086|0.493
91625791|NCT05109702|183144328|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.068||0.987|TWO_SIDED|95.0|-0.133|0.135|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.135|-0.133|0.987
91625792|NCT05109702|183144329|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.072||0.655|TWO_SIDED|95.0|-0.109|0.173|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.173|-0.109|0.655
91662661|NCT00796653|183220798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.132|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.283|0.132|<0.0001
91662662|NCT00796653|183220799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.111|0.265|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.265|0.111|<0.0001
91662663|NCT00796653|183220799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.138|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.138|<0.0001
91662664|NCT00796653|183220799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.115|0.269|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.269|0.115|<0.0001
91482024|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91662665|NCT00796653|183220800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.707|STANDARD_ERROR_OF_MEAN|4.435||0.0021|TWO_SIDED|95.0|5.004|22.411|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.411|5.004|0.0021
91662666|NCT00796653|183220800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.871|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|12.158|29.584|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||29.584|12.158|<0.0001
91482025|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91482026|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91482027|NCT00245219|182838063|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
91525222|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.001|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||||0.87|0.53|<0.001
91625793|NCT05109702|183144329|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.826|TWO_SIDED|95.0|-0.157|0.125|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.125|-0.157|0.826
91625794|NCT05109702|183144329|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.073||0.861|TWO_SIDED|95.0|-0.155|0.13|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.130|-0.155|0.861
91625795|NCT05109702|183144329|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.073||0.556|TWO_SIDED|95.0|-0.101|0.187|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.101|0.556
91625796|NCT05109702|183144330|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.527|TWO_SIDED|95.0|-0.116|0.226|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.226|-0.116|0.527
91625797|NCT05109702|183144330|SUPERIORITY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.087||0.005|TWO_SIDED|95.0|0.077|0.418|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.418|0.077|0.005
91625798|NCT05109702|183144330|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088||0.92|TWO_SIDED|95.0|-0.164|0.181|||MMRM|||Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.181|-0.164|0.920
91625799|NCT05109702|183144330|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.089||0.286|TWO_SIDED|95.0|-0.08|0.269|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.269|-0.080|0.286
91482028|NCT02021656|182838064|SUPERIORITY||||||<|0.001|||||||Binomial Exact Test|||A sample size of 100 Chinese participants in the treatment naive group provided at least 90% power to detect a 17% improvement in SVR12 rate from the historical control rate of 57% using 2-sided exact one-sample binomial test at significant level of 0.05.||||<0.001
91625800|NCT05109702|183144331|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.098||0.071|TWO_SIDED|95.0|-0.015|0.369|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.369|-0.015|0.071
91713966|NCT04556760|183319548|OTHER||Mean Difference (Final Values)|-466.9802||||0.313|TWO_SIDED|95.0|-1521.5088|587.5485|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||587.5485|-1521.5088|0.313
91525223|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.6|||<|0.001|TWO_SIDED|95.0|0.39|0.82|||Regression, Logistic|||||0.82|0.39|<0.001
91525224|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.68|||<|0.001|TWO_SIDED|95.0|0.51|0.85|||Regression, Logistic|||||0.85|0.51|<0.001
91482029|NCT01827358|182838073|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|315.2|||<|0.001|TWO_SIDED|97.5|49.6|2698.8|||Fisher Exact|||||2698.8|49.6|<0.001
91482030|NCT01827358|182838074|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|39.5|||<|0.001|TWO_SIDED|95.0|5.5|1666.3|||Fisher Exact|||||1666.3|5.5|<0.001
91482031|NCT01827358|182838075|OTHER||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.3|3.28|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||3.28|0.30|0.997
91525225|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|-0.21||||0.03|TWO_SIDED|95.0|-0.39|-0.02|||Regression, Logistic|||||-0.02|-0.39|0.030
91525226|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.01||||0.938|TWO_SIDED|95.0|-0.22|0.24|||Regression, Logistic|||||0.24|-0.22|0.938
91625801|NCT05109702|183144331|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.098||0.384|TWO_SIDED|95.0|-0.107|0.278|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.278|-0.107|0.384
91625802|NCT05109702|183144331|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.391|TWO_SIDED|95.0|-0.109|0.28|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.280|-0.109|0.391
91625803|NCT05109702|183144331|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.802|TWO_SIDED|95.0|-0.171|0.222|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.222|-0.171|0.802
91625804|NCT05109702|183144332|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.098||0.884|TWO_SIDED|95.0|-0.206|0.178|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.178|-0.206|0.884
91625805|NCT05109702|183144332|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.098||0.303|TWO_SIDED|95.0|-0.091|0.293|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.293|-0.091|0.303
91625806|NCT05109702|183144332|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.099||0.554|TWO_SIDED|95.0|-0.135|0.253|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.253|-0.135|0.554
91625807|NCT05109702|183144332|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.051|TWO_SIDED|95.0|-0.001|0.391|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.391|-0.001|0.051
91625808|NCT05109702|183144333|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.17||0.131|TWO_SIDED|95.0|-0.077|0.591|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.591|-0.077|0.131
91662667|NCT00796653|183220800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.249|STANDARD_ERROR_OF_MEAN|4.454||0.0014|TWO_SIDED|95.0|5.506|22.991|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.991|5.506|0.0014
91662668|NCT00796653|183220800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|4.463||0.0001|TWO_SIDED|95.0|8.64|26.16|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||26.160|8.640|0.0001
91662669|NCT00796653|183220800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.875|STANDARD_ERROR_OF_MEAN|4.444|<|0.0001|TWO_SIDED|95.0|14.153|31.596|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||31.596|14.153|<0.0001
91625809|NCT05109702|183144333|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.171||0.04|TWO_SIDED|95.0|0.016|0.685|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.685|0.016|0.040
91625810|NCT05109702|183144333|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.172||0.767|TWO_SIDED|95.0|-0.287|0.389|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.389|-0.287|0.767
91625811|NCT05109702|183144333|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.174||0.41|TWO_SIDED|95.0|-0.198|0.485|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.198|0.410
91625812|NCT05109702|183144334|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.324|TWO_SIDED|95.0|-0.166|0.501|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.501|-0.166|0.324
91625813|NCT05109702|183144334|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.262|TWO_SIDED|95.0|-0.143|0.525|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.525|-0.143|0.262
91625814|NCT05109702|183144334|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.172||0.391|TWO_SIDED|95.0|-0.19|0.485|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.190|0.391
91625815|NCT05109702|183144334|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.174||0.192|TWO_SIDED|95.0|-0.114|0.568|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.568|-0.114|0.192
91662670|NCT00796653|183220800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.816|STANDARD_ERROR_OF_MEAN|4.475||0.0004|TWO_SIDED|95.0|7.032|24.599|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||24.599|7.032|0.0004
91662671|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|STANDARD_ERROR_OF_MEAN|0.121||0.2057|TWO_SIDED|95.0|-0.391|-0.084|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.084|-0.391|0.2057
91662672|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.121||0.0284|TWO_SIDED|95.0|-0.504|-0.028|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.028|-0.504|0.0284
91713967|NCT04556760|183319548|OTHER||Mean Difference (Final Values)|-375.3161||||0.404||95.0|-1433.6265|682.9943|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||682.9943|-1433.6265|0.404
91662673|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.122||0.0685|TWO_SIDED|95.0|-0.461|0.017|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.017|-0.461|0.0685
91791985|NCT05171816|183461788|OTHER|Exploratory|Hazard Ratio (HR)|1.45||||0.3407|TWO_SIDED|95.0|0.63|3.39||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||3.39|0.63|0.3407
91525227|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.13||||0.209|TWO_SIDED|95.0|-0.07|0.33|||Regression, Logistic|||||0.33|-0.07|0.209
91625816|NCT05109702|183144335|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.29||0.14|TWO_SIDED|95.0|-0.141|0.999|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.999|-0.141|0.140
91662674|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.152||0.0674|TWO_SIDED|95.0|-0.576|0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||0.020|-0.576|0.0674
91713968|NCT04556760|183319549|OTHER||Mean Difference (Final Values)|365.6323||||0.608|TWO_SIDED|95.0|-1097.7973|1829.0618|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1829.0618|-1097.7973|0.608
91625817|NCT05109702|183144335|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.291||0.061|TWO_SIDED|95.0|-0.025|1.117|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.117|-0.025|0.061
91625818|NCT05109702|183144335|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.294||0.49|TWO_SIDED|95.0|-0.374|0.78|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.780|-0.374|0.490
91625819|NCT05109702|183144335|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.297||0.212|TWO_SIDED|95.0|-0.212|0.953|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.953|-0.212|0.212
91625820|NCT05109702|183144336|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.784|TWO_SIDED|95.0|-0.134|0.101|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.101|-0.134|0.784
91625821|NCT05109702|183144336|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.324|TWO_SIDED|95.0|-0.058|0.176|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.176|-0.058|0.324
91625822|NCT05109702|183144336|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED|95.0|-0.027|0.21|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.210|-0.027|0.130
91625823|NCT05109702|183144336|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.061||0|TWO_SIDED|95.0|0.11|0.35|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.350|0.110|0.000
91625824|NCT05109702|183144337|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.532|TWO_SIDED|95.0|-0.834|1.613|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.613|-0.834|0.532
91625825|NCT05109702|183144337|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.63||0.252|TWO_SIDED|95.0|-0.515|1.959|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.959|-0.515|0.252
91625826|NCT05109702|183144337|SUPERIORITY||LS Mean Difference|1.98|STANDARD_ERROR_OF_MEAN|0.636||0.002|TWO_SIDED|95.0|0.732|3.231|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||3.231|0.732|0.002
91625827|NCT05109702|183144338|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.167||0.723|TWO_SIDED|95.0|-0.386|0.268|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.268|-0.386|0.723
91662675|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.365|STANDARD_ERROR_OF_MEAN|0.0163||0.0163|TWO_SIDED|95.0|-0.662|-0.067|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.067|-0.662|0.0163
91662676|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.153||0.0364|TWO_SIDED|95.0|-0.62|-0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.020|-0.620|0.0364
91662677|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.254||0.0959|TWO_SIDED|95.0|-0.922|0.075|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.075|-0.922|0.0959
91713969|NCT04556760|183319549|OTHER||Mean Difference (Final Values)|188.236||||0.897|TWO_SIDED|95.0|-3214.3323|3590.8043|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3590.8043|-3214.3323|0.897
91525228|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|0.53|||Regression, Logistic|||||0.53|0.18|<0.001
91482032|NCT01827358|182838076|OTHER||Hazard Ratio (HR)|1.33||||0.656|TWO_SIDED|95.0|0.37|4.76|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||4.76|0.37|0.656
91482033|NCT01827358|182838078|OTHER||Hazard Ratio (HR)|0.23||||0.182|TWO_SIDED|95.0|0.03|2.01|||Cox proportional hazards models|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.01|0.03|0.182
91525229|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.26||||0.024|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||||0.48|0.03|0.024
91625828|NCT05109702|183144338|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.167||0.254|TWO_SIDED|95.0|-0.519|0.137|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.137|-0.519|0.254
91662678|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.616|STANDARD_ERROR_OF_MEAN|0.254||0.0155|TWO_SIDED|95.0|-1.115|-0.117|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.117|-1.115|0.0155
91662679|NCT00796653|183220801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.256||0.0347|TWO_SIDED|95.0|-1.042|-0.039|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.039|-1.042|0.0347
91662680|NCT00796653|183220802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0164||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0164
91662681|NCT00796653|183220802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0196||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0196
91662682|NCT00796653|183220802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0041||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0041
91662683|NCT00796653|183220803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0388||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0388
91482034|NCT01827358|182838079|OTHER||Hazard Ratio (HR)|0.24||||0.198|TWO_SIDED|95.0|0.03|2.12|||Cox proportional hazards model|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.12|0.03|0.198
91482035|NCT02043379|182838086|NON_INFERIORITY_OR_EQUIVALENCE|We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
91525230|NCT04867785|182925760|SUPERIORITY||Risk Difference (RD)|0.33|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Regression, Logistic|||||0.51|0.16|<0.001
91662684|NCT00796653|183220803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0038||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0038
91662685|NCT00796653|183220803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0053||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0053
91662686|NCT00796653|183220804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0555||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.0555
91525231|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.14||||0.169|TWO_SIDED|95.0|-0.06|0.35|||Regression, Logistic|||||0.35|-0.06|0.169
91662687|NCT00796653|183220804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.4|0.0122
91662688|NCT00796653|183220804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0144||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.4|0.0144
91662689|NCT00796653|183220805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5707||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.5707
91662690|NCT00796653|183220805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0814||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0814
91662691|NCT00796653|183220805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7413||95.0|-0.2|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.2|-0.2|0.7413
91662692|NCT00796653|183220806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|STANDARD_ERROR_OF_MEAN|0.305||0.1524||95.0|-0.162|1.036|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.036|-0.162|0.1524
91482036|NCT02043379|182838087|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
91482037|NCT02043379|182838088|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.38
91625829|NCT05109702|183144338|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.169||0.034|TWO_SIDED|95.0|-0.69|-0.028|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||-0.028|-0.690|0.034
91625830|NCT05109702|183144338|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.171||0.64|TWO_SIDED|95.0|-0.255|0.414|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.414|-0.255|0.640
91625831|NCT05109702|183144339|SUPERIORITY|Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.|LS Mean Difference|1.45|STANDARD_DEVIATION|2.893||0.615|TWO_SIDED|95.0|-4.223|7.133|||MMRM|||||7.133|-4.223|0.615
91625832|NCT05109702|183144339|SUPERIORITY||LS Mean Difference|4.81|STANDARD_DEVIATION|2.894||0.097|TWO_SIDED|95.0|-0.866|10.494|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.494|-0.866|0.097
91625833|NCT05109702|183144339|SUPERIORITY||LS Mean Difference|1.06|STANDARD_DEVIATION|2.93||0.718|TWO_SIDED|95.0|-4.69|6.81|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.810|-4.690|0.718
91625834|NCT05109702|183144339|SUPERIORITY||LS Mean Difference|3.09|STANDARD_ERROR_OF_MEAN|2.963||0.298|TWO_SIDED|95.0|-2.728|8.903|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.903|-2.728|0.298
91625835|NCT05109702|183144340|SUPERIORITY||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.814||0.343|TWO_SIDED|95.0|-2.854|8.191|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.191|-2.854|0.343
91625836|NCT05109702|183144340|SUPERIORITY||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|2.814||0.188|TWO_SIDED|95.0|-1.813|9.232|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.232|-1.813|0.188
91662693|NCT00796653|183220806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.706|STANDARD_ERROR_OF_MEAN|0.306||0.0211||95.0|0.106|1.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.307|0.106|0.0211
91791986|NCT04902326|183461792|SUPERIORITY|||||||0.78|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.78
91791987|NCT04902326|183461793|SUPERIORITY|||||||0.64|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.64
91482038|NCT02043379|182838089|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.26||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.26
91482039|NCT02043379|182838090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42|TWO_SIDED|95.0||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||24 hour post-CPB albumin||||0.42
91482040|NCT02043379|182838090|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||a p-value of \<0.05 represents the threshold for test signficance|t-test, 2 sided|||48 hour post CPB albumin||||0.06
91482041|NCT02043379|182838091|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.52
91525232|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.39||||0.001|TWO_SIDED|95.0|0.15|0.63|||Regression, Logistic|||||0.63|0.15|0.001
91662694|NCT00796653|183220806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.307||0.1314||95.0|-0.139|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.139|0.1314
91662695|NCT00796653|183220807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.662|STANDARD_ERROR_OF_MEAN|0.308||0.0319||95.0|0.057|1.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.267|0.057|0.0319
91482042|NCT02043379|182838092|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.81||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||Admit Inotrope Score||||0.81
91625837|NCT05109702|183144340|SUPERIORITY||LS Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|2.849||0.371|TWO_SIDED|95.0|-3.04|8.143|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.143|-3.040|0.371
91625838|NCT05109702|183144340|SUPERIORITY||LS Mean Difference|6.92|STANDARD_ERROR_OF_MEAN|2.883||0.017|TWO_SIDED|95.0|1.259|12.573|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||12.573|1.259|0.017
91625839|NCT05109702|183144341|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.754|TWO_SIDED|95.0|-4.452|6.147|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.147|-4.452|0.754
91625840|NCT05109702|183144341|SUPERIORITY||LS Mean Difference|2.43|STANDARD_ERROR_OF_MEAN|2.7||0.368|TWO_SIDED|95.0|-2.865|7.731|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.731|-2.865|0.368
91625841|NCT05109702|183144341|SUPERIORITY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|2.734||0.621|TWO_SIDED|95.0|-4.014|6.715|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.715|-4.014|0.621
91625842|NCT05109702|183144341|SUPERIORITY||LS Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|2.766||0.087|TWO_SIDED|95.0|-0.688|10.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.168|-0.688|0.087
91625843|NCT05109702|183144342|SUPERIORITY||LS Mean Difference|4.23|STANDARD_ERROR_OF_MEAN|2.646||0.11|TWO_SIDED|95.0|-0.958|9.425|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.425|-0.958|0.110
91625844|NCT05109702|183144342|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|2.647||0.315|TWO_SIDED|95.0|-2.535|7.855|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.855|-2.535|0.315
91662696|NCT00796653|183220807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.31||0.0312||95.0|0.06|1.274|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.274|0.060|0.0312
91662697|NCT00796653|183220807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.311||0.1777||95.0|-0.191|1.029|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.029|-0.191|0.1777
91662698|NCT00796653|183220808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.425|STANDARD_ERROR_OF_MEAN|0.311||0.1714||95.0|-0.184|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.035|-0.184|0.1714
91662699|NCT00796653|183220808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.492|STANDARD_ERROR_OF_MEAN|0.312||0.1142||95.0|-0.119|1.103|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.103|-0.119|0.1142
91482043|NCT02043379|182838092|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.82||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative inotrope score||||0.82
91482044|NCT02043379|182838092|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.9||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative inotrope score||||0.9
91625845|NCT05109702|183144342|SUPERIORITY||LS Mean Difference|2.67|STANDARD_DEVIATION|2.678||0.318|TWO_SIDED|95.0|-2.582|7.928|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.928|-2.582|0.318
91625846|NCT05109702|183144342|SUPERIORITY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.71||0.303|TWO_SIDED|95.0|-2.525|8.111|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.111|-2.525|0.303
91625847|NCT05109702|183144343|SUPERIORITY||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|2.975||0.136|TWO_SIDED|95.0|-1.402|10.273|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||10.273|-1.402|0.136
91625848|NCT05109702|183144343|SUPERIORITY||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.972||0.165|TWO_SIDED|95.0|-1.7|9.966|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.966|-1.700|0.165
91625849|NCT05109702|183144343|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.008||0.665|TWO_SIDED|95.0|-4.6|7.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.207|-4.600|0.665
91625850|NCT05109702|183144343|SUPERIORITY||LS Mean Difference|5.02|STANDARD_ERROR_OF_MEAN|3.043||0.099|TWO_SIDED|95.0|-0.95|10.995|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.995|-0.950|0.099
91625851|NCT05109702|183144344|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.926||0.861|TWO_SIDED|95.0|-5.232|6.254|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.254|-5.232|0.861
91625852|NCT05109702|183144344|SUPERIORITY||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|2.925||0.548|TWO_SIDED|95.0|-3.983|7.497|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.497|-3.983|0.548
91625853|NCT05109702|183144344|SUPERIORITY||LS Mean Difference|3.97|STANDARD_ERROR_OF_MEAN|2.96||0.18|TWO_SIDED|95.0|-1.839|9.777|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.777|-1.839|0.180
91625854|NCT05109702|183144344|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.993||0.189|TWO_SIDED|95.0|-1.941|9.807|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.807|-1.941|0.189
91625855|NCT05109702|183144345|SUPERIORITY||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|2.608||0.613|TWO_SIDED|95.0|-3.799|6.438|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.438|-3.799|0.613
91482045|NCT02043379|182838092|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.23||||||a p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||48 hours post-operative inotrope score||||0.23
91482046|NCT02043379|182838093|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.49||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.49
91482047|NCT02043379|182838094|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.79
91713970|NCT04556760|183319549|OTHER||Mean Difference (Final Values)|-1061.4494||||0.381||95.0|-3588.2233|1465.3244|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||1465.3244|-3588.2233|0.381
91482048|NCT02043379|182838095|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.32||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative IgG level||||0.32
91625856|NCT05109702|183144345|SUPERIORITY||LS Mean Difference|4.53|STANDARD_ERROR_OF_MEAN|2.609||0.083|TWO_SIDED|95.0|-0.586|9.653|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.653|-0.586|0.083
91625857|NCT05109702|183144345|SUPERIORITY||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|2.639||0.165|TWO_SIDED|95.0|-1.508|8.851|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.851|-1.508|0.165
91625858|NCT05109702|183144345|SUPERIORITY||LS Mean Difference|4.28|STANDARD_ERROR_OF_MEAN|2.672||0.11|TWO_SIDED|95.0|-0.964|9.522|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.522|-0.964|0.110
91625859|NCT05109702|183144346|SUPERIORITY||LS Mean Difference|3.57|STANDARD_ERROR_OF_MEAN|1.743||0.041|TWO_SIDED|95.0|0.154|6.994|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.994|0.154|0.041
91625860|NCT05109702|183144346|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.743||0.122|TWO_SIDED|95.0|-0.723|6.118|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.118|-0.723|0.122
91625861|NCT05109702|183144346|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.76||0.009|TWO_SIDED|95.0|1.146|8.056|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.056|1.146|0.009
91625862|NCT05109702|183144346|SUPERIORITY||LS Mean Difference|4.04|STANDARD_ERROR_OF_MEAN|1.781||0.024|TWO_SIDED|95.0|0.544|7.536|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.536|0.544|0.024
91625863|NCT05109702|183144347|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.282|TWO_SIDED|95.0|-0.115|0.394|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.115|0.282
91625864|NCT05109702|183144347|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.353|TWO_SIDED|95.0|-0.134|0.375|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.375|-0.134|0.353
91625865|NCT05109702|183144347|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.131||0.764|TWO_SIDED|95.0|-0.297|0.218|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.218|-0.297|0.764
91625866|NCT05109702|183144347|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.133||0.104|TWO_SIDED|95.0|-0.044|0.476|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.476|-0.044|0.104
91525233|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.37||||0.002|TWO_SIDED|95.0|0.14|0.6|||Regression, Logistic|||||0.60|0.14|0.002
91625867|NCT05109702|183144348|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.969|TWO_SIDED|95.0|-0.3|0.288|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.288|-0.300|0.969
91625868|NCT05109702|183144348|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.504|TWO_SIDED|95.0|-0.194|0.394|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.194|0.504
91625869|NCT05109702|183144348|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.152||0.915|TWO_SIDED|95.0|-0.281|0.314|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.314|-0.281|0.915
91662700|NCT00796653|183220808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.314||0.0888||95.0|-0.081|1.15|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.150|-0.081|0.0888
91662701|NCT00796653|183220809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.318||0.1235||95.0|-0.134|1.113|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.113|-0.134|0.1235
91662702|NCT00796653|183220809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.318||0.2666||95.0|-0.271|0.978|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.978|-0.271|0.2666
91662703|NCT00796653|183220809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.319||0.3335||95.0|-0.317|0.934|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.934|-0.317|0.3335
91662704|NCT00796653|183220810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.313|STANDARD_ERROR_OF_MEAN|0.32||0.3287||95.0|-0.315|0.941|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.941|-0.315|0.3287
91625870|NCT05109702|183144348|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.153||0.195|TWO_SIDED|95.0|-0.102|0.499|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.499|-0.102|0.195
91662705|NCT00796653|183220810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.321||0.1341||95.0|-0.148|1.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.109|-0.148|0.1341
91662706|NCT00796653|183220810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.322||0.722||95.0|-0.516|0.745|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.745|-0.516|0.7220
91662707|NCT00796653|183220811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.397|STANDARD_ERROR_OF_MEAN|0.322||0.2176||95.0|-0.234|1.027|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.027|-0.234|0.2176
91713971|NCT04556760|183319550|OTHER||Mean Difference (Final Values)|60.4211|||<|0.001||95.0|29.4904|91.3518|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||91.3518|29.4904|<0.001
91482049|NCT02043379|182838095|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.36||||||a p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative IgG level||||0.36
91525234|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.59|||<|0.001|TWO_SIDED|95.0|0.39|0.79|||Regression, Logistic|||||0.79|0.39|<0.001
91662708|NCT00796653|183220811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|STANDARD_ERROR_OF_MEAN|0.323||0.0258||95.0|0.087|1.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.348|0.087|0.0258
91662709|NCT00796653|183220811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.323||0.6044||95.0|-0.466|0.8|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.800|-0.466|0.6044
91662710|NCT00796653|183220812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.802|STANDARD_ERROR_OF_MEAN|0.133||0.1946||95.0|0.58|1.111|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.111|0.580|0.1946
91662711|NCT00796653|183220812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|STANDARD_ERROR_OF_MEAN|0.141||0.4071||95.0|0.634|1.198|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.198|0.634|0.4071
91662712|NCT00796653|183220812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.922|STANDARD_ERROR_OF_MEAN|0.15||0.6404||95.0|0.67|1.267|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.267|0.670|0.6404
91662713|NCT00796653|183220813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.685|STANDARD_ERROR_OF_MEAN|0.249||0.2942||95.0|0.336|1.399|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.399|0.336|0.2942
91625871|NCT05109702|183144349|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.148||0.287|TWO_SIDED|95.0|-0.133|0.449|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.449|-0.133|0.287
91662714|NCT00796653|183220813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947|STANDARD_ERROR_OF_MEAN|0.316||0.8594||95.0|0.493|1.82|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.820|0.493|0.8594
91662715|NCT00796653|183220813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|STANDARD_ERROR_OF_MEAN|0.281||0.5466||95.0|0.405|1.593|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.593|0.405|0.5466
91662716|NCT00796653|183220814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807|STANDARD_ERROR_OF_MEAN|0.146||0.2494||95.0|0.566|1.15|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.150|0.566|0.2494
91662717|NCT00796653|183220814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791|STANDARD_ERROR_OF_MEAN|0.143||0.2006||95.0|0.555|1.126|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.126|0.555|0.2006
91662718|NCT00796653|183220814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903|STANDARD_ERROR_OF_MEAN|0.16||0.5795||95.0|0.637|1.279|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.279|0.637|0.5795
91662719|NCT00796653|183220815|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.785|STANDARD_ERROR_OF_MEAN|0.1342||0.1571||95.0|0.5613|1.0979|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0979|0.5613|0.1571
91662720|NCT00796653|183220815|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8631|STANDARD_ERROR_OF_MEAN|0.1451||0.3814||95.0|0.6205|1.2005|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2005|0.6205|0.3814
91662721|NCT00796653|183220815|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0631|STANDARD_ERROR_OF_MEAN|0.1748||0.7098||95.0|0.7699|1.468|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.4680|0.7699|0.7098
91662722|NCT00796653|183220816|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7925|STANDARD_ERROR_OF_MEAN|0.2952||0.5326||95.0|0.3814|1.6464|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6464|0.3814|0.5326
91662723|NCT00796653|183220816|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0078|STANDARD_ERROR_OF_MEAN|0.356||0.9824||95.0|0.5038|2.016|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0160|0.5038|0.9824
91662724|NCT00796653|183220816|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0403|STANDARD_ERROR_OF_MEAN|0.3681||0.9112||95.0|0.5194|2.0832|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||2.0832|0.5194|0.9112
91662725|NCT00796653|183220817|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.744|STANDARD_ERROR_OF_MEAN|0.1389||0.1136||95.0|0.5158|1.0733|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0733|0.5158|0.1136
91713972|NCT04556760|183319550|OTHER||Mean Difference (Final Values)|26.4529||||0.432||95.0|-44.9414|97.8471|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||97.8471|-44.9414|0.432
91713973|NCT04556760|183319550|OTHER||Mean Difference (Final Values)|-24.0243||||0.282||95.0|-74.0731|26.0245|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||26.0245|-74.0731|0.282
91662726|NCT00796653|183220817|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7842|STANDARD_ERROR_OF_MEAN|0.1449||0.1887||95.0|0.5456|1.1271|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1271|0.5456|0.1887
91662727|NCT00796653|183220817|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.9761|STANDARD_ERROR_OF_MEAN|0.1747||0.8925||95.0|0.6869|1.387|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.3870|0.6869|0.8925
91662728|NCT00796653|183220820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027|TWO_SIDED|95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
91713974|NCT04556760|183319551|OTHER||Mean Difference (Final Values)|-0.6023||||0.531|TWO_SIDED|95.0|-2.5463|1.3416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1.3416|-2.5463|0.531
91713975|NCT04556760|183319551|OTHER||Mean Difference (Final Values)|0.4621||||0.682|TWO_SIDED|95.0|-2.0933|3.0176|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||3.0176|-2.0933|0.682
91713976|NCT04556760|183319552|OTHER||Mean Difference (Final Values)|0.0679||||0.526||95.0|-0.152|0.2866|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.2866|-0.1520|0.526
91713977|NCT04556760|183319552|OTHER||Mean Difference (Final Values)|0.0882||||0.569||95.0|-0.2653|0.4416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg||0.4416|-0.2653|0.569
91713978|NCT04556760|183319552|OTHER||Mean Difference (Final Values)|0.1257||||0.166|TWO_SIDED|95.0|-0.0677|0.3191|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3191|-0.0677|0.166
91713979|NCT04556760|183319553|OTHER||Mean Difference (Final Values)|0.01||||0.226|TWO_SIDED|95.0|-0.0072|0.0271|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0271|-0.0072|0.226
91482050|NCT02043379|182838095|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||post-operative day 3 (72 hours) IgG level||||<0.01
91482051|NCT02043379|182838095|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||post-operative day 5 (120 hours) IgG level||||<0.01
91525235|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.001|TWO_SIDED|95.0|0.34|0.78|||Regression, Logistic|||||0.78|0.34|<0.001
91625872|NCT05109702|183144349|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.148||0.26|TWO_SIDED|95.0|-0.124|0.458|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.458|-0.124|0.260
91625873|NCT05109702|183144349|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.987|TWO_SIDED|95.0|-0.296|0.291|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.291|-0.296|0.987
91662729|NCT00796653|183220820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203|TWO_SIDED|95.0|0.082|0.967|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
91625874|NCT05109702|183144349|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.151||0.143|TWO_SIDED|95.0|-0.075|0.519|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.519|-0.075|0.143
91625875|NCT05109702|183144350|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.151||-0.198|TWO_SIDED|95.0|-0.102|0.49|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.490|-0.102|-0.198
91625876|NCT05109702|183144350|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.151||0.076|TWO_SIDED|95.0|-0.028|0.564|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.564|-0.028|0.076
91625877|NCT05109702|183144350|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.152||0.656|TWO_SIDED|95.0|-0.231|0.367|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.367|-0.231|0.656
91625878|NCT05109702|183144350|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.154||0.324|TWO_SIDED|95.0|-0.15|0.454|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.454|-0.150|0.324
91662730|NCT00796653|183220820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166|TWO_SIDED|95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
91662731|NCT00835692|183220825|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Mean x 100|98.4||||||90.0|91.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|91.5|
91482052|NCT02043379|182838096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.6||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.60
91482053|NCT02043379|182838096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.06
91482054|NCT02043379|182838096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.06
91482055|NCT02043379|182838096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.33||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative||||0.33
91525236|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.57|||<|0.001|TWO_SIDED|95.0|0.38|0.76|||Regression, Logistic|||||0.76|0.38|<0.001
91625879|NCT05109702|183144351|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.146||0.477|TWO_SIDED|95.0|-0.182|0.39|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.390|-0.182|0.477
91625880|NCT05109702|183144351|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.146||0.033|TWO_SIDED|95.0|0.026|0.598|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.598|0.026|0.033
91625881|NCT05109702|183144351|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.147||0.374|TWO_SIDED|95.0|-0.158|0.42|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.420|-0.158|0.374
91625882|NCT05109702|183144351|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.149||0.114|TWO_SIDED|95.0|-0.056|0.529|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.529|-0.056|0.114
91625883|NCT05109702|183144352|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.329||0.598|TWO_SIDED|95.0|-0.822|0.475|||t-test, 2 sided|||Immediately Upon Instillation at Week 1||0.475|-0.822|0.598
91625884|NCT05109702|183144352|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.268||0.343|TWO_SIDED|95.0|-0.783|0.273|||t-test, 2 sided|||1 Minute Post Instillation at Week 1||0.273|-0.783|0.343
91625885|NCT05109702|183144352|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.359|TWO_SIDED|95.0|-0.721|0.262|||t-test, 2 sided|||2 Minutes Post Instillation at Week 1||0.262|-0.721|0.359
91625886|NCT03812588|183144355|SUPERIORITY||Slope|7.9|STANDARD_ERROR_OF_MEAN|7.261||0.292|TWO_SIDED|||||Linear regression model of condition in predicting change in HRSD-24. P-value and coefficient are Medication:Track. Medication (Escitalopram or Placebo) with Track (RFM or CFM) as co-variates. The threshold for statistical significance was p\>0.05.|Regression, Linear|||||||0.292
91625887|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0856|TWO_SIDED|95.0|0.69|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.69|0.0856
91625888|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.8546|TWO_SIDED|95.0|0.84|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.84|0.8546
91625889|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.73||||0.0012|TWO_SIDED|95.0|0.62|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.62|0.0012
91662732|NCT00835692|183220826|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.6|97.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.6|89.6|
91662733|NCT00835692|183220827|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.5|97.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.7|89.5|
91625890|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.8414|TWO_SIDED|95.0|0.87|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.87|0.8414
91625891|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2412|TWO_SIDED|95.0|0.64|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.64|0.2412
91662734|NCT04970810|183220873|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||||||0.8
91791988|NCT04902326|183461794|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
91662735|NCT04970810|183220873|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.3
91662736|NCT04970810|183220873|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
91662737|NCT04970810|183220874|SUPERIORITY|||||||0.2|||||||Chi-squared|||Documented goals at baseline for all three arms.||||0.2
91662738|NCT04970810|183220874|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Documented goals after Baseline in all three arms.||||<0.001
91662739|NCT04970810|183220875|SUPERIORITY|||||||0.7|||||||Chi-squared|||Initial goal at baseline.||||0.7
91525237|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|-0.23||||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Regression, Logistic|||||-0.02|-0.44|0.029
91482056|NCT02043379|182838096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.05||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative||||0.05
91482057|NCT02043379|182838096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.83||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hours post-operative||||0.83
91482058|NCT02043379|182838097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour levels||||0.27
91482059|NCT02043379|182838097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.34
91482060|NCT02043379|182838097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.14
91482061|NCT02043379|182838097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.13||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.13
91525238|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.02||||0.898|TWO_SIDED|95.0|-0.22|0.25|||Regression, Logistic|||||0.25|-0.22|0.898
91625892|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.4548|TWO_SIDED|95.0|0.88|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.88|0.4548
91625893|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.69||||0.0093|TWO_SIDED|95.0|0.53|0.88||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.88|0.53|0.0093
91625894|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.8414|TWO_SIDED|95.0|0.86|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.86|0.8414
91625895|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.1749|TWO_SIDED|95.0|0.75|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.75|0.1749
91625896|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.3121|TWO_SIDED|95.0|0.96|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.96|0.3121
91482062|NCT02043379|182838097|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.02
91482063|NCT02043379|182838098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
91482064|NCT02043379|182838099|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4
91482065|NCT02043379|182838100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.09||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-48 hours post-CPB||||0.09
91482066|NCT02043379|182838100|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-24 hours post CPB||||0.52
91482067|NCT02043379|182838101|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.72||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.72
91625897|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.1351|TWO_SIDED|95.0|0.78|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.78|0.1351
91662740|NCT04970810|183220875|SUPERIORITY|||||||0.6|||||||Chi-squared|||Modified goal after Month 1 call with nurse.||||0.6
91482068|NCT02043379|182838102|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.63||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.63
91482069|NCT02043379|182838103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.41||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.41
91482070|NCT02043379|182838103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.34
91482071|NCT02043379|182838103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.47
91525239|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.0||||0.968|TWO_SIDED|95.0|-0.24|0.23|||Regression, Logistic|||||0.23|-0.24|0.968
91525240|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||Regression, Logistic|||||0.42|0.02|0.033
91482072|NCT02043379|182838103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.42
91662741|NCT04970810|183220876|SUPERIORITY|||||||0.2|||||||Chi-squared|||Achieved goal at baseline across three arms.||||0.2
91662742|NCT04970810|183220876|SUPERIORITY|||||||0.9|||||||Chi-squared|||Achieved goal at 12 months across all three arms.||||0.9
91662743|NCT04970810|183220877|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
91662744|NCT04970810|183220877|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
91662745|NCT04970810|183220877|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
91662746|NCT01492439|183220904|SUPERIORITY_OR_OTHER|||||||0.029||||||This applies to Semester 1.|t-test, 1 sided|||||||0.029
91662747|NCT01492439|183220904|SUPERIORITY_OR_OTHER|||||||0.225||||||This applies to semester 2.|t-test, 1 sided|||||||0.225
91662748|NCT01492439|183220905|SUPERIORITY_OR_OTHER|||||||0.247||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.247
91482073|NCT02043379|182838103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.82
91482074|NCT02043379|182838103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.44||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.44
91482075|NCT02043379|182838104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.28||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.28
91662749|NCT01492439|183220905|SUPERIORITY_OR_OTHER|||||||0.747||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.747
91662750|NCT01492439|183220905|SUPERIORITY_OR_OTHER|||||||0.582||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.582
91662751|NCT01492439|183220906|SUPERIORITY_OR_OTHER|||||||0|||||||ANCOVA|||||||0.000
91662752|NCT01492439|183220907|SUPERIORITY_OR_OTHER|||||||0.95||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.950
91482076|NCT02043379|182838104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.37
91662753|NCT01492439|183220907|SUPERIORITY_OR_OTHER|||||||0.027||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.027
91662754|NCT01492439|183220907|SUPERIORITY_OR_OTHER|||||||0.639||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.639
91662755|NCT01492439|183220908|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|||||||0.008
91662756|NCT01492439|183220909|SUPERIORITY_OR_OTHER|||||||0.314||||||This applies to Trial 1 on the CVLT.|ANCOVA|||||||0.314
91662757|NCT01492439|183220909|SUPERIORITY_OR_OTHER|||||||0.242||||||This applies to the total score of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.242
91662758|NCT01492439|183220909|SUPERIORITY_OR_OTHER|||||||0.669||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.669
91662759|NCT01492439|183220910|SUPERIORITY_OR_OTHER|||||||0.139||||||This applies to the 'trial 1' subtest of the CVLT.|ANCOVA|||||||0.139
91662760|NCT01492439|183220910|SUPERIORITY_OR_OTHER|||||||0.269||||||This applies to the total of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.269
91662761|NCT01492439|183220910|SUPERIORITY_OR_OTHER|||||||0.666||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.666
91662762|NCT01492439|183220911|SUPERIORITY_OR_OTHER|||||||0.391|||||||ANCOVA|||||||0.391
91662763|NCT01492439|183220912|SUPERIORITY_OR_OTHER|||||||0.958|||||||ANCOVA|||||||0.958
91662764|NCT01492439|183220913|SUPERIORITY_OR_OTHER|||||||0.754||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.754
91662765|NCT01492439|183220913|SUPERIORITY_OR_OTHER|||||||0.518||||||This applies to the 'backward' sequence of the Digit Span Test.|ANCOVA|||||||0.518
91662766|NCT01492439|183220913|SUPERIORITY_OR_OTHER|||||||0.531||||||This applies to the total score (forward+backwards) on the Digit Span Test.|ANCOVA|||||||0.531
91662767|NCT01492439|183220914|SUPERIORITY_OR_OTHER|||||||0.802||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.802
91662768|NCT01492439|183220914|SUPERIORITY_OR_OTHER|||||||0.091||||||This applies to the 'backwards' sequence of the Digit Span Test.|ANCOVA|||||||0.091
91662769|NCT01492439|183220914|SUPERIORITY_OR_OTHER|||||||0.171||||||This applies to the total score (forward + backwards) on the Digit Span Test.|ANCOVA|||||||0.171
91662770|NCT01492439|183220915|SUPERIORITY_OR_OTHER|||||||0.267|||||||ANCOVA|||||||0.267
91662771|NCT01492439|183220916|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANCOVA|||||||0.527
91662772|NCT01492439|183220917|SUPERIORITY_OR_OTHER|||||||0.852||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.852
91662773|NCT01492439|183220917|SUPERIORITY_OR_OTHER|||||||0.637||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.637
91662774|NCT01492439|183220918|SUPERIORITY_OR_OTHER|||||||0.612||||||This applies to the total number of correct categories on the WCST|ANCOVA|||||||0.612
91662775|NCT01492439|183220919|SUPERIORITY_OR_OTHER|||||||0.156||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.156
91662776|NCT01492439|183220919|SUPERIORITY_OR_OTHER|||||||0.926||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.926
91662777|NCT01492439|183220920|SUPERIORITY_OR_OTHER|||||||0.843|||||||ANCOVA|||This applies to the total number of categories on the WCST.||||0.843
91662778|NCT01492439|183220921|SUPERIORITY_OR_OTHER|||||||0.129||||||This applies to the total number of errors made on the DVT.|ANCOVA|||||||0.129
91662779|NCT01492439|183220922|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.004
91662780|NCT01492439|183220923|SUPERIORITY_OR_OTHER|||||||0.853|||||||ANCOVA|This applies to the total number of errors on the DVT.||||||0.853
91662781|NCT01492439|183220924|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.468
91662782|NCT04618211|183220948|SUPERIORITY||Least squares mean difference|-16.75|STANDARD_ERROR_OF_MEAN|2.423|<|0.0001|TWO_SIDED|95.0|-21.52|-11.97||Nominal p-value|Mixed model repeated measures|||||-11.97|-21.52|< 0.0001
91625898|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.8414|TWO_SIDED|95.0|0.93|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.93|0.8414
91625899|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2158|TWO_SIDED|95.0|0.67|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.67|0.2158
91625900|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.3279|TWO_SIDED|95.0|0.71|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.71|0.3279
91625901|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2472|TWO_SIDED|95.0|0.72|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.72|0.2472
91625902|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.8414|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.8414
91625903|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6193|TWO_SIDED|95.0|0.81|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.81|0.6193
91625904|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
91625905|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0191|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0191
91625906|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.8414|TWO_SIDED|95.0|0.97|1.33||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.33|0.97|0.8414
91625907|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.76|0.2412
91625908|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.99|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.99|0.3121
91625909|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.8||||0.0135|TWO_SIDED|95.0|0.68|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.68|0.0135
91662783|NCT04618211|183220948|SUPERIORITY||Least squares mean difference|-15.02|STANDARD_ERROR_OF_MEAN|2.64|<|0.0001|TWO_SIDED|95.0|-20.22|-9.81|||Mixed model repeated measures|||||-9.81|-20.22|< 0.0001
91662784|NCT04618211|183220948|SUPERIORITY||Least squares mean difference|-16.28|STANDARD_ERROR_OF_MEAN|2.531|<|0.0001|TWO_SIDED|95.0|-21.27|-11.29|||Mixed model repeated measures|||||-11.29|-21.27|< 0.0001
91662785|NCT04618211|183220949|SUPERIORITY||Hazard Ratio (HR)|3.81|||<|0.0001|TWO_SIDED|95.0|2.01|7.2||Nominal p-value|Marginal Cox Proportional Hazards Model|||||7.2|2.01|< 0.0001
91482077|NCT02043379|182838104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.42
91482078|NCT02043379|182838104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.31||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.31
91482079|NCT02043379|182838104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.38
91482080|NCT02043379|182838104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.4
91662786|NCT04618211|183220949|SUPERIORITY||Hazard Ratio (HR)|3.08||||0.0021|TWO_SIDED|95.0|1.5|6.3|||Marginal Cox Proportional Hazards Model|||||6.3|1.5|0.0021
91791989|NCT04902326|183461795|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
91482081|NCT02043379|182838105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
91625910|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.87|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.87|0.8414
91662787|NCT04618211|183220949|SUPERIORITY||Hazard Ratio (HR)|3.61|||<|0.0001|TWO_SIDED|95.0|2.1|6.19|||Marginal Cox Proportional Hazards Model|||||6.19|2.1|< 0.0001
91662788|NCT04618211|183220950|SUPERIORITY||Hazard Ratio (HR)|5.09|||<|0.0001|TWO_SIDED|95.0|2.81|9.22||Nominal p-value|Cox Proportional Hazards Model|||||9.22|2.81|< 0.0001
91662789|NCT04618211|183220950|SUPERIORITY||Hazard Ratio (HR)|2.25||||0.0127|TWO_SIDED|95.0|1.19|4.27|||Marginal Cox Proportional Hazards Model|||||4.27|1.19|0.0127
91662790|NCT04618211|183220950|SUPERIORITY||Hazard Ratio (HR)|2.65||||0.0001|TWO_SIDED|95.0|1.61|4.38|||Marginal Cox Proportional Hazards Model|||||4.38|1.61|0.0001
91482082|NCT02043379|182838105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.12||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.12
91482083|NCT02043379|182838105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.51||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.51
91482084|NCT02043379|182838105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.27
91482085|NCT02043379|182838105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.88||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.88
91625911|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.1749|TWO_SIDED|95.0|0.66|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.66|0.1749
91625912|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.93|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|0.93|0.3121
91482086|NCT02043379|182838105|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
91625913|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.7||||0.0038|TWO_SIDED|95.0|0.57|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.57|0.0038
91625914|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.84|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.84|0.8414
91625915|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
91482087|NCT02043379|182838106|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.35
91482088|NCT02043379|182838106|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.39||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.39
91525241|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.19||||0.099|TWO_SIDED|95.0|-0.04|0.41|||Regression, Logistic|||||0.41|-0.04|0.099
91625916|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.2||||0.2053|TWO_SIDED|95.0|1.02|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|1.02|0.2053
91662791|NCT04618211|183220951|SUPERIORITY||Hazard Ratio (HR)|4.55|||<|0.0001|TWO_SIDED|95.0|2.41|8.59||Nominal p-value|Marginal Cox Proportional Hazards Model|||||8.59|2.41|< 0.0001
91662792|NCT04618211|183220951|SUPERIORITY||Hazard Ratio (HR)|3.65||||0.0003|TWO_SIDED|95.0|1.8|7.38|||Marginal Cox Proportional Hazards Model|||||7.38|1.8|0.0003
91662793|NCT04618211|183220951|SUPERIORITY||Hazard Ratio (HR)|3.87|||<|0.0001|TWO_SIDED|95.0|2.26|6.63|||Marginal Cox Proportional Hazards Model|||||6.63|2.26|< 0.0001
91662794|NCT04618211|183220952|SUPERIORITY||Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|-1.11|-0.46||Nominal p-value|Mixed model repeated measures|||||-0.46|-1.11|< 0.0001
91662795|NCT04618211|183220952|SUPERIORITY||Least squares mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.178||0.0008|TWO_SIDED|95.0|-0.97|-0.26|||Mixed model repeated measures|||||-0.26|-0.97|0.0008
91662796|NCT04618211|183220952|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.174||0.0291|TWO_SIDED|95.0|-0.73|-0.04|||Mixed model repeated measures|||||-0.04|-0.73|0.0291
91662797|NCT04618211|183220953|SUPERIORITY||Least squares mean difference|64.13|STANDARD_ERROR_OF_MEAN|12.016|<|0.0001|TWO_SIDED|95.0|40.35|87.91||Nominal p-value|Mixed model repeated measures|||||87.91|40.35|< 0.0001
91482089|NCT02043379|182838106|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.58||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.58
91482090|NCT02043379|182838106|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.36||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.36
91482091|NCT02043379|182838106|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.61||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.61
91482092|NCT02043379|182838106|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
91482093|NCT02043379|182838107|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
91625917|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0241|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0241
91625918|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.8414
91482094|NCT02043379|182838107|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.02
91625919|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0732|TWO_SIDED|95.0|0.69|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.69|0.0732
91625920|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.609|TWO_SIDED|95.0|0.82|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.82|0.6090
91662798|NCT04618211|183220953|SUPERIORITY||Least squares mean difference|62.69|STANDARD_ERROR_OF_MEAN|13.128|<|0.0001|TWO_SIDED|95.0|36.71|88.67|||Mixed model repeated measures|||||88.67|36.71|< 0.0001
91482095|NCT02043379|182838107|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.34
91482096|NCT02043379|182838107|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.35
91482097|NCT02043379|182838107|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.67||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.67
91482098|NCT02043379|182838107|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.47
91482099|NCT02043379|182838108|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.46||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.46
91625921|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.56|0.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.76|0.56|<0.0001
91625922|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.8414|TWO_SIDED|95.0|0.82|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.82|0.8414
91625923|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7828|TWO_SIDED|95.0|0.82|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.82|0.7828
91662799|NCT04618211|183220953|SUPERIORITY||Least squares mean difference|71.06|STANDARD_ERROR_OF_MEAN|12.613|<|0.0001|TWO_SIDED|95.0|46.09|96.03|||Mixed model repeated measures|||||96.03|46.09|< 0.0001
91482100|NCT02043379|182838108|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.04
91482101|NCT02043379|182838108|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.14
91482102|NCT02043379|182838108|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.82
91662800|NCT00466167|183220976|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|4.9|STANDARD_ERROR_OF_MEAN|1.3||0.0001|TWO_SIDED|95.0|2.4|7.4|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.4|2.4|0.0001
91482103|NCT02043379|182838108|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.9||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.9
91625924|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.21||||0.2053|TWO_SIDED|95.0|1.02|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|1.02|0.2053
91791990|NCT04902326|183461796|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||Compare the mean months engaged (with DPP or metformin) of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||<0.0001
91791991|NCT00461331|183461801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|96.4|STANDARD_DEVIATION|8.5||0.52||95.0|87.9|100.0|||Regression, Linear|7 patients underwent early termination of either one or both of their test period due to loss of glycemic control||Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.||100.0|87.9|0.52
91791992|NCT00461331|183461802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.35|STANDARD_DEVIATION|4.165||0.15||95.0|0.97|9.23|||Regression, Linear||This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.23|0.97|0.15
91791993|NCT00461331|183461803|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7|STANDARD_DEVIATION|2.35||0.55||95.0|4.4|9.4|||Regression, Linear||This was for test period 1 between days 3 and 5 after the last pump infusion line change.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.4|4.4|0.55
91791994|NCT01155479|183461804|SUPERIORITY_OR_OTHER||Difference in Estimated Means|2.6||||0.0033|TWO_SIDED|95.0|0.86|4.3|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||4.30|0.86|0.0033
91791995|NCT01155479|183461804|SUPERIORITY_OR_OTHER||Difference in Estimated Means|1.3||||0.1382|TWO_SIDED|95.0|-0.41|2.94|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||2.94|-0.41|0.1382
91791996|NCT01155479|183461804|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.4||||0.6378|TWO_SIDED|95.0|-1.29|2.11|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||2.11|-1.29|0.6378
91791997|NCT01155479|183461804|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.3||||0.6923|TWO_SIDED|95.0|-1.35|2.03|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||2.03|-1.35|0.6923
91791998|NCT01155479|183461805|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-9.7||||0.0785|TWO_SIDED|95.0|-21.0|1.82||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.82|-21.0|0.0785
91791999|NCT01155479|183461805|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-6.3||||0.2735|TWO_SIDED|95.0|-17.6|5.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||5.05|-17.6|0.2735
91792000|NCT01155479|183461805|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-3.7||||0.4823|TWO_SIDED|95.0|-15.2|7.99||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||7.99|-15.2|0.4823
91792001|NCT01155479|183461805|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-2.3||||0.6827|TWO_SIDED|95.0|-13.9|9.24||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Rasagiline (Part 1) vs Placebo (Part 1)||9.24|-13.9|0.6827
91792002|NCT01155479|183461806|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.7||||0.0235|TWO_SIDED|95.0|0.09|1.27|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.27|0.09|0.0235
91792003|NCT01155479|183461806|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.5||||0.1093|TWO_SIDED|95.0|-0.11|1.04|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||1.04|-0.11|0.1093
91792004|NCT01155479|183461806|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.5756|TWO_SIDED|95.0|-0.42|0.75|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||0.75|-0.42|0.5756
91625925|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0093|TWO_SIDED|95.0|0.65|0.92||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.92|0.65|0.0093
91792005|NCT01155479|183461806|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.6657|TWO_SIDED|95.0|-0.45|0.7|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||0.70|-0.45|0.6657
91792006|NCT01857310|183461811|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|2.8|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.7|
91482104|NCT02043379|182838108|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.78||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.78
91625926|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.93|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.93|0.8414
91625927|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2412|TWO_SIDED|95.0|0.73|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.73|0.2412
91662801|NCT00466167|183220976|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|6.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|4.2|9.1|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||9.1|4.2|<.0001
91662802|NCT00466167|183220977|SUPERIORITY_OR_OTHER||Adjusted mean difference from Placebo|4.5|STANDARD_ERROR_OF_MEAN|1.8||0.0122|TWO_SIDED|95.0|1.0|7.9|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.9|1.0|0.0122
91662803|NCT00466167|183220977|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|7.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|3.7|10.5|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||10.5|3.7|<.0001
91662804|NCT03930732|183220993|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level.|Risk Difference (RD)|-0.324||||0.0005|TWO_SIDED|95.0|-0.508|-0.14|||Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), inhaled corticosteroid (ICS) dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.140|-0.508|0.0005
91662805|NCT03930732|183220994|SUPERIORITY||Least Square (LS) Mean Difference|0.083|||<|0.0001|TWO_SIDED|95.0|0.042|0.125||Threshold for significance at 0.049 level.|MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.125|0.042|<0.0001
91662806|NCT03930732|183220995|SUPERIORITY||LS Mean Difference|0.083||||0.0003|TWO_SIDED|95.0|0.038|0.128||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BDFEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.128|0.038|0.0003
91662807|NCT03930732|183220996|SUPERIORITY||LS Mean Difference|0.124||||0.0022|TWO_SIDED|95.0|0.045|0.203||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.203|0.045|0.0022
91662808|NCT03930732|183220997|SUPERIORITY||LS Mean Difference|0.127||||0.0034|TWO_SIDED|95.0|0.042|0.212||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.212|0.042|0.0034
91662809|NCT03930732|183220998|SUPERIORITY||LS Mean Difference|-3.363||||0.0017|TWO_SIDED|95.0|-5.459|-1.266||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.266|-5.459|0.0017
91662810|NCT03930732|183220999|SUPERIORITY||Odds Ratio (OR)|1.439||||0.0089|TWO_SIDED|95.0|1.096|1.89||Threshold for significance at 0.049 level.|Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.890|1.096|0.0089
91713980|NCT04556760|183319553|OTHER||Mean Difference (Final Values)|0.0033||||0.619||95.0|-0.0128|0.0195|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0195|-0.0128|0.619
91792007|NCT01857310|183461811|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||1.09|0.88|
91625928|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.3121|TWO_SIDED|95.0|0.95|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.95|0.3121
91625929|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0135|TWO_SIDED|95.0|0.64|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.64|0.0135
91662811|NCT03930732|183221000|SUPERIORITY||LS Mean Difference|-1.137||||0.0012|TWO_SIDED|95.0|-1.823|-0.45||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in E-RS: COPD RS-Total Score to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline E-RS: COPD RS-Total Score, and baseline E-RS: COPD RS-Total Score-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.450|-1.823|0.0012
91662812|NCT03930732|183221001|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|Risk Difference (RD)|-0.418||||0.0052|TWO_SIDED|95.0|-0.728|-0.109||Threshold for significance at 0.049 level.|Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.109|-0.728|0.0052
91662813|NCT04708028|183221010|SUPERIORITY|||||||0.379|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.379
91662814|NCT04708028|183221010|SUPERIORITY|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.646
91662815|NCT04708028|183221010|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.219
91625930|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.92|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.92|0.8414
91625931|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.79|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.79|0.2412
91625932|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.6652|TWO_SIDED|95.0|0.91|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.91|0.6652
91625933|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.0275|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.0275
91625934|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.8414|TWO_SIDED|95.0|0.93|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.93|0.8414
91625935|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
91625936|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
91625937|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.0387|TWO_SIDED|95.0|0.72|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.72|0.0387
91625938|NCT01392378|183144359|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.8414
91625939|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.82|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.82|0.9350
91625940|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.7918|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.7918
91625941|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.6922|TWO_SIDED|95.0|0.8|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.80|0.6922
91482105|NCT02043379|182838109|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour level||||0.37
91482106|NCT02043379|182838109|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.47
91482107|NCT02043379|182838109|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.47
91625942|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.9765|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.9765
91625943|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6915|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6915
91625944|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.94|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.94|0.7918
91625945|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.4389|TWO_SIDED|95.0|0.75|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.75|0.4389
91625946|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.85|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.85|0.9765
91625947|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.87|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.87|0.9350
91625948|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.7918|TWO_SIDED|95.0|0.9|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.90|0.7918
91625949|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.943|TWO_SIDED|95.0|0.88|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.88|0.9430
91625950|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.9765|TWO_SIDED|95.0|0.85|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.85|0.9765
91625951|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.5167|TWO_SIDED|95.0|0.74|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.74|0.5167
91662816|NCT04708028|183221010|SUPERIORITY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.223
91662817|NCT04708028|183221011|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.410
91662818|NCT04708028|183221011|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.127
91662819|NCT04708028|183221011|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.268
91662820|NCT04708028|183221011|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.353
91662821|NCT04128761|183221033|OTHER|Mechanistic study examining the influence of scarcity narratives on delay discounting||||||0.6||||||The reported p-value is for the Scarcity and Session interaction.|ANOVA|||The effects of narrative type on delay discounting rates were evaluated using a two-way (Scarcity vs. Session) repeated-measures ANOVA.||||.60
91662822|NCT04128761|183221034|OTHER|Mechanistic study examining the influence of scarcity narratives on intensity of demand (i.e., consumption at $0)||||||0.54||||||The p-value reported is for the Scarcity and Session interaction term of the two-way repeated-measures ANOVA.|ANOVA|||The effects of narrative type on intensity of alcohol demand were evaluated using a two-way (Scarcity vs. Session) repeated-measures ANOVA.||||.54
91662823|NCT04128761|183221035|OTHER|Mechanistic study examining the influence of scarcity narratives on alcohol craving||||||0.88||||||The p-value reported is for the Scarcity and Session interaction term of the two-way repeated-measures ANOVA.|ANOVA|||The effects of narrative type alcohol craving were evaluated using a two-way (Scarcity vs. Session) repeated-measures ANOVA.||||.88
91662824|NCT04128761|183221036|OTHER|Mechanistic study examining the influence of scarcity narratives on stress|||||<|0.001|||||||ANOVA|||The effects of narrative type on stress was evaluated using a one-way ANOVA.||||<.001
91662825|NCT03393208|183221041|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LeastSquare(LS) Mean%|99.76|||||TWO_SIDED|90.0|92.84|107.2||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||107.20|92.84|
91662826|NCT03393208|183221041|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.67||||||90.0|91.25|106.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||106.69|91.25|
91662827|NCT03393208|183221042|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|99.62||||||90.0|92.69|106.77||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||106.77|92.69|
91662828|NCT03393208|183221042|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.5||||||90.0|93.72|109.92||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||109.92|93.72|
91662829|NCT03393208|183221043|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.0|||||TWO_SIDED|90.0|-0.25|0.25||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||0.25|-0.25|
91662830|NCT03393208|183221043|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.25||||||90.0|-0.25|0.5||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||0.50|-0.25|
91662831|NCT03393208|183221045|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.26||||||90.0|94.33|108.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||108.69|94.33|
91662832|NCT03393208|183221045|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.17|||||TWO_SIDED|90.0|91.61|105.21||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||105.21|91.61|
91662833|NCT00207090|183221063|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.912|||||TWO_SIDED|90.0|0.751|1.106||||||Two-way analyses of variance were performed on log-transformed values of Cmax. The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||1.106|0.751|
91662834|NCT00207090|183221064|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.566|||||TWO_SIDED|90.0|0.482|0.664||||||Two-way analyses of variance were performed on log-transformed values of (AUC \[INF\]). The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||0.664|0.482|
91662835|NCT03480763|183221084|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.2||||0.043|TWO_SIDED|95.0|0.1|8.5|||Miettinen & Nurminen|||Injection site redness/erythema||8.5|0.1|0.043
91662836|NCT03480763|183221084|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|13.7|||<|0.001|TWO_SIDED|95.0|6.0|21.2|||Miettinen & Nurminen|||Injection site tenderness/pain||21.2|6.0|<0.001
91662837|NCT03480763|183221084|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.8||||0.077|TWO_SIDED|95.0|-0.5|10.2|||Miettinen & Nurminen|||Injection site swelling||10.2|-0.5|0.077
91662838|NCT03480763|183221085|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.6||||0.855|TWO_SIDED|95.0|-5.5|6.6|||Miettinen & Nurminen|||Injection site redness/erythema||6.6|-5.5|0.855
91662839|NCT03480763|183221085|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.5||||0.385||95.0|-4.4|11.3|||Miettinen & Nurminen|||Injection site tenderness/pain||11.3|-4.4|0.385
91662840|NCT03480763|183221085|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|2.0||||0.577|TWO_SIDED|95.0|-5.1|9.2|||Miettinen & Nurminen|||Injection site swelling||9.2|-5.1|0.577
91662841|NCT03480763|183221086|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.2||||0.523|TWO_SIDED|95.0|-2.5|4.9|||Miettinen & Nurminen|||Joint pain/arthralgia||4.9|-2.5|0.523
91662842|NCT03480763|183221086|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|9.7||||0.002|TWO_SIDED|95.0|3.7|15.6|||Miettinen & Nurminen|||Tiredness/fatigue||15.6|3.7|0.002
91662843|NCT03480763|183221086|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.4||||0.597|TWO_SIDED|95.0|-3.9|6.7|||Miettinen & Nurminen|||Headache||6.7|-3.9|0.597
91662844|NCT03480763|183221086|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|6.6||||0.016|TWO_SIDED|95.0|1.2|12.1|||Miettinen & Nurminen|||Muscle pain/myalgia||12.1|1.2|0.016
91662845|NCT03480763|183221087|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.961|TWO_SIDED|95.0|-4.4|4.7|||Miettinen & Nurminen|||Joint pain/arthralgia||4.7|-4.4|0.961
91662846|NCT03480763|183221087|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.0||||0.252|TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||Tiredness/fatigue||10.8|-2.8|0.252
91482108|NCT02043379|182838109|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.79
91662847|NCT03480763|183221087|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.5||||0.852|TWO_SIDED|95.0|-5.8|4.8|||Miettinen & Nurminen|||Headache||4.8|-5.8|0.852
91662848|NCT03480763|183221087|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.9||||0.125|TWO_SIDED|95.0|-1.4|11.2|||Miettinen & Nurminen|||Muscle pain/myalgia||11.2|-1.4|0.125
91662849|NCT03480763|183221088|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||Vaccine-related SAEs following V114 or Prevnar 13™||1.2|-1.2|
91662850|NCT03480763|183221089|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||Vaccine-related SAEs following PNEUMOVAX™23||1.3|-1.3|
91662851|NCT03480763|183221090|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.38|||||TWO_SIDED|95.0|1.1|1.74||||||Serotype 1 (Shared)||1.74|1.10|
91662852|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.9|1.29||||||Serotype 3 (Shared)||1.29|0.90|
91662853|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 4 (Shared)||1.32|0.85|
91662854|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.94|1.56||||||Serotype 5 (Shared)||1.56|0.94|
91662855|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43||||||Serotype 6A (Shared)||1.43|0.95|
91662856|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||Serotype 6B (Shared)||1.35|0.93|
91662857|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||Serotype 7F (Shared)||1.25|0.90|
91662858|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||Serotype 9V (Shared)||1.33|0.91|
91662859|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.27|||||TWO_SIDED|95.0|1.05|1.53||||||Serotype 14 (Shared)||1.53|1.05|
91662860|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||Serotype 18C (Shared)||1.34|0.95|
91662861|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.96|1.38||||||Serotype 19A (Shared)||1.38|0.96|
91662862|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2||||||Serotype 19F (Shared)||1.20|0.89|
91662863|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.01|1.61||||||Serotype 23F (Shared)||1.61|1.01|
91662864|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.63|||||TWO_SIDED|95.0|1.29|2.06||||||Serotype 22F (Unique to V114)||2.06|1.29|
91662865|NCT03480763|183221090|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Serotype 33F (Unique to V114)||1.17|0.77|
91662866|NCT03480763|183221091|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 1 (Shared)||1.07|0.79|
91662867|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3 (Shared)||1.16|0.87|
91482109|NCT02043379|182838109|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.04
91662868|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Serotype 4 (Shared)||1.02|0.74|
91662869|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.18||||||Serotype 5 (Shared)||1.18|0.84|
91662870|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 6A (Shared)||1.41|0.96|
91662871|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.4||||||Serotype 6B (Shared)||1.40|0.96|
91662872|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 7F (Shared)||1.16|0.85|
91662873|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.22||||||Serotype 9V (Shared)||1.22|0.89|
91662874|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|0.98|1.39||||||Serotype 14 (Shared)||1.39|0.98|
91662875|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.36||||||Serotype 18C (Shared)||1.36|1.00|
91482110|NCT02043379|182838110|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.43||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.43
91482111|NCT02043379|182838110|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.68||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||max||||0.68
91662876|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.29||||||Serotype 19A (Shared)||1.29|0.95|
91662877|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.93|1.27||||||Serotype 19F (Shared)||1.27|0.93|
91662878|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.96|1.35||||||Serotype 23F (Shared)||1.35|0.96|
91662879|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 22F (Unique to V114)||1.77|1.16|
91662880|NCT03480763|183221091|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||Serotype 33F (Unique to V114)||0.95|0.67|
91662881|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.94|1.58||||||Serotype 1 (Shared)||1.58|0.94|
91662882|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.3||||||Serotype 3 (Shared)||2.30|1.56|
91662883|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4 (Shared)||0.97|0.60|
91662884|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.81|1.4||||||Serotype 5 (Shared)||1.40|0.81|
91662885|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 6A (Shared)||1.53|0.92|
91482112|NCT02043379|182838111|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.87||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.87
91662886|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.64|||||TWO_SIDED|95.0|1.31|2.06||||||Serotype 6B (Shared)||2.06|1.31|
91662887|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.14||||||Serotype 7F (Shared)||1.14|0.80|
91713981|NCT04556760|183319553|OTHER||Mean Difference (Final Values)|0.0009||||0.917||95.0|-0.0189|0.0207|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0207|-0.0189|0.917
91482113|NCT02043379|182838111|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||24 hour post-operative max||||0.79
91662888|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.24||||||Serotype 9V (Shared)||1.24|0.83|
91662889|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.37||||||Serotype 14 (Shared)||1.37|0.87|
91662890|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.84||||||Serotype 18C (Shared)||1.84|1.20|
91662891|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.06|1.55||||||Serotype 19A (Shared)||1.55|1.06|
91662892|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.32||||||Serotype 19F (Shared)||1.32|0.92|
91662893|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.53|||||TWO_SIDED|95.0|1.18|2.0||||||Serotype 23F (Shared)||2.00|1.18|
91662894|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|34.86|||||TWO_SIDED|95.0|26.13|46.5||||||Serotype 22F (Unique to V114)||46.50|26.13|
91662895|NCT03480763|183221092|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|9.15|||||TWO_SIDED|95.0|7.48|11.2||||||Serotype 33F (Unique to V114)||11.20|7.48|
91662896|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.72|1.09||||||Serotype 1 (Shared)||1.09|0.72|
91662897|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.74|||||TWO_SIDED|95.0|1.46|2.07||||||Serotype 3 (Shared)||2.07|1.46|
91662898|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.99||||||Serotype 4 (Shared)||0.99|0.64|
91662899|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.3||||||Serotype 5 (Shared)||1.30|0.84|
91482114|NCT05985980|182838112|EQUIVALENCE|The null hypothesis is true that the ST/HR index (μV/bpm) ıs similar between the early and late follicular phases||||||0.521|||||||t-test, 2 sided|||||||0.521
91482115|NCT05985980|182838113|EQUIVALENCE|High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||||0.109|||||||ANOVA|||High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||0.109
91662900|NCT03480763|183221093|OTHER|GMCs, GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.77||||||Serotype 6A (Shared)||1.77|1.10|
91662901|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|1.28|2.1||||||Serotype 6B (Shared)||2.10|1.28|
91662902|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.74|1.13||||||Serotype 7F (Shared)||1.13|0.74|
91662903|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.41||||||Serotype 9V (Shared)||1.41|0.91|
91662904|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 14 (Shared)||1.38|0.87|
91662905|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.56|||||TWO_SIDED|95.0|1.27|1.92||||||Serotype 18C (Shared)||1.92|1.27|
91662906|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.39||||||Serotype 19A (Shared)||1.39|0.91|
91713982|NCT04556760|183319554|OTHER||Mean Difference (Final Values)|0.0007||||0.357|TWO_SIDED|95.0|-0.0008|0.0022|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0022|-0.0008|0.357
91713983|NCT04556760|183319554|OTHER||Mean Difference (Final Values)|0.0003||||0.676|TWO_SIDED|95.0|-0.0012|0.0017|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0017|-0.0012|0.676
91662907|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.92|1.41||||||Serotype 19F (Shared)||1.41|0.92|
91662908|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.61|||||TWO_SIDED|95.0|1.27|2.04||||||Serotype 23F (Shared)||2.04|1.27|
91525242|NCT04867785|182925761|SUPERIORITY||Risk Difference (RD)|0.2||||0.044|TWO_SIDED|95.0|0.01|0.39|||Regression, Logistic|||||0.39|0.01|0.044
91662909|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|16.54|||||TWO_SIDED|95.0|13.78|19.86||||||Serotype 22F (Unique to V114)||19.86|13.78|
91662910|NCT03480763|183221093|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|12.82|||||TWO_SIDED|95.0|10.82|15.19||||||Serotype 33F (Unique to V114)||15.19|10.82|
91662911|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 1 (Shared)||1.53|0.92|
91662912|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.29|1.9||||||Serotype 3 (Shared)||1.90|1.29|
91662913|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 4 (Shared)||0.90|0.57|
91662914|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.78|1.33||||||Serotype 5 (Shared)||1.33|0.78|
91662915|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.93|1.41||||||Serotype 6A (Shared)||1.41|0.93|
91662916|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 6B (Shared)||1.77|1.16|
91662917|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.11||||||Serotype 7F (Shared)||1.11|0.80|
91662918|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.81|1.18||||||Serotype 9V (Shared)||1.18|0.81|
91662919|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.9|1.36||||||Serotype 14 (Shared)||1.36|0.90|
91713984|NCT04556760|183319554|OTHER||Mean Difference (Final Values)|0.0012||||0.096||95.0|-0.0002|0.0026|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0026|-0.0002|0.096
91662920|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.05|1.55||||||Serotype 18C (Shared)||1.55|1.05|
91662921|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.31||||||Serotype 19A (Shared)||1.31|0.91|
91662922|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.91|1.29||||||Serotype 19F (Shared)||1.29|0.91|
91662923|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.37|||||TWO_SIDED|95.0|1.06|1.76||||||Serotype 23F (Shared)||1.76|1.06|
91713985|NCT04556760|183319555|OTHER||Mean Difference (Final Values)|-1.73||||0.646|TWO_SIDED|95.0|-9.4|5.95|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||5.95|-9.40|0.646
91662924|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.79|||||TWO_SIDED|95.0|9.44|17.34||||||Serotype 22F (Unique to V114)||17.34|9.44|
91662925|NCT03480763|183221098|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.24|||||TWO_SIDED|95.0|2.73|3.84||||||Serotype 33F (Unique to V114)||3.84|2.73|
91525243|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-2.12||||0.823|TWO_SIDED|95.0|-20.73|16.48|||Mixed Models Analysis|||||16.48|-20.73|0.823
91662926|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.65|0.92||||||Serotype 1 (Shared)||0.92|0.65|
91662927|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.24|1.63||||||Serotype 3 (Shared)||1.63|1.24|
91662928|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 4 (Shared)||0.91|0.64|
91662929|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.75|1.05||||||Serotype 5 (Shared)||1.05|0.75|
91662930|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.37|||||TWO_SIDED|95.0|1.12|1.67||||||Serotype 6A (Shared)||1.67|1.12|
91662931|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.81||||||Serotype 6B (Shared)||1.81|1.21|
91662932|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Serotype 7F (Shared)||1.02|0.72|
91662933|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.23||||||Serotype 9V (Shared)||1.23|0.88|
91662934|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||Serotype 14 (Shared)||1.26|0.88|
91662935|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 18C (Shared)||1.64|1.17|
91662936|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.33||||||Serotype 19A (Shared)||1.33|0.97|
91662937|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.96|1.32||||||Serotype 19F (Shared)||1.32|0.96|
91662938|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.35|||||TWO_SIDED|95.0|1.12|1.62||||||Serotype 23F (Shared)||1.62|1.12|
91713986|NCT04556760|183319555|OTHER||Mean Difference (Final Values)|-10.97||||0.11||95.0|-25.39|3.44|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3.44|-25.39|0.110
91713987|NCT04556760|183319555|OTHER||Mean Difference (Final Values)|-0.35||||0.932||95.0|-10.32|9.61|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9.61|-10.32|0.932
91713988|NCT04556760|183319556|OTHER||Mean Difference (Final Values)|7.6||||0.533|TWO_SIDED|95.0|-17.4|32.7|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||32.7|-17.4|0.533
91713989|NCT04556760|183319556|OTHER||Mean Difference (Final Values)|22.3||||0.311||95.0|-26.7|71.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||71.3|-26.7|0.311
91662939|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|6.2|||||TWO_SIDED|95.0|5.33|7.21||||||Serotype 22F (Unique to V114)||7.21|5.33|
91662940|NCT03480763|183221099|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|5.01|||||TWO_SIDED|95.0|4.38|5.73||||||Serotype 33F (Unique to V114)||5.73|4.38|
91662941|NCT00115063|183221134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91662942|NCT00115063|183221135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91662943|NCT00115063|183221136|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for systolic blood pressure mean.|t-test, 2 sided|||||||0.09
91662944|NCT00115063|183221136|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value for dystolic blood pressure mean.|t-test, 2 sided|||||||0.60
91662945|NCT00115063|183221137|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for LDL cholesterol|t-test, 2 sided|||||||0.73
91662946|NCT00115063|183221137|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for HDL cholesterol|t-test, 2 sided|||||||0.01
91662947|NCT00115063|183221137|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value for triglycerides|t-test, 2 sided|||||||0.42
91662948|NCT00115063|183221137|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for uric acid|t-test, 2 sided|||||||0.05
91713990|NCT04556760|183319556|OTHER||Mean Difference (Final Values)|31.0||||0.204||95.0|-21.9|83.9|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||83.9|-21.9|0.204
91662949|NCT00115063|183221138|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
91662950|NCT00115063|183221139|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
91662951|NCT00185458|183221144|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.128
91662952|NCT00185458|183221145|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.296
91662953|NCT00185458|183221147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662954|NCT00185458|183221149|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.027
91662955|NCT00185458|183221150|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662956|NCT00185458|183221151|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662957|NCT00185458|183221152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662958|NCT00185458|183221153|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.054
91662959|NCT00185458|183221154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662960|NCT00185458|183221155|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662961|NCT00185458|183221156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662962|NCT00185458|183221157|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662963|NCT00185458|183221158|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662964|NCT00185458|183221159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662965|NCT00185458|183221160|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.175
91662966|NCT00185458|183221161|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.062
91662967|NCT00185458|183221162|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
91662968|NCT00830024|183221163|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|98.75||||||90.0|93.35|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|93.35|
91713991|NCT04556760|183319566|OTHER||Mean Difference (Final Values)|-4.0066||||0.103|TWO_SIDED|95.0|-8.888|0.8748|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.8748|-8.8880|0.103
91482116|NCT05985980|182838114|EQUIVALENCE|ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||||0.111|||||||t-test, 2 sided|||ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||0.111
91625952|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.7918|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.7918
91625953|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.2514|TWO_SIDED|95.0|0.73|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.73|0.2514
91625954|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.84|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.84|0.9872
91625955|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2582|TWO_SIDED|95.0|0.73|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.73|0.2582
91625956|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.91|0.7918
91625957|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.2514
91625958|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
91625959|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.6915|TWO_SIDED|95.0|0.86|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.86|0.6915
91625960|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.93|1.38||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.38|0.93|0.7918
91625961|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6922
91662969|NCT00830024|183221164|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.94||||||90.0|91.76|100.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.3|91.76|
91662970|NCT00830024|183221165|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.89||||||90.0|91.67|100.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.31|91.67|
91662971|NCT02554890|183221166|OTHER||expon. back transformed from LS means|0.7143|||<|0.0001|TWO_SIDED|95.0|0.6315|0.808||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.8080|0.6315|<.0001
91662972|NCT02554890|183221170|OTHER||exponentially back transformed from LS m|0.8487||||0.0011|TWO_SIDED|95.0|0.7694|0.9361|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.9361|0.7694|0.0011
91662973|NCT02554890|183221171|OTHER||expon. back transformed from LS means|1.6487|||<|0.0001|TWO_SIDED|95.0|1.4559|1.8669|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.8669|1.4559|<.0001
91482117|NCT05985980|182838115|EQUIVALENCE|ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||||0.414|||||||t-test, 2 sided|||ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||0.414
91525244|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-19.6||||0.165|TWO_SIDED|95.0|-47.29|8.1|||Mixed Models Analysis|||||8.10|-47.29|0.165
91525245|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-33.3||||0.001|TWO_SIDED|95.0|-53.56|-13.04|||Mixed Models Analysis|||||-13.04|-53.56|0.001
91662974|NCT02554890|183221172|OTHER||expon. back transformed from LS means|1.4186|||<|0.0001|TWO_SIDED|95.0|1.3248|1.519|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5190|1.3248|<.0001
91662975|NCT02554890|183221173|OTHER||expon. back transformed from LS means|1.4745|||<|0.0001|TWO_SIDED|95.0|1.3752|1.581|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5810|1.3752|<.0001
91625962|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.9872|TWO_SIDED|95.0|0.83|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.83|0.9872
91625963|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.3609|TWO_SIDED|95.0|0.7|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.70|0.3609
91625964|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.7918|TWO_SIDED|95.0|0.89|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.89|0.7918
91625965|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.71|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.71|0.2514
91625966|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.9765|TWO_SIDED|95.0|0.86|1.26||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.26|0.86|0.9765
91625967|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.79|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.79|0.6304
91625968|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.91|0.7918
91662976|NCT02554890|183221174|OTHER||expon. back transformed from LS means|0.7133|||<|0.0001|TWO_SIDED|95.0|0.6171|0.8245||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/Valsartan vs. Enalapril|||0.8245|0.6171|<.0001
91625969|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2514|TWO_SIDED|95.0|0.75|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.75|0.2514
91625970|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
91625971|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.2582|TWO_SIDED|95.0|0.71|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.71|0.2582
91625972|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.9279|TWO_SIDED|95.0|0.84|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.84|0.9279
91625973|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.72|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.72|0.2514
91662977|NCT00834275|183221175|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|94.0|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|94|
91662978|NCT00834275|183221176|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|98.3|
91662979|NCT00834275|183221177|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|98.3|
91662980|NCT03649477|183221178|SUPERIORITY||Mean Difference (Net)|-1.202||||0.3493|TWO_SIDED|95.0|-3.729|1.324||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.324|-3.729|0.3493
91482118|NCT05985980|182838116|EQUIVALENCE|Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||||0.062|||||||t-test, 2 sided|||Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||0.062
91482119|NCT05985980|182838117|EQUIVALENCE|Estrogen levels increase at the late follicular phase.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91482120|NCT00282347|182838134|SUPERIORITY_OR_OTHER|||||||0.5538|TWO_SIDED||||||Stratified Wilcoxon-Rank Sum Test|||||||0.5538
91625974|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.9765|TWO_SIDED|95.0|0.76|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.76|0.9765
91625975|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.1424|TWO_SIDED|95.0|0.71|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.71|0.1424
91625976|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.7918|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.7918
91625977|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.73|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.73|0.2514
91625978|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.9765|TWO_SIDED|95.0|0.79|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.79|0.9765
91625979|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.6304|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.6304
91625980|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
91625981|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.6922
91625982|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.9765|TWO_SIDED|95.0|0.82|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.82|0.9765
91662981|NCT03649477|183221178|SUPERIORITY||Mean Difference (Net)|-3.136||||0.0162|TWO_SIDED|95.0|-5.685|-0.586||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.586|-5.685|0.0162
91662982|NCT03649477|183221179|SUPERIORITY||Mean Difference (Net)|-0.608||||0.6001|TWO_SIDED|95.0|-2.89|1.674||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.674|-2.890|0.6001
91482121|NCT02101112|182838143|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.054|||||TWO_SIDED|90.0|0.994|1.118||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.118|0.994|
91482122|NCT02101112|182838143|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.788|||||TWO_SIDED|90.0|0.741|0.839||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.839|0.741|
91662983|NCT03649477|183221179|SUPERIORITY||Mean Difference (Net)|-0.764||||0.5143|TWO_SIDED|95.0|-3.068|1.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.541|-3.068|0.5143
91662984|NCT03649477|183221180|SUPERIORITY||Mean Difference (Net)|0.183||||0.9144|TWO_SIDED|95.0|-3.175|3.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||3.541|-3.175|0.9144
91662985|NCT03649477|183221180|SUPERIORITY||Mean Difference (Net)|-3.812||||0.0266|TWO_SIDED|95.0|-7.177|-0.446||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.446|-7.177|0.0266
91662986|NCT03649477|183221181|SUPERIORITY||Mean Difference (Net)|-0.312||||0.1598|TWO_SIDED|95.0|-0.748|0.125||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.125|-0.748|0.1598
91482123|NCT02101112|182838144|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.076||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.076|0.981|
91482124|NCT02101112|182838144|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.835|||||TWO_SIDED|90.0|0.797|0.875||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.875|0.797|
91482125|NCT02101112|182838145|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.075||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.075|0.981|
91482126|NCT02101112|182838145|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.832|||||TWO_SIDED|90.0|0.794|0.871||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.871|0.794|
91525246|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-55.5|||<|0.001|TWO_SIDED|95.0|-69.77|-41.22|||Mixed Models Analysis|||||-41.22|-69.77|<0.001
91482127|NCT04340063|182838150|OTHER||Odds Ratio, log|0.4|||<|0.001|TWO_SIDED|95.0|0.25|0.55||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant was used and fixed effects were time (assessment order) and a time by group interaction (Treadmill or Movement Amplification). A binomial distribution was used for this model.||0.55|0.25|<0.001
91625983|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6572|TWO_SIDED|95.0|0.84|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.84|0.6572
91625984|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7918|TWO_SIDED|95.0|0.86|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.86|0.7918
91625985|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.2514|TWO_SIDED|95.0|0.79|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.79|0.2514
91625986|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.88|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.88|0.9872
91625987|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.78|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.78|0.6304
91625988|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
91625989|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.8|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.80|0.6922
91625990|NCT01392378|183144361|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.9765|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.9765
91625991|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7148|TWO_SIDED|95.0|0.82|1.66||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.66|0.82|0.7148
91625992|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.7907|TWO_SIDED|95.0|0.75|1.45||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.45|0.75|0.7907
91625993|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.4765|TWO_SIDED|95.0|0.81|1.6||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.60|0.81|0.4765
91625994|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5037|TWO_SIDED|95.0|0.89|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.89|0.5037
91662987|NCT03649477|183221181|SUPERIORITY||Mean Difference (Net)|-0.498||||0.0266|TWO_SIDED|95.0|-0.937|-0.059||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.059|-0.937|0.0266
91662988|NCT03649477|183221182|SUPERIORITY||Mean Difference (Net)|-1.085||||0.2479|TWO_SIDED|95.0|-2.932|0.761||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.761|-2.932|0.2479
91713992|NCT04556760|183319566|OTHER||Mean Difference (Final Values)|5.7535||||0.005||95.0|2.6034|8.9036|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||8.9036|2.6034|0.005
91625995|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.52|2.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.17|0.52|0.9414
91662989|NCT03649477|183221182|SUPERIORITY||Mean Difference (Net)|-2.412||||0.0114|TWO_SIDED|95.0|-4.276|-0.548||0.05 for statistical significance|Mixed Models Analysis|||||-0.548|-4.276|0.0114
91713993|NCT04556760|183319566|OTHER||Mean Difference (Final Values)|9.0619||||0.023||95.0|1.674|16.4499|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||16.4499|1.6740|0.023
91713994|NCT02513550|183319570|SUPERIORITY||Risk Difference (RD)|7.9|||=|0.005|TWO_SIDED||||||Regression, Logistic|||||||=0.005
91713995|NCT02513550|183319570|SUPERIORITY||Risk Difference (RD)|1.9|||=|0.522|TWO_SIDED||||||Regression, Logistic|||||||=0.522
91662990|NCT00748072|183221187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Chi-squared|||The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level \<0.05 was calculated in 158 patients.||0.85|0.24|0.01
91625996|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.45|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.45|0.7907
91625997|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.29|TWO_SIDED|95.0|0.32|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.32|0.2900
91625998|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.44|1.77||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.77|0.44|0.8826
91625999|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.5823|TWO_SIDED|95.0|0.18|1.4||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.40|0.18|0.5823
91626000|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.27|1.8||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.80|0.27|0.7636
91626001|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.4||||0.2407|TWO_SIDED|95.0|0.14|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.14|0.2407
91626002|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.8826|TWO_SIDED|95.0|0.43|3.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||3.22|0.43|0.8826
91626003|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.0961|TWO_SIDED|95.0|0.26|0.81||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.81|0.26|0.0961
91626004|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.38|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.38|0.7636
91626005|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.29|TWO_SIDED|95.0|0.39|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.39|0.2900
91626006|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.8826|TWO_SIDED|95.0|0.6|1.82||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.82|0.60|0.8826
91626007|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.9925|TWO_SIDED|95.0|0.65|1.54||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.54|0.65|0.9925
91626008|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.52|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.52|0.7636
91626009|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3929|TWO_SIDED|95.0|0.53|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.53|0.3929
91626010|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.62|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.62|0.8826
91662991|NCT01750294|183221191|SUPERIORITY_OR_OTHER|||||||0.01||||||a = 0.05|Mixed Models Analysis|||||||0.01
91713996|NCT02513550|183319571|SUPERIORITY||Risk Difference (RD)|6.9|||=|0.006|TWO_SIDED||||||Regression, Logistic|||||||=0.006
91713997|NCT02513550|183319571|SUPERIORITY||Risk Difference (RD)|4.6|||=|0.118|TWO_SIDED||||||Regression, Logistic|||||||=0.118
91482128|NCT04340063|182838150|OTHER||Odds Ratio, log|-0.03||||0.8|TWO_SIDED|95.0|-0.22|0.16||Interaction effect for time (pre-, mid-, and post- assessments) by group (Movement Amplification)|Mixed Models Analysis|||||0.16|-0.22|0.8
91482129|NCT04340063|182838150|OTHER||Odds Ratio, log|0.09||||0.5|TWO_SIDED|95.0|-0.18|0.36||Effect of time (post-training and follow-up assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.36|-0.18|0.5
91482130|NCT04340063|182838150|OTHER||Odds Ratio, log|-0.07||||0.6|TWO_SIDED|95.0|-0.31|0.17||Interaction effect of time (post-training and follow-up assessments) by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.17|-0.31|0.6
91482131|NCT04340063|182838151|OTHER||Slope|0.06||||0.8|TWO_SIDED|95.0|-0.5|0.62||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and time by group (Treadmill or Movement Amplification) interaction were used||0.62|-0.50|0.8
91482132|NCT04340063|182838151|OTHER||Slope|-0.7||||0.012|TWO_SIDED|95.0|-1.2|-0.16||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||-0.16|-1.2|0.012
91482133|NCT04340063|182838151|OTHER||Slope|0.26||||0.3|TWO_SIDED|95.0|-0.22|0.75||Effect of time (post-training to follow-up)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.75|-0.22|0.3
91482134|NCT04340063|182838151|OTHER||Slope|-0.2||||0.4|TWO_SIDED|95.0|-0.69|0.29||Interaction effect of time (post-training to follow-up) by group|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.29|-0.69|0.4
91482135|NCT04340063|182838152|OTHER||Slope|-52.0||||0.9|TWO_SIDED|95.0|-651.0|456.0||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||456|-651|0.9
91482136|NCT04340063|182838152|OTHER||Slope|79.0||||0.8|TWO_SIDED|95.0|-622.0|780.0||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||780|-622|0.8
91482137|NCT00491556|182838170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.08|STANDARD_DEVIATION|5.13|<|0.0001|TWO_SIDED|95.0|-12.2|-7.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-7.97|-12.20|<0.0001
91482138|NCT00491556|182838171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_DEVIATION|5.0||0.0834|TWO_SIDED|95.0|-3.87|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||0.26|-3.87|0.0834
91482139|NCT00491556|182838172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-317.36|STANDARD_DEVIATION|176.07|<|0.0001|TWO_SIDED|95.0|-390.04|-244.68|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-244.68|-390.04|<0.0001
91525247|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-29.22||||0.015|TWO_SIDED|95.0|-52.84|-5.59|||Mixed Models Analysis|||||-5.59|-52.84|0.015
91482140|NCT00491556|182838173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|242.38||0.6222|TWO_SIDED|95.0|-124.25|75.85|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||75.85|-124.25|0.6222
91525248|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-54.61|||<|0.001|TWO_SIDED|95.0|-69.63|-39.59|||Mixed Models Analysis|||||-39.59|-69.63|<0.001
91525249|NCT04867785|182925762|SUPERIORITY||LSMean Difference|33.54|||<|0.001|TWO_SIDED|95.0|18.26|48.82|||Mixed Models Analysis|||||48.82|18.26|<0.001
91626011|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7433|TWO_SIDED|95.0|0.7|2.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.20|0.70|0.7433
91626012|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.46|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.46|0.7636
91626013|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.2407|TWO_SIDED|95.0|0.34|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.34|0.2407
91713998|NCT02849743|183319589|OTHER||Least Means Square|-0.5||||0.92|TWO_SIDED||||||Regression, Linear|||||||0.92
91713999|NCT02849743|183319590|OTHER||Regression Coefficient|-15784.0||||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
91482141|NCT00491556|182838174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.79|STANDARD_DEVIATION|152.57||0.0781|TWO_SIDED|95.0|-124.77|7.18|||t-test, 2 sided|||Null hypothesis is no changes between Baseline and Week 48.||7.18|-124.77|0.0781
91482142|NCT00491556|182838175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.53|STANDARD_DEVIATION|176.61||0.0102|TWO_SIDED|95.0|-179.9|-27.16|||t-test, 2 sided|||Null hypothesis is no changes between Week 48 and Week 152||-27.16|-179.90|0.0102
91626014|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8826|TWO_SIDED|95.0|0.61|1.83||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.83|0.61|0.8826
91626015|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.9414|TWO_SIDED|95.0|0.51|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.51|0.9414
91626016|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7636|TWO_SIDED|95.0|0.68|2.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.14|0.68|0.7636
91626017|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.738|TWO_SIDED|95.0|0.5|1.63||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.63|0.50|0.7380
91626018|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.49|1.58||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.58|0.49|0.8826
91626019|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.67|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.67|0.9414
91626020|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.58|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.58|0.7907
91626021|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2407|TWO_SIDED|95.0|0.43|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.43|0.2407
91626022|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.02||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.02|0.42|0.2670
91626023|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.62|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.62|0.5823
91626024|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.65|0.7636
91626025|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.0422|TWO_SIDED|95.0|0.48|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.48|0.0422
91626026|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.53|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.53|0.2670
91714000|NCT02849743|183319591|OTHER||Regression Coefficient|48.0||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
91482143|NCT00491556|182838176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.13|STANDARD_DEVIATION|56.72||0.1616|TWO_SIDED|95.0|-41.66|7.4|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||7.40|-41.66|0.1616
91714001|NCT02849743|183319592|OTHER||Regression Coefficient|-2.8||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
91714002|NCT02849743|183319593|OTHER||Regression Coefficient|1.2||||0.86|TWO_SIDED||||||Regression, Linear|||||||0.86
91714003|NCT02849743|183319594|OTHER||Regression Coefficient|2.4||||0.88|TWO_SIDED||||||Regression, Linear|||||||0.88
91714004|NCT02849743|183319595|OTHER||Regression Coefficient|-0.02||||0.5|TWO_SIDED||||||Regression, Linear|||||||0.50
91525250|NCT04867785|182925762|SUPERIORITY||LSMean Difference|16.07||||0.231|TWO_SIDED|95.0|-10.25|42.39|||Mixed Models Analysis|||||42.39|-10.25|0.231
91662992|NCT02832063|183221226|EQUIVALENCE|Primary efficacy power calculations assume a \>25% difference between B244 treatment and placebo and a 15% dropout. Each of the endpoints comprising the co-primary endpoint will be tested at an alpha level of p\<0.05. In order to achieve 90% power with a 5% Type I error rate, a total of 372 participants is required.||||||0.034|||||||ANCOVA|||||||0.034
91662993|NCT00772603|183221241|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.3|||=|0.003|TWO_SIDED|95.0|-30.4|-5.8||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-5.80|-30.40|=0.003
91662994|NCT00772603|183221241|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.3|||=|0.078|TWO_SIDED|95.0|-22.3|1.2||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||1.20|-22.30|=0.078
91662995|NCT00772603|183221242|SUPERIORITY_OR_OTHER||Median Difference (Net)|-33.0|||=|0.003|TWO_SIDED|95.0|-33.0|-6.3||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-6.30|-33.00|=0.003
91662996|NCT00772603|183221242|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.3|||=|0.589|TWO_SIDED|95.0|-16.2|9.7||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||9.70|-16.20|=0.589
91662997|NCT00772603|183221243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983|||=|0.018|TWO_SIDED|95.0|1.126|3.494|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||3.494|1.126|=0.018
91662998|NCT00772603|183221243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||=|0.075||95.0|0.95|2.937|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||2.937|0.950|=0.075
91662999|NCT00772603|183221244|SUPERIORITY_OR_OTHER||||||=|0.013||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.013
91663000|NCT00772603|183221244|SUPERIORITY_OR_OTHER||||||=|0.528||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.528
91663001|NCT00772603|183221245|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.008
91663002|NCT00772603|183221245|SUPERIORITY_OR_OTHER||||||=|0.0546||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.0546
91663003|NCT00835575|183221246|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.52||||||90.0|92.84|106.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.69|92.84|
91663004|NCT00835575|183221247|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.59||||||90.0|99.13|108.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.25|99.13|
91663005|NCT00835575|183221248|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.87||||||90.0|99.47|108.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.46|99.47|
91663006|NCT00859521|183221254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.7||||||90.0|92.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|92.4|
91663007|NCT00859521|183221255|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|96.9|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|96.9|
91714005|NCT02849743|183319596|OTHER||Regression Coefficient|-0.02||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
91714006|NCT02849743|183319598|OTHER||Regression Coefficient|-0.7||||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
91626027|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8454|TWO_SIDED|95.0|0.72|1.78||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.78|0.72|0.8454
91714007|NCT02849743|183319599|OTHER||Regression Coefficient|-0.6||||0.52|TWO_SIDED||||||Regression, Linear|||||||0.52
91792008|NCT01857310|183461812|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.2|
91792009|NCT01857310|183461812|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.2|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.1|
91482144|NCT00491556|182838177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.08|STANDARD_DEVIATION|75.17||0.0117|TWO_SIDED|95.0|-75.59|-10.58|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||-10.58|-75.59|0.0117
91626028|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.7636|TWO_SIDED|95.0|0.81|2.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.00|0.81|0.7636
91626029|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2824|TWO_SIDED|95.0|0.45|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.45|0.2824
91626030|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5155|TWO_SIDED|95.0|0.83|2.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.06|0.83|0.5155
91626031|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.5823|TWO_SIDED|95.0|0.5|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.50|0.5823
91626032|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7636|TWO_SIDED|95.0|0.78|1.7||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.70|0.78|0.7636
91626033|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.4644|TWO_SIDED|95.0|0.56|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.56|0.4644
91626034|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.59|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.59|0.8826
91626035|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.61|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.61|0.5823
91626036|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.65|0.7636
91626037|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3299|TWO_SIDED|95.0|0.6|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.60|0.3299
91626038|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.54|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.54|0.2670
91626039|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.48|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.48|0.5823
91714008|NCT02849743|183319600|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Anxiety||||0.91
91714009|NCT02849743|183319600|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Depression||||0.91
91714010|NCT02849743|183319600|OTHER||Regression Coefficient|4.7||||0.04|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Cognition||||0.04
91482145|NCT00491556|182838178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-76.92|STANDARD_DEVIATION|56.31|<|0.0001|TWO_SIDED|95.0|-101.27|-52.57|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Week 48 and Week 152||-52.57|-101.27|< 0.0001
91663008|NCT00859521|183221256|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.8||||||90.0|97.2|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|97.2|
91663009|NCT01609257|183221257|SUPERIORITY_OR_OTHER|||||||0.674||||||No multiplicity adjustment.|Fisher Exact|||||||0.674
91663010|NCT01609257|183221264|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||||||0.001
91663011|NCT01609257|183221265|SUPERIORITY_OR_OTHER|||||||0.008||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 1||||0.008
91663012|NCT01609257|183221265|SUPERIORITY_OR_OTHER|||||||0.037||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 2||||0.037
91663013|NCT01609257|183221266|SUPERIORITY_OR_OTHER|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||||||0.199
91663014|NCT01609257|183221267|SUPERIORITY_OR_OTHER|||||||0.562||||||Comparison of % Positive|Fisher Exact|||Any Day 1 to 30||||0.562
91663015|NCT02125461|183221290|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.65|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.65|0.42|<0.0001
91663016|NCT02125461|183221291|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.00251|TWO_SIDED|95.0|0.53|0.87|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.87|0.53|0.00251
91663017|NCT02125461|183221292|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.||||<0.001
91663018|NCT02125461|183221296|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.68|0.41|<0.0001
91663019|NCT02125461|183221297|SUPERIORITY|||||||0.005||||||P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.|z-test|The variance was estimated using the delta method and Greenwood's formula.||||||0.005
91663020|NCT02125461|183221298|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.73|0.46|<0.0001
91663021|NCT02125461|183221299|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.664|TWO_SIDED|95.0|0.77|1.18||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.18|0.77|0.664
91663022|NCT02125461|183221300|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.522|TWO_SIDED|95.0|0.88|1.29||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.29|0.88|0.522
91663023|NCT02125461|183221300|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.74|1.12||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.12|0.74|0.380
91663024|NCT02125461|183221300|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.048|TWO_SIDED|95.0|0.56|1.0||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.00|0.56|0.048
91663025|NCT02125461|183221300|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.626|TWO_SIDED|95.0|0.75|1.19||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.19|0.75|0.626
91663026|NCT02645253|183221311|SUPERIORITY_OR_OTHER||Slope|1.02|STANDARD_ERROR_OF_MEAN|0.0785|||TWO_SIDED|90.0|0.882|1.15|||Linear Model|||||1.15|0.882|
91482146|NCT00491556|182838179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.87|STANDARD_DEVIATION|68.75||0.2519|TWO_SIDED|95.0|-12.86|46.6|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||46.60|-12.86|0.2519
91626040|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7907|TWO_SIDED|95.0|0.68|1.69||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.69|0.68|0.7907
91626041|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2742|TWO_SIDED|95.0|0.43|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.43|0.2742
91626042|NCT01392378|183144363|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.42|0.2670
91626043|NCT01392378|183144364|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.813|TWO_SIDED|95.0|0.71|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.71|0.813
91626044|NCT01392378|183144364|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.845|TWO_SIDED|95.0|0.79|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.79|0.845
91626045|NCT01392378|183144364|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.461|TWO_SIDED|95.0|0.65|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.65|0.461
91626046|NCT01392378|183144364|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.545|TWO_SIDED|95.0|0.68|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.68|0.545
91626047|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.712|TWO_SIDED|95.0|0.79|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.79|0.712
91626048|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.837|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.837
91626049|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.357|TWO_SIDED|95.0|0.78|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.78|0.357
91626050|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.19|TWO_SIDED|95.0|0.76|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.76|0.190
91626051|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.813|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.813
91626052|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.136|TWO_SIDED|95.0|0.73|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.73|0.136
91663027|NCT02645253|183221313|SUPERIORITY_OR_OTHER||Slope|1.14|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|90.0|1.06|1.23|||Linear Model|||||1.23|1.06|
91626053|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.104|TWO_SIDED|95.0|0.74|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.74|0.104
91626054|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.85||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.85|0.64|<0.001
91663028|NCT02645253|183221315|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|90.0|0.801|1.31|||Linear Model|||||1.31|0.801|
91663029|NCT02645253|183221325|SUPERIORITY_OR_OTHER||Slope|0.979|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|0.87|1.09|||Linear Model|||||1.09|0.870|
91663030|NCT02645253|183221330|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.0552|||TWO_SIDED|90.0|0.951|1.14|||Linear Model|||||1.14|0.951|
91626055|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.712|TWO_SIDED|95.0|0.72|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.72|0.712
91626056|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.206|TWO_SIDED|95.0|0.7|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.70|0.206
91663031|NCT02645253|183221342|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|102.99|||||TWO_SIDED|95.0|86.88|122.09|||ANCOVA||Day 1/ Day -1|||122.09|86.88|
91663032|NCT02645253|183221342|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|91.82|||||TWO_SIDED|95.0|77.32|109.04|||ANCOVA||Day 16 / Day -1|||109.04|77.32|
91663033|NCT02645253|183221342|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|105.92|||||TWO_SIDED|95.0|89.4|125.49|||ANCOVA||Day 1 / Day -1|||125.49|89.40|
91663034|NCT02645253|183221342|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|89.44|||||TWO_SIDED|95.0|75.35|106.16|||ANCOVA||Day 16 / Day -1|||106.16|75.35|
91663035|NCT02645253|183221342|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|99.82|||||TWO_SIDED|95.0|84.12|118.46|||ANCOVA||Day 1 / Day -1|||118.46|84.12|
91663036|NCT02645253|183221342|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|75.38||||||95.0|63.4|89.61|||ANCOVA||Day 16 / Day -1|||89.61|63.40|
91663037|NCT03552484|183221355|SUPERIORITY||Median Difference (Final Values)|0.05||||0.59|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Within-group paired t-tests and between-group paired t-tests||||0.59
91626057|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.78||||0.066|TWO_SIDED|95.0|0.65|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.65|0.066
91626058|NCT01392378|183144365|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.085|TWO_SIDED|95.0|0.67|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.67|0.085
91626059|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.712|TWO_SIDED|95.0|0.77|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.77|0.712
91663038|NCT03552484|183221356|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.59|TWO_SIDED|95.0||||Between-group comparison|t-test, 2 sided|||||||0.59
91663039|NCT03552484|183221357|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.62|TWO_SIDED|||||Between-group comparison of change in Multidimensional Caregiver Strain Index|t-test, 2 sided|||||||0.62
91663040|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.06|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least means squares from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.06
91663041|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.008|TWO_SIDED|||||p\< 0.05 was considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.008
91663042|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|||||p\< 0.05 was considered to be significant.|Mixed Models Analysis|||Comparison of Week 12 mean for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.07
91663043|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means.|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.003|TWO_SIDED|||||p\<0.05 is considered as being significant.|ANOVA|||Comparison of Week 10 mean for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates,||||0.003
91663044|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.4|STANDARD_ERROR_OF_MEAN|1.1||0.0002|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. .||||0.0002
91663045|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.1|STANDARD_ERROR_OF_MEAN|1.2||0.0007|TWO_SIDED||||||ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0007
91714011|NCT02849743|183319600|OTHER||Regression Coefficient|2.3||||0.36|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Social Function||||0.36
91714012|NCT02849743|183319601|OTHER||Regression Coefficient|0.05||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
91482147|NCT00491556|182838180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.79|STANDARD_DEVIATION|105.61|<|0.0001|TWO_SIDED|95.0|-172.46|-81.12|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-81.12|-172.46|< 0.0001
91525251|NCT04867785|182925762|SUPERIORITY||LSMean Difference|2.37||||0.804|TWO_SIDED|95.0|-16.28|21.01|||Mixed Models Analysis|||||21.01|-16.28|0.804
91626060|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.206|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.206
91626061|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.104|TWO_SIDED|95.0|0.72|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.72|0.104
91626062|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|0.74||||0.001|TWO_SIDED|95.0|0.63|0.87||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.87|0.63|0.001
91626063|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.813|TWO_SIDED|95.0|0.82|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.82|0.813
91626064|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.837|TWO_SIDED|95.0|0.9|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.90|0.837
91626065|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.534|TWO_SIDED|95.0|0.81|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.81|0.534
91626066|NCT01392378|183144366|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.87|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.87|0.961
91626067|NCT01392378|183144367|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.85|TWO_SIDED|95.0|0.75|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.75|0.850
91626068|NCT01392378|183144367|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.837|TWO_SIDED|95.0|0.77|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.77|0.837
91626069|NCT01392378|183144367|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.695|TWO_SIDED|95.0|0.69|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.69|0.695
91626070|NCT01392378|183144367|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.408|TWO_SIDED|95.0|0.6|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.60|0.408
91626071|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.813|TWO_SIDED|95.0|0.69|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.69|0.813
91626072|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.837|TWO_SIDED|95.0|0.68|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.68|0.837
91626073|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.695|TWO_SIDED|95.0|0.68|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.68|0.695
91482148|NCT00491556|182838181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.64|STANDARD_DEVIATION|97.71||0.0003|TWO_SIDED|95.0|45.39|129.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||129.90|45.39|0.0003
91525252|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-19.83|||<|0.001|TWO_SIDED|95.0|-31.01|-8.65|||Mixed Models Analysis|||||-8.65|-31.01|<0.001
91525253|NCT04867785|182925762|SUPERIORITY||LSMean Difference|6.45||||0.586|TWO_SIDED|95.0|-16.75|29.65|||Mixed Models Analysis|||||29.65|-16.75|0.586
91482149|NCT00491556|182838182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.46|STANDARD_DEVIATION|213.77||0.3739|TWO_SIDED|95.0|-51.98|132.9|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||132.90|-51.98|0.3739
91525254|NCT04867785|182925762|SUPERIORITY||LSMean Difference|-18.94||||0.002|TWO_SIDED|95.0|-30.93|-6.96|||Mixed Models Analysis|||||-6.96|-30.93|0.002
91525255|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-0.25||||0.984|TWO_SIDED|95.0|-24.57|24.07|||Mixed Models Analysis|||||24.07|-24.57|0.984
91663046|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.1||0.15|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.15
91663047|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.014|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariate values.||||0.014
91663048|NCT00862563|183221438|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.1|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means s from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.1
91663049|NCT00862563|183221439|SUPERIORITY_OR_OTHER||Mean difference Week 12|8.9|STANDARD_ERROR_OF_MEAN|3.6||0.015|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison between mean values obtained for the topiramate and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.015
91663050|NCT00862563|183221439|SUPERIORITY_OR_OTHER||Mean Difference Week 12|0.98|STANDARD_ERROR_OF_MEAN|3.6||0.784|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis.||||0.784
91663051|NCT00862563|183221439|SUPERIORITY_OR_OTHER||Mean difference Week 12|3.65|STANDARD_ERROR_OF_MEAN|3.3||0.264|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.264
91663052|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.4|STANDARD_ERROR_OF_MEAN|9.7||0.013|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.013
91714013|NCT02849743|183319602|OTHER||Regression Coefficient|0.05||||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
91714014|NCT03677635|183319605|OTHER||Standardised Effect Size|0.32|||||TWO_SIDED|95.0|0.21|0.86|||Standardised Effect Size|||||.86|.21|
91482150|NCT00491556|182838183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.86|STANDARD_DEVIATION|166.4||0.0147|TWO_SIDED|95.0|-163.82|-19.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-19.90|-163.82|0.0147
91482151|NCT00491556|182838184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.81|STANDARD_DEVIATION|76.07|<|0.0001|TWO_SIDED|95.0|46.92|112.71|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||112.71|46.92|< 0.0001
91525256|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-4.2||||0.804|TWO_SIDED|95.0|-37.44|29.03|||Mixed Models Analysis|||||29.03|-37.44|0.804
91525257|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-21.47||||0.167|TWO_SIDED|95.0|-51.91|8.98|||Mixed Models Analysis|||||8.98|-51.91|0.167
91525258|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-51.84|||<|0.001|TWO_SIDED|95.0|-76.09|-27.59|||Mixed Models Analysis|||||-27.59|-76.09|<0.001
91626074|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.961|TWO_SIDED|95.0|0.71|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.71|0.961
91626075|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|1.18||||0.808|TWO_SIDED|95.0|0.85|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.85|0.808
91626076|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.837|TWO_SIDED|95.0|0.8|1.5||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.50|0.80|0.837
91626077|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.695|TWO_SIDED|95.0|0.66|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.66|0.695
91626078|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.82||||0.408|TWO_SIDED|95.0|0.58|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.58|0.408
91482152|NCT00491556|182838185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_DEVIATION|58.18||0.1067|TWO_SIDED|95.0|-45.56|4.76|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||4.76|-45.56|0.1067
91482153|NCT00491556|182838186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.82|STANDARD_DEVIATION|107.8||0.0005|TWO_SIDED|95.0|44.2|137.43|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||137.43|44.20|0.0005
91626079|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|1.07||||0.813|TWO_SIDED|95.0|0.78|1.46||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.46|0.78|0.813
91626080|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.343|TWO_SIDED|95.0|0.59|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.59|0.343
91626081|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|1.12||||0.695|TWO_SIDED|95.0|0.82|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.82|0.695
91626082|NCT01392378|183144368|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.925|TWO_SIDED|95.0|0.69|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.69|0.925
91482154|NCT00491556|182838187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.49|STANDARD_DEVIATION|64.41||0.0207|TWO_SIDED|95.0|5.64|61.34|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||61.34|5.64|0.0207
91714015|NCT03677635|183319606|OTHER|Cohen's d was reported.|Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.59|0.48|||Standardised Effect Size|||||.48|-.59|
91482155|NCT00491556|182838188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.37|STANDARD_DEVIATION|145.62||0.2082|TWO_SIDED|95.0|-102.34|23.6|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Week 48 and Week 152.||23.60|-102.34|0.2082
91525259|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-23.94||||0.168|TWO_SIDED|95.0|-57.94|10.06|||Mixed Models Analysis|||||10.06|-57.94|0.168
91714016|NCT02168491|183319607|SUPERIORITY_OR_OTHER||||||<|0.02|||||||paired t test|||||||<0.02
91482156|NCT00491556|182838189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.98|STANDARD_DEVIATION|139.33||0.0067|TWO_SIDED|95.0|26.73|147.23|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||147.23|26.73|0.0067
91482157|NCT00491556|182838190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.07|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|-23.78|-12.36|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-12.36|-23.78|< 0.0001
91482158|NCT00491556|182838191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|14.2||0.5815|TWO_SIDED|95.0|-4.48|7.8|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||7.80|-4.48|0.5815
91482159|NCT00491556|182838192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.24|STANDARD_DEVIATION|7.82|<|0.0001|TWO_SIDED|95.0|7.85|14.62|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||14.62|7.85|< 0.0001
91482160|NCT00491556|182838193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_DEVIATION|6.93||0.0594|TWO_SIDED|95.0|-5.87|0.12|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.12|-5.87|0.0594
91482161|NCT00491556|182838194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.58|STANDARD_DEVIATION|10.24||0.0001|TWO_SIDED|95.0|8.15|17.01|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.01|8.15|0.0001
91482162|NCT00491556|182838195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|STANDARD_DEVIATION|10.95||0.0995|TWO_SIDED|95.0|-0.81|8.66|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||8.66|-0.81|0.0995
91482163|NCT00491556|182838196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|2.07||0.0002|TWO_SIDED|95.0|1.05|2.84|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||2.84|1.05|0.0002
91525260|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-50.58|||<|0.001|TWO_SIDED|95.0|-74.94|-26.22|||Mixed Models Analysis|||||-26.22|-74.94|<0.001
91626083|NCT01392378|183144369|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.91|TWO_SIDED|95.0|0.81|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.81|0.910
91626084|NCT01392378|183144369|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.79|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.79|0.850
91626085|NCT01392378|183144369|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.868|TWO_SIDED|95.0|0.7|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.70|0.868
91714017|NCT02168491|183319608|SUPERIORITY_OR_OTHER|||||||0.24|||||||paired t test|||||||0.24
91714018|NCT02168491|183319609|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t test|||||||0.28
91626086|NCT01392378|183144369|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.914|TWO_SIDED|95.0|0.67|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.67|0.914
91626087|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.91|TWO_SIDED|95.0|0.89|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.89|0.910
91626088|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.850
91792010|NCT01857310|183461813|SUPERIORITY||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.1|-12.5|3.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.9|-12.5|
91626089|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.961
91626090|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.916|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.916
91626091|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.91|TWO_SIDED|95.0|0.87|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.87|0.910
91626092|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.909|TWO_SIDED|95.0|0.89|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.89|0.909
91626093|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.868|TWO_SIDED|95.0|0.93|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.93|0.868
91626094|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.81|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.81|0.914
91626095|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.91|TWO_SIDED|95.0|0.76|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.76|0.910
91626096|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.85|TWO_SIDED|95.0|0.76|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.76|0.850
91626097|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.868|TWO_SIDED|95.0|0.78|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.78|0.868
91792011|NCT01857310|183461813|SUPERIORITY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.1|-13.6|3.1|||||Weighted for loss to follow-up and adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.1|-13.6|
91792012|NCT01857310|183461814|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.1|-2.5|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.5|-2.5|
91792013|NCT01857310|183461814|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.1|-2.7|1.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.4|-2.7|
91525261|NCT04867785|182925763|SUPERIORITY||LSMean Difference|10.02||||0.362|TWO_SIDED|95.0|-11.55|31.6|||Mixed Models Analysis|||||31.60|-11.55|0.362
91626098|NCT01392378|183144370|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.76|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.76|0.914
91626099|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.91|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.910
91626100|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.85|TWO_SIDED|95.0|0.82|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.82|0.850
91792014|NCT01857310|183461815|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.8|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0.1|-0.8|
91792015|NCT01857310|183461815|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.9|0.0|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0|-0.9|
91792016|NCT01857310|183461816|SUPERIORITY||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|0.5|4.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.4|0.5|
91792017|NCT01857310|183461816|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|0.3|4.3|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.3|0.3|
91792018|NCT01857310|183461817|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-19.7|22.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||22.5|-19.7|
91792019|NCT01857310|183461817|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-20.9|21.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||21.4|-20.9|
91792020|NCT01857310|183461818|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|3.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.0|-4.7|
91792021|NCT01857310|183461818|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.91|1.09|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.09|0.91|
91792022|NCT01857310|183461819|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.9|2.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.9|
91663053|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.9|STANDARD_ERROR_OF_MEAN|9.8||0.036|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.036
91525262|NCT04867785|182925763|SUPERIORITY||LSMean Difference|6.07||||0.696|TWO_SIDED|95.0|-24.34|36.48|||Mixed Models Analysis|||||36.48|-24.34|0.696
91626101|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.939|TWO_SIDED|95.0|0.86|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.86|0.939
91626102|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.279|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.279
91626103|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.149|TWO_SIDED|95.0|0.76|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.76|0.149
91626104|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.85|TWO_SIDED|95.0|0.91|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.91|0.850
91663054|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.8|STANDARD_ERROR_OF_MEAN|9.9||0.24|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.24
91626105|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.394|TWO_SIDED|95.0|0.79|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.79|0.394
91626106|NCT01392378|183144371|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.916|TWO_SIDED|95.0|0.87|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.87|0.916
91626107|NCT01392378|183144372|SUPERIORITY_OR_OTHER||GMC Ratio|1.26||||0.869|TWO_SIDED|95.0|0.9|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.90|0.869
91626108|NCT01392378|183144372|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.85|TWO_SIDED|95.0|0.78|1.48||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.48|0.78|0.850
91626109|NCT01392378|183144372|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.868|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.868
91626110|NCT01392378|183144372|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.916|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.916
91626111|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.91|TWO_SIDED|95.0|0.78|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.78|0.910
91626112|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|1.05||||0.85|TWO_SIDED|95.0|0.83|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.83|0.850
91626113|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.868|TWO_SIDED|95.0|0.87|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.87|0.868
91792023|NCT01857310|183461819|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.08|0.89|
91792024|NCT01857310|183461820|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.5|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||0.6|-0.5|
91626114|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|1.02||||0.916|TWO_SIDED|95.0|0.81|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.81|0.916
91626115|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.99||||0.91|TWO_SIDED|95.0|0.79|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.79|0.910
91626116|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.85|TWO_SIDED|95.0|0.76|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.76|0.850
91626117|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.868|TWO_SIDED|95.0|0.77|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.77|0.868
91626118|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.916|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.916
91626119|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.97||||0.91|TWO_SIDED|95.0|0.77|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.77|0.910
91626120|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.84||||0.85|TWO_SIDED|95.0|0.67|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.67|0.850
91626121|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.939|TWO_SIDED|95.0|0.78|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.78|0.939
91626122|NCT01392378|183144373|SUPERIORITY_OR_OTHER||GMT Ratio|0.96||||0.916|TWO_SIDED|95.0|0.76|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.76|0.916
91626123|NCT00180271|183144383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84||The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.|Log Rank||A Hazard ratio \< 1.0 would indicate that the result favors CRT-D.|The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.||0.84|0.52|< 0.001
91626124|NCT00180271|183144384|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.53|0.86|||Andersen-Gill|Andersen-Gill model performed, adjusted for a previous HF event in the study, stratified by ischemic status and using robust variance estimation.|Model adjusted for previously experienced heart failure event in the study. Hazard Ratio (95% CI) comparing patients with a previous heart failure event to those patients without a prior heart failure event equaled 8.84 (6084, 11.43), p\<0.001.|||0.86|0.53|0.001
91626125|NCT00788697|183144392|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|11.3||||0.0754|TWO_SIDED|95.0|-1.0|23.6|||McNemar|||||23.6|-1.0|0.0754
91626126|NCT00788697|183144392|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|19.4||||0.0011|TWO_SIDED|95.0|8.3|30.5|||McNemar|||||30.5|8.3|0.0011
91626127|NCT00788697|183144392|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|-19.4||||0.0016|TWO_SIDED|95.0|-30.9|-7.8|||McNemar|||||-7.8|-30.9|0.0016
91626128|NCT00788697|183144393|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|47.4|||<|0.0001|TWO_SIDED|95.0|37.4|57.4|||McNemar|||||57.4|37.4|<.0001
91626129|NCT00788697|183144393|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|60.3|||<|0.0001|TWO_SIDED|95.0|50.5|70.2|||McNemar|||||70.2|50.5|<.0001
91626130|NCT00788697|183144393|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|29.3|||<|0.0001|TWO_SIDED|95.0|19.7|38.9|||McNemar|||||38.9|19.7|<.0001
91626131|NCT00788697|183144394|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|28.8|||<|0.0001|TWO_SIDED|95.0|20.5|37.0|||McNemar|||||37.0|20.5|<.0001
91626132|NCT00788697|183144394|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|39.2|||<|0.0001|TWO_SIDED|95.0|31.3|47.1|||McNemar|||||47.1|31.3|<.0001
91626133|NCT00788697|183144394|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|4.2||||0.3173|TWO_SIDED|95.0|-4.0|12.3|||McNemar|||||12.3|-4.0|0.3173
91626134|NCT00788697|183144395|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91626135|NCT00788697|183144395|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91626136|NCT00788697|183144395|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wald Test|||||||0.0004
91626137|NCT00788697|183144396|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91626138|NCT00788697|183144396|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
91626139|NCT00788697|183144396|SUPERIORITY_OR_OTHER|||||||0.761|||||||Wald Test|||||||0.7610
91482164|NCT00491556|182838197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|1.49||0.915|TWO_SIDED|95.0|-0.61|0.68|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.68|-0.61|0.9150
91482165|NCT00491556|182838198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.52|STANDARD_DEVIATION|13.79|<|0.0001|TWO_SIDED|95.0|-29.48|-17.55|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.55|-29.48|< 0.0001
91482166|NCT00491556|182838199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|16.96||0.5864|TWO_SIDED|95.0|-5.38|9.28|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||9.28|-5.38|0.5864
91482167|NCT00491556|182838200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.98|STANDARD_DEVIATION|8.48|<|0.0001|TWO_SIDED|95.0|18.31|25.65|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||25.65|18.31|< 0.0001
91482168|NCT00491556|182838201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|7.25||0.1592|TWO_SIDED|95.0|-5.34|0.93|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.93|-5.34|0.1592
91482169|NCT00491556|182838202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_DEVIATION|11.04||0.042|TWO_SIDED|95.0|0.2|9.74|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||9.74|0.20|0.0420
91525263|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-11.19||||0.436|TWO_SIDED|95.0|-39.38|16.99|||Mixed Models Analysis|||||16.99|-39.38|0.436
91525264|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-41.57|||<|0.001|TWO_SIDED|95.0|-62.89|-20.25|||Mixed Models Analysis|||||-20.25|-62.89|<0.001
91525265|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-13.67||||0.418|TWO_SIDED|95.0|-46.75|19.42|||Mixed Models Analysis|||||19.42|-46.75|0.418
91626140|NCT01998880|183144403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.36|0.59||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.59|0.36|<0.0001
91525266|NCT04867785|182925763|SUPERIORITY||LSMean Difference|-40.31|||<|0.001|TWO_SIDED|95.0|-60.77|-19.85|||Mixed Models Analysis|||||-19.85|-60.77|<0.001
91525267|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-0.49||||0.54|TWO_SIDED|95.0|-2.07|1.08|||Mixed Models Analysis|||||1.08|-2.07|0.540
91626141|NCT01998880|183144405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.31|0.5|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.50|0.31|<0.0001
91626142|NCT01998880|183144406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2841|TWO_SIDED|95.0|0.61|1.16|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||1.16|0.61|0.2841
91626143|NCT01998880|183144407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.31|||<|0.0001|TWO_SIDED|95.0|23.5|45.1|||Chi-squared|||||45.1|23.5|<0.0001
91626144|NCT01998880|183144409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.61|||Log-ranked, Stratified||Stratified by Binet stage at Baseline.|||0.61|0.35|<0.0001
91626145|NCT01998880|183144413|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.4|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.53|0.30|<0.0001
91626146|NCT01998880|183144414|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.65|0.31|<0.0001
91482170|NCT00491556|182838203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|12.39||0.4029|TWO_SIDED|95.0|-7.56|3.16|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||3.16|-7.56|0.4029
91482171|NCT00491556|182838204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_DEVIATION|6.03|<|0.0001|TWO_SIDED|95.0|11.99|17.21|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.21|11.99|< 0.0001
91482172|NCT00491556|182838205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14|STANDARD_DEVIATION|6.2||0.0239|TWO_SIDED|95.0|-5.81|-0.46|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.46|-5.81|0.0239
91482173|NCT00491556|182838206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.35|STANDARD_DEVIATION|10.26|<|0.0001|TWO_SIDED|95.0|-23.79|-14.91|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-14.91|-23.79|< 0.0001
91482174|NCT00491556|182838207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.6||0.2363|TWO_SIDED|95.0|-9.33|2.43|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||2.43|-9.33|0.2363
91482175|NCT00491556|182838208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.69|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.0|15.93|23.45|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||23.45|15.93|< 0.0001
91525268|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-4.41|||<|0.001|TWO_SIDED|95.0|-6.69|-2.13|||Mixed Models Analysis|||||-2.13|-6.69|<0.001
91525269|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-6.78|||<|0.001|TWO_SIDED|95.0|-9.47|-4.09|||Mixed Models Analysis|||||-4.09|-9.47|<0.001
91525270|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-10.13|||<|0.001|TWO_SIDED|95.0|-12.24|-8.03|||Mixed Models Analysis|||||-8.03|-12.24|<0.001
91525271|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-12.06|||<|0.001|TWO_SIDED|95.0|-15.06|-9.06|||Mixed Models Analysis|||||-9.06|-15.06|<0.001
91525272|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-10.99|||<|0.001|TWO_SIDED|95.0|-13.24|-8.73|||Mixed Models Analysis|||||-8.73|-13.24|<0.001
91525273|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-1.19||||0.135|TWO_SIDED|95.0|-2.75|0.37|||Mixed Models Analysis|||||0.37|-2.75|0.135
91525274|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-5.11|||<|0.001|TWO_SIDED|95.0|-7.36|-2.86|||Mixed Models Analysis|||||-2.86|-7.36|<0.001
91525275|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-7.48|||<|0.001|TWO_SIDED|95.0|-10.19|-4.77|||Mixed Models Analysis|||||-4.77|-10.19|<0.001
91663055|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-33.0|STANDARD_ERROR_OF_MEAN|9.0||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
91525276|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-10.83|||<|0.001|TWO_SIDED|95.0|-12.89|-8.77|||Mixed Models Analysis|||||-8.77|-12.89|<0.001
91663056|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-29.7|STANDARD_ERROR_OF_MEAN|9.2||0.0015|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0015
91663057|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-37.7|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
91714019|NCT00809445|183319610|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.52|||<|0.001|TWO_SIDED|97.5|3.57|5.72||a-prior threshold for statistical significance is .025|Cochran-Mantel-Haenszel||The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm|Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||5.72|3.57|<0.001
91792025|NCT01857310|183461820|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.37|3.97|||||Adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.97|0.37|
91792026|NCT01857310|183461821|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-3.7|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.5|-3.7|
91792027|NCT01857310|183461821|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.15|0.75|
91792028|NCT01857310|183461822|SUPERIORITY||Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.3|-1.9|
91792029|NCT01857310|183461822|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.63|1.36|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.36|0.63|
91792030|NCT01857310|183461823|SUPERIORITY||Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||0.6|-1.9|
91626147|NCT01998880|183144415|SUPERIORITY||Difference in Response Rates|33.04|||<|0.0001|TWO_SIDED|95.0|22.1|43.9|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||43.9|22.1|< 0.0001
91626148|NCT00014911|183144446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||||TWO_SIDED|95.0|30.0|61.0|||Fisher Exact|||||61|30|
91626149|NCT00014911|183144447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.0|||||TWO_SIDED|95.0|16.0|44.0|||Fisher Exact|||||44|16|
91626150|NCT00014911|183144448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.0|||||TWO_SIDED|95.0|42.0|63.0|||Fisher Exact|||||63|42|
91626151|NCT05064332|183144454|OTHER||Ratio of Adjusted Geometric Means|101.43|||||TWO_SIDED|90.0|93.01|110.61||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.61|93.01|
91626152|NCT05064332|183144455|OTHER||Ratio of Adjusted Geometric Means|108.51|||||TWO_SIDED|90.0|98.85|119.11||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.11|98.85|
91525277|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-12.76|||<|0.001|TWO_SIDED|95.0|-15.74|-9.77|||Mixed Models Analysis|||||-9.77|-15.74|<0.001
91663058|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.7|STANDARD_ERROR_OF_MEAN|10.0||0.04|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.04
91663059|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-23.3|STANDARD_ERROR_OF_MEAN|10.2||0.025|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.025
91663060|NCT00862563|183221440|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.8|STANDARD_ERROR_OF_MEAN|10.3||0.018|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.018
91663061|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.5|STANDARD_ERROR_OF_MEAN|7.8||0.005|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.005
91663062|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.1|STANDARD_ERROR_OF_MEAN|7.9||0.003|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.003
91714020|NCT00809445|183319611|SUPERIORITY_OR_OTHER||incidence rate raios (IRR)|1.04||||0.39|TWO_SIDED|97.5|0.95|1.14||a-priori threshold for statistical significance is .025|generalized estimating equations (GEE)||Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group|Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||1.14|0.95|0.39
91482176|NCT00491556|182838209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|5.55||0.0929|TWO_SIDED|95.0|-4.43|0.37|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.37|-4.43|0.0929
91626153|NCT05064332|183144456|OTHER||Ratio of Adjusted Geometric Means|95.07|||||TWO_SIDED|90.0|84.44|107.04||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.04|84.44|
91626154|NCT05064332|183144457|OTHER||Ratio of Adjusted Geometric Means|117.99|||||TWO_SIDED|90.0|101.82|136.73||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||136.73|101.82|
91626155|NCT04532918|183144462|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|255.3|||||TWO_SIDED|90.0|208.7|312.3|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax||312.3|208.7|
91626156|NCT04532918|183144462|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|189.5|||||TWO_SIDED|90.0|154.0|233.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax||233.1|154.0|
91626157|NCT04532918|183144463|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|238.4|||||TWO_SIDED|90.0|207.6|273.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||273.8|207.6|
91626158|NCT04532918|183144463|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|148.9|||||TWO_SIDED|90.0|129.1|171.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||171.7|129.1|
91626159|NCT04532918|183144464|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|261.8|||||TWO_SIDED|90.0|229.8|298.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast||298.1|229.8|
91626160|NCT04532918|183144464|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|163.2|||||TWO_SIDED|90.0|142.8|186.6|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast||186.6|142.8|
91626161|NCT04532918|183144465|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|273.4|||||TWO_SIDED|90.0|227.9|328.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||328.1|227.9|
91663063|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least square means|-16.3|STANDARD_ERROR_OF_MEAN|8.0||0.044|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.044
91714021|NCT00809445|183319611|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|1.03||||0.81|TWO_SIDED|97.5|0.84|1.26||a-priori threshold for statistical significance is .025|Generalized estimating equations (GEE)||Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm|"The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group"||1.26|0.84|0.81
91714022|NCT00809445|183319612|SUPERIORITY_OR_OTHER|||||||0.044||||||a priori threshold for significance was .05|Chi-squared|Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles||||||0.044
91714023|NCT00809445|183319613|SUPERIORITY_OR_OTHER||||||<|0.0001||||||a-priori threshold for statistical significance is .05|Chi-squared|chi-square = 428.2466, Df=2||||||<0.0001
91714024|NCT02221648|183319686|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||||||0.4470
91714025|NCT02221648|183319687|SUPERIORITY_OR_OTHER|||||||0.0293|||||||Fisher Exact|||||||0.0293
91663064|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-38.1|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates.||||<0.0001
91663065|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-47.6|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
91663066|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-34.0|STANDARD_ERROR_OF_MEAN|9.2||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
91663067|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-19.3|STANDARD_DEVIATION|8.0||0.017|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.017
91663068|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-31.2|STANDARD_ERROR_OF_MEAN|8.1||0.0002|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.0002
91714026|NCT02221648|183319688|SUPERIORITY_OR_OTHER|||||||0.0448|||||||Fisher Exact|||||||0.0448
91714027|NCT00810069|183319692|SUPERIORITY_OR_OTHER|||||||0.213|TWO_SIDED|95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier Analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Kaplan-Meier Estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.213
91714028|NCT00810069|183319693|SUPERIORITY_OR_OTHER||survival rate difference|0.02||||0.653|TWO_SIDED|95.0|-0.06|0.1||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.10|-0.06|0.653
91714029|NCT00810069|183319694|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Analysis of early intervention strategy versus delayed intervention strategy||||0.947
91525278|NCT04867785|182925764|SUPERIORITY||LSMean Difference|-11.69|||<|0.001|TWO_SIDED|95.0|-13.9|-9.47|||Mixed Models Analysis|||||-9.47|-13.90|<0.001
91714030|NCT00810069|183319695|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for early intervention versus delayed intervention strategies.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Analysis of early intervention strategy versus delayed intervention strategy||||0.597
91714031|NCT00810069|183319696|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.624|TWO_SIDED|95.0|-0.22|0.13||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||0.13|-0.22|0.624
91792031|NCT01857310|183461823|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.47|1.27|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||1.27|0.47|
91525279|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-0.03||||0.979|TWO_SIDED|95.0|-2.18|2.12|||Mixed Models Analysis|||||2.12|-2.18|0.979
91482177|NCT00491556|182838210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_DEVIATION|8.94||0.1886|TWO_SIDED|95.0|-6.4|1.34|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||1.34|-6.40|0.1886
91626162|NCT04532918|183144465|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|275.9|||||TWO_SIDED|90.0|228.7|332.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||332.7|228.7|
91626163|NCT04532918|183144465|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|24.65|||||TWO_SIDED|90.0|19.15|31.72|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||31.72|19.15|
91626164|NCT04532918|183144465|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|37.82|||||TWO_SIDED|90.0|29.18|49.03|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||49.03|29.18|
91626165|NCT04532918|183144466|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|291.8|||||TWO_SIDED|90.0|260.6|326.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M1||326.8|260.6|
91626166|NCT04532918|183144466|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|215.8|||||TWO_SIDED|90.0|192.0|242.4|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||242.4|192.0|
91626167|NCT04532918|183144466|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|55.31|||||TWO_SIDED|90.0|47.19|64.83|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||64.83|47.19|
91663069|NCT00862563|183221441|SUPERIORITY_OR_OTHER||Difference between least squares means|-18.5|STANDARD_ERROR_OF_MEAN|8.2||0.026|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates.||||0.026
91663070|NCT00862563|183221442|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction term.'||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
91714032|NCT00810069|183319696|SUPERIORITY_OR_OTHER||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.208|TWO_SIDED|95.0|-0.29|0.06||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed Models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.06|-0.29|0.208
91482178|NCT00491556|182838211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87|STANDARD_DEVIATION|8.13||0.2831|TWO_SIDED|95.0|-1.65|5.38|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.38|-1.65|0.2831
91626168|NCT04532918|183144466|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|68.28|||||TWO_SIDED|90.0|57.99|80.39|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||80.39|57.99|
91626169|NCT04532918|183144467|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|306.4|||||TWO_SIDED|90.0|273.3|343.6|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||343.6|273.3|
91626170|NCT04532918|183144467|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|227.4|||||TWO_SIDED|90.0|202.1|255.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||255.8|202.1|
91626171|NCT04532918|183144467|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|51.03|||||TWO_SIDED|90.0|43.8|59.45|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||59.45|43.80|
91626172|NCT04532918|183144467|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|70.45|||||TWO_SIDED|90.0|60.21|82.44|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||82.44|60.21|
91626173|NCT04532918|183144468|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|74.84|||||TWO_SIDED|90.0|59.42|94.26|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||94.26|59.42|
91626174|NCT04532918|183144468|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|80.99|||||TWO_SIDED|90.0|63.88|102.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||102.7|63.88|
91626175|NCT04532918|183144468|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.86|||||TWO_SIDED|90.0|92.11|101.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||101.8|92.11|
91626176|NCT04532918|183144468|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.07|||||TWO_SIDED|90.0|94.36|104.0|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||104.0|94.36|
91714033|NCT00810069|183319696|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.044|TWO_SIDED|95.0|-0.37|0.0||P-value for Week 10: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||-0.00|-0.37|0.044
91626177|NCT04532918|183144469|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.29|||||TWO_SIDED|90.0|91.26|105.9|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||105.9|91.26|
91626178|NCT04532918|183144469|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|93.72|109.2|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||109.2|93.72|
91626179|NCT04532918|183144469|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.16|||||TWO_SIDED|90.0|95.02|103.5|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||103.5|95.02|
91626180|NCT04532918|183144469|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.05|||||TWO_SIDED|90.0|92.15|100.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||100.1|92.15|
91626181|NCT04532918|183144470|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.25|||||TWO_SIDED|90.0|91.1|106.0|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||106.0|91.10|
91626182|NCT04532918|183144470|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.6|||||TWO_SIDED|90.0|93.99|109.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||109.8|93.99|
91626183|NCT04532918|183144470|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.05|||||TWO_SIDED|90.0|94.5|101.7|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for oxypurinol||101.7|94.50|
91626184|NCT04532918|183144470|OTHER||Geometric Mean Ratio (%)|95.98|||||TWO_SIDED|90.0|92.61|99.48|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects||99.48|92.61|
91626185|NCT03788616|183144483|EQUIVALENCE|assuming 95% power of the study|Median Difference (Final Values)|0.05||||0.478|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.478
91626186|NCT03170258|183144488|OTHER|||||||0.0015|||||||t-test, 2 sided|One-sample 2-sided t-test against a mean of 0 used to evaluate the main effect of VTA activation during neurofeedback.||||||0.0015
91626187|NCT03170258|183144489|OTHER||||||>|0.1|||||||t-test, 1 sided|One-sample t-test against 0 for the ratio of Beta to Theta power.||||||>0.10
91626188|NCT04839393|183144497|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|108.86|||||TWO_SIDED|90.0|87.24|135.84|||Mixed Models Analysis|||||135.84|87.24|
91626189|NCT04839393|183144498|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio|113.14|||||TWO_SIDED|90.0|89.34|143.28|||Mixed Models Analysis|||||143.28|89.34|
91626190|NCT04839393|183144499|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|38.73|||||TWO_SIDED|90.0|32.8|45.74|||Mixed Models Analysis|||The test treatment was PF-06865571 300 mg + PF-06882961 200 mg BID (Period 3 - Day 47), which was reported separately in comparison to the reference treatment of PF-06865571 300 mg (Period 1 - Day 1).||45.74|32.80|
91626191|NCT04839393|183144500|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.91|||||TWO_SIDED|90.0|67.95|80.4|||Mixed Models Analysis|||||80.40|67.95|
91626192|NCT04839393|183144501|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.2|||||TWO_SIDED|90.0|66.82|80.18|||Mixed Models Analysis|||||80.18|66.82|
91626193|NCT04839393|183144502|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|85.37|155.73|||Mixed Models Analysis|||||155.73|85.37|
91626194|NCT04839393|183144503|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|118.64|||||TWO_SIDED|90.0|94.05|149.66|||Mixed Models Analysis|||||149.66|94.05|
91626195|NCT00671970|183144519|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91626196|NCT00671970|183144520|SUPERIORITY_OR_OTHER|||||||0.613||95.0|||||Fisher Exact|||||||.613
91626197|NCT00671970|183144521|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91626198|NCT00671970|183144522|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91626199|NCT00671970|183144523|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91626200|NCT00671970|183144524|SUPERIORITY_OR_OTHER|||||||0.179||95.0|||||Wilcoxon (Mann-Whitney)|||||||.179
91626201|NCT00671970|183144525|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||.008
91626202|NCT01094808|183144582|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|33.391|STANDARD_DEVIATION|22.106||0.14||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.14
91626203|NCT01094808|183144583|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|35.301|STANDARD_DEVIATION|22.295||0.12||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.12
91714034|NCT00810069|183319696|SUPERIORITY_OR_OTHER||LS Mean|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.086|TWO_SIDED|95.0|-0.35|0.02||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interactions, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.02|-0.35|0.086
91626204|NCT03051217|183144639|SUPERIORITY||Estimated difference in responder rate|65.1|||||TWO_SIDED|95.0|48.22|81.9|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||81.90|48.22|
91626205|NCT03051217|183144639|SUPERIORITY||Estimated difference in responder rate|79.1|||||TWO_SIDED|95.0|65.1|93.17|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||93.17|65.10|
91626206|NCT03051217|183144639|SUPERIORITY||Odds Ratio (OR)|31.695|||<|0.0001|TWO_SIDED|97.5|5.129|195.877||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||195.877|5.129|<0.0001
91626207|NCT03051217|183144639|SUPERIORITY||Odds Ratio (OR)|79.112|||<|0.0001|TWO_SIDED|97.5|11.739|533.168||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||533.168|11.739|<0.0001
91626208|NCT03051217|183144640|SUPERIORITY||Estimated difference in responder rate|52.7|||||TWO_SIDED|95.0|29.95|75.39|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||75.39|29.95|
91626209|NCT03051217|183144640|SUPERIORITY||Estimated difference in responder rate|66.7|||||TWO_SIDED|95.0|43.34|90.15|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||90.15|43.34|
91626210|NCT03051217|183144640|SUPERIORITY||Odds Ratio (OR)|38.193|||<|0.0001|TWO_SIDED|97.5|6.113|238.619||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||238.619|6.113|<0.0001
91626211|NCT03051217|183144640|SUPERIORITY||Odds Ratio (OR)|69.58|||<|0.0001|TWO_SIDED|97.5|11.138|434.659||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||434.659|11.138|<0.0001
91626212|NCT03051217|183144641|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|30.67|76.47|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||76.47|30.67|
91626213|NCT03051217|183144641|SUPERIORITY||Estimated difference in responder rate|75.5|||||TWO_SIDED|95.0|51.95|99.04|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||99.04|51.95|
91626214|NCT03051217|183144641|SUPERIORITY||Odds Ratio (OR)|38.696|||<|0.0001|TWO_SIDED|97.5|6.047|247.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||247.634|6.047|<0.0001
91663071|NCT00862563|183221442|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for group x time interaction term for the comparison of data for the topiramate and placebo group.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction.||||<0.0001
91663072|NCT00862563|183221442|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction.||||0.30
91482179|NCT00491556|182838212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.52|STANDARD_DEVIATION|5.59|<|0.0001|TWO_SIDED|95.0|9.1|13.94|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||13.94|9.10|< 0.0001
91482180|NCT00491556|182838213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21|STANDARD_DEVIATION|5.88||0.0157|TWO_SIDED|95.0|-5.75|-0.67|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.67|-5.75|0.0157
91525280|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-4.0||||0.018|TWO_SIDED|95.0|-7.32|-0.68|||Mixed Models Analysis|||||-0.68|-7.32|0.018
91663073|NCT00862563|183221443|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction effect for the paired comparison of COWAT-category data for the zonisamide and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.003
91663074|NCT00862563|183221443|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction||||0.01
91663075|NCT00862563|183221443|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction||||0.36
91663076|NCT00862563|183221444|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for the group x time interaction effect||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.07
91663077|NCT00862563|183221444|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group X time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
91663078|NCT00862563|183221444|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.95
91663079|NCT00862563|183221445|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Spatial Span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.038
91663080|NCT00862563|183221445|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||0.0025
91663081|NCT00862563|183221445|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.3
91482181|NCT00491556|182838214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.65|STANDARD_DEVIATION|12.93|<|0.0001|TWO_SIDED|95.0|-28.24|-17.06|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.06|-28.24|< 0.0001
91482182|NCT00491556|182838215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|15.37||0.1999|TWO_SIDED|95.0|-2.41|10.88|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||10.88|-2.41|0.1999
91525281|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-7.09|||<|0.001|TWO_SIDED|95.0|-10.46|-3.71|||Mixed Models Analysis|||||-3.71|-10.46|<0.001
91525282|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-16.74|-9.66|||Mixed Models Analysis|||||-9.66|-16.74|<0.001
91525283|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-12.84|||<|0.001|TWO_SIDED|95.0|-16.5|-9.18|||Mixed Models Analysis|||||-9.18|-16.50|<0.001
91525284|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-13.91|||<|0.001|TWO_SIDED|95.0|-17.1|-10.71|||Mixed Models Analysis|||||-10.71|-17.10|<0.001
91525285|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-1.34||||0.213|TWO_SIDED|95.0|-3.45|0.77|||Mixed Models Analysis|||||0.77|-3.45|0.213
91525286|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-5.31||||0.002|TWO_SIDED|95.0|-8.66|-1.97|||Mixed Models Analysis|||||-1.97|-8.66|0.002
91525287|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-8.4|||<|0.001|TWO_SIDED|95.0|-11.76|-5.04|||Mixed Models Analysis|||||-5.04|-11.76|<0.001
91525288|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-14.51|||<|0.001|TWO_SIDED|95.0|-18.0|-11.01|||Mixed Models Analysis|||||-11.01|-18.00|<0.001
91663082|NCT02663349|183221454|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|df = 14||Within sample analysis of change between baseline and 3 month assessment.||||.08
91663083|NCT02663349|183221455|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Within sample change between baseline and 6 month assessment.||||.69
91663084|NCT02663349|183221456|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|df=14||Within sample change assessed between baseline and 3-month assessment||||.02
91663085|NCT02663349|183221457|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|df = 14||Change between baseline and 6 month assessment||||.34
91792032|NCT01857310|183461824|SUPERIORITY||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-1.4|3.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||3.8|-1.4|
91663086|NCT02663349|183221458|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of change between baseline and 3-month assessment on the AIHQ Hostility scale||||>.05
91663087|NCT02663349|183221458|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Completer analysis to examine within group change between baseline and 3-month assessment on the AIHQ Aggression scale||||.04
91663088|NCT02663349|183221459|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Hostility scale between baseline and the 6-month assessment||||>.05
91663089|NCT02663349|183221459|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Aggression scale between baseline and the 6 month assessment||||> .05
91663090|NCT02663349|183221460|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Change within group between baseline and 3 month assessment on the TASIT total score for part 3||||> .05
91663091|NCT02663349|183221461|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||within group change on the TASIT total score for Part 3 between baseline and the 6 month assessment||||> .05
91663092|NCT02663349|183221462|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on SSPA Total Score between baseline and 3-month assessment||||>.05
91663093|NCT02663349|183221463|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on the SSPA total score between baseline and 6 month assessment||||> .05
91663094|NCT02663349|183221464|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change on the First Episode Social Functioning Scale Performance Total score on scales 1-7 between baseline and 3-month follow-up||||> .05
91663095|NCT02663349|183221465|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change between baseline and 6-month assessment on the First Episode Social Functioning Scale Performance total score on scales 1-7||||> .05
91663096|NCT02663349|183221466|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between Baseline and 3-Month assessments||||.15
91663097|NCT02663349|183221466|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 3-month assessments||||.10
91663098|NCT02663349|183221466|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 3-month assessment||||>.05
91663099|NCT02663349|183221466|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 3 month assessment||||> .05
91663100|NCT02663349|183221467|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between baseline and the 6-month assessment||||.01
91663101|NCT02663349|183221467|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 6-month assessment||||.03
91663102|NCT02663349|183221467|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 6-month assessment||||> .05
91663103|NCT02663349|183221467|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 6-month assessment||||> .05
91663104|NCT02663349|183221468|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Self Disclosure scale between Baseline and 3-Month Assessment||||.09
91663105|NCT02663349|183221468|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Workplace Coping scale between Baseline and 3-Month Assessment||||.12
91663106|NCT02663349|183221469|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Self Disclosure scale between Baseline and 6 month assessment||||> .05
91663107|NCT02663349|183221469|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Workplace Coping scale between baseline and the 6 month assessment||||> .05
91663108|NCT00848536|183221529|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
91663109|NCT00848536|183221530|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.8|0.6|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||00.6|-0.8|
91663110|NCT00848536|183221531|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
91626215|NCT03051217|183144641|SUPERIORITY||Odds Ratio (OR)|100.459|||<|0.0001|TWO_SIDED|97.5|15.54|649.437||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||649.437|15.540|<0.0001
91626216|NCT03051217|183144642|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.1|-3.844||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.844|-9.100|<0.0001
91626217|NCT03051217|183144642|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.099|-3.91||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.910|-9.099|<0.0001
91792033|NCT01857310|183461824|SUPERIORITY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.89|1.39|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||1.39|0.89|
91626218|NCT03051217|183144643|SUPERIORITY||Adjusted Mean Treatment Difference|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.265|-2.002||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-2.002|-4.265|<0.0001
91792034|NCT01857310|183461825|SUPERIORITY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|0.2|3.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||3.6|0.2|
91792035|NCT01857310|183461825|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|1.04|2.16|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||2.16|1.04|
91626219|NCT03051217|183144643|SUPERIORITY||Adjusted Mean Treatment Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.295|-3.069||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.069|-5.295|<0.0001
91626220|NCT01989754|183144646|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.57|0.73|||Cox proportional hazard method|||||0.73|0.57|<.0001
91626221|NCT01989754|183144647|SUPERIORITY||Hazard Ratio (HR)|0.72|||=|0.0148|TWO_SIDED|95.0|0.55|0.94|||Stratified Cox proportional hazard|||||0.94|0.55|=0.0148
91626222|NCT01989754|183144648|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.4067|TWO_SIDED|95.0|0.61|1.22|||Stratified Cox proportional hazard|||||1.22|0.61|=0.4067
91626223|NCT03364491|183144674|SUPERIORITY|Model included treatment and preoperative hemoglobin level \<8 g/dL (yes/no) as covariates. We estimated that a total sample size of 11,000 participants (5,500 per group) would achieve 85% power to detect a 33% lower incidence of the primary outcome (1.67%) in the TXA group, at a type I error rate (two-sided) of 5%.|Risk Ratio (RR)|0.89||||0.19|TWO_SIDED|95.26|0.74|1.07||Following two interim analyses, a two-tailed P value of less than 0.047 was considered to indicate statistical significance.|Other (Log-binomial regression model)|||||1.07|0.74|0.19
91626224|NCT04539262|183144705|SUPERIORITY||Least Square Mean Difference by Day 7|-0.66|STANDARD_ERROR_OF_MEAN|0.4||0.1117|TWO_SIDED|95.0|-1.49|0.16||Least square (LS) Mean, Standard Error (SE), 95% CI and p-value were from Analysis of covariance (ANCOVA) with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.49|0.1117
91626225|NCT04539262|183144705|SUPERIORITY||LS Mean Difference by Day 7|-0.35|STANDARD_ERROR_OF_MEAN|0.4||0.3793|TWO_SIDED|95.0|-1.16|0.46||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.46|-1.16|0.3793
91626226|NCT04539262|183144705|SUPERIORITY||LS Mean Difference by Day 7|-0.24|STANDARD_ERROR_OF_MEAN|0.37||0.5248|TWO_SIDED|95.0|-1.0|0.52||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate|ANCOVA|||||0.52|-1.00|0.5248
91626227|NCT04539262|183144705|SUPERIORITY||LS Mean Difference by Day 7|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.461|TWO_SIDED|95.0|-0.94|0.44|||ANCOVA|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate||||0.44|-0.94|0.4610
91626228|NCT04539262|183144705|SUPERIORITY||LS Mean Difference by Day 7|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5006|TWO_SIDED|95.0|-0.4|0.81||LS Mean (SE), 95% CI and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.81|-0.40|0.5006
91626229|NCT04539262|183144706|SUPERIORITY||LS Mean Difference by Day 7|0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3417|TWO_SIDED|95.0|-0.37|1.02||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.02|-0.37|0.3417
91626230|NCT04539262|183144706|SUPERIORITY||LS Mean Difference by Day 7|0.49|STANDARD_ERROR_OF_MEAN|0.35||0.1803|TWO_SIDED|95.0|-0.24|1.21||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.21|-0.24|0.1803
91626231|NCT04539262|183144706|SUPERIORITY||LS Mean Difference by Day 7|-0.55|STANDARD_ERROR_OF_MEAN|0.35||0.1233|TWO_SIDED|95.0|-1.27|0.16||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.27|0.1233
91626232|NCT04539262|183144706|SUPERIORITY||LS Mean Difference by Day 7|0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8203|TWO_SIDED|95.0|-0.64|0.8||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.80|-0.64|0.8203
91626233|NCT04539262|183144706|SUPERIORITY||LS Mean Difference by Day 7|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.6458|TWO_SIDED|95.0|-0.65|0.41||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.41|-0.65|0.6458
91626234|NCT04539262|183144707|SUPERIORITY||LS Mean Difference by Day 7|-0.22|STANDARD_ERROR_OF_MEAN|0.4||0.5951|TWO_SIDED|95.0|-1.05|0.61||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.61|-1.05|0.5951
91626235|NCT04539262|183144707|SUPERIORITY|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|LS Mean Difference by Day 7|-0.71|STANDARD_ERROR_OF_MEAN|0.4||0.0872|TWO_SIDED|95.0|-1.54|0.11|||ANCOVA|||||0.11|-1.54|0.0872
91663111|NCT01175135|183221532|OTHER||Least Squares (LS) Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|2.683||0.2053|TWO_SIDED|80.0|-5.66|1.24||Reported p-value was 1-sided.|Mixed Models Analysis|||Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.24|-5.66|0.2053
91663112|NCT01175135|183221532|OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|2.698||0.4024|TWO_SIDED|80.0|-4.14|2.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||2.80|-4.14|0.4024
91663113|NCT01175135|183221532|OTHER||LS Mean Difference|-8.24|STANDARD_ERROR_OF_MEAN|3.453||0.009|TWO_SIDED|80.0|-12.68|-3.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-3.80|-12.68|0.0090
91663114|NCT01175135|183221533|OTHER||Difference in Proportion|-0.03|||||TWO_SIDED|80.0|-0.07|0.01|||||The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.|||0.01|-0.07|
91714035|NCT00810069|183319696|SUPERIORITY_OR_OTHER||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.33|0.06||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.06|-0.33|0.181
91626236|NCT04539262|183144707|SUPERIORITY||LS Mean Difference by Day 7|-0.19|STANDARD_ERROR_OF_MEAN|0.36||0.6031|TWO_SIDED|95.0|-0.94|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.94|0.6031
91626237|NCT04539262|183144707|SUPERIORITY||LS Mean Difference by Day 7|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.7578|TWO_SIDED|95.0|-0.64|0.87||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.87|-0.64|0.7578
91626238|NCT04539262|183144707|SUPERIORITY||LS Mean Difference by Day 7|0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8846|TWO_SIDED|95.0|-0.48|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.48|0.8846
91626239|NCT02980692|183144740|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
91626240|NCT02980692|183144740|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
91626241|NCT02980692|183144740|SUPERIORITY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||||||0.0088
91626242|NCT02980692|183144740|SUPERIORITY|||||||0.0041|||||||Cochran-Mantel-Haenszel|||||||0.0041
91626243|NCT02980692|183144741|SUPERIORITY||% response rate|92.54|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|86.24|98.83||||||||98.83|86.24|
91626244|NCT02980692|183144741|SUPERIORITY||% response rate|89.06|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|81.42|96.71||||||||96.71|81.42|
91626245|NCT02980692|183144741|SUPERIORITY||% response rate|86.67|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|78.07|95.27||||||||95.27|78.07|
91626246|NCT02980692|183144741|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
91626247|NCT02980692|183144741|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
91626248|NCT02980692|183144742|SUPERIORITY||% response rate|79.1|STANDARD_ERROR_OF_MEAN|4.97|||TWO_SIDED|95.0|69.37|88.84||||||||88.84|69.37|
91663115|NCT01175135|183221533|OTHER||Difference in Proportion|0.04|||||TWO_SIDED|80.0|-0.02|0.1|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||0.10|-0.02|
91663116|NCT01175135|183221533|OTHER||Difference in Proportion|-0.04|||||TWO_SIDED|80.0|-0.08|0.0|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||-0.00|-0.08|
91663117|NCT01175135|183221534|OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.845||0.3144|TWO_SIDED|80.0|-1.5|0.68||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.68|-1.50|0.3144
91663118|NCT01175135|183221534|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.854||0.57|TWO_SIDED|80.0|-0.95|1.25||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.25|-0.95|0.5700
91663119|NCT01175135|183221534|OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.093||0.0034|TWO_SIDED|80.0|-4.4|-1.59||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.59|-4.40|0.0034
91663120|NCT01175135|183221534|OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.73||0.0942|TWO_SIDED|80.0|-1.9|-0.02||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.02|-1.90|0.0942
91663121|NCT01175135|183221534|OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.735||0.203|TWO_SIDED|80.0|-1.56|0.33||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.33|-1.56|0.2030
91663122|NCT01175135|183221534|OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.944||0.0907|TWO_SIDED|80.0|-2.48|-0.05||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.05|-2.48|0.0907
91663123|NCT01175135|183221534|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|1.33||0.2904|TWO_SIDED|80.0|-2.45|0.97||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.97|-2.45|0.2904
91663124|NCT01175135|183221534|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.339||0.471|TWO_SIDED|80.0|-1.82|1.62||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.62|-1.82|0.4710
91663125|NCT01175135|183221534|OTHER||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.718||0.0172|TWO_SIDED|80.0|-5.86|-1.45||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.45|-5.86|0.0172
91663126|NCT01175135|183221535|OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.154||0.197|TWO_SIDED|80.0|-0.33|0.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.07|-0.33|0.1970
91792036|NCT01857310|183461826|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-1.5|2.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||2.0|-1.5|
91482183|NCT00491556|182838216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.47|STANDARD_DEVIATION|6.81|<|0.0001|TWO_SIDED|95.0|9.52|15.41|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||15.41|9.52|< 0.0001
91482184|NCT00491556|182838217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_DEVIATION|5.12||0.0808|TWO_SIDED|95.0|-4.17|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.26|-4.17|0.0808
91525289|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-14.15|||<|0.001|TWO_SIDED|95.0|-17.77|-10.54|||Mixed Models Analysis|||||-10.54|-17.77|<0.001
91663127|NCT01175135|183221535|OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.154||0.3835|TWO_SIDED|80.0|-0.24|0.15||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.15|-0.24|0.3835
91663128|NCT01175135|183221535|OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.199||0.0395|TWO_SIDED|80.0|-0.61|-0.1||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.10|-0.61|0.0395
91663129|NCT01175135|183221536|OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.863||0.1999|TWO_SIDED|80.0|-1.84|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.84|0.1999
91663130|NCT01175135|183221536|OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.87||0.3399|TWO_SIDED|80.0|-1.48|0.76||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.76|-1.48|0.3399
91626249|NCT02980692|183144742|SUPERIORITY||% response rate|75.0|STANDARD_ERROR_OF_MEAN|5.41|||TWO_SIDED|95.0|64.39|85.61||||||||85.61|64.39|
91626250|NCT02980692|183144742|SUPERIORITY||% response rate|72.13|STANDARD_ERROR_OF_MEAN|5.74|||TWO_SIDED|95.0|60.88|83.38||||||||83.38|60.88|
91663131|NCT01175135|183221536|OTHER||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|1.117||0.01|TWO_SIDED|80.0|-4.06|-1.18||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.18|-4.06|0.0100
91663132|NCT01175135|183221536|OTHER||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.778||0.1625|TWO_SIDED|80.0|-1.77|0.23||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.23|-1.77|0.1625
91792037|NCT01857310|183461826|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.75|1.49|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||1.49|0.75|
91626251|NCT02980692|183144742|SUPERIORITY||% response rate|68.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|57.44|78.56||||||||78.56|57.44|
91626252|NCT02980692|183144742|SUPERIORITY||% response rate|62.67|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|51.72|73.61||||||||73.61|51.72|
91626253|NCT02980692|183144743|SUPERIORITY||% response rate|58.21|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|46.4|70.02||||||||70.02|46.40|
91626254|NCT02980692|183144743|SUPERIORITY||% response rate|48.44|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|36.19|60.68||||||||60.68|36.19|
91626255|NCT02980692|183144743|SUPERIORITY||% response rate|39.34|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|27.09|51.6||||||||51.60|27.09|
91626256|NCT02980692|183144743|SUPERIORITY||% response rate|40.0|STANDARD_ERROR_OF_MEAN|5.66|||TWO_SIDED|95.0|28.91|51.09||||||||51.09|28.91|
91626257|NCT02980692|183144743|SUPERIORITY||% response rate|37.33|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|26.39|48.28||||||||48.28|26.39|
91626258|NCT02980692|183144744|SUPERIORITY|||||||0.085|||||||Cochran-Mantel-Haenszel|||||||0.0850
91626259|NCT02980692|183144744|SUPERIORITY|||||||0.0234|||||||Cochran-Mantel-Haenszel|||||||0.0234
91792038|NCT01857310|183461827|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational age will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.5|
91792039|NCT01857310|183461828|SUPERIORITY||Risk Difference (RD)|-64.7|||||TWO_SIDED|95.0|-156.0|26.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Birth weight will be compared using two sided tests conducted at the 0.05 level."||26.4|-156|
91525290|NCT04867785|182925765|SUPERIORITY||LSMean Difference|-15.22|||<|0.001|TWO_SIDED|95.0|-18.36|-12.07|||Mixed Models Analysis|||||-12.07|-18.36|<0.001
91525291|NCT00981474|182925786|SUPERIORITY||Risk Ratio (RR)|0.96||||0.752|TWO_SIDED|95.0|0.82|1.121|||Chi-squared|||||1.121|.82|.752
91626260|NCT02980692|183144744|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||0.0140
91626261|NCT02980692|183144744|SUPERIORITY|||||||0.0731|||||||Cochran-Mantel-Haenszel|||||||0.0731
91626262|NCT02980692|183144745|SUPERIORITY||Mean Difference (Net)|-12.3|STANDARD_DEVIATION|11.47|||TWO_SIDED|||||||||||||
91626263|NCT02980692|183144745|SUPERIORITY||Mean Difference (Net)|-13.7|STANDARD_DEVIATION|11.92|||TWO_SIDED|||||||||||||
91626264|NCT02980692|183144745|SUPERIORITY||Mean Difference (Net)|-16.0|STANDARD_DEVIATION|12.83|||TWO_SIDED|||||||||||||
91626265|NCT02980692|183144745|SUPERIORITY||Mean Difference (Net)|-14.0|STANDARD_DEVIATION|10.65|||TWO_SIDED|||||||||||||
91626266|NCT02980692|183144745|SUPERIORITY||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|12.02|||TWO_SIDED|||||||||||||
91626267|NCT02980692|183144746|SUPERIORITY|||||||0.0111|||||||Cochran-Mantel-Haenszel|||||||0.0111
91626268|NCT02980692|183144746|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|||||||0.0774
91626269|NCT02980692|183144746|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.0190
91626270|NCT02980692|183144746|SUPERIORITY|||||||0.1282|||||||Cochran-Mantel-Haenszel|||||||0.1282
91626271|NCT02980692|183144747|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||||||
91626272|NCT02980692|183144747|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|7.07|||TWO_SIDED|||||||||||||
91626273|NCT02980692|183144747|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|7.62|||TWO_SIDED|||||||||||||
91626274|NCT02980692|183144747|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||||||
91626275|NCT02980692|183144747|SUPERIORITY||Mean Difference (Net)|-9.0|STANDARD_DEVIATION|8.8|||TWO_SIDED|||||||||||||
91626276|NCT02980692|183144748|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
91626277|NCT02980692|183144748|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
91626278|NCT02980692|183144748|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
91626279|NCT02980692|183144748|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
91663133|NCT01175135|183221536|OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.783||0.2354|TWO_SIDED|80.0|-1.57|0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.44|-1.57|0.2354
91714036|NCT00810069|183319696|SUPERIORITY_OR_OTHER||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.994|TWO_SIDED|95.0|-0.2|0.2||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.20|-0.20|0.994
91714037|NCT00810069|183319697|SUPERIORITY_OR_OTHER||LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||-0.25|-0.98|0.001
91482185|NCT00491556|182838218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_DEVIATION|13.83||0.0005|TWO_SIDED|95.0|5.72|17.69|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.69|5.72|0.0005
91714038|NCT00810069|183319697|SUPERIORITY_OR_OTHER||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|95.0|-0.87|-0.12||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.12|-0.87|0.010
91714039|NCT00810069|183319697|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.445|TWO_SIDED|95.0|-0.55|0.24||P-value for Week 10: analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||0.24|-0.55|0.445
91482186|NCT00491556|182838219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|14.12||0.9198|TWO_SIDED|95.0|-6.41|5.81|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.81|-6.41|0.9198
91482187|NCT00491556|182838220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|STANDARD_DEVIATION|2.97|<|0.0001|TWO_SIDED|95.0|2.4|4.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||4.97|2.40|< 0.0001
91525292|NCT00981474|182925787|SUPERIORITY||Risk Ratio (RR)|0.55||||0.053|TWO_SIDED|95.0|0.32|0.93|||Chi-squared|||||.93|.32|.053
91525293|NCT00981474|182925788|SUPERIORITY||Risk Ratio (RR)|0.454||||0.149|TWO_SIDED|95.0|0.18|1.17|||Chi-squared|||||1.17|.18|.149
91626280|NCT02980692|183144749|SUPERIORITY||Mean Difference (Net)|-40.0|STANDARD_DEVIATION|17.38|||TWO_SIDED|||||||||||||
91626281|NCT02980692|183144749|SUPERIORITY||Mean Difference (Net)|-44.3|STANDARD_DEVIATION|19.73|||TWO_SIDED|||||||||||||
91626282|NCT02980692|183144749|SUPERIORITY||Mean Difference (Net)|-45.3|STANDARD_DEVIATION|19.84|||TWO_SIDED|||||||||||||
91626283|NCT02980692|183144749|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|19.18|||TWO_SIDED|||||||||||||
91626284|NCT02980692|183144749|SUPERIORITY||Mean Difference (Net)|-42.0|STANDARD_DEVIATION|20.41|||TWO_SIDED|||||||||||||
91626285|NCT02980692|183144750|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
91626286|NCT02980692|183144750|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
91626287|NCT02980692|183144750|SUPERIORITY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
91626288|NCT02980692|183144750|SUPERIORITY|||||||0.0167|||||||Cochran-Mantel-Haenszel|||||||0.0167
91626289|NCT02980692|183144751|SUPERIORITY||Mean Difference (Net)|-42.2|STANDARD_DEVIATION|22.74|||TWO_SIDED|||||||||||||
91626290|NCT02980692|183144751|SUPERIORITY||Mean Difference (Net)|-43.8|STANDARD_DEVIATION|24.01|||TWO_SIDED|||||||||||||
91525294|NCT00981474|182925789|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.144|TWO_SIDED|95.0|0.3|1.13|||Chi-squared|||||1.13|.30|.144
91626291|NCT02980692|183144751|SUPERIORITY||Mean Difference (Net)|-38.4|STANDARD_DEVIATION|27.9|||TWO_SIDED|||||||||||||
91626292|NCT02980692|183144751|SUPERIORITY||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|24.65|||TWO_SIDED|||||||||||||
91626293|NCT02980692|183144751|SUPERIORITY||Mean Difference (Net)|-40.5|STANDARD_DEVIATION|28.13|||TWO_SIDED|||||||||||||
91626294|NCT02980692|183144752|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
91626295|NCT02980692|183144752|SUPERIORITY|||||||0.0055|||||||Cochran-Mantel-Haenszel|||||||0.0055
91626296|NCT02980692|183144752|SUPERIORITY|||||||0.0039|||||||Cochran-Mantel-Haenszel|||||||0.0039
91626297|NCT02980692|183144752|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
91626298|NCT02980692|183144753|SUPERIORITY||Mean Difference (Net)|-40.7|STANDARD_DEVIATION|21.59|||TWO_SIDED|||||||||||||
91626299|NCT02980692|183144753|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|25.67|||TWO_SIDED|||||||||||||
91626300|NCT02980692|183144753|SUPERIORITY||Mean Difference (Net)|-38.0|STANDARD_DEVIATION|29.26|||TWO_SIDED|||||||||||||
91626301|NCT02980692|183144753|SUPERIORITY||Mean Difference (Net)|-37.6|STANDARD_DEVIATION|26.63|||TWO_SIDED|||||||||||||
91626302|NCT02980692|183144753|SUPERIORITY||Mean Difference (Net)|-41.0|STANDARD_DEVIATION|29.83|||TWO_SIDED|||||||||||||
91626303|NCT02980692|183144754|SUPERIORITY|||||||0.0987|||||||Cochran-Mantel-Haenszel|||||||0.0987
91626304|NCT02980692|183144754|SUPERIORITY|||||||0.036|||||||Cochran-Mantel-Haenszel|||||||0.0360
91626305|NCT02980692|183144754|SUPERIORITY|||||||0.0346|||||||Cochran-Mantel-Haenszel|||||||0.0346
91626306|NCT02980692|183144754|SUPERIORITY|||||||0.4442|||||||Cochran-Mantel-Haenszel|||||||0.4442
91626307|NCT02980692|183144755|SUPERIORITY||Mean Difference (Net)|-0.4869|STANDARD_DEVIATION|0.52093|||TWO_SIDED|||||||||||||
91626308|NCT02980692|183144755|SUPERIORITY||Mean Difference (Net)|-0.543|STANDARD_DEVIATION|0.59145|||TWO_SIDED|||||||||||||
91626309|NCT02980692|183144755|SUPERIORITY||Mean Difference (Net)|-0.4857|STANDARD_DEVIATION|0.56968|||TWO_SIDED|||||||||||||
91626310|NCT02980692|183144755|SUPERIORITY||Mean Difference (Net)|-0.4583|STANDARD_DEVIATION|0.52285|||TWO_SIDED|||||||||||||
91626311|NCT02980692|183144755|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.54013|||TWO_SIDED|||||||||||||
91714040|NCT00810069|183319697|SUPERIORITY_OR_OTHER||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.169|TWO_SIDED|95.0|-0.71|0.12||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.12|-0.71|0.169
91525295|NCT00981474|182925790|SUPERIORITY||Risk Ratio (RR)|0.724||||0.439|TWO_SIDED|95.0|0.37|1.41|||Chi-squared|||||1.41|.37|.439
91626312|NCT02980692|183144756|SUPERIORITY|||||||0.0064|||||||Cochran-Mantel-Haenszel|||||||0.0064
91626313|NCT02980692|183144756|SUPERIORITY|||||||0.0516|||||||Cochran-Mantel-Haenszel|||||||0.0516
91626314|NCT02980692|183144756|SUPERIORITY|||||||0.0114|||||||Cochran-Mantel-Haenszel|||||||0.0114
91626315|NCT02980692|183144756|SUPERIORITY|||||||0.082|||||||Cochran-Mantel-Haenszel|||||||0.0820
91626316|NCT02980692|183144757|SUPERIORITY||Mean Difference (Net)|-3.43|STANDARD_DEVIATION|12.506|||TWO_SIDED|||||||||||||
91626317|NCT02980692|183144757|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_DEVIATION|10.77|||TWO_SIDED|||||||||||||
91626318|NCT02980692|183144757|SUPERIORITY||Mean Difference (Net)|-6.05|STANDARD_DEVIATION|19.004|||TWO_SIDED|||||||||||||
91626319|NCT02980692|183144757|SUPERIORITY||Mean Difference (Net)|-4.61|STANDARD_DEVIATION|9.508|||TWO_SIDED|||||||||||||
91626320|NCT02980692|183144757|SUPERIORITY||Mean Difference (Net)|-6.75|STANDARD_DEVIATION|19.649|||TWO_SIDED|||||||||||||
91626321|NCT02980692|183144758|SUPERIORITY|||||||0.0351|||||||Cochran-Mantel-Haenszel|||||||0.0351
91626322|NCT02980692|183144758|SUPERIORITY|||||||0.0876|||||||Cochran-Mantel-Haenszel|||||||0.0876
91626323|NCT02980692|183144758|SUPERIORITY|||||||0.0269|||||||Cochran-Mantel-Haenszel|||||||0.0269
91626324|NCT02980692|183144758|SUPERIORITY|||||||0.0185|||||||Cochran-Mantel-Haenszel|||||||0.0185
91626325|NCT02980692|183144759|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|19.58|||TWO_SIDED|||||||||||||
91626326|NCT02980692|183144759|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|15.26|||TWO_SIDED|||||||||||||
91626327|NCT02980692|183144759|SUPERIORITY||Median Difference (Net)|-8.9|STANDARD_DEVIATION|20.48|||TWO_SIDED|||||||||||||
91626328|NCT02980692|183144759|SUPERIORITY||Mean Difference (Net)|-9.7|STANDARD_DEVIATION|19.02|||TWO_SIDED|||||||||||||
91626329|NCT02980692|183144759|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||||||
91626330|NCT02980692|183144760|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
91626331|NCT02980692|183144760|SUPERIORITY||Proportion with Adjustment of Background|1.3|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|0.0|3.83||||||||3.83|0.00|
91626332|NCT02980692|183144760|SUPERIORITY||Proportion with Adjustment of Background|2.56|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|0.0|6.07||||||||6.07|0.00|
91626333|NCT02980692|183144760|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
91626334|NCT02980692|183144761|SUPERIORITY||% response rate|85.07|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|76.54|93.61||||||||93.61|76.54|
91626335|NCT02980692|183144761|SUPERIORITY||% response rate|81.25|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|95.0|71.69|90.81||||||||90.81|71.69|
91626336|NCT02980692|183144761|SUPERIORITY||% response rate|76.27|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|95.0|65.42|87.13||||||||87.13|65.42|
91626337|NCT02980692|183144761|SUPERIORITY||% response rate|71.05|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|60.86|81.25||||||||81.25|60.86|
91626338|NCT02980692|183144761|SUPERIORITY||% response rate|65.33|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|54.56|76.1||||||||76.10|54.56|
91626339|NCT02980692|183144762|SUPERIORITY||% response rate|56.92|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|95.0|44.88|68.96||||||||68.96|44.88|
91626340|NCT02980692|183144762|SUPERIORITY||% response rate|64.41|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|52.19|76.62||||||||76.62|52.19|
91626341|NCT02980692|183144762|SUPERIORITY||% response rate|45.0|STANDARD_ERROR_OF_MEAN|6.42|||TWO_SIDED|95.0|32.41|57.59||||||||57.59|32.41|
91626342|NCT02980692|183144762|SUPERIORITY||% response rate|47.06|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|35.2|58.92||||||||58.92|35.20|
91626343|NCT02980692|183144762|SUPERIORITY||% response rate|42.03|STANDARD_ERROR_OF_MEAN|5.94|||TWO_SIDED|95.0|30.38|53.68||||||||53.68|30.38|
91626344|NCT02980692|183144763|SUPERIORITY|||||||0.7081|||||||Cochran-Mantel-Haenszel|||||||0.7081
91626345|NCT02980692|183144763|SUPERIORITY|||||||0.9244|||||||Cochran-Mantel-Haenszel|||||||0.9244
91626346|NCT02980692|183144763|SUPERIORITY|||||||0.5365|||||||Cochran-Mantel-Haenszel|||||||0.5365
91626347|NCT02980692|183144763|SUPERIORITY|||||||0.2925|||||||Cochran-Mantel-Haenszel|||||||0.2925
91626348|NCT02980692|183144764|SUPERIORITY||Mean Difference (Net)|-14.453|STANDARD_DEVIATION|31.9358|||TWO_SIDED|||||||||||||
91626349|NCT02980692|183144764|SUPERIORITY||Mean Difference (Net)|-18.883|STANDARD_DEVIATION|57.1147|||TWO_SIDED|||||||||||||
91626350|NCT02980692|183144764|SUPERIORITY||Mean Difference (Net)|-27.084|STANDARD_DEVIATION|76.2272|||TWO_SIDED|||||||||||||
91626351|NCT02980692|183144764|SUPERIORITY||Mean Difference (Net)|-26.173|STANDARD_DEVIATION|87.5367|||TWO_SIDED|||||||||||||
91626352|NCT02980692|183144764|SUPERIORITY||Mean Difference (Net)|-50.399|STANDARD_DEVIATION|141.677|||TWO_SIDED|||||||||||||
91626353|NCT02980692|183144765|SUPERIORITY|||||||0.0203|||||||Cochran-Mantel-Haenszel|||||||0.0203
91626354|NCT02980692|183144765|SUPERIORITY|||||||0.5194|||||||Cochran-Mantel-Haenszel|||||||0.5194
91626355|NCT02980692|183144765|SUPERIORITY|||||||0.0599|||||||Cochran-Mantel-Haenszel|||||||0.0599
91626356|NCT02980692|183144765|SUPERIORITY|||||||0.122|||||||Cochran-Mantel-Haenszel|||||||0.1220
91626357|NCT02980692|183144766|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|1.86|||TWO_SIDED|||||||||||||
91626358|NCT02980692|183144766|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|1.56|||TWO_SIDED|||||||||||||
91626359|NCT02980692|183144766|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
91626360|NCT02980692|183144766|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.75|||TWO_SIDED|||||||||||||
91626361|NCT02980692|183144766|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.82|||TWO_SIDED|||||||||||||
91626362|NCT00792701|183144770|OTHER|Correlation|Correlation Coefficient|0.39||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
91626363|NCT00792701|183144773|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient|0.39||||0.0003|TWO_SIDED||||||Chi-squared|||Comparing RRM1 levels and ERCC1 levels between all patients.||||.0003
91482188|NCT00491556|182838221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_DEVIATION|2.54||0.0215|TWO_SIDED|95.0|-2.41|-0.21|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.21|-2.41|0.0215
91482189|NCT00734747|182838225|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
91482190|NCT05063318|182838260|SUPERIORITY||Least-squares geometric mean ratio|272.73|||||TWO_SIDED|90.0|213.22|348.86|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||348.86|213.22|
91482191|NCT05063318|182838261|SUPERIORITY||Least-squares geometric mean ratio|236.73|||||TWO_SIDED|90.0|177.35|316.0|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||316.00|177.35|
91482192|NCT05063318|182838262|SUPERIORITY||least-squares geometric mean ratio.|115.51|||||TWO_SIDED|90.0|100.07|133.33|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||133.33|100.07|
91482193|NCT05063318|182838263|SUPERIORITY||Least-squares geometric mean ratio.|217.57|||||TWO_SIDED|90.0|151.81|311.82|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence (TR or RT) as fixed effects, and patient (sequence) as a random effect.||||311.82|151.81|
91482194|NCT05063318|182838264|SUPERIORITY||Least-squares geometric mean ratio|36.67|||||TWO_SIDED|90.0|28.66|46.9|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||46.9|28.66|
91626364|NCT01057862|183144820|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|6.0|STANDARD_DEVIATION|9.35|||TWO_SIDED||||||||The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
91663134|NCT01175135|183221536|OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.002||0.2161|TWO_SIDED|80.0|-2.08|0.5||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.50|-2.08|0.2161
91663135|NCT01175135|183221536|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.627||0.248|TWO_SIDED|80.0|-1.23|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.23|0.2480
91482195|NCT05063318|182838265|SUPERIORITY||Least-squares geometric mean ratio|99.89|||||TWO_SIDED|90.0|65.76|151.74|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||151.74|65.76|
91482196|NCT00920829|182838295|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|||A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.||||0.724
91482197|NCT00920829|182838295|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.||||0.023
91482198|NCT02237911|182838298|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.071|TWO_SIDED|98.3|-4.9|0.7|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.7|-4.9|0.071
91482199|NCT02237911|182838298|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.074|TWO_SIDED|98.3|-5.0|0.7|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||0.7|-5.0|0.074
91482200|NCT02237911|182838298|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|98.3|-2.7|2.9|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||2.9|-2.7|0.930
91482201|NCT02237911|182838298|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.491|TWO_SIDED|98.3|-3.7|2.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||2.0|-3.7|0.491
91482202|NCT02237911|182838298|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.021|TWO_SIDED|98.3|-4.5|0.1|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.1|-4.5|0.021
91482203|NCT02237911|182838298|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.179|TWO_SIDED|98.3|-3.6|1.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||1.0|-3.6|0.179
91482204|NCT02237911|182838299|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.0001|TWO_SIDED|98.3|0.1|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.1|<0.0001
91482205|NCT02237911|182838299|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.012|TWO_SIDED|98.3|0.01|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.01|0.012
91663136|NCT01175135|183221536|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.632||0.4345|TWO_SIDED|80.0|-0.92|0.71||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.71|-0.92|0.4345
91714041|NCT00810069|183319697|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.393|TWO_SIDED|95.0|-0.63|0.25||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.25|-0.63|0.393
91525296|NCT00981474|182925791|SUPERIORITY||Risk Ratio (RR)|0.872||||0.311|TWO_SIDED|95.0|0.69|1.11|||Chi-squared|||||1.11|.69|.311
91525297|NCT00981474|182925792|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.005|1.18|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.18|.005|.103
91626365|NCT01057862|183144821|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.45|||TWO_SIDED||||||||The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
91626366|NCT03363165|183144827|SUPERIORITY||Mean Difference (Final Values)|-13.54||||0.7586|ONE_SIDED|90.0|-38.52||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-38.52|0.7586
91626367|NCT03363165|183144828|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.0298|ONE_SIDED|90.0|0.78||||ANCOVA|Adjusted for baseline maximal treadmill walking time, age, race, former smoker|||||0.78|0.0298
91626368|NCT03363165|183144829|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.4019|ONE_SIDED|90.0|-3.1||||ANCOVA|Adjusted for baseline perfusion, age, race, former smoker.|||||-3.10|0.4019
91626369|NCT03363165|183144830|SUPERIORITY||Mean Difference (Final Values)|8.28||||0.208|ONE_SIDED|90.0|-5.37||||ANCOVA|Adjusted for baseline muscle measure, age, race, former smoker.|||||-5.37|0.2080
91626370|NCT03363165|183144831|SUPERIORITY||Mean Difference (Final Values)|2.02||||0.398|ONE_SIDED|90.0|-8.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker|||||-8.11|0.3980
91626371|NCT03363165|183144832|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.7852|ONE_SIDED|90.0|-14.5||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-14.50|0.7852
91626372|NCT03363165|183144833|SUPERIORITY||Mean Difference (Final Values)|-5.14||||0.8414|ONE_SIDED|90.0|-11.76||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-11.76|0.8414
91626373|NCT03363165|183144834|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5912|ONE_SIDED|90.0|-14.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker.|||||-14.11|0.5912
91626374|NCT03363165|183144835|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5442|ONE_SIDED|90.0|-25.47||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-25.47|0.5442
91626375|NCT03363165|183144836|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6603|ONE_SIDED|90.0|-2.11|||Adjusted for baseline pain-free treadmill walking time, age, race, former smoker.|ANCOVA||||||-2.11|0.6603
91626376|NCT03363165|183144837|SUPERIORITY||Mean Difference (Final Values)|-2.78||||0.5647|ONE_SIDED|90.0|-24.99||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-24.99|0.5647
91626377|NCT02052141|183144862|SUPERIORITY||Mean difference|-0.4|STANDARD_DEVIATION|0.58||0.03|TWO_SIDED|90.0|-0.71|-0.1|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.10|-0.71|0.03
91626378|NCT02052141|183144863|SUPERIORITY||Mean difference|-0.7|STANDARD_DEVIATION|1.06||0.05|TWO_SIDED|90.0|-1.2|-0.11|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.11|-1.20|0.05
91626379|NCT02052141|183144864|SUPERIORITY||Mean difference|-1.9|STANDARD_DEVIATION|2.82||0.04|TWO_SIDED|90.0|-3.31|-0.38|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.38|-3.31|0.04
91626380|NCT02052141|183144865|SUPERIORITY||Mean difference|-0.2|STANDARD_DEVIATION|0.37||0.07|TWO_SIDED|90.0|-0.41|-0.03|||Paired t-test||The difference between treatment B over treatment A was estimated|||-0.03|-0.41|0.07
91626381|NCT03000686|183144876|OTHER||Median Difference (Net)|0.021|STANDARD_DEVIATION|1.1339|||TWO_SIDED|95.0|-2.249|2.295|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||2.295|-2.249|
91626382|NCT03000686|183144876|OTHER||Median Difference (Net)|-4.021|STANDARD_DEVIATION|2.5923|||TWO_SIDED|95.0|-9.168|1.146|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||1.146|-9.168|
91626383|NCT03000686|183144876|OTHER||Median Difference (Net)|-1.668|STANDARD_DEVIATION|4.4927|||TWO_SIDED|95.0|-10.576|7.231|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise|||7.231|-10.576|
91626384|NCT03000686|183144876|OTHER||Median Difference (Net)|-0.824|STANDARD_DEVIATION|1.6695|||TWO_SIDED|95.0|-4.142|2.506|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||2.506|-4.142|
91626385|NCT03000686|183144877|OTHER||Median Difference (Net)|-0.662|STANDARD_DEVIATION|2.1933|||TWO_SIDED|95.0|-5.037|3.815|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||3.815|-5.037|
91626386|NCT03000686|183144877|OTHER||Median Difference (Net)|-2.796|STANDARD_DEVIATION|3.4297|||TWO_SIDED|95.0|-9.729|4.027|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||4.027|-9.729|
91626387|NCT03000686|183144877|OTHER||Median Difference (Net)|-0.018|STANDARD_DEVIATION|4.145|||TWO_SIDED|95.0|-8.475|8.086|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start|||8.086|-8.475|
91482206|NCT02237911|182838299|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.005|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.005
91482207|NCT02237911|182838299|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.052|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.052
91482208|NCT02237911|182838299|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.015|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.015
91482209|NCT02237911|182838299|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.489|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.489
91663137|NCT01175135|183221536|OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.813||0.0346|TWO_SIDED|80.0|-2.53|-0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.44|-2.53|0.0346
91663138|NCT01175135|183221536|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.495||0.4685|TWO_SIDED|80.0|-0.68|0.6||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.60|-0.68|0.4685
91663139|NCT01175135|183221536|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.499||0.6214|TWO_SIDED|80.0|-0.49|0.8||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.80|-0.49|0.6214
91663140|NCT01175135|183221536|OTHER||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.641||0.0052|TWO_SIDED|80.0|-2.48|-0.84||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.84|-2.48|0.0052
91663141|NCT01175135|183221536|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.523||0.5894|TWO_SIDED|80.0|-0.55|0.79||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.79|-0.55|0.5894
91482210|NCT02237911|182838300|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.943|TWO_SIDED|95.0|-106.0|114.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||114|-106|0.943
91482211|NCT02237911|182838300|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.814|TWO_SIDED|95.0|-112.0|142.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||142|-112|0.814
91525298|NCT00981474|182925793|SUPERIORITY||Risk Ratio (RR)|1.102||||0.608|TWO_SIDED|95.0|0.81|1.5|||Chi-squared|||||1.5|.81|.608
91525299|NCT00981474|182925794|SUPERIORITY||Risk Ratio (RR)|0.564||||0.541|TWO_SIDED|95.0|0.16|1.97|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.97|.16|.541
91482212|NCT02237911|182838300|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.787|TWO_SIDED|95.0|-125.0|95.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||95|-125|0.787
91482213|NCT02237911|182838300|SUPERIORITY||Mean Difference (Final Values)|-36.0||||0.581|TWO_SIDED|95.0|-164.0|92.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||92|-164|0.581
91482214|NCT02237911|182838300|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.676|TWO_SIDED|95.0|-71.0|109.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||109|-71|0.676
91482215|NCT02237911|182838300|SUPERIORITY||Mean Difference (Final Values)|51.0||||0.33|TWO_SIDED|95.0|-52.0|154.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||154|-52|0.330
91525300|NCT00981474|182925795|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.05|1.18|||Fisher Exact|Fisher exact test used due to small number of events.||||1.18|.05|.103
91525301|NCT00981474|182925796|SUPERIORITY||Risk Ratio (RR)|0.409||||0.129|TWO_SIDED|95.0|0.15|1.14|||Chi-squared|||||1.14|.15|.129
91525302|NCT02991482|182925797|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
91663142|NCT01175135|183221536|OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.526||0.8155|TWO_SIDED|80.0|-0.2|1.15||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.15|-0.20|0.8155
91714042|NCT00810069|183319697|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.51|TWO_SIDED|95.0|-0.61|0.3||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline scores and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.30|-0.61|0.510
91626388|NCT03000686|183144877|OTHER||Median Difference (Net)|-0.291|STANDARD_DEVIATION|2.3277|||TWO_SIDED|95.0|-4.96|4.386|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||4.386|-4.960|
91626389|NCT03000686|183144884|OTHER||Median Difference (Net)|-0.148|STANDARD_DEVIATION|0.5622|||TWO_SIDED|95.0|-1.264|0.973|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||0.973|-1.264|
91626390|NCT03000686|183144884|OTHER||Median Difference (Net)|-1.172|STANDARD_DEVIATION|2.072|||TWO_SIDED|95.0|-5.271|2.942|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||2.942|-5.271|
91626391|NCT03000686|183144884|OTHER||Median Difference (Net)|-0.169|STANDARD_DEVIATION|2.2351|||TWO_SIDED|95.0|-4.624|4.258|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.|||4.258|-4.624|
91626392|NCT03000686|183144884|OTHER||Median Difference (Net)|-0.367|STANDARD_DEVIATION|0.5649|||TWO_SIDED|95.0|-1.498|0.753|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.753|-1.498|
91626393|NCT03000686|183144885|OTHER||Median Difference (Net)|0.203|STANDARD_DEVIATION|0.8872|||TWO_SIDED|95.0|-1.578|1.968|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||1.968|-1.578|
91626394|NCT03000686|183144885|OTHER||Median Difference (Net)|3.76|STANDARD_DEVIATION|1.8799|||TWO_SIDED|95.0|-0.001|7.495|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||7.495|-0.001|
91626395|NCT03000686|183144885|OTHER||Median Difference (Net)|-1.029|STANDARD_DEVIATION|2.8146|||TWO_SIDED|95.0|-6.673|4.578|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.|||4.578|-6.673|
91626396|NCT03000686|183144885|OTHER||Median Difference (Net)|-0.873|STANDARD_DEVIATION|0.762|||TWO_SIDED|95.0|-2.38|0.669|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.669|-2.380|
91626397|NCT01525667|183144918|SUPERIORITY_OR_OTHER||Least Square Means (LSM) Difference|25.74|STANDARD_ERROR_OF_MEAN|8.94||0.0067|TWO_SIDED|95.0|7.61|43.86|||Mixed Models Analysis||LSM difference =LSM Low dose - LSM Placebo|||43.86|7.61|0.0067
91626398|NCT01525667|183144918|SUPERIORITY_OR_OTHER||Least Square Means (LSM) difference|14.93|STANDARD_ERROR_OF_MEAN|10.8||0.18|TWO_SIDED|95.0|-7.12|36.99|||Mixed Models Analysis||LSM difference= LSM High Dose - LSM Placebo|||36.99|-7.12|0.18
91626399|NCT01525667|183144919|SUPERIORITY_OR_OTHER||LSM Difference|18.03|STANDARD_ERROR_OF_MEAN|5.97||0.004|TWO_SIDED|95.0|6.03|30.02|||Mixed Models Analysis|||||30.02|6.03|0.004
91626400|NCT01525667|183144919|SUPERIORITY_OR_OTHER||LSM difference|9.23|STANDARD_ERROR_OF_MEAN|6.91||0.19|TWO_SIDED|95.0|-4.72|23.17|||Mixed Models Analysis|||||23.17|-4.72|0.19
91626401|NCT01525667|183144920|SUPERIORITY_OR_OTHER||LSM Difference|6.45|STANDARD_ERROR_OF_MEAN|4.64||0.19|TWO_SIDED|95.0|-3.5|16.41|||ANCOVA|||||16.41|-3.50|0.19
91792040|NCT01857310|183461829|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.6|
91626402|NCT01525667|183144920|SUPERIORITY_OR_OTHER||LSM difference|5.49|STANDARD_ERROR_OF_MEAN|4.56||0.25|TWO_SIDED|95.0|-4.29|15.26|||ANCOVA|||||15.26|-4.29|0.25
91626403|NCT01525667|183144921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.19||0.4|TWO_SIDED|95.0|-0.21|0.53|||Mixed Models Analysis|||||0.53|-0.21|0.4
91626404|NCT01525667|183144921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.2||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
91626405|NCT01525667|183144922|SUPERIORITY_OR_OTHER||LSM difference|16.81|STANDARD_ERROR_OF_MEAN|8.37||0.05|TWO_SIDED|95.0|0.16|33.47|||Mixed Models Analysis|||||33.47|0.16|0.05
91626406|NCT01525667|183144922|SUPERIORITY_OR_OTHER||LSM difference|10.7|STANDARD_ERROR_OF_MEAN|9.01||0.24|TWO_SIDED|95.0|-7.26|28.65|||Mixed Models Analysis|||||28.65|-7.26|0.24
91626407|NCT01112982|183144928|OTHER|||||||0.34|||||||t-test, 2 sided|||Presence of synovial pannus and the serum urate level.||||0.34
91626408|NCT01112982|183144930|OTHER|Spearman Correlation Coefficient||||||0.73|||||||t-test, 1 sided|||The Severity of Synovial Pannus and the Serum Urate level.||||0.73
91626409|NCT01112982|183144931|OTHER|correlation between severity of synovial pannus and the serum urate level.||||||0.73|||||||t-test, 1 sided|||||||0.73
91626410|NCT01112982|183144932|OTHER|||||||0.32||||||"The presence of synovial pannus in the index joint."|t-test, 1 sided|||||||0.32
91626411|NCT01112982|183144933|OTHER|Kappa Coefficient||||||0.09|||||||t-test, 2 sided|||The absence of erosive changes.||||0.09
91626412|NCT01112982|183144933|OTHER|the absence of Intraosseous Tophi.||||||0.33|||||||t-test, 2 sided|||||||0.33
91626413|NCT01112982|183144933|OTHER|The absence of Soft Tissue Tophi||||||0.09|||||||t-test, 2 sided|||||||0.09
91626414|NCT01112982|183144933|OTHER|The absence of Joint Effusion.||||||0.31|||||||t-test, 2 sided|||||||0.31
91626415|NCT01112982|183144933|OTHER|The absence of Bone Marrow Edema.||||||0.25|||||||t-test, 2 sided|||||||0.25
91626416|NCT01112982|183144933|OTHER|The absence of Soft Tissue Edema.||||||0.14|||||||t-test, 2 sided|||||||0.14
91626417|NCT01112982|183144934|OTHER|||||||0.32||||||"The Presence of synovial Pannus in the index joint."|t-test, 1 sided|||||||0.32
91626418|NCT01112982|183144934|OTHER|||||||0.99||||||"The Severity of Synovial Pannus in the index joint."|t-test, 1 sided|||||||0.99
91626419|NCT00753623|183144939|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91626420|NCT03332303|183144940|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Responders in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|90.0|-13.0|2.8||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||2.8|-13.0|
91482216|NCT03981822|182838324|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0048
91482217|NCT03981822|182838324|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0075
91482218|NCT03981822|182838325|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.||||0.3642
91482219|NCT03981822|182838325|SUPERIORITY|||||||0.0967||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0967
91482220|NCT03981822|182838325|SUPERIORITY|||||||0.0648||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0648
91482221|NCT03981822|182838325|SUPERIORITY|||||||0.1357||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.1357
91626421|NCT03332303|183144940|SUPERIORITY||% Difference|23.4|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
91626422|NCT03332303|183144940|SUPERIORITY||% Difference|28.7|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
91626423|NCT03332303|183144941|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Treatment Successes in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-2.0|||||TWO_SIDED|90.0|-10.7|6.7||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||6.7|-10.7|
91626424|NCT03332303|183144941|SUPERIORITY|To conclude superiority of the Test product over Placebo, the proportion of Treatment Successes in the Test product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|-0.8||||0.8068|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8068
91626425|NCT03332303|183144941|SUPERIORITY|To conclude superiority of the Reference product over Placebo, the proportion of Treatment Successes in the Reference product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|1.8||||0.8003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8003
91626426|NCT00871572|183144965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0296|TWO_SIDED|90.0|-1.64|-0.23|||Mixed Models Analysis|||||-0.23|-1.64|0.0296
91626427|NCT00871572|183144965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0418|TWO_SIDED|90.0|-1.37|-0.15|||Mixed Models Analysis|||||-0.15|-1.37|0.0418
91626428|NCT00871572|183144965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0514|TWO_SIDED|90.0|-1.41|-0.12|||Mixed Models Analysis|||||-0.12|-1.41|0.0514
91626429|NCT00871572|183144966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.2565|TWO_SIDED|95.0|-4.46|1.21|||Mixed Models Analysis|||||1.21|-4.46|0.2565
91626430|NCT00871572|183144966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.1245|TWO_SIDED|95.0|-4.25|0.53|||Mixed Models Analysis|||||0.53|-4.25|0.1245
91626431|NCT00871572|183144966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.0594|TWO_SIDED|95.0|-4.92|0.1|||Mixed Models Analysis|||||0.10|-4.92|0.0594
91626432|NCT00871572|183144967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-124.56||||0.4978|TWO_SIDED|95.0|-490.02|240.9|||ANCOVA|||||240.90|-490.02|0.4978
91626433|NCT00871572|183144967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-338.64||||0.0372|TWO_SIDED|95.0|-656.55|-20.72|||ANCOVA|||||-20.72|-656.55|0.0372
91626434|NCT00871572|183144967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-466.83||||0.0068|TWO_SIDED|95.0|-799.48|-134.18|||ANCOVA|||||-134.18|-799.48|0.0068
91626435|NCT00871572|183144968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.814|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.814
91626436|NCT00871572|183144968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.681|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.681
91626437|NCT00871572|183144968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.715|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||||0.5|-0.7|0.715
91626438|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.56||||0.0248|TWO_SIDED|95.0|-44.03|-3.09||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-3.09|-44.03|0.0248
91626439|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.28||||0.0002|TWO_SIDED|95.0|-53.08|-17.48||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-17.48|-53.08|0.0002
91626440|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.32|||<|0.0001|TWO_SIDED|95.0|-58.12|-20.53||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-20.53|-58.12|<0.0001
91626441|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42||||0.6513|TWO_SIDED|95.0|-34.66|21.82||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||21.82|-34.66|0.6513
91626442|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.5045|TWO_SIDED|95.0|-32.61|16.21||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||16.21|-32.61|0.5045
91626443|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2||||0.5774|TWO_SIDED|95.0|-32.9|18.49||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||18.49|-32.90|0.5774
91626444|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.81||||0.0045|TWO_SIDED|95.0|-60.1|-11.53||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-11.53|-60.10|0.0045
91626445|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.15||||0.0024|TWO_SIDED|95.0|-54.1|-12.21||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-12.21|-54.10|0.0024
91626446|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.87||||0.0011|TWO_SIDED|95.0|-59.98|-15.75||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-15.75|-59.98|0.0011
91626447|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.48||||0.0389|TWO_SIDED|95.0|-55.47|-1.49||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||-1.49|-55.47|0.0389
91626448|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.1896|TWO_SIDED|95.0|-39.24|7.94||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||7.94|-39.24|0.1896
91626449|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.56||||0.0729|TWO_SIDED|95.0|-47.28|2.16||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||2.16|-47.28|0.0729
91626450|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.78||||0.0041|TWO_SIDED|95.0|-74.79|-14.77||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-14.77|-74.79|0.0041
91626451|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.45|||<|0.0001|TWO_SIDED|95.0|-80.42|-28.48||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-28.48|-80.42|<0.0001
91626452|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.19||||0.0013|TWO_SIDED|95.0|-73.57|-18.81||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-18.81|-73.57|0.0013
91663143|NCT01175135|183221536|OTHER||LS Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.677||0.0069|TWO_SIDED|80.0|-2.55|-0.81||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.81|-2.55|0.0069
91663144|NCT01175135|183221537|OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.559||0.2727|TWO_SIDED|80.0|-1.06|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.06|0.2727
91792041|NCT01857310|183461829|SUPERIORITY||Risk Ratio (RR)|0.25|||||TWO_SIDED|95.0|0.03|2.24|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||2.24|0.03|
91626453|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.82||||0.0118|TWO_SIDED|95.0|-70.51|-9.13||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-9.13|-70.51|0.0118
91626454|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.8||||0.0016|TWO_SIDED|95.0|-70.42|-17.18||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-17.18|-70.42|0.0016
91626455|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.56||||0.0065|TWO_SIDED|95.0|-67.63|-11.48||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-11.48|-67.63|0.0065
91626456|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.88||||0.0154|TWO_SIDED|95.0|-66.43|-7.33||P-value is for Bedtime.|Mixed Models Analysis|||||-7.33|-66.43|0.0154
91626457|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.5||||0.0006|TWO_SIDED|95.0|-71.93|-21.07||P-value is for Bedtime.|Mixed Models Analysis|||||-21.07|-71.93|0.0006
91626458|NCT00871572|183144971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.07||||0.0029|TWO_SIDED|95.0|-69.13|-15.01||P-value is for Bedtime.|Mixed Models Analysis|||||-15.01|-69.13|0.0029
91626459|NCT00871572|183144972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.62||||0.3815|TWO_SIDED|95.0|-32.44|83.68|||Mixed Models Analysis|||||83.68|-32.44|0.3815
91626460|NCT00871572|183144972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.8315|TWO_SIDED|95.0|-45.12|55.93|||Mixed Models Analysis|||||55.93|-45.12|0.8315
91626461|NCT00871572|183144972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.25||||0.3658|TWO_SIDED|95.0|-28.93|77.44|||Mixed Models Analysis|||||77.44|-28.93|0.3658
91626462|NCT00871572|183144973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|55.06||||0.2131|TWO_SIDED|95.0|-32.24|142.37|||Mixed Models Analysis|||||142.37|-32.24|0.2131
91626463|NCT00871572|183144973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|89.68||||0.022|TWO_SIDED|95.0|13.27|166.1|||Mixed Models Analysis|||||166.10|13.27|0.0220
91626464|NCT00871572|183144973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.26||||0.0101|TWO_SIDED|95.0|26.29|188.22|||Mixed Models Analysis|||||188.22|26.29|0.0101
91626465|NCT00871572|183144974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.1596|TWO_SIDED|95.0|-0.75|4.49|||Mixed Models Analysis|||||4.49|-0.75|0.1596
91626466|NCT00871572|183144974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.0791|TWO_SIDED|95.0|-0.24|4.31|||Mixed Models Analysis|||||4.31|-0.24|0.0791
91626467|NCT00871572|183144974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.1564|TWO_SIDED|95.0|-0.67|4.1|||Mixed Models Analysis|||||4.10|-0.67|0.1564
91626468|NCT00871572|183144975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8018.51||||0.45|TWO_SIDED|95.0|-13104.14|29141.16|||ANCOVA|||||29141.16|-13104.14|0.4500
91626469|NCT00871572|183144975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5174.85||||0.5739|TWO_SIDED|95.0|-13158.65|23508.35|||ANCOVA|||||23508.35|-13158.65|0.5739
91663145|NCT01175135|183221537|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.562||0.4747|TWO_SIDED|80.0|-0.76|0.69||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.69|-0.76|0.4747
91626470|NCT00871572|183144975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18153.92||||0.0653|TWO_SIDED|95.0|-1188.23|37496.06|||ANCOVA|||||37496.06|-1188.23|0.0653
91626471|NCT00871572|183144976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18094.32||||0.6209|TWO_SIDED|95.0|-54734.08|90922.71|||ANCOVA|||||90922.71|-54734.08|0.6209
91626472|NCT00871572|183144976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5783.59||||0.8581|TWO_SIDED|95.0|-58650.71|70217.89|||ANCOVA|||||70217.89|-58650.71|0.8581
91626473|NCT00871572|183144976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36218.98||||0.285|TWO_SIDED|95.0|-30955.5|103393.46|||ANCOVA|||||103393.46|-30955.50|0.2850
91626474|NCT00871572|183144977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.584|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.584
91626475|NCT00871572|183144977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.426|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.426
91626476|NCT00871572|183144977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.657|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||||0.4|-0.6|0.657
91626477|NCT00871572|183144978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.365|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.365
91626478|NCT00871572|183144978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.191|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.191
91626479|NCT00871572|183144978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.297|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.297
91663146|NCT01175135|183221537|OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.723||0.0031|TWO_SIDED|80.0|-2.93|-1.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.07|-2.93|0.0031
91663147|NCT01175135|183221538|OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.196||0.3598|TWO_SIDED|80.0|-0.32|0.18||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.18|-0.32|0.3598
91663148|NCT01175135|183221538|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.198||0.7275|TWO_SIDED|80.0|-0.13|0.37||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.37|-0.13|0.7275
91663149|NCT01175135|183221538|OTHER||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.255||0.0019|TWO_SIDED|80.0|-1.07|-0.42||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.42|-1.07|0.0019
91626480|NCT00871572|183144979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.523|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||||0.4|-0.8|0.523
91626481|NCT00871572|183144979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.476|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.476
91714043|NCT00810069|183319698|SUPERIORITY_OR_OTHER||LS Mean|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.401|TWO_SIDED|95.0|-0.19|0.47||P-value for Week 8: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.47|-0.19|0.401
91626482|NCT00871572|183144979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.634|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.634
91626483|NCT00871572|183144980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.919
91626484|NCT00871572|183144980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.864
91626485|NCT00871572|183144980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.726|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.726
91626486|NCT01938001|183144988|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.34|0.62|||Log Rank|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.62|0.34|< 0.0001
91626487|NCT01938001|183144989|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||0.0006
91626488|NCT01938001|183144990|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.37|0.95||||||Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||0.95|0.37|
91626489|NCT01938001|183144991|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||< 0.0001
91626490|NCT01938001|183144992|SUPERIORITY||||||=|0.001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||= 0.0010
91626491|NCT01938001|183144993|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0015|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||||0.79|0.36|0.0015
91626492|NCT01938001|183144994|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.2993|TWO_SIDED|95.0|0.32|1.43|||Log Rank|||||1.43|0.32|0.2993
91626493|NCT01938001|183144995|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Stratified Log-Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.67|0.38|< 0.0001
91626494|NCT01938001|183144996|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.71|||Stratified Log Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||0.71|0.39|<0.0001
91626495|NCT03205982|183145000|EQUIVALENCE|If the difference (between treatment and control arm) is greater than the minimal clinically important difference (MCID), we consider the treatment arm is different from the control arm. MCID is calculated as 0.25-0.5\* standard deviation (SD). Conversely, the equivalence margin is the biggest difference (between 2 arms) to be considered no difference between 2 arms. Therefore, the equivalence margin should be smaller than MCID, i.e., it should be smaller than the smallest possible MCID.|Odds Ratio (OR)|0.9943|STANDARD_ERROR_OF_MEAN|0.0005|<|0.0001|TWO_SIDED|95.0|0.993|0.995|||Mixed Models Analysis|generalized linear mixed model with logit link (logistic model)||Compares difference in adherence changes between Intervention and Control arms||0.995|0.993|<0.0001
91626496|NCT01468701|183145012|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.6|0.9|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.90|0.60|
91626497|NCT01468701|183145014|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.63|0.98|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.98|0.63|
91626498|NCT01468701|183145015|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.57|1.11|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.11|0.57|
91626499|NCT01468701|183145017|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.14|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.14|0.57|
91626500|NCT01468701|183145025|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.73|0.38|
91626501|NCT01468701|183145029|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.57|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.57|0.60|
91626502|NCT01468701|183145031|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.54|0.8|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.80|0.54|
91626503|NCT03404219|183145057|OTHER|Single group pre-post, follow-up|Mean Difference (Final Values)|2.56||||0.09|TWO_SIDED||||||General Linear Model (repeated measures)|||Single arm||||0.09
91626504|NCT02853123|183145086|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.153||0.0217|TWO_SIDED|95.0|-0.661|-0.053|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.053|-0.661|0.0217
91626505|NCT02853123|183145087|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.106|0.265|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured prior to exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.265|0.106|<.0001
91663150|NCT01175135|183221539|OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.478||0.5429|TWO_SIDED|80.0|-2.06|1.74||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||1.74|-2.06|0.5429
91663151|NCT01175135|183221539|OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|1.492||0.4354|TWO_SIDED|80.0|-1.68|2.16||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||2.16|-1.68|0.4354
91663152|NCT01175135|183221539|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|1.907||0.093|TWO_SIDED|80.0|0.08|4.99||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||4.99|0.08|0.0930
91792042|NCT01857310|183461830|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||0.5|-0.3|
91626506|NCT02853123|183145088|SUPERIORITY||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.038||0.0852|TWO_SIDED|95.0|-0.009|0.141|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured end of exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.141|-0.009|0.0852
91626507|NCT02853123|183145089|SUPERIORITY||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.117|0.194|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.194|0.117|<.0001
91626508|NCT02853123|183145090|SUPERIORITY||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.134|0.267|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.267|0.134|<.0001
91626509|NCT02853123|183145091|SUPERIORITY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.096||0.2645|TWO_SIDED|95.0|-0.3|0.083|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|1 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.083|-0.300|0.2645
91626510|NCT02853123|183145091|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0267|TWO_SIDED|95.0|-0.452|-0.028|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.028|-0.452|0.0267
91626511|NCT02853123|183145091|SUPERIORITY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.596|-0.039|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.039|-0.596|0.0258
91626512|NCT02853123|183145092|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.8025|TWO_SIDED|95.0|-0.268|0.208|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.208|-0.268|0.8025
91626513|NCT02853123|183145093|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.3634|TWO_SIDED|95.0|-0.106|0.286|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.286|-0.106|0.3634
91626514|NCT01391468|183145094|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91663153|NCT02284867|183221551|NON_INFERIORITY_OR_EQUIVALENCE|"Multivariable binary logistic regression was done to examine the relation between CD16+ NK and preterm labor as adjusted for other confounding factors the enter method was used to build the regression model.~A two-sided p-value \<0.05 was considered statistically significant."|Odds Ratio (OR)|65.01|STANDARD_ERROR_OF_MEAN|1.14|<|0.0002|TWO_SIDED|95.0|6.96|606.76||To our best of known , no previous human studies was analyzing this issue|Regression, Logistic|||"Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value \<0.05 was considered statistically significant."||606.76|6.96|<0.0002
91691909|NCT00380874|183278450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.5||0.1569||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.1569
91527786|NCT01678820|182930627|SUPERIORITY_OR_OTHER||Difference in least squares means|0.19||||0.267|TWO_SIDED|95.0|-0.14|0.52|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment||||0.52|-0.14|0.267
91626515|NCT01391468|183145095|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.744
91626516|NCT01391468|183145096|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0042
91626517|NCT01391468|183145097|SUPERIORITY_OR_OTHER|||||||0.0099|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0099
91626518|NCT01510834|183145111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.824|STANDARD_DEVIATION|14.148||0.001|TWO_SIDED|95.0|-10.578|-3.07|||t-test, 2 sided|||||-3.070|-10.578|.001
91626519|NCT01510834|183145112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0872|STANDARD_DEVIATION|15.731||0.001|TWO_SIDED|95.0|2.91|11.26|||t-test, 2 sided|||||11.26|2.91|.001
91626520|NCT01510834|183145113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78|STANDARD_DEVIATION|7.78|<|0.001|TWO_SIDED|95.0|-5.84|-1.7|||t-test, 2 sided|||||-1.70|-5.84|<.001
91626521|NCT01510834|183145114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|6.269||0.015|TWO_SIDED|95.0|-3.751|-0.4244|||t-test, 2 sided|||||-.4244|-3.751|.015
91626522|NCT00633893|183145151|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3283|||<|0.0001|TWO_SIDED|95.0|0.2225|0.4844||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4844|0.2225|<0.0001
91626523|NCT00633893|183145151|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3615|||<|0.0001|TWO_SIDED|95.0|0.2475|0.5281||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.||0.5281|0.2475|<0.0001
91626524|NCT00633893|183145152|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2891|||<|0.0001|TWO_SIDED|95.0|0.1902|0.4395||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4395|0.1902|<0.0001
91626525|NCT00633893|183145152|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3774|||<|0.0001|TWO_SIDED|95.0|0.2577|0.5525||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5525|0.2577|<0.0001
91626526|NCT00633893|183145153|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2422|||<|0.0001|TWO_SIDED|95.0|0.1476|0.3975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3975|0.1476|<0.0001
91626527|NCT00633893|183145153|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.1861|||<|0.0001|TWO_SIDED|95.0|0.1062|0.3261||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3261|0.1062|<0.0001
91691910|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7207||95.0|-0.25|0.17||Model terms include treatment, study center, and baseline score.|ANCOVA|Cycle 1. No multiple comparisons adjustment was made.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1.||0.17|-0.25|0.7207
91527787|NCT01678820|182930628|SUPERIORITY_OR_OTHER||Difference in percents|-0.4|||||TWO_SIDED|95.0|-10.2|9.3|||||Based on Miettinen \& Nurminen method|||9.3|-10.2|
91691911|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.3111||95.0|-0.36|1.1||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2.||1.10|-0.36|0.3111
91482222|NCT03981822|182838325|SUPERIORITY|||||||0.019||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0190
91626528|NCT00633893|183145154|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2799|||<|0.0001|TWO_SIDED|95.0|0.1844|0.4247||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4247|0.1844|<0.0001
91663154|NCT02927639|183221556|SUPERIORITY|"A subject was considered completed if they completed all 3 SCI (as indicated in participant flow section) - 13 control, 10 intervention.~However, the mixed model took in to account ALL available data. As such, there were 70 control, 65 intervention that completed at least 1 SCI. Their data was analyzed by the model and used to predict later outcomes so they were considered to be included in the analysis."||||||0.035||||||The mixed model may provide a significantly different change in SCI score from baseline to the 6 month using a per-protocol analysis in the intervention group as compared to the control group. A p value \<0.05 was considered significant.|Mixed Models Analysis|||A multilevel mixed effects linear regression model was used to analyze this data. This analysis allowed for an estimation of missing data. This explains the discrepancy in the number of participant study completion vs participant data analyzed (see below).||||0.035
91663155|NCT02699463|183221562|SUPERIORITY||||||<|0.01||||||The calculated p-value was \<0.01|ANCOVA|||||||<0.01
91663156|NCT02488239|183221563|OTHER||||||<|0.001|||||||exact binomial rate|||||||<0.001
91626529|NCT00633893|183145154|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3653|||<|0.0001|TWO_SIDED|95.0|0.25|0.5338||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5338|0.2500|<0.0001
91626530|NCT00633893|183145155|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2615|||<|0.0001|TWO_SIDED|95.0|0.1593|0.4292||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4292|0.1593|<0.0001
91626531|NCT00633893|183145155|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3972|||<|0.0001|TWO_SIDED|95.0|0.2595|0.6079||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.6079|0.2595|<0.0001
91626532|NCT00633893|183145156|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6087||||0.1084|TWO_SIDED|95.0|0.3653|1.0145||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0145|0.3653|0.1084
91626533|NCT00633893|183145156|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6846||||0.1329|TWO_SIDED|95.0|0.4164|1.1257||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1257|0.4164|0.1329
91663157|NCT02488239|183221564|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91663158|NCT05283148|183221565|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.321||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the lumbar spine. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.321
91482223|NCT03981822|182838325|SUPERIORITY|||||||0.0184||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
91482224|NCT03981822|182838325|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0048
91626534|NCT00633893|183145157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.647||||0.3059|TWO_SIDED|95.0|0.3543|1.1813||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1813|0.3543|0.3059
91626535|NCT00633893|183145157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9416||||0.8288|TWO_SIDED|95.0|0.5458|1.6245||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.6245|0.5458|0.8288
91626536|NCT00633893|183145158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5794||||0.1316|TWO_SIDED|95.0|0.3215|1.0443||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0443|0.3215|0.1316
91663159|NCT05283148|183221566|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.714||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA lumbar spine scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.714
91663160|NCT05283148|183221567|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.09||||||p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the total hip. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.09
91663161|NCT05283148|183221568|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.604||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA total hip scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.604
91663162|NCT05283148|183221569|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.013||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the femoral neck. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.013
91663163|NCT05283148|183221570|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.166||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA femoral neck scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.166
91663164|NCT05283148|183221571|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.23||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (interquartile range) for each group, based on the ASCQ-Me Pain Impact instrument (lower scores indicate worse pain impact). Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.23
91663165|NCT04414930|183221573|SUPERIORITY|Repeated measures ANOVA||||||0.28||||||The threshold for statistical significance was p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.28
91663166|NCT04414930|183221574|SUPERIORITY|Repeated measure ANOVA||||||0.05||||||The threshold for statistical significance was p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.05
91663167|NCT04414930|183221575|SUPERIORITY|Repeated measure ANOVA||||||0.93||||||The threshold for significance was p\<0.05|ANOVA|||||||0.93
91663168|NCT04414930|183221576|SUPERIORITY|Repeated measure ANOVA||||||0.43||||||The threshold for significance was p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.43
91663169|NCT04414930|183221577|SUPERIORITY|Repeated measure ANOVA||||||0.77||||||The threshold for significance was p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.77
91714044|NCT00810069|183319698|SUPERIORITY_OR_OTHER||LS Mean|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.618|TWO_SIDED|95.0|-0.27|0.46||P-value for Week 12: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.46|-0.27|0.618
91663170|NCT04414930|183221578|SUPERIORITY|Repeated measure ANOVA||||||0.5||||||The threshold for significance is p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.50
91663171|NCT04414930|183221579|SUPERIORITY|Repeated measure ANOVA||||||0.636||||||The threshold for significance is p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.636
91663172|NCT04414930|183221580|SUPERIORITY|Repeated measure ANOVA||||||0.19||||||The threshold for significance was p\<0.05|ANOVA|Repeated measure ANOVA group x time||||||0.19
91482225|NCT03981822|182838325|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0075
91482226|NCT03981822|182838325|SUPERIORITY|||||||0.0539||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.0539
91482227|NCT03981822|182838325|SUPERIORITY|||||||0.1638||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.1638
91663173|NCT03325881|183221592|SUPERIORITY||Difference in LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|2.48||0.451|TWO_SIDED|95.0|-6.8|3.1|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the linear mixed-effects model for repeated measures (MMRM) that included treatment group, nominal visit, age group, interaction of the treatment group with the visits as factors, baseline ADHD-RS5 total score as a covariate and an adjustment for the interaction of the baseline ADHD-RS-5 Total Score with the visit.||3.1|-6.8|0.451
91663174|NCT03325881|183221593|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.597|TWO_SIDED|95.0|-0.5|0.3|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, age group,interaction of the treatment group with the visit as factors, baseline CGI-S as a covariate and an adjustment for the interaction of the baseline CGI-S with the visit.||0.3|-0.5|0.597
91663175|NCT03676634|183221603|OTHER||single proportion|0.844|||||TWO_SIDED|95.0|0.672|0.947|||||Values listed in table are for Type A. Estimated Value for the Estimation Parameter for type B = 0.875. Lower limit = 0.710, upper limit = 0.965|Consider increase from baseline to post-dose values. Parameter is proportion achieving desired increase (≥ 3x or 4x increase in Type A and Type B NAC).|Proportion of participants achieving ≥ 3x or 4x increase in NAC values was calculated for both Type A and Type B. Primary endpoint was achieved if both Type A and Type B had proportion ≥50%.|.947|.672|
91663176|NCT00829712|183221607|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.95||||||90.0|94.02|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.39|94.02|
91663177|NCT00829712|183221608|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|95.08|103.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.19|95.08|
91663178|NCT00829712|183221609|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.94||||||90.0|96.08|103.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.95|96.08|
91663179|NCT03466866|183221628|SUPERIORITY||Incidence rate ratio|0.67||||0.12|TWO_SIDED|95.0|0.42|1.07|||Poisson regression|We adjusted for stratification variables, sex, baseline MOCA, number of medical conditions, PSQ Communication, and PSQ General satisfaction.||We used Poisson regression to model the number of outcome events as a function of randomization assignment, adjusting for the stratification variables and using follow-up time as the offset term. We calculated estimates of annual rates of the primary outcome and the adjusted estimate of the rate ratio. We evaluated the primary hypothesis by testing the null hypothesis that the rate ratio for randomization assignment equals 1.||1.07|.42|.12
91691912|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.48||0.5925||95.0|-0.7|1.22||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3.||1.22|-0.70|0.5925
91691913|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5812||95.0|-0.8|1.41||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4.||1.41|-0.80|0.5812
91691914|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.7||0.2925||95.0|-0.67|2.16||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5.||2.16|-0.67|0.2925
91482228|NCT03981822|182838325|SUPERIORITY|||||||0.4766||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.4766
91482229|NCT03981822|182838325|SUPERIORITY|||||||0.1588||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.1588
91482230|NCT03981822|182838326|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.|Cochran-Mantel-Haenszel|||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.3642
91482231|NCT03981822|182838326|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.0356
91482232|NCT03981822|182838326|SUPERIORITY|||||||0.0118|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0118
91482233|NCT03981822|182838326|SUPERIORITY|||||||0.0026||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.||||0.0026
91663180|NCT03466866|183221629|SUPERIORITY|General Satisfaction|Mean Difference (Final Values)|0.11||||0.502|TWO_SIDED|95.0|-0.22|0.45|||Regression, Linear|||We modeled PSQ- scores as continuous variables to estimate average change over time by treatment group. We used mixed effects linear regression with fixed effects for time (baseline, and months 6 and 12), randomization assignment, and time by randomization interaction. A random intercept term and an appropriate covariance structure was used to account for correlation among repeated measurements.||.45|-.22|.502
91663181|NCT03466866|183221630|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.23|TWO_SIDED|95.0|0.16|0.69|||ANCOVA|||Analysis of covariance was performed with Number of Quality Metrics as the dependent variable, treatment arm as the main independent variable of interest and the stratification variables as adjusting variables.||.69|.16|.23
91663182|NCT03466866|183221631|SUPERIORITY||Mean Difference (Net)|4.45||||0.094|TWO_SIDED|95.0|-0.76|9.66|||Mixed Models Analysis|||We used mixed effects linear regression. Fixed effects included time (baseline, and months 6 and 12), randomization assignment, time by randomization interaction, and the three stratification variables. From the results of this model, we estimated the mean change from baseline to 6 months, 6 months to 12 months and baseline to 12 months within each treatment group. We then compared the change from baseline to 12 months between the two groups.||9.66|-.76|.094
91663183|NCT01172145|183221632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|4.86||0.181|TWO_SIDED|95.0|-16.86|3.4|||t-test, 2 sided|||||3.40|-16.86|0.181
91663184|NCT04134091|183221640|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91663185|NCT04134091|183221640|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91663186|NCT04134091|183221641|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
91663187|NCT04134091|183221641|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91663188|NCT04134091|183221642|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91663189|NCT04134091|183221642|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
91663190|NCT04134091|183221643|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91663191|NCT04134091|183221643|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91663192|NCT04134091|183221644|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91663193|NCT04134091|183221644|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91663194|NCT04134091|183221645|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||>0.05
91663195|NCT04134091|183221645|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||<0.05
91663196|NCT04134091|183221645|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
91527788|NCT01678820|182930628|SUPERIORITY_OR_OTHER||Difference in percents|-4.3|||||TWO_SIDED|95.0|-14.7|5.8|||||Based on Miettinen \& Nurminen method|||5.8|-14.7|
91663197|NCT04134091|183221645|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
91663198|NCT04134091|183221645|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.01
91663199|NCT04134091|183221645|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.001
91663200|NCT04134091|183221646|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91663201|NCT04134091|183221646|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91663202|NCT04134091|183221647|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91663203|NCT04134091|183221647|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91663204|NCT04134091|183221648|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91663205|NCT04134091|183221648|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91663206|NCT04134091|183221649|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91663207|NCT04134091|183221649|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91663208|NCT04134091|183221650|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91663209|NCT04134091|183221650|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91663210|NCT04134091|183221651|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: AST||||>0.05
91663211|NCT04134091|183221651|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: AST||||<0.01
91663212|NCT04134091|183221651|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALT||||>0.05
91663213|NCT04134091|183221651|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: ALT||||< 0.01
91663214|NCT04134091|183221651|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||>0.05
91663215|NCT04134091|183221651|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||<0.05
91663216|NCT04134091|183221651|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||>0.05
91663217|NCT04134091|183221651|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||<0.05
91663218|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
91663219|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
91663220|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
91663221|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
91663222|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
91663223|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
91663224|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
91663225|NCT04134091|183221652|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
91663226|NCT01848938|183221653|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Linear Mixed Models analysis|||analysis between groups||||<0.001
91663227|NCT01848938|183221654|SUPERIORITY_OR_OTHER|||||||0.005|||||||Linear Mixed Models analysis|||analysis between groups||||0.005
91663228|NCT01848938|183221655|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.023
91663229|NCT01848938|183221657|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.001
91663230|NCT01848938|183221658|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
91663231|NCT01640197|183221659|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91792043|NCT01857310|183461830|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.25|8.95|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||8.95|0.25|
91626537|NCT00633893|183145158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8433||||0.5288|TWO_SIDED|95.0|0.4959|1.4341||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.4341|0.4959|0.5288
91663232|NCT01640197|183221660|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91663233|NCT01640197|183221661|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91663234|NCT01640197|183221662|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91663235|NCT01640197|183221663|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91663236|NCT01640197|183221664|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91663237|NCT01640197|183221665|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91663238|NCT00909753|183221666|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.5||||||90.0|85.8|99.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.7|85.8|
91663239|NCT00909753|183221667|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.5||||||90.0|92.2|98.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.9|92.2|
91663240|NCT00909753|183221668|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.3|83.1|
91663241|NCT00909753|183221669|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.5|95.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.9|85.5|
91663242|NCT00909753|183221670|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.5|99.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.5|85.5|
91663243|NCT00909753|183221671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.0||||||90.0|91.3|98.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.7|91.3|
91663244|NCT00909753|183221672|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% COnfidence Interval falls within 80-125.|||98.3|83.1|
91663245|NCT00909753|183221673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.0|96.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.3|85.0|
91663246|NCT00835536|183221674|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|93.1|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|93.1|
91663247|NCT00835536|183221675|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.5||||||90.0|92.1|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|92.1|
91663248|NCT03527485|183221685|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in ventral striatum (VS).||||||0.011|||||||ANOVA|||||||0.011
91663249|NCT03527485|183221685|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in Prefrontal cortex (PFC).||||||0.044|||||||ANOVA|||||||0.044
91663250|NCT06041256|183221712|OTHER||Difference in response rates|30.2||||0.0722|TWO_SIDED|95.0|0.8|58.3|||Fisher Exact|||||58.3|0.8|0.0722
91663251|NCT06041256|183221712|OTHER||Difference in response rates|-3.8|||>|0.9999|TWO_SIDED|95.0|-28.1|20.6|||Fisher Exact|||||20.6|-28.1|>0.9999
91663252|NCT06041256|183221712|OTHER||Difference in response rates|22.6||||0.1482|TWO_SIDED|95.0|-5.5|50.6|||Fisher Exact|||||50.6|-5.5|0.1482
91663253|NCT06041256|183221712|OTHER||Difference in response rates|35.7||||0.0203|TWO_SIDED|95.0|5.9|61.6|||Fisher Exact|||||61.6|5.9|0.0203
91663254|NCT06041256|183221712|OTHER||Difference in response rates|-33.9||||0.0293|TWO_SIDED|95.0|-60.3|-4.6|||Fisher Exact|||||-4.6|-60.3|0.0293
91663255|NCT06041256|183221712|OTHER||Difference in response rates|-7.6||||0.7431|TWO_SIDED|95.0|-38.9|25.3|||Fisher Exact|||||25.3|-38.9|0.7431
91663256|NCT06041256|183221712|OTHER||Difference in response rates|5.6||||0.7568|TWO_SIDED|95.0|-26.8|37.3|||Fisher Exact|||||37.3|-26.8|0.7568
91663257|NCT06041256|183221713|OTHER||Least square mean difference|20.4||||0.0232|TWO_SIDED|95.0|2.9|38.0|||ANCOVA|||||38.0|2.9|0.0232
91663258|NCT06041256|183221713|OTHER||Least square mean difference|9.8||||0.26|TWO_SIDED|95.0|-7.4|27.1|||ANCOVA|||||27.1|-7.4|0.2600
91663259|NCT06041256|183221713|OTHER||Least square mean difference|22.5||||0.0115|TWO_SIDED|95.0|5.2|39.9|||ANCOVA|||||39.9|5.2|0.0115
91663260|NCT06041256|183221713|OTHER||Least square mean difference|36.0|||<|0.0001|TWO_SIDED|95.0|18.5|53.4|||ANCOVA|||||53.4|18.5|<0.0001
91663261|NCT06041256|183221713|OTHER||Least square mean difference|-10.6||||0.2403|TWO_SIDED|95.0|-28.4|7.2|||ANCOVA|||||7.2|-28.4|0.2403
91663262|NCT06041256|183221713|OTHER||Least square mean difference|2.1||||0.8138|TWO_SIDED|95.0|-15.7|19.9|||ANCOVA|||||19.9|-15.7|0.8138
91663263|NCT06041256|183221713|OTHER||Least square mean difference|15.5||||0.0834|TWO_SIDED|95.0|-2.1|33.2|||ANCOVA|||||33.2|-2.1|0.0834
91663264|NCT06041256|183221714|OTHER||Least square mean difference|-75.1||||0.0147|TWO_SIDED|95.0|-135.2|-15.1|||ANCOVA|||||-15.1|-135.2|0.0147
91663265|NCT06041256|183221714|OTHER||Least square mean difference|-81.3||||0.0077|TWO_SIDED|95.0|-140.5|-22.0|||ANCOVA|||||-22.0|-140.5|0.0077
91663266|NCT06041256|183221714|OTHER||Least square mean difference|-73.1||||0.0165|TWO_SIDED|95.0|-132.6|-13.7|||ANCOVA|||||-13.7|-132.6|0.0165
91663267|NCT06041256|183221714|OTHER||Least square mean difference|-81.7||||0.0079|TWO_SIDED|95.0|-141.4|-22.0|||ANCOVA|||||-22.0|-141.4|0.0079
91663268|NCT06041256|183221714|OTHER||Least square mean difference|-6.1||||0.8443|TWO_SIDED|95.0|-67.8|55.6|||ANCOVA|||||55.6|-67.8|0.8443
91663269|NCT06041256|183221714|OTHER||Least square mean difference|2.0||||0.949|TWO_SIDED|95.0|-60.1|64.1|||ANCOVA|||||64.1|-60.1|0.9490
91663270|NCT06041256|183221714|OTHER||Least square mean difference|-6.6||||0.8324|TWO_SIDED|95.0|-68.1|55.0|||ANCOVA|||||55.0|-68.1|0.8324
91663271|NCT00835705|183221733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.03||||||90.0|98.4|107.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.88|98.40|
91663272|NCT00835705|183221734|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.43||||||90.0|96.71|100.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.18|96.71|
91663273|NCT00835705|183221735|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.29||||||90.0|96.58|100.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.03|96.58|
91663274|NCT00835705|183221736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.16||||||90.0|95.33|111.64|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||111.64|95.33|
91663275|NCT00835705|183221737|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.79||||||90.0|95.75|112.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.50|95.75|
91663276|NCT00835705|183221738|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|104.26||||||90.0|95.76|113.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||113.52|95.76|
91663277|NCT05090839|183221747|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|variance explained by the IV.|0.072|||<|0.05|TWO_SIDED|95.0|0.0|0.234|||ANOVA|||||.234|.0000|<0.05
91714045|NCT00810069|183319698|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.856|TWO_SIDED|95.0|-0.43|0.36||P-value for Week 16: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.36|-0.43|0.856
91663278|NCT05090839|183221749|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.358|||<|0.05|TWO_SIDED|95.0|0.0|0.554|||ANOVA|||This is a comparison that is specific to the contrast of visualizing traumatic versus stressful events.||.554|0|<0.05
91663279|NCT05090839|183221750|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.51|||<|0.05|TWO_SIDED|95.0|0.0|0.676|||ANOVA|||||.676|.000|<0.05
91663280|NCT00834964|183221762|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|92.72|101.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.49|92.72|
91663281|NCT00834964|183221763|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.7||||||90.0|94.74|104.92|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.92|94.74|
91663282|NCT00834964|183221764|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|93.46|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|93.46|
91663283|NCT00834964|183221765|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.29||||||90.0|91.96|100.82|||||Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.|||100.82|91.96|
91663284|NCT00834964|183221766|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.1||||||90.0|100.08|108.29|||||Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||108.29|100.08|
91482234|NCT03981822|182838326|SUPERIORITY|||||||0.0174|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.0174
91626538|NCT00633893|183145159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6577||||0.2361|TWO_SIDED|95.0|0.3874|1.1169||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1169|0.3874|0.2361
91626539|NCT00633893|183145159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7708||||0.3155|TWO_SIDED|95.0|0.4631|1.2832||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.2832|0.4631|0.3155
91626540|NCT00633893|183145161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.485||||0.3925|TWO_SIDED|95.0|0.0891|2.6391||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.||2.6391|0.0891|0.3925
91626541|NCT00633893|183145161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2457||||0.3551|TWO_SIDED|95.0|0.0269|2.2437||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.||2.2437|0.0269|0.3551
91626542|NCT00633893|183145162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2027||||0.5148|TWO_SIDED|95.0|0.6897|2.0975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.0975|0.6897|0.5148
91626543|NCT00633893|183145162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.616||||0.1412|TWO_SIDED|95.0|0.9554|2.7336||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.7336|0.9554|0.1412
91626544|NCT00633893|183145163|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2928||||0.3932|TWO_SIDED|95.0|0.7158|2.3348||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||2.3348|0.7158|0.3932
91626545|NCT00633893|183145163|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8235||||0.0621||95.0|1.047|3.176||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||3.1760|1.0470|0.0621
91626546|NCT00633893|183145164|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2579||||0.1691|TWO_SIDED|95.0|0.9064|1.7457||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||1.7457|0.9064|0.1691
91663285|NCT00834964|183221767|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.52||||||90.0|97.3|103.84|||||Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.|||103.84|97.30|
91663286|NCT02826694|183221770|OTHER|||||||0.168|||||||linear mixed effect model|||T3||||0.168
91663287|NCT02826694|183221770|OTHER|||||||0.026|||||||linear mixed effect model|||T4||||0.026
91482235|NCT03981822|182838326|SUPERIORITY|||||||0.1311|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1311
91482236|NCT03981822|182838326|SUPERIORITY|||||||0.0967|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.0967
91482237|NCT03981822|182838326|SUPERIORITY|||||||0.1357|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.1357
91663288|NCT03364192|183221802|OTHER|Multilevel modeling adapted for multiple-baseline design comparing participant goal attainment before, during, and after peer-delivered Whole Health Coaching.|||||<|0.05|||||||Multilevel Modeling|||||||<0.05
91482238|NCT03981822|182838326|SUPERIORITY|||||||0.0184|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
91663289|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|1.54||||0.504|TWO_SIDED|||||Adjusted for TIF introduction and time periods as fixed effects and hospitals and time periods as random effects.|generalized linear mixed regression mode|||For mobility on EU arrival assessed,||||0.504
91663290|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.31||||0.169|TWO_SIDED||||||generalized linear mixed regression mode|||Respiratory rate at EU assessed||||0.169
91663291|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|25.29||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Airway assessed||||0.006
91663292|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|38.38||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Chest examined||||0.001
91663293|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|93.01||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Intra-abdominal bleeding evaluated||||0.001
91663294|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|354.91||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Spine Immobilized for RTI or Fall Victims||||0.001
91663295|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|4.95||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Splinting of Fractures Considered||||0.001
91663296|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|5.18||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Tetanus Considered for bites, burns, lacerations, and abrasions||||0.006
91663297|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.03||||0.047|TWO_SIDED||||||generalized linear mixed regression|||Date of Injury Recorded||||0.047
91663298|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||Death||||0.166
91663299|NCT04547192|183221812|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.14||||0.013|TWO_SIDED||||||generalized linear mixed regression|||Important Clinical Data Document||||0.013
91663300|NCT04547192|183221813|SUPERIORITY||Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||||||0.166
91663301|NCT01108445|183221886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.157|TWO_SIDED||||||Log Rank|||||||0.157
91663302|NCT01108445|183221888|SUPERIORITY_OR_OTHER||Median PFS|5.6|||||TWO_SIDED||||||||The 95% CI for the HC was (4,6). If the median PFS for RAD001 is within the 95% CI for the HC, it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for RAD001 arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
91663303|NCT01108445|183221888|SUPERIORITY_OR_OTHER||Median PFS|8.3|||||TWO_SIDED||||||||95% CI for HC was(4,6). If the median PFS for Sunitinib is within the 95% CI for the HC,it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for Sunitinib arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
91663304|NCT01108445|183221890|SUPERIORITY_OR_OTHER|||||||0.589|TWO_SIDED||||||Chi-squared|||||||0.589
91663305|NCT01108445|183221891|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||||||0.066
91691915|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.54||0.9276||95.0|-1.15|1.05||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.||1.05|-1.15|0.9276
91663306|NCT01484912|183221911|NON_INFERIORITY_OR_EQUIVALENCE|The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||||0.025||95.0|||||t-test, 1 sided|||T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T-△C≦0 with H1：△T-△C﹥0.||||0.025
91663307|NCT01484912|183221912|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||0.005
91663308|NCT00911274|183221919|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.41||||||90.0|82.77|103.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.18|82.77|
91663309|NCT00911274|183221920|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.3||||||90.0|97.84|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.88|97.84|
91663310|NCT00911274|183221921|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|97.77|104.34|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.34|97.77|
91714046|NCT00810069|183319699|SUPERIORITY_OR_OTHER||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.021|TWO_SIDED|95.0|-0.1|-0.01||P-value for Week 8: Analysis of early versus delayed intervention LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.01|-0.10|0.021
91714047|NCT00810069|183319699|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.071|TWO_SIDED|95.0|-0.09|0.0||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.00|-0.09|0.071
91714048|NCT00810069|183319699|SUPERIORITY_OR_OTHER||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.792|TWO_SIDED|95.0|-0.05|0.06||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.06|-0.05|0.792
91482239|NCT03981822|182838326|SUPERIORITY|||||||0.0024|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.||||0.0024
91626547|NCT00633893|183145164|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6971||||0.0013|TWO_SIDED|95.0|1.2468|2.3102||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||2.3102|1.2468|0.0013
91626548|NCT00633893|183145165|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2374||||0.1466|TWO_SIDED|95.0|0.9276|1.6507||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.||1.6507|0.9276|0.1466
91663311|NCT04603495|183221922|OTHER|The response rate between the 2 treatment groups was compared using CMH test.|Difference in proportion|30.4|||<|0.001|TWO_SIDED|95.0|21.6|39.3|||Cochran-Mantel-Haenszel|CMH 95% CI adjusted by strata; Mehrotra-Railkar test used if Breslow-Day significant; DIPSS High merged with Int-2 due to low counts.|The proportion difference = experimental group (Pela + RUX) - control group (placebo + RUX).|Splenic Response Rate at Week 24||39.3|21.6|<0.001
91663312|NCT04603495|183221923|OTHER||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|1.009||0.0545|TWO_SIDED|95.0|-3.92|0.04|||ANCOVA|||Absolute Change from Baseline in Total Symptom Score (TSS) at Week 24||0.04|-3.92|0.0545
91663313|NCT04603495|183221924|OTHER|The response rate between the 2 treatment groups was compared using CMH test.|Difference in proportions|6.0||||0.216|TWO_SIDED|95.0|-3.4|15.5|||Cochran-Mantel-Haenszel|CMH 95% CI adjusted by strata; Mehrotra-Railkar test used if Breslow-Day significant; DIPSS High merged with Int-2 due to low counts.|Proportion Difference = Experimental Group (Pela + RUX) - Control Group (placebo + RUX).|Percentage of TSS50 at Week 24||15.5|-3.4|0.216
91663314|NCT04603495|183221926|OTHER||Difference in proportions|7.63||||0.037|TWO_SIDED|95.0|0.52|14.73|||Cochran-Mantel-Haenszel|CMH 95% CI adjusted across the strata including baseline DIPSS, platelet count, and spleen volume.|Proportion Difference = Experimental Group (Pela + RUX) - Control Group (placebo + RUX).|≥1 Grade improvement From Baseline in Bone Marrow Fibrosis at Week 24||14.73|0.52|0.037
91663315|NCT04603495|183221945|OTHER||Difference in Proportions|7.8||||0.107|TWO_SIDED|95.0|-1.7|17.2|||Cochran-Mantel-Haenszel|CMH 95% CI adjusted by strata; Mehrotra-Railkar test used if Breslow-Day significant; DIPSS High merged with Int-2 due to low counts.|The proportion difference = experimental group (Pela + RUX) - control group (placebo + RUX). Wald 95% CIs were applied.|Modified Total Symptom Score (mTSS) Response at Week 24||17.2|-1.7|0.107
91792044|NCT01857310|183461831|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||0.4|-0.2|
91792045|NCT01857310|183461831|SUPERIORITY||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.18|21.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||21.9|0.18|
91626549|NCT00633893|183145165|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6468||||0.0005|TWO_SIDED|95.0|1.2552|2.1606||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.||2.1606|1.2552|0.0005
91626550|NCT02741310|183145173|OTHER|The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.|LS Mean Difference|-0.04|||||TWO_SIDED|90.0|-2.16|2.08||||||A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.||2.08|-2.16|
91626551|NCT02741310|183145175|OTHER||Geometric Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.03|0.93|
91626552|NCT02741310|183145176|OTHER||Geometric Least Squares Mean Ratio|1.0|||||TWO_SIDED|90.0|0.96|1.05||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.05|0.96|
91626553|NCT02741310|183145177|OTHER||Geometric Least Squares Mean Ratio|0.95|||||TWO_SIDED|90.0|0.82|1.09||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.09|0.82|
91626554|NCT00291187|183145226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.1|-9.9|||ANCOVA|||||-9.9|-33.1|<0.001
91626555|NCT00291187|183145226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.3|||<|0.001|TWO_SIDED|95.0|-37.8|-14.7|||ANCOVA|||||-14.7|-37.8|<0.001
91626556|NCT00291187|183145226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|||<|0.001|TWO_SIDED|95.0|-34.2|-11.3|||ANCOVA|||||-11.3|-34.2|<0.001
91626557|NCT00291187|183145227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2||||0.017|TWO_SIDED|95.0|-44.1|-4.3|||ANCOVA|||||-4.3|-44.1|0.017
91626558|NCT00291187|183145227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.7||||0.001|TWO_SIDED|95.0|-53.6|-13.9|||ANCOVA|||||-13.9|-53.6|0.001
91626559|NCT00291187|183145227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.081|TWO_SIDED|95.0|-37.0|2.1|||ANCOVA|||||2.1|-37.0|0.081
91626560|NCT00291187|183145228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.7||||0.002|TWO_SIDED|95.0|13.0|54.5|||ANCOVA|||||54.5|13.0|0.002
91626561|NCT00291187|183145228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.9|||<|0.001|TWO_SIDED|95.0|27.2|68.6|||ANCOVA|||||68.6|27.2|<0.001
91626562|NCT00291187|183145228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6||||0.005|TWO_SIDED|95.0|9.1|50.0|||ANCOVA|||||50.0|9.1|0.005
91626563|NCT00291187|183145229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.006|TWO_SIDED|95.0|-18.9|-3.3|||ANCOVA|||||-3.3|-18.9|0.006
91626564|NCT00291187|183145229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.1|-6.5|||ANCOVA|||||-6.5|-22.1|<0.001
91626565|NCT00291187|183145229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3||||0.002|TWO_SIDED|95.0|-20.0|-4.6|||ANCOVA|||||-4.6|-20.0|0.002
91626566|NCT01957787|183145304|OTHER|||||||0.41||||||Estimates of the log odds and Wald standard error from a random effects logistic regression model were combined across imputed datasets for reference.|Random effects logistic regression model|||The null hypothesis was tested comparing the lower bound of the Wald 97.5% 1-sided confidence interval for the estimated rate of local tumor control to the performance goal of 84.0%. If the lower bound was greater than 84.0%, the null hypothesis was rejected and the endpoint was considered met.||||0.410
91663316|NCT02709018|183221962|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
91663317|NCT02709018|183221963|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||0.57
91663318|NCT00950989|183221987|SUPERIORITY||Difference in response rate|3.2||||0.598|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.598
91663319|NCT00950989|183221987|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
91663320|NCT00950989|183221987|SUPERIORITY||Difference in response rate|3.2||||0.635|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.635
91663321|NCT00950989|183221987|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.740
91663322|NCT00950989|183221987|SUPERIORITY||Difference in response rate|-3.2||||0.572|TWO_SIDED|95.0|-14.1|7.8||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||7.8|-14.1|0.572
91663323|NCT00950989|183221987|SUPERIORITY|||||||0.572||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.572
91626567|NCT01686958|183145316|OTHER|This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.|||||||ONE_SIDED|95.0||||Confidence intervals \[CI\] will be constructed for outcomes of interest at the alpha=0.05 level of significance, i.e. 95% CI.||||A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.|For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.|||
91626568|NCT01367860|183145374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|95.0|-4.05|0.26|||t-test, 2 sided|||||0.26|-4.05|0.05
91626569|NCT01367860|183145375|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91626570|NCT01367860|183145376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|-2.21|1.43|||t-test, 2 sided|||||1.43|-2.21|<0.05
91626571|NCT01367860|183145377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.01|<|0.05|TWO_SIDED|95.0|-2.76|1.33|||t-test, 2 sided|||||1.33|-2.76|<0.05
91626572|NCT01367860|183145379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.13|<|0.05|TWO_SIDED|95.0|-2.58|2.01|||t-test, 2 sided|||||2.01|-2.58|<0.05
91626573|NCT01367860|183145380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|1.14|<|0.05|TWO_SIDED|95.0|-1.3|3.3|||t-test, 2 sided|||||3.3|-1.3|<0.05
91626574|NCT01367860|183145381|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.77|<|0.05|TWO_SIDED|95.0|-2.36|8.8|||t-test, 2 sided|||||8.8|-2.36|<0.05
91626575|NCT01367860|183145382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-4.4|8.9|||t-test, 2 sided|||||8.9|-4.4|<0.05
91663324|NCT00950989|183221988|SUPERIORITY||Difference in response rates|-3.2||||0.728|TWO_SIDED|95.0|-20.4|14.0||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||14.0|-20.4|0.728
91663325|NCT00950989|183221988|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
91663326|NCT00950989|183221988|SUPERIORITY||Difference in response rates|-6.3||||0.412|TWO_SIDED|95.0|-23.4|10.7||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||10.7|-23.4|0.412
91482240|NCT03981822|182838326|SUPERIORITY|||||||0.1034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.1034
91626576|NCT01367860|183145383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-7.15|7.55|||t-test, 2 sided|||||7.55|-7.15|<0.05
91663327|NCT00950989|183221988|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedures|||||||0.740
91663328|NCT00950989|183221988|SUPERIORITY||Difference in response rates|3.2||||0.74|TWO_SIDED|95.0|-14.2|20.5||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||20.5|-14.2|0.740
91626577|NCT01367860|183145384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|-7.14|7.67|||t-test, 2 sided|||||7.67|-7.14|<0.05
91626578|NCT01367860|183145385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.18|<|0.05|TWO_SIDED|95.0|-8.16|4.76|||t-test, 2 sided|||||4.76|-8.16|<0.05
91626579|NCT01367860|183145386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|TWO_SIDED|95.0|-0.12|3.46|||t-test, 2 sided|||||3.46|-0.12|<0.05
91626580|NCT01367860|183145387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.09|<|0.05|TWO_SIDED|95.0|-2.0|2.4|||t-test, 2 sided|||||2.4|-2|<0.05
91626581|NCT01367860|183145388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.08|<|0.05|TWO_SIDED|95.0|-2.55|1.85|||t-test, 2 sided|||||1.85|-2.55|<0.05
91626582|NCT01367860|183145389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|1.11|<|0.05|TWO_SIDED|95.0|-2.29|2.23|||t-test, 2 sided|||||2.23|-2.29|<0.05
91626583|NCT01367860|183145390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.17|<|0.05|TWO_SIDED|95.0|-1.67|3.08|||t-test, 2 sided|||||3.08|-1.67|<0.05
91626584|NCT02481596|183145404|SUPERIORITY|||||||0.045||||||Beta=.083. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.045
91626585|NCT02481596|183145404|SUPERIORITY|||||||0.006||||||Beta=.126. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.006
91626586|NCT02481596|183145405|SUPERIORITY|||||||0.518||||||Beta=.031. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.518
91482241|NCT03981822|182838326|SUPERIORITY|||||||0.1029|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1029
91482242|NCT03981822|182838327|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0356
91626587|NCT02481596|183145405|SUPERIORITY|||||||0.092||||||Beta=.092. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.092
91482243|NCT03981822|182838327|SUPERIORITY|||||||0.1477|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.1477
91482244|NCT03981822|182838327|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0062
91482245|NCT03981822|182838327|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0046
91626588|NCT02481596|183145406|SUPERIORITY|||||||0.53||||||Beta=-.027. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations||||.53
91626589|NCT02481596|183145406|SUPERIORITY|||||||0.41||||||Beta=-.037. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.41
91626590|NCT02481596|183145407|SUPERIORITY|||||||0.024||||||Beta=.088. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.024
91626591|NCT02481596|183145407|SUPERIORITY|||||||0.003||||||Beta=.128. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.003
91626592|NCT02481596|183145408|SUPERIORITY|||||||0.001||||||Beta=-.133. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.001
91626593|NCT02481596|183145408|SUPERIORITY|||||||0.012||||||Beta=-.115. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.012
91626594|NCT02481596|183145409|SUPERIORITY|||||||0.015||||||Beta=.114. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.015
91626595|NCT02481596|183145409|SUPERIORITY|||||||0.034||||||Beta=.101. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.034
91626596|NCT00418717|183145425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||||95.0|-0.25|0.06||||||||0.06|-0.25|
91626597|NCT00631540|183145436|SUPERIORITY_OR_OTHER||Mean Patency Rate|91.7|||<|0.0001|TWO_SIDED|95.0|84.2|95.9|||Z-test, 1-sided||GEE model estimate.|Alternative hypothesis is 9-month primary patency rate greater than 60%.||95.9|84.2|<0.0001
91626598|NCT02437487|183145449|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
91626599|NCT02437487|183145451|SUPERIORITY||Relative Risk|1.2624|||||TWO_SIDED|95.0|0.7668|2.0785||||||||2.0785|0.7668|
91663329|NCT00950989|183221988|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
91482246|NCT03981822|182838327|SUPERIORITY|||||||0.0177|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0177
91626600|NCT02437487|183145452|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
91626601|NCT02437487|183145453|SUPERIORITY||Relative Risk|1.0878|||||TWO_SIDED|95.0|0.7383|1.6029||||||||1.6029|0.7383|
91626602|NCT01230749|183145497|SUPERIORITY_OR_OTHER||Difference in LSM|-27.4||||0.006|TWO_SIDED|95.0|-46.792|-8.008|||ANCOVA|||||-8.008|-46.792|0.006
91626603|NCT01230749|183145497|SUPERIORITY_OR_OTHER||Difference in LSM|-20.47||||0.038|TWO_SIDED|95.0|-39.801|-1.142|||ANCOVA|||||-1.142|-39.801|0.038
91626604|NCT01230749|183145497|SUPERIORITY_OR_OTHER||Difference in LSM|-13.24||||0.178|TWO_SIDED|95.0|-32.635|6.151|||ANCOVA|||||6.151|-32.635|0.178
91626605|NCT01230749|183145498|SUPERIORITY_OR_OTHER||Difference in LSM|-28.28||||0.005|TWO_SIDED|95.0|-47.606|-8.957|||ANCOVA|||||-8.957|-47.606|0.005
91626606|NCT01230749|183145498|SUPERIORITY_OR_OTHER||Difference in LSM|-21.97||||0.025|TWO_SIDED|95.0|-41.154|-2.786|||ANCOVA|||||-2.786|-41.154|0.025
91626607|NCT01230749|183145498|SUPERIORITY_OR_OTHER||Difference in LSM|-17.71||||0.069|TWO_SIDED|95.0|-36.86|1.431|||ANCOVA|||||1.431|-36.860|0.069
91626608|NCT01230749|183145499|SUPERIORITY_OR_OTHER||Difference in LSM|2.76||||0.628|TWO_SIDED|95.0|-8.542|14.054|||ANCOVA|||||14.054|-8.542|0.628
91626609|NCT01230749|183145499|SUPERIORITY_OR_OTHER||Difference in LSM|13.7||||0.018|TWO_SIDED|95.0|2.392|25.008|||ANCOVA|||||25.008|2.392|0.018
91626610|NCT01230749|183145499|SUPERIORITY_OR_OTHER||Difference in LSM|5.87||||0.303|TWO_SIDED|95.0|-5.417|17.148|||ANCOVA|||||17.148|-5.417|0.303
91626611|NCT01230749|183145500|SUPERIORITY_OR_OTHER||Difference in LSM|-1.86||||0.041|TWO_SIDED|95.0|-3.634|-0.082|||ANCOVA|||||-0.082|-3.634|0.041
91626612|NCT01230749|183145500|SUPERIORITY_OR_OTHER||Difference in LSM|-0.26||||0.769|TWO_SIDED|95.0|-2.033|1.509|||ANCOVA|||||1.509|-2.033|0.769
91626613|NCT01230749|183145500|SUPERIORITY_OR_OTHER||Difference in LSM|-0.69||||0.444|TWO_SIDED|95.0|-2.463|1.091|||ANCOVA|||||1.091|-2.463|0.444
91626614|NCT01230749|183145501|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|95.1||||0.774|TWO_SIDED|90.0|71.031|127.324|||ANCOVA|||||127.324|71.031|0.774
91663330|NCT00950989|183221989|SUPERIORITY||Difference in response rates|0.0||||0.984|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.984
91482247|NCT03981822|182838327|SUPERIORITY|||||||0.0054|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0054
91626615|NCT01230749|183145501|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|89.9||||0.555|TWO_SIDED|90.0|66.567|121.403|||ANCOVA|||||121.403|66.567|0.555
91482248|NCT03981822|182838327|SUPERIORITY|||||||0.0013|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.||||0.0013
91626616|NCT01230749|183145502|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|100.17||||0.968|TWO_SIDED|90.0|93.217|107.647|||ANCOVA|||||107.647|93.217|0.968
91626617|NCT01230749|183145502|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|101.18||||0.785|TWO_SIDED|90.0|94.179|108.7|||ANCOVA|||||108.700|94.179|0.785
91626618|NCT01230749|183145503|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|133.27||||0.097|TWO_SIDED|90.0|100.275|177.115|||ANCOVA|||||177.115|100.275|0.097
91626619|NCT01230749|183145503|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|101.82||||0.917|TWO_SIDED|90.0|76.26|135.942|||ANCOVA|||||135.942|76.260|0.917
91626620|NCT01230749|183145504|SUPERIORITY_OR_OTHER||Difference in LSM|0.46||||0.295|TWO_SIDED|95.0|-0.408|1.323|||ANCOVA|||||1.323|-0.408|0.295
91626621|NCT01230749|183145504|SUPERIORITY_OR_OTHER||Difference in LSM|0.03||||0.941|TWO_SIDED|95.0|-0.838|0.904|||ANCOVA|||||0.904|-0.838|0.941
91663331|NCT00950989|183221989|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
91663332|NCT00950989|183221989|SUPERIORITY||Difference in response rates|0.0||||0.993|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.993
91663333|NCT00950989|183221989|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
91663334|NCT00950989|183221989|SUPERIORITY||Difference in response rates|-3.2||||0.159|TWO_SIDED|95.0|-7.5|1.2||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||1.2|-7.5|0.159
91663335|NCT00950989|183221989|SUPERIORITY|||||||0.797||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.797
91482249|NCT03981822|182838327|SUPERIORITY|||||||0.0034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0034
91482250|NCT03981822|182838327|SUPERIORITY|||||||0.0156|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0156
91626622|NCT01230749|183145504|SUPERIORITY_OR_OTHER||Difference in LSM|1.02||||0.022|TWO_SIDED|95.0|0.15|1.892|||ANCOVA|||||1.892|0.150|0.022
91626623|NCT03906136|183145505|SUPERIORITY||Odds Ratio (OR)|0.69||||0.119|TWO_SIDED|95.0|0.43|1.1|||Regression, Logistic|||Week 24||1.10|0.43|0.119
91626624|NCT03906136|183145506|SUPERIORITY||Odds Ratio (OR)|0.59||||0.029|TWO_SIDED|95.0|0.37|0.95|||Regression, Logistic|||Week 12||0.95|0.37|0.029
91626625|NCT03906136|183145507|SUPERIORITY||Odds Ratio (OR)|0.71||||0.154|TWO_SIDED|95.0|0.45|1.14|||Regression, Logistic|||Week 12||1.14|0.45|0.154
91626626|NCT03906136|183145507|SUPERIORITY||Odds Ratio (OR)|0.87||||0.562|TWO_SIDED|95.0|0.54|1.39|||Regression, Logistic|||Week 24||1.39|0.54|0.562
91626627|NCT03906136|183145508|SUPERIORITY||Odds Ratio (OR)|0.55||||0.029|TWO_SIDED|95.0|0.32|0.94|||Regression, Logistic|||Week 12||0.94|0.32|0.029
91626628|NCT03906136|183145508|SUPERIORITY||Odds Ratio (OR)|0.74||||0.264|TWO_SIDED|95.0|0.44|1.25|||Regression, Logistic|||Week 24||1.25|0.44|0.264
91626629|NCT03906136|183145509|SUPERIORITY||Odds Ratio (OR)|0.49||||0.008|TWO_SIDED|95.0|0.29|0.83|||Regression, Logistic|||Week 12||0.83|0.29|0.008
91626630|NCT03906136|183145509|SUPERIORITY||Odds Ratio (OR)|0.47||||0.005|TWO_SIDED|95.0|0.28|0.8|||Regression, Logistic|||Week 24||0.80|0.28|0.005
91626631|NCT03906136|183145510|SUPERIORITY||Odds Ratio (OR)|0.72||||0.263|TWO_SIDED|95.0|0.4|1.28|||Regression, Logistic|||Week 12||1.28|0.40|0.263
91626632|NCT03906136|183145510|SUPERIORITY||Odds Ratio (OR)|0.61||||0.103|TWO_SIDED|95.0|0.34|1.1|||Regression, Logistic|||Week 24||1.10|0.34|0.103
91626633|NCT03906136|183145511|SUPERIORITY||Odds Ratio (OR)|0.64||||0.055|TWO_SIDED|95.0|0.4|1.01|||Regression, Logistic|||Week 12||1.01|0.40|0.055
91626634|NCT03906136|183145511|SUPERIORITY||Odds Ratio (OR)|0.82||||0.409|TWO_SIDED|95.0|0.52|1.31|||Regression, Logistic|||Week 24||1.31|0.52|0.409
91626635|NCT03906136|183145512|SUPERIORITY||Odds Ratio (OR)|0.85||||0.477|TWO_SIDED|95.0|0.53|1.34|||Regression, Logistic|||Week 12||1.34|0.53|0.477
91626636|NCT03906136|183145512|SUPERIORITY||Odds Ratio (OR)|1.01||||0.968|TWO_SIDED|95.0|0.63|1.61|||Regression, Logistic|||Week 24||1.61|0.63|0.968
91626637|NCT03906136|183145513|SUPERIORITY||Odds Ratio (OR)|0.3||||0.205|TWO_SIDED|95.0|-0.16|0.75|||Regression, Logistic|||Week 12||0.75|-0.16|0.205
91626638|NCT03906136|183145513|SUPERIORITY||Odds Ratio (OR)|0.37||||0.108|TWO_SIDED|95.0|-0.08|0.82|||Regression, Logistic|||Week 24||0.82|-0.08|0.108
91626639|NCT03906136|183145514|SUPERIORITY||Mean Difference (Net)|0.06||||0.525|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Week 12||0.23|-0.12|0.525
91626640|NCT03906136|183145514|SUPERIORITY||Mean Difference (Net)|-0.06||||0.577|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 24||0.14|-0.25|0.577
91663336|NCT00950989|183221990|SUPERIORITY||LS Mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.459|TWO_SIDED|95.0|-0.7|0.3||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.3|-0.7|0.459
91663337|NCT00950989|183221990|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.906|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.906
91663338|NCT00950989|183221990|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.849|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.849
91626641|NCT03906136|183145515|SUPERIORITY||Odds Ratio (OR)|-0.89||||0.22|TWO_SIDED|95.0|-2.32|0.54|||Mixed Models Analysis|||Week 12||0.54|-2.32|0.220
91626642|NCT03906136|183145515|SUPERIORITY||Median Difference (Net)|-0.1||||0.745|TWO_SIDED|95.0|-0.7|0.5|||Regression, Logistic|||Week 24||0.50|-0.70|0.745
91626643|NCT03906136|183145516|SUPERIORITY||Mean Difference (Net)|-0.13||||0.768|TWO_SIDED|95.0|-1.01|0.74|||Mixed Models Analysis|||Week 12||0.74|-1.01|0.768
91663339|NCT03804983|183221995|OTHER|Analysis of Variance||||||0.178||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.178
91663340|NCT03804983|183221996|OTHER|Analysis of Variance||||||0.145||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.145
91663341|NCT03804983|183221997|OTHER|Analysis of Variance||||||0.304||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.304
91663342|NCT03804983|183221998|OTHER|Analysis of Variance||||||0.131||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.131
91663343|NCT03804983|183222000|OTHER|Analysis of Variance||||||0.206||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.206
91663344|NCT03804983|183222001|OTHER|Analysis of Variance||||||0.335||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.335
91663345|NCT03804983|183222002|OTHER|Analysis of Variance||||||0.637||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.637
91663346|NCT03804983|183222003|OTHER|Analysis of Variance||||||0.347||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.347
91663347|NCT03804983|183222004|OTHER|Analysis of Variance||||||0.057||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.057
91482251|NCT03981822|182838327|SUPERIORITY|||||||0.0367|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0367
91626644|NCT03906136|183145516|SUPERIORITY||Mean Difference (Net)|-0.37||||0.451|TWO_SIDED|95.0|-1.34|0.6|||Mixed Models Analysis|||Week 24||0.60|-1.34|0.451
91626645|NCT03906136|183145517|SUPERIORITY||Mean Difference (Net)|0.26||||0.477|TWO_SIDED|95.0|-0.46|0.97|||Mixed Models Analysis|||Week 12||0.97|-0.46|0.477
91626646|NCT03906136|183145517|SUPERIORITY||Mean Difference (Net)|-0.17||||0.66|TWO_SIDED|95.0|-0.92|0.58|||Mixed Models Analysis|||Week 24||0.58|-0.92|0.660
91626647|NCT03906136|183145518|SUPERIORITY||Mean Difference (Net)|0.17||||0.586|TWO_SIDED|95.0|-0.45|0.79|||Mixed Models Analysis|||Week 12||0.79|-0.45|0.586
91626648|NCT03906136|183145518|SUPERIORITY||Median Difference (Net)|0.21||||0.491|TWO_SIDED|95.0|-0.39|0.82|||Mixed Models Analysis|||Week 24||0.82|-0.39|0.491
91482252|NCT03981822|182838327|SUPERIORITY|||||||0.1746|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.1746
91626649|NCT03906136|183145519|SUPERIORITY|Week 12|Mean Difference (Net)|4.49||||0.082|TWO_SIDED|95.0|-0.58|9.56|||Mixed Models Analysis|||||9.56|-0.58|0.082
91626650|NCT03906136|183145519|SUPERIORITY||Median Difference (Net)|2.73||||0.292|TWO_SIDED|95.0|-2.35|7.81|||Mixed Models Analysis|||Week 24||7.81|-2.35|0.292
91626651|NCT00878644|183145525|SUPERIORITY||Risk Difference (RD)|7.3||||0.14|TWO_SIDED|95.0|-1.5|16.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||16.1|-1.5|0.14
91626652|NCT00878644|183145526|SUPERIORITY||Risk Difference (RD)|9.1||||0.13|TWO_SIDED|95.0|-1.8|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||19.9|-1.8|0.13
91663348|NCT03804983|183222005|OTHER|Analysis of Variance||||||0.435||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.435
91663349|NCT03804983|183222006|OTHER|Analysis of Variance||||||0.135||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.135
91663350|NCT03804983|183222007|OTHER|Analysis of Variance||||||0.271||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.271
91663351|NCT03804983|183222008|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
91663352|NCT03804983|183222010|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
91691916|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9952||95.0|-1.06|1.07|||ANCOVA|Model terms include treatment, study center, and baseline score.||Cycle 7.||1.07|-1.06|0.9952
91691917|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.6265||95.0|-0.85|1.38|||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8.||1.38|-0.85|0.6265
91663353|NCT03804983|183222011|OTHER|Analysis of Variance||||||0.294||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.294
91663354|NCT03804983|183222012|OTHER|Analysis of Variance||||||0.584||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.584
91663355|NCT03804983|183222013|OTHER|Analysis of Variance||||||0.69||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.69
91663356|NCT03804983|183222014|OTHER|Analysis of Variance||||||0.066||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.066
91663357|NCT03804983|183222015|OTHER|Analysis of Variance||||||0.904||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.904
91663358|NCT00424047|183222066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.001|TWO_SIDED|95.0|0.24|0.438|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)|||0.438|0.240|<0.001
91714049|NCT00810069|183319700|SUPERIORITY_OR_OTHER||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.7||0.597|TWO_SIDED|95.0|-1.74|1.0||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||1.00|-1.74|0.597
91714050|NCT00810069|183319700|SUPERIORITY_OR_OTHER||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.74||0.36|TWO_SIDED|95.0|-2.13|0.78||P-value for Week 12: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.78|-2.13|0.360
91714051|NCT00810069|183319700|SUPERIORITY_OR_OTHER||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.81||0.937|TWO_SIDED|95.0|-1.52|1.65||P-value for Week 16: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||1.65|-1.52|0.937
91714052|NCT00810069|183319701|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Kaplan-Meier estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.075
91663359|NCT00424047|183222067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.105|TWO_SIDED|95.0|0.498|1.07|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)|||1.070|0.498|0.105
91663360|NCT00424047|183222068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.302|TWO_SIDED|95.0|0.651|1.143|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.143|0.651|0.302
91663361|NCT00424047|183222069|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
91663362|NCT00424047|183222070|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
91663363|NCT00424047|183222073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.558||||0.021|TWO_SIDED|95.0|0.338|0.921|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).|||0.921|0.338|0.021
91663364|NCT00424047|183222074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.362|||<|0.001|TWO_SIDED|95.0|0.27|0.478||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.478|0.27|<0.001
91663365|NCT00424047|183222075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.166||||0.271|TWO_SIDED|95.0|0.887|1.532||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)|||1.532|0.887|0.271
91663366|NCT00424047|183222076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.135||||0.359|TWO_SIDED|95.0|0.866|1.486||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.486|0.866|0.359
91663367|NCT00424047|183222077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.032|TWO_SIDED|95.0|0.398|0.964|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.964|0.398|0.032
91663368|NCT01229150|183222086|SUPERIORITY_OR_OTHER|||||||0.24|||||||Log Rank|||||||0.24
91663369|NCT01229150|183222086|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||0.75
91663370|NCT01229150|183222090|SUPERIORITY_OR_OTHER|||||||0.51|||||||Log Rank|||||||0.51
91663371|NCT01229150|183222090|SUPERIORITY_OR_OTHER|||||||0.81|||||||Log Rank|||||||0.81
91527789|NCT01678820|182930630|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.95|-0.28|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-0.28|-0.95|<0.001
91626653|NCT00878644|183145527|SUPERIORITY|||||||0.13|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.13
91626654|NCT00878644|183145528|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.81
91663372|NCT01229150|183222092|SUPERIORITY_OR_OTHER||||||<|0.0007||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.|Wilcoxon matched-pairs signed rank test|||||||<0.0007
91663373|NCT01229150|183222092|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||||||<0.0001
91663374|NCT01229150|183222092|SUPERIORITY_OR_OTHER|||||||0.0209||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||4 patients in this group; statistically underpowered.||||0.0209
91663375|NCT03100344|183222111|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward-Rogers|||||0.0|-27.3|0.051
91663376|NCT03100344|183222111|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||||-3.2|-30.2|0.016
91663377|NCT03100344|183222111|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||||6.8|-20.5|0.322
91663378|NCT03100344|183222112|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.034|TWO_SIDED|95.0|2.0|35.8|||Cochran-Mantel-Haenszel|||||35.8|2.0|0.034
91663379|NCT03100344|183222112|SUPERIORITY||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|14.7|48.2|||Cochran-Mantel-Haenszel|||||48.2|14.7|<0.001
91663380|NCT03100344|183222112|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.154|TWO_SIDED|95.0|-4.2|28.6|||Cochran-Mantel-Haenszel|||||28.6|-4.2|0.154
91663381|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|10.9||||0.062|TWO_SIDED|95.0|-0.4|22.2|||Cochran-Mantel-Haenszel|||Week 1||22.2|-0.4|0.062
91663382|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.042|TWO_SIDED|95.0|0.8|23.6|||Cochran-Mantel-Haenszel|||Week 1||23.6|0.8|0.042
91663383|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.307|TWO_SIDED|95.0|-4.7|15.0|||Cochran-Mantel-Haenszel|||Week 1||15.0|-4.7|0.307
91663384|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.003|TWO_SIDED|95.0|9.3|38.7|||Cochran-Mantel-Haenszel|||Week 2||38.7|9.3|0.003
91663385|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.001|TWO_SIDED|95.0|11.4|40.9|||Cochran-Mantel-Haenszel|||Week 2||40.9|11.4|0.001
91663386|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.011|TWO_SIDED|95.0|4.9|33.1|||Cochran-Mantel-Haenszel|||Week 2||33.1|4.9|0.011
91663387|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|27.6|||<|0.001|TWO_SIDED|95.0|13.5|41.7|||Cochran-Mantel-Haenszel|||Week 4||41.7|13.5|<0.001
91663388|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|40.3|||<|0.001|TWO_SIDED|95.0|25.7|54.8|||Cochran-Mantel-Haenszel|||Week 4||54.8|25.7|<0.001
91663389|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|31.6|||<|0.001|TWO_SIDED|95.0|17.4|45.8|||Cochran-Mantel-Haenszel|||Week 4||45.8|17.4|<0.001
91663390|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.018|TWO_SIDED|95.0|4.2|37.1|||Cochran-Mantel-Haenszel|||Week 8||37.1|4.2|0.018
91663391|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|1|TWO_SIDED|95.0|27.6|59.9|||Cochran-Mantel-Haenszel|||Week 8||59.9|27.6|<0001
91663392|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|9.7|42.6|||Cochran-Mantel-Haenszel|||Week 8||42.6|9.7|0.003
91663393|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.007|TWO_SIDED|95.0|7.3|41.4|||Cochran-Mantel-Haenszel|||Week 12||41.4|7.3|0.007
91663394|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|43.6|||<|0.001|TWO_SIDED|95.0|27.4|59.9|||Cochran-Mantel-Haenszel|||Week 12||59.9|27.4|<0.001
91663395|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.03|TWO_SIDED|95.0|2.4|35.9|||Cochran-Mantel-Haenszel|||Week 12||35.9|2.4|0.030
91663396|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.4|50.2|||Cochran-Mantel-Haenszel|||Week 16||50.2|16.4|<0.001
91663397|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|47.2|||<|0.001|TWO_SIDED|95.0|31.2|63.2|||Cochran-Mantel-Haenszel|||Week 16||63.2|31.2|<0.001
91663398|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|22.8||||0.01|TWO_SIDED|95.0|6.1|39.4|||Cochran-Mantel-Haenszel|||Week 16||39.4|6.1|0.010
91663399|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|26.3||||0.004|TWO_SIDED|95.0|9.2|43.5|||Cochran-Mantel-Haenszel|||Week 20||43.5|9.2|0.004
91663400|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|36.7|||<|0.001|TWO_SIDED|95.0|20.1|53.3|||Cochran-Mantel-Haenszel|||Week 20||53.3|20.1|<0.001
91663401|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.007|TWO_SIDED|95.0|7.6|41.4|||Cochran-Mantel-Haenszel|||Week 20||41.4|7.6|0.007
91663402|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.022|TWO_SIDED|95.0|3.6|38.1|||Cochran-Mantel-Haenszel|||Week 24||38.1|3.6|0.022
91626655|NCT01696396|183145529|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.|Odds Ratio (OR)|1.15||||0.76|TWO_SIDED|90.0|0.54|2.44|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.44|0.54|0.76
91626656|NCT01696396|183145529|SUPERIORITY||Difference in Adjusted Remission Rates|1.6|||||TWO_SIDED|90.0|-7.9|8.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.9|-7.9|
91626657|NCT01696396|183145529|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|90.0|0.8|4.57|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.57|0.80|0.22
91663403|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|24.3||||0.007|TWO_SIDED|95.0|7.4|41.3|||Cochran-Mantel-Haenszel|||Week 24||41.3|7.4|0.007
91663404|NCT03100344|183222113|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.05|TWO_SIDED|95.0|0.4|34.4|||Cochran-Mantel-Haenszel|||Week 24||34.4|0.4|0.050
91663405|NCT03100344|183222114|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-14.4||||0.017|TWO_SIDED|95.0|-26.2|-2.7|||Kenward Roger|||||-2.7|-26.2|0.017
91663406|NCT03100344|183222114|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-11.3||||0.058|TWO_SIDED|95.0|-23.1|0.4|||Kenward Roger|||||0.4|-23.1|0.058
91663407|NCT03100344|183222114|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-20.0|||<|0.001|TWO_SIDED|95.0|-31.6|-8.3|||Kenward Roger|||||-8.3|-31.6|<0.001
91663408|NCT03100344|183222115|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-9.6||||0.016|TWO_SIDED|95.0|-17.5|-1.8|||Kenward Roger|||||-1.8|-17.5|0.016
91663409|NCT03100344|183222115|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-12.8||||0.001|TWO_SIDED|95.0|-20.6|-5.1|||Kenward Roger|||||-5.1|-20.6|0.001
91663410|NCT03100344|183222115|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-7.6||||0.058|TWO_SIDED|95.0|-15.4|0.3|||Kenward Roger|||||0.3|-15.4|0.058
91663411|NCT03100344|183222116|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-24.5|||<|0.001|TWO_SIDED|95.0|-37.8|-11.2|||Kenward Roger|||||-11.2|-37.8|<0.001
91663412|NCT03100344|183222116|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-31.7|||<|0.001|TWO_SIDED|95.0|-44.9|-18.6|||Kenward Roger|||||-18.6|-44.9|<0.001
91663413|NCT03100344|183222116|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-25.1|||<|0.001|TWO_SIDED|95.0|-38.4|-11.8|||Kenward Roger|||||-11.8|-38.4|<0.001
91663414|NCT03100344|183222117|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.0|||<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||Kenward Roger|||||-1.0|-3.1|<0.001
91663415|NCT03100344|183222117|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.3|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Kenward Roger|||||-1.3|-3.4|<0.001
91663416|NCT03100344|183222117|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||||-0.9|-3.0|<0.001
91663417|NCT03100344|183222118|OTHER||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||At week 1||5.1|-4.9|0.970
91663418|NCT03100344|183222118|OTHER||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||At week 1||7.5|-4.1|0.574
91663419|NCT03100344|183222118|OTHER||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||At week 1||1.7|-5.2|0.311
91663420|NCT03100344|183222118|OTHER||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||At week 24||19.8|-11.3|0.598
91663421|NCT03100344|183222118|OTHER||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||At week 24||31.4|-0.4|0.066
91663422|NCT03100344|183222118|OTHER||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||At week 24||16.9|-13.5|0.826
91663423|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
91663424|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
91663425|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
91663426|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
91663427|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
91663428|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
91663429|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
91663430|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
91663431|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
91663432|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
91626658|NCT01696396|183145529|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|9.1|||||TWO_SIDED|90.0|-4.6|19.4||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||19.4|-4.6|
91626659|NCT01696396|183145529|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.05||||0.25|TWO_SIDED|90.0|0.74|5.73|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.73|0.74|0.25
91626660|NCT01696396|183145529|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|10.3|||||TWO_SIDED|90.0|-6.8|22.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-6.8|
91663433|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
91482253|NCT03981822|182838327|SUPERIORITY|||||||0.0123|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.0123
91482254|NCT03981822|182838328|SUPERIORITY||LS mean difference|-3.96||||0.0021|TWO_SIDED|95.0|-5.41|-1.24||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-1.24|-5.41|0.0021
91626661|NCT01696396|183145530|SUPERIORITY||Odds Ratio (OR)|1.78||||0.16|TWO_SIDED|90.0|0.9|3.53|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.53|0.90|0.16
91626662|NCT01696396|183145530|SUPERIORITY||Difference in Adjusted Remission Rates|10.9|||||TWO_SIDED|90.0|-1.8|21.0||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||21.0|-1.8|
91626663|NCT01696396|183145530|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.12||||0.13|TWO_SIDED|90.0|0.93|4.84|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.84|0.93|0.13
91626664|NCT01696396|183145530|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|14.7|||||TWO_SIDED|90.0|-2.1|27.5||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.5|-2.1|
91626665|NCT01696396|183145530|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.1||||0.056|TWO_SIDED|90.0|1.17|8.2|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.20|1.17|0.056
91626666|NCT01696396|183145530|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|23.7|||||TWO_SIDED|90.0|2.8|39.2||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||39.2|2.8|
91626667|NCT01696396|183145531|SUPERIORITY||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|90.0|1.27|4.01|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.01|1.27|0.021
91626668|NCT01696396|183145531|SUPERIORITY||Difference in Adjusted Response Rates|19.8|||||TWO_SIDED|90.0|5.8|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|5.8|
91626669|NCT01696396|183145531|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.9||||0.14|TWO_SIDED|90.0|0.94|3.87|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.87|0.94|0.14
91626670|NCT01696396|183145531|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.7|||||TWO_SIDED|90.0|-2.3|29.7||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||29.7|-2.3|
91663434|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.032|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 12||28.2|-0.3|0.032
91663435|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
91714053|NCT00810069|183319702|SUPERIORITY_OR_OTHER||Survival rate difference|-0.07||||0.116|TWO_SIDED|95.0|-0.16|0.02||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan-Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.02|-0.16|0.116
91626671|NCT01696396|183145531|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|90.0|0.79|4.39|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.39|0.79|0.23
91714054|NCT00186485|183319717|SUPERIORITY_OR_OTHER||||||<|0.001||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the HAM-D rating scale: total scores (F (4,96) = 19.88, p \< .001) over the 4 week treatment period.|ANOVA|Repeated Measures Anova||ANOVA with partial eta accounts for multiple repeated measures over the course of treatment.||||<0.001
91482255|NCT03981822|182838328|SUPERIORITY||LS mean difference|-4.72||||0.015|TWO_SIDED|95.0|-5.95|-0.66|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-0.66|-5.95|0.0150
91626672|NCT01696396|183145531|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.1|||||TWO_SIDED|90.0|-6.4|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|-6.4|
91626673|NCT01696396|183145532|SUPERIORITY||Odds Ratio (OR)|1.98||||0.047|TWO_SIDED|90.0|1.13|3.47|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.47|1.13|0.047
91626674|NCT01696396|183145532|SUPERIORITY||Difference in Adjusted Response Rates|16.0|||||TWO_SIDED|90.0|2.4|27.1||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.1|2.4|
91626675|NCT01696396|183145532|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|90.0|0.52|2.29|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.29|0.52|0.84
91626676|NCT01696396|183145532|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|1.9|||||TWO_SIDED|90.0|-15.2|15.2||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||15.2|-15.2|
91626677|NCT01696396|183145532|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.15||||0.78|TWO_SIDED|90.0|0.49|2.72|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.72|0.49|0.78
91527790|NCT01678820|182930631|SUPERIORITY_OR_OTHER||Difference in least squares means|1.7||||0.856|TWO_SIDED|95.0|-17.1|20.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||20.6|-17.1|0.856
91626678|NCT01696396|183145532|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|3.1|||||TWO_SIDED|90.0|-17.4|18.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||18.3|-17.4|
91626679|NCT01696396|183145533|SUPERIORITY||Odds Ratio (OR)|1.65||||0.34|TWO_SIDED|90.0|0.69|3.91|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.91|0.69|0.34
91626680|NCT01696396|183145533|SUPERIORITY||Difference in Adjusted Remission Rates|5.0|||||TWO_SIDED|90.0|-3.9|11.7||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.7|-3.9|
91626681|NCT01696396|183145533|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.82||||0.078|TWO_SIDED|90.0|1.07|7.41|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.41|1.07|0.078
91663436|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
91663437|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
91663438|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
91663439|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
91663440|NCT03100344|183222118|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
91714055|NCT00186485|183319718|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the BDI total scores (F (4,96) = 19.35, p \< .001) over the 4 week treatment period.,|ANOVA|||Repeated measures ANOVA with partial eta; accounts for multiple repeated measures over the course of treatment.||||<0.01
91714056|NCT00186485|183319719|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the CGI scores (F (4,88) = 5.31, p \< .01) over the 4 week treatment period.|ANOVA|||Repeated Measures ANOVA with partial eta; p value was adjusted for multiple comparisons over the course of treatment||||<0.01
91626682|NCT01696396|183145533|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|12.8|||||TWO_SIDED|90.0|-0.6|22.6||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-0.6|
91626683|NCT01696396|183145533|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.37||||0.083|TWO_SIDED|90.0|1.07|10.66|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.66|1.07|0.083
91626684|NCT01696396|183145533|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|16.0|||||TWO_SIDED|90.0|-1.2|28.3||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||28.3|-1.2|
91626685|NCT01696396|183145534|SUPERIORITY||Odds Ratio (OR)|1.52||||0.47|TWO_SIDED|90.0|0.59|3.93|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.93|0.59|0.47
91626686|NCT01696396|183145534|SUPERIORITY||Difference in Adjusted Remission Rates|2.8|||||TWO_SIDED|90.0|-4.7|8.1||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.1|-4.7|
91626687|NCT01696396|183145534|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.32||||0.21|TWO_SIDED|90.0|0.77|6.98|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.98|0.77|0.21
91663441|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.487|TWO_SIDED|95.0|-6.8|14.3|||Cochran-Mantel-Haenszel|||Week 1||14.3|-6.8|0.487
91663442|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.6|26.5|||Cochran-Mantel-Haenszel|||Week 1||26.5|1.6|0.033
91663443|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.053|TWO_SIDED|95.0|0.2|23.8|||Cochran-Mantel-Haenszel|||Week 1||23.8|0.2|0.053
91663444|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|18.5||||0.021|TWO_SIDED|95.0|3.2|33.8|||Cochran-Mantel-Haenszel|||Week 2||33.8|3.2|0.021
91663445|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.027|TWO_SIDED|95.0|2.4|32.3|||Cochran-Mantel-Haenszel|||Week 2||32.3|2.4|0.027
91663446|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|22.7||||0.006|TWO_SIDED|95.0|7.3|38.1|||Cochran-Mantel-Haenszel|||Week 2||38.1|7.3|0.006
91527791|NCT01678820|182930631|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.2||||0.002|TWO_SIDED|95.0|-47.9|-10.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-10.6|-47.9|0.002
91663447|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.086|TWO_SIDED|95.0|-1.7|32.2|||Cochran-Mantel-Haenszel|||Week 4||32.2|-1.7|0.086
91663448|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.004|TWO_SIDED|95.0|9.3|43.1|||Cochran-Mantel-Haenszel|||Week 4||43.1|9.3|0.004
91663449|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.05|TWO_SIDED|95.0|0.5|34.2|||Cochran-Mantel-Haenszel|||Week 4||34.2|0.5|0.050
91663450|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.023|TWO_SIDED|95.0|3.3|38.1|||Cochran-Mantel-Haenszel|||Week 8||38.1|3.3|0.023
91663451|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
91714057|NCT01922258|183319727|SUPERIORITY||Treatment Difference|-2.34|||=|0.1454|TWO_SIDED|95.0|-5.49|0.82|||Mixed-effect model repeated measure|||||0.82|-5.49|=0.1454
91714058|NCT01261390|183319736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.677|STANDARD_ERROR_OF_MEAN|1.652|||TWO_SIDED|95.0|-5.915|0.561|||||Presented average of the treatment effects on 24hr SBP at 6months and 12months: (6mo + 12mo)/ 2; Comparison: ActivePAP Control. Adjusted for randomization factors (CVD; site; sleepstudy type) with subjectspecific slopes and intercepts.|"We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint\* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε"||0.561|-5.915|
91482256|NCT03981822|182838328|SUPERIORITY||LS mean difference|-5.31||||0.0011|TWO_SIDED|95.0|-6.54|-1.69||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-1.69|-6.54|0.0011
91482257|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.5||||0.0007|TWO_SIDED|95.0|-8.25|-2.32||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||-2.32|-8.25|0.0007
91714059|NCT01261390|183319737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.0||||0.003|TWO_SIDED||||||Mixed Models Analysis|Adjusted for intervention and study duration (number of nights), and randomization (CVD; site; diagnostic sleep study type; PAP device type).|Estimated value is minutes of use per night.|We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).||||0.003
91714060|NCT02782741|183319779|NON_INFERIORITY|NI was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference of avalglucosidase alfa minus alglucosidase alfa was greater than (\>) -1.1.|LS mean difference|2.43|STANDARD_ERROR_OF_MEAN|1.29||0.0074|TWO_SIDED|95.0|-0.13|4.99|||mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||4.99|-0.13|0.0074
91482258|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.15||||0.0012|TWO_SIDED|95.0|-7.5|-1.91||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-1.91|-7.50|0.0012
91626688|NCT01696396|183145534|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|6.8|||||TWO_SIDED|90.0|-4.3|14.5||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.5|-4.3|
91626689|NCT01696396|183145534|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.66||||0.21|TWO_SIDED|90.0|0.75|9.45|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.45|0.75|0.21
91626690|NCT01696396|183145534|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|8.4|||||TWO_SIDED|90.0|-6.0|17.9||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||17.9|-6.0|
91626691|NCT01696396|183145535|SUPERIORITY||LS Mean Treatment Difference|-42.09||||0.006|TWO_SIDED|90.0|-67.3|-16.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-16.9|-67.3|0.006
91626692|NCT01696396|183145535|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-40.79||||0.095|TWO_SIDED|90.0|-81.5|-0.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-0.5|-81.5|0.095
91626693|NCT01696396|183145535|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-36.84||||0.11|TWO_SIDED|90.0|-74.3|0.7|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||0.7|-74.3|0.11
91626694|NCT01696396|183145536|SUPERIORITY||LS Mean Treatment Difference|-27.47||||0.045|TWO_SIDED|90.0|-50.0|-4.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-4.9|-50.0|0.045
91626695|NCT01696396|183145536|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-23.59||||0.27|TWO_SIDED|90.0|-58.7|11.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||11.5|-58.7|0.27
91482259|NCT03981822|182838328|SUPERIORITY||LS mean difference|-5.02||||0.0349|TWO_SIDED|95.0|-6.78|-0.26||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-0.26|-6.78|0.0349
91626696|NCT01696396|183145536|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-16.37||||0.45|TWO_SIDED|90.0|-51.8|19.1|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||19.1|-51.8|0.45
91626697|NCT00394277|183145542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.075||||0.584||95.0|0.831|1.391||All secondary comparisons were tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.||1.391|0.831|0.584
91626698|NCT00394277|183145543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.039||||0.775||95.0|0.803|1.344||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.344|0.803|0.775
91626699|NCT00394277|183145544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.004||||0.973||95.0|0.777|1.299||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.299|0.777|0.973
91626700|NCT00394277|183145545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.951||95.0|0.78|1.304||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.304|0.780|0.951
91626701|NCT02371980|183145546|SUPERIORITY||Hazard Ratio (HR)|0.517||||0.006|TWO_SIDED|95.0|0.323|0.828||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.828|0.323|0.006
91626702|NCT02371980|183145546|SUPERIORITY||Hazard Ratio (HR)|0.476||||0.002|TWO_SIDED|95.0|0.296|0.767||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.767|0.296|0.002
91626703|NCT02371980|183145546|SUPERIORITY||Hazard Ratio (HR)|0.483||||0.003|TWO_SIDED|95.0|0.298|0.782||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.782|0.298|0.003
91626704|NCT02371980|183145547|SUPERIORITY||Least Squares Mean (LSM) Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.421|TWO_SIDED|95.0|-1.63|0.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.68|-1.63|0.421
91626705|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.589||0.037|TWO_SIDED|95.0|-2.39|-0.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||-0.08|-2.39|0.037
91626706|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.592||0.488|TWO_SIDED|95.0|-1.57|0.75|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.75|-1.57|0.488
91626707|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.765||0.002|TWO_SIDED|95.0|-3.93|-0.93|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.93|-3.93|0.002
91626708|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.761|<|0.001|TWO_SIDED|95.0|-4.49|-1.51|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-1.51|-4.49|<0.001
91626709|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.775||0.001|TWO_SIDED|95.0|-4.02|-0.98|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.98|-4.02|0.001
91663452|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
91663453|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|19.3||||0.041|TWO_SIDED|95.0|1.3|37.3|||Cochran-Mantel-Haenszel|||Week 12||37.3|1.3|0.041
91482260|NCT03981822|182838328|SUPERIORITY||LS mean difference|-4.76|||<|0.0001|TWO_SIDED|95.0|-7.47|-2.85||P-value is based on MMRM mode|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.||-2.85|-7.47|<0.0001
91663454|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.003|TWO_SIDED|95.0|10.4|45.4|||Cochran-Mantel-Haenszel|||Week 12||45.4|10.4|0.003
91482261|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.0||||0.0005|TWO_SIDED|95.0|-8.37|-2.43||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.||-2.43|-8.37|0.0005
91482262|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.64|||<|0.0001|TWO_SIDED|95.0|-9.65|-4.12||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.||-4.12|-9.65|<0.0001
91626710|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|0.924||0.001|TWO_SIDED|95.0|-4.76|-1.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.13|-4.76|0.001
91626711|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.919|<|0.001|TWO_SIDED|95.0|-5.64|-2.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-2.03|-5.64|<0.001
91626712|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.939||0.001|TWO_SIDED|95.0|-4.84|-1.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.16|-4.84|0.001
91626713|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.92|STANDARD_ERROR_OF_MEAN|0.938||0.002|TWO_SIDED|95.0|-4.76|-1.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.08|-4.76|0.002
91626714|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-4.51|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-6.34|-2.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-2.68|-6.34|<0.001
91626715|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.949|<|0.001|TWO_SIDED|95.0|-5.5|-1.78|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.78|-5.50|<0.001
91626716|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.957||0.033|TWO_SIDED|95.0|-3.92|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.16|-3.92|0.033
91626717|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.69|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-5.55|-1.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-1.82|-5.55|<0.001
91626718|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.967||0.007|TWO_SIDED|95.0|-4.52|-0.73|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.73|-4.52|0.007
91626719|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.912||0.004|TWO_SIDED|95.0|-4.4|-0.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.82|-4.40|0.004
91626720|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.906|<|0.001|TWO_SIDED|95.0|-5.86|-2.31|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-2.31|-5.86|<0.001
91626721|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.921||0.003|TWO_SIDED|95.0|-4.57|-0.96|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.96|-4.57|0.003
91626722|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|1.008||0.057|TWO_SIDED|95.0|-3.89|0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.06|-3.89|0.057
91626723|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.997|<|0.001|TWO_SIDED|95.0|-5.46|-1.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-1.55|-5.46|<0.001
91626724|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.011||0.012|TWO_SIDED|95.0|-4.51|-0.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.55|-4.51|0.012
91626725|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.012||0.061|TWO_SIDED|95.0|-3.88|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.09|-3.88|0.061
91482263|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.49||||0.0004|TWO_SIDED|95.0|-9.67|-2.92||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-2.92|-9.67|0.0004
91626726|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-2.36|STANDARD_ERROR_OF_MEAN|0.997||0.018|TWO_SIDED|95.0|-4.31|-0.4|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||-0.40|-4.31|0.018
91527792|NCT01678820|182930632|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.6|||<|0.001|TWO_SIDED|95.0|-35.6|-15.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-15.6|-35.6|<0.001
91626727|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.015||0.065|TWO_SIDED|95.0|-3.87|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.12|-3.87|0.065
91626728|NCT02371980|183145547|SUPERIORITY||MMRM Model|-3.09|STANDARD_ERROR_OF_MEAN|1.136||0.007|TWO_SIDED|95.0|-5.31|-0.86|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.86|-5.31|0.007
91626729|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.97|STANDARD_ERROR_OF_MEAN|1.122|<|0.001|TWO_SIDED|95.0|-6.16|-1.77|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.77|-6.16|<0.001
91626730|NCT02371980|183145547|SUPERIORITY||Least Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.143||0.002|TWO_SIDED|95.0|-5.82|-1.34|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.34|-5.82|0.002
91626731|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.085||0.732|TWO_SIDED|95.0|-0.2|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.14|-0.20|0.732
91626732|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.273|TWO_SIDED|95.0|-0.26|0.07|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.07|-0.26|0.273
91626733|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.085||0.361|TWO_SIDED|95.0|-0.24|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.09|-0.24|0.361
91626734|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.099||0.004|TWO_SIDED|95.0|-0.48|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.09|-0.48|0.004
91626735|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.099||0.002|TWO_SIDED|95.0|-0.5|-0.12|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.12|-0.50|0.002
91626736|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.16|-0.55|<0.001
91626737|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.121||0.014|TWO_SIDED|95.0|-0.54|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.06|-0.54|0.014
91626738|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.121||0.001|TWO_SIDED|95.0|-0.63|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.16|-0.63|0.001
91626739|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.123||0.002|TWO_SIDED|95.0|-0.62|-0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.14|-0.62|0.002
91626740|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.025|TWO_SIDED|95.0|-0.51|-0.03|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.03|-0.51|0.025
91626741|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.74|-0.26|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.26|-0.74|<0.001
91626742|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.124||0.002|TWO_SIDED|95.0|-0.63|-0.15|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.15|-0.63|0.002
91626743|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.123||0.333|TWO_SIDED|95.0|-0.36|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||0.12|-0.36|0.333
91626744|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.122||0.002|TWO_SIDED|95.0|-0.61|-0.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.13|-0.61|0.002
91626745|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.124||0.023|TWO_SIDED|95.0|-0.53|-0.04|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.04|-0.53|0.023
91626746|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.092|TWO_SIDED|95.0|-0.44|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||0.03|-0.44|0.092
91663455|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.063|TWO_SIDED|95.0|-0.5|35.2|||Cochran-Mantel-Haenszel|||Week 12||35.2|-0.5|0.063
91663456|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 16||35.6|-0.4|0.064
91663457|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|22.6||||0.016|TWO_SIDED|95.0|4.9|40.3|||Cochran-Mantel-Haenszel|||Week 16||40.3|4.9|0.016
91663458|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.041|TWO_SIDED|95.0|1.3|36.9|||Cochran-Mantel-Haenszel|||Week 16||36.9|1.3|0.041
91663459|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 20||35.6|-0.4|0.064
91663460|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.005|TWO_SIDED|95.0|8.6|43.4|||Cochran-Mantel-Haenszel|||Week 20||43.4|8.6|0.005
91663461|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.064|TWO_SIDED|95.0|-0.6|35.0|||Cochran-Mantel-Haenszel|||Week 20||35.0|-0.6|0.064
91663462|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|15.9||||0.094|TWO_SIDED|95.0|-2.0|33.8|||Cochran-Mantel-Haenszel|||Week 24||33.8|-2.0|0.094
91482264|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.89|-3.57||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-3.57|-9.89|<0.0001
91482265|NCT03981822|182838328|SUPERIORITY||LS mean difference|-6.99||||0.0005|TWO_SIDED|95.0|-10.2|-2.94||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-2.94|-10.20|0.0005
91527793|NCT01678820|182930632|SUPERIORITY_OR_OTHER||Difference in least squares means|5.3||||0.286|TWO_SIDED|95.0|-4.5|15.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||15.2|-4.5|0.286
91663463|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.014|TWO_SIDED|95.0|5.1|39.6|||Cochran-Mantel-Haenszel|||Week 24||39.6|5.1|0.014
91663464|NCT03100344|183222119|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.273|TWO_SIDED|95.0|-7.7|28.0|||Cochran-Mantel-Haenszel|||Week 24||28.0|-7.7|0.273
91663465|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.979|TWO_SIDED|95.0|-6.8|7.0|||Cochran-Mantel-Haenszel|||Week 1||7.0|-6.8|0.979
91663466|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.668|TWO_SIDED|95.0|-5.8|9.0|||Cochran-Mantel-Haenszel|||Week 1||9.0|-5.8|0.668
91663467|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.8|9.2|||Cochran-Mantel-Haenszel|||Week 1||9.2|-5.8|0.658
91663468|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.69|TWO_SIDED|95.0|-8.0|12.2|||Cochran-Mantel-Haenszel|||Week 2||12.2|-8.0|0.690
91663469|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.521|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel|||Week 2||13.7|-6.9|0.521
91663470|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.5|26.5|||Cochran-Mantel-Haenszel|||Week 2||26.5|1.5|0.033
91663471|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.172|TWO_SIDED|95.0|-3.1|18.0|||Cochran-Mantel-Haenszel|||Week 4||18.0|-3.1|0.172
91663472|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.014|TWO_SIDED|95.0|3.7|27.7|||Cochran-Mantel-Haenszel|||Week 4||27.7|3.7|0.014
91663473|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.002|TWO_SIDED|95.0|8.2|33.9|||Cochran-Mantel-Haenszel|||Week 4||33.9|8.2|0.002
91663474|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.404|TWO_SIDED|95.0|-7.5|18.8|||Cochran-Mantel-Haenszel|||Week 8||18.8|-7.5|0.404
91663475|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.003|TWO_SIDED|95.0|9.4|39.6|||Cochran-Mantel-Haenszel|||Week 8||39.6|9.4|0.003
91663476|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|14.1||||0.059|TWO_SIDED|95.0|-0.1|28.2|||Cochran-Mantel-Haenszel|||Week 8||28.2|-0.1|0.059
91663477|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.222|TWO_SIDED|95.0|-5.6|25.0|||Cochran-Mantel-Haenszel|||Week 12||25.0|-5.6|0.222
91663478|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|10.0|42.3|||Cochran-Mantel-Haenszel|||Week 12||42.3|10.0|0.003
91663479|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.22|TWO_SIDED|95.0|3.3|35.0|||Cochran-Mantel-Haenszel|||Week 12||35.0|3.3|0.22
91663480|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|13.3||||0.111|TWO_SIDED|95.0|-2.8|29.3|||Cochran-Mantel-Haenszel|||Week 16||29.3|-2.8|0.111
91663481|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|13.2|46.0|||Cochran-Mantel-Haenszel|||Week 16||46.0|13.2|<0.001
91663482|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.04|TWO_SIDED|95.0|1.3|33.6|||Cochran-Mantel-Haenszel|||Week 16||33.6|1.3|0.040
91663483|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.262|TWO_SIDED|95.0|-7.3|27.4|||Cochran-Mantel-Haenszel|||Week 20||27.4|-7.3|0.262
91663484|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.327|TWO_SIDED|95.0|-8.4|25.7|||Cochran-Mantel-Haenszel|||Week 20||25.7|-8.4|0.327
91663485|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.083|TWO_SIDED|95.0|-1.7|33.1|||Cochran-Mantel-Haenszel|||Week 20||33.1|-1.7|0.083
91663486|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.255|TWO_SIDED|95.0|-7.0|27.2|||Cochran-Mantel-Haenszel|||Week 24||27.2|-7.0|0.255
91663487|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.034|TWO_SIDED|95.0|2.2|35.9|||Cochran-Mantel-Haenszel|||Week 24||35.9|2.2|0.034
91663488|NCT03100344|183222120|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.053|TWO_SIDED|95.0|0.3|34.6|||Cochran-Mantel-Haenszel|||Week 24||34.6|0.3|0.053
91663489|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
91714061|NCT02782741|183319779|SUPERIORITY|A test for superiority of avalglucosidase alfa versus alglucosidase alfa was performed with an overall 5% level of significance.||||||0.0626||||||Threshold for significance at \<0.05 level.|mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||||0.0626
91482266|NCT03981822|182838329|SUPERIORITY||LS mean difference|-41.47|||<|0.0001|TWO_SIDED|95.0|-51.31|-20.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-20.87|-51.31|<0.0001
91626747|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.121|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.20|-0.67|<0.001
91626748|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.122||0.008|TWO_SIDED|95.0|-0.57|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.09|-0.57|0.008
91626749|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.248|TWO_SIDED|95.0|-0.42|0.11|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.11|-0.42|0.248
91626750|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.133||0.006|TWO_SIDED|95.0|-0.63|-0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.10|-0.63|0.006
91626751|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.087|TWO_SIDED|95.0|-0.5|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.03|-0.50|0.087
91626752|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.131||0.362|TWO_SIDED|95.0|-0.38|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.38|0.362
91626753|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.251|TWO_SIDED|95.0|-0.4|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.10|-0.40|0.251
91626754|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.131||0.391|TWO_SIDED|95.0|-0.37|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.37|0.391
91626755|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.141||0.209|TWO_SIDED|95.0|-0.45|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||0.10|-0.45|0.209
91626756|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|-0.6|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.06|-0.60|0.018
91626757|NCT02371980|183145548|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.141||0.009|TWO_SIDED|95.0|-0.65|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.09|-0.65|0.009
91626758|NCT02371980|183145550|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.002|TWO_SIDED|95.0|0.302|0.766||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.766|0.302|0.002
91626759|NCT02371980|183145550|SUPERIORITY||Hazard Ratio (HR)|0.455|||<|0.001|TWO_SIDED|95.0|0.286|0.725||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.725|0.286|<0.001
91626760|NCT02371980|183145550|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.002|TWO_SIDED|95.0|0.304|0.771||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.771|0.304|0.002
91626761|NCT01280812|183145552|SUPERIORITY||Median Difference (Net)|1100.0|STANDARD_DEVIATION|3000.0|||TWO_SIDED|95.0|||||Mixed Models Analysis|Two-sided P values less than .05 were considered statistically significant.||Intent to treat analysis||||
91626762|NCT01060098|183145558|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.003
91626763|NCT01060098|183145558|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.04
91626764|NCT01060098|183145558|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.48
91626765|NCT00789724|183145559|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
91626766|NCT01594749|183145568|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
91663490|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
91626767|NCT01594749|183145569|SUPERIORITY_OR_OTHER||Difference in percentage vs. Control|0.6||||0.085|TWO_SIDED|95.0|-0.2|1.7||P-value based on Miettinen \& Nurminen method|Miettinen & Nurminen method|||||1.7|-0.2|0.085
91626768|NCT01594749|183145571|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
91626769|NCT01594749|183145572|SUPERIORITY_OR_OTHER|||||||0.184||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||0.184
91626770|NCT01594749|183145573|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
91626771|NCT00922974|183145600|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Based on the one-sided exact binomial test with α=0.025 and a 2:1 randomization, 228 patients would be required to detect a 40% improvement in the response rate from 51% (external beam radiation therapy) to 70% (Radiosurgery/SBRT) with a statistical power of 0.80.||||0.99
91626772|NCT00922974|183145601|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|95.0|0.72|1.27|||Stratified log rank|One-sided significance level = 0.025.|Reference level = Radiosurgery/SBRT|||1.27|0.72|0.38
91626773|NCT00922974|183145602|SUPERIORITY||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.24|12.8|||Stratified log rank|One-sided significance level = 0.025|Significance level = Radiosurgery/SBRT|||12.8|0.24|0.29
91626774|NCT00922974|183145603|SUPERIORITY|||||||0.93||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with treatment-related adverse events.||||0.93
91626775|NCT00922974|183145603|SUPERIORITY|||||||0.09||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with any adverse events.||||0.09
91626776|NCT00922974|183145604|SUPERIORITY|||||||0.59||||||Two-sided significance level = 0.05|Gray's test|||||||0.59
91626777|NCT00922974|183145605|SUPERIORITY|||||||0.38||||||Two-sided significance level = 0.05|Gray's test|||||||0.38
91626778|NCT00922974|183145606|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Assuming that the data are normally distributed, the two sample t-test assuming equal variances will be used to test the hypothesis at the one-sided 0.025 significance level. A mean difference of 7 points represents a clinically meaningful change (CMC). A difference of less than 7 points between the treatment arms will not be considered meaningful, even if it has statistical significance.||||0.28
91663491|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-4.8|4.8|||Cochran-Mantel-Haenszel|||Week 1||4.8|-4.8|0.985
91663492|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.154|TWO_SIDED|95.0|-8.4|1.2|||Cochran-Mantel-Haenszel|||Week 2||1.2|-8.4|0.154
91663493|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
91663494|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
91663495|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.602|TWO_SIDED|95.0|-7.5|4.3|||Cochran-Mantel-Haenszel|||Week 4||4.3|-7.5|0.602
91663496|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.5|11.4|||Cochran-Mantel-Haenszel|||Week 4||11.4|-4.5|0.413
91663497|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.7|9.1|||Cochran-Mantel-Haenszel|||Week 4||9.1|-5.7|0.658
91663498|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.307|TWO_SIDED|95.0|-3.2|10.3|||Cochran-Mantel-Haenszel|||Week 8||10.3|-3.2|0.307
91663499|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.002|TWO_SIDED|95.0|6.9|27.8|||Cochran-Mantel-Haenszel|||Week 8||27.8|6.9|0.002
91663500|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.054|TWO_SIDED|95.0|0.1|17.4|||Cochran-Mantel-Haenszel|||Week 8||17.4|0.1|0.054
91663501|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.325|TWO_SIDED|95.0|-5.4|16.5|||Cochran-Mantel-Haenszel|||Week 12||16.5|-5.4|0.325
91663502|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.019|TWO_SIDED|95.0|3.1|28.1|||Cochran-Mantel-Haenszel|||Week 12||28.1|3.1|0.019
91663503|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.011|TWO_SIDED|95.0|4.5|30.5|||Cochran-Mantel-Haenszel|||Week 12||30.5|4.5|0.011
91663504|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|9.2||||0.153|TWO_SIDED|95.0|-3.2|21.7|||Cochran-Mantel-Haenszel|||Week 16||21.7|-3.2|0.153
91663505|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|||Week 16||38.4|10.3|0.001
91663506|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.069|TWO_SIDED|95.0|-0.7|25.1|||Cochran-Mantel-Haenszel|||Week 16||25.1|-0.7|0.069
91663507|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|12.9||||0.07|TWO_SIDED|95.0|-0.8|26.6|||Cochran-Mantel-Haenszel|||Week 20||26.6|-0.8|0.070
91663508|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.006|TWO_SIDED|95.0|6.5|35.3|||Cochran-Mantel-Haenszel|||Week 20||35.3|6.5|0.006
91663509|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.052|TWO_SIDED|95.0|0.3|27.7|||Cochran-Mantel-Haenszel|||Week 20||27.7|0.3|0.052
91663510|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.069|TWO_SIDED|95.0|-0.7|26.3|||Cochran-Mantel-Haenszel|||Week 24||26.3|-0.7|0.069
91663511|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.011|TWO_SIDED|95.0|4.9|33.3|||Cochran-Mantel-Haenszel|||Week 24||33.3|4.9|0.011
91663512|NCT03100344|183222121|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.083|TWO_SIDED|95.0|-1.3|25.7|||Cochran-Mantel-Haenszel|||Week 24||25.7|-1.3|0.083
91663513|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
91663514|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
91663515|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||Week 1||1.7|-5.2|0.311
91663516|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
91663517|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
91663518|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
91663519|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
91792046|NCT01857310|183461832|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.8|1.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||1.0|-0.8|
91626779|NCT00922974|183145607|SUPERIORITY|||||||0.4313|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.4313
91626780|NCT00922974|183145607|SUPERIORITY|||||||0.8707|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.8707
91626781|NCT00922974|183145607|SUPERIORITY|||||||0.1549|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.1549
91626782|NCT00922974|183145607|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.0193
91626783|NCT00922974|183145607|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0016
91626784|NCT00922974|183145607|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0003
91663520|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
91663521|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
91663522|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
91792047|NCT01857310|183461832|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.53|2.21|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||2.21|0.53|
91792048|NCT01857310|183461833|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||1.3|-0.4|
91663523|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
91663524|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
91663525|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
91663526|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
91663527|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.032|TWO_SIDED|95.0|1.8|29.5|||Cochran-Mantel-Haenszel|||Week 12||29.5|1.8|0.032
91663528|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
91663529|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
91663530|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
91663531|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
91626785|NCT00922974|183145607|SUPERIORITY|||||||0.6371|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.6371
91626786|NCT00922974|183145608|SUPERIORITY|||||||0.0218|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.0218
91626787|NCT00922974|183145608|SUPERIORITY|||||||0.9437|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.9437
91626788|NCT00922974|183145608|SUPERIORITY|||||||0.0696|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0696
91626789|NCT00922974|183145608|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.1140
91626790|NCT00922974|183145608|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0003
91626791|NCT00922974|183145608|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||<0.0001
91626792|NCT00922974|183145608|SUPERIORITY|||||||0.7732|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.7732
91626793|NCT00922974|183145609|SUPERIORITY|||||||0.5198|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.5198
91626794|NCT00922974|183145609|SUPERIORITY|||||||0.1197|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.1197
91626795|NCT00922974|183145609|SUPERIORITY|||||||0.0306|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0306
91626796|NCT00922974|183145609|SUPERIORITY|||||||0.7903|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.7903
91626797|NCT00922974|183145609|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||<0.0001
91626798|NCT00922974|183145609|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0026
91482267|NCT03981822|182838329|SUPERIORITY||LS mean difference|-50.95||||0.0004|TWO_SIDED|95.0|-66.18|-19.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-19.56|-66.18|0.0004
91626799|NCT00922974|183145609|SUPERIORITY|||||||0.3282|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.3282
91626800|NCT00191386|183145613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 6 Months|Paired t-test|||||||<0.001
91482268|NCT03981822|182838329|SUPERIORITY||LS mean difference|-66.21|||<|0.0001|TWO_SIDED|95.0|-88.15|-35.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-35.87|-88.15|<0.0001
91482269|NCT03981822|182838329|SUPERIORITY||LS mean difference|-79.37|||<|0.0001|TWO_SIDED|95.0|-111.44|-49.77||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-49.77|-111.44|<0.0001
91482270|NCT03981822|182838329|SUPERIORITY||LS mean difference|-69.79||||0.0001|TWO_SIDED|95.0|-103.17|-35.25||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.||-35.25|-103.17|0.0001
91626801|NCT00191386|183145613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 12 Months|Paired t-test|||||||<0.001
91626802|NCT00191386|183145613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 2 Years.|Paired t-test|||||||<0.001
91626803|NCT00191386|183145613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 3 Years.|Paired t-test|||||||<0.001
91626804|NCT00191386|183145613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 4 Years.|Paired t-test|||||||<0.001
91663532|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
91663533|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
91482271|NCT03981822|182838329|SUPERIORITY||LS mean difference|-41.22||||0.1033|TWO_SIDED|95.0|-90.61|8.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||8.56|-90.61|0.1033
91626805|NCT00191386|183145614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 6 Months.|Paired t-test|||||||<0.001
91626806|NCT00191386|183145614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 12 Months.|Paired t-test|||||||<0.001
91626807|NCT00191386|183145614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 2 Years.|Paired t-test|||||||<0.001
91626808|NCT00191386|183145614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 3 Years.|Paired t-test|||||||<0.001
91626809|NCT00191386|183145614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 4 Years.|Paired t-test|||||||<0.001
91626810|NCT02574481|183145630|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
91626811|NCT02574481|183145631|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions..|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
91626812|NCT00446641|183145644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.654||95.0|||||Chi-squared|||We assumed that the prevalence of AR would be 12 % among ischemic stroke patients who were treated with aspirin 100 per day. The prevalence could be reduced to 4% with additional cilostazol therapy||||0.654
91626813|NCT05302804|183145682|SUPERIORITY|||||||0.742||||||p-value reflects main effect of treatment.|ANOVA|||"Null hypothesis was there was no difference between menthol gel and control gel~time x trial ANOVA statistical analysis"||||0.742
91626814|NCT05302804|183145683|SUPERIORITY|||||||0.742||||||p-value is main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.742
91626815|NCT05302804|183145684|SUPERIORITY|||||||0.048||||||p-value reflects main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.048
91626816|NCT05302804|183145685|SUPERIORITY|||||||0.104|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.104
91626817|NCT05302804|183145686|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.051
91626818|NCT05302804|183145687|SUPERIORITY||||||<|0.001||||||Main effect of treatment|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||< 0.001
91663534|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||Week 24||19.8|-11.3|0.598
91663535|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||Week 24||31.4|-0.4|0.066
91663536|NCT03100344|183222122|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||Week 24||16.9|-13.5|0.826
91663537|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-10.0||||0.049|TWO_SIDED|95.0|-20.0|0.0|||Kenward-Rogers|||Week 1||0.0|-20.0|0.049
91626819|NCT05302804|183145688|SUPERIORITY|||||||0.026|||||||ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.026
91626820|NCT05302804|183145689|SUPERIORITY|||||||0.001||||||p-value at time 30 min of exercise|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.001
91626821|NCT05302804|183145690|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91626822|NCT02038790|183145693|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||>0.5000
91527794|NCT01678820|182930633|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1|||<|0.001|TWO_SIDED|95.0|-24.2|-12.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.0|-24.2|<0.001
91626823|NCT02038790|183145694|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0196
91626824|NCT02038790|183145695|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0006
91626825|NCT02038790|183145696|SUPERIORITY_OR_OTHER|||||||0.4422|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.4422
91626826|NCT02038790|183145697|SUPERIORITY_OR_OTHER|||||||0.2377|TWO_SIDED||||||Chi-squared|||||||0.2377
91626827|NCT02038790|183145698|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Chi-squared|||||||0.0603
91626828|NCT02038790|183145699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.0010
91626829|NCT02009930|183145823|OTHER||Wilson Method used|16.0|||||TWO_SIDED|95.0|9.4|22.9||||||||22.9|9.4|
91663538|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-16.9|||<|0.001|TWO_SIDED|95.0|-26.7|-7.0|||Kenward Roger|||Week 1||-7.0|-26.7|<0.001
91663539|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-15.7||||0.002|TWO_SIDED|95.0|-25.6|-5.8|||Kenward Roger|||Week 1||-5.8|-25.6|0.002
91626830|NCT02009930|183145824|OTHER||||||||||||||||||Only descriptive statistics were calculated (frequency, percent). Inferential statistics were not necessary, nor appropriate|||
91626831|NCT02009930|183145825|OTHER|||||||0.79||||||Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor expressed as a p-value|Spearman's Rank Correlation Coefficient|Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor. Spearman's rho = 0.04||Compare risk categories (FRS and CAC)||||0.79
91626832|NCT02009930|183145826|OTHER|||||||0.063||||||Relationship between FRS and metabolic syndrome. FRS risk category (low, mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||FRS risk category (low, mod, mod-high, high, very high risk)||||0.063
91626833|NCT02009930|183145826|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
91626834|NCT02009930|183145827|OTHER|||||||0.56||||||Relationship between FRS and living in the dorms. FRS risk category (low, mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||FRS risk categories (low, moderate, mod -high, high, and very high)||||0.56
91626835|NCT02009930|183145827|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
91626836|NCT02009930|183145828|OTHER|||||||0.44||||||Relationship between FRS and PT failures. FRS risk category (low, mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, PT failure - with/without PT failure) expressed as a p-value||FRS risk categories (low, moderate, moderate-high, high, and very high)||||0.44
91626837|NCT02009930|183145828|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
91626838|NCT02009930|183145829|OTHER|||||||0.11||||||Relationship between FRS and overall years of service. FRS risk category (low, mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, overall years of service) expressed as a p-value||FRS risk categories (low, moderate, moderate -high, high, and very high)||||0.11
91626839|NCT02009930|183145829|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
91663540|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-9.8||||0.084|TWO_SIDED|95.0|-20.9|1.3|||Kenward Roger|||Week 2||1.3|-20.9|0.084
91663541|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-16.2||||0.004|TWO_SIDED|95.0|-27.2|-5.2|||Kenward Roger|||Week 2||-5.2|-27.2|0.004
91663542|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-14.8||||0.008|TWO_SIDED|95.0|-25.8|-3.8|||Kenward Roger|||Week 2||-3.8|-25.8|0.008
91663543|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-14.0||||0.044|TWO_SIDED|95.0|-27.5|-0.4|||Kenward Roger|||Week 4||-0.4|-27.5|0.044
91482272|NCT03981822|182838329|SUPERIORITY||LS mean difference|-58.43|||<|0.0001|TWO_SIDED|95.0|-73.26|-39.39||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-39.39|-73.26|<0.0001
91482273|NCT03981822|182838329|SUPERIORITY||LS mean difference|-69.86|||<|0.0001|TWO_SIDED|95.0|-81.61|-28.8||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-28.80|-81.61|<0.0001
91482274|NCT03981822|182838329|SUPERIORITY||LS mean difference|-76.55|||<|0.0001|TWO_SIDED|95.0|-107.19|-45.61||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-45.61|-107.19|<0.0001
91482275|NCT03981822|182838329|SUPERIORITY||LS mean difference|-74.29||||0.0003|TWO_SIDED|95.0|-102.96|-31.55||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-31.55|-102.96|0.0003
91482276|NCT03981822|182838329|SUPERIORITY||LS mean difference|-77.1||||0.0004|TWO_SIDED|95.0|-110.32|-32.78||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-32.78|-110.32|0.0004
91482277|NCT03981822|182838329|SUPERIORITY||LS mean difference|-77.52||||0.0178|TWO_SIDED|95.0|-120.82|-11.88||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-11.88|-120.82|0.0178
91626840|NCT02009930|183145831|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
91663544|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-21.1||||0.002|TWO_SIDED|95.0|-34.7|-7.6|||Kenward Roger|||Week 4||-7.6|-34.7|0.002
91663545|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-15.3||||0.026|TWO_SIDED|95.0|-28.8|-1.8|||Kenward Roger|||Week 4||-1.8|-28.8|0.026
91663546|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-14.8||||0.062|TWO_SIDED|95.0|-30.2|0.7|||Kenward Roger|||Week 8||0.7|-30.2|0.062
91482278|NCT03981822|182838330|SUPERIORITY|||||||0.0004||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0004
91626841|NCT02009930|183145832|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
91626842|NCT02009930|183145833|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
91626843|NCT02009930|183145834|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
91626844|NCT03300427|183145842|SUPERIORITY||difference in least square means|-900.0||||0.7594|TWO_SIDED|95.0|-6781.7|4981.8|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||4981.8|-6781.7|0.7594
91626845|NCT03300427|183145844|SUPERIORITY||difference in least square means|-575.5||||0.8422|TWO_SIDED|95.0|-6365.5|5214.5|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||5214.5|-6365.5|0.8422
91626846|NCT00879437|183145857|NON_INFERIORITY|if 19 evaluable patients enrolled for DIPG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control if 21 evaluable patients enrolled for HGG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control|||||<|0.05|||||||Log Rank|one sample log-rank||comparing 1-year EFS of DIPG on this trial versus historical control (1-year EFS of 17% from CCG-9941; PMID 12177103) comparing 1-year EFS of HGG on this trial versus historical control (1-year EFS of 36% from ACNS0126; PMID 21339192)||||< 0.05
91626847|NCT00879437|183145897|OTHER|The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals.|||
91626848|NCT00879437|183145898|OTHER|The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals.|||
91626849|NCT00879437|183145899|OTHER|||||||||||||||||partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter)|Not applicable (8 partial responses in 16 patients = 50%)|||
91626850|NCT01001234|183145904|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|95.0|1.06|2.26||The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.|Regression, Logistic|Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.||The comparison of rizatriptan versus placebo with respect to the primary outcome was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (United States \[US\] or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.26|1.06|0.025
91663547|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-23.4||||0.003|TWO_SIDED|95.0|-38.9|-7.9|||Kenward Roger|||Week 8||-7.9|-38.9|0.003
91663548|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-20.6||||0.009|TWO_SIDED|95.0|-36.0|-5.2|||Kenward Roger|||Week 8||-5.2|-36.0|0.009
91663549|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-15.9||||0.022|TWO_SIDED|95.0|-29.4|-2.3|||Kenward Roger|||Week 12||-2.3|-29.4|0.022
91663550|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-23.7|||<|0.001|TWO_SIDED|95.0|-37.1|-10.2|||Kenward Roger|||Week 12||-10.2|-37.1|<0.001
91663551|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-14.7||||0.032|TWO_SIDED|95.0|-28.1|-1.3|||Kenward Roger|||Week 12||-1.3|-28.1|0.032
91663552|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-13.7||||0.07|TWO_SIDED|95.0|-28.6|1.1|||Kenward Roger|||Week 16||1.1|-28.6|0.070
91714062|NCT02782741|183319780|SUPERIORITY|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|30.01|STANDARD_ERROR_OF_MEAN|14.43||0.0405|TWO_SIDED|95.0|1.33|58.69|||mixed model for repeated measures|||LS mean difference was derived from MMRM model with baseline FVC (% predicted) and baseline 6MWT (distance walked in meter), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||58.69|1.33|0.0405
91482279|NCT03981822|182838330|SUPERIORITY|||||||0.0005||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0005
91626851|NCT01001234|183145905|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.9||Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.|Regression, Logistic|This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 12 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.90|0.96|0.080
91663553|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-23.7||||0.002|TWO_SIDED|95.0|-38.5|-8.9|||Kenward Roger|||Week 16||-8.9|-38.5|0.002
91663554|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-10.7||||0.154|TWO_SIDED|95.0|-25.6|4.1|||Kenward Roger|||Week 16||4.1|-25.6|0.154
91663555|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-12.1||||0.09|TWO_SIDED|95.0|-26.0|1.9|||Kenward Roger|||Week 20||1.9|-26.0|0.090
91663556|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-15.9||||0.024|TWO_SIDED|95.0|-29.7|-2.1|||Kenward Roger|||Week 20||-2.1|-29.7|0.024
91663557|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-9.5||||0.18|TWO_SIDED|95.0|-23.4|4.4|||Kenward Roger|||Week 20||4.4|-23.4|0.180
91663558|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward Roger|||Week 24||0.0|-27.3|0.051
91663559|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||Week 24||-3.2|-30.2|0.016
91663560|NCT03100344|183222123|SUPERIORITY||mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||Week 24||6.8|-20.5|0.322
91663561|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-10.9||||0.012|TWO_SIDED|95.0|-19.4|-2.4|||Kenward Roger|||Week 1||-2.4|-19.4|0.012
91663562|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-15.4|||<|0.001|TWO_SIDED|95.0|-23.8|-7.1|||Kenward Roger|||Week 1||-7.1|-23.8|<0.001
91663563|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-9.4||||0.029|TWO_SIDED|95.0|-17.8|-0.9|||Kenward Roger|||Week 1||-0.9|-17.8|0.029
91663564|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-21.8|||<|0.001|TWO_SIDED|95.0|-32.0|-11.6|||Kenward Roger|||Week 2||-11.6|-32.0|<0.001
91663565|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-29.1|||<|0.001|TWO_SIDED|95.0|-39.1|-19.1|||Kenward Roger|||Week 2||-19.1|-39.1|<0.001
91663566|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-34.0|-13.6|||Kenward Roger|||Week 2||-13.6|-34.0|<0.001
91663567|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-21.3|||<|0.001|TWO_SIDED|95.0|-32.1|-10.5|||Kenward Roger|||Week 4||-10.5|-32.1|<0.001
91663568|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-34.8|||<|0.001|TWO_SIDED|95.0|-45.5|-24.2|||Kenward Roger|||Week 4||-24.2|-45.5|<0.001
91663569|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-30.7|||<|0.001|TWO_SIDED|95.0|-41.6|-19.9|||Kenward Roger|||Week 4||-19.9|-41.6|<0.001
91663570|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-22.9|||<|0.001|TWO_SIDED|95.0|-33.2|-12.6|||Kenward Roger|||Week 8||-12.6|-33.2|<0.001
91792049|NCT01857310|183461833|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.68|3.32|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||3.32|0.68|
91626852|NCT01001234|183145906|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.01|TWO_SIDED|95.0|1.1|2.1||This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain freedom at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.10|1.10|0.010
91626853|NCT01001234|183145907|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.178|TWO_SIDED|95.0|0.91|1.63||This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.63|0.91|0.178
91482280|NCT03981822|182838330|SUPERIORITY|||||||0.0698||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0698
91626854|NCT01363258|183145908|OTHER|Generalized linear mixed models fitted with binomial (logit link) and gamma (log link) distributions, with additional dispersion parameters, were used to estimate and test intervention effects in terms of occurrence and intensity of CRBs, respectively. Inference was conducted in the link scale, but inverse-link estimates in the original scales (proportions and CRB scores, for the binomial and gamma models, respectively) were computed to facilitate interpretation.|Effect size|-0.16||||0.1433|TWO_SIDED||||||Time by group interaction test|||||||0.1433
91626855|NCT03238352|183145935|OTHER||Difference of Least Square mean|-1.22|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.657|-0.782|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Negative Control at Week 8 is a primary endpoint comparison.||-0.782|-1.657|<0.0001
91626856|NCT03238352|183145935|OTHER||Difference of Least Square mean|-1.28|STANDARD_ERROR_OF_MEAN|0.213|<|0.0001|TWO_SIDED|95.0|-1.705|-0.858|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.858|-1.705|<.0001
91626857|NCT03238352|183145935|OTHER||Difference of Least Square mean|-1.25|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.6|-0.901|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.||-0.901|-1.600|<0.0001
91626858|NCT03238352|183145936|OTHER||Diference of Least Square mean|37.46|STANDARD_ERROR_OF_MEAN|7.306|<|0.0004|TWO_SIDED|95.0|22.916|51.995||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||51.995|22.916|<0.0004
91626859|NCT03238352|183145936|OTHER||Diference of Least Square mean|49.88|STANDARD_ERROR_OF_MEAN|7.079|<|0.0001|TWO_SIDED|95.0|35.791|63.966||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||63.966|35.791|<.0001
91626860|NCT03238352|183145936|OTHER||Diference of Least Square mean|43.67|STANDARD_ERROR_OF_MEAN|5.862|<|0.0001|TWO_SIDED|95.0|32.001|55.334||P-value from Van Elteren test.|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model||55.334|32.001|<.0001
91626861|NCT04153929|183145955|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626862|NCT04153929|183145955|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91663571|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-37.3|||<|0.001|TWO_SIDED|95.0|-47.4|-27.2|||Kenward Roger|||Week 8||-27.2|-47.4|<0.001
91663572|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-34.1|||<|0.001|TWO_SIDED|95.0|-44.4|-23.8|||Kenward Roger|||Week 8||-23.8|-44.4|<0.001
91626863|NCT04153929|183145955|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626864|NCT04153929|183145955|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626865|NCT04153929|183145955|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626866|NCT04153929|183145955|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.46||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.46|-1.06|<0.0001
91792050|NCT01857310|183461834|SUPERIORITY||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-7.9|3.23||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Fertilization rate will be compared using generalized estimating equations accounting for multiple cycles per couple."||3.23|-7.90|
91482281|NCT03981822|182838330|SUPERIORITY|||||||0.01||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0100
91482282|NCT03981822|182838330|SUPERIORITY|||||||0.0101||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0101
91482283|NCT03981822|182838330|SUPERIORITY|||||||0.0077||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0077
91626867|NCT04153929|183145955|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.01||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.01|-1.60|<0.0001
91626868|NCT04153929|183145955|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.87|-1.26||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.26|-1.87|<0.0001
91626869|NCT04153929|183145955|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.1||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.10|-1.72|<0.0001
91626870|NCT04153929|183145955|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.78|-1.19||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.19|-1.78|<0.0001
91482284|NCT03981822|182838330|SUPERIORITY|||||||0.064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0640
91482285|NCT03981822|182838330|SUPERIORITY|||||||0.0045||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.||||0.0045
91482286|NCT03981822|182838330|SUPERIORITY|||||||0.284||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.2840
91482287|NCT03981822|182838330|SUPERIORITY|||||||0.0132||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0132
91482288|NCT03981822|182838330|SUPERIORITY|||||||0.4668||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.4668
91482289|NCT03981822|182838330|SUPERIORITY|||||||0.0064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.0064
91482290|NCT03981822|182838331|SUPERIORITY|||||||0.0364|||||||Mantel Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0364
91626871|NCT04153929|183145955|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.84|-1.22||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.22|-1.84|<0.0001
91663573|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-24.1|||<|0.001|TWO_SIDED|95.0|-35.6|-12.5|||Kenward Roger|||Week 12||-12.5|-35.6|<0.001
91482291|NCT03981822|182838331|SUPERIORITY|||||||0.0215|||||||Cochran-Mantel-Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0215
91482292|NCT03981822|182838332|SUPERIORITY||LS mean difference|-59.63||||0.1222|TWO_SIDED|95.0|-76.1|9.23||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.||9.23|-76.10|0.1222
91482293|NCT03981822|182838332|SUPERIORITY||LS mean difference|-69.51||||0.0403|TWO_SIDED|95.0|-81.3|-1.9||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.||-1.90|-81.30|0.0403
91482294|NCT03981822|182838332|SUPERIORITY||LS mean difference|-58.88||||0.0863|TWO_SIDED|95.0|-77.79|5.33||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||5.33|-77.79|0.0863
91482295|NCT03981822|182838332|SUPERIORITY||LS mean difference|-62.13||||0.0428|TWO_SIDED|95.0|-100.76|-1.73||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-1.73|-100.76|0.0428
91482296|NCT03981822|182838332|SUPERIORITY||LS mean difference|-71.93||||0.0084|TWO_SIDED|95.0|-110.46|-17.0||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-17.00|-110.46|0.0084
91663574|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-38.4|||<|0.001|TWO_SIDED|95.0|-49.7|-27.2|||Kenward Roger|||Week 12||-27.2|-49.7|<0.001
91482297|NCT03981822|182838332|SUPERIORITY||LS mean difference|-63.11||||0.0273|TWO_SIDED|95.0|-103.08|-6.35||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-6.35|-103.08|0.0273
91482298|NCT03981822|182838333|SUPERIORITY|Analysis is based on MMRM model|LS mean difference|-44.65||||0.3083|TWO_SIDED|95.0|-69.96|22.47|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||22.47|-69.96|0.3083
91482299|NCT03981822|182838333|SUPERIORITY||LS mean difference|-55.8||||0.1686|TWO_SIDED|95.0|-86.93|15.56||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||15.56|-86.93|0.1686
91482300|NCT03981822|182838333|SUPERIORITY||LS mean difference|-38.06||||0.2384|TWO_SIDED|95.0|-87.04|22.1||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||22.10|-87.04|0.2384
91482301|NCT03981822|182838333|SUPERIORITY||LS mean difference|-61.96||||0.0603|TWO_SIDED|95.0|-103.37|2.27||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||2.27|-103.37|0.0603
91663575|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-30.2|||<|0.001|TWO_SIDED|95.0|-41.7|-18.7|||Kenward Roger|||Week 12||-18.7|-41.7|<0.001
91663576|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-20.9|||<|0.001|TWO_SIDED|95.0|-32.8|-8.9|||Kenward Roger|||Week 16||-8.9|-32.8|<0.001
91792051|NCT01857310|183461835|SUPERIORITY||Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.33|0.11||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of good quality embryos will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.11|-0.33|
91626872|NCT04153929|183145956|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626873|NCT04153929|183145956|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91663577|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-34.3|||<|0.001|TWO_SIDED|95.0|-46.0|-22.6|||Kenward Roger|||Week 16||-22.6|-46.0|<0.001
91663578|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-28.7|||<|0.001|TWO_SIDED|95.0|-40.7|-16.8|||Kenward Roger|||Week 16||-16.8|-40.7|<0.001
91663579|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-21.1||||0.001|TWO_SIDED|95.0|-33.7|-8.4|||Kenward Roger|||Week 20||-8.4|-33.7|0.001
91663580|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-29.7|||<|0.001|TWO_SIDED|95.0|-42.1|-17.3|||Kenward Roger|||Week 20||-17.3|-42.1|<0.001
91663581|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-27.9|||<|0.001|TWO_SIDED|95.0|-40.6|-15.2|||Kenward Roger|||Week 20||-15.2|-40.6|<0.001
91663582|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-22.4||||0.002|TWO_SIDED|95.0|-36.1|-8.6|||Kenward Roger|||Week 24||-8.6|-36.1|0.002
91663583|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-31.5|||<|0.001|TWO_SIDED|95.0|-44.9|-18.0|||Kenward Roger|||Week 24||-18.0|-44.9|<0.001
91663584|NCT03100344|183222124|SUPERIORITY||mean difference of percentage changes|-30.0|||<|0.001|TWO_SIDED|95.0|-43.8|-16.2|||Kenward Roger|||Week 24||-16.2|-43.8|<0.001
91663585|NCT03100344|183222126|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-3.0|-1.0|||Kenward Roger|||Week 24||-1.0|-3.0|<0.001
91663586|NCT03100344|183222126|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.001|TWO_SIDED|95.0|-3.8|-1.8|||Kenward Roger|||Week 24||-1.8|-3.8|<0.001
91663587|NCT03100344|183222126|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.3|-1.3|||Kenward Roger|||Week 24||-1.3|-3.3|<0.001
91663588|NCT03100344|183222127|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||Week 24||-0.9|-3.0|<0.001
91663589|NCT03100344|183222127|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.6|-1.6|||Kenward Roger|||Week 24||-1.6|-3.6|<0.001
91663590|NCT03100344|183222127|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||Kenward Roger|||Week 24||-1.1|-3.1|<0.001
91663591|NCT03100344|183222128|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-37.7|-9.9|||Kenward Roger|||Week 24||-9.9|-37.7|<0.001
91792052|NCT01857310|183461836|SUPERIORITY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-6.66|4.05||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Proportion of good quality embryos on day 5 will be compared using generalized estimating equations accounting for multiple cycles per couple."||4.05|-6.66|
91527795|NCT01678820|182930633|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0||||0.99|TWO_SIDED|95.0|-6.0|6.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||6.0|-6.0|0.990
91663592|NCT03100344|183222128|SUPERIORITY||mean difference of percentage changes|-31.4|||<|0.001|TWO_SIDED|95.0|-45.0|-17.7|||Kenward Roger|||Week 24||-17.7|-45.0|<0.001
91663593|NCT03100344|183222128|SUPERIORITY||mean difference of percentage changes|-29.2|||<|0.001|TWO_SIDED|95.0|-43.2|-15.2|||Kenward Roger|||Week 24||-15.2|-43.2|<0.001
91663594|NCT04406194|183222162|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean Ratio|0.9684||||0|TWO_SIDED|90.0|0.94|0.9977|||ANOVA|||||0.9977|0.9400|0.0000
91663595|NCT04406194|183222163|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean Ratio|1.0555||||0.0155|TWO_SIDED|90.0|0.9292|1.1989|||ANOVA|||||1.1989|0.9292|0.0155
91663596|NCT04406194|183222164|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean Ratio|0.9719||||0|TWO_SIDED|90.0|0.944|1.0006|||ANOVA|||||1.0006|0.9440|0.0000
91663597|NCT02888756|183222167|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).||||0.14
91663598|NCT03264092|183222178|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.18|||||||Fisher Exact|||||||0.18
91663599|NCT03264092|183222179|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.41|||||||Fisher Exact|||||||0.41
91663600|NCT03264092|183222180|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.45|||||||Fisher Exact|||||||0.45
91663601|NCT00928057|183222186|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.506||||||The threshold for statistical significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% \|∆ Fru\|), with 95 % confidence intervals."||||0.506
91792053|NCT01857310|183461837|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.11|0.1||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos transferred will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.10|-0.11|
91482302|NCT03981822|182838333|SUPERIORITY||LS mean difference|-74.87||||0.0109|TWO_SIDED|95.0|-138.71|-18.83||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||-18.83|-138.71|0.0109
91626874|NCT04153929|183145956|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626875|NCT04153929|183145956|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626876|NCT04153929|183145956|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
91626877|NCT04153929|183145956|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.11||||0.2228|TWO_SIDED|95.0|-2.9|0.68||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.68|-2.90|0.2228
91663602|NCT00928057|183222186|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.878||||||The threshold for significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % \|∆ Fru\|, with 95% confidence intervals."||||0.878
91663603|NCT00928057|183222191|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance, or alpha, is 0.05.|t-test, 1 sided|||The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.||||0.019
91663604|NCT00928057|183222191|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||As described for the 4 vs. 5mm statistical analysis.||||<0.001
91527796|NCT01678820|182930634|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.2|||<|0.001|TWO_SIDED|95.0|-28.3|-12.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.2|-28.3|<0.001
91626878|NCT04153929|183145956|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.79|||<|0.0001|TWO_SIDED|95.0|-5.56|-2.01||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.01|-5.56|<0.0001
91792054|NCT01857310|183461838|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.23|0.18||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos cryopreserved will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.18|-0.23|
91792055|NCT01857310|183461839|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-45.4|21.2||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Sperm penetration percentage will be compared using generalized estimating equations accounting for multiple cycles per couple."||21.2|-45.4|
91792056|NCT01857310|183461840|SUPERIORITY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.16|0.03||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared with Poisson regression using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||0.03|-0.16|
91792057|NCT01857310|183461841|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.88|1.61|||||Fewer than 4 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.61|0.88|
91792058|NCT01857310|183461842|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.43|||||Fewer than 8 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.43|0.77|
91792059|NCT01857310|183461843|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.87|
91792060|NCT01857310|183461844|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.63|1.06|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.06|0.63|
91792061|NCT01857310|183461845|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||ICSI|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Method of fertilization will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.80|
91792062|NCT01857310|183461846|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Excellent or good quality|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Quality of embryos transferred will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.21|0.88|
91626879|NCT04153929|183145956|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.41|-3.81||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.81|-7.41|<0.0001
91626880|NCT04153929|183145956|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.12|-4.38||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.38|-8.12|<0.0001
91626881|NCT04153929|183145956|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.02|-4.47||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.47|-8.02|<0.0001
91792063|NCT01857310|183461847|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.74|7.43|||||Abnormal|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Chromosomal complement will be compared using generalized estimating equations accounting for multiple cycles per couple."||7.43|0.74|
91626882|NCT04153929|183145956|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.68|||<|0.0001|TWO_SIDED|95.0|-9.52|-5.83||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.83|-9.52|<0.0001
91626883|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.66||||0.4439|TWO_SIDED|95.0|-2.34|1.03||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.03|-2.34|0.4439
91626884|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.28||||0.0001|TWO_SIDED|95.0|-4.95|-1.61||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.61|-4.95|0.0001
91525303|NCT01213043|182925810|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin was: \[0.80, 1.25\]|Geometric Least Square Means Ratio|0.85|||<|0.0001|TWO_SIDED|90.0|0.83|0.88|||ANOVA|||Dose proportionality was analysed using an ANOVA model for the natural log-transformed AUC0-7days with treatment, period, and sequence as fixed effects and subject within sequence as a random effect. The treatment dose of 60 mg/kg was the reference treatment and 120 mg/kg was the test treatment. PK parameters in individual subjects for each treatment dose were dose normalized to 60mg/kg based on the actual dose administered at Week 8 or Week 18 (i.e., (AUC0-7days/Actual Dose in mg/kg)\*60mg/kg).||0.88|0.83|<0.0001
91525304|NCT02887989|182925821|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||.6570
91525305|NCT02887989|182925822|SUPERIORITY|||||||0.6339|||||||t-test, 2 sided|||||||.6339
91525306|NCT02110732|182925847|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
91525307|NCT02110732|182925848|SUPERIORITY||||||<|0.05|||||||Chi-squared||||Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level \<0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS.|||< 0.05
91525308|NCT02110732|182925849|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
91525309|NCT01588990|182925933|SUPERIORITY_OR_OTHER|||||||0.101|||||||Cox Proportional Hazards Model|||||||0.101
91525310|NCT01588990|182925945|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cox Proportional Hazards Model|||||||0.052
91525311|NCT01588990|182925946|SUPERIORITY_OR_OTHER|||||||0.797|||||||Cox Proportional Hazards Model|||||||0.797
91525312|NCT01588990|182925947|SUPERIORITY_OR_OTHER|||||||0.188|||||||Cox Proportional Hazards Model|||||||0.188
91525313|NCT01588990|182925948|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cox Proportional Hazards Model|||||||0.016
91525314|NCT02367716|182925958|OTHER|The mean change in QRS duration between Baseline and 6 months|Mean Difference (Final Values)|-13.9|STANDARD_DEVIATION|29.6|||TWO_SIDED|||||||||||||
91663605|NCT03206749|183222193|SUPERIORITY||Least Squares (LS) Mean Difference|29.5|||<|0.0001|TWO_SIDED|95.0|16.61|42.4|||ANCOVA|||||42.40|16.61|<0.0001
91663606|NCT03206749|183222194|SUPERIORITY||LS Mean Difference|28.53|||<|0.0001|TWO_SIDED|95.0|16.18|40.88|||ANCOVA|||||40.88|16.18|<0.0001
91663607|NCT03206749|183222195|SUPERIORITY||LS Mean Difference|62.79|||<|0.0001|TWO_SIDED|95.0|36.3|89.27|||ANCOVA|||||89.27|36.30|<0.0001
91525315|NCT01473381|182925959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.0073|TWO_SIDED|95.0|-4.3|-0.84||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.84|-4.30|0.0073
91525316|NCT01473381|182925959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.82||||0.0034|TWO_SIDED|95.0|-4.57|-1.06||P-value was adjusted for multiplicity.|Mixed-effect model|||||-1.06|-4.57|0.0034
91525317|NCT01473381|182925959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.002|TWO_SIDED|95.0|-4.48|-1.0||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-1.00|-4.48|0.0020
91525318|NCT01473381|182925960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.58|-0.13||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.13|-0.58|0.0073
91525319|NCT01473381|182925960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0097|TWO_SIDED|95.0|-0.55|-0.1||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.10|-0.55|0.0097
91525320|NCT01473381|182925960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0025|TWO_SIDED|95.0|-0.57|-0.12||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-0.12|-0.57|0.0025
91663608|NCT03206749|183222196|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0469|TWO_SIDED|95.0|1.01|2.16|||Regression, Cox|||||2.16|1.01|0.0469
91663609|NCT03206749|183222197|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.3294|TWO_SIDED|95.0|0.79|2.0|||Regression, Cox|||||2.00|0.79|0.3294
91663610|NCT03206749|183222198|SUPERIORITY|||||||0.2341|||||||Regression, Cox|||||||0.2341
91663611|NCT03206749|183222199|SUPERIORITY|||||||0.3358||||||0 - 24 hours|Cochran-Mantel-Haenszel|||||||0.3358
91663612|NCT03206749|183222199|SUPERIORITY|||||||0.0849||||||Greater than (\>) 24 - 48 hours|Cochran-Mantel-Haenszel|||||||0.0849
91663613|NCT03206749|183222200|SUPERIORITY|||||||0.0004||||||0 - 24 hours|Wilcoxon rank-sum test|||||||0.0004
91663614|NCT03206749|183222200|SUPERIORITY|||||||0.0035||||||\>24 - 48 hours|Wilcoxon rank-sum test|||||||0.0035
91482303|NCT03981822|182838333|SUPERIORITY||LS mean difference|-66.62||||0.0467|TWO_SIDED|95.0|-127.64|-0.99||Analysis is base on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-0.99|-127.64|0.0467
91525321|NCT01473381|182925961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.3563|TWO_SIDED|95.0|-3.9|10.9||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||10.9|-3.9|0.3563
91525322|NCT01473381|182925961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.1611|TWO_SIDED|95.0|-0.4|14.6||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||14.6|-0.4|0.1611
91525323|NCT01473381|182925961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.2672|TWO_SIDED|95.0|-2.7|12.2||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||12.2|-2.7|0.2672
91525324|NCT03802864|182925966|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91525325|NCT03802864|182925967|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
91525326|NCT03802864|182925968|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91663615|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.22|TWO_SIDED|95.0|0.322|1.302|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).||1.302|0.322|0.22
91663616|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.24|TWO_SIDED|95.0|0.322|1.301|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.301|0.322|0.24
91663617|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.83|TWO_SIDED|95.0|0.501|2.405|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.501|0.83
91663618|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074||||0.87|TWO_SIDED|95.0|0.49|2.356|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.356|0.490|0.87
91663619|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.96|TWO_SIDED|95.0|0.458|2.131|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.131|0.458|0.96
91663620|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.16|TWO_SIDED|95.0|0.289|1.212|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.212|0.289|0.16
91663621|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.035|TWO_SIDED|95.0|0.324|0.937|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.937|0.324|0.035
91663622|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.624||||0.07|TWO_SIDED|95.0|0.373|1.045|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.045|0.373|0.070
91663623|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.085||||0.79|TWO_SIDED|95.0|0.605|1.947|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.947|0.605|0.79
91482304|NCT01617148|182838347|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91482305|NCT01617148|182838348|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91482306|NCT01617148|182838349|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
91482307|NCT01617148|182838350|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
91482308|NCT03463031|182838374|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
91482309|NCT03463031|182838375|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Models Analysis|||||-0.3|-1.0|<0.001
91525327|NCT03802864|182925969|SUPERIORITY|||||||0.28|||||||Regression, Linear|||||||0.28
91525328|NCT03802864|182925970|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
91525329|NCT03802864|182925971|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91525330|NCT03802864|182925972|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91525331|NCT01641926|182925973|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-8.4|11.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (hepatitis B Virus \[HBV\] genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||11.6|-8.4|
91525332|NCT01641926|182925974|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-3.0|||||TWO_SIDED|95.0|-20.2|14.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||14.3|-20.2|
91663624|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.959||||0.99|TWO_SIDED|95.0|0.527|1.743|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.743|0.527|0.99
91663625|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.78|TWO_SIDED|95.0|0.488|1.593|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.593|0.488|0.78
91663626|NCT00205777|183222227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.036|TWO_SIDED|95.0|0.34|0.968|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.968|0.340|0.036
91663627|NCT00205777|183222228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.097|TWO_SIDED|95.0|0.339|1.099|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.099|0.339|0.097
91663628|NCT00205777|183222228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.645||||0.15|TWO_SIDED|95.0|0.361|1.151|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.151|0.361|0.15
91663629|NCT00205777|183222228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.83|TWO_SIDED|95.0|0.493|1.793|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.793|0.493|0.83
91663630|NCT00205777|183222228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.067|TWO_SIDED|95.0|0.435|1.019|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.019|0.435|0.067
91663631|NCT00205777|183222228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.014|TWO_SIDED|95.0|0.367|0.896|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.896|0.367|0.014
91663632|NCT00205777|183222228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.5|TWO_SIDED|95.0|0.71|1.885|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.885|0.710|0.50
91663633|NCT00205777|183222229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.085|TWO_SIDED|95.0|0.44|1.052|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.052|0.440|0.085
91663634|NCT00205777|183222229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.004|TWO_SIDED|95.0|0.434|0.857|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.857|0.434|0.004
91663635|NCT00205777|183222230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.621||||0.4|TWO_SIDED|95.0|0.203|1.903|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.903|0.203|0.40
91663636|NCT00205777|183222230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.504||||0.26|TWO_SIDED|95.0|0.151|1.676|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.676|0.151|0.26
91663637|NCT00205777|183222230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.33|TWO_SIDED|95.0|0.157|1.86|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.860|0.157|0.33
91663638|NCT00205777|183222230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.661||||0.49|TWO_SIDED|95.0|0.206|2.118|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.118|0.206|0.49
91663639|NCT00205777|183222230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.76|TWO_SIDED|95.0|0.305|2.37|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.370|0.305|0.76
91663640|NCT00205777|183222230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.238||||0.75|TWO_SIDED|95.0|0.332|4.616|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||4.616|0.332|0.75
91663641|NCT00205777|183222231|SUPERIORITY_OR_OTHER||Relative Risk|0.9|||||TWO_SIDED|95.0|0.38|2.15||||||Relative risk versus placebo was provided together with 95% CIs.||2.15|0.38|
91663642|NCT00205777|183222231|SUPERIORITY_OR_OTHER||Relative Risk|0.92|||||TWO_SIDED|95.0|0.39|2.21||||||Relative risk versus placebo was provided together with 95% CIs.||2.21|0.39|
91663643|NCT00205777|183222232|SUPERIORITY_OR_OTHER||Relative risk|1.01|||||TWO_SIDED|95.0|0.5|2.06||||||Relative risk versus placebo was provided together with 95% CIs.||2.06|0.5|
91663644|NCT00205777|183222233|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Log Rank|||||||0.57
91663645|NCT00205777|183222233|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Log Rank|||||||0.62
91663646|NCT00205777|183222233|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||||||0.72
91663647|NCT00205777|183222233|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Log Rank|||||||0.67
91663648|NCT00205777|183222233|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||||||0.89
91663649|NCT00205777|183222233|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Log Rank|||||||0.95
91663650|NCT00205777|183222234|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||||||0.29
91663651|NCT00205777|183222234|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||||||0.31
91663652|NCT00205777|183222234|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Log Rank|||||||0.94
91663653|NCT00205777|183222235|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Log Rank|||||||0.18
91663654|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.46
91663655|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.90
91663656|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.93
91663657|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.84
91482310|NCT03463031|182838376|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|< 0.001
91525333|NCT01641926|182925975|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.6|||||TWO_SIDED|95.0|-7.2|12.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||12.3|-7.2|
91663658|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.39
91663659|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.52
91663660|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.28
91663661|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.31
91663662|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.17
91663663|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.72
91663664|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.97
91663665|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.76
91663666|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.29
91663667|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.43
91663668|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.59
91482311|NCT03463031|182838377|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.233|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.1|-0.6|0.233
91663669|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.19
91663670|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.80
91663671|NCT00205777|183222239|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.11
91663672|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.012||||0.968|TWO_SIDED|95.0|0.79|1.296|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.296|0.790|0.968
91663673|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.846||||0.211|TWO_SIDED|95.0|0.652|1.097|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.097|0.652|0.211
91663674|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.191|TWO_SIDED|95.0|0.925|1.556|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.556|0.925|0.191
91663675|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.493|TWO_SIDED|95.0|0.566|3.497|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||3.497|0.566|0.493
91663676|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872||||0.82|TWO_SIDED|95.0|0.316|2.405|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.316|0.820
91663677|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.612||||0.371|TWO_SIDED|95.0|0.624|4.161|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||4.161|0.624|0.371
91663678|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.423|TWO_SIDED|95.0|0.776|1.861|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.861|0.776|0.423
91663679|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.936||||0.799|TWO_SIDED|95.0|0.587|1.491|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.491|0.587|0.799
91525334|NCT01641926|182925976|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.1|||||TWO_SIDED|95.0|-9.5|13.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||13.6|-9.5|
91663680|NCT00205777|183222240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.298|TWO_SIDED|95.0|0.818|2.002|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.002|0.818|0.298
91482312|NCT02117414|182838425|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|95.0|97.75|||A priori threshold for statistical significance was 0.025.|one-proportion binomial exact test|||The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.|||97.75|<0.0001
91626885|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.93|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.23||P-value is considered nominal|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.23|-6.62|<0.0001
91626886|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.76|||<|0.0001|TWO_SIDED|95.0|-7.53|-4.0||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.00|-7.53|<0.0001
91626887|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.44|||<|0.0001|TWO_SIDED|95.0|-7.11|-3.77||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.77|-7.11|<0.0001
91626888|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.05|||<|0.0001|TWO_SIDED|95.0|-8.79|-5.31||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.31|-8.79|<0.0001
91626889|NCT04153929|183145957|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.85|||<|0.0001|TWO_SIDED|95.0|-5.52|-2.18||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.18|-5.52|<0.0001
91626890|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.62||||0.7708|TWO_SIDED|95.0|-4.82|3.57||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||3.57|-4.82|0.7708
91626891|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.68||||0.7462|TWO_SIDED|95.0|-3.44|4.79||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||4.79|-3.44|0.7462
91626892|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.32||||0.1302|TWO_SIDED|95.0|-7.62|0.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.98|-7.62|0.1302
91663681|NCT00205777|183222241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.19|0.78|0.73
91482313|NCT02117414|182838426|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.2|||<|0.0001|ONE_SIDED|95.0|-3.8|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-3.8|<0.0001
91663682|NCT00205777|183222241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.71|TWO_SIDED|95.0|0.41|1.83|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.83|0.41|0.71
91663683|NCT00205777|183222241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.45|TWO_SIDED|95.0|0.8|1.66|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.66|0.80|0.45
91663684|NCT00205777|183222242|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANCOVA|||||||0.31
91663685|NCT00205777|183222242|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
91663686|NCT00205777|183222242|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANCOVA|||||||0.13
91663687|NCT00205777|183222242|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
91663688|NCT00205777|183222242|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
91663689|NCT00205777|183222243|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
91663690|NCT00205777|183222243|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
91663691|NCT00205777|183222244|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|||||||0.26
91663692|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).||||<0.001
91714063|NCT02782741|183319781|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|5.24||0.5522|TWO_SIDED|95.0|-7.31|13.57|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MIP % predicted adjusted for MIP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||13.57|-7.31|0.5522
91626893|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.61||||0.0414|TWO_SIDED|95.0|-9.03|-0.18||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.18|-9.03|0.0414
91626894|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.55||||0.2273|TWO_SIDED|95.0|-6.71|1.6||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.60|-6.71|0.2273
91663693|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663694|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663695|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663696|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663697|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.018
91663698|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663699|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663700|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663701|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663702|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663703|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663704|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663705|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663706|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663707|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.036
91663708|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.003
91663709|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.019
91663710|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663711|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.002
91663712|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91525335|NCT01641926|182925976|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|10.1|||||TWO_SIDED|95.0|-7.2|27.1||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||27.1|-7.2|
91626895|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-8.4||||0.0002|TWO_SIDED|95.0|-12.81|-3.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.98|-12.81|0.0002
91626896|NCT04153929|183145958|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.72||||0.1967|TWO_SIDED|95.0|-6.86|1.42||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.42|-6.86|0.1967
91626897|NCT04153929|183145959|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.28|5.2|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||5.20|0.28|
91626898|NCT04153929|183145959|OTHER||Odds Ratio (OR)|7.92|||||TWO_SIDED|95.0|2.43|25.74|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||25.74|2.43|
91626899|NCT04153929|183145959|OTHER||Odds Ratio (OR)|17.68|||||TWO_SIDED|95.0|5.21|60.03|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||60.03|5.21|
91626900|NCT04153929|183145959|OTHER||Odds Ratio (OR)|25.87|||||TWO_SIDED|95.0|7.31|91.55|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||91.55|7.31|
91626901|NCT04153929|183145959|OTHER||Odds Ratio (OR)|21.75|||||TWO_SIDED|95.0|6.57|72.04|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||72.04|6.57|
91626902|NCT04153929|183145959|OTHER||Odds Ratio (OR)|35.0|||||TWO_SIDED|95.0|9.84|124.47|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||124.47|9.84|
91626903|NCT04153929|183145959|OTHER||Odds Ratio (OR)|8.22|||||TWO_SIDED|95.0|2.52|26.79|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||26.79|2.52|
91626904|NCT04153929|183145960|OTHER||Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|0.14|95.73|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||95.73|0.14|
91626905|NCT04153929|183145960|OTHER||Odds Ratio (OR)|7.97|||||TWO_SIDED|95.0|0.39|163.56|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||163.56|0.39|
91626906|NCT04153929|183145960|OTHER||Odds Ratio (OR)|25.17|||||TWO_SIDED|95.0|1.35|471.09|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||471.09|1.35|
91626907|NCT04153929|183145960|OTHER||Odds Ratio (OR)|33.01|||||TWO_SIDED|95.0|1.78|613.51||||||Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||613.51|1.78|
91626908|NCT04153929|183145960|OTHER||Odds Ratio (OR)|42.44|||||TWO_SIDED|95.0|2.37|761.44|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||761.44|2.37|
91626909|NCT04153929|183145960|OTHER||Odds Ratio (OR)|84.53|||||TWO_SIDED|95.0|4.71|999.0|||||Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||999|4.71|
91626910|NCT04153929|183145960|OTHER||Odds Ratio (OR)|22.44|||||TWO_SIDED|95.0|1.22|413.33|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||413.33|1.22|
91626911|NCT00108953|183146066|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.6||||0.016||95.0|0.33|0.95|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.||0.95|0.33|0.016
91626912|NCT00108953|183146067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.007||95.0|0.37|0.74|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.74|0.37|0.007
91626913|NCT00108953|183146068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.018||95.0|0.45|0.83|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.83|0.45|0.018
91626914|NCT00108953|183146070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.038||95.0|0.4|1.05|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||1.05|0.40|0.038
91482314|NCT02117414|182838427|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 8%.|Difference in percentages|0.6||||0.0001|ONE_SIDED|95.0|-4.1|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group - 8% HA: % successes MRI group \> % successes Control group - 8%"|||-4.1|0.0001
91482315|NCT02117414|182838428|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis will be rejected if the one-sided 95% log-log transformed lower confidence bound at 120 days post-implant calculated using Kaplan-Meier (K-M) method is greater than 80%.|Complication-free rate|95.9|||<|0.0001|ONE_SIDED|95.0|93.0|||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||"The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p \> 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit)."|||93.0|<0.0001
91482316|NCT02117414|182838429|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|1.2|||<|1e-05|ONE_SIDED|90.0|-3.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|||-3.1|<0.00001
91482317|NCT02117414|182838430|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%|Difference in percentages|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.05. Because the success rate was 100% in each group, a p-value could not be calculated.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."||||
91482318|NCT02117414|182838431|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|-1.3||||0.006|ONE_SIDED|90.0|-7.0||||Farrington-Manning non-inferiority test|||"The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-7.0|0.006
91482319|NCT02117414|182838432|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|0.3||||0.005|ONE_SIDED|90.0|-6.2|||A priori threshold for statistical significance was 0.05|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-6.2|0.005
91482320|NCT00701376|182838433|SUPERIORITY||Mean Difference (Net)|-6.32||||0.03|TWO_SIDED|99.8|-15.6|2.94|||paired t-test|||||2.94|-15.6|0.03
91525336|NCT01641926|182925977|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.9|||||TWO_SIDED|95.0|-7.4|9.2||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||9.2|-7.4|
91626915|NCT00293241|183146076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.72|TWO_SIDED|95.0|0.612|1.405|||Log Rank||"Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition~CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism"|"Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600"||1.405|0.612|0.72
91626916|NCT00293241|183146077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.127||||0.48|TWO_SIDED|95.0|0.808|1.57|||Log Rank|||"Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization"||1.570|0.808|0.48
91663713|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91482321|NCT00701376|182838434|SUPERIORITY||Mean Difference (Net)|-7.56||||0.08|TWO_SIDED|99.8|-22.0|6.83|||Wilcoxon (Mann-Whitney)|||||6.83|-22.0|0.08
91482322|NCT00701376|182838435|SUPERIORITY||Mean Difference (Net)|5.84||||0.14|TWO_SIDED|99.8|-7.55|19.2|||paired t-test|||||19.2|-7.55|0.14
91525337|NCT00152009|182925984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0006
91525338|NCT00152009|182925984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0005
91525339|NCT00152009|182925984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
91626917|NCT00293241|183146078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.521||||0.08|TWO_SIDED|95.0|0.954|2.424|||Log Rank|||Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF||2.424|0.954|0.08
91663714|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91525340|NCT00152009|182925985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.025
91626918|NCT00293241|183146079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.425||||0.44|TWO_SIDED|95.0|0.573|3.543|||Log Rank|||Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF||3.543|0.573|0.44
91626919|NCT00293241|183146080|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:"||||<0.0001
91626920|NCT00293241|183146081|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Regression, Linear|||||||0.048
91626921|NCT00293241|183146083|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|95.0|||||Repeated measures logistic regression|||Analysis:Repeated measures logistic regression||||0.78
91626922|NCT00293241|183146084|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers||||0.34
91626923|NCT00293241|183146084|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin||||0.65
91626924|NCT00293241|183146084|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists||||0.55
91626925|NCT00293241|183146084|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug||||0.53
91626926|NCT00293241|183146086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.33|TWO_SIDED|95.0|0.803|1.923|||Log Rank|||"Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF"||1.923|0.803|0.33
91626927|NCT00293241|183146087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.492||||0.24|TWO_SIDED|95.0|0.148|1.637|||Log Rank|||||1.637|0.148|0.24
91663715|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663716|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91626928|NCT00293241|183146088|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical test for Number of subjects with CV hospitalization||||0.83
91626929|NCT00293241|183146091|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval||||0.34
91626930|NCT00293241|183146091|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration||||0.19
91626931|NCT00293241|183146091|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration||||0.29
91626932|NCT00293241|183146092|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher Exact|||No Symptoms (Baseline)||||0.24
91626933|NCT00293241|183146092|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Fisher Exact|||No Symptoms (12 months)||||0.92
91626934|NCT00293241|183146092|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||No Symptoms (24 Months)||||1.0
91626935|NCT00293241|183146093|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91626936|NCT03803202|183146117|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.7|1.85|||t-test, 2 sided|||Serotype 1, Day 1||1.85|0.70|
91626937|NCT03803202|183146117|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.72|1.9|||t-test, 2 sided|||Serotype 1, Day 1||1.90|0.72|
91626938|NCT03803202|183146117|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.74|1.87|||t-test, 2 sided|||Serotype 1, Day 1||1.87|0.74|
91626939|NCT03803202|183146117|OTHER||Ratio of GMT|1.57|||||TWO_SIDED|95.0|0.68|3.63|||t-test, 2 sided|||Serotype 3, Day 1||3.63|0.68|
91626940|NCT03803202|183146117|OTHER||Ratio of GMT|2.04|||||TWO_SIDED|95.0|0.86|4.82|||t-test, 2 sided|||Serotype 3, Day 1||4.82|0.86|
91626941|NCT03803202|183146117|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.31|1.46|||t-test, 2 sided|||Serotype 3, Day 1||1.46|0.31|
91626942|NCT03803202|183146117|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.27|4.55|||t-test, 2 sided|||Serotype 4, Day 1||4.55|0.27|
91626943|NCT03803202|183146117|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.19|2.61|||t-test, 2 sided|||Serotype 4, Day 1||2.61|0.19|
91626944|NCT03803202|183146117|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||Serotype 4, Day 1||6.85|0.49|
91626945|NCT03803202|183146117|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|0.76|4.73|||t-test, 2 sided|||Serotype 5, Day 1||4.73|0.76|
91626946|NCT03803202|183146117|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.62|2.4|||t-test, 2 sided|||Serotype 5, Day 1||2.40|0.62|
91626947|NCT03803202|183146117|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.52|1.65|||t-test, 2 sided|||Serotype 5, Day 1||1.65|0.52|
91626948|NCT03803202|183146117|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.25|2.82|||t-test, 2 sided|||Serotype 6A, Day 1||2.82|0.25|
91626949|NCT03803202|183146117|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.24|2.23|||t-test, 2 sided|||Serotype 6A, Day 1||2.23|0.24|
91626950|NCT03803202|183146117|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Serotype 6A, Day 1||3.41|0.31|
91663717|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663718|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663719|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663720|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663721|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663722|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663723|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663724|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663725|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663726|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663727|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663728|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663729|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663730|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663731|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663732|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||0.008
91663733|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||0.007
91663734|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||0.002
91663735|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||0.002
91663736|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||0.006
91482323|NCT00701376|182838437|SUPERIORITY||Mean Difference (Net)|-0.2|||<|0.001|TWO_SIDED|99.8|-0.38|-0.02|||paired t-test|||||-0.02|-0.38|<0.001
91663737|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663738|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663739|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663740|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663741|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663742|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663743|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663744|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663745|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663746|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663747|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
91663748|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.005
91663749|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.002
91482324|NCT00701376|182838438|SUPERIORITY||Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|99.8|-0.68|0.23|||paired t-test|||||0.23|-0.68|0.10
91482325|NCT00701376|182838439|SUPERIORITY||Mean Difference (Net)|-1.72||||0.21|TWO_SIDED|99.8|-8.68|5.25|||paired t-test|||||5.25|-8.68|0.21
91482326|NCT00701376|182838441|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||||||0.002
91482327|NCT00701376|182838442|SUPERIORITY|||||||0.04|||||||Wilcoxon signed-rank test|||||||0.04
91482328|NCT00701376|182838443|SUPERIORITY|||||||0.005|||||||Wilcoxon signed-rank test|||||||0.005
91482329|NCT00701376|182838444|SUPERIORITY|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
91482330|NCT04025710|182838480|OTHER|single arm design|SADE-free rate|0.97||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||The primary hypothesis evaluates the SADE free rate (pSADE\_free) at 3 months. Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%||1|0.9|0.05
91482331|NCT00633867|182838512|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Log Rank|||||||<0.01
91482332|NCT05308290|182838513|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
91482333|NCT05308290|182838514|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
91482334|NCT05308290|182838515|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
91663750|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663751|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.004
91663752|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663753|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663754|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663755|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663756|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663757|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.39
91663758|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.17
91663759|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.34
91663760|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||0.016
91663761|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
91663762|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663763|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663764|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663765|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663766|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663767|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663768|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663769|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91482335|NCT05308290|182838516|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
91482336|NCT05308290|182838517|OTHER|||||||0.28||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.28
91482337|NCT00410202|182838527|SUPERIORITY_OR_OTHER||Difference Estimate|8.9||||0.1336|TWO_SIDED|95.0|-2.0|19.9|||Hochberg procedure|||||19.9|-2.0|0.1336
91482338|NCT00410202|182838527|SUPERIORITY_OR_OTHER||Difference Estimate|5.7||||0.2619|TWO_SIDED|95.0|-4.2|15.5|||Hochberg procedure|||||15.5|-4.2|0.2619
91482339|NCT00410202|182838528|SUPERIORITY_OR_OTHER||Difference estimate|15.0||||0.0095|TWO_SIDED|95.0|3.7|26.4|||Hochberg procedure|||||26.4|3.7|0.0095
91482340|NCT00410202|182838529|SUPERIORITY_OR_OTHER||Difference Estimate|11.8|||||TWO_SIDED|95.0|2.5|21.1||||||||21.1|2.5|
91663770|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663771|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663772|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.01
91663773|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
91663774|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663775|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663776|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663777|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663778|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663779|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663780|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663781|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663782|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.048
91663783|NCT00205777|183222245|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.038
91482341|NCT00410202|182838529|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-1.1|18.2||||||||18.2|-1.1|
91525341|NCT00152009|182925985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.035
91482342|NCT00410202|182838530|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|1.8|23.9||||||||23.9|1.8|
91482343|NCT00410202|182838531|SUPERIORITY_OR_OTHER||Difference Estimate|8.9|||||TWO_SIDED|95.0|0.3|17.4||||||||17.4|0.3|
91482344|NCT00410202|182838531|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-0.1|17.3||||||||17.3|-0.1|
91482345|NCT00410202|182838532|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|2.4|23.4||||||||23.4|2.4|
91482346|NCT00410202|182838535|SUPERIORITY_OR_OTHER||Difference Estimate|-1.26|||||TWO_SIDED|95.0|-1.534|-0.994|||Regression, Linear|||||-0.994|-1.534|
91482347|NCT00410202|182838535|SUPERIORITY_OR_OTHER||Difference Estimate|-0.55|||||TWO_SIDED|95.0|-0.824|-0.281|||Regression, Linear|||||-0.281|-0.824|
91482348|NCT00410202|182838537|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.5|10.7||||||||10.7|-15.5|
91482349|NCT00410202|182838537|SUPERIORITY_OR_OTHER||Difference Estimate|-1.2|||||TWO_SIDED|95.0|-15.0|12.6||||||||12.6|-15.0|
91626951|NCT03803202|183146117|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.32|4.46|||t-test, 2 sided|||Serotype 6B,Day 1||4.46|0.32|
91626952|NCT03803202|183146117|OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.42|4.05|||t-test, 2 sided|||Serotype 6B, Day 1||4.05|0.42|
91626953|NCT03803202|183146117|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.24|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.24|
91626954|NCT03803202|183146117|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.26|2.17|||t-test, 2 sided|||Serotype 7F, Day 1||2.17|0.26|
91626955|NCT03803202|183146117|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.11|0.89|||t-test, 2 sided|||Serotype 7F, Day 1||0.89|0.11|
91626956|NCT03803202|183146117|OTHER||Ratio of GMT|0.31|||||TWO_SIDED|95.0|0.1|0.93|||t-test, 2 sided|||Serotype 7F, Day 1||0.93|0.10|
91626957|NCT03803202|183146117|OTHER||Ratio of GMT|1.92|||||TWO_SIDED|95.0|0.74|4.99|||t-test, 2 sided|||Serotype 9V, Day 1||4.99|0.74|
91626958|NCT03803202|183146117|OTHER||Ratio of GMT|0.48|||||TWO_SIDED|95.0|0.15|1.61|||t-test, 2 sided|||Serotype 9V, Day 1||1.61|0.15|
91626959|NCT03803202|183146117|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.21|1.9|||t-test, 2 sided|||Serotype 9V, Day 1||1.90|0.21|
91626960|NCT03803202|183146117|OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|1.17|15.09|||t-test, 2 sided|||Serotype 14, Day 1||15.09|1.17|
91626961|NCT03803202|183146117|OTHER||Ratio of GMT|1.91|||||TWO_SIDED|95.0|0.52|7.07|||t-test, 2 sided|||Serotype 14, Day 1||7.07|0.52|
91626962|NCT03803202|183146117|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.23|4.25|||t-test, 2 sided|||Serotype 14, Day 1||4.25|0.23|
91626963|NCT03803202|183146117|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.21|2.62|||t-test, 2 sided|||Serotype 18C, Day 1||2.62|0.21|
91626964|NCT03803202|183146117|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.37|3.77|||t-test, 2 sided|||Serotype 18C, Day 1||3.77|0.37|
91626965|NCT03803202|183146117|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.38|3.94|||t-test, 2 sided|||Serotype 18C, Day 1||3.94|0.38|
91626966|NCT03803202|183146117|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.51|2.45|||t-test, 2 sided|||Serotype 19A, Day 1||2.45|0.51|
91626967|NCT03803202|183146117|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.31|1.63|||t-test, 2 sided|||Serotype 19A, Day 1||1.63|0.31|
91626968|NCT03803202|183146117|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.36|1.53|||t-test, 2 sided|||Serotype 19A, Day 1||1.53|0.36|
91626969|NCT03803202|183146117|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.24|2.08|||t-test, 2 sided|||Serotype 19F, Day 1||2.08|0.24|
91626970|NCT03803202|183146117|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.44|3.5|||t-test, 2 sided|||Serotype 19F, Day 1||3.50|0.44|
91626971|NCT03803202|183146117|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.58|3.61|||t-test, 2 sided|||Serotype 19F, Day 1||3.61|0.58|
91626972|NCT03803202|183146117|OTHER||Ratio of GMT|2.22|||||TWO_SIDED|95.0|0.46|10.69|||t-test, 2 sided|||Serotype 23F, Day 1||10.69|0.46|
91626973|NCT03803202|183146117|OTHER||Ratio of GMT|1.36|||||TWO_SIDED|95.0|0.31|5.99|||t-test, 2 sided|||Serotype 23F, Day 1||5.99|0.31|
91626974|NCT03803202|183146117|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.15|3.01|||t-test, 2 sided|||Serotype 23F, Day 1||3.01|0.15|
91626975|NCT03803202|183146117|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.5|1.74|||t-test, 2 sided|||Serotype 1, Day 30||1.74|0.50|
91626976|NCT03803202|183146117|OTHER||Ratio of GMT|0.72|||||TWO_SIDED|95.0|0.39|1.32|||t-test, 2 sided|||Serotype 1, Day 30||1.32|0.39|
91626977|NCT03803202|183146117|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.35|1.39|||t-test, 2 sided|||Serotype 1, Day 30||1.39|0.35|
91626978|NCT03803202|183146117|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.66|1.8|||t-test, 2 sided|||Serotype 3, Day 30||1.80|0.66|
91626979|NCT03803202|183146117|OTHER||Ratio of GMT|1.44|||||TWO_SIDED|95.0|0.9|2.29|||t-test, 2 sided|||Serotype 3, Day 30||2.29|0.90|
91626980|NCT03803202|183146117|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.76|2.17|||t-test, 2 sided|||Serotype 3, Day 30||2.17|0.76|
91626981|NCT03803202|183146117|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.5|1.35|||t-test, 2 sided|||Serotype 4, Day 30||1.35|0.50|
91626982|NCT03803202|183146117|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.24|1.02|||t-test, 2 sided|||Serotype 4, Day 30||1.02|0.24|
91626983|NCT03803202|183146117|OTHER||Ratio of GMT|1.06|||||TWO_SIDED|95.0|0.6|1.89|||t-test, 2 sided|||Serotype 4, Day 30||1.89|0.60|
91626984|NCT03803202|183146117|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.41|1.15|||t-test, 2 sided|||Serotype 5, Day 30||1.15|0.41|
91626985|NCT03803202|183146117|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.2|||t-test, 2 sided|||Serotype 5, Day 30||1.20|0.31|
91626986|NCT03803202|183146117|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.48|1.32|||t-test, 2 sided|||Serotype 5, Day 30||1.32|0.48|
91626987|NCT03803202|183146117|OTHER||Ratio of GMT|0.52|||||TWO_SIDED|95.0|0.28|0.98|||t-test, 2 sided|||Serotype 6A, Day 30||0.98|0.28|
91626988|NCT03803202|183146117|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.15|0.68|||t-test, 2 sided|||Serotype 6A, Day 30||0.68|0.15|
91626989|NCT03803202|183146117|OTHER||Ratio of GMT|0.37|||||TWO_SIDED|95.0|0.21|0.66|||t-test, 2 sided|||Serotype 6A, Day 30||0.66|0.21|
91626990|NCT03803202|183146117|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.42|1.18|||t-test, 2 sided|||Serotype 6B, Day 30||1.18|0.42|
91626991|NCT03803202|183146117|OTHER||Ratio of GMT|0.45|||||TWO_SIDED|95.0|0.25|0.83|||t-test, 2 sided|||Serotype 6B, Day 30||0.83|0.25|
91663784|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663785|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663786|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663787|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663788|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663789|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663790|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663791|NCT00205777|183222245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663792|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663793|NCT00205777|183222246|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.010
91663794|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
91663795|NCT00205777|183222246|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.023
91663796|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663797|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663798|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663799|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663800|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663801|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663802|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663803|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663804|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663805|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663806|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663807|NCT00205777|183222246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
91663808|NCT00205777|183222247|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANCOVA|||Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.34
91663809|NCT00205777|183222247|SUPERIORITY_OR_OTHER|||||||0.15|||||||ANCOVA|||Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.15
91663810|NCT00205777|183222247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91482350|NCT00410202|182838538|SUPERIORITY_OR_OTHER||Difference Estimate|-2.8|||||TWO_SIDED|95.0|-16.2|10.6||||||||10.6|-16.2|
91663811|NCT00205777|183222247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
91663812|NCT00205777|183222247|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663813|NCT00205777|183222247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
91663814|NCT00205777|183222247|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.003
91663815|NCT00205777|183222247|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
91663816|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663817|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663818|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663819|NCT00205777|183222248|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.93
91663820|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663821|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663822|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663823|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663824|NCT00205777|183222248|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.30
91663825|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663826|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663827|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663828|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91714064|NCT02782741|183319782|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|5.64||0.7321|TWO_SIDED|95.0|-13.17|9.29|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MEP % predicted adjusted for MEP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||9.29|-13.17|0.7321
91482351|NCT00410202|182838539|SUPERIORITY_OR_OTHER||Difference Estimate|0.8|||||TWO_SIDED|95.0|-5.2|6.7||||||||6.7|-5.2|
91663829|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663830|NCT00205777|183222248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663831|NCT00205777|183222249|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663832|NCT00205777|183222249|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663833|NCT00205777|183222249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663834|NCT00205777|183222249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
91663835|NCT00205777|183222250|SUPERIORITY_OR_OTHER|||||||0.037|||||||Ranked ANCOVA|||Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.037
91663836|NCT00205777|183222250|SUPERIORITY_OR_OTHER|||||||0.16|||||||Ranked ANCOVA|||Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.16
91663837|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663838|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91482352|NCT00410202|182838539|SUPERIORITY_OR_OTHER||Difference Estimate|1.3|||||TWO_SIDED|95.0|-4.6|7.2||||||||7.2|-4.6|
91482353|NCT00410202|182838540|SUPERIORITY_OR_OTHER||Difference Estimate|-1.5|||||TWO_SIDED|95.0|-9.5|6.4||||||||6.4|-9.5|
91482354|NCT00410202|182838541|SUPERIORITY_OR_OTHER||Difference Estimate|2.2|||||TWO_SIDED|95.0|-2.4|6.8||||||||6.8|-2.4|
91482355|NCT00410202|182838541|SUPERIORITY_OR_OTHER||Difference Estimate|1.4|||||TWO_SIDED|95.0|-3.5|6.2||||||||6.2|-3.5|
91482356|NCT00410202|182838542|SUPERIORITY_OR_OTHER||Difference Estimate|2.1|||||TWO_SIDED|95.0|-3.6|7.8||||||||7.8|-3.6|
91482357|NCT00410202|182838543|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
91482358|NCT00410202|182838543|SUPERIORITY_OR_OTHER||Difference Estimate|0.0|||||TWO_SIDED|95.0|-2.0|2.0||||||||2.0|-2.0|
91663839|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663840|NCT00205777|183222251|SUPERIORITY_OR_OTHER|||||||0.4|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.40
91663841|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663842|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663843|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663844|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663845|NCT00205777|183222251|SUPERIORITY_OR_OTHER|||||||0.004|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.004
91663846|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663847|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663848|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663849|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663850|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663851|NCT00205777|183222251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663852|NCT00205777|183222252|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663853|NCT00205777|183222252|SUPERIORITY_OR_OTHER|||||||0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.001
91663854|NCT00205777|183222252|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
91663855|NCT00205777|183222252|SUPERIORITY_OR_OTHER|||||||0.009|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.009
91663856|NCT00205777|183222253|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Ranked ANCOVA|||Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.034
91663857|NCT00205777|183222253|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Ranked ANCOVA|||Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.77
91663858|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663859|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663860|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663861|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663862|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663863|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663864|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663865|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.001
91663866|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91792064|NCT02360605|183461849|SUPERIORITY|||||||0.61||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.||||0.61
91663867|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663868|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663869|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663870|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||0.009
91663871|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663872|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||0.055
91663873|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.004
91663874|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663875|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663876|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663877|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
91663878|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
91663879|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
91663880|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
91663881|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
91663882|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
91663883|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
91663884|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
91663885|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
91482359|NCT00410202|182838545|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
91626992|NCT03803202|183146117|OTHER||Ratio of GMT|0.43|||||TWO_SIDED|95.0|0.24|0.76|||t-test, 2 sided|||Serotype 6B, Day 30||0.76|0.24|
91626993|NCT03803202|183146117|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.51|1.29|||t-test, 2 sided|||Serotype 7F, Day 30||1.29|0.51|
91626994|NCT03803202|183146117|OTHER||Ratio of GMT|0.68|||||TWO_SIDED|95.0|0.47|0.99|||t-test, 2 sided|||Serotype 7F, Day 30||0.99|0.47|
91626995|NCT03803202|183146117|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.53|1.25|||t-test, 2 sided|||Serotype 7F, Day 30||1.25|0.53|
91663886|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
91626996|NCT03803202|183146117|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.35|1.08|||t-test, 2 sided|||Serotype 9V, Day 30||1.08|0.35|
91663887|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
91663888|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
91663889|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
91663890|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||0.012
91792065|NCT02360605|183461850|SUPERIORITY|||||||0.3||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.30
91482360|NCT00410202|182838545|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
91482361|NCT01352468|182838552|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|Controlling for baseline scores||||||.35
91626997|NCT03803202|183146117|OTHER||Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.31|1.03|||t-test, 2 sided|||Serotype 9V, Day 30||1.03|0.31|
91626998|NCT03803202|183146117|OTHER||Ratio of GMT|0.77|||||TWO_SIDED|95.0|0.46|1.28|||t-test, 2 sided|||Serotype 9V, Day 30||1.28|0.46|
91626999|NCT03803202|183146117|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.27|1.08|||t-test, 2 sided|||Serotype 14, Day 30||1.08|0.27|
91627000|NCT03803202|183146117|OTHER||Ratio of GMT|0.28|||||TWO_SIDED|95.0|0.1|0.77|||t-test, 2 sided|||Serotype 14, Day 30||0.77|0.10|
91627001|NCT03803202|183146117|OTHER||Ratio of GMT|1.13|||||TWO_SIDED|95.0|0.56|2.3|||t-test, 2 sided|||Serotype 14, Day 30||2.30|0.56|
91627002|NCT03803202|183146117|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.53|1.5|||t-test, 2 sided|||Serotype 18C, Day 30||1.50|0.53|
91627003|NCT03803202|183146117|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.23|||t-test, 2 sided|||Serotype 18C, Day 30||1.23|0.39|
91627004|NCT03803202|183146117|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.28|||t-test, 2 sided|||Serotype 18C, Day 30||1.28|0.50|
91663891|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
91663892|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||0.031
91663893|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||0.008
91663894|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
91663895|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
91663896|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
91663897|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
91663898|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
91663899|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
91663900|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.001
91663901|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
91482362|NCT01352468|182838553|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|Controlling for baseline scores||||||.68
91482363|NCT01352468|182838554|SUPERIORITY_OR_OTHER|||||||0.57|||||||ANCOVA|Controlling for baseline scores||||||.57
91482364|NCT01178073|182838555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0002|TWO_SIDED|95.0|0.348|0.724|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.724|0.348|0.0002
91627005|NCT03803202|183146117|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.32|0.79|||t-test, 2 sided|||Serotype 19A, Day 30||0.79|0.32|
91627006|NCT03803202|183146117|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.45|1.09|||t-test, 2 sided|||Serotype 19A, Day 30||1.09|0.45|
91627007|NCT03803202|183146117|OTHER||Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.42|0.96|||t-test, 2 sided|||Serotype 19A, Day 30||0.96|0.42|
91627008|NCT03803202|183146117|OTHER||Ratio of GMT|0.56|||||TWO_SIDED|95.0|0.34|0.92|||t-test, 2 sided|||Serotype 19F, Day 30||0.92|0.34|
91663902|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.10
91663903|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.89
91663904|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.60
91663905|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.82
91663906|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
91525342|NCT00152009|182925985|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
91627009|NCT03803202|183146117|OTHER||Ratio of GMT|0.64|||||TWO_SIDED|95.0|0.37|1.1|||t-test, 2 sided|||Serotype 19F, Day 30||1.10|0.37|
91627010|NCT03803202|183146117|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.56|1.55|||t-test, 2 sided|||Serotype 19F, Day 30||1.55|0.56|
91627011|NCT03803202|183146117|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.46|||t-test, 2 sided|||Serotype 23F, Day 30||0.46|0.08|
91627012|NCT03803202|183146117|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.47|||t-test, 2 sided|||Serotype 23F, Day 30||0.47|0.08|
91627013|NCT03803202|183146117|OTHER||Ratio of GMT|0.23|||||TWO_SIDED|95.0|0.09|0.57|||t-test, 2 sided|||Serotype 23F, Day 30||0.57|0.09|
91627014|NCT03803202|183146118|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.52|2.23|||t-test, 2 sided|||Serotype 1, Day 1||2.23|0.52|
91627015|NCT03803202|183146118|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.51|1.98|||t-test, 2 sided|||Serotype 1, Day 1||1.98|0.51|
91627016|NCT03803202|183146118|OTHER||Ratio of GMC|1.43|||||TWO_SIDED|95.0|0.72|2.83|||t-test, 2 sided|||Serotype 1, Day 1||2.83|0.72|
91627017|NCT03803202|183146118|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.59|2.68|||t-test, 2 sided|||Serotype 3, Day 1||2.68|0.59|
91627018|NCT03803202|183146118|OTHER||Ratio of GMC|1.65|||||TWO_SIDED|95.0|0.9|3.05|||t-test, 2 sided|||Serotype 3, Day 1||3.05|0.90|
91627019|NCT03803202|183146118|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.68|2.25|||t-test, 2 sided|||Serotype 3, Day 1||2.25|0.68|
91627020|NCT03803202|183146118|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.49|2.15|||t-test, 2 sided|||Serotype 4, Day 1||2.15|0.49|
91627021|NCT03803202|183146118|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.39|1.74|||t-test, 2 sided|||Serotype 4, Day 1||1.74|0.39|
91627022|NCT03803202|183146118|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.59|2.59|||t-test, 2 sided|||Serotype 4, Day 1||2.59|0.59|
91663907|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
91663908|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.012
91663909|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
91663910|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.083
91627023|NCT03803202|183146118|OTHER||Ratio of GMC|1.71|||||TWO_SIDED|95.0|0.75|3.91|||t-test, 2 sided|||Serotype 5, Day 1||3.91|0.75|
91627024|NCT03803202|183146118|OTHER||Ratio of GMC|0.72|||||TWO_SIDED|95.0|0.36|1.46|||t-test, 2 sided|||Serotype 5, Day 1||1.46|0.36|
91627025|NCT03803202|183146118|OTHER||Ratio of GMC|0.93|||||TWO_SIDED|95.0|0.47|1.84|||t-test, 2 sided|||Serotype 5, Day 1||1.84|0.47|
91627026|NCT03803202|183146118|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.57|2.52|||t-test, 2 sided|||Serotype 6A, Day 1||2.52|0.57|
91627027|NCT03803202|183146118|OTHER||Ratio of GMC|1.28|||||TWO_SIDED|95.0|0.64|2.56|||t-test, 2 sided|||Serotype 6A, Day 1||2.56|0.64|
91627028|NCT03803202|183146118|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.52|2.28|||t-test, 2 sided|||Serotype 6A, Day 1||2.28|0.52|
91627029|NCT03803202|183146118|OTHER||Ratio of GMC|1.23|||||TWO_SIDED|95.0|0.49|3.09|||t-test, 2 sided|||Serotype 6B, Day 1||3.09|0.49|
91627030|NCT03803202|183146118|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.43|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.43|
91627031|NCT03803202|183146118|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.37|1.73|||t-test, 2 sided|||Serotype 6B, Day 1||1.73|0.37|
91627032|NCT03803202|183146118|OTHER||Ratio of GMC|1.51|||||TWO_SIDED|95.0|0.76|3.01|||t-test, 2 sided|||Serotype 7F, Day 1||3.01|0.76|
91627033|NCT03803202|183146118|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.69|1.94|||t-test, 2 sided|||Serotype 7F, Day 1||1.94|0.69|
91627034|NCT03803202|183146118|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|0.98|2.91|||t-test, 2 sided|||Serotype 7F, Day 1||2.91|0.98|
91627035|NCT03803202|183146118|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.54|2.22|||t-test, 2 sided|||Serotype 9V, Day 1||2.22|0.54|
91627036|NCT03803202|183146118|OTHER||Ratio of GMC|0.74|||||TWO_SIDED|95.0|0.41|1.36|||t-test, 2 sided|||Serotype 9V, Day 1||1.36|0.41|
91627037|NCT03803202|183146118|OTHER||Ratio of GMC|0.85|||||TWO_SIDED|95.0|0.47|1.55|||t-test, 2 sided|||Serotype 9V, Day 1||1.55|0.47|
91627038|NCT03803202|183146118|OTHER||Ratio of GMC|2.05|||||TWO_SIDED|95.0|0.84|4.99|||t-test, 2 sided|||Serotype 14, Day 1||4.99|0.84|
91627039|NCT03803202|183146118|OTHER||Ratio of GMC|2.6|||||TWO_SIDED|95.0|1.13|5.98|||t-test, 2 sided|||Serotype 14, Day 1||5.98|1.13|
91627040|NCT03803202|183146118|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.37|2.15|||t-test, 2 sided|||Serotype 14, Day 1||2.15|0.37|
91627041|NCT03803202|183146118|OTHER||Ratio of GMC|1.37|||||TWO_SIDED|95.0|0.61|3.06|||t-test, 2 sided|||Serotype 18C, Day 1||3.06|0.61|
91627042|NCT03803202|183146118|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.55|2.09|||t-test, 2 sided|||Serotype 18C, Day 1||2.09|0.55|
91627043|NCT03803202|183146118|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.59|2.65|||t-test, 2 sided|||Serotype 18C, Day 1||2.65|0.59|
91627044|NCT03803202|183146118|OTHER||Ratio of GMC|1.61|||||TWO_SIDED|95.0|0.74|3.49|||t-test, 2 sided|||Serotype 19A, Day 1||3.49|0.74|
91627045|NCT03803202|183146118|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.42|1.65|||t-test, 2 sided|||Serotype 19A, Day 1||1.65|0.42|
91627046|NCT03803202|183146118|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.05|||t-test, 2 sided|||Serotype 19A, Day 1||2.05|0.49|
91663911|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.96
91663912|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.84
91663913|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.15
91663914|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.13
91663915|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
91663916|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.007
91663917|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
91663918|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.28
91663919|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA||||0.10
91482365|NCT01178073|182838555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.477||||0.0004|TWO_SIDED|95.0|0.314|0.723|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||0.723|0.314|0.0004
91482366|NCT01178073|182838555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0045|TWO_SIDED|95.0|0.338|0.827|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||0.827|0.338|0.0045
91482367|NCT01178073|182838556|SUPERIORITY_OR_OTHER||Mean Percent Difference|-33.81|||<|0.0001|TWO_SIDED|95.0|-44.78|-20.66|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||-20.66|-44.78|<0.0001
91627047|NCT03803202|183146118|OTHER||Ratio of GMC|1.47|||||TWO_SIDED|95.0|0.63|3.39|||t-test, 2 sided|||Serotype 19F, Day 1||3.39|0.63|
91627048|NCT03803202|183146118|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.64|3.07|||t-test, 2 sided|||Serotype 19F, Day 1||3.07|0.64|
91627049|NCT03803202|183146118|OTHER||Ratio of GMC|1.12|||||TWO_SIDED|95.0|0.53|2.34|||t-test, 2 sided|||Serotype 19F, Day 1||2.34|0.53|
91627050|NCT03803202|183146118|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.49|2.09|||t-test, 2 sided|||Serotype 23F, Day 1||2.09|0.49|
91627051|NCT03803202|183146118|OTHER||Ratio of GMC|0.94|||||TWO_SIDED|95.0|0.5|1.75|||t-test, 2 sided|||Serotype 23F, Day 1||1.75|0.50|
91627052|NCT03803202|183146118|OTHER||Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.42|2.0|||t-test, 2 sided|||Serotype 23F, Day 1||2.00|0.42|
91663920|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.94
91663921|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.46
91663922|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.63
91663923|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.70
91663924|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.58
91627053|NCT03803202|183146118|OTHER||Ratio of GMC|0.7|||||TWO_SIDED|95.0|0.38|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.38|
91627054|NCT03803202|183146118|OTHER||Ratio of GMC|0.95|||||TWO_SIDED|95.0|0.52|1.73|||t-test, 2 sided|||Serotype 1, Day 30||1.73|0.52|
91627055|NCT03803202|183146118|OTHER||Ratio of GMC|1.5|||||TWO_SIDED|95.0|0.84|2.66|||t-test, 2 sided|||Serotype 1, Day 30||2.66|0.84|
91627056|NCT03803202|183146118|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.84|2.28|||t-test, 2 sided|||Serotype 3, Day 30||2.28|0.84|
91627057|NCT03803202|183146118|OTHER||Ratio of GMC|2.68|||||TWO_SIDED|95.0|1.71|4.19|||t-test, 2 sided|||Serotype 3, Day 30||4.19|1.71|
91627058|NCT03803202|183146118|OTHER||Ratio of GMC|3.87|||||TWO_SIDED|95.0|2.47|6.06|||t-test, 2 sided|||Serotype 3, Day 30||6.06|2.47|
91627059|NCT03803202|183146118|OTHER||Ratio of GMC|1.27|||||TWO_SIDED|95.0|0.7|2.3|||t-test, 2 sided|||Serotype 4, Day 30||2.30|0.70|
91627060|NCT03803202|183146118|OTHER||Ratio of GMC|1.02|||||TWO_SIDED|95.0|0.57|1.81|||t-test, 2 sided|||Serotype 4, Day 30||1.81|0.57|
91627061|NCT03803202|183146118|OTHER||Ratio of GMC|2.24|||||TWO_SIDED|95.0|1.21|4.15|||t-test, 2 sided|||Serotype 4, Day 30||4.15|1.21|
91627062|NCT03803202|183146118|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.7|3.57|||t-test, 2 sided|||Serotype 5, Day 30||3.57|0.70|
91627063|NCT03803202|183146118|OTHER||Ratio of GMC|0.84|||||TWO_SIDED|95.0|0.35|2.05|||t-test, 2 sided|||Serotype 5, Day 30||2.05|0.35|
91627064|NCT03803202|183146118|OTHER||Ratio of GMC|1.49|||||TWO_SIDED|95.0|0.65|3.39|||t-test, 2 sided|||Serotype 5, Day 30||3.39|0.65|
91627065|NCT03803202|183146118|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.41|1.93|||t-test, 2 sided|||Serotype 6A, Day 30||1.93|0.41|
91627066|NCT03803202|183146118|OTHER||Ratio of GMC|0.77|||||TWO_SIDED|95.0|0.33|1.79|||t-test, 2 sided|||Serotype 6A, Day 30||1.79|0.33|
91627067|NCT03803202|183146118|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.32|1.48|||t-test, 2 sided|||Serotype 6A, Day 30||1.48|0.32|
91627068|NCT03803202|183146118|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.57|2.83|||t-test, 2 sided|||Serotype 6B, Day 30||2.83|0.57|
91663925|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.29
91663926|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.59
91663927|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.036
91663928|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.57
91663929|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.49
91663930|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.038
91663931|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.93
91663932|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.96
91627069|NCT03803202|183146118|OTHER||Ratio of GMC|0.75|||||TWO_SIDED|95.0|0.31|1.81|||t-test, 2 sided|||Serotype 6B, Day 30||1.81|0.31|
91627070|NCT03803202|183146118|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.39|1.97|||t-test, 2 sided|||Serotype 6B, Day 30||1.97|0.39|
91627071|NCT03803202|183146118|OTHER||Ratio of GMC|1.86|||||TWO_SIDED|95.0|1.05|3.3|||t-test, 2 sided|||Serotype 7F, Day 30||3.30|1.05|
91627072|NCT03803202|183146118|OTHER||Ratio of GMC|1.98|||||TWO_SIDED|95.0|1.1|3.55|||t-test, 2 sided|||Serotype 7F, Day 30||3.55|1.10|
91627073|NCT03803202|183146118|OTHER||Ratio of GMC|2.88|||||TWO_SIDED|95.0|1.62|5.12|||t-test, 2 sided|||Serotype 7F, Day 30||5.12|1.62|
91663933|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.72
91663934|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.12
91663935|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.043
91627074|NCT03803202|183146118|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.49|1.87|||t-test, 2 sided|||Serotype 9V, Day 30||1.87|0.49|
91627075|NCT03803202|183146118|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.74|2.62|||t-test, 2 sided|||Serotype 9V, Day 30||2.62|0.74|
91663936|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.53
91663937|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.75
91663938|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663939|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663940|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663941|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663942|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.46
91663943|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.64
91663944|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.47
91663945|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.75
91627076|NCT03803202|183146118|OTHER||Ratio of GMC|1.68|||||TWO_SIDED|95.0|0.87|3.27|||t-test, 2 sided|||Serotype 9V, Day 30||3.27|0.87|
91627077|NCT03803202|183146118|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.41|2.53|||t-test, 2 sided|||Serotype 14, Day 30||2.53|0.41|
91627078|NCT03803202|183146118|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.45|2.6|||t-test, 2 sided|||Serotype 14, Day 30||2.60|0.45|
91627079|NCT03803202|183146118|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|0.86|5.04|||t-test, 2 sided|||Serotype 14, Day 30||5.04|0.86|
91627080|NCT03803202|183146118|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.57|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.57|
91627081|NCT03803202|183146118|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.53|1.89|||t-test, 2 sided|||Serotype 18C, Day 30||1.89|0.53|
91627082|NCT03803202|183146118|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.56|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.56|
91627083|NCT03803202|183146118|OTHER||Ratio of GMC|0.68|||||TWO_SIDED|95.0|0.4|1.14|||t-test, 2 sided|||Serotype 19A, Day 30||1.14|0.40|
91627084|NCT03803202|183146118|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.46|1.61|||t-test, 2 sided|||Serotype 19A, Day 30||1.61|0.46|
91627085|NCT03803202|183146118|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.47|1.6|||t-test, 2 sided|||Serotype 19A, Day 30||1.60|0.47|
91627086|NCT03803202|183146118|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.01|||t-test, 2 sided|||Serotype 19F, Day 30||2.01|0.49|
91627087|NCT03803202|183146118|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.75|2.53|||t-test, 2 sided|||Serotype 19F, Day 30||2.53|0.75|
91627088|NCT03803202|183146118|OTHER||Ratio of GMC|1.41|||||TWO_SIDED|95.0|0.68|2.96|||t-test, 2 sided|||Serotype 19F, Day 30||2.96|0.68|
91627089|NCT03803202|183146118|OTHER||Ratio of GMC|0.46|||||TWO_SIDED|95.0|0.2|1.07|||t-test, 2 sided|||Serotype 23F, Day 30||1.07|0.20|
91627090|NCT03803202|183146118|OTHER||Ratio of GMC|0.5|||||TWO_SIDED|95.0|0.22|1.11|||t-test, 2 sided|||Serotype 23F, Day 30||1.11|0.22|
91627091|NCT03803202|183146118|OTHER||Ratio of GMC|0.64|||||TWO_SIDED|95.0|0.29|1.44|||t-test, 2 sided|||Serotype 23F, Day 30||1.44|0.29|
91663946|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.003
91663947|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663948|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663949|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663950|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.81
91663951|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.98
91663952|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.87
91663953|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.40
91663954|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.001
91663955|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663956|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663957|NCT00205777|183222254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
91663958|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.85
91663959|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.26
91663960|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
91663961|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.22
91663962|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.86
91482368|NCT01178073|182838556|SUPERIORITY_OR_OTHER||Mean Percent Difference|-25.09||||0.0111|TWO_SIDED|95.0|-40.04|-6.4|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||-6.40|-40.04|0.0111
91663963|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.65
91663964|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||1.00
91663965|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.44
91482369|NCT01178073|182838556|SUPERIORITY_OR_OTHER||Mean Percent Difference|-41.51|||<|0.0001|TWO_SIDED|95.0|-53.16|-26.97|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||-26.97|-53.16|<0.0001
91482370|NCT01178073|182838557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0264|TWO_SIDED|95.0|1.054|2.319|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||2.319|1.054|0.0264
91663966|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
91663967|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.55
91663968|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.34
91663969|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.96
91663970|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
91663971|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.031
91482371|NCT01178073|182838557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.424||||0.1518|TWO_SIDED|95.0|0.878|2.308|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||2.308|0.878|0.1518
91482372|NCT01178073|182838557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.723||||0.0321|TWO_SIDED|95.0|1.047|2.833|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||2.833|1.047|0.0321
91663972|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.054
91663973|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.62
91663974|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.99
91663975|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.11
91663976|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
91663977|NCT00205777|183222254|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.65
91663978|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.97|||||||ANOVA|||BV: P value was calculated using Analysis of Variance (ANOVA).||||0.97
91663979|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.19
91663980|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.74
91663981|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.79
91663982|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.11
91663983|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.78
91663984|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.90
91663985|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.33
91663986|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.51
91663987|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.28
91482373|NCT01178073|182838558|SUPERIORITY_OR_OTHER||Median Difference|22.75|||<|0.0001|TWO_SIDED|95.0|12.0|33.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||33.50|12.00|<0.0001
91482374|NCT01178073|182838558|SUPERIORITY_OR_OTHER||Median Difference|24.75||||0.0005|TWO_SIDED|95.0|11.0|38.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||38.50|11.00|0.0005
91482375|NCT01178073|182838558|SUPERIORITY_OR_OTHER||Median Difference|20.85||||0.003|TWO_SIDED|95.0|8.0|33.7|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||33.70|8.00|0.0030
91482376|NCT01178073|182838559|SUPERIORITY_OR_OTHER||Median Difference|0.0||||0.2287|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.0|0.0|0.2287
91482377|NCT01178073|182838559|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.0|0.0|
91482378|NCT01178073|182838559|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.0|0.0|
91482379|NCT01178073|182838560|SUPERIORITY_OR_OTHER||Median Difference|-0.38|||||TWO_SIDED|95.0|-0.75|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.00|-0.75|
91482380|NCT01178073|182838560|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.00|-1.00|
91525343|NCT00152009|182925986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
91627092|NCT03803202|183146122|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.56|1.14|||t-test, 2 sided|||Serotype 1, Day 1||1.14|0.56|
91627093|NCT03803202|183146122|OTHER||Ratio of GMT|1.39|||||TWO_SIDED|95.0|0.89|2.16|||t-test, 2 sided|||Serotype 1, Day 1||2.16|0.89|
91482381|NCT01178073|182838560|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.00|-1.00|
91482382|NCT04533685|182838600|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received reminder letters to the arm receiving no reminder letter (control)|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
91482383|NCT04533685|182838600|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare arms which received direct appointment scheduling to the arms not receiving direct appointment scheduling.|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
91482384|NCT04533685|182838600|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.01|||||These results compare arms which received pre-commitment reminders to the arms not receiving pre-commitment reminders.|Comparing the risk of receiving an influenza vaccination||1.01|1.00|
91482385|NCT04533685|182838600|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare arms which received pre-appointment reminder to the arms not receiving pre-appointment reminder.|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
91482386|NCT01226043|182838601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|2.15|2.44|||ANOVA|The last observation carried forward (LOCF) method was applied to impute missing Week 4 overall patient preference values for ANOVA analysis.||The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.||2.44|2.15|<0.0001
91482387|NCT00510952|182838629|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was 0.4%.|Mean Difference (Net)|-0.05||||0.551||95.0|-0.21|0.11||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin glargine, injected once a day, with regard to glycemic control as measured by change in HbA1c from baseline to 24 week endpoint (last observation carried forward).||0.11|-0.21|0.551
91627094|NCT03803202|183146122|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.51|1.06|||t-test, 2 sided|||Serotype 1, Day 1||1.06|0.51|
91627095|NCT03803202|183146122|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.85|2.09|||t-test, 2 sided|||Serotype 3, Day 1||2.09|0.85|
91627096|NCT03803202|183146122|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.91|2.3|||t-test, 2 sided|||Serotype 3, Day 1||2.30|0.91|
91627097|NCT03803202|183146122|OTHER||Ratio of GMT|0.95|||||TWO_SIDED|95.0|0.6|1.49|||t-test, 2 sided|||Serotype 3, Day 1||1.49|0.60|
91627098|NCT03803202|183146122|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.46|1.4|||t-test, 2 sided|||Serotype 4, Day 1||1.40|0.46|
91627099|NCT03803202|183146122|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.62|1.91|||t-test, 2 sided|||Serotype 4, Day 1||1.91|0.62|
91627100|NCT03803202|183146122|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.4|1.23|||t-test, 2 sided|||Serotype 4, Day 1||1.23|0.40|
91627101|NCT03803202|183146122|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 5, Day 1||1.68|0.58|
91627102|NCT03803202|183146122|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.76|2.29|||t-test, 2 sided|||Serotype 5, Day 1||2.29|0.76|
91627103|NCT03803202|183146122|OTHER||Ratio of GMT|0.88|||||TWO_SIDED|95.0|0.51|1.53|||t-test, 2 sided|||Serotype 5, Day 1||1.53|0.51|
91663988|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.86
91663989|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.60
91663990|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.84
91627104|NCT03803202|183146122|OTHER||Ratio of GMT|0.96|||||TWO_SIDED|95.0|0.54|1.72|||t-test, 2 sided|||Serotype 6A, Day 1||1.72|0.54|
91663991|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.98
91663992|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.47
91482388|NCT00510952|182838630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
91482389|NCT00510952|182838630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
91482390|NCT00510952|182838630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
91482391|NCT00510952|182838630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
91482392|NCT00510952|182838631|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.634
91482393|NCT00510952|182838631|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.504
91627105|NCT03803202|183146122|OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.57|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.57|
91627106|NCT03803202|183146122|OTHER||Ratio of GMT|1.63|||||TWO_SIDED|95.0|0.86|3.1|||t-test, 2 sided|||Serotype 6A, Day 1||3.10|0.86|
91627107|NCT03803202|183146122|OTHER||Ratio of GMT|1.61|||||TWO_SIDED|95.0|0.83|3.14|||t-test, 2 sided|||Serotype 6A, Day 1||3.14|0.83|
91627108|NCT03803202|183146122|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.59|2.24|||t-test, 2 sided|||Serotype 6B, Day 1||2.24|0.59|
91627109|NCT03803202|183146122|OTHER||Ratio of GMT|1.18|||||TWO_SIDED|95.0|0.58|2.39|||t-test, 2 sided|||Serotype 6B, Day 1||2.39|0.58|
91627110|NCT03803202|183146122|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.4|1.8|||t-test, 2 sided|||Serotype 7F, Day 1||1.80|0.40|
91627111|NCT03803202|183146122|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.63|2.87|||t-test, 2 sided|||Serotype 7F, Day 1||2.87|0.63|
91627112|NCT03803202|183146122|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.45|2.37|||t-test, 2 sided|||Serotype 7F, Day 1||2.37|0.45|
91627113|NCT03803202|183146122|OTHER||Ratio of GMT|0.65||||||95.0|0.32|1.32|||t-test, 2 sided|||Serotype 9V, Day 1||1.32|0.32|
91627114|NCT03803202|183146122|OTHER||Ratio of GMT|0.78|||||TWO_SIDED|95.0|0.37|1.64|||t-test, 2 sided|||Serotype 9V, Day 1||1.64|0.37|
91627115|NCT03803202|183146122|OTHER||Ratio of GMT|0.66|||||TWO_SIDED|95.0|0.3|1.49|||t-test, 2 sided|||Serotype 9V, Day 1||1.49|0.30|
91627116|NCT03803202|183146122|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.18|||t-test, 1 sided|||Serotype 14, Day 1||1.18|0.31|
91627117|NCT03803202|183146122|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.54|2.18|||t-test, 2 sided|||Serotype 14, Day 1||2.18|0.54|
91627118|NCT03803202|183146122|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.66|2.65|||t-test, 2 sided|||Serotype 14, Day 1||2.65|0.66|
91627119|NCT03803202|183146122|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.3|0.95|||t-test, 2 sided|||Serotype 18C, Day 1||0.95|0.30|
91627120|NCT03803202|183146122|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.73|2.57|||t-test, 2 sided|||Serotype 18C, Day 1||2.57|0.73|
91627121|NCT03803202|183146122|OTHER||Ratio of GMT|0.58|||||TWO_SIDED|95.0|0.32|1.04|||t-test, 2 sided|||Serotype 18C, Day 1||1.04|0.32|
91627122|NCT03803202|183146122|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.44|1.32|||t-test, 2 sided|||Serotype 19A, Day 1||1.32|0.44|
91627123|NCT03803202|183146122|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.66|2.01|||t-test, 2 sided|||Serotype 19A, Day 1||2.01|0.66|
91627124|NCT03803202|183146122|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.48|1.5|||t-test, 2 sided|||Serotype 19A, Day 1||1.50|0.48|
91627125|NCT03803202|183146122|OTHER||Ratio of GMT|0.79|||||TWO_SIDED|95.0|0.45|1.38|||t-test, 2 sided|||Serotype 19F, Day 1||1.38|0.45|
91627126|NCT03803202|183146122|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.47|1.52|||t-test, 2 sided|||Serotype 19F, Day 1||1.52|0.47|
91627127|NCT03803202|183146122|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.34|1.12|||t-test, 2 sided|||Serotype 19F, Day 1||1.12|0.34|
91627128|NCT03803202|183146122|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.64|1.94|||t-test, 2 sided|||Serotype 23F, Day 1||1.94|0.64|
91627129|NCT03803202|183146122|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.77|2.42|||t-test, 2 sided|||Serotype 23F, Day 1||2.42|0.77|
91627130|NCT03803202|183146122|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.66|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.66|
91663993|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.59
91663994|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.13
91663995|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.65
91663996|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.33
91663997|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.053|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.053
91663998|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.51
91663999|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.50
91664000|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.27
91664001|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.091
91664002|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.087|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.087
91664003|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
91664004|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
91664005|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.12
91664006|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.085
91714065|NCT02782741|183319783|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|106.97|STANDARD_ERROR_OF_MEAN|67.17||0.115|TWO_SIDED|95.0|-26.56|240.5|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for HHD lower extremity muscle strength composite score adjusted for summary HHD lower extremity score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||240.50|-26.56|0.1150
91664007|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.080
91664008|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.24
91664009|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.035|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.035
91664010|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.024
91792066|NCT02360605|183461851|SUPERIORITY|||||||0.97||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.97
91525344|NCT00152009|182925986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
91664011|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.30
91664012|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.89|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.89
91525345|NCT00152009|182925986|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
91525346|NCT00152009|182925987|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91525347|NCT00152009|182925987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Cochran-Mantel-Haenszel|||||||0.0016
91664013|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.80
91664014|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.75
91664015|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.060
91664016|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.12
91664017|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.13
91664018|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.78
91664019|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.70
91664020|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.98
91664021|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||CP: P value was calculated using ANOVA.||||0.76
91664022|NCT00205777|183222255|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.73
91664023|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.70
91664024|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.65
91664025|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.006
91664026|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||OV: P value was calculated using ANOVA.||||0.010
91664027|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.050
91664028|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.045
91664029|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.18
91664030|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.56
91664031|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.14
91664032|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.22
91664033|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.11
91664034|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.055
91664035|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.069
91664036|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.28
91664037|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.62
91627131|NCT03803202|183146122|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.47|1.47|||t-test, 2 sided|||Serotype 1, Day 30||1.47|0.47|
91627132|NCT03803202|183146122|OTHER||Ratio of GMT|0.87|||||TWO_SIDED|95.0|0.5|1.53|||t-test, 2 sided|||Serotype 1, Day 30||1.53|0.50|
91627133|NCT03803202|183146122|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.74|2.2|||t-test, 2 sided|||Serotype 1, Day 30||2.20|0.74|
91627134|NCT03803202|183146122|OTHER||Ratio of GMT|25.03|||||TWO_SIDED|95.0|16.33|38.34|||t-test, 2 sided|||Serotype 2, Day 30||38.34|16.33|
91627135|NCT03803202|183146122|OTHER||Ratio of GMT|21.99|||||TWO_SIDED|95.0|14.31|33.77|||t-test, 2 sided|||Serotype 2, Day 30||33.77|14.31|
91627136|NCT03803202|183146122|OTHER||Ratio of GMT|35.38|||||TWO_SIDED|95.0|23.09|54.22|||t-test, 2 sided|||Serotype 2, Day 30||54.22|23.09|
91627137|NCT03803202|183146122|OTHER||Ratio of GMT|1.81|||||TWO_SIDED|95.0|1.25|2.62|||t-test, 2 sided|||Serotype 3, Day 30||2.62|1.25|
91627138|NCT03803202|183146122|OTHER||Ratio of GMT|2.55|||||TWO_SIDED|95.0|1.83|3.56|||t-test, 2 sided|||Serotype 3, Day 30||3.56|1.83|
91627139|NCT03803202|183146122|OTHER||Ratio of GMT|3.14|||||TWO_SIDED|95.0|2.2|4.48|||t-test, 2 sided|||Serotype 3, Day 30||4.48|2.20|
91627140|NCT03803202|183146122|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.59|1.62|||t-test, 2 sided|||Serotype 4, Day 30||1.62|0.59|
91792067|NCT02757950|183461854|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.548||||0.1147|TWO_SIDED|95.0|0.259|1.157||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.157|0.259|0.1147
91627141|NCT03803202|183146122|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 4, Day 30||1.51|0.59|
91627142|NCT03803202|183146122|OTHER||Ratio of GMT|1.23|||||TWO_SIDED|95.0|0.76|1.99|||t-test, 2 sided|||Serotype 4, Day 30||1.99|0.76|
91627143|NCT03803202|183146122|OTHER||Ratio of GMT|1.25|||||TWO_SIDED|95.0|0.71|2.21|||t-test, 2 sided|||Serotype 5, Day 30||2.21|0.71|
91627144|NCT03803202|183146122|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.85|2.46|||t-test, 2 sided|||Serotype 5, Day 30||2.46|0.85|
91627145|NCT03803202|183146122|OTHER||Ratio of GMT|2.15|||||TWO_SIDED|95.0|1.25|3.72|||t-test, 2 sided|||Serotype 5, Day 30||3.72|1.25|
91627146|NCT03803202|183146122|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 6B, Day 30||1.51|0.59|
91627147|NCT03803202|183146122|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.56|1.29|||t-test, 2 sided|||Serotype 6B, Day 30||1.29|0.56|
91627148|NCT03803202|183146122|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.54|1.3|||t-test, 2 sided|||Serotype 6B, Day 30||1.30|0.54|
91627149|NCT03803202|183146122|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.61|1.18|||t-test, 2 sided|||Serotype 7F, Day 30||1.18|0.61|
91627150|NCT03803202|183146122|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.65|1.21|||t-test, 2 sided|||Serotype 7F, Day 30||1.21|0.65|
91627151|NCT03803202|183146122|OTHER||Ratio of GMT|1.05|||||TWO_SIDED|95.0|0.73|1.5|||t-test, 2 sided|||Serotype 7F, Day 30||1.50|0.73|
91627152|NCT03803202|183146122|OTHER||Ratio of GMT|19.46|||||TWO_SIDED|95.0|12.26|30.87|||t-test, 2 sided|||Serotype 8, Day 30||30.87|12.26|
91627153|NCT03803202|183146122|OTHER||Ratio of GMT|19.65|||||TWO_SIDED|95.0|12.07|32.0|||t-test, 2 sided|||Serotype 8, Day 30||32.00|12.07|
91627154|NCT03803202|183146122|OTHER||Ratio of GMT|41.87|||||TWO_SIDED|95.0|26.2|66.9|||t-test, 2 sided|||Serotype 8, Day 30||66.90|26.20|
91627155|NCT03803202|183146122|OTHER||Ratio of GMT|4.75|||||TWO_SIDED|95.0|3.06|7.36|||t-test, 2 sided|||Serotype 9N, Day 30||7.36|3.06|
91627156|NCT03803202|183146122|OTHER||Ratio of GMT|5.66|||||TWO_SIDED|95.0|3.83|8.37|||t-test, 2 sided|||Serotype 9N, Day 30||8.37|3.83|
91627157|NCT03803202|183146122|OTHER||Ratio of GMT|7.84|||||TWO_SIDED|95.0|5.19|11.82|||t-test, 2 sided|||Serotype 9N, Day 30||11.82|5.19|
91627158|NCT03803202|183146122|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.49|1.42|||t-test, 2 sided|||Serotype 9V, Day 30||1.42|0.49|
91627159|NCT03803202|183146122|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.44|1.14|||t-test, 2 sided|||Serotype 9V, Day 30||1.14|0.44|
91627160|NCT03803202|183146122|OTHER||Ratio of GMT|1.21|||||TWO_SIDED|95.0|0.76|1.95|||t-test, 2 sided|||Serotype 9V, Day 30||1.95|0.76|
91627161|NCT03803202|183146122|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.21|||t-test, 2 sided|||Serotype 6A, Day 30||1.21|0.39|
91627162|NCT03803202|183146122|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.5|||t-test, 2 sided|||Serotype 6A, Day 30||1.50|0.54|
91627163|NCT03803202|183146122|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.53|1.64|||t-test, 2 sided|||Serotype 6A, Day 30||1.64|0.53|
91627164|NCT03803202|183146122|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.84|2.11|||t-test, 2 sided|||Serotype 14, Day 30||2.11|0.84|
91627165|NCT03803202|183146122|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.43|||t-test, 2 sided|||Serotype 14, Day 30||1.43|0.55|
91627166|NCT03803202|183146122|OTHER||Ratio of GMT|1.54|||||TWO_SIDED|95.0|0.95|2.5|||t-test, 2 sided|||Serotype 14, Day 30||2.50|0.95|
91627167|NCT03803202|183146122|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.44|||t-test, 2 sided|||Serotype 18C, Day 30||1.44|0.55|
91627168|NCT03803202|183146122|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.63|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.63|
91627169|NCT03803202|183146122|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.82|2.12|||t-test, 2 sided|||Serotype 18C, Day 30||2.12|0.82|
91627170|NCT03803202|183146122|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.7|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.70|
91627171|NCT03803202|183146122|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.71|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.71|
91627172|NCT03803202|183146122|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.78|1.67|||t-test, 2 sided|||Serotype 19A, Day 30||1.67|0.78|
91627173|NCT03803202|183146122|OTHER||Ratio of GMT|1.52||||||95.0|0.99|2.32|||t-test, 2 sided|||Serotype 19F, Day 30||2.32|0.99|
91664038|NCT00205777|183222256|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.96
91627174|NCT03803202|183146122|OTHER||Ratio of GMT|1.48|||||TWO_SIDED|95.0|1.0|2.18|||t-test, 2 sided|||Serotype 19F, Day 30||2.18|1.00|
91627175|NCT03803202|183146122|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.35|3.22|||t-test, 2 sided|||Serotype 19F, Day 30||3.22|1.35|
91627176|NCT03803202|183146122|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.36|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.36|
91627177|NCT03803202|183146122|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.4|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.40|
91627178|NCT03803202|183146122|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.47|1.73|||t-test, 2 sided|||Serotype 23F, Day 30||1.73|0.47|
91627179|NCT03803202|183146123|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.57|1.42|||t-test, 2 sided|||Serotype 1, Day 1||1.42|0.57|
91627180|NCT03803202|183146123|OTHER||Ratio of GMC|1.85|||||TWO_SIDED|95.0|1.12|3.08|||t-test, 2 sided|||Serotype 1, Day 1||3.08|1.12|
91664039|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.22
91627181|NCT03803202|183146123|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.49|||t-test, 2 sided|||Serotype 1, Day 1||1.49|0.53|
91627182|NCT03803202|183146123|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.84|1.87|||t-test, 2 sided|||Serotype 3, Day 1||1.87|0.84|
91664040|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.087
91664041|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.37
91664042|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.73
91664043|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.41
91664044|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.085
91525348|NCT00152009|182925987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
91525349|NCT00152009|182925988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91525350|NCT00152009|182925988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||95.0|||||Cochran-Mantel-Haenszel|||||||0.0013
91627183|NCT03803202|183146123|OTHER||Ratio of GMC|1.79|||||TWO_SIDED|95.0|1.18|2.73|||t-test, 2 sided|||Serotype 3, Day 1||2.73|1.18|
91627184|NCT03803202|183146123|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.69|1.69|||t-test, 2 sided|||Serotype 3, Day 1||1.69|0.69|
91627185|NCT03803202|183146123|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.54|1.21|||t-test, 2 sided|||Serotype 4, Day 1||1.21|0.54|
91627186|NCT03803202|183146123|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.74|1.81|||t-test, 2 sided|||Serotype 4, Day 1||1.81|0.74|
91627187|NCT03803202|183146123|OTHER||Ratio of GMC|0.67|||||TWO_SIDED|95.0|0.44|1.0|||t-test, 2 sided|||Serotype 4, Day 1||1.00|0.44|
91627188|NCT03803202|183146123|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.65|1.78|||t-test, 2 sided|||Serotype 5, Day 1||1.78|0.65|
91627189|NCT03803202|183146123|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.96|2.63|||t-test, 2 sided|||Serotype 5, Day 1||2.63|0.96|
91627190|NCT03803202|183146123|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.58|1.72|||t-test, 2 sided|||Serotype 5, Day 1||1.72|0.58|
91627191|NCT03803202|183146123|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.47|||t-test, 2 sided|||Serotype 6A, Day 1||1.47|0.53|
91627192|NCT03803202|183146123|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.83|2.3|||t-test, 2 sided|||Serotype 6A, Day 1||2.30|0.83|
91627193|NCT03803202|183146123|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.8|2.44|||t-test, 2 sided|||Serotype 6A, Day 1||2.44|0.80|
91627194|NCT03803202|183146123|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.69|1.99|||t-test, 2 sided|||Serotype 6B, Day 1||1.99|0.69|
91627195|NCT03803202|183146123|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|1.19|3.67|||t-test, 2 sided|||Serotype 6B, Day 1||3.67|1.19|
91627196|NCT03803202|183146123|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.88|2.88|||t-test, 2 sided|||Serotype 6B, Day 1||2.88|0.88|
91627197|NCT03803202|183146123|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.62|1.65|||t-test, 2 sided|||Serotype 7F, Day 1||1.65|0.62|
91627198|NCT03803202|183146123|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.94|2.67|||t-test, 2 sided|||Serotype 7F, Day 1||2.67|0.94|
91627199|NCT03803202|183146123|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.5|1.64|||t-test, 2 sided|||Serotype 7F, Day 1||1.64|0.50|
91627200|NCT03803202|183146123|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.52|1.21|||t-test, 2 sided|||Serotype 9V, Day 1||1.21|0.52|
91627201|NCT03803202|183146123|OTHER||Ratio of GMC|1.57|||||TWO_SIDED|95.0|0.97|2.54|||t-test, 2 sided|||Serotype 9V, Day 1||2.54|0.97|
91627202|NCT03803202|183146123|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.6|1.6|||t-test, 2 sided|||Serotype 9V, Day 1||1.60|0.60|
91627203|NCT03803202|183146123|OTHER||Ratio of GMC|0.73|||||TWO_SIDED|95.0|0.4|1.33|||t-test, 2 sided|||Serotype 14, Day 1||1.33|0.40|
91627204|NCT03803202|183146123|OTHER||Ratio of GMC|1.33|||||TWO_SIDED|95.0|0.73|2.44|||t-test, 2 sided|||Serotype 14, Day 1||2.44|0.73|
91627205|NCT03803202|183146123|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.46|1.63|||t-test, 2 sided|||Serotype 14, Day 1||1.63|0.46|
91627206|NCT03803202|183146123|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.42|1.12|||t-test, 2 sided|||Serotype 18C, Day 1||1.12|0.42|
91664045|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.15
91664046|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.71
91664047|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.042
91664048|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.077
91664049|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.35
91664050|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.12
91664051|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.41
91664052|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.90
91664053|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.46
91664054|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.18
91482394|NCT00510952|182838632|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per liter (mmol/L).|Mean Difference (Net)|0.06||||0.323||95.0|-0.06|0.19|||ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatment groups (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Insulin lispro protamine suspension is noninferior to glargine at actual morning pre-meal at endpoint.||0.19|-0.06|0.323
91482395|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for Actual Morning Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.302
91482396|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Actual Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.144
91482397|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for Actual Midday Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.279
91482398|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value for Actual Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.928
91525351|NCT00152009|182925988|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91627207|NCT03803202|183146123|OTHER||Ratio of GMC|1.53|||||TWO_SIDED|95.0|0.92|2.55|||t-test, 2 sided|||Serotype 18C, Day 1||2.55|0.92|
91664055|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.75
91714066|NCT02782741|183319784|OTHER|No formal testing of additional secondary endpoint of QMFT.|LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|0.94||0.0288|TWO_SIDED|95.0|0.22|3.95||Nominal p-value.|mixed model for repeated measures|||LS mean difference was derived from MMRM models adjust for total QMFT score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.95|0.22|0.0288
91627208|NCT03803202|183146123|OTHER||Ratio of GMC|0.78|||||TWO_SIDED|95.0|0.44|1.37|||t-test, 2 sided|||Serotype 18C, Day 1||1.37|0.44|
91482399|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-value for Actual Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.918
91482400|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value for Actual Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.875
91482401|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Actual 0300 Hours.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.316
91482402|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-value for Daily Mean 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.389
91482403|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Daily Mean Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.836
91482404|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Daily Mean Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.394
91482405|NCT00510952|182838633|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Daily Mean Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.609
91482406|NCT00510952|182838634|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for All Hypoglycemic Episodes.|Fisher Exact|||||||0.468
91482407|NCT00510952|182838634|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.011
91482408|NCT00510952|182838634|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.036
91482409|NCT00510952|182838635|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.316
91482410|NCT00510952|182838635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||<0.001
91525352|NCT00152009|182925989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1438||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1438
91627209|NCT03803202|183146123|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.54|1.25|||t-test, 2 sided|||Serotype 19A, Day 1||1.25|0.54|
91627210|NCT03803202|183146123|OTHER||Ratio of GMC|1.34|||||TWO_SIDED|95.0|0.84|2.12|||t-test, 2 sided|||Serotype 19A, Day 1||2.12|0.84|
91627211|NCT03803202|183146123|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.66|||t-test, 2 sided|||Serotype 19A, Day 1||1.66|0.66|
91627212|NCT03803202|183146123|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.37|||t-test, 2 sided|||Serotype 19F, Day 1||1.37|0.51|
91627213|NCT03803202|183146123|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.75|2.11|||t-test, 2 sided|||Serotype 19F, Day 1||2.11|0.75|
91627214|NCT03803202|183146123|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.57|1.72|||t-test, 2 sided|||Serotype 19F, Day 1||1.72|0.57|
91664056|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.10
91664057|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.79
91664058|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.057
91664059|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.17
91664060|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.46
91664061|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.83
91714067|NCT02782741|183319785|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|0.77|STANDARD_ERROR_OF_MEAN|1.46||0.5996|TWO_SIDED|95.0|-2.13|3.67|||mixed model for repeated measures|||The MMRM models adjust for baseline score (PCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.67|-2.13|0.5996
91627215|NCT03803202|183146123|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.63|1.86|||t-test, 2 sided|||Serotype 23F, Day 1||1.86|0.63|
91627216|NCT03803202|183146123|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.69|2.08|||t-test, 2 sided|||Serotype 23F, Day 1||2.08|0.69|
91627217|NCT03803202|183146123|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.67|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.67|
91627218|NCT03803202|183146123|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.52|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.52|
91627219|NCT03803202|183146123|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.68|1.59|||t-test, 2 sided|||Serotype 1, Day 30||1.59|0.68|
91627220|NCT03803202|183146123|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.76|1.8|||t-test, 2 sided|||Serotype 1, Day 30||1.80|0.76|
91627221|NCT03803202|183146123|OTHER||Ratio of GMC|2.07|||||TWO_SIDED|95.0|1.42|3.01|||t-test, 2 sided|||Serotype 3, Day 30||3.01|1.42|
91627222|NCT03803202|183146123|OTHER||Ratio of GMC|3.29|||||TWO_SIDED|95.0|2.37|4.58|||t-test, 2 sided|||Serotype 3, Day 30||4.58|2.37|
91627223|NCT03803202|183146123|OTHER||Ratio of GMC|4.05|||||TWO_SIDED|95.0|2.83|5.79|||t-test, 2 sided|||Serotype 3, Day 30||5.79|2.83|
91627224|NCT03803202|183146123|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.49|1.27|||t-test, 2 sided|||Serotype 4, Day 30||1.27|0.49|
91627225|NCT03803202|183146123|OTHER||Ratio of GMC|0.97|||||TWO_SIDED|95.0|0.63|1.48|||t-test, 2 sided|||Serotype 4, Day 30||1.48|0.63|
91627226|NCT03803202|183146123|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.65|||t-test, 2 sided|||Serotype 4, Day 30||1.65|0.66|
91627227|NCT03803202|183146123|OTHER||Ratio of GMC|1.31|||||TWO_SIDED|95.0|0.75|2.29|||t-test, 2 sided|||Serotype 5, Day 30||2.29|0.75|
91627228|NCT03803202|183146123|OTHER||Ratio of GMC|1.3|||||TWO_SIDED|95.0|0.77|2.19|||t-test, 2 sided|||Serotype 5, Day 30||2.19|0.77|
91627229|NCT03803202|183146123|OTHER||Ratio of GMC|1.91|||||TWO_SIDED|95.0|1.08|3.37|||t-test, 2 sided|||Serotype 5, Day 30||3.37|1.08|
91627230|NCT03803202|183146123|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.49|||t-test, 2 sided|||Serotype 6A, Day 30||1.49|0.50|
91627231|NCT03803202|183146123|OTHER||Ratio of GMC|1.06|||||TWO_SIDED|95.0|0.65|1.72|||t-test, 2 sided|||Serotype 6A, Day 30||1.72|0.65|
91627232|NCT03803202|183146123|OTHER||Ratio of GMC|1.22|||||TWO_SIDED|95.0|0.71|2.1|||t-test, 2 sided|||Serotype 6A, Day 30||2.10|0.71|
91627233|NCT03803202|183146123|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.56|1.75|||t-test, 2 sided|||Serotype 6B, Day 30||1.75|0.56|
91627234|NCT03803202|183146123|OTHER||Ratio of GMC|1.44|||||TWO_SIDED|95.0|0.84|2.47|||t-test, 2 sided|||Serotype 6B, Day 30||2.47|0.84|
91627235|NCT03803202|183146123|OTHER||Ratio of GMC|1.77|||||TWO_SIDED|95.0|1.0|3.15|||t-test, 2 sided|||Serotype 6B, Day 30||3.15|1.00|
91627236|NCT03803202|183146123|OTHER||Ratio of GMC|1.54|||||TWO_SIDED|95.0|1.02|2.3|||t-test, 2 sided|||Serotype 7F, Day 30||2.30|1.02|
91627237|NCT03803202|183146123|OTHER||Ratio of GMC|1.55|||||TWO_SIDED|95.0|1.06|2.26|||t-test, 2 sided|||Serotype 7F, Day 30||2.26|1.06|
91627238|NCT03803202|183146123|OTHER||Ratio of GMC|1.66|||||TWO_SIDED|95.0|1.09|2.53|||t-test, 2 sided|||Serotype 7F, Day 30||2.53|1.09|
91627239|NCT03803202|183146123|OTHER||Ratio of GMC|1.29|||||TWO_SIDED|95.0|0.81|2.07|||t-test, 2 sided|||Serotype 9V, Day 30||2.07|0.81|
91627240|NCT03803202|183146123|OTHER||Ratio of GMC|1.64|||||TWO_SIDED|95.0|1.04|2.57|||t-test, 2 sided|||Serotype 9V, Day 30||2.57|1.04|
91627241|NCT03803202|183146123|OTHER||Ratio of GMC|2.16|||||TWO_SIDED|95.0|1.35|3.47|||t-test, 2 sided|||Serotype 9V, Day 30||3.47|1.35|
91627242|NCT03803202|183146123|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 14, Day 30||1.68|0.58|
91627243|NCT03803202|183146123|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.77|2.05|||t-test, 2 sided|||Serotype 14, Day 30||2.05|0.77|
91627244|NCT03803202|183146123|OTHER||Ratio of GMC|1.67|||||TWO_SIDED|95.0|0.99|2.81|||t-test, 2 sided|||Serotype 14, Day 30||2.81|0.99|
91627245|NCT03803202|183146123|OTHER||Ratio of GMC|0.61|||||TWO_SIDED|95.0|0.39|0.95|||t-test, 2 sided|||Serotype 18C, Day 30||0.95|0.39|
91627246|NCT03803202|183146123|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.7|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.70|
91627247|NCT03803202|183146123|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.67|1.57|||t-test, 2 sided|||Serotype 18C, Day 30||1.57|0.67|
91627248|NCT03803202|183146123|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.56|1.25|||t-test, 2 sided|||Serotype 19A, Day 30||1.25|0.56|
91627249|NCT03803202|183146123|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.75|1.52|||t-test, 2 sided|||Serotype 19A, Day 30||1.52|0.75|
91627250|NCT03803202|183146123|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.77|1.86|||t-test, 2 sided|||Serotype 19A, Day 30||1.86|0.77|
91627251|NCT03803202|183146123|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.76|1.9|||t-test, 2 sided|||Serotype 19F, Day 30||1.90|0.76|
91627252|NCT03803202|183146123|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|1.11|2.58|||t-test, 2 sided|||Serotype 19F, Day 30||2.58|1.11|
91627253|NCT03803202|183146123|OTHER||Ratio of GMC|2.23|||||TWO_SIDED|95.0|1.41|3.52|||t-test, 2 sided|||Serotype 19F, Day 30||3.52|1.41|
91627254|NCT03803202|183146123|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.47|||t-test, 2 sided|||Serotype 23F, Day 30||1.47|0.50|
91627255|NCT03803202|183146123|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.35|||t-test, 2 sided|||Serotype 23F, Day 30||1.35|0.51|
91627256|NCT03803202|183146123|OTHER||Ratio of GMC|1.18|||||TWO_SIDED|95.0|0.69|2.02|||t-test, 2 sided|||Serotype 23F, Day 30||2.02|0.69|
91627257|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.4|0.805
91627258|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.102|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.102
91627259|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.158|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.158
91627260|NCT03803202|183146126|OTHER||Mean Difference|-0.1||||0.596|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Serotype 2, Day 30||0.2|-0.4|0.596
91627261|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.025|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.025
91627262|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.005|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.1|0.005
91627263|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.037|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 3, Day 30||0.7|0.0|0.037
91627264|NCT03803202|183146126|OTHER||Mean Difference|0.6||||0.002|TWO_SIDED|95.0|0.2|0.9|||ANCOVA|||Serotype 3, Day 30||0.9|0.2|0.002
91627265|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.23|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.230
91627266|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 4, Day 30||0.4|-0.4|0.984
91627267|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.262
91664062|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.25
91482411|NCT00510952|182838635|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.102
91627268|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.264|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.264
91627269|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.638|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 5, Day 30||0.6|-0.4|0.638
91664063|NCT00205777|183222257|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.35
91664064|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.018
91482412|NCT00510952|182838637|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|-0.01||||0.975||95.0|-0.61|0.59||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: insulin lispro protamine suspension is noninferior to glargine with regard to change in absolute body weight from baseline to endpoint.||0.59|-0.61|0.975
91627270|NCT03803202|183146126|OTHER||Mean Difference|0.5||||0.036|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 5, Day 30||1.0|0.0|0.036
91627271|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.094|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.094
91627272|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.266|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.266
91627273|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.25|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.250
91627274|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.927|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Serotype 6A, Day 30||0.5|-0.5|0.927
91627275|NCT03803202|183146126|OTHER||Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.5|0.679
91627276|NCT03803202|183146126|OTHER||Mean Difference|-0.1||||0.589|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.6|0.589
91627277|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.88|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 6B, Day 30||0.4|-0.5|0.880
91627278|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.623|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.2|0.623
91627279|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.232|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 7F, Day 30||0.6|-0.1|0.232
91627280|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.451|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.2|0.451
91627281|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.785|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.785
91627282|NCT03803202|183146126|OTHER||Mean Difference|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
91627283|NCT03803202|183146126|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
91627284|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.1|0.146
91627285|NCT03803202|183146126|OTHER||Mean Difference|0.5||||0.003|TWO_SIDED|95.0|0.2|0.8|||ANCOVA|||Serotype 9N, Day 30||0.8|0.2|0.003
91627286|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.113|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9N, Day 30||0.6|-0.1|0.113
91627287|NCT03803202|183146126|OTHER||Mean Difference|-0.2||||0.453|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 9V, Day 30||0.3|-0.6|0.453
91627288|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 9V, Day 30||0.8|-0.1|0.111
91627289|NCT03803202|183146126|OTHER||Mean Difference|0.5||||0.02|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 9V, Day 30||1.0|0.1|0.020
91627290|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.218|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.218
91627291|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.125|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 10A, Day 30||0.9|-0.1|0.125
91627292|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.706|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.4|0.706
91627293|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.246|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 11A, Day 30||0.6|-0.1|0.246
91664065|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.29
91664066|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.049
91664067|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.37
91664068|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.97
91664069|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.78
91664070|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.43
91664071|NCT00205777|183222258|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.32
91664072|NCT00205777|183222259|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANOVA|||||||0.35
91664073|NCT00205777|183222259|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
91482413|NCT00510952|182838638|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.031
91627294|NCT03803202|183146126|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.1|||ANCOVA|||Serotype 11A, Day 30||1.1|0.3|<.001
91627295|NCT03803202|183146126|OTHER||Mean Difference|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 11A, Day 30||0.9|0.1|0.010
91627296|NCT03803202|183146126|OTHER||Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Serotype 12F, Day 30||0.2|-0.7|0.260
91627297|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.366|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.3|0.366
91627298|NCT03803202|183146126|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 12F, Day 30||1.0|0.0|0.046
91627299|NCT03803202|183146126|OTHER||Mean Difference|-0.4||||0.101|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Serotype 14, Day 30||0.1|-0.8|0.101
91664074|NCT00205777|183222259|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||||||0.30
91664075|NCT00205777|183222259|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||||||0.95
91664076|NCT00205777|183222259|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
91664077|NCT00205777|183222260|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||ANOVA|||||||1.00
91714068|NCT02782741|183319785|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|2.12|STANDARD_ERROR_OF_MEAN|1.8||0.2427|TWO_SIDED|95.0|-1.46|5.69|||mixed model for repeated measures|||The MMRM models adjust for baseline score (MCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||5.69|-1.46|0.2427
91714069|NCT01275144|183319799|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|0.897|||||TWO_SIDED|90.0|0.86|0.94|||||Ratio of LY2216684 to Placebo|||0.94|0.86|
91482414|NCT00510952|182838639|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.015
91482415|NCT02338336|182838640|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91482416|NCT00396032|182838729|SUPERIORITY_OR_OTHER|||||||0.0044||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0044
91482417|NCT00396032|182838729|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||Chi-squared|||||||0.0035
91482418|NCT00396032|182838731|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0396
91482419|NCT04090957|182838743|SUPERIORITY||Least square mean difference|-8.42||||0.0436|TWO_SIDED|95.0|-16.64|-0.2|||Mixed Model for Repeated Measures|||1\_Week 4; E4 15 mg vs Placebo||-0.20|-16.64|0.0436
91627300|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.522||95.0|-0.3|0.6|||ANCOVA|||Serotype 14, Day 30||0.6|-0.3|0.522
91627301|NCT03803202|183146126|OTHER||Mean Difference|0.5||||0.026|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.1|0.026
91627302|NCT03803202|183146126|OTHER||Mean Difference|-0.2||||0.236|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Serotype 15B, Day 30||0.2|-0.6|0.236
91627303|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 15B, Day 30||0.5|-0.3|0.528
91627304|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.081|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 15B, Day 30||0.8|0.0|0.081
91627305|NCT03803202|183146126|OTHER||Mean Difference|-0.1||||0.388|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Serotype 17F, Day 30||0.2|-0.5|0.388
91627306|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.151|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.151
91627307|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.024|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 17F, Day 30||0.7|0.1|0.024
91627308|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.476|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 18C, Day 30||0.5|-0.3|0.476
91627309|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.077|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 18C, Day 30||0.8|0.0|0.077
91627310|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 18C, Day 30||0.6|-0.2|0.262
91627311|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.767|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 19A, Day 30||0.4|-0.3|0.767
91627312|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.364
91627313|NCT03803202|183146126|OTHER||Mean Difference|0.1||||0.522|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.522
91627314|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.962|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 19F, Day 30||0.4|-0.4|0.962
91664078|NCT00205777|183222260|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||||||0.40
91664079|NCT00205777|183222261|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
91664080|NCT00205777|183222261|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
91664081|NCT00205777|183222261|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
91664082|NCT00205777|183222261|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||||||0.92
91664083|NCT00205777|183222261|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANOVA|||||||0.50
91664084|NCT00205777|183222262|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||||||0.73
91664085|NCT00205777|183222262|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
91664086|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.81
91664087|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.96
91664088|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.005
91664089|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.013
91664090|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.006
91664091|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.70
91664092|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.44
91664093|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.47
91664094|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.28
91627315|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.091|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.091
91627316|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.093|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.093
91627317|NCT03803202|183146126|OTHER||Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 20B, Day 30||0.3|-0.6|0.455
91627318|NCT03803202|183146126|OTHER||Mean Difference|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|-0.1|0.093
91627319|NCT03803202|183146126|OTHER||Mean Difference|0.6||||0.017|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Serotype 20B, Day 30||1.1|0.1|0.017
91627320|NCT03803202|183146126|OTHER||Mean Difference|-0.1||||0.561|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 22F, Day 30||0.3|-0.5|0.561
91627321|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.343|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 22F, Day 30||0.6|-0.2|0.343
91627322|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.132|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 22F, Day 30||0.7|-0.1|0.132
91627323|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 23F, Day 30||0.6|-0.5|0.898
91627324|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.313|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||Serotype 23F, Day 30||0.9|-0.3|0.313
91627325|NCT03803202|183146126|OTHER||Mean Difference|0.3||||0.366|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.3|0.366
91482420|NCT04090957|182838743|SUPERIORITY||Least square mean difference|-10.21||||0.0117|TWO_SIDED|95.0|-18.44|-1.98|||Mixed Model for Repeated Measures|||2\_Week 4; E4 20 mg vs Placebo||-1.98|-18.44|0.0117
91627326|NCT03803202|183146126|OTHER||Mean Difference|0.0||||0.961|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.961
91627327|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.269|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.269
91627328|NCT03803202|183146126|OTHER||Mean Difference|0.2||||0.245|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.245
91627329|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.213|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 1, Day 30||0.7|-0.1|0.213
91627330|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.097|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 1, Day 30||0.8|-0.1|0.097
91627331|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.631|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.3|0.631
91627332|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 2, Day 30||0.4|-0.3|0.699
91627333|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.042|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.042
91627334|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.092|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|-0.1|0.092
91627335|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.007|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 3, Day 30||0.8|0.1|0.007
91627336|NCT03803202|183146127|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 3, Day 30||1.0|0.3|<.001
91627337|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.237|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.237
91627338|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.248|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.248
91627339|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.193|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 4, Day 30||0.7|-0.1|0.193
91627340|NCT03803202|183146127|OTHER||Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 4, Day 30||0.5|-0.4|0.838
91627341|NCT03803202|183146127|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 5, Day 30||0.4|-0.5|0.898
91627342|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.143|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.143
91627343|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.108|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.108
91627344|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.396|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 6A, Day 30||0.7|-0.3|0.396
91627345|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.182|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6A, Day 30||0.9|-0.2|0.182
91627346|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.593|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 6A, Day 30||0.6|-0.4|0.593
91627347|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6B, Day 30||0.9|-0.2|0.186
91627348|NCT03803202|183146127|OTHER||Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Serotype 6B, Day 30||1.1|0.0|0.038
91627349|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.408|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 6B, Day 30||0.8|-0.3|0.408
91627350|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.3|0.805
91664095|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.14
91664096|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.93
91664097|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.85
91664098|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.010
91664099|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.015
91664100|NCT00205777|183222263|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.006
91664101|NCT00205777|183222264|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.60
91664102|NCT00205777|183222264|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.53
91664103|NCT00205777|183222264|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||1.00
91664104|NCT00205777|183222264|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.43
91664105|NCT00205777|183222264|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.60
91664106|NCT00205777|183222264|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.52
91482421|NCT04090957|182838743|SUPERIORITY||Least square mean difference|-12.2||||0.0029|TWO_SIDED|95.0|-20.69|-3.71|||Mixed Model for Repeated Measures|||3\_Week 12; E4 15 mg vs Placebo||-3.71|-20.69|0.0029
91627351|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.711|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.3|0.711
91627352|NCT03803202|183146127|OTHER||Mean Difference|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.4|0.891
91627353|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.649|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.649
91627354|NCT03803202|183146127|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 8, Day 30||1.0|0.3|<.001
91627355|NCT03803202|183146127|OTHER||Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|0.3|0.9|||ANCOVA|||Serotype 8, Day 30||0.9|0.3|<.001
91627356|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.454|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.2|0.454
91627357|NCT03803202|183146127|OTHER||Mean Difference|0.6||||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 9N, Day 30||1.0|0.2|0.003
91627358|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.021|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9N, Day 30||0.9|0.1|0.021
91627359|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.205|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9V, Day 30||0.6|-0.1|0.205
91627360|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.015|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9V, Day 30||0.9|0.1|0.015
91627361|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.209|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 9V, Day 30||0.7|-0.1|0.209
91627362|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.502|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.3|0.502
91627363|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.054|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 10A, Day 30||1.0|0.0|0.054
91627364|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.190
91627365|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 11A, Day 30||0.4|-0.3|0.616
91627366|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.018|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 11A, Day 30||0.8|0.1|0.018
91627367|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.056|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 11A, Day 30||0.7|0.0|0.056
91627368|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.527|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.4|0.527
91627369|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.444|TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||Serotype 12F, Day 30||0.8|-0.4|0.444
91627370|NCT03803202|183146127|OTHER||Mean Difference|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 12F, Day 30||0.6|-0.5|0.869
91627371|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.305|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 14, Day 30||0.7|-0.2|0.305
91627372|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.0|0.046
91627373|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.299|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 14, Day 30||0.8|-0.2|0.299
91627374|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 15B, Day 30||0.7|-0.1|0.140
91627375|NCT03803202|183146127|OTHER||Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANCOVA|||Serotype 15B, Day 30||1.3|0.4|<.001
91627376|NCT03803202|183146127|OTHER||Mean Difference|0.6||||0.012|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 15B, Day 30||1.0|0.1|0.012
91627377|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.2|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.200
91627378|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.037|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 17F, Day 30||0.8|0.0|0.037
91627379|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.38|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.2|0.380
91627380|NCT03803202|183146127|OTHER||Mean Difference|0.6||||0.006|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.2|0.006
91627381|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.018|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.1|0.018
91627382|NCT03803202|183146127|OTHER||Mean Difference|-0.1||||0.81|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 18C, Day 30||0.4|-0.5|0.810
91627383|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.173|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19A, Day 30||0.7|-0.1|0.173
91627384|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.096|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19A, Day 30||0.8|-0.1|0.096
91627385|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.71|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.3|0.710
91627386|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.1|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19F, Day 30||0.8|-0.1|0.100
91627387|NCT03803202|183146127|OTHER||Mean Difference|0.6||||0.007|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||Serotype 19F, Day 30||1.1|0.2|0.007
91627388|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.251|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.2|0.251
91627389|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.618|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 20B, Day 30||0.5|-0.3|0.618
91627390|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.041|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|0.0|0.041
91627391|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 20B, Day 30||0.8|-0.1|0.111
91627392|NCT03803202|183146127|OTHER||Mean Difference|0.1||||0.758|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 22F, Day 30||0.4|-0.3|0.758
91627393|NCT03803202|183146127|OTHER||Mean Difference|0.5||||0.012|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 22F, Day 30||0.9|0.1|0.012
91627394|NCT03803202|183146127|OTHER||Mean Difference|0.4||||0.025|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 22F, Day 30||0.8|0.1|0.025
91627395|NCT03803202|183146127|OTHER||Mean Difference|0.0||||0.912|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 23F, Day 30||0.4|-0.5|0.912
91627396|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.174|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.174
91627397|NCT03803202|183146127|OTHER||Mean Difference|0.3||||0.138|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.138
91627398|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.267|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.267
91714070|NCT01275144|183319800|SUPERIORITY_OR_OTHER||median of paired differences|0.5||||0.0021|TWO_SIDED|90.0|0.5|1.0|||Wilcoxon signed rank test||Ratio of LY2216684 to Placebo|||1.00|0.50|0.0021
91714071|NCT01275144|183319801|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|1.01|1.08|||||Ratio of LY2216684 to Placebo|||1.08|1.01|
91627399|NCT03803202|183146127|OTHER||Mean Difference|0.2||||0.3|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.300
91627400|NCT03803202|183146127|OTHER||Mean Difference|0.0||||0.982|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.982
91627401|NCT03803202|183146128|OTHER||Ratio of GMT|1.49|||||TWO_SIDED|95.0|1.06|2.08|||t-test, 2 sided|||Serotype 2||2.08|1.06|
91627402|NCT03803202|183146128|OTHER||Ratio of GMT|0.97|||||TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|||Serotype 8||1.37|0.68|
91627403|NCT03803202|183146128|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.92|2.0|||t-test, 2 sided|||Serotype 9N||2.00|0.92|
91627404|NCT03803202|183146128|OTHER||Ratio of GMT|2.18|||||TWO_SIDED|95.0|1.25|3.79|||t-test, 2 sided|||Serotype 10A||3.79|1.25|
91627405|NCT03803202|183146128|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.8|1.77|||t-test, 2 sided|||Serotype 11A||1.77|0.80|
91627406|NCT03803202|183146128|OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.73|2.0|||t-test, 2 sided|||Serotype 12F||2.00|0.73|
91627407|NCT03803202|183146128|OTHER||Ratio of GMT|1.47|||||TWO_SIDED|95.0|0.94|2.29|||t-test, 2 sided|||Serotype 15B||2.29|0.94|
91627408|NCT03803202|183146128|OTHER||Ratio of GMT|2.61|||||TWO_SIDED|95.0|1.68|4.04|||t-test, 2 sided|||Serotype 17F||4.04|1.68|
91627409|NCT03803202|183146128|OTHER||Ratio of GMT|9.05|||||TWO_SIDED|95.0|5.65|14.5|||t-test, 2 sided|||Serotype 20B||14.50|5.65|
91714072|NCT05116202|183319823|SUPERIORITY||Difference in pRR|2.73|||||TWO_SIDED|95.0|-22.25|27.7||||||||27.70|-22.25|
91627410|NCT03803202|183146128|OTHER||Ratio of GMT|1.79|||||TWO_SIDED|95.0|1.09|2.95|||t-test, 2 sided|||Serotype 22F||2.95|1.09|
91627411|NCT03803202|183146128|OTHER|Serotype 33F|Ratio of GMT|1.34|||||TWO_SIDED|95.0|0.86|2.11|||t-test, 2 sided|||||2.11|0.86|
91627412|NCT03803202|183146128|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.93|1.83|||t-test, 2 sided|||Serotype 2||1.83|0.93|
91627413|NCT03803202|183146128|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.67|1.43|||t-test, 2 sided|||Serotype 8||1.43|0.67|
91627414|NCT03803202|183146128|OTHER||Ratio of GMT|1.62|||||TWO_SIDED|95.0|1.62|2.26|||t-test, 2 sided|||Serotype 9N||2.26|1.62|
91627415|NCT03803202|183146128|OTHER||Ratio of GMT|2.87|||||TWO_SIDED|95.0|1.68|4.9|||t-test, 2 sided|||Serotype 10A||4.90|1.68|
91627416|NCT03803202|183146128|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.06|||t-test, 2 sided|||Serotype 11A||2.06|0.98|
91627417|NCT03803202|183146128|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.48|||t-test, 2 sided|||Serotype 12F||1.48|0.54|
91627418|NCT03803202|183146128|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.73|1.64|||t-test, 2 sided|||Serotype 15B||1.64|0.73|
91627419|NCT03803202|183146128|OTHER||Ratio of GMT|2.13|||||TWO_SIDED|95.0|1.4|3.25|||t-test, 2 sided|||Serotype 17F||3.25|1.40|
91627420|NCT03803202|183146128|OTHER||Ratio of GMT|7.28|||||TWO_SIDED|95.0|4.61|11.5|||t-test, 2 sided|||Serotype 20B||11.50|4.61|
91627421|NCT03803202|183146128|OTHER||Ratio of GMT|1.55|||||TWO_SIDED|95.0|0.96|2.48|||t-test, 2 sided|||Serotype 22F||2.48|0.96|
91627422|NCT03803202|183146128|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.83|1.84|||t-test, 2 sided|||Serotype 33F||1.84|0.83|
91627423|NCT03803202|183146128|OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.51|2.94|||t-test, 2 sided|||Serotype 2||2.94|1.51|
91627424|NCT03803202|183146128|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.46|2.97|||t-test, 2 sided|||Serotype 8||2.97|1.46|
91627425|NCT03803202|183146128|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.56|3.2|||t-test, 2 sided|||Serotype 9N||3.20|1.56|
91627426|NCT03803202|183146128|OTHER||Ratio of GMT|3.24|||||TWO_SIDED|95.0|1.79|5.89|||t-test, 2 sided|||Serotype 10A||5.89|1.79|
91627427|NCT03803202|183146128|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.63|3.62|||t-test, 2 sided|||Serotype 11A||3.62|1.63|
91627428|NCT03803202|183146128|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|0.89|2.55|||t-test, 2 sided|||Serotype 12 F||2.55|0.89|
91627429|NCT03803202|183146128|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 15B||2.57|1.11|
91627430|NCT03803202|183146128|OTHER||Ratio of GMT|3.37|||||TWO_SIDED|95.0|2.18|5.2|||t-test, 2 sided|||Serotype 17F||5.20|2.18|
91627431|NCT03803202|183146128|OTHER||Ratio of GMT|13.7|||||TWO_SIDED|95.0|8.26|22.72|||t-test, 2 sided|||Serotype 20B||22.72|8.26|
91627432|NCT03803202|183146128|OTHER||Ratio of GMT|2.17|||||TWO_SIDED|95.0|1.36|3.46|||t-test, 2 sided|||Serotype 22F||3.46|1.36|
91627433|NCT03803202|183146128|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 33F||2.57|1.11|
91627434|NCT03803202|183146129|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.95|1.93|||t-test, 2 sided|||Serotype 2||1.93|0.95|
91627435|NCT03803202|183146129|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|1.07|2.13|||t-test, 2 sided|||Serotype 8||2.13|1.07|
91627436|NCT03803202|183146129|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|1.09|2.33|||t-test, 2 sided|||Serotype 9N||2.33|1.09|
91627437|NCT03803202|183146129|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.45|3.47|||t-test, 2 sided|||Serotype 10A||3.47|1.45|
91627438|NCT03803202|183146129|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.27|2.65|||t-test, 2 sided|||Serotype 11A||2.65|1.27|
91627439|NCT03803202|183146129|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.77|2.23|||t-test, 2 sided|||Serotype 12F||2.23|0.77|
91627440|NCT03803202|183146129|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.8|1.91|||t-test, 2 sided|||Serotype 15B||1.91|0.80|
91627441|NCT03803202|183146129|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.7|4.07|||t-test, 2 sided|||Serotype 17F||4.07|1.70|
91627442|NCT03803202|183146129|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.61|3.67|||t-test, 2 sided|||Serotype 20B||3.67|1.61|
91627443|NCT03803202|183146129|OTHER||Ratio of GMT|2.49|||||TWO_SIDED|95.0|1.7|3.65|||t-test, 2 sided|||Serotype 22F||3.65|1.70|
91714073|NCT05116202|183319823|SUPERIORITY||Difference in pRR|-32.27|||||TWO_SIDED|95.0|-65.01|0.46||||||||0.46|-65.01|
91714074|NCT05116202|183319823|SUPERIORITY||Difference in pRR|-17.27|||||TWO_SIDED|95.0|-49.75|15.21||||||||15.21|-49.75|
91714075|NCT05116202|183319825|SUPERIORITY||Difference in pRR|-6.82|||||TWO_SIDED|95.0|-31.31|17.68||||||||17.68|-31.31|
91714076|NCT05116202|183319825|SUPERIORITY||Difference in pRR|-31.82|||||TWO_SIDED|95.0|-63.79|0.16||||||||0.16|-63.79|
91714077|NCT05116202|183319825|SUPERIORITY||Difference in pRR|-21.82|||||TWO_SIDED|95.0|-53.44|9.8||||||||9.80|-53.44|
91627444|NCT03803202|183146129|OTHER||Ratio of GMT|1.67|||||TWO_SIDED|95.0|1.1|2.54|||t-test, 2 sided|||Serotype 33F||2.54|1.10|
91627445|NCT03803202|183146129|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.07|||t-test, 2 sided|||Serotype 2||2.07|0.98|
91627446|NCT03803202|183146129|OTHER||Ratio of GMT|1.58|||||TWO_SIDED|95.0|1.11|2.26|||t-test, 2 sided|||Serotype 8||2.26|1.11|
91627447|NCT03803202|183146129|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.23|2.72|||t-test, 2 sided|||Serotype 9N||2.72|1.23|
91627448|NCT03803202|183146129|OTHER||Ratio of GMT|2.59|||||TWO_SIDED|95.0|1.66|4.05||||||Serotype 10A||4.05|1.66|
91627449|NCT03803202|183146129|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.32|2.73|||t-test, 2 sided|||Serotype 11A||2.73|1.32|
91627450|NCT03803202|183146129|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|0.93|2.71|||t-test, 2 sided|||Serotype 12F||2.71|0.93|
91627451|NCT03803202|183146129|OTHER||Ratio of GMT|1.68|||||TWO_SIDED|95.0|1.11|2.53|||t-test, 2 sided|||Serotype 15B||2.53|1.11|
91664107|NCT00205777|183222265|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
91627452|NCT03803202|183146129|OTHER||Ratio of GMT|3.27|||||TWO_SIDED|95.0|2.17|4.93|||t-test, 2 sided|||Serotype 17F||4.93|2.17|
91627453|NCT03803202|183146129|OTHER||Ratio of GMT|2.79|||||TWO_SIDED|95.0|1.85|4.22|||t-test, 2 sided|||Serotype 20B||4.22|1.85|
91627454|NCT03803202|183146129|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.79|3.88|||t-test, 2 sided|||Serotype 22F||3.88|1.79|
91627455|NCT03803202|183146129|OTHER||Ratio of GMT|2.05|||||TWO_SIDED|95.0|1.4|3.01|||t-test, 2 sided|||Serotype 33F||3.01|1.40|
91627456|NCT03803202|183146129|OTHER||Ratio of GMT|1.97|||||TWO_SIDED|95.0|1.37|2.84|||t-test, 2 sided|||Serotype 2||2.84|1.37|
91627457|NCT03803202|183146129|OTHER||Ratio of GMT|2.98|||||TWO_SIDED|95.0|2.12|4.18|||t-test, 2 sided|||Serotype 8||4.18|2.12|
91627458|NCT03803202|183146129|OTHER||Ratio of GMT|2.99|||||TWO_SIDED|95.0|2.02|4.44|||t-test, 2 sided|||Serotype 9N||4.44|2.02|
91627459|NCT03803202|183146129|OTHER||Ratio of GMT|3.63|||||TWO_SIDED|95.0|2.25|5.86|||t-test, 2 sided|||Serotype 10A||5.86|2.25|
91627460|NCT03803202|183146129|OTHER||Ratio of GMT|2.86|||||TWO_SIDED|95.0|1.96|4.18|||t-test, 2 sided|||Serotype 11A||4.18|1.96|
91627461|NCT03803202|183146129|OTHER||Ratio of GMT|1.64|||||TWO_SIDED|95.0|0.91|2.96|||t-test, 2 sided|||Serotype 12F||2.96|0.91|
91627462|NCT03803202|183146129|OTHER||Ratio of GMT|2.93|||||TWO_SIDED|95.0|1.87|4.61|||t-test, 2 sided|||Serotype 15B||4.61|1.87|
91627463|NCT03803202|183146129|OTHER||Ratio of GMT|4.0|||||TWO_SIDED|95.0|2.55|6.26|||t-test, 2 sided|||Serotype 17F||6.26|2.55|
91627464|NCT03803202|183146129|OTHER||Ratio of GMT|3.82|||||TWO_SIDED|95.0|2.46|5.91|||t-test, 2 sided|||Serotype 22F||5.91|2.46|
91627465|NCT03803202|183146129|OTHER||Ratio of GMT|4.02|||||TWO_SIDED|95.0|2.74|5.9|||t-test, 2 sided|||Serotype 22F||5.90|2.74|
91627466|NCT03803202|183146129|OTHER||Ratio of GMT|2.11|||||TWO_SIDED|95.0|1.38|3.23|||t-test, 2 sided|||Serotype 33F||3.23|1.38|
91627467|NCT01125293|183146133|OTHER|||||||0.69|||||||Two stage design, exact method|||In a two-stage Simon design, a VGPR or better rate of at least 18% is considered promising versus a 5% or less rate. In stage 1, if 1 or fewer of 23 evaluable participants achieve VGPR, the regimen is considered non-promising else continue with 24 more patients enrolled. If \</=4 of 47 evaluable patients have VGPR or better, the regimen is considered non-promising. If \>/=5, then the regimen is considered promising for further study. With this design, there is 90% power and 1-sided 10% alpha.|The study did not continue to stage 2 given 1 VGPR or better response was observed in 23 evaluable participants in stage 1.|||0.69
91627468|NCT01270958|183146140|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627469|NCT01270958|183146141|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627470|NCT01270958|183146142|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627471|NCT01270958|183146143|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627472|NCT01270958|183146144|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627473|NCT01270958|183146145|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627474|NCT01270958|183146146|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627475|NCT01270958|183146147|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627476|NCT01270958|183146148|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||<0.01
91627477|NCT01270958|183146149|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627478|NCT01270958|183146150|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627479|NCT01270958|183146151|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627480|NCT01270958|183146152|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627481|NCT01270958|183146153|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627482|NCT01270958|183146154|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627483|NCT01270958|183146155|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91664108|NCT00205777|183222265|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
91664109|NCT00205777|183222265|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
91664110|NCT00205777|183222265|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
91664111|NCT00205777|183222265|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
91664112|NCT00205777|183222266|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
91664113|NCT00205777|183222266|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
91664114|NCT00205777|183222267|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
91664115|NCT00205777|183222267|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
91664116|NCT00205777|183222267|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
91664117|NCT00205777|183222267|SUPERIORITY_OR_OTHER|||||||0.088||95.0|||||ANOVA|||||||0.088
91664118|NCT00205777|183222267|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
91482422|NCT04090957|182838743|SUPERIORITY||Least square mean difference|-15.49||||0.0001|TWO_SIDED|95.0|-24.04|-6.94|||Mixed Model for Repeated Measures|||4\_Week 12; E4 20 mg vs Placebo||-6.94|-24.04|0.0001
91664119|NCT00205777|183222268|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
91664120|NCT00205777|183222268|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
91664121|NCT00205777|183222269|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.90
91664122|NCT00205777|183222269|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|||||||0.74
91664123|NCT00205777|183222269|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
91482423|NCT04090957|182838744|SUPERIORITY||Least square mean difference|-0.04||||0.7786|TWO_SIDED|95.0|-0.2|0.12|||Mixed Model for Repeated Measures|||1\_Week 4; E4 15 mg vs Placebo||0.12|-0.20|0.7786
91482424|NCT04090957|182838744|SUPERIORITY||Least square mean difference|-0.17||||0.031|TWO_SIDED|95.0|-0.33|-0.01|||Mixed Model for Repeated Measures|||2\_Week 4; E4 20 mg vs Placebo||-0.01|-0.33|0.0310
91482425|NCT04090957|182838744|SUPERIORITY||Least square mean difference|-0.04||||0.7941|TWO_SIDED|95.0|-0.21|0.12|||Mixed Model for Repeated Measures|||3\_Week 12; E4 15 mg vs Placebo||0.12|-0.21|0.7941
91482426|NCT04090957|182838744|SUPERIORITY||Least square mean difference|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.51|-0.18|||Mixed Model for Repeated Measures|||4\_Week 12; E4 20 mg vs Placebo||-0.18|-0.51|<.0001
91627484|NCT01270958|183146156|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627485|NCT01270958|183146157|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627486|NCT01270958|183146158|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
91627487|NCT02228564|183146163|NON_INFERIORITY|"The sample size calculation assumes the following:~The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154."|||||<|0.0325|||||||Exact binomial test|||"H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.~H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%."||||<0.0325
91627488|NCT02925312|183146210|SUPERIORITY|||||||0.05|||||||McNemar|||The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.||||0.05
91664124|NCT00205777|183222269|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
91664125|NCT00205777|183222269|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||||||0.24
91664126|NCT00205777|183222270|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
91664127|NCT00205777|183222270|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|||||||0.070
91664128|NCT00205777|183222271|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||ANOVA|||||||0.77
91664129|NCT00205777|183222271|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||||||0.91
91664130|NCT00205777|183222271|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
91664131|NCT00205777|183222271|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
91664132|NCT00205777|183222271|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||||||0.012
91664133|NCT00205777|183222272|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
91664134|NCT00205777|183222272|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
91664135|NCT00205777|183222273|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||||||0.30
91664136|NCT00205777|183222273|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||||||0.62
91664137|NCT00205777|183222273|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
91664138|NCT00205777|183222273|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||0.041
91664139|NCT00205777|183222273|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
91664140|NCT00205777|183222274|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANOVA|||||||0.70
91664141|NCT00205777|183222274|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
91664142|NCT00205777|183222275|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
91664143|NCT00205777|183222275|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
91664144|NCT00205777|183222275|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
91664145|NCT00205777|183222275|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||||||0.89
91664146|NCT00205777|183222275|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
91664147|NCT00205777|183222276|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
91664148|NCT00205777|183222276|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
91664149|NCT00205777|183222277|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
91664150|NCT00205777|183222277|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
91664151|NCT00205777|183222277|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.050
91664152|NCT00205777|183222277|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||ANOVA|||||||0.061
91664153|NCT00205777|183222277|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
91664154|NCT00205777|183222278|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|||||||0.15
91664155|NCT00205777|183222278|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANOVA|||||||0.056
91664156|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.20
91664157|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.12
91664158|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.17
91664159|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.92
91482427|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9666|TWO_SIDED|95.0|-8.0|7.7|||Chi-squared|||1\_Week 1, ≥50% reduction, E4 15 mg vs placebo||7.7|-8.0|0.9666
91627489|NCT00971633|183146222|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.904|||||TWO_SIDED|95.0|0.796|1.028|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.028|0.796|
91627490|NCT00971633|183146222|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.991|||||TWO_SIDED|95.0|0.873|1.126|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.126|0.873|
91627491|NCT00971633|183146223|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K.) ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.886|||||TWO_SIDED|95.0|0.813|0.966|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||0.966|0.813|
91627492|NCT00971633|183146223|NON_INFERIORITY_OR_EQUIVALENCE|§ Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.951|||||TWO_SIDED|95.0|0.872|1.037|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally. Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.037|0.872|
91627493|NCT03136367|183146319|SUPERIORITY|||||||0.045||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.045
91627494|NCT03136367|183146319|SUPERIORITY|||||||0.2||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.20
91627495|NCT03136367|183146319|SUPERIORITY|||||||0.82||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.82
91627496|NCT03136367|183146320|SUPERIORITY|||||||0.048||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.048
91627497|NCT03136367|183146320|SUPERIORITY|||||||0.015||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.015
91627498|NCT03136367|183146320|SUPERIORITY|||||||0.43||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.43
91627499|NCT03136367|183146321|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.46
91627500|NCT03136367|183146321|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.34
91627501|NCT03136367|183146321|SUPERIORITY|||||||0.165|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.165
91627502|NCT03136367|183146323|SUPERIORITY|||||||0.25||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.25
91627503|NCT03136367|183146323|SUPERIORITY|||||||0.89||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.89
91627504|NCT03136367|183146323|SUPERIORITY|||||||0.54||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.54
91627505|NCT03136367|183146324|SUPERIORITY|||||||0.72||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.72
91627506|NCT03136367|183146324|SUPERIORITY|||||||0.41||||||Adjusted for repeated within-patient measurements.|McNemar|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.41
91627507|NCT03136367|183146324|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
91627508|NCT03136367|183146325|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.01
91627509|NCT03136367|183146325|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.12
91627510|NCT03136367|183146325|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.78
91627511|NCT03136367|183146326|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
91627512|NCT03136367|183146326|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
91627513|NCT03136367|183146327|SUPERIORITY|||||||0.06||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.06
91627514|NCT03136367|183146327|SUPERIORITY|||||||0.65||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.65
91627515|NCT03136367|183146327|SUPERIORITY|||||||0.36||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.36
91627516|NCT03136367|183146328|SUPERIORITY|||||||0.11||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.11
91627517|NCT03136367|183146328|SUPERIORITY|||||||0.037||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.037
91627518|NCT03136367|183146328|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
91627519|NCT00523614|183146334|NON_INFERIORITY_OR_EQUIVALENCE|"Size of the study adapted to the use of DNG/EE in female fertile age. Market share of DNG/EE of 13% in Germany. Assuming that 30% of women in the fertile age range were current users of OCs, a prevalence of current use of DNG/EE of about 4% was estimated.~Based on these data the number of cases needed to exclude a twofold increased VTE risk was estimated at about 500-700 cases (based on four controls per case)."|Odds Ratio (OR)|0.89|||<|0.05||95.0|0.57|1.39|||Regression, Logistic|||Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)||1.39|0.57|<0.05
91627520|NCT04038385|183146343|SUPERIORITY||Mean Difference (Net)|-42.87||||0.001|TWO_SIDED|95.0|-65.25|-20.49|||Mixed Models Analysis|||||-20.49|-65.25|0.001
91627521|NCT04038385|183146344|SUPERIORITY||Median Difference (Net)|23.91||||0.031|TWO_SIDED|95.0|2.21|45.62|||Mixed Models Analysis|||||45.62|2.21|0.031
91627522|NCT04038385|183146345|SUPERIORITY||Median Difference (Net)|-0.06||||0.662|TWO_SIDED|95.0|-0.33|0.21|||Mixed Models Analysis|||||0.21|-0.33|0.662
91627523|NCT04038385|183146346|SUPERIORITY||Mean Difference (Net)|0.28||||0.047|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||||0.55|0.00|0.047
91627524|NCT04038385|183146347|SUPERIORITY||Odds Ratio (OR)|17.39|||<|0.01|TWO_SIDED|95.0|8.64|35.02|||Regression, Logistic|||||35.02|8.64|<0.01
91627525|NCT04038385|183146348|SUPERIORITY||Odds Ratio (OR)|3.9||||0.056|TWO_SIDED|95.0|1.0|16.1|||Mixed Models Analysis|||||16.1|1.0|0.056
91627526|NCT04038385|183146349|SUPERIORITY||Odds Ratio (OR)|4.0||||0.05|TWO_SIDED|95.0|1.0|16.3|||Mixed Models Analysis|||||16.3|1.0|0.050
91627527|NCT04038385|183146350|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||||-1.0|-2.5|0.001
91664160|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.86
91627528|NCT04038385|183146351|SUPERIORITY||Median Difference (Net)|-0.7||||0.082|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|||||0.1|-1.4|0.082
91627529|NCT04038385|183146352|SUPERIORITY||Mean Difference (Net)|-1.5||||0.001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis|||||-0.8|-2.2|0.001
91627530|NCT04038385|183146353|SUPERIORITY||Median Difference (Net)|-0.7||||0.039|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||||-0.0|-1.4|0.039
91627531|NCT04038385|183146354|SUPERIORITY||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.962
91627532|NCT04038385|183146355|SUPERIORITY||Mean Difference (Net)|-0.2||||0.277|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|.277
91627533|NCT04038385|183146356|SUPERIORITY||Median Difference (Net)|-0.4||||0.155|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.155
91627534|NCT04038385|183146357|SUPERIORITY||Mean Difference (Net)|0.1||||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.740
91627535|NCT04038385|183146358|SUPERIORITY||Median Difference (Net)|-0.2||||0.122|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.122
91627536|NCT04038385|183146359|SUPERIORITY||Mean Difference (Net)|-0.2||||0.177|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.177
91627537|NCT04038385|183146360|SUPERIORITY||Median Difference (Net)|0.1||||0.514|TWO_SIDED|95.0|-0.3|0.5|||Mixed Models Analysis|||||0.5|-0.3|0.514
91627538|NCT04038385|183146361|SUPERIORITY||Median Difference (Net)|0.2||||0.335|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.335
91664161|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.18
91664162|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.12
91664163|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.096
91627539|NCT04038385|183146362|SUPERIORITY||Mean Difference (Net)|0.1||||0.75|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||||0.6|-0.4|0.750
91627540|NCT04038385|183146363|SUPERIORITY||Mean Difference (Net)|-0.2||||0.455|TWO_SIDED|95.0|-0.7|0.3|||Mixed Models Analysis|||||0.3|-0.7|0.455
91664164|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.76
91664165|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.93
91664166|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.36
91664167|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.34
91664168|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.98
91664169|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
91664170|NCT00205777|183222280|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
91664171|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.080
91482428|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|3.6||||0.3759|TWO_SIDED|95.0|-4.4|11.7|||Chi-squared|||2\_Week 1, ≥50% reduction, E4 20 mg vs placebo||11.7|-4.4|0.3759
91627541|NCT04038385|183146364|SUPERIORITY||Mean Difference (Net)|0.9||||0.053|TWO_SIDED|95.0|0.0|1.8|||Mixed Models Analysis|||||1.8|-0.0|0.053
91627542|NCT04038385|183146365|SUPERIORITY||Mean Difference (Net)|0.0||||0.986|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis|||||0.9|-0.9|.986
91627543|NCT04038385|183146366|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.6|2.2|||Mixed Models Analysis|||||2.2|0.6|0.810
91627544|NCT04038385|183146367|SUPERIORITY||Odds Ratio (OR)|0.8||||0.591|TWO_SIDED|95.0|0.4|1.7|||Mixed Models Analysis|||||1.7|0.4|0.591
91627545|NCT02279160|183146381|SUPERIORITY||Multiple imputation|0.742||||0.022|TWO_SIDED|95.0|0.575|0.958|||ANCOVA|||||0.958|0.575|0.0220
91627546|NCT02279160|183146382|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9002|TWO_SIDED|95.0|-28.0|30.0|||Stratified Wilcoxon|||||30.0|-28.0|0.9002
91627547|NCT03180294|183146401|SUPERIORITY|||||||0.46|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.46
91627548|NCT03180294|183146401|SUPERIORITY|||||||0.54|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.54
91627549|NCT03180294|183146402|SUPERIORITY|||||||0.95||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.95
91664172|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.41
91664173|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.65
91664174|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.18
91664175|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.36
91664176|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.27
91664177|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.25
91664178|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.053
91664179|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.40
91664180|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.45
91664181|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.012
91664182|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.54
91664183|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.11
91664184|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.35
91664185|NCT00205777|183222282|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.34
91664186|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.21
91664187|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.058
91664188|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.76
91664189|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.34
91664190|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.51
91664191|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.14
91664192|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.57
91664193|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
91714078|NCT05116202|183319826|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.42|10.42||||||||10.42|0.42|
91627550|NCT03180294|183146402|SUPERIORITY|||||||0.73||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.73
91627551|NCT03180294|183146402|SUPERIORITY|||||||0.46||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.46
91627552|NCT03180294|183146402|SUPERIORITY|||||||0.42||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.42
91627553|NCT03180294|183146403|SUPERIORITY|||||||0.24||||||One-side significance level 0.05|t-test, 1 sided|||||||0.24
91627554|NCT03180294|183146403|SUPERIORITY|||||||0.74||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.74
91627555|NCT03180294|183146404|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
91627556|NCT03180294|183146404|SUPERIORITY|||||||0.6||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.60
91627557|NCT03180294|183146404|SUPERIORITY|||||||0.9||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.90
91664194|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.24
91482429|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|0.9||||0.7164|TWO_SIDED|95.0|-3.9|5.6|||Chi-squared|||3\_Week 1, ≥75% reduction, E4 15 mg vs placebo||5.6|-3.9|0.7164
91627558|NCT03180294|183146404|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
91627559|NCT03180294|183146405|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
91627560|NCT03180294|183146405|SUPERIORITY|||||||0.35||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.35
91627561|NCT03180294|183146405|SUPERIORITY|||||||0.83||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.83
91627562|NCT03180294|183146405|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
91627563|NCT03180294|183146406|SUPERIORITY|||||||0.78||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.78
91627564|NCT03180294|183146406|SUPERIORITY|||||||0.51||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.51
91627565|NCT03180294|183146406|SUPERIORITY|||||||0.49||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.49
91627566|NCT03180294|183146406|SUPERIORITY|||||||0.5||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.50
91627567|NCT03180294|183146407|SUPERIORITY|||||||0.71|||||||Chi-squared|One-sided significance level 0.05||||||0.71
91627568|NCT03180294|183146407|SUPERIORITY|||||||0.34|||||||Chi-squared|One-sided significance level 0.05||||||0.34
91627569|NCT03180294|183146408|SUPERIORITY|||||||0.23||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.23
91627570|NCT03180294|183146408|SUPERIORITY|||||||0.25||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.25
91627571|NCT01951326|183146430|SUPERIORITY|||||||0.0048|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0048
91627572|NCT01951326|183146431|SUPERIORITY|||||||0.0116|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0116
91627573|NCT01951326|183146432|SUPERIORITY|||||||0.0616|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0616
91627574|NCT01951326|183146433|SUPERIORITY|||||||0.0851|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0851
91627575|NCT01951326|183146434|SUPERIORITY|||||||0.0147|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0147
91627576|NCT01951326|183146435|SUPERIORITY|||||||0.151|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.1510
91627577|NCT01951326|183146436|SUPERIORITY|||||||0.2402|||||||Log Rank|||||||0.2402
91627578|NCT01951326|183146437|SUPERIORITY|||||||0.046|||||||Log Rank|||||||0.0460
91627579|NCT01951326|183146438|SUPERIORITY|||||||0.0031|||||||Log Rank|||||||0.0031
91627580|NCT01951326|183146439|SUPERIORITY|||||||0.01|||||||Log Rank|||||||0.0100
91627581|NCT01951326|183146440|SUPERIORITY|||||||0.0077|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0077
91627582|NCT01951326|183146441|SUPERIORITY|||||||0.0422|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0422
91627583|NCT00762528|183146552|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627584|NCT00762528|183146553|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627585|NCT00762528|183146554|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627586|NCT00762528|183146555|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627587|NCT00762528|183146556|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627588|NCT00762528|183146557|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627589|NCT00762528|183146558|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627590|NCT00762528|183146559|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91627591|NCT03417505|183146560|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|Paired t-test comparison||||||<0.01
91627592|NCT03417505|183146561|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparisons, one-sided||||||<0.05
91627593|NCT03417505|183146562|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|paired 1-sided t-test||||||<0.01
91627594|NCT03417505|183146563|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparison, one sided p value||||||<0.01
91627595|NCT03417505|183146564|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|t-test, 1 sided|paired||||||>0.05
91627596|NCT03417505|183146565|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
91664195|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
91664196|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.62
91627597|NCT03417505|183146566|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.01
91627598|NCT03417505|183146567|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
91627599|NCT03417505|183146568|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||>0.05
91627600|NCT04211961|183146589|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91627601|NCT04211961|183146590|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
91627602|NCT04211961|183146591|SUPERIORITY|||||||0.3|||||||Fisher Exact|||||||0.3
91627603|NCT04211961|183146592|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
91627604|NCT04211961|183146594|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
91627605|NCT04211961|183146595|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91627606|NCT04211961|183146596|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91664197|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.72
91627607|NCT04211961|183146598|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
91627608|NCT04211961|183146599|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
91482430|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|-0.6||||0.7859|TWO_SIDED|95.0|-4.9|3.7|||Chi-squared|||4\_Week 1, ≥75% reduction, E4 20 mg vs placebo||3.7|-4.9|0.7859
91482431|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|2.1||||0.6744|TWO_SIDED|95.0|-7.5|11.6|||Chi-squared|||5\_Week 2, ≥50% reduction, E4 15 mg vs placebo||11.6|-7.5|0.6744
91482432|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|2.6||||0.5931|TWO_SIDED|95.0|-6.9|12.0|||Chi-squared|||6\_Week 2, ≥50% reduction, E4 20 mg vs placebo||12.0|-6.9|0.5931
91627609|NCT04211961|183146600|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
91664198|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.16
91664199|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.059
91664200|NCT00205777|183222284|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.30
91714079|NCT05116202|183319826|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|0.79|19.7||||||||19.70|0.79|
91482433|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|-0.2||||0.964|TWO_SIDED|95.0|-7.5|7.1|||Chi-squared|||7\_Week 2, ≥75% reduction, E4 15 mg vs placebo||7.1|-7.5|0.9640
91482434|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|-1.2||||0.7449|TWO_SIDED|95.0|-8.2|5.9|||Chi-squared|||8\_Week 2, ≥75% reduction, E4 20 mg vs placebo||5.9|-8.2|0.7449
91482435|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|5.1||||0.3271|TWO_SIDED|95.0|-5.1|15.4|||Chi-squared|||9\_Week 3, ≥50% reduction, E4 15 mg vs placebo||15.4|-5.1|0.3271
91482436|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|6.9||||0.1842|TWO_SIDED|95.0|-3.2|17.0|||Chi-squared|||10\_Week 3, ≥50% reduction, E4 20 mg vs placebo||17.0|-3.2|0.1842
91482437|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|-1.2||||0.7716|TWO_SIDED|95.0|-9.4|6.9|||Chi-squared|||11\_Week 3, ≥75% reduction, E4 15 mg vs placebo||6.9|-9.4|0.7716
91482438|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|4.6||||0.2934|TWO_SIDED|95.0|-3.9|13.0|||Chi-squared|||12\_Week 3, ≥75% reduction, E4 20 mg vs placebo||13.0|-3.9|0.2934
91482439|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|7.3||||0.1701|TWO_SIDED|95.0|-3.1|17.8|||Chi-squared|||13\_Week 4, ≥50% reduction, E4 15 mg vs placebo||17.8|-3.1|0.1701
91482440|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|9.5||||0.0723|TWO_SIDED|95.0|-0.8|19.8|||Chi-squared|||14\_Week 4, ≥50% reduction, E4 20 mg vs placebo||19.8|-0.8|0.0723
91482441|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|6.7||||0.1258|TWO_SIDED|95.0|-1.9|15.2|||Chi-squared|||15\_Week 4, ≥75% reduction, E4 15 mg vs placebo||15.2|-1.9|0.1258
91482442|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|11.2||||0.0126|TWO_SIDED|95.0|2.5|19.9|||Chi-squared|||16\_Week 4, ≥75% reduction, E4 20 mg vs placebo||19.9|2.5|0.0126
91482443|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|10.9||||0.0436|TWO_SIDED|95.0|0.4|21.5|||Chi-squared|||17\_Week 5, ≥50% reduction, E4 15 mg vs placebo||21.5|0.4|0.0436
91482444|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|17.5||||0.001|TWO_SIDED|95.0|7.3|27.8|||Chi-squared|||18\_Week 5, ≥50% reduction, E4 20 mg vs placebo||27.8|7.3|0.0010
91482445|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|6.6||||0.1623|TWO_SIDED|95.0|-2.7|15.9|||Chi-squared|||19\_Week 5, ≥75% reduction, E4 15 mg vs placebo||15.9|-2.7|0.1623
91482446|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|16.5||||0.0009|TWO_SIDED|95.0|7.0|26.1|||Chi-squared|||20\_Week 5, ≥75% reduction, E4 20 mg vs placebo||26.1|7.0|0.0009
91482447|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|9.9||||0.0677|TWO_SIDED|95.0|-0.7|20.4|||Chi-squared|||21\_Week 6, ≥50% reduction, E4 15 mg vs placebo||20.4|-0.7|0.0677
91482448|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|18.5||||0.0005|TWO_SIDED|95.0|8.2|28.7|||Chi-squared|||22\_Week 6, ≥50% reduction, E4 20 mg vs placebo||28.7|8.2|0.0005
91482449|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|-1.0||||0.8432|TWO_SIDED|95.0|-11.0|9.0|||Chi-squared|||23\_Week 6, ≥75% reduction, E4 15 mg vs placebo||9.0|-11.0|0.8432
91482450|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|14.3||||0.0073|TWO_SIDED|95.0|4.0|24.6|||Chi-squared|||24\_Week 6, ≥75% reduction, E4 20 mg vs placebo||24.6|4.0|0.0073
91482451|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|7.1||||0.1894|TWO_SIDED|95.0|-3.5|17.7|||Chi-squared|||25\_Week 7, ≥50% reduction, E4 15 mg vs placebo||17.7|-3.5|0.1894
91482452|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|15.8||||0.0028|TWO_SIDED|95.0|5.6|26.1|||Chi-squared|||26\_Week 7, ≥50% reduction, E4 20 mg vs placebo||26.1|5.6|0.0028
91482453|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|3.6||||0.4844|TWO_SIDED|95.0|-6.5|13.8|||Chi-squared|||27\_Week 7, ≥75% reduction, E4 15 mg vs placebo||13.8|-6.5|0.4844
91482454|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|18.0||||0.0009|TWO_SIDED|95.0|7.6|28.4|||Chi-squared|||28\_Week 7, ≥75% reduction, E4 20 mg vs placebo||28.4|7.6|0.0009
91482455|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|8.3||||0.122|TWO_SIDED|95.0|-2.2|18.9|||Chi-squared|||29\_Week 8, ≥50% reduction, E4 15 mg vs placebo||18.9|-2.2|0.1220
91627610|NCT04211961|183146601|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
91627611|NCT04211961|183146602|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
91627612|NCT04362813|183146704|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2874|TWO_SIDED|95.0|0.76|2.54|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5).||2.54|0.76|0.2874
91627613|NCT04362813|183146705|SUPERIORITY||Odds Ratio (OR)|0.67||||0.3303|TWO_SIDED|95.0|0.3|1.5|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5)||1.50|0.30|0.3303
91627614|NCT04445688|183146737|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.2|-4.4|||ANOVA|||||-4.4|-10.2|<0.0001
91627615|NCT04445688|183146738|SUPERIORITY||difference in Least Squares Mean|-21.8|||<|0.0001|TWO_SIDED|95.0|-29.5|-14.1|||ANOVA|||||-14.1|-29.5|<0.0001
91627616|NCT04445688|183146739|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.2|||ANOVA|||||-4.2|-10.5|<0.0001
91627617|NCT00918346|183146751|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type 1 error rate of 5%.|Mean Difference (Final Values)|0.01||||0.96||95.0|-0.46|0.49|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4.|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.49|-0.46|0.96
91627618|NCT00918346|183146752|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type I error rate of 5%.|Median Difference (Final Values)|-0.05||||0.83||95.0|-0.52|0.42|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.42|-0.52|0.83
91627619|NCT01963780|183146753|SUPERIORITY|Performance goal is 65%.|Proportion|0.544||||0.9663|TWO_SIDED|95.0|0.428|0.657|||one-sided exact binomial test|||||0.657|0.428|0.9663
91627620|NCT01963780|183146754|OTHER|No statistical hypothesis testing|Proportion|0.167|||||TWO_SIDED|95.0|0.092|0.268||||||||0.268|0.092|
91627621|NCT01963780|183146755|OTHER|No statistical hypothesis testing|Proportion|0.064|||||TWO_SIDED|95.0|0.021|0.143||||||||0.143|0.021|
91627622|NCT01963780|183146756|OTHER|No statistical hypothesis testing|Mean|0.3|||||TWO_SIDED|95.0|0.1|0.4||||||||0.4|0.1|
91627623|NCT03549429|183146765|SUPERIORITY||Percent difference|8.0||||0.03|TWO_SIDED|95.0|1.5|14.4|||McNemar|||We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.||14.4|1.5|0.03
91627624|NCT03549429|183146766|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.23|TWO_SIDED||||||t-test, 2 sided|paired||||||0.23
91627625|NCT02157168|183146768|SUPERIORITY|||||||0.624||||||This comparison reflects intent to treat and is the main comparison in the study.|Chi-squared|||CG and IG (IG1+IG2)||||0.624
91627626|NCT02157168|183146768|SUPERIORITY|||||||0.001||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.001
91627627|NCT02157168|183146769|SUPERIORITY|||||||0.278||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.278
91627628|NCT02157168|183146769|SUPERIORITY|||||||0.056||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.056
91627629|NCT02157168|183146770|SUPERIORITY|||||||0.889||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.889
91627630|NCT02157168|183146770|SUPERIORITY|||||||0.691||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.691
91627631|NCT02157168|183146771|SUPERIORITY|||||||0.741||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.741
91627632|NCT02157168|183146771|SUPERIORITY|||||||0.966||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.966
91627633|NCT02157168|183146772|SUPERIORITY|||||||0.117||||||This comparison captures the change over the intervention period.|Chi-squared|||||||.117
91627634|NCT02157168|183146772|SUPERIORITY|||||||0.638||||||This comparison is an indication of whether the change seen between baseline and 6 months in the IG1 was due to the intervention or simply due to 6 months' enrollment.|Chi-squared|||||||.638
91627635|NCT02971293|183146773|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627636|NCT02971293|183146773|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627637|NCT02971293|183146773|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
91627638|NCT02971293|183146785|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.002
91627639|NCT02971293|183146785|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91664201|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.72
91482456|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|14.7||||0.0058|TWO_SIDED|95.0|4.4|25.0|||Chi-squared|||30\_Week 8, ≥50% reduction, E4 20 mg vs placebo||25.0|4.4|0.0058
91627640|NCT02971293|183146785|SUPERIORITY|||||||0.011|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.011
91627641|NCT02971293|183146786|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627642|NCT02971293|183146786|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627643|NCT02971293|183146786|SUPERIORITY|||||||0.201|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.201
91627644|NCT02971293|183146787|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627645|NCT02971293|183146787|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627646|NCT02971293|183146787|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
91627647|NCT02971293|183146788|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627648|NCT02971293|183146788|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627649|NCT02971293|183146788|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
91627650|NCT02971293|183146789|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627651|NCT02971293|183146789|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627652|NCT02971293|183146789|SUPERIORITY|||||||0.092|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.092
91627653|NCT02971293|183146790|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627654|NCT02971293|183146790|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627655|NCT02971293|183146790|SUPERIORITY|||||||0.279|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.279
91627656|NCT02971293|183146791|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
91627657|NCT02971293|183146791|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627658|NCT02971293|183146791|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
91664202|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.98
91482457|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|4.2||||0.4151|TWO_SIDED|95.0|-5.9|14.4|||Chi-squared|||31\_Week 8, ≥75% reduction, E4 15 mg vs placebo||14.4|-5.9|0.4151
91627659|NCT02971293|183146792|SUPERIORITY|||||||0.205|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.205
91627660|NCT02971293|183146792|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.002
91627661|NCT02971293|183146792|SUPERIORITY|||||||0.06|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.060
91627662|NCT02971293|183146793|SUPERIORITY|||||||0.111|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.111
91627663|NCT02971293|183146793|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627664|NCT02971293|183146793|SUPERIORITY|||||||0.015|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.015
91664203|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.84
91664204|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.88
91664205|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.86
91792068|NCT02757950|183461855|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.428||||0.0155|TWO_SIDED|95.0|0.215|0.851||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.851|0.215|0.0155
91627665|NCT02971293|183146794|SUPERIORITY|||||||0.621|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.621
91627666|NCT02971293|183146794|SUPERIORITY|||||||0.138|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.138
91627667|NCT02971293|183146794|SUPERIORITY|||||||0.333|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.333
91627668|NCT02971293|183146795|SUPERIORITY|||||||0.748|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.748
91482458|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|20.7||||0.0001|TWO_SIDED|95.0|10.3|31.2|||Chi-squared|||32\_Week 8, ≥75% reduction, E4 20 mg vs placebo||31.2|10.3|0.0001
91627669|NCT02971293|183146795|SUPERIORITY|||||||0.005|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.005
91664206|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.82
91664207|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.11
91664208|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.14
91664209|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.22
91664210|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.88
91664211|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.96
91664212|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.76
91664213|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.92
91664214|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.89
91664215|NCT00205777|183222286|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.83
91664216|NCT04428307|183222287|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.61|2.02||||||||2.02|0.61|
91664217|NCT04428307|183222287|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.49|1.71||||||||1.71|0.49|
91664218|NCT04428307|183222288|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.83|1.8||||||||1.80|0.83|
91664219|NCT04428307|183222288|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.81|1.62||||||||1.62|0.81|
91664220|NCT04428307|183222289|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.8|1.09||||||||1.09|0.80|
91664221|NCT04428307|183222289|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||||1.16|0.85|
91664222|NCT04428307|183222290|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.75|1.73||||||||1.73|0.75|
91664223|NCT04428307|183222290|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.77|1.74||||||||1.74|0.77|
91664224|NCT04428307|183222291|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
91664225|NCT04428307|183222291|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||||1.04|0.89|
91664226|NCT04667338|183222311|SUPERIORITY||||||=|0.5061|||||||Chi-squared|||Pharmacological||||=0.5061
91664227|NCT04667338|183222311|SUPERIORITY||||||=|0.2053|||||||Chi-squared|||Non-pharmacological||||=0.2053
91664228|NCT04667338|183222312|SUPERIORITY||||||=|0.4016|||||||Chi-squared|||||||=0.4016
91664229|NCT04667338|183222315|SUPERIORITY||||||=|0.5274|||||||Chi-squared|||Educational level ongoing or completed level of education||||=0.5274
91664230|NCT04667338|183222315|SUPERIORITY||||||=|0.7051|||||||Chi-squared|||Occupational status and occupation||||=0.7051
91664231|NCT04667338|183222315|SUPERIORITY||||||=|0.3543|||||||Chi-squared|||Civil status||||=0.3543
91664232|NCT04667338|183222315|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Living conditions||||=0.0368
91664233|NCT04667338|183222315|SUPERIORITY||||||=|0.3512|||||||Chi-squared|||Smoking status||||=0.3512
91664234|NCT04667338|183222315|SUPERIORITY||||||=|0.104|||||||Chi-squared|||Alcohol intake||||=0.1040
91664235|NCT04667338|183222315|SUPERIORITY||||||=|0.0202|||||||Chi-squared|||Exercise status||||=0.0202
91664236|NCT04667338|183222315|SUPERIORITY||||||=|0.3503|||||||Chi-squared|||Family history of narcolepsy||||=0.3503
91664237|NCT04667338|183222320|SUPERIORITY||||||=|0.0715|||||||Chi-squared|||General practitioner||||=0.0715
91664238|NCT04667338|183222320|SUPERIORITY||||||=|0.0929|||||||Chi-squared|||Neurologist||||=0.0929
91664239|NCT04667338|183222320|SUPERIORITY||||||=|0.3092|||||||Chi-squared|||Neuropediatrician||||=0.3092
91627670|NCT02971293|183146795|SUPERIORITY|||||||0.013|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.013
91627671|NCT02971293|183146796|SUPERIORITY|||||||0.064|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.064
91627672|NCT02971293|183146796|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627673|NCT02971293|183146796|SUPERIORITY|||||||0.03|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.030
91627674|NCT02971293|183146797|SUPERIORITY|||||||0.018|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.018
91627675|NCT02971293|183146797|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
91627676|NCT02971293|183146797|SUPERIORITY|||||||0.047|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.047
91627677|NCT02971293|183146798|SUPERIORITY|||||||0.477|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.477
91664240|NCT04667338|183222320|SUPERIORITY||||||=|0.4528|||||||Chi-squared|||Neurophysiologist||||=0.4528
91525353|NCT00152009|182925989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1426||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1426
91664241|NCT04667338|183222320|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Pneumologist||||<0.0001
91627678|NCT02971293|183146798|SUPERIORITY|||||||0.014|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.014
91627679|NCT02971293|183146798|SUPERIORITY|||||||0.084|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.084
91627680|NCT02971293|183146799|SUPERIORITY|||||||0.213|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.213
91627681|NCT02971293|183146799|SUPERIORITY|||||||0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.001
91627682|NCT02971293|183146799|SUPERIORITY|||||||0.046|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.046
91627683|NCT02754661|183146804|NON_INFERIORITY|The non-inferiority margin (δ) is pre-defined to be 5% in this study. Posterior Probability was based on Bayesian analysis.|Posterior Probability Bayesian analysis|0.9999|||||TWO_SIDED||||||||Support the claim of statistical non-inferiority of CCE vs CTC|||||
91627684|NCT02754661|183146805|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.3732|||<|0.0001|TWO_SIDED|90.0|0.203|0.5434|||Farrington-Manning test||Based on Farrington-Manning Method|||0.5434|0.2030|<0.0001
91627685|NCT02754661|183146806|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|-0.026||||0.019|TWO_SIDED|90.0|-0.0847|0.0327|||Farrington-Manning test||Based on Farrington-Manning Method|||0.0327|-0.0847|0.0190
91627686|NCT02754661|183146807|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0023||||0.093|TWO_SIDED|90.0|-0.1249|0.1249|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1249|-0.1249|0.0930
91627687|NCT02754661|183146808|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0607||||0.0034|TWO_SIDED|90.0|-0.0371|0.1585|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1585|-0.0371|0.0034
91627688|NCT00729326|183146809|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.|ANCOVA|Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.||Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.||||<.001
91627689|NCT00729326|183146810|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627690|NCT00729326|183146811|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||ANCOVA|||||||.766
91627691|NCT00729326|183146812|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627692|NCT00729326|183146813|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627693|NCT00729326|183146814|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||.117
91627694|NCT00729326|183146815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91664242|NCT04667338|183222320|SUPERIORITY||||||=|0.1785|||||||Chi-squared|||Somnologist||||=0.1785
91664243|NCT04667338|183222320|SUPERIORITY||||||=|0.1474|||||||Chi-squared|||Somnologist-unit||||=0.1474
91664244|NCT04667338|183222321|SUPERIORITY||||||=|0.2042|||||||Chi-squared|||Clinical history||||=0.2042
91664245|NCT04667338|183222321|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Clinical assessment: ESS||||=0.5818
91664246|NCT04667338|183222321|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Neurological assessment||||=0.0368
91664247|NCT04667338|183222321|SUPERIORITY||||||=|0.1128|||||||Chi-squared|||MSLT||||=0.1128
91664248|NCT04667338|183222321|SUPERIORITY||||||=|0.3396|||||||Chi-squared|||AHI||||=0.3396
91664249|NCT04667338|183222321|SUPERIORITY||||||=|0.6794|||||||Chi-squared|||Other procedures||||=0.6794
91664250|NCT04667338|183222321|SUPERIORITY||||||=|0.0138|||||||Chi-squared|||HLA typing||||=0.0138
91664251|NCT04667338|183222321|SUPERIORITY||||||=|0.0597|||||||Chi-squared|||Hypocretin-1 CSF or Orexin||||=0.0597
91664252|NCT04667338|183222322|SUPERIORITY||||||=|0.1171|||||||t-test, 2 sided|||||||=0.1171
91664253|NCT04667338|183222323|SUPERIORITY||||||=|0.3834|||||||t-test, 2 sided|||||||=0.3834
91664254|NCT04667338|183222328|SUPERIORITY||||||=|0.0531|||||||t-test, 2 sided|||||||=0.0531
91664255|NCT04667338|183222329|SUPERIORITY||||||=|0.0005|||||||Chi-squared|||Take short naps||||=0.0005
91664256|NCT04667338|183222329|SUPERIORITY||||||=|0.8221|||||||Chi-squared|||Maintain a regular sleep schedule||||=0.8221
91664257|NCT04667338|183222329|SUPERIORITY||||||=|0.2291|||||||Chi-squared|||Avoid caffeine or alcohol before bedtime||||=0.2291
91664258|NCT04667338|183222329|SUPERIORITY||||||=|0.9177|||||||Chi-squared|||Avoid smoking, especially at night||||=0.9177
91664259|NCT04667338|183222329|SUPERIORITY||||||=|0.4188|||||||Chi-squared|||Exercise daily||||=0.4188
91482459|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|16.7||||0.0015|TWO_SIDED|95.0|6.6|26.9|||Chi-squared|||33\_Week 9, ≥50% reduction, E4 15 mg vs placebo||26.9|6.6|0.0015
91664260|NCT04667338|183222329|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Avoid large, heavy meals right before bedtime||||=0.5818
91482460|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|15.3||||0.0036|TWO_SIDED|95.0|5.1|25.5|||Chi-squared|||34\_Week 9, ≥50% reduction, E4 20 mg vs placebo||25.5|5.1|0.0036
91482461|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|5.3||||0.333|TWO_SIDED|95.0|-5.4|15.9|||Chi-squared|||35\_Week 9, ≥75% reduction, E4 15 mg vs placebo||15.9|-5.4|0.3330
91482462|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|16.9||||0.0023|TWO_SIDED|95.0|6.2|27.5|||Chi-squared|||36\_Week 9, ≥75% reduction, E4 20 mg vs placebo||27.5|6.2|0.0023
91525354|NCT00152009|182925989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.0191
91525355|NCT00098254|182926038|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||Kaplan-Meier|||||||0.0027
91627695|NCT00729326|183146816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627696|NCT00729326|183146817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627697|NCT00729326|183146818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627698|NCT00729326|183146819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627699|NCT00729326|183146820|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627700|NCT00729326|183146821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91627701|NCT01000025|183146832|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.506|TWO_SIDED|95.0|0.83|1.21||Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.|Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.||1.21|0.83|0.506
91627702|NCT01000025|183146833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.61|1.03||1-sided p-value|Log Rank|Stratified by stratification factors at randomization except study center.||||1.03|0.61|0.043
91627703|NCT01000025|183146834|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.67|1.44||1-sided pvalue|Log Rank|||||1.44|0.67|0.46
91627704|NCT01000025|183146835|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.55|0.79|||Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||||0.79|0.55|< 0.0001
91627705|NCT01000025|183146836|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.11||||0.001|TWO_SIDED|95.0|1.84|20.3|||Cochran-Mantel-Haenszel|||||20.3|1.84|0.001
91627706|NCT04423757|183146838|OTHER||Adjusted mean difference|3.38|STANDARD_ERROR_OF_MEAN|3.1||0.2796|TWO_SIDED|90.0|-1.81|8.56|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.56|-1.81|0.2796
91627707|NCT04423757|183146839|OTHER||Odds Ratio (OR)|0.276||||0.0468|TWO_SIDED|90.0|0.091|0.781|||Regression, Logistic||For the calculation of the odds ratio Placebo is taken as reference.|Logistic regression includes treatment as covariate.||0.781|0.091|0.0468
91627708|NCT04423757|183146840|OTHER||Adjusted mean difference|1.35|STANDARD_ERROR_OF_MEAN|3.5||0.698|TWO_SIDED|90.0|-4.47|7.17|||Mixed Models Analysis||Difference calculated as BI - Placebo.|S-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||7.17|-4.47|0.6980
91664261|NCT04667338|183222329|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Other||||=0.5432
91664262|NCT04667338|183222330|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Treatment||||=0.5432
91664263|NCT04667338|183222330|SUPERIORITY||||||=|0.0397|||||||Chi-squared|||Routine monitoring visits||||=0.0397
91664264|NCT04667338|183222330|SUPERIORITY||||||=|0.0306|||||||Chi-squared|||Tests||||=0.0306
91664265|NCT04667338|183222330|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Emergency visits||||=0.7451
91664266|NCT04667338|183222330|SUPERIORITY||||||=|0.0845|||||||Chi-squared|||Hospitalizations||||=0.0845
91664267|NCT04667338|183222330|SUPERIORITY||||||=|0.3813|||||||Chi-squared|||Complications||||=0.3813
91664268|NCT04667338|183222332|SUPERIORITY||||||=|0.0034|||||||t-test, 2 sided|||Absenteeism||||=0.0034
91664269|NCT04667338|183222332|SUPERIORITY||||||=|0.2178|||||||t-test, 2 sided|||Presenteeism||||=0.2178
91664270|NCT04667338|183222332|SUPERIORITY||||||=|0.1758|||||||t-test, 2 sided|||Work productivity loss||||=0.1758
91664271|NCT04667338|183222332|SUPERIORITY||||||=|0.1789|||||||t-test, 2 sided|||Activity Impairment / disability||||=0.1789
91664272|NCT04667338|183222333|SUPERIORITY||||||=|0.5806|||||||Chi-squared|||||||=0.5806
91664273|NCT04667338|183222335|SUPERIORITY||||||=|0.1602|||||||Chi-squared|||Mobility||||=0.1602
91664274|NCT04667338|183222335|SUPERIORITY||||||=|0.5249|||||||Chi-squared|||Self-Care||||=0.5249
91664275|NCT04667338|183222335|SUPERIORITY||||||=|0.1095|||||||Chi-squared|||Usual activities||||=0.1095
91664276|NCT04667338|183222335|SUPERIORITY||||||=|0.3528|||||||Chi-squared|||Pain / Discomfort||||=0.3528
91664277|NCT04667338|183222335|SUPERIORITY||||||=|0.7434|||||||Chi-squared|||Anxiety / Depression||||=0.7434
91792069|NCT02757950|183461856|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.254||||0.0127|TWO_SIDED|95.0|0.086|0.746||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.746|0.086|0.0127
91627709|NCT04423757|183146840|OTHER||Adjusted mean difference|3.54|STANDARD_ERROR_OF_MEAN|3.1||0.2589|TWO_SIDED|90.0|-1.67|8.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|T-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.76|-1.67|0.2589
91627710|NCT04423757|183146841|OTHER||Adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.4||0.1863|TWO_SIDED|90.0|-0.13|1.15|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||1.15|-0.13|0.1863
91627711|NCT04423757|183146842|OTHER||Adjusted mean difference|0.65|STANDARD_ERROR_OF_MEAN|3.1||0.8326|TWO_SIDED|90.0|-4.46|5.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||5.76|-4.46|0.8326
91627712|NCT04423757|183146843|OTHER||Adjusted mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.4||0.5567|TWO_SIDED|90.0|-0.43|0.89|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||0.89|-0.43|0.5567
91627713|NCT01654523|183146864|SUPERIORITY_OR_OTHER||Mean change in the single arm trial|6.695|STANDARD_DEVIATION|5.505|<|0.05|TWO_SIDED|95.0|4.041|9.348|||Paired t-test|||||9.348|4.041|<0.05
91627714|NCT01575899|183146867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.629|STANDARD_ERROR_OF_MEAN|3.1526||0.008|TWO_SIDED|95.0|1.28|5.42|||Chi-squared|||||5.42|1.28|0.008
91627715|NCT01575899|183146869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|STANDARD_ERROR_OF_MEAN|3.2589||0.004|TWO_SIDED|95.0|1.5|10.02|||Chi-squared|||||10.02|1.5|0.004
91627716|NCT00753688|183146922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.26|0.48||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.48|0.26|<0.001
91627717|NCT00753688|183146923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.12||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||1.12|0.67|0.256
91627718|NCT00753688|183146927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.23|0.6||Stratified two-sided log rank p-value for leiomyosarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.23|<0.001
91627719|NCT00753688|183146927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|95.0|0.19|0.98||Stratified two-sided log rank p-value for synovial sarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.98|0.19|0.005
91627720|NCT00753688|183146927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.25|0.6||Stratified two-sided log rank p-value for other STS histologies|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.25|<0.001
91627721|NCT01854593|183146933|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
91627722|NCT01854593|183146934|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
91627723|NCT01854593|183146935|SUPERIORITY_OR_OTHER|||||||0.033|||||||Fisher Exact|||||||0.033
91627724|NCT01854593|183146936|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91627725|NCT01854593|183146937|SUPERIORITY_OR_OTHER|||||||0.667|||||||Wilcoxon (Mann-Whitney)|||||||0.667
91627726|NCT01854593|183146938|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||||||0.593
91627727|NCT01854593|183146939|SUPERIORITY_OR_OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
91627728|NCT01854593|183146940|SUPERIORITY_OR_OTHER|||||||0.929|||||||Wilcoxon (Mann-Whitney)|||||||0.929
91627729|NCT01854593|183146941|SUPERIORITY_OR_OTHER|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
91627730|NCT01854593|183146942|SUPERIORITY_OR_OTHER|||||||0.131|||||||Chi-squared|||||||0.131
91627731|NCT01854593|183146943|SUPERIORITY_OR_OTHER|||||||0.149|||||||Fisher Exact|||||||0.149
91627732|NCT01854593|183146944|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|||||||0.670
91664278|NCT04667338|183222336|SUPERIORITY||||||=|0.0396|||||||t-test, 2 sided|||||||=0.0396
91664279|NCT04667338|183222337|SUPERIORITY||||||=|0.0394|||||||t-test, 2 sided|||Effectiveness||||=0.0394
91664280|NCT04667338|183222337|SUPERIORITY||||||=|0.3093|||||||t-test, 2 sided|||Convenience||||=0.3093
91664281|NCT04667338|183222337|SUPERIORITY||||||=|0.2296|||||||t-test, 2 sided|||Global satisfaction||||=0.2296
91664282|NCT04667338|183222338|SUPERIORITY||||||=|0.1817|||||||Chi-squared|||Depression||||=0.1817
91664283|NCT04667338|183222338|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Bipolar disorder||||=0.0885
91664284|NCT04667338|183222338|SUPERIORITY||||||=|0.3043|||||||Chi-squared|||Anxiety disorders||||=0.3043
91664285|NCT04667338|183222338|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Panic disorder||||=0.0885
91627733|NCT01854593|183146945|SUPERIORITY_OR_OTHER|||||||0.378|||||||Chi-squared|||||||0.378
91627734|NCT01216397|183146984|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.4||||||90.0|94.2|105.0|||ANOVA|||Standard batch vs. Side batch||105.0|94.2|
91627735|NCT01216397|183146985|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|96.1|104.2|||ANOVA|||Standard batch vs. Side batch||104.2|96.1|
91627736|NCT01216397|183146986|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|94.7|105.8|||ANOVA|||Standard batch vs. Side batch||105.8|94.7|
91627737|NCT01216397|183146994|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.9||||||90.0|92.5|103.7|||ANOVA|||Standard batch vs. Side batch||103.7|92.5|
91627738|NCT01216397|183146995|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.4||||||90.0|95.7|105.4|||ANOVA|||||105.4|95.7|
91664286|NCT04667338|183222338|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Phobia disorder||||=0.5603
91664287|NCT04667338|183222338|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Obsessive compulsive disorder||||=0.5603
91714080|NCT05116202|183319826|SUPERIORITY||Hazard Ratio (HR)|6.27|||||TWO_SIDED|95.0|0.73|53.7||||||||53.70|0.73|
91627739|NCT01216397|183146996|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.3||||||90.0|95.7|105.2|||ANOVA|||Standard batch vs. Side batch||105.2|95.7|
91627740|NCT01455415|183147008|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.3287|TWO_SIDED|95.0|0.83|1.73||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||1.73|0.83|0.3287
91627741|NCT01455415|183147009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.0625|TWO_SIDED|95.0|0.98|2.51||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||2.51|0.98|0.0625
91664288|NCT04667338|183222338|SUPERIORITY||||||=|0.3646|||||||Chi-squared|||Diagnosis of ADHD||||=0.3646
91664289|NCT04667338|183222338|SUPERIORITY||||||=|0.2615|||||||Chi-squared|||Obesity||||=0.2615
91664290|NCT04667338|183222338|SUPERIORITY||||||=|0.3076|||||||Chi-squared|||Endocrine Disorders||||=0.3076
91664291|NCT04667338|183222338|SUPERIORITY||||||=|0.409|||||||Chi-squared|||Peripheral vascular disease||||=0.4090
91664292|NCT04667338|183222338|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Cardiovascular accident or transient ischemic attack (TIA)||||=0.5603
91664293|NCT04667338|183222338|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||COPD||||=0.5603
91664294|NCT04667338|183222338|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Connective tissue disease||||=0.5603
91664295|NCT04667338|183222338|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Liver Disease||||=0.7451
91664296|NCT04667338|183222338|SUPERIORITY||||||=|0.3108|||||||Chi-squared|||Diabetes Mellitus||||=0.3108
91525356|NCT00098254|182926040|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Kaplan-Meier|||||||0.33
91627742|NCT01455415|183147010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9448|TWO_SIDED|95.0|-0.21|0.22||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.22|-0.21|0.9448
91627743|NCT01455415|183147011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4548|TWO_SIDED|95.0|-0.32|0.14||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.14|-0.32|0.4548
91627744|NCT01455415|183147012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.0272|TWO_SIDED|95.0|-0.44|-0.03||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||-0.03|-0.44|0.0272
91664297|NCT04667338|183222338|SUPERIORITY||||||=|0.2407|||||||Chi-squared|||Solid Tumor||||=0.2407
91664298|NCT04667338|183222338|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||AIDS||||=0.5603
91664299|NCT04667338|183222338|SUPERIORITY||||||=|0.1739|||||||Chi-squared|||Others||||=0.1739
91664300|NCT04667338|183222339|SUPERIORITY||||||=|0.3585|||||||t-test, 2 sided|||||||=0.3585
91664301|NCT05604209|183222347|SUPERIORITY||Median log2 fold change|1.63|||<|0.001|TWO_SIDED|95.0|0.67|2.14|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within all vaccinees is zero.||2.14|0.67|<0.001
91664302|NCT05604209|183222347|SUPERIORITY||median log2 fold change|1.15||||0.008|TWO_SIDED|95.0|0.09|2.59|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||2.59|0.09|0.008
91714081|NCT05116202|183319827|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.25|7.75||||||||7.75|0.25|
91714082|NCT05116202|183319827|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.35|12.62||||||||12.62|0.35|
91714083|NCT05116202|183319827|SUPERIORITY||Hazard Ratio (HR)|2.39|||||TWO_SIDED|95.0|0.22|26.32||||||||26.32|0.22|
91714084|NCT05116202|183319828|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.05|12.39||||||||12.39|0.05|
91664303|NCT05604209|183222347|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.93|4.59|||Wilcoxon (Mann-Whitney)|Within-am log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||4.59|0.93|0.008
91664304|NCT05604209|183222347|SUPERIORITY|||||||0.279|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.279
91664305|NCT05604209|183222348|SUPERIORITY||Median log2 fold change|1.66|||<|0.001|TWO_SIDED|95.0|1.09|2.33|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within all vaccinees is zero.||2.33|1.09|<0.001
91664306|NCT05604209|183222348|SUPERIORITY||Median log2 fold change|1.79||||0.008|TWO_SIDED|95.0|0.59|3.4|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||3.40|0.59|0.008
91792070|NCT02757950|183461857|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.638||||0.0036|TWO_SIDED|95.0|0.471|0.863||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.863|0.471|0.0036
91792071|NCT02757950|183461858|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|1.342||||0.0931|TWO_SIDED|95.0|0.952|1.89||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.890|0.952|0.0931
91792072|NCT02216812|183461891|OTHER|||||||0.63|||||||Regression, Linear|||We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.||||0.63
91792073|NCT03036800|183461913|SUPERIORITY||Odds Ratio (OR)|5.19|||<|0.001|TWO_SIDED|95.0|2.09|12.88|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.88|2.09|<0.001
91691918|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.62||0.4209||95.0|-1.77|0.76||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.||0.76|-1.77|0.4209
91482463|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|12.6||||0.0146|TWO_SIDED|95.0|2.6|22.7|||Chi-squared|||37\_Week 10, ≥50% reduction, E4 15 mg vs placebo||22.7|2.6|0.0146
91482464|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|14.2||||0.0055|TWO_SIDED|95.0|4.3|24.1|||Chi-squared|||38\_Week 10, ≥50% reduction, E4 20 mg vs placebo||24.1|4.3|0.0055
91691919|NCT00380874|183278451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.54||0.9657||95.0|-1.06|1.11||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Last Observation Carried Forward (LOCF)endpoint.||1.11|-1.06|0.9657
91691920|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.5392||95.0|-0.24|0.12|||ANCOVA|||Cycle 1.||0.12|-0.24|0.5392
91691921|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5412||95.0|-0.3|0.57|||ANCOVA|||Cycle 2.||0.57|-0.30|0.5412
91482465|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|7.8||||0.1635|TWO_SIDED|95.0|-3.1|18.8|||Chi-squared|||39\_Week 10, ≥75% reduction, E4 15 mg vs placebo||18.8|-3.1|0.1635
91691922|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.34||0.5358||95.0|-0.48|0.9|||ANCOVA|||Cycle 3.||0.90|-0.48|0.5358
91691923|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.41||0.4059||95.0|-0.48|1.17|||ANCOVA|||Cycle 4.||1.17|-0.48|0.4059
91691924|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.2712||95.0|-0.44|1.52|||ANCOVA|||Cycle 5.||1.52|-0.44|0.2712
91691925|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.9181||95.0|-0.81|0.73|||ANCOVA|||Cycle 6.||0.73|-0.81|0.9181
91691926|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.42||0.4357||95.0|-0.52|1.17|||ANCOVA|||Cycle 7.||1.17|-0.52|0.4357
91691927|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.49||0.5103||95.0|-0.67|1.33|||ANCOVA|||||1.33|-0.67|0.5103
91691928|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.58||0.8499||95.0|-1.29|1.07|||ANCOVA|||Cycle 9.||1.07|-1.29|0.8499
91482466|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|14.2||||0.0119|TWO_SIDED|95.0|3.3|25.2|||Chi-squared|||40\_Week 10, ≥75% reduction, E4 20 mg vs placebo||25.2|3.3|0.0119
91482467|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|16.5||||0.0014|TWO_SIDED|95.0|6.5|26.5|||Chi-squared|||41\_Week 11, ≥50% reduction, E4 15 mg vs placebo||26.5|6.5|0.0014
91482468|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|17.7||||0.0006|TWO_SIDED|95.0|7.8|27.6|||Chi-squared|||42\_Week 11, ≥50% reduction, E4 20 mg vs placebo||27.6|7.8|0.0006
91482469|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|15.0||||0.0075|TWO_SIDED|95.0|4.1|25.8|||Chi-squared|||43\_Week 11, ≥75% reduction, E4 15 mg vs placebo||25.8|4.1|0.0075
91482470|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|18.5||||0.001|TWO_SIDED|95.0|7.6|29.3|||Chi-squared|||44\_Week 11, ≥75% reduction, E4 20 mg vs placebo||29.30|7.6|0.0010
91482471|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|20.0||||0.0001|TWO_SIDED|95.0|10.0|29.9|||Chi-squared|||45\_Week 12, ≥50% reduction, E4 15 mg vs placebo||29.9|10.0|0.0001
91482472|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|20.4|||<|0.0001|TWO_SIDED|95.0|10.5|30.3|||Chi-squared|||46\_Week 12, ≥50% reduction, E4 20 mg vs placebo||30.3|10.5|<0.0001
91482473|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|11.7||||0.0392|TWO_SIDED|95.0|0.7|22.7|||Chi-squared|||47\_Week 12, ≥75% reduction, E4 15 mg vs placebo||22.7|0.7|0.0392
91664307|NCT05604209|183222348|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.94|3.09|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||3.09|0.94|0.008
91482474|NCT04090957|182838748|SUPERIORITY||Risk Difference (RD)|19.5||||0.0007|TWO_SIDED|95.0|8.5|30.6|||Chi-squared|||48\_Week 12, ≥75% reduction, E4 20 mg vs placebo||30.6|8.5|0.0007
91482475|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|1.8||||0.7283|TWO_SIDED|95.0|-8.4|12.0|||Chi-squared|||1\_Week 4, CID, E4 15 mg vs Placebo||12.0|-8.4|0.7283
91482476|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|16.7||||0.0017|TWO_SIDED|95.0|6.4|27.0|||Chi-squared|||2\_Week 4, CID, E4 20 mg vs Placebo||27.0|6.4|0.0017
91664308|NCT05604209|183222348|SUPERIORITY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.878
91482477|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|8.9||||0.095|TWO_SIDED|95.0|-1.5|19.3|||Chi-squared|||3\_Week 4, MCID, E4 15 mg vs Placebo||19.3|-1.5|0.0950
91482478|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-7.9||||0.1208|TWO_SIDED|95.0|-17.8|2.0|||Chi-squared|||4\_Week 4, MCID, E4 20 mg vs Placebo||2.0|-17.8|0.1208
91482479|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-10.7||||0.0154|TWO_SIDED|95.0|-19.3|-2.1|||Chi-squared|||5\_Week 4, Worsen/No change, E4 15 mg vs Placebo||-2.1|-19.3|0.0154
91482480|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-8.9||||0.0461|TWO_SIDED|95.0|-17.6|-0.2|||Chi-squared|||6\_Week 4, Worsen/No change, E4 20 mg vs Placebo||-0.2|-17.6|0.0461
91482481|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|10.7||||0.0629|TWO_SIDED|95.0|-0.5|22.0|||Chi-squared|||7\_Week 12, CID, E4 15 mg vs Placebo||22.0|-0.5|0.0629
91482482|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|18.6||||0.0012|TWO_SIDED|95.0|7.5|29.6|||Chi-squared|||8\_Week 12, CID, E4 20 mg vs Placebo||29.6|7.5|0.0012
91482483|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-4.9||||0.3552|TWO_SIDED|95.0|-15.3|5.5|||Chi-squared|||9\_Week 12, MCID, E4 15 mg vs Placebo||5.5|-15.3|0.3552
91482484|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-13.1||||0.0103|TWO_SIDED|95.0|-22.9|-3.2|||Chi-squared|||10\_Week 12, MCID, E4 20 mg vs Placebo||-3.2|-22.9|0.0103
91482485|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-5.8||||0.1383|TWO_SIDED|95.0|-13.5|1.9|||Chi-squared|||11\_Week 12, Worsen/No change, E4 15 mg vs Placebo||1.9|-13.5|0.1383
91482486|NCT04090957|182838749|SUPERIORITY||Risk Difference (RD)|-5.5||||0.1706|TWO_SIDED|95.0|-13.3|2.3|||Chi-squared|||12\_Week 12, Worsen/No change, E4 20 mg vs Placebo||2.3|-13.3|0.1706
91482487|NCT04090957|182838750|SUPERIORITY||Least square mean difference|-0.15||||0.1565|TWO_SIDED|95.0|-0.34|0.04|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.04|-0.34|0.1565
91482488|NCT04090957|182838750|SUPERIORITY||Least square mean difference|-0.14||||0.1823|TWO_SIDED|95.0|-0.33|0.05|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||0.05|-0.33|0.1823
91482489|NCT04090957|182838750|SUPERIORITY||Least square mean difference|-0.23||||0.046|TWO_SIDED|95.0|-0.46|0.0|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-0.00|-0.46|0.0460
91482490|NCT04090957|182838750|SUPERIORITY||Least square mean difference|-0.24||||0.0417|TWO_SIDED|95.0|-0.47|-0.01|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||-0.01|-0.47|0.0417
91482491|NCT04090957|182838752|SUPERIORITY||Least square mean difference|-0.08||||0.4616|TWO_SIDED|95.0|-0.24|0.09|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.09|-0.24|0.4616
91482492|NCT04090957|182838752|SUPERIORITY||Least square mean difference|-0.2||||0.0112|TWO_SIDED|95.0|-0.37|-0.04|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-0.04|-0.37|0.0112
91482493|NCT04090957|182838752|SUPERIORITY||Least square mean difference|-0.12||||0.2773|TWO_SIDED|95.0|-0.32|0.07|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.07|-0.32|0.2773
91482494|NCT04090957|182838752|SUPERIORITY||Least square mean difference|-0.09||||0.4881|TWO_SIDED|95.0|-0.29|0.11|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.11|-0.29|0.4881
91525357|NCT00098254|182926041|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Kaplan-Meier|||||||0.042
91664309|NCT05604209|183222349|SUPERIORITY||Median log2 fold change|1.47|||<|0.001|TWO_SIDED|95.0|0.54|2.63|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within all vaccinees is zero.||2.63|0.54|<0.001
91714085|NCT05116202|183319828|SUPERIORITY||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|0.23|28.65||||||||28.65|0.23|
91792074|NCT03036800|183461914|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.45|14.4|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.4|2.45|<0.001
91792075|NCT03036800|183461915|SUPERIORITY||Odds Ratio (OR)|5.04||||0.002|TWO_SIDED|95.0|1.81|14.01|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.01|1.81|0.002
91627745|NCT01455415|183147013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7344|TWO_SIDED|95.0|-0.42|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.42|0.7344
91627746|NCT01455415|183147014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.6007|TWO_SIDED|95.0|-0.42|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.42|0.6007
91627747|NCT01455415|183147015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.04||0.2987|TWO_SIDED|95.0|-3.13|0.96||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.96|-3.13|0.2987
91627748|NCT01455415|183147016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1769|TWO_SIDED|95.0|-0.85|0.16||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.16|-0.85|0.1769
91627749|NCT01455415|183147017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5119|TWO_SIDED|95.0|-0.48|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.48|0.5119
91627750|NCT01455415|183147018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.4335|TWO_SIDED|95.0|-1.72|0.74||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.74|-1.72|0.4335
91627751|NCT01455415|183147019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.9653|TWO_SIDED|95.0|-0.31|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.31|0.9653
91714086|NCT05116202|183319828|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.07|18.58||||||||18.58|0.07|
91714087|NCT05116202|183319829|SUPERIORITY||Difference in ORR|-21.59|||||TWO_SIDED|95.0|-50.55|7.37||||||||7.37|-50.55|
91714088|NCT05116202|183319829|SUPERIORITY||Difference in ORR|-24.09|||||TWO_SIDED|95.0|-58.17|9.99||||||||9.99|-58.17|
91714089|NCT05116202|183319829|SUPERIORITY||Difference in ORR|0.91|||||TWO_SIDED|95.0|-33.58|35.4||||||||35.40|-33.58|
91714090|NCT01852513|183319841|SUPERIORITY|||||||0.391|||||||t-test, 2 sided|||||||0.391
91792076|NCT03036800|183461916|SUPERIORITY||Odds Ratio (OR)|5.24||||0.002|TWO_SIDED|95.0|1.88|14.64|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.64|1.88|0.002
91792077|NCT03036800|183461933|SUPERIORITY||Odds Ratio (OR)|10.12|||<|0.001|TWO_SIDED|95.0|5.26|19.48|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||19.48|5.26|<0.001
91792078|NCT03036800|183461934|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.86|9.36|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||9.36|2.86|<0.001
91525358|NCT00098254|182926042|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Kaplan-Meier|||||||0.028
91482495|NCT04090957|182838754|SUPERIORITY||Least square mean difference|-0.02||||0.7875|TWO_SIDED|95.0|-0.08|0.04|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.040|-0.08|0.7875
91482496|NCT04090957|182838754|SUPERIORITY||Least square mean difference|0.04||||0.3092|TWO_SIDED|95.0|-0.02|0.1|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||0.10|-0.02|0.3092
91482497|NCT04090957|182838754|SUPERIORITY||Least square mean difference|-0.01||||0.9129|TWO_SIDED|95.0|-0.08|0.06|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.06|-0.08|0.9129
91482498|NCT04090957|182838754|SUPERIORITY||Least square mean difference|-0.02||||0.8023|TWO_SIDED|95.0|-0.09|0.06|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.06|-0.09|0.8023
91482499|NCT04090957|182838756|SUPERIORITY||Least square mean difference|-0.23||||0.0084|TWO_SIDED|95.0|-0.41|-0.05|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-0.05|-0.41|0.0084
91627752|NCT01455415|183147020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12||0.269|TWO_SIDED|95.0|-0.38|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.38|0.2690
91627753|NCT01455415|183147021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9951|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9951
91664310|NCT05604209|183222349|SUPERIORITY||Median log2 fold change|1.09||||0.008|TWO_SIDED|95.0|0.39|3.61|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.61|0.39|0.008
91482500|NCT04090957|182838756|SUPERIORITY||Least square mean difference|-0.21||||0.0146|TWO_SIDED|95.0|-0.39|-0.04|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-0.04|-0.39|0.0146
91482501|NCT04090957|182838756|SUPERIORITY||Least square mean difference|-0.3||||0.0029|TWO_SIDED|95.0|-0.51|-0.09|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-0.09|-0.51|0.0029
91482502|NCT04090957|182838756|SUPERIORITY||Least square mean difference|-0.3||||0.0045|TWO_SIDED|95.0|-0.51|-0.08|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||-0.08|-0.51|0.0045
91482503|NCT04090957|182838758|SUPERIORITY||Least square mean difference|-3.34||||0.0026|TWO_SIDED|95.0|-5.63|-1.05|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-1.05|-5.63|0.0026
91664311|NCT05604209|183222349|SUPERIORITY||Median log2 fold change|2.0||||0.016|TWO_SIDED|95.0|0.43|4.37|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C1C62-M3M4 vaccinated arm is zero.||4.37|0.43|0.016
91691929|NCT00380874|183278452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.39||0.7359||95.0|-0.9|0.64|||ANCOVA|||LOCF endpoint.||0.64|-0.90|0.7359
91482504|NCT04090957|182838758|SUPERIORITY||Least square mean difference|-4.03||||0.0002|TWO_SIDED|95.0|-6.31|-1.75|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-1.75|-6.31|0.0002
91482505|NCT04090957|182838758|SUPERIORITY||Least square mean difference|-3.01||||0.0295|TWO_SIDED|95.0|-5.75|-0.26|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-0.26|-5.75|0.0295
91482506|NCT04090957|182838758|SUPERIORITY||Least square mean difference|-2.73||||0.0564|TWO_SIDED|95.0|-5.53|0.06|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.06|-5.53|0.0564
91482507|NCT04090957|182838760|SUPERIORITY||Least square mean difference|0.24||||0.0051|TWO_SIDED|95.0|0.06|0.42|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.42|0.06|0.0051
91482508|NCT04090957|182838760|SUPERIORITY||Least square mean difference|0.22||||0.0126|TWO_SIDED|95.0|0.04|0.4|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||0.40|0.04|0.0126
91482509|NCT04090957|182838760|SUPERIORITY||Least square mean difference|0.14||||0.2372|TWO_SIDED|95.0|-0.07|0.35|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.35|-0.07|0.2372
91482510|NCT04090957|182838760|SUPERIORITY||Least square mean difference|0.2||||0.0644|TWO_SIDED|95.0|-0.01|0.42|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.42|-0.01|0.0644
91482511|NCT04090957|182838762|SUPERIORITY||Least square mean difference|-0.04||||0.5631|TWO_SIDED|95.0|-0.12|0.05|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.05|-0.12|0.5631
91482512|NCT04090957|182838762|SUPERIORITY||Least square mean difference|-0.11||||0.0174|TWO_SIDED|95.0|-0.2|-0.02|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-0.02|-0.20|0.0174
91482513|NCT04090957|182838762|SUPERIORITY||Least square mean difference|0.0||||0.9992|TWO_SIDED|95.0|-0.1|0.1|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.10|-0.10|0.9992
91482514|NCT04090957|182838762|SUPERIORITY||Least square mean difference|-0.07||||0.2941|TWO_SIDED|95.0|-0.17|0.04|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.04|-0.17|0.2941
91482515|NCT04090957|182838764|SUPERIORITY||Least square mean difference|-0.06||||0.7112|TWO_SIDED|95.0|-0.24|0.12|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.12|-0.24|0.7112
91482516|NCT04090957|182838764|SUPERIORITY||Least square mean difference|-0.1||||0.3618|TWO_SIDED|95.0|-0.28|0.08|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||0.08|-0.28|0.3618
91482517|NCT04090957|182838764|SUPERIORITY||Least square mean difference|-0.01||||0.9933|TWO_SIDED|95.0|-0.23|0.21|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.21|-0.23|0.9933
91627754|NCT01455415|183147022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9726|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9726
91627755|NCT01455415|183147023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5497|TWO_SIDED|95.0|-0.04|0.08||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.08|-0.04|0.5497
91627756|NCT01455415|183147024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1495|TWO_SIDED|95.0|-0.02|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.02|0.1495
91627757|NCT01455415|183147025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1297|TWO_SIDED|95.0|-0.11|0.01||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.01|-0.11|0.1297
91627758|NCT01455415|183147026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4279|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.4279
91664312|NCT05604209|183222349|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.189
91664313|NCT05604209|183222350|SUPERIORITY||Median log2 fold change|1.78|||<|0.001|TWO_SIDED|95.0|0.81|2.51|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within all vaccinees is zero.||2.51|0.81|<0.001
91714091|NCT01852513|183319842|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||||||0.789
91792079|NCT03036800|183461935|SUPERIORITY||Odds Ratio (OR)|4.16|||<|0.001|TWO_SIDED|95.0|2.39|7.22|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||7.22|2.39|<0.001
91664314|NCT05604209|183222350|SUPERIORITY||Median log2 fold change|1.57||||0.008|TWO_SIDED|95.0|0.63|3.89|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.89|0.63|0.008
91482518|NCT04090957|182838764|SUPERIORITY||Least square mean difference|0.099||||0.9024|TWO_SIDED|95.0|-0.18|0.26|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.26|-0.18|0.9024
91691930|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2034||95.0|-0.06|0.29|||ANCOVA|||Burning Spontaneous Pain Cycle 3||0.29|-0.06|0.2034
91691931|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.3062||95.0|-0.4|0.13|||ANCOVA|||Burning Spontaneous Pain Cycle 4||0.13|-0.40|0.3062
91691932|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2787||95.0|-0.37|0.11|||ANCOVA|||Burning Spontaneous Pain Cycle 5||0.11|-0.37|0.2787
91691933|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.4124||95.0|-0.2|0.47|||ANCOVA|||Burning Spontaneous Pain Cycle 6||0.47|-0.20|0.4124
91691934|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.35||0.9541||95.0|-0.68|0.73|||ANCOVA|||Burning Spontaneous Pain Cycle 7||0.73|-0.68|0.9541
91482519|NCT04090957|182838766|SUPERIORITY||Least square mean difference|-0.16||||0.8961|TWO_SIDED|95.0|-1.05|0.74|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.74|-1.05|0.8961
91691935|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3383||95.0|-0.33|0.92|||ANOVA|||Burning Spontaneous Pain Cycle 8||0.92|-0.33|0.3383
91691936|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.8918||95.0|-0.84|0.74|||ANCOVA|||Burning Spontaneous Pain||0.74|-0.84|0.8918
91482520|NCT04090957|182838766|SUPERIORITY||Least square mean difference|-0.09||||0.9619|TWO_SIDED|95.0|-0.99|0.81|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||0.81|-0.99|0.9619
91482521|NCT04090957|182838766|SUPERIORITY||Least square mean difference|-0.2||||0.892|TWO_SIDED|95.0|-1.33|0.92|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.92|-1.33|0.8920
91482522|NCT04090957|182838766|SUPERIORITY||Least square mean difference|0.73||||0.2826|TWO_SIDED|95.0|-0.43|1.89|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||1.89|-0.43|0.2826
91482523|NCT04090957|182838768|SUPERIORITY||Least square mean difference|-3.87||||0.9039|TWO_SIDED|95.0|-26.86|19.12|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||19.12|-26.86|0.9039
91482524|NCT04090957|182838768|SUPERIORITY||Least square mean difference|-2.24||||0.966|TWO_SIDED|95.0|-25.12|20.63|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||20.63|-25.12|0.9660
91482525|NCT04090957|182838768|SUPERIORITY||Least square mean difference|-5.73||||0.8708|TWO_SIDED|95.0|-34.55|23.08|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||23.08|-34.55|0.8708
91482526|NCT04090957|182838768|SUPERIORITY||Least square mean difference|17.15||||0.3357|TWO_SIDED|95.0|-12.48|46.77|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||46.77|-12.48|0.3357
91482527|NCT04090957|182838770|SUPERIORITY||Least square mean difference|17.36|||<|0.0001|TWO_SIDED|95.0|12.76|21.96|||Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||21.96|12.76|< 0.0001
91482528|NCT04090957|182838770|SUPERIORITY||Least square mean difference|19.39|||<|0.0001|TWO_SIDED|95.0|14.8|23.98|||Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||23.98|14.80|<0.0001
91525359|NCT02118337|182926053|SUPERIORITY||Rate difference|-23.8||||0.5494|TWO_SIDED|95.0|-72.8|31.1|||Fisher Exact|||||31.1|-72.8|0.5494
91525360|NCT02118337|182926053|SUPERIORITY||Rate difference|-7.1||||0.513|TWO_SIDED|95.0|-33.6|20.0|||Fisher Exact|||||20.0|-33.6|0.5130
91482529|NCT04090957|182838770|SUPERIORITY||Least square mean difference|17.44|||<|0.0001|TWO_SIDED|95.0|12.05|22.83|||Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||22.83|12.05|<0.0001
91525361|NCT01121172|182926120|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Non parametric test||||||0.001
91691937|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.26||0.9614||95.0|-0.54|0.51|||ANCOVA|||Burning Spontaneous Pain LOCF endpoint||0.51|-0.54|0.9614
91482530|NCT04090957|182838770|SUPERIORITY||Least square mean difference|20.19|||<|0.0001|TWO_SIDED|95.0|14.5|25.89|||Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||25.89|14.50|<0.0001
91714092|NCT01852513|183319843|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
91482531|NCT04090957|182838771|SUPERIORITY||Least square mean difference|-8.28|||<|0.0001|TWO_SIDED|95.0|-11.86|-4.7|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-4.70|-11.86|<0.0001
91482532|NCT04090957|182838771|SUPERIORITY||Least square mean difference|-8.25|||<|0.0001|TWO_SIDED|95.0|-11.9|-4.61|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-4.61|-11.90|< 0.0001
91482533|NCT04090957|182838771|SUPERIORITY||Least square mean difference|-7.68||||0.0002|TWO_SIDED|95.0|-12.07|-3.29|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-3.29|-12.07|0.0002
91482534|NCT04090957|182838771|SUPERIORITY||Least square mean difference|-5.51||||0.0181|TWO_SIDED|95.0|-10.21|-0.82|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||-0.82|-10.21|0.0181
91482535|NCT04090957|182838772|SUPERIORITY||Least square mean difference|-0.01||||0.8862|TWO_SIDED|95.0|-0.08|0.05|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||0.05|-0.08|0.8862
91482536|NCT04090957|182838772|SUPERIORITY||Least square mean difference|-0.02||||0.6013|TWO_SIDED|95.0|-0.09|0.04|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||0.04|-0.09|0.6013
91482537|NCT04090957|182838772|SUPERIORITY||Least square mean difference|-0.01||||0.9723|TWO_SIDED|95.0|-0.08|0.07|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.07|-0.08|0.9723
91482538|NCT04090957|182838772|SUPERIORITY||Least square mean difference|-0.03||||0.5778|TWO_SIDED|95.0|-0.11|0.05|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.05|-0.11|0.5778
91482539|NCT04090957|182838773|SUPERIORITY||Least square mean difference|5.86||||0.9865|TWO_SIDED|95.0|-89.5|101.23|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||101.23|-89.50|0.9865
91482540|NCT04090957|182838773|SUPERIORITY||Least square mean difference|-7.05||||0.9814|TWO_SIDED|95.0|-104.73|90.63|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||90.63|-104.73|0.9814
91482541|NCT04090957|182838773|SUPERIORITY||Least square mean difference|-46.46||||0.6049|TWO_SIDED|95.0|-167.23|74.3|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||74.30|-167.23|0.6049
91482542|NCT04090957|182838773|SUPERIORITY||Least square mean difference|-71.64||||0.3717|TWO_SIDED|95.0|-202.08|58.81|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||58.81|-202.08|0.3717
91482543|NCT04090957|182838774|SUPERIORITY||Least square mean difference|1.93||||0.8439|TWO_SIDED|95.0|-6.89|10.74|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||10.74|-6.89|0.8439
91525362|NCT01121172|182926121|SUPERIORITY_OR_OTHER|||||||0.232|||||||Chi-squared|Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution||||||0.232
91525363|NCT01003639|182926122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|95.0|0.0|1.43|||ANCOVA|||||1.43|0|0.05
91525364|NCT05458024|182926126|SUPERIORITY||Beta coefficient|-0.14||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
91525365|NCT05458024|182926127|SUPERIORITY||Beta coefficient|-1.41||||0.21|TWO_SIDED|||||Analyses were adjusted for sex, baseline pain, and baseline vitamin D levels.|Mixed Models Analysis|||||||0.21
91525366|NCT05807919|182926138|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91525367|NCT05807919|182926139|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
91525368|NCT05807919|182926140|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
91525369|NCT05807919|182926141|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91691938|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3022||95.0|-0.17|0.05|||ANCOVA|||Pressing Spontaneous Pain Cycle 2||0.05|-0.17|0.3022
91482544|NCT04090957|182838774|SUPERIORITY||Least square mean difference|5.66||||0.2727|TWO_SIDED|95.0|-3.28|14.61|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||14.61|-3.28|0.2727
91482545|NCT04090957|182838774|SUPERIORITY||Least square mean difference|-3.86||||0.6389|TWO_SIDED|95.0|-14.53|6.81|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||6.81|-14.53|0.6389
91664315|NCT05604209|183222350|SUPERIORITY||Median log2 fold change|1.78||||0.016|TWO_SIDED|95.0|0.7|3.79|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C162-M3M4 vaccinated arm is zero.||3.79|0.70|0.016
91482546|NCT04090957|182838774|SUPERIORITY||Least square mean difference|5.52||||0.4544|TWO_SIDED|95.0|-5.84|16.88|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||16.88|-5.84|0.4544
91482547|NCT04090957|182838775|SUPERIORITY||Least square mean difference|0.57||||0.0084|TWO_SIDED|95.0|0.13|1.02|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||1.02|0.13|0.0084
91482548|NCT04090957|182838775|SUPERIORITY||Least square mean difference|0.77||||0.0002|TWO_SIDED|95.0|0.33|1.2|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||1.20|0.33|0.0002
91482549|NCT04090957|182838775|SUPERIORITY||Least square mean difference|0.19||||0.6337|TWO_SIDED|95.0|-0.33|0.72|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.72|-0.33|0.6337
91627759|NCT01455415|183147027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5505|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.5505
91627760|NCT01455415|183147028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0604|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.0604
91627761|NCT01455415|183147029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.106||0.7174|TWO_SIDED|95.0|-0.248|0.171||Primary analysis was two-sided and performed at the 0.05 significance level.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.||0.171|-0.248|0.7174
91627762|NCT01455415|183147030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.1511
91627763|NCT02460978|183147042|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.0579|<|0.0001|TWO_SIDED|95.0|-0.49|-0.26|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.26|-0.49|<0.0001
91627764|NCT02460978|183147042|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0578|<|0.0001|TWO_SIDED|95.0|-0.53|-0.3|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.30|-0.53|<0.0001
91627765|NCT02460978|183147043|SUPERIORITY||Mean Difference (Final Values)|-10.78|STANDARD_ERROR_OF_MEAN|1.5291|<|0.0001|TWO_SIDED|95.0|-13.73|-7.72|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-7.72|-13.73|<0.0001
91627766|NCT02460978|183147043|SUPERIORITY||Mean Difference (Final Values)|-11.08|STANDARD_ERROR_OF_MEAN|1.5331|<|0.0001|TWO_SIDED|95.0|-14.04|-8.02|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-8.02|-14.04|<0.0001
91627767|NCT02460978|183147044|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.3829|<|0.0001|TWO_SIDED|95.0|-3.96|-2.45|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.45|-3.96|<0.0001
91664316|NCT05604209|183222350|SUPERIORITY|||||||0.955|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.955
91714093|NCT01871077|183319844|OTHER|||||||0.89|||||||Friedman test|||||||0.890
91482550|NCT04090957|182838775|SUPERIORITY||Least square mean difference|0.44||||0.1287|TWO_SIDED|95.0|-0.1|0.98|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.98|-0.10|0.1287
91482551|NCT04090957|182838776|SUPERIORITY||Least square mean difference|-2.45||||0.3445|TWO_SIDED|95.0|-6.76|1.86|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||1.86|-6.76|0.3445
91482552|NCT04090957|182838776|SUPERIORITY||Least square mean difference|0.03||||0.9998|TWO_SIDED|95.0|-4.33|4.4|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||4.40|-4.33|0.9998
91482553|NCT04090957|182838776|SUPERIORITY||Least square mean difference|-2.38||||0.4874|TWO_SIDED|95.0|-7.51|2.76|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||2.76|-7.51|0.4874
91525370|NCT05807919|182926142|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
91714094|NCT01871077|183319845|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||||||0.078
91664317|NCT05604209|183222351|SUPERIORITY||Median Difference (Net)|2.0||||0.125|TWO_SIDED|95.0|-1.0|4.0|||Wilcoxon (Mann-Whitney)|Within-group changes in breadth from baseline to day 56 were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median change in breadth of T-cell response to HIV-1 subpools from baseline to day 56 within all vaccinees is zero.||4|-1|0.125
91664318|NCT02597049|183222366|SUPERIORITY||Mean Difference (Final Values)|-0.79|||<|0.001|TWO_SIDED|95.0|-0.97|-0.61|||Mixed Models Analysis|||||-0.61|-0.97|<.001
91627768|NCT02460978|183147044|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.3812|<|0.0001|TWO_SIDED|95.0|-4.49|-2.99|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.99|-4.49|<0.0001
91627769|NCT02460978|183147045|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|2.3468|<|0.0001|TWO_SIDED|95.0|-20.26|-11.05|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-11.05|-20.26|<0.0001
91627770|NCT02460978|183147045|SUPERIORITY||Mean Difference (Final Values)|-19.74|STANDARD_ERROR_OF_MEAN|2.3419|<|0.0001|TWO_SIDED|95.0|-24.34|-15.14|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-15.14|-24.34|<0.0001
91627771|NCT02460978|183147046|SUPERIORITY||Mean Difference (Final Values)|-9.85|STANDARD_ERROR_OF_MEAN|2.4519|<|0.0001|TWO_SIDED|95.0|-14.66|-5.03|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-5.03|-14.66|<0.0001
91664319|NCT02597049|183222366|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.84|-0.49|||Mixed Models Analysis|||||-0.49|-0.84|< .001
91664320|NCT02597049|183222367|SUPERIORITY||Mean Difference (Final Values)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.0|-0.64|||Mixed Models Analysis|||||-0.64|-1.00|<.001
91664321|NCT02597049|183222367|SUPERIORITY||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.86|-0.51|||Mixed Models Analysis|||||-0.51|-0.86|<.001
91664322|NCT02597049|183222368|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
91664323|NCT02597049|183222368|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
91664324|NCT02597049|183222368|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
91664325|NCT02597049|183222368|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
91664326|NCT02597049|183222369|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.027|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||Treatment-regimen Estimand||-0.1|-1.8|0.027
91664327|NCT02597049|183222369|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.264|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Treatment-regimen Estimand||0.4|-1.3|0.264
91664328|NCT02597049|183222369|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.059|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||Efficacy Estimand||0.0|-1.7|0.059
91664329|NCT02597049|183222369|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.435|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||Efficacy Estimand||0.5|-1.2|0.435
91664330|NCT02597049|183222370|SUPERIORITY||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-30.8|-18.6|||ANCOVA|||Treatment-regimen Estimand||-18.6|-30.8|< .001
91627772|NCT02460978|183147046|SUPERIORITY||Mean Difference (Final Values)|-9.36|STANDARD_ERROR_OF_MEAN|2.4487||0.0001|TWO_SIDED|95.0|-14.16|-4.55|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-4.55|-14.16|0.0001
91627773|NCT02460978|183147047|SUPERIORITY||Mean Difference (Final Values)|9.02|STANDARD_ERROR_OF_MEAN|1.0415|<|0.0001|TWO_SIDED|95.0|6.97|11.06|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||11.06|6.97|<0.0001
91627774|NCT02460978|183147047|SUPERIORITY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|1.0396|<|0.0001|TWO_SIDED|95.0|8.66|12.74|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||12.74|8.66|<0.0001
91627775|NCT02460978|183147048|SUPERIORITY||Odds Ratio (OR)|2.71|STANDARD_ERROR_OF_MEAN|0.2058|<|0.0001|TWO_SIDED|95.0|1.81|4.06|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.06|1.81|<0.0001
91664331|NCT02597049|183222370|SUPERIORITY||Mean Difference (Final Values)|-19.6|||<|0.001|TWO_SIDED|95.0|-25.7|-13.5||Test was not controlled for type I error.|ANCOVA|||Treatment-regimen Estimand||-13.5|-25.7|<0.001
91664332|NCT02597049|183222370|SUPERIORITY||Mean Difference (Final Values)|-26.6|||<|0.001|TWO_SIDED|95.0|-32.7|-20.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-20.6|-32.7|<0.001
91664333|NCT02597049|183222370|SUPERIORITY||Mean Difference (Final Values)|-20.7|||<|0.001|TWO_SIDED|95.0|-26.7|-14.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-14.6|-26.7|<0.001
91714095|NCT01871077|183319846|OTHER|||||||1|||||||Friedman test|||||||1.000
91664334|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-19.7|||<|0.001|TWO_SIDED|95.0|-25.7|-13.8|||Mixed Models Analysis|||Pre-morning meal.||-13.8|-25.7|< .001
91664335|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-21.2|-9.2|||Mixed Models Analysis|||Pre-morning meal||-9.2|-21.2|< .001
91664336|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-33.8|-15.3|||Mixed Models Analysis|||2-hour postprandial||-15.3|-33.8|< .001
91664337|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-30.3|-11.8|||Mixed Models Analysis|||2-hour postprandial||-11.8|-30.3|< .001
91664338|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-18.3|||<|0.001|TWO_SIDED|95.0|-26.4|-10.2|||Mixed Models Analysis|||Pre-midday meal||-10.2|-26.4|< .001
91664339|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.5|-6.2|||Mixed Models Analysis|||Pre-midday meal||-6.2|-22.5|< .001
91664340|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-19.0|||<|0.001|TWO_SIDED|95.0|-28.8|-9.3|||Mixed Models Analysis|||2-hour postprandial after midday meal||-9.3|-28.8|< .001
91714096|NCT01871077|183319847|OTHER|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||||||.497
91714097|NCT02864407|183319866|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
91482554|NCT04090957|182838776|SUPERIORITY||Least square mean difference|-0.17||||0.9964|TWO_SIDED|95.0|-5.61|5.26|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||5.26|-5.61|0.9964
91482555|NCT04090957|182838777|SUPERIORITY||Least square mean difference|-3.94||||0.0119|TWO_SIDED|95.0|-7.12|-0.76|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-0.76|-7.12|0.0119
91482556|NCT04090957|182838777|SUPERIORITY||Least square mean difference|-4.77||||0.0017|TWO_SIDED|95.0|-7.93|-1.62|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-1.62|-7.93|0.0017
91482557|NCT04090957|182838777|SUPERIORITY||Least square mean difference|-4.56||||0.0186|TWO_SIDED|95.0|-8.46|-0.66|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-0.66|-8.46|0.0186
91482558|NCT04090957|182838777|SUPERIORITY||Least square mean difference|-3.79||||0.0687|TWO_SIDED|95.0|-7.81|0.24|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||0.24|-7.81|0.0687
91482559|NCT04090957|182838778|SUPERIORITY||Least square mean difference|27.9|||<|0.0001|TWO_SIDED|95.0|16.4|39.41|||Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||39.41|16.40|<0.0001
91482560|NCT04090957|182838778|SUPERIORITY||Least square mean difference|44.99|||<|0.0001|TWO_SIDED|95.0|33.53|56.44|||Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||56.44|33.53|<0.0001
91482561|NCT04090957|182838778|SUPERIORITY||Least square mean difference|29.92|||<|0.0001|TWO_SIDED|95.0|17.13|42.71|||Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||42.71|17.13|<0.0001
91482562|NCT04090957|182838778|SUPERIORITY||Least square mean difference|49.15|||<|0.0001|TWO_SIDED|95.0|35.92|62.37|||Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||62.37|35.92|<0.0001
91482563|NCT04090957|182838779|SUPERIORITY||Least square mean difference|-0.04||||0.0004|TWO_SIDED|95.0|-0.07|-0.02|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-0.02|-0.07|0.0004
91525371|NCT05807919|182926143|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
91525372|NCT03489057|182926152|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
91525373|NCT03489057|182926166|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
91627776|NCT02460978|183147048|SUPERIORITY||Odds Ratio (OR)|3.07|STANDARD_ERROR_OF_MEAN|0.2054|<|0.0001|TWO_SIDED|95.0|2.05|4.6|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.60|2.05|<0.0001
91627777|NCT01142193|183147050|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
91627778|NCT01142193|183147050|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.5|||||TWO_SIDED|95.0|8.53|28.1|||Hodges-Lehmann|||||28.1|8.53|
91627779|NCT01142193|183147051|SUPERIORITY_OR_OTHER||Difference in Percentages|14.7||||0.013|||||||Fisher Exact|||||||0.013
91627780|NCT01142193|183147052|SUPERIORITY_OR_OTHER||Difference in Percentages|16.3||||0.007|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.007
91627781|NCT01142193|183147053|SUPERIORITY_OR_OTHER||Median Difference (Net)|25.36|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91627782|NCT01142193|183147054|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91627783|NCT01142193|183147058|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.61||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91627784|NCT01142193|183147059|SUPERIORITY_OR_OTHER||Difference in Percentages|13.4||||0.048|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.048
91627785|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.||||||0.09|||||||Paired t-test|||P-value comparing AL between G6 and IOLM||||0.09
91627786|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing AL between G6 and LS||||<0.001
91627787|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing AL between IOLM and LS||||<0.0001
91627788|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing CCT between G6 and LS||||<0.0001
91627789|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing ACD between G6 and IOLM||||<0.0001
91627790|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing ACD between G6 and LS||||<0.01
91627791|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.02|||||||Paired t-test|||P-value comparing ACD between IOLM and LS||||0.02
91627792|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing LT between G6 and LS||||<0.01
91627793|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and IOLM||||<0.0001
91627794|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and LS||||<0.0001
91627795|NCT01961089|183147086|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing WtW between IOLM and LS||||<0.001
91627796|NCT01961089|183147087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.||||0.05
91627797|NCT01961089|183147088|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.13|||||||Paired t-test|||P-value comparing SimK between G6 and IOLM||||0.13
91627798|NCT01961089|183147088|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.25|||||||Paired t-test|||P-value comparing SimK between G6 and LS||||0.25
91627799|NCT01961089|183147088|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.21|||||||Paired t-test|||P-value comparing SimK between IOLM and LS||||0.21
91627800|NCT01062009|183147098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||Chi square analysis comparing number of participants with new fever in each group||||0.24
91627801|NCT01731990|183147123|SUPERIORITY_OR_OTHER_LEGACY||Treatment effect for ratio to placebo|1.06||||0.284|TWO_SIDED|90.0|0.97|1.15|||Mixed Models Analysis|||||1.15|0.97|0.284
91627802|NCT01183104|183147129|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was 0.3%.|LS mean difference|0.11||||0.087|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|||||0.24|-0.02|0.087
91627803|NCT01183104|183147130|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
91664341|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.01|TWO_SIDED|95.0|-22.5|-3.1|||Mixed Models Analysis|||2-hour postprandial after midday meal||-3.1|-22.5|0.010
91664342|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-22.7|||<|0.001|TWO_SIDED|95.0|-30.7|-14.7|||Mixed Models Analysis|||Pre-evening meal||-14.7|-30.7|< .001
91664343|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-22.5|||<|0.001|TWO_SIDED|95.0|-30.7|-14.4|||Mixed Models Analysis|||Pre-evening meal||-14.4|-30.7|< .001
91714098|NCT02864407|183319867|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
91792080|NCT03036800|183461936|SUPERIORITY||Odds Ratio (OR)|2.44||||0.01|TWO_SIDED|95.0|1.23|4.84|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.84|1.23|0.010
91627804|NCT01183104|183147131|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91627805|NCT01183104|183147132|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.030
91627806|NCT01183104|183147133|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
91627807|NCT01183104|183147134|SUPERIORITY_OR_OTHER|||||||0.043|||||||ANCOVA|||||||0.043
91714099|NCT02864407|183319868|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
91714100|NCT02864407|183319869|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
91627808|NCT00323310|183147135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.46|<|0.0001|TWO_SIDED|95.0|1.1|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.1|<0.0001
91627809|NCT00323310|183147136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.45|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
91627810|NCT00323310|183147137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|1.42|<|0.0001|TWO_SIDED|95.0|0.4|0.9||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.9|0.4|<0.0001
91627811|NCT00323310|183147138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.56|<|0.001|TWO_SIDED|95.0|1.1|1.6||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.6|1.1|<0.001
91627812|NCT00323310|183147139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|1.49|<|0.001|TWO_SIDED|95.0|0.8|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.8|<0.001
91627813|NCT00323310|183147140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.4|0.8||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.8|0.4|<0.0001
91627814|NCT00323310|183147141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.57|<|0.0001|TWO_SIDED|95.0|1.0|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.0|<0.0001
91627815|NCT00323310|183147142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.49|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
91627816|NCT00323310|183147143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|1.54|<|0.0001|TWO_SIDED|95.0|0.6|1.1||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.1|0.6|<0.0001
91627817|NCT00937326|183147176|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.25 g/day in number of participants with any AE.||||0.4816
91627818|NCT00937326|183147176|SUPERIORITY|||||||0.1147||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.5 g/day in number of participants with any AE.||||0.1147
91627819|NCT00937326|183147176|SUPERIORITY|||||||1||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 1.0 g/day in number of participants with any AE.||||1.0000
91627820|NCT00937326|183147176|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 2.0 g/day in number of participants with any AE.||||0.4816
91664344|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-22.1|||<|0.001|TWO_SIDED|95.0|-31.4|-12.9|||Mixed Models Analysis|||2-hour postprandial after evening meal||-12.9|-31.4|< .001
91664345|NCT02597049|183222371|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.0|-7.4|||Mixed Models Analysis|||2-hour postprandial after evening meal||-7.4|-26.0|< .001
91714101|NCT02864407|183319870|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
91627821|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|168.4|||||TWO_SIDED|90.0|123.87|228.94|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.||228.94|123.87|
91627822|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|110.88|||||TWO_SIDED|90.0|88.18|139.43|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.||139.43|88.18|
91627823|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|133.11|||||TWO_SIDED|90.0|100.55|176.21|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.||176.21|100.55|
91627824|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Other|94.3|||||TWO_SIDED|90.0|70.31|126.48|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.||126.48|70.31|
91627825|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|141.63|||||TWO_SIDED|90.0|111.2|180.39|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.||180.39|111.20|
91664346|NCT02597049|183222372|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||ANCOVA|||Treatment-regimen Estimand||-0.1|-2.3|0.032
91714102|NCT02864407|183319871|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
91482564|NCT04090957|182838779|SUPERIORITY||Least square mean difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.05|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-0.05|-0.10|<0.0001
91482565|NCT04090957|182838779|SUPERIORITY||Least square mean difference|-0.03||||0.0898|TWO_SIDED|95.0|-0.06|0.0|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||0.00|-0.06|0.0898
91482566|NCT04090957|182838779|SUPERIORITY||Least square mean difference|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.04|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||-0.04|-0.10|<0.0001
91482567|NCT04090957|182838780|SUPERIORITY||Least square mean difference|-0.13|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.08|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-0.08|-0.18|<0.0001
91482568|NCT04090957|182838780|SUPERIORITY||Least square mean difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.09|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-0.09|-0.18|<0.0001
91627826|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.46|||||TWO_SIDED|90.0|85.56|153.11|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.||153.11|85.56|
91482569|NCT04090957|182838780|SUPERIORITY||Least square mean difference|-0.17|||<|0.0001|TWO_SIDED|95.0|-0.23|-0.11|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-0.11|-0.23|<0.0001
91482570|NCT04090957|182838780|SUPERIORITY||Least square mean difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.2|-0.08|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||-0.08|-0.20|<0.0001
91482571|NCT04090957|182838781|SUPERIORITY||Least square mean difference|-6.22||||0.022|TWO_SIDED|95.0|-11.67|-0.78|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||-0.78|-11.67|0.0220
91627827|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|167.09|||||TWO_SIDED|90.0|120.73|231.25|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.||231.25|120.73|
91664347|NCT02597049|183222372|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.273|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||Treatment-regimen Estimand||0.5|-1.7|0.273
91664348|NCT02597049|183222372|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.023|TWO_SIDED|95.0|-2.4|-0.2|||ANCOVA|||Efficacy Estimand||-0.2|-2.4|0.023
91664349|NCT02597049|183222372|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.32|TWO_SIDED|95.0|-1.7|0.6|||ANCOVA|||Efficacy Estimand||0.6|-1.7|0.320
91664350|NCT04050735|183222377|OTHER|None of the above apply to this study|F-test|1.125||||0.343|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed model testing the three-way interaction of HIV serostatus (positive/negative), beverage condition (alcohol/placebo), and time (hour 0, 1, 2, 3).||||.343
91664351|NCT04050735|183222378|OTHER|None of the above options apply to this study.|F-test|3.236||||0.026|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed model testing the three-way interaction of HIV serostatus (positive/negative), beverage condition (alcohol/placebo), and time (hour 0, 1, 2, 3).||||.026
91664352|NCT04050735|183222379|OTHER|The above categories do not apply to this type of study.||||||0.987||||||The p-value for the interaction of HIV serostatus by beverage condition.|ANOVA|||Test of group by condition interaction on choline.||||.987
91664353|NCT04050735|183222379|OTHER|The above types of tests do not apply to this study.||||||0.836|||||||ANOVA|||Test of group by condition interaction on summed peak of glutamate plus glutamine||||.836
91792081|NCT03036800|183461937|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.14|12.39|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.39|2.14|<0.001
91482572|NCT04090957|182838781|SUPERIORITY||Least square mean difference|-11.61|||<|0.0001|TWO_SIDED|95.0|-17.02|-6.21|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||-6.21|-17.02|<0.0001
91627828|NCT00937326|183147200|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|117.73|||||TWO_SIDED|90.0|85.14|162.79|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.||162.79|85.14|
91627829|NCT00937326|183147201|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|122.22|||||TWO_SIDED|90.0|86.94|171.8|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.||171.80|86.94|
91627830|NCT00937326|183147201|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|94.45|||||TWO_SIDED|90.0|69.07|129.16|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.||129.16|69.07|
91627831|NCT00937326|183147201|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.79|||||TWO_SIDED|90.0|91.54|143.95|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.||143.95|91.54|
91627832|NCT00937326|183147201|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|120.3|||||TWO_SIDED|90.0|88.66|163.23|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.||163.23|88.66|
91627833|NCT00937326|183147206|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.||||0.997
91627834|NCT00937326|183147206|SUPERIORITY|||||||0.581||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.||||0.581
91627835|NCT00937326|183147206|SUPERIORITY|||||||0.987||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.||||0.987
91627836|NCT00937326|183147206|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.||||0.999
91627837|NCT00937326|183147206|SUPERIORITY|||||||0.85||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.||||0.850
91627838|NCT00937326|183147206|SUPERIORITY|||||||0.843||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.||||0.843
91664354|NCT04050735|183222380|OTHER|The above types of tests do not apply to this study.||||||0.846|||||||ANOVA|||Test of group by condition interaction on fractional anisotropy (FA).||||.846
91664355|NCT04050735|183222381|OTHER|The above types of tests do not apply to this study.||||||0.894|||||||ANOVA|||Test of interaction of group by beverage condition.||||.894
91664356|NCT01248728|183222407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
91664357|NCT01248728|183222408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
91714103|NCT02864407|183319872|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
91482573|NCT04090957|182838781|SUPERIORITY||Least square mean difference|-15.93|||<|0.0001|TWO_SIDED|95.0|-22.7|-9.17|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||-9.17|-22.70|<0.0001
91627839|NCT00937326|183147206|SUPERIORITY|||||||0.961||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.||||0.961
91627840|NCT00937326|183147206|SUPERIORITY|||||||0.939||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.||||0.939
91627841|NCT00937326|183147206|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.||||0.966
91627842|NCT00937326|183147206|SUPERIORITY|||||||0.075||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.||||0.075
91627843|NCT00937326|183147206|SUPERIORITY|||||||0.7||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.||||0.700
91627844|NCT00937326|183147206|SUPERIORITY|||||||0.732||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.||||0.732
91664358|NCT01248728|183222410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91714104|NCT02864407|183319873|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
91482574|NCT04090957|182838781|SUPERIORITY||Least square mean difference|-13.68|||<|0.0001|TWO_SIDED|95.0|-20.63|-6.74|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||-6.74|-20.63|<0.0001
91482575|NCT04090957|182838782|SUPERIORITY||Least square mean difference|1.86||||0.7531|TWO_SIDED|95.0|-4.69|8.42|||Linear Mixed Model for Repeated Measures|||1\_Week 12 Estetrol 15 mg vs Placebo||8.42|-4.69|0.7531
91627845|NCT00937326|183147206|SUPERIORITY|||||||0.552||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.||||0.552
91714105|NCT02864407|183319874|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
91627846|NCT00937326|183147206|SUPERIORITY|||||||0.196||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.||||0.196
91627847|NCT00937326|183147206|SUPERIORITY|||||||0.393||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.||||0.393
91627848|NCT00937326|183147206|SUPERIORITY|||||||0.775||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.||||0.775
91627849|NCT00937326|183147206|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.||||1.000
91664359|NCT01248728|183222411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Regression, Linear|||||||0.6
91714106|NCT02864407|183319875|OTHER||||||<|0.0001||||||p-value for difference of 52±2 weeks versus Baseline.|Paired t-test|||||||<0.0001
91482576|NCT04090957|182838782|SUPERIORITY||Least square mean difference|-2.7||||0.5548|TWO_SIDED|95.0|-9.18|3.79|||Linear Mixed Model for Repeated Measures|||2\_Week 12 Estetrol 20 mg vs Placebo||3.79|-9.18|0.5548
91664360|NCT01838681|183222420|SUPERIORITY||Odds Ratio (OR)|0.83||||0.2641|TWO_SIDED|95.0|0.6|1.15|||Regression, Logistic|Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used||||1.15|0.60|0.2641
91664361|NCT00902538|183222449|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||ANCOVA|||||||0.1187
91664362|NCT00902538|183222449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91664363|NCT00902538|183222450|SUPERIORITY_OR_OTHER|||||||0.0425||95.0|||||ANCOVA|||||||0.0425
91664364|NCT00902538|183222450|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91664365|NCT00902538|183222451|SUPERIORITY_OR_OTHER|||||||0.1939||95.0|||||Cochran-Mantel-Haenszel|||||||0.1939
91714107|NCT02864407|183319876|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
91714108|NCT02864407|183319877|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
91627850|NCT00937326|183147206|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.||||0.989
91714109|NCT02686164|183319890|OTHER||Geometric Mean Ratio|0.914|||||TWO_SIDED|90.0|0.85|0.983||||||AUC(0-24) of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam Versus (vs.) Cycle 1 Day -3, Midazolam||0.983|0.850|
91714110|NCT02686164|183319890|OTHER||Geometric Mean Ratio|1.148|||||TWO_SIDED|90.0|0.938|1.404||||||AUC(0-24) of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.404|0.938|
91482577|NCT04090957|182838782|SUPERIORITY||Least square mean difference|6.81||||0.117|TWO_SIDED|95.0|-1.36|14.99|||Linear Mixed Model for Repeated Measures|||3\_Week 52 Estetrol 15 mg vs Placebo||14.99|-1.36|0.1170
91482578|NCT04090957|182838782|SUPERIORITY||Least square mean difference|-1.55||||0.8885|TWO_SIDED|95.0|-9.97|6.87|||Linear Mixed Model for Repeated Measures|||4\_Week 52 Estetrol 20 mg vs Placebo||6.87|-9.97|0.8885
91482579|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.45||||0.0781|TWO_SIDED|95.0|-0.95|0.04|||Mixed Model for Repeated Measures|||1\_Week 12, Vasomotor Domain, E4 15 mg vs Placebo||0.04|-0.95|0.0781
91627851|NCT00937326|183147206|SUPERIORITY|||||||0.603||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.||||0.603
91627852|NCT00937326|183147206|SUPERIORITY|||||||0.108||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.||||0.108
91627853|NCT00937326|183147207|SUPERIORITY|||||||0.525||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.||||0.525
91627854|NCT00937326|183147207|SUPERIORITY|||||||0.818||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.||||0.818
91627855|NCT00937326|183147207|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.||||0.999
91627856|NCT00937326|183147207|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.||||0.809
91627857|NCT00937326|183147207|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.||||0.993
91627858|NCT00937326|183147207|SUPERIORITY|||||||0.954||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.||||0.954
91627859|NCT00937326|183147207|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.||||1.000
91627860|NCT00937326|183147207|SUPERIORITY|||||||0.344||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.||||0.344
91627861|NCT00937326|183147207|SUPERIORITY|||||||0.968||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.||||0.968
91714111|NCT02686164|183319890|OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.94|1.335||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.335|0.940|
91482580|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.78||||0.0011|TWO_SIDED|95.0|-1.27|-0.28|||Mixed Model for Repeated Measures|||2\_Week 12, Vasomotor Domain, E4 20 mg vs Placebo||-0.28|-1.27|0.0011
91482581|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.76||||0.0085|TWO_SIDED|95.0|-1.35|-0.17|||Linear Mixed Model for Repeated Measures|||3\_Week 52, Vasomotor Domain, E4 15 mg vs Placebo||-0.17|-1.35|0.0085
91627862|NCT00937326|183147207|SUPERIORITY|||||||0.316||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.||||0.316
91627863|NCT00937326|183147207|SUPERIORITY|||||||0.984||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.||||0.984
91627864|NCT00937326|183147207|SUPERIORITY|||||||0.235||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.||||0.235
91664366|NCT00902538|183222451|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91664367|NCT00902538|183222452|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|||||||0.0009
91482582|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.75||||0.0127|TWO_SIDED|95.0|-1.35|-0.14|||Mixed Model for Repeated Measures|||4\_Week 52, Vasomotor Domain, E4 20 mg vs Placebo||-0.14|-1.35|0.0127
91664368|NCT00902538|183222452|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91664369|NCT00902538|183222453|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
91664370|NCT00902538|183222453|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91664371|NCT00902538|183222454|SUPERIORITY_OR_OTHER|||||||0.1611||95.0|||||ANCOVA|||||||0.1611
91664372|NCT00902538|183222455|SUPERIORITY_OR_OTHER|||||||0.0451||95.0|||||ANCOVA|||||||0.0451
91664373|NCT00902538|183222456|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||ANCOVA|||||||0.0412
91664374|NCT00902538|183222457|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||ANCOVA|||||||0.0253
91482583|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.12||||0.6211|TWO_SIDED|95.0|-0.46|0.21|||Mixed Model for Repeated Measures|||5\_Week 12, Psychosocial Domain, E4 15 mg vs Placebo||0.21|-0.46|0.6211
91664375|NCT00902538|183222458|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||||||0.0063
91482584|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.16||||0.4544|TWO_SIDED|95.0|-0.5|0.17|||Mixed Model for Repeated Measures|||6\_Week 12, Psychosocial Domain, E4 20 mg vs Placebo||0.17|-0.50|0.4544
91482585|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.32||||0.1349|TWO_SIDED|95.0|-0.72|0.08|||Mixed Model for Repeated Measures|||7\_Week 52, Psychosocial Domain, E4 15 mg vs Placebo||0.08|-0.72|0.1349
91482586|NCT04090957|182838783|SUPERIORITY||Least square mean difference|0.08||||0.8875|TWO_SIDED|95.0|-0.33|0.49|||Mixed Model for Repeated Measures|||8\_Week 52, Psychosocial Domain, E4 20 mg vs Placebo||0.49|-0.33|0.8875
91664376|NCT03215706|183222485|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.69||||0.0006|TWO_SIDED|95.0|0.56|0.86|||Log-rank test stratified|||||0.86|0.56|0.0006
91482587|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.08||||0.8109|TWO_SIDED|95.0|-0.4|0.24|||Mixed Model for Repeated Measures|||9\_Week 12, Physical Domain, E4 15 mg vs Placebo||0.24|-0.40|0.8109
91627865|NCT00937326|183147207|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.||||1.000
91664377|NCT03215706|183222486|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.59|0.82|||Log-rank test stratified|||||0.82|0.59|
91664378|NCT03215706|183222487|SUPERIORITY|Treatment A over Treatment B|Odds Ratio (OR)|12.7|||||TWO_SIDED|95.0|6.0|19.4|||Mantel Haenszel|||||19.4|6.0|
91664379|NCT03215706|183222493|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.87|||Stratified Cox proportional hazard model|||||0.87|0.63|
91664380|NCT02433977|183222497|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664381|NCT02433977|183222498|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664382|NCT02433977|183222499|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664383|NCT02433977|183222500|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664384|NCT02433977|183222502|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664385|NCT02433977|183222504|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664386|NCT02433977|183222505|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664387|NCT02433977|183222506|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
91664388|NCT03247686|183222519|SUPERIORITY|||||||4.96e-05|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 All||||0.0000496
91664389|NCT03247686|183222519|SUPERIORITY|||||||1.03e-05|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 All||||0.0000103
91664390|NCT03247686|183222519|SUPERIORITY|||||||0.0004398|||||||t-test, 2 sided|||Module M5.12 Placebo versus RSLV-132 All||||0.0004398
91664391|NCT03247686|183222519|SUPERIORITY|||||||6.8e-06|||||||t-test, 2 sided|||Module 1.2 Placebo versus RSLV-132 Responders||||0.0000068
91664392|NCT03247686|183222519|SUPERIORITY|||||||2e-07|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Responders||||0.0000002
91664393|NCT03247686|183222519|SUPERIORITY|||||||9.26e-05|||||||t-test, 2 sided|||Module 5.12 Placebo versus RSLV-132 Responders||||0.0000926
91664394|NCT03247686|183222519|SUPERIORITY|||||||0.001545|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 Non-responders||||0.0015450
91664395|NCT03247686|183222519|SUPERIORITY|||||||0.0004632|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Non-responders||||0.0004632
91664396|NCT03247686|183222519|SUPERIORITY|||||||0.009696|||||||t-test, 2 sided|||Module M5.12||||0.0096960
91664397|NCT03247686|183222520|EQUIVALENCE|Two sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-2.5||||0.18|TWO_SIDED|95.0|-6.34|1.34|||t-test, 2 sided|||Mean difference in change from baseline (95% CI)||1.34|-6.34|0.180
91627866|NCT00937326|183147207|SUPERIORITY|||||||0.656||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.||||0.656
91627867|NCT00937326|183147207|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.||||0.994
91627868|NCT00937326|183147207|SUPERIORITY|||||||0.285||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.||||0.285
91627869|NCT00937326|183147207|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.||||0.992
91627870|NCT00937326|183147207|SUPERIORITY|||||||0.822||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.||||0.822
91627871|NCT00937326|183147207|SUPERIORITY|||||||0.538||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.||||0.538
91627872|NCT00937326|183147207|SUPERIORITY|||||||0.907||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.||||0.907
91627873|NCT00937326|183147208|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.||||0.999
91627874|NCT00937326|183147208|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.||||0.982
91627875|NCT00937326|183147208|SUPERIORITY|||||||0.677||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.||||0.677
91627876|NCT00937326|183147208|SUPERIORITY|||||||0.688||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.||||0.688
91664398|NCT02302716|183222521|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week HbA1c level for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|-0.04||||0.693|TWO_SIDED|95.0|-0.22|0.15|||Mixed Models Analysis|||||0.15|-0.22|0.693
91664399|NCT00830258|183222532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|105.76||||||90.0|98.17|113.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||113.93|98.17|
91664400|NCT00830258|183222533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.45||||||90.0|104.31|116.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116.96|104.31|
91664401|NCT00830258|183222534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.61||||||90.0|104.39|117.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117.20|104.39|
91664402|NCT01127087|183222552|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the RYGB Calcium oxalate (CaOx) Stone Formers arm.||||0.027
91664403|NCT01127087|183222552|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.14
91664404|NCT01127087|183222553|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the RYGB CaOx Stone Formers arm.||||0.018
91664405|NCT01127087|183222553|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.06
91627877|NCT00937326|183147208|SUPERIORITY|||||||0.903||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.||||0.903
91627878|NCT00937326|183147208|SUPERIORITY|||||||0.945||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.||||0.945
91627879|NCT00937326|183147208|SUPERIORITY|||||||0.949||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.||||0.949
91627880|NCT00937326|183147208|SUPERIORITY|||||||0.924||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.||||0.924
91664406|NCT02997176|183222558|OTHER|Bioequivalence|Percent Ratio of Geometric Means|142.19|||||TWO_SIDED|90.0|79.92|252.98||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||252.98|79.92|
91664407|NCT02997176|183222558|OTHER|Bioequivalence|Percent Ratio of Geometric Means|110.54|||||TWO_SIDED|90.0|54.58|223.85||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||223.85|54.58|
91627881|NCT00937326|183147208|SUPERIORITY|||||||0.394||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.||||0.394
91627882|NCT00937326|183147208|SUPERIORITY|||||||0.687||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.||||0.687
91627883|NCT00937326|183147208|SUPERIORITY|||||||0.568||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.||||0.568
91627884|NCT00937326|183147208|SUPERIORITY|||||||0.486||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.||||0.486
91627885|NCT00937326|183147208|SUPERIORITY|||||||0.973||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.||||0.973
91627886|NCT00937326|183147208|SUPERIORITY|||||||0.739||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.||||0.739
91627887|NCT00937326|183147208|SUPERIORITY|||||||0.731||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.||||0.731
91627888|NCT00937326|183147208|SUPERIORITY|||||||0.991||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.||||0.991
91627889|NCT00937326|183147208|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.||||0.994
91627890|NCT00937326|183147208|SUPERIORITY|||||||0.963||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.||||0.963
91627891|NCT00937326|183147208|SUPERIORITY|||||||0.929||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.||||0.929
91664408|NCT02997176|183222559|OTHER|Bioequivalence|Percent Ratio of Geometric Means|109.76|||||TWO_SIDED|90.0|70.93|169.84||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||169.84|70.93|
91627892|NCT00937326|183147208|SUPERIORITY|||||||0.97||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.||||0.970
91482588|NCT04090957|182838783|SUPERIORITY||Least square mean difference|0.12||||0.6184|TWO_SIDED|95.0|-0.2|0.44|||Mixed Model for Repeated Measures|||10\_Week 12, Physical Domain, E4 20 mg vs Placebo||0.44|-0.20|0.6184
91482589|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.25||||0.2548|TWO_SIDED|95.0|-0.63|0.13|||Mixed Model for Repeated Measures|||11\_Week 52, Physical Domain, E4 15 mg vs Placebo||0.13|-0.63|0.2548
91482590|NCT04090957|182838783|SUPERIORITY||Least square mean difference|0.09||||0.8282|TWO_SIDED|95.0|-0.3|0.48|||Mixed Model for Repeated Measures|||12\_Week 52, Physical Domain, E4 20 mg vs Placebo||0.48|-0.30|0.8282
91482591|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.27||||0.3299|TWO_SIDED|95.0|-0.75|0.2|||Mixed Model for Repeated Measures|||13\_Week 12, Sexual Domain, E4 15 mg vs Placebo||0.20|-0.75|0.3299
91482592|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.22||||0.48|TWO_SIDED|95.0|-0.69|0.25|||Mixed Model for Repeated Measures|||14\_Week 12, Sexual Domain, E4 20 mg vs Placebo||0.25|-0.69|0.4800
91482593|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.39||||0.2133|TWO_SIDED|95.0|-0.96|0.17|||Mixed Model for Repeated Measures|||15\_Week 52, Sexual Domain, E4 15 mg vs Placebo||0.17|-0.96|0.2133
91482594|NCT04090957|182838783|SUPERIORITY||Least square mean difference|0.14||||0.8116|TWO_SIDED|95.0|-0.44|0.73|||Mixed Model for Repeated Measures|||16\_Week 52, Sexual Domain, E4 20 mg vs Placebo||0.73|-0.44|0.8116
91482595|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.23||||0.1853|TWO_SIDED|95.0|-0.53|0.08|||Mixed Model for Repeated Measures|||17\_Week 12, Total MENQOL, E4 15 mg vs Placebo||0.08|-0.53|0.1853
91482596|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.26||||0.1176|TWO_SIDED|95.0|-0.57|0.05|||Mixed Model for Repeated Measures|||18\_Week 12, Total MENQOL, E4 20 mg vs Placebo||0.05|-0.57|0.1176
91482597|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.43||||0.0176|TWO_SIDED|95.0|-0.79|-0.06|||Mixed Model for Repeated Measures|||19\_Week 52, Total MENQOL, E4 15 mg vs Placebo||-0.06|-0.79|0.0176
91482598|NCT04090957|182838783|SUPERIORITY||Least square mean difference|-0.12||||0.6909|TWO_SIDED|95.0|-0.49|0.25|||Mixed Model for Repeated Measures|||20\_Week 52, Total MENQOL, E4 20 mg vs Placebo||0.25|-0.49|0.6909
91482599|NCT02882074|182838834|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.158|TWO_SIDED|95.0|-0.11|0.64|||Regression, Linear|||||0.64|-0.11|0.158
91627893|NCT00937326|183147209|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.||||0.989
91627894|NCT00937326|183147209|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.||||0.989
91664409|NCT02997176|183222559|OTHER|Bioequivalence|Percent Ratio of Geometric Means|131.67|||||TWO_SIDED|90.0|77.14|224.74||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||224.74|77.14|
91664410|NCT02997176|183222560|OTHER|Bioequivalence|Percent Ratio of Geometric Means|149.39|||||TWO_SIDED|90.0|91.49|243.93||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||243.93|91.49|
91482600|NCT02882074|182838835|SUPERIORITY||Ratio of geometric means|0.86||||0.388|TWO_SIDED|97.5|0.57|1.28||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Syndecan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.28|0.57|0.388
91482601|NCT02882074|182838836|SUPERIORITY||Ratio of geometric means|1.19||||0.257|TWO_SIDED|97.5|0.84|1.68||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Endocan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.68|0.84|0.257
91482602|NCT02882074|182838837|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.003|TWO_SIDED|95.0|0.23|1.01|||Regression, Linear|||||1.01|0.23|0.003
91482603|NCT01068652|182838920|NON_INFERIORITY_OR_EQUIVALENCE|The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 \<0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens.|Mean Difference (Final Values)|0.11||||0.3406||95.0|-0.12|0.34|||ANCOVA|||To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated.||0.34|-0.12|0.3406
91482604|NCT00417482|182838939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.94||||0.02|TWO_SIDED|95.0|1.09|3.45|||Stratified Cox analysis|||The primary hypothesis of a difference in survival functions between the initial Phase B placebo (Arm 3) and risperidone continuation (Arms 1+2) conditions was tested in the primary analysis using the stratified Cox analysis. For descriptive purposes, the overall rate of relapse was assessed as the number of follow-up or for secondary interpretative support, as a simple proportion of patients entering a 16-week period.||3.45|1.09|0.02
91525374|NCT02277743|182926173|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.18|35.17||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||35.17|20.18|< 0.0001
91627895|NCT00937326|183147209|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.||||0.982
91482605|NCT00417482|182838940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.88||||0.02|TWO_SIDED|95.0|1.08|21.98|||stratified cox analyses|||Similar analyses were used to test the secondary hypothesis in the relapse risk in weeks 17 to 32 of Phase B between the patients who continued to receive risperidone (Arm 1) \& the patients who discontinued risperidone at week 16 \& were switched to placebo (Arm 2). Patients who died \& those in whom a relapse was considered to be imminent before they were dropped out in Phase B were classified as having relapse.||21.98|1.08|0.02
91482606|NCT00417482|182838941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.36||0.08|TWO_SIDED|95.0|-0.08|1.35|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.||1.35|-0.08|0.08
91482607|NCT00417482|182838942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.49||0.94||95.0|-1.01|0.93|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.||0.93|-1.01|0.94
91482608|NCT00417482|182838943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.48||0.26|TWO_SIDED|95.0|-1.5|0.41|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.||0.41|-1.50|0.26
91482609|NCT00417482|182838944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.5|0.07|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.||0.07|-0.50|0.13
91482610|NCT00417482|182838945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.43||0.149|TWO_SIDED|95.0|-1.47|0.23|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.||0.23|-1.47|0.149
91482611|NCT00417482|182838946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.69||0.81|TWO_SIDED|95.0|-3.77|2.95|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.||2.95|-3.77|0.81
91482612|NCT00107952|182838980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|-1.6||||||95.0|-8.6|5.5||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||5.5|-8.6|
91482613|NCT00251004|182838982|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|2.2||||0.001|TWO_SIDED|95.0|-2.9|7.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||7.3|-2.9|0.001
91482614|NCT00251004|182838982|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in Percentage|0.3|||<|0.001|TWO_SIDED|95.0|-4.6|5.2||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||5.2|-4.6|<0.001
91482615|NCT00251004|182838983|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|1.8||||0.014|TWO_SIDED|95.0|-5.5|9.1||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z - test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is \<10%.||9.1|-5.5|0.014
91627896|NCT00937326|183147209|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.||||0.999
91714112|NCT02686164|183319890|OTHER||Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|1.057|1.36||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady-state) + Midazolam vs.Cycle 1 Day -3, Midazolam||1.360|1.057|
91482616|NCT00251004|182838983|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|-3.8|||<|0.001|TWO_SIDED|95.0|-10.8|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is \<10%.||3.3|-10.8|<0.001
91482617|NCT00251004|182838984|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|2.42|||<|0.001|TWO_SIDED|95.0|-1.6|6.5||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||6.5|-1.6|<0.001
91482618|NCT00251004|182838984|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-4.9|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||3.3|-4.9|<0.001
91482619|NCT01569464|182838991|SUPERIORITY_OR_OTHER||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|1.36||0.8451|TWO_SIDED|95.0|-2.96|2.42||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||2.42|-2.96|0.8451
91627897|NCT00937326|183147209|SUPERIORITY|||||||0.685||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.||||0.685
91627898|NCT00937326|183147209|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.||||0.999
91627899|NCT00937326|183147209|SUPERIORITY|||||||0.971||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.||||0.971
91627900|NCT00937326|183147209|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.||||1.000
91627901|NCT00937326|183147209|SUPERIORITY|||||||0.405||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.||||0.405
91627902|NCT00937326|183147209|SUPERIORITY|||||||0.975||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.||||0.975
91627903|NCT00937326|183147209|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.||||0.999
91714113|NCT02686164|183319891|OTHER||Geometric Mean Ratio|0.862|||||TWO_SIDED|90.0|0.753|0.988||||||Cmax of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||0.988|0.753|
91482620|NCT01569464|182838992|SUPERIORITY_OR_OTHER||LS Mean|0.07|STANDARD_ERROR_OF_MEAN|0.34||0.8336|TWO_SIDED|95.0|-0.61|0.75||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||0.75|-0.61|0.8336
91627904|NCT00937326|183147209|SUPERIORITY|||||||0.629||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.||||0.629
91627905|NCT00937326|183147209|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.||||0.982
91627906|NCT00937326|183147209|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.||||0.982
91627907|NCT00937326|183147209|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.||||0.999
91627908|NCT00937326|183147209|SUPERIORITY|||||||0.874||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.||||0.874
91627909|NCT00937326|183147209|SUPERIORITY|||||||0.986||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.||||0.986
91482621|NCT02797054|182839024|OTHER|||||||0.069|||||||Chi-squared|||||||0.069
91482622|NCT02797054|182839025|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
91482623|NCT02797054|182839026|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
91482624|NCT02797054|182839027|OTHER|||||||0.895|||||||Chi-squared|||||||0.895
91627910|NCT00937326|183147209|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.||||0.997
91714114|NCT02686164|183319891|OTHER||Geometric Mean Ratio|1.027|||||TWO_SIDED|90.0|0.852|1.238||||||Cmax of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.238|0.852|
91482625|NCT02797054|182839028|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
91482626|NCT02797054|182839029|OTHER|||||||0.0015|||||||Chi-squared|||||||0.0015
91482627|NCT02797054|182839030|OTHER|||||||0.0056|||||||Chi-squared|||||||0.0056
91482628|NCT02797054|182839031|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
91482629|NCT02398409|182839051|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.117||0.8407|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||12 weeks compared to Baseline (BL)||||.8407
91482630|NCT02398409|182839051|SUPERIORITY||Median Difference (Net)|0.201|STANDARD_ERROR_OF_MEAN|0.12||0.015|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||At 6 months compared to BL||||.0150
91525375|NCT02277743|182926173|SUPERIORITY||difference in percentages|27.0|||<|0.0001|TWO_SIDED|95.0|19.47|34.44||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.44|19.47|< 0.0001
91627911|NCT00937326|183147209|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.||||1.000
91627912|NCT00937326|183147209|SUPERIORITY|||||||0.697||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.||||0.697
91627913|NCT00937326|183147210|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.||||1.000
91482631|NCT02398409|182839051|SUPERIORITY||Median Difference (Net)|0.114|STANDARD_ERROR_OF_MEAN|0.188||0.8373|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared BL||||.8373
91482632|NCT02398409|182839052|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.173||0.6445|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.6445
91482633|NCT02398409|182839052|SUPERIORITY||Median Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.158||0.5247|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.5247
91482634|NCT02398409|182839052|SUPERIORITY||Median Difference (Net)|0.1224|STANDARD_ERROR_OF_MEAN|0.187||0.9974|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.9974
91482635|NCT02398409|182839053|SUPERIORITY||Median Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.087||0.1918|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.1918
91482636|NCT02398409|182839053|SUPERIORITY||Median Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.078||0.9212|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.9212
91482637|NCT02398409|182839053|SUPERIORITY||Median Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.083||0.2358|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.2358
91482638|NCT02398409|182839054|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|0.168||0.1107|TWO_SIDED||||||Mixed Models Analysis|||12 weeks compared to BL||||.1107
91482639|NCT02398409|182839054|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.251|STANDARD_ERROR_OF_MEAN|0.211||0.0562|TWO_SIDED||||||Mixed Models Analysis|||6 months compared to BL||||.0562
91482640|NCT02398409|182839054|SUPERIORITY||Median Difference (Net)|0.226|STANDARD_ERROR_OF_MEAN|0.218||0.8579|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.8579
91482641|NCT00708071|182839069|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25||||0.143||95.0|-0.04|0.49|||McNemar||Difference in Proportions = SoC - FS VH S/D 4|||0.49|-0.04|0.143
91482642|NCT00708071|182839070|SUPERIORITY_OR_OTHER||Difference in proportions|0.31|||||TWO_SIDED|90.0|0.12|0.48|||||Difference in proportions = SoC - FS VH S/D 4|||0.48|0.12|
91482643|NCT00708071|182839071|SUPERIORITY_OR_OTHER||Difference in proportions|0.111|||||TWO_SIDED|90.0|-0.11|0.32|||||Difference in proportions = SoC - FS VH S/D 4|||0.32|-0.11|
91482644|NCT00708071|182839072|SUPERIORITY_OR_OTHER||Difference in proportions|-0.032|||||TWO_SIDED|90.0|-0.24|0.18|||||Difference in proportions = SoC - FS VH S/D 4|||0.18|-0.24|
91482645|NCT00708071|182839073|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|90.0|-0.21|0.21|||||Difference in proportions = SoC - FS VH S/D 4|||0.21|-0.21|
91482646|NCT00708071|182839074|SUPERIORITY_OR_OTHER||Difference in proportions|0.038|||||TWO_SIDED|90.0|-0.17|0.24|||||Difference in proportions = SoC - FS VH S/D 4|||0.24|-0.17|
91527797|NCT01678820|182930634|SUPERIORITY_OR_OTHER||Difference in least squares means|2.9||||0.469|TWO_SIDED|95.0|-5.0|10.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||10.7|-5.0|0.469
91627914|NCT00937326|183147210|SUPERIORITY|||||||0.812||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.||||0.812
91627915|NCT00937326|183147210|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.||||0.996
91627916|NCT00937326|183147210|SUPERIORITY|||||||0.198||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.||||0.198
91627917|NCT00937326|183147210|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.||||1.000
91627918|NCT00937326|183147210|SUPERIORITY|||||||0.358||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.||||0.358
91627919|NCT00937326|183147210|SUPERIORITY|||||||0.852||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.||||0.852
91482647|NCT00708071|182839075|SUPERIORITY_OR_OTHER|||||||0.645|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.645
91627920|NCT00937326|183147210|SUPERIORITY|||||||0.678||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.||||0.678
91627921|NCT00937326|183147210|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.||||1.000
91627922|NCT00937326|183147210|SUPERIORITY|||||||0.191||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.||||0.191
91627923|NCT00937326|183147210|SUPERIORITY|||||||0.805||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.||||0.805
91482648|NCT00708071|182839076|SUPERIORITY_OR_OTHER|||||||0.103||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.103
91482649|NCT00708071|182839077|SUPERIORITY_OR_OTHER|||||||0.833||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.833
91482650|NCT00708071|182839078|SUPERIORITY_OR_OTHER|||||||0.501||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.501
91627924|NCT00937326|183147210|SUPERIORITY|||||||0.96||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.||||0.960
91627925|NCT00937326|183147210|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.||||0.985
91627926|NCT00937326|183147210|SUPERIORITY|||||||0.733||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.||||0.733
91627927|NCT00937326|183147210|SUPERIORITY|||||||0.365||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.||||0.365
91664411|NCT02997176|183222560|OTHER|Bioequivalence|Percent Ratio of Geometric Means|111.04|||||TWO_SIDED|90.0|60.91|202.43||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||202.43|60.91|
91664412|NCT02997176|183222561|OTHER|Bioequivalence|Percent Ratio of Geometric Means|115.32|||||TWO_SIDED|90.0|77.95|170.6||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.6|77.95|
91482651|NCT00708071|182839079|SUPERIORITY_OR_OTHER|||||||0.247||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.247
91482652|NCT00708071|182839080|SUPERIORITY_OR_OTHER|||||||0.715||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.715
91482653|NCT00708071|182839082|SUPERIORITY_OR_OTHER|||||||0.754||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.754
91482654|NCT00708071|182839083|SUPERIORITY_OR_OTHER|||||||0.388||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.388
91525376|NCT02277743|182926174|SUPERIORITY||difference in percentages|36.6|||<|0.0001|TWO_SIDED|95.0|28.58|44.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||44.63|28.58|< 0.0001
91627928|NCT00937326|183147210|SUPERIORITY|||||||0.413||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.||||0.413
91627929|NCT00937326|183147210|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.||||0.765
91627930|NCT00937326|183147210|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.||||0.434
91627931|NCT00937326|183147210|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.||||0.184
91627932|NCT00937326|183147210|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.||||0.142
91714115|NCT02686164|183319891|OTHER||Geometric Mean Ratio|1.055|||||TWO_SIDED|90.0|0.879|1.268||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.268|0.879|
91482655|NCT00708071|182839084|SUPERIORITY_OR_OTHER|||||||0.234||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.234
91482656|NCT00708071|182839085|SUPERIORITY_OR_OTHER|||||||0.688||90.0||||Two-sided Wilcoxon paired sample tests|Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
91482657|NCT00708071|182839086|SUPERIORITY_OR_OTHER|||||||0.625||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.625
91482658|NCT00708071|182839087|SUPERIORITY_OR_OTHER|||||||0.688||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
91482659|NCT00708071|182839088|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
91482660|NCT00708071|182839089|SUPERIORITY_OR_OTHER|||||||0.521||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.521
91482661|NCT00708071|182839090|SUPERIORITY_OR_OTHER|||||||0.324||90.0||||alpha = 10%|Two-sided Wilcoxon paired sample tests|||||||0.324
91482662|NCT00708071|182839091|SUPERIORITY_OR_OTHER|||||||0.661||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.661
91627933|NCT00937326|183147210|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.||||0.999
91482663|NCT00708071|182839092|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
91482664|NCT00708071|182839093|SUPERIORITY_OR_OTHER|||||||0.699||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.699
91482665|NCT00708071|182839096|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||two-sided paired t-test|alpha = 5%||||||0.0010
91482666|NCT00708071|182839098|SUPERIORITY_OR_OTHER||Difference in proportions|0.182||||0.014|TWO_SIDED|95.0|0.04|0.34|||McNemar's test of paired proportions|Alpha = 5%|Difference in Proportions = (Number of SoC Participants with Hematoma/Seroma) - (Number of FS VH S/D 4 Participants with Hematoma/Seroma)|||0.34|0.04|0.014
91482667|NCT02140775|182839104|SUPERIORITY|||||||0.602|||||||Chi-squared|degrees of freedom = 1||A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.||||.602
91482668|NCT02140775|182839105|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-7.75|0.26|||t-test, 2 sided|||||0.26|-7.75|.066
91627934|NCT00937326|183147210|SUPERIORITY|||||||0.876||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.||||0.876
91627935|NCT00937326|183147210|SUPERIORITY|||||||0.756||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.||||0.756
91482669|NCT02140775|182839106|SUPERIORITY||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|7.68||0.674|TWO_SIDED|95.0|-18.59|12.09|||t-test, 2 sided|||||12.09|-18.59|.674
91482670|NCT01858636|182839137|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% upper confidence bound of 5.5%||Ho: Pt ≥ 8% Ha: Pt \< 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.||||0.0029
91482671|NCT01858636|182839138|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% lower confidence bound of 96.4%||Ho: St ≤ 90% Ha: St \> 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.||||<0.0001
91482672|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9538|TWO_SIDED|95.0|-0.075|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.071|-0.075|0.9538
91482673|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.8787|TWO_SIDED|95.0|-0.07|0.081||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.081|-0.070|0.8787
91482674|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002||||0.9544|TWO_SIDED|95.0|-0.062|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.066|-0.062|0.9544
91482675|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.955|TWO_SIDED|95.0|-0.106|0.112||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.112|-0.106|0.9550
91482676|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.8874|TWO_SIDED|95.0|-0.121|0.105||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.105|-0.121|0.8874
91627936|NCT00937326|183147210|SUPERIORITY|||||||0.983||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.||||0.983
91527798|NCT01678820|182930635|SUPERIORITY_OR_OTHER||Difference in least squares means|-24.4|||<|0.001|TWO_SIDED|95.0|-32.6|-16.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-16.3|-32.6|<0.001
91627937|NCT00937326|183147211|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.||||0.809
91627938|NCT00937326|183147211|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.||||1.000
91664413|NCT02997176|183222561|OTHER|Bioequivalence|Percent Ratio of Geometric Means|132.26|||||TWO_SIDED|90.0|81.87|213.67||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||213.67|81.87|
91664414|NCT02997176|183222562|OTHER|Bioequivalence|Percent Ratio of Geometric Means|124.4|||||TWO_SIDED|90.0|85.19|181.66||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||181.66|85.19|
91482677|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9595|TWO_SIDED|95.0|-0.099|0.095||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.095|-0.099|0.9595
91482678|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.3826|TWO_SIDED|95.0|-0.164|0.064||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.064|-0.164|0.3826
91482679|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.3912|TWO_SIDED|95.0|-0.164|0.065||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.065|-0.164|0.3912
91525377|NCT02277743|182926174|SUPERIORITY||difference in percentages|37.7|||<|0.0001|TWO_SIDED|95.0|29.7|45.77||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||45.77|29.70|< 0.0001
91627939|NCT00937326|183147211|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.||||0.989
91627940|NCT00937326|183147211|SUPERIORITY|||||||0.13||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.||||0.130
91627941|NCT00937326|183147211|SUPERIORITY|||||||0.87||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.||||0.870
91627942|NCT00937326|183147211|SUPERIORITY|||||||0.864||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.||||0.864
91627943|NCT00937326|183147211|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.||||0.997
91627944|NCT00937326|183147211|SUPERIORITY|||||||0.682||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.||||0.682
91664415|NCT02997176|183222562|OTHER|Bioequivalence|Percent Ratio of Geometric Means|113.42|||||TWO_SIDED|90.0|73.9|174.07||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||174.07|73.90|
91664416|NCT02997176|183222562|OTHER|Bioequivalence|Percent Ratio of Geometric Means|95.68|||||TWO_SIDED|90.0|67.9|134.83||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.83|67.90|
91664417|NCT02997176|183222563|OTHER|Bioequivalence|Percent Ratio of Geometric Means|99.31|||||TWO_SIDED|90.0|57.74|170.8||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.80|57.74|
91664418|NCT02997176|183222563|OTHER|Bioequivalence|Percent Ratio of Geometric Means|96.45|||||TWO_SIDED|90.0|52.22|178.14||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||178.14|52.22|
91664419|NCT02997176|183222563|OTHER|Bioequivalence|Percent Ratio of Geometric Means|64.05|||||TWO_SIDED|90.0|39.65|103.46||||||Cmax was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||103.46|39.65|
91664420|NCT02997176|183222566|OTHER|Bioequivalence|Percent Ratio of Geometric Means|118.47|||||TWO_SIDED|90.0|83.81|167.47||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||167.47|83.81|
91664421|NCT02997176|183222566|OTHER|Bioequivalence|Percent Ratio of Geometric Means|108.36|||||TWO_SIDED|90.0|73.25|160.3||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||160.30|73.25|
91664422|NCT02997176|183222566|OTHER|Bioequivalence|Percent Ratio of Geometric Means|117.84|||||TWO_SIDED|90.0|85.29|162.83||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||162.83|85.29|
91482680|NCT01227564|182839144|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.3221|TWO_SIDED|95.0|-0.149|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.050|-0.149|0.3221
91525378|NCT02277743|182926175|SUPERIORITY||difference in percentages|28.6|||<|0.0001|TWO_SIDED|95.0|20.64|36.52||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.52|20.64|< 0.0001
91525379|NCT02277743|182926175|SUPERIORITY||difference in percentages|28.0|||<|0.0001|TWO_SIDED|95.0|19.94|36.13||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.13|19.94|< 0.0001
91627945|NCT00937326|183147211|SUPERIORITY|||||||0.798||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.||||0.798
91627946|NCT00937326|183147211|SUPERIORITY|||||||0.73||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.||||0.730
91627947|NCT00937326|183147211|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
91627948|NCT00937326|183147211|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
91627949|NCT00937326|183147211|SUPERIORITY|||||||0.464||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.||||0.464
91627950|NCT00937326|183147211|SUPERIORITY|||||||0.634||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.||||0.634
91627951|NCT00937326|183147211|SUPERIORITY|||||||0.254||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.||||0.254
91664423|NCT02997176|183222567|OTHER|Bioequivalence|Percent Ratio of Geometric Means|94.58|||||TWO_SIDED|90.0|56.74|157.64||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||157.64|56.74|
91664424|NCT02997176|183222567|OTHER|Bioequivalence|Percent Ratio of Geometric Means|92.15|||||TWO_SIDED|90.0|51.69|164.26||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||164.26|51.69|
91714116|NCT02686164|183319891|OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.845|1.046||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.046|0.845|
91664425|NCT02997176|183222567|OTHER|Bioequivalence|Percent Ratio of Geometric Means|84.42|||||TWO_SIDED|90.0|53.14|134.1||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.10|53.14|
91664426|NCT05511935|183222590|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|3.69||0.64|TWO_SIDED|95.0|-5.57|9.06|||t-test, 2 sided|||||9.06|-5.57|0.64
91664427|NCT05511935|183222591|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.81||0.47|TWO_SIDED|95.0|-2.28|4.89|||t-test, 2 sided|||||4.89|-2.28|0.47
91664428|NCT05511935|183222592|SUPERIORITY||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|4.25||0.59|TWO_SIDED|95.0|-10.77|6.11|||t-test, 2 sided|||||6.11|-10.77|0.59
91664429|NCT05511935|183222593|SUPERIORITY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|5.53||0.77|TWO_SIDED|95.0|-12.61|9.38|||t-test, 2 sided|||||9.38|-12.61|0.77
91482681|NCT01227564|182839145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.18||||0.9384|TWO_SIDED|95.0|-1197.07|1293.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1293.42|-1197.07|0.9384
91482682|NCT01227564|182839145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|581.98||||0.3945|TWO_SIDED|95.0|-778.17|1942.13||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1942.13|-778.17|0.3945
91482683|NCT01227564|182839145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|315.08||||0.5773|TWO_SIDED|95.0|-812.15|1442.3||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1442.30|-812.15|0.5773
91482684|NCT01227564|182839146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.16||||0.5818|TWO_SIDED|95.0|-63.31|111.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||111.62|-63.31|0.5818
91525380|NCT02277743|182926176|SUPERIORITY||difference in percentages|29.6|||<|0.0001|TWO_SIDED|95.0|21.36|37.88||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||37.88|21.36|< 0.0001
91627952|NCT00937326|183147211|SUPERIORITY|||||||0.034||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.||||0.034
91627953|NCT00937326|183147211|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.||||0.765
91627954|NCT00937326|183147211|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.||||0.434
91714117|NCT02731300|183319900|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
91714118|NCT02731300|183319901|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
91714119|NCT02465164|183319902|OTHER|Wilcoxon rank-sum tests||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
91714120|NCT01481558|183319915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.01||0.55|TWO_SIDED|95.0|||||ANCOVA|||||||0.55
91482685|NCT01227564|182839146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.42||||0.0648|TWO_SIDED|95.0|-5.37|174.21||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||174.21|-5.37|0.0648
91482686|NCT01227564|182839146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.29||||0.1672|TWO_SIDED|95.0|-23.47|132.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||132.05|-23.47|0.1672
91482687|NCT01227564|182839147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.3106|TWO_SIDED|95.0|-9.94|3.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||3.22|-9.94|0.3106
91482688|NCT01227564|182839147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.1876|TWO_SIDED|95.0|-11.28|2.27||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||2.27|-11.28|0.1876
91482689|NCT01227564|182839147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||0.1742|TWO_SIDED|95.0|-9.66|1.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1.79|-9.66|0.1742
91482690|NCT01227564|182839148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.36||||0.4089|TWO_SIDED|95.0|-103.52|42.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||42.81|-103.52|0.4089
91664430|NCT05511935|183222594|SUPERIORITY||Mean Difference (Final Values)|-12.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.95|-6.47|||t-test, 2 sided|||||-6.47|-17.95|<0.001
91664431|NCT05511935|183222595|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|1.87||0.39|TWO_SIDED|95.0|-2.1|5.34|||t-test, 2 sided|||||5.34|-2.10|0.39
91482691|NCT01227564|182839148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.4||||0.0327|TWO_SIDED|95.0|-159.69|-7.11||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||-7.11|-159.69|0.0327
91482692|NCT01227564|182839148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.88||||0.0801|TWO_SIDED|95.0|-120.82|7.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||7.06|-120.82|0.0801
91627955|NCT00937326|183147211|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.||||0.184
91482693|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.78||||0.4892|TWO_SIDED|95.0|-37.15|76.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||76.71|-37.15|0.4892
91525381|NCT02277743|182926176|SUPERIORITY||difference in percentages|34.5|||<|0.0001|TWO_SIDED|95.0|26.08|42.84||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||42.84|26.08|< 0.0001
91627956|NCT00937326|183147211|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.||||0.142
91627957|NCT00937326|183147211|SUPERIORITY|||||||0.955||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.||||0.955
91627958|NCT00937326|183147211|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.||||0.985
91627959|NCT00937326|183147211|SUPERIORITY|||||||0.923||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.||||0.923
91627960|NCT00937326|183147211|SUPERIORITY|||||||0.883||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.||||0.883
91627961|NCT00937326|183147212|SUPERIORITY|||||||0.118||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.118
91664432|NCT05511935|183222596|SUPERIORITY||Mean Difference (Final Values)|-8.88|STANDARD_ERROR_OF_MEAN|2.84|<|0.01|TWO_SIDED|95.0|-14.52|-3.24|||t-test, 2 sided|||||-3.24|-14.52|<0.01
91525382|NCT02277743|182926177|SUPERIORITY||Least square (LS) mean difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.26|-17.52||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-17.52|-32.26|< 0.0001
91664433|NCT05511935|183222597|SUPERIORITY||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.06||0.49|TWO_SIDED|95.0|-10.9|5.23|||t-test, 2 sided|||||5.23|-10.90|0.49
91664434|NCT05511935|183222599|SUPERIORITY||Slope|7.71|STANDARD_ERROR_OF_MEAN|5.28||0.15|TWO_SIDED|95.0|-2.92|18.35|||Regression, Linear|||||18.35|-2.92|0.15
91664435|NCT05511935|183222600|SUPERIORITY||Slope|0.43|STANDARD_ERROR_OF_MEAN|4.19||0.92|TWO_SIDED|95.0|-8.13|8.99|||Regression, Linear|||||8.99|-8.13|0.92
91664436|NCT05511935|183222601|SUPERIORITY||Slope|7.66|STANDARD_ERROR_OF_MEAN|5.81||0.2|TWO_SIDED|95.0|-4.17|19.49|||Regression, Linear|||||19.49|-4.17|0.20
91664437|NCT05511935|183222602|SUPERIORITY||Slope|-9.29|STANDARD_ERROR_OF_MEAN|10.74||0.39|TWO_SIDED|95.0|-31.15|12.56|||Regression, Linear|||||12.56|-31.15|0.39
91691939|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3747||95.0|-0.04|0.12|||ANCOVA|||Pressing Spontaneous Pain Cycle 3||0.12|-0.04|0.3747
91714121|NCT03110133|183319925|SUPERIORITY|||||||0.0488|||||||Chi-squared|||||||0.0488
91627962|NCT00937326|183147212|SUPERIORITY|||||||0.119||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.119
91482694|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.06||||0.0915|TWO_SIDED|95.0|-8.51|110.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||110.63|-8.51|0.0915
91482695|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.42||||0.1638|TWO_SIDED|95.0|-14.88|85.72||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||85.72|-14.88|0.1638
91482696|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.29||||0.2006|TWO_SIDED|95.0|-54.28|252.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||252.86|-54.28|0.2006
91482697|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|225.63||||0.0067|TWO_SIDED|95.0|65.18|386.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||386.09|65.18|0.0067
91482698|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.46||||0.0204|TWO_SIDED|95.0|26.05|298.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||298.87|26.05|0.0204
91482699|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.13||||0.0766|TWO_SIDED|95.0|-12.63|240.89||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||240.89|-12.63|0.0766
91525383|NCT02277743|182926177|SUPERIORITY||LS mean difference|-22.8|||<|0.0001|TWO_SIDED|95.0|-30.33|-15.33||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-15.33|-30.33|< 0.0001
91627963|NCT00937326|183147212|SUPERIORITY|||||||0.293||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.293
91627964|NCT00937326|183147212|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.966
91627965|NCT00937326|183147213|SUPERIORITY|||||||0.94||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.940
91664438|NCT01662960|183222650|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|2.2||||0.443|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.443
91664439|NCT01662960|183222651|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|0.4||||0.8|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.80
91691940|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.163||95.0|-0.4|0.07|||ANCOVA|||Pressing Spontaneous Pain Cycle 4||0.07|-0.40|0.1630
91482700|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||413.41|40.23|0.0181
91664440|NCT01662960|183222652|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.002||||0.93|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.93
91482701|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||325.63|9.03|0.0387
91482702|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.84||||0.2277|TWO_SIDED|95.0|-69.29|284.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||284.97|-69.29|0.2277
91482703|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||413.41|40.23|0.0181
91482704|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||325.63|9.03|0.0387
91482705|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.92||||0.0747|TWO_SIDED|95.0|-14.62|298.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||298.45|-14.62|0.0747
91482706|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.4||||0.0151|TWO_SIDED|95.0|41.02|367.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||367.79|41.02|0.0151
91525384|NCT02277743|182926178|SUPERIORITY||difference in percentages|9.8||||0.0012|TWO_SIDED|95.0|3.95|15.71||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||15.71|3.95|0.0012
91527799|NCT01678820|182930635|SUPERIORITY_OR_OTHER||Difference in least squares means|0.3||||0.937|TWO_SIDED|95.0|-7.7|8.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||8.3|-7.7|0.937
91664441|NCT01662960|183222654|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|10.7||||0.28|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.28
91664442|NCT01662960|183222655|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.36||||0.86|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.86
91664443|NCT02727192|183222658|SUPERIORITY||Mean Difference (Net)|-0.6||||0.52|TWO_SIDED|95.0|-2.6|1.3||A two-sided significance level of 5% was considered to indicate statistical significance.|Regression, Linear|||||1.3|-2.6|0.520
91664444|NCT02727192|183222659|SUPERIORITY||Mean Difference (Net)|-0.9||||0.44|TWO_SIDED|95.0|-3.3|1.5|||Regression, Linear|||||1.5|-3.3|0.440
91482707|NCT01227564|182839149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.16||||0.0161|TWO_SIDED|95.0|33.25|313.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||313.07|33.25|0.0161
91482708|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.652||||0.1807|TWO_SIDED|95.0|-6.57|1.267||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.267|-6.570|0.1807
91482709|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.497||||0.8051|TWO_SIDED|95.0|-3.515|4.508||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||4.508|-3.515|0.8051
91482710|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.078||||0.5331|TWO_SIDED|95.0|-4.519|2.364||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||2.364|-4.519|0.5331
91482711|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.9274|TWO_SIDED|95.0|-3.99|3.641||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||3.641|-3.990|0.9274
91482712|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549||||0.0743|TWO_SIDED|95.0|-0.36|7.458||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||7.458|-0.360|0.0743
91482713|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.687||||0.3163|TWO_SIDED|95.0|-1.656|5.031||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||5.031|-1.656|0.3163
91627966|NCT00937326|183147213|SUPERIORITY|||||||0.197||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.197
91627967|NCT00937326|183147213|SUPERIORITY|||||||0.097||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.097
91627968|NCT00937326|183147213|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.404
91627969|NCT00937326|183147214|SUPERIORITY|||||||0.206||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.||||0.2060
91627970|NCT00937326|183147214|SUPERIORITY|||||||0.179||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.||||0.1790
91627971|NCT00937326|183147214|SUPERIORITY|||||||0.2741||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.2741
91627972|NCT00937326|183147214|SUPERIORITY|||||||0.6001||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.6001
91627973|NCT00937326|183147214|SUPERIORITY|||||||0.6711||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.||||0.6711
91714122|NCT03110133|183319928|SUPERIORITY|||||||0.0347|||||||Chi-squared|||||||0.0347
91627974|NCT00937326|183147214|OTHER|||||||0.1361||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.||||0.1361
91627975|NCT00937326|183147214|SUPERIORITY|||||||0.3369||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.3369
91627976|NCT00937326|183147214|SUPERIORITY|||||||0.0975||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.0975
91627977|NCT00937326|183147214|SUPERIORITY|||||||0.2184||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.||||0.2184
91627978|NCT00937326|183147214|SUPERIORITY|||||||0.1013||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.||||0.1013
91664445|NCT02727192|183222660|SUPERIORITY||Mean Difference (Net)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.9|||Regression, Linear|||||0.9|-2.1|0.410
91664446|NCT02727192|183222661|SUPERIORITY||Difference in Percentage of Participants|-9.3||||0.33|TWO_SIDED||||||Chi-squared|||||||0.33
91664447|NCT02727192|183222664|SUPERIORITY||Mean Difference (Net)|2.8||||0.058|TWO_SIDED|95.0|-0.1|5.8|||Regression, Linear|||Mental Component Summary score||5.8|-0.1|0.058
91525385|NCT02277743|182926178|SUPERIORITY||difference in percentages|17.3|||<|0.0001|TWO_SIDED|95.0|10.57|23.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||23.93|10.57|< 0.0001
91627979|NCT00937326|183147214|SUPERIORITY|||||||0.3286||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.3286
91627980|NCT00937326|183147214|SUPERIORITY|||||||0.5193||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.5193
91627981|NCT00937326|183147214|SUPERIORITY|||||||0.9788||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.||||0.9788
91627982|NCT00937326|183147214|SUPERIORITY|||||||0.1214||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.||||0.1214
91627983|NCT00937326|183147214|SUPERIORITY|||||||0.5751||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.5751
91627984|NCT00937326|183147214|SUPERIORITY|||||||0.2409||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.2409
91627985|NCT00937326|183147214|SUPERIORITY|||||||0.4829||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.||||0.4829
91627986|NCT00937326|183147214|SUPERIORITY|||||||0.7563||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.||||0.7563
91627987|NCT00937326|183147214|SUPERIORITY|||||||0.2907||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.2907
91627988|NCT00937326|183147214|SUPERIORITY|||||||0.7663||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.7663
91664448|NCT02727192|183222664|SUPERIORITY||Mean Difference (Net)|-2.1||||0.16|TWO_SIDED|95.0|-5.1|0.8|||Regression, Linear|||Physical Component Summary score||0.8|-5.1|0.160
91664449|NCT02727192|183222665|SUPERIORITY||Mean Difference (Net)|-0.9||||0.11|TWO_SIDED|95.0|-2.0|0.2|||Regression, Linear|||||0.2|-2.0|0.110
91664450|NCT02727192|183222667|SUPERIORITY||Mean Difference (Net)|0.1||||0.85|TWO_SIDED|95.0|-0.5|0.6|||Regression, Linear|||||0.6|-0.5|0.850
91664451|NCT02727192|183222669|SUPERIORITY||Median Difference (Net)|0.3||||0.65|TWO_SIDED|95.0|-1.0|1.6|||Regression, Linear|||||1.6|-1.0|0.650
91664452|NCT02727192|183222670|SUPERIORITY||Mean Difference (Net)|2.6||||0.006|TWO_SIDED|95.0|0.8|4.5|||Regression, Linear|||||4.5|0.8|0.006
91627989|NCT00937326|183147214|SUPERIORITY|||||||0.5825||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI||||0.5825
91627990|NCT00937326|183147214|SUPERIORITY|||||||0.322||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.||||0.3220
91627991|NCT00937326|183147214|SUPERIORITY|||||||0.0564||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.||||0.0564
91627992|NCT00937326|183147214|SUPERIORITY|||||||0.196||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.||||0.1960
91627993|NCT00937326|183147214|SUPERIORITY|||||||0.5997||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.||||0.5997
91627994|NCT00937326|183147214|SUPERIORITY|||||||0.9637||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.||||0.9637
91627995|NCT00937326|183147214|SUPERIORITY|||||||0.324||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.3240
91627996|NCT00937326|183147214|SUPERIORITY|||||||0.844||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.8440
91627997|NCT00937326|183147214|SUPERIORITY|||||||0.6483||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.||||0.6483
91664453|NCT02727192|183222671|SUPERIORITY||Median Difference (Net)|-31.4||||0.389|TWO_SIDED|95.0|-103.4|40.7|||Regression, Linear|||||40.7|-103.4|0.389
91664454|NCT02727192|183222674|SUPERIORITY||Mean Difference (Net)|0.1||||0.697|TWO_SIDED|95.0|-0.3|0.5|||Regression, Logistic|||||0.5|-0.3|0.697
91664455|NCT05497557|183222680|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.677|||||TWO_SIDED|90.0|0.547|0.839||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.839|0.547|
91714123|NCT01386606|183319991|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value of treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||||0.056
91482714|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.645||||0.519|TWO_SIDED|95.0|-6.721|3.43||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||3.430|-6.721|0.5190
91482715|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.758||||0.074|TWO_SIDED|95.0|-0.476|9.991||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||9.991|-0.476|0.0740
91482716|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.394||||0.4909|TWO_SIDED|95.0|-2.937|6.049||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||6.049|-2.937|0.4909
91482717|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.383||||0.9151|TWO_SIDED|95.0|-7.549|6.783||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||6.783|-7.549|0.9151
91482718|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.394||||0.1533|TWO_SIDED|95.0|-2.069|12.857||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||12.857|-2.069|0.1533
91482719|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.4371|TWO_SIDED|95.0|-3.904|8.915||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||8.915|-3.904|0.4371
91482720|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.6167|TWO_SIDED|95.0|-10.999|6.579||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.579|-10.999|0.6167
91482721|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11||||0.1844|TWO_SIDED|95.0|-2.993|15.212||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||15.212|-2.993|0.1844
91482722|NCT01227564|182839150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95||||0.6205|TWO_SIDED|95.0|-5.888|9.878||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.878|-5.888|0.6205
91627998|NCT00937326|183147214|SUPERIORITY|||||||0.6452||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.||||0.6452
91627999|NCT00937326|183147214|SUPERIORITY|||||||0.1253||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.1253
91628000|NCT00937326|183147214|SUPERIORITY|||||||0.2583||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.2583
91628001|NCT00937326|183147215|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.||||1.000
91628002|NCT00937326|183147215|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.||||1.000
91628003|NCT00937326|183147215|SUPERIORITY|||||||0.901||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.||||0.901
91628004|NCT00937326|183147215|SUPERIORITY|||||||0.155||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.||||0.155
91628005|NCT00937326|183147215|SUPERIORITY|||||||0.845||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.||||0.845
91482723|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.418||||0.1695|TWO_SIDED|95.0|-0.183|1.018||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.018|-0.183|0.1695
91525386|NCT02277743|182926179|SUPERIORITY||difference in percentages|6.1||||0.0097|TWO_SIDED|95.0|1.49|10.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.68|1.49|0.0097
91628006|NCT00937326|183147215|SUPERIORITY|||||||0.164||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.||||0.164
91628007|NCT00937326|183147215|SUPERIORITY|||||||0.699||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.||||0.699
91664456|NCT05497557|183222681|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.771|||||TWO_SIDED|90.0|0.628|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.628|
91664457|NCT05497557|183222682|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.766|||||TWO_SIDED|90.0|0.619|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.619|
91664458|NCT04590027|183222687|NON_INFERIORITY|power calculation was not recorded Definition of non inferiority: two point difference of pain score at the measurement times|||||<|0.05|||||||ANCOVA|To rule out confounders due to an age difference, the ANCOVA test was applied to compare the differences in pain scores age-unrelatedly.|||Fisher Yates Test to compare the requirement of resue medication|||<0.05
91527800|NCT01678820|182930636|SUPERIORITY_OR_OTHER||Difference in estimated means|-15.5||||0.068|TWO_SIDED|95.0|-32.2|1.2|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||1.2|-32.2|0.068
91628008|NCT00937326|183147215|SUPERIORITY|||||||0.313||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.||||0.313
91628009|NCT00937326|183147216|SUPERIORITY|||||||0.896||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.896
91664459|NCT04590027|183222688|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91664460|NCT00907907|183222741|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.97||||||90.0|80.25|110.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.04|80.25|
91714124|NCT01386606|183319991|SUPERIORITY_OR_OTHER||Regression Coefficient|-45.77||||0.436|TWO_SIDED|95.0|-143.5|51.98||P-value for Androxal 25 mg treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||51.98|-143.5|0.436
91482724|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147||||0.6331|TWO_SIDED|95.0|-0.465|0.759||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.759|-0.465|0.6331
91628010|NCT00937326|183147216|SUPERIORITY|||||||0.08||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.080
91482725|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.2907|TWO_SIDED|95.0|-0.247|0.812||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.812|-0.247|0.2907
91482726|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007||||0.9846|TWO_SIDED|95.0|-0.675|0.688||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.688|-0.675|0.9846
91482727|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.304||||0.3845|TWO_SIDED|95.0|-1.0|0.392||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.392|-1.000|0.3845
91482728|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149||||0.6204|TWO_SIDED|95.0|-0.748|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.450|-0.748|0.6204
91482729|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014||||0.981|TWO_SIDED|95.0|-1.221|1.192||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||1.192|-1.221|0.9810
91482730|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.796||||0.2034|TWO_SIDED|95.0|-2.034|0.443||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.443|-2.034|0.2034
91628011|NCT00937326|183147216|SUPERIORITY|||||||0.792||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.792
91628012|NCT00937326|183147216|SUPERIORITY|||||||0.645||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.645
91664461|NCT00907907|183222742|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|102.01||||||90.0|98.74|105.39|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.39|98.74|
91664462|NCT00907907|183222743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.91||||||90.0|95.99|103.98|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.98|95.99|
91664463|NCT00841542|183222780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.19||||||90.0|94.2|102.34|||||Bioequivalence is established when 90% Confidence Interval falls withing 80 - 125|||102.34|94.20|
91525387|NCT02277743|182926179|SUPERIORITY||difference in percentages|6.2||||0.0094|TWO_SIDED|95.0|1.45|10.86||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.86|1.45|0.0094
91525388|NCT02277743|182926180|SUPERIORITY||LS mean difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.236|-1.26||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.260|-2.236|< 0.0001
91525389|NCT02277743|182926180|SUPERIORITY||LS mean difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.189|-1.186||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.186|-2.189|< 0.0001
91525390|NCT02277743|182926181|SUPERIORITY||LS mean difference|-34.6|||<|0.0001|TWO_SIDED|95.0|-42.35|-26.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.88|-42.35|< 0.0001
91525391|NCT02277743|182926181|SUPERIORITY||LS mean difference|-34.4|||<|0.0001|TWO_SIDED|95.0|-42.17|-26.56||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.56|-42.17|< 0.0001
91525392|NCT02277743|182926182|SUPERIORITY||difference in percentages|44.2|||<|0.0001|TWO_SIDED|95.0|35.91|52.48||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||52.48|35.91|< 0.0001
91628013|NCT00937326|183147217|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.||||0.992
91482731|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.405||||0.4491|TWO_SIDED|95.0|-1.469|0.659||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.659|-1.469|0.4491
91482732|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255||||0.8074|TWO_SIDED|95.0|-1.827|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||2.337|-1.827|0.8074
91525393|NCT02277743|182926182|SUPERIORITY||difference in percentages|36.4|||<|0.0001|TWO_SIDED|95.0|27.9|44.96||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||44.96|27.90|< 0.0001
91525394|NCT02277743|182926183|SUPERIORITY||difference in percentages|28.1|||<|0.0001|TWO_SIDED|95.0|20.96|35.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||35.29|20.96|< 0.0001
91628014|NCT00937326|183147217|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.||||0.999
91628015|NCT00937326|183147217|SUPERIORITY|||||||0.548||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.||||0.548
91525395|NCT02277743|182926183|SUPERIORITY||difference in percentages|25.6|||<|0.0001|TWO_SIDED|95.0|18.51|32.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||32.68|18.51|< 0.0001
91525396|NCT02277743|182926184|SUPERIORITY||LS mean difference|-17.92|||<|0.0001|TWO_SIDED|95.0|-22.487|-13.353||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-13.353|-22.487|< 0.0001
91527801|NCT01678820|182930636|SUPERIORITY_OR_OTHER||Difference in estimated means|-10.3||||0.365|TWO_SIDED|95.0|-33.6|13.0|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||13.0|-33.6|0.365
91691941|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9568||95.0|-0.12|0.11|||ANOVA|||Pressing Spontaneous Pain Cycle 5||0.11|-0.12|0.9568
91691942|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9793||95.0|-0.13|0.13|||ANCOVA|||Pressing Spontaneous Pain Cycle 6||0.13|-0.13|0.9793
91691943|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.25||0.885||95.0|-0.54|0.47|||ANCOVA|||Pressing Spontaneous Pain Cycle 7||0.47|-0.54|0.8850
91628016|NCT00937326|183147217|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.||||0.989
91628017|NCT00937326|183147217|SUPERIORITY|||||||0.877||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.||||0.877
91628018|NCT00937326|183147217|SUPERIORITY|||||||0.887||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.||||0.887
91628019|NCT00937326|183147217|SUPERIORITY|||||||0.916||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.||||0.916
91628020|NCT00937326|183147217|SUPERIORITY|||||||0.86||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.||||0.860
91628021|NCT00937326|183147218|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.996
91525397|NCT02277743|182926184|SUPERIORITY||LS mean difference|-18.89|||<|0.0001|TWO_SIDED|95.0|-23.125|-14.65||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-14.650|-23.125|< 0.0001
91628022|NCT00937326|183147218|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.989
91628023|NCT00937326|183147218|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
91628024|NCT00937326|183147218|SUPERIORITY|||||||0.763||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.763
91628025|NCT00937326|183147219|SUPERIORITY|||||||0.81||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.810
91628026|NCT00937326|183147219|SUPERIORITY|||||||0.753||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.753
91628027|NCT00937326|183147219|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.404
91628028|NCT00937326|183147219|SUPERIORITY|||||||0.671||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.671
91525398|NCT02277743|182926185|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.79|-21.54||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-21.54|-35.79|< 0.0001
91664464|NCT00841542|183222781|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.86||||||90.0|93.38|104.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.66|93.38|
91664465|NCT00841542|183222782|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.22||||||90.0|93.87|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|93.87|
91691944|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2199||95.0|-0.17|0.7|||ANCOVA|||Pressing Spontaneous Pain Cycle 8||0.70|-0.17|0.2199
91482733|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.029||||0.3444|TWO_SIDED|95.0|-3.189|1.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.131|-3.189|0.3444
91482734|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387||||0.6772|TWO_SIDED|95.0|-2.239|1.464||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.464|-2.239|0.6772
91482735|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.652||||0.6325|TWO_SIDED|95.0|-2.063|3.367||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.367|-2.063|0.6325
91482736|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.5706|TWO_SIDED|95.0|-3.606|2.007||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.007|-3.606|0.5706
91628029|NCT00937326|183147219|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.||||1.000
91482737|NCT01227564|182839151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074||||0.9513|TWO_SIDED|95.0|-2.485|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.337|-2.485|0.9513
91482738|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.6054|TWO_SIDED|95.0|-0.074|0.043||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.043|-0.074|0.6054
91482739|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4087|TWO_SIDED|95.0|-0.035|0.084||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.084|-0.035|0.4087
91628030|NCT00937326|183147219|SUPERIORITY|||||||0.622||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.622
91628031|NCT00937326|183147219|SUPERIORITY|||||||0.332||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.332
91628032|NCT00937326|183147219|SUPERIORITY|||||||0.998||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.998
91628033|NCT00937326|183147220|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.994
91482740|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8518|TWO_SIDED|95.0|-0.046|0.056||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.056|-0.046|0.8518
91482741|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.4216|TWO_SIDED|95.0|-0.085|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.036|-0.085|0.4216
91482742|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.273|TWO_SIDED|95.0|-0.028|0.097||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.097|-0.028|0.2730
91482743|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8549|TWO_SIDED|95.0|-0.048|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.058|-0.048|0.8549
91482744|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.5847|TWO_SIDED|95.0|-0.12|0.068||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.068|-0.120|0.5847
91482745|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067||||0.174|TWO_SIDED|95.0|-0.03|0.163||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.163|-0.030|0.1740
91628034|NCT00937326|183147220|SUPERIORITY|||||||0.979||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.979
91628035|NCT00937326|183147220|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.993
91628036|NCT00937326|183147220|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
91628037|NCT03250624|183147263|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.632|TWO_SIDED|95.0|-1.46|0.89|||ANCOVA|||||0.89|-1.46|0.632
91628038|NCT00106249|183147270|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91628039|NCT00106249|183147271|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91628040|NCT00927576|183147302|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of the results showed a 95% chance of finding a p\<0.05 difference in 166 subjects and a 99% chance of finding a p \<0.05 difference in 230 subjects in comparison of Group 1 controls and sTBI patients.|Difference in z-score, sTBI vs. controls|2.04|||<|0.001|TWO_SIDED||||||ANOVA|for repeated measures with effect sizes (omega squared).||The null hypotheses was that the severe TBI group would not differ from the control group in SRT latencies.||||< 0.001
91628041|NCT00927576|183147302|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p \< 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group..|z-score difference between groups|-0.3||||0.5|TWO_SIDED|||||The P-value reflects the likelihood of detection a difference of the magnitude observed.|ANOVA|||The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group.||||.50
91628042|NCT01819506|183147340|SUPERIORITY|||||||0.912|||||||ANOVA|||||||0.912
91482746|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.6255|TWO_SIDED|95.0|-0.063|0.103||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.103|-0.063|0.6255
91482747|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.7658|TWO_SIDED|95.0|-0.177|0.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.131|-0.177|0.7658
91482748|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.3309|TWO_SIDED|95.0|-0.082|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.240|-0.082|0.3309
91482749|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.6872|TWO_SIDED|95.0|-0.11|0.166||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.166|-0.110|0.6872
91482750|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.9752|TWO_SIDED|95.0|-0.196|0.202||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.202|-0.196|0.9752
91482751|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143||||0.1715|TWO_SIDED|95.0|-0.064|0.349||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.349|-0.064|0.1715
91525399|NCT02277743|182926185|SUPERIORITY||LS mean difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.09|-20.87||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-20.87|-35.09|< 0.0001
91628043|NCT02420990|183147343|SUPERIORITY||Slope|-0.31|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
91628044|NCT02420990|183147343|SUPERIORITY||Slope|-0.67|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
91628045|NCT02420990|183147343|SUPERIORITY||Slope|0.05||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
91628046|NCT02420990|183147343|SUPERIORITY||Slope|0.56||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
91628047|NCT02420990|183147343|SUPERIORITY||Slope|-0.72||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
91628048|NCT02420990|183147344|SUPERIORITY||Slope|-1.78|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
91628049|NCT02420990|183147344|SUPERIORITY||Slope|-0.64|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
91628050|NCT02420990|183147344|SUPERIORITY||Slope|0.07|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
91628051|NCT02420990|183147344|SUPERIORITY||Slope|0.0|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
91628052|NCT02420990|183147344|SUPERIORITY||Slope|-1.44|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
91628053|NCT02420990|183147345|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
91628054|NCT01150760|183147350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0007|||||||Chi-squared|||||||0.0007
91628055|NCT01150760|183147351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|||<|0.0001|||||||Chi-squared|||||||< 0.0001
91628056|NCT01150760|183147352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.0001|||||||Chi-squared|||||||0.0001
91628057|NCT01150760|183147353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1022|||||||Chi-squared|||||||0.1022
91628058|NCT01150760|183147354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001|||||||Chi-squared|||||||< 0.0001
91628059|NCT01150760|183147355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91628060|NCT01150760|183147356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0012|||||||Chi-squared|||||||0.0012
91628061|NCT01150760|183147357|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.003|||||||Chi-squared|||||||0.0030
91628062|NCT01150760|183147358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.7637|||||||Chi-squared|||||||0.7637
91628063|NCT01150760|183147359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.0402|||||||Chi-squared|||||||0.0402
91628064|NCT01150760|183147360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0755|||||||Chi-squared|||||||0.0755
91482752|NCT01227564|182839152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.4145|TWO_SIDED|95.0|-0.105|0.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.250|-0.105|0.4145
91482753|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011||||0.5134|TWO_SIDED|95.0|-0.043|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.022|-0.043|0.5134
91525400|NCT02277743|182926186|SUPERIORITY||LS mean difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.16|-2.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.80|-5.16|< 0.0001
91525401|NCT02277743|182926186|SUPERIORITY||LS mean difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.87|-2.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.49|-4.87|< 0.0001
91525402|NCT02277743|182926187|SUPERIORITY||LS mean difference|-6.5|||<|0.0001|TWO_SIDED|95.0|-8.02|-5.01||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.01|-8.02|< 0.0001
91628065|NCT01150760|183147361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0532|||||||Chi-squared|||||||0.0532
91628066|NCT01150760|183147362|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||< 0.0001
91525403|NCT02277743|182926187|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.44|-4.32||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-4.32|-7.44|< 0.0001
91525404|NCT02277743|182926188|SUPERIORITY||LS mean difference|-2.2||||0.0006|TWO_SIDED|95.0|-3.44|-0.95||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-0.95|-3.44|0.0006
91525405|NCT02277743|182926188|SUPERIORITY||LS mean difference|-2.2||||0.0003|TWO_SIDED|95.0|-3.46|-1.03||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.03|-3.46|0.0003
91628067|NCT01150760|183147363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91664466|NCT03214588|183222787|SUPERIORITY||Least Squares Mean Difference|-0.00054|STANDARD_ERROR_OF_MEAN|0.000746|>|0.999|TWO_SIDED|90.0|-0.00179|0.0007||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00070|-0.00179|>0.999
91628068|NCT01975675|183147378|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
91628069|NCT01975675|183147378|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
91628070|NCT01975675|183147379|SUPERIORITY_OR_OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.2|1.0|||||The 95% confidence interval (CI) on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||1.0|-10.2|
91628071|NCT01975675|183147379|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-4.2|4.2|||||The 95% CI on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||4.2|-4.2|
91628072|NCT01015820|183147405|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.001
91628073|NCT01015820|183147406|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.03
91628074|NCT01998399|183147407|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||Total enrollment only 25 patients and the study was terminated early due to low enrollment. No further statistical analysis was done.||||0.41
91628075|NCT01711658|183147423|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.3436|TWO_SIDED|95.0|0.56|1.46|||Log Rank|One-sided significance level = 0.1803|Reference level = IMRT + cisplatin + placebo|Hazard ratio (lapatinib/placebo) set at 0.65 (35% reduction), 1-sided alpha 0.20 (final test at 0.1803 accounting for 1 interim analysis), logrank test, 80% power, 69 events in 128 randomized (142 total enrolled) patients required. Final analysis at 67 (of 69) events drops power to 79%.||1.46|0.56|0.3436
91628076|NCT01711658|183147424|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5836|TWO_SIDED|95.0|0.61|1.86|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.86|0.61|0.5836
91664467|NCT03214588|183222787|SUPERIORITY||Least Squares Mean Difference|-0.00069|STANDARD_ERROR_OF_MEAN|0.000616|>|0.999|TWO_SIDED|90.0|-0.00172|0.00033||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00033|-0.00172|>0.999
91664468|NCT03214588|183222788|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.782||0.135|TWO_SIDED|90.0|-2.18|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.44|-2.18|0.135
91664469|NCT03214588|183222788|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.64||0.818|TWO_SIDED|90.0|-0.48|1.66||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.66|-0.48|0.818
91664470|NCT03214588|183222788|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.77||0.591|TWO_SIDED|90.0|-1.11|1.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.47|-1.11|0.591
91664471|NCT03214588|183222788|SUPERIORITY||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.643||0.713|TWO_SIDED|90.0|-0.71|1.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.44|-0.71|0.713
91664472|NCT03214588|183222788|SUPERIORITY||Least Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.822||0.616|TWO_SIDED|90.0|-1.13|1.62||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.62|-1.13|0.616
91664473|NCT03214588|183222788|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.679||0.708|TWO_SIDED|90.0|-0.76|1.51||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.51|-0.76|0.708
91482754|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.6083|TWO_SIDED|95.0|-0.024|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.041|-0.024|0.6083
91525406|NCT02277743|182926189|SUPERIORITY||LS mean difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-35.04|-18.91||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.91|-35.04|< 0.0001
91628077|NCT01711658|183147425|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1743|TWO_SIDED|95.0|0.25|1.65|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.65|0.25|0.1743
91664474|NCT03214588|183222789|SUPERIORITY||Least Squares Mean Difference|-0.00039|STANDARD_ERROR_OF_MEAN|0.000604||0.741|TWO_SIDED|90.0|-0.0014|0.00062||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.00062|-0.00140|0.741
91664475|NCT03214588|183222789|SUPERIORITY||Least Squares Mean Difference|-0.00093|STANDARD_ERROR_OF_MEAN|0.000505||0.964|TWO_SIDED|90.0|-0.00177|-0.00008||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.00008|-0.00177|0.964
91691945|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4017||95.0|-0.14|0.35|||ANCOVA|||Pressing Spontaneous Pain Cycle 9||0.35|-0.14|0.4017
91628078|NCT01711658|183147426|SUPERIORITY|||||||0.7989|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.7989
91628079|NCT01711658|183147427|SUPERIORITY|||||||0.3728||||||IMRT|Fisher Exact|Two-sided significance level = 0.05||||||0.3728
91628080|NCT01711658|183147427|OTHER|||||||0.7781||||||Cisplatin|Fisher Exact|Two-sided significance level = 0.05||||||0.7781
91628081|NCT01711658|183147427|OTHER|||||||0.8||||||Pre-IMRT lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.8000
91628082|NCT01711658|183147427|OTHER|||||||0.6459||||||Concurrent lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.6459
91628083|NCT01711658|183147427|OTHER|||||||0.4792||||||Maintenance lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.4792
91628084|NCT01711658|183147428|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6735|TWO_SIDED|95.0|0.62|2.17|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||2.17|0.62|0.6735
91628085|NCT01459068|183147458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.59|-0.4||a priori threshold for statistical significance was 0.05.|longitudinal model|longitudinal to model within-person change in mean scores||||-0.40|-0.59|<0.001
91628086|NCT01459068|183147459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|power calculations were not done for secondary outcomes|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.59|-0.28|||longitudinal model|||||-0.28|-0.59|<0.001
91628087|NCT01459068|183147460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.51|-0.35||a priori threshold for significance set at 0.05|longitudinal model|longitudinal analysis modeling within-person change in mean scores||||-0.35|-0.51|<0.001
91628088|NCT01459068|183147461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations on secondary outcomes|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.61|-0.34|||longitudinal model|||||-0.34|-0.61|<0.001
91628089|NCT01459068|183147462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||longitudinal model|||||-0.15|-0.34|<0.001
91628090|NCT01459068|183147463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.896|TWO_SIDED|95.0|-0.44|0.5|||longitudinal model|||||0.50|-0.44|0.896
91628091|NCT02023112|183147466|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|91.5|||||TWO_SIDED|95.0|80.1|96.6|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||96.6|80.1|
91628092|NCT02023112|183147466|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|75.0|||||TWO_SIDED|95.0|61.2|85.1|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||85.1|61.2|
91628093|NCT00701441|183147498|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||For comparing pre versus post, paired t tests were used. We considered tests in the hypothesized direction conclusive|t-test, 2 sided|For each comparison, we tested at the 0.05 level with double-sided P values. We used no correction for multiple testing when declaring significance.||Flow mediated dilation = \[(average maximum dilation post cuff deflation - average baseline diameter)/ average baseline diameter\]100||||0.02
91628094|NCT00701441|183147499|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||We only consider tests in the hypothesized direction conclusive, so testing is conservative from that perspective. However, we used no correction for multiple testing when declaring significance|t-test, 2 sided|||For comparing pre- versus post-treatment, paired t tests were used. For each variable and comparison, we tested at the 0.05 level with double-sided P values.||||0.02
91628095|NCT01068717|183147514|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric least squares (LS) mean|109.53|||||TWO_SIDED|90.0|102.67|116.85||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||116.85|102.67|
91628096|NCT01068717|183147514|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.37|||||TWO_SIDED|90.0|85.7|117.56||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||117.56|85.70|
91664476|NCT03214588|183222789|SUPERIORITY||Least Squares Mean Difference|-0.00014|STANDARD_ERROR_OF_MEAN|0.000772||0.573|TWO_SIDED|90.0|-0.00143|0.00115||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00115|-0.00143|0.573
91664477|NCT03214588|183222789|SUPERIORITY||Least Squares Mean Difference|-0.00044|STANDARD_ERROR_OF_MEAN|0.000646||0.749|TWO_SIDED|90.0|-0.00152|0.00064||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00064|-0.00152|0.749
91664478|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.154||0.571|TWO_SIDED|90.0|-0.23|0.29||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.29|-0.23|0.571
91525407|NCT02277743|182926189|SUPERIORITY||LS mean difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-33.06|-18.12||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.12|-33.06|< 0.0001
91664479|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.126||0.963|TWO_SIDED|90.0|0.02|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.44|0.02|0.963
91664480|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.165||0.515|TWO_SIDED|90.0|-0.27|0.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.28|-0.27|0.515
91482755|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001||||0.9401|TWO_SIDED|95.0|-0.029|0.027||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.027|-0.029|0.9401
91482756|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018||||0.295|TWO_SIDED|95.0|-0.051|0.016||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.016|-0.051|0.2950
91482757|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.8817|TWO_SIDED|95.0|-0.031|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.037|-0.031|0.8817
91482758|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6072|TWO_SIDED|95.0|-0.037|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.022|-0.037|0.6072
91482759|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.6259|TWO_SIDED|95.0|-0.06|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.036|-0.060|0.6259
91482760|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.2807|TWO_SIDED|95.0|-0.023|0.076||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.076|-0.023|0.2807
91482761|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.008||||0.7224|TWO_SIDED|95.0|-0.035|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.050|-0.035|0.7224
91525408|NCT02277743|182926190|SUPERIORITY||LS mean difference|-16.5|||<|0.0001|TWO_SIDED|95.0|-21.08|-11.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-11.90|-21.08|< 0.0001
91628097|NCT01068717|183147515|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.02|||||TWO_SIDED|90.0|91.29|107.41||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states||107.41|91.29|
91664481|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.138||0.986|TWO_SIDED|90.0|0.08|0.54||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.54|0.08|0.986
91691946|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4113||95.0|-0.1|0.24|||ANCOVA|||Pressing Spontaneous Pain LOCF Endpoint||0.24|-0.10|0.4113
91628098|NCT01068717|183147515|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.21|||||TWO_SIDED|90.0|96.86|103.67||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.67|96.86|
91628099|NCT01068717|183147517|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
91628100|NCT01068717|183147517|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.78|||||TWO_SIDED|90.0|96.61|103.05||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.05|96.61|
91628101|NCT01068717|183147522|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
91628102|NCT01068717|183147522|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|101.82|||||TWO_SIDED|90.0|96.1|107.88||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.88|96.10|
91664482|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.162||0.718|TWO_SIDED|90.0|-0.18|0.37||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.37|-0.18|0.718
91691947|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3011||95.0|-0.06|0.02|||ANCOVA|||Paroxysmal Pain Cycle 3||0.02|-0.06|0.3011
91691948|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.4482||95.0|-0.26|0.12|||ANCOVA|||Paroxysmal Pain Cycle 4||0.12|-0.26|0.4482
91691949|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.3058||95.0|-0.31|0.1|||ANCOVA|||Paroxysmal Pain Cycle 5||0.10|-0.31|0.3058
91691950|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.3035||95.0|-0.38|0.12|||ANCOVA|||Paroxysmal Pain Cycle 6||0.12|-0.38|0.3035
91691951|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.9636||95.0|-0.46|0.48|||ANCOVA|||Paroxysmal Pain Cycle 7||0.48|-0.46|0.9636
91691952|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.366||95.0|-0.38|1.02|||ANCOVA|||Paroxysmal Pain Cycle 8||1.02|-0.38|0.3660
91691953|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4093||95.0|-0.69|0.29|||ANCOVA|||Paroxysmal Pain Cycle 9||0.29|-0.69|0.4093
91792082|NCT03036800|183461938|SUPERIORITY||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.32|12.86|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.86|3.32|<0.001
91628103|NCT01068717|183147523|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|102.64|||||TWO_SIDED|90.0|98.31|107.16||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.16|98.31|
91628104|NCT01068717|183147523|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|99.22||||||90.0|96.48|102.04||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||102.04|96.48|
91792083|NCT03036800|183461939|SUPERIORITY||Odds Ratio (OR)|8.08|||<|0.001|TWO_SIDED|95.0|3.8|17.16|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||17.16|3.80|<0.001
91525409|NCT02277743|182926190|SUPERIORITY||LS mean difference|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.62|-10.5||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-10.50|-19.62|< 0.0001
91628105|NCT01068717|183147524|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.04|||||TWO_SIDED|95.0|92.9|105.59||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||105.59|92.90|
91628106|NCT01068717|183147524|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.77|||||TWO_SIDED|95.0|96.82|109.09||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||109.09|96.82|
91628107|NCT01449955|183147542|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||ANOVA comparing the results of change over time (e.g., comparing baseline to 1 month posttreatment) as well as comparing differences between condition (e.g., placebo compared to rapamycin).||||>0.05
91628108|NCT01449955|183147543|SUPERIORITY||||||>|0.5|||||||ANOVA|||||||> 0.5
91628109|NCT01449955|183147544|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
91628110|NCT01449955|183147545|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
91628111|NCT01449955|183147546|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< .05
91628112|NCT01449955|183147547|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
91628113|NCT01176240|183147564|SUPERIORITY_OR_OTHER|||||||0.978|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||Study 306A was initially designed as a blinded interim analysis by an independent DMC to ensure that the overall study was adequately powered. Study 306A was not powered to provide statistical significance as a stand alone study. Thus, no additional efficacy end points were prospectively defined beyond the primary end point.||||0.978
91792084|NCT03036800|183461940|SUPERIORITY||Odds Ratio (OR)|2.28||||0.065|TWO_SIDED|95.0|0.95|5.47|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||5.47|0.95|0.065
91525410|NCT01557322|182926197|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Morning Stiffness \> 1 Hour: p-value was calculated using chi-square test.||||0.010
91482762|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.8532|TWO_SIDED|95.0|-0.08|0.067||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.067|-0.080|0.8532
91482763|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.3116|TWO_SIDED|95.0|-0.038|0.116||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.116|-0.038|0.3116
91482764|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.6246|TWO_SIDED|95.0|-0.049|0.082||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.082|-0.049|0.6246
91482765|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8697|TWO_SIDED|95.0|-0.092|0.108||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.108|-0.092|0.8697
91482766|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072||||0.1707|TWO_SIDED|95.0|-0.032|0.176||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.176|-0.032|0.1707
91482767|NCT01227564|182839153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.3732|TWO_SIDED|95.0|-0.049|0.129||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.129|-0.049|0.3732
91628114|NCT01176240|183147565|SUPERIORITY_OR_OTHER|||||||0.018||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.018
91525411|NCT01557322|182926197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Arthritis or Deformity of 3 or More Joint Areas: p-value was calculated using chi-square test.||||<0.001
91525412|NCT01557322|182926197|SUPERIORITY_OR_OTHER|||||||0.363|TWO_SIDED||||||Chi-squared|||Arthritis/Deformity of Hand/Joint: p-value was calculated using chi-square test.||||0.363
91525413|NCT01557322|182926197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Symmetry: p-value was calculated using chi-square test.||||<0.001
91525414|NCT01557322|182926197|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Nodules: p-value was calculated using chi-square test.||||<0.001
91628115|NCT01176240|183147567|SUPERIORITY_OR_OTHER|||||||0.6||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the first secondary endpoint was not positive, statistical analysis was not performed on additional secondary endpoints.|Wilcoxon (Mann-Whitney)|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.60
91628116|NCT01176240|183147573|SUPERIORITY_OR_OTHER|||||||0.238|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.238
91628117|NCT00771173|183147576|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.||||.745
91628118|NCT00807014|183147577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.|ANCOVA|||||||<0.001
91628119|NCT00948428|183147605|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval -0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent|Mean Difference (Net)|-0.85|||||TWO_SIDED|90.0|-10.84|9.15||||||||9.15|-10.84|
91628120|NCT00948428|183147605|SUPERIORITY|||||||0.0001|||||||ANOVA|||Based on Intent-to-Treat Population||||0.0001
91482768|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.7259|TWO_SIDED|95.0|-0.04|0.028||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.028|-0.040|0.7259
91482769|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.3517|TWO_SIDED|95.0|-0.018|0.051||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.051|-0.018|0.3517
91482770|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.7311|TWO_SIDED|95.0|-0.024|0.035||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.035|-0.024|0.7311
91482771|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6446|TWO_SIDED|95.0|-0.041|0.026||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.026|-0.041|0.6446
91482772|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.064|TWO_SIDED|95.0|-0.002|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.066|-0.002|0.0640
91482773|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012||||0.4057|TWO_SIDED|95.0|-0.017|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.041|-0.017|0.4057
91525415|NCT01557322|182926197|SUPERIORITY_OR_OTHER|||||||0.605|TWO_SIDED||||||Chi-squared|||Rheumatoid Factor Positive: p-value was calculated using chi-square test.||||0.605
91525416|NCT01557322|182926197|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Chi-squared|||Erosions on Hand or Feet X-Ray: p-value was calculated using chi-square test.||||0.038
91525417|NCT01557322|182926198|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Sicca Syndrome: p-value was calculated using chi-square test.||||<0.001
91525418|NCT01557322|182926198|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||Serosal Involvement: p-value was calculated using chi-square test.||||0.024
91628121|NCT00948428|183147606|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Partial Clearance rates in the PP population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-12.11|5.95||||||||5.95|-12.11|
91628122|NCT00948428|183147607|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the ITT population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-0.5|||||TWO_SIDED|90.0|-9.92|8.88||||||||8.88|-9.92|
91664483|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.133||0.986|TWO_SIDED|90.0|0.08|0.52||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.52|0.08|0.986
91691954|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5208||95.0|-0.39|0.2|||ANCOVA|||Paroxysmal Pain LOCF Endpoint||0.20|-0.39|0.5208
91525419|NCT01557322|182926198|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Chi-squared|||Eye Involvement: p-value was calculated using chi-square test.||||0.257
91525420|NCT01557322|182926198|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||Systemic Vasculitis: p-value was calculated using chi-square test.||||0.026
91628123|NCT02037204|183147613|NON_INFERIORITY|A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|||||<|0.05|||||||ANOVA|||A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.||||<0.05
91482774|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.5742|TWO_SIDED|95.0|-0.066|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.037|-0.066|0.5742
91664484|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.153|TWO_SIDED|90.0|-0.4|0.09||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.09|-0.40|0.153
91664485|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.119||0.861|TWO_SIDED|90.0|-0.07|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.33|-0.07|0.861
91664486|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.443|TWO_SIDED|90.0|-0.22|0.18||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.18|-0.22|0.443
91664487|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.359|TWO_SIDED|90.0|-0.2|0.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.13|-0.20|0.359
91664488|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.157||0.268|TWO_SIDED|90.0|-0.36|0.17||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.17|-0.36|0.268
91664489|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.411|TWO_SIDED|90.0|-0.24|0.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.19|-0.24|0.411
91525421|NCT01557322|182926198|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED||||||Chi-squared|||Nailfold Vasculitis: p-value was calculated using chi-square test.||||0.725
91525422|NCT01557322|182926198|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared|||Pulmonary Fibrosis: p-value was calculated using chi-square test.||||0.220
91664490|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.358|TWO_SIDED|90.0|-0.31|0.2||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.20|-0.31|0.358
91664491|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.123||0.946|TWO_SIDED|90.0|0.0|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.41|0.00|0.946
91691955|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9931||95.0|-0.17|0.17|||ANCOVA|||Evoke Pain Cycle 2||0.17|-0.17|0.9931
91525423|NCT01557322|182926198|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||Other: p-value was calculated using chi-square test.||||0.620
91691956|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.5867||95.0|-0.25|0.44|||ANCOVA|||Evoke Pain Cycle 3||0.44|-0.25|0.5867
91691957|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2748||95.0|-0.37|0.11|||ANCOVA|||Evoke Pain Cycle 4||0.11|-0.37|0.2748
91525424|NCT01557322|182926199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Knee Replacement: p-value was calculated using chi-square test.||||<0.001
91525425|NCT01557322|182926199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Hip Replacement: p-value was calculated using chi-square test.||||<0.001
91525426|NCT01557322|182926199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Shoulder Replacement: p-value was calculated using chi-square test.||||<0.001
91525427|NCT01557322|182926199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Elbow Replacement: p-value was calculated using chi-square test.||||<0.001
91525428|NCT01557322|182926199|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test.||||0.001
91525429|NCT01557322|182926199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Neck Surgery: p-value was calculated using chi-square test.||||<0.001
91691958|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.5521||95.0|-0.51|0.28|||ANCOVA|||Evoke Pain Cycle 5||0.28|-0.51|0.5521
91525430|NCT01557322|182926200|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||P-value was calculated using chi-square test.||||<0.001
91628124|NCT05516134|183147634|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||baseline vs. treatment, paired sample t-test||||<0.01
91628125|NCT05516134|183147635|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
91628126|NCT05516134|183147636|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
91628127|NCT05516134|183147637|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
91628128|NCT05516134|183147638|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
91628129|NCT05516134|183147639|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||.11
91628130|NCT05516134|183147640|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
91628131|NCT05516134|183147641|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91628132|NCT00420342|183147675|SUPERIORITY_OR_OTHER|||||||0.1182||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1182
91628133|NCT00420342|183147675|SUPERIORITY_OR_OTHER|||||||0.2224||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.2224
91628134|NCT00420342|183147675|SUPERIORITY_OR_OTHER|||||||0.6929||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.6929
91628135|NCT00420342|183147676|SUPERIORITY_OR_OTHER|||||||0.0702||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.0702
91628136|NCT00420342|183147676|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1980
91628137|NCT00420342|183147676|SUPERIORITY_OR_OTHER|||||||0.5777||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.5777
91628138|NCT03053401|183147687|OTHER|Test of difference was conducted.||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
91628139|NCT03053401|183147688|OTHER|||||||0.762||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.762
91628140|NCT03053401|183147688|OTHER|||||||0.41||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon Rank Sum Test with Exact Option|||||||0.410
91628141|NCT03053401|183147689|OTHER|Test of Difference conducted.||||||0.454|||||||t-test, 2 sided|||||||0.454
91628142|NCT00407550|183147739|SUPERIORITY|||||||0.015|||||||Log Rank|||||||0.015
91628143|NCT00407550|183147740|SUPERIORITY|||||||0.56|||||||Log Rank|||||||0.56
91628144|NCT01444898|183147742|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||.07
91628145|NCT01444898|183147743|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91628146|NCT01444898|183147744|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
91628147|NCT01444898|183147745|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
91628148|NCT01444898|183147746|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
91628149|NCT01444898|183147747|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
91628150|NCT01444898|183147748|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
91628151|NCT01444898|183147749|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
91628152|NCT01444898|183147750|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||.004
91628153|NCT01599806|183147752|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
91628154|NCT01599806|183147753|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
91525431|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Chi-squared|||High Blood Pressure: p-value was calculated using chi-square test.||||0.381
91525432|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Chi-squared|||Angina: p-value was calculated using chi-square test.||||0.006
91628155|NCT01599806|183147754|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
91628156|NCT01599806|183147755|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
91482775|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1336|TWO_SIDED|95.0|-0.013|0.093||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.093|-0.013|0.1336
91482776|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.013||||0.5734|TWO_SIDED|95.0|-0.033|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.058|-0.033|0.5734
91714125|NCT01386606|183319991|SUPERIORITY_OR_OTHER||Regression Coefficient|-110.9||||0.068|TWO_SIDED|95.0|-210.6|-11.23||P-value for Androxal 12.5 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-11.23|-210.6|0.068
91714126|NCT01386606|183319991|SUPERIORITY_OR_OTHER||Regression Coefficient|-148.5||||0.011|TWO_SIDED|95.0|-242.9|-54.05||P-value for Androxal 6.25 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-54.05|-242.9|0.011
91714127|NCT01386606|183319991|SUPERIORITY_OR_OTHER||Regression Coefficient|0.58|||<|0.001|TWO_SIDED|95.0|0.37|0.79||P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||0.79|0.37|<0.001
91714128|NCT01386606|183319992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.||||<0.001
91714129|NCT01386606|183319992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.||||<0.001
91714130|NCT01386606|183319992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.||||<0.001
91482777|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.016||||0.7067|TWO_SIDED|95.0|-0.104|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.071|-0.104|0.7067
91482778|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.36|TWO_SIDED|95.0|-0.049|0.132||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.132|-0.049|0.3600
91714131|NCT01386606|183319993|SUPERIORITY_OR_OTHER||Pearson Correlation|0.90993|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.||||<0.0001
91714132|NCT01386606|183319993|SUPERIORITY_OR_OTHER||Pearson Correlation|0.86541|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.||||<0.0001
91714133|NCT01386606|183319993|SUPERIORITY_OR_OTHER||Pearson Correlation|0.89643|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.||||<0.0001
91525433|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED||||||Chi-squared|||Heart Attack: p-value was calculated using chi-square test.||||0.215
91525434|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||Chi-squared|||Stroke: p-value was calculated using chi-square test.||||0.117
91525435|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Epilepsy: p-value was calculated using chi-square test.||||1.000
91628157|NCT01599806|183147756|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
91628158|NCT01599806|183147757|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
91628159|NCT01599806|183147758|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
91714134|NCT01386606|183319995|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.||||<0.001
91525436|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||Chi-squared|||Asthma: p-value was calculated using chi-square test.||||0.542
91792085|NCT03036800|183461941|SUPERIORITY||Odds Ratio (OR)|2.84||||0.206|TWO_SIDED|95.0|0.56|14.34|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.34|0.56|0.206
91628160|NCT01599806|183147759|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
91525437|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Chi-squared|||Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test.||||0.027
91628161|NCT01599806|183147760|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
91628162|NCT01599806|183147761|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
91628163|NCT01599806|183147762|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
91628164|NCT01599806|183147763|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
91628165|NCT01599806|183147764|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
91628166|NCT01599806|183147765|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
91628167|NCT01599806|183147766|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
91628168|NCT01599806|183147767|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
91628169|NCT01599806|183147768|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
91628170|NCT01599806|183147769|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
91628171|NCT01599806|183147770|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
91628172|NCT01599806|183147771|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
91525438|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Chi-squared|||Peptic Ulcer: p-value was calculated using chi-square test.||||0.566
91628173|NCT01599806|183147772|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
91628174|NCT01599806|183147773|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
91628175|NCT01599806|183147774|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
91628176|NCT01599806|183147775|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
91628177|NCT01599806|183147776|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
91628178|NCT01599806|183147777|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
91792086|NCT03036800|183461942|SUPERIORITY||Odds Ratio (OR)|3.23||||0.023|TWO_SIDED|95.0|1.17|8.9|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥32% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||8.90|1.17|0.023
91525439|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||Liver Disease: p-value was calculated using chi-square test.||||0.003
91525440|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.526|TWO_SIDED||||||Chi-squared|||Renal Disease: p-value was calculated using chi-square test.||||0.526
91525441|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED||||||Chi-squared|||Tuberculosis: p-value was calculated using chi-square test.||||0.802
91525442|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Demyelination: p-value was calculated using chi-square test.||||1.000
91628179|NCT01599806|183147778|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
91628180|NCT01599806|183147779|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
91628181|NCT01599806|183147780|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
91628182|NCT01599806|183147781|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
91628183|NCT01599806|183147782|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
91525443|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||Chi-squared|||Diabetes: p-value was calculated using chi-square test.||||0.385
91628184|NCT01599806|183147783|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
91628185|NCT01599806|183147784|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
91628186|NCT00563368|183147820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|0.831||0.0009|TWO_SIDED|95.0|1.13|4.39||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.39|1.13|0.0009
91628187|NCT00563368|183147820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.825||0.0001|TWO_SIDED|95.0|1.53|4.77||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.77|1.53|0.0001
91628188|NCT00563368|183147820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|5.86|9.12||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.12|5.86|<0.0001
91628189|NCT00563368|183147820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|STANDARD_ERROR_OF_MEAN|0.832|<|0.0001|TWO_SIDED|95.0|1.69|4.96||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.96|1.69|<0.0001
91628190|NCT00563368|183147820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|0.828||0.0003|TWO_SIDED|95.0|1.38|4.63||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.63|1.38|0.0003
91628191|NCT00563368|183147820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.75|STANDARD_ERROR_OF_MEAN|0.831|<|0.0001|TWO_SIDED|95.0|5.11|8.38||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||8.38|5.11|<0.0001
91628192|NCT00563368|183147821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.028|STANDARD_ERROR_OF_MEAN|0.5832||0.014|TWO_SIDED|95.0|1.154|3.563||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.563|1.154|0.0140
91628193|NCT00563368|183147821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.246|STANDARD_ERROR_OF_MEAN|0.6418||0.0046|TWO_SIDED|95.0|1.283|3.932||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.932|1.283|0.0046
91628194|NCT00563368|183147821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.623|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001|TWO_SIDED|95.0|5.424|20.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||20.81|5.424|<0.0001
91628195|NCT00563368|183147821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.568|STANDARD_ERROR_OF_MEAN|0.7391||0.0011|TWO_SIDED|95.0|1.46|4.514||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.514|1.460|0.0011
91628196|NCT00563368|183147821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|STANDARD_ERROR_OF_MEAN|0.6158||0.0066|TWO_SIDED|95.0|1.241|3.781||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.781|1.241|0.0066
91525444|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Chi-squared|||Hyperthyroidism: p-value was calculated using chi-square test.||||0.048
91628197|NCT00563368|183147821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.063|STANDARD_ERROR_OF_MEAN|3.0857|<|0.0001|TWO_SIDED|95.0|4.65|17.66||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||17.66|4.650|<0.0001
91628198|NCT03326583|183147828|SUPERIORITY|||||||0.05|||||||Fisher Exact|||||||.05
91628199|NCT03326583|183147829|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
91664492|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.193||0.505|TWO_SIDED|90.0|-0.32|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.32|0.505
91664493|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.158||0.658|TWO_SIDED|90.0|-0.2|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.20|0.658
91664494|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.184||0.649|TWO_SIDED|90.0|-0.24|0.38||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.38|-0.24|0.649
91664495|NCT03214588|183222790|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.661|TWO_SIDED|90.0|-0.19|0.32||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.32|-0.19|0.661
91525445|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Chi-squared|||Depression: p-value was calculated using chi-square test.||||0.308
91628200|NCT03326583|183147830|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
91664496|NCT03214588|183222791|SUPERIORITY||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|1.078||0.992|TWO_SIDED|90.0|0.86|4.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.47|0.86|0.992
91664497|NCT03214588|183222791|SUPERIORITY||Least Squares Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|0.892||0.999|TWO_SIDED|90.0|1.29|4.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.28|1.29|0.999
91664498|NCT03214588|183222791|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.338||0.616|TWO_SIDED|90.0|-1.84|2.64||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.64|-1.84|0.616
91664499|NCT03214588|183222791|SUPERIORITY||Least Squares Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.131||0.823|TWO_SIDED|90.0|-0.83|2.95||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.95|-0.83|0.823
91691959|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.39||0.6734||95.0|-0.96|0.62|||ANCOVA|||Evoke Pain Cycle 6||0.62|-0.96|0.6734
91691960|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.1214||95.0|-0.16|1.33|||ANCOVA|||Evoke Pain Cycle 7||1.33|-0.16|0.1214
91691961|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.51||0.1845||95.0|-0.34|1.72|||ANCOVA|||Evoke Pain Cycle 8||1.72|-0.34|0.1845
91691962|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.37||0.6863||95.0|-0.6|0.9|||ANCOVA|||Evoke Pain Cycle 9||0.90|-0.60|0.6863
91691963|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9273||95.0|-0.51|0.56|||ANCOVA|||Evoke Pain LOCF Endpoint||0.56|-0.51|0.9273
91525446|NCT01557322|182926201|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||Cancer: p-value was calculated using chi-square test.||||0.033
91525447|NCT01557322|182926202|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||0.188
91525448|NCT01557322|182926203|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Systolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.016
91525449|NCT01557322|182926203|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||t-test, 2 sided|||Diastolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.369
91628201|NCT03326583|183147831|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
91628202|NCT01784614|183147842|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.96||||0.908|TWO_SIDED|90.0|0.56|1.65|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.|||1.65|0.56|0.908
91628203|NCT01784614|183147842|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.67||||0.083|TWO_SIDED|90.0|0.45|0.98|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.|||0.98|0.45|0.083
91628204|NCT01784614|183147842|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.53||||0.01|TWO_SIDED|90.0|0.36|0.78|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.|||0.78|0.36|0.010
91628205|NCT01784614|183147842|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.51|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.|||0.51|0.18|<0.001
91482779|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.7454|TWO_SIDED|95.0|-0.065|0.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.090|-0.065|0.7454
91482780|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.9037|TWO_SIDED|95.0|-0.113|0.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.100|-0.113|0.9037
91628206|NCT03168555|183147849|EQUIVALENCE|compares visit 1 with visit 2||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91628207|NCT03168555|183147851|EQUIVALENCE|compares visit 1 with visit 2||||||0.63|||||||paired t-test|lognormalized values||compares visit 1 with visit 2||||0.63
91628208|NCT03168555|183147852|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91628209|NCT03168555|183147853|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91628210|NCT03168555|183147854|OTHER|Spearman correlation||||||0.41|||||||Spearman correlation|||||||0.41
91628211|NCT03168555|183147855|OTHER|Spearman correlation||||||0.35|||||||Spearman correlation|||||||0.35
91628212|NCT03168555|183147855|OTHER|||||||0.03|||||||Spearman correlation|||||||0.03
91525450|NCT01557322|182926204|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
91628213|NCT03168555|183147856|EQUIVALENCE|comparing visit 1 with visit 2||||||0.36|||||||paired t-test|||||||0.36
91628214|NCT03168555|183147857|SUPERIORITY|||||||0.29|||||||paired t-test|||||||0.29
91628215|NCT03168555|183147858|OTHER|Spearman correlation||||||0.73|||||||Spearman correlation|||||||0.73
91628216|NCT03168555|183147858|OTHER|||||||0.77|||||||Spearman correlation|||||||0.77
91628217|NCT03168555|183147859|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
91628218|NCT01235507|183147877|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628219|NCT01235507|183147877|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628220|NCT01235507|183147877|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628221|NCT01235507|183147879|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628222|NCT01235507|183147879|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628223|NCT01235507|183147879|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628224|NCT01235507|183147880|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628225|NCT01235507|183147880|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628226|NCT01235507|183147880|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628227|NCT01235507|183147881|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628228|NCT01235507|183147881|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628229|NCT01235507|183147881|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628230|NCT01235507|183147882|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628231|NCT01235507|183147882|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628232|NCT01235507|183147882|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628233|NCT01235507|183147883|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628234|NCT01235507|183147883|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628235|NCT01235507|183147883|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628236|NCT01235507|183147884|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
91628237|NCT01235507|183147884|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
91628238|NCT01235507|183147884|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
91628239|NCT02738580|183147893|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|0.26|<|0.05|TWO_SIDED|||||The proportion of patients with elevated Progesterone on last day of stimulation(\>1.5 ng/mL) was compared between both groups using the Chi-square test.|t-test, 2 sided|||||||<0.05
91628240|NCT02738580|183147894|SUPERIORITY||||||<|0.49|||||||t-test, 1 sided|||||||<0.49
91664500|NCT03214588|183222791|SUPERIORITY||Least Squares Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|1.266||0.942|TWO_SIDED|90.0|-0.1|4.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.13|-0.10|0.942
91664501|NCT03214588|183222791|SUPERIORITY||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|1.053||0.975|TWO_SIDED|90.0|0.35|3.87||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||3.87|0.35|0.975
91714135|NCT01386606|183319995|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.||||<0.001
91714136|NCT01386606|183319995|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.||||<0.001
91714137|NCT00593814|183320006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91714138|NCT03429348|183320036|SUPERIORITY||Mean Difference (Final Values)|1.18||||9e-07|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values.||||||0.0000009
91714139|NCT03429348|183320036|SUPERIORITY||Mean Difference (Final Values)|1.35||||1.8e-05|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values||||||0.000018
91714140|NCT01307787|183320068|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.002
91714141|NCT01307787|183320069|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.47
91714142|NCT01307787|183320070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.24
91714143|NCT01307787|183320071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.16
91482781|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2082|TWO_SIDED|95.0|-0.04|0.181||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.181|-0.040|0.2082
91714144|NCT01307787|183320072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.21
91714145|NCT01307787|183320073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.07
91525451|NCT01557322|182926204|SUPERIORITY_OR_OTHER|||||||0.3746|TWO_SIDED||||||Regression, Linear|||Change at Month 60: p-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.3746
91525452|NCT01557322|182926205|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
91628241|NCT00583661|183147895|NON_INFERIORITY_OR_EQUIVALENCE|Sample size determination: A sample of 24 subjects followed for approximately 100 days provides greater than 80% power to conclude that, with a 1-sided alpha=0.025 test, the SAE rate of the EXCOR (assumed to be 0.21 per patient-day) is less than 0.25 per patient-day. This sample size was estimated using 10,000 simulations of this study. A total enrollment of 48 subjects (24 per cohort) were enrolled and implanted with the EXCOR® Pediatric.|Poisson confidence interval|0.25|||<|0.05|TWO_SIDED|95.0|0.0|0.25||A Poisson exact confidence interval was calculated and the critical-value method was used for the significance testing. Success was defined as the upper bound of the 95% Poisson exact confidence interval being less than 0.25.|Poisson confidence interval|||Ho: EXCOR® SAE Rate \>=0.25 Ha: EXCOR® SAE Rate \< 0.25 Where serious adverse event (SAE) rate is calculated as the total number of serious adverse events divided by the sum of days all patients are on the EXCOR® Pediatric device, and 0.25 serious adverse events per patient-day is the success criterion. Study success in terms of safety will be demonstrated by the upper bound of a two-sided 95% Poisson exact confidence interval being less than 0.25.||0.25|0|<0.05
91628242|NCT01324687|183147897|SUPERIORITY_OR_OTHER||Rate ratio|0.8387||||0.017|TWO_SIDED|95.0|0.7261|0.9689|||GEE / Poisson regression models|||Rate ratio of ED use rate of the intervention group as compared to the control group.||0.9689|0.7261|0.017
91628243|NCT02690168|183147919|OTHER|||||||0.0053|||||||t-test, 2 sided|||||||0.0053
91628244|NCT02690168|183147920|OTHER|||||||0.477|||||||t-test, 2 sided|||||||0.477
91628245|NCT02690168|183147921|OTHER|||||||0.917|||||||t-test, 2 sided|||||||0.917
91628246|NCT02690168|183147923|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
91628247|NCT02758119|183147931|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91628248|NCT04209400|183147934|NON_INFERIORITY|P \< 0.05 is considered a statistically significant difference in seroconversion between the two groups.||||||1|||||||Chi-squared|||The null hypothesis is that the vaccines equally affect the achievement of seroconversion level.||||1
91628249|NCT01496274|183147942|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.|Wilcoxon signed-rank test|||A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.||||<0.0001
91628250|NCT00892957|183147992|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Likelihood ratio chi-square test|||||||<0.0001
91628251|NCT00892957|183147993|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.001
91525453|NCT01557322|182926206|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
91525454|NCT01557322|182926207|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.154
91525455|NCT01557322|182926208|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.108
91525456|NCT01557322|182926209|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.199
91525457|NCT01557322|182926210|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
91628252|NCT00892957|183147994|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.012
91628253|NCT00892957|183147995|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.158
91628254|NCT00892957|183147997|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.380
91628255|NCT00892957|183147998|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.545
91628256|NCT03296787|183148063|SUPERIORITY|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.7265|||||||ANOVA|||||||0.7265
91628257|NCT03296787|183148063|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.9839|||||||ANOVA|||||||0.9839
91628258|NCT03296787|183148063|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.9393|||||||ANOVA|||||||0.9393
91628259|NCT03296787|183148063|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.1321|||||||ANOVA|||||||0.1321
91628260|NCT03296787|183148064|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.36|||||||ANOVA|||||||0.3600
91628261|NCT03296787|183148064|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0816|||||||ANOVA|||||||0.0816
91628262|NCT03296787|183148064|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.2686|||||||ANOVA|||||||0.2686
91628263|NCT03296787|183148064|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0059|||||||ANOVA|||||||0.0059
91628264|NCT03296787|183148065|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0998|||||||ANOVA|||||||0.0998
91628265|NCT03296787|183148065|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0155|||||||ANOVA|||||||0.0155
91628266|NCT03296787|183148065|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0916|||||||ANOVA|||||||0.0916
91628267|NCT03296787|183148065|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0014|||||||ANOVA|||||||0.0014
91628268|NCT03296787|183148066|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0038|||||||ANOVA|||||||0.0038
91628269|NCT03296787|183148066|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0004|||||||ANOVA|||||||0.0004
91628270|NCT03296787|183148066|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0389|||||||ANOVA|||||||0.0389
91628271|NCT03296787|183148066|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0011|||||||ANOVA|||||||0.0011
91628272|NCT02823080|183148117|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91628273|NCT02823080|183148118|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91628274|NCT02823080|183148119|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91628275|NCT02823080|183148123|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91628276|NCT00676208|183148124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
91628277|NCT00676208|183148125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
91628278|NCT00669032|183148126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|ONE_SIDED||||||Chi-squared|||||||0.004
91628279|NCT00669032|183148127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525|TWO_SIDED||||||Chi-squared|||||||0.525
91628280|NCT00669032|183148128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.030
91628281|NCT00669032|183148129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
91628282|NCT00669032|183148130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
91628283|NCT00669032|183148131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
91628284|NCT00669032|183148132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
91628285|NCT00669032|183148133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
91628286|NCT00669032|183148134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||Chi-squared|||||||0.023
91628287|NCT00669032|183148135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
91628288|NCT00669032|183148136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9129|TWO_SIDED||||||Chi-squared|||||||0.9129
91664502|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.15|0.29||||||Change at Week 2, Bulbar||0.29|-0.15|
91664503|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.12|0.25||||||Change at Week 2, Bulbar||0.25|-0.12|
91664504|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.3|0.11||||||Change at Week 7, Bulbar||0.11|-0.30|
91664505|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.02|0.33||||||Change at Week 7, Bulbar||0.33|-0.02|
91664506|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.19|0.28||||||Change at Week 12, Bulbar||0.28|-0.19|
91664507|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|0.0|0.4||||||Change at Week 12, Bulbar||0.40|0.00|
91664508|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.689|||TWO_SIDED|90.0|0.83|3.14||||||Change at Week 2, Upper Limb Coordination||3.14|0.83|
91664509|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|90.0|0.06|1.97||||||Change at Week 2, Upper Limb Coordination||1.97|0.06|
91664510|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.882|||TWO_SIDED|90.0|-0.4|2.55||||||Change at Week 7, Upper Limb Coordination||2.55|-0.40|
91482782|NCT01227564|182839154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.5044|TWO_SIDED|95.0|-0.063|0.127||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.127|-0.063|0.5044
91664511|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.743|||TWO_SIDED|90.0|-1.06|1.43||||||Change at Week 7, Upper Limb Coordination||1.43|-1.06|
91664512|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|-0.48|2.91||||||Change at Week 12, Upper Limb Coordination||2.91|-0.48|
91664513|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-0.87|1.94||||||Change at Week 12, Upper Limb Coordination||1.94|-0.87|
91664514|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|90.0|-0.41|1.2||||||Change at Week 2, Lower Limb Coordination||1.20|-0.41|
91664515|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|90.0|0.12|1.45||||||Change at Week 2, Lower Limb Coordination||1.45|0.12|
91664516|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.837|||TWO_SIDED|90.0|-1.44|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.44|
91664517|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.707|||TWO_SIDED|90.0|-1.01|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.01|
91525458|NCT01557322|182926211|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
91525459|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
91664518|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.755|||TWO_SIDED|90.0|-0.27|2.25||||||Change at Week 12, Lower Limb Coordination||2.25|-0.27|
91664519|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.95|STANDARD_ERROR_OF_MEAN|0.626|||TWO_SIDED|90.0|-0.09|2.0||||||Change at Week 12, Lower Limb Coordination||2.00|-0.09|
91664520|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-0.8|1.3||||||Change at Week 2, Upright Stability||1.3|-0.8|
91664521|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|0.1|1.9||||||Change at Week 2, Upright Stability||1.9|0.1|
91525460|NCT01557322|182926213|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||Current DMARDs, Azathioprine: p-value was calculated using chi-square test.||||0.313
91525461|NCT01557322|182926213|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||1.000
91664522|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.3|0.2||||||Change at Week 7, Upright Stability||0.2|-1.3|
91664523|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|0.0|1.2||||||Change at Week 7, Upright Stability||1.2|0.0|
91664524|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|90.0|-1.2|0.7||||||Change at Week 12, Upright Stability||0.7|-1.2|
91664525|NCT03214588|183222792|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.3|1.3||||||Change at Week 12, Upright Stability||1.3|-0.3|
91664526|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|90.0|-0.13|0.15||||||Change at Week 2, Cough||0.15|-0.13|
91664527|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|90.0|-0.11|0.12||||||Change at Week 2, Cough||0.12|-0.11|
91664528|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Cough||0.11|-0.24|
91664529|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|90.0|-0.05|0.25||||||Change at Week 7, Cough||0.25|-0.05|
91664530|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|-0.11|0.25||||||Change at Week 12, Cough||0.25|-0.11|
91664531|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|90.0|-0.03|0.26||||||Change at Week 12, Cough||0.26|-0.03|
91664532|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.09|0.25||||||Change at Week 2, Speech||0.25|-0.09|
91664533|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.04|0.24||||||Change at Week 2, Speech||0.24|-0.04|
91664534|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|90.0|-0.16|0.08||||||Change at Week 7, Speech||0.08|-0.16|
91714146|NCT01307787|183320074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.4
91714147|NCT01307787|183320075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.6
91482783|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7687|TWO_SIDED|95.0|-0.23|0.17||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.17|-0.23|0.7687
91482784|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.6804|TWO_SIDED|95.0|-0.16|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.24|-0.16|0.6804
91482785|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9452|TWO_SIDED|95.0|-0.17|0.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.18|-0.17|0.9452
91525462|NCT01557322|182926213|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||0.066
91525463|NCT01557322|182926213|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Chi-squared|||Current DMARDs, Leflunomide: p-value was calculated using chi-square test.||||0.099
91628289|NCT01379924|183148138|SUPERIORITY||Odds Ratio (OR)|0.25||||0.037|TWO_SIDED|95.0|0.07|0.92|||Regression, Logistic|Adjusted for group differences at baseline and variables associated with differential study retention.|Usual care arm is reference group|Multiple logistic regression modeling used to compute adjusted odds ratios for 12-month follow-up data.||.92|.07|.037
91628290|NCT01379924|183148139|SUPERIORITY||Odds Ratio (OR)|0.24||||0.029|TWO_SIDED|95.0|0.07|0.86|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is reference group.|||.86|.07|.029
91628291|NCT01379924|183148140|SUPERIORITY||Odds Ratio (OR)|0.2||||0.017|TWO_SIDED|95.0|0.06|0.75|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is the reference group|||.75|.06|.017
91628292|NCT01379924|183148141|SUPERIORITY||Group by time interaction term coefficie|4.75|STANDARD_ERROR_OF_MEAN|3.84||0.217|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.217
91628293|NCT01379924|183148142|SUPERIORITY||Group by time interaction term coefficie|2.89|STANDARD_ERROR_OF_MEAN|3.77||0.444|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.444
91628294|NCT01379924|183148143|SUPERIORITY||Group by time interaction term coefficie|9.76|STANDARD_ERROR_OF_MEAN|3.82||0.011|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.011
91628295|NCT01379924|183148145|SUPERIORITY||Group by time interaction term coefficie|0.64|STANDARD_ERROR_OF_MEAN|0.59||0.758|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.758
91628296|NCT01379924|183148146|SUPERIORITY||Group by time interaction term coefficie|1.36|STANDARD_ERROR_OF_MEAN|0.6||0.024|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.024
91628297|NCT01379924|183148147|SUPERIORITY||Group by time interaction term coefficie|2.67|STANDARD_ERROR_OF_MEAN|2.88||0.354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up||||||.354
91628298|NCT01379924|183148148|SUPERIORITY||Group by time interaction term coefficie|4.43|STANDARD_ERROR_OF_MEAN|2.85||0.121|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.121
91628299|NCT01379924|183148149|SUPERIORITY||Group by time interaction term coefficie|3.67|STANDARD_ERROR_OF_MEAN|2.89||0.205|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.205
91628300|NCT01379924|183148150|SUPERIORITY||Group by time interaction term coefficie|0.65|STANDARD_ERROR_OF_MEAN|2.6||0.803|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.803
91714148|NCT01965327|183320104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|TWO_SIDED||||||t-test, 2 sided|Missing data were imputed by last observation carried forward.||||||0.027
91525464|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test.||||<0.001
91482786|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8825|TWO_SIDED|95.0|-0.27|0.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.23|-0.27|0.8825
91525465|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
91628301|NCT01379924|183148151|SUPERIORITY||Group by time interaction term coefficie|2.41|STANDARD_ERROR_OF_MEAN|2.56||0.347|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.347
91628302|NCT01379924|183148152|SUPERIORITY||Group by time interaction term coefficie|-1.39|STANDARD_ERROR_OF_MEAN|2.59||0.591|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.591
91628303|NCT02564029|183148181|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.86|-8.60|
91628304|NCT02564029|183148181|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.06|-7.78|
91628305|NCT02564029|183148181|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-2.84|-7.60|
91628306|NCT02564029|183148181|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||3.20|-1.58|
91628307|NCT02564029|183148181|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repreated Measure Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||1.41|-3.43|
91628308|NCT02564029|183148181|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||2.16|-2.56|
91628309|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measure Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.86|-8.60|
91628310|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.06|-7.78|
91628311|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-2.84|-7.60|
91628312|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||3.20|-1.58|
91628313|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.41|-3.43|
91664535|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.03|0.17||||||Change at Week 7, Speech||0.17|-0.03|
91525466|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Azathioprine: p-value was calculated using chi-square test.||||<0.001
91664536|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.095|||TWO_SIDED|90.0|-0.16|0.16||||||Change at Week 12, Speech||0.16|-0.16|
91664537|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|90.0|-0.04|0.22||||||Change at Week 12, Speech||0.22|-0.04|
91664538|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|-0.14|0.29||||||Change at Week 2, Right Finger to Finger Test||0.29|-0.14|
91664539|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|90.0|-0.22|0.14||||||Change at Week 2, Right Finger to Finger Test||0.14|-0.22|
91664540|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.13|0.28||||||Change at Week 7, Right Finger to Finger Test||0.28|-0.13|
91664541|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Right Finger to Finger Test||0.11|-0.24|
91664542|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126|||TWO_SIDED|90.0|-0.3|0.12||||||Change at Week 12, Right Finger to Finger Test||0.12|-0.30|
91664543|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.32|0.03||||||Change at Week 12, Right Finger to Finger Test||0.03|-0.32|
91664544|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|90.0|-0.15|0.33||||||Change at Week 2, Left Finger to Finger Test||0.33|-0.15|
91664545|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|90.0|-0.16|0.23||||||Change at Week 2, Left Finger to Finger Test||0.23|-0.16|
91664546|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|90.0|-0.18|0.23||||||Change at Week 7, Left Finger to Finger Test||0.23|-0.18|
91482787|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8791|TWO_SIDED|95.0|-0.28|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.24|-0.28|0.8791
91525467|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||<0.001
91525468|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||<0.001
91525469|NCT01557322|182926213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Leflunomide: p-value was calculated using chi-square test.||||<0.001
91525470|NCT01557322|182926214|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
91525471|NCT01557322|182926215|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline PCS: p-value was calculated using 2-sided t-test.||||<0.001
91664547|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.15|0.2||||||Change at Week 7, Left Finger to Finger Test||0.20|-0.15|
91664548|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|90.0|-0.17|0.36||||||Change at Week 12, Left Finger to Finger Test||0.36|-0.17|
91664549|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.13||||||Change at Week 12, Left Finger to Finger Test||0.13|-0.30|
91664550|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.04|0.53||||||Change at Week 2, Right Nose to Finger Test||0.53|0.04|
91664551|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|-0.06|0.33||||||Change at Week 2, Right Nose to Finger Test||0.33|-0.06|
91664552|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.22|0.37||||||Change at Week 7, Right Nose to Finger Test||0.37|-0.22|
91664553|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|90.0|-0.32|0.16||||||Change at Week 7, Right Nose to Finger Test||0.16|-0.32|
91664554|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.43|0.12||||||Change at Week 12, Right Nose to Finger Test||0.12|-0.43|
91664555|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.23|0.23||||||Change at Week 12, Right Nose to Finger Test||0.23|-0.23|
91664556|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.14|0.4||||||Change at Week 2, Left Nose to Finger Test||0.40|-0.14|
91664557|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.12|0.33||||||Change at Week 2, Left Nose to Finger Test||0.33|-0.12|
91664558|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|90.0|-0.09|0.43||||||Change at Week 7, Left Nose to Finger Test||0.43|-0.09|
91664559|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|90.0|-0.36|0.09||||||Change at Week 7, Left Nose to Finger Test||0.09|-0.36|
91664560|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|90.0|-0.29|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.29|
91664561|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.21|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.21|
91664562|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.33|0.26||||||Change at Week 2, Right Dysmetria Test||0.26|-0.33|
91664563|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|-0.12|0.36||||||Change at Week 2, Right Dysmetria Test||0.36|-0.12|
91664564|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.25|0.48||||||Change at Week 7, Right Dysmetria Test||0.48|-0.25|
91714149|NCT01965327|183320105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||t-test, 2 sided|||||||0.0078
91525472|NCT01557322|182926215|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||t-test, 2 sided|||Baseline MCS: p-value was calculated using 2-sided t-test.||||0.886
91664565|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.14|0.47||||||Change at Week 7, Right Dysmetria Test||0.47|-0.14|
91664566|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.26|0.48||||||Change at Week 12, Right Dysmetria Test||0.48|-0.26|
91664567|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.36|0.25||||||Change at Week 12, Right Dysmetria Test||0.25|-0.36|
91664568|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.185|||TWO_SIDED|90.0|-0.02|0.6||||||Change at Week 2, Left Dysmetria Test||0.60|-0.02|
91664569|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.1|0.41||||||Change at Week 2, Left Dysmetria Test||0.41|-0.10|
91714150|NCT02452047|183320107|OTHER|Difference in percentages|Difference in FOR %|-7.3|||||TWO_SIDED|90.0|-27.5|21.4|||||Stratified Miettinen \& Nurminen method by infection type|||21.4|-27.5|
91525473|NCT01557322|182926215|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||t-test, 2 sided|||Baseline Vitality Score: p-value was calculated using 2-sided t-test.||||0.680
91525474|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.0233|TWO_SIDED||||||Chi-squared|||Month 6: p-value was calculated using chi-square test.||||0.0233
91525475|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.5103|TWO_SIDED||||||Chi-squared|||Month 12: p-value was calculated using chi-square test.||||0.5103
91525476|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Chi-squared|||Month 18: p-value was calculated using chi-square test.||||0.9990
91628314|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||2.16|-2.56|
91628315|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-6.51|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|90.0|-8.01|-5.01|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-5.01|-8.01|
91628316|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-6.44|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-7.93|-4.95|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.95|-7.93|
91628317|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-7.2|-4.28|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.28|-7.20|
91628318|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-1.31|1.46|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.46|-1.31|
91628319|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-2.19|0.65|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.65|-2.19|
91628320|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-2.09|0.7|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.70|-2.09|
91664570|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|90.0|-0.63|0.13||||||Change at Week 7, Left Dysmetria Test||0.13|-0.63|
91664571|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.192|||TWO_SIDED|90.0|-0.47|0.18||||||Change at Week 7, Left Dysmetria Test||0.18|-0.47|
91664572|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.37|0.48||||||Change at Week 12, Left Dysmetria Test||0.48|-0.37|
91664573|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.11|0.58||||||Change at Week 12, Left Dysmetria Test||0.58|-0.11|
91664574|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.06|0.51||||||Change at Week 2, RAM of Right Hands||0.51|-0.06|
91664575|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.12|0.35||||||Change at Week 2, RAM of Right Hands||0.35|-0.12|
91664576|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|-0.41|0.28||||||Change at Week 7, RAM of Right Hands||0.28|-0.41|
91664577|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|90.0|-0.29|0.29||||||Change at Week 7, RAM of Right Hands||0.29|-0.29|
91664578|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.12|0.51||||||Change at Week 12, RAM of Right Hands||0.51|-0.12|
91664579|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.156|||TWO_SIDED|90.0|-0.31|0.21||||||Change at Week 12, RAM of Right Hands||0.21|-0.31|
91664580|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.15|0.32||||||Change at Week 2, RAM of Left Hands||0.32|-0.15|
91664581|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.12|0.27||||||Change at Week 2, RAM of Left Hands||0.27|-0.12|
91664582|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.27|0.43||||||Change at Week 7, RAM of Left Hands||0.43|-0.27|
91664583|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.17|0.42||||||Change at Week 7, RAM of Left Hands||0.42|-0.17|
91664584|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|90.0|0.04|0.58||||||Change at Week 12, RAM of Left Hand||0.58|0.04|
91664585|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|90.0|-0.01|0.43||||||Change at Week 12, RAM of Left Hand||0.43|-0.01|
91714151|NCT02452047|183320108|OTHER|Difference in percentages|Difference in AE %|-10.3|||||TWO_SIDED|95.0|-33.1|18.0|||||Miettinen \& Nurminen method|||18.0|-33.1|
91628321|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-5.6|-3.25|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.25|-5.60|
91628322|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.17|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.17|-5.57|
91628323|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.19|-5.57|
91628324|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.08|1.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.19|-1.08|
91628325|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.18|1.1|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.10|-1.18|
91628326|NCT02564029|183148182|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.11|1.13|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.13|-1.11|
91628327|NCT00617656|183148227|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.56|TWO_SIDED|95.0|0.76|1.67|||Log Rank|||This is a futility analysis. The initial hypothesis of the clinical trial was that the experimental group as a whole was superior to the control group.||1.67|0.76|0.56
91628328|NCT00617656|183148227|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.79|TWO_SIDED|95.0|0.73|1.51|||Log Rank|||||1.51|0.73|0.79
91628329|NCT00617656|183148227|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.0001|TWO_SIDED|95.0|1.38|2.95|||Log Rank|||||2.95|1.38|0.0001
91628330|NCT00617656|183148228|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.12|||Log Rank|||||2.12|1.13|0.006
91628331|NCT02579863|183148315|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.33475|TWO_SIDED|95.0|0.56|1.45|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).|||1.45|0.56|0.33475
91628332|NCT02579863|183148316|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.83416|TWO_SIDED|95.0|0.81|1.84|||Stratified log-rank test||"Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III)."|||1.84|0.81|0.83416
91628333|NCT02579863|183148317|SUPERIORITY||Difference in % vs SOC|5.8||||0.13102|TWO_SIDED|95.0|-4.3|15.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|||Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|15.8|-4.3|0.13102
91628334|NCT01224106|183148340|SUPERIORITY||Effect Size|-0.044||||0.6744|TWO_SIDED|95.0|-0.248|0.161|||Mixed Models Analysis|||||0.161|-0.248|0.6744
91628335|NCT01224106|183148340|SUPERIORITY||Effect Size|-0.085||||0.4494|TWO_SIDED|95.0|-0.304|0.135|||Mixed Models Analysis|||||0.135|-0.304|0.4494
91628336|NCT01224106|183148342|SUPERIORITY||Effect Size|0.035||||0.7458|TWO_SIDED|95.0|-0.179|0.25|||Mixed Models Analysis|||||0.250|-0.179|0.7458
91628337|NCT01224106|183148342|SUPERIORITY||Effect Size|0.042||||0.723|TWO_SIDED|95.0|-0.191|0.275|||Mixed Models Analysis|||||0.275|-0.191|0.723
91628338|NCT01224106|183148346|SUPERIORITY||Effect Size|-0.191||||0.0825|TWO_SIDED|95.0|-0.407|0.025|||Mixed Models Analysis|||||0.025|-0.407|0.0825
91628339|NCT01224106|183148346|SUPERIORITY||Effect Size|0.043||||0.7171|TWO_SIDED|95.0|-0.19|0.276|||Mixed Models Analysis|||||0.276|-0.19|0.7171
91628340|NCT01224106|183148349|SUPERIORITY|||||||0.9734|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.9734
91628341|NCT01224106|183148349|SUPERIORITY|||||||0.0629|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0629
91628342|NCT01224106|183148349|SUPERIORITY|||||||0.0084|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0084
91628343|NCT01224106|183148349|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0003
91628344|NCT01224106|183148349|SUPERIORITY|||||||0.0903|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0903
91628345|NCT01224106|183148349|SUPERIORITY|||||||0.0434|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0434
91664586|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|90.0|0.1|0.77||||||Change at Week 2, Right Finger Taps||0.77|0.10|
91664587|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|90.0|-0.12|0.44||||||Change at Week 2, Right Finger Taps||0.44|-0.12|
91664588|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.227|||TWO_SIDED|90.0|-0.16|0.6||||||Change at Week 7, Right Finger Taps||0.60|-0.16|
91664589|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.33|0.31||||||Change at Week 7, Right Finger Taps||0.31|-0.33|
91664590|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|90.0|-0.22|0.56||||||Change at Week 12, Right Finger Taps||0.56|-0.22|
91664591|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|90.0|-0.39|0.26||||||Change at Week 12, Right Finger Taps||0.26|-0.39|
91664592|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|90.0|0.12|0.87||||||Change at Week 2, Left Finger Taps||0.87|0.12|
91628346|NCT00446797|183148368|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than -10 mm.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|2.11||||95.0|-0.76|7.55|||ANCOVA|Terms for treatment, country (fixed), and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Least squares mean||7.55|-0.76|
91628347|NCT00446797|183148369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-0.89|7.08|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||7.08|-0.89|
91628348|NCT00446797|183148369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.04||||95.0|-0.55|7.48|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||7.48|-0.55|
91628349|NCT00446797|183148369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.86||||95.0|-0.91|6.42|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||6.42|-0.91|
91482788|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.8628|TWO_SIDED|95.0|-0.24|0.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.20|-0.24|0.8628
91482789|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7843|TWO_SIDED|95.0|-0.35|0.26||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.26|-0.35|0.7843
91482790|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0857|TWO_SIDED|95.0|-0.04|0.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.60|-0.04|0.0857
91664593|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.25|0.36||||||Change at Week 2, Left Finger Taps||0.36|-0.25|
91628350|NCT00446797|183148370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1591||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 2||||0.1591
91628351|NCT00446797|183148370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3995||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 3||||0.3995
91628352|NCT00446797|183148370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6805||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 7||||0.6805
91628353|NCT00446797|183148371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2411||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.2411
91628354|NCT00446797|183148371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1163||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.1163
91628355|NCT00446797|183148371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.0440
91628356|NCT00446797|183148372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7223||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.7223
91628357|NCT00446797|183148372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0541||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.0541
91628358|NCT00446797|183148373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 2||||0.2900
91628359|NCT00446797|183148373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.0157
91664594|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.218|||TWO_SIDED|90.0|0.22|0.95||||||Change at Week 7, Left Finger Taps||0.95|0.22|
91664595|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.15|0.47||||||Change at Week 7, Left Finger Taps||0.47|-0.15|
91664596|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|0.11|1.02||||||Change at Week 12, Left Finger Taps||1.02|0.11|
91664597|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.04|0.71||||||Change at Week 12, Left Finger Taps||0.71|-0.04|
91482791|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.3878|TWO_SIDED|95.0|-0.15|0.39||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.39|-0.15|0.3878
91482792|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8918|TWO_SIDED|95.0|-0.39|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.45|-0.39|0.8918
91482793|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.1233|TWO_SIDED|95.0|-0.09|0.76||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.76|-0.09|0.1233
91482794|NCT01227564|182839155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.3302|TWO_SIDED|95.0|-0.19|0.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.55|-0.19|0.3302
91482795|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65||||0.1597|TWO_SIDED|95.0|-0.67|3.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.97|-0.67|0.1597
91525477|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.6495|TWO_SIDED||||||Chi-squared|||Month 24: p-value was calculated using chi-square test.||||0.6495
91525478|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Month 30: p-value was calculated using chi-square test.||||0.3829
91525479|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.1085|TWO_SIDED||||||Chi-squared|||Month 36: p-value was calculated using chi-square test.||||0.1085
91664598|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.12|0.53||||||Change at Week 2, Right Heel Along Shin Slide||0.53|-0.12|
91664599|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.26|0.27||||||Change at Week 2, Right Heel Along Shin Slide||0.27|-0.26|
91664600|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|90.0|-0.56|0.28||||||Change at Week 7, Right Heel Along Shin Slide||0.28|-0.56|
91664601|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.53|0.19||||||Change at Week 7, Right Heel Along Shin Slide||0.19|-0.53|
91664602|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.12|0.78||||||Change at Week 12,Right Heel Along Shin Slide||0.78|-0.12|
91664603|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.226|||TWO_SIDED|90.0|-0.25|0.51||||||Change at Week 12,Right Heel Along Shin Slide||0.51|-0.25|
91664604|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.51|0.18||||||Change at Week 2, Left Heel Along Shin Slide||0.18|-0.51|
91664605|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.25|0.31||||||Change at Week 2, Left Heel Along Shin Slide||0.31|-0.25|
91664606|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.68|0.07||||||Change at Week 7, Left Heel Along Shin Slide||0.07|-0.68|
91664607|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|90.0|-0.48|0.15||||||Change at Week 7, Left Heel Along Shin Slide||0.15|-0.48|
91664608|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.45|0.4||||||Change at Week 12, Left Heel Along Shin Slide||0.40|-0.45|
91664609|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.34|0.36||||||Change at Week 12, Left Heel Along Shin Slide||0.36|-0.34|
91664610|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.1|0.53||||||Change at Week 2, Right Heel Along Shin Tap||0.53|-0.10|
91664611|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|0.17|0.69||||||Change at Week 2, Right Heel Along Shin Tap||0.69|0.17|
91664612|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|-0.72|0.19||||||Change at Week 7, Right Heel Along Shin Tap||0.19|-0.72|
91664613|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|90.0|-0.38|0.39||||||Change at Week 7, Right Heel Along Shin Tap||0.39|-0.38|
91628360|NCT00446797|183148373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1206||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.1206
91628361|NCT00446797|183148374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.0846
91628362|NCT00446797|183148374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3041||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.3041
91628363|NCT00446797|183148374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1216||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.1216
91628364|NCT00446797|183148375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.24||0.395||95.0|-0.33|0.62||Overall p-value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.33|0.395
91628365|NCT00446797|183148375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|0.18|1.04||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.04|0.18|0.004
91628366|NCT00446797|183148375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.22||0.122||95.0|-0.08|0.77||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.77|-0.08|0.122
91628367|NCT00446797|183148376|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.604||95.0|-0.32|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.49|-0.32|0.604
91628368|NCT00446797|183148376|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.18||0.124||95.0|-0.07|0.63||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.63|-0.07|0.124
91628369|NCT00446797|183148376|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.15||0.062||95.0|0.03|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|0.03|0.062
91628370|NCT00446797|183148377|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.21||0.705||95.0|-0.36|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.47|-0.36|0.705
91628371|NCT00446797|183148377|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.19||0.064||95.0|-0.01|0.73||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.73|-0.01|0.064
91628372|NCT00446797|183148377|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.074||95.0|-0.01|0.68||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.68|-0.01|0.074
91628373|NCT00446797|183148378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017||95.0|0.11|1.05||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||1.05|0.11|0.017
91628374|NCT00446797|183148378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.2||0.108||95.0|-0.05|0.74||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.74|-0.05|0.108
91628375|NCT00446797|183148378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.117||95.0|-0.01|0.66||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.66|-0.01|0.117
91628376|NCT00446797|183148379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.2||0.229||95.0|-0.17|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.17|0.229
91628377|NCT00446797|183148379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.18||0.027||95.0|0.05|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.75|0.05|0.027
91628378|NCT00446797|183148379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.07||95.0|0.01|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.65|0.01|0.070
91628379|NCT00446797|183148380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3||0.954||95.0|-0.64|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.53|-0.64|0.954
91628380|NCT00446797|183148380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.31||0.172||95.0|-0.19|1.02||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.02|-0.19|0.172
91628381|NCT00446797|183148380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.24||0.541||95.0|-0.3|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.62|-0.30|0.541
91628382|NCT00446797|183148381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.34||0.924||95.0|-0.75|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.58|-0.75|0.924
91628383|NCT00446797|183148381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.29||0.898||95.0|-0.62|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.62|0.898
91628384|NCT00446797|183148381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.24||0.655||95.0|-0.33|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.60|-0.33|0.655
91714152|NCT02452047|183320109|OTHER|Difference in percentages|Difference in SAE %|-21.6|||||TWO_SIDED|95.0|-47.8|1.3|||||Miettinen \& Nurminen method|||1.3|-47.8|
91664614|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|90.0|-0.23|0.51||||||Change at Week 12, Right Heel Along Shin Tap||0.51|-0.23|
91664615|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|0.02|0.64||||||Change at Week 12, Right Heel Along Shin Tap||0.64|0.02|
91714153|NCT02452047|183320110|OTHER|Difference in percentages|Difference in drug-related AE %|-15.1|||||TWO_SIDED|95.0|-42.3|9.2|||||Miettinen \& Nurminen method|||9.2|-42.3|
91714154|NCT02452047|183320111|OTHER|Difference in percentages|Difference in drug-related SAE %|0.0|||||TWO_SIDED|95.0|-19.7|11.2|||||Miettinen \& Nurminen method|||11.2|-19.7|
91628385|NCT00446797|183148382|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.929||95.0|-0.59|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.59|0.929
91628386|NCT00446797|183148382|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3||0.712||95.0|-0.5|0.71||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.71|-0.50|0.712
91628387|NCT00446797|183148382|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.993||95.0|-0.44|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.51|-0.44|0.993
91628388|NCT00446797|183148383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.32||0.779||95.0|-0.53|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.75|-0.53|0.779
91628389|NCT00446797|183148383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.972||95.0|-0.69|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.65|-0.69|0.972
91482796|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.213|TWO_SIDED|95.0|-4.01|0.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.91|-4.01|0.2130
91714155|NCT02452047|183320112|OTHER|Difference in percentages|Difference in discontinuation %|-18.8|||||TWO_SIDED|95.0|-43.3|-6.2|||||Miettinen \& Nurminen method|||-6.2|-43.3|
91664616|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|90.0|-0.17|0.5||||||Change at Week 2, Left Heel Along Shin Tap||0.50|-0.17|
91525480|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Chi-squared|||Month 48: p-value was calculated using chi-square test.||||0.0472
91628390|NCT00446797|183148383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.27||0.844||95.0|-0.47|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|-0.47|0.844
91628391|NCT00446797|183148384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.31||0.944||95.0|-0.63|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.63|0.944
91664617|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|90.0|0.06|0.61||||||Change at Week 2, Left Heel Along Shin Tap||0.61|0.06|
91664618|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|90.0|-0.09|0.84||||||Change at Week 7, Left Heel Along Shin Tap||0.84|-0.09|
91664619|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|-0.19|0.6||||||Change at Week 7, Left Heel Along Shin Tap||0.60|-0.19|
91664620|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.303|||TWO_SIDED|90.0|-0.2|0.82||||||Change at Week 12, Left Heel Along Shin Tap||0.82|-0.20|
91664621|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.17|0.67||||||Change at Week 12, Left Heel Along Shin Tap||0.67|-0.17|
91664622|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.5||||||Change at Week 2, Siting Posture||0.5|-0.1|
91525481|NCT01557322|182926225|SUPERIORITY_OR_OTHER|||||||0.4804|TWO_SIDED||||||Chi-squared|||Month 60: p-value was calculated using chi-square test.||||0.4804
91628392|NCT00446797|183148384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.654||95.0|-0.62|0.38||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.38|-0.62|0.654
91628393|NCT00446797|183148384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.952||95.0|-0.36|0.39||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.39|-0.36|0.952
91628394|NCT00446797|183148385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.842||95.0|-0.65|0.59||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.59|-0.65|0.842
91628395|NCT00446797|183148385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.828||95.0|-0.57|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.49|-0.57|0.828
91714156|NCT02452047|183320113|OTHER|Difference in percentages|Difference in drug-related discon %|-12.5|||||TWO_SIDED|95.0|-36.3|-0.3|||||Miettinen \& Nurminen method|||-0.3|-36.3|
91714157|NCT02452047|183320114|OTHER|Difference in percentages|Difference in pyrexia %|0.4|||||TWO_SIDED|95.0|-25.2|19.7|||||Miettinen \& Nurminen method|||19.7|-25.2|
91714158|NCT02452047|183320114|OTHER|Difference in percentages|Difference blood creatinine inc %|-25.0|||||TWO_SIDED|95.0|-49.8|-10.1|||||Miettinen \& Nurminen method|||-10.1|-49.8|
91714159|NCT02452047|183320115|OTHER|Difference in Category 1 ECI %|Difference in Category 1 ECI %|-12.5||||0.047|TWO_SIDED|95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
91714160|NCT02452047|183320115|OTHER|Difference in Category 2 ECI %|Difference in Category 2 ECI %|-12.5||||0.047||95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
91628396|NCT00446797|183148385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21||0.542||95.0|-0.3|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.53|-0.30|0.542
91664623|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.1|0.4||||||Change at Week 2, Siting Posture||0.4|-0.1|
91489386|NCT02484690|182851571|SUPERIORITY||Difference in Least Squares Means|-10.08||||0.3166|TWO_SIDED|80.0|-22.99|2.82||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.82|-22.99|0.3166
91628397|NCT00446797|183148386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.404||95.0|-0.92|0.42||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.42|-0.92|0.404
91628398|NCT00446797|183148386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.28||0.816||95.0|-0.53|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.58|-0.53|0.816
91628399|NCT00446797|183148386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.837||95.0|-0.37|0.52||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.52|-0.37|0.837
91628400|NCT00446797|183148387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.887||95.0|-0.54|0.45||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.45|-0.54|0.887
91628401|NCT00446797|183148387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.889||95.0|-0.43|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.43|0.889
91628402|NCT00446797|183148387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2||0.738||95.0|-0.3|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.47|-0.30|0.738
91628403|NCT00364832|183148388|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.81|||||TWO_SIDED|90.0|0.73|0.9|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ week (0.4, 0.8 and 1.2 dose group)||0.90|0.73|
91628404|NCT00364832|183148388|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.72|||||TWO_SIDED|90.0|0.55|0.86|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 3 weeks (0.4, 0.8 and 1.2 dose group)||0.86|0.55|
91628405|NCT00364832|183148388|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.93|||||TWO_SIDED|90.0|0.81|1.09|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group)||1.09|0.81|
91628406|NCT02580591|183148395|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|99.0|-0.46|-0.11|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.11|-0.46|<0.0001
91628407|NCT02580591|183148395|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.6|-0.3|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.30|-0.60|<0.0001
91628408|NCT02580591|183148395|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.68|-0.37|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.37|-0.68|<0.0001
91628409|NCT02580591|183148396|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.14|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.14|-0.40|
91664624|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Siting Posture||0.2|-0.4|
91664625|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 7, Siting Posture||0.5|0.0|
91664626|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, Siting Posture||0.2|-0.5|
91482797|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9616|TWO_SIDED|95.0|-2.06|2.16||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||2.16|-2.06|0.9616
91525482|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 6: p-value was calculated using chi-square test.||||0.0895
91628410|NCT02580591|183148396|SUPERIORITY||Median Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.59|-0.28|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.28|-0.59|<0.0001
91628411|NCT02580591|183148396|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.66|-0.35|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.35|-0.66|<0.0001
91628412|NCT02580591|183148397|SUPERIORITY||Adjusted Rate Ratio (%)|0.94|||||TWO_SIDED|95.0|0.673|1.314|||Negative binomial model||Empagliflozin 2.5 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.314|0.673|
91628413|NCT02580591|183148397|SUPERIORITY||Adjusted Rate Ratio (%)|1.202||||0.2752|TWO_SIDED|97.75|0.818|1.766|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.766|0.818|0.2752
91628414|NCT02580591|183148397|SUPERIORITY||Adjusted Rate Ratio (%)|1.02||||0.9077|TWO_SIDED|97.75|0.693|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.501|0.693|0.9077
91628415|NCT02580591|183148397|SUPERIORITY||Adjusted Rate Ratio (%)|0.932|||||TWO_SIDED|95.0|0.682|1.274|||Negative binomial model|||For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.274|0.682|
91664627|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.2|0.3||||||Change at Week 12, Siting Posture||0.3|-0.2|
91664628|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.4|0.4||||||Change at Week 2, SFA - TTA||0.4|-0.4|
91628416|NCT02580591|183148397|SUPERIORITY||Adjusted Rate Ratio (%)|1.258||||0.1438|TWO_SIDED|95.0|0.925|1.713||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.713|0.925|0.1438
91628417|NCT02580591|183148397|SUPERIORITY||Adjusted Rate Ratio (%)|1.051||||0.7543|TWO_SIDED|95.0|0.771|1.433||This is a nominal p-value.|Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.433|0.771|0.7543
91628418|NCT02580591|183148398|SUPERIORITY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-2.32|-1.2|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.20|-2.32|
91664629|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.3|0.3||||||Change at Week 2, SFA - TTA||0.3|-0.3|
91664630|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA - TTA||0.2|-0.4|
91664631|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 7, SFA - TTA||0.1|-0.5|
91664632|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.3|
91664633|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.2|
91525483|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0774|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 12: p-value was calculated using chi-square test.||||0.0774
91525484|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test.||||0.0024
91628419|NCT02580591|183148398|SUPERIORITY||Mean Difference (Final Values)|-3.04|||<|0.0001|TWO_SIDED|99.75|-3.91|-2.18|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.18|-3.91|<0.0001
91628420|NCT02580591|183148398|SUPERIORITY||Mean Difference (Final Values)|-3.43|||<|0.0001|TWO_SIDED|99.75|-4.3|-2.57|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.57|-4.30|<0.0001
91628421|NCT02580591|183148399|SUPERIORITY||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.069|-0.03|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.030|-0.069|
91628422|NCT02580591|183148399|SUPERIORITY||Mean Difference (Final Values)|-0.07|||<|0.0001|TWO_SIDED|99.75|-0.101|-0.039|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.039|-0.101|<0.0001
91628423|NCT02580591|183148399|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|99.75|-0.122|-0.06|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.060|-0.122|<0.0001
91664634|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.1|0.3||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.3|-0.1|
91664635|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.1|-0.2|
91664636|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.2|-0.4|
91664637|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.4|0.1||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.1|-0.4|
91628424|NCT02580591|183148400|SUPERIORITY||Median Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.9|-0.2|||Mixed effect Model Repeat MeasurementMix||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.2|-3.9|
91664638|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.4|-0.3|
91664639|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.1|-0.5|
91664640|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.8|0.2||||||Change at Week 2, SFT - TTA||0.2|-0.8|
91664641|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.0|0.8||||||Change at Week 2, SFT - TTA||0.8|0.0|
91525485|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test.||||0.5552
91525486|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test.||||0.0793
91664642|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 7, SFT - TTA||0.4|-0.3|
91664643|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.2|0.7||||||Change at Week 7, SFT - TTA||0.7|0.2|
91664644|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, SFT - TTA||0.2|-0.5|
91664645|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.0|0.7||||||Change at Week 12, SFT - TTA||0.7|0.0|
91664646|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
91664647|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
91664648|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.2|
91664649|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.1|
91628425|NCT02580591|183148400|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.0001|TWO_SIDED|99.75|-6.8|-1.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, , treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.1|-6.8|<0.0001
91628426|NCT02580591|183148400|SUPERIORITY||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|99.75|-6.6|-0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.9|-6.6|<0.0001
91628427|NCT02580591|183148400|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.5|0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.9|-1.5|
91628428|NCT02580591|183148400|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0047|TWO_SIDED|99.75|-3.6|0.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.1|-3.6|0.0047
91628429|NCT02580591|183148400|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0202|TWO_SIDED|99.75|-3.3|0.4|||Mixed effect Model Repeat Measurement|||For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.4|-3.3|0.0202
91628430|NCT01366534|183148407|OTHER||Vaccine Efficacy Maentel-Haenzel Method|-17.6||||0.7675|TWO_SIDED|95.0|-107.4|33.3|||2-sided Fisher Exact test||Pre-defined futility criteria for efficacy: point estimate of increase of VE in Ad35.CS.01 Group over GSK257049 Group less than 0%|Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||33.3|-107.4|0.7675
91664650|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.2|-0.2|
91664651|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.0|-0.3|
91525487|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test.||||0.0075
91525488|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test.||||0.0895
91628431|NCT01366534|183148407|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|44.0||||0.0066|TWO_SIDED|95.0|20.7|60.4|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||60.4|20.7|0.0066
91628432|NCT01366534|183148407|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|52.4||||0.0021|TWO_SIDED|95.0|25.4|69.6|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||69.6|25.4|0.0021
91628433|NCT00324272|183148459|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||t-test, 2 sided|||||||0.704
91628434|NCT00324272|183148459|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||t-test, 2 sided|||||||0.217
91628435|NCT00324272|183148461|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
91628436|NCT00324272|183148461|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
91628437|NCT00324272|183148462|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Fisher Exact|||||||0.351
91628438|NCT00324272|183148462|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||||||0.480
91664652|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.2|
91664653|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.1|
91664654|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.0||||||Change at Week 7, Tandem Stance - TTA||0.0|-0.2|
91664655|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, Tandem Stance - TTA||0.2|-0.1|
91664656|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Stance - TTA||0.1|-0.2|
91664657|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 12, Tandem Stance - TTA||0.2|-0.1|
91482798|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2143|TWO_SIDED|95.0|-1.06|4.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||4.62|-1.06|0.2143
91664658|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
91664659|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
91664660|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.2|
91664661|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.1|
91482799|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.2151|TWO_SIDED|95.0|-4.87|1.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.12|-4.87|0.2151
91482800|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.9704|TWO_SIDED|95.0|-2.61|2.51||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.51|-2.61|0.9704
91525489|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test.||||0.0024
91525490|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.6301|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test.||||0.6301
91525491|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test.||||0.0793
91664662|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, Tandem Walk||0.0|-0.3|
91664663|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Walk||0.1|-0.2|
91525492|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test.||||0.0075
91664664|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 2, Gait||0.4|-0.2|
91664665|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.1|0.7||||||Change at Week 2, Gait||0.7|0.1|
91664666|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Gait||0.2|-0.4|
91664667|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.1|0.6||||||Change at Week 7, Gait||0.6|0.1|
91664668|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 12, Gait||0.2|-0.4|
91664669|NCT03214588|183222793|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 12, Gait||0.5|0.0|
91664670|NCT03214588|183222794|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.889||0.599|TWO_SIDED|90.0|-1.31|1.76||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.76|-1.31|0.599
91664671|NCT03214588|183222794|SUPERIORITY||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.625||0.978|TWO_SIDED|90.0|0.26|2.42||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||2.42|0.26|0.978
91664672|NCT03214588|183222794|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.14||0.533|TWO_SIDED|90.0|-1.87|2.06||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.06|-1.87|0.533
91664673|NCT03214588|183222794|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.886||0.37|TWO_SIDED|90.0|-1.83|1.23||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.23|-1.83|0.370
91664674|NCT03214588|183222794|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.078||0.972|TWO_SIDED|90.0|0.32|4.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.04|0.32|0.972
91664675|NCT03214588|183222794|SUPERIORITY||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.819||0.825|TWO_SIDED|90.0|-0.63|2.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||2.19|-0.63|0.825
91714161|NCT02452047|183320116|OTHER|Difference in percentages|Difference in nephrotoxicity %|-45.9||||0.002||95.0|-69.1|-18.4|||Fisher Exact||Miettinen \& Nurminen method|||-18.4|-69.1|0.002
91714162|NCT02452047|183320117|OTHER|Difference in Day 28 FCR %|Difference in Day 28 FCR %|26.3|||||TWO_SIDED|90.0|1.3|51.5|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.5|1.3|
91482801|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.7857|TWO_SIDED|95.0|-3.0|3.95||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||3.95|-3.00|0.7857
91628439|NCT00324272|183148463|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91628440|NCT00324272|183148463|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.400
91628441|NCT00324272|183148464|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||1.00
91628442|NCT00324272|183148464|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Fisher Exact|||In transit or regional recurrence in the groin cohort.||||0.301
91628443|NCT00324272|183148464|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.474
91628444|NCT00324272|183148464|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||0.606
91628445|NCT00324272|183148464|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||In transit or regional recurrence in the axillary cohort.||||1.000
91628446|NCT00324272|183148464|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.486
91628447|NCT00324272|183148465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.963|TWO_SIDED|95.0|0.4|2.58|||Regression, Cox|||Death from metastatic disease in the groin cohort.||2.58|0.40|0.963
91628448|NCT00324272|183148465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.338|TWO_SIDED|95.0|0.03|3.2|||Regression, Cox|||Death from an unrelated cause in the groin cohort.||3.20|0.03|0.338
91628449|NCT00324272|183148465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.88|TWO_SIDED|95.0|0.35|2.47|||Regression, Cox|||Death from metastatic disease in the axillary cohort.||2.47|0.35|0.880
91628450|NCT00324272|183148465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.923||||0.923|TWO_SIDED|95.0|0.05|13.95|||Regression, Cox|||Death from an unrelated cause in the axillary cohort.||13.95|0.05|0.923
91628451|NCT04882072|183148466|SUPERIORITY||Hazard Ratio (HR)|1.86|||||TWO_SIDED|95.0|0.41|8.47||||||||8.47|0.41|
91628452|NCT02918318|183148487|SUPERIORITY||Difference of Least Squares means|-1.0|STANDARD_ERROR_OF_MEAN|2.25||0.475|TWO_SIDED|90.0|-5.77|3.7||1-sided|Dunnett adjustment|||||3.70|-5.77|0.475
91628453|NCT02918318|183148487|SUPERIORITY||Difference of Least Squares means|0.6|STANDARD_ERROR_OF_MEAN|2.33||0.504|TWO_SIDED|90.0|-4.32|5.47||1-sided|Dunnett adjustment|||||5.47|-4.32|0.504
91628454|NCT02918318|183148487|SUPERIORITY||Difference of Least Squares means|-0.9|STANDARD_ERROR_OF_MEAN|2.26||0.482|TWO_SIDED|90.0|-5.66|3.83||1-sided|Dunnett adjustment|||||3.83|-5.66|0.482
91628455|NCT01548417|183148501|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Linear Mixed Effects Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in alcohol-cued craving..||||.003
91628456|NCT01548417|183148502|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Linear Mixed Effect Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in changes in drinking.||||.05
91628457|NCT01548417|183148502|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Data represent the estimated marginal mean + or - SEM. \*P\<0.05, mifepristone vs. placebo (linear mixed effects modeling).||||<0.05
91628458|NCT04583969|183148504|SUPERIORITY||Odds Ratio (OR)|1.13||||0.691|TWO_SIDED|95.0|0.63|2.02|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||2.02|0.63|0.691
91628459|NCT04583969|183148505|SUPERIORITY||Odds Ratio (OR)|1.24||||0.378|TWO_SIDED|95.0|0.77|1.99|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||1.99|0.77|0.378
91628460|NCT04583969|183148506|SUPERIORITY|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline CRP.|Hazard Ratio, log|0.96||||0.689|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|||1.20|0.76|0.689
91628461|NCT04583969|183148507|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.718|TWO_SIDED|95.0|0.79|1.18|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal Score, age, and baseline CRP.||1.18|0.79|0.718
91628462|NCT04583969|183148508|SUPERIORITY||Odds Ratio (OR)|1.02||||0.907|TWO_SIDED|95.0|0.75|1.39|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Lenzilumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.39|0.75|0.907
91628463|NCT04583969|183148542|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.609|TWO_SIDED|95.0|0.87|1.27|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.27|0.87|0.609
91628464|NCT04583969|183148543|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.708|TWO_SIDED|95.0|0.85|1.26|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.26|0.85|0.708
91714163|NCT02452047|183320118|OTHER|Difference in mortality %|Difference in mortality %|-17.3|||||TWO_SIDED|90.0|-46.4|6.7|||||Miettinen and Nurminen method stratified by infection-site stratum|||6.7|-46.4|
91525493|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.7253|TWO_SIDED||||||Chi-squared|||Myeloma, Month 12: p-value was calculated using chi-square test.||||0.7253
91525494|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.7336|TWO_SIDED||||||Chi-squared|||Myeloma, Month 30: p-value was calculated using chi-square test.||||0.7336
91628465|NCT04080752|183148545|SUPERIORITY||Least Square (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.897||0.2494|TWO_SIDED|80.0|-1.76|0.55|||Mixed Model for Repeated Measures (MMRM)|||||0.55|-1.76|0.2494
91628466|NCT00444080|183148558|OTHER|||||||0.013|||||||Fisher Exact|||||||0.013
91628467|NCT01641081|183148667|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2644|STANDARD_ERROR_OF_MEAN|0.0148|<|0.0001|TWO_SIDED|95.0|0.2353|0.2934|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2934|0.2353|<0.0001
91628468|NCT01641081|183148667|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2524|STANDARD_ERROR_OF_MEAN|0.0156|<|0.0001|TWO_SIDED|95.0|0.2218|0.283|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2830|0.2218|<0.0001
91628469|NCT01641081|183148667|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2242|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1941|0.2544|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2544|0.1941|<0.0001
91628470|NCT01641081|183148667|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2174|STANDARD_ERROR_OF_MEAN|0.0146|<|0.0001|TWO_SIDED|95.0|0.1887|0.2461|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2461|0.1887|<0.0001
91628471|NCT01095666|183148669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.0869|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.42|-0.76|<0.0001
91628472|NCT01095666|183148669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.0865|<|0.0001|TWO_SIDED|95.0|-0.79|-0.45||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.45|-0.79|<0.0001
91628473|NCT01095666|183148670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|3.299|<|0.0001|TWO_SIDED|95.0|-28.6|-15.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-15.6|-28.6|<0.0001
91628474|NCT01095666|183148670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.1|STANDARD_ERROR_OF_MEAN|3.271|<|0.0001|TWO_SIDED|95.0|-33.5|-20.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-20.7|-33.5|<0.0001
91628475|NCT01095666|183148671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|5.8758|<|0.0001|TWO_SIDED|95.0|-53.84|-30.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-30.73|-53.84|<0.0001
91628476|NCT01095666|183148671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.1|STANDARD_ERROR_OF_MEAN|5.7921|<|0.0001|TWO_SIDED|95.0|-60.53|-37.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-37.74|-60.53|<0.0001
91628477|NCT01095666|183148672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2765|<|0.0001|TWO_SIDED|95.0|-1.65|-0.56||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-0.56|-1.65|<0.0001
91628478|NCT01095666|183148672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.2747|<|0.0001|TWO_SIDED|95.0|-2.36|-1.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-1.28|-2.36|<0.0001
91628479|NCT01095666|183148673|SUPERIORITY_OR_OTHER||Difference in percentage|15.4|STANDARD_ERROR_OF_MEAN|4.702||0.001|TWO_SIDED|95.0|6.2|24.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.7|6.2|0.0010
91628480|NCT01095666|183148673|SUPERIORITY_OR_OTHER||Difference in percentage|15.5|STANDARD_ERROR_OF_MEAN|4.594||0.0007|TWO_SIDED|95.0|6.5|24.5||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.5|6.5|0.0007
91525495|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED||||||Chi-squared|||Leukaemia, Month 12: p-value was calculated using chi-square test.||||0.0044
91628481|NCT02809846|183148684|OTHER|Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.|||||<|0.05||||||Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.|Mixed Models Analysis|Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.||Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05|Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike's Information Criteria to determine optimal covariance structure.|||<0.05
91628482|NCT00166517|183148690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed versus a constant, 85%, based on historical data.||||||0.003||95.0||||p ≥.85, where p is the proportion of subjects who achieved ≥3-fold rise from baseline in the group that received RotaTeq®|Exact test of proportion|Exact test of proportion, based on binomial distribution||||||0.003
91628483|NCT04018612|183148753|SUPERIORITY||LS Mean Difference|-21.84|STANDARD_ERROR_OF_MEAN|11.091||0.0258|ONE_SIDED|90.0||-7.53|||ANCOVA||SPID24 was analyzed using ANCOVA model with treatment group as a fixed effect and baseline (BL) Pain Intensity-Numerical Pain Relief Scale (PI-NPRS) as a covariate. The lower limit of one-sided 90% confidence interval (CI) was -∞|||-7.53||0.0258
91628484|NCT04018612|183148753|SUPERIORITY||LS Mean Difference|-25.74|STANDARD_ERROR_OF_MEAN|11.154||0.0115|ONE_SIDED|90.0||-11.35|||ANCOVA||SPID24 was analyzed using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The lower limit of one-sided 90% CI was -∞|||-11.35||0.0115
91482802|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.1323|TWO_SIDED|95.0|-6.45|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-6.45|0.1323
91525496|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.4175|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test.||||0.4175
91628485|NCT04018612|183148754|SUPERIORITY||LS Mean Difference|12.72|STANDARD_ERROR_OF_MEAN|5.267||0.0087|ONE_SIDED|90.0|5.92||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.92|0.0087
91628486|NCT04018612|183148754|SUPERIORITY||LS Mean Difference|12.14|STANDARD_ERROR_OF_MEAN|5.297||0.012|ONE_SIDED|90.0|5.31||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.31|0.0120
91628487|NCT01041404|183148814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||||0.85|0.59|0.0002
91628488|NCT01041404|183148816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.85|||Log Rank|||||0.85|0.58|0.0003
91628489|NCT01041404|183148817|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.8||||0.0017|TWO_SIDED|95.0|4.7|20.9|||Chi-squared|||||20.9|4.7|0.0017
91628490|NCT01041404|183148819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73|||Log Rank|||||0.73|0.40|<0.0001
91628491|NCT01041404|183148820|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|9.6||||0.0081|TWO_SIDED|95.0|2.4|16.9|||Chi-squared|||||16.9|2.4|0.0081
91628492|NCT01041404|183148820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66|||||TWO_SIDED|95.0|1.14|2.41||||||||2.41|1.14|
91628493|NCT01041404|183148821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0046|TWO_SIDED|95.0|0.6|0.91|||Log Rank|||||0.91|0.60|0.0046
91628494|NCT02483078|183148837|SUPERIORITY|||||||0.0032|||||||Fisher Exact|The Fisher's Exact test if the count in any cell was less than 5; otherwise Chi-Square test was to be used||||||.0032
91664676|NCT03214588|183222795|SUPERIORITY||Least Squares Mean Difference|0.045|STANDARD_ERROR_OF_MEAN|0.23858||0.426|TWO_SIDED|90.0|-0.3665|0.4565||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.4565|-0.3665|0.426
91664677|NCT03214588|183222795|SUPERIORITY||Least Squares Mean Difference|-0.3281|STANDARD_ERROR_OF_MEAN|0.15794||0.975|TWO_SIDED|90.0|-0.6005|-0.0557||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.0557|-0.6005|0.975
91664678|NCT03214588|183222795|SUPERIORITY||Least Squares Mean Difference|0.1448|STANDARD_ERROR_OF_MEAN|0.31186||0.324|TWO_SIDED|90.0|-0.3931|0.6826||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.6826|-0.3931|0.324
91664679|NCT03214588|183222795|SUPERIORITY||Least Squares Mean Difference|0.0113|STANDARD_ERROR_OF_MEAN|0.23213||0.481|TWO_SIDED|90.0|-0.3891|0.4117||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.4117|-0.3891|0.481
91525497|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.3886|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test.||||0.3886
91628495|NCT02483078|183148838|SUPERIORITY|||||||0.0377|||||||Fisher Exact|||||||.0377
91628496|NCT02483078|183148839|SUPERIORITY|||||||0.1201|||||||Fisher Exact|||||||.1201
91628497|NCT02483078|183148840|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||.0013
91628498|NCT02483078|183148844|SUPERIORITY|||||||0.7123|||||||ANCOVA|||The raw and change from baseline in CD4 cell count at the end of the 1-week double blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.||||.7123
91628499|NCT02483078|183148846|SUPERIORITY|||||||0.0993|||||||Fisher Exact|||||||.0993
91628500|NCT01962688|183148857|OTHER|||||||0.002|||||||Chi-squared|||||||0.002
91628501|NCT02712008|183148865|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|-2.09||||0.1368|TWO_SIDED|95.0||0.67||Threshold for significance at 0.05 level.|ANCOVA|||||0.67|- 4.84|0.1368
91628502|NCT02712008|183148865|SUPERIORITY||Least square mean difference|0.04||||0.9716|TWO_SIDED|95.0||2.18||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.18|- 2.10|0.9716
91628503|NCT02712008|183148866|SUPERIORITY||Least square mean difference|2.15||||0.1665|TWO_SIDED|95.0|-0.9|5.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.20|-0.90|0.1665
91664680|NCT03214588|183222795|SUPERIORITY||Least Squares Mean Difference|-0.2067|STANDARD_ERROR_OF_MEAN|0.28088||0.765|TWO_SIDED|90.0|-0.6911|0.2778||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.2778|-0.6911|0.765
91664681|NCT03214588|183222795|SUPERIORITY||Least Squares Mean Difference|0.1173|STANDARD_ERROR_OF_MEAN|0.19778||0.28|TWO_SIDED|90.0|-0.2238|0.4585||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.4585|-0.2238|0.280
91664682|NCT03214588|183222796|SUPERIORITY||Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.28||0.735|TWO_SIDED|90.0|-9.9|4.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.4|-9.9|0.735
91714164|NCT02452047|183320119|OTHER|Adjusted difference in OTX FCR %|Adjusted difference in OTX FCR %|33.9|||||TWO_SIDED|90.0|7.4|61.1|||||Miettinen and Nurminen method stratified by infection-site stratum|||61.1|7.4|
91714165|NCT02452047|183320120|OTHER|Adjusted difference in EOT FCR %|Adjusted difference in EOT FCR %|25.4|||||TWO_SIDED|90.0|3.1|53.6|||||Miettinen and Nurminen method stratified by infection-site stratum|||53.6|3.1|
91714166|NCT02452047|183320121|OTHER|Adjusted difference in EFU FCR %|Difference in EFU FCR %|24.7|||||TWO_SIDED|90.0|3.8|51.4|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.4|3.8|
91714167|NCT02452047|183320122|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
91628504|NCT02712008|183148866|SUPERIORITY||Least square mean difference|1.9||||0.2223|TWO_SIDED|95.0|-1.16|4.95||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.95|-1.16|0.2223
91628505|NCT02712008|183148866|SUPERIORITY||Least square mean difference|0.39||||0.7943|TWO_SIDED|95.0|-2.54|3.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.32|-2.54|0.7943
91628506|NCT02712008|183148866|SUPERIORITY||Least square mean difference|0.66||||0.6655|TWO_SIDED|95.0|-2.35|3.67||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.67|-2.35|0.6655
91628507|NCT02712008|183148866|SUPERIORITY||Least square mean difference|2.33||||0.1278|TWO_SIDED|95.0|-0.67|5.33||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.33|-0.67|0.1278
91628508|NCT02712008|183148866|SUPERIORITY||Least square mean difference|-1.51||||0.3159|TWO_SIDED|-1.51|-4.47|1.45||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.45|-4.47|0.3159
91628509|NCT02712008|183148866|SUPERIORITY||Least square mean difference|-0.27||||0.8537|TWO_SIDED|95.0|-3.18|2.63||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.63|-3.18|0.8537
91628510|NCT02712008|183148867|SUPERIORITY||Least square mean difference|-24.43||||0.1105|TWO_SIDED|95.0|-54.46|5.61||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||5.61|-54.46|0.1105
91628511|NCT02712008|183148867|SUPERIORITY||Least square mean difference|-27.79||||0.0183|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||- 4.74|- 50.83|0.0183
91628512|NCT02712008|183148868|SUPERIORITY||Least square mean difference|-55.91||||0.004|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||- 18.01|- 93.81|0.0040
91628513|NCT02712008|183148868|SUPERIORITY||Least square mean difference|-40.51||||0.0365|TWO_SIDED|95.0|-78.46|-2.57||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.57|-78.46|0.0365
91628514|NCT02712008|183148868|SUPERIORITY||Least square mean difference|-37.15||||0.0454|TWO_SIDED|95.0|-73.53|-0.77||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.77|-73.53|0.0454
91714168|NCT02452047|183320123|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
91714169|NCT02452047|183320124|OTHER|Difference in percentages|Difference in FMR %|-27.3|||||TWO_SIDED|90.0|-52.8|12.8|||||Miettinen \& Nurminen method|||12.8|-52.8|
91628515|NCT02712008|183148868|SUPERIORITY||Least square mean difference|1.75||||0.9266|TWO_SIDED|95.0|-35.54|39.03||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||39.03|-35.54|0.9266
91628516|NCT02712008|183148868|SUPERIORITY||Least square mean difference|-15.49||||0.4116|TWO_SIDED|95.0|-52.58|21.59||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||21.59|-52.58|0.4116
91628517|NCT02712008|183148868|SUPERIORITY||Least square mean difference|3.36||||0.8574|TWO_SIDED|95.0|-33.42|40.14||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||40.14|-33.42|0.8574
91628518|NCT02712008|183148868|SUPERIORITY||Least square mean difference|-38.9||||0.0351|TWO_SIDED|95.0|-75.06|-2.73||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.73|-75.06|0.0351
91628519|NCT02712008|183148869|SUPERIORITY||difference in percentages|-1.8||||0.7617|TWO_SIDED|95.0|-13.5|9.8||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||9.8|-13.5|0.7617
91714170|NCT02185417|183320133|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.45|TWO_SIDED|95.0|0.94|1.16|||Log Rank|||Primary analyses were performed with the use of unadjusted log-rank tests that were stratified according to VA health care system.||1.16|0.94|0.45
91714171|NCT03843372|183320161|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The AHI was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare AHI between CPAP and HFNC||||<0.001
91714172|NCT03843372|183320162|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The oxygen desaturation index was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare oxygen desaturation index between CPAP and HFNC||||<0.001
91482803|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.4618|TWO_SIDED|95.0|-4.29|1.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.97|-4.29|0.4618
91482804|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.2622|TWO_SIDED|95.0|-1.74|6.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.22|-1.74|0.2622
91628520|NCT02712008|183148869|SUPERIORITY||difference in percentages|6.1||||0.2268|TWO_SIDED|95.0||16.3||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||16.3|- 4.1|0.2268
91628521|NCT02712008|183148870|SUPERIORITY||difference in percentages|-1.3||||0.8896|TWO_SIDED|95.0|-20.4|17.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||17.7|-20.4|0.8896
91628522|NCT02712008|183148870|SUPERIORITY||difference in percentages|6.4||||0.5021|TWO_SIDED|95.0|-12.6|25.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||25.5|-12.6|0.5021
91628523|NCT02712008|183148870|SUPERIORITY||difference in percentages|6.0||||0.5273|TWO_SIDED|95.0|-12.8|24.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||24.7|-12.8|0.5273
91628524|NCT02712008|183148870|SUPERIORITY||difference in percentages|-1.5||||0.8683|TWO_SIDED|95.0|-19.7|16.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||16.6|-19.7|0.8683
91628525|NCT02712008|183148870|SUPERIORITY||difference in percentages|8.8||||0.3546|TWO_SIDED|95.0|-9.8|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.8|0.3546
91628526|NCT02712008|183148870|SUPERIORITY||difference in percentages|0.2||||0.9801|TWO_SIDED|95.0|-19.0|19.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||19.5|-19.0|0.9801
91628527|NCT02712008|183148870|SUPERIORITY||difference in percentages|8.8||||0.3528|TWO_SIDED|95.0|-9.9|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.9|0.3528
91628528|NCT02436915|183148916|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TUG (i.e., greater percent decrease of time to complete TUG from baseline to follow ups) as compared to the sham tDCS.||||||0.24|||||||ANOVA|||||||0.24
91628529|NCT02436915|183148917|EQUIVALENCE|We hypothesized that the real tDCS would improve the MoCA score (i.e., greater percent increase decrease of MoCA score from baseline to follow ups) as compared to the sham tDCS.||||||0.03|||||||ANOVA|||||||0.03
91628530|NCT02436915|183148918|EQUIVALENCE|We hypothesized that the real tDCS would improve the dual task performance of walking (i.e., greater percent decrease of dual task cost to walking speed from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
91628531|NCT02436915|183148919|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing sway speed from baseline to follow ups) as compared to the sham tDCS.||||||0.004|||||||ANOVA|||||||0.004
91628532|NCT02436915|183148920|EQUIVALENCE|We hypothesized that the real tDCS would reduce the depression (i.e., greater percent decrease of GDS score from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
91628533|NCT02436915|183148921|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TMT (i.e., greater percent decrease of time to complete TMT from baseline to follow ups) as compared to the sham tDCS.||||||0.54|||||||ANOVA|||||||0.54
91628534|NCT02436915|183148922|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing postural sway area from baseline to follow ups) as compared to the sham tDCS.||||||0.0007|||||||ANOVA|||||||0.0007
91628535|NCT02436915|183148923|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of walking (i.e., greater percent decrease of dual task cost to stride time from baseline to follow ups) as compared to the sham tDCS.||||||0.04|||||||ANOVA|||||||0.04
91628536|NCT03805971|183148924|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||"The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0003
91628537|NCT03805971|183148924|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
91628538|NCT03805971|183148924|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||"The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0052
91664683|NCT03214588|183222796|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.51||0.182|TWO_SIDED|90.0|-2.7|9.1||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||9.1|-2.7|0.182
91482805|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.4499|TWO_SIDED|95.0|-5.64|2.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.55|-5.64|0.4499
91525498|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.5102|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test.||||0.5102
91664684|NCT03214588|183222796|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.59||0.97|TWO_SIDED|90.0|-12.9|-0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||-0.9|-12.9|0.970
91664685|NCT03214588|183222796|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|3.0||0.321|TWO_SIDED|90.0|-3.6|6.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||6.4|-3.6|0.321
91664686|NCT03214588|183222796|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.34||0.905|TWO_SIDED|90.0|-13.0|1.5||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.5|-13.0|0.905
91664687|NCT03214588|183222796|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.57||0.199|TWO_SIDED|90.0|-2.9|9.0||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||9.0|-2.9|0.199
91664688|NCT03214588|183222797|SUPERIORITY|||||||0.974||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.974
91664689|NCT03214588|183222797|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.893
91664690|NCT03214588|183222797|SUPERIORITY|||||||0.954||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.954
91664691|NCT03214588|183222797|SUPERIORITY|||||||0.793||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.793
91664692|NCT03214588|183222797|SUPERIORITY|||||||0.845||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.845
91664693|NCT03214588|183222797|SUPERIORITY|||||||0.816||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.816
91664694|NCT03214588|183222798|SUPERIORITY|||||||0.84||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.840
91664695|NCT03214588|183222798|SUPERIORITY|||||||0.854||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.854
91664696|NCT03214588|183222798|SUPERIORITY|||||||0.922||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.922
91664697|NCT03214588|183222798|SUPERIORITY|||||||0.794||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.794
91664698|NCT03214588|183222798|SUPERIORITY|||||||0.83||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.830
91664699|NCT03214588|183222798|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
91525499|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.9855|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test.||||0.9855
91664700|NCT03214588|183222799|SUPERIORITY|||||||0.987||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.987
91664701|NCT03214588|183222799|SUPERIORITY|||||||0.771||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.771
91664702|NCT03214588|183222799|SUPERIORITY|||||||0.526||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.526
91664703|NCT03214588|183222799|SUPERIORITY|||||||0.665||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.665
91664704|NCT03214588|183222799|SUPERIORITY|||||||0.576||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.576
91664705|NCT03214588|183222799|SUPERIORITY|||||||0.865||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.865
91525500|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.4955|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test.||||0.4955
91664706|NCT03214588|183222800|SUPERIORITY|||||||0.966||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.966
91664707|NCT03214588|183222800|SUPERIORITY|||||||0.983||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.983
91482806|NCT01227564|182839156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.8454|TWO_SIDED|95.0|-3.21|3.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.91|-3.21|0.8454
91664708|NCT03214588|183222800|SUPERIORITY|||||||0.953||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.953
91664709|NCT03214588|183222800|SUPERIORITY|||||||0.781||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.781
91664710|NCT03214588|183222800|SUPERIORITY|||||||0.948||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.948
91664711|NCT03214588|183222800|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
91664712|NCT03214588|183222801|SUPERIORITY|||||||0.666||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.666
91664713|NCT03214588|183222801|SUPERIORITY|||||||0.812||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.812
91664714|NCT03214588|183222801|SUPERIORITY|||||||0.834||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.834
91664715|NCT03214588|183222801|SUPERIORITY|||||||0.841||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.841
91664716|NCT03214588|183222801|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.893
91664717|NCT03214588|183222801|SUPERIORITY|||||||0.907||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.907
91664718|NCT03214588|183222802|SUPERIORITY|||||||0.032||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.032
91664719|NCT03214588|183222802|SUPERIORITY|||||||0.216||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.216
91664720|NCT03214588|183222802|SUPERIORITY|||||||0.215||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.215
91664721|NCT03214588|183222802|SUPERIORITY|||||||0.411||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.411
91714173|NCT03843372|183320163|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The total sleep time was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare total sleep time between CPAP and HFNC||||<0.001
91664722|NCT03214588|183222802|SUPERIORITY|||||||0.194||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.194
91664723|NCT03214588|183222802|SUPERIORITY|||||||0.408||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.408
91664724|NCT03214588|183222803|SUPERIORITY|||||||0.406||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.406
91664725|NCT03214588|183222803|SUPERIORITY|||||||0.235||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.235
91664726|NCT03214588|183222803|SUPERIORITY|||||||0.225||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.225
91664727|NCT03214588|183222803|SUPERIORITY|||||||0.434||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.434
91664728|NCT03214588|183222803|SUPERIORITY|||||||0.249||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.249
91664729|NCT03214588|183222803|SUPERIORITY|||||||0.38||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.380
91664730|NCT03214588|183222804|SUPERIORITY|||||||0.422||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.422
91664731|NCT03214588|183222804|SUPERIORITY|||||||0.226||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.226
91664732|NCT03214588|183222804|SUPERIORITY|||||||0.639||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.639
91664733|NCT03214588|183222804|SUPERIORITY|||||||0.094||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.094
91664734|NCT03214588|183222804|SUPERIORITY|||||||0.516||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.516
91664735|NCT03214588|183222804|SUPERIORITY|||||||0.266||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.266
91664736|NCT03214588|183222805|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.362||0.299|TWO_SIDED|90.0|-0.8|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.41|-0.80|0.299
91664737|NCT03214588|183222805|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.293||0.967|TWO_SIDED|90.0|0.06|1.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.04|0.06|0.967
91664738|NCT03214588|183222805|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.338||0.529|TWO_SIDED|90.0|-0.54|0.59||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.59|-0.54|0.529
91664739|NCT03214588|183222805|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.279||0.88|TWO_SIDED|90.0|-0.13|0.8||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.80|-0.13|0.880
91664740|NCT03214588|183222805|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.408||0.599|TWO_SIDED|90.0|-0.58|0.79||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.79|-0.58|0.599
91664741|NCT03214588|183222805|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.333||0.846|TWO_SIDED|90.0|-0.21|0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.90|-0.21|0.846
91664742|NCT03214588|183222806|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
91664743|NCT03214588|183222806|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
91664744|NCT03214588|183222806|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
91664745|NCT03214588|183222806|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
91664746|NCT03503318|183222827|OTHER||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.109|0.367||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.367|0.109|<0.0001
91664747|NCT03503318|183222827|OTHER||Hazard Ratio (HR)|0.375|||<|0.0001|TWO_SIDED|95.0|0.227|0.618||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.618|0.227|<0.0001
91664748|NCT00112437|183222872|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.5|||<=|0.001|TWO_SIDED|95.0|2.54|4.45||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||4.45|2.54|<=0.001
91664749|NCT00112437|183222872|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.78|||<=|0.001|TWO_SIDED|95.0|1.82|3.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||3.73|1.82|<=0.001
91664750|NCT00112437|183222872|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.63||||0.003|TWO_SIDED|95.0|0.68|2.59||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||2.59|0.68|0.003
91691964|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.12||0.0416||95.0|0.01|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 2||0.50|0.01|0.0416
91691965|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1819||95.0|-0.1|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 3||0.50|-0.10|0.1819
91482807|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.1796|TWO_SIDED|95.0|-0.18|0.96||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.96|-0.18|0.1796
91628539|NCT03805971|183148924|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
91628540|NCT01585168|183148994|OTHER||Mean Difference (Net)|2.4109||||0.032|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided|A Paired t-test was performed to explore the difference between two groups.|FHN was found to have lower mean BOLD activation while given drug compared to placebo in amygdala.|||||0.032
91628541|NCT01585168|183148994|OTHER||Median Difference (Net)|3.6615||||0.125|TWO_SIDED||||||t-test, 2 sided|||||||0.125
91628542|NCT01585168|183148997|OTHER||Mean Difference (Net)|2.7264||||0.356|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided||FHP was found to have lower mean BOLD activation while given drug compared to placebo in anterior cingulate cortex.|||||0.356
91628543|NCT01585168|183148997|OTHER||Median Difference (Net)|1.8348||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
91628544|NCT02057068|183149002|SUPERIORITY||||||<|0.001|||||||ANOVA|Intention to treat analysis with last observation carried forward|||Partial Eta Squared = .282|||<.001
91482808|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.7281|TWO_SIDED|95.0|-0.49|0.69||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.69|-0.49|0.7281
91628545|NCT02057068|183149003|SUPERIORITY|Intention to treat analysis with last observation carried forward|||||>|0.05|||||||ANOVA|||||||>.05
91628546|NCT02057068|183149004|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91628547|NCT01704976|183149007|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91628548|NCT01704976|183149008|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91628549|NCT01704976|183149009|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91628550|NCT01704976|183149010|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91628551|NCT01704976|183149011|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91628552|NCT00329784|183149012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91628553|NCT00329784|183149012|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
91628554|NCT00329784|183149013|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91628555|NCT00329784|183149014|SUPERIORITY_OR_OTHER|||||||0.369|||||||Wilcoxon (Mann-Whitney)|||||||0.369
91628556|NCT00329784|183149015|SUPERIORITY_OR_OTHER|||||||0.642|||||||Chi-squared|||||||0.642
91628557|NCT00329784|183149016|SUPERIORITY_OR_OTHER|||||||0.417|||||||Chi-squared|||Comparison for Seasonal Rhinoconjunctivitis||||0.417
91628558|NCT00329784|183149016|SUPERIORITY_OR_OTHER|||||||0.926|||||||Chi-squared|||Comparison for Perennial Rhinoconjunctivitis||||0.926
91628559|NCT00329784|183149017|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison for Peanut Wheal||||<0.001
91628560|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.361|||||||Chi-squared|||Comparison for Egg Wheal||||0.361
91628561|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Comparison for Milk Wheal||||0.760
91628562|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.834|||||||Chi-squared|||Comparison for Sesame Wheal||||0.834
91628563|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.882|||||||Chi-squared|||Comparison for Brazil Nut Wheal||||0.882
91628564|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.226|||||||Chi-squared|||Comparison for Hazel Nut Wheal||||0.226
91628565|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||Comparison for Cashew Wheal||||0.024
91628566|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.204|||||||Chi-squared|||Comparison for Walnut Wheal||||0.204
91628567|NCT00329784|183149017|SUPERIORITY_OR_OTHER|||||||0.194|||||||Chi-squared|||Comparison for Almond Wheal||||0.194
91628568|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.859|||||||Chi-squared|||Comparison for Peanut IgE||||0.859
91628569|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.885|||||||Chi-squared|||Comparison for Egg IgE||||0.885
91628570|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.403|||||||Chi-squared|||Comparison for Milk IgE||||0.403
91628571|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.106|||||||Chi-squared|||Comparison for Sesame IgE||||0.106
91628572|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.202|||||||Chi-squared|||Comparison for Brazil Nut IgE||||0.202
91628573|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||Comparison for Hazel Nut IgE||||0.108
91628574|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.157|||||||Chi-squared|||Comparison for Cashew IgE||||0.157
91628575|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||Comparison for Walnut IgE||||0.040
91628576|NCT00329784|183149018|SUPERIORITY_OR_OTHER|||||||0.262|||||||Chi-squared|||Comparison for Almond IgE||||0.262
91628577|NCT00588380|183149023|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Kruskal-Wallis|||Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was \<0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.||||0.11
91482809|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.3347|TWO_SIDED|95.0|-0.26|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.75|-0.26|0.3347
91525501|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.5404|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test.||||0.5404
91525502|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.3581|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test.||||0.3581
91628578|NCT00588380|183149024|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Kruskal-Wallis|||All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal||||0.09
91628579|NCT05563714|183149043|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.41|11.33|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Includes clinician proceduralist vs non-proceduralist status as a co-variate.||11.33|2.41|<0.001
91628580|NCT05563714|183149043|SUPERIORITY||Odds Ratio (OR)|5.76|||<|0.001|TWO_SIDED|95.0|2.54|13.05|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||13.05|2.54|<0.001
91628581|NCT05563714|183149044|SUPERIORITY||Odds Ratio (OR)|29.3|||<|0.001|TWO_SIDED|95.0|6.07|141.49|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Included clinician proceduralist vs non-proceduralist status as a co-variate.||141.49|6.07|<0.001
91628582|NCT05563714|183149044|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|6.56|289.88|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||289.88|6.56|<0.001
91628583|NCT05563714|183149045|SUPERIORITY|Adjusted OR, 95% CI (base model) - Included clinician proceduralist vs non-proceduralist status as a co-variate.|Odds Ratio, log|19.86|||<|0.001|TWO_SIDED|95.0|10.63|29.09|||generalized linear mixed effects model|||We used generalized linear mixed effects modeling (logit link) to estimate the odds of medication optimization at week 7-10. This model included fixed effects for CNNF (vs. usual care), target provider specialty and size, and a random effect for clinician to account for the clustering of patients. We report the log odds ratios with corresponding confidence intervals for the main effect. The main effect was tested at a two-sided 5% significance level.||29.09|10.63|<0.001
91628584|NCT01262599|183149046|SUPERIORITY|Applies to primary and secondary outcomes: Data were analyzed using one-way analysis of variance, one-way repeated measures analysis of variance, t test, or Mann-Whitney rank sum test, as appropriate. (SigmaStat 3.5; Systat Software, Inc., San Jose, Calif.). Intention-to-treat using last value carried forward was used for missing data.|||||<|0.01|||||||ANOVA|||Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.||||<0.01
91628585|NCT02427100|183149049|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANCOVA|||||||.18
91628586|NCT02427100|183149050|SUPERIORITY_OR_OTHER|||||||0.00036||||||The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.|Mixed Models Analysis|A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.||||||.00036
91664751|NCT00112437|183222872|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.49||||0.343|TWO_SIDED|95.0|-1.44|0.46||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||0.46|-1.44|0.343
91664752|NCT00112437|183222873|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.67|||<=|0.001|TWO_SIDED|95.0|4.32|7.02||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||7.02|4.32|<=0.001
91628587|NCT02120352|183149059|OTHER||Difference in Percentage|3.7|||||TWO_SIDED|95.0|-4.8|12.2|||||Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD|||12.2|-4.8|
91525503|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.4932|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 6: p-value was calculated using chi-square test.||||0.4932
91525504|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.4818|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 12: p-value was calculated using chi-square test.||||0.4818
91628588|NCT02120352|183149059|OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-5.8|11.5|||||Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD|||11.5|-5.8|
91628589|NCT00444964|183149124|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91628590|NCT00444964|183149125|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91628591|NCT00444964|183149126|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91628592|NCT02573233|183149139|SUPERIORITY|||||||0.84||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.8400
91482810|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.3425|TWO_SIDED|95.0|-0.43|1.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.20|-0.43|0.3425
91482811|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4501|TWO_SIDED|95.0|-1.16|0.52||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.52|-1.16|0.4501
91482812|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.9227|TWO_SIDED|95.0|-0.68|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.75|-0.68|0.9227
91525505|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 18: p-value was calculated using chi-square test.||||0.3224
91525506|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.5003|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 24: p-value was calculated using chi-square test.||||0.5003
91525507|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.1134|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 30: p-value was calculated using chi-square test.||||0.1134
91525508|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.3488|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 36: p-value was calculated using chi-square test.||||0.3488
91525509|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 48: p-value was calculated using chi-square test.||||0.1870
91628593|NCT02573233|183149140|SUPERIORITY||LS Mean Difference|-235.02||||0.0336|TWO_SIDED|90.0|-414.19|-55.84||Threshold for significance at 0.05 level|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||-55.84|-414.19|0.0336
91628594|NCT02573233|183149141|SUPERIORITY||LS mean difference|13.89||||0.4795|TWO_SIDED|90.0|-19.0|46.78||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||46.78|-19.00|0.4795
91628595|NCT02573233|183149142|SUPERIORITY||LS mean difference|-18.98||||0.4494|TWO_SIDED|90.0|-60.92|22.97||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||22.97|-60.92|0.4494
91664753|NCT00112437|183222873|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.45|||<=|0.001|TWO_SIDED|95.0|3.15|5.76||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||5.76|3.15|<=0.001
91525510|NCT01557322|182926226|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 60: p-value was calculated using chi-square test.||||0.4270
91628596|NCT02573233|183149143|SUPERIORITY|||||||0.6865||||||Threshold for significance at 0.05 level.|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.6865
91628597|NCT02573233|183149144|SUPERIORITY|||||||0.7588||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.7588
91628598|NCT02573233|183149145|SUPERIORITY||LS Mean Difference|-22.4||||0.0012|TWO_SIDED|90.0|-32.9|-11.9||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect Model with Repeated Measures (MRMM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-11.9|-32.9|0.0012
91525511|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.5817|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 6: p-value was calculated using chi-square test.||||0.5817
91525512|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.2595|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 12: p-value was calculated using chi-square test.||||0.2595
91628599|NCT02573233|183149146|SUPERIORITY||LS Mean Difference|-22.0||||0.0005|TWO_SIDED|90.0|-31.3|-12.8||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect model with Repeated Measures (MMRM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-12.8|-31.3|0.0005
91628600|NCT00249795|183149152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.857|TWO_SIDED|95.0|0.907|1.085||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 4.5% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.085|0.907|0.8570
91628601|NCT00249795|183149153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.12|TWO_SIDED|95.0|0.869|1.016||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 1% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.016|0.869|0.1200
91628602|NCT00249795|183149154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916||||0.2162|TWO_SIDED|95.0|0.796|1.053||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of a stroke in Irbesartan group versus Placebo group.|||1.053|0.796|0.2162
91628603|NCT00249795|183149155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.759|TWO_SIDED|95.0|0.927|1.11||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of death in Irbesartan group versus Placebo group.|||1.110|0.927|0.7590
91628604|NCT00249795|183149156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.0369|TWO_SIDED|95.0|0.809|0.993||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of HF episodes in Irbesartan group versus Placebo group.|||0.993|0.809|0.0369
91628605|NCT00249795|183149157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.0175|TWO_SIDED|95.0|0.763|0.975||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for Heart Failure in Irbesartan group versus Placebo group.|||0.975|0.763|0.0175
91628606|NCT00249795|183149158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.8377|TWO_SIDED|95.0|0.93|1.093||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for other CV cause in Irbesartan group versus Placebo group.|||1.093|0.930|0.8377
91628607|NCT05103475|183149159|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's exact due to small cell sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||||||1.0
91628608|NCT05103475|183149160|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.35|||||||t-test, 2 sided|||||||0.35
91525513|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.5642|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 18: p-value was calculated using chi-square test.||||0.5642
91628609|NCT05103475|183149161|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||||||0.15
91628610|NCT05103475|183149162|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.43|||||||t-test, 2 sided|||Pre/post comparison for control group scores.||||0.43
91628611|NCT05103475|183149162|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.24|||||||t-test, 2 sided|||Pre/post comparison for RAP group score.||||0.24
91628612|NCT05103475|183149162|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.53||||||F = 0.41|ANOVA|||ANOVA results - group x time interaction.||||0.53
91628613|NCT05103475|183149163|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.7|||||||t-test, 2 sided|||Pre/post comparison for control group.||||0.70
91628614|NCT05103475|183149163|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.17|||||||t-test, 2 sided|||Pre/post comparison for RAP group.||||0.17
91628615|NCT05103475|183149163|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.18||||||F = 1.95|ANOVA|||ANOVA results - group x time interaction.||||0.18
91628616|NCT05103475|183149164|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.37|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.37
91691966|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0331||95.0|0.03|0.7|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 4||0.70|0.03|0.0331
91691967|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0608||95.0|-0.02|0.83|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 5||0.83|-0.02|0.0608
91525514|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 24: p-value was calculated using chi-square test.||||0.0034
91525515|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.7137|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 36: p-value was calculated using chi-square test.||||0.7137
91628617|NCT05103475|183149164|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.50
91628618|NCT05103475|183149164|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.9||||||F = 0.01|ANOVA|||ANOVA results - group x time interaction.||||0.90
91628619|NCT05103475|183149165|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.56|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.56
91628620|NCT05103475|183149165|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.32|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.32
91628621|NCT05103475|183149165|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41||||||F = 0.71|ANOVA|||ANOVA results - group x time interaction.||||0.41
91628622|NCT05103475|183149166|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.50
91628623|NCT05103475|183149166|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.6|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.60
91628624|NCT05103475|183149166|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.98||||||F = 0.0|ANOVA|||ANOVA results - group x time interaction.||||0.98
91664754|NCT00112437|183222873|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.39|||<=|0.001|TWO_SIDED|95.0|2.06|4.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||4.73|2.06|<=0.001
91691968|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.33||0.2809||95.0|-0.31|1.03|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 6||1.03|-0.31|0.2809
91525516|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.963|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 60: p-value was calculated using chi-square test.||||0.9630
91628625|NCT05103475|183149167|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.54|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.54
91691969|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.32||0.3445||95.0|-0.34|0.95|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 7||0.95|-0.34|0.3445
91525517|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.7353|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test.||||0.7353
91525518|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test.||||0.3829
91628626|NCT05103475|183149167|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.15
91628627|NCT05103475|183149167|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.04||||||F = 4.9|ANOVA|||ANOVA results - group x time interaction.||||0.04
91628628|NCT05103475|183149168|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.11|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.11
91628629|NCT05103475|183149168|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.09|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.09
91628630|NCT05103475|183149168|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.75||||||F = 0.10|ANOVA|||ANOVA results - group x time interaction.||||0.75
91628631|NCT05103475|183149169|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41|||||||Fisher Exact|The investigators used Fisher's Exact due to small cell sizes.||Likelihood to participate in a program like it in the future||||0.41
91628632|NCT05103475|183149169|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.003||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Help to manage back pain.||||0.003
91628633|NCT05103475|183149169|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's Exact due to small sample sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||Would recommend to another Veteran.||||1.00
91628634|NCT05103475|183149169|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.07||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Liked the program.||||0.07
91628635|NCT05103475|183149170|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.91|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.91
91628636|NCT05103475|183149170|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.51|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.51
91628637|NCT05103475|183149170|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.42||||||F = 0.68|ANOVA|||ANOVA results - group x time interaction.||||0.42
91628638|NCT02228824|183149171|SUPERIORITY||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.86|2.17|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||2.17|0.86|<0.001
91628639|NCT02228824|183149173|SUPERIORITY||Mean Difference (Final Values)|-38.5||||0.041|TWO_SIDED|95.0|-75.21|-1.78|||Mixed Models Analysis|||||-1.78|-75.21|0.041
91628640|NCT02228824|183149174|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.016|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||-0.13|-1.26|0.016
91628641|NCT02228824|183149175|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002|||Mixed Models Analysis|||||-0.002|-0.04|0.03
91628642|NCT02917629|183149211|SUPERIORITY||Mean Difference (Final Values)|1.0011|STANDARD_DEVIATION|0.024||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000229822 baseline and post exposure||||0.031
91628643|NCT02917629|183149211|SUPERIORITY||Mean Difference (Final Values)|-1.0217|STANDARD_DEVIATION|0.0257||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000230585 baseline and post exposure||||0.031
91628644|NCT02917629|183149211|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post exposure||||<0.001
91628645|NCT02917629|183149211|SUPERIORITY||Mean Difference (Final Values)|1.0007|STANDARD_DEVIATION|0.0063|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000261792 baseline and post exposure||||<0.001
91628646|NCT02917629|183149212|SUPERIORITY||Mean Difference (Final Values)|1.006|STANDARD_DEVIATION|0.006||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000234806 baseline and post exposure||||0.002
91628647|NCT02917629|183149213|SUPERIORITY||Mean Difference (Final Values)|1.0013|STANDARD_DEVIATION|0.0072||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000232479 baseline and post exposure||||0.002
91628648|NCT02917629|183149213|SUPERIORITY||Mean Difference (Final Values)|1.0037|STANDARD_DEVIATION|0.0193||0.02|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000233163 baseline and post exposure||||0.020
91628649|NCT02917629|183149213|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post-exposure||||0.001
91628650|NCT01042938|183149227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7991|STANDARD_DEVIATION|0.7606||0.0077|TWO_SIDED|95.0|-1.3693|-0.2289|||Standard pooled variances t-test|||Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.||-0.2289|-1.3693|0.0077
91628651|NCT01042938|183149228|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.||||0.0022
91628652|NCT01042938|183149229|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||ANOVA|||Hypothesis: There is a significant difference in mean redness (i.e., mean a\* number value) between the curcumin and placebo groups.||||0.145
91628653|NCT01042938|183149230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.685||||0.218|TWO_SIDED|95.0|-1.059|4.428|||ANCOVA|||Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.||4.428|-1.059|0.218
91628654|NCT01042938|183149230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.152|TWO_SIDED|95.0|-0.6|3.6|||ANCOVA|||Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.||3.6|-0.6|0.152
91628655|NCT01042938|183149230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7|TWO_SIDED|95.0|-0.7|1.1|||ANCOVA|||Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.||1.1|-0.7|0.700
91628656|NCT01042938|183149230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.559|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.||0.7|-0.4|0.559
91628657|NCT03136484|183149231|NON_INFERIORITY|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.|Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
91628658|NCT03136484|183149231|SUPERIORITY||Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
91628659|NCT00360685|183149292|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Sample size was based on the difference in the proportion of patients in each arm who were predicted to develop severe mucositis defined as clinical grade 3 or 4 per the CTCAE. A sample-size of 42 evaluable subjects per study-arm allowed detection of an absolute difference of 30%, which corresponds to a reduction in the incidence of severe mucositis from 60% in the methotrexate arm to 30% in the MMF arm (alpha=0.05, power=0.80).||||0.06
91628660|NCT00360685|183149293|SUPERIORITY_OR_OTHER|||||||0.8|||||||K-sample tests for comparing the cumulat|||||||0.8
91628661|NCT00360685|183149294|SUPERIORITY_OR_OTHER|||||||0.58|||||||Log Rank|||||||0.58
91628662|NCT01203787|183149308|SUPERIORITY_OR_OTHER|||||||0.0262|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.0262
91628663|NCT03061812|183149315|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0051|TWO_SIDED|95.0|1.17|1.82|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.82|1.17|0.0051
91628664|NCT03061812|183149316|SUPERIORITY||Hazard Ratio (HR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.22|1.87|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.87|1.22|< 0.0001
91691970|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.47||0.2806||95.0|-0.44|1.46|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 8||1.46|-0.44|0.2806
91691971|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.49||0.5217||95.0|-0.68|1.33|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 9||1.33|-0.68|0.5217
91628665|NCT03061812|183149317|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|-5.66|4.65||||||||4.65|-5.66|
91628666|NCT03061812|183149318|SUPERIORITY||Odds Ratio (OR)|0.68||||0.3352|TWO_SIDED|95.0|0.39|1.18|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.18|0.39|0.3352
91628667|NCT03061812|183149319|SUPERIORITY||Odds Ratio (OR)|0.73||||0.0358|TWO_SIDED|95.0|0.47|1.12|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.12|0.47|0.0358
91482813|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.345|TWO_SIDED|95.0|-0.51|1.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.45|-0.51|0.3450
91628668|NCT00431496|183149321|SUPERIORITY_OR_OTHER||Percentage of participants|42.3||||||95.0|30.8|53.7||||||||53.7|30.8|
91628669|NCT00431496|183149322|SUPERIORITY_OR_OTHER||Percentage of participants|52.1||||||95.0|40.5|63.7||||||||63.7|40.5|
91628670|NCT00431496|183149323|SUPERIORITY_OR_OTHER||Percentage of participants|78.9||||||95.0|69.4|88.4||||||||88.4|69.4|
91628671|NCT00431496|183149324|SUPERIORITY_OR_OTHER||Percentage of participants|54.9||||||95.0|43.4|66.5||||||||66.5|43.4|
91628672|NCT00431496|183149325|SUPERIORITY_OR_OTHER||Percentage of participants|53.5||||||95.0|41.9|65.1||||||||65.1|41.9|
91664755|NCT00112437|183222873|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.84||||0.218||95.0|-2.19|0.51||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||0.51|-2.19|0.218
91664756|NCT00112437|183222874|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.49|||<=|0.001|TWO_SIDED|95.0|1.62|3.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||3.35|1.62|<=0.001
91664757|NCT00112437|183222874|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.06|||<=|0.001|TWO_SIDED|95.0|1.2|2.93||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.93|1.20|<=0.001
91664758|NCT00112437|183222874|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.67|||<=|0.001|TWO_SIDED|95.0|0.8|2.53||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.53|0.80|<=0.001
91691972|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.34||0.3628||95.0|-0.37|1.0|||ANCOVA|||Parethesia/Dysesthesia Pain LOCF Endpoint||1.00|-0.37|0.3628
91628673|NCT00431496|183149326|SUPERIORITY_OR_OTHER||Percentage of participants|46.5||||||95.0|34.9|58.1||||||||58.1|34.9|
91628674|NCT02999191|183149327|OTHER||Ratio|89.9|STANDARD_DEVIATION|36.0|||TWO_SIDED|90.0|73.304|110.25|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The Standard Deviation \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.25|73.304|
91628675|NCT02999191|183149327|OTHER||Ratio|170.78|STANDARD_DEVIATION|33.9|||TWO_SIDED|90.0|139.85|208.54|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.54|139.85|
91628676|NCT02999191|183149328|OTHER||Ratio|84.17|STANDARD_DEVIATION|48.8|||TWO_SIDED|90.0|64.26|110.24|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.24|64.260|
91525519|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.4532|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test.||||0.4532
91664759|NCT00112437|183222874|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.75||||0.135|TWO_SIDED|95.0|-1.61|0.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||0.11|-1.61|0.135
91628677|NCT02999191|183149328|OTHER||Ratio|136.16|STANDARD_DEVIATION|54.8|||TWO_SIDED|90.0|99.885|185.61|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||185.61|99.885|
91664760|NCT00112437|183222875|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.66|||<=|0.001|TWO_SIDED|95.0|1.71|3.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||3.61|1.71|<=0.001
91664761|NCT00112437|183222875|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.89|||<=|0.001|TWO_SIDED|95.0|0.93|2.84||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||2.84|0.93|<=0.001
91664762|NCT00112437|183222875|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.87||||0.095|TWO_SIDED|95.0|-0.09|1.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||1.82|-0.09|0.095
91628678|NCT02566109|183149348|OTHER|Estimation of Pearson correlation|Pearson Correlation Coefficient|-0.57472||||0.6102|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.6102
91628679|NCT02566109|183149348|OTHER|Correlation|Pearson Correlation Coefficient|0.25733||||0.8343|TWO_SIDED||||||Peason Correlation Coefficient|||Correlation between baseline and 6 months.||||0.8343
91628680|NCT02566109|183149349|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|-0.09487||||0.9395|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9395
91628681|NCT02566109|183149349|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.97287||||0.1486|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.1486
91628682|NCT02566109|183149350|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.10327||||0.9341|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9341
91628683|NCT02566109|183149350|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.99696||||0.0497|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.0497
91628684|NCT02566109|183149351|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.98432||||0.1129|TWO_SIDED||||||Pearson Correlation Coefficient|||||||0.1129
91628685|NCT01685203|183149365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381|TWO_SIDED||||||Regression, Logistic|Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors||||||0.381
91628686|NCT01685203|183149365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086|TWO_SIDED|||||Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.|Stratum-adjusted Mantel-Haenszel|||||||0.086
91628687|NCT01602549|183149379|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.965|||||TWO_SIDED|95.0|0.831|1.12|||||Day 1: The adjusted means (AMs) and ratios were estimated using a mixed model (MM) fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 1||1.120|0.831|
91628688|NCT01602549|183149379|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.886|||||TWO_SIDED|95.0|0.763|1.029|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 8||1.029|0.763|
91628689|NCT01602549|183149379|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.937|||||TWO_SIDED|95.0|0.85|1.033|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8: Day 1||1.033|0.850|
91482814|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.274|TWO_SIDED|95.0|-1.58|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.45|-1.58|0.2740
91482815|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.914|TWO_SIDED|95.0|-0.92|0.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.82|-0.92|0.9140
91525520|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.4238|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test.||||0.4238
91664763|NCT00112437|183222875|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.19|||||TWO_SIDED|95.0|-1.14|0.75|||ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||0.75|-1.14|
91664764|NCT00112437|183222876|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.94|||<=|0.001|TWO_SIDED|95.0|1.64|4.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||4.24|1.64|<=0.001
91664765|NCT00112437|183222876|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.65|||<=|0.001|TWO_SIDED|95.0|1.35|3.94||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.94|1.35|<=0.001
91664766|NCT00112437|183222876|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.38|||<=|0.001|TWO_SIDED|95.0|1.08|3.69||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.69|1.08|<=0.001
91664767|NCT00112437|183222876|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.29||||0.731|TWO_SIDED|95.0|-1.58|1.0||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||1.00|-1.58|0.731
91664768|NCT00112437|183222877|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.29||||0.112|TWO_SIDED|95.0|-0.77|1.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||1.35|-0.77|0.112
91691973|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.3557||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 2||0.01|-0.00|0.3557
91691974|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.2824||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 3||0.01|-0.00|0.2824
91691975|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5931||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 4||0.01|-0.01|0.5931
91691976|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.9865||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 5||0.01|-0.01|0.9865
91525521|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.1218|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test.||||0.1218
91482816|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.0923|TWO_SIDED|95.0|-0.18|2.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.24|-0.18|0.0923
91525522|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.4124|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test.||||0.4124
91664769|NCT00112437|183222877|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.09|||||TWO_SIDED|95.0|-1.13|0.95||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.95|-1.13|
91664770|NCT00112437|183222877|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.63|||||TWO_SIDED|95.0|-1.69|0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.42|-1.69|
91664771|NCT00112437|183222877|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47|||||TWO_SIDED|95.0|-2.53|-0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||-0.42|-2.53|
91664772|NCT00112437|183222878|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.23|||<=|0.001|TWO_SIDED|95.0|0.22|2.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.24|0.22|<=0.001
91664773|NCT00112437|183222878|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.1||||0.005|TWO_SIDED|95.0|0.09|2.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.11|0.09|0.005
91525523|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.6356|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test.||||0.6356
91664774|NCT00112437|183222878|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.27||||0.63|TWO_SIDED|95.0|-0.74|1.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||1.29|-0.74|0.630
91664775|NCT00112437|183222878|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27|||||TWO_SIDED|95.0|-2.28|-0.27||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||-0.27|-2.28|
91691977|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9854||95.0|-0.02|0.02|||ANCOVA|||Total Score Cycle 6||0.02|-0.02|0.9854
91691978|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3403||95.0|-0.01|0.04|||ANCOVA|||Total Score Cycle 7||0.04|-0.01|0.3403
91691979|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2226||95.0|-0.01|0.05|||ANCOVA|||Total Score Cycle 8||0.05|-0.01|0.2226
91628690|NCT01602549|183149379|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8:Day 1 Placebo||1.170|0.890|
91664776|NCT00112437|183222879|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-57.86|||<=|0.001|TWO_SIDED|95.0|-72.33|-43.38||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-43.38|-72.33|<=0.001
91664777|NCT00112437|183222879|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-45.92|||<=|0.001|TWO_SIDED|95.0|-60.93|-30.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-30.91|-60.93|<=0.001
91664778|NCT00112437|183222879|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-31.84|||<=|0.001|TWO_SIDED|95.0|-48.11|-15.58||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-15.58|-48.11|<=0.001
91664779|NCT00112437|183222879|SUPERIORITY_OR_OTHER||Difference in Least Square Means|11.17||||0.249|TWO_SIDED|95.0|-0.94|43.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||43.24|-0.94|0.249
91664780|NCT00112437|183222880|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-56.33|||<=|0.001||95.0|-75.86|-36.81||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-36.81|-75.86|<=0.001
91664781|NCT00112437|183222880|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.57|||<=|0.001||95.0|-56.63|-14.51||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Square Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-14.51|-56.63|<=0.001
91664782|NCT00112437|183222880|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.66||||0.08||95.0|-44.54|1.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||1.23|-44.54|0.080
91628691|NCT01602549|183149381|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.864|||||TWO_SIDED|95.0|0.702|1.064|||||Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||1.064|0.702|
91628692|NCT01602549|183149381|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.824|1.257|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||1.257|0.824|
91628693|NCT01602549|183149381|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.889|1.166|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 VS Day 1 GSK962040 50 mg||1.166|0.889|
91628694|NCT01602549|183149381|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.865|||||TWO_SIDED|95.0|0.709|1.055|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 Vs Day 1 Placebo||1.055|0.709|
91628695|NCT01602549|183149382|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon rank-sum test|||Day 1||||0.157
91628696|NCT01602549|183149382|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon rank-sum test|||Day 8||||0.186
91628697|NCT01602549|183149384|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.239|||||TWO_SIDED|95.0|-16.015|7.537|||||Day 1: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||7.537|-16.015|
91525524|NCT01557322|182926227|SUPERIORITY_OR_OTHER|||||||0.5491|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test.||||0.5491
91628698|NCT01602549|183149384|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.327|||||TWO_SIDED|95.0|-17.567|6.914|||||Day 8: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||6.914|-17.567|
91628699|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.16||||||95.0|-3.9|-0.41|||||Day 1; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 1||-0.41|-3.90|
91628700|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.63|||||TWO_SIDED|95.0|-5.41|-1.85|||||Day 8; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 8||-1.85|-5.41|
91628701|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.29|||||TWO_SIDED|95.0|-4.65|0.07|||||Day 1; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 1||0.07|-4.65|
91628702|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.46|||||TWO_SIDED|95.0|-4.85|-0.07|||||Day 8; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 8||-0.07|-4.85|
91628703|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.38|||||TWO_SIDED|95.0|-10.28|-0.49|||||Day 8; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III -GSK962040 50 mg Vs Placebo Day 8||-0.49|-10.28|
91628704|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.56|||||TWO_SIDED|95.0|-1.65|0.54|||||Day 1; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 1||0.54|-1.65|
91628705|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.9|||||TWO_SIDED|95.0|-2.02|0.22|||||Day 8; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 8||0.22|-2.02|
91628706|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.69|||||TWO_SIDED|95.0|-13.77|0.39|||||Day 1; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 1||0.39|-13.77|
91628707|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-12.5|||||TWO_SIDED|95.0|-19.67|-5.29|||||Day 8; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 8||-5.29|-19.67|
91628708|NCT01602549|183149385|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.7|||||TWO_SIDED|95.0|-6.53|3.13|||||Day 1; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III- GSK962040 50 mg Vs Placebo Day 1||3.13|-6.53|
91691980|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9694||95.0|-0.03|0.03|||ANCOVA|||Total Score Cycle 9||0.03|-0.03|0.9694
91628709|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.14|||||TWO_SIDED|95.0|-9.07|2.78|||||Day 1; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 1||2.78|-9.07|
91691981|NCT00380874|183278453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8957||95.0|-0.02|0.02|||ANCOVA|||Total Score LOCF Endpoint||0.02|-0.02|0.8957
91628710|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.18|||||TWO_SIDED|95.0|-9.11|2.75|||||Day 1; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||2.75|-9.11|
91628711|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.66|||||TWO_SIDED|95.0|-9.59|2.27|||||Day 1; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1:||2.27|-9.59|
91628712|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.15|||||TWO_SIDED|95.0|-10.07|1.76|||||Day 1; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||1.76|-10.07|
91628713|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.8|||||TWO_SIDED|95.0|-12.79|-0.81|||||Day 8; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 8||-0.81|-12.79|
91628714|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.97|||||TWO_SIDED|95.0|-9.96|2.03|||||Day 8; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||2.03|-9.96|
91628715|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.29|||||TWO_SIDED|95.0|-11.29|0.71|||||Day 8; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||0.71|-11.29|
91664783|NCT00112437|183222880|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||||TWO_SIDED|95.0|-8.48|47.88||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||47.88|-8.48|
91664784|NCT00112437|183222881|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.28||||0.004|TWO_SIDED|95.0|-35.82|-0.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||-0.74|-35.82|0.004
91664785|NCT00112437|183222881|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.26||||0.344|TWO_SIDED|95.0|-19.9|17.39||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.39|-19.90|0.344
91628716|NCT01602549|183149386|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-8.9|||||TWO_SIDED|95.0|-14.88|-2.91|||||Day 8; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||-2.91|-14.88|
91628717|NCT01602549|183149387|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.31|||||TWO_SIDED|95.0|-3.71|-0.9|||||OFF: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|OFF: Treatment Period||-0.90|-3.71|
91628718|NCT01602549|183149387|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.88|||||TWO_SIDED|95.0|0.28|3.48|||||ON: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|ON: Treatment Period||3.48|0.28|
91628719|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.83|||||TWO_SIDED|95.0|-21.79|16.13|||||Day 1, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: Day GSK962040 50 mg Vs Placebo Day 1||16.13|-21.79|
91628720|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.58|||||TWO_SIDED|95.0|-18.39|19.56|||||Day 1, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 1||19.56|-18.39|
91482817|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8482|TWO_SIDED|95.0|-1.11|1.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.35|-1.11|0.8482
91482818|NCT01227564|182839157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.49|1.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.64|-0.49|0.2840
91482819|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.1767|TWO_SIDED|95.0|-4.9|0.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.92|-4.90|0.1767
91482820|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.0057|TWO_SIDED|95.0|-7.23|-1.29||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-1.29|-7.23|0.0057
91482821|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.13||||0.0176|TWO_SIDED|95.0|-5.69|-0.57||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-0.57|-5.69|0.0176
91525525|NCT01557322|182926228|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
91628721|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.84|||||TWO_SIDED|95.0|-17.18|20.86|||||Day 1, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Day 1, 30 min PD||20.86|-17.18|
91525526|NCT01557322|182926229|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline HAQ-DI score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
91628722|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.28|||||TWO_SIDED|95.0|-18.72|19.28|||||Day 1, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 1||19.28|-18.72|
91628723|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.38|||||TWO_SIDED|95.0|-22.35|15.58|||||Day 1, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 1||15.58|-22.35|
91628724|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.18|||||TWO_SIDED|95.0|-23.13|14.76|||||Day 1, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||14.76|-23.13|
91628725|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.39|||||TWO_SIDED|95.0|-25.36|12.58|||||Day 1, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1||12.58|-25.36|
91628726|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.77|||||TWO_SIDED|95.0|-18.2|19.75|||||Day 1, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||19.75|-18.20|
91628727|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.51|||||TWO_SIDED|95.0|-18.51|19.52|||||Day 8, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: GSK962040 50 mg Vs Placebo Day 8||19.52|-18.51|
91628728|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.32|||||TWO_SIDED|95.0|-15.7|22.33|||||Day 8, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 8||22.33|-15.70|
91628729|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.94|||||TWO_SIDED|95.0|-21.97|16.08|||||Day 8, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|30 min PD: GSK962040 50 mg Vs Placebo Day 8||16.08|-21.97|
91628730|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.12|||||TWO_SIDED|95.0|-22.13|15.88|||||Day 8, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 8||15.88|-22.13|
91628731|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.38|||||TWO_SIDED|95.0|-20.4|17.63|||||Day 8, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 8||17.63|-20.40|
91628732|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.71|||||TWO_SIDED|95.0|-19.7|18.28|||||Day 8, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||18.28|-19.70|
91628733|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.02|||||TWO_SIDED|95.0|-15.98|22.02|||||Day 8, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||22.02|-15.98|
91628734|NCT01602549|183149388|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|4.08|||||TWO_SIDED|95.0|-14.91|23.07|||||Day 8, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||23.07|-14.91|
91628735|NCT03627494|183149460|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.03|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.03|0.84|
91628736|NCT03627494|183149461|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.04|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.04|0.84|
91628737|NCT03627494|183149462|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.79|1.01|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.01|0.79|
91628738|NCT02177786|183149502|SUPERIORITY||Least Square Means Difference|0.38|STANDARD_ERROR_OF_MEAN|1.21||0.755|TWO_SIDED|95.0|-2.0|2.75||Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||2.75|-2.00|0.755
91628739|NCT02177786|183149502|SUPERIORITY||Least Square Means Difference|0.84|STANDARD_ERROR_OF_MEAN|1.22||0.492|TWO_SIDED|95.0|-1.55|3.23||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||3.23|-1.55|0.492
91628740|NCT02177786|183149502|SUPERIORITY||Least Square Means Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.23||0.481|TWO_SIDED|95.0|-3.29|1.56||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||1.56|-3.29|0.481
91628741|NCT02177786|183149503|SUPERIORITY||Difference in Percentages|-2.2||||0.798|TWO_SIDED|95.0|-16.1|11.7|||Cochran-Mantel-Haenszel|P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||11.7|-16.1|0.798
91628742|NCT02177786|183149503|SUPERIORITY||Difference in Percentages|-9.2||||0.175|TWO_SIDED|95.0|-22.3|4.0|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||4.0|-22.3|0.175
91628743|NCT02177786|183149503|SUPERIORITY||Difference in Percentages|-2.9||||0.686|TWO_SIDED|95.0|-16.6|10.9|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||10.9|-16.6|0.686
91628744|NCT01957215|183149518|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.72||||0.0201||95.0|0.1134|1.3199||P- value was obtained from ANCOVA model with treatment and site as fixed effects and NRS Baseline value as a covariate|ANCOVA||ADJ DIFF is the Treatment difference defined as the Adjusted Mean of 0.35% Indomethacin Patches minus Adjusted Mean of Placebo Patches|||1.3199|0.1134|0.0201
91628745|NCT05724069|183149558|SUPERIORITY||Median Difference (Net)|-0.239|||=|0.1279|TWO_SIDED|95.0|-0.553|0.074|||paired T-test|||Subjects in this analysis are 15 and not 30 (this happens because arms are not mutually exclusive, as explained in previous sections). Each subject can contribute with 0, 1, 2 pairs. Only data that constitute pairs evaluable for primary endpoint are considered in the analysis; the pairs evaluable for primary endpoint were 23.||0.074|-0.553|=0.1279
91628746|NCT03552289|183149559|SUPERIORITY|||||||0.8283|||||||One-sided Z-test|||||||0.8283
91628747|NCT02408484|183149622|OTHER|||||||0.0028||||||p-value for the change in MCF from baseline to 1 hour post infusion for the firstBLEED population|ANOVA|||||||0.0028
91628748|NCT02408484|183149622|OTHER|||||||0.0002||||||p-value for the change in MCF from baseline to 1 hour post infusion for the BLEED population|ANOVA|||||||0.0002
91628749|NCT01726504|183149632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P\<0.001) times more than that in the SA group.||||<0.001
91628750|NCT00524043|183149664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|4.2||0.504||95.0|-5.47|11.09||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Sample size estimation was based on the assumption that the difference between the paliperidone ER 1.5 mg dose group and the placebo group in the mean change in PANSS total score from baseline to end point was 11 points with a within-group standard deviation of 20 points. It was calculated that 65 patients were needed per treatment group to detect a statistically significant treatment difference between the paliperidone ER 1.5 mg dose group and the placebo group with a power of 87.5%.||11.09|-5.47|0.504
91628751|NCT00524043|183149664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.431||95.0|-11.46|4.9||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|Paliperidone ER 6 mg was used for assay sensitivity||||4.90|-11.46|0.431
91628752|NCT00524043|183149665|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||Based on ANCOVA model on ranks with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.626
91628753|NCT00524043|183149666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.69||0.87||95.0|-4.86|5.74||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||5.74|-4.86|0.870
91628754|NCT00524043|183149667|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.126
91628755|NCT00524043|183149668|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.691
91628756|NCT03012594|183149669|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.07
91628757|NCT03531762|183149700|OTHER||Ratio of Geometric Least Square Mean|108.87|||||TWO_SIDED|90.0|101.2|117.13||||||||117.13|101.20|
91628758|NCT03531762|183149701|OTHER||Ratio of Geometric Least Square Mean|109.8|||||TWO_SIDED|90.0|101.69|118.55||||||||118.55|101.69|
91628759|NCT03531762|183149702|OTHER||Ratio of Geometric Least Square Mean|104.1|||||TWO_SIDED|90.0|92.93|116.61||||||||116.61|92.93|
91628760|NCT02019758|183149714|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.||||0.31
91628761|NCT02019758|183149715|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.||||0.70
91628762|NCT02019758|183149720|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.52|2.08||||||||2.08|0.52|
91628763|NCT02019758|183149721|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91628764|NCT02019758|183149722|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91628765|NCT02019758|183149723|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91628766|NCT00735072|183149728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.||||0.014
91628767|NCT00735072|183149729|OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
91628768|NCT00735072|183149730|OTHER|||||||0.33|||||||Mixed Models Analysis|||||||0.33
91628769|NCT01291511|183149743|SUPERIORITY||Cox Proportional Hazard|5.2|||<|0.0001|TWO_SIDED|95.0|3.2|8.4|||Log Rank|||||8.4|3.2|<0.0001
91628770|NCT01291511|183149744|SUPERIORITY||||||<|0.0001||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||<0.0001
91628771|NCT01291511|183149746|SUPERIORITY|||||||0.0062||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||0.0062
91628772|NCT01263314|183149758|OTHER||Mean Difference (Final Values)|-1.25||||0.3551|TWO_SIDED|90.0|-7.01|4.5|||ANOVA|||||4.50|-7.01|0.3551
91628773|NCT01263314|183149758|OTHER||Mean Difference (Final Values)|-1.32||||0.3474|TWO_SIDED|90.0|-7.08|4.48|||ANOVA|||||4.48|-7.08|0.3474
91628774|NCT01263314|183149758|OTHER||Mean Difference (Final Values)|-1.67||||0.3105|TWO_SIDED|90.0|-7.42|4.09|||ANOVA|||||4.09|-7.42|0.3105
91628775|NCT01263314|183149758|OTHER||Mean Difference (Final Values)|-6.25||||0.1346|TWO_SIDED|90.0|-15.8|3.27|||ANOVA|||||3.27|-15.8|0.1346
91628776|NCT01263314|183149758|OTHER||Mean Difference (Final Values)|-10.1||||0.0416|TWO_SIDED|90.0|-19.6|-0.56|||ANOVA|||||-0.56|-19.6|0.0416
91628777|NCT01263314|183149758|OTHER||Mean Difference (Final Values)|-8.2||||0.0762|TWO_SIDED|90.0|-17.7|1.32|||ANOVA|||||1.32|-17.7|0.0762
91628778|NCT01263314|183149759|OTHER||Mean Difference (Final Values)|0.47||||0.418|TWO_SIDED|90.0|-3.47|4.41|||ANOVA|||||4.41|-3.47|0.418
91628779|NCT01263314|183149759|OTHER||Mean Difference (Final Values)|4.12||||0.0434|TWO_SIDED|90.0|0.18|8.05|||ANOVA|||||8.05|0.18|0.0434
91628780|NCT01263314|183149759|OTHER||Mean Difference (Final Values)|7.79||||0.0019|TWO_SIDED|90.0|3.85|11.72|||ANOVA|||||11.72|3.85|0.0019
91628781|NCT01263314|183149759|OTHER||Mean Difference (Final Values)|1.15||||0.2223|TWO_SIDED|90.0|-1.42|3.71|||ANOVA|||||3.71|-1.42|0.2223
91628782|NCT01263314|183149759|OTHER||Mean Difference (Final Values)|4.25||||0.0056|TWO_SIDED|90.0|1.69|6.82|||ANOVA|||||6.82|1.69|0.0056
91628783|NCT01263314|183149759|OTHER||Mean Difference (Final Values)|5.4||||0.0012|TWO_SIDED|90.0|2.83|7.96|||ANOVA|||||7.96|2.83|0.0012
91628784|NCT01263314|183149761|OTHER||GMR (Elderly female/Elderly male)|1.23|||||TWO_SIDED|90.0|0.85|1.76|||||GMR = geometric mean ratio|||1.76|0.85|
91628785|NCT01263314|183149762|OTHER||GMR (Elderly female/Elderly male)|1.08|||||TWO_SIDED|90.0|0.88|1.33||||||||1.33|0.88|
91628786|NCT01263314|183149762|OTHER||GMR (Elderly female/Elderly male)|1.26|||||TWO_SIDED|90.0|1.02|1.55||||||||1.55|1.02|
91628787|NCT01263314|183149762|OTHER||GMR (Elderly female/Elderly male)|1.2|||||TWO_SIDED|90.0|0.98|1.48||||||||1.48|0.98|
91628788|NCT01263314|183149765|SUPERIORITY||MK-8266 0.3 mg vs. placebo|9.58||||0.0253|TWO_SIDED|90.0|1.69|17.46|||ANOVA|||||17.46|1.69|0.0253
91714174|NCT03843372|183320164|SUPERIORITY|||||||0.008|||||||Wilcoxon rank sum test|||The sleep efficiency was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare sleep efficiency between CPAP and HFNC||||0.008
91482822|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.679|TWO_SIDED|95.0|-3.98|2.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.61|-3.98|0.6790
91525527|NCT01557322|182926230|SUPERIORITY_OR_OTHER|||||||0.2558|TWO_SIDED||||||Regression, Linear|||PCS: p-value was calculated using multivariate linear regression with baseline PCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.2558
91628789|NCT01263314|183149765|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-2.59||||0.2856|TWO_SIDED|90.0|-10.5|5.29|||ANOVA|||||5.29|-10.5|0.2856
91628790|NCT01263314|183149765|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-4.06||||0.1895|TWO_SIDED|90.0|-11.9|3.82|||ANOVA|||||3.82|-11.9|0.1895
91628791|NCT01263314|183149765|SUPERIORITY||MK-8266 0.3 mg vs. placebo|-4.16||||0.1157|TWO_SIDED|90.0|-10.0|1.7|||ANOVA|||||1.70|-10.0|0.1157
91628792|NCT01263314|183149765|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-11.7||||0.0018|TWO_SIDED|90.0|-17.5|-5.79|||ANOVA|||||-5.79|-17.5|0.0018
91628793|NCT01263314|183149765|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-10.6||||0.0034|TWO_SIDED|90.0|-16.5|-4.77|||ANOVA|||||-4.77|-16.5|0.0034
91628794|NCT00654420|183149807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.268|TWO_SIDED|95.0|0.47|1.57|||Finkelstein Proportional Hazards Model|||Finkelstein proportional hazards model for interval-censored data was used to assess treatment effect on PFS in Phase II. The hazard ratio with 95% confidence interval for the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported.||1.57|0.47|0.268
91628795|NCT00654420|183149808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.879|TWO_SIDED|95.0|0.78|2.64|||Regression, Cox|||The treatment difference in survival between treatment groups was assessed by Cox regression. The estimated hazard ratio for treatment of the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported from the Cox model.||2.64|0.78|0.879
91628796|NCT00654420|183149809|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8||||0.721|TWO_SIDED|95.0|-15.9|9.4|||Miettinen & Nurminen Method|||Miettinen and Nurminen's method for stratified data was used for comparison of percentage of participants with objective response (ORR) between the two treatment groups. Response rate calculation was based on full follow-up.||9.4|-15.9|0.721
91628797|NCT03236506|183149826|NON_INFERIORITY|Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group.|Odds Ratio (OR)|0.64||||0.67|TWO_SIDED|95.0|0.14|3.0|||Logistic|||||3.00|0.14|0.67
91628798|NCT03236506|183149826|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|0.53||||0.41|TWO_SIDED|95.0|0.11|2.45|||logistic|||||2.45|0.11|0.41
91628799|NCT03236506|183149826|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|1.22||||0.82|TWO_SIDED|95.0|0.23|6.61|||logistic|||||6.61|0.23|0.82
91628800|NCT00638274|183149836|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
91628801|NCT00638274|183149836|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
91628802|NCT00838383|183149848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-70.0||||0.5307|TWO_SIDED|95.0|-291.3|151.4|||ANCOVA|||||151.4|-291.3|0.5307
91628803|NCT00838383|183149848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-73.2||||0.5121|TWO_SIDED|95.0|-294.5|148.2|||ANCOVA|||||148.2|-294.5|0.5121
91628804|NCT00838383|183149849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-123.1||||0.2735|TWO_SIDED|95.0|-345.5|99.3|||ANCOVA|||||99.3|-345.5|0.2735
91628805|NCT00838383|183149849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-174.5||||0.1223|TWO_SIDED|95.0|-396.8|47.9|||ANCOVA|||||47.9|-396.8|0.1223
91628806|NCT00838383|183149850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-66.6||||0.5505|TWO_SIDED|95.0|-288.0|154.8|||ANCOVA|||||154.8|-288.0|0.5505
91628807|NCT00838383|183149850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-110.3||||0.3237|TWO_SIDED|95.0|-331.7|111.0|||ANCOVA|||||111.0|-331.7|0.3237
91628808|NCT00838383|183149851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-166.5||||0.1412|TWO_SIDED|95.0|-389.6|56.6|||ANCOVA|||||56.6|-389.6|0.1412
91628809|NCT00838383|183149851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-199.8||||0.0813|TWO_SIDED|95.0|-425.0|25.5|||ANCOVA|||||25.5|-425.0|0.0813
91628810|NCT02709109|183149877|SUPERIORITY||Least Square (LS) mean difference|0.2||||0.8173|TWO_SIDED|95.0|-1.4|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-1.4|0.8173
91525528|NCT01557322|182926230|SUPERIORITY_OR_OTHER|||||||0.4908|TWO_SIDED||||||Regression, Linear|||MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.4908
91525529|NCT01557322|182926230|SUPERIORITY_OR_OTHER|||||||0.8379|TWO_SIDED||||||Regression, Linear|||Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.8379
91628811|NCT02709109|183149877|SUPERIORITY||LS mean difference|-0.7||||0.5903|TWO_SIDED|95.0|-3.3|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.3|0.5903
91628812|NCT02709109|183149877|SUPERIORITY||LS mean difference|-0.7||||0.5917|TWO_SIDED|95.0|-3.4|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.4|0.5917
91628813|NCT02709109|183149877|SUPERIORITY||LS mean difference|-0.9||||0.5021|TWO_SIDED|95.0|-3.6|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-3.6|0.5021
91628814|NCT02709109|183149877|SUPERIORITY||LS mean difference|-1.6||||0.1382|TWO_SIDED|95.0|-3.8|0.5|||Mixed-effects Model for Repeated Measure|||||0.5|-3.8|0.1382
91628815|NCT02709109|183149877|SUPERIORITY||LS mean difference|0.9||||0.4962|TWO_SIDED|95.0|-1.7|3.5|||Mixed-effects Model for Repeated Measure|||||3.5|-1.7|0.4962
91628816|NCT01000818|183149880|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.39||||||95.0|1.04|1.84||||||||1.84|1.04|
91628817|NCT01000818|183149880|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.45||||||95.0|1.09|1.93||||||||1.93|1.09|
91628818|NCT03920865|183149911|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.802|||||TWO_SIDED|90.0|0.627|1.03||||||||1.03|0.627|
91628819|NCT03920865|183149911|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.842|||||TWO_SIDED|90.0|0.588|1.21||||||||1.21|0.588|
91628820|NCT03920865|183149913|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.95|||||TWO_SIDED|90.0|0.695|1.3||||||||1.30|0.695|
91628821|NCT03920865|183149913|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.953|||||TWO_SIDED|90.0|0.715|1.27||||||||1.27|0.715|
91628822|NCT03920865|183149914|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.83|1.39||||||||1.39|0.830|
91628823|NCT03920865|183149914|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.947|||||TWO_SIDED|90.0|0.74|1.21||||||||1.21|0.740|
91628824|NCT03920865|183149916|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|0.962|1.49||||||||1.49|0.962|
91628825|NCT03920865|183149916|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.991|||||TWO_SIDED|90.0|0.81|1.21||||||||1.21|0.810|
91628826|NCT04010370|183149935|SUPERIORITY||||||<|0.001|||||||Spearman correlation|||Correlation of McAuley index with PREDIM index at baseline.||||<0.001
91628827|NCT04010370|183149936|SUPERIORITY|||||||0.319|||||||Spearman correlation|||Correlation of Belfiore index with PREDIM index at baseline.||||0.319
91628828|NCT04010370|183149937|SUPERIORITY|||||||0.27|||||||Spearman correlation|||Correlation of Cederholm index with PREDIM index at baseline.||||0.27
91628829|NCT04010370|183149938|SUPERIORITY|||||||0.246|||||||Spearman correlation|||Correlation of Avignon index with PREDIM index at baseline.||||0.246
91628830|NCT04010370|183149939|SUPERIORITY|||||||0.259|||||||Spearman correlation|||Correlation of Matsuda index with PREDIM index at baseline.||||0.259
91628831|NCT04010370|183149940|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of Gutt index with PREDIM index at baseline.||||0.69
91628832|NCT04010370|183149941|SUPERIORITY|||||||0.022|||||||Spearman correlation|||Correlation of Stumvoll index with PREDIM index at baseline.||||0.022
91628833|NCT04010370|183149942|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of HOMA-IR index with PREDIM index at baseline.||||0.69
91628834|NCT04010370|183149943|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of ISI index with PREDIM index at baseline.||||0.69
91628835|NCT04010370|183149944|SUPERIORITY|||||||0.541|||||||Spearman correlation|||Correlation of Raynaud index with PREDIM index at baseline.||||0.541
91628836|NCT04010370|183149945|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of QUICKI index with PREDIM index at baseline.||||0.69
91628837|NCT04010370|183149946|SUPERIORITY|||||||0.531|||||||Spearman correlation|||Correlation of FIRI index with PREDIM index at baseline.||||0.531
91628838|NCT04010370|183149947|SUPERIORITY|||||||0.726|||||||Spearman correlation|||Correlation of Bennett index with PREDIM index at baseline.||||0.726
91628839|NCT04010370|183149948|SUPERIORITY|||||||0.787|||||||Spearman correlation|||Correlation of TyG index with PREDIM index at baseline.||||0.787
91628840|NCT01815580|183149960|OTHER||||||>|0.75|||||||Chi-squared|||||||>0.75
91628841|NCT01815580|183149961|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
91628842|NCT01815580|183149962|OTHER||||||>|0.3|||||||Chi-squared|||||||>0.3
91628843|NCT01815580|183149963|OTHER||||||>|0.12|||||||Chi-squared|||||||>0.12
91628844|NCT01815580|183149964|OTHER||||||>|0.22|||||||Chi-squared|||||||>0.22
91692405|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-1.7|5.3||||||3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||5.3|-1.7|
91628845|NCT01610206|183149970|EQUIVALENCE|To estimate the progression-free survival hazard ratio of the combination of weekly gemcitabine and pazopanib compared to weekly gemcitabine alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.|Hazard Ratio (HR)|0.81||||0.019|TWO_SIDED|95.0|0.61|1.07|||non-parametric weighted Tarone-Ware test|||||1.07|0.61|0.019
91628846|NCT02859558|183149993|SUPERIORITY|||||||0.48||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.48
91628847|NCT02859558|183149993|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
91482823|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.9028|TWO_SIDED|95.0|-3.62|3.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||3.20|-3.62|0.9028
91628848|NCT02859558|183149993|SUPERIORITY|||||||0.5||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.50
91664786|NCT00112437|183222881|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.33|||||TWO_SIDED|95.0|-20.55|17.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.89|-20.55|
91628849|NCT02859558|183149993|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
91525530|NCT01552954|182926290|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||for albuminuria changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||Differences with two-tailed P\<0.05 were considered statistically significant.||||0.006
91628850|NCT02859558|183149993|SUPERIORITY|||||||0.44||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.44
91628851|NCT02859558|183149993|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
91628852|NCT02859558|183149994|SUPERIORITY|||||||0.39||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.39
91628853|NCT02859558|183149994|SUPERIORITY|||||||0.46||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.46
91628854|NCT02859558|183149994|SUPERIORITY|||||||0.056||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.056
91628855|NCT02859558|183149994|SUPERIORITY|||||||0.025||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.025
91628856|NCT02859558|183149994|SUPERIORITY|||||||0.072||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.072
91628857|NCT02859558|183149994|SUPERIORITY|||||||0.47||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.47
91628858|NCT02859558|183149994|SUPERIORITY|||||||0.086||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.086
91628859|NCT02859558|183149994|SUPERIORITY|||||||0.18||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.18
91628860|NCT02859558|183149994|SUPERIORITY|||||||0.88||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.88
91628861|NCT02859558|183149994|SUPERIORITY|||||||0.061||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.061
91525531|NCT01552954|182926290|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks|Mixed Models Analysis|||||||0.99
91525532|NCT01552954|182926290|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group|Mixed Models Analysis|||||||0.001
91664787|NCT00112437|183222881|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|28.15|||||TWO_SIDED|95.0|5.84|50.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||50.46|5.84|
91664788|NCT00112437|183222882|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-15.57|||<=|0.001|TWO_SIDED|95.0|-26.11|-5.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||-5.04|-26.11|<=0.001
91664789|NCT00112437|183222882|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.43||||0.645|TWO_SIDED|95.0|-6.02|16.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||16.89|-6.02|0.645
91664790|NCT00112437|183222882|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|11.73|||||TWO_SIDED|95.0|-0.47|23.92||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||23.92|-0.47|
91664791|NCT00112437|183222882|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|44.85|||||TWO_SIDED|95.0|30.55|59.16||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||59.16|30.55|
91664792|NCT00112437|183222883|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-35.74|||<=|0.001|TWO_SIDED|95.0|-52.14|-19.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||-19.33|-52.14|<=0.001
91664793|NCT00112437|183222883|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.68||||0.161|TWO_SIDED|95.0|-20.58|17.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.23|-20.58|0.161
91722496|NCT04225832|183337787|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED|||||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Linear|Regression results control for immigration status, length of time in U.S., and baseline value of the outcome|Slope is adjusted regression coefficient for indicator of intervention arm|"Unlike the observed at any FU primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant."||||.14
91525533|NCT01552954|182926291|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|||||for hemoglobin changes from week 0 at week 16 (week 0 - week 16)|t-test, 2 sided|||||||0.187
91525534|NCT01552954|182926292|SUPERIORITY_OR_OTHER|||||||0.001||||||for changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.001
91525535|NCT01552954|182926293|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||for sBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||>0.05
91525536|NCT01552954|182926293|SUPERIORITY_OR_OTHER|||||||0.585|TWO_SIDED|||||for dBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.585
91525537|NCT01395823|182926298|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
91628862|NCT02859558|183149994|SUPERIORITY|||||||0.042||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.042
91628863|NCT02859558|183149994|SUPERIORITY|||||||0.54||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.54
91628864|NCT02859558|183149995|SUPERIORITY|||||||0.97||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.97
91628865|NCT02859558|183149995|SUPERIORITY|||||||0.21||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.21
91628866|NCT02859558|183149995|SUPERIORITY|||||||0.12||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.12
91628867|NCT02859558|183149995|SUPERIORITY|||||||0.055||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.055
91628868|NCT02859558|183149995|SUPERIORITY|||||||0.28||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.28
91628869|NCT02859558|183149995|SUPERIORITY|||||||0.38||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.38
91628870|NCT02859558|183149995|SUPERIORITY|||||||0.35||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.35
91628871|NCT02859558|183149995|SUPERIORITY|||||||0.007||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.007
91628872|NCT02859558|183149995|SUPERIORITY|||||||0.045||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.045
91628873|NCT02859558|183149995|SUPERIORITY|||||||0.085||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.085
91628874|NCT02859558|183149995|SUPERIORITY|||||||0.044||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.044
91628875|NCT02859558|183149995|SUPERIORITY|||||||0.6||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.60
91628876|NCT02859558|183149996|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
91628877|NCT02859558|183149996|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
91628878|NCT02859558|183149996|SUPERIORITY|||||||0.64||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.64
91628879|NCT02859558|183149996|SUPERIORITY|||||||0.69||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.69
91628880|NCT02859558|183149996|SUPERIORITY|||||||0.4||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.40
91628881|NCT02859558|183149996|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
91714175|NCT00243919|183320169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.831||||0.481|TWO_SIDED|95.0|0.497|1.391||The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.|Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.||1.391|0.497|0.481
91482824|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45||||0.76|TWO_SIDED|95.0|-3.36|2.47||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.47|-3.36|0.7600
91525538|NCT00116272|182926299|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77|||||TWO_SIDED|95.0|1.04|7.35|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||7.35|1.04|
91628882|NCT02859558|183149996|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
91628883|NCT04507360|183150002|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||"Mean difference in Overall row"||||
91628884|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
91628885|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|0.63|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
91628886|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
91628887|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|0.62|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
91628888|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|0.85|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
91628889|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
91628890|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
91628891|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|2.16|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
91628892|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|2.69|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
91628893|NCT04507360|183150004|SUPERIORITY||Mean Difference (Final Values)|1.75|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
91628894|NCT04507360|183150005|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
91628895|NCT04507360|183150005|SUPERIORITY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
91628896|NCT04507360|183150005|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
91628897|NCT04507360|183150005|SUPERIORITY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
91628898|NCT04507360|183150006|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
91628899|NCT04507360|183150006|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
91628900|NCT04507360|183150006|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
91628901|NCT04507360|183150006|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
91628902|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
91628903|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
91628904|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|1.24|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
91628905|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
91628906|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
91628907|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|1.98|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
91628908|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|1.18|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
91628909|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|3.67|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
91628910|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
91628911|NCT04507360|183150007|SUPERIORITY||Mean Difference (Final Values)|2.07|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
91628912|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|||||||||Mean difference at baseline||||
91628913|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference at week 1||||
91628914|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|||||||||Mean difference at week 2||||
91628915|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|||||||||Mean difference at week 3||||
91628916|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|1.68|||||TWO_SIDED|||||||||Mean difference at week 4||||
91628917|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|||||||||Mean difference at week 8||||
91792087|NCT03036800|183461943|SUPERIORITY||Odds Ratio (OR)|4.11||||0.07|TWO_SIDED|95.0|0.89|18.93|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||18.93|0.89|0.070
91628918|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.28|||||TWO_SIDED|||||||||Mean difference at baseline||||
91628919|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.67|||||TWO_SIDED|||||||||Mean difference at week 1||||
91628920|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.78|||||TWO_SIDED|||||||||Mean difference at week 2||||
91628921|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at week 3||||
91628922|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference at week 4||||
91628923|NCT04507360|183150010|SUPERIORITY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|||||||||Mean difference at week 8||||
91628924|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at baseline||||
91792088|NCT03036800|183461944|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
91628925|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|||||||||Mean difference at week 1||||
91628926|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||Mean difference at week 2||||
91628927|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|||||||||Mean difference at week 3||||
91628928|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|||||||||Mean difference at week 4||||
91628929|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 8||||
91628930|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|||||||||Mean difference at baseline||||
91628931|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 1||||
91628932|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|||||||||Mean difference at week 2||||
91628933|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 3||||
91628934|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 4||||
91628935|NCT04507360|183150011|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference at week 8||||
91628936|NCT00400946|183150012|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||.60
91628937|NCT03950440|183150027|OTHER|Propensity scores were obtained from three separate multivariable logistic regression models contrasting each group versus the two other groups. The result from this multivariable model quantifies the degree of separation between both groups.|Risk Ratio (RR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.44||The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|Poisson regression||TAVI-group compared to the SAVR-group|Frailty scores (Tilburg and essential) and Euroscore were specified in the protocol. Age was added during the meeting before start of the data-analysis|The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|0.44|0.16|<0.0001
91628938|NCT00439309|183150046|NON_INFERIORITY_OR_EQUIVALENCE|The sealing success rates for the investigational group and control groups were assumed to be 0.85 (85%) and 0.75 (75%), respectively, and the non-inferiority margin (10%) is 0.10. For safety reasons it was desired to have at least 100 Vascular Sealant treated subjects. It was determined that a sample size of at least 31 evaluable subjects is required for the control group. For blocking purposes, the number of evaluable control group subjects was set to 33, for a 3:1 randomization.||||||0.072|||||||Z-Test|one-sided Z-test based on the normal approximation to the binomial distribution testing||The effectiveness analyses were performed on the ITT population.||||0.072
91628939|NCT00439309|183150047|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAM Treatment from two-sided test based on the GEE regression model.||||||0.006
91628940|NCT00439309|183150048|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAMTreatment from two-sided test based on the GEE regression model||||||0.654
91628941|NCT00439309|183150049|SUPERIORITY_OR_OTHER|||||||0.089|||||||t-test, 2 sided|||||||0.089
91628942|NCT00439309|183150050|SUPERIORITY_OR_OTHER|||||||0.404|||||||Log Rank|Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group||||||0.404
91628943|NCT02043509|183150051|SUPERIORITY||Adjusted odds ratio|2.7|||||TWO_SIDED|95.0|0.93|9.35|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||9.35|0.93|
91628944|NCT02043509|183150052|SUPERIORITY||Adjusted odds ratio|1.03|||||TWO_SIDED|95.0|0.61|1.75|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||1.75|0.61|
91628945|NCT02043509|183150053|SUPERIORITY||Adjusted odds ratio|1.34|||||TWO_SIDED|95.0|0.79|2.31|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||2.31|0.79|
91628946|NCT02043509|183150054|SUPERIORITY||Adjusted odds ratio|1.67|||||TWO_SIDED|95.0|0.72|4.03|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||4.03|0.72|
91628947|NCT02043509|183150055|SUPERIORITY||Adjusted odds ratio|2.11|||||TWO_SIDED|95.0|0.89|5.46|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||5.46|0.89|
91792089|NCT03036800|183461945|SUPERIORITY||Mean Difference (Net)|-4.63|||<|0.001|TWO_SIDED|95.0|-5.85|-3.4|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.4|-5.85|<0.001
91482825|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4089|TWO_SIDED|95.0|-4.51|1.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.86|-4.51|0.4089
91628948|NCT02043509|183150056|SUPERIORITY||Adjusted odds ratio|3.16|||||TWO_SIDED|95.0|1.14|10.69|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||10.69|1.14|
91628949|NCT02043509|183150057|SUPERIORITY||Adjusted odds ratio|3.28|||||TWO_SIDED|95.0|0.9|17.36|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||17.36|0.90|
91628950|NCT02043509|183150058|SUPERIORITY|||||||0.118|||||||Mann-Whitney U-test|||||||0.118
91628951|NCT03189563|183150062|SUPERIORITY|||||||0.3656||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3656
91628952|NCT03189563|183150062|SUPERIORITY|||||||0.3119||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3119
91628953|NCT03189563|183150063|SUPERIORITY|||||||0.147||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1470
91628954|NCT03189563|183150063|SUPERIORITY|||||||0.252||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2520
91628955|NCT03189563|183150064|SUPERIORITY|||||||0.1528||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1528
91628956|NCT03189563|183150064|SUPERIORITY|||||||0.6146||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6146
91628957|NCT03189563|183150065|SUPERIORITY|||||||0.5691||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5691
91628958|NCT03189563|183150065|SUPERIORITY|||||||0.1309||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1309
91628959|NCT03189563|183150066|SUPERIORITY|||||||0.7913||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.7913
91628960|NCT03189563|183150066|SUPERIORITY|||||||0.9399||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.9399
91628961|NCT03189563|183150067|SUPERIORITY|||||||0.4978||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.4978
91628962|NCT03189563|183150067|SUPERIORITY|||||||0.888||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8880
91628963|NCT03189563|183150068|SUPERIORITY|||||||0.5755||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5755
91628964|NCT03189563|183150068|SUPERIORITY|||||||0.1517||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1517
91628965|NCT03189563|183150069|SUPERIORITY|||||||0.2095||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2095
91628966|NCT03189563|183150069|SUPERIORITY|||||||0.6094||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6094
91628967|NCT03189563|183150070|SUPERIORITY|||||||0.226||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
91628968|NCT03189563|183150070|SUPERIORITY|||||||0.226||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
91628969|NCT03189563|183150071|SUPERIORITY|||||||0.8274||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8274
91628970|NCT03189563|183150071|SUPERIORITY|||||||0.3416||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3416
91628971|NCT03189563|183150072|SUPERIORITY|||||||0.4052||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.4052
91628972|NCT03189563|183150072|SUPERIORITY|||||||0.2643||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.2643
91714176|NCT00243919|183320169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.501|TWO_SIDED|95.0|0.715|1.985|||Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||1.985|0.715|0.501
91714177|NCT00243919|183320170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.242||95.0||||We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.|Regression, Linear||Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.|The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.||||0.242
91714178|NCT00243919|183320171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.01|TWO_SIDED|95.0|1.18|3.21|||Regression, Logistic|Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.21|1.18|0.010
91714179|NCT00243919|183320171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.007|TWO_SIDED|95.0|1.22|3.42|||Regression, Logistic|Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.42|1.22|0.007
91714180|NCT00243919|183320172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.16||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.||0.16|0.08|<0.0001
91714181|NCT00243919|183320172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.05|0.14||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.||0.14|0.05|<.0001
91714182|NCT00243919|183320173|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.|ANOVA|||Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.45
91714183|NCT00243919|183320173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
91482826|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.1964|TWO_SIDED|95.0|-5.49|1.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.15|-5.49|0.1964
91525539|NCT00116272|182926300|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37|||||TWO_SIDED|95.0|1.02|5.52|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||5.52|1.02|
91714184|NCT00243919|183320174|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.||12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.10
91714185|NCT00243919|183320174|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.||6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.04
91714186|NCT00243919|183320175|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.48
91714187|NCT00243919|183320175|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
91714188|NCT00243919|183320176|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.07
91525540|NCT00116272|182926301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.01|||||Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.|||2.01|0.70|
91664794|NCT00112437|183222883|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.58|||||TWO_SIDED|95.0|-20.99|17.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.82|-20.99|
91664795|NCT00112437|183222883|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|46.9|||||TWO_SIDED|95.0|22.35|71.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||71.44|22.35|
91664796|NCT00112437|183222884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.1|||<=|0.001|TWO_SIDED|95.0|2.77|5.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||5.42|2.77|<=0.001
91664797|NCT00112437|183222884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.48|||<=|0.001|TWO_SIDED|95.0|2.2|4.77||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.77|2.20|<=0.001
91664798|NCT00112437|183222884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.75|||<=|0.001|TWO_SIDED|95.0|1.43|4.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.07|1.43|<=0.001
91664799|NCT00112437|183222884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.51||||0.536|TWO_SIDED|95.0|-1.84|0.83||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||0.83|-1.84|0.536
91714189|NCT00243919|183320176|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.03
91714190|NCT00243919|183320177|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.69
91792090|NCT03036800|183461946|SUPERIORITY||Mean Difference (Net)|-5.89|||<|0.001|TWO_SIDED|95.0|-7.76|-4.02|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.02|-7.76|<0.001
91792091|NCT03036800|183461947|SUPERIORITY||Mean Difference (Net)|-6.87|||<|0.001|TWO_SIDED|95.0|-9.03|-4.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.71|-9.03|<0.001
91792092|NCT03036800|183461948|SUPERIORITY||Mean Difference (Net)|-5.44|||<|0.001|TWO_SIDED|95.0|-8.34|-2.53|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.53|-8.34|<0.001
91525541|NCT00116272|182926303|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.2|1.12|||||Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.|||1.12|0.20|
91792093|NCT03036800|183461949|SUPERIORITY||Mean Difference (Net)|-3.72|||<|0.001|TWO_SIDED|95.0|-4.63|-2.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.80|-4.63|<0.001
91525542|NCT00116272|182926304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.86|2.98|||||Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia|||2.98|0.86|
91525543|NCT00116272|182926305|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.2|||||TWO_SIDED|95.0|-0.65|0.26|||||Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.|||0.26|-0.65|
91628973|NCT02443155|183150135|SUPERIORITY||Treatment ratio|1.48|||=|0.0017|TWO_SIDED|95.0|1.16|1.89|||Mixed model repeated measurements||NNC0114-0006 + liraglutide / Placebo|Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.89|1.16|=0.0017
91628974|NCT02443155|183150135|SUPERIORITY||Treatment Ratio|1.23|||=|0.0927|TWO_SIDED|95.0|0.97|1.57|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.57|0.97|=0.0927
91628975|NCT02443155|183150135|SUPERIORITY||Treatment Ratio|1.12|||=|0.378|TWO_SIDED|95.0|0.87|1.42|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.42|0.87|=0.3780
91628976|NCT02443155|183150135|SUPERIORITY||Treatment ratio|1.2|||=|0.1377|TWO_SIDED|95.0|0.94|1.53|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.53|0.94|=0.1377
91628977|NCT02443155|183150135|SUPERIORITY||Treatment ratio|1.33|||=|0.0214|TWO_SIDED|95.0|1.04|1.69|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.69|1.04|=0.0214
91628978|NCT02443155|183150135|SUPERIORITY||Treatmrnt ratio|1.1|||=|0.4187|TWO_SIDED|95.0|0.87|1.41|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.41|0.87|=0.4187
91628979|NCT01998906|183150276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.0051|TWO_SIDED|95.0|5.0|30.2|||Chi-squared|||||30.2|5.0|0.0051
91628980|NCT01998906|183150277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3||||0.0014|TWO_SIDED|95.0|7.2|31.4|||Chi-squared|||||31.4|7.2|0.0014
91628981|NCT01998906|183150278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3077|TWO_SIDED|95.0|-6.4|19.1|||Chi-squared|||||19.1|-6.4|0.3077
91628982|NCT01998906|183150280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0275|TWO_SIDED|95.0|0.44|0.96|||Log Rank|||||0.96|0.44|0.0275
91628983|NCT01998906|183150282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0555|TWO_SIDED|95.0|0.35|1.02|||Log Rank|||||1.02|0.35|0.0555
91628984|NCT05241470|183150303|SUPERIORITY||Mean Difference (Net)|0.01||||0.9575|TWO_SIDED||||||ANCOVA|||||||0.9575
91628985|NCT05241470|183150303|SUPERIORITY||Mean Difference (Net)|0.01||||0.9741|TWO_SIDED||||||ANCOVA|||||||0.9741
91628986|NCT05241470|183150304|SUPERIORITY|||||||0.5696|||||||ANCOVA|||||||0.5696
91628987|NCT05241470|183150305|SUPERIORITY|||||||0.0266|||||||Fisher Exact|||||||0.0266
91628988|NCT05241470|183150306|SUPERIORITY|||||||0.0055|||||||ANCOVA|||||||0.0055
91628989|NCT05241470|183150307|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
91628990|NCT05241470|183150308|SUPERIORITY|||||||0.0137|||||||ANCOVA|||||||0.0137
91628991|NCT05241470|183150309|SUPERIORITY|||||||0.0332|||||||ANCOVA|||||||0.0332
91628992|NCT05241470|183150310|SUPERIORITY|||||||0.0394|||||||t-test, 2 sided|||||||0.0394
91628993|NCT05241470|183150311|SUPERIORITY|||||||0.0121|||||||Wilcoxon (Mann-Whitney)|||||||0.0121
91628994|NCT05241470|183150312|SUPERIORITY|||||||0.0224|||||||Wilcoxon (Mann-Whitney)|||||||0.0224
91628995|NCT06048809|183150317|OTHER|||||||2.36e-05|||||||ANCOM-BC2|||Haemophilus parainfluenzae: Change From Baseline at Week 6||||0.0000236
91628996|NCT06048809|183150317|OTHER|||||||0.0033243|||||||ANCOM-BC2|||Neisseria elongata: Change From Baseline at Week 6||||0.0033243
91628997|NCT06048809|183150317|OTHER|||||||0.00500088|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_898: Change From Baseline at Week 6||||0.00500088
91628998|NCT06048809|183150317|OTHER|||||||0.0066975|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_110: Change From Baseline at Week 6||||0.0066975
91628999|NCT06048809|183150317|OTHER|||||||0.00710228|||||||ANCOM-BC2|||Aggregatibacter aphrophilus: Change From Baseline at Week 6||||0.00710228
91629000|NCT06048809|183150317|OTHER|||||||0.00744022|||||||ANCOM-BC2|||Kingella oralis: Change From Baseline at Week 6||||0.00744022
91629001|NCT06048809|183150317|OTHER|||||||0.01434037|||||||ANCOM-BC2|||Haemophilus sp.\_HMT\_036: Change From Baseline at Week 6||||0.01434037
91629002|NCT06048809|183150317|OTHER|||||||0.01955327|||||||ANCOM-BC2|||Haemophilus haemolyticus: Change From Baseline at Week 6||||0.01955327
91629003|NCT06048809|183150317|OTHER|||||||0.01995277|||||||ANCOM-BC2|||Neisseria mucosa: Change From Baseline at Week 6||||0.01995277
91629004|NCT06048809|183150317|OTHER|||||||0.02082528|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_393\_nov\_97.053%: Change From Baseline at Week 6||||0.02082528
91629005|NCT06048809|183150317|OTHER|||||||0.02188156|||||||ANCOM-BC2|||Ottowia sp.\_HMT\_894: Change from Baseline at Week 6||||0.02188156
91629006|NCT06048809|183150317|OTHER|||||||0.02321733|||||||ANCOM-BC2|||Cryptobacterium curtum: Change From Baseline at Week 6||||0.02321733
91629007|NCT06048809|183150317|OTHER|||||||0.02397996|||||||ANCOM-BC2|||Lautropia mirabilis: Change from Baseline at Week 6||||0.02397996
91629008|NCT06048809|183150317|OTHER|||||||0.02509094|||||||ANCOM-BC2|||Haemophilus paraphrohaemolyticus: Change From Baseline at Week 6||||0.02509094
91664800|NCT00112437|183222885|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.69|||<=|0.001|TWO_SIDED|95.0|3.25|6.12||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||6.12|3.25|<=0.001
91664801|NCT00112437|183222885|SUPERIORITY_OR_OTHER||Difference in Least Square Means|3.57|||<=|0.001|TWO_SIDED|95.0|2.18|4.97||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.97|2.18|<=0.001
91482827|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.2234|TWO_SIDED|95.0|-4.58|1.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.09|-4.58|0.2234
91525544|NCT00116272|182926306|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|21.79|||||TWO_SIDED|95.0|-83.32|126.91|||||Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.|||126.91|-83.32|
91629009|NCT06048809|183150317|OTHER|||||||0.02648847|||||||ANCOM-BC2|||Capnocytophaga sp.\_HMT\_332: Change From Baseline at Week 6||||0.02648847
91629010|NCT06048809|183150317|OTHER|||||||0.02828764|||||||ANCOM-BC2|||Neisseria flavescens: Change From Baseline at Week 6||||0.02828764
91629011|NCT06048809|183150317|OTHER|||||||0.03454372|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_96.429%: Change From Baseline at Week 6||||0.03454372
91629012|NCT06048809|183150317|OTHER|||||||0.03747507|||||||ANCOM-BC2|||Capnocytophaga sputigena: Change From Baseline at Week 6||||0.03747507
91664802|NCT00112437|183222885|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.82|||<=|0.001|TWO_SIDED|95.0|1.39|4.25||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.25|1.39|<=0.001
91629013|NCT06048809|183150317|OTHER|||||||0.03776136|||||||ANCOM-BC2|||Haemophilus sputorum: Change From Baseline at Week 6||||0.03776136
91629014|NCT06048809|183150317|OTHER|||||||0.03853215|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_90.546%: Change From Baseline at Week 6||||0.03853215
91629015|NCT06048809|183150317|OTHER|||||||0.04751303|||||||ANCOM-BC2|||Prevotella denticola: Change From Baseline at Week 6||||0.04751303
91525545|NCT00116272|182926307|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.|||0.63|-0.44|
91525546|NCT00116272|182926308|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.43|0.26|||||Computed using linear regression, adjusted for maternal age (categorical).|||0.26|-0.43|
91629016|NCT06048809|183150317|OTHER|||||||0.05190512|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_513: Change From Baseline at Week 6||||0.05190512
91629017|NCT06048809|183150317|OTHER|||||||0.0550647|||||||ANCOM-BC2|||Veillonella sp.\_HMT\_780: Change From Baseline at Week 6||||0.0550647
91629018|NCT06048809|183150317|OTHER|||||||0.05861488|||||||ANCOM-BC2|||Neisseria perflava: Change From Baseline at Week 6||||0.05861488
91629019|NCT06048809|183150317|OTHER|||||||0.06727926|||||||ANCOM-BC2|||Slackia exigua: Change From Baseline at Week 6||||0.06727926
91629020|NCT06048809|183150317|OTHER|||||||0.07051698|||||||ANCOM-BC2|||Shuttleworthia satelles: Change from Baseline at Week 6||||0.07051698
91629021|NCT06048809|183150317|OTHER|||||||0.0740793|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_458: Change From Baseline at Week 6||||0.0740793
91629022|NCT06048809|183150317|OTHER|||||||0.07426973|||||||ANCOM-BC2|||Ruminococcaceae\_\[G-1\] bacterium\_HMT\_075: Change From Baseline at Week 6||||0.07426973
91629023|NCT06048809|183150317|OTHER|||||||0.07829888|||||||ANCOM-BC2|||Campylobacter showae: Change From Baseline at Week 6||||0.07829888
91629024|NCT06048809|183150317|OTHER|||||||0.08462924|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_056: Change From Baseline at Week 6||||0.08462924
91629025|NCT06048809|183150318|OTHER|||||||0.062378|||||||ANCOM-BC2|||Abiotrophia defectiva: Change from Baseline at Week 6||||0.062378
91629026|NCT06048809|183150318|OTHER|||||||0.063437|||||||ANCOM-BC2|||Saccharibacteria\_(TM7)\_\[G1\] bacterium\_HMT\_346: Change from Baseline at Week 6||||0.063437
91629027|NCT06048809|183150318|OTHER|||||||0.069908|||||||ANCOM-BC2|||Olsenella sp.\_HMT\_807: Change from Baseline at Week 6||||0.069908
91629028|NCT06048809|183150318|OTHER|||||||0.079736|||||||ANCOM-BC2|||Fusobacterium nucleatum\_nucleatum\_subsp.\_animalis: Change from Baseline at Week 6||||0.079736
91629029|NCT06048809|183150318|OTHER|||||||0.094642|||||||ANCOM-BC2|||Bergeyella sp.\_HMT\_322: Change from Baseline at Week 6||||0.094642
91629030|NCT06048809|183150318|OTHER|||||||0.095848|||||||ANCOM-BC2|||Peptostreptococcaceae\_\[XI\]\[G-1\] \[Eubacterium\]\_infirmum: Change from Baseline at Week 6||||0.095848
91664803|NCT00112437|183222885|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.41||||0.585|TWO_SIDED|95.0|-1.85|1.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||1.04|-1.85|0.585
91664804|NCT00112437|183222886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.09|||<=|0.001|TWO_SIDED|95.0|3.18|7.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||7.01|3.18|<=0.001
91664805|NCT00112437|183222886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.56|||<=|0.001|TWO_SIDED|95.0|2.7|6.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.42|2.70|<=0.001
91482828|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6186|TWO_SIDED|95.0|-3.52|2.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.12|-3.52|0.6186
91525547|NCT00116272|182926309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.22|1.05|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.05|0.22|
91629031|NCT06048809|183150318|OTHER|||||||0.107931|||||||ANCOM-BC2|||Prevotella sp.\_HMT\_317: Change from Baseline at Week 6||||0.107931
91629032|NCT06048809|183150318|OTHER|||||||0.109114|||||||ANCOM-BC2|||Bacteroidales\_\[G-2\] bacterium\_HMT\_274: Change from Baseline at Week 6||||0.109114
91629033|NCT06048809|183150318|OTHER|||||||0.11083|||||||ANCOM-BC2|||Actinomyces sp.\_HMT\_175\_nov 97.951%: Change from Baseline at Week 6||||0.11083
91629034|NCT06048809|183150318|OTHER|||||||0.120377|||||||ANCOM-BC2|||Slackia exigua: Change from Baseline at Week 6||||0.120377
91629035|NCT06048809|183150318|OTHER|||||||0.123758|||||||ANCOM-BC2|||Granulicatella adiacens: Change from Baseline at Week 6||||0.123758
91629036|NCT06048809|183150318|OTHER|||||||0.123992|||||||ANCOM-BC2|||Prevotella oris: Change from Baseline at Week 6||||0.123992
91692406|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Sqaure (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.12||||90.0|-4.2|2.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||2.8|-4.2|
91629037|NCT06048809|183150318|OTHER|||||||0.133385|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_064: Change from Baseline at Week 6||||0.133385
91629038|NCT06048809|183150318|OTHER|||||||0.144598|||||||ANCOM-BC2|||Schaalia odontolyticus: Change from Baseline at Week 6||||0.144598
91629039|NCT06048809|183150318|OTHER|||||||0.147278|||||||ANCOM-BC2|||Mogibacterium diversum: Change from Baseline at Week 6||||0.147278
91629040|NCT06048809|183150318|OTHER|||||||0.148674|||||||ANCOM-BC2|||Prevotella denticola: Change from Baseline at Week 6||||0.148674
91629041|NCT06048809|183150318|OTHER|||||||0.149722|||||||ANCOM-BC2|||Absconditabacteria\_(SR1)\_\[G-1\] bacterium\_HMT\_875: Change from Baseline at Week 6||||0.149722
91629042|NCT06048809|183150318|OTHER|||||||0.154465|||||||ANCOM-BC2|||Prevotella nigrescens: Change from Baseline at Week 6||||0.154465
91629043|NCT06048809|183150318|OTHER|||||||0.158139|||||||ANCOM-BC2|||Streptococcus chosunense: Change from Baseline at Week 6||||0.158139
91629044|NCT02658149|183150321|OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
91629045|NCT02658149|183150322|OTHER|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||||||0.204
91629046|NCT02658149|183150323|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91629047|NCT02658149|183150324|OTHER|||||||0.741|||||||t-test, 2 sided|||||||0.741
91629048|NCT02658149|183150325|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
91629049|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.9825|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.9825
91629050|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.5737|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5737
91629051|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.5703|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5703
91629052|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.5684|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5684
91664806|NCT00112437|183222886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.43|||<=|0.001|TWO_SIDED|95.0|2.52|6.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.33|2.52|<=0.001
91664807|NCT00112437|183222886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.04||||0.981|TWO_SIDED|95.0|-1.97|1.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||1.89|-1.97|0.981
91714191|NCT00243919|183320177|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<.0001
91714192|NCT00243919|183320178|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.||12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.13
91714193|NCT00243919|183320178|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.04
91629053|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.8235|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.8235
91629054|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.2384|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.2384
91629055|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.1634
91629056|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.7816|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.7816
91629057|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.3917|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.3917
91629058|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.1749|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.1749
91629059|NCT01156363|183150354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||<0.001
91629060|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0905|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.0905
91714194|NCT00243919|183320179|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
91714195|NCT00243919|183320179|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.001
91714196|NCT00243919|183320180|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.62
91629061|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.3766|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.3766
91629062|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0253
91629063|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0209
91629064|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.8206|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.8206
91629065|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0907|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0907
91629066|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0177
91629067|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0050
91629068|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.3724
91629069|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.2796|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.2796
91629070|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0066
91629071|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0081
91629072|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.7853
91629073|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.0039
91629074|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.3057|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3057
91629075|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.3374|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3374
91629076|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.1410
91629077|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0017
91629078|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0677|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0677
91629079|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.1608|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.1608
91629080|NCT01156363|183150354|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0196
91629081|NCT00617162|183150403|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.3989|TWO_SIDED|95.0|-5.5|2.2|||Fisher Exact|||||2.2|-5.5|0.3989
91525548|NCT00116272|182926310|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.31|1.68|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||1.68|0.31|
91629082|NCT00047008|183150428|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.18|TWO_SIDED|95.0|0.719|1.128|||Log Rank|||A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.||1.128|0.719|0.180
91629083|NCT00047008|183150429|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.76|TWO_SIDED|95.0|0.83|1.43||One-sided significance level = 0.05|Gray's test|||||1.43|0.83|0.76
91629084|NCT00047008|183150430|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8|TWO_SIDED|95.0|0.85|1.44||One-sided significance level = 0.05|Gray's test|||||1.44|0.85|0.80
91629085|NCT00047008|183150431|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.42|TWO_SIDED|95.0|0.81|1.2||One-sided significance level = 0.05|Log Rank|||||1.20|0.81|0.42
91629086|NCT00047008|183150432|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.81|1.23||One-sided significance level = 0.05|Log Rank|||||1.23|0.81|0.50
91629087|NCT00047008|183150433|SUPERIORITY|||||||0.21||||||Two-side significance level = 0.05|Fisher Exact|||Acute toxicity||||0.21
91664808|NCT00112437|183222887|SUPERIORITY_OR_OTHER||Difference in Least square means|1.73|||<=|0.001||95.0|0.46|3.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||3.01|0.46|<=0.001
91629088|NCT00047008|183150433|SUPERIORITY|||||||0.18||||||Two-sided significance level = 0.05|Fisher Exact|||Late toxicity||||0.18
91629089|NCT00047008|183150434|SUPERIORITY|||||||0.92||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.92
91629090|NCT00047008|183150435|SUPERIORITY|||||||0.67||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.67
91629091|NCT00047008|183150436|SUPERIORITY|||||||0.43||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.43
91629092|NCT00047008|183150437|SUPERIORITY|||||||0.39||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.39
91629093|NCT01665872|183150445|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.172|||||||t-test, 2 sided|||||||0.172
91629094|NCT01665872|183150446|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.5337|||||||Wilcoxon (Mann-Whitney)|||Are CES-D scores at 12 months different between groups?||||0.5337
91629095|NCT01665872|183150447|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.092||||||This test looks at a difference in Parental Distress at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0920
91629096|NCT01665872|183150447|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.3352||||||This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.3352
91629097|NCT01665872|183150447|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0404||||||This test looks at a difference in Difficult Child at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0404
91525549|NCT00116272|182926311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.4|1.57|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.57|0.40|
91629098|NCT01665872|183150447|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0915||||||This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0915
91714197|NCT00243919|183320180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
91714198|NCT02157519|183320211|SUPERIORITY||Odds Ratio (OR)|0.56||||0.186|TWO_SIDED|95.0|0.23|1.33||threshold p \<0.05|Regression, Logistic|Adjusted for baseline MMAS-4 scores (dichotomous) and change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.||1.33|0.23|0.186
91525550|NCT00116272|182926312|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.2|||||TWO_SIDED|95.0|-7.59|7.99|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake \& 32 weeks, disease severity imputation indicators|||7.99|-7.59|
91629099|NCT01665872|183150448|EQUIVALENCE|Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.||||||0.2914|||||||Chi-squared|||||||0.2914
91629100|NCT02773368|183150450|NON_INFERIORITY|Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.|Treatment Contrast|-0.34|||||TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA||IDegLira minus IGlar|Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.||-0.20|-0.48|
91629101|NCT02773368|183150450|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.|Treatment Contrast|-0.36|||||TWO_SIDED|95.0|-0.5|-0.21|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-0.21|-0.50|
91629102|NCT02773368|183150451|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.|Treatment Contrast|-1.92|||||TWO_SIDED|95.0|-2.64|-1.19|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-1.19|-2.64|
91629103|NCT02773368|183150452|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.|Treatment Ratio|0.42|||||TWO_SIDED|95.0|0.23|0.75|||Negative binomial regression model||IDegLira over IGlar|This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).||0.75|0.23|
91629104|NCT02773368|183150453|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.|Treatment Contrast|-15.37|||||TWO_SIDED|95.0|-19.6|-11.13|||ANCOVA||IDegLira minus IGlar|The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-11.13|-19.60|
91629105|NCT01929018|183150484|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.87
91629106|NCT01929018|183150484|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.38
91629107|NCT01929018|183150485|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.75
91629108|NCT01929018|183150485|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.11
91482829|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.5853|TWO_SIDED|95.0|-3.6|2.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.06|-3.60|0.5853
91629109|NCT01929018|183150486|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.11
91629110|NCT01929018|183150486|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.23
91629111|NCT01929018|183150487|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.27
91629112|NCT01929018|183150487|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.58
91629113|NCT01929018|183150488|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.83
91629114|NCT01929018|183150488|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.13
91629115|NCT01929018|183150489|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
91629116|NCT01929018|183150489|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.02
91629117|NCT01929018|183150490|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
91629118|NCT01929018|183150490|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.06
91629119|NCT01929018|183150491|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.62
91629120|NCT01929018|183150491|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.40
91629121|NCT01929018|183150492|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.96
91664809|NCT00112437|183222887|SUPERIORITY_OR_OTHER||Difference in Least square means|1.11||||0.028||95.0|-0.12|2.34||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||2.34|-0.12|0.028
91525551|NCT00116272|182926313|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|1.53|||||TWO_SIDED|95.0|-5.76|8.81|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).|||8.81|-5.76|
91664810|NCT00112437|183222887|SUPERIORITY_OR_OTHER||Difference in Least square means|0.2||||0.804||95.0|-1.1|1.49||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||1.49|-1.10|0.804
91629122|NCT01929018|183150492|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.35
91629123|NCT01047436|183150500|SUPERIORITY_OR_OTHER||difference between treatments|26.7||||0.17|TWO_SIDED|95.0|-0.3|53.7|||Fisher Exact|||The sample size was not statistically determined in this initial trial with ArTimist. For the primary outcome analysis, the percentage of patients defined as having success were determined. The difference between ArTiMist and quinine, along with its 95% confidence interval (CI) were determined. The difference between treatments were compared using Fisher's Exact test||53.7|-0.3|0.17
91629124|NCT01047436|183150502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.48|3.01|||Log Rank|||The time for the parasite count to fall by 90% (PCT90) was determined for each patient as the time in minutes/seconds, when the parasite count fell by 90% The PCT90 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||3.01|0.48|0.70
91629125|NCT01047436|183150504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.76||95.0|0.34|2.18||Difference between survival curves compared by Log Rank test|Log Rank|||The PCT50 was determined for each patient as the time in minutes/seconds, when the parasite count fell by 50% The PCT50 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||2.18|0.34|0.76
91629126|NCT01789255|183150514|OTHER|||||||0.02642|||||||Wilcoxon (Mann-Whitney)|||||||0.02642
91629127|NCT01789255|183150515|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91629128|NCT02635867|183150516|SUPERIORITY|Descriptive data and rates of success were calculated independently for indirect and direct therapies. Statistical analyses of proportions were done using Fisher's test and 95% confidence intervals (CI)|||||>|0.1|||||||Fisher Exact|||"The clinical outcome measures assessed were pain using visual analog pain scale, pulp vitality assessment at 12 months.~The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital:~Vital: palpation = negative/ percussion = negative/ response to cold stimuli= positive response Non vital: palpation = positive / percussion = positive. / response to cold stimuli= positive or delayed response time in seconds and lingering."||||>0.1
91629129|NCT02128958|183150518|OTHER|||||||0.536|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Overall Survival will be performed using the log rank test as the primary analysis.||||0.536
91629130|NCT02128958|183150519|OTHER|||||||0.371|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Time to Progression will be performed using the log rank test as the primary analysis.||||.371
91629131|NCT02128958|183150520|OTHER|||||||0.521|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) will be performed on Time to Progression Free Survival using the logrank test.||||0.521
91664811|NCT00112437|183222887|SUPERIORITY_OR_OTHER||Difference in Least square means|-1.15|||||TWO_SIDED|95.0|-2.46|0.15||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||0.15|-2.46|
91664812|NCT00112437|183222888|SUPERIORITY_OR_OTHER||Difference in Least square means|2.9|||<=|0.001|TWO_SIDED|95.0|1.34|4.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||4.46|1.34|<=0.001
91664813|NCT00112437|183222888|SUPERIORITY_OR_OTHER||Difference in Least square means|2.09|||<=|0.001||95.0|0.59|3.6||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.60|0.59|<=0.001
91714199|NCT02157519|183320212|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|4.06||0.57|TWO_SIDED|95.0|-10.35|5.68||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||5.68|-10.35|0.57
91714200|NCT02157519|183320213|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.603|TWO_SIDED|95.0|-0.31|0.53||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.53|-0.31|0.603
91714201|NCT02157519|183320213|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.982|TWO_SIDED|95.0|-0.64|0.65||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.||0.65|-0.64|0.982
91482830|NCT01227564|182839158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.5541|TWO_SIDED|95.0|-3.23|1.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.75|-3.23|0.5541
91525552|NCT00116272|182926314|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.27|||||TWO_SIDED|95.0|-6.12|6.65|||||Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.|||6.65|-6.12|
91629132|NCT02128958|183150523|OTHER|||||||0.988|||||||ANCOVA|||Between-treatment comparisons of ALT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.988
91629133|NCT02128958|183150523|OTHER|||||||0.989|||||||ANCOVA|||Between-treatment comparisons of AST will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.989
91629134|NCT02128958|183150523|OTHER|||||||0.717|||||||ANCOVA|||Between-treatment comparisons of Albumin will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.717
91629135|NCT02128958|183150523|OTHER|||||||0.891|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (direct) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.891
91629136|NCT02128958|183150523|OTHER|||||||0.275|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (Total) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.275
91664814|NCT00112437|183222888|SUPERIORITY_OR_OTHER||Difference in Least square means|1.53||||0.094||95.0|-0.01|3.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.07|-0.01|0.094
91664815|NCT00112437|183222888|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.95||||||95.0|-4.5|-1.4||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||-1.40|-4.50|
91664816|NCT00112437|183222889|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-47.21|||<=|0.001||95.0|-64.51|-29.9||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-29.90|-64.51|<=0.001
91664817|NCT00112437|183222889|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-33.67|||<=|0.001||95.0|-51.44|-15.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-15.91|-51.44|<=0.001
91664818|NCT00112437|183222889|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.94|||<=|0.001||95.0|-54.15|-17.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-17.74|-54.15|<=0.001
91692407|NCT03187301|183279689|NON_INFERIORITY|15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.3|8.6||||||||8.6|0.3|
91714202|NCT02157519|183320214|SUPERIORITY||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.65||0.144|TWO_SIDED|95.0|-5.66|0.83||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.83|-5.66|0.144
91629137|NCT02128958|183150523|OTHER|||||||0.549|||||||ANCOVA|||Between-treatment comparisons of PT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.549
91792094|NCT03036800|183461950|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.14|-3.25|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.25|-6.14|<0.001
91629138|NCT02128958|183150523|OTHER|||||||0.479|||||||ANCOVA|||Between-treatment comparisons of INR will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.479
91629139|NCT02565576|183150531|SUPERIORITY||estimate of contrast posterior median|-1.14|||||TWO_SIDED|90.0|-3.41|1.14|||bayesian|||Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.||1.14|-3.41|
91525553|NCT00116272|182926315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.37|1.62|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.|||1.62|0.37|
91629140|NCT00282568|183150542|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|94.97|||||TWO_SIDED|90.0|90.72|99.41|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||99.41|90.72|
91629141|NCT00282568|183150544|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.15|||||TWO_SIDED|90.0|82.69|93.96|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmax. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmax prior to analysis and the results were transformed back to the original scale for the presentation of results.||93.96|82.69|
91629142|NCT00282568|183150545|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|87.2|||||TWO_SIDED|90.0|82.72|91.93|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||91.93|82.72|
91629143|NCT00796003|183150601|SUPERIORITY_OR_OTHER||Overall Response Rate|26.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|90.0|14.6|41.6|||Binomial test|one-tailed 5% level at a significance level||Null Hypothesis: Overall Remission Rate = 5%||41.6|14.6|<0.0001
91629144|NCT03185819|183150613|SUPERIORITY||Difference of LS Means|-5.8|STANDARD_ERROR_OF_MEAN|2.74|=|0.037|TWO_SIDED|95.0|-11.19|-0.35||Threshold for significance for p-value was 0.05.|ANCOVA|||A pooled (54 mg and 84 mg) sequential multiple testing procedure was implemented to control type I error by comparing pooled data against midazolam + placebo matched to esketamine nasal spray.||-0.35|-11.19|= 0.037
91629145|NCT03185819|183150613|SUPERIORITY||Difference of LS Mean|-5.7|STANDARD_ERROR_OF_MEAN|3.65|=|0.123|TWO_SIDED|95.0|-12.91|1.55||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (84 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||1.55|-12.91|= 0.123
91629146|NCT03185819|183150613|SUPERIORITY||Difference of LS Means|-5.9|STANDARD_ERROR_OF_MEAN|3.23|=|0.072|TWO_SIDED|95.0|-12.25|0.53||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (56 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||0.53|-12.25|= 0.072
91691982|NCT00380874|183278455|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.49||0.7489||95.0||||No multiple comparisons adjustment was necessary.|ANCOVA|Model terms include treatment, study center, and baseline score.|Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.|LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects \& 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.||||0.7489
91525554|NCT00116272|182926316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.43|3.14|||||Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.|||3.14|0.43|
91629147|NCT03185819|183150613|SUPERIORITY||Difference of LS Means|-2.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-9.08|4.19||||||||4.19|-9.08|
91629148|NCT02910089|183150621|SUPERIORITY|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.2|0.32||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function (as a continuous variable) and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|||0.32|-0.2|
91629149|NCT02910089|183150622|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.42|4.4||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|Average of the percentage (proportion x 100) of days covered across all subjects.||4.40|-2.42|
91714203|NCT02157519|183320214|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.294|TWO_SIDED|95.0|-2.0|0.61||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.||0.61|-2.00|0.294
91525555|NCT00116272|182926317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.29|2.65|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||2.65|0.29|
91525556|NCT00116272|182926318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.47|4.02|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||4.02|0.47|
91629150|NCT02910089|183150623|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.83|1.28||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with a logit link and binary distributed errors||||1.28|0.83|
91629151|NCT02910089|183150624|OTHER|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.17||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|See comments|Generalized Estimating Equations with a logit link and binary distributed errors||||1.17|0.71|
91629152|NCT03434041|183150628|SUPERIORITY||Difference of Least Square (LS) Means|-2.0||||0.123|TWO_SIDED|95.0|-4.64|0.55||2-sided|Mixed-effects Model for Repeated Measure|||||0.55|-4.64|0.123
91629153|NCT03434041|183150629|SUPERIORITY||Difference of LS Means|-3.3|||||TWO_SIDED|95.0|-5.33|-1.33||||||||-1.33|-5.33|
91629154|NCT03434041|183150630|SUPERIORITY||Difference of LS Means|-1.0|||||TWO_SIDED|95.0|-2.96|0.97||||||||0.97|-2.96|
91629155|NCT02977507|183150648|OTHER|||||||0.041|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.041
91629156|NCT02977507|183150648|OTHER|||||||0.0005|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0005
91629157|NCT02977507|183150649|OTHER|||||||0.002|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.002
91629158|NCT02977507|183150649|OTHER|||||||0.0001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0001
91664819|NCT00112437|183222889|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|17.51||||0.101|TWO_SIDED|95.0|-6.78|41.8||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||41.80|-6.78|0.101
91629159|NCT02977507|183150650|OTHER|||||||0.004|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.004
91691983|NCT03380429|183278456|SUPERIORITY||Mean Difference (Final Values)|12.0|||<|0.001|TWO_SIDED|95.0|5.2|18.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||18.8|5.2|<0.001
91629160|NCT02977507|183150650|OTHER|||||||0.001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.001
91525557|NCT00116272|182926320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.65|1.69|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||1.69|0.65|
91629161|NCT02977507|183150654|OTHER|||||||0.003|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.003
91691984|NCT03380429|183278457|OTHER||Mean Difference (Final Values)|8.2||||0.016|TWO_SIDED|95.0|1.6|14.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.9|1.6|0.016
91527802|NCT01678820|182930637|SUPERIORITY_OR_OTHER||Difference in least squares means|0.5||||0.857|TWO_SIDED|95.0|-4.8|5.8|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.8|-4.8|0.857
91629162|NCT02977507|183150654|OTHER|||||||0.0007|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0007
91629163|NCT02977507|183150656|OTHER|||||||0.569|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.569
91629164|NCT02977507|183150656|OTHER|||||||9e-05|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.00009
91629165|NCT02977507|183150656|OTHER|||||||0.821|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.821
91629166|NCT02977507|183150656|OTHER|||||||0.502|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.502
91629167|NCT02977507|183150656|OTHER|||||||0.81|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.810
91629168|NCT02977507|183150656|OTHER|||||||0.435|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.435
91629169|NCT00856986|183150686|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.52||||||95.0|-0.68|-0.36|||ANCOVA|||The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.||-0.36|-0.68|
91691985|NCT03380429|183278457|OTHER||Mean Difference (Final Values)|9.3||||0.006|TWO_SIDED|95.0|2.7|16.0||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.0|2.7|0.006
91691986|NCT03380429|183278457|OTHER||Mean Difference (Final Values)|8.1||||0.018|TWO_SIDED|95.0|1.4|14.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.8|1.4|0.018
91691987|NCT03380429|183278458|OTHER||Mean Difference (Final Values)|9.3||||0.003|TWO_SIDED|95.0|3.2|15.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||15.3|3.2|0.003
91629170|NCT00856986|183150687|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.41||||||95.0|-0.6|-0.21|||ANCOVA||The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.|The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.||-0.21|-0.6|
91629171|NCT00856986|183150688|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS mean|-0.51||||||95.0|-0.7|-0.31|||ANCOVA||The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects|||-0.31|-0.7|
91629172|NCT01906476|183150726|NON_INFERIORITY|Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, \& Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, \& Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.|||||||||||||||||"Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:~Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)"|||
91629173|NCT01906476|183150727|SUPERIORITY||ICER estimate|-152.55|||||TWO_SIDED|95.0|-1143.09|1094.72||||||We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.||1094.72|-1143.09|
91629174|NCT01248585|183150729|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.053||0.05|TWO_SIDED|90.0|0.0|0.177||1-sided p-value.|Cochran-Mantel-Haenszel|||One-sided 0.05 level test with 90% power, 298 participants required.||0.177|0|0.05
91629175|NCT01248585|183150730|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.009||||0.432|TWO_SIDED|95.0|-0.08|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.08|0.432
91629176|NCT01248585|183150732|SUPERIORITY||Risk Difference (RD)|0.09||||0.15|TWO_SIDED|90.0|0.01|0.18||Fisher exact test.|Fisher Exact|||||0.18|0.01|0.15
91629177|NCT01248585|183150733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.07|TWO_SIDED|90.0|-5.06|3.97|||Wilcoxon (Mann-Whitney)|||||3.97|-5.06|0.07
91629178|NCT02448914|183150736|NON_INFERIORITY_OR_EQUIVALENCE|Analysis was first to attempt to show non-inferiority. To show non-inferiority of TRIGEL over Duodopa, the lower limit of the two-sided CI for the treatment ratio had to be above the chosen non-inferiority margin of 0.9. If non-inferiority was shown, analysis continued with test of superiority. To show superiority of TRIGEL versus Duodopa, the lower confidence limit had to be above 1 (corresponding to a p-value less than 0.05).|back-transformed ratio|1.382|||<|0.0001|TWO_SIDED|95.0|1.264|1.511|||ANCOVA|||Levodopa AUC 0-14h/dose, was derived using the trapezoidal method and divided by the total administered dose of levodopa during the corresponding time interval.The primary endpoint was log transformed and analysed using an ANCOVA, adjusting for treatment, period and patient. The back-transformed ratio of TRIGEL over Duodopa was calculated together with 95% confidence intervals (CI) and the associated (2 sided) p value.||1.511|1.264|<0.0001
91629179|NCT01576406|183150767|SUPERIORITY||Geometric mean ratio|91.2|||||TWO_SIDED|90.0|57.47|144.72||||||Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.||144.72|57.47|
91629180|NCT01576406|183150767|SUPERIORITY||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|89.11|232.12||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||232.12|89.11|
91629181|NCT01576406|183150767|SUPERIORITY||Geometric mean ratio|108.87|||||TWO_SIDED|90.0|70.13|168.99||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||168.99|70.13|
91629182|NCT01576406|183150767|SUPERIORITY||Geometric mean ratio|72.63|||||TWO_SIDED|90.0|49.07|107.5||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||107.50|49.07|
91629183|NCT01576406|183150793|SUPERIORITY||Percentage of ratio of geometric mean|91.12|||||TWO_SIDED|90.0|56.56|146.79||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||146.79|56.56|
91629184|NCT01576406|183150793|SUPERIORITY||Percentage of ratio of geometric mean|149.54|||||TWO_SIDED|90.0|91.85|243.46||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||243.46|91.85|
91629185|NCT01576406|183150793|SUPERIORITY||Percentage of ratio of geometric mean|114.08|||||TWO_SIDED|90.0|73.57|176.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||176.89|73.57|
91691988|NCT03380429|183278458|OTHER||Mean Difference (Final Values)|7.7||||0.011|TWO_SIDED|95.0|1.8|13.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.7|1.8|0.011
91629186|NCT01576406|183150793|SUPERIORITY||Percentage of ratio of geometric mean|64.67|||||TWO_SIDED|90.0|39.5|105.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||105.89|39.50|
91629187|NCT01576406|183150794|SUPERIORITY||Percentage of ratio of geometric mean|108.43|||||TWO_SIDED|90.0|63.47|185.26||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||185.26|63.47|
91629188|NCT01576406|183150794|SUPERIORITY||Percentage of ratio of geometric mean|202.89|||||TWO_SIDED|90.0|120.96|340.3||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||340.30|120.96|
91629189|NCT01576406|183150794|SUPERIORITY||Percentage of ratio of geometric mean|130.78|||||TWO_SIDED|90.0|86.61|197.47||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||197.47|86.61|
91629190|NCT01576406|183150794|SUPERIORITY||Percentage of ratio of geometric mean|62.82|||||TWO_SIDED|90.0|42.54|92.78||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||92.78|42.54|
91629191|NCT01627782|183150806|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.0|||<|0.001|TWO_SIDED|70.0|-20.0|-12.01|||Mixed Effect Model Repeated Measure|||||-12.01|-20.00|< 0.001
91629192|NCT01627782|183150806|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.4|||<|0.001|TWO_SIDED|70.0|-18.96|-13.84|||Mixed Effect Model Repeated Measure|||||-13.84|-18.96|< 0.001
91482831|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.937|TWO_SIDED|95.0|-2.09|1.93||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.93|-2.09|0.9370
91629193|NCT00142818|183150835|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.4
91664820|NCT00112437|183222890|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-63.34|||<=|0.001||95.0|-88.32|-38.36||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-38.36|-88.32|<=0.001
91664821|NCT00112437|183222890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-39.29|||<=|0.001|TWO_SIDED|95.0|-65.4|-13.18||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-13.18|-65.40|<=0.001
91664822|NCT00112437|183222890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-23.98||||0.124|TWO_SIDED|95.0|-53.04|5.09||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||5.09|-53.04|0.124
91664823|NCT00112437|183222890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.18|||||TWO_SIDED|95.0|-12.38|56.73|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||56.73|-12.38|
91664824|NCT00112437|183222891|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.71||||0.015||95.0|-36.03|2.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||2.61|-36.03|0.015
91714204|NCT02157519|183320214|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.74||0.025|TWO_SIDED|95.0|-3.12|-0.21||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||-0.21|-3.12|0.025
91714205|NCT02157519|183320214|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.58||0.392|TWO_SIDED|95.0|-0.64|1.63||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||1.63|-0.64|0.392
91527803|NCT01678820|182930637|SUPERIORITY_OR_OTHER||Difference in least squares means|0.4||||0.879|TWO_SIDED|95.0|-4.8|5.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.6|-4.8|0.879
91629194|NCT04315298|183150857|SUPERIORITY||LS Mean (log scale)|-1.25|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.456|-1.035||P-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.035|-1.456|<0.0001
91629195|NCT04315298|183150857|SUPERIORITY||LS Mean (log scale)|-1.3|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.511|-1.09||p-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.090|-1.511|<0.0001
91482832|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2597|TWO_SIDED|95.0|-3.19|0.88||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.88|-3.19|0.2597
91629196|NCT04315298|183150858|SUPERIORITY||Risk Difference (RD)|7.1||||0.3707|TWO_SIDED|95.0|-8.4|21.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.7|-8.4|0.3707
91629197|NCT04315298|183150858|SUPERIORITY||Risk Difference (RD)|7.5||||0.3261|TWO_SIDED|95.0|-7.4|21.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.3|-7.4|0.3261
91629198|NCT04315298|183150859|SUPERIORITY||Risk Difference (RD)|6.2||||0.7328|TWO_SIDED|95.0|-26.2|36.8|||Cochran-Mantel-Haenszel|P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline||||36.8|-26.2|0.7328
91629199|NCT04315298|183150860|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5687|TWO_SIDED|95.0|0.76|1.66||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.66|0.76|0.5687
91629200|NCT04315298|183150860|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7014|TWO_SIDED|95.0|0.74|1.62||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.62|0.74|0.7014
91629201|NCT04315298|183150861|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3622|TWO_SIDED|95.0|0.83|1.7||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.70|0.83|0.3622
91629202|NCT04315298|183150861|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.5802|TWO_SIDED|95.0|0.79|1.63||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.63|0.79|0.5802
91664825|NCT00112437|183222891|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-8.51||||0.246||95.0|-27.31|10.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||10.29|-27.31|0.246
91629203|NCT04315298|183150862|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.234|TWO_SIDED|95.0|0.83|2.02||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.83|0.2340
91629204|NCT04315298|183150862|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6949|TWO_SIDED|95.0|0.74|1.79||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.79|0.74|0.6949
91629205|NCT04315298|183150863|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.3151|TWO_SIDED|95.0|0.66|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||2.43|0.66|0.3151
91629206|NCT04315298|183150863|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.1884|TWO_SIDED|95.0|0.39|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.41|0.39|0.1884
91629207|NCT04315298|183150863|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.4356|TWO_SIDED|95.0|0.76|3.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||3.40|0.76|0.4356
91629208|NCT04315298|183150863|SUPERIORITY||Hazard Ratio (HR)|2.1||||0.0371|TWO_SIDED|95.0|1.01|4.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||4.40|1.01|0.0371
91629209|NCT04315298|183150863|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8923|TWO_SIDED|95.0|0.32|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||3.05|0.32|0.8923
91629210|NCT04315298|183150863|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.694|TWO_SIDED|95.0|0.25|2.71||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.71|0.25|0.6940
91629211|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|2.14||||0.0832|TWO_SIDED|95.0|0.81|5.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||5.65|0.81|0.0832
91629212|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|1.93||||0.1369|TWO_SIDED|95.0|0.77|4.8||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||4.80|0.77|0.1369
91629213|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.9636|TWO_SIDED|95.0|0.28|1.95||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||1.95|0.28|0.9636
91629214|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0038|TWO_SIDED|95.0|0.08|0.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||0.74|0.08|0.0038
91629215|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.738|TWO_SIDED|95.0|0.47|3.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 166.68pg/mL (Median)||3.13|0.47|0.7380
91664826|NCT00112437|183222891|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-1.79||||||95.0|-22.66|19.08|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||19.08|-22.66|
91664827|NCT00112437|183222891|SUPERIORITY_OR_OTHER||Difference in Least Square Means|21.74||||||95.0|-1.32|44.81|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||44.81|-1.32|
91664828|NCT00112437|183222892|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.64||||0.002||95.0|-28.84|-4.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||-4.44|-28.84|0.002
91691989|NCT03380429|183278458|OTHER||Mean Difference (Final Values)|5.5||||0.066|TWO_SIDED|95.0|-0.4|11.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||11.4|-0.4|0.066
91482833|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.4852|TWO_SIDED|95.0|-2.38|1.14||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.14|-2.38|0.4852
91525558|NCT05096208|182926324|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.858|1.169|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in least-square (LS) means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.169|0.858|
91527804|NCT01678820|182930638|SUPERIORITY_OR_OTHER||Difference in least squares means|-30.4||||0.004|TWO_SIDED|95.0|-51.0|-9.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-9.7|-51.0|0.004
91629216|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7342|TWO_SIDED|95.0|0.48|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \<166.68pg/mL (Median)||3.05|0.48|0.7342
91629217|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|3.58||||0.1934|TWO_SIDED|95.0|0.79|16.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||16.17|0.79|0.1934
91629218|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|5.33||||0.0159|TWO_SIDED|95.0|1.19|23.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||23.94|1.19|0.0159
91629219|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6281|TWO_SIDED|95.0|0.13|8.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||8.75|0.13|0.6281
91629220|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.4971|TWO_SIDED|95.0|0.06|6.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||6.13|0.06|0.4971
91629221|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.299|TWO_SIDED|95.0|0.03|2.86||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||2.86|0.03|0.2990
91629222|NCT04315298|183150864|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.936|TWO_SIDED|95.0|0.22|4.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||4.41|0.22|0.9360
91691990|NCT03380429|183278458|OTHER||Mean Difference (Final Values)|2.8||||0.359|TWO_SIDED|95.0|-3.1|8.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||8.7|-3.1|0.359
91629223|NCT04315298|183150865|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.9032|TWO_SIDED|95.0|0.52|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.47|0.52|0.9032
91629224|NCT04315298|183150865|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0052|TWO_SIDED|95.0|0.29|0.88||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.88|0.29|0.0052
91629225|NCT04315298|183150865|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.1168|TWO_SIDED|95.0|0.48|1.21||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.21|0.48|0.1168
91482834|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.4542|TWO_SIDED|95.0|-2.69|1.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.22|-2.69|0.4542
91629226|NCT04315298|183150865|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3753|TWO_SIDED|95.0|0.69|1.72||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.72|0.69|0.3753
91629227|NCT04315298|183150865|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4956|TWO_SIDED|95.0|0.4|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.66|0.40|0.4956
91629228|NCT04315298|183150865|SUPERIORITY||Cox Proportional Hazard|1.01||||0.8439|TWO_SIDED|95.0|0.5|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.02|0.50|0.8439
91629229|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.389|TWO_SIDED|95.0|0.52|2.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||2.79|0.52|0.3890
91629230|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.7838||95.0|0.3|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||1.41|0.30|0.7838
91629231|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.237|TWO_SIDED|95.0|0.28|1.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||1.65|0.28|0.2370
91629232|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.25||||0.0004||95.0|0.1|0.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||0.59|0.10|0.0004
91629233|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.174|TWO_SIDED|95.0|0.37|1.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.32|0.37|0.1740
91629234|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3664|TWO_SIDED|95.0|0.38|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||1.66|0.38|0.3664
91629235|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7318|TWO_SIDED|95.0|0.53|1.87||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.87|0.53|0.7318
91629236|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4155|TWO_SIDED|95.0|0.59|2.37||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||2.37|0.59|0.4155
91629237|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.6262|TWO_SIDED|95.0|0.23|2.45||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.45|0.23|0.6262
91629238|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.553||95.0|0.21|2.3||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.30|0.21|0.5530
91527805|NCT01678820|182930638|SUPERIORITY_OR_OTHER||Difference in least squares means|-15.3||||0.141|TWO_SIDED|95.0|-35.8|5.1|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.1|-35.8|0.141
91527806|NCT01678820|182930639|SUPERIORITY_OR_OTHER||Difference in percents|0.3|||||TWO_SIDED|95.0|-12.2|12.9|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple impuattions.|||12.9|-12.2|
91629239|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.8775|TWO_SIDED|95.0|0.25|2.85||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.85|0.25|0.8775
91629240|NCT04315298|183150866|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7485|TWO_SIDED|95.0|0.41|2.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.99|0.41|0.7485
91629241|NCT04315298|183150867|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.4556|TWO_SIDED|95.0|0.63|1.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.79|0.63|0.4556
91629242|NCT04315298|183150867|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0248|TWO_SIDED|95.0|0.35|1.04||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.04|0.35|0.0248
91629243|NCT04315298|183150867|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.6842|TWO_SIDED|95.0|0.62|1.67||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.67|0.62|0.6842
91629244|NCT04315298|183150867|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.0671|TWO_SIDED|95.0|0.89|2.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.32|0.89|0.0671
91629245|NCT04315298|183150867|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.6146|TWO_SIDED|95.0|0.41|1.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.74|0.41|0.6146
91629246|NCT04315298|183150867|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.973|TWO_SIDED|95.0|0.48|1.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.99|0.48|0.9730
91714206|NCT02157519|183320214|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.6||0.216|TWO_SIDED|95.0|-1.94|0.44||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.44|-1.94|0.216
91714207|NCT02157519|183320215|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.17|TWO_SIDED|95.0|-0.93|0.17||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.17|-0.93|0.170
91525559|NCT05096208|182926324|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.215|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.215|0.900|
91525560|NCT05096208|182926324|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.886|1.232|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.232|0.886|
91629247|NCT04315298|183150869|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.6987|TWO_SIDED|95.0|0.59|1.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.59|0.59|0.6987
91629248|NCT04315298|183150869|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0453|TWO_SIDED|95.0|0.39|1.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.09|0.39|0.0453
91629249|NCT04315298|183150869|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.9734|TWO_SIDED|95.0|0.73|2.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.09|0.73|0.9734
91629250|NCT04315298|183150869|SUPERIORITY||Hazard Ratio (HR)|1.91||||0.004|TWO_SIDED|95.0|1.14|3.2||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No)|Log Rank|||Disease Severity: Critical||3.20|1.14|0.0040
91629251|NCT04315298|183150869|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9551|TWO_SIDED|95.0|0.43|2.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.17|0.43|0.9551
91629252|NCT04315298|183150869|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8722|TWO_SIDED|95.0|0.42|2.1||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.10|0.42|0.8722
91629253|NCT04315298|183150872|SUPERIORITY|||||||1|||||||Chi-squared|||Disease Severity: Severe||||1.0000
91629254|NCT04315298|183150872|SUPERIORITY|||||||0.0353|||||||Chi-squared|||Disease Severity: Severe||||0.0353
91629255|NCT04315298|183150872|SUPERIORITY|||||||0.3187|||||||Chi-squared|||Disease Severity: Critical||||0.3187
91629256|NCT04315298|183150872|SUPERIORITY|||||||0.0261|||||||Chi-squared|||Disease Severity: Critical||||0.0261
91629257|NCT04315298|183150872|SUPERIORITY|||||||0.9117|||||||Chi-squared|||Disease Severity: MSOD||||0.9117
91629258|NCT04315298|183150872|SUPERIORITY|||||||0.7584|||||||Chi-squared|||Disease Severity: MSOD||||0.7584
91629259|NCT04315298|183150876|SUPERIORITY||Hazard Ratio (HR)|0.32||||0.0385|TWO_SIDED|95.0|0.11|0.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.94|0.11|0.0385
91629260|NCT04315298|183150876|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0782|TWO_SIDED|95.0|0.14|1.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.05|0.14|0.0782
91629261|NCT04315298|183150876|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2436|TWO_SIDED|95.0|0.7|2.14||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.14|0.70|0.2436
91629262|NCT04315298|183150876|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3223|TWO_SIDED|95.0|0.46|1.51||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.51|0.46|0.3223
91629263|NCT04315298|183150876|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.467|TWO_SIDED|95.0|0.36|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.52|0.36|0.4670
91629264|NCT04315298|183150876|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3728|TWO_SIDED|95.0|0.35|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.47|0.35|0.3728
91629265|NCT04315298|183150882|SUPERIORITY||Risk Difference (RD)|2.7||||0.5851|TWO_SIDED|95.0|-7.0|12.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.4|-7.0|0.5851
91629266|NCT04315298|183150882|SUPERIORITY||Risk Difference (RD)|-2.6||||0.5767|TWO_SIDED|95.0|-11.7|6.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.5|-11.7|0.5767
91629267|NCT04315298|183150883|SUPERIORITY||Risk Difference (RD)|5.2||||0.4777|TWO_SIDED|95.0|-9.4|18.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.6|-9.4|0.4777
91629268|NCT04315298|183150883|SUPERIORITY||Risk Difference (RD)|5.7||||0.4202|TWO_SIDED|95.0|-8.4|18.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.2|-8.4|0.4202
91629269|NCT04315298|183150884|SUPERIORITY||Risk Difference (RD)|0.2||||0.9696|TWO_SIDED|95.0|-9.5|9.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||9.9|-9.5|0.9696
91629270|NCT04315298|183150884|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3152|TWO_SIDED|95.0|-13.8|4.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.4|-13.8|0.3152
91629271|NCT04315298|183150885|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3217|TWO_SIDED|95.0|-22.8|7.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.2|-22.8|0.3217
91629272|NCT04315298|183150885|SUPERIORITY||Risk Difference (RD)|-5.5||||0.463|TWO_SIDED|95.0|-20.2|8.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||8.7|-20.2|0.4630
91629273|NCT04315298|183150885|SUPERIORITY||Risk Difference (RD)|-13.3||||0.0971|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.0971
91629274|NCT04315298|183150885|SUPERIORITY||Risk Difference (RD)|-11.9||||0.1193|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.1193
91629275|NCT04315298|183150886|SUPERIORITY||Risk Difference (RD)|-0.6||||0.8844|TWO_SIDED|95.0|-9.3|7.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.7|-9.3|0.8844
91629276|NCT04315298|183150886|SUPERIORITY||Risk Difference (RD)|5.2||||0.2247|TWO_SIDED|95.0|-3.3|13.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||13.0|-3.3|0.2247
91629277|NCT04315298|183150886|SUPERIORITY||Risk Difference (RD)|-13.3||||0.2102|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.2102
91629278|NCT04315298|183150886|SUPERIORITY||Risk Difference (RD)|-11.9||||0.8292|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.8292
91629279|NCT04315298|183150887|SUPERIORITY||Risk Difference (RD)|9.8||||0.2203|TWO_SIDED|95.0|-6.0|24.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||24.3|-6.0|0.2203
91629280|NCT04315298|183150887|SUPERIORITY||Risk Difference (RD)|8.8||||0.2483|TWO_SIDED|95.0|-6.1|22.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||22.6|-6.1|0.2483
91629281|NCT04315298|183150888|SUPERIORITY||Risk Difference (RD)|4.1||||0.602|TWO_SIDED|95.0|-11.2|18.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.5|-11.2|0.6020
91664829|NCT00112437|183222892|SUPERIORITY_OR_OTHER||Difference in Least Square Means|7.24||||0.852||95.0|-5.73|20.21||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||20.21|-5.73|0.852
91629282|NCT04315298|183150888|SUPERIORITY||Risk Difference (RD)|5.9||||0.4342|TWO_SIDED|95.0|-8.9|19.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||19.5|-8.9|0.4342
91664830|NCT00112437|183222892|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.39||||||95.0|-13.69|12.92|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||12.92|-13.69|
91664831|NCT00112437|183222892|SUPERIORITY_OR_OTHER||Difference in Least Square Means|36.79||||||95.0|21.19|52.38|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||52.38|21.19|
91691991|NCT03380429|183278459|OTHER||Mean Difference (Final Values)|9.7||||0.004|TWO_SIDED|95.0|3.1|16.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.3|3.1|0.004
91629283|NCT04315298|183150889|SUPERIORITY||Risk Difference (RD)|5.2||||0.2896|TWO_SIDED|95.0|-4.3|14.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||14.7|-4.3|0.2896
91629284|NCT04315298|183150889|SUPERIORITY||Risk Difference (RD)|-2.9||||0.5355|TWO_SIDED|95.0|-11.8|6.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.2|-11.8|0.5355
91629285|NCT04315298|183150890|SUPERIORITY||Risk Difference (RD)|0.5||||0.921|TWO_SIDED|95.0|-9.2|10.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.2|-9.2|0.9210
91629286|NCT04315298|183150890|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3174|TWO_SIDED|95.0|-13.8|4.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.5|-13.8|0.3174
91629287|NCT04315298|183150891|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.0705|TWO_SIDED|95.0|0.98|2.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.66|0.98|0.0705
91629288|NCT04315298|183150891|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.18|TWO_SIDED|95.0|0.92|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.43|0.92|0.1800
91629289|NCT04315298|183150892|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.1831|TWO_SIDED|95.0|0.91|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.52|0.91|0.1831
91664832|NCT00112437|183222893|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.49||||0.011|TWO_SIDED|95.0|-39.55|-3.43||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||-3.43|-39.55|0.011
91664833|NCT00112437|183222893|SUPERIORITY_OR_OTHER||Difference in Least square means|13.31||||0.618||95.0|-7.1|33.71||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least square means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||33.71|-7.10|0.618
91629290|NCT04315298|183150892|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.877|TWO_SIDED|95.0|0.82|1.34||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.34|0.82|0.8770
91629291|NCT04315298|183150893|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7103|TWO_SIDED|95.0|0.35|2.06||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.06|0.35|0.7103
91629292|NCT04315298|183150894|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.1512|TWO_SIDED|95.0|0.89|2.43||P-value from stratified log-rank test|Log Rank|||||2.43|0.89|0.1512
91664834|NCT00112437|183222893|SUPERIORITY_OR_OTHER||Difference in Least square means|7.77|||||TWO_SIDED|95.0|-13.46|29.01|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||29.01|-13.46|
91664835|NCT00112437|183222893|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.23|||||TWO_SIDED|95.0|23.86|74.59|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||74.59|23.86|
91664836|NCT00112437|183222894|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.45|||||TWO_SIDED|95.0|3.38|9.53||||||In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.||9.53|3.38|
91664837|NCT00112437|183222895|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.31|||||TWO_SIDED|95.0|3.44|9.17||||||||9.17|3.44|
91664838|NCT00112437|183222896|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.71|||||TWO_SIDED|95.0|-0.16|5.57||||||||5.57|-0.16|
91664839|NCT00112437|183222897|SUPERIORITY_OR_OTHER||Difference in Least Square Means|8.13|||||TWO_SIDED|95.0|3.8|12.46||||||||12.46|3.80|
91664840|NCT00112437|183222898|SUPERIORITY_OR_OTHER||Difference in Least Square Means|1.46|||||TWO_SIDED|95.0|-1.54|4.46||||||||4.46|-1.54|
91664841|NCT00112437|183222899|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.47|||||TWO_SIDED|95.0|-0.93|5.88||||||||5.88|-0.93|
91664842|NCT00112437|183222900|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-78.06|||||TWO_SIDED|95.0|-119.2|-36.92||||||||-36.92|-119.20|
91664843|NCT00112437|183222901|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-34.25|||||TWO_SIDED|95.0|-78.7|10.2||||||||10.20|-78.70|
91664844|NCT00112437|183222902|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-39.25|||||TWO_SIDED|95.0|-87.17|8.68||||||||8.68|-87.17|
91664845|NCT00112437|183222903|SUPERIORITY_OR_OTHER||Difference in Least Square Means|16.59|||||TWO_SIDED|95.0|-5.67|38.85||||||||38.85|-5.67|
91629293|NCT04315298|183150894|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.2952|TWO_SIDED|95.0|0.85|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.85|0.2952
91629294|NCT04315298|183150895|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2297|TWO_SIDED|95.0|0.89|1.5||P-value from stratified log-rank test|Log Rank|||||1.50|0.89|0.2297
91629295|NCT04315298|183150895|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8651|TWO_SIDED|95.0|0.79|1.3||P-value from stratified log-rank test|Log Rank|||||1.30|0.79|0.8651
91629296|NCT04315298|183150896|SUPERIORITY||Risk Difference (RD)|-1.0||||0.8864|TWO_SIDED|95.0|-15.2|12.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.1|-15.2|0.8864
91629297|NCT04315298|183150896|SUPERIORITY||Risk Difference (RD)|-2.1||||0.75|TWO_SIDED|95.0|-15.8|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-15.8|0.7500
91629298|NCT04315298|183150897|SUPERIORITY||Risk Difference (RD)|-1.5||||0.6858|TWO_SIDED|95.0|-9.1|5.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||5.6|-9.1|0.6858
91664846|NCT00112437|183222904|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-5.43|||||TWO_SIDED|95.0|-42.04|31.18||||||||31.18|-42.04|
91714208|NCT02157519|183320215|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.72|0.01||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.01|-0.72|0.057
91664847|NCT00112437|183222905|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.1|||||TWO_SIDED|95.0|13.37|84.83||||||||84.83|13.37|
91664848|NCT00112437|183222906|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|209.44|||||TWO_SIDED|95.0|127.14|291.73||||||||291.73|127.14|
91664849|NCT03703258|183222923|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.26||0.6|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.60
91664850|NCT03703258|183222923|SUPERIORITY||Cohen's D|0.36|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
91664851|NCT03703258|183222924|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.27||0.94|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.94
91664852|NCT03703258|183222924|SUPERIORITY||Cohen's D|-0.01|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
91664853|NCT03703258|183222925|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.38|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.38
91714209|NCT02157519|183320215|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.72||0.178|TWO_SIDED|95.0|-2.39|0.45||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.45|-2.39|0.178
91714210|NCT02157519|183320215|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.481|TWO_SIDED|95.0|-0.35|0.75||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.75|-0.35|0.481
91664854|NCT03703258|183222925|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
91664855|NCT03703258|183222926|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.04
91664856|NCT03703258|183222926|SUPERIORITY||Cohen's D|-0.7|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
91664857|NCT03703258|183222927|SUPERIORITY||Slope|-1.23|STANDARD_ERROR_OF_MEAN|1.88||0.51|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.51
91664858|NCT03703258|183222927|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
91664859|NCT03703258|183222927|SUPERIORITY||Cohen's D|-0.1|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
91664860|NCT03703258|183222927|SUPERIORITY||Cohen's D|0.02|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
91664861|NCT03703258|183222928|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.04
91664862|NCT03703258|183222928|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.34
91664863|NCT03703258|183222928|SUPERIORITY||Cohen's D|0.92|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to post-intervention only||||
91664864|NCT03703258|183222928|SUPERIORITY||Cohen's D|0.68|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to 3 months||||
91664865|NCT03703258|183222929|SUPERIORITY||Slope|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.13
91714211|NCT02157519|183320215|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.97|TWO_SIDED|95.0|-0.34|0.35||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.35|-0.34|0.970
91714212|NCT02157519|183320216|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.682|TWO_SIDED|95.0|-0.15|0.1||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.10|-0.15|0.682
91714213|NCT02157519|183320217|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.64|TWO_SIDED|95.0|-0.24|0.15||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment||0.15|-0.24|0.640
91792095|NCT03036800|183461951|SUPERIORITY||Mean Difference (Net)|-5.37|||<|0.001|TWO_SIDED|95.0|-7.02|-3.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.71|-7.02|<0.001
91482835|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.3061|TWO_SIDED|95.0|-3.04|0.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.97|-3.04|0.3061
91527807|NCT01678820|182930639|SUPERIORITY_OR_OTHER||Difference in percents|12.3|||||TWO_SIDED|95.0|0.7|24.0|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple imputations.|||24.0|0.7|
91629299|NCT04315298|183150897|SUPERIORITY||Risk Difference (RD)|0.4||||0.9173|TWO_SIDED|95.0|-7.0|7.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||7.0|-7.0|0.9173
91629300|NCT04315298|183150898|SUPERIORITY||Risk Difference (RD)|4.5||||0.5239|TWO_SIDED|95.0|-9.7|17.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||17.3|-9.7|0.5239
91629301|NCT04315298|183150898|SUPERIORITY||Risk Difference (RD)|3.7||||0.5809|TWO_SIDED|95.0|-10.0|15.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||15.6|-10.0|0.5809
91629302|NCT04315298|183150899|SUPERIORITY||Risk Difference (RD)|0.4||||0.9343|TWO_SIDED|95.0|-9.3|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-9.3|0.9343
91629303|NCT04315298|183150899|SUPERIORITY||Risk Difference (RD)|-5.0||||0.2822|TWO_SIDED|95.0|-14.1|4.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.1|-14.1|0.2822
91629304|NCT04315298|183150900|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.4519|TWO_SIDED|95.0|0.75|2.18||P-value from stratified log-rank test|Log Rank|||||2.18|0.75|0.4519
91629305|NCT04315298|183150900|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.2818|TWO_SIDED|95.0|0.81|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.81|0.2818
91629306|NCT04315298|183150901|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4674|TWO_SIDED|95.0|0.84|1.43||P-value from stratified log-rank test|Log Rank|||||1.43|0.84|0.4674
91629307|NCT04315298|183150901|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.8503|TWO_SIDED|95.0|0.77|1.28||P-value from stratified log-rank test.|Log Rank|||||1.28|0.77|0.8503
91629308|NCT04315298|183150902|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.6156|TWO_SIDED|95.0|0.31|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.31|0.6156
91629309|NCT04315298|183150903|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0843|TWO_SIDED|95.0|0.41|1.03||P-value from stratified log-rank test|Log Rank|||||1.03|0.41|0.0843
91629310|NCT04315298|183150903|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1576|TWO_SIDED|95.0|0.44|1.07||P-value from stratified log-rank test|Log Rank|||||1.07|0.44|0.1576
91629311|NCT04315298|183150904|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.198|TWO_SIDED|95.0|0.57|1.14||P-value from stratified log-rank test|Log Rank|||||1.14|0.57|0.1980
91629312|NCT04315298|183150904|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7973|TWO_SIDED|95.0|0.73|1.36||P-value from stratified log-rank test.|Log Rank|||||1.36|0.73|0.7973
91629313|NCT04315298|183150905|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.5023|TWO_SIDED|95.0|0.13|2.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.75|0.13|0.5023
91629314|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2804|TWO_SIDED|95.0|-0.2|0.8||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.8|-0.2|0.2804
91629315|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5023|TWO_SIDED|95.0|-0.5|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.3|-0.5|0.5023
91629316|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3821|TWO_SIDED|95.0|-0.7|1.9||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.9|-0.7|0.3821
91629317|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.9737|TWO_SIDED|95.0|-1.2|1.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.1|-1.2|0.9737
91664866|NCT03703258|183222929|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.64||0.24|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.24
91792096|NCT03036800|183461952|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|95.0|-6.42|-1.77|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.77|-6.42|0.001
91664867|NCT03703258|183222929|SUPERIORITY||Cohen's D|-0.41|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
91664868|NCT03703258|183222929|SUPERIORITY||Cohen's D|-0.23|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
91664869|NCT03703258|183222930|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.25||0.85|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.85
91664870|NCT03703258|183222930|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.25||0.96|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.96
91664871|NCT03703258|183222930|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
91664872|NCT03703258|183222930|SUPERIORITY||Cohen's D|0.003|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
91482836|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||0.3082|TWO_SIDED|95.0|-2.61|0.84||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.84|-2.61|0.3082
91664873|NCT03703258|183222931|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.75|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.75
91664874|NCT03703258|183222931|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
91664875|NCT03703258|183222931|SUPERIORITY||Cohen's D|-0.12|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
91664876|NCT03703258|183222931|SUPERIORITY||Cohen's D|-0.16|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
91664877|NCT03703258|183222932|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.35||0.86|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.86
91664878|NCT03703258|183222932|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.36||0.55|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.55
91664879|NCT03703258|183222932|SUPERIORITY||Cohen's D|-0.04|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
91691992|NCT03380429|183278459|OTHER||Mean Difference (Final Values)|7.1||||0.032|TWO_SIDED|95.0|0.6|13.5||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.5|0.6|0.032
91691993|NCT03380429|183278459|OTHER||Mean Difference (Final Values)|5.9||||0.07|TWO_SIDED|95.0|-0.5|12.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||12.4|-0.5|0.070
91691994|NCT03380429|183278459|OTHER||Mean Difference (Final Values)|3.4||||0.294|TWO_SIDED|95.0|-3.0|9.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||9.9|-3.0|0.294
91691995|NCT03380429|183278460|OTHER||Mean Difference (Final Values)|4.8||||0.118|TWO_SIDED|95.0|-1.2|10.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.8|-1.2|0.118
91629318|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|1.15||0.3179|TWO_SIDED|95.0|-1.1|3.4||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||3.4|-1.1|0.3179
91629319|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|1.03||0.6302|TWO_SIDED|95.0|-1.5|2.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.5|-1.5|0.6302
91629320|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|1.64||0.2862|TWO_SIDED|95.0|-1.5|5.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||5.0|-1.5|0.2862
91629321|NCT04315298|183150906|SUPERIORITY||Risk Difference (RD)|1.1|STANDARD_ERROR_OF_MEAN|1.49||0.4509|TWO_SIDED|95.0|-1.8|4.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||4.1|-1.8|0.4509
91629322|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.564|TWO_SIDED|95.0|-0.8|0.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.5|-0.8|0.5640
91629323|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1602|TWO_SIDED|95.0|-1.0|0.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.2|-1.0|0.1602
91629324|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.9144|TWO_SIDED|95.0|-1.3|1.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.2|-1.3|0.9144
91629325|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|0.61||0.145|TWO_SIDED|95.0|-2.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||0.3|-2.1|0.1450
91629326|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8378|TWO_SIDED|95.0|-1.7|2.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.1|-1.7|0.8378
91629327|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|0.89||0.1988|TWO_SIDED|95.0|-2.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||0.6|-2.9|0.1988
91482837|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.2672|TWO_SIDED|95.0|-3.09|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-3.09|0.2672
91482838|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.11||||0.0427|TWO_SIDED|95.0|-4.15|-0.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.07|-4.15|0.0427
91629328|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|1.26||0.8556|TWO_SIDED|95.0|-2.2|2.7||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||2.7|-2.2|0.8556
91629329|NCT04315298|183150907|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|1.19||0.263|TWO_SIDED|95.0|-3.7|1.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||1.0|-3.7|0.2630
91629330|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3662|TWO_SIDED|95.0|-0.2|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.5|-0.2|0.3662
91629331|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.16||0.082|TWO_SIDED|95.0|0.0|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.6|0.0|0.0820
91629332|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.6984|TWO_SIDED|95.0|-0.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.9|0.6984
91629333|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9833|TWO_SIDED|95.0|-0.6|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.6|0.9833
91629334|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1436|TWO_SIDED|95.0|-0.3|2.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||2.0|-0.3|0.1436
91629335|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.419|TWO_SIDED|95.0|-0.6|1.4||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.4|-0.6|0.4190
91629336|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.652|TWO_SIDED|95.0|-0.7|1.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||1.2|-0.7|0.6520
91629337|NCT04315298|183150908|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.801|TWO_SIDED|95.0|-1.1|0.9||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.9|-1.1|0.8010
91629338|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3724|TWO_SIDED|95.0|-0.4|0.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.2|-0.4|0.3724
91629339|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.7034|TWO_SIDED|95.0|-0.2|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.3|-0.2|0.7034
91629340|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5841|TWO_SIDED|95.0|-0.4|0.7||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.7|-0.4|0.5841
91629341|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6648|TWO_SIDED|95.0|-0.4|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.4|0.6648
91629342|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4624|TWO_SIDED|95.0|-0.4|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.4|0.4624
91629343|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2546|TWO_SIDED|95.0|-0.3|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.3|0.2546
91629344|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5312|TWO_SIDED|95.0|-1.0|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.5|-1.0|0.5312
91629345|NCT04315298|183150909|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.3039|TWO_SIDED|95.0|-1.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.3|-1.1|0.3039
91629346|NCT03267511|183150938|OTHER||Difference of Least Mean Square|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|||"The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.~The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives."|0.31|-0.19|0.6499
91629347|NCT03267511|183150938|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|-0.33 to 0.18|||0.18|-0.33|0.5680
91629348|NCT03267511|183150939|OTHER||Difference of Least Square mean|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.31|-0.19|0.6499
91629349|NCT03267511|183150940|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.18|-0.33|0.5680
91664880|NCT03703258|183222932|SUPERIORITY||Cohen's D|-0.39|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
91664881|NCT01125163|183222933|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0||||All infants were analyzed according to their assigned groups.|Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.59
91691996|NCT03380429|183278460|OTHER||Mean Difference (Final Values)|4.8||||0.105|TWO_SIDED|95.0|-1.0|10.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.7|-1.0|0.105
91629350|NCT03050307|183150955|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-3.7|||||TWO_SIDED|95.0|-10.966|3.339||||||||3.339|-10.966|
91629351|NCT03050307|183150956|NON_INFERIORITY|If the primary outcome measure was met, then the hypothesis for this outcome measure was that if the lower bound of the 95% CI of the difference was ≥-10%, noninferiority for TAK-438 relative to lansoprazole with regard to H pylori eradication was declared.|Exact (Clopper-Pearson)|7.2|||||TWO_SIDED|95.0|-4.469|18.825||||||||18.825|-4.469|
91629352|NCT03050307|183150957|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-6.0|||||TWO_SIDED|95.0|-16.644|4.741||||||||4.741|-16.644|
91629353|NCT03050307|183150958|OTHER|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-1.1|||||TWO_SIDED|95.0|-25.175|23.07||||||Epigastric Pain (Postprandial)||23.070|-25.175|
91629354|NCT03050307|183150958|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|4.5|||||TWO_SIDED|95.0|-11.907|20.931||||||Epigastric Pain (Fasting/Nocturnal)||20.931|-11.907|
91629355|NCT03050307|183150958|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|16.0|||||TWO_SIDED|95.0|-11.255|43.321||||||Abdominal Bloating||43.321|-11.255|
91629356|NCT03050307|183150958|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|10.1|||||TWO_SIDED|95.0|-5.109|25.348||||||Heartburn||25.348|-5.109|
91629357|NCT03050307|183150958|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-12.2|||||TWO_SIDED|95.0|-45.138|20.694||||||Lack of Appetite||20.694|-45.138|
91629358|NCT01250899|183150964|SUPERIORITY_OR_OTHER||Percentage of 12-wk 25(OH)D ≥30ng/mL|70.0|||<|0.05|TWO_SIDED|95.0|60.0|80.0|||Exact binomial||The primary endpoint (mean change in 25(OH)D following 12 weeks of vitamin D repletion in vitamin D insufficient subjects) was dichotomized to success or failure to achieve a week twelve 25(OH)D level ≥30ng/mL.|We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).||80|60|<0.05
91691997|NCT03380429|183278460|OTHER||Mean Difference (Final Values)|9.2||||0.002|TWO_SIDED|95.0|3.3|15.1||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||15.1|3.3|0.002
91664882|NCT01125163|183222934|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.64
91629359|NCT01536418|183150971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||||TWO_SIDED|95.0|-3.0|19.3||||||||19.3|-3.0|
91629360|NCT01536418|183150972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-5.8|10.8||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 8||10.8|-5.8|
91629361|NCT01536418|183150972|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.6|||||TWO_SIDED|95.0|-3.0|14.3||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 12||14.3|-3.0|
91629362|NCT01536418|183150972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-4.6|9.5||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at both Weeks 8 and 12||9.5|-4.6|
91629363|NCT01536418|183150973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-6.0|15.9||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at Week 8||15.9|-6.0|
91629364|NCT01536418|183150973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-1.0|18.7||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at both Week 8 and Week 12||18.7|-1.0|
91629365|NCT02498392|183150999|SUPERIORITY||Difference of Least Square (LS) Means|-0.2|STANDARD_ERROR_OF_MEAN|1.04|=|0.416|TWO_SIDED|60.0|-1.1|0.66|||Mixed-effects Model for Repeated Measure|||||0.66|-1.10|= 0.416
91629366|NCT02498392|183151000|SUPERIORITY||Difference of Least Square (LS) Means|0.3|STANDARD_ERROR_OF_MEAN|0.88|=|0.647|TWO_SIDED|60.0|-0.41|1.07||1-sided|Mixed-effects Model for Repeated Measure|||||1.07|-0.41|= 0.647
91629367|NCT02473289|183151024|SUPERIORITY||Difference of Least Square (LS) Means|-0.8|STANDARD_ERROR_OF_MEAN|1.67||0.31|TWO_SIDED|75.0|-2.77|1.1||1-sided|MMRM|Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.||||1.10|-2.77|0.310
91629368|NCT03285490|183151047|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
91629369|NCT03285490|183151048|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%.|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
91629370|NCT00068822|183151059|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.49|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||2.8|-1.3|0.49
91629371|NCT00068822|183151060|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.45|TWO_SIDED|95.0|-1.7|3.7|||ANCOVA|||SF-36 Physical Component Summary treatment effect||3.7|-1.7|0.45
91629372|NCT00068822|183151060|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.83|TWO_SIDED|95.0|-3.7|4.6|||ANCOVA|||SF-36 Mental Component Summary treatment effect||4.6|-3.7|0.83
91629373|NCT00068822|183151060|SUPERIORITY_OR_OTHER||Treatment Effect|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Frequency Index treatment effect||0.6|-0.2|0.33
91629374|NCT00068822|183151060|SUPERIORITY_OR_OTHER||Treatment Effect|0.33||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Bothersome Index treatment effect||0.6|-0.2|0.33
91629375|NCT00068822|183151060|SUPERIORITY_OR_OTHER||Treatment Effect|0.05||||0.13|TWO_SIDED|95.0|-0.01|0.11|||ANCOVA|||EQ-5D Index treatment effect||0.11|-0.01|0.13
91629376|NCT00068822|183151060|SUPERIORITY_OR_OTHER||Treatment Effect|0.4||||0.5|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||SOF-ADL treatment effect||1.6|-0.8|0.5
91629377|NCT00068822|183151061|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.19|TWO_SIDED|95.0|-0.3|1.7|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||1.7|-0.3|0.19
91629378|NCT00424099|183151062|OTHER|||||||0.16|||||||Kruskal-Wallis|||||||0.16
91629379|NCT00424099|183151063|OTHER|||||||0.45|||||||Kruskal-Wallis|||||||0.45
91629380|NCT03689972|183151064|SUPERIORITY||Ratio of Mean|4.24|||=|0.0755|TWO_SIDED|95.0|0.86|20.85|||Negative Binomial Regression|The model included treatment as classification variable \& baseline body weight, duration of natalizumab exposure at baseline, \& region as covariates.||||20.85|0.86|=0.0755
91629381|NCT03689972|183151065|SUPERIORITY||Percentage|87.8|||||TWO_SIDED|95.0|80.68|93.01|||Exact Binomial method|Percentage of participants preferring natalizumab SC at end of crossover period of Part 2, and 95% CI was calculated using the exact binomial method.||||93.01|80.68|
91629382|NCT03689972|183151067|SUPERIORITY||Ratio of annualized relapse rate|1.32481|||=|0.6312|TWO_SIDED|95.0|0.42016|4.17725|||Poisson Regression|Poisson regression model was adjusted for baseline body weight, duration of natalizumab exposure at baseline, and region.||||4.17725|0.42016|=0.6312
91629383|NCT03689972|183151073|SUPERIORITY||Difference|0.47|||=|0.764|TWO_SIDED|95.0|-2.61|3.54||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||3.54|-2.61|=0.764
91629384|NCT03689972|183151080|SUPERIORITY||Difference|0.08|||=|0.357|TWO_SIDED|95.0|-0.09|0.25||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||0.25|-0.09|=0.357
91629385|NCT00435929|183151088|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.656|||||TWO_SIDED|90.0|0.268|1.603||||||Comparison between normal liver function and moderate hepatic impairment for SQV||1.603|0.268|
91629386|NCT00435929|183151088|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.764|||||TWO_SIDED|90.0|0.505|1.156||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.156|0.505|
91664883|NCT02463487|183222956|OTHER|||||||0.87|||||||t-test, 1 sided|||||||0.87
91482839|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0716|TWO_SIDED|95.0|-3.37|0.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.15|-3.37|0.0716
91664884|NCT02463487|183222958|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
91664885|NCT01120028|183222959|OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.64|||Log Rank|||||0.64|0.28|<0.0001
91664886|NCT01120028|183222960|OTHER|||||||0.5|||||||ANCOVA|||||||0.5
91664887|NCT01120028|183222961|OTHER||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.59|2.55|||Regression, Cox|||||2.55|0.59|0.58
91664888|NCT01120028|183222962|OTHER||Rate Ratio|1.99||||0.23|TWO_SIDED|95.0|0.64|6.18|||Log Rank|||||6.18|0.64|0.23
91664889|NCT01120028|183222963|OTHER||Rate Ratio|1.02||||0.88|TWO_SIDED|95.0|0.8|1.29|||Regression, Cox|||||1.29|0.80|0.88
91482840|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.7184|TWO_SIDED|95.0|-2.09|3.0||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.00|-2.09|0.7184
91482841|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.7004|TWO_SIDED|95.0|-2.06|3.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.03|-2.06|0.7004
91629387|NCT00435929|183151089|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.311|1.644||||||Comparison between normal liver function and moderate hepatic impairment for SQV.||1.644|0.311|
91664890|NCT01120028|183222964|OTHER||Rate ratio|1.51||||0.008|TWO_SIDED|95.0|1.11|2.06|||Log Rank|||||2.06|1.11|0.008
91664891|NCT01120028|183222965|OTHER||Rate Ratio|1.0||||0.99|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.99
91629388|NCT00435929|183151089|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.844|||||TWO_SIDED|90.0|0.551|1.292||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.292|0.551|
91629389|NCT02417064|183151103|SUPERIORITY||Difference of Least Square (LS) Means|-3.2||||0.088|TWO_SIDED|95.0|-6.88|0.45|||Mixed Model for Repeated Measures|||||0.45|-6.88|0.088
91629390|NCT02417064|183151103|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.67|-0.49||||||||-0.49|-7.67|
91629391|NCT02417064|183151104|SUPERIORITY||Difference of Least Square (LS) Means|-2.0|||=|0.25|TWO_SIDED|95.0|-5.52|1.42|||ANCOVA|||||1.42|-5.52|= 0.250
91629392|NCT02417064|183151104|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.53|-0.6||||||||-0.6|-7.53|
91629393|NCT02437162|183151119|SUPERIORITY||Percentage difference|2.586||||0.669|TWO_SIDED|95.0|-9.138|14.31|||Cochran-Mantel-Haenszel|||||14.310|-9.138|0.669
91629394|NCT02437162|183151119|SUPERIORITY||Percentage difference|-0.646||||0.913|TWO_SIDED|95.0|-12.18|10.887|||Cochran-Mantel-Haenszel|||||10.887|-12.180|0.913
91629395|NCT04338321|183151181|SUPERIORITY||Mean Difference (Final Values)|9.44|||=|0.003|TWO_SIDED|95.0|3.19|15.68|||Cochran-Mantel-Haenszel|||||15.68|3.19|=0.003
91629396|NCT03321526|183151206|SUPERIORITY|||||||0.5355|TWO_SIDED||||||Log Rank|||||||0.5355
91629397|NCT03097133|183151244|SUPERIORITY||Difference of Least Square Means|-3.9|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.6|-1.11|||ANCOVA|||||-1.11|-6.60|0.006
91629398|NCT00371540|183151267|SUPERIORITY_OR_OTHER|||||||0.65|||||||Fisher Exact|||Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.||||0.65
91629399|NCT00371540|183151268|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91629400|NCT00371540|183151269|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
91629401|NCT01989572|183151270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|||||||Log Rank|stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.||||||0.528
91629402|NCT01989572|183151271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Log Rank|stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions||||||0.131
91629403|NCT01989572|183151272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Log Rank|stratifying on GM-CSF, site of metastases and number of metastatic lesions||||||0.60
91629404|NCT01989572|183151273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||stratifying on GM-CSF, site of metastases and number of metastatic lesions|Log Rank|||||||0.71
91629405|NCT01989572|183151274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.88
91629406|NCT01989572|183151274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with negative HLA-A2 status||||0.69
91664892|NCT01120028|183222966|OTHER||Rate Ratio|0.76||||0.52|TWO_SIDED|95.0|0.34|1.73|||Log Rank|||||1.73|0.34|0.52
91664893|NCT04633564|183223003|EQUIVALENCE|The equivalence region is (0.73, 1.36).|Risk Ratio (RR)|0.96|||||TWO_SIDED|90.0|0.83|1.12||||||||1.12|0.83|
91629407|NCT01989572|183151275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.91
91629408|NCT01989572|183151275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparisons in patients with negative HLA-A2 status||||0.13
91629409|NCT00262639|183151276|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||||||0.03
91629410|NCT00262639|183151277|SUPERIORITY|||||||0.0006||||||This p value is for the interaction of AW status by medication group.|ANOVA|||The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.||||0.0006
91629411|NCT04159701|183151280|SUPERIORITY||Mean Difference (Final Values)|2.94||||0.38|TWO_SIDED|95.0|-3.73|9.6|||Mixed Models Analysis|||||9.60|-3.73|0.380
91629412|NCT04159701|183151281|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.415|TWO_SIDED|95.0|-1.89|4.5|||Mixed Models Analysis|||||4.50|-1.89|0.415
91629413|NCT04159701|183151282|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.369|TWO_SIDED|95.0|-2.09|5.53|||Mixed Models Analysis|||||5.53|-2.09|0.369
91629414|NCT04159701|183151283|SUPERIORITY||Odds Ratio (OR)|0.61||||0.674|TWO_SIDED|95.0|0.14|2.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< 28 vs \>= 28) score.||||2.70|0.14|0.674
91629415|NCT04159701|183151284|SUPERIORITY||Odds Ratio (OR)|0.59||||0.674|TWO_SIDED|95.0|0.13|2.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< median vs \>= median) score.||||2.68|0.13|0.674
91664894|NCT04198363|183223005|NON_INFERIORITY|Noninferiority of vonoprazan to esomeprazole was evaluated by Farrington and Manning test using a noninferiority margin of 10% for analysis.|Difference in Proportions|0.1|||=|0.0009|TWO_SIDED|95.0|-5.95|6.17|||Farrington and Manning Test||Difference in proportions for vonoprazan versus esomeprazole was analyzed and the 2-sided Wald confidence interval was used for determining the 95% confidence interval.|||6.17|-5.95|=0.0009
91664895|NCT03442322|183223016|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.25||||0.492|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.492
91664896|NCT03442322|183223017|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.73||||0.765|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.765
91664897|NCT03442322|183223018|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.77||||0.808|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.808
91792097|NCT03036800|183461953|SUPERIORITY||Mean Difference (Net)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.5|-1.91|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.91|-3.5|<0.001
91629416|NCT03605836|183151287|SUPERIORITY||Least Squares (LS) Mean Difference|-4.01|||=|0.0021|TWO_SIDED|95.0|-6.55|-1.46|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.46|-6.55|=0.0021
91629417|NCT03605836|183151287|SUPERIORITY||LS Mean Difference|-4.42|||=|0.0009|TWO_SIDED|95.0|-7.02|-1.82|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.82|-7.02|=0.0009
91629418|NCT03605836|183151288|SUPERIORITY||LS Mean Difference|-0.33|||=|0.0073|TWO_SIDED|95.0|-0.57|-0.09|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.09|-0.57|=0.0073
91629419|NCT03605836|183151288|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0245|TWO_SIDED|95.0|-0.53|-0.04|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.04|-0.53|=0.0245
91629420|NCT01933399|183151298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||0.01|TWO_SIDED|95.0|2.2|16.6|||ANCOVA||"Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline.~a priori threshold determined to be .05. no adjustments for multiple comparisons."|ANCOVA Adjusted for baseline score||16.6|2.2|.01
91629421|NCT01933399|183151298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.16|TWO_SIDED|95.0|-2.0|12.6||a priori threshold determined to be .05. no adjustments for multiple comparisons.|ANCOVA|Adjustment for baseline.||||12.6|-2.0|.16
91629422|NCT01933399|183151299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.01|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|||Adjusted for baseline.||-0.4|-2.3|0.01
91629423|NCT01933399|183151299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.05|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||Adjusted for baseline.||0|-2.1|.05
91629424|NCT00633360|183151309|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||.59
91629425|NCT00633360|183151310|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||.29
91629426|NCT03241589|183151313|SUPERIORITY||Odds Ratio (OR)|0.931||||0.7428|TWO_SIDED|95.0|0.606|1.429|||Regression, Logistic||Referent group is Urban|We followed power calculations described in uploaded protocol document, using an incomplete design matrix with a 3-month transition period, a level of precision α=0.05 and a minimum power level of 0.80. We also assumed a total number of clusters I=36 as per the study design and the number of baseline measurements B=2. Due to insufficient sample size, we modified groups studied.||1.429|0.606|0.7428
91629427|NCT03241589|183151314|SUPERIORITY||Odds Ratio (OR)|2.258||||0.0031|TWO_SIDED|95.0|1.181|4.315|||Regression, Logistic|2 degrees of freedom, Wald Chi-Square 11.5759|Veterans with expired requests = referent.|||4.315|1.181|0.0031
91792098|NCT03036800|183461954|SUPERIORITY||Mean Difference (Net)|-1.89|||<|0.001|TWO_SIDED|95.0|-2.91|-0.86|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.86|-2.91|<0.001
91714214|NCT01656395|183320218|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.685|TWO_SIDED|95.0|-0.084|0.127|||cLDA model|||Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.127|-0.084|0.685
91714215|NCT01656395|183320218|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.477|TWO_SIDED|95.0|-0.149|0.07|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.07|-0.149|0.477
91714216|NCT01656395|183320218|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.733|TWO_SIDED|95.0|-0.092|0.13|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.13|-0.092|0.733
91714217|NCT01656395|183320218|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.89|TWO_SIDED|95.0|-0.115|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.115|0.89
91714218|NCT01656395|183320218|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.935|TWO_SIDED|95.0|-0.109|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.109|0.935
91714219|NCT01656395|183320221|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.169|TWO_SIDED|95.0|-17.48|3.08|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||3.08|-17.48|0.169
91714220|NCT01656395|183320221|SUPERIORITY||Mean Difference (Final Values)|-9.092||||0.092|TWO_SIDED|95.0|-19.67|1.485|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.485|-19.67|0.092
91714221|NCT01656395|183320221|SUPERIORITY||Mean Difference (Final Values)|-9.469||||0.083|TWO_SIDED|95.0|-20.19|1.25|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.25|-20.19|0.083
91714222|NCT01656395|183320221|SUPERIORITY||Mean Difference (Final Values)|-4.666||||0.367|TWO_SIDED|95.0|-14.83|5.501|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||5.501|-14.83|0.367
91714223|NCT01656395|183320221|SUPERIORITY||Mean Difference (Final Values)|-5.247||||0.308|TWO_SIDED|95.0|-15.36|4.871|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||4.871|-15.36|0.308
91714224|NCT01656395|183320222|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.429|TWO_SIDED|95.0|-0.427|0.182|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.182|-0.427|0.429
91714225|NCT01656395|183320222|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.37|TWO_SIDED|95.0|-0.169|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.169|0.370
91714226|NCT01656395|183320222|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.579|TWO_SIDED|95.0|-0.402|0.225|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.225|-0.402|0.579
91714227|NCT01656395|183320222|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.305|TWO_SIDED|95.0|-0.142|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.142|0.305
91714228|NCT01656395|183320222|SUPERIORITY||Mean Difference (Final Values)|-0.136||||0.372|TWO_SIDED|95.0|-0.434|0.163|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.163|-0.434|0.372
91525561|NCT05096208|182926324|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.905|1.261|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.261|0.905|
91482842|NCT01227564|182839159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.6723|TWO_SIDED|95.0|-1.77|2.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.71|-1.77|0.6723
91629428|NCT03011775|183151339|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was P value of .05||||||<0.05
91629429|NCT03011775|183151340|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
91629430|NCT03011775|183151342|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
91629431|NCT03011775|183151343|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91629432|NCT03011775|183151345|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91629433|NCT03011775|183151346|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91629434|NCT03011775|183151347|SUPERIORITY||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||||||=0.3
91629435|NCT03748420|183151351|SUPERIORITY||Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.09845||0.0103|TWO_SIDED|95.0|1.06|1.56|||Regression, Logistic|||||1.56|1.06|0.0103
91629436|NCT03748420|183151352|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.1166||0.7967|TWO_SIDED|95.0|0.82|1.3|||Regression, Logistic|||||1.30|0.82|0.7967
91629437|NCT03748420|183151353|SUPERIORITY||Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.08906||0.0589|TWO_SIDED|95.0|0.99|1.41|||Regression, Logistic|||||1.41|0.99|0.0589
91714229|NCT01656395|183320223|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.114|TWO_SIDED|95.0|-1.184|0.128|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.128|-1.184|0.114
91525562|NCT05096208|182926324|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.953|1.336|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.336|0.953|
91629438|NCT03748420|183151354|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.0871||0.21|TWO_SIDED|95.0|-0.8|3.5|||Mixed Models Analysis|||||3.5|-0.8|0.21
91629439|NCT03748420|183151355|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1234||0.2|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.20
91629440|NCT03748420|183151356|SUPERIORITY||Mean Difference (Net)|-7.47|STANDARD_ERROR_OF_MEAN|59.96||0.901|TWO_SIDED|95.0|-124.99|110.04|||Mixed Models Analysis|||||110.04|-124.99|0.901
91629441|NCT01690988|183151380|OTHER|Test of independence|Difference in Percentages|0.36|STANDARD_ERROR_OF_MEAN|3.301||0.912|TWO_SIDED|95.0|-6.07|7.38|||Chi-squared||Difference in delirium incidence between placebo control and combined ketamine groups.|The primary analysis was a comparison between the placebo control group and the combined ketamine groups||7.38|-6.07|0.912
91629442|NCT01690988|183151381|SUPERIORITY|||||||0.964|||||||ANOVA|one-way||We compared the combined average pain level (pain level at rest, taking a deep breath, and/or when moving) over the entire day (AM and PM).||||0.964
91629443|NCT01690988|183151382|SUPERIORITY|||||||0.476|||||||ANOVA|||"All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~\* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"||||0.476
91629444|NCT01690988|183151383|SUPERIORITY||frequency-test|0.572||||0.572|TWO_SIDED||||||Chi-squared|||"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM \& PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3"||||0.572
91629445|NCT01690988|183151385|SUPERIORITY|||||||0.01|||||||Chi-squared|||Frequency of patients reporting hallucinations using the DSAQ instrument.||||0.01
91629446|NCT01690988|183151386|SUPERIORITY|||||||0.03||||||"Patients where asked whether Following their surgery they had bad dreams or nightmares the response choices: Yes/No question The incidence of hallucination and nightmares were assessed separately and compared across the three study group."|Chi-squared|||||||0.03
91629447|NCT01634100|183151410|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|135.2|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|129.58|141.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||141.06|129.58|
91629448|NCT01634100|183151410|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.47|STANDARD_DEVIATION|7.4|||TWO_SIDED|90.0|146.41|160.88|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||160.88|146.41|
91629449|NCT01634100|183151411|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|175.14|STANDARD_DEVIATION|15.4|||TWO_SIDED|90.0|160.14|191.56|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||191.56|160.14|
91629450|NCT01634100|183151411|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|125.6|STANDARD_DEVIATION|15.9|||TWO_SIDED|90.0|113.67|138.78|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||138.78|113.67|
91629451|NCT01634100|183151412|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|136.42|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|130.61|142.48|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||142.48|130.61|
91629452|NCT01634100|183151412|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.61|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|146.5|161.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||161.06|146.50|
91629453|NCT01594411|183151465|SUPERIORITY_OR_OTHER||||||<|0.001|||||||one-sided binomial with alpha level of 0|||"The proportion of patients whose final treatment plan changes from the preliminary will be estimated, and a one-sided binomial test with alpha level of .05 will be used to test whether it is greater than 10%.~This is the level at which it is assumed that patient management has been modified by a practically important amount."||||<0.001
91629454|NCT00924729|183151466|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91629455|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|54.2|||||TWO_SIDED|95.0|-41.7|150.1||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 5||150.1|-41.7|
91629456|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|-52.0|||||TWO_SIDED|95.0|-148.5|44.5||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 5||44.5|-148.5|
91664898|NCT03442322|183223019|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.86||||0.108|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.108
91664899|NCT03442322|183223020|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|2.59||||0.411|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.411
91482843|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9535|TWO_SIDED|95.0|-1.58|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.68|-1.58|0.9535
91482844|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9914|TWO_SIDED|95.0|-1.63|1.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.65|-1.63|0.9914
91629457|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|5.5|||||TWO_SIDED|95.0|-96.0|106.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 5||106.9|-96.0|
91629458|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|33.5|||||TWO_SIDED|95.0|-66.8|133.9||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 5||133.9|-66.8|
91629459|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|99.8|||||TWO_SIDED|95.0|-2.4|202.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 5||202.0|-2.4|
91629460|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|37.8|||||TWO_SIDED|95.0|-107.1|182.6||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 10||182.6|-107.1|
91629461|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|-72.0|||||TWO_SIDED|95.0|-215.7|71.8||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 10||71.8|-215.7|
91629462|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|-72.3|||||TWO_SIDED|95.0|-241.5|96.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 10||96.9|-241.5|
91629463|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|-17.9|||||TWO_SIDED|95.0|-154.9|119.2||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 10||119.2|-154.9|
91629464|NCT01332097|183151471|SUPERIORITY||Least squares mean difference|123.6|||||TWO_SIDED|95.0|-15.8|263.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 10||263.0|-15.8|
91629465|NCT03209362|183151473|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.5453|TWO_SIDED|95.0|-12.4|6.6|||ANCOVA|||||6.6|-12.4|0.5453
91629466|NCT03209362|183151474|SUPERIORITY||Least Squares Mean Difference|-3.5||||0.5386|TWO_SIDED|95.0|-14.9|7.8|||Longitudinal model|||Week 12||7.8|-14.9|0.5386
91629467|NCT03209362|183151474|SUPERIORITY||Least Squares Mean Difference|-3.3||||0.5873|TWO_SIDED|95.0|-15.2|8.6|||Longitudinal model|||Week 26||8.6|-15.2|0.5873
91629468|NCT03209362|183151475|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.6347|TWO_SIDED|95.0|-15.0|9.2|||Longitudinal model|||Week 12||9.2|-15.0|0.6347
91629469|NCT03209362|183151475|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.7806|TWO_SIDED|95.0|-14.3|10.8|||Longitudinal model|||Week 26||10.8|-14.3|0.7806
91629470|NCT03209362|183151476|SUPERIORITY||Least Squares Mean Difference|-0.9||||0.8819|TWO_SIDED|95.0|-13.2|11.4|||Longitudinal model|||Week 12||11.4|-13.2|0.8819
91629471|NCT03209362|183151476|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.3796|TWO_SIDED|95.0|-18.3|7.1|||Longitudinal model|||Week 26||7.1|-18.3|0.3796
91629472|NCT03209362|183151477|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.6217|TWO_SIDED|95.0|-14.9|9.0|||Longitudinal model|||Week 12||9.0|-14.9|0.6217
91629473|NCT03209362|183151477|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.6901|TWO_SIDED|95.0|-14.8|9.8|||Longitudinal model|||Week 26||9.8|-14.8|0.6901
91629474|NCT01628042|183151478|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.83|||||TWO_SIDED|90.0|1.36|2.46|||ANCOVA|||||2.46|1.36|
91629475|NCT01628042|183151478|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|2.06|||||TWO_SIDED|90.0|1.55|2.74|||ANCOVA|||||2.74|1.55|
91629476|NCT01628042|183151478|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.49|||||TWO_SIDED|90.0|1.11|2.0|||ANCOVA|||||2.00|1.11|
91629477|NCT01628042|183151479|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.42|||||TWO_SIDED|90.0|0.89|2.27|||ANCOVA|||||2.27|0.89|
91629478|NCT01628042|183151479|SUPERIORITY_OR_OTHER||Geometric least-squares mean ration|1.68|||||TWO_SIDED|90.0|1.07|2.63|||ANCOVA|||||2.63|1.07|
91629479|NCT01628042|183151479|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.96|||||TWO_SIDED|90.0|1.23|3.13|||ANCOVA|||||3.13|1.23|
91629480|NCT01628042|183151480|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|90.0|0.41|0.74|||ANCOVA|||||0.74|0.41|
91629481|NCT01628042|183151480|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.49|||||TWO_SIDED|90.0|0.36|0.65|||ANCOVA|||||0.65|0.36|
91629482|NCT01628042|183151480|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|90.0|0.5|0.9|||ANCOVA|||||0.90|0.50|
91629483|NCT04852666|183151487|SUPERIORITY|||||||0.751|||||||t-test, 2 sided|||||||0.751
91629484|NCT04852666|183151487|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
91629485|NCT04852666|183151488|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
91629486|NCT04852666|183151488|SUPERIORITY|||||||0.357|||||||t-test, 2 sided|||||||0.357
91629487|NCT04852666|183151489|SUPERIORITY|||||||0.012|||||||Chi-squared|||||||0.012
91629488|NCT04852666|183151489|SUPERIORITY|||||||0.956|||||||Chi-squared|||||||0.956
91629489|NCT04852666|183151490|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.103
91629490|NCT04852666|183151490|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
91629491|NCT04852666|183151491|SUPERIORITY|||||||0.785|||||||t-test, 2 sided|||||||0.785
91629492|NCT04852666|183151492|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
91629493|NCT04852666|183151493|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||||||0.887
91629494|NCT04852666|183151493|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
91629495|NCT05426460|183151494|SUPERIORITY|||||||0.438|||||||ANOVA|||2 x 2 ANOVA||||.438
91629496|NCT05426460|183151495|SUPERIORITY|||||||0.847|||||||ANOVA|||2 x 2 ANOVA||||.847
91629497|NCT05426460|183151496|SUPERIORITY|||||||0.57|||||||ANOVA|||2 X 2 ANOVA||||.570
91629498|NCT05426460|183151497|SUPERIORITY|||||||0.657|||||||ANOVA|||2 x 2 ANOVA||||.657
91629499|NCT05426460|183151498|SUPERIORITY|||||||0.254|||||||ANOVA|||2 x 2 ANOVA||||.254
91629500|NCT05426460|183151499|SUPERIORITY|||||||0.852|||||||ANOVA|||2 x 2 ANOVA with Main effect p-values for tDCS and AAT reported in comments below||||.852
91629501|NCT05426460|183151500|SUPERIORITY|||||||0.732|||||||ANOVA|||2 x 2 ANOVA||||.732
91629502|NCT05426460|183151501|SUPERIORITY|||||||0.038|||||||ANOVA|||2 x 2 ANOVA||||.038
91629503|NCT05426460|183151502|SUPERIORITY|||||||0.029|||||||ANOVA|||2 x 2 ANOVA||||.029
91629504|NCT05426460|183151503|SUPERIORITY|||||||0.353|||||||ANOVA|||2 x 2 ANOVA||||.353
91629505|NCT01405027|183151513|SUPERIORITY_OR_OTHER|||||||0.4864|TWO_SIDED||||||ANOVA|||||||0.4864
91629506|NCT01193049|183151518|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.25||||0.001|TWO_SIDED|90.0|0.14|0.46||1-sided p-value, α = 0.05|ANOVA|||GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.46|0.14|0.001
91629507|NCT01193049|183151518|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.2|||<|0.001|TWO_SIDED|90.0|0.13|0.3||1-sided p value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.||0.30|0.13|<0.001
91629508|NCT01193049|183151518|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|0.2||||0.553||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.||||0.553
91629509|NCT01193049|183151518|SUPERIORITY_OR_OTHER||Correlation FR from Placebo :SP vs NE|-0.02||||0.964||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.||||0.964
91629510|NCT01193049|183151519|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.27||||0.009|TWO_SIDED|90.0|0.12|0.62||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.62|0.12|0.009
91629511|NCT01193049|183151519|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.31|||<|0.001|TWO_SIDED|90.0|0.22|0.43||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.||0.43|0.22|<0.001
91629512|NCT01193049|183151519|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|-0.02||||0.962||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.||||0.962
91629513|NCT01193049|183151519|SUPERIORITY_OR_OTHER||Correlation FR from Placebo: SP vs NE|0.07||||0.83||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.||||0.83
91629514|NCT01193049|183151520|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.8||||0.258|TWO_SIDED|90.0|0.43|1.47||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.47|0.43|0.258
91629515|NCT01193049|183151520|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|1.08||||0.681|TWO_SIDED|90.0|0.8|1.46||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||1.46|0.80|0.681
91629516|NCT01193049|183151521|SUPERIORITY_OR_OTHER||GM FR from Placebo:SP|0.61||||0.117|TWO_SIDED|90.0|0.3|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.24|0.30|0.117
91629517|NCT01193049|183151521|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.64||||0.011|TWO_SIDED|90.0|0.47|0.86||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||0.86|0.47|0.011
91629518|NCT01193049|183151523|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-5|1.51||||0.01|TWO_SIDED|90.0|1.15|1.99||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.||1.99|1.15|0.010
91664900|NCT03442322|183223021|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.08||||0.981|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.981
91664901|NCT03442322|183223022|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.51||||0.02|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.020
91664902|NCT03442322|183223023|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.62||||0.299|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.299
91664903|NCT03442322|183223024|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.68||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.389
91664904|NCT03442322|183223025|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.14||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.389
91664905|NCT03442322|183223026|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-5.95||||0.043|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.043
91664906|NCT03442322|183223027|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.91||||0.279|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.279
91664907|NCT03442322|183223028|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.92||||0.728|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.728
91664908|NCT03442322|183223029|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.75||||0.49|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.490
91482845|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9682|TWO_SIDED|95.0|-1.39|1.44||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.44|-1.39|0.9682
91525563|NCT05096208|182926324|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.884|1.262|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.262|0.884|
91664909|NCT03442322|183223030|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|4.44||||0.232|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.232
91664910|NCT03442322|183223031|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.11||||0.708|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.708
91664911|NCT03442322|183223032|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.0||||0.775|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.775
91664912|NCT03442322|183223033|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.77||||0.584|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.584
91664913|NCT03442322|183223034|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.25||||0.898|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.898
91664914|NCT03442322|183223035|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.79||||0.217|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.217
91525564|NCT03518658|182926342|SUPERIORITY||Mean Difference (Final Values)|34.7|||<|0.001|TWO_SIDED|95.0|32.4|37.0||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||37.0|32.4|<0.001
91629519|NCT01193049|183151523|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-13|1.35||||0.02|TWO_SIDED|90.0|1.07|1.71||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.||1.71|1.07|0.020
91629520|NCT01193049|183151524|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.82||||0.119|TWO_SIDED|90.0|0.62|1.09||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.||1.09|0.62|0.119
91629521|NCT01193049|183151524|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.68||||0.103|TWO_SIDED|90.0|0.41|1.14||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.||1.14|0.41|0.103
91629522|NCT01193049|183151525|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.6||||0.003|TWO_SIDED|90.0|0.46|0.77||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.||0.77|0.46|0.003
91629523|NCT01193049|183151525|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.49||||0.036|TWO_SIDED|90.0|0.26|0.93||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.||0.93|0.26|0.036
91629524|NCT01193049|183151526|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.7||||0.143|TWO_SIDED|90.0|0.4|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.||1.24|0.40|0.143
91629525|NCT01193049|183151526|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.61||||0.056|TWO_SIDED|90.0|0.37|1.02||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.||1.02|0.37|0.056
91629526|NCT05085327|183151531|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Original: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
91629527|NCT05085327|183151531|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Mint: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
91629528|NCT05085327|183151531|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Black Cherry: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
91664915|NCT03442322|183223036|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.39||||0.56|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.560
91664916|NCT03442322|183223037|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.08||||0.277|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.277
91629529|NCT02234050|183151540|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.204|TWO_SIDED|80.0|0.997|2.028|||Regression, Cox|||||2.028|0.997|0.204
91629530|NCT02234050|183151543|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.94|TWO_SIDED|95.0|0.53|1.71|||Regression, Cox|||||1.71|0.53|0.94
91629531|NCT00592176|183151545|SUPERIORITY_OR_OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
91629532|NCT00981292|183151567|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||A Bonferroni adjustment was made for multiplicity.|ANOVA|||This data was analysed by two-way repeated measures ANOVA (task \[epoch\] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.||||<0.05
91629533|NCT00981292|183151568|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.||||>0.05
91629534|NCT00981292|183151569|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Mood data was analysed via student t-test.||||>0.05
91629535|NCT02280096|183151592|SUPERIORITY||t-boostrap|0.028||||0.028|TWO_SIDED||||||t-test, 1 sided|||||||0.028
91629536|NCT02280096|183151593|SUPERIORITY||t-boostrap|0.001||||0.001|ONE_SIDED||||||t-test, 1 sided|||||||0.001
91629537|NCT02280096|183151594|SUPERIORITY||t-boostrap|0.016||||0.016|TWO_SIDED||||||t-test, 1 sided|||||||0.016
91664917|NCT03442322|183223038|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.53||||0.4|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.400
91525565|NCT03518658|182926342|SUPERIORITY||Mean Difference (Final Values)|38.3|||<|0.001|TWO_SIDED|95.0|34.8|41.9||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||41.9|34.8|<0.001
91629538|NCT02280096|183151595|SUPERIORITY||t-boostrap|0.64||||0.64|ONE_SIDED||||||t-test, 1 sided|||Reading speed||||0.64
91629539|NCT02280096|183151595|SUPERIORITY||t-boostrap|0.43||||0.43|TWO_SIDED||||||t-test, 1 sided|||Count speed||||0.43
91629540|NCT02280096|183151595|SUPERIORITY||t-boostrap|0.9||||0.9|TWO_SIDED||||||t-test, 1 sided|||Alternation||||0.9
91629541|NCT02280096|183151596|SUPERIORITY||t-boostrap|0.83||||0.83|TWO_SIDED||||||t-test, 1 sided|||||||0.83
91629542|NCT02280096|183151597|SUPERIORITY||t-boostrap|0.92||||0.92|ONE_SIDED||||||t-test, 1 sided|||||||0.92
91629543|NCT02280096|183151598|SUPERIORITY||t-boostrap|0.017||||0.017|TWO_SIDED||||||t-test, 1 sided|||Total moves||||0.017
91629544|NCT02280096|183151598|SUPERIORITY||t-boostrap|0.01||||0.01|TWO_SIDED||||||t-test, 1 sided|||Correct moves||||0.010
91629545|NCT02280096|183151599|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Execution time||||0.001
91629546|NCT02280096|183151599|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Problem-solving time||||0.001
91629547|NCT03733132|183151606|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
91629548|NCT03733132|183151607|SUPERIORITY|||||||0.389|||||||t-test, 2 sided|||||||0.389
91629549|NCT03733132|183151608|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
91629550|NCT03733132|183151609|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
91629551|NCT03733132|183151610|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
91629552|NCT02219516|183151620|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|153.0|||||TWO_SIDED|90.0|115.0|203.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||203|115|
91629553|NCT02219516|183151620|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|173.0|||||TWO_SIDED|90.0|131.0|230.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||230|131|
91629554|NCT02219516|183151620|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|228.0|||||TWO_SIDED|90.0|155.0|336.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||336|155|
91629555|NCT02219516|183151622|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|131.0|||||TWO_SIDED|90.0|98.6|174.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||174|98.6|
91629556|NCT02219516|183151622|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|222.0|||||TWO_SIDED|90.0|171.0|287.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||287|171|
91629557|NCT02219516|183151622|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|211.0|||||TWO_SIDED|90.0|139.0|319.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||319|139|
91664918|NCT03442322|183223039|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.18||||0.303|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.303
91629558|NCT02219516|183151623|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|124.0|||||TWO_SIDED|90.0|88.8|173.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||173|88.8|
91629559|NCT02219516|183151623|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|248.0|||||TWO_SIDED|90.0|168.0|366.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||366|168|
91629560|NCT02219516|183151623|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|230.0|||||TWO_SIDED|90.0|146.0|363.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||363|146|
91629561|NCT02219516|183151625|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|76.0|||||TWO_SIDED|90.0|57.1|101.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||101|57.1|
91629562|NCT02219516|183151625|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|45.1|||||TWO_SIDED|90.0|34.9|58.3|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||58.3|34.9|
91629563|NCT02219516|183151625|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|47.8|||||TWO_SIDED|90.0|31.5|72.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||72.5|31.5|
91629564|NCT02219516|183151626|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|80.8|||||TWO_SIDED|90.0|57.9|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|57.9|
91664919|NCT00521586|183223045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|2.8|||||TWO_SIDED|95.0|-1.8|7.4||||||A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang||7.4|-1.8|
91629565|NCT02219516|183151626|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|40.3|||||TWO_SIDED|90.0|27.3|59.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||59.5|27.3|
91629566|NCT02219516|183151626|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|43.5|||||TWO_SIDED|90.0|27.5|68.7|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||68.7|27.5|
91629567|NCT02219516|183151627|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.4|||||TWO_SIDED|90.0|60.6|150.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||150|60.6|
91664920|NCT00521586|183223045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|1.6|||||TWO_SIDED|95.0|-3.9|7.2||||||A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||7.2|-3.9|
91664921|NCT00521586|183223045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|0.3|||||TWO_SIDED|95.0|-5.6|6.2||||||B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||6.2|-5.6|
91664922|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.74|||||TWO_SIDED|95.0|0.58|0.95||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.58|
91664923|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.66|
91664924|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.69|||||TWO_SIDED|95.0|0.55|0.87||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.87|0.55|
91664925|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.67|1.05||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.05|0.67|
91664926|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.70|
91664927|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.75|||||TWO_SIDED|95.0|0.6|0.93||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.60|
91714230|NCT01656395|183320223|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.827|TWO_SIDED|95.0|-0.75|0.6|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.6|-0.75|0.827
91482846|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2008|TWO_SIDED|95.0|-2.96|0.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.64|-2.96|0.2008
91664928|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.63|0.95||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.63|
91664929|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.86|0.59|
91664930|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.6|0.98||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.98|0.60|
91664931|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.88||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.88|0.58|
91714231|NCT01656395|183320223|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.75|TWO_SIDED|95.0|-0.789|0.569|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.569|-0.789|0.75
91629568|NCT02219516|183151627|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|58.3|||||TWO_SIDED|90.0|30.2|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|30.2|
91629569|NCT02219516|183151627|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|21.2|||||TWO_SIDED|90.0|13.6|32.8|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||32.8|13.6|
91629570|NCT01872897|183151628|SUPERIORITY||Mean Difference (Final Values)|-9.79||||0.0003|TWO_SIDED|95.0|-14.85|-4.74|||Mixed Models Analysis|||||-4.74|-14.85|0.0003
91629571|NCT01872897|183151629|SUPERIORITY||Mean Difference (Final Values)|-15.76|||<|0.0001|TWO_SIDED|95.0|-22.82|-8.71|||Mixed Models Analysis|||||-8.71|-22.82|<0.0001
91629572|NCT01872897|183151630|SUPERIORITY||Median Difference (Final Values)|-19.4||||0.0004|TWO_SIDED|95.0|-29.6|-9.2|||Mixed Models Analysis|||||-9.2|-29.6|0.0004
91629573|NCT01872897|183151631|SUPERIORITY||Mean Difference (Final Values)|-16.3||||0.0019|TWO_SIDED|95.0|-26.2|-6.4|||Mixed Models Analysis|||||-6.4|-26.2|0.0019
91629574|NCT01872897|183151632|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.029|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||||-0.1|-1.6|0.0290
91629575|NCT01872897|183151633|SUPERIORITY||Mean Difference (Final Values)|-14.4|||<|0.0001|TWO_SIDED|95.0|-20.57|-8.23|||Mixed Models Analysis|||||-8.23|-20.57|<0.0001
91629576|NCT01872897|183151634|SUPERIORITY||Mean Difference (Final Values)|-23.37|||<|0.0001|TWO_SIDED|95.0|-31.55|-15.19|||Mixed Models Analysis|||||-15.19|-31.55|<0.0001
91664932|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.74|
91664933|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.67|1.1||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.10|0.67|
91792099|NCT03036800|183461955|SUPERIORITY||Mean Difference (Net)|-3.28||||0.01|TWO_SIDED|95.0|-5.77|-0.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.80|-5.77|0.01
91629577|NCT01872897|183151635|SUPERIORITY||Mean Difference (Final Values)|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.6|||Mixed Models Analysis|||||-4.6|-10.0|<0.0001
91629578|NCT01872897|183151636|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0001|TWO_SIDED|95.0|-9.4|-3.3|||Mixed Models Analysis|||||-3.3|-9.4|0.0001
91629579|NCT01872897|183151637|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0075|TWO_SIDED|95.0|-10.9|-1.8|||Mixed Models Analysis|||||-1.8|-10.9|0.0075
91629580|NCT01872897|183151638|SUPERIORITY||Mean Difference (Final Values)|-24.145||||0.0007|TWO_SIDED|95.0|-37.432|-10.858|||Mixed Models Analysis|||||-10.858|-37.432|0.0007
91691998|NCT03380429|183278460|OTHER||Mean Difference (Final Values)|7.3||||0.015|TWO_SIDED|95.0|1.5|13.2||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||13.2|1.5|0.015
91629581|NCT04254796|183151639|OTHER|Calculation of the effect size (Cohen's d)|Cohen's d|0.27|||||TWO_SIDED|95.0|-0.13|0.68||||||The goal of the analysis was to measure the effect size of the change in the primary mechanistic outcome (Putamen structural node strength), with a Go/No-Go threshold of Cohen's d \> 0.20.||0.68|-0.13|
91629582|NCT02845440|183151641|SUPERIORITY||Odds Ratio (OR)|2.4||||0.013|TWO_SIDED|95.0|1.2|4.79||A priori threshold for significance was p \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.79|1.20|0.013
91629583|NCT02845440|183151641|SUPERIORITY||Odds Ratio (OR)|1.31||||0.481|TWO_SIDED|95.0|0.62|2.74||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.74|0.62|0.481
91629584|NCT02845440|183151641|SUPERIORITY||Odds Ratio (OR)|1.84||||0.036|TWO_SIDED|95.0|1.04|3.24||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||3.24|1.04|0.036
91629585|NCT02845440|183151642|SUPERIORITY||Odds Ratio (OR)|1.35||||0.174|TWO_SIDED|95.0|0.88|2.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||2.06|0.88|0.174
91629586|NCT02845440|183151642|SUPERIORITY||Odds Ratio (OR)|0.69||||0.092|TWO_SIDED|95.0|0.45|1.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.06|0.45|0.092
91664934|NCT00521586|183223046|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.66|
91664935|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.34||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.34|0.83|
91664936|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.75|1.08||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.75|
91792100|NCT03036800|183461956|SUPERIORITY||Mean Difference (Net)|-5.51||||0.003|TWO_SIDED|95.0|-9.09|-1.94|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.94|-9.09|0.003
91792101|NCT03036800|183461976|SUPERIORITY||Odds Ratio (OR)|10.53|||<|0.001|TWO_SIDED|95.0|3.83|28.97|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||28.97|3.83|<0.001
91629587|NCT02845440|183151643|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.61|4.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||4.75|1.61|<0.001
91629588|NCT02845440|183151643|SUPERIORITY||Odds Ratio (OR)|0.9||||0.742|TWO_SIDED|95.0|0.5|1.64||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.64|0.50|0.742
91629589|NCT02845440|183151644|SUPERIORITY||Odds Ratio (OR)|1.57||||0.056|TWO_SIDED|95.0|0.99|2.51||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the AD+CHW intervention was 2.8%.|2.51|0.99|0.056
91629590|NCT02845440|183151645|SUPERIORITY||Odds Ratio (OR)|1.97||||0.012|TWO_SIDED|95.0|1.16|3.33||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as varenicline use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the AD+CHW intervention was 13.9%.|3.33|1.16|0.012
91629591|NCT02845440|183151646|SUPERIORITY||Odds Ratio (OR)|1.71||||0.032|TWO_SIDED|95.0|1.05|2.79||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.79|1.05|0.032
91664937|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.28|0.92|
91664938|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.08||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.68|
91525566|NCT00649389|182926344|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91664939|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.88|1.3||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.30|0.88|
91792102|NCT03036800|183461977|SUPERIORITY||Odds Ratio (OR)|23.1|||<|0.001|TWO_SIDED|95.0|7.55|70.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||70.67|7.55|<0.001
91792103|NCT03036800|183461980|SUPERIORITY||Odds Ratio (OR)|7.71|||<|0.001|TWO_SIDED|95.0|2.75|21.6|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||21.60|2.75|<0.001
91664940|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.21||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.84|
91664941|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.06||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.78|
91664942|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.48||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.48|0.93|
91664943|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.17||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.17|0.86|
91664944|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.27||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.84|
91664945|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.87|
91664946|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.85|1.31||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.31|0.85|
91482847|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7988|TWO_SIDED|95.0|-2.07|1.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.60|-2.07|0.7988
91629592|NCT02845440|183151646|SUPERIORITY||Odds Ratio (OR)|1.37||||0.376|TWO_SIDED|95.0|0.68|2.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.75|0.68|0.376
91629593|NCT02845440|183151646|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.3||||0.645|TWO_SIDED|95.0|0.42|4.05|||Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.05|0.42|0.645
91629594|NCT02845440|183151647|SUPERIORITY||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.34|2.56||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|The CHW intervention increased odds of self-reported use of any TUD medication by 1.85.||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||2.56|1.34|<0.001
91629595|NCT02845440|183151647|SUPERIORITY||Odds Ratio (OR)|0.7||||0.084|TWO_SIDED|95.0|0.46|1.05|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.05|0.46|0.084
91629596|NCT02845440|183151647|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.22||||0.589|TWO_SIDED|95.0|0.59|2.55|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.55|0.59|0.589
91664947|NCT00521586|183223047|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.27||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.80|
91664948|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.18|0.87|
91664949|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.10|0.82|
91629597|NCT02845440|183151648|SUPERIORITY||Odds Ratio (OR)|3.05|||<|0.001|TWO_SIDED|95.0|1.99|4.68||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||4.68|1.99|<0.001
91664950|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.88|
91664951|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.80|
91714232|NCT01656395|183320223|SUPERIORITY||Mean Difference (Final Values)|0.275||||0.403|TWO_SIDED|95.0|-0.371|0.921|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.921|-0.371|0.403
91714233|NCT01656395|183320223|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.237|TWO_SIDED|95.0|-1.035|0.257|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.257|-1.035|0.237
91714234|NCT01656395|183320224|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.565|TWO_SIDED|95.0|-1.066|0.583|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.583|-1.066|0.565
91714235|NCT01656395|183320224|SUPERIORITY||Mean Difference (Final Values)|0.135||||0.754|TWO_SIDED|95.0|-0.713|0.983|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.983|-0.713|0.754
91792104|NCT03036800|183461981|SUPERIORITY||Odds Ratio (OR)|6.14||||0.032|TWO_SIDED|95.0|1.16|32.32|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||32.32|1.16|0.032
91482848|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.3764|TWO_SIDED|95.0|-2.27|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.87|-2.27|0.3764
91482849|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.4177|TWO_SIDED|95.0|-2.98|1.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.25|-2.98|0.4177
91482850|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.6494|TWO_SIDED|95.0|-2.67|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.68|-2.67|0.6494
91714236|NCT01656395|183320224|SUPERIORITY||cLDA model|-0.251||||0.563|TWO_SIDED|95.0|-1.104|0.603|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.603|-1.104|0.563
91792105|NCT03036800|183461982|SUPERIORITY||Odds Ratio (OR)|11.48|||<|0.001|TWO_SIDED|95.0|3.8|34.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||34.67|3.80|<0.001
91714237|NCT01656395|183320224|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.559|TWO_SIDED|95.0|-1.053|0.571|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.571|-1.053|0.559
91792106|NCT03036800|183461984|SUPERIORITY||Odds Ratio (OR)|13.63||||0.003|TWO_SIDED|95.0|2.47|75.09|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||75.09|2.47|0.003
91629598|NCT02845440|183151648|SUPERIORITY||Odds Ratio (OR)|0.89||||0.698|TWO_SIDED|95.0|0.51|1.57||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.57|0.51|0.698
91629599|NCT02845440|183151648|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.1||||0.845|TWO_SIDED|95.0|0.43|2.78|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.78|0.43|0.845
91629600|NCT02845440|183151649|SUPERIORITY||Odds Ratio (OR)|1.42||||0.158|TWO_SIDED|95.0|0.92|2.2||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the CHW intervention was 55.6%.|2.20|0.92|0.158
91629601|NCT02845440|183151650|SUPERIORITY||Odds Ratio (OR)|1.89||||0.013|TWO_SIDED|95.0|1.14|3.13||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as varenicline use and a clinic-varying random intercept. Regression coefficients and mediation analysis estimates were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the CHW intervention was 36.6%.|3.13|1.14|0.013
91629602|NCT02845440|183151651|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.505|TWO_SIDED|95.0|-0.16|0.33|||Regression, Linear|||The model had a clinic varying random intercept. This statistical model included cohort 1: TAU , AD, and AD+CHW||0.33|-0.16|0.505
91629603|NCT02845440|183151651|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.848|TWO_SIDED|95.0|-0.22|0.27||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.27|-0.22|0.848
91629604|NCT02845440|183151651|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.13|0.25||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.25|-0.13|0.529
91629605|NCT02845440|183151652|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.937|TWO_SIDED|95.0|-0.16|0.18|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.18|-0.16|0.937
91664952|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.22||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.22|0.84|
91664953|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
91664954|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.85|
91664955|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.07|0.81|
91664956|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.11||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.81|
91664957|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.06||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.79|
91664958|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.80|
91664959|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
91664960|NCT00521586|183223056|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.09||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.74|
91664961|NCT00828321|183223094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.16||||||90.0|85.08|104.21|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.21|85.08|
91664962|NCT00828321|183223095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.21|108.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.6|96.21|
91664963|NCT00828321|183223096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.34|108.58|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.58|96.34|
91664964|NCT00828321|183223097|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.52||||||90.0|92.63|104.79|||||This analysis was for informational purposes and was not used to establish bioequivalence.|||104.79|92.63|
91664965|NCT00828321|183223098|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.45||||||90.0|94.66|100.32|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.32|94.66|
91664966|NCT01592240|183223110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.28|||<|0.001|TWO_SIDED|95.0|-45.06|-23.5|||Mixed models repeated measures analysis|||||-23.50|-45.06|<0.001
91792107|NCT03036800|183461985|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of maintenance of weight loss of ≥15% at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
91629606|NCT02845440|183151652|SUPERIORITY||Median Difference (Final Values)|0.05||||0.683|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.29|-0.19|0.683
91664967|NCT01592240|183223110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-45.07|||<|0.001|TWO_SIDED|95.0|-55.93|-34.21|||Mixed models repeated measures analysis|||||-34.21|-55.93|<0.001
91664968|NCT01592240|183223110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.42|||<|0.001|TWO_SIDED|95.0|-64.14|-42.7|||Mixed models repeated measures analysis|||||-42.70|-64.14|<0.001
91664969|NCT01592240|183223110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.58|||<|0.001|TWO_SIDED|95.0|-40.49|-14.67|||Mixed models repeated measures analysis|||||-14.67|-40.49|<0.001
91664970|NCT01592240|183223110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-44.85|||<|0.001|TWO_SIDED|95.0|-57.65|-32.05|||Mixed models repeated measures analysis|||||-32.05|-57.65|<0.001
91664971|NCT01592240|183223111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.41|||<|0.001|TWO_SIDED|95.0|-39.15|-17.67|||Mixed models repeated measures analysis|||||-17.67|-39.15|<0.001
91482851|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.4674|TWO_SIDED|95.0|-2.54|1.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.18|-2.54|0.4674
91664972|NCT01592240|183223111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-43.21|||<|0.001|TWO_SIDED|95.0|-53.9|-32.51|||Mixed models repeated measures analysis|||||-32.51|-53.90|<0.001
91664973|NCT01592240|183223111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.03|||<|0.001|TWO_SIDED|95.0|-51.66|-30.41|||Mixed models repeated measures analysis|||||-30.41|-51.66|<0.001
91664974|NCT01592240|183223111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.77|||<|0.001|TWO_SIDED|95.0|-33.7|-13.84|||Mixed models repeated measures analysis|||||-13.84|-33.70|<0.001
91525567|NCT00649389|182926344|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91664975|NCT01592240|183223111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.36|||<|0.001|TWO_SIDED|95.0|-40.24|-20.49|||Mixed models repeated measures analysis|||||-20.49|-40.24|<0.001
91664976|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.0|||<|0.001|TWO_SIDED|95.0|-44.91|-25.1|||Mixed models repeated measures analysis|||Week 12||-25.10|-44.91|<0.001
91664977|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-42.32|||<|0.001|TWO_SIDED|95.0|-52.3|-32.33|||Mixed models repeated measures analysis|||Week 12||-32.33|-52.30|<0.001
91664978|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.12|||<|0.001|TWO_SIDED|95.0|-62.97|-43.27|||Mixed models repeated measures analysis|||Week 12||-43.27|-62.97|<0.001
91664979|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-26.96|||<|0.001|TWO_SIDED|95.0|-38.25|-15.67|||Mixed models repeated measures analysis|||Week 12||-15.67|-38.25|<0.001
91664980|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.13|||<|0.001|TWO_SIDED|95.0|-52.32|-29.94|||Mixed models repeated measures analysis|||Week 12||-29.94|-52.32|<0.001
91664981|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.09|||<|0.001|TWO_SIDED|95.0|-38.42|-19.77|||Mixed models repeated measures analysis|||Week 24||-19.77|-38.42|<0.001
91664982|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-40.14|||<|0.001|TWO_SIDED|95.0|-49.43|-30.86|||Mixed models repeated measures analysis|||Week 24||-30.86|-49.43|<0.001
91664983|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-39.16|||<|0.001|TWO_SIDED|95.0|-48.37|-29.94|||Mixed models repeated measures analysis|||Week 24||-29.94|-48.37|<0.001
91664984|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.79|||<|0.001|TWO_SIDED|95.0|-32.88|-14.7|||Mixed models repeated measures analysis|||Week 24||-14.70|-32.88|<0.001
91664985|NCT01592240|183223112|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.08|||<|0.001|TWO_SIDED|95.0|-38.13|-20.04|||Mixed models repeated measures analysis|||Week 24||-20.04|-38.13|<0.001
91664986|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.64||||0.281|TWO_SIDED|95.0|-1.35|4.63|||Mixed models repeated measures analysis|||Week 12||4.63|-1.35|0.281
91525568|NCT00649389|182926344|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91525569|NCT00649389|182926345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
91664987|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.73||||0.251|TWO_SIDED|95.0|-1.24|4.71|||Mixed models repeated measures analysis|||Week 12||4.71|-1.24|0.251
91792108|NCT03036800|183461986|SUPERIORITY||Mean Difference (Net)|-6.55|||<|0.001|TWO_SIDED|95.0|-7.81|-5.29|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.29|-7.81|<0.001
91664988|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.53||||0.724|TWO_SIDED|95.0|-2.43|3.5|||Mixed models repeated measures analysis|||Week 12||3.50|-2.43|0.724
91664989|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.45||||0.007|TWO_SIDED|95.0|1.21|7.7|||Mixed models repeated measures analysis|||Week 12||7.70|1.21|0.007
91664990|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.86||||0.019|TWO_SIDED|95.0|0.63|7.09|||Mixed models repeated measures analysis|||Week 12||7.09|0.63|0.019
91664991|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.72||||0.225|TWO_SIDED|95.0|-1.07|4.51|||Mixed models repeated measures analysis|||Week 24||4.51|-1.07|0.225
91664992|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.79||||0.571|TWO_SIDED|95.0|-1.97|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.97|0.571
91664993|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.49||||0.725|TWO_SIDED|95.0|-2.25|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-2.25|0.725
91664994|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.268|TWO_SIDED|95.0|-1.56|5.57|||Mixed models repeated measures analysis|||Week 24||5.57|-1.56|0.268
91664995|NCT01592240|183223113|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.996|TWO_SIDED|95.0|-3.55|3.54|||Mixed models repeated measures analysis|||Week 24||3.54|-3.55|0.996
91664996|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.41||||0.246|TWO_SIDED|95.0|-2.38|9.21|||Mixed models repeated measures analysis|||Week 12||9.21|-2.38|0.246
91664997|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.62||||0.371|TWO_SIDED|95.0|-3.14|8.38|||Mixed models repeated measures analysis|||Week 12||8.38|-3.14|0.371
91664998|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.35||||0.643|TWO_SIDED|95.0|-4.4|7.1|||Mixed models repeated measures analysis|||Week 12||7.10|-4.40|0.643
91664999|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.66||||0.018|TWO_SIDED|95.0|1.33|13.99|||Mixed models repeated measures analysis|||Week 12||13.99|1.33|0.018
91665000|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.52||||0.043|TWO_SIDED|95.0|0.22|12.83|||Mixed models repeated measures analysis|||Week 12||12.83|0.22|0.043
91665001|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.16|TWO_SIDED|95.0|-1.56|9.36|||Mixed models repeated measures analysis|||Week 24||9.36|-1.56|0.160
91665002|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.85||||0.758|TWO_SIDED|95.0|-4.56|6.25|||Mixed models repeated measures analysis|||Week 24||6.25|-4.56|0.758
91665003|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.57||||0.347|TWO_SIDED|95.0|-2.81|7.95|||Mixed models repeated measures analysis|||Week 24||7.95|-2.81|0.347
91665004|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.99||||0.343|TWO_SIDED|95.0|-3.22|9.21|||Mixed models repeated measures analysis|||Week 24||9.21|-3.22|0.343
91665005|NCT01592240|183223114|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7||||0.824|TWO_SIDED|95.0|-6.87|5.48|||Mixed models repeated measures analysis|||Week 24||5.48|-6.87|0.824
91665006|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.55|||<|0.001|TWO_SIDED|95.0|-25.44|-11.67|||Mixed models repeated measures analysis|||Week 12||-11.67|-25.44|<0.001
91665007|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.67|||<|0.001|TWO_SIDED|95.0|-34.55|-20.79|||Mixed models repeated measures analysis|||Week 12||-20.79|-34.55|<0.001
91665008|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.09|||<|0.001|TWO_SIDED|95.0|-38.95|-25.22|||Mixed models repeated measures analysis|||Week 12||-25.22|-38.95|<0.001
91629607|NCT02845440|183151652|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Mean Difference (Final Values)|0.3||||0.19|TWO_SIDED|95.0|-0.15|0.74|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.74|-0.15|0.190
91714238|NCT01656395|183320224|SUPERIORITY||Mean Difference (Final Values)|-0.071||||0.863|TWO_SIDED|95.0|-0.883|0.741|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.741|-0.883|0.863
91629608|NCT01849562|183151653|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|50.0|||||TWO_SIDED|95.0|1.8|82.7||||||Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||82.7|1.8|
91629609|NCT01849562|183151653|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|70.0|||||TWO_SIDED|95.0|24.2|93.6||||||Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||93.6|24.2|
91629610|NCT04599972|183151661|SUPERIORITY||Odds Ratio (OR)|2.979|||<|0.01|TWO_SIDED|95.0|1.753|5.064|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.064|1.753|<0.01
91629611|NCT04599972|183151662|SUPERIORITY||Odds Ratio (OR)|2.807|||<|0.01|TWO_SIDED|95.0|1.655|4.762|||Regression, Logistic|||||4.762|1.655|<0.01
91629612|NCT04599972|183151663|SUPERIORITY||Odds Ratio (OR)|6.002|||<|0.01|TWO_SIDED|95.0|3.431|10.499|||Regression, Logistic|||||10.499|3.431|<0.01
91629613|NCT04599972|183151664|SUPERIORITY||Odds Ratio (OR)|4.161|||<|0.01|TWO_SIDED|95.0|2.404|7.204|||Regression, Logistic|||||7.204|2.404|<0.01
91629614|NCT02069704|183151665|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|99.4|||||TWO_SIDED|90.0|90.5|109.0|||||For the ratio: BEVZ92 represents the numerator and reference bevacizumab the denominator|Based on previously published PK data for reference bevacizumab in metastatic colorectal cancer, we assumed a conservative inter-participant coefficient of variation for AUC of around 35%. A sample size of 51 patients in each treatment arm could show bioequivalence with a nominal power of 90% and an α of 0·05, if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80%-125%.||109.0|90.5|
91629615|NCT02069704|183151666|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|100.0|||||TWO_SIDED|90.0|90.2|112.0||||||||112.0|90.2|
91629616|NCT00554853|183151679|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANCOVA|||||||0.63
91629617|NCT02861118|183151680|OTHER|||||||0.024|||||||Regression, Logistic|||IBD||||0.024
91629618|NCT02861118|183151680|OTHER|||||||0.006|||||||Regression, Logistic|||Corticosteroids||||0.006
91629619|NCT02861118|183151680|OTHER|||||||0.006|||||||Regression, Logistic|||Chronic Obstructive Pulmonary Disease||||0.006
91629620|NCT02861118|183151681|OTHER|||||||0.044|||||||Regression, Logistic|||IBD||||0.044
91629621|NCT02861118|183151681|OTHER|||||||0.003|||||||Regression, Logistic|||Corticosteroids||||0.003
91629622|NCT02861118|183151681|OTHER|||||||0.003|||||||Regression, Logistic|||Myocardial Infarction||||0.003
91629623|NCT02861118|183151682|OTHER|||||||0.007|||||||Regression, Logistic|||Corticosteroids||||0.007
91629624|NCT02861118|183151683|OTHER|||||||0.002|||||||Regression, Logistic|||Corticosteroids||||0.002
91629625|NCT02861118|183151683|OTHER|||||||0.003|||||||Regression, Logistic|||Skin Disease||||0.003
91629626|NCT01975376|183151702|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.930905|TWO_SIDED|95.0|0.8|1.22|||Log Rank|||Hazard ratio and 95 percent (%) Confidence Interval (CI) were from a Cox proportional hazards model stratified by geographic region and low density lipoprotein cholesterol (LDL-C) at pre-screening (less than \[\<\] 100 milligrams per deciliters \[mg/dL\], greater than and equal to \[\>=\] 100 mg/dL) with treatment as a co-variate.||1.22|0.80|0.930905
91629627|NCT01975376|183151703|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.784265|TWO_SIDED|95.0|0.82|1.3|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.30|0.82|0.784265
91629628|NCT01975376|183151704|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.892441|TWO_SIDED|95.0|0.81|1.2|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.20|0.81|0.892441
91629629|NCT01975376|183151705|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.845797|TWO_SIDED|95.0|0.83|1.26|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.26|0.83|0.845797
91629630|NCT01975376|183151706|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.431903|TWO_SIDED|95.0|0.49|1.36|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.36|0.49|0.431903
91629631|NCT01975376|183151707|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.883797|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.21|0.80|0.883797
91525570|NCT00649389|182926345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
91665009|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-14.56|||<|0.001|TWO_SIDED|95.0|-22.89|-6.24|||Mixed models repeated measures analysis|||Week 12||-6.24|-22.89|<0.001
91665010|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.5|||<|0.001|TWO_SIDED|95.0|-36.83|-20.16|||Mixed models repeated measures analysis|||Week 12||-20.16|-36.83|<0.001
91665011|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.67|||<|0.001|TWO_SIDED|95.0|-27.07|-12.27|||Mixed models repeated measures analysis|||Week 24||-12.27|-27.07|<0.001
91665012|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.17|||<|0.001|TWO_SIDED|95.0|-35.52|-20.82|||Mixed models repeated measures analysis|||Week 24||-20.82|-35.52|<0.001
91665013|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.41|||<|0.001|TWO_SIDED|95.0|-32.73|-18.09|||Mixed models repeated measures analysis|||Week 24||-18.09|-32.73|<0.001
91482852|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.4709|TWO_SIDED|95.0|-3.85|1.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.81|-3.85|0.4709
91482853|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.4128|TWO_SIDED|95.0|-1.7|4.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||4.07|-1.70|0.4128
91629632|NCT01975376|183151708|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.45569|TWO_SIDED|95.0|0.74|1.95|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.95|0.74|0.455690
91629633|NCT01975376|183151709|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469496|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.84|0.469496
91629634|NCT01975376|183151710|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.633022|TWO_SIDED|95.0|0.26|9.23|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||9.23|0.26|0.633022
91629635|NCT01975376|183151711|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.46765|TWO_SIDED|95.0|0.83|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.83|0.467650
91665014|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.72|||<|0.001|TWO_SIDED|95.0|-19.35|-6.09|||Mixed models repeated measures analysis|||Week 24||-6.09|-19.35|<0.001
91665015|NCT01592240|183223115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.85|||<|0.001|TWO_SIDED|95.0|-23.47|-10.23|||Mixed models repeated measures analysis|||Week 24||-10.23|-23.47|<0.001
91629636|NCT01975376|183151712|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015462|TWO_SIDED|95.0|0.32|0.89|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.89|0.32|0.015462
91665016|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.58|||<|0.001|TWO_SIDED|95.0|-29.23|-13.92|||Mixed models repeated measures analysis|||Week 12||-13.92|-29.23|<0.001
91665017|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.54|||<|0.001|TWO_SIDED|95.0|-38.19|-22.89|||Mixed models repeated measures analysis|||Week 12||-22.89|-38.19|<0.001
91665018|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.95|||<|0.001|TWO_SIDED|95.0|-43.59|-28.31|||Mixed models repeated measures analysis|||Week 12||-28.31|-43.59|<0.001
91665019|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.14|||<|0.001|TWO_SIDED|95.0|-25.87|-8.41|||Mixed models repeated measures analysis|||Week 12||-8.41|-25.87|<0.001
91629637|NCT01975376|183151713|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.011863|TWO_SIDED|95.0|0.33|0.88|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.88|0.33|0.011863
91665020|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.72|||<|0.001|TWO_SIDED|95.0|-39.45|-21.98|||Mixed models repeated measures analysis|||Week 12||-21.98|-39.45|<0.001
91665021|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.09|||<|0.001|TWO_SIDED|95.0|-30.32|-13.86|||Mixed models repeated measures analysis|||Week 24||-13.86|-30.32|<0.001
91665022|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.95|||<|0.001|TWO_SIDED|95.0|-39.13|-22.77|||Mixed models repeated measures analysis|||Week 24||-22.77|-39.13|<0.001
91665023|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.23|||<|0.001|TWO_SIDED|95.0|-35.38|-19.09|||Mixed models repeated measures analysis|||Week 24||-19.09|-35.38|<0.001
91665024|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.34|||<|0.001|TWO_SIDED|95.0|-22.9|-7.78|||Mixed models repeated measures analysis|||Week 24||-7.78|-22.90|<0.001
91665025|NCT01592240|183223116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.15|||<|0.001|TWO_SIDED|95.0|-26.7|-11.59|||Mixed models repeated measures analysis|||Week 24||-11.59|-26.70|<0.001
91665026|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.77||||0.667|TWO_SIDED|95.0|-6.33|9.88|||Mixed models repeated measures analysis|||Week 12||9.88|-6.33|0.667
91665027|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.44||||0.187|TWO_SIDED|95.0|-2.66|13.54|||Mixed models repeated measures analysis|||Week 12||13.54|-2.66|0.187
91714239|NCT01656395|183320225|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.958|TWO_SIDED|95.0|-19.92|21.007|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||21.007|-19.92|0.958
91714240|NCT01656395|183320225|SUPERIORITY||Mean Difference (Final Values)|6.251||||0.559|TWO_SIDED|95.0|-14.81|27.307|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||27.307|-14.81|0.559
91714241|NCT01656395|183320225|SUPERIORITY||Median Difference (Final Values)|9.575||||0.374|TWO_SIDED|95.0|-11.62|30.766|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||30.766|-11.62|0.374
91714242|NCT01656395|183320225|SUPERIORITY||Mean Difference (Final Values)|5.114||||0.618|TWO_SIDED|95.0|-15.04|25.272|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||25.272|-15.04|0.618
91714243|NCT01656395|183320225|SUPERIORITY||Mean Difference (Final Values)|-1.604||||0.876|TWO_SIDED|95.0|-21.76|18.554|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||18.554|-21.76|0.876
91629638|NCT01975376|183151714|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.316066|TWO_SIDED|95.0|0.12|2.0|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||2.00|0.12|0.316066
91792109|NCT03036800|183461987|SUPERIORITY||Mean Difference (Net)|-9.59|||<|0.001|TWO_SIDED|95.0|-11.3|-7.88|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-7.88|-11.30|<0.001
91525571|NCT00649389|182926345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
91629639|NCT01975376|183151715|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.020328|TWO_SIDED|95.0|0.3|0.91|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.91|0.30|0.020328
91629640|NCT01975376|183151716|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.367069|TWO_SIDED|95.0|0.53|1.27|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.27|0.53|0.367069
91665028|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.82||||0.352|TWO_SIDED|95.0|-4.25|11.9|||Mixed models repeated measures analysis|||Week 12||11.90|-4.25|0.352
91665029|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.6||||0.09|TWO_SIDED|95.0|-0.89|12.09|||Mixed models repeated measures analysis|||Week 12||12.09|-0.89|0.090
91665030|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.36||||0.184|TWO_SIDED|95.0|-2.1|10.82|||Mixed models repeated measures analysis|||Week 12||10.82|-2.10|0.184
91665031|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.59||||0.879|TWO_SIDED|95.0|-7.09|8.28|||Mixed models repeated measures analysis|||Week 24||8.28|-7.09|0.879
91665032|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.911|TWO_SIDED|95.0|-7.17|8.02|||Mixed models repeated measures analysis|||Week 24||8.02|-7.17|0.911
91665033|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.283|TWO_SIDED|95.0|-3.44|11.69|||Mixed models repeated measures analysis|||Week 24||11.69|-3.44|0.283
91629641|NCT01975376|183151717|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.443081|TWO_SIDED|95.0|0.56|1.29|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.29|0.56|0.443081
91629642|NCT01975376|183151718|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.343817|TWO_SIDED|95.0|0.71|1.12|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.12|0.71|0.343817
91629643|NCT01975376|183151719|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.889065|TWO_SIDED|95.0|0.59|1.85|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.85|0.59|0.889065
91665034|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41||||0.728|TWO_SIDED|95.0|-9.41|6.59|||Mixed models repeated measures analysis|||Week 24||6.59|-9.41|0.728
91665035|NCT01592240|183223117|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19||||0.587|TWO_SIDED|95.0|-10.13|5.75|||Mixed models repeated measures analysis|||Week 24||5.75|-10.13|0.587
91665036|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66||||0.89|TWO_SIDED|95.0|-10.05|8.74|||Mixed models repeated measures analysis|||Week 12||8.74|-10.05|0.890
91665037|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.32||||0.625|TWO_SIDED|95.0|-7.04|11.68|||Mixed models repeated measures analysis|||Week 12||11.68|-7.04|0.625
91665038|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.54||||0.172|TWO_SIDED|95.0|-2.86|15.94|||Mixed models repeated measures analysis|||Week 12||15.94|-2.86|0.172
91665039|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.5||||0.109|TWO_SIDED|95.0|-0.79|7.8|||Mixed models repeated measures analysis|||Week 12||7.80|-0.79|0.109
91665040|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.67||||0.218|TWO_SIDED|95.0|-1.6|6.94|||Mixed models repeated measures analysis|||Week 12||6.94|-1.60|0.218
91482854|NCT01227564|182839160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.9478|TWO_SIDED|95.0|-2.41|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.58|-2.41|0.9478
91665041|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86||||0.812|TWO_SIDED|95.0|-8.01|6.29|||Mixed models repeated measures analysis|||Week 24||6.29|-8.01|0.812
91665042|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.749|TWO_SIDED|95.0|-8.24|5.94|||Mixed models repeated measures analysis|||Week 24||5.94|-8.24|0.749
91665043|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.82||||0.108|TWO_SIDED|95.0|-1.29|12.93|||Mixed models repeated measures analysis|||Week 24||12.93|-1.29|0.108
91665044|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.752|TWO_SIDED|95.0|-5.99|4.34|||Mixed models repeated measures analysis|||Week 24||4.34|-5.99|0.752
91665045|NCT01592240|183223118|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.55||||0.55|TWO_SIDED|95.0|-6.68|3.57|||Mixed models repeated measures analysis|||Week 24||3.57|-6.68|0.550
91665046|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.893|TWO_SIDED|95.0|-2.62|3.0|||Mixed models repeated measures analysis|||Week 12||3.00|-2.62|0.893
91792110|NCT03036800|183461988|SUPERIORITY||Mean Difference (Net)|-13.51|||<|0.001|TWO_SIDED|95.0|-15.51|-11.51|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-11.51|-15.51|<0.001
91665047|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.33||||0.355|TWO_SIDED|95.0|-1.49|4.15|||Mixed models repeated measures analysis|||Week 12||4.15|-1.49|0.355
91629644|NCT01975376|183151720|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.308388|TWO_SIDED|95.0|0.69|1.13|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.13|0.69|0.308388
91629645|NCT01975376|183151721|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.874835|TWO_SIDED|95.0|0.74|1.42|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.42|0.74|0.874835
91629646|NCT01975376|183151722|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.526269|TWO_SIDED|95.0|0.79|1.6|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.60|0.79|0.526269
91665048|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64||||0.655|TWO_SIDED|95.0|-3.45|2.17|||Mixed models repeated measures analysis|||Week 12||2.17|-3.45|0.655
91665049|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.49||||0.719|TWO_SIDED|95.0|-3.2|2.21|||Mixed models repeated measures analysis|||Week 12||2.21|-3.20|0.719
91665050|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.41||||0.768|TWO_SIDED|95.0|-2.31|3.12|||Mixed models repeated measures analysis|||Week 12||3.12|-2.31|0.768
91665051|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.66||||0.199|TWO_SIDED|95.0|-0.88|4.2|||Mixed models repeated measures analysis|||Week 24||4.20|-0.88|0.199
91629647|NCT01975376|183151723|SUPERIORITY||LS-mean difference|-60.57|||<|0.001|TWO_SIDED|95.0|-61.43|-59.71|||Mixed Effect Model Repeat Measurement|||Lease Square (LS)- mean differences, associated 95% CI, and p-values were from a mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-59.71|-61.43|<0.001
91665052|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.9||||0.483|TWO_SIDED|95.0|-1.62|3.41|||Mixed models repeated measures analysis|||Week 24||3.41|-1.62|0.483
91665053|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.03||||0.42|TWO_SIDED|95.0|-1.49|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.49|0.420
91665054|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69||||0.488|TWO_SIDED|95.0|-2.67|1.28|||Mixed models repeated measures analysis|||Week 24||1.28|-2.67|0.488
91665055|NCT01592240|183223119|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.694|TWO_SIDED|95.0|-2.36|1.58|||Mixed models repeated measures analysis|||Week 24||1.58|-2.36|0.694
91665056|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|10.29||||0.527|TWO_SIDED|95.0|-21.73|42.3|||Mixed models repeated measures analysis|||Week 12||42.30|-21.73|0.527
91665057|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39||||0.981|TWO_SIDED|95.0|-31.49|32.26|||Mixed models repeated measures analysis|||Week 12||32.26|-31.49|0.981
91665058|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54||||0.974|TWO_SIDED|95.0|-31.72|32.8|||Mixed models repeated measures analysis|||Week 12||32.80|-31.72|0.974
91665059|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.58||||0.64|TWO_SIDED|95.0|-8.25|5.09|||Mixed models repeated measures analysis|||Week 12||5.09|-8.25|0.640
91665060|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.08||||0.75|TWO_SIDED|95.0|-5.61|7.77|||Mixed models repeated measures analysis|||Week 12||7.77|-5.61|0.750
91665061|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|9.8||||0.509|TWO_SIDED|95.0|-19.41|39.01|||Mixed models repeated measures analysis|||Week 24||39.01|-19.41|0.509
91665062|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.69||||0.855|TWO_SIDED|95.0|-31.76|26.38|||Mixed models repeated measures analysis|||Week 24||26.38|-31.76|0.855
91665063|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.04||||0.839|TWO_SIDED|95.0|-26.39|32.47|||Mixed models repeated measures analysis|||Week 24||32.47|-26.39|0.839
91525572|NCT00649389|182926346|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91665064|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99||||0.392|TWO_SIDED|95.0|-6.57|2.59|||Mixed models repeated measures analysis|||Week 24||2.59|-6.57|0.392
91665065|NCT01592240|183223120|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.33||||0.565|TWO_SIDED|95.0|-5.91|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-5.91|0.565
91665066|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.964|||<|0.001|TWO_SIDED|95.0|3.997|56.02|||Regression, Logistic|||Week 12, Less than 100 mg/dL||56.020|3.997|<0.001
91665067|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.615|||<|0.001|TWO_SIDED|95.0|7.984|308.328|||Regression, Logistic|||Week 12, Less than 100 mg/dL||308.328|7.984|<0.001
91665068|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.842|||<|0.001|TWO_SIDED|95.0|3.674|44.892|||Regression, Logistic|||Week 12, Less than 100 mg/dL||44.892|3.674|<0.001
91665069|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.107||||0.01|TWO_SIDED|95.0|1.304|7.401|||Regression, Logistic|||Week 12, Less than 100 mg/dL||7.401|1.304|0.010
91714244|NCT01656395|183320226|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.682|TWO_SIDED|95.0|-0.288|0.44|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.440|-0.288|0.682
91525573|NCT00649389|182926346|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91665070|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.048|||<|0.001|TWO_SIDED|95.0|2.402|15.225|||Regression, Logistic|||Week 12, Less than 100 mg/dL||15.225|2.402|<0.001
91665071|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.773|||<|0.001|TWO_SIDED|95.0|3.932|41.495|||Regression, Logistic|||Week 24, Less than 100 mg/dL||41.495|3.932|<0.001
91665072|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.886|||<|0.001|TWO_SIDED|95.0|8.33|163.335|||Regression, Logistic|||Week 24, Less than 100 mg/dL||163.335|8.330|<0.001
91665073|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.75|||<|0.001|TWO_SIDED|95.0|5.741|75.006|||Regression, Logistic|||Week 24, Less than 100 mg/dL||75.006|5.741|<0.001
91665074|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.219||||0.001|TWO_SIDED|95.0|2.061|18.764|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.764|2.061|0.001
91665075|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.205||||0.001|TWO_SIDED|95.0|2.06|18.693|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.693|2.060|0.001
91665076|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.703|||<|0.001|TWO_SIDED|95.0|5.752|133.423|||Regression, Logistic|||Week 12, Less than 70 mg/dL||133.423|5.752|<0.001
91665077|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.177|||<|0.001|TWO_SIDED|95.0|13.783|367.564|||Regression, Logistic|||Week 12, Less than 70 mg/dL||367.564|13.783|<0.001
91665078|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|100.667|||<|0.001|TWO_SIDED|95.0|19.855|510.387|||Regression, Logistic|||Week 12, Less than 70 mg/dL||510.387|19.855|<0.001
91665079|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 70 mg/dL.||||<0.001
91629648|NCT01975376|183151724|SUPERIORITY||LS-mean difference|-54.7|||<|0.001|TWO_SIDED|95.0|-55.48|-53.92|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-53.92|-55.48|<0.001
91629649|NCT01975376|183151725|SUPERIORITY||LS-mean difference|-46.72|||<|0.001|TWO_SIDED|95.0|-47.68|-45.76|||ANCOVA|||LS- mean difference and associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-45.76|-47.68|<0.001
91629650|NCT01975376|183151726|SUPERIORITY||LS-mean difference|-54.88|||<|0.001|TWO_SIDED|95.0|-55.66|-54.09|||Mixed Effect Model Repeat Measurement|||Non-HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-54.09|-55.66|<0.001
91629651|NCT01975376|183151726|SUPERIORITY||LS-mean difference|-36.51|||<|0.001|TWO_SIDED|95.0|-37.07|-35.95|||Mixed Effect Model Repeat Measurement|||Total cholesterol: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-35.95|-37.07|<0.001
91629652|NCT01975376|183151726|SUPERIORITY||LS-mean difference|-20.17|||<|0.001|TWO_SIDED|95.0|-21.42|-18.93|||Mixed Effect Model Repeat Measurement|||VLDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-18.93|-21.42|<0.001
91629653|NCT01975376|183151726|SUPERIORITY||LS-Mean Difference|-30.25|||<|0.001|TWO_SIDED|95.0|-32.44|-28.07|||Mixed Effect Model Repeat Measurement|||RLP-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-28.07|-32.44|<0.001
91482855|NCT01227564|182839161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.7146|TWO_SIDED|95.0|-3.4|2.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||2.35|-3.40|0.7146
91629654|NCT01975376|183151726|SUPERIORITY||LS-Mean Difference|-58.55|||<|0.001|TWO_SIDED|95.0|-59.42|-57.69|||Mixed Effect Model Repeat Measurement|||Apo B: LS -mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-57.69|-59.42|<0.001
91629655|NCT01975376|183151726|SUPERIORITY||LS-Mean Difference|6.14|||<|0.001|TWO_SIDED|95.0|5.69|6.59|||Mixed Effect Model Repeat Measurement|||HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||6.59|5.69|<0.001
91629656|NCT01975376|183151726|SUPERIORITY||LS-Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|3.02|4.03|||Mixed Effect Model Repeat Measurement|||Apo A-I: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||4.03|3.02|<0.001
91629657|NCT01975376|183151727|SUPERIORITY||LS-mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.66|0.68|||Mixed Effect Model Repeat Measurement|||Lp (a): LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.68|0.66|<0.001
91629658|NCT01975376|183151727|SUPERIORITY||LS-mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.8|0.81|||Mixed Effect Model Repeat Measurement|||Triglycerides: LS- mean differences and associated 95% CI, and p-values were from an MMRM model through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.81|0.80|<0.001
91629659|NCT01975376|183151728|SUPERIORITY||LS-mean difference|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.1|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||1.10|1.03|<0.001
91629660|NCT00356057|183151729|SUPERIORITY|||||||0.437|||||||t-test, 2 sided|||||||0.437
91629661|NCT00356057|183151729|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
91665080|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.941|||<|0.001|TWO_SIDED|95.0|6.336|98.169|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.169|6.336|<0.001
91665081|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|80.004|||<|0.001|TWO_SIDED|95.0|18.094|353.742|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||353.742|18.094|<0.001
91665082|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.101|||<|0.001|TWO_SIDED|95.0|10.621|166.894|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||166.894|10.621|<0.001
91665083|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.023|TWO_SIDED|95.0|1.396|98.075|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.075|1.396|0.023
91665084|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.841|||<|0.001|TWO_SIDED|95.0|4.527|299.817|||Regression, Logistic|||Week 24, Less than 70 mg/dL||299.817|4.527|<0.001
91629662|NCT00356057|183151730|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0596|||||||t-test, 1 sided|||||||0.0596
91629663|NCT00356057|183151731|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0009|||||||t-test, 1 sided|||||||0.0009
91629664|NCT00356057|183151734|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
91629665|NCT00356057|183151734|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91629666|NCT00356057|183151738|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
91629667|NCT00356057|183151738|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91629668|NCT00356057|183151739|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
91629669|NCT00356057|183151739|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
91665085|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
91665086|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
91665087|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
91665088|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
91665089|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
91665090|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
91665091|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
91665092|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
91665093|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
91629670|NCT00356057|183151740|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91629671|NCT00356057|183151740|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91629672|NCT00356057|183151741|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
91629673|NCT00356057|183151741|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
91629674|NCT01451398|183151742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.57|-0.23|||Mixed Models Analysis|Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment\*Visit), using AR(1) variance/covariance structure.||||-0.23|-0.57|<0.0001
91629675|NCT01451398|183151743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.0005|TWO_SIDED|95.0|1.55|4.8|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||4.80|1.55|0.0005
91629676|NCT01451398|183151744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.361||||0.0021|TWO_SIDED|95.0|1.7|11.17|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||11.17|1.70|0.0021
91629677|NCT01451398|183151745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.42|STANDARD_ERROR_OF_MEAN|5.4||0.1698|TWO_SIDED|95.0|-18.03|3.18|||Mixed Models Analysis|"Model: FPG = Baseline FPG + Region + Pooled OAD Stratum + Visit + Treatment + (Treatment \* Visit)~Variance/Covariance Matrix is Autoregression 1"||||3.18|-18.03|0.1698
91629678|NCT01451398|183151748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.018|||TWO_SIDED|95.0|-0.12|-0.05|||Mixed Models Analysis|FEV1 = Baseline FEV1 + Age + Gender + Race + Height + Visit + Treatment + (Treatment\*Visit)||||-0.05|-0.12|
91629679|NCT01451398|183151751|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative binomial regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||<0.0001
91629680|NCT01451398|183151752|SUPERIORITY_OR_OTHER|||||||0.2024|||||||Negative Binomial Regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||0.2024
91629681|NCT01451398|183151755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.365|<|0.0001|TWO_SIDED|95.0|0.9|2.34|||ANCOVA||Model: Baseline Weight + Change in HbA1c at Week 24 + Region + OAD Stratum + Treatment|||2.34|0.90|<0.0001
91629682|NCT00565812|183151804|SUPERIORITY_OR_OTHER||Difference in Slopes|0.012|STANDARD_ERROR_OF_MEAN|0.018||0.50877|TWO_SIDED|95.0|-0.023|0.046|||Mixed Models Analysis|||Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group\*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG\*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.||0.046|-0.023|0.508770
91629683|NCT00565812|183151804|SUPERIORITY_OR_OTHER||Difference in Slopes|0.005|STANDARD_ERROR_OF_MEAN|0.017||0.754074|TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis|||Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group\*time interaction, (collapsed) KLG, KLG\*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.||0.040|-0.029|0.754074
91629684|NCT00565812|183151805|SUPERIORITY_OR_OTHER||Difference in slopes|0.023|STANDARD_ERROR_OF_MEAN|0.023||0.312|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.312
91629685|NCT00565812|183151805|SUPERIORITY_OR_OTHER||Difference in slopes|0.022|STANDARD_ERROR_OF_MEAN|0.023||0.327|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.327
91629686|NCT00565812|183151806|SUPERIORITY_OR_OTHER||Difference in slopes|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.881|TWO_SIDED|95.0|-0.046|0.054|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.054|-0.046|0.881
91629687|NCT00565812|183151806|SUPERIORITY_OR_OTHER||Difference in slopes|-0.007|STANDARD_ERROR_OF_MEAN|0.025||0.78|TWO_SIDED|95.0|-0.056|0.042|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.042|-0.056|0.780
91629688|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.84||0.639|TWO_SIDED|95.0|-1.26|2.05|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.05|-1.26|0.639
91629689|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.84||0.957|TWO_SIDED|95.0|-1.61|1.7|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.70|-1.61|0.957
91629690|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.96||0.893|TWO_SIDED|95.0|-1.76|2.01|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-1.76|0.893
91665094|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.587||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
91525574|NCT00649389|182926346|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||0.0001
91665095|NCT01592240|183223134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL.||||<0.001
91665096|NCT01592240|183223134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.925||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
91665097|NCT00488774|183223135|SUPERIORITY_OR_OTHER|||||||0.467|||||||Chi-squared|||||||0.467
91665098|NCT00488774|183223135|SUPERIORITY_OR_OTHER|||||||0.081|||||||Chi-squared|||||||0.081
91665099|NCT00488774|183223135|SUPERIORITY_OR_OTHER|||||||0.145|||||||Chi-squared|||||||0.145
91665100|NCT00488774|183223136|SUPERIORITY_OR_OTHER|||||||0.832|||||||Chi-squared|||||||0.832
91665101|NCT00488774|183223136|SUPERIORITY_OR_OTHER|||||||0.37|||||||Chi-squared|||||||0.370
91665102|NCT00488774|183223136|SUPERIORITY_OR_OTHER|||||||0.702|||||||Chi-squared|||||||0.702
91665103|NCT05523895|183223137|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.52||0.2986|TWO_SIDED|95.0|-4.6|1.4|||Mixed Models Analysis|||||1.4|-4.6|0.2986
91665104|NCT05523895|183223137|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.49||0.2859|TWO_SIDED|95.0|-4.5|1.3|||Mixed Models Analysis|||||1.3|-4.5|0.2859
91665105|NCT05099380|183223151|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-0.6|6.7|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a two independent sample t test with a 2-sided type I error of 0.05, there would be enough power (i.e., 80%) for testing non-inferiority of the Test relative to the Control with 286 subjects (143 for each lens group) competing the study assuming the Test was 2 points higher than the Control.||6.7|-0.6|
91665106|NCT05099380|183223152|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.05.|Least-square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.02|0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a linear mixed model-based method with a 2-sided type I error of 0.05, there would be enough power (i.e., at least 80%) for testing non-inferiority of the Test relative to the Control with 16 subjects (8 for each lens group) competing the study assuming no difference between the Test and the Control.||0.01|-0.02|
91665107|NCT05099380|183223153|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.05.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 240 subjects (120 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
91665108|NCT05099380|183223154|NON_INFERIORITY|Non- inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.1.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 140 subjects (70 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
91665109|NCT05099380|183223155|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-4.8|4.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 73% for CLUE comfort using a two independent sample t test with a 2-sided type I error of 0.05.||4.5|-4.8|
91665110|NCT05099380|183223156|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-6.0|2.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points lower than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 23% for CLUE handling using a two independent sample t test with a 2-sided type I error of 0.05.||2.3|-6.0|
91665111|NCT05099380|183223157|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the odds ratio was greater than 0.67.|Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.83|2.16|||Linear Mixed Model||Odds Ratio was calculated as Test over Control|"Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of Excellent rating for the Test was 10% higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 93% using a Pearson chi-square test for two proportions with a 2-sided type I error of 0.05."||2.16|0.83|
91691999|NCT03380429|183278462|OTHER||Mean Difference (Net)|-0.5||||0.4|TWO_SIDED|95.0|-1.6|0.6||p-value was calculated using Mixed Model Repeated Measures (MMRM).|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||0.6|-1.6|0.400
91525575|NCT00649389|182926346|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91629691|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.96||0.365|TWO_SIDED|95.0|-1.01|2.76|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.76|-1.01|0.365
91629692|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.05||0.678|TWO_SIDED|95.0|-1.63|2.51|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.51|-1.63|0.678
91629693|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|1.05||0.902|TWO_SIDED|95.0|-2.18|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-2.18|0.902
91629694|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|1.15||0.577|TWO_SIDED|95.0|-2.89|1.61|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-2.89|0.577
91792111|NCT03036800|183461989|SUPERIORITY||Mean Difference (Net)|-9.3|||<|0.001|TWO_SIDED|95.0|-12.35|-6.26|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-6.26|-12.35|<0.001
91629695|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.14||0.98|TWO_SIDED|95.0|-2.26|2.21|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-2.26|0.980
91629696|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.17||0.95|TWO_SIDED|95.0|-2.37|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-2.37|0.950
91629697|NCT00565812|183151807|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.17||0.292|TWO_SIDED|95.0|-3.53|1.06|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.06|-3.53|0.292
91629698|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.683|TWO_SIDED|95.0|-0.3|0.46|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-0.30|0.683
91629699|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.19||0.853|TWO_SIDED|95.0|-0.42|0.35|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.42|0.853
91629700|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.22||0.938|TWO_SIDED|95.0|-0.41|0.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.41|0.938
91629701|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.648|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-0.32|0.648
91629702|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.916|TWO_SIDED|95.0|-0.49|0.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.49|0.916
91629703|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.528|TWO_SIDED|95.0|-0.6|0.31|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.31|-0.60|0.528
91629704|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.365|TWO_SIDED|95.0|-0.73|0.27|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.73|0.365
91629705|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.328|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.25|-0.74|0.328
91629706|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.66|0.35|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.66|0.540
91629707|NCT00565812|183151808|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.26||0.423|TWO_SIDED|95.0|-0.71|0.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.30|-0.71|0.423
91629708|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.904|TWO_SIDED|95.0|-0.17|0.2|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.17|0.904
91629709|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.582|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.24|0.582
91629710|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.818|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-0.22|0.818
91629711|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.988|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.20|0.988
91629712|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.857|TWO_SIDED|95.0|-0.2|0.24|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.20|0.857
91629713|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.658|TWO_SIDED|95.0|-0.17|0.27|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.17|0.658
91629714|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.612|TWO_SIDED|95.0|-0.28|0.17|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.17|-0.28|0.612
91665112|NCT05099380|183223158|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval of the preference ratio was greater than 1.|Preference Ratio|2.4|||||TWO_SIDED|95.0|1.4|4.1|||Linear Mixed Model||Preference ratio was calculated as Study lens over Habitual lens within the Test lens group.|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of subjects preferring Study lens was 20% higher than preferring Habitual lens in the Test lens group, the estimated statistical power for testing superiority of the Test relative to the Habitual was 88% using a simulation approach with a 2-sided type I error of 0.05.||4.10|1.40|
91665113|NCT00545792|183223169|SUPERIORITY_OR_OTHER||Single point estiamte of 1-yr PFS|0.8|||||TWO_SIDED|95.0|0.56|0.94|||||The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.|Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.||0.94|0.56|
91629715|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.391|TWO_SIDED|95.0|-0.32|0.13|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.32|0.391
91629716|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||1|TWO_SIDED|95.0|-0.24|0.24|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.24|1.000
91629717|NCT00565812|183151809|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.086|TWO_SIDED|95.0|-0.45|0.03|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.03|-0.45|0.086
91629718|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.62||0.586|TWO_SIDED|95.0|-0.88|1.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.55|-0.88|0.586
91629719|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.789|TWO_SIDED|95.0|-1.05|1.38|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-1.05|0.789
91629720|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.69||0.821|TWO_SIDED|95.0|-1.21|1.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.52|-1.21|0.821
91629721|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.69||0.294|TWO_SIDED|95.0|-0.63|2.09|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|-0.63|0.294
91629722|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.76||0.532|TWO_SIDED|95.0|-1.02|1.97|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-1.02|0.532
91629723|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.76||0.938|TWO_SIDED|95.0|-1.55|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.55|0.938
91629724|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.83||0.68|TWO_SIDED|95.0|-1.97|1.29|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.29|-1.97|0.680
91629725|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.82||0.73|TWO_SIDED|95.0|-1.33|1.9|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.90|-1.33|0.730
91629726|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.901|TWO_SIDED|95.0|-1.55|1.76|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.55|0.901
91629727|NCT00565812|183151810|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.84||0.333|TWO_SIDED|95.0|-2.45|0.83|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-2.45|0.333
91629728|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|2.34|STANDARD_ERROR_OF_MEAN|1.36||0.086|TWO_SIDED|95.0|-0.33|5.01|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||5.01|-0.33|0.086
91629729|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.36||0.415|TWO_SIDED|95.0|-1.56|3.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.78|-1.56|0.415
91482856|NCT01227564|182839161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||0.2733|TWO_SIDED|95.0|-4.6|1.33||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.33|-4.60|0.2733
91629730|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.41||0.569|TWO_SIDED|95.0|-1.97|3.57|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.57|-1.97|0.569
91629731|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.41||0.374|TWO_SIDED|95.0|-1.51|4.02|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.02|-1.51|0.374
91629732|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|1.53||0.288|TWO_SIDED|95.0|-1.38|4.64|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.64|-1.38|0.288
91629733|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.52||0.44|TWO_SIDED|95.0|-1.81|4.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.17|-1.81|0.440
91629734|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|1.58||0.896|TWO_SIDED|95.0|-3.3|2.88|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.30|0.896
91629735|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.56||0.464|TWO_SIDED|95.0|-1.92|4.2|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.20|-1.92|0.464
91629736|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.57||0.901|TWO_SIDED|95.0|-3.27|2.88|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.27|0.901
91629737|NCT00565812|183151811|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.56||0.8|TWO_SIDED|95.0|-3.45|2.66|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.66|-3.45|0.800
91629738|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.048||0.984|TWO_SIDED|95.0|-0.093|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.093|0.984
91629739|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.046|STANDARD_ERROR_OF_MEAN|0.048||0.33|TWO_SIDED|95.0|-0.14|0.047|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.047|-0.140|0.330
91629740|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.308|TWO_SIDED|95.0|-0.146|0.046|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.046|-0.146|0.308
91629741|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.049||0.089|TWO_SIDED|95.0|-0.18|0.013|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.013|-0.180|0.089
91629742|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.035|STANDARD_ERROR_OF_MEAN|0.052||0.508|TWO_SIDED|95.0|-0.137|0.068|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.068|-0.137|0.508
91629743|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.49|TWO_SIDED|95.0|-0.137|0.066|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.066|-0.137|0.490
91665114|NCT01642277|183223174|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.94||||0.052|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For symptom-severity score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size and non-normal distributions of symptom severity scores. The null hypothesis is that there is no difference between the two groups in symptom severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) symptom severity than the other group.||||.052
91665115|NCT01642277|183223174|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.06||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group.||||.04
91665116|NCT01642277|183223174|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.176||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group.||||.03
91665117|NCT01642277|183223174|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.9||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group.||||.37
91665118|NCT01642277|183223174|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.02||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group.||||.04
91665119|NCT01642277|183223174|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.03||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group.||||.04
91665120|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.74||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the obstructive discomfort score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in obstructive discomfort, and and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) obstructive discomfort than the other group.||||.46
91665121|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.8||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group.||||.07
91482857|NCT01227564|182839161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3969|TWO_SIDED|95.0|-3.62|1.46||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.46|-3.62|0.3969
91665122|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.59||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group.||||.11
91629744|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.057||0.739|TWO_SIDED|95.0|-0.132|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.132|0.739
91665123|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.69||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group.||||.09
91482858|NCT01227564|182839161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.8566|TWO_SIDED|95.0|-2.43|2.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||2.92|-2.43|0.8566
91482859|NCT01227564|182839161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.346|TWO_SIDED|95.0|-3.98|1.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.42|-3.98|0.3460
91629745|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.057||0.376|TWO_SIDED|95.0|-0.162|0.061|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.061|-0.162|0.376
91629746|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.057||0.883|TWO_SIDED|95.0|-0.121|0.104|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.104|-0.121|0.883
91629747|NCT00565812|183151812|SUPERIORITY_OR_OTHER||LS mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.057||0.69|TWO_SIDED|95.0|-0.135|0.089|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.089|-0.135|0.690
91665124|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.68||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group.||||.09
91629748|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.044||0.849|TWO_SIDED|95.0|-0.078|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.078|0.849
91665125|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.23||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group.||||.82
91665126|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.92||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group.||||.06
91714245|NCT01656395|183320226|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.807|TWO_SIDED|95.0|-0.422|0.329|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.329|-0.422|0.807
91482860|NCT01227564|182839161|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.52||||0.6582|TWO_SIDED|95.0|-2.86|1.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.82|-2.86|0.6582
91525576|NCT00649389|182926346|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91629749|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.044||0.837|TWO_SIDED|95.0|-0.096|0.078|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.096|0.837
91525577|NCT00649389|182926346|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91629750|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.047||0.776|TWO_SIDED|95.0|-0.105|0.078|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.105|0.776
91629751|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.047||0.033|TWO_SIDED|95.0|-0.191|-0.008|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.008|-0.191|0.033
91629752|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.064|STANDARD_ERROR_OF_MEAN|0.05||0.201|TWO_SIDED|95.0|-0.163|0.034|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.034|-0.163|0.201
91629753|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED|95.0|-0.201|-0.006|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.006|-0.201|0.038
91629754|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.053||0.848|TWO_SIDED|95.0|-0.114|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.114|0.848
91629755|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.052||0.714|TWO_SIDED|95.0|-0.122|0.084|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.084|-0.122|0.714
91629756|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|0.025|STANDARD_ERROR_OF_MEAN|0.054||0.652|TWO_SIDED|95.0|-0.082|0.131|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.131|-0.082|0.652
91629757|NCT00565812|183151813|SUPERIORITY_OR_OTHER||LS mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.054||0.7|TWO_SIDED|95.0|-0.085|0.127|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.127|-0.085|0.700
91629758|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|1.68|STANDARD_ERROR_OF_MEAN|1.37||0.22|TWO_SIDED|95.0|-1.0|4.36|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.36|-1.00|0.220
91629759|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.36||0.997|TWO_SIDED|95.0|-2.67|2.68|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.68|-2.67|0.997
91629760|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|1.44||0.613|TWO_SIDED|95.0|-2.09|3.55|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.55|-2.09|0.613
91629761|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.44||0.964|TWO_SIDED|95.0|-2.75|2.88|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-2.75|0.964
91629762|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.49||0.872|TWO_SIDED|95.0|-2.69|3.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.17|-2.69|0.872
91665127|NCT01642277|183223175|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.85||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group.||||.07
91665128|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.751|1.03||||||Serogroup A: Lot 1 vs Lot 2||1.03|0.751|
91665129|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.985|||||TWO_SIDED|95.0|0.843|1.15||||||Serogroup A: Lot 2 vs Lot 3||1.15|0.843|
91665130|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.867|||||TWO_SIDED|95.0|0.74|1.02||||||Serogroup A: Lot 1 vs Lot 3||1.02|0.740|
91665131|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.888|1.29||||||Serogroup C: Lot 1 vs Lot 2||1.29|0.888|
91665132|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.866|||||TWO_SIDED|95.0|0.714|1.05||||||Serogroup C: Lot 2 vs Lot 3||1.05|0.714|
91665133|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.927|||||TWO_SIDED|95.0|0.766|1.12||||||Serogroup C: Lot 1 vs Lot 3||1.12|0.766|
91665134|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.869|1.19||||||Serogroup Y: Lot 1 vs Lot 2||1.19|0.869|
91665135|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.961|||||TWO_SIDED|95.0|0.816|1.13||||||Serogroup Y: Lot 2 vs Lot 3||1.13|0.816|
91665136|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.975|||||TWO_SIDED|95.0|0.829|1.15||||||Serogroup Y: Lot 1 vs Lot 3||1.15|0.829|
91665137|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.878|1.22||||||Serogroup W: Lot 1 vs Lot 2||1.22|0.878|
91665138|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.791|1.11||||||Serogroup W: Lot 2 vs Lot 3||1.11|0.791|
91665139|NCT02842853|183223189|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.818|1.15||||||Serogroup W: Lot 1 vs Lot 3||1.15|0.818|
91665140|NCT02842853|183223190|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.8|23.5||||||Serogroup A||23.5|14.8|
91665141|NCT02842853|183223190|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|40.9|||||TWO_SIDED|95.0|36.7|45.0||||||Serogroup C||45|36.7|
91665142|NCT02842853|183223190|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.1|||||TWO_SIDED|95.0|14.5|21.9||||||Serogroup Y||21.9|14.5|
91665143|NCT02842853|183223190|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.9|23.3||||||Serogroup W||23.3|14.9|
91665144|NCT02842853|183223191|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.6|||||TWO_SIDED|95.0|13.5|25.8||||||Serogroup A||25.8|13.5|
91665145|NCT02842853|183223191|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|41.1|||||TWO_SIDED|95.0|35.0|46.9||||||Serogroup C||46.9|35.0|
91665146|NCT02842853|183223191|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|27.4|||||TWO_SIDED|95.0|21.7|33.3||||||Serogroup Y||33.3|21.7|
91665147|NCT02842853|183223191|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|26.8|||||TWO_SIDED|95.0|20.7|32.9||||||Serogroup W||32.9|20.7|
91665148|NCT02842853|183223192|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.7|||||TWO_SIDED|95.0|12.5|24.9||||||Serogroup A||24.9|12.5|
91629763|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.48||0.947|TWO_SIDED|95.0|-2.81|3.01|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.01|-2.81|0.947
91629764|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.62||0.927|TWO_SIDED|95.0|-3.03|3.33|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.33|-3.03|0.927
91629765|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|1.61||0.547|TWO_SIDED|95.0|-2.18|4.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.12|-2.18|0.547
91629766|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.58||0.304|TWO_SIDED|95.0|-1.47|4.71|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.71|-1.47|0.304
91629767|NCT00565812|183151814|SUPERIORITY_OR_OTHER||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|1.57||0.679|TWO_SIDED|95.0|-3.73|2.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.43|-3.73|0.679
91629768|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.11||0.738|TWO_SIDED|95.0|-1.8|2.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.55|-1.80|0.738
91665149|NCT02842853|183223192|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|42.3|||||TWO_SIDED|95.0|36.6|48.0||||||Serogroup C||48.0|36.6|
91665150|NCT02842853|183223192|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|10.0|||||TWO_SIDED|95.0|6.18|14.5||||||Serogroup Y||14.5|6.18|
91665151|NCT02842853|183223192|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|12.5|||||TWO_SIDED|95.0|7.22|18.2||||||Serogroup W||18.2|7.22|
91665152|NCT02842853|183223193|OTHER||Percentage Difference|-5.4|||||TWO_SIDED|95.0|-9.59|-1.16||||||Serogroup A: Lot 1 vs Lot 2||-1.16|-9.59|
91629769|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.11||0.632|TWO_SIDED|95.0|-2.7|1.64|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-2.70|0.632
91629770|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|1.21||0.736|TWO_SIDED|95.0|-2.77|1.96|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-2.77|0.736
91629771|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|1.21||0.811|TWO_SIDED|95.0|-2.66|2.08|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.08|-2.66|0.811
91629772|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|1.27||0.335|TWO_SIDED|95.0|-3.71|1.26|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.26|-3.71|0.335
91665153|NCT02842853|183223193|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-1.3|7.01||||||Serogroup A: Lot 2 vs Lot 3||7.01|-1.3|
91629773|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.966|TWO_SIDED|95.0|-2.52|2.41|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.41|-2.52|0.966
91665154|NCT02842853|183223193|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-6.78|1.74||||||Serogroup A: Lot 1 vs Lot 3||1.74|-6.78|
91665155|NCT02842853|183223193|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-1.58|4.28||||||Serogroup C: Lot 1 vs Lot 2||4.28|-1.58|
91665156|NCT02842853|183223193|OTHER||Percentage Difference|2.4|||||TWO_SIDED|95.0|-0.74|5.54||||||Serogroup C: Lot 2 vs Lot 3||5.54|-0.740|
91629774|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|1.38||0.299|TWO_SIDED|95.0|-4.16|1.28|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.28|-4.16|0.299
91629775|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.37||0.925|TWO_SIDED|95.0|-2.56|2.82|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.82|-2.56|0.925
91629776|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.39||0.676|TWO_SIDED|95.0|-2.14|3.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|-2.14|0.676
91629777|NCT00565812|183151815|SUPERIORITY_OR_OTHER||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|1.38||0.732|TWO_SIDED|95.0|-3.18|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-3.18|0.732
91629778|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2||0.911|TWO_SIDED|95.0|-2.22|2.49|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.49|-2.22|0.911
91665157|NCT02842853|183223193|OTHER||Percentage Difference|3.7|||||TWO_SIDED|95.0|0.708|6.79||||||Serogroup C: Lot 1 vs Lot 3||6.79|0.708|
91665158|NCT02842853|183223193|OTHER||Percentage Difference|0.5|||||TWO_SIDED|95.0|-2.14|3.07||||||Serogroup Y: Lot 1 vs Lot 2||3.07|-2.14|
91665159|NCT02842853|183223193|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-0.763|4.79||||||Serogroup Y: Lot 2 vs Lot 3||4.79|-0.763|
91665160|NCT02842853|183223193|OTHER||Percentage Difference|2.5|||||TWO_SIDED|95.0|-0.248|5.2||||||Serogroup Y: Lot 1 vs Lot 3||5.20|-0.248|
91665161|NCT02842853|183223193|OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-3.0|4.54||||||Serogroup W: Lot 1 vs Lot 2||4.54|-3.00|
91665162|NCT02842853|183223193|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-1.84|5.89||||||Serogroup W: Lot 2 vs Lot 3||5.89|-1.84|
91714246|NCT01656395|183320226|SUPERIORITY||Mean Difference (Final Values)|0.165||||0.403|TWO_SIDED|95.0|-0.222|0.552|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.552|-0.222|0.403
91629779|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-3.16|1.54|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-3.16|0.500
91629780|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.26||0.596|TWO_SIDED|95.0|-1.81|3.15|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.15|-1.81|0.596
91629781|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.26||0.979|TWO_SIDED|95.0|-2.51|2.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-2.51|0.979
91629782|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|1.33||0.659|TWO_SIDED|95.0|-3.2|2.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.03|-3.20|0.659
91665163|NCT02842853|183223193|OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.02|6.61||||||Serogroup W: Lot 1 vs Lot 3||6.61|-1.02|
91665164|NCT02842853|183223194|OTHER||GMT Ratio|1.93|||||TWO_SIDED|95.0|1.67|2.24||||||Serogroup A||2.24|1.67|
91665165|NCT02842853|183223194|OTHER||GMT Ratio|8.05|||||TWO_SIDED|95.0|6.58|9.84||||||Serogroup C||9.84|6.58|
91665166|NCT02842853|183223194|OTHER||GMT Ratio|3.22|||||TWO_SIDED|95.0|2.71|3.84||||||Serogroup Y||3.84|2.71|
91665167|NCT02842853|183223194|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.61|2.24||||||Serogroup W||2.24|1.61|
91665168|NCT03317444|183223200|SUPERIORITY||Treatment difference in % of subjects|36.7|||<|0.0001|TWO_SIDED|95.0|23.5|48.9|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||48.9|23.5|< 0.0001
91665169|NCT03317444|183223200|SUPERIORITY||Treatment difference in % of subjects|34.5|||<|0.0001|TWO_SIDED|95.0|21.2|46.8|||Fisher Exact|||% Subjects with ≥ 4 mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||46.8|21.2|< 0.0001
91665170|NCT03317444|183223200|SUPERIORITY||Treatment difference in % of subjects|33.1|||<|0.0001|TWO_SIDED|95.0|19.7|45.6|||Fisher Exact|||% Subjects with Serum Bicarbonate in the Normal Range (22 - 29 mEq/L): TRC101-Placebo||45.6|19.7|< 0.0001
91665171|NCT03317444|183223201|SUPERIORITY||Treatment difference in LS means|2.63|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|1.77|3.5|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares (LS) Mean Change from Baseline: TRC101-Placebo||3.5|1.77|< 0.0001
91665172|NCT05133180|183223212|SUPERIORITY|The following null hypothesis is defined on this endpoint: the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Odds Ratio (OR)|16.946|||<|0.001|TWO_SIDED|95.0|3.412|84.165||P-value of treatment variable from logistic regression model on the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min|Regression, Logistic|||It was analyzed by means of a logistic regression model adjusting by pre-defined baseline factors (treatment, gender, age class, baseline Schirmer I test value as fixed effects and site as random effect). For the imputation of missing data at week 4, a Multiple Imputation approach is adopted by performing a regression model with the baseline Schirmer I test value, gender, age class, and Schirmer I test at week 2 as explanatory variables and generating 200 datasets.||84.165|3.412|<0.001
91665173|NCT05133180|183223213|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|adjusted mean difference|-4.561||||0.322|TWO_SIDED|95.0|-13.581|4.459||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||This endpoint was analyzed by means of an Analysis of Covariance with change from baseline in global SANDE Score at Week 12 as dependent variable, treatment, gender, age class, baseline global SANDE score as fixed effects and site as random effect. For missing data, Multiple Imputation approach is adopted by performing a regression model with the baseline global SANDE score, gender, age class, and intermediate global SANDE scores up to week 12 as explanatory variables and generating 200 datasets||4.459|-13.581|0.322
91665174|NCT05133180|183223214|SUPERIORITY|Analysis was based on a logistic regression with the number of patients reaching a value of Schirmer I test \>10mm/5min at week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|15.95|||<|0.001|TWO_SIDED|95.0|3.091|82.31|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with the number of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||82.310|3.091|<0.001
91665175|NCT05133180|183223215|SUPERIORITY||adjusted mean difference|-2.753||||0.572|TWO_SIDED|95.0|-12.303|6.798||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||6.798|-12.303|0.572
91665176|NCT05133180|183223216|SUPERIORITY||adjusted mean difference|-4.732||||0.307|TWO_SIDED|95.0|-13.819|4.354||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||4.354|-13.819|0.307
91665177|NCT05133180|183223217|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.16||||0.468|TWO_SIDED|95.0|-3.668|7.988||P-value of Least Square (LS) means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|MMRM|||Impact on daily activities at week 4.||7.988|-3.668|0.468
91665178|NCT05133180|183223217|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.431||||0.492|TWO_SIDED|95.0|-4.5|9.362||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 4.|MMRM|||Emotional Impact due to Dry eye at week 4.||9.362|-4.500|0.492
91665179|NCT05133180|183223217|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|3.3||||0.51|TWO_SIDED|95.0|-6.511|13.111||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 4.|MMRM|||Impact on Work due to Dry Eye at week 4.||13.111|-6.511|0.510
91665180|NCT05133180|183223217|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|Least square mean difference|4.078||||0.268|TWO_SIDED|95.0|-3.142|11.299||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|MMRM|||Quality of life - Impact on daily activities - Week 12||11.299|-3.142|0.268
91629783|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.32||0.823|TWO_SIDED|95.0|-2.89|2.3|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-2.89|0.823
91629784|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|1.43||0.387|TWO_SIDED|95.0|-4.04|1.57|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-4.04|0.387
91629785|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.42||0.737|TWO_SIDED|95.0|-3.25|2.3|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-3.25|0.737
91629786|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.45||0.443|TWO_SIDED|95.0|-1.73|3.97|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.97|-1.73|0.443
91629787|NCT00565812|183151816|SUPERIORITY_OR_OTHER||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.44||0.585|TWO_SIDED|95.0|-3.62|2.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.04|-3.62|0.585
91629788|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.16||0.613|TWO_SIDED|95.0|-1.68|2.85|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-1.68|0.613
91629789|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.16||0.67|TWO_SIDED|95.0|-2.76|1.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-2.76|0.670
91629790|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-1.33|STANDARD_ERROR_OF_MEAN|1.27||0.296|TWO_SIDED|95.0|-3.82|1.16|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-3.82|0.296
91629791|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|1.27||0.604|TWO_SIDED|95.0|-3.15|1.83|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.83|-3.15|0.604
91665181|NCT05133180|183223217|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall"|least square mean difference|5.55||||0.227|TWO_SIDED|95.0|-3.462|14.562||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 12.|MMRM|||Quality of life - Emotional Impact due to Dry eye - Week 12||14.562|-3.462|0.227
91714247|NCT01656395|183320226|SUPERIORITY||Mean Difference (Final Values)|0.375||||0.051|TWO_SIDED|95.0|-0.001|0.751|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.751|-0.001|0.051
91482861|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.7537|TWO_SIDED|95.0|-18.36|13.36||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||13.36|-18.36|0.7537
91665182|NCT05133180|183223217|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|3.475||||0.501|TWO_SIDED|95.0|-6.651|13.601||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 12.|MMRM|||Quality of life - Impact on Work due to Dry Eye - Week 12||13.601|-6.651|0.501
91792112|NCT03036800|183461990|SUPERIORITY||Mean Difference (Net)|-6.16|||<|0.001|TWO_SIDED|95.0|-7.03|-5.28|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.28|-7.03|<0.001
91792113|NCT03036800|183461991|SUPERIORITY||Mean Difference (Net)|-4.22|||<|0.001|TWO_SIDED|95.0|-5.56|-2.89|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.89|-5.56|<0.001
91482862|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.51||||0.1266|TWO_SIDED|95.0|-28.86|3.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.65|-28.86|0.1266
91525578|NCT00649389|182926347|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91629792|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-1.86|STANDARD_ERROR_OF_MEAN|1.33||0.163|TWO_SIDED|95.0|-4.46|0.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.75|-4.46|0.163
91629793|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.32||0.939|TWO_SIDED|95.0|-2.69|2.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-2.69|0.939
91629794|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-1.74|STANDARD_ERROR_OF_MEAN|1.46||0.233|TWO_SIDED|95.0|-4.61|1.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.12|-4.61|0.233
91629795|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.45||0.72|TWO_SIDED|95.0|-2.32|3.36|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.36|-2.32|0.720
91629796|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.45||0.993|TWO_SIDED|95.0|-2.82|2.85|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-2.82|0.993
91629797|NCT00565812|183151817|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.44||0.794|TWO_SIDED|95.0|-3.19|2.44|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-3.19|0.794
91629798|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.53||0.069|TWO_SIDED|95.0|-0.07|2.02|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|-0.07|0.069
91665183|NCT05133180|183223218|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.549||||0.924|TWO_SIDED|95.0|-11.82|10.723||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module Satisfaction with Treatment Effectiveness - week 4||10.723|-11.820|0.924
91692000|NCT03380429|183278462|OTHER||Mean Difference (Net)|0.4||||0.441|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.5|-0.7|0.441
91792114|NCT03036800|183461992|SUPERIORITY||Median Difference (Net)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.96|-5.64|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.64|-11.96|<0.001
91482863|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.96||||0.6724|TWO_SIDED|95.0|-28.34|18.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||18.41|-28.34|0.6724
91629799|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.54||0.335|TWO_SIDED|95.0|-0.53|1.57|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-0.53|0.335
91482864|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.017|TWO_SIDED|95.0|-53.89|-5.5||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||-5.50|-53.89|0.0170
91629800|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.62||0.153|TWO_SIDED|95.0|-0.33|2.11|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.11|-0.33|0.153
91629801|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.672|TWO_SIDED|95.0|-0.95|1.47|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.47|-0.95|0.672
91629802|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.63||0.765|TWO_SIDED|95.0|-1.05|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.05|0.765
91629803|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.675|TWO_SIDED|95.0|-0.96|1.49|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.96|0.675
91629804|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.72||0.56|TWO_SIDED|95.0|-1.0|1.84|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.84|-1.00|0.560
91629805|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.72||0.433|TWO_SIDED|95.0|-0.84|1.97|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-0.84|0.433
91629806|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.73||0.318|TWO_SIDED|95.0|-0.7|2.16|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|-0.70|0.318
91629807|NCT00565812|183151818|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.73||0.303|TWO_SIDED|95.0|-0.68|2.18|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.18|-0.68|0.303
91629808|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|1.67|STANDARD_ERROR_OF_MEAN|0.81||0.039|TWO_SIDED|95.0|0.08|3.26|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLGU\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.26|0.08|0.039
91665184|NCT05133180|183223218|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|1.072||||0.745|TWO_SIDED|95.0|-5.398|7.542||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 4||7.542|-5.398|0.745
91792115|NCT03036800|183461993|SUPERIORITY||Median Difference (Net)|-9.59||||0.001|TWO_SIDED|95.0|-14.91|-4.27|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.27|-14.91|0.001
91792116|NCT01986933|183461994|SUPERIORITY||Mean Difference (Final Values)|-21.39|STANDARD_ERROR_OF_MEAN|7.02||0.0027|TWO_SIDED|95.0|-35.25|-7.53||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-7.53|-35.25|0.0027
91482865|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.94||||0.3196|TWO_SIDED|95.0|-92.67|30.78||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||30.78|-92.67|0.3196
91665185|NCT05133180|183223218|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-4.206||||0.467|TWO_SIDED|95.0|-15.53|7.118||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Satisfaction with Treatment Effectiveness - week 12||7.118|-15.530|0.467
91692001|NCT03380429|183278462|OTHER||Mean Difference (Net)|0.8||||0.164|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.9|-0.3|0.164
91692002|NCT03380429|183278462|OTHER||Mean Difference (Net)|0.3||||0.661|TWO_SIDED|95.0|-0.9|1.4||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.4|-0.9|0.661
91482866|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-64.97||||0.049|TWO_SIDED|95.0|-129.64|-0.31||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.31|-129.64|0.0490
91525579|NCT00649389|182926347|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91692003|NCT03380429|183278463|OTHER||Odds Ratio (OR)|0.75||||0.385|TWO_SIDED|95.0|0.39|1.44||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.44|0.39|0.385
91692004|NCT03380429|183278463|OTHER||Odds Ratio (OR)|1.24||||0.517|TWO_SIDED|95.0|0.64|2.42||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.42|0.64|0.517
91692005|NCT03380429|183278463|OTHER||Odds Ratio (OR)|0.97||||0.921|TWO_SIDED|95.0|0.51|1.85||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.85|0.51|0.921
91692006|NCT03380429|183278463|OTHER||Odds Ratio (OR)|0.72||||0.321|TWO_SIDED|95.0|0.38|1.38||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.38|0.38|0.321
91692007|NCT03380429|183278464|OTHER||Odds Ratio (OR)|1.04||||0.911|TWO_SIDED|95.0|0.54|1.98||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.98|0.54|0.911
91692008|NCT03380429|183278464|OTHER||Odds Ratio (OR)|1.33||||0.383|TWO_SIDED|95.0|0.7|2.54||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.54|0.70|0.383
91692009|NCT03380429|183278464|OTHER||Odds Ratio (OR)|1.08||||0.814|TWO_SIDED|95.0|0.57|2.04||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.04|0.57|0.814
91692010|NCT03380429|183278464|OTHER||Odds Ratio (OR)|1.01||||0.986|TWO_SIDED|95.0|0.53|1.89||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.89|0.53|0.986
91692011|NCT03380429|183278465|OTHER||Odds Ratio (OR)|0.93||||0.833|TWO_SIDED|95.0|0.48|1.81||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.81|0.48|0.833
91665186|NCT05133180|183223218|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.244||||0.564|TWO_SIDED|95.0|-5.387|9.874||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 12||9.874|-5.387|0.564
91665187|NCT05133180|183223219|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.805||||0.802|TWO_SIDED|95.0|-7.086|5.476||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 4.|MMRM|||IDEEL - Symptom Bother module - week 4||5.476|-7.086|0.802
91665188|NCT05133180|183223219|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-8.789||||0.019|TWO_SIDED|95.0|-16.16|-1.418||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 12.|MMRM|||IDEEL - Symptom Bother module - week 12||-1.418|-16.160|0.019
91665189|NCT05133180|183223220|SUPERIORITY||least square mean difference|-1.518||||0.045|TWO_SIDED|95.0|-3.005|-0.031||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 4.|MMRM|||Herein Week 4 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.031|-3.005|0.045
91665190|NCT05133180|183223220|SUPERIORITY||least square mean difference|-1.773||||0.038|TWO_SIDED|95.0|-3.446|-0.101||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 8.|MMRM|||Herein Week 8 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.101|-3.446|0.038
91665191|NCT05133180|183223220|SUPERIORITY||least square mean difference|-1.224||||0.2|TWO_SIDED|95.0|-3.096|0.649||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 12|MMRM|||Herein Week 12 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||0.649|-3.096|0.200
91665192|NCT05133180|183223221|SUPERIORITY||least square mean difference|1.64||||0.016|TWO_SIDED|95.0|0.3|2.98||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 4.|MMRM|||Herein week 4 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.980|0.300|0.016
91665193|NCT05133180|183223221|SUPERIORITY||least ssquare mean difference|1.133||||0.129|TWO_SIDED|95.0|-0.329|2.596||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 8.|MMRM|||Herein week 8 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.596|-0.329|0.129
91665194|NCT05133180|183223221|SUPERIORITY||least square mean difference|1.36||||0.05|TWO_SIDED|95.0|-0.002|2.722||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 12.|MMRM|||Herein week 12 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.722|-0.002|0.050
91665195|NCT05133180|183223222|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 4 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||<0.001
91665196|NCT05133180|183223222|SUPERIORITY|||||||0.009||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.009
91665197|NCT05133180|183223222|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.020
91665198|NCT05133180|183223222|SUPERIORITY|||||||0.022||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.022
91525580|NCT00649389|182926347|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
91629809|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.82||0.395|TWO_SIDED|95.0|-0.91|2.3|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.91|0.395
91629810|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|0.96||0.16|TWO_SIDED|95.0|-0.54|3.25|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.25|-0.54|0.160
91629811|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.46|STANDARD_ERROR_OF_MEAN|0.97||0.638|TWO_SIDED|95.0|-1.44|2.35|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.35|-1.44|0.638
91629812|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.98||0.537|TWO_SIDED|95.0|-1.32|2.54|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.54|-1.32|0.537
91629813|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.98||0.988|TWO_SIDED|95.0|-1.9|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*(visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-1.90|0.988
91629814|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|1.11||0.962|TWO_SIDED|95.0|-2.12|2.22|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.22|-2.12|0.962
91629815|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.856|TWO_SIDED|95.0|-1.97|2.37|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-1.97|0.856
91629816|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.15||0.237|TWO_SIDED|95.0|-0.9|3.63|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.63|-0.90|0.237
91629817|NCT00565812|183151819|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.15||0.475|TWO_SIDED|95.0|-1.44|3.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.09|-1.44|0.475
91629818|NCT00565812|183151820|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.57||0.938|TWO_SIDED|95.0|-1.07|1.16|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-1.07|0.938
91629819|NCT00565812|183151820|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.56||0.906|TWO_SIDED|95.0|-1.04|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-1.04|0.906
91629820|NCT00565812|183151820|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.65||0.726|TWO_SIDED|95.0|-1.5|1.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.04|-1.50|0.726
91629821|NCT00565812|183151820|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.64||0.681|TWO_SIDED|95.0|-1.52|1.0|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.00|-1.52|0.681
91692012|NCT03380429|183278465|OTHER||Odds Ratio (OR)|1.35||||0.383|TWO_SIDED|95.0|0.69|2.67||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.67|0.69|0.383
91629822|NCT00565812|183151821|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.9|TWO_SIDED|95.0|-1.07|1.21|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.21|-1.07|0.900
91629823|NCT00565812|183151821|SUPERIORITY_OR_OTHER||LS mean difference|0.36|STANDARD_ERROR_OF_MEAN|0.58||0.528|TWO_SIDED|95.0|-0.77|1.5|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.50|-0.77|0.528
91629824|NCT00565812|183151821|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.647|TWO_SIDED|95.0|-1.51|0.94|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.94|-1.51|0.647
91629825|NCT00565812|183151821|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.62||0.841|TWO_SIDED|95.0|-1.34|1.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.09|-1.34|0.841
91629826|NCT00565812|183151822|SUPERIORITY_OR_OTHER||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.59||0.587|TWO_SIDED|95.0|-0.84|1.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.48|-0.84|0.587
91629827|NCT00565812|183151822|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.58||0.687|TWO_SIDED|95.0|-0.91|1.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-0.91|0.687
91629828|NCT00565812|183151822|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.65||0.677|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.677
91629829|NCT00565812|183151822|SUPERIORITY_OR_OTHER||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.65||0.469|TWO_SIDED|95.0|-0.8|1.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.74|-0.80|0.469
91629830|NCT00565812|183151823|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.48||0.632|TWO_SIDED|95.0|-0.71|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-0.71|0.632
91629831|NCT00565812|183151823|SUPERIORITY_OR_OTHER||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.48||0.308|TWO_SIDED|95.0|-0.45|1.42|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-0.45|0.308
91629832|NCT00565812|183151823|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.54||0.615|TWO_SIDED|95.0|-1.33|0.79|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.79|-1.33|0.615
91629833|NCT00565812|183151823|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.53||0.425|TWO_SIDED|95.0|-1.48|0.62|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.62|-1.48|0.425
91629834|NCT00565812|183151824|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.54||0.214|TWO_SIDED|95.0|-0.39|1.72|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.72|-0.39|0.214
91629835|NCT00565812|183151824|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.53||0.98|TWO_SIDED|95.0|-1.06|1.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.03|-1.06|0.980
91692013|NCT03380429|183278465|OTHER||Odds Ratio (OR)|0.85||||0.628|TWO_SIDED|95.0|0.44|1.63||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.63|0.44|0.628
91629836|NCT00565812|183151824|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.575|TWO_SIDED|95.0|-0.83|1.49|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.83|0.575
91629837|NCT00565812|183151824|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.59||0.986|TWO_SIDED|95.0|-1.16|1.14|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-1.16|0.986
91629838|NCT00565812|183151825|SUPERIORITY_OR_OTHER||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|0.61||0.03|TWO_SIDED|95.0|0.13|2.52|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.52|0.13|0.030
91629839|NCT00565812|183151825|SUPERIORITY_OR_OTHER||LS mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.6||0.48|TWO_SIDED|95.0|-0.76|1.61|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-0.76|0.480
91629840|NCT00565812|183151825|SUPERIORITY_OR_OTHER||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.67||0.132|TWO_SIDED|95.0|-0.3|2.32|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.32|-0.30|0.132
91629841|NCT00565812|183151825|SUPERIORITY_OR_OTHER||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|0.66||0.117|TWO_SIDED|95.0|-0.26|2.34|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.26|0.117
91629842|NCT00565812|183151826|SUPERIORITY_OR_OTHER||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.71||0.133|TWO_SIDED|95.0|-0.32|2.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-0.32|0.133
91629843|NCT00565812|183151826|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.7||0.524|TWO_SIDED|95.0|-0.93|1.82|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.82|-0.93|0.524
91629844|NCT00565812|183151826|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.78||0.743|TWO_SIDED|95.0|-1.27|1.78|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-1.27|0.743
91629845|NCT00565812|183151826|SUPERIORITY_OR_OTHER||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.77||0.31|TWO_SIDED|95.0|-0.73|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.73|0.310
91665199|NCT05133180|183223223|SUPERIORITY|||||||0.065||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.065
91665200|NCT05133180|183223224|SUPERIORITY|||||||0.125||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.125
91665201|NCT05133180|183223225|SUPERIORITY|||||||0.005||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.005
91629846|NCT00565812|183151827|SUPERIORITY_OR_OTHER||LS mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.62||0.058|TWO_SIDED|95.0|-0.04|2.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.38|-0.04|0.058
91629847|NCT00565812|183151827|SUPERIORITY_OR_OTHER||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.61||0.213|TWO_SIDED|95.0|-0.44|1.96|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-0.44|0.213
91665202|NCT05133180|183223225|SUPERIORITY|||||||0.116||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.116
91665203|NCT05133180|183223225|SUPERIORITY|||||||0.864||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.864
91665204|NCT05133180|183223226|SUPERIORITY|||||||0.011||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.011
91629848|NCT00565812|183151827|SUPERIORITY_OR_OTHER||LS mean difference|0.98|STANDARD_ERROR_OF_MEAN|0.67||0.143|TWO_SIDED|95.0|-0.33|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.33|0.143
91629849|NCT00565812|183151827|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.45|TWO_SIDED|95.0|-0.8|1.81|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.81|-0.80|0.450
91629850|NCT00565812|183151828|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.701|TWO_SIDED|95.0|-1.19|0.8|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.80|-1.19|0.701
91629851|NCT00565812|183151828|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.5||0.764|TWO_SIDED|95.0|-0.84|1.14|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-0.84|0.764
91629852|NCT00565812|183151828|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.57||0.228|TWO_SIDED|95.0|-1.8|0.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.43|-1.80|0.228
91629853|NCT00565812|183151828|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.56||0.514|TWO_SIDED|95.0|-1.47|0.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.74|-1.47|0.514
91629854|NCT00565812|183151829|SUPERIORITY_OR_OTHER||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.62||0.023|TWO_SIDED|95.0|0.19|2.65|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.65|0.19|0.023
91629855|NCT00565812|183151829|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.62||0.391|TWO_SIDED|95.0|-0.68|1.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.75|-0.68|0.391
91629856|NCT00565812|183151829|SUPERIORITY_OR_OTHER||LS mean difference|1.02|STANDARD_ERROR_OF_MEAN|0.69||0.142|TWO_SIDED|95.0|-0.34|2.37|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-0.34|0.142
91665205|NCT05133180|183223226|SUPERIORITY|||||||0.316||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.316
91792117|NCT01986933|183461994|SUPERIORITY||Mean Difference (Final Values)|-41.16|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-55.17|-27.15||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-27.15|-55.17|<0.0001
91629857|NCT00565812|183151829|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.68||0.204|TWO_SIDED|95.0|-0.47|2.21|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-0.47|0.204
91629858|NCT00565812|183151836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.952||||0.875|TWO_SIDED|95.0|0.516|1.756|||Regression, Logistic|||Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.756|0.516|0.875
91629859|NCT00565812|183151836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.273||||0.406|TWO_SIDED|95.0|0.721|2.247|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.247|0.721|0.406
91629860|NCT00565812|183151836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.787||||0.406|TWO_SIDED|95.0|0.448|1.384|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.384|0.448|0.406
91629861|NCT00565812|183151836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.154||||0.591|TWO_SIDED|95.0|0.685|1.942|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.942|0.685|0.591
91629862|NCT00565812|183151837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.704||||0.168|TWO_SIDED|95.0|0.428|1.16|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.160|0.428|0.168
91629863|NCT00565812|183151837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||0.634|TWO_SIDED|95.0|0.56|1.423|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.423|0.560|0.634
91629864|NCT00565812|183151837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.583||||0.032|TWO_SIDED|95.0|0.356|0.955|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.955|0.356|0.032
91629865|NCT00565812|183151837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.276|TWO_SIDED|95.0|0.489|1.227|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.227|0.489|0.276
91629866|NCT00565812|183151838|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.709|TWO_SIDED|95.0|-0.21|0.14|||ANCOVA|||LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.14|-0.21|0.709
91629867|NCT00565812|183151838|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.798|TWO_SIDED|95.0|-0.15|0.2|||ANCOVA|||LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.20|-0.15|0.798
91629868|NCT00565812|183151839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.81|TWO_SIDED|95.0|0.797|1.337|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.337|0.797|0.810
91629869|NCT00565812|183151839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.068||||0.62|TWO_SIDED|95.0|0.824|1.383|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.383|0.824|0.620
91629870|NCT00565812|183151840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.745||||0.047|TWO_SIDED|95.0|0.557|0.997|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.997|0.557|0.047
91629871|NCT00565812|183151840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.864||||0.317|TWO_SIDED|95.0|0.65|1.15|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.150|0.650|0.317
91629872|NCT00565812|183151841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.043||||0.881|TWO_SIDED|95.0|0.602|1.806|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.806|0.602|0.881
91629873|NCT00565812|183151841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.186||||0.525|TWO_SIDED|95.0|0.701|2.009|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.009|0.701|0.525
91629874|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.63||0.668|TWO_SIDED|95.0|-1.5|0.96|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.96|-1.50|0.668
91629875|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.63||0.326|TWO_SIDED|95.0|-0.61|1.85|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.85|-0.61|0.326
91629876|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.66||0.679|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.679
91629877|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.66||0.005|TWO_SIDED|95.0|0.57|3.14|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.14|0.57|0.005
91629878|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.399|TWO_SIDED|95.0|-0.8|2.01|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-0.80|0.399
91629879|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|2.52|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.12|3.92|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.92|1.12|<0.001
91629880|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.08|1.68|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.08|0.668
91629881|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.7||0.012|TWO_SIDED|95.0|0.39|3.13|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.13|0.39|0.012
91629882|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.75||0.109|TWO_SIDED|95.0|-0.27|2.67|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.67|-0.27|0.109
91629883|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|0.74||0.163|TWO_SIDED|95.0|-0.42|2.48|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-0.42|0.163
91665206|NCT05133180|183223226|SUPERIORITY|||||||0.685||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.685
91665207|NCT05133180|183223227|SUPERIORITY|||||||0.016||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.016
91665208|NCT05133180|183223227|SUPERIORITY|||||||0.16||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.160
91665209|NCT05133180|183223227|SUPERIORITY|||||||0.839||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.839
91629884|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.73||0.424|TWO_SIDED|95.0|-2.02|0.85|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.85|-2.02|0.424
91665210|NCT05133180|183223228|SUPERIORITY|||||||0.0455|||||||Chi-squared|||||||0.0455
91665211|NCT05133180|183223229|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.06||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 8||||0.060
91665212|NCT05133180|183223229|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.079||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 8||||0.079
91665213|NCT05133180|183223229|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.251||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 8||||0.251
91792118|NCT01986933|183461994|SUPERIORITY||Mean Difference (Final Values)|-40.39|STANDARD_ERROR_OF_MEAN|6.95|<|0.0001|TWO_SIDED|95.0|-54.11|-26.67||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-26.67|-54.11|<0.0001
91629885|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.72||0.635|TWO_SIDED|95.0|-1.07|1.76|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.07|0.635
91629886|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.75||0.855|TWO_SIDED|95.0|-1.34|1.61|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-1.34|0.855
91665214|NCT05133180|183223229|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.203||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 16||||0.203
91665215|NCT05133180|183223229|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.114||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 16||||0.114
91665216|NCT05133180|183223229|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.112||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 16||||0.112
91665217|NCT05133180|183223230|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.002||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 8||||0.002
91665218|NCT05133180|183223230|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 16||||0.076
91665219|NCT05133180|183223231|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.16||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 8||||0.160
91629887|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|0.74||0.013|TWO_SIDED|95.0|0.38|3.3|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|0.38|0.013
91629888|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.81||0.292|TWO_SIDED|95.0|-2.44|0.73|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.73|-2.44|0.292
91665220|NCT05133180|183223231|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.009||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 8||||0.009
91665221|NCT05133180|183223231|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 16||||0.076
91665222|NCT05133180|183223231|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.128||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 16||||0.128
91665223|NCT04723693|183223235|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
91665224|NCT04723693|183223236|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
91665225|NCT04188392|183223245|OTHER|Rate of subjects enrolled per month of recruitment; based on 6 subjects enrolled over 5.8 months of recruitment.|Rate (per month)|1.03|||||TWO_SIDED|95.0|0.38|2.25|||||Based on 6 subjects enrolled over 5.8 months of recruitment|Recruitment goal of 6 subjects total.||2.25|0.38|
91665226|NCT04188392|183223246|OTHER|Total participants = 6; completed protocol: yes = 6, no = 0|Point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate = 100% (95% C.I. 54%,100%)|Binary outcome (completed protocol yes vs. no); goal of 75% of subjects completing protocol|Point estimate of completion rate and 95% confidence interval|1|0.54|
91665227|NCT04188392|183223247|OTHER|paired t-test|Mean of the differences|21.7||||0.2873|TWO_SIDED|95.0|-27.4|70.8||A priori significance threshold of p\<0.05|t-test, 2 sided|t=1.2263, df=4||alternative hypothesis: true difference in means is not equal to 0||70.8|-27.4|0.2873
91665228|NCT04188392|183223248|OTHER|Total participants = 6; discontinued due to adverse effects: yes = 0, no =6|Point estimate, 95% confidence interval|0.0|||||TWO_SIDED|95.0|0.0|0.46|||||Discontinuation rates due to adverse effects: Point estimate 0% (95% C.I. 0%, 45.9%)|Binary outcome: Discontinued due to adverse effects yes vs. no||0.46|0|
91665229|NCT04188392|183223249|OTHER|Total participants = 6; completed sleep study 1: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 1 = 100% (95% C.I. 54%, 100%)|Binary outcome: Completed sleep study 1 yes vs. no||1|0.54|
91665230|NCT04188392|183223249|OTHER|Total participants = 6; completed sleep study 2: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 2 = 100% (95% C.I. 54%, 100%)|Binary outcome: completed sleep study 2 yes vs. no||1|0.54|
91665231|NCT04188392|183223249|OTHER|Total participants = 6; completed sleep study 3: yes = 5, no=1|point estimate|0.83|||||TWO_SIDED|95.0|0.36|0.996|||||Point estimate of completion rate for sleep study 3 = 83.3% (95% C.I. 36%, 99.6%)|Binary outcome: completed sleep study 3 yes vs. no||0.996|0.36|
91665232|NCT04188392|183223249|OTHER|Total participants = 6; at least 4 days of actigraphy data: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for at least 4 days of actigraphy pre-treatment = 100% (95% C.I. 54%, 100%).|Binary outcome: at least 4 days of actigraphy data pre-treatment yes vs. no||1|0.54|
91665233|NCT04188392|183223249|OTHER|Total participants = 6; at least 4 days of actigraphy post-treatment: yes = 6, no =0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of actigraphy post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of actigraphy post-treatment yes vs. no||1|0.54|
91665234|NCT04188392|183223249|OTHER|Total participants = 6; at least 4 days of sleep diary pre-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary pre-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary pre-treatment yes vs. no||1|0.54|
91665235|NCT04188392|183223249|OTHER|Total participants = 6; at least 4 days of sleep diary post-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary post-treatment yes vs. no||1|0.54|
91665236|NCT01906372|183223290|SUPERIORITY_OR_OTHER||Frequency of achieving primary endpoint|0.7|||||TWO_SIDED|||||Open label single arm pilot trial without control group.||||||||
91665237|NCT01906372|183223291|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91665238|NCT03629054|183223292|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R).|Adjusted gMean ratio|100.42|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|90.0|98.17|102.72|||ANOVA||gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV).|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||102.72|98.17|<0.0001
91665239|NCT03629054|183223293|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.34|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|91.58|99.24|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.24|91.58|<0.0001
91665240|NCT03629054|183223294|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.16|STANDARD_ERROR_OF_MEAN|8.6|<|0.0001|TWO_SIDED|90.0|96.17|104.31|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||104.31|96.17|<0.0001
91665241|NCT03629054|183223295|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|92.57|STANDARD_ERROR_OF_MEAN|17.9||0.0029|TWO_SIDED|90.0|85.21|100.57|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||100.57|85.21|0.0029
91665242|NCT03629054|183223296|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|97.33|STANDARD_ERROR_OF_MEAN|16.9||0.0001|TWO_SIDED|90.0|89.99|105.26|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||105.26|89.99|0.0001
91525581|NCT02608489|182926360|SUPERIORITY_OR_OTHER|||||||0.221|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.221
91665243|NCT03629054|183223297|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|104.83|STANDARD_ERROR_OF_MEAN|13.2|<|0.0001|TWO_SIDED|90.0|98.56|111.5|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||111.50|98.56|<0.0001
91665244|NCT03629054|183223298|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.73|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|90.0|98.33|103.18|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||103.18|98.33|<0.0001
91629889|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.897|TWO_SIDED|95.0|-1.47|1.68|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.47|0.897
91629890|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.84||0.39|TWO_SIDED|95.0|-2.36|0.92|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.92|-2.36|0.390
91629891|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.83||0.659|TWO_SIDED|95.0|-1.26|1.99|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.99|-1.26|0.659
91629892|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.8||0.847|TWO_SIDED|95.0|-1.73|1.42|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-1.73|0.847
91629893|NCT00565812|183151845|SUPERIORITY_OR_OTHER||LS mean difference|0.77|STANDARD_ERROR_OF_MEAN|0.8||0.333|TWO_SIDED|95.0|-0.79|2.34|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.79|0.333
91629894|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.238|TWO_SIDED|95.0|-1.31|0.32|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.31|0.238
91629895|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.815|TWO_SIDED|95.0|-0.72|0.91|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.91|-0.72|0.815
91629896|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.42||0.508|TWO_SIDED|95.0|-0.54|1.1|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.10|-0.54|0.508
91629897|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|0.38|2.02|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|0.38|0.004
91629898|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.683|TWO_SIDED|95.0|-1.07|0.7|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.70|-1.07|0.683
91629899|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.45||0.007|TWO_SIDED|95.0|0.33|2.09|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|0.33|0.007
91629900|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.45||0.687|TWO_SIDED|95.0|-0.71|1.07|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.07|-0.71|0.687
91665245|NCT03629054|183223299|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|103.57|STANDARD_ERROR_OF_MEAN|14.3|<|0.0001|TWO_SIDED|90.0|96.9|110.71|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||110.71|96.90|<0.0001
91525582|NCT02608489|182926360|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.015
91665246|NCT03629054|183223300|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.74|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|90.0|92.29|99.32|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.32|92.29|<0.0001
91629901|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.45||0.05|TWO_SIDED|95.0|0.0|1.78|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-0.00|0.050
91525583|NCT02608489|182926361|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.256
91629902|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.54|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-0.35|0.215
91629903|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.47||0.042|TWO_SIDED|95.0|0.03|1.89|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.89|0.03|0.042
91629904|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.5||0.401|TWO_SIDED|95.0|-1.41|0.56|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.41|0.401
91629905|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.98|TWO_SIDED|95.0|-0.96|0.99|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.99|-0.96|0.980
91629906|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.76|-1.25|0.632
91629907|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|0.51||0.032|TWO_SIDED|95.0|0.09|2.07|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.07|0.09|0.032
91629908|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.54||0.668|TWO_SIDED|95.0|-1.29|0.83|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-1.29|0.668
91629909|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.038|TWO_SIDED|95.0|0.06|2.16|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|0.06|0.038
91629910|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.53||0.868|TWO_SIDED|95.0|-1.13|0.95|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.95|-1.13|0.868
91629911|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.257|TWO_SIDED|95.0|-0.43|1.62|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.62|-0.43|0.257
91629912|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|95.0|-1.0|1.15|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.15|-1.00|0.895
91629913|NCT00565812|183151846|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.54||0.268|TWO_SIDED|95.0|-0.46|1.67|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.67|-0.46|0.268
91525584|NCT02608489|182926361|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.||||0.025
91629914|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.908|TWO_SIDED|95.0|-0.92|0.82|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.82|-0.92|0.908
91629915|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.44||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.31|-2.05|0.008
91629916|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.46||0.44|TWO_SIDED|95.0|-1.25|0.54|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.54|-1.25|0.440
91629917|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.46||0.14|TWO_SIDED|95.0|-1.57|0.22|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.22|-1.57|0.140
91629918|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.46||0.474|TWO_SIDED|95.0|-0.58|1.24|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.24|-0.58|0.474
91665247|NCT00924638|183223315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.4||||0.0006|TWO_SIDED|95.0|1.9|21.7|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||21.7|1.9|0.0006
91665248|NCT00924638|183223316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.3|||<|0.0001|TWO_SIDED|95.0|2.6|20.8|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||20.8|2.6|<0.0001
91665249|NCT00924638|183223317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.32|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.|||1.32|0.35|0.25
91665250|NCT00924638|183223318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|||||TWO_SIDED|95.0|2.8|14.8|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.|||14.8|2.8|
91665251|NCT00924638|183223319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.3|3.1|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.|||3.1|-2.3|
91665252|NCT00924638|183223320|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.11
91665253|NCT00924638|183223321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.33|TWO_SIDED|95.0|0.73|2.6|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.|||2.60|0.73|0.33
91665254|NCT02679729|183223328|SUPERIORITY_OR_OTHER||Slope|0.625|||||TWO_SIDED|95.0|0.396|0.853||||||Statistical Analysis for Part A||0.853|0.396|
91665255|NCT02679729|183223329|SUPERIORITY_OR_OTHER||Slope|1.2|||||TWO_SIDED|95.0|0.905|1.49||||||Statistical Analysis for Part A||1.49|0.905|
91665256|NCT02679729|183223330|SUPERIORITY_OR_OTHER||Slope|1.55|||||TWO_SIDED|95.0|1.34|1.76||||||Statistical Analysis for Part A||1.76|1.34|
91665257|NCT00989950|183223369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|14.0||0.588|TWO_SIDED|95.0|0.0|233.0|||ANOVA|||||233|0|0.588
91665258|NCT01124786|183223370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994|||<|0.973|TWO_SIDED|95.0|0.746|1.326|||Log Rank||Hazard ratio and confidence interval presented above, so parameter dispersion not indicated in standard deviation field directly above.|If the median Overall Survival (OS) for the CO-1.01-treated patients is 7.7 months and the median OS for gemcitabine-treated patients with hENT1-low status is 4 months (hazard ratio of 0.53), then a total of 144 events of death in the hENT1-low subgroup will provide over 90% power at a 0.05 (2 sided) significance level for the comparison of CO-1.01 to gemcitabine in the hENT1-low patients.||1.326|0.746|<0.973
91665259|NCT03488108|183223399|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
91665260|NCT03488108|183223400|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.90
91665261|NCT03488108|183223401|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
91665262|NCT03488108|183223402|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||.005
91665263|NCT01665508|183223408|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were reported as the mean ± (SD) and categorical data presented as frequency and percentage of the sample. Comparisons between baseline and post-treatment SAQ scores, SF-36v2 scores, and CPET variables were performed using a paired t-test for normally distributed variables or a Wilcoxon signed-rank test for non-normally distributed variables. Normality was defined by the Shapiro-Wilk test. For categorical variables, data were compared using a chi-squared test.||||< 0.05
91665264|NCT02054715|183223412|OTHER||Mean Difference (MP - PE)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.9621|TWO_SIDED|95.0|-4.1|3.9|||F-Test|||Two-sided F-Test as a statistical comparing MP and PE means.||3.9|-4.1|0.9621
91665265|NCT02054715|183223413|OTHER||Mean Difference (MP - PE)|0.18|STANDARD_ERROR_OF_MEAN|1.57||0.9065|TWO_SIDED|95.0|-2.89|3.26|||F-test|||Two-sided F-Test comparing the MP and PE means.||3.26|-2.89|0.9065
91665266|NCT02054715|183223414|OTHER||Mean Difference (MP - PE)|-0.05|STANDARD_ERROR_OF_MEAN|1.4||0.9709|TWO_SIDED|95.0|-2.79|2.69|||F-Test|||Two-sided F-Test comparing the MP and PE means.||2.69|-2.79|0.9709
91629919|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.46||0.376|TWO_SIDED|95.0|-1.32|0.5|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.50|-1.32|0.376
91629920|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.5||0.186|TWO_SIDED|95.0|-0.32|1.64|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-0.32|0.186
91629921|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.5||0.185|TWO_SIDED|95.0|-1.63|0.32|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.63|0.185
91629922|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.52||0.334|TWO_SIDED|95.0|-1.53|0.52|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-1.53|0.334
91629923|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.055|TWO_SIDED|95.0|-2.0|0.02|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.02|-2.00|0.055
91629924|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.54||0.539|TWO_SIDED|95.0|-1.38|0.72|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.72|-1.38|0.539
91629925|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|-2.3|-0.22|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.22|-2.30|0.018
91629926|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.53||0.365|TWO_SIDED|95.0|-1.52|0.56|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.52|0.365
91629927|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.403|TWO_SIDED|95.0|-1.47|0.59|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.59|-1.47|0.403
91629928|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.57||0.02|TWO_SIDED|95.0|-2.43|-0.21|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.21|-2.43|0.020
91665267|NCT02054715|183223415|OTHER|||||||0.014|||||||Chi-squared|||Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education group||||0.014
91665268|NCT01442376|183223417|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|0.36|||||TWO_SIDED|97.5|-11.7|12.4||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||12.4|-11.7|
91665269|NCT01442376|183223417|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|-4.4|||||TWO_SIDED|97.5|-16.4|7.6||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||7.6|-16.4|
91525585|NCT02608489|182926362|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.080
91792119|NCT01077154|183462003|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7|TWO_SIDED|95.0|0.82|1.14|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.14|0.82|0.70
91525586|NCT02608489|182926362|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.021
91629929|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-2.98|-0.77|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.77|-2.98|<0.001
91629930|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.269|TWO_SIDED|95.0|-1.66|0.46|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-1.66|0.269
91629931|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.54||0.104|TWO_SIDED|95.0|-1.92|0.18|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-1.92|0.104
91629932|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.57||0.038|TWO_SIDED|95.0|-2.3|-0.06|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.06|-2.30|0.038
91629933|NCT00565812|183151847|SUPERIORITY_OR_OTHER||LS mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.28|-0.05|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.05|-2.28|0.041
91629934|NCT02896192|183151865|OTHER||CI||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
91629935|NCT02896192|183151866|OTHER||||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
91629936|NCT02896192|183151867|OTHER||Least Squares Mean|-25.73|||<|0.0001|TWO_SIDED|90.0|-28.49|-22.98|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.||-22.98|-28.49|<0.0001
91629937|NCT02896192|183151868|OTHER||Least Squares Mean|-27.77||||0.0005|TWO_SIDED|90.0|-40.58|-14.96|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.||-14.96|-40.58|0.0005
91629938|NCT02896192|183151869|OTHER|||||||0.0004||||||One-sided p-value obtained from exact binomial test, testing that ≥ 5% of participants in the population of interest would achieve ≥ 25% improvement in daily hunger score.|Exact binomial test|||||||0.0004
91629939|NCT02896192|183151870|OTHER||Least Squares Mean|-18.1|||<|0.0001|TWO_SIDED|90.0|-21.27|-14.88|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.||-14.88|-21.27|<0.0001
91629940|NCT02896192|183151873|OTHER||Least Squares Mean|-27.4|||<|0.0001|TWO_SIDED|90.0|-30.6|-24.29|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.||-24.29|-30.60|<0.0001
91629941|NCT04857892|183151918|OTHER||Ratio of geometric Least Square mean|1.025|||||TWO_SIDED|90.0|0.9335|1.126|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.126|0.9335|
91629942|NCT04857892|183151918|OTHER||Ratio of geometric Least Square mean|1.072|||||TWO_SIDED|90.0|0.9693|1.185|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.185|0.9693|
91629943|NCT04857892|183151919|OTHER||Ratio of geometric Least Square mean|1.126|||||TWO_SIDED|90.0|0.9918|1.278|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.278|0.9918|
91629944|NCT04857892|183151919|OTHER||Ratio of geometric Least Square mean|1.055|||||TWO_SIDED|90.0|0.9278|1.201|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.201|0.9278|
91629945|NCT04857892|183151920|OTHER||Ratio of geometric Least Square mean|1.036|||||TWO_SIDED|90.0|0.9209|1.166|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.166|0.9209|
91792120|NCT01077154|183462004|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.57|TWO_SIDED|95.0|0.91|1.19|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hzard ratio \< 1 favors denosumab.|||1.19|0.91|0.57
91665270|NCT01075516|183223420|OTHER|Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91665271|NCT01075516|183223421|OTHER|Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91665272|NCT01075516|183223422|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.8||||||Comparison of utility at baseline from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EuroQoL Group 5-Dimension 3-Level Self-Report (EQ-5D-3L) questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.80
91665273|NCT01075516|183223422|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.38||||||Comparison of utility at 12 months from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.38
91665274|NCT01075516|183223422|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.53|||||||t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.53
91665275|NCT02252016|183223424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|23.3||||||The estimated difference (± 95% confidence interval \[CI\]) in percentage of participants experiencing an AE in the Immediate versus Deferred arms was determined.||23.3|-7.3|
91665276|NCT02252016|183223425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.155|TWO_SIDED|95.0|-10.2|1.6|||Miettinen & Nurminen method|||The estimated difference (± 95% CI) in percentage of participants withdrawing from study treatment due to an AE(s) in the Immediate versus Deferred arms was determined.||1.6|-10.2|0.155
91665277|NCT00834873|183223506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.77||||||90.0|85.04|105.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.61|85.04|
91665278|NCT00834873|183223507|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.59|102.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.23|90.59|
91482867|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.2969|TWO_SIDED|95.0|-14.7|46.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||46.79|-14.70|0.2969
91482868|NCT01227564|182839163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2||||0.0973|TWO_SIDED|95.0|-57.42|5.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||5.03|-57.42|0.0973
91665279|NCT00834873|183223508|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.11||||||90.0|90.45|102.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.12|90.45|
91665280|NCT03966911|183223512|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.0|||<|0.041|TWO_SIDED|91.8|86.05|89.95|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.95|86.05|<0.041
91665281|NCT03966911|183223512|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.96|||<|0.041|TWO_SIDED|91.8|86.13|89.8|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.80|86.13|<0.041
91665282|NCT03966911|183223512|SUPERIORITY||Intercept from ANCOVA as agreement rate|84.59||||0.041|TWO_SIDED|91.8|82.02|87.17|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||87.17|82.02|0.041
91665283|NCT03966911|183223512|SUPERIORITY||Intercept from ANCOVA as agreement rate|81.05|||<|0.041|TWO_SIDED|91.8|77.58|84.53|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||84.53|77.58|<0.041
91665284|NCT00985751|183223513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
91665285|NCT00985751|183223514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
91665286|NCT00926887|183223554|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91665287|NCT00926887|183223557|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|t=-2.711; df=102; p\<0.01||||||<0.01
91665288|NCT00926887|183223561|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|df=102, t=-3.44||||||<0.001
91665289|NCT01251393|183223584|EQUIVALENCE|"The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.~We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."|||||<|0.05||||||We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.|ANOVA|||We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.||||<0.05
91665290|NCT01541215|183223585|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: change from baseline to week 26 in HbA1c~Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%."|Treatment difference|-1.058|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.653|-0.464|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.464|-1.653|<0.001
91665291|NCT01541215|183223586|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Change from baseline in FPG after 26 weeks of treatment"|Treatment difference|-1.878|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-3.093|-0.662|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.662|-3.093|0.002
91665292|NCT01541215|183223587|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: HbA1c \< 7.0% after 26 weeks of treatment"|Treatment odds ratio|5.353|||<|0.001|TWO_SIDED|95.0|2.105|13.615|||logistic regression model|||Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.||13.615|2.105|<0.001
91665293|NCT01541215|183223588|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Change from baseline in BMI SDS after 26 weeks of treatment"|Treatment difference|-0.047|STANDARD_ERROR_OF_MEAN|0.055||0.392|TWO_SIDED|95.0|-0.153|0.06|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||0.060|-0.153|0.392
91482869|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.6653|TWO_SIDED|95.0|-7.94|5.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||5.10|-7.94|0.6653
91482870|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.4613|TWO_SIDED|95.0|-4.2|9.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||9.15|-4.20|0.4613
91482871|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.771|TWO_SIDED|95.0|-4.18|5.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||5.61|-4.18|0.7710
91629946|NCT04857892|183151920|OTHER||Ratio of geometric Least Square mean|1.02|||||TWO_SIDED|90.0|0.9049|1.151|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.151|0.9049|
91629947|NCT04857892|183151921|OTHER||Ratio of geometric Least Square mean|1.129|||||TWO_SIDED|90.0|1.067|1.195|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.195|1.067|
91629948|NCT04857892|183151921|OTHER||Ratio of geometric Least Square mean|1.112|||||TWO_SIDED|90.0|1.05|1.178|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.178|1.050|
91629949|NCT04857892|183151922|OTHER||Ratio of geometric Least Square mean|1.164|||||TWO_SIDED|90.0|1.07|1.267|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.267|1.070|
91629950|NCT04857892|183151922|OTHER||Ratio of geometric Least Square mean|1.087|||||TWO_SIDED|90.0|0.9975|1.184|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.184|0.9975|
91665294|NCT03234907|183223685|SUPERIORITY||Risk Difference (RD)|-5.2|||=|0.347|TWO_SIDED|95.0|-17.2|6.8||P-value was based on CHW test, based on weighted CMH chi-square test, with stratification according to: (1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cui-Hung-Wang (CHW) test||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.8|-17.2|=0.347
91692014|NCT03380429|183278465|OTHER||Odds Ratio (OR)|0.94||||0.844|TWO_SIDED|95.0|0.49|1.8||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.80|0.49|0.844
91629951|NCT04857892|183151923|OTHER||Ratio of geometric Least Square mean|1.078|||||TWO_SIDED|90.0|1.036|1.122|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.122|1.036|
91629952|NCT04857892|183151923|OTHER||Ratio of geometric Least Square mean|1.032|||||TWO_SIDED|90.0|0.9914|1.075|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.075|0.9914|
91629953|NCT04857892|183151924|OTHER||Ratio of geometric Least Square mean|2.705|||||TWO_SIDED|90.0|2.135|3.427|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||3.427|2.135|
91629954|NCT04857892|183151925|OTHER||Ratio of geometric Least Square mean|2.761|||||TWO_SIDED|90.0|2.16|3.527|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||3.527|2.160|
91629955|NCT04857892|183151926|OTHER||Ratio of geometric Least Square mean|2.498|||||TWO_SIDED|90.0|1.821|3.425|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||3.425|1.821|
91629956|NCT04857892|183151927|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.451|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||1.451|1.193|
91629957|NCT04857892|183151928|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.452|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||1.452|1.193|
91629958|NCT04857892|183151929|OTHER||Ratio of geometric Least Square mean|1.232|||||TWO_SIDED|90.0|1.138|1.333|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.333|1.138|
91525587|NCT02608489|182926363|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||<0.001
91629959|NCT00655811|183152036|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way anova was used to compare the mean COVAS values between groups.||||<0.05
91629960|NCT00655811|183152036|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.550
91629961|NCT00655811|183152036|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
91629962|NCT00655811|183152036|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
91629963|NCT00655811|183152037|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
91629964|NCT00655811|183152037|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91629965|NCT00655811|183152037|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
91629966|NCT00655811|183152038|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91629967|NCT04984876|183152089|OTHER||Odds Ratio (OR)|25.83||||0.002|TWO_SIDED|95.0|4.34|506.78|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||506.78|4.34|0.002
91629968|NCT04984876|183152089|OTHER||Odds Ratio (OR)|5.1||||0.073|TWO_SIDED|95.0|0.8|100.98|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||100.98|0.80|0.073
91629969|NCT04984876|183152090|OTHER||Odds Ratio (OR)|9.86||||0.018|TWO_SIDED|95.0|1.69|188.85|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||188.85|1.69|0.018
91629970|NCT04984876|183152090|OTHER||Odds Ratio (OR)|3.02||||0.164|TWO_SIDED|95.0|0.45|59.93|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||59.93|0.45|0.164
91629971|NCT04984876|183152091|OTHER||Odds Ratio (OR)|3.47||||0.138|TWO_SIDED|95.0|0.51|70.08|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||70.08|0.51|0.138
91629972|NCT04984876|183152091|OTHER||Odds Ratio (OR)|2.21||||0.247|TWO_SIDED|95.0|0.3|45.56|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||45.56|0.30|0.247
91665295|NCT03234907|183223686|SUPERIORITY||Risk Difference (RD)|-2.7|||=|0.531|TWO_SIDED|95.0|-11.5|6.0||P-value based on Cochran-Mantel-Haenszel, weighted CMH chi-square test, with stratification according to:(1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.0|-11.5|=0.531
91665296|NCT01472432|183223687|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
91665297|NCT01472432|183223688|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
91665298|NCT01472432|183223689|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P\< 0.05 versus control patients. P \< 0.05 versus baseline.|t-test, 2 sided|||p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.||||<0.05
91665299|NCT01472432|183223690|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\< 0.05 versus control patients. P \< 0.05 versus baseline|t-test, 2 sided|||||||<0.05
91665300|NCT02986139|183223693|SUPERIORITY||LS Mean Difference|-4.0||||0.048|TWO_SIDED|95.0|-8.0|0.0|||Mixed effects analysis of variance model|||A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.||-0.0|-8.0|0.048
91665301|NCT02583048|183223696|SUPERIORITY||Mean Difference (Net)|8.4|||||TWO_SIDED|95.1|2.0|14.8|||||Arm 3 minus Arm 1 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||14.8|2.0|
91629973|NCT04984876|183152092|OTHER||Odds Ratio (OR)|10.59|||<|0.001|TWO_SIDED|95.0|3.63|31.56|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||31.56|3.63|<0.001
91629974|NCT04984876|183152092|OTHER||Odds Ratio (OR)|5.05||||0.001|TWO_SIDED|95.0|1.8|14.36|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||14.36|1.80|0.001
91629975|NCT04984876|183152093|OTHER||Odds Ratio (OR)|4.73||||0.082|TWO_SIDED|95.0|0.74|93.16|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||93.16|0.74|0.082
91629976|NCT04984876|183152093|OTHER||Odds Ratio (OR)|0.61||||0.632|TWO_SIDED|95.0|0.02|16.43|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||16.43|0.02|0.632
91629977|NCT04984876|183152098|OTHER||LS Mean difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.15|-2.4|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.40|-5.15|<0.001
91629978|NCT04984876|183152098|OTHER||LS Mean difference|-4.93|||<|0.001|TWO_SIDED|95.0|-7.77|-2.09|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.09|-7.77|<0.001
91629979|NCT04984876|183152098|OTHER||LS Mean difference|-3.2||||0.015|TWO_SIDED|95.0|-6.08|-0.32|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-0.32|-6.08|0.015
91629980|NCT04984876|183152098|OTHER||LS Mean difference|-1.68||||0.13|TWO_SIDED|95.0|-4.62|1.25|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||1.25|-4.62|0.130
91629981|NCT04984876|183152099|OTHER||LS Mean difference|-0.33||||0.173|TWO_SIDED|95.0|-1.03|0.36|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.36|-1.03|0.173
91629982|NCT04984876|183152099|OTHER||LS Mean difference|-0.29||||0.202|TWO_SIDED|95.0|-0.96|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.39|-0.96|0.202
91629983|NCT04984876|183152099|OTHER||LS Mean difference|-0.37||||0.151|TWO_SIDED|95.0|-1.09|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.34|-1.09|0.151
91629984|NCT04984876|183152099|OTHER||LS Mean difference|-0.23||||0.264|TWO_SIDED|95.0|-0.94|0.49|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.49|-0.94|0.264
91629985|NCT04984876|183152099|OTHER||LS Mean difference|-0.43||||0.123|TWO_SIDED|95.0|-1.16|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.30|-1.16|0.123
91629986|NCT04984876|183152099|OTHER||LS Mean difference|-0.23||||0.258|TWO_SIDED|95.0|-0.94|0.47|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.47|-0.94|0.258
91629987|NCT04984876|183152099|OTHER||LS Mean difference|-0.17||||0.324|TWO_SIDED|95.0|-0.92|0.58|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.58|-0.92|0.324
91629988|NCT04984876|183152099|OTHER||LS Mean difference|-0.03||||0.473|TWO_SIDED|95.0|-0.78|0.73|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.73|-0.78|0.473
91629989|NCT04984876|183152100|OTHER||LS Mean difference|0.06||||0.597|TWO_SIDED|95.0|-0.44|0.57|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.57|-0.44|0.597
91629990|NCT04984876|183152100|OTHER||LS Mean difference|-0.39||||0.064|TWO_SIDED|95.0|-0.89|0.11|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.11|-0.89|0.064
91629991|NCT04984876|183152100|OTHER||LS Mean difference|-0.22||||0.191|TWO_SIDED|95.0|-0.72|0.28|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.28|-0.72|0.191
91629992|NCT04984876|183152100|OTHER||LS Mean difference|-0.02||||0.472|TWO_SIDED|95.0|-0.51|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.48|-0.51|0.472
91629993|NCT04984876|183152100|OTHER||LS Mean difference|0.03||||0.537|TWO_SIDED|95.0|-0.57|0.62|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.62|-0.57|0.537
91629994|NCT04984876|183152100|OTHER||LS Mean difference|-0.32||||0.141|TWO_SIDED|95.0|-0.91|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.27|-0.91|0.141
91629995|NCT04984876|183152100|OTHER||LS Meand difference|-0.45||||0.063|TWO_SIDED|95.0|-1.04|0.13|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.13|-1.04|0.063
91629996|NCT04984876|183152100|OTHER||LS Mean difference|-0.1||||0.368|TWO_SIDED|95.0|-0.68|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.48|-0.68|0.368
91629997|NCT04984876|183152101|OTHER||LS Mean difference|-0.24||||0.225|TWO_SIDED|95.0|-0.87|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.39|-0.87|0.225
91482872|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.02||||0.2328|TWO_SIDED|95.0|-1.99|8.04||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||8.04|-1.99|0.2328
91482873|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3693|TWO_SIDED|95.0|-0.97|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.58|-0.97|0.3693
91482874|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.422|TWO_SIDED|95.0|-1.09|2.56||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.56|-1.09|0.4220
91525588|NCT02608489|182926363|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||<0.001
91629998|NCT04984876|183152101|OTHER||LS Mean difference|-0.32||||0.153|TWO_SIDED|95.0|-0.93|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.30|-0.93|0.153
91629999|NCT04984876|183152101|OTHER||LS Mean difference|-0.3||||0.179|TWO_SIDED|95.0|-0.95|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.34|-0.95|0.179
91630000|NCT04984876|183152101|OTHER||LS Mean difference|0.11||||0.631|TWO_SIDED|95.0|-0.55|0.77|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.77|-0.55|0.631
91630001|NCT04984876|183152101|OTHER||LS Mean difference|-0.52||||0.06|TWO_SIDED|95.0|-1.18|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-1.18|0.060
91630002|NCT04984876|183152101|OTHER||LS Mean difference|-0.08||||0.404|TWO_SIDED|95.0|-0.72|0.56|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.56|-0.72|0.404
91630003|NCT04984876|183152101|OTHER||LS Mean difference|-0.38||||0.135|TWO_SIDED|95.0|-1.06|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.30|-1.06|0.135
91630004|NCT04984876|183152101|OTHER||LS Mean difference|0.01||||0.514|TWO_SIDED|95.0|-0.7|0.72|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.72|-0.70|0.514
91630005|NCT04984876|183152102|OTHER||LS Mean difference|0.04||||0.574|TWO_SIDED|95.0|-0.42|0.51|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.51|-0.42|0.574
91630006|NCT04984876|183152102|OTHER||LS Mean difference|-0.37||||0.056|TWO_SIDED|95.0|-0.83|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.09|-0.83|0.056
91630007|NCT04984876|183152102|OTHER||LS Mean difference|-0.36||||0.069|TWO_SIDED|95.0|-0.83|0.12|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.12|-0.83|0.069
91630008|NCT04984876|183152102|OTHER||LS Mean difference|-0.19||||0.205|TWO_SIDED|95.0|-0.65|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.27|-0.65|0.205
91630009|NCT04984876|183152102|OTHER||LS Mean difference|-0.2||||0.248|TWO_SIDED|95.0|-0.76|0.37|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.37|-0.76|0.248
91630010|NCT04984876|183152102|OTHER||LS Mean difference|-0.42||||0.071|TWO_SIDED|95.0|-0.98|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-0.98|0.071
91630011|NCT04984876|183152102|OTHER||LS Mean difference|-0.49||||0.048|TWO_SIDED|95.0|-1.06|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.09|-1.06|0.048
91630012|NCT04984876|183152102|OTHER||LS Mean difference|-0.3||||0.142|TWO_SIDED|95.0|-0.85|0.25|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.25|-0.85|0.142
91665302|NCT02583048|183223696|SUPERIORITY||Mean Difference (Net)|12.1|||||TWO_SIDED|95.1|5.7|18.6|||||Arm 3 minus Arm 2 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||18.6|5.7|
91489387|NCT02484690|182851571|SUPERIORITY||Difference in Least Squares Means|-7.68||||0.4244|TWO_SIDED|80.0|-20.01|4.64||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||4.64|-20.01|0.4244
91630013|NCT01077193|183152106|NON_INFERIORITY_OR_EQUIVALENCE|See above.|Mean Percent Excess Weight Loss|37.9|STANDARD_DEVIATION|25.18||0.3227|TWO_SIDED|95.0|30.2|45.5||No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.|t-test, 1 sided|||A sample size of 32 achieves power\>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.||45.5|30.2|0.3227
91630014|NCT04960202|183152107|SUPERIORITY||Percentage difference|-6.137|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-8.208|-4.066|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-4.066|-8.208|<0.0001
91630015|NCT04960202|183152110|SUPERIORITY||Percentage difference|-5.638|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.308|-3.967|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-3.967|-7.308|<0.0001
91630016|NCT04960202|183152111|SUPERIORITY||Hazard Ratio (HR)|1.294||||0.0003|TWO_SIDED|95.0|1.136|1.476|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 logarithm to base 10 \[log10\] copies/milliliter \[mL\], \>=4 log10 copies/mL) as covariates.||1.476|1.136|0.0003
91630017|NCT04960202|183152112|SUPERIORITY||Hazard Ratio (HR)|1.266|||<|0.0001|TWO_SIDED|95.0|1.134|1.412|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.412|1.134|<0.0001
91630018|NCT04960202|183152113|SUPERIORITY||Hazard Ratio (HR)|1.258|||<|0.0001|TWO_SIDED|95.0|1.131|1.4|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.400|1.131|<0.0001
91630019|NCT04960202|183152114|SUPERIORITY||Odds Ratio (OR)|0.871||||0.3473|TWO_SIDED|95.0|0.652|1.162|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.162|0.652|0.3473
91630020|NCT04960202|183152115|SUPERIORITY||Odds Ratio (OR)|0.936||||0.5762|TWO_SIDED|95.0|0.74|1.182|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.182|0.740|0.5762
91630021|NCT04960202|183152116|SUPERIORITY||Odds Ratio (OR)|0.969||||0.7807|TWO_SIDED|95.0|0.773|1.213|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.213|0.773|0.7807
91630022|NCT04960202|183152117|SUPERIORITY||Hazard Ratio (HR)|1.219||||0.0053|TWO_SIDED|95.0|1.061|1.401|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.401|1.061|0.0053
91630023|NCT04960202|183152118|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.0022|TWO_SIDED|95.0|1.068|1.348|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.348|1.068|0.0022
91630024|NCT04960202|183152119|SUPERIORITY||Hazard Ratio (HR)|1.194||||0.0021|TWO_SIDED|95.0|1.066|1.337|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.337|1.066|0.0021
91630025|NCT04960202|183152126|SUPERIORITY||Odds Ratio (OR)|1.088||||0.5293|TWO_SIDED|95.0|0.836|1.416|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.416|0.836|0.5293
91630026|NCT04960202|183152127|SUPERIORITY||Odds Ratio (OR)|1.053||||0.6379|TWO_SIDED|95.0|0.85|1.303|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.303|0.850|0.6379
91665303|NCT02583048|183223703|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.117|||||TWO_SIDED|90.0|0.884|1.411|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.411|0.884|
91665304|NCT02583048|183223703|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.989|1.461|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.461|0.989|
91665305|NCT02583048|183223703|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.958|||||TWO_SIDED|90.0|0.774|1.187|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.187|0.774|
91792121|NCT01077154|183462005|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.26|TWO_SIDED|95.0|0.92|1.36|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.36|0.92|0.26
91630027|NCT04960202|183152128|SUPERIORITY||Odds Ratio (OR)|1.046||||0.676|TWO_SIDED|95.0|0.848|1.29|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.290|0.848|0.6760
91630028|NCT04960202|183152129|SUPERIORITY||Odds Ratio (OR)|19.4||||0.1997||95.0|7.788|48.328|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||48.328|7.788|0.1997
91630029|NCT04960202|183152129|OTHER||Odds Ratio (OR)|8.948|||||TWO_SIDED|95.0|4.159|19.253|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||19.253|4.159|
91630030|NCT04960202|183152130|SUPERIORITY||Odds Ratio (OR)|20.875||||0.281|TWO_SIDED|95.0|10.097|43.156|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||43.156|10.097|0.2810
91630031|NCT04960202|183152130|SUPERIORITY||Odds Ratio (OR)|12.452|||||TWO_SIDED|95.0|6.823|22.725|||Breslow Day test||Odds ratio for Day 5 vs Day 1: Placebo|||22.725|6.823|
91630032|NCT04960202|183152131|SUPERIORITY||Odds Ratio (OR)|21.119||||0.2226|TWO_SIDED|95.0|10.412|42.837|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||42.837|10.412|0.2226
91630033|NCT04960202|183152131|SUPERIORITY||Odds Ratio (OR)|12.036||||0.2342|TWO_SIDED|95.0|6.808|21.28|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||21.280|6.808|0.2342
91630034|NCT03687827|183152148|SUPERIORITY|Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero.|Estimated treatment difference|1.43||||0.0321|TWO_SIDED|95.0|0.12|2.74|||t-test, 2 sided|||||2.74|0.12|0.0321
91630035|NCT03687827|183152148|NON_INFERIORITY|A non-inferiority margin of -0.83% has been applied, corresponding to 0.2 hours/24 hours|Estimated treatment difference|1.43|||||TWO_SIDED|95.0|0.12|2.74||||||||2.74|0.12|
91630036|NCT03377452|183152156|SUPERIORITY||Mean Difference (Final Values)|7.26|STANDARD_ERROR_OF_MEAN|6.02||0.2313|TWO_SIDED|95.0|-4.71|19.22|||t-test, 2 sided|||||19.22|-4.71|0.2313
91630037|NCT03377452|183152157|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-4.91|-1.72|||Mixed Models Analysis||The parameter estimate is the change in the outcome from baseline to 3-months after the last intervention/control session for the intervention group versus the same change in the control group.|||-1.72|-4.91|<0.001
91630038|NCT03146403|183152176|SUPERIORITY|||||||0.7474|||||||Wilcoxon (Mann-Whitney)|||||||0.7474
91630039|NCT03146403|183152177|SUPERIORITY|||||||0.645|||||||Wilcoxon (Mann-Whitney)|||||||0.6450
91630040|NCT03146403|183152178|SUPERIORITY|||||||0.3157|||||||Chi-squared|||||||0.3157
91630041|NCT03146403|183152179|SUPERIORITY|||||||0.3869|||||||Log Rank|||||||0.3869
91792122|NCT01077154|183462006|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.22|0.83|0.94
91630042|NCT03146403|183152180|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.2200
91665306|NCT02583048|183223704|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.986|||||TWO_SIDED|90.0|0.801|1.215|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.215|0.801|
91792123|NCT01077154|183462007|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.41|TWO_SIDED|95.0|0.92|1.21|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.21|0.92|0.41
91792124|NCT04030026|183462016|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|< 0.0001
91792125|NCT04030026|183462018|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|<0.0001
91630043|NCT02182999|183152183|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.596|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).||||0.596
91630044|NCT02182999|183152184|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
91630045|NCT00926185|183152193|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.06||||0.9381|TWO_SIDED|95.0|-0.26|0.39|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.39|-0.26|0.9381
91630046|NCT00926185|183152193|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.2||||0.3585|TWO_SIDED|95.0|-0.13|0.53|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.53|-0.13|0.3585
91482875|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||0.3728|TWO_SIDED|95.0|-24.25|9.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.23|-24.25|0.3728
91630047|NCT00926185|183152193|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.27||||0.1375|TWO_SIDED|95.0|-0.06|0.6|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.60|-0.06|0.1375
91630048|NCT00638690|183152195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||<|0.0001|TWO_SIDED|95.0|0.543|0.768||Nominal P-value is 0.0142 at interim analysis based on group sequential design.|Log Rank|This was a stratified analysis.||||0.768|0.543|<0.0001
91630049|NCT00638690|183152196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.462|0.728||Nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.728|0.462|<0.0001
91630050|NCT00638690|183152197|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.266|||<|0.001|TWO_SIDED|95.0|3.459|8.018||Nominal P-value = 0.05.|Chi-squared|||||8.018|3.459|<0.001
91630051|NCT00638690|183152198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.673|||<|0.0001|TWO_SIDED|95.0|0.585|0.776||The nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.776|0.585|<0.0001
91665307|NCT02583048|183223704|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.978|||||TWO_SIDED|90.0|0.764|1.251|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.251|0.764|
91665308|NCT02583048|183223704|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.859|||||TWO_SIDED|90.0|0.667|1.108|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.108|0.667|
91665309|NCT02583048|183223705|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.036|||||TWO_SIDED|90.0|0.847|1.267|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.267|0.847|
91665310|NCT02583048|183223705|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.037|||||TWO_SIDED|90.0|0.843|1.276|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.276|0.843|
91665311|NCT02583048|183223705|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.915|||||TWO_SIDED|90.0|0.727|1.151|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.151|0.727|
91665312|NCT02583048|183223706|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.043|||||TWO_SIDED|90.0|0.864|1.258|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.258|0.864|
91665313|NCT02583048|183223706|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.029|||||TWO_SIDED|90.0|0.858|1.235|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.235|0.858|
91665314|NCT02583048|183223706|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.657|0.993|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.993|0.657|
91665315|NCT02583048|183223707|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.068|||||TWO_SIDED|90.0|0.903|1.263|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.263|0.903|
91665316|NCT02583048|183223707|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.973|||||TWO_SIDED|90.0|0.82|1.155|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.155|0.820|
91665317|NCT02583048|183223707|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.803|||||TWO_SIDED|90.0|0.656|0.983|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.983|0.656|
91665318|NCT02583048|183223708|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.049|||||TWO_SIDED|90.0|0.881|1.248|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.248|0.881|
91665319|NCT02583048|183223708|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.979|||||TWO_SIDED|90.0|0.823|1.165|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.165|0.823|
91665320|NCT02583048|183223708|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.638|1.025|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.025|0.638|
91665321|NCT02583048|183223709|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.903|||||TWO_SIDED|90.0|0.778|1.049|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.049|0.778|
91665322|NCT02583048|183223709|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.114|||||TWO_SIDED|90.0|0.944|1.315|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.315|0.944|
91665323|NCT02583048|183223709|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.804|||||TWO_SIDED|90.0|0.639|1.012|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.012|0.639|
91665324|NCT02583048|183223710|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.937|||||TWO_SIDED|90.0|0.81|1.084|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.084|0.810|
91665325|NCT02583048|183223710|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.107|||||TWO_SIDED|90.0|0.929|1.318|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.318|0.929|
91665326|NCT02583048|183223710|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.856|||||TWO_SIDED|90.0|0.703|1.043|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.043|0.703|
91665327|NCT02583048|183223711|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.951|||||TWO_SIDED|90.0|0.825|1.096|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.096|0.825|
91665328|NCT02583048|183223711|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.136|||||TWO_SIDED|90.0|0.948|1.362|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.362|0.948|
91665329|NCT02583048|183223711|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.727|1.109|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.109|0.727|
91792126|NCT04030026|183462019|SUPERIORITY||Geometric Mean Ratio|0.47||||0.0087|TWO_SIDED|95.0|0.23|0.717||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.717|0.230|0.0087
91630052|NCT02203916|183152202|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.317|STANDARD_ERROR_OF_MEAN|2.4502|<|0.001|TWO_SIDED|95.0|-18.138|-8.497||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-8.497|-18.138|<0.001
91630053|NCT02203916|183152202|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.955|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-19.77|-10.141||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-10.141|-19.770|<0.001
91630054|NCT03152110|183152224|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||.203
91630055|NCT03152110|183152225|SUPERIORITY|||||||0.931|||||||t-test, 2 sided|||||||0.931
91630056|NCT01620593|183152264|SUPERIORITY|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91630057|NCT03536923|183152271|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
91630058|NCT03536923|183152272|OTHER|||||||0.0009|||||||t-test, 1 sided|||||||0.0009
91630059|NCT03536923|183152274|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
91630060|NCT03054740|183152275|SUPERIORITY||||||||||||||||||Levene's Test of Equality of Error Variances (Design: Intercept + Pain Previous IV + Intervention) F = .001, df1 = 1, df2=28, Sig. = .972|||
91630061|NCT03054740|183152276|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||.390
91630062|NCT01378299|183152280|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with last value carry forward.||||<0.05
91630063|NCT01378299|183152281|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward||||<0.05
91665330|NCT02583048|183223712|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.939|||||TWO_SIDED|90.0|0.806|1.094|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.094|0.806|
91630064|NCT01378299|183152282|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630065|NCT01378299|183152283|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630066|NCT01378299|183152284|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630067|NCT01378299|183152285|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630068|NCT01378299|183152286|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630069|NCT01378299|183152288|OTHER||||||<|0.05|||||||ANOVA|||Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline and with acceptable assay coefficient of variability were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.||||<0.05
91630070|NCT01378299|183152289|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630071|NCT01378299|183152290|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91630072|NCT01378299|183152291|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
91665331|NCT02583048|183223712|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.081|||||TWO_SIDED|90.0|0.864|1.352|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.352|0.864|
91665332|NCT02583048|183223712|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.597|1.253|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.253|0.597|
91665333|NCT02583048|183223713|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.825|1.095|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.095|0.825|
91665334|NCT02583048|183223713|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.862|1.354|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.354|0.862|
91665335|NCT02583048|183223713|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.605|1.239|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.239|0.605|
91665336|NCT02583048|183223714|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.851|1.138|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.138|0.851|
91792127|NCT04030026|183462020|SUPERIORITY|||||||0.0014||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0014
91792128|NCT04030026|183462020|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0001
91665337|NCT02583048|183223714|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.086|||||TWO_SIDED|90.0|0.866|1.361|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.361|0.866|
91665338|NCT02583048|183223714|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.927|||||TWO_SIDED|90.0|0.65|1.322|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.322|0.650|
91665339|NCT02155257|183223718|OTHER||Slope|0.19||||0.54|TWO_SIDED|95.0|-0.39|0.76|||Regression, Linear|||Interaction between resting pupil diameter and correlation of cognitive-affective style to pain reporting. Note that this analysis is an INTERACTION between the primary outcome of this measure (pupil diameter) to that of the primary outcome measure of cognitive-affective style.||.76|-.39|0.540
91665340|NCT00414726|183223721|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(\>20).||Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.||||0.91
91665341|NCT00414726|183223722|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.||||||0.68
91665342|NCT01993186|183223734|SUPERIORITY||Hodges-Lehmann estimate|13.45||||0.5812|TWO_SIDED|90.0|-38.63|80.95|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% confidence interval (CI) and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||80.95|-38.63|0.5812
91482876|NCT01227564|182839164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07||||0.3452|TWO_SIDED|95.0|-25.05|8.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||8.91|-25.05|0.3452
91482877|NCT02376283|182839207|OTHER|A p value \< 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student's independent sample t-tests. Categorical variables assessed using separate Fisher's exact (Chi-square) test.||||<0.05
91665343|NCT01993186|183223737|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.8197|TWO_SIDED|90.0|-51.23|84.25|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||84.25|-51.23|0.8197
91665344|NCT01993186|183223738|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.7276|TWO_SIDED|90.0|0.0|37.5|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||37.5|0|0.7276
91665345|NCT01993186|183223742|SUPERIORITY||Least squares mean difference|-2.384|STANDARD_ERROR_OF_MEAN|68.1231||0.486|TWO_SIDED|90.0|-114.44|109.67||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTISRTSD||109.67|-114.44|0.486
91665346|NCT01993186|183223742|SUPERIORITY||Least squares mean difference|63.669|STANDARD_ERROR_OF_MEAN|53.0537||0.8849|TWO_SIDED|90.0|-23.6|150.94||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDSRT||150.94|-23.6|0.8849
91665347|NCT01993186|183223742|SUPERIORITY||Least squares mean difference|-63.835|STANDARD_ERROR_OF_MEAN|60.6496||0.1463|TWO_SIDED|90.0|-163.59|35.93||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDFRT||35.93|-163.59|0.1463
91665348|NCT01993186|183223743|SUPERIORITY||Least squares mean difference|17.768|STANDARD_ERROR_OF_MEAN|11.5659||0.9378|TWO_SIDED|90.0|-1.26|36.79||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALTEA||36.79|-1.26|0.9378
91665349|NCT01993186|183223743|SUPERIORITY||Least squares mean difference|-0.531|STANDARD_ERROR_OF_MEAN|2.1853||0.5959|TWO_SIDED|90.0|-4.13|3.06||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALFTMS||3.06|-4.13|0.5959
91665350|NCT01993186|183223744|SUPERIORITY||Least squares mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.4988||0.4522|TWO_SIDED|90.0|-0.76|0.88||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SSPSLF||0.88|-0.76|0.4522
91665351|NCT01993186|183223745|SUPERIORITY||LS Mean Difference|-1.237|STANDARD_ERROR_OF_MEAN|2.381||0.3017|TWO_SIDED|90.0|-5.15|2.68||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMBE48||2.68|-5.15|0.3017
91665352|NCT01993186|183223745|SUPERIORITY||Least squares mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.6495||0.5235|TWO_SIDED|90.0|-1.03|1.11||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMS68||1.11|-1.03|0.5235
91665353|NCT01993186|183223746|SUPERIORITY||Least squares mean difference|-6.897|STANDARD_ERROR_OF_MEAN|22.4806||0.6205|TWO_SIDED|90.0|-43.874|30.08||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled||30.08|-43.874|0.6205
91665354|NCT01993186|183223747|SUPERIORITY||Least squares mean difference|-1.354|STANDARD_ERROR_OF_MEAN|3.5759||0.6476|TWO_SIDED|90.0|-7.236|4.527||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled (percent predicted)||4.527|-7.236|0.6476
91665355|NCT01993186|183223749|SUPERIORITY||Least squares mean difference|1.568|STANDARD_ERROR_OF_MEAN|3.8899||0.3435|TWO_SIDED|90.0|-4.83|7.97||One-sided p-value. Additional model covariates include baseline GMFM-88 total score, visit and the interaction between visit and treatment.|GEE model|||GMFM-88 UX007-Placebo||7.97|-4.83|0.3435
91665356|NCT02752074|183223765|OTHER||Hazard Ratio (HR)|1.0||||0.51711|TWO_SIDED|95.0|0.83|1.21||One-sided p-value based on log-rank test.|Log Rank|||||1.21|0.83|0.51711
91665357|NCT02752074|183223766|OTHER||Hazard Ratio (HR)|1.13||||0.80666|TWO_SIDED|95.0|0.86|1.49||One-sided p-value based on log-rank test.|Log Rank|||||1.49|0.86|0.80666
91665358|NCT00840216|183223775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|106.9||||||90.0|||||||Bioequivalence is established when the ratio of the mean falls within 80-125.|||||
91665359|NCT00840216|183223776|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
91665360|NCT00840216|183223777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
91482878|NCT02376283|182839207|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001|||||||ANOVA|ANOVA F(3,36) = 12.282||STEMI- clop vs prasl vs tic||||< 0.0001
91525589|NCT02608489|182926363|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||<0.001
91665361|NCT01604941|183223814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.296|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.2960
91665362|NCT01604941|183223814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0400
91665363|NCT01604941|183223814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6303|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.6303
91665364|NCT01604941|183223815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0365|TWO_SIDED|||||P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0365
91665365|NCT01604941|183223815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0019
91665366|NCT01604941|183223815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.1695
91665367|NCT01604941|183223816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0394
91665368|NCT01604941|183223816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0004
91665369|NCT01604941|183223816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0332|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.0332
91665370|NCT01604941|183223817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3202|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.3202
91665371|NCT01604941|183223817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4549|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.4549
91665372|NCT01604941|183223817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.3291
91665373|NCT01604941|183223818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6703|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for 50 mg/kg/d dosing||||0.6703
91665374|NCT01604941|183223818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2618|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for all participants with BID dosing||||0.2618
91665375|NCT01604941|183223818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7679|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 16 for all participants with BID dosing||||0.7679
91665376|NCT01604941|183223819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1683|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.1683
91665377|NCT01604941|183223819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0123|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0123
91665378|NCT01604941|183223819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2334|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.2334
91792129|NCT04030026|183462020|SUPERIORITY|||||||0.001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.001
91792130|NCT04030026|183462021|SUPERIORITY|||||||0.0198||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0198
91630073|NCT01448707|183152296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.|Non-Linear mixed|-7.9||||0.2331|TWO_SIDED|95.0|-14.64|-1.19||P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).|Mixed Models Analysis|Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates||||-1.19|-14.64|0.2331
91630074|NCT01448707|183152297|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-Linear mixed|-10.1||||0.6933|TWO_SIDED|95.0|-19.5|-0.73|||Mixed Models Analysis|||||-0.73|-19.50|0.6933
91630075|NCT01448707|183152298|NON_INFERIORITY_OR_EQUIVALENCE|Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-linear mixed model|-3.5||||0.0016|TWO_SIDED|95.0|-8.77|1.72|||Mixed Models Analysis|||||1.72|-8.77|0.0016
91630076|NCT01448707|183152298|NON_INFERIORITY_OR_EQUIVALENCE|Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|non-linear mixed model|-0.7||||0.0022|TWO_SIDED|95.0|-7.89|6.58|||Mixed Models Analysis|||||6.58|-7.89|0.0022
91630077|NCT02667392|183152305|OTHER|||||||0.77||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.77
91630078|NCT02667392|183152306|OTHER|||||||0.61||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.61
91630079|NCT02667392|183152307|OTHER|||||||0.28||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.28
91630080|NCT02667392|183152308|OTHER|||||||0.002||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.002
91630081|NCT02667392|183152309|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
91630082|NCT02667392|183152310|OTHER|||||||0.03||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.03
91630083|NCT02667392|183152311|OTHER|||||||0.55||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.55
91630084|NCT02667392|183152312|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.0089|||||||t-test, 2 sided|||||||0.0089
91630085|NCT02667392|183152313|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.73|||||||t-test, 2 sided|||||||0.73
91630086|NCT02667392|183152314|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.81|||||||t-test, 2 sided|||||||0.81
91630087|NCT02667392|183152315|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
91630088|NCT00383708|183152316|OTHER||||||<|0.0001|||||||Exact test|One-sided p value||The percentage of subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
91630089|NCT00383708|183152317|OTHER|||||||0.1654||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with pegvisomant (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.1654
91630090|NCT00383708|183152317|OTHER|||||||0.0115||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with lanreotide Autogel (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0115
91630091|NCT00383708|183152317|OTHER|||||||0.0003||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with octreotide LAR (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0003
91630092|NCT00383708|183152318|OTHER|||||||0.084||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.084
91630093|NCT00383708|183152318|OTHER||||||<|0.0001||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup non diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
91630094|NCT00383708|183152319|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'while taking final dose during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
91630095|NCT00383708|183152319|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'at any time during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
91630096|NCT02033850|183152346|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||Δs on ADL (baseline vs 6 months)||||.145
91630097|NCT02033850|183152346|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||Δs on ADL (6 vs 12 months)||||.618
91665379|NCT01410227|183223825|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis of the rate of subjects with a treatment success of \<= 0.65 (H0: p \<= 0.65) versus an alternative hypothesis of \> 0.65 (HA: p \> 0.65) was tested at the 5% one-sided level of significance. The proportion of subjects with treatment success under the alternative hypothesis was expected to be approximately 0.90. If 20 subjects were treated, the study provided 86% power to reject the null hypothesis.|Clopper-Pearson|100.0|||||TWO_SIDED|90.0|84.7|100.0|||Clopper-Pearson|||||100|84.7|
91525590|NCT02608489|182926364|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.045
91630098|NCT02033850|183152346|SUPERIORITY|||||||0.262|||||||t-test, 2 sided|||Δs on ADL (baseline vs 12 months)||||.262
91630099|NCT02033850|183152346|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Δs on IADL (baseline vs 6 months)||||.240
91630100|NCT02033850|183152346|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||Δs on IADL (6 vs 12 months)||||.134
91630101|NCT02033850|183152346|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||Δs on IADL (baseline vs 12 months)||||.457
91630102|NCT02033850|183152346|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||Δs on DAD (baseline vs 6 months)||||.612
91630103|NCT02033850|183152346|SUPERIORITY|||||||0.522|||||||t-test, 2 sided|||Δs on DAD (6 vs 12 months)||||.522
91630104|NCT02033850|183152346|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Δs on DAD (baseline vs 12 months)||||.800
91630105|NCT02033850|183152347|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Δs on AQ (baseline vs 6 months)||||.204
91630106|NCT02033850|183152347|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||Δs on AQ (6 vs 12 months)||||.810
91630107|NCT02033850|183152347|SUPERIORITY|||||||0.193|||||||t-test, 2 sided|||Δs on AQ (baseline vs 12 months)||||.193
91630108|NCT02033850|183152347|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 6 months)||||.698
91630109|NCT02033850|183152347|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||Δs on EQ index (6 vs 12 months)||||.283
91630110|NCT02033850|183152347|SUPERIORITY|||||||0.647|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 12 months)||||.647
91630111|NCT02033850|183152347|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 6 months)||||.057
91630112|NCT02033850|183152347|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Δs on EQ visual (6 vs 12 months)||||.685
91630113|NCT02033850|183152347|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 12 months)||||.056
91630114|NCT02033850|183152347|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Δs on GDS (baseline vs 6 months)||||.393
91630115|NCT02033850|183152347|SUPERIORITY|||||||0.958|||||||t-test, 2 sided|||Δs on GDS (6 vs 12 months)||||.958
91630116|NCT02033850|183152347|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Δs on GDS (baseline vs 12 months)||||.448
91630117|NCT02033850|183152347|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on MCS (baseline vs 6 months)||||.567
91630118|NCT02033850|183152347|SUPERIORITY|||||||0.274|||||||t-test, 2 sided|||Δs on MCS (6 vs 12 months)||||.274
91630119|NCT02033850|183152347|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||Δs on MCS (baseline vs 12 months)||||.668
91630120|NCT02033850|183152347|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||Δs on PCS (baseline vs 6 months)||||.709
91630121|NCT02033850|183152347|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on PCS (6 vs 12 months)||||.567
91630122|NCT02033850|183152347|SUPERIORITY|||||||0.867|||||||t-test, 2 sided|||Δs on PCS (baseline vs 12 months)||||.867
91630123|NCT02033850|183152348|SUPERIORITY|||||||0.095|||||||Chi-squared|||MCS outcome (baseline vs 6 months)||||.095
91630124|NCT02033850|183152348|SUPERIORITY|||||||0.729|||||||Chi-squared|||MCS outcome (6 vs 12 months)||||.729
91630125|NCT02033850|183152348|SUPERIORITY|||||||0.115|||||||Chi-squared|||MCS outcome (baseline vs 12 months)||||.115
91630126|NCT02033850|183152348|SUPERIORITY|||||||0.576|||||||Chi-squared|||PCS outcome (baseline vs 6 months)||||.576
91630127|NCT02033850|183152348|SUPERIORITY|||||||0.191|||||||Chi-squared|||PCS outcome (6 vs 12 months)||||.191
91630128|NCT02033850|183152348|SUPERIORITY|||||||0.79|||||||Chi-squared|||PCS outcome (baseline vs 12 months)||||.790
91630129|NCT02033850|183152349|SUPERIORITY|||||||0.936|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 6 months)||||.936
91630130|NCT02033850|183152349|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Δs on MoCA (6 vs 12 months)||||.188
91630131|NCT02033850|183152349|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 12 months)||||.381
91630132|NCT02033850|183152349|SUPERIORITY|||||||0.458|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 6 months)||||.458
91630133|NCT02033850|183152349|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||Δs on MMSE (6 vs 12 months)||||.236
91630134|NCT02033850|183152349|SUPERIORITY|||||||0.601|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 12 months)||||.601
91630135|NCT02033850|183152349|SUPERIORITY|||||||0.839|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 6 months)||||.839
91630136|NCT02033850|183152349|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||Δs on RAVL immediate (6 vs 12 months)||||.021
91630137|NCT02033850|183152349|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 12 months)||||.032
91630138|NCT02033850|183152349|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 6 months)||||.858
91630139|NCT02033850|183152349|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Δs on RAVL recall (6 vs 12 months)||||.212
91630140|NCT02033850|183152349|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 12 months)||||.268
91630141|NCT02033850|183152349|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 6 months)||||.184
91630142|NCT02033850|183152349|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||Δs on ROCF recall (6 vs 12 months)||||.358
91630143|NCT02033850|183152349|SUPERIORITY|||||||0.768|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 12 months)||||.768
91630144|NCT02033850|183152349|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Δs on short story (baseline vs 6 months)||||.164
91630145|NCT02033850|183152349|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Δs on short story (6 vs 12 months)||||.420
91630146|NCT02033850|183152349|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||Δs on short story (baseline vs 12 months)||||.527
91630147|NCT02033850|183152349|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||Δs on visual search (baseline vs 6 months)||||.762
91665380|NCT00606281|183223892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-9.4|-2.7|||ANCOVA|||||-2.7|-9.4|<0.001
91482879|NCT02376283|182839207|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(2,40) = 29.097||NSTEMI- clopidogrel vs prasugrel vs ticagrelor||||< 0.0001
91630148|NCT02033850|183152349|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||Δs on visual search (6 vs 12 months)||||.405
91630149|NCT02033850|183152349|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||Δs on visual search (baseline vs 12 months)||||.674
91630150|NCT02033850|183152349|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 6 months)||||.328
91630151|NCT02033850|183152349|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||Δs on SDMT (6 vs 12 months)||||.198
91630152|NCT02033850|183152349|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 12 months)||||.639
91630153|NCT02033850|183152349|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 6 months)||||.098
91630154|NCT02033850|183152349|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||Δs on ROCF copy (6 vs 12 months)||||.235
91630155|NCT02033850|183152349|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 12 months)||||.789
91630156|NCT02033850|183152350|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 6 months)||||.743
91630157|NCT02033850|183152350|SUPERIORITY|||||||0.428|||||||t-test, 2 sided|||Δs on Stroop test (6 vs 12 months)||||.428
91630158|NCT02033850|183152350|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 12 months)||||.294
91630159|NCT02033850|183152350|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 6 months)||||.157
91630160|NCT02033850|183152350|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||Δs on TMT-A (6 vs 12 months)||||.094
91630161|NCT02033850|183152350|SUPERIORITY|||||||0.476|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 12 months)||||.476
91630162|NCT02033850|183152350|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 6 months)||||.142
91630163|NCT02033850|183152350|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Δs on TMT-B (6 vs 12 months)||||.651
91630164|NCT02033850|183152350|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 12 months)||||.534
91630165|NCT02033850|183152351|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 6 months)||||.882
91630166|NCT02033850|183152351|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Δs on phonemic fluency (6 vs 12 months)||||.835
91630167|NCT02033850|183152351|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 12 months)||||.951
91630168|NCT02033850|183152351|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 6 months)||||.392
91630169|NCT02033850|183152351|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||Δs on semantic fluency (6 vs 12 months)||||.973
91630170|NCT02033850|183152351|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 12 months)||||.486
91630171|NCT02033850|183152352|SUPERIORITY|||||||0.92|||||||Chi-squared|||MoCA variations (baseline vs 6 months)||||.920
91630172|NCT02033850|183152352|SUPERIORITY|||||||0.17|||||||Chi-squared|||MoCA variations (6 vs 12 months)||||.170
91630173|NCT02033850|183152352|SUPERIORITY|||||||0.716|||||||Chi-squared|||MoCA variations (baseline vs 12 months)||||.716
91630174|NCT02033850|183152352|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (baseline vs 6 months)||||.973
91630175|NCT02033850|183152352|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (6 vs 12 months)||||.973
91630176|NCT02033850|183152352|SUPERIORITY|||||||0.3|||||||Chi-squared|||MMSE variations (baseline vs 12 months)||||.300
91630177|NCT02033850|183152352|SUPERIORITY|||||||0.068|||||||Chi-squared|||RAVL immed. variations (baseline vs 6 months)||||.068
91630178|NCT02033850|183152352|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL immed. variations (6 vs 12 months)||||.089
91630179|NCT02033850|183152352|SUPERIORITY|||||||0.241|||||||Chi-squared|||RAVL immed. variations (baseline vs 12 months)||||.241
91630180|NCT02033850|183152352|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL recall variations (baseline vs 6 months)||||.089
91630181|NCT02033850|183152352|SUPERIORITY|||||||0.17|||||||Chi-squared|||RAVL recall variations (6 vs 12 months)||||.170
91630182|NCT02033850|183152352|SUPERIORITY|||||||0.413|||||||Chi-squared|||RAVL recall variations (baseline vs 12 months)||||.413
91630183|NCT02033850|183152352|SUPERIORITY|||||||0.777|||||||Chi-squared|||ROCF recall variations (baseline vs 6 months)||||.777
91630184|NCT02033850|183152352|SUPERIORITY|||||||0.134|||||||Chi-squared|||ROCF recall variations (6 vs 12 months)||||.134
91630185|NCT02033850|183152352|SUPERIORITY|||||||0.498|||||||Chi-squared|||ROCF recall variations (baseline vs 12 months)||||.498
91630186|NCT02033850|183152352|SUPERIORITY|||||||0.942|||||||Chi-squared|||Short story variations (baseline vs 6 months)||||.942
91630187|NCT02033850|183152352|SUPERIORITY|||||||0.578|||||||Chi-squared|||Short story variations (6 vs 12 months)||||.578
91630188|NCT02033850|183152352|SUPERIORITY|||||||0.413|||||||Chi-squared|||Short story variations (baseline vs 12 months)||||.413
91630189|NCT02033850|183152352|SUPERIORITY|||||||1|||||||Chi-squared|||Visual search variations (baseline vs 6 months)||||1
91630190|NCT02033850|183152352|SUPERIORITY|||||||0.038|||||||Chi-squared|||Visual search variations (6 vs 12 months)||||.038
91630191|NCT02033850|183152352|SUPERIORITY|||||||0.658|||||||Chi-squared|||Visual search variations (baseline vs 12 months)||||.658
91665381|NCT00606281|183223893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|<0.001
91665382|NCT00540423|183223895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|60.0||||||95.0|35.21|84.79|||||The units of risk difference is percentage.|||84.79|35.21|
91665383|NCT00540423|183223897|SUPERIORITY_OR_OTHER||Percentage of 75% responders|43.5||||||95.0|23.19|65.51|||||Confidence interval of the percentage of participants for whom at least 75% of their assessments during the course of 26 weeks of SB-494115-GR treatment met the definition of responders.|||65.51|23.19|
91630192|NCT02033850|183152352|SUPERIORITY|||||||0.522|||||||Chi-squared|||SDMT variations (baseline vs 6 months)||||.522
91630193|NCT02033850|183152352|SUPERIORITY|||||||0.674|||||||Chi-squared|||SDMT variations (6 vs 12 months)||||.674
91630194|NCT02033850|183152352|SUPERIORITY|||||||0.17|||||||Chi-squared|||SDMT variations (baseline vs 12 months)||||.170
91665384|NCT03131895|183223919|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) confidence intervals (CIs) on the original scale.|Least square (LS) mean ratio|1.0436||||0.5535|TWO_SIDED|90.0|0.9453|1.1521|||ANOVA|||||1.1521|0.9453|0.5535
91665385|NCT03131895|183223919|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0185||||0.892|TWO_SIDED|90.0|0.9334|1.1113|||ANOVA|||||1.1113|0.9334|0.8920
91665386|NCT03131895|183223920|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.039||||0.3209|TWO_SIDED|90.0|0.9792|1.1024|||ANOVA|||||1.1024|0.9792|0.3209
91665387|NCT03131895|183223920|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0353||||0.3896|TWO_SIDED|90.0|0.9719|1.1029|||ANOVA|||||1.1029|0.9719|0.3896
91665388|NCT03131895|183223921|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0335||||0.4163|TWO_SIDED|90.0|0.9733|1.0975|||ANOVA|||||1.0975|0.9733|0.4163
91792131|NCT04030026|183462021|SUPERIORITY|||||||0.0374||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0374
91792132|NCT04030026|183462021|SUPERIORITY|||||||0.2982||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.2982
91525591|NCT02608489|182926365|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.001
91630195|NCT02033850|183152352|SUPERIORITY|||||||0.961|||||||Chi-squared|||Stroop test variations (baseline vs 6 months)||||.961
91630196|NCT02033850|183152352|SUPERIORITY|||||||0.413|||||||Chi-squared|||Stroop test variations (6 vs 12 months)||||.413
91630197|NCT02033850|183152352|SUPERIORITY|||||||0.477|||||||Chi-squared|||Stroop test variations (baseline vs 12 months)||||.477
91630198|NCT02033850|183152352|SUPERIORITY|||||||0.42|||||||Chi-squared|||TMT-A variations (baseline vs 6 months)||||.420
91630199|NCT02033850|183152352|SUPERIORITY|||||||0.241|||||||Chi-squared|||TMT-A variations (6 vs 12 months)||||.241
91630200|NCT02033850|183152352|SUPERIORITY|||||||0.295|||||||Chi-squared|||TMT-A variations (baseline vs 12 months)||||.295
91665389|NCT03131895|183223921|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0031||||0.9778|TWO_SIDED|90.0|0.9458|1.0638|||ANOVA|||||1.0638|0.9458|0.9778
91792133|NCT04030026|183462022|SUPERIORITY|||||||0.0054||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo)|Student's T-test|||Change from baseline at Day 8||||0.0054
91630201|NCT02033850|183152352|SUPERIORITY|||||||0.453|||||||Chi-squared|||TMT-B variations (baseline vs 6 months)||||.453
91630202|NCT02033850|183152352|SUPERIORITY|||||||0.952|||||||Chi-squared|||TMT-B variations (6 vs 12 months)||||.952
91630203|NCT02033850|183152352|SUPERIORITY|||||||0.881|||||||Chi-squared|||TMT-B variations (baseline vs 12 months)||||.881
91665390|NCT01339247|183223922|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0886|||||TWO_SIDED|90.0|1.0011|1.177|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.1770|1.0011|
91665391|NCT01339247|183223923|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0246|||||TWO_SIDED|90.0|0.9676|1.0849|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0849|0.9676|
91665392|NCT01339247|183223924|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0317|||||TWO_SIDED|90.0|0.9716|1.0956|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0956|0.9716|
91665393|NCT02213263|183223945|EQUIVALENCE|Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.|Difference in ORR|4.66|||||TWO_SIDED|95.0|-4.16|13.47||||||Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||13.47|-4.16|
91714248|NCT01656395|183320226|SUPERIORITY||Mean Difference (Final Values)|0.319||||0.086|TWO_SIDED|95.0|-0.045|0.683|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.683|-0.045|0.086
91482880|NCT02376283|182839208|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
91482881|NCT02376283|182839208|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||=|0.123|||||||ANOVA|ANOVA F(6,56)=1.707||STEMI- different drugs (as stated above)||||=0.123
91714249|NCT01656395|183320227|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7687|TWO_SIDED|95.0|-16.0|21.3|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).||21.3|-16.0|0.7687
91482882|NCT02376283|182839208|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(4,62)=18.932||NSTEMI- different drugs (as stated above)||||<0.0001
91482883|NCT02376283|182839209|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
91525592|NCT02608489|182926365|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||0.002
91630204|NCT02033850|183152352|SUPERIORITY|||||||0.413|||||||Chi-squared|||Phonemic fluency variations (baseline vs 6 months)||||.413
91630205|NCT02033850|183152352|SUPERIORITY|||||||0.961|||||||Chi-squared|||Phonemic fluency variations (6 vs 12 months)||||.961
91630206|NCT02033850|183152352|SUPERIORITY|||||||0.951|||||||Chi-squared|||Phonemic fluency variation (baseline vs 12 months)||||.951
91525593|NCT02608489|182926365|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||0.034
91630207|NCT02033850|183152352|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variations (baseline vs 6 months)||||.951
91630208|NCT02033850|183152352|SUPERIORITY|||||||0.674|||||||Chi-squared|||Semantic fluency variations (6 vs 12 months)||||.674
91630209|NCT02033850|183152352|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variation (baseline vs 12 months)||||.951
91630210|NCT02033850|183152352|SUPERIORITY|||||||1|||||||Chi-squared|||ROCF copy variations (baseline vs 6 months)||||1
91630211|NCT02033850|183152352|SUPERIORITY|||||||0.027|||||||Chi-squared|||ROCF copy variations (6 vs 12 months)||||.027
91630212|NCT02033850|183152352|SUPERIORITY|||||||0.169|||||||Chi-squared|||ROCF copy variations (baseline vs 12 months)||||.169
91630213|NCT02033850|183152353|SUPERIORITY|||||||0.478|||||||Chi-squared|||||||.478
91714250|NCT01656395|183320227|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.4943|TWO_SIDED|95.0|-24.9|12.2|||MN Method|||Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||12.2|-24.9|0.4943
91714251|NCT01656395|183320227|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.3003|TWO_SIDED|95.0|-9.4|29.6|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||29.6|-9.4|0.3003
91714252|NCT01656395|183320227|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0774|TWO_SIDED|95.0|-1.9|35.7|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.7|-1.9|0.0774
91714253|NCT01656395|183320227|SUPERIORITY||Mean Difference (Final Values)|18.2||||0.0555|TWO_SIDED|95.0|-0.4|35.5|||MN method|||Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.5|-0.4|0.0555
91792134|NCT04030026|183462022|SUPERIORITY||||||<|0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 15||||<0.0001
91665394|NCT02213263|183223951|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.45|TWO_SIDED|95.0|0.786|1.72||A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||1.720|0.786|0.450
91665395|NCT02213263|183223952|SUPERIORITY||Hazard Ratio (HR)|1.393||||0.189|TWO_SIDED|95.0|0.847|2.291|||Log Rank|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.|Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.291|0.847|0.189
91665396|NCT02213263|183223953|SUPERIORITY||Mean Difference (Final Values)|-2.31|||||TWO_SIDED|95.0|-11.09|6.5||||||Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||6.50|-11.09|
91665397|NCT02213263|183223954|SUPERIORITY||Hazard Ratio (HR)|1.492||||0.185|TWO_SIDED|95.0|0.823|2.704||A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.704|0.823|0.185
91665398|NCT02213263|183223955|SUPERIORITY||Hazard Ratio (HR)|2.94||||0.319|TWO_SIDED|95.0|0.0||Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||||0.000|0.319
91482884|NCT02376283|182839209|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||=|0.81||||||STEMI- clopidogrel vs prasugrel vs ticagrelor|ANOVA|ANOVA F(3,17) = 0.321||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||=0.810
91665399|NCT02960295|183224046|OTHER|There was no comparison group and no test of statistical significance.||||||||||||||||In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.|This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day|||
91665400|NCT02960295|183224047|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation (r)|||||||<0.05
91714254|NCT01656395|183320228|SUPERIORITY||Mean Difference (Final Values)|-0.104||||0.603|TWO_SIDED|95.0|-0.495|0.288|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.288|-0.495|0.603
91525594|NCT02608489|182926366|SUPERIORITY_OR_OTHER|||||||0.151|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.151
91665401|NCT02960295|183224047|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
91665402|NCT02960295|183224047|OTHER||||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
91665403|NCT01075282|183224050|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of LY2189265 1.5 mg vs insulin glargine on HbA1c change from baseline at the 52-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 20%.||-0.29|-0.60|<0.001
91665404|NCT01075282|183224050|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.13|||<|0.001|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.02|-0.29|<0.001
91665405|NCT01075282|183224050|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.29|-0.60|<0.001
91665406|NCT01075282|183224050|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.05|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.02|-0.29|0.05
91665407|NCT01075282|183224051|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.37|-0.65|<0.001
91714255|NCT01656395|183320228|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.875|TWO_SIDED|95.0|-0.436|0.372|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.372|-0.436|0.875
91714256|NCT01656395|183320228|SUPERIORITY||Mean Difference (Final Values)|-0.151||||0.476|TWO_SIDED|95.0|-0.568|0.265|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.265|-0.568|0.476
91792135|NCT04030026|183462022|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 21||||0.0001
91630214|NCT02033850|183152354|SUPERIORITY|||||||0.029||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in vermis VIIIb||||0.029
91630215|NCT02033850|183152354|SUPERIORITY|||||||0.04||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in right VIIb lobule||||0.04
91630216|NCT02033850|183152354|SUPERIORITY|||||||0.039||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in left VIIb lobule||||0.039
91665408|NCT01075282|183224051|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.10|-0.38|<0.001
91665409|NCT01075282|183224051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.37|-0.65|<0.001
91665410|NCT01075282|183224051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.10|-0.38|<0.001
91665411|NCT01075282|183224051|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.13|-0.50|<0.001
91665412|NCT01075282|183224051|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.03|||<|0.001|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.15|-0.21|<0.001
91665413|NCT01075282|183224051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.13|-0.50|<0.001
91665414|NCT01075282|183224051|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.378|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.15|-0.21|0.378
91665415|NCT01075282|183224052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|2.98|7.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.11|2.98|<0.001
91792136|NCT04030026|183462023|SUPERIORITY|||||||0.0107||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0107
91665416|NCT01075282|183224052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.41|3.24||Treatment comparison at 26 weeks.|Regression, Logistic|||||3.24|1.41|<0.001
91665417|NCT01075282|183224052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.001|TWO_SIDED|95.0|2.45|5.75||Treatment comparison at 52 weeks.|Regression, Logistic|||||5.75|2.45|<0.001
91665418|NCT01075282|183224052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.098|TWO_SIDED|95.0|0.94|2.15||Treatment comparison at 52 weeks.|Regression, Logistic|||||2.15|0.94|0.098
91665419|NCT01075282|183224052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.85|4.14||Treatment comparison at 78 weeks.|Regression, Logistic|||||4.14|1.85|<0.001
91665420|NCT01075282|183224052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.334|TWO_SIDED|95.0|0.82|1.82||Treatment comparison at 78 weeks.|Regression, Logistic|||||1.82|0.82|0.334
91665421|NCT01075282|183224053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.9|7.63||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.63|2.90|<0.001
91665422|NCT01075282|183224053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.57|4.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||4.11|1.57|<0.001
91665423|NCT01075282|183224053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.001|TWO_SIDED|95.0|1.81|4.85||Treatment comparison at 52 weeks.|Regression, Logistic|||||4.85|1.81|<0.001
91665424|NCT01075282|183224053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.004|TWO_SIDED|95.0|1.26|3.39||Treatment comparison at 52 weeks.|Regression, Logistic|||||3.39|1.26|0.004
91792137|NCT04030026|183462023|SUPERIORITY|||||||0.0051||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change for baseline at Day 16||||0.0051
91792138|NCT04030026|183462023|SUPERIORITY|||||||0.1513||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.1513
91630217|NCT02820038|183152355|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8408|TWO_SIDED|95.0|0.52|2.24|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||2.24|0.52|0.8408
91630218|NCT02820038|183152355|SUPERIORITY||Odds Ratio (OR)|1.18||||0.58|TWO_SIDED|95.0|0.66|2.12|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or Other CMI+SMART, 1=DFB or DFB + SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.12|0.66|0.58
91630219|NCT02820038|183152355|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1937|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||2.68|0.82|0.1937
91630220|NCT02820038|183152355|SUPERIORITY||Odds Ratio (OR)|2.379||||0.0193|TWO_SIDED|95.0|1.15|4.92|||Regression, Logistic|Sample restricted to participants who did not meet the criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who did not meet criteria for informed decision-making at baseline.||4.92|1.15|0.0193
91630221|NCT02820038|183152355|SUPERIORITY||Odds Ratio (OR)|0.53||||0.2216|TWO_SIDED|95.0|0.19|1.48|||Regression, Logistic||Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who met the criteria for informed decision-making at baseline.||1.48|0.19|0.2216
91665425|NCT01075282|183224053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.44|3.57||Treatment comparison at 78 weeks.|Regression, Logistic|Treatment comparison at 78 weeks.||||3.57|1.44|<0.001
91665426|NCT01075282|183224053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.073|TWO_SIDED|95.0|0.96|2.42||Treatment comparison at 78 weeks.|Regression, Logistic|||||2.42|0.96|0.073
91665427|NCT01075282|183224054|SUPERIORITY_OR_OTHER|||||||0.109||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.109
91665428|NCT01075282|183224054|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.335
91482885|NCT02376283|182839209|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.0001||||||NSTEMI- clopi vs pras vs tic|ANOVA|ANOVA F(2,25) = 14.103||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||< 0.0001
91482886|NCT02378025|182839210|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
91482887|NCT02378025|182839211|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
91665429|NCT01075282|183224054|SUPERIORITY_OR_OTHER|||||||0.091||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.091
91665430|NCT01075282|183224054|SUPERIORITY_OR_OTHER|||||||0.4||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.400
91665431|NCT01075282|183224054|SUPERIORITY_OR_OTHER|||||||0.641||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.641
91665432|NCT01075282|183224054|SUPERIORITY_OR_OTHER|||||||0.055||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.055
91665433|NCT01075282|183224057|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|||<|0.001|TWO_SIDED|95.0|2.33|3.33||Treatment comparison at 26 weeks.|ANCOVA|||||3.33|2.33|<0.001
91665434|NCT01075282|183224057|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.99|2.99||Treatment comparison at 26 weeks.|ANCOVA|||||2.99|1.99|<0.001
91665435|NCT01075282|183224057|SUPERIORITY_OR_OTHER||LS Mean Difference|3.31|||<|0.001|TWO_SIDED|95.0|2.71|3.9||Treatment comparison at 52 weeks.|ANCOVA|||||3.90|2.71|<0.001
91665436|NCT01075282|183224057|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|2.17|3.36||Treatment comparison at 52 weeks.|ANCOVA|||||3.36|2.17|<0.001
91665437|NCT01075282|183224057|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|||<|0.001|TWO_SIDED|95.0|2.59|3.89||Treatment comparison at 78 weeks.|ANCOVA|||||3.89|2.59|<0.001
91665438|NCT01075282|183224057|SUPERIORITY_OR_OTHER||LS Mean Difference|2.82|||<|0.001|TWO_SIDED|95.0|2.17|3.46||Treatment comparison at 78 weeks.|ANCOVA|||||3.46|2.17|<0.001
91665439|NCT00367133|183224076|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P values for two group comparisons for difference in mean change.||||0.02
91665440|NCT00367133|183224076|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.002
91792139|NCT04030026|183462024|SUPERIORITY|||||||0.3601||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||||||0.3601
91482888|NCT02378025|182839212|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
91630222|NCT02820038|183152356|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.83|STANDARD_ERROR_OF_MEAN|1.32||0.163|TWO_SIDED|95.0|-1.83|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-1.83|0.1630
91630223|NCT02820038|183152356|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.05||0.7892|TWO_SIDED|95.0|-2.33|1.77|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.77|-2.33|0.7892
91630224|NCT02820038|183152356|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-2.19|STANDARD_ERROR_OF_MEAN|1.05||0.0377|TWO_SIDED|95.0|-4.25|-0.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||-0.13|-4.25|0.0377
91630225|NCT02820038|183152357|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.53||0.9216|TWO_SIDED|95.0|-0.98|1.08|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in values favorable to aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.08|-0.98|0.9216
91630226|NCT02820038|183152357|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.42||0.3843|TWO_SIDED|95.0|-0.45|1.17|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.17|-0.45|0.3843
91630227|NCT02820038|183152357|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.42||0.509|TWO_SIDED|95.0|-0.54|1.09|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.09|-0.54|0.5090
91630228|NCT02820038|183152358|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.23||0.1486|TWO_SIDED|95.0|-0.77|0.12|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.12|-0.77|0.1486
91630229|NCT02820038|183152358|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4888|TWO_SIDED|95.0|-0.47|0.22|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.22|-0.47|0.4888
91665441|NCT00367133|183224076|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.49
91665442|NCT00367133|183224079|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.03
91482889|NCT02378025|182839213|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||||||.25
91482890|NCT02378025|182839214|SUPERIORITY|||||||0.22|||||||Regression, Logistic|||||||.22
91482891|NCT02378025|182839215|SUPERIORITY|||||||0.41|||||||Regression, Logistic|||||||.41
91482892|NCT00744471|182839267|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.87|-0.69||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.69|-1.87|<0.001
91665443|NCT00367133|183224079|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.01
91665444|NCT00367133|183224079|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.82
91665445|NCT00367133|183224080|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P value not adjusted for multiple comparisons||||<0.001
91714257|NCT01656395|183320228|SUPERIORITY||Mean Difference (Final Values)|-0.362||||0.079|TWO_SIDED|95.0|-0.767|0.042|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.042|-0.767|0.079
91714258|NCT01656395|183320228|SUPERIORITY||Mean Difference (Final Values)|-0.227||||0.257|TWO_SIDED|95.0|-0.621|0.166|||cLDA model|||"Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.~cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast)."||0.166|-0.621|0.257
91714259|NCT01656395|183320229|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.742|TWO_SIDED|95.0|-15.1|21.1|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||21.1|-15.1|0.742
91714260|NCT01656395|183320229|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.7248|TWO_SIDED|95.0|-22.1|15.4|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||15.4|-22.1|0.7248
91714261|NCT01656395|183320229|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.6991|TWO_SIDED|95.0|-15.6|22.6|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||22.6|-15.6|0.6991
91714262|NCT01656395|183320229|SUPERIORITY||Mean Difference (Final Values)|8.1||||0.3934|TWO_SIDED|95.0|-10.6|26.2|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||26.2|-10.6|0.3934
91482893|NCT00744471|182839267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.28|-1.1||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.10|-2.28|<0.001
91714263|NCT01656395|183320229|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8032|TWO_SIDED|95.0|-16.0|20.5|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||20.5|-16.0|0.8032
91714264|NCT01656395|183320230|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.873|TWO_SIDED|95.0|-1.004|0.853|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.853|-1.004|0.873
91792140|NCT06372782|183462059|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||Within-Subject Difference in VAS Score at the End of Injection (FAS)||||<0.0001
91792141|NCT00562627|183462073|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
91792142|NCT00562627|183462074|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
91482894|NCT00744471|182839267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.34|-1.16||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.16|-2.34|<0.001
91665446|NCT00367133|183224080|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||<0.001
91665447|NCT00367133|183224080|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||0.91
91665448|NCT00367133|183224082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
91665449|NCT00367133|183224082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
91665450|NCT00367133|183224082|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||0.60
91665451|NCT00367133|183224083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
91665452|NCT00367133|183224083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||<0.001
91665453|NCT00367133|183224083|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||0.55
91665454|NCT00906399|183224096|SUPERIORITY_OR_OTHER||Rate Ratio|0.725||||0.0114|TWO_SIDED|95.0|0.565|0.93|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40 years).||||0.930|0.565|0.0114
91630230|NCT02820038|183152358|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.8637|TWO_SIDED|95.0|-0.32|0.38|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.38|-0.32|0.8637
91630231|NCT02820038|183152359|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.507|TWO_SIDED|95.0|-0.33|0.66|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.66|-0.33|0.5070
91630232|NCT02820038|183152359|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4821|TWO_SIDED|95.0|-0.25|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.25|0.4821
91630233|NCT02820038|183152359|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7777|TWO_SIDED|95.0|-0.33|0.44|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.44|-0.33|0.7777
91630234|NCT02820038|183152360|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.64||0.6084|TWO_SIDED|95.0|-0.93|1.58|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.58|-0.93|0.6084
91630235|NCT02820038|183152360|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.597|TWO_SIDED|95.0|-0.71|1.23|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.23|-0.71|0.5970
91630236|NCT02820038|183152360|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.5||0.5094|TWO_SIDED|95.0|-0.65|1.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.31|-0.65|.5094
91630237|NCT02820038|183152361|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.48|STANDARD_ERROR_OF_MEAN|2.74||0.5866|TWO_SIDED|95.0|-6.85|3.89|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.89|-6.85|0.5866
91665455|NCT00906399|183224096|SUPERIORITY_OR_OTHER||Rate Ratio|0.644||||0.0007|TWO_SIDED|95.0|0.5|0.831|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40).||||0.831|0.500|0.0007
91665456|NCT00906399|183224097|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.72||||0.0008|TWO_SIDED|95.0|0.6|0.87|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.87|0.60|0.0008
91665457|NCT00906399|183224097|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.27|0.4|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.40|0.27|<0.0001
91792143|NCT00562627|183462075|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91792144|NCT04948866|183462083|SUPERIORITY|||||||0.522|||||||Poisson regression|||||||0.522
91792145|NCT04948866|183462084|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91792146|NCT04948866|183462085|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||||||0.402
91792147|NCT04948866|183462086|SUPERIORITY|||||||0.803|||||||t-test, 2 sided|||||||0.803
91482895|NCT00744471|182839268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.74|-0.61||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect.||-0.61|-1.74|<0.001
91665458|NCT00906399|183224098|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.02|TWO_SIDED|95.0|0.57|0.95||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.95|0.57|0.0200
91665459|NCT00906399|183224098|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0003|TWO_SIDED|95.0|0.47|0.8||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.80|0.47|0.0003
91665460|NCT00906399|183224099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.038|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0380
91665461|NCT00906399|183224099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0383|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0383
91665462|NCT02055547|183224146|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|4.61|||<|0.001|TWO_SIDED|90.0|3.69|5.76|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|5.76|3.69|<0.001
91792148|NCT04948866|183462087|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||||||0.045
91792149|NCT04948866|183462088|SUPERIORITY|||||||0.977|||||||Chi-squared|||||||0.977
91665463|NCT02055547|183224146|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|2.67|||<|0.001|TWO_SIDED|90.0|2.12|3.36|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|3.36|2.12|<0.001
91665464|NCT02055547|183224146|OTHER|"Treatment comparison (MK-8521 125μg - MK-8521 35μg) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs.~MK-8521 35μg was calculated from the model."|Geometric mean ratio|1.73|||<|0.001|TWO_SIDED|90.0|1.38|2.16|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|2.16|1.38|<0.001
91665465|NCT02055547|183224147|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|3.04|||<|0.001|TWO_SIDED|90.0|2.62|3.53|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|3.53|2.62|<0.001
91665466|NCT02055547|183224147|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|1.94|||<|0.001|TWO_SIDED|90.0|1.67|2.26|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|2.26|1.67|<0.001
91665467|NCT02055547|183224147|OTHER|Treatment comparison (MK-8521 125μg - 35μg) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg - 35μg was calculated from the model.|Geometric mean ratio|1.57|||<|0.001|TWO_SIDED|90.0|1.35|1.82|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|1.82|1.35|<0.001
91665468|NCT02055547|183224148|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125mcg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.65|||<|0.001|TWO_SIDED|90.0|0.6|0.7|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.7|0.6|<0.001
91792150|NCT04948866|183462089|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
91792151|NCT04948866|183462090|SUPERIORITY|||||||0.935|||||||Chi-squared|||||||0.935
91792152|NCT04948866|183462091|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91792153|NCT04948866|183462092|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91792154|NCT04948866|183462093|SUPERIORITY|||||||0.417|||||||Chi-squared|||||||0.417
91792155|NCT04948866|183462094|SUPERIORITY|||||||0.531|||||||Chi-squared|||||||0.531
91792156|NCT04948866|183462095|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
91792157|NCT04948866|183462096|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
91792158|NCT04251156|183462111|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Treatment difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-10.17|-6.76|||ANCOVA|||Treatment policy estimand||-6.76|-10.17|<0.0001
91792159|NCT04251156|183462112|SUPERIORITY|Responses were analysed using a binary logistic regression model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Odds Ratio (OR)|13.07|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Regression, Logistic|||Treatment policy estimand||23.10|7.40|<0.0001
91630238|NCT02820038|183152361|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.13||0.8689|TWO_SIDED|95.0|-3.82|4.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.52|-3.82|0.8689
91630239|NCT02820038|183152361|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|2.14||0.4356|TWO_SIDED|95.0|-2.53|5.86|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.86|-2.53|.4356
91630240|NCT02820038|183152362|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.48|STANDARD_ERROR_OF_MEAN|2.95||0.2366|TWO_SIDED|95.0|-2.3|9.26|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in self-efficacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||9.26|-2.30|0.2366
91630241|NCT02820038|183152362|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|2.29||0.8841|TWO_SIDED|95.0|-4.16|4.83|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.83|-4.16|0.8841
91630242|NCT02820038|183152362|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.3||0.5264|TWO_SIDED|95.0|-3.05|5.95|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.95|-3.05|0.5264
91630243|NCT02820038|183152363|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|2.19||0.9604|TWO_SIDED|95.0|-4.4|4.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in medication adherence at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||4.18|-4.40|0.9604
91630244|NCT02820038|183152363|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-3.62|STANDARD_ERROR_OF_MEAN|1.64||0.0279|TWO_SIDED|95.0|-6.84|-0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in adherence between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||-0.40|-6.84|0.0279
91630245|NCT02820038|183152363|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.92|STANDARD_ERROR_OF_MEAN|1.66||0.0184|TWO_SIDED|95.0|0.67|7.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in medication adherence between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||7.18|0.67|0.0184
91630246|NCT02820038|183152364|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.73||0.3056|TWO_SIDED|95.0|-2.56|8.14|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in illness intrusiveness at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||8.14|-2.56|0.3056
91665469|NCT02055547|183224148|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.74|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.74|<0.001
91792160|NCT02397564|183462158|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
91792161|NCT01848782|183462171|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.5
91665470|NCT02055547|183224148|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.81|||<|0.001|TWO_SIDED|90.0|0.75|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.75|<0.001
91665471|NCT02055547|183224149|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg vs. placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.55|||<|0.001|TWO_SIDED|90.0|0.49|0.63|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.63|0.49|<0.001
91665472|NCT02055547|183224149|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.81|0.62|<0.001
91665473|NCT02055547|183224149|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.78||||0.004|TWO_SIDED|90.0|0.69|0.89|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.89|0.69|0.004
91665474|NCT01986647|183224161|SUPERIORITY_OR_OTHER|||||||0.2691|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.2691
91665475|NCT01986647|183224162|SUPERIORITY_OR_OTHER|||||||0.6087|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.6087
91714265|NCT01656395|183320230|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.437|TWO_SIDED|95.0|-1.326|0.575|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.575|-1.326|0.437
91714266|NCT01656395|183320230|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.27|TWO_SIDED|95.0|-1.504|0.423|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.423|-1.504|0.270
91665476|NCT01986647|183224163|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0022
91665477|NCT01986647|183224164|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0344
91665478|NCT01986647|183224165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6879|TWO_SIDED|95.0|0.49|1.6|||Regression, Logistic|||||1.60|0.49|0.6879
91665479|NCT01986647|183224166|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.88||||0.5719|TWO_SIDED|95.0|0.56|1.37|||Regression, Logistic|||||1.37|0.56|0.5719
91665480|NCT01986647|183224167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.489|TWO_SIDED|95.0|0.44|5.53|||Regression, Logistic|||||5.53|0.44|0.489
91665481|NCT01986647|183224168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.2981|TWO_SIDED|95.0|0.37|26.6|||Regression, Logistic|||||26.6|0.37|0.2981
91665482|NCT01986647|183224169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9279|TWO_SIDED|95.0|0.3|3.74|||Regression, Logistic|||||3.74|0.30|0.9279
91665483|NCT01986647|183224170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.5835|TWO_SIDED|95.0|0.67|2.06|||Regression, Logistic|||||2.06|0.67|0.5835
91665484|NCT01986647|183224171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.46||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
91665485|NCT01986647|183224172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.42||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
91665486|NCT01986647|183224173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
91665487|NCT01986647|183224174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.004||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
91665488|NCT01986647|183224175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.44||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
91665489|NCT01986647|183224176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0324|TWO_SIDED|95.0|0.29|0.95|||Regression, Logistic|||||0.95|0.29|0.0324
91665490|NCT02003391|183224185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6191|||<|0.0001|ONE_SIDED|95.0||-3.8503|||ANCOVA|||||-3.8503||<0.0001
91665491|NCT03930849|183224269|OTHER||F-value for Type 3 Fixed, df=4|2.01||||0.1|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time term in a mixed methods analysis.||||||0.10
91665492|NCT03930849|183224270|SUPERIORITY||F statistic GroupxTime, df=4|0.025||||0.9|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time analysis in a mixed methods analysis.||||||0.90
91665493|NCT03930849|183224271|SUPERIORITY||F Value Group x Time, DF=4|2.12||||0.08|TWO_SIDED|||||P-value of F statistic reported below for mixed methods analysis group\*time interaction term.|Mixed Models Analysis|||||||0.08
91665494|NCT02488109|183224272|OTHER|||||||0.42||||||Changes in rates of clinical remission by group over time in the mITT model.|Regression, Linear|Clinical remission was modeled as a nominal multinomial outcome (yes, no, or missing)||The study was powered to detect a difference in 12-months clinical remission rates between groups. N = 60 per arm with 85% retention would provide 80% power on a 2-sided 0.05-level test to detect a 20% difference between groups in 12-months clinical remission rates. A generalized linear mixed-effects regression model was used to compare study arms with respect to achievement and maintenance of clinical remission.||||0.42
91630247|NCT02820038|183152364|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|4.19|STANDARD_ERROR_OF_MEAN|2.11||0.0466|TWO_SIDED|95.0|0.06|8.32|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.32|0.06|0.0466
91482896|NCT00744471|182839268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.06|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.06|<0.001
91630248|NCT02820038|183152364|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|2.11||0.9106|TWO_SIDED|95.0|-4.38|3.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.90|-4.38|0.9106
91630249|NCT02820038|183152365|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1762|TWO_SIDED|95.0|-0.57|0.1|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group..|The investigators hypothesized that participants would exhibit greater decreases in health distress at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.10|-0.57|0.1762
91630250|NCT02820038|183152365|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4186|TWO_SIDED|95.0|-0.36|0.15|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.15|-0.36|0.4186
91630251|NCT02820038|183152365|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8848|TWO_SIDED|95.0|-0.28|0.24|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.24|-0.28|0.8848
91630252|NCT02820038|183152366|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6403|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in health status at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.25|-0.15|0.6403
91630253|NCT02820038|183152366|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.8766|TWO_SIDED|95.0|-0.14|0.16|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in global health status between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.16|-0.14|0.8766
91630254|NCT02820038|183152366|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.08||0.7603|TWO_SIDED|95.0|-0.13|0.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater improvement in global health status between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.18|-0.13|0.7603
91665495|NCT02488109|183224273|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.01|TWO_SIDED|95.0|1.1|2.53||Survival analysis of time to medical stability by log-rank test, which does not assume proportional hazards. Those who did not reach medical stability before hospital discharge were censored; analyses accounted for the site effect by stratification.|Survival analysis with log rank test|Compared time to achieve medical stability by arm; participants who did not meet stability criteria by hospital discharge were right-censored||This trial was powered at 0.80 to detect a 12% to 20% difference in restored medical stability at 0.05 type I error and correlation between time points from 0.1 to 1.||2.53|1.10|0.01
91665496|NCT02488109|183224274|SUPERIORITY||Median Difference (Net)|19.0||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Cost outcomes of group differences and 95% confidence intervals were estimated.||28,819|9,293|0.002
91792162|NCT01848782|183462172|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||||0.6|-0.5|0.8
91792163|NCT01848782|183462173|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.6
91482897|NCT00744471|182839268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.17|-1.04||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.04|-2.17|<0.001
91665497|NCT03969641|183224278|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 (1-sided) and a noninferiority margin of 10%.|Difference in Proportions (RIV4 - IIV4)|-0.0214|||<|0.0001|ONE_SIDED|97.5||0.0406|||Cochran-Mantel-Haenszel|The upper bound of a Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used, stratified by site.|The directional comparison was the upper bound of the confidence interval using a 10% noninferiority margin.|The null hypothesis assumes that RIV4 is inferior (i.e., RIV4 will have a higher proportion) to IIV4 in regards to the proportion of pregnant women with adverse birth outcomes.||0.0406||<0.0001
91665498|NCT03969641|183224279|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of preterm birth was also calculated.|Odds Ratio (OR)|0.72||||0.4645|TWO_SIDED|95.0|0.35|1.48|||Mantel Haenszel|||Preterm birth||1.48|0.35|0.4645
91665499|NCT03969641|183224280|SUPERIORITY|These proportions were compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportions of combined fetal death and neonatal death was also calculated.|Odds Ratio (OR)|0.00000031||||0.2447|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Fetal or neonatal death|||0.00|0.2447
91665500|NCT03969641|183224281|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of spontaneous abortion after vaccination was also calculated. This was a subgroup analysis of only those participants vaccinated at less than 20 weeks gestational age.|Odds Ratio (OR)|0.5||||0.6235|TWO_SIDED|95.0|0.04|5.47|||Mantel Haenszel|||Spontaneous abortion||5.47|0.04|0.6235
91665501|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.17||||0.7029|TWO_SIDED|95.0|0.55|2.5|||Mantel Haenszel|||Injection Site Pain||2.50|0.55|0.7029
91525595|NCT02002884|182926407|SUPERIORITY||LS Mean difference|-0.22|||=|0.017|TWO_SIDED|95.0|-0.4|-0.04|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, Gross Motor Function Classification System-Extended and Revised (GMFCS-E\&R) level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||-0.04|-0.4|= 0.017
91665502|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|2.03||||0.6217|TWO_SIDED|95.0|0.18|22.52|||Mantel Haenszel|||Injection Site Redness||22.52|0.18|0.6217
91665503|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.7||||0.3848|TWO_SIDED|95.0|0.35|1.39|||Mantel Haenszel|||Injection Site Tenderness||1.39|0.35|0.3848
91665504|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.2504|TWO_SIDED|95.0|0.21|1.35|||Mantel Haenszel|||Nausea||1.35|0.21|0.2504
91665505|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.62||||0.5751|TWO_SIDED|95.0|0.2|1.93|||Mantel Haenszel|||Vomiting||1.93|0.20|0.5751
91482898|NCT00744471|182839269|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.13|-0.51|0.001
91665506|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.32|3.19|||Mantel Haenszel|||Diarrhea||3.19|0.32|1.0000
91665507|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.8||||1|TWO_SIDED|95.0|0.21|3.04|||Mantel Haenszel|||Abdominal Pain||3.04|0.21|1.0000
91525596|NCT02002884|182926407|SUPERIORITY||LS-Mean difference|-0.07|||=|0.546|TWO_SIDED|95.0|-0.29|0.15|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, GMFCS-E\&R level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||0.15|-0.29|= 0.546
91482899|NCT00744471|182839269|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.25|-0.64|<0.001
91630255|NCT02820038|183152367|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7093|TWO_SIDED|95.0|-0.43|0.63|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in disease activity at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.63|-0.43|0.7093
91630256|NCT02820038|183152367|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.5941|TWO_SIDED|95.0|-0.3|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.30|0.5941
91630257|NCT02820038|183152367|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9476|TWO_SIDED|95.0|-0.42|0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.40|-0.42|0.9476
91630258|NCT02820038|183152368|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.8||0.9128|TWO_SIDED|95.0|-1.65|1.48|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in depression at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.48|-1.65|0.9128
91630259|NCT02820038|183152368|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.6312|TWO_SIDED|95.0|-1.5|0.91|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.91|-1.50|0.6312
91630260|NCT02820038|183152368|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.62||0.5766|TWO_SIDED|95.0|-1.57|0.87|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.87|-1.57|0.5766
91630261|NCT02820038|183152369|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.2123|TWO_SIDED|95.0|-3.34|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in fatigue at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-3.34|0.2123
91630262|NCT02820038|183152369|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.81||0.2691|TWO_SIDED|95.0|-2.48|0.7|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.70|-2.48|0.2691
91630263|NCT02820038|183152369|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.81||0.5655|TWO_SIDED|95.0|-2.06|1.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.13|-2.06|0.5655
91665508|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.1326|TWO_SIDED|95.0|0.25|1.13|||Mantel Haenszel|||Headache||1.13|0.25|0.1326
91792164|NCT01848782|183462174|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.8
91792165|NCT01848782|183462175|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.2
91665509|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.2|5.04|||Mantel Haenszel|||Chills/Shivering||5.04|0.20|1.0000
91665510|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Body Rash|||0.00|1.0000
91665511|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.92||||1|TWO_SIDED|95.0|0.39|2.15|||Mantel Haenszel|||Malaise (Fatigue)||2.15|0.39|1.0000
91665512|NCT03969641|183224282|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.31|2.48|||Mantel Haenszel|||Myalgia (Body Aches)||2.48|0.31|1.0000
91665513|NCT03969641|183224282|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7704|TWO_SIDED|95.0|0.22|2.29|||Mantel Haenszel|||Joint Pain||2.29|0.22|0.7704
91665514|NCT02906813|183224308|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Ratio|0.631||||0.079|TWO_SIDED|90.0|0.411|0.969|||ANOVA|||Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.||0.969|0.411|0.079
91665515|NCT02906813|183224308|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.403||||0.002|TWO_SIDED|90.0|0.262|0.618|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.||0.618|0.262|0.002
91665516|NCT02906813|183224309|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.85||||0.146|TWO_SIDED|90.0|0.706|1.024|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.024|0.706|0.146
91665517|NCT02906813|183224309|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.889||||0.281|TWO_SIDED|90.0|0.738|1.07|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.070|0.738|0.281
91665518|NCT02906813|183224310|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.842||||0.191|TWO_SIDED|90.0|0.676|1.05|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.050|0.676|0.191
91665519|NCT02906813|183224310|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.894||||0.355||90.0|0.726|1.1|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.100|0.726|0.355
91665520|NCT02466087|183224319|OTHER||diiference in differences|1.5|||||TWO_SIDED|95.0|||||Regression, Linear|||||||
91665521|NCT00557245|183224322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.56||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.56|0.19|<0.001
91665522|NCT00557245|183224322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.45||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.45|0.13|<0.001
91665523|NCT00557245|183224323|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91665524|NCT00557245|183224323|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher Exact|||||||0.89
91665525|NCT00557245|183224327|SUPERIORITY_OR_OTHER|||||||0.24|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.24
91665526|NCT00557245|183224327|SUPERIORITY_OR_OTHER|||||||0.49|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.49
91792166|NCT00708201|183462178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.773|||<|0.0001|TWO_SIDED|95.0|1.359|2.311|||Wald's Chi-Square|||||2.311|1.359|<0.0001
91482900|NCT00744471|182839269|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.28|-0.66|<0.001
91482901|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
91482902|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
91630264|NCT02820038|183152370|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|4.1||0.5364|TWO_SIDED|95.0|-5.51|10.55|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in health literacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||10.55|-5.51|0.5364
91630265|NCT02820038|183152370|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|3.24||0.605|TWO_SIDED|95.0|-4.68|8.01|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.01|-4.68|0.6050
91630266|NCT02820038|183152370|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|3.24||0.924|TWO_SIDED|95.0|-6.66|6.05|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||6.05|-6.66|0.9240
91630267|NCT02820038|183152371|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7871|TWO_SIDED|95.0|0.43|1.89|||Regression, Logistic||Modeled probability of attending at least one class session. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to participate in the BetterChoices, BetterHealth program if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.89|0.43|0.7871
91630268|NCT02820038|183152371|SUPERIORITY||Odds Ratio (OR)|1.189||||0.5815|TWO_SIDED|95.0|0.643|2.198|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices,BetterHealth program if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.198|0.643|0.5815
91630269|NCT02820038|183152371|SUPERIORITY||Odds Ratio (OR)|0.679||||0.2211|TWO_SIDED|95.0|0.366|1.262|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices, BetterHealth program if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.262|0.366|0.2211
91630270|NCT02820038|183152372|SUPERIORITY||Odds Ratio (OR)|0.804||||0.574|TWO_SIDED|95.0|0.38|1.72|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to use the RA Self-Management website if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.72|0.38|0.5740
91630271|NCT02820038|183152372|SUPERIORITY||Odds Ratio (OR)|1.425||||0.1278|TWO_SIDED|95.0|0.766|2.649|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.649|0.766|0.1278
91665527|NCT00557245|183224328|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.32
91665528|NCT00557245|183224328|SUPERIORITY_OR_OTHER|||||||0.66|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.66
91665529|NCT00557245|183224329|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Regression, Logistic|Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.51
91665530|NCT00557245|183224329|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Logistic|generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.86
91665531|NCT00557245|183224330|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|linear mixed-effects model||||||0.42
91665532|NCT00557245|183224330|SUPERIORITY_OR_OTHER||Slope Difference over time|0.07||||0.08|||||||Mixed Models Analysis|Linear mixed-effects model|Placebo arm is the reference group.|||||0.08
91665533|NCT00557245|183224331|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.02
91665534|NCT00557245|183224331|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||<0.001
91665535|NCT00557245|183224332|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.35
91665536|NCT00557245|183224332|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.008
91665537|NCT01851876|183224345|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||||||0.025
91665538|NCT01630616|183224417|SUPERIORITY_OR_OTHER||Ratio (Adolescents/adults)|0.89|||||TWO_SIDED|90.0|0.62|1.26||||||||1.26|0.62|
91665539|NCT01630616|183224418|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.87|||||TWO_SIDED|90.0|0.62|1.23||||||||1.23|0.62|
91665540|NCT01630616|183224419|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.81|||||TWO_SIDED|90.0|0.57|1.16||||||||1.16|0.57|
91665541|NCT02725515|183224422|SUPERIORITY||Risk Difference (RD)|13.4||||0.183|TWO_SIDED|95.0|-6.6|32.6|||Barnard's Unconditional Exact Test P-val|||||32.6|-6.6|0.1830
91630272|NCT02820038|183152372|SUPERIORITY||Odds Ratio (OR)|0.614||||0.1278|TWO_SIDED|95.0|0.328|1.15|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.15|0.328|0.1278
91630273|NCT02820038|183152373|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|11.9|STANDARD_ERROR_OF_MEAN|8.7||0.17|TWO_SIDED|95.0|-5.2|28.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||28.9|-5.2|0.17
91630274|NCT02820038|183152373|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable|Mean Difference (Net)|16.0|STANDARD_ERROR_OF_MEAN|6.9||0.02|TWO_SIDED|95.0|2.5|29.5|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||29.5|2.5|0.02
91630275|NCT02820038|183152373|SUPERIORITY|Regression model adjusted for baseline values of the dependent variable.|Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|6.9||0.42|TWO_SIDED|95.0|-8.1|19.2|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||19.2|-8.1|0.42
91630276|NCT02820038|183152374|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.15||0.15|TWO_SIDED|95.0|-5.2|0.8|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.8|-5.2|0.15
91630277|NCT02820038|183152374|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|95.0|-4.4|0.3|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.3|-4.4|0.07
91630278|NCT02820038|183152374|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED|95.0|-4.2|0.6|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.6|-4.2|0.13
91630279|NCT02820038|183152375|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.68|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.29|-0.19|0.68
91630280|NCT02820038|183152375|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2|TWO_SIDED|95.0|-0.06|0.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.31|-0.06|0.20
91630281|NCT02820038|183152375|SUPERIORITY||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.1||0.99|TWO_SIDED|95.0|-0.19|0.19|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-week follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.19|-0.19|0.99
91482903|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
91665542|NCT02725515|183224423|SUPERIORITY||Risk Difference (RD)|17.5||||0.1075|TWO_SIDED|95.0|-3.7|37.3|||Barnard's Unconditional Exact Test P-val|||||37.3|-3.7|0.1075
91665543|NCT02725515|183224424|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0252|TWO_SIDED|95.0|0.3|0.92|||Log Rank|||||0.92|0.30|0.0252
91665544|NCT03428750|183224469|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.006
91665545|NCT03428750|183224470|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665546|NCT03428750|183224471|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.001
91665547|NCT03428750|183224472|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665548|NCT03428750|183224473|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665549|NCT03428750|183224474|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665550|NCT03428750|183224475|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665551|NCT03428750|183224476|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665552|NCT03428750|183224477|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91665553|NCT01919112|183224493|OTHER|Regression models using interaction terms will used to assess for heterogeneity of intervention effects across the novel radiological variable corticobulbar tract (CBT)-lesion load, a combined measure of lesion size and location. For purposes of the analysis, the CBT-lesion load was dichotomized into 2 groups based on the median CBT-lesion load volume.||||||0.116||||||Interaction p-values will be considered statistically significant at the 0.15 level of significance given the relatively low power for tests of interaction to detect a true interaction.|2-way analysis of variance with interact|The tDCS intervention was the main variable of interest, PAS score the main outcome and CBT-lesion load was the interaction term used.||The aim for this analysis was to assess for effect modification of the trial intervention across the novel radiological variable corticobulbar tract-lesion load.||||0.116
91665554|NCT02944617|183224495|OTHER|||||||1|||||||Fisher Exact|||||||1.00
91665555|NCT02944617|183224497|OTHER|||||||0.077|||||||Log Rank|||||||0.077
91665556|NCT00835666|183224498|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|92.6|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|92.6|
91665557|NCT00835666|183224499|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.2||||||90.0|94.7|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.7|
91665558|NCT00835666|183224500|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.4||||||90.0|94.9|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.9|
91792167|NCT00708201|183462179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-37.8|-11.5|||Log Rank|||||-11.5|-37.8|<0.001
91482904|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.11|<0.001
91665559|NCT00506831|183224577|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Null hypothesis is that the mRSS is not significantly different at month 6 compared with baseline. Paired t-test was used to compare the mean mRSS at month 6 compared with baseline.||||0.005
91665560|NCT00095784|183224596|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CD34+ cell levels. Analysis performed on log scale.||||<0.0001
91665561|NCT00095784|183224602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CXCR4 levels. Analysis performed on log scale.||||0.29
91665562|NCT00095784|183224608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in hemoglobin F levels.||||0.99
91665563|NCT00608322|183224618|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.37|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
91665564|NCT00835614|183224665|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.9||||||90.0|87.5|94.4|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94.4|87.5|
91665565|NCT00835614|183224666|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.1||||||90.0|90.3|93.9|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||93.9|90.3|
91792168|NCT00708201|183462180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|||<|0.001|TWO_SIDED|95.0|-35.0|-9.9|||Log Rank|||||-9.9|-35.0|<0.001
91630282|NCT02820038|183152376|SUPERIORITY||Odds Ratio (OR)|2.105||||0.0028|TWO_SIDED|95.0|1.291|3.432|||Regression, Logistic|||The investigators hypothesized that participants would be more likely to view at least one webpage if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Modeled probability of viewing at least one webpage. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|3.432|1.291|0.0028
91630283|NCT02820038|183152377|SUPERIORITY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.45||0.0601|TWO_SIDED|95.0|-1.71|0.04|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would view more webpages if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.04|-1.71|0.0601
91630284|NCT02820038|183152378|SUPERIORITY||Odds Ratio (OR)|0.91||||0.9|TWO_SIDED|95.0|0.22|3.81|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to be using at least one DMARD (Disease-Modifying Antirheumatic Drug) at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.81|0.22|0.90
91630285|NCT02820038|183152378|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|0.75||||0.63|TWO_SIDED|95.0|0.24|2.35|||Regression, Logistic||. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART; 1=DFB Only, DFB+SMART|The investigators hypothesized that participants would exhibit a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.35|0.24|0.63
91630286|NCT02820038|183152378|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|1.15||||0.81|TWO_SIDED|95.0|0.37|3.54|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, DrugFactsBox® (DFB) Only; 1=Other CMI+SMART, DFB+SMART|The investigators hypothesized that participants would experience a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.54|0.37|0.81
91630287|NCT03934203|183152379|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 50 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|1.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|0.2|2.4|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||2.4|0.2|
91630288|NCT03934203|183152380|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 250 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|4.4|7.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||7.1|4.4|
91630289|NCT03934203|183152381|OTHER|No formal hypotheses were tested.|Difference of adjusted means|12.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|90.0|10.5|13.6|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as moxifloxacin - placebo at 1 hour and 30 minutes after drug intake.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.6|10.5|
91665566|NCT00835614|183224667|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.2||||||90.0|90.4|94.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94|90.4|
91482905|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.57|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.57|<0.001
91665567|NCT00985439|183224737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.407|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|6.195|16.619|||ANCOVA|||||16.619|6.195|<0.001
91665568|NCT05143801|183224776|EQUIVALENCE|Main effect for environmental conditions.||||||0.003||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.003
91665569|NCT05143801|183224776|EQUIVALENCE|Main effect for mask condition.||||||0.933||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.933
91665570|NCT05143801|183224776|EQUIVALENCE|Interaction effect across environmental and mask conditions.|No Method of Estimation was used|||||0.344||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 repeated measures ANOVA|||||||0.344
91665571|NCT05143801|183224777|EQUIVALENCE|Main effect for environmental conditions.||||||0.117||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||A 2x2 repeated measures ANOVA was performed to investigate statistical differences for all variables across the four conditions. Both main and interaction effects were calculated along with effect size, reported as partial ⴄ2 as provided by the statistical software JASP (version 0.14.1.0).||||0.117
91665572|NCT05143801|183224777|EQUIVALENCE|Main effect for mask condition||||||0.832||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.832
91665573|NCT05143801|183224777|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.879||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.879
91714267|NCT01656395|183320230|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.865|TWO_SIDED|95.0|-0.839|0.997|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.997|-0.839|0.865
91630290|NCT03934203|183152382|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 2 hours after drug administration.'|Difference of adjusted means|11.9|STANDARD_ERROR_OF_MEAN|0.9||0|TWO_SIDED|90.0|10.4|13.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0167.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.4|10.4|0.00000000
91630291|NCT03934203|183152383|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 3 hours after drug administration.'|Difference of adjusted means|11.1|STANDARD_ERROR_OF_MEAN|1.0||3e-08|TWO_SIDED|90.0|9.3|12.8||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0250.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|9.3|0.00000003
91665574|NCT05143801|183224778|EQUIVALENCE|Main effect for environmental condition.||||||0.749||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.749
91665575|NCT05143801|183224778|EQUIVALENCE|Main effect for mask condition.||||||0.311||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.311
91665576|NCT05143801|183224778|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.368||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.368
91792169|NCT00708201|183462181|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91665577|NCT05143801|183224779|EQUIVALENCE|Main effect for environmental condition.||||||0.789||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.789
91665578|NCT05143801|183224779|EQUIVALENCE|Main effect for mask condition.||||||0.739||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.739
91665579|NCT05143801|183224779|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.158||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.158
91665580|NCT05143801|183224780|EQUIVALENCE|Main effect for environmental condition.||||||0.394||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.394
91665581|NCT05143801|183224780|EQUIVALENCE|Main effect for mask condition||||||0.157||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.157
91665582|NCT05143801|183224780|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.015||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.015
91792170|NCT00708201|183462182|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||<|0.01|TWO_SIDED|95.0|1.12|1.71|||Fisher Exact||This is the relative risk for being a responder (alvimopan/placebo).|||1.71|1.12|<0.01
91630292|NCT03934203|183152384|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 4 hours after drug administration.'|Difference of adjusted means|10.7|STANDARD_ERROR_OF_MEAN|1.1||2e-07|TWO_SIDED|90.0|8.9|12.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.050.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.4|8.9|0.00000020
91630293|NCT03934203|183152385|OTHER|No formal hypotheses were tested.|Difference of adjusted means|2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|1.4|3.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||3.3|1.4|
91630294|NCT03934203|183152386|OTHER|No formal hypotheses were tested.|Difference of adjusted means|11.7|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|10.6|12.8|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|10.6|
91630295|NCT03934203|183152387|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.2|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.3|-0.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 24 hours after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||-0.1|-2.3|
91630296|NCT03934203|183152388|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|-1.3|1.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 12 hours after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||1.3|-1.3|
91630297|NCT00560794|183152389|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The null hypothesis stated that the true MRD response probability (π) ≤ 5%.|1-sided exact binomial test|||||||0.0000
91630298|NCT02512276|183152421|SUPERIORITY||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|3.0|6.4||||||||6.4|3.0|
91630299|NCT02512276|183152422|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||||1.22|0.91|
91665583|NCT05143801|183224781|EQUIVALENCE|Main effect for environmental condition.||||||0.96||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.960
91665584|NCT05143801|183224781|EQUIVALENCE|Main effect for mask condition.||||||0.073||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.073
91630300|NCT02512276|183152423|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.94|1.28||||||||1.28|0.94|
91630301|NCT02512276|183152424|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.45|0.85||||||||0.85|0.45|
91630302|NCT02512276|183152425|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||||1.36|0.91|
91630303|NCT02512276|183152426|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34||||||||1.34|0.78|
91665585|NCT05143801|183224781|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.503||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.503
91665586|NCT05143801|183224782|EQUIVALENCE|Main effect for environmental condition.||||||0.786||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.786
91665587|NCT05143801|183224782|EQUIVALENCE|Main effect for mask condition.||||||0.18||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.180
91665588|NCT05143801|183224782|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.239||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.239
91665589|NCT05143801|183224783|EQUIVALENCE|Main effect for environmental condition.||||||0.134||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.134
91665590|NCT05143801|183224783|EQUIVALENCE|Main effect for mask condition.||||||0.621||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.621
91665591|NCT05143801|183224783|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.553||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.553
91665592|NCT05143801|183224784|EQUIVALENCE|Main effect for environmental condition.||||||0.461||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.461
91665593|NCT05143801|183224784|EQUIVALENCE|Main effect for mask condition.||||||0.877||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.877
91665594|NCT05143801|183224784|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.919||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.919
91665595|NCT05143801|183224785|EQUIVALENCE|Main effect for environmental condition.||||||0.466||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.466
91665596|NCT05143801|183224785|EQUIVALENCE|Main effect for mask condition.||||||0.186||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.186
91665597|NCT05143801|183224785|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.08||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.080
91665598|NCT05143801|183224786|EQUIVALENCE|Main effect for environmental condition.||||||0.375||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.375
91665599|NCT05143801|183224786|EQUIVALENCE|Main effect for mask condition.||||||0.178||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.178
91665600|NCT05143801|183224786|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.533||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.533
91665601|NCT05143801|183224787|EQUIVALENCE|Main effect for environmental condition.||||||0.29||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.290
91714268|NCT01656395|183320230|SUPERIORITY||Mean Difference (Final Values)|-0.309||||0.503|TWO_SIDED|95.0|-1.219|0.6|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.600|-1.219|0.503
91665602|NCT05143801|183224787|EQUIVALENCE|Main effect for mask condition.||||||0.527||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.527
91665603|NCT05143801|183224787|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.045||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.045
91665604|NCT05143801|183224788|EQUIVALENCE|Main effect for environmental condition.||||||0.018||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||0.018
91665605|NCT05143801|183224788|EQUIVALENCE|Main effect for mask condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||<0.001
91665606|NCT05143801|183224788|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.035||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2x3 Repeated Measures ANOVA|||||||0.035
91792171|NCT00708201|183462183|SUPERIORITY_OR_OTHER||Percent difference|-20.71|||<|0.001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for overall POM is presented.||||<0.001
91665607|NCT05143801|183224789|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
91665608|NCT05143801|183224789|EQUIVALENCE|Main effect for mask condition.||||||0.678||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.678
91665609|NCT05143801|183224789|EQUIVALENCE|Interaction effect||||||0.678|||||||2x2 Repeated Measures ANOVA|||||||0.678
91665610|NCT05143801|183224790|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
91665611|NCT05143801|183224790|EQUIVALENCE|Main effect for mask condition.||||||0.487||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.487
91665612|NCT05143801|183224790|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.79||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.790
91665613|NCT05143801|183224791|EQUIVALENCE|Main effect for environmental condition.||||||0.089||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.089
91665614|NCT05143801|183224791|EQUIVALENCE|Main effect for mask condition.||||||0.297||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.297
91665615|NCT05143801|183224791|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.111||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.111
91665616|NCT05143801|183224792|EQUIVALENCE|Main effect for environmental condition.||||||0.024||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.024
91665617|NCT05143801|183224792|EQUIVALENCE|Main effect for mask condition.||||||0.002||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.002
91482906|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.5|-1.41||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.41|-2.50|<0.001
91482907|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.65|-0.53||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.65|<0.001
91482908|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.2|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.08|-2.20|<0.001
91482909|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.56|-1.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.45|-2.56|<0.001
91482910|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-2.10|<0.001
91630304|NCT00880607|183152448|OTHER|Wilcoxon rank-sum test because the outcome variable was found to have a skewed distribution.|Median Difference (Final Values)|7.7||||0.27|TWO_SIDED|95.0|-5.8|21.2||Hodges-Lehmanne estimation method|Wilcoxon (Mann-Whitney)||Hodges-Lehmanne estimation method|||21.2|-5.8|.27
91630305|NCT00880607|183152449|OTHER|Log-rank test in Kaplan-Meier used.||||||0.42|TWO_SIDED|95.0|||||Log Rank|||||||.42
91665618|NCT05143801|183224792|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.014||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.014
91665619|NCT05143801|183224793|EQUIVALENCE|Main effect for environmental condition.||||||0.012||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.012
91482911|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.46|-1.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.25|-2.46|<0.001
91482912|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.57|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.37|-2.57|<0.001
91482913|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.75|-0.56||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.75|<0.001
91482914|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.12|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.12|<0.001
91482915|NCT00744471|182839270|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.2|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.20|<0.001
91482916|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
91482917|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
91665620|NCT05143801|183224793|EQUIVALENCE|Main effect for mask condition.||||||0.893||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.893
91630306|NCT00880607|183152451|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
91630307|NCT00880607|183152452|OTHER|||||||0.3|||||||Chi-squared|||||||0.30
91630308|NCT00880607|183152453|OTHER|||||||0.07|||||||Chi-squared|||||||0.07
91714269|NCT02318849|183320235|SUPERIORITY||Change in percentage|0.09||||0.009|TWO_SIDED||||||Mixed Models Analysis|The anaylsis was adjusted for student characteristics.||The null hypothesis was that the of number students who report being a donor (or talking to parents about organ donation) both before and after exposure to the intervention would be equivalent. A secondary null hypothesis would be that longer expsosures to the intervention over time would not increase the number who report becoming a donor at the final assessment.||||0.009
91630309|NCT00880607|183152454|OTHER|||||||0.31|||||||Chi-squared|||||||0.31
91630310|NCT02963766|183152462|SUPERIORITY||LS Mean difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.8|-0.7|||Mixed Models Analysis|||||-0.7|-1.8|<0.001
91630311|NCT02963766|183152463|SUPERIORITY||LS Mean difference (Final Values)|-1.0||||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
91630312|NCT02963766|183152463|SUPERIORITY||LS Mean difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||||-0.9|-2.2|<0.001
91630313|NCT02963766|183152464|SUPERIORITY||LS Mean difference (Final Values)|-1.44||||0.021|TWO_SIDED|95.0|-2.65|-0.22|||Mixed Models Analysis|||||-0.22|-2.65|0.021
91630314|NCT02963766|183152464|SUPERIORITY||LS Mean difference (Final Values)|-2.51|||<|0.001|TWO_SIDED|95.0|-3.72|-1.29|||Mixed Models Analysis|||||-1.29|-3.72|<0.001
91665621|NCT05143801|183224793|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.969||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.969
91665622|NCT01252953|183224794|OTHER|Time to first event|Rate Ratio|0.91||||0.004|TWO_SIDED|95.0|0.85|0.97|||Log Rank|||||0.97|0.85|0.004
91665623|NCT01252953|183224795|OTHER|Time to first event|Rate Ratio|0.93||||0.052|TWO_SIDED|95.0|0.86|1.0|||Log Rank|||||1|0.86|0.052
91665624|NCT01252953|183224796|OTHER|Time to first event|Rate Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.12||In accordance with the data analysis plan, if the outcome of a major atherosclerotic event did not reach significance, there was no hypothesis testing for presumed ischemic stroke, so no P value is given.||||||1.12|0.87|
91665625|NCT01252953|183224797|OTHER|Time to first event|Rate Ratio|0.93||||0.02|TWO_SIDED|95.0|0.88|0.99|||Log Rank|||||0.99|0.88|0.02
91665626|NCT00101439|183224804|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|0.89||||0.241|TWO_SIDED|95.0|0.73|1.08||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.08|0.73|0.241
91665627|NCT00101439|183224805|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.02||||0.812|TWO_SIDED|95.0|0.87|1.2||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.20|0.87|0.812
91665628|NCT02272803|183224825|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.41|1.67|||||Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)|||1.67|0.41|
91665629|NCT03067987|183224828|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
91665630|NCT03067987|183224829|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
91665631|NCT00829764|183224847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|93.52||||||90.0|88.49|98.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.83|88.49|
91665632|NCT00829764|183224848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.75||||||90.0|93.98|101.67|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.67|93.98|
91665633|NCT00829764|183224849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.46||||||90.0|94.78|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.28|94.78|
91665634|NCT00183196|183224859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|0.281|0.997|||Regression, Cox|||||.997|.281|
91665635|NCT00183196|183224859|SUPERIORITY|||||||0.04|||||||Regression, Cox|percent heavy drinking days at baseline was used as a covariate in the analysis as it was a predictor of overall survival independent of group.||||||0.04
91665636|NCT00385736|183224860|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.031
91665637|NCT00385736|183224860|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.833
91665638|NCT00385736|183224861|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.107
91665639|NCT00385736|183224862|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.382
91714270|NCT02318849|183320236|SUPERIORITY||Change in percentage|0.0|||>|0.1|TWO_SIDED|||||Calculated|Mixed Models Analysis|||||||>0.10
91665640|NCT00385736|183224863|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.038
91665641|NCT00385736|183224864|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.035
91665642|NCT00385736|183224865|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.080
91665643|NCT00385736|183224866|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
91665644|NCT00385736|183224867|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.526
91665645|NCT00385736|183224868|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.506
91665646|NCT00385736|183224869|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
91630315|NCT02963766|183152464|SUPERIORITY||LS Mean difference (Final Values)|-1.97|||<|0.001|TWO_SIDED|95.0|-3.03|-0.91|||Mixed Models Analysis|||||-0.91|-3.03|<0.001
91630316|NCT02963766|183152465|SUPERIORITY||Odds Ratio (OR)|11.038|||<|0.001|TWO_SIDED|95.0|3.491|34.902|||Regression, Logistic|||||34.902|3.491|<0.001
91630317|NCT02963766|183152465|SUPERIORITY||Odds Ratio (OR)|11.666|||<|0.001|TWO_SIDED|95.0|3.653|37.253|||Regression, Logistic|||||37.253|3.653|<0.001
91630318|NCT02963766|183152465|SUPERIORITY||Odds Ratio (OR)|11.348|||<|0.001|TWO_SIDED|95.0|4.163|30.932|||Regression, Logistic|||||30.932|4.163|<0.001
91630319|NCT02963766|183152466|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.689|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.689
91630320|NCT02963766|183152466|SUPERIORITY||LS Mean difference (Final Values)|0.0||||0.924|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.924
91630321|NCT02963766|183152466|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.776|TWO_SIDED|95.0|-0.6|0.4|||Mixed Models Analysis|||||0.4|-0.6|0.776
91630322|NCT00901394|183152478|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||For baseline comparisons among the three groups, one-way ANOVA was used for normally distributed variables and χ2 goodness-of-fit for categorical variables. To model the effects of B-vitamin treatment on nitrous-oxide-induced total homocysteine increase at the three different timepoints within individual patients and between the three groups, a linear mixed model with was used and we included a group × time interaction in the model.||||<0.05
91630323|NCT04964557|183152516|SUPERIORITY||Mean Difference (Final Values)|-62.3|||<|0.001|TWO_SIDED|95.0|-68.0|-56.6|||ANCOVA|||||-56.6|-68|<0.001
91630324|NCT04964557|183152517|SUPERIORITY||Mean Difference (Final Values)|-76.7|||<|0.001|TWO_SIDED|95.0|-81.7|-71.7|||ANCOVA|||||-71.7|-81.7|<0.001
91630325|NCT00323427|183152536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0974||0.69|TWO_SIDED|95.0|-0.15|0.23||No multiple testing adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.23|-0.15|0.69
91630326|NCT00323427|183152537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.42|TWO_SIDED|95.0|-0.16|0.38||No adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.38|-0.16|0.42
91630327|NCT00323427|183152538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.15||0.97|TWO_SIDED|95.0|-0.3|0.29||No adjustment|t-test, 2 sided|||H0: mean(Arm 1) = Mean (Arm 2)||0.29|-0.30|0.97
91630328|NCT02493868|183152539|SUPERIORITY||Hazard Ratio (HR)|0.49|||=|0.003|TWO_SIDED|95.0|0.29|0.84|||Weighted Log-rank|||||0.84|0.29|= 0.003
91630329|NCT05849441|183152557|SUPERIORITY|||||||0.04||||||This is for the subscale: Support-Seeking.|Regression, Linear|||||||0.04
91630330|NCT05849441|183152557|SUPERIORITY|||||||0.02||||||This is for subscale: Problem Solving|Regression, Linear|||||||0.02
91630331|NCT05849441|183152557|SUPERIORITY|||||||0.55||||||This is for subscale: Distancing|Regression, Linear|||||||0.55
91630332|NCT05849441|183152557|SUPERIORITY|||||||0.79||||||This is for subscale: Internalizing|Regression, Linear|||||||0.79
91630333|NCT05849441|183152557|SUPERIORITY|||||||0.93||||||This is for subscale: Externalizing|Regression, Linear|||||||0.93
91630334|NCT05849441|183152557|SUPERIORITY|||||||0.09||||||This is for subscale: Mindfulness|Regression, Linear|||||||0.09
91630335|NCT05849441|183152558|SUPERIORITY|||||||0.32||||||This is for subscale: Reappraisal|Regression, Linear|||||||0.32
91630336|NCT05849441|183152558|SUPERIORITY|||||||0.24||||||This is for subscale: Suppression|Regression, Linear|||||||0.24
91630337|NCT05849441|183152559|SUPERIORITY|||||||0.53||||||This is for subscale: Manage own emotions|Regression, Linear|||||||0.53
91630338|NCT05849441|183152559|SUPERIORITY|||||||0.16||||||This is for subscale: Identify and Understand Own Emotions|Regression, Linear|||||||0.16
91630339|NCT05849441|183152559|SUPERIORITY|||||||0.27||||||This is for subscale: Deal with emotions of others|Regression, Linear|||||||0.27
91630340|NCT05849441|183152559|SUPERIORITY|||||||0.59||||||This is for subscale: Perceive emotions through faces and bodies|Regression, Linear|||||||0.59
91630341|NCT05849441|183152560|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||0.16
91630342|NCT05849441|183152561|SUPERIORITY|||||||0.65||||||This is for subscale: Fear of Negative Evaluation|Regression, Linear|||||||0.65
91630343|NCT05849441|183152561|SUPERIORITY|||||||0.6||||||This is for subscale: Social avoidance and distress (new)|Regression, Linear|||||||0.60
91630344|NCT05849441|183152561|SUPERIORITY|||||||0.23||||||This is for subscale: social avoidance and distress (general)|Regression, Linear|||||||0.23
91630345|NCT05849441|183152562|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
91630346|NCT05849441|183152563|SUPERIORITY|||||||0.11||||||This is for subscale: Negativity|Regression, Linear|||||||0.11
91630347|NCT05849441|183152563|SUPERIORITY|||||||0.79||||||This is for subscale: Emotion regulation|Regression, Linear|||||||0.79
91630348|NCT05849441|183152564|SUPERIORITY|||||||0.14||||||This is for subscale: Working Memory|Regression, Linear|||||||0.14
91630349|NCT05849441|183152564|SUPERIORITY|||||||0.2||||||This is for subscale: Planning|Regression, Linear|||||||0.20
91630350|NCT05849441|183152564|SUPERIORITY|||||||0.48||||||This is for subscale: Inhibit|Regression, Linear|||||||0.48
91630351|NCT05849441|183152564|SUPERIORITY|||||||0.37||||||This is for subscale: Regulation|Regression, Linear|||||||0.37
91630352|NCT05849441|183152565|SUPERIORITY|||||||0.45|||||||Regression, Linear|||||||0.45
91630353|NCT05849441|183152566|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||0.88
91630354|NCT01431521|183152674|SUPERIORITY_OR_OTHER||Least squares mean difference|-44.37|||<|0.001|TWO_SIDED|95.0|-54.67|-34.07|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-34.07|-54.67|<0.001
91630355|NCT01431521|183152674|SUPERIORITY_OR_OTHER||Least squares mean difference|-26.67|||<|0.001|TWO_SIDED|95.0|-36.97|-16.37|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-16.37|-36.97|<0.001
91630356|NCT01431521|183152674|SUPERIORITY_OR_OTHER||least squares mean difference|-17.69||||0.007|TWO_SIDED|95.0|-36.97|-7.39|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-7.39|-36.97|0.007
91630357|NCT01431521|183152675|SUPERIORITY_OR_OTHER||Least square mean difference|-6.35|||>|0.2|TWO_SIDED|95.0|-18.69|6.0|||Linear mixed effect model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||6.00|-18.69|>0.200
91630358|NCT01431521|183152675|SUPERIORITY_OR_OTHER||Least squares mean difference|-16.74||||0.028|TWO_SIDED|95.0|-29.08|-4.4|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||-4.40|-29.08|0.028
91630359|NCT01431521|183152676|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.47|||>|0.2|TWO_SIDED|95.0|-17.85|10.92|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||10.92|-17.85|>0.200
91630360|NCT01431521|183152676|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.67|||>|0.2|TWO_SIDED|95.0|-25.06|3.71|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||3.71|-25.06|>0.200
91630361|NCT00887822|183152689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8636|TWO_SIDED|95.0|0.75|1.41|||Log Rank|The difference in distribution of survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.75|0.8636
91630362|NCT00887822|183152691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4709|TWO_SIDED|95.0|0.66|1.21|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.21|0.66|0.4709
91630363|NCT00887822|183152693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3685|TWO_SIDED|95.0|0.58|1.22|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.22|0.58|0.3685
91630364|NCT00887822|183152695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8589|TWO_SIDED|95.0|0.67|1.41|||Log Rank|The difference in distribution of disease progression between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.67|0.8589
91630365|NCT00887822|183152696|SUPERIORITY_OR_OTHER||Difference in Response Rates|7.02||||0.348|TWO_SIDED|95.0|-8.3|22.4|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||22.4|-8.3|0.3480
91630366|NCT00887822|183152697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.0462|TWO_SIDED|95.0|0.29|1.0|||Log Rank|The difference in distribution of response between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.00|0.29|0.0462
91630367|NCT00887822|183152698|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|0.45||||0.9426|TWO_SIDED|95.0|-12.4|13.3|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||13.3|-12.4|0.9426
91630368|NCT02000622|183152701|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0009|TWO_SIDED|95.0|0.43|0.8||A priori threshold for statistical significance (2-sided) is 0.05.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.||0.80|0.43|0.0009
91630369|NCT02000622|183152702|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0033|TWO_SIDED|95.0|0.4|0.83||PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.83|0.40|0.0033
91630370|NCT02000622|183152703|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5665|TWO_SIDED|95.0|0.63|1.29||OS tested using a multiple testing procedure with a recycling strategy. With 140 OS events, a priori threshold for statistical significance (2-sided) was 0.018.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.29|0.63|0.5665
91630371|NCT02000622|183152705|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.0035|TWO_SIDED|95.0|2.5|12.4|||Mixed Models Analysis|Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.|Mean difference \>0 favours olaparib.|||12.4|2.5|0.0035
91630372|NCT02000622|183152706|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.41|0.78|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.78|0.41|0.0005
91630373|NCT02000622|183152707|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.47|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.47|0.24|<0.0001
91630374|NCT02000622|183152708|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.38|0.74|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.74|0.38|0.0002
91630375|NCT02000622|183152709|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5131|TWO_SIDED|95.0|0.66|1.23||OS tested using a multiple testing procedure with a recycling strategy. With 192 OS events, a priori threshold for statistical significance was 0.045.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.23|0.66|0.5131
91630376|NCT02000622|183152710|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4167|TWO_SIDED|95.0|0.67|1.18|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.18|0.67|0.4167
91630377|NCT02000622|183152711|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.27|0.5|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.50|0.27|<0.0001
91630378|NCT02000622|183152712|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.72|0.40|<0.0001
91630379|NCT01462045|183152714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.01|TWO_SIDED|95.0|-25.6|-1.6|||t-test, 2 sided|||||-1.6|-25.6|<0.01
91630380|NCT01462045|183152715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.01|TWO_SIDED|95.0|0.83|10.8|||t-test, 2 sided|||||10.8|0.83|<0.01
91630381|NCT02045979|183152716|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 percent (%).|ratio of the geometric means|108.62|||||TWO_SIDED|90.0|98.5|119.79|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.79|98.50|
91630382|NCT02045979|183152716|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|101.27|||||TWO_SIDED|90.0|92.45|110.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.94|92.45|
91630383|NCT02045979|183152716|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|94.02|||||TWO_SIDED|90.0|86.01|102.78|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.78|86.01|
91630384|NCT02045979|183152717|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|107.32|||||TWO_SIDED|90.0|98.49|116.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||116.94|98.49|
91665647|NCT00385736|183224870|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.797
91665648|NCT00385736|183224871|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.614
91665649|NCT00385736|183224872|SUPERIORITY_OR_OTHER|||||||0.532||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.532
91665650|NCT06078501|183224893|OTHER|||||||0.695||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.695
91665651|NCT06078501|183224894|OTHER|||||||0.91|||||||Mann-Whitney U test|The a priori threshold for statistical significance was \<0.05.||||||0.91
91482918|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
91665652|NCT06078501|183224895|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
91665653|NCT06078501|183224896|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
91665654|NCT06078501|183224897|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
91665655|NCT06078501|183224898|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
91665656|NCT06078501|183224900|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91665657|NCT06078501|183224901|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||1.0
91665658|NCT06078501|183224902|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91665659|NCT03602339|183224903|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.455|||<|0.0001|TWO_SIDED|95.0|0.347|0.562||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.562|0.347|< 0.0001
91665660|NCT03602339|183224904|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.18|||=|0.0151|TWO_SIDED|95.0|0.017|0.342||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.342|0.017|= 0.0151
91665661|NCT03602339|183224905|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.15|||=|0.01|TWO_SIDED|95.0|0.024|0.275||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.275|0.024|= 0.0100
91665662|NCT03602339|183224906|NON_INFERIORITY|Non-inferiority margin is 0.35. If the lower limit of the 95% CI is \> -0.35, then non-inferiority is achieved.|Mean Difference (Final Values)|0.073|||||TWO_SIDED|95.0|-0.03|0.176||||||Difference (Gadobutrol - Gadoterate)||0.176|-0.030|
91665663|NCT03602339|183224907|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-3.4|3.4|||||The 95% confidence intervals are based on McNemar's test.|Accuracy Difference (Gadobutrol - Gadoterate)||3.40|-3.40|
91630385|NCT02045979|183152717|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|99.93|||||TWO_SIDED|90.0|92.15|108.37|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.37|92.15|
91630386|NCT02045979|183152717|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|93.66|||||TWO_SIDED|90.0|86.76|101.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.11|86.76|
91630387|NCT02045979|183152718|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|100.85|||||TWO_SIDED|90.0|95.15|106.88|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.88|95.15|
91630388|NCT02045979|183152718|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|96.39|||||TWO_SIDED|90.0|91.06|102.03|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.03|91.06|
91665664|NCT03602339|183224907|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-5.22|5.22|||||The 95% confidence intervals are based on McNemar's test.|Sensitivity Difference (Gadobutrol - Gadoterate)||5.22|-5.22|
91630389|NCT02045979|183152718|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|95.93|||||TWO_SIDED|90.0|90.83|101.33|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.33|90.83|
91630390|NCT02045979|183152719|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% Confidence Interval (CI) for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.3|||||TWO_SIDED|90.0|91.54|105.55|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.55|91.54|
91630391|NCT02045979|183152719|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|96.05|||||TWO_SIDED|90.0|89.27|103.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.36|89.27|
91630392|NCT02045979|183152719|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.11|||||TWO_SIDED|90.0|91.42|105.27|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.27|91.42|
91630393|NCT02045979|183152720|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|99.61|||||TWO_SIDED|90.0|93.66|105.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.94|93.66|
91630394|NCT02045979|183152720|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.19|||||TWO_SIDED|90.0|91.39|103.35|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.35|91.39|
91630395|NCT02045979|183152720|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.97|||||TWO_SIDED|90.0|92.58|103.68|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.68|92.58|
91665665|NCT03602339|183224907|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The 95% confidence intervals are based on McNemar's test. No continuity correction for calculation of the confidence interval was included. Zero cells lead to degenerated confidence interval.|Specificity Difference (Gadobutrol - Gadoterate)||0.00|0.00|
91630396|NCT02045979|183152721|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.23|||||TWO_SIDED|90.0|95.45|107.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||107.36|95.45|
91665666|NCT03602339|183224908|OTHER||Mean Difference (Final Values)|0.076|||||TWO_SIDED|95.0|0.011|0.14||||||Difference (Gadobutrol - Gadoterate)||0.140|0.011|
91665667|NCT03602339|183224909|OTHER||Mean Difference (Final Values)|0.0||||0.9149|TWO_SIDED|95.0|-0.1|0.11|||Wilcoxon signed-rank test|||Comparison of image quality between gadobutrol and gadoterate||0.11|-0.10|0.9149
91665668|NCT03602339|183224910|OTHER||Mean Difference (Final Values)|-0.01968|||||TWO_SIDED|95.0|-0.03491|-0.00445||||||Difference (Gadobutrol-Gadoterate) for Relative score||-0.00445|-0.03491|
91665669|NCT03602339|183224910|OTHER||Mean Difference (Final Values)|0.00586|||||TWO_SIDED|95.0|-0.00589|0.01762||||||Difference (Gadobutrol-Gadoterate) for Full image score||0.01762|-0.00589|
91630397|NCT02045979|183152721|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.83|||||TWO_SIDED|90.0|93.27|104.72|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||104.72|93.27|
91630398|NCT02045979|183152721|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.01|||||TWO_SIDED|90.0|93.15|103.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.11|93.15|
91630399|NCT02045979|183152722|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|103.68|||||TWO_SIDED|90.0|97.47|110.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.29|97.47|
91630400|NCT02045979|183152722|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.16|||||TWO_SIDED|90.0|94.37|106.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.29|94.37|
91630401|NCT02045979|183152722|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.02|||||TWO_SIDED|90.0|92.07|102.24|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.24|92.07|
91630402|NCT02045979|183152723|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|106.57|||||TWO_SIDED|90.0|99.07|114.63|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||114.63|99.07|
91665670|NCT03602339|183224910|OTHER||Mean Difference (Final Values)|0.00139|||||TWO_SIDED|95.0|-0.00471|0.00749||||||Difference (Gadobutrol-Gadoterate) for Dice score||0.00749|-0.00471|
91665671|NCT03602339|183224912|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate), and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0049||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0049
91665672|NCT03602339|183224913|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0013||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0013
91665673|NCT03602339|183224914|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0065||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0065
91482919|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.08|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.08|<0.001
91482920|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.52|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.46|-2.52|<0.001
91630403|NCT02045979|183152723|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.94|||||TWO_SIDED|90.0|94.24|108.12|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.12|94.24|
91630404|NCT02045979|183152723|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|95.37|||||TWO_SIDED|90.0|89.53|101.6|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.60|89.53|
91630405|NCT02045979|183152724|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|108.7|||||TWO_SIDED|90.0|98.54|119.9|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.90|98.54|
91630406|NCT02045979|183152724|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.36|||||TWO_SIDED|90.0|92.51|111.05|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||111.05|92.51|
91665674|NCT00829452|183224924|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.03||||||90.0|89.11|103.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.49|89.11|
91792172|NCT00708201|183462184|SUPERIORITY_OR_OTHER||Percent difference|27.05|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
91630407|NCT02045979|183152724|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|94.04|||||TWO_SIDED|90.0|86.01|102.82|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.82|86.01|
91630408|NCT04283773|183152735|SUPERIORITY||Median Difference (Final Values)|0.001|STANDARD_DEVIATION|1.5||0.001|TWO_SIDED|95.0|0.0|8.0||The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.|Kruskal-Wallis|||Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.||8|0|0.001
91630409|NCT04283773|183152736|SUPERIORITY||Hazard Ratio, log|0.009||||0.009|TWO_SIDED|95.0|0.0|8.0||Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.|Spearman's rank correlation coefficient(|||Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.||8|0|0.009
91630410|NCT04283773|183152737|SUPERIORITY|One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|1.5||0.699|TWO_SIDED|80.0|9.5|13.0||One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|ANOVA|||Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).||13|9.5|0.699
91630411|NCT03558828|183152768|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates (Cohen's d) for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator.||"The longitudinal trajectories using generalized estimating equations (GEEs) were estimated. Cases for responders are duplicated and weighted based on the inverse probability of being assigned to a particular adaptive intervention (i.e., responders have a ½ probability of assignment to a specific adaptive intervention, and non-responders have a ¼ probability).~Only the Phase 1 (baseline to 8 weeks) treatment condition x time interaction was included because it preceded the randomization to Phase 2 (weeks 9-34) treatment conditions. Planned contrasts were used to test specific hypotheses. Effect size estimates for all analyses were created by using the relevant slope effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests."|||
91630412|NCT03558828|183152769|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. An estimated effect size of d=0.41 was used.||There were time slope terms for Phase 1 (baseline to 8-week assessment), Phase 2 (9-weeks to 34-week assessment), and Phase 3 (maintenance from 35-weeks to 50-week assessment). Also, there were interactions of condition and time slopes. For Phase 1, only the Phase 1 treatment condition x time interaction was included because it preceded the randomization to Phase 2 treatment conditions. Supplementary analyses were conducted to compare the trajectories of responders versus non-responders to the Phase 1 treatment. Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. The resulting effect size is equivalent to a Cohen's d, representing mean change (or difference in change) in standard deviation units. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|||
91630413|NCT03671148|183152792|SUPERIORITY||Response Rate Difference|24.5|||<|0.001|TWO_SIDED|95.0|15.9|33.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of current use of csDMARD (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% BSA or \< 3% BSA) at Baseline.||33.0|15.9|<0.001
91630414|NCT03671148|183152793|SUPERIORITY||Least Squares (LS) Mean Difference|-0.16|||<|0.001|TWO_SIDED|95.0|-0.26|-0.07||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.07|-0.26|<0.001
91630415|NCT03671148|183152794|SUPERIORITY||Response Rate Difference|44.3|||<|0.001|TWO_SIDED|95.0|33.9|54.6||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.6|33.9|<0.001
91630416|NCT03671148|183152795|SUPERIORITY||Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|13.9|31.2||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||31.2|13.9|<0.001
91630417|NCT03671148|183152796|SUPERIORITY||Response Rate Difference|14.0|||<|0.001|TWO_SIDED|95.0|7.0|21.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||21.0|7.0|<0.001
91630418|NCT03671148|183152797|SUPERIORITY||LS Mean Difference|3.86|||<|0.001|TWO_SIDED|95.0|2.41|5.31||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||5.31|2.41|<0.001
91630419|NCT03671148|183152798|SUPERIORITY||LS Mean Difference|2.2||||0.009|TWO_SIDED|95.0|0.6|3.9||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.9|0.6|0.009
91630420|NCT03671148|183152799|SUPERIORITY||Response Rate Difference|16.6|||<|0.001|TWO_SIDED|95.0|9.7|23.6|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||23.6|9.7|<0.001
91630421|NCT03671148|183152800|SUPERIORITY||Response Rate Difference|6.0||||0.024|TWO_SIDED|95.0|0.8|11.3|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||11.3|0.8|0.024
91630422|NCT03671148|183152801|SUPERIORITY||Response Rate Difference|13.8||||0.009|TWO_SIDED|95.0|3.5|24.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||24.2|3.5|0.009
91630423|NCT03671148|183152802|SUPERIORITY||Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|22.9|54.8|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.8|22.9|<0.001
91630424|NCT00425945|183152804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-0.1|14.9||||||||14.9|-0.1|
91630425|NCT00425945|183152805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-2.1|10.8||||||||10.8|-2.1|
91630426|NCT00425945|183152806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-1.7|2.5||||||||2.5|-1.7|
91665675|NCT00829452|183224925|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.34||||||90.0|90.82|100.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.09|90.82|
91665676|NCT00829452|183224926|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.98||||||90.0|92.73|101.42|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.42|92.73|
91665677|NCT00829452|183224927|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.78||||||90.0|89.34|109.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||109.23|89.34|
91630427|NCT00425945|183152807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.2|||||TWO_SIDED|95.0|-2.3|38.7||||||||38.7|-2.3|
91630428|NCT00425945|183152808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
91630429|NCT00425945|183152809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|-0.0|
91630430|NCT00425945|183152810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-6.8|0.5||||||||0.5|-6.8|
91630431|NCT00425945|183152811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||||0.5|-1.5|
91630432|NCT00425945|183152812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|0.0|0.4||||||||0.4|0.0|
91630433|NCT00425945|183152813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.1|2.4||||||||2.4|0.1|
91630434|NCT00425945|183152814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.4|2.3||||||||2.3|-4.4|
91630435|NCT00425945|183152815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||||2.5|-0.9|
91630436|NCT00425945|183152816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
91630437|NCT00425945|183152817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.3||||||||9.3|-1.6|
91630438|NCT00425945|183152818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8||||||||0.8|-3.4|
91630439|NCT05618808|183152842|SUPERIORITY||Posterior Odds Ratio|0.78|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
91630440|NCT05618808|183152845|SUPERIORITY||Posterior Odds Ratio|0.44|||||TWO_SIDED|90.0|0.16|1.61|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.61|0.16|
91630441|NCT05618808|183152846|SUPERIORITY||Posterior Odds Ratio|0.79|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
91630442|NCT05618808|183152852|SUPERIORITY||Posterior Odds Ratio|0.54|||||TWO_SIDED|90.0|0.32|0.95|||||Enoxaparin vs Apixaban||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|0.95|0.32|
91630443|NCT02527564|183152853|OTHER|||||||0.1||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.10
91630444|NCT02527564|183152853|OTHER|||||||0.57||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1- placebo (double-blind) group||||0.57
91630445|NCT02527564|183152853|OTHER|||||||0.44||||||A p-value of \<0.05 would be considered statistically significant.|Unpaired 2-sided t-test|||Between group change at week 1||||0.44
91630446|NCT02527564|183152854|OTHER|||||||0.035||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.035
91630447|NCT02527564|183152854|OTHER|||||||0.55|||||||Paired 2-sided t-test|A p-value of \<0.05 would be considered statistically significant.||Within group change at week 1- placebo (double-blind) group||||0.55
91630448|NCT02527564|183152854|OTHER|||||||0.89||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Between group change at week 1||||0.89
91630449|NCT02527564|183152855|OTHER|||||||0.97||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.97
91665678|NCT00829452|183224928|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.59||||||90.0|94.62|100.66|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.66|94.62|
91630450|NCT02527564|183152856|OTHER|||||||0.28||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.28
91630451|NCT01804842|183152857|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.7||||0.0018|TWO_SIDED|90.0|61.14|84.01|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||84.01|61.14|0.0018
91630452|NCT01804842|183152857|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.5||||0.002|TWO_SIDED|90.0|60.85|84.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||84.09|60.85|0.0020
91630453|NCT01804842|183152857|SUPERIORITY_OR_OTHER||% Ratio of LS Means|99.8||||0.9844|TWO_SIDED|90.0|84.91|117.33|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||117.33|84.91|0.9844
91630454|NCT01804842|183152858|SUPERIORITY_OR_OTHER||% Ratio of LS Means|83.8||||0.1595|TWO_SIDED|90.0|68.1|103.23|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of LS means and the comparator for the p-values.||103.23|68.10|0.1595
91630455|NCT01804842|183152858|SUPERIORITY_OR_OTHER||% Ratio of LS Means|111.3||||0.3867|TWO_SIDED|90.0|90.37|136.99|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||136.99|90.37|0.3867
91630456|NCT01804842|183152858|SUPERIORITY_OR_OTHER||% Ratio of LS Means|132.7||||0.0294|TWO_SIDED|90.0|107.78|163.39|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||163.39|107.78|0.0294
91630457|NCT01804842|183152859|SUPERIORITY_OR_OTHER||% Ratio of LS Means|91.0||||0.0028|TWO_SIDED|95.0|85.7|96.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.67|85.70|0.0028
91630458|NCT01804842|183152859|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.9||||0.0024|TWO_SIDED|95.0|85.58|96.53|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.53|85.58|0.0024
91630459|NCT01804842|183152859|SUPERIORITY_OR_OTHER||% Ratio of LS Means|95.1||||0.0992|TWO_SIDED|95.0|89.54|100.99|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||100.99|89.54|0.0992
91630460|NCT01804842|183152860|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.4||||0.0006|TWO_SIDED|95.0|85.55|95.56|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.56|85.55|0.0006
91665679|NCT02615249|183224929|OTHER||Kappa statistic|0.28|||||TWO_SIDED|95.0|-0.01|0.58||||||Comparison between 0.12 mg/cm2 copper sulfate and copper sulfate 2% in petrolatum||0.58|-0.01|
91630461|NCT01804842|183152860|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.5||||0.0007|TWO_SIDED|95.0|85.65|95.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.67|85.65|0.0007
91630462|NCT01804842|183152860|SUPERIORITY_OR_OTHER||% Ratio of LS Means|94.3||||0.0389|TWO_SIDED|95.0|89.24|99.69|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||99.69|89.24|0.0389
91630463|NCT00628134|183152861|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.07
91630464|NCT00628134|183152862|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.29
91630465|NCT02365506|183152863|SUPERIORITY||Difference in LSM|-7.7|STANDARD_ERROR_OF_MEAN|7.92||0.358|TWO_SIDED|95.0|-26.0|10.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|Least Square mean (LSM) and 95% confidence interval (CI) is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||10.5|-26.0|0.358
91630466|NCT02365506|183152863|SUPERIORITY||Difference in LSM|-1.7|STANDARD_ERROR_OF_MEAN|7.96||0.84|TWO_SIDED|95.0|-20.0|16.7|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||16.7|-20.0|0.840
91630467|NCT02365506|183152864|SUPERIORITY||Difference in LSM|-6.0|STANDARD_ERROR_OF_MEAN|5.83||0.338|TWO_SIDED|95.0|-19.8|7.8|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||7.8|-19.8|0.338
91630468|NCT02365506|183152864|SUPERIORITY||Difference in LSM|5.3|STANDARD_ERROR_OF_MEAN|6.21||0.425|TWO_SIDED|95.0|-9.4|19.9|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||19.9|-9.4|0.425
91630469|NCT02365506|183152865|SUPERIORITY||Difference in LSM|-6.5|STANDARD_ERROR_OF_MEAN|4.42||0.174|TWO_SIDED|95.0|-16.5|3.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||3.5|-16.5|0.174
91665680|NCT02615249|183224929|OTHER||Kappa statistic|0.45|||||TWO_SIDED|95.0|0.24|0.66||||||Comparison between 0.24 mg/cm2 manganese chloride and manganese chloride 2% in petrolatum||0.66|0.24|
91665681|NCT02615249|183224929|OTHER||Kappa statistic|0.23|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.33 mg/cm2 tin chloride vs 1% tin chloride in petrolatum reference allergen|Comparison between 0.33 mg/cm2 tin chloride and tin chloride 1% in petrolatum||0.38|0.07|
91665682|NCT02615249|183224929|OTHER||Kappa statistic|0.4|||||TWO_SIDED|95.0|0.15|0.65|||||Kappa statistic is for 0.22 mg Ti/cm2 ammonium titanium oxide oxalate vs 19% ammonium titanium oxide oxalate in petrolatum reference allergen|Comparison between 0.22 mg Ti/cm2 ammonium titanium oxide oxalate and ammnium titanium oxide oxalate 19% in petrolatum||0.65|0.15|
91665683|NCT02615249|183224929|OTHER||Kappa statistic|0.52|||||TWO_SIDED|95.0|0.3|0.73|||||Kappa statistic is for 0.050 mg V/cm2 vanadium sulfate vs 1.5% vanadium sulfate in petrolatum reference allergen|Comparison between 0.050 mg/cm2 vanadium sulfate and vanadium sulfate 1.5% in petrolatum||0.73|0.30|
91630470|NCT02365506|183152865|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|4.28||0.448|TWO_SIDED|95.0|-6.3|13.1|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||13.1|-6.3|0.448
91630471|NCT02365506|183152866|SUPERIORITY||Difference in LSM|8.8|STANDARD_ERROR_OF_MEAN|8.5||0.339|TWO_SIDED|95.0|-12.0|29.6|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||29.6|-12.0|0.339
91630472|NCT02365506|183152866|SUPERIORITY||Difference in LSM|12.8|STANDARD_ERROR_OF_MEAN|8.4||0.178|TWO_SIDED|95.0|-7.7|33.4|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||33.4|-7.7|0.178
91665684|NCT02615249|183224929|OTHER||Kappa statistic|0.36|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.24 mg/cm2 zinc chloride vs 2% zinc chloride in petrolatum reference allergen|Comparison betweenm 0.24 mg/cm2 zinc chloride and zinc chloride 2% in petrolatum||0.38|0.07|
91630473|NCT02365506|183152867|SUPERIORITY||Difference in LSM|4.9|STANDARD_ERROR_OF_MEAN|8.03||0.564|TWO_SIDED|95.0|-14.1|23.9|||Mixed Models Analysis|||||23.9|-14.1|0.564
91630474|NCT02365506|183152867|SUPERIORITY||Difference in LSM|2.7|STANDARD_ERROR_OF_MEAN|7.38||0.721|TWO_SIDED|95.0|-14.7|20.2|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||20.2|-14.7|0.721
91665685|NCT01087502|183224976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.24|||ANCOVA|||||-0.24|-0.60|<0.0001
91665686|NCT01087502|183224978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|STANDARD_ERROR_OF_MEAN|6.59||0.1602||95.0|-22.28|3.7|||ANCOVA|||||3.7|-22.28|0.1602
91792173|NCT00708201|183462185|SUPERIORITY_OR_OTHER||Percent difference|25.2|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
91630475|NCT03774875|183152871|SUPERIORITY||Adjusted Difference in Response Rates|31.9|STANDARD_ERROR_OF_MEAN|6.78|<|0.0001|TWO_SIDED|95.0|18.6|45.2|||Cochran-Mantel-Haenszel|The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (apremilast - placebo) in response rates calculated using the weighted average of the treatment differences across the strata with the CMH weights.|||45.2|18.6|<0.0001
91630476|NCT03774875|183152872|SUPERIORITY||Least Squares (LS) Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|-7.15|-3.43|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.|Difference in LS Means = Apremilast - Placebo|||-3.43|-7.15|<0.0001
91630477|NCT03774875|183152873|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|14.12||0.0085|TWO_SIDED|95.0|-66.58|-10.14|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.|LS Mean Difference = Apremilast - Placebo|||-10.14|-66.58|0.0085
91630478|NCT03774875|183152874|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.34|-0.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-0.86|-2.34|<0.0001
91630479|NCT03774875|183152875|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|4.31||0.0003|TWO_SIDED|95.0|-24.63|-7.6|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-7.60|-24.63|0.0003
91630480|NCT03774875|183152876|SUPERIORITY||Adjusted Difference in Response Rates|13.5|STANDARD_ERROR_OF_MEAN|6.3||0.0328|TWO_SIDED|95.0|1.1|25.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.|The adjusted difference in response rates (Apremilast - Placebo) using the weighted average of the treatment differences across the strata with the CMH weights.|||25.8|1.1|0.0328
91630481|NCT03774875|183152877|SUPERIORITY||Adjusted Difference in Response Rates|37.0|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|24.1|49.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (Apremilast - Placebo) in response rates using the weighted average of the treatment differences across the strata with the CMH weights.|||49.9|24.1|<0.0001
91630482|NCT03774875|183152878|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|18.55||0.4216|TWO_SIDED|95.0|-21.62|51.48|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||51.48|-21.62|0.4216
91630483|NCT03774875|183152879|SUPERIORITY||LS Mean Difference|-148.024|STANDARD_ERROR_OF_MEAN|103.9525||0.1559|TWO_SIDED|95.0|-352.8793|56.8304|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||56.8304|-352.8793|0.1559
91630484|NCT03774875|183152880|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.82||0.2667|TWO_SIDED|95.0|-2.43|8.73|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.73|-2.43|0.2667
91630485|NCT03774875|183152881|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.23||0.562|TWO_SIDED|95.0|-10.83|5.91|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||5.91|-10.83|0.5620
91665687|NCT01151618|183224984|OTHER|"Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):~Sensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M\&W) \* 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M\&W) \* 100"|DeltaXrs (cmH2O*s/L)|2.6|||||TWO_SIDED|90.0|0.0|100.0|||||DeltaXrs equals average inspiratory reactance minus average expiratory reactance.|||100|0|
91665688|NCT03105297|183225079|SUPERIORITY|||||||0.0147||95.0||||p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment \& period as fixed effects, participants as random effects \& time as repeated measures effect.|ANCOVA|||||||0.0147
91665689|NCT03105297|183225080|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
91665690|NCT03105297|183225081|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
91665691|NCT03105297|183225082|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||p-values are from a one sample t-test using SAS (Statistical Analysis System) UNIVARIATE on change from baseline.|t-test, 1 sided|||||||0.0073
91630486|NCT03774875|183152882|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|4.81||0.8927|TWO_SIDED|95.0|-10.16|8.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.86|-10.16|0.8927
91630487|NCT03774875|183152883|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|4.09||0.0572|TWO_SIDED|95.0|-15.9|0.24|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||0.24|-15.90|0.0572
91630488|NCT02352090|183152909|OTHER|||||||0.27|||||||ANOVA|||||||0.27
91630489|NCT05179057|183153008|SUPERIORITY|A logistic regression model included treatment, level of viremia at baseline (≥10,000 copies/mL or \<10,000 copies/mL adenovirus DNA), age (≥12 years or \<12 years), and absolute lymphocyte counts at baseline. The null hypothesis is that the true percentage for posoleucel plus SoC is less than or equal to the true percentage for placebo plus SoC, and the alternative hypothesis is that it is greater.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.26|3.69|||||Posoleucel versus Placebo|||3.69|0.26|
91665692|NCT00714051|183225105|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Chi-squared|||The number of participants who fell on the tripping trial in each group were compared using Chi-square analysis||||0.45
91665693|NCT01390948|183225130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.1292|TWO_SIDED|95.0|0.9|2.3|||Log Rank|||||2.30|0.90|0.1292
91665694|NCT05740098|183225161|SUPERIORITY||Odds Ratio (OR)|5.378|||<|0.001|TWO_SIDED|95.0|2.278|12.689|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||12.689|2.278|<0.001
91792174|NCT00708201|183462186|SUPERIORITY_OR_OTHER||Percent difference|-6.94||||0.0946|TWO_SIDED|95.0|-14.5|0.62|||Fisher Exact||Percent difference = alvimopan - placebo.|||0.62|-14.5|0.0946
91630490|NCT03375203|183153035|OTHER||Back-transformed Least Square Mean Ratio|0.88|||=|0.346|TWO_SIDED|90.0|0.7|1.1|||ANCOVA|||||1.10|0.70|= 0.346
91630491|NCT03375203|183153035|OTHER||Back-transformed Least Square Mean Ratio|0.64|||=|0.001|TWO_SIDED|90.0|0.51|0.81|||ANCOVA|||||0.81|0.51|= 0.001
91630492|NCT03375203|183153035|OTHER||Back-transformed Least Square Mean Ratio|0.51|||<|0.001|TWO_SIDED|90.0|0.41|0.64|||ANCOVA|||||0.64|0.41|< 0.001
91630493|NCT03375203|183153035|OTHER|||||||0|||||||MCP-mod|||||||0.000
91630494|NCT03107793|183153082|SUPERIORITY||||||=|0.0871|||||||Cochran-Mantel-Haenszel|||||||= 0.0871
91630495|NCT02808507|183153119|OTHER||Treatment initiation ratio|1.04||||0.73|TWO_SIDED|95.0|0.8|1.3|||See above comments|||The primary analysis was based on the facility-level rate ratio. We first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% CI. We first fit a Poisson regression to the facility-level counts and the district and historical volume covariates. The residuals ratios, calculated as the ratio of the observed over the expected counts, were then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.||1.3|0.80|0.73
91630496|NCT02808507|183153120|OTHER||Treatment initiation ratio|1.05||||0.68|TWO_SIDED|95.0|0.97|1.13|||Poisson regression||Adjusted for district, study phase and clinic random effect.|The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics during the two study periods, excluding the six-month washout period. The number of people starting treatment for incident TB was calculated by performing a review of paper and electronic medical records at each clinic on a quarterly basis during the study.||1.13|0.97|0.68
91665695|NCT05740098|183225161|SUPERIORITY||Odds Ratio (OR)|3.668||||0.003|TWO_SIDED|95.0|1.538|8.747|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||8.747|1.538|0.003
91665696|NCT05740098|183225161|SUPERIORITY||Odds Ratio (OR)|0.682||||0.256|TWO_SIDED|95.0|0.352|1.321|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||1.321|0.352|0.256
91665697|NCT05740098|183225161|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on 7-day point prevalence abstinence at 12- and 24-week assessments||||<0.001
91665698|NCT05740098|183225162|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.365||0.287|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.287
91665699|NCT05740098|183225162|SUPERIORITY||Mean Difference (Final Values)|-0.597|STANDARD_ERROR_OF_MEAN|0.369||0.108|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.108
91665700|NCT05740098|183225162|SUPERIORITY||Mean Difference (Final Values)|-0.987|STANDARD_ERROR_OF_MEAN|0.361||0.007|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.007
91665701|NCT05740098|183225162|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on Child Urine Cotinine||||0.878
91630497|NCT02808507|183153121|OTHER||Prevalence ratio|1.0||||0.8|TWO_SIDED|95.0|0.51|1.95||"The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts (secondary cases) by arm."|Poisson regression||Adjusted for study phase and district|||1.95|0.51|0.80
91630498|NCT02040857|183153139|OTHER|Exact binomial test||||||0.0011|||||||Exact binomial test|||Primary objective is treatment discontinuation rate at 2 yr for patients receiving Palbociclib therapy. If the true rate of discontinuation by two years is 48% or higher, treatment duration will be considered not feasible and not worthy of further study. If the rate of discontinuation is 33.3% or less, the 2 yr duration will be deemed feasible and worthy of further study. Using a one-sided alpha = 0.025, there is \> 90% power to reject the null hypothesis in favor of feasibility.||||0.0011
91665702|NCT05740098|183225163|SUPERIORITY||Chi-Square Test Statistic|6.909||||0.009|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.009
91665703|NCT05740098|183225163|SUPERIORITY||Chi-Square Test Statistic|4.287||||0.038|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.038
91630499|NCT00976963|183153145|NON_INFERIORITY|The equivalence margin for non-inferiority of Fosfomycin to TMP/SMX is 10%.|||||<|0.001|||||||Wald test for noninferiority|||The null hypothesis is that Fosfomycin is inferior to TMP/SMX.||||<0.001
91665704|NCT05740098|183225163|SUPERIORITY||Chi-Square Test Statistic|0.392||||0.531|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.531
91665705|NCT05740098|183225164|SUPERIORITY||Chi-Square Test Statistic|3.859||||0.145|TWO_SIDED||||||Chi-squared|Degrees of freedom = 2||Analysis tested for significant main effect of treatment condition on 7-day point prevalence abstinence at 48-week follow-up||||0.145
91665706|NCT05740098|183225165|SUPERIORITY||Wald Chi-Square Test Statistic|1.454||||0.228|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 6-weeks following quit date adjusting for treatment condition.||||0.228
91665707|NCT05740098|183225165|SUPERIORITY||Wald Chi-Square Test Statistic|2.7||||0.1|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 12-weeks following quit date adjusting for treatment condition.||||0.10
91630500|NCT00608842|183153147|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
91630501|NCT00608842|183153147|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
91630502|NCT00608842|183153147|SUPERIORITY_OR_OTHER||Difference to placebo|7.1|||||TWO_SIDED|95.0|-12.2|31.5||||||Complete Clearance||31.5|-12.2|
91665708|NCT05740098|183225165|SUPERIORITY||Wald Chi-Square Test Statistic|3.202||||0.074|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 24-weeks following quit date adjusting for treatment condition.||||0.074
91665709|NCT05740098|183225165|SUPERIORITY||Wald Chi-Square Test Statistic|0.491||||0.484|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 48-weeks following quit date adjusting for treatment condition.||||0.484
91665710|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|1.063||||0.302|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 6-weeks following quit date||||0.302
91665711|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.788||||0.375|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 12-weeks following quit date||||0.375
91482921|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.54|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.54|<0.001
91482922|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.71|-0.63||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.63|-1.71|<0.001
91482923|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.21|-1.12||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.12|-2.21|<0.001
91482924|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.6|-1.52||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.52|-2.60|<0.001
91482925|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.11|-0.99||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.99|-2.11|<0.001
91482926|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.45|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.32|-2.45|<0.001
91482927|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.82|-1.7||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.70|-2.82|<0.001
91482928|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.82|-0.71||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.71|-1.82|<0.001
91482929|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.15|-1.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.03|-2.15|<0.001
91482930|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.51|-1.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.40|-2.51|<0.001
91630503|NCT00608842|183153147|SUPERIORITY_OR_OTHER||Difference to placebo|1.6|||||TWO_SIDED|95.0|-23.0|27.5||||||≥ 75% Cleared||27.5|-23.0|
91665712|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.08||||0.777|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 24-weeks following quit date||||0.777
91630504|NCT00608842|183153147|SUPERIORITY_OR_OTHER||Difference to placebo|-5.1|||||TWO_SIDED|95.0|-28.3|19.6||||||≥ 75% Cleared||19.6|-28.3|
91630505|NCT00608842|183153147|SUPERIORITY_OR_OTHER||Difference to placebo|2.5|||||TWO_SIDED|95.0|-22.3|29.5||||||≥ 75% Cleared||29.5|-22.3|
91630506|NCT01024920|183153153|OTHER|||||||0.8531||||||P-value for comparison of Kaplan-Meier estimates at 9 months using normal approximation test (two-sided).|Normal approximation test|||||||0.8531
91630507|NCT01024920|183153155|OTHER||Hazard Ratio (HR)|1.12||||0.6395|TWO_SIDED|95.0|0.697|1.8|||Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery.|A stratified log-rank test (two-sided, 0.05 significance level) was used to test the effect of nintedanib on PFS compared with sunitinib. The test was stratified by Motzer risk score category (low/intermediate or high) and prior nephrectomy surgery for Renal Cell Cancer (yes or no).||1.800|0.697|0.6395
91665713|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.006||||0.937|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 48-weeks following quit date||||0.937
91630508|NCT01024920|183153156|OTHER||Odds Ratio (OR)|0.484||||0.1213|TWO_SIDED|95.0|0.193|1.212|||Regression, Logistic||Odds ratio \> 1 favours nintedanib.|A logistic regression model stratified by Motzer risk score category and prior surgery for renal cell cancer (RCC) was used to compare the objective response rate between the two treatment arms. The corresponding odds ratio and 95% Confidence Intervals was also presented.||1.212|0.193|0.1213
91630509|NCT01024920|183153158|OTHER||Hazard Ratio (HR)|0.92||||0.7593|TWO_SIDED|95.0|0.542|1.564||P-value from log-rank stratified by Motzer risk score and previous surgery.|Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.564|0.542|0.7593
91482931|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.85|-0.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.85|<0.001
91482932|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.15|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.15|<0.001
91482933|NCT00744471|182839271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.4|-1.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.27|-2.40|<0.001
91482934|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
91482935|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
91482936|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
91482937|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.12|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.12|<0.001
91482938|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.64|-1.6||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.60|-2.64|<0.001
91482939|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.46|-1.43||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.43|-2.46|<0.001
91482940|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.72|-0.64||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.64|-1.72|<0.001
91482941|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.18|-1.09||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.09|-2.18|<0.001
91482942|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.43|-1.35||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.35|-2.43|<0.001
91482943|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.93|-0.77||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.77|-1.93|<0.001
91482944|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.31|-1.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.15|-2.31|<0.001
91482945|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.47|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.32|-2.47|<0.001
91482946|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.52|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-1.52|<0.001
91482947|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.91|-0.78||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.78|-1.91|<0.001
91482948|NCT00744471|182839272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.09|-0.97||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.97|-2.09|<0.001
91482949|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
91482950|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
91792175|NCT01933789|183462200|SUPERIORITY||Probit regression coefficient|1.145|||<|0.001|TWO_SIDED|95.0|0.844|1.446||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.446|0.844|<0.001
91792176|NCT01933789|183462201|SUPERIORITY||Probit regression coefficient|1.251|||<|0.001|TWO_SIDED|95.0|0.92|1.583||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.583|0.920|<0.001
91792177|NCT01933789|183462202|SUPERIORITY||Probit regression coefficient|1.381|||<|0.001|TWO_SIDED|95.0|1.046|1.715||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.715|1.046|<0.001
91792178|NCT01933789|183462204|SUPERIORITY||Probit regression coefficient|0.334||||0.073|TWO_SIDED|95.0|-0.031|0.699||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|Occurrence of goal-concordant care||0.699|-0.031|0.073
91792179|NCT01933789|183462205|SUPERIORITY||Probit regression coefficient|0.481||||0.017|TWO_SIDED|95.0|0.085|0.877||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|||0.877|0.085|0.017
91792180|NCT01933789|183462206|SUPERIORITY||Probit regression coefficient|2.022||||0.01|TWO_SIDED|95.0|0.476|3.569||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the latent variable as measured at baseline.|Control group coded 0; intervention group coded 1.|||3.569|0.476|0.010
91792181|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|2.209||||0.001|TWO_SIDED|95.0|0.939|3.479||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.479|0.939|0.001
91792182|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|1.237||||0.122|TWO_SIDED|95.0|-0.33|2.804||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||2.804|-0.330|0.122
91792183|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|2.329||||0.098|TWO_SIDED|95.0|-0.426|5.083||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.083|-0.426|0.098
91792184|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|1.573||||0.352|TWO_SIDED|95.0|-1.742|4.887||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Adjusted for outcome variable as measured at baseline: pt. minority status, education, income; clinician type \& specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect."||4.887|-1.742|0.352
91792185|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|4.625|||<|0.001|TWO_SIDED|95.0|2.06|7.19||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect."||7.190|2.060|<0.001
91792186|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|2.404||||0.002|TWO_SIDED|95.0|0.898|3.909||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.909|0.898|0.002
91792187|NCT01933789|183462207|SUPERIORITY||Tobit regression coefficient|2.455||||0.075|TWO_SIDED|95.0|-0.25|5.159||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician type.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.159|-0.250|0.075
91792188|NCT01933789|183462208|SUPERIORITY||Probit regression coefficient|-0.103||||0.369|TWO_SIDED|95.0|-0.327|0.122||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent depression variable and for the patient racial/ethnic minority status.|Control group coded 0; intervention group coded 1.|Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.||0.122|-0.327|0.369
91630510|NCT01024920|183153159|OTHER||Cox Proportional Hazard|1.143||||0.5958|TWO_SIDED|95.0|0.697|1.873|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery.|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.873|0.697|0.5958
91630511|NCT01024920|183153160|OTHER||Hazard Ratio (HR)|1.142||||0.5712|TWO_SIDED|95.0|0.72|1.812|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery (two-sided).|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.812|0.720|0.5712
91630512|NCT01791465|183153202|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91630513|NCT01791465|183153203|SUPERIORITY_OR_OTHER|||||||0.34||||||Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison|Wilcoxon (Mann-Whitney)|no adjustments||The null hypothesis was that there would be no difference between baseline and 16 week IL-6||||0.34
91630514|NCT01791465|183153204|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
91630515|NCT01791465|183153205|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91630516|NCT01791465|183153206|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91792189|NCT01933789|183462209|SUPERIORITY||Probit regression coefficient|0.263||||0.536|TWO_SIDED|95.0|-0.571|1.097||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score.|Control group coded 0; intervention group coded 1.|Symptoms of depression: standard PHQ-8 composite score.||1.097|-0.571|0.536
91630517|NCT01791465|183153207|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91630518|NCT01791465|183153208|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91630519|NCT01791465|183153209|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91630520|NCT01791465|183153210|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91630521|NCT01791465|183153211|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91630522|NCT01791465|183153212|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91630523|NCT01791465|183153213|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91630524|NCT01791465|183153214|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91792190|NCT01933789|183462210|SUPERIORITY||Probit regression coefficient|0.208||||0.106|TWO_SIDED|95.0|-0.044|0.461||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Pts clustered under clins. Adjusted for baseline level of the latent depression var; pt age, minority status, education, health status; clin specialty|Control group coded 0; intervention group coded 1.|Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.461|-0.044|0.106
91792191|NCT01933789|183462211|SUPERIORITY||Probit regression coefficient|0.446||||0.343|TWO_SIDED|95.0|-0.476|1.368||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score and clinician specialty.|Control group coded 0; intervention group coded 1.|Symptoms of depression: Standard PHQ-8 composite score||1.368|-0.476|0.343
91792192|NCT01933789|183462212|SUPERIORITY||Probit regression coefficient|-0.034||||0.734|TWO_SIDED|95.0|-0.232|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.232|0.734
91482951|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
91630525|NCT01791465|183153215|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
91630526|NCT01791465|183153216|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91630527|NCT01791465|183153217|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91630528|NCT01791465|183153218|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
91630529|NCT01791465|183153219|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
91630530|NCT01791465|183153220|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91630531|NCT01791465|183153221|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91630532|NCT01791465|183153222|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
91630533|NCT02736929|183153230|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.12|TWO_SIDED|95.0|-2.7|22.3|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up||22.3|-2.7|0.12
91630534|NCT02736929|183153231|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.5|0.1|0.024
91630535|NCT02736929|183153232|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.027|TWO_SIDED|95.0|0.0|0.6|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.6|0.0|0.027
91630536|NCT02736929|183153233|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.024|TWO_SIDED|95.0|0.5|7.1|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||7.1|0.5|0.024
91630537|NCT02736929|183153234|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.19|TWO_SIDED|95.0|-9.8|2.0|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||2.0|-9.8|0.19
91630538|NCT02736929|183153235|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.31|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.4|-1.3|0.31
91630539|NCT02736929|183153236|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.5|-1.8|0.86
91714271|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|37.3||||||95.0|0.1|157.7|||ED-50: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.|Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||157.7|0.1|
91482952|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.1|-1.08|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.10|<0.001
91482953|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.61|-1.59||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.59|-2.61|<0.001
91482954|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.51|-1.49||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.49|-2.51|<0.001
91482955|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.83|-0.76||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.76|-1.83|<0.001
91482956|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.26|<0.001
91482957|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.53|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.46|-2.53|<0.001
91482958|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.00|-2.11|<0.001
91792193|NCT01933789|183462213|SUPERIORITY||Tobit regression coefficient|0.041||||0.935|TWO_SIDED|95.0|-0.946|1.028||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Clustered Tobit regression because strong floor effect on composite score. Adjusted for baseline level of composite score.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Standard GAD-7 composite score||1.028|-0.946|0.935
91482959|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.49|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.37|-2.49|<0.001
91482960|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.83|-1.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.72|-2.83|<0.001
91482961|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.87|-0.75||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.75|-1.87|<0.001
91482962|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.14|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.02|-2.14|<0.001
91482963|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
91482964|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.86|-0.74||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.74|-1.86|<0.001
91482965|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.17|-1.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.05|-2.17|<0.001
91630540|NCT02736929|183153237|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.77|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.2|-1.7|0.77
91482966|NCT00744471|182839273|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.91|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
91482967|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
91482968|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
91525597|NCT02002884|182926408|SUPERIORITY||LS-Mean difference|0.09|||=|0.34|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||LS-Means are from analysis of covariance (ANCOVA) with treatment group, pooled site and pretreatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.28|-0.1|= 0.34
91482969|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
91482970|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
91482971|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.88|<0.001
91482972|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.36|-0.73|<0.001
91482973|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.39|0.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||0.00|-0.39|0.054
91482974|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.29||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.29|-0.68|<0.001
91482975|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
91482976|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.15|-0.55|<0.001
91482977|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.81|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-0.81|<0.001
91482978|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.73|<0.001
91482979|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.45|-0.07||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.07|-0.45|0.008
91482980|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
91482981|NCT00744471|182839274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.43|-0.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.05|-0.43|0.012
91482982|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
91482983|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
91482984|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
91482985|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
91482986|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.87|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.87|<0.001
91482987|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
91630541|NCT02972593|183153241|OTHER|Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0.||||||0.0122|||||||Fisher Exact|||||||.0122
91630542|NCT02972593|183153242|OTHER|||||||0.7742|||||||Fisher Exact|||||||.7742
91630543|NCT02972593|183153243|OTHER|||||||0.1443|||||||t-test, 1 sided|||||||.1443
91630544|NCT00118404|183153253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.079|STANDARD_ERROR_OF_MEAN|0.39||0.42|TWO_SIDED|95.0|0.5|2.34|||Log Rank|log-rank chi-square = 0.038, df = 1, p \<=.42|Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.|The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.||2.34|0.50|.42
91630545|NCT00118404|183153253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481|STANDARD_ERROR_OF_MEAN|0.38||0.02|TWO_SIDED|95.0|0.23|1.01|||Log Rank|log-rank chi-square = 3.92, df = 1|Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.|||1.01|.23|.02
91630546|NCT00118404|183153253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519|STANDARD_ERROR_OF_MEAN|0.36||0.03|TWO_SIDED|95.0|0.26|1.06|||Log Rank|log-rank chi-square = 3.391, df = 1|Hazard ratio for relapse in C-CT group compared to that in the placebo group.|||1.06|0.26|.03
91665714|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.172||||0.678|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 6-weeks following quit date||||0.678
91665715|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|7.99||||0.018|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant interaction between baseline price sensitivity (latent factor Persistence) and treatment condition for 6-week abstinence outcome||||0.018
91665716|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.177||||0.674|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 12-weeks following quit date||||0.674
91792194|NCT01933789|183462214|SUPERIORITY||Probit regression coefficient|-0.042||||0.689|TWO_SIDED|95.0|-0.247|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.247|0.689
91482988|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.43|-0.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.03|-0.43|0.022
91525598|NCT02002884|182926408|SUPERIORITY||LS-Mean difference|-0.12|||=|0.297|TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||LS-Means are from ANCOVA with treatment group, pooled site and pre-treatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.11|-0.36|= 0.297
91630547|NCT00118404|183153253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501|STANDARD_ERROR_OF_MEAN|0.31||0.01|TWO_SIDED|95.0|0.27|0.93|||Log Rank|log-rank chi-square = 5.06, df = 1|Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.|||0.93|0.27|.01
91630548|NCT00118404|183153254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED|95.0|0.55|1.76|||Log Rank|log-rank chi-square = 0.002, df = 1|Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.|||1.76|0.55|.48
91630549|NCT00118404|183153254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.31||0.14|TWO_SIDED|95.0|0.39|1.31|||Log Rank|Chi-square = 1.19, df = 1|Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.31|.39|.14
91630550|NCT00118404|183153254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715|STANDARD_ERROR_OF_MEAN|0.3||0.13|TWO_SIDED|95.0|0.4|1.29|||Log Rank|chi-square = 1.262, df = 1|Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.29|.40|.13
91630551|NCT00118404|183153254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.26||0.1|TWO_SIDED|95.0|0.43|1.2|||Log Rank|Chi-square = 1.595, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.|||1.20|.43|.10
91630552|NCT00118404|183153255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075|STANDARD_ERROR_OF_MEAN|0.27||0.4|TWO_SIDED|95.0|0.63|1.84|||Log Rank|chi-square = .07, df = 1|Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.|||1.84|.63|.40
91630553|NCT00118404|183153255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649|STANDARD_ERROR_OF_MEAN|0.28||0.61|TWO_SIDED|95.0|0.37|1.13|||Log Rank|chi-square = 2.407, df = 1|Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.|||1.13|.37|.61
91630554|NCT00118404|183153255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.701|STANDARD_ERROR_OF_MEAN|0.27||0.09|TWO_SIDED|95.0|0.41|1.19|||Log Rank|chi-square = 1.731, df = 1|Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.|||1.19|.41|.09
91665717|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.646||||0.422|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 24-weeks following quit date||||0.422
91630555|NCT00118404|183153255|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.676|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|0.42|1.08|||Log Rank|chi-square = 2.705, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.|||1.08|.42|.05
91630556|NCT02407236|183153283|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|95.0|5.7|14.9|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||14.9|5.7|< 0.001
91630557|NCT02407236|183153283|SUPERIORITY||Adjusted treatment difference|10.2|||<|0.001|TWO_SIDED|95.0|5.6|14.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||14.8|5.6|< 0.001
91630558|NCT02407236|183153284|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|97.5|4.8|15.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||15.8|4.8|< 0.001
91630559|NCT02407236|183153284|SUPERIORITY||Adjusted treatment difference|12.7|||<|0.001|TWO_SIDED|97.5|7.0|18.4|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||18.4|7.0|< 0.001
91714272|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|123.9||||||95.0|0.4|523.9|||ED 90: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.|Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||523.9|0.4|
91482989|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.67|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.67|<0.001
91482990|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
91482991|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.19|-0.60|<0.001
91482992|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.47||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.47|-0.88|<0.001
91482993|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.79|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.79|<0.001
91482994|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.14||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.14|-0.53|<0.001
91482995|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.28|-0.68|<0.001
91482996|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.71|<0.001
91482997|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.01|TWO_SIDED|95.0|-0.47|-0.06||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.06|-0.47|0.010
91482998|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.25|-0.66|<0.001
91482999|NCT00744471|182839275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.53|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.13|-0.53|0.001
91483000|NCT04706416|182839298|SUPERIORITY||Odds Ratio (OR)|0.6||||0.297|TWO_SIDED|95.0|0.26|1.48|||Fisher Exact|||||1.48|0.26|0.297
91483001|NCT04706416|182839298|SUPERIORITY||Odds Ratio (OR)|0.68||||0.541|TWO_SIDED|95.0|0.19|2.3|||Regression, Logistic|||||2.30|0.19|0.541
91483002|NCT04706416|182839299|SUPERIORITY||Odds Ratio (OR)|0.37||||0.039|TWO_SIDED|95.0|0.15|0.91|||Fisher Exact|||||0.91|0.15|0.039
91483003|NCT04706416|182839299|SUPERIORITY||Odds Ratio (OR)|0.34||||0.081|TWO_SIDED|95.0|0.09|1.07|||Regression, Logistic|||||1.07|0.09|0.081
91483004|NCT04706416|182839300|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.643|TWO_SIDED|95.0|-1.0|3.0|||Wilcoxon (Mann-Whitney)|||||3.0|-1.0|0.643
91483005|NCT04706416|182839300|SUPERIORITY||β-coefficient|-4.27||||0.001|TWO_SIDED|95.0|-5.67|-2.87|||Regression, Linear|||||-2.87|-5.67|0.001
91483006|NCT04706416|182839301|SUPERIORITY||Odds Ratio (OR)|0.53||||0.133|TWO_SIDED|95.0|0.25|1.19|||Fisher Exact|||||1.19|0.25|0.133
91665718|NCT05740098|183225166|SUPERIORITY||Wald Chi-Square Test Statistic|0.038||||0.846|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 48-weeks following quit date||||0.846
91665719|NCT02452463|183225171|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
91665720|NCT02452463|183225173|SUPERIORITY|||||||0.75|||||||Log Rank|||Null Hypotheses: OS distributions are equal||||0.75
91665721|NCT02452463|183225174|SUPERIORITY|||||||0.25|||||||Log Rank|||Null Hypotheses: PFS distributions are equal||||0.25
91665722|NCT02452463|183225175|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||||||0.131
91665723|NCT02452463|183225176|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||||||0.073
91665724|NCT02452463|183225177|SUPERIORITY|||||||0.616|||||||t-test, 2 sided|||||||0.616
91665725|NCT02452463|183225177|SUPERIORITY|||||||0.183|||||||Paired T-test|||Comparing change relative to baseline.||||0.183
91665726|NCT02452463|183225177|SUPERIORITY|||||||0.203|||||||paired T-test|||Evaluating change relative to baseline.||||0.203
91792195|NCT01933789|183462215|SUPERIORITY||Tobit regression coefficient|-0.105||||0.852|TWO_SIDED|95.0|-1.204|0.995||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians. Clustered Tobit regression because of strong floor effect on composite score."|Clustered Tobit regression|Adjusted for baseline level of the GAD-7 composite score.|Control group coded 0; intervention group coded 1.|||0.995|-1.204|0.852
91483007|NCT04706416|182839302|SUPERIORITY||Hodges-Lehmann estimator|4.0||||0.092|TWO_SIDED|95.0|-1.0|12.0|||Wilcoxon (Mann-Whitney)|||||12.0|-1.0|0.092
91665727|NCT02452463|183225178|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.00
91665728|NCT01073631|183225180|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|78.9|||||TWO_SIDED|95.0|75.07|82.73|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||82.73|75.07|
91665729|NCT01131260|183225188|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.2|TWO_SIDED|95.0|0.87|1.98|||Chi-squared|||Analysis on primary composite outcome as a whole.||1.98|0.87|0.20
91483008|NCT04706416|182839303|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.834|TWO_SIDED|95.0|-2.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|-2.0|0.834
91483009|NCT04706416|182839304|SUPERIORITY||Odds Ratio (OR)|0.001||||0.149|TWO_SIDED|95.0|0.0|1.52|||Fisher Exact|||||1.52|0|0.149
91483010|NCT04706416|182839305|SUPERIORITY||Odds Ratio (OR)|0.3||||0.015|TWO_SIDED|95.0|0.12|0.8|||Fisher Exact|||||0.80|0.12|0.015
91483011|NCT01484054|182839334|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-3.2|5.2|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.||5.20|-3.20|
91483012|NCT01484054|182839335|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|4.7|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-0.79|10.19|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.||10.19|-0.79|
91483013|NCT01484054|182839336|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|9.44|STANDARD_ERROR_OF_MEAN|1.829|||TWO_SIDED|95.0|5.81|13.07|||Mixed Models Analysis|||Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.||13.07|5.81|
91665730|NCT01131260|183225190|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.02||||0.37|TWO_SIDED|95.0|0.31|29.1|||Fisher Exact|||||29.1|0.31|0.37
91665731|NCT01131260|183225191|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.86||||0.02|TWO_SIDED|95.0|1.13|7.24|||Chi-squared|||||7.24|1.13|0.02
91665732|NCT01131260|183225192|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||1|TWO_SIDED|95.0|0.17|3.38|||Fisher Exact|||||3.38|0.17|1.0
91665733|NCT01131260|183225193|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.13|TWO_SIDED|95.0|0.1|1.41|||Chi-squared|||||1.41|0.10|0.13
91665734|NCT01131260|183225194|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.57||||0.07|TWO_SIDED|95.0|0.97|2.54|||Chi-squared|||||2.54|0.97|0.07
91665735|NCT01131260|183225195|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||1|TWO_SIDED|95.0|0.22|3.0|||Fisher Exact|||||3.00|0.22|1.0
91665736|NCT01131260|183225196|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||.17
91665737|NCT01131260|183225197|SUPERIORITY_OR_OTHER|||||||0.45||||||The p value was calculated based on the entire study cohort.|Chi-squared|||||||0.45
91665738|NCT01131260|183225199|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||.32
91665739|NCT01131260|183225200|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
91665740|NCT01131260|183225201|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||||||0.40
91665741|NCT01131260|183225202|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
91665742|NCT01131260|183225203|SUPERIORITY_OR_OTHER|||||||0.19|||||||Chi-squared|||||||.19
91665743|NCT01131260|183225204|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91665744|NCT01131260|183225205|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
91665745|NCT01131260|183225206|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91665746|NCT01131260|183225207|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
91665747|NCT01131260|183225208|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||.05
91665748|NCT03544216|183225209|OTHER||||||<|0.001||||||"Results of post-hoc analyses comparing scores of each lens type to one another:~Habitual lens and multifocal contact lens: p \<0.001 Habitual lens and single vision lens: p \<0.001 Multifocal lens and single vision lens: p = 0.08"|Generalized linear models|||Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)||||<0.001
91665749|NCT03544216|183225209|OTHER|||||||0.5||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)||||0.5
91525599|NCT01616771|182926450|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
91525600|NCT01616771|182926451|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
91525601|NCT02247804|182926475|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295|TWO_SIDED|95.0|-1.17|0.36|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.36|-1.17|0.2950
91525602|NCT02247804|182926475|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.43|-1.09|0.3904
91525603|NCT02247804|182926475|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464|TWO_SIDED|95.0|-1.4|-0.01|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.01|-1.40|0.0464
91525604|NCT02247804|182926475|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383|TWO_SIDED|95.0|-0.9|0.47|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.47|-0.90|0.5383
91630560|NCT02407236|183153285|SUPERIORITY||Adjusted treatment difference|14.5||||0.002|TWO_SIDED|95.0|5.5|23.6|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||23.6|5.5|0.002
91630561|NCT02407236|183153285|SUPERIORITY||Adjusted treatment difference|19.7|||<|0.001|TWO_SIDED|95.0|10.3|29.0|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||29.0|10.3|< 0.001
91630562|NCT02407236|183153286|SUPERIORITY||Adjusted treatment difference|15.1||||0.002|TWO_SIDED|95.0|6.0|24.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||24.2|6.0|0.002
91630563|NCT02407236|183153286|SUPERIORITY||Adjusted treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|8.6|27.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||27.2|8.6|< 0.001
91630564|NCT01994109|183153364|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91630565|NCT01994109|183153364|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91665750|NCT03544216|183225209|OTHER|||||||0.7||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)||||0.7
91792196|NCT01933789|183462216|SUPERIORITY||probit regression coefficient|-0.221||||0.418|TWO_SIDED|95.0|-0.923|0.482||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient race and health status and by clinician type and specialty|Control group coded 0; intervention group coded 1.|||0.482|-0.923|0.418
91630566|NCT01994109|183153365|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91630567|NCT01994109|183153365|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91630568|NCT02418585|183153394|SUPERIORITY||Difference of Least Square (LS) Means|-4.0|STANDARD_ERROR_OF_MEAN|1.69|=|0.02|TWO_SIDED|95.0|-7.31|-0.64|||Mixed Model for Repeated Measures|||||-0.64|-7.31|=0.020
91630569|NCT02418585|183153395|SUPERIORITY||Difference of Least Square (LS) Means|-3.5|||=|0.034|TWO_SIDED|95.0|-6.67|-0.26|||ANCOVA|||||-0.26|-6.67|=0.034
91630570|NCT01236768|183153454|EQUIVALENCE|Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.||||||0.089|||||||Chi-squared|||Comparative evaluation of AG200-15 and Levora||||0.089
91665751|NCT03544216|183225209|OTHER|||||||0.3||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)||||0.3
91630571|NCT03949621|183153458|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9632|||||TWO_SIDED|90.0|0.7938|1.1688||||||||1.1688|0.7938|
91630572|NCT03949621|183153459|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9606|||||TWO_SIDED|90.0|0.798|1.1562||||||||1.1562|0.798|
91630573|NCT03949621|183153460|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0162|||||TWO_SIDED|90.0|0.9001|1.1473||||||||1.1473|0.9001|
91630574|NCT00605358|183153462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.018|TWO_SIDED|95.0|1.17|4.93|||Chi-squared|||Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.||4.93|1.17|.018
91630575|NCT01957085|183153464|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.04||||||Statistical significance was set at .05 to determine statistical significance.|Chi-squared|||||||=.04
91630576|NCT01957085|183153465|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
91792197|NCT01933789|183462217|SUPERIORITY||probit regression coefficient|0.175||||0.568|TWO_SIDED|95.0|-0.613|0.962||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.962|-0.613|0.568
91483014|NCT03737851|182839360|OTHER|a statistical test was not performed|Odds Ratio (OR)|1.202|||||TWO_SIDED|95.0|0.559|2.584||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||2.584|0.559|
91483015|NCT03737851|182839360|OTHER|a statistical test was not performed|Odds Ratio (OR)|0.615|||||TWO_SIDED|95.0|0.266|1.421||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||1.421|0.266|
91483016|NCT03496571|182839371|SUPERIORITY||LSM Difference from Placebo|-95.0|||<|0.001|TWO_SIDED|95.0|-122.0|-68.0|||ANCOVA|||||-68|-122|<0.001
91483017|NCT03496571|182839371|SUPERIORITY||LSM Difference from Placebo|-102.0|||<|0.001|TWO_SIDED|95.0|-128.0|-76.0|||ANCOVA|||||-76|-128|<0.001
91483018|NCT03496571|182839371|SUPERIORITY||LSM Difference from Placebo|-98.0|||<|0.001|TWO_SIDED|95.0|-121.0|-76.0|||ANCOVA|||||-76|-121|<0.001
91630577|NCT01957085|183153466|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
91630578|NCT01957085|183153468|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
91630579|NCT02148952|183153472|SUPERIORITY|We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.|Risk Ratio (RR)|0.99||||0.9|TWO_SIDED|95.0|0.83|1.18|||Chi-squared, Corrected|In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.|Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.18|0.83|0.90
91630580|NCT02148952|183153473|SUPERIORITY||Risk Ratio (RR)|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.20|0.89|0.67
91630581|NCT02148952|183153474|SUPERIORITY||Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected|||||1.20|0.89|0.68
91630582|NCT02148952|183153475|SUPERIORITY||Risk Ratio (RR)|0.94||||0.56|TWO_SIDED|95.0|0.76|1.16|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.16|0.76|0.56
91630583|NCT02148952|183153476|SUPERIORITY||Risk Ratio (RR)|1.1||||0.19|TWO_SIDED|95.0|0.95|1.27|||Chi-squared, Corrected|||||1.27|0.95|0.19
91630584|NCT02148952|183153477|SUPERIORITY||Risk Ratio (RR)|1.11||||0.73|TWO_SIDED|95.0|0.74|1.53|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.53|0.74|0.73
91483019|NCT03496571|182839372|SUPERIORITY||Percent Difference from Placebo|55.0|||<|0.001|TWO_SIDED|95.0|27.0|76.0|||Fisher Exact|||||76|27|<0.001
91483020|NCT03496571|182839372|SUPERIORITY||Percent Difference from Placebo|62.0|||<|0.001|TWO_SIDED|95.0|34.0|82.0|||Fisher Exact|||||82|34|<0.001
91483021|NCT03496571|182839372|SUPERIORITY||Percent Difference from Placebo|58.0|||<|0.001|TWO_SIDED|95.0|36.0|74.0|||Fisher Exact|||||74|36|<0.001
91483022|NCT03496571|182839373|SUPERIORITY||LSM Difference from Placebo|-20.0||||0.05|TWO_SIDED|95.0|-40.0|0.0|||ANCOVA|||||0|-40|0.05
91483023|NCT03496571|182839373|SUPERIORITY||LSM Difference from Placebo|-33.0||||0.002|TWO_SIDED|95.0|-53.0|-13.0|||ANCOVA|||||-13|-53|0.002
91483024|NCT03496571|182839373|SUPERIORITY||LSM Difference from Placebo|-26.0||||0.004|TWO_SIDED|95.0|-44.0|-9.0|||ANCOVA|||||-9|-44|0.004
91483025|NCT03119701|182839376|SUPERIORITY||Odds Ratio (OR)|1.3||||0.78|TWO_SIDED|95.0|0.21|8.19||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||8.19|0.21|0.78
91483026|NCT03119701|182839377|SUPERIORITY||Odds Ratio (OR)|1.7||||0.57|TWO_SIDED|95.0|0.28|10.52||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||10.52|0.28|0.57
91630585|NCT02148952|183153478|SUPERIORITY||Risk Ratio (RR)|0.97||||0.81|TWO_SIDED|95.0|0.79|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate any severe maternal complication within 7 days||1.20|0.79|0.81
91792198|NCT01933789|183462218|SUPERIORITY||probit regression coefficient|0.14||||0.592|TWO_SIDED|95.0|-0.534|0.815||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.815|-0.534|0.592
91483027|NCT03119701|182839378|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
91483028|NCT03119701|182839380|SUPERIORITY||||||>|0.999||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||>0.999
91630586|NCT02148952|183153478|SUPERIORITY||Risk Ratio (RR)|0.89||||0.76|TWO_SIDED|95.0|0.57|1.52|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of seizures||1.52|0.57|0.76
91483029|NCT03119701|182839383|SUPERIORITY|||||||0.362||||||The threshold for statistical significance was p = 0.05.|Mantel Haenszel|Exact Mantel-Haenszel Chi-Square Test||||||0.3620
91483030|NCT03119701|182839386|SUPERIORITY||||||<|0.0001||||||Day 2, Day 3, Day 4, Day 5, and Day 6.|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||<.0001
91483031|NCT03119701|182839386|SUPERIORITY|||||||0.13||||||Baseline visit|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.13
91483032|NCT03119701|182839386|SUPERIORITY|||||||0.0035||||||Day 1|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.0035
91483033|NCT03119701|182839386|SUPERIORITY|||||||0.009||||||Day 9|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.009
91483034|NCT03119701|182839386|SUPERIORITY|||||||0.1||||||Day 13|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.10
91483035|NCT03119701|182839387|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Patients with an observation below the lower limit of quantification (LLOQ) value at baseline for CD73 were set to have the LLOQ value (LLOQ = 4 ng/ml) at baseline for subgroup determination purposes (2-fold increase in CD73 from baseline). Values below the LLOQ were set to LLOQ/2 = 2 ng/mL.||||0.66
91483036|NCT03119701|182839388|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Observations of zero were imputed as 1 pg/ml before logarithmic transformation.||||0.3
91483037|NCT02247531|182839432|SUPERIORITY||Difference in Adjusted Means|0.157||||0.0479|TWO_SIDED|95.0|0.001|0.313|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.313|0.001|0.0479
91483038|NCT02247531|182839432|SUPERIORITY||Difference in Adjusted Means|0.087||||0.2739|TWO_SIDED|95.0|-0.069|0.243|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.243|-0.069|0.2739
91483039|NCT02247531|182839433|SUPERIORITY||Difference in Adjusted Means|-0.4||||0.84|TWO_SIDED|95.0|-4.8|3.9|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||3.9|-4.8|0.8400
91483040|NCT02247531|182839433|SUPERIORITY||Difference in Adjusted Means|1.3||||0.5587|TWO_SIDED|95.0|-3.1|5.7|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.7|-3.1|0.5587
91483041|NCT02247531|182839434|SUPERIORITY||Difference in Adjusted Means|0.1||||0.8358|TWO_SIDED|95.0|-0.88|1.09|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.09|-0.88|0.8358
91483042|NCT02247531|182839434|SUPERIORITY||Difference in Adjusted Means|-0.26||||0.6117|TWO_SIDED|95.0|-1.25|0.74|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.74|-1.25|0.6117
91483043|NCT02247531|182839435|SUPERIORITY||Difference in Adjusted Means|0.7||||0.4651|TWO_SIDED|95.0|-1.2|2.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.5|-1.2|0.4651
91483044|NCT02247531|182839435|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7885|TWO_SIDED|95.0|-1.6|2.1|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.1|-1.6|0.7885
91483045|NCT02247531|182839436|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6892|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||||1.8|0.7|0.6892
91483046|NCT02247531|182839436|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9104|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9104
91483047|NCT02247531|182839437|SUPERIORITY||Difference in Adjusted Means|-0.1||||0.8931|TWO_SIDED|95.0|-1.8|1.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.5|-1.8|0.8931
91483048|NCT02247531|182839437|SUPERIORITY||Difference in Adjusted Means|-1.1||||0.1754|TWO_SIDED|95.0|-2.8|0.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||0.5|-2.8|0.1754
91483049|NCT02247531|182839438|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3707|TWO_SIDED|95.0|0.7|2.2|||Regression, Logistic|||||2.2|0.7|0.3707
91483050|NCT02247531|182839438|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8382|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.8382
91483051|NCT02247531|182839439|SUPERIORITY||Difference in Adjusted Means|1.35||||0.6841|TWO_SIDED|95.0|-5.16|7.85|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.85|-5.16|0.6841
91483052|NCT02247531|182839439|SUPERIORITY||Difference in Adjusted Means|1.07||||0.7443|TWO_SIDED|95.0|-5.37|7.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.52|-5.37|0.7443
91483053|NCT02247531|182839440|SUPERIORITY||Difference in Adjusted Means|0.12||||0.9713|TWO_SIDED|95.0|-6.28|6.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||6.52|-6.28|0.9713
91483054|NCT02247531|182839440|SUPERIORITY||Difference in Adjusted Means|-1.72||||0.5945|TWO_SIDED|95.0|-8.08|4.63|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||4.63|-8.08|0.5945
91483055|NCT02247531|182839441|SUPERIORITY||Difference in Adjusted Means|1.22||||0.2438|TWO_SIDED|95.0|-0.83|3.27|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.27|-0.83|0.2438
91483056|NCT02247531|182839441|SUPERIORITY||Difference in Adjusted Means|1.03||||0.3202|TWO_SIDED|95.0|-1.01|3.07|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.07|-1.01|0.3202
91792199|NCT01933789|183462221|SUPERIORITY||probit regression coefficient|-0.179||||0.705|TWO_SIDED|95.0|-1.398|1.04||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||1.040|-1.398|0.705
91483057|NCT02247531|182839442|SUPERIORITY||Difference in Adjusted Means|2.64||||0.0388|TWO_SIDED|95.0|0.14|5.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||5.14|0.14|0.0388
91483058|NCT02247531|182839442|SUPERIORITY||Difference in Adjusted Means|2.2||||0.0833|TWO_SIDED|95.0|-0.29|4.68|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||4.68|-0.29|0.0833
91483059|NCT02247531|182839443|SUPERIORITY||Difference in Adjusted Means|1.04||||0.4795|TWO_SIDED|95.0|-1.84|3.91|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.91|-1.84|0.4795
91483060|NCT02247531|182839443|SUPERIORITY||Difference in Adjusted Means|0.6||||0.6822|TWO_SIDED|95.0|-2.26|3.45|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.45|-2.26|0.6822
91483061|NCT02247531|182839444|SUPERIORITY||Difference in Adjusted Means|0.04||||0.5227|TWO_SIDED|95.0|-0.07|0.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.14|-0.07|0.5227
91483062|NCT02247531|182839444|SUPERIORITY||Difference in Adjusted Means|0.02||||0.7475|TWO_SIDED|95.0|-0.09|0.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.13|-0.09|0.7475
91483063|NCT02247531|182839445|SUPERIORITY||Difference in Adjusted Means|0.049||||0.6333|TWO_SIDED|95.0|-0.153|0.252|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.252|-0.153|0.6333
91483064|NCT02247531|182839445|SUPERIORITY||Difference in Adjusted Means|0.025||||0.8105|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.230|-0.180|0.8105
91483065|NCT02247531|182839445|SUPERIORITY||Difference in Adjusted Means|0.34||||0.0063|TWO_SIDED|95.0|0.097|0.584|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.584|0.097|0.0063
91483066|NCT02247531|182839445|SUPERIORITY||Difference in Adjusted Means|0.182||||0.1359|TWO_SIDED|95.0|-0.058|0.422|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.422|-0.058|0.1359
91483067|NCT03646643|182839474|SUPERIORITY||Hazard Ratio (HR)|0.12||||0.047|TWO_SIDED|95.0|0.02|0.97||A priori threshold \<0.05. Multiple comparisons adjustments: not needed.|Log Rank||The distal CS to LA connection elimination group had fewer recurrences (6.7%) compared with the standard group (46.7%), which translated to an 88% lower hazard of recurrence compared with the standard group.|Power calculation: assuming alpha 0.05, power 0.8, 1:1 randomization, and estimated relative risk of 14.4 for AF susceptibility with rate-dependent CS-LA conduction block, we anticipated a minimum sample size of 6 patients per group would be necessary to detect a difference using the log-rank test. Additional patients were recruited to account for potential losses to follow-up and a smaller detectable difference.||0.97|0.02|0.047
91483068|NCT03170232|182839509|OTHER||Mean Difference (Final Values)|-67.2|STANDARD_ERROR_OF_MEAN|159.7||0.679|TWO_SIDED|95.0|-400.6|266.2|||Repeated measures random coefficient|||||266.2|-400.6|0.679
91483069|NCT02537574|182839529|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.264||0.94|TWO_SIDED|95.0|0.61|1.7|||Regression, Logistic|||||1.70|0.61|0.940
91483070|NCT02537574|182839529|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.207||0.383|TWO_SIDED|95.0|0.48|1.33|||Regression, Logistic|||||1.33|0.48|0.383
91483071|NCT01593722|182839537|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.68
91483072|NCT05014490|182839614|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|102.15|||||TWO_SIDED|90.0|94.54|110.37|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||110.37|94.54|
91483073|NCT05014490|182839615|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|99.23|||||TWO_SIDED|90.0|96.97|101.54|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||101.54|96.97|
91630587|NCT02148952|183153478|SUPERIORITY||Risk Ratio (RR)|0.98||||0.97|TWO_SIDED|95.0|0.7|1.41|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of loss of consciousness for \> 1 hr||1.41|0.70|0.97
91483074|NCT02017171|182839627|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.999|TWO_SIDED|95.0|-1.9|1.9||p value is not adjusted for multiple comparisons, a priori threshold for statistical significance: p\<0.05|linear model for correlated errors||Treatment difference = Allopurinol-Placebo|||1.9|-1.9|0.999
91483075|NCT02017171|182839628|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.6|2.2||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.2|-1.6|
91483076|NCT02017171|182839629|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.3|-1.7|
91483077|NCT02017171|182839630|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.5|0.4||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.4|-1.5|
91483078|NCT02017171|182839631|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.0|0.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.5|-1.0|
91483079|NCT02017171|182839632|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.5|2.9||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||2.9|0.5|
91692015|NCT01139775|183278478|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.96|||||TWO_SIDED||||||||Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.|The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.||||
91483080|NCT02017171|182839633|SUPERIORITY||Ratio (Final Values)|1.4|||||TWO_SIDED|95.0|1.0|1.8||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||1.8|1.0|
91483081|NCT02017171|182839634|SUPERIORITY||Ratio (Final Values)|1.3|||||TWO_SIDED|95.0|1.0|1.6||For secondary outcomes, 95% confidence intervals are reported, without P values.|||||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|1.6|1.0|
91483082|NCT02017171|182839635|SUPERIORITY||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|4.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||4.5|0.8|
91483083|NCT00945854|182839638|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
91483084|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.291|STANDARD_ERROR_OF_MEAN|0.2838|||TWO_SIDED|90.0|-0.195|0.777|||mixed model repeated measures|||Week 12||0.777|-0.195|
91483085|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.282|STANDARD_ERROR_OF_MEAN|0.2843|||TWO_SIDED|90.0|-0.206|0.769|||mixed model repeated measures|||Week 12||0.769|-0.206|
91483086|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.658|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|90.0|0.017|1.299|||mixed model repeated measures|||Week 24||1.299|0.017|
91483087|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.3791|||TWO_SIDED|90.0|0.189|1.49|||mixed model repeated measures|||Week 24||1.490|0.189|
91630588|NCT02148952|183153478|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9|TWO_SIDED|95.0|0.76|1.38|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of high fever with foul-smelling vaginal discharge||1.38|0.76|0.90
91692016|NCT01139775|183278480|SUPERIORITY_OR_OTHER|||||||0.2294|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Log Rank|||||||0.2294
91483088|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.668|STANDARD_ERROR_OF_MEAN|0.4954|||TWO_SIDED|90.0|-0.177|1.512|||mixed model repeated measures|||Week 36||1.512|-0.177|
91483089|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.912|STANDARD_ERROR_OF_MEAN|0.4887|||TWO_SIDED|90.0|0.078|1.746|||mixed model repeated measures|||Week 36||1.746|0.078|
91483090|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|0.976|STANDARD_ERROR_OF_MEAN|0.4813|||TWO_SIDED|90.0|0.15|1.803|||mixed model repeated measures|||Week 48||1.803|0.150|
91630589|NCT02148952|183153478|SUPERIORITY||Risk Ratio (RR)|0.95||||0.61|TWO_SIDED|95.0|0.77|1.17|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of hemorrhage||1.17|0.77|0.61
91630590|NCT02148952|183153478|SUPERIORITY||Risk Ratio (RR)|0.5||||0.41|TWO_SIDED|95.0|0.34|1.58|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of stroke||1.58|0.34|0.41
91630591|NCT02148952|183153479|SUPERIORITY||Risk Ratio (RR)|1.07||||0.74|TWO_SIDED|95.0|0.72|1.58|||Chi-squared, Corrected|||||1.58|0.72|0.74
91630592|NCT02148952|183153480|SUPERIORITY||Risk Ratio (RR)|1.09||||0.57|TWO_SIDED|95.0|0.81|1.47|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.47|0.81|0.57
91630593|NCT02148952|183153481|SUPERIORITY||Risk Ratio (RR)|1.19||||0.41|TWO_SIDED|95.0|0.78|1.8|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.80|0.78|0.41
91630594|NCT02148952|183153482|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.45|2.13|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||2.13|0.45|0.95
91630595|NCT02148952|183153483|SUPERIORITY||Risk Ratio (RR)|0.99||||0.97|TWO_SIDED|95.0|0.69|1.43|||Chi-squared, Corrected|||||1.43|0.69|0.97
91665752|NCT03544216|183225209|OTHER|||||||0.047||||||Analysis controlled for order, visit, and repeated measures|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to \<35 years old and 35 to 40 years old, by self report)|"Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type\*age group) produced the following results:~p = 0.01 for MF\*\<35 age group compared to Single Vision (SV)\*\<35 age group p = 0.07 for MF\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\<35 age group compared to Single Vision (SV)\*\>35 age group p \> 0.05 for SV\*\<35 age group compared to SV\*\>35 age group p \>0.05 for SV\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\>35 age group compared to SV\*\>25 age group"|||0.047
91483091|NCT04437368|182839682|SUPERIORITY||LS Mean Difference|1.233|STANDARD_ERROR_OF_MEAN|0.4573|||TWO_SIDED|90.0|0.445|2.022|||mixed model repeated measures|||Week 48||2.022|0.445|
91483092|NCT04437368|182839683|SUPERIORITY||LS Mean Difference|1.769|STANDARD_ERROR_OF_MEAN|1.2808|||TWO_SIDED|90.0|-0.441|3.979|||mixed model repeated measures|||Week 72||3.979|-0.441|
91630596|NCT02148952|183153484|SUPERIORITY||Risk Ratio (RR)|0.91||||0.32|TWO_SIDED|95.0|0.76|1.1|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.10|0.76|0.32
91630597|NCT02148952|183153485|SUPERIORITY||Risk Ratio (RR)|0.92||||0.3|TWO_SIDED|95.0|0.78|1.08|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.08|0.78|0.30
91630598|NCT02148952|183153486|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
91630599|NCT02148952|183153487|SUPERIORITY||Other|0.0||||0.18|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Birth Companion Present||||0.18
91630600|NCT02148952|183153487|SUPERIORITY||Risk Ratio (RR)|9.8|||<|0.001|TWO_SIDED|95.0|3.4|28.3|||Chi-squared, Corrected|||Maternal blood pressure taken||28.3|3.4|<0.001
91630601|NCT02148952|183153487|SUPERIORITY||Risk Ratio (RR)|132.0|||<|0.001|TWO_SIDED|95.0|26.9|645.0|||Chi-squared, Corrected|||Maternal temperature taken||645|26.9|<0.001
91630602|NCT02148952|183153487|SUPERIORITY||Risk Ratio (RR)|7.3||||0.01|TWO_SIDED|95.0|1.5|35.6|||Chi-squared, Corrected|||Partography started||35.6|1.5|0.01
91630603|NCT02148952|183153487|SUPERIORITY||Risk Ratio (RR)|413.0|||<|0.001|TWO_SIDED|95.0|65.8|2589.0|||Chi-squared, Corrected|||Checklist use||2589|65.8|<0.001
91630604|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|53.3|||<|0.001|TWO_SIDED|95.0|13.1|217.0|||Chi-squared, Corrected|||Hand hygiene||217|13.1|<0.001
91692017|NCT01139775|183278481|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0824
91483093|NCT04437368|182839683|SUPERIORITY||LS Mean Difference|1.274|STANDARD_ERROR_OF_MEAN|1.2349|||TWO_SIDED|90.0|-0.863|3.412|||mixed model repeated measures|||Week 72||3.412|-0.863|
91630605|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|2.3||||0.007|TWO_SIDED|95.0|1.3|4.2|||Chi-squared, Corrected|||No oxytocin given before delivery||4.2|1.3|0.007
91630606|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|5.7|||<|0.001|TWO_SIDED|95.0|2.7|12.1|||Chi-squared, Corrected|||Clean towel available||12.1|2.7|<0.001
91630607|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared, Corrected|||Clean scissors or blade available||1.7|0.7|0.72
91630608|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|1.0||||0.48|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.48
91630609|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|1.0||||0.73|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|0.9|0.73
91630610|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|1.0||||0.56|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Neonatal bag and mask available||1.1|0.9|0.56
91630611|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|2.1||||0.005|TWO_SIDED|95.0|1.3|3.5|||Chi-squared, Corrected|||Pads available||3.5|1.3|0.005
91630612|NCT02148952|183153488|SUPERIORITY||Risk Ratio (RR)|185.0|||<|0.001|TWO_SIDED|95.0|19.7|1738.0|||Chi-squared, Corrected|||Checklist use||1738|19.7|<0.001
91630613|NCT02148952|183153489|SUPERIORITY||Risk Ratio (RR)|3.9|||<|0.001|TWO_SIDED|95.0|2.1|7.2|||Chi-squared, Corrected|||Oxytocin administered||7.2|2.1|<0.001
91692018|NCT01139775|183278482|SUPERIORITY_OR_OTHER|||||||0.4924|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Wilcoxon (Mann-Whitney)|||||||0.4924
91483094|NCT04437368|182839683|SUPERIORITY||LS Mean Difference|2.041|STANDARD_ERROR_OF_MEAN|1.4177|||TWO_SIDED|90.0|-0.386|4.468|||mixed model repeated measures|||Week 96||4.468|-0.386|
91665753|NCT01935674|183225210|SUPERIORITY||Mean Difference (Net)|12.7||||0.003|TWO_SIDED|95.0|2.9|22.5||P-value from Wilcoxon rank-sum test; significance threshold set at α = 0.05. No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|Two-sided test; analysis based on intention-to-treat population.||Comparison of percentage change in fasting total cholesterol from baseline to week 12 between rosuvastatin and PI/r switch groups. Wilcoxon rank-sum test used. Study powered to detect a 15% difference with 80% power and α = 0.05. All participants included in intention-to-treat analysis.||22.5|2.9|0.003
91483095|NCT04437368|182839683|SUPERIORITY||LS Mean|1.278|STANDARD_ERROR_OF_MEAN|1.3857|||TWO_SIDED|90.0|-1.099|3.655|||mixed model repeated measures|||Week 96||3.655|-1.099|
91665754|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||4mg/day vs Placebo||||0.814
91483096|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|90.0|-10.3|8.1|||mixed model repeated measures|||Week 12||8.1|-10.3|
91483097|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-16.3|3.7|||mixed model repeated measures|||Week 12||3.7|-16.3|
91483098|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|90.0|-14.5|4.1|||mixed model repeated measures|||Week 24||4.1|-14.5|
91483099|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|-21.7|-1.6|||mixed model repeated measures|||Week 24||-1.6|-21.7|
91483100|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-18.4|0.5|||mixed model repeated measures|||Week 36||0.5|-18.4|
91483101|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|90.0|-22.1|-1.7|||mixed model repeated measures|||Week 36||-1.7|-22.1|
91483102|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|90.0|-12.7|6.9|||mixed model repeated measures|||Week 48||6.9|-12.7|
91483103|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|90.0|-17.9|2.7|||mixed model repeated measures|||Week 48||2.7|-17.9|
91483104|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-7.4|12.5|||mixed model repeated measures|||Week 72||12.5|-7.4|
91483105|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.18|||TWO_SIDED|90.0|-11.1|9.6|||mixed model repeated measures|||Week 72||9.6|-11.1|
91483106|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|90.0|-8.7|11.5|||mixed model repeated measures|||Week 96||11.5|-8.7|
91483107|NCT04437368|182839689|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-13.8|7.8|||mixed model repeated measures|||Week 96||7.8|-13.8|
91483108|NCT00495131|182839712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80||||< 0.001
91665755|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||8 mg/day vs Placebo||||0.013
91483109|NCT01539317|182839765|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Wilcoxon (Mann-Whitney)|||Phase II: During Blinded 4 weeks||||0.0149
91483110|NCT01539317|182839765|SUPERIORITY_OR_OTHER|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Phase III||||0.412
91483111|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Desire||||0.66
91483112|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Arousal (S)||||0.11
91483113|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Arousal (L)||||0.15
91483114|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Arousal (C)||||0.28
91483115|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Orgasm||||0.07
91483116|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Pain||||0.004
91483117|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Enjoyment||||0.54
91483118|NCT01539317|182839766|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Partner||||0.92
91483119|NCT01539317|182839767|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites|Wilcoxon (Mann-Whitney)|||||||<0.001
91483120|NCT00364130|182839796|SUPERIORITY_OR_OTHER|||||||0.38||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.38
91483121|NCT00364130|182839797|SUPERIORITY_OR_OTHER|||||||0.8||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.80
91483122|NCT00364130|182839798|SUPERIORITY_OR_OTHER|||||||0.02||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.02
91483123|NCT00364130|182839799|SUPERIORITY_OR_OTHER|||||||0.27||||||The outcome was not adjusted for multiple comparisons|Regression, Linear|||||||0.27
91483124|NCT00364130|182839800|SUPERIORITY_OR_OTHER|||||||0.84||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.84
91483125|NCT00364130|182839801|SUPERIORITY_OR_OTHER|||||||0.66||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.66
91483126|NCT00364130|182839802|SUPERIORITY_OR_OTHER|||||||0.7||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.70
91483127|NCT00364130|182839803|SUPERIORITY_OR_OTHER|||||||0.98||||||Outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.98
91483128|NCT04616027|182839804|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|99.67|||||TWO_SIDED|90.0|70.15|141.6||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||141.60|70.15|
91483129|NCT04616027|182839804|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.34|||||TWO_SIDED|90.0|70.51|145.63||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||145.63|70.51|
91483130|NCT04616027|182839804|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|146.56|||||TWO_SIDED|90.0|103.16|208.22||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||208.22|103.16|
91665756|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||12 mg/day vs Placebo||||0.287
91630614|NCT02148952|183153489|SUPERIORITY||Risk Ratio (RR)|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Chi-squared, Corrected|||Neonatal bag used||1.4|0.3|0.25
91630615|NCT02148952|183153489|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth attendant present||1.0|1.0|0.25
91630616|NCT02148952|183153490|SUPERIORITY||Risk Ratio (RR)|1.1||||0.25|TWO_SIDED|95.0|0.9|1.4|||Chi-squared, Corrected|||Newborn weight taken||1.4|0.9|0.25
91630617|NCT02148952|183153490|SUPERIORITY||Risk Ratio (RR)|317.0|||<|0.001|TWO_SIDED|95.0|50.4|1989.0|||Chi-squared, Corrected|||Newborn temperature taken||1989|50.4|<0.001
91630618|NCT02148952|183153490|SUPERIORITY||Risk Ratio (RR)|7.3|||<|0.001|TWO_SIDED|95.0|2.4|22.0|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||22.0|2.4|<0.001
91630619|NCT02148952|183153490|SUPERIORITY||Risk Ratio (RR)|38.7|||<|0.001|TWO_SIDED|95.0|7.7|194.0|||Chi-squared, Corrected|||Skin-to-skin care maintained for 1 hr||194|7.7|<0.001
91665757|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||16 mg/day vs Placebo||||0.027
91665758|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||24 mg/day vs Placebo||||0.390
91665759|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||4mg/day vs Placebo||||0.844
91483131|NCT04616027|182839804|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|71.31|143.92||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||143.92|71.31|
91483132|NCT04616027|182839805|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.71|||||TWO_SIDED|90.0|79.52|156.93||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||156.93|79.52|
91483133|NCT04616027|182839805|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.31|||||TWO_SIDED|90.0|83.49|173.38||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||173.38|83.49|
91483134|NCT04616027|182839805|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.18|||||TWO_SIDED|90.0|94.46|190.62||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||190.62|94.46|
91630620|NCT02148952|183153490|SUPERIORITY||Risk Ratio (RR)|19.4|||<|0.001|TWO_SIDED|95.0|11.4|33.2|||Chi-squared, Corrected|||Initiation of breast-feeding||33.2|11.4|<0.001
91630621|NCT02148952|183153490|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
91630622|NCT02148952|183153491|SUPERIORITY||Risk Ratio (RR)|182.0|||<|0.001|TWO_SIDED|95.0|33.5|993.0|||Chi-squared, Corrected|||Maternal temperature taken||993|33.5|<0.001
91630623|NCT02148952|183153491|SUPERIORITY||Risk Ratio (RR)|9.9|||<|0.001|TWO_SIDED|95.0|3.8|25.8|||Chi-squared, Corrected|||Maternal blood pressure taken||25.8|3.8|<0.001
91630624|NCT02148952|183153491|SUPERIORITY||Risk Ratio (RR)|0.4||||0.3|TWO_SIDED|95.0|0.1|2.1|||Chi-squared, Corrected|||Mother given magnesium sulfate||2.1|0.1|0.30
91630625|NCT02148952|183153492|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
91483135|NCT04616027|182839805|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|100.99|||||TWO_SIDED|90.0|71.89|141.87||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.87|71.89|
91483136|NCT04616027|182839806|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.02|||||TWO_SIDED|90.0|79.6|154.86||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||154.86|79.60|
91630626|NCT02148952|183153493|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|1.00
91483137|NCT04616027|182839806|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|116.7|||||TWO_SIDED|90.0|82.76|164.56||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||164.56|82.76|
91483138|NCT04616027|182839806|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.68|||||TWO_SIDED|90.0|96.56|187.85||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||187.85|96.56|
91630627|NCT02148952|183153493|SUPERIORITY||Risk Ratio (RR)|19.1|||<|0.001|TWO_SIDED|95.0|7.9|46.5|||Chi-squared, Corrected|||Maternal blood pressure taken||46.5|7.9|<0.001
91630628|NCT02148952|183153493|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated due to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
91630629|NCT02148952|183153493|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Partography started||||<0.001
91630630|NCT02148952|183153493|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
91630631|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|19.9|||<|0.001|TWO_SIDED|95.0|6.6|60.4|||Chi-squared, Corrected|||Hand hygiene||60.4|6.6|<0.001
91630632|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|2.1||||0.04|TWO_SIDED|95.0|1.0|4.1|||Chi-squared, Corrected|||No oxytocin given before delivery||4.1|1.0|0.04
91630633|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|2.4||||0.006|TWO_SIDED|95.0|1.3|4.3|||Chi-squared, Corrected|||Clean towel available||4.3|1.3|0.006
91630634|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|1.0||||0.34|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Clean scissors or blade available||1.1|1.0|0.34
91630635|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.25
91665760|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||8 mg/day vs Placebo||||0.030
91665761|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||12 mg/day vs Placebo||||0.437
91665762|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||16 mg/day vs Placebo||||0.034
91665763|NCT01494532|183225218|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||24 mg/day vs Placebo||||0.808
91630636|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|1.0|0.50
91483139|NCT04616027|182839806|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|72.63|141.3||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.30|72.63|
91483140|NCT04616027|182839807|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.52|||||TWO_SIDED|90.0|88.89|115.94||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||115.94|88.89|
91483141|NCT04616027|182839807|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|110.17|||||TWO_SIDED|90.0|96.05|126.37||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||126.37|96.05|
91483142|NCT04616027|182839807|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.63|||||TWO_SIDED|90.0|105.63|137.77||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||137.77|105.63|
91483143|NCT04616027|182839807|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|127.06|||||TWO_SIDED|90.0|111.26|145.12||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||145.12|111.26|
91483144|NCT04221230|182839888|OTHER||Least square mean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.08||0.121|TWO_SIDED|95.0|-3.8|0.4|||Mixed Model Repeated Measures|||||0.4|-3.8|0.121
91483145|NCT00191646|182839955|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Log Rank|||Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.||||0.199
91483146|NCT00191646|182839956|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||||||0.771
91483147|NCT00191646|182839956|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||Fisher Exact|||||||0.784
91483148|NCT00191646|182839957|SUPERIORITY_OR_OTHER|||||||0.621||95.0|||||Log Rank|||||||0.621
91483149|NCT00191646|182839958|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Log Rank|||||||0.013
91483150|NCT00252629|182839988|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0002
91483151|NCT00252629|182839989|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||t-test, 2 sided|||The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0008
91483152|NCT00252629|182839990|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.004
91483153|NCT00252629|182839991|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|||The p value was based on t-test||||0.0001
91483154|NCT00395538|182839998|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the year 1 biopsy.||||||0.015||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, 2 \& 4 combined as the dependent variable; biopsy year as the independent variable, covariate for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate was included because it would over-parameterize the model.||||0.015
91483155|NCT00395538|182839998|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate included because it would over-parameterize the model.||||0.002
91630637|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|1.0||||0.32|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Neonatal bag and mask available||1.0|1.0|0.32
91483156|NCT00395538|182839998|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.649||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Cn.BV/TV change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Cn.BV/TV, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.649
91483157|NCT00395538|182839999|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.N values for both their baseline and year 1 biopsies.||||||0.371||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.371
91630638|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|1.4||||0.11|TWO_SIDED|95.0|0.9|2.1|||Chi-squared, Corrected|||Pads available||2.1|0.9|0.11
91630639|NCT02148952|183153494|SUPERIORITY||Risk Ratio (RR)|37.9|||<|0.001|TWO_SIDED|95.0|7.3|196.0|||Chi-squared, Corrected|||Checklist available||196|7.3|<0.001
91630640|NCT02148952|183153495|SUPERIORITY||Risk Ratio (RR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.5|||Chi-squared, Corrected|||Oxytocin administered||7.5|1.8|<0.001
91630641|NCT02148952|183153495|SUPERIORITY||Risk Ratio (RR)|0.6||||0.19|TWO_SIDED|95.0|0.3|1.3|||Chi-squared, Corrected|||Neonatal bag used||1.3|0.3|0.19
91630642|NCT02148952|183153495|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|0.50
91630643|NCT02148952|183153496|SUPERIORITY||Risk Ratio (RR)|1.1||||0.08|TWO_SIDED|95.0|1.0|1.3|||Chi-squared, Corrected|||Newborn weight taken||1.3|1.0|0.08
91630644|NCT02148952|183153496|SUPERIORITY||Risk Ratio (RR)|91.5|||<|0.001|TWO_SIDED|95.0|11.0|758.0|||Chi-squared, Corrected|||Newborn temperature taken||758|11.0|<0.001
91483158|NCT00395538|182839999|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.129||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Po.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Po.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.129
91483159|NCT00395538|182839999|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.538||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.538
91483160|NCT00395538|182840000|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the year 1 biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|A baseline covariate not added to model since it would over-parameterize the model.||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
91483161|NCT00395538|182840000|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91630645|NCT02148952|183153496|SUPERIORITY||Risk Ratio (RR)|8.2|||<|0.001|TWO_SIDED|95.0|2.5|27.5|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||27.5|2.5|<0.001
91630646|NCT02148952|183153496|SUPERIORITY||Other|0.0||||0.01|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Skin-to-skin care maintained for 1 hr||||0.01
91630647|NCT02148952|183153496|SUPERIORITY||Risk Ratio (RR)|7.9|||<|0.001|TWO_SIDED|95.0|3.7|16.7|||Chi-squared, Corrected|||Initiation of breast-feeding||16.7|3.7|<0.001
91630648|NCT02148952|183153496|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
91630649|NCT02148952|183153497|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
91630650|NCT02148952|183153497|SUPERIORITY||Risk Ratio (RR)|12.7|||<|0.001|TWO_SIDED|95.0|4.7|34.3|||Chi-squared, Corrected|||Maternal blood pressure taken||34.3|4.7|<0.001
91630651|NCT02148952|183153497|SUPERIORITY||Risk Ratio (RR)|1.1||||0.95|TWO_SIDED|95.0|0.2|6.6|||Chi-squared, Corrected|||Mother given magnesium sulfate||6.6|0.2|0.95
91630652|NCT01899768|183153532|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.26|||||TWO_SIDED|90.0|1.1|1.44|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.44|1.10|
91630653|NCT01899768|183153533|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.02|||||TWO_SIDED|90.0|0.87|1.19|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.19|0.87|
91630654|NCT01899768|183153556|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.23|||||TWO_SIDED|90.0|0.86|1.75|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.75|0.86|
91630655|NCT01899768|183153556|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.36|||||TWO_SIDED|90.0|1.07|1.72|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 4-8 hr.|||1.72|1.07|
91630656|NCT01899768|183153557|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.97|||||TWO_SIDED|90.0|0.67|1.4|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.40|0.67|
91630657|NCT01899768|183153557|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means = GSK2|1.04|||||TWO_SIDED|90.0|0.79|1.36|||Ratio of adjusted geometric mean|||||1.36|0.79|
91525605|NCT02247804|182926476|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
91525606|NCT02247804|182926476|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
91525607|NCT02247804|182926477|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057||95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
91525608|NCT02247804|182926477|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031||95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
91525609|NCT02247804|182926478|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547||95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
91525610|NCT02247804|182926478|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107||95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
91525611|NCT02247804|182926479|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.086||95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
91525612|NCT02247804|182926479|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
91525613|NCT02247804|182926480|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295||95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.36|-1.17|0.2950
91792200|NCT01933789|183462222|SUPERIORITY||probit regression coefficient|0.123||||0.644|TWO_SIDED|95.0|-0.56|0.805||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.805|-0.560|0.644
91792201|NCT01933789|183462223|SUPERIORITY||probit regression coefficient|-0.165||||0.908|TWO_SIDED|95.0|-3.833|3.503||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient education and health status and by clinician gender.|Control group coded 0; intervention group coded 1.|||3.503|-3.833|0.908
91792202|NCT01933789|183462224|SUPERIORITY||probit regression coefficient|-0.121||||0.552|TWO_SIDED|95.0|-0.646|0.403||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.403|-0.646|0.552
91483162|NCT00395538|182840000|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.374||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.374
91483163|NCT00395538|182840001|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
91483164|NCT00395538|182840001|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91483165|NCT00395538|182840001|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.168||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.168
91483166|NCT00395538|182840002|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.BFR/BS values for both their baseline and year 1 biopsies.||||||0.083||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.083
91483167|NCT00395538|182840002|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483168|NCT00395538|182840002|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.164||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.164
91489388|NCT02484690|182851572|SUPERIORITY||Difference in Percentage of Participants|-6.64||||0.5586|TWO_SIDED|80.0|-18.6|5.32||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||5.32|-18.60|0.5586
91630658|NCT00414973|183153585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|2.89|5.89||There were no adjustments for multiple comparisons.|ANCOVA||Difference = Teriparatide minus Calcitonin|Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.||5.89|2.89|<0.0001
91630659|NCT00414973|183153586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.7||0.9062||95.0|-1.3|1.46|||ANCOVA||Difference = Teriparatide minus Calcitonin|||1.46|-1.30|0.9062
91630660|NCT00414973|183153587|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
91483169|NCT00395538|182840003|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MS/BS values for both their baseline and year 1 biopsies.||||||0.031||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.031
91483170|NCT00395538|182840003|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483171|NCT00395538|182840003|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.178||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.178
91483172|NCT00395538|182840004|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.BFR/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91489389|NCT02484690|182851573|SUPERIORITY||Difference in Least Squares Means|1.0||||0.8536|TWO_SIDED|80.0|-5.93|7.93||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||7.93|-5.93|0.8536
91630661|NCT00414973|183153587|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 24 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
91630662|NCT00414973|183153588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|2.2||0.2409||95.0|-1.87|7.13|||ANCOVA||Difference = Teriparatide minus Calcitonin|||7.13|-1.87|0.2409
91665764|NCT01494532|183225219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.826|TWO_SIDED|95.0|0.398|3.166|||Generalized Estimating Equations model|||||3.166|0.398|0.826
91665765|NCT01494532|183225219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.622||||0.233|TWO_SIDED|95.0|0.732|3.593|||Generalized Estimating Equations model|||||3.593|0.732|0.233
91630663|NCT00414973|183153589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|STANDARD_ERROR_OF_MEAN|1.9||0.6156||95.0|-4.85|2.92|||ANCOVA||Difference = Teriparatide minus Calcitonin|||2.92|-4.85|0.6156
91630664|NCT00414973|183153590|SUPERIORITY_OR_OTHER|||||||0.0026||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0026
91630665|NCT00414973|183153590|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||P-value for 24 Week Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0006
91630666|NCT01925014|183153629|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.013|||||TWO_SIDED|95.0|-0.008|0.033|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.033|-0.008|
91630667|NCT01925014|183153630|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.035|||||TWO_SIDED|95.0|-0.021|0.091|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.091|-0.021|
91665766|NCT01494532|183225219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.902|TWO_SIDED|95.0|0.439|2.065|||Generalized Estimating Equations model|||||2.065|0.439|0.902
91665767|NCT01494532|183225219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.866||||0.127|TWO_SIDED|95.0|0.837|4.158|||Generalized Estimating Equations model|||||4.158|0.837|0.127
91665768|NCT01494532|183225219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.362||||0.564|TWO_SIDED|95.0|0.477|3.888|||Generalized Estimating Equations model|||||3.888|0.477|0.564
91714273|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.472||0.0983||95.0|-8.97|0.77|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.77|-8.97|0.0983
91714274|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03|STANDARD_ERROR_OF_MEAN|2.415||0.0966||95.0|-8.78|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-8.78|0.0966
91714275|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.29|STANDARD_ERROR_OF_MEAN|2.548||0.0013||95.0|-13.31|-3.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.28|-13.31|0.0013
91792203|NCT01933789|183462225|SUPERIORITY||probit regression coefficient|-0.293||||0.372|TWO_SIDED|95.0|-1.139|0.553||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.553|-1.139|0.372
91630668|NCT04476108|183153682|SUPERIORITY||Posterior Mean Difference|-0.42|||||TWO_SIDED|95.0|-1.17|0.32|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.32|-1.17|
91630669|NCT04476108|183153683|SUPERIORITY||Posterior Mean Difference|-0.37|||||TWO_SIDED|95.0|-1.09|0.35|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.35|-1.09|
91630670|NCT04476108|183153684|SUPERIORITY||Posterior Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.69|0.15|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.15|-0.69|
91714276|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|2.437||0.0353||95.0|-9.96|-0.36|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.36|-9.96|0.0353
91483173|NCT00395538|182840004|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
91483174|NCT00395538|182840004|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.172||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.172
91483175|NCT00395538|182840005|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91527808|NCT06173570|182930682|SUPERIORITY||Mean Difference (Net)|-35.27|||<|0.001|TWO_SIDED|95.0|-43.61|-26.93|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 LDL-C values handled by the MMRM under MAR. Hierarchical testing (in the order of decreasing dose of study treatment) controls two-sided alpha = 0.05.||-26.93|-43.61|< 0.001
91630671|NCT04476108|183153685|SUPERIORITY||Posterior Mean Difference|-0.44|||||TWO_SIDED|95.0|-1.2|0.31|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.31|-1.20|
91630672|NCT04476108|183153686|SUPERIORITY||Posterior Mean Difference|-2.86|||||TWO_SIDED|95.0|-11.71|6.06|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||6.06|-11.71|
91483176|NCT00395538|182840005|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.018||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.018
91483177|NCT00395538|182840005|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.155||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.155
91483178|NCT00395538|182840006|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the year 1 biopsy.||||||0.72||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.720
91483179|NCT00395538|182840006|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.944||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.944
91483180|NCT00395538|182840006|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.73||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.730
91483181|NCT00395538|182840007|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the year 1 biopsy.||||||0.019||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.019
91483182|NCT00395538|182840007|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.017||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.017
91525614|NCT02247804|182926480|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.43|-1.09|0.3904
91525615|NCT02247804|182926481|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464||95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.01|-1.40|0.0464
91483183|NCT00395538|182840007|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.843||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.843
91483184|NCT00395538|182840008|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the year 1 biopsy.||||||0.013||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.013
91483185|NCT00395538|182840008|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the years 2 and 4 (combined) biopsy.||||||0.025||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.025
91483186|NCT00395538|182840008|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.608||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.608
91483187|NCT00395538|182840009|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Th values for both their baseline and year 1 biopsies.||||||0.043||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.043
91483188|NCT00395538|182840009|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.334||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.334
91525616|NCT02247804|182926481|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383||95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.47|-0.90|0.5383
91665769|NCT01494532|183225220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.861|TWO_SIDED|95.0|0.31|2.659|||Generalized Estimating Equations model|||||2.659|0.310|0.861
91665770|NCT01494532|183225220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.608||||0.277|TWO_SIDED|95.0|0.684|3.782|||Generalized Estimating Equations model|||||3.782|0.684|0.277
91665771|NCT01494532|183225220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.869|TWO_SIDED|95.0|0.461|2.5|||Generalized Estimating Equations model|||||2.500|0.461|0.869
91665772|NCT01494532|183225220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.14|TWO_SIDED|95.0|0.808|4.545|||Generalized Estimating Equations model|||||4.545|0.808|0.140
91792204|NCT01933789|183462226|SUPERIORITY||probit regression coefficient|-0.13||||0.501|TWO_SIDED|95.0|-0.63|0.369||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.369|-0.630|0.501
91792205|NCT01933789|183462227|SUPERIORITY||probit regression coefficient|-0.39||||0.192|TWO_SIDED|95.0|-1.16|0.38||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.380|-1.160|0.192
91630673|NCT04476108|183153687|SUPERIORITY||Posterior Mean Difference|0.35|||||TWO_SIDED|95.0|-0.09|0.78|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.78|-0.09|
91483189|NCT00395538|182840009|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.269||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Th change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Th, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.269
91483190|NCT00395538|182840010|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Ar values for both their baseline and year 1 biopsies.||||||0.358||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.358
91483191|NCT00395538|182840010|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.76||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.760
91483192|NCT00395538|182840010|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.57||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.570
91483193|NCT00395538|182840011|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.Ar values for both their baseline and year 1 biopsies.||||||0.166||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.166
91483194|NCT00395538|182840011|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.895||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.895
91489390|NCT02484690|182851573|SUPERIORITY||Difference in Least Squares Means|8.14||||0.2303|TWO_SIDED|80.0|-0.56|16.83||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||16.83|-0.56|0.2303
91630674|NCT04476108|183153688|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-188.46|187.97|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||187.97|-188.46|
91630675|NCT04476108|183153689|SUPERIORITY||Posterior Mean Difference|0.04|||||TWO_SIDED|95.0|-0.01|0.1|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.10|-0.01|
91792206|NCT01933789|183462228|SUPERIORITY||probit regression coefficient|-0.014||||0.94|TWO_SIDED|95.0|-0.489|0.461||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.461|-0.489|0.940
91525617|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
91792207|NCT01933789|183462229|SUPERIORITY||probit regression coefficient|-0.229||||0.47|TWO_SIDED|95.0|-1.044|0.587||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.587|-1.044|0.470
91483195|NCT00395538|182840011|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.282||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.282
91483196|NCT00395538|182840012|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
91483197|NCT00395538|182840012|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91483198|NCT00395538|182840012|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.68||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.680
91483199|NCT00395538|182840013|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the year 1 biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
91483200|NCT00395538|182840013|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
91489391|NCT02484690|182851573|SUPERIORITY||Difference in Least Squares Means|1.08||||0.8406|TWO_SIDED|80.0|-5.79|7.95||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||7.95|-5.79|0.8406
91630676|NCT00471276|183153690|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|8.4|||||TWO_SIDED|95.0|3.5|16.6|||Exact 2-sided confidence interval|||||16.6|3.5|
91792208|NCT01933789|183462230|SUPERIORITY||probit regression coefficient|-0.01||||0.955|TWO_SIDED|95.0|-0.474|0.454||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.454|-0.474|0.955
91792209|NCT01933789|183462231|SUPERIORITY||probit regression coefficient|-0.287||||0.303|TWO_SIDED|95.0|-1.005|0.431||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.431|-1.005|0.303
91483201|NCT00395538|182840013|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.904||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.904
91489392|NCT02484690|182851574|SUPERIORITY||Difference in Percentage of Participants|-0.77||||1|TWO_SIDED|80.0|-11.23|9.68||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||9.68|-11.23|1.0000
91630677|NCT00471276|183153691|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|10.8|||||TWO_SIDED|95.0|5.1|19.6|||Exact 2-sided confidence interval|||||19.6|5.1|
91792210|NCT03102190|183462243|OTHER||||||||||||||||||The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.|||
91792211|NCT01150474|183462276|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
91792212|NCT01150474|183462277|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
91792213|NCT01150474|183462278|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
91792214|NCT01150474|183462279|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
91792215|NCT01150474|183462280|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
91792216|NCT01150474|183462281|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
91792217|NCT01150474|183462282|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
91792218|NCT01150474|183462283|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
91792219|NCT01150474|183462284|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
91792220|NCT02581943|183462293|OTHER|||||||0.366|||||||Log Rank|||||||0.366
91630678|NCT01487863|183153711|SUPERIORITY|||||||0.2141|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.2141
91665773|NCT01494532|183225220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.689||||0.362|TWO_SIDED|95.0|0.547|5.218|||Generalized Estimating Equations model|||||5.218|0.547|0.362
91792221|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.327|||||||Wilcoxon (Mann-Whitney)|test for CD4+FoxP3||||||0.327
91792222|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.142|||||||Wilcoxon (Mann-Whitney)|test for MDSC||||||0.142
91792223|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.462||||||test for CD4+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.462
91792224|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.87||||||test for CD8+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.870
91792225|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.414||||||test for Plamacytoid DC|Wilcoxon (Mann-Whitney)|||||||0.414
91792226|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.121||||||test for Monocytes|Wilcoxon (Mann-Whitney)|||||||0.121
91792227|NCT02581943|183462294|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.624||||||test for T cells (CD3+)|Wilcoxon (Mann-Whitney)|||||||0.624
91792228|NCT02581943|183462295|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
91792229|NCT02581943|183462296|OTHER|||||||0.63|||||||Log Rank|||||||0.63
91792230|NCT02581943|183462297|OTHER|||||||0.692|||||||Log Rank|||||||0.692
91792231|NCT02581943|183462298|OTHER|||||||0.345|||||||Fisher Exact|||||||0.345
91792232|NCT02581943|183462299|OTHER|||||||0.917|||||||Kruskal-Wallis|Test for CD8+ICOS||||||0.917
91792233|NCT02581943|183462299|OTHER|||||||0.746|||||||Kruskal-Wallis|test for MDSC||||||0.746
91792234|NCT02581943|183462299|OTHER|||||||0.302||||||test for CD4+ICOS|Kruskal-Wallis|||||||0.302
91792235|NCT02581943|183462299|OTHER|||||||0.13|||||||Kruskal-Wallis|test for CD8+ICOS+||||||0.130
91792236|NCT02581943|183462299|OTHER|||||||0.628||||||test for Plamacytoid DC|Kruskal-Wallis|||||||0.628
91792237|NCT02581943|183462299|OTHER|||||||0.567||||||test for Monocytes|Kruskal-Wallis|||||||0.567
91792238|NCT02581943|183462299|OTHER|||||||0.311||||||test for T cells (CD3+)|Kruskal-Wallis|||||||0.311
91792239|NCT02197234|183462309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|77.08|||||TWO_SIDED|90.0|63.41|93.7|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||93.70|63.41|
91525618|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
91525619|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057|TWO_SIDED|95.0|-1.45|-0.25|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
91525620|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031|TWO_SIDED|95.0|-1.5|-0.31|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
91525621|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547|TWO_SIDED|95.0|-1.26|0.01|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
91665774|NCT01494532|183225221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.525|TWO_SIDED|95.0|0.266|1.965|||Generalized Estimating Equations model|||||1.965|0.266|0.525
91483202|NCT00395538|182840014|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
91483203|NCT00395538|182840014|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91483204|NCT00395538|182840014|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.01||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.010
91483205|NCT00395538|182840015|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the year 1 biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483206|NCT00395538|182840015|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91525622|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107|TWO_SIDED|95.0|-1.46|-0.19|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
91483207|NCT00395538|182840015|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
91525623|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.32||0.086|TWO_SIDED|95.0|-1.16|0.08|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
91525624|NCT02247804|182926482|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
91525625|NCT01187329|182926491|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|97.5|-2.87|0.48|||t-test, 2 sided|||||0.48|-2.87|0.11
91525626|NCT01187329|182926492|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.007|TWO_SIDED|97.5|-0.3|-0.01|||t-test, 2 sided|paired t-test||||-0.01|-0.3|0.007
91525627|NCT01187329|182926493|SUPERIORITY||Median Difference (Final Values)|-0.6||||0.57|TWO_SIDED|95.0|-2.6|1.5|||t-test, 2 sided|||||1.5|-2.6|0.57
91483208|NCT00395538|182840016|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
91483209|NCT00395538|182840016|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
91489393|NCT02484690|182851575|SUPERIORITY||Difference in Least Squares Means|12.65||||0.3798|TWO_SIDED|80.0|-5.81|31.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||31.11|-5.81|0.3798
91630679|NCT01810380|183153729|SUPERIORITY_OR_OTHER||Least square mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.1||0.056|TWO_SIDED|95.0|-8.2|0.1||For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.|Mixed Models Analysis|Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions||The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.||0.1|-8.2|0.0560
91630680|NCT01810380|183153729|SUPERIORITY_OR_OTHER||Least square mean difference|-8.0|STANDARD_ERROR_OF_MEAN|2.1||0.0002|TWO_SIDED|95.0|-12.2|-3.9|||Mixed Models Analysis|||||-3.9|-12.2|0.0002
91525628|NCT01187329|182926494|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.45|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.45
91525629|NCT00909480|182926502|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: 0.4%.|Mean Difference (Net)|0.3003||||||95.0|0.1427|0.458|||ANCOVA|Full analysis set, Model adjusted for: HbA1c at baseline, previous oral anti-diabetic treatment and country.||||0.4580|0.1427|
91665775|NCT01494532|183225221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.851||||0.13|TWO_SIDED|95.0|0.834|4.109|||Generalized Estimating Equations model|||||4.109|0.834|0.130
91630681|NCT03787095|183153757|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.71
91483210|NCT00395538|182840016|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.228||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.228
91483211|NCT00395538|182840017|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
91483212|NCT00395538|182840017|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
91483213|NCT00395538|182840017|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.67||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.670
91483214|NCT00395538|182840018|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MAR values for both their baseline and year 1 biopsies.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
91483215|NCT00395538|182840018|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483216|NCT00395538|182840018|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.712||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.712
91630682|NCT03787095|183153758|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||1.00
91630683|NCT03787095|183153759|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.33
91665776|NCT01494532|183225221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.992|TWO_SIDED|95.0|0.444|2.232|||Generalized Estimating Equations model|||||2.232|0.444|0.992
91483217|NCT00395538|182840019|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.OS/BS values for both their baseline and year 1 biopsies.||||||0.029||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.029
91483218|NCT00395538|182840019|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91630684|NCT02092324|183153835|SUPERIORITY|1-proportion test for greater than 10% difference.||||||0.002||||||p-value for Protocol-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.002
91630685|NCT02092324|183153835|SUPERIORITY|1-proportion test for greater than 10% difference||||||0.9||||||p-value is for IWG-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.90
91483219|NCT00395538|182840019|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.104||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.104
91483220|NCT00395538|182840020|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.ES/BS values for both their baseline and year 1 biopsies.||||||0.088||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.088
91483221|NCT00395538|182840020|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
91483222|NCT00395538|182840020|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.325||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.325
91527809|NCT06173570|182930682|SUPERIORITY||Mean Difference (Net)|-37.91|||<|0.001|TWO_SIDED|95.0|-46.31|-29.51|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 LDL-C values handled by the MMRM under MAR. Hierarchical testing (in the order of decreasing dose of study treatment) controls two-sided alpha = 0.05.||-29.51|-46.31|< 0.001
91630686|NCT02092324|183153838|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.|||||<|0.0001||||||p-value for protocol-defined objective response. p-value for IWG-defined objective response is 0.70|Clopper-Pearson method|||||||<0.0001
91665777|NCT01494532|183225221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.329|TWO_SIDED|95.0|0.674|3.248|||Generalized Estimating Equations model|||||3.248|0.674|0.329
91665778|NCT01494532|183225221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.907||||0.856|TWO_SIDED|95.0|0.315|2.61|||Generalized Estimating Equations model|||||2.610|0.315|0.856
91630687|NCT02092324|183153838|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.||||||0.7||||||p-value for IWG-defined objective response|Clopper-Pearson method|||||||0.70
91792240|NCT02197234|183462310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|91.46|||||TWO_SIDED|90.0|77.16|108.41|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||108.41|77.16|
91483223|NCT00395538|182840021|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 3 participants with non-missing Ec.AjAR values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483224|NCT00395538|182840021|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483225|NCT00395538|182840021|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.974||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.974
91483226|NCT00395538|182840022|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
91483227|NCT00395538|182840022|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.023||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.023
91483228|NCT00395538|182840022|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.288||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.288
91483229|NCT00395538|182840023|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MAR values for both their baseline and year 1 biopsies.||||||0.202||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.202
91665779|NCT01494532|183225223|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
91630688|NCT02092324|183153848|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic)||||||0.003||||||p-value for protocol-defined objective response.|Chi-squared, Corrected|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for protocol-defined objective response||||0.003
91483230|NCT00395538|182840023|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.486||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.486
91483231|NCT00395538|182840023|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.535||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.535
91483232|NCT00395538|182840024|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.OS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
91483233|NCT00395538|182840024|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
91483234|NCT00395538|182840024|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.328||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.328
91483235|NCT00395538|182840025|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.ES/BS values for both their baseline and year 1 biopsies.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
91527810|NCT06173570|182930682|SUPERIORITY||Mean Difference (Net)|-45.17|||<|0.001|TWO_SIDED|95.0|-53.47|-36.86|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 LDL-C values handled by the MMRM under MAR. Hierarchical testing (in the order of decreasing dose of study treatment) controls two-sided alpha = 0.05.||-36.86|-53.47|< 0.001
91665780|NCT01494532|183225223|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
91665781|NCT01494532|183225223|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
91665782|NCT01494532|183225223|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
91792241|NCT02119676|183462341|OTHER||Hazard Ratio (HR)|1.04||||0.588|TWO_SIDED|95.0|0.73|1.49||1-sided|Log Rank|Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.|Estimated using a Cox regression model with Efron's method used for ties, stratified by mGPS score and geographical region|||1.49|0.73|0.588
91525630|NCT00393523|182926535|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||95.2|92.1|97.1||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.1|92.1|<0.001
91630689|NCT02092324|183153848|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square)||||||0.1||||||p-value for IWG-defined objective response = 0.1|Fisher Exact|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for IWG-defined objective response||||0.1
91630690|NCT00499460|183153862|SUPERIORITY|The primary hypothesis being tested is that garlic powder treatment increases metabolic clearance of oxycodone through enzyme induction and results in lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is oxycodone oral clearance. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
91792242|NCT02119676|183462341|OTHER||Hazard Ratio (HR)|0.77||||0.136|TWO_SIDED|95.0|0.48|1.23||1-sided|Log Rank|Log rank test stratified by geographical region.|Estimated using Cox regression model with Efron's method used for ties, stratified by geographical region|||1.23|0.48|0.136
91665783|NCT01494532|183225223|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
91792243|NCT00219544|183462347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.25||0.0018||95.0|-1.27|-0.3|||ANCOVA||Difference = pregabalin minus placebo|The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level.||-0.30|-1.27|0.0018
91792244|NCT00219544|183462350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.22||0.001||95.0|-1.15|-0.3|||ANCOVA||pregabalin minus placebo|Week 5||-0.30|-1.15|0.0010
91792245|NCT00219544|183462350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.41|-0.53|||ANCOVA||pregabalin minus placebo|Week 6||-0.53|-1.41|<.0001
91792246|NCT00219544|183462350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 7||-0.47|-1.39|<.0001
91792247|NCT00219544|183462350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 8||-0.47|-1.39|<.0001
91792248|NCT00219544|183462350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0022||95.0|-1.14|-0.25|||ANCOVA||pregabalin minus placebo|Week 9||-0.25|-1.14|0.0022
91792249|NCT00219544|183462356|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0031||95.0|-1.18|-0.24|||ANCOVA|||||-0.24|-1.18|0.0031
91792250|NCT00219544|183462359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.22||0.0177||95.0|-0.94|-0.09|||ANCOVA||pregabalin minus placebo|Week 5||-0.09|-0.94|0.0177
91792251|NCT00219544|183462359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.31|-0.44|||ANCOVA||pregabalin minus placebo|Week 6||-0.44|-1.31|<.0001
91792252|NCT00219544|183462359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0005||95.0|-1.28|-0.36|||ANCOVA||pregabalin minus placebo|Week 7||-0.36|-1.28|0.0005
91792253|NCT00219544|183462359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0003||95.0|-1.31|-0.39|||ANCOVA||pregabalin minus placebo|Week 8||-0.39|-1.31|0.0003
91792254|NCT00219544|183462359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.22||0.0011||95.0|-1.18|-0.3|||ANCOVA||pregabalin minus placebo|Week 9||-0.30|-1.18|0.0011
91792255|NCT00219544|183462360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.0|STANDARD_ERROR_OF_MEAN|3.3||0.0069||95.0|-15.5|-2.5|||ANCOVA|||||-2.5|-15.5|0.0069
91792256|NCT00219544|183462361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0023||95.0|-2.1|-0.5|||ANCOVA||pregabalin minus placebo|HADS-A||-0.5|-2.1|0.0023
91792257|NCT00219544|183462361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0013||95.0|-1.9|-0.5|||ANCOVA||pregabalin minus placebo|HADS-D||-0.5|-1.9|0.0013
91792258|NCT00219544|183462362|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.98|STANDARD_ERROR_OF_MEAN|3.42||0.0828||95.0|-0.79|12.75|||ANCOVA||pregabalin minus placebo|Impact||12.75|-0.79|0.0828
91792259|NCT00219544|183462362|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.49|STANDARD_ERROR_OF_MEAN|2.75||0.0197||95.0|1.05|11.94|||ANCOVA||pregabalin minus placebo|Satisfaction||11.94|1.05|0.0197
91792260|NCT00219544|183462363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278||95.0|||||Mantel Haenszel|||The distribution of the responses to the PGIC at EOT was compared between the 2 treatment groups using the 7 categories of the PGIC.||||0.0278
91792261|NCT00219544|183462364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.26||0.0049||95.0|-1.28|-0.23|||ANCOVA|||Pain interference||-0.23|-1.28|0.0049
91792262|NCT00219544|183462364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|0.26||0.0037||95.0|-1.29|-0.25|||ANCOVA|||Pain severity||-0.25|-1.29|0.0037
91792263|NCT00219544|183462365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0719||95.0|0.0|0.11|||ANCOVA||pregabalin minus placebo|Health State Profile||0.11|-0.00|0.0719
91792264|NCT00219544|183462365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|2.54||0.418||95.0|-2.96|7.1|||ANCOVA||pregabalin minus placebo|Visual Analog Scale||7.10|-2.96|0.4180
91483236|NCT00395538|182840025|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
91483237|NCT00395538|182840025|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.789||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.789
91483238|NCT00395538|182840026|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.AjAR values for both their baseline and year 1 biopsies.||||||0.651||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.651
91483239|NCT00395538|182840026|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.58||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.580
91483240|NCT00395538|182840026|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.338||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.338
91483241|NCT00395538|182840027|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the year 1 biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
91483242|NCT00395538|182840027|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the years 2 and 4 (combined) biopsy.||||||0.11||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.110
91483243|NCT00395538|182840027|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.764||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.764
91665784|NCT01494532|183225224|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
91792265|NCT05038904|183462370|SUPERIORITY|We estimated that 10 subjects allowed for 80% power to detect a 3-fold increase (1.1 natural log units; i.e. 1 food dose escalation) in the threshold food dose using a paired t test with p\<0.05. For this sample size determination, the primary endpoint was assumed to be normally distributed with a standard deviation of 1.1 natural log units.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91792266|NCT05038904|183462371|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||||||0.0014
91792267|NCT05038904|183462372|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91792268|NCT05038904|183462373|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Participants' ex vivo basophil activation during acalabrutinib treatment was compared to their own baseline level.||||0.002
91792269|NCT00873873|183462381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANOVA|||Is there a difference in airway wall thickness among the 4 groups?||||0.2
91792270|NCT02207946|183462383|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.28||0.144|TWO_SIDED|95.0|-1.02|0.16|||ANCOVA|||Least square (LS) means are from analysis of covariance (ANCOVA) with treatment and site included as fixed factors and baseline included as covariate.||0.16|-1.02|0.144
91792271|NCT04035486|183462425|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.79|0.49|<0.0001
91792272|NCT04035486|183462426|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0002|TWO_SIDED|95.0|0.48|0.8|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.80|0.48|0.0002
91792273|NCT04035486|183462431|OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|88.43|100.0|||Clopper-Pearson|||A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.||100.00|88.43|
91792274|NCT04035486|183462432|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5238|TWO_SIDED|95.0|0.65|1.24|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).|An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.|1.24|0.65|0.5238
91792275|NCT04035486|183462434|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0261|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic||And odds ratio of greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.44|1.06|0.0261
91792276|NCT04035486|183462436|SUPERIORITY||Least Square Mean Difference|-3.36||||0.1067|TWO_SIDED|95.0|-7.44|0.72|||ANCOVA||A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.72|-7.44|0.1067
91792277|NCT04035486|183462437|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4483|TWO_SIDED|95.0|0.63|2.81|||Regression, Logistic||An odds ratio greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.81|0.63|0.4483
91792278|NCT04035486|183462438|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0132|TWO_SIDED|95.0|0.52|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.52|0.0132
91792279|NCT04035486|183462439|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0159|TWO_SIDED|95.0|0.56|0.94|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.94|0.56|0.0159
91792280|NCT04035486|183462440|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0157|TWO_SIDED|95.0|0.51|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.51|0.0157
91792281|NCT04035486|183462447|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.83|||Cox proportional hazards model||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.83|0.44|
91792282|NCT04035486|183462448|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9|||||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.90|0.44|
91792283|NCT01730937|183462456|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0554|TWO_SIDED|90.0|0.59|1.01|||Log Rank||Reference arm = Sorafenib Alone|Original design: Hypothesized 28% reduction (HR=0.72) with SBRT (corresponds to median OS = 14.5 months). Assuming an exponential distribution and constant hazards, 292 patients were required to reach 238 OS events, with 80% statistical power, a 1-sided α of 0.05. Revised design (see limitations/caveats): For same above hypotheses, at least 155 OS events from 193 randomized patients provided 65% statistical power, with a 1-sided α of 0.05.||1.01|0.59|0.0554
91792284|NCT01730937|183462457|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.034|TWO_SIDED|95.0|0.48|0.99||Two-sided significance level = 0.05|Gray's test||Reference arm = Sorafenib Alone|||0.99|0.48|0.034
91792285|NCT01730937|183462458|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0001|TWO_SIDED|95.0|0.4|0.75||Two-sided significance level=0.05|Log Rank||Reference arm = Sorafenib Alone|||0.75|0.40|0.0001
91792286|NCT03947684|183462463|OTHER|Generalized linear model (GLM) with log link function and exchangeable correlation structure.|||||>|0.05|||||||F-test|||Significance was accepted for p values \<0.05.||||>0.05
91792287|NCT03947684|183462464|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
91483244|NCT00395538|182840028|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the year 1 biopsy.||||||0.227||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.227
91483245|NCT00395538|182840028|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the years 2 and 4 (combined) biopsy.||||||0.194||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.194
91483246|NCT00395538|182840028|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.434||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.434
91483247|NCT00395538|182840029|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
91483248|NCT00395538|182840029|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
91483249|NCT00395538|182840029|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.787||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.787
91483250|NCT00395538|182840030|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the year 1 biopsy.||||||0.082||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.082
91483251|NCT00395538|182840030|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the years 2 and 4 (combined) biopsy.||||||0.057||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.057
91483252|NCT00395538|182840030|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.547||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.547
91527811|NCT06173570|182930682|SUPERIORITY||Mean Difference (Net)|-50.7|||<|0.001|TWO_SIDED|95.0|-59.03|-42.37|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 LDL-C values handled by the MMRM under MAR. Hierarchical testing (in the order of decreasing dose of study treatment) controls two-sided alpha = 0.05.||-42.37|-59.03|< 0.001
91665785|NCT01494532|183225224|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
91665786|NCT01494532|183225224|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.230
91665787|NCT01494532|183225224|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
91483253|NCT00395538|182840031|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the baseline and the year 1 biopsy.||||||0.922||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.922
91483254|NCT00395538|182840031|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 and the years 2 and 4 (combined) biopsy.||||||0.342||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.342
91483255|NCT00395538|182840031|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.449||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.449
91483256|NCT01659658|182840087|SUPERIORITY||Odds Ratio (OR)|1.1|||=|0.7623|TWO_SIDED|95.0|0.6|2.01||P-value was calculated from the unstratified Cochran-Mantel-Haenszel (CMH) test to compare hematologic response rate between the treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% confidence interval (CI) for the odds ratio was based on the Wald approximation.|Statistical analysis was planned to be collected and analyzed in a combined manner for the non-ixazomib arm groups versus ixazomib group in this outcome measure.||2.01|0.60|=0.7623
91483257|NCT01659658|182840088|SUPERIORITY||Odds Ratio (OR)|0.75|||=|0.351|TWO_SIDED|95.0|0.41|1.38||P-value was calculated from the unstratified CMH test to make comparisons between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||1.38|0.41|=0.3510
91483258|NCT01659658|182840090|SUPERIORITY||Hazard Ratio (HR)|0.82|||=|0.389|TWO_SIDED|95.0|0.52|1.29||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.29|0.52|=0.389
91483259|NCT01659658|182840091|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.135|TWO_SIDED|95.0|0.52|1.09||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.09|0.52|=0.135
91483260|NCT01659658|182840092|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2421|TWO_SIDED|95.0|0.48|1.21||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.21|0.48|0.2421
91483261|NCT01659658|182840093|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.036|TWO_SIDED|95.0|0.39|0.97||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.97|0.39|=0.036
91483262|NCT01659658|182840094|SUPERIORITY||Odds Ratio (OR)|1.69|||=|0.226|TWO_SIDED|95.0|0.72|3.99||P-value was calculated from the unstratified CMH test to compare vital organ response rate between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was calculated from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||3.99|0.72|=0.2260
91483263|NCT01659658|182840095|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.163|TWO_SIDED|95.0|0.52|1.12||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|||1.12|0.52|=0.163
91483264|NCT01659658|182840098|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.025|TWO_SIDED|95.0|0.49|0.96||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.96|0.49|=0.025
91483265|NCT01659658|182840099|SUPERIORITY||Hazard Ratio (HR)|0.58|||=|0.01|TWO_SIDED|95.0|0.38|0.88||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.88|0.38|=0.010
91483266|NCT01557894|182840157|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
91665788|NCT01494532|183225224|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
91665789|NCT01494532|183225225|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
91665790|NCT01494532|183225225|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
91665791|NCT01494532|183225225|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
91630691|NCT00499460|183153863|SUPERIORITY|The secondary hypothesis being tested is that powder garlic treatment lowers Cold Pressor Test tolerance (i.e., diminished analgesic response) after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is log Tolerance AUC. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
91630692|NCT00499460|183153864|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total SSE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
91630693|NCT00499460|183153865|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total CASE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
91630694|NCT00499460|183153866|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||The secondary hypothesis being tested is that garlic powder induces CYP3A-mediated metabolism resulting in a lower oral midazolam AUC.||||>0.05
91630695|NCT00499460|183153867|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment induces intestinal P-glycoprotein, reduces the bioavailability and hence AUC of orally administered digoxin.|||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||||||>0.05
91630696|NCT00814307|183153882|SUPERIORITY_OR_OTHER||Percent difference|39.04|||<|0.0001|TWO_SIDED|95.0|29.12|48.95||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||48.95|29.12|<0.0001
91630697|NCT00814307|183153882|SUPERIORITY_OR_OTHER||Percent difference|33.08|||<|0.0001|TWO_SIDED|95.0|23.04|43.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||43.13|23.04|<0.0001
91630698|NCT00814307|183153883|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.27||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.27|-0.50|<.0001
91483267|NCT01557894|182840158|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
91630699|NCT00814307|183153883|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.2||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.20|-0.43|<0.0001
91630700|NCT00814307|183153884|SUPERIORITY_OR_OTHER||Percent difference|5.24||||0.0728|TWO_SIDED|95.0|-0.49|10.96||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||10.96|-0.49|0.0728
91630701|NCT00814307|183153884|SUPERIORITY_OR_OTHER||Percent difference|1.31||||0.6193|TWO_SIDED|95.0|-3.85|6.46||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||6.46|-3.85|0.6193
91792288|NCT03947684|183462464|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||<0.05
91483268|NCT01557894|182840159|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.||||||<0.01
91483269|NCT01557894|182840160|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
91483270|NCT01557894|182840161|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
91483271|NCT03402659|182840162|OTHER||Mean Difference (Final Values)|-0.06098|STANDARD_ERROR_OF_MEAN|0.105548||0.564|TWO_SIDED|95.0|-0.26973|0.14777|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.14777|-0.26973|0.564
91483272|NCT03402659|182840163|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.72||0.823|TWO_SIDED|95.0|-6.0|4.8|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||4.8|-6.0|0.823
91483273|NCT03402659|182840164|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.806|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.6|-0.4|0.806
91483274|NCT03402659|182840165|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.489|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.5|-1.0|0.489
91525631|NCT00393523|182926535|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||97.6|91.6|97.3||Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024). Since only one group met the criteria, that group was retested at α=.012.|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.3|91.6|<0.001
91525632|NCT00393523|182926535|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|91.6||||0.19||95.2|88.0|94.4||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||94.4|88.0|0.19
91525633|NCT00393523|182926536|SUPERIORITY_OR_OTHER||Seroprotection Rate (SPR)|97.3||||||95.0|95.0|98.8|||||"Exact binomial confidence interval~Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL"|The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.||98.8|95.0|
91525634|NCT02237508|182926572|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|138.87|||<|0.001|TWO_SIDED|90.0|129.09|149.39|||Mixed Models Analysis|||||149.39|129.09|<0.001
91525635|NCT02237508|182926572|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|136.18|||<|0.001|TWO_SIDED|90.0|126.13|147.04|||Mixed Models Analysis|||||147.04|126.13|<0.001
91630702|NCT01256918|183153928|SUPERIORITY_OR_OTHER||incidence|0.0|||>|0.05|||||||incidence|||"Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture."||||>0.05
91714277|NCT00676403|183320239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.469||0.0006||95.0|-13.4|-3.67|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.67|-13.40|0.0006
91483275|NCT03402659|182840166|OTHER||Mean Difference (Final Values)|-18.8|STANDARD_ERROR_OF_MEAN|8.6||0.031|TWO_SIDED|95.0|-35.8|-1.8|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-1.8|-35.8|0.031
91483276|NCT03402659|182840167|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.79||0.012|TWO_SIDED|95.0|-3.6|-0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-0.5|-3.6|0.012
91630703|NCT01256918|183153929|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.850958|||<|0.05|||||||pearson correlation coefficient|||null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chop||||<0.05
91525636|NCT02237508|182926573|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|119.73||||0.001|TWO_SIDED|90.0|109.4|131.03|||Mixed Models Analysis|||||131.03|109.40|0.001
91483277|NCT03402659|182840168|OTHER||Mean Difference (Final Values)|-117.4|STANDARD_ERROR_OF_MEAN|314.0||0.709|TWO_SIDED|95.0|-738.9|504.2|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||504.2|-738.9|0.709
91630704|NCT01256918|183153930|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.842617|||<|0.05|||||||pearson correlation coefficient|||"Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip."||||<0.05
91630705|NCT01256918|183153931|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.111166|||>|0.05|||||||pearson correlation coefficient|||null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsification||||>0.05
91630706|NCT03073200|183153936|SUPERIORITY||Mean Difference (Final Values)|63.7|||<|0.001|TWO_SIDED|95.0|51.0|76.4|||Fisher Exact|||||76.4|51.0|<0.001
91483278|NCT03402659|182840169|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|16.03||0.192|TWO_SIDED|95.0|-52.7|10.7|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||10.7|-52.7|0.192
91630707|NCT03073200|183153937|SUPERIORITY||Mean Difference (Final Values)|70.2|||<|0.001|TWO_SIDED|95.0|59.3|81.0|||Fisher Exact|||||81|59.3|<0.001
91630708|NCT03073200|183153938|SUPERIORITY||Mean Difference (Final Values)|72.9|||<|0.001|TWO_SIDED|95.0|63.3|82.5|||Fisher Exact|||||82.5|63.3|<0.001
91630709|NCT03073200|183153939|SUPERIORITY||Mean Difference (Final Values)|50.4|||<|0.001|TWO_SIDED|95.0|40.6|60.2|||Fisher Exact|||||60.2|40.6|<0.001
91630710|NCT03073200|183153940|SUPERIORITY||Mean Difference (Final Values)|47.8|||<|0.001|TWO_SIDED|95.0|38.0|57.6|||Fisher Exact|||||57.6|38.0|<0.001
91630711|NCT03073200|183153941|SUPERIORITY||Mean Difference (Final Values)|45.0|||<|0.001|TWO_SIDED|95.0|33.2|56.8|||Fisher Exact|||||56.8|33.2|<0.001
91630712|NCT03073200|183153942|SUPERIORITY||Mean Difference (Final Values)|40.7|||<|0.001|TWO_SIDED|95.0|29.3|52.0|||Fisher Exact|||||52.0|29.3|<0.001
91630713|NCT03073200|183153943|SUPERIORITY||Mean Difference (Final Values)|51.1|||<|0.001|TWO_SIDED|95.0|35.3|66.9|||Fisher Exact|||||66.9|35.3|<0.001
91630714|NCT03073200|183153944|SUPERIORITY||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|27.0|55.2|||Fisher Exact|||||55.2|27.0|<0.001
91630715|NCT03073200|183153945|SUPERIORITY||Mean Difference (Final Values)|-17.04|STANDARD_ERROR_OF_MEAN|5.747||0.005|TWO_SIDED|95.0|-28.7|-5.38|||Mixed Models Analysis|||||-5.38|-28.70|0.005
91630716|NCT03073200|183153946|SUPERIORITY||Mean Difference (Final Values)|-15.36|STANDARD_ERROR_OF_MEAN|1.682|<|0.001|TWO_SIDED|95.0|-18.69|-12.04|||Mixed Models Analysis|||||-12.04|-18.69|<0.001
91630717|NCT03073200|183153947|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_DEVIATION|3.853||0.006|TWO_SIDED|95.0|-20.11|-3.9|||Mixed Models Analysis|||||-3.90|-20.11|0.006
91630718|NCT03073200|183153950|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.089|TWO_SIDED|95.0|0.1|41.7|||Fisher Exact|||||41.7|0.1|0.089
91630719|NCT03073200|183153951|SUPERIORITY||Mean Difference (Final Values)|23.0||||0.07|TWO_SIDED|95.0|0.6|45.4|||Fisher Exact|||||45.4|0.6|0.070
91630720|NCT03227224|183153956|SUPERIORITY||Difference of Least Square Means|0.9||||0.724|TWO_SIDED|90.0|-3.12|4.82|||Mixed model for repeated measures (MMRM)|||||4.82|-3.12|0.724
91630721|NCT03227224|183153956|SUPERIORITY||Difference of Least Square Means|-3.1||||0.083|TWO_SIDED|90.0|-6.13|-0.16|||MMRM|||||-0.16|-6.13|0.083
91630722|NCT03227224|183153956|SUPERIORITY||Difference of Least Square Means|-1.5||||0.424|TWO_SIDED|90.0|-4.7|1.63|||MMRM|||||1.63|-4.70|0.424
91483279|NCT03402659|182840170|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|11.43||0.068|TWO_SIDED|95.0|-43.6|1.6|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||1.6|-43.6|0.068
91665792|NCT01494532|183225225|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
91483280|NCT03402659|182840171|OTHER||Mean Difference (Final Values)|-110.1|STANDARD_ERROR_OF_MEAN|77.11||0.156|TWO_SIDED|95.0|-262.7|42.4|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||42.4|-262.7|0.156
91483281|NCT03402659|182840172|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.59|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.0|-0.0|0.590
91483282|NCT02128828|182840178|SUPERIORITY|||||||0.0079|||||||Wilcoxon (Mann-Whitney)|||||||0.0079
91483283|NCT00090051|182840180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0218|TWO_SIDED|95.0|0.6|0.96|||Log Rank|non-stratified|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.||0.96|0.60|0.0218
91483284|NCT00090051|182840181|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Log Rank|non-stratified||||||0.2874
91483285|NCT00090051|182840183|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Log Rank|non-stratified||||||0.0002
91483286|NCT00090051|182840186|SUPERIORITY_OR_OTHER|||||||0.8842||95.0|||||Log Rank|non-stratified||||||0.8842
91665793|NCT01494532|183225225|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
91483287|NCT00090051|182840188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Log Rank|||||0.80|0.54|<.0001
91483288|NCT00090051|182840189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5976|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||||1.19|0.74|0.5976
91483289|NCT00090051|182840190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.79|||Log Rank|||||0.79|0.54|<.0001
91483290|NCT00090051|182840191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0005|TWO_SIDED|95.0|1.39|3.35|||Chi-squared|||||3.35|1.39|0.0005
91483291|NCT00090051|182840192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3085|TWO_SIDED|95.0|0.46|1.28|||Log Rank|||||1.28|0.46|0.3085
91483292|NCT00090051|182840193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0007|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||||0.84|0.51|0.0007
91483293|NCT00090051|182840194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0002|TWO_SIDED|95.0|0.55|0.84|||Log Rank|||||0.84|0.55|0.0002
91483294|NCT02840240|182840209|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Mean Difference (Final Values)|-0.19||||0.003|TWO_SIDED|95.0|-1.07|0.69|||Regression, Linear|||||0.69|-1.07|0.003
91483295|NCT02840240|182840210|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|2.12||||0.77|TWO_SIDED|95.0|0.21|18.54|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic main campus.||18.54|0.21|0.77
91527812|NCT06173570|182930683|SUPERIORITY||Mean Difference (Net)|-33.85|||<|0.001|TWO_SIDED|95.0|-42.34|-25.37|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-25.37|-42.34|< 0.001
91665794|NCT01494532|183225226|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.998
91525637|NCT02237508|182926573|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|129.62|||<|0.001|TWO_SIDED|90.0|117.33|143.2|||Mixed Models Analysis|||||143.20|117.33|<0.001
91525638|NCT02237508|182926574|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|218.13|||<|0.001|TWO_SIDED|90.0|194.02|245.24|||Mixed Models Analysis|||||245.24|194.02|<0.001
91525639|NCT02237508|182926574|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|200.66|||<|0.001|TWO_SIDED|90.0|174.3|231.01|||Mixed Models Analysis|||||231.01|174.30|<0.001
91525640|NCT02237508|182926575|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|126.17|||<|0.001|TWO_SIDED|90.0|115.93|137.32|||Mixed Models Analysis|||||137.32|115.93|<0.001
91525641|NCT02237508|182926575|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|117.08||||0.004|TWO_SIDED|90.0|107.05|128.05|||Mixed Models Analysis|||||128.05|107.05|0.004
91525642|NCT03300570|182926604|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91525643|NCT02296190|182926611|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Statistical analysis was performed with the Fisher's exact test to compare the conversion rate between the MSP-2017 groups and the placebo group.||||<0.05
91525644|NCT00717314|182926624|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
91525645|NCT00717314|182926627|SUPERIORITY_OR_OTHER|||||||0.374|||||||ANOVA|||Between group comparison at Baseline||||0.374
91525646|NCT00717314|182926627|SUPERIORITY_OR_OTHER|||||||0.685||||||Analysis of covariance (ANCOVA) model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.685
91525647|NCT00717314|182926627|SUPERIORITY_OR_OTHER|||||||0.722||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.722
91665795|NCT01494532|183225226|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.017
91665796|NCT01494532|183225226|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.312
91665797|NCT01494532|183225226|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
91525648|NCT00717314|182926627|SUPERIORITY_OR_OTHER|||||||0.432||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.432
91525649|NCT00717314|182926628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-5.342|5.561||||||||5.561|-5.342|
91525650|NCT00717314|182926629|SUPERIORITY_OR_OTHER|||||||0.616||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.616
91525651|NCT00717314|182926629|SUPERIORITY_OR_OTHER|||||||0.334||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.334
91665798|NCT01494532|183225226|SUPERIORITY_OR_OTHER|||||||0.659|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.659
91525652|NCT00717314|182926629|SUPERIORITY_OR_OTHER|||||||0.267||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.267
91525653|NCT00717314|182926629|SUPERIORITY_OR_OTHER|||||||0.764|||||||ANCOVA|ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.||Change from Baseline at Week 52||||0.764
91525654|NCT00717314|182926630|SUPERIORITY_OR_OTHER|||||||1|||||||ANCOVA|||||||1.000
91525655|NCT01483937|182926631|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANOVA|||||||.533
91665799|NCT01494532|183225227|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.337
91665800|NCT01494532|183225227|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.126
91665801|NCT01494532|183225227|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.283
91665802|NCT01494532|183225227|SUPERIORITY_OR_OTHER|||||||0.148|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.148
91665803|NCT01494532|183225227|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.581
91525656|NCT00682643|182926645|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.395
91525657|NCT00682643|182926646|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.342
91525658|NCT03238300|182926663|SUPERIORITY||partial eta squared|0.02|||>|0.05|TWO_SIDED|95.0|0.0|0.22||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo)|Mixed Models Analysis|Random intercepts were used||"With 31 participants, the study has 99% power to detect such effects on glutamate levels (calculated based on d =1.13 \[reported in Schmaal et al., 2012\], α = 0.05, two-tailed).~We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline metabolite levels and brain tissue composition \[GM:BM = GM/(GM+WM)\], cannabis use (days), and alcohol use disorder status (Yes/No) were included as covariates."||0.22|0.00|>0.05
91525659|NCT03238300|182926664|SUPERIORITY||||||>|0.05||||||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo) for all ROIs.|Mixed Models Analysis|Random intercepts were used for all models.||Contrast of interest was alcohol beverages vs. non-alcohol beverages. We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline reactivity levels for each ROI, cannabis use (days), and an alcohol use covariate (quantity, frequency, AUD status, or AUD severity - depending on which best fit the model) were included as covariates. ROIs included were (left and right hemisphere): amygdala, caudate, insula, putamen, and nucleus accumbens.||||>0.05
91525660|NCT04064242|182926685|OTHER|A Bayesian model for repeated measurements including data collected at Weeks 4, 8, 12 and 16 was applied to compare FVC between CMK389 and placebo groups.|Posterior estimate treatment difference|-1.49|STANDARD_DEVIATION|1.62||0.1804|TWO_SIDED|80.0|-3.56|0.6|||Bayesian analysis|Posterior probability that treatment is better than placebo.|80% credible intervals are reported on the treatment difference|||0.60|-3.56|0.1804
91525661|NCT04064242|182926691|SUPERIORITY||Median Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.783|TWO_SIDED|80.0|-0.09|0.02|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.02|-0.09|0.783
91525662|NCT04064242|182926692|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.664||0.608|TWO_SIDED|80.0|-1.05|0.68|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.68|-1.05|0.608
91525663|NCT04064242|182926693|SUPERIORITY||Median Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|13.126||0.479|TWO_SIDED|80.0|-16.35|17.76|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||17.76|-16.35|0.479
91525664|NCT04512066|182926705|OTHER||treatment effect|0.6||||0.849|TWO_SIDED|90.0|-4.58|5.78|||Mixed Models Analysis|||||5.78|-4.58|0.849
91525665|NCT04512066|182926705|OTHER||treatment effect|-2.83||||0.362|TWO_SIDED|90.0|-7.96|2.29|||Mixed Models Analysis|||||2.29|-7.96|0.362
91525666|NCT04512066|182926705|OTHER||treatment effect|-10.45||||0.001|TWO_SIDED|90.0|-15.46|-5.43|||Mixed Models Analysis|||||-5.43|-15.46|0.001
91630723|NCT03782376|183154001|SUPERIORITY||Difference in percentage|11.5||||0.089|TWO_SIDED|95.0|-1.5|24.5||Threshold for significance was 0.05 level.|Cochran-Mantel Haenszel-chi-square test|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||24.5|-1.5|0.089
91630724|NCT03782376|183154002|SUPERIORITY||Difference in percentage|5.9||||0.338|TWO_SIDED|95.0|-6.0|17.8|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||17.8|-6.0|0.338
91630725|NCT03782376|183154003|SUPERIORITY||Difference in percentage|7.1||||0.3|TWO_SIDED|95.0|-6.0|20.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||20.2|-6.0|0.300
91665804|NCT01494532|183225228|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.486
91525667|NCT00971750|182926731|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||Chi-squared|||||||0.763
91525668|NCT00971750|182926733|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91525669|NCT01657266|182926734|SUPERIORITY_OR_OTHER|||||||1|||||||Pearson´s Chi-square test|||||||1.00
91525670|NCT00445679|182926744|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-3.13|||||TWO_SIDED|95.0|-12.62|6.37||||||||6.37|-12.62|
91525671|NCT00445679|182926744|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|0.88|||||TWO_SIDED|95.0|-8.5|10.25||||||||10.25|-8.50|
91525672|NCT00445679|182926744|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-2.17|||||TWO_SIDED|95.0|-11.68|7.33||||||||7.33|-11.68|
91525673|NCT00445679|182926745|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.714
91525674|NCT00445679|182926745|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.653
91525675|NCT00445679|182926745|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.881
91525676|NCT00445679|182926746|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.450
91525677|NCT00445679|182926746|SUPERIORITY_OR_OTHER|||||||0.452||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.452
91525678|NCT00445679|182926746|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.850
91527813|NCT06173570|182930683|SUPERIORITY||Mean Difference (Net)|-36.73|||<|0.001|TWO_SIDED|95.0|-45.3|-28.17|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-28.17|-45.30|< 0.001
91665805|NCT01494532|183225228|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
91525679|NCT01316770|182926751|SUPERIORITY|The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.||||||0.236||||||No corrections were made for multiple comparisons because there was only one primary hypothesis.|one-sided Paired t-test|||The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction \[that was specified in the statistical analysis plan (SAP) for the mixed model\] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.||||0.236
91630726|NCT03782376|183154004|SUPERIORITY||Difference in percentage|6.4||||0.314|TWO_SIDED|95.0|-5.8|18.6|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||18.6|-5.8|0.314
91630727|NCT03782376|183154005|SUPERIORITY||Difference in percentage|18.5||||0.004|TWO_SIDED|95.0|6.8|30.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||30.2|6.8|0.004
91630728|NCT03039192|183154045|SUPERIORITY||Difference of Least Square Means|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.56|-1.09|||ANCOVA|||||-1.09|-6.56|0.006
91630729|NCT03277794|183154070|OTHER||Odds Ratio (OR)|2.28|STANDARD_ERROR_OF_MEAN|0.89||0.354|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.354
91630730|NCT03277794|183154070|OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.95||0.465|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.465
91630731|NCT03277794|183154071|OTHER||Odds Ratio (OR)|2.31|STANDARD_ERROR_OF_MEAN|0.59||0.159|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.159
91630732|NCT03277794|183154071|OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.64||0.2|TWO_SIDED||||||Regression, Linear|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.200
91630733|NCT03277794|183154072|OTHER||Odds Ratio (OR)|3.18|STANDARD_ERROR_OF_MEAN|0.74||0.121|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.121
91630734|NCT03277794|183154072|OTHER||Odds Ratio (OR)|3.63|STANDARD_ERROR_OF_MEAN|0.85||0.134|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.134
91630735|NCT03277794|183154073|OTHER|||||||0.899||||||Unadjusted.|Regression, Linear|||||||0.899
91630736|NCT03277794|183154073|OTHER|||||||0.128||||||Unadjusted|Regression, Linear|||||||0.128
91630737|NCT03277794|183154074|OTHER|||||||0.198||||||Unadjusted.|Regression, Linear|||||||0.198
91630738|NCT03277794|183154074|OTHER|||||||0.017||||||Unadjusted.|Regression, Linear|||||||0.017
91630739|NCT03277794|183154075|OTHER|||||||0.091||||||Unadjusted.|Regression, Linear|||||||0.091
91630740|NCT03277794|183154075|OTHER|||||||0.591||||||Unadjusted.|Regression, Linear|||||||0.591
91630741|NCT03277794|183154076|OTHER|||||||0.03||||||Unadjusted.|Regression, Linear|||||||0.030
91630742|NCT03277794|183154076|OTHER|||||||0.005||||||Unadjusted.|Regression, Linear|||||||0.005
91630743|NCT03277794|183154077|OTHER|||||||0.163||||||Unadjusted.|Regression, Linear|||||||0.163
91630744|NCT03277794|183154077|OTHER|||||||0.865||||||Unadjusted.|Regression, Linear|||||||0.865
91630745|NCT03277794|183154078|OTHER|||||||0.98||||||Unadjusted.|Regression, Linear|||||||0.980
91630746|NCT03277794|183154078|OTHER|||||||0.758||||||Unadjusted.|Regression, Linear|||||||0.758
91630747|NCT03277794|183154079|OTHER|||||||0.124||||||Unadjusted.|Regression, Linear|||||||0.124
91630748|NCT03277794|183154079|OTHER|||||||0.168||||||Unadjusted.|Regression, Linear|||||||0.168
91630749|NCT03277794|183154080|OTHER|||||||0.436||||||Unadjusted.|Regression, Linear|||||||0.436
91630750|NCT03277794|183154080|OTHER|||||||0.706||||||Unadjusted.|Regression, Linear|||||||0.706
91630751|NCT03277794|183154081|OTHER|||||||0.604||||||Unadjusted.|Regression, Linear|||Internalizing||||0.604
91630752|NCT03277794|183154081|OTHER|||||||0.177||||||Unadjusted.|Regression, Linear|||Internalizing||||0.177
91630753|NCT03277794|183154081|OTHER|||||||0.325||||||Unadjusted.|Regression, Linear|||Externalizing||||0.325
91630754|NCT03277794|183154081|OTHER|||||||0.227||||||Unadjusted.|Regression, Linear|||Externalizing||||0.227
91630755|NCT03277794|183154081|OTHER|||||||0.106||||||Unadjusted.|Regression, Linear|||Substance Use||||0.106
91630756|NCT03277794|183154081|OTHER|||||||0.058||||||Unadjusted.|Regression, Linear|||Substance Use||||0.058
91630757|NCT03277794|183154082|OTHER|||||||0.862||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.862
91630758|NCT03277794|183154082|OTHER|||||||0.382||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.382
91630759|NCT03277794|183154082|OTHER|||||||0.68||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.680
91630760|NCT03277794|183154082|OTHER|||||||0.988||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.988
91630761|NCT03277794|183154082|OTHER|||||||0.701||||||Unadjusted.|Regression, Linear|||Affectionate||||0.701
91630762|NCT03277794|183154082|OTHER|||||||0.154||||||Unadjusted.|Regression, Linear|||Affectionate||||0.154
91630763|NCT03277794|183154083|OTHER|||||||0.719||||||Unadjusted.|Regression, Linear|||Physical Health||||0.719
91630764|NCT03277794|183154083|OTHER|||||||0.15||||||Unadjusted.|Regression, Linear|||Physical Health||||0.150
91630765|NCT03277794|183154083|OTHER|||||||0.789||||||Unadjusted.|Regression, Linear|||Psychological||||0.789
91630766|NCT03277794|183154083|OTHER|||||||0.811||||||Unadjusted.|Regression, Linear|||Psychological||||0.811
91630767|NCT03277794|183154083|OTHER|||||||0.726||||||Unadjusted.|Regression, Linear|||Social||||0.726
91630768|NCT03277794|183154083|OTHER|||||||0.795||||||Unadjusted.|Regression, Linear|||Social||||0.795
91630769|NCT03277794|183154083|OTHER|||||||0.837||||||Unadjusted.|Regression, Linear|||Environment||||0.837
91630770|NCT03277794|183154083|OTHER|||||||0.048||||||Unadjusted.|Regression, Linear|||Environment||||0.048
91630771|NCT00850135|183154146|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|||||p-Value for the correlation between AUC-110 and birth weight|correlation|||||||0.035
91525680|NCT01316770|182926752|SUPERIORITY|||||||0.662|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.662
91525681|NCT01316770|182926753|SUPERIORITY|||||||0.607|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.607
91525682|NCT01316770|182926754|SUPERIORITY|||||||0.586|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.586
91630772|NCT01512693|183154187|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|0.85|||||TWO_SIDED|90.0|0.61|1.19||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.19|0.61|
91483296|NCT02840240|182840210|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|0.32||||0.09|TWO_SIDED|95.0|0.03|3.16|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic Fairview hospital.||3.16|0.03|0.09
91483297|NCT02840240|182840211|SUPERIORITY||Odds Ratio (OR)|3.5||||0.11|TWO_SIDED|98.75|0.5|24.3|||Regression, Logistic|||||24.3|0.5|0.11
91483298|NCT02840240|182840212|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|98.75|0.2|3.1|||Regression, Logistic|||||3.1|0.2|0.60
91483299|NCT04824365|182840235|SUPERIORITY||Mean Difference (Final Values)|-0.3379|STANDARD_ERROR_OF_MEAN|0.1438||0.0197|TWO_SIDED|95.0|-0.6213|-0.0545|||ANOVA|two-way ANOVA||||-0.0545|-0.6213|0.0197
91483300|NCT04824365|182840236|SUPERIORITY||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.1129||0.736|TWO_SIDED|95.0|-0.1843|0.2605|||ANOVA|Two-way ANOVA||||0.2605|-0.1843|0.736
91665806|NCT01494532|183225228|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.121
91483301|NCT04824365|182840237|SUPERIORITY||Mean Difference (Final Values)|0.3131|STANDARD_ERROR_OF_MEAN|0.1049||0.003|TWO_SIDED|95.0|0.1069|0.5193|||ANOVA|Two-way ANOVA||||0.5193|0.1069|0.0030
91483302|NCT04824365|182840238|SUPERIORITY||Mean Difference (Final Values)|1.704|STANDARD_ERROR_OF_MEAN|0.3035|<|0.0001|TWO_SIDED|95.0|1.105|2.302|||ANOVA|Two-way ANOVA||||2.302|1.105|<0.0001
91525683|NCT01316770|182926768|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.500
91630773|NCT01512693|183154188|SUPERIORITY_OR_OTHER||GMR|0.71|||||TWO_SIDED|90.0|0.51|1.0||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.00|0.51|
91665807|NCT01494532|183225228|SUPERIORITY_OR_OTHER|||||||0.081|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.081
91665808|NCT01494532|183225228|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.187
91483303|NCT04824365|182840239|SUPERIORITY||Mean Difference (Final Values)|1.633|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|0.9672|2.298|||ANOVA|Two-way ANOVA||||2.298|0.9672|<0.0001
91483304|NCT04824365|182840240|SUPERIORITY||Mean Difference (Final Values)|1.964|STANDARD_ERROR_OF_MEAN|0.2473|<|0.0001|TWO_SIDED|95.0|1.477|2.452|||ANOVA|Two-way ANOVA||||2.452|1.477|<0.0001
91483305|NCT04824365|182840241|SUPERIORITY||Mean Difference (Final Values)|-0.4831|STANDARD_ERROR_OF_MEAN|0.2382||0.0435|TWO_SIDED|95.0|-0.9521|-0.01413|||ANOVA|Two-way ANOVA||||-0.01413|-0.9521|0.0435
91483306|NCT04824365|182840242|SUPERIORITY||Mean Difference (Final Values)|-0.05102|STANDARD_ERROR_OF_MEAN|0.2711||0.8509|TWO_SIDED|95.0|-0.5862|0.4841|||ANOVA|Two-way ANOVA||||0.4841|-0.5862|0.8509
91483307|NCT04824365|182840243|SUPERIORITY||Mean Difference (Final Values)|0.1339|STANDARD_ERROR_OF_MEAN|0.3177||0.6738|TWO_SIDED|95.0|-0.4921|0.76|||ANOVA|Two-way ANOVA||||0.7600|-0.4921|0.6738
91483308|NCT04824365|182840244|SUPERIORITY||Mean Difference (Final Values)|0.3095|STANDARD_ERROR_OF_MEAN|0.2832||0.2753|TWO_SIDED|95.0|-0.2478|0.8669|||ANOVA|Two-way ANOVA||||0.8669|-0.2478|0.2753
91483309|NCT04824365|182840245|SUPERIORITY||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.2636|<|0.0001|TWO_SIDED|95.0|-1.948|-0.9043|||ANOVA|Two-way ANOVA||||-0.9043|-1.948|<0.0001
91665809|NCT01494532|183225229|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.134
91665810|NCT01494532|183225229|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.768
91483310|NCT03739840|182840248|SUPERIORITY||Percent reduction|-5.6|||=|0.687|TWO_SIDED|95.0|-38.1|19.2||Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||19.2|-38.1|=0.687
91525684|NCT01316770|182926768|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
91630774|NCT02044367|183154198|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.01|STANDARD_DEVIATION|26.8|||TWO_SIDED|90.0|125.773|149.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.250|125.773|
91630775|NCT02044367|183154198|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|130.43|STANDARD_DEVIATION|27.1|||TWO_SIDED|90.0|119.628|142.2|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||142.200|119.628|
91483311|NCT03739840|182840248|SUPERIORITY||Percent reduction|6.5|||=|0.687|TWO_SIDED|95.0|-22.7|28.7||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.7|-22.7|=0.687
91483312|NCT03739840|182840248|SUPERIORITY||Percent reduction|6.3|||=|0.687|TWO_SIDED|95.0|-22.9|28.6||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.6|-22.9|=0.687
91630776|NCT02044367|183154199|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|146.16|STANDARD_DEVIATION|31.6|||TWO_SIDED|90.0|132.217|161.576|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||161.576|132.217|
91630777|NCT02044367|183154199|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|141.06|STANDARD_DEVIATION|31.5|||TWO_SIDED|90.0|127.644|155.876|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||155.876|127.644|
91630778|NCT02044367|183154200|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.61|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|126.418|149.797|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.797|126.418|
91665811|NCT01494532|183225229|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.859
91665812|NCT01494532|183225229|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.903
91525685|NCT01316770|182926768|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.500
91665813|NCT01494532|183225229|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.470
91665814|NCT01494532|183225230|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
91665815|NCT01494532|183225230|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
91665816|NCT01494532|183225230|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
91665817|NCT01494532|183225230|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
91792289|NCT03947684|183462465|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
91483313|NCT03739840|182840252|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.803|TWO_SIDED|95.0|0.39|3.38||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.38|0.39|=0.803
91483314|NCT03739840|182840252|SUPERIORITY||Odds Ratio (OR)|0.84|||=|0.772|TWO_SIDED|95.0|0.27|2.65||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||2.65|0.27|=0.772
91483315|NCT03739840|182840252|SUPERIORITY||Odds Ratio (OR)|1.01|||=|0.989|TWO_SIDED|95.0|0.33|3.08||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.08|0.33|=0.989
91483316|NCT03739840|182840253|SUPERIORITY||Odds Ratio (OR)|1.4|||=|0.425|TWO_SIDED|95.0|0.61|3.18||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.18|0.61|=0.425
91483317|NCT03739840|182840253|SUPERIORITY||Odds Ratio (OR)|1.23|||=|0.625|TWO_SIDED|95.0|0.53|2.85||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||2.85|0.53|=0.625
91630779|NCT02044367|183154200|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|132.0|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|120.714|144.342|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||144.342|120.714|
91630780|NCT02044367|183154201|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|147.8|STANDARD_DEVIATION|32.4|||TWO_SIDED|90.0|133.384|163.779|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||163.779|133.384|
91630781|NCT02044367|183154201|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|144.8|STANDARD_DEVIATION|32.0|||TWO_SIDED|90.0|130.853|160.242|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||160.242|130.853|
91630782|NCT04157751|183154209|OTHER||Stratified Win Ratio|1.36||||0.0027|TWO_SIDED|95.0|1.09|1.68||p-value for WR\<=1.0 (one-sided), variance calculated using the asymptotic normal U statistics approach.|Asymptotic normal U statistics approach||WR estimate= \[((a)+(c)+(e)+(g)) / ((b)+(d)+(f)+(h))\]|"Stratified win ratio (WR) was used, calculated as total number of wins in the empa group across all strata divided by total number of losses. Weights were applied analogous to a Mantel-Haenszel approach.~1. death in pbo first;~2. death in empa first;~3. HFEs in pbo more frequently;~4. HFEs in empa more frequently;~5. HFEs in pbo first;~6. HFEs in empa first;~7. KCCQ-TSS change lower in pbo;~8. KCCQ-TSS change lower in empa"||1.68|1.09|0.0027
91630783|NCT04157751|183154210|OTHER||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.386||0.097|TWO_SIDED|95.0|0.927|2.501||p-value for OR=1.0 (two-sided).|Regression, Logistic|Wald Confidence interval.|Comparison vs. Placebo.|Logistic regression including terms for baseline KCCQ-TSS, treatment and heart failure status||2.501|0.927|0.0970
91630784|NCT04157751|183154211|OTHER||Difference of adjusted mean|4.45|STANDARD_ERROR_OF_MEAN|2.1||0.0347|TWO_SIDED|95.0|0.32|8.59||p-value for difference = 0 (two-sided)|Mixed Models Analysis|||Restricted maximum likelihood estimation based on a mixed-effect model for repeated measures (MMRM) analysis to obtain adjusted means for the treatment effects. This model included discrete fixed effects for treatment group, and heart failure status at each visit and continuous fixed effects for baseline value at each visit. Missing data caused by patient withdrawal or other reasons were handled implicitly by the MMRM approach. Unstructured covariance structure was used.||8.59|0.32|0.0347
91792290|NCT03947684|183462465|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||>0.05
91483318|NCT03739840|182840253|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.125|TWO_SIDED|95.0|0.84|4.34||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||4.34|0.84|=0.125
91483319|NCT03739840|182840254|SUPERIORITY||Median Difference (Final Values)|3.25|||=|0.737|TWO_SIDED|95.0|-17.08|20.36||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||20.36|-17.08|=0.737
91483320|NCT03739840|182840254|SUPERIORITY||Median Difference (Net)|6.17|||=|0.458|TWO_SIDED|95.0|-10.0|21.91||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||21.91|-10.00|=0.458
91483321|NCT03739840|182840254|SUPERIORITY||Median Difference (Net)|9.31|||=|0.341|TWO_SIDED|95.0|-10.92|28.21||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||28.21|-10.92|=0.341
91489394|NCT02484690|182851575|SUPERIORITY||Difference in Least Squares Means|0.88||||0.9529|TWO_SIDED|80.0|-18.3|20.03||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||20.03|-18.3|0.9529
91525686|NCT01316770|182926768|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
91630785|NCT04157751|183154212|OTHER||Adjusted geometric mean ratio|0.9||||0.0176|TWO_SIDED|95.0|0.82|0.98|||ANCOVA|ANCOVA with a discrete fixed effect for heart failure status and a continuous fixed effect for baseline NT-proBNP level.|Comparison vs. Placebo|Area under the curve (AUC) of change from baseline in log-transformed NT-proBNP level over 30 days of treatment was analysed by an analysis of covariance (ANCOVA). NT-proBNP level is regarded as log-normally distributed, therefore values were log-transformed prior to analysis. The linear trapezoidal rule was used to calculate the AUC after the log-transformation had been applied to each value.||0.98|0.82|0.0176
91630786|NCT04157751|183154215|OTHER||Hazard Ratio (HR)|0.71||||0.1241|TWO_SIDED|95.0|0.46|1.1||p-value for HR=1.0 (two sided)|Regression, Cox|Cox proportional hazard model with terms for heart failure status and treatment.|Comparison vs. Placebo.|||1.10|0.46|0.1241
91630787|NCT00441012|183154298|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|100.0||||||95.0|98.7|100.0|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||100.0|98.7|
91630788|NCT00441012|183154298|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|99.1||||||95.0|69.9|99.9|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||99.9|69.9|
91630789|NCT00441012|183154299|NON_INFERIORITY_OR_EQUIVALENCE|The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs \[GMT modified process vaccine/GMT COMVAX™\] is \>0.67.|Geometric Mean Titer Ratio|2.5||||||95.0|1.9|3.3||||||||3.3|1.9|
91630790|NCT00441012|183154301|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|93.9||||||95.0|90.0|96.6|||||Exact binomial confidence interval|||96.6|90.0|
91630791|NCT00441012|183154301|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|92.1||||||95.0|87.8|95.3|||||Exact binomial confidence interval|No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of participants with anti-PRP \> 1µg/mL) in each group at 1 month after the third dose.||95.3|87.8|
91630792|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.003|TWO_SIDED|95.0|-0.91|-0.19|||t-test, 2 sided|||Corneal staining analysis, day 28.||-0.19|-0.91|0.003
91630793|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.19|TWO_SIDED|95.0|-1.28|0.28|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 18-59 year old subgroup.||0.28|-1.28|0.19
91630794|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.047|TWO_SIDED|95.0|-1.86|-0.02|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 60+ year old subgroup.||-0.02|-1.86|0.047
91630795|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.08|TWO_SIDED|95.0|-1.49|0.1|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, Sjogren's subgroup.||0.10|-1.49|0.08
91630796|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.09|TWO_SIDED|95.0|-1.67|0.14|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.67|0.09
91630797|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.05|-0.3|||t-test, 2 sided|||Conjunctival staining analysis, day 28||-0.30|-1.05|< 0.001
91630798|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.58|TWO_SIDED|95.0|-1.04|0.61|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 18-59 year old subgroup.||0.61|-1.04|0.58
91630799|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.021|TWO_SIDED|95.0|-2.17|-0.21|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 60+ year old subgroup.||-0.21|-2.17|0.021
91665818|NCT01494532|183225230|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
91630800|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.16|TWO_SIDED|95.0|-1.88|0.34|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, Sjogren's subgroup.||0.34|-1.88|0.16
91483322|NCT02788474|182840255|OTHER||Adjusted mean difference|-0.00066|STANDARD_ERROR_OF_MEAN|0.00282||0.8146|TWO_SIDED|95.0|-0.00621|0.00488||random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)|random coefficient regression|The Kenward-Roger approximation was used to estimate denominators degrees of freedom.|Difference calculated as Nintedanib minus Placebo|"The rate of change (slope) in blood CRPM was assumed to be linear in each subject over the 12 weeks of treatment. The intercepts and slopes were assumed to be normally distributed with arbitrary covariance matrix.~Since the distribution of the data was not normal, a log10 transformation was performed before conducting the statistical analyses.~Significance tests were based on least-square means using 2-sided 95% confidence intervals (2-sided α=0.05)."||0.00488|-0.00621|0.8146
91525687|NCT01316770|182926770|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
91525688|NCT01316770|182926770|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
91525689|NCT01316770|182926771|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
91630801|NCT04498468|183154316|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.097|TWO_SIDED|95.0|-1.55|0.14|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.55|0.097
91630802|NCT04498468|183154317|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.069|TWO_SIDED|95.0|-11.4|0.4|||t-test, 2 sided|||Eye dryness, day 28||0.4|-11.4|0.069
91630803|NCT04498468|183154317|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.92|TWO_SIDED|95.0|-7.0|6.3|||t-test, 2 sided|||VAS Eye discomfort, Day 28||6.3|-7.0|0.92
91630804|NCT04498468|183154317|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.55|TWO_SIDED|95.0|-5.8|3.1|||t-test, 2 sided|||VAS eye fatigue, day 28||3.1|-5.8|0.55
91630805|NCT04498468|183154318|SUPERIORITY||Risk Ratio (RR)|1.26||||0.42|TWO_SIDED|95.0|0.8|2.0|||McNemar|||||2.0|0.8|0.42
91630806|NCT04498468|183154319|SUPERIORITY||Risk Ratio (RR)|1.04||||1|TWO_SIDED|95.0|0.76|1.42|||McNemar|||||1.42|0.76|1.00
91630807|NCT00997555|183154323|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||||||0.6
91630808|NCT00997555|183154324|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|t-test, 2 sided|||||||0.7
91630809|NCT00997555|183154325|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).||||||0.4
91630810|NCT00997555|183154326|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||t-test, 2 sided|(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).||||||0.5
91630811|NCT00804986|183154340|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.47||||0.0109|TWO_SIDED|95.0|-0.83|-0.11||p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.11|-0.83|0.0109
91630812|NCT00804986|183154340|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.67||||0.0003|TWO_SIDED|95.0|-1.02|-0.31||p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.31|-1.02|0.0003
91630813|NCT00804986|183154340|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.76||p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.76|-1.46|<0.0001
91630814|NCT00804986|183154340|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.93||p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.93|-1.64|<0.0001
91630815|NCT00804986|183154340|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.88||p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.88|-1.59|<0.0001
91665819|NCT01494532|183225231|SUPERIORITY_OR_OTHER|||||||0.734|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.734
91665820|NCT01494532|183225231|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.048
91665821|NCT01494532|183225231|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.443
91665822|NCT01494532|183225231|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.123
91525690|NCT01316770|182926771|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
91525691|NCT01316770|182926771|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
91525692|NCT01316770|182926771|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
91525693|NCT01316770|182926774|OTHER|||||||0.25|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.250
91525694|NCT01316770|182926774|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
91525695|NCT01316770|182926774|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
91525696|NCT01316770|182926774|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
91525697|NCT01316770|182926775|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
91525698|NCT01316770|182926775|OTHER|||||||0.625|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||0.625
91630816|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|1.93||||0.655||95.0||||p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.655
91630817|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.36||||0.436||95.0||||p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.436
91630818|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.45||||0.914||95.0||||p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.914
91630819|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.3||||0.446||95.0||||p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.446
91630820|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.84||||0.508||95.0||||p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.508
91630821|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.89||||0.561||95.0||||p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.561
91630822|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7.4||||0.135||95.0||||p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.135
91630823|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.45||||0.357||95.0||||p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.357
91483323|NCT02788474|182840256|OTHER||slope estimate|22.001||||0.2084|TWO_SIDED|95.0|-11.83|57.58|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in the Extracellular matrix (ECM) biomarker CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM and the monthly rate of change (slope) in blood CRPM in the first 12 weeks as covariates was applied for placebo-treated patients only to evaluate the potential of CRPM as a prognostic biomarker.||57.58|-11.83|0.2084
91483324|NCT02788474|182840256|OTHER||slope estimate|-45.566||||0.1537|TWO_SIDED|95.0|-109.55|16.37|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess how nintedanib treatment affected the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM, the monthly rate of change (slope) in blood CRPM up to Week 12, treatment and treatment-CRPM slope interaction as covariates was applied.||16.37|-109.55|0.1537
91483325|NCT02788474|182840256|OTHER||Odds Ratio (OR)|0.769||||0.3116|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the overall treatment regimen affected disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM and randomised treatment as covariates was applied.||1.27|0.46|0.3116
91483326|NCT02788474|182840256|OTHER||Odds Ratio (OR)|0.772||||0.3175|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the monthly rate of change (slope) in blood CRPM in the first 12 weeks could explain the effect of treatment on disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM, the rate of change (slope) in blood CRPM in the first 12 weeks and randomised treatment as covariates was applied.||1.27|0.46|0.3175
91483327|NCT02788474|182840257|OTHER||Adjusted mean difference|0.00121|STANDARD_ERROR_OF_MEAN|0.002||0.5469|TWO_SIDED|95.0|-0.00273|0.00515||random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C1M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00515|-0.00273|0.5469
91483328|NCT02788474|182840258|OTHER||Adjusted mean difference|-0.00307|STANDARD_ERROR_OF_MEAN|0.00262||0.2429|TWO_SIDED|95.0|-0.00823|0.00209||random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C3M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00209|-0.00823|0.2429
91483329|NCT02694523|182840270|OTHER||difference in percentage of participants|24.9|||<|0.001|TWO_SIDED|95.0|17.5|32.4|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).||32.4|17.5|<0.001
91483330|NCT02694523|182840271|OTHER||difference in percentage of participants|23.3|||<|0.001|TWO_SIDED|95.0|16.6|30.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||30.1|16.6|<0.001
91483331|NCT02694523|182840272|OTHER||difference in percentage of participants|45.0|||<|0.001|TWO_SIDED|95.0|28.9|61.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||61.1|28.9|<0.001
91483332|NCT02694523|182840273|OTHER||difference in percentage of participants|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||24.9|13.0|<0.001
91483333|NCT02694523|182840274|OTHER||difference in percentage of participants|16.7|||<|0.001|TWO_SIDED|95.0|9.5|23.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||23.9|9.5|<0.001
91483334|NCT02694523|182840275|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
91483335|NCT02694523|182840276|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
91483336|NCT02694523|182840277|OTHER||difference in percentage of participants|38.9|||<|0.001|TWO_SIDED|95.0|22.0|55.8|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||55.8|22.0|<0.001
91483337|NCT01058265|182840290|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in PCS between two groups.||||0.487
91483338|NCT01058265|182840291|SUPERIORITY_OR_OTHER|||||||0.817||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in MCS between two groups.||||0.817
91483339|NCT02169284|182840308|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in benign tissue between erlotinib and placebo||||0.208
91483340|NCT02169284|182840308|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in benign tissue between erlotinib and placebo||||0.208
91483341|NCT02169284|182840308|OTHER|||||||0.272|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in benign tissue between erlotinib and placebo||||0.272
91483342|NCT02169284|182840308|OTHER|||||||0.22|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in benign tissue between erlotinib and placebo||||0.220
91792291|NCT03947684|183462466|OTHER|Repeated measures ANOVA|||||>|0.05|||||||F-test|||Significance was accepted for p values \<0.05.||||>0.05
91630824|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-8.05||||0.105||95.0||||p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.105
91630825|NCT00804986|183154341|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.02||||0.221||95.0||||p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.221
91630826|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.54||||0.4848||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4848
91630827|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-19.48||||0.0029||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0029
91630828|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-32.52|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630829|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-30.45|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630830|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.25|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630831|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5.32||||0.6279||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6279
91630832|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.72||||0.0072||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0072
91630833|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-42.49|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630834|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.05||||0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
91630835|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-51.38|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630836|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-20.21||||0.0335||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0335
91630837|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.91||||0.0221||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0221
91630838|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-39.41|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630839|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-36.07||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
91630840|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.36|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630841|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.41||||0.503||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.5030
91630842|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-12.49||||0.1938||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.1938
91630843|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-33.13||||0.0003||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0003
91630844|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.66||||0.0101||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0101
91630845|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.47|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630846|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.69||||0.006||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0060
91630847|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-34.26||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
91665823|NCT01494532|183225231|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.641
91665824|NCT01494532|183225232|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
91483343|NCT02169284|182840309|OTHER|||||||0.361|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.361
91483344|NCT02169284|182840309|OTHER|||||||0.383|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.383
91483345|NCT02169284|182840309|OTHER|||||||0.427|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.427
91483346|NCT02169284|182840309|OTHER|||||||0.416|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.416
91483347|NCT02169284|182840310|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
91483348|NCT02169284|182840310|OTHER|||||||0.199|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.199
91483349|NCT02169284|182840310|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
91483350|NCT02169284|182840311|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
91483351|NCT02169284|182840311|OTHER|||||||0.288|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.288
91483352|NCT02169284|182840311|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
91483353|NCT02169284|182840312|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||P-value between groups at Baseline||||0.792
91483354|NCT02169284|182840312|OTHER|||||||0.261|||||||Wilcoxon rank-sum test|||P-value between groups at surgery visit||||0.261
91483355|NCT02169284|182840313|OTHER|||||||0.721|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Benign Tissue, P-Value between arms||||0.721
91483356|NCT02169284|182840313|OTHER|||||||0.108|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Tumor Tissue, P-Value between arms||||0.108
91483357|NCT02169284|182840314|OTHER|||||||0.444|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Benign Tissue, P-Value between arms||||0.444
91483358|NCT02169284|182840314|OTHER|||||||0.663|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Tumor Tissue, P-Value between arms||||0.663
91483359|NCT02169284|182840315|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in p-ERK between Normal and Tumor Tissue, P-Value between arms||||1.000
91483360|NCT02169284|182840315|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||Difference in Cytoplasm p-ERK between Normal and Tumor Tissue, P-Value between arms||||0.792
91483361|NCT02169284|182840315|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in Entire Cell p-ERK between Normal and Tumor Tissue, p-value between arms||||1.000
91483362|NCT02169284|182840316|OTHER|||||||0.772|||||||Wilcoxon rank-sum test|||||||0.772
91483363|NCT01367119|182840318|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.171
91483364|NCT01367119|182840319|SUPERIORITY_OR_OTHER|||||||0.258||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.258
91483365|NCT01367119|182840320|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||Comparison between groups for nausea||||0.091
91483366|NCT01367119|182840320|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|||Comparison between groups for headache||||0.763
91483367|NCT01367119|182840320|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||t-test, 2 sided|||Comparison between groups for myalgia||||0.356
91483368|NCT01367119|182840320|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Comparison between groups for visual disturbance||||0.093
91483369|NCT01367119|182840320|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||Comparison between groups for confusion||||0.003
91483370|NCT01367119|182840320|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||Comparison between groups for recovery room agitation||||0.860
91483371|NCT02675231|182840379|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.0506|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.0506
91630848|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.55|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91665825|NCT01494532|183225232|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
91665826|NCT01494532|183225232|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
91665827|NCT01494532|183225232|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
91665828|NCT01494532|183225232|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
91630849|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.34|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630850|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-46.26|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630851|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-11.84||||0.2468||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.2468
91630852|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.13||||0.0413||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects||||||0.0413
91630853|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.19||||0.0004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0004
91630854|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.59||||0.004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0040
91630855|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-49.9|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91483372|NCT02675231|182840379|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.7695|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.7695
91483373|NCT02675231|182840380|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.241|TWO_SIDED|95.0|0.36|1.3|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.30|0.36|0.241
91630856|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.02||||0.0199||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0199
91630857|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.77||||0.0008||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0008
91630858|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.17||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
91630859|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.74||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
91630860|NCT00804986|183154344|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-53.16|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630861|NCT00804986|183154345|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1131.85||||0.4193||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4193
91630862|NCT00804986|183154345|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1471.04||||0.3026||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.3026
91665829|NCT01494532|183225233|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.814
91665830|NCT01494532|183225233|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.013
91630863|NCT00804986|183154345|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5547.95|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630864|NCT00804986|183154345|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6116.19|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91630865|NCT00804986|183154345|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7786.69|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
91792292|NCT03947684|183462467|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data obtained during active pill phase.||||>0.05
91630866|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.08||||0.693||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.693
91630867|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.31||||0.104||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.104
91630868|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.13||||0.506||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.506
91630869|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.648||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.648
91630870|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.647||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.647
91792293|NCT03947684|183462467|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data obtained during inactive pill phase.||||<0.05
91792294|NCT03947684|183462468|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
91792295|NCT03947684|183462468|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||<0.05
91792296|NCT03947684|183462469|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
91792297|NCT03947684|183462469|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||>0.05
91792298|NCT03947684|183462470|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
91792299|NCT03947684|183462470|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||>0.05
91792300|NCT03947684|183462471|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
91792301|NCT03947684|183462471|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||<0.05
91792302|NCT03947684|183462472|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||>0.05
91792303|NCT03947684|183462472|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
91630871|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.781||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.781
91630872|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.401||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.401
91630873|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.03||||0.464||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.464
91665831|NCT01494532|183225233|SUPERIORITY_OR_OTHER|||||||0.287|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.287
91665832|NCT01494532|183225233|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.027
91792304|NCT03947684|183462473|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||>0.05
91792305|NCT03947684|183462473|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||<0.05
91792306|NCT03947684|183462474|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
91792307|NCT03947684|183462474|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||<0.05
91792308|NCT03947684|183462475|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from follicular phase.||||>0.05
91792309|NCT03947684|183462475|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from luteal phase.||||>0.05
91483374|NCT02675231|182840380|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.313|TWO_SIDED|95.0|0.38|1.36|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.36|0.38|0.313
91483375|NCT02675231|182840381|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104|TWO_SIDED|95.0|0.42|1.08|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.08|0.42|0.104
91483376|NCT02675231|182840381|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.10|0.43|0.120
91483377|NCT02675231|182840382|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.049|TWO_SIDED|95.0|0.42|1.0|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.00|0.42|0.049
91483378|NCT02675231|182840382|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.153|TWO_SIDED|95.0|0.48|1.12|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.12|0.48|0.153
91483379|NCT02675231|182840387|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.232|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.232
91483380|NCT02675231|182840388|SUPERIORITY||Least Square (LS) Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.4||0.689|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Global health status||||0.689
91483381|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.3||0.141|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scales: Physical functioning||||0.141
91483382|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.3||0.095|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Role functioning||||0.095
91483383|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.5||0.591|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Emotional functioning||||0.591
91525699|NCT01316770|182926775|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.5000
91630874|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.42||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.420
91630875|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.762||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.762
91665833|NCT01494532|183225233|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.390
91483384|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|2.1||0.935|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Cognitive functioning||||0.935
91483385|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.578|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Social functioning||||0.578
91665834|NCT01494532|183225234|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
91483386|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.8||0.308|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Fatigue||||0.308
91483387|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|2.0||0.043|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Nausea and vomiting||||0.043
91483388|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Pain||||0.026
91483389|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.8||0.276|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Dyspnoea||||0.276
91630876|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.738||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.738
91630877|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.14||||0.277||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.277
91665835|NCT01494532|183225234|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
91665836|NCT01494532|183225234|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
91665837|NCT01494532|183225234|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
91665838|NCT01494532|183225234|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
91665839|NCT01494532|183225235|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
91665840|NCT01494532|183225235|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
91665841|NCT01494532|183225235|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.230
91792310|NCT03947684|183462477|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from follicular phase.||||>0.05
91525700|NCT01316770|182926775|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
91792311|NCT03947684|183462477|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from luteal phase.||||>0.05
91792312|NCT03947684|183462478|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from follicular phase.||||>0.05
91792313|NCT03947684|183462478|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from luteal phase.||||<0.05
91792314|NCT03947684|183462479|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||>0.05
91792315|NCT03947684|183462479|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
91792316|NCT03947684|183462480|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
91792317|NCT03947684|183462480|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
91792318|NCT03947684|183462481|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
91792319|NCT03947684|183462481|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
91792320|NCT03947684|183462482|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
91792321|NCT03947684|183462482|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
91792322|NCT06661954|183462483|OTHER|paired t-tests were used to identify statistically significant differences|||||<|0.05||||||Paired t-tests compared pressure of Bed A and Bed B at each time at each head of bed position (4 tests, two-tailed test, alpha=0.05). A Holm-Bonferroni correction was used to control type 1 error.|t-test, 2 sided|||Peak sacral pressure (mmHg) was collected for every minute of the 10 minute recording. Two averages for each test condition were analyzed (Minutes 1-3 (Min1-3) and 6-8 (Min6-8)). These averages capture pressure during two different 5 minute cycles, when conceivably, sacral pressure would differ. Paired t-tests compared pressure of Bed A and Bed B at each time at each head of bed position (4 tests, two-tailed test, alpha=0.05). A Holm-Bonferroni correction controlled type 1 error.||||<0.05
91665842|NCT01494532|183225235|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
91665843|NCT01494532|183225235|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
91665844|NCT01494532|183225236|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
91665845|NCT01494532|183225236|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
91665846|NCT01494532|183225236|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
91665847|NCT01494532|183225236|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
91665848|NCT01494532|183225236|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
91665849|NCT01494532|183225237|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.007
91665850|NCT01494532|183225237|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.014
91792323|NCT05772702|183462486|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2||||<0.0005
91792324|NCT05772702|183462487|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5||||<0.0005
91630878|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.094||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.094
91792325|NCT05772702|183462489|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91792326|NCT05772702|183462490|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91630879|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.792||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.792
91630880|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.105||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.105
91630881|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.403||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.403
91630882|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.799||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.799
91630883|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.32||||0.029||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.029
91630884|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.439||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.439
91630885|NCT00804986|183154348|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.27||||0.062||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.062
91630886|NCT00804986|183154349|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.16||||0.8003||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.8003
91630887|NCT00804986|183154349|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.26||||0.6736||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6736
91630888|NCT00804986|183154349|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.53||||0.0123||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0123
91630889|NCT00804986|183154349|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.44||||0.4771||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4771
91630890|NCT00804986|183154349|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-2.01||||0.0013||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0013
91630891|NCT01387594|183154381|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.33|||||TWO_SIDED|80.0|1.13|1.56||A p-value was not computed; hypothesis was tested using confidence interval (CI) approach.|||The lower limit of 80% CI greater than 0.5 indicates the statistical significance at alpha=0.1 level.|The null hypothesis is the (median) percent decrease in total lymphocytes count is greater or equal to 50%, equivalently indicating that the geometric mean ratio (GMR: post-treatment/pretreatment) in total lymphocyte counts is less than or equal to 0.5.||1.56|1.13|
91630892|NCT04757376|183154385|EQUIVALENCE|Statistical equivalence: the 90% confidence interval (CI) of the difference in the mean of the primary efficacy endpoint between treatment groups was entirely within an equivalence margin, \[- 1.45, + 1.45\].|Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.76|0.38|||ANCOVA|ANCOVA included the treatment as a fixed effect and age, baseline LS-BMD T-score, and prior bisphosphonates therapy (Yes versus No) as covariates.||||0.38|-0.76|
91630893|NCT01307046|183154399|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-5.1|||<|0.001|TWO_SIDED|95.0|-6.8|-3.4|||constrained longitudinal data analysis|||||-3.4|-6.8|<.001
91630894|NCT01307046|183154400|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-9.2|||<|0.001|TWO_SIDED|95.0|-11.9|-6.5|||constrained longitudinal data analysis|||||-6.5|-11.9|<.001
91630895|NCT00796224|183154463|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|157.98||||||90.0|98.87|252.44|||ANOVA|||Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR)||252.44|98.87|
91630896|NCT00796224|183154465|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|91.63||||||90.0|56.21|149.38|||ANOVA|||||149.38|56.21|
91630897|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|65.44||||||90.0|23.56|181.77|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 1 hour postdose||181.77|23.56|
91630898|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|50.57||||||90.0|25.24|101.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 2 hours postdose||101.30|25.24|
91630899|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|100.07||||||90.0|57.91|172.92|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 3 hours postdose||172.92|57.91|
91630900|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|164.93||||||90.0|103.78|262.12|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 4 hours postdose||262.12|103.78|
91630901|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|174.41||||||90.0|110.07|276.36|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 8 hours postdose||276.36|110.07|
91630902|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|173.01||||||90.0|111.45|268.55|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 24 hours postdose||268.55|111.45|
91630903|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|189.35||||||90.0|129.76|276.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 48 hours postdose||276.30|129.76|
91630904|NCT00796224|183154467|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|183.14||||||90.0|124.61|269.14|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 72 hours postdose||269.14|124.61|
91665851|NCT01494532|183225237|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.016
91630905|NCT04195750|183154503|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00031|TWO_SIDED|95.0|0.63|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.88|0.63|0.00031
91630906|NCT04195750|183154504|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.17644|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.10|0.77|0.17644
91630907|NCT04195750|183154505|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Difference in Percentage|18.4|||<|1e-05|TWO_SIDED|95.0|14.0|23.2||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan minus Everolimus|||23.2|14.0|<0.00001
91630908|NCT04195750|183154509|OTHER||Hazard Ratio (HR)|0.75||||0.0185|TWO_SIDED|95.0|0.58|0.96|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.96|0.58|0.0185
91630909|NCT04195750|183154510|OTHER||Hazard Ratio (HR)|0.93||||0.5533|TWO_SIDED|95.0|0.72|1.2|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.20|0.72|0.5533
91630910|NCT04195750|183154511|OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.69|0.41|<0.0001
91630911|NCT04195750|183154512|OTHER||Difference in Least Squares (LS) Means|6.38|||<|0.0001|TWO_SIDED|95.0|3.21|9.55|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||9.55|3.21|<0.0001
91630912|NCT04195750|183154513|OTHER||Difference in LS Means|2.47||||0.1134|TWO_SIDED|95.0|-0.59|5.54|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||5.54|-0.59|0.1134
91630913|NCT04195750|183154514|OTHER||Difference in LS Means|1.45||||0.0002|TWO_SIDED|95.0|0.7|2.19|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||2.19|0.70|0.0002
91665852|NCT01494532|183225237|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
91665853|NCT01494532|183225237|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
91630914|NCT04195750|183154515|OTHER||Difference in LS Means|3.72||||0.0051|TWO_SIDED|95.0|1.12|6.31|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||6.31|1.12|0.0051
91665854|NCT01494532|183225238|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.047
91665855|NCT01494532|183225238|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
91665856|NCT01494532|183225238|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.172
91665857|NCT01494532|183225238|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.034
91665858|NCT01494532|183225238|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
91665859|NCT01494532|183225239|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.292
91630915|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of vertical bowl transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||<|0.001||||||Comparing the change in performing a vertical bowl transfer, the calculated p-value for this activity was \<.001|t-test, 2 sided|||mRehab task vertical bowl transfer- moving the bowl vertically up and down||||<0.001
91630916|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of moving the bowl horizontally at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.001||||||Comparing the change in performing a horizontal bowl transfer, the calculated p-value for this activity was .001|t-test, 2 sided|||mRehab task horizontal bowl transfer- moving the bowl horizontally||||=.001
91792327|NCT05772702|183462491|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91792328|NCT05772702|183462492|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91630917|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of the vertical mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.003||||||Comparing the change in performing a vertical mug transfer, the calculated p-value for this activity was .003|t-test, 2 sided|||mRehab task vertical mug transfer- moving the mug vertically up and down||||=.003
91630918|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of the horizontal mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.009||||||Comparing the change in performing a horizontal mug transfer, the calculated p-value for this activity was .009|t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.009
91630919|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of the simulated sip at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.933|||||||t-test, 2 sided|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||mRehab task simulate sip- bring mug within one inch of mouth as if taking a drink||||=.933
91630920|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of entering a phone number at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.136|||||||t-test, 2 sided|||mRehab task enter phone number||||=.136
91630921|NCT04363944|183154522|EQUIVALENCE|A paired-t test comparing performance of the quick tap at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.005|||||||t-test, 2 sided|||mRehab task quick tap- tapping a moving object on the phone screen||||=.005
91630922|NCT04363944|183154523|EQUIVALENCE|Paired t-tests comparing performance at the first session of in-home training to the last session of in-home training were conducted.|||||=|0.228|||||||t-test, 2 sided|||mRehab task vertical bowl transfer- moving bowl vertically up and down||||=.228
91630923|NCT04363944|183154523|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||||||0.196|||||||t-test, 2 sided|||mRehab task horizontal bowl- bowl moved horizontally||||.196
91630924|NCT04363944|183154523|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.024|||||||t-test, 2 sided|||mRehab task Vertical Mug- Mug moved vertically and then placed on counter||||=.024
91630925|NCT04363944|183154523|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.038|||||||t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.038
91630926|NCT04363944|183154523|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.306||||||calculated p-value greater than .05|t-test, 2 sided|||mRehab task simulate sip||||=.306
91630927|NCT04363944|183154524|EQUIVALENCE|The average of the WMFT from testing sessions pre intervention (week 1 and approximately week 2) was compared to the WMFT immediately following mRehab home intervention (week 8) using a two tailed paired t-test.|||||=|0.017||||||calculated p-value .017|t-test, 2 sided|||||||=.017
91630928|NCT04363944|183154525|EQUIVALENCE|Test, the scores from the first and second in-laboratory visits were averaged to account for variability in the performance of individuals with stroke. This averaged preintervention score was compared with the third in-laboratory visit to assess the immediate change in performance following use of mRehab.|||||=|0.019|||||||t-test, 2 sided|||Compared pre and post intervention data for participants using mRehab for a 6 week home program.||||=.019
91630929|NCT03559192|183154529|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.25|=|0.0443|ONE_SIDED|80.0||-1.09|||Mixed Models Analysis|||||-1.09||= 0.0443
91792329|NCT05772702|183462492|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|This subscale did not require sphericity corrections.||DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91792330|NCT05772702|183462492|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91630930|NCT03559192|183154530|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.0017|ONE_SIDED|80.0||-2.21|||Mixed Models Analysis|||||-2.21||0.0017
91483390|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.1||0.041|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Insomnia||||0.041
91665860|NCT01494532|183225239|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.068
91665861|NCT01494532|183225239|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.170
91665862|NCT01494532|183225239|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.003
91665863|NCT01494532|183225239|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.153
91665864|NCT01494532|183225240|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.409
91665865|NCT01494532|183225240|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.598
91665866|NCT01494532|183225240|SUPERIORITY_OR_OTHER|||||||0.992|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.992
91665867|NCT01494532|183225240|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.169
91665868|NCT01494532|183225240|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.348
91665869|NCT01404988|183225252|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||For this pilot study, the Type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.1
91665870|NCT01404988|183225252|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2
91665871|NCT01404988|183225253|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||.3
91483391|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|3.4||0.262|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Appetite loss||||0.262
91665872|NCT01404988|183225253|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.77
91665873|NCT01404988|183225254|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.03
91665874|NCT01404988|183225254|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.06
91525701|NCT00909428|182926804|SUPERIORITY||Z-Score|2.803||||0.005|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.||||.005
91525702|NCT00116844|182926806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
91665875|NCT01404988|183225255|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||For this pilot study, type 1 error was set at 5%|Fisher Exact|||||||0.60
91665876|NCT01404988|183225255|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
91665877|NCT04158687|183225402|SUPERIORITY||Least Square (LS) Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.8||0.6003|TWO_SIDED|95.0|-4.5|2.6|||Mixed model repeated measures (MMRM)|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.6|-4.5|0.6003
91665878|NCT04158687|183225402|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.8||0.392|TWO_SIDED|95.0|-2.0|5.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||5.0|-2.0|0.3920
91665879|NCT04158687|183225402|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.8||0.1444|TWO_SIDED|95.0|-0.9|6.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||6.0|-0.9|0.1444
91665880|NCT04158687|183225403|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8065|TWO_SIDED|95.0|-0.3|0.2|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.2|-0.3|0.8065
91665881|NCT04158687|183225403|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2121|TWO_SIDED|95.0|-0.1|0.4|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.4|-0.1|0.2121
91665882|NCT04158687|183225403|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0264|TWO_SIDED|95.0|0.0|0.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.5|0.0|0.0264
91665883|NCT04158687|183225404|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6101|TWO_SIDED|95.0|-2.1|3.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||3.5|-2.1|0.6101
91665884|NCT04158687|183225404|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6237|TWO_SIDED|95.0|-3.4|2.1|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.1|-3.4|0.6237
91665885|NCT04158687|183225404|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.4||0.1764|TWO_SIDED|95.0|-4.6|0.8|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.8|-4.6|0.1764
91665886|NCT02856594|183225405|SUPERIORITY||Odds Ratio (OR)|0.32||||0.029|TWO_SIDED|95.0|0.1|0.83|||Regression, Logistic|||||0.83|0.10|0.029
91665887|NCT02856594|183225407|SUPERIORITY||Odds Ratio (OR)|0.96||||0.24|TWO_SIDED|95.0|0.89|1.03|||Regression, Linear|||||1.03|0.89|0.24
91692019|NCT01139775|183278493|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0946
91692020|NCT03197389|183278500|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|||||||||||||
91714278|NCT00676403|183320240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8784||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8784
91525703|NCT00116844|182926807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
91483392|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.7||0.285|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Constipation||||0.285
91525704|NCT00116844|182926808|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Prescott's method|||||||<0.001
91630931|NCT03559192|183154532|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.87|=|0.4188|ONE_SIDED|80.0||0.41|||Mixed Models Analysis|||||0.41||= 0.4188
91630932|NCT03559192|183154533|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.2503|ONE_SIDED|80.0||0.1|||Mixed Models Analysis|||||0.10||0.2503
91630933|NCT03517722|183154548|SUPERIORITY||Odds Ratio (OR)|0.6||||0.042|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.042
91630934|NCT00089999|183154605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.691|TWO_SIDED|95.0|0.3|1.9|||Fisher Exact|||||1.9|0.3|0.691
91630935|NCT00089999|183154606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.443|TWO_SIDED|95.0|0.3|1.6|||Fisher Exact||Overall Response (i.e. sum of Complete and Partial Responses) comparison|||1.6|0.3|0.443
91630936|NCT03991468|183154613|NON_INFERIORITY|A Mixed Model Repeated Measures logistic regression was used to prove WSI major discordance (MD) rate non-inferior to Glass MD rate. A two-sided 95% CI for the difference in MD rate was constructed. If the upper bound of the 95% CI was less than the non-inferiority margin of 4%, then WSI would be considered non-inferior to Glass, assuming power = 0.9 and alpha = 0.05 a sample size of 2000 was calculated to be sufficient to prove non-inferiority.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|Dependent var = major discordance status (yes/no); independent var = modality (WSI/Glass) as a fixed effect \& site, reader, \& case as random effects.||||1.0|-0.1|
91630937|NCT00616772|183154614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.22|TWO_SIDED|95.0|-0.016|0.004|||Repeated measures linear mixed model|Fixed effects for baseline cIMT, baseline atorvastatin dose, central imaging site, treatment group, time; interaction between treatment group and time||||0.004|-0.016|0.220
91630938|NCT00616772|183154615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.813|TWO_SIDED|95.0|-0.014|0.011|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline cIMT as covariate.||||0.011|-0.014|0.813
91630939|NCT00616772|183154616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.249|TWO_SIDED|95.0|-0.018|0.005|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.005|-0.018|0.249
91630940|NCT00616772|183154617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.487|TWO_SIDED|95.0|-0.02|0.01|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.010|-0.020|0.487
91630941|NCT00616772|183154618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.112|TWO_SIDED|95.0|-0.004|0.035|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.035|-0.004|0.112
91630942|NCT03573804|183154620|OTHER|A two-tailed paired T-test for equivalence was used to evaluate equivalence between the average raw tumor.|Mean Difference (Net)|224.675|STANDARD_ERROR_OF_MEAN|67.89|<|0.001|TWO_SIDED|95.0|90.26044|359.08956||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine tumor intensity values.||Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).||359.08956|90.26044|<0.001
91692021|NCT04129125|183278505|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|83.4|||<|0.0001|TWO_SIDED|95.0|78.0|88.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||88|78|<0.0001
91714279|NCT00676403|183320240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6767||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6767
91792331|NCT05772702|183462492|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91792332|NCT05772702|183462493|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.021|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||0.021
91792333|NCT05772702|183462494|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
91792334|NCT05772702|183462495|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2||||<0.0005
91792335|NCT05772702|183462495|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.006|||||||t-test, 2 sided|||CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2||||0.006
91792336|NCT05710185|183462521|OTHER||||||||||||||||||It was a descriptive study|||
91630943|NCT03573804|183154621|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine mean benign tissue intensities.|Mean Difference (Net)|165.833|STANDARD_ERROR_OF_MEAN|44.19|<|0.001|TWO_SIDED|95.0|78.34708|253.31892||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine normal tissue intensity values.||Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.||253.31892|78.34708|<0.001
91692022|NCT04129125|183278506|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|1.9|||||TWO_SIDED|95.0|0.6|4.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||4.4|0.6|
91792337|NCT04972630|183462537|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0||||||||Baseline control vs. intervention||||
91792338|NCT04972630|183462537|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0||||||||Week 4 control vs. intervention||||
91792339|NCT04972630|183462537|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
91630944|NCT03573804|183154622|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.0058|TWO_SIDED|95.0|-0.04209|0.28209||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.||The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.||0.28209|-0.04209|0.0058
91630945|NCT03573804|183154624|SUPERIORITY|||||||0.00049664|||||||Students two-tailed paired t-test|||||||0.00049664
91630946|NCT03649815|183154625|OTHER|||||||0.067|||||||Paired Sample T-Test|||||||0.067
91630947|NCT03649815|183154625|OTHER|||||||0.071||||||Controlled for gender, age, and baseline symptomatology|Paired Sample T-Test|||||||0.071
91630948|NCT03649815|183154626|OTHER|||||||0.047|||||||Paired Sample T-Test|||||||0.047
91630949|NCT03649815|183154626|OTHER|||||||0.036||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.036
91630950|NCT03649815|183154627|OTHER|||||||0.032|||||||Paired Sample T-Test|||||||0.032
91630951|NCT03649815|183154627|OTHER|||||||0.006||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.006
91630952|NCT01673373|183154644|OTHER|Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.|||||<|0.0001||||||The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.|one-sided exact|||The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.|"The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.~An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%."|||<.0001
91630953|NCT01673373|183154645|OTHER|A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.||||||0.0192||||||The defined threshold for statistical significance is .025.|t-test, 1 sided|||The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.||||.0192
91630954|NCT01654224|183154657|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.005||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.005
91792340|NCT04972630|183462537|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
91792341|NCT04972630|183462538|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
91525705|NCT00116844|182926809|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.800
91630955|NCT01654224|183154657|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.001||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.001
91630956|NCT01654224|183154657|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.004||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.004
91630957|NCT01654224|183154657|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.672||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.672
91630958|NCT01654224|183154657|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.011||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.011
91714280|NCT00676403|183320240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8955||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8955
91630959|NCT01654224|183154657|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.01||||||B/Texas/6/2011|t-test, 2 sided|||||||.010
91630960|NCT01654224|183154658|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.074||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.074
91630961|NCT01654224|183154658|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.006||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.006
91630962|NCT01654224|183154658|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.069||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.069
91630963|NCT01654224|183154658|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.663||||||A/California/07/2009(H3N2)|t-test, 2 sided|||||||.663
91630964|NCT01654224|183154658|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.003||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.003
91630965|NCT01654224|183154658|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.063||||||B/Texas/6/2011|t-test, 2 sided|||||||.063
91630966|NCT01654224|183154659|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.917||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.917
91630967|NCT01654224|183154659|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.36||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.360
91692023|NCT04129125|183278507|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|84.0||||0.0001|TWO_SIDED|95.0|78.0|89.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||89|78|0.0001
91630968|NCT01654224|183154659|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.248||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.248
91630969|NCT01654224|183154659|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.178||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.178
91630970|NCT01654224|183154659|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.152||||||A/Victoria/361/2011(H1N2)|t-test, 2 sided|||||||.152
91630971|NCT01654224|183154659|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.285||||||B/Texas/6/2011|t-test, 2 sided|||||||.285
91630972|NCT00166504|183154665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|15.3|<|0.001||95.0|-14.3|-5.7|||ANOVA||Direction of the Comparison: Vytorin minus Atorvastatin.|||-5.7|-14.3|<0.001
91630973|NCT04423718|183154696|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.97||||0.0009|TWO_SIDED|95.0|-2.87|0.92||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.92|-2.87|0.0009
91630974|NCT04423718|183154696|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-1.14||||0.0011|TWO_SIDED|95.0|-2.97|0.69||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.69|-2.97|0.0011
91630975|NCT04423718|183154697|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.86||||0.0002|TWO_SIDED|95.0|-2.57|0.84||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.84|-2.57|0.0002
91483393|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Diarrhoea||||< 0.001
91483394|NCT02675231|182840388|SUPERIORITY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.0||0.18|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Financial difficulties||||0.180
91525706|NCT00116844|182926810|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.229
91630976|NCT04423718|183154697|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.92|||<|0.0001|TWO_SIDED|95.0|-2.51|0.66||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.66|-2.51|<0.0001
91630977|NCT04423718|183154698|SUPERIORITY|One sided test (alpha = 0.025) for superiority|Difference|11.733||||0.0002|TWO_SIDED|95.0|5.263|18.204||Strictly hierarchical testing procedure to adjust for multiplicity.|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|All HD - 2q8||18.204|5.263|0.0002
91630978|NCT04423718|183154699|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-1.748||||0.5704|TWO_SIDED|95.0|-7.784|4.287||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||4.287|-7.784|0.5704
91630979|NCT04423718|183154699|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.939||||0.7611|TWO_SIDED|95.0|-6.997|5.119||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||5.119|-6.997|0.7611
91630980|NCT04423718|183154700|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.182||||0.9554|TWO_SIDED|95.0|-6.565|6.2||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||6.200|-6.565|0.9554
91630981|NCT04423718|183154700|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-2.221||||0.4834|TWO_SIDED|95.0|-8.435|3.994||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||3.994|-8.435|0.4834
91630982|NCT04423718|183154701|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-1.22||||0.0009|TWO_SIDED|95.0|-1.94|-0.51||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.51|-1.94|0.0009
91630983|NCT04423718|183154701|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.48||||0.2076|TWO_SIDED|95.0|-1.22|0.27||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.27|-1.22|0.2076
91630984|NCT04423718|183154702|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.55||||0.0287|TWO_SIDED|95.0|-1.04|-0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.06|-1.04|0.0287
91630985|NCT04423718|183154702|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.44||||0.087|TWO_SIDED|95.0|-0.94|0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.06|-0.94|0.0870
91692024|NCT04129125|183278508|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|0.9|||||TWO_SIDED|95.0|0.1|3.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||3.4|0.1|
91792342|NCT04972630|183462539|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0||||||||||||
91483395|NCT02675231|182840389|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.033|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.033
91525707|NCT00116844|182926811|SUPERIORITY_OR_OTHER|||||||0.0331||95.0|||||Prescott's method|||||||0.0331
91525708|NCT01933880|182926812|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Signed Rank Sum Test|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||0.0387
91665888|NCT02906917|183225422|NON_INFERIORITY|Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.|Treatment contrast|0.07|||<|0.0001|TWO_SIDED|95.0|-0.06|0.21||One-sided p-value for test of non-inferiority.|ANCOVA|Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.||The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).||0.21|-0.06|<0.0001
91665889|NCT00687739|183225434|SUPERIORITY|The primary analysis compared the GnRHAG + E2 and GnRHAG + PL groups, pooled across exercise status. It was acknowledged that the inclusion of exercisers could minimize the effects of GnRHAG but would be reflective of the effects of ovarian hormone suppression on sedentary and active women. Differences in changes across time between groups were tested using an analysis of covariance model conditioned on baseline.|||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the effect of PL vs E2 collapsed across exercise (2-group comparison). The analysis of effects of exercise was exploratory (evaluated within-group changes only).||||<0.05
91665890|NCT00687739|183225435|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the comparison of within-group changes in the E2 and placebo groups for cortisol AUC in response to Dex/CRH and between-group differences in the changes. Within-group changes and between-group differences in changes were evaluated by linear contrast using an ANCOVA model with adjustment for pre-intervention values of outcomes.||||<0.05
91665891|NCT00687739|183225436|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis compared the GnRHag+E2 and GnRHag+PL groups, pooled across exercise status. Differences in change over time between groups were tested by using an ANCOVA model, first with treatment group alone, and again adding FM and FFM to the model.||||<0.05
91665892|NCT02542462|183225439|SUPERIORITY|||||||0.2||||||P value for the number of subjects with an increase of 1 mm or more of terminal ileum from pre to post was 0.2|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.2
91665893|NCT02542462|183225439|SUPERIORITY|||||||0.3||||||P value for change in the number of subjects with an increase in number of lymph nodes from pre to post was 0.3.|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.3
91665894|NCT02554877|183225450|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.91|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.34|-0.48||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.48|-1.34|<0.0001
91665895|NCT02554877|183225450|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.16|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.59|-0.73||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.73|-1.59|<0.0001
91525709|NCT01933880|182926813|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 1 for the OROS-MPH group||||<0.0001
91525710|NCT01933880|182926814|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 2 for the OROS-MPH group||||0.0001
91665896|NCT02554877|183225450|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.17|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.6|-0.74||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-0.74|-1.60|<0.0001
91792343|NCT04972630|183462540|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0||||||||||||
91525711|NCT01933880|182926815|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 3 for the OROS-MPH group||||<0.0001
91714281|NCT00676403|183320240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9505||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9505
91792344|NCT04972630|183462541|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0||||||||||||
91792345|NCT04972630|183462542|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0||||||||||||
91792346|NCT04972630|183462543|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|3.2|||||TWO_SIDED|95.0||||||||||||
91792347|NCT04972630|183462544|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0||||||||||||
91792348|NCT04972630|183462545|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0||||||||||||
91792349|NCT04972630|183462546|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-6.4|||||TWO_SIDED|95.0||||||||||||
91792350|NCT04972630|183462547|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0||||||||||||
91525712|NCT01933880|182926816|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 7 for the OROS-MPH group||||<0.0001
91525713|NCT01933880|182926817|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||<0.0001
91792351|NCT04972630|183462548|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-16.7|||||TWO_SIDED|95.0||||||||||||
91792352|NCT04972630|183462549|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
91792353|NCT04972630|183462550|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
91792354|NCT04972630|183462550|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
91630986|NCT04423718|183154703|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|11.725||||0.0015|TWO_SIDED|95.0|4.527|18.923||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||18.923|4.527|0.0015
91630987|NCT04423718|183154703|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|7.451||||0.0458|TWO_SIDED|95.0|0.142|14.76||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||14.760|0.142|0.0458
91483396|NCT02675231|182840389|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.275|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.275
91630988|NCT04423718|183154704|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-11.12||||0.0283|TWO_SIDED|95.0|-21.06|-1.18||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-1.18|-21.06|0.0283
91630989|NCT04423718|183154704|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-10.51||||0.0321|TWO_SIDED|95.0|-20.12|-0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||-0.90|-20.12|0.0321
91630990|NCT04423718|183154705|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.72||||0.3817|TWO_SIDED|95.0|-2.35|0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.90|-2.35|0.3817
91630991|NCT04423718|183154705|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.87||||0.307|TWO_SIDED|95.0|-2.55|0.8||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.80|-2.55|0.3070
91630992|NCT03887052|183154728|NON_INFERIORITY|The primary endpoint was performed as a one-sided test with a 0.025 significance level of the null hypothesis (H0) that the WCD false positive shock alarm rate per patient-day for the study device was equal to or greater than the comparator rate (0.29). A random-effects Poisson regression model was fit with the number of false-positive shock alarms for each patient as the outcome, the logarithm of days of wear as an offset, and random site effect.|||||<|0.001||||||"Hypotheses:~H0: p1 ≥ 0.29 H1: p1 \< 0.29~where p1 = A-WCD False Positive Alarm Rate"|One-sided non-inferiority|Poisson Regression Analysis||The analysis was based on the cohort of 130 patients with three false-positive shock alarms occurring over a total of 3501 patient-days (500 weeks), or 0.0060 false-positive shock alarms per patient-week. The Poisson distribution was used to model the results and calculate the false-positive shock alarm rate.||||<0.001
91630993|NCT01266876|183154807|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 200 mg Q4W versus placebo~4. Alirocumab 150 mg Q4W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||0.0000
91630994|NCT01266876|183154807|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0000
91630995|NCT01266876|183154807|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0035
91630996|NCT01266876|183154807|SUPERIORITY_OR_OTHER|||||||0.0113|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0113
91665897|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
91665898|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
91483397|NCT02675231|182840390|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.02||0.546|TWO_SIDED||||||MMRM Model|||||||0.546
91483398|NCT02675231|182840390|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|2.1||0.62|TWO_SIDED||||||MMRM Model|||||||0.620
91630997|NCT01058395|183154826|SUPERIORITY|"Comparison between groups at 3 months (primary).~Comparison between the 2 tiers."||||||0.021||||||P-value|ANCOVA|Threshold for significance was P-value \< 0.05||DRS levels changes at from 4 weeks to 3 months comparing the different doses.||||0.021
91630998|NCT01058395|183154826|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 3 months.||||0.258
91630999|NCT01058395|183154826|SUPERIORITY|t-test||||||0.541|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 4 weeks.||||0.541
91631000|NCT01058395|183154828|SUPERIORITY||Mean Difference (Final Values)|176.0|||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
91631001|NCT02213081|183154860|EQUIVALENCE|Wilcoxon signed rank test was used to determine if the mean difference in pain scores before compared to during ulipristal therapy were equivalent or non-equivalent.|Mean Difference (Net)|3.5|STANDARD_ERROR_OF_MEAN|0.57|<|0.05|TWO_SIDED||||||Wilcoxon signed rank|||||||<0.05
91631002|NCT01836029|183154864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.266|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.266
91631003|NCT01836029|183154866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.399|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.399
91631004|NCT01836029|183154867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536||||||p-values are from Cochran-Mantel-Haenszel tests controlling for randomization stratification factors and comparing tumor response rates between the treatment groups.|Cochran-Mantel-Haenszel|||||||0.536
91631005|NCT01526928|183154879|OTHER||||||||||||||||||Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.|||
91792355|NCT04972630|183462550|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
91483399|NCT02220998|182840394|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.|Difference in proportions|5.2|||||TWO_SIDED|95.0|0.2|10.3|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||10.3|0.2|
91631006|NCT05559203|183154904|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.752|||||||t-test, 2 sided|paired sample||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.752
91483400|NCT02220998|182840394|SUPERIORITY_OR_OTHER|||||||0.018||||||P-value was stratified by cirrhosis status and prior treatment experience.|Cochran-Mantel-Haenszel|||The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of -10%).||||0.018
91631007|NCT05559203|183154905|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.197|||||||t-test, 2 sided|||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.197
91631008|NCT05559203|183154906|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.562|||||||t-test, 2 sided|||||||.562
91631009|NCT05559203|183154907|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.02|||||||t-test, 2 sided|||Anxiety subscale||||.020
91631010|NCT05559203|183154907|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.002|||||||t-test, 2 sided|||Depression subscale||||.002
91665899|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.57|-0.3||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.30|-0.57|<0.0001
91631011|NCT05559203|183154908|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.036|||||||t-test, 2 sided|||||||.036
91631012|NCT05559203|183154909|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.042|||||||t-test, 2 sided|||||||.042
91692025|NCT04129125|183278517|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.7|||||TWO_SIDED|95.0|8.5|16.7|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the all-cause mortality endpoint was for the observed rate to be ≤20.3%||16.7|8.5|
91483401|NCT00873860|182840403|SUPERIORITY_OR_OTHER|||||||0.573||||||Change at Day 92: p-value was based on analysis of variance (ANOVA).|ANOVA|||||||0.573
91483402|NCT00873860|182840403|SUPERIORITY_OR_OTHER|||||||0.64||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.640
91483403|NCT00873860|182840403|SUPERIORITY_OR_OTHER|||||||0.224||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.224
91631013|NCT05559203|183154910|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention|||||<|0.001|||||||t-test, 2 sided|||||||<.001
91631014|NCT05559203|183154911|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.781|||||||t-test, 2 sided|||||||.781
91631015|NCT03489850|183154926|SUPERIORITY||Parameter Estimate|0.34|STANDARD_ERROR_OF_MEAN|0.69||0.62|TWO_SIDED|95.0|-1.01|1.69|||Generalized Estimating Equation|||||1.69|-1.01|.62
91631016|NCT03489850|183154927|SUPERIORITY||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.3|0.98|||Generalized Estimating Equation|||||.98|.30|<0.05
91631017|NCT03489850|183154928|SUPERIORITY||Odds Ratio (OR)|0.83|||<|0.05|TWO_SIDED|95.0|0.47|1.48|||Generalized Estimating Equation|||||1.48|0.47|<0.05
91631018|NCT03489850|183154929|SUPERIORITY||F|7.36|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
91631019|NCT01302691|183154959|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.205|TWO_SIDED|95.0|-2.7|0.6|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||0.6|-2.7|0.205
91792356|NCT04972630|183462550|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
91792357|NCT04972630|183462551|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
91792358|NCT04972630|183462551|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
91792359|NCT04972630|183462551|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
91527814|NCT06173570|182930683|SUPERIORITY||Mean Difference (Net)|-43.86|||<|0.001|TWO_SIDED|95.0|-52.31|-35.41|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-35.41|-52.31|< 0.001
91631020|NCT01302691|183154965|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2||||0.011|TWO_SIDED|95.0|-5.7|-0.8|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||-0.8|-5.7|0.011
91631021|NCT01678560|183155030|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|Exact Fisher test was used on the information from the limited population.||PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|Exact Fisher test was used on the collected information from the limited population.|||<0.01
91631022|NCT01678560|183155031|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||"Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.~Exact Fisher test was used on the collected information from the limited population."|Fisher Exact|Exact Fisher test was used on the information from the limited population||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm|Exact Fisher test was used on the collected information from the limited population|||<0.01
91631023|NCT01678560|183155032|OTHER|Exact Fisher test was used on the collected information from the limited population|Estimation Parameter Other[Fisher exact|1.0|||<|0.01|TWO_SIDED|||||Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.||||<0.01
91631024|NCT01678560|183155033|OTHER|Exact Fisher test was used on the collected information from the limited population|Other[Fisher exact test statistic value]|0.0286|||<|0.01|TWO_SIDED|||||Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population|Fisher Exact||Exact Fisher test was used on the collected information from the limited population.|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population.|||<0.01
91631025|NCT01678560|183155034|OTHER|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test|0.0039|||<|0.01|TWO_SIDED|||||"Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.~Exact Fisher test was used on the collected information from the limited population"|Fisher Exact|Exact Fisher test was used on the collected information from the limited population||Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population|||<0.01
91631026|NCT02725268|183155035|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.178|TWO_SIDED|95.0|0.58|1.12||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.12|0.58|=0.178
91631027|NCT02725268|183155035|SUPERIORITY||Hazard Ratio (HR)|1.85|||=|0.092|TWO_SIDED|95.0|1.19|2.86||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.86|1.19|=0.092
91792360|NCT04972630|183462551|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
91792361|NCT04214288|183462553|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0167||90.0|0.42|0.82|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.82|0.42|0.0167
91792362|NCT04214288|183462553|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.009||90.0|0.46|0.89|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.89|0.46|0.0090
91631028|NCT02725268|183155035|SUPERIORITY||Hazard Ratio (HR)|2.57|||=|0.147|TWO_SIDED|95.0|1.47|4.49||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||4.49|1.47|=0.147
91631029|NCT02725268|183155037|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.968|TWO_SIDED|95.0|0.72|1.5||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.50|0.72|=0.968
91631030|NCT02725268|183155037|SUPERIORITY||Hazard Ratio (HR)|1.5|||=|0.145|TWO_SIDED|95.0|0.95|2.37||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.37|0.95|=0.145
91631031|NCT02725268|183155037|SUPERIORITY||Hazard Ratio (HR)|1.54|||=|0.243|TWO_SIDED|95.0|0.87|2.73||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.73|0.87|=0.243
91631032|NCT02725268|183155038|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.17|TWO_SIDED|95.0|0.57|1.11||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.11|0.57|=0.170
91631033|NCT02725268|183155038|SUPERIORITY||Hazard Ratio (HR)|1.67|||=|0.224|TWO_SIDED|95.0|1.04|2.68||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.68|1.04|=0.224
91631034|NCT02725268|183155038|SUPERIORITY||Hazard Ratio (HR)|2.28|||=|0.244|TWO_SIDED|95.0|1.32|3.96||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||3.96|1.32|=0.244
91631035|NCT02725268|183155039|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.66|2.9|||||The odds ratio and 95% confidence intervals were obtained using a stratified Cochran-Mantel-Haenszel (CMH) model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||2.90|0.66|
91631036|NCT02725268|183155039|SUPERIORITY||Odds Ratio (OR)|0.22|||||TWO_SIDED|95.0|0.04|1.14|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.14|0.04|
91631037|NCT02725268|183155039|SUPERIORITY||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.00|0.00|
91665900|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.42|-0.76|<0.0001
91527815|NCT06173570|182930683|SUPERIORITY||Mean Difference (Net)|-49.8|||<|0.001|TWO_SIDED|95.0|-58.35|-41.25|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-41.25|-58.35|< 0.001
91631038|NCT02725268|183155040|SUPERIORITY||Odds Ratio (OR)|3.02|||||TWO_SIDED|95.0|1.53|5.96|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||5.96|1.53|
91714282|NCT00676403|183320240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0466
91631039|NCT02725268|183155040|SUPERIORITY||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.18|0.86|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.86|0.18|
91631040|NCT02725268|183155040|SUPERIORITY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.15|1.21|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.21|0.15|
91631041|NCT02725268|183155041|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|0.89|7.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||7.67|0.89|
91631042|NCT02725268|183155041|SUPERIORITY||Odds Ratio (OR)|0.15|||||TWO_SIDED|95.0|0.05|0.51|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.51|0.05|
91792363|NCT04214288|183462554|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4828||90.0|0.63|3.31|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.31|0.63|0.4828
91527485|NCT02597933|182930143|OTHER||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.54||0.0331|TWO_SIDED|1.15|0.09|2.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC \[% pred\], \& including treatment-by-time and baseline-by-time interactions. Random effect was included for patient specific intercept \& time.~Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-Components variance-covariance matrix."||2.21|0.09|0.0331
91631043|NCT02725268|183155041|SUPERIORITY||Odds Ratio (OR)|0.07|||||TWO_SIDED|95.0|0.01|0.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.67|0.01|
91631044|NCT01838304|183155044|OTHER||Odds Ratio (OR)|7.9|||<|0.0001|TWO_SIDED|95.0|4.21|14.81|||Fisher Exact|||Fisher's exact test for odd's ratio of time below a saturation of 80% to total time||14.81|4.21|<0.0001
91792364|NCT04214288|183462554|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3691||90.0|0.69|3.67|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.67|0.69|0.3691
91792365|NCT04214288|183462558|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2554|TWO_SIDED|90.0|0.84|2.64|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.64|0.84|0.2554
91792366|NCT04214288|183462558|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1658||90.0|0.91|2.89|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.89|0.91|0.1658
91792367|NCT02278341|183462568|NON_INFERIORITY|Non Inferiority, Margin = -0.75|LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.132|0.339||p-value for non-inferiority test based on 1-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb and baseline Hb by visit as continuous variable.||0.339|0.132|<0.001
91792368|NCT02278341|183462569|NON_INFERIORITY|Non-Inferiority, Margin = -0.75|LSM Difference|0.171|||<|0.001|TWO_SIDED|95.0|0.082|0.261||p-value for non-inferiority test based on 1-sided significance level.|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable. Statistical analysis used was ANCOVA model with multiple imputations (MI). Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model.||0.261|0.082|<0.001
91792369|NCT02278341|183462570|NON_INFERIORITY|Non-inferiority of roxadustat versus ESA (the non-inferiority margin for the difference between groups is -15%).|Difference of Percentages|2.3|||<|0.05|TWO_SIDED|95.0|-2.9|7.6||p-value for non-inferiority test based on 1-sided significance level.|Miettinen and Nurminen|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||7.6|-2.9|<0.05
91792370|NCT02278341|183462571|SUPERIORITY||LSM Difference|-0.377|||<|0.001|TWO_SIDED|95.0|-0.451|-0.304||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline LDL, baseline Hb as continuous variables.||-0.304|-0.451|<0.001
91792371|NCT02278341|183462572|SUPERIORITY||LSM Difference|-31.9|||<|0.001|TWO_SIDED|95.0|-41.4|-22.4||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-22.4|-41.4|<0.001
91792372|NCT02278341|183462573|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.205|||<|0.05|TWO_SIDED|95.0|-0.649|1.059||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 PF, baseline Hb as continuous variables.||1.059|-0.649|<0.05
91792373|NCT02278341|183462574|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.856|||<|0.05|TWO_SIDED|95.0|-0.115|1.828|||Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 VT, baseline Hb as continuous variables.||1.828|-0.115|<0.05
91631045|NCT03674541|183155046|SUPERIORITY|||||||0.043|||||||Welch's t-test|||||||0.043
91631046|NCT03674541|183155047|SUPERIORITY|||||||0.008||||||P-value was not adjusted for multiplicity for secondary outcomes|Welch's t-test|||||||0.008
91631047|NCT03674541|183155048|SUPERIORITY|||||||0.263||||||Not adjusted for multiplicity|Welch's t-test|||||||0.263
91631048|NCT03674541|183155049|SUPERIORITY|||||||0.039||||||Not adjusted for multiplicity|Welch's t-test|||||||0.039
91631049|NCT03674541|183155050|SUPERIORITY|||||||0.068||||||Not adjusted for multiplicity|Welch's t-test|||||||0.068
91631050|NCT03674541|183155051|SUPERIORITY|||||||0.045||||||Not adjusted for multiplicity|Welch's t-test|||||||0.045
91631051|NCT03674541|183155052|SUPERIORITY|||||||1||||||Not adjusted multiplicity|Welch's t-test|||||||1.000
91631052|NCT03674541|183155053|SUPERIORITY|||||||0.093||||||Not adjusted for multiplicity|Welch's t-test|||||||0.093
91792374|NCT02278341|183462575|NON_INFERIORITY|The margin for non-inferiority was 1.|LSM Difference|-0.849|||<|0.05|TWO_SIDED|95.0|-1.971|0.273||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.273|-1.971|<0.05
91792375|NCT02278341|183462576|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3).|Hazard Ratio (HR)|0.924|||<|0.05|TWO_SIDED|95.0|0.669|1.276||p-value for non-inferiority test based on 1-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Non-inferiority was declared if the upper bound of the 95% CI is below 1.3.||1.276|0.669|<0.05
91527486|NCT02597933|182930144|OTHER||Mean Difference (Final Values)|46.41|STANDARD_ERROR_OF_MEAN|19.51||0.0177|TWO_SIDED|95.0|8.09|84.73|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||84.73|8.09|0.0177
91631053|NCT03674541|183155054|SUPERIORITY|||||||0.427||||||Not adjusted for multiplicity|Welch's t-test|||||||0.427
91631054|NCT03674541|183155055|SUPERIORITY|||||||0.262||||||Not adjusted for multiplicity|Welch's t-test|||||||0.262
91631055|NCT03674541|183155056|SUPERIORITY|||||||0.038||||||Not adjusted for multiplicity|Welch's t-test|||||||0.038
91631056|NCT03674541|183155057|SUPERIORITY|||||||0.147|||||||Welch's t-test|||||||0.147
91631057|NCT00117572|183155078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.68|TWO_SIDED|95.0|0.59|1.41|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|Comparison of overall survival curves||1.41|0.59|0.68
91631058|NCT00117572|183155079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.55|1.25|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.25|0.55|0.37
91792376|NCT02278341|183462577|SUPERIORITY||LSM Difference|-0.579|||=|0.308|TWO_SIDED|95.0|-1.694|0.536||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.536|-1.694|=0.308
91792377|NCT02278341|183462578|SUPERIORITY||Hazard Ratio (HR)|0.915|||=|0.582|TWO_SIDED|95.0|0.668|1.254||p-value for superiority test based on 2-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.254|0.668|=0.582
91792378|NCT02278341|183462579|SUPERIORITY||Difference of Percentages|1.4|||=|0.609|TWO_SIDED|95.0|-3.8|6.5||p-value for superiority test based on 2-sided significance level|Miettinen and Nurminen method|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||6.5|-3.8|=0.609
91792379|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.164|||<|0.001|TWO_SIDED|95.0|0.072|0.256||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.256|0.072|<0.001
91631059|NCT00117572|183155080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.16|TWO_SIDED|95.0|0.51|1.12|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.12|0.51|0.16
91631060|NCT00117572|183155081|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
91631061|NCT00117572|183155082|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
91631062|NCT00117572|183155083|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|Comparison of change scores between treatment groups||||||0.55
91631063|NCT00117572|183155084|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||||||0.034
91631064|NCT00117572|183155085|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
91665901|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.8|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.80|<0.0001
91631065|NCT00117572|183155086|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
91631066|NCT00117572|183155087|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
91631067|NCT00117572|183155088|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
91631068|NCT00117572|183155089|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
91631069|NCT00117572|183155090|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.090
91631070|NCT04973085|183155096|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91631071|NCT00654368|183155104|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the one-sided 95% confidence interval (CI), defined below, exceeded the noninferiority margin of -0.6, then noninferiority was to be concluded.|Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.75|-0.06|||||The 95% CI was calculated using the mean square error from an analysis of variance (ANOVA) fitted with effects for treatment and covariates of duration of disease, type of reimbursement, and 6 month DAS28.|||-0.06|-0.75|
91631072|NCT00815776|183155117|NON_INFERIORITY_OR_EQUIVALENCE|The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.|||||<|0.0096|||||||student's t-test with 2n-2 DoF|||The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(\< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.||||<0.0096
91714283|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3876
91631073|NCT00815776|183155118|NON_INFERIORITY_OR_EQUIVALENCE|Safety analyses were performed on the ITT population.||||||0.688|||||||t-test, 1 sided|||Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.||||0.688
91631074|NCT00815776|183155119|SUPERIORITY_OR_OTHER|||||||0.2995||||||From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.|t-test, 2 sided|||A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.||||.2995
91665902|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.79|<0.0001
91665903|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.93|-0.49||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 8.||-0.49|-0.93|<0.0001
91665904|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.96|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.17|-0.74||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.74|-1.17|<0.0001
91665905|NCT02554877|183225451|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.76||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.76|-1.20|<0.0001
91665906|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-37.83|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-47.96|-27.7||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-27.70|-47.96|<0.0001
91665907|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-44.85|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-54.98|-34.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-34.72|-54.98|<0.0001
91483404|NCT00873860|182840404|SUPERIORITY_OR_OTHER|||||||0.4686||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.4686
91527487|NCT02597933|182930145|OTHER||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|8.39||0.4547|TWO_SIDED|95.0|-22.77|10.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||10.21|-22.77|0.4547
91665908|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-48.59|STANDARD_ERROR_OF_MEAN|5.18|<|0.0001|TWO_SIDED|95.0|-58.81|-38.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-38.37|-58.81|<0.0001
91665909|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-30.63|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-42.52|-18.74||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-18.74|-42.52|<0.0001
91665910|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-39.24|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-51.13|-27.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-27.35|-51.13|<0.0001
91665911|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-38.3|STANDARD_ERROR_OF_MEAN|6.04|<|0.0001|TWO_SIDED|95.0|-50.22|-26.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-26.38|-50.22|<0.0001
91692026|NCT04129125|183278528|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.3|||||TWO_SIDED|95.0|8.1|17.2|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤20.3%||17.2|8.1|
91631075|NCT04228445|183155120|SUPERIORITY||Odds Ratio (OR)|14.041|||<|0.0001|TWO_SIDED|95.0|7.394|26.662|||Score statistics for Type 3 GEE analysis|||||26.662|7.394|<0.0001
91631076|NCT04228445|183155120|SUPERIORITY||Odds Ratio (OR)|16.772|||<|0.0001|TWO_SIDED|95.0|8.625|32.617|||Score statistics for Type 3 GEE analysis|||||32.617|8.625|<0.0001
91631077|NCT04228445|183155121|OTHER||Percentage of Responders|87.8|||||TWO_SIDED|95.0|78.6|96.9|||||Missing data imputed as non-responder|||96.9|78.6|
91631078|NCT04228445|183155121|OTHER||Percentage of Responders|87.2|||||TWO_SIDED|95.0|77.7|96.8|||||Missing data imputed as non-responder|||96.8|77.7|
91631079|NCT04228445|183155122|OTHER||percentage of satisfaction|89.8|||||TWO_SIDED|95.0|78.2|95.6||||||||95.6|78.2|
91631080|NCT04228445|183155122|OTHER||percentage of satisfaction|80.9|||||TWO_SIDED|95.0|67.5|89.6||||||||89.6|67.5|
91631081|NCT04228445|183155123|OTHER||median time to visualization (minutes)|6.0|||||TWO_SIDED|95.0|5.25|7.0||||||||7.00|5.25|
91631082|NCT04228445|183155123|OTHER||median time to visualization (minutes)|5.93|||||TWO_SIDED|95.0|5.12|7.0||||||||7.00|5.12|
91631083|NCT04228445|183155124|SUPERIORITY||Odds Ratio (OR)|19.532|||<|0.0001|TWO_SIDED|95.0|8.738|43.663|||Score statistics for Type 3 GEE analysis|||||43.663|8.738|<0.0001
91631084|NCT04228445|183155124|SUPERIORITY||Odds Ratio (OR)|15.73|||<|0.0001|TWO_SIDED|95.0|7.199|34.369|||Score statistics for Type 3 GEE analysis|||||34.369|7.199|<0.0001
91792380|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.443|||<|0.001|TWO_SIDED|95.0|0.339|0.546||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.546|0.339|<0.001
91631085|NCT04228445|183155125|OTHER||Percentage of Agreement|91.1|||||TWO_SIDED|||||||||Left Ureter||||
91631086|NCT04228445|183155125|OTHER||Percentage of Agreement|88.4|||||TWO_SIDED|||||||||Left Ureter||||
91631087|NCT04228445|183155125|OTHER||Percentage of Agreement|76.1|||||TWO_SIDED|||||||||Left Ureter||||
91631088|NCT04228445|183155125|OTHER||Percentage of Agreement|95.6|||||TWO_SIDED|||||||||Right Ureter||||
91631089|NCT04228445|183155125|OTHER||Percentage of Agreement|86.0|||||TWO_SIDED|||||||||Right Ureter||||
91631090|NCT04228445|183155125|OTHER||Percentage of Agreement|71.6|||||TWO_SIDED|||||||||Right Ureter||||
91631091|NCT04228445|183155126|SUPERIORITY||Odds Ratio (OR)|0.771||||0.4595|TWO_SIDED|95.0|0.388|1.534|||Score statistics for Type 3 GEE analysis|||||1.534|.388|0.4595
91631092|NCT04228445|183155127|SUPERIORITY||Odds Ratio (OR)|1.036||||0.922|TWO_SIDED|95.0|0.509|2.11|||Score statistics for Type 3 GEE analysis|||||2.110|.509|0.9220
91631093|NCT03028467|183155142|OTHER||Mean Difference (Net)|-1.111|||||TWO_SIDED|95.0|-2.7186|0.4965|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.4965|-2.7186|
91631094|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.5177|||||TWO_SIDED|95.0|-1.904|0.8685|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8685|-1.9040|
91631095|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.5332|||||TWO_SIDED|95.0|-1.914|0.8475|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8475|-1.9140|
91631096|NCT03028467|183155142|OTHER||Mean Difference (Net)|-1.1387|||||TWO_SIDED|95.0|-2.8848|0.6075|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6075|-2.8848|
91631097|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.8905|||||TWO_SIDED|95.0|-2.3962|0.6153|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6153|-2.3962|
91631098|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.8047|||||TWO_SIDED|95.0|-2.3045|0.6951|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6951|-2.3045|
91631099|NCT03028467|183155142|OTHER||Mean Difference (Net)|-1.4575|||||TWO_SIDED|95.0|-3.6013|0.6863|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6863|-3.6013|
91631100|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.8894|||||TWO_SIDED|95.0|-2.7381|0.9593|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.9593|-2.7381|
91631101|NCT03028467|183155142|OTHER||Mean Difference (Net)|-1.1615|||||TWO_SIDED|95.0|-3.0028|0.6799|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6799|-3.0028|
91631102|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.3209|||||TWO_SIDED|95.0|-2.3021|1.6603|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.6603|-2.3021|
91631103|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.1876|||||TWO_SIDED|95.0|-1.896|1.5209|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5209|-1.8960|
91631104|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.4593|||||TWO_SIDED|95.0|-2.161|1.2424|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.2424|-2.1610|
91631105|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.6521|||||TWO_SIDED|95.0|-3.1342|1.83|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.8300|-3.1342|
91483405|NCT00873860|182840404|SUPERIORITY_OR_OTHER|||||||0.317||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3170
91483406|NCT00873860|182840404|SUPERIORITY_OR_OTHER|||||||0.1664||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.1664
91483407|NCT00873860|182840404|SUPERIORITY_OR_OTHER|||||||0.3234||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3234
91631106|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.5499|||||TWO_SIDED|95.0|-2.6903|1.5904|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5904|-2.6903|
91631107|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.9665|||||TWO_SIDED|95.0|-3.0984|1.1654|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1654|-3.0984|
91631108|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.3576|||||TWO_SIDED|95.0|-3.0892|2.374|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.3740|-3.0892|
91631109|NCT03028467|183155142|OTHER||Mean Difference (Net)|0.1851|||||TWO_SIDED|95.0|-2.1704|2.5407|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.5407|-2.1704|
91631110|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.1181|||||TWO_SIDED|95.0|-2.4643|2.2281|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.2281|-2.4643|
91631111|NCT03028467|183155142|OTHER||Mean Difference (Net)|-1.4276|||||TWO_SIDED|95.0|-3.6569|0.8018|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8018|-3.6569|
91631112|NCT03028467|183155142|OTHER||Mean Difference (Net)|0.5415|||||TWO_SIDED|95.0|-1.381|2.4639|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.4639|-1.3810|
91483408|NCT00873860|182840404|SUPERIORITY_OR_OTHER|||||||0.3133||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3133
91631113|NCT03028467|183155142|OTHER||Mean Difference (Net)|-0.7932|||||TWO_SIDED|95.0|-2.708|1.1217|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1217|-2.7080|
91631114|NCT00460525|183155149|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.17||||0.175||95.0|-0.09|0.37||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|No adjustments were made.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first clinical malaria episode with significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.09|0.175
91631115|NCT00460525|183155151|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.2||||0.068||95.0|-0.02|0.37||The a priori threshold for statistical significance was set at 0.05.|Poisson regression|No adjustments|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.|Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.02|0.068
91631116|NCT02550093|183155161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||HEAT||||.47
91631117|NCT02550093|183155161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.70
91714284|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7959||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7959
91714285|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2032
91714286|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7032
91714287|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0551||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0551
91714288|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.4100
91714289|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6524||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6524
91792381|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.561|||<|0.001|TWO_SIDED|95.0|0.451|0.672||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 3 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.672|0.451|<0.001
91792382|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.708|||<|0.001||95.0|0.588|0.828||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 4 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.828|0.588|<0.001
91792383|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.768|||<|0.001|TWO_SIDED|95.0|0.645|0.89||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 5 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.890|0.645|<0.001
91792384|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.604|0.855||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 6 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.855|0.604|<0.001
91792385|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.603|0.856||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 7 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.856|0.603|<0.001
91792386|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.574|0.826||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 8 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.826|0.574|<0.001
91792387|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.659|||<|0.001|TWO_SIDED|95.0|0.53|0.788||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 10 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.788|0.530|<0.001
91631118|NCT02550093|183155162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.84
91631119|NCT02550093|183155162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.95
91631120|NCT02550093|183155163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.92
91631121|NCT02550093|183155163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.63
91631122|NCT02550093|183155164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91631123|NCT02550093|183155165|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91631124|NCT02550093|183155166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
91631125|NCT02550093|183155167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91631126|NCT02550093|183155168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91631127|NCT02550093|183155169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
91631128|NCT02550093|183155170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
91631129|NCT02550093|183155171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91631130|NCT02550093|183155172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
91631131|NCT02200510|183155204|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.33||||0.575|TWO_SIDED||||||ANOVA|||||||0.575
91631132|NCT02200510|183155204|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.138||||0.721|TWO_SIDED||||||ANOVA|||||||0.721
91631133|NCT03057106|183155205|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.46|TWO_SIDED|90.0|0.67|1.16||2-sided, adjusted for stratification factors at rtandomization.|Log Rank|||||1.16|0.67|0.46
91631134|NCT03057106|183155206|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0035|TWO_SIDED|95.0|0.52|0.88||2-sided, adjusted for stratification factors at randomization.|Log Rank|Adjusted for stratification factors at randomization.||||0.88|0.52|0.0035
91631135|NCT03057106|183155207|SUPERIORITY||Odds Ratio (OR)|1.69||||0.033|TWO_SIDED|95.0|1.04|2.76||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel|||||2.76|1.04|0.033
91631136|NCT01874353|183155238|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.22|<0.0001
91631137|NCT01874353|183155238|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.17|1.19||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.19|0.17|
91631138|NCT01874353|183155239|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0537|TWO_SIDED|95.0|0.54|1.0||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \<1 favours olaparib|||1.00|0.54|0.0537
91631139|NCT01874353|183155239|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.38|2.49||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||2.49|0.38|
91631140|NCT01874353|183155240|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
91631141|NCT01874353|183155240|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.18|1.03||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||1.03|0.18|
91631142|NCT01874353|183155241|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.34|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.34|0.0002
91631143|NCT01874353|183155241|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.22|3.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes treatment factor only|A hazard ratio \< 1 favours olaparib|||3.97|0.22|
91792388|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.593|||<|0.001|TWO_SIDED|95.0|0.459|0.727||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 12 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.727|0.459|<0.001
91792389|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.503|||<|0.001|TWO_SIDED|95.0|0.366|0.64||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 14 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.640|0.366|<0.001
91631144|NCT01874353|183155242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03||||0.9765|TWO_SIDED|95.0|-2.191|2.126|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||2.126|-2.191|0.9765
91631145|NCT01874353|183155243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.48||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.48|0.28|<0.0001
91631146|NCT01874353|183155243|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.21|1.08||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.08|0.21|
91665912|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.47|STANDARD_ERROR_OF_MEAN|6.29||0.0023|TWO_SIDED|95.0|-31.88|-7.05||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-7.05|-31.88|0.0023
91792390|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.369|||<|0.001|TWO_SIDED|95.0|0.229|0.51||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 16 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.510|0.229|<0.001
91792391|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.363|||<|0.001|TWO_SIDED|95.0|0.23|0.496||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 18 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.496|0.230|<0.001
91527488|NCT02597933|182930146|OTHER||Hazard Ratio (HR)|1.16||||0.7535|TWO_SIDED|95.0|0.47|2.84|||Regression, Cox|Based on Cox's regression model (Wald test), stratified by ATA status.||||2.84|0.47|0.7535
91631147|NCT01874353|183155244|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.68||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.68|0.39|<0.0001
91631148|NCT01874353|183155244|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.85||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model included treatment factor only|A hazard ratio \< 1 favours olaparib|||1.85|0.37|
91692027|NCT00204490|183278556|OTHER|||||||0.071|||||||t-test, 2 sided|||(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.071
91692028|NCT00204490|183278556|OTHER|||||||0.08|||||||t-test, 2 sided|||(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.080
91483409|NCT00873860|182840404|SUPERIORITY_OR_OTHER|||||||0.2108||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.2108
91483410|NCT00873860|182840411|SUPERIORITY_OR_OTHER|||||||0.934||||||ACQ score \<=0.75, Day 92: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.934
91483411|NCT00873860|182840411|SUPERIORITY_OR_OTHER|||||||0.592||||||ACQ score \<=0.75, Day 169: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.592
91631149|NCT01874353|183155245|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.49||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.49|0.28|<0.0001
91631150|NCT01874353|183155245|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.2|1.04||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours the Olaparib arm|||1.04|0.20|
91631151|NCT01874353|183155246|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
91631152|NCT03728881|183155249|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.5|||||TWO_SIDED|96.0|0.44|0.57|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.57|0.44|
91631153|NCT03728881|183155251|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|Ratio of the GMCs|1.11|||||TWO_SIDED|96.0|0.95|1.29|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.95|
91631154|NCT03728881|183155253|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.36|0.5|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.50|0.36|
91665913|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.98|STANDARD_ERROR_OF_MEAN|6.23|<|0.0001|TWO_SIDED|95.0|-49.27|-24.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-24.69|-49.27|<0.0001
91665914|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.14|STANDARD_ERROR_OF_MEAN|6.29|<|0.0001|TWO_SIDED|95.0|-47.55|-22.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-22.72|-47.55|<0.0001
91692029|NCT00204490|183278556|OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.045||0.019|TWO_SIDED||||||Regression, Linear|Mixed model|slope for interaction of treatment and time, placebo was the reference group; square root transformed outcome.|Intention to treat||||0.019
91792392|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.284|||<|0.001|TWO_SIDED|95.0|0.154|0.414||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 20 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.414|0.154|<0.001
91483412|NCT00873860|182840416|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
91665915|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.77|STANDARD_ERROR_OF_MEAN|6.1||0.0014|TWO_SIDED|95.0|-31.81|-7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-7.73|-31.81|0.0014
91665916|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.26|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-47.17|-23.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-23.35|-47.17|<0.0001
91665917|NCT02554877|183225452|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.44|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001|TWO_SIDED|95.0|-48.43|-24.46||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-24.46|-48.43|<0.0001
91483413|NCT00873860|182840416|SUPERIORITY_OR_OTHER|||||||0.6022||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||0.6022
91483414|NCT00873860|182840416|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
91483415|NCT00873860|182840416|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
91483416|NCT00873860|182840416|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
91483417|NCT00873860|182840416|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
91483418|NCT00873860|182840417|SUPERIORITY_OR_OTHER|||||||0.551||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.551
91483419|NCT00873860|182840417|SUPERIORITY_OR_OTHER|||||||0.492||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.492
91665918|NCT02554877|183225453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.057||||0.0059|TWO_SIDED|95.0|1.68|21.82||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||21.82|1.68|0.0059
91665919|NCT02554877|183225453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.927||||0.0008|TWO_SIDED|95.0|2.49|31.96||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||31.96|2.49|0.0008
91483420|NCT00873860|182840417|SUPERIORITY_OR_OTHER|||||||0.983||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.983
91483421|NCT00873860|182840417|SUPERIORITY_OR_OTHER|||||||0.991||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.991
91483422|NCT00873860|182840417|SUPERIORITY_OR_OTHER|||||||0.9||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.900
91483423|NCT00873860|182840417|SUPERIORITY_OR_OTHER|||||||0.673||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.673
91483424|NCT00873860|182840418|SUPERIORITY_OR_OTHER|||||||0.546||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.546
91483425|NCT00873860|182840418|SUPERIORITY_OR_OTHER|||||||0.534||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.534
91483426|NCT00873860|182840418|SUPERIORITY_OR_OTHER|||||||0.847||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.847
91483427|NCT00873860|182840418|SUPERIORITY_OR_OTHER|||||||0.987||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.987
91483428|NCT00873860|182840418|SUPERIORITY_OR_OTHER|||||||0.992||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.992
91483429|NCT00873860|182840418|SUPERIORITY_OR_OTHER|||||||0.688||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.688
91665920|NCT02554877|183225453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.116|||<|0.0001|TWO_SIDED|95.0|4.34|52.67||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||52.67|4.34|<0.0001
91692030|NCT03477006|183278560|SUPERIORITY|||||||0.91|||||||Chi-squared|||||||0.91
91483430|NCT00591266|182840474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.19|||<|0.001|TWO_SIDED|95.0|-13.29|-9.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.09|-13.29|<0.001
91483431|NCT00591266|182840474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91|||<|0.001|TWO_SIDED|95.0|-13.0|-8.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.81|-13.00|<0.001
91483432|NCT00591266|182840475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-13.93|-8.1||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.10|-13.93|<0.001
91692031|NCT03477006|183278561|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
91483433|NCT00591266|182840475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|||<|0.001|TWO_SIDED|95.0|-12.48|-6.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-6.63|-12.48|<0.001
91483434|NCT00591266|182840476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.48|||<|0.001|TWO_SIDED|95.0|-8.84|-6.11||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.11|-8.84|<0.001
91483435|NCT00591266|182840476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.65|||<|0.001|TWO_SIDED|95.0|-9.01|-6.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-9.01|<0.001
91483436|NCT00591266|182840477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.93|||<|0.001|TWO_SIDED|95.0|-6.62|-3.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.23|-6.62|<0.001
91483437|NCT00591266|182840477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.58|||<|0.001|TWO_SIDED|95.0|-7.28|-3.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.88|-7.28|<0.001
91483438|NCT00591266|182840478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.64|||<|0.001|TWO_SIDED|95.0|-13.86|-9.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.41|-13.86|<0.001
91483439|NCT00591266|182840478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.17|||<|0.001|TWO_SIDED|95.0|-13.39|-8.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.95|-13.39|<0.001
91483440|NCT00591266|182840479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-9.47|-6.5||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.50|-9.47|<0.001
91483441|NCT00591266|182840479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.04|||<|0.001|TWO_SIDED|95.0|-9.52|-6.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.55|-9.52|<0.001
91665921|NCT02554877|183225453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.1532|TWO_SIDED|95.0|0.64|17.47||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||17.47|0.64|0.1532
91483442|NCT00591266|182840480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.001|TWO_SIDED|95.0|-12.07|-7.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.34|-12.07|<0.001
91483443|NCT00591266|182840480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|||<|0.001|TWO_SIDED|95.0|-12.03|-7.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.31|-12.03|<0.001
91483444|NCT00591266|182840481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26|||<|0.001|TWO_SIDED|95.0|-7.94|-4.57||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.57|-7.94|<0.001
91483445|NCT00591266|182840481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28|||<|0.001|TWO_SIDED|95.0|-7.96|-4.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.60|-7.96|<0.001
91483446|NCT00591266|182840482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.27|||<|0.001|TWO_SIDED|95.0|-14.63|-9.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.92|-14.63|<0.001
91483447|NCT00591266|182840482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||<|0.001|TWO_SIDED|95.0|-13.93|-9.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.23|-13.93|<0.001
91483448|NCT00591266|182840483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.39|||<|0.001|TWO_SIDED|95.0|-9.98|-6.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-9.98|<0.001
91483449|NCT00591266|182840483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.001|TWO_SIDED|95.0|-9.82|-6.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-9.82|<0.001
91483450|NCT00591266|182840484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||<|0.001|TWO_SIDED|95.0|-11.45|-6.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-11.45|<0.001
91483451|NCT00591266|182840484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.001|TWO_SIDED|95.0|-11.51|-6.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.30|-11.51|<0.001
91483452|NCT00591266|182840485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|||<|0.001|TWO_SIDED|95.0|-7.88|-4.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.00|-7.88|<0.001
91483453|NCT00591266|182840485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-8.47|-4.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.61|-8.47|<0.001
91483454|NCT00591266|182840486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.15|5.26||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.26|2.15|<0.001
91792393|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.197|||=|0.003|TWO_SIDED|95.0|0.065|0.329||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 22 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.329|0.065|=0.003
91631155|NCT03728881|183155255|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.9|||||TWO_SIDED|99.0|0.75|1.08|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.08|0.75|
91631156|NCT03728881|183155256|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
91631157|NCT03728881|183155257|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.006|||||||Fisher Exact|||||||=0.006
91631158|NCT03728881|183155258|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
91631159|NCT03728881|183155259|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.48|||||||Fisher Exact|||||||=0.48
91631160|NCT03728881|183155265|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.42|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.56|0.42|
91631161|NCT03728881|183155266|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.||||||1|||||||Fisher Exact|||||||1.0
91631162|NCT03728881|183155268|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.09|||||TWO_SIDED|96.0|0.93|1.27||||||||1.27|0.93|
91631163|NCT03728881|183155269|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.0006|||||||Fisher Exact|||||||=0.0006
91631164|NCT03728881|183155271|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.35|0.49|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.49|0.35|
91631165|NCT03728881|183155272|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
91631166|NCT03728881|183155274|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.86|||||TWO_SIDED|99.0|0.71|1.04|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.04|0.71|
91792394|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.187|||=|0.004|TWO_SIDED|95.0|0.059|0.316||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 24 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.316|0.059|=0.004
91792395|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.243|||<|0.001|TWO_SIDED|95.0|0.113|0.373||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 26 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.373|0.113|<0.001
91792396|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.207|||=|0.002|TWO_SIDED|95.0|0.074|0.34||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 28 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.340|0.074|=0.002
91483455|NCT00591266|182840486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.05|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|2.05|<0.001
91631167|NCT03728881|183155275|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.478|||||||Fisher Exact|||||||=0.478
91792397|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.227|||<|0.001|TWO_SIDED|95.0|0.096|0.358||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 30 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.358|0.096|<0.001
91631168|NCT03728881|183155277|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.58|1.12|
91631169|NCT03728881|183155280|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.29|||||TWO_SIDED|95.0|1.09|1.54|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.54|1.09|
91631170|NCT03728881|183155283|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.81|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.81|1.20|
91631171|NCT03728881|183155284|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
91631172|NCT03728881|183155286|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.15|1.75|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.75|1.15|
91631173|NCT03728881|183155287|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|0.368|||||||Fisher Exact|||||||=0.368
91631174|NCT03728881|183155289|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.46|||||TWO_SIDED|96.0|0.38|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.56|0.38|
91631175|NCT03728881|183155289|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.58|||||TWO_SIDED|96.0|0.48|0.7|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.70|0.48|
91631176|NCT03728881|183155289|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.079||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.079
91631177|NCT03728881|183155290|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 36 months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.0000
91665922|NCT02554877|183225453|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.198||||0.0826|TWO_SIDED|95.0|0.83|21.22||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||21.22|0.83|0.0826
91692032|NCT03477006|183278562|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
91792398|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.199|||=|0.004|TWO_SIDED|95.0|0.064|0.334|||Mixed Models Analysis|p-value for superiority test based on 2-sided significance level.||Week 32 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.334|0.064|=0.004
91792399|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.279|||<|0.001||95.0|0.15|0.409||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 34 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.409|0.150|<0.001
91792400|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.256|||<|0.001|TWO_SIDED|95.0|0.121|0.391||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.391|0.121|<0.001
91792401|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.136|||=|0.06|TWO_SIDED|95.0|-0.006|0.277||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 40 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.277|-0.006|=0.060
91792402|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.082|||=|0.293|TWO_SIDED|95.0|-0.071|0.236||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 44 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.236|-0.071|=0.293
91792403|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.027|||=|0.723|TWO_SIDED|95.0|-0.123|0.177||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 48 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.177|-0.123|=0.723
91792404|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.199|||=|0.009|TWO_SIDED|95.0|0.049|0.348||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 52 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.348|0.049|=0.009
91631178|NCT03728881|183155292|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01|||||TWO_SIDED|96.0|0.82|1.25||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.25|0.82|
91631179|NCT03728881|183155292|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.24|||||TWO_SIDED|96.0|1.01|1.54||||||The cohort for the analysis of HPV16 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11.||1.54|1.01|
91631180|NCT03728881|183155292|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.14||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.14
91631181|NCT03728881|183155293|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the younger one-dose recipients and the younger three-dose recipients.|||||=|0.001||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between younger one-dose recipients (9-11 Year Old Girls) and the younger three-dose recipients (18-21 Year Old Women).||||=0.001
91631182|NCT03728881|183155293|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.737||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between older one-dose recipients (12-14 Year Old Girls) and the older three-dose recipients (22-25 Year Old Women).||||=0.737
91631183|NCT03728881|183155295|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.33|0.52||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.52|0.33|
91631184|NCT03728881|183155295|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.47|||||TWO_SIDED|99.0|0.37|0.6||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.60|0.37|
91792405|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.147|||=|0.056|TWO_SIDED|95.0|-0.004|0.298||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 56 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.298|-0.004|=0.056
91792406|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.196|||=|0.01|TWO_SIDED|95.0|0.047|0.346||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 60 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.346|0.047|=0.010
91792407|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.275|||<|0.001|TWO_SIDED|95.0|0.123|0.427||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 64 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.427|0.123|<0.001
91483456|NCT00591266|182840487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.001|TWO_SIDED|95.0|2.08|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.08|<0.001
91792408|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.206|||=|0.006|TWO_SIDED|95.0|0.059|0.353||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 68 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.353|0.059|=0.006
91527816|NCT06173570|182930684|SUPERIORITY||Mean Difference (Net)|-21.22|||<|0.001|TWO_SIDED|95.0|-26.27|-16.18|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-16.18|-26.27|< 0.001
91631185|NCT03728881|183155295|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.028||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.028
91631186|NCT03728881|183155296|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 24months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.000
91631187|NCT03728881|183155298|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.85|||||TWO_SIDED|99.0|0.65|1.1||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.10|0.65|
91631188|NCT03728881|183155298|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.0|||||TWO_SIDED|99.0|0.77|1.29||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.77|
91631189|NCT03728881|183155298|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.24||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.24
91631190|NCT03728881|183155299|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between younger one-dose and younger three-dose recipients.|||||=|0.216||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between younger one-dose recipients (9-12 Year Old Girls) and younger three-dose recipients (18-21 Year Old Women).||||=0.216
91631191|NCT03728881|183155299|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between older one-dose recipients (12-14 Year Old Girls) and older three-dose recipients (22-25 Year Old Women).||||=1.000
91631192|NCT03728881|183155301|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52|||||TWO_SIDED|96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
91665923|NCT02554877|183225453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.588||||0.0272|TWO_SIDED|95.0|1.21|25.73||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||25.73|1.21|0.0272
91665924|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.03|STANDARD_ERROR_OF_MEAN|3.4||0.7618|TWO_SIDED|90.0|-6.66|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.59|-6.66|0.7618
91792409|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.118|||=|0.127|TWO_SIDED|95.0|-0.033|0.269||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 72 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.269|-0.033|=0.127
91714290|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3219||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3219
91792410|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.211|||=|0.01|TWO_SIDED|95.0|0.051|0.371||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 76 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.371|0.051|=0.010
91631193|NCT03728881|183155301|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.41|0.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.58|0.41|
91631194|NCT03728881|183155301|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.73||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.73
91631195|NCT03728881|183155302|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate one-dose and three-dose recipients who enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
91631196|NCT03728881|183155304|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.26||||||96.0|1.0|1.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.58|1.00|
91631197|NCT03728881|183155304|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01||||||96.0|0.83|1.24||||||||1.24|0.83|
91631198|NCT03728881|183155304|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.15||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.15
91792411|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.102|||=|0.191|TWO_SIDED|95.0|-0.051|0.255||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 80 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.255|-0.051|=0.191
91792412|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.192|||=|0.018|TWO_SIDED|95.0|0.033|0.351||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 84 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.351|0.033|=0.018
91483457|NCT00591266|182840487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.25|6.75||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.75|2.25|<0.001
91483458|NCT00591266|182840488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.71|4.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.02|1.71|<0.001
91631199|NCT03728881|183155305|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.253||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.253
91714291|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3509||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3509
91792413|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.044|||=|0.576|TWO_SIDED|95.0|-0.111|0.2||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 88 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.200|-0.111|=0.576
91483459|NCT00591266|182840488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.001|TWO_SIDED|95.0|2.01|4.82||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.82|2.01|<0.001
91483460|NCT01074047|182840542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0829|TWO_SIDED|95.0|0.69|1.02|||Log Rank|The p-value is two-sided from an unstratified log-rank test|The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.02|0.69|0.0829
91792414|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.203|||=|0.017|TWO_SIDED|95.0|0.037|0.369||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 92 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.369|0.037|=0.017
91483461|NCT01074047|182840542|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1009|TWO_SIDED|95.0|0.69|1.03|||Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.03|0.69|0.1009
91483462|NCT01074047|182840543|SUPERIORITY_OR_OTHER||Difference|12.26|||||TWO_SIDED|95.0|3.5|21.0|||||Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|||21.0|3.5|
91527489|NCT02597933|182930147|OTHER||Odds Ratio (OR)|1.03||||0.9115|TWO_SIDED|95.0|0.57|1.88|||Cochran-Mantel-Haenszel|||The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.|Missing values were imputed using worst case, i.e. considered having disease progression.|1.88|0.57|0.9115
91631200|NCT03728881|183155305|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.015||||||A p-value under 0.05 will be regarded as significant|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.015
91631201|NCT03728881|183155307|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.43||||||99.0|0.33|0.55||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.55|0.33|
91631202|NCT03728881|183155307|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.34|0.52||||||||0.52|0.34|
91631203|NCT03728881|183155307|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.95||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.95
91631204|NCT03728881|183155308|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
91631205|NCT03728881|183155310|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.91|||||TWO_SIDED|99.0|0.69|1.19||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.19|0.69|
91792415|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.184|||=|0.019|TWO_SIDED|95.0|0.031|0.338||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 96 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.338|0.031|=0.019
91483463|NCT01074047|182840544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1495|TWO_SIDED|95.0|0.72|1.05|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of EFS||1.05|0.72|0.1495
91483464|NCT01074047|182840545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5832|TWO_SIDED|95.0|0.75|1.66|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of RFS||1.66|0.75|0.5832
91483465|NCT01074047|182840546|SUPERIORITY_OR_OTHER|||||||0.5384|||||||Fisher Exact|P-value is from Fishers exact test||||||0.5384
91483466|NCT01074047|182840548|SUPERIORITY_OR_OTHER|||||||0.0376|||||||Fisher Exact|P-value is from Fishers exact test||||||0.0376
91483467|NCT01074047|182840572|SUPERIORITY_OR_OTHER||Relative Ratio|0.79||||0.0721|TWO_SIDED|95.0|0.62|1.02|||negative binomial regression analysis|||||1.02|0.62|0.0721
91483468|NCT01711372|182840596|OTHER||||||||||||||Chi-squared|||AUC or ROC for Groundskeeper Game|AUC of ROC is 0.78|||
91483469|NCT01711372|182840597|OTHER||||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76|||
91525714|NCT00069784|182926850|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.022||||0.6273|TWO_SIDED|95.0|0.937|1.114||For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.||1.114|0.937|0.6273
91525715|NCT00069784|182926851|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.038||||0.2692|TWO_SIDED|95.0|0.972|1.109||The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|See above additional details provided for the analysis of the first coprimary outcome.||1.109|0.972|0.2692
91525716|NCT00069784|182926852|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983|||||TWO_SIDED|95.0|0.899|1.076|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.076|0.899|
91525717|NCT00069784|182926853|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97|||||TWO_SIDED|95.0|0.9|1.047|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.047|0.900|
91792416|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.164|||=|0.056||95.0|-0.004|0.333||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 100 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.333|-0.004|=0.056
91792417|NCT02278341|183462580|SUPERIORITY||LSM Difference|0.099|||=|0.267|TWO_SIDED|95.0|-0.076|0.273||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 104 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.273|-0.076|=0.267
91792418|NCT02278341|183462581|SUPERIORITY||LSM Difference|0.237|||<|0.001|TWO_SIDED|95.0|0.127|0.347||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.347|0.127|<0.001
91483470|NCT01711372|182840598|OTHER|AUC of ROC|||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62|||
91483471|NCT00674973|182840612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1909|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).||1.10|0.63|0.1909
91483472|NCT00763048|182840622|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
91525718|NCT00069784|182926854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).|||0.91|0.58|
91631206|NCT03728881|183155310|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.89|||||TWO_SIDED|99.0|0.69|1.14||||||||1.14|0.69|
91483473|NCT00763048|182840623|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
91525719|NCT04466215|182926857|SUPERIORITY||Slope|-0.063|STANDARD_ERROR_OF_MEAN|0.04||0.065|TWO_SIDED|||||One-tail test of directional hypothesis.|Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictor was drug plasma concentration. Arms were combined for this analysis.||||.065
91631207|NCT03728881|183155310|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.88||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.88
91631208|NCT03728881|183155311|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.629||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.629
91631209|NCT03728881|183155311|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.175||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.175
91665925|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.65|STANDARD_ERROR_OF_MEAN|3.39||0.8489|TWO_SIDED|90.0|-6.25|4.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.96|-6.25|0.8489
91483474|NCT00763048|182840624|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
91483475|NCT00763048|182840625|SUPERIORITY_OR_OTHER|||||||0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91483476|NCT00763048|182840626|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91631210|NCT03728881|183155313|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52||||||96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
91631211|NCT03728881|183155313|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.48||||||96.0|0.4|0.58||||||||0.58|0.40|
91631212|NCT03728881|183155313|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.46||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.46
91631213|NCT03728881|183155314|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
91631214|NCT03728881|183155316|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.27||||||96.0|1.03|1.57||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.57|1.03|
91631215|NCT03728881|183155316|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.99||||||96.0|0.8|1.23||||||||1.23|0.80|
91631216|NCT03728881|183155316|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.095||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.095
91631217|NCT03728881|183155317|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|0.327||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=0.327
91631218|NCT03728881|183155317|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.012||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.012
91631219|NCT03728881|183155319|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.45|||||TWO_SIDED|99.0|0.36|0.58||||||||0.58|0.36|
91631220|NCT03728881|183155319|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.4|||||TWO_SIDED|99.0|0.32|0.5||||||||0.50|0.32|
91714292|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0053||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0053
91483477|NCT00763048|182840627|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91483478|NCT00763048|182840628|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91483479|NCT00763048|182840629|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91665926|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.47|STANDARD_ERROR_OF_MEAN|3.42||0.4699|TWO_SIDED|90.0|-3.17|8.12||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.12|-3.17|0.4699
91665927|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.22|STANDARD_ERROR_OF_MEAN|3.27||0.4979|TWO_SIDED|90.0|-7.63|3.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.19|-7.63|0.4979
91665928|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-3.45|STANDARD_ERROR_OF_MEAN|3.27||0.2927|TWO_SIDED|90.0|-8.85|1.95||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.95|-8.85|0.2927
91665929|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.83|STANDARD_ERROR_OF_MEAN|3.28||0.143|TWO_SIDED|90.0|-10.26|0.6||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||0.60|-10.26|0.1430
91665930|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.25|STANDARD_ERROR_OF_MEAN|3.73||0.7373|TWO_SIDED|90.0|-7.42|4.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.92|-7.42|0.7373
91665931|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.46|STANDARD_ERROR_OF_MEAN|3.7||0.5075|TWO_SIDED|90.0|-8.57|3.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.66|-8.57|0.5075
91665932|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.81|STANDARD_ERROR_OF_MEAN|3.74||0.6295|TWO_SIDED|90.0|-7.99|4.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.37|-7.99|0.6295
91792419|NCT02278341|183462581|SUPERIORITY||LSM Difference|0.105|||=|0.086|TWO_SIDED|95.0|-0.015|0.225||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.225|-0.015|=0.086
91483480|NCT00763048|182840630|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91665933|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.15|STANDARD_ERROR_OF_MEAN|3.95||0.4266|TWO_SIDED|90.0|-3.39|9.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.69|-3.39|0.4266
91665934|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.96|STANDARD_ERROR_OF_MEAN|3.89||0.2038|TWO_SIDED|90.0|-1.47|11.4||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.40|-1.47|0.2038
91665935|NCT02554877|183225458|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.29|STANDARD_ERROR_OF_MEAN|3.92||0.5592|TWO_SIDED|90.0|-4.19|8.78||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.78|-4.19|0.5592
91665936|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.09|||||TWO_SIDED|90.0|-5.86|16.05||||||Placebo was the reference and each of the active doses was the test for Week 2.||16.05|-5.86|
91483481|NCT00518687|182840651|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|18.5||||0.584|TWO_SIDED|95.0|-48.6|55.8||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significantly greater than 20%|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||55.8|-48.6|0.584
91665937|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.86|||||TWO_SIDED|90.0|-9.76|15.48||||||Placebo was the reference and each of the active doses was the test for Week 2.||15.48|-9.76|
91665938|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.13|||||TWO_SIDED|90.0|3.91|30.34||||||Placebo was the reference and each of the active doses was the test for Week 2.||30.34|3.91|
91665939|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.71|||||TWO_SIDED|90.0|-10.8|16.22||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.22|-10.80|
91665940|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.92|||||TWO_SIDED|90.0|-10.61|16.45||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.45|-10.61|
91483482|NCT00518687|182840652|SUPERIORITY_OR_OTHER||Estimated rate difference|0.0||||0.997|TWO_SIDED|95.0|-0.1|0.1|||Miettinen and Nurminen|||||0.1|-0.1|0.997
91665941|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.57|||||TWO_SIDED|90.0|-15.08|9.94||||||Placebo was the reference and each of the active doses was the test for Week 4.||9.94|-15.08|
91483483|NCT00518687|182840653|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|12.9||||0.347|TWO_SIDED|95.0|-50.8|50.0||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||50.0|-50.8|0.347
91483484|NCT00518687|182840654|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|29.3||||0.032|TWO_SIDED|95.0|-1.8|51.2||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||51.2|-1.8|0.032
91483485|NCT01442038|182840656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948||||0.48|TWO_SIDED|95.0|0.818|1.099||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.099|0.818|0.48
91631221|NCT03728881|183155319|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.3||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.30
91631222|NCT03728881|183155320|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
91631223|NCT03728881|183155322|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.02||||||99.0|0.79|1.32||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.32|0.79|
91631224|NCT03728881|183155322|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.81||||||99.0|0.63|1.04||||||||1.04|0.63|
91631225|NCT03728881|183155322|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.1||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.10
91631226|NCT03728881|183155323|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
91631227|NCT03728881|183155323|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.339||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.339
91631228|NCT05505734|183155334|SUPERIORITY||Hazard Ratio (HR)|0.535|||<|0.001|TWO_SIDED|95.0|0.392|0.73||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.730|0.392|<0.001
91631229|NCT05505734|183155335|SUPERIORITY||Hazard Ratio (HR)|0.539|||<|0.001|TWO_SIDED|95.0|0.397|0.733||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.733|0.397|<0.001
91631230|NCT05505734|183155336|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.405|0.724||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.724|0.405|<0.001
91665942|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.63|||||TWO_SIDED|90.0|-16.29|13.03||||||Placebo was the reference and each of the active doses was the test for Week 8.||13.03|-16.29|
91665943|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.59|||||TWO_SIDED|90.0|-20.4|11.22||||||Placebo was the reference and each of the active doses was the test for Week 8.||11.22|-20.40|
91483486|NCT01442038|182840657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.4|TWO_SIDED|95.0|0.244|1.691||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.691|0.244|0.40
91483487|NCT01442038|182840658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.82|TWO_SIDED|95.0|0.579|1.994||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.994|0.579|0.82
91631231|NCT05505734|183155337|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.406|0.72||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.720|0.406|<0.001
91631232|NCT05505734|183155338|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.34|0.64||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.64|0.34|<0.001
91631233|NCT05505734|183155339|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.63||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.63|0.33|<0.001
91631234|NCT05505734|183155340|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
91631235|NCT05505734|183155341|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
91631236|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|2.777|||TWO_SIDED|95.0|-3.39|7.91|||||Day 1, Max HR|||7.91|-3.39|
91631237|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|95.0|-4.78|7.28|||||Day 7, Max HR|||7.28|-4.78|
91631238|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-2.37|8.91|||||Day 1, Max HR|||8.91|-2.37|
91483488|NCT01442038|182840659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.968||||0.81|TWO_SIDED|95.0|0.745|1.256||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.256|0.745|0.81
91631239|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|2.729|||TWO_SIDED|95.0|-7.89|3.39|||||Day 7, Max HR|||3.39|-7.89|
91631240|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|2.899|||TWO_SIDED|95.0|1.59|13.39|||||Day 1, Max HR|||13.39|1.59|
91631241|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|3.079|||TWO_SIDED|95.0|2.34|15.05|||||Day 7, Max HR|||15.05|2.34|
91631242|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.243|||TWO_SIDED|95.0|-4.8|4.34|||||Day 1, WM|||4.34|-4.80|
91631243|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.52|||TWO_SIDED|95.0|-5.09|5.4|||||Day 7, WM|||5.40|-5.09|
91483489|NCT02611960|182840672|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2262|TWO_SIDED|95.0|0.67|1.19||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.19|0.67|0.2262
91631244|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|2.182|||TWO_SIDED|95.0|-2.12|6.77|||||Day 1, WM|||6.77|-2.12|
91483490|NCT02611960|182840673|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.9419|TWO_SIDED|95.0|0.94|1.75||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.75|0.94|0.9419
91631245|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|2.378|||TWO_SIDED|95.0|-7.48|2.45|||||Day 7, WM|||2.45|-7.48|
91631246|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|2.282|||TWO_SIDED|95.0|1.51|10.81|||||Day 1, WM|||10.81|1.51|
91631247|NCT00732472|183155347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|STANDARD_ERROR_OF_MEAN|2.642|||TWO_SIDED|95.0|1.57|12.54|||||Day 7, WM|||12.54|1.57|
91631248|NCT02623699|183155420|SUPERIORITY||least square (LS) mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.22|=|0.9689|TWO_SIDED|95.0|-3.19|5.53||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank||ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the Analysis of covariance (ANCOVA) for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||5.53|-3.19|= 0.9689
91665944|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.75|||||TWO_SIDED|90.0|-13.66|19.16||||||Placebo was the reference and each of the active doses was the test for Week 8.||19.16|-13.66|
91665945|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.86|||||TWO_SIDED|90.0|-3.3|19.02||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.02|-3.30|
91631249|NCT02623699|183155421|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|< 0.0001
91631250|NCT02623699|183155421|SUPERIORITY||Difference in LS geometric mean ratio|0.75|||=|0.0002|TWO_SIDED|95.0|0.6|0.95|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.95|0.60|=0.0002
91631251|NCT02623699|183155421|SUPERIORITY||Difference in LS geometric mean ratio|0.81|||=|0.0641|TWO_SIDED|95.0|0.65|1.02|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||1.02|0.65|=0.0641
91631252|NCT02623699|183155421|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|<0.0001
91631253|NCT02623699|183155422|SUPERIORITY||Difference in LS geometric mean ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78||The analysis was based on ANCOVA model with natural log transformed data. P-value for this secondary outcome measure (OM) is nominal as statistical significance was not met on the primary OM.|ANCOVA|||The ANCOVA model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone. Multiple imputation was used to handle missing data for withdrawals. Difference in LS geometric mean ratio to baseline (BIIB067:Placebo) was calculated.||0.78|0.49|< 0.0001
91631254|NCT02623699|183155423|SUPERIORITY||Difference in LS geometric mean ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.25|0.45||The analysis was based on ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.45|0.25|< 0.0001
91631255|NCT02623699|183155424|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|5.829|=|0.3233|TWO_SIDED|95.0|-3.528|19.322||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.|ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the ANCOVA for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||19.322|-3.528|= 0.3233
91631256|NCT02623699|183155425|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.118|=|0.839|TWO_SIDED|95.0|-0.207|0.255||ANCOVA model included treatment as fixed effect and adjusts for following covariates: Baseline disease duration since symptom onset, baseline HHD overall megascore, and use of riluzole/edaravone. Missing data were handled using multiple imputation.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||||0.255|-0.207|= 0.8390
91631257|NCT01426009|183155429|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0723|STANDARD_ERROR_OF_MEAN|0.0188||0.0003|TWO_SIDED|95.0|0.0347|0.1099|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence. A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1099|0.0347|0.0003
91483491|NCT02611960|182840674|SUPERIORITY||Difference in Percentage|-1.9||||0.63479|TWO_SIDED|95.0|-12.7|8.9||One-sided p-value for testing. H0: difference in percentage = 0 versus H1: difference in percentage \> 0.|Stratified Miettinen and Nurminen Method|||Comparison based on Miettinen \& Nurminen method stratified by presence of liver metastasis.||8.9|-12.7|0.63479
91665946|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.13|||||TWO_SIDED|90.0|-16.13|13.87||||||Placebo was the reference and each of the active doses was the test for Week 12.||13.87|-16.13|
91665947|NCT02554877|183225459|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.99|||||TWO_SIDED|90.0|-7.07|19.04||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.04|-7.07|
91665948|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.04|STANDARD_ERROR_OF_MEAN|2.52||0.68|TWO_SIDED|90.0|-3.12|5.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.20|-3.12|0.6800
91665949|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.515|TWO_SIDED|90.0|-2.52|5.8||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.80|-2.52|0.5150
91665950|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.66|STANDARD_ERROR_OF_MEAN|2.53||0.0676|TWO_SIDED|90.0|0.47|8.85||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.85|0.47|0.0676
91665951|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|2.48||0.8021|TWO_SIDED|90.0|-4.73|3.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.48|-4.73|0.8021
91483492|NCT00137631|182840682|SUPERIORITY_OR_OTHER||Rate Ratio|0.58|||<|0.05||95.0|0.33|1.01|||negative binomial regression|||||1.01|0.33|< 0.05
91483493|NCT00137631|182840683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||<|0.05||95.0|1.05|1.68|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.68|1.05|< 0.05
91631258|NCT01426009|183155429|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0676|STANDARD_ERROR_OF_MEAN|0.0184||0.0006|TWO_SIDED|95.0|0.0307|0.1046|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1046|0.0307|0.0006
91631259|NCT01426009|183155429|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1021|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0644|0.1398|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1398|0.0644|<0.0001
91665952|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.95|STANDARD_ERROR_OF_MEAN|2.49||0.4346|TWO_SIDED|90.0|-6.06|2.16||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.16|-6.06|0.4346
91665953|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.03|STANDARD_ERROR_OF_MEAN|2.49||0.4173|TWO_SIDED|90.0|-6.15|2.09||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.09|-6.15|0.4173
91665954|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|2.56||0.7036|TWO_SIDED|90.0|-5.21|3.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.26|-5.21|0.7036
91665955|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.64|STANDARD_ERROR_OF_MEAN|2.54||0.2993|TWO_SIDED|90.0|-6.84|1.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.56|-6.84|0.2993
91665956|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.08|STANDARD_ERROR_OF_MEAN|2.57||0.9751|TWO_SIDED|90.0|-4.16|4.32||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.32|-4.16|0.9751
91665957|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.23|STANDARD_ERROR_OF_MEAN|2.86||0.1408|TWO_SIDED|90.0|-0.5|8.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.96|-0.50|0.1408
91665958|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.7|STANDARD_ERROR_OF_MEAN|2.83||0.0986|TWO_SIDED|90.0|0.02|9.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.38|0.02|0.0986
91665959|NCT02554877|183225460|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.79|STANDARD_ERROR_OF_MEAN|2.85||0.1851|TWO_SIDED|90.0|-0.92|8.5||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.50|-0.92|0.1851
91665960|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.39|STANDARD_ERROR_OF_MEAN|2.17||0.8559|TWO_SIDED|90.0|-3.19|3.98||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||3.98|-3.19|0.8559
91665961|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.97|STANDARD_ERROR_OF_MEAN|2.17||0.1729|TWO_SIDED|90.0|-0.62|6.55||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.55|-0.62|0.1729
91483494|NCT00137631|182840684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17|||<|0.05||95.0|0.69|1.98|||Mixed Models Analysis|||||1.98|0.69|< 0.05
91483495|NCT00137631|182840685|SUPERIORITY_OR_OTHER||Rate Ratio|0.49|||<|0.05||95.0|0.28|0.87|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||0.87|0.28|< 0.05
91483496|NCT00137631|182840686|SUPERIORITY_OR_OTHER||Rate Ratio|0.8|||<|0.05||95.0|0.42|1.53|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.53|0.42|< 0.05
91483497|NCT00351000|182840701|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||t-test, 2 sided|||||||0.956
91483498|NCT00351000|182840702|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
91483499|NCT00085709|182840703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Cox|The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.||Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.||||<0.001
91483500|NCT00085709|182840704|SUPERIORITY_OR_OTHER||||||<|0.0025||95.0|||||Test of difference of proportions|||Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.||||<0.0025
91483501|NCT04131556|182840706|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least square means|67.76|||||TWO_SIDED|90.0|59.5|77.16|||ANOVA|||||77.16|59.50|
91665962|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|8.45|STANDARD_ERROR_OF_MEAN|2.18||0.0002|TWO_SIDED|90.0|4.84|12.06||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||12.06|4.84|0.0002
91665963|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.37|STANDARD_ERROR_OF_MEAN|2.55||0.8837|TWO_SIDED|90.0|-3.85|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||4.59|-3.85|0.8837
91665964|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.62|STANDARD_ERROR_OF_MEAN|2.55||0.1573|TWO_SIDED|90.0|-0.6|7.84||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||7.84|-0.60|0.1573
91665965|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.88|STANDARD_ERROR_OF_MEAN|2.56||0.0024|TWO_SIDED|90.0|3.65|12.11||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||12.11|3.65|0.0024
91665966|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.59|STANDARD_ERROR_OF_MEAN|2.51||0.1538|TWO_SIDED|90.0|-0.55|7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||7.73|-0.55|0.1538
91665967|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.39|STANDARD_ERROR_OF_MEAN|2.48||0.0789|TWO_SIDED|90.0|0.28|8.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||8.49|0.28|0.0789
91665968|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.14|STANDARD_ERROR_OF_MEAN|2.51|<|0.0001|TWO_SIDED|90.0|5.98|14.3||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||14.30|5.98|<0.0001
91483502|NCT04131556|182840706|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|62.29|||||TWO_SIDED|90.0|54.73|70.9|||ANOVA|||||70.90|54.73|
91665969|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|6.96|STANDARD_ERROR_OF_MEAN|2.78||0.0132|TWO_SIDED|90.0|2.36|11.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.56|2.36|0.0132
91665970|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.41|STANDARD_ERROR_OF_MEAN|2.75||0.0079|TWO_SIDED|90.0|2.85|11.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.96|2.85|0.0079
91665971|NCT02554877|183225461|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.83|STANDARD_ERROR_OF_MEAN|2.77||0.0001|TWO_SIDED|90.0|6.24|15.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||15.42|6.24|0.0001
91665972|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.46|STANDARD_ERROR_OF_MEAN|3.31||0.6597|TWO_SIDED|90.0|-4.01|6.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.92|-4.01|0.6597
91665973|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.02|STANDARD_ERROR_OF_MEAN|3.31||0.7583|TWO_SIDED|90.0|-4.45|6.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.49|-4.45|0.7583
91665974|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.11|STANDARD_ERROR_OF_MEAN|3.33||0.3516|TWO_SIDED|90.0|-2.39|8.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.61|-2.39|0.3516
91483503|NCT04131556|182840707|OTHER||Median Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|90.0|0.75|1.75|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.75|0.75|<.001
91665975|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.83|STANDARD_ERROR_OF_MEAN|3.38||0.5877|TWO_SIDED|90.0|-7.42|3.75||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.75|-7.42|0.5877
91483504|NCT04131556|182840707|OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|90.0|0.75|1.25|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.25|0.75|<.001
91483505|NCT04131556|182840708|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|81.27|||||TWO_SIDED|90.0|73.88|89.4|||ANOVA|||||89.40|73.88|
91483506|NCT04131556|182840708|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|78.0|||||TWO_SIDED|90.0|70.92|85.79|||ANOVA|||||85.79|70.92|
91483507|NCT04131556|182840709|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|83.52|||||TWO_SIDED|90.0|76.12|91.64|||ANOVA|||||91.64|76.12|
91631260|NCT01426009|183155429|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0918|0.1681|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||00.1681|0.0918|<0.0001
91631261|NCT01426009|183155429|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0446|STANDARD_ERROR_OF_MEAN|0.0186||0.02|TWO_SIDED|95.0|0.0073|0.082|||Mantel Haenszel||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0820|0.0073|0.0200
91631262|NCT01426009|183155429|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0813|STANDARD_ERROR_OF_MEAN|0.0284||0.006|TWO_SIDED|95.0|0.0243|0.1382|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1382|0.0243|0.0060
91631263|NCT01426009|183155429|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0385|STANDARD_ERROR_OF_MEAN|0.0183||0.0402|TWO_SIDED|95.0|0.0018|0.0752|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0752|0.0018|0.0402
91631264|NCT01426009|183155429|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0696|STANDARD_ERROR_OF_MEAN|0.0179||0.0003|TWO_SIDED|95.0|0.0337|0.1055|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1055|0.0337|0.0003
91483508|NCT04131556|182840709|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|80.36|||||TWO_SIDED|90.0|73.26|88.16|||ANOVA|||||88.16|73.26|
91483509|NCT04131556|182840712|OTHER||Median Difference (Final Values)|0.13||||0.006|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.006
91665976|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.33|STANDARD_ERROR_OF_MEAN|3.38||0.2016|TWO_SIDED|90.0|-9.92|1.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.26|-9.92|0.2016
91714293|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9835||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9835
91714294|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6668||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6668
91483510|NCT04131556|182840712|OTHER||Median Difference (Final Values)|0.13||||0.011|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.011
91631265|NCT01426009|183155429|SUPERIORITY|Day 1 analysis|Least Squares Mean|0.0501|STANDARD_ERROR_OF_MEAN|0.018||0.0074|TWO_SIDED|95.0|0.014|0.0861|||ANCOVA|||An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0861|0.0140|0.0074
91631266|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0767|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0505|0.1028|||ANCOVA||standard error of the mean difference|ACU 0-24 on Day 1||0.1028|0.0505|<0.0001
91631267|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.122|STANDARD_ERROR_OF_MEAN|0.0127|<|0.0001|TWO_SIDED|95.0|0.0965|0.1475|||ANCOVA||standard error of the Mean difference|ACU 0-24 Day 1||0.1475|0.0965|<0.0001
91631268|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1222|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.0965|0.1479|||ANCOVA||standard error of the Mean difference|AUC 0-24 Day 1||0.1479|0.0965|<0.0001
91631269|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1625|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.1362|0.1888|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1888|0.1362|<0.0001
91631270|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.169|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1434|0.1946|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1946|0.1434|<0.0001
91631271|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0189|<|0.0001|TWO_SIDED|95.0|0.0716|0.1473|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1473|0.0716|<0.0001
91631272|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|0.0812|0.1379|||ANCOVA||standard error of the Mean difference|AUC 0-24 on Day 7||0.1379|0.0812|<0.0001
91631273|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1271|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.0993|0.1548|||ANCOVA||standard error of the Mean difference|AUC0-24 on Day 7||0.1548|0.0993|<0.0001
91631274|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.145|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1169|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1169|<0.0001
91631275|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1688|STANDARD_ERROR_OF_MEAN|0.0142|<|0.0001|TWO_SIDED|95.0|0.1403|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.1403|<0.0001
91631276|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1396|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.1117|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1117|<0.0001
91631277|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1183|STANDARD_ERROR_OF_MEAN|0.0194|<|0.0001|TWO_SIDED|95.0|0.0795|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.0795|<0.0001
91631278|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1038|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0776|0.1301|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1301|0.0776|<0.0001
91631279|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1468|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1212|0.1724|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1724|0.1212|<0.0001
91714295|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2823||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2823
91483511|NCT00145600|182840727|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.886|||||TWO_SIDED|95.0|0.82|0.953||||||||0.953|0.820|
91714296|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5687
91483512|NCT00145600|182840727|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
91631280|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1579|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1322|0.1837|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1837|0.1322|<0.0001
91631281|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1919|STANDARD_ERROR_OF_MEAN|0.0132|<|0.0001|TWO_SIDED|95.0|0.1655|0.2184|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2184|0.1655|<0.0001
91631282|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1994|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1738|0.2251|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2251|0.1738|<0.0001
91631283|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1248|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0872|0.1625|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1625|0.0872|<0.0001
91714297|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0043||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0043
91714298|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8662||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8662
91714299|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3656||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3656
91792420|NCT02278341|183462581|SUPERIORITY||LSM Difference|0.149|||=|0.031|TWO_SIDED|95.0|0.014|0.284||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.284|0.014|=0.031
91483513|NCT00145600|182840727|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
91483514|NCT00145600|182840727|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.793|||||TWO_SIDED|95.0|0.726|0.86||||||||0.860|0.726|
91631284|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1279|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.097|0.1587|||ANCOVA|standard error of the Mean difference|standard error of the Mean difference|AUC 0-12 on day 7||0.1587|0.0970|<0.0001
91631285|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1454|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.1151|0.1756|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1756|0.1151|<0.0001
91631286|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1699|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.2004|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2004|0.1393|<0.0001
91631287|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1814|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.1503|0.2125|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2125|0.1503|<0.0001
91631288|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1697|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.201|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.201|0.1393|<0.0001
91631289|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1384|STANDARD_ERROR_OF_MEAN|0.0216|<|0.0001|TWO_SIDED|95.0|0.0951|0.1817|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1817|0.0951|<0.0001
91665977|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-6.49|STANDARD_ERROR_OF_MEAN|3.39||0.0568|TWO_SIDED|90.0|-12.08|-0.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-0.89|-12.08|0.0568
91665978|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.94|STANDARD_ERROR_OF_MEAN|3.36||0.3827|TWO_SIDED|90.0|-8.48|2.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.61|-8.48|0.3827
91483515|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0|||||Wilcoxon signed rank test|||||||0.3097
91483516|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483517|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483518|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483519|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483520|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483521|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197||95.0|||||Wilcoxon signed rank test|||||||0.0197
91483522|NCT00145600|182840728|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631290|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0471|STANDARD_ERROR_OF_MEAN|0.0157|<|0.0001|TWO_SIDED|95.0|0.0155|0.0786|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.0786|0.0155|<0.0001
91631291|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0918|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.0611|0.1226|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1226|0.0611|<0.0001
91665979|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-5.31|STANDARD_ERROR_OF_MEAN|3.33||0.1126|TWO_SIDED|90.0|-10.81|0.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||0.20|-10.81|0.1126
91665980|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.17|STANDARD_ERROR_OF_MEAN|3.36||0.216|TWO_SIDED|90.0|-9.73|1.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.38|-9.73|0.2160
91714300|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0806||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0806
91483523|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483524|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631292|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0829|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.0519|0.1139|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1139|0.0519|<0.0001
91631293|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.0158|<|0.0001|TWO_SIDED|95.0|0.0982|0.1617|||ANCOVA||standard error of the Mean difference|AUC 12-24 o day 1||0.1617|0.0982|<0.0001
91631294|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1369|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.1061|0.1678|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1678|0.1061|<0.0001
91631295|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0934|STANDARD_ERROR_OF_MEAN|0.0221|<|0.0001|TWO_SIDED|95.0|0.049|0.1377|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1377|0.0490|<0.0001
91792421|NCT02278341|183462582|SUPERIORITY||LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.125|0.346|||Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.346|0.125|<0.001
91631296|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0879|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.0573|0.1186|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1186|0.0573|<0.0001
91631297|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0788|0.1388|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1388|0.0788|<0.0001
91631298|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1175|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.0872|0.1478|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1478|0.0872|<0.0001
91631299|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1532|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1226|0.1838|||ANCOVA||standard error of the Mean difference|||0.1838|0.1226|<0.0001
91631300|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.1048|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0747|0.135|||ANCOVA||standard error of the Mean difference|||0.1350|0.0747|<0.0001
91631301|NCT01426009|183155430|SUPERIORITY||Least Squares Mean Difference (SE)|0.0993|STANDARD_ERROR_OF_MEAN|0.0202|<|0.0001|TWO_SIDED|95.0|0.0589|0.1398|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1398|0.0589|<0.0001
91631302|NCT00515099|183155523|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.60
91631303|NCT00515099|183155524|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL||||0.40
91631304|NCT00515099|183155525|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 12||||0.59
91631305|NCT00515099|183155525|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 24||||0.14
91631306|NCT00515099|183155527|SUPERIORITY_OR_OTHER||||||>|0.099|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 12||||>0.099
91631307|NCT00515099|183155527|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 24||||0.75
91483525|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
91631308|NCT00515099|183155528|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.38
91631309|NCT00515099|183155528|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.33
91631310|NCT00515099|183155529|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 12||||0.07
91631311|NCT00515099|183155529|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 24||||0.16
91483526|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631312|NCT03342404|183155530|SUPERIORITY||Difference in proportions|77.1|||||TWO_SIDED|95.0|63.4|87.0|||||The difference in proportions (luspatercept - placebo) and 95% CI were estimated from the exact unconditional test|||87.0|63.4|
91631313|NCT03342404|183155530|SUPERIORITY||Risk Difference (RD)|77.1|||||TWO_SIDED|95.0|68.7|85.5|||||The common risk difference (luspatercept - placebo) and 95% CI were estimated from the CMH test stratified by baseline Hb category and baseline NTDT-PRO T/W domain score category|||85.5|68.7|
91631314|NCT03342404|183155531|SUPERIORITY||Mean Difference (Net)|-0.48||||0.0924|TWO_SIDED|95.0|-1.03|0.08|||ANCOVA|||||0.08|-1.03|0.0924
91631315|NCT03342404|183155532|SUPERIORITY||Mean Difference (Net)|1.42|||<|0.0001|TWO_SIDED|95.0|1.16|1.67|||ANCOVA|||||1.67|1.16|< 0.0001
91631316|NCT03342404|183155533|SUPERIORITY||Mean Difference (Net)|68.8|||<|0.0001|TWO_SIDED|95.0|54.3|80.4|||Cochran-Mantel-Haenszel|||||80.4|54.3|< 0.0001
91631317|NCT03342404|183155534|SUPERIORITY||Mean Difference (Net)|1.39||||0.2641|TWO_SIDED|95.0|-1.06|3.83|||ANCOVA|||||3.83|-1.06|0.2641
91631318|NCT03342404|183155535|SUPERIORITY||Mean Difference (Net)|-0.49||||0.0721|TWO_SIDED|95.0|-1.02|0.04|||ANCOVA|||||0.04|-1.02|0.0721
91631319|NCT03342404|183155536|SUPERIORITY||Mean Difference (Net)|1.49|||<|0.0001|TWO_SIDED|95.0|1.2|1.79|||ANCOVA|||||1.79|1.20|< 0.0001
91631320|NCT03342404|183155537|SUPERIORITY||Mean Difference (Net)|2.19||||0.0959|TWO_SIDED|95.0|-0.39|4.78|||ANCOVA|||||4.78|-0.39|0.0959
91631321|NCT03342404|183155538|SUPERIORITY||Mean Difference (Net)|-0.79||||0.051|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|||||0.00|-1.58|0.0510
91631322|NCT03342404|183155539|SUPERIORITY||Mean Difference (Net)|-1.07||||0.0047|TWO_SIDED|95.0|-1.8|-0.33|||ANCOVA|||||-0.33|-1.80|0.0047
91631323|NCT03342404|183155540|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1359|TWO_SIDED|95.0|0.8|4.0|||Cochran-Mantel-Haenszel|||||4.0|0.8|0.1359
91631324|NCT03342404|183155541|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0657|TWO_SIDED|95.0|0.9|5.4|||Cochran-Mantel-Haenszel|||||5.4|0.9|0.0657
91665981|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.54|STANDARD_ERROR_OF_MEAN|3.74||0.3443|TWO_SIDED|90.0|-2.64|9.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.72|-2.64|0.3443
91665982|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.82|STANDARD_ERROR_OF_MEAN|3.7||0.3031|TWO_SIDED|90.0|-2.3|9.94||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.94|-2.30|0.3031
91665983|NCT02554877|183225462|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.88|STANDARD_ERROR_OF_MEAN|3.72||0.8129|TWO_SIDED|90.0|-5.27|7.04||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||7.04|-5.27|0.8129
91714301|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5381||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5381
91714302|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0090
91714303|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9748||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9748
91525720|NCT00926003|182926859|SUPERIORITY|||||||0.02|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.02
91525721|NCT00926003|182926860|SUPERIORITY|||||||0.18|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.18
91631325|NCT03342404|183155542|SUPERIORITY||Mean Difference (Net)|1.39||||0.0847|TWO_SIDED|95.0|-0.19|2.96|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 24||2.96|-0.19|0.0847
91631326|NCT03342404|183155542|SUPERIORITY||Mean Difference (Net)|1.75||||0.0712|TWO_SIDED|95.0|-0.15|3.65|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 48||3.65|-0.15|0.0712
91631327|NCT03342404|183155542|SUPERIORITY||Mean Difference (Net)|1.54||||0.1633|TWO_SIDED|95.0|-0.63|3.72|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 24||3.72|-0.63|0.1633
91631328|NCT03342404|183155542|SUPERIORITY||Mean Difference (Net)|2.7||||0.0469|TWO_SIDED|95.0|0.04|5.36|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 48||5.36|0.04|0.0469
91631329|NCT03342404|183155543|SUPERIORITY||Mean Difference (Net)|-4.2||||0.4787|TWO_SIDED|95.0|-21.4|13.0|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 24||13.0|-21.4|0.4787
91714304|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3936
91714305|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1563||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.1563
91714306|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6357||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6357
91714307|NCT00676403|183320241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0133
91792422|NCT02278341|183462582|SUPERIORITY||LSM Difference|0.104|||=|0.11|TWO_SIDED|95.0|-0.024|0.232|||Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.232|-0.024|=0.110
91631330|NCT03342404|183155543|SUPERIORITY||Mean Difference (Net)|-14.6||||0.0827|TWO_SIDED|95.0|-31.5|2.4|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 48||2.4|-31.5|0.0827
91631331|NCT03342404|183155544|SUPERIORITY||Mean Difference (Net)|27.14||||0.5949|TWO_SIDED|95.0|-46.77|101.06|||ANCOVA|||Mean change from baseline in serum ferritin at Week 24||101.06|-46.77|0.5949
91665984|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.4||0.402|TWO_SIDED|90.0|-0.33|1.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.01|-0.33|0.4020
91525722|NCT00708526|182926872|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|A Bonferroni correction was used.||We compared times for discharge criteria after general anesthesia with and without the QED.||||>0.05
91631332|NCT03342404|183155544|SUPERIORITY||Mean Difference (Net)|13.46||||0.3454|TWO_SIDED|95.0|-61.01|87.93|||ANCOVA|||Mean change from baseline in serum ferritin at Week 48||87.93|-61.01|0.3454
91631333|NCT03342404|183155545|SUPERIORITY||Mean Difference (Net)|-0.09||||0.6628|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Mean change from baseline in LIC at Week 24||0.30|-0.47|0.6628
91631334|NCT03342404|183155545|SUPERIORITY||Mean Difference (Net)|0.66||||0.0859|TWO_SIDED|95.0|-0.09|1.42|||ANCOVA|||Mean change from baseline in LIC at Week 48||1.42|-0.09|0.0859
91631335|NCT03342404|183155546|SUPERIORITY||Mean Difference (Net)|22.2||||0.0013|TWO_SIDED|95.0|5.0|38.6|||Cochran-Mantel-Haenszel|||Percentage of participants who were transfusion free over 24 weeks||38.6|5.0|0.0013
91631336|NCT03342404|183155547|SUPERIORITY||Mean Difference (Net)|37.4|||<|0.0001|TWO_SIDED|95.0|20.9|53.0|||Cochran-Mantel-Haenszel|||Percentage of Participants Who are Transfusion-Free Over 48 Weeks||53.0|20.9|< 0.0001
91483527|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483528|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483529|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3624||95.0|||||Wilcoxon signed rank test|||||||0.3624
91483530|NCT00145600|182840729|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483531|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254||95.0|||||Wilcoxon signed rank test|||||||0.0254
91631337|NCT03342404|183155549|SUPERIORITY||Mean Difference (Net)|16.15||||0.1466|TWO_SIDED|95.0|-5.73|38.04|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 24||38.04|-5.73|0.1466
91631338|NCT03342404|183155549|SUPERIORITY||Mean Difference (Net)|12.44||||0.2011|TWO_SIDED|95.0|-6.72|31.59|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 48||31.59|-6.72|0.2011
91631339|NCT03342404|183155550|SUPERIORITY||Mean Difference (Net)|52.1|||<|0.0001|TWO_SIDED|95.0|36.2|66.2|||Cochran-Mantel-Haenszel|||Percentage of Participants with an Increase From Baseline ≥1.5 g/dL in Mean Hemoglobin Values in the Absence of Transfusion||66.2|36.2|< 0.0001
91631340|NCT03342404|183155551|SUPERIORITY||Mean Difference (Net)|1.7||||0.1989|TWO_SIDED|95.0|0.8|3.7|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 13 to Week 24||3.7|0.8|0.1989
91631341|NCT03342404|183155551|SUPERIORITY||Mean Difference (Net)|2.1||||0.0733|TWO_SIDED|95.0|0.9|5.0|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 37 to Week 48||5.0|0.9|0.0733
91631342|NCT03676465|183155628|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631343|NCT03676465|183155629|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631344|NCT03676465|183155630|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631345|NCT03676465|183155631|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631346|NCT03676465|183155632|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91631347|NCT03676465|183155633|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91483532|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.44|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631348|NCT03676465|183155634|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91483533|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon signed rank test|||||||0.0004
91483534|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.32||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
91631349|NCT03676465|183155635|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631350|NCT03676465|183155636|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631351|NCT03676465|183155637|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
91631352|NCT03676465|183155638|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
91631353|NCT03676465|183155639|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
91631354|NCT03676465|183155640|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
91631355|NCT03676465|183155641|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91631356|NCT00085644|183155642|SUPERIORITY_OR_OTHER||Risk Difference (RD)|37.6|||<|0.001||95.0|27.4|47.8|||Chi-squared||Risk difference is measured as a percentage.|ASAS 20 response rates of the adalimumab group were compared with the placebo group using Pearson's Chi-square test. The counts and percentages were calculated for total sample and by therapy group. Statistical tests were 2-sided. For the statistical analysis, subjects with missing data before Week 12 were considered as nonresponders. The comparisons were performed at an alpha level = 0.05.||47.8|27.4|< 0.001
91631357|NCT00085644|183155643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.985||95.0|||||ANCOVA|||||||0.985
91631358|NCT00893763|183155732|SUPERIORITY_OR_OTHER|||||||0.1763|TWO_SIDED||||||mixed effects linear model|||We compared groups in a single analytical model using a mixed effects linear model with CPIS as the response variable. For this model, group (CHX, control), day, group by day interaction, APACHE III score and hospital (VCU, USF) were modeled as fixed effects and subject was modeled as a random effect.||||0.1763
91631359|NCT00893763|183155732|SUPERIORITY_OR_OTHER|||||||0.8656|TWO_SIDED||||||Regression, Logistic|||A logistic regression analysis was performed using the binary response variable of colonization or no colonization and dependent variables for group, length of intubation, and group-by-length-of-intubation interaction. The probability of a type 1 error ( a ) was set to 0.05.||||0.8656
91631360|NCT04107935|183155762|SUPERIORITY|||||||0.983||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Mixed Models Analysis|Since baseline characteristics achieved a good balance, those variables were not entered into the propensity score matched model.||||||0.9830
91631361|NCT04107935|183155763|SUPERIORITY|||||||0.8365||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.8365
91631362|NCT04107935|183155764|SUPERIORITY|||||||0.5727||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.5727
91631363|NCT04107935|183155765|SUPERIORITY|||||||0.9381||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.9381
91631364|NCT04107935|183155767|SUPERIORITY|||||||0.608||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.608
91631365|NCT00376675|183155769|SUPERIORITY_OR_OTHER|||||||0.317|||||||Wilcoxon rank sum test|||||||0.317
91792423|NCT02278341|183462582|SUPERIORITY||LSM Difference|0.149|||=|0.036|TWO_SIDED|95.0|0.01|0.288|||Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.288|0.010|=0.036
91665985|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.06|STANDARD_ERROR_OF_MEAN|0.4||0.8789|TWO_SIDED|90.0|-0.61|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||0.73|-0.61|0.8789
91665986|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.87|STANDARD_ERROR_OF_MEAN|0.41||0.0345|TWO_SIDED|90.0|0.19|1.54||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.54|0.19|0.0345
91665987|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.28|STANDARD_ERROR_OF_MEAN|0.48||0.0087|TWO_SIDED|90.0|0.48|2.08||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.08|0.48|0.0087
91665988|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.08|STANDARD_ERROR_OF_MEAN|0.48||0.0268|TWO_SIDED|90.0|0.28|1.88||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.88|0.28|0.0268
91665989|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.49||0.0047|TWO_SIDED|90.0|0.58|2.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.19|0.58|0.0047
91714308|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|8.05||0.4133||95.0|-22.4|9.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.4|0.4133
91665990|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.07|STANDARD_ERROR_OF_MEAN|0.42||0.0116|TWO_SIDED|90.0|0.38|1.76||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.76|0.38|0.0116
91665991|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.42||0.022|TWO_SIDED|90.0|0.27|1.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.66|0.27|0.0220
91665992|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.31|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|90.0|0.62|2.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.01|0.62|0.0021
91665993|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.41|STANDARD_ERROR_OF_MEAN|0.51||0.0067|TWO_SIDED|90.0|0.56|2.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.26|0.56|0.0067
91483535|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Correlation Coefficients|||||||<0.0001
91483536|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91527817|NCT06173570|182930684|SUPERIORITY||Mean Difference (Net)|-22.39|||<|0.001|TWO_SIDED|95.0|-27.48|-17.3|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-17.30|-27.48|< 0.001
91665994|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.18|STANDARD_ERROR_OF_MEAN|0.51||0.0225|TWO_SIDED|90.0|0.33|2.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.02|0.33|0.0225
91665995|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.4|STANDARD_ERROR_OF_MEAN|0.51||0.0073|TWO_SIDED|90.0|0.55|2.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.25|0.55|0.0073
91714309|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|7.92||0.6676||95.0|-19.0|12.2|||Mixed Models Analysis|||Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.2|-19.0|0.6676
91483537|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
91483538|NCT00145600|182840730|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0061||95.0|||||Spearman Correlation Coefficients|||||||0.0061
91483539|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0687||95.0|||||Wilcoxon signed rank test|||||||0.0687
91483540|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.65|||<|0.0001||95.0|||||Spearman Correlation Coefficient|||||||<0.0001
91483541|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9478||95.0|||||Wilcoxon signed rank test|||||||0.9478
91483542|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631366|NCT00959699|183155804|SUPERIORITY_OR_OTHER||Strata-Adjusted Difference|33.7||||0.0008|TWO_SIDED|95.0|14.1|53.3||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) was not possible due to sparse data.||53.3|14.1|0.0008
91483543|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2999||95.0|||||Wilcoxon signed rank test|||||||0.2999
91483544|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631367|NCT00959699|183155805|SUPERIORITY_OR_OTHER||Observed Difference|34.2||||0.0007|TWO_SIDED|95.0|14.5|53.9||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution||53.9|14.5|0.0007
91631368|NCT02858713|183155812|SUPERIORITY||Odds Ratio (OR)|2.99|||=|0.004|TWO_SIDED|95.0|1.42|6.28|||Regression, Logistic|||||6.28|1.42|=0.004
91631369|NCT02858713|183155813|SUPERIORITY||Coefficient|-0.415|||=|0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change baseline to week 4||0.939|-1.770|=0.545
91631370|NCT02858713|183155813|SUPERIORITY||Coefficient|-0.415||||0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change from baseline to week 4||0.939|-1.770|0.545
91631371|NCT02858713|183155813|SUPERIORITY||Coefficient|-0.581||||0.45|TWO_SIDED|95.0|-2.099|0.938|||Regression, Linear|||DLQI: Change from baseline to week 8||0.938|-2.099|0.450
91631372|NCT02858713|183155813|SUPERIORITY||Coefficient|-0.77||||0.348|TWO_SIDED|95.0|-2.389|0.848|||Regression, Linear|||DLQI: Change from baseline to week 26||0.848|-2.389|0.348
91665996|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2391|TWO_SIDED|90.0|-0.12|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.73|-0.12|0.2391
91665997|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9912|TWO_SIDED|90.0|-0.42|0.43||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.43|-0.42|0.9912
91714310|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|8.04||0.9355||95.0|-16.5|15.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.2|-16.5|0.9355
91483545|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3121||95.0|||||Wilcoxon signed rank test|||||||0.3121
91483546|NCT00145600|182840731|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483547|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
91483548|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.57|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483549|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0282||95.0|||||Wilcoxon signed rank test|||||||0.0282
91483550|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.35||||0.0002||95.0|||||Spearman Correlation Coefficients|||||||0.0002
91483551|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0038||95.0|||||Wilcoxon signed rank test|||||||0.0038
91483552|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483553|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1474||95.0|||||Wilcoxon signed rank test|||||||0.1474
91483554|NCT00145600|182840732|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483555|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0281||95.0|||||Wilcoxon signed rank test|||||||0.0281
91483556|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.63|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631373|NCT02858713|183155814|SUPERIORITY||coefficient|0.4||||0.047|TWO_SIDED|95.0|0.005|0.795|||Regression, Linear|||LS-PGA: Change from baseline to week 4||0.795|0.005|0.047
91631374|NCT02858713|183155814|SUPERIORITY||Coefficient|0.091||||0.662|TWO_SIDED|95.0|-0.321|0.504|||Regression, Linear|||LS-PGA: Change from baseline to week 8||0.504|-0.321|0.662
91631375|NCT02858713|183155814|SUPERIORITY||Coefficient|0.18||||0.424|TWO_SIDED|95.0|-0.264|0.625|||Regression, Linear|||LS-PGA: Change from baseline to week 26||0.625|-0.264|0.424
91631376|NCT01388491|183155838|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.8||||0.5892|TWO_SIDED|95.0|-54.75|31.17||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.17|-54.75|0.5892
91631377|NCT01388491|183155839|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.0||||0.839|TWO_SIDED|95.0|-25.96|31.94||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.94|-25.96|0.839
91665998|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.193|TWO_SIDED|90.0|-0.09|0.77||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.77|-0.09|0.1930
91483557|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Wilcoxon signed rank test|||||||0.0050
91631378|NCT01388491|183155840|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.8||||0.0021|TWO_SIDED|95.0|-7.87|-1.77||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||-1.77|-7.87|0.0021
91631379|NCT01388491|183155841|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.2||||0.2312|TWO_SIDED|95.0|-2.08|8.58||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||8.58|-2.08|0.2312
91631380|NCT01388491|183155842|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.6||||0.344|TWO_SIDED|95.0|-1.7|4.85||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||4.85|-1.70|0.3440
91631381|NCT01388491|183155843|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.3||||0.2522|TWO_SIDED|95.0|-0.24|0.92||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.92|-0.24|0.2522
91631382|NCT01388491|183155844|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.9||||0.0143|TWO_SIDED|95.0|0.58|5.13||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.13|0.58|0.0143
91631383|NCT01388491|183155845|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.5||||0.8507|TWO_SIDED|95.0|-4.87|5.91||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.91|-4.87|0.8507
91631384|NCT01388491|183155846|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0459|TWO_SIDED|95.0|0.0|0.14||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.14|0.00|0.0459
91631385|NCT01388491|183155847|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0318|TWO_SIDED|95.0|0.01|0.26||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.26|0.01|0.0318
91631386|NCT01388491|183155848|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|361.6||||0.1148|TWO_SIDED|95.0|-88.45|811.61||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||811.61|-88.45|0.1148
91631387|NCT01388491|183155849|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.2||||0.7136|TWO_SIDED|95.0|-35.92|52.39||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||52.39|-35.92|0.7136
91631388|NCT01388491|183155850|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.3903|TWO_SIDED|95.0|-0.29|0.11||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.11|-0.29|0.3903
91665999|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.0038|TWO_SIDED|90.0|0.35|1.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||1.25|0.35|0.0038
91692033|NCT02174627|183278563|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% confidence interval (CI) of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|1.27|1.43|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.43|1.27|<0.001
91483558|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.45|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483559|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon signed rank test|||||||0.0005
91483560|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
91483561|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||95.0|||||Wilcoxon signed rank test|||||||0.0552
91666000|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.57|STANDARD_ERROR_OF_MEAN|0.27||0.0394|TWO_SIDED|90.0|0.12|1.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.02|0.12|0.0394
91666001|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.48|STANDARD_ERROR_OF_MEAN|0.28||0.0862|TWO_SIDED|90.0|0.02|0.93||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||0.93|0.02|0.0862
91666002|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.05|STANDARD_ERROR_OF_MEAN|0.34||0.0024|TWO_SIDED|90.0|0.48|1.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.61|0.48|0.0024
91666003|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.92|STANDARD_ERROR_OF_MEAN|0.34||0.0068|TWO_SIDED|90.0|0.37|1.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.48|0.37|0.0068
91666004|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.86|STANDARD_ERROR_OF_MEAN|0.34||0.0132|TWO_SIDED|90.0|0.29|1.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.42|0.29|0.0132
91666005|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.45||0.0024|TWO_SIDED|90.0|0.65|2.14||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||2.14|0.65|0.0024
91483562|NCT00145600|182840733|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483563|NCT00145600|182840734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91666006|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.15|STANDARD_ERROR_OF_MEAN|0.45||0.0115|TWO_SIDED|90.0|0.4|1.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.89|0.40|0.0115
91666007|NCT02554877|183225463|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.45||0.0344|TWO_SIDED|90.0|0.22|1.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.72|0.22|0.0344
91666008|NCT00538031|183225482|OTHER|||||||0.61|||||||Log Rank|||||||0.61
91666009|NCT00538031|183225483|OTHER|||||||0.95|||||||Log Rank|||||||0.95
91666010|NCT02450539|183225484|SUPERIORITY||Hazard Ratio (HR)|1.765||||0.0068|TWO_SIDED|95.0|1.165|2.672|||Stratified log-rank test.||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.672|1.165|0.0068
91792424|NCT02278341|183462587|SUPERIORITY||Hazard Ratio (HR)|1.154|||=|0.164|TWO_SIDED|95.0|0.943|1.411||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.411|0.943|=0.164
91666011|NCT02450539|183225487|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1746|TWO_SIDED|95.0|0.879|2.022|||Stratified log-rank test||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).\]||2.022|0.879|0.1746
91666012|NCT02450539|183225488|SUPERIORITY||Rate Difference|-17.9|||||TWO_SIDED|95.0|-29.3|-6.6|||||Confidence intervals are based on the normal approximation to the binomial.|||-6.6|-29.3|
91483564|NCT00145600|182840734|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.53|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483565|NCT00145600|182840734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxan signed rank test|||||||<0.0001
91483566|NCT00145600|182840734|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.68|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483567|NCT00145600|182840734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Wilcoxon signed rank test|||||||0.0017
91483568|NCT00145600|182840734|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91666013|NCT02450539|183225489|SUPERIORITY||Rate Difference|-13.2|||||TWO_SIDED|95.0|-29.2|2.8|||||Confidence intervals are based on the normal approximation to the binomial.|||2.8|-29.2|
91666014|NCT02450539|183225490|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.7039|TWO_SIDED|95.0|0.502|2.792|||Stratified Log Rank||Stratified Cox regression model.|Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.792|0.502|0.7039
91666015|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|||||||||Headache||||
91666016|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|||||||||Diarrhea||||
91666017|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Mean core symptom severity||||
91666018|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|||||||||Mean interference||||
91483569|NCT00145600|182840735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2758||95.0|||||Wilcoxon signed rank test|||||||0.2758
91483570|NCT00145600|182840735|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91666019|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean lung cancer symptom severity||||
91666020|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|||||||||Mean core plus lung cancer symptom severity||||
91666021|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean brain tumor symptom severity||||
91666022|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|||||||||Mean core plus lung worst 5 symptoms severity||||
91666023|NCT02450539|183225491|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Rash||||
91714311|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|7.97||0.9355||95.0|-15.1|16.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-15.1|0.9355
91483571|NCT00145600|182840735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1731||95.0|||||Wilcoxon signed rank test|||||||0.1731
91483572|NCT00145600|182840735|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483573|NCT00145600|182840735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0|||||Wilcoxon signed rank test|||||||0.0846
91483574|NCT00145600|182840735|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483575|NCT00145600|182840736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4263||95.0|||||Wilcoxon signed rank test|||||||0.4263
91483576|NCT00145600|182840736|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483577|NCT00145600|182840736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483578|NCT00145600|182840736|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91666024|NCT02450539|183225492|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|||||||||EQ VAS Overall Self-rated Health Score||||
91666025|NCT02450539|183225493|SUPERIORITY||Median Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|||||||||EQ-5D-5L Index Value||||
91666026|NCT03060486|183225498|OTHER||Signed Rank Score Difference|-60.0|||<|0.0001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<.0001
91666027|NCT05143047|183225505|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91666028|NCT05143047|183225506|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91666029|NCT05143047|183225507|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
91666030|NCT05143047|183225508|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
91666031|NCT05143047|183225509|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
91666032|NCT05143047|183225510|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
91666033|NCT05143047|183225511|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
91666034|NCT05143047|183225512|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91666035|NCT05143047|183225513|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
91666036|NCT02704091|183225527|SUPERIORITY|"The following Null-hypothesis was tested:~H0: λA(t) = λB (t) versus H1: λA(t) ≠ λB (t), where λ(t) represents the hazard at time t, A=diosmectite and B=placebo."|||||=|0.2524|||||||Wilcoxon-Gehan test|||The primary analysis tested the equality of time to recovery between the 2 treatment groups, applying the 2-sided Gehan-Wilcoxon test (α=5%).||||=0.2524
91666037|NCT02704091|183225528|SUPERIORITY||||||=|0.3511|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to recovery, analysed using the Gehan-Wilcoxon test.||||=0.3511
91666038|NCT02704091|183225529|SUPERIORITY||||||=|0.7285|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to first formed stool, analysed using the Gehan-Wilcoxon test.||||=0.7285
91666039|NCT02704091|183225530|SUPERIORITY||||||=|0.1807|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from first study treatment intake to last watery stool, analysed using the Gehan-Wilcoxon test.||||=0.1807
91666040|NCT02704091|183225531|SUPERIORITY||Least Squares (LS) Mean Difference|-0.04||||0.4294|TWO_SIDED|95.0|-0.15|0.07|||ANCOVA|||Comparison between the 2 treatment groups for number of stools for the overall time period, based on an analysis of covariance (ANCOVA) method for repeated measurements. The model included the number of stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||0.07|-0.15|0.4294
91631389|NCT01388491|183155851|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|14.3||||0.1731|TWO_SIDED|95.0|-6.29|34.8||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||34.80|-6.29|0.1731
91483579|NCT00145600|182840736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||Wilcoxon signed rank test|||||||0.0468
91483580|NCT00145600|182840736|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631390|NCT01425307|183155892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We hypothesized that the Alternative arm mean TCD velocity at 24 months will be less than the Standard arm mean TCD velocity plus 15cm/sec. We used Lan-DeMets boundaries to control overall Type I error rate at α = 0.05. For looks at exactly 1/3, 2/3, and 100 percent of the completed subjects, the cumulative α were estimated to be 0.0001, 0.001, and 0.05, respectively.|Mean Difference (Final Values)|4.54|||<|0.05|TWO_SIDED|95.0|0.1|8.98||P value for non inferiority was 8.82 X 10\^-16|Mixed Models Analysis|Linear mixed model||Participants were randomized at a central site, stratified by site with a block size of four, and an adaptive randomization scheme was used to balance the covariates of baseline age and TCD velocity. The treatment period lasted 24 months. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population.||8.98|0.10|<0.05
91631391|NCT01425307|183155896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91631392|NCT01425307|183155906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
91631393|NCT03128307|183155907|SUPERIORITY||||||<|0.0001||||||Assuming a priori threshold for statistical significant of p = 0.05|t-test, 2 sided|||||||< 0.0001
91631394|NCT03128307|183155908|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance of p = 0.05|t-test, 2 sided|||||||< 0.0001
91631395|NCT00121485|183155910|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.|Mean Difference (Final Values)|35.7||||2.5e-07|TWO_SIDED|95.0|24.5|46.9||Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O'Brien-Fleming spending function.|Fisher Exact|||Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVE||46.9|24.5|0.00000025
91631396|NCT02145429|183155937|OTHER||Hazard Ratio (HR)|0.32||||0.04|TWO_SIDED|95.0|0.1|0.98|||Log Rank|||||0.98|0.10|0.04
91631397|NCT02145429|183155938|OTHER||Mean Difference (Final Values)|-1.18|||<|0.001|TWO_SIDED|95.0|-2.03|-0.31|||Mixed Models Analysis|||||-0.31|-2.03|<0.001
91631398|NCT02145429|183155939|OTHER||Mean Difference (Final Values)|-0.14||||0.26|TWO_SIDED|95.0|-1.89|1.62|||Mixed Models Analysis|||||1.62|-1.89|0.26
91666041|NCT02704091|183225532|SUPERIORITY||LS Mean Difference|-0.12||||0.0465|TWO_SIDED|95.0|-0.24|0.0|||ANCOVA|||Comparison between the 2 treatment groups for number of watery stools for the overall time period, based on an ANCOVA method for repeated measurements. The model included the number of watery stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||-0.00|-0.24|0.0465
91483581|NCT00145600|182840737|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483582|NCT00145600|182840737|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0019||95.0|||||Spearman Correlation Coefficients|||||||0.0019
91483583|NCT00145600|182840737|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91483584|NCT00145600|182840737|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0704||95.0|||||Spearman Correlation Coefficients|||||||0.0704
91483585|NCT00145600|182840737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon signed rank test|||||||0.0200
91631399|NCT05706623|183155954|OTHER|Analysis of variance model|Geometric least squares (LS) mean ratio|0.8354|||||TWO_SIDED|90.0|0.5216|1.338||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on natural log (ln) transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.338|0.5216|
91631400|NCT05706623|183155956|OTHER|Analysis of variance model|Geometric LS Mean Ratio|0.9356|||||TWO_SIDED|90.0|0.5889|1.4864||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on ln transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.4864|0.5889|
91631401|NCT00576147|183155993|SUPERIORITY_OR_OTHER||Percent Sensitivity|88.0|||||TWO_SIDED|95.0|75.0|95.0||||||||95.0|75.0|
91631402|NCT00576147|183155993|SUPERIORITY_OR_OTHER||Percent Specificity|90.7|||||TWO_SIDED|95.0|86.4|93.7||||||||93.7|86.4|
91631403|NCT06408818|183156040|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
91631404|NCT06408818|183156041|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
91631405|NCT06408818|183156042|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
91631406|NCT06408818|183156043|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
91631407|NCT06408818|183156044|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
91631408|NCT06408818|183156045|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.22|TWO_SIDED||||||Regression, Linear|||||||0.22
91631409|NCT06408818|183156046|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
91631410|NCT06408818|183156047|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
91666042|NCT02412852|183225536|OTHER||||||||||||||||||\]The pharmacokinetics data are particularly sparse, and therefore substantial interpolations and imputations were required to produce an analyzable data set. Consequently, while not ideal, the Last Observation Carried Forward method was used for these data. There was a large amount of missing data which required imputation to determine results. The large amount of interpolations and imputations required for the pharmacokinetic analysis means that the pharmacokinetic results will need to be interpreted with caution. 3 X 3 Analysis of Variance used to compare Placebo to the two active groups. Missing data required imputation of available data.|||
91666043|NCT02412852|183225538|OTHER|ANOVA on only those subjects who completed testing.||||||0.05||||||The results were analyzed using an ANOVA with one between-subjects factor (Group: both placebo groups combined, 40 mg TV1001sr, and 80 mg TV1001sr); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).|ANOVA|The means of the three groups were further analyzed using a post hoc comparison procedure (the Scheffé test).||||||0.05
91483586|NCT00145600|182840737|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91666044|NCT02412852|183225539|OTHER|The composite conduction measure and the composite velocity measure were analyzed using an Analysis of Variance with one between-subjects factor (Group: combined placebo, 40 mg TV1001, and 80 mg TV1001); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).||||||0.15|||||||ANOVA|||||||.15
91666045|NCT02412852|183225540|OTHER|A 3 by 3 Analysis of Variance with one between-subjects factor (Combined placebo, 40 mg TV1001, or 80 mg TV1001) and one within-subjects factor (Visit 1, Visit 2, or Visit 3) was performed for HbA1c values.||||||0.36|||||||ANOVA|||||||.36
91666046|NCT02412852|183225541|OTHER|ANOVA to compare differences from baseline to completion of testing.||||||0.93|||||||ANOVA|||||||.93
91483587|NCT00145600|182840738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7192||95.0|||||Wilcoxon signed rank test|||||||0.7192
91483588|NCT00145600|182840738|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483589|NCT00145600|182840738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8663||95.0|||||Wilcoxon signed rank test|||||||0.8663
91483590|NCT00145600|182840738|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483591|NCT00145600|182840738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7626||95.0|||||Wilcoxon signed rank test|||||||0.7626
91631411|NCT06408818|183156048|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.63||0.22|TWO_SIDED||||||Regression, Logistic|||||||0.22
91483592|NCT00145600|182840738|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.58|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631412|NCT06408818|183156049|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.79||0.57|TWO_SIDED||||||Regression, Logistic|||||||0.57
91631413|NCT06408818|183156050|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
91631414|NCT06408818|183156051|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED||||||Regression, Linear|||||||0.45
91666047|NCT01447511|183225561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||<0.0001
91666048|NCT01447511|183225561|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.0001
91666049|NCT01447511|183225561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||<0.0001
91666050|NCT01447511|183225561|SUPERIORITY_OR_OTHER||||||=|0.3058|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||=0.3058
91666051|NCT01447511|183225561|SUPERIORITY_OR_OTHER||||||=|0.3278|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.3278
91666052|NCT01447511|183225561|SUPERIORITY_OR_OTHER||||||=|0.6155|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||=0.6155
91666053|NCT02336074|183225562|SUPERIORITY|||||||0.26||||||Treatment arms were compared in terms of absolute total HIV DNA levels (on a log10-scale) at post-randomization weeks 16 and 18 adjusted for the baseline (i.e. randomization) level and by stratum.|Regression, Linear|||||||0.26
91666054|NCT02336074|183225564|SUPERIORITY||Odds Ratio (OR)|0.41||||0.145|TWO_SIDED||||||Regression, Logistic|||"Comparison of the proportion of patients with undetectable viral outgrowth using logistic regression.~The analysis was adjusted for stratum and baseline viral outgrowth. Missing baseline values were imputed."||||0.145
91666055|NCT05604014|183225569|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
91666056|NCT05604014|183225570|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
91666057|NCT05604014|183225571|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
91666058|NCT05604014|183225572|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
91666059|NCT00840203|183225582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|88.6|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|88.6|
91666060|NCT00840203|183225583|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|82.8|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|82.8|
91666061|NCT00840203|183225584|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|94.0||||||90.0|83.0|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|83.0|
91666062|NCT00840203|183225585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|98.3||||||90.0|91.5|106.0|||||Metabolite results presented for informational purposes only.|||106|91.5|
91666063|NCT00840203|183225586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|86.7|110.0|||||Metabolite results presented for informational purposes only.|||110|86.7|
91666064|NCT00840203|183225587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|86.1|106.0|||||Metabolite results presented for informational purposes only.|||106|86.1|
91666065|NCT03349567|183225588|SUPERIORITY||Incident rate ratio|0.99||||0.35|TWO_SIDED|95.0|0.98|1.01|||Mixed Models Analysis|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antimicrobial prescription rates.||||1.01|0.98|0.35
91666066|NCT03349567|183225589|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||||1.35|0.93|
91666067|NCT03349567|183225590|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.01|||||TWO_SIDED|95.0|0.81|1.27||||||||1.27|0.81|
91483593|NCT00145600|182840739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4807||95.0|||||Wilcoxon signed rank test|||||||0.4807
91483594|NCT00145600|182840739|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.36|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91666068|NCT03349567|183225591|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.88|||||TWO_SIDED|95.0|0.58|1.34||||||||1.34|0.58|
91666069|NCT03349567|183225592|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.83|||||TWO_SIDED|95.0|0.53|1.29||||||||1.29|0.53|
91666070|NCT03349567|183225593|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91666071|NCT03349567|183225593|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
91666072|NCT03349567|183225594|SUPERIORITY|||||||0.46|||||||Regression, Logistic|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antibiotic prescription rates.||||||0.46
91666073|NCT01438060|183225602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.802|TWO_SIDED|95.0|-1.15|1.49||Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.|ANOVA||Model based estimate.|Analysis at Baseline (Day 0)||1.49|-1.15|0.802
91483595|NCT00145600|182840739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824||95.0|||||Wilcoxon signed rank test|||||||0.0824
91483596|NCT00145600|182840739|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483597|NCT00145600|182840739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0496||95.0|||||Wilcoxon signed rank test|||||||0.0496
91631415|NCT06408818|183156052|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
91631416|NCT02268942|183156092|OTHER|||||||0.0003|||||||Exact Binomial|||"Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%."||||0.0003
91631417|NCT02268942|183156093|OTHER||||||<|0.0001|||||||t-test, 1 sided|||"The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients."||||<0.0001
91631418|NCT00995215|183156094|OTHER|Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.||||||0.05||||||A P value \<0.05 was taken as indicative of statistical significance.|ANOVA|||The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.||||0.05
91631419|NCT01332851|183156095|SUPERIORITY||Cox Proportional Hazard|2.5|||=|0.043|TWO_SIDED|95.0|1.03|6.1||We used a threshold of p \< .05 as the criterion for statistical significance.|Regression, Cox||The hazard ratio of 2.5 indicates that children with parents in the control group were 2.5 times more likely to be removed from their home and placed into foster care compared to the intervention group.|Child welfare system removals were analyzed with a survival models that used condition assignment to predict hazard of being removed from the birth parent home.||6.10|1.03|=.043
91631420|NCT01332851|183156096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|0.42|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Parents in the PFR condition were 0.94 higher on sensitivity scores (on the unstandardized sensitivity measure) across the three post-intervention time points than parents in the R\&R condition. The standard error (SE) of this difference was .42.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline sensitivity score, months between baseline and end of intervention, and age of child at baseline.||||<.05
91666074|NCT01438060|183225602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.169|TWO_SIDED|95.0|-2.49|0.44||ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.|ANCOVA||Model based estimate|Analysis at Week 10||0.44|-2.49|0.169
91483598|NCT00145600|182840739|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91631421|NCT01332851|183156097|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean compared to the R\&R group. (the absolute value of the standardized effect is d=.15).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline security score, months between baseline and end of intervention, and age of child at baseline||||>.05
91666075|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|0.79||||0.391|TWO_SIDED|95.0|0.47|1.35|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center||Analysis at Week 1||1.35|0.47|0.391
91666076|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|0.95||||0.766|TWO_SIDED|95.0|0.69|1.31|||Cochran-Mantel-Haenszel|CMH test with controlling for treatment and study center||Analysis at Week 2||1.31|0.69|0.766
91666077|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|1.01||||0.967|TWO_SIDED|95.0|0.76|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||1.32|0.76|0.967
91666078|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.505|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||1.19|0.71|0.505
91666079|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.59|TWO_SIDED|95.0|0.84|1.36||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||1.36|0.84|0.590
91483599|NCT00145600|182840740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0|||||Wilcoxon signed rank test|||||||0.0157
91483600|NCT00145600|182840740|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483601|NCT00145600|182840740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
91483602|NCT00145600|182840740|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483603|NCT00145600|182840740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1478||95.0|||||Wilcoxon signed rank test|||||||0.1478
91483604|NCT00145600|182840740|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.56|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91666080|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.374|TWO_SIDED|95.0|0.89|1.37||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||1.37|0.89|0.374
91483605|NCT00145600|182840741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831||95.0|||||Wilcoxon signed rank test|||||||0.0831
91483606|NCT00145600|182840741|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.25||||0.0027||95.0|||||Spearman Correlation Coefficients|||||||0.0027
91666081|NCT01438060|183225605|SUPERIORITY_OR_OTHER||Response ratio|1.15||||0.175|TWO_SIDED|95.0|0.94|1.41||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||1.41|0.94|0.175
91666082|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|0.88||||0.753|TWO_SIDED|95.0|0.41|1.92||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 1||1.92|0.41|0.753
91666083|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|0.9||||0.6|TWO_SIDED|95.0|0.62|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 2||1.32|0.62|0.600
91666084|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|0.93||||0.673|TWO_SIDED|95.0|0.65|1.31||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 3||1.31|0.65|0.673
91666085|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|0.83||||0.255|TWO_SIDED|95.0|0.6|1.14||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 4||1.14|0.60|0.255
91666086|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|0.99||||0.958|TWO_SIDED|95.0|0.74|1.33||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 6||1.33|0.74|0.958
91666087|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.525|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 8||1.19|0.71|0.525
91483607|NCT00145600|182840741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0135||95.0|||||Wilcoxon signed rank test|||||||0.0135
91666088|NCT01438060|183225606|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.602|TWO_SIDED|95.0|0.82|1.4||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 10||1.40|0.82|0.602
91666089|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 1||||0.133
91666090|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 2||||0.282
91666091|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||||0.571
91666092|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||||0.895
91666093|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||||0.817
91666094|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||||0.795
91483608|NCT00145600|182840741|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.27||||0.0024||95.0|||||Spearman Correlation Coefficients|||||||0.0024
91666095|NCT01438060|183225610|SUPERIORITY_OR_OTHER|||||||0.564||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||||0.564
91666096|NCT01438060|183225612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.733|TWO_SIDED|95.0|-1.08|1.54|||ANCOVA|||Analysis at baseline||1.54|-1.08|0.733
91666097|NCT01438060|183225612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.001|TWO_SIDED|95.0|-2.16|-0.54|||ANOVA|||Analysis at Week 10||-0.54|-2.16|0.001
91666098|NCT00834405|183225650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|106.0||||||90.0|98.0|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|98.0|
91666099|NCT00834405|183225651|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
91666100|NCT00840281|183225652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|94.9|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|94.9|
91483609|NCT00145600|182840741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9848||95.0|||||Wilcoxon signed rank test|||||||0.9848
91483610|NCT00145600|182840741|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0974||95.0|||||Spearman Correlation Coefficients|||||||0.0974
91483611|NCT00145600|182840742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon signed rank test|||||||0.0040
91483612|NCT00145600|182840742|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483613|NCT00145600|182840742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon signed rank test|||||||0.0012
91483614|NCT00145600|182840742|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483615|NCT00145600|182840742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8108||95.0|||||Wilcoxon signed rank test|||||||0.8108
91666101|NCT00840281|183225653|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.6|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|98.6|
91666102|NCT00840281|183225654|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|98.7|
91666103|NCT01296841|183225668|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|We performed t-test statistics for univariate comparisons for continuous variables.||||||<0.05
91483616|NCT00145600|182840742|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
91483617|NCT00145600|182840743|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.874|||||TWO_SIDED|95.0|0.805|0.944||||||||0.944|0.805|
91483618|NCT00145600|182840743|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
91631422|NCT01332851|183156098|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across the two post-intervention time points was -.20 (SE=.50) lower in the PFR group than R\&R group. The standardized effect size was d=.04.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline.||||>.05
91631423|NCT01332851|183156099|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.53|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across post-intervention time points was .41 (SE=.53) higher in the PFR group than the R\&R group. The standardized effect size was d=-.07|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline competence stress score, months between baseline and end of intervention, and age of child at baseline||||>.05
91631424|NCT01332851|183156100|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean level of social and emotional development compared to the R\&R group (the absolute value of the standardized effect is d=.10).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline social-emotional competence score, months between baseline and end of intervention, and age of child at baseline.||||>.05
91631425|NCT01332851|183156101|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.66|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower mean level of problem behavior compared to the R\&R group (the absolute value of standardized effect is d= .12).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline||||>.05
91631426|NCT01332851|183156102|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.07 (SE=.08) lower for PFR compared to R\&R group.|Tested mean differences by condition at 3-month follow-up controlling for baseline score, months between baseline and the end of the intervention, and age of child and using an ANVOVA/regression model. Null hypothesis was that post-intervention means were equal.||||>.05
91631427|NCT01332851|183156103|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.06 (SE=.08) lower for PFR compared to R\&R group.|||||>.05
91631428|NCT01332851|183156104|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower atypical affective communication compared to the R\&R group (the absolute value of the standardized effect size was d=.19).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline score, months between baseline and end of intervention, and age of child at baseline||||<.05
91631429|NCT03446612|183156109|OTHER||FBF ratio difference|0.6953|STANDARD_DEVIATION|0.12998|||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (7.5 ug/min) is presented.|||||
91631430|NCT03446612|183156109|OTHER||FBF ratio difference|0.1683|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (15 ug/min) is presented.|||||
91631431|NCT03446612|183156109|OTHER||FBF ratio difference|0.3238|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (30 ug/min) is presented.|||||
91631432|NCT03446612|183156111|OTHER||FBF ratio difference|0.2968|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (3 ug/min) is presented.|||||
91666104|NCT00957021|183225688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||KSS Pain/Motion and Function Score comparison from pre-op to 1, 2 and 5 year||||<.0001
91666105|NCT00957021|183225689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Physical score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
91666106|NCT00957021|183225689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 1 year||||<.0001
91483619|NCT00145600|182840743|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
91483620|NCT00145600|182840743|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.785|||||TWO_SIDED|95.0|0.716|0.853||||||||0.853|0.716|
91483621|NCT00736879|182840747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1672|<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||Tested at alpha=0.019 applying Dunnett's adjustment|ANCOVA|||||-0.37|-1.02|<0.0001
91631433|NCT03446612|183156111|OTHER||FBF ratio difference|1.4425|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (10 ug/min) is presented.|||||
91631434|NCT03446612|183156113|OTHER||FBF ratio difference|-0.1598|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (2 umol/min) is presented.|||||
91631435|NCT03446612|183156113|OTHER||FBF ratio difference|-0.3715|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (8 umol/min) is presented.|||||
91666107|NCT00957021|183225689|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 2 year||||0.0017
91666108|NCT00957021|183225689|SUPERIORITY_OR_OTHER|||||||0.0055|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 3 year||||0.0055
91483622|NCT00736879|182840747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.1679|<|0.0001|TWO_SIDED|95.0|-1.07|-0.41|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.41|-1.07|<0.0001
91666109|NCT00957021|183225689|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 4 year||||0.0050
91666110|NCT00957021|183225689|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 5 year||||0.0018
91666111|NCT00957021|183225691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||LEAS score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
91666112|NCT02442687|183225693|OTHER|||||||0.034||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.034
91666113|NCT02442687|183225693|OTHER|||||||0.1731||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1731
91666114|NCT02442687|183225694|OTHER|||||||0.5276||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.5276
91666115|NCT02442687|183225694|OTHER|||||||0.4968||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.4968
91666116|NCT02442687|183225695|OTHER|||||||0.2591||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2591
91666117|NCT02442687|183225695|OTHER|||||||0.1806||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1806
91666118|NCT02442687|183225696|OTHER|||||||0.0882||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.0882
91666119|NCT02442687|183225696|OTHER|||||||0.253||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2530
91666120|NCT00431041|183225721|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91666121|NCT00431041|183225722|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value represents overall comparison of severity of dry mouth.|Chi-squared|||||||0.0010
91483623|NCT00736879|182840747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.50|-1.17|<0.0001
91525723|NCT00708526|182926873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||t-test, 2 sided|||The effect of the use of hypercapnia and increased ventilation on the time to recovery events was compared using multivariate analysis of variance with the Hotelling's two sample T2.-test and the two-tailed unpaired t-test; individual comparisons were by Bonferroni adjusted two tailed unpaired t-tests. The data was tested for normality before identifying statistical significance.||||0.039
91483624|NCT00736879|182840748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5481||0.0018|TWO_SIDED|95.0|-2.81|-0.65||Test was performed at alpha=0.05.|ANCOVA|||By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.||-0.65|-2.81|0.0018
91483625|NCT00736879|182840748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.5474||0.0024|TWO_SIDED|95.0|-2.76|-0.6||Test was performed at alpha=0.05.|ANCOVA|||||-0.60|-2.76|0.0024
91483626|NCT00736879|182840748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5598||0.0022|TWO_SIDED|95.0|-2.83|-0.63||Test was performed at alpha=0.05.|ANCOVA|||||-0.63|-2.83|0.0022
91525724|NCT02966002|182926894|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
91666122|NCT01822119|183225725|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
91666123|NCT01822119|183225726|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
91666124|NCT01822119|183225727|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant changes with the same value at 500 to 4000Hz||||<0.0001
91666125|NCT01822119|183225727|SUPERIORITY_OR_OTHER|||||||0.0499|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 6000Hz||||0.0499
91666126|NCT01822119|183225727|SUPERIORITY_OR_OTHER|||||||0.0632|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 8000Hz||||0.0632
91666127|NCT01822119|183225728|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.39
91666128|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz||||0.79
91666129|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz||||0.26
91666130|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz||||0.24
91666131|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz||||0.83
91666132|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz||||0.026
91666133|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz||||0.0085
91666134|NCT01822119|183225729|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||8000Hz||||0.13
91666135|NCT01822119|183225730|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant improvement with the same value at all presentation levels.||||<0.0001
91666136|NCT01822119|183225731|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||50dB||||0.55
91792425|NCT02278341|183462588|SUPERIORITY||Hazard Ratio (HR)|0.979|||=|0.917|TWO_SIDED|95.0|0.656|1.462|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.462|0.656|=0.917
91631436|NCT04445051|183156167|SUPERIORITY||Mean Difference (Final Values)|32.9||||0.01|TWO_SIDED|95.0|8.3|57.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||57.5|8.3|0.010
91631437|NCT04445051|183156167|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.007|TWO_SIDED|95.0|9.8|58.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||58.8|9.8|0.007
91631438|NCT04445051|183156167|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.908|TWO_SIDED|95.0|-23.1|25.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||25.9|-23.1|0.908
91631439|NCT04445051|183156167|SUPERIORITY||Mean Difference (Final Values)|35.3||||0.006|TWO_SIDED|95.0|10.8|59.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||59.8|10.8|0.006
91631440|NCT04445051|183156167|SUPERIORITY||Mean Difference (Final Values)|36.8||||0.005|TWO_SIDED|95.0|11.9|61.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||61.8|11.9|0.005
91631441|NCT04445051|183156167|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.899|TWO_SIDED|95.0|-23.3|26.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||26.5|-23.3|0.899
91631442|NCT04445051|183156168|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.665|TWO_SIDED|95.0|-31.9|49.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.6|-31.9|0.665
91631443|NCT04445051|183156168|SUPERIORITY||Mean Difference (Final Values)|-18.1||||0.375|TWO_SIDED|95.0|-58.7|22.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||22.4|-58.7|0.375
91631444|NCT04445051|183156168|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.188|TWO_SIDED|95.0|-67.6|13.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||13.6|-67.6|0.188
91631445|NCT04445051|183156168|SUPERIORITY||Mean Difference (Final Values)|-18.6||||0.361|TWO_SIDED|95.0|-59.3|21.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.9|-59.3|0.361
91631446|NCT04445051|183156168|SUPERIORITY||Mean Difference (Final Values)|-10.9||||0.6|TWO_SIDED|95.0|-52.3|30.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||30.5|-52.3|0.600
91666137|NCT01822119|183225731|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||60dB||||0.72
91666138|NCT01822119|183225731|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||80dB||||0.28
91792426|NCT02278341|183462589|SUPERIORITY||Hazard Ratio (HR)|0.867|||=|0.501|TWO_SIDED|95.0|0.573|1.313||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.313|0.573|=0.501
91483627|NCT00736879|182840749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|STANDARD_ERROR_OF_MEAN|5.859||0.0103|TWO_SIDED|95.0|-26.7|-3.6||Test was performed at alpha=0.05.|ANCOVA|||||-3.6|-26.7|0.0103
91525725|NCT02966002|182926895|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
91631447|NCT04445051|183156168|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.707|TWO_SIDED|95.0|-33.5|49.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.0|-33.5|0.707
91666139|NCT01822119|183225732|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||<0.0001
91666140|NCT01822119|183225733|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.0092
91666141|NCT01822119|183225734|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Aversiveness||||0.59
91666142|NCT01822119|183225734|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Ease of Communication||||0.71
91483628|NCT00736879|182840749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.816|<|0.0001|TWO_SIDED|95.0|-37.2|-14.3||Test was performed at alpha=0.05.|ANCOVA|||||-14.3|-37.2|<0.0001
91631448|NCT04445051|183156169|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.615|TWO_SIDED|95.0|-1.08|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-1.08|0.615
91631449|NCT04445051|183156169|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.48|TWO_SIDED|95.0|-1.17|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-1.17|0.480
91631450|NCT04445051|183156169|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.839|TWO_SIDED|95.0|-0.95|0.77||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.77|-0.95|0.839
91631451|NCT04445051|183156169|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.894|TWO_SIDED|95.0|-0.92|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.92|0.894
91631452|NCT04445051|183156169|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.195|TWO_SIDED|95.0|-1.46|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-1.46|0.195
91666143|NCT01822119|183225734|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Reverberation||||0.59
91483629|NCT00736879|182840749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.6|STANDARD_ERROR_OF_MEAN|5.962|<|0.0001|TWO_SIDED|95.0|-44.3|-20.8||Test was performed at alpha=0.05.|ANCOVA|||||-20.8|-44.3|<0.0001
91483630|NCT00736879|182840750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.1|STANDARD_ERROR_OF_MEAN|8.8681|<|0.0001|TWO_SIDED|95.0|-59.56|-24.61||Test was performed at alpha=0.05.|ANCOVA|||||-24.61|-59.56|<0.0001
91631453|NCT04445051|183156169|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.242|TWO_SIDED|95.0|-1.4|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.40|0.242
91631454|NCT04445051|183156170|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.639|TWO_SIDED|95.0|-1.2|0.74||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.74|-1.20|0.639
91631455|NCT04445051|183156170|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.492|TWO_SIDED|95.0|-1.3|0.63||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.63|-1.30|0.492
91631456|NCT04445051|183156170|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.828|TWO_SIDED|95.0|-1.07|0.86||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.86|-1.07|0.828
91631457|NCT04445051|183156170|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.744|TWO_SIDED|95.0|-0.81|1.13||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.13|-0.81|0.744
91483631|NCT00736879|182840750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|9.1963|<|0.0001|TWO_SIDED|95.0|-66.27|-30.03||Test was performed at alpha=0.05.|ANCOVA|||||-30.03|-66.27|<0.0001
91483632|NCT00736879|182840750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.6|STANDARD_ERROR_OF_MEAN|9.1796|<|0.0001|TWO_SIDED|95.0|-78.67|-42.5||Test was performed at alpha=0.05.|ANCOVA|||||-42.50|-78.67|<0.0001
91525726|NCT02966002|182926896|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
91525727|NCT02966002|182926897|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
91631458|NCT04445051|183156170|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.208|TWO_SIDED|95.0|-1.62|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.62|0.208
91631459|NCT04445051|183156170|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.116|TWO_SIDED|95.0|-1.77|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.77|0.116
91666144|NCT01822119|183225734|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Background noise||||0.40
91666145|NCT01822119|183225734|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Global score||||0.50
91666146|NCT02637141|183225745|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|7.1||0.7271|TWO_SIDED|95.0|-16.82|11.83|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||11.83|-16.82|0.7271
91666147|NCT02637141|183225745|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|6.39|STANDARD_ERROR_OF_MEAN|6.67||0.3438|TWO_SIDED|95.0|-7.07|19.85|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||19.85|-7.07|0.3438
91666148|NCT02637141|183225746|SUPERIORITY||LS Mean Difference|-14.32|STANDARD_ERROR_OF_MEAN|19.85||0.4746|TWO_SIDED|95.0|-54.39|25.74|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||25.74|-54.39|0.4746
91666149|NCT02637141|183225746|SUPERIORITY||LS Mean Difference|-41.24|STANDARD_ERROR_OF_MEAN|18.85||0.0343|TWO_SIDED|95.0|-79.28|-3.2|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||-3.2|-79.28|0.0343
91666150|NCT02637141|183225748|SUPERIORITY||LS Mean Difference|4402.25|STANDARD_ERROR_OF_MEAN|1717.4||0.014|TWO_SIDED|95.0|936.39|7868.1|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||7868.10|936.39|0.0140
91666151|NCT02637141|183225748|SUPERIORITY||LS Mean Difference|944.9|STANDARD_ERROR_OF_MEAN|1167.22||0.4228|TWO_SIDED|95.0|-1410.65|3300.44|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||3300.44|-1410.65|0.4228
91666152|NCT02637141|183225749|SUPERIORITY||LS Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|17.09||0.3034|TWO_SIDED|95.0|-16.68|52.29|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||52.29|-16.68|0.3034
91666153|NCT02637141|183225749|SUPERIORITY||LS Mean Difference|-6.92|STANDARD_ERROR_OF_MEAN|15.46||0.6569|TWO_SIDED|95.0|-38.11|24.28|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||24.28|-38.11|0.6569
91666154|NCT02637141|183225749|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|26.77||0.6254|TWO_SIDED|95.0|-40.86|67.2|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgG||67.20|-40.86|0.6254
91666155|NCT02637141|183225749|SUPERIORITY||LS Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|21.66||0.8955|TWO_SIDED|95.0|-40.84|46.57|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP IgG||46.57|-40.84|0.8955
91666156|NCT02637141|183225750|SUPERIORITY||Ratio of LS Means|0.83|STANDARD_ERROR_OF_MEAN|0.11||0.161|TWO_SIDED|95.0|0.63|1.08|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||Analysis of Total Weekly Bowel Movements at Week 12||1.08|0.63|0.1610
91666157|NCT02637141|183225750|SUPERIORITY||Ratio of LS Means|1.03|STANDARD_ERROR_OF_MEAN|0.13||0.781|TWO_SIDED|95.0|0.81|1.32|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||||1.32|0.81|0.7810
91666158|NCT02637141|183225752|SUPERIORITY||LS Mean Difference|-13.44|STANDARD_ERROR_OF_MEAN|12.33||0.2761|TWO_SIDED|95.0|-37.66|10.77|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||10.77|-37.66|0.2761
91666159|NCT02637141|183225752|SUPERIORITY||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|11.66||0.8221|TWO_SIDED|95.0|-25.51|20.27|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||20.27|-25.51|0.8221
91666160|NCT02637141|183225753|SUPERIORITY||LS Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|2.1||0.1908|TWO_SIDED|95.0|-6.89|1.3|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||1.3|-6.89|0.1908
91666161|NCT02637141|183225753|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.98||0.4088|TWO_SIDED|95.0|-5.53|2.25|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||2.25|-5.53|0.4088
91666162|NCT03031795|183225754|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance was set at \< 0.05 for each row comparison with no adjustment for multiple comparisons.|Wilcoxon rank sum test|||"A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from very severe (8) to severe pain (6) or from moderate pain (4) to mild pain (2)."||||< 0.05
91666163|NCT02705716|183225759|OTHER||Least Square (LS) Mean Difference|-0.12||||0.5191|TWO_SIDED|95.0|-0.497|0.252|||ANCOVA|From ANCOVA Model, Response: change from baseline in Schiff sensitivity score Factors: treatment \& site Covariates: baseline Schiff sensitivity score|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||0.252|-0.497|0.5191
91666164|NCT02670551|183225777|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.0331|TWO_SIDED|95.0|-4.6|-0.4||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.4|-4.6|0.0331
91692034|NCT02174627|183278564|SUPERIORITY||Relative Risk|9.12|||<|0.001|TWO_SIDED|95.0|7.63|10.89|||Cochran-Mantel-Haenszel|||Comparison of the percentage of responders for roxadustat versus placebo was analysed using a Cochran-Mantel-Haenszel test adjusting for baseline Hb, baseline eGFR, geographic region and CV history.||10.89|7.63|<0.001
91631460|NCT04445051|183156171|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.798|TWO_SIDED|95.0|-0.75|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.75|0.798
91631461|NCT04445051|183156171|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.556|TWO_SIDED|95.0|-1.1|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-1.10|0.556
91631462|NCT04445051|183156171|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.399|TWO_SIDED|95.0|-1.21|0.49||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.49|-1.21|0.399
91631463|NCT04445051|183156171|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.198|TWO_SIDED|95.0|-0.3|1.41||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.41|-0.30|0.198
91631464|NCT04445051|183156171|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.365|TWO_SIDED|95.0|-1.27|0.48||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.48|-1.27|0.365
91631465|NCT04445051|183156171|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.033|TWO_SIDED|95.0|-1.82|-0.08||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.08|-1.82|0.033
91666165|NCT02670551|183225777|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.0103|TWO_SIDED|95.0|-5.1|-0.9||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.9|-5.1|0.0103
91792427|NCT02278341|183462590|SUPERIORITY||LSM Difference|-0.006|||=|0.507|TWO_SIDED|95.0|-0.02|0.01||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||0.01|-0.02|=0.507
91631466|NCT04445051|183156172|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.882|TWO_SIDED|95.0|-0.83|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.83|0.882
91631467|NCT04445051|183156172|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.478|TWO_SIDED|95.0|-1.21|0.57||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.57|-1.21|0.478
91631468|NCT04445051|183156172|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.391|TWO_SIDED|95.0|-1.27|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-1.27|0.391
91631469|NCT04445051|183156172|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.657|TWO_SIDED|95.0|-0.69|1.09||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.09|-0.69|0.657
91631470|NCT04445051|183156172|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.125|TWO_SIDED|95.0|-1.62|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.62|0.125
91631471|NCT04445051|183156172|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.051|TWO_SIDED|95.0|-1.81|0.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.00|-1.81|0.051
91631472|NCT04445051|183156173|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.877|TWO_SIDED|95.0|-0.83|0.97||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.97|-0.83|0.877
91666166|NCT02670551|183225778|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0714|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||0.0|-0.5|0.0714
91666167|NCT02670551|183225778|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.0662|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.0|-0.5|0.0662
91666168|NCT04476277|183225779|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91666169|NCT04476277|183225781|OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
91666170|NCT04476277|183225782|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91666171|NCT04476277|183225783|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91666172|NCT04476277|183225784|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91666173|NCT04476277|183225785|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
91666174|NCT04476277|183225786|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
91666175|NCT04476277|183225787|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
91666176|NCT04476277|183225788|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
91666177|NCT04476277|183225789|OTHER|||||||0.43|||||||t-test, 2 sided|||||||0.43
91666178|NCT04476277|183225790|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91666179|NCT04476277|183225791|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
91666180|NCT04476277|183225792|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91666181|NCT00849797|183225793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|90.86||||||90.0|85.47|96.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.60|85.47|
91666182|NCT00849797|183225794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|96.59|100.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.66|96.59|
91483633|NCT00736879|182840751|SUPERIORITY_OR_OTHER||percent difference|18.9|STANDARD_ERROR_OF_MEAN|7.38||0.0157|TWO_SIDED|95.0|3.6|34.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||34.3|3.6|0.0157
91483634|NCT00736879|182840751|SUPERIORITY_OR_OTHER||Percent Difference|8.8|STANDARD_ERROR_OF_MEAN|7.65||0.2512|TWO_SIDED|95.0|-6.2|23.8||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.8|-6.2|0.2512
91666183|NCT00849797|183225795|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.74||||||90.0|96.71|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.80|96.71|
91666184|NCT00849797|183225796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.5||||||90.0|95.66|100.48|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||100.48|95.66|
91666185|NCT00849797|183225797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.29||||||90.0|98.96|101.64|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||101.64|98.96|
91666186|NCT00849797|183225798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.08||||||90.0|98.91|101.27|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||101.27|98.91|
91666187|NCT02153645|183225799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.9||0.179|TWO_SIDED|95.0|-13.9|2.6|||ANCOVA|||||2.6|-13.9|0.179
91666188|NCT02153645|183225799|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.95||0.458|TWO_SIDED|95.0|-11.2|5.1|||ANCOVA|||||5.1|-11.2|0.458
91666189|NCT01139762|183225801|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.41||||0.001|TWO_SIDED|95.0|-2.27|-0.55|||Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.55|-2.27|0.001
91666190|NCT01139762|183225803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14||P-value is for IPSS storage (irritative) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.87|0.007
91692035|NCT02174627|183278565|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.91|1.35|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.35|0.91|<0.001
91483635|NCT00736879|182840751|SUPERIORITY_OR_OTHER||Percent Difference|14.5|STANDARD_ERROR_OF_MEAN|8.069||0.0726|TWO_SIDED|95.0|-1.3|30.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||30.3|-1.3|0.0726
91483636|NCT00736879|182840752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.7954||0.3163|TWO_SIDED|95.0|-2.37|0.77||Test was performed at alpha=0.05.|ANCOVA|||||0.77|-2.37|0.3163
91666191|NCT01139762|183225803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.04|TWO_SIDED|95.0|-0.8|-0.02||P-value is for IPSS storage (irritative) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.02|-0.80|0.040
91666192|NCT01139762|183225803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.107|TWO_SIDED|95.0|-0.75|0.07||P-value is for IPSS storage (irritative) subscore - 26 weeks|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.07|-0.75|0.107
91666193|NCT01139762|183225803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.69|-0.68||P-value is for IPSS voiding (obstructive) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.68|-1.69|<0.001
91666194|NCT01139762|183225803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.62|-0.46||P-value is for IPSS voiding (obstructive) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.46|-1.62|<0.001
91666195|NCT01139762|183225803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73||||0.015|TWO_SIDED|95.0|-1.32|-0.14||P-value is IPSS voiding (obstructive) subscore - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-1.32|0.015
91666196|NCT01139762|183225804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.14||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.50|<0.001
91666197|NCT01139762|183225804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.051|TWO_SIDED|95.0|-0.38|0.0||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.00|-0.38|0.051
91666198|NCT01139762|183225804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.107|TWO_SIDED|95.0|-0.38|0.04||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.04|-0.38|0.107
91666199|NCT01139762|183225805|SUPERIORITY_OR_OTHER||LS Mean Difference|4.85|||<|0.001|TWO_SIDED|95.0|3.49|6.21||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.21|3.49|<0.001
91483637|NCT00736879|182840752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.8154|||TWO_SIDED|95.0|-2.22|0.99|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.99|-2.22|
91483638|NCT00736879|182840752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.8238|||TWO_SIDED|95.0|-3.09|0.16|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.16|-3.09|
91483639|NCT02869438|182840802|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0707|TWO_SIDED|95.0|-0.007|0.161|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||0.161|-0.007|0.0707
91666200|NCT01139762|183225805|SUPERIORITY_OR_OTHER||LS Mean Difference|4.08|||<|0.001|TWO_SIDED|95.0|2.55|5.6||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||5.60|2.55|<0.001
91666201|NCT01139762|183225805|SUPERIORITY_OR_OTHER||LS Mean Difference|4.73|||<|0.001|TWO_SIDED|95.0|3.15|6.31||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.31|3.15|<0.001
91666202|NCT01139762|183225806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.4||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.40|0.61|<0.001
91666203|NCT01139762|183225806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.51|0.61|<0.001
91666204|NCT01139762|183225806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.74|1.69||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.69|0.74|<0.001
91483640|NCT02869438|182840802|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.7747|TWO_SIDED|95.0|-0.077|0.104|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||0.104|-0.077|0.7747
91483641|NCT02869438|182840802|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.0969|TWO_SIDED|95.0|-0.014|0.173|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||0.173|-0.014|0.0969
91483642|NCT02869438|182840802|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.1558|TWO_SIDED|95.0|-0.022|0.135|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For average over Day 28, 56, and 84|||0.135|-0.022|0.1558
91483643|NCT02869438|182840803|SUPERIORITY||Mean Difference (Final Values)|-0.176||||0.2847|TWO_SIDED|95.0|-0.505|0.153|||Mixed Models Analysis|Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.||||0.153|-0.505|0.2847
91631473|NCT04445051|183156173|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.351|TWO_SIDED|95.0|-1.31|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-1.31|0.351
91631474|NCT04445051|183156173|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.278|TWO_SIDED|95.0|-1.38|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-1.38|0.278
91631475|NCT04445051|183156173|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.711|TWO_SIDED|95.0|-0.73|1.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.06|-0.73|0.711
91631476|NCT04445051|183156173|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.024|TWO_SIDED|95.0|-1.97|-0.15||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.15|-1.97|0.024
91666205|NCT01139762|183225807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.18|2.47||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.47|1.18|<0.001
91666206|NCT01139762|183225807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.88|2.31||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.31|0.88|<0.001
91666207|NCT01139762|183225807|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.23|2.73||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.73|1.23|<0.001
91525728|NCT01350141|182926924|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-21.81|STANDARD_ERROR_OF_MEAN|8.385||0.0137|TWO_SIDED|95.0|-38.85|-4.77|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-4.77|-38.85|0.0137
91631477|NCT04445051|183156173|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.009|TWO_SIDED|95.0|-2.14|-0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.31|-2.14|0.009
91631478|NCT05083949|183156200|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.57|STANDARD_DEVIATION|5.23||0.7792|TWO_SIDED|90.0|97.03|102.19|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.19|97.03|0.7792
91631479|NCT05083949|183156201|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.36|STANDARD_DEVIATION|10.18||0.6493|TWO_SIDED|90.0|96.39|106.59|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.59|96.39|0.6493
91631480|NCT05083949|183156202|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.63|STANDARD_DEVIATION|7.65||0.471|TWO_SIDED|90.0|97.85|105.55|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of the was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.55|97.85|0.4710
91631481|NCT05083949|183156203|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|98.11|STANDARD_DEVIATION|8.14||0.4251|TWO_SIDED|90.0|94.24|102.15|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.15|94.24|0.4251
91631482|NCT05083949|183156204|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.49|STANDARD_DEVIATION|5.25||0.7379|TWO_SIDED|90.0|96.93|102.11|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.11|96.93|0.7379
91666208|NCT01139762|183225808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|0.92|2.13||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.13|0.92|<0.001
91666209|NCT01139762|183225808|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.006|TWO_SIDED|95.0|0.27|1.54||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.54|0.27|0.006
91792428|NCT02278341|183462591|SUPERIORITY||LSM Difference|0.132|||=|0.949|TWO_SIDED|95.0|-3.9|4.16|||ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||4.16|-3.90|=0.949
91483644|NCT02869438|182840804|SUPERIORITY||Mean Difference (Final Values)|-101.0|||<|0.0001|TWO_SIDED|95.0|-118.9|-83.06|||Mixed Models Analysis|Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.||||-83.06|-118.9|<0.0001
91483645|NCT02869438|182840805|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.6384|TWO_SIDED|95.0|-0.049|0.08|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||0.08|-0.049|0.6384
91631483|NCT05083949|183156205|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.24|STANDARD_DEVIATION|7.82||0.5895|TWO_SIDED|90.0|97.4|105.24|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.24|97.40|0.5895
91631484|NCT00126425|183156233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.83||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.83|0.23|=0.004
91631485|NCT00126425|183156233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
91631486|NCT00126425|183156233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
91631487|NCT01316380|183156234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.036||0.0005||95.0|0.057|0.199||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.057|0.0005
91631488|NCT01316380|183156234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.088|0.23||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.230|0.088|<0.0001
91631489|NCT01316380|183156235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.049|0.194||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.194|0.049|0.001
91631490|NCT01316380|183156235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.037||0.0028||95.0|0.038|0.182||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.182|0.038|0.0028
91666210|NCT01139762|183225808|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.41|1.74||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.74|0.41|0.002
91483646|NCT02869438|182840805|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.148|TWO_SIDED|95.0|-0.016|0.109|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||0.109|-0.016|0.148
91483647|NCT02869438|182840805|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.4959|TWO_SIDED|95.0|-0.049|0.101|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||0.101|-0.049|0.4959
91525729|NCT01350141|182926924|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.42|STANDARD_ERROR_OF_MEAN|8.463|<|0.0001|TWO_SIDED|95.0|-63.62|-29.22|||ANCOVA|||Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-29.22|-63.62|<0.0001
91483648|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.8667|TWO_SIDED|95.0|-0.062|0.073|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 3|||0.073|-0.062|0.8667
91483649|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.2734|TWO_SIDED|95.0|-0.033|0.115|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 7|||0.115|-0.033|0.2734
91714312|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.94||0.1895||95.0|-26.1|5.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-26.1|0.1895
91631491|NCT01316380|183156236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.042||0.1714||95.0|-0.025|0.14||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|-0.025|0.1714
91631492|NCT01316380|183156236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.042||0.0119||95.0|0.023|0.188||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.188|0.023|0.0119
91631493|NCT01316380|183156237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.034||0.0003||95.0|0.058|0.192||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.192|0.058|0.0003
91631494|NCT01316380|183156237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.082|0.216||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.216|0.082|<0.0001
91631495|NCT01316380|183156238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.039||0.1182||95.0|-0.016|0.138||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.138|-0.016|0.1182
91631496|NCT01316380|183156238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.039||0.0102||95.0|0.024|0.178||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.178|0.024|0.0102
91631497|NCT01316380|183156240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25||||0.2155||95.0|0.03|2.24||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||2.24|0.03|0.2155
91631498|NCT01316380|183156240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.5071||95.0|0.43|5.44||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||5.44|0.43|0.5071
91631499|NCT01316380|183156241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.1217||95.0|0.29|1.16||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc).||1.16|0.29|0.1217
91631500|NCT01316380|183156241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8974||95.0|0.53|1.75||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc). The Hazard Ratio is still estimable from the Cox model.||1.75|0.53|0.8974
91631501|NCT01316380|183156242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.129||0.0872|TWO_SIDED|95.0|-0.032|0.476||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.476|-0.032|0.0872
91631502|NCT01316380|183156242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|STANDARD_ERROR_OF_MEAN|0.129||0.7995|TWO_SIDED|95.0|-0.287|0.221||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.221|-0.287|0.7995
91631503|NCT01316380|183156243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.076||0.2038|TWO_SIDED|95.0|-0.053|0.247||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.||0.247|-0.053|0.2038
91631504|NCT01316380|183156243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.076||0.9104|TWO_SIDED|95.0|-0.158|0.141||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.141|-0.158|0.9104
91631505|NCT01316380|183156244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.068||0.0559|TWO_SIDED|95.0|-0.003|0.265||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.265|-0.003|0.0559
91525730|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.825||||0.19|TWO_SIDED|95.0|0.36|169.74|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||169.74|0.36|0.1900
91631506|NCT01316380|183156244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.068||0.8795|TWO_SIDED|95.0|-0.144|0.123||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.123|-0.144|0.8795
91631507|NCT02574520|183156256|SUPERIORITY|Primary|Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.124|TWO_SIDED|95.0|-0.84|0.1|||ANOVA|Mixed model with repeated measures (MMRM) for scheduled pain measurements was estimated with time as a repeating factor within subject.|Least squares mean from the MMRM described in the Statistical Test of Hypothesis.|Pain Intensity on Movement 0-48 hr||0.10|-0.84|0.124
91631508|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation between test and reference drugs are 98% and 17.24%, respectively|Geometric mean ratio|95.204|||||TWO_SIDED|90.0|87.618|103.446|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.446|87.618|
91631509|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and coefficient of variation are 80% and 22.62%, respectively.|Geometric mean ratio|107.606|||||TWO_SIDED|90.0|96.552|119.924|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.924|96.552|
91631510|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 16.26%, respectively.|Geometric mean ratio|104.373|||||TWO_SIDED|90.0|96.504|112.883|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B= FDC (test value)|||112.883|96.504|
91631511|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 81% and 14.42%,respectively.|Geometric mean ratio|88.188|||||TWO_SIDED|90.0|82.368|94.419|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||94.419|82.368|
91631512|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 13.09%, respectively.|Geometric mean ratio|98.168|||||TWO_SIDED|90.0|92.263|104.451|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.451|92.263|
91631513|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|5-OH saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 8.02%, respectively.|Geometric mean ratio|95.023|||||TWO_SIDED|90.0|91.47|98.714|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.714|91.470|
91631514|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 15.55%, respectively.|Geometric mean ratio|97.601|||||TWO_SIDED|90.0|15.55|99.0|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99|15.55|
91631515|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 84% and 15.65%, respectively.|Geometric mean ratio|110.656|||||TWO_SIDED|90.0|102.416|119.559|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.559|102.416|
91666211|NCT01139762|183225809|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.25||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.25|0.61|<0.001
91631516|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|OH-Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.61%, respectively.|Geometric mean ratio|106.264|||||TWO_SIDED|90.0|99.826|113.117|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||113.117|99.826|
91631517|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.30%, respectively.|Geometric mean ratio|100.028|||||TWO_SIDED|90.0|95.164|105.139|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||105.139|95.164|
91631518|NCT01365091|183156268|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.38%, respectively.|Geometric mean ratio|93.644|||||TWO_SIDED|95.0|89.055|98.47|||ANCOVA|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.470|89.055|
91631519|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation are 98% and 17.24%, respectively.|Geometric mean ratio|91.508|||||TWO_SIDED|90.0|82.596|101.38|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.380|82.596|
91631520|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.66%, respectively.|Geometric mean ratio|97.437|||||TWO_SIDED|90.0|93.889|101.119|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.119|93.889|
91631521|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.43%, respectively.|Geometric mean ratio|96.77|||||TWO_SIDED|90.0|93.35|100.316|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.316|93.350|
91631522|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.37%, respectively.|Geometric mean ratio|91.585|||||TWO_SIDED|90.0|85.56|98.035|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.035|85.56|
91525731|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.518||||0.0057|TWO_SIDED|95.0|3.48|1512.1|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1512.10|3.48|0.0057
91525732|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.75||||0.0013|TWO_SIDED|95.0|3.49|175.63|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||175.63|3.49|0.0013
91525733|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.326||||0.0006|TWO_SIDED|95.0|5.26|426.01|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||426.01|5.26|0.0006
91631523|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 96.028% and 101.095%, respectively.|Geometric mean ratio|98.529|||||TWO_SIDED|90.0|96.028|101.095|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.095|96.028|
91631524|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.55%, respectively|Geometric mean ratio|96.239|||||TWO_SIDED|90.0|93.286|99.286|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.286|93.286|
91631525|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.19%, respectively.|Geometric mean ratio|102.994|||||TWO_SIDED|90.0|96.956|109.407|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||109.407|96.956|
91631526|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.135|||||TWO_SIDED|95.0|93.778|100.613|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.613|93.778|
91631527|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.18%, respectively.|Geometric mean ratio|100.01|||||TWO_SIDED|90.0|96.512|103.648|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.648|96.512|
91631528|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1:The corresponding power and the variation coefficient are 93% and 17.35%, respectively.|Geometric mean ratio|92.953|||||TWO_SIDED|90.0|85.502|101.053|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.053|85.502|
91631529|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.75%, respectively.|Geometric mean ratio|101.281|||||TWO_SIDED|95.0|98.494|104.147|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.147|98.494|
91631530|NCT01365091|183156269|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.73%, respectively.|Geometric mean ratio|100.111|||||TWO_SIDED|90.0|97.367|102.932|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.932|97.367|
91631531|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|For AUC(0-inf) metformin, Arm 1, the corresponding power and coefficient of variation are 80% and 21.06%, respectively.|Geometric mean ratio|91.494|||||TWO_SIDED|90.0|82.697|101.226|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||101.226|82.697|
91631532|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.60%, respectively.|Geometric mean ratio|97.477|||||TWO_SIDED|90.0|93.955|101.132|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.132|93.955|
91631533|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1. The corresponding power and the coefficient of variation are 99% and 07.31%, respectively.|Geometric mean ratio|96.76|||||TWO_SIDED|90.0|93.393|100.247|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||100.247|93.393|
91631534|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.25%, respectively.|Geometric mean ratio|91.548|||||TWO_SIDED|90.0|85.573|97.939|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||97.939|85.573|
91631535|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 5.38%,respectively.|Geometric mean ratio|98.535|||||TWO_SIDED|95.0|96.044|101.09|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.090|96.044|
91631536|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.52%, respectively.|Geometric mean ratio|96.258|||||TWO_SIDED|95.0|93.319|99.29|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.290|93.319|
91631537|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 11.75%, respectively.|Geometric mean ratio|102.383|||||TWO_SIDED|95.0|96.589|108.525|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||108.525|96.589|
91631538|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 5: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.187|||||TWO_SIDED|90.0|93.832|100.662|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.662|93.832|
91631539|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Sarexagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.08%, respectively.|Geometric mean ratio|100.015|||||TWO_SIDED|95.0|96.56|103.594|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.594|96.560|
91631540|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 94% and 17.13%, respectively.|Geometric mean ratio|93.219|||||TWO_SIDED|90.0|85.835|101.238|||ANCOVA|||||101.238|85.835|
91666212|NCT01139762|183225809|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.44|1.14||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.14|0.44|<0.001
91666213|NCT01139762|183225809|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.39|1.13||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.13|0.39|<0.001
91666214|NCT01139762|183225810|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.034
91666215|NCT01139762|183225811|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Van Elteren test|Van Elteren test was stratified by region.||||||0.031
91666216|NCT01139762|183225812|SUPERIORITY_OR_OTHER|||||||0.328||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.328
91666217|NCT01139762|183225813|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon Rank-Sum test|||||||0.157
91666218|NCT01139762|183225814|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|||<|0.001|TWO_SIDED|95.0|0.49|0.98||P-value is for Question 3 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.98|0.49|<0.001
91525734|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.635||||0.6611|TWO_SIDED|95.0|0.18|14.73|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||14.73|0.18|0.6611
91525735|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.486||||0.0104|TWO_SIDED|95.0|1.84|98.61|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.61|1.84|0.0104
91666219|NCT01139762|183225814|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.43|0.93||P-value is for Question 3 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.93|0.43|<0.001
91666220|NCT01139762|183225814|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|||<|0.001|TWO_SIDED|95.0|0.48|1.02||P-value is for Question 3 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.02|0.48|<0.001
91666221|NCT01139762|183225814|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.46|0.95||P-value is for Question 4 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.95|0.46|<0.001
91666222|NCT01139762|183225814|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|||<|0.001|TWO_SIDED|95.0|0.36|0.85||P-value is for Question 4 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.85|0.36|<0.001
91666223|NCT01139762|183225814|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.35|0.89||P-value is for Question 4 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.89|0.35|<0.001
91666224|NCT00840879|183225843|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.15||||||90.0|90.96|105.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.90|90.96|
91666225|NCT00840879|183225844|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.34||||||90.0|91.82|101.07|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.07|91.82|
91666226|NCT00840879|183225845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.76||||||90.0|93.31|102.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.42|93.31|
91666227|NCT01894230|183225874|EQUIVALENCE|Month 3|Slope|-0.0189|STANDARD_ERROR_OF_MEAN|0.3986||0.96|TWO_SIDED||||||Regression, Linear|||||||0.96
91666228|NCT01894230|183225874|EQUIVALENCE|Month 8|Slope|-0.2468|STANDARD_ERROR_OF_MEAN|0.4315||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
91666229|NCT01894230|183225875|EQUIVALENCE|Month 3|Slope|-11.32|STANDARD_ERROR_OF_MEAN|5.68||0.0482|TWO_SIDED||||||Regression, Linear|||||||0.0482
91483650|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.7252|TWO_SIDED|95.0|-0.068|0.098|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 14|||0.098|-0.068|0.7252
91631541|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.72%, respectively.|Geometric mean ratio|101.346|||||TWO_SIDED|90.0|98.574|104.196|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.196|98.574|
91631542|NCT01365091|183156271|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.71%, respectively.|Geometric mean ratio|100.056|||||TWO_SIDED|90.0|97.324|102.864|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.864|97.324|
91631543|NCT03398824|183156272|OTHER|Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \< 20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|response rate|30.8|||||TWO_SIDED|90.0|11.3|57.3|||||||Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \>20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|57.3|11.3|
91631544|NCT05307523|183156276|OTHER|Paired t-test for normally distributed data Wilcoxon Rank test for the not normally distributed data|||||<|0.05||||||Paired T-test for the normally distributed data and a Wilcoxon Rank test for the non-parametric data were used|Both Paired T-test and Wilcoxon Rank|The data included both normally and not normally distributed data for the baseline, mid-study, and final study assessment points.||||||<0.05
91631545|NCT02875366|183156312|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.3021|TWO_SIDED|95.0|-9.2|2.9|||Mixed effects model for repeated measure|||||2.9|-9.2|0.3021
91631546|NCT02875366|183156313|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.1894|TWO_SIDED|95.0|-8.0|1.6|||Mixed effects model for repeated measure|||||1.6|-8.0|0.1894
91631547|NCT02875366|183156314|SUPERIORITY||Least Squares Mean Difference|-15.3||||0.2328|TWO_SIDED|95.0|-40.8|10.1|||Mixed effects model for repeated measure|||||10.1|-40.8|0.2328
91631548|NCT02875366|183156315|SUPERIORITY||Least Squares Mean Difference|-1.4||||0.1203|TWO_SIDED|95.0|-3.1|0.4|||Mixed effects model for repeated measure|||||0.4|-3.1|0.1203
91631549|NCT02875366|183156316|SUPERIORITY||Least Squares Mean Difference|-149.6||||0.0439|TWO_SIDED|95.0|-295.0|-4.2|||Mixed effects model for repeated measure|||||-4.2|-295.0|0.0439
91631550|NCT02875366|183156317|SUPERIORITY||Least Squares Mean Difference|-7.5||||0.2237|TWO_SIDED|95.0|-19.8|4.7|||Mixed effects model for repeated measure|||||4.7|-19.8|0.2237
91631551|NCT02875366|183156318|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.0226|TWO_SIDED|95.0|-1.12|-0.09|||Mixed effects model for repeated measure|||||-0.09|-1.12|0.0226
91666230|NCT01894230|183225875|EQUIVALENCE|Month 8|Slope|-9.9|STANDARD_ERROR_OF_MEAN|6.333||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
91483651|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.0976|TWO_SIDED|95.0|-0.014|0.164|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 28|||0.164|-0.014|0.0976
91631552|NCT02875366|183156319|SUPERIORITY||Least Squares Mean Difference|-6.32||||0.0613|TWO_SIDED|95.0|-12.94|0.31|||Mixed effects model for repeated measure|||||0.31|-12.94|0.0613
91631553|NCT02875366|183156320|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6409|TWO_SIDED|95.0|-0.9|1.5|||Mixed effects model for repeated measure|||||1.5|-0.9|0.6409
91631554|NCT02875366|183156321|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5889|TWO_SIDED|95.0|-2.7|4.7|||Mixed effects model for repeated measure|||||4.7|-2.7|0.5889
91483652|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.6536|TWO_SIDED|95.0|-0.077|0.122|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 56|||0.122|-0.077|0.6536
91631555|NCT02875366|183156322|SUPERIORITY||Least Squares Mean Difference|3.4||||0.146|TWO_SIDED|95.0|-1.2|8.1|||Mixed effects model for repeated measure|||||8.1|-1.2|0.1460
91631556|NCT02875366|183156323|SUPERIORITY||Least Squares Mean Difference|3.5||||0.3091|TWO_SIDED|95.0|-3.4|10.4|||Mixed effects model for repeated measure|||||10.4|-3.4|0.3091
91631557|NCT02875366|183156324|SUPERIORITY||Least Squares Mean Difference|0.2||||0.3961|TWO_SIDED|95.0|-0.3|0.6|||Mixed effects model for repeated measure|||||0.6|-0.3|0.3961
91631558|NCT02875366|183156325|SUPERIORITY||Least Squares Mean Difference|0.9||||0.3905|TWO_SIDED|95.0|-1.2|3.1|||Mixed effects model for repeated measure|||||3.1|-1.2|0.3905
91631559|NCT02875366|183156326|SUPERIORITY||Least Squares Mean Difference|6.2||||0.1257|TWO_SIDED|95.0|-1.8|14.1|||Mixed effects model for repeated measure|||||14.1|-1.8|0.1257
91631560|NCT02735044|183156408|NON_INFERIORITY|Non-inferiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference in the mean change in HbA1c from baseline to month 6 was \<0.3%.|LS Mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.172|0.179||||||Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||0.179|-0.172|
91666231|NCT01894230|183225876|EQUIVALENCE|MPR calculated from baseline to last patient follow-up (3 months or 8 months)|Slope|-0.053|STANDARD_ERROR_OF_MEAN|0.091||0.6692|TWO_SIDED||||||Regression, Linear|||||||0.6692
91666232|NCT01894230|183225877|EQUIVALENCE|Baseline to Month 3|Odds Ratio (OR)|2.025||||0.0371|TWO_SIDED|95.0|1.043|3.929|||Regression, Logistic|||||3.929|1.043|0.0371
91666233|NCT01894230|183225877|EQUIVALENCE|Month 3 to Month 8|Odds Ratio (OR)|1.115||||0.8815|TWO_SIDED|95.0|0.265|4.687|||Regression, Logistic|||||4.687|0.265|0.8815
91666234|NCT01894230|183225878|EQUIVALENCE|Month 3|Slope|0.143|STANDARD_ERROR_OF_MEAN|0.27||0.5965|TWO_SIDED||||||Regression, Linear|||||||0.5965
91666235|NCT01894230|183225878|EQUIVALENCE|Month 8|Slope|0.258|STANDARD_ERROR_OF_MEAN|0.346||0.4579|TWO_SIDED||||||Regression, Linear|||||||0.4579
91666236|NCT01894230|183225879|EQUIVALENCE|Month 3|Slope|0.098|STANDARD_ERROR_OF_MEAN|0.163||0.5477|TWO_SIDED||||||Regression, Linear|||||||0.5477
91631561|NCT02735044|183156408|SUPERIORITY|Superiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% CI for the difference between treatment groups was \<0 (zero).||||||0.965||||||Threshold for significance at 0.025 level.|ANCOVA|||A step-wise closed testing approach was used to control the type I error. Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||||0.965
91631562|NCT00412113|183156423|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.03|||<|0.001||95.0|9.14|39.63||There was only one primary endpoint and the p-value was not adjusted for comparison.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(\< 140/90 mmHg) and LDL goal (\< 100mg/dL) at Week 6.~With \~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP \<140/90 mmHg and LDL \<100 mg/dL and using a chi-square test with 0.05 two-sided significance level."||39.63|9.14|<0.001
91631563|NCT00412113|183156424|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|31.39|||<|0.001||95.0|12.61|78.09||No adjustment for p-value for secondary analysis|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<100 mg/dL) at Week 4.||78.09|12.61|<0.001
91631564|NCT00412113|183156425|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.2|||<|0.001||95.0|2.93|9.24||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 4.||9.24|2.93|<0.001
91631565|NCT00412113|183156426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.14|||<|0.001||95.0|2.89|9.11||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 6.||9.11|2.89|<0.001
91631566|NCT00412113|183156427|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|65.51|||<|0.001||95.0|27.1|158.34||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (\<100mg/DL) at Week 4.||158.34|27.10|<0.001
91631567|NCT00412113|183156428|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|42.04|||<|0.001||95.0|19.42|90.99||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (\<100mg/DL) at Week 6.||90.99|19.42|<0.001
91631568|NCT00412113|183156429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.785||95.0|0.6|1.98||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg)at Week 4||1.98|0.60|0.785
91631569|NCT00412113|183156430|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.171||95.0|0.83|2.88||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg) at Week 6.||2.88|0.83|0.171
91631570|NCT00412113|183156431|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.76||||0.585||95.0|-1.97|3.48||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.||3.48|-1.97|0.585
91631571|NCT00412113|183156432|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0|||>|0.999||95.0|-2.01|2.01||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.||2.01|-2.01|> 0.999
91666237|NCT01894230|183225879|EQUIVALENCE|Month 8|Slope|0.298|STANDARD_ERROR_OF_MEAN|0.145||0.0429|TWO_SIDED||||||Regression, Linear|||||||0.0429
91631572|NCT00412113|183156433|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.363||95.0|-2.83|1.04|||ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.||1.04|-2.83|0.363
91631573|NCT00412113|183156434|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-3.25||||0.02||95.0|-5.99|-0.51||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.||-0.51|-5.99|0.020
91631574|NCT00412113|183156435|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.87||||0.351||95.0|-2.71|0.97||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.||0.97|-2.71|0.351
91631575|NCT00412113|183156436|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.922||95.0|-1.91|2.11||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.||2.11|-1.91|0.922
91631576|NCT00412113|183156437|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-49.3|||<|0.001||95.0|-54.68|-43.91||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.||-43.91|-54.68|<0.001
91666238|NCT01894230|183225880|EQUIVALENCE|Month 3|Slope|-0.211|STANDARD_ERROR_OF_MEAN|0.881||0.8106|TWO_SIDED||||||Regression, Linear|||||||0.8106
91666239|NCT01894230|183225880|EQUIVALENCE|Month 8|Slope|0.646|STANDARD_ERROR_OF_MEAN|1.009||0.5233|TWO_SIDED||||||Regression, Linear|||||||0.5233
91666240|NCT01894230|183225881|EQUIVALENCE|Month 3|Slope|-0.6001|STANDARD_ERROR_OF_MEAN|1.472||0.6841|TWO_SIDED||||||Regression, Linear|||||||0.6841
91666241|NCT01894230|183225881|EQUIVALENCE|Month 8|Slope|-0.771|STANDARD_ERROR_OF_MEAN|1.781||0.6658|TWO_SIDED||||||Regression, Linear|||||||0.6658
91666242|NCT01894230|183225882|EQUIVALENCE|Month 8|Odds Ratio (OR)|1.085||||0.8384|TWO_SIDED|95.0|0.495|2.38|||Regression, Logistic|Ordinal Logistic||||2.380|0.495|0.8384
91666243|NCT01894230|183225883|EQUIVALENCE|Month 3 BMQ Necessity|Slope|1.163|STANDARD_ERROR_OF_MEAN|0.584||0.0486|TWO_SIDED||||||Regression, Linear|||||||0.0486
91631577|NCT00412113|183156438|SUPERIORITY_OR_OTHER_LEGACY||difference in LS Means|-0.3||||0.739||95.0|-2.07|1.47||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.||1.47|-2.07|0.739
91631578|NCT00412113|183156439|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-57.9|||<|0.001||95.0|-64.02|51.81||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.||51.81|-64.02|<0.001
91631579|NCT00412113|183156440|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-47.27|||<|0.001||95.0|-63.37|-31.16||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.||-31.16|-63.37|<0.001
91666244|NCT01894230|183225883|EQUIVALENCE|Month 8, BMQ Necessity|Slope|0.248|STANDARD_ERROR_OF_MEAN|0.67||0.7235|TWO_SIDED||||||Regression, Linear|||||||0.7235
91666245|NCT01894230|183225883|EQUIVALENCE|Month 3, BMQ Concerns|Slope|-0.862|STANDARD_ERROR_OF_MEAN|0.686||0.2113|TWO_SIDED||||||Regression, Linear|||||||0.2113
91666246|NCT01894230|183225883|EQUIVALENCE|Month 8, BMQ Concerns|Slope|-1.0083|STANDARD_ERROR_OF_MEAN|0.737||0.1739|TWO_SIDED||||||Regression, Linear|||||||0.1739
91666247|NCT00642993|183225897|SUPERIORITY_OR_OTHER||Difference in means|0.41||||0.187|TWO_SIDED|95.0|-0.2|1.03|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||1.03|-0.20|0.187
91666248|NCT00642993|183225898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.14|TWO_SIDED|95.0|0.28|1.2|||Cochran-Mantel-Haenszel|The P-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||1.20|0.28|0.140
91666249|NCT00642993|183225899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.515|TWO_SIDED|95.0|0.24|9.93|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||9.93|0.24|0.515
91666250|NCT00642993|183225900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.543|TWO_SIDED|95.0|-1.2|0.63|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.63|-1.20|0.543
91666251|NCT00642993|183225901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.231|TWO_SIDED|95.0|-0.09|0.35|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.35|-0.09|0.231
91666252|NCT02664415|183225903|SUPERIORITY|||||||1|||||||Fisher Exact|This is to confirm that the p-value from Fisher's Exact test was 1.000.||||||1.000
91631580|NCT00412113|183156441|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-51.21|||<|0.001||95.0|-56.88|-45.55||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.||-45.55|-56.88|<0.001
91666253|NCT02664415|183225904|SUPERIORITY|||||||0.051|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 20 copies/mL between arms.||||0.051
91666254|NCT02664415|183225904|SUPERIORITY|||||||0.01|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 1000 copies/mL between arms.||||0.01
91631581|NCT00412113|183156442|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.02||||0.329||95.0|-3.07|1.03||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.||1.03|-3.07|0.329
91666255|NCT02664415|183225905|SUPERIORITY|||||||0.027||||||This is a p-value, comparing HIV-1 RNA levels at first detection between arms.|Wilcoxon (Mann-Whitney)|||||||0.027
91666256|NCT02664415|183225905|SUPERIORITY|||||||0.588||||||This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.|Wilcoxon (Mann-Whitney)|||||||0.588
91631582|NCT00412113|183156443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-62.07|||<|0.001||95.0|-68.49|-55.65||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.||-55.65|-68.49|<0.001
91631583|NCT00412113|183156444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-53.95|||<|0.001||95.0|-77.61|-30.29||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.||-30.29|-77.61|<0.001
91666257|NCT02664415|183225906|SUPERIORITY|||||||0.031|||||||Log Rank|||||||0.031
91666258|NCT02664415|183225908|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||0.693
91666259|NCT02664415|183225909|SUPERIORITY|||||||0.15||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.||||0.15
91666260|NCT02664415|183225909|SUPERIORITY|||||||0.04||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.||||0.04
91666261|NCT02664415|183225909|SUPERIORITY|||||||0.002||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.||||0.002
91666262|NCT02664415|183225909|SUPERIORITY|||||||0.22||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.||||0.22
91666263|NCT02664415|183225909|SUPERIORITY|||||||0.05|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.||||0.05
91666264|NCT02664415|183225909|SUPERIORITY|||||||0.22|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm||||0.22
91666265|NCT02664415|183225912|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at baseline ATI||||0.961
91666266|NCT02664415|183225912|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at ART resumption||||0.805
91666267|NCT02664415|183225912|SUPERIORITY|||||||0.221|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within VRC01 arm.||||0.221
91666268|NCT02664415|183225912|SUPERIORITY|||||||0.5|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within Placebo arm.||||0.500
91666269|NCT02664415|183225913|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups at baseline ATI.||||0.522
91666270|NCT02664415|183225913|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||A comparison between groups at ART resumption.||||0.961
91666271|NCT02664415|183225913|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within VRC01 group.||||0.002
91666272|NCT02664415|183225913|SUPERIORITY|||||||0.043|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within Placebo group.||||0.043
91666273|NCT02034513|183225914|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.94|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.||0.94|0.85|<0.0001
91666274|NCT02034513|183225915|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.56|0.73|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period.||0.73|0.56|<0.0001
91631584|NCT00412113|183156445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.4|||<|0.001||95.0|-3.1|-1.7||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.||-1.7|-3.1|<0.001
91631585|NCT00412113|183156446|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.8|||<|0.001||95.0|-3.5|-2.1||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.||-2.1|-3.5|<0.001
91631586|NCT01201967|183156447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.68||||0.002|TWO_SIDED|95.0|2.14|9.22|||Mixed Models Analysis|||||9.22|2.14|0.002
91631587|NCT01201967|183156448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.045|TWO_SIDED|95.0|-4.06|-0.05|||Mixed Models Analysis|||||-0.05|-4.06|0.045
91666275|NCT02034513|183225916|SUPERIORITY_OR_OTHER|||||||0.0016||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in both the maintenance periods. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period.||||0.0016
91631588|NCT01201967|183156449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.55|TWO_SIDED|95.0|-0.93|1.76|||Mixed Models Analysis|||||1.76|-0.93|0.55
91631589|NCT01201967|183156450|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.9|||Chi-squared|||||24.9|5.20|<0.001
91631590|NCT01201967|183156451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.28|TWO_SIDED|95.0|-0.51|1.76|||Mixed Models Analysis|||||1.76|-0.51|0.28
91631591|NCT01201967|183156452|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.83|TWO_SIDED|95.0|0.63|1.46|||Chi-squared|||||1.46|0.63|0.83
91631592|NCT01201967|183156453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.029|TWO_SIDED|95.0|0.012|0.22|||Mixed Models Analysis|||||0.22|0.012|0.029
91631593|NCT01201967|183156454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59||||0.005|TWO_SIDED|95.0|1.71|9.46|||Mixed Models Analysis|||||9.46|1.71|0.005
91631594|NCT01201967|183156455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.11|TWO_SIDED|95.0|-0.54|5.14|||Mixed Models Analysis|||||5.14|-0.54|0.11
91666276|NCT02034513|183225918|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 437 (n=220 for IDeg and n=217 for IGlar).|Treatment contrast|0.03|||||TWO_SIDED|95.0|-0.1|0.15||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before testing the primary endpoint, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as a prerequisite for testing the primary endpoint. Analysis was based on mixed model for repeated measurement (MMRM); treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates."||0.15|-0.10|
91631595|NCT00740116|183156463|SUPERIORITY|||||||0.03||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.03
91631596|NCT00740116|183156464|SUPERIORITY|||||||0.07||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.07
91631597|NCT00740116|183156465|SUPERIORITY||Odds Ratio (OR)|0.44||||0.46|ONE_SIDED|95.0||0.97||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||0.97||0.46
91631598|NCT00740116|183156466|SUPERIORITY|||||||0.46||||||p\< 0.05 for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.46
91631599|NCT00740116|183156467|SUPERIORITY||Odds Ratio (OR)|0.36||||0.22|TWO_SIDED|95.0|0.05|2.72||Statistical significance threshold p-value \< 0.05|Fisher Exact|||||2.72|0.05|0.22
91631600|NCT01111331|183156480|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean ratio|100.89|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|96.86|105.1|||ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by empa||105.10|96.86|
91714313|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|8.1||0.1443||95.0|-27.8|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-27.8|0.1443
91714314|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|7.96||0.2946||95.0|-24.0|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-24.0|0.2946
91792429|NCT02278341|183462592|SUPERIORITY||Hazard Ratio (HR)|0.368|||<|0.001|TWO_SIDED|95.0|0.291|0.465|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.465|0.291|<0.001
91483653|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.0595|TWO_SIDED|95.0|-0.004|0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 84|||0.188|-0.004|0.0595
91631601|NCT01111331|183156481|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|100.64|STANDARD_DEVIATION|19.9||0.0021|TWO_SIDED|90.0|89.79|112.8||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by empa||112.80|89.79|0.0021
91631602|NCT01111331|183156482|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.49|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|95.29|101.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||101.80|95.29|
91631603|NCT01111331|183156483|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|12.4||0.0001|TWO_SIDED|90.0|91.12|105.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||105.15|91.12|0.0001
91631604|NCT01111331|183156484|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|95.88|STANDARD_DEVIATION|4.5|||TWO_SIDED|90.0|93.4|98.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.43|93.40|
91631605|NCT01111331|183156485|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.88|STANDARD_DEVIATION|12.7||0.0001|TWO_SIDED|90.0|91.84|106.47||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||106.47|91.84|0.0001
91483654|NCT02869438|182840806|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.1377|TWO_SIDED|95.0|-0.02|0.147|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||0.147|-0.02|0.1377
91631606|NCT01111331|183156493|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.9|STANDARD_DEVIATION|5.3|||TWO_SIDED|90.0|95.89|102.0|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||102.00|95.89|
91631607|NCT01111331|183156500|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|96.09|STANDARD_DEVIATION|4.4|||TWO_SIDED|90.0|93.64|98.6|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.60|93.64|
91631608|NCT01111331|183156507|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.04|0.73|
91631609|NCT01111331|183156508|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.79|
91666277|NCT02034513|183225918|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 410 (n=202 for IDeg and n=208 for IGlar).|Treatment contrast|0.11|||||TWO_SIDED|95.0|0.0|0.23||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was based on MMRM; treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates"||0.23|-0.00|
91666278|NCT02218541|183225959|OTHER|||||||1||||||threshold for significance will be p-value \<0.05|Fisher Exact|||||||1.00
91666279|NCT02218541|183225960|OTHER|||||||0.039||||||This statistical analysis applies to Yes bleeding|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||0.039
91792430|NCT02278341|183462593|SUPERIORITY||LSM Difference|-35.1|||<|0.001|TWO_SIDED|95.0|-51.8|-18.4|||ANCOVA|||Weeks 37-52 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-18.4|-51.8|<0.001
91714315|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|8.22||0.3686||95.0|-23.6|8.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.8|-23.6|0.3686
91483655|NCT02869438|182840807|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1604|TWO_SIDED|95.0|0.85|2.58|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||2.58|0.85|0.1604
91714316|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|8.02||0.6079||95.0|-19.9|11.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-19.9|0.6079
91483656|NCT02869438|182840807|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.76|2.19|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||2.19|0.76|0.3400
91525736|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0282|TWO_SIDED|95.0|1.22|33.89|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||33.89|1.22|0.0282
91631610|NCT01111331|183156509|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.99|||||TWO_SIDED|95.0|0.67|1.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.48|0.67|
91631611|NCT01111331|183156510|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.9|||||TWO_SIDED|95.0|0.79|1.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.02|0.79|
91631612|NCT01111331|183156511|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.95|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.95|0.64|
91631613|NCT01111331|183156512|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.84|
91631614|NCT01111331|183156513|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.97|||||TWO_SIDED|95.0|0.68|1.4|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.40|0.68|
91792431|NCT02278341|183462593|SUPERIORITY||LSM Difference|-48.7|||<|0.001|TWO_SIDED|95.0|-70.3|-27.0|||ANCOVA|||Weeks 53-104 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-27.0|-70.3|<0.001
91483657|NCT02869438|182840807|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0924|TWO_SIDED|95.0|0.93|2.7|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||2.70|0.93|0.0924
91631615|NCT01111331|183156514|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.47|1.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.51|0.47|
91631616|NCT03650387|183156542|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
91483658|NCT02869438|182840807|SUPERIORITY||Odds Ratio (OR)|1.57||||0.1052|TWO_SIDED|95.0|0.91|2.71|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||2.71|0.91|0.1052
91483659|NCT02869438|182840807|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3271|TWO_SIDED|95.0|0.77|2.21|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||2.21|0.77|0.3271
91631617|NCT03650387|183156543|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
91631618|NCT03650387|183156544|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
91631619|NCT02903966|183156574|OTHER||Least Square Mean Difference|-0.18|||||TWO_SIDED|95.0|-1.23|0.87|||||Analysis performed using a Mixed Models Repeated Measures (MMRM) model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||0.87|-1.23|
91483660|NCT02869438|182840807|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3017|TWO_SIDED|95.0|0.77|2.29|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||2.29|0.77|0.3017
91483661|NCT02869438|182840808|SUPERIORITY||Mean Difference (Final Values)|-0.293||||0.0024|TWO_SIDED|95.0|-0.481|-0.105|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 14|||-0.105|-0.481|0.0024
91525737|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.257||||0.0042|TWO_SIDED|95.0|2.36|98.42|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.42|2.36|0.0042
91631620|NCT02903966|183156575|OTHER||Least Square Mean Difference|0.02|||||TWO_SIDED|95.0|-1.18|1.22|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||1.22|-1.18|
91631621|NCT02903966|183156576|OTHER||Least Square Mean Difference|-0.05|||||TWO_SIDED|95.0|-4.11|4.02|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.02|-4.11|
91631622|NCT02903966|183156576|OTHER||Least Square Mean Difference|-3.17|||||TWO_SIDED|95.0|-5.99|-0.35|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||-0.35|-5.99|
91631623|NCT02903966|183156576|OTHER||Least Square Mean Difference|-1.69|||||TWO_SIDED|95.0|-6.26|2.88|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||2.88|-6.26|
91631624|NCT02903966|183156577|OTHER||Least Square Mean Difference|0.29|||||TWO_SIDED|95.0|-4.01|4.59|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.59|-4.01|
91631625|NCT02903966|183156577|OTHER||Least Square Mean Difference|0.11|||||TWO_SIDED|95.0|-3.64|3.85|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||3.85|-3.64|
91631626|NCT02903966|183156577|OTHER||Least Square Mean Difference|1.12|||||TWO_SIDED|95.0|-2.87|5.1|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||5.10|-2.87|
91631627|NCT02903966|183156578|OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.27|1.8|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.80|0.27|
91631628|NCT02903966|183156578|OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.2|1.0|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.00|0.20|
91631629|NCT02903966|183156578|OTHER||Ratio|0.23|||||TWO_SIDED|95.0|0.09|0.62|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.62|0.09|
91631630|NCT02903966|183156579|OTHER||Ratio|0.49|||||TWO_SIDED|95.0|0.25|0.97|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.97|0.25|
91631631|NCT02903966|183156579|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.2|1.57|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.57|0.20|
91483662|NCT02869438|182840808|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.0002|TWO_SIDED|95.0|-0.609|-0.195|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 28|||-0.195|-0.609|0.0002
91483663|NCT02869438|182840808|SUPERIORITY||Mean Difference (Final Values)|-0.312||||0.0117|TWO_SIDED|95.0|-0.554|-0.07|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 56|||-0.07|-0.554|0.0117
91483664|NCT02869438|182840808|SUPERIORITY||Mean Difference (Final Values)|-0.472||||0.0004|TWO_SIDED|95.0|-0.731|-0.213|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 84|||-0.213|-0.731|0.0004
91631632|NCT02903966|183156579|OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.31|2.18|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||2.18|0.31|
91631633|NCT02903966|183156580|OTHER||Least Square Mean Difference|0.01|||||TWO_SIDED|95.0|-2.05|2.07|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.07|-2.05|
91631634|NCT02903966|183156581|OTHER||Least Square Mean Difference|0.08|||||TWO_SIDED|95.0|-2.11|2.27|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.27|-2.11|
91631635|NCT02903966|183156582|OTHER||Least Square Mean Difference|-0.76|||||TWO_SIDED|95.0|-5.29|3.77|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||3.77|-5.29|
91666280|NCT02218541|183225961|EQUIVALENCE|No power calculation was done as this was a pilot study.||||||1||||||This statistical analysis applies to Yes Provisional Crown fit|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||1.0
91666281|NCT00856349|183225962|SUPERIORITY_OR_OTHER||Increase in % on target (LIA)|13.6|||<|0.0001|||||||McNemar|||LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.||||<0.0001
91483665|NCT02869438|182840808|SUPERIORITY||Mean Difference (Final Values)|-0.395||||0.0002|TWO_SIDED|95.0|-0.603|-0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-0.188|-0.603|0.0002
91483666|NCT02869438|182840809|SUPERIORITY||Mean Difference (Final Values)|-7.229||||0.0001|TWO_SIDED|95.0|-10.832|-3.626|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 28|||-3.626|-10.832|0.0001
91483667|NCT02869438|182840809|SUPERIORITY||Mean Difference (Final Values)|-5.942||||0.0115|TWO_SIDED|95.0|-10.538|-1.346|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 56|||-1.346|-10.538|0.0115
91631636|NCT02903966|183156583|OTHER||Least Square Mean Difference|-0.8|||||TWO_SIDED|95.0|-5.68|4.08|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||4.08|-5.68|
91631637|NCT02903966|183156588|OTHER||Least Square Mean Difference|-0.36|||||TWO_SIDED|95.0|-1.58|0.86|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||0.86|-1.58|
91631638|NCT02903966|183156588|OTHER||Least Square Mean Difference|-0.1|||||TWO_SIDED|95.0|-1.29|1.08|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.08|-1.29|
91631639|NCT02903966|183156588|OTHER||Least Square Mean Difference|-0.34|||||TWO_SIDED|95.0|-1.72|1.04|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.04|-1.72|
91631640|NCT02903966|183156589|OTHER||Least Square Mean Difference|-0.06|||||TWO_SIDED|95.0|-1.87|1.75|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.75|-1.87|
91631641|NCT01320033|183156606|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.006|TWO_SIDED|95.0|-6.1|-1.1|||ANCOVA|||||-1.1|-6.1|0.006
91631642|NCT01320033|183156606|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.024|TWO_SIDED|95.0|-5.4|-0.4|||ANCOVA|||||-0.4|-5.4|0.024
91666282|NCT00856349|183225962|SUPERIORITY_OR_OTHER||Increase in % on target (SVT Limit)|6.8|||<|0.0001|||||||McNemar|||SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.||||<0.0001
91666283|NCT00856349|183225962|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID PP)|9.0|||<|0.0001|||||||McNemar|||VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.||||<0.0001
91666284|NCT00856349|183225962|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID SP)|3.5||||0.0116|||||||McNemar|||VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.||||0.0116
91666285|NCT00856349|183225962|SUPERIORITY_OR_OTHER||Increase in % on target (Wavelet)|9.5|||<|0.0001|||||||McNemar|||Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.||||<0.0001
91483668|NCT02869438|182840809|SUPERIORITY||Mean Difference (Final Values)|-8.599||||0.0004|TWO_SIDED|95.0|-13.3|-3.898|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 84|||-3.898|-13.3|0.0004
91631643|NCT01320033|183156606|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.595|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.595
91631644|NCT02425891|183156613|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0025|TWO_SIDED|95.0|0.69|0.92|||Log Rank|||||0.92|0.69|0.0025
91631645|NCT02425891|183156614|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Log Rank|||||0.78|0.49|<.0001
91631646|NCT02425891|183156615|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.87||||0.077|TWO_SIDED|95.0|0.75|1.02|||Log Rank|||||1.02|0.75|0.0770
91631647|NCT02425891|183156616|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.67||||0.0016|TWO_SIDED|95.0|0.53|0.86|||Log Rank|||||0.86|0.53|0.0016
91631648|NCT02425891|183156617|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|10.12||||0.0021|TWO_SIDED|95.0|3.4|16.84|||Cochran-Mantel-Haenszel|||||16.84|3.40|0.0021
91631649|NCT02425891|183156618|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|16.3||||0.0016|TWO_SIDED|95.0|5.67|26.92|||Cochran-Mantel-Haenszel|||||26.92|5.67|0.0016
91631650|NCT02425891|183156619|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.78||||0.0285|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0285
91631651|NCT02425891|183156620|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0047|TWO_SIDED|95.0|0.43|0.86|||Log Rank|||||0.86|0.43|0.0047
91631652|NCT02425891|183156621|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8078|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|0.81|0.8078
91631653|NCT02425891|183156622|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8879|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.8879
91631654|NCT02943577|183156638|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.2398|TWO_SIDED|95.0|-2.7|0.68|||Mixed Model Repeated Measures (MMRM)|||||0.68|-2.70|0.2398
91631655|NCT02943577|183156639|SUPERIORITY||Least Squares Mean Difference|0.4||||0.5522|TWO_SIDED|95.0|-0.95|1.77|||Mixed Model Repeated Measures (MMRM)|||||1.77|-0.95|0.5522
91631656|NCT02943577|183156640|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9901|TWO_SIDED|95.0|-2.01|1.99|||Mixed Model Repeated Measures (MMRM)|||||1.99|-2.01|0.9901
91631657|NCT02943577|183156641|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5563|TWO_SIDED|95.0|-1.17|2.17|||Mixed Model Repeated Measures (MMRM)|||||2.17|-1.17|0.5563
91631658|NCT01355224|183156642|SUPERIORITY_OR_OTHER|||||||0.015|||||||Regression, Linear|Adjusted for age, gender, BMI, baseline intention.||||||.0150
91631659|NCT01355224|183156643|SUPERIORITY_OR_OTHER|||||||0.0365|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0365
91631660|NCT01355224|183156644|SUPERIORITY_OR_OTHER|||||||0.0622|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0622
91631661|NCT03991936|183156646|SUPERIORITY||Mean Difference (Net)|-2.635|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided|||The null hypothesis was that the change from baseline to 24 weeks in the Nail Psoriasis Severity Index (NAPSI) for the triamcinolone acetonide groups: 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10 mg/mL would be no different than the change from baseline to 24 weeks for the placebo group.||||<0.001
91631662|NCT03502941|183156666|SUPERIORITY||||||<|0.05||||||P value was calculated.|t-test, 2 sided|||||||<0.05
91666286|NCT00856349|183225962|SUPERIORITY_OR_OTHER||Increase in % on target (PR Logic)|3.2|||<|0.0001|||||||McNemar|||PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.||||<0.0001
91692036|NCT02174627|183278566|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.47|0.52|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.52|0.47|<0.001
91483669|NCT02869438|182840809|SUPERIORITY||Mean Difference (Final Values)|-7.257||||0.0003|TWO_SIDED|95.0|-11.133|-3.38|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-3.38|-11.133|0.0003
91483670|NCT02869438|182840810|SUPERIORITY||Mean Difference (Final Values)|5.414||||0.2825|TWO_SIDED|95.0|-4.492|15.321|||Mixed Models Analysis|Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.||||15.321|-4.492|0.2825
91483671|NCT02869438|182840820|SUPERIORITY||Mean Difference (Final Values)|-0.365||||0.012|TWO_SIDED|95.0|-0.649|-0.081|||Mixed Models Analysis|Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.|For Day 84|||-0.081|-0.649|0.0120
91483672|NCT02869438|182840821|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0018|TWO_SIDED|95.0|1.5|5.88|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.88|1.50|0.0018
91483673|NCT02869438|182840822|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0107|TWO_SIDED|95.0|1.24|5.09|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.09|1.24|0.0107
91525738|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.967||||0.5164|TWO_SIDED|95.0|0.11|79.24|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||79.24|0.11|0.5164
91631663|NCT03502941|183156667|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91525739|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.36||||0.0445|TWO_SIDED|95.0|1.08|422.94|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||422.94|1.08|0.0445
91525740|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.157||||0.0223|TWO_SIDED|95.0|1.35|49.37|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||49.37|1.35|0.0223
91631664|NCT00808028|183156674|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
91631665|NCT00808028|183156674|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0007
91666287|NCT03809000|183225971|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0671|TWO_SIDED|80.0|0.61|0.96|||Log Rank|One-sided significance level = 0.10|Reference level = standard ADT|After protocol amendments, the 3-year PFS rate of the standard arm was expected to be 24%. Assuming a hazard ratio of 0.65 (treatment/control) results in a hypothesized 3-year PFS rate of 39.5% on the enhanced ADT arm. A one-sided log-rank test with alpha=0.10 at 80% statistical power was calculated to require 101 events from 170 patients, taking into account expected accrual rate and follow-up time.||0.96|0.61|0.0671
91666288|NCT03809000|183225972|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.116|TWO_SIDED|95.0|0.53|1.07|||Gray's||Reference level = SRT + Standard ADT|||1.07|0.53|0.1160
91525741|NCT01350141|182926925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.587||||0.007|TWO_SIDED|95.0|2.04|90.4|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||90.40|2.04|0.0070
91525742|NCT01350141|182926926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.647||||0.2928|TWO_SIDED|95.0|0.22|142.04|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||142.04|0.22|0.2928
91525743|NCT01350141|182926926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|591.174||||0.0014|TWO_SIDED|95.0|11.68|29922.99|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||29922.99|11.68|0.0014
91631666|NCT00808028|183156674|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
91631667|NCT00808028|183156674|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
91631668|NCT00808028|183156674|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
91631669|NCT00808028|183156674|SUPERIORITY_OR_OTHER|||||||0.0392|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0392
91631670|NCT00808028|183156674|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0225
91631671|NCT00808028|183156674|SUPERIORITY_OR_OTHER|||||||0.0244|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0244
91666289|NCT03809000|183225973|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.1618|TWO_SIDED|95.0|0.5|1.12|||Gray's||Reference level = SRT + Standard ADT|||1.12|0.50|0.1618
91666290|NCT03809000|183225978|SUPERIORITY|||||||0.7184|||||||t-test, 2 sided|||||||0.7184
91666291|NCT03809000|183225979|SUPERIORITY|||||||0.5934|||||||t-test, 2 sided|||||||0.5934
91631672|NCT00808028|183156675|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
91631673|NCT00808028|183156675|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0004
91631674|NCT00808028|183156675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
91631675|NCT00808028|183156675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
91666292|NCT03809000|183225980|SUPERIORITY|||||||0.7129|||||||t-test, 2 sided|||||||0.7129
91666293|NCT03809000|183225981|SUPERIORITY|||||||0.006258|||||||t-test, 2 sided|||||||0.006258
91666294|NCT03809000|183225982|SUPERIORITY|||||||0.0263|||||||t-test, 2 sided|||||||0.0263
91666295|NCT03809000|183225983|SUPERIORITY|||||||0.4599|||||||t-test, 2 sided|||||||0.4599
91666296|NCT03809000|183225985|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3138|TWO_SIDED|95.0|0.62|4.41|||Regression, Logistic||Reference level = SRT + Standard ADT|||4.41|0.62|0.3138
91666297|NCT03809000|183225986|SUPERIORITY|||||||0.3889|||||||Chi-squared|||||||0.3889
91666298|NCT03809000|183225987|SUPERIORITY|||||||0.0461|||||||t-test, 2 sided|||Hot Flashes Frequency||||0.0461
91666299|NCT03809000|183225987|SUPERIORITY|||||||0.0181|||||||t-test, 2 sided|||Hot Flashes Severity||||0.0181
91666300|NCT03809000|183225988|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.1|TWO_SIDED|80.0|0.42|0.91||one-sided p-value|Log Rank|||||0.91|0.42|0.10
91666301|NCT02312154|183226151|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
91631676|NCT00808028|183156675|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
91631677|NCT00808028|183156675|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0036
91631678|NCT00808028|183156675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
91631679|NCT00808028|183156675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
91631680|NCT01599585|183156693|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.4|||||TWO_SIDED|90.0|0.12|0.68||||||||.68|.12|
91631681|NCT01599585|183156705|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.47|||||TWO_SIDED|90.0|0.16|0.78||||||||.78|.16|
91631682|NCT05085275|183156720|NON_INFERIORITY|The study planned to enroll 400 patients (200 patients in each treatment arm) to achieve 90% power to detect a hazard ratio (HR) of 0.60 for the primary composite endpoint, with differences between treatment groups assessed using a 2-sided alpha of \<0.05|Hazard Ratio (HR)|0.73||||0.1602|TWO_SIDED|95.0|0.46|1.14|||Regression, Cox|||||1.14|0.46|.1602
91631683|NCT05085275|183156722|OTHER||Hazard Ratio (HR)|0.78|STANDARD_ERROR_OF_MEAN|0.2392||0.3|||||||Regression, Cox|||||||.30
91631684|NCT05085275|183156723|OTHER||Hazard Ratio (HR)|0.35|STANDARD_ERROR_OF_MEAN|0.8295||0.17|||||||Regression, Cox|||||||0.17
91666302|NCT02312154|183226152|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
91666303|NCT02312154|183226153|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
91666304|NCT02312154|183226154|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
91631685|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-0.755|-0.386||||||||-0.386|-0.755|
91631686|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.762|||||TWO_SIDED|95.0|-0.925|-0.598||||||||-0.598|-0.925|
91666305|NCT02312154|183226155|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
91666306|NCT02312154|183226156|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
91483674|NCT05323656|182840826|SUPERIORITY||LS Mean Difference|5.05|STANDARD_ERROR_OF_MEAN|13.077||0.7008|TWO_SIDED|80.0|-11.98|22.0|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group|Null hypothesis: the mean best percentage change in the tumour size between the treatment groups are the same. With 25 patients per treatment group, using a 2-sided t-test, there will be 85% power to detect a 20% mean difference between the treatment groups in best percentage change in tumour size, with an estimated standard deviation of 30% and a 2 sided alpha of 20%.||22.0|-11.98|0.7008
91483675|NCT05323656|182840827|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.1023|TWO_SIDED|80.0|0.38|0.89|||Regression, Cox|||Null hypothesis: The risk for progression, as defined by RECIST v1.1, is the same between treatment groups. If the true hazard ratio is 0.5, approximately 38 progression events as defined by RECIST v1.1 will be required to have \> 80% power to demonstrate a statistically significant difference in PFS with 2-sided p\<0.2||0.89|0.38|.1023
91483676|NCT05323656|182840828|SUPERIORITY||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|8.89||0.2986|TWO_SIDED|80.0|-2.3|21.3||a priori threshold for significance (0.2) not met.|ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CAF levels does not differ between treatment groups. ANCOVA model is on postbaseline CAFs level with a fixed factor for treatment and a covariate for baseline.||21.3|-2.3|0.2986
91483677|NCT05323656|182840829|SUPERIORITY||LS Mean Difference|6.83|STANDARD_ERROR_OF_MEAN|12.48||0.5918|TWO_SIDED|80.0|-9.86|23.52|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CD8+ TILs does not differ between treatment groups. ANCOVA model is on postbaseline CD8+ TILs level with a fixed factor for treatment and a covariate for baseline.||23.52|-9.86|0.5918
91666307|NCT02052895|183226163|SUPERIORITY_OR_OTHER||Difference of ROC-AUC|0.0317||||0.3924|TWO_SIDED|95.0|-0.0409|0.1043|||Regression, Logistic|||||0.1043|-0.0409|0.3924
91666308|NCT01694563|183226209|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.||||0.05
91666309|NCT01694563|183226210|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.||||
91666310|NCT01694563|183226210|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.||||
91666311|NCT01694563|183226210|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0||||||||Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.|90% confidence interval using the Clopper-Pearson method.|||
91525744|NCT01350141|182926926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.468||||0.2339|TWO_SIDED|95.0|0.45|26.88|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||26.88|0.45|0.2339
91666312|NCT01026402|183226211|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|50.0|||||||||||||50mg twice daily continuous dosing 20 evaluable patients|||||
91666313|NCT01026402|183226211|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|100.0|||||||||||||100mg once daily continuous dosing 16 evaluable patients|||||
91666314|NCT01026402|183226211|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|125.0|||||||||||||125mg twice daily intermittent dosing (2 days on, 5 days off) 29 evaluable patients|||||
91631687|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|||||TWO_SIDED|95.0|-0.987|-0.665||||||||-0.665|-0.987|
91666315|NCT00836758|183226227|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
91631688|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.887|||||TWO_SIDED|95.0|-1.035|-0.739||||||||-0.739|-1.035|
91631689|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|||||TWO_SIDED|95.0|-0.57|-0.132||||||||-0.132|-0.570|
91631690|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.542|||||TWO_SIDED|95.0|-0.743|-0.342||||||||-0.342|-0.743|
91631691|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.607|||||TWO_SIDED|95.0|-0.808|-0.406||||||||-0.406|-0.808|
91631692|NCT01263470|183156732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|||||TWO_SIDED|95.0|-0.859|-0.475||||||||-0.475|-0.859|
91631693|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|||||TWO_SIDED|95.0|-0.213|-0.104||||||||-0.104|-0.213|
91631694|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|||||TWO_SIDED|95.0|-0.234|-0.114||||||||-0.114|-0.234|
91631695|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.219|-0.1||||||||-0.100|-0.219|
91631696|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|||||TWO_SIDED|95.0|-0.212|-0.095||||||||-0.095|-0.212|
91631697|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|||||TWO_SIDED|95.0|-0.116|-0.003||||||||-0.003|-0.116|
91631698|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|||||TWO_SIDED|95.0|-0.136|-0.014||||||||-0.014|-0.136|
91631699|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|||||TWO_SIDED|95.0|-0.121|0.0||||||||0.000|-0.121|
91631700|NCT01263470|183156733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|||||TWO_SIDED|95.0|-0.114|0.006||||||||0.006|-0.114|
91631701|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|||||TWO_SIDED|95.0|-0.419|-0.233||||||||-0.233|-0.419|
91631702|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.369|||||TWO_SIDED|95.0|-0.47|-0.268||||||||-0.268|-0.470|
91631703|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||||TWO_SIDED|95.0|-0.438|-0.241||||||||-0.241|-0.438|
91631704|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|||||TWO_SIDED|95.0|-0.485|-0.288||||||||-0.288|-0.485|
91631705|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|||||TWO_SIDED|95.0|-0.28|-0.076||||||||-0.076|-0.280|
91631706|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|||||TWO_SIDED|95.0|-0.329|-0.112||||||||-0.112|-0.329|
91631707|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.299|-0.085||||||||-0.085|-0.299|
91631708|NCT01263470|183156734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|||||TWO_SIDED|95.0|-0.346|-0.131||||||||-0.131|-0.346|
91525745|NCT01350141|182926926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|23.442||||0.0025|TWO_SIDED|95.0|3.03|181.11|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||181.11|3.03|0.0025
91525746|NCT01350141|182926926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.502||||0.1786|TWO_SIDED|95.0|0.38|192.32|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||192.32|0.38|0.1786
91631709|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.644|-0.356||||||||-0.356|-0.644|
91666316|NCT01945580|183226249|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 362 subjects (181 subjects per arm) are needed to detect non-inferiority of transvaginal biologic to native tissue repair, using a margin of 12.0%.|Adjusted Difference in Percentages|0.2|||||TWO_SIDED|90.0|-5.6|5.9|||||The propensity adjusted treatment difference of Xenform transvaginal mesh (TVM) minus NTR was estimated and missing data was handled using multiple imputation method.|||5.9|-5.6|
91631710|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.614|||||TWO_SIDED|95.0|-0.763|-0.464||||||||-0.464|-0.763|
91631711|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-0.804|-0.516||||||||-0.516|-0.804|
91631712|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.832|-0.559||||||||-0.559|-0.832|
91631713|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.325|||||TWO_SIDED|95.0|-0.494|-0.156||||||||-0.156|-0.494|
91631714|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.438|||||TWO_SIDED|95.0|-0.61|-0.267||||||||-0.267|-0.610|
91631715|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.485|||||TWO_SIDED|95.0|-0.654|-0.315||||||||-0.315|-0.654|
91631716|NCT01263470|183156735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||||TWO_SIDED|95.0|-0.683|-0.357||||||||-0.357|-0.683|
91631717|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
91631718|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
91631719|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
91631720|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
91631721|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
91631722|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
91631723|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
91631724|NCT01263470|183156736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
91631725|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
91631726|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
91631727|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
91631728|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
91631729|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
91631730|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
91631731|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
91631732|NCT01263470|183156737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
91631733|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.73|||||TWO_SIDED|95.0|-26.52|-8.94||||||||-8.94|-26.52|
91631734|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.22|||||TWO_SIDED|95.0|-32.07|-16.37||||||||-16.37|-32.07|
91631735|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.34|||||TWO_SIDED|95.0|-32.03|-16.65||||||||-16.65|-32.03|
91631736|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.28|||||TWO_SIDED|95.0|-37.04|-19.52||||||||-19.52|-37.04|
91631737|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||||TWO_SIDED|95.0|-17.28|0.18||||||||0.18|-17.28|
91631738|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.04|||||TWO_SIDED|95.0|-22.9|-7.18||||||||-7.18|-22.90|
91631739|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.16|||||TWO_SIDED|95.0|-22.9|-7.42||||||||-7.42|-22.90|
91631740|NCT01263470|183156738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||||TWO_SIDED|95.0|-27.8|-10.4||||||||-10.40|-27.80|
91792432|NCT02278341|183462603|SUPERIORITY||LSM Difference|0.521|||=|0.161|TWO_SIDED|95.0|-0.208|1.25||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, as continuous covariates.||1.250|-0.208|=0.161
91631741|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||||TWO_SIDED|95.0|-24.19|-5.64||||||||-5.64|-24.19|
91631742|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.17|||||TWO_SIDED|95.0|-27.86|-12.48||||||||-12.48|-27.86|
91631743|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.07|||||TWO_SIDED|95.0|-30.41|-15.73||||||||-15.73|-30.41|
91631744|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.17|||||TWO_SIDED|95.0|-36.05|-20.29||||||||-20.29|-36.05|
91631745|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-15.6|3.06||||||||3.06|-15.60|
91631746|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.52|||||TWO_SIDED|95.0|-19.41|-3.64||||||||-3.64|-19.41|
91483678|NCT05323656|182840830|SUPERIORITY||LS Mean Difference|10.84|STANDARD_ERROR_OF_MEAN|8.37||0.2135|TWO_SIDED|80.0|-0.34|22.02|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline number of regulatory T-cells in tumour tissue does not differ between treatment groups. ANCOVA model is on postbaseline number of regulatory T-cells in tumour tissue level with a fixed factor for treatment and a covariate for baseline.||22.02|-0.34|0.2135
91483679|NCT05323656|182840834|SUPERIORITY||Hazard Ratio (HR)|0.448|||||TWO_SIDED|80.0|0.24|0.85||||||No formal test of significance undertaken.||0.85|0.24|
91631747|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.42|||||TWO_SIDED|95.0|-22.04|-6.8||||||||-6.80|-22.04|
91631748|NCT01263470|183156739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.52|||||TWO_SIDED|95.0|-27.61|-11.43||||||||-11.43|-27.61|
91483680|NCT05323656|182840837|SUPERIORITY||Mean Difference (Final Values)|17.76|STANDARD_ERROR_OF_MEAN|9.4||0.0782|TWO_SIDED|80.0|5.17|30.36|||ANCOVA|The LS Mean difference is for the Setanaxib Group minus the Placebo Group.||Null Hypothesis: Mean difference in postbaseline PD-L1 combined positive score (CPS) does not differ between treatment groups. ANCOVA model is on postbaseline PD-L1 CPS with a fixed factor for treatment and a covariate for baseline. Threshold for statistical significance = 0.2.||30.36|5.17|0.0782
91483681|NCT05323656|182840838|OTHER||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.578||0.22|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.22
91631749|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.384|0.094||||||||0.094|-0.384|
91631750|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||||TWO_SIDED|95.0|-0.106|0.374||||||||0.374|-0.106|
91631751|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.103|0.39||||||||0.390|-0.103|
91631752|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.218|0.227||||||||0.227|-0.218|
91631753|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.241|0.245||||||||0.245|-0.241|
91631754|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|0.038|0.524||||||||0.524|0.038|
91631755|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|||||TWO_SIDED|95.0|0.041|0.54||||||||0.540|0.041|
91631756|NCT01263470|183156740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|||||TWO_SIDED|95.0|-0.077|0.38||||||||0.380|-0.077|
91483682|NCT05323656|182840838|OTHER||Mean Difference (Net)|-0.18|STANDARD_DEVIATION|0.395||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.20
91631757|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-0.245|0.156||||||||0.156|-0.245|
91631758|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|||||TWO_SIDED|95.0|-0.185|0.21||||||||0.210|-0.185|
91631759|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|||||TWO_SIDED|95.0|-0.053|0.369||||||||0.369|-0.053|
91631760|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.14|0.235||||||||0.235|-0.140|
91631761|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|||||TWO_SIDED|95.0|-0.097|0.341||||||||0.341|-0.097|
91631762|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|||||TWO_SIDED|95.0|-0.036|0.395||||||||0.395|-0.036|
91631763|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||||TWO_SIDED|95.0|0.097|0.553||||||||0.553|0.097|
91631764|NCT01263470|183156741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|||||TWO_SIDED|95.0|0.006|0.423||||||||0.423|0.006|
91631765|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.444|0.209||||||||0.209|-0.444|
91631766|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.362|0.162||||||||0.162|-0.362|
91631767|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|||||TWO_SIDED|95.0|-0.166|0.324||||||||0.324|-0.166|
91631768|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.355|0.121||||||||0.121|-0.355|
91631769|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.203|0.408||||||||0.408|-0.203|
91631770|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.124|0.364||||||||0.364|-0.124|
91631771|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|||||TWO_SIDED|95.0|0.071|0.526||||||||0.526|0.071|
91631772|NCT01263470|183156742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.118|0.322||||||||0.322|-0.118|
91631773|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.23|0.308||||||||0.308|-0.230|
91631774|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|-0.029|0.379||||||||0.379|-0.029|
91631775|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|||||TWO_SIDED|95.0|0.044|0.453||||||||0.453|0.044|
91631776|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||||TWO_SIDED|95.0|-0.035|0.407||||||||0.407|-0.035|
91631777|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-0.236|0.34||||||||0.340|-0.236|
91631778|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|||||TWO_SIDED|95.0|-0.044|0.421||||||||0.421|-0.044|
91631779|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|||||TWO_SIDED|95.0|0.026|0.496||||||||0.496|0.026|
91631780|NCT01263470|183156743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|||||TWO_SIDED|95.0|-0.049|0.448||||||||0.448|-0.049|
91666317|NCT01945580|183226250|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.10 (power 90%), 308 subjects (154 subjects per arm) are needed to detect non-inferiority with a margin of 11.6%.|Adjusted Difference in Percentages|2.0|||||TWO_SIDED|90.0|-0.8|4.7|||||The propensity score adjusted difference in SAE rate of Xenform transvaginal mesh (TVM) vs. NTR was estimated.|||4.7|-0.8|
91666318|NCT00073307|183226274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.146||95.0|0.74|1.04||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||1.04|0.74|0.146
91483683|NCT05323656|182840839|OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.069||0.037|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.037
91631781|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.85|||||TWO_SIDED|95.0|-38.75|-8.94||||||||-8.94|-38.75|
91666319|NCT00073307|183226275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0287||95.0|0.62|0.97||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||0.97|0.62|0.0287
91483684|NCT05323656|182840839|OTHER||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.039||0.123|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.123
91525747|NCT01350141|182926926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.185||||0.0121|TWO_SIDED|95.0|2.37|1107.57|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1107.57|2.37|0.0121
91631782|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.38|||||TWO_SIDED|95.0|-37.14|-9.61||||||||-9.61|-37.14|
91631783|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.6|||||TWO_SIDED|95.0|-53.18|-28.02||||||||-28.02|-53.18|
91631784|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.75|||||TWO_SIDED|95.0|-54.93|-30.58||||||||-30.58|-54.93|
91631785|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-19.7|8.98||||||||8.98|-19.70|
91631786|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.89|||||TWO_SIDED|95.0|-18.13|8.35||||||||8.35|-18.13|
91631787|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.11|||||TWO_SIDED|95.0|-34.22|-10.01||||||||-10.01|-34.22|
91631788|NCT01263470|183156744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.27|||||TWO_SIDED|95.0|-35.98|-12.55||||||||-12.55|-35.98|
91631789|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.31|||||TWO_SIDED|95.0|-80.79|-35.83||||||||-35.83|-80.79|
91631790|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.66|||||TWO_SIDED|95.0|-80.84|-40.47||||||||-40.47|-80.84|
91631791|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-78.72|||||TWO_SIDED|95.0|-97.03|-60.4||||||||-60.40|-97.03|
91483685|NCT05323656|182840840|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.017||0.41|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.41
91483686|NCT05323656|182840840|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.023||0.11|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.11
91483687|NCT03880461|182840847|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91483688|NCT03880461|182840848|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91483689|NCT03880461|182840849|SUPERIORITY|||||||0.108|||||||ANOVA|||||||0.108
91631792|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.43|||||TWO_SIDED|95.0|-106.26|-68.6||||||||-68.60|-106.26|
91631793|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-24.69|19.23||||||||19.23|-24.69|
91631794|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|95.0|-24.85|14.7||||||||14.70|-24.85|
91631795|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.13|||||TWO_SIDED|95.0|-41.16|-5.11||||||||-5.11|-41.16|
91631796|NCT01263470|183156745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.84|||||TWO_SIDED|95.0|-50.36|-13.33||||||||-13.33|-50.36|
91631797|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.859|||||TWO_SIDED|95.0|-2.736|8.455||||||||8.455|-2.736|
91631798|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.456|||||TWO_SIDED|95.0|0.748|10.165||||||||10.165|0.748|
91631799|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.715|||||TWO_SIDED|95.0|3.181|12.248||||||||12.248|3.181|
91631800|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.557|||||TWO_SIDED|95.0|-3.763|8.877||||||||8.877|-3.763|
91631801|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|||||TWO_SIDED|95.0|7.924|21.396||||||||21.396|7.924|
91631802|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.257|||||TWO_SIDED|95.0|11.353|23.16||||||||23.160|11.353|
91631803|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.515|||||TWO_SIDED|95.0|13.629|25.401||||||||25.401|13.629|
91631804|NCT01263470|183156746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.357|||||TWO_SIDED|95.0|7.013|21.701||||||||21.701|7.013|
91714317|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|7.99||0.0016||95.0|-41.2|-9.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-9.7|-41.2|0.0016
91631805|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.535|||||TWO_SIDED|95.0|-0.019|1.089||||||||1.089|-0.019|
91631806|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|0.214|1.315||||||||1.315|0.214|
91631807|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.999|||||TWO_SIDED|95.0|0.418|1.58||||||||1.580|0.418|
91631808|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.959|||||TWO_SIDED|95.0|0.43|1.489||||||||1.489|0.430|
91631809|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.934|||||TWO_SIDED|95.0|0.315|1.552||||||||1.552|0.315|
91792433|NCT02278341|183462604|SUPERIORITY||LSM Difference|0.126|||=|0.845|TWO_SIDED|95.0|-1.135|1.387||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||1.387|-1.135|=0.845
91631810|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.163|||||TWO_SIDED|95.0|0.551|1.774||||||||1.774|0.551|
91631811|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.398|||||TWO_SIDED|95.0|0.759|2.036||||||||2.036|0.759|
91792434|NCT02278341|183462605|SUPERIORITY||LSM Difference|-0.128|||=|0.922|TWO_SIDED|95.0|-2.703|2.447||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||2.447|-2.703|=0.922
91631812|NCT01263470|183156747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.76|1.956||||||||1.956|0.760|
91631813|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||||TWO_SIDED|95.0|-7.87|16.38||||||||16.38|-7.87|
91631814|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26|||||TWO_SIDED|95.0|-0.9|23.42||||||||23.42|-0.90|
91631815|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-10.56|16.95||||||||16.95|-10.56|
91631816|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||||TWO_SIDED|95.0|-16.27|8.94||||||||8.94|-16.27|
91631817|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|||||TWO_SIDED|95.0|-9.79|19.29||||||||19.29|-9.79|
91631818|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.76|||||TWO_SIDED|95.0|-2.67|26.19||||||||26.19|-2.67|
91631819|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|||||TWO_SIDED|95.0|-12.02|19.4||||||||19.40|-12.02|
91631820|NCT01263470|183156748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||||TWO_SIDED|95.0|-18.04|11.71||||||||11.71|-18.04|
91631821|NCT01327573|183156750|SUPERIORITY_OR_OTHER|||||||0.09||||||"This p-value was for the overall slope difference between groups (i.e. the interaction between group and time).~Significance level was set at 0.1 a priori."|Mixed effects model analysis|||Analysis used eGFR, group, time, and group-by-time variables.||||0.09
91631822|NCT03070119|183156755|SUPERIORITY||Least square (LS) geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.69|1.08||||||Week 52 - The analysis was based on an analysis of covariance (ANCOVA) model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation (MI) including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.08|0.69|
91631823|NCT03070119|183156755|SUPERIORITY||LS geometric mean ratio|0.91|||=|0.3711|TWO_SIDED|95.0|0.75|1.11|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.11|0.75|=0.3711
91631824|NCT03070119|183156755|SUPERIORITY||LS geometric mean ratio|1.06|||=|0.6344|TWO_SIDED|95.0|0.84|1.34|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.34|0.84|=0.6344
91631825|NCT03070119|183156756|SUPERIORITY||LS geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.63|1.03||||||Week 52 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.03|0.63|
91631826|NCT03070119|183156756|SUPERIORITY||LS geometric mean ratio|0.83|||=|0.2306|TWO_SIDED|95.0|0.6|1.13|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.13|0.60|=0.2306
91483690|NCT04718103|182840939|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted Forced Expiratory Volume in one second (FEV1) and offset of log (total time in the study in years).|Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.36|0.73|||Negative Binomial Distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.73|0.36|<0.001
91483691|NCT04718103|182840940|SUPERIORITY||Least-square (LS) means|-2.31||||0.2|TWO_SIDED|95.0|-5.84|1.23|||Mixed Models Repeated Measures (MMRM)|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by SGRQ Total Score measured over the study intervention period of 52 weeks.||1.23|-5.84|0.200
91483692|NCT04718103|182840941|SUPERIORITY||Difference in Least-Square Mean|-0.11||||0.333|TWO_SIDED|95.0|-0.33|0.11|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.11|-0.33|0.333
91483693|NCT04718103|182840942|SUPERIORITY||Difference in Least-Square Means|0.056||||0.267|TWO_SIDED|95.0|-0.043|0.154|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.154|-0.043|0.267
91483694|NCT04718103|182840943|SUPERIORITY||Difference in Least square means|-0.21||||0.173|TWO_SIDED|95.0|-0.52|0.09|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.09|-0.52|0.173
91483695|NCT04718103|182840944|SUPERIORITY||Difference in Least square means|-0.21||||0.138|TWO_SIDED|95.0|-0.48|0.07|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.07|-0.48|0.138
91483696|NCT04718103|182840945|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted FEV1.|Rate Ratio|0.42||||0.087|TWO_SIDED|95.0|0.16|1.13|||Negative binomial distribution|||||1.13|0.16|0.087
91483697|NCT02393690|182840959|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
91483698|NCT02393690|182840960|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
91483699|NCT02393690|182840961|SUPERIORITY|||||||0.1764|||||||Log Rank|||||||0.1764
91483700|NCT02393690|182840962|SUPERIORITY|||||||0.0756|||||||Wilcoxon (Mann-Whitney)|||||||0.0756
91483701|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.25||||0.5196|TWO_SIDED|95.0|-1.02|0.52||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.25 hours||0.52|-1.02|0.5196
91483702|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.32||||0.3983|TWO_SIDED|95.0|-1.09|0.44||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change in VAS score from baseline at 0.5 hours||0.44|-1.09|0.3983
91483703|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.26||||0.489|TWO_SIDED|95.0|-1.03|0.5||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.75 hours||0.5|-1.03|0.4890
91483704|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.21||||0.5903|TWO_SIDED|95.0|-0.97|0.56||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 1 hour||0.56|-0.97|0.5903
91692037|NCT02174627|183278567|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.4|0.45|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.45|0.40|<0.001
91483705|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.13||||0.7352|TWO_SIDED|95.0|-0.9|0.64||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 1.5 hours||0.64|-0.90|0.7352
91631827|NCT03070119|183156756|SUPERIORITY||LS geometric mean ratio|0.92|||=|0.673|TWO_SIDED|95.0|0.61|1.38|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.38|0.61|=0.6730
91631828|NCT03070119|183156757|SUPERIORITY||Least square (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.5|6.7||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||6.7|0.5|
91631829|NCT03070119|183156757|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|2.28|=|0.1054|TWO_SIDED|95.0|-0.8|8.2|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.2|-0.8|=0.1054
91631830|NCT03070119|183156757|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|2.46|=|0.1432|TWO_SIDED|95.0|-1.2|8.4|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.4|-1.2|=0.1432
91631831|NCT03070119|183156758|SUPERIORITY||LS mean difference|8.1|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|0.3|15.9||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.9|0.3|
91631832|NCT03070119|183156758|SUPERIORITY||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.6|=|0.0963|TWO_SIDED|95.0|-1.7|20.4|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||20.4|-1.7|=0.0963
91631833|NCT03070119|183156758|SUPERIORITY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.56|=|0.4388|TWO_SIDED|95.0|-6.6|15.2|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.2|-6.6|= 0.4388
91631834|NCT03070119|183156759|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.051|0.477||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.477|0.051|
91631835|NCT03070119|183156759|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.145|=|0.3207|TWO_SIDED|95.0|-0.141|0.43|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.430|-0.141|=0.3207
91666320|NCT00073307|183226276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|1e-06||95.0|0.35|0.55|||Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01||0.55|0.35|<0.000001
91792435|NCT02047318|183462625|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-94.4|STANDARD_DEVIATION|98.915||0.0012|TWO_SIDED|95.0|-145.26|-43.55||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-43.55|-145.26|0.0012
91666321|NCT00073307|183226277|SUPERIORITY_OR_OTHER||Difference in response rates (CR+PR)|-2.1||||||95.0|-3.7|-0.6|||Cochran-Mantel-Haenszel|Adjustments for country and Motzer category|difference in response rates (CR+PR) = Placebo - Sorafenib|||-0.6|-3.7|
91631836|NCT03070119|183156759|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.091|=|0.5452|TWO_SIDED|95.0|-0.124|0.234|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.234|-0.124|=0.5452
91631837|NCT03070119|183156761|SUPERIORITY||Hazard Ratio (HR)|0.64|||=|0.4202|TWO_SIDED|95.0|0.282|1.461|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.461|0.282|=0.4202
91631838|NCT03070119|183156762|SUPERIORITY||Hazard Ratio (HR)|0.52|||=|0.3108|TWO_SIDED|95.0|0.199|1.357|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.357|0.199|=0.3108
91631839|NCT01996865|183156763|OTHER||Hazard Ratio (HR)|0.8||||0.3296|TWO_SIDED|95.0|0.6|1.2|||Regression, Cox|||||1.2|0.6|0.3296
91631840|NCT01996865|183156764|OTHER||Hazard Ratio (HR)|0.7||||0.1222|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox|||||1.1|0.4|0.1222
91631841|NCT00557362|183156886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.29|TWO_SIDED|95.0|-0.28|0.083|||Regression, Linear|Multiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization||||0.083|-0.28|0.29
91631842|NCT00557362|183156887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.4|TWO_SIDED|95.0|0.76|2.02|||Regression, Cox|||||2.02|0.76|0.40
91631843|NCT00557362|183156888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.37|TWO_SIDED|95.0|-0.2|0.53|||Regression, Linear|||||0.53|-0.20|0.37
91483706|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2 hours||0.61|-0.92|0.6892
91631844|NCT00557362|183156889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.62|TWO_SIDED|95.0|-0.25|0.41|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.||0.41|-0.25|0.62
91631845|NCT00557362|183156889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.26|TWO_SIDED|95.0|-0.57|0.17|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.||0.17|-0.57|0.26
91631846|NCT00557362|183156890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.53|TWO_SIDED|95.0|-0.26|0.14|||Regression, Linear|||||0.14|-0.26|0.53
91666322|NCT00073307|183226278|SUPERIORITY_OR_OTHER|||||||0.98|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline FKSI-10 score and relative day of FKSI-10 completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.98
91631847|NCT00397631|183156919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.12|<|0.001||95.0|-1.13|-0.65|||ANCOVA|Model terms: treatment, baseline HbA1c||||-0.65|-1.13|<0.001
91666323|NCT00073307|183226279|SUPERIORITY_OR_OTHER|||||||0.83|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.83
91631848|NCT00397631|183156920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.8|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-30.4|-15.2|||ANCOVA|Model terms: treatment, baseline FPG||||-15.2|-30.4|<0.001
91631849|NCT00397631|183156921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.7|STANDARD_ERROR_OF_MEAN|6.37|<|0.001||95.0|-57.2|32.2|||ANCOVA|Model terms: treatment, baseline 2-hour PPG||||32.2|-57.2|<0.001
91666324|NCT00858780|183226280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.17||||0.007|TWO_SIDED|95.0|1.72|29.82|||GEE Model|||Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||29.82|1.72|0.007
91666325|NCT00858780|183226280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.362|TWO_SIDED|95.0|0.54|5.41|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||5.41|0.54|0.362
91666326|NCT00858780|183226280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2||||0.044|TWO_SIDED|95.0|1.04|16.99|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||16.99|1.04|0.044
91666327|NCT03306277|183226319|SUPERIORITY||||||<|0.0001|||||||One-sided Exact Binomial Test|||This comparison is made to an assumed rate of zero 0 (or as low as 0.1%). By definition, children with spinal muscular atrophy Type 1 are never able to sit independently.||||<0.0001
91666328|NCT03306277|183226320|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||This comparison is made against the results from the age and gender-matched control participants selected from existing natural history data sets (PNCR) \[Neurol. 2014; 83(9):810-817\].|Data for the current study were compared to historical control data (Finkel et al,2014 - PubMed 25080519) where event-free survival was 6 out of 23 participants (26.1%) at 14 months of age.|||<0.0001
91483707|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.01||||0.9767|TWO_SIDED|95.0|-0.78|0.76||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2.5 hours||0.76|-0.78|0.9767
91631850|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-1.17|||||TWO_SIDED|95.0|-25.61|23.27|||||Comparison for fasting, Day 7|An estimation approach was used.||23.27|-25.61|
91792436|NCT02047318|183462626|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-141.94|STANDARD_DEVIATION|117.992||0.032|TWO_SIDED|95.0|-265.77|-18.12||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-18.12|-265.77|0.032
91631851|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|13.22|||||TWO_SIDED|95.0|-9.84|36.27|||||Comparison for fasting, Day 7|An estimation approach was used.||36.27|-9.84|
91631852|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.77|||||TWO_SIDED|95.0|-41.43|-2.1|||||Comparison for fasting, Day 7|An estimation approach was used.||-2.10|-41.43|
91631853|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.1|||||TWO_SIDED|95.0|-42.63|-3.57|||||Comparison for fasting, Day 7|An estimation approach was used.||-3.57|-42.63|
91631854|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.79|||||TWO_SIDED|95.0|-30.85|7.28|||||Comparison for fasting, Day 7|An estimation approach was used.||7.28|-30.85|
91631855|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.04|||||TWO_SIDED|95.0|-27.66|7.57|||||Comparison for fasting, Day 7|An estimation approach was used.||7.57|-27.66|
91631856|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.14|||||TWO_SIDED|95.0|-37.72|7.43|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.43|-37.72|
91631857|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-2.1|||||TWO_SIDED|95.0|-23.66|19.45|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||19.45|-23.66|
91631858|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-20.66|||||TWO_SIDED|95.0|-38.75|-2.57|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-2.57|-38.75|
91631859|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.7|||||TWO_SIDED|95.0|-39.7|-3.71|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-3.71|-39.70|
91631860|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.62|||||TWO_SIDED|95.0|-28.62|7.38|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.38|-28.62|
91631861|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-26.03|||||TWO_SIDED|95.0|-41.94|-10.12|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-10.12|-41.94|
91631862|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-12.1|||||TWO_SIDED|95.0|-33.56|9.36|||||Comparison for fasting, Day 14|An estimation approach was used.||9.36|-33.56|
91666329|NCT02227238|183226376|SUPERIORITY|Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG - LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.|Proportion difference|13.8|||<|0.001|TWO_SIDED|95.0|7.3|20.3|||Cochran-Mantel-Haenszel||Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.||Superiority would be declared if the lower end of the confidence interval was above 0%|20.3|7.3|<.001
91666330|NCT02227238|183226379|OTHER||Proportion difference|5.7|||||TWO_SIDED|95.0|2.2|9.3|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.|||9.3|2.2|
91631863|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.33|||||TWO_SIDED|95.0|-15.91|24.57|||||Comparison for fasting, Day 14|An estimation approach was used.||24.57|-15.91|
91483708|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Median Difference (Net)|0.32||||0.3964|TWO_SIDED|95.0|-0.44|1.09||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3 hours||1.09|-0.44|0.3964
91525748|NCT01454830|182926957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.44||0.2|TWO_SIDED||||||t-test, 2 sided||unit of measurement, hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.20
91631864|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-25.29|||||TWO_SIDED|95.0|-42.56|-8.02|||||Comparison for fasting, Day 14|An estimation approach was used.||-8.02|-42.56|
91631865|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.97|||||TWO_SIDED|95.0|-37.12|-2.82|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.82|-37.12|
91631866|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.82|||||TWO_SIDED|95.0|-38.56|-5.08|||||Comparison for fasting, Day 14|An estimation approach was used.||-5.08|-38.56|
91631867|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-18.01|||||TWO_SIDED|95.0|-33.48|-2.55|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.55|-33.48|
91631868|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.2|||||TWO_SIDED|95.0|-33.21|10.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||10.81|-33.21|
91631869|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.8|||||TWO_SIDED|95.0|-16.22|25.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||25.81|-16.22|
91631870|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.23|||||TWO_SIDED|95.0|-32.86|2.41|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||2.41|-32.86|
91631871|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-17.01|||||TWO_SIDED|95.0|-34.56|0.53|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||0.53|-34.56|
91631872|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.94|||||TWO_SIDED|95.0|-41.49|-6.39|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-6.39|-41.49|
91666331|NCT02227238|183226379|OTHER||Proportion difference|9.8|||||TWO_SIDED|95.0|5.3|14.4|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.|||14.4|5.3|
91666332|NCT02227238|183226406|OTHER||Mean Difference (Net)|-0.171||||0.001|TWO_SIDED|95.0|-0.272|-0.069|||Multiple imputation||Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.069|-0.272|0.0010
91666333|NCT02227238|183226406|OTHER||Mean Difference (Net)|-0.147||||0.01|TWO_SIDED|95.0|-0.259|-0.035|||'Multiple imputation||Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.035|-0.259|0.0100
91483709|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|0.22||||0.5669|TWO_SIDED|95.0|-0.55|0.98||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3.5 hours||0.98|-0.55|0.5669
91483710|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.7006|TWO_SIDED|95.0|-0.91|0.62||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 4 hours||0.62|-0.91|0.7006
91483711|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.1||||0.794|TWO_SIDED|95.0|-0.87|0.67||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 5 hours||0.67|-0.87|0.7940
91483712|NCT05298306|182840966|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61|||Mixed Models Analysis|No adjustment for multiple comparisons was made due to the exploratory nature of the study.||Change from baseline VAS score at 6 hours|Difference is LAT8881 minus placebo.|0.61|-0.92|0.6892
91483713|NCT00144027|182840984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.57||||0.03|TWO_SIDED|95.0|1.21|47.53|||Regression, Logistic|logistic regression predicting 6-month adherence, controling for baseline depression, extrapyramidal side effects, and baseline adherence.||||47.53|1.21|0.03
91483714|NCT05080660|182840985|SUPERIORITY||Posterior Mean Difference|0.23|||||TWO_SIDED|95.0|-0.26|0.73|||||Posterior mean difference with 95% credible interval is reported.|||0.73|-0.26|
91483715|NCT05080660|182840986|SUPERIORITY||Posterior Mean Difference|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||Posterior mean difference with 95% credible interval is reported.|||0.76|-0.39|
91483716|NCT05080660|182840987|SUPERIORITY||Posterior Mean Difference|0.62|||||TWO_SIDED|95.0|-0.23|1.47|||||Posterior mean difference with 95% credible interval is reported.|||1.47|-0.23|
91483717|NCT05080660|182840988|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-0.67|1.34|||||Posterior mean difference with 95% credible interval is reported.|||1.34|-0.67|
91483718|NCT05080660|182840989|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.35|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.35|
91483719|NCT05080660|182840990|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.35|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.35|
91483720|NCT05080660|182840991|SUPERIORITY||Posterior Mean Difference|1.98|||||TWO_SIDED|95.0|-0.88|4.88|||||Posterior mean difference with 95% credible interval is reported.|||4.88|-0.88|
91631873|NCT02202161|183156922|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.45|||||TWO_SIDED|95.0|-34.96|-3.93|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-3.93|-34.96|
91666334|NCT02227238|183226407|OTHER||Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.729|-0.356|||Multiple imputation||Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.356|-0.729|<0.0001
91666335|NCT02227238|183226407|OTHER||Mean Difference (Net)|-0.358||||0.0004|TWO_SIDED|95.0|-0.555|-0.161|||Multiple imputation||Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.161|-0.555|0.0004
91483721|NCT05080660|182840992|SUPERIORITY||Posterior Mean Difference|3.05|||||TWO_SIDED|95.0|-0.29|6.38|||||Posterior mean difference with 95% credible interval is reported.|||6.38|-0.29|
91631874|NCT02202161|183156937|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.17|||||TWO_SIDED|90.0|0.92|1.49|||||Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|0.92|
91666336|NCT00380588|183226414|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||P-value for response (Complete Response + Partial Response).|Fisher Exact|||||||0.380
91483722|NCT05080660|182840993|SUPERIORITY||Posterior Mean Difference|0.13|||||TWO_SIDED|95.0|-0.23|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.23|
91483723|NCT05080660|182840994|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.39|0.37|||||Posterior mean difference with 95% credible interval is reported.|||0.37|-0.39|
91483724|NCT05080660|182840995|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.21|0.81|||||Posterior mean difference with 95% credible interval is reported.|||0.81|-0.21|
91483725|NCT05080660|182840996|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.31|0.9|||||Posterior mean difference with 95% credible interval is reported.|||0.90|-0.31|
91666337|NCT00380588|183226415|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Log Rank|||||||0.074
91666338|NCT00380588|183226416|SUPERIORITY_OR_OTHER|||||||0.136||95.0|||||Log Rank|||||||0.136
91666339|NCT02096705|183226417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.0968|<|0.0001|TWO_SIDED|95.0|-1.09|-0.71||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.71|-1.09|<0.0001
91483726|NCT05080660|182840997|SUPERIORITY||Posterior Mean Difference|6.14|||||TWO_SIDED|95.0|-0.24|12.52|||||Posterior mean difference with 95% credible interval is reported.|||12.52|-0.24|
91483727|NCT05080660|182840998|SUPERIORITY||Posterior Mean Difference|5.15|||||TWO_SIDED|95.0|-1.9|12.18|||||Posterior mean difference with 95% credible interval is reported.|||12.18|-1.90|
91483728|NCT05080660|182840999|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.32|0.27|||||Posterior mean difference with 95% credible interval is reported.|||0.27|-0.32|
91483729|NCT05080660|182841000|SUPERIORITY||Posterior Mean Difference|-0.2|||||TWO_SIDED|95.0|-0.52|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.52|
91483730|NCT05080660|182841001|SUPERIORITY||Posterior Mean Difference|98.35|||||TWO_SIDED|95.0|-51.95|250.88|||||Posterior mean difference with 95% credible interval is reported.|||250.88|-51.95|
91483731|NCT05080660|182841002|SUPERIORITY||Posterior Mean Difference|123.36|||||TWO_SIDED|95.0|-46.51|293.69|||||Posterior mean difference with 95% credible interval is reported.|||293.69|-46.51|
91483732|NCT05080660|182841003|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.06|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.06|
91483733|NCT05080660|182841004|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.07|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.07|
91483734|NCT01977937|182841019|OTHER|Differences in average pre-operative \& total post-operative average VAS scores were compared between groups using an unpaired Mann-Whitney rank sum test. Hospitalization outcomes including number of days to transition off PCA, number of days with Foley catheter, \& episodes of nausea, emesis, or POSS \> 3 were compared between groups using an unpaired two-tailed Student's t-test. Statistical significance was defined as p\<0.05 for all unpaired parametric and non-parametric comparisons.||||||0.07|||||||t-test, 2 sided|||D'Agostino \& Pearson normality test was used to assess for normal distribution. Experimental \& control groups were assessed for significant differences in age, hospital days, \& spinal levels fused using unpaired two-tailed Student's t-test. Differences in weight \& BMI were assessed using unpaired Mann-Whitney rank sum test. Differences in average VAS scores on the operative day, each post-operative day, and average total daily opioid were compared using an unpaired two-tailed Student's t-test.||||0.07
91483735|NCT01977937|182841020|OTHER|||||||0.02|||||||t-test, 2 sided|||Differences in the average total daily opioid were compared between groups using an unpaired two-tailed Student's t-test||||0.02
91483736|NCT03911843|182841046|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0||||the p-value of significance was calculated using the analysis system|Wilcoxon (Mann-Whitney)|||||||<0.05
91483737|NCT03911843|182841046|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91483738|NCT03911843|182841047|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91483739|NCT03911843|182841048|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91483740|NCT02819518|182841051|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.012|TWO_SIDED|95.0|0.7|0.98||One-sided p-value based on log-rank test stratified by chemotherapy (taxane versus \[vs\] gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs. no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.98|0.70|0.0120
91483741|NCT02819518|182841052|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0016|TWO_SIDED|95.0|0.62|0.91||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.91|0.62|0.0016
91483742|NCT02819518|182841053|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0018|TWO_SIDED|95.0|0.5|0.88||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.88|0.50|0.0018
91483743|NCT02819518|182841054|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0797|TWO_SIDED|95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.05|0.76|0.0797
91483744|NCT02819518|182841055|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0563|TWO_SIDED|95.0|0.72|1.04||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.04|0.72|0.0563
91483745|NCT02819518|182841056|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0093|TWO_SIDED|95.0|0.55|0.95||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.95|0.55|0.0093
91631875|NCT02202161|183156937|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.38|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.38|0.89|
91631876|NCT02202161|183156937|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.05|||||TWO_SIDED|90.0|0.87|1.27|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.27|0.87|
91483746|NCT02819518|182841057|SUPERIORITY||Difference in ORR (%) vs. Control|3.8||||0.1413|TWO_SIDED|95.0|-3.2|10.6|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||10.6|-3.2|0.1413
91483747|NCT02819518|182841058|SUPERIORITY||Difference in ORR (%) vs. Control|6.1||||0.0725|TWO_SIDED|95.0|-2.1|14.0|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||14.0|-2.1|0.0725
91631877|NCT02202161|183156937|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.03|1.52|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.52|1.03|
91483748|NCT02819518|182841059|SUPERIORITY||Difference in ORR(%) vs. Control|12.1||||0.0213|TWO_SIDED|95.0|0.4|23.4|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||23.4|0.4|0.0213
91483749|NCT02819518|182841063|SUPERIORITY||Difference in DCR (%) vs. control|4.7||||0.0966|TWO_SIDED|95.0|-2.4|11.8|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||11.8|-2.4|0.0966
91483750|NCT02819518|182841064|SUPERIORITY||Difference in DCR (%) vs. Control|5.0||||0.1164|TWO_SIDED|95.0|-3.2|13.1|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||13.1|-3.2|0.1164
91483751|NCT02819518|182841065|SUPERIORITY||Difference in DCR (%) vs. Control|10.8||||0.0327|TWO_SIDED|95.0|-0.7|22.3|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||22.3|-0.7|0.0327
91483752|NCT01505647|182841074|NON_INFERIORITY_OR_EQUIVALENCE|The GMT induced by ZOSTAVAX™ (AMP) vaccine is statistically non-inferior to that induced by the current process vaccine if the lower bound of the 95% confidence interval of the GMT ratio is \>0.67.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.98|1.2||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||The hypothesis tested is that the GMT at Week 6 postvaccination with ZOSTAVAX™ (AMP) vaccine is non-inferior to that with the current process vaccine||1.20|0.98|<0.001
91483753|NCT01505647|182841075|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|t-test, 1 sided|||The hypothesis tested was that ZOSTAVAX™ (AMP) induces an acceptable GMFR in VZV antibody titer from prevaccination to 6 weeks postvaccination||||<0.001
91483754|NCT02750943|182841093|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-25.34|||<|0.0001|TWO_SIDED|95.0|-30.682|-19.998||From ANCOVA analysis with treatment group, gender and baseline MGI stratification as factors baseline as covariates.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-19.998|-30.682|<0.0001
91483755|NCT05419908|182841137|SUPERIORITY||LSMean Difference|-12.34|||<|0.001|TWO_SIDED|95.0|-16.89|-7.79||Least square (LS) mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|Analysis of Covariance (ANCOVA)||||-7.79|-16.89|<0.001
91483756|NCT05419908|182841138|SUPERIORITY||LSMean Difference|-1.134|||<|0.001|TWO_SIDED|95.0|-1.466|-0.802||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-0.802|-1.466|<0.001
91483757|NCT05419908|182841138|SUPERIORITY||LSMean Difference|-0.948|||<|0.001||95.0|-1.362|-0.535||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-0.535|-1.362|<0.001
91483758|NCT05419908|182841138|SUPERIORITY||LSMean Difference|-1.122|||<|0.001|TWO_SIDED|95.0|-1.504|-0.741||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-0.741|-1.504|<0.001
91483759|NCT05419908|182841139|SUPERIORITY||LSMean Difference|-13.28|||<|0.001||95.0|-17.02|-9.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-9.54|-17.02|<0.001
91483760|NCT05419908|182841139|SUPERIORITY||LSMean Difference|-11.78|||<|0.001|TWO_SIDED|95.0|-16.3|-7.27||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-7.27|-16.30|<0.001
91483761|NCT05419908|182841139|SUPERIORITY||LSMean Difference|-12.42|||<|0.001||95.0|-17.0|-7.83||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-7.83|-17.00|<0.001
91483762|NCT05419908|182841140|SUPERIORITY||LSMean Difference|-39.8|||<|0.001|TWO_SIDED|95.0|-50.5|-29.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-29.1|-50.5|<0.001
91483763|NCT05419908|182841140|SUPERIORITY||LSMean Difference|-35.5|||<|0.001|TWO_SIDED|95.0|-47.9|-23.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-23.0|-47.9|<0.001
91483764|NCT05419908|182841140|SUPERIORITY||LSMean Difference|-35.0|||<|0.001||95.0|-47.9|-22.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-22.1|-47.9|<0.001
91525749|NCT01454830|182926958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.48||0.9|TWO_SIDED||||||t-test, 2 sided||unit of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.90
91631878|NCT02202161|183156937|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.04|1.5|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.50|1.04|
91666340|NCT02096705|183226418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.69|STANDARD_ERROR_OF_MEAN|4.605|<|0.0001|TWO_SIDED|95.0|-39.76|-21.61|||Longitudinal repeated measure analysis|P-value for Dapagliflozin vs. placebo|Difference of Dapagliflozin from placebo|||-21.61|-39.76|<0.0001
91714318|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.5976||95.0|-20.5|11.8|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-20.5|0.5976
91714319|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|8.0||0.8527||95.0|-14.3|17.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-14.3|0.8527
91792437|NCT02047318|183462627|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-1.095|STANDARD_DEVIATION|0.7173|<|0.0001|TWO_SIDED|95.0|-1.464|-0.726||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-0.726|-1.464|< 0.0001
91483765|NCT05419908|182841141|SUPERIORITY||Percentage Difference|65.1|||<|0.001|TWO_SIDED|95.0|49.15|81.0||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||81.00|49.15|<0.001
91483766|NCT05419908|182841141|SUPERIORITY||Percentage Difference|48.5|||<|0.001||95.0|30.37|66.59||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||66.59|30.37|<0.001
91483767|NCT05419908|182841141|SUPERIORITY||Percentage Difference|52.5|||<|0.001|TWO_SIDED|95.0|35.76|69.24||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||69.24|35.76|<0.001
91631879|NCT02202161|183156937|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.94|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.94|
91631880|NCT02202161|183156939|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|0.88|||||TWO_SIDED|90.0|0.68|1.13|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.13|0.68|
91631881|NCT02202161|183156939|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.82|
91631882|NCT02202161|183156939|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.85|1.26|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.26|0.85|
91631883|NCT02202161|183156939|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.19|||||TWO_SIDED|90.0|0.97|1.45|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.45|0.97|
91631884|NCT02202161|183156939|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.23|||||TWO_SIDED|90.0|1.01|1.49|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|1.01|
91714320|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.29||0.6973||95.0|-19.6|13.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.1|-19.6|0.6973
91525750|NCT01454830|182926959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.53||0.89|TWO_SIDED||||||t-test, 2 sided||units of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.89
91631885|NCT02202161|183156939|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.24|||||TWO_SIDED|90.0|1.04|1.48|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.48|1.04|
91631886|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.91|1.17|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.17|0.91|
91631887|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.88|||||TWO_SIDED|95.0|0.78|0.98|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.98|0.78|
91483768|NCT05419908|182841142|SUPERIORITY||Percentage Difference|69.0|||<|0.001|TWO_SIDED|95.0|53.7|84.21||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||84.21|53.70|<0.001
91631888|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|0.78|0.95|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.95|0.78|
91631889|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|0.68|0.83|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.83|0.68|
91631890|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.76|0.92|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.92|0.76|
91631891|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.10|0.92|
91631892|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.95|1.19|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.19|0.95|
91631893|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|0.94|1.16|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.16|0.94|
91631894|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.88|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.88|
91631895|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.89|1.07|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.07|0.89|
91631896|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.98|1.17|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.17|0.98|
91666341|NCT02096705|183226419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3057|<|0.0001|TWO_SIDED|95.0|-1.98|-0.77||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.77|-1.98|<0.0001
91666342|NCT02096705|183226420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.5171||0.0059|TWO_SIDED|95.0|-2.45|-0.42||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.42|-2.45|0.0059
91666343|NCT02377349|183226438|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PT antibodies was greater than or equal to (≥) 1.5.|GMC ratio|8.47|||||TWO_SIDED|95.0|7.02|10.2|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||10.2|7.02|
91631897|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.90|
91631898|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.13|0.80|
91631899|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.90|0.65|
91631900|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.64|0.85|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.85|0.64|
91631901|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.69|0.51|
91483769|NCT05419908|182841142|SUPERIORITY||Percentage Difference|50.7|||<|0.001||95.0|31.93|69.42||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 8||69.42|31.93|<0.001
91483770|NCT05419908|182841142|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|39.99|75.01||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 12||75.01|39.99|<0.001
91483771|NCT05419908|182841143|SUPERIORITY||Percentage Difference|54.2|||<|0.001|TWO_SIDED|95.0|37.47|70.84||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||70.84|37.47|<0.001
91483772|NCT05419908|182841143|SUPERIORITY||Percentage Difference|47.8|||<|0.001||95.0|29.62|65.99||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||65.99|29.62|<0.001
91483773|NCT05419908|182841143|SUPERIORITY||Percentage Difference|47.5|||<|0.001||95.0|28.86|66.14||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||66.14|28.86|<0.001
91483774|NCT05419908|182841144|SUPERIORITY||Percentage Difference|49.7|||<|0.001||95.0|33.54|65.79||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||65.79|33.54|<0.001
91483775|NCT05419908|182841144|SUPERIORITY||Percentage Difference|43.8|||<|0.001|TWO_SIDED|95.0|27.83|59.85||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||59.85|27.83|<0.001
91483776|NCT05419908|182841144|SUPERIORITY||Percentage Difference|42.5|||<|0.001||95.0|26.34|58.66||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||58.66|26.34|<0.001
91483777|NCT05419908|182841145|SUPERIORITY||Percentage Difference|62.8|||<|0.001|TWO_SIDED|95.0|46.56|79.05||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||79.05|46.56|<0.001
91631902|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.81|0.62|
91525751|NCT01454830|182926960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|4.09||0.78|TWO_SIDED||||||t-test, 2 sided||units of measurement: % TST; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).||||0.78
91631903|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.14|0.89|
91631904|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.21|0.88|
91483778|NCT05419908|182841145|SUPERIORITY||Percentage Difference|46.2|||<|0.001|TWO_SIDED|95.0|28.85|63.47||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||63.47|28.85|<0.001
91483779|NCT05419908|182841145|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|41.57|73.43||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||73.43|41.57|<0.001
91483780|NCT05419908|182841146|SUPERIORITY||Percentage Difference|61.5|||<|0.001||95.0|45.4|77.55||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||77.55|45.40|<0.001
91483781|NCT05419908|182841146|SUPERIORITY||Percentage Difference|43.1|||<|0.001|TWO_SIDED|95.0|23.53|62.69||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||62.69|23.53|<0.001
91483782|NCT05419908|182841146|SUPERIORITY||Percentage Difference|52.5|||<|0.001||95.0|33.92|71.08||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||71.08|33.92|<0.001
91483783|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.45|-1.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Work||-1.60|-3.45|<0.001
91483784|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.29|||<|0.001|TWO_SIDED|95.0|-3.15|-1.42||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Work||-1.42|-3.15|<0.001
91483785|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.03|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Work||-1.20|-3.03|<0.001
91483786|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.19|-1.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Social Activities||-1.46|-3.19|<0.001
91483787|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.21|-1.47||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Social Activties||-1.47|-3.21|<0.001
91483788|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.19|||<|0.001|TWO_SIDED|95.0|-3.09|-1.29||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Social Activties||-1.29|-3.09|<0.001
91483789|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.99|-1.31||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Leisure Activities||-1.31|-2.99|<0.001
91483790|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.37|||<|0.001|TWO_SIDED|95.0|-3.19|-1.55||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Leisure Activties||-1.55|-3.19|<0.001
91631905|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.71|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.71|
91631906|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.74|
91631907|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.59|0.76|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.76|0.59|
91631908|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.87|0.68|
91483791|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.64||||0.002|TWO_SIDED|95.0|-2.66|-0.62||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Leisure Activties||-0.62|-2.66|0.002
91483792|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.93|||<|0.001|TWO_SIDED|95.0|-4.08|-1.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sleep||-1.78|-4.08|<0.001
91483793|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.86|-1.57||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sleep||-1.57|-3.86|<0.001
91483794|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.61|||<|0.001|TWO_SIDED|95.0|-3.67|-1.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sleep||-1.54|-3.67|<0.001
91483795|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.74|||<|0.001|TWO_SIDED|95.0|-2.67|-0.81||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Mood||-0.81|-2.67|<0.001
91525752|NCT03810313|182926964|NON_INFERIORITY|Non-inferiority was considered to be established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is \> -4 letters.|Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.173|TWO_SIDED|95.0|-5.2|-0.5|||ANOVA|||||-0.5|-5.2|0.173
91525753|NCT01077362|182927048|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525754|NCT01077362|182927048|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525755|NCT01077362|182927048|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91666344|NCT02377349|183226438|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-FHA antibodies was greater than or equal to (≥) 1.5.|GMC ratio|16.11|||||TWO_SIDED|95.0|13.48|19.24|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||19.24|13.48|
91666345|NCT02377349|183226438|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PRN antibodies was greater than or equal to (≥) 1.5.|GMC ratio|20.65|||||TWO_SIDED|95.0|15.86|26.88|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||26.88|15.86|
91666346|NCT01395017|183226480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.3864|TWO_SIDED|95.0|0.85|1.65||The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio \[HR\] =0.75, assuming analysis of 135 deaths).||1.65|0.85|0.3864
91692038|NCT02174627|183278568|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.033|<|0.001|TWO_SIDED|95.0|-0.42|-0.29|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||-0.29|-0.42|<0.001
91525756|NCT01077362|182927049|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
91525757|NCT01077362|182927049|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525758|NCT01077362|182927049|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525759|NCT01077362|182927050|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525760|NCT01077362|182927050|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525761|NCT01077362|182927050|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91631909|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.92|1.14|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.14|0.92|
91631910|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.27|||||TWO_SIDED|95.0|0.97|1.66|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.66|0.97|
91631911|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|0.9|1.5|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.50|0.90|
91631912|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|1.06|1.61|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.61|1.06|
91483796|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.12|||<|0.001|TWO_SIDED|95.0|-3.09|-1.16||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Mood||-1.16|-3.09|<0.001
91631913|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.48|0.96|
91483797|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.79|||<|0.001|TWO_SIDED|95.0|-2.69|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Mood||-0.88|-2.69|<0.001
91483798|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Concentration||-0.97|-2.86|<0.001
91483799|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.23|||<|0.001|TWO_SIDED|94.0|-3.21|-1.25||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Concentration||-1.25|-3.21|<0.001
91525762|NCT01077362|182927051|SUPERIORITY_OR_OTHER|||||||0.018|||||||re-randomization test|||||||0.018
91525763|NCT01077362|182927051|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91631914|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.15|||||TWO_SIDED|95.0|0.93|1.42|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.42|0.93|
91631915|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.79|1.16|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.16|0.79|
91631916|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.86|1.17|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.17|0.86|
91631917|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.73|0.96|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.96|0.73|
91631918|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.73|0.91|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.91|0.73|
91666347|NCT01395017|183226481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.6761|TWO_SIDED|95.0|0.73|1.34||The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).||1.34|0.73|0.6761
91631919|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.66|0.82|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.82|0.66|
91666348|NCT02235870|183226484|SUPERIORITY||Least-Square Mean Difference|3.28||||0.0261|TWO_SIDED|95.0|2.24|4.32|||ANCOVA|||||4.32|2.24|0.0261
91666349|NCT02235870|183226485|SUPERIORITY||Exact Confidence Interval|64.9|||<|0.0001|TWO_SIDED|95.0|57.5|71.7|||Exact Test|||Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.||71.7|57.5|<0.0001
91666350|NCT02235870|183226486|SUPERIORITY||Percentage Difference|32.8|||<|0.0001|TWO_SIDED|95.0|23.1|42.5|||Chi-squared|||||42.5|23.1|<0.0001
91666351|NCT02286466|183226600|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.38||0.412|TWO_SIDED|95.0|-1.6|3.87||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcomes and psychotropic medication use||Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||3.87|-1.60|0.412
91525764|NCT01077362|182927051|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
91525765|NCT01077362|182927052|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
91525766|NCT01077362|182927052|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525767|NCT01077362|182927052|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91525768|NCT01077362|182927053|SUPERIORITY_OR_OTHER|||||||0.171|||||||re-randomization|||||||0.171
91631920|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.69|0.86|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.86|0.69|
91631921|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.03|0.84|
91631922|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.09|||||TWO_SIDED|95.0|0.99|1.21|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.21|0.99|
91631923|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.11|0.93|
91631924|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.90|
91483800|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.91|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Concentration||-0.88|-2.91|<0.001
91483801|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.33||||0.003|TWO_SIDED|95.0|-2.2|-0.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Relations With Others||-0.46|-2.20|0.003
91483802|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Relations With others||-0.90|-2.80|<0.001
91631925|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.06|0.92|
91631926|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.94|1.08|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.08|0.94|
91631927|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.92|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.92|
91525769|NCT01077362|182927053|SUPERIORITY_OR_OTHER|||||||0.06|||||||re-randomization test|||||||0.060
91666352|NCT02286466|183226601|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|2.51||0.997|TWO_SIDED|95.0|-4.99|4.96||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use||4.96|-4.99|0.997
91666353|NCT02286466|183226602|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.63||0.215|TWO_SIDED|95.0|-0.46|2.02||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||2.02|-0.46|0.215
91666354|NCT02286466|183226602|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.379|TWO_SIDED|95.0|-0.6|1.57||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.57|-0.60|0.379
91483803|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.72|||<|0.001|TWO_SIDED|95.0|-2.66|-0.77||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Relations With Others||-0.77|-2.66|<0.001
91483804|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.06||||0.081|TWO_SIDED|95.0|-2.25|0.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sexuality||0.13|-2.25|0.081
91483805|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.4||||0.05|TWO_SIDED|95.0|-2.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sexuality||0.00|-2.80|0.050
91483806|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.51||||0.026|TWO_SIDED|95.0|-2.84|-0.19||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sexuality||-0.19|-2.84|0.026
91483807|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.51|-0.79||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Enjoyment of Life||-0.79|-2.51|<0.001
91525770|NCT01077362|182927053|SUPERIORITY_OR_OTHER|||||||0.094|||||||re-randomization|||||||0.094
91631928|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.85|||||TWO_SIDED|95.0|0.69|1.04|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.04|0.69|
91631929|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.85|0.58|
91631930|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.62|0.86|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.86|0.62|
91631931|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|0.5|0.71|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.71|0.50|
91631932|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.59|0.8|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.80|0.59|
91666355|NCT02286466|183226603|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.81||0.852|TWO_SIDED|95.0|-1.45|1.75||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.75|-1.45|0.852
91483808|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Enjoyment of Life||-1.18|-2.97|<0.001
91483809|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.88|-0.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Enjoyment of Life||-0.78|-2.88|<0.001
91666356|NCT00835081|183226604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|95.9|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||110|95.9|
91666357|NCT00835081|183226605|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.5|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|97.5|
91483810|NCT05419908|182841147|SUPERIORITY||LSMean difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week4: Overall Quality of Life||-0.97|-2.86|<0.001
91483811|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.51|||<|0.001|TWO_SIDED|95.0|-3.41|-1.61||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Quality of Life||-1.61|-3.41|<0.001
91483812|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.36|||<|0.001|TWO_SIDED|95.0|-3.31|-1.41||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Quality of Life||-1.41|-3.31|<0.001
91483813|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.73|-1.23||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Overall Mean Score||-1.23|-2.73|<0.001
91483814|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-2.21|||<|0.001|TWO_SIDED|95.0|-3.02|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Mean Score||-1.40|-3.02|<0.001
91483815|NCT05419908|182841147|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.83|-1.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Mean Score||-1.13|-2.83|<0.001
91483816|NCT05419908|182841148|SUPERIORITY||LSMean Difference|1.375|||<|0.001|TWO_SIDED|95.0|0.651|2.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Getting to Sleep||2.100|0.651|<0.001
91483817|NCT05419908|182841148|SUPERIORITY||LSMean Difference|1.166|||<|0.001|TWO_SIDED|95.0|0.505|1.827||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Getting to Sleep||1.827|0.505|<0.001
91483818|NCT05419908|182841148|SUPERIORITY||LSMean Difference|0.895||||0.014|TWO_SIDED|95.0|0.19|1.599||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Getting to Sleep||1.599|0.190|0.014
91483819|NCT05419908|182841148|SUPERIORITY||LSMean Difference|2.423|||<|0.001|TWO_SIDED|95.0|1.308|3.539||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Quality of Sleep||3.539|1.308|<0.001
91483820|NCT05419908|182841148|SUPERIORITY||LSMean Difference|2.291|||<|0.001|TWO_SIDED|95.0|1.31|3.251||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Quality of Sleep||3.251|1.31|<0.001
91483821|NCT05419908|182841148|SUPERIORITY||LSMean Difference|2.433|||<|0.001|TWO_SIDED|95.0|1.334|3.532||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Quality of Sleep||3.532|1.334|<0.001
91483822|NCT05419908|182841148|SUPERIORITY||LSMean Difference|0.877||||0.059|TWO_SIDED|95.0|-0.034|1.789||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Awake Following Sleep||1.789|-0.034|0.059
91483823|NCT05419908|182841148|SUPERIORITY||LSMean Difference|1.457||||0.001|TWO_SIDED|95.0|0.579|2.335||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Awake Following Sleep||2.335|0.579|0.001
91483824|NCT05419908|182841148|SUPERIORITY||LSMean Difference|1.113||||0.031|TWO_SIDED|95.0|0.107|2.12||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Awake Following Sleep||2.120|0.107|0.031
91483825|NCT05419908|182841148|SUPERIORITY||LSMean Difference|1.203||||0.008|TWO_SIDED|95.0|0.317|2.088||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Behaviour Following Wakening||2.088|0.317|0.008
91631933|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.94|||||TWO_SIDED|95.0|0.81|1.09|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.09|0.81|
91631934|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.8|1.22|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.22|0.80|
91631935|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.64|0.93|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.93|0.64|
91631936|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.67|0.9|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.90|0.67|
91631937|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.65|||||TWO_SIDED|95.0|0.55|0.75|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.75|0.55|
91631938|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.6|0.81|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.81|0.60|
91631939|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.8|1.04|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.04|0.80|
91666358|NCT00835081|183226606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|97.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||102|97.4|
91666359|NCT00874276|183226607|SUPERIORITY_OR_OTHER||Kendall's Tau-B|0.6|STANDARD_ERROR_OF_MEAN|0.127||0.023|TWO_SIDED|95.0|0.35|0.85||This is the primary outcome, and there is no adjustment.|Wilcoxon (Mann-Whitney)|||We used a Wilcoxon test (and accompanying Kendal's Tau B) because these outcomes are outlier prone.||0.85|0.35|0.023
91631940|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.42|||||TWO_SIDED|95.0|1.01|2.0|||||Comparison for Day 14, triglycerides|An estimation approach was used.||2.00|1.01|
91631941|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.94|1.75|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.75|0.94|
91631942|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.24|||||TWO_SIDED|95.0|0.98|1.58|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.58|0.98|
91631943|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.22|||||TWO_SIDED|95.0|0.95|1.56|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.56|0.95|
91631944|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.57|0.96|
91666360|NCT00874276|183226608|SUPERIORITY_OR_OTHER||Kendall's Tau B|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.42|TWO_SIDED|95.0|-0.23|0.69|||Wilcoxon (Mann-Whitney)|||This is the same analysis as the previous, except we use the day 5 pharmacogenetics on the amount of time needed to clear one-half of dose of the drug. This is for the environmental dose. A positive (negative) Kendall's Tau is associated with the EGT allele being faster (slower) than lacking EGT in terms of metabolization of DCA.||0.69|-0.23|0.42
91631945|NCT02202161|183156940|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.72|1.11|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.11|0.72|
91631946|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.87|1.11|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.11|0.87|
91631947|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|0.71|0.89|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.89|0.71|
91631948|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.90|0.74|
91631949|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.77|0.63|
91631950|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.85|0.70|
91483826|NCT05419908|182841148|SUPERIORITY||LSMean Difference|1.597||||0.001|TWO_SIDED|95.0|0.639|2.556||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Behaviour Following Wakening||2.556|0.639|0.001
91631951|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.89|1.06|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.06|0.89|
91631952|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.07|0.77|
91631953|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.81|||||TWO_SIDED|95.0|0.68|0.95|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.95|0.68|
91631954|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.7|0.91|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.91|0.70|
91483827|NCT05419908|182841148|SUPERIORITY||LSMean Difference|0.842||||0.084|TWO_SIDED|95.0|-0.116|1.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Behaviour Following Sleep||1.800|-0.116|0.084
91483828|NCT05419908|182841149|SUPERIORITY||LSMean Difference|0.0||||0.881|TWO_SIDED|95.0|-0.3|0.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Loss of Interest in Sex||0.3|-0.3|0.881
91631955|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.58|0.77|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.77|0.58|
91631956|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.83|0.64|
91631957|NCT02202161|183156941|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.8|1.02|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.02|0.80|
91666361|NCT05330975|183226631|NON_INFERIORITY|Lower bound of the 95% CI of GMR \>0.667, using a noninferiority margin of 1.5.|GMR|0.854|||||TWO_SIDED|95.0|0.728|1.002|||||mRNA-1345+Afluria group compared mRNA-1345 alone group|||1.002|0.728|
91666362|NCT05330975|183226632|NON_INFERIORITY|Lower bound of the 95% CI of the SRR difference \>-10%, using noninferiority margin of 10%.|Difference|-14.3|||||TWO_SIDED|95.0|-21.5|-6.9|||||mRNA-1345+Afluria group compared mRNA-1345 alone group|||-6.9|-21.5|
91483829|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-0.2||||0.383|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Loss of Interest in Sex||0.2|-0.6|0.383
91483830|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-0.2||||0.301|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Loss of Interest in Sex||0.2|-0.6|0.301
91483831|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-2.5||||0.02|TWO_SIDED|95.0|-4.5|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Psychological||-0.4|-4.5|0.020
91483832|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-3.3||||0.003|TWO_SIDED|95.0|-5.4|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Psychological||-1.2|-5.4|0.003
91631958|NCT03685643|183156947|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91631959|NCT03685643|183156948|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91631960|NCT03685643|183156949|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91631961|NCT03797144|183156951|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.06|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.06
91631962|NCT03797144|183156951|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.012
91666363|NCT05330975|183226640|NON_INFERIORITY|Lower bound of the 95% CI of GMR \>0.667, using a noninferiority margin of 1.5.|GMR|0.888|||||TWO_SIDED|95.0|0.791|0.995|||||mRNA-1345+mRNA-1273.214 compared with mRNA-1345 alone|||0.995|0.791|
91666364|NCT05330975|183226641|NON_INFERIORITY|Lower bound of the 95% CI of the SRR difference \>-10%, using noninferiority margin of 10%.|Difference|-5.9|||||TWO_SIDED|95.0|-11.9|0.3|||||mRNA-1345+mRNA-1273.214 compared with mRNA-1345 alone|||0.3|-11.9|
91666365|NCT05330975|183226664|NON_INFERIORITY|Lower bound of the 95% CI of geometric mean ratio (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.807|||||TWO_SIDED|95.0|0.668|0.974|||||mRNA-1345+Afluria group compared mRNA-1345 alone group|||0.974|0.668|
91631963|NCT03797144|183156952|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||0.002
91631964|NCT03797144|183156952|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
91631965|NCT03797144|183156952|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
91631966|NCT03797144|183156952|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
91631967|NCT03797144|183156953|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.174||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.174
91631968|NCT03797144|183156953|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.002
91631969|NCT03797144|183156953|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.003||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.003
91666366|NCT05330975|183226665|NON_INFERIORITY|Lower bound of the 95% CI of the SRR difference \>-10%, using noninferiority margin of 10%.|Difference|-11.2|||||TWO_SIDED|95.0|-17.9|-4.1|||||mRNA-1345+Afluria group compared mRNA-1345 alone group|||-4.1|-17.9|
91483833|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-3.1||||0.005|TWO_SIDED|95.0|-5.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Psychological||-1.0|-5.2|0.005
91483834|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-0.2||||0.732|TWO_SIDED|95.0|-1.2|0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Physical||0.9|-1.2|0.732
91483835|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-0.7||||0.282|TWO_SIDED|95.0|-1.9|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Physical||0.6|-1.9|0.282
91527818|NCT06173570|182930684|SUPERIORITY||Mean Difference (Net)|-27.14|||<|0.001|TWO_SIDED|95.0|-32.16|-22.11|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-22.11|-32.16|< 0.001
91666367|NCT05330975|183226666|NON_INFERIORITY|Lower bound of the 95% CI of GMR \>0.667, using a noninferiority margin of 1.5.|GMR|0.893|||||TWO_SIDED|95.0|0.772|1.032|||||mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group|Influenza A H1N1 Antibody||1.032|0.772|
91483836|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-0.6||||0.254|TWO_SIDED|95.0|-1.7|0.5||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Physical||0.5|-1.7|0.254
91483837|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.7|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Vasomotor||-1.4|-2.7|<0.001
91483838|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.4|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Vasomotor||-1.1|-2.4|<0.001
91631970|NCT03797144|183156953|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.012
91631971|NCT03299166|183156976|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.2202|TWO_SIDED|95.0|-2.59|0.6|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||0.60|-2.59|0.2202
91631972|NCT03299166|183156983|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.61||0.4508|TWO_SIDED|95.0|-1.67|0.75|||Mixed Models Analysis|||"Week 4 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||0.75|-1.67|0.4508
91631973|NCT03299166|183156983|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.75||0.041|TWO_SIDED|95.0|-3.02|-0.06|||Mixed Models Analysis|||"Week 8 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||-0.06|-3.02|0.0410
91631974|NCT03296072|183156990|OTHER||Difference of Least Square mean|7.69|||<|0.0001|TWO_SIDED|95.0|5.18|10.19|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||10.19|5.18|<.0001
91631975|NCT03296072|183156991|OTHER||Difference of Least Square mean|33.29|||<|0.0001|TWO_SIDED|95.0|28.89|37.68|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||37.68|28.89|<.0001
91631976|NCT03296072|183156992|OTHER||Difference of Least Square mean|1.81|||<|0.0001|TWO_SIDED|95.0|1.59|2.04|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||2.04|1.59|<.0001
91631977|NCT03296072|183156993|OTHER||Difference of Least Square mean|7.57|||<|0.0001|TWO_SIDED|95.0|5.07|11.07|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||11.07|5.07|<.0001
91631978|NCT03296072|183156994|OTHER||Difference of Least Square mean|10.98|||<|0.0001|TWO_SIDED|95.0|6.58|15.37|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||15.37|6.58|<.0001
91666368|NCT05330975|183226666|NON_INFERIORITY|Lower bound of the 95% CI of geometric mean ratio (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.969|||||TWO_SIDED|95.0|0.861|1.091|||||mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group|Influenza A H3N2 Antibody||1.091|0.861|
91666369|NCT05330975|183226666|NON_INFERIORITY|Lower bound of the 95% CI of geometric mean ratio (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.927|||||TWO_SIDED|95.0|0.822|1.045|||||mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group|Influenza B Washington Antibody||1.045|0.822|
91483839|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Vasomotor||-1.3|-2.6|<0.001
91483840|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-4.6||||0.013|TWO_SIDED|95.0|-8.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Total Symptom Score||-1.0|-8.2|0.013
91631979|NCT03296072|183156995|OTHER||Difference of Least Square mean|0.97|||<|0.0001|TWO_SIDED|95.0|0.75|1.2|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||1.20|0.75|<.0001
91631980|NCT01682759|183156999|NON_INFERIORITY_OR_EQUIVALENCE|Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.|Difference in the least squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||0.30|0.06|
91666370|NCT05330975|183226666|NON_INFERIORITY|Lower bound of the 95% CI of geometric mean ratio (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.909|||||TWO_SIDED|95.0|0.809|1.02|||||mRNA-1345+Afluria group at Day 29 compared with the GMT of anti-HA Ab in the Afluria alone group|Influenza B Phuket Antibody||1.020|0.809|
91483841|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-6.9|||<|0.001|TWO_SIDED|95.0|-10.7|-3.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Total Symptom Score||-3.1|-10.7|<0.001
91666371|NCT05330975|183226672|NON_INFERIORITY|Lower bound of the 95% CI of ratio of the GMT (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.796|||||TWO_SIDED|95.0|0.702|0.901|||||mRNA-1345+mRNA-1273.214 compared to mRNA-1345 alone|||0.901|0.702|
91666372|NCT05330975|183226673|NON_INFERIORITY|Lower bound of the 95% CI of the SRR difference \>-10%, using noninferiority margin of 10%.|Difference|-4.4|||||TWO_SIDED|95.0|-9.9|1.0|||||mRNA-1345+mRNA-1273.214 compared to mRNA-1345 alone|||1.0|-9.9|
91483842|NCT05419908|182841149|SUPERIORITY||LSMean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.9|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Total Symptom Score||-2.8|-9.9|<0.001
91483843|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.7|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Work/School||-0.8|-2.7|<0.001
91483844|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.8|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Work/School||-1.3|-2.8|<0.001
91483845|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Work/School||-0.8|-2.5|<0.001
91483846|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Social Life||-0.6|-2.2|<0.001
91525771|NCT03587142|182927088|SUPERIORITY||Mean Difference (Net)|-0.11||||0.69|TWO_SIDED|95.0|-0.68|0.45||Nominal P value. Power was determined at a level of P=0.05.|ANCOVA|Multiple imputation using regression and 50 datasets to estimate the outcome for the 18/96 (19%) randomized patients without the f4 visit data.||Primary outcome analysis uses a difference of differences analysis between Buspirone compared to the Placebo arm in which the adjusted mean difference of differences, Wald 95% Confidence interval and 2-sided P values are determined from a Wald Chi-Square test. Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Negative change indicates symptom improvement.||0.45|-0.68|0.69
91525772|NCT03587142|182927088|SUPERIORITY||Mean Difference (Net)|-0.13||||0.62|TWO_SIDED|95.0|-0.65|0.39||P value is nominal; no adjustments made from multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005.|ANCOVA|||Sensitivity analysis of change from a baseline in ES/PPF (Early Satiety/Postprandial Fullness subscore) using all completers: 39 participants in Buspirone arm, 39 participants in placebo arm.||0.39|-0.65|0.62
91631981|NCT01682759|183157000|SUPERIORITY_OR_OTHER||Difference in percentages|-6.9|||||TWO_SIDED|95.0|-13.9|0.1|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||0.1|-13.9|
91631982|NCT01682759|183157001|SUPERIORITY_OR_OTHER||Difference in percentages|1.1|||||TWO_SIDED|95.0|-1.6|3.8|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||3.8|-1.6|
91631983|NCT01682759|183157002|SUPERIORITY_OR_OTHER||Difference in the least squares means|5.6|||||TWO_SIDED|95.0|0.1|11.2|||||cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups|||11.2|0.1|
91631984|NCT01682759|183157003|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|-3.7|||||TWO_SIDED|95.0|-10.6|3.3|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \<6.5%||3.3|-10.6|
91666373|NCT05330975|183226674|NON_INFERIORITY|Lower bound of the 95% CI of ratio of the GMT (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.959|||||TWO_SIDED|95.0|0.872|1.056|||||mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone|GMR for Wuhan-Hu-1||1.056|0.872|
91483847|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Social Life||-1.1|-2.7|<0.001
91483848|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Social Life||-0.7|-2.4|<0.001
91483849|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Family Life/Home Responsibilities||-0.4|-2.2|0.005
91483850|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Family Life/Home Responsibilities||-0.9|-2.5|<0.001
91483851|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Family Life/Home Responsibilities||-0.7|-2.4|<0.001
91483852|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-6.9|-2.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Global Functional Impairment||-2.0|-6.9|<0.001
91483853|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-5.8|||<|0.001|TWO_SIDED|95.0|-8.0|-3.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Global Functional Impairment||-3.6|-8.0|<0.001
91483854|NCT05419908|182841150|SUPERIORITY||LSMean Difference|-5.3|||<|0.001|TWO_SIDED|95.0|-7.8|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Global Functional Impairment||-2.8|-7.8|<0.001
91666374|NCT05330975|183226674|NON_INFERIORITY|Lower bound of the 95% CI of ratio of the GMT (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|1.004|||||TWO_SIDED|95.0|0.888|1.137|||||mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone|GMR for B.1.1.529||1.137|0.888|
91666375|NCT05330975|183226675|NON_INFERIORITY|Lower bound of the 95% CI of the SRR difference \>-10%, using noninferiority margin of 10%.|Difference|0.2|||||TWO_SIDED|95.0|-6.0|6.3|||||mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone|SRR difference for Wuhan-Hu-1||6.3|-6.0|
91483855|NCT05419908|182841151|SUPERIORITY||LSMean difference|0.0||||0.936|TWO_SIDED|95.0|-0.5|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Lost||0.6|-0.5|0.936
91483856|NCT05419908|182841151|SUPERIORITY||LSMean difference|0.0||||0.884|TWO_SIDED|95.0|-0.1|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Lost||0.1|-0.1|0.884
91483857|NCT05419908|182841151|SUPERIORITY||LSMean difference|-0.2||||0.124|TWO_SIDED|95.0|-0.4|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Lost||0.1|-0.4|0.124
91631985|NCT01682759|183157004|SUPERIORITY_OR_OTHER||Difference in percentages|-21.3|||<|0.001|TWO_SIDED|95.0|-26.5|-16.4|||Difference in percentages||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||-16.4|-26.5|<0.001
91631986|NCT01682759|183157005|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Difference in the least squares means||cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.|||-1.4|-2.5|<0.001
91666376|NCT05330975|183226675|NON_INFERIORITY|Lower bound of the 95% CI of the SRR difference \>-10%, using noninferiority margin of 10%.|Difference|-0.9|||||TWO_SIDED|95.0|-6.6|4.7|||||mRNA-1345+mRNA-1273.214 compared to mRNA-1273.214 alone|SRR difference for B.1.1.529||4.7|-6.6|
91666377|NCT05330975|183226680|NON_INFERIORITY|Lower bound of the 95% CI of ratio of the GMT (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|1.077|||||TWO_SIDED|95.0|0.995|1.166|||||The 95% CI for the GMR is based on t-distribution of the log-transformed values then back transformed to the original scale for presentation.|GMR of RSV-A. GMR was calculated by back transforming the mean of paired difference of antibody levels on the logarithmic scale between revaccination Day 29 and primary vaccination Day 29.||1.166|0.995|
91483858|NCT05419908|182841151|SUPERIORITY||LSMean difference|-0.9||||0.052|TWO_SIDED|95.0|-1.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Unproductive||0.0|-1.8|0.052
91483859|NCT05419908|182841151|SUPERIORITY||LSMean difference|-0.9||||0.06||95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Unproductive||0.0|-1.7|0.060
91525773|NCT03587142|182927088|SUPERIORITY||Mean Difference (Net)|-0.25||||0.62|TWO_SIDED|95.0|-0.89|0.38||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Sensitivity analyses: change in ES/PPF in treatment adherent patients: 23 participants in Buspirone arm, 29 patients in placebo arm.||0.38|-0.89|0.62
91666378|NCT05330975|183226680|NON_INFERIORITY|Lower bound of the 95% CI of ratio of the GMT (GMR) \>0.667, using a noninferiority margin of 1.5.|GMR|0.909|||||TWO_SIDED|95.0|0.839|0.984|||||The 95% CI for the GMR is based on t-distribution of the log-transformed values then back transformed to the original scale for presentation.|GMR of RSV-B. GMR was calculated by back transforming the mean of paired difference of antibody levels on the logarithmic scale between revaccination Day 29 and primary vaccination Day 29.||0.984|0.839|
91483860|NCT05419908|182841151|SUPERIORITY||LSMean difference|-0.8||||0.049|TWO_SIDED|95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Unproductive||0.0|-1.7|0.049
91483861|NCT01298531|182841190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.27||||0.0019|TWO_SIDED|95.0|-44.17|-10.38|||ANCOVA|Not specifed.||The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.||-10.38|-44.17|0.0019
91483862|NCT01298531|182841191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.78||||0.0115|TWO_SIDED|95.0|-34.99|-4.57|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.||-4.57|-34.99|0.0115
91483863|NCT01298531|182841192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0153|TWO_SIDED|95.0|-1.68|-0.18|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.||-0.18|-1.68|0.0153
91483864|NCT01298531|182841193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.051|TWO_SIDED|95.0|-1.76|0.0|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.||0.00|-1.76|0.0510
91631987|NCT01682759|183157006|SUPERIORITY_OR_OTHER||Between-group Rate Difference|-10.3|||||TWO_SIDED|95.0|-17.8|-2.8|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \< 7.0%||-2.8|-17.8|
91631988|NCT02043704|183157012|EQUIVALENCE|The null hypothesis is that there is no difference in the pain scores between the groups.||||||0.328||||||The p-value was not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|There were no adjustments.||The comparison was analyzed using the Mann-Whitney U test.||||0.328
91631989|NCT03958149|183157036|SUPERIORITY||||||<|0.001|||||||Independent t-test|||||||<0.001
91631990|NCT03958149|183157037|SUPERIORITY||||||<|0.05|||||||Factorial Mixed ANOVA|||||||<0.05
91631991|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.3474|TWO_SIDED|95.0|-3.3|9.1|||ANOVA|Analysis of variance for repeated measures||Dryness - Study eye - Day 15±2 The model included fixed effect terms for time point, baseline covariate (i.e. the day 1 - pre-dose value) and treatment. Time point was specified as a repeated measurement.||9.1|-3.3|0.3474
91631992|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1327|TWO_SIDED|95.0|-8.2|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||4.3|-8.2|0.1327
91631993|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.1327|TWO_SIDED|95.0|-11.2|1.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||1.6|-11.2|0.1327
91483865|NCT01298531|182841195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209||||0.0066|TWO_SIDED|95.0|0.07|0.65|||Regression, Logistic|||Logistic regression with baseline score and treatment group included as covariates.||0.65|0.07|0.0066
91483866|NCT01298531|182841196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.7||||0.0053|TWO_SIDED|95.0|-91.01|-16.38|||ANCOVA|||The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.||-16.38|-91.01|0.0053
91483867|NCT01298531|182841197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.963||||0.0324|TWO_SIDED|95.0|1.1|8.01|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.01|1.10|0.0324
91483868|NCT01298531|182841200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0501|TWO_SIDED|95.0|1.0|7.27|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||7.27|1.00|0.0501
91483869|NCT01298531|182841202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.103||||0.0284|TWO_SIDED|95.0|1.13|8.54|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.54|1.13|0.0284
91483870|NCT01298531|182841204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.3291|TWO_SIDED|95.0|0.47|9.72|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||9.72|0.47|0.3291
91483871|NCT01298531|182841205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.44|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.44|-1.11|<0.0001
91483872|NCT01298531|182841206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0011|TWO_SIDED|95.0|-1.09|-0.28|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.28|-1.09|0.0011
91483873|NCT01298531|182841208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0011|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.24|-0.90|0.0011
91483874|NCT01298531|182841209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0037|TWO_SIDED|95.0|-1.11|-0.22|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.22|-1.11|0.0037
91525774|NCT03587142|182927089|SUPERIORITY||Mean Difference (Net)|-0.09||||0.76|TWO_SIDED|95.0|-0.69|0.5||Nominal P value reported. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||The mean difference of differences (DoD) between Buspirone and Placebo, 95% confidence interval and P (2-sided) were derived from an ANCOVA, regressing an indicator for treatment group on fullness severity score, adjusting for the baseline value of fullness severity score.||0.50|-0.69|0.76
91483875|NCT01298531|182841213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.40|-2.20|0.0050
91483876|NCT01298531|182841214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0256|TWO_SIDED|95.0|-2.33|-0.16|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.16|-2.33|0.0256
91483877|NCT01298531|182841216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0474|TWO_SIDED|95.0|-2.0|-0.01|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.||-0.01|-2.00|0.0474
91483878|NCT01298531|182841217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0212|TWO_SIDED|95.0|-2.36|-0.2|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor||-0.20|-2.36|0.0212
91483879|NCT01298531|182841219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0198|TWO_SIDED|95.0|-2.4|-0.21|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.21|-2.40|0.0198
91483880|NCT01298531|182841220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0132|TWO_SIDED|95.0|-2.69|-0.32|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.32|-2.69|0.0132
91483881|NCT01298531|182841222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0237|TWO_SIDED|95.0|-1.5|-0.11|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.11|-1.50|0.0237
91483882|NCT01298531|182841223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.0297|TWO_SIDED|95.0|-1.74|-0.09|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.09|-1.74|0.0297
91666379|NCT01167829|183226706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|183.0|STANDARD_ERROR_OF_MEAN|44.0||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
91666380|NCT00834444|183226716|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.9||||||90.0|87.8|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|87.8|
91666381|NCT00834444|183226717|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.9|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.9|
91666382|NCT00834444|183226718|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.7|
91483883|NCT01298531|182841224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.0152|TWO_SIDED|95.0|-2.09|-0.23|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.23|-2.09|0.0152
91483884|NCT01298531|182841225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.0344|TWO_SIDED|95.0|-2.22|-0.09|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.09|-2.22|0.0344
91483885|NCT01298531|182841227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0017|TWO_SIDED|95.0|-2.16|-0.52|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor||-0.52|-2.16|0.0017
91483886|NCT01298531|182841228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0233|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.||-0.16|-2.07|0.0233
91525775|NCT03587142|182927090|SUPERIORITY||Mean Difference (Net)|-0.15||||0.64|TWO_SIDED|95.0|-0.76|0.47||Nominal P values; Bonferroni p value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.47|-0.76|0.64
91525776|NCT03587142|182927091|SUPERIORITY||Mean Difference (Net)|-0.14||||0.66|TWO_SIDED|95.0|-0.79|0.5||P values are nominal; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.50|-0.79|0.66
91525777|NCT03587142|182927092|SUPERIORITY||Mean Difference (Net)|-0.12||||0.7|TWO_SIDED|95.0|-0.75|0.5||Nominal P values; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (s-sided) determined from a Wald Chi-Square test.||0.50|-0.75|0.70
91631994|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.2237|TWO_SIDED|95.0|-2.5|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||10.0|-2.5|0.2237
91631995|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.4905|TWO_SIDED|95.0|-8.4|4.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||4.1|-8.4|0.4905
91631996|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.0687|TWO_SIDED|95.0|-12.3|0.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||0.5|-12.3|0.0687
91631997|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.7609|TWO_SIDED|95.0|-4.2|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||5.6|-4.2|0.7609
91631998|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.6428|TWO_SIDED|95.0|-6.0|3.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.8|-6.0|0.6428
91631999|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.2|-6.9|0.4599
91666383|NCT00841659|183226744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|99.96||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
91483887|NCT01298531|182841237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.126|TWO_SIDED|95.0|0.822|4.901|||Regression, Logistic|||Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.||4.901|0.822|0.1260
91483888|NCT01298531|182841240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0498|TWO_SIDED|95.0|1.0|6.08|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.||6.08|1.00|0.0498
91483889|NCT01298531|182841242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1601|TWO_SIDED|95.0|-0.87|0.15|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.15|-0.87|0.1601
91483890|NCT01298531|182841243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2967|TWO_SIDED|95.0|-0.86|0.27|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.27|-0.86|0.2967
91483891|NCT01298531|182841249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41||||0.2735|TWO_SIDED|95.0|-1.94|6.75|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||6.75|-1.94|0.2735
91483892|NCT01298531|182841250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.0422|TWO_SIDED|95.0|0.02|1.34|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||1.34|0.02|0.0422
91632000|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.4217|TWO_SIDED|95.0|-4.6|10.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||10.5|-4.6|0.4217
91632001|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.503||||-2.5|TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||5.0|-10.0|-2.5
91632002|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||3.2|-6.9|0.4599
91632003|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.6157|TWO_SIDED|95.0|-2.6|4.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||4.4|-2.6|0.6157
91483893|NCT02360995|182841268|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.652
91483894|NCT02360995|182841269|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91483895|NCT02360995|182841270|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91483896|NCT02360995|182841271|SUPERIORITY_OR_OTHER|||||||0.533|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.533
91483897|NCT02360995|182841272|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91483898|NCT02360995|182841273|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91483899|NCT04622735|182841295|SUPERIORITY|||||||0.0031|||||||Mixed Models Analysis|||||||0.0031
91527819|NCT06173570|182930684|SUPERIORITY||Mean Difference (Net)|-29.36|||<|0.001|TWO_SIDED|95.0|-34.4|-24.31|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-24.31|-34.40|< 0.001
91632004|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.912|TWO_SIDED|95.0|-3.7|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||3.3|-3.7|0.9120
91632005|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.5463|TWO_SIDED|95.0|-4.6|2.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||2.5|-4.6|0.5463
91632006|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9065|TWO_SIDED|95.0|-5.9|5.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||5.3|-5.9|0.9065
91632007|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.5065|TWO_SIDED|95.0|-7.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||3.7|-7.3|0.5065
91632008|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.5977|TWO_SIDED|95.0|-7.1|4.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||4.2|-7.1|0.5977
91483900|NCT04622735|182841295|SUPERIORITY|||||||0.6787|||||||Mixed Models Analysis|||||||0.6787
91483901|NCT02476422|182841315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2||||0.211|TWO_SIDED|95.0|-1.8|8.3|||ANCOVA|||||8.3|-1.8|0.211
91483902|NCT00994318|182841328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.026|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||0.95|0.44|0.026
91483903|NCT00994318|182841328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.082|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||1.05|0.45|0.082
91483904|NCT00994318|182841328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.39|0.93|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.93|0.39|0.020
91483905|NCT00994318|182841328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.008|TWO_SIDED|95.0|0.43|0.88|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.88|0.43|0.008
91483906|NCT00994318|182841328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.1|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)"||1.10|0.45|0.12
91483907|NCT02545075|182841335|SUPERIORITY|||||||0.5059|||||||Chi-squared|One-sided p-value based on unstratified chi-square test||||||0.5059
91632009|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.2785|TWO_SIDED|95.0|-6.3|1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred Vision - Study eye - Day 15±2||1.9|-6.3|0.2785
91483908|NCT02545075|182841336|SUPERIORITY|||||||0.6202|||||||Chi-squared|One-sided unstratified chi-square||||||0.6202
91483909|NCT02545075|182841337|SUPERIORITY||Stratified cox proportional hazard model|1.13||||0.7267|TWO_SIDED|80.0|0.87|1.45|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)||||1.45|0.87|0.7267
91483910|NCT02545075|182841338|SUPERIORITY||Stratified Cox proportional hazard|0.9||||0.2503|TWO_SIDED|80.0|0.71|1.15|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS||||1.15|0.71|0.2503
91483911|NCT02545075|182841339|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|80.0|0.64|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.64|0.9932
91483912|NCT02545075|182841340|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9738|TWO_SIDED|80.0|0.48|2.03|||Cochran-Mantel-Haenszel|||||2.03|0.48|0.9738
91483913|NCT06400979|182841362|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
91483914|NCT06400979|182841363|SUPERIORITY|To assess the reduction of nausea following aromatherapy, pre- and post- aromatherapy scores were compared using paired t-tests||||||0.13|||||||ANCOVA|||||||0.13
91632010|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.7454|TWO_SIDED|95.0|-4.6|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||3.3|-4.6|0.7454
91632011|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4588|TWO_SIDED|95.0|-2.7|5.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||5.9|-2.7|0.4588
91632012|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.2812|TWO_SIDED|95.0|-3.7|12.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||12.3|-3.7|0.2812
91632013|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6811|TWO_SIDED|95.0|-6.5|9.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||9.8|-6.5|0.6811
91632014|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5169|TWO_SIDED|95.0|-10.8|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||5.6|-10.8|0.5169
91666384|NCT00841659|183226745|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|93.58||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
91666385|NCT00841659|183226746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.29||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
91666386|NCT03499873|183226748|EQUIVALENCE|90% CI on the Test-to-Reference difference for the proportion of subjects with cure should be contained within the interval \[-0.20, +0.20\]|Mean Difference (Net)|-0.026|||||TWO_SIDED|90.0|-0.124|0.073||||||||0.073|-0.124|
91483915|NCT06400979|182841364|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91483916|NCT06400979|182841365|OTHER|Perceived effectiveness of aromatherapy for patient satisfaction were compared with respect to post-aromatherapy scores and pre-post changes in scores using two-sample t-tests||||||0.02|TWO_SIDED|73.4|||||t-test, 2 sided|||||||0.02
91483917|NCT06400979|182841366|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
91483918|NCT06400979|182841367|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
91483919|NCT02343081|182841379|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the ratio of the mean for Cmax for Temozolomide reference and test to fall within the 80-125% confidence range.|Cmax|94.37|||<|0.05|TWO_SIDED|90.0|82.69|107.69|||ANOVA|Primary parameters were analyzed using ANOVA. A linear, mixed model for crossover designs (two-period, two-sequence, two-treatment) was used.|Cmax Test/Reference Ratio|Bioequivalence assessment was made for the 90% CI for the ratio of log transformed pharmacokinetic parameters μT / μR and with the two one-sided Schuirmann T-test procedure under the null hypothesis||107.69|82.69|<0.05
91483920|NCT02343081|182841383|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-t for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-t|100.99|||<|0.05|TWO_SIDED|90.0|97.81|104.28|||ANOVA||AUC0-t Test/Reference Ratio|||104.28|97.81|<0.05
91632015|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.7874|TWO_SIDED|95.0|-5.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||7.8|-5.9|0.7874
91632016|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.8299|TWO_SIDED|95.0|-7.6|6.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||6.1|-7.6|0.8299
91632017|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.6386|TWO_SIDED|95.0|-8.7|5.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||5.4|-8.7|0.6386
91632018|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.0132|TWO_SIDED|95.0|1.3|10.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||10.2|1.3|0.0132
91632019|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.7177|TWO_SIDED|95.0|-5.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||3.7|-5.3|0.7177
91632020|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.0077|TWO_SIDED|95.0|-11.2|-1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||-1.9|-11.2|0.0077
91632021|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.0301|TWO_SIDED|95.0|0.6|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||10.0|0.6|0.0301
91632022|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8657|TWO_SIDED|95.0|-4.3|5.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||5.1|-4.3|0.8657
91666387|NCT03499873|183226748|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
91666388|NCT03499873|183226748|SUPERIORITY|||||||0.0003|||||||ANOVA|||||||0.0003
91666389|NCT00577655|183226762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.496||||0.0138|TWO_SIDED|95.0|0.729|6.262||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||6.262|0.729|0.0138
91483921|NCT02343081|182841384|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-inf for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-inf|101.53|||<|0.05|TWO_SIDED|90.0|98.6|104.54|||ANOVA||AUC0-inf Test/Reference Ratio|||104.54|98.60|<0.05
91483922|NCT00277446|182841426|SUPERIORITY_OR_OTHER||||||<|0.03||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||<0.03
91483923|NCT00277446|182841427|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.02
91632023|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.044|TWO_SIDED|95.0|-9.7|-0.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||-0.1|-9.7|0.0440
91632024|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1351|TWO_SIDED|95.0|-1.4|9.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||9.6|-1.4|0.1351
91483924|NCT00277446|182841428|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.88
91483925|NCT01680887|182841429|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
91483926|NCT00573248|182841431|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
91483927|NCT00573248|182841432|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED||||||ANOVA|||2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA||||<0.025
91525778|NCT03587142|182927093|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.66|0.27||P value is nominal; no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. P (2-sided) were determined from a Wald Chi-Square test.||0.27|-0.66|0.40
91632025|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.8821|TWO_SIDED|95.0|-6.0|5.2|||ANCOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||5.2|-6.0|0.8821
91632026|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.1208|TWO_SIDED|95.0|-10.3|1.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||1.3|-10.3|0.1208
91632027|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.944|TWO_SIDED|95.0|-3.3|3.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||3.5|-3.3|0.9440
91632028|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.4903|TWO_SIDED|95.0|-2.2|4.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.5|-2.2|0.4903
91714321|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.09||0.6895||95.0|-19.2|12.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.7|-19.2|0.6895
91632029|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.5364|TWO_SIDED|95.0|-2.3|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.3|-2.3|0.5364
91483928|NCT00573248|182841433|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
91483929|NCT00573248|182841434|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
91483930|NCT02536833|182841440|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.575|TWO_SIDED|95.0|-6.57|3.65|||ANCOVA|||||3.65|-6.57|0.575
91483931|NCT02536833|182841440|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.643|TWO_SIDED|95.0|-6.63|4.09|||ANCOVA|||||4.09|-6.63|0.643
91483932|NCT02536833|182841440|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.901|TWO_SIDED|95.0|-5.07|5.75|||ANCOVA|||||5.75|-5.07|0.901
91483933|NCT02536833|182841441|SUPERIORITY||Mean Difference (Final Values)|-2.99||||0.271|TWO_SIDED|95.0|-8.31|2.33|||ANCOVA|||||2.33|-8.31|0.271
91632030|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.51|TWO_SIDED|95.0|-2.9|5.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||5.7|-2.9|0.5100
91632031|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.1132|TWO_SIDED|95.0|-0.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||7.8|-0.9|0.1132
91483934|NCT02536833|182841441|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.898|TWO_SIDED|95.0|-6.06|5.32|||ANCOVA|||||5.32|-6.06|0.898
91483935|NCT02536833|182841441|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.795|TWO_SIDED|95.0|-4.74|6.18|||ANCOVA|||||6.18|-4.74|0.795
91483936|NCT02536833|182841442|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.283|TWO_SIDED|95.0|-7.74|2.26|||ANCOVA|||||2.26|-7.74|0.283
91483937|NCT02536833|182841442|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.588|TWO_SIDED|95.0|-6.82|3.86|||ANCOVA|||||3.86|-6.82|0.588
91483938|NCT02536833|182841442|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.853|TWO_SIDED|95.0|-5.76|4.76|||ANCOVA|||||4.76|-5.76|0.853
91483939|NCT02536833|182841443|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.292|TWO_SIDED|95.0|-8.26|2.49|||ANCOVA|||||2.49|-8.26|0.292
91483940|NCT02536833|182841443|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.931|TWO_SIDED|95.0|-5.34|5.83|||ANCOVA|||||5.83|-5.34|0.931
91483941|NCT02536833|182841443|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.878|TWO_SIDED|95.0|-4.92|5.76|||ANCOVA|||||5.76|-4.92|0.878
91483942|NCT02536833|182841444|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.648|TWO_SIDED|95.0|-3.83|6.16|||ANCOVA|||||6.16|-3.83|0.648
91483943|NCT02536833|182841444|SUPERIORITY||Mean Difference (Final Values)|-3.14||||0.209|TWO_SIDED|95.0|-8.02|1.75|||ANCOVA|||||1.75|-8.02|0.209
91483944|NCT02536833|182841444|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.915|TWO_SIDED|95.0|-4.78|5.33|||ANCOVA|||||5.33|-4.78|0.915
91483945|NCT02536833|182841445|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.969|TWO_SIDED|95.0|-5.16|5.36|||ANCOVA|||||5.36|-5.16|0.969
91483946|NCT02536833|182841445|SUPERIORITY||Mean Difference (Final Values)|-3.64||||0.174|TWO_SIDED|95.0|-8.89|1.61|||ANCOVA|||||1.61|-8.89|0.174
91632032|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3457|TWO_SIDED|95.0|-2.4|6.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||6.5|-2.4|0.3457
91792438|NCT02047318|183462628|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores from baseline over time (to Week 158) was statistically significant.|Mean Difference (Net)|-0.958|STANDARD_DEVIATION|0.7868||0.0307|TWO_SIDED|95.0|-1.784|-0.132||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 158 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed over time (with Week 158 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-0.132|-1.784|0.0307
91632033|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.0185|TWO_SIDED|95.0|0.8|7.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.9|0.8|0.0185
91632034|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.0408|TWO_SIDED|95.0|0.2|7.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.1|0.2|0.0408
91632035|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.6992|TWO_SIDED|95.0|-4.4|3.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||3.0|-4.4|0.6992
91632036|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.0905|TWO_SIDED|95.0|-1.0|12.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||12.8|-1.0|0.0905
91632037|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.3054|TWO_SIDED|95.0|-3.4|10.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||10.4|-3.4|0.3054
91632038|NCT03031327|183157056|SUPERIORITY||Mean Difference (Final Values)|0.5024||||0.5024|TWO_SIDED|95.0|-9.6|4.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||4.8|-9.6|0.5024
91632039|NCT03031327|183157058|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1226|TWO_SIDED|95.0|-0.1|0.8|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.8|-0.1|0.1226
91632040|NCT03031327|183157058|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.2854|TWO_SIDED|95.0|-0.2|0.7|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.7|-0.2|0.2854
91632041|NCT03031327|183157058|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6525|TWO_SIDED|95.0|-0.6|0.4|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Student t-test on changes from baseline in ocular surface vital staining - Study eye - Day 15±2 pre-dose||0.4|-0.6|0.6525
91632042|NCT03031327|183157058|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8843|TWO_SIDED|95.0|-0.4|0.5|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Non Study eye - Day 15±2 pre-dose||0.5|-0.4|0.8843
91714322|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|8.21||0.0209||95.0|-35.2|-2.9|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.9|-35.2|0.0209
91632043|NCT03031327|183157058|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0806|TWO_SIDED|95.0|-0.6|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.6|0.0806
91632044|NCT03031327|183157058|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0628|TWO_SIDED|95.0|-0.7|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.7|0.0628
91632045|NCT03031327|183157059|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.2004|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.9|-0.2|0.2004
91632046|NCT03031327|183157059|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5413|TWO_SIDED|95.0|-0.3|0.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.6|-0.3|0.5413
91632047|NCT03031327|183157059|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.4607|TWO_SIDED|95.0|-0.8|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.4|-0.8|0.4607
91632048|NCT03031327|183157059|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1248|TWO_SIDED|95.0|-0.2|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.4|-0.2|0.1248
91632049|NCT03031327|183157059|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0624|TWO_SIDED|95.0|0.0|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.1|0.0|0.0624
91632050|NCT03031327|183157059|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7927|TWO_SIDED|95.0|-1.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||0.8|-1.0|0.7927
91632051|NCT03031327|183157060|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9717|TWO_SIDED|95.0|-0.6|0.7|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.7|-0.6|0.9717
91632052|NCT03031327|183157060|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7386|TWO_SIDED|95.0|-0.6|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Study eye - Day 15±2 pre-dose||0.9|-0.6|0.7386
91632053|NCT03031327|183157060|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7498|TWO_SIDED|95.0|-0.6|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.8|-0.6|0.7498
91483947|NCT02536833|182841445|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.908|TWO_SIDED|95.0|-4.97|5.59|||ANCOVA|||||5.59|-4.97|0.908
91483948|NCT02536833|182841446|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.334|TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||||0.29|-0.10|0.334
91483949|NCT02536833|182841446|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.124|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|||||0.30|-0.04|0.124
91483950|NCT02536833|182841446|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.032|TWO_SIDED|95.0|0.02|0.36|||ANCOVA|||||0.36|0.02|0.032
91483951|NCT02536833|182841447|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.405|TWO_SIDED|95.0|-8.0|3.24|||ANCOVA|||||3.24|-8.00|0.405
91483952|NCT02536833|182841447|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.552|TWO_SIDED|95.0|-4.37|8.16|||ANCOVA|||||8.16|-4.37|0.552
91525779|NCT03587142|182927093|SUPERIORITY||Odds Ratio (OR)|1.31||||0.56|TWO_SIDED|95.0|0.53|3.21||Nominal P value without adjustment for multiple comparisons. Bonferroni threshold for level of significance is \<0.002.|Regression, Logistic|Odds ratio, 95% C.I. and P (two-sided) from a logistic regression of the binary outcome on treatment group for symptomatic improvement in GCSI.||GCSI symptomatic improvement of 1+ points in total GCSI symptom score defined as change in GCSI total score at week 4 from baseline being a decrease of 1 or more points. This is a binary variable where 1=1+ reduction in change in GCSI total score, 0=change in GCSI total score from baseline at 4-weeks is \< 1.0.||3.21|0.53|0.56
91632054|NCT03031327|183157060|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.3229|TWO_SIDED|95.0|-1.1|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.4|-1.1|0.3229
91632055|NCT03031327|183157060|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.57|TWO_SIDED|95.0|-0.5|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.9|-0.5|0.5700
91666390|NCT00577655|183226763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431||||0.0403|TWO_SIDED|95.0|0.244|10.618||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||10.618|0.244|0.0403
91483953|NCT02536833|182841447|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.763|TWO_SIDED|95.0|-4.91|6.68|||ANCOVA|||||6.68|-4.91|0.763
91483954|NCT02536833|182841448|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.173|TWO_SIDED|95.0|-9.5|1.71|||ANCOVA|||||1.71|-9.50|0.173
91483955|NCT02536833|182841448|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.724|TWO_SIDED|95.0|-5.12|7.36|||ANCOVA|||||7.36|-5.12|0.724
91483956|NCT02536833|182841448|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.914|TWO_SIDED|95.0|-6.17|5.53|||ANCOVA|||||5.53|-6.17|0.914
91525780|NCT03587142|182927094|SUPERIORITY||Mean Difference (Net)|-0.05||||0.86|TWO_SIDED|95.0|-0.58|0.48||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Squares test.||0.48|-0.58|0.86
91632056|NCT03031327|183157060|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1197|TWO_SIDED|95.0|-0.2|1.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||1.3|-0.2|0.1197
91632057|NCT03031327|183157061|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8787|TWO_SIDED|95.0|-0.6|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.6|0.8787
91632058|NCT03031327|183157061|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8159|TWO_SIDED|95.0|-0.5|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.7|-0.5|0.8159
91483957|NCT02536833|182841449|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.12|0.24|||ANCOVA|||||0.24|-0.12|0.529
91483958|NCT02536833|182841449|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.259|TWO_SIDED|95.0|-0.08|0.28|||ANCOVA|||||0.28|-0.08|0.259
91483959|NCT02536833|182841449|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.807|TWO_SIDED|95.0|-0.21|0.16|||ANCOVA|||||0.16|-0.21|0.807
91483960|NCT02536833|182841450|SUPERIORITY||Mean Difference (Final Values)|-8.73||||0.049|TWO_SIDED|95.0|-17.44|-0.03|||ANCOVA|||||-0.03|-17.44|0.049
91483961|NCT02536833|182841450|SUPERIORITY||Mean Difference (Final Values)|-6.03||||0.211|TWO_SIDED|95.0|-15.49|3.43|||ANCOVA|||||3.43|-15.49|0.211
91483962|NCT02536833|182841450|SUPERIORITY||Mean Difference (Final Values)|-5.23||||0.254|TWO_SIDED|95.0|-14.24|3.78|||ANCOVA|||||3.78|-14.24|0.254
91483963|NCT02536833|182841451|SUPERIORITY||Mean Difference (Final Values)|-10.26||||0.036|TWO_SIDED|95.0|-19.82|-0.69|||ANCOVA|||||-0.69|-19.82|0.036
91483964|NCT02536833|182841451|SUPERIORITY||Mean Difference (Final Values)|-7.07||||0.17|TWO_SIDED|95.0|-17.18|3.05|||ANCOVA|||||3.05|-17.18|0.170
91483965|NCT02536833|182841451|SUPERIORITY||Mean Difference (Final Values)|-6.29||||0.171|TWO_SIDED|95.0|-15.33|2.74|||ANCOVA|||||2.74|-15.33|0.171
91483966|NCT02536833|182841452|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.021|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||||0.72|0.06|0.021
91483967|NCT02536833|182841452|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.131|TWO_SIDED|95.0|-0.07|0.55|||ANCOVA|||||0.55|-0.07|0.131
91483968|NCT02536833|182841452|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.789|TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||||0.26|-0.35|0.789
91632059|NCT03031327|183157061|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6525|TWO_SIDED|95.0|-0.4|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.4|0.6525
91632060|NCT03031327|183157061|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.4|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.4|-1.0|0.3340
91483969|NCT00910988|182841457|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This p-value corresponds to the two way interaction between time and order and is not adjusted for multiple comparisons. The a priori threshold for statistical significance is alpha equal to 0.05. There was no 3 way interaction.|ANCOVA|Repeated measures ANCOVA with time as the repeated measure, drug assignment as a fixed factor, and order as a fixed factor.||The hypothesis being tested is whether there is a significant effect of one or both antipsychotics on whole body insulin sensitivity. Sample size was calculated using power calculations to detect significant effects of treatment on insulin sensitivity. Drug assignment is a 2-level fixed factor (olanzapine vs ziprasidone) as is order (drug first vs placebo first). Baseline of the dependent variable as well as baseline DEXA total fat were entered into the model as covariates.||||0.001
91483970|NCT00910988|182841460|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||This p-value corresponds to the 3 way interaction between time, drug (olanzapine vs ziprasidone), and order (drug first vs placebo first) and is not adjusted for multiple comparisons.|ANCOVA|||The null hypothesis is that olanzapine and ziprasidone would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue, which was measured by evaluating the rate of appearance of labeled glycerol. The alternative hypothesis is that olanzapine, but not ziprasidone, would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue.||||0.57
91632061|NCT03031327|183157061|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9749|TWO_SIDED|95.0|-0.7|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.7|-0.7|0.9749
91632062|NCT03031327|183157061|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.1984|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.9|-0.2|0.1984
91632063|NCT03031327|183157062|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.6497|TWO_SIDED|95.0|-10.5|16.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||16.4|-10.5|0.6497
91632064|NCT03031327|183157062|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.1443|TWO_SIDED|95.0|-16.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||2.6|-16.5|0.1443
91632065|NCT03031327|183157062|SUPERIORITY||Mean Difference (Final Values)|-9.9||||0.0751|TWO_SIDED|95.0|-20.9|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||1.1|-20.9|0.0751
91632066|NCT03031327|183157062|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.5015|TWO_SIDED|95.0|-7.9|15.5|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||15.5|-7.9|0.5015
91632067|NCT03031327|183157062|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.3217|TWO_SIDED|95.0|-12.5|4.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||4.4|-12.5|0.3217
91632068|NCT03031327|183157062|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.1026|TWO_SIDED|95.0|-17.5|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||1.8|-17.5|0.1026
91632069|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
91632070|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
91632071|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
91632072|NCT03031327|183157063|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
91632073|NCT03031327|183157063|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
91483971|NCT02766465|182841462|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the first year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||<0.001
91527490|NCT02597933|182930148|OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.76||0.5668|TWO_SIDED|95.0|-1.94|1.06|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.06|-1.94|0.5668
91632074|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||1.000
91632075|NCT03031327|183157063|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
91632076|NCT03031327|183157063|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
91632077|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||1.000
91632078|NCT03031327|183157063|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
91632079|NCT03031327|183157063|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
91714323|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|8.18||0.4084||95.0|-22.9|9.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.9|0.4084
91483972|NCT02766465|182841462|SUPERIORITY|||||||0.027||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing significant cerebrovascular event between two biologically assigned arms during the first year after biologic assignment. Significant cerebrovascular event includes stroke, transient ischemic attack, and seizure. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||0.027
91483973|NCT02766465|182841462|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe Vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the second year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the second year after assignment.||||< 0.001
91483974|NCT02766465|182841463|SUPERIORITY|||||||0.869||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 6MWD from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.869
91483975|NCT02766465|182841464|SUPERIORITY|||||||0.636||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TRJV from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.636
91483976|NCT02766465|182841466|SUPERIORITY|||||||0.242||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Physical Function changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.242
91483977|NCT02766465|182841467|SUPERIORITY|||||||0.343||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Anxiety changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.343
91525781|NCT03587142|182927095|SUPERIORITY||Mean Difference (Net)|-0.06||||0.85|TWO_SIDED|95.0|-0.64|0.53||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald-Chi Square test.||0.53|-0.64|0.85
91632080|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||1.000
91632081|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
91483978|NCT02766465|182841468|SUPERIORITY|||||||0.491||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Depression changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.491
91483979|NCT02766465|182841469|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing fatigue score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
91483980|NCT02766465|182841470|SUPERIORITY|||||||0.594||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Sleep Disturbance changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.594
91483981|NCT02766465|182841471|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing social roles score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
91483982|NCT02766465|182841472|SUPERIORITY|||||||0.071||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing pain interference score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.071
91632082|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
91632083|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
91632084|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
91632085|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
91714324|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|7.96||0.3958||95.0|-22.5|8.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.9|-22.5|0.3958
91632086|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
91632087|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
91632088|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
91632089|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
91483983|NCT02766465|182841473|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.146
91483984|NCT02766465|182841474|SUPERIORITY|||||||0.649||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 28-Day Pain Diary Average Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.649
91632090|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
91632091|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
91632092|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
91632093|NCT03031327|183157063|SUPERIORITY|||||||0.5267|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.5267
91632094|NCT03031327|183157063|SUPERIORITY|||||||0.2633|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.2633
91632095|NCT03031327|183157063|SUPERIORITY|||||||0.6552|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.6552
91632096|NCT03031327|183157063|SUPERIORITY|||||||0.1262|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.1262
91632097|NCT03031327|183157063|SUPERIORITY|||||||0.2094|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.2094
91632098|NCT03031327|183157063|SUPERIORITY||Hodges Lehmann estimation|-1.0||||0.0377|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||0.0|-1.0|0.0377
91632099|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
91632100|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
91632101|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
91632102|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
91632103|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
91632104|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
91632105|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
91632106|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
91632107|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
91632108|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
91666391|NCT00577655|183226764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.536||||0.0031|TWO_SIDED|95.0|1.567|7.505||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||7.505|1.567|0.0031
91666392|NCT00577655|183226764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.067||||0.047|TWO_SIDED|95.0|0.041|6.094||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||6.094|0.041|0.0470
91632109|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
91483985|NCT02766465|182841475|SUPERIORITY|||||||0.207||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ASCQ-Me Stiffness changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.207
91483986|NCT02766465|182841476|SUPERIORITY|||||||0.596||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1 changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.596
91483987|NCT02766465|182841477|SUPERIORITY|||||||0.684||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.684
91483988|NCT02766465|182841478|SUPERIORITY|||||||0.863||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1/FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.863
91483989|NCT02766465|182841479|SUPERIORITY|||||||0.455||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing VC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.455
91483990|NCT02766465|182841480|SUPERIORITY|||||||0.767||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TLC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.767
91483991|NCT02766465|182841481|SUPERIORITY|||||||0.241||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing RV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.241
91525782|NCT03587142|182927096|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.76|0.47||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test||0.47|-0.76|0.65
91632110|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
91483992|NCT02766465|182841482|SUPERIORITY|||||||0.268||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ERV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.268
91483993|NCT02766465|182841483|SUPERIORITY||||||>|0.999||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing IC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||>0.999
91483994|NCT02766465|182841484|SUPERIORITY|||||||0.832||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FRC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.832
91483995|NCT02766465|182841485|SUPERIORITY|||||||0.37||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing DLCO changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.370
91483996|NCT02766465|182841486|SUPERIORITY|||||||0.094||||||Statistical significance was determined using a pre-specified threshold of 0.05;|Wilcoxon (Mann-Whitney)|||This is the result comparing oxygen saturation changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.094
91483997|NCT02766465|182841488|SUPERIORITY|||||||0.313||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD in patients who received different donor type at transplant||||0.313
91483998|NCT02766465|182841489|SUPERIORITY|||||||0.233||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD in patients who received different donor type at transplant||||0.233
91483999|NCT01907100|182841491|OTHER||Hazard Ratio (HR)|0.555||||0.0174|TWO_SIDED|95.0|0.34|0.907|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II Part||0.907|0.340|0.0174
91632111|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
91632112|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
91632113|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
91484000|NCT01907100|182841491|OTHER||Hazard Ratio (HR)|1.01||||0.543|TWO_SIDED|95.0|0.79|1.3||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III part:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.30|0.79|0.5430
91632114|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
91632115|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
91632116|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
91632117|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
91632118|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
91632119|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
91632120|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
91632121|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
91632122|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
91666393|NCT00577655|183226765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.572||||0.0074|TWO_SIDED|95.0|2.077|13.067||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||13.067|2.077|0.0074
91666394|NCT00577655|183226765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.782||||0.1843|TWO_SIDED|95.0|-1.832|9.397||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||9.397|-1.832|0.1843
91632123|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
91632124|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
91666395|NCT00577655|183226766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.707||||0.0507|TWO_SIDED|95.0|-0.03|19.445||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||19.445|-0.030|0.0507
91632125|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
91632126|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
91632127|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
91632128|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
91632129|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
91632130|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
91632131|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
91632132|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
91632133|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
91632134|NCT03031327|183157063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
91632135|NCT03031327|183157064|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5842|TWO_SIDED|95.0|-1.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||2.6|-1.5|0.5842
91666396|NCT00577655|183226766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.892||||0.924|TWO_SIDED|95.0|-17.634|19.419||significance level of 0.05.|ANOVA|terms for treatment and center|Active - Placebo|Day 1 Baseline||19.419|-17.634|0.9240
91666397|NCT00577655|183226767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.124||||0.2186|TWO_SIDED|95.0|-18.169|78.417||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||78.417|-18.169|0.2186
91666398|NCT00577655|183226767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.578||||0.2375|TWO_SIDED|95.0|-28.541|113.7||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 1 Baseline||113.70|-28.541|0.2375
91666399|NCT00577655|183226768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.524||||0.0017|TWO_SIDED|95.0|2.524|10.523||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 1||10.523|2.524|0.0017
91484001|NCT01907100|182841492|OTHER||Hazard Ratio (HR)|0.782||||0.4132|TWO_SIDED|95.0|0.433|1.412|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II||1.412|0.433|0.4132
91484002|NCT01907100|182841492|OTHER||Hazard Ratio (HR)|1.12||||0.7306|TWO_SIDED|95.0|0.79|1.58||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.58|0.79|0.7306
91484003|NCT01907100|182841493|OTHER||Odds Ratio (OR)|1.09||||0.3189|TWO_SIDED|95.0|0.76|1.58||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||Exact 95% CI by Clopper and Pearson.|1.58|0.76|0.3189
91484004|NCT01907100|182841494|OTHER||Odds Ratio (OR)|0.79||||0.7512|TWO_SIDED|95.0|0.4|1.55||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.|||1.55|0.40|0.7512
91666400|NCT00577655|183226768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.998||||0.0521|TWO_SIDED|95.0|-0.037|8.032||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 22||8.032|-0.037|0.0521
91666401|NCT00577655|183226769|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.477||||0.0647|TWO_SIDED|95.0|0.98|2.23||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||2.23|0.98|0.0647
91632136|NCT03031327|183157064|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4606|TWO_SIDED|95.0|-2.2|1.0|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||1.0|-2.2|0.4606
91632137|NCT03031327|183157064|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.2319|TWO_SIDED|95.0|-3.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||0.8|-3.0|0.2319
91632138|NCT03031327|183157064|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6018|TWO_SIDED|95.0|-2.3|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.4|-2.3|0.6018
91666402|NCT00577655|183226769|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.088||||0.0005|TWO_SIDED|95.0|1.38|3.15||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||3.15|1.38|0.0005
91666403|NCT00577655|183226770|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.141||||0.5059|TWO_SIDED|95.0|0.77|1.69||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||1.69|0.77|0.5059
91632139|NCT03031327|183157064|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4857|TWO_SIDED|95.0|-2.2|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.1|-2.2|0.4857
91632140|NCT03031327|183157064|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9015|TWO_SIDED|95.0|-2.0|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.8|-2.0|0.9015
91632141|NCT03031327|183157065|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
91632142|NCT03031327|183157065|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
91632143|NCT03031327|183157065|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.0|0.0|00
91632144|NCT03031327|183157065|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.0|0.0|00
91632145|NCT03031327|183157065|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
91632146|NCT03031327|183157065|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
91632147|NCT03793010|183157077|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-1.2|1.81||||||||1.81|-1.20|
91632148|NCT03793010|183157078|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.05|2.24||||||||2.24|-1.05|
91632149|NCT03793010|183157079|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|0.9||||||||0.9|-1.0|
91666404|NCT00577655|183226770|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.533||||0.0333|TWO_SIDED|95.0|1.03|2.27||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||2.27|1.03|0.0333
91666405|NCT00577655|183226771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.3888
91666406|NCT00577655|183226771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1249||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.1249
91666407|NCT00577655|183226772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0343||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0343
91666408|NCT00577655|183226772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0962||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0962
91666409|NCT00577655|183226773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0109
91666410|NCT00577655|183226773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0845
91666411|NCT00577655|183226774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0013
91525783|NCT03587142|182927097|SUPERIORITY||Mean Difference (Net)|-0.41||||0.16|TWO_SIDED|95.0|-0.99|0.16||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.16|-0.99|0.16
91666412|NCT00577655|183226774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0085
91666413|NCT00577655|183226775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.072||||0.4674|TWO_SIDED|95.0|-0.265|0.122||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||0.122|-0.265|0.4674
91714325|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.25||0.5776||95.0|-20.9|11.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-20.9|0.5776
91666414|NCT00577655|183226775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171||||0.084|TWO_SIDED|95.0|-0.365|0.023||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 2||0.023|-0.365|0.0840
91666415|NCT00577655|183226775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.138||||0.1699|TWO_SIDED|95.0|-0.335|0.059||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 3||0.059|-0.335|0.1699
91666416|NCT00577655|183226777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.926||||0.1391|TWO_SIDED|95.0|-3.256|23.108||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||23.108|-3.256|0.1391
91666417|NCT00577655|183226777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.923||||0.1043|TWO_SIDED|95.0|-2.278|24.124||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 2||24.124|-2.278|0.1043
91666418|NCT00577655|183226777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.546||||0.157|TWO_SIDED|95.0|-3.705|22.798||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 3||22.798|-3.705|0.1570
91666419|NCT00577655|183226778|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.989||||0.9846|TWO_SIDED|95.0|-0.121|2.099||significance level of 0.05.|mixed poisson regression model|||"Week 1~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.099|-0.121|0.9846
91666420|NCT00577655|183226778|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.961||||0.9447|TWO_SIDED|95.0|-0.116|2.039||significance level of 0.05.|mixed poisson regression model|||"Week 2~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.039|-0.116|0.9447
91666421|NCT00577655|183226778|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.887||||0.8326|TWO_SIDED|95.0|-0.111|1.885||significance level of 0.05.|mixed poisson regression model|||"Week 3~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||1.885|-0.111|0.8326
91666422|NCT01370863|183226779|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-1.452||||0.869|TWO_SIDED|95.0|-19.054|16.149|||ANCOVA|||||16.149|-19.054|0.869
91666423|NCT01370863|183226780|SUPERIORITY_OR_OTHER_LEGACY||Diference in LS means|0.264||||0.487|TWO_SIDED|95.0|-0.495|1.024|||ANCOVA|||||1.024|-0.495|0.487
91666424|NCT01370863|183226781|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.087||||0.637|TWO_SIDED|95.0|-0.501|0.326|||ANCOVA|||||0.326|-0.501|0.637
91666425|NCT05004649|183226791|OTHER|||||||0.024356||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.024356
91666426|NCT05004649|183226791|OTHER|||||||0.040382||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.040382
91632150|NCT00908050|183157080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|||||||Chi-squared|||The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.||||0.0394
91632151|NCT00087594|183157239|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-27.8|41.3||||||95% CI for G1 participants||41.3|-27.8|
91632152|NCT00087594|183157239|SUPERIORITY_OR_OTHER||Difference|13.0|||||TWO_SIDED|95.0|-10.4|35.4||||||95% CI for G2/3 participants||35.4|-10.4|
91632153|NCT00087594|183157239|SUPERIORITY_OR_OTHER||Difference|44.0|||||TWO_SIDED|95.0|12.0|76.9||||||95% CI for G1 participants with 2 log drop at W 12||76.9|12.0|
91632154|NCT00087594|183157239|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|||||||||95% CI for G1 participants with non 2 log drop at W 12||||
91632155|NCT00087594|183157239|SUPERIORITY_OR_OTHER||Difference|-13.0|||||TWO_SIDED|95.0|-77.2|50.5||||||95% CI for G1 participants with missing HCV-RNA at W 12||50.5|-77.2|
91666427|NCT05004649|183226791|OTHER|||||||0.90161||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.90161
91666428|NCT01852799|183226799|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||bALP changes from baseline to cycle 1||||0.002
91666429|NCT01852799|183226799|OTHER||||||<|0.001|||||||t-test, 2 sided|||b-ALP changes from baseline to cycle 4||||<0.001
91632156|NCT01952041|183157260|SUPERIORITY|||||||0.8|||||||Chi-squared|Chi-square test statistic=0.06, degrees of freedom=2||||||0.80
91632157|NCT01952041|183157261|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.43|TWO_SIDED|95.0|0.42|1.44|||Regression, Cox||Hazard ratio is intervention arm vs. TAU for time to first relapse from randomization. There is not a standard error (SE) that directly links to the hazard ratio. The confidence interval provided illustrates the dispersion for the hazard ratio.|||1.44|0.42|0.43
91632158|NCT01952041|183157262|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-0.58|1.02|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||1.02|-0.58|0.58
91666430|NCT01852799|183226799|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||DKK-1 changes from baseline to cycle 1||||0.005
91632159|NCT01952041|183157263|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.84|TWO_SIDED|95.0|-0.22|0.26|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.26|-0.22|0.84
91632160|NCT01952041|183157264|SUPERIORITY||Slope|-2.7|STANDARD_ERROR_OF_MEAN|1.4||0.06|TWO_SIDED|95.0|-5.4|0.04|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.04|-5.40|0.06
91632161|NCT01736176|183157265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.||||< 0.001
91632162|NCT01736176|183157269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||||||0.004
91632163|NCT01569568|183157303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PCGM.||||0.001
91632164|NCT01569568|183157303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PCGM.||||0.011
91632165|NCT01569568|183157303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PWM.||||0.004
91632166|NCT01569568|183157303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PWM.||||0.046
91632167|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the DMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all DMN nodes is the same across groups.||||<0.001
91632168|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the left IPL node does not differ between groups.||||0.024
91666431|NCT01852799|183226799|OTHER||||||<|0.001|||||||t-test, 2 sided|||DKK-1 changes from baseline to cycle 4||||<0.001
91666432|NCT02654145|183226832|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.13|-0.66||p-value is for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|||-0.66|-1.13|<0.001
91666433|NCT02654145|183226832|SUPERIORITY||Mean Difference (Final Values)|-1.34|||<|0.001|TWO_SIDED|95.0|-1.68|-1.0||p- value for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used Xolair.|||-1.00|-1.68|<0.001
91484005|NCT00667602|182841517|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage Difference|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .||-1|-15|
91632169|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the PCC node does not differ between groups.||||0.040
91632170|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the right IPL node does not differ between groups.||||0.008
91632171|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left IPL node and the right IPL node does not differ between groups.||||0.470
91632172|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the left IPL node does not differ between groups.||||0.829
91484006|NCT00667602|182841518|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.||-2|-13|
91632173|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.801|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the right IPL node does not differ between groups.||||0.801
91632174|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the SMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all SMN nodes is the same across groups.||||<0.001
91632175|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left aI/fO node does not differ between groups.||||0.550
91632176|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left SFG node does not differ between groups.||||0.113
91632177|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right aI/fO node does not differ between groups.||||0.039
91484007|NCT00667602|182841519|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|72.0|||||TWO_SIDED|95.0|64.0|79.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||79|64|
91632178|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right SFG node does not differ between groups.||||0.005
91632179|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the left SFG node does not differ between groups.||||0.426
91632180|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO node and the right aI/fO node does not differ between groups.||||0.256
91632181|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the right SFG node does not differ between groups.||||0.853
91632182|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the left SFG node does not differ between groups.||||0.003
91632183|NCT01569568|183157304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the right SFG node does not differ between groups.||||0.023
91484008|NCT00667602|182841519|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Net)|7.0|||||TWO_SIDED|95.0|3.0|13.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||13|3|
91632184|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929|TWO_SIDED|||||Equal variance is not assumed. Two tailed t-test WASI verbal IQ between cases and controls|t-test, 2 sided|||||||.929
91484009|NCT00667602|182841519|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|80.0|||||TWO_SIDED|95.0|73.0|86.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||86|73|
91484010|NCT00667602|182841519|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.0|5.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||5|-2|
91484011|NCT00667602|182841521|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.12|0.76|
91525784|NCT03587142|182927098|SUPERIORITY||Mean Difference (Net)|-0.65||||0.03|TWO_SIDED|95.0|-1.23|-0.08||P values are nominal; no adjustments made for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||-0.08|-1.23|0.03
91632185|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||Equal variance not assumed. Comparison WASI performance IQ cases and controls|t-test, 2 sided|||||||.002
91632186|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094|TWO_SIDED|||||Equal variance not assumed. Comparison of WASI full IQ cases and controls|t-test, 2 sided|||||||.094
91666434|NCT02654145|183226834|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.47|||Generalised Estimating Equations||Analysis performed using generalized estimating equation (GEE) model assuming a negative binomial distribution with a covariate of treatment period (pre-treatment , on- and off-treatment), logarithm of time as an offset variable|||0.47|0.28|<0.001
91484012|NCT00667602|182841521|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.73|||||TWO_SIDED|95.0|0.57|0.93|||ANOVA|||For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||0.93|0.57|
91484013|NCT00667602|182841523|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|10.0|||||TWO_SIDED|95.0|8.43|13.0|||ANOVA|||For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .||13|8.43|
91527820|NCT06173570|182930685|SUPERIORITY||Mean Difference (Net)|-3.53||||0.111|TWO_SIDED|95.0|-7.87|0.81|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||0.81|-7.87|0.111
91632187|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||Equal variance not assumed. Comparison of CTMT global composite score between cases and controls|t-test, 2 sided|||||||.853
91632188|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Equal variance not assumed. Comparison of BRIEF BRI cases and controls|t-test, 2 sided|||||||.001
91632189|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF MI cases and controls|t-test, 2 sided|||||||<.001
91632190|NCT01569568|183157306|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF GEC between cases and controls.|t-test, 2 sided|||||||<0.001
91632191|NCT00416572|183157315|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||> 0.05
91632192|NCT00416572|183157315|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
91484014|NCT00667602|182841523|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|8.1|||||TWO_SIDED|95.0|6.35|10.0|||ANOVA|||For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.||10|6.35|
91484015|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
91484016|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
91484017|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||5|-3|
91484018|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-3|
91484019|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
91484020|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
91484021|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-2.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
91525785|NCT03587142|182927099|SUPERIORITY||Mean Difference (Net)|0.17||||0.59|TWO_SIDED|95.0|-0.44|0.77||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.77|-0.44|0.59
91632193|NCT00416572|183157315|SUPERIORITY_OR_OTHER||standardized beta|-0.12|||=|0.08|TWO_SIDED||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.08
91484022|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
91632194|NCT00416572|183157315|SUPERIORITY_OR_OTHER||standardized beta|-0.23|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
91632195|NCT00416572|183157316|SUPERIORITY_OR_OTHER||||||>|0.5|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.50
91484023|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
91484024|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
91484025|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
91484026|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-3|
91484027|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
91484028|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
91484029|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
91525786|NCT03587142|182927100|SUPERIORITY||Mean Difference (Net)|0.24||||0.46|TWO_SIDED|95.0|-0.39|0.88||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.88|-0.39|0.46
91714326|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.06||0.5665||95.0|-20.5|11.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.3|-20.5|0.5665
91527821|NCT06173570|182930685|SUPERIORITY||Mean Difference (Net)|0.38||||0.864|TWO_SIDED|95.0|-3.98|4.74|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||4.74|-3.98|0.864
91484030|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
91484031|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
91484032|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-4|
91484033|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
91484034|NCT00667602|182841524|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
91484035|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-13.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-13|
91484036|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-12.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-12|
91484037|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.||2|-11|
91632196|NCT00416572|183157316|SUPERIORITY_OR_OTHER||Standardized beta|0.14|||=|0.04|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.04
91632197|NCT00416572|183157316|SUPERIORITY_OR_OTHER||Standardized beta|0.25|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
91484038|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
91632198|NCT00416572|183157316|SUPERIORITY_OR_OTHER||Standardized beta|0.15|||=|0.02|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.02
91632199|NCT00416572|183157317|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome||||>.05
91714327|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.5|STANDARD_ERROR_OF_MEAN|8.13||0.0041||95.0|-39.6|-7.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.5|-39.6|0.0041
91484039|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-19.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-19|
91484040|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-17.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-17|
91632200|NCT00416572|183157317|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
91666435|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2613|||||ONE_SIDED|95.0||0.31||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.31||
91666436|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.027|||||ONE_SIDED|95.0||0.0449||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0449||
91666437|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.1351|||||ONE_SIDED|95.0||0.1729||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1729||
91666438|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.1216|||||ONE_SIDED|95.0||0.1577||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.1577||
91666439|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0405|||||ONE_SIDED|95.0||0.0623||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0623||
91666440|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2798|||||ONE_SIDED|95.0||0.3329||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.3329||
91666441|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.0052|||||ONE_SIDED|95.0||0.0137||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0137||
91527822|NCT06173570|182930685|SUPERIORITY||Mean Difference (Net)|-1.68||||0.445|TWO_SIDED|95.0|-5.99|2.63|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||2.63|-5.99|0.445
91632201|NCT00416572|183157317|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
91632202|NCT00416572|183157317|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
91632203|NCT00290355|183157318|OTHER||Hazard Ratio (HR)|0.74||||0.256|TWO_SIDED|95.0|0.44|1.24||Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = \[HR=1\]).|Regression, Cox|The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value \< 10%||Hazard ratio of GSK 249553 study product.||1.24|0.44|0.256
91632204|NCT03345849|183157337|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and European Union/European Medicines Agency regulatory purposes.|Adjusted Response Rate Difference|20.8|||<|0.0001|TWO_SIDED|95.0|12.7|28.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|Comparison of the upadacitinib group and placebo group was performed using the Cochran Mantel-Haenszel (CMH) test adjusting for stratification factors (baseline steroid use \[Yes, No\], endoscopic disease severity \[SES-CD \< 15, ≥ 15\] and number of prior biologics with prior inadequate response or intolerance \[0, 1, \> 1\]).||28.8|12.7|<0.0001
91632205|NCT03345849|183157338|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|28.7|||<|0.0001|TWO_SIDED|95.0|20.9|36.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||36.4|20.9|<0.0001
91666442|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.0881|||||ONE_SIDED|95.0||0.1216||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1216||
91666443|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.3264|||||ONE_SIDED|95.0||0.3819||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.3819||
91666444|NCT00354835|183226843|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0104|||||ONE_SIDED|95.0||0.0224||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0224||
91666445|NCT00354835|183226846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.||||0.99
91666446|NCT00354835|183226846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.||||0.036
91666447|NCT01968551|183226851|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA\<50 copies/mL at Week 24.|Difference in proportion|5.3||||0.23|TWO_SIDED|95.001|-3.4|17.4|||Fisher Exact||Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.|||17.4|-3.4|0.23
91666448|NCT01968551|183226852|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 48.|Difference in proportion|18.3||||0.004|TWO_SIDED|95.001|3.5|33.0|||Fisher Exact||Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|||33.0|3.5|0.004
91666449|NCT06475729|183226855|EQUIVALENCE|Log-transformed PK parameters were analyzed using a fixed-effects model. Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of Geometric least squares mean|1.039|||||TWO_SIDED|90.0|0.9853|1.0956||||||||1.0956|0.9853|
91666450|NCT06475729|183226856|EQUIVALENCE|Log-transformed PK parameters were analyzed using a fixed-effects model. Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of Geometric least squares mean|1.011|||||TWO_SIDED|90.0|0.9564|1.0685||||||||1.0685|0.9564|
91484041|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||1|-12|
91484042|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-12|
91484043|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-11|
91484044|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-10|
91484045|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
91484046|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-15.0|||||TWO_SIDED|95.0|-24.0|-6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-6|-24|
91525787|NCT03587142|182927101|SUPERIORITY||Mean Difference (Net)|0.09||||0.73|TWO_SIDED|95.0|-0.42|0.59||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.59|-0.42|0.73
91527823|NCT06173570|182930685|SUPERIORITY||Mean Difference (Net)|1.01||||0.648|TWO_SIDED|95.0|-3.32|5.34|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||5.34|-3.32|0.648
91632206|NCT03345849|183157339|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|33.0|||<|0.0001|TWO_SIDED|95.0|26.2|39.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||39.9|26.2|<0.0001
91632207|NCT03345849|183157340|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.8|27.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||27.8|15.8|<0.0001
91666451|NCT06475729|183226857|EQUIVALENCE|Log-transformed PK parameters were analyzed using a fixed-effects model. Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of Geometric least squares mean|1.011|||||TWO_SIDED|90.0|0.9568|1.0678||||||||1.0678|0.9568|
91666452|NCT03922750|183226861|OTHER||Estimated mean treatment difference|1.01||||0.7542|TWO_SIDED|95.0|-5.33|7.35|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||7.35|-5.33|0.7542
91666453|NCT03922750|183226861|OTHER||Estimated mean treatment difference|7.88||||0.0107|TWO_SIDED|95.0|1.83|13.93|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||13.93|1.83|0.0107
91666454|NCT01046084|183226888|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|86.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|86.5|
91666455|NCT01046084|183226889|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.0|||||TWO_SIDED|90.0|89.3|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120|89.3|
91666456|NCT01046084|183226890|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.0|||||TWO_SIDED|90.0|92.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|92.5|
91666457|NCT03868631|183226914|SUPERIORITY||||||<|0.05|||||||multilevel models for change|||Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p\<0.05.||||<0.05
91484047|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-9.0|||||TWO_SIDED|95.0|-17.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-17|
91484048|NCT00667602|182841525|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-13|
91666458|NCT03867760|183226918|SUPERIORITY|The study was designed to detect a difference in pain intensity of at least 0.85 points corresponding to an effect size of 0.57 based on results from our pilot study. The sample size needed was 50 per group based on power of .80, alpha of .05.||||||0.809||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain intensity than cancer survivors assigned to the relaxation intervention.||||0.809
91666459|NCT03867760|183226919|SUPERIORITY|||||||0.369||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain interference than cancer survivors assigned to the relaxation intervention.||||0.369
91484049|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|71.0|||||TWO_SIDED|95.0|63.0|78.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||78|63|
91484050|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||6|-3|
91527824|NCT06173570|182930686|SUPERIORITY||Mean Difference (Net)|-6.5||||0.266|TWO_SIDED|95.0|-17.97|4.96|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||4.96|-17.97|0.266
91484051|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||7|-2|
91484052|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
91527491|NCT02597933|182930149|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.5914|TWO_SIDED|95.0|-0.16|0.09|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.09|-0.16|0.5914
91632208|NCT03345849|183157341|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|27.7|||<|0.0001|TWO_SIDED|95.0|15.7|39.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors endoscopic disease severity and number of prior failed biologic therapies.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors endoscopic disease severity and number of prior biologic failed.|||39.8|15.7|<0.0001
91632209|NCT03345849|183157342|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Least Squares (LS) Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|4.2|8.3|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||8.3|4.2|<0.0001
91632210|NCT03345849|183157343|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|LS Mean Difference|21.842|STANDARD_ERROR_OF_MEAN|3.1933|<|0.0001|TWO_SIDED|95.0|15.566|28.118|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||28.118|15.566|<0.0001
91632211|NCT03345849|183157344|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|11.7||||0.0022|TWO_SIDED|95.0|4.2|19.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.2|4.2|0.0022
91666460|NCT03867760|183226920|SUPERIORITY|||||||0.029||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in anxiety than cancer survivors assigned to the relaxation intervention.||||0.029
91666461|NCT03867760|183226921|SUPERIORITY|||||||0.236||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in depression than cancer survivors assigned to the relaxation intervention.||||0.236
91666462|NCT03867760|183226922|SUPERIORITY|||||||0.904||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in fatigue than cancer survivors assigned to the relaxation intervention.||||0.904
91666463|NCT03867760|183226923|SUPERIORITY|||||||0.936||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in sleep disturbance than cancer survivors assigned to the relaxation intervention.||||0.936
91666464|NCT03867760|183226924|SUPERIORITY|||||||0.02||||||An a priori significance level was set at 0.05.|t-test, 2 sided|||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention who experience a clinically meaningful improvement in pain intensity will not have a significantly higher pre-treatment treatment credibility and expectancy score than non-improvers.||||0.02
91484053|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|31.0|||||TWO_SIDED|95.0|24.0|39.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||39|24|
91484054|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||4|-2|
91484055|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||11|-3|
91484056|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-13.0|||||TWO_SIDED|95.0|-22.0|-5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-5|-22|
91484057|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-10.0|||||TWO_SIDED|95.0|-17.0|-4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-4|-17|
91484058|NCT00667602|182841530|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
91484059|NCT00667602|182841532|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Ratio|1.33|||||TWO_SIDED|95.0|0.96|1.83|||ANOVA|||For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.83|0.96|
91484060|NCT01436162|182841540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.92||0.583|TWO_SIDED|95.0|-2.3|1.3|||Mixed-effects Model for Repeat Measures|||||1.3|-2.3|0.583
91484061|NCT01436162|182841541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.354|TWO_SIDED|95.0|-1.9|0.7|||Mixed-effects Model for Repeat Measures|||||0.7|-1.9|0.354
91666465|NCT03395197|183226956|SUPERIORITY||Hazard Ratio (HR)|0.627|||<|0.0001|TWO_SIDED|95.0|0.506|0.777||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.||0.777|0.506|<0.0001
91484062|NCT02567552|182841554|OTHER|||||||0.3395|||||||Chi-squared|||||||0.3395
91484063|NCT02567552|182841555|OTHER|||||||0.1523|||||||Chi-squared|||||||0.1523
91484064|NCT02567552|182841556|OTHER|||||||0.1189|||||||t-test, 2 sided|||comparison between groups||||0.1189
91484065|NCT02567552|182841558|OTHER|||||||0.2042|||||||t-test, 2 sided|||||||0.2042
91484066|NCT02567552|182841559|OTHER|||||||0.6262|||||||t-test, 2 sided|||||||0.6262
91484067|NCT02567552|182841560|OTHER|||||||0.2301|||||||t-test, 2 sided|||||||0.2301
91484068|NCT02567552|182841561|OTHER|||||||0.5118|||||||t-test, 2 sided|||||||0.5118
91484069|NCT02567552|182841562|OTHER|||||||0.8371|||||||t-test, 2 sided|||||||0.8371
91484070|NCT02567552|182841563|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91484071|NCT02567552|182841564|OTHER|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
91484072|NCT02567552|182841565|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
91484073|NCT05032859|182841568|SUPERIORITY||Risk Ratio, log|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|3.32|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||3.32|1.54|<0.0001
91666466|NCT03395197|183226957|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.328|0.61||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.||0.610|0.328|<0.0001
91666467|NCT03123874|183226975|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.827||||0.9|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial taxa in milk collected with own / sterile pump set-ups.|||||0.9
91666468|NCT03123874|183226976|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.163||||0.3|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean Shannon Diversity Index in milk collected with own / sterile pump set-ups|||||0.3
91666469|NCT03123874|183226977|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first). Random effect was participant ID to account for multiple samples for each participant.|Mean Difference (Final Values)|4.95||||0.0003|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial counts in milk collected with own / sterile pump set-ups.|||||0.0003
91666470|NCT02578641|183226985|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.1942|TWO_SIDED|95.0|0.91|1.56||Between-treatment comparisons were assessed using stratified log-rank test stratified by country and disease stage per randomization stratification.|Log Rank|Log-rank test of Hazards Ration equals 1, using Cox proportional hazards regression.|Hazard ratios were estimated using Cox proportional hazards regression.|||1.56|0.91|0.1942
91666471|NCT02655224|183226999|SUPERIORITY|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|42.071|||<|0.0001|TWO_SIDED|95.0|5.113|346.181|||Fisher's Exact Test||Relugolix 40 mg/Placebo|||346.181|5.113|<0.0001
91666472|NCT02655224|183227000|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|29.176|||||TWO_SIDED|95.0|3.555|239.478|||||Relugolix 40 mg/Placebo|||239.478|3.555|
91666473|NCT02655224|183227001|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-1.05|0.069|||||Relugolix 40 mg-Placebo|||0.069|-1.050|
91484074|NCT05032859|182841569|SUPERIORITY||Risk Ratio, log|2.14|||<|0.0001|TWO_SIDED|95.0|1.53|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.53|<0.0001
91484075|NCT05032859|182841570|SUPERIORITY||Least squares mean difference|-6.6|STANDARD_ERROR_OF_MEAN|0.803|<|0.0001|TWO_SIDED|95.0|-8.17|-5.02|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-5.02|-8.17|<0.0001
91484076|NCT05032859|182841571|SUPERIORITY||Risk Ratio, log|2.34||||0.0013|TWO_SIDED|95.0|1.39|3.94|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.||Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|3.94|1.39|0.0013
91527492|NCT02597933|182930150|OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.034||0.3447|TWO_SIDED|95.0|-0.035|0.099|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.099|-0.035|0.3447
91666474|NCT02655224|183227002|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|11.96|||||TWO_SIDED|95.0|-3.201|27.112|||||Relugolix 40 mg-Placebo|||27.112|-3.201|
91666475|NCT02655224|183227003|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.625|||||TWO_SIDED|95.0|1.605|19.709|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||19.709|1.605|
91666476|NCT02655224|183227003|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|9.865|||||TWO_SIDED|95.0|2.784|34.955|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||34.955|2.784|
91666477|NCT02655224|183227004|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.438|||||TWO_SIDED|95.0|1.071|27.609|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||27.609|1.071|
91632212|NCT03345849|183157345|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.3|28.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.4|11.3|<0.0001
91484077|NCT05032859|182841572|SUPERIORITY||Risk Ratio, log|2.17||||0.0015|TWO_SIDED|95.0|1.34|3.5|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.50|1.34|0.0015
91632213|NCT03345849|183157346|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|10.8||||0.0071|TWO_SIDED|95.0|2.9|18.6|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||18.6|2.9|0.0071
91632214|NCT03345849|183157347|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Response Rate Difference|-1.4||||0.4494|TWO_SIDED|95.0|-5.2|2.4|||Chi-squared||Response rate difference = Upadacitinib - Placebo|||2.4|-5.2|0.4494
91632215|NCT03345849|183157348|OTHER|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|9.0||||0.1044|TWO_SIDED|95.0|-1.9|19.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.9|-1.9|0.1044
91632216|NCT03345849|183157349|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.2|||<|0.0001|TWO_SIDED|95.0|14.3|28.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.2|14.3|<0.0001
91632217|NCT03345849|183157350|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|32.6|||<|0.0001|TWO_SIDED|95.0|21.5|43.7|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||43.7|21.5|<0.0001
91632218|NCT00723489|183157358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.86|TWO_SIDED|95.0|-0.3|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.3|0.86
91632219|NCT00723489|183157359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.86|TWO_SIDED|95.0|-0.2|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.2|0.86
91632220|NCT00723489|183157360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1|TWO_SIDED|95.0|-0.5|0.05||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.05|-0.5|0.10
91632221|NCT00723489|183157361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.66|TWO_SIDED|95.0|-0.2|0.3||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.3|-0.2|0.66
91632222|NCT00723489|183157362|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.24
91632223|NCT00723489|183157363|SUPERIORITY_OR_OTHER|||||||0.43||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.43
91632224|NCT00723489|183157364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.1||||0.48|TWO_SIDED|95.0|-0.1|0.3||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.3|-0.1|0.48
91714328|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|8.22||0.1842||95.0|-27.1|5.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-27.1|0.1842
91484078|NCT01876810|182841591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1|TWO_SIDED|95.0||||For all analyses, results are considered significant at p\<.05.|t-test, 2 sided|||||||0.1
91632225|NCT00723489|183157365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.3||||0.036|TWO_SIDED|95.0|-0.5|-0.02||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.02|-0.5|0.036
91632226|NCT00723489|183157366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.04||||0.82|TWO_SIDED|95.0|-0.3|0.4||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.4|-0.3|0.82
91632227|NCT00723489|183157367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.4||||0.045|TWO_SIDED|95.0|-0.7|-0.01||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.01|-0.7|0.045
91632228|NCT04437511|183157374|SUPERIORITY||LS Mean change difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|1.508|4.331|||Mixed Models Analysis|||||4.331|1.508|<0.001
91632229|NCT04437511|183157375|SUPERIORITY||LS Mean change difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.883|4.618|||Mixed Models Analysis|||||4.618|1.883|<0.001
91632230|NCT04437511|183157376|SUPERIORITY||LS Mean change difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|0.104|0.841|||Mixed Models Analysis|||||0.841|0.104|0.012
91632231|NCT04437511|183157377|SUPERIORITY||LS Mean change difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.016|TWO_SIDED|95.0|0.089|0.868|||Mixed Models Analysis|||||0.868|0.089|0.016
91632232|NCT04437511|183157378|SUPERIORITY||LS Mean change difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.39||0.0006|TWO_SIDED|95.0|-2.086|-0.565|||Mixed Models Analysis|||||-0.565|-2.086|0.0006
91632233|NCT04437511|183157379|SUPERIORITY||LS Mean change difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.25|-0.794|||Mixed Models Analysis|||||-0.794|-2.250|<0.001
91632234|NCT04437511|183157380|SUPERIORITY||LS Mean change difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.95|-0.45|||Mixed Models Analysis|||||-0.45|-0.95|<0.001
91632235|NCT04437511|183157381|SUPERIORITY||LS Mean change difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.95|-0.4|||Mixed Models Analysis|||||-0.40|-0.95|<0.001
91666478|NCT02655224|183227004|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|12.794|||||TWO_SIDED|95.0|2.603|62.88|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||62.880|2.603|
91666479|NCT02655224|183227005|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|0.09|||||TWO_SIDED|95.0|-0.574|0.745|||||Relugolix 40 mg-Placebo|Day 1 to 28||0.745|-0.574|
91632236|NCT04437511|183157382|SUPERIORITY||LS Mean change difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.44||0.0001|TWO_SIDED|95.0|0.84|2.566|||Mixed Models Analysis|||||2.566|0.840|0.0001
91632237|NCT04437511|183157383|SUPERIORITY||LS Mean change difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|0.913|2.748|||Mixed Models Analysis|||||2.748|0.913|<0.001
91632238|NCT04437511|183157384|SUPERIORITY||LS Mean change difference (Final Values)|-86.37|STANDARD_ERROR_OF_MEAN|1.275|<|0.0001|TWO_SIDED|95.0|-88.87|-83.87|||Mixed Models Analysis|||||-83.87|-88.87|<0.0001
91632239|NCT04437511|183157385|SUPERIORITY||LS Mean change difference (Final Values)|-0.0041||||0.4522|TWO_SIDED|95.0|-0.0148|0.0066|||ANCOVA|||||0.0066|-0.0148|0.4522
91632240|NCT04437511|183157386|SUPERIORITY||LS Mean change difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.002|TWO_SIDED|95.0|0.01|0.04|||Mixed Models Analysis|||Bilateral Hippocampus||0.04|0.01|0.002
91632241|NCT04437511|183157386|SUPERIORITY||LS Mean change difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|0.561|<|0.001|TWO_SIDED|95.0|-7.76|-5.56|||Mixed Models Analysis|||Bilateral Whole Brain||-5.56|-7.76|<0.001
91632242|NCT04437511|183157386|SUPERIORITY||LS Mean change difference (Final Values)|3.02|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|2.52|3.52|||Mixed Models Analysis|||Bilateral Ventricles||3.52|2.52|<0.001
91632243|NCT05032755|183157389|SUPERIORITY||beta estimate|1.902|STANDARD_ERROR_OF_MEAN|0.398|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term|||||<.0001
91632244|NCT05032755|183157390|SUPERIORITY||beta estimate|0.368|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||<.0001
91632245|NCT05032755|183157391|SUPERIORITY||beta estimate|0.672|STANDARD_ERROR_OF_MEAN|0.362||0.065|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.065
91632246|NCT05032755|183157392|SUPERIORITY||beta estimate|0.364|STANDARD_ERROR_OF_MEAN|0.133||0.007|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.007
91666480|NCT02655224|183227005|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.57|||||TWO_SIDED|95.0|-1.19|0.049|||||Relugolix 40 mg-Placebo|Day 29 to 56||0.049|-1.190|
91484079|NCT01876810|182841591|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.1
91632247|NCT05032755|183157393|SUPERIORITY||beta estimate|1.78|STANDARD_ERROR_OF_MEAN|1.78||0.325|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.325
91632248|NCT05032755|183157395|SUPERIORITY||beta estimate|0.222|STANDARD_ERROR_OF_MEAN|0.104||0.035|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.035
91632249|NCT05032755|183157396|SUPERIORITY||beta estimate|0.201|STANDARD_ERROR_OF_MEAN|0.181||0.27|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.27
91632250|NCT05032755|183157397|SUPERIORITY||beta estimate|-1.229|STANDARD_ERROR_OF_MEAN|1.037||0.24|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.24
91632251|NCT05032755|183157402|SUPERIORITY||beta estimate|4.69|STANDARD_ERROR_OF_MEAN|2.88||0.113|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.113
91632252|NCT05564039|183157435|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.69|||Mixed Models Analysis|||||-0.69|-1.10|<0.0001
91632253|NCT05564039|183157436|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.7|-6.0|||Mixed Models Analysis|||||-6.0|-8.7|<.0001
91632254|NCT05564039|183157437|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|3.82|13.32|||Regression, Logistic|||||13.32|3.82|<0.0001
91632255|NCT05564039|183157438|SUPERIORITY||Odds Ratio (OR)|12.24|||<|0.0001|TWO_SIDED|95.0|6.51|23.02|||Regression, Logistic|||||23.02|6.51|<0.0001
91632256|NCT05564039|183157439|SUPERIORITY||Odds Ratio (OR)|15.34|||<|0.0001|TWO_SIDED|95.0|4.58|51.36|||Regression, Logistic|||||51.36|4.58|<0.0001
91632257|NCT05564039|183157440|SUPERIORITY||Odds Ratio (OR)|9.31|||<|0.0001|TWO_SIDED|95.0|5.11|16.98|||Regression, Logistic|||||16.98|5.11|<0.0001
91632258|NCT05564039|183157441|SUPERIORITY||Odds Ratio (OR)|19.35|||<|0.0001|TWO_SIDED|95.0|9.07|41.3|||Regression, Logistic|||||41.30|9.07|<0.0001
91666481|NCT02655224|183227005|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.54|||||TWO_SIDED|95.0|-1.074|-0.012|||||Relugolix 40 mg-Placebo|Day 57 to 84||-0.012|-1.074|
91666482|NCT02655224|183227006|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|4.17|||||TWO_SIDED|95.0|-11.507|19.839|||||Relugolix 40 mg-Placebo|Day 1 to 28||19.839|-11.507|
91484080|NCT01876810|182841592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.034||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
91632259|NCT05564039|183157442|SUPERIORITY||Odds Ratio (OR)|35.83|||<|0.0001|TWO_SIDED|95.0|7.18|178.89|||Regression, Logistic|||||178.89|7.18|<0.0001
91632260|NCT05564039|183157443|SUPERIORITY||Odds Ratio (OR)|20.44|||<|0.0001|TWO_SIDED|95.0|8.4|49.77|||Regression, Logistic|||||49.77|8.40|<0.0001
91632261|NCT05564039|183157444|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.32|-0.49|||ANCOVA|||||-0.49|-1.32|<0.001
91632262|NCT05564039|183157445|SUPERIORITY||LS Mean difference (Final Values)|-5.1||||0.0002|TWO_SIDED|95.0|-7.8|-2.5|||Mixed Models Analysis|||||-2.5|-7.8|0.0002
91632263|NCT05564039|183157446|SUPERIORITY||LS Mean difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1|||Mixed Models Analysis|||||-2.1|-3.1|<0.0001
91632264|NCT05564039|183157447|SUPERIORITY||LS Mean difference (Final Values)|4.1||||0.1181|TWO_SIDED|95.0|-1.0|9.2|||ANCOVA|||||9.2|-1.0|0.1181
91632265|NCT03233308|183157449|OTHER|||||||0.001|||||||t-test, 1 sided|||Mean Change from Baseline||||0.0010
91632266|NCT03233308|183157450|OTHER|||||||0.0003|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)||||0.0003
91632267|NCT03233308|183157451|OTHER|||||||0.0687|||||||t-test, 1 sided|||Mean change from baseline -EVP||||0.0687
91632268|NCT03233308|183157451|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline -IOP||||<0.0001
91632269|NCT03233308|183157452|OTHER|||||||0.0087|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline) -EVP||||0.0087
91632270|NCT03233308|183157452|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)- IOP||||<0.0001
91632271|NCT04916314|183157484|SUPERIORITY||Mean Difference (Net)|-0.7||||0.8|TWO_SIDED|95.0|-5.0|3.6||Omnibus likelihood ratio test for significant change in co-primary outcomes at 3 or 12 months|Mixed Models Analysis|||||3.6|-5|0.8
91632272|NCT04916314|183157485|SUPERIORITY||Mean Difference (Net)|-1.5||||0.8|TWO_SIDED|95.0|-5.7|2.8||omnibus likelihood ratio test for significant change in co-primary outcomes at 3 or 12 months|Mixed Models Analysis|||||2.8|-5.7|0.8
91666483|NCT02655224|183227006|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|12.7|||||TWO_SIDED|95.0|-3.098|28.494|||||Relugolix 40 mg-Placebo|Day 29 to 56||28.494|-3.098|
91666484|NCT02655224|183227006|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|11.6|||||TWO_SIDED|95.0|-3.554|26.745|||||Relugolix 40 mg-Placebo|Day 57 to 84||26.745|-3.554|
91792439|NCT02047318|183462631|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|7.4|STANDARD_DEVIATION|210.32||0.8863|TWO_SIDED|95.0|-100.7|115.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||115.6|-100.7|0.8863
91484081|NCT01876810|182841592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
91484082|NCT01876810|182841593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.3|STANDARD_ERROR_OF_MEAN|31.7||0.4|TWO_SIDED|95.0|||||ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|participants self-reportd VAS craving at the time of neutral cue presentation|||||0.4
91484083|NCT01876810|182841593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.7|STANDARD_ERROR_OF_MEAN|26.5||0.4|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used||||||0.4
91484084|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.48|0.94|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 4||0.94|0.48|
91484085|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 6B||1.04|0.64|
91484086|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 9V||1.23|0.74|
91632273|NCT00853112|183157522|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-115.0|STANDARD_DEVIATION|98.36||0.12|TWO_SIDED|95.0|-371.5|-1.1|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and standard deviation (SD) from the Bayesian analysis.||-1.1|-371.5|0.120
91484087|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.45|1.01|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 14||1.01|0.45|
91484088|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.96|||||TWO_SIDED|95.0|0.7|1.31|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 18C||1.31|0.70|
91484089|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.56|||||TWO_SIDED|95.0|0.4|0.77|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 19F||0.77|0.40|
91484090|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 23F||1.05|0.64|
91484091|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.97|||||TWO_SIDED|95.0|1.39|2.8|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 4||2.80|1.39|
91484092|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|3.04|||||TWO_SIDED|95.0|2.41|3.84|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 6B||3.84|2.41|
91484093|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.26|||||TWO_SIDED|95.0|0.98|1.62|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 9V||1.62|0.98|
91484094|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|6.66|||||TWO_SIDED|95.0|4.53|9.79|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 14||9.79|4.53|
91484095|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.34|||||TWO_SIDED|95.0|1.68|3.24|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 18C||3.24|1.68|
91632274|NCT00853112|183157522|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-170.6|STANDARD_DEVIATION|107.84||0.25|TWO_SIDED|95.0|-409.2|-7.1|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-7.1|-409.2|0.250
91666485|NCT04227899|183227026|OTHER||||||<|0.0001|||||||One-sided Chi-square test|||||||<0.0001
91484096|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|4.47|||||TWO_SIDED|95.0|3.29|6.07|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 19F||6.07|3.29|
91484097|NCT01298544|182841596|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.08|||||TWO_SIDED|95.0|1.65|2.63|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 23F||2.63|1.65|
91484098|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|-18.5|||||TWO_SIDED|95.0|-29.4|-7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 4||-7.3|-29.4|
91484099|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.1|3.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 6B||3.0|-3.1|
91484100|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-5.9|7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 9V||7.3|-5.9|
91484101|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-10.3|3.1|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 14||3.1|-10.3|
91525788|NCT03587142|182927102|SUPERIORITY||Mean Difference (Net)|-0.14||||0.5|TWO_SIDED|95.0|-0.55|0.27||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.27|-0.55|0.50
91632275|NCT00853112|183157522|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-240.2|STANDARD_DEVIATION|109.28||0.485|TWO_SIDED|95.0|-444.8|-33.8|||Bayesian 4-parameter Emax model.|||The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-33.8|-444.8|0.485
91632276|NCT00853112|183157522|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-327.9|STANDARD_DEVIATION|92.41||0.81|TWO_SIDED|95.0|-492.9|-148.0|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-148.0|-492.9|0.810
91632277|NCT00853112|183157522|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-379.4|STANDARD_DEVIATION|73.61||0.974|TWO_SIDED|95.0|-520.6|-238.8|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-238.8|-520.6|0.974
91632278|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-195.3|STANDARD_ERROR_OF_MEAN|207.38||0.354|TWO_SIDED|95.0|-618.8|228.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using Analysis of Covariance (ANCOVA) with baseline fitted as a covariate.||228.3|-618.8|0.354
91632279|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.1|STANDARD_ERROR_OF_MEAN|190.99||0.86|TWO_SIDED|95.0|-424.1|356.0|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||356.0|-424.1|0.860
91632280|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-435.7|STANDARD_ERROR_OF_MEAN|195.94||0.034|TWO_SIDED|95.0|-835.9|-35.6|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||-35.6|-835.9|0.034
91484102|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.7|-1.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 18C||-1.0|-22.7|
91632281|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-334.7|STANDARD_ERROR_OF_MEAN|201.74||0.107|TWO_SIDED|95.0|-746.7|77.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||77.3|-746.7|0.107
91632282|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-278.0|STANDARD_ERROR_OF_MEAN|200.89||0.177|TWO_SIDED|95.0|-688.3|132.2|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||132.2|-688.3|0.177
91484103|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-7.1|0.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 19F||0.6|-7.1|
91632283|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.1|STANDARD_ERROR_OF_MEAN|315.91||0.873|TWO_SIDED|95.0|-594.1|696.3|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||696.3|-594.1|0.873
91632284|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|75.2|STANDARD_ERROR_OF_MEAN|303.08||0.806|TWO_SIDED|95.0|-543.8|694.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||694.1|-543.8|0.806
91666486|NCT04227899|183227027|OTHER|||||||0.0019|||||||Farrington-Manning non-inferiority (NI)|||||||0.0019
91666487|NCT04227899|183227028|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91666488|NCT04227899|183227029|OTHER|||||||0.0081|||||||One-sided Chi-square test|||||||0.0081
91666489|NCT05151471|183227030|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
91484104|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.5|2.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 23F||2.3|-4.5|
91484105|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|25.0|||||TWO_SIDED|95.0|12.7|37.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 4||37.0|12.7|
91484106|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-0.011|7.715|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 6B||7.715|-0.011|
91484107|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|10.3|||||TWO_SIDED|95.0|1.9|19.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 9V||19.6|1.9|
91484108|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|29.7|||||TWO_SIDED|95.0|19.4|40.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 14||40.5|19.4|
91484109|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|30.0|||||TWO_SIDED|95.0|17.9|41.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 18C||41.5|17.9|
91484110|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|6.5|||||TWO_SIDED|95.0|1.2|13.9|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 19F||13.9|1.2|
91484111|NCT01298544|182841597|SUPERIORITY_OR_OTHER||Difference in proportions|6.2|||||TWO_SIDED|95.0|1.8|13.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 23F||13.0|1.8|
91484112|NCT02160782|182841672|EQUIVALENCE|The P-value for testing if the treatment group least squares (LS) means were equal was calculated to determine if the change in sBA levels between the treatment groups was statistically significant.|Mean Difference (Net)|-117.28|STANDARD_ERROR_OF_MEAN|52.828||0.0464|TWO_SIDED|95.0|-232.38|-2.18|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in fasting sBA levels was evaluated using an analysis of covariance (ANCOVA) model with treatment group as a factor, and Week 18 sBA as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the MITT population, which included all participants who were enrolled, received study drug through Week 18, and had a reduction from baseline in sBA of ≥50% at the Week 12 or Week 18 measurement.||-2.18|-232.38|0.0464
91484113|NCT02160782|182841673|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-87.73|STANDARD_DEVIATION|119.979||0.0005|TWO_SIDED|95.0|-133.37|-42.09||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||-42.09|-133.37|0.0005
91632285|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-262.8|STANDARD_ERROR_OF_MEAN|301.1||0.39|TWO_SIDED|95.0|-877.8|352.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||352.1|-877.8|0.390
91484114|NCT02160782|182841674|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.704|STANDARD_DEVIATION|0.9114|<|0.0001|TWO_SIDED|95.0|-2.051|-1.357|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.357|-2.051|< 0.0001
91484115|NCT02160782|182841675|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Pt) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-2.072|STANDARD_DEVIATION|0.9931|<|0.0001|TWO_SIDED|95.0|-2.645|-1.498|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Pt) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.498|-2.645|< 0.0001
91527825|NCT06173570|182930686|SUPERIORITY||Mean Difference (Net)|-6.67||||0.256|TWO_SIDED|95.0|-18.17|4.84|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||4.84|-18.17|0.256
91632286|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-329.4|STANDARD_ERROR_OF_MEAN|302.97||0.286|TWO_SIDED|95.0|-948.1|289.4|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||289.4|-948.1|0.286
91632287|NCT00853112|183157523|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.7|STANDARD_ERROR_OF_MEAN|314.15||0.843|TWO_SIDED|95.0|-704.3|578.9|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||578.9|-704.3|0.843
91632288|NCT00853112|183157524|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|322.8||0.999|TWO_SIDED|95.0|-659.7|658.8|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||658.8|-659.7|0.999
91632289|NCT00853112|183157524|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|72.2|STANDARD_ERROR_OF_MEAN|309.69||0.817|TWO_SIDED|95.0|-560.2|704.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||704.7|-560.2|0.817
91632290|NCT00853112|183157524|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-82.6|STANDARD_ERROR_OF_MEAN|307.67||0.79|TWO_SIDED|95.0|-711.0|545.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||545.7|-711.0|0.790
91632291|NCT00853112|183157524|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-325.6|STANDARD_ERROR_OF_MEAN|309.58||0.301|TWO_SIDED|95.0|-957.8|306.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||306.7|-957.8|0.301
91632292|NCT00853112|183157524|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.2|STANDARD_ERROR_OF_MEAN|321.0||0.85|TWO_SIDED|95.0|-716.8|594.4|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||594.4|-716.8|0.850
91632293|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-269.32|STANDARD_ERROR_OF_MEAN|252.93||0.295|TWO_SIDED|95.0|-785.39|246.76|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||246.76|-785.39|0.295
91632294|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-97.65|STANDARD_ERROR_OF_MEAN|234.55||0.68|TWO_SIDED|95.0|-577.02|381.72|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||381.72|-577.02|0.680
91632295|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-376.61|STANDARD_ERROR_OF_MEAN|241.06||0.129|TWO_SIDED|95.0|-869.53|116.31|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||116.31|-869.53|0.129
91632296|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-342.29|STANDARD_ERROR_OF_MEAN|247.07||0.176|TWO_SIDED|95.0|-846.9|162.32|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||162.32|-846.90|0.176
91632297|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-316.86|STANDARD_ERROR_OF_MEAN|261.58||0.235|TWO_SIDED|95.0|-850.9|217.17|||Longitudinal analysis|||Hour 1: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||217.17|-850.90|0.235
91632298|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-198.06|STANDARD_ERROR_OF_MEAN|247.62||0.43|TWO_SIDED|95.0|-705.04|308.91|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||308.91|-705.04|0.430
91632299|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.9|STANDARD_ERROR_OF_MEAN|229.23||0.87|TWO_SIDED|95.0|-432.23|508.04|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||508.04|-432.23|0.870
91632300|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-114.06|STANDARD_ERROR_OF_MEAN|244.95||0.645|TWO_SIDED|95.0|-614.57|386.45|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||386.45|-614.57|0.645
91632301|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-299.6|STANDARD_ERROR_OF_MEAN|241.63||0.225|TWO_SIDED|95.0|-794.81|195.61|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||195.61|-794.81|0.225
91632302|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-332.25|STANDARD_ERROR_OF_MEAN|255.93||0.205|TWO_SIDED|95.0|-856.55|192.05|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||192.05|-856.55|0.205
91632303|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.72|STANDARD_ERROR_OF_MEAN|263.63||0.745|TWO_SIDED|95.0|-625.87|452.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||452.42|-625.87|0.745
91632304|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.0|STANDARD_ERROR_OF_MEAN|245.25||0.942|TWO_SIDED|95.0|-484.46|520.47|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||520.47|-484.46|0.942
91527493|NCT02597933|182930151|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.58||0.2727|TWO_SIDED|95.0|-0.51|1.79|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.79|-0.51|0.2727
91632305|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-265.94|STANDARD_ERROR_OF_MEAN|259.53||0.314|TWO_SIDED|95.0|-796.15|264.28|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||264.28|-796.15|0.314
91632306|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-275.35|STANDARD_ERROR_OF_MEAN|258.01||0.295|TWO_SIDED|95.0|-803.57|252.88|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||252.88|-803.57|0.295
91632307|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-326.55|STANDARD_ERROR_OF_MEAN|272.96||0.241|TWO_SIDED|95.0|-885.12|232.02|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||232.02|-885.12|0.241
91632308|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-145.71|STANDARD_ERROR_OF_MEAN|218.5||0.51|TWO_SIDED|95.0|-592.24|300.83|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||300.83|-592.24|0.510
91632309|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|77.96|STANDARD_ERROR_OF_MEAN|199.85||0.699|TWO_SIDED|95.0|-330.7|486.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||486.63|-330.70|0.699
91632310|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-341.91|STANDARD_ERROR_OF_MEAN|204.65||0.106|TWO_SIDED|95.0|-760.45|76.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||76.64|-760.45|0.106
91632311|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-289.41|STANDARD_ERROR_OF_MEAN|211.69||0.182|TWO_SIDED|95.0|-722.17|143.35|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||143.35|-722.17|0.182
91632312|NCT00853112|183157525|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-256.6|STANDARD_ERROR_OF_MEAN|224.88||0.263|TWO_SIDED|95.0|-716.26|203.06|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||203.06|-716.26|0.263
91632313|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-328.1|STANDARD_ERROR_OF_MEAN|385.78||0.401|TWO_SIDED|95.0|-1114.11|457.92|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||457.92|-1114.11|0.401
91632314|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-164.96|STANDARD_ERROR_OF_MEAN|370.54||0.659|TWO_SIDED|95.0|-920.05|590.12|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.12|-920.05|0.659
91666490|NCT05151471|183227031|SUPERIORITY|||||||0.704|||||||ANCOVA|||Week 72||||0.704
91484116|NCT02160782|182841676|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Obs) between the treatment groups was statistically significant.|Mean Difference (Net)|-1.483|STANDARD_ERROR_OF_MEAN|0.3103|<|0.0001|TWO_SIDED|95.0|-2.122|-0.844|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO(Obs) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Obs) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.844|-2.122|< 0.0001
91484117|NCT02160782|182841677|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Pt) between the treatment groups was statistically significant. While the number of participants included in analysis for the end point indicates 28, there were only 14; n = 5 for ItchRO(Pt): MRX and n = 9 for ItchRO(Pt): placebo.|Mean Difference (Net)|-1.988|STANDARD_ERROR_OF_MEAN|0.4641||0.0013|TWO_SIDED|95.0|-3.009|-0.967|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO (Pt) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Pt) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.967|-3.009|0.0013
91484118|NCT02160782|182841678|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-27.8|STANDARD_DEVIATION|118.33||0.2163|TWO_SIDED|95.0|-72.8|17.2||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||17.2|-72.8|0.2163
91484119|NCT02160782|182841679|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALP levels between the treatment groups was statistically significant.|Mean Difference (Net)|10.0|STANDARD_ERROR_OF_MEAN|30.44||0.7455|TWO_SIDED|95.0|-52.6|72.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALP levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALP as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||72.6|-52.6|0.7455
91484120|NCT02160782|182841680|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.3|STANDARD_DEVIATION|84.54||0.9358|TWO_SIDED|95.0|-33.4|30.9||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||30.9|-33.4|0.9358
91484121|NCT02160782|182841681|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALT levels between the treatment groups was statistically significant.|Mean Difference (Net)|15.1|STANDARD_ERROR_OF_MEAN|19.53||0.4472|TWO_SIDED|95.0|-25.1|55.2|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||55.2|-25.1|0.4472
91484122|NCT02160782|182841682|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.424||0.0893|TWO_SIDED|95.0|-1.01|0.08|||Student's t-test|||||0.08|-1.01|0.0893
91527494|NCT01097915|182930156|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
91527495|NCT01097915|182930157|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|||||||<0.004
91666491|NCT05151471|183227031|SUPERIORITY|||||||0.131|||||||ANCOVA|||Week 96||||0.131
91527496|NCT01097915|182930158|SUPERIORITY_OR_OTHER||||||<|0.048|||||||ANCOVA|the three factors of the Stunkard and Messick Questionnaire were considered as covariates.||||||<0.048
91632315|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-287.08|STANDARD_ERROR_OF_MEAN|372.6||0.447|TWO_SIDED|95.0|-1047.59|473.42|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||473.42|-1047.59|0.447
91632316|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-457.16|STANDARD_ERROR_OF_MEAN|374.26||0.231|TWO_SIDED|95.0|-1220.86|306.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||306.53|-1220.86|0.231
91632317|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-75.24|STANDARD_ERROR_OF_MEAN|384.2||0.846|TWO_SIDED|95.0|-858.19|707.71|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||707.71|-858.19|0.846
91666492|NCT05151471|183227032|SUPERIORITY|||||||0.954|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.954
91666493|NCT05151471|183227032|SUPERIORITY|||||||0.591|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.591
91666494|NCT05151471|183227033|SUPERIORITY|||||||0.513|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.513
91666495|NCT05151471|183227033|SUPERIORITY|||||||0.344|||||||Mixed Model for Repeated Measures (MMRM)|||Week 84||||0.344
91666496|NCT05151471|183227033|SUPERIORITY|||||||0.142|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.142
91666497|NCT04230174|183227037|OTHER|Paired-t test baseline vs follow-up SUVR in white matter lesions of multiple sclerosis patients.||||||0.011|||||||t-test, 2 sided|||||||0.011
91666498|NCT04230174|183227037|OTHER|Paired-t test||||||0.018|||||||t-test, 2 sided|||Paired-t test baseline vs follow-up SUVR in perilesional white matter multiple sclerosis patients.||||0.018
91484123|NCT02160782|182841683|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in total bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.361||0.7|TWO_SIDED|95.0|-0.88|0.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in total bilirubin was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 total bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.6|-0.88|0.7
91484124|NCT02160782|182841684|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.012||0.0139|TWO_SIDED|95.0|-0.9|-0.11|||Student's t-test|||||-0.11|-0.9|0.0139
91527497|NCT01097915|182930159|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
91632318|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-115.64|STANDARD_ERROR_OF_MEAN|357.2||0.748|TWO_SIDED|95.0|-844.24|612.96|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||612.96|-844.24|0.748
91632319|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|342.91||0.993|TWO_SIDED|95.0|-702.41|696.67|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.67|-702.41|0.993
91632320|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|174.2|STANDARD_ERROR_OF_MEAN|342.93||0.615|TWO_SIDED|95.0|-526.41|874.81|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||874.81|-526.41|0.615
91632321|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-494.91|STANDARD_ERROR_OF_MEAN|344.72||0.161|TWO_SIDED|95.0|-1199.04|209.21|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||209.21|-1199.04|0.161
91632322|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-134.48|STANDARD_ERROR_OF_MEAN|355.5||0.708|TWO_SIDED|95.0|-859.74|590.77|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.77|-859.74|0.708
91632323|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|47.61|STANDARD_ERROR_OF_MEAN|365.43||0.897|TWO_SIDED|95.0|-697.56|792.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||792.79|-697.56|0.897
91632324|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|98.42|STANDARD_ERROR_OF_MEAN|350.87||0.781|TWO_SIDED|95.0|-617.15|813.99|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||813.99|-617.15|0.781
91632325|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-28.31|STANDARD_ERROR_OF_MEAN|355.47||0.937|TWO_SIDED|95.0|-753.46|696.83|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.83|-753.46|0.937
91632326|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-369.57|STANDARD_ERROR_OF_MEAN|353.25||0.304|TWO_SIDED|95.0|-1090.86|351.72|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||351.72|-1090.86|0.304
91632327|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-185.64|STANDARD_ERROR_OF_MEAN|363.77||0.613|TWO_SIDED|95.0|-927.54|556.27|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||556.27|-927.54|0.613
91527498|NCT01097915|182930160|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
91527499|NCT01097915|182930161|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Chi-squared|||||||< 0.00001
91666499|NCT04230174|183227037|OTHER|Paired-t test||||||0.047|||||||t-test, 2 sided|||Paired-t test baseline vs follow-up SUVR in the thalamus of multiple sclerosis patients.|A general linear model using the FreeSurfer software was used to assess, vertex-wise, significant paired-wise SUVR differences in post vs pre ocrelizumab treatment in patients across the cortex. A clusterwise correction for multiple comparisons was also applied using a Monte-Carlo simulation with 10,000 iterations (corrected P ≤ 0.05). The surface-based analysis disclosed three clusters of decreased 11C-PBR28 uptake in the right hemisphere (Fig. 4), including insula (p=0.0009), lateral orbitofrontal (p=0.03), and opercular/frontal inferior (p=0.02) areas after adjusting for multiple comparisons.|||0.047
91632328|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|265.51|STANDARD_ERROR_OF_MEAN|324.88||0.42|TWO_SIDED|95.0|-397.45|928.48|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||928.48|-397.45|0.420
91632329|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|240.17|STANDARD_ERROR_OF_MEAN|311.63||0.447|TWO_SIDED|95.0|-395.81|876.14|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||876.14|-395.81|0.447
91632330|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-176.74|STANDARD_ERROR_OF_MEAN|309.11||0.572|TWO_SIDED|95.0|-808.1|454.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||454.63|-808.10|0.572
91632331|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.96|STANDARD_ERROR_OF_MEAN|311.11||0.929|TWO_SIDED|95.0|-663.31|607.38|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||607.38|-663.31|0.929
91632332|NCT00853112|183157526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|29.58|STANDARD_ERROR_OF_MEAN|323.01||0.928|TWO_SIDED|95.0|-629.62|688.79|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||688.79|-629.62|0.928
91632333|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.35|0.83|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.83|-0.35|0.412
91484125|NCT02160782|182841685|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in direct bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.265||0.9517|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in direct bilirubin levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 direct bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.53|-0.56|0.9517
91484126|NCT00729924|182841686|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The hypothesis was that the ratio of the 4-hour CSF concentration value to the partial plasma area-under-the-curve 0-4h value would differ between participants with ABCB1 C/C and T/T genotypes.||||0.43
91484127|NCT00729924|182841687|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||We explored post-hoc whether the ratio of the 4-hour CSF concentration value to the 2-hour plasma concentration differs between participants with ABCB1 C/C and T/T genotypes.||||0.43
91666500|NCT04230174|183227038|OTHER|Paired-t test||||||0.07|||||||t-test, 2 sided|||Baseline vs follow-up MTR in NAWM||||0.07
91666501|NCT04230174|183227038|OTHER|Paired-t test||||||0.024|||||||t-test, 2 sided|||Baseline vs follow-up MTR in cortex||||0.024
91666502|NCT04230174|183227039|OTHER|Paired-t test||||||0.69|||||||t-test, 2 sided|||Changes in cortical thickness after 1-year ocrelizumab treatment in patients with multiple sclerosis||||0.69
91666503|NCT04230174|183227040|OTHER|Wilcoxon related samples test||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon related samples test comparing baseline vs follow-up changes in white matter lesion volume of multiple sclerosis patients.||||0.64
91632334|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.999|TWO_SIDED|95.0|-0.58|0.58|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.58|-0.58|0.999
91632335|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.28||0.535|TWO_SIDED|95.0|-0.39|0.74|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.39|0.535
91632336|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28||0.128|TWO_SIDED|95.0|-0.13|1.01|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.01|-0.13|0.128
91632337|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.29||0.823|TWO_SIDED|95.0|-0.67|0.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.53|-0.67|0.823
91632338|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.34||0.396|TWO_SIDED|95.0|-0.4|0.99|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.99|-0.40|0.396
91632339|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.899|TWO_SIDED|95.0|-0.63|0.72|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.72|-0.63|0.899
91484128|NCT00413400|182841688|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANCOVA|||treatment effect (etanercept vs. placebo) using ANCOVA including baseline CRP, age, and race||||0.20
91632340|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.7|0.64|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.70|0.928
91632341|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.203|TWO_SIDED|95.0|-0.25|1.11|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.11|-0.25|0.203
91632342|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.772|TWO_SIDED|95.0|-0.6|0.8|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.60|0.772
91632343|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.29||0.771|TWO_SIDED|95.0|-0.52|0.69|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.69|-0.52|0.771
91666504|NCT04998136|183227041|SUPERIORITY||Treatment difference|-12.99|||<|0.0001|TWO_SIDED|95.0|-15.28|-10.7|||ANCOVA|||Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.||-10.70|-15.28|<0.0001
91666505|NCT04998136|183227042|SUPERIORITY||Treatment Difference|-13.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.11|||MMRM|||Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||-11.11|-15.70|<0.0001
91666506|NCT04998136|183227043|SUPERIORITY||Odds Ratio (OR)|88.87|||<|0.0001|TWO_SIDED|95.0|21.96|359.61|||Regression, Logistic|||Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.||359.61|21.96|<0.0001
91666507|NCT04998136|183227044|SUPERIORITY||Odds Ratio (OR)|253.47|||<|0.0001|TWO_SIDED|95.0|38.41|1672.57|||Regression, Logistic|||Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||1672.57|38.41|<0.0001
91632344|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.572|TWO_SIDED|95.0|-0.75|0.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.75|0.572
91632345|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.966|TWO_SIDED|95.0|-0.58|0.6|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.60|-0.58|0.966
91792440|NCT02047318|183462632|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-184.3|STANDARD_DEVIATION|322.22||0.22|TWO_SIDED|95.0|-522.5|153.8||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||153.8|-522.5|0.22
91792441|NCT02047318|183462633|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|51.6|STANDARD_DEVIATION|89.77||0.0307|TWO_SIDED|95.0|5.4|97.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||97.7|5.4|0.0307
91792442|NCT02047318|183462634|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|42.3|STANDARD_DEVIATION|140.41||0.4934|TWO_SIDED|95.0|-105.0|189.7||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||189.7|-105|0.4934
91792443|NCT02047318|183462635|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels between MRX baseline and Week 48 was statistically significant|Mean Difference (Net)|21.2|STANDARD_DEVIATION|58.98||0.1571|TWO_SIDED|95.0|-9.1|51.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||51.6|-9.1|0.1571
91484129|NCT00413400|182841689|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated for each timepoint and repeated measures ANCOVA controlling for age and race performed||||0.92
91484130|NCT00413400|182841690|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated Measures ANCOVA|||within subject percent changes were calculated for each time point, then repeated measures ANCOVA controlling for age and race performed||||0.02
91632346|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.28||0.157|TWO_SIDED|95.0|-0.17|1.0|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.00|-0.17|0.157
91666508|NCT03292458|183227074|SUPERIORITY|The primary efficacy outcome was analyzed using a restricted maximum likelihood (REML)-based linear mixed-effect model. The analysis included group, treatment, and treatment period as interacting fixed effects and subject as random effect. An unstructured covariance structure was used to model the within-patient errors.||||||0.01|TWO_SIDED|98.75|||||Mixed Models Analysis|||||||0.01
91792444|NCT02047318|183462636|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|12.2|STANDARD_DEVIATION|101.84||0.7815|TWO_SIDED|95.0|-94.7|119.0||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||119|-94.7|0.7815
91484131|NCT00413400|182841691|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||repeated measures ANCOVA|||percent change calculated then repeated measures ANCOVA performed controlling for age and race||||0.02
91484132|NCT00413400|182841692|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.46
91632347|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.3||0.546|TWO_SIDED|95.0|-0.43|0.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.79|-0.43|0.546
91632348|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.818|TWO_SIDED|95.0|-0.51|0.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.51|0.818
91632349|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.603|TWO_SIDED|95.0|-0.71|0.42|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.71|0.603
91666509|NCT03292458|183227075|OTHER|The minimum and average efficacy (in % symptom change) of sodium oxybate versus placebo in improving symptoms compared to the baseline was determined using binomial logistic regression.||||||0.05|TWO_SIDED|98.75|||||Regression, Logistic|||The minimum and average efficacy of sodium oxybate vs. placebo in improving symptoms compared to the baseline were determined using binomial logistic regression.||||0.05
91666510|NCT03292458|183227076|OTHER||Mean Difference (Final Values)|98.75||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
91666511|NCT03292458|183227077|OTHER|||||||0.01|TWO_SIDED|98.75|||||ANOVA|||||||0.01
91666512|NCT03292458|183227078|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
91484133|NCT00413400|182841693|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
91484134|NCT00413400|182841694|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
91632350|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.27||0.495|TWO_SIDED|95.0|-0.37|0.74|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.37|0.495
91632351|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.27||0.375|TWO_SIDED|95.0|-0.31|0.8|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.31|0.375
91632352|NCT00853112|183157527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.29||0.392|TWO_SIDED|95.0|-0.34|0.84|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.84|-0.34|0.392
91632353|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.75||0.21|TWO_SIDED|95.0|-12.47|2.86|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.86|-12.47|0.210
91632354|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|3.61||0.225|TWO_SIDED|95.0|-11.84|2.9|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.90|-11.84|0.225
91632355|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.73||0.332|TWO_SIDED|95.0|-11.28|3.93|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.93|-11.28|0.332
91632356|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.76||0.714|TWO_SIDED|95.0|-9.06|6.28|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.28|-9.06|0.714
91632357|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.01|STANDARD_ERROR_OF_MEAN|3.73||0.04|TWO_SIDED|95.0|-15.63|-0.39|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-0.39|-15.63|0.040
91632358|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|3.37||0.079|TWO_SIDED|95.0|-13.02|0.75|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.75|-13.02|0.079
91632359|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|3.24||0.573|TWO_SIDED|95.0|-8.46|4.77|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||4.77|-8.46|0.573
91632360|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.34||0.28|TWO_SIDED|95.0|-10.5|3.15|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.15|-10.50|0.280
91632361|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.38||0.684|TWO_SIDED|95.0|-8.28|5.51|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.51|-8.28|0.684
91632362|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|STANDARD_ERROR_OF_MEAN|3.35||0.021|TWO_SIDED|95.0|-15.01|-1.34|||Longitudinal analysis|||mPAP at Hour 2: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||-1.34|-15.01|0.021
91632363|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.7||0.727|TWO_SIDED|95.0|-8.86|6.25|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.25|-8.86|0.727
91632364|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|3.56||0.183|TWO_SIDED|95.0|-12.12|2.42|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.42|-12.12|0.183
91632365|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.01|STANDARD_ERROR_OF_MEAN|3.67||0.112|TWO_SIDED|95.0|-13.51|1.49|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.49|-13.51|0.112
91632366|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|3.71||0.928|TWO_SIDED|95.0|-7.91|7.23|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||7.23|-7.91|0.928
91632367|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.01|STANDARD_ERROR_OF_MEAN|3.68||0.02|TWO_SIDED|95.0|-16.52|-1.5|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.50|-16.52|0.020
91632368|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|3.79||0.136|TWO_SIDED|95.0|-13.55|1.94|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.94|-13.55|0.136
91632369|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|3.65||0.303|TWO_SIDED|95.0|-11.27|3.63|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.63|-11.27|0.303
91666513|NCT03292458|183227079|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
91666514|NCT01513239|183227080|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-5.1||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-5.1|-16.4|<0.0001
91666515|NCT01513239|183227080|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0003|TWO_SIDED|95.0|-15.5|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-4.3|-15.5|0.0003
91484135|NCT00413400|182841695|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.59
91632370|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.17|STANDARD_ERROR_OF_MEAN|3.77||0.18|TWO_SIDED|95.0|-12.87|2.52|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.52|-12.87|0.180
91632371|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|3.8||0.506|TWO_SIDED|95.0|-10.31|5.2|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.20|-10.31|0.506
91632372|NCT00853112|183157528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.84|STANDARD_ERROR_OF_MEAN|3.77||0.026|TWO_SIDED|95.0|-16.54|-1.14|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.14|-16.54|0.026
91666516|NCT01513239|183227080|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.8||||0.3718|TWO_SIDED|95.0|-5.9|4.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||4.2|-5.9|0.3718
91666517|NCT01513239|183227081|SUPERIORITY_OR_OTHER||Adjusted Difference|5.2||||0.0722|TWO_SIDED|95.0|-1.8|12.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||12.2|-1.8|0.0722
91666518|NCT01513239|183227081|SUPERIORITY_OR_OTHER||Adjusted Difference|14.6|||<|0.0001|TWO_SIDED|95.0|7.7|21.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||21.4|7.7|<0.0001
91484136|NCT00413400|182841696|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Repeated measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA controlling for age and race performed||||<0.0001
91484137|NCT00413400|182841697|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA performed controlling for age and race||||0.08
91632373|NCT01553591|183157536|SUPERIORITY|||||||0.014||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.014
91632374|NCT01553591|183157536|SUPERIORITY|||||||0.004||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.004
91666519|NCT01513239|183227081|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.4||||0.9969|TWO_SIDED|95.0|-16.1|-2.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||-2.7|-16.1|0.9969
91666520|NCT01513239|183227082|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.9||||0.0006|TWO_SIDED|95.0|-19.0|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-4.7|-19.0|0.0006
91484138|NCT00413400|182841698|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, and race||||0.55
91484139|NCT00891462|182841712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.13|||ANCOVA|||||0.13|0.05|<0.0001
91484140|NCT00891462|182841712|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.124|||<|0.0001|TWO_SIDED|95.0|0.08|0.16|||ANCOVA|||||0.16|0.08|<0.0001
91527826|NCT06173570|182930686|SUPERIORITY||Mean Difference (Net)|-7.63||||0.186|TWO_SIDED|95.0|-18.95|3.69|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||3.69|-18.95|0.186
91632375|NCT01553591|183157537|SUPERIORITY|||||||0.112||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.112
91632376|NCT01553591|183157537|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
91632377|NCT02477800|183157551|SUPERIORITY||Difference from Placebo|0.11||||0.225|TWO_SIDED|95.0|-0.469|0.403|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.403|-0.469|0.2250
91666521|NCT01513239|183227082|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-20.4|-6.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-6.9|-20.4|<0.0001
91666522|NCT01513239|183227082|SUPERIORITY_OR_OTHER||Adjusted Difference|1.6||||0.6962|TWO_SIDED|95.0|-4.6|8.0||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||8.0|-4.6|0.6962
91666523|NCT01513239|183227083|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.9||||0.408|TWO_SIDED|95.0|-9.8|4.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo +SOC|||4.0|-9.8|0.408
91666524|NCT01513239|183227083|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.3||||0.517|TWO_SIDED|95.0|-9.2|4.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||4.6|-9.2|0.517
91666525|NCT01513239|183227084|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2||||0.931|TWO_SIDED|95.0|-3.8|3.5|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||3.5|-3.8|0.931
91666526|NCT01513239|183227084|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0||||0.997|TWO_SIDED|95.0|-3.7|3.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||3.6|-3.7|0.997
91632378|NCT02477800|183157551|SUPERIORITY||Difference from late start group|0.03||||0.833|TWO_SIDED|95.0|-0.262|0.326|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.326|-0.262|0.8330
91792445|NCT02047318|183462637|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-3.9|STANDARD_DEVIATION|257.78||0.9513|TWO_SIDED|95.0|-136.4|128.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||128.7|-136.4|0.9513
91792446|NCT02047318|183462638|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-56.7|STANDARD_DEVIATION|356.88||0.7133|TWO_SIDED|95.0|-431.2|317.9||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||317.9|-431.2|0.7133
91484141|NCT01083485|182841726|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||A P value was not part of the analysis plan. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin was -1.0 meaning that OXN PR can be one unit inferior to OXY PR and still be considered non-inferior.|ANCOVA|The primary efficacy endpoint was analysed on the PP data using a mixed-model repeat measure analysis of covariance RMANCOVA.||The sample size was calculated for a significance level of 2.5% (1 sided) with 90% power. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin of 1.0 were assumed.||0.3|-0.5|
91792447|NCT02047318|183462639|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|2.348||0.7839|TWO_SIDED|95.0|-1.05|1.37||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||1.37|-1.05|0.7839
91484142|NCT01948310|182841747|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
91484143|NCT01948310|182841747|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||0-14 weeks||||0.03
91484144|NCT01948310|182841747|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
91484145|NCT01948310|182841747|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||14-0 weeks||||0.005
91484146|NCT01948310|182841748|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
91484147|NCT01948310|182841748|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
91484148|NCT01948310|182841748|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||2-0 weeks||||0.03
91484149|NCT01948310|182841748|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
91484150|NCT01948310|182841749|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
91484151|NCT01948310|182841749|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||0-14 weeks||||0.13
91484152|NCT01948310|182841749|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
91484153|NCT01948310|182841749|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||14-0 weeks||||0.013
91484154|NCT05015530|182841761|SUPERIORITY|||||||0.908|||||||Kruskal-Wallis|||α-diversity assessed using the Kruskal-Wallis test||||0.908
91484155|NCT02600351|182841813|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.|Difference in percentages|-18.8||||0.065|TWO_SIDED|95.0|-40.7|3.2|||Cochran-Mantel-Haenszel|||||3.2|-40.7|0.065
91632379|NCT02477800|183157552|SUPERIORITY||Difference from Placebo|0.2||||0.4795|TWO_SIDED|95.0|-0.35|0.74|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.74|-0.35|0.4795
91632380|NCT02477800|183157552|SUPERIORITY||Difference from Placebo|-0.1||||0.8106|TWO_SIDED|95.0|-0.62|0.49|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.49|-0.62|0.8106
91632381|NCT02477800|183157553|SUPERIORITY||Difference from Placebo|-0.583||||0.2536|TWO_SIDED|95.0|-1.5835|0.4181|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4181|-1.5835|0.2536
91484156|NCT02600351|182841813|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.|Difference in percentages|-11.7||||0.25|TWO_SIDED|95.0|-32.1|8.8|||Cochran-Mantel-Haenszel|||||8.8|-32.1|0.25
91484157|NCT00567593|182841822|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test||||||.01
91484158|NCT01272284|182841858|SUPERIORITY_OR_OTHER_LEGACY||Proportion successful|85.4|||<|0.0001|ONE_SIDED|95.81|78.1||||Fisher Exact|||The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.|||78.1|<0.0001
91632382|NCT02477800|183157553|SUPERIORITY||Difference from Placebo|-0.588||||0.2578|TWO_SIDED|95.0|-1.6067|0.4309|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4309|-1.6067|0.2578
91632383|NCT02477800|183157554|SUPERIORITY||Difference from Placebo|0.7||||0.1225|TWO_SIDED|95.0|-0.19|1.64|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.64|-0.19|0.1225
91632384|NCT02477800|183157554|SUPERIORITY||Difference from late start group|0.7||||0.1506|TWO_SIDED|95.0|-0.25|1.61|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.61|-0.25|0.1506
91632385|NCT00423592|183157556|SUPERIORITY_OR_OTHER||Proportion|0.0|STANDARD_DEVIATION|0.0||0.01|TWO_SIDED|95.0|0.0|9.7|||Exact binomial test|A 1-sample test for a binomial proportion was performed.||Sample size: 30 participants; 80% power to rule out 50% recurrence rate of serum ALT/AST abnormalities following ambrisentan treatment (assumes 25% recurrence rate); 99% power to rule out 75% recurrence rate (assumes 37.5% recurrence rate). H\_0 = proportion of subjects experiencing primary endpoint at 12% vs 1-sided alternative of \< 12%. P-value from exact binomial test. Summary statistics included the estimated proportion, 95% confidence interval (CI), and the p-value of the hypothesis test.||9.7|0.0|0.01
91632386|NCT00423592|183157559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|STANDARD_DEVIATION|49.6||0.009|TWO_SIDED|95.0|6.3|40.4|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) 6-minute walk distance change from baseline.||40.4|6.3|0.009
91632387|NCT00423592|183157560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.51||0.046|TWO_SIDED|95.0|-1.0|0.0|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) Borg dyspnea index change from baseline.||0.0|-1.0|0.046
91632388|NCT00423592|183157562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_DEVIATION|6.44||0.001|TWO_SIDED|95.0|2.1|7.1|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.1|2.1|0.001
91666527|NCT01513239|183227085|SUPERIORITY_OR_OTHER||Difference in Percentages|0.5||||0.328|TWO_SIDED|95.0|-0.8|2.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||2.0|-0.8|0.328
91484159|NCT01086423|182841875|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.68|||||TWO_SIDED|95.0|-1.88|3.76||||||To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.||3.76|-1.88|
91632389|NCT00423592|183157563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|8.98||0.059|TWO_SIDED|95.0|-0.1|6.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.8|-0.1|0.059
91632390|NCT00423592|183157564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_DEVIATION|6.86||0.002|TWO_SIDED|95.0|1.7|7.0|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.0|1.7|0.002
91484160|NCT01086423|182841875|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.56|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.||2.56|-2.56|
91666528|NCT01513239|183227085|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.3||||0.308|TWO_SIDED|95.0|-1.5|0.7|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||0.7|-1.5|0.308
91666529|NCT01513239|183227086|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
91484161|NCT01086423|182841876|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-7.93|||||TWO_SIDED|95.0|-14.44|-2.13||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.||-2.13|-14.44|
91484162|NCT01086423|182841877|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.||2.56|-2.51|
91484163|NCT01086423|182841877|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.||2.56|-2.51|
91527827|NCT06173570|182930686|SUPERIORITY||Mean Difference (Net)|-10.0||||0.086|TWO_SIDED|95.0|-21.44|1.43|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||1.43|-21.44|0.086
91632391|NCT00423592|183157565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|10.56||0.001|TWO_SIDED|95.0|3.1|11.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||11.3|3.1|0.001
91632392|NCT00423592|183157566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.4||0.017|TWO_SIDED|95.0|0.6|5.6|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.6|0.6|0.017
91632393|NCT00423592|183157567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.45||0.046|TWO_SIDED|95.0|0.1|5.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.8|0.1|0.046
91632394|NCT00423592|183157568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|7.23||0.003|TWO_SIDED|95.0|1.7|7.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.3|1.7|0.003
91632395|NCT00423592|183157569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|9.41||0.059|TWO_SIDED|95.0|-0.1|7.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.2|-0.1|0.059
91632396|NCT00423592|183157570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|13.96||0.152|TWO_SIDED|95.0|-1.5|9.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||9.3|-1.5|0.152
91632397|NCT00423592|183157571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|5.78||0.001|TWO_SIDED|95.0|1.7|6.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.2|1.7|0.001
91632398|NCT00062647|183157572|NON_INFERIORITY_OR_EQUIVALENCE|No margin was justified owing to the exploratory nature of the investigation.|Risk Difference (RD)|1.0||||||95.0|-35.5|31.9|||the difference in the 2 eradication rate|Statistical testing was limited to interval estimation (95% CI) of the difference in the 2 eradication rates using the method of Agresti and Caffo.||||31.9|-35.5|
91632399|NCT00255008|183157582|SUPERIORITY_OR_OTHER||Proportion of patients (%)|80.0||||||95.0|28.36|99.49||||||||99.49|28.36|
91632400|NCT00255008|183157582|SUPERIORITY_OR_OTHER||Proportion of patients (%)|76.47||||||95.0|50.1|93.19||||||||93.19|50.10|
91632401|NCT00255008|183157582|SUPERIORITY_OR_OTHER||Proportion of patients (%)|87.5||||||95.0|47.35|99.48||||||||99.48|47.35|
91632402|NCT02583360|183157589|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
91632403|NCT02583360|183157590|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||||||0.907
91632404|NCT02583360|183157591|SUPERIORITY|||||||0.592|||||||t-test, 2 sided|||||||0.592
91632405|NCT01855919|183157634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0026|TWO_SIDED|95.0|-0.77|-0.16|||Mixed Models Analysis|||||-0.16|-0.77|0.0026
91632406|NCT01855919|183157635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0026|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|0.0026
91632407|NCT01855919|183157636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0439|TWO_SIDED|95.0|-1.25|-0.02|||ANCOVA|||||-0.02|-1.25|0.0439
91632408|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.101|TWO_SIDED|95.0|-0.66|0.06||p-value is for worst pain|Mixed Models Analysis|||||0.06|-0.66|0.1010
91632409|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0009|TWO_SIDED|95.0|-0.79|-0.21||p-value is for least pain|Mixed Models Analysis|||||-0.21|-0.79|0.0009
91632410|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.023|TWO_SIDED|95.0|-0.74|-0.05||p-value is for Pain Right Now|Mixed Models Analysis|||||-0.05|-0.74|0.0230
91632411|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0874|TWO_SIDED|95.0|-0.66|0.05||p-value is for General Activity|Mixed Models Analysis|||||0.05|-0.66|0.0874
91632412|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0436|TWO_SIDED|95.0|-0.63|-0.01||p-value is for Mood|Mixed Models Analysis|||||-0.01|-0.63|0.0436
91632413|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3902|TWO_SIDED|95.0|-0.45|0.18||p-value is for Walking Ability|Mixed Models Analysis|||||0.18|-0.45|0.3902
91632414|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.33|0.33||p-value is for Normal Work|Mixed Models Analysis|||||0.33|-0.33|0.9910
91632415|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7848|TWO_SIDED|95.0|-0.3|0.23||p-value is for Relationship People|Mixed Models Analysis|||||0.23|-0.30|0.7848
91632416|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9424|TWO_SIDED|95.0|-0.32|0.3||p-value is for Sleep|Mixed Models Analysis|||||0.30|-0.32|0.9424
91632417|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7932|TWO_SIDED|95.0|-0.35|0.27||p-value is for Enjoyment of Life|Mixed Models Analysis|||||0.27|-0.35|0.7932
91632418|NCT01855919|183157637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3761|TWO_SIDED|95.0|-0.4|0.15||p-value is for Average of 7 Items|Mixed Models Analysis|||||0.15|-0.40|0.3761
91632419|NCT01855919|183157638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0049|TWO_SIDED|95.0|-0.71|-0.13||p-value is for Average Pain|Mixed Models Analysis|||||-0.13|-0.71|0.0049
91632420|NCT01855919|183157638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0442|TWO_SIDED|95.0|-0.69|-0.01||p-value is for Worst pain|Mixed Models Analysis|||||-0.01|-0.69|0.0442
91632421|NCT01855919|183157639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.0003|TWO_SIDED|95.0|1.13|1.53||p-value is for ≥30%|Mantel Haenszel|||||1.53|1.13|0.0003
91632422|NCT01855919|183157639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.0003|TWO_SIDED|95.0|1.18|1.75||p-value is for ≥50%|Mantel Haenszel|||||1.75|1.18|0.0003
91632423|NCT01855919|183157640|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.33||||0.0012|TWO_SIDED|95.0|1.12|1.58|||Mantel Haenszel|||||1.58|1.12|0.0012
91632424|NCT01855919|183157641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0019|TWO_SIDED|95.0|-0.46|-0.1|||Mixed Models Analysis|||||-0.10|-0.46|0.0019
91632425|NCT01855919|183157642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.3012|TWO_SIDED|95.0|-1.03|0.32|||ANCOVA|||||0.32|-1.03|0.3012
91632426|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.2581|TWO_SIDED|95.0|-0.93|3.47||p-value for Physical Functioning|ANCOVA|||||3.47|-0.93|0.2581
91632427|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.7208|TWO_SIDED|95.0|-2.62|3.79||p-value for Role (Physical)|ANCOVA|||||3.79|-2.62|0.7208
91632428|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55||||0.2487|TWO_SIDED|95.0|-1.09|4.19||p-value for Bodily Pain|ANCOVA|||||4.19|-1.09|0.2487
91632429|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.0151|TWO_SIDED|95.0|0.57|5.31||p-value for General Health|ANCOVA|||||5.31|0.57|0.0151
91632430|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.4|TWO_SIDED|95.0|-1.54|3.85||p-value for Vitality|ANCOVA|||||3.85|-1.54|0.4000
91632431|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.2529|TWO_SIDED|95.0|-1.17|4.43||p-value for Social Functioning|ANCOVA|||||4.43|-1.17|0.2529
91632432|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8042|TWO_SIDED|95.0|-3.55|2.75||p-value for Role(Emotional)|ANCOVA|||||2.75|-3.55|0.8042
91632433|NCT01855919|183157643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0058|TWO_SIDED|95.0|0.94|5.48||p-value is for Mental Health|ANCOVA|||||5.48|0.94|0.0058
91632434|NCT01855919|183157644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.5237|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA|||||0.03|-0.02|0.5237
91632435|NCT01855919|183157645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.046|TWO_SIDED|95.0|-0.05|0.0||p-value for Work time missed|ANCOVA|||||0.00|-0.05|0.0460
91632436|NCT01855919|183157645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0753|TWO_SIDED|95.0|-0.08|0.0||p-value for Impairment at work|ANCOVA|||||0.00|-0.08|0.0753
91632437|NCT01855919|183157645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0795|TWO_SIDED|95.0|-0.08|0.0||p-value for Work productivity loss|ANCOVA|||||0.00|-0.08|0.0795
91632438|NCT01855919|183157645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.1466|TWO_SIDED|95.0|-0.06|0.01||p-value for Work activity impairment|ANCOVA|||||0.01|-0.06|0.1466
91632439|NCT03455530|183157653|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|0.45|1.19|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||1.19|0.45|
91632440|NCT03455530|183157653|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.55|3.24|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||3.24|0.55|
91632441|NCT00908895|183157657|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|70.0|STANDARD_DEVIATION|25.0|<|0.05||95.0|||||Chi-squared|||We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.||||<0.05
91632442|NCT00908895|183157658|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|90.0|STANDARD_DEVIATION|10.0|<|0.05||95.0|80.0|100.0|||Chi-squared|||||100|80|<0.05
91632443|NCT03350724|183157659|SUPERIORITY|||||||0.039||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.039
91632444|NCT03350724|183157660|SUPERIORITY|||||||0.037||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.037
91632445|NCT03350724|183157661|SUPERIORITY|||||||0.032|||||||Z-Test for Two Population Proportions|||||||0.032
91632446|NCT03350724|183157662|SUPERIORITY|||||||0.171||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.171
91484164|NCT01086423|182841877|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.||2.56|-2.51|
91484165|NCT01086423|182841878|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.68|||||TWO_SIDED|95.0|-3.74|1.89||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.||1.89|-3.74|
91632447|NCT03350724|183157663|SUPERIORITY|||||||0.484||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.484
91632448|NCT03350724|183157664|SUPERIORITY|||||||0.368||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.368
91632449|NCT03350724|183157665|SUPERIORITY|||||||0.308||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.308
91632450|NCT03350724|183157666|SUPERIORITY|||||||0.999||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.999
91632451|NCT03350724|183157667|SUPERIORITY|||||||0.015||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.015
91632452|NCT03350724|183157668|SUPERIORITY|||||||0.021||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.021
91666530|NCT01513239|183227086|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
91666531|NCT01513239|183227087|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.4|||||TWO_SIDED|95.0|-4.2|3.3|||||MK-3415A + SOC minus Placebo + SOC|||3.3|-4.2|
91525789|NCT03587142|182927103|SUPERIORITY||Mean Difference (Net)|0.32||||0.18|TWO_SIDED|95.0|-0.15|0.79||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.79|-0.15|0.18
91632453|NCT03350724|183157669|SUPERIORITY|||||||0.035||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.035
91632454|NCT03350724|183157670|SUPERIORITY|||||||0.444||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.444
91632455|NCT03350724|183157671|SUPERIORITY|||||||0.765||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.765
91632456|NCT03350724|183157672|SUPERIORITY|||||||0.941||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.941
91632457|NCT03350724|183157673|SUPERIORITY|||||||0.421||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.421
91632458|NCT03350724|183157674|SUPERIORITY|||||||0.357||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.357
91632459|NCT03350724|183157675|SUPERIORITY|||||||0.22||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.22
91632460|NCT03350724|183157676|SUPERIORITY|||||||0.882||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.882
91632461|NCT03350724|183157677|SUPERIORITY|||||||0.64||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.64
91632462|NCT03350724|183157678|SUPERIORITY|||||||0.967||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.967
91632463|NCT03350724|183157679|SUPERIORITY|||||||0.375||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.375
91632464|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.26||0.309|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the motivational interviewing (MI) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.309
91666532|NCT01513239|183227087|SUPERIORITY_OR_OTHER||Difference in Percentages|1.2|||||TWO_SIDED|95.0|-2.7|5.2|||||MK-6072 + SOC minus Placebo + SOC|||5.2|-2.7|
91666533|NCT00396162|183227094|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
91666534|NCT00396162|183227095|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||||||.31
91666535|NCT01911429|183227113|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-8.0||||0.0003|TWO_SIDED|95.0|-12.4|-3.7|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.7|-12.4|0.0003
91666536|NCT01911429|183227113|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-7.7||||0.0006|TWO_SIDED|95.0|-12.1|-3.4|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.4|-12.1|0.0006
91484166|NCT01086423|182841878|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-2.7|||||TWO_SIDED|95.0|-6.75|-0.11||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.||-0.11|-6.75|
91484167|NCT01086423|182841878|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.67|||||TWO_SIDED|95.0|-4.6|3.04||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.||3.04|-4.6|
91632465|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.19|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the personalized recommendation (PR) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.190
91632466|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.69|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the psychoeducation (PE) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.690
91666537|NCT01911429|183227114|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.47||||0.0003|TWO_SIDED|95.0|-0.73|-0.22|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.22|-0.73|0.0003
91666538|NCT01911429|183227114|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.42||||0.0015|TWO_SIDED|95.0|-0.67|-0.16|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.16|-0.67|0.0015
91666539|NCT05908162|183227173|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91666540|NCT05908162|183227174|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91666541|NCT05908162|183227174|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91666542|NCT05908162|183227174|OTHER||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|||||||<0.02
91666543|NCT04442503|183227209|SUPERIORITY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.16||0.0007|TWO_SIDED|95.0|-6.3|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-6.3|0.0007
91666544|NCT04442503|183227210|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.999||0.0008|TWO_SIDED|95.0|-5.4|-1.4|||MMRM|||Change from Baseline at Day 3||-1.4|-5.4|0.0008
91666545|NCT04442503|183227210|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.244||0.0203|TWO_SIDED|95.0|-5.4|-0.5|||MMRM|||Change from Baseline at Day 28||-0.5|-5.4|0.0203
91666546|NCT04442503|183227210|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.277||0.0067|TWO_SIDED|95.0|-6.0|-1.0|||MMRM|||Change from Baseline at Day 45||-1.0|-6.0|0.0067
91525790|NCT03587142|182927104|SUPERIORITY||Mean Difference (Net)|1.01||||0.19|TWO_SIDED|95.0|-0.49|2.51||P value is nominal: no adjustments made from multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002.|ANCOVA|||Adjusted mean difference from differences (DoD) from the baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P value (2-sided) determined from a Wald Chi-Square test.||2.51|-0.49|0.19
91666547|NCT04442503|183227211|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.196||0.0052|TWO_SIDED|95.0|-0.9|-0.2|||MMRM|||Change from Baseline at Day 15||-0.2|-0.9|0.0052
91666548|NCT04442503|183227212|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0209|TWO_SIDED|95.0|1.112|3.67||P-value are from a generalized estimating equation (GEE) for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.670|1.112|0.0209
91666549|NCT04442503|183227212|SUPERIORITY||Odds Ratio (OR)|1.534||||0.1661|TWO_SIDED|95.0|0.837|2.812||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||2.812|0.837|0.1661
91484168|NCT02652767|182841888|SUPERIORITY||Mean Difference (Net)|-0.012||||0.889|TWO_SIDED|95.0|-0.182|0.158|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.158|-0.182|0.8890
91484169|NCT01130103|182841900|SUPERIORITY_OR_OTHER||incident rate ratio|0.5||||0.01|TWO_SIDED|95.0|0.3|0.85|||Mixed Models Analysis|||caps total score at weeks 5 and 10||.85|.30|.01
91484170|NCT01130103|182841900|SUPERIORITY_OR_OTHER||incident rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.43|0.74|||Mixed Models Analysis|||rate of change in CAPS total from week 5 to week 10||.74|.43|<.001
91484171|NCT01130103|182841904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.6||||0.03|TWO_SIDED|95.0|1.23|129.0|||Mixed Models Analysis|||treatment group effect: remission rate at weeks 5 and 10||129|1.23|.03
91484172|NCT01130103|182841904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.8||||0.007|TWO_SIDED|95.0|2.44|176.0|||Mixed Models Analysis|||rate of change over time in remission rate from week 5 to 10||176|2.44|0.007
91666550|NCT04442503|183227213|SUPERIORITY||Odds Ratio (OR)|1.781||||0.111|TWO_SIDED|95.0|0.876|3.621||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.621|0.876|0.1110
91666551|NCT04442503|183227213|SUPERIORITY||Odds Ratio (OR)|2.083||||0.0226|TWO_SIDED|95.0|1.108|3.915||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||3.915|1.108|0.0226
91666552|NCT04442503|183227214|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0089|TWO_SIDED|95.0|1.223|4.072|||MMRM|||Day 15||4.072|1.223|0.0089
91666553|NCT04442503|183227215|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.98||0.0235|TWO_SIDED|95.0|-4.2|-0.3|||MMRM|||Change from Baseline at Day 15||-0.3|-4.2|0.0235
91666554|NCT04442503|183227216|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.706||0.0034|TWO_SIDED|95.0|-8.4|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-8.4|0.0034
91484173|NCT03091777|182841934|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
91484174|NCT03091777|182841934|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
91484175|NCT00089674|182841935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.0001||95.0|6.2|7.1|||ANCOVA|||||7.1|6.2|<0.0001
91484176|NCT00089674|182841936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.0001||95.0|3.5|4.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||4.4|3.5|<0.0001
91484177|NCT00089674|182841937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|||<|0.0001||95.0|4.4|5.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.1|4.4|<0.0001
91527828|NCT06173570|182930687|SUPERIORITY||Mean Difference (Net)|-30.38|||<|0.001|TWO_SIDED|95.0|-38.63|-22.12|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-22.12|-38.63|< 0.001
91484178|NCT00089674|182841938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|7.4|8.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||8.4|7.4|<0.0001
91484179|NCT00089674|182841939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|||<|0.0001||95.0|4.4|5.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.4|4.4|<0.0001
91484180|NCT00089674|182841940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|||<|0.0001||95.0|5.4|6.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||6.1|5.4|<0.0001
91484181|NCT00089674|182841941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.1048||95.0|0.46|1.08||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.08|0.46|0.1048
91484182|NCT00089674|182841942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0125||95.0|0.18|0.78||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||0.78|0.18|0.0125
91666555|NCT04442503|183227217|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.4||0.0151|TWO_SIDED|95.0|-10.6|-1.2|||MMRM|||Change from Baseline in Core Subscale at Day 15||-1.2|-10.6|0.0151
91666556|NCT04442503|183227217|SUPERIORITY||LS Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|2.27||0.0123|TWO_SIDED|95.0|-10.2|-1.3|||MMRM|||Change from Baseline in Anxiety Subscale at Day 15||-1.3|-10.2|0.0123
91666557|NCT04442503|183227217|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|2.96||0.004|TWO_SIDED|95.0|-14.5|-2.8|||MMRM|||Change from Baseline in Bech-6 Subscale at Day 15||-2.8|-14.5|0.0040
91666558|NCT04442503|183227217|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.609||0.0041|TWO_SIDED|95.0|-12.7|-2.4|||MMRM|||Change from Baseline in Meier Subscale at Day 15||-2.4|-12.7|0.0041
91666559|NCT04442503|183227219|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.649||0.6912|TWO_SIDED|95.0|-1.0|1.5|||MMRM|||Change from Baseline at Day 3||1.5|-1.0|0.6912
91666560|NCT04442503|183227219|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.874||0.041|TWO_SIDED|95.0|-3.5|-0.1|||MMRM|||Change from Baseline at Day 8||-0.1|-3.5|0.0410
91666561|NCT04442503|183227219|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.922||0.0444|TWO_SIDED|95.0|-3.7|0.0|||MMRM|||Change from Baseline at Day 15||0.0|-3.7|0.0444
91666562|NCT04442503|183227219|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.924||0.0811|TWO_SIDED|95.0|-3.4|0.2|||MMRM|||Change from Baseline at Day 21||0.2|-3.4|0.0811
91666563|NCT04442503|183227219|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.987||0.1846|TWO_SIDED|95.0|-3.3|0.6|||MMRM|||Change from Baseline at Day 28||0.6|-3.3|0.1846
91632467|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.038|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the repeated administration (RA) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||0.038
91632468|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.735|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.735
91632469|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.91|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.001
91632470|NCT04806165|183157695|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.014|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.014
91666564|NCT04442503|183227219|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.031||0.0625|TWO_SIDED|95.0|-4.0|0.1|||MMRM|||Change from Baseline at Day 45||0.1|-4.0|0.0625
91666565|NCT00474058|183227249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55||||0.0002||95.0|-5.37|-1.73||No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-1.73|-5.37|0.0002
91666566|NCT00474058|183227250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26|||<|0.0001||95.0|-6.08|-2.45||No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-2.45|-6.08|<0.0001
91484183|NCT00089674|182841943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.7961||95.0|0.57|1.55||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Cox|||||1.55|0.57|0.7961
91666567|NCT00474058|183227251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0301||95.0|-0.79|-0.04|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-0.04|-0.79|0.0301
91666568|NCT00474058|183227252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8842||95.0|-0.29|0.25|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||0.25|-0.29|0.8842
91666569|NCT02640235|183227257|NON_INFERIORITY|The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel.|Difference in avg predicted proportion|-8.5|||||TWO_SIDED|95.0|-15.6|-1.4|||Regression, Logistic|||||-1.4|-15.6|
91484184|NCT00089674|182841944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.7961||95.0|0.44|1.11||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.11|0.44|0.7961
91484185|NCT01476644|182841966|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Regression, Linear|||||||<0.01
91484186|NCT04105543|182841975|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.22||||0.173|TWO_SIDED|95.0|-12.64|4.24|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for MDADI Composite Baseline to 3 months (n=9)||4.24|-12.64|0.173
91666570|NCT02640235|183227260|OTHER||Difference in avg predicted proportion|4.7|||||TWO_SIDED|95.0|-3.6|13.1|||Regression, Logistic|||||13.1|-3.6|
91666571|NCT02640235|183227261|OTHER||Difference in avg predicted proportion|-6.2|||||TWO_SIDED|95.0|-12.0|-0.5|||Regression, Logistic|||||-0.5|-12|
91666572|NCT02640235|183227262|OTHER||Difference in avg predicted proportion|-0.7|||||TWO_SIDED|95.0|-5.7|4.3|||Regression, Logistic|||||4.3|-5.7|
91666573|NCT02640235|183227263|OTHER||Difference in avg predicted proportion|0.2|||||TWO_SIDED|95.0|-3.9|4.4|||Regression, Logistic|||||4.4|-3.9|
91666574|NCT02426918|183227265|NON_INFERIORITY|Non-inferiority for the low dose was confirmed if the upper bound of the CI was \< 15% and if non-inferiority was confirmed for the high dose.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-11.42|3.0||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||3.00|-11.42|
91666575|NCT02426918|183227265|NON_INFERIORITY|Non-inferiority for the high dose was confirmed if the upper bound of the CI was \< 15%.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-8.32|8.38||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||8.38|-8.32|
91666576|NCT01322633|183227270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.24|1.93||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.93|0.24|
91666577|NCT01322633|183227271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.65|1.4||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.40|0.65|
91666578|NCT01322633|183227272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.21||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.21|0.93|
91666579|NCT02420353|183227273|OTHER|||||||0.0498|||||||Mixed Models Analysis|||Mixed effect model||||0.0498
91666580|NCT02420353|183227274|OTHER|Mixed effects model||||||0.7024|||||||Mixed Models Analysis|||||||0.7024
91666581|NCT02420353|183227275|OTHER|Mixed effects model||||||0.135|||||||Mixed Models Analysis|||||||0.135
91666582|NCT02420353|183227276|OTHER|Mixed effects model||||||0.6836|||||||Mixed Models Analysis|||||||0.6836
91666583|NCT02420353|183227277|OTHER|mixed effects model||||||0.9271|||||||Mixed Models Analysis|||||||0.9271
91666584|NCT02420353|183227278|OTHER|mixed effects model||||||0.1576|||||||Mixed Models Analysis|||||||0.1576
91666585|NCT02420353|183227279|OTHER|mixed effects model||||||0.5586|||||||Mixed Models Analysis|||||||0.5586
91666586|NCT02420353|183227280|OTHER|mixed effects model||||||0.45|||||||Mixed Models Analysis|||||||0.45
91484187|NCT04105543|182841975|OTHER|nonparametric rank test|Median Difference (Final Values)|-9.998||||0.225|TWO_SIDED|95.0|-28.43|7.39|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for MDADI Composite Baseline to 6 months (n=5)||7.39|-28.43|0.225
91484188|NCT04105543|182841976|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.037||||0.779|TWO_SIDED|95.0|-0.246|0.09|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for Stimulated Saliva Flow Baseline to 3 months (n=8)||0.09|-0.246|0.779
91484189|NCT04105543|182841976|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.049||||0.465|TWO_SIDED|95.0|-0.218|0.12|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Stimulated Saliva Flow Baseline to 6 months (n=4)||0.12|-0.218|0.465
91484190|NCT04105543|182841977|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.444||||0.213|TWO_SIDED|95.0|-14.4|4.4|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Functional Score Baseline to 3 months (n=9)||4.4|-14.4|0.213
91666587|NCT02420353|183227281|OTHER|mixed effects model||||||0.8573|||||||Mixed Models Analysis|||||||0.8573
91666588|NCT02420353|183227282|OTHER|mixed effects model||||||0.0564|||||||Mixed Models Analysis|||||||0.0564
91666589|NCT02420353|183227283|OTHER|mixed effects model||||||0.7883|||||||Mixed Models Analysis|||||||0.7883
91666590|NCT02420353|183227284|OTHER|mixed effects model||||||0.0901|||||||Mixed Models Analysis|||||||0.0901
91666591|NCT02420353|183227285|OTHER|mixed effects model||||||0.6292|||||||Mixed Models Analysis|||||||0.6292
91666592|NCT02420353|183227286|OTHER|mixed effects model||||||0.161|||||||Mixed Models Analysis|||||||0.161
91666593|NCT02420353|183227287|OTHER|mixed effects model||||||0.4437|||||||Mixed Models Analysis|||||||0.4437
91666594|NCT02420353|183227288|OTHER|mixed effects model||||||0.7325|||||||Mixed Models Analysis|||||||0.7325
91484191|NCT04105543|182841977|OTHER|nonparametric rank test|Median Difference (Final Values)|-6.667||||0.686|TWO_SIDED|95.0|-17.8|20.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Functional Scores Baseline to 6 months (n=5)||20|-17.8|0.686
91484192|NCT04105543|182841977|OTHER|nonparametric rank test|Median Difference (Final Values)|3.846||||0.498|TWO_SIDED|95.0|-0.769|12.82|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Symptom Score Baseline to 3 months (n=9)||12.82|-0.769|0.498
91632471|NCT04806165|183157696|SUPERIORITY|Gender, age, and race were included as auxiliary variables to improve imputation quality. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. For sensitivity analysis, models were run again using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.53||||0.25|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|||Analyses were conducted to determine the effects of each of the four chatbot components on secondary outcomes. This analysis in particular explores the effects of the motivational interviewing component (MI) on participant willingness to seek psychotherapy for concerns their disordered weight and shape behaviors and thoughts since engagement with the intervention. Linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||||0.25
91632472|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.36||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the psychoeducation component (PE) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
91666595|NCT02420353|183227289|OTHER|Mixed effects analysis||||||0.6291|||||||Mixed Models Analysis|||||||0.6291
91666596|NCT02420353|183227290|OTHER|Mixed-effects model||||||0.3332|||||||Mixed Models Analysis|||||||0.3332
91666597|NCT02420353|183227291|OTHER|Mixed effects analysis||||||0.79|||||||Mixed Models Analysis|||||||0.79
91666598|NCT02420353|183227292|OTHER|Mixed effects analysis||||||0.4965|||||||Mixed Models Analysis|||||||0.4965
91666599|NCT02420353|183227293|OTHER|mixed effects analysis||||||0.1331|||||||Mixed Models Analysis|||||||0.1331
91666600|NCT02420353|183227294|OTHER|Mixed-model analysis||||||0.5251|||||||Mixed Models Analysis|||||||0.5251
91666601|NCT02420353|183227295|OTHER|Mixed effects analysis||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
91666602|NCT02420353|183227296|OTHER|Mixed effects analysis||||||0.4852|||||||Mixed Models Analysis|||||||0.4852
91666603|NCT02420353|183227297|OTHER|||||||0.7943|||||||Mixed Models Analysis|||||||0.7943
91666604|NCT02420353|183227298|OTHER|||||||0.0894|||||||Mixed Models Analysis|||||||0.0894
91484193|NCT04105543|182841977|OTHER|nonparametric rank test|Median Difference (Final Values)|10.256||||0.416|TWO_SIDED|95.0|-15.39|35.89|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Symptom Scores Baseline to 6 months (n=5)||35.89|-15.39|0.416
91484194|NCT04105543|182841977|OTHER|nonparametric rank test|Median Difference (Final Values)|-8.33||||0.778|TWO_SIDED|95.0|-20.84|16.67|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Global Health Status Score Baseline to 3 months (n=9)||16.67|-20.84|0.778
91484195|NCT04105543|182841977|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-25.0|25.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Global Health Status Scores Baseline to 6 months (n=5)||25|-25|0.89
91484196|NCT04105543|182841978|OTHER|nonparametric rank test|Median Difference (Final Values)|3.5||||0.138|TWO_SIDED|95.0|-2.0|9.5|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for XeQOL Baseline to 3 months (n=9)||9.5|-2|0.138
91484197|NCT04105543|182841978|OTHER|nonparametric rank test|Median Difference (Final Values)|6.0||||0.225|TWO_SIDED|95.0|-10.0|16.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for XeQOL Baseline to 6 months (n=5)||16|-10|0.225
91666605|NCT02420353|183227299|OTHER|Mixed effects analysis||||||0.0673|||||||Mixed Models Analysis|||||||0.0673
91666606|NCT02420353|183227300|OTHER|Mixed effects analysis||||||0.0185|||||||Mixed Models Analysis|||||||0.0185
91666607|NCT02420353|183227301|OTHER|mixed effects analysis||||||0.6094|||||||Mixed Models Analysis|||||||0.6094
91666608|NCT02420353|183227302|OTHER|mixed effects analysis||||||0.3279|||||||Mixed Models Analysis|||||||0.3279
91666609|NCT02420353|183227303|OTHER|mixed effects analysis||||||0.2802|||||||Mixed Models Analysis|||||||0.2802
91666610|NCT02420353|183227304|OTHER|||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
91666611|NCT02420353|183227305|OTHER|mixed effects model||||||0.0509|||||||Mixed Models Analysis|||||||0.0509
91666612|NCT02420353|183227306|OTHER|mixed effects analysis||||||0.1605|||||||Mixed Models Analysis|||||||0.1605
91666613|NCT02420353|183227307|OTHER|mixed effects model||||||0.0357|||||||Mixed Models Analysis|||||||0.0357
91666614|NCT02420353|183227308|OTHER|mixed effects model||||||0.0122|||||||Mixed Models Analysis|||||||0.0122
91666615|NCT02420353|183227309|OTHER|mixed effects model||||||0.5853|||||||Mixed Models Analysis|||||||0.5853
91666616|NCT02420353|183227310|OTHER|mixed effects model||||||0.6288|||||||Mixed Models Analysis|||||||0.6288
91666617|NCT02420353|183227311|OTHER|mixed effects model||||||0.5022|||||||Mixed Models Analysis|||||||0.5022
91666618|NCT02420353|183227312|OTHER|mixed effects model||||||0.7507|||||||Mixed Models Analysis|||||||0.7507
91666619|NCT02420353|183227313|OTHER|mixed effects model|||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91666620|NCT02420353|183227314|OTHER|mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
91666621|NCT02420353|183227315|OTHER|mixed effects model||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
91632473|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.25||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the personalized recommendation component (PR) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
91714329|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|8.0||0.8269||95.0|-17.5|14.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.0|-17.5|0.8269
91484198|NCT04105543|182841979|OTHER|nonparametric rank test|Median Difference (Final Values)|0.5||||0.674|TWO_SIDED|95.0|-3.0|5.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for Xerostomia Inventory Baseline to 3 months (n=9)||5|-3|0.674
91525791|NCT03587142|182927105|SUPERIORITY||Mean Difference (Net)|1.86||||0.02|TWO_SIDED|95.0|0.33|3.38||P value is nominal: no adjustments made for multiple comparisons. Bonferroni P-value threshold for the level of significance is \<=0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS depression score.||3.38|0.33|0.02
91666622|NCT02420353|183227316|OTHER|Mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
91666623|NCT01149057|183227322|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
91666624|NCT01149057|183227323|SUPERIORITY_OR_OTHER|||||||0.3778|TWO_SIDED|||||P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of L1-L4 T-scores||||0.3778
91666625|NCT01149057|183227323|SUPERIORITY_OR_OTHER|||||||0.1541|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total spine T-score||||0.1541
91666626|NCT01149057|183227323|SUPERIORITY_OR_OTHER|||||||0.789|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total hip - left T-score||||0.7890
91666627|NCT01149057|183227323|SUPERIORITY_OR_OTHER|||||||0.7094|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Femoral neck - left T-scores.||||0.7094
91666628|NCT01149057|183227329|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
91666629|NCT01149057|183227329|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
91666630|NCT01149057|183227329|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
91525792|NCT03587142|182927106|SUPERIORITY||Mean Difference (Net)|0.76||||0.4|TWO_SIDED|95.0|-1.02|2.54||P values are nominal; no adjustments for multiple comparisons|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS anxiety total score. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test||2.54|-1.02|0.40
91666631|NCT01149057|183227329|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
91666632|NCT01149057|183227330|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
91666633|NCT01149057|183227331|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
91666634|NCT01149057|183227332|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
91666635|NCT01149057|183227333|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
91666636|NCT01149057|183227334|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
91484199|NCT04105543|182841979|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.892|TWO_SIDED|95.0|-6.0|6.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Xerostomia Inventory Baseline to 6 months (n=5)||6|-6|0.892
91666637|NCT01149057|183227335|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
91666638|NCT01149057|183227336|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
91666639|NCT01149057|183227337|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
91666640|NCT01149057|183227337|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
91666641|NCT01149057|183227337|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
91666642|NCT01149057|183227337|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
91666643|NCT03790137|183227363|OTHER|The frequency of HWE for each patient was reported as episodes/day, as determined by dividing the total number of seizures experienced over a given time period by the number of days for which seizures were recorded. Paired t-tests were performed to compare each patient's baseline seizure frequency to their seizure frequency in the last month of treatment. Change in seizure frequency is reported as percent change from baseline. An alpha of 0.05 was used for statistical significance.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91666644|NCT03921554|183227392|SUPERIORITY||Estimated change (52 weeks - baseline)|0.9|||<|0.0005|TWO_SIDED|95.0|0.5|1.2||The a priori threshold for statistical significance was \< 0.05.|Wald test||We fit a GEE model with AGS score as outcome and an indicator variable for 52 weeks. An exchangeable correlation structure was used to model intra-participant association of AGS scores. The model allowed for up to 2 measurements per participant.|"We are testing the null hypothesis is that the change from baseline (52 weeks - baseline) in AGS is zero.~45 participants had 2 measurements (at baseline and 52 weeks); 6 participants had 1 measurement (at baseline). All participants were included in the analysis."||1.2|0.5|<0.0005
91484200|NCT00471146|182841986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.5436|TWO_SIDED|95.0|0.786|1.309||One-sided log-rank test at alpha = 0.025 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.309|0.786|0.5436
91484201|NCT00471146|182841987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.5203|TWO_SIDED|95.0|0.779|1.298||One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.298|0.779|0.5203
91484202|NCT00471146|182841988|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.2||||0.038|TWO_SIDED|95.0|1.0|10.1|||Cochran-Mantel-Haenszel|||Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||10.1|1.0|0.038
91666645|NCT03921554|183227393|SUPERIORITY||Estimated change (Day 673 - Day 0)|1.09|||<|0.0005|TWO_SIDED|95.0|0.57|1.62||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of AGS on day of treatment (modeled with cubic splines with knots at days 0, 84, 168, 336, 506, 673, and 1006). Goodness of fit criteria were used to select GEE model with AR(1) correlation structure.|We estimate change from Day 0 to Day 673 of treatment (Day 673 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||1.62|0.57|<0.0005
91666646|NCT03921554|183227394|SUPERIORITY||Estimated change (52 weeks - baseline)|2.2||||0.295|TWO_SIDED|95.0|-1.9|6.4||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.4|-1.9|0.295
91666647|NCT03921554|183227394|SUPERIORITY||Estimated change (52 weeks - baseline)|7.0||||0.007|TWO_SIDED|95.0|1.9|12.0||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||12.0|1.9|0.007
91714330|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.34||0.3319||95.0|-24.5|8.3|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.3|-24.5|0.3319
91484203|NCT02001181|182842014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.8|STANDARD_ERROR_OF_MEAN|8.48|<|0.0001|TWO_SIDED|80.0|-62.8|-40.8|||Mixed Models Analysis|The mixed model for repeated measures analysis included all the participants in FAS.||||-40.8|-62.8|<0.0001
91484204|NCT02520661|182842021|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.62|1.22||||||treatment relevant change in number of ED visits by 14 days||1.22|0.62|
91484205|NCT02520661|182842021|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.3||||||treatment relevant change in number of ED visits by 30 days||1.30|0.72|
91484206|NCT02301988|182842050|SUPERIORITY||Difference in Response Rates|3.77||||0.519||95.0|-8.99|16.54|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||16.54|-8.99|0.519
91484207|NCT02301988|182842051|SUPERIORITY||Difference in response rates|3.29||||0.7817|TWO_SIDED|95.0|-25.52|32.1|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||32.10|-25.52|0.7817
91484208|NCT02301988|182842052|SUPERIORITY||Difference in Response Rates|7.7||||0.2234|TWO_SIDED|95.0|-5.95|21.35|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||21.35|-5.95|0.2234
91484209|NCT02301988|182842053|SUPERIORITY||Difference in response rates|-2.96||||0.8169|TWO_SIDED|95.0|-33.91|27.99|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.99|-33.91|0.8169
91484210|NCT02301988|182842054|SUPERIORITY||Difference in response rate|11.11||||0.1607||95.0|-5.64|27.85|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.85|-5.64|0.1607
91484211|NCT02301988|182842055|SUPERIORITY||Difference in Response Rates|23.68||||0.1486|TWO_SIDED|95.0|-13.57|60.94|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||60.94|-13.57|0.1486
91484212|NCT02301988|182842056|SUPERIORITY||Difference in Response Rates|6.09||||0.498|TWO_SIDED|95.0|-15.01|27.2|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||27.20|-15.01|0.4980
91484213|NCT02301988|182842057|SUPERIORITY||Difference in Response Rates|9.66||||0.3032||95.0|-12.25|31.58|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||31.58|-12.25|0.3032
91525793|NCT03587142|182927107|SUPERIORITY||Mean Difference (Net)|-0.21||||0.25|TWO_SIDED|95.0|-0.57|0.15||P value is nominal with no adjustment for multiple comparisons. The Bonferroni level of significance threshold is \<=0.002.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of PAGI-QOL total score.||0.15|-0.57|0.25
91632474|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.29||||0.53|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the repeated administration component (RA) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.53
91632475|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.53||||0.07|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.07
91632476|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-1.06||||0.01|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.01
91632477|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.85||||0.042|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.042
91666648|NCT03921554|183227394|SUPERIORITY||Estimated change (52 weeks - baseline)|0.26||||0.932|TWO_SIDED|95.0|-5.7|6.2||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.2|-5.7|0.932
91666649|NCT03921554|183227395|SUPERIORITY||Estimated change (Day 3 - Day 0)|-8.76|||<|0.0005|TWO_SIDED|95.0|-11.7|-5.81||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a QLS model of ISG on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select QLS model with exchangeable correlation structure.|We estimate change from pre to post treatment (Day 3 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-5.81|-11.7|<0.0005
91666650|NCT03921554|183227396|SUPERIORITY||Estimated change (day 335 minus day 0)|-0.11||||0.002|TWO_SIDED|95.0|-0.18|-0.04||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of diary average score on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select GEE model with exchangeable correlation structure.|We estimate change from Day 0 to Day 335 (Day 335 - Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-0.04|-0.18|0.002
91666651|NCT02005562|183227464|SUPERIORITY_OR_OTHER|||||||0.479|||||||Chi-squared|||||||0.479
91666652|NCT02005562|183227465|SUPERIORITY_OR_OTHER|||||||0.6736|||||||ANOVA|||||||0.6736
91666653|NCT02005562|183227466|SUPERIORITY_OR_OTHER|||||||0.2172|||||||ANOVA|||||||0.2172
91666654|NCT02005562|183227467|SUPERIORITY_OR_OTHER|||||||0.477|||||||ANOVA|||||||0.4770
91666655|NCT02005562|183227469|SUPERIORITY_OR_OTHER|||||||0.0764|||||||Log Rank|||||||0.0764
91484214|NCT02301988|182842059|SUPERIORITY||Difference in Response Rates|4.2||||0.628|TWO_SIDED|95.0|-14.37|22.76|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||22.76|-14.37|0.6280
91632478|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.08||||0.89|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.89
91632479|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.34||||0.69|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.69
91525794|NCT03587142|182927108|SUPERIORITY||Mean Difference (Net)|-1.98||||0.36|TWO_SIDED|95.0|-6.2|2.24|||ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. P (2-sided) were determined from a Wald-Chi-Square test.||2.24|-6.20|0.36
91632480|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.69||||0.4|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.40
91632481|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.35||||0.55|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.55
91666656|NCT02005562|183227470|SUPERIORITY_OR_OTHER|||||||0.418|||||||Fisher Exact|||Week 12||||0.418
91666657|NCT02005562|183227470|SUPERIORITY_OR_OTHER|||||||0.841|||||||Fisher Exact|||Week 52||||0.841
91666658|NCT02005562|183227471|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Week 12||||0.245
91666659|NCT02005562|183227471|SUPERIORITY_OR_OTHER|||||||0.637|||||||Fisher Exact|||Week 52||||0.637
91666660|NCT02005562|183227472|SUPERIORITY_OR_OTHER|||||||0.512||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 12.|Fisher Exact|||||||0.512
91666661|NCT02005562|183227472|SUPERIORITY_OR_OTHER|||||||0.718||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 52.|Fisher Exact|||||||0.718
91666662|NCT02005562|183227474|SUPERIORITY_OR_OTHER|||||||0.86|||||||Log Rank|||||||0.860
91484215|NCT02301988|182842060|SUPERIORITY||Difference in Response Rates|8.33||||0.6291|TWO_SIDED|95.0|-33.04|49.71|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||49.71|-33.04|0.6291
91525795|NCT03587142|182927109|SUPERIORITY||Mean Difference (Net)|-2.07||||0.15|TWO_SIDED|95.0|-4.91|0.76||P value is nominal; no adjustments made for multiple comparisons Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.76|-4.91|0.15
91484216|NCT01535664|182842072|SUPERIORITY_OR_OTHER||Difference in least square means|4.04|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED|95.0|0.87|7.2||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment.||The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall gait was the average of WA, TW, and SQT; a higher score is indicative of better performance.||7.20|0.87|0.015
91632482|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.88||||0.32|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.32
91632483|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.37||||0.63|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.63
91632484|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.08||||0.9|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.90
91666663|NCT01863186|183227517|SUPERIORITY|||||||0.0166|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0166
91666664|NCT01863186|183227517|SUPERIORITY|||||||0.0033|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0033
91666665|NCT04402489|183227550|SUPERIORITY||Least Square Mean Difference vs Placebo|9.8|STANDARD_ERROR_OF_MEAN|14.35||0.496|TWO_SIDED|95.0|-18.52|38.12|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - lower dose||38.12|-18.52|0.496
91666666|NCT04402489|183227550|SUPERIORITY||Least Square Mean Difference vs Placebo|22.7|STANDARD_ERROR_OF_MEAN|14.38||0.116|TWO_SIDED|95.0|-5.68|51.09|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - higher dose||51.09|-5.68|0.116
91666667|NCT04402489|183227551|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.23|-0.44|||Mixed-effect model for repeated measures|||||-0.44|-1.23|< 0.001
91666668|NCT04402489|183227551|SUPERIORITY||Least Square Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.83|-1.03|||Mixed-effect model for repeated measures|||||-1.03|-1.83|< 0.001
91714331|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|8.09||0.7552||95.0|-13.4|18.5|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-13.4|0.7552
91484217|NCT01535664|182842073|SUPERIORITY_OR_OTHER||Difference in least square means|1.7|STANDARD_ERROR_OF_MEAN|0.5||0.003|TWO_SIDED|95.0|0.7|2.8|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||2.8|0.7|0.003
91714332|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|8.16||0.0137||95.0|-36.3|-4.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-4.2|-36.3|0.0137
91714333|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.0|STANDARD_ERROR_OF_MEAN|8.22||0.1157||95.0|-29.2|3.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.2|-29.2|0.1157
91714334|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.04||0.3791||95.0|-22.9|8.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.7|-22.9|0.3791
91714335|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|8.39||0.1329||95.0|-29.2|3.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.9|-29.2|0.1329
91714336|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|8.09||0.7723||95.0|-13.6|18.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.3|-13.6|0.7723
91714337|NCT00676403|183320242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.5|STANDARD_ERROR_OF_MEAN|8.16||0.0063||95.0|-38.6|-6.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.4|-38.6|0.0063
91714338|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.254||0.1715||95.0|-0.15|0.85|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.85|-0.15|0.1715
91714339|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.251||0.7944||95.0|-0.43|0.56|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.43|0.7944
91714340|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.255||0.1994||95.0|-0.17|0.83|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.83|-0.17|0.1994
91714341|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.251||0.3652||95.0|-0.27|0.72|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.72|-0.27|0.3652
91714342|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.251||0.0481||95.0|0.0|0.99|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.99|0.00|0.0481
91714343|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.256||0.2501||95.0|-0.21|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.80|-0.21|0.2501
91484218|NCT01535664|182842074|SUPERIORITY_OR_OTHER||Difference in least square means|7.729|STANDARD_ERROR_OF_MEAN|2.495||0.006|TWO_SIDED|95.0|2.507|12.95|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||12.950|2.507|0.006
91484219|NCT01535664|182842075|SUPERIORITY_OR_OTHER||Difference in least square means|0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.19|0.54|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||0.54|0.19|<.001
91527829|NCT06173570|182930687|SUPERIORITY||Mean Difference (Net)|-33.39|||<|0.001|TWO_SIDED|95.0|-41.71|-25.08|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-25.08|-41.71|< 0.001
91484220|NCT01535664|182842076|SUPERIORITY_OR_OTHER||Difference in least square means|-2.38|STANDARD_ERROR_OF_MEAN|2.97||0.434|TWO_SIDED|95.0|-8.6|3.84||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance was a weighted average of SOT, LOS, and ADT.||3.84|-8.60|0.434
91484221|NCT01857583|182842090|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.6|||||TWO_SIDED|95.0|-10.0|33.6|||ANCOVA|||||33.6|-10.0|
91484222|NCT01857583|182842090|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|17.3|||||TWO_SIDED|95.0|-10.2|42.1|||ANCOVA|||||42.1|-10.2|
91484223|NCT00859027|182842096|OTHER|||||||0.004|||||||One way ANOVA|||Percent change in femoral neck BMD from baseline||||0.004
91484224|NCT00859027|182842096|OTHER|||||||0.001|||||||One way ANOVA|||Percent change in total hip BMD from baseline||||0.001
91484225|NCT00859027|182842096|OTHER|||||||0.04|||||||One way ANOVA|||Percent change in lumbar spine BMD from baseline||||0.04
91484226|NCT00859027|182842096|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for the femoral neck BMD||||<0.01
91484227|NCT00859027|182842096|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for total hip BMD||||<0.01
91484228|NCT00859027|182842097|OTHER|||||||0.015|||||||ANOVA|||Between group difference of percent change for NTX||||0.015
91632485|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.95||||0.27|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.27
91484229|NCT00859027|182842097|OTHER|||||||0.01|||||||ANOVA|||Between group difference of percent change for CTX||||0.01
91484230|NCT02775903|182842105|SUPERIORITY|||||||0.1838|||||||Wald asymptotic two-sided test|||||||0.1838
91484231|NCT02775903|182842106|SUPERIORITY|||||||0.618|||||||Wald asymptotic two-sided test|||||||0.6180
91484232|NCT02775903|182842107|OTHER|P-values were not part of the formal testing.||||||0.7016|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)||||||0.7016
91525796|NCT03587142|182927110|SUPERIORITY||Mean Difference (Net)|1.37||||0.76|TWO_SIDED|95.0|-7.51|10.25||P value is nominal: no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported. P (2-sided) determined from a Wald Chi-Square test.||10.25|-7.51|0.76
91484233|NCT02775903|182842108|OTHER|P-values were not part of the formal testing.||||||0.6076|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.6076
91484234|NCT02775903|182842109|OTHER|P-values were not part of the formal testing.||||||0.384|||||||Wald asymptotic two-sided test|||||||0.3840
91484235|NCT02775903|182842110|OTHER|P-values were not part of the formal testing.||||||0.8961|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8961
91484236|NCT02775903|182842111|OTHER|P-values were not part of the formal testing.||||||0.3591|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.3591
91484237|NCT02775903|182842112|OTHER|P-values were not part of the formal testing.||||||0.9031|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.9031
91484238|NCT02775903|182842114|OTHER|P-values were not part of the formal testing.||||||0.2409|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).||||||0.2409
91484239|NCT02775903|182842115|OTHER|P-values were not part of the formal testing.||||||0.0688|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0688
91484240|NCT02775903|182842116|OTHER|P-values were not part of the formal testing.||||||0.4894|||||||Wald asymptotic two-sided test|||||||0.4894
91484241|NCT02775903|182842118|OTHER|P-values were not part of the formal testing.||||||0.0381|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0381
91484242|NCT02775903|182842120|OTHER|P-values were not part of the formal testing.||||||0.8973|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8973
91484243|NCT02775903|182842120|OTHER|P-values were not part of the formal testing.||||||0.0691|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0691
91484244|NCT03552965|182842152|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12"|||
91484245|NCT03552965|182842153|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.894, Range=2, 25th percentile=1, Median=2, 75th percentile=3, n=6 Robust: Mean=2.91, SD=1.136, Range=3, 25th percentile=2, Median=3, 75th percentile=4, n=11"|||
91484246|NCT03552965|182842154|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2.5, SD=0.577, Range=1, 25th percentile=2, Median=2.5, 75th percentile=3, n=4 Robust: Mean=2.33, SD=1.225, Range=3, 25th percentile=1, Median=2, 75th percentile=3.5, n=9"|||
91484247|NCT03552965|182842155|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.83, SD=0.753, Range=2, 25th percentile=1, Median=2, 75th percentile=2.25, n=6 Robust: Mean=2.33, SD=1, Range=3, 25th percentile=1.5, Median=2, 75th percentile=3, n=9"|||
91484248|NCT03552965|182842156|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.707, Range=2, 25th percentile=1.5, Median=2, 75th percentile=2.5, n=5 Robust: Mean=2.38, SD=1.188, Range=3, 25th percentile=1.25, Median=2, 75th percentile=3.75, n=8"|||
91484249|NCT03552965|182842157|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=15.5, SD=23.76242, Range=75, 25th percentile=0, Median=5, 75th percentile=21.25, n=10 Robust: Mean=14.1346, SD=17.87095, Range=52.5, 25th percentile=0, Median=6.25, 75th percentile=27.5, n=13"|||
91484250|NCT03552965|182842158|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=45.625, SD=30.68744, Range=71.25, 25th percentile=11.25, Median=58.125, 75th percentile=71.25, n=6 Robust: Mean=64.3182, SD=15.0142, Range=48.75, 25th percentile=66.25, Median=70, 75th percentile=71.25, n=11"|||
91484251|NCT03552965|182842159|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=60, SD=23.68412, Range=60, 25th percentile=38.125, Median=68.75, 75th percentile=77.5, n=5 Robust: Mean=54.8611, SD=29.91815, Range=80, 25th percentile=24.375, Median=66.25, 75th percentile=80, n=9"|||
91484252|NCT03552965|182842160|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=31.67, SD=31.38139, Range=85, 25th percentile=5.625, Median=25, 75th percentile=56.875, n=6 Robust: Mean=54.0278, SD=24.57274, Range=67.5, 25th percentile=33.75, Median=62.5, 75th percentile=72.5, n=9"|||
91632486|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.67||||0.42|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.42
91484253|NCT03552965|182842161|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=50.75, SD=30.29284, Range=72.5, 25th percentile=21.875, Median=48.75, 75th percentile=80.625, n=5 Robust: Mean=38.4375, SD=26.69897, Range=66.25, 25th percentile=15, Median=29.375, 75th percentile=68.75, n=8"|||
91484254|NCT05108922|182842162|SUPERIORITY||Odds Ratio (OR)|29.26|||<|0.001|TWO_SIDED|95.0|5.3|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, Apolipoprotein (ApoE) ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|5.30|<0.001
91484255|NCT05108922|182842163|SUPERIORITY||Odds Ratio (OR)|15.18||||0.008|TWO_SIDED|95.0|2.04|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, ApoE ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|2.04|0.008
91484256|NCT05108922|182842164|SUPERIORITY||LS Mean difference (Final Values)|-45.691|STANDARD_ERROR_OF_MEAN|4.6132|<|0.001|TWO_SIDED|95.0|-54.84|-36.54||Analysis between treatment group comparison p-value using analysis of covariance (ANCOVA) model for endpoint measures: Change (CHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-36.54|-54.84|<0.001
91484257|NCT05108922|182842165|SUPERIORITY||LS Mean difference (Final Values)|-48.213|STANDARD_ERROR_OF_MEAN|4.9276|<|0.001|TWO_SIDED|95.0|-57.99|-38.44||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: Percent change (PCHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-38.44|-57.99|<0.001
91484258|NCT05108922|182842166|SUPERIORITY||LS Mean difference (Final Values)|-40.252|STANDARD_ERROR_OF_MEAN|10.551|<|0.001|TWO_SIDED|95.0|-61.87|-18.64||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: CHG = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-18.64|-61.87|<0.001
91484259|NCT05108922|182842167|SUPERIORITY||LS Mean difference (Final Values)|-23.97|STANDARD_ERROR_OF_MEAN|4.231|<|0.001|TWO_SIDED|95.0|-32.35|-15.6||Analysis between treatment group comparison p-value using mixed model for repeated measures (MMRM) model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-15.60|-32.35|<0.001
91484260|NCT05108922|182842168|SUPERIORITY||LS Mean difference (Final Values)|-25.82|STANDARD_ERROR_OF_MEAN|4.381|<|0.001|TWO_SIDED|95.0|-34.49|-17.15||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-17.15|-34.49|<0.001
91484261|NCT05108922|182842169|SUPERIORITY||Odds Ratio (OR)|8.38|||<|0.001|TWO_SIDED|95.0|3.37|20.81||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured|Regression, Logistic|||||20.81|3.37|<0.001
91484262|NCT05108922|182842170|SUPERIORITY||Odds Ratio (OR)|37.73|||<|0.001|TWO_SIDED|95.0|5.71|99.99||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Regression, Logistic|||||99.99|5.71|<.001
91484263|NCT05108922|182842171|SUPERIORITY||LS Mean difference (Final Values)|-26.75|STANDARD_ERROR_OF_MEAN|6.479|<|0.001|TWO_SIDED|95.0|-39.78|-13.73||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-13.73|-39.78|<0.001
91632487|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.23||||0.04|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.04
91484264|NCT05108922|182842172|SUPERIORITY||LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187||0.0558|TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|0.0558
91632488|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.22||||0.16|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Multilevel Models|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.16
91632489|NCT04806165|183157696|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.01||||0.99|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.99
91666669|NCT04402489|183227552|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.76||||0.199|TWO_SIDED|95.0|0.49|1.16|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||1.16|0.49|0.199
91666670|NCT04402489|183227552|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.55||||0.006|TWO_SIDED|95.0|0.36|0.84|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||0.84|0.36|0.006
91666671|NCT04402489|183227553|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.55|TWO_SIDED|95.0|-0.62|0.33|||mixed-effect model for repeated measures|||||0.33|-0.62|0.55
91666672|NCT04402489|183227553|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.343|TWO_SIDED|95.0|-0.72|0.25|||mixed-effect model for repeated measures|||||0.25|-0.72|0.343
91666673|NCT04402489|183227554|SUPERIORITY||Odds Ratio (OR)|0.805||||0.642|TWO_SIDED|95.0|0.323|2.007|||Regression, Logistic|||||2.007|0.323|0.642
91666674|NCT04402489|183227554|SUPERIORITY||Odds Ratio (OR)|1.412||||0.431|TWO_SIDED|95.0|0.598|3.336|||Regression, Logistic|||||3.336|0.598|0.431
91666675|NCT04402489|183227555|SUPERIORITY||Least Square Mean Difference vs Placebo|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.072|TWO_SIDED|95.0|-0.08|1.82|||mixed-effect model for repeated measures|||||1.82|-0.08|0.072
91666676|NCT04402489|183227555|SUPERIORITY||Least Square Mean Difference vs Placebo|0.56|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|95.0|-0.4|1.51|||mixed-effect model for repeated measures|||||1.51|-0.4|0.252
91666677|NCT05223868|183227561|SUPERIORITY||||||=|0.002||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose versus (vs) placebo were not.|Cochran-Mantel-Haenszel|||||||=0.002
91666678|NCT05223868|183227561|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91484265|NCT05108922|182842173|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids|LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187|||TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|
91666679|NCT05223868|183227561|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666680|NCT05223868|183227561|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666681|NCT05223868|183227561|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666682|NCT05223868|183227562|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666683|NCT05223868|183227562|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666684|NCT05223868|183227562|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666685|NCT05223868|183227562|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91525797|NCT03587142|182927111|SUPERIORITY||Mean Difference (Net)|-0.05||||0.1|TWO_SIDED|95.0|-0.12|0.01||Nominal P values; no adjustment for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) were computed using ANCOVA, regressing change in IMD from baseline to 4-weeks on treatment group and the baseline value of IMD. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.01|-0.12|0.10
91666686|NCT05223868|183227562|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666687|NCT05223868|183227563|SUPERIORITY||||||=|0.002||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.002
91666688|NCT05223868|183227563|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666689|NCT05223868|183227563|SUPERIORITY||||||=|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.001
91525798|NCT03587142|182927112|SUPERIORITY||Mean Difference (Net)|-21.51||||0.29|TWO_SIDED|95.0|-99.4|56.4||Nominal P values; no adjustments for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of teh outcome. Wald 95% Confidence Limits are reported; P (2-sided) determined from a Wald Chi-Square test.||56.4|-99.4|0.29
91666690|NCT05223868|183227563|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666691|NCT05223868|183227563|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666692|NCT05223868|183227564|SUPERIORITY||||||=|0.021||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.021
91666693|NCT05223868|183227564|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666694|NCT05223868|183227564|SUPERIORITY||||||=|0.038||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.038
91666695|NCT05223868|183227564|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666696|NCT05223868|183227564|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666697|NCT05223868|183227565|SUPERIORITY||||||=|0.003||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.003
91666698|NCT05223868|183227565|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666699|NCT05223868|183227565|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666700|NCT05223868|183227565|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666701|NCT05223868|183227565|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666702|NCT05223868|183227566|SUPERIORITY||||||=|0.006||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.006
91666703|NCT05223868|183227566|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666704|NCT05223868|183227566|SUPERIORITY||||||=|0.009||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.009
91666705|NCT05223868|183227566|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666706|NCT05223868|183227566|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666707|NCT05223868|183227567|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666708|NCT05223868|183227567|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666709|NCT05223868|183227567|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666710|NCT05223868|183227567|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666711|NCT05223868|183227567|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91484266|NCT05108922|182842174|SUPERIORITY||LS Mean difference (Final Values)|-12.04|STANDARD_ERROR_OF_MEAN|4.12||0.004|TWO_SIDED|95.0|-20.19|-3.88||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-3.88|-20.19|0.004
91525799|NCT03587142|182927113|SUPERIORITY||Mean Difference (Net)|0.09||||0.84|TWO_SIDED|95.0|-0.78|0.95||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to week 4 on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported: P (2-sided) determined from Wald Chi-Square test.||0.95|-0.78|0.84
91632490|NCT04806165|183157697|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the time effect of attitudinal changes over the 14 week course of the study, regardless of the combination of components participants were assigned (ie., component turned off or on). Results will help determine whether mean participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns varied based on the time elapsed since engagement with the intervention (ie., do attitudinal changes post-inntervention endure over time?).||||<.001
91632491|NCT04806165|183157697|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.026|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the motivational interviewing (MI) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.026
91632492|NCT04806165|183157697|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.465|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the personalized recommendation (PR) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.465
91666712|NCT05223868|183227568|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666713|NCT05223868|183227568|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666714|NCT05223868|183227568|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666715|NCT05223868|183227568|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666716|NCT05223868|183227568|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666717|NCT05223868|183227569|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666718|NCT05223868|183227569|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666719|NCT05223868|183227569|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666720|NCT05223868|183227569|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91666721|NCT05223868|183227569|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||||||<0.001
91484267|NCT05108922|182842175|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91484268|NCT05108922|182842176|SUPERIORITY||LS Mean difference (Final Values)|-13.45|STANDARD_ERROR_OF_MEAN|4.3||0.002|TWO_SIDED|95.0|-21.96|-4.93||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-4.93|-21.96|0.002
91484269|NCT05108922|182842177|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.001|TWO_SIDED|95.0|1.93|11.34||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||11.34|1.93|<0.001
91632493|NCT04806165|183157697|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.536|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the psychoeducation (PE) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.536
91632494|NCT04806165|183157697|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.049|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the repeated administration (RA) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.049
91632495|NCT02059174|183157703|NON_INFERIORITY_OR_EQUIVALENCE|A frailty model was used with effects for treatment, period and sequence and a random effect for participant. A value of 1.00 for the hazard ratio corresponds to no difference between treatments.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.59|||||ratio (MK-1293 / EU-Approved Lantus)|Because numerous participants did not achieve End of Action within the 30-hour clamp timeframe, the pre-specified hypothesis of similarity with regard to mean DOA could not be tested and a survival analysis approach was undertaken. The hazard rate is a measure of the instantaneous risk of reaching End of Action at time t given End of Action has not been met up until time t, with the hazard ratio being an estimate of the relative difference in hazard rates between treatments.||1.59|0.72|
91632496|NCT02059174|183157704|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.95|||||TWO_SIDED|95.0|0.88|1.01|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.01|0.88|
91632497|NCT02059174|183157705|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.9|||||TWO_SIDED|95.0|0.81|0.99|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.99|0.81|
91525800|NCT03587142|182927114|SUPERIORITY||Mean Difference (Net)|-6.43||||0.27|TWO_SIDED|95.0|-17.9|5.03||P value is nominal|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||5.03|-17.90|0.27
91632498|NCT02059174|183157706|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.06|0.92|
91632499|NCT02059174|183157707|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.96|||||TWO_SIDED|95.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
91632500|NCT02059174|183157708|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
91632501|NCT02059174|183157709|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.03|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.03|0.93|
91632502|NCT02059174|183157710|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.86|0.97|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.97|0.86|
91666722|NCT05223868|183227570|SUPERIORITY||||||=|0.006||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.006
91666723|NCT05223868|183227570|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666724|NCT05223868|183227570|SUPERIORITY||||||=|0.005||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.005
91666725|NCT05223868|183227570|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91484270|NCT05108922|182842178|SUPERIORITY||Odds Ratio (OR)|6.34||||0.022|TWO_SIDED|95.0|1.32|30.54||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||30.54|1.32|0.022
91792448|NCT02047318|183462639|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|0.982||0.5298|TWO_SIDED|95.0|-0.66|0.35||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||0.35|-0.66|0.5298
91632503|NCT02059174|183157711|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|1.0|||||TWO_SIDED|90.0|0.95|1.04|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.04|0.95|
91632504|NCT01196936|183157713|SUPERIORITY|||||||0.05||||||The calculated p-value is 0.05.|Mixed Models Analysis|||||||0.05
91632505|NCT01196936|183157714|SUPERIORITY|||||||0.0266|||||||Mixed Models Analysis|||||||0.0266
91632506|NCT01196936|183157715|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91632507|NCT01196936|183157716|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91632508|NCT01196936|183157717|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91632509|NCT01196936|183157718|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||> 0.05
91632510|NCT01196936|183157719|SUPERIORITY|||||||0.071|||||||Mixed Models Analysis|||||||0.071
91632511|NCT01196936|183157720|SUPERIORITY|||||||0.739|||||||Mixed Models Analysis|||||||0.739
91632512|NCT01196936|183157721|SUPERIORITY|||||||0.8315|||||||Mixed Models Analysis|||||||0.8315
91632513|NCT03229538|183157722|OTHER||Adjusted Odds Ratio|0.86||||0.14|TWO_SIDED|95.0|0.71|1.05|||Regression, Logistic|||||1.05|0.71|0.14
91632514|NCT03229538|183157722|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-2.6|0.9|||||Difference = Methylprednisolone - Placebo|Rank = 97||0.9|-2.6|
91632515|NCT03229538|183157722|OTHER||Percent Difference|-1.5|||||TWO_SIDED|95.0|-3.5|0.5|||||Difference = Methylprednisolone - Placebo|Rank \> or = 96||0.5|-3.5|
91632516|NCT03229538|183157722|OTHER||Percent Difference|-2.2|||||TWO_SIDED|95.0|-4.4|0.1|||||Difference = Methylprednisolone - Placebo|Rank \> or = 95||0.1|-4.4|
91632517|NCT03229538|183157722|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.3|2.7|||||Difference = Methylprednisolone - Placebo|Rank \> or = 94||2.7|-4.3|
91666726|NCT05223868|183227570|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666727|NCT05223868|183227571|SUPERIORITY||||||=|0.317||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.317
91632518|NCT03229538|183157722|OTHER||Percent Difference|-3.8|||||TWO_SIDED|95.0|-7.8|0.2|||||Difference = Methylprednisolone - Placebo|Rank \> or = 93||0.2|-7.8|
91632519|NCT03229538|183157722|OTHER||Percent Difference|-3.4|||||TWO_SIDED|95.0|-7.8|0.9|||||Difference = Methylprednisolone - Placebo|Rank \> or = 92||0.9|-7.8|
91632520|NCT03229538|183157722|OTHER||Percent Difference|-3.1|||||TWO_SIDED|95.0|-7.5|1.3|||||Difference = Methylprednisolone - Placebo|Rank \> or = 91||1.3|-7.5|
91632521|NCT03229538|183157723|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.74||||0.428|TWO_SIDED|95.0|0.34|1.57|||Regression, Logistic|||||1.57|0.34|0.428
91632522|NCT03229538|183157724|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.83||||0.228|TWO_SIDED|95.0|0.61|1.13|||Regression, Logistic|||||1.13|0.61|0.228
91632523|NCT03229538|183157725|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-4.0|0.4||||||||0.4|-4.0|
91632524|NCT03229538|183157726|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.79||||0.309|TWO_SIDED|95.0|0.5|1.25|||Regression, Logistic|||||1.25|0.50|0.309
91632525|NCT03229538|183157727|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.57|||Regression, Logistic|||||1.57|0.52|0.723
91632526|NCT03229538|183157729|SUPERIORITY||Adjusted Odds Ratio|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||Regression, Logistic|||||1.11|0.67|0.256
91632527|NCT02511106|183157735|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.3|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.30|0.18|<0.0001
91632528|NCT02511106|183157736|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.21|0.34|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.34|0.21|<0.0001
91632529|NCT02511106|183157739|SUPERIORITY||Hazard Ratio (HR)|0.4913||||0.0004|TWO_SIDED|95.03|0.3307|0.7299|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7299|0.3307|0.0004
91632530|NCT02511106|183157740|SUPERIORITY||Hazard Ratio (HR)|0.4912|||<|0.0001|TWO_SIDED|95.03|0.3439|0.7017|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7017|0.3439|<0.0001
91632531|NCT02274311|183157768|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Measures of central tendency (mean) and variability (range and/or SD) were used to describe numeric variables. Paired Student's t test was used to verify the mean differences between dependent normally distributed variables. Wilcoxon sign test was performed to non-normally distributed dependent variables.~Asignificance level of 5%was adopted for all statistical tests (P \<.05)."||||< 0.05
91632532|NCT01955005|183157828|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p\<0.001||||<0.001
91632533|NCT01955005|183157829|SUPERIORITY_OR_OTHER||Z score|568.5||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
91632534|NCT01955005|183157830|SUPERIORITY_OR_OTHER||Table Probability|0.0142||||0.02|TWO_SIDED||||||Fisher's Exact|||||||0.02
91666728|NCT05223868|183227571|SUPERIORITY||||||=|0.012||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.012
91666729|NCT05223868|183227571|SUPERIORITY||||||=|0.038||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.038
91632535|NCT01200758|183157838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.|Geometric mean ratio|1.62|||||TWO_SIDED|90.0|1.36|1.94|||||Geometric mean ratio adjusted for tumor load at baseline.|||1.94|1.36|
91666730|NCT05223868|183227571|SUPERIORITY||||||=|0.006||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.006
91666731|NCT05223868|183227571|SUPERIORITY||||||=|0.011||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.011
91666732|NCT05223868|183227572|SUPERIORITY||||||=|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||=0.001
91666733|NCT05223868|183227572|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666734|NCT05223868|183227572|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666735|NCT05223868|183227572|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666736|NCT05223868|183227572|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||||||<0.001
91666737|NCT05223868|183227573|SUPERIORITY||||||=|0.002||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Physical Function||||=0.002
91666738|NCT05223868|183227573|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Physical Function||||<0.001
91666739|NCT05223868|183227573|SUPERIORITY||||||=|0.002||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Physical Function||||=0.002
91666740|NCT05223868|183227573|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Physical Function||||<0.001
91666741|NCT05223868|183227573|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Physical Function||||<0.001
91666742|NCT05223868|183227573|SUPERIORITY||||||=|0.251||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Anxiety||||=0.251
91666743|NCT05223868|183227573|SUPERIORITY||||||=|0.087||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Anxiety||||=0.087
91666744|NCT05223868|183227573|SUPERIORITY||||||=|0.205||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Anxiety||||=0.205
91666745|NCT05223868|183227573|SUPERIORITY||||||=|0.082||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Anxiety||||=0.082
91666746|NCT05223868|183227573|SUPERIORITY||||||=|0.01||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Anxiety||||=0.010
91666747|NCT05223868|183227573|SUPERIORITY||||||=|0.357||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Depression||||=0.357
91666748|NCT05223868|183227573|SUPERIORITY||||||=|0.222||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Depression||||=0.222
91666749|NCT05223868|183227573|SUPERIORITY||||||=|0.987||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Depression||||=0.987
91666750|NCT05223868|183227573|SUPERIORITY||||||=|0.39||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Depression||||=0.390
91666751|NCT05223868|183227573|SUPERIORITY||||||=|0.38||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Depression||||=0.380
91666752|NCT05223868|183227573|SUPERIORITY||||||=|0.349||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Fatigue||||=0.349
91666753|NCT05223868|183227573|SUPERIORITY||||||=|0.553||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Fatigue||||=0.553
91632536|NCT01200758|183157839|SUPERIORITY_OR_OTHER||Difference in response rates|-4.82||||0.2835|TWO_SIDED|95.0|-14.0|4.4|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.4|-14.0|0.2835
91632537|NCT01200758|183157839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.38|1.33||||||||1.33|0.38|
91632538|NCT01200758|183157840|SUPERIORITY_OR_OTHER||Difference in response rates|7.66||||0.2047|TWO_SIDED|95.0|-5.0|20.3|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||20.3|-5.0|0.2047
91632539|NCT01200758|183157840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.68|5.71||||||||5.71|0.68|
91632540|NCT01200758|183157841|SUPERIORITY_OR_OTHER||Difference in response rates|-0.49||||0.8911|TWO_SIDED|95.0|-7.7|6.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson.|||6.8|-7.7|0.8911
91632541|NCT01200758|183157841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.56|1.65||||||||1.65|0.56|
91632542|NCT01200758|183157842|SUPERIORITY_OR_OTHER||Difference in CRR|17.86||||0.0335|TWO_SIDED|95.0|0.8|35.0|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||35.0|0.8|0.0335
91632543|NCT01200758|183157842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|1.06|4.78||||||||4.78|1.06|
91632544|NCT01200758|183157843|SUPERIORITY_OR_OTHER||Difference in response rates|-6.58||||0.2331|TWO_SIDED|95.0|-17.8|4.6|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.6|-17.8|0.2331
91632545|NCT01200758|183157843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.44|1.22||||||||1.22|0.44|
91632546|NCT01200758|183157844|SUPERIORITY_OR_OTHER||Difference in response rates|0.49||||0.9157|TWO_SIDED|95.0|-8.8|9.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||9.8|-8.8|0.9157
91632547|NCT01200758|183157844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
91632548|NCT01200758|183157845|SUPERIORITY_OR_OTHER||Difference in response rates|-7.28||||0.1715|TWO_SIDED|95.0|-18.0|3.5|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||3.5|-18.0|0.1715
91632549|NCT01200758|183157845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.52|1.22||||||||1.22|0.52|
91632550|NCT01200758|183157846|SUPERIORITY_OR_OTHER||Difference in response rates|-0.18||||0.9671|TWO_SIDED|95.0|-9.2|8.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||8.8|-9.2|0.9671
91632551|NCT01200758|183157846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
91632552|NCT01200758|183157848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.5526|TWO_SIDED|95.0|0.64|1.26|||Wald test|||||1.26|0.64|0.5526
91632553|NCT01200758|183157850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.71|1.36|||Wald test|||||1.36|0.71|0.9115
91632554|NCT01200758|183157853|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.24|1.53||||||The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.||1.53|1.24|
91632555|NCT01200758|183157854|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.941|||||TWO_SIDED|95.0|0.872|1.015||||||||1.015|0.872|
91632556|NCT01828567|183157883|OTHER|A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.|Odds Ratio (OR)|2.54|||<|0.0001|TWO_SIDED|95.0|1.66|3.89|||Regression, Logistic|||The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.||3.89|1.66|<.0001
91632557|NCT01828567|183157885|OTHER||Mean Difference (Final Values)|1.5||||0.204|TWO_SIDED|95.0|-0.8|3.7||A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.|For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.||3.7|-0.8|0.204
91632558|NCT01828567|183157886|EQUIVALENCE|This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.|Mean Difference (Final Values)|2.5||||0.03|TWO_SIDED|95.0|0.2|4.7||A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.|||4.7|0.2|0.030
91632559|NCT01828567|183157888|EQUIVALENCE|This model assumes the groups have equal baseline means|Mean Difference (Final Values)|0.7||||0.33|TWO_SIDED|95.0|-0.7|2.2|||Repeated Measures|A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.|Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.||2.2|-0.7|0.330
91632560|NCT01099761|183157893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||ANCOVA|||||||0.023
91632561|NCT01099761|183157893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||||||0.012
91632562|NCT01099761|183157893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435|TWO_SIDED||||||ANCOVA|||||||0.435
91632563|NCT01099761|183157894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
91632564|NCT03325010|183157901|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1768|TWO_SIDED|95.0|-5.2|1.0||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||1.0|-5.2|0.1768
91632565|NCT03325010|183157902|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1095|TWO_SIDED|95.0|-0.6|0.1||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary outcome measure was statistically significant.|Mixed Models Analysis|||||0.1|-0.6|0.1095
91632566|NCT03325010|183157903|SUPERIORITY||Risk Difference (RD)|3.0||||0.819|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg).||||||0.8190
91484271|NCT05108922|182842179|SUPERIORITY||LS Mean difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|6.333||0.028|TWO_SIDED|95.0|-27.07|-1.59||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-1.59|-27.07|0.028
91632567|NCT03325010|183157904|SUPERIORITY||Risk Difference (RD)|33.6||||0.0008|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg)||||||0.0008
91632568|NCT02614261|183157905|SUPERIORITY||LSMean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.92|-1.26|||Mixed Models Analysis|||||-1.26|-2.92|<.001
91632569|NCT02614261|183157905|SUPERIORITY||LSMean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.71|-1.05|||Mixed Models Analysis|||||-1.05|-2.71|<.001
91632570|NCT02614261|183157906|SUPERIORITY||Odds Ratio (OR)|1.623||||0.004|TWO_SIDED|95.0|1.167|2.256|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%,||2.256|1.167|.004
91632571|NCT02614261|183157906|SUPERIORITY||Odds Ratio (OR)|1.788|||<|0.001|TWO_SIDED|95.0|1.291|2.474|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%||2.474|1.291|<.001
91632572|NCT02614261|183157906|SUPERIORITY||Odds Ratio (OR)|1.498||||0.102|TWO_SIDED|95.0|0.923|2.43|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.430|0.923|.102
91484272|NCT05108922|182842180|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids.|LS Mean difference (Final Values)|7.831|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-0.226|15.889||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||15.889|-0.226|
91484273|NCT01854658|182842212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
91666754|NCT05223868|183227573|SUPERIORITY||||||=|0.318||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Fatigue||||=0.318
91666755|NCT05223868|183227573|SUPERIORITY||||||=|0.207||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Fatigue||||=0.207
91666756|NCT05223868|183227573|SUPERIORITY||||||=|0.117||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Fatigue||||=0.117
91484274|NCT01854658|182842212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
91484275|NCT01854658|182842212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
91484276|NCT01854658|182842212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
91484277|NCT01854658|182842212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
91484278|NCT01854658|182842212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
91484279|NCT02007512|182842285|OTHER||Hazard Ratio (HR)|0.82||||0.3631|TWO_SIDED|95.0|0.535|1.257|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.257|0.535|0.3631
91484280|NCT02007512|182842285|OTHER||Hazard Ratio (HR)|1.022||||0.9212|TWO_SIDED|95.0|0.659|1.586|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.586|0.659|0.9212
91484281|NCT02007512|182842286|OTHER||Hazard Ratio (HR)|0.442||||0.0335|TWO_SIDED|95.0|0.205|0.955|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.955|0.205|0.0335
91484282|NCT02007512|182842286|OTHER||Hazard Ratio (HR)|0.554||||0.1936|TWO_SIDED|95.0|0.225|1.363|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.363|0.225|0.1936
91484283|NCT02007512|182842303|OTHER||Hazard Ratio (HR)|0.928||||0.7378|TWO_SIDED|95.0|0.599|1.438|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.438|0.599|0.7378
91632573|NCT02614261|183157906|SUPERIORITY||Odds Ratio (OR)|1.819||||0.011|TWO_SIDED|95.0|1.146|2.888|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.888|1.146|.011
91632574|NCT02614261|183157906|SUPERIORITY||Odds Ratio (OR)|0.761||||0.729|TWO_SIDED|95.0|0.163|3.563|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||3.563|0.163|0.729
91632575|NCT02614261|183157906|SUPERIORITY||Odds Ratio (OR)|1.897||||0.276|TWO_SIDED|95.0|0.6|5.998|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||5.998|0.600|.276
91632576|NCT02614261|183157907|SUPERIORITY||LSMean Difference|5.06|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.12|7.99|||Mixed Models Analysis|||||7.99|2.12|<.001
91632577|NCT02614261|183157907|SUPERIORITY||LSMean Difference|6.29|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|3.03|9.55|||Mixed Models Analysis|||||9.55|3.03|<.001
91632578|NCT02614261|183157908|SUPERIORITY||LSMean Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-3.27|-1.76|||Mixed Models Analysis|||||-1.76|-3.27|<.001
91632579|NCT02614261|183157908|SUPERIORITY||LSMean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.77|-1.26|||Mixed Models Analysis|||||-1.26|-2.77|<.001
91632580|NCT02614261|183157909|SUPERIORITY||LSMean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||||0.06|-0.34|.181
91632581|NCT02614261|183157909|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.48|-0.08|||Mixed Models Analysis|||||-0.08|-0.48|.006
91632582|NCT02614261|183157910|SUPERIORITY||LSMean Difference|-22.71|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.74|-13.69|||Mixed Models Analysis|||||-13.69|-31.74|<.001
91632583|NCT02614261|183157910|SUPERIORITY||LSMean Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.09|-9.09|||Mixed Models Analysis|||||-9.09|-27.09|<.001
91632584|NCT02614261|183157911|SUPERIORITY||LSMean Difference|-8.74|STANDARD_ERROR_OF_MEAN|3.9||0.025|TWO_SIDED|95.0|-16.39|-1.08|||ANCOVA|||||-1.08|-16.39|.025
91632585|NCT02614261|183157911|SUPERIORITY||LSMean Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.88||0.157|TWO_SIDED|95.0|-13.1|2.12|||ANCOVA|||||2.12|-13.10|.157
91666757|NCT05223868|183227573|SUPERIORITY||||||=|0.156||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Sleep Disturbance||||=0.156
91666758|NCT05223868|183227573|SUPERIORITY||||||=|0.019||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Sleep Disturbance||||=0.019
91632586|NCT02614261|183157912|SUPERIORITY|||||||0.263|||||||Cochran-Mantel-Haenszel|||||||.263
91666759|NCT05223868|183227573|SUPERIORITY||||||=|0.004||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Sleep Disturbance||||=0.004
91666760|NCT05223868|183227573|SUPERIORITY||||||=|0.228||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Sleep Disturbance||||=0.228
91666761|NCT05223868|183227573|SUPERIORITY||||||=|0.034||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Sleep Disturbance||||=0.034
91666762|NCT05223868|183227573|SUPERIORITY||||||=|0.197||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Social Roles and Activities||||=0.197
91666763|NCT05223868|183227573|SUPERIORITY||||||=|0.107||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Social Roles and Activities||||=0.107
91666764|NCT05223868|183227573|SUPERIORITY||||||=|0.606||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Social Roles and Activities||||=0.606
91666765|NCT05223868|183227573|SUPERIORITY||||||=|0.004||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Social Roles and Activities||||=0.004
91666766|NCT05223868|183227573|SUPERIORITY||||||=|0.005||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Social Roles and Activities||||=0.005
91666767|NCT05223868|183227573|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Pain Interference||||<0.001
91666768|NCT05223868|183227573|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Pain Interference||||<0.001
91666769|NCT05223868|183227573|SUPERIORITY||||||=|0.005||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Pain Interference||||=0.005
91666770|NCT05223868|183227573|SUPERIORITY||||||=|0.01||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Pain Interference||||=0.010
91666771|NCT05223868|183227573|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Mixed-Effect Model Repeated Measure|||Pain Interference||||<0.001
91666772|NCT05223868|183227574|SUPERIORITY||||||=|0.16||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Physical Function||||=0.160
91666773|NCT05223868|183227574|SUPERIORITY||||||=|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Physical Function||||=0.001
91666774|NCT05223868|183227574|SUPERIORITY||||||=|0.008||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Physical Function||||=0.008
91666775|NCT05223868|183227574|SUPERIORITY||||||=|0.006||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Physical Function||||=0.006
91666776|NCT05223868|183227574|SUPERIORITY||||||=|0.003||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Physical Function||||=0.003
91666777|NCT05223868|183227574|SUPERIORITY||||||=|0.818||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Anxiety||||=0.818
91666778|NCT05223868|183227574|SUPERIORITY||||||=|0.179||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Anxiety||||=0.179
91666779|NCT05223868|183227574|SUPERIORITY||||||=|0.03||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Anxiety||||=0.030
91632587|NCT02614261|183157912|SUPERIORITY|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||.290
91632588|NCT00113555|183157940|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|1.05|<|0.001|TWO_SIDED|95.0|-1.325|-1.003|||Wilcoxon (Mann-Whitney)|||Wilcoxon's matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.||-1.003|-1.325|<0.001
91632589|NCT04474366|183157949|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||||||0.72
91632590|NCT01700140|183157959|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
91632591|NCT01700140|183157959|SUPERIORITY_OR_OTHER|||||||0.2284|||||||Fisher Exact|||||||0.2284
91632592|NCT01700140|183157959|SUPERIORITY_OR_OTHER|||||||0.2549|||||||Cochran-Armitage test|||||||0.2549
91666780|NCT05223868|183227574|SUPERIORITY||||||=|0.267||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Anxiety||||=0.267
91666781|NCT05223868|183227574|SUPERIORITY||||||=|0.022||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Anxiety||||=0.022
91666782|NCT05223868|183227574|SUPERIORITY||||||=|0.62||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Depression||||=0.620
91666783|NCT05223868|183227574|SUPERIORITY||||||=|0.24||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Depression||||=0.240
91666784|NCT05223868|183227574|SUPERIORITY||||||=|0.71||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Depression||||=0.710
91666785|NCT05223868|183227574|SUPERIORITY||||||=|0.341||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Depression||||=0.341
91666786|NCT05223868|183227574|SUPERIORITY||||||=|0.204||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Depression||||=0.204
91666787|NCT05223868|183227574|SUPERIORITY||||||=|0.786||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Fatigue||||=0.786
91484284|NCT02007512|182842303|OTHER||Hazard Ratio (HR)|0.968||||0.8817|TWO_SIDED|95.0|0.632|1.483|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.483|0.632|0.8817
91484285|NCT02007512|182842304|OTHER||Hazard Ratio (HR)|0.522||||0.127|TWO_SIDED|95.0|0.224|1.217|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.217|0.224|0.1270
91484286|NCT02007512|182842304|OTHER||Hazard Ratio (HR)|0.37||||0.0359|TWO_SIDED|95.0|0.143|0.961|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.961|0.143|0.0359
91666788|NCT05223868|183227574|SUPERIORITY||||||=|0.597||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Fatigue||||=0.597
91666789|NCT05223868|183227574|SUPERIORITY||||||=|0.023||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Fatigue||||=0.023
91666790|NCT05223868|183227574|SUPERIORITY||||||=|0.438||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Fatigue||||=0.438
91666791|NCT05223868|183227574|SUPERIORITY||||||=|0.017||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Fatigue||||=0.017
91666792|NCT05223868|183227574|SUPERIORITY||||||=|0.419||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Sleep Disturbance||||=0.419
91666793|NCT05223868|183227574|SUPERIORITY||||||=|0.08||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Sleep Disturbance||||=0.080
91666794|NCT05223868|183227574|SUPERIORITY||||||=|0.006||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Sleep Disturbance||||=0.006
91666795|NCT05223868|183227574|SUPERIORITY||||||=|0.421||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Sleep Disturbance||||=0.421
91666796|NCT05223868|183227574|SUPERIORITY||||||=|0.025||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Sleep Disturbance||||=0.025
91484287|NCT05402020|182842312|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first moderate or severe COPD exacerbations) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.15|0.87|
91666797|NCT05223868|183227574|SUPERIORITY||||||=|0.47||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Social Roles and Activities||||=0.470
91666798|NCT05223868|183227574|SUPERIORITY||||||=|0.023||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Social Roles and Activities||||=0.023
91666799|NCT05223868|183227574|SUPERIORITY||||||=|0.002||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Social Roles and Activities||||=0.002
91666800|NCT05223868|183227574|SUPERIORITY||||||=|0.04||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Social Roles and Activities||||=0.040
91666801|NCT05223868|183227574|SUPERIORITY||||||=|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Social Roles and Activities||||=0.001
91666802|NCT05223868|183227574|SUPERIORITY||||||=|0.013||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Pain Interference||||=0.013
91666803|NCT05223868|183227574|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Pain Interference||||<0.001
91484288|NCT05402020|182842313|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.53|0.85|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (triple therapy escalation) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||0.85|0.53|
91666804|NCT05223868|183227574|SUPERIORITY||||||=|0.004||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Pain Interference||||=0.004
91666805|NCT05223868|183227574|SUPERIORITY||||||=|0.038||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Pain Interference||||=0.038
91666806|NCT05223868|183227574|SUPERIORITY||||||<|0.001||||||Dose response assessment was adjusted for multiplicity. Pairwise comparisons between each dose vs placebo were not.|Cochran-Mantel-Haenszel|||Pain Interference||||<0.001
91666807|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.337|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to post-intervention (d1)||||
91484289|NCT05402020|182842314|OTHER||Incidence difference|-37.9|||||TWO_SIDED|95.0|-60.1|-15.8|||||Incidence difference calculated as \[incidence rate of Tio/Olo\]-\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||-15.8|-60.1|
91484290|NCT05402020|182842314|OTHER||Incidence Rate Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||||Ratio calculated as \[incidence rate of Tio/Olo\]/\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||0.85|0.51|
91484291|NCT05402020|182842315|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.36|1.93|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first hospitalization for community-acquired pneumonia after initiation of study drug) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.93|0.36|
91632593|NCT01700140|183157960|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91632594|NCT01700140|183157960|SUPERIORITY_OR_OTHER|||||||0.1527|||||||Fisher Exact|||||||0.1527
91632595|NCT01700140|183157960|SUPERIORITY_OR_OTHER|||||||0.1864|||||||Cochran-Armitage test|||||||0.1864
91632596|NCT01700140|183157961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.918||||0.8361|TWO_SIDED|95.0|0.266|3.172|||Generalized Wilcoxon test|||||3.172|0.266|0.8361
91632597|NCT01700140|183157961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0724|TWO_SIDED|95.0|0.144|1.237|||Generalized Wilcoxon test|||||1.237|0.144|0.0724
91632598|NCT01700140|183157962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213||||0.6466|TWO_SIDED|95.0|0.616|2.388|||Generalized Wilcoxon test|||||2.388|0.616|0.6466
91632599|NCT01700140|183157962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.828||||0.2701|TWO_SIDED|95.0|0.566|1.21|||Generalized Wilcoxon test|||||1.210|0.566|0.2701
91632600|NCT01700140|183157963|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||1.0000
91632601|NCT01700140|183157963|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||0.1051
91632602|NCT01700140|183157963|SUPERIORITY_OR_OTHER|||||||0.4856|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.4856
91632603|NCT01700140|183157963|SUPERIORITY_OR_OTHER|||||||0.1047|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.1047
91632604|NCT01700140|183157963|SUPERIORITY_OR_OTHER|||||||0.1617|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.1617
91632605|NCT01700140|183157963|SUPERIORITY_OR_OTHER|||||||0.3099|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.3099
91632606|NCT01700140|183157964|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||1.0000
91632607|NCT01700140|183157964|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||0.1051
91632608|NCT01700140|183157964|SUPERIORITY_OR_OTHER|||||||0.6761|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.6761
91632609|NCT01700140|183157964|SUPERIORITY_OR_OTHER|||||||0.3513|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.3513
91632610|NCT01700140|183157964|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.2060
91632611|NCT01700140|183157964|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.0511
91632612|NCT00864123|183158119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|6.3|<|0.05||95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
91632613|NCT00864123|183158120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|1.1|<|0.05|TWO_SIDED|95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
91632614|NCT04221945|183158155|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0004|TWO_SIDED|95.0|0.59|0.87||One sided p-value|Log Rank|Stratified by planned type of external beam radiation therapy (EBRT), stage at screening, and planned total radiotherapy dose.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.87|0.59|0.0004
91632615|NCT04221945|183158156|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0076|TWO_SIDED|95.0|0.57|0.94||One sided p-value|Log Rank|Stratified by planned type of external beam radiation therapy (EBRT), stage at screening, and planned total radiotherapy dose.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.94|0.57|0.0076
91632616|NCT04221945|183158157|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0011|TWO_SIDED|95.0|0.58|0.89||One-sided p-value|Log Rank|Stratified by planned type of EBRT, stage at screening, and planned total radiotherapy dose.|Based on Cox regression model with Efron's method of tie handling|||0.89|0.58|0.0011
91632617|NCT04221945|183158158|OTHER||Difference in Survival Rate|10.9|||||TWO_SIDED|95.0|5.1|16.7|||||Pembrolizumab minus Placebo|||16.7|5.1|
91666808|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.337|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to post-intervention (d2)||||
91666809|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.3|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to 1-month post-intervention (d1)||||
91666810|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.159|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to 1-month post-intervention (d2)||||
91484292|NCT05402020|182842316|OTHER||Annualized rate ratio|0.92|||||TWO_SIDED|95.0|0.81|1.03|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.03|0.81|
91666811|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.065|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to post-intervention (d1)||||
91666812|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.084|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to post-intervention (d2)||||
91666813|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.316|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to 1-month post-intervention (d1)||||
91525801|NCT03587142|182927115|SUPERIORITY||Mean Difference (Net)|-1.02||||0.74|TWO_SIDED|95.0|-6.93|4.89||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||4.89|-6.93|0.74
91666814|NCT05029687|183227576|OTHER|Effect size (Cohen's d)|Cohen's d|1.048|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to 1-month post-intervention (d2)||||
91666815|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.846|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|"Comparison of effect size: baseline to post-intervention for the statement: Teach an adult how to lower their high BP. (d1)"||||
91666816|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.821|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|"Comparison of effect size: baseline to post-intervention for the statement: Teach an adult how to lower their high BP. (d2)"||||
91666817|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.87|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|"Comparison of effect size: baseline to 1-month post-intervention for the statement: Teach an adult how to lower their high BP. (d1)"||||
91666818|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.782|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|"Comparison of effect size: baseline to 1-month post-intervention for the statement: Teach an adult how to lower their high BP. (d2)"||||
91666819|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.643|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|"Comparison of effect size: baseline to post-intervention for the statement: Encourage an adult to lower their high BP. (d1)"||||
91666820|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.616|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|"Comparison of effect size: baseline to post-intervention for the statement: Encourage an adult to lower their high BP. (d2)"||||
91666821|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.724|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|"Comparison of effect size: baseline to 1-month post-intervention for the statement: Encourage an adult to lower their high BP. (d1)"||||
91714344|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.252||0.5191||95.0|-0.33|0.66|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.66|-0.33|0.5191
91484293|NCT05402020|182842317|OTHER||Annualized rate ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.18|0.87|
91484294|NCT03180684|182842389|SUPERIORITY|||||||0.0071|||||||Clopper Pearson|A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.||||||0.0071
91632618|NCT04221945|183158159|OTHER||Difference in Survival Rate|7.9|||||TWO_SIDED|95.0|2.3|13.5|||||Pembrolizumab minus Placebo|||13.5|2.3|
91632619|NCT04221945|183158160|OTHER||Difference in Survival Rate|7.4|||||TWO_SIDED|95.0|2.3|12.5|||||Pembrolizumab minus Placebo|||12.5|2.3|
91632620|NCT04221945|183158161|OTHER||Difference in Percentage|3.3||||0.1307|TWO_SIDED|95.0|-2.5|9.1|||One-sided p-value for testing||Pembrolizumab minus Placebo||Miettinen \& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.|9.1|-2.5|0.1307
91632621|NCT04221945|183158162|OTHER||Difference in Percentage|0.7||||0.4082|TWO_SIDED|95.0|-5.2|6.7|||One-sided p-value for testing||Pembrolizumab minus Placebo||Miettinen \& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.|6.7|-5.2|0.4082
91632622|NCT04221945|183158163|OTHER||Difference in Percentage|3.6||||0.0496|TWO_SIDED|95.0|-0.7|7.9|||One-sided p-value for testing.||Pembrolizumab minus Placebo||Miettinen \& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.|7.9|-0.7|0.0496
91632623|NCT04221945|183158164|OTHER||Difference in Percentage|2.2||||0.1244|TWO_SIDED|95.0|-1.5|5.9|||One-sided p-value for testing.||Pembrolizumab minus Placebo||Miettinen \& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.|5.9|-1.5|0.1244
91632624|NCT04221945|183158165|OTHER||Hazard Ratio (HR)|0.73||||0.001|TWO_SIDED|95.0|0.59|0.89||One-sided p-value|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.89|0.59|0.0010
91632625|NCT04221945|183158166|OTHER||Hazard Ratio (HR)|0.72||||0.0016|TWO_SIDED|95.0|0.58|0.9||One-sided p-value|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.90|0.58|0.0016
91666822|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.683|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|"Comparison of effect size: baseline to 1-month post-intervention for the statement: Encourage an adult to lower their high BP. (d2)"||||
91666823|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.72|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|"Comparison of effect size: baseline to post-intervention for the statement: Help an adult lower their BP. (d1)"||||
91666824|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.667|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|"Comparison of effect size: baseline to post-intervention for the statement: Help an adult lower their BP. (d2)"||||
91632626|NCT04221945|183158167|OTHER||Hazard Ratio (HR)|0.73||||0.0083|TWO_SIDED|95.0|0.56|0.95||One-sided p-value|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.95|0.56|0.0083
91632627|NCT04221945|183158168|OTHER||Hazard Ratio (HR)|0.69||||0.0015|TWO_SIDED|95.0|0.54|0.88||One-sided p-value|Log Rank|Stratified by planned type of external beam radiation therapy (EBRT), stage at screening, and planned total radiotherapy dose.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.88|0.54|0.0015
91632628|NCT04221945|183158169|OTHER||Difference LS Means|0.07||||0.9593|TWO_SIDED|95.0|-2.66|2.8|||cLDA model||Pembrolizumab minus placebo||Based on a cLDA model with the patient-reported outcome (PRO) scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.|2.80|-2.66|0.9593
91632629|NCT04221945|183158170|OTHER||Difference LS Means|0.68||||0.5145|TWO_SIDED|95.0|-1.36|2.71|||cLDA model||Pembrolizumab minus placebo||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.|2.71|-1.36|0.5145
91632630|NCT04221945|183158171|OTHER||Difference LS Means|0.75||||0.2953|TWO_SIDED|95.0|-0.65|2.15|||cLDA model||Pembrolizumab minus placebo||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.|2.15|-0.65|0.2953
91632631|NCT05740566|183158233|SUPERIORITY||Hazard Ratio (HR)|0.599|||<|0.001|TWO_SIDED|95.0|0.468|0.768||P-value is calculated using a stratified log-rank test.|Stratified log-rank test||Hazard ratios and 95% CIs are estimated using a stratified Cox proportional hazards model; a hazard ratio \<1.0 indicates a better survival of tarlatamab arm.|||0.768|0.468|<0.001
91632632|NCT06210035|183158277|SUPERIORITY||F test|6.21||||0.003|TWO_SIDED||||||ANOVA|||||||0.003
91632633|NCT06210035|183158278|SUPERIORITY||F test|0.78||||0.46|TWO_SIDED||||||ANOVA|||||||0.460
91632634|NCT06210035|183158279|SUPERIORITY||F test|2.13||||0.127|TWO_SIDED||||||ANOVA|||||||0.127
91632635|NCT06210035|183158280|SUPERIORITY||F test|0.004||||0.952|TWO_SIDED||||||ANOVA|||||||0.952
91632636|NCT01029691|183158282|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||unadjusted systolic blood pressure at baseline between groups||||0.45
91632637|NCT01029691|183158282|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at baseline between groups||||0.66
91632638|NCT01029691|183158282|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Unadjusted systolic blood pressure at week 1||||0.61
91632639|NCT01029691|183158282|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at week 1||||0.75
91632640|NCT01029691|183158283|SUPERIORITY|||||||0.085|||||||Chi-squared|||||||0.085
91632641|NCT01029691|183158284|SUPERIORITY|||||||0.012||||||Unadjusted|t-test, 2 sided|||||||0.012
91632642|NCT01029691|183158288|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.4
91484295|NCT03180684|182842389|SUPERIORITY|||||||0.0004|||||||Clopper Pearson|1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.||||||0.0004
91484296|NCT01460368|182842428|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|||||TWO_SIDED|90.0|-1.38|2.63|||||Treatment comparison at 2 hours.|||2.63|-1.38|
91484297|NCT01460368|182842428|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.69|||||TWO_SIDED|90.0|1.67|5.71|||||Treatment comparison at 4 hours.|||5.71|1.67|
91484298|NCT01460368|182842428|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.14|||||TWO_SIDED|90.0|7.12|11.16|||||Treatment comparison at 6 hours.|||11.16|7.12|
91484299|NCT01460368|182842428|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.08|||||TWO_SIDED|90.0|7.1|11.07|||||Treatment comparison at 8 hours.|||11.07|7.10|
91632643|NCT05492877|183158314|SUPERIORITY||Hazard Ratio (HR)|1.071||||0.599|TWO_SIDED|90.0|0.869|1.32|||Regression, Cox||||The p-value was based on a 2-sided log rank test stratified by region|1.320|0.869|0.599
91632644|NCT05492877|183158317|SUPERIORITY||Hazard Ratio (HR)|1.234|||||TWO_SIDED|90.0|0.882|1.726|||Regression, Cox|||||1.726|0.882|
91632645|NCT03737318|183158435|SUPERIORITY||Treatment × Time interaction (β)|106.41|STANDARD_ERROR_OF_MEAN|22.11|<|0.0001|TWO_SIDED|95.0|63.06|149.76||Two-sided test of the treatment × time interaction. Alpha = 0.05.|Regression, Linear||Sign convention: A more positive β indicates a more positive Session 1→3 slope in the traditional treatment group relative to the biofeedback group (reference level).|Following our preregistered statistical analysis plan, the visual-acoustic and ultrasound biofeedback groups were pooled for comparison of biofeedback versus traditional treatment.||149.76|63.06|< .0001
91666825|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.72|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|"Comparison of effect size: baseline to 1-month post-intervention for the statement: Help an adult lower their BP. (d1)"||||
91484300|NCT01460368|182842428|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.15|||||TWO_SIDED|90.0|-2.14|1.85|||||Treatment comparison at 12 hours.|||1.85|-2.14|
91666826|NCT05029687|183227579|OTHER|Effect size (Cohen's d)|Cohen's d|0.627|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|"Comparison of effect size: baseline to 1-month post-intervention for the statement: Help an adult lower their BP. (d2)"||||
91666827|NCT05029687|183227581|OTHER|Effect size (Cohen's d)|Cohen's d|1.457|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to post-intervention (d1)||||
91484301|NCT01460368|182842428|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.63|||||TWO_SIDED|90.0|1.63|5.63|||||Treatment comparison at 24 hours.|||5.63|1.63|
91484302|NCT01460368|182842429|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|8.07|||||TWO_SIDED|90.0|5.21|10.94|||||Treatment comparison at 2 hours.|||10.94|5.21|
91484303|NCT01460368|182842429|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|7.69|13.43|||||Treatment comparison at 4 hours.|||13.43|7.69|
91484304|NCT02047227|182842430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.054|TWO_SIDED|95.0|-0.4741|0.003|||Poisson Regression Model|||||0.003|-0.4741|0.054
91484305|NCT01385371|182842441|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.98|||<|0.001||95.0|-1.2|-0.4|||Wilcoxon Rank Sum Test|||||-0.4|-1.2|<0.001
91484306|NCT01385371|182842442|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.001|TWO_SIDED|95.0|-0.7|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.7|0.001
91632646|NCT03737318|183158436|SUPERIORITY||Treatment × Time (linear) interaction (β|-3.12|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-4.85|-1.4||Two-sided test of the treatment × time interaction. Alpha = 0.05.|Regression, Linear|Test of treatment × time (Pre, Post) interaction.|Sign convention: Negative β indicates a smaller linear time slope in the traditional treatment group relative to the biofeedback group (reference level)|Following our preregistered statistical analysis plan, the visual-acoustic and ultrasound biofeedback groups were pooled for comparison of biofeedback versus traditional treatment.||-1.40|-4.85|< .001
91632647|NCT03737318|183158437|SUPERIORITY||Treatment × Time linear interaction (β)|0.0147|STANDARD_ERROR_OF_MEAN|0.0594||0.8|TWO_SIDED|95.0|-0.1|0.13||Two-sided test of the treatment × time interaction. Alpha = 0.05.|Regression, Linear|Test of treatment (Traditional vs biofeedback) × linear time.|Sign convention: positive β indicates a larger linear time slope in the traditional group relative to the biofeedback group (reference level)|Following our preregistered statistical analysis plan, the visual-acoustic and ultrasound biofeedback groups were pooled for comparison of biofeedback versus traditional treatment.||0.13|-0.10|.80
91632648|NCT01603628|183158473|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26||||0.01|TWO_SIDED|95.0|-0.453|-0.063||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.063|-0.453|0.010
91632649|NCT01603628|183158473|SUPERIORITY||LS Mean Difference|-0.21||||0.033|TWO_SIDED|95.0|-0.405|-0.018||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.018|-0.405|0.033
91484307|NCT01385371|182842443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.33|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||Wilcoxon Rank Sum Test|||||-0.5|-1.4|<0.001
91484308|NCT01385371|182842444|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.13||||0.027||95.0|-0.2|0.0|||Wilcoxon Rank Sum Test|||||0.0|-0.2|0.027
91484309|NCT01385371|182842445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0003|TWO_SIDED|95.0|-0.73|-0.22||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.22|-0.73|0.0003
91484310|NCT01385371|182842446|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.9|<0.001
91484311|NCT01385371|182842447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0001|TWO_SIDED|95.0|-0.94|-0.31||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.31|-0.94|0.0001
91632650|NCT01603628|183158474|SUPERIORITY||LS Mean Difference|0.29||||0.023|TWO_SIDED|95.0|0.04|0.532||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.532|0.040|0.023
91632651|NCT01603628|183158474|SUPERIORITY||LS Mean Difference|0.13||||0.299|TWO_SIDED|95.0|-0.115|0.374||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.374|-0.115|0.299
91632652|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.41||||0.005|TWO_SIDED|95.0|0.126|0.704||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.704|0.126|0.005
91632653|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.29||||0.047|TWO_SIDED|95.0|0.004|0.573||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.573|0.004|0.047
91632654|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.45||||0.004|TWO_SIDED|95.0|0.145|0.756||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.756|0.145|0.004
91666828|NCT05029687|183227581|OTHER|Effect size (Cohen's d)|Cohen's d|1.691|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to post-intervention (d2)||||
91666829|NCT05029687|183227581|OTHER|Effect size (Cohen's d)|Cohen's d|1.841|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to 1-month post-intervention (d1)||||
91666830|NCT05029687|183227581|OTHER|Effect size (Cohen's d)|Cohen's d|1.451|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to 1-month post-intervention (d2)||||
91666831|NCT05029687|183227583|OTHER|Effect size (Cohen's d)|Cohen's d|0.763|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to post-intervention (d1)||||
91666832|NCT05029687|183227583|OTHER|Effect size (Cohen's d)|Cohen's d|1.266|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to post-intervention (d2)||||
91484312|NCT01385371|182842448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.15||||0.644|TWO_SIDED|95.0|-0.4|0.6|||Wilcoxon Rank Sum Test|||||0.6|-0.4|0.644
91666833|NCT05029687|183227583|OTHER|Effect size (Cohen's d)|Cohen's d|0.894|||||TWO_SIDED||||||||d1 is mean change from baseline to follow-up divided by the standard deviation of the outcome at baseline to provide an effect size that might approximate one found in a randomized clinical trial if the placebo group saw no change from baseline.|Comparison of effect size: baseline to 1-month post-intervention (d1)||||
91632655|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.44||||0.004|TWO_SIDED|95.0|0.141|0.74||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.740|0.141|0.004
91632656|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.49||||0.001|TWO_SIDED|95.0|0.191|0.797||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.797|0.191|0.001
91484313|NCT02436681|182842489|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91632657|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.22||||0.153|TWO_SIDED|95.0|-0.081|0.541||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.541|-0.081|0.153
91484314|NCT02436681|182842491|SUPERIORITY||||||=|0.0468|||||||t-test, 1 sided|||||||= 0.0468
91632658|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.41||||0.01|TWO_SIDED|95.0|0.1|0.711||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.711|0.100|0.010
91632659|NCT01603628|183158475|SUPERIORITY||LS Mean Difference|0.27||||0.078|TWO_SIDED|95.0|-0.031|0.571||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.571|-0.031|0.078
91484315|NCT02436681|182842493|SUPERIORITY||||||=|0.014|||||||t-test, 1 sided|||||||=0.014
91484316|NCT02436681|182842494|SUPERIORITY||||||=|0.018|||||||t-test, 1 sided|||||||= 0.018
91666834|NCT05029687|183227583|OTHER|Effect size (Cohen's d)|Cohen's d|1.149|||||TWO_SIDED||||||||d2 is mean change from baseline to follow-up divided by the standard deviation of the change from baseline to follow-up, to provide an effect size that would be useful for planning similar before-after studies.|Comparison of effect size: baseline to 1-month post-intervention (d2)||||
91666835|NCT00874822|183227597|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|19.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|13.6|24.4|||Chi-squared, Corrected|||"Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163."||24.4|13.6|<0.0001
91666836|NCT02854800|183227599|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||A separate t-test for each row was used to compare dropouts and completers.||||<0.05
91666837|NCT02854800|183227601|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used to compare mean medication side effect ratings across the three arms/groups to determine whether one group had more severe symptoms that may have been related to study dropout.||||<0.05
91666838|NCT02854800|183227604|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Mixed ANOVA was used with Study Week (1-12) as the within-subjects, repeated-measures factor and Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
91666839|NCT02854800|183227605|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used for each side effect rating with Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
91666840|NCT02854800|183227606|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
91666841|NCT02854800|183227608|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
91666842|NCT01634139|183227617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.108|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.231|0.108|<0.0001
91666843|NCT01634139|183227617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.103|0.255|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.255|0.103|<0.0001
91666844|NCT01634139|183227618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.186|0.046|0.0012
91666845|NCT01634139|183227618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.188|0.048|0.0010
91666846|NCT01634139|183227618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.071|STANDARD_ERROR_OF_MEAN|0.036||0.0477|TWO_SIDED|95.0|0.001|0.142|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.142|0.001|0.0477
91666847|NCT01634139|183227618|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0059|TWO_SIDED|95.0|0.029|0.17|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.170|0.029|0.0059
91666848|NCT01634139|183227619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.062|0.185|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.185|0.062|<0.0001
91666849|NCT01634139|183227619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.065|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.188|0.065|<0.0001
91666850|NCT01634139|183227620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.095|0.212|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.212|0.095|<0.0001
91666851|NCT01634139|183227620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.157|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.098|0.215|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.215|0.098|<0.0001
91632660|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-1.99||||0.158|TWO_SIDED|95.0|-4.768|0.779||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||0.779|-4.768|0.158
91632661|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-3.25||||0.02|TWO_SIDED|95.0|-5.974|-0.524||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||-0.524|-5.974|0.020
91632662|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-1.42||||0.363|TWO_SIDED|95.0|-4.489|1.648||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||1.648|-4.489|0.363
91666852|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.186|0.046|0.0012
91666853|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose (Week 24)||0.188|0.048|0.0010
91666854|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.076|0.201|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.201|0.076|<0.0001
91666855|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.151|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.088|0.213|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.213|0.088|<0.0001
91666856|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.211|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (Week 24)||0.211|0.084|<0.0001
91666857|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.21|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (Week 24)||0.210|0.084|<0.0001
91666858|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.101|0.226|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (Week 24)||0.226|0.101|<0.0001
91666859|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.106|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (Week 24)||0.231|0.106|<0.0001
91484317|NCT02103218|182842500|SUPERIORITY|||||||0.62|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.62
91632663|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-2.11||||0.171|TWO_SIDED|95.0|-5.127|0.914||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||0.914|-5.127|0.171
91632664|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-3.33||||0.02|TWO_SIDED|95.0|-6.143|-0.525||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-0.525|-6.143|0.020
91632665|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-3.92||||0.006|TWO_SIDED|95.0|-6.688|-1.148||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-1.148|-6.688|0.006
91666860|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.116|0.24|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (Week 24)||0.240|0.116|<0.0001
91666861|NCT01634139|183227621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.114|0.238|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.238|0.114|<0.0001
91666862|NCT01634139|183227622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.038||0.0036|TWO_SIDED|95.0|0.036|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.184|0.036|0.0036
91666863|NCT01634139|183227622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.037||0.0152|TWO_SIDED|95.0|0.018|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.165|0.018|0.0152
91666864|NCT01634139|183227622|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0687|TWO_SIDED|95.0|-0.005|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.143|-0.005|0.0687
91666865|NCT01634139|183227622|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.038||0.1666|TWO_SIDED|95.0|-0.022|0.126|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.126|-0.022|0.1666
91484318|NCT02103218|182842501|SUPERIORITY|||||||0.15|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.15
91484319|NCT02103218|182842502|SUPERIORITY|||||||0.47|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.47
91484320|NCT02103218|182842503|SUPERIORITY|||||||0.29|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
91666866|NCT01634139|183227623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.171|0.013|0.0228
91666867|NCT01634139|183227623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.131|-0.027|0.1980
91666868|NCT01634139|183227623|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.062|STANDARD_ERROR_OF_MEAN|0.04||0.1256|TWO_SIDED|95.0|-0.017|0.141|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.141|-0.017|0.1256
91666869|NCT01634139|183227623|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053|STANDARD_ERROR_OF_MEAN|0.04||0.188|TWO_SIDED|95.0|-0.026|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.026|0.1880
91666870|NCT01634139|183227624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.034||0.0023|TWO_SIDED|95.0|0.037|0.172|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.172|0.037|0.0023
91714345|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.262||0.0817||95.0|-0.06|0.97|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.97|-0.06|0.0817
91484321|NCT02103218|182842504|SUPERIORITY||||||<|0.001|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||<0.001
91525802|NCT03587142|182927116|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.08|||ANCOVA|P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance \<0.002||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.08|-0.01|0.18
91666871|NCT01634139|183227624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.034||0.0255|TWO_SIDED|95.0|0.009|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.143|0.009|0.0255
91714346|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.253||0.1146||95.0|-0.1|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.90|-0.10|0.1146
91666872|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.171|0.013|0.0228
91666873|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose.(Week 24)||0.131|-0.027|0.1980
91666874|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0344|TWO_SIDED|95.0|0.006|0.15|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.150|0.006|0.0344
91666875|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.037||0.0696|TWO_SIDED|95.0|-0.005|0.139|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.139|-0.005|0.0696
91666876|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.109|STANDARD_ERROR_OF_MEAN|0.037||0.0032|TWO_SIDED|95.0|0.037|0.182|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (week 24)||0.182|0.037|0.0032
91666877|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.037||0.1044|TWO_SIDED|95.0|-0.012|0.132|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (week 24)||0.132|-0.012|0.1044
91525803|NCT03587142|182927117|SUPERIORITY||Mean Difference (Net)|-0.39||||0.97|TWO_SIDED|95.0|-20.42|19.64||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||19.64|-20.42|0.97
91632666|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-2.07||||0.254|TWO_SIDED|95.0|-5.621|1.491||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.491|-5.621|0.254
91632667|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-2.46||||0.165|TWO_SIDED|95.0|-5.935|1.014||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.014|-5.935|0.165
91632668|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-2.61||||0.078|TWO_SIDED|95.0|-5.517|0.296||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||0.296|-5.517|0.078
91632669|NCT01603628|183158476|SUPERIORITY||LS Mean Difference|-1.09||||0.451|TWO_SIDED|95.0|-3.944|1.758||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||1.758|-3.944|0.451
91632670|NCT01930487|183158477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.037|STANDARD_ERROR_OF_MEAN|0.011||0.0016|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0016
91632671|NCT01930487|183158478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.011||0.0249|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0249
91632672|NCT01930487|183158479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9147|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9147
91632673|NCT01930487|183158480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.59||0.007|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0070
91632674|NCT01930487|183158481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED||||||paired t-test, 2-sidede||dietary supplement with antioxidants - placebo|||||<0.0001
91632675|NCT01930487|183158482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.23||0.0476|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0476
91632676|NCT01930487|183158483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.0352|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0352
91632677|NCT01930487|183158484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0208|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0208
91632678|NCT01930487|183158485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
91632679|NCT01930487|183158486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0024|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0024
91666878|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.037||0.0027|TWO_SIDED|95.0|0.039|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (week 24)||0.186|0.039|0.0027
91632680|NCT01930487|183158487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.0081|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0081
91632681|NCT01930487|183158488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.008||0.8191|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8191
91632682|NCT01930487|183158489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.009||0.0482|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0482
91666879|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.093|STANDARD_ERROR_OF_MEAN|0.037||0.013|TWO_SIDED|95.0|0.02|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (week 24)||0.166|0.020|0.0130
91632683|NCT01930487|183158490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.023|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0230
91632684|NCT01930487|183158491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.008||0.1202|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1202
91632685|NCT01930487|183158492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|STANDARD_ERROR_OF_MEAN|0.83||0.0063|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0063
91632686|NCT01930487|183158493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.8||0.3347|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3347
91632687|NCT01930487|183158494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.35||0.0094|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0094
91632688|NCT01930487|183158495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0009
91666880|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025|TWO_SIDED|95.0|0.041|0.19|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (week 24)||0.190|0.041|0.0025
91792449|NCT02047318|183462640|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.53|STANDARD_DEVIATION|5.505||0.8218|TWO_SIDED|95.0|-6.31|5.24||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||5.24|-6.31|0.8218
91632689|NCT01930487|183158496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.34||0.0067|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0067
91632690|NCT01930487|183158497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.6938|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6938
91632691|NCT01930487|183158498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0805|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0805
91632692|NCT01930487|183158499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.29||0.2451|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2451
91632693|NCT01930487|183158500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0323|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0323
91632694|NCT01930487|183158501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.344|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3440
91632695|NCT01930487|183158502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0119|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0119
91632696|NCT01930487|183158503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
91632697|NCT01930487|183158504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.0137|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0137
91632698|NCT01930487|183158505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0866|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0866
91632699|NCT01930487|183158506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0656|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0656
91666881|NCT01634139|183227625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.038||0.0156|TWO_SIDED|95.0|0.017|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.166|0.017|0.0156
91666882|NCT01634139|183227626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.165|STANDARD_ERROR_OF_MEAN|0.11||0.1349|TWO_SIDED|95.0|-0.382|0.051|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.051|-0.382|0.1349
91632700|NCT01930487|183158507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.0626|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0626
91632701|NCT01930487|183158508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.013||0.81|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8100
91632702|NCT01930487|183158509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.01||0.9556|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9556
91632703|NCT01930487|183158510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3414|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3414
91632704|NCT01930487|183158511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.009||0.033|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0330
91632705|NCT01930487|183158512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3326|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3326
91632706|NCT01930487|183158513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.012||0.0348|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0348
91632707|NCT01930487|183158514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.012||0.2089|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2089
91632708|NCT01930487|183158515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.012||0.3738|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3738
91632709|NCT01930487|183158516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.447|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.4470
91632710|NCT01930487|183158517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.1||0.6382|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6382
91632711|NCT01930487|183158518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.012||0.0026|TWO_SIDED||||||paird t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0026
91632712|NCT01930487|183158519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.018||0.1045|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1045
91666883|NCT01634139|183227626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.209|STANDARD_ERROR_OF_MEAN|0.11||0.0588|TWO_SIDED|95.0|-0.425|0.008|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.008|-0.425|0.0588
91666884|NCT01634139|183227626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.154|STANDARD_ERROR_OF_MEAN|0.111||0.1675|TWO_SIDED|95.0|-0.372|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.065|-0.372|0.1675
91714347|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.253||0.0054||95.0|0.21|1.21|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.21|0.21|0.0054
91792450|NCT02047318|183462640|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.52|STANDARD_DEVIATION|2.001||0.5549|TWO_SIDED|95.0|-2.62|1.58||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||1.58|-2.62|0.5549
91632713|NCT01930487|183158520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6941|TWO_SIDED||||||paired t-test||dietary supplement with antioxidants - placebo|||||0.6941
91632714|NCT01930487|183158521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.017||0.0138|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0138
91632715|NCT02711553|183158522|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.4821|TWO_SIDED|80.0|0.904|1.395||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.395|0.904|0.4821
91632716|NCT02711553|183158522|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6417|TWO_SIDED|80.0|0.734|1.153||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.153|0.734|0.6417
91632717|NCT02711553|183158523|SUPERIORITY||Hazard Ratio (HR)|1.336||||0.087|TWO_SIDED|95.0|0.959|1.862|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.862|0.959|0.0870
91632718|NCT02711553|183158523|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7599|TWO_SIDED|95.0|0.669|1.342|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.342|0.669|0.7599
91632719|NCT02711553|183158524|SUPERIORITY||Odds Ratio (OR)|1.0||||0.878|TWO_SIDED|95.0|0.6|1.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||1.9|0.6|0.878
91632720|NCT02711553|183158524|SUPERIORITY||Odds Ratio (OR)|0.5||||0.023|TWO_SIDED|95.0|0.2|0.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||0.9|0.2|0.023
91632721|NCT02711553|183158525|SUPERIORITY||Odds Ratio (OR)|1.2||||0.68|TWO_SIDED|95.0|0.6|2.4|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.4|0.6|0.680
91632722|NCT02711553|183158525|SUPERIORITY||Odds Ratio (OR)|1.3||||0.499|TWO_SIDED|95.0|0.6|2.6|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.6|0.6|0.499
91632723|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.069|TWO_SIDED|95.0|-2.28|0.09||p-values are from Type 3 sums of squares mixed model repeated measures (MMRM) Model.|MMRM Model|Least Squares (LS) Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||0.09|-2.28|0.069
91632724|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.6||0.042|TWO_SIDED|95.0|-2.42|-0.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||-0.04|-2.42|0.042
91632725|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.51||0.112|TWO_SIDED|95.0|-1.83|0.19||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.19|-1.83|0.112
91632726|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.505|TWO_SIDED|95.0|-1.35|0.67||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.67|-1.35|0.505
91632727|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.116|TWO_SIDED|95.0|-1.56|0.17||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.17|-1.56|0.116
91632728|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.45||0.521|TWO_SIDED|95.0|-1.16|0.59||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.59|-1.16|0.521
91632729|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.62||0.008|TWO_SIDED|95.0|-2.87|-0.44||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||-0.44|-2.87|0.008
91632730|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.82|0.62||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||0.62|-1.82|0.335
91632731|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|0.89||0.001|TWO_SIDED|95.0|-4.69|-1.18||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||-1.18|-4.69|0.001
91484322|NCT02103218|182842505|SUPERIORITY|||||||0.02||||||Omnibus overall test for any group x time interaction was p = 0.77.|linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.02
91484323|NCT02103218|182842506|SUPERIORITY|||||||0.67|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.67
91484324|NCT02103218|182842507|SUPERIORITY|||||||0.45|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.45
91484325|NCT02103218|182842508|SUPERIORITY|||||||0.7|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
91484326|NCT02103218|182842509|SUPERIORITY|||||||0.42|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.42
91484327|NCT02103218|182842510|SUPERIORITY|||||||0.63|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.63
91484328|NCT02103218|182842511|SUPERIORITY|||||||0.05||||||Omnibus overall test for any group x time interaction was p = 0.78.|count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.05
91484329|NCT02103218|182842512|SUPERIORITY|||||||0.5|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.50
91484330|NCT02103218|182842514|SUPERIORITY|||||||0.86|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.86
91484331|NCT02103218|182842515|SUPERIORITY|||||||0.46|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.46
91525804|NCT03587142|182927118|SUPERIORITY||Incident rate ratio|1.27||||0.64|TWO_SIDED|95.0|0.57|2.82||P values are nominal and not adjusted for multiple comparisons.|Exact poisson regression|||Event rates are computed by treatment arm by dividing the total adverse events over 4-weeks by the number of patient-months of follow-up to 4-weeks. Event rates are compared by treatment arm using an exact poisson regression for event rates.||2.82|0.57|0.64
91632732|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.89||0.068|TWO_SIDED|95.0|-3.4|0.12||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||0.12|-3.40|0.068
91666885|NCT01634139|183227626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|0.111||0.0709|TWO_SIDED|95.0|-0.419|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.017|-0.419|0.0709
91484332|NCT02103218|182842516|SUPERIORITY|||||||0.7|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
91632733|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.52||0.051|TWO_SIDED|95.0|-2.04|0.0||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.00|-2.04|0.051
91632734|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.52||0.212|TWO_SIDED|95.0|-1.68|0.38||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.38|-1.68|0.212
91714348|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.261||0.3389||95.0|-0.26|0.76|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.26|0.3389
91632735|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-9.3|-2.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||-2.04|-9.30|0.002
91632736|NCT02711553|183158529|SUPERIORITY||LS Mean Difference|-3.42|STANDARD_ERROR_OF_MEAN|1.85||0.066|TWO_SIDED|95.0|-7.07|0.22||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||0.22|-7.07|0.066
91632737|NCT03399786|183158544|SUPERIORITY||Least Squares (LS) Mean Difference|-49.0|STANDARD_ERROR_OF_MEAN|8.0|<|0.0001|TWO_SIDED|95.0|-65.0|-33.1|||Mixed-effect Model Repeat Measure (MMRM)|||Confidence interval (CI) with p-value was based on-treatment group difference of least squares (LS) means using mixed-effect model repeat measurement (MMRM), randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-33.1|-65.0|< 0.0001
91632738|NCT03399786|183158545|SUPERIORITY||Least Squares (LS) Mean Difference|-36.9|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-48.6|-25.2|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated Apo B value.||-25.2|-48.6|< 0.0001
91632739|NCT03399786|183158546|SUPERIORITY||Least Squares (LS) Mean Difference|-51.7|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|-64.8|-38.5|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated non-HDL-C value.||-38.5|-64.8|< 0.0001
91632740|NCT03399786|183158547|SUPERIORITY||Least Squares (LS) Mean Difference|-48.4|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-58.7|-38.1|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated TC value.||-38.1|-58.7|< 0.0001
91632741|NCT03399786|183158548|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|25.2|||<|0.0001|TWO_SIDED|95.0|5.7|110.5|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||110.5|5.7|< 0.0001
91666886|NCT01634139|183227627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.065||0.0749|TWO_SIDED|95.0|-0.245|0.012|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.012|-0.245|0.0749
91666887|NCT01634139|183227627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.065||0.0305|TWO_SIDED|95.0|-0.269|-0.013|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.013|-0.269|0.0305
91714349|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.254||0.5079||95.0|-0.33|0.67|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.67|-0.33|0.5079
91714350|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.265||0.0453||95.0|0.01|1.05|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.01|0.0453
91666888|NCT01634139|183227627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.125|STANDARD_ERROR_OF_MEAN|0.066||0.0581|TWO_SIDED|95.0|-0.255|0.004|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.004|-0.255|0.0581
91666889|NCT01634139|183227627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131|STANDARD_ERROR_OF_MEAN|0.066||0.0464|TWO_SIDED|95.0|-0.26|-0.002|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||-0.002|-0.260|0.0464
91666890|NCT01634139|183227628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096|STANDARD_ERROR_OF_MEAN|0.062||0.1182|TWO_SIDED|95.0|-0.217|0.025|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.025|-0.217|0.1182
91666891|NCT01634139|183227628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.126|STANDARD_ERROR_OF_MEAN|0.061||0.0404|TWO_SIDED|95.0|-0.246|-0.006|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.006|-0.246|0.0404
91666892|NCT01634139|183227628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.099|STANDARD_ERROR_OF_MEAN|0.062||0.1105|TWO_SIDED|95.0|-0.221|0.023|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.023|-0.221|0.1105
91666893|NCT01634139|183227628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.103|STANDARD_ERROR_OF_MEAN|0.062||0.0983|TWO_SIDED|95.0|-0.224|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.019|-0.224|0.0983
91666894|NCT01634139|183227629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.507|STANDARD_ERROR_OF_MEAN|5.387||0.1146|TWO_SIDED|95.0|-2.063|19.077|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||19.077|-2.063|0.1146
91666895|NCT01634139|183227629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.493|STANDARD_ERROR_OF_MEAN|5.365||0.1628|TWO_SIDED|95.0|-3.034|18.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||18.020|-3.034|0.1628
91792451|NCT02554279|183462651|NON_INFERIORITY|The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin.|Absolute difference|4.7|||||TWO_SIDED|95.0|-2.7|12.1||||||Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%.||12.1|-2.7|
91484333|NCT02103218|182842517|SUPERIORITY|||||||0.29|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
91632742|NCT03399786|183158549|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|24.2|||=|0.0028|TWO_SIDED|95.0|3.0|195.6|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||195.6|3.0|= 0.0028
91632743|NCT03399786|183158550|SUPERIORITY||Least Squares (LS) Mean Difference|-132.1|STANDARD_ERROR_OF_MEAN|21.5|<|0.0001|TWO_SIDED|95.0|-175.3|-88.9|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-88.9|-175.3|< 0.0001
91632744|NCT03399786|183158551|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0845|TWO_SIDED|95.0|0.0|1.3|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||1.3|0|= 0.0845
91632745|NCT03399786|183158552|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|5.7|||=|0.0203|TWO_SIDED|95.0|1.3|24.9||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||24.9|1.3|= 0.0203
91666896|NCT01634139|183227629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.538|STANDARD_ERROR_OF_MEAN|5.435||0.3085|TWO_SIDED|95.0|-5.127|16.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||16.203|-5.127|0.3085
91666897|NCT01634139|183227629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.774|STANDARD_ERROR_OF_MEAN|5.413||0.1053|TWO_SIDED|95.0|-1.847|19.394|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||19.394|-1.847|0.1053
91666898|NCT01634139|183227630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.36|STANDARD_ERROR_OF_MEAN|5.451||0.0236|TWO_SIDED|95.0|1.663|23.056|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||23.056|1.663|0.0236
91666899|NCT01634139|183227630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.146|STANDARD_ERROR_OF_MEAN|5.427||0.0093|TWO_SIDED|95.0|3.497|24.794|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||24.794|3.497|0.0093
91666900|NCT01634139|183227630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.882|STANDARD_ERROR_OF_MEAN|5.497||0.7322|TWO_SIDED|95.0|-12.667|8.904|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||8.904|-12.667|0.7322
91792452|NCT02554279|183462652|OTHER||Absolute difference|1.2|||||TWO_SIDED|95.0|-6.6|8.9||||||||8.9|-6.6|
91792453|NCT02554279|183462653|OTHER||Absolute difference|3.8|||||TWO_SIDED|95.0|-3.8|11.3||||||||11.3|-3.8|
91792454|NCT02554279|183462654|OTHER||Absolute difference|-9.5|||||TWO_SIDED|95.0|-19.2|0.2||||||||0.2|-19.2|
91792455|NCT00998764|183462674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.324|TWO_SIDED|95.0|-0.74|2.23|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13||2.23|-0.74|0.324
91632746|NCT03399786|183158553|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0004|TWO_SIDED|95.0|0.0|0.3||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analysis|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||0.3|0.0|= 0.0004
91632747|NCT01928186|183158582|OTHER|||||||0.51|||||||Fisher Exact|the mid-P adjustment to Fisher's exact test||Association between response assessed by Ki-67 protein staining (i.e. \< 10% positive cells in the surgical sample) and by the influx constant Ki decline (i.e. 30 % or larger decline between the baseline and post-therapy FLT PET) was analyzed using the mid-P adjustment to Fisher's exact test.||||0.51
91632748|NCT04540627|183158596|SUPERIORITY|||||||0.5802|||||||Wilcoxon (Mann-Whitney)|||||||0.5802
91632749|NCT04540627|183158597|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
91632750|NCT04540627|183158598|SUPERIORITY|||||||0.2681|||||||Wilcoxon (Mann-Whitney)|||||||0.2681
91632751|NCT04540627|183158599|SUPERIORITY|||||||0.2431|||||||Wilcoxon (Mann-Whitney)|||||||0.2431
91632752|NCT04540627|183158604|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
91632753|NCT04540627|183158606|SUPERIORITY|||||||0.0403|||||||Wilcoxon (Mann-Whitney)|||||||0.0403
91632754|NCT00211536|183158652|NON_INFERIORITY_OR_EQUIVALENCE|For the average A1C, the goal was to show non-inferiority of MIP compared to SC. The minimal clinically relevant increase in A1C (%) was set at 0.50%. The between-subjects standard deviation of A1C was assumed to be 1.0% based on previous studies.|Least square means|0.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|ONE_SIDED|95.0||0.5|||Mixed Models Analysis|Repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed to compare A1C trends over time between the treatment groups||Sample size calculations were performed on the primary endpoint: the average glycosylated hemoglobin (A1C). Sample size was estimated using a two-sample, one-sided t-test with a significance level of 0.05. The projected sample size of 50 subjects per treatment group provides 79% power to reject the null hypothesis in favor of the alternative hypothesis that the average A1C in both the MIP and SC groups are equivalent, assuming an effect size of 0.50% and a standard deviation of 1.0%.||0.5||<0.05
91632755|NCT00805194|183158683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0019|TWO_SIDED|95.0|0.68|0.92|||Regression, Cox||Hazard Ratio (HR) below 1 favors nintedanib|HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||0.92|0.68|0.0019
91632756|NCT00805194|183158684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0073|TWO_SIDED|95.0|0.6|0.92||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma and \<9 months since start of first line therapy."||0.92|0.60|0.0073
91666901|NCT01634139|183227630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.176|STANDARD_ERROR_OF_MEAN|5.481||0.4463|TWO_SIDED|95.0|-6.578|14.929|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||14.929|-6.578|0.4463
91632757|NCT00805194|183158684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0359|TWO_SIDED|95.0|0.7|0.99||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma."||0.99|0.70|0.0359
91632758|NCT00805194|183158684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.272|TWO_SIDED|95.0|0.83|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for all patients."||1.05|0.83|0.2720
91632759|NCT00805194|183158685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.007|TWO_SIDED|95.0|0.75|0.96||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.96|0.75|0.0070
91666902|NCT01634139|183227631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.262|STANDARD_ERROR_OF_MEAN|1.039||0.8008|TWO_SIDED|95.0|-1.775|2.299|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||2.299|-1.775|0.8008
91666903|NCT01634139|183227631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|1.041||0.8731|TWO_SIDED|95.0|-1.875|2.208|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||2.208|-1.875|0.8731
91666904|NCT01634139|183227631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.058||0.7975|TWO_SIDED|95.0|-1.803|2.346|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||2.346|-1.803|0.7975
91666905|NCT01634139|183227631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.579|STANDARD_ERROR_OF_MEAN|1.059||0.5845|TWO_SIDED|95.0|-2.656|1.498|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||1.498|-2.656|0.5845
91666906|NCT01634139|183227632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.048||0.6932|TWO_SIDED|95.0|-0.075|0.113|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.113|-0.075|0.6932
91666907|NCT01634139|183227632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.048||0.1741|TWO_SIDED|95.0|-0.158|0.029|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.029|-0.158|0.1741
91666908|NCT01634139|183227632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.048||0.625|TWO_SIDED|95.0|-0.071|0.118|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.118|-0.071|0.6250
91666909|NCT01634139|183227632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.048||0.7597|TWO_SIDED|95.0|-0.109|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.080|-0.109|0.7597
91484334|NCT02103218|182842518|SUPERIORITY|||||||0.43|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.43
91666910|NCT01634139|183227633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.05||0.6166|TWO_SIDED|95.0|-0.122|0.073|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.073|-0.122|0.6166
91666911|NCT01634139|183227633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076|STANDARD_ERROR_OF_MEAN|0.049||0.1267|TWO_SIDED|95.0|-0.173|0.021|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.021|-0.173|0.1267
91666912|NCT01634139|183227633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0|-0.092|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.105|-0.092|0.9000
91666913|NCT01634139|183227633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.05||0.3897|TWO_SIDED|95.0|-0.141|0.055|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.055|-0.141|0.3897
91666914|NCT01634139|183227634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.072||0.0975|TWO_SIDED|95.0|-0.262|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.022|-0.262|0.0975
91666915|NCT01634139|183227634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_ERROR_OF_MEAN|0.072||0.0116|TWO_SIDED|95.0|-0.323|-0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.041|-0.323|0.0116
91666916|NCT01634139|183227634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.073||0.3732|TWO_SIDED|95.0|-0.208|0.078|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.078|-0.208|0.3732
91666917|NCT01634139|183227634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.073||0.1985|TWO_SIDED|95.0|-0.236|0.049|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.049|-0.236|0.1985
91666918|NCT01634139|183227636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.072||0.0144|TWO_SIDED|95.0|0.035|0.316|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.316|0.035|0.0144
91666919|NCT01634139|183227636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.071||0.0747|TWO_SIDED|95.0|-0.013|0.267|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.267|-0.013|0.0747
91666920|NCT01634139|183227636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.072||0.7654|TWO_SIDED|95.0|-0.163|0.12|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.120|-0.163|0.7654
91666921|NCT01634139|183227636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.072||0.8082|TWO_SIDED|95.0|-0.124|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.158|-0.124|0.8082
91666922|NCT01634139|183227637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.085||0.0392|TWO_SIDED|95.0|0.009|0.341|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.341|0.009|0.0392
91666923|NCT01634139|183227637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.084||0.1351|TWO_SIDED|95.0|-0.039|0.292|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.292|-0.039|0.1351
91666924|NCT01634139|183227637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.085||0.8291|TWO_SIDED|95.0|-0.185|0.149|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.149|-0.185|0.8291
91666925|NCT01634139|183227637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.085||0.9655|TWO_SIDED|95.0|-0.163|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.171|-0.163|0.9655
91666926|NCT01634139|183227638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.191|STANDARD_ERROR_OF_MEAN|0.077||0.0139|TWO_SIDED|95.0|0.039|0.343|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.343|0.039|0.0139
91666927|NCT01634139|183227638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.077||0.1043|TWO_SIDED|95.0|-0.026|0.276|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.276|-0.026|0.1043
91666928|NCT01634139|183227638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.078||0.6547|TWO_SIDED|95.0|-0.118|0.187|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.187|-0.118|0.6547
91666929|NCT01634139|183227638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.077||0.3648|TWO_SIDED|95.0|-0.082|0.222|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.222|-0.082|0.3648
91714351|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.256||0.1622||95.0|-0.15|0.86|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.86|-0.15|0.1622
91714352|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.262||0.0003||95.0|0.45|1.48|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.48|0.45|0.0003
91714353|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0383||95.0|0.03|1.05|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.03|0.0383
91714354|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.253||0.4495||95.0|-0.31|0.69|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.69|-0.31|0.4495
91484335|NCT02443519|182842521|SUPERIORITY||Slope|1.6||||0.027|TWO_SIDED|95.0|-0.7|3.9||Significance threshold set a priori at .025 to adjust for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates greater reduction in the proportino of people with Severe MIDAS scores (Score \>=21) in the MBCT-M group vs. the WL/TAU group.|||3.9|-0.7|.027
91792456|NCT00998764|183462674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.723|TWO_SIDED|95.0|-1.33|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26||1.92|-1.33|0.723
91792457|NCT00998764|183462674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.966|TWO_SIDED|95.0|-1.81|1.89|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39||1.89|-1.81|0.966
91666930|NCT01634139|183227639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|0.074||0.0256|TWO_SIDED|95.0|0.02|0.312|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.312|0.020|0.0256
91666931|NCT01634139|183227639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.074||0.0561|TWO_SIDED|95.0|-0.004|0.286|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.286|-0.004|0.0561
91666932|NCT01634139|183227639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.075||0.4127|TWO_SIDED|95.0|-0.208|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.085|-0.208|0.4127
91666933|NCT01634139|183227639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.8922|TWO_SIDED|95.0|-0.136|0.156|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.156|-0.136|0.8922
91666934|NCT01634139|183227641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.7931|TWO_SIDED|95.0|-0.08|0.061|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.061|-0.080|0.7931
91666935|NCT01634139|183227641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.036||0.0369|TWO_SIDED|95.0|-0.145|-0.005|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.005|-0.145|0.0369
91666936|NCT01634139|183227641|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.036||0.4086|TWO_SIDED|95.0|-0.101|0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.041|-0.101|0.4086
91666937|NCT01634139|183227641|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.036||0.4714|TWO_SIDED|95.0|-0.097|0.045|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.045|-0.097|0.4714
91792458|NCT00998764|183462674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-1.93|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52||1.92|-1.93|0.996
91792459|NCT00998764|183462674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.336|TWO_SIDED|95.0|-3.67|1.26|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78||1.26|-3.67|0.336
91632760|NCT00805194|183158686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0012|TWO_SIDED|95.0|0.73|0.93||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.93|0.73|0.0012
91632761|NCT00805194|183158687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3067|TWO_SIDED|95.0|0.76|2.39||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.39|0.76|0.3067
91632762|NCT00805194|183158687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0761|TWO_SIDED|95.0|0.96|2.08||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||2.08|0.96|0.0761
91632763|NCT00805194|183158690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.0|1.35|2.09||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.09|1.35|<0.0001
91632764|NCT00805194|183158690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.31|2.05||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||2.05|1.31|<0.0001
91632765|NCT00805194|183158692|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||<0.0001
91632766|NCT00805194|183158692|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||<0.0001
91632767|NCT00805194|183158693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7282|TWO_SIDED|95.0|0.87|1.21||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||1.21|0.87|0.7282
91632768|NCT00805194|183158694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1858|TWO_SIDED|95.0|0.77|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough||1.05|0.77|0.1858
91632769|NCT00805194|183158694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.5203|TWO_SIDED|95.0|0.91|1.2||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea||1.20|0.91|0.5203
91632770|NCT00805194|183158694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4373|TWO_SIDED|95.0|0.82|1.09||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain||1.09|0.82|0.4373
91632771|NCT02530281|183158735|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91632772|NCT02530281|183158736|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
91666938|NCT01634139|183227642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.047||0.988|TWO_SIDED|95.0|-0.091|0.092|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.092|-0.091|0.9880
91666939|NCT01634139|183227642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.082|STANDARD_ERROR_OF_MEAN|0.046||0.0794|TWO_SIDED|95.0|-0.173|0.01|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.010|-0.173|0.0794
91632773|NCT02530281|183158737|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
91632774|NCT02530281|183158738|OTHER||||||=|0.001|||||||ANCOVA|Ranked ANCOVA||||||=0.001
91632775|NCT02530281|183158739|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91632776|NCT02530281|183158740|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91632777|NCT00535236|183158744|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||<0.001
91632778|NCT00535236|183158744|OTHER|||||||0.003||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.003
91632779|NCT00535236|183158744|OTHER|||||||0.017||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.017
91632780|NCT00535236|183158745|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjustied for prevaccination values||||||<0.001
91666940|NCT01634139|183227642|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.053|STANDARD_ERROR_OF_MEAN|0.047||0.2623|TWO_SIDED|95.0|-0.145|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.040|-0.145|0.2623
91666941|NCT01634139|183227642|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.047||0.3552|TWO_SIDED|95.0|-0.136|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.040|-0.136|0.3552
91714355|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.263||0.0135||95.0|0.14|1.17|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0135
91714356|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.254||0.1423||95.0|-0.13|0.87|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.87|-0.13|0.1423
91714357|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.259||0.0035||95.0|0.25|1.27|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.27|0.25|0.0035
91714358|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.261||0.0125||95.0|0.14|1.17|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0125
91714359|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.254||0.8021||95.0|-0.44|0.56|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.44|0.8021
91484336|NCT02443519|182842522|SUPERIORITY||Slope|14.1|||<|0.004|TWO_SIDED|95.0|0.8|21.8||Significance threshold set a priori at .025 to account for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|Positive slope indicated larger reductions in HDI in the MBCT-M group compared to the WL/TAU group.|||21.8|0.8|<.004
91632781|NCT00535236|183158745|OTHER|||||||0.004||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.004
91632782|NCT00535236|183158745|OTHER|||||||0.026||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.026
91632783|NCT00535236|183158746|OTHER||Difference in Percentages|12.5|||||TWO_SIDED|95.0|-21.7|35.3|||||V212 minus placebo = Difference|||35.3|-21.7|
91632784|NCT00535236|183158746|OTHER||Difference in Percentages|10.0|||||TWO_SIDED|95.0|-15.1|42.9|||||V212 minus placebo = Difference|||42.9|-15.1|
91632785|NCT00535236|183158746|OTHER||Difference in Percentages|1.8|||||TWO_SIDED|95.0|-20.4|15.7|||||V212 minus placebo = Difference|||15.7|-20.4|
91632786|NCT00535236|183158746|OTHER||Difference in Percentages|14.4|||||TWO_SIDED|95.0|-6.5|27.6|||||V212 minus placebo = Difference|||27.6|-6.5|
91632787|NCT00535236|183158746|OTHER||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-18.1|17.0|||||V212 minus placebo = Difference|||17.0|-18.1|
91632788|NCT00535236|183158747|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-31.7|16.5|||Asymptotic method||V212 minus placebo = Difference|||16.5|-31.7|>0.999
91632789|NCT00535236|183158747|OTHER||Difference in Percentages|10.0||||0.302|TWO_SIDED|95.0|-18.8|23.2|||Asymptotic method||V212 minus placebo = Difference|||23.2|-18.8|0.302
91632790|NCT00535236|183158747|OTHER||Difference in Percentages|31.6||||0.009|TWO_SIDED|95.0|9.7|46.2|||Asymptotic method||V212 minus placebo = Difference|||46.2|9.7|0.009
91632791|NCT00535236|183158747|OTHER||Difference in Percentages|22.6||||0.041|TWO_SIDED|95.0|1.3|36.6|||Asymptotic method||V212 minus placebo = Difference|||36.6|1.3|0.041
91632792|NCT00535236|183158747|OTHER||Difference in Percentages|-11.7||||0.064|TWO_SIDED|95.0|-33.2|0.6|||Asymptotic method||V212 minus placebo = Difference|||0.6|-33.2|0.064
91632793|NCT00535236|183158748|OTHER||Difference in Percentages|-5.0||||0.556|TWO_SIDED|95.0|-36.3|9.5|||Asymptotic method||V212 minus placebo = Difference|||9.5|-36.3|0.556
91632794|NCT00535236|183158748|OTHER||Difference in Percentages|2.5||||0.617|TWO_SIDED|95.0|-25.8|13.0|||Asymptotic method||V212 minus placebo = Difference|||13.0|-25.8|0.617
91632795|NCT00535236|183158748|OTHER||Difference in Percentages|3.5||||0.411|TWO_SIDED|95.0|-13.7|12.0|||Asymptotic method||V212 minus placebo = Difference|||12.0|-13.7|0.411
91632796|NCT00535236|183158748|OTHER||Difference in Percentages|4.9||||0.328|TWO_SIDED|95.0|-12.3|13.6|||Asymptotic method||V212 minus placebo = Difference|||13.6|-12.3|0.328
91632797|NCT00535236|183158748|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-19.2|10.0|||Asymptotic method||V212 minus placebo = Difference|||10.0|-19.2|>0.999
91632798|NCT00535236|183158749|OTHER||Difference in Percentages|10.5||||0.552|TWO_SIDED|95.0|-21.3|41.8|||Asymptotic method||V212 minus placebo = Difference|||41.8|-21.3|0.552
91632799|NCT00535236|183158749|OTHER||Difference in Percentages|6.7||||0.696|TWO_SIDED|95.0|-22.5|39.4|||Asymptotic method||V212 minus placebo = Difference|||39.4|-22.5|0.696
91632800|NCT00535236|183158749|OTHER||Difference in Percentages|7.5||||0.221|TWO_SIDED|95.0|-9.8|18.0|||Asymptotic method||V212 minus placebo = Difference|||18.0|-9.8|0.221
91632801|NCT00535236|183158749|OTHER||Difference in Percentages|6.8||||0.402|TWO_SIDED|95.0|-13.7|19.1|||Asymptotic method||V212 minus placebo = Difference|||19.1|-13.7|0.402
91632802|NCT00535236|183158749|OTHER||Difference in Percentages|3.8||||0.679|TWO_SIDED|95.0|-18.5|18.2|||Asymptotic method||V212 minus placebo = Difference|||18.2|-18.5|0.679
91484337|NCT02443519|182842523|SUPERIORITY||Slope|-0.05||||0.773|TWO_SIDED|95.0|-3.7|2.8||Threshold for statistical significance set a priori at .05.|Mixed Models Analysis|Key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with Treatment and Time in the model|A positive slope indicates greater reduction in headache days in the MBCT-M group vs. the WL/TAU group.|||2.8|-3.7|.773
91714360|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.267||0.0249||95.0|0.08|1.13|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.13|0.08|0.0249
91714361|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3383||95.0|-0.26|0.75|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.75|-0.26|0.3383
91792460|NCT00998764|183462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.737|TWO_SIDED|95.0|-1.11|0.79|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 13||0.79|-1.11|0.737
91484338|NCT02443519|182842524|SUPERIORITY||Slope|0.01||||0.888|TWO_SIDED|95.0|-0.14|0.16||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in headache attack pain intensity in the MBCT-M group vs. WL/TAU.|||0.16|-0.14|.888
91632803|NCT04167514|183158773|SUPERIORITY||Odds Ratio (OR)|1.92||||0.034|TWO_SIDED|95.0|0.954|3.866|||One-sided Wald|One-sided Wald test of superior odds of overall response under AAT treatment compared to placebo.Threshold of significance at \<0.025.|Wald CIs|||3.866|0.954|0.034
91632804|NCT01766401|183158874|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0438|TWO_SIDED|95.0|-2.96|-0.04|||MMRM|||||-0.04|-2.96|0.0438
91632805|NCT01766401|183158875|SUPERIORITY||Least Squares Mean Difference|-1.41||||0.0868|TWO_SIDED|95.0|-3.02|0.2|||MMRM|||||0.20|-3.02|0.0868
91632806|NCT00886587|183158876|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.04||||0.9416|TWO_SIDED|95.0|-1.09|1.17||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.17|-1.09|0.9416
91632807|NCT00886587|183158877|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.35||||0.5431|TWO_SIDED|95.0|-0.78|1.48||The significance level threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.48|-0.78|0.5431
91632808|NCT00886587|183158878|SUPERIORITY_OR_OTHER||Estimated Mean Difference|-0.06||||0.788|TWO_SIDED|95.0|-0.47|0.36||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment as a factor, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.36|-0.47|0.788
91632809|NCT00886587|183158879|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.03||||0.9508|TWO_SIDED|95.0|-0.9|0.96||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-0.90|0.9508
91632810|NCT01523613|183158880|SUPERIORITY|||||||0.262|||||||Fisher Exact|||||||0.262
91632811|NCT01523613|183158881|SUPERIORITY|||||||0.523|||||||Fisher Exact|||||||0.523
91632812|NCT01523613|183158882|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.100
91632813|NCT01108068|183158883|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype T-test was used to compare differences at baseline between affecteds and unaffecteds||||||0.0003|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Cortical area Z-score||||0.0003
91632814|NCT01108068|183158883|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype||||||0.001|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Periosteal circumference Z-score||||0.001
91632815|NCT00696774|183158894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.005|TWO_SIDED|95.0|-1.12|-0.2|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.20|-1.12|0.005
91632816|NCT00696774|183158896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-7.34|-4.36|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-4.36|-7.34|
91632817|NCT00696774|183158897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-3.13|-1.81|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.81|-3.13|
91632818|NCT00696774|183158898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.29|||||TWO_SIDED|95.0|-4.1|-2.48|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.48|-4.10|
91632819|NCT00696774|183158899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|||||TWO_SIDED|95.0|-2.89|-1.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.54|-2.89|
91792461|NCT00998764|183462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.213|TWO_SIDED|95.0|-1.76|0.4|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 26||0.40|-1.76|0.213
91484339|NCT02443519|182842525|SUPERIORITY||Slope|7.45||||0.035|TWO_SIDED|95.0|2.48|12.42|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Pain Catastrophizing Scale in the MBCT-M group vs. WL/TAU.|||12.42|2.48|.035
91632820|NCT00696774|183158900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-2.45|-1.3|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.30|-2.45|
91632821|NCT00696774|183158901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-1.31|-0.63|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.63|-1.31|
91632822|NCT00696774|183158902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42|||||TWO_SIDED|95.0|-6.04|-2.8|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.80|-6.04|
91632823|NCT00696774|183158903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.42|-0.84|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.84|-1.42|
91632824|NCT00696774|183158904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-1.08|-0.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.24|-1.08|
91632825|NCT00696774|183158905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.81|-0.18|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.18|-0.81|
91632826|NCT00696774|183158906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||||TWO_SIDED|95.0|-0.99|2.6|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||2.60|-0.99|
91632827|NCT00696774|183158906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.69|3.42|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||3.42|-0.69|
91632828|NCT00696774|183158907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.05|||||TWO_SIDED|95.0|10.63|19.47|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||19.47|10.63|
91632829|NCT00696774|183158907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.48|||||TWO_SIDED|95.0|4.72|16.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||16.24|4.72|
91632830|NCT00696774|183158908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||||TWO_SIDED|95.0|-7.75|-4.02|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||-4.02|-7.75|
91632831|NCT00696774|183158908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|||||TWO_SIDED|95.0|-6.65|-2.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||-2.54|-6.65|
91484340|NCT02443519|182842526|SUPERIORITY||Slope|-3.05||||0.572|TWO_SIDED|95.0|-10.83|4.74|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Chronic Pain Acceptance in the MBCT-M group vs. WL/TAU.|||4.74|-10.83|.572
91632832|NCT00033293|183158911|OTHER||Chi-squared test statistic|8.125||||0.0044|TWO_SIDED|95.0||||No adjustments for multiple comparisons.|Chi-squared|A two-way test with a null hypothesis of no association, using SAS 9.4.||"The 5 categories of OMA ratings are: stance, gait, arm \& hand function, opsoclonus, \& mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the best of 3 time points: 2 months, 6 months \& 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test."||||0.0044
91632833|NCT00033293|183158912|OTHER||Mean Difference (Net)|60.1979||||0.0919|ONE_SIDED||||||t-test, 1 sided|||The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.||||0.0919
91632834|NCT00033293|183158913|OTHER|The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|Mean Difference (Net)|16.75||||0.2364|ONE_SIDED||||||t-test, 1 sided|||||||0.2364
91792462|NCT00998764|183462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.168|TWO_SIDED|95.0|-2.19|0.38|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 39||0.38|-2.19|0.168
91792463|NCT00998764|183462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.197|TWO_SIDED|95.0|-2.3|0.48|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 52||0.48|-2.30|0.197
91792464|NCT00998764|183462675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.044|TWO_SIDED|95.0|-4.21|0.06|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 78||0.06|-4.21|0.044
91632835|NCT00935701|183158919|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Restless-Impulsive subscale||||0.01
91632836|NCT00935701|183158919|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Emotional Lability subscale||||0.09
91632837|NCT00935701|183158919|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Global Index Total||||0.02
91632838|NCT00935701|183158919|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Inattentive subscale||||0.01
91632839|NCT00935701|183158919|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Hyperactive-Impulsive subscale||||0.03
91632840|NCT00935701|183158919|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Total||||0.01
91632841|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Bedtime Resistance subscale||||0.08
91632842|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Onset Delay subscale||||0.03
91632843|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Duration subscale||||0.82
91632844|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Anxiety subscale||||0.58
91632845|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Night Wakings subscale||||0.66
91632846|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parasomnias subscale||||0.18
91632847|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Daytime Sleepiness subscale||||0.31
91632848|NCT00935701|183158920|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Disturbance||||0.07
91632849|NCT00935701|183158921|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Child Domain Total||||0.04
91632850|NCT00935701|183158921|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parent Domain Total||||0.31
91632851|NCT00935701|183158921|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Stress||||0.07
91632852|NCT00572728|183158965|SUPERIORITY_OR_OTHER||AUC|0.68|STANDARD_ERROR_OF_MEAN|0.1||0.046|ONE_SIDED|95.0||0.83||The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one-sided p value DeLong ER, DeLong DM, Clarke-Pearson DL, Biometrics (1988)|Delong method|one-sided p-value|"percent change in SUVmax was computed as: %ΔSUVmax = 100\*(FLT1-FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.~Hanley SE(AUC) reported."|"A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC \>= 0.75 AUC = ROC(%ΔSUVmax\| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100"||.83||0.046
91632853|NCT00572728|183158966|SUPERIORITY_OR_OTHER||spearman correlation|0.35||||0.002|TWO_SIDED|95.0|0.13|0.54|||spearman correlation method||This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic||0.54|0.13|0.002
91632854|NCT00572728|183158967|SUPERIORITY_OR_OTHER||Spearman Correlation|0.67|||<|0.0001|TWO_SIDED|95.0|0.47|0.81|||Spearman Correlation method|we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI||0.81|0.47|<0.0001
91632855|NCT00572728|183158968|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||"H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups.."||||0.66
91632856|NCT00572728|183158969|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|\*two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.||||0.86
91632857|NCT00572728|183158970|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.||||0.010
91632858|NCT00572728|183158970|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.013|TWO_SIDED|95.0|0.76|0.97|||Regression, Logistic|||H0: %SUVmax FLT1-FLT3 (RCB 0,I) = %SUVmax FLT1-FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.||0.97|0.76|0.013
91632859|NCT00572728|183158971|SUPERIORITY_OR_OTHER||AUC|0.83|||<|0.001|TWO_SIDED|90.0|0.72|0.94||Delong 1-sided p-value (alpha=0.05)|Delong Method|The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC||"ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1-FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1-FLT3\|pCR)= 1 - P(%ΔSUVmax FLT1-FLT3\|non-pCR) that is: H0: AUC =0.5 (guessing)"||.94|.72|<0.001
91632860|NCT00572728|183158972|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Kruskal-Wallis|two-sided p value from Kruskal-Wallis one-way ANOVA||"Kruskal-Wallis one-way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status."||||0.86
91632861|NCT00572728|183158973|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||two-sided p value from Kruskal-Wallis one-way ANOVA|Kruskal-Wallis|||||||0.67
91714362|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.26||0.0001||95.0|0.55|1.57|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.57|0.55|0.0001
91714363|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.261||0.0133||95.0|0.14|1.17|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0133
91714364|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.256||0.382||95.0|-0.28|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-0.28|0.3820
91666942|NCT01634139|183227643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.049||0.4359|TWO_SIDED|95.0|-0.135|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.058|-0.135|0.4359
91666943|NCT01634139|183227643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.049||0.2293|TWO_SIDED|95.0|-0.155|0.037|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.037|-0.155|0.2293
91666944|NCT01634139|183227643|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8372|TWO_SIDED|95.0|-0.108|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.088|-0.108|0.8372
91714365|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.269||0.0053||95.0|0.23|1.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.28|0.23|0.0053
91714366|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3258||95.0|-0.25|0.76|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.25|0.3258
91714367|NCT00676403|183320243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.0005||95.0|0.41|1.43|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.43|0.41|0.0005
91714368|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1429||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1429
91792465|NCT00998764|183462676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.077|TWO_SIDED|95.0|-6.3|0.33|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 13||0.33|-6.30|0.077
91666945|NCT01634139|183227643|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.049||0.3022|TWO_SIDED|95.0|-0.148|0.046|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.046|-0.148|0.3022
91527830|NCT06173570|182930687|SUPERIORITY||Mean Difference (Net)|-38.66|||<|0.001|TWO_SIDED|95.0|-46.9|-30.43|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-30.43|-46.90|< 0.001
91666946|NCT01634139|183227644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.046||0.5004|TWO_SIDED|95.0|-0.122|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.060|-0.122|0.5004
91666947|NCT01634139|183227644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.046||0.1982|TWO_SIDED|95.0|-0.149|0.031|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.031|-0.149|0.1982
91666948|NCT01634139|183227644|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.8019|TWO_SIDED|95.0|-0.103|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.103|0.8019
91792466|NCT00998764|183462676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.117|TWO_SIDED|95.0|-6.02|0.67|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 26||0.67|-6.02|0.117
91792467|NCT00998764|183462676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.063|TWO_SIDED|95.0|-7.38|0.19|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 39||0.19|-7.38|0.063
91792468|NCT00998764|183462676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.412|TWO_SIDED|95.0|-5.95|2.44|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 52||2.44|-5.95|0.412
91792469|NCT00998764|183462676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78||||0.321|TWO_SIDED|95.0|-8.28|2.73|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 78||2.73|-8.28|0.321
91484341|NCT02443519|182842527|SUPERIORITY||Slope|-2.65||||0.609|TWO_SIDED|95.0|-11.76|6.46||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a smaller decrease in the Five Factor Mindfulness Questionnaire in the MBCT-M group vs. WL/TAU.|||6.46|-11.76|.609
91484342|NCT02443519|182842528|SUPERIORITY||Slope|8.45||||0.022|TWO_SIDED|95.0|2.99|13.91||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Headache Specific Locus of Control Scale score in the MBCT-M group vs. WL/TAU.|||13.91|2.99|.022
91484343|NCT02443519|182842529|SUPERIORITY||Slope|-2.01||||0.124|TWO_SIDED|95.0|-7.56|3.53||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Headache Management Self-Efficacy Scale score in the MBCT-M group vs. WL/TAU.|||3.53|-7.56|.124
91484344|NCT02443519|182842530|SUPERIORITY||Slope|3.48||||0.017|TWO_SIDED|95.0|0.63|6.33||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Depression score in the MBCT-M group vs. WL/TAU.|||6.33|0.63|.017
91525805|NCT03587142|182927119|SUPERIORITY||Incident rate ratio|0.95||||0.54|TWO_SIDED|95.0|0.35|2.62||P values are nominal.|Fisher Exact|||A Fisher's Exact test was used for comparisons of events by treatment by severity grade. One patient in the Buspirone arm had 2 AEs during the trial; for analysis by severity grade the maximum severity grade was used.|An exact poisson regression stratified by severity level was used to compute the incident rate ratio and 95% Confidence Intervals for adverse events by severity level.|2.62|0.35|0.54
91525806|NCT03587142|182927120|SUPERIORITY|||||||1||||||P value is nominal.|Fisher Exact|||||||1.00
91632862|NCT00679380|183158974|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|3.8||||0.2876|TWO_SIDED|95.0|-3.0|10.5|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Entocort EC and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Entocort EC versus budesonide MMX.||10.5|-3.0|0.2876
91632863|NCT00679380|183158974|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|12.9||||0.0047|TWO_SIDED|95.0|4.6|21.3|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||21.3|4.6|0.0047
91632864|NCT00679380|183158974|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.1||||0.0481|TWO_SIDED|95.0|0.4|15.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||15.9|0.4|0.0481
91632865|NCT00679380|183158975|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-8.0||||0.2174|TWO_SIDED|95.0|-20.8||||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||4.|-20.8|0.2174
91632866|NCT00679380|183158975|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.2215|TWO_SIDED|95.0|-5.0|22.0|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||22.0|-5.0|0.2215
91632867|NCT00679380|183158975|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-0.7||||0.9185|TWO_SIDED|95.0|-14.1|12.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.7|-14.1|0.9185
91632868|NCT00679380|183158976|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.4||||0.4293|TWO_SIDED|95.0|-8.0|18.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Entocort EC and placebo groups is shown here.||18.8|-8.0|0.4293
91632869|NCT00678249|183158983|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91632870|NCT04337203|183158994|OTHER|Feasibility study and calculated confidence interval.||||||0.54|||||||Independent samples proportions test|||||||0.54
91666949|NCT01634139|183227644|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.046||0.4872|TWO_SIDED|95.0|-0.123|0.059|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.059|-0.123|0.4872
91666950|NCT01634139|183227645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3498|TWO_SIDED|95.0|-0.135|0.048|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.048|-0.135|0.3498
91632871|NCT03049852|183159025|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91632872|NCT03049852|183159027|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
91666951|NCT01634139|183227645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.046||0.0222|TWO_SIDED|95.0|-0.196|-0.015|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.015|-0.196|0.0222
91632873|NCT02141854|183159028|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.179||||0.0009|TWO_SIDED|95.0|0.074|0.285||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.285|0.074|0.0009
91632874|NCT02141854|183159028|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.182||||0.001|TWO_SIDED|95.0|0.074|0.291||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.291|0.074|0.0010
91632875|NCT02141854|183159028|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.326||||0|TWO_SIDED|95.0|0.221|0.431||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.431|0.221|0.0000
91632876|NCT02141854|183159028|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.322||||0|TWO_SIDED|95.0|0.212|0.432||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.432|0.212|0.0000
91632877|NCT02141854|183159029|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.276||||0|TWO_SIDED|95.0|0.191|0.361||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.361|0.191|0.0000
91632878|NCT02141854|183159029|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.274||||0|TWO_SIDED|95.0|0.189|0.36||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.189|0.0000
91632879|NCT02141854|183159029|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.183||||0|TWO_SIDED|95.0|0.098|0.268||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.268|0.098|0.0000
91666952|NCT01634139|183227645|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.799|TWO_SIDED|95.0|-0.104|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.104|0.7990
91666953|NCT01634139|183227645|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.035|STANDARD_ERROR_OF_MEAN|0.047||0.4586|TWO_SIDED|95.0|-0.126|0.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.057|-0.126|0.4586
91666954|NCT01634139|183227646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.056||0.4221|TWO_SIDED|95.0|-0.156|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.065|-0.156|0.4221
91484345|NCT02443519|182842531|SUPERIORITY||Slope|2.82||||0.259|TWO_SIDED|95.0|-0.03|5.68||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Anxiety score in the MBCT-M group vs. WL/TAU.|||5.68|-0.03|.259
91632880|NCT02141854|183159029|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.123||||0.0047|TWO_SIDED|95.0|0.038|0.208||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.208|0.038|0.0047
91632881|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|18.45||||0|TWO_SIDED|95.0|11.751|25.15||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||25.150|11.751|0.0000
91666955|NCT01634139|183227646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.056||0.0959|TWO_SIDED|95.0|-0.204|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.017|-0.204|0.0959
91666956|NCT01634139|183227646|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.057||0.9627|TWO_SIDED|95.0|-0.109|0.114|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.114|-0.109|0.9627
91484346|NCT02443519|182842532|SUPERIORITY||Slope|-1.0||||0.007|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with both Treatment and Time in the model.|A negative slope indicated a larger decrease in MIDI scores in the MBCT-M group vs. WL/TAU|||-0.3|-1.6|.007
91666957|NCT01634139|183227646|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.057||0.3457|TWO_SIDED|95.0|-0.165|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.058|-0.165|0.3457
91666958|NCT01634139|183227647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.043||0.3375|TWO_SIDED|95.0|-0.043|0.125|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.125|-0.043|0.3375
91666959|NCT01634139|183227647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.043||0.388|TWO_SIDED|95.0|-0.047|0.121|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.121|-0.047|0.3880
91666960|NCT01634139|183227647|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.043||0.6541|TWO_SIDED|95.0|-0.066|0.104|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.104|-0.066|0.6541
91666961|NCT01634139|183227647|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.043||0.5089|TWO_SIDED|95.0|-0.056|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.056|0.5089
91484347|NCT03635788|182842546|SUPERIORITY|The study had approximately 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of regimen failure|Cumulative probability difference|-18.4|||||TWO_SIDED|98.4|-32.4|-4.3|||||Treatment difference was calculated as LA-ART minus SOC. 98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of regimen failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-4.3|-32.4|
91484348|NCT03635788|182842547|SUPERIORITY|The study had at least 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of virologic failure|cumulative probability difference|-21.4|||||TWO_SIDED|98.4|-33.5|-9.3|||||Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of virologic failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-9.3|-33.5|
91632882|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|16.718||||0|TWO_SIDED|95.0|9.988|23.449||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||23.449|9.988|0.0000
91632883|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|31.221||||0|TWO_SIDED|95.0|24.513|37.93||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||37.930|24.513|0.0000
91666962|NCT02627963|183227661|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0165|TWO_SIDED|95.0|0.56|0.94||A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.|Log Rank|||||0.94|0.56|0.0165
91666963|NCT02627963|183227662|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8174|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||||1.25|0.75|0.8174
91666964|NCT03068780|183227746|SUPERIORITY||Odds Ratio (OR)|1.84||||0.013|TWO_SIDED|95.0|1.02|3.3||P-value adjusted with CHW method using CMH test statistics based on a test stratified by EB subtype and target wound size class estimated separately before and after the interim analysis for sample size re-estimation.Threshold of superiority p\<0.05.|Cui, Hung, Wang (CHW) approach|Primary efficacy endpoint was first assessed with the CMH test, but the final statistical analysis was performed based on the CHW approach.|The CMH test statistic from the data until the interim analysis (IA) and the CMH test statistic of the data after the IA must be calculated separately. The results are then combined using the CHW weighted approach to one test-statistic.|||3.30|1.02|0.013
91666965|NCT03068780|183227747|SUPERIORITY|||||||0.302||||||Threshold of superiority is p\<0.05|Chi-squared|||||||0.302
91666966|NCT00840658|183227793|SUPERIORITY|||||||0.036|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)|To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.036
91692039|NCT02174627|183278569|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.26|||<|0.001|TWO_SIDED|95.0|0.23|0.31|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.31|0.23|<0.001
91714369|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0547||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0547
91792470|NCT00998764|183462677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.329|TWO_SIDED|95.0|-3.24|1.09|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 13||1.09|-3.24|0.329
91792471|NCT00998764|183462677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.601|TWO_SIDED|95.0|-3.31|1.92|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 26||1.92|-3.31|0.601
91632884|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|29.597||||0|TWO_SIDED|95.0|22.839|36.354||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||36.354|22.839|0.0000
91792472|NCT00998764|183462677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.328|TWO_SIDED|95.0|-4.67|1.56|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 39||1.56|-4.67|0.328
91792473|NCT00998764|183462677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.68|TWO_SIDED|95.0|-2.7|4.13|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 52||4.13|-2.70|0.680
91484349|NCT03635788|182842548|SUPERIORITY||cumulative probability diffeence|-19.2|||||TWO_SIDED|98.4|-31.6|-6.9||||||Treatment comparison was conducted by cumulative probability of treatment-related failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.|Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|-6.9|-31.6|
91632885|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.771||||0.0002|TWO_SIDED|95.0|6.179|19.363||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.363|6.179|0.0002
91632886|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.879||||0.0002|TWO_SIDED|95.0|6.216|19.541||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.541|6.216|0.0002
91632887|NCT02141854|183159030|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|11.146||||0.001|TWO_SIDED|95.0|4.511|17.782||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||17.782|4.511|0.0010
91666967|NCT00840658|183227794|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)|We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.013
91666968|NCT05109104|183227805|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
91666969|NCT05109104|183227805|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
91666970|NCT05109104|183227805|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|27.0|||||TWO_SIDED|||||||||||||
91792474|NCT00998764|183462677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.954|TWO_SIDED|95.0|-5.05|4.77|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 78||4.77|-5.05|0.954
91792475|NCT00998764|183462678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.931|TWO_SIDED|95.0|-2.4|2.62|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 26.||2.62|-2.40|0.931
91792476|NCT00998764|183462678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.524|TWO_SIDED|95.0|-3.26|1.67|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 52.||1.67|-3.26|0.524
91792477|NCT00998764|183462678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.353|TWO_SIDED|95.0|-6.32|2.27|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 78.||2.27|-6.32|0.353
91792478|NCT00998764|183462679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.531|TWO_SIDED|95.0|-2.92|1.51|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 26.||1.51|-2.92|0.531
91792479|NCT00998764|183462679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.137|TWO_SIDED|95.0|-4.28|0.59|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 52.||0.59|-4.28|0.137
91792480|NCT00998764|183462679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.128|TWO_SIDED|95.0|-7.6|0.96|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 78.||0.96|-7.60|0.128
91714370|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.0095||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0095
91632888|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.156||||0.001|TWO_SIDED|95.0|-0.248|-0.063||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.063|-0.248|0.0010
91632889|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.195||||0|TWO_SIDED|95.0|-0.288|-0.102||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.102|-0.288|0.0000
91632890|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.304||||0|TWO_SIDED|95.0|-0.397|-0.212||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.212|-0.397|0.0000
91632891|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.277||||0|TWO_SIDED|95.0|-0.37|-0.184||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.184|-0.370|0.0000
91632892|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.149||||0.0014|TWO_SIDED|95.0|-0.239|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.239|0.0014
91632893|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.082||||0.0818|TWO_SIDED|95.0|-0.174|0.01||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.010|-0.174|0.0818
91632894|NCT02141854|183159031|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.121||||0.0094|TWO_SIDED|95.0|-0.213|-0.03||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.030|-0.213|0.0094
91632895|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.702||||0|TWO_SIDED|95.0|-1.001|-0.403||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.403|-1.001|0.0000
91632896|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.607||||0.0001|TWO_SIDED|95.0|-0.908|-0.307||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.307|-0.908|0.0001
91632897|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.066||||0|TWO_SIDED|95.0|-1.365|-0.766||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.766|-1.365|0.0000
91666971|NCT00834561|183227848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.14||||||90.0|99.99|108.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.47|99.99|
91666972|NCT00834561|183227849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.07||||||90.0|101.33|106.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.89|101.33|
91666973|NCT00834561|183227850|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.68||||||90.0|101.42|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.00|101.42|
91484350|NCT03635788|182842549|SUPERIORITY|The proportions of participants with HIV-1 RNA ≥ 50 copies/ml was compared by Fisher's Exact Test.|Mean Difference (Final Values)|-21.8|||<|0.001|TWO_SIDED|95.0|-35.6|-8.1|||Fisher Exact||||Treatment difference in the proportions of participants with HIV-1 RNA ≥ 50 copies/ml was calculated as LA-ART minus SOC.|-8.1|-35.6|<0.001
91792481|NCT00998764|183462680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.811|TWO_SIDED|95.0|-0.49|0.63|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 6.||0.63|-0.49|0.811
91484351|NCT03635788|182842550|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-36.1|-12.8|||Fisher Exact||Difference in the proportions of participants with HIV-1 RNA ≥ 200 copies was calculated as LA-ART minus SOC.|The proportions of participants with HIV-1 RNA ≥ 200 copies/ml was compared by Fisher's Exact Test.||-12.8|-36.1|<0.001
91484352|NCT03635788|182842555|SUPERIORITY||Cumulative probability difference|-8.4|||||TWO_SIDED|98.4|-21.3|4.5|||||Treatment difference in cumulative of permanent treatment discontinuation was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of permanent treatment discontinuation in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||4.5|-21.3|
91632898|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.989||||0|TWO_SIDED|95.0|-1.291|-0.686||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.686|-1.291|0.0000
91632899|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.364||||0.016|TWO_SIDED|95.0|-0.659|-0.068||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.068|-0.659|0.0160
91632900|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.382||||0.0124|TWO_SIDED|95.0|-0.681|-0.083||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.083|-0.681|0.0124
91632901|NCT02141854|183159032|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.287||||0.0588|TWO_SIDED|95.0|-0.584|0.011||Significance level of 0.05.|Wilcoxon (Mann-Whitney)|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.011|-0.584|0.0588
91632902|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Significance level of 0.05.|Log Rank|||||||0.0001
91632903|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
91666974|NCT00672984|183227858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43||||||90.0|-4.52|-0.34||||||||-0.34|-4.52|
91666975|NCT00672984|183227858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.87||||||90.0|11.45|16.29||||||||16.29|11.45|
91666976|NCT00672984|183227859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.08||||||90.0|-11.37|-4.78||||||||-4.78|-11.37|
91666977|NCT00672984|183227859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.13||||||90.0|9.33|16.93||||||||16.93|9.33|
91666978|NCT00672984|183227860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||||90.0|-1.07|3.03||||||||3.03|-1.07|
91666979|NCT00672984|183227860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.11||||||90.0|8.97|13.24||||||||13.24|8.97|
91666980|NCT00672984|183227861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64||||||90.0|-0.99|4.27||||||||4.27|-0.99|
91484353|NCT05595382|182842566|SUPERIORITY|Repeated measures of likelihood to enroll (on a 1 to 7 scale with higher numbers indicating a greater likelihood) pre/post intervention||||||0.001|||||||ANOVA|Degrees of freedom (1, 359)||||||.001
91632904|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||Significance level of 0.05.|Log Rank|||||||0.0003
91632905|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
91666981|NCT00672984|183227861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8||||||90.0|7.63|13.97||||||||13.97|7.63|
91666982|NCT00672984|183227862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.76||||||90.0|-8.01|-5.51||||||||-5.51|-8.01|
91632906|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7203||||||Significance level of 0.05.|Log Rank|||||||0.7203
91632907|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.996||||||Significance level of 0.05.|Log Rank|||||||0.9960
91666983|NCT00672984|183227862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73||||||90.0|3.08|6.38||||||||6.38|3.08|
91666984|NCT00672984|183227863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.85||||||90.0|-21.92|-17.78||||||||-17.78|-21.92|
91666985|NCT00672984|183227863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44||||||90.0|1.77|5.11||||||||5.11|1.77|
91666986|NCT00672984|183227864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.32||||||90.0|11.75|18.89||||||||18.89|11.75|
91666987|NCT00672984|183227864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||||90.0|-2.77|4.63||||||||4.63|-2.77|
91666988|NCT00672984|183227865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|49.85||||||90.0|44.71|54.98||||||||54.98|44.71|
91666989|NCT00672984|183227865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.63||||||90.0|-0.41|7.66||||||||7.66|-0.41|
91792482|NCT00998764|183462680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.681|TWO_SIDED|95.0|-0.45|0.69|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 19.||0.69|-0.45|0.681
91792483|NCT00998764|183462680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.742|TWO_SIDED|95.0|-0.51|0.72|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||0.72|-0.51|0.742
91792484|NCT00998764|183462680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.598|TWO_SIDED|95.0|-0.48|0.83|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||0.83|-0.48|0.598
91632908|NCT02141854|183159033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||||||Significance level of 0.05.|Log Rank|||||||0.3250
91792485|NCT00998764|183462680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.922|TWO_SIDED|95.0|-0.85|0.77|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||0.77|-0.85|0.922
91632909|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.269|0.677||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.677|0.269|0.0000
91632910|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.428||||0|TWO_SIDED|95.0|0.224|0.632||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.632|0.224|0.0000
91632911|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.623||||0|TWO_SIDED|95.0|0.418|0.828||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.828|0.418|0.0000
91632912|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.681||||0|TWO_SIDED|95.0|0.478|0.885||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.885|0.478|0.0000
91632913|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.15||||0.149|TWO_SIDED|95.0|-0.054|0.354||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.354|-0.054|0.1490
91632914|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0143|TWO_SIDED|95.0|0.051|0.455||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.455|0.051|0.0143
91632915|NCT02141854|183159034|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.209||||0.0435|TWO_SIDED|95.0|0.006|0.411||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.411|0.006|0.0435
91632916|NCT01868594|183159037|SUPERIORITY|||||||0.019||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.019
91632917|NCT01868594|183159038|SUPERIORITY|||||||0.0432||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0432
91632918|NCT01868594|183159039|SUPERIORITY|||||||0.7344||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.7344
91632919|NCT01868594|183159040|SUPERIORITY|||||||0.278||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.2780
91632920|NCT01868594|183159040|SUPERIORITY|||||||0.8114||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.8114
91792486|NCT00998764|183462681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 6.||0.90|-0.08|0.099
91632921|NCT01868594|183159040|SUPERIORITY|||||||0.1619||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.1619
91632922|NCT01868594|183159040|SUPERIORITY|||||||0.0764||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.0764
91632923|NCT01868594|183159041|SUPERIORITY|||||||0.3107||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3107
91792487|NCT00998764|183462681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.089|TWO_SIDED|95.0|-0.07|1.01|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 19.||1.01|-0.07|0.089
91792488|NCT00998764|183462681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.152|TWO_SIDED|95.0|-0.17|1.08|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||1.08|-0.17|0.152
91632924|NCT01868594|183159041|SUPERIORITY|||||||0.5236||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.5236
91632925|NCT01868594|183159041|SUPERIORITY|||||||0.3847||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3847
91632926|NCT01868594|183159042|SUPERIORITY|||||||0.6716|||||||t-test, 2 sided|||||||0.6716
91632927|NCT01868594|183159043|SUPERIORITY|||||||0.2484||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.||||0.2484
91632928|NCT01868594|183159043|SUPERIORITY|||||||0.761||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hyperglycaemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.7610
91632929|NCT01868594|183159043|SUPERIORITY|||||||0.3714||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hypoglycemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.3714
91632930|NCT02598661|183159057|SUPERIORITY||Percentage Difference|24.8|||<|0.001|TWO_SIDED|95.0|9.9|36.89||The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\[vs.\]\>6 units RBC) \& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||36.89|9.90|<0.001
91632931|NCT02598661|183159059|SUPERIORITY||Percentage Difference|24.6|||<|0.001|TWO_SIDED|95.0|12.64|34.18||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||34.18|12.64|<0.001
91632932|NCT02598661|183159062|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.105|0.586||The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.|Log Rank||Hazard ratio and 95% CI were calculated using the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||0.586|0.105|<0.001
91632933|NCT02598661|183159063|SUPERIORITY||Percentage Difference|11.9||||0.112|TWO_SIDED|95.0|-4.1|27.56||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||95% CI was calculated based on the Wilson Score Method.|||27.56|-4.10|0.112
91632934|NCT02598661|183159066|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.526|1.823||P value (two-sided) for superiority of imetelstat sodium versus placebo in hazard ratio was calculated using stratified log-rank test.|Log Rank||Hazard ratio and 95% CI were calculated from the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||1.823|0.526|0.949
91632935|NCT00848172|183159084|SUPERIORITY_OR_OTHER||||||=|0.345||95.0|||||Mixed Models Analysis|||||||=0.345
91692040|NCT02174627|183278570|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.3|0.44|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.44|0.30|<0.001
91792489|NCT00998764|183462681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.16|TWO_SIDED|95.0|-0.21|1.25|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||1.25|-0.21|0.160
91632936|NCT00848172|183159085|SUPERIORITY_OR_OTHER||||||=|0.031||95.0|||||Mixed Models Analysis|||||||=0.031
91632937|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0901|||TWO_SIDED|90.0|-0.087|0.211|||mixed model repeated measures|||Week 12||0.211|-0.087|
91632938|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.084|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|-0.066|0.234|||mixed model repeated measures|||Week 12||0.234|-0.066|
91632939|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|90.0|-0.102|0.294|||mixed model repeated measures|||Week 24||0.294|-0.102|
91792490|NCT00998764|183462681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.603|TWO_SIDED|95.0|-0.73|1.26|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||1.26|-0.73|0.603
91632940|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.205|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|0.007|0.404|||mixed model repeated measures|||Week 24||0.404|0.007|
91632941|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.2135|||TWO_SIDED|90.0|-0.155|0.55|||mixed model repeated measures|||Week 36||0.550|-0.155|
91632942|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.423|STANDARD_ERROR_OF_MEAN|0.2152|||TWO_SIDED|90.0|0.068|0.779|||mixed model repeated measures|||Week 36||0.779|0.068|
91632943|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.2644|||TWO_SIDED|90.0|-0.385|0.489|||mixed model repeated measures|||Week 48||0.489|-0.385|
91632944|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.2662|||TWO_SIDED|90.0|0.049|0.928|||mixed model repeated measures|||Week 48||0.928|0.049|
91632945|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.3361|||TWO_SIDED|90.0|-0.248|0.862|||mixed model repeated measures|||Week 72||0.862|-0.248|
91632946|NCT04566445|183159103|SUPERIORITY||LS Mean Difference|0.503|STANDARD_ERROR_OF_MEAN|0.3392|||TWO_SIDED|90.0|-0.058|1.063|||mixed model repeated measures|||Week 72||1.063|-0.058|
91632947|NCT04566445|183159104|SUPERIORITY||LS Mean Difference|0.645|STANDARD_ERROR_OF_MEAN|0.4527|||TWO_SIDED|90.0|-0.103|1.393|||mixed model repeated measures|||Week 96||1.393|-0.103|
91525807|NCT03587142|182927121|SUPERIORITY||Incident rate ratio|1.03||||1|TWO_SIDED|95.0|0.0|40.36||P-values are nominal.|Exact poisson regression|||Event rates were computed by dividing the number of hospitalizations over 4-weeks by the number of person-years. An exact poisson regression was used to compare events by treatment group.||40.36|0|1.00
91632948|NCT04566445|183159104|SUPERIORITY||LS Mean Difference|0.838|STANDARD_ERROR_OF_MEAN|0.4577|||TWO_SIDED|90.0|0.081|1.594|||mixed model repeated measures|||Week 96||1.594|0.081|
91632949|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-2.6|1.7|||mixed model repeated measures|||Week 12||1.7|-2.6|
91632950|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-4.0|0.4|||mixed model repeated measures|||Week 12||0.4|-4.0|
91632951|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-4.1|0.8|||mixed model repeated measures|||Week 24||0.8|-4.1|
91632952|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-7.7|-2.8|||mixed model repeated measures|||Week 24||-2.8|-7.7|
91632953|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-2.5|3.5|||mixed model repeated measures|||Week 36||3.5|-2.5|
91632954|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-7.7|-1.7|||mixed model repeated measures|||Week 36||-1.7|-7.7|
91632955|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|90.0|-0.9|6.1|||mixed model repeated measures|||Week 48||6.1|-0.9|
91632956|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-5.6|1.4|||mixed model repeated measures|||Week 48||1.4|-5.6|
91632957|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|90.0|1.0|8.4|||mixed model repeated measures|||Week 72||8.4|1.0|
91632958|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|90.0|-2.8|4.5|||mixed model repeated measures|||Week 72||4.5|-2.8|
91632959|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|90.0|2.7|11.6|||mixed model repeated measures|||Week 96||11.6|2.7|
91632960|NCT04566445|183159109|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-1.8|7.1|||mixed model repeated measures|||Week 96||7.1|-1.8|
91632961|NCT04453722|183159114|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.12|TWO_SIDED|95.0|-0.4|0.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital TWA SpO2 \<90% (%)||0|-0.4|0.120
91632962|NCT04453722|183159114|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test|Median Difference (Final Values)|-407.0||||0.349|TWO_SIDED|95.0|-1816.0|208.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital AUC SpO2 \<90% (% \* min)||208|-1816|0.349
91632963|NCT04453722|183159114|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.2|0.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge TWA SpO2 \<90% (%)||0|-0.2|0.307
91632964|NCT04453722|183159114|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-35.0||||0.431|TWO_SIDED|95.0|-195.0|67.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge AUC SpO2 \<90% (% \* min)||67|-195|0.431
91632965|NCT04453722|183159115|SUPERIORITY||Risk Ratio (RR)|0.96|||>|0.99|TWO_SIDED|95.0|0.22|4.27|||Fisher Exact|||variable: In hospital Any event, N (%)c||4.27|0.22|>0.99
91632966|NCT04453722|183159115|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.35|2.9|||Chi-squared|||variable: Post-discharge Any event, N (%)||2.90|0.35|>0.99
91632967|NCT04453722|183159116|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-6.0||||0.354|TWO_SIDED|95.0|-26.0|4.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital Number||4.0|-26.0|0.354
91632968|NCT04453722|183159116|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-46.1||||0.133|TWO_SIDED|95.0|-274.0|5.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Total duration (min)||5.1|-274|0.133
91632969|NCT04453722|183159116|SUPERIORITY||Median Difference (Final Values)|-24.1||||0.075|TWO_SIDED|95.0|-213.0|0.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Duration \>2 min (min)||0.1|-213|0.075
91632970|NCT04453722|183159116|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.009|TWO_SIDED|95.0|-4.5|-0.4|||Wilcoxon (Mann-Whitney)|||variable: In hospital Mean duration-all patients (min)||-0.4|-4.5|0.009
91632971|NCT04453722|183159116|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.001|TWO_SIDED|95.0|-4.7|-0.7|||Wilcoxon (Mann-Whitney)|||variable: in hospital mean duration for events in those with any events (min)||-0.7|-4.7|0.001
91632972|NCT04453722|183159116|SUPERIORITY||Median Difference (Final Values)|0.0||||0.584|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: post-discharge number||1.0|-4.0|0.584
91632973|NCT04453722|183159116|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-1.3||||0.556|TWO_SIDED|95.0|-18.6|3.3|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge duration (min)||3.3|-18.6|0.556
91632974|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.096|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (at the day of discharge)||2.0|0.0|0.096
91632975|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.205|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing sleep (at the day of discharge)||2.0|0.0|0.205
91484354|NCT05595382|182842567|SUPERIORITY|||||||0.357|||||||ANOVA|Degrees of freedom (1, 358)||Repeated measures ANOVA comparing mood (rated on a 1-10 scale with higher scores indicating better mood) given to participants before and after the study manipulation by group||||.357
91666990|NCT00270634|183227877|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|-3.2|||||ONE_SIDED|95.0||1.3|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|The 6-month BPAR rate was used to calculate an estimate of the difference in rates between each VCS group and TAC, combining across pooled investigative center strata, weighted by the number of patients in each of the pooled center strata. The overall standard error was estimated for the linear combination of proportions. Using this statistic and its standard error, the upper bound one-sided 95% C.I. was constructed for the difference in BPAR rates between groups (VCS - TAC).||1.3||
91666991|NCT00270634|183227877|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.6|||||ONE_SIDED|95.0||10.8|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||10.8||
91666992|NCT00270634|183227877|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.9|||||ONE_SIDED|95.0||11.4|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||11.4||
91692041|NCT02174627|183278571|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.283||0.12|TWO_SIDED|95.0|-0.11|0.99|||Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||0.99|-0.11|0.120
91632976|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.839|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: comfortable to wear (at the day of discharge)||0.0|-1.0|0.839
91632977|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.621|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (at the day of discharge)||0.0|0.0|0.621
91632978|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert||1.0|-1.0|0.898
91632979|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.654|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: easily cleaned/disinfected (at the day of discharge)||0.0|0.0|0.654
91632980|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.929|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: adequate battery life (at the day of discharge)||1.0|-1.0|0.929
91632981|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch (at the day of discharge)||0.0|-1.0|0.200
91632982|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.987|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (at the day of discharge)||0.0|0.0|0.987
91484355|NCT05595382|182842568|SUPERIORITY|||||||0.102|||||||ANOVA|||||||.102
91632983|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line (at the day of discharge)||0.0|-1.0|0.581
91525808|NCT03587142|182927122|SUPERIORITY|||||||0.52||||||Nominal P value.|Binomial probability test|2-sided test with probability of success=0||||||0.52
91525809|NCT02294630|182927132|OTHER|||||||0.399|||||||t-test, 2 sided|||||||0.399
91632984|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.18|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (after 24 hours of discharge)||3.0|0.0|0.180
91666993|NCT00573313|183227885|SUPERIORITY_OR_OTHER||Ratio of Geometric Means at 24 weeks.|0.1505|STANDARD_ERROR_OF_MEAN|0.1615||0.36|TWO_SIDED|95.0|-0.1853|0.4863||The data provided here are for changes in serum AST levels as representative of all clinical laboratory parameters measured.|ANCOVA|Analysis of covariance controlled for baseline data, e.g. AST.|Obtained median values and ranges and log transformations of SD.|Power calculation indicated that a sample size of 20 subjects per treatment arm would detect differences between groups of 0.9 within-subject standard deviations or higher at 80% power and 5% level of significance.||0.4863|-0.1853|0.36
91666994|NCT00835588|183227886|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|88.8||||||90.0|82.7|95.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.4|82.7|
91666995|NCT00835588|183227887|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|93.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|93.4|
91666996|NCT00835588|183227888|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|91.6|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|91.6|
91666997|NCT01597791|183227906|SUPERIORITY|||||||0.05||||||Calculated.|Fisher Exact|||||||.05
91666998|NCT00354159|183227913|SUPERIORITY_OR_OTHER||6-month survival rate|90.5|||<|0.001|ONE_SIDED|97.5|87.7|||The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard \[e.g. log survival estimate\] for the variance.|Survival estimate at 6-months|The survival estimate at 6-months post-implant was compared to 80%.||"Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%."|||87.7|<0.001
91666999|NCT00354159|183227915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.978|TWO_SIDED|95.0|0.61|1.61||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.~Null Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different."||1.61|0.61|0.978
91667000|NCT00354159|183227916|SUPERIORITY_OR_OTHER|||||||0.574||95.0|||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)~where mu is the percentage of hospitalized days for heart failure."||||0.574
91667001|NCT00354159|183227917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.527|TWO_SIDED|95.0|0.62|1.28||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill Model||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different."||1.28|0.62|0.527
91667002|NCT00354159|183227918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.505|TWO_SIDED|95.0|0.57|1.32|||Regression, Cox|The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.|Hazard Ratio is for the Treatment Arm relative to the Control Arm|"Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.~Alternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm."||1.32|0.57|0.505
91667003|NCT00354159|183227919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.088|TWO_SIDED|95.0|0.56|1.04|||Andersen-Gill Model|The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The all cause event rate between the treatment arm and control arm is different."||1.04|0.56|0.088
91484356|NCT03722173|182842569|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|141.62|STANDARD_ERROR_OF_MEAN|13.3|||TWO_SIDED|90.0|129.64|154.71|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the geometric means (gMeans) (T/R) for AUC0-tz and their 2-sided 90% confidence intervals (CIs) were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||154.71|129.64|
91667004|NCT00354159|183227920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.758|TWO_SIDED|95.0|0.73|1.54||P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.|Proportional odds model||Odds ratio represents the odds of improved score in the treatment group relative to the control group.|"Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.~Alternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm."||1.54|0.73|0.758
91667005|NCT00354159|183227923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.599|TWO_SIDED|95.0|0.29|2.06|||Regression, Cox|The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model|Hazard ratio estimates the hazard of death in the treatment group relative to the control group.|"Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.~Alternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups."||2.06|0.29|0.599
91667006|NCT00354159|183227924|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Negative-Binomial Regression|||The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.||||0.145
91667007|NCT00354159|183227925|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||t-test, 2 sided|||"Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.~Alternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms."||||0.033
91667008|NCT00354159|183227926|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||"Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.~Alternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period."||||0.002
91667009|NCT00354159|183227927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.292|TWO_SIDED|95.0|0.82|1.96|||Proportional odds regression model||Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.|"Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.~Alternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms."||1.96|0.82|0.292
91714371|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3676||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3676
91714372|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2959||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2959
91714373|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3435||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3435
91714374|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0895||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0895
91714375|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0844||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0844
91714376|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0675||95.0|-1.1|0.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.1|0.0675
91714377|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.225||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.2250
91667010|NCT00354159|183227928|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.~Alternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms."||||0.996
91667011|NCT00354159|183227929|SUPERIORITY_OR_OTHER|||||||0.154||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.~Alternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm."||||0.154
91667012|NCT00354159|183227932|SUPERIORITY_OR_OTHER|||||||0.583||95.0|||||Mixed Models Analysis|Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.||"Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.~Alternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm."||||0.583
91714378|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3728||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3728
91525810|NCT02567825|182927151|SUPERIORITY||Risk Ratio (RR)|0.97||||0.66|TWO_SIDED|95.0|0.84|1.12|||Generalized linear model|The p-value is adjusted for site, age at enrollment, and exposure or nonexposure to other children.|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2-year follow-up period.||1.12|0.84|0.66
91632985|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.171|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: degree of distributing sleep (after 24 hours of discharge)||2.0|0.0|0.171
91632986|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.074|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (after 24 hours of discharge)||0.0|-1.0|0.074
91632987|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert (after 24 hours of discharge)||1.0|-2.0|0.414
91632988|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.506|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Easily cleaned/disinfected (after 24 hours of discharge)||0.0|0.0|0.506
91632989|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.747|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life (after 24 hours of discharge)||0.0|-1.0|0.747
91667013|NCT00354159|183227933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.48||||0.368|TWO_SIDED|95.0|0.63|3.5||The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.|Andersen-Gill Model|Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.||"Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.~Alternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm."||3.5|0.63|0.368
91667014|NCT01451541|183227989|SUPERIORITY_OR_OTHER||LS Means with adjusted pvalues|0.59|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
91632990|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|-1.0||||0.023|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: satisfy with the electrode patch (after 24 hours of discharge)||0.0|-2.0|0.023
91632991|NCT04453722|183159119|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.023|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (after 24 hours of discharge)||0.0|-1.0|0.023
91632992|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.73|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Degree of disturbing routine work||0.0|-1.0|0.73
91632993|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.097|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||Easily cleaned/disinfected||1.0|0.0|0.097
91632994|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|1.0||||0.02|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life||1.0|0.0|0.02
91632995|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.037|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch||1.0|0.0|0.037
91632996|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.482|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert||1.0|-2.0|0.482
91632997|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study||1.0|0.0|0.031
91632998|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.947|TWO_SIDED|95.0|0.0|1.0||variable: Patients' complaint about the device|Wilcoxon (Mann-Whitney)|||variable: Patients' complaint about the device||1.0|0.0|0.947
91632999|NCT04453722|183159120|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.324|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line||0.0|0.0|0.324
91484357|NCT03722173|182842570|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|113.32|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|102.47|125.32|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for Cmax and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||125.32|102.47|
91633000|NCT00137267|183159121|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91633001|NCT00137267|183159122|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Chi-squared|||||||0.152
91633002|NCT02061540|183159147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.841|STANDARD_ERROR_OF_MEAN|6.0373||0.0043|TWO_SIDED|95.0|-27.251|-2.432|||Wilcoxon's signed rank test|||Analysis was performed to compare baseline and endpoint data.||-2.432|-27.251|0.0043
91633003|NCT01948518|183159152|SUPERIORITY_OR_OTHER||||||=|0.3|TWO_SIDED||||||t-test, 2 sided|||Assuming 15% change in absolute value of DLCO representing a significant clinical difference and a standard deviation of 17.4% in normal nonsmoking individuals \[Miller A, Thornton JC, Warshaw R, et al. Am Rev Respir Dis. 1983;127 (suppl 3):270-277.\], 13 subjects needed to be studied to reject the null hypothesis when there is no significant difference between DLCO measurements before and after sildenafil, with power 0.8 and type I error probability 0.05 (SAS 9.2, SAS Institute Inc., Cary, NC)||||=0.30
91633004|NCT01948518|183159153|SUPERIORITY_OR_OTHER||||||=|0.63|||||||t-test, 2 sided|||The average 6 minute walk distance at baseline was 1195±407 feet. After oral administration of sildenafil, 6 minute walk distance was 1214±383 feet (p=0.63).||||=0.63
91633005|NCT00958191|183159219|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 1 year||||<0.0001
91633006|NCT00958191|183159219|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 3 years||||<0.0001
91667015|NCT01451541|183227989|SUPERIORITY_OR_OTHER||LS Means with adjusted p-values.|0.47|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
91667016|NCT00006436|183228020|SUPERIORITY|||||||0.1|||||||Two-tailed log rank test||||Compared the PFS of interim PET positive participants to the PFS of interim PET negative.|||0.10
91527831|NCT06173570|182930687|SUPERIORITY||Mean Difference (Net)|-45.18|||<|0.001|TWO_SIDED|95.0|-53.43|-36.94|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-36.94|-53.43|< 0.001
91633007|NCT00958191|183159219|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in HHS from pre-op to 5 years||||<0.0001
91633008|NCT00958191|183159220|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 1 year||||<0.0001
91633009|NCT00958191|183159220|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 3 years||||<0.0001
91633010|NCT00958191|183159220|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 5 years||||<0.0001
91633011|NCT00958191|183159221|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 1 year||||<0.0001
91633012|NCT00958191|183159221|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 3 years||||<0.0001
91633013|NCT00958191|183159221|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 5 years||||<0.0001
91633014|NCT00958191|183159222|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 1 year||||<0.0001
91633015|NCT00958191|183159222|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Phyiscal Component Score from preop to 3 year||||<0.0001
91633016|NCT00958191|183159222|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 5 year||||<0.0001
91633017|NCT00958191|183159222|SUPERIORITY_OR_OTHER|||||||0.0242|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 1 year||||0.0242
91633018|NCT00958191|183159222|SUPERIORITY_OR_OTHER|||||||0.0247|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 3 year||||0.0247
91633019|NCT00958191|183159222|SUPERIORITY_OR_OTHER|||||||0.1372|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 5 year||||0.1372
91633020|NCT00958191|183159223|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 1 year||||<0.0001
91633021|NCT00958191|183159223|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 3 year||||<0.0001
91633022|NCT00958191|183159223|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in LEAS Score from preop to 5 year||||<0.0001
91633023|NCT01642004|183159225|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.0002|TWO_SIDED|96.85|0.43|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel|||0.81|0.43|0.0002
91633024|NCT00598806|183159239|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1094|TWO_SIDED|95.0|0.55|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.55|0.1094
91633025|NCT00598806|183159240|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1038|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.1038
91633026|NCT01714336|183159288|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Regression, Logistic|||||||0.75
91484358|NCT03722173|182842571|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|142.54|STANDARD_ERROR_OF_MEAN|13.5|||TWO_SIDED|90.0|130.3|155.93|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for AUC0-∞ and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||155.93|130.30|
91633027|NCT01021553|183159300|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.16||||0.4959|TWO_SIDED|95.0|0.75|1.79|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.79|0.75|0.4959
91633028|NCT01021553|183159300|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.11||||0.6161|TWO_SIDED|95.0|0.74|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.74|0.6161
91633029|NCT01021553|183159300|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.13||||0.4971|TWO_SIDED|95.0|0.79|1.61|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.61|0.79|0.4971
91633030|NCT01021553|183159301|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.9037|TWO_SIDED|95.0|0.67|1.58|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.58|0.67|0.9037
91633031|NCT01021553|183159301|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.0||||0.9939|TWO_SIDED|95.0|0.67|1.48|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.48|0.67|0.9939
91633032|NCT01021553|183159301|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.01||||0.9541|TWO_SIDED|95.0|0.71|1.43|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 0-4||1.43|0.71|0.9541
91633033|NCT01021553|183159301|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.33||||0.2798|TWO_SIDED|95.0|0.79|2.24|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||2.24|0.79|0.2798
91633034|NCT01021553|183159301|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.09||||0.7255|TWO_SIDED|95.0|0.68|1.75|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.75|0.68|0.7255
91633035|NCT01021553|183159301|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.18||||0.4347|TWO_SIDED|95.0|0.77|1.8|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.80|0.77|0.4347
91484359|NCT04571515|182842572|SUPERIORITY||Mean Difference (Final Values)|28.3|STANDARD_ERROR_OF_MEAN|9.25||0.003|TWO_SIDED|95.0|9.9|46.6|||Emax|||||46.6|9.9|0.003
91484360|NCT04571515|182842572|SUPERIORITY||Mean Difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|7.94|<|0.001|TWO_SIDED|95.0|13.8|45.3|||Emax|||||45.3|13.8|<0.001
91484361|NCT04571515|182842572|SUPERIORITY||Mean Difference (Final Values)|30.3|STANDARD_ERROR_OF_MEAN|8.04|<|0.001|TWO_SIDED|95.0|14.4|46.2|||Emax|||||46.2|14.4|<0.001
91484362|NCT04571515|182842572|SUPERIORITY||Mean Difference (Final Values)|31.1|STANDARD_ERROR_OF_MEAN|8.87|<|0.001|TWO_SIDED|95.0|13.5|48.6|||Emax|||||48.6|13.5|<0.001
91484363|NCT04571515|182842573|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.4|1.1||||||||1.1|-1.4|
91667017|NCT05194202|183228034|OTHER|||||||0.622|||||||one-sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test.||Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.622
91667018|NCT05194202|183228035|OTHER|||||||0.038|||||||one sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test||Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.038
91484364|NCT04571515|182842573|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.5|0.9||||||||0.9|-1.5|
91484365|NCT04571515|182842573|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.8|0.6||||||||0.6|-1.8|
91633036|NCT01021553|183159302|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.14||||0.6583|TWO_SIDED|95.0|0.63|2.05|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||2.05|0.63|0.6583
91633037|NCT01021553|183159302|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|0.96||||0.879|TWO_SIDED|95.0|0.56|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.56|0.8790
91633038|NCT01021553|183159302|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.8971|TWO_SIDED|95.0|0.64|1.67|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.67|0.64|0.8971
91633039|NCT01021553|183159305|SUPERIORITY_OR_OTHER||Ratio of treatments|2.91|||||TWO_SIDED|90.0|2.43|3.48|||||For AUC (0-inf)|||3.48|2.43|
91633040|NCT01021553|183159305|SUPERIORITY_OR_OTHER||Ratio of treatments|2.98|||||TWO_SIDED|90.0|2.51|3.54||||||||3.54|2.51|
91633041|NCT01021553|183159306|SUPERIORITY_OR_OTHER||Ratio of treatments|3.63|||||TWO_SIDED|90.0|2.95|4.47||||||||4.47|2.95|
91633042|NCT01833806|183159367|SUPERIORITY||Proportion Difference|0.78|||=|0.01|TWO_SIDED|95.0|0.58|0.98|||Binomial|||The alternative hypothesis test was that the proportion of Responders would be greater than the proportion of subjects experiencing pain progression. This PAS was powered to enroll 70 subjects based on the pivotal trial proportion of 18:8 (Responders:Pain progression). The study was closed at an enrollment of 32 subjects.||0.98|0.58|= 0.01
91633043|NCT02724111|183159370|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91633044|NCT02724111|183159371|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91633045|NCT02724111|183159372|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91633046|NCT02724111|183159373|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91633047|NCT02724111|183159374|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91633048|NCT02724111|183159375|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91633049|NCT02724111|183159376|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91633050|NCT02724111|183159377|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
91667019|NCT00660387|183228038|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
91792491|NCT04761627|183462686|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric Least Squares (LS) Means Ratio|0.9325|||||TWO_SIDED|90.0|0.8874|0.9799|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% confidence intervals (CIs) were estimated using the analysis of covariance (ANCOVA) model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||0.9799|0.8874|
91633051|NCT02996500|183159378|SUPERIORITY||Mean Difference (Net)|-7.83||||0.005|TWO_SIDED|95.0|-13.73|-1.97|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-1.97|-13.73|0.0050
91633052|NCT02996500|183159378|SUPERIORITY||Mean Difference (Net)|-8.96|||<|0.001|TWO_SIDED|95.0|-14.37|-3.66|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-3.66|-14.37|<0.001
91633053|NCT02996500|183159378|SUPERIORITY||Median Difference (Net)|-10.89|||<|0.001|TWO_SIDED|95.0|-16.36|-5.63|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.63|-16.36|<0.001
91633054|NCT02996500|183159378|SUPERIORITY||Mean Difference (Net)|-11.29|||<|0.001|TWO_SIDED|95.0|-16.62|-5.92|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.92|-16.62|<0.001
91484366|NCT04571515|182842573|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.1|1.3||||||||1.3|-1.1|
91484367|NCT04571515|182842574|SUPERIORITY||Mean Difference (Final Values)|15.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|7.3|23.1|||Emax|||||23.1|7.3|<0.001
91633055|NCT00835276|183159433|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.96||||||90.0|80.15|96.53|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||96.53|80.15|
91667020|NCT00660387|183228039|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
91692042|NCT02174627|183278572|OTHER||Rate of Change Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.254||0.046|TWO_SIDED|95.0|-1.0|-0.01||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Random Effects Analysis|||Difference between groups (roxadustat minus placebo) in rate of change in eGFR; random effects analysis.||-0.01|-1.00|0.046
91692043|NCT02174627|183278573|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.269||0.051|TWO_SIDED|95.0|0.0|1.05||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||1.05|0.00|0.051
91692044|NCT02166333|183278574|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.54|TWO_SIDED|95.0|0.76|1.15||The P value is nominal and two-sided.|Log Rank||The Experience on Best Dose versus 200 IU/day hazard ratio and its 95% confidence interval were derived from a Cox regression model with dose group as the single model variable.|The Experience on Best Dose group includes all participants assigned or switched to best dose (1000 IU/day) and excludes 41 participants randomized to 2000 or 4000 IU/day who were never issued a bottle of best dose. For those randomized to 2000 or 4000 IU/day, at-risk time and events are measured from the date of their switch to best dose. 150 Experience on Best Dose participants (median follow-up, 10.2 mos) and 125 200 IU/day participants (median follow-up, 20.3 mos) were censored.||1.15|0.76|0.54
91692045|NCT02166333|183278574|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.86|1.25|||||The comparison of the Pooled Higher Doses group versus the 200 IU/d group is a sensitivity analysis.|||1.25|0.86|
91692046|NCT02166333|183278575|SUPERIORITY|The overall P tests for difference between groups in differential change from baseline over time and is from a 3 degree of freedom test of the combined 3 treatment-by-time interaction terms from the longitudinal mixed effects model.||||||0.15||||||The P value is nominal and not adjusted for multiple comparisons.|Regression, Linear|3 degree of freedom interaction test||The two groups were assessed for differential change over time in change from baseline using a longitudinal mixed effects regression model with gait speed as the outcome and fixed effects including a single treatment term, 3 time point terms and 3 treatment-by-time interaction terms and a random intercept for participant.||||0.15
91692047|NCT00503698|183278576|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.91|TWO_SIDED|95.0|0.6|1.57|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.57|0.60|0.91
91484368|NCT04571515|182842574|SUPERIORITY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|9.3|22.9|||Emax|||||22.9|9.3|<0.001
91484369|NCT04571515|182842574|SUPERIORITY||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|9.7|23.4|||Emax|||||23.4|9.7|<0.001
91692048|NCT00503698|183278577|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.4977|TWO_SIDED|95.0|0.6|1.28|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.28|0.60|0.4977
91692049|NCT00503698|183278578|SUPERIORITY_OR_OTHER||Rate ratio|1.13||||0.4409|TWO_SIDED|95.0|0.83|1.53|||Negative binomial regression|||||1.53|0.83|0.4409
91633056|NCT00835276|183159434|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.15|98.26|||||To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.|||98.26|85.15|
91633057|NCT00835276|183159435|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.32|98.07|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||98.07|85.32|
91633058|NCT02332876|183159458|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91633059|NCT02402881|183159459|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
91633060|NCT02402881|183159460|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
91633061|NCT00415623|183159466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|||<|0.001||95.0|-9.0|-4.4|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-4.4|-9.0|<0.001
91633062|NCT00415623|183159467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|||<|0.001||95.0|-5.7|-2.5|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.5|-5.7|<0.001
91633063|NCT00415623|183159468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|||<|0.001||95.0|-9.1|-5.1|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-5.1|-9.1|<0.001
91667021|NCT00660387|183228040|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the CGI-Severity (CGI-S, see Baseline Characteristics module) as a covariate.|ANCOVA|||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
91667022|NCT00660387|183228041|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
91692050|NCT01766076|183278586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann Whitney test was used for nonparametric variables||||||<0.05
91692051|NCT04955691|183278646|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91484370|NCT04571515|182842574|SUPERIORITY||Mean Difference (Final Values)|17.1|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|9.4|24.7|||Emax|||||24.7|9.4|<0.001
91484371|NCT04571515|182842575|SUPERIORITY|||||||0.208|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.208
91633064|NCT00415623|183159469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.001||95.0|-5.4|-2.6|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.6|-5.4|<0.001
91633065|NCT00415623|183159470|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.002||95.0|1.36|3.99|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||3.99|1.36|0.002
91633066|NCT00415623|183159471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.46|||<|0.001||95.0|2.28|8.74|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.74|2.28|<0.001
91667023|NCT00660387|183228042|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
91667024|NCT00660387|183228043|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
91667025|NCT00660387|183228044|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
91667026|NCT00660387|183228045|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
91692052|NCT04955691|183278647|SUPERIORITY|||||||0.57|||||||t-test, 1 sided|||\<54 mg/dL||||0.57
91633067|NCT00415623|183159472|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.001||95.0|1.5|4.36|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||4.36|1.50|0.001
91633068|NCT00415623|183159473|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.16|||<|0.001||95.0|2.12|8.19|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.19|2.12|<0.001
91633069|NCT01369069|183159476|SUPERIORITY||Risk Ratio (RR)|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08||The a priori threshold for statistical significance was 0.05.|Regression, Logistic||Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.|It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.||1.08|0.87|0.55
91484372|NCT04571515|182842575|SUPERIORITY|||||||0.005|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.005
91633070|NCT01369069|183159477|SUPERIORITY||Risk Difference (RD)|2.58|||<|0.001|TWO_SIDED|95.0|1.29|3.87|||Fisher Exact||The data of the estimation parameter and the confidence intervals were presented as percentages.|||3.87|1.29|<0.001
91633071|NCT01369069|183159478|SUPERIORITY||Risk Difference (RD)|-1.07||||0.77|TWO_SIDED|95.0|-8.33|6.2|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.20|-8.33|0.77
91633072|NCT01369069|183159479|SUPERIORITY||Risk Difference (RD)|0.48||||0.88|TWO_SIDED|95.0|-5.79|6.75|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.75|-5.79|0.88
91633073|NCT01369069|183159480|SUPERIORITY||Median Difference (Final Values)|0.06||||0.74|TWO_SIDED|95.0|-0.13|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|-0.13|0.74
91633074|NCT01369069|183159481|SUPERIORITY||Risk Ratio (RR)|0.82||||0.24|TWO_SIDED|95.0|0.58|1.15|||Chi-squared|||||1.15|0.58|0.24
91692053|NCT04955691|183278647|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||54-69 mg/dL||||0.43
91484373|NCT04571515|182842575|SUPERIORITY|||||||0.192|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.192
91633075|NCT02573012|183159482|SUPERIORITY||Least Square Means|0.613||||0.001|TWO_SIDED|95.0|0.346|0.879|||ANCOVA|||||0.879|0.346|0.001
91633076|NCT02573012|183159483|SUPERIORITY||Odds Ratio (OR)|0.5||||0.018|TWO_SIDED|95.0|0.285|0.889|||Regression, Logistic|||||0.889|0.285|0.018
91633077|NCT02573012|183159483|SUPERIORITY||Relative Risk|0.833||||0.021|TWO_SIDED|95.0|0.714|0.972|||Cochran-Mantel-Haenszel|||||0.972|0.714|0.021
91484374|NCT04571515|182842575|SUPERIORITY|||||||0.067|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.067
91633078|NCT02573012|183159484|SUPERIORITY||Least Square Mean|2.342||||0.006|TWO_SIDED|95.0|0.661|4.023|||ANCOVA|||||4.023|0.661|0.006
91633079|NCT02573012|183159504|SUPERIORITY||Least Square Means|2.264||||0.009||95.0|0.574|3.953|||ANCOVA|||||3.953|0.574|0.009
91633080|NCT02253173|183159565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633081|NCT02253173|183159565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633082|NCT02253173|183159565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633083|NCT02253173|183159566|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633084|NCT02253173|183159566|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633085|NCT02253173|183159566|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633086|NCT02253173|183159567|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91667027|NCT00660387|183228046|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
91633087|NCT02253173|183159567|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633088|NCT02253173|183159567|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633089|NCT02253173|183159568|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
91633090|NCT02253173|183159568|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633091|NCT02253173|183159568|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633092|NCT02253173|183159569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633093|NCT02253173|183159569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633094|NCT02253173|183159569|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633095|NCT02253173|183159570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633096|NCT02253173|183159570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633097|NCT02253173|183159570|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633098|NCT02253173|183159571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633099|NCT02253173|183159571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633100|NCT02253173|183159571|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633101|NCT02253173|183159572|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633102|NCT02253173|183159572|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633103|NCT02253173|183159572|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633104|NCT02253173|183159573|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633105|NCT02253173|183159573|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633106|NCT02253173|183159573|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633107|NCT02253173|183159574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633108|NCT02253173|183159574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633109|NCT02253173|183159574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633110|NCT02253173|183159575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633111|NCT02253173|183159575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633112|NCT02253173|183159575|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633113|NCT02253173|183159576|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633114|NCT02253173|183159576|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633115|NCT02253173|183159576|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633116|NCT02253173|183159577|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633117|NCT02253173|183159577|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633118|NCT02253173|183159577|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633119|NCT02253173|183159578|SUPERIORITY_OR_OTHER|||||||0.026|||||||Mixed Models Analysis|||||||0.0260
91633120|NCT02253173|183159578|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
91633121|NCT02253173|183159578|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
91633122|NCT02253173|183159579|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|||||||0.0069
91633123|NCT02253173|183159579|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Mixed Models Analysis|||||||0.0009
91633124|NCT02253173|183159579|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633125|NCT02253173|183159580|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
91633126|NCT02253173|183159580|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633127|NCT02253173|183159580|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633128|NCT02253173|183159581|SUPERIORITY_OR_OTHER|||||||0.1269|||||||Mixed Models Analysis|||||||0.1269
91633129|NCT02253173|183159581|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
91633130|NCT02253173|183159581|SUPERIORITY_OR_OTHER|||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
91633131|NCT02253173|183159582|SUPERIORITY_OR_OTHER|||||||0.0094|||||||Mixed Models Analysis|||||||0.0094
91633132|NCT02253173|183159582|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
91633133|NCT02253173|183159582|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
91633134|NCT02253173|183159583|SUPERIORITY_OR_OTHER|||||||0.0128|||||||Mixed Models Analysis|||||||0.0128
91633135|NCT02253173|183159583|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633136|NCT02253173|183159583|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
91633137|NCT02253173|183159584|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
91633138|NCT02253173|183159584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633139|NCT02253173|183159584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633140|NCT02253173|183159585|SUPERIORITY_OR_OTHER|||||||0.9616|||||||Mixed Models Analysis|||||||0.9616
91633141|NCT02253173|183159585|SUPERIORITY_OR_OTHER|||||||0.2439|||||||Mixed Models Analysis|||||||0.2439
91633142|NCT02253173|183159585|SUPERIORITY_OR_OTHER|||||||0.6518|||||||Mixed Models Analysis|||||||0.6518
91633143|NCT02253173|183159586|SUPERIORITY_OR_OTHER|||||||0.7829|||||||Mixed Models Analysis|||||||0.7829
91633144|NCT02253173|183159586|SUPERIORITY_OR_OTHER|||||||0.2328|||||||Mixed Models Analysis|||||||0.2328
91633145|NCT02253173|183159586|SUPERIORITY_OR_OTHER|||||||0.4118|||||||Mixed Models Analysis|||||||0.4118
91633146|NCT02253173|183159587|SUPERIORITY_OR_OTHER|||||||0.0639|||||||Mixed Models Analysis|||||||0.0639
91633147|NCT02253173|183159587|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Mixed Models Analysis|||||||0.0356
91633148|NCT02253173|183159587|SUPERIORITY_OR_OTHER|||||||0.0914|||||||Mixed Models Analysis|||||||0.0914
91792492|NCT04761627|183462687|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9483|||||TWO_SIDED|90.0|0.8977|1.0018|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% CIs were estimated using the ANCOVA model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||1.0018|0.8977|
91633149|NCT02253173|183159588|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Mixed Models Analysis|||||||0.0503
91633150|NCT02253173|183159588|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Mixed Models Analysis|||||||0.0055
91633151|NCT02253173|183159588|SUPERIORITY_OR_OTHER|||||||0.0263|||||||Mixed Models Analysis|||||||0.0263
91633152|NCT02253173|183159589|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633153|NCT02253173|183159589|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633154|NCT02253173|183159589|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633155|NCT02253173|183159590|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633156|NCT02253173|183159590|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91667028|NCT00660387|183228047|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
91667029|NCT00660387|183228048|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
91667030|NCT00660387|183228049|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
91667031|NCT00660387|183228050|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
91667032|NCT00660387|183228051|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
91484375|NCT04571515|182842575|SUPERIORITY|||||||0.059|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.059
91633157|NCT02253173|183159590|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633158|NCT02253173|183159591|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633159|NCT02253173|183159591|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633160|NCT02253173|183159591|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633161|NCT02253173|183159592|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633162|NCT02253173|183159592|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633163|NCT02253173|183159592|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633164|NCT02253173|183159593|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633165|NCT02253173|183159593|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91667033|NCT00660387|183228052|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
91633166|NCT02253173|183159593|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633167|NCT02253173|183159594|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633168|NCT02253173|183159594|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633169|NCT02253173|183159594|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633170|NCT02253173|183159595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633171|NCT02253173|183159595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633172|NCT02253173|183159595|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633173|NCT02253173|183159596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633174|NCT02253173|183159596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633175|NCT02253173|183159596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633176|NCT02253173|183159597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633177|NCT02253173|183159597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633178|NCT02253173|183159597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633179|NCT02253173|183159598|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633180|NCT02253173|183159598|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633181|NCT02253173|183159598|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633182|NCT02253173|183159599|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633183|NCT02253173|183159599|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633184|NCT02253173|183159599|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633185|NCT02253173|183159600|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633186|NCT02253173|183159600|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633187|NCT02253173|183159600|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633188|NCT02253173|183159601|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
91692054|NCT04955691|183278648|SUPERIORITY|||||||0.006|||||||t-test, 1 sided|||181-250 mg/dL||||0.006
91667034|NCT00660387|183228053|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
91667035|NCT00660387|183228054|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
91667036|NCT00660387|183228055|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
91667037|NCT00660387|183228056|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
91667038|NCT00660387|183228057|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
91667039|NCT00660387|183228058|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
91667040|NCT00660387|183228059|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
91667041|NCT03086135|183228062|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
91667042|NCT03086135|183228063|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in noise at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
91667043|NCT03086135|183228064|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91484376|NCT04571515|182842575|SUPERIORITY||||||<|0.001|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||<0.001
91484377|NCT04571515|182842575|SUPERIORITY|||||||0.017|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.017
91484378|NCT04571515|182842575|SUPERIORITY|||||||0.002|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.002
91667044|NCT03086135|183228064|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91484379|NCT04571515|182842576|SUPERIORITY|||||||0.051|||||||Regression, Logistic|||||||0.051
91484380|NCT04571515|182842576|SUPERIORITY|||||||0.035|||||||Regression, Logistic|||||||0.035
91667045|NCT03086135|183228064|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667046|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667047|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667048|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667049|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667050|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667051|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667052|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667053|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667054|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667055|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667056|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667057|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667058|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667059|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667060|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91692055|NCT04955691|183278648|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||\>250 mg/dL||||<0.001
91667061|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667062|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667063|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667064|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667065|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667066|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667067|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667068|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667069|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91714379|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2686||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2686
91714380|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0753||95.0|-1.2|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.2|0.0753
91484381|NCT04571515|182842576|SUPERIORITY|||||||0.016|||||||Regression, Logistic|||||||0.016
91484382|NCT04571515|182842576|SUPERIORITY|||||||0.18|||||||Regression, Logistic|||||||0.180
91484383|NCT04571515|182842577|SUPERIORITY|||||||0.022|||||||Wilcoxon Rank Sum|||||||0.022
91484384|NCT04571515|182842577|SUPERIORITY|||||||0.028|||||||Wilcoxon Rank Sum|||||||0.028
91484385|NCT04571515|182842577|SUPERIORITY|||||||0.007|||||||Wilcoxon Rank Sum|||||||0.007
91484386|NCT04571515|182842577|SUPERIORITY|||||||0.005|||||||Wilcoxon Rank Sum|||||||0.005
91667070|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667071|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667072|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667073|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667074|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667075|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667076|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667077|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667078|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667079|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667080|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667081|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667082|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667083|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667084|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667085|NCT03086135|183228065|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667086|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667087|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667088|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667089|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667090|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91484387|NCT06624449|182842581|SUPERIORITY||Mean Difference (Final Values)|0.09|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
91484388|NCT05098938|182842583|SUPERIORITY|||||||0.716|||||||Log Rank|||||||0.716
91484389|NCT05098938|182842584|SUPERIORITY|||||||0.102|||||||Chi-squared|||||||0.102
91484390|NCT05098938|182842585|SUPERIORITY|||||||0.712|||||||Chi-squared|||||||0.712
91484391|NCT05098938|182842586|SUPERIORITY|||||||0.575|||||||Log Rank|||||||0.575
91633189|NCT02253173|183159601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633190|NCT02253173|183159601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633191|NCT02253173|183159602|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
91633192|NCT02253173|183159602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633193|NCT02253173|183159602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633194|NCT02253173|183159603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633195|NCT02253173|183159603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633196|NCT02253173|183159603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633197|NCT02253173|183159604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633198|NCT02253173|183159604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633199|NCT02253173|183159604|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91633200|NCT02253173|183159605|SUPERIORITY_OR_OTHER|||||||0.9075|||||||ANCOVA|||||||0.9075
91633201|NCT02253173|183159605|SUPERIORITY_OR_OTHER|||||||0.0492|||||||ANCOVA|||||||0.0492
91633202|NCT02253173|183159605|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
91633203|NCT02253173|183159606|SUPERIORITY_OR_OTHER|||||||0.9719|||||||ANCOVA|||||||0.9719
91633204|NCT02253173|183159606|SUPERIORITY_OR_OTHER|||||||0.0614|||||||ANCOVA|||||||0.0614
91633205|NCT02253173|183159606|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|||||||0.0085
91633206|NCT02253173|183159607|SUPERIORITY_OR_OTHER|||||||0.9999|||||||ANCOVA|||||||0.9999
91633207|NCT02253173|183159607|SUPERIORITY_OR_OTHER|||||||0.2855|||||||ANCOVA|||||||0.2855
91633208|NCT02253173|183159607|SUPERIORITY_OR_OTHER|||||||0.1189|||||||ANCOVA|||||||0.1189
91633209|NCT02253173|183159608|SUPERIORITY_OR_OTHER|||||||0.4162|||||||ANCOVA|||||||0.4162
91633210|NCT02253173|183159608|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||||||0.0013
91633211|NCT02253173|183159608|SUPERIORITY_OR_OTHER|||||||0.0003|||||||ANCOVA|||||||0.0003
91633212|NCT02253173|183159609|SUPERIORITY_OR_OTHER|||||||0.9929|||||||ANCOVA|||||||0.9929
91633213|NCT02253173|183159609|SUPERIORITY_OR_OTHER|||||||0.9634|||||||ANCOVA|||||||0.9634
91633214|NCT02253173|183159609|SUPERIORITY_OR_OTHER|||||||0.0898|||||||ANCOVA|||||||0.0898
91633215|NCT02253173|183159610|SUPERIORITY_OR_OTHER|||||||0.5146|||||||ANCOVA|||||||0.5146
91633216|NCT02253173|183159610|SUPERIORITY_OR_OTHER|||||||0.0099|||||||ANCOVA|||||||0.0099
91633217|NCT02253173|183159610|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.0150
91633218|NCT02253173|183159611|SUPERIORITY_OR_OTHER|||||||0.9039|||||||ANCOVA|||||||0.9039
91633219|NCT02253173|183159611|SUPERIORITY_OR_OTHER|||||||0.3751|||||||ANCOVA|||||||0.3751
91633220|NCT02253173|183159611|SUPERIORITY_OR_OTHER|||||||0.0073|||||||ANCOVA|||||||0.0073
91633221|NCT02545049|183159615|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0264|TWO_SIDED|95.0|0.76|0.98||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.98|0.76|0.0264
91633222|NCT02545049|183159616|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.87||||0.0689|TWO_SIDED|95.0|0.76|1.01||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.01|0.76|0.0689
91633223|NCT02545049|183159617|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.97||||0.3558|TWO_SIDED|95.0|0.9|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.90|0.3558
91633224|NCT02545049|183159618|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.89||||0.1337|TWO_SIDED|95.0|0.77|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.77|0.1337
91714381|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1335||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1335
91714382|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.022||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0220
91714383|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5754||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.5754
91792493|NCT04761627|183462689|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9617|||||TWO_SIDED|90.0|0.8319|1.1119|||||Ctrough,ss at Week 28: Switching group vs Continued-use group|The ratio of Geometric LS means, and 90% CI for Ctrough,ss at week 28 were estimated based on an ANCOVA model adjusted for the actual stratification factors of prior biologic use for psoriasis, baseline body weight group, and geographic region.||1.1119|0.8319|
91633225|NCT02545049|183159619|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Ratio of least squares means|0.676|||<|0.0001|TWO_SIDED|95.0|0.65|0.704||P-value from F-test of equal means between the treatment groups. A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|ANCOVA|||||0.704|0.650|<0.0001
91633226|NCT02545049|183159620|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.77||||0.0406|TWO_SIDED|95.0|0.6|0.99||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.99|0.60|0.0406
91633227|NCT04191096|183159624|OTHER||Hazard Ratio (HR)|1.2||||0.9467|TWO_SIDED|95.0|0.96|1.49||A one-sided p-value was calculated using the log-rank test stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.49|0.96|0.9467
91633228|NCT04191096|183159625|OTHER||Hazard Ratio (HR)|1.16||||0.85122|TWO_SIDED|95.0|0.88|1.53||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.53|0.88|0.85122
91633229|NCT04191096|183159626|OTHER||Hazard Ratio (HR)|1.24||||0.97907|TWO_SIDED|95.0|1.01|1.54||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.54|1.01|0.97907
91633230|NCT04191096|183159627|OTHER||Hazard Ratio (HR)|0.89||||0.27202|TWO_SIDED|95.0|0.61|1.3||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.30|0.61|0.27202
91633231|NCT04191096|183159628|OTHER||Hazard Ratio (HR)|0.92||||0.2972|TWO_SIDED|95.0|0.69|1.23||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.23|0.69|0.2972
91633232|NCT04191096|183159629|OTHER||Hazard Ratio (HR)|1.07||||0.6863|TWO_SIDED|95.0|0.81|1.41||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.41|0.81|0.6863
91792494|NCT04761627|183462689|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9662|||||TWO_SIDED|90.0|0.8879|1.0515|||||Ctrough,ss at Week 40: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 40 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0515|0.8879|
91484392|NCT00942448|182842589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|||||||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||||< 0.001
91484393|NCT00942448|182842589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1||||0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||||31.7|18.4|0.001
91633233|NCT04191096|183159630|OTHER||Hazard Ratio (HR)|1.15||||0.9235|TWO_SIDED|95.0|0.95|1.39||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.39|0.95|0.9235
91633234|NCT04191096|183159631|OTHER||Hazard Ratio (HR)|1.16||||0.8801|TWO_SIDED|95.0|0.9|1.5||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.50|0.90|0.8801
91633235|NCT04191096|183159632|OTHER||Percent Difference|-2.7||||0.9576|TWO_SIDED|95.0|-5.8|0.4||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen method||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||0.4|-5.8|0.9576
91633236|NCT04191096|183159633|OTHER||Percent difference|-0.8||||0.6053|TWO_SIDED|95.0|-6.3|4.8||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||4.8|-6.3|0.6053
91667091|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667092|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667093|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667094|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667095|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667096|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91484394|NCT00942448|182842602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|TWO_SIDED|95.0|17.6|30.8|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||30.8|17.6|< 0.001
91667097|NCT03086135|183228066|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91525811|NCT02567825|182927152|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.67|1.01|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at low risk of AOM recurrences at enrollment..||1.01|0.67|
91667098|NCT03086135|183228067|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
91667099|NCT03086135|183228067|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667100|NCT03086135|183228067|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667101|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667102|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667103|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667104|NCT03086135|183228068|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.||||0.51
91667105|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667106|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91525812|NCT02567825|182927152|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at high risk of AOM recurrences at enrollment.||1.33|0.86|
91633237|NCT04191096|183159634|OTHER||Percent difference|-5.6||||0.9105|TWO_SIDED|95.0|-13.7|2.6||One-sided p-value based on Miettinen \& Nurminen method stratified prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||2.6|-13.7|0.9105
91633238|NCT00003389|183159654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.32
91633239|NCT00003389|183159655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.86
91633240|NCT01901809|183159697|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|4.7||0.018|TWO_SIDED|95.0|2.0|20.8|||t-test, 2 sided|||||20.8|2.0|0.018
91633241|NCT01901809|183159698|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.8||0.33|TWO_SIDED|95.0|-14.4|4.9|||t-test, 2 sided|||||4.9|-14.4|0.33
91633242|NCT02776904|183159699|OTHER|||||||0.0003||||||Adjustment with Tukey-Kramer|ANOVA|3 DF||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory||||0.0003
91633243|NCT02776904|183159699|OTHER|||||||0.0281||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory||||0.0281
91633244|NCT02776904|183159699|OTHER|||||||0.0035||||||Adjusted for multiple comparisons|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite||||0.0035
91633245|NCT02776904|183159700|OTHER|||||||0.2637||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time||||0.2637
91633246|NCT02776904|183159701|OTHER||||||<|0.001||||||Used Tukey's Adjustment|ANOVA|||Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance)||||<0.001
91633247|NCT02776904|183159702|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance).|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.||||||< 0.0001
91714384|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.348||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3480
91633248|NCT02776904|183159703|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pairwise comparisons with p\<.05.||||||< 0.0001
91633249|NCT02776904|183159704|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.||||||< 0.0001
91633250|NCT02776904|183159705|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91633251|NCT02776904|183159706|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91633252|NCT02776904|183159707|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91633253|NCT04657003|183159709|SUPERIORITY||LSMean Mean Difference (Net)|-10.1|||<|0.001|TWO_SIDED|95.0|-11.5|-8.8|||Mixed Models Analysis|||||-8.8|-11.5|<0.001
91633254|NCT04657003|183159709|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.7|-11.0|||Mixed Models Analysis|||||-11.0|-13.7|<0.001
91633255|NCT04657003|183159710|SUPERIORITY||Odds Ratio (OR)|10.75|||<|0.001|TWO_SIDED|95.0|7.3|15.84|||Regression, Logistic|||||15.84|7.30|<0.001
91633256|NCT04657003|183159710|SUPERIORITY||Odds Ratio (OR)|15.28|||<|0.001|TWO_SIDED|95.0|10.08|23.14|||Regression, Logistic|||||23.14|10.08|<0.001
91633257|NCT04657003|183159711|SUPERIORITY||Odds Ratio (OR)|20.94|||<|0.001|TWO_SIDED|95.0|13.06|33.58|||Regression, Logistic|||||33.58|13.06|<0.001
91633258|NCT04657003|183159711|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|17.04|44.39|||Regression, Logistic|||||44.39|17.04|<0.001
91633259|NCT04657003|183159712|SUPERIORITY||Odds Ratio (OR)|28.38|||<|0.001|TWO_SIDED|95.0|13.81|58.31|||Regression, Logistic|||||58.31|13.81|<0.001
91633260|NCT04657003|183159712|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|21.2|89.67|||Regression, Logistic|||||89.67|21.20|<0.001
91633261|NCT04657003|183159713|SUPERIORITY||Odds Ratio (OR)|28.54|||<|0.001|TWO_SIDED|95.0|9.73|83.73|||Regression, Logistic|||||83.73|9.73|<0.001
91633262|NCT04657003|183159713|SUPERIORITY||Odds Ratio (OR)|49.68|||<|0.001|TWO_SIDED|95.0|17.03|144.94|||Regression, Logistic|||||144.94|17.03|<0.001
91633263|NCT04657003|183159714|SUPERIORITY||LSMean Mean Difference (Net)|-10.3|||<|0.001|TWO_SIDED|95.0|-11.7|-8.8|||Mixed Models Analysis|||||-8.8|-11.7|<0.001
91633264|NCT04657003|183159714|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.8|-11.0|||Mixed Models Analysis|||||-11.0|-13.8|<0.001
91484395|NCT00942448|182842602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||31.7|18.4|<0.001
91633265|NCT04657003|183159715|SUPERIORITY||LSMean Mean Difference (Net)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.2|-3.2|||Mixed Models Analysis|||||-3.2|-4.2|<0.001
91633266|NCT04657003|183159715|SUPERIORITY||LSMean Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-5.0|-4.0|||Mixed Models Analysis|||||-4.0|-5.0|<0.001
91633267|NCT04657003|183159716|SUPERIORITY||LSMean Mean Difference (Net)|-1.97|||<|0.001|TWO_SIDED|95.0|-2.15|-1.8|||Mixed Models Analysis|||||-1.80|-2.15|<0.001
91633268|NCT04657003|183159716|SUPERIORITY||LSMean Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.24|-1.88|||Mixed Models Analysis|||||-1.88|-2.24|<0.001
91633269|NCT04657003|183159717|SUPERIORITY||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|17.21|45.59|||Regression, Logistic|||||45.59|17.21|<0.001
91633270|NCT04657003|183159717|SUPERIORITY||Odds Ratio (OR)|34.19|||<|0.001|TWO_SIDED|95.0|20.27|57.67|||Regression, Logistic|||||57.67|20.27|<0.001
91633271|NCT04657003|183159718|SUPERIORITY||Odds Ratio (OR)|42.11|||<|0.001|TWO_SIDED|95.0|25.61|69.26|||Regression, Logistic|||||69.26|25.61|<0.001
91633272|NCT04657003|183159718|SUPERIORITY||Odds Ratio (OR)|58.67|||<|0.001|TWO_SIDED|95.0|34.29|100.37|||Regression, Logistic|||||100.37|34.29|<0.001
91633273|NCT04657003|183159719|SUPERIORITY||Odds Ratio (OR)|42.55|||<|0.001|TWO_SIDED|95.0|20.46|88.5|||Regression, Logistic|||||88.50|20.46|<0.001
91633274|NCT04657003|183159719|SUPERIORITY||Odds Ratio (OR)|54.3|||<|0.001|TWO_SIDED|95.0|26.0|113.38|||Regression, Logistic|||||113.38|26.00|<0.001
91633275|NCT04657003|183159720|SUPERIORITY||LSMean Mean Difference (Net)|-46.79|||<|0.001|TWO_SIDED|95.0|-52.67|-40.91|||Mixed Models Analysis|||||-40.91|-52.67|<0.001
91667107|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667108|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91633276|NCT04657003|183159720|SUPERIORITY||LSMean Mean Difference (Net)|-49.25|||<|0.001|TWO_SIDED|95.0|-55.18|-43.33|||Mixed Models Analysis|||||-43.33|-55.18|<0.001
91633277|NCT04657003|183159721|SUPERIORITY||LSMean Mean Difference (Net)|-7.8|||<|0.001|TWO_SIDED|95.0|-9.2|-6.4|||Mixed Models Analysis|||||-6.4|-9.2|<0.001
91633278|NCT04657003|183159721|SUPERIORITY||LSMean Mean Difference (Net)|-10.4|||<|0.001|TWO_SIDED|95.0|-11.8|-8.9|||Mixed Models Analysis|||||-8.9|-11.8|<0.001
91633279|NCT04657003|183159722|SUPERIORITY||Estimate Difference|-4.61|||<|0.001|TWO_SIDED|95.0|-7.11|-2.03|||Mixed Models Analysis|||||-2.03|-7.11|<0.001
91633280|NCT04657003|183159723|SUPERIORITY||Estimate Difference|-3.36||||0.112|TWO_SIDED|95.0|-7.36|0.81|||Mixed Models Analysis|||||0.81|-7.36|0.112
91633281|NCT04657003|183159724|SUPERIORITY||Estimate Difference|7.02|||<|0.001|TWO_SIDED|95.0|4.4|9.71|||Mixed Models Analysis|||||9.71|4.40|<0.001
91633282|NCT04657003|183159725|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-27.5|-18.9|||Mixed Models Analysis|||||-18.9|-27.5|<0.001
91633283|NCT04657003|183159726|SUPERIORITY||Estimate Difference|-24.2|||<|0.001|TWO_SIDED|95.0|-28.6|-19.6|||Mixed Models Analysis|||||-19.6|-28.6|<0.001
91633284|NCT04657003|183159727|SUPERIORITY||Estimate Difference|-8.74|||<|0.001|TWO_SIDED|95.0|-12.04|-5.32|||Mixed Models Analysis|||||-5.32|-12.04|<0.001
91633285|NCT04657003|183159728|SUPERIORITY||Estimate Difference|-23.61|||<|0.001|TWO_SIDED|95.0|-28.62|-18.24|||Mixed Models Analysis|||||-18.24|-28.62|<0.001
91633286|NCT04657003|183159729|SUPERIORITY||LSMean Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-8.0|-4.4|||Mixed Models Analysis|||||-4.4|-8.0|<0.001
91633287|NCT04657003|183159730|SUPERIORITY||LSMean Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis|||||-1.3|-3.5|<0.001
91633288|NCT04657003|183159731|SUPERIORITY||Estimate Difference|-17.6|||<|0.001|TWO_SIDED|95.0|-25.5|-8.9|||Mixed Models Analysis|||||-8.9|-25.5|<0.001
91633289|NCT04657003|183159731|SUPERIORITY||Estimate Difference|-30.2|||<|0.001|TWO_SIDED|95.0|-37.0|-22.7|||Mixed Models Analysis|||||-22.7|-37.0|<0.001
91633290|NCT04657003|183159732|SUPERIORITY||LSMean Mean Difference (Net)|1.8||||0.001|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|||||2.9|0.7|0.001
91633291|NCT04657003|183159732|SUPERIORITY||LSMean Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.1|3.4|||ANCOVA|||||3.4|1.1|<0.001
91633292|NCT04657003|183159733|SUPERIORITY||LSMean Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|4.1|9.7|||ANCOVA|||||9.7|4.1|<0.001
91633293|NCT04657003|183159733|SUPERIORITY||LSMean Difference (Net)|7.8|||<|0.001|TWO_SIDED|95.0|5.0|10.7|||ANCOVA|||||10.7|5.0|<0.001
91633294|NCT00935766|183159735|SUPERIORITY_OR_OTHER|||||||0.21|||||||Mixed Models Analysis|||||||0.21
91633295|NCT00935766|183159736|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91633296|NCT00935766|183159737|SUPERIORITY_OR_OTHER|||||||0.36|||||||Mixed Models Analysis|||||||0.36
91633297|NCT02723019|183159792|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyzed using logistic regression analysis||||0.01
91633298|NCT02723019|183159793|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||||||0.19
91667109|NCT03086135|183228068|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.||||0.32
91667110|NCT03086135|183228068|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667111|NCT03086135|183228069|SUPERIORITY|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.||||0.026
91667112|NCT03086135|183228069|SUPERIORITY|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.||||0.50
91714385|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0554
91714386|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4362||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4362
91714387|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3631||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3631
91525813|NCT02567825|182927152|OTHER|||||||0.08|||||||Generalized linear models|||Null hypothesis: There is no interaction between comparison group (Surgical Management, Non-Surgical Management) and risk group (children considered at low risk of AOM recurrences at enrollment, children considered at high risk of AOM recurrences at enrollment).||||0.08
91633299|NCT02723019|183159794|SUPERIORITY|||||||0.73||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.73
91633300|NCT02723019|183159795|SUPERIORITY|||||||0.28||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.28
91633301|NCT02723019|183159796|SUPERIORITY|||||||0.71||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.71
91633302|NCT02723019|183159797|SUPERIORITY|||||||0.42|||||||negative binomial regression model analy|||negative binomial regression model analysis||||0.42
91633303|NCT00779116|183159895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
91633304|NCT00170846|183159900|SUPERIORITY_OR_OTHER||Difference in LS means|1.1241||||0.6332|TWO_SIDED|95.0|-3.5077|5.7559|||ANCOVA|||||5.7559|-3.5077|0.6332
91633305|NCT00170846|183159900|SUPERIORITY_OR_OTHER||Difference in LS means|0.5933||||0.7943|TWO_SIDED|95.0|-3.8815|5.0682|||ANCOVA|||||5.0682|-3.8815|0.7943
91633306|NCT01469637|183159917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|1.15|||||TWO_SIDED|90.0|1.12|1.18|||ANOVA|||||1.18|1.12|
91633307|NCT01469637|183159918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.09|1.15|||ANOVA|||||1.15|1.09|
91667113|NCT03086135|183228069|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.0008
91633308|NCT04716010|183159935|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.002
91633309|NCT04716010|183159935|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633310|NCT04716010|183159935|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633311|NCT04716010|183159935|SUPERIORITY|||||||0.024||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.024
91633312|NCT04716010|183159935|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633313|NCT04716010|183159935|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633314|NCT04716010|183159936|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.001
91667114|NCT03086135|183228069|SUPERIORITY|||||||0.082|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.082
91667115|NCT03086135|183228069|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.13
91667116|NCT03086135|183228069|SUPERIORITY|||||||0.9|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.9
91714388|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1152||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1152
91714389|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4741||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4741
91714390|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0091||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0091
91714391|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1721||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.1721
91484396|NCT01859143|182842631|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence criterion for fever within 7 days of vaccination mentioned that the upper limit of 95 percent (%) confidence interval (CI) for difference in percentage of participants with fever \>=101 degrees F should be less than 5 percentage points.|Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||A two-sided 95% CI was constructed using the exact method based on the score statistic proposed by Chan and Zhang.|||2.6|-5.3|
91633315|NCT04716010|183159936|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633316|NCT04716010|183159936|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633317|NCT04716010|183159936|SUPERIORITY|||||||0.022||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.022
91633318|NCT04716010|183159936|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633319|NCT04716010|183159936|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
91633320|NCT04716010|183159937|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \>0.05|Regression, Linear|||||||>0.05
91633321|NCT04716010|183159937|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633322|NCT04716010|183159937|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633323|NCT04716010|183159937|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633324|NCT04716010|183159937|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484397|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|11.9|||||TWO_SIDED|95.0|-1.9|23.9|||||Any symptom within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||23.9|-1.9|
91633325|NCT04716010|183159937|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633326|NCT04716010|183159938|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633327|NCT04716010|183159938|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633328|NCT04716010|183159938|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633329|NCT04716010|183159938|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633330|NCT04716010|183159938|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633331|NCT04716010|183159938|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633332|NCT04716010|183159939|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633333|NCT04716010|183159939|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633334|NCT04716010|183159939|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633335|NCT04716010|183159939|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633336|NCT04716010|183159939|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633337|NCT04716010|183159939|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633338|NCT04716010|183159940|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633339|NCT04716010|183159940|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633340|NCT04716010|183159940|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633341|NCT04716010|183159940|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633342|NCT04716010|183159940|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633343|NCT04716010|183159940|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91633344|NCT04716010|183159941|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633345|NCT04716010|183159941|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633346|NCT04716010|183159941|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484398|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>100 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
91667117|NCT03086135|183228069|SUPERIORITY|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.43
91667118|NCT03086135|183228069|SUPERIORITY|||||||0.31|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.31
91667119|NCT03086135|183228069|SUPERIORITY|||||||0.72|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.72
91667120|NCT03086135|183228069|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.13
91667121|NCT03086135|183228069|SUPERIORITY|||||||0.23|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.23
91667122|NCT03086135|183228069|SUPERIORITY|||||||0.0026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0026
91714392|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.0262||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0262
91484399|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
91484400|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
91484401|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|8.9|||||TWO_SIDED|95.0|-2.6|17.7|||||Runny nose within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||17.7|-2.6|
91484402|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|6.2|||||TWO_SIDED|95.0|-2.2|11.6|||||Sore throat within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.6|-2.2|
91633347|NCT04716010|183159941|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633348|NCT04716010|183159941|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633349|NCT04716010|183159941|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484403|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|-0.5|||||TWO_SIDED|95.0|-9.3|4.7|||||Cough within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.7|-9.3|
91484404|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Vomiting within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
91633350|NCT04716010|183159942|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633351|NCT04716010|183159942|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633352|NCT04716010|183159942|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633353|NCT04716010|183159942|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633354|NCT04716010|183159942|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633355|NCT04716010|183159942|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633356|NCT04716010|183159943|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633357|NCT04716010|183159943|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91667123|NCT03086135|183228069|SUPERIORITY|||||||0.0024|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0024
91667124|NCT03086135|183228069|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
91667125|NCT03086135|183228069|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
91667126|NCT03086135|183228069|SUPERIORITY|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.85
91667127|NCT03086135|183228069|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.||||1.0
91667128|NCT03086135|183228069|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.56
91667129|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667130|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667131|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91484405|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|-0.1|||||TWO_SIDED|95.0|-8.0|4.3|||||Muscle aches within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.3|-8.0|
91792495|NCT04761627|183462689|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geomtric LS Means Ratio|0.9806|||||TWO_SIDED|90.0|0.8916|1.0785|||||Ctrough,ss at Week 52: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0785|0.8916|
91792496|NCT04761627|183462690|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean difference|0.07|||||TWO_SIDED|90.0|-2.62|2.77|||||Mean difference in PASI percent improvement from baseline at Week 64: Switching group - Continued-use group|Multiple imputation was applied for the point estimate and CI of the mean difference between the switching and continued-use groups. Missing PASI scores at the week 64 visit were imputed by MI.||2.77|-2.62|
91792497|NCT04761627|183462691|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-5.7|6.2|||||Response difference in PASI 75 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||6.2|-5.7|
91484406|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|1.7|||||TWO_SIDED|95.0|-4.1|4.4|||||Chills within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.4|-4.1|
91633358|NCT04716010|183159943|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633359|NCT04716010|183159943|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633360|NCT04716010|183159943|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633361|NCT04716010|183159943|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633362|NCT04716010|183159944|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633363|NCT04716010|183159944|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633364|NCT04716010|183159944|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484407|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|3.2|||||TWO_SIDED|95.0|-6.5|9.8|||||Decreased activity (tiredness) within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||9.8|-6.5|
91484408|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|3.5|||||TWO_SIDED|95.0|-7.8|11.9|||||Headache within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.9|-7.8|
91484409|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|12.3|||||TWO_SIDED|95.0|-1.6|24.4|||||Any symptom within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||24.4|-1.6|
91484410|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|1.2|||||TWO_SIDED|95.0|-4.5|3.9|||||Fever \>100 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.9|-4.5|
91633365|NCT04716010|183159944|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633366|NCT04716010|183159944|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633367|NCT04716010|183159944|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633368|NCT04716010|183159945|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633369|NCT04716010|183159945|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633370|NCT04716010|183159945|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633371|NCT04716010|183159945|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633372|NCT04716010|183159945|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633373|NCT04716010|183159945|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633374|NCT04716010|183159946|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633375|NCT04716010|183159946|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633376|NCT04716010|183159946|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633377|NCT04716010|183159946|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633378|NCT04716010|183159946|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633379|NCT04716010|183159946|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633380|NCT04716010|183159947|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633381|NCT04716010|183159947|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633382|NCT04716010|183159947|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484411|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>=101 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
91484412|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
91484413|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
91484414|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|9.7|||||TWO_SIDED|95.0|-1.8|18.6|||||Runny nose within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||18.6|-1.8|
91484415|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Sore throat within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
91484416|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-8.6|5.7|||||Cough within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.7|-8.6|
91484417|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||Vomiting within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||2.6|-5.3|
91484418|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-7.8|4.8|||||Muscle aches within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.8|-7.8|
91633383|NCT04716010|183159947|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484419|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|2.5|||||TWO_SIDED|95.0|-3.3|5.5|||||Chills within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.5|-3.3|
91484420|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Decreased activity (tiredness) within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
91484421|NCT01859143|182842632|SUPERIORITY_OR_OTHER||Percent difference|3.0|||||TWO_SIDED|95.0|-8.7|12.0|||||Headache within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||12.0|-8.7|
91525814|NCT02567825|182927153|SUPERIORITY|||||||0.48|||||||Chi-squared|||"Null hypothesis: There is no difference between the two groups in the proportion of children completing the study with 0, 1 or 2, 3 or 4, greater than or equal to 5 episodes of AOM.~."||||0.48
91633384|NCT04716010|183159947|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91714393|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9505||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9505
91484422|NCT00760214|182842636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-11.04|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-5.78|-11.04|<.001
91484423|NCT00760214|182842636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.03|||<|0.001|TWO_SIDED|95.0|-11.66|-6.39||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-6.39|-11.66|<.001
91484424|NCT00760214|182842637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31|||<|0.001|TWO_SIDED|95.0|-6.85|-3.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.78|-6.85|<.001
91484425|NCT00760214|182842637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-7.21|-4.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.12|-7.21|<.001
91525815|NCT02567825|182927154|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.58|0.92|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children experiencing treatment failure.||0.92|0.58|
91633385|NCT04716010|183159947|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633386|NCT04716010|183159948|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91484426|NCT00760214|182842638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.82|||<|0.001|TWO_SIDED|95.0|-7.64|-2.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.01|-7.64|<.001
91484427|NCT00760214|182842638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.47||||0.002|TWO_SIDED|95.0|-7.27|-1.66||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.66|-7.27|0.002
91633387|NCT04716010|183159948|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633388|NCT04716010|183159948|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91714394|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6877||95.0|-0.7|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-0.7|0.6877
91714395|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1271||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1271
91714396|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9136||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9136
91714397|NCT00676403|183320244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4072||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.4072
91714398|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|10.68||0.186||95.0|-35.2|6.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-35.2|0.1860
91714399|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|10.54||0.653||95.0|-25.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-25.5|0.6530
91792498|NCT04761627|183462692|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-7.4|7.8|||||Response difference in PASI 100 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||7.8|-7.4|
91484428|NCT00760214|182842639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.77||||0.003|TWO_SIDED|95.0|-4.61|-0.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.94|-4.61|0.003
91484429|NCT00760214|182842639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06||||0.001|TWO_SIDED|95.0|-4.89|-1.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.24|-4.89|0.001
91792499|NCT04761627|183462694|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Risk Difference (RD)|-0.48|||||TWO_SIDED|90.0|-4.17|3.1|||||Switching group - continued-use group|Risk difference for any EOI: risk difference and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.||3.10|-4.17|
91525816|NCT02567825|182927155|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the time to the first episode of AOM.||0.90|0.52|
91633389|NCT04716010|183159948|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484430|NCT00760214|182842640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.017|TWO_SIDED|95.0|-6.87|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-6.87|0.017
91484431|NCT00760214|182842640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||0.029|TWO_SIDED|95.0|-6.5|-0.36||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.36|-6.50|0.029
91484432|NCT00760214|182842641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.052|TWO_SIDED|95.0|-4.15|0.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||0.02|-4.15|0.052
91633390|NCT04716010|183159948|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484433|NCT00760214|182842641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.022|TWO_SIDED|95.0|-4.49|-0.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.35|-4.49|0.022
91484434|NCT00760214|182842642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.003|TWO_SIDED|95.0|-7.46|-1.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.59|-7.46|0.003
91633391|NCT04716010|183159948|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633392|NCT04716010|183159949|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633393|NCT04716010|183159949|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91714400|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|10.79||0.6263||95.0|-26.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-26.5|0.6263
91714401|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|10.63||0.4266||95.0|-29.4|12.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-29.4|0.4266
91484435|NCT00760214|182842642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.004|TWO_SIDED|95.0|-7.18|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.35|-7.18|0.004
91714402|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|10.54||0.4023||95.0|-29.6|11.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-29.6|0.4023
91633394|NCT04716010|183159949|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633395|NCT04716010|183159949|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633396|NCT04716010|183159949|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633397|NCT04716010|183159949|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633398|NCT04716010|183159950|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633399|NCT04716010|183159950|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633400|NCT04716010|183159950|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633401|NCT04716010|183159950|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633402|NCT04716010|183159950|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91484436|NCT00760214|182842643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.008|TWO_SIDED|95.0|-4.6|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-4.60|0.008
91484437|NCT00760214|182842643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.98||||0.003|TWO_SIDED|95.0|-4.93|-1.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.04|-4.93|0.003
91633403|NCT04716010|183159950|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633404|NCT04716010|183159951|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633405|NCT04716010|183159951|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633406|NCT04716010|183159951|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633407|NCT04716010|183159951|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633408|NCT04716010|183159951|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633409|NCT04716010|183159951|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633410|NCT04716010|183159952|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633411|NCT04716010|183159952|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633412|NCT04716010|183159952|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633413|NCT04716010|183159952|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633414|NCT04716010|183159952|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633415|NCT04716010|183159952|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633416|NCT04716010|183159953|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633417|NCT04716010|183159953|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633418|NCT04716010|183159953|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633419|NCT04716010|183159953|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633420|NCT04716010|183159953|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633421|NCT04716010|183159953|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633422|NCT04716010|183159954|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633423|NCT04716010|183159954|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633424|NCT04716010|183159954|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91484438|NCT00760214|182842644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-9.12|-2.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.77|-9.12|<.001
91633425|NCT04716010|183159954|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633426|NCT04716010|183159954|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
91633427|NCT04716010|183159954|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
91633428|NCT01708915|183159995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.362|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.699|-1.025||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-1.025|-1.699|<0.0001
91484439|NCT00760214|182842644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||<|0.001|TWO_SIDED|95.0|-8.96|-2.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.67|-8.96|<.001
91484440|NCT00760214|182842645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01||||0.006|TWO_SIDED|95.0|-5.15|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.88|-5.15|0.006
91484441|NCT00760214|182842645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||<|0.001|TWO_SIDED|95.0|-5.89|-1.65||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.65|-5.89|<.001
91633429|NCT01708915|183159995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983|STANDARD_ERROR_OF_MEAN|0.173|<|0.0001|TWO_SIDED|95.0|-1.324|-0.642||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.642|-1.324|<0.0001
91633430|NCT01708915|183159995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.195||0.4171||95.0|-0.541|0.225||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.225|-0.541|0.4171
91667132|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667133|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667134|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667135|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91484442|NCT00760214|182842646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.87|||<|0.001|TWO_SIDED|95.0|-12.15|-5.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-5.60|-12.15|<.001
91484443|NCT00760214|182842646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.46|-4.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.95|-11.46|<.001
91633431|NCT01708915|183159996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.049|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.305|-0.793||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.793|-1.305|<0.0001
91633432|NCT01708915|183159996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.731|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001||95.0|-1.003|-0.459||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.459|-1.003|<0.0001
91484444|NCT00760214|182842647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.68|||<|0.001|TWO_SIDED|95.0|-8.19|-3.17||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.17|-8.19|<.001
91633433|NCT01708915|183159996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.152||0.7037||95.0|-0.356|0.241||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.241|-0.356|0.7037
91667136|NCT03086135|183228070|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
91667137|NCT03086135|183228071|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667138|NCT03086135|183228071|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667139|NCT03086135|183228071|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667140|NCT03086135|183228071|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91484445|NCT00760214|182842647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32|||<|0.001|TWO_SIDED|95.0|-7.81|-2.82||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.82|-7.81|<.001
91667141|NCT03086135|183228072|SUPERIORITY|||||||0.025|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.025
91667142|NCT03086135|183228072|SUPERIORITY|||||||0.096|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.096
91667143|NCT03086135|183228072|SUPERIORITY|||||||0.015|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.015
91667144|NCT03086135|183228072|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.67
91667145|NCT03086135|183228072|SUPERIORITY|||||||0.73|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.73
91667146|NCT03086135|183228072|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.019
91667147|NCT03086135|183228072|SUPERIORITY|||||||0.0046|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.0046
91714403|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.77||0.1041||95.0|-38.8|3.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.6|-38.8|0.1041
91484446|NCT00700570|182842650|SUPERIORITY_OR_OTHER|||||||0.1341|TWO_SIDED||||||Log Rank|||||||0.1341
91484447|NCT00700570|182842652|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.0010
91484448|NCT03875768|182842761|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.72||0.89|TWO_SIDED|95.0|-0.44|0.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size is 0.5. The investigators hypothesize that the intervention will lead to an increase in average DASH score of 2 units. The investigators used a standard deviation for 2 units for both intervention and attention control groups since higher variability may be observed with a bigger sample size than the pilot study.||0.50|-0.44|0.89
91484449|NCT03875768|182842762|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|13.0||0.26|TWO_SIDED|95.0|-5.3|1.4||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in systolic blood pressure (SBP) between intervention and control group is 0.6 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.4|-5.3|0.26
91667148|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
91527832|NCT06173570|182930688|SUPERIORITY||Mean Difference (Net)|-6.06||||0.276|TWO_SIDED|95.0|-16.96|4.84|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||4.84|-16.96|0.276
91667149|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667150|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667151|NCT03086135|183228072|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.019
91667152|NCT03086135|183228072|SUPERIORITY|||||||0.04|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.040
91667153|NCT03086135|183228072|SUPERIORITY|||||||0.037|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.037
91667154|NCT03086135|183228072|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.67
91667155|NCT03086135|183228072|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.34
91667156|NCT03086135|183228072|SUPERIORITY|||||||0.0048|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0048
91667157|NCT03086135|183228072|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0008
91667158|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667159|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667160|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667161|NCT03086135|183228072|SUPERIORITY|||||||0.1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.10
91667162|NCT03086135|183228072|SUPERIORITY|||||||0.0007|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0007
91667163|NCT03086135|183228072|SUPERIORITY|||||||0.0003|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0003
91667164|NCT03086135|183228072|SUPERIORITY|||||||0.11|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.11
91667165|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667166|NCT03086135|183228072|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0001
91667167|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667168|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667169|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667170|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667171|NCT03086135|183228072|SUPERIORITY|||||||0.8|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.80
91484450|NCT03875768|182842763|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|8.3||0.39|TWO_SIDED|95.0|-3.1|1.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in diastolic blood pressure (DBP) between intervention and control group is 0.75 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.2|-3.1|0.39
91667172|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667173|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667174|NCT03086135|183228072|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.0010
91667175|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667176|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667177|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667178|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667179|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667180|NCT03086135|183228072|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
91667181|NCT03086135|183228073|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.51
91667182|NCT03086135|183228073|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.021
91667183|NCT03086135|183228073|SUPERIORITY|||||||0.29|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.29
91667184|NCT03086135|183228073|SUPERIORITY|||||||0.18|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.18
91667185|NCT03086135|183228073|SUPERIORITY|||||||0.017|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.017
91484451|NCT01925274|182842766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.71||||0.164|TWO_SIDED|95.0|-83.4|12.0|||Chi-squared|||||12.0|-83.4|0.164
91633434|NCT01708915|183159997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.655|STANDARD_ERROR_OF_MEAN|0.208|<|0.0001||95.0|-2.064|-1.247|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-1.247|-2.064|<0.0001
91633435|NCT01708915|183159997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.169|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001||95.0|-1.578|-0.759|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.759|-1.578|<0.0001
91633436|NCT01708915|183159997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.209||0.0259||95.0|-0.875|-0.056|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.056|-0.875|0.0259
91633437|NCT01708915|183159998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.385|||<|0.0001||95.0|4.943|11.032|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||11.032|4.943|<0.0001
91633438|NCT01708915|183159998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62|||<|0.0001||95.0|2.469|5.308|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||5.308|2.469|<0.0001
91633439|NCT01708915|183159998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.594||||0.0129||95.0|1.104|2.303|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||2.303|1.104|0.0129
91633440|NCT01045551|183160017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|t-test, 2 sided|||||||0.98
91633441|NCT01045551|183160018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_DEVIATION|0.9024|||TWO_SIDED|||||||||||||
91633442|NCT02313506|183160022|SUPERIORITY||Mean Difference (Net)|-31.1||||0.02|TWO_SIDED|95.0|-56.6|-5.7||No adjustment was made for multiple comparisons because Type II error is a greater concern than Type I error in feasibility studies.|ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.||-5.7|-56.6|0.02
91633443|NCT02313506|183160022|SUPERIORITY||Mean Difference (Net)|4.6||||0.71|TWO_SIDED|95.0|-19.6|28.9|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.||28.9|-19.6|0.71
91633444|NCT02313506|183160022|SUPERIORITY||Mean Difference (Net)|-11.0||||0.29|TWO_SIDED|95.0|-31.1|9.1|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.||9.1|-31.1|0.29
91484452|NCT05896748|182842875|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.901|0.998|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.998|0.901|
91484453|NCT05896748|182842875|OTHER||Ratio of geometric least square mean|0.935|||||TWO_SIDED|90.0|0.877|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.995|0.877|
91484454|NCT05896748|182842875|OTHER||Ratio of geometric least square mean|0.934|||||TWO_SIDED|90.0|0.872|1.0|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||1.000|0.872|
91633445|NCT00537810|183160087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Chi-squared|df=3||Post-treatment||||0.60
91633446|NCT00537810|183160087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Chi-squared|df=3||6 month follow up||||0.13
91633447|NCT00537810|183160087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|df=3||12 month follow up||||0.29
91633448|NCT03860181|183160104|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 1's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.896|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 215||||||0.896
91633449|NCT03860181|183160104|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 2's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.612|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 210||||||0.612
91484455|NCT05896748|182842875|OTHER||Ratio of geometric least square mean|0.999|||||TWO_SIDED|90.0|0.943|1.059|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within CAB||1.059|0.943|
91484456|NCT05896748|182842876|OTHER||Ratio of geometric least square mean|1.002|||||TWO_SIDED|90.0|0.952|1.056|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.056|0.952|
91633450|NCT02422186|183160161|SUPERIORITY||Difference of Least Square (LS) Means|-3.6|||=|0.059|TWO_SIDED|95.0|-7.2|0.07|||Mixed Model for Repeated Measures|||||0.07|-7.20|=0.059
91633451|NCT02422186|183160162|OTHER||Least Square (LS) Mean Difference|-3.6|||=|0.052|TWO_SIDED|95.0|-7.16|-0.03|||ANCOVA|||||-0.03|-7.16|=0.052
91633452|NCT05281094|183160169|SUPERIORITY||Vaccine Efficacy|12.98|||||TWO_SIDED|95.0|-52.51|50.35|||||. Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||50.35|-52.51|
91667186|NCT03086135|183228073|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.16
91633453|NCT05281094|183160170|SUPERIORITY||Vaccine Efficacy|17.02|||||TWO_SIDED|95.0|-24.52|44.7|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1||44.70|-24.52|
91633454|NCT05281094|183160171|SUPERIORITY||Vaccine Efficacy|13.91|||||TWO_SIDED|95.0|-34.7|44.98|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||44.98|-34.70|
91633455|NCT05281094|183160172|SUPERIORITY||Vaccine Efficacy|-6.37|||||TWO_SIDED|95.0|-45.04|22.0|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||22.00|-45.04|
91633456|NCT04223778|183160200|NON_INFERIORITY|Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.|Estimated Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-3.44|-0.34|||Miettinen and Nurminen|The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.||||-0.34|-3.44|<.001
91633457|NCT04223778|183160201|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|9.8|||||TWO_SIDED|95.0|3.3|16.3|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||16.3|3.3|
91633458|NCT04223778|183160202|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.8|||||TWO_SIDED|95.0|0.2|4.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||4.0|0.2|
91633459|NCT04223778|183160203|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.3|||||TWO_SIDED|95.0|-3.28|3.9|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<40 copies/mL||3.90|-3.28|
91633460|NCT04223778|183160203|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.89|||||TWO_SIDED|95.0|-2.58|4.43|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<50 copies/mL||4.43|-2.58|
91633461|NCT04223778|183160206|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-8.9|||||TWO_SIDED|95.0|-13.4|-4.5|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||-4.5|-13.4|
91633462|NCT04223778|183160211|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-19.75|||||TWO_SIDED|95.0|-33.07|-6.44|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Cholesterol||-6.44|-33.07|
91633463|NCT04223778|183160211|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.35|||||TWO_SIDED|95.0|-6.55|3.84|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting HDL Cholesterol||3.84|-6.55|
91633464|NCT04223778|183160211|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-13.94|||||TWO_SIDED|95.0|-24.69|-3.2|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting LDL Cholesterol||-3.20|-24.69|
91633465|NCT04223778|183160211|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-17.74|||||TWO_SIDED|95.0|-30.02|-5.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Non-HDL Cholesterol||-5.46|-30.02|
91484457|NCT05896748|182842876|OTHER||Ratio of geometric least square mean|0.961|||||TWO_SIDED|90.0|0.921|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.002|0.921|
91633466|NCT04223778|183160211|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-21.28|||||TWO_SIDED|95.0|-45.51|2.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Triglycerides||2.96|-45.51|
91633467|NCT04223778|183160212|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.17|||||TWO_SIDED|95.0|-10.43|2.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||2.09|-10.43|
91633468|NCT04223778|183160212|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.81|||||TWO_SIDED|95.0|-1.46|3.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||3.09|-1.46|
91484458|NCT05896748|182842876|OTHER||Ratio of geometric least square mean|0.928|||||TWO_SIDED|90.0|0.885|0.973|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||0.973|0.885|
91484459|NCT05896748|182842876|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.955|1.053|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within RPV||1.053|0.955|
91633469|NCT04223778|183160212|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.87|||||TWO_SIDED|95.0|-9.47|1.74|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||1.74|-9.47|
91633470|NCT04223778|183160212|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.92|||||TWO_SIDED|95.0|-11.21|1.38|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||1.38|-11.21|
91633471|NCT04223778|183160212|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.65|||||TWO_SIDED|95.0|-16.14|19.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||19.43|-16.14|
91633472|NCT04223778|183160213|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.05|||||TWO_SIDED|95.0|-7.6|9.7|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||9.70|-7.60|
91633473|NCT04223778|183160213|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.16|||||TWO_SIDED|95.0|-6.37|0.05|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.05|-6.37|
91633474|NCT04223778|183160213|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|4.38|||||TWO_SIDED|95.0|-2.27|11.03|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||11.03|-2.27|
91633475|NCT04223778|183160213|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.63|||||TWO_SIDED|95.0|-3.93|11.19|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||11.19|-3.93|
91633476|NCT04223778|183160213|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.79|||||TWO_SIDED|95.0|-15.89|12.31|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||12.31|-15.89|
91633477|NCT04223778|183160214|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.41|||||TWO_SIDED|95.0|-32.05|-4.76|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||-4.76|-32.05|
91633478|NCT04223778|183160214|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.01|||||TWO_SIDED|95.0|-5.06|5.08|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||5.08|-5.06|
91633479|NCT04223778|183160214|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-14.12|||||TWO_SIDED|95.0|-25.81|-2.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||-2.43|-25.81|
91633480|NCT04223778|183160214|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.23|||||TWO_SIDED|95.0|-30.45|-6.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||-6.00|-30.45|
91633481|NCT04223778|183160214|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-27.79|||||TWO_SIDED|95.0|-51.08|-4.49|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||-4.49|-51.08|
91633482|NCT04223778|183160214|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-14.12||||0.0094|TWO_SIDED|95.0|-27.56|-0.68||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-0.68|-27.56|0.0094
91633483|NCT04223778|183160214|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-18.23||||0.0021|TWO_SIDED|95.0|-32.28|-4.17||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-4.17|-32.28|0.0021
91633484|NCT04223778|183160215|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.04|||||TWO_SIDED|95.0|-6.26|6.18|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||6.18|-6.26|
91633485|NCT04223778|183160215|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.35|||||TWO_SIDED|95.0|-1.84|2.54|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||2.54|-1.84|
91633486|NCT04223778|183160215|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.64|||||TWO_SIDED|95.0|-4.83|6.11|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||6.11|-4.83|
91633487|NCT04223778|183160215|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.49|||||TWO_SIDED|95.0|-6.81|5.83|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||5.83|-6.81|
91633488|NCT04223778|183160215|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-5.45|||||TWO_SIDED|95.0|-20.46|9.57|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||9.57|-20.46|
91667187|NCT03086135|183228073|SUPERIORITY|||||||0.0051|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.0051
91667188|NCT03086135|183228073|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.021
91667189|NCT03086135|183228073|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.56
91667190|NCT03086135|183228073|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
91667191|NCT03086135|183228073|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
91667192|NCT03086135|183228073|SUPERIORITY|||||||0.041|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||0.041
91667193|NCT03086135|183228074|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.||||<0.0001
91667194|NCT03086135|183228074|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.||||<0.0001
91667195|NCT03086135|183228074|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.||||<0.0001
91667196|NCT03086135|183228074|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.||||<0.0001
91667197|NCT01023061|183228086|SUPERIORITY||Median Difference (Final Values)|0.74|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.01
91667198|NCT00202839|183228149|SUPERIORITY_OR_OTHER|||||||0.1651||95.0|||||Chi-squared|||||||0.1651
91667199|NCT01456962|183228257|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
91484460|NCT05896748|182842877|OTHER||Ratio of geometric least square mean|0.942|||||TWO_SIDED|90.0|0.897|0.99|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.990|0.897|
91667200|NCT01456962|183228257|SUPERIORITY_OR_OTHER||% change in CD4+:CD8+ T cells ratio|-9.5||||0.4|TWO_SIDED|95.0|-27.3|12.0|||Regression, Linear|Adjusted for treatment group and time on antiretroviral therapy|Change based on a 1 log unit increase in genital:plasma drug ratio|Null hypothesis: Higher genital to plasma antiretroviral drug ratios are not associated with higher cervical CD4+:CD8+ T cell ratios.||12|-27.3|0.4
91667201|NCT04684485|183228303|SUPERIORITY|||||||0.1966|||||||Cochran-Mantel-Haenszel|||||||0.1966
91667202|NCT04684485|183228303|SUPERIORITY|||||||0.5438|||||||Cochran-Mantel-Haenszel|||||||0.5438
91667203|NCT04684485|183228303|SUPERIORITY|||||||0.3713|||||||Cochran-Mantel-Haenszel|||||||0.3713
91667204|NCT04684485|183228304|SUPERIORITY|||||||0.4564|||||||Cochran-Mantel-Haenszel|||||||0.4564
91667205|NCT04684485|183228304|SUPERIORITY|||||||0.2515|||||||Cochran-Mantel-Haenszel|||||||0.2515
91667206|NCT04684485|183228304|SUPERIORITY|||||||0.5055|||||||Cochran-Mantel-Haenszel|||||||0.5055
91667207|NCT03405363|183228357|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.2|||||TWO_SIDED|95.0|0.98|1.47|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|||1.47|0.98|
91667208|NCT03405363|183228358|OTHER||Adjusted Incidence Rate Ratio|1.83|||||TWO_SIDED|95.0|0.9|3.74|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||3.74|0.90|
91667209|NCT03405363|183228359|OTHER||Adjusted Incidence Rate Ratio|1.3|||||TWO_SIDED|95.0|0.71|2.36|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||2.36|0.71|
91667210|NCT03405363|183228360|OTHER||Adjusted Incidence Rate Ratio|1.22|||||TWO_SIDED|95.0|0.79|1.87|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.87|0.79|
91667211|NCT03405363|183228361|OTHER||Adjusted Incidence Rate Ratio|1.0|||||TWO_SIDED|95.0|0.64|1.56|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.56|0.64|
91667212|NCT03405363|183228362|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.63|||||TWO_SIDED|95.0|1.44|1.84|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|Analysis was based on Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry.||1.84|1.44|
91667213|NCT03405363|183228362|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.48|||||TWO_SIDED|95.0|1.23|1.78|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|"Analysis based on post-hoc population 1.~Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications, fixed-dose combinations of Short-Acting Beta2- Agonist and Short-Acting Muscarinic Antagonist and systemic antibacterials. COPD severity, number of: all-cause hospitalisations 365 and 180 days, COPD exacerbations 180 and 90 days, COPD hospitalisations 180 and 90 days, and COPD exacerbations 90 days before index date."||1.78|1.23|
91667214|NCT03405363|183228362|OTHER|No formal hypotheses were tested.|Adjusted Incidende Rate Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|Analysis based on post-hoc population 2. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications. COPD severity, number of all-cause hospitalisations 180 days, COPD exacerbations 180 days before cohort entry.||1.64|0.97|
91667215|NCT01328782|183228368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.074||95.0|1.4|2.94|||ANOVA|||||2.94|1.40|0.074
91667216|NCT01328782|183228368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.556||||0.556||95.0|-1.12|2.08|||ANOVA|||||2.08|-1.12|0.556
91667217|NCT01328782|183228368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.244||95.0|-0.64|2.49|||ANOVA|||||2.49|-0.64|0.244
91667218|NCT01328782|183228369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.014|TWO_SIDED|95.0|0.38|3.25|||ANOVA|||||3.25|0.38|0.014
91667219|NCT01328782|183228369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.832||95.0|-1.3|1.61|||ANOVA|||||1.61|-1.30|0.832
91667220|NCT01328782|183228369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.027||95.0|0.2|3.12|||ANOVA|||||3.12|0.20|0.027
91667221|NCT01328782|183228370|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
91633489|NCT04223778|183160215|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|0.64||||0.4093|TWO_SIDED|95.0|-5.63|6.9||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.90|-5.63|0.4093
91633490|NCT04223778|183160215|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-0.49||||0.4397|TWO_SIDED|95.0|-7.72|6.75||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.75|-7.72|0.4397
91633491|NCT04223778|183160216|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.31|||||TWO_SIDED|95.0|-5.54|10.17|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||10.17|-5.54|
91633492|NCT04223778|183160216|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-2.52|||||TWO_SIDED|95.0|-5.69|0.65|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.65|-5.69|
91633493|NCT04223778|183160216|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.34|||||TWO_SIDED|95.0|-3.73|8.42|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||8.42|-3.73|
91633494|NCT04223778|183160216|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.97|||||TWO_SIDED|95.0|-2.63|10.56|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||10.56|-2.63|
91667222|NCT01328782|183228370|SUPERIORITY_OR_OTHER|||||||0.3767||95.0|||||Log Rank|||||||0.3767
91667223|NCT01328782|183228370|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
91667224|NCT01328782|183228371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.008||95.0|0.008|0.076|||ANOVA|||||0.076|0.008|0.008
91667225|NCT01328782|183228371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.078||95.0|-0.004|0.066|||ANOVA|||||0.066|-0.004|0.078
91667226|NCT01328782|183228371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.5321||95.0|-0.024|0.045|||ANOVA|||||0.045|-0.024|0.5321
91667227|NCT01328782|183228372|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
91667228|NCT01328782|183228372|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
91667229|NCT01328782|183228372|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Chi-squared|||||||0.499
91667230|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.252|0.309|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.309|0.252|<0.0001
91667231|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.143|0.087|<0.0001
91667232|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.082|0.139|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.139|0.082|<0.0001
91667233|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.249|0.306|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.306|0.249|<0.0001
91667234|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.083|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.140|0.083|<0.0001
91484461|NCT05896748|182842877|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.86|0.965|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.965|0.860|
91633495|NCT04223778|183160216|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|10.5|||||TWO_SIDED|95.0|-3.97|24.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||24.96|-3.97|
91633496|NCT04223778|183160217|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.44|||||TWO_SIDED|95.0|-0.59|1.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|||1.46|-0.59|
91633497|NCT05325333|183160222|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with DLD||||||0.567|||||||LSD test|||||||0.567
91633498|NCT05325333|183160222|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with TD||||||0.003|||||||LSD test|||||||0.003
91633499|NCT05325333|183160223|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with DLD||||||0.187|||||||LSD test|||||||0.187
91633500|NCT05325333|183160223|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with TD||||||0.256|||||||LSD test|||||||0.256
91633501|NCT05325333|183160224|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for DLD||||||0.747|||||||LSD test|||||||0.747
91633502|NCT05325333|183160224|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for TD||||||0.031|||||||LSD test|||||||0.031
91633503|NCT05325333|183160225|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for DLD||||||0.061|||||||LSD test|||||||0.061
91633504|NCT05325333|183160225|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for TD||||||0.747|||||||LSD test|||||||0.747
91633505|NCT05325333|183160226|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for DLD||||||0.026|||||||LSD test|||||||0.026
91667235|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.096|0.152|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.152|0.096|<0.0001
91484462|NCT05896748|182842877|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.857|0.966|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.966|0.857|
91633506|NCT05325333|183160226|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for TD||||||0.72|||||||LSD test|||||||0.720
91633507|NCT05325333|183160227|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
91633508|NCT05325333|183160228|SUPERIORITY|||||||0.673|||||||t-test, 2 sided|||||||0.673
91633509|NCT01265719|183160262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1126|TWO_SIDED|95.0|-0.09|0.74|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|\<5 years||0.74|-0.09|0.1126
91633510|NCT01265719|183160262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.484|TWO_SIDED|95.0|-0.12|0.06|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|5 to \<18 years||0.06|-0.12|0.4840
91633511|NCT01265719|183160264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.3||0.902|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|\<5 years||0.56|-0.63|0.9020
91633512|NCT01265719|183160264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8826|TWO_SIDED|95.0|-0.37|0.43|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|5 to \<18 years||0.43|-0.37|0.8826
91633513|NCT01265719|183160265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62|STANDARD_ERROR_OF_MEAN|1.25||0.2003|TWO_SIDED|95.0|-4.13|0.89|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|\<5 years||0.89|-4.13|0.2003
91633514|NCT01265719|183160265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.75||0.894|TWO_SIDED|95.0|-1.59|1.39|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP \<21mmHg at Baseline)||1.39|-1.59|0.8940
91633515|NCT01265719|183160265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.41||0.0184|TWO_SIDED|95.0|-11.95|-1.36|||ANCOVA|The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).|Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP ≥21mmHg at Baseline)||-1.36|-11.95|0.0184
91633516|NCT01265719|183160266|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.0|||>|0.999|TWO_SIDED|95.0|-13.97|15.9|||Fisher Exact|||||15.90|-13.97|>0.999
91633517|NCT01265719|183160267|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.4|||>|0.999|TWO_SIDED|95.0|-15.32|14.55|||Fisher Exact|||||14.55|-15.32|>0.999
91484463|NCT05896748|182842877|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.938|1.074|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within CAB||1.074|0.938|
91714404|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|10.6||0.5084||95.0|-27.9|13.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.8|-27.9|0.5084
91792500|NCT01634178|183462696|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% confidence interval (CI) of the geometric least squares (LS) mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric Least Squares Means|98.3|||||TWO_SIDED|90.0|90.7|106.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||106.6|90.7|
91792501|NCT01634178|183462698|OTHER||Median Difference|0.75||||0.0077|TWO_SIDED|90.0|0.25|1.25|||Wilcoxon signed-rank test||Median difference (Fed - Fasted) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.25|0.25|0.0077
91633518|NCT01265719|183160268|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.2|||>|0.999|TWO_SIDED|95.0|-13.78|16.09|||Fisher Exact|||||16.09|-13.78|>0.999
91633519|NCT01265719|183160270|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.6||||0.6414|TWO_SIDED|95.0|-13.39|16.48|||Fisher Exact|||||16.48|-13.39|0.6414
91633520|NCT01265719|183160271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.52||0.2437|TWO_SIDED|95.0|-0.43|1.65|||ANCOVA||Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|\<5 years||1.65|-0.43|0.2437
91633521|NCT01265719|183160271|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.32||0.5199|TWO_SIDED|95.0|-0.85|0.43|||ANCOVA||Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|5 to \<18 years||0.43|-0.85|0.5199
91633522|NCT01265719|183160272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.68|STANDARD_ERROR_OF_MEAN|15.54||0.8643|TWO_SIDED|95.0|-34.3|28.94|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|\<5 years||28.94|-34.30|0.8643
91633523|NCT01265719|183160272|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|4.87||0.8591|TWO_SIDED|95.0|-10.54|8.8|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|5 to \<18 years||8.80|-10.54|0.8591
91633524|NCT01265719|183160273|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.5||||0.2413|TWO_SIDED|95.0|-10.49|19.36|||Fisher Exact|||||19.36|-10.49|0.2413
91633525|NCT00303602|183160276|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.428
91633526|NCT00303602|183160276|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.859
91633527|NCT00303602|183160276|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.885
91633528|NCT00303602|183160276|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.784
91633529|NCT00303602|183160276|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.465
91633530|NCT00303602|183160277|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.19||||0.442||95.0|-0.67|0.3|||ANCOVA||Change = Endpoint minus baseline|||0.30|-0.67|0.442
91633531|NCT00303602|183160278|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.32||||0.328||95.0|-0.95|0.32|||ANCOVA||Change = Endpoint minus baseline|||0.32|-0.95|0.328
91633532|NCT00303602|183160279|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
91633533|NCT00303602|183160280|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|0.1||||0.914||95.0|-1.65|1.84|||ANCOVA||Change = endpoint minus baseline|||1.84|-1.65|0.914
91633534|NCT00303602|183160281|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Up to Week 16 p-value|Fisher Exact|||||||0.325
91633535|NCT00303602|183160283|SUPERIORITY_OR_OTHER|||||||0.344||95.0|||||Mixed Models Analysis|||||||0.344
91633536|NCT00303602|183160284|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Systolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.708
91633537|NCT00303602|183160284|SUPERIORITY_OR_OTHER|||||||0.453||95.0||||Diastolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.453
91633538|NCT00303602|183160285|SUPERIORITY_OR_OTHER|||||||0.187||95.0||||Total Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.187
91633539|NCT00303602|183160285|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||High-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.163
91633540|NCT00303602|183160285|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Low-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.323
91633541|NCT00303602|183160285|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Triglycerides Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.581
91484464|NCT05896748|182842878|OTHER||Ratio of geometric least square mean|0.938|||||TWO_SIDED|90.0|0.895|0.982|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.982|0.895|
91633542|NCT00303602|183160286|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.227
91792502|NCT01634178|183462699|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% CI of the geometric LS mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric LS Means|112.4|||||TWO_SIDED|90.0|109.3|115.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||115.6|109.3|
91792503|NCT01634178|183462700|OTHER||Ratio of Geometric Least Squares Means|112.0|||||TWO_SIDED|90.0|108.9|115.1|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an ANOVA with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||115.1|108.9|
91484465|NCT05896748|182842878|OTHER||Ratio of geometric least square mean|0.918|||||TWO_SIDED|90.0|0.876|0.963|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.963|0.876|
91633543|NCT00303602|183160287|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.020
91633544|NCT00303602|183160288|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.834
91633545|NCT00303602|183160289|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.||||||0.022
91633546|NCT00303602|183160290|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||Endpoint Metabolic Syndrome p-value|Fisher Exact|||||||0.515
91633547|NCT00303602|183160291|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Mixed Models Analysis|||||||0.118
91633548|NCT00303602|183160292|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Mixed Models Analysis|||||||0.161
91667236|NCT01559116|183228373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.079|0.136|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.136|0.079|<0.0001
91484466|NCT05896748|182842878|OTHER||Ratio of geometric least square mean|0.905|||||TWO_SIDED|90.0|0.861|0.952|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.952|0.861|
91633549|NCT00303602|183160293|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Mixed Models Analysis|||||||0.229
91633550|NCT02442765|183160294|SUPERIORITY||Least Squares Mean Difference|-4.0|||=|0.021|TWO_SIDED|95.0|-7.4|-0.6||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|mixed model repeated measures (MMRM)|||||-0.6|-7.4|=0.021
91633551|NCT02442765|183160294|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.731|TWO_SIDED|95.0|-3.9|2.7||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||2.7|-3.9|=0.731
91633552|NCT02442765|183160294|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.157|TWO_SIDED|95.0|-8.4|1.4||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||1.4|-8.4|=0.157
91633553|NCT02442765|183160294|SUPERIORITY||Least Squares Mean Difference|-3.6|||=|0.15|TWO_SIDED|95.0|-8.4|1.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.3|-8.4|=0.150
91633554|NCT02442765|183160294|SUPERIORITY||MMRM weighted z-statistic|-2.65|||=|0.008|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|Sequential Parallel Comparison Design (SPCD) was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.008
91633555|NCT02442765|183160294|SUPERIORITY||MMRM weighted z-statistic|-1.26|||=|0.208|TWO_SIDED|||||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.208
91633556|NCT02442765|183160295|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.331|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.331
91633557|NCT02442765|183160295|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.4|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.400
91792504|NCT05867342|183462705|OTHER|||||||0.77||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.77
91792505|NCT05867342|183462706|OTHER|||||||0.002||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.002
91792506|NCT05867342|183462707|OTHER|||||||0.126||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.126
91792507|NCT05867342|183462709|OTHER|||||||0.213||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.213
91484467|NCT05896748|182842878|OTHER||Ratio of geometric least square mean|0.937|||||TWO_SIDED|90.0|0.891|0.986|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within RPV||0.986|0.891|
91633558|NCT02442765|183160295|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.014
91633559|NCT02442765|183160295|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.145|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.145
91792508|NCT05867342|183462710|OTHER|||||||0.418||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.418
91667237|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.289|0.349|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.349|0.289|<0.0001
91667238|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.096|0.156|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.156|0.096|<0.0001
91667239|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.089|0.149|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.149|0.089|<0.0001
91667240|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.354|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.354|0.293|<0.0001
91667241|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.161|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.161|0.101|<0.0001
91667242|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.109|0.169|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.169|0.109|<0.0001
91667243|NCT01559116|183228374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.093|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.093|<0.0001
91667244|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.212|0.273|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.273|0.212|<0.0001
91667245|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.074|0.133|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.133|0.074|<0.0001
91667246|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.072|0.132|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.132|0.072|<0.0001
91667247|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.201|0.262|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.262|0.201|<0.0001
91792509|NCT05867342|183462711|OTHER|||||||0.756||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.756
91667248|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.123|0.063|<0.0001
91667249|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.08|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.140|0.080|<0.0001
91667250|NCT01559116|183228375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.061|0.121|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.121|0.061|<0.0001
91667251|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.173|0.241|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.241|0.173|<0.0001
91792510|NCT02524977|183462715|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
91792511|NCT03935399|183462731|SUPERIORITY|Exploratory analysis without power calculation||||||0.83|||||||ANOVA|Repeated measures one factor ANOVA||Exploratory analysis without power calculation||||0.83
91484468|NCT05896748|182842879|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.906|0.983|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.983|0.906|
91667252|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.059|0.126|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.126|0.059|<0.0001
91792512|NCT03935399|183462732|SUPERIORITY|Exploratory analysis without power calculation||||||0.92|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.92
91792513|NCT03935399|183462733|SUPERIORITY|Exploratory analysis without power calculation||||||0.79|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.79
91792514|NCT03935399|183462734|SUPERIORITY|Exploratory analysis without power calculation||||||0.93||||||Exploratory analysis without power calculation|ANOVA|One factor repeated measures ANOVA||||||0.93
91792515|NCT03935399|183462735|SUPERIORITY|Exploratory analysis without power calculation||||||0.89||||||Exploratory analysis without power calculation|ANOVA|Two factor repeated measures ANOVA||||||0.89
91792516|NCT03935399|183462736|SUPERIORITY|Exploratory analysis without power calculation||||||0.83||||||Exploratory analysis without power calculation|ANOVA|Two way repeated measures ANOVA||||||0.83
91792517|NCT03935399|183462737|SUPERIORITY|Exploratory analysis without power caclulation||||||0.57||||||Exploratory analysis without power caclulation|ANOVA|Two way repeated measures ANOVA||||||0.57
91633560|NCT02442765|183160295|SUPERIORITY||SPCD OLS weighted z-statistic|-2.51||||0.012|TWO_SIDED||||||ANCOVA||OLS = ordinary least squares|||||0.012
91633561|NCT02442765|183160295|SUPERIORITY||SPCD OLS weighted z-statistic|-1.66||||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
91633562|NCT02442765|183160296|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.182|TWO_SIDED|95.0|-1.3|0.2||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||0.2|-1.3|=0.182
91633563|NCT02442765|183160296|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.39|TWO_SIDED|95.0|-1.1|0.4||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.4|-1.1|=0.390
91633564|NCT02442765|183160296|SUPERIORITY||Least Squares Mean Difference|0.5|||=|0.462|TWO_SIDED|95.0|-0.8|1.7||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.7|-0.8|=0.462
91633565|NCT02442765|183160296|SUPERIORITY||Least Squares Mean Difference|0.4|||=|0.528|TWO_SIDED|95.0|-0.8|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-0.8|=0.528
91667253|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.045|0.113|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.113|0.045|<0.0001
91667254|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.167|0.235|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.235|0.167|<0.0001
91667255|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.052|0.12|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.120|0.052|<0.0001
91667256|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.067|0.135|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.135|0.067|<0.0001
91667257|NCT01559116|183228376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.039|0.107|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.107|0.039|<0.0001
91633566|NCT02442765|183160296|SUPERIORITY||MMRM weighted z-statistic|-0.39|||=|0.695|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.695
91633567|NCT02442765|183160296|SUPERIORITY||MMRM weighted z-statistic|-0.12|||=|0.904|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.904
91667258|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.305|0.371|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.371|0.305|<0.0001
91667259|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.087|0.153|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.153|0.087|<0.0001
91667260|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.078|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.143|0.078|<0.0001
91792518|NCT01112683|183462738|SUPERIORITY_OR_OTHER|||||||0.403|ONE_SIDED|90.0|||||Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||20 subjects per group were expected to provide 60% power to detect a between-group mean difference of 1.2 correct patterns (change from baseline to week 16) on the Paired Associates Learning and to provide 40% power to detect a between-group mean difference of 1.2 patterns recognized on the Pattern Recognition Memory. A two-sided test at type I error rate of 5% was used. Sample size incorporated an inflation factor of 20% to account for ineligibility of 10% of randomized participants.||||0.403
91792519|NCT01112683|183462739|SUPERIORITY_OR_OTHER|||||||0.371|ONE_SIDED|90.0||||This P-Value refers to the SIB-R Broad independence score.|Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||No power calculations were performed for the secondary measures.||||0.371
91792520|NCT02129777|183462741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.008||||0.925|TWO_SIDED|95.0|-0.162|0.179|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.179|-0.162|0.925
91667261|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.317|0.383|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.383|0.317|<0.0001
91484469|NCT05896748|182842879|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.895|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.995|0.895|
91484470|NCT05896748|182842879|OTHER||Ratio of geometric least square mean|0.933|||||TWO_SIDED|90.0|0.876|0.994|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.994|0.876|
91633568|NCT02442765|183160297|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.247|TWO_SIDED|95.0|-3.2|0.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.8|-3.2|=0.247
91633569|NCT02442765|183160297|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.721|TWO_SIDED|95.0|-2.3|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-2.3|=0.721
91633570|NCT02442765|183160297|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.419|TWO_SIDED|95.0|-4.3|1.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.8|-4.3|=0.419
91633571|NCT02442765|183160297|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.534|TWO_SIDED|95.0|-2.0|3.9||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||3.9|-2.0|=0.534
91633572|NCT02442765|183160297|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
91633573|NCT02442765|183160297|SUPERIORITY||MMRM weighted z-statistic|0.19|||=|0.851|TWO_SIDED||||||ANCOVA|||||||=0.851
91667262|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.098|0.164|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.164|0.098|<0.0001
91667263|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.099|0.165|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.165|0.099|<0.0001
91667264|NCT01559116|183228377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.089|0.155|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.155|0.089|<0.0001
91667265|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.389|0.477|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.477|0.389|<0.0001
91633574|NCT02442765|183160298|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.146|TWO_SIDED|95.0|-1.4|0.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.2|-1.4|=0.146
91633575|NCT02442765|183160298|SUPERIORITY||Least Squares Mean Difference|0.3|||=|0.399|TWO_SIDED|95.0|-0.4|1.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.1|-0.4|=0.399
91667266|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.166|0.253|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.253|0.166|<0.0001
91667267|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.133|0.221|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.221|0.133|<0.0001
91484471|NCT05896748|182842879|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.979|1.105|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within CAB||1.105|0.979|
91667268|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.396|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.352|0.441|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.441|0.352|<0.0001
91667269|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.129|0.217|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.217|0.129|<0.0001
91667270|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.115|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated. is calculated.|||0.203|0.115|<0.0001
91484472|NCT05896748|182842880|OTHER||Ratio of geometric least square mean|0.966|||||TWO_SIDED|90.0|0.932|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||1.002|0.932|
91714405|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|11.1||0.262||95.0|-34.3|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-34.3|0.2620
91714406|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|10.7||0.3347||95.0|-31.4|10.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-31.4|0.3347
91633576|NCT02442765|183160298|SUPERIORITY||Least Squares Mean Difference|0.7|||=|0.283|TWO_SIDED|95.0|-0.6|2.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.0|-0.6|=0.283
91633577|NCT02442765|183160298|SUPERIORITY||Least Squares Mean Difference|1.2|||=|0.065|TWO_SIDED|95.0|-0.1|2.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.5|-0.1|=0.065
91633578|NCT02442765|183160298|SUPERIORITY||MMRM weighted z-statistic|-0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
91633579|NCT02442765|183160298|SUPERIORITY||MMRM weighted z-statistic|1.94|||=|0.052|TWO_SIDED||||||ANCOVA|||||||=0.052
91633580|NCT02442765|183160299|SUPERIORITY||Least Squares Mean Difference|-0.7|||=|0.53|TWO_SIDED|95.0|-2.7|1.4|||ANCOVA|||||1.4|-2.7|=0.530
91633581|NCT02442765|183160299|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.326|TWO_SIDED|95.0|-3.1|1.0|||ANCOVA|||||1.0|-3.1|=0.326
91633582|NCT02442765|183160299|SUPERIORITY||Least Squares Mean Difference|2.5|||=|0.135|TWO_SIDED|95.0|-0.8|5.9|||ANCOVA|||||5.9|-0.8|=0.135
91633583|NCT02442765|183160299|SUPERIORITY||Least Squares Mean Difference|0.2|||=|0.895|TWO_SIDED|95.0|-3.1|3.5|||ANCOVA|||||3.5|-3.1|=0.895
91633584|NCT02442765|183160299|SUPERIORITY||SPCD OLS weighted Z-statistic|0.67|||=|0.502|TWO_SIDED||||||ANCOVA|||||||=0.502
91633585|NCT02442765|183160299|SUPERIORITY||SPCD OLS weighted Z-statistic|-0.58|||=|0.564|TWO_SIDED||||||ANCOVA|||||||=0.564
91792521|NCT02129777|183462741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.162|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.162
91792522|NCT02129777|183462741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.034||||0.671|TWO_SIDED|95.0|-0.187|0.118|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.118|-0.187|0.671
91633586|NCT02442765|183160300|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.061|TWO_SIDED|95.0|-1.6|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.0|-1.6|=0.061
91633587|NCT02442765|183160300|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.4|TWO_SIDED|95.0|-1.1|0.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.5|-1.1|=0.400
91633588|NCT02442765|183160300|SUPERIORITY||Least Squares Mean Difference|-1.1|||=|0.115|TWO_SIDED|95.0|-2.4|0.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.3|-2.4|=0.115
91633589|NCT02442765|183160300|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.264|TWO_SIDED|95.0|-2.1|0.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.6|-2.1|=0.264
91633590|NCT02442765|183160300|SUPERIORITY||MMRM weighted z-statistic|-2.44|||=|0.015|TWO_SIDED||||||ANCOVA|||||||=0.015
91633591|NCT02442765|183160300|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
91633592|NCT02442765|183160301|SUPERIORITY||Least Squares Mean Difference|-3.9|||=|0.05|TWO_SIDED|95.0|-7.8|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||-0.0|-7.8|=0.050
91633593|NCT02442765|183160301|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.412|TWO_SIDED|95.0|-5.4|2.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.2|-5.4|=0.412
91633594|NCT02442765|183160301|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.775|TWO_SIDED|95.0|-7.8|5.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||5.8|-7.8|=0.775
91792523|NCT02129777|183462741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.182|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.182
91714407|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|10.61||0.1142||95.0|-37.7|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-37.7|0.1142
91714408|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|11.06||0.1237||95.0|-38.8|4.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-38.8|0.1237
91714409|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|10.67||0.8302||95.0|-18.7|23.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-18.7|0.8302
91792524|NCT02129777|183462743|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.75||0.435|TWO_SIDED|95.0|-2.1|4.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||4.9|-2.1|0.435
91792525|NCT02129777|183462743|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.74||0.279|TWO_SIDED|95.0|-1.6|5.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||5.4|-1.6|0.279
91792526|NCT02129777|183462743|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.74||0.085|TWO_SIDED|95.0|-0.4|6.5|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.5|-0.4|0.085
91484473|NCT05896748|182842880|OTHER||Ratio of geometric least square mean|0.955|||||TWO_SIDED|90.0|0.922|0.989|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.989|0.922|
91633595|NCT02442765|183160301|SUPERIORITY||Least Squares Mean Difference|3.3|||=|0.333|TWO_SIDED|95.0|-3.5|10.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||10.1|-3.5|=0.333
91633596|NCT02442765|183160301|SUPERIORITY||MMRM weighted z-statistic|-1.5|||=|0.133|TWO_SIDED||||||ANCOVA|||||||=0.133
91633597|NCT02442765|183160301|SUPERIORITY||MMRM weighted z-statistic|0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
91792527|NCT02129777|183462743|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|1.76||0.11|TWO_SIDED|95.0|-0.7|6.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.3|-0.7|0.110
91633598|NCT02442765|183160302|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.118|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|=0.118
91633599|NCT02442765|183160302|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.191|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.191
91633600|NCT02442765|183160302|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.225|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.225
91633601|NCT02442765|183160302|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.227|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.227
91633602|NCT02442765|183160302|SUPERIORITY||SPCD OLS weighted z-statistic|-1.97|||=|0.049|TWO_SIDED||||||ANCOVA|||||||=0.049
91792528|NCT02129777|183462744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.827|TWO_SIDED|95.0|-0.265|0.211|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.211|-0.265|0.827
91792529|NCT02129777|183462744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.036||||0.768|TWO_SIDED|95.0|-0.269|0.198|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.198|-0.269|0.768
91484474|NCT05896748|182842880|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.907|0.991|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.991|0.907|
91633603|NCT02442765|183160302|SUPERIORITY||SPCD OLS weighted z-statistic|-1.78|||=|0.075|TWO_SIDED||||||ANCOVA|||||||=0.075
91633604|NCT02442765|183160303|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.364|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.364
91633605|NCT02442765|183160303|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.427|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|=0.427
91633606|NCT02442765|183160303|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.098|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|=0.098
91633607|NCT02442765|183160303|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.168|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|=0.168
91633608|NCT02442765|183160303|SUPERIORITY||SPCD OLS weighted z-statistic|-1.86|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
91633609|NCT02442765|183160303|SUPERIORITY||SPCD OLS weighted z-statistic|-1.57|||=|0.115|TWO_SIDED||||||ANCOVA|||||||=0.115
91525817|NCT02567825|182927156|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes categorized as probably severe.||1.09|0.76|
91633610|NCT02442765|183160304|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.014|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|=0.014
91633611|NCT02442765|183160304|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.111|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.111
91633612|NCT02442765|183160304|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.062|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||0.0|-1.1|=0.062
91633613|NCT02442765|183160304|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.305|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|=0.305
91633614|NCT02442765|183160304|SUPERIORITY||SPCD OLS weighted z-statistic|-3.01|||=|0.003|TWO_SIDED||||||ANCOVA|||||||=0.003
91633615|NCT02442765|183160304|SUPERIORITY||SPCD OLS weighted z-statistic|-1.79|||=|0.073|TWO_SIDED||||||ANCOVA|||||||=0.073
91633616|NCT02442765|183160305|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.909|TWO_SIDED|95.0|-2.2|2.5|||ANCOVA|||||2.5|-2.2|=0.909
91633617|NCT02442765|183160305|SUPERIORITY||Least Squares Mean Difference|1.4|||=|0.226|TWO_SIDED|95.0|-0.9|3.8|||ANCOVA|||||3.8|-0.9|=0.226
91633618|NCT02442765|183160305|SUPERIORITY||Least Squares Mean Difference|2.1|||=|0.405|TWO_SIDED|95.0|-2.9|7.1|||ANCOVA|||||7.1|-2.9|=0.405
91633619|NCT02442765|183160305|SUPERIORITY||Least Squares Mean Difference|-0.9|||=|0.714|TWO_SIDED|95.0|-5.8|4.0|||ANCOVA|||||4.0|-5.8|=0.714
91633620|NCT02442765|183160305|SUPERIORITY||SPCD OLS weighted z-statistic|0.75|||=|0.456|TWO_SIDED||||||ANCOVA|||||||=0.456
91633621|NCT02442765|183160305|SUPERIORITY||SPCD OLS weighted z-statistic|0.42|||=|0.678|TWO_SIDED||||||ANCOVA|||||||=0.678
91633622|NCT02442765|183160306|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.278|TWO_SIDED|95.0|-1.1|0.3|||ANCOVA|||||0.3|-1.1|=0.278
91633623|NCT02442765|183160306|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.817|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|=0.817
91667271|NCT01559116|183228378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.096|0.184|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.184|0.096|<0.0001
91667272|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.417|0.509|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.509|0.417|<0.0001
91633624|NCT02442765|183160306|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.5|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||||0.7|-1.4|=0.500
91633625|NCT02442765|183160306|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.795|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||||1.2|-0.9|=0.795
91633626|NCT02442765|183160306|SUPERIORITY||SPCD OLS weighted z-statistic|-1.25|||=|0.213|TWO_SIDED||||||ANCOVA|||||||=0.213
91633627|NCT02442765|183160306|SUPERIORITY||SPCD OLS weighted z-statistic|0.02|||=|0.985|TWO_SIDED||||||ANCOVA|||||||=0.985
91633628|NCT02442765|183160308|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.018|TWO_SIDED|95.0|-2.9|-0.3|||ANCOVA|||||-0.3|-2.9|=0.018
91633629|NCT02442765|183160308|SUPERIORITY||Least Squares Mean Difference|0.0|||=|0.956|TWO_SIDED|95.0|-1.3|1.3|||ANCOVA|||||1.3|-1.3|=0.956
91633630|NCT02442765|183160308|SUPERIORITY||Least Squares Mean Difference|1.1|||=|0.451|TWO_SIDED|95.0|-1.8|4.0|||ANCOVA|||||4.0|-1.8|=0.451
91633631|NCT02442765|183160308|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.519|TWO_SIDED|95.0|-1.9|3.7|||ANCOVA|||||3.7|-1.9|=0.519
91633632|NCT02442765|183160308|SUPERIORITY||SPCD OLS weighted z-statistic|-0.72|||=|0.471|TWO_SIDED||||||ANCOVA|||||||=0.471
91633633|NCT02442765|183160308|SUPERIORITY||SPCD OLS weighted z-statistic|0.5|||=|0.618|TWO_SIDED||||||ANCOVA|||||||=0.618
91633634|NCT01693562|183160348|EQUIVALENCE|Other||||||0.016|||||||Regression, Cox|||||||0.016
91633635|NCT01693562|183160349|EQUIVALENCE|Other||||||0.0046|||||||Regression, Cox|||||||0.0046
91633636|NCT04607291|183160351|OTHER|A logistic regression model was used to identify factors associated with screening.|||||||||||||||||"A logistic regression model was used to identify factors associated with screening. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, stool test recommended by physician, know where to get stool test, fear of colonoscopy index score, ABR - afraid score, and knowledge that colonoscopy can reduce worry.~AUC: 0.71"|||
91633637|NCT04607291|183160352|OTHER|A logistic regression model was used to identify characteristics associated with high intent of getting a Fit test.||||||||||||||||Evaluating factors associated with high intent of getting a Fit test.|"A logistic regression model was used to identify factors associated with high intent of getting a fit test. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, race, stool test or colonoscopy recommended by physician, know where to get stool test, CBPR score, and barriers to screening score.~AUC: 0.80"|||
91633638|NCT05466240|183160353|EQUIVALENCE|For each post-baseline collection time point, treatment difference and p-value comparing the mean change in viral load from baseline between treatment arms from an analysis of covariance model with covariate baseline viral load.|||||<|0.95|||||||ANCOVA|||||||<0.95
91633639|NCT02759939|183160356|SUPERIORITY||Odds Ratio (OR)|1.23||||0.8|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.80
91633640|NCT02759939|183160356|SUPERIORITY||Odds Ratio (OR)|1.47||||0.32|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.32
91633641|NCT02759939|183160356|SUPERIORITY||Odds Ratio (OR)|0.95||||0.99|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.99
91633642|NCT02759939|183160356|SUPERIORITY||Odds Ratio (OR)|0.8||||0.72|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.72
91667273|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.154|0.246|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.246|0.154|<0.0001
91667274|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.225|0.133|<0.0001
91714410|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|11.22||0.3039||95.0|-33.6|10.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.5|-33.6|0.3039
91714411|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|10.77||0.4595||95.0|-29.2|13.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.2|-29.2|0.4595
91792530|NCT02129777|183462744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.112||||0.338|TWO_SIDED|95.0|-0.33|0.106|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.106|-0.330|0.338
91792531|NCT02129777|183462744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.017||||0.89|TWO_SIDED|95.0|-0.261|0.226|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.226|-0.261|0.890
91792532|NCT02129777|183462745|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.048||||0.295|TWO_SIDED|95.0|-0.043|0.139|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12:CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.139|-0.043|0.295
91633643|NCT04735432|183160377|NON_INFERIORITY|This was a phase 3, multicenter, randomized, open-label, parallel-group, 12-week study to evaluate the noninferiority of the pharmacodynamic effect of efgartigimod PH20 SC 1000 mg compared with efgartigimod IV 10 mg/kg in patients with generalized myasthenia gravis.|LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.782|<|0.0001|TWO_SIDED|95.0|-7.73|-0.66|||ANCOVA|||The primary endpoint was analyzed using an ANCOVA model with treatment as a factor and total IgG levels at baseline as a covariate. The NI evaluation was based on a percent reduction from baseline in total IgG levels at day 29 (week 4) using an NI margin of 10%. Only the results for mITT analysis set are entered.||-0.66|-7.73|< 0.0001
91633644|NCT00626327|183160391|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.4|0.5||||||Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.||0.5|-3.4|
91633645|NCT00626327|183160391|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for mumps was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV - MMRV )|1.0|||||TWO_SIDED|95.0|-1.0|3.7||||||Non-inferiority of immune response to mumps following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||3.7|-1|
91667275|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.443|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.396|0.49|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.490|0.396|<0.0001
91792533|NCT02129777|183462746|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.012||||0.906|TWO_SIDED|95.0|-0.191|0.216|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.216|-0.191|0.906
91792534|NCT02129777|183462746|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04||||0.677|TWO_SIDED|95.0|-0.222|0.143|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.143|-0.222|0.677
91792535|NCT02129777|183462746|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13||||0.107|TWO_SIDED|95.0|-0.268|0.007|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.007|-0.268|0.107
91633646|NCT00626327|183160391|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for rubella was greater than -5%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-2.0|||||TWO_SIDED|95.0|-4.5|0.8||||||Non-inferiority of immune response to rubella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||0.8|-4.5|
91792536|NCT02129777|183462746|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.371|TWO_SIDED|95.0|-0.248|0.087|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.087|-0.248|0.371
91484475|NCT05896748|182842880|OTHER||Ratio of geometric least square mean|1.014|||||TWO_SIDED|90.0|0.972|1.058|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within RPV||1.058|0.972|
91633647|NCT00626327|183160391|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroprotection for varicella was greater than -10%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.9|1.2||||||Non-inferiority of immune response to varicella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||1.2|-3.9|
91633648|NCT00626327|183160392|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-4.7|4.5||||||Non-inferiority of immune response of MenACWY-CRM against serogroup A when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||4.5|-4.7|
91633649|NCT00626327|183160392|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup C when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||1.9|-1.8|
91633650|NCT00626327|183160392|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|1.0|||||TWO_SIDED|95.0|-1.3|3.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup W-135 when concomitantly administered with MMRV vaccine as compared to MenACWY vaccine given alone.||3.9|-1.3|
91633651|NCT00626327|183160392|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|2.0|||||TWO_SIDED|95.0|-1.9|5.3||||||Non-inferiority of immune response of MenACWY-CRM against serogroup Y when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||5.3|-1.9|
91667276|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.134|0.227|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.227|0.134|<0.0001
91667277|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.125|0.218|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.218|0.125|<0.0001
91667278|NCT01559116|183228379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.113|0.206|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.206|0.113|<0.0001
91667279|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.355|0.453|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.453|0.355|<0.0001
91667280|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.17|0.267|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.267|0.170|<0.0001
91667281|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.126|0.223|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.223|0.126|<0.0001
91792537|NCT02129777|183462747|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.095||||0.134|TWO_SIDED|95.0|-0.03|0.221|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.221|-0.030|0.134
91484476|NCT06138145|182842925|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91484477|NCT06138145|182842925|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mann-Whitney U test|||||||<0.05
91484478|NCT06138145|182842925|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91633652|NCT00626327|183160397|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MMRV+MenACWY group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentages of subjects with seroconversion for varicella was greater than -10%.|Difference% (MenACWY-CRM+MMRV- MMRV)|-1.0|||||TWO_SIDED|95.0|-2.4|0.8||||||Non-inferiority of anti-varicella response following one dose of MMRV when administered concomitantly with MenACWY vaccine as compared to MMRV administered alone.||0.8|-2.4|
91792538|NCT02129777|183462748|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.258|TWO_SIDED|95.0|-0.6|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.||0.2|-0.6|0.258
91792539|NCT02129777|183462748|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.365|TWO_SIDED|95.0|-0.5|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.2|-0.5|0.365
91667282|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.301|0.4|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.400|0.301|<0.0001
91667283|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.117|0.214|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.214|0.117|<0.0001
91667284|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.099|0.197|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.197|0.099|<0.0001
91633653|NCT03347279|183160406|SUPERIORITY||Rate Ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.37|0.53|||Negative Binomial|||||0.53|0.37|<0.001
91633654|NCT03347279|183160407|SUPERIORITY||Rate Ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.46|0.75|||Negative Binomial|||||0.75|0.46|<0.001
91633655|NCT03347279|183160408|SUPERIORITY||Least Squares (LS) Mean Difference|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||||0.18|0.08|<0.001
91633656|NCT03347279|183160409|SUPERIORITY||LS Means Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.2|0.47|||Mixed Models Analysis|||||0.47|0.2|<0.001
91667285|NCT01559116|183228380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.170|0.072|<0.0001
91667286|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.274|0.385|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.385|0.274|<0.0001
91667287|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.115|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.225|0.115|<0.0001
91792540|NCT02129777|183462748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.757|TWO_SIDED|95.0|-0.3|0.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.4|-0.3|0.757
91633657|NCT03347279|183160410|SUPERIORITY||LS Means Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.2|-0.46|<0.001
91633658|NCT03347279|183160411|SUPERIORITY||LS Means Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||||-0.04|-0.19|0.004
91633659|NCT04880642|183160446|SUPERIORITY|"The null hypothesis was that the there was no difference in survival up to Day 60 between the two groups and was to be rejected in favour of the alternative hypothesis i.e. a difference in survival up to Day 60 between the two groups excisted.~The overall 2-sided significance level of 5% was applied to the primary endpoint."|Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.4|2.36|||Log Rank|||||2.36|0.40|0.949
91633660|NCT04880642|183160447|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.301|TWO_SIDED|95.0|0.91|1.52|||Log Rank|||||1.52|0.91|0.301
91633661|NCT04880642|183160448|SUPERIORITY||Median Difference (Final Values)|0.0||||0.425|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.425
91633662|NCT04880642|183160449|SUPERIORITY||Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.91||0.671|TWO_SIDED|95.0|-9.3|6.0|||Regression, Logistic|||||6.0|-9.3|0.671
91633663|NCT04880642|183160450|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|5.62||0.948|TWO_SIDED|95.0|-11.4|10.6|||Regression, Logistic|||||10.6|-11.4|0.948
91633664|NCT02987205|183160507|NON_INFERIORITY|If the upper bound of this 95% CI was less than the prespecified non-inferiority limit of 0.50, the Test product would be claimed to be non-inferior to the Comparator product.||||||0.013||||||Wilcoxon matched-pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.0130
91633665|NCT05306964|183160540|OTHER|||||||0.5|||||||GLMM|||||||0.5
91633666|NCT05306964|183160541|OTHER|||||||0.4|||||||GLMM|||||||0.4
91633667|NCT05306964|183160542|OTHER|||||||0.5|||||||GLMM|||||||0.5
91633668|NCT05306964|183160543|OTHER|||||||0.3|||||||GLMM|||||||0.3
91633669|NCT05306964|183160544|OTHER|||||||0.4|||||||GLMM|||||||0.4
91633670|NCT05306964|183160545|OTHER|||||||0.5|||||||GLMM|||||||0.5
91633671|NCT05306964|183160546|OTHER|||||||0.3|||||||GLMM|||||||0.3
91633672|NCT05306964|183160547|OTHER|||||||0.3|||||||GLMM|||||||0.3
91633673|NCT05306964|183160548|OTHER|||||||0.7|||||||GLMM|||||||0.7
91633674|NCT05306964|183160549|OTHER|||||||0.2|||||||GLMM|||||||0.2
91633675|NCT05306964|183160550|OTHER|||||||0.02|||||||GLMM|||||||0.02
91633676|NCT05306964|183160551|OTHER|||||||0.2|||||||GLMM|||||||0.2
91633677|NCT05306964|183160552|OTHER|||||||0.7|||||||GLMM|||||||0.7
91633678|NCT05306964|183160553|OTHER|||||||0.1|||||||GLMM|||||||0.1
91633679|NCT05306964|183160554|OTHER|||||||0.2|||||||GLMM|||||||0.2
91633680|NCT05306964|183160555|OTHER||||||<|0.001|||||||GLMM|||||||<0.001
91633681|NCT05306964|183160556|OTHER|||||||0|||||||GLMM|||||||0
91633682|NCT05306964|183160557|OTHER|||||||0.5|||||||GLMM|||||||0.5
91633683|NCT05306964|183160558|OTHER|||||||0.9|||||||GLMM|||||||0.9
91633684|NCT05306964|183160559|OTHER|||||||0.8|||||||GLMM|||||||0.8
91633685|NCT05306964|183160560|OTHER|||||||0|||||||GLMM|||||||0
91633686|NCT05306964|183160561|OTHER|||||||0|||||||GLMM|||||||0
91633687|NCT05306964|183160562|OTHER|||||||0.2|||||||GLMM|||||||0.2
91633688|NCT05306964|183160563|OTHER|||||||0|||||||GLMM|||||||0
91633689|NCT05306964|183160564|OTHER|||||||0.9|||||||GLMM|||||||0.9
91633690|NCT05306964|183160565|OTHER|||||||0|||||||GLMM|||||||0
91633691|NCT05306964|183160566|OTHER|||||||0.9|||||||GLMM|||||||0.9
91633692|NCT05306964|183160567|OTHER|||||||0|||||||GLMM|||||||0
91633693|NCT05306964|183160568|OTHER|||||||0|||||||GLMM|||||||0
91633694|NCT05306964|183160569|OTHER|||||||0|||||||GLMM|||||||0
91633695|NCT05306964|183160570|OTHER|||||||0.5|||||||GLMM|||||||0.5
91633696|NCT05306964|183160571|OTHER|||||||0.2|||||||GLMM|||||||0.2
91633697|NCT05306964|183160572|OTHER|||||||0.3|||||||GLMM|||||||0.3
91633698|NCT00750867|183160609|SUPERIORITY_OR_OTHER|||||||0.0128||||||The P-Value was obtained by comparing the UMSARS-I scores at final visit and at baseline.|ANOVA|||||||0.0128
91633699|NCT00750867|183160609|SUPERIORITY_OR_OTHER|||||||0.025||||||The P-Value was obtained by comparing the UMSARS-II scores at final visit and at baseline.|ANOVA|||||||0.025
91633700|NCT03018340|183160610|SUPERIORITY||Difference in weighted MMRM LSMs|-1.7|STANDARD_ERROR_OF_MEAN|0.85||0.039|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||This is the primary statistical comparison for Stage 1 and Stage 2 combined.||-0.1|-3.4|0.0390
91633701|NCT03018340|183160610|SUPERIORITY||Difference in MMRM LSMs|-4.0|STANDARD_ERROR_OF_MEAN|1.09||0.0003|TWO_SIDED|95.0|-6.1|-1.9|||Mixed Models Analysis|||||-1.9|-6.1|0.0003
91633702|NCT03018340|183160610|SUPERIORITY||Difference in MMRM LSMs|0.5|STANDARD_ERROR_OF_MEAN|1.3||0.694|TWO_SIDED|95.0|-2.1|3.1|||Mixed Models Analysis|||||3.1|-2.1|0.6940
91633703|NCT04652102|183160621|SUPERIORITY||Proportion|0.364|||||TWO_SIDED|95.826|0.299|0.433|||||Derived from an exact 2-sided 95.826% Pearson-Clopper confidence interval (CI) on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.433|0.299|
91633704|NCT04652102|183160621|OTHER||Vaccine Efficacy|48.2||||0.016|TWO_SIDED|95.826|31.0|61.4||1-sided p-value from the exact binomial test on proportion of cases coming from the CVnCoV group among all cases (equivalent to a test on VE with H0: VE ≤30%). Statistically significant if lower than 0.02087.|Exact Binomial Test||2-sided 95.826% CI on VE, derived from the exact 2-sided 95.826% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Vaccine efficacy (VE) calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||61.4|31.0|0.01600
91633705|NCT04652102|183160633|SUPERIORITY||Proportion|0.245|||||TWO_SIDED|95.0|0.133|0.389|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.389|0.133|
91633706|NCT04652102|183160633|SUPERIORITY||Vaccine Efficacy|70.7|||||TWO_SIDED|95.0|42.5|86.1|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||86.1|42.5|
91633707|NCT04652102|183160634|SUPERIORITY||Proportion|0.286|||||TWO_SIDED|95.0|0.084|0.581|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.581|0.084|
91633708|NCT04652102|183160634|SUPERIORITY||Vaccine Efficacy|63.8|||||TWO_SIDED|95.0|-25.5|91.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||91.7|-25.5|
91633709|NCT04652102|183160635|SUPERIORITY||Proportion|0.341|||||TWO_SIDED|95.0|0.242|0.452|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.452|0.242|
91633710|NCT04652102|183160635|SUPERIORITY||Vaccine Efficacy|53.2|||||TWO_SIDED|95.0|25.4|71.2|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||71.2|25.4|
91633711|NCT04652102|183160636|SUPERIORITY||Proportion|0.571|||||TWO_SIDED|95.0|0.34|0.782|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.782|0.340|
91667288|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.066|0.176|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.176|0.066|<0.0001
91792541|NCT02129777|183462748|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.825|TWO_SIDED|95.0|-0.4|0.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.3|-0.4|0.825
91633712|NCT04652102|183160636|SUPERIORITY||Vaccine Efficacy|-11.8|||||TWO_SIDED|95.0|-200.5|56.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||56.7|-200.5|
91633713|NCT01756833|183160673|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.035||0.71|TWO_SIDED|95.0|-0.07|0.07||Two prespecified interim analyses for efficacy performed when 1/3 \& 2/3 of primary outcome available, significance level, 1-sided, alpha=.0005. Final analysis 1-sided, alpha=.024. Futility analysis performed when \~2/3 primary outcome was available.|ANCOVA on normal scores|||"Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.~Sample size: The criterion (alpha) set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level."|For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline).|0.07|-0.07|0.71
91633714|NCT00808132|183160682|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.822|2.201|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.201|0.822|<0.001
91633715|NCT00808132|183160682|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|||<|0.001|TWO_SIDED|95.0|1.209|2.533|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.533|1.209|<0.001
91633716|NCT00808132|183160683|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.017|TWO_SIDED|95.0|0.139|1.47|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.470|0.139|0.017
91633717|NCT00808132|183160683|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|||<|0.001|TWO_SIDED|95.0|0.556|1.83|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.830|0.556|<0.001
91633718|NCT00808132|183160684|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.901|1.742|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.742|0.901|<0.001
91633719|NCT00808132|183160684|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|||<|0.001|TWO_SIDED|95.0|0.756|1.671|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.671|0.756|<0.001
91633720|NCT00808132|183160684|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.152|1.962|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.962|1.152|<0.001
91633721|NCT00808132|183160684|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.164|2.044|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.044|1.164|<0.001
91633722|NCT00808132|183160685|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Fisher Exact|||||||0.138
91633723|NCT00808132|183160685|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91633724|NCT00808132|183160685|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Fisher Exact|||||||0.765
91633725|NCT00808132|183160685|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91633726|NCT00808132|183160685|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91633727|NCT00808132|183160686|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.832|TWO_SIDED|95.0|-0.632|0.509|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.509|-0.632|0.832
91633728|NCT00808132|183160686|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.651|TWO_SIDED|95.0|-0.696|0.436|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.436|-0.696|0.651
91633729|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633730|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0074|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0074
91633731|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633732|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633733|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633734|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91667289|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.251|0.363|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.363|0.251|<0.0001
91667290|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.092|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.092|<0.0001
91667291|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.111|0.222|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.222|0.111|<0.0001
91667292|NCT01559116|183228381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.043|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.043|<0.0001
91667293|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.408|0.516|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.516|0.408|<0.0001
91667294|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.105|0.212|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.212|0.105|<0.0001
91667295|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.098|0.205|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.205|0.098|<0.0001
91667296|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.452|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.398|0.507|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.507|0.398|<0.0001
91667297|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.095|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.095|<0.0001
91667298|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.216|0.107|<0.0001
91667299|NCT01559116|183228382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.087|0.196|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.196|0.087|<0.0001
91633735|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633736|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633737|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633738|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
91633739|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633740|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633741|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633742|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.1058|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.1058
91667300|NCT04610580|183228385|OTHER||Geometric Least Square Mean Ratio (%)|95.0|||||TWO_SIDED|90.0|82.1|110.0||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using analysis of variance (ANOVA) statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.0|82.1|
91633743|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633744|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0024
91633745|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633746|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633747|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633748|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633749|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633750|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0012
91633751|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633752|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633753|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633754|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0029
91633755|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633756|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0046
91633757|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633758|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0043|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0043
91633759|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633760|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633761|NCT00808132|183160687|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
91633762|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633763|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91667301|NCT04610580|183228386|OTHER||Geometric Least Square Mean Ratio (%)|96.243|||||TWO_SIDED|90.0|86.384|107.227||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||107.227|86.384|
91633764|NCT00808132|183160687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
91633765|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.546
91633766|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.821
91633767|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.698
91633768|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.446
91633769|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
91633770|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.810
91633771|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.473
91633772|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.030
91633773|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.453
91633774|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.391
91633775|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.407
91667302|NCT04610580|183228387|OTHER||Geometric Least Square Mean Ratio (%)|94.9|||||TWO_SIDED|90.0|81.6|110.5||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.5|81.6|
91667303|NCT04610580|183228388|OTHER||Geometric Least Square Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|70.6|145.1||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||145.1|70.6|
91667304|NCT04610580|183228389|OTHER||Geometric Least Square Mean Ratio (%)|99.1|||||TWO_SIDED|90.0|89.3|109.9||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||109.9|89.3|
91667305|NCT01942135|183228455|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.422|||<|1e-06|TWO_SIDED|95.0|0.318|0.56||The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance was 0.00135.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||0.560|0.318|<0.000001
91667306|NCT01942135|183228457|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.814|||=|0.0429|TWO_SIDED|95.0|0.644|1.029||1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomization.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib plus fulvestrant.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||1.029|0.644|=0.0429
91667307|NCT01942135|183228459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.783||||0.0001|TWO_SIDED|95.0|1.563|5.603||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An Odds Ratio \>1 means better response in favor of the palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||5.603|1.563|0.0001
91667308|NCT01942135|183228461|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.016|||<|0.0001|TWO_SIDED|95.0|2.046|4.565||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An odds ratio \> 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||4.565|2.046|<0.0001
91667309|NCT01942135|183228465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.0313|TWO_SIDED|95.0|0.3|6.0||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL||6.0|0.3|0.0313
91667310|NCT01942135|183228465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.4|TWO_SIDED|95.0|-1.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning||3.5|-1.4|0.4000
91667311|NCT01942135|183228465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.2615|TWO_SIDED|95.0|-1.5|5.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning||5.3|-1.5|0.2615
91667312|NCT01942135|183228465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.0016|TWO_SIDED|95.0|1.7|7.4||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning||7.4|1.7|0.0016
91667313|NCT01942135|183228465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.365|TWO_SIDED|95.0|-1.4|3.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning||3.8|-1.4|0.3650
91633776|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.644
91633777|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.666
91633778|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.641
91633779|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.361
91633780|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.100
91633781|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.142
91633782|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.906
91633783|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.798
91633784|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.258|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.258
91633785|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.058
91633786|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.230
91633787|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.360
91633788|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
91633789|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.912
91633790|NCT00808132|183160689|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.791
91633791|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93||||0.253|TWO_SIDED|95.0|-7.96|2.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.10|-7.96|0.253
91633792|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84||||0.127|TWO_SIDED|95.0|-8.78|1.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.10|-8.78|0.127
91633793|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.15||||0.18|TWO_SIDED|95.0|-7.76|1.46|||ANCOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.46|-7.76|0.180
91633794|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.67||||0.247|TWO_SIDED|95.0|-7.19|1.85|||ANOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.85|-7.19|0.247
91633795|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63||||0.726|TWO_SIDED|95.0|-4.15|2.9|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.90|-4.15|0.726
91633796|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.17||||0.218|TWO_SIDED|95.0|-5.63|1.29|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.29|-5.63|0.218
91633797|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.996|TWO_SIDED|95.0|-3.85|3.87|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||3.87|-3.85|0.996
91633798|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean DIfference|0.83||||0.665|TWO_SIDED|95.0|-2.94|4.6|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||4.60|-2.94|0.665
91667314|NCT01942135|183228465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9615|TWO_SIDED|95.0|-3.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning||3.5|-3.4|0.9615
91667315|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.32|TWO_SIDED|95.0|-4.5|1.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue||1.5|-4.5|0.3200
91667316|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0369|TWO_SIDED|95.0|-4.8|-0.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting||-0.2|-4.8|0.0369
91792542|NCT02129777|183462749|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.163||0.931|TWO_SIDED|95.0|-4.48|4.1|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.10|-4.48|0.931
91484479|NCT00857415|182842933|SUPERIORITY_OR_OTHER||Correlation coefficient|0.78|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.58|0.89||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Correlation test||Asymptotic standard error and 95 percent CI used Fisher z-transformation.|Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.89|0.58|<0.0001
91484480|NCT00857415|182842934|SUPERIORITY_OR_OTHER||Specificity|100.0|||||TWO_SIDED|95.0|91.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 3 blinded readers||100|91|
91667317|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3||||0.0011|TWO_SIDED|95.0|-8.5|-2.1||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain||-2.1|-8.5|0.0011
91667318|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7699|TWO_SIDED|95.0|-3.7|2.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea||2.8|-3.7|0.7699
91667319|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.2721|TWO_SIDED|95.0|-5.5|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia||1.6|-5.5|0.2721
91667320|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.7334|TWO_SIDED|95.0|-4.1|2.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss||2.9|-4.1|0.7334
91667321|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.6491|TWO_SIDED|95.0|-2.5|3.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation||3.9|-2.5|0.6491
91667322|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.6293|TWO_SIDED|95.0|-2.8|1.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea||1.7|-2.8|0.6293
91667323|NCT01942135|183228466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.8812|TWO_SIDED|95.0|-3.1|3.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties||3.6|-3.1|0.8812
91667324|NCT01942135|183228467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.1386|TWO_SIDED|95.0|-0.7|5.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for body image||5.2|-0.7|0.1386
91667325|NCT01942135|183228467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.5235|TWO_SIDED|95.0|-3.1|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual functioning||1.6|-3.1|0.5235
91484481|NCT03614975|182842977|OTHER|||||||0.28||||||A/H1N1|Chi-squared|||||||0.28
91484482|NCT03614975|182842977|OTHER|||||||0.64||||||A/H3N2|Chi-squared|||||||0.64
91484483|NCT03614975|182842977|OTHER|||||||0.64||||||B/Colorado|Chi-squared|||||||0.64
91484484|NCT03614975|182842977|OTHER|||||||0.23||||||B/Phuket|Chi-squared|||||||0.23
91484485|NCT03614975|182842978|OTHER|||||||0.42||||||Vaccine Strain: A/H1N1:Day 0|Chi-squared|||||||0.42
91484486|NCT03614975|182842978|OTHER|||||||0.16||||||Vaccine Strain: A/H1N1: Day 21|Chi-squared|||||||0.16
91484487|NCT03614975|182842978|OTHER|||||||0.42||||||Vaccine Strain: A/H3N2: Day 0|Chi-squared|||||||0.42
91633799|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|2.76||||0.368|TWO_SIDED|95.0|-3.26|8.78|||ANOVA|||Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.78|-3.26|0.368
91484488|NCT03614975|182842978|OTHER|||||||0.94||||||Vaccine Strain: A/H3N2: Day 21|Chi-squared|||||||0.94
91484489|NCT03614975|182842978|OTHER|||||||0.87||||||Vaccine Strain: B/Colorado :Day 0|Chi-squared|||||||0.87
91484490|NCT03614975|182842978|OTHER|||||||0.77||||||Vaccine Strain: B/Colorado : Day 21|Chi-squared|||||||0.77
91484491|NCT03614975|182842978|OTHER|||||||0.33||||||Vaccine Strain: B/Phuket: Day 0|Chi-squared|||||||0.33
91484492|NCT03614975|182842978|OTHER|||||||0.21||||||Vaccine Strain: B/Phuket: Day 21|Chi-squared|||||||0.21
91484493|NCT03614975|182842979|OTHER|||||||0.49||||||Vaccine Strain: A/H1N1: Day 0|Kruskal-Wallis|||||||0.49
91484494|NCT03614975|182842979|OTHER|||||||0.23||||||Vaccine Strain: A/H1N1: Day 21|Kruskal-Wallis|||||||0.23
91633800|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|2.84||||0.345|TWO_SIDED|95.0|-3.07|8.75|||ANCOVA|||Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.75|-3.07|0.345
91633801|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.35||||0.482|TWO_SIDED|95.0|-5.12|2.42|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.42|-5.12|0.482
91633802|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean DIfference|-2.15||||0.254|TWO_SIDED|95.0|-5.86|1.55|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.55|-5.86|0.254
91633803|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97||||0.308|TWO_SIDED|95.0|-5.76|1.82|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.82|-5.76|0.308
91633804|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48||||0.19|TWO_SIDED|95.0|-6.2|1.23|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.23|-6.20|0.190
91633805|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.55|TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.17|-0.32|0.550
91633806|NCT00808132|183160690|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.477|TWO_SIDED|95.0|-0.15|0.32|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.32|-0.15|0.477
91633807|NCT00808132|183160692|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
91633808|NCT00808132|183160692|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
91633809|NCT00808132|183160692|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.680
91484495|NCT03614975|182842979|OTHER|||||||0.1||||||Vaccine Strain: A/H3N2: Day 0|Kruskal-Wallis|||||||0.10
91484496|NCT03614975|182842979|OTHER|||||||0.86||||||Vaccine Strain: A/H3N2: Day 21|Kruskal-Wallis|||||||0.86
91484497|NCT03614975|182842979|OTHER|||||||0.73||||||Vaccine Strain: B/Colorado: Day 0|Kruskal-Wallis|||||||0.73
91633810|NCT00808132|183160692|SUPERIORITY_OR_OTHER|||||||0.493|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.493
91633811|NCT00808132|183160692|SUPERIORITY_OR_OTHER|||||||0.698|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.698
91633812|NCT00808132|183160692|SUPERIORITY_OR_OTHER|||||||0.055|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.055
91484498|NCT03614975|182842979|OTHER|||||||0.67||||||Vaccine Strain: B/Colorado: Day 21|Kruskal-Wallis|||||||0.67
91484499|NCT03614975|182842979|OTHER|||||||0.36||||||Vaccine Strain: B/Phuket: Day 0|Kruskal-Wallis|||||||0.36
91484500|NCT03614975|182842979|OTHER|||||||0.65||||||Vaccine Strain: B/Phuket: Day 21|Kruskal-Wallis|||||||0.65
91484501|NCT01390220|182842980|SUPERIORITY|||||||0.0109|||||||Fisher Exact|2-sided||||||0.0109
91484502|NCT01390220|182842981|SUPERIORITY|||||||0.0043|||||||Fisher Exact|2-sided||||||0.0043
91484503|NCT01390220|182842982|SUPERIORITY|||||||0.0124|||||||Log Rank|||||||0.0124
91484504|NCT01390220|182842983|SUPERIORITY|||||||0.0124|||||||Log Rank|||Kaplan-Meier estimates.||||0.0124
91484505|NCT00943124|182842984|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.14||||||90.0|1.09|1.2||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.20|1.09|
91484506|NCT00943124|182842985|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.11||||||90.0|1.05|1.16||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.16|1.05|
91633813|NCT00808132|183160692|SUPERIORITY_OR_OTHER|||||||0.428|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.428
91633814|NCT00808132|183160692|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.071
91633815|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.624
91633816|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.868
91633817|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.087
91633818|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.425
91633819|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.307|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.307
91633820|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.689
91633821|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.285
91633822|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
91633823|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.065
91633824|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.014
91633825|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||1.000
91633826|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.226
91633827|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||1.000
91633828|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633829|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633830|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
91667326|NCT01942135|183228467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.6271|TWO_SIDED|95.0|-4.4|7.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual enjoyment||7.3|-4.4|0.6271
91633831|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633832|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633833|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
91667327|NCT01942135|183228467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.0845|TWO_SIDED|95.0|-0.5|7.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for future perspective||7.6|-0.5|0.0845
91633834|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633835|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633836|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633837|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633838|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633839|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633840|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633841|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.317
91633842|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.531
91633843|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.610
91633844|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.848
91633845|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.551|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.551
91633846|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.300
91633847|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.299
91633848|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
91633849|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.660
91633850|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.199
91633851|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.770
91484507|NCT00943124|182842986|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.97||||||90.0|0.93|1.0||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.00|0.93|
91484508|NCT00943124|182842987|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.87|0.97||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.97|0.87|
91484509|NCT00943124|182842988|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.02||||||90.0|0.99|1.04||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.04|0.99|
91484510|NCT00943124|182842989|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.08||||||90.0|1.02|1.14||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.14|1.02|
91633852|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||1.000
91633853|NCT00808132|183160693|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.769
91633854|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633855|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633856|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633857|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633858|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633859|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633860|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633861|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633862|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633863|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633864|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633865|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633866|NCT00808132|183160693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
91633867|NCT01846208|183160721|SUPERIORITY||Risk Difference (RD)|32.4||||0.009|TWO_SIDED|95.0|8.9|55.8|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized||55.8|8.9|0.009
91633868|NCT01846208|183160721|SUPERIORITY||Risk Difference (RD)|25.5||||0.031|TWO_SIDED|95.0|2.0|49.1|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||49.1|2.0|0.031
91633869|NCT01846208|183160722|SUPERIORITY||Risk Difference (RD)|64.7|||<|0.0001|TWO_SIDED|95.0|43.9|85.6|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized||85.6|43.9|<0.0001
91633870|NCT01846208|183160722|SUPERIORITY||Risk Difference (RD)|17.7||||0.151|TWO_SIDED|95.0|-2.3|37.7|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||37.7|-2.3|0.151
91633871|NCT01846208|183160722|SUPERIORITY||Risk Difference (RD)|44.3||||0.002|TWO_SIDED|95.0|19.4|69.2|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized||69.2|19.4|0.002
91633872|NCT01846208|183160722|SUPERIORITY||Risk Difference (RD)|17.5||||0.181|TWO_SIDED|95.0|-6.3|41.3|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||41.3|-6.3|0.181
91633873|NCT01846208|183160724|SUPERIORITY||Risk Difference (RD)|-50.2||||0.003|TWO_SIDED|95.0|-78.4|-21.9|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized||-21.9|-78.4|0.003
91633874|NCT01846208|183160724|SUPERIORITY||Risk Difference (RD)|33.7||||0.023|TWO_SIDED|95.0|7.2|60.1|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned||60.1|7.2|0.023
91633875|NCT00369928|183160731|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.88||||0.982|TWO_SIDED|80.0|0.56|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.56|0.982
91633876|NCT00369928|183160731|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.79||||0.666|TWO_SIDED|80.0|0.5|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.50|0.666
91633877|NCT00281528|183160740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4476||95.0||||Group comparison was performed between group 260 mg/m\^2 ABI-007 every 3 weeks and group 130 mg/m\^2 ABI-007 weekly, as based on amended protocol, no type I error adjustment for multiplicity; a priori threshold for statistical significance is 0.05.|Cochran-Mantel-Haenszel|Stratified by study site||||||0.4476
91633878|NCT02871570|183160758|OTHER||ratio|0.7789|||||TWO_SIDED|90.0|0.6514|0.9313|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9313|0.6514|
91633879|NCT02871570|183160759|OTHER||ratio|0.7776|||||TWO_SIDED|90.0|0.6493|0.9311|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9311|0.6493|
91633880|NCT02871570|183160760|OTHER||ratio|1.2844|||||TWO_SIDED|90.0|1.0732|1.5372|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.5372|1.0732|
91633881|NCT02871570|183160761|OTHER||ratio|0.7945|||||TWO_SIDED|90.0|0.5955|1.0599|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.0599|0.5955|
91633882|NCT01225211|183160774|SUPERIORITY_OR_OTHER||LS Mean difference|-2.679||||0.267|TWO_SIDED|95.0|-7.484|2.125|||ANCOVA|||||2.125|-7.484|0.267
91633883|NCT01225211|183160774|SUPERIORITY_OR_OTHER||LS Mean difference|-9.676|||<|0.001|TWO_SIDED|95.0|-14.801|-4.551|||ANCOVA|||||-4.551|-14.801|<0.001
91633884|NCT01225211|183160775|SUPERIORITY_OR_OTHER||LS Mean difference|-1.306||||0.68|TWO_SIDED|95.0|-7.565|4.953|||ANCOVA|||||4.953|-7.565|0.680
91633885|NCT01225211|183160775|SUPERIORITY_OR_OTHER||LS Mean difference|-2.67||||0.409|TWO_SIDED|95.0|-9.053|3.712|||ANCOVA|||||3.712|-9.053|0.409
91633886|NCT01225211|183160775|SUPERIORITY_OR_OTHER||LS Mean difference|-4.526||||0.161|TWO_SIDED|95.0|-10.888|1.835|||ANCOVA|||||1.835|-10.888|0.161
91633887|NCT01225211|183160775|SUPERIORITY_OR_OTHER||LS Mean difference|-2.867||||0.396|TWO_SIDED|95.0|-9.543|3.81|||ANCOVA|||||3.810|-9.543|0.396
91633888|NCT01225211|183160775|SUPERIORITY_OR_OTHER||LS Mean difference|-3.78||||0.365|TWO_SIDED|95.0|-12.028|4.467|||ANCOVA|||||4.467|-12.028|0.365
91633889|NCT01225211|183160776|SUPERIORITY_OR_OTHER||LS Mean difference|0.6||||0.5978|TWO_SIDED|95.0|-1.66|2.86|||Mixed Model Repeated Measure (MMRM)|||||2.86|-1.66|0.5978
91633890|NCT00410514|183160795|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.4|||||TWO_SIDED|95.0|-0.63|1.42|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.42|-0.63|
91633891|NCT00410514|183160795|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.62|||||TWO_SIDED|95.0|-0.43|1.68|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.68|-0.43|
91633892|NCT00410514|183160797|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-5.94|||||TWO_SIDED|95.0|-13.98|2.09|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||2.09|-13.98|
91633893|NCT00410514|183160797|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-1.39|||||TWO_SIDED|95.0|-9.73|6.96|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||6.96|-9.73|
91667328|NCT01942135|183228468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.7273|TWO_SIDED|95.0|-1.6|2.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects||2.3|-1.6|0.7273
91633894|NCT02449915|183160815|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
91633895|NCT01436357|183160816|SUPERIORITY||Hazard Ratio (HR)|1.529||||0.317|TWO_SIDED|95.0|0.661|3.535|||Regression, Cox|||||3.535|0.661|0.317
91633896|NCT01436357|183160817|SUPERIORITY||Risk Difference (RD)|0.08||||0.029|TWO_SIDED|95.0|-0.01|0.16|||Fisher Exact|||||0.16|-0.01|0.029
91633897|NCT01436357|183160818|SUPERIORITY||Risk Difference (RD)|0.1||||0.015|TWO_SIDED|95.0|0.01|0.2|||Fisher Exact|||||0.20|0.01|0.015
91667329|NCT01942135|183228468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.2671|TWO_SIDED|95.0|-2.6|0.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms||0.7|-2.6|0.2671
91667330|NCT01942135|183228468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.875|TWO_SIDED|95.0|-2.6|2.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms||2.2|-2.6|0.8750
91667331|NCT01942135|183228468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.0255|TWO_SIDED|95.0|1.1|16.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss||16.6|1.1|0.0255
91667332|NCT01942135|183228469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.037||||0.0308|TWO_SIDED|95.0|0.0|0.07||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.07|0.00|0.0308
91484511|NCT00943124|182842990|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.77||||||90.0|0.72|0.82||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.82|0.72|
91667333|NCT01942135|183228470|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.5523|TWO_SIDED|95.0|-1.9|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.5|-1.9|0.5523
91667334|NCT01942135|183228471|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.642|||<|0.001|TWO_SIDED|95.0|0.487|0.846||The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.|Unstratified log-rank test (1-sided)|1-sided p-value from the unstratified log-rank test.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.||0.846|0.487|<0.001
91667335|NCT06588530|183228478|OTHER|Log₂ transformed fold change in IgG concentration from baseline to Day 30 was compared between High and Low PFNA exposure groups using the Wilcoxon rank-sum test. A two-tailed significance level of 0.05 was used.|Mean Difference (Net)|0.15||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Tetanus||||.85
91633898|NCT01436357|183160819|SUPERIORITY||Risk Difference (RD)|0.0||||0|TWO_SIDED||||||Fisher Exact|||||||0.00
91633899|NCT01436357|183160821|SUPERIORITY||Risk Difference (RD)|0.01||||0.499|TWO_SIDED|95.0|-0.08|0.1|||Fisher Exact|||||0.10|-0.08|0.499
91633900|NCT01021293|183160841|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
91667336|NCT06588530|183228478|OTHER|Log₂ transformed fold change in IgG concentration from baseline to Day 30 was compared between High and Low PFNA exposure groups using the Wilcoxon rank-sum test. A two-tailed significance level of 0.05 was used.|Mean Difference (Net)|0.01||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Diphtheria||||.85
91667337|NCT04569084|183228500|SUPERIORITY|||||||0.777|||||||ANCOVA|||||||0.777
91667338|NCT04569084|183228501|SUPERIORITY|||||||0.169|||||||Mixed Model for Repeated Measures (MMRM)|||||||0.169
91667339|NCT04729101|183228572|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|38.98|||||TWO_SIDED|95.0|31.94|46.02||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||46.02|31.94|
91633901|NCT01021293|183160841|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
91484512|NCT00943124|182842991|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.89|0.94||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.94|0.89|
91484513|NCT02992132|182842993|SUPERIORITY||Difference in LSM|5.1|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-4.8|15.0||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||15.0|-4.8|
91667340|NCT04729101|183228572|OTHER|Additional statistics were descriptive in nature|Least-squares mean difference|44.62|||||TWO_SIDED|95.0|37.55|51.69||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||51.69|37.55|
91667341|NCT04729101|183228573|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|1.72|||||TWO_SIDED|95.0|1.4|2.04||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||2.04|1.40|
91667342|NCT04729101|183228573|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|2.09|||||TWO_SIDED|95.0|1.74|2.44||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||2.44|1.74|
91667343|NCT00762411|183228581|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Mixed Models Analysis|||||||0.560
91667344|NCT00762411|183228582|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Mixed Models Analysis|||||||0.959
91667345|NCT00762411|183228583|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Models Analysis|||||||0.567
91667346|NCT00762411|183228584|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Mixed Models Analysis|||||||0.199
91667347|NCT00762411|183228585|SUPERIORITY_OR_OTHER|||||||0.294||95.0|||||Mixed Models Analysis|||||||0.294
91667348|NCT00762411|183228586|SUPERIORITY_OR_OTHER|||||||0.477||95.0|||||Mixed Models Analysis|||||||0.477
91667349|NCT00762411|183228587|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||ANCOVA|||||||0.673
91667350|NCT00762411|183228588|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Mixed Models Analysis|||||||0.622
91667351|NCT00762411|183228589|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Mixed Models Analysis|||||||0.178
91667352|NCT00762411|183228590|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||Mixed Models Analysis|||||||0.632
91667353|NCT00762411|183228591|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||||||0.009
91667354|NCT00762411|183228592|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||ANCOVA|||||||0.426
91667355|NCT00762411|183228593|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||This is the p-value for the Right Hippocampal Volume.|ANCOVA|||||||0.101
91667356|NCT00762411|183228593|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||This is the p-value for the Left Hippocampal Volume.|ANCOVA|||||||0.772
91667357|NCT00762411|183228594|SUPERIORITY_OR_OTHER|||||||0.326||95.0|||||ANCOVA|||||||0.326
91667358|NCT00762411|183228595|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||0.117
91667359|NCT00762411|183228604|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|||||||0.929
91667360|NCT00762411|183228605|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||||||0.437
91667361|NCT00762411|183228606|SUPERIORITY_OR_OTHER|||||||0.318||95.0|||||ANCOVA|||||||0.318
91667362|NCT00762411|183228607|SUPERIORITY_OR_OTHER|||||||0.417||95.0|||||ANCOVA|||||||0.417
91667363|NCT00762411|183228608|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Mixed Models Analysis|||||||0.805
91667364|NCT00762411|183228609|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||Mixed Models Analysis|||||||0.893
91667365|NCT02959840|183228610|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.|||||<|1e-05|||||||Chi-squared|||||||< 0.00001
91667366|NCT02959840|183228610|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||5e-05|||||||Chi-squared|||||||0.00005
91667367|NCT02959840|183228610|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
91667368|NCT02959840|183228611|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
91667369|NCT02959840|183228611|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0002|||||||Chi-squared|||||||0.0002
91667370|NCT02959840|183228611|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.8|||||||Chi-squared|||||||0.8
91667371|NCT02959840|183228612|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||4e-05|||||||Chi-squared|||||||0.00004
91667372|NCT02959840|183228612|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
91667373|NCT02959840|183228612|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.09|||||||Chi-squared|||||||0.09
91667374|NCT02959840|183228613|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
91667375|NCT02959840|183228613|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
91667376|NCT02959840|183228613|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
91633902|NCT01021293|183160841|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|-1.69|||||TWO_SIDED|95.0|-3.9|-0.44||||||Non-inferiority of Poliorix™ as compared to OPV||-0.44|-3.9|
91633903|NCT01491802|183160880|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.090
91633904|NCT01491802|183160881|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.680
91633905|NCT01491802|183160882|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.197
91633906|NCT01491802|183160883|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.006
91633907|NCT01491802|183160884|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.044
91633908|NCT01491802|183160885|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.573
91633909|NCT01491802|183160886|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.960
91667377|NCT02959840|183228614|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
91667378|NCT02959840|183228614|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
91667379|NCT02959840|183228614|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
91484514|NCT02992132|182842993|SUPERIORITY||Difference in LSM|1.0|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-8.5|10.5||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||10.5|-8.5|
91633910|NCT01491802|183160887|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.944
91633911|NCT01491802|183160888|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.028
91633912|NCT03993314|183160890|SUPERIORITY|||||||0.757||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients achieving a level of numbness of T6 or higher between the two groups.||||0.757
91633913|NCT03993314|183160891|SUPERIORITY|||||||0.186||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median level of numbness between the two groups.||||0.186
91633914|NCT03993314|183160892|SUPERIORITY|||||||0.132||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring epidural activation between the two groups.||||0.132
91633915|NCT03993314|183160893|SUPERIORITY|||||||0.833||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring supplemental IV sedation or general anesthesia between the two groups.||||0.833
91633916|NCT03993314|183160894|SUPERIORITY|||||||0.004||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.004
91633917|NCT03993314|183160895|SUPERIORITY|||||||0.674||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.674
91633918|NCT03993314|183160896|SUPERIORITY|||||||0.196|||||||Log Rank|||Log-rank test of the null hypothesis that there is no difference in the time to discharge from the Post Anesthesia Care Unit (PACU) between the two groups.||||0.196
91633919|NCT01005966|183160901|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.01||||0.2117|TWO_SIDED|95.0|-7.75|1.73||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.||1.73|-7.75|0.2117
91633920|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.0002|TWO_SIDED|95.0|4.27|13.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||13.66|4.27|0.0002
91667380|NCT02959840|183228615|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||1|||||||Chi-squared|||||||1
91667381|NCT02959840|183228615|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
91667382|NCT02959840|183228615|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
91484515|NCT02448810|182842995|OTHER||Hazard Ratio (HR)|0.8||||0.246|TWO_SIDED|70.0|0.5|1.1||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.1|0.5|0.246
91633921|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.57||||0.0557||95.0|-0.11|9.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||9.24|-0.11|0.0557
91633922|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.55|||<|0.0001|TWO_SIDED|95.0|18.86|28.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||28.24|18.86|<0.0001
91633923|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.4||||0.0625|TWO_SIDED|95.0|-0.23|9.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||9.03|-0.23|0.0625
91667383|NCT02959840|183228616|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
91667384|NCT02959840|183228616|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
91667385|NCT02959840|183228616|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
91667386|NCT02959840|183228617|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.008|||||||Chi-squared|||||||0.008
91667387|NCT02959840|183228617|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
91667388|NCT02959840|183228617|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.6|||||||Chi-squared|||||||0.6
91667389|NCT02959840|183228618|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
91667390|NCT02959840|183228618|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
91484516|NCT02448810|182842995|OTHER||Hazard Ratio (HR)|0.8||||0.354|TWO_SIDED|70.0|0.5|1.4||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.4|0.5|0.354
91633924|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.99|||<|0.0001|TWO_SIDED|95.0|14.36|23.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||23.61|14.36|<0.0001
91633925|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.59|||<|0.0001|TWO_SIDED|95.0|9.95|19.23||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||19.23|9.95|<0.0001
91633926|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.58||||0.0017|TWO_SIDED|95.0|2.88|12.27||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||12.27|2.88|0.0017
91633927|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.97|||<|0.0001|TWO_SIDED|95.0|7.31|16.64||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||16.64|7.31|<0.0001
91667391|NCT02959840|183228618|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
91667392|NCT02959840|183228619|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
91667393|NCT02959840|183228619|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
91667394|NCT02959840|183228619|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
91667395|NCT02959840|183228620|SUPERIORITY|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.02|||||||Fisher Exact|||||||0.02
91667396|NCT02959840|183228620|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
91667397|NCT02959840|183228620|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.3|||||||Fisher Exact|||||||0.3
91667398|NCT02959840|183228621|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
91667399|NCT02959840|183228621|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.5|||||||Fisher Exact|||||||0.5
91667400|NCT02959840|183228621|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.7|||||||Fisher Exact|||||||0.7
91667401|NCT04556734|183228622|OTHER|F-test|LS Mean Difference|-14.14||||0.2579|TWO_SIDED|95.0|-38.933|10.648|||Mixed Models Analysis|||Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||10.648|-38.933|0.2579
91667402|NCT04556734|183228622|OTHER|F-test|LS Mean Difference|-21.79||||0.0592|TWO_SIDED|95.0|-44.446|0.871|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||0.871|-44.446|0.0592
91667403|NCT04556734|183228623|OTHER|F-test|Least square (LS) Mean Difference|-9.23||||0.1283|TWO_SIDED|95.0|-21.217|2.748|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||2.748|-21.217|0.1283
91667404|NCT04556734|183228623|OTHER|F-test|LS Mean Difference|-8.99||||0.1057|TWO_SIDED|95.0|-19.936|1.962|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||1.962|-19.936|0.1057
91667405|NCT04556734|183228624|OTHER||Response rate difference|11.5||||0.4067|TWO_SIDED|95.0|-14.22|37.31||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||37.31|-14.22|0.4067
91667406|NCT04556734|183228624|OTHER||Response rate difference|17.5||||0.2171|TWO_SIDED|95.0|-8.23|43.19||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||43.19|-8.23|0.2171
91667407|NCT04556734|183228624|OTHER||Response rate difference|-0.8||||0.9425|TWO_SIDED|95.0|-23.18|21.48||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||21.48|-23.18|0.9425
91667408|NCT04556734|183228624|OTHER||Response rate difference|8.9||||0.4959|TWO_SIDED|95.0|-15.19|32.94||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||32.94|-15.19|0.4959
91667409|NCT04556734|183228624|OTHER||Response rate difference|5.6||||0.3576|TWO_SIDED|95.0|-5.39|16.59||P-values are based on the comparison of Etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||16.59|-5.39|0.3576
91667410|NCT04556734|183228624|OTHER||Response rate difference|8.3||||0.2904|TWO_SIDED|95.0|-3.43|20.12||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.||20.12|-3.43|0.2904
91667411|NCT01435824|183228637|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.1|||||TWO_SIDED|90.0|97.5|115.4||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.4|97.5|
91667412|NCT01435824|183228638|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.2|||||TWO_SIDED|90.0|97.5|115.7||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.7|97.5|
91692408|NCT03187301|183279689|NON_INFERIORITY|30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-1.6|6.7||||||||6.7|-1.6|
91792543|NCT02129777|183462749|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|2.143||0.459|TWO_SIDED|95.0|-2.65|5.84|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.84|-2.65|0.459
91527833|NCT06173570|182930688|SUPERIORITY||Mean Difference (Net)|-3.17||||0.568|TWO_SIDED|95.0|-14.08|7.73|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||7.73|-14.08|0.568
91633928|NCT01005966|183160902|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|26.56|||<|0.0001|TWO_SIDED|95.0|21.88|31.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||31.24|21.88|<0.0001
91633929|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.24||||0.7912|TWO_SIDED|95.0|-239.62|314.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.||314.09|-239.62|0.7912
91633930|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|532.61||||0.0002|TWO_SIDED|95.0|259.06|806.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.||806.16|259.06|0.0002
91633931|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|692.91|||<|0.0001|TWO_SIDED|95.0|418.73|967.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||967.09|418.73|<0.0001
91633932|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1879.4|||<|0.0001|TWO_SIDED|95.0|1605.75|2153.04||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2153.04|1605.75|<0.0001
91633933|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|495.38||||0.0005|TWO_SIDED|95.0|221.09|769.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.||769.66|221.09|0.0005
91633934|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|655.67|||<|0.0001|TWO_SIDED|95.0|382.41|928.93||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||928.93|382.41|<0.0001
91667413|NCT01435824|183228639|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|101.3|||||TWO_SIDED|90.0|89.4|114.9||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||114.9|89.4|
91792544|NCT02129777|183462749|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.161||0.094|TWO_SIDED|95.0|-0.63|7.93|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.93|-0.63|0.094
91633935|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1842.16|||<|0.0001|TWO_SIDED|95.0|1568.73|2115.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2115.60|1568.73|<0.0001
91633936|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.3||||0.2448|TWO_SIDED|95.0|-110.58|431.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||431.18|-110.58|0.2448
91484517|NCT00136604|182843003|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.|Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.||3.05|-1.53|
91484518|NCT00136604|182843005|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.||3.05|-1.53|
91667414|NCT01435824|183228640|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|107.9|||||TWO_SIDED|90.0|84.5|137.8||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||137.8|84.5|
91633937|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1346.79|||<|0.0001|TWO_SIDED|95.0|1076.46|1617.11||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1617.11|1076.46|<0.0001
91633938|NCT01005966|183160903|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1186.49|||<|0.0001|TWO_SIDED|95.0|915.38|1457.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1457.60|915.38|<0.0001
91633939|NCT01347931|183160904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|7.0|<|0.05|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided|||A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).||10|2|<0.05
91667415|NCT00117806|183228650|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||0.008
91667416|NCT01765751|183228652|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-0.1|5.6|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.6|-0.1|
91667417|NCT01765751|183228652|SUPERIORITY||Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|0.1|5.9|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.9|0.1|
91484519|NCT04795622|182843028|SUPERIORITY||Odds Ratio (OR)|1.3545|||||TWO_SIDED|95.0|0.753|2.4365||||||||2.4365|0.7530|
91484520|NCT04795622|182843029|SUPERIORITY||Point Estimate|-0.0856|||||TWO_SIDED|95.0|-0.2395|0.0683||||||X-axis||0.0683|-0.2395|
91484521|NCT04795622|182843029|SUPERIORITY||Point Estimate|-0.033|||||TWO_SIDED|95.0|-0.2268|0.1608||||||Y-axis||0.1608|-0.2268|
91714412|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|10.97||0.4338||95.0|-30.2|13.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-30.2|0.4338
91484522|NCT04795622|182843029|SUPERIORITY||Point Estimate|0.1791|||||TWO_SIDED|95.0|-0.1551|0.5133||||||Z-axis||0.5133|-0.1551|
91484523|NCT03963401|182843042|SUPERIORITY||Mean Difference (Final Values)|21.23|STANDARD_ERROR_OF_MEAN|10.51||0.1172|TWO_SIDED|90.0|3.94|38.52|||Normal approximation, Dunnett's method|||||38.52|3.94|0.1172
91484524|NCT03963401|182843042|SUPERIORITY||Median Difference (Final Values)|23.38|STANDARD_ERROR_OF_MEAN|8.58||0.0197|TWO_SIDED|90.0|9.26|37.5|||Normal approximation, Dunnett's Method|||||37.50|9.26|0.0197
91667418|NCT01765751|183228652|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-3.2|2.7|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||2.7|-3.2|
91667419|NCT01765751|183228653|SUPERIORITY||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|1.6|29.7|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||29.7|1.6|
91667420|NCT01765751|183228653|SUPERIORITY||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-3.7|23.3|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||23.3|-3.7|
91484525|NCT03963401|182843042|SUPERIORITY||Median Difference (Final Values)|31.29|STANDARD_ERROR_OF_MEAN|8.29||0.0006|TWO_SIDED|90.0|17.65|44.93|||Normal approximation, Dunnett's Method|||||44.93|17.65|0.0006
91484526|NCT03963401|182843043|SUPERIORITY||Mean Difference (Final Values)|20.95|STANDARD_ERROR_OF_MEAN|11.09||0.0588|TWO_SIDED|90.0|2.72|39.19|||Normal approximation method|||||39.19|2.72|0.0588
91633940|NCT01347931|183160905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|1.0|7.0|||t-test, 2 sided|||Two-tailed t test||7|1|<0.05
91633941|NCT01749930|183160912|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.||||||0.216||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol. Superiority of BOL-303259-X to timolol was demonstrated at 8 of 9 time points (exception at 8 am Week 2).|ANCOVA|||||||0.216
91633942|NCT01749930|183160913|OTHER|||||||0.084|||||||Chi-squared|||||||0.084
91633943|NCT01749930|183160914|OTHER|||||||0.007|||||||Chi-squared|||||||0.007
91633944|NCT01749930|183160915|OTHER||||||||||||||||||No statistical analysis was performed on these proportions|||
91633945|NCT00945945|183160916|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.105|TWO_SIDED|95.0|-0.07|0.75||P-value for Change from Baseline to Endpoint (BOCF).|ANCOVA|Main Effect Model: Change = Treatment + Pooled Investigator + Baseline (Type III sums of squares).|Least Squares Mean Difference = DLX30-PLA minus PLA-DLX60.|||0.75|-0.07|0.105
91667421|NCT01765751|183228653|SUPERIORITY||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-8.6|20.3|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||20.3|-8.6|
91667422|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-8.1|0.4|||||Pain Interference - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||0.4|-8.1|
91667423|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|95.0|-2.6|5.6|||||Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||5.6|-2.6|
91714413|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|10.99||0.0647||95.0|-42.0|1.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-42.0|0.0647
91633946|NCT00394654|183160927|SUPERIORITY_OR_OTHER|||||||0.168|||||||Univariate 2-sample t-test|||||||0.168
91633947|NCT00394654|183160928|SUPERIORITY_OR_OTHER|||||||0.254|||||||Univariate 2-sample t-test|||||||0.254
91633948|NCT00394654|183160929|SUPERIORITY_OR_OTHER|||||||0.677|||||||Univariate 2-sample t-test|||||||0.677
91633949|NCT00394654|183160930|SUPERIORITY_OR_OTHER|||||||0.318|||||||Univariate 2-sample t-test|||||||0.318
91633950|NCT00394654|183160931|SUPERIORITY_OR_OTHER|||||||0.798|||||||Univariate 2-sample t-test|||||||0.798
91633951|NCT00394654|183160932|SUPERIORITY_OR_OTHER|||||||0.766|||||||Univariate 2-sample t-test|||||||0.766
91633952|NCT03442595|183160956|OTHER|test of difference in change of A1C between the two groups|||||<|0.001|||||||t-test, 2 sided|||The study was powered to detect a difference of 0.5% in the change in A1C with SD = 2 with 80\& at alopha = 0.;05 with a sample size of 128 in each group (paired t-test). The study reaches 100% power to detect this observed difference with an alpha level of 0.01.||||<0.001
91633953|NCT02364999|183160995|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk difference for confirmed response. EU equivalence margins (95% CI in -13% to 13%).|Risk Difference (RD)|0.6531|||||TWO_SIDED|95.0|-6.608|7.9082|||||PF-06439535 vs Bevacizumab-EU|||7.9082|-6.6080|
91633954|NCT02364999|183160995|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. US equivalence margins (90% CI in 0.73 to 1.37).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|90.0|0.8856|1.1625|||||PF-06439535 vs Bevacizumab-EU|||1.1625|0.8856|
91633955|NCT02364999|183160995|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. Japan equivalence margins (95% CI in 0.729 to 1.371).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|95.0|0.8628|1.1933|||||PF-06439535 vs Bevacizumab-EU|||1.1933|0.8628|
91633956|NCT02364999|183160998|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.8||||0.1077|TWO_SIDED|95.0|0.608|1.051|||Log Rank|Stratified by smoking, sex and region.||||1.051|0.608|0.1077
91667424|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-9.8|1.0|||||Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||1.0|-9.8|
91667425|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-2.2|3.8|||||Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Function||3.8|-2.2|
91667426|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.9|3.2|||||Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Funtion||3.2|-2.9|
91667427|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.4|3.7|||||Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population|Physical Function||3.7|-2.4|
91484527|NCT03963401|182843043|SUPERIORITY||Median Difference (Final Values)|26.31|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|90.0|11.72|40.9|||Normal approximation method|||||40.90|11.72|0.0030
91484528|NCT03963401|182843043|SUPERIORITY||Median Difference (Final Values)|31.21|STANDARD_ERROR_OF_MEAN|8.68||0.0003|TWO_SIDED|90.0|16.93|45.5|||Normal approximation method|||||45.50|16.93|0.0003
91792545|NCT02129777|183462749|SUPERIORITY_OR_OTHER||LS Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|2.173||0.203|TWO_SIDED|95.0|-1.52|7.09|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.09|-1.52|0.203
91633957|NCT02364999|183160999|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.931||||0.4492||95.0|0.777|1.116|||Log Rank|Stratified by smoking, sex and region.||||1.116|0.777|0.4492
91633958|NCT02364999|183161000|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.918||||0.4726|TWO_SIDED|95.0|0.729|1.157|||Log Rank|Stratified by smoking, sex and region.||||1.157|0.729|0.4726
91633959|NCT01234337|183161006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973|||=|0.405618|TWO_SIDED|95.0|0.779|1.217||One-sided p-value from log rank test (stratified per randomization as in interactive voice response system \[IVRS\]).|Log Rank|||PFS was compared using a stratified log-rank test with a one-sided alpha of 0.005, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95 percent (%) CIs were calculated using the Cox model, stratified by the above factors. A Hazard ratio of less than (\<) 1 indicates superiority of Sorafenib + Capecitabine over Placebo + Capecitabine.||1.217|0.779|=0.405618
91633960|NCT01234337|183161007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||=|0.930088|TWO_SIDED|95.0|0.943|1.513||One-sided p-value from log rank test (stratified per randomization as in IVRS). OS was compared using a stratified log-rank test, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease.|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by randomization factors.|At the time of PFS final analysis, it was OS interim analysis (IA) with 285 total death events. According to protocol specified O'Brien-Fleming type alpha spending function and 285 death events at IA, the prespecified alpha for this analysis was 0.0075 (one-sided). A Hazard ratio \< 1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.513|0.943|=0.930088
91633961|NCT01234337|183161008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||=|0.2105|TWO_SIDED|95.0|0.723|1.146||One-sided p-value from log rank test (stratified per randomization as in IVRS).|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by the above factors.|TTP was compared using a stratified log-rank test with a one-sided alpha of 0.025, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. A Hazard ratio \<1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.146|0.723|=0.2105
91633962|NCT01234337|183161009|SUPERIORITY_OR_OTHER||Percent Difference|1.93|||=|0.257412|TWO_SIDED|95.0|-3.9|7.77||One-sided p-value from Cochran Mantel-Haenszel test (stratified per randomization as in IVRS)|Cochran-Mantel-Haenszel|||ORR and 95% CI based on Cochran Mantel-Haenszel Test stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. Difference = (Placebo + Capecitabine) - (Sorafenib + Capecitabine).||7.77|-3.9|=0.257412
91633963|NCT01234337|183161010|SUPERIORITY_OR_OTHER||Percent Difference|-2.34|||=|0.284674|TWO_SIDED|95.0|-10.4|5.72||One-sided p-value from Cochran-Mantel-Haenszel test (stratified per randomization as in IVRS).|Cochran-Mantel-Haenszel|||"DCR and 95% CI based on general association Cochran-Mantel-Haenszel statistic with one-sided alpha of 0.025 stratified by number of prior chemotherapies for metastatic disease, hormone receptor status, and region. Difference = Placebo + Capecitabine - Sorafenib + Capecitabine."||5.72|-10.4|=0.284674
91633964|NCT01234337|183161012|SUPERIORITY_OR_OTHER||LSM Difference|-0.441|||||TWO_SIDED|95.0|-0.967|0.086||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.086|-0.967|
91633965|NCT01234337|183161013|SUPERIORITY_OR_OTHER||LSM Difference|-0.025|||||TWO_SIDED|95.0|-0.053|0.002||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.002|-0.053|
91633966|NCT01234337|183161014|SUPERIORITY_OR_OTHER||LSM Difference|-1.696|||||TWO_SIDED|95.0|-3.619|0.227||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.227|-3.619|
91484529|NCT00337350|182843072|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
91484530|NCT00337350|182843073|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||||||.05
91484531|NCT00337350|182843074|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||||||0.21
91484532|NCT01231230|182843080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||< 0.001
91484533|NCT01231230|182843080|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||<0.001
91484534|NCT01231230|182843080|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||>0.05
91714414|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|10.61||0.5651||95.0|-27.0|14.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.8|-27.0|0.5651
91667428|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|1.1|10.5|||||Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||10.5|1.1|
91667429|NCT01765751|183228654|SUPERIORITY||Median Difference (Net)|3.3|||||TWO_SIDED|95.0|-1.5|8.2|||||Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||8.2|-1.5|
91667430|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||7.3|-2.3|
91714415|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|11.16||0.1634||95.0|-37.6|6.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.4|-37.6|0.1634
91714416|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|10.77||0.2209||95.0|-34.4|8.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.0|-34.4|0.2209
91633967|NCT01234337|183161015|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.14|||||TWO_SIDED|90.0|0.92|1.4||||||Statistical analysis for Cmax: 5-fluorouracil||1.40|0.92|
91633968|NCT01234337|183161015|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.29|||||TWO_SIDED|90.0|1.07|1.56||||||Statistical analysis for Cmax: Capecitabine||1.56|1.07|
91633969|NCT01234337|183161016|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.11|||||TWO_SIDED|90.0|0.95|1.3||||||Statistical analysis for AUC(0-tlast): 5-fluorouracil||1.30|0.95|
91633970|NCT01234337|183161016|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.39|||||TWO_SIDED|90.0|1.22|1.58||||||Statistical analysis for AUC(0-tlast): Capecitabine||1.58|1.22|
91633971|NCT02815982|183161069|SUPERIORITY||Mean Difference (Final Values)|-8.7|||<|0.05|TWO_SIDED|95.0|-14.6|-2.7|||t-test, 2 sided|||||-2.7|-14.6|<.05
91633972|NCT02815982|183161070|SUPERIORITY||Mean Difference (Final Values)|35.6|||<|0.001|TWO_SIDED|95.0|-559.0|630.2||p value was the actual signficance level|t-test, 2 sided|||We compared Post-intervention scores||630.2|-559.0|<.001
91633973|NCT02815982|183161071|SUPERIORITY||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|-2.3|3.3||controlling for caregiver BMI at baseline and PCS BMI percentile at baseline|t-test, 2 sided|||We compared Post-intervention BMI||3.3|-2.3|<.001
91633974|NCT02815982|183161072|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.03|TWO_SIDED|95.0|-5.4|5.2||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||5.2|-5.4|<.03
91633975|NCT02815982|183161073|SUPERIORITY||Mean Difference (Final Values)|3.5|||<|0.09|TWO_SIDED|95.0|-4.3|11.3||p \< .05 was threshold|t-test, 2 sided|||||11.3|-4.3|<.09
91633976|NCT02815982|183161074|SUPERIORITY||Mean Difference (Final Values)|-328.6|||<|0.08|TWO_SIDED|95.0|-2868.4|2211.2||p \< .05 threshold,|t-test, 2 sided|||We compared Post-intervention scores||2211.2|-2868.4|<.08
91633977|NCT02815982|183161075|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|0.01|0.11||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.11|.01|<.0001
91633978|NCT02815982|183161076|SUPERIORITY||Mean Difference (Final Values)|-2.85|||<|0.001|TWO_SIDED|95.0|-11.3|5.65||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||5.65|-11.3|<.001
91633979|NCT02815982|183161077|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.04|0.06||threshold p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.06|-.04|<.001
91633980|NCT02815982|183161078|SUPERIORITY||Mean Difference (Final Values)|-348.9|||<|0.12|TWO_SIDED|95.0|-2762.5|2064.8||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||2064.8|-2762.5|<.12
91667431|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|-0.9|3.5|||||Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||3.5|-0.9|
91667432|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.6|0.9|||||Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||0.9|-3.6|
91667433|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|2.7|||||TWO_SIDED|95.0|0.4|5.0|||||Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||5.0|0.4|
91667434|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-4.5|3.9|||||Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||3.9|-4.5|
91633981|NCT00598585|183161080|SUPERIORITY|unpaired test, the threshold for statistical significance was p= 0.05|||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91525818|NCT02567825|182927157|SUPERIORITY||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.26|0.44||||||Null hypothesis: There is no difference between the two groups in the proportion of episodes presenting with tympanic membrane bulging rather than otorrhea|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|0.44|0.26|
91667435|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.9|5.1|||||Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||5.1|-2.9|
91667436|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.7|2.9|||||Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||2.9|-5.7|
91667437|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-6.7|0.6|||||Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||0.6|-6.7|
91667438|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-4.1|2.6|||||Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||2.6|-4.1|
91667439|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-5.4|1.4|||||Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||1.4|-5.4|
91667440|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-4.5|4.9|||||Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||4.9|-4.5|
91667441|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-1.8|7.7|||||Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||7.7|-1.8|
91667442|NCT01765751|183228654|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-7.6|2.0|||||Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||2.0|-7.6|
91667443|NCT00452348|183228677|SUPERIORITY_OR_OTHER||Least Squares Mean|0.04||||0.09||95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.090
91667444|NCT01390415|183228682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0374||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0374
91667445|NCT01390415|183228683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0566||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0566
91667446|NCT02898740|183228709|OTHER||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-6.8|0.0|||Mixed Models Analysis|models were adjusted for age|treatment difference = Exercise - Health Education|||-0.0|-6.8|<0.05
91667447|NCT01710358|183228710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|||||||0.001
91667448|NCT00880334|183228730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.939|TWO_SIDED|95.0|0.69|1.49|||Log Rank|||The study was designed with 80% power to detect 60% improvement in median PFS from 18 to 28.8 weeks (Vandetanib+docetaxel/Placebo+docetaxel hazard ratio of 0.625) with the addition of Vandetanib while maintaining an overall significance level of 5% in a one-sided test. This assumed exponential distribution of events, accrual of 1.75 patients per week (7-8 patients per month) for 78 weeks with 34 weeks of additional follow-up (112 weeks total). Full information was 118 PFS events.||1.49|0.69|0.939
91667449|NCT00880334|183228732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.873|TWO_SIDED|95.0|0.81|1.79|||Log Rank|||||1.79|0.81|.873
91667450|NCT00880334|183228733|SUPERIORITY_OR_OTHER|||||||0.56|||||||Fisher Exact|||||||0.56
91667451|NCT00880334|183228734|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher Exact|||||||0.31
91667452|NCT02951195|183228781|SUPERIORITY||LS Mean Difference|6.4||||0.0207|TWO_SIDED|95.0|0.3|12.6|||Mixed-effects Model for Repeated Measure|||||12.6|0.3|0.0207
91667453|NCT02951195|183228781|SUPERIORITY||LS Mean Difference|10.5||||0.0002|TWO_SIDED|95.0|5.0|15.9|||Mixed-effects Model for Repeated Measure|||||15.9|5.0|0.0002
91667454|NCT02951195|183228781|SUPERIORITY||LS Mean Difference|8.8||||0.0019|TWO_SIDED|95.0|3.0|14.5|||Mixed-effects Model for Repeated Measure|||||14.5|3.0|0.0019
91667455|NCT02951195|183228781|SUPERIORITY||LS Mean Difference|8.3||||0.054|TWO_SIDED|95.0|-2.1|18.7|||Mixed-effects Model for Repeated Measure|||||18.7|-2.1|0.0540
91667456|NCT02951195|183228782|SUPERIORITY||LS Mean Difference|8.7||||0.0007|TWO_SIDED|95.0|3.7|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.7|0.0007
91667457|NCT02951195|183228783|SUPERIORITY||Least Squares (LS) Mean Difference|-19.5||||0.0018|TWO_SIDED|95.0|-32.2|-6.8|||Mixed-effects Model for Repeated Measure|||||-6.8|-32.2|0.0018
91667458|NCT02951195|183228783|SUPERIORITY||LS Mean Difference|-13.6||||0.0106|TWO_SIDED|95.0|-25.0|-2.1|||Mixed-effects Model for Repeated Measure|||||-2.1|-25.0|0.0106
91667459|NCT02951195|183228783|SUPERIORITY||LS Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-38.6|-16.3|||Mixed-effects Model for Repeated Measure|||||-16.3|-38.6|<0.0001
91667460|NCT02951195|183228783|SUPERIORITY||LS Mean Difference|-24.8||||0.0017|TWO_SIDED|95.0|-40.0|-9.7|||Mixed-effects Model for Repeated Measure|||||-9.7|-40.0|0.0017
91667461|NCT02951195|183228784|SUPERIORITY||LS Mean Difference|-23.9|||<|0.0001|TWO_SIDED|95.0|-33.7|-14.1|||Mixed-effects Model for Repeated Measure|||||-14.1|-33.7|<0.0001
91667462|NCT02951195|183228785|SUPERIORITY||LS Mean Difference|12.5||||0.0166|TWO_SIDED|95.0|1.1|24.0|||Mixed-effects Model for Repeated Measure|||||24.0|1.1|0.0166
91667463|NCT02951195|183228785|SUPERIORITY||LS Mean Difference|21.3|||<|0.0001|TWO_SIDED|95.0|11.2|31.4|||Mixed-effects Model for Repeated Measure|||||31.4|11.2|<0.0001
91667464|NCT02951195|183228785|SUPERIORITY||LS Mean Difference|17.1||||0.0013|TWO_SIDED|95.0|6.3|27.8|||Mixed-effects Model for Repeated Measure|||||27.8|6.3|0.0013
91667465|NCT02951195|183228785|SUPERIORITY||LS Mean Difference|14.5||||0.0563|TWO_SIDED|95.0|-3.8|32.9|||Mixed-effects Model for Repeated Measure|||||32.9|-3.8|0.0563
91667466|NCT02951195|183228786|SUPERIORITY||LS Mean Difference|13.6||||0.0012|TWO_SIDED|95.0|5.3|21.9|||Mixed-effects Model for Repeated Measure|||||21.9|5.3|0.0012
91633982|NCT01795716|183161083|NON_INFERIORITY_OR_EQUIVALENCE|The 90%CIs of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|||||<|0.05|TWO_SIDED||||||ANOVA|||The 90% confidence intervals of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.||||<0.05
91633983|NCT00135694|183161093|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-13.0|||||TWO_SIDED|90.0|-35.0|10.0||||||||10|-35|
91633984|NCT00135694|183161099|SUPERIORITY_OR_OTHER|||||||0.0183|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||0.0183
91633985|NCT00135694|183161100|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||<0.0001
91633986|NCT02584660|183161101|SUPERIORITY||Mean difference|-1.202|||<|0.0001|TWO_SIDED|95.0|-1.73|-0.674|||t-test|||||-0.674|-1.730|<.0001
91633987|NCT00461552|183161107|SUPERIORITY|||||||0.84||||||Treatment time month interaction|Mixed Models Analysis|||||||0.84
91633988|NCT00461552|183161108|OTHER|||||||0.4||||||Treatment time month interaction|Mixed Models Analysis|||||||0.4
91633989|NCT00374452|183161113|OTHER||||||>|0.1|||||||Mixed Models Analysis|||We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.||||>0.1
91633990|NCT04623255|183161143|SUPERIORITY|||||||0.16|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in at least two inflammation markers' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.16
91633991|NCT04623255|183161144|SUPERIORITY|||||||0.606|TWO_SIDED|95.0|||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker CRP' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.606
91633992|NCT04623255|183161145|SUPERIORITY|||||||0.245|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker D-Dimer' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.245
91633993|NCT04623255|183161146|SUPERIORITY|||||||0.653|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker LDH' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.653
91633994|NCT00998985|183161177|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.46|||||TWO_SIDED|90.0|2.89|4.03|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.03|2.89|
91633995|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|4.68|||||TWO_SIDED|90.0|4.11|5.25|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.25|4.11|
91633996|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|4.87|||||TWO_SIDED|90.0|4.3|5.44|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.44|4.30|
91633997|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|4.35|||||TWO_SIDED|90.0|3.78|4.92|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.92|3.78|
91667467|NCT02951195|183228787|SUPERIORITY||LS Mean Difference|14.1||||0.0476|TWO_SIDED|95.0|-2.6|30.9|||ANCOVA|||||30.9|-2.6|0.0476
91667468|NCT02951195|183228787|SUPERIORITY||LS Mean Difference|29.4||||0.0001|TWO_SIDED|95.0|14.8|44.0|||ANCOVA|||||44.0|14.8|0.0001
91667469|NCT02951195|183228787|SUPERIORITY||LS Mean Difference|26.2||||0.0006|TWO_SIDED|95.0|11.3|41.1|||ANCOVA|||||41.1|11.3|0.0006
91667470|NCT02951195|183228787|SUPERIORITY||LS Mean Difference|4.8||||0.2714|TWO_SIDED|95.0|-11.6|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|-11.6|0.2714
91667471|NCT02951195|183228788|SUPERIORITY||LS Mean Difference|11.3||||0.0138|TWO_SIDED|95.0|1.3|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|1.3|0.0138
91667472|NCT04281472|183228851|SUPERIORITY||Hazard Ratio (HR)|0.394|||||TWO_SIDED|95.0|0.253|0.614||||||||0.614|0.253|
91667473|NCT05053360|183228907|SUPERIORITY||Odds Ratio (OR)|2.87||||0.019|TWO_SIDED|95.0|1.19|6.93|||Regression, Logistic|||HIGH PAIN = score over 6 on a 0-10 pain scale (higher number indicating higher pain)||6.93|1.19|.019
91667474|NCT05053360|183228908|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.0002|TWO_SIDED|95.0|-3.47|-1.09|||ANCOVA|||||-1.09|-3.47|.0002
91667475|NCT03277248|183228915|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.509||||0.0022|TWO_SIDED|95.0|0.33|0.784||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.784|0.330|0.0022
91792546|NCT02129777|183462750|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.7||0.448|TWO_SIDED|95.0|-1.92|0.86|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.86|-1.92|0.448
91792547|NCT02129777|183462750|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.692||0.099|TWO_SIDED|95.0|-2.53|0.22|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.22|-2.53|0.099
91484535|NCT01610271|182843081|SUPERIORITY|ABS was expected to be superior to Control.|Odds Ratio (OR)|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|0.01|2.05||a priori threshold was 0.05|Regression, Logistic|penalized maximum likelihood (Firth) logistic regression, because infection rate was very low (\<3%), as expected|The dispersion is the SE of the OR. ABS was the numerator group, Control was the denominator.|A sample size of 150 per group provided a power of 80% to detect a statistically significant (α≤0.05) 3% difference in SSI rate based on a historical infection rate of 6% in the facility where operations were performed.||2.05|0.01|0.067
91484536|NCT02038452|182843093|SUPERIORITY||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.16|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.16|-0.48|<0.001
91525819|NCT02567825|182927158|SUPERIORITY||Difference of least-squares means|5.21|||||TWO_SIDED|95.0|2.6|7.82|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience tube otorrhea. The analysis uses a weighted regression model with weights equal to the length of follow-up.||7.82|2.60|
91633998|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|5.15|||||TWO_SIDED|90.0|4.58|5.72|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.72|4.58|
91633999|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|4.76|||||TWO_SIDED|90.0|4.19|5.33|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.33|4.19|
91634000|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|4.93|||||TWO_SIDED|90.0|4.36|5.5|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.50|4.36|
91634001|NCT00998985|183161177|SUPERIORITY_OR_OTHER||LSM Difference|5.34|||||TWO_SIDED|90.0|4.93|5.74|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.74|4.93|
91634002|NCT00998985|183161178|SUPERIORITY_OR_OTHER||LSM Difference|2.25|||||TWO_SIDED|90.0|1.7|2.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||2.81|1.70|
91634003|NCT00998985|183161178|SUPERIORITY_OR_OTHER||LSM Difference|2.94|||||TWO_SIDED|90.0|2.38|3.49|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||3.49|2.38|
91634004|NCT00998985|183161178|SUPERIORITY_OR_OTHER||LSM Difference|3.84|||||TWO_SIDED|90.0|3.29|4.4|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.40|3.29|
91634005|NCT00998985|183161178|SUPERIORITY_OR_OTHER||LSM difference|4.98|||||TWO_SIDED|90.0|4.42|5.53|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||5.53|4.42|
91634006|NCT00998985|183161178|SUPERIORITY_OR_OTHER||LSM difference|4.21|||||TWO_SIDED|90.0|3.6|4.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.81|3.60|
91634007|NCT01040728|183161185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.163|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.231|0.163|<0.0001
91634008|NCT01040728|183161185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.186|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.255|0.186|<0.0001
91527834|NCT06173570|182930688|SUPERIORITY||Mean Difference (Net)|-4.98||||0.363|TWO_SIDED|95.0|-15.71|5.75|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||5.75|-15.71|0.363
91792548|NCT02129777|183462750|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.69||0.396|TWO_SIDED|95.0|-1.96|0.78|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.78|-1.96|0.396
91634009|NCT01040728|183161185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.187|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.255|0.187|<0.0001
91634010|NCT01040728|183161186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.117|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.188|0.117|<0.0001
91634011|NCT01040728|183161186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.134|0.205|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.205|0.134|<0.0001
91634012|NCT01040728|183161186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.128|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.128|<0.0001
91634013|NCT01040728|183161187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.141|0.208|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.208|0.141|<0.0001
91634014|NCT01040728|183161187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.157|0.225|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.225|0.157|<0.0001
91634015|NCT01040728|183161187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.159|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.226|0.159|<0.0001
91634016|NCT01040728|183161188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.181|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.248|0.181|<0.0001
91634017|NCT01040728|183161188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.205|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.272|0.205|<0.0001
91634018|NCT01040728|183161188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.119|<0.0001
91634019|NCT01040728|183161189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.178|0.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.251|0.178|<0.0001
91634020|NCT01040728|183161189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.208|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.208|<0.0001
91634021|NCT01040728|183161189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.199|0.271|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.271|0.199|<0.0001
91634022|NCT01040728|183161190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.201|0.273|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.273|0.201|<0.0001
91634023|NCT01040728|183161190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.23|0.302|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.302|0.230|<0.0001
91634024|NCT01040728|183161190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.138|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.211|0.138|<0.0001
91634025|NCT01040728|183161191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.169|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.246|0.169|<0.0001
91667476|NCT03277248|183228916|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.035|||<|0.0001|TWO_SIDED|95.0|0.019|0.064||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.064|0.019|<.0001
91667477|NCT03277248|183228917|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.1|||<|0.0001|TWO_SIDED|95.0|0.073|0.136||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.136|0.073|<.0001
91667478|NCT03277248|183228919|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|7.946|||<|0.0001|TWO_SIDED|95.0|4.917|12.841||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1-unenhancing, T2, Gd-enhancing) as covariates.|Regression, Logistic|||||12.841|4.917|<.0001
91667479|NCT03277248|183228920|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|0.862||||0.429|TWO_SIDED|95.0|0.596|1.246||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||1.246|0.596|0.4290
91667480|NCT03277248|183228921|SUPERIORITY||Least Squares Mean Difference|-0.018||||0.3108|TWO_SIDED|95.0|-0.053|0.017||Mixed model repeated measures (MMRM) model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures|||||0.017|-0.053|0.3108
91667481|NCT01993940|183228923|SUPERIORITY_OR_OTHER||Difference|18.9|STANDARD_ERROR_OF_MEAN|4.12|<|0.0001|TWO_SIDED|95.0|10.8|27.0||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||27.0|10.8|<0.0001
91667482|NCT01993940|183228924|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|0.92|1.88|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.88|0.92|<0.0001
91667483|NCT01993940|183228925|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|1.63|2.71|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.71|1.63|<0.0001
91667484|NCT01993940|183228926|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|0.7|1.61|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.61|0.70|<0.0001
91792549|NCT02129777|183462750|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.697||0.102|TWO_SIDED|95.0|-2.54|0.23|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.23|-2.54|0.102
91484537|NCT02038452|182843094|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.53|-0.17|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.17|-0.53|<0.001
91484538|NCT02038452|182843095|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.43|-0.09|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.09|-0.43|0.003
91484539|NCT02038452|182843096|SUPERIORITY||Mean Difference (Final Values)|-0.97||||0.005|TWO_SIDED|95.0|-1.64|-0.3|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.30|-1.64|0.005
91667485|NCT01993940|183228927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.227||0.0011|TWO_SIDED|95.0|0.3|1.19|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.19|0.30|0.0011
91667486|NCT01949532|183228928|SUPERIORITY_OR_OTHER||Ratio of geometric means|132.75|||||TWO_SIDED|90.0|70.6|249.63|||||The point estimates of the geometric mean ratios for the PK parameters were calculated by exponentiation of the differences in the least-squares means between the renal impairment group (test) and participants with normal renal function (reference).|||249.63|70.60|
91667487|NCT01949532|183228929|SUPERIORITY_OR_OTHER||Ratio of geometric means|133.62|||||TWO_SIDED|90.0|70.93|251.73||||||||251.73|70.93|
91667488|NCT01277510|183229021|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|35.5||||0.017|TWO_SIDED|95.0|8.76|62.24|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm's method at 0.05 should the primary endpoint achieve a significant result.||62.24|8.76|0.017
91667489|NCT01277510|183229022|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|3.46||||0.826|TWO_SIDED|95.0|-22.58|29.51|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||29.51|-22.58|0.826
91692409|NCT03187301|183279689|NON_INFERIORITY|45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.4||||||||7.4|-0.9|
91484540|NCT02038452|182843097|SUPERIORITY||Odds Ratio (OR)|0.44||||0.018|TWO_SIDED|95.0|0.22|0.87|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.87|0.22|0.018
91634026|NCT01040728|183161191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.205|<0.0001
91714417|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|10.84||0.1293||95.0|-37.8|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-37.8|0.1293
91634027|NCT01040728|183161191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.282|0.205|<0.0001
91634028|NCT01040728|183161192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.097|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.171|0.097|<0.0001
91634029|NCT01040728|183161192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.105|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.181|0.105|<0.0001
91634030|NCT01040728|183161192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.195|0.120|<0.0001
91634031|NCT01040728|183161193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.276|0.384|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.384|0.276|<0.0001
91634032|NCT01040728|183161193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.326|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.272|0.381|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.381|0.272|<0.0001
91634033|NCT01040728|183161193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.316|0.424|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.424|0.316|<0.0001
91634034|NCT01040728|183161194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.214|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.342|0.214|<0.0001
91484541|NCT02038452|182843100|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.23|-0.11|0.500
91634035|NCT01040728|183161194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.2|0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.329|0.200|<0.0001
91634036|NCT01040728|183161194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.238|0.366|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.366|0.238|<0.0001
91634037|NCT01040728|183161195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.244|0.363|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.363|0.244|<0.0001
91634038|NCT01040728|183161195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.222|0.343|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.343|0.222|<0.0001
91634039|NCT01040728|183161195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.275|0.395|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.395|0.275|<0.0001
91634040|NCT01040728|183161196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.309|0.43|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.430|0.309|<0.0001
91634041|NCT01040728|183161196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.366|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.306|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.426|0.306|<0.0001
91634042|NCT01040728|183161196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.202|0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.322|0.202|<0.0001
91634043|NCT01040728|183161197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.344|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.287|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.401|0.287|<0.0001
91634044|NCT01040728|183161197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.296|0.411|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.411|0.296|<0.0001
91634045|NCT01040728|183161197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.314|0.427|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.427|0.314|<0.0001
91634046|NCT01040728|183161198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.272|0.396|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.396|0.272|<0.0001
91634047|NCT01040728|183161198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.346|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.283|0.408|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.408|0.283|<0.0001
91634048|NCT01040728|183161198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.316|0.44|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.440|0.316|<0.0001
91634049|NCT01040728|183161199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.179|0.309|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.309|0.179|<0.0001
91634050|NCT01040728|183161199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.15|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.150|<0.0001
91634051|NCT01040728|183161199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.191|0.321|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.321|0.191|<0.0001
91634052|NCT01855867|183161207|SUPERIORITY|Statistical significance was determined at the alpha 0.05 level. The study regimen completion rates of participants in the current study taking a fixed dose once daily combination of elvitegravir/cobicistat/TDF/FTC were compared to historical controls who used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using chi-square tests for independence.|chi square||||<|0.05||||||Reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|Chi-squared|||using historical controls||||<0.05
91634053|NCT00542425|183161209|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
91634054|NCT00542425|183161209|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
91634055|NCT00542425|183161210|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
91634056|NCT00542425|183161210|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
91634057|NCT01424306|183161214|OTHER|||||||0.403||||||P value for the time x diet interaction reflects overall comparison of 3 dietary phases by RM-ANOVA|RM-ANOVA|||RM-ANOVA||||0.403
91634058|NCT01424306|183161215|OTHER|RM-ANOVA||||||0.933||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.933
91634059|NCT01424306|183161216|OTHER|RM-ANOVA||||||0.196||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.196
91634060|NCT01424306|183161217|OTHER|RM-ANOVA||||||0.88||||||Reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.880
91634061|NCT01424306|183161218|OTHER|RM-ANOVA|||||<|0.001||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|Repeated measures ANOVA|||||||<0.001
91634062|NCT01424306|183161219|OTHER|RM-ANOVA||||||0.366||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.366
91634063|NCT01424306|183161220|OTHER|RM-ANOVA||||||0.387||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.387
91484542|NCT02038452|182843101|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.21|TWO_SIDED|95.0|-0.07|0.33|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms||The main treatment analyses were based on intention to treat approach||0.33|-0.07|0.21
91634064|NCT01424306|183161221|OTHER|RM-ANOVA||||||0.476||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.476
91634065|NCT01424306|183161222|OTHER|RM-ANOVA||||||0.596||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.596
91634066|NCT01424306|183161223|OTHER|RM-ANOVA||||||0.492||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.492
91634067|NCT01424306|183161224|OTHER|RM-ANOVA||||||0.149||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.149
91634068|NCT01424306|183161225|OTHER|RM-ANOVA||||||0.056||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.056
91634069|NCT01424306|183161226|OTHER|RM-ANOVA||||||0.52||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.520
91634070|NCT01601873|183161230|SUPERIORITY|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||||||0.884
91667490|NCT01277510|183229023|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.7||||0.147|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||1.3|-8.6|0.147
91484543|NCT02038452|182843102|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.96|TWO_SIDED|95.0|-0.175|0.166|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.166|-0.175|0.96
91484544|NCT02038452|182843103|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.055|TWO_SIDED|95.0|-0.02|1.59|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||1.59|-0.02|0.055
91634071|NCT01601873|183161231|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
91634072|NCT01601873|183161232|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
91634073|NCT01601873|183161233|SUPERIORITY|||||||0.538|||||||Log Rank|||||||0.538
91634074|NCT01601873|183161234|SUPERIORITY|||||||0.786|||||||Log Rank|||||||0.786
91634075|NCT01601873|183161235|SUPERIORITY|||||||0.185|||||||Log Rank|||||||0.185
91634076|NCT02096471|183161245|SUPERIORITY|Single group study. Change in Pain from Baseline amongst those with a tumor response|Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.84||0.11|TWO_SIDED||||||t-test, 2 sided|Descriptive analysis only||Single group change from baseline||||0.11
91634077|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.01
91634078|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.66||0.18|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.18
91634079|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life (QOL) from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.77|STANDARD_ERROR_OF_MEAN|3.6||0.3|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.30
91634080|NCT02096471|183161245|SUPERIORITY|Single Group Study Change in Quality of Life from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|6.87||0.61|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.61
91634081|NCT02096471|183161245|SUPERIORITY|Single Group Study Change in Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-13.06|STANDARD_ERROR_OF_MEAN|8.29||0.12|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.12
91634082|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-12.98|STANDARD_ERROR_OF_MEAN|6.35||0.05|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only.||Single Group Change from Baseline||||0.05
91634083|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|6.66|STANDARD_ERROR_OF_MEAN|5.05||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
91634084|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|6.46||0.72|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.72
91634085|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|6.74||0.36|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.36
91634086|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|6.37||0.98|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.98
91634087|NCT02096471|183161245|SUPERIORITY|Single Group Study. change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|7.99||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
91484545|NCT02038452|182843104|SUPERIORITY||Odds Ratio (OR)|1.12||||0.76|TWO_SIDED|95.0|0.55|2.2|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||2.20|0.55|0.76
91484546|NCT02038452|182843105|SUPERIORITY||Odds Ratio (OR)|1.66||||0.23|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.77|0.73|0.23
91484547|NCT02038452|182843106|SUPERIORITY||Odds Ratio (OR)|1.28||||0.66|TWO_SIDED|95.0|0.41|3.98|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.98|0.41|0.66
91527835|NCT06173570|182930688|SUPERIORITY||Mean Difference (Net)|-6.73||||0.223|TWO_SIDED|95.0|-17.57|4.11|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||4.11|-17.57|0.223
91634088|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-10.97|STANDARD_ERROR_OF_MEAN|8.16||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
91634089|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|6.58||0.57|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.57
91634090|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|5.51||0.45|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.45
91634091|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|5.72||0.28|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.28
91634092|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|8.52||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
91634093|NCT02096471|183161245|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|7.53||0.89|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.89
91634094|NCT02483611|183161270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.0|STANDARD_DEVIATION|46.07||0.9651|TWO_SIDED|95.0|88.0|235.0|||ANOVA|||||235|88|0.9651
91634095|NCT02483611|183161270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.3|STANDARD_DEVIATION|42.48||0.9651|TWO_SIDED|95.0|78.0|244.0|||ANOVA|||||244|78|0.9651
91634096|NCT02483611|183161270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|147.8|STANDARD_DEVIATION|29.75||0.9651|TWO_SIDED|95.0|105.0|200.0|||ANOVA|||The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.||200|105|0.9651
91634097|NCT02483611|183161271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|82.68|||<|0.0001|TWO_SIDED|95.0|72.62|99.27|||Kruskal-Wallis|||||99.27|72.62|<0.0001
91634098|NCT02483611|183161271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|86.33|||<|0.0001|TWO_SIDED|95.0|71.78|140.6|||Kruskal-Wallis|||||140.60|71.78|<0.0001
91634099|NCT02483611|183161271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|40.5|92.9|||Kruskal-Wallis|||||92.90|40.50|<0.0001
91634100|NCT02483611|183161272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.08|STANDARD_DEVIATION|6.49||0.0015|TWO_SIDED|95.0|12.0|32.25|||ANOVA|||||32.25|12.00|0.0015
91634101|NCT02483611|183161272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.26|STANDARD_DEVIATION|7.69||0.0015|TWO_SIDED|95.0|10.5|39.83|||ANOVA|||||39.83|10.50|0.0015
91634102|NCT02483611|183161272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.53|STANDARD_DEVIATION|1.52||0.0015|TWO_SIDED|95.0|11.0|16.5|||ANOVA|||||16.50|11.00|0.0015
91634103|NCT02483611|183161273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.97|STANDARD_DEVIATION|6.77||0.0003|TWO_SIDED|95.0|19.5|41.5|||ANOVA|||||41.50|19.50|0.0003
91634104|NCT02483611|183161273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.81|STANDARD_DEVIATION|10.97||0.0003|TWO_SIDED|95.0|18.5|49.5|||ANOVA|||||49.50|18.50|0.0003
91634105|NCT02483611|183161273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|STANDARD_DEVIATION|3.28||0.0003|TWO_SIDED|95.0|17.5|30.05|||ANOVA|||||30.05|17.50|0.0003
91634106|NCT02483611|183161274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.2|STANDARD_DEVIATION|12.16|<|0.0001|TWO_SIDED|95.0|94.87|136.8|||ANOVA|||||136.80|94.87|<0.0001
91634107|NCT02483611|183161274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.1|STANDARD_DEVIATION|18.2|<|0.0001|TWO_SIDED|95.0|95.82|163.3|||ANOVA|||||163.30|95.82|<0.0001
91634108|NCT02483611|183161274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.19|STANDARD_DEVIATION|16.34|<|0.0001|TWO_SIDED|95.0|58.0|125.2|||ANOVA|||||125.20|58|<0.0001
91634109|NCT02483611|183161275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.2|STANDARD_DEVIATION|10.88|<|0.0001|TWO_SIDED|95.0|106.3|140.2|||ANOVA|||||140.20|106.30|<0.0001
91634110|NCT02483611|183161275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|126.7|STANDARD_DEVIATION|14.19|<|0.0001|TWO_SIDED|95.0|106.5|149.4|||ANOVA|||||149.40|106.50|<0.0001
91634111|NCT02483611|183161275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.03|STANDARD_DEVIATION|12.78|<|0.0001|TWO_SIDED|95.0|71.75|116.4|||ANOVA|||||116.40|71.75|<0.0001
91634112|NCT02483611|183161276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.63|STANDARD_DEVIATION|10.18||0.0527|TWO_SIDED|95.0|70.0|112.0|||ANOVA|||||112.00|70.00|0.0527
91484548|NCT02038452|182843107|SUPERIORITY||Odds Ratio (OR)|1.43||||0.66|TWO_SIDED|95.0|0.28|7.34|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||7.34|0.28|0.66
91484549|NCT02038452|182843108|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.18|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.18|0.63|0.40
91484550|NCT02038452|182843109|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2|TWO_SIDED|95.0|0.7|5.66|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||5.66|0.70|0.20
91634113|NCT02483611|183161276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.75|STANDARD_DEVIATION|10.05||0.0527|TWO_SIDED|95.0|65.0|104.0|||ANOVA|||||104.00|65.00|0.0527
91634114|NCT02483611|183161276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.1|STANDARD_DEVIATION|16.62||0.0527|TWO_SIDED|95.0|70.0|140.0|||ANOVA|||||140.00|70.00|0.0527
91634115|NCT02483611|183161277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.63|STANDARD_DEVIATION|12.1||0.1996|TWO_SIDED|95.0|60.0|110.0|||ANOVA|||||110.00|60.00|0.1996
91634116|NCT02483611|183161277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.69|STANDARD_DEVIATION|11.38||0.1996|TWO_SIDED|95.0|67.0|109.0|||ANOVA|||||109.00|67.00|0.1996
91634117|NCT02483611|183161277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.47|STANDARD_DEVIATION|12.3||0.1996|TWO_SIDED|95.0|73.0|112.0|||ANOVA|||||112.00|73.00|0.1996
91634118|NCT02483611|183161278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.88|STANDARD_DEVIATION|11.95||0.7145|TWO_SIDED|95.0|58.0|107.0|||ANOVA|||||107.00|58.00|0.7145
91634119|NCT02483611|183161278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.88|STANDARD_DEVIATION|9.8||0.7145|TWO_SIDED|95.0|59.0|97.0|||ANOVA|||||97.00|59.00|0.7145
91634120|NCT02483611|183161278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.73|STANDARD_DEVIATION|7.48||0.7145|TWO_SIDED|95.0|58.0|86.0|||ANOVA|||||86.00|58.00|0.7145
91634121|NCT02483611|183161279|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.113|TWO_SIDED|95.0|57.0|96.0|||Kruskal-Wallis|||||96.00|57.00|0.1130
91634122|NCT02483611|183161279|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.113|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1130
91634123|NCT02483611|183161279|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|74.0||||0.113|TWO_SIDED|95.0|59.0|83.0|||Kruskal-Wallis|||||83.00|59.00|0.1130
91634124|NCT02483611|183161280|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.5||||0.0731|TWO_SIDED|95.0|58.0|98.0|||Kruskal-Wallis|||||98.00|58.00|0.0731
91634125|NCT02483611|183161280|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0731|TWO_SIDED|95.0|55.0|74.0|||Kruskal-Wallis|||||74.00|55.00|0.0731
91634126|NCT02483611|183161280|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|67.0||||0.0731|TWO_SIDED|95.0|56.0|85.0|||Kruskal-Wallis|||||85.00|56.00|0.0731
91484551|NCT02038452|182843110|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.001|TWO_SIDED|95.0|-0.53|-0.14||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.14|-0.53|0.001
91484552|NCT02038452|182843111|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.74|TWO_SIDED|95.0|-0.17|0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.24|-0.17|0.74
91634127|NCT02483611|183161281|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.1002|TWO_SIDED|95.0|60.0|85.0|||Kruskal-Wallis|||||85.00|60.00|0.1002
91634128|NCT02483611|183161281|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.1002|TWO_SIDED|95.0|56.0|74.0|||Kruskal-Wallis|||||74.00|56.00|0.1002
91634129|NCT02483611|183161281|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.1002|TWO_SIDED|95.0|60.0|90.0|||Kruskal-Wallis|||||90.00|60.00|0.1002
91634130|NCT02483611|183161282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.94|STANDARD_DEVIATION|15.79||0.4338|TWO_SIDED|95.0|52.0|109.0|||ANOVA|||||109.00|52.00|0.4338
91634131|NCT02483611|183161282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.25|STANDARD_DEVIATION|12.13||0.4338|TWO_SIDED|95.0|55.0|95.0|||ANOVA|||||95.00|55.00|0.4338
91634132|NCT02483611|183161282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.67|STANDARD_DEVIATION|11.82||0.4338|TWO_SIDED|95.0|55.0|92.0|||ANOVA|||||92.00|55.00|0.4338
91634133|NCT02483611|183161283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.69|STANDARD_DEVIATION|11.76||0.9167|TWO_SIDED|95.0|57.0|99.0|||ANOVA|||||99.00|57.00|0.9167
91634134|NCT02483611|183161283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.69|STANDARD_DEVIATION|11.18||0.9167|TWO_SIDED|95.0|51.0|96.0|||ANOVA|||||96.00|51.00|0.9167
91634135|NCT02483611|183161283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.9167|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.9167
91634136|NCT02483611|183161284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.94|STANDARD_DEVIATION|10.96||0.8067|TWO_SIDED|95.0|58.0|92.0|||ANOVA|||||92.00|58.00|0.8067
91634137|NCT02483611|183161284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.19|STANDARD_DEVIATION|8.65||0.8067|TWO_SIDED|95.0|57.0|86.0|||ANOVA|||||86.00|57.00|0.8067
91634138|NCT02483611|183161284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.8067|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.8067
91634139|NCT02483611|183161285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.94|STANDARD_DEVIATION|10.87||0.1015|TWO_SIDED|95.0|57.0|93.0|||ANOVA|||||93.00|57.00|0.1015
91634140|NCT02483611|183161285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.25|STANDARD_DEVIATION|9.78||0.1015|TWO_SIDED|95.0|52.0|89.0|||ANOVA|||||89.00|52.00|0.1015
91484553|NCT02038452|182843112|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.12|-0.30|0.41
91484554|NCT02038452|182843113|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.28|-0.16|0.58
91634141|NCT02483611|183161285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.07|STANDARD_DEVIATION|10.01||0.1015|TWO_SIDED|95.0|44.0|81.0|||ANOVA|||||81.00|44.00|0.1015
91634142|NCT02483611|183161286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.56|STANDARD_DEVIATION|10.05||0.3423|TWO_SIDED|95.0|56.0|92.0|||ANOVA|||||92.00|56.00|0.3423
91634143|NCT02483611|183161286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.31|STANDARD_DEVIATION|7.73||0.3423|TWO_SIDED|95.0|57.0|83.0|||ANOVA|||||83.00|57.00|0.3423
91634144|NCT02483611|183161286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.27|STANDARD_DEVIATION|10.81||0.3423|TWO_SIDED|95.0|41.0|81.0|||ANOVA|||||81.00|41.00|0.3423
91634145|NCT02483611|183161287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.5|STANDARD_DEVIATION|10.11||0.6817|TWO_SIDED|95.0|53.0|92.0|||ANOVA|||||92.00|53.00|0.6817
91634146|NCT02483611|183161287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.19|STANDARD_DEVIATION|8.4||0.6817|TWO_SIDED|95.0|54.0|82.0|||ANOVA|||||82.00|54.00|0.6817
91634147|NCT02483611|183161287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.13|STANDARD_DEVIATION|10.5||0.6817|TWO_SIDED|95.0|47.0|81.0|||ANOVA|||||81.00|47.00|0.6817
91634148|NCT02483611|183161288|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0937|TWO_SIDED|95.0|58.0|80.0|||Kruskal-Wallis|||||80.00|58.00|0.0937
91634149|NCT02483611|183161288|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0937|TWO_SIDED|95.0|56.0|90.0|||Kruskal-Wallis|||||90.00|56.00|0.0937
91634150|NCT02483611|183161288|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.0937|TWO_SIDED|95.0|58.0|87.0|||Kruskal-Wallis|||||87.00|58.00|0.0937
91634151|NCT02483611|183161289|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.1406|TWO_SIDED|95.0|60.0|88.0|||Kruskal-Wallis|||||88.00|60.00|0.1406
91634152|NCT02483611|183161289|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.5||||0.1406|TWO_SIDED|95.0|55.0|86.0|||Kruskal-Wallis|||||86.00|55.00|0.1406
91634153|NCT02483611|183161289|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.1406|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1406
91634154|NCT02483611|183161290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.25|STANDARD_DEVIATION|6.74||0.0504|TWO_SIDED|95.0|60.0|81.0|||ANOVA|||||81.00|60.00|0.0504
91634155|NCT02483611|183161290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.0|STANDARD_DEVIATION|7.62||0.0504|TWO_SIDED|95.0|49.0|79.0|||ANOVA|||||79.00|49.00|0.0504
91634156|NCT02483611|183161290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.0|STANDARD_DEVIATION|7.56||0.0504|TWO_SIDED|95.0|58.0|84.0|||ANOVA|||||84.00|58.00|0.0504
91634157|NCT02483611|183161291|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.0205|TWO_SIDED|95.0|60.0|93.0|||Kruskal-Wallis|||||93.00|60.00|0.0205
91634158|NCT02483611|183161291|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.0||||0.0205|TWO_SIDED|95.0|54.0|72.0|||Kruskal-Wallis|||||72.00|54.00|0.0205
91634159|NCT02483611|183161291|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0205|TWO_SIDED|95.0|59.0|75.0|||Kruskal-Wallis|||||75.00|59.00|0.0205
91634160|NCT02483611|183161292|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.3004|TWO_SIDED|95.0|58.0|86.0|||Kruskal-Wallis|||||86.00|58.00|0.3004
91634161|NCT02483611|183161292|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.3004|TWO_SIDED|95.0|56.0|78.0|||Kruskal-Wallis|||||78.00|56.00|0.3004
91634162|NCT02483611|183161292|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.3004|TWO_SIDED|95.0|62.0|81.0|||Kruskal-Wallis|||||81.00|62.00|0.3004
91634163|NCT02483611|183161293|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.0178|TWO_SIDED|95.0|60.0|84.0|||Kruskal-Wallis|||||84.00|60.00|0.0178
91634164|NCT02483611|183161293|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.0178|TWO_SIDED|95.0|51.0|75.0|||Kruskal-Wallis|||||75.00|51.00|0.0178
91634165|NCT02483611|183161293|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|72.0||||0.0178|TWO_SIDED|95.0|61.0|91.0|||Kruskal-Wallis|||||91.00|61.00|0.0178
91634166|NCT02483611|183161294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.67|STANDARD_DEVIATION|8.51||0.8746|TWO_SIDED|95.0|51.0|99.0|||ANOVA|||||99.00|51.00|0.8746
91634167|NCT02483611|183161294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.38|STANDARD_DEVIATION|6.96||0.8746|TWO_SIDED|95.0|56.0|82.0|||ANOVA|||||82.00|56.00|0.8746
91634168|NCT02483611|183161294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.4|STANDARD_DEVIATION|7.94||0.8746|TWO_SIDED|95.0|54.0|80.0|||ANOVA|||||80.00|54.00|0.8746
91634169|NCT02483611|183161295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.44|STANDARD_DEVIATION|10.95||0.4195|TWO_SIDED|95.0|47.0|92.0|||ANOVA|||||92.00|47.00|0.4195
91634170|NCT02483611|183161295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.38|STANDARD_DEVIATION|9.28||0.4195|TWO_SIDED|95.0|53.0|80.0|||ANOVA|||||80.00|53.00|0.4195
91634171|NCT02483611|183161295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.0|STANDARD_DEVIATION|8.23||0.4195|TWO_SIDED|95.0|52.0|80.0|||ANOVA|||||80.00|52.00|0.4195
91634172|NCT02483611|183161296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|11.52||0.5796|TWO_SIDED|95.0|47.0|93.0|||ANOVA|||||93.00|47.00|0.5796
91634173|NCT02483611|183161296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|10.19||0.5796|TWO_SIDED|95.0|48.0|79.0|||ANOVA|||||79.00|48.00|0.5796
91634174|NCT02483611|183161296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.33|STANDARD_DEVIATION|9.26||0.5796|TWO_SIDED|95.0|50.0|79.0|||ANOVA|||||79.00|50.00|0.5796
91634175|NCT02483611|183161297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.19|STANDARD_DEVIATION|12.82||0.5351|TWO_SIDED|95.0|45.0|92.0|||ANOVA|||||92.00|45.00|0.5351
91792550|NCT02129777|183462751|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.626||0.099|TWO_SIDED|95.0|-2.29|-0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.20|-2.29|0.099
91634176|NCT02483611|183161297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.31|STANDARD_DEVIATION|10.87||0.5351|TWO_SIDED|95.0|47.0|82.0|||ANOVA|||||82.00|47.00|0.5351
91634177|NCT02483611|183161297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|61.93|STANDARD_DEVIATION|9.0||0.5351|TWO_SIDED|95.0|51.0|79.0|||ANOVA|||||79.00|51.00|0.5351
91634178|NCT02483611|183161298|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.4988|TWO_SIDED|95.0|42.0|92.0|||Kruskal-Wallis|||||92.00|42.00|0.4988
91634179|NCT02483611|183161298|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.4988|TWO_SIDED|95.0|50.0|85.0|||Kruskal-Wallis|||||85.00|50.00|0.4988
91634180|NCT02483611|183161298|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|58.0||||0.4988|TWO_SIDED|95.0|51.0|80.0|||Kruskal-Wallis|||||80.00|51.00|0.4988
91634181|NCT02483611|183161299|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.7723|TWO_SIDED|95.0|43.0|89.0|||Kruskal-Wallis|||||89.00|43.00|0.7723
91634182|NCT02483611|183161299|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|51.0|82.0|||Kruskal-Wallis|||||82.00|51.00|0.7723
91634183|NCT02483611|183161299|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|50.0|78.0|||Kruskal-Wallis|||||78.00|50.00|0.7723
91634184|NCT02590406|183161300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|||We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.||||0.005
91667491|NCT01277510|183229024|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.3||||0.454|TWO_SIDED|95.0|-19.4|8.9|||ANCOVA|Baseline age group was used as covariate|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||8.9|-19.4|0.454
91634185|NCT02590406|183161301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91634186|NCT02590406|183161302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANOVA|||||||0.0003
91634187|NCT02590406|183161303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||ANOVA|||||||0.9
91634188|NCT02590406|183161304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||||||0.03
91634189|NCT00631969|183161306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.109|||<|0.0001||95.0|-8.562|-5.6561|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.6561|-8.562|< 0.0001
91634190|NCT00631969|183161307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.027|||<|0.0001||95.0|-35.519|-22.534|||ANCOVA|||Statistical analysis applies to the total population.||-22.534|-35.519|< 0.0001
91634191|NCT00631969|183161308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.193|||<|0.0001||95.0|-45.021|-31.366|||ANCOVA|||Statistical analysis applies to the total population.||-31.366|-45.021|< 0.0001
91634192|NCT00631969|183161309|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|34.778|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.||Statistical analysis applies to the total population.||||<0.0001
91634193|NCT00631969|183161310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.503|||<|0.0001||95.0|-22.424|-10.764|||ANCOVA|||Statistical analysis applies to the total population.||-10.764|-22.424|< 0.0001
91634194|NCT00631969|183161311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.167|||<|0.0001||95.0|-45.261|-31.073|||ANCOVA|||Statistical analysis applies to the total population.||-31.073|-45.261|< 0.0001
91634195|NCT00631969|183161312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.555|||<|0.0001||95.0|-43.645|-29.465|||ANCOVA|||Statistical analysis applies to the total population.||-29.465|-43.645|< 0.0001
91634196|NCT00631969|183161313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.193|||<|0.0001||95.0|-31.562|-18.824|||ANCOVA|||Statistical analysis applies to the total population.||-18.824|-31.562|< 0.0001
91634197|NCT00631969|183161315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.703|||<|0.0001||95.0|-30.067|-19.34|||ANCOVA|||Statistical analysis applies to the total population.||-19.340|-30.067|< 0.0001
91634198|NCT00631969|183161316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.496|||<|0.0001||95.0|-34.865|-24.128|||ANCOVA|||Statistical analysis applies to the total population.||-24.128|-34.865|< 0.0001
91634199|NCT00631969|183161317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.775|||<|0.0001||95.0|-33.155|-22.394|||ANCOVA|||Statistical analysis applies to the total population.||-22.394|-33.155|< 0.0001
91634200|NCT00631969|183161318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.326|||<|0.0001||95.0|-29.062|-17.598|||ANCOVA|||Statistical analysis applies to the total population.||-17.598|-29.062|< 0.0001
91634201|NCT00631969|183161319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.384|||<|0.0001||95.0|-28.594|-18.175|||ANCOVA|||Statistical analysis applies to the total population.||-18.175|-28.594|< 0.0001
91634202|NCT00631969|183161320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.076|||<|0.0001||95.0|-38.745|-27.407|||ANCOVA|||Statistical analysis applies to the total population.||-27.407|-38.745|< 0.0001
91634203|NCT00631969|183161321|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|74.449|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.||Statistical analysis applies to the total population.||||<0.0001
91484555|NCT02038452|182843114|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.009|TWO_SIDED|95.0|-1.72|-0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.24|-1.72|0.009
91484556|NCT02038452|182843115|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.058|TWO_SIDED|95.0|-0.02|1.54||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.54|-0.02|0.058
91484557|NCT02038452|182843116|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.95|TWO_SIDED|95.0|-0.79|0.85||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.85|-0.79|0.95
91484558|NCT02038452|182843117|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.35|TWO_SIDED|95.0|-0.45|1.26||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.26|-0.45|0.35
91634204|NCT00631969|183161322|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|117.42||||||90.0|79.59|173.23||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||173.23|79.59|
91634205|NCT00631969|183161322|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7064||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.7064
91634206|NCT00631969|183161323|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|133.07||||||90.0|87.46|202.46||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||202.46|87.46|
91634207|NCT00631969|183161323|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.8749||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.8749
91634208|NCT00631969|183161324|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|125.28||||||90.0|73.65|213.11||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \< 65 years) were calculated.||213.11|73.65|
91634209|NCT00631969|183161324|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7375||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.7375
91634210|NCT00631969|183161325|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|123.84||||||90.0|80.12|191.42||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||191.42|80.12|
91634211|NCT00631969|183161325|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.394||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.3940
91634212|NCT01084096|183161326|SUPERIORITY|Trial powered to detect a 30% reduction in 28-d NM among \<5th %tile for birth weight infants. We used an intention-to-treat approach, with a model-based adaptation of the permutation test. We fitted an individual-level linear model with 28-d NM by site and randomization strata, nested within site, and computed the residual for each individual and mean cluster-level residuals. Next, we used an ANOVA model to test for trt differences between mean residuals for intervention and control clusters.|Risk Ratio (RR)|0.96||||0.65|TWO_SIDED|95.0|0.87|1.06|||t-test, 2 sided|Cluster-level with 62 degrees of freedom \[101 clusters-37 strata-2 treatment groups\].|Calculated from generalized linear models accounting for the cluster-level variance and adjusted for randomization strata. Each stratum corresponds to 2-4 clusters within the site with equal distribution to treatment and control arms.|||1.06|0.87|0.65
91634213|NCT01084096|183161327|SUPERIORITY||Risk Difference (RD)|0.3546|||<|0.0001|TWO_SIDED|95.0|0.3299|0.3792|||Cochran-Mantel-Haenszel|P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Risk difference represents risk in the intervention clusters minus the risk in the control clusters.|The trial was powered to detect a 30% reduction in 28-day neonatal mortality among infants born at less than the 5th percentile of birth weight, based on previous research and an expected increase from 10% to 50% in the use of antenatal corticosteroids among women at risk of preterm birth in the intervention group.||0.3792|0.3299|<0.0001
91634214|NCT01084096|183161328|OTHER|Descriptive analysis.|Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.33|1.58||P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Cochran-Mantel-Haenszel|||||1.58|1.33|<0.0001
91692410|NCT03187301|183279689|NON_INFERIORITY|60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.5||||||||7.5|-0.9|
91667492|NCT01277510|183229025|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.0||||0.117|TWO_SIDED|95.0|-22.5|2.6|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||2.6|-22.5|0.117
91667493|NCT01277510|183229026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.896|TWO_SIDED|95.0|-3.1|3.6||No adjustments for multiplicity were made.|ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||3.6|-3.1|0.896
91667494|NCT01277510|183229028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8||||0.854|TWO_SIDED|95.0|-9.4|7.9|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||7.9|-9.4|0.854
91667495|NCT03555695|183229060|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
91667496|NCT01426854|183229071|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91667497|NCT02940522|183229134|OTHER|Comparison of bioavailability|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
91667498|NCT02940522|183229135|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
91667499|NCT02940522|183229136|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
91667500|NCT02940522|183229137|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
91667501|NCT02940522|183229138|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
91484559|NCT02038452|182843118|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.54|<0.001
91667502|NCT02940522|183229139|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
91667503|NCT00274625|183229140|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Fisher Exact|||||||0.60
91667504|NCT01680016|183229170|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years||1.02|0.69|
91667505|NCT01680016|183229171|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|1.09|||||TWO_SIDED|95.0|0.87|1.35|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years||1.35|0.87|
91667506|NCT03460990|183229190|SUPERIORITY||Least Squares (LS) Mean Difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.5|||Mixed-effects model for repeated measure|||||12.5|7.4|< 0.0001
91667507|NCT03460990|183229191|SUPERIORITY||LS Mean Difference|-48.7|||<|0.0001|TWO_SIDED|95.0|-53.9|-43.5|||Mixed-effects model for repeated measure|||||-43.5|-53.9|<0.0001
91667508|NCT03460990|183229192|SUPERIORITY||LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|8.8|18.3|||Mixed-effects model for repeated measure|||||18.3|8.8|<0.0001
91667509|NCT01958060|183229196|SUPERIORITY_OR_OTHER||Slope|1.0604|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|95.0|0.9901|1.1308|||||Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.||1.1308|0.9901|
91667510|NCT01958060|183229198|SUPERIORITY_OR_OTHER||Slope|1.5629|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|1.3426|1.7833|||||Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.||1.7833|1.3426|
91714418|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.8|STANDARD_ERROR_OF_MEAN|11.06||0.0161||95.0|-48.5|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-48.5|0.0161
91714419|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|10.67||0.8506||95.0|-23.0|19.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-23.0|0.8506
91714420|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.9|STANDARD_ERROR_OF_MEAN|11.31||0.0067||95.0|-53.2|-8.6|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-8.6|-53.2|0.0067
91714421|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|10.76||0.1997||95.0|-35.0|7.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-35.0|0.1997
91714422|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.4|STANDARD_ERROR_OF_MEAN|10.9||0.0159||95.0|-47.9|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-47.9|0.0159
91792551|NCT02129777|183462751|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.619||0.045|TWO_SIDED|95.0|-2.49|-0.03|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.03|-2.49|0.045
91484560|NCT02038452|182843119|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.59|-0.21|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.21|-0.59|<0.001
91484561|NCT02038452|182843120|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.005|TWO_SIDED|95.0|-0.44|-0.08|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.08|-0.44|0.005
91484562|NCT02038452|182843121|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.002|TWO_SIDED|95.0|-1.72|-0.38|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.38|-1.72|0.002
91714423|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|10.98||0.0388||95.0|-44.4|-1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.2|-44.4|0.0388
91484563|NCT02038452|182843122|SUPERIORITY||Odds Ratio (OR)|0.35||||0.006|TWO_SIDED|95.0|0.17|0.74|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.17|0.006
91484564|NCT02038452|182843123|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.58|TWO_SIDED|95.0|-0.13|0.24|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.24|-0.13|0.58
91634215|NCT01084096|183161330|SUPERIORITY||Risk Ratio (RR)|1.12||||0.0127|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0127
91634216|NCT01084096|183161331|OTHER|Descriptive analysis.|Risk Ratio (RR)|1.11||||0.0181|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0181
91634217|NCT01451203|183161369|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann point estimate of shift|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.|ANCOVA|||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 52.The primary Week 52 analysis assessed whether treatment up to Week 52 with the CZP group was superior to the placebo group in mTSS at Week 52. The 2-sided null and alternative hypotheses were: H0: πC = πM Ha: πC ≠ πM where πC represented subjects in the CZP group at Week 52 and πM represented subjects in the placebo group at Week 52.||0.00|0.00|<0.001
91714424|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|10.73||0.9962||95.0|-21.2|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-21.2|0.9962
91714425|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.8|STANDARD_ERROR_OF_MEAN|11.41||0.0839||95.0|-42.3|2.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.7|-42.3|0.0839
91634218|NCT01451203|183161370|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman point estimate of shift|0.0||||0.003|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 24.||0.00|0.00|0.003
91634219|NCT01451203|183161371|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91634220|NCT01451203|183161372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91634221|NCT01451203|183161373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Fisher Exact|||||||0.002
91634222|NCT01249404|183161379|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-0.1|||=|0.2859|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.1|-0.3|=0.2859
91634223|NCT01249404|183161379|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|||=|0.0091|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||-0.1|-0.5|=0.0091
91634224|NCT01249404|183161380|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.064|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0640
91634225|NCT01249404|183161380|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.0665|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0665
91634226|NCT01249404|183161380|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0466|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0466
91634227|NCT01249404|183161380|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0406|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0406
91634228|NCT01249404|183161381|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|||=|0.7247|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.03|-0.02|=0.7247
91634229|NCT01249404|183161381|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|||=|0.7266|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.02|-0.03|=0.7266
91484565|NCT02038452|182843124|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.25|TWO_SIDED|95.0|-0.09|0.35|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.09|0.25
91634230|NCT04495166|183161427|SUPERIORITY|||||||0.757||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.||||0.757
91484566|NCT02038452|182843125|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.93|TWO_SIDED|95.0|-0.17|0.18|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.18|-0.17|0.93
91484567|NCT02038452|182843126|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.052|TWO_SIDED|95.0|-0.01|1.61|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.61|-0.01|0.052
91484568|NCT02038452|182843127|SUPERIORITY||Odds Ratio (OR)|1.29||||0.53|TWO_SIDED|95.0|0.58|2.88|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.88|0.58|0.53
91634231|NCT04495166|183161428|SUPERIORITY|||||||0.91||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.910
91634232|NCT04495166|183161430|SUPERIORITY|||||||0.442||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.442
91634233|NCT04495166|183161431|SUPERIORITY|||||||0.223||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.223
91634234|NCT04495166|183161432|SUPERIORITY|||||||0.54||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.540
91634235|NCT04495166|183161433|SUPERIORITY|||||||0.901||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.901
91634236|NCT04495166|183161434|SUPERIORITY|||||||0.748||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.748
91634237|NCT01716585|183161444|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.|Percentage of Participants with SVR12|96.4|||||TWO_SIDED|95.0|94.7|98.1|||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.||98.1|94.7|
91634238|NCT01716585|183161445|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|Fisher Exact|||||||< 0.001
91634239|NCT01716585|183161446|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|95.7|||||TWO_SIDED|95.0|93.4|97.9||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|||95% CI calculated using the normal approximation to the binomial distribution.|||97.9|93.4|
91634240|NCT01716585|183161447|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|98.0|||||TWO_SIDED|95.0|95.8|100.0|||||95% CI calculated using the normal approximation to the binomial distribution.|||100.0|95.8|
91484569|NCT02038452|182843128|SUPERIORITY||Odds Ratio (OR)|1.43||||0.41|TWO_SIDED|95.0|0.61|3.34|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.34|0.61|0.41
91484570|NCT02038452|182843130|SUPERIORITY||Odds Ratio (OR)|1.32||||0.52|TWO_SIDED|95.0|0.57|3.06|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.06|0.57|0.52
91484571|NCT02038452|182843131|SUPERIORITY||Odds Ratio (OR)|2.05||||0.18|TWO_SIDED|95.0|0.72|5.78|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||5.78|0.72|0.18
91634241|NCT00125138|183161455|SUPERIORITY_OR_OTHER||Difference of LS Mean|0.1||||0.5177|TWO_SIDED|95.0|-6.3|6.6||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||6.6|-6.3|0.5177
91634242|NCT00125138|183161455|SUPERIORITY_OR_OTHER||Difference of LS mean|-2.9||||0.1519|TWO_SIDED|95.0|-8.5|2.7||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||2.7|-8.5|0.1519
91634243|NCT00125138|183161455|SUPERIORITY_OR_OTHER||Difference of LS mean|0.3||||0.5406|TWO_SIDED|95.0|-5.2|5.8||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||5.8|-5.2|0.5406
91634244|NCT00125138|183161456|SUPERIORITY_OR_OTHER|||||||0.9212||95.0||||Overall p-value using a one-way ANCOVA.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||Only subjects with both a baseline and a post-baseline value are included.||||0.9212
91634245|NCT00041119|183161457|SUPERIORITY|If the 5-year DFS for 4 cycles is 84.7% then a decrease of 23% in hazard rate for 6 cycles corresponds to an increase in 5-year DFS to 88%. Assuming a 2-sided significance level of 0.05, there is 90.9% power to detect such an increase at the final analysis conducted 6.4 years after study activation.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||The null hypothesis is that the hazards of both 6 and 4 cycle regimens are equal. The alternative hypothesis is a hazard ratio of 0.77, corresponding to a decrease of 23% in hazard due to longer duration of chemotherapy.||1.28|0.84|
91634246|NCT00041119|183161458|EQUIVALENCE|For T to be considered equivalent to the standard CA, a confidence interval of the hazard ratio of T to CA should be wholly to the left of 1.3, corresponding to a 30% increase in hazard rate. If the 5-year DFS for CA is 88% then an increase of 30% in hazard rate for T corresponds to 5-year DFS of 84.7%. The null hypothesis is that the hazard ratio of T to CA exceeds 1.3. The alternative hypothesis is that the two hazard rates are equivalent.|Hazard Ratio (HR)|1.26|||||ONE_SIDED|95.0||1.48||||||||1.48||
91634247|NCT00041119|183161459|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years. We assume the 5-year DFS of CA therapy is 88% and 84.7% for T. These assumptions are based upon results of SWOG 8897.|Hazard Ratio (HR)|1.27|||||ONE_SIDED|95.0||1.56||||||||1.56||
91634248|NCT00041119|183161463|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.84|1.49||||||||1.49|.84|
91667511|NCT00377572|183229199|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Maximum Symptom Day Comparison||||<0.001
91667512|NCT00377572|183229200|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||0.04
91667513|NCT00377572|183229201|SUPERIORITY_OR_OTHER|||||||0.1111||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept (to account for within-subject correlation) and visit and group as fixed effects.||||||0.1111
91634249|NCT01258738|183161472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.64||||0.0062|TWO_SIDED|95.0|5.36|27.92||P-value \<0.05 was required to declare statistical significance.|Cochran-Mantel-Haenszel|||"The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo.~The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only."||27.92|5.36|0.0062
91667514|NCT00377572|183229202|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Childhood Asthma Control Test comparison||||0.007
91667515|NCT00377572|183229203|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Asthma Control Test comparison||||0.54
91667516|NCT00377572|183229204|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1 % of predicted value comparison||||0.30
91484572|NCT02038452|182843132|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.18|-0.55|<0.001
91634250|NCT01258738|183161473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.0059|TWO_SIDED|95.0|3.69|19.24|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.24|3.69|0.0059
91634251|NCT01258738|183161473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19||||0.3786|TWO_SIDED|95.0|-4.98|15.35|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4"||15.35|-4.98|0.3786
91634252|NCT01258738|183161473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0304|TWO_SIDED|95.0|1.79|23.87|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.87|1.79|0.0304
91634253|NCT01258738|183161473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.52||||0.0023|TWO_SIDED|95.0|7.29|29.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.75|7.29|0.0023
91634254|NCT01258738|183161474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.44||||0.0189|TWO_SIDED|95.0|3.2|25.68|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||25.68|3.20|0.0189
91634255|NCT01258738|183161474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29||||0.0983|TWO_SIDED|95.0|-2.17|22.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||22.75|-2.17|0.0983
91634256|NCT01258738|183161474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.61||||0.0867|TWO_SIDED|95.0|-2.63|23.84|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.84|-2.63|0.0867
91634257|NCT01258738|183161474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.27||||0.0195|TWO_SIDED|95.0|3.1|29.43|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.43|3.10|0.0195
91634258|NCT01258738|183161475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.63|||<|0.0001|TWO_SIDED|95.0|11.85|33.41|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||33.41|11.85|<0.0001
91634259|NCT01258738|183161475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0021|TWO_SIDED|95.0|5.09|20.57|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||20.57|5.09|0.0021
91667517|NCT00377572|183229205|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1:FVC ×100 comparison||||0.81
91634260|NCT01258738|183161475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.89||||0.002|TWO_SIDED|95.0|5.18|24.6|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||24.60|5.18|0.0020
91714426|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|10.83||0.5216||95.0|-28.3|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-28.3|0.5216
91634261|NCT01258738|183161475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.79|||<|0.0001|TWO_SIDED|95.0|10.92|32.67|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||32.67|10.92|<0.0001
91634262|NCT01258738|183161476|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634263|NCT01258738|183161476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.34|-0.74|<0.001
91667518|NCT00377572|183229206|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||<0.0001
91667519|NCT00377572|183229207|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Percent Adherence Comparison||||0.12
91634264|NCT01258738|183161476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.41|-0.81|<0.001
91634265|NCT01258738|183161476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-0.85|<0.001
91634266|NCT01258738|183161477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84||||0.0209|TWO_SIDED|95.0|2.58|23.09|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||23.09|2.58|0.0209
91634267|NCT01258738|183161477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.65||||0.0179|TWO_SIDED|95.0|1.82|15.48|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.~Week 2"||15.48|1.82|0.0179
91634268|NCT01258738|183161477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81||||0.0611|TWO_SIDED|95.0|-0.03|13.65|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||13.65|-0.03|0.0611
91634269|NCT01258738|183161477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73||||0.0141|TWO_SIDED|95.0|3.14|22.32|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||22.32|3.14|0.0141
91634270|NCT01258738|183161477|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91667520|NCT00377572|183229208|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 1- 2 (mild asthma) Percent Comparison||||0.001
91667521|NCT00377572|183229209|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 4 - 6 (severe asthma)percent comparison||||<0.001
91667522|NCT00377572|183229210|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Inhaled glucocorticoids prescribed - mcg per day comparison||||<0.001
91667523|NCT00377572|183229211|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Comparison percent prescribed long-acting beta 2 agonists||||0.003
91667524|NCT00377572|183229212|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|Hospitalizations were summed over the course of the double-blind \& analyzed with logistic regression (LR) of 'any' vs. 'none'. The LR was unadjusted.||||||0.02
91667525|NCT00377572|183229213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|Exacerbations were summed over the course of the double-blind and analyzed with an LR of 'any' versus 'none'. LR adjusted for study site and dosing.||||||<0.001
91667526|NCT00377572|183229214|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
91667527|NCT00377572|183229215|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.58
91634271|NCT01258738|183161478|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||||0.0022
91667528|NCT00769314|183229216|SUPERIORITY_OR_OTHER||Treatment difference|0.0685||||0.0419|TWO_SIDED|95.0|0.0025|0.1339||p-value \< 0.05 considered significant|Chi-squared||Treatment difference was the proportion of patients with aborted lesions in the acyclovir Lauriad group minus the proportion of patients with aborted lesions in the placebo group.|||0.1339|0.0025|0.0419
91667529|NCT00769314|183229217|SUPERIORITY_OR_OTHER|||||||0.0683||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0683
91667530|NCT00769314|183229218|SUPERIORITY_OR_OTHER|||||||0.0033||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0033
91667531|NCT00769314|183229219|SUPERIORITY_OR_OTHER|||||||0.0098||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0098
91667532|NCT00769314|183229220|SUPERIORITY_OR_OTHER|||||||0.8005||||||p-value \< 0.05 considered significant|Log Rank|||||||0.8005
91667533|NCT00769314|183229221|SUPERIORITY_OR_OTHER|||||||0.015||||||p-value \< 0.05 considered significant|Log Rank|||||||0.015
91667534|NCT00769314|183229222|SUPERIORITY_OR_OTHER|||||||0.0412||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0412
91667535|NCT00769314|183229223|SUPERIORITY_OR_OTHER|||||||0.0271||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0271
91667536|NCT00769314|183229224|SUPERIORITY_OR_OTHER|||||||0.5695||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 1 timepoint.||||0.5695
91667537|NCT00769314|183229224|SUPERIORITY_OR_OTHER|||||||0.1824||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 3 timepoint||||0.1824
91667538|NCT00769314|183229224|SUPERIORITY_OR_OTHER|||||||0.0078||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 5 timepoint||||0.0078
91667539|NCT00769314|183229224|SUPERIORITY_OR_OTHER|||||||0.3303||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 7 timepoint||||0.3303
91667540|NCT00769314|183229224|SUPERIORITY_OR_OTHER|||||||0.6045||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 14 timepoint||||0.6045
91792552|NCT02129777|183462751|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.62||0.118|TWO_SIDED|95.0|-2.21|0.25|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.25|-2.21|0.118
91634272|NCT01258738|183161479|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634273|NCT01258738|183161479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0156|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.13|-1.26|0.0156
91634274|NCT01258738|183161479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0111|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.14|-1.06|0.0111
91634275|NCT01258738|183161479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0936|TWO_SIDED|95.0|-0.91|0.07|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.07|-0.91|0.0936
91634276|NCT01258738|183161479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2678|TWO_SIDED|95.0|-0.81|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.23|-0.81|0.2678
91634277|NCT01258738|183161480|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634278|NCT01258738|183161480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0102|TWO_SIDED|95.0|-1.4|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.40|0.0102
91634279|NCT01258738|183161480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0007|TWO_SIDED|95.0|-1.44|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.39|-1.44|0.0007
91634280|NCT01258738|183161480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0057|TWO_SIDED|95.0|-1.35|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.23|-1.35|0.0057
91634281|NCT01258738|183161480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0077|TWO_SIDED|95.0|-1.44|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.44|0.0077
91634282|NCT01258738|183161481|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634283|NCT01258738|183161481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0091|TWO_SIDED|95.0|-1.62|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.23|-1.62|0.0091
91634284|NCT01258738|183161481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0097|TWO_SIDED|95.0|-1.38|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.19|-1.38|0.0097
91634285|NCT01258738|183161481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0101|TWO_SIDED|95.0|-1.45|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.45|0.0101
91634286|NCT01258738|183161481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0031|TWO_SIDED|95.0|-1.61|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.33|-1.61|0.0031
91634287|NCT01258738|183161482|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634288|NCT01258738|183161482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.0064|TWO_SIDED|95.0|-1.49|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.25|-1.49|0.0064
91634289|NCT01258738|183161482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0407|TWO_SIDED|95.0|-1.12|-0.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.02|-1.12|0.0407
91634290|NCT01258738|183161482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0349|TWO_SIDED|95.0|-1.24|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.24|0.0349
91667541|NCT00769314|183229225|SUPERIORITY_OR_OTHER|||||||0.0022||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0022
91634291|NCT01258738|183161482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0021|TWO_SIDED|95.0|-1.65|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-1.65|0.0021
91634292|NCT01258738|183161483|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634293|NCT01258738|183161483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0164|TWO_SIDED|95.0|-1.04|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.04|0.0164
91634294|NCT01258738|183161483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0095|TWO_SIDED|95.0|-0.95|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-0.95|0.0095
91634295|NCT01258738|183161483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0127|TWO_SIDED|95.0|-0.99|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.12|-0.99|0.0127
91634296|NCT01258738|183161483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0166|TWO_SIDED|95.0|-0.99|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-0.99|0.0166
91634297|NCT01258738|183161484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634298|NCT01258738|183161484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0029|TWO_SIDED|95.0|-1.28|-0.27|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.27|-1.28|0.0029
91634299|NCT01258738|183161484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0147|TWO_SIDED|95.0|-1.21|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.13|-1.21|0.0147
91634300|NCT01258738|183161484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0056|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.28|0.0056
91634301|NCT01258738|183161484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.001|TWO_SIDED|95.0|-1.52|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.39|-1.52|0.0010
91634302|NCT01258738|183161485|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634303|NCT01258738|183161485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0173|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.12|-1.19|0.0173
91692411|NCT03187301|183279689|NON_INFERIORITY|2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.8|9.2||||||||9.2|0.8|
91634304|NCT01258738|183161485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1618|TWO_SIDED|95.0|-0.97|0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.16|-0.97|0.1618
91634305|NCT01258738|183161485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0153|TWO_SIDED|95.0|-1.25|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.13|-1.25|0.0153
91634306|NCT01258738|183161485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0866|TWO_SIDED|95.0|-1.05|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.07|-1.05|0.0866
91634307|NCT01258738|183161486|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91692412|NCT03187301|183279689|NON_INFERIORITY|3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|0.4|8.8||||||||8.8|0.4|
91714427|NCT00676403|183320245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.3|STANDARD_ERROR_OF_MEAN|10.98||0.0534||95.0|-42.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-42.9|0.0534
91714428|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|5.89||0.0199||95.0|2.2|25.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.4|2.2|0.0199
91714429|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|5.78||0.0768||95.0|-1.1|21.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.7|-1.1|0.0768
91714430|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.91||0.0642||95.0|-0.7|22.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.6|-0.7|0.0642
91714431|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|5.88||0.2643||95.0|-5.0|18.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.2|-5.0|0.2643
91714432|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.2|STANDARD_ERROR_OF_MEAN|5.8||0.0358||95.0|0.8|23.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.7|0.8|0.0358
91484573|NCT02038452|182843133|SUPERIORITY||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.59|<0.001
91634308|NCT01258738|183161486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.1413|TWO_SIDED|95.0|-0.95|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.95|0.1413
91634309|NCT01258738|183161486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0284|TWO_SIDED|95.0|-1.14|-0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.06|-1.14|0.0284
91714433|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.93||0.0428||95.0|0.4|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.4|0.0428
91714434|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|5.81||0.1993||95.0|-4.0|18.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.9|-4.0|0.1993
91792553|NCT02129777|183462751|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.616||0.05|TWO_SIDED|95.0|-2.44|0.0|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.00|-2.44|0.050
91484574|NCT02038452|182843134|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.003|TWO_SIDED|95.0|-0.46|-0.09|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.09|-0.46|0.003
91634310|NCT01258738|183161486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0659|TWO_SIDED|95.0|-1.07|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.03|-1.07|0.0659
91634311|NCT01258738|183161486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0098|TWO_SIDED|95.0|-1.26|-0.18|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.18|-1.26|0.0098
91484575|NCT02038452|182843135|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.001|TWO_SIDED|95.0|-1.85|-0.48|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.48|-1.85|0.001
91667542|NCT02846883|183229235|SUPERIORITY|These power estimates are based on linear regression of regulatory T-cell counts at each time point. These data will be summarized with the mean, median, standard deviation, standard error, minimum and maximum.|Mean Difference (Final Values)|81.0|||<|0.05|TWO_SIDED|95.0||||P value is adjusted for multiple comparisons|Regression, Cox|See above|Estimates for the differences in the secondary endpoints will be used to perform a power estimation using a Monte Carlo simulation method.|The primary statistical evaluation for Aim 1 will focus on the chronologically increasing counts of T-regulatory cells over time following MSC administration in both delivery groups. Using the pattern of increased counts with time and the standard deviation reported by Ito and colleagues in healthy subjects, 36 subjects provides 81.0% power to detect such a change.A p value of \<0.05 will be considered significant.||||<0.05
91667543|NCT00500318|183229267|SUPERIORITY_OR_OTHER||Least Square Mean|116.44|STANDARD_ERROR_OF_MEAN|40.113||0.0042|TWO_SIDED|95.0|37.28|195.61|||ANCOVA|||||195.610|37.280|0.0042
91667544|NCT02435433|183229276|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0199|TWO_SIDED|95.0|0.531|0.949|||Log Rank||Stratified analysis|||0.949|0.531|0.0199
91667545|NCT02435433|183229277|SUPERIORITY||Hazard Ratio (HR)|0.452|||<|0.0001|TWO_SIDED|95.0|0.339|0.603|||Log Rank||Stratified analysis|||0.603|0.339|<0.0001
91667546|NCT02435433|183229278|SUPERIORITY||Hazard Ratio (HR)|0.427|||<|0.0001|TWO_SIDED|95.0|0.313|0.582|||Log Rank||Stratified analysis|||0.582|0.313|<0.0001
91667547|NCT02435433|183229279|SUPERIORITY||Odds Ratio (OR)|4.6||||0.1697|TWO_SIDED|95.0|0.6|37.3|||Cochran-Mantel-Haenszel||Stratified analysis|||37.3|0.6|0.1697
91667548|NCT02435433|183229283|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.2382|TWO_SIDED|95.0|0.545|1.171|||Log Rank||Stratified analysis|||1.171|0.545|0.2382
91667549|NCT01243151|183229300|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.68|STANDARD_ERROR_OF_MEAN|8.323|<|0.0001|TWO_SIDED|95.0|-71.37|-37.99|||ANCOVA|||Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.99|-71.37|<0.0001
91667550|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|8.53|<|0.0001|TWO_SIDED|95.0|-61.28|-27.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.08|-61.28|<0.0001
91714435|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|STANDARD_ERROR_OF_MEAN|6.04||0.0331||95.0|1.1|24.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.8|1.1|0.0331
91714436|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.91||0.0415||95.0|0.5|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.5|0.0415
91484576|NCT02038452|182843136|SUPERIORITY||Odds Ratio (OR)|0.34||||0.007|TWO_SIDED|95.0|0.16|0.74|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.16|0.007
91714437|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.8|STANDARD_ERROR_OF_MEAN|5.83||0.0295||95.0|1.3|24.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.3|1.3|0.0295
91667551|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.44|STANDARD_ERROR_OF_MEAN|8.433|<|0.0001|TWO_SIDED|95.0|-81.35|-47.53|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.53|-81.35|<0.0001
91667552|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.75|STANDARD_ERROR_OF_MEAN|8.282|<|0.0001|TWO_SIDED|95.0|-78.36|-45.15|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.15|-78.36|<0.0001
91667553|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-72.16|STANDARD_ERROR_OF_MEAN|10.097|<|0.0001|TWO_SIDED|95.0|-92.4|-51.92|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-51.92|-92.40|<0.0001
91667554|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.89|STANDARD_ERROR_OF_MEAN|10.328|<|0.0001|TWO_SIDED|95.0|-84.59|-43.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.19|-84.59|<0.0001
91667555|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-88.69|STANDARD_ERROR_OF_MEAN|10.327|<|0.0001|TWO_SIDED|95.0|-109.39|-68.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-68.00|-109.39|<0.0001
91667556|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.65|STANDARD_ERROR_OF_MEAN|10.028|<|0.0001|TWO_SIDED|95.0|-104.76|-64.54|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-64.54|-104.76|<0.0001
91634312|NCT01258738|183161487|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634313|NCT01258738|183161487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0037|TWO_SIDED|95.0|-1.26|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.25|-1.26|0.0037
91634314|NCT01258738|183161487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0044|TWO_SIDED|95.0|-1.35|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.25|-1.35|0.0044
91634315|NCT01258738|183161487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0104|TWO_SIDED|95.0|-1.26|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.17|-1.26|0.0104
91634316|NCT01258738|183161487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.006|TWO_SIDED|95.0|-1.33|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.22|-1.33|0.0060
91634317|NCT01258738|183161488|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634318|NCT01258738|183161488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2268|TWO_SIDED|95.0|-0.8|0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.19|-0.80|0.2268
91634319|NCT01258738|183161488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1145|TWO_SIDED|95.0|-0.93|0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.10|-0.93|0.1145
91634320|NCT01258738|183161488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0512|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.00|-1.00|0.0512
91634321|NCT01258738|183161488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0509|TWO_SIDED|95.0|-1.02|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.00|-1.02|0.0509
91634322|NCT01258738|183161489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634323|NCT01258738|183161489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.243|TWO_SIDED|95.0|-0.79|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.20|-0.79|0.2430
91634324|NCT01258738|183161489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0384|TWO_SIDED|95.0|-1.09|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.09|0.0384
91634325|NCT01258738|183161489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0797|TWO_SIDED|95.0|-1.03|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.06|-1.03|0.0797
91634326|NCT01258738|183161489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.2186|TWO_SIDED|95.0|-0.9|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.21|-0.90|0.2186
91634327|NCT01258738|183161490|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634328|NCT01258738|183161490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.141|TWO_SIDED|95.0|-0.96|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.96|0.1410
91634329|NCT01258738|183161490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2299|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.21|-0.88|0.2299
91634330|NCT01258738|183161490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.3221|TWO_SIDED|95.0|-0.87|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.29|-0.87|0.3221
91634331|NCT01258738|183161490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1891|TWO_SIDED|95.0|-0.99|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.20|-0.99|0.1891
91634332|NCT01258738|183161491|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91667557|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|8.854|<|0.0001|TWO_SIDED|95.0|-96.22|-60.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.71|-96.22|<0.0001
91667558|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.45|STANDARD_ERROR_OF_MEAN|8.998|<|0.0001|TWO_SIDED|95.0|-102.51|-66.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.40|-102.51|<0.0001
91792554|NCT02129777|183462752|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.503||0.211|TWO_SIDED|95.0|-1.63|0.36|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.36|-1.63|0.211
91484577|NCT02038452|182843137|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.63|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.25|-0.15|0.63
91634333|NCT01258738|183161491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.108|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.09|-0.90|0.1080
91634334|NCT01258738|183161491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0389|TWO_SIDED|95.0|-1.06|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.06|0.0389
91634335|NCT01258738|183161491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.1181|TWO_SIDED|95.0|-0.98|0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.11|-0.98|0.1181
91634336|NCT01258738|183161491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.2271|TWO_SIDED|95.0|-0.94|0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.22|-0.94|0.2271
91634337|NCT01258738|183161492|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634338|NCT01258738|183161492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0044|TWO_SIDED|95.0|-1.27|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.27|0.0044
91634339|NCT01258738|183161492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0455|TWO_SIDED|95.0|-1.09|-0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.01|-1.09|0.0455
91634340|NCT01258738|183161492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.175|TWO_SIDED|95.0|-0.91|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.17|-0.91|0.1750
91634341|NCT01258738|183161492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0379|TWO_SIDED|95.0|-1.12|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.03|-1.12|0.0379
91634342|NCT01258738|183161493|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634343|NCT01258738|183161493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0826|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.06|-0.98|0.0826
91634344|NCT01258738|183161493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1538|TWO_SIDED|95.0|-0.96|0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.15|-0.96|0.1538
91634345|NCT01258738|183161493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0728|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.05|-1.04|0.0728
91634346|NCT01258738|183161493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0975|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.08|-0.99|0.0975
91634347|NCT01258738|183161494|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91667559|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-96.08|STANDARD_ERROR_OF_MEAN|8.994|<|0.0001|TWO_SIDED|95.0|-114.12|-78.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-78.03|-114.12|<0.0001
91667560|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.33|STANDARD_ERROR_OF_MEAN|8.703|<|0.0001|TWO_SIDED|95.0|-109.8|-74.86|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.86|-109.80|<0.0001
91667561|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.41|STANDARD_ERROR_OF_MEAN|9.534|<|0.0001|TWO_SIDED|95.0|-90.51|-52.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.30|-90.51|<0.0001
91667562|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.01|STANDARD_ERROR_OF_MEAN|9.659|<|0.0001|TWO_SIDED|95.0|-95.37|-56.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.65|-95.37|<0.0001
91667563|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.78|STANDARD_ERROR_OF_MEAN|9.678|<|0.0001|TWO_SIDED|95.0|-113.18|-74.38|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.38|-113.18|<0.0001
91667564|NCT01243151|183229300|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.58|STANDARD_ERROR_OF_MEAN|9.362|<|0.0001|TWO_SIDED|95.0|-108.35|-70.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-70.81|-108.35|<0.0001
91714438|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|6.01||0.1267||95.0|-2.6|21.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.6|0.1267
91714439|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|5.84||0.4175||95.0|-6.8|16.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.2|-6.8|0.4175
91484578|NCT02038452|182843138|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.28|TWO_SIDED|95.0|-0.1|0.35|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.10|0.28
91484579|NCT02038452|182843139|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9|TWO_SIDED|95.0|-0.18|0.2|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.20|-0.18|0.900
91484580|NCT02038452|182843140|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.09|TWO_SIDED|95.0|-0.11|1.59|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.59|-0.11|0.09
91667565|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.82|STANDARD_ERROR_OF_MEAN|5.077|<|0.0001|TWO_SIDED|95.0|-43.99|-23.65|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.65|-43.99|<0.0001
91714440|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|6.09||0.0342||95.0|1.0|25.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.0|1.0|0.0342
91484581|NCT02038452|182843141|SUPERIORITY||Odds Ratio (OR)|1.26||||0.58|TWO_SIDED|95.0|0.56|2.85|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.85|0.56|0.58
91484582|NCT02038452|182843142|SUPERIORITY||Odds Ratio (OR)|1.31||||0.52|TWO_SIDED|95.0|0.57|3.01|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.01|0.57|0.52
91484583|NCT02038452|182843144|SUPERIORITY||Odds Ratio (OR)|1.25||||0.61|TWO_SIDED|95.0|0.53|2.95|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||2.95|0.53|0.61
91667566|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.93|STANDARD_ERROR_OF_MEAN|5.202|<|0.0001|TWO_SIDED|95.0|-38.35|-17.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.51|-38.35|<0.0001
91484584|NCT02038452|182843145|SUPERIORITY||Odds Ratio (OR)|2.24||||0.14|TWO_SIDED|95.0|0.77|6.58|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||6.58|0.77|0.14
91484585|NCT02038452|182843146|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.014|TWO_SIDED|95.0|-0.93|-0.12|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.12|-0.93|0.014
91484586|NCT02038452|182843147|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.53|TWO_SIDED|95.0|-0.5|0.26|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.26|-0.50|0.53
91634348|NCT01258738|183161494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0186|TWO_SIDED|95.0|-1.18|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.18|0.0186
91634349|NCT01258738|183161494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0106|TWO_SIDED|95.0|-1.01|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-1.01|0.0106
91634350|NCT01258738|183161494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0048|TWO_SIDED|95.0|-1.11|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.11|0.0048
91667567|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.59|STANDARD_ERROR_OF_MEAN|5.143|<|0.0001|TWO_SIDED|95.0|-49.89|-29.28|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.28|-49.89|<0.0001
91667568|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.63|STANDARD_ERROR_OF_MEAN|5.051|<|0.0001|TWO_SIDED|95.0|-47.75|-27.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.51|-47.75|<0.0001
91667569|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.99|STANDARD_ERROR_OF_MEAN|6.384|<|0.0001|TWO_SIDED|95.0|-58.78|-33.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-33.20|-58.78|<0.0001
91667570|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.82|STANDARD_ERROR_OF_MEAN|6.527|<|0.0001|TWO_SIDED|95.0|-54.9|-28.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.74|-54.90|<0.0001
91634351|NCT01258738|183161494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0016|TWO_SIDED|95.0|-1.31|-0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.31|-1.31|0.0016
91634352|NCT01258738|183161495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634353|NCT01258738|183161495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0058|TWO_SIDED|95.0|-1.37|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.37|0.0058
91634354|NCT01258738|183161495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0064|TWO_SIDED|95.0|-1.42|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.24|-1.42|0.0064
91634355|NCT01258738|183161495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.0002|TWO_SIDED|95.0|-1.85|-0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.60|-1.85|0.0002
91667571|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.35|STANDARD_ERROR_OF_MEAN|6.531|<|0.0001|TWO_SIDED|95.0|-69.43|-43.27|||ANCOVA|||Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.27|-69.43|<0.0001
91714441|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.96||0.1038||95.0|-2.0|21.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.5|-2.0|0.1038
91634356|NCT01258738|183161495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0134|TWO_SIDED|95.0|-1.49|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.17|-1.49|0.0134
91634357|NCT01258738|183161496|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634358|NCT01258738|183161496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0316|TWO_SIDED|95.0|-1.09|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.05|-1.09|0.0316
91634359|NCT01258738|183161496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0973|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-0.99|0.0973
91667572|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.45|STANDARD_ERROR_OF_MEAN|6.344|<|0.0001|TWO_SIDED|95.0|-66.17|-40.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.74|-66.17|<0.0001
91667573|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.67|STANDARD_ERROR_OF_MEAN|5.498|<|0.0001|TWO_SIDED|95.0|-60.7|-38.64|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.64|-60.70|<0.0001
91667574|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.92|STANDARD_ERROR_OF_MEAN|5.592|<|0.0001|TWO_SIDED|95.0|-65.14|-42.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-42.70|-65.14|<0.0001
91667575|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.6|STANDARD_ERROR_OF_MEAN|5.59|<|0.0001|TWO_SIDED|95.0|-71.81|-49.38|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.38|-71.81|<0.0001
91484587|NCT02038452|182843148|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.015|TWO_SIDED|95.0|-0.44|-0.05|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.05|-0.44|0.015
91484588|NCT02038452|182843149|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-0.97|-0.23|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.23|-0.97|0.002
91667576|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.67|STANDARD_ERROR_OF_MEAN|5.413|<|0.0001|TWO_SIDED|95.0|-68.53|-46.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.80|-68.53|<0.0001
91667577|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-55.8|-32.57|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.57|-55.80|<0.0001
91667578|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.28|STANDARD_ERROR_OF_MEAN|5.881|<|0.0001|TWO_SIDED|95.0|-59.06|-35.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.50|-59.06|<0.0001
91667579|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.73|STANDARD_ERROR_OF_MEAN|5.891|<|0.0001|TWO_SIDED|95.0|-69.53|-45.94|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.94|-69.53|<0.0001
91667580|NCT01243151|183229301|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.96|STANDARD_ERROR_OF_MEAN|5.701|<|0.0001|TWO_SIDED|95.0|-66.38|-43.54|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.54|-66.38|<0.0001
91667581|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.972||||0.0472|TWO_SIDED|95.0|1.04|599.65|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||599.65|1.04|0.0472
91667582|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.815||||0.1368|TWO_SIDED|95.0|0.46|305.54|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||305.54|0.46|0.1368
91667583|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.527||||0.019|TWO_SIDED|95.0|1.89|1198.29|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1198.29|1.89|0.0190
91484589|NCT02038452|182843150|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.25|TWO_SIDED|95.0|-0.6|0.16|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.16|-0.60|0.25
91484590|NCT02038452|182843151|SUPERIORITY||Mean Difference (Final Values)|33.54|||||TWO_SIDED|95.0|-94.57|145.59|||Regression, Linear|Comparison of outcome between treatment groups performed on multiply imputed data||||145.59|-94.57|
91667584|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.328||||0.0192|TWO_SIDED|95.0|1.86|1103.73|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1103.73|1.86|0.0192
91667585|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.273||||0.0105|TWO_SIDED|95.0|2.74|2014.67|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2014.67|2.74|0.0105
91667586|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.088||||0.0086|TWO_SIDED|95.0|3.1|2389.27|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2389.27|3.10|0.0086
91667587|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|87.733||||0.0084|TWO_SIDED|95.0|3.14|2449.11|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2449.11|3.14|0.0084
91667588|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.272||||0.0053|TWO_SIDED|95.0|4.07|3097.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3097.22|4.07|0.0053
91484591|NCT02038452|182843152|SUPERIORITY||Mean Difference (Final Values)|47.06|||||TWO_SIDED|95.0|-104.84|187.31|||Regression, Linear|Comparison of outcome between treatment groups on complete data.||||187.31|-104.84|
91484592|NCT02038452|182843153|SUPERIORITY||Mean Difference (Final Values)|113.15|||||TWO_SIDED|95.0|-37.09|279.21|||Regression, Linear|Comparison of outcome between treatment groups||||279.21|-37.09|
91484593|NCT02038452|182843154|SUPERIORITY||Mean Difference (Final Values)|71.1|||||TWO_SIDED|95.0|-120.84|291.24|||Regression, Linear|Comparison of outcome between treatment groups||||291.24|-120.84|
91484594|NCT02038452|182843155|SUPERIORITY||Mean Difference (Final Values)|0.008|||||TWO_SIDED|95.0|-0.01|0.02|||Regression, Linear|||||0.02|-0.01|
91634360|NCT01258738|183161496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0216|TWO_SIDED|95.0|-1.27|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-1.27|0.0216
91634361|NCT01258738|183161496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.2425|TWO_SIDED|95.0|-1.03|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.03|0.2425
91634362|NCT01258738|183161497|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634363|NCT01258738|183161497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2688|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.26|-0.92|0.2688
91634364|NCT01258738|183161497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0866|TWO_SIDED|95.0|-1.17|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-1.17|0.0866
91634365|NCT01258738|183161497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0277|TWO_SIDED|95.0|-1.34|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.08|-1.34|0.0277
91634366|NCT01258738|183161497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.239|TWO_SIDED|95.0|-1.04|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.04|0.2390
91634367|NCT01258738|183161498|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634368|NCT01258738|183161498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0928|TWO_SIDED|95.0|-1.0|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.00|0.0928
91634369|NCT01258738|183161498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0139|TWO_SIDED|95.0|-1.27|-0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.15|-1.27|0.0139
91634370|NCT01258738|183161498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0017|TWO_SIDED|95.0|-1.53|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.36|-1.53|0.0017
91634371|NCT01258738|183161498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.0008|TWO_SIDED|95.0|-1.61|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.43|-1.61|0.0008
91634372|NCT01258738|183161499|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634373|NCT01258738|183161499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.4559|TWO_SIDED|95.0|-0.84|0.38|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.38|-0.84|0.4559
91634374|NCT01258738|183161499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0345|TWO_SIDED|95.0|-1.28|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.28|0.0345
91634375|NCT01258738|183161499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.034|TWO_SIDED|95.0|-1.3|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.05|-1.30|0.0340
91634376|NCT01258738|183161499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0634|TWO_SIDED|95.0|-1.24|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.03|-1.24|0.0634
91634377|NCT01258738|183161500|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634378|NCT01258738|183161500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.0007|TWO_SIDED|95.0|-1.56|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.43|-1.56|0.0007
91484595|NCT02038452|182843156|SUPERIORITY||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.034|0.027|||Regression, Linear|||||0.027|-0.034|
91484596|NCT02038452|182843157|SUPERIORITY||Mean Difference (Final Values)|-0.022|||||TWO_SIDED|95.0|-0.093|0.045|||Regression, Linear|||||0.045|-0.093|
91667589|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.697||||0.0403|TWO_SIDED|95.0|1.16|662.2|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||662.20|1.16|0.0403
91667590|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.247||||0.0361|TWO_SIDED|95.0|1.25|733.32|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.32|1.25|0.0361
91667591|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|89.341||||0.0069|TWO_SIDED|95.0|3.43|2326.44|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2326.44|3.43|0.0069
91667592|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|76.034||||0.0081|TWO_SIDED|95.0|3.08|1875.15|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1875.15|3.08|0.0081
91667593|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.9931|TWO_SIDED|95.0|0.02|64.41|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||64.41|0.02|0.9931
91667594|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.943||||0.0259|TWO_SIDED|95.0|1.55|975.84|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||975.84|1.55|0.0259
91667595|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|57.766||||0.0142|TWO_SIDED|95.0|2.26|1477.88|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1477.88|2.26|0.0142
91667596|NCT01243151|183229302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|48.734||||0.0179|TWO_SIDED|95.0|1.95|1216.9|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1216.90|1.95|0.0179
91667597|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|353.058||||0.0013|TWO_SIDED|95.0|9.95|12528.19|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||12528.19|9.95|0.0013
91667598|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|129.984||||0.0047|TWO_SIDED|95.0|4.44|3808.21|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3808.21|4.44|0.0047
91667599|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|300.099||||0.0018|TWO_SIDED|95.0|8.35|10787.45|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||10787.45|8.35|0.0018
91667600|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|190.835||||0.0025|TWO_SIDED|95.0|6.34|5743.12|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||5743.12|6.34|0.0025
91667601|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|255.421||||0.0018|TWO_SIDED|95.0|7.87|8290.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8290.22|7.87|0.0018
91714442|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|STANDARD_ERROR_OF_MEAN|5.98||0.0537||95.0|-0.2|23.4|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.4|-0.2|0.0537
91484597|NCT02035475|182843173|SUPERIORITY_OR_OTHER|||||||0.412|||||||McNemar|||The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.||||0.412
91667602|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|150.547||||0.0034|TWO_SIDED|95.0|5.28|4291.89|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4291.89|5.28|0.0034
91667603|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|745.542||||0.0018|TWO_SIDED|95.0|11.6|47929.45|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||47929.45|11.60|0.0018
91667604|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|146.296||||0.0031|TWO_SIDED|95.0|5.4|3963.01|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3963.01|5.40|0.0031
91667605|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|213.512||||0.002|TWO_SIDED|95.0|7.13|6396.64|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6396.64|7.13|0.0020
91484598|NCT01302379|182843179|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED|95.0|-97.5|97.5||No adjustment for multiple comparisons|Mixed Models Analysis|||||97.5|-97.5|<0.05
91667606|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|124.439||||0.0038|TWO_SIDED|95.0|4.73|3277.13|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3277.13|4.73|0.0038
91667607|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|622.309||||0.002|TWO_SIDED|95.0|10.51|36846.03|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||36846.03|10.51|0.0020
91667608|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|224.427||||0.0017|TWO_SIDED|95.0|7.63|6598.0|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6598.00|7.63|0.0017
91667609|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.158||||0.2751|TWO_SIDED|95.0|0.24|161.08|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||161.08|0.24|0.2751
91667610|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|152.977||||0.0038|TWO_SIDED|95.0|5.05|4633.92|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4633.92|5.05|0.0038
91484599|NCT01842815|182843180|SUPERIORITY|||||||0.0077||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0077
91484600|NCT01842815|182843181|SUPERIORITY|||||||0.00012||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.00012
91634379|NCT01258738|183161500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0073|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.22|-1.39|0.0073
91634380|NCT01258738|183161500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0094|TWO_SIDED|95.0|-1.48|-0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.21|-1.48|0.0094
91634381|NCT01258738|183161500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.012|TWO_SIDED|95.0|-1.54|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.54|0.0120
91634382|NCT01258738|183161501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96||||0.0029|TWO_SIDED|95.0|7.54|32.37|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||32.37|7.54|0.0029
91634383|NCT01258738|183161501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.59||||0.01|TWO_SIDED|95.0|3.18|19.99|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.99|3.18|0.0100
91634384|NCT01258738|183161501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.75||||0.012|TWO_SIDED|95.0|3.62|23.89|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||23.89|3.62|0.0120
91634385|NCT01258738|183161501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12||||0.0213|TWO_SIDED|95.0|3.04|27.2|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||27.20|3.04|0.0213
91634386|NCT01258738|183161502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.2755|TWO_SIDED|95.0|-5.15|20.92|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||20.92|-5.15|0.2755
91634387|NCT01258738|183161502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57||||0.195|TWO_SIDED|95.0|-4.39|21.54|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||21.54|-4.39|0.1950
91634388|NCT01258738|183161502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.99||||0.0278|TWO_SIDED|95.0|0.72|27.26|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||27.26|0.72|0.0278
91634389|NCT01258738|183161502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.29||||0.0174|TWO_SIDED|95.0|2.28|28.3|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||28.30|2.28|0.0174
91634390|NCT01258738|183161503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634391|NCT01258738|183161503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0201|TWO_SIDED|95.0|-0.99|-0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4||-0.09|-0.99|0.0201
91634392|NCT01258738|183161503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0558|TWO_SIDED|95.0|-1.02|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12||0.01|-1.02|0.0558
91634393|NCT01258738|183161504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634394|NCT01258738|183161504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6741|TWO_SIDED|95.0|-0.18|0.28|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.28|-0.18|0.6741
91634395|NCT01258738|183161504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3896|TWO_SIDED|95.0|-0.33|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.13|-0.33|0.3896
91484601|NCT01842815|182843182|SUPERIORITY|||||||0.0034||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0034
91484602|NCT01532973|182843190|SUPERIORITY_OR_OTHER||Difference in LS Means|4.26|||||TWO_SIDED|90.0|3.77|4.74||||||||4.74|3.77|
91634396|NCT01258738|183161504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.7468|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.31|-0.22|0.7468
91634397|NCT01258738|183161504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.6871|TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.23|-0.35|0.6871
91634398|NCT01258738|183161505|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634399|NCT01258738|183161505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.4332|TWO_SIDED|95.0|-0.57|1.32|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||1.32|-0.57|0.4332
91634400|NCT01258738|183161505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9947|TWO_SIDED|95.0|-0.98|0.98|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.98|-0.98|0.9947
91634401|NCT01258738|183161505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.1558|TWO_SIDED|95.0|-0.28|1.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.75|-0.28|0.1558
91634402|NCT01258738|183161505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.0488|TWO_SIDED|95.0|0.03|2.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||2.39|0.03|0.0488
91634403|NCT01258738|183161506|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634404|NCT01258738|183161506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.7645|TWO_SIDED|95.0|-2.06|2.8|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||2.80|-2.06|0.7645
91634405|NCT01258738|183161506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.4178|TWO_SIDED|95.0|-1.48|3.55|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||3.55|-1.48|0.4178
91634406|NCT01258738|183161506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.443|TWO_SIDED|95.0|-1.67|3.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||3.79|-1.67|0.4430
91634407|NCT01258738|183161506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.1095|TWO_SIDED|95.0|-0.54|5.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||5.31|-0.54|0.1095
91634408|NCT01258738|183161507|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634409|NCT01258738|183161507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9504|TWO_SIDED|95.0|-0.46|0.49|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.49|-0.46|0.9504
91634410|NCT01258738|183161507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4971|TWO_SIDED|95.0|-0.7|0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.34|-0.70|0.4971
91634411|NCT01258738|183161507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8999|TWO_SIDED|95.0|-0.47|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.54|-0.47|0.8999
91634412|NCT01258738|183161507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9712|TWO_SIDED|95.0|-0.6|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.62|-0.60|0.9712
91484603|NCT01532973|182843190|SUPERIORITY_OR_OTHER||Difference in LS Means|4.41|||||TWO_SIDED|90.0|3.92|4.9||||||||4.90|3.92|
91634413|NCT01258738|183161508|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91667611|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|756.203||||0.002|TWO_SIDED|95.0|11.18|51133.53|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||51133.53|11.18|0.0020
91667612|NCT01243151|183229303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|258.938||||0.0021|TWO_SIDED|95.0|7.53|8902.61|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8902.61|7.53|0.0021
91667613|NCT01243151|183229304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.958|TWO_SIDED|95.0|0.02|52.79|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||52.79|0.02|0.9580
91484604|NCT01532973|182843190|SUPERIORITY_OR_OTHER||Difference in LS Means|3.56|||||TWO_SIDED|90.0|3.08|4.05||||||||4.05|3.08|
91667614|NCT01243151|183229304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.375||||0.0732|TWO_SIDED|95.0|0.76|394.65|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||394.65|0.76|0.0732
91667615|NCT01243151|183229304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.86||||0.0159|TWO_SIDED|95.0|2.07|1109.11|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1109.11|2.07|0.0159
91714443|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.99||0.0772||95.0|-1.2|22.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.4|-1.2|0.0772
91714444|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|5.81||0.1296||95.0|-2.6|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-2.6|0.1296
91714445|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|6.06||0.014||95.0|3.1|27.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||27.0|3.1|0.0140
91484605|NCT01532973|182843191|SUPERIORITY_OR_OTHER||Difference in LS Means|1.02|||||TWO_SIDED|90.0|0.34|1.69||||||||1.69|0.34|
91667616|NCT01243151|183229304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.246||||0.0264|TWO_SIDED|95.0|1.51|733.62|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.62|1.51|0.0264
91667617|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|5.131||0.2883|TWO_SIDED|95.0|-4.77|15.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.77|-4.77|0.2883
91667618|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05|STANDARD_ERROR_OF_MEAN|5.277||0.2563|TWO_SIDED|95.0|-4.51|16.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.61|-4.51|0.2563
91667619|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|5.225||0.7149|TWO_SIDED|95.0|-8.54|12.37|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-8.54|0.7149
91667620|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|5.174||0.448|TWO_SIDED|95.0|-6.4|14.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.30|-6.40|0.4480
91667621|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|6.214||0.0231|TWO_SIDED|95.0|2.06|26.94|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.94|2.06|0.0231
91667622|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|11.13|STANDARD_ERROR_OF_MEAN|6.369||0.0858|TWO_SIDED|95.0|-1.62|23.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.87|-1.62|0.0858
91667623|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|7.57|STANDARD_ERROR_OF_MEAN|6.431||0.244|TWO_SIDED|95.0|-5.3|20.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.44|-5.30|0.2440
91667624|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|STANDARD_ERROR_OF_MEAN|6.249||0.0702|TWO_SIDED|95.0|-0.98|24.03|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.03|-0.98|0.0702
91484606|NCT01532973|182843191|SUPERIORITY_OR_OTHER||Difference in LS Means|2.07|||||TWO_SIDED|90.0|1.39|2.74||||||||2.74|1.39|
91634414|NCT01258738|183161508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.4556|TWO_SIDED|95.0|-1.46|3.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||3.24|-1.46|0.4556
91667625|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|9.64|STANDARD_ERROR_OF_MEAN|4.878||0.0531|TWO_SIDED|95.0|-0.13|19.41|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.41|-0.13|0.0531
91667626|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|8.93|STANDARD_ERROR_OF_MEAN|4.94||0.0758|TWO_SIDED|95.0|-0.96|18.83|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.83|-0.96|0.0758
91484607|NCT01532973|182843191|SUPERIORITY_OR_OTHER||Difference in LS Means|2.72|||||TWO_SIDED|90.0|2.05|3.39||||||||3.39|2.05|
91484608|NCT01532973|182843192|SUPERIORITY_OR_OTHER||Difference in LS Means|3.2|||||TWO_SIDED|90.0|2.68|3.72||||||||3.72|2.68|
91484609|NCT01532973|182843192|SUPERIORITY_OR_OTHER||Difference in LS Means|3.95|||||TWO_SIDED|90.0|3.44|4.47||||||||4.47|3.44|
91484610|NCT01532973|182843193|SUPERIORITY_OR_OTHER||Difference in LS Means|3.89|||||TWO_SIDED|90.0|3.2|4.58||||||||4.58|3.20|
91484611|NCT01532973|182843193|SUPERIORITY_OR_OTHER||Difference in LS Means|4.67|||||TWO_SIDED|90.0|3.98|5.36||||||||5.36|3.98|
91484612|NCT01532973|182843193|SUPERIORITY_OR_OTHER||Difference in LS Means|3.61|||||TWO_SIDED|90.0|2.92|4.3||||||||4.30|2.92|
91484613|NCT01532973|182843194|SUPERIORITY_OR_OTHER||Difference in LS Means|0.72|||||TWO_SIDED|90.0|-0.09|1.54||||||||1.54|-0.09|
91484614|NCT01532973|182843194|SUPERIORITY_OR_OTHER||Difference in LS Means|2.57|||||TWO_SIDED|90.0|1.75|3.39||||||||3.39|1.75|
91484615|NCT01532973|182843194|SUPERIORITY_OR_OTHER||Difference in LS Means|2.84|||||TWO_SIDED|90.0|2.02|3.66||||||||3.66|2.02|
91634415|NCT01258738|183161508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85||||0.0543|TWO_SIDED|95.0|-0.05|5.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||5.75|-0.05|0.0543
91634416|NCT01258738|183161508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26||||0.1754|TWO_SIDED|95.0|-1.02|5.53|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||5.53|-1.02|0.1754
91484616|NCT01532973|182843195|SUPERIORITY_OR_OTHER||Difference in LS Means|3.17|||||TWO_SIDED|90.0|2.55|3.8||||||||3.80|2.55|
91484617|NCT01532973|182843195|SUPERIORITY_OR_OTHER||Difference in LS Means|3.63|||||TWO_SIDED|90.0|3.0|4.26||||||||4.26|3.00|
91484618|NCT01828320|182843232|SUPERIORITY||d (effect size)|-0.08||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.34
91484619|NCT01828320|182843233|SUPERIORITY||d (effect size)|-0.06||||0.93|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.93
91484620|NCT01828320|182843234|SUPERIORITY||d (effect size)|-0.5||||0.01|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.01
91484621|NCT01828320|182843235|SUPERIORITY||d (effect size)|0.18||||0.17|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.17
91484622|NCT01828320|182843236|SUPERIORITY||d (effect size)|0.07||||0.31|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.31
91484623|NCT01828320|182843237|SUPERIORITY||d (effect size)|0.001||||0.8|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.80
91484624|NCT01828320|182843238|SUPERIORITY||d (effect size)|0.04||||0.96|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.96
91484625|NCT01828320|182843239|SUPERIORITY||d (effect size)|-0.05||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
91484626|NCT01828320|182843240|SUPERIORITY||d (effect size)|0.35||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
91484627|NCT01828320|182843241|SUPERIORITY||d (effect size)|0.28||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
91667627|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|4.975||0.6965|TWO_SIDED|95.0|-8.01|11.92|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.92|-8.01|0.6965
91667628|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|13.52|STANDARD_ERROR_OF_MEAN|4.842||0.0071|TWO_SIDED|95.0|3.83|23.22|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.22|3.83|0.0071
91484628|NCT01828320|182843242|SUPERIORITY||d (effect size)|0.29||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
91484629|NCT01828320|182843243|SUPERIORITY||d (effect size)|-0.44||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.03
91484630|NCT01828320|182843244|SUPERIORITY||d (effect size)|0.07||||0.71|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.71
91484631|NCT01828320|182843245|SUPERIORITY||d (effect size)|0.02||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
91634417|NCT01258738|183161508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||0.3985|TWO_SIDED|95.0|-1.93|4.82|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||4.82|-1.93|0.3985
91634418|NCT01258738|183161509|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91667629|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|5.155||0.0339|TWO_SIDED|95.0|0.88|21.52|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.52|0.88|0.0339
91667630|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|8.56|STANDARD_ERROR_OF_MEAN|5.235||0.1075|TWO_SIDED|95.0|-1.92|19.03|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.03|-1.92|0.1075
91484632|NCT01828320|182843246|SUPERIORITY||d (effect size)|-0.11||||0.85|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.85
91484633|NCT01828320|182843247|SUPERIORITY||d (effect size)|-0.55||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
91634419|NCT01258738|183161509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.2823|TWO_SIDED|95.0|-0.18|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.62|-0.18|0.2823
91634420|NCT01258738|183161509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.4029|TWO_SIDED|95.0|-0.23|0.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.58|-0.23|0.4029
91634421|NCT01258738|183161509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.511|TWO_SIDED|95.0|-0.25|0.51|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.51|-0.25|0.5110
91634422|NCT01258738|183161509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.5844|TWO_SIDED|95.0|-0.32|0.56|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.56|-0.32|0.5844
91634423|NCT01258738|183161510|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634424|NCT01258738|183161510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0129|TWO_SIDED|95.0|-0.95|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.11|-0.95|0.0129
91634425|NCT01258738|183161510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.6003|TWO_SIDED|95.0|-0.61|0.35|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.35|-0.61|0.6003
91667631|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|5.98|STANDARD_ERROR_OF_MEAN|5.258||0.2601|TWO_SIDED|95.0|-4.54|16.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.50|-4.54|0.2601
91667632|NCT01243151|183229305|SUPERIORITY_OR_OTHER||LS Mean Difference|9.96|STANDARD_ERROR_OF_MEAN|5.132||0.057|TWO_SIDED|95.0|-0.31|20.24|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.24|-0.31|0.0570
91667633|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.88|STANDARD_ERROR_OF_MEAN|5.008|<|0.0001|TWO_SIDED|95.0|-42.93|-22.84|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.84|-42.93|<0.0001
91667634|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-41.34|-20.26|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.26|-41.34|<0.0001
91525820|NCT02567825|182927159|SUPERIORITY||Difference of least-squares means|-6.32|||||TWO_SIDED|95.0|-7.55|-5.1|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience AOM symptoms with an intact TM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-5.10|-7.55|
91634426|NCT01258738|183161510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0911|TWO_SIDED|95.0|-0.89|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.07|-0.89|0.0911
91634427|NCT01258738|183161510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.3144|TWO_SIDED|95.0|-0.73|0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.24|-0.73|0.3144
91634428|NCT01258738|183161511|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634429|NCT01258738|183161511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.6476|TWO_SIDED|95.0|-0.46|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2||0.29|-0.46|0.6476
91634430|NCT01258738|183161511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9777|TWO_SIDED|95.0|-0.4|0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4||0.39|-0.40|0.9777
91667635|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.98|STANDARD_ERROR_OF_MEAN|5.088|<|0.0001|TWO_SIDED|95.0|-50.18|-29.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.77|-50.18|<0.0001
91634431|NCT01258738|183161511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.4453|TWO_SIDED|95.0|-0.28|0.65|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8||0.65|-0.28|0.4453
91634432|NCT01258738|183161511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.5782|TWO_SIDED|95.0|-0.33|0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12||0.60|-0.33|0.5782
91634433|NCT01258738|183161512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
91634434|NCT01258738|183161513|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634435|NCT01258738|183161513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93|||<|0.001|TWO_SIDED|95.0|-4.16|-1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-1.70|-4.16|<0.001
91634436|NCT01258738|183161514|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634437|NCT01258738|183161514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
91634438|NCT01258738|183161515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0132|TWO_SIDED|95.0|-0.72|-0.08|||ANCOVA|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||-0.08|-0.72|0.0132
91634439|NCT01258738|183161516|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634440|NCT01258738|183161516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2438|TWO_SIDED|95.0|-0.52|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.13|-0.52|0.2438
91634441|NCT01258738|183161516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1958|TWO_SIDED|95.0|-0.42|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.09|-0.42|0.1958
91667636|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.37|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-48.54|-28.2|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.20|-48.54|<0.0001
91634442|NCT01258738|183161516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1624|TWO_SIDED|95.0|-0.46|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.08|-0.46|0.1624
91634443|NCT01258738|183161516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0091|TWO_SIDED|95.0|-0.54|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.08|-0.54|0.0091
91792555|NCT02129777|183462752|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.497||0.087|TWO_SIDED|95.0|-1.85|0.13|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.13|-1.85|0.087
91634444|NCT01258738|183161517|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634445|NCT01258738|183161517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0836|TWO_SIDED|95.0|-1.32|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.32|0.0836
91667637|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.18|STANDARD_ERROR_OF_MEAN|6.271|<|0.0001|TWO_SIDED|95.0|-54.73|-29.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.63|-54.73|<0.0001
91667638|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.69|STANDARD_ERROR_OF_MEAN|6.512|<|0.0001|TWO_SIDED|95.0|-55.72|-29.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.67|-55.72|<0.0001
91667639|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.56|STANDARD_ERROR_OF_MEAN|6.445|<|0.0001|TWO_SIDED|95.0|-67.45|-41.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.67|-67.45|<0.0001
91792556|NCT02129777|183462752|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.494||0.58|TWO_SIDED|95.0|-1.26|0.71|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.71|-1.26|0.580
91634446|NCT01258738|183161517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5402|TWO_SIDED|95.0|-1.02|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.54|-1.02|0.5402
91634447|NCT01258738|183161517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8167|TWO_SIDED|95.0|-0.69|0.87|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.87|-0.69|0.8167
91634448|NCT01258738|183161517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9891|TWO_SIDED|95.0|-0.72|0.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.73|-0.72|0.9891
91634449|NCT01258738|183161518|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634450|NCT01258738|183161518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6148|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.05|-0.08|0.6148
91634451|NCT01258738|183161518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2547|TWO_SIDED|95.0|-0.11|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.03|-0.11|0.2547
91667640|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.89|STANDARD_ERROR_OF_MEAN|6.321|<|0.0001|TWO_SIDED|95.0|-64.54|-39.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.25|-64.54|<0.0001
91667641|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.35|STANDARD_ERROR_OF_MEAN|5.359||95|TWO_SIDED|95.0|-58.1|-36.59|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.59|-58.10|95
91667642|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.08|STANDARD_ERROR_OF_MEAN|5.566|<|0.0001|TWO_SIDED|95.0|-62.24|-39.91|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.91|-62.24|<0.0001
91667643|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.89|STANDARD_ERROR_OF_MEAN|5.482|<|0.0001|TWO_SIDED|95.0|-70.89|-48.89|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.89|-70.89|<0.0001
91634452|NCT01258738|183161518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1208|TWO_SIDED|95.0|-0.08|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.01|-0.08|0.1208
91484634|NCT01828320|182843248|SUPERIORITY||d (effect size)|-0.33||||0.05|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.05
91484635|NCT01828320|182843249|SUPERIORITY||d (effect size)|0.04||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.88
91484636|NCT01828320|182843250|SUPERIORITY||d (effect size)|0.04||||0.97|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.97
91484637|NCT01828320|182843251|SUPERIORITY||d (effect size)|0.01||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: Alone"||||0.88
91634453|NCT01258738|183161518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.8291|TWO_SIDED|95.0|-0.13|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.17|-0.13|0.8291
91634454|NCT01258738|183161519|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634455|NCT01258738|183161519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.3536|TWO_SIDED|95.0|-0.64|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.23|-0.64|0.3536
91634456|NCT01258738|183161519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0769|TWO_SIDED|95.0|-0.97|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.05|-0.97|0.0769
91634457|NCT01258738|183161519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4698|TWO_SIDED|95.0|-0.7|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.33|-0.70|0.4698
91634458|NCT01258738|183161519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0167|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.12|-1.19|0.0167
91634459|NCT01258738|183161520|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
91634460|NCT01258738|183161520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||<|0.0001|TWO_SIDED|95.0|-4.39|-1.66|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.66|-4.39|<0.0001
91634461|NCT01258738|183161520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.86||||0.0008|TWO_SIDED|95.0|-6.09|-1.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-1.62|-6.09|0.0008
91634462|NCT01258738|183161520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0143|TWO_SIDED|95.0|-5.47|-0.61|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.61|-5.47|0.0143
91634463|NCT01258738|183161520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0038|TWO_SIDED|95.0|-5.23|-1.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-1.02|-5.23|0.0038
91634464|NCT01258738|183161521|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test||||<0.001
91634465|NCT01258738|183161521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.0001|TWO_SIDED|95.0|-10.85|-4.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-4.58|-10.85|<0.0001
91634466|NCT01258738|183161521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|||<|0.0001|TWO_SIDED|95.0|-9.16|-3.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-3.09|-9.16|<0.0001
91634467|NCT01258738|183161521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.78||||0.0009|TWO_SIDED|95.0|-9.15|-2.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-2.41|-9.15|0.0009
91634468|NCT01258738|183161521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03|||<|0.0001|TWO_SIDED|95.0|-10.34|-3.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-3.73|-10.34|<0.0001
91667644|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.03|STANDARD_ERROR_OF_MEAN|5.377|<|0.0001|TWO_SIDED|95.0|-67.83|-46.24|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.24|-67.83|<0.0001
91634469|NCT01258738|183161522|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were \<0.001, from paired t-test.||||0.0370
91634470|NCT01258738|183161522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9965|TWO_SIDED|95.0|-4.39|4.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||4.37|-4.39|0.9965
91667645|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.06|STANDARD_ERROR_OF_MEAN|5.767|<|0.0001|TWO_SIDED|95.0|-60.61|-37.51|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.51|-60.61|<0.0001
91667646|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.52|STANDARD_ERROR_OF_MEAN|5.974|<|0.0001|TWO_SIDED|95.0|-63.48|-39.56|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.56|-63.48|<0.0001
91667647|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|5.901|<|0.0001|TWO_SIDED|95.0|-76.04|-52.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.40|-76.04|<0.0001
91667648|NCT01243151|183229306|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.01|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-71.59|-48.42|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.42|-71.59|<0.0001
91714446|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.93||0.0642||95.0|-0.7|22.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.7|-0.7|0.0642
91634471|NCT01258738|183161522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61||||0.197|TWO_SIDED|95.0|-1.89|9.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||9.10|-1.89|0.1970
91634472|NCT01258738|183161522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.07||||0.0394|TWO_SIDED|95.0|0.3|11.84|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||11.84|0.30|0.0394
91634473|NCT01258738|183161523|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.01 at Week 12 and \<0.001 thereafter, from paired t-test.||||<0.01
91634474|NCT01258738|183161523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1341|TWO_SIDED|95.0|-0.02|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||0.21|-0.02|0.1341
91634475|NCT01258738|183161523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.0447|TWO_SIDED|95.0|0.0|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||0.14|0.00|0.0447
91667649|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.91|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-75.54|-34.29|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.29|-75.54|<0.0001
91667650|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.07|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-65.21|-22.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.94|-65.21|<0.0001
91667651|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.98|STANDARD_ERROR_OF_MEAN|10.547|<|0.0001|TWO_SIDED|95.0|-88.92|-47.05|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.05|-88.92|<0.0001
91667652|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.51|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-81.11|-39.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.90|-81.11|<0.0001
91667653|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.39|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-89.02|-47.76|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.76|-89.02|<0.0001
91667654|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.41|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-81.54|-39.27|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.27|-81.54|<0.0001
91667655|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.6|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-107.74|-65.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-65.46|-107.74|<0.0001
91634476|NCT01258738|183161523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.1345|TWO_SIDED|95.0|-0.02|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||0.13|-0.02|0.1345
91634477|NCT01258738|183161524|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634478|NCT01258738|183161524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31||||0.1035|TWO_SIDED|95.0|-0.27|2.9|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||2.90|-0.27|0.1035
91634479|NCT01258738|183161524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.0134|TWO_SIDED|95.0|0.5|4.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||4.26|0.50|0.0134
91667656|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-81.13|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-101.73|-60.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.52|-101.73|<0.0001
91484638|NCT01828320|182843251|SUPERIORITY||d (effect size)|-0.18||||0.43|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a family member"||||0.43
91634480|NCT01258738|183161525|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
91634481|NCT01258738|183161525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.252|TWO_SIDED|95.0|-0.84|3.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||3.19|-0.84|0.2520
91634482|NCT01258738|183161525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.4981|TWO_SIDED|95.0|-1.63|3.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||3.34|-1.63|0.4981
91634483|NCT01258738|183161526|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634484|NCT01258738|183161526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.4621|TWO_SIDED|95.0|-0.9|0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.41|-0.90|0.4621
91634485|NCT01258738|183161526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.3842|TWO_SIDED|95.0|-1.28|0.5|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.50|-1.28|0.3842
91634486|NCT01258738|183161527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634487|NCT01258738|183161527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.6357|TWO_SIDED|95.0|-0.52|0.86|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.86|-0.52|0.6357
91634488|NCT01258738|183161527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2439|TWO_SIDED|95.0|-1.39|0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.36|-1.39|0.2439
91634489|NCT01258738|183161528|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91667657|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-100.96|-59.37|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-59.37|-100.96|<0.0001
91667658|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.0|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-104.14|-61.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.87|-104.14|<0.0001
91634490|NCT01258738|183161528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.3286|TWO_SIDED|95.0|-1.55|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||0.52|-1.55|0.3286
91634491|NCT01258738|183161529|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634492|NCT01258738|183161529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1829|TWO_SIDED|95.0|-1.93|0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||0.37|-1.93|0.1829
91634493|NCT01258738|183161530|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
91634494|NCT01258738|183161530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37||||0.5226|TWO_SIDED|95.0|-4.95|9.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||9.68|-4.95|0.5226
91667659|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.77|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-125.91|-83.62|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-83.62|-125.91|<0.0001
91667660|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.23|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-110.84|-69.63|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.63|-110.84|<0.0001
91634495|NCT01258738|183161530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.6232|TWO_SIDED|95.0|-4.9|8.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||8.14|-4.90|0.6232
91634496|NCT01258738|183161530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.52||||0.3877|TWO_SIDED|95.0|-4.53|11.57|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||11.57|-4.53|0.3877
91634497|NCT01258738|183161530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74||||0.2402|TWO_SIDED|95.0|-3.22|12.69|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||12.69|-3.22|0.2402
91634498|NCT01258738|183161531|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and thereafter, from paired t-test.||||<0.001
91634499|NCT01258738|183161531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.19||||0.0193|TWO_SIDED|95.0|-16.85|-1.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.52|-16.85|0.0193
91634500|NCT01258738|183161531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.08||||0.173|TWO_SIDED|95.0|-12.41|2.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.26|-12.41|0.1730
91634501|NCT01258738|183161531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26||||0.1224|TWO_SIDED|95.0|-14.23|1.71|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.71|-14.23|0.1224
91667661|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-92.34|-50.75|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-50.75|-92.34|<0.0001
91667662|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-74.46|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-95.59|-53.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-53.32|-95.59|<0.0001
91667663|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-102.35|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-123.49|-81.21|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-81.21|-123.49|<0.0001
91667664|NCT01243151|183229307|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.15|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-107.76|-66.55|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.55|-107.76|<0.0001
91634502|NCT01258738|183161531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.14||||0.0461|TWO_SIDED|95.0|-18.11|-0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.16|-18.11|0.0461
91634503|NCT01258738|183161532|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634504|NCT01258738|183161532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97||||0.0372|TWO_SIDED|95.0|-11.58|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.36|-11.58|0.0372
91634505|NCT01258738|183161532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2126|TWO_SIDED|95.0|-7.98|1.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||1.79|-7.98|0.2126
91634506|NCT01258738|183161532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.66||||0.033|TWO_SIDED|95.0|-12.79|-0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.54|-12.79|0.0330
91634507|NCT01258738|183161532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85||||0.0397|TWO_SIDED|95.0|-13.38|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.33|-13.38|0.0397
91667665|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.945||0.3064|TWO_SIDED|95.0|-1.89|5.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||5.90|-1.89|0.3064
91667666|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.025||0.1922|TWO_SIDED|95.0|-1.38|6.73|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.73|-1.38|0.1922
91667667|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.984||0.6827|TWO_SIDED|95.0|-3.16|4.79|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.79|-3.16|0.6827
91667668|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|2.45|STANDARD_ERROR_OF_MEAN|1.981||0.2211|TWO_SIDED|95.0|-1.52|6.42|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.42|-1.52|0.2211
91634508|NCT01258738|183161533|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and at Week 32 and thereafter, from paired t test.||||<0.001
91634509|NCT01258738|183161533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.29||||0.0382|TWO_SIDED|95.0|-16.12|-0.46|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.46|-16.12|0.0382
91634510|NCT01258738|183161533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.1648|TWO_SIDED|95.0|-12.69|2.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.19|-12.69|0.1648
91667669|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|6.64|STANDARD_ERROR_OF_MEAN|2.158||0.0033|TWO_SIDED|95.0|2.31|10.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.97|2.31|0.0033
91667670|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|5.09|STANDARD_ERROR_OF_MEAN|2.237||0.0269|TWO_SIDED|95.0|0.6|9.57|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.57|0.60|0.0269
91667671|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|2.232||0.089|TWO_SIDED|95.0|-0.61|8.34|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.34|-0.61|0.0890
91667672|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|2.19||0.0242|TWO_SIDED|95.0|0.69|9.47|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.47|0.69|0.0242
91714447|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|5.92||0.073||95.0|-1.0|22.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.3|-1.0|0.0730
91667673|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|2.101||0.127|TWO_SIDED|95.0|-0.95|7.46|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-0.95|0.1270
91667674|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.151||0.1199|TWO_SIDED|95.0|-0.91|7.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.70|-0.91|0.1199
91714448|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|6.01||0.0215||95.0|2.1|25.8|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.8|2.1|0.0215
91792557|NCT02129777|183462752|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.496||0.873|TWO_SIDED|95.0|-1.06|0.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.90|-1.06|0.873
91634511|NCT01258738|183161533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.1476|TWO_SIDED|95.0|-14.11|2.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||2.15|-14.11|0.1476
91714449|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.84||0.3785||95.0|-6.4|16.7|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.7|-6.4|0.3785
91714450|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|6.12||0.0089||95.0|4.1|28.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.2|4.1|0.0089
91714451|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|5.96||0.0609||95.0|-0.5|23.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.0|-0.5|0.0609
91714452|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.95||0.0064||95.0|4.7|28.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.1|4.7|0.0064
91714453|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|6.01||0.0241||95.0|1.8|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|1.8|0.0241
91484639|NCT01828320|182843251|SUPERIORITY||d (effect size)|0.21||||0.37|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a peer"||||0.37
91634512|NCT01258738|183161533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.68||||0.0687|TWO_SIDED|95.0|-18.03|0.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.68|-18.03|0.0687
91634513|NCT01258738|183161534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634514|NCT01258738|183161534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2578|TWO_SIDED|95.0|-1.21|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.33|-1.21|0.2578
91634515|NCT01258738|183161534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4334|TWO_SIDED|95.0|-1.21|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.52|-1.21|0.4334
91634516|NCT01258738|183161535|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
91634517|NCT01258738|183161535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3554|TWO_SIDED|95.0|-4.7|1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||1.70|-4.70|0.3554
91484640|NCT01828320|182843252|SUPERIORITY||d (effect size)|0.29||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
91634518|NCT01258738|183161535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.335|TWO_SIDED|95.0|-5.82|1.99|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||1.99|-5.82|0.3350
91634519|NCT01258738|183161536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41||||14.41|TWO_SIDED|95.0|0.04|28.78|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||28.78|0.04|14.41
91634520|NCT01258738|183161537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.03||||0.1285|TWO_SIDED|95.0|-2.51|24.56|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||24.56|-2.51|0.1285
91634521|NCT03798366|183161589|SUPERIORITY||Least square (LS) mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.29||0.6757|TWO_SIDED|95.0|-3.1|2.0|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||2.0|-3.1|0.6757
91634522|NCT03798366|183161590|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|1.31||0.6079|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||1.9|-3.3|0.6079
91634523|NCT03798366|183161591|SUPERIORITY||LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.35||0.1298|TWO_SIDED|95.0|-4.8|0.6|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||0.6|-4.8|0.1298
91634524|NCT03798366|183161592|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.36||0.0411|TWO_SIDED|95.0|-5.6|-0.1|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||-0.1|-5.6|0.0411
91634525|NCT00474539|183161594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.5||||||95.0|-3.3|2.0||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at \>=1:8 titer was calculated||2.0|-3.3|
91667675|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.15||0.8123|TWO_SIDED|95.0|-3.79|4.82|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.82|-3.79|0.8123
91667676|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|2.106||0.0095|TWO_SIDED|95.0|1.44|9.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.87|1.44|0.0095
91667677|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.492||0.1141|TWO_SIDED|95.0|-0.99|8.99|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.99|-0.99|0.1141
91667678|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.536||0.1552|TWO_SIDED|95.0|-1.42|8.73|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.73|-1.42|0.1552
91667679|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|1.57|STANDARD_ERROR_OF_MEAN|2.547||0.5407|TWO_SIDED|95.0|-3.53|6.67|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.67|-3.53|0.5407
91667680|NCT01243151|183229308|SUPERIORITY_OR_OTHER||LS Mean Difference|6.56|STANDARD_ERROR_OF_MEAN|2.485||0.0107|TWO_SIDED|95.0|1.58|11.53|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.53|1.58|0.0107
91667681|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.35|STANDARD_ERROR_OF_MEAN|8.152|<|0.0001|TWO_SIDED|95.0|-76.74|-43.97|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.97|-76.74|<0.0001
91484641|NCT01828320|182843253|SUPERIORITY||d (effect size)|0.07||||0.49|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.49
91714454|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|5.86||0.1032||95.0|-2.0|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.0|0.1032
91634526|NCT00474539|183161597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.08|0.69|
91667682|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.53|STANDARD_ERROR_OF_MEAN|8.422|<|0.0001|TWO_SIDED|95.0|-69.45|-35.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.61|-69.45|<0.0001
91667683|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-69.46|STANDARD_ERROR_OF_MEAN|8.26|<|0.0001|TWO_SIDED|95.0|-86.06|-52.86|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.86|-86.06|<0.0001
91667684|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.25|STANDARD_ERROR_OF_MEAN|8.112|<|0.0001|TWO_SIDED|95.0|-82.55|-49.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.94|-82.55|<0.0001
91484642|NCT01828320|182843254|SUPERIORITY||d (effect size)|0.11||||0.6|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.60
91484643|NCT01828320|182843255|SUPERIORITY||d (effect size)|0.08||||0.42|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.42
91634527|NCT00474539|183161597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23||||||95.0|0.97|1.55||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.55|0.97|
91634528|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-3.5|2.0||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.0|-3.5|
91634529|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.9|1.7||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||1.7|-1.9|
91634530|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.2||||||95.0|-4.4|4.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||4.0|-4.4|
91634531|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-2.1|2.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.0|-2.1|
91634532|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.2|
91634533|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.2|
91634534|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.3|
91634535|NCT00474539|183161598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.3|
91634536|NCT00474539|183161599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.72|1.03||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.03|0.72|
91634537|NCT00474539|183161599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.74|1.12||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.12|0.74|
91634538|NCT00474539|183161599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93||||||95.0|0.78|1.1||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.78|
91634539|NCT00474539|183161599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.24||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.24|0.81|
91634540|NCT00474539|183161602|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.6||||||95.0|-1.7|3.2||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.||3.2|-1.7|
91634541|NCT01117428|183161604|EQUIVALENCE|Differences between Parts E and F in terms of Best Overall Response evaluated from screening until disease progression.||||||0.6645||||||No adjustment, 5% significance level|Fisher Exact|||||||0.6645
91634542|NCT00242710|183161638|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.56|3.18|||ANCOVA|||An analysis of covariance (ANCOVA) model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.18|1.56|<0.001
91634543|NCT00242710|183161638|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.56|3.17|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.17|1.56|<0.001
91634544|NCT00242710|183161638|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|||<|0.001|TWO_SIDED|95.0|2.81|4.76|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.76|2.81|<0.001
91634545|NCT00242710|183161640|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.97|2.24|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.24|0.97|<0.001
91634546|NCT00242710|183161640|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.19|2.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.46|1.19|<0.001
91667685|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.46|STANDARD_ERROR_OF_MEAN|10.766|<|0.0001|TWO_SIDED|95.0|-100.05|-56.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.87|-100.05|<0.0001
91634547|NCT00242710|183161640|SUPERIORITY_OR_OTHER||LS Mean Difference|2.46|||<|0.001|TWO_SIDED|95.0|1.69|3.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.23|1.69|<0.001
91634548|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.373|TWO_SIDED|95.0|-0.8|2.12|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.12|-0.80|0.373
91634549|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.738|TWO_SIDED|95.0|-1.7|2.4|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.40|-1.70|0.738
91634550|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.539|TWO_SIDED|95.0|-1.41|2.71|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.71|-1.41|0.539
91634551|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.233|TWO_SIDED|95.0|-0.71|2.9|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.90|-0.71|0.233
91634552|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.605|TWO_SIDED|95.0|-1.39|2.39|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.39|-1.39|0.605
91634553|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23||||0.305|TWO_SIDED|95.0|-1.12|3.57|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.57|-1.12|0.305
91634554|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.299|TWO_SIDED|95.0|-1.08|3.52|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.52|-1.08|0.299
91634555|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62||||0.092|TWO_SIDED|95.0|-0.27|3.51|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.51|-0.27|0.092
91634556|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55||||0.08|TWO_SIDED|95.0|-0.18|3.29|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.29|-0.18|0.080
91634557|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04||||0.279|TWO_SIDED|95.0|-0.85|2.92|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.92|-0.85|0.279
91634558|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13||||0.26|TWO_SIDED|95.0|-0.84|3.11|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.11|-0.84|0.260
91634559|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.618|TWO_SIDED|95.0|-1.5|2.52|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.52|-1.50|0.618
91634560|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.81|TWO_SIDED|95.0|-3.78|2.96|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.96|-3.78|0.810
91634561|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.654|TWO_SIDED|95.0|-1.14|1.81|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.81|-1.14|0.654
91634562|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.834|TWO_SIDED|95.0|-1.84|2.28|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.28|-1.84|0.834
91634563|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.744|TWO_SIDED|95.0|-2.41|1.72|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.72|-2.41|0.744
91634564|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.909|TWO_SIDED|95.0|-1.7|1.91|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.91|-1.70|0.909
91634565|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.963|TWO_SIDED|95.0|-1.94|1.85|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.85|-1.94|0.963
91634566|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.625|TWO_SIDED|95.0|-1.77|2.94|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.94|-1.77|0.625
91634567|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.947|TWO_SIDED|95.0|-2.39|2.23|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.23|-2.39|0.947
91634568|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.505|TWO_SIDED|95.0|-1.25|2.53|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.53|-1.25|0.505
91634569|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.564|TWO_SIDED|95.0|-1.23|2.25|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.25|-1.23|0.564
91634570|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.739|TWO_SIDED|95.0|-2.21|1.57|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.57|-2.21|0.739
91634571|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.766|TWO_SIDED|95.0|-2.27|1.67|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.67|-2.27|0.766
91634572|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.931|TWO_SIDED|95.0|-1.92|2.1|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.10|-1.92|0.931
91634573|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.911|TWO_SIDED|95.0|-3.17|3.56|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.56|-3.17|0.911
91634574|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.003|TWO_SIDED|95.0|0.92|4.3|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.30|0.92|0.003
91634575|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|||<|0.001|TWO_SIDED|95.0|1.79|6.58|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.58|1.79|<0.001
91634576|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45||||0.005|TWO_SIDED|95.0|1.03|5.86|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.86|1.03|0.005
91634577|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.15||||0.004|TWO_SIDED|95.0|1.01|5.3|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.30|1.01|0.004
91634578|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.023|TWO_SIDED|95.0|0.36|4.87|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.87|0.36|0.023
91634579|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75||||0.008|TWO_SIDED|95.0|0.96|6.54|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.54|0.96|0.008
91634580|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.52||||0.012|TWO_SIDED|95.0|0.78|6.26|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.26|0.78|0.012
91634581|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.81|||<|0.001|TWO_SIDED|95.0|1.55|6.07|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.07|1.55|<0.001
91634582|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.68|5.83|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.83|1.68|<0.001
91634583|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.05|5.54|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.54|1.05|0.004
91634584|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63||||0.175|TWO_SIDED|95.0|-0.73|3.99|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.99|-0.73|0.175
91634585|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35||||0.27|TWO_SIDED|95.0|-1.05|3.75|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.75|-1.05|0.270
91634586|NCT00242710|183161641|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78||||0.077|TWO_SIDED|95.0|-0.41|7.97|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||7.97|-0.41|0.077
91634587|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.826|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.826
91634588|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.534|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.534
91634589|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||1.000
91634590|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.516|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.516
91634591|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.446
91634592|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.218
91634593|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||1.000
91634594|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
91634595|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.733
91634596|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.736|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.736
91634597|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.449
91634598|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.489
91634599|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.163|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.163
91634600|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.813|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.813
91634601|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.777|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.777
91634602|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.448
91634603|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.507
91634604|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.669|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.669
91634605|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.281|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.281
91634606|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.689
91525821|NCT02567825|182927160|SUPERIORITY||Difference of least-squares means|-4.5|||||TWO_SIDED|95.0|-6.82|-2.18|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children receive systemic antimicrobials for AOM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-2.18|-6.82|
91525822|NCT02567825|182927161|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom PDD was reported.||1.03|0.44|
91525823|NCT02567825|182927162|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.51|1.22|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom diaper dermatitis was reported.||1.22|0.51|
91525824|NCT02567825|182927163|SUPERIORITY||Risk Ratio (RR)|2.57|||||TWO_SIDED|95.0|1.91|3.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom tube otorrhea was reported.||3.48|1.91|
91525825|NCT02567825|182927164|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children with no pathogens at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.24|0.74|
91525826|NCT02567825|182927164|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.83|1.72|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive only for at least 1 penicillin-susceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.72|0.83|
91525827|NCT02567825|182927164|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.94|1.29|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive for at least 1 penicillin nonsusceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.29|0.94|
91634607|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.437|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||0.437
91634608|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||1.000
91634609|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||1.000
91634610|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.227
91634611|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.758
91634612|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.554
91667686|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.28|STANDARD_ERROR_OF_MEAN|11.051|<|0.0001|TWO_SIDED|95.0|-93.43|-49.13|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.13|-93.43|<0.0001
91634613|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||<0.001
91634614|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||<0.001
91634615|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||<0.001
91634616|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||<0.001
91634617|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||<0.001
91634618|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||<0.001
91634619|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.008
91634620|NCT00242710|183161642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||<0.001
91634621|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.005
91634622|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.008
91634623|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.062
91667687|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-91.83|STANDARD_ERROR_OF_MEAN|11.018|<|0.0001|TWO_SIDED|95.0|-113.92|-69.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.74|-113.92|<0.0001
91634624|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.007
91667688|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.5|STANDARD_ERROR_OF_MEAN|10.736|<|0.0001|TWO_SIDED|95.0|-111.03|-67.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-67.97|-111.03|<0.0001
91667689|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.73|STANDARD_ERROR_OF_MEAN|8.452|<|0.0001|TWO_SIDED|95.0|-103.73|-69.72|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.72|-103.73|<0.0001
91667690|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.18|STANDARD_ERROR_OF_MEAN|8.643|<|0.0001|TWO_SIDED|95.0|-109.57|-74.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.80|-109.57|<0.0001
91667691|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-106.06|STANDARD_ERROR_OF_MEAN|8.585|<|0.0001|TWO_SIDED|95.0|-123.34|-88.78|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-88.78|-123.34|<0.0001
91667692|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-99.18|STANDARD_ERROR_OF_MEAN|8.334|<|0.0001|TWO_SIDED|95.0|-115.95|-82.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-82.40|-115.95|<0.0001
91667693|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-79.07|STANDARD_ERROR_OF_MEAN|8.557|<|0.0001|TWO_SIDED|95.0|-96.22|-61.93|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.93|-96.22|<0.0001
91667694|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.89|STANDARD_ERROR_OF_MEAN|8.736|<|0.0001|TWO_SIDED|95.0|-101.4|-66.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.39|-101.40|<0.0001
91667695|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.74|STANDARD_ERROR_OF_MEAN|8.679|<|0.0001|TWO_SIDED|95.0|-122.13|-87.35|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-87.35|-122.13|<0.0001
91667696|NCT01243151|183229309|SUPERIORITY_OR_OTHER||LS Mean Difference|-97.0|STANDARD_ERROR_OF_MEAN|8.426|<|0.0001|TWO_SIDED|95.0|-113.89|-80.11|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-80.11|-113.89|<0.0001
91525828|NCT02567825|182927165|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.84|1.55|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes of AOM at which a nonsusceptible pathogen is recovered.||1.55|0.84|
91634625|NCT00242710|183161642|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.029
91634626|NCT00242710|183161644|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|1.92|4.58|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.58|1.92|<0.001
91634627|NCT00242710|183161644|SUPERIORITY_OR_OTHER||LS Mean Difference|3.14|||<|0.001|TWO_SIDED|95.0|1.83|4.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.46|1.83|<0.001
91634628|NCT00242710|183161644|SUPERIORITY_OR_OTHER||LS Mean Difference|4.68|||<|0.001|TWO_SIDED|95.0|3.13|6.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||6.23|3.13|<0.001
91667697|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|29.336||0.448|TWO_SIDED|95.0|-80.08|35.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.49|-80.08|0.4480
91667698|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.52|STANDARD_ERROR_OF_MEAN|30.091||0.2809|TWO_SIDED|95.0|-91.8|26.76|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.76|-91.80|0.2809
91667699|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.92|STANDARD_ERROR_OF_MEAN|29.942||0.2875|TWO_SIDED|95.0|-90.9|27.07|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.07|-90.90|0.2875
91667700|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|29.37||0.5743|TWO_SIDED|95.0|-74.38|41.33|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||41.33|-74.38|0.5743
91667701|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.83|STANDARD_ERROR_OF_MEAN|29.336||0.4997|TWO_SIDED|95.0|-77.62|37.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.96|-77.62|0.4997
91667702|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|30.091||0.4756|TWO_SIDED|95.0|-80.78|37.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.78|-80.78|0.4756
91484644|NCT01828320|182843256|SUPERIORITY||d (effect size)|0.4||||0.01|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.01
91634629|NCT00242710|183161645|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|||<|0.001|TWO_SIDED|95.0|0.8|2.87|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.87|0.80|<0.001
91634630|NCT00242710|183161645|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|0.92|2.97|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.97|0.92|<0.001
91667703|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.73|STANDARD_ERROR_OF_MEAN|30.458||0.561|TWO_SIDED|95.0|-77.73|42.26|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||42.26|-77.73|0.5610
91667704|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.41|STANDARD_ERROR_OF_MEAN|29.37||0.4667|TWO_SIDED|95.0|-79.27|36.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||36.44|-79.27|0.4667
91634631|NCT00242710|183161645|SUPERIORITY_OR_OTHER||LS Mean Difference|2.38|||<|0.001|TWO_SIDED|95.0|1.17|3.59|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.59|1.17|<0.001
91634632|NCT00203294|183161656|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.|Fisher Exact|||Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||||<0.01
91634633|NCT00203294|183161656|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||Fisher's exact test was used to compare nominal variables between groups.||||<0.01
91484645|NCT00866788|182843291|SUPERIORITY_OR_OTHER|||||||0.1601||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1601
91484646|NCT00866788|182843291|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
91634634|NCT02177942|183161661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.6931|TWO_SIDED|95.0|-0.2|0.13|||ANCOVA||Difference is test treatment minus control treatment such that a positive difference favours the test treatment.|||0.13|-0.20|0.6931
91634635|NCT03062605|183161670|OTHER|Inequality test||||||0.35||||||Significant at p \< 0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.35
91634636|NCT03062605|183161670|OTHER|Inequality test||||||0.29||||||Significant at p\<0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.29
91634637|NCT03062605|183161670|OTHER|Inequality test||||||0.09||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.09
91634638|NCT03062605|183161670|OTHER|Inequality test||||||0.13||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.13
91634639|NCT01948791|183161673|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of MeanP-MeanB+1.40, the post-baseline noninferiority to baseline can be concluded. If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of 0, superiority can be concluded.|||||<|0.001|||||||t-test, 1 sided|||The hypothesis to test the non-inferiority of post-baseline change in ADAS-Cog from baseline was: H0: μP - μB ≥ 1.40, Ha: μP - μB \< 1.40 where μP and μB are the ADAS-Cog score (actual) at 16 weeks of Rivastigmine treatment and the baseline ADAS-Cog score (actual), respectively.||||<0.001
91634640|NCT00702949|183161685|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
91634641|NCT00702949|183161688|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.002
91634642|NCT00702949|183161689|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.009
91634643|NCT00702949|183161691|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
91667705|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|29.828||0.3045|TWO_SIDED|95.0|-89.45|28.06|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||28.06|-89.45|0.3045
91667706|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.78|STANDARD_ERROR_OF_MEAN|30.091||0.4301|TWO_SIDED|95.0|-83.06|35.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.50|-83.06|0.4301
91667707|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.15|STANDARD_ERROR_OF_MEAN|30.458||0.0881|TWO_SIDED|95.0|-112.15|7.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.85|-112.15|0.0881
91667708|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.51|STANDARD_ERROR_OF_MEAN|29.37||0.2844|TWO_SIDED|95.0|-89.36|26.35|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.35|-89.36|0.2844
91667709|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.56|STANDARD_ERROR_OF_MEAN|29.828||0.3741|TWO_SIDED|95.0|-85.32|32.19|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||32.19|-85.32|0.3741
91714455|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|6.16||0.0076||95.0|4.4|28.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.7|4.4|0.0076
91634644|NCT01401101|183161693|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED|95.0||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); used random effects to account for correlations wi/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.97
91634645|NCT01401101|183161694|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED|95.0|||||Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.54
91634646|NCT01401101|183161695|SUPERIORITY_OR_OTHER|||||||0.33||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); using random effects to control for correlations w/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.33
91634647|NCT01610414|183161696|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.|Vaccine efficacy|68.17|||<|0.0001|TWO_SIDED|95.0|55.56|77.53|||Poisson method|||Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.||77.53|55.56|<0.0001
91484647|NCT00866788|182843291|SUPERIORITY_OR_OTHER|||||||0.0473||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0473
91634648|NCT00472043|183161717|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||||<0.001
91634649|NCT04957745|183161729|OTHER||||||<|0.01||||||"Null hypothesis is that there is no difference in Percentage of Total Viewing Time that Peripheral Target is Perceived across visual confusion conditions."|ANOVA|||"Effect of visual confusion conditions (binocular, unilateral monocular, and bilateral monocular visual confusions) on Percentage of Total Viewing Time Peripheral Target is Perceived is analyzed by repeated measure (within-subject) ANOVA. The test was performed with a significance level of 0.05."||||<0.01
91667710|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.88|STANDARD_ERROR_OF_MEAN|30.091||0.4283|TWO_SIDED|95.0|-83.16|35.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.40|-83.16|0.4283
91714456|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|5.96||0.1257||95.0|-2.6|20.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.9|-2.6|0.1257
91484648|NCT00866788|182843292|SUPERIORITY_OR_OTHER|||||||0.164||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1640
91634650|NCT02608892|183161754|SUPERIORITY|Use of pain management during newborn screening was described using frequency and proportion and expressed as an absolute difference in proportions with 95% confidence interval.|Absolute difference in proportions|-7.4|||||TWO_SIDED|95.0|-26.2|11.5||||||||11.5|-26.2|
91634651|NCT00957723|183161762|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1 year, 2 year and 5 year||||<0.0001
91634652|NCT00957723|183161763|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1, 2, and 5 year||||<0.0001
91634653|NCT00957723|183161765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||SF36 Physical Component Score change from preop to 1 year||||<0.0001
91634654|NCT00957723|183161765|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||SF36 Mental Component Score change from preop to 1 year||||0.0002
91634655|NCT00957723|183161765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 2 years||||<0.0001
91634656|NCT00957723|183161765|SUPERIORITY_OR_OTHER|||||||0.0177|||||||Sign test|||SF36 Mental Component Score change from preop to 2 years||||0.0177
91667711|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.32|STANDARD_ERROR_OF_MEAN|30.458||0.0657|TWO_SIDED|95.0|-116.31|3.68|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||3.68|-116.31|0.0657
91634657|NCT00957723|183161765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 3 year||||<0.0001
91634658|NCT00957723|183161765|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Sign test|||SF36 Mental Component Score change from preop to 3 year||||0.0393
91634659|NCT00957723|183161765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 4 year||||<0.0001
91634660|NCT00957723|183161765|SUPERIORITY_OR_OTHER|||||||0.4905|||||||t-test, 2 sided|||SF36 Mental Component Score change from preop to 4 year||||0.4905
91634661|NCT00957723|183161765|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 5 year||||<0.0001
91634662|NCT00957723|183161765|SUPERIORITY_OR_OTHER|||||||0.0037|||||||Sign test|||SF36 Mental Component Score change from preop to 5 year||||0.0037
91667712|NCT01243151|183229310|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.26|STANDARD_ERROR_OF_MEAN|29.37||0.2586|TWO_SIDED|95.0|-91.11|24.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.60|-91.11|0.2586
91667713|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|STANDARD_ERROR_OF_MEAN|3.404||0.3326|TWO_SIDED|95.0|-3.49|10.14|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.14|-3.49|0.3326
91484649|NCT00866788|182843292|SUPERIORITY_OR_OTHER|||||||0.0005||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0005
91634663|NCT00957723|183161767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||LEAS score change from preop to 1, 2, 3, 4, and 5 years||||<0.0001
91634664|NCT00877890|183161780|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-0.94|-0.39|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is \<0; noninferiority if this upper limit is \<0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.||-0.39|-0.94|<.0001
91667714|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|3.69|STANDARD_ERROR_OF_MEAN|3.502||0.2967|TWO_SIDED|95.0|-3.32|10.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.70|-3.32|0.2967
91667715|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|3.466||0.8812|TWO_SIDED|95.0|-6.42|7.46|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-6.42|0.8812
91667716|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|3.433||0.3227|TWO_SIDED|95.0|-3.45|10.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.30|-3.45|0.3227
91667717|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|10.01|STANDARD_ERROR_OF_MEAN|4.221||0.021|TWO_SIDED|95.0|1.56|18.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.46|1.56|0.0210
91667718|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|4.326||0.1192|TWO_SIDED|95.0|-1.82|15.49|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.49|-1.82|0.1192
91634665|NCT00877890|183161781|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
91634666|NCT00877890|183161782|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
91667719|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|5.04|STANDARD_ERROR_OF_MEAN|4.367||0.2529|TWO_SIDED|95.0|-3.69|13.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.78|-3.69|0.2529
91667720|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|4.244||0.0725|TWO_SIDED|95.0|-0.73|16.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.25|-0.73|0.0725
91634667|NCT00877890|183161783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|5.57||0.0006|TWO_SIDED|95.0|-31.4|-9.5||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.5|-31.4|0.0006
91634668|NCT00877890|183161784|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.||||0.0008
91634669|NCT00877890|183161785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.487||0.0514|TWO_SIDED|95.0|-1.91|0.01|||ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||0.01|-1.91|0.0514
91634670|NCT00877890|183161786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.5||0.2367|TWO_SIDED|95.0|-4.7|1.2|||ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.||1.2|-4.7|0.2367
91634671|NCT00877890|183161787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7717|TWO_SIDED|95.0|-1.7|2.2|||ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.||2.2|-1.7|0.7717
91667721|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|3.214||0.0405|TWO_SIDED|95.0|0.3|13.18|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.18|0.30|0.0405
91667722|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|6.27|STANDARD_ERROR_OF_MEAN|3.258||0.0593|TWO_SIDED|95.0|-0.25|12.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.80|-0.25|0.0593
91667723|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|3.279||0.5936|TWO_SIDED|95.0|-4.81|8.33|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.33|-4.81|0.5936
91792558|NCT02129777|183462753|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|6.7||0.803|TWO_SIDED|95.0|-15.2|11.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||11.8|-15.2|0.803
91634672|NCT00877890|183161788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-22.9|-9.1|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-9.1|-22.9|<.0001
91634673|NCT00877890|183161789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.8||0.1251|TWO_SIDED|95.0|-2.8|0.3|||ANCOVA|||Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||0.3|-2.8|0.1251
91667724|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|9.78|STANDARD_ERROR_OF_MEAN|3.192||0.0034|TWO_SIDED|95.0|3.38|16.17|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.17|3.38|0.0034
91667725|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.428||0.0305|TWO_SIDED|95.0|0.74|14.46|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.46|0.74|0.0305
91484650|NCT00866788|182843292|SUPERIORITY_OR_OTHER|||||||0.0558||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0558
91634674|NCT00877890|183161790|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.043||0.2558|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2558
91634675|NCT04396106|183161798|OTHER|||||||0.721|||||||Cochran-Mantel-Haenszel|||||||0.721
91634676|NCT02698176|183161804|OTHER||Estimation of DLT Rate|0.25|||||TWO_SIDED|80.0|0.121|0.418|||||Point estimate and 2-sided 80% Bayesian credible interval for DLT rate estimated for the total number of participants from all 3 cohorts (CRPC+NMC+TNBC) that were evaluable for DLT analysis based on a non-informative prior distribution of Beta (1,1).|||0.418|0.121|
91634677|NCT02985684|183161823|OTHER|Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.|Binomial proportion|1.0|||<|0.0001|ONE_SIDED|95.0|0.974|||A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P \> 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1."|||0.974|<0.0001
91667726|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|5.41|STANDARD_ERROR_OF_MEAN|3.479||0.1252|TWO_SIDED|95.0|-1.55|12.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-1.55|0.1252
91667727|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|3.495||0.2923|TWO_SIDED|95.0|-3.28|10.71|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.71|-3.28|0.2923
91667728|NCT01243151|183229311|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.411||0.0297|TWO_SIDED|95.0|0.78|14.43|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.43|0.78|0.0297
91484651|NCT00866788|182843293|SUPERIORITY_OR_OTHER|||||||0.1411||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1411
91484652|NCT00866788|182843293|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
91484653|NCT00866788|182843293|SUPERIORITY_OR_OTHER|||||||0.0248||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0248
91667729|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.117|<|0.0001|TWO_SIDED|95.0|-34.59|-18.1|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.10|-34.59|<0.0001
91667730|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.29|STANDARD_ERROR_OF_MEAN|4.325|<|0.0001|TWO_SIDED|95.0|-32.95|-15.63|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-15.63|-32.95|<0.0001
91667731|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|STANDARD_ERROR_OF_MEAN|4.182|<|0.0001|TWO_SIDED|95.0|-39.58|-22.83|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.83|-39.58|<0.0001
91667732|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.43|STANDARD_ERROR_OF_MEAN|4.169|<|0.0001|TWO_SIDED|95.0|-38.78|-22.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.08|-38.78|<0.0001
91667733|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.3|STANDARD_ERROR_OF_MEAN|5.055|<|0.0001|TWO_SIDED|95.0|-43.42|-23.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.19|-43.42|<0.0001
91667734|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.14|STANDARD_ERROR_OF_MEAN|5.255|<|0.0001|TWO_SIDED|95.0|-44.65|-23.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.63|-44.65|<0.0001
91667735|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.57|STANDARD_ERROR_OF_MEAN|5.194|<|0.0001|TWO_SIDED|95.0|-52.96|-32.18|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.18|-52.96|<0.0001
91667736|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.87|STANDARD_ERROR_OF_MEAN|5.097|<|0.0001|TWO_SIDED|95.0|-52.07|-31.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.67|-52.07|<0.0001
91714457|NCT00676403|183320246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|5.95||0.0131||95.0|3.2|26.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.6|3.2|0.0131
91714458|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|6.94||0.1824||95.0|-23.0|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.0|0.1824
91714459|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.8||0.0767||95.0|-25.5|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-25.5|0.0767
91484654|NCT00866788|182843294|SUPERIORITY_OR_OTHER|||||||0.5507||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.5507
91634678|NCT02985684|183161824|OTHER|Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.|Binomial proportion|0.9|||<|0.0001|ONE_SIDED|95.0|0.843|||A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P \> 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1."|||0.843|<0.0001
91634679|NCT03479203|183161852|OTHER|T-Test followed by Bonferroni post-hoc analysis.|Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|1.5||0.05|TWO_SIDED|95.0|1.0|6.0|||t-test, 2 sided|||"Blood assessed for C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM), the high mobility group box-1 (HMGB1), the NLRP3 inflammasome, and nitrates (NOx for nitric oxide) pre- and post-vaping. CRP, sICAM HMGB1 and NLRP3 is in ng/ml blood and NOx is in nanomol/ml. These numbers were weighted to obtain an inflammation index in blood. This index represents the fold increase over pre-vaping values."||6|1|0.05
91634680|NCT03419741|183161861|OTHER|We plan to enroll 20 participants within one year. Eleven participants were enrolled. 11/20 = 55% completed the number of enrollment.|%|11.0|||||TWO_SIDED||||||percentage|||||||
91634681|NCT00836342|183161891|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.||||0.31
91634682|NCT00836342|183161892|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
91634683|NCT00836342|183161893|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
91634684|NCT04853368|183161909|SUPERIORITY||LS Mean of Difference|2.6|STANDARD_ERROR_OF_MEAN|0.84||0.002|TWO_SIDED|90.0|1.22|4.04||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.04|1.22|0.002
91634685|NCT04853368|183161909|SUPERIORITY||LS Mean of Difference|1.3|STANDARD_ERROR_OF_MEAN|1.92||0.254|TWO_SIDED|90.0|-2.07|4.67||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.67|-2.07|0.254
91634686|NCT04853368|183161909|SUPERIORITY||LS Mean of Difference|0.9||||0.402|TWO_SIDED|90.0|-5.07|6.77||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||6.77|-5.07|0.402
91634687|NCT04853368|183161911|SUPERIORITY||LS Mean of Difference|5.5|STANDARD_ERROR_OF_MEAN|2.63||0.022|TWO_SIDED|90.0|1.07|9.92||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||9.92|1.07|0.022
91634688|NCT04853368|183161911|SUPERIORITY||LS Mean of Difference|-14.1||||0.043|TWO_SIDED|90.0|-27.59|-0.62||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||-0.62|-27.59|0.043
91634689|NCT04853368|183161912|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.047||0.003|TWO_SIDED|90.0|0.059|0.219||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.219|0.059|0.003
91714460|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|7.11||0.0492||95.0|-28.1|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-28.1|0.0492
91484655|NCT00866788|182843294|SUPERIORITY_OR_OTHER|||||||0.1525||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1525
91484656|NCT00866788|182843294|SUPERIORITY_OR_OTHER|||||||0.0449||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0449
91484657|NCT00866788|182843295|SUPERIORITY_OR_OTHER|||||||0.7261||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.7261
91634690|NCT04853368|183161912|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.475|TWO_SIDED|90.0|-0.162|0.15||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.150|-0.162|0.475
91634691|NCT04853368|183161912|SUPERIORITY||LS Mean of Difference|-0.06||||0.352|TWO_SIDED|90.0|-0.332|0.212||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||Cohort 2: Difference between Triple Therapy and Placebo||0.212|-0.332|0.352
91714461|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|6.84||0.2023||95.0|-22.2|4.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-22.2|0.2023
91714462|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|6.83||0.0116||95.0|-30.9|-3.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.9|-30.9|0.0116
91714463|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|7.01||0.1819||95.0|-23.2|4.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.2|0.1819
91714464|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.76||0.2806||95.0|-20.6|6.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.0|-20.6|0.2806
91714465|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.13||0.1465||95.0|-24.4|3.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.4|0.1465
91714466|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.6|STANDARD_ERROR_OF_MEAN|6.85||0.0046||95.0|-33.1|-6.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.1|-33.1|0.0046
91634692|NCT04853368|183161913|SUPERIORITY||LS Mean of Difference|0.089|STANDARD_ERROR_OF_MEAN|0.0403||0.017|TWO_SIDED|90.0|0.0209|0.1568||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.1568|0.0209|0.017
91634693|NCT04853368|183161913|SUPERIORITY||LS Mean of Difference|0.103|STANDARD_ERROR_OF_MEAN|0.1033||0.169|TWO_SIDED|90.0|-0.1814|0.288||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.2880|-0.1814|0.169
91634694|NCT04853368|183161913|SUPERIORITY||Mean Difference (Final Values)|0.136||||0.23|TWO_SIDED|90.0|-0.1809|0.4527||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.4527|-0.1809|0.230
91634695|NCT04853368|183161914|SUPERIORITY||LS Mean of Difference|4.4||||0.002|TWO_SIDED|90.0|2.04|6.78||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.78|2.04|0.002
91634696|NCT04853368|183161914|SUPERIORITY||LS Mean of Difference|1.3||||0.35|TWO_SIDED|90.0|-4.42|6.97||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.97|-4.42|0.350
91634697|NCT04853368|183161914|SUPERIORITY||LS Mean of Difference|1.3||||0.412|TWO_SIDED|90.0|-8.75|11.34||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.34|-8.75|0.412
91634698|NCT04853368|183161915|SUPERIORITY||LS Mean of Difference|4.36|||<|0.001|TWO_SIDED|90.0|2.19|6.524||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.524|2.190|<0.001
91634699|NCT04853368|183161915|SUPERIORITY||LS Mean of Difference|-0.59||||0.396|TWO_SIDED|90.0|-4.449|3.268||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||3.268|-4.449|0.396
91634700|NCT04853368|183161915|SUPERIORITY||LS Mean of Difference|-2.0||||0.305|TWO_SIDED|90.0|-8.724|4.732||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||4.732|-8.724|0.305
91634701|NCT04853368|183161916|SUPERIORITY||LS Mean of Difference|6.475||||0.018|TWO_SIDED|90.0|1.4443|11.5056||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.5056|1.4443|0.018
91634702|NCT04853368|183161916|SUPERIORITY||LS Mean of Difference|6.019||||0.214|TWO_SIDED|90.0|-7.1464|19.1844||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.1844|-7.1464|0.214
91634703|NCT04853368|183161916|SUPERIORITY||LS Mean of Difference|7.29||||0.286|TWO_SIDED|90.0|-15.186|29.766||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||29.7660|-15.1860|0.286
91634704|NCT04853368|183161917|SUPERIORITY||LS Mean of Difference|5.6||||0.057|TWO_SIDED|90.0|-0.26|11.37||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.37|-0.26|0.057
91484658|NCT00866788|182843295|SUPERIORITY_OR_OTHER|||||||0.162||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.162
91667737|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.75|STANDARD_ERROR_OF_MEAN|4.343|<|0.0001|TWO_SIDED|95.0|-46.46|-29.05|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.05|-46.46|<0.0001
91667738|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.98|STANDARD_ERROR_OF_MEAN|4.519|<|0.0001|TWO_SIDED|95.0|-50.04|-31.93|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.93|-50.04|<0.0001
91667739|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.98|STANDARD_ERROR_OF_MEAN|4.441|<|0.0001|TWO_SIDED|95.0|-55.88|-38.08|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.08|-55.88|<0.0001
91667740|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.77|STANDARD_ERROR_OF_MEAN|4.363|<|0.0001|TWO_SIDED|95.0|-54.52|-37.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.03|-54.52|<0.0001
91667741|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.61|STANDARD_ERROR_OF_MEAN|4.616|<|0.0001|TWO_SIDED|95.0|-47.85|-29.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.37|-47.85|<0.0001
91667742|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.19|STANDARD_ERROR_OF_MEAN|4.795|<|0.0001|TWO_SIDED|95.0|-50.78|-31.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.60|-50.78|<0.0001
91667743|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.75|STANDARD_ERROR_OF_MEAN|4.722|<|0.0001|TWO_SIDED|95.0|-59.2|-40.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.30|-59.20|<0.0001
91667744|NCT01243151|183229312|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.04|STANDARD_ERROR_OF_MEAN|4.639|<|0.0001|TWO_SIDED|95.0|-57.33|-38.76|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.76|-57.33|<0.0001
91667745|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-31.06|-14.34|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-14.34|-31.06|<0.0001
91667746|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-27.17|-10.03|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-10.03|-27.17|<0.0001
91667747|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.97|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-36.46|-19.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-19.49|-36.46|<0.0001
91667748|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.89|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-33.24|-16.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-16.54|-33.24|<0.0001
91667749|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.89|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-37.25|-20.53|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.53|-37.25|<0.0001
91667750|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-34.92|-17.79|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.79|-34.92|<0.0001
91667751|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.89|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-44.46|-27.33|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.33|-44.46|<0.0001
91667752|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.23|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-42.58|-25.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.88|-42.58|<0.0001
91667753|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.96|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-42.39|-25.53|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.53|-42.39|<0.0001
91667754|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.41|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-43.98|-26.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.85|-43.98|<0.0001
91667755|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-51.85|-34.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.71|-51.85|<0.0001
91667756|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.0|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-46.35|-29.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.65|-46.35|<0.0001
91667757|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.77|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-38.19|-21.34|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-21.34|-38.19|<0.0001
91667758|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.22|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-39.79|-22.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.65|-39.79|<0.0001
91667759|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.34|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-49.91|-32.78|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.78|-49.91|<0.0001
91484659|NCT00866788|182843295|SUPERIORITY_OR_OTHER|||||||0.6504||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.6504
91667760|NCT01243151|183229313|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.04|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-44.39|-27.69|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.69|-44.39|<0.0001
91667761|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|3.975||0.269|TWO_SIDED|95.0|-3.53|12.41|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.41|-3.53|0.2690
91667762|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|5.22|STANDARD_ERROR_OF_MEAN|4.133||0.2122|TWO_SIDED|95.0|-3.07|13.5|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.50|-3.07|0.2122
91667763|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|4.054||0.8953|TWO_SIDED|95.0|-7.59|8.67|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.67|-7.59|0.8953
91667764|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|STANDARD_ERROR_OF_MEAN|4.045||0.1723|TWO_SIDED|95.0|-2.51|13.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.70|-2.51|0.1723
91667765|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|14.95|STANDARD_ERROR_OF_MEAN|4.293||0.001|TWO_SIDED|95.0|6.34|23.56|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.56|6.34|0.0010
91667766|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|10.86|STANDARD_ERROR_OF_MEAN|4.451||0.0179|TWO_SIDED|95.0|1.95|19.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.78|1.95|0.0179
91667767|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|4.44||0.0462|TWO_SIDED|95.0|0.16|17.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||17.96|0.16|0.0462
91667768|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|11.78|STANDARD_ERROR_OF_MEAN|4.358||0.0091|TWO_SIDED|95.0|3.05|20.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.52|3.05|0.0091
91714467|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|6.92||0.0187||95.0|-30.0|-2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-30.0|0.0187
91484660|NCT02349061|182843305|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0057|TWO_SIDED|95.0|1.41|7.63|||Regression, Logistic|||||7.63|1.41|0.0057
91484661|NCT02349061|182843306|SUPERIORITY||Least Squares (LS) Mean Difference|-1.36||||0.0929|TWO_SIDED|95.0|-2.94|0.23|||Mixed model repeated measures model|||||0.23|-2.94|0.0929
91484662|NCT02349061|182843307|SUPERIORITY||LS Means Difference|-0.383||||0.3944|TWO_SIDED|95.0|-1.271|0.506|||Mixed model repeated measures model|||||0.506|-1.271|0.3944
91484663|NCT02349061|182843308|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9939|TWO_SIDED|95.0|0.43|2.34|||Regression, Logistic|||||2.34|0.43|0.9939
91667769|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|7.31|STANDARD_ERROR_OF_MEAN|4.064||0.0774|TWO_SIDED|95.0|-0.83|15.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.45|-0.83|0.0774
91667770|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16|STANDARD_ERROR_OF_MEAN|4.165||0.0909|TWO_SIDED|95.0|-1.18|15.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.50|-1.18|0.0909
91667771|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|4.157||0.6107|TWO_SIDED|95.0|-6.2|10.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.45|-6.20|0.6107
91667772|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|11.59|STANDARD_ERROR_OF_MEAN|4.076||0.0062|TWO_SIDED|95.0|3.42|19.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.75|3.42|0.0062
91667773|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|8.69|STANDARD_ERROR_OF_MEAN|4.712||0.0702|TWO_SIDED|95.0|-0.74|18.13|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.13|-0.74|0.0702
91667774|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|6.69|STANDARD_ERROR_OF_MEAN|4.807||0.1692|TWO_SIDED|95.0|-2.93|16.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.32|-2.93|0.1692
91667775|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|4.819||0.3751|TWO_SIDED|95.0|-5.34|13.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.96|-5.34|0.3751
91714468|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|7.0||0.6128||95.0|-10.2|17.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-10.2|0.6128
91714469|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|6.76||0.3488||95.0|-19.7|7.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-19.7|0.3488
91714470|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.17||0.1472||95.0|-24.5|3.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.5|0.1472
91484664|NCT02349061|182843309|SUPERIORITY||LS Means Difference|-2.17||||0.1032|TWO_SIDED|95.0|-4.78|0.45|||Mixed model repeated measures model|||||0.45|-4.78|0.1032
91667776|NCT01243151|183229314|SUPERIORITY_OR_OTHER||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|4.709||0.0053|TWO_SIDED|95.0|4.23|23.08|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.08|4.23|0.0053
91667777|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.64|STANDARD_ERROR_OF_MEAN|3.951|<|0.0001|TWO_SIDED|95.0|-38.56|-22.72|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.72|-38.56|<0.0001
91667778|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.62|STANDARD_ERROR_OF_MEAN|4.084|<|0.0001|TWO_SIDED|95.0|-34.8|-18.44|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.44|-34.80|<0.0001
91667779|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.27|STANDARD_ERROR_OF_MEAN|4.003|<|0.0001|TWO_SIDED|95.0|-43.29|-27.24|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.24|-43.29|<0.0001
91484665|NCT02339285|182843321|OTHER|F-test; Treatment effect|||||>|0.1|||||||ANOVA|F(2, 29)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||>0.10
91484666|NCT02339285|182843321|OTHER|F-test; Session effect|||||<|0.001|||||||ANOVA|F(1, 31)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||<0.001
91634705|NCT04853368|183161917|SUPERIORITY||LS Mean of Difference|8.6||||0.088|TWO_SIDED|90.0|-2.18|19.4||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.40|-2.18|0.088
91634706|NCT04853368|183161917|SUPERIORITY||LS Mean of Difference|11.2||||0.142|TWO_SIDED|90.0|-6.9|29.25||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29.||||29.25|-6.90|0.142
91634707|NCT01722552|183161926|EQUIVALENCE|The margin for non-equivalence was 25 percentage points.|Risk Ratio (RR)|1.59|||<|0.05|TWO_SIDED|95.0|1.21|2.1|||Chi-squared|||The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.||2.1|1.21|<0.05
91634708|NCT00568399|183161927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_DEVIATION|0.987||0.001|TWO_SIDED|95.0||||Coronary calcium score after treatment compared to baseline|Wilcoxon (Mann-Whitney)|||This was a pilot study without a control group. There were no power calculations (see manuscript).||||0.001
91667780|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.42|STANDARD_ERROR_OF_MEAN|3.931|<|0.0001|TWO_SIDED|95.0|-41.3|-25.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.54|-41.30|<0.0001
91667781|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.38|STANDARD_ERROR_OF_MEAN|5.467|<|0.0001|TWO_SIDED|95.0|-52.34|-30.42|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-30.42|-52.34|<0.0001
91667782|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.12|STANDARD_ERROR_OF_MEAN|5.61|<|0.0001|TWO_SIDED|95.0|-49.36|-26.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.88|-49.36|<0.0001
91714471|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|6.89||0.0791||95.0|-25.7|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|-25.7|0.0791
91484667|NCT02339285|182843321|OTHER|F-test; Interaction effect (session x treatment)|||||>|0.1|||||||ANOVA|F(2,29)||||||>0.10
91484668|NCT02339285|182843322|OTHER|F-test; Condition effect|||||<|0.05|||||||ANOVA|F(2,21.595)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.05
91634709|NCT00724594|183161934|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.||||0.9
91634710|NCT00724594|183161934|OTHER|||||||0.9|||||||t-test, 2 sided|||Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort||||0.9
91634711|NCT00724594|183161935|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline||||0.9
91634712|NCT00724594|183161935|OTHER|||||||0.9|||||||t-test, 2 sided|||Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline||||0.9
91634713|NCT00724594|183161936|OTHER|||||||0.072|||||||t-test, 2 sided|||correcting for gestational age at birth||||0.072
91634714|NCT00724594|183161937|OTHER|||||||0.014|||||||t-test, 2 sided|||||||0.014
91634715|NCT00405756|183161942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.001|TWO_SIDED|95.0|0.278|0.56||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.560|0.278|<0.001
91634716|NCT00405756|183161942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|0.001|TWO_SIDED|95.0|0.347|0.702||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.702|0.347|<0.001
91634717|NCT00405756|183161942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.134|TWO_SIDED|95.0|0.589|1.075||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.075|0.589|0.134
91634718|NCT00405756|183161943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.214|0.541|||Log Rank|P-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.||||0.541|0.214|<0.001
91484669|NCT02339285|182843322|OTHER|F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal)|||||<|0.001|||||||ANOVA|F(3, 79.358)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.001
91634719|NCT00405756|183161945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.337|||<|0.001|TWO_SIDED|95.0|0.231|0.493||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.493|0.231|<0.001
91634720|NCT00405756|183161945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.414|||<|0.001|TWO_SIDED|95.0|0.284|0.603||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.603|0.284|<0.001
91634721|NCT00405756|183161945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.223|TWO_SIDED|95.0|0.606|1.125||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.125|0.606|0.223
91634722|NCT00405756|183161946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||<0.001
91792559|NCT02129777|183462753|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|6.73||0.248|TWO_SIDED|95.0|-5.7|21.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||21.4|-5.7|0.248
91484670|NCT02339285|182843322|OTHER|F-test; Interaction effect (region x condition)|||||>|0.1|||||||ANOVA|F(6, 68.284)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||>0.10
91792560|NCT02129777|183462753|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|6.67||0.914|TWO_SIDED|95.0|-12.7|14.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.2|-12.7|0.914
91792561|NCT02129777|183462753|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|6.74||0.523|TWO_SIDED|95.0|-9.2|17.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||17.9|-9.2|0.523
91792562|NCT02129777|183462754|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.37||0.978|TWO_SIDED|95.0|-2.7|2.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||2.8|-2.7|0.978
91484671|NCT02339285|182843323|OTHER||||||>|0.1|||||||ANOVA|||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups."||||>0.10
91484672|NCT02053051|182843328|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91525829|NCT02567825|182927166|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of routine non-illness visits at which a nonsusceptible pathogen is recovered.||1.41|0.84|
91792563|NCT02129777|183462754|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.36||0.389|TWO_SIDED|95.0|-3.9|1.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.5|-3.9|0.389
91792564|NCT02129777|183462754|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.39||0.316|TWO_SIDED|95.0|-4.2|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-4.2|0.316
91484673|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-3.18||||0.14|TWO_SIDED|95.0|-5.93|-0.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.43|-5.93|0.14
91634723|NCT00405756|183161946|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.009
91634724|NCT00405756|183161946|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.003
91634725|NCT00405756|183161946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.04|5.47|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||5.47|2.04|<0.001
91634726|NCT00405756|183161946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.096|TWO_SIDED|95.0|0.95|2.62|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||2.62|0.95|0.096
91634727|NCT00405756|183161946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.12||||0.002|TWO_SIDED|95.0|1.33|3.37|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||3.37|1.33|0.002
91634728|NCT00405756|183161948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.348|||<|0.001|TWO_SIDED|95.0|0.228|0.531||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.531|0.228|<0.001
91634729|NCT00405756|183161948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.419|||<|0.001|TWO_SIDED|95.0|0.281|0.623||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.623|0.281|<0.001
91634730|NCT00405756|183161948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.302|TWO_SIDED|95.0|0.571|1.191||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.191|0.571|0.302
91714472|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|6.97||0.0282||95.0|-29.1|-1.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.7|-29.1|0.0282
91634731|NCT00405756|183161949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.404|||<|0.001|TWO_SIDED|95.0|0.296|0.553||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.553|0.296|<0.001
91634732|NCT00405756|183161949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.499|||<|0.001|TWO_SIDED|95.0|0.363|0.688||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.688|0.363|<0.001
91634733|NCT00405756|183161949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.169|TWO_SIDED|95.0|0.63|1.085||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.085|0.630|0.169
91634734|NCT00286156|183161973|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Pairwise comparisons adjusted for multiple testing (Tukey)|ANOVA|||Null hypothesis: no difference between groups in iGFR||||<0.01
91634735|NCT01051856|183161992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
91634736|NCT02176226|183161994|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91634737|NCT02176226|183161995|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91634738|NCT03894501|183162012|SUPERIORITY|||||||0.048|||||||ANOVA|||||||.048
91634739|NCT03894501|183162013|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||.037
91634740|NCT03894501|183162014|SUPERIORITY|||||||0.024|||||||ANCOVA|||||||.024
91634741|NCT03894501|183162015|SUPERIORITY|||||||0.005|||||||ANCOVA|||||||.005
91634742|NCT03894501|183162016|SUPERIORITY|||||||0.013|||||||ANOVA|||||||.013
91634743|NCT03894501|183162017|SUPERIORITY|||||||0.035|||||||ANOVA|||||||.035
91634744|NCT01072500|183162018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.03|TWO_SIDED|95.0|0.69|0.98|||Regression, Cox|To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.||||0.98|0.69|0.03
91634745|NCT01072500|183162019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.006|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||||0.91|0.57|0.006
91634746|NCT01412333|183162033|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.532|||<|0.0001|TWO_SIDED|95.0|0.397|0.714|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.714|0.397|< 0.0001
91634747|NCT01412333|183162034|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.0169|TWO_SIDED|95.0|0.42|0.92|||Log Rank|||Time to onset of CDP at week 12||0.92|0.42|= 0.0169
91634748|NCT01412333|183162035|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.051|||<|0.0001||95.0|0.029|0.089|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.089|0.029|< 0.0001
91634749|NCT01412333|183162036|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.171|||<|0.0001||95.0|0.13|0.225|||Negative Binomial Model||Adjusted by baseline T2 lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.225|0.130|< 0.0001
91634750|NCT01412333|183162037|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.14|||=|0.4019|TWO_SIDED|95.0|0.84|1.56|||CMH Chi-Squared test (stratified)|Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||||1.56|0.84|= 0.4019
91634751|NCT01412333|183162038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.037|TWO_SIDED|95.0|0.4|0.98|||Log Rank|||Time to onset of CDP at week 24||0.98|0.40|= 0.037
91634752|NCT01412333|183162039|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.357|||<|0.0001||95.0|0.272|0.47|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.47|0.272|< 0.0001
91634753|NCT01412333|183162040|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.107|STANDARD_ERROR_OF_MEAN|0.037|=|0.004|TWO_SIDED|95.0|0.034|0.18|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.180|0.034|= 0.004
91634754|NCT01412333|183162041|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.112|STANDARD_ERROR_OF_MEAN|0.066|=|0.09|TWO_SIDED|95.0|-0.018|0.241|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.241|-0.018|= 0.09
91634755|NCT01412333|183162042|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|1.159|STANDARD_ERROR_OF_MEAN|0.564|=|0.0404|TWO_SIDED|95.0|0.051|2.268|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||2.268|0.051|= 0.0404
91634756|NCT01412333|183162043|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.81|||<|0.0001|TWO_SIDED|95.0|1.41|2.32|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.32|1.41|< 0.0001
91634757|NCT01038635|183162075|SUPERIORITY_OR_OTHER||Maximal tolerated dose|75.0|||||TWO_SIDED||||||||Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.|||||
91634758|NCT04542525|183162084|SUPERIORITY||||||<|0.0001|||||||Exact Test of Binomial Proportion||||P-value is provided from exact test of binomial proportion (one-sided alpha = 2.5%) comparing PanOptix Toric Trifocal IOL Model TFNT20 with historical threshold 29.2 % (rate calculated for a non-toric IOL in Japanese study patients that would qualify for a T2 lens using the same toric calculator).|||<0.0001
91634759|NCT01566981|183162184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6925|STANDARD_DEVIATION|1.4708||0.005|TWO_SIDED|95.0|0.2221|1.1629|||t-test, 2 sided|without adjustments, df=39||"Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05"||1.1629|0.2221|0.005
91634760|NCT01009333|183162197|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
91634761|NCT01009333|183162198|SUPERIORITY_OR_OTHER|||||||0.589||95.0|||||Mixed Models Analysis|||||||0.589
91634762|NCT01009333|183162199|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
91634763|NCT01012037|183162203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.97|-0.52|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-0.52|-0.97|<0.0001
91634764|NCT01012037|183162203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.02|-0.58|||ANCOVA|||Linagliptin 5mg qd versus Placebo||-0.58|-1.02|<0.0001
91634765|NCT01012037|183162203|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.07|0.19|||ANCOVA|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.19|-0.07|
91634766|NCT01012037|183162204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.83|-0.48|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.48|-0.83|<0.0001
91634767|NCT01012037|183162204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.84|-0.49|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.49|-0.84|<0.0001
91634768|NCT01012037|183162204|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.05||||95.0|-0.1|0.1|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.10|-0.10|
91634769|NCT01012037|183162205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.0|-0.54|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.54|-1.00|<0.0001
91634770|NCT01012037|183162205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.05|-0.59|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.59|-1.05|<0.0001
91634771|NCT01012037|183162205|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.08|0.18|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.18|-0.08|
91634772|NCT01012037|183162206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|4.6||0.0029||95.0|-22.7|-4.7|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-4.7|-22.7|0.0029
91634773|NCT01012037|183162206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|4.6||0.0001||95.0|-26.7|-8.8|||ANCOVA|||Linagliptin 5 mg qd versus Placebo||-8.8|-26.7|0.0001
91634774|NCT01012037|183162206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-1.0|9.2|||ANCOVA||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||9.2|-1.0|
91667783|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.42|STANDARD_ERROR_OF_MEAN|5.599|<|0.0001|TWO_SIDED|95.0|-58.64|-36.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.20|-58.64|<0.0001
91634775|NCT01012037|183162207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.6|STANDARD_ERROR_OF_MEAN|4.4||0.0002||95.0|-25.3|-7.8|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-7.8|-25.3|0.0002
91634776|NCT01012037|183162207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001||95.0|-27.6|-10.2|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-10.2|-27.6|<0.0001
91634777|NCT01012037|183162207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|2.5||||95.0|-2.6|7.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||7.3|-2.6|
91667784|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.93|STANDARD_ERROR_OF_MEAN|5.453|<|0.0001|TWO_SIDED|95.0|-57.87|-36.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.00|-57.87|<0.0001
91634778|NCT01012037|183162208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.4||0.0653||95.0|-20.6|0.6|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||0.6|-20.6|0.0653
91634779|NCT01012037|183162208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.4||0.0047||95.0|-25.8|-4.7|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-4.7|-25.8|0.0047
91634780|NCT01012037|183162208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.0||||95.0|-0.7|11.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||11.3|-0.7|
91634781|NCT02237898|183162217|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91634782|NCT01809327|183162228|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.657|-0.269|||Mixed Model for Repeated Measures (MMRM)|||||-0.269|-0.657|0.001
91634783|NCT01809327|183162228|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.67|-0.28|||Mixed Model for Repeated Measures (MMRM)|||||-0.280|-0.670|0.001
91634784|NCT01809327|183162228|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.594|-0.207|||Mixed Model for Repeated Measures (MMRM)|||||-0.207|-0.594|0.001
91634785|NCT01809327|183162228|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.557|-0.169|||Mixed Model for Repeated Measures (MMRM)|||||-0.169|-0.557|0.001
91634786|NCT01809327|183162228|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.258|0.133|||Mixed Model for Repeated Measures (MMRM)|||||0.133|-0.258|0.001
91634787|NCT01809327|183162228|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.307|0.082|||Mixed Model for Repeated Measures (MMRM)|||||0.082|-0.307|0.001
91634788|NCT01809327|183162229|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.016|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Model for Repeated Measures (MMRM)|||||-0.2|-1.6|0.016
91634789|NCT01809327|183162229|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.6|-1.1|||Mixed Model for Repeated Measures (MMRM)|||||-1.1|-2.6|0.002
91667785|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.37|STANDARD_ERROR_OF_MEAN|4.275|<|0.0001|TWO_SIDED|95.0|-53.96|-36.77|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.77|-53.96|<0.0001
91667786|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.78|STANDARD_ERROR_OF_MEAN|4.374|<|0.0001|TWO_SIDED|95.0|-57.58|-39.99|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.99|-57.58|<0.0001
91667787|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.49|STANDARD_ERROR_OF_MEAN|4.346|<|0.0001|TWO_SIDED|95.0|-63.23|-45.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.75|-63.23|<0.0001
91714473|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|7.08||0.1623||95.0|-23.9|4.0|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-23.9|0.1623
91527836|NCT06173570|182930689|SUPERIORITY||Mean Difference (Net)|-2.79||||0.146|TWO_SIDED|95.0|-6.56|0.98|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||0.98|-6.56|0.146
91634790|NCT01809327|183162229|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Model for Repeated Measures (MMRM)|||||-0.6|-2.1|0.001
91634791|NCT01809327|183162229|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Model for Repeated Measures (MMRM)|||||-1.4|-2.9|0.001
91634792|NCT01809327|183162230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.027|TWO_SIDED|95.0|1.06|2.37|||Generalized Linear Mixed Model|||||2.37|1.06|0.027
91634793|NCT01809327|183162230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.016|TWO_SIDED|95.0|1.46|3.33|||Generalized Linear Mixed Model|||||3.33|1.46|0.016
91634794|NCT01809327|183162231|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.882||0.06|TWO_SIDED|95.0|-3.641|-0.182|||Mixed Model for Repeated Measures (MMRM)|||||-0.182|-3.641|0.060
91634795|NCT01809327|183162231|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.889||0.147|TWO_SIDED|95.0|-3.058|0.431|||Mixed Model for Repeated Measures (MMRM)|||||0.431|-3.058|0.147
91667788|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.75|STANDARD_ERROR_OF_MEAN|4.222|<|0.0001|TWO_SIDED|95.0|-60.25|-43.26|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.26|-60.25|<0.0001
91667789|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.82|STANDARD_ERROR_OF_MEAN|4.373|<|0.0001|TWO_SIDED|95.0|-49.58|-32.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.07|-49.58|<0.0001
91667790|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.75|STANDARD_ERROR_OF_MEAN|4.464|<|0.0001|TWO_SIDED|95.0|-52.68|-34.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.81|-52.68|<0.0001
91667791|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.36|STANDARD_ERROR_OF_MEAN|4.437|<|0.0001|TWO_SIDED|95.0|-61.25|-43.48|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.48|-61.25|<0.0001
91634796|NCT01809327|183162232|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|1.2|9.5|||ANCOVA|||||9.5|1.2|0.147
91634797|NCT01809327|183162232|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|0.2|8.5|||ANCOVA|||||8.5|0.2|0.147
91634798|NCT01809327|183162233|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|-3.7||||0.608|TWO_SIDED|95.0|-11.1|3.4|||Wilcoxon (Mann-Whitney)|||||3.4|-11.1|0.608
91634799|NCT01809327|183162233|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|1.3||||0.806|TWO_SIDED|95.0|-7.3|10.0|||Wilcoxon (Mann-Whitney)|||||10.0|-7.3|0.806
91634800|NCT00852761|183162264|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
91634801|NCT00852761|183162264|SUPERIORITY_OR_OTHER|||||||1||||||This is the result for the Day 8 analysis.|Chi-squared|||||||1.0000
91667792|NCT01243151|183229315|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.94|STANDARD_ERROR_OF_MEAN|4.312|<|0.0001|TWO_SIDED|95.0|-58.58|-41.31|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.31|-58.58|<0.0001
91667793|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|19.581||0.9789|TWO_SIDED|95.0|-39.08|38.04|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||38.04|-39.08|0.9789
91634802|NCT00852761|183162265|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
91634803|NCT00852761|183162265|SUPERIORITY_OR_OTHER|||||||0.006||||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.0060
91634804|NCT00852761|183162265|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This is the result for the Day 15 analysis.|Chi-squared|||||||0.0060
91634805|NCT00852761|183162266|SUPERIORITY_OR_OTHER|||||||0.0332||||||Data apply to Day 15.|Chi-squared|||||||0.0332
91634806|NCT00852761|183162268|SUPERIORITY_OR_OTHER|||||||0.3101||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.3101
91634807|NCT00852761|183162268|SUPERIORITY_OR_OTHER|||||||0.7242||95.0||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.7242
91667794|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.94|STANDARD_ERROR_OF_MEAN|20.069||0.5525|TWO_SIDED|95.0|-51.46|27.59|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.59|-51.46|0.5525
91667795|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.39|STANDARD_ERROR_OF_MEAN|19.979||0.5035|TWO_SIDED|95.0|-52.73|25.96|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.96|-52.73|0.5035
91667796|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|19.601||0.8302|TWO_SIDED|95.0|-42.81|34.39|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||34.39|-42.81|0.8302
91714474|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|6.84||0.3739||95.0|-19.6|7.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-19.6|0.3739
91667797|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.45|STANDARD_ERROR_OF_MEAN|19.581||0.559|TWO_SIDED|95.0|-50.01|27.1|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.10|-50.01|0.5590
91634808|NCT00852761|183162268|SUPERIORITY_OR_OTHER|||||||0.0135||||||This is the p value for day 15|Chi-squared|||||||0.0135
91634809|NCT00852761|183162270|SUPERIORITY_OR_OTHER|||||||0.1449||||||P value at day 15.|Chi-squared|||||||0.1449
91634810|NCT00852761|183162270|SUPERIORITY_OR_OTHER|||||||0.1634||||||P value at day 3.|Chi-squared|||||||0.1634
91634811|NCT00852761|183162270|SUPERIORITY_OR_OTHER|||||||0.5454||||||P value at day 8.|Chi-squared|||||||0.5454
91634812|NCT00852761|183162271|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 15.|Chi-squared|||||||0.6715
91634813|NCT00852761|183162271|SUPERIORITY_OR_OTHER|||||||0.7242||||||This is the p value for day 8.|Chi-squared|||||||0.7242
91634814|NCT00852761|183162271|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 3.|Chi-squared|||||||0.6715
91634815|NCT00852761|183162272|SUPERIORITY_OR_OTHER|||||||0.4858||||||P value on day 8.|Chi-squared|||||||0.4858
91634816|NCT00852761|183162272|SUPERIORITY_OR_OTHER|||||||0.3001||||||P value on day 15.|Chi-squared|||||||0.3001
91634817|NCT01628718|183162313|NON_INFERIORITY|The NI margin for CAPS-IV scores was established a priori, based on a calculation of a reliable difference from baseline to posttreatment CAPS-IV scores from a previous trial (10 points). If the 95% confidence interval (CI) around the estimate does not contain the NI margin, we can reject the null hypothesis and accept the alternative hypothesis. .|Mean Difference (Final Values)|0.33||||0.05|TWO_SIDED|95.0|-10.1|9.44||one-tailed|Regression, Linear||Mean difference is the difference in mean CAPS-IV change scores (pre-post) between AD and CPT-C.|Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-C||9.44|-10.10|.05
91634818|NCT02140762|183162323|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|67.0|||<|0.0001|TWO_SIDED|95.0|65.0|69.0|||Generalized Linear Model||VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||69|65|<0.0001
91634819|NCT02140762|183162323|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|4.6|||||TWO_SIDED||||||Generalized Linear Model|||vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
91634820|NCT02140762|183162323|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|12.7|||||TWO_SIDED||||||generalized linear model.|||Vaccine effectiveness \<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
91634821|NCT02140762|183162323|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|18.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
91634822|NCT02140762|183162323|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|59.1|||||TWO_SIDED|||||||||Vaccine effectiveness \<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
91634823|NCT02140762|183162324|SUPERIORITY_OR_OTHER||Vaccine effectiveness|44.0|||<|0.0001|TWO_SIDED|95.0|41.0|47.0|||General Linear Model (GLM)||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.||47|41|< 0.0001
91634824|NCT02140762|183162324|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|9.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634825|NCT02140762|183162324|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|22.7|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634826|NCT02140762|183162324|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91667798|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.84|STANDARD_ERROR_OF_MEAN|20.069||0.5558|TWO_SIDED|95.0|-51.36|27.69|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.69|-51.36|0.5558
91667799|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|20.332||0.6835|TWO_SIDED|95.0|-48.34|31.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||31.74|-48.34|0.6835
91667800|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.15|STANDARD_ERROR_OF_MEAN|19.601||0.5699|TWO_SIDED|95.0|-49.75|27.45|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.45|-49.75|0.5699
91667801|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.42|STANDARD_ERROR_OF_MEAN|19.918||0.3826|TWO_SIDED|95.0|-56.64|21.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.80|-56.64|0.3826
91667802|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.83|STANDARD_ERROR_OF_MEAN|20.069||0.5233|TWO_SIDED|95.0|-52.35|26.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.70|-52.35|0.5233
91634827|NCT02140762|183162324|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|38.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634828|NCT02140762|183162325|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|46.0|||<|0.0001|TWO_SIDED|95.0|43.0|49.0|||Generalized Linear Model||VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is \>10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||49|43|<0.0001
91634829|NCT02140762|183162325|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|25.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634830|NCT02140762|183162325|OTHER|For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<30%||||
91634831|NCT02140762|183162325|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|10.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634832|NCT02140762|183162325|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|40.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634833|NCT02140762|183162326|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|20.0|||<|0.0001|TWO_SIDED|95.0|16.0|23.0||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|Generalized Linear Model||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||23|16|< 0.0001
91634834|NCT02140762|183162326|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|36.4|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91667803|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.47|STANDARD_ERROR_OF_MEAN|20.332||0.3391|TWO_SIDED|95.0|-59.51|20.57|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.57|-59.51|0.3391
91667804|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.95|STANDARD_ERROR_OF_MEAN|19.601||0.3606|TWO_SIDED|95.0|-56.55|20.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.65|-56.55|0.3606
91667805|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.33|STANDARD_ERROR_OF_MEAN|19.918||0.5364|TWO_SIDED|95.0|-51.55|26.89|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.89|-51.55|0.5364
91634835|NCT02140762|183162326|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|15.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634836|NCT02140762|183162326|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|20.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634837|NCT02140762|183162326|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|11.8|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
91634838|NCT01711359|183162354|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is \>-12%|Newcombe-Wilson method|14.8|||||TWO_SIDED|95.0|5.5|24.1|||||Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).|||24.1|5.5|
91634839|NCT01385098|183162376|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91634840|NCT01385098|183162377|SUPERIORITY_OR_OTHER|||||||0.013||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.013
91667806|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.56|STANDARD_ERROR_OF_MEAN|20.069||0.5651|TWO_SIDED|95.0|-51.08|27.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.96|-51.08|0.5651
91667807|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.65|STANDARD_ERROR_OF_MEAN|20.332||0.4719|TWO_SIDED|95.0|-54.69|25.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.39|-54.69|0.4719
91714475|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|7.26||0.0517||95.0|-28.5|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-28.5|0.0517
91484674|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.79|TWO_SIDED|95.0|-3.75|1.49||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.49|-3.75|0.79
91634841|NCT01385098|183162377|SUPERIORITY_OR_OTHER|||||||0.01||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.010
91634842|NCT01138995|183162398|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher's combination test|Between group difference for entire sample||||||0.75
91634843|NCT01138995|183162399|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.022
91634844|NCT01138995|183162400|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91634845|NCT00784225|183162404|SUPERIORITY||Cox Proportional Hazard|0.75||||0.52|TWO_SIDED|95.0|0.32|1.79|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for selenium||1.79|0.32|0.52
91634846|NCT00784225|183162404|SUPERIORITY||Cox Proportional Hazard|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for vitamin E||1.77|0.31|0.51
91634847|NCT00784225|183162405|SUPERIORITY||Cox Proportional Hazard|0.91||||0.37|TWO_SIDED|95.0|0.75|1.11|||Regression, Cox|||||1.11|0.75|0.37
91634848|NCT00784225|183162405|SUPERIORITY||Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.84|1.25|||Regression, Cox|||||1.25|0.84|0.81
91634849|NCT00784225|183162406|SUPERIORITY||Cox Proportional Hazard|2.5||||0.12|TWO_SIDED|95.0|0.79|7.98|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for selenium||7.98|0.79|0.12
91634850|NCT00784225|183162406|SUPERIORITY||Cox Proportional Hazard|0.99||||0.98|TWO_SIDED|95.0|0.35|2.82|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for vitamin E||2.82|0.35|0.98
91634851|NCT00784225|183162407|SUPERIORITY||Cox Proportional Hazard|0.84||||0.19|TWO_SIDED|95.0|0.64|1.09|||Regression, Cox|||||1.09|0.64|0.19
91634852|NCT00784225|183162407|SUPERIORITY||Cox Proportional Hazard|1.08||||0.58|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||||1.41|0.83|0.58
91634853|NCT02551874|183162408|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<0.3%|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.085||0.118|TWO_SIDED|95.0|-0.3|0.03||Superiority|Mixed Models Analysis|Adjusted for treatment, baseline HbA1c, randomization stratification factor, visit, treatment-by-visit, and baseline HbA1c-by-visit.||||0.03|-0.30|0.118
91634854|NCT02551874|183162409|SUPERIORITY||Mean Difference (Final Values)|-3.64|STANDARD_ERROR_OF_MEAN|0.282|<|0.001|TWO_SIDED|95.0|-4.2|-3.09|||Mixed Models Analysis|Adjusted for treatment, baseline body weight, randomization stratification factor, visit, treatment-by-visit, and baseline body weight-by-visit.||||-3.09|-4.20|<0.001
91634855|NCT02551874|183162410|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.62|||Regression, Logistic|Adjusted for baseline HbA1c and randomization stratification factor (background medication of metformin with or without SU).||||0.62|0.30|<0.001
91634856|NCT02551874|183162411|SUPERIORITY||Odds Ratio (OR)|1.8||||0.008|TWO_SIDED|95.0|1.16|2.67|||Regression, Logistic|||||2.67|1.16|0.008
91634857|NCT02551874|183162412|NON_INFERIORITY|Noninferiority was defined by lower bound of 95% CI \>-10%.|Adjusted Percent Difference|-0.4|||||TWO_SIDED|95.0|-7.42|6.54||||||||6.54|-7.42|
91667808|NCT01243151|183229316|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.53|STANDARD_ERROR_OF_MEAN|19.601||0.3999|TWO_SIDED|95.0|-55.13|22.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||22.07|-55.13|0.3999
91667809|NCT01579006|183229381|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667810|NCT01579006|183229382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667811|NCT01579006|183229383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91484675|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-4.79|||<|0.01|TWO_SIDED|95.0|-7.35|-2.24||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-2.24|-7.35|<0.01
91667812|NCT01579006|183229385|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667813|NCT01579006|183229386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667814|NCT01579006|183229392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667815|NCT01579006|183229393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91634858|NCT02551874|183162413|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<12 mg/dL.|Mean Difference (Final Values)|-19.99|STANDARD_ERROR_OF_MEAN|3.55|<|0.0001|TWO_SIDED|95.0|-26.98|-13.0|||Mixed Models Analysis|Adjusted for treatment, baseline measurement, randomization stratification factor, visit, treatment-by-visit, and baseline-by-visit.||||-13.00|-26.98|<0.0001
91634859|NCT02528643|183162429|SUPERIORITY||Hazard Ratio (HR)|1.146||||0.248|TWO_SIDED|95.0|0.774|1.696||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by geographic region and ECOG performance status. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.696|0.774|0.248
91634860|NCT02528643|183162429|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.252|TWO_SIDED|95.0|0.773|1.688||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.688|0.773|0.252
91634861|NCT02528643|183162434|SUPERIORITY||Hazard Ratio (HR)|1.039||||0.396|TWO_SIDED|95.0|0.732|1.474||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by ECOG performance status and region. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.474|0.732|0.396
91634862|NCT02528643|183162434|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.586|TWO_SIDED|95.0|0.684|1.345||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.345|0.684|0.586
91634863|NCT02058940|183162449|OTHER|||||||0.2|||||||Spearman's Correlation Coefficient|||||||0.2
91667816|NCT01579006|183229394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667817|NCT01579006|183229395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667818|NCT01579006|183229396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667819|NCT01579006|183229398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
91667820|NCT00799708|183229405|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||||||0.345
91667821|NCT00799708|183229405|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||ANOVA|||||||0.166
91667822|NCT00799708|183229406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.12|TWO_SIDED|90.0|-0.16|0.92|||ANCOVA|||||0.92|-0.16|0.120
91667823|NCT01192776|183229426|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.76|1.98||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.98|0.76|
91667824|NCT01192776|183229426|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.78|1.87||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.87|0.78|
91634864|NCT01192139|183162541|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin|Ratio of Geometric Least Squares Means|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.068|1.011|
91634865|NCT01192139|183162541|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Means|1.078|||||TWO_SIDED|90.0|1.049|1.108|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.108|1.049|
91634866|NCT01192139|183162541|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|104.65||||||95.0||||||||Geometric least squares means for treatment A||||
91634867|NCT01192139|183162541|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|108.74||||||95.0||||||||Geometric least squares means for treatment B||||
91634868|NCT01192139|183162541|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|100.84||||||95.0||||||||Geometric least squares mean for treatment C||||
91634869|NCT01192139|183162543|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.068|1.011|
91634870|NCT01192139|183162543|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|1.051|1.11|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.110|1.051|
91634871|NCT01192139|183162543|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|102.84||||||95.0||||||||Geometric least squares mean for treatment A||||
91634872|NCT01192139|183162543|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|106.89||||||95.0||||||||Geometric least squares mean for treatment B||||
91634873|NCT01192139|183162543|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|98.99||||||95.0||||||||Geometric least squares mean for treatment C||||
91634874|NCT01192139|183162544|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of Geometric Least Squares Means|1.021|||||TWO_SIDED|90.0|0.94|1.109|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.109|0.940|
91634875|NCT01192139|183162544|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the fed to fasted ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin.|Ratio of Geometric Least Squares Means|0.949|||||TWO_SIDED|90.0|0.873|1.031|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.031|0.873|
91634876|NCT01192139|183162544|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|25.68||||||95.0||||||||Geometric least squares mean for treatment A||||
91634877|NCT01192139|183162544|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|26.21||||||95.0||||||||Geometric least squares mean for treatment B||||
91667825|NCT01192776|183229426|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.53|1.35||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.53|
91667826|NCT01192776|183229427|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.16|||||TWO_SIDED|95.0|0.55|8.49||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||8.49|0.55|
91667827|NCT01192776|183229427|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|1.06|5.95||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||5.95|1.06|
91667828|NCT01192776|183229427|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.79|4.31||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||4.31|0.79|
91634878|NCT01192139|183162544|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|27.63||||||95.0||||||||Geometric least squares mean for treatment C||||
91634879|NCT01192139|183162553|NON_INFERIORITY_OR_EQUIVALENCE|BE concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Geometric Means|0.915|||||TWO_SIDED|90.0|0.836|1.002|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.002|0.836|
91634880|NCT01192139|183162553|NON_INFERIORITY_OR_EQUIVALENCE|lack of food effect concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Geometric LS Mean and 90% CI|1.01|||||TWO_SIDED|90.0|0.918|1.111|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.111|0.918|
91634881|NCT01192139|183162553|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5542.2||||||95.0||||||||Geometric least squares means for treatment A||||
91634882|NCT01192139|183162553|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5072.9||||||95.0||||||||Geometric least squares mean for treatment B||||
91634883|NCT01192139|183162553|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5023.3||||||95.0||||||||Geometric least squares mean for treatment C||||
91634884|NCT01192139|183162554|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|0.92|||||TWO_SIDED|90.0|0.854|0.992|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.992|0.854|
91634885|NCT01192139|183162554|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.025|||||TWO_SIDED|95.0|0.951|1.105|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.105|0.951|
91634886|NCT01192139|183162554|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5287.1||||||95.0||||||||Geometric least squares means for treatment A||||
91634887|NCT01192139|183162554|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4866.2||||||95.0||||||||Geometric least squares mean for treatment B||||
91634888|NCT01192139|183162554|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4746.8||||||95.0||||||||Geometric least squares means for treatment C||||
91634889|NCT01192139|183162555|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|Ratio of Geometric Least Squares Means|0.933|||||TWO_SIDED|95.0|0.865|1.007|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.007|0.865|
91634890|NCT01192139|183162555|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(inf) of saxagliptin and metformin.|Ratio of Geometric Least Squares Means|0.898|||||TWO_SIDED|90.0|0.832|0.969|||||Ration = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||0.969|0.832|
91634891|NCT01192139|183162555|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|608.41||||||95.0||||||||Geometric least squares mean for treatment A||||
91634892|NCT01192139|183162555|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|567.85||||||95.0||||||||Geometric least squares mean for treatment B||||
91634893|NCT01192139|183162555|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|632.39||||||95.0||||||||Geometric least squares mean for treatment C||||
91634894|NCT03287960|183162561|OTHER|Two-sided confidence interval obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest will achieve 10% weight loss.||||||0.0001|||||||Clopper-Pearson method|||||||0.0001
91634895|NCT03287960|183162562|OTHER|Two-sided confidence interval (CI) obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of patients in the population of interest would achieve 10% weight loss.|||||<|0.0001|||||||Clopper-Pearson method|||||||<0.0001
91634896|NCT03287960|183162563|OTHER|Model based summary statistics from longitudinal mixed analysis of variance (ANOVA) model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.|Least Squares Mean|-12.37|||<|0.0001|TWO_SIDED|90.0|-15.08|-9.66|||ANOVA|Longitudinal mixed ANOVA||||-9.66|-15.08|<.0001
91667829|NCT01192776|183229432|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.64|2.38||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.38|0.64|
91484676|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-3.76||||0.04|TWO_SIDED|95.0|-6.37|-1.15|||Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-1.15|-6.37|0.04
91634897|NCT03287960|183162564|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.|Least Squares Mean|-42.69|||<|0.0001|TWO_SIDED|90.0|-56.35|-29.02|||ANOVA|Longitudinal mixed analysis of variance (ANOVA) model||||-29.02|-56.35|<.0001
91667830|NCT01192776|183229432|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.36|1.9||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.90|0.36|
91484677|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.72|TWO_SIDED|95.0|-5.04|0.95||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.95|-5.04|0.72
91634898|NCT03287960|183162565|OTHER|Two-sided CI obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that ≥5 % of participants in the population of interest would achieve ≥25 % improvement in daily hunger score.|||||<|0.0001|||||||Clopper-Pearson method|||||||<.0001
91634899|NCT03287960|183162566|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.|Least Squares Mean|-8.9||||0.0031|TWO_SIDED|90.0|-14.1|-3.61|||ANOVA|Longitudinal mixed ANOVA||||-3.61|-14.10|0.0031
91634900|NCT03287960|183162569|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.|Least Squares Mean|-14.0|||<|0.0001|TWO_SIDED|90.0|-16.8|-11.2|||ANOVA|Longitudinal mixed ANOVA model||||-11.20|-16.80|<.0001
91634901|NCT00656136|183162581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.077||||0.7428|TWO_SIDED|95.0|0.862|1.346||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.||1.346|0.862|0.7428
91634902|NCT00656136|183162581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.3955|TWO_SIDED|95.0|0.814|1.17||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.||1.170|0.814|0.3955
91634903|NCT00656136|183162582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.306|0.475||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||0.475|0.306|<0.0001
91634904|NCT00656136|183162583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.61||||0.0071|TWO_SIDED|95.0|2.1|115.0||P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)|Regression, Logistic|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||115|2.1|0.0071
91634905|NCT00266799|183162605|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.08||||0.6686|TWO_SIDED|95.0|0.76|1.54|||Log Rank|||By Investigator Assessment of ITT Population||1.54|0.76|0.6686
91634906|NCT00266799|183162605|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.15||||0.4472|TWO_SIDED|95.0|0.8|1.65|||Log Rank|||By RECIST Criteria of ITT Population||1.65|0.80|0.4472
91634907|NCT00266799|183162605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5508|TWO_SIDED|95.0|0.74|1.77|||Log Rank|||By Investigator Assessment of TTP Population||1.77|0.74|0.5508
91634908|NCT00266799|183162605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.4088|TWO_SIDED|95.0|0.77|1.89|||Log Rank|||By RECIST Criteria of TTP Population||1.89|0.77|0.4088
91634909|NCT00266799|183162606|SUPERIORITY_OR_OTHER|||||||0.1726||95.0|||||Chi-squared|||By Investigator Assessment||||0.1726
91634910|NCT00266799|183162606|SUPERIORITY_OR_OTHER|||||||0.6541||95.0|||||Chi-squared|||By RECIST Criteria||||0.6541
91634911|NCT00266799|183162607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.5265|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||||1.58|0.79|0.5265
91634912|NCT00266799|183162608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0841||95.0|||||Log Rank|p-value also given for Hazard Ratio||||||0.0841
91634913|NCT02607865|183162610|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
91634914|NCT02607865|183162610|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
91667831|NCT01192776|183229432|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.26|1.57||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.57|0.26|
91667832|NCT01192776|183229434|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.63|2.77||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.77|0.63|
91667833|NCT01192776|183229434|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.42|||||TWO_SIDED|95.0|0.09|2.04||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.04|0.09|
91667834|NCT01192776|183229434|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.2|2.99||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.99|0.20|
91667835|NCT01192776|183229435|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.14|3.01||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.01|0.14|
91667836|NCT01192776|183229435|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.44|3.91||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.91|0.44|
91667837|NCT01192776|183229435|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.28|||||TWO_SIDED|95.0|0.03|2.89||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.89|0.03|
91667838|NCT01192776|183229436|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.37|2.07||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.07|0.37|
91667839|NCT01192776|183229436|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.35||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.30|
91667840|NCT01192776|183229436|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.13|1.64||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.64|0.13|
91667841|NCT01586039|183229454|SUPERIORITY|||||||0.73||||||Contrasting LED vs. CFL at 90 lux intensity|t-test, 2 sided|Paired t-test.||Contrasting LED vs. CFL at 90 lux intensity. Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. Higher values indicate more light-induced melatonin suppression.||||0.73
91667842|NCT01586039|183229454|SUPERIORITY|||||||0.001||||||Contrasting LED vs. CFL at 50 lux intensity|t-test, 2 sided|Paired t-test||Contrasting LED vs. CFL at 50 lux intensity||||0.001
91667843|NCT01586039|183229455|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Paired t-test||||||0.19
91667844|NCT01586039|183229457|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|Paired t-test.||||||0.17
91667845|NCT01586039|183229457|SUPERIORITY|||||||1|||||||t-test, 2 sided|Paired test.||||||1.0
91667846|NCT01943435|183229464|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|0.3||||0.73|TWO_SIDED|95.0|-1.5|2.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||2.2|-1.5|0.73
91667847|NCT01943435|183229464|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|-2.1||||0.02|TWO_SIDED|95.0|-3.9|-0.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||-0.3|-3.9|0.02
91667848|NCT01943435|183229464|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|2.4||||0.01|TWO_SIDED|95.0|0.6|4.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||4.3|0.6|0.01
91667849|NCT01943435|183229465|SUPERIORITY||Mean Difference (Final Values)|87.0||||0.29|TWO_SIDED|95.0|-75.2|249.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||249.2|-75.2|0.29
91667850|NCT01943435|183229465|SUPERIORITY||Mean Difference (Final Values)|129.7||||0.1|TWO_SIDED|95.0|-27.2|286.6|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||286.6|-27.2|0.10
91667851|NCT01943435|183229465|SUPERIORITY||Mean Difference (Final Values)|-42.7||||0.61|TWO_SIDED|95.0|-205.4|120.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||120.0|-205.4|0.61
91667852|NCT01943435|183229466|SUPERIORITY||Mean Difference (Final Values)|30.5||||0.03|TWO_SIDED|95.0|3.1|57.9|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||57.9|3.1|0.03
91792565|NCT02129777|183462754|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.41||0.142|TWO_SIDED|95.0|-4.9|0.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.7|-4.9|0.142
91634915|NCT02607865|183162610|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
91634916|NCT02607865|183162610|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
91634917|NCT02607865|183162610|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|0.2|||=|0.0856|TWO_SIDED|95.0|0.1|0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.1|= 0.0856
91667853|NCT01943435|183229466|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.16|TWO_SIDED|95.0|-7.6|45.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||45.0|-7.6|0.16
91667854|NCT01943435|183229466|SUPERIORITY||Mean Difference (Final Values)|11.8||||0.4|TWO_SIDED|95.0|-15.6|39.1|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||39.1|-15.6|0.40
91667855|NCT04535986|183229469|SUPERIORITY||LS mean difference|0.0868|STANDARD_ERROR_OF_MEAN|0.0162|<|0.0001|TWO_SIDED|95.0|0.0551|0.1185||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1185|0.0551|<0.0001
91667856|NCT01632215|183229486|SUPERIORITY||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
91667857|NCT04561115|183229499|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.948|||||TWO_SIDED|90.0|0.926|0.972||||||||0.972|0.926|
91667858|NCT04561115|183229500|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.978|||||TWO_SIDED|90.0|0.937|1.021||||||||1.021|0.937|
91667859|NCT00784095|183229556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.047|TWO_SIDED|95.0|0.04|5.7|||Mixed Models Analysis|||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.7|.04|.047
91667860|NCT00784095|183229556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|||||TWO_SIDED|95.0|-1.1|4.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||4.7|-1.1|
91667861|NCT00784095|183229557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-3.2|5.6||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.6|-3.2|
91667862|NCT00784095|183229557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.6|3.3||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||3.3|-5.6|
91667863|NCT00784095|183229558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-6.2|2.9||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||2.9|-6.2|
91667864|NCT00784095|183229558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-8.2|1.0||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||1.0|-8.2|
91634918|NCT02607865|183162610|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|0.2|||=|0.008|TWO_SIDED|95.0|0.0|0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.0|= 0.0080
91634919|NCT02607865|183162610|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
91634920|NCT02607865|183162610|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
91634921|NCT02607865|183162610|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
91634922|NCT02607865|183162610|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
91667865|NCT00784095|183229559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.5|3.4||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.4|-4.5|
91667866|NCT00784095|183229559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.1|3.0||||||Intervention versus Attention Control at 8 weeks.||3.0|-5.1|
91667867|NCT00784095|183229560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.8|3.7||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.7|-4.8|
91667868|NCT00784095|183229560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-1.9|6.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks.||6.7|-1.9|
91667869|NCT01874535|183229561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.009|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91667870|NCT02616380|183229563|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
91667871|NCT02616380|183229564|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
91667872|NCT02616380|183229564|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
91667873|NCT02616380|183229564|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||<0.0001
91667874|NCT02616380|183229564|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
91667875|NCT02616380|183229565|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
91667876|NCT02616380|183229565|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
91484678|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.8|TWO_SIDED|95.0|-3.18|2.46||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.46|-3.18|0.80
91634923|NCT02607865|183162610|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||=|0.3851|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|=0.3851
91634924|NCT02607865|183162610|OTHER|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|<0.0001
91634925|NCT02607865|183162611|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.0|-3.0|< 0.0001
91634926|NCT02607865|183162611|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-2.0|< 0.0001
91634927|NCT02607865|183162611|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||=|0.0185|TWO_SIDED|95.0|-1.1|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-1.1|= 0.0185
91667877|NCT02616380|183229566|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||<0.0001
91667878|NCT02616380|183229566|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||<0.0001
91667879|NCT02616380|183229566|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
91667880|NCT02616380|183229566|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
91667881|NCT02616380|183229567|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
91667882|NCT01929681|183229591|SUPERIORITY||||||<|0.049|||||||Regression, Linear|||||||<0.049
91667883|NCT01929681|183229592|SUPERIORITY||||||<|0.182|||||||Regression, Linear|||||||<0.182
91667884|NCT01929681|183229593|SUPERIORITY||||||<|0.449|||||||Regression, Linear|Mixed effects analysis||||||<0.449
91667885|NCT01929681|183229594|SUPERIORITY||||||<|0.444|||||||Regression, Linear|Mixed effects analysis||||||<0.444
91667886|NCT01929681|183229595|SUPERIORITY||||||<|0.182|||||||Regression, Linear|Mixed effects analysis||||||<0.182
91667887|NCT00421304|183229606|SUPERIORITY|||||||0.218|||||||Wilcoxon's rank-sum test|||||||0.218
91667888|NCT00421304|183229606|SUPERIORITY|||||||0.643|||||||Wilcoxon's rank-sum test|||||||0.643
91714476|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.92||0.0815||95.0|-25.8|1.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.5|-25.8|0.0815
91714477|NCT00676403|183320247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|7.0||0.0031||95.0|-34.7|-7.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.1|-34.7|0.0031
91667889|NCT00421304|183229606|SUPERIORITY|||||||0.677|||||||Wilcoxon's rank-sum test|||||||0.677
91714478|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.88||0.3368||95.0|-8.0|23.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.1|-8.0|0.3368
91667890|NCT00421304|183229607|SUPERIORITY|||||||0.257|||||||Wilcoxon's rank-sum test|||||||0.257
91714479|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.2|STANDARD_ERROR_OF_MEAN|7.75||0.4232||95.0|-21.5|9.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.1|-21.5|0.4232
91714480|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|8.09||0.7082||95.0|-12.9|19.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-12.9|0.7082
91714481|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|7.7||0.9466||95.0|-15.7|14.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.7|-15.7|0.9466
91714482|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|7.72||0.3746||95.0|-22.1|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-22.1|0.3746
91484679|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-3.12||||0.14|TWO_SIDED|95.0|-5.97|-0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.44|-5.97|0.14
91525830|NCT02567825|182927167|SUPERIORITY|The analysis was ITT. The participants are randomized children with at least one episode of AOM late during the respiratory season at which a nasopharyngeal or throat culture is obtained.|Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.69|1.95|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|||1.95|0.69|
91667891|NCT00421304|183229607|SUPERIORITY|||||||0.726|||||||Wilcoxon's rank-sum test|||||||0.726
91667892|NCT00421304|183229607|SUPERIORITY|||||||0.551|||||||Wilcoxon's rank-sum test|||||||0.551
91667893|NCT00421304|183229608|SUPERIORITY|||||||0.591|||||||Wilcoxon's rank-sum test|||||||0.591
91667894|NCT00421304|183229608|SUPERIORITY|||||||0.393|||||||Wilcoxon's rank-sum test|||||||0.393
91667895|NCT00421304|183229608|SUPERIORITY|||||||0.586|||||||Wilcoxon's rank-sum test|||||||0.586
91667896|NCT00421304|183229609|SUPERIORITY|||||||0.894|||||||Wilcoxon's rank-sum test|||||||0.894
91667897|NCT00421304|183229609|SUPERIORITY|||||||0.674|||||||Wilcoxon's rank-sum test|||||||0.674
91667898|NCT00421304|183229609|SUPERIORITY|||||||0.636|||||||Wilcoxon's rank-sum test|||||||0.636
91667899|NCT00421304|183229610|SUPERIORITY|||||||0.397|||||||Wilcoxon's rank-sum test|||||||0.397
91667900|NCT00421304|183229610|SUPERIORITY|||||||0.238|||||||Wilcoxon's rank-sum test|||||||0.238
91667901|NCT00421304|183229610|SUPERIORITY|||||||0.461|||||||Wilcoxon's rank-sum test|||||||0.461
91667902|NCT00421304|183229611|SUPERIORITY|||||||0.322|||||||Wilcoxon's rank-sum test|||||||0.322
91667903|NCT00421304|183229611|SUPERIORITY|||||||0.747|||||||Wilcoxon's rank-sum test|||||||0.747
91667904|NCT00421304|183229611|SUPERIORITY|||||||0.717|||||||Wilcoxon's rank-sum test|||||||0.717
91667905|NCT00421304|183229612|SUPERIORITY|||||||0.847|||||||Wilcoxon's rank-sum test|||||||0.847
91667906|NCT00421304|183229612|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
91667907|NCT00421304|183229612|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
91667908|NCT00421304|183229613|SUPERIORITY|||||||0.653|||||||Wilcoxon's rank-sum test|||||||0.653
91634928|NCT02607865|183162611|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-2.1|-3.1|<0.0001
91634929|NCT02607865|183162611|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.1|-2.0|<0.0001
91634930|NCT02607865|183162611|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|type Mean treatment difference|-0.5|||=|0.0257|TWO_SIDED|95.0|-1.0|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-1.0|=0.0257
91634931|NCT02607865|183162632|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.34|||=|0.0063|TWO_SIDED|95.0|1.09|1.65||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.65|1.09|=0.0063
91667909|NCT00421304|183229613|SUPERIORITY|||||||0.283|||||||Wilcoxon's rank-sum test|||||||0.283
91667910|NCT00421304|183229613|SUPERIORITY|||||||0.411|||||||Wilcoxon's rank-sum test|||||||0.411
91667911|NCT00421304|183229614|SUPERIORITY|||||||0.988|||||||Wilcoxon's rank-sum test|||||||0.988
91667912|NCT00421304|183229614|SUPERIORITY|||||||0.832|||||||Wilcoxon's rank-sum test|||||||0.832
91667913|NCT00421304|183229614|SUPERIORITY|||||||0.748|||||||Wilcoxon's rank-sum test|||||||0.748
91667914|NCT00421304|183229615|SUPERIORITY|||||||0.28|||||||Wilcoxon's rank-sum test|||||||0.280
91667915|NCT00421304|183229615|SUPERIORITY|||||||0.108|||||||Wilcoxon's rank-sum test|||||||0.108
91667916|NCT00421304|183229615|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
91667917|NCT00421304|183229616|SUPERIORITY|||||||0.742|||||||Wilcoxon's rank-sum test|||||||0.742
91667918|NCT00421304|183229616|SUPERIORITY|||||||0.486|||||||Wilcoxon's rank-sum test|||||||0.486
91667919|NCT00421304|183229616|SUPERIORITY|||||||0.49|||||||Wilcoxon's rank-sum test|||||||0.490
91667920|NCT00421304|183229617|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
91667921|NCT00421304|183229618|SUPERIORITY|||||||0.05|||||||Wilcoxon's rank-sum test|||||||0.050
91667922|NCT00421304|183229619|SUPERIORITY|||||||0.008|||||||Wilcoxon's rank-sum test|||||||0.008
91667923|NCT00421304|183229620|SUPERIORITY|||||||0.012|||||||Wilcoxon's rank-sum test|||||||0.012
91667924|NCT00421304|183229621|SUPERIORITY||||||<|0.001|||||||Wilcoxon's rank-sum test|||||||<0.001
91667925|NCT00919711|183229641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.6|||<|0.0001|TWO_SIDED|95.0|1.2|2.0|||ANCOVA||Denosumab - Risedronate|||2.0|1.2|<0.0001
91667926|NCT00919711|183229642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91667927|NCT00919711|183229643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|0.9|1.8|||ANCOVA||Denosumab - Risedronate|||1.8|0.9|<0.0001
91667928|NCT00919711|183229644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.8|2.8|||ANCOVA||Denosumab - Risedronate|||2.8|1.8|<0.0001
91667929|NCT04980456|183229696|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and sequence) and random (subject) effects. Difference = TOTAL30 minus Biofinity|||0.01||
91667930|NCT00122447|183229707|SUPERIORITY_OR_OTHER||Slope|-0.941|STANDARD_ERROR_OF_MEAN|1.229||0.449|TWO_SIDED|95.0|-3.435|1.552||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||1.552|-3.435|0.449
91667931|NCT00122447|183229707|SUPERIORITY_OR_OTHER||Slope|-2.677|STANDARD_ERROR_OF_MEAN|1.211||0.034|TWO_SIDED|95.0|-5.133|-0.221||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||-0.221|-5.133|0.034
91634932|NCT02607865|183162632|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0221|TWO_SIDED|95.0|0.61|0.96||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.96|0.61|=0.0221
91634933|NCT02607865|183162632|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.68|0.41|<0.0001
91667932|NCT00122447|183229707|SUPERIORITY_OR_OTHER||Slope|0.088|STANDARD_ERROR_OF_MEAN|1.21||0.943|TWO_SIDED|95.0|-2.367|2.542||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||2.542|-2.367|0.943
91667933|NCT00122447|183229708|SUPERIORITY_OR_OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.012||0.943|TWO_SIDED|95.0|-0.025|0.023||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||Null hypothesis: no difference between active treatment group compared to placebo.||0.023|-0.025|0.943
91667934|NCT00122447|183229708|SUPERIORITY_OR_OTHER||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.28|TWO_SIDED|95.0|-0.012|0.039||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.039|-0.012|0.280
91667935|NCT00122447|183229708|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.313|TWO_SIDED|95.0|-0.012|0.037||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.037|-0.012|0.313
91667936|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.97|1.49|||||"The Odds Ratio compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having an open encounter alert in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the trial and adjusting for provider-level clustering.||1.49|0.97|
91667937|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||"The OR compares between having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.59|0.83|
91667938|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.61|1.16|||||"The OR compares between having cold-state priming as an intervention factor in the arm the patient's primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.16|0.61|
91692413|NCT03187301|183279689|NON_INFERIORITY|4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Differeence|2.6|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|90.0|-1.6|6.9||||||||6.9|-1.6|
91484680|NCT01920555|182843333|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.72|TWO_SIDED|95.0|-4.65|0.96||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.96|-4.65|0.72
91484681|NCT01920555|182843334|SUPERIORITY||Mean Difference (Final Values)|-5.15||||0.33|TWO_SIDED|95.0|-12.44|2.14||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.14|-12.44|0.33
91525831|NCT02567825|182927168|SUPERIORITY||Difference of least-squares means|0.25|||||TWO_SIDED|95.0|-0.06|0.56|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean parental satisfaction score||0.56|-0.06|
91634934|NCT02607865|183162633|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33|||=|0.016|TWO_SIDED|95.0|1.05|1.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.68|1.05|=0.0160
91634935|NCT02607865|183162633|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.66|||=|0.0022|TWO_SIDED|95.0|0.51|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.51|=0.0022
91634936|NCT02607865|183162633|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.22|0.43||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.43|0.22|<0.0001
91634937|NCT03427528|183162654|OTHER|To assess paternal and maternal outcomes on the BDI-II we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our BDI-II.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
91634938|NCT03427528|183162655|OTHER|To assess paternal and maternal outcomes on the GAD-7, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our outcomes.|||||>|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
91634939|NCT03427528|183162656|OTHER|To assess paternal and maternal outcomes on the PSS-10, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
91634940|NCT03427528|183162656|OTHER|To assess paternal and maternal outcomes on the PSS-10 we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
91667939|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.64|||||"The OR compares between having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.88|
91667940|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.52|0.98|||||"The OR compares between having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||0.98|0.52|
91667941|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||"The OR compares between having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.89|
91525832|NCT02567825|182927169|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.98|1.18|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating at least one health care encounter since the previous study visit.||1.18|0.98|
91634941|NCT03427528|183162657|OTHER||||||>|0.05|||||||t-test, 2 sided|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
91634942|NCT01351415|183162660|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.84||||0.1044|TWO_SIDED|90.0|0.71|1.0|||Stratified Log-Rank test|||The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.||1.00|0.71|0.1044
91714483|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|7.95||0.9336||95.0|-15.0|16.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.3|-15.0|0.9336
91714484|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|7.71||0.2029||95.0|-25.0|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-25.0|0.2029
91714485|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.18||0.3833||95.0|-23.3|9.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-23.3|0.3833
91527837|NCT06173570|182930689|SUPERIORITY||Mean Difference (Net)|-1.21||||0.53|TWO_SIDED|95.0|-4.98|2.56|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||2.56|-4.98|0.530
91634943|NCT01351415|183162661|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.83||||0.0573|TWO_SIDED|90.0|0.7|0.98|||Stratified Log-Rank test|||PFS 2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.98|0.70|0.0573
91634944|NCT01351415|183162661|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.63||||0.0045|TWO_SIDED|90.0|0.49|0.83|||Stratified Log-Rank test|||PFS 3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.83|0.49|0.0045
91634945|NCT01351415|183162662|SUPERIORITY_OR_OTHER||Estimated difference in response rate|0.0237||||0.081|TWO_SIDED|90.0|-0.0156|0.063|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0630|-0.0156|0.0810
91634946|NCT01351415|183162663|SUPERIORITY_OR_OTHER||Estimated difference in Disease Control|0.0326||||0.0218|TWO_SIDED|90.0|-0.0288|0.094|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0940|-0.0288|0.0218
91634947|NCT01351415|183162664|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.29||||0.06|TWO_SIDED|90.0|0.09|0.9|||Stratified Log-Rank test|||The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.90|0.09|0.0600
91634948|NCT01351415|183162666|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.79||||0.0311|TWO_SIDED|90.0|0.65|0.95|||Stratified Log-Rank test|||TTP2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.95|0.65|0.0311
91634949|NCT01351415|183162666|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.69||||0.0326|TWO_SIDED|90.0|0.52|0.92|||Stratified Log-Rank test|||TTP3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.92|0.52|0.0326
91634950|NCT00247962|183162668|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.99|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91634951|NCT00247962|183162669|SUPERIORITY_OR_OTHER|||||||0.719|||||||ANCOVA|||baseline||||0.719
91634952|NCT00247962|183162669|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||week 16||||0.010
91634953|NCT03525613|183162673|SUPERIORITY||LS Mean Difference|-0.4114||||0.0004|TWO_SIDED|95.0|-0.6397|-0.1831|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.1831|-0.6397|0.0004
91634954|NCT03525613|183162673|SUPERIORITY||LS Mean Difference|-0.318||||0.0055|TWO_SIDED|95.0|-0.5423|-0.0937|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.0937|-0.5423|0.0055
91634955|NCT03525613|183162674|SUPERIORITY||LS Mean Difference|-0.9015|||<|0.0001|TWO_SIDED|95.0|-1.3026|-0.5004|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.5004|-1.3026|<0.0001
91634956|NCT03525613|183162674|SUPERIORITY||LS Mean Difference|-0.7426||||0.0002|TWO_SIDED|95.0|-1.1282|-0.357|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3570|-1.1282|0.0002
91667942|NCT04284553|183229711|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||"The OR compares patients having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.19|0.55|
91634957|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2234||||0.0007|TWO_SIDED|95.0|-0.3522|-0.0946|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0946|-0.3522|0.0007
91667943|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-17.6|21.2|||||"The estimate compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having open encounter in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.2|-17.6|
91667944|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-41.8|17.5|||||"The estimate compares having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.5|-41.8|
91667945|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|39.5|||||TWO_SIDED|95.0|11.6|67.4|||||"The estimate compares having cold-state priming as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||67.4|11.6|
91714486|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|7.72||0.8152||95.0|-17.0|13.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.4|-17.0|0.8152
91484682|NCT01920555|182843334|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.53|TWO_SIDED|95.0|-9.03|4.72||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||4.72|-9.03|0.53
91634958|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1618||||0.0116|TWO_SIDED|95.0|-0.2874|-0.0361|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0361|-0.2874|0.0116
91634959|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1862||||0.0181|TWO_SIDED|95.0|-0.3406|-0.0318|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0318|-0.3406|0.0181
91634960|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1526||||0.0467|TWO_SIDED|95.0|-0.303|-0.0023|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0023|-0.3030|0.0467
91667946|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|-1.74|||||TWO_SIDED|95.0|-30.4|26.9|||||"The estimate compares having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||26.9|-30.4|
91667947|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-37.6|17.4|||||"The estimate compares having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.4|-37.6|
91667948|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|-24.1|32.5|||||"The estimate compares having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||32.5|-24.1|
91667949|NCT04284553|183229713|SUPERIORITY||Mean Difference (Final Values)|-12.0|||||TWO_SIDED|95.0|-45.5|21.5|||||"The estimate compares having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.5|-45.5|
91667950|NCT00578968|183229714|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
91634961|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2265||||0.0019|TWO_SIDED|95.0|-0.3696|-0.0834|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0834|-0.3696|0.0019
91634962|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1586||||0.0288|TWO_SIDED|95.0|-0.3009|-0.0164|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0164|-0.3009|0.0288
91634963|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2341||||0.008|TWO_SIDED|95.0|-0.4071|-0.0611|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0611|-0.4071|0.0080
91667951|NCT00578968|183229715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91667952|NCT00578968|183229716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91667953|NCT00578968|183229717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91667954|NCT00578968|183229718|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||Comparison between the two groups at baseline resting.||||0.13
91667955|NCT00578968|183229718|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Comparison was made between the two groups at baseline peak exercise||||<0.01
91667956|NCT00578968|183229719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91667957|NCT00578968|183229720|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91667958|NCT00578968|183229721|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
91667959|NCT00578968|183229722|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
91667960|NCT00578968|183229723|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
91525833|NCT02567825|182927170|SUPERIORITY|Reports for which the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.88|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating a parent missed work due to child's illness.||1.41|0.88|
91525834|NCT02567825|182927171|SUPERIORITY|Reports indicating the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.89|1.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating the need for special childcare arrangements due to child's illness.||1.48|0.89|
91525835|NCT02567825|182927172|SUPERIORITY||Difference of least-square means|-0.05|||||TWO_SIDED|95.0|-0.13|0.02|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey score||0.02|-0.13|
91525836|NCT02567825|182927172|SUPERIORITY||Difference of least-square means|0.06|||||TWO_SIDED|95.0|-0.13|0.24|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey--children's overall QOL score.||0.24|-0.13|
91667961|NCT00578968|183229724|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
91667962|NCT00578968|183229725|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
91667963|NCT00578968|183229726|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||||||0.005
91634964|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2459||||0.0007|TWO_SIDED|95.0|-0.3886|-0.1031|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1031|-0.3886|0.0007
91667964|NCT00578968|183229727|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
91667965|NCT00578968|183229728|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
91667966|NCT00578968|183229729|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||||||0.60
91525837|NCT02567825|182927173|SUPERIORITY||Difference of least-square means|-0.04|||||TWO_SIDED|95.0|-1.55|1.47|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire score.||1.47|-1.55|
91667967|NCT00578968|183229730|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||||||0.35
91667968|NCT00578968|183229731|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANOVA|||||||0.65
91667969|NCT00578968|183229732|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
91667970|NCT00578968|183229733|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison was made between groups at pretreatment resting time period.||||0.73
91667971|NCT00578968|183229733|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Comparison was made between groups at pretreatment peak exercise time period.||||0.11
91667972|NCT00578968|183229734|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
91667973|NCT00578968|183229735|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
91667974|NCT00578968|183229736|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||ANOVA|||||||0.09
91667975|NCT00578968|183229737|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
91667976|NCT00578968|183229738|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
91667977|NCT00578968|183229739|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANOVA|||||||0.19
91667978|NCT00578968|183229740|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
91667979|NCT00578968|183229741|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
91667980|NCT00603564|183229744|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||endpoint was analyzed in terms of time by comparison of mean +- SD||||<0.001
91667981|NCT00603564|183229745|SUPERIORITY_OR_OTHER|||||||7e-06||95.0|||||Chi-squared|||||||0.000007
91667982|NCT01350934|183229746|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|1.95|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|0.8|3.1|||Longitudinal data analysis|||||3.1|0.8|<0.001
91667983|NCT01350934|183229747|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|2.92|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.8|4.1|||Longitudinal data analysis|||||4.1|1.8|<0.001
91667984|NCT01350934|183229748|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-42.37|||<|0.001|TWO_SIDED|95.0|-48.16|-36.67|||Constrained longitudinal data analysis|||||-36.67|-48.16|<0.001
91667985|NCT01350934|183229749|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-52.03|||<|0.001|TWO_SIDED|95.0|-59.04|-45.3|||Constrained longitudinal data analysis|||||-45.30|-59.04|<0.001
91667986|NCT01350934|183229750|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.07|||<|0.001|TWO_SIDED|95.0|-57.29|-44.99|||Constrained longitudinal data analysis|||||-44.99|-57.29|<0.001
91667987|NCT01350934|183229751|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.96|||<|0.001|TWO_SIDED|95.0|-58.77|-45.39|||Constrained longitudinal data analysis|||||-45.39|-58.77|<0.001
91667988|NCT01350934|183229752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0279|||<|0.001|TWO_SIDED|95.0|0.0074|0.1048|||Cochran-Mantel-Haenszel|||Odds Ratio comparison of percentage of participants with \<20 ng/mL of serum 25-hydroxyvitamin (OH) D between Fosamax Plus group and Calcitriol group.||0.1048|0.0074|<0.001
91714487|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|7.81||0.1739||95.0|-26.1|4.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-26.1|0.1739
91714488|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.94||0.3392||95.0|-8.0|23.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-8.0|0.3392
91714489|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|7.71||0.913||95.0|-16.0|14.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-16.0|0.9130
91792566|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.73||0.229|TWO_SIDED|95.0|-5.6|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-5.6|0.229
91484683|NCT01920555|182843334|SUPERIORITY||Mean Difference (Final Values)|-9.85||||0.02|TWO_SIDED|95.0|-16.56|-3.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-3.15|-16.56|0.02
91527838|NCT06173570|182930689|SUPERIORITY||Mean Difference (Net)|-0.85||||0.654|TWO_SIDED|95.0|-4.56|2.87|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||2.87|-4.56|0.654
91634965|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.8702|||<|0.0001|TWO_SIDED|95.0|-1.274|-0.4664|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.4664|-1.2740|<0.0001
91634966|NCT03525613|183162675|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7189||||0.0003|TWO_SIDED|95.0|-1.1039|-0.3339|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3339|-1.1039|0.0003
91634967|NCT02120469|183162736|OTHER||||||||||||||||||Dose level B1 (eribulin 1.1 mg/m2 days 1 and 8 every 3 weeks with everolimus 5 mg daily) was defined as the highest dose with acceptable toxicity (RP2D).|||
91634968|NCT02176005|183162753|OTHER||Contrast (B/A)|0.0093|||<|1e-06|TWO_SIDED|95.0|0.006|0.0144|||General linear model|||||0.0144|0.0060|<.000001
91634969|NCT02176005|183162754|OTHER||Contrast (B/A)|0.0096|||<|1e-06|TWO_SIDED|95.0|0.0061|0.0151|||General linear model|||||0.0151|0.0061|<.000001
91634970|NCT02176005|183162755|OTHER||Contrast (B/A)|0.9811||||0.806|TWO_SIDED|95.0|0.8608|1.1182|||General linear model|||||1.1182|0.8608|0.806
91634971|NCT02176005|183162756|OTHER||Contrast (B/A)|0.8785||||0.139|TWO_SIDED|95.0|0.76|1.0155|||General linear model|||||1.0155|0.7600|0.139
91634972|NCT02176005|183162757|OTHER||Contrast (B/A)|1.1763||||0.104|TWO_SIDED|95.0|0.9982|1.3861|||General linear model|||||1.3861|0.9982|0.104
91634973|NCT02176005|183162758|OTHER||Contrast (B/A)|0.9391||||0.519|TWO_SIDED|95.0|0.7969|1.1066|||General linear model|||||1.1066|0.7969|0.519
91634974|NCT01981096|183162774|SUPERIORITY|||||||0.011||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.011
91634975|NCT01981096|183162775|SUPERIORITY|||||||0.055||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.055
91634976|NCT01899729|183162796|OTHER|Used mixed effects model||||||0.06|||||||Mixed Models Analysis|||||||0.06
91634977|NCT01454531|183162800|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired values|t-test, 2 sided|||The null hypothesis is no changes in IgE-blocking factor values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in IgE-blocking factor values||||<0.001
91667989|NCT02733627|183229761|OTHER||Slope|3.8266|STANDARD_ERROR_OF_MEAN|0.2967|||TWO_SIDED|95.0|3.2155|4.4376||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.4376|3.2155|
91667990|NCT02733627|183229762|OTHER||Slope|4.181|STANDARD_ERROR_OF_MEAN|0.3247|||TWO_SIDED|95.0|3.5094|4.8527||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.8527|3.5094|
91667991|NCT02733627|183229763|OTHER||Slope|1.8868|STANDARD_ERROR_OF_MEAN|0.3069|||TWO_SIDED|95.0|1.2503|2.5234||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|2.5234|1.2503|
91667992|NCT02733627|183229764|OTHER||Slope|3.0677|STANDARD_ERROR_OF_MEAN|0.4844|||TWO_SIDED|95.0|2.0631|4.0723||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.0723|2.0631|
91667993|NCT02048813|183229796|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.56|||Log Rank|||||0.56|0.22|<.001
91667994|NCT02048813|183229797|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.05|0.54|||Log Rank|||||0.54|0.05|<.001
91667995|NCT01708954|183229808|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|80.0|0.25|0.53|||||Hazard ratio of Arm C/Arm A|||0.53|0.25|
91667996|NCT01708954|183229808|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|80.0|0.27|0.55|||||Hazard ratio of Arm B/Arm A|||0.55|0.27|
91667997|NCT01721772|183229866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.6|||Stratified Log Rank Test|||||0.60|0.30|<0.0001
91484684|NCT01920555|182843334|SUPERIORITY||Mean Difference (Final Values)|-7.72||||0.08|TWO_SIDED|95.0|-14.52|-0.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.93|-14.52|0.08
91667998|NCT01721772|183229867|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.56|||Stratified Log Rank Test|||||0.56|0.34|<0.0001
91667999|NCT01721772|183229869|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.43|||<|0.0001|TWO_SIDED|95.0|2.75|7.13|||Cochran-Mantel-Haenszel|||||7.13|2.75|<0.0001
91668000|NCT01721772|183229870|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.37|||||TWO_SIDED|95.0|0.24|0.56|||||PD-L1 positive group|||0.56|0.24|
91668001|NCT01721772|183229870|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.8|||||PD-L1 negative group|||0.80|0.45|
91668002|NCT01721772|183229873|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.41|0.65||||||||0.65|0.41|
91668003|NCT02754492|183229875|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.950|
91668004|NCT02754492|183229875|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
91714490|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.6||95.0|-20.5|11.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-20.5|0.6000
91714491|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|7.75||0.4445||95.0|-9.3|21.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.2|-9.3|0.4445
91714492|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|7.85||0.9656||95.0|-15.8|15.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.1|-15.8|0.9656
91714493|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|8.02||0.5679||95.0|-11.2|20.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.4|-11.2|0.5679
91792567|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.65||0.863|TWO_SIDED|95.0|-3.6|3.0|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||3.0|-3.6|0.863
91634978|NCT01454531|183162801|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired samples|t-test, 2 sided|||The null hypothesis is no changes in Phleum specific IgG4 values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in Phleum specific IgG4 values||||<0.001
91634979|NCT01454531|183162802|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Parallel Line Assay|||Parallel Line Assay is based on the construction of two dose-response regression lines obtained plotting the allergen concentration used to prick test the subjects against the wheal size obtained. ANOVA allows to check for regression, linearity and parallelism. A common slope and y-intercepts are calculated. The CTI is the exponentiation of the difference between y-intercepts divided by the common slope. (Finney D.J., Statistical Method in Biological Assay, 1978).||||<0.01
91634980|NCT03756285|183162815|SUPERIORITY||Least Square Means Ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.12|0.52|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||0.52|0.12|<0.001
91634981|NCT03756285|183162816|SUPERIORITY||Least Square Means Ratio|0.97||||0.568|ONE_SIDED|95.0|0.74||||ANCOVA|Covariates: atrial fibrillation status at randomization, baseline value, treatment|||||0.74|0.568
91634982|NCT03756285|183162817|SUPERIORITY||Mean Difference (Final Values)|21.8||||0.407|TWO_SIDED|95.0|-30.5|74.1|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||74.1|-30.5|0.407
91634983|NCT05315297|183162835|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91634984|NCT05315297|183162836|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91634985|NCT05315297|183162837|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91634986|NCT05315297|183162838|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
91634987|NCT05315297|183162839|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91634988|NCT05315297|183162840|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91634989|NCT00711009|183162848|NON_INFERIORITY_OR_EQUIVALENCE|The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was \>/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.|Diff. in Percentage of Subj. Responding|-1.6||||0.85|TWO_SIDED|95.0|-12.0|8.8|||exact binomial method|||The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of -20% (with a type I error rate of 0.05).||8.8|-12.0|0.850
91634990|NCT02534324|183162931|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
91634991|NCT02534324|183162932|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
91634992|NCT05064449|183162965|OTHER||Geometric Mean Ratio (%)|116.59|||||TWO_SIDED|90.0|91.3|148.9|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) of Cmax for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||148.90|91.30|
91634993|NCT05064449|183162966|OTHER||Geometric Mean Ratio (%)|107.31|||||TWO_SIDED|90.0|88.02|130.83|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of Cmax for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||130.83|88.02|
91634994|NCT05064449|183162967|OTHER||Geometric Mean Ratio (%)|123.96|||||TWO_SIDED|90.0|106.21|144.68|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||144.68|106.21|
91484685|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.08|TWO_SIDED|95.0|-1.83|-0.22|||Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.22|-1.83|0.08
91484686|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.82|TWO_SIDED|95.0|-1.02|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-1.02|0.82
91668005|NCT02754492|183229875|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
91525838|NCT02567825|182927173|SUPERIORITY||Difference of least-square means|0.03|||||TWO_SIDED|95.0|-0.14|0.2|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire--caregiver's overall QOL score.||0.20|-0.14|
91525839|NCT01737684|182927180|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.27|||||TWO_SIDED|90.0|0.96|1.67|||ANCOVA|||||1.67|0.96|
91525840|NCT01737684|182927183|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.35|||||TWO_SIDED|90.0|0.88|2.06|||ANCOVA|||||2.06|0.88|
91668006|NCT02754492|183229876|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.950|
91668007|NCT02754492|183229876|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
91668008|NCT02754492|183229876|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
91668009|NCT04542694|183229883|SUPERIORITY||The difference in proportions|0.1313||||0.0372|TWO_SIDED|95.0|-0.0004|0.2367|||Chi-squared|||A comparative analysis of the rate of clinical status improvement by 2 or more categories. The difference in percentages between the AREPLIVIR arm and the standard therapy arm (pa-pb)||0.2367|-0.0004|0.0372
91668010|NCT04542694|183229884|SUPERIORITY||The difference in days|4.0|||<|0.0001|TWO_SIDED||||||Log Rank|||Comparative analysis of time to clinical status improvement by categorical ordinal clinical improvement scale between the AREPLIVIR arm and the standard therapy arm||||<0.0001
91668011|NCT04542694|183229885|SUPERIORITY||The difference in percentages|22.5||||0.00016|TWO_SIDED||||||Chi-squared|||||||0.00016
91668012|NCT04542694|183229886|SUPERIORITY||Median Difference (Final Values)|1.55||||0.052|TWO_SIDED||||||Log Rank|||||||0.052
91668013|NCT04542694|183229887|SUPERIORITY|||||||0.1953|||||||Chi-squared|||||||0.1953
91668014|NCT04542694|183229888|SUPERIORITY|||||||0.4975|||||||Chi-squared|||||||0.4975
91668015|NCT04633642|183229897|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_DEVIATION|0.74|<|0.01|TWO_SIDED|||||The threshold for statistical significances was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
91668016|NCT04633642|183229898|SUPERIORITY||Mean Difference (Final Values)|1.61|STANDARD_DEVIATION|0.17|<|0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
91668017|NCT04633642|183229899|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.79|<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91525841|NCT03097861|182927187|OTHER|Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|||||=|0.002|||||||ANCOVA|||||||=0.0020
91525842|NCT03097861|182927187|OTHER||||||<|0.0001|||||||ANCOVA|||Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect||||<0.0001
91634995|NCT05064449|183162968|OTHER||Geometric Mean Ratio (%)|100.57|||||TWO_SIDED|90.0|86.17|117.38|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||117.38|86.17|
91634996|NCT05064449|183162969|OTHER||Geometric Mean Ratio (%)|121.97|||||TWO_SIDED|90.0|103.47|143.79|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||143.79|103.47|
91634997|NCT05064449|183162970|OTHER||Geometric Mean Ratio (%)|107.38|||||TWO_SIDED|90.0|91.68|125.77|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||125.77|91.68|
91634998|NCT05064449|183162971|OTHER||Median Difference (Final Values)|0.003|||=|0.2305|TWO_SIDED|90.0|-0.001|0.126|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Itraconazole) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.126|-0.001|=0.2305
91634999|NCT05064449|183162972|OTHER||Median Difference (Final Values)|-0.096|||=|0.583|TWO_SIDED|90.0|-0.128|0.018|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Mefenamic Acid) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.018|-0.128|=0.5830
91635000|NCT01432236|183162978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0001|TWO_SIDED|95.0|-0.91|-0.31||Primary analysis was two-sided and performed at the 0.05 significance level.|Mixed Models Analysis|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-0.91|0.0001
91635001|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|||<|0.0001|TWO_SIDED|95.0|-9.33|-3.87||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-3.87|-9.33|<0.0001
91635002|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42||||0.0078|TWO_SIDED|95.0|-0.74|-0.11||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.11|-0.74|0.0078
91635003|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.0014|TWO_SIDED|95.0|-1.36|-0.33||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.33|-1.36|0.0014
91635004|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.005|TWO_SIDED|95.0|-1.01|-0.18||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.18|-1.01|0.0050
91635005|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.0002|TWO_SIDED|95.0|-1.14|-0.36||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.36|-1.14|0.0002
91635006|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.0|-0.28||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.28|-1.00|0.0006
91635007|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.0315|TWO_SIDED|95.0|-0.85|-0.04||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.04|-0.85|0.0315
91668018|NCT04633642|183229900|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_DEVIATION|0.44||0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical di↵erence of 37% to detect a statistically significant between groups.||||0.01
91668019|NCT04633642|183229901|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.93|TWO_SIDED|||||The threshold for statistics significance was p\<0.05|t-test, 2 sided|||||||0.93
91668020|NCT04633642|183229902|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.711|TWO_SIDED||||||t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical difference of 37% to detect a statistically significant between groups.||||0.711
91668021|NCT01207752|183229910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.550
91668022|NCT01717313|183229911|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status||||-0.19|-0.59|<0.001
91668023|NCT01717313|183229912|SUPERIORITY_OR_OTHER||Differences in percentages vs. placebo|-8.2|||||TWO_SIDED|95.0|-18.8|2.6||||||||2.6|-18.8|
91668024|NCT01717313|183229913|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.1|4.5||||||||4.5|-3.1|
91668025|NCT01717313|183229914|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|-5.8|||||TWO_SIDED|95.0|-16.4|4.9||||||||4.9|-16.4|
91668026|NCT01717313|183229915|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.5|4.8||||||||4.8|-3.5|
91668027|NCT01717313|183229916|SUPERIORITY_OR_OTHER||Between-group rate difference|20.3|||<|0.001|TWO_SIDED|95.0|10.5|29.8|||Miettinen & Nurminen method|||||29.8|10.5|<0.001
91668028|NCT01717313|183229917|SUPERIORITY_OR_OTHER||Between-group rate difference|11.4||||0.001|TWO_SIDED|95.0|4.8|18.6|||Miettinen & Nurminen method|||||18.6|4.8|0.001
91668029|NCT01717313|183229918|SUPERIORITY_OR_OTHER||Difference in the least squares means|-10.3||||0.036|TWO_SIDED|95.0|-19.9|-0.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.7|-19.9|0.036
91668030|NCT01717313|183229919|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.6||||0.177|TWO_SIDED|95.0|-28.6|5.3|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||5.3|-28.6|0.177
91668031|NCT01717313|183229924|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.53|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.32|-0.75|<0.001
91668032|NCT01717313|183229925|SUPERIORITY_OR_OTHER||Difference in the least squares means|-13.2||||0.014|TWO_SIDED|95.0|-23.7|-2.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-2.7|-23.7|0.014
91668033|NCT01717313|183229926|SUPERIORITY_OR_OTHER||Difference in the least squares means|-20.5||||0.031|TWO_SIDED|95.0|-39.0|-1.9|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-1.9|-39.0|0.031
91668034|NCT02533466|183229936|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|-0.08||||0.2673|TWO_SIDED|95.0|-1.0|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.0|0.2673
91668035|NCT02533466|183229937|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-0.92||||0.069|TWO_SIDED|95.0|-1.8|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum Test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.8|0.0690
91668036|NCT02533466|183229938|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.5||||0.068|TWO_SIDED|95.0|-2.7|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-2.7|0.0680
91668037|NCT02533466|183229939|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.83||||0.0654|TWO_SIDED|95.0|-3.0|0.0||P-value is calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test.||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product"|||0.0|-3.0|0.0654
91668038|NCT02533466|183229940|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-1.4||||0.6061|TWO_SIDED|95.0|-6.8|4.1||P value obtained from the ANCOVA analysis|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||4.1|-6.8|0.6061
91525843|NCT03502616|182927236|SUPERIORITY||Difference in percentage|27.08|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|15.89|38.28|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach.||38.28|15.89|<0.0001
91668039|NCT02533466|183229941|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-2.3||||0.408|TWO_SIDED|95.0|-7.9|3.3||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product|||3.3|-7.9|0.4080
91668040|NCT02533466|183229942|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|0.21||||0.4611|TWO_SIDED|95.0|-0.4|0.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||0.8|-0.4|0.4611
91668041|NCT02533466|183229943|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Net)|0.09||||0.3939|TWO_SIDED|95.0|-0.1|0.3||P value obtained from the ANCOVA analysis.|ANCOVA|||||0.3|-0.1|0.3939
91668042|NCT02533466|183229944|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|0.34||||0.7829|TWO_SIDED|95.0|-2.2|2.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||2.8|-2.2|0.7829
91668043|NCT02533466|183229945|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Mean Difference (Final Values)|-0.08||||0.9121|TWO_SIDED|95.0|-1.6|1.4||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||1.4|-1.6|0.9121
91668044|NCT01196390|183229952|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.85|TWO_SIDED|95.0|0.69|1.36|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.||1.36|0.69|0.85
91668045|NCT01196390|183229953|SUPERIORITY|||||||0.71|||||||Chi-squared|Two-sided significance level = 0.05||||||0.71
91668046|NCT01196390|183229954|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.69|1.47|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|||1.47|0.69|0.95
91668047|NCT01196390|183229956|SUPERIORITY|||||||0.39||||||One-side significance level = 0.05|Chi-squared|||6-8 weeks||||0.39
91714494|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|7.79||0.5619||95.0|-19.9|10.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-19.9|0.5619
91714495|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.31||0.993||95.0|-16.3|16.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-16.3|0.9930
91714496|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|7.79||0.6892||95.0|-12.2|18.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-12.2|0.6892
91668048|NCT01196390|183229956|SUPERIORITY|||||||0.78||||||One-side significance level = 0.05|Chi-squared|||1 year||||0.78
91668049|NCT01196390|183229956|SUPERIORITY|||||||0.28||||||One-side significance level = 0.05|Chi-squared|||2 years||||0.28
91668050|NCT01196390|183229959|SUPERIORITY||Odds Ratio (OR)|2.35||||0.021|TWO_SIDED|95.0|1.13|4.86|||Regression, Logistic|||Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.||4.86|1.13|0.021
91714497|NCT00676403|183320248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|7.89||0.4928||95.0|-21.0|10.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.1|-21.0|0.4928
91792568|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.403|TWO_SIDED|95.0|-1.9|4.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.7|-1.9|0.403
91525844|NCT03502616|182927237|SUPERIORITY||Difference in percentage|28.17|STANDARD_ERROR_OF_MEAN|5.06|<|0.0001|TWO_SIDED|95.0|18.26|38.09|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.09|18.26|<0.0001
91668051|NCT03480022|183229964|SUPERIORITY||||||<|0.002|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.002
91668052|NCT03480022|183229965|SUPERIORITY||||||<|0.006|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.006
91668053|NCT03480022|183229966|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures nested design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.001
91668054|NCT03480022|183229967|SUPERIORITY||||||<|0.002|||||||ANOVA|one-way ANOVA||||||<0.002
91668055|NCT03480022|183229968|SUPERIORITY||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||||||<0.007
91668056|NCT03480022|183229969|SUPERIORITY||||||<|0.049|||||||Wilcoxon (Mann-Whitney)|||||||<0.049
91668057|NCT03480022|183229970|SUPERIORITY||||||<|0.011|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.011
91668058|NCT03480022|183229971|SUPERIORITY||||||<|0.038|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.038
91668059|NCT03480022|183229972|SUPERIORITY||||||<|0.048|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.048
91668060|NCT03480022|183229973|SUPERIORITY||||||<|0.018|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.018
91668061|NCT03480022|183229974|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
91668062|NCT03480022|183229975|SUPERIORITY||||||<|0.034|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.034
91668063|NCT03480022|183229976|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
91635008|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.0003|TWO_SIDED|95.0|-1.17|-0.35||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.35|-1.17|0.0003
91635009|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0007|TWO_SIDED|95.0|-1.11|-0.31||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-1.11|0.0007
91668064|NCT03480022|183229977|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.0001
91668065|NCT03480022|183229978|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
91668066|NCT03480022|183229979|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
91668067|NCT03480022|183229980|SUPERIORITY||||||<|0.021|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.021
91668068|NCT03480022|183229981|SUPERIORITY||||||<|0.009|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.009
91668069|NCT03480022|183229982|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
91668070|NCT03480022|183229983|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
91668071|NCT03480022|183229984|SUPERIORITY||||||<|0.042|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.042
91668072|NCT03480022|183229985|SUPERIORITY||||||<|0.033|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.033
91668073|NCT03480022|183229986|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
91668074|NCT03480022|183229987|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
91668075|NCT03480022|183229988|SUPERIORITY||||||<|0.016|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.016
91714498|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|5.1||0.2719||95.0|-4.4|15.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.6|-4.4|0.2719
91668076|NCT03480022|183229989|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
91668077|NCT03480022|183229990|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.01
91668078|NCT03480022|183229991|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
91668079|NCT03480022|183229992|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
91668080|NCT03980522|183230026|OTHER||Inter-subject variance|19.1908|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and standard deviation (SD) from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91714499|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|5.02||0.693||95.0|-7.9|11.8|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-7.9|0.6930
91714500|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|5.24||0.7178||95.0|-12.2|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-12.2|0.7178
91714501|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.96||0.8037||95.0|-11.0|8.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-11.0|0.8037
91714502|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|5.02||0.0832||95.0|-1.2|18.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.6|-1.2|0.0832
91714503|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|5.17||0.3554||95.0|-5.4|14.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.9|-5.4|0.3554
91714504|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|4.96||0.9538||95.0|-9.5|10.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.0|-9.5|0.9538
91525845|NCT03502616|182927244|SUPERIORITY||Difference in percentage|18.28|STANDARD_ERROR_OF_MEAN|4.7||0.0001|TWO_SIDED|95.0|9.06|27.5|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||27.50|9.06|0.0001
91525846|NCT03502616|182927244|SUPERIORITY||Difference in percentage|31.35|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|20.64|42.06|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.06|20.64|<0.0001
91668081|NCT03980522|183230026|OTHER||Inter-subject variance|0.0018|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668082|NCT03980522|183230026|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91635010|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.0048|TWO_SIDED|95.0|-0.93|-0.17||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.17|-0.93|0.0048
91635011|NCT01432236|183162980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.53||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.53|-1.32|<0.0001
91635012|NCT01432236|183162981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.||||0.0637
91635013|NCT01432236|183162982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using CMH test with modified ridit transformation.||||0.1160
91635014|NCT01432236|183162983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0007
91635015|NCT01432236|183162983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0205
91635016|NCT01432236|183162984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.0001|TWO_SIDED|95.0|0.31|0.84||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.||0.84|0.31|<0.0001
91635017|NCT01432236|183162985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.81||||0.0018|TWO_SIDED|95.0|-12.66|-2.96||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-2.96|-12.66|0.0018
91635018|NCT01432236|183162986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.0117|TWO_SIDED|95.0|-10.29|-1.31||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors||-1.31|-10.29|0.0117
91635019|NCT01432236|183162987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35||||0.0511|TWO_SIDED|95.0|-0.04|16.74||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||16.74|-0.04|0.0511
91668083|NCT03980522|183230026|OTHER||Intra-subject variance|12.6852|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668084|NCT03980522|183230026|OTHER||Intra-subject variance|0.1842|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668085|NCT03980522|183230026|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91525847|NCT03502616|182927244|SUPERIORITY||Difference in percentage|32.24|STANDARD_ERROR_OF_MEAN|5.57|<|0.0001|TWO_SIDED|95.0|21.32|43.17|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||43.17|21.32|<0.0001
91525848|NCT03502616|182927244|SUPERIORITY||Difference in percentage|34.61|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|23.63|45.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.58|23.63|<0.0001
91792569|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.74||0.597|TWO_SIDED|95.0|-2.5|4.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.4|-2.5|0.597
91792570|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.32||0.416|TWO_SIDED|95.0|-2.7|6.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||6.5|-2.7|0.416
91635020|NCT01432236|183162988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13||||0.1139|TWO_SIDED|95.0|-0.29|0.03||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.||0.03|-0.29|0.1139
91635021|NCT01432236|183162990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.50|-1.40|<0.0001
91635022|NCT01432236|183162990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.88||||0.0005|TWO_SIDED|95.0|-1.37|-0.39||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.||-0.39|-1.37|0.0005
91635023|NCT01432236|183162992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.3854|TWO_SIDED|95.0|-0.02|0.06||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.06|-0.02|0.3854
91635024|NCT01432236|183162994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55||||0.0085|TWO_SIDED|95.0|0.14|0.97||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.97|0.14|0.0085
91635025|NCT04450394|183163017|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% Confidence Interval is below 0.4.|LS Mean Difference|0.06|||||TWO_SIDED|90.0|-0.11|0.24||||||||0.24|-0.11|
91635026|NCT02194699|183163021|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.84||||0.4656|TWO_SIDED|95.0|0.53|1.34|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.34|0.53|0.4656
91635027|NCT02194699|183163021|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.13||||0.4126|TWO_SIDED|95.0|0.85|1.5|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.50|0.85|0.4126
91635028|NCT02194699|183163021|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|15.83||||0.4656|TWO_SIDED|95.0|-33.71|47.01|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||47.01|-33.71|0.4656
91668086|NCT03980522|183230027|OTHER||Inter-subject variance|34.1446|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91792571|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.24||0.77|TWO_SIDED|95.0|-3.8|5.1|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.1|-3.8|0.770
91668087|NCT03980522|183230027|OTHER||Inter-subject variance|0.1326|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668088|NCT03980522|183230027|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91484687|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.0072|TWO_SIDED|95.0|-2.02|-0.54||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.54|-2.02|0.00720
91484688|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.04884|TWO_SIDED|95.0|-1.81|-0.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.29|-1.81|0.04884
91668089|NCT03980522|183230027|OTHER||Intra-subject variance|0.0548|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668090|NCT03980522|183230027|OTHER||Intra-subject variance|0.0134|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91484689|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.48|TWO_SIDED|95.0|-1.7|0.28||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.28|-1.70|0.48
91484690|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.82|TWO_SIDED|95.0|-1.32|0.55||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.55|-1.32|0.82
91484691|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.16|TWO_SIDED|95.0|-1.91|-0.09||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.09|-1.91|0.16
91484692|NCT01920555|182843335|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.27|TWO_SIDED|95.0|-1.78|0.07||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.07|-1.78|0.27
91668091|NCT03980522|183230027|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91792572|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.31||0.798|TWO_SIDED|95.0|-4.0|5.2|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.2|-4.0|0.798
91525849|NCT03502616|182927244|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|5.9||0.536|TWO_SIDED|95.0|-7.92|15.22|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.22|-7.92|0.5360
91668092|NCT03980522|183230028|OTHER||Inter-subject variance|2.8139|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668093|NCT03980522|183230028|OTHER||Inter-subject variance|6.9999|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668094|NCT03980522|183230028|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668095|NCT03980522|183230028|OTHER||Intra-subject variance|0.9693|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668096|NCT03980522|183230028|OTHER||Intra-subject variance|0.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668097|NCT03980522|183230028|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
91668098|NCT03980522|183230029|OTHER||Inter-subject variance|1.9968|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668099|NCT03980522|183230029|OTHER||Inter-subject variance|0.9047|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668100|NCT03980522|183230029|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668101|NCT03980522|183230029|OTHER||Intra-subject variance|1.7598|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668102|NCT03980522|183230029|OTHER||Intra-subject variance|2.849|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668103|NCT03980522|183230029|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
91668104|NCT01320722|183230032|SUPERIORITY|||||||0.72|||||||Repeated Measures Analysis|||Week 8||||0.72
91668105|NCT01320722|183230033|SUPERIORITY|||||||0.77||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.77
91668106|NCT01320722|183230034|SUPERIORITY|||||||0.57||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.57
91668107|NCT01320722|183230035|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||||||0.8
91668108|NCT01320722|183230035|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
91668109|NCT01320722|183230036|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
91668110|NCT01320722|183230036|SUPERIORITY|||||||0.7|||||||Repeated Measures Analysis|||||||0.7
91668111|NCT01320722|183230037|SUPERIORITY|||||||0.3|||||||Repeated Measures Analysis|||||||0.3
91668112|NCT01320722|183230037|SUPERIORITY|||||||0.1|||||||Repeated Measures Analysis|||||||0.1
91668113|NCT01320722|183230038|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|Statistical significance was set for a 2-tailed P \<0.05.||Week 8||||0.35
91668114|NCT01320722|183230038|SUPERIORITY|||||||0.7||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.7
91792573|NCT02129777|183462755|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.767|TWO_SIDED|95.0|-4.1|5.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.5|-4.1|0.767
91635029|NCT02194699|183163021|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.03||||0.8027|TWO_SIDED|95.0|0.81|1.31|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.||1.31|0.81|0.8027
91635030|NCT02194699|183163021|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|-3.14||||0.8027|TWO_SIDED|95.0|-31.46|19.08|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.||19.08|-31.46|0.8027
91635031|NCT02194699|183163022|SUPERIORITY||Least square (LS) Mean difference|1.86||||0.6033|TWO_SIDED|95.0|-5.16|8.88|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||8.88|-5.16|0.6033
91635032|NCT02194699|183163022|SUPERIORITY||LS Mean difference|3.37||||0.1276|TWO_SIDED|95.0|-0.97|7.7|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||7.70|-0.97|0.1276
91668115|NCT01320722|183230038|SUPERIORITY|||||||0.06||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.06
91668116|NCT01320722|183230039|SUPERIORITY|||||||0.92||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall SBP||||0.92
91668117|NCT01320722|183230039|SUPERIORITY|||||||0.64||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall DBP||||0.64
91668118|NCT01320722|183230039|SUPERIORITY|||||||0.8||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Awake SBP||||0.80
91668119|NCT01320722|183230039|SUPERIORITY|||||||0.97||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Asleep SBP at Week 8||||0.97
91668120|NCT01320722|183230039|SUPERIORITY|||||||0.34|||||||Repeated Measures Analysis|||Overall SBP||||0.34
91668121|NCT01320722|183230039|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysi|||Overall DBP||||0.59
91668122|NCT01320722|183230039|SUPERIORITY|||||||0.57|||||||Repeated Measures Analysis|||Awake SBF||||0.57
91668123|NCT01320722|183230039|SUPERIORITY|||||||0.08|||||||Repeated Measures Analysis|||Asleep SBP||||0.08
91668124|NCT01320722|183230039|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysis|||Overall SBP||||0.59
91668125|NCT01320722|183230039|SUPERIORITY|||||||0.53|||||||Repeated Measures Analysis|||||||0.53
91668126|NCT01320722|183230039|SUPERIORITY|||||||0.55|||||||Repeated Measures Analysis|||Awake SBP||||0.55
91668127|NCT01320722|183230039|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||Asleep SBP||||0.80
91668128|NCT01320722|183230040|SUPERIORITY|||||||0.98|||||||Repeated Measures Analysis|||||||0.98
91668129|NCT01320722|183230040|SUPERIORITY|||||||0.07|||||||Repeated Measures Analysis|||||||0.07
91668130|NCT01320722|183230040|SUPERIORITY|||||||0.97|||||||Repeated Measures Analysis|||||||0.97
91668131|NCT01091363|183230041|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.01|TWO_SIDED|95.0|1.67|12.99|||Regression, Logistic|||||12.99|1.67|<0.01
91668132|NCT01091363|183230042|SUPERIORITY_OR_OTHER|Hayes' PROCESS computation tool for a serial multiple mediator model predicting a binary logistic outcome.|Mean Difference (Net)|1.92||||0.02|TWO_SIDED|95.0|0.34|6.32|||Mediation Analysis|||Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes' PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).||6.32|0.34|0.02
91668133|NCT00021541|183230054|SUPERIORITY|||||||0.012|||||||Repeated measures ANOVA|||||||0.012
91668134|NCT00021541|183230054|OTHER|||||||0.015|||||||Repeated measures ANOVA|||Post hoc test: tipifarnib group F=7.40||||0.015
91668135|NCT00021541|183230054|OTHER|||||||0.66|||||||Repeated measures ANOVA|||Post hoc test: placebo group F=0.19||||0.66
91668136|NCT04892147|183230057|OTHER|"Mean value of Enjoyment (8-item summed scale) tested against the value of a Neutral Likert response (Neutral value = 3)."|||||<|0.001||||||The threshold for statistical significance was p = 0.05. The reported value is a calculated -p-value.|t-test, 2 sided|||||||<0.001
91668137|NCT04892147|183230058|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.259||||||The threshold for statistical significance was p = 0.05|Regression, Linear|||||||0.259
91668138|NCT04892147|183230059|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.711||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.711
91668139|NCT04892147|183230060|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.214||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.214
91668140|NCT04892147|183230061|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.317||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.317
91668141|NCT04892147|183230062|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.056||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.056
91668142|NCT04892147|183230063|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.562||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.562
91668143|NCT00556673|183230094|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|||<|0.0001|TWO_SIDED|90.0|0.28|0.51||"Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.~A significance level of 5% was used to determine statistical significance."|1-sided|||The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.||0.51|0.28|< 0.0001
91668144|NCT01971554|183230109|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.8|||||TWO_SIDED|90.0|11.3|50.3|||||A constrained longitudinal data analysis (cLDA) model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||50.3|11.3|
91668145|NCT01971554|183230109|SUPERIORITY_OR_OTHER||Difference in the least squares means|36.0|||||TWO_SIDED|90.0|20.0|51.9|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||51.9|20.0|
91668146|NCT01971554|183230109|SUPERIORITY_OR_OTHER||Difference in the least squares means|54.1|||||TWO_SIDED|90.0|38.1|70.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||70.0|38.1|
91668147|NCT01971554|183230115|SUPERIORITY_OR_OTHER||Difference in the least squares means|22.3|||||TWO_SIDED|90.0|6.2|38.4|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||38.4|6.2|
91668148|NCT01971554|183230115|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.6|||||TWO_SIDED|90.0|17.4|43.8|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||43.8|17.4|
91668149|NCT01971554|183230115|SUPERIORITY_OR_OTHER||Difference in the least squares means|48.8|||||TWO_SIDED|90.0|35.6|62.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||62.0|35.6|
91668150|NCT03505151|183230116|OTHER||Ratio T/R|44.63|STANDARD_ERROR_OF_MEAN|36.9||||90.0|32.62|61.06|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Absolute bioavailability was evaluated using an Analysis of variance model (ANOVA) on BI 409306 AUC0-inf versus 0.1 mg BI 409306 C-13/N-15 i.v. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||61.06|32.62|
91668151|NCT03505151|183230117|OTHER||Ratio T/R|47.25|STANDARD_ERROR_OF_MEAN|68.8||||90.0|27.38|81.55|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Ratios of BI 409306 for Cmax versus 0.1 mg BI 409306 C-13/N-15 i.v. was evaluated using ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||81.55|27.38|
91668152|NCT00087529|183230131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.1442|TWO_SIDED|95.0|0.546|1.093||Stratified using the following variables: Baseline EDSS (less than or equal to \[≤\] 4.0 versus \>4.0 points) and prior treatment with interferon-beta or glatiramer acetate.|Log Rank|||||1.093|0.546|0.1442
91668153|NCT00087529|183230133|SUPERIORITY_OR_OTHER||LS mean difference|-718.24||||0.0008|TWO_SIDED|95.0|-1504.48|68.0|||Friedman ranked ANOVA test|||Treatment difference in least-squares (LS) means and the associated 95% confidence intervals were estimated from the analysis of variance (ANOVA) model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||68.00|-1504.48|0.0008
91668154|NCT00087529|183230134|SUPERIORITY_OR_OTHER||LS mean difference|-1.08||||0.6237|TWO_SIDED|95.0|-9.49|7.34|||Friedman ranked ANOVA test|||Treatment difference in LS means and the associated 95% confidence intervals were estimated from the ANOVA model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||7.34|-9.49|0.6237
91668155|NCT02535923|183230135|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
91668156|NCT02535923|183230135|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
91668157|NCT02535923|183230136|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
91668158|NCT02535923|183230137|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
91668159|NCT02535923|183230138|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||.16
91525850|NCT03502616|182927244|SUPERIORITY||Difference in percentage|3.83|STANDARD_ERROR_OF_MEAN|5.63||0.4971|TWO_SIDED|95.0|-7.22|14.87|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.87|-7.22|0.4971
91484693|NCT01920555|182843336|SUPERIORITY||Mean Difference (Net)|-0.54||||0.54|TWO_SIDED|95.0|-1.25|0.17||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.17|-1.25|0.54
91484694|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.78|0.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.58|-0.78|1.00
91484695|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.03|TWO_SIDED|95.0|-1.64|-0.31||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.31|-1.64|0.03
91484696|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.54|TWO_SIDED|95.0|-1.24|0.11||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.11|-1.24|0.54
91525851|NCT03502616|182927244|SUPERIORITY||Difference in percentage|1.58|STANDARD_ERROR_OF_MEAN|5.65||0.7792|TWO_SIDED|95.0|-9.49|12.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.66|-9.49|0.7792
91525852|NCT03502616|182927244|SUPERIORITY||Difference in percentage|5.22|STANDARD_ERROR_OF_MEAN|5.8||0.3685|TWO_SIDED|95.0|-6.15|16.58|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.58|-6.15|0.3685
91635033|NCT02194699|183163022|SUPERIORITY||LS Mean difference|2.95||||0.1164|TWO_SIDED|95.0|-0.73|6.62|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment||6.62|-0.73|0.1164
91635034|NCT02194699|183163023|SUPERIORITY||LS Mean difference|-0.2||||0.1456|TWO_SIDED|95.0|-0.47|0.07|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.07|-0.47|0.1456
91668160|NCT02535923|183230139|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
91668161|NCT04388787|183230141|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
91668162|NCT04388787|183230142|SUPERIORITY|||||||0.0008|||||||ANCOVA|||||||0.0008
91668163|NCT04662710|183230155|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0244|TWO_SIDED|95.0|0.71|1.0||One-sided p-value based on log-rank test stratified by region, ECOG performance status, and chemotherapy type|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy type|||1.00|0.71|.0244
91668164|NCT04662710|183230156|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.033|TWO_SIDED|95.0|0.75|1.01||One-sided p-value based on log-rank test stratified by region, ECOG performance status and chemotherapy type.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy|||1.01|0.75|0.0330
91668165|NCT04662710|183230157|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0012|TWO_SIDED|95.0|0.62|0.9||One-sided p-value based on log-rank test stratified by region, performance status, and chemotherapy type|Log Rank||HR Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy type.|||0.90|0.62|.0012
91714505|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|5.26||0.5593||95.0|-13.4|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.4|0.5593
91668166|NCT04662710|183230158|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0019|TWO_SIDED|95.0|0.66|0.92||One-sided p-value based on log-rank test stratified by region, ECOG performance status, and chemotherapy type.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy type.|||0.92|0.66|0.0019
91668167|NCT04662710|183230159|SUPERIORITY||Difference in Percentage|14.3|||<|0.0001|TWO_SIDED|95.0|6.9|21.5|||t-test, 1 sided|||ORR comparison between groups is based on Miettinen \& Nurminen method stratified by region, ECOG performance status, and type of chemotherapy||21.5|6.9|<0.0001
91668168|NCT04662710|183230160|SUPERIORITY||Difference in Percentage|14.2|||<|0.0001|TWO_SIDED|95.0|7.7|20.6|||t-test, 1 sided|||ORR comparison between groups is based on Miettinen \& Nurminen method stratified by region, ECOG performance status, and type of chemotherapy||20.6|7.7|<0.0001
91525853|NCT03502616|182927245|SUPERIORITY||Difference in percentage|6.12|STANDARD_ERROR_OF_MEAN|3.19||0.0548|TWO_SIDED|95.0|-0.13|12.37|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.37|-0.13|0.0548
91635035|NCT02194699|183163023|SUPERIORITY||LS Mean difference|0.04||||0.6548|TWO_SIDED|95.0|-0.13|0.2|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.20|-0.13|0.6548
91635036|NCT02194699|183163023|SUPERIORITY||LS Mean difference|-0.04||||0.5763|TWO_SIDED|95.0|-0.18|0.1|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.10|-0.18|0.5763
91635037|NCT02194699|183163024|SUPERIORITY||LS Mean difference|0.27||||0.0874|TWO_SIDED|95.0|-0.04|0.57|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.57|-0.04|0.0874
91668169|NCT01453153|183230237|SUPERIORITY||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|60.0||||||||60|0|
91668170|NCT01453153|183230237|SUPERIORITY||percentage of participants|50.0|||||TWO_SIDED|95.0|7.0|93.0||||||||93|7|
91668171|NCT01453153|183230237|SUPERIORITY||percentage of participants|40.0|||||TWO_SIDED|95.0|19.0|64.0||||||||64|19|
91668172|NCT01453153|183230238|SUPERIORITY||percentage of participants|25.0|||||TWO_SIDED|95.0|1.0|81.0||||||||81|1|
91668173|NCT01453153|183230238|SUPERIORITY||percentage of participants|100.0|||||TWO_SIDED|95.0|40.0|100.0||||||||100|40|
91792574|NCT02129777|183462756|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.043||0.57|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.11|0.570
91668174|NCT01453153|183230238|SUPERIORITY||percentage of participants|70.0|||||TWO_SIDED|95.0|46.0|88.0||||||||88|46|
91668175|NCT01196117|183230245|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||||||0.0009
91668176|NCT01196117|183230246|SUPERIORITY|||||||0.8938|||||||Wilcoxon (Mann-Whitney)|||||||0.8938
91668177|NCT01196117|183230247|SUPERIORITY||||||<|0.014|||||||Wilcoxon (Mann-Whitney)|||||||<0.014
91668178|NCT01196117|183230248|SUPERIORITY||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|||||||<0.0200
91668179|NCT01196117|183230249|SUPERIORITY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||||||0.1321
91668180|NCT01196117|183230250|SUPERIORITY||||||<|0.249|||||||Wilcoxon (Mann-Whitney)|||||||<0.2490
91668181|NCT01196117|183230251|SUPERIORITY|||||||0.5139|||||||Wilcoxon (Mann-Whitney)|||||||0.5139
91668182|NCT01196117|183230252|SUPERIORITY|||||||0.0597|||||||Wilcoxon (Mann-Whitney)|||||||0.0597
91668183|NCT01196117|183230253|SUPERIORITY|||||||0.2134|||||||Wilcoxon (Mann-Whitney)|||||||0.2134
91668184|NCT02274558|183230303|OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.2|-2.0|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): valbenazine 80 mg vs. placebo.~* CGI-TD mean score: VBZ 80 mg vs. PBO.~* AIMS: VBZ 40 mg vs. PBO.~* CGI-TD: VBZ 40 mg vs. PBO.~For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.0|-4.2|<0.0001
91668185|NCT02274558|183230303|OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.0021|TWO_SIDED|95.0|-3.0|-0.7||Nominal P-value, not adjusted for multiplicity. See comments in above statistical analysis overview regarding the fixed-sequence testing procedure to control for multiplicity.|Mixed-effect Model Repeated Measures|||||-0.7|-3.0|0.0021
91668186|NCT02274558|183230304|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0742|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0742
91668187|NCT02274558|183230304|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.056|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0560
91668188|NCT02274558|183230305|OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.0200
91668189|NCT02274558|183230305|OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91792575|NCT02129777|183462756|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.619|TWO_SIDED|95.0|-0.1|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.10|0.619
91484697|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.19||||1|TWO_SIDED|95.0|-0.96|0.57||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.57|-0.96|1.00
91635038|NCT02194699|183163024|SUPERIORITY||LS Mean difference|-0.01||||0.9083|TWO_SIDED|95.0|-0.2|0.17|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.17|-0.20|0.9083
91635039|NCT02194699|183163024|SUPERIORITY||LS Mean difference|0.06||||0.4506|TWO_SIDED|95.0|-0.1|0.22|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.22|-0.10|0.4506
91635040|NCT02194699|183163025|SUPERIORITY||LS Mean difference|-0.27||||0.04|TWO_SIDED|95.0|-0.53|-0.01|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.01|-0.53|0.0400
91635041|NCT02194699|183163025|SUPERIORITY||LS Mean difference|0.0||||0.9735|TWO_SIDED|95.0|-0.16|0.16|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.16|-0.16|0.9735
91635042|NCT02194699|183163025|SUPERIORITY||LS Mean difference|-0.08||||0.2432|TWO_SIDED|95.0|-0.21|0.05|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.05|-0.21|0.2432
91635043|NCT02194699|183163026|SUPERIORITY||Rate ratio|0.39||||0.0576|TWO_SIDED|95.0|0.15|1.03|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.03|0.15|0.0576
91635044|NCT02194699|183163026|SUPERIORITY||Rate ratio|0.83||||0.5249|TWO_SIDED|95.0|0.46|1.48|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.48|0.46|0.5249
91635045|NCT02194699|183163026|SUPERIORITY||Rate ratio|0.67||||0.1155|TWO_SIDED|95.0|0.41|1.1|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.||1.10|0.41|0.1155
91635046|NCT02194699|183163028|SUPERIORITY||LS Mean difference|-0.95||||0.036|TWO_SIDED|95.0|-1.85|-0.06|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.06|-1.85|0.0360
91792576|NCT02129777|183462756|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.597|TWO_SIDED|95.0|-0.06|0.11|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.11|-0.06|0.597
91635047|NCT02194699|183163028|SUPERIORITY||LS Mean difference|0.15||||0.5864|TWO_SIDED|95.0|-0.4|0.7|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.70|-0.40|0.5864
91635048|NCT02194699|183163028|SUPERIORITY||LS Mean difference|-0.17||||0.4689|TWO_SIDED|95.0|-0.63|0.29|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.63|0.4689
91635049|NCT02194699|183163029|SUPERIORITY||LS Mean difference|6.15||||0.5094|TWO_SIDED|95.0|-12.13|24.43|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||24.43|-12.13|0.5094
91635050|NCT02194699|183163029|SUPERIORITY||LS Mean difference|3.02||||0.5984|TWO_SIDED|95.0|-8.22|14.26|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.26|-8.22|0.5984
91635051|NCT02194699|183163029|SUPERIORITY||LS Mean difference|7.84||||0.3971|TWO_SIDED|95.0|-10.32|26.0|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||26.00|-10.32|0.3971
91635052|NCT02194699|183163029|SUPERIORITY||LS Mean difference|3.59||||0.531|TWO_SIDED|95.0|-7.65|14.83|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.83|-7.65|0.5310
91635053|NCT02194699|183163029|SUPERIORITY||LS Mean difference|3.46||||0.4764|TWO_SIDED|95.0|-6.06|12.97|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||12.97|-6.06|0.4764
91635054|NCT02194699|183163029|SUPERIORITY||LS Mean difference|3.88||||0.4221|TWO_SIDED|95.0|-5.6|13.37|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||13.37|-5.60|0.4221
91668190|NCT00323258|183230346|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the treatment arm compared to those who receive usual care."||||||0.5|||||||Chi-squared|||Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.||||.50
91668191|NCT00323258|183230347|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to combined beta-blocker and statin therapy in the treatment arm compared to those who receive usual care."|||||=|0.11|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||=0.11
91484698|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.21||||1|TWO_SIDED|95.0|-0.93|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-0.93|1.00
91484699|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.52|TWO_SIDED|95.0|-1.35|0.06||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.06|-1.35|0.52
91484700|NCT01920555|182843336|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.54|TWO_SIDED|95.0|-1.33|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-1.33|0.54
91635055|NCT02194699|183163030|SUPERIORITY||LS Mean difference|-5.04||||0.1099|TWO_SIDED|95.0|-11.21|1.14|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||1.14|-11.21|0.1099
91668192|NCT00323258|183230348|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to beta-blockers in the treatment arm compared to those who receive usual care."||||||0.03|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.03
91668193|NCT00323258|183230349|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to statins in the treatment arm compared to those who receive usual care."||||||0.34|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.34
91668194|NCT01728636|183230351|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
91668195|NCT01097694|183230387|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed.~The target enrollment was 60 assuming 10% drop-out for 54 completions which gave us 80% power to detect a doubling-dose change in PC20."||||<0.05
91668196|NCT01097694|183230388|SUPERIORITY||||||<|0.05|||||||Regression, Linear|Adjusted for baseline.||||||<0.05
91668197|NCT01097694|183230389|SUPERIORITY|||||||0.12|||||||Regression, Linear|Adjusted for baseline.||||||0.12
91668198|NCT01097694|183230390|SUPERIORITY|||||||0.1|||||||Regression, Linear|Adjusted for baseline.||||||0.10
91525854|NCT03502616|182927245|SUPERIORITY||Difference in percentage|23.43|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|15.3|31.56|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.56|15.30|<0.0001
91668199|NCT01097694|183230391|SUPERIORITY|||||||0.36|||||||Poisson regression model|||||||0.36
91668200|NCT01097694|183230392|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|adjusted for baseline values||For FEV1 we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||<0.05
91668201|NCT01097694|183230393|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Adjusted for baseline.||For FEV1% we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||0.06
91668202|NCT01097694|183230394|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|Adjusted for baseline||||||0.38
91668203|NCT01097694|183230395|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Adjusted for baseline.||||||0.31
91668204|NCT01097694|183230396|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
91668205|NCT01097694|183230397|SUPERIORITY|||||||0.31|||||||Regression, Linear|Adjusted for baseline.||||||0.31
91668206|NCT01097694|183230398|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
91668207|NCT01097694|183230399|SUPERIORITY|||||||0.62|||||||Regression, Linear|Adjusted for baseline.||||||0.62
91668208|NCT01097694|183230400|SUPERIORITY|||||||0.57|||||||Regression, Linear|Adjusted for baseline.||||||0.57
91668209|NCT01097694|183230401|SUPERIORITY|||||||0.15|||||||Regression, Linear|Adjusted for baseline||||||0.15
91668210|NCT01097694|183230402|SUPERIORITY|||||||0.33|||||||Regression, Linear|Adjusted for baseline.||||||0.33
91668211|NCT01097694|183230403|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline.||||||0.11
91792577|NCT02129777|183462756|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.509|TWO_SIDED|95.0|-0.06|0.12|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.12|-0.06|0.509
91792578|NCT02129777|183462757|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.32||0.845|TWO_SIDED|95.0|-11.7|9.6|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||9.6|-11.7|0.845
91525855|NCT03502616|182927245|SUPERIORITY||Difference in percentage|28.56|STANDARD_ERROR_OF_MEAN|4.54|<|0.0001|TWO_SIDED|95.0|19.66|37.47|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.47|19.66|<0.0001
91635056|NCT02194699|183163030|SUPERIORITY||LS Mean difference|0.46||||0.8112|TWO_SIDED|95.0|-3.33|4.25|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||4.25|-3.33|0.8112
91635057|NCT02194699|183163030|SUPERIORITY||LS Mean difference|-1.19||||0.4645|TWO_SIDED|95.0|-4.4|2.01|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||2.01|-4.40|0.4645
91635058|NCT02194699|183163031|SUPERIORITY||Odds Ratio (OR)|0.77||||0.344|TWO_SIDED|95.0|0.44|1.33|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.||1.33|0.44|0.3440
91635059|NCT02194699|183163031|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7768|TWO_SIDED|95.0|0.75|1.46|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.||1.46|0.75|0.7768
91635060|NCT02194699|183163031|SUPERIORITY||Odds Ratio (OR)|0.91||||0.5276|TWO_SIDED|95.0|0.69|1.21|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.||1.21|0.69|0.5276
91635061|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.596||||0.0045|TWO_SIDED|95.0|1.704|18.378|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\] 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||18.378|1.704|0.0045
91635062|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.989||||0.9755|TWO_SIDED|95.0|0.497|1.967|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.967|0.497|0.9755
91635063|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.4786|TWO_SIDED|95.0|0.327|1.688|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.688|0.327|0.4786
91635064|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38||||0.014|TWO_SIDED|95.0|1.405|20.597|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.597|1.405|0.0140
91668212|NCT01097694|183230404|SUPERIORITY|||||||0.07|||||||Regression, Linear|Adjusted for baseline.||||||0.07
91668213|NCT01097694|183230405|SUPERIORITY|||||||0.94|||||||Regression, Linear|Adjusted for baseline.||||||0.94
91668214|NCT01097694|183230406|SUPERIORITY|||||||0.13|||||||Regression, Linear|Adjusted for baseline||||||0.13
91668215|NCT01097694|183230407|SUPERIORITY|||||||0.25|||||||Regression, Linear|Adjusted for baseline||||||0.25
91668216|NCT01097694|183230408|SUPERIORITY|||||||0.54|||||||Regression, Linear|Adjusted for baseline.||||||0.54
91668217|NCT01097694|183230409|SUPERIORITY|||||||0.18|||||||Regression, Linear|Adjusted for baseline.||||||0.18
91668218|NCT01097694|183230410|SUPERIORITY|||||||0.56|||||||Regression, Linear|Adjusted for baseline.||||||0.56
91668219|NCT01097694|183230411|SUPERIORITY|||||||0.47|||||||Regression, Linear|Adjusted for baseline.||||||0.47
91484701|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.74|TWO_SIDED|95.0|-0.79|0.08||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.08|-0.79|0.74
91484702|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-0.37|0.45||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.45|-0.37|1.00
91484703|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.01|-0.21||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.21|-1.01|0.02
91484704|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.8|TWO_SIDED|95.0|-0.72|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-0.72|0.80
91525856|NCT03502616|182927245|SUPERIORITY||Difference in percentage|31.18|STANDARD_ERROR_OF_MEAN|5.02|<|0.0001|TWO_SIDED|95.0|21.34|41.02|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.02|21.34|<0.0001
91525857|NCT03502616|182927245|SUPERIORITY||Difference in percentage|6.29|STANDARD_ERROR_OF_MEAN|5.98||0.2926|TWO_SIDED|95.0|-5.43|18.01|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.01|-5.43|0.2926
91525858|NCT03502616|182927245|SUPERIORITY||Difference in percentage|6.37|STANDARD_ERROR_OF_MEAN|5.97||0.2856|TWO_SIDED|95.0|-5.32|18.06|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.06|-5.32|0.2856
91635065|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.062|1.094|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.094|1.062|<0.0001
91635066|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.136||||0.0035|TWO_SIDED|95.0|1.819|20.701|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.701|1.819|0.0035
91635067|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.7821|TWO_SIDED|95.0|0.439|1.857|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.857|0.439|0.7821
91635068|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.4846|TWO_SIDED|95.0|0.317|1.723|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.723|0.317|0.4846
91668220|NCT05068661|183230451|SUPERIORITY||Risk Ratio (RR)|0.75||||0.486|TWO_SIDED|95.0|0.4|1.39|||Chi-squared|||||1.39|0.40|0.486
91668221|NCT05068661|183230452|SUPERIORITY||Risk Ratio (RR)|0.85||||0.148|TWO_SIDED|95.0|0.69|1.06||This is adjusted P value for hypotension|Chi-squared|||||1.06|0.69|0.148
91668222|NCT05068661|183230453|SUPERIORITY||Risk Ratio (RR)|1.04|||>|0.999|TWO_SIDED|95.0|0.98|1.1||This is adjusted P value|Chi-squared|||||1.10|0.98|>0.999
91792579|NCT02129777|183462757|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|4.8||0.323|TWO_SIDED|95.0|-4.8|14.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.4|-4.8|0.323
91668223|NCT05068661|183230454|SUPERIORITY||Mean Ratio|1.9||||0.128|TWO_SIDED|95.0|1.14|3.18||Adjusted P value|Regression, Linear|||||3.18|1.14|0.128
91484705|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.88|TWO_SIDED|95.0|-0.83|0.18||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.18|-0.83|0.88
91525859|NCT03502616|182927245|SUPERIORITY||Difference in percentage|7.83|STANDARD_ERROR_OF_MEAN|5.97||0.1894|TWO_SIDED|95.0|-3.87|19.54|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||19.54|-3.87|0.1894
91668224|NCT05068661|183230455|SUPERIORITY||Mean Ratio|1.04|||>|0.999|TWO_SIDED|95.0|0.8|1.35||Adjusted P value|Regression, Linear|||||1.35|0.80|>0.999
91668225|NCT05068661|183230456|SUPERIORITY||Mean Ratio|0.97|||>|0.999|TWO_SIDED|95.0|0.93|1.3||Adjusted P value|Regression, Linear|||||1.30|0.93|>0.999
91668226|NCT05068661|183230457|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.999|TWO_SIDED|95.0|0.52|1.25||Adjusted P value|Chi-squared|||||1.25|0.52|>0.999
91668227|NCT05068661|183230458|SUPERIORITY||Risk Ratio (RR)|0.85|||>|0.999|TWO_SIDED|95.0|0.58|1.24||Adjusted P value|Chi-squared|||||1.24|0.58|>0.999
91668228|NCT05068661|183230459|SUPERIORITY||Mean Ratio|1.03|||>|0.999|TWO_SIDED|95.0|0.86|1.22||Adjusted P value|Regression, Linear|||||1.22|0.86|>0.999
91668229|NCT01567527|183230460|SUPERIORITY||Hazard Ratio (HR)|0.451|||<|0.0001|TWO_SIDED|95.0|0.299|0.678|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|Significance level 0.05.||0.678|0.299|< 0.0001
91668230|NCT01567527|183230460|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|2.22|||||TWO_SIDED|95.0|1.475|3.34|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||3.34|1.475|
91668231|NCT01567527|183230461|SUPERIORITY|Using a hierarchical procedure to preserve the overall Type I error rate at 0.05, after testing the primary outcome.|Percentage Difference (Final Values)|-24.6|||<|0.0001|TWO_SIDED|95.0|-36.7|-12.5|||Fisher Exact|||Statistical analysis for any mood episode||-12.5|-36.7|< 0.0001
91668232|NCT01567527|183230462|SUPERIORITY|Using mixed model repeated measures (MMRM) analysis with a restricted maximum likelihood (REML) approach. Analyses included the categorically fixed effects of treatment, region, trial week, and treatment-by-week interaction, as well as the continuously fixed covariates of baseline-score-by-week interaction. An unstructured covariance structure was used to model the within-subject errors and Kenward-Rodger degree of freedom was used to test the fixed effects.|Mean Difference (Final Values)|-0.43|||=|0.0011|TWO_SIDED|95.0|-0.69|-0.17|||Mixed model repeated measure analysis|||||-0.17|-0.69|= 0.0011
91714506|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.97||0.8663||95.0|-8.9|10.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-8.9|0.8663
91714507|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|5.12||0.119||95.0|-2.1|18.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.1|-2.1|0.1190
91668233|NCT01567527|183230463|SUPERIORITY||Hazard Ratio (HR)|0.137|||=|0.0002|TWO_SIDED|95.0|0.04|0.465|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|||0.465|0.04|= 0.0002
91668234|NCT01567527|183230463|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|7.313|||||TWO_SIDED|95.0|2.151|24.865|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||24.865|2.151|
91668235|NCT02004691|183230465|SUPERIORITY||Least Squares Mean Difference|19.008|STANDARD_ERROR_OF_MEAN|4.7576|=|0.0004|TWO_SIDED|95.0|9.319|28.696||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% Confidence Interval (CI) and p-values were based on mixed model for repeated measures approach with Baseline Derived % Predicted DLco adjusted for Hb and pressure, age, treatment group, visit, and study visit by treatment group as covariates.|||28.696|9.319|=0.0004
91668236|NCT02004691|183230467|SUPERIORITY||Least Squares Mean Difference|-39.927|STANDARD_ERROR_OF_MEAN|3.4957|<|0.0001|TWO_SIDED|95.0|-47.051|-32.803||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values were based on a mixed model for repeated measures approach with Baseline Spleen Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||-32.803|-47.051|<.0001
91668237|NCT02004691|183230469|SUPERIORITY||Least Squares Mean Difference|1.618|STANDARD_ERROR_OF_MEAN|3.3877|=|0.6364|TWO_SIDED|95.0|-5.302|8.538||Threshold for significance was 0.15.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Splenomegaly Related Score, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||8.538|-5.302|=0.6364
91668238|NCT02004691|183230474|SUPERIORITY||Least Squares Mean Difference|-26.596|STANDARD_ERROR_OF_MEAN|3.5862|<|0.0001|TWO_SIDED|95.0|-33.911|-19.281||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Liver Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||-19.281|-33.911|<.0001
91484706|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.05||||1|TWO_SIDED|95.0|-0.53|0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.44|-0.53|1.00
91484707|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.88|TWO_SIDED|95.0|-0.79|0.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.15|-0.79|0.88
91525860|NCT03502616|182927245|SUPERIORITY||Difference in percentage|5.59|STANDARD_ERROR_OF_MEAN|6.04||0.3544|TWO_SIDED|95.0|-6.24|17.43|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||17.43|-6.24|0.3544
91668239|NCT02004691|183230475|SUPERIORITY||Least Squares Mean Difference|14.332|STANDARD_ERROR_OF_MEAN|5.7822|=|0.0185|TWO_SIDED|95.0|2.564|26.099||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Platelets, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||26.099|2.564|=0.0185
91668240|NCT02004691|183230476|SUPERIORITY||Least Squares Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.7384|=|0.94|TWO_SIDED|95.0|-1.566|1.454||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline BFI item 3 (Worst Fatigue), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||1.454|-1.566|=0.9400
91668241|NCT03407729|183230497|OTHER|Using seed-based analysis with a 1) Left Thalamus seed and 2) Left Middle Temporal Gyrus seed, cluster size was set at 50 voxels and p-value was thresholded at p\<0.05. This was used to compare the differences between the two study groups in terms of number of activated voxels during during cognitive testing using the N-back.|||||<|0.05||||||The a priori threshold for statistical significance was p\<0.05 and statistical power was set at a minimum of 0.80.|t-test, 2 sided|||||||<0.05
91668242|NCT01849458|183230500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.6|STANDARD_DEVIATION|26.0||0.0001|TWO_SIDED|95.0|25.2|40.0|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||40|25.2|0.0001
91668243|NCT01849458|183230501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.7|STANDARD_DEVIATION|23.6||0.0001|TWO_SIDED|95.0|28.7|42.7|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||42.7|28.7|0.0001
91668244|NCT01849458|183230502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|22.2||0.0001|TWO_SIDED|95.0|37.4|50.1|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||50.1|37.4|0.0001
91668245|NCT01849458|183230503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|20.2||0.0001|TWO_SIDED|95.0|43.2|55.2|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||55.2|43.2|0.0001
91668246|NCT04387617|183230506|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.6||0.5|TWO_SIDED|95.0|-0.8|1.6|||t-test, 2 sided|||||1.6|-0.8|0.5
91668247|NCT03950674|183230516|OTHER||Hazard Ratio (HR)|0.62||||0.12511|TWO_SIDED|95.0|0.27|1.42||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.42|0.27|0.12511
91668248|NCT03950674|183230517|OTHER||Hazard Ratio (HR)|0.29||||0.03127|TWO_SIDED|95.0|0.07|1.15||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.15|0.07|0.03127
91668249|NCT00830167|183230525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.78|-0.11||The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O'Brien-Fleming type alpha spending function of Lan and DeMets (1983).|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.11|-0.78|0.0046
91668250|NCT00830167|183230526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED|||||The analysis was conducted using 2-sided test with the significance level of 0.05.|Chi-squared|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.||||0.0078
91668251|NCT00830167|183230527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.12|-5.85||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-5.85|-13.12|<0.0001
91484708|NCT01920555|182843337|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.88|TWO_SIDED|95.0|-0.76|0.19||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.19|-0.76|0.88
91635069|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.424||||0.017|TWO_SIDED|95.0|1.353|21.749|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.749|1.353|0.0170
91635070|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.695||||0.0125|TWO_SIDED|95.0|0.523|0.925|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.925|0.523|0.0125
91635071|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.472||||0.0139|TWO_SIDED|95.0|1.288|9.357|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||9.357|1.288|0.0139
91635072|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.6327|TWO_SIDED|95.0|0.601|2.311|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (\> 1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.311|0.601|0.6327
91668252|NCT00830167|183230528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|1.88||0.9958|TWO_SIDED|95.0|1.29|8.68||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||8.68|1.29|0.9958
91668253|NCT00830167|183230529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|1.92||0.0049|TWO_SIDED|95.0|-8.77|-1.21||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-1.21|-8.77|0.0049
91668254|NCT00830167|183230530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.09||0.0007|TWO_SIDED|95.0|0.11|0.47||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.47|0.11|0.0007
91668255|NCT00830167|183230531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|3.58|11.38||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||11.38|3.58|<0.0001
91668256|NCT00830167|183230532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.31|STANDARD_ERROR_OF_MEAN|1.82||1|TWO_SIDED|95.0|7.74|14.87||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||14.87|7.74|1.0000
91525861|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.85|-0.57|||Mixed Models Analysis|||Week 2: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.57|-0.85|<0.0001
91635073|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.061|||<|0.0001|TWO_SIDED|95.0|1.042|1.08|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.080|1.042|<0.0001
91635074|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.0033|TWO_SIDED|95.0|1.058|1.326|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.326|1.058|0.0033
91668257|NCT00830167|183230533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.35||0.0137|TWO_SIDED|95.0|-5.65|-0.33||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.33|-5.65|0.0137
91668258|NCT00830167|183230534|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0687|TWO_SIDED|95.0|0.9|2.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|Regression, Logistic|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||2.35|0.90|0.0687
91484709|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|11.18||||0.49|TWO_SIDED|95.0|-0.94|23.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||23.29|-0.94|0.49
91668259|NCT00830167|183230535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.40|-1.06|<0.0001
91668260|NCT00830167|183230536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.52||0.0144|TWO_SIDED|95.0|-6.31|-0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.35|-6.31|0.0144
91668261|NCT00830167|183230537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0376|TWO_SIDED|95.0|-0.59|0.03||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.03|-0.59|0.0376
91668262|NCT00830167|183230538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.0052|TWO_SIDED|95.0|-1.12|-0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.15|-1.12|0.0052
91714508|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.15||0.1544||95.0|-2.8|17.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.5|-2.8|0.1544
91484710|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|1.37||||1|TWO_SIDED|95.0|-10.19|12.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||12.93|-10.19|1.00
91484711|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|16.54||||0.03|TWO_SIDED|95.0|5.31|27.77||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||27.77|5.31|0.03
91484712|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|8.68||||0.82|TWO_SIDED|95.0|-2.81|20.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.16|-2.81|0.82
91484713|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|5.11||||1|TWO_SIDED|95.0|-8.83|19.05||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||19.05|-8.83|1.00
91668263|NCT00830167|183230539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.4768|TWO_SIDED|95.0|-0.42|0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.40|-0.42|0.4768
91668264|NCT00830167|183230540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.0729|TWO_SIDED|95.0|-0.74|0.11||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.11|-0.74|0.0729
91484714|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|-6.64||||1|TWO_SIDED|95.0|-19.87|6.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||6.59|-19.87|1.00
91484715|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|7.64||||1|TWO_SIDED|95.0|-5.26|20.53||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.53|-5.26|1.00
91484716|NCT01920555|182843338|SUPERIORITY||Mean Difference (Final Values)|4.8||||1|TWO_SIDED|95.0|-8.31|17.91||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||17.91|-8.31|1.00
91484717|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|-1.21||||1|TWO_SIDED|95.0|-3.99|1.56||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.56|-3.99|1.00
91484718|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.17|TWO_SIDED|95.0|-1.9|3.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||3.43|-1.90|0.17
91484719|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.3|TWO_SIDED|95.0|-5.32|-0.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.16|-5.32|0.30
91484720|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|-0.71||||1|TWO_SIDED|95.0|-3.35|1.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.93|-3.35|1.00
91484721|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|-0.29||||1|TWO_SIDED|95.0|-3.25|2.66||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.66|-3.25|1.00
91484722|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|2.76||||0.39|TWO_SIDED|95.0|-0.06|5.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||5.59|-0.06|0.39
91484723|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|-1.17||||1|TWO_SIDED|95.0|-3.91|1.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.58|-3.91|1.00
91484724|NCT01920555|182843339|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1|TWO_SIDED|95.0|-3.22|2.35||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.35|-3.22|1.00
91484725|NCT00195273|182843343|SUPERIORITY_OR_OTHER|||||||0.6081||||||Calculated for 12 month analysis|ANOVA|Analysis of variance with treatment group and center as factors||||||0.6081
91484726|NCT00195273|182843346|SUPERIORITY_OR_OTHER|||||||0.4662|||||||ANOVA|Calculated for 3 month analysis||||||0.4662
91484727|NCT00810108|182843437|NON_INFERIORITY_OR_EQUIVALENCE|The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.|Ratio of Crushed/Whole Tablet AUC|0.55|||<|0.05|TWO_SIDED|90.0|0.45|0.69|||t-test, 2 sided|||Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.||0.69|0.45|<0.05
91484728|NCT01288027|182843466|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||one sample t-test|||Statistical significance for change from Baseline was measured using one sample t-test||||0.1860
91484729|NCT02556203|182843475|NON_INFERIORITY|1-sided Confidence interval|Hazard Ratio (HR)|1.2089302|||||ONE_SIDED|97.5||1.7040824||||||"H0: HR(t)\>=1.20 for all time points t\>=0, (i.e. the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group)"||1.7040824||
91484730|NCT02556203|182843476|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.35|||=|0.04223|TWO_SIDED|95.0|1.01|1.81|||Log Rank|||||1.81|1.01|= 0.04223
91484731|NCT02556203|182843477|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.5|||=|0.07745|TWO_SIDED|95.0|0.95|2.37|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.37|0.95|= 0.07745
91484732|NCT02556203|182843478|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.39|||=|0.01156|TWO_SIDED|95.0|1.08|1.8|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.80|1.08|= 0.01156
91484733|NCT02556203|182843479|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.22|||=|0.21595|TWO_SIDED|95.0|0.89|1.69|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.69|0.89|= 0.21595
91484734|NCT02556203|182843480|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.78|||=|0.02216|TWO_SIDED|95.0|1.08|2.94|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.94|1.08|= 0.02216
91484735|NCT02556203|182843481|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.66|||=|0.02702|TWO_SIDED|95.0|1.05|2.62|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.62|1.05|= 0.02702
91484736|NCT02556203|182843482|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.84|||=|1e-05|TWO_SIDED|95.0|1.41|2.41|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.41|1.41|= 0.00001
91484737|NCT00739999|182843483|SUPERIORITY_OR_OTHER_LEGACY||Atorvastatin CL/F based on 70 kg BW|699.0|||||TWO_SIDED|95.0|570.0|881.0|||non-linear mixed-effects model|Measures of parameter estimation uncertainty (95% CI) were determined by non-parametric bootstrap analysis.||Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.||881|570|
91484738|NCT00369122|182843511|OTHER||||||||||||||||||Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate \>=20% and AE rate \>=55% excessive. If there were \>=6 pts with SAES or \>=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|||
91484739|NCT03633617|182843519|SUPERIORITY||Difference in proportion|55.3|||<|0.0001|TWO_SIDED|95.0|39.58|71.04|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||71.04|39.58|<0.0001
91484740|NCT03633617|182843519|SUPERIORITY||Difference in proportion|56.0|||<|0.0001|TWO_SIDED|95.0|43.44|68.54|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||68.54|43.44|<0.0001
91484741|NCT03633617|182843519|SUPERIORITY||Difference in proportion|53.5|||<|0.0001|TWO_SIDED|95.0|41.2|65.79|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||65.79|41.20|<0.0001
91484742|NCT03633617|182843520|SUPERIORITY||LS Mean Difference|-12.32||||0.0004|TWO_SIDED|95.0|-19.107|-5.537|||ANCOVA||Dupilumab group vs. Placebo|||-5.537|-19.107|0.0004
91484743|NCT03633617|182843520|SUPERIORITY||LS Mean Difference|-0.51||||0.8393|TWO_SIDED|95.0|-5.423|4.406|||ANCOVA||Dupilumab group vs. Placebo|||4.406|-5.423|0.8393
91484744|NCT03633617|182843520|SUPERIORITY||LS Mean Difference|-9.92|||<|0.0001|TWO_SIDED|95.0|-14.811|-5.022|||ANCOVA||Dupilumab group vs. Placebo|||-5.022|-14.811|<0.0001
91484745|NCT03633617|182843521|SUPERIORITY||LS Mean Difference|-68.26|||<|0.0001|TWO_SIDED|95.0|-86.896|-49.615|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-49.615|-86.896|<0.0001
91484746|NCT03633617|182843521|SUPERIORITY||LS Mean Difference|-79.22|||<|0.0001|TWO_SIDED|95.0|-103.098|-55.338|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-55.338|-103.098|<0.0001
91484747|NCT03633617|182843521|SUPERIORITY||LS Mean Difference|-88.62|||<|0.0001|TWO_SIDED|95.0|-112.194|-65.046|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-65.046|-112.194|<0.0001
91484748|NCT03633617|182843522|SUPERIORITY||LS Mean Difference|-37.48||||0.0002|TWO_SIDED|95.0|-57.222|-17.745|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-17.745|-57.222|0.0002
91484749|NCT03633617|182843522|SUPERIORITY||LS Mean Difference|-4.35||||0.5243|TWO_SIDED|95.0|-17.734|9.038|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||9.038|-17.734|0.5243
91484750|NCT03633617|182843522|SUPERIORITY||LS Mean Difference|-22.89||||0.0008|TWO_SIDED|95.0|-36.272|-9.513|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-9.513|-36.272|0.0008
91668265|NCT00830167|183230541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.0238|TWO_SIDED|95.0|-0.81|0.0||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.00|-0.81|0.0238
91484751|NCT03633617|182843523|SUPERIORITY||LS Mean Difference|-0.759|||<|0.0001|TWO_SIDED|95.0|-0.9061|-0.6127|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.6127|-0.9061|<0.0001
91484752|NCT03633617|182843523|SUPERIORITY||LS Mean Difference|-0.666|||<|0.0001|TWO_SIDED|95.0|-0.7773|-0.5538|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5538|-0.7773|<0.0001
91484753|NCT03633617|182843523|SUPERIORITY||LS Mean Difference|-0.682|||<|0.0001|TWO_SIDED|95.0|-0.7929|-0.5707|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5707|-0.7929|<0.0001
91484754|NCT03633617|182843524|SUPERIORITY||LS Mean Difference|-0.741|||<|0.0001|TWO_SIDED|95.0|-0.8842|-0.5978|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5978|-0.8842|<0.0001
91484755|NCT03633617|182843524|SUPERIORITY||LS Mean Difference|-0.661|||<|0.0001|TWO_SIDED|95.0|-0.7674|-0.554|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5540|-0.7674|<0.0001
91484756|NCT03633617|182843524|SUPERIORITY||LS Mean Difference|-0.672|||<|0.0001|TWO_SIDED|95.0|-0.7778|-0.5655|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5655|-0.7778|<0.0001
91484757|NCT03633617|182843525|SUPERIORITY||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-1.84|-3.91|<0.0001
91484758|NCT03633617|182843525|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-4.86|-3.02|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-3.02|-4.86|<0.0001
91484759|NCT03633617|182843525|SUPERIORITY||LS Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.77|-2.93|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-2.93|-4.77|<0.0001
91484760|NCT03633617|182843526|SUPERIORITY||Difference in proportion|57.5|||<|0.0001|TWO_SIDED|95.0|41.69|73.33|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||73.33|41.69|<0.0001
91484761|NCT03633617|182843526|SUPERIORITY||Difference in proportion|72.4|||<|0.0001|TWO_SIDED|95.0|61.05|83.7|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||83.70|61.05|<0.0001
91484762|NCT03633617|182843526|SUPERIORITY||Difference in proportion|74.9|||<|0.0001|TWO_SIDED|95.0|64.25|85.5|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||85.50|64.25|<0.0001
91484763|NCT03633617|182843527|SUPERIORITY||Hodges-Lehmann estimator|-2.25|||<|0.0001|TWO_SIDED|95.0|-2.72|-1.73|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.7300|-2.7200|<0.0001
91484764|NCT03633617|182843527|SUPERIORITY||Hodges-Lehmann estimator|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.42|-1.11|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1100|-2.4200|<0.0001
91484765|NCT03633617|182843527|SUPERIORITY||Hodges-Lehmann estimator|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.15|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1500|-2.4400|<0.0001
91484766|NCT03633617|182843528|SUPERIORITY||Hodges-Lehmann estimator|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.27|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.2700|-1.7400|<0.0001
91484767|NCT03633617|182843528|SUPERIORITY||Hodges-Lehmann estimator|-1.255|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.05|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0500|-1.7300|<0.0001
91484768|NCT03633617|182843528|SUPERIORITY||Hodges-Lehmann estimator|-1.275|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.07|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0700|-1.8200|<0.0001
91484769|NCT03633617|182843529|SUPERIORITY||Difference in proportion|21.9||||0.0017|TWO_SIDED|95.0|9.42|34.38|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||34.38|9.42|0.0017
91484770|NCT03633617|182843529|SUPERIORITY||Difference in proportion|27.6|||<|0.0001|TWO_SIDED|95.0|17.2|38.09|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||38.09|17.20|<0.0001
91484771|NCT03633617|182843529|SUPERIORITY||Difference in proportion|28.9|||<|0.0001|TWO_SIDED|95.0|18.36|39.46|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||39.46|18.36|<0.0001
91484772|NCT03633617|182843530|SUPERIORITY||LS Mean Difference|-0.368||||0.0077|TWO_SIDED|95.0|-0.6388|-0.0975|||ANCOVA||Dupilumab group vs Placebo|||-0.0975|-0.6388|0.0077
91484773|NCT03633617|182843530|SUPERIORITY||LS Mean Difference|-0.015||||0.8586|TWO_SIDED|95.0|-0.1782|0.1485|||ANCOVA||Dupilumab group vs. Placebo|||0.1485|-0.1782|0.8586
91484774|NCT03633617|182843530|SUPERIORITY||LS Mean Difference|-0.309||||0.0002|TWO_SIDED|95.0|-0.4703|-0.1471|||ANCOVA||Dupilumab group vs. Placebo|||-0.1471|-0.4703|0.0002
91484775|NCT03633617|182843531|SUPERIORITY||LS Mean Difference|-2.0||||0.0467|TWO_SIDED|95.0|-3.87|-0.03|||ANCOVA||Dupilumab group vs. Placebo|||-0.03|-3.87|0.0467
91484776|NCT03633617|182843531|SUPERIORITY||LS Mean Difference|-0.5||||0.5469||95.0|-2.03|1.08|||ANCOVA||Dupilumab group vs. Placebo|||1.08|-2.03|0.5469
91484777|NCT03633617|182843531|SUPERIORITY||LS Mean Difference|-1.5||||0.0718|TWO_SIDED|95.0|-3.0|0.13|||ANCOVA||Dupilumab group vs. Placebo|||0.13|-3.0|0.0718
91484778|NCT03633617|182843532|SUPERIORITY||LS Mean Difference|-1.7||||0.0051|TWO_SIDED|95.0|-2.93|-0.52|||ANCOVA||Dupilumab group vs. Placebo|||-0.52|-2.93|0.0051
91484779|NCT03633617|182843532|SUPERIORITY||LS Mean Difference|-0.5||||0.3152|TWO_SIDED|95.0|-1.38|0.44|||ANCOVA||Dupilumab group vs. Placebo|||0.44|-1.38|0.3152
91484780|NCT03633617|182843532|SUPERIORITY||LS Mean Difference|-1.4||||0.0037|TWO_SIDED|95.0|-2.3|0.45|||ANCOVA||Dupilumab group vs. Placebo|||0.45|-2.30|0.0037
91484781|NCT03633617|182843533|SUPERIORITY||Difference in proportion|-12.7||||0.017|TWO_SIDED|95.0|-23.21|-2.26|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||-2.26|-23.21|0.0170
91484782|NCT03633617|182843533|SUPERIORITY||Difference in proportion|-1.3||||0.5493|TWO_SIDED|95.0|-5.51|2.93|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||2.93|-5.51|0.5493
91484783|NCT03633617|182843533|SUPERIORITY||Difference in proportion|0.0||||0.9887|TWO_SIDED|95.0|-4.9|5.02|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||5.02|-4.9|0.9887
91525862|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-1.07|-0.74|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.07|<0.0001
91525863|NCT03502616|182927246|SUPERIORITY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-1.25|-0.87|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.87|-1.25|<0.0001
91525864|NCT03502616|182927246|SUPERIORITY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.28|-0.9|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.90|-1.28|<0.0001
91525865|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.16|-0.79|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.79|-1.16|<0.0001
91525866|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.103||0.0623|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||Week 24: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.40|0.0623
91525867|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.106||0.0836|TWO_SIDED|95.0|-0.39|0.02|||Mixed Models Analysis|||Week 32: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.39|0.0836
91525868|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0205|TWO_SIDED|95.0|-0.47|-0.04|||Mixed Models Analysis|||Week 40: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-0.47|0.0205
91525869|NCT03502616|182927246|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.108||0.0614|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|||Week 48: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.42|0.0614
91525870|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.15|-0.7|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.15|<0.0001
91635075|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.227|||<|0.0001|TWO_SIDED|95.0|1.151|1.308|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.308|1.151|<0.0001
91635076|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.814||||0.0289|TWO_SIDED|95.0|0.676|0.979|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, 1st 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.979|0.676|0.0289
91668266|NCT00830167|183230542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0075|TWO_SIDED|95.0|-0.89|-0.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.10|-0.89|0.0075
91668267|NCT00830167|183230543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.21||0.0023|TWO_SIDED|95.0|-1.01|-0.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.18|-1.01|0.0023
91484784|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.28|-0.57|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.28|<0.001
91484785|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
91484786|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.94|-0.23|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.94|0.001
91484787|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.015|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.015
91668268|NCT00830167|183230544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.2568|TWO_SIDED|95.0|-0.57|0.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.29|-0.57|0.2568
91668269|NCT00830167|183230545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.1011|TWO_SIDED|95.0|-0.72|0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.15|-0.72|0.1011
91668270|NCT00830167|183230546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.4165|TWO_SIDED|95.0|-0.44|0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.35|-0.44|0.4165
91668271|NCT00830167|183230547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|1.32||0.0006|TWO_SIDED|95.0|1.7|6.88||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||6.88|1.70|0.0006
91714509|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.97||0.8439||95.0|-8.8|10.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-8.8|0.8439
91714510|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.3||0.9925||95.0|-10.5|10.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.4|-10.5|0.9925
91484788|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.453|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.453
91668272|NCT00830167|183230548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|1.84||0.1805|TWO_SIDED|95.0|-1.93|5.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.29|-1.93|0.1805
91668273|NCT00830167|183230549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|1.5||0.077|TWO_SIDED|95.0|-0.81|5.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.10|-0.81|0.0770
91714511|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|5.02||0.8784||95.0|-9.1|10.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-9.1|0.8784
91714512|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|5.17||0.8948||95.0|-9.5|10.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-9.5|0.8948
91714513|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|5.26||0.2197||95.0|-3.9|16.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.8|-3.9|0.2197
91484789|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.177|TWO_SIDED|95.0|-0.61|0.11|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.61|0.177
91484790|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.7|0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.70|0.062
91484791|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.212|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.59|0.212
91484792|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.34|-0.54|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.54|-1.34|<0.001
91668274|NCT00830167|183230550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|1.2||0.0648|TWO_SIDED|95.0|-0.54|4.19||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||4.19|-0.54|0.0648
91668275|NCT00830167|183230551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.94||0.2068|TWO_SIDED|95.0|-2.23|5.41||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.41|-2.23|0.2068
91668276|NCT00830167|183230552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.92||0.548|TWO_SIDED|95.0|-4.0|3.54||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||3.54|-4.00|0.5480
91668277|NCT00830167|183230553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|1.72||0.0052|TWO_SIDED|95.0|1.04|7.8||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||7.80|1.04|0.0052
91668278|NCT00830167|183230554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|1.39||0.0287|TWO_SIDED|95.0|-0.08|5.37||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.37|-0.08|0.0287
91668279|NCT00830167|183230555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.25||0.0262|TWO_SIDED|95.0|-0.97|0.01||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.01|-0.97|0.0262
91668280|NCT00830167|183230556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.83|0.27||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.27|-0.83|0.1561
91668281|NCT00830167|183230557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.04||0.0013|TWO_SIDED|95.0|-10.2|-2.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-2.18|-10.20|0.0013
91668282|NCT00360490|183230579|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
91714514|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.07||0.6183||95.0|-7.4|12.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-7.4|0.6183
91484793|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.35|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.35|-1.15|<0.001
91484794|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-0.98|-0.18|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.98|0.004
91484795|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.95|0.007
91484796|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.879|TWO_SIDED|95.0|-0.43|0.37|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.37|-0.43|0.879
91484797|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.60|0.330
91484798|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.083|TWO_SIDED|95.0|-0.75|0.05|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.75|0.083
91525871|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.16|-0.68|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.68|-1.16|<0.0001
91668283|NCT00360490|183230580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|62.59|||<|0.001||95.0|50.56|74.61|||Chi-squared|||The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.||74.61|50.56|<0.001
91668284|NCT00360490|183230581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.2|||<|0.001||95.0|-70.2|-28.3|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||-28.3|-70.2|<0.001
91668285|NCT00360490|183230582|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
91668286|NCT00360490|183230583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001||95.0|-63.8|-37.4|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||-37.4|-63.8|<0.001
91668287|NCT00360490|183230593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.06||||||95.0|14.75|37.36||||||A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6||37.36|14.75|
91668288|NCT00950300|183230621|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.|Geometric mean ratio|1.33|||||TWO_SIDED|90.0|1.24|1.44|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.||1.44|1.24|
91668289|NCT00950300|183230622|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.|Difference in response rates|4.7|||||ONE_SIDED|97.5|-4.0||||||The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.|Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.|||-4.0|
91668290|NCT00950300|183230623|OTHER||Geometric mean ratio|1.51|||||TWO_SIDED|90.0|1.4|1.63|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.63|1.40|
91668291|NCT00950300|183230624|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.46|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.46|
91668292|NCT00950300|183230625|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.45|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.45|
91484799|NCT00809354|182843566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.36|TWO_SIDED|95.0|-0.59|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.59|0.360
91714515|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|5.42||0.4484||95.0|-14.8|6.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.5|-14.8|0.4484
91484800|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.23|-0.53|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.23|<0.001
91484801|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.13|<0.001
91668293|NCT00950300|183230634|OTHER||Difference in response rates|5.01|||||TWO_SIDED|95.0|-3.5|13.5|||||The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.|||13.5|-3.5|
91668294|NCT00950300|183230635|OTHER||Difference in response rates|-1.64|||||TWO_SIDED|95.0|-7.4|4.2|||||The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.|||4.2|-7.4|
91668295|NCT00950300|183230635|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.5|1.46|||||OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.46|0.50|
91484802|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.87|0.003
91484803|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.83|-0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.83|0.007
91484804|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.824|TWO_SIDED|95.0|-0.39|0.31|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.39|0.824
91484805|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.18||0.1|TWO_SIDED|95.0|-0.64|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.64|0.100
91668296|NCT00950300|183230638|OTHER||Hazard Ratio (HR)|0.98||||0.8651|TWO_SIDED|95.0|0.74|1.29|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.29|0.74|0.8651
91668297|NCT00950300|183230640|OTHER||Hazard Ratio (HR)|0.94||||0.7767|TWO_SIDED|95.0|0.61|1.45|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.45|0.61|0.7767
91668298|NCT00834613|183230650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.45||||||90.0|99.87|107.15|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.15|99.87|
91668299|NCT00834613|183230651|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.21|100.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.11|95.21|
91714516|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|5.07||0.3857||95.0|-5.6|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-5.6|0.3857
91668300|NCT00834613|183230652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.22|100.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.1|95.22|
91668301|NCT00840840|183230672|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.45||||||90.0|97.71|105.33|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.33|97.71|
91668302|NCT00840840|183230673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|103.05||||||90.0|101.25|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|101.25|
91484806|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.044|TWO_SIDED|95.0|-0.7|-0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.70|0.044
91484807|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.565|TWO_SIDED|95.0|-0.45|0.25|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.45|0.565
91484808|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.62|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.40|<0.001
91525872|NCT03502616|182927247|SUPERIORITY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.4|-0.63|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.63|-1.40|<0.0001
91668303|NCT00840840|183230674|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.94||||||90.0|101.08|104.83|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.83|101.08|
91668304|NCT00840840|183230675|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|99.68||||||90.0|92.41|107.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.52|92.41|
91668305|NCT00840840|183230676|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.48||||||90.0|94.73|108.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.71|94.73|
91668306|NCT00840840|183230677|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|100.17||||||90.0|91.95|109.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.13|91.95|
91484809|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
91484810|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
91484811|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
91484812|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.98|TWO_SIDED|95.0|-0.39|0.4|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.40|-0.39|0.980
91668307|NCT05186415|183230737|OTHER||Intraclass coefficient|0.84|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|Measurements of right ventricular end-diastolic volumes were compared between two groups using an intraclass coefficient||||
91668308|NCT05186415|183230737|OTHER||Intraclass coefficient|0.77|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|Measurements of right ventricular end-diastolic volumes were compared between two groups using an intraclass coefficient||||
91668309|NCT05186415|183230737|OTHER||Intraclass coefficient|0.71|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|Measurements of right ventricular end-systolic volumes were compared between two groups using an intraclass coefficient||||
91668310|NCT05186415|183230737|OTHER||Intraclass coefficient|0.685|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|Measurements of right ventricular end-systolic volumes were compared between two groups using an intraclass coefficient||||
91668311|NCT05186415|183230738|OTHER||Intraclass Coefficient|0.44|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|Measurements of right ventricular ejection fraction were compared between non-contrast echocardiogram and cardiac MRI using an intraclass coefficient||||
91668312|NCT05186415|183230738|OTHER||Intraclass coefficient|0.13|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|Measurements of right ventricular ejection fraction were compared between contrast echocardiogram and cardiac MRI using an intraclass coefficient||||
91668313|NCT05186415|183230740|OTHER|Intraclass coefficient used to assess agreement between non-contrast echocardiographic values and cardiac MRI global longitudinal strain|Intraclass coefficient|0.419|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|||||
91668314|NCT05186415|183230740|OTHER|Intraclass coefficient used to assess agreement between contrast echocardiographic values and cardiac MRI global longitudinal strain|Intraclass coefficient|0.0|||||TWO_SIDED||||||||Intraclass coefficient using a two-way mixed effects model|||||
91668315|NCT03403439|183230741|OTHER||Geometric Mean (T/R) ratio (%)|222.13|||||TWO_SIDED|90.0|203.47|242.49|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variance (%) = 14.2.|The analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. No hypothesis was tested and no acceptance range was specified.||242.49|203.47|
91668316|NCT03403439|183230742|OTHER||Geometric Mean (T/R) ratio (%)|127.96|||||TWO_SIDED|90.0|117.65|139.17|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variance (%) = 13.6.|The analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. No hypothesis was tested and no acceptance range was specified.||139.17|117.65|
91668317|NCT03403439|183230743|OTHER||Geometric Mean (T/R) ratio (%)|229.26|||||TWO_SIDED|90.0|207.82|252.93|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variance (%) = 15.9.|The analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. No hypothesis was tested and no acceptance range was specified.||252.93|207.82|
91668318|NCT00288704|183230748|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
91668319|NCT00288704|183230749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||"Subjects received rilonacept 160 mg for 9 weeks (weeks 6-15), and then were re-randomized 1:1 into either Placebo or rilonacept 160 mg. The endpoint for the period was 9 weeks later (week 24).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.001
91668320|NCT00288704|183230750|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
91792580|NCT02129777|183462757|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|4.89||0.697|TWO_SIDED|95.0|-11.7|7.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.8|-11.7|0.697
91484813|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.383|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.56|0.383
91484814|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.057|TWO_SIDED|95.0|-0.77|0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.77|0.057
91668321|NCT00288704|183230751|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison P-Value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
91484815|NCT00809354|182843567|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.312|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.59|0.312
91484816|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.008
91484817|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
91484818|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
91668322|NCT00288704|183230752|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value is a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
91668323|NCT00288704|183230753|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.0001
91668324|NCT00288704|183230754|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.01
91668325|NCT00288704|183230755|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
91484819|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.961|TWO_SIDED|95.0|-0.14|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.14|0.961
91635077|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276|||<|0.0001|TWO_SIDED|95.0|1.177|1.383|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.383|1.177|<0.0001
91635078|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.0099|TWO_SIDED|95.0|0.821|0.973|||Regression, Logistic|||The statistical analysis is presented for Cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.973|0.821|0.0099
91635079|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
91635080|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
91668326|NCT00288704|183230756|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
91668327|NCT00288704|183230757|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
91668328|NCT00676650|183230761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.1678|TWO_SIDED|95.0|0.762|1.097||1-sided p-value from the stratified log-rank test|Log Rank||Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.|||1.097|0.762|0.1678
91668329|NCT00676650|183230762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725|||<|0.001|TWO_SIDED|95.0|0.591|0.89||1-sided p-value from the stratified log-rank test.|Log Rank||Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.|||0.890|0.591|<0.001
91668330|NCT00676650|183230763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.561||||0.04|TWO_SIDED|95.0|1.0|19.0||p-value from 2-sided Fisher's Exact test.|Fisher Exact|||||19.0|1.0|0.040
91484820|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.272|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.272
91484821|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.271|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.271
91635081|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
91635082|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
91668331|NCT05061992|183230770|SUPERIORITY|||||||0.6|||||||ANCOVA|||Change in SF-8||||0.6
91668332|NCT05061992|183230770|SUPERIORITY|||||||0.2|||||||ANCOVA|||End of trial SF-8||||0.2
91668333|NCT05061992|183230771|SUPERIORITY|||||||0.001|||||||ANCOVA|||Change in ANT||||0.001
91668334|NCT05061992|183230771|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||End of trial ANT||||0.09
91668335|NCT05061992|183230772|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91668336|NCT05061992|183230773|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
91668337|NCT05061992|183230774|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
91668338|NCT05061992|183230775|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
91668339|NCT02153723|183230784|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|21.6||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
91668340|NCT02153723|183230785|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-2.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
91668341|NCT02153723|183230786|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-0.1||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
91668342|NCT02153723|183230787|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|15.9||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
91668343|NCT02153723|183230788|OTHER|Wilcoxon signed rank sum test|Mean Difference (Final Values)|0.8||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
91668344|NCT02153723|183230789|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
91484822|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.128
91484823|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.133|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.133
91484824|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.002
91484825|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.34|-0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.34|0.004
91484826|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.414|TWO_SIDED|95.0|-0.2|0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.20|0.414
91484827|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.057|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.057
91484828|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED|95.0|-0.06|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.06|0.277
91484829|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.328|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.328
91484830|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.30|0.026
91484831|NCT00809354|182843568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.864|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.864
91527839|NCT06173570|182930689|SUPERIORITY||Mean Difference (Net)|1.26||||0.509|TWO_SIDED|95.0|-2.48|5.0|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||5.00|-2.48|0.509
91635083|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.615||||0.0205|TWO_SIDED|95.0|1.219|10.721|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||10.721|1.219|0.0205
91668345|NCT01157234|183230801|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|28.73|||||TWO_SIDED|95.0|1.93|55.53||||||||55.53|1.93|
91668346|NCT01157234|183230802|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.27|||||TWO_SIDED|95.0|-12.58|29.12||||||||29.12|-12.58|
91668347|NCT01157234|183230803|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.23|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-6.74|9.2||||||||9.20|-6.74|
91484832|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
91484833|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
91484834|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
91484835|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
91484836|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
91668348|NCT01157234|183230807|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.94|||||TWO_SIDED|95.0|0.48|23.4||||||||23.40|0.48|
91668349|NCT01157234|183230808|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|69.54|STANDARD_ERROR_OF_MEAN|19.83|||TWO_SIDED|99.7|12.71|126.37||||||||126.37|12.71|
91668350|NCT01157234|183230809|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|68.19|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|99.17|13.02|123.36||||||||123.36|13.02|
91668351|NCT01157234|183230810|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.39|STANDARD_ERROR_OF_MEAN|17.32|||TWO_SIDED|99.17|-48.25|51.03||||||||51.03|-48.25|
91668352|NCT01157234|183230811|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|17.96|||TWO_SIDED|99.17|-48.74|54.22||||||||54.22|-48.74|
91668353|NCT00059332|183230848|SUPERIORITY_OR_OTHER|||||||0.28|ONE_SIDED||||||Cochran-Mantel-Haenszel|||For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.||||0.28
91668354|NCT00059332|183230849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||||1.20|0.81|0.87
91668355|NCT00059332|183230850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.19|||Chi-squared|||||1.19|0.81|0.87
91668356|NCT00059332|183230851|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2760
91668357|NCT00059332|183230852|SUPERIORITY_OR_OTHER|||||||0.3912|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3912
91792581|NCT02129777|183462757|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.1||0.633|TWO_SIDED|95.0|-12.6|7.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.7|-12.6|0.633
91484837|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
91484838|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
91484839|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
91484840|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
91484841|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
91484842|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
91668358|NCT00059332|183230853|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3230
91668359|NCT00059332|183230854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.95|TWO_SIDED|95.0|0.87|1.27|||Chi-squared|||||1.27|0.87|0.95
91668360|NCT00059332|183230855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.12|TWO_SIDED|95.0|0.34|1.14|||Chi-squared|||||1.14|0.34|0.12
91668361|NCT00059332|183230856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.76|1.29|||Chi-squared|||||1.29|0.76|0.95
91668362|NCT00487695|183230862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|95.0|||||Wilcoxon signed rank|||Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.||||0.01
91668363|NCT00487695|183230863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.||||0.89
91668364|NCT00487695|183230864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||wilcoxon signed rank test|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||0.002
91668365|NCT00487695|183230866|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).||||1.0
91668366|NCT00487695|183230867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed-rank|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||<0.0001
91668367|NCT01358877|183230869|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.043|TWO_SIDED|95.0|0.68|0.99||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.68|0.0430
91668368|NCT01358877|183230872|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0327|TWO_SIDED|95.0|0.67|0.98||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.98|0.67|0.0327
91668369|NCT01358877|183230875|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4673|TWO_SIDED|95.0|0.66|1.21||The O'Brien-Fleming stopping boundary of the Lan-DeMets alpha-spending function for the first interim OS analysis was HR\<0.52; p\<0.00001.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.21|0.66|0.4673
91668370|NCT01358877|183230876|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0441|TWO_SIDED|95.0|0.69|1.0||The p-value threshold according to the alpha-spending function at this final analysis was 0.0496.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.00|0.69|0.0441
91668371|NCT01358877|183230879|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.63|0.99|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.63|0.0430
91668372|NCT01358877|183230882|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.64|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.04|0.64|0.1007
91668373|NCT01358877|183230885|SUPERIORITY||Treatment Difference|0.4|||||TWO_SIDED|95.0|0.0|0.8|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.|||0.8|0.0|
91668374|NCT01358877|183230886|SUPERIORITY||Treatment Difference|0.4|||||TWO_SIDED|95.0|-0.1|0.9|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.|||0.9|-0.1|
91668375|NCT01358877|183230887|SUPERIORITY||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.9|||||95% CI was estimated using Hauck-Anderson correction.|||0.9|-1.0|
91668376|NCT01358877|183230888|SUPERIORITY||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-1.1|0.9|||||95% CI was estimated using Hauck-Anderson correction.|||0.9|-1.1|
91668377|NCT01358877|183230889|SUPERIORITY||Treatment Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||95% CI was estimated using Hauck-Anderson correction.|||0.5|-0.3|
91668378|NCT01358877|183230890|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||95% CI was estimated using Hauck-Anderson correction.|||0.4|-0.4|
91668379|NCT01358877|183230906|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0446|TWO_SIDED|95.0|0.66|1.0||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.00|0.66|0.0446
91714517|NCT00676403|183320249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8824||95.0|-11.0|9.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-11.0|0.8824
91792582|NCT02129777|183462758|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.64||0.537|TWO_SIDED|95.0|-2.2|4.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.3|-2.2|0.537
91484843|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
91484844|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
91484845|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
91484846|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
91668380|NCT01742208|183230930|SUPERIORITY||LS Mean Difference|-25.14||||0.007|TWO_SIDED|95.0|-42.78|-7.49||Threshold for significance at 0.05 level.|ANCOVA||Difference is sotagliflozin - placebo|Between-group comparison of the 2 Expansion Groups was based on an ANCOVA model with covariates of baseline mean total daily bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group.||-7.49|-42.78|0.007
91668381|NCT00766493|183230938|SUPERIORITY_OR_OTHER||Proportion|0.043|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.021|0.077||Reject H0 if z\<-1.96, or 1-sided p\<0.025.|One Sample Binomial|Significance test was based on a one-sample normal approximation to the binomial test.|The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.|"This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025."||0.077|0.021|0.0001
91668382|NCT02707276|183230943|SUPERIORITY||Mean Difference (Final Values)|-0.625|STANDARD_DEVIATION|12.0|<|0.76|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|mean raw change active-sham; pooled standard deviation|Repeated measures ANCOVA with baseline MADRS scores as covariate for treatment and order effects of difference in MADRS scores.||||<0.76
91668383|NCT02707276|183230943|SUPERIORITY||Mean Difference (Final Values)|-5.17|STANDARD_DEVIATION|4.96|<|0.33|TWO_SIDED||||||ANCOVA|Baseline covariate|Pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.33
91668384|NCT02707276|183230944|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|9.1|<|0.61|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw change active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline HARS scores as covariate for treatment and order effects of difference in HARS scores.||||<0.61
91668385|NCT02707276|183230944|SUPERIORITY||Mean Difference (Final Values)|-4.33|STANDARD_DEVIATION|4.0|<|0.32|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.32
91668386|NCT02707276|183230945|SUPERIORITY||Mean Difference (Final Values)|-1.625|STANDARD_DEVIATION|10.2|<|0.78|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline PANAS (Positive sub scale) scores as covariate for treatment and order effects of difference in PANAS (Positive sub scale) scores.||||<0.78
91668387|NCT02707276|183230945|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.42|<|0.99|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.99
91668388|NCT02786927|183230961|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91668389|NCT02786927|183230962|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91668390|NCT02786927|183230963|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91668391|NCT01801917|183230964|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.586||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 2mg group vs. placebo||||
91668392|NCT01801917|183230964|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.022||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 2mg group vs. placebo||||
91668393|NCT01801917|183230964|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.963||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 10mg group vs. placebo||||
91792583|NCT02129777|183462758|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|1.62||0.142|TWO_SIDED|95.0|-0.8|5.6|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.6|-0.8|0.142
91668394|NCT01801917|183230964|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.837||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 10mg group vs. placebo||||
91668395|NCT03919695|183230975|SUPERIORITY||Odds Ratio (OR)|0.29||||0.002|TWO_SIDED|95.0|0.11|0.73|||GEE model specifying a logistic distribu||time x arm effect for the comparison at 6-month follow-up|Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interaction||.73|.11|.002
91668396|NCT02416934|183230987|SUPERIORITY||Mean Difference (Final Values)|-1.5392|STANDARD_ERROR_OF_MEAN|0.7176||0.036|TWO_SIDED|95.0|-2.9761|-0.1022|||t-test, 2 sided|||Comparing DSQ between Dexamethasone and Saline at Day 1 post-op||-.1022|-2.9761|0.036
91668397|NCT02416934|183230987|SUPERIORITY||Mean Difference (Final Values)|-0.604|STANDARD_ERROR_OF_MEAN|0.2543|<|0.05|TWO_SIDED|95.0|-1.1151|-0.093|||t-test, 2 sided|||Comparing Bazaz between Dexamethasone and Saline at 6 months post-op||-.0930|-1.1151|<.05
91668398|NCT02416934|183230988|SUPERIORITY||Mean Difference (Final Values)|1.7874|STANDARD_ERROR_OF_MEAN|3.1273|<|0.05|TWO_SIDED|95.0|-4.5153|8.0902|||t-test, 2 sided|||Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit||8.0902|-4.5153|<.05
91668399|NCT02416934|183230989|SUPERIORITY|||||||0.375||||||Fisher's Exact Test|Fisher Exact|||||||.375
91668400|NCT00494013|183230990|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.4%.|Mean Difference (Net)|-0.21||||0.026||95.0|-0.39|-0.03|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).||-0.03|-0.39|0.026
91668401|NCT00494013|183230991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
91668402|NCT00494013|183230991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
91668403|NCT00494013|183230991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
91668404|NCT00494013|183230991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
91484847|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
91484848|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.50|-1.17|<0.001
91484849|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.22|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.22|<0.001
91484850|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.01|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.01|<0.001
91484851|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.85|0.003
91484852|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.341|TWO_SIDED|95.0|-0.5|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.50|0.341
91484853|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.031|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.71|0.031
91484854|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.349|TWO_SIDED|95.0|-0.49|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.49|0.349
91792584|NCT02129777|183462758|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.63||0.015|TWO_SIDED|95.0|0.8|7.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.3|0.8|0.015
91484855|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.29|0.780
91484856|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.31|<0.001
91484857|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.29|<0.001
91484858|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.99|<0.001
91484859|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.88|0.005
91668405|NCT00494013|183230992|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.463
91792585|NCT02129777|183462758|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.64||0.121|TWO_SIDED|95.0|-0.7|5.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.8|-0.7|0.121
91792586|NCT02915874|183462759|SUPERIORITY||Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.02
91484860|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.26|-0.47|0.562
91484861|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.028|TWO_SIDED|95.0|-0.77|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.77|0.028
91484862|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.19||0.084|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.68|0.084
91484863|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.91|TWO_SIDED|95.0|-0.38|0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.38|0.910
91484864|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.69|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.40|<0.001
91484865|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.27|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.27|<0.001
91668406|NCT00494013|183230992|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.135
91792587|NCT02915874|183462760|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.78||0.19|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.19
91792588|NCT02915874|183462761|SUPERIORITY||Slope|2.07|STANDARD_ERROR_OF_MEAN|1.86||0.27|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.27
91484866|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.25|-0.55|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.25|<0.001
91635084|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.981||||0.9557|TWO_SIDED|95.0|0.506|1.903|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.903|0.506|0.9557
91635085|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.599||||0.2|TWO_SIDED|95.0|0.273|1.312|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.312|0.273|0.2000
91635086|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.684||||0.0437|TWO_SIDED|95.0|1.037|13.083|||Regression, Logistic|||The statistical analysis is presented for (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||13.083|1.037|0.0437
91635087|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|134.6|||<|0.0001|TWO_SIDED|95.0|17.956|1009.0|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1009.0|17.956|<0.0001
91668407|NCT00494013|183230993|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per Liter (mmol/L).|Mean Difference (Net)|0.1||||0.107||95.0|-0.02|0.23|||ANOVA|ANOVA model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The first gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to determir.||0.23|-0.02|0.107
91668408|NCT00494013|183230994|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||P-value for Average 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.952
91668409|NCT00494013|183230994|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||P-value for Average Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.856
91668410|NCT00494013|183230994|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Average Post-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.790
91668411|NCT00494013|183230994|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for Average Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.632
91668412|NCT00494013|183230995|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for All Hypoglycemic Events.|Fisher Exact|||||||0.472
91668413|NCT00494013|183230995|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Nocturnal Hypoglycemic Events.|Fisher Exact|||||||0.005
91792589|NCT02915874|183462762|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|21.3||0.98|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.98
91792590|NCT02915874|183462763|SUPERIORITY||Slope|1.03|STANDARD_ERROR_OF_MEAN|2.58||0.69|TWO_SIDED|||||a priori: 0.05|Mixed Models Analysis|||||||0.69
91792591|NCT02915874|183462764|SUPERIORITY||Slope|-2.77|STANDARD_ERROR_OF_MEAN|4.93||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
91792592|NCT02915874|183462765|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.58||0.08|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.08
91792593|NCT04973137|183462791|SUPERIORITY||Hazard Ratio (HR)|0.915||||0.768|TWO_SIDED|95.0|0.508|1.649|||Log Rank|||||1.649|.508|0.7680
91484867|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.88|-0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.88|0.003
91484868|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.039|TWO_SIDED|95.0|-0.72|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.72|0.039
91668414|NCT00494013|183230995|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value for Severe Hypoglycemic Events.|Fisher Exact|||||||0.450
91668415|NCT00494013|183230996|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
91668416|NCT00494013|183230996|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
91668417|NCT00494013|183230996|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.226
91668418|NCT00494013|183230998|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|1.5|||<|0.001||95.0|0.93|2.06||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The second gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to detemir with regard to change in absolute body weight from baseline to endpoint (last observation carried forward).||2.06|0.93|<0.001
91668419|NCT00494013|183230999|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.074
91525873|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.19|-0.74|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.19|<0.0001
91635088|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.905|||<|0.0001|TWO_SIDED|95.0|10.521|576.85|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||576.85|10.521|<0.0001
91635089|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.527||||0.0105|TWO_SIDED|95.0|1.872|112.73|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||112.73|1.872|0.0105
91635090|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0041|TWO_SIDED|95.0|1.152|2.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.120|1.152|0.0041
91668420|NCT00494013|183231000|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.039
91668421|NCT00494013|183231001|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Fisher Exact|||||||0.026
91635091|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.557|||<|0.0001|TWO_SIDED|95.0|2.405|12.838|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.838|2.405|<0.0001
91668422|NCT02614196|183231010|SUPERIORITY||LSMean Difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.55|-1.48|||Mixed Models Analysis|||||-1.48|-2.55|<.001
91668423|NCT02614196|183231010|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.44|-1.36|||Mixed Models Analysis|||||-1.36|-2.44|<.001
91668424|NCT02614196|183231011|SUPERIORITY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|2.03|3.32||||||Reduction from Baseline ≥50%||3.32|2.03|
91668425|NCT02614196|183231011|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|1.81|2.96||||||Reduction from Baseline ≥50%||2.96|1.81|
91668426|NCT02614196|183231011|SUPERIORITY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.78|3.06||||||Reduction from Baseline ≥75%||3.06|1.78|
91668427|NCT02614196|183231011|SUPERIORITY||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.84|3.17||||||Reduction from Baseline ≥75%||3.17|1.84|
91668428|NCT02614196|183231011|SUPERIORITY||Odds Ratio (OR)|2.16|||||TWO_SIDED|95.0|1.5|3.12||||||Reduction from Baseline ≥100%||3.12|1.50|
91668429|NCT02614196|183231011|SUPERIORITY||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.87|3.81||||||Reduction from Baseline ≥100%||3.81|1.87|
91668430|NCT02614196|183231012|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|6.33|11.31|||Mixed Models Analysis|||||11.31|6.33|<.001
91668431|NCT02614196|183231012|SUPERIORITY||LSMean Difference|7.39|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|4.88|9.9|||Mixed Models Analysis|||||9.90|4.88|<.001
91668432|NCT02614196|183231013|SUPERIORITY||LSMean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.29|-1.36|||Mixed Models Analysis|||||-1.36|-2.29|<.001
91668433|NCT02614196|183231013|SUPERIORITY||LSMean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.001
91668434|NCT02614196|183231014|SUPERIORITY||LSMean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.002|TWO_SIDED|95.0|-0.47|-0.11|||Mixed Models Analysis|||||-0.11|-0.47|.002
91668435|NCT02614196|183231014|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.012|TWO_SIDED|95.0|-0.41|-0.05|||Mixed Models Analysis|||||-0.05|-0.41|.012
91668436|NCT02614196|183231015|SUPERIORITY||LSMean Difference|-15.19|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-20.27|-10.11|||Mixed Models Analysis|||||-10.11|-20.27|<.001
91668437|NCT02614196|183231015|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.67|-8.44|||Mixed Models Analysis|||||-8.44|-18.67|<.001
91668438|NCT02614196|183231016|SUPERIORITY||LSMean Difference|-9.15|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-12.61|-5.69|||Mixed Models Analysis|||||-5.69|-12.61|<.001
91668439|NCT02614196|183231016|SUPERIORITY||LSMean Difference|-8.22|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-11.71|-4.72|||Mixed Models Analysis|||||-4.72|-11.71|<.001
91668440|NCT02614196|183231017|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive.||||<.001
91668441|NCT02614196|183231017|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive||||<.001
91668442|NCT00633022|183231035|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4519|TWO_SIDED|95.0|-0.14|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.ANCOVA model, fitting fixed effect treatment term,|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg BID versus Placebo||0.06|-0.14|0.4519
91668443|NCT00633022|183231035|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.5789|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.06|-0.11|0.5789
91668444|NCT00633022|183231036|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.6986|TWO_SIDED|95.0|-0.15|0.1|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg twice daily versus placebo||0.10|-0.15|0.6986
91792594|NCT04973137|183462792|SUPERIORITY||Hodge-Lehmann Median Difference (Net)|-8.5||||0.5288|TWO_SIDED|95.0|-35.47|18.46|||Rank ANCOVA|||||18.46|-35.47|0.5288
91792595|NCT04973137|183462793|SUPERIORITY||Hodge-Lehmann Median Difference (Net)|0.34||||0.9597|TWO_SIDED|95.0|-2.68|3.37|||Rank ANCOVA|||||3.37|-2.68|0.9597
91484869|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.032|TWO_SIDED|95.0|-0.74|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.74|0.032
91484870|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.409|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.50|0.409
91525874|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.2|-0.72|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.72|-1.20|<0.0001
91635092|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.822||||0.0037|TWO_SIDED|95.0|1.216|2.732|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.732|1.216|0.0037
91635093|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.342|||<|0.0001|TWO_SIDED|95.0|3.977|32.347|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||32.347|3.977|<0.0001
91635094|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
91635095|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
91635096|NCT01066819|183163041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.921||||0.0035|TWO_SIDED|95.0|1.686|14.362|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||14.362|1.686|0.0035
91635097|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
91635098|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
91668445|NCT00633022|183231036|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.12|-0.13|0.9486
91668446|NCT01374451|183231081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.991||||0.488|TWO_SIDED|95.0|0.636|1.543|||Log Rank|||||1.543|0.636|0.488
91668447|NCT04640194|183231098|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.39|2.61|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||2.61|0.39|
91668448|NCT04640194|183231098|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.27|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||3.27|0.46|
91484871|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.461|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.461
91484872|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.59|<0.001
91668449|NCT04640194|183231098|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.73|4.15|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||4.15|0.73|
91668450|NCT04640194|183231098|OTHER||Hazard Ratio (HR)|2.04|||||TWO_SIDED|95.0|0.83|5.01|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||5.01|0.83|
91668451|NCT04640194|183231098|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.35|3.66|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||3.66|0.35|
91668452|NCT04640194|183231098|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.33|4.22|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||4.22|0.33|
91668453|NCT04640194|183231099|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-10.892|24.8734|||||Chan and Zhang exact confidence interval.|||24.8734|-10.892|
91668454|NCT04640194|183231099|OTHER||Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|2.3075|43.6615|||||Chan and Zhang exact confidence interval.|||43.6615|2.3075|
91668455|NCT04640194|183231099|OTHER||Risk Difference (RD)|11.76|||||TWO_SIDED|95.0|-24.127|36.9012|||||Chan and Zhang exact confidence interval.|||36.9012|-24.127|
91668456|NCT04640194|183231100|OTHER||Risk Difference (RD)|-16.6|||||TWO_SIDED|95.0|-38.6|5.5|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||5.5|-38.6|
91668457|NCT04640194|183231100|OTHER||Risk Difference (RD)|-11.8|||||TWO_SIDED|95.0|-35.1|11.6|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||11.6|-35.1|
91668458|NCT04640194|183231100|OTHER||Risk Difference (RD)|-19.1||||0.2419|TWO_SIDED|95.0|-51.1|12.9|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Unadjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for treatment.||12.9|-51.1|0.2419
91635099|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for Alanine Aminotransferase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
91635100|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
91635101|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
91792596|NCT04391569|183462827|OTHER|||||||0||||||P-value from logistic regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.0000
91668459|NCT04640194|183231101|OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-37.1|19.1|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.1|-37.1|
91668460|NCT04640194|183231101|OTHER||Risk Difference (RD)|-9.1|||||TWO_SIDED|95.0|-37.2|19.0|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.0|-37.2|
91668461|NCT04640194|183231101|OTHER||Risk Difference (RD)|14.5||||0.2523|TWO_SIDED|95.0|-10.3|39.3|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for baseline D-dimer status, age, days of NIV support and treatment.||39.3|-10.3|0.2523
91668462|NCT04640194|183231102|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-4.4|10.6|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||10.6|-4.4|
91668463|NCT04640194|183231102|OTHER||Median Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-3.2|11.8|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||11.8|-3.2|
91668464|NCT04640194|183231103|OTHER||Risk Difference (RD)|-4.9|||||TWO_SIDED|95.0|-29.0|19.2|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.2|-29.0|
91668465|NCT04640194|183231103|OTHER||Risk Difference (RD)|-15.2|||||TWO_SIDED|95.0|-36.8|6.3|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||6.3|-36.8|
91668466|NCT04640194|183231104|OTHER||Median Difference (Net)|17.193|||||TWO_SIDED|95.0|-28.45|52.33|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||52.33|-28.45|
91668467|NCT04640194|183231104|OTHER||Median Difference (Final Values)|54.436|||||TWO_SIDED|95.0|0.49|110.36|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||110.36|0.49|
91484873|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.4|-0.65|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.40|<0.001
91668468|NCT04640194|183231106|OTHER||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|3.6||0.9856|TWO_SIDED|95.0|-7.5|7.6|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||7.6|-7.5|0.9856
91668469|NCT04640194|183231106|OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|3.8||0.8729|TWO_SIDED|95.0|-8.5|7.3|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level and age.||7.3|-8.5|0.8729
91668470|NCT04640194|183231107|OTHER||Mean Difference (Net)|70.9|STANDARD_ERROR_OF_MEAN|35.8||0.0603|TWO_SIDED|95.0|-3.3|145.1|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||145.1|-3.3|0.0603
91668471|NCT04640194|183231107|OTHER||Mean Difference (Final Values)|87.2|STANDARD_ERROR_OF_MEAN|38.5||0.0362|TWO_SIDED|95.0|6.3|168.0|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level, baseline PaO2/FiO2 ratio and age.||168.0|6.3|0.0362
91792597|NCT04391569|183462828|OTHER|||||||0.1619||||||P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derive by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.1619
91484874|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.17|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.17|<0.001
91527840|NCT06173570|182930690|SUPERIORITY||Mean Difference (Net)|-27.0|||<|0.001|TWO_SIDED|95.0|-33.08|-20.93|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-20.93|-33.08|< 0.001
91635102|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
91635103|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
91635104|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
91635105|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
91635106|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
91635107|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
91668472|NCT03201003|183231131|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.0001|TWO_SIDED|95.0|44.1|65.2|||Fisher Exact|||Treatment difference at 1000 mg||65.2|44.1|<0.0001
91792598|NCT04391569|183462830|OTHER|||||||0.2097|||||||fixed weight combination test|||||||0.2097
91792599|NCT04391569|183462831|OTHER|||||||0|||||||Log Rank|||||||0.0000
91484875|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.97|0.002
91484876|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.281|TWO_SIDED|95.0|-0.58|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.58|0.281
91668473|NCT03201003|183231132|SUPERIORITY||Risk Difference (RD)|58.9|||<|0.0001|TWO_SIDED|95.0|44.2|69.3|||Fisher Exact|||Treatment difference at 600 mg||69.3|44.2|<0.0001
91668474|NCT03201003|183231133|SUPERIORITY||Risk Difference (RD)|57.2|||<|0.0001|TWO_SIDED|95.0|41.2|69.1|||Fisher Exact|||Treatment difference at 300 mg||69.1|41.2|<0.0001
91635108|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
91635109|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.401||||0.0071|TWO_SIDED|95.0|0.206|0.78|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.780|0.206|0.0071
91635110|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.016||||0.0006|TWO_SIDED|95.0|0.001|0.169|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.169|0.001|0.0006
91635111|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.076||||0.0255|TWO_SIDED|95.0|0.008|0.729|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.729|0.008|0.0255
91484877|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.023|TWO_SIDED|95.0|-0.81|-0.06|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.81|0.023
91635112|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.184||||0.1501|TWO_SIDED|95.0|0.018|1.845|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.845|0.018|0.1501
91635113|NCT01066819|183163058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.25|||<|0.0001|TWO_SIDED|95.0|6.729|110.35|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs RVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||110.35|6.729|<0.0001
91635114|NCT03812224|183163062|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001||95.0|-2.52|-0.73|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type and prior migraine preventive treatment status, and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.73|-2.52|<0.001
91635115|NCT03812224|183163063|SUPERIORITY||Odds Ratio (OR)|2.33||||0.005|TWO_SIDED|95.0|1.29|4.23|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factors of migraine type and prior migraine preventive treatment status.||||4.23|1.29|0.005
91635116|NCT03812224|183163064|SUPERIORITY||LS Mean Difference|-1.47|||<|0.001||95.0|-2.24|-0.71|||Generalized Linear Mixed Model|||Analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type (episodic migraine or chronic migraine) and prior migraine preventive treatment status (ever used or never used), and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.71|-2.24|<0.001
91635117|NCT02600715|183163067|EQUIVALENCE|Test for differences in continuous variables.||||||0.94||||||Two-sided alpha of 0.05 was used to determine statistical significance.|Kruskal-Wallis|||||||0.94
91635118|NCT00612573|183163087|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.75|STANDARD_DEVIATION|0.85||0.779|TWO_SIDED|95.0|-14.8|10.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||10.3|-14.8|0.779
91668475|NCT03201003|183231134|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country||Treatment difference in Maximum Severity||||<0.0001
91668476|NCT01994980|183231135|SUPERIORITY||||||<|0.01||||||This is a calculated p value.|Wilcoxon (Mann-Whitney)|||||||<0.01
91668477|NCT00096460|183231157|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|62.7|||||TWO_SIDED|95.0|43.8|89.6||||||||89.6|43.8|
91668478|NCT00096460|183231157|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|85.7||||||95.0|63.3|100.0||||||||100|63.3|
91668479|NCT00697619|183231186|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.370
91668480|NCT00697619|183231186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91668481|NCT00697619|183231186|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91668482|NCT01705717|183231199|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Chi-squared|||||||0.034
91668483|NCT01705717|183231200|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Chi-squared|||||||0.007
91792600|NCT04391569|183462832|OTHER|||||||0.0075||||||P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test. P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|||||||0.0075
91635119|NCT00612573|183163087|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.69|STANDARD_DEVIATION|0.9||0.983|TWO_SIDED|95.0|-13.7|11.7|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||11.7|-13.7|0.983
91635120|NCT00612573|183163087|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.92|STANDARD_DEVIATION|0.97||0.087|TWO_SIDED|95.0|-1.5|27.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||27.3|-1.5|0.087
91635121|NCT00612573|183163088|SUPERIORITY_OR_OTHER|||||||0.807||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.807
91635122|NCT00612573|183163088|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.075
91635123|NCT00612573|183163088|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.039
91635124|NCT00612573|183163089|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.212
91668484|NCT02293460|183231205|SUPERIORITY|The response rate was tested against the historical response rate of 33.3%.|Responder rate|76.2|||<|0.0001|TWO_SIDED|95.0|60.5|87.9||One-sided test at nominal level of significance alpha = 2.5 %|exact binomial Clopper-Pearson|||"For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows:~H0: pI10E \<= 33.3% H1: pI10E \> 33.3%"||87.9|60.5|<0.0001
91668485|NCT00706719|183231206|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.118
91668486|NCT00706719|183231206|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.006
91484878|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.031|TWO_SIDED|95.0|-0.79|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.79|0.031
91668487|NCT00706719|183231206|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.009
91714518|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|7.87||0.1673||95.0|-4.6|26.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.4|-4.6|0.1673
91714519|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|7.71||0.9839||95.0|-15.0|15.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.3|-15.0|0.9839
91714520|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|8.06||0.2905||95.0|-7.3|24.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.4|-7.3|0.2905
91714521|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|7.69||0.5513||95.0|-10.6|19.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.7|-10.6|0.5513
91525875|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.073||0.4731|TWO_SIDED|95.0|-0.2|0.09|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.20|0.4731
91635125|NCT00612573|183163089|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.505
91668488|NCT00706719|183231206|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.0024
91668489|NCT00706719|183231207|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Baseline.||||0.15
91484879|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.331|TWO_SIDED|95.0|-0.56|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.56|0.331
91484880|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.47|<0.001
91668490|NCT00706719|183231207|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 3.||||0.0067
91668491|NCT00706719|183231207|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 6.||||0.10
91668492|NCT00706719|183231207|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.26
91714522|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1589||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1589
91635126|NCT00612573|183163089|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.399
91635127|NCT00612573|183163090|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.276
91635128|NCT00612573|183163090|SUPERIORITY_OR_OTHER|||||||0.231||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.231
91635129|NCT00612573|183163090|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.081
91635130|NCT02516605|183163107|OTHER||adjusted fold change from baseline|0.86||||0.293|TWO_SIDED|90.0|0.68|1.09|||ANCOVA|||||1.09|0.68|0.293
91484881|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.6|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.33|<0.001
91635131|NCT02516605|183163107|OTHER||adjusted fold change from baseline|0.47|||<|0.001|TWO_SIDED|90.0|0.37|0.6|||ANCOVA|||||0.60|0.37|<0.001
91635132|NCT02516605|183163107|OTHER||adjusted fold change from baseline|0.32|||<|0.001|TWO_SIDED|90.0|0.26|0.4|||ANCOVA|||||0.40|0.26|<.001
91635133|NCT02516605|183163107|OTHER||adjusted fold change from baseline|0.36|||<|0.001|TWO_SIDED|90.0|0.27|0.47|||ANCOVA|||||0.47|0.27|<.001
91668493|NCT00706719|183231208|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.880
91714523|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|7.95||0.0541||95.0|-0.3|31.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||31.0|-0.3|0.0541
91714524|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.66||0.5987||95.0|-11.0|19.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.1|-11.0|0.5987
91714525|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|8.1||0.4372||95.0|-9.6|22.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.2|-9.6|0.4372
91792601|NCT04641221|183462837|SUPERIORITY||incidence rate ratio|1.1||||0.028|TWO_SIDED|90.0|1.02|1.18||main effect for one-on-one sessions.|zero-inflated negative-binomial (ZINB)|We specified a multilevel (week nested within participant) model which included terms for each main effect and each interaction effect and covariates.|Main effect for One-one sessions.|There were four potential intervention components. This study used a 2x2x2x2 factorial design. Thus, we analyzed main and interaction effects for the four potential intervention components.||1.18|1.02|0.028
91635134|NCT02516605|183163117|OTHER||Median difference from baseline|1.0||||0.898|TWO_SIDED|90.0|-7.0|6.0|||Wilcoxon rank-sum test|Day 28||||6.0|-7.0|0.898
91668494|NCT00706719|183231208|SUPERIORITY_OR_OTHER|||||||0.612|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.612
91668495|NCT00706719|183231208|SUPERIORITY_OR_OTHER|||||||0.488|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.488
91668496|NCT00706719|183231208|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.054
91668497|NCT00706719|183231209|SUPERIORITY_OR_OTHER|||||||0.705|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.705
91668498|NCT00706719|183231209|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.013
91668499|NCT00706719|183231209|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.004
91668500|NCT00706719|183231209|SUPERIORITY_OR_OTHER|||||||0.808|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.808
91484882|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.03|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.03|<0.001
91668501|NCT00706719|183231210|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.008
91668502|NCT00706719|183231210|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.015
91668503|NCT00706719|183231210|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.003
91714526|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|7.71||0.8336||95.0|-16.8|13.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.6|-16.8|0.8336
91635135|NCT02516605|183163117|OTHER||Median difference from baseline|2.0||||0.593|TWO_SIDED|90.0|-4.0|10.0|||Wilcoxon rank-sum test|Day 56||||10.0|-4.0|0.593
91635136|NCT02516605|183163117|OTHER||Median difference from baseline|-3.0||||0.509|TWO_SIDED|90.0|-11.0|4.0|||Wilcoxon rank-sum test|Day 84||||4.0|-11.0|0.509
91635137|NCT02516605|183163117|OTHER||Median difference from baseline|1.5||||0.591|TWO_SIDED|90.0|-5.0|7.0|||Wilcoxon rank-sum test|Day 28||||7.0|-5.0|0.591
91635138|NCT02516605|183163117|OTHER||Median difference from baseline|-2.0||||0.702|TWO_SIDED|90.0|-12.0|4.0|||Wilcoxon rank-sum test|Day 56||||4.0|-12.0|0.702
91635139|NCT02516605|183163117|OTHER||Median difference from baseline|-1.0||||0.838|TWO_SIDED|90.0|-10.0|8.0|||Wilcoxon rank-sum test|Day 84||||8.0|-10.0|0.838
91635140|NCT02516605|183163117|OTHER||Median difference from baseline|4.0||||0.297|TWO_SIDED|90.0|-3.0|8.0|||Wilcoxon rank-sum test|Day 28||||8.0|-3.0|0.297
91635141|NCT02516605|183163117|OTHER||Median difference from baseline|-6.0||||0.236|TWO_SIDED|90.0|-14.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-14.0|0.236
91635142|NCT02516605|183163117|OTHER||Median difference from baseline|-6.5||||0.192|TWO_SIDED|90.0|-15.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-15.0|0.192
91635143|NCT02516605|183163117|OTHER||Median difference from baseline|2.0||||0.605|TWO_SIDED|90.0|-2.0|9.0|||Wilcoxon rank-sum test|Day 28||||9.0|-2.0|0.605
91668504|NCT00706719|183231210|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.109
91668505|NCT01074008|183231213|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
91668506|NCT01074008|183231213|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
91668507|NCT01074008|183231213|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
91668508|NCT01074008|183231213|SUPERIORITY_OR_OTHER|||||||0.009||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.009
91668509|NCT01074008|183231213|SUPERIORITY_OR_OTHER|||||||0.012||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.012
91668510|NCT01074008|183231213|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
91668511|NCT01074008|183231213|SUPERIORITY_OR_OTHER|||||||0.032||||||There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.||||0.032
91484883|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.98|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.98|<0.001
91635144|NCT02516605|183163117|OTHER||Median difference from baseline|-11.0||||0.037|TWO_SIDED|90.0|-21.0|-1.0|||Wilcoxon rank-sum test|Day 56||||-1.0|-21.0|0.037
91635145|NCT02516605|183163117|OTHER||Median difference from baseline|-3.5||||0.397|TWO_SIDED|90.0|-11.0|3.0|||Wilcoxon rank-sum test|Day 84||||3.0|-11.0|0.397
91668512|NCT01074008|183231213|SUPERIORITY_OR_OTHER|||||||0.053||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.053
91668513|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.001
91668514|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.006
91668515|NCT01074008|183231214|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
91668516|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.262
91484884|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.18||0.781|TWO_SIDED|95.0|-0.41|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.41|0.781
91635146|NCT02516605|183163118|OTHER||Median difference from baseline|1.0||||0.342|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|-1.0|0.342
91635147|NCT02516605|183163118|OTHER||Median difference from baseline|0.0||||0.699|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.699
91635148|NCT02516605|183163118|OTHER||Median difference from baseline|-1.0||||0.377|TWO_SIDED|90.0|-3.0|0.0|||Wilcoxon rank-sum test|Day 84||||0.0|-3.0|0.377
91635149|NCT02516605|183163118|OTHER||Median difference from baseline|1.0||||0.132|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|0.0|0.132
91635150|NCT02516605|183163118|OTHER||Median difference from baseline|1.0||||0.292|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|0.0|0.292
91668517|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||1.000
91635151|NCT02516605|183163118|OTHER||Median difference from baseline|0.0||||0.979|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.979
91635152|NCT02516605|183163118|OTHER||Median difference from baseline|2.0||||0.102|TWO_SIDED|90.0|0.0|4.0|||Wilcoxon rank-sum test|Day 28||||4.0|0.0|0.102
91635153|NCT02516605|183163118|OTHER||Median difference from baseline|0.0||||0.717|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.717
91635154|NCT02516605|183163118|OTHER||Median difference|0.0||||1|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|1.000
91635155|NCT02516605|183163118|OTHER||Median difference from baseline|2.0||||0.142|TWO_SIDED|90.0|0.0|5.0|||Wilcoxon rank-sum test|Day 28||||5.0|0.0|0.142
91635156|NCT02516605|183163118|OTHER||Median difference from baseline|0.0||||0.975|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-1.0|0.975
91635157|NCT02516605|183163118|OTHER||Median difference from baseline|0.0||||0.602|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.602
91635158|NCT02516605|183163119|OTHER||Mean difference from baseline|-2.78|STANDARD_ERROR_OF_MEAN|8.436||0.743|TWO_SIDED|90.0|-16.91|11.34|||ANCOVA|Day 7||||11.34|-16.91|0.743
91635159|NCT02516605|183163119|OTHER||Median difference from baseline|-14.07|STANDARD_ERROR_OF_MEAN|8.229||0.093|TWO_SIDED|90.0|-27.85|-0.28|||ANCOVA|Day 14||||-0.28|-27.85|0.093
91635160|NCT02516605|183163119|OTHER||Median difference from baseline|7.78|STANDARD_ERROR_OF_MEAN|8.71||0.376|TWO_SIDED|90.0|-6.81|22.38|||ANCOVA|Day 21||||22.38|-6.81|0.376
91635161|NCT02516605|183163119|OTHER||Median difference from baseline|7.03|STANDARD_ERROR_OF_MEAN|9.187||0.448|TWO_SIDED|90.0|-8.36|22.43|||ANCOVA|Day 28||||22.43|-8.36|0.448
91635162|NCT02516605|183163119|OTHER||Median difference from baseline|-15.25|STANDARD_ERROR_OF_MEAN|7.192||0.039|TWO_SIDED|90.0|-27.3|-3.19|||ANCOVA|Day 56||||-3.19|-27.30|0.039
91635163|NCT02516605|183163119|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.592||0.054|TWO_SIDED|90.0|-31.31|-2.54|||ANCOVA|Day 84||||-2.54|-31.31|0.054
91668518|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.245
91668519|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
91668520|NCT01074008|183231214|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
91668521|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91635164|NCT02516605|183163119|OTHER||Median difference from baseline|11.34|STANDARD_ERROR_OF_MEAN|8.434||0.185|TWO_SIDED|90.0|-2.78|25.46|||ANCOVA|Day 7||||25.46|-2.78|0.185
91635165|NCT02516605|183163119|OTHER||Median difference from baseline|7.74|STANDARD_ERROR_OF_MEAN|8.226||0.351|TWO_SIDED|90.0|-6.05|21.52|||ANCOVA|Day 14||||21.52|-6.05|0.351
91635166|NCT02516605|183163119|OTHER||Median difference from baseline|16.79|STANDARD_ERROR_OF_MEAN|8.707||0.059|TWO_SIDED|90.0|2.2|31.38|||ANCOVA|day 21||||31.38|2.20|0.059
91635167|NCT02516605|183163119|OTHER||Median difference from baseline|14.05|STANDARD_ERROR_OF_MEAN|9.184||0.132|TWO_SIDED|90.0|-1.35|29.44|||ANCOVA|Day 28||||29.44|-1.35|0.132
91635168|NCT02516605|183163119|OTHER||Median difference from baseline|-1.75|STANDARD_ERROR_OF_MEAN|7.19||0.809|TWO_SIDED|90.0|-13.8|10.31|||ANCOVA|Day 56||||10.31|-13.80|0.809
91635169|NCT02516605|183163119|OTHER||Median difference from baseline|-10.9|STANDARD_ERROR_OF_MEAN|8.59||0.21|TWO_SIDED|90.0|-25.29|3.48|||ANCOVA|Day 84||||3.48|-25.29|0.210
91635170|NCT02516605|183163119|OTHER||Median difference from baseline|13.92|STANDARD_ERROR_OF_MEAN|7.963||0.086||90.0|0.58|27.25|||ANCOVA|day 7||||27.25|0.58|0.086
91635171|NCT02516605|183163119|OTHER||Median difference from baseline|0.48|STANDARD_ERROR_OF_MEAN|7.787||0.951|TWO_SIDED|90.0|-12.57|13.53|||ANCOVA|Day 14||||13.53|-12.57|0.951
91635172|NCT02516605|183163119|OTHER||Median difference from baseline|5.02|STANDARD_ERROR_OF_MEAN|8.244||0.545|TWO_SIDED|90.0|-8.79|18.83|||ANCOVA|day 21||||18.83|-8.79|0.545
91635173|NCT02516605|183163119|OTHER||Median difference from baseline|0.19|STANDARD_ERROR_OF_MEAN|8.697||0.982|TWO_SIDED|90.0|-14.38|14.77|||ANCOVA|Day 28||||14.77|-14.38|0.982
91635174|NCT02516605|183163119|OTHER||Median difference from baseline|-13.82|STANDARD_ERROR_OF_MEAN|6.797||0.047|TWO_SIDED|90.0|-25.21|-2.43|||ANCOVA|day 56||||-2.43|-25.21|0.047
91635175|NCT02516605|183163119|OTHER||Median difference from baseline|-18.23|STANDARD_ERROR_OF_MEAN|8.11||0.029|TWO_SIDED|90.0|-31.81|-4.64|||ANCOVA|Day 84||||-4.64|-31.81|0.029
91635176|NCT02516605|183163119|OTHER||Median difference from baseline|26.7|STANDARD_ERROR_OF_MEAN|8.799||0.004|TWO_SIDED|90.0|11.97|41.44|||ANCOVA|Day 7||||41.44|11.97|0.004
91635177|NCT02516605|183163119|OTHER||Median difference from baseline|8.17|STANDARD_ERROR_OF_MEAN|9.032||0.37|TWO_SIDED|90.0|-6.96|23.29|||ANCOVA|Day 14||||23.29|-6.96|0.370
91635178|NCT02516605|183163119|OTHER||Median difference from baseline|5.9|STANDARD_ERROR_OF_MEAN|10.014||0.558|TWO_SIDED|90.0|-10.86|22.66|||ANCOVA|Day 21||||22.66|-10.86|0.558
91635179|NCT02516605|183163119|OTHER||Median difference from baseline|8.91|STANDARD_ERROR_OF_MEAN|10.911||0.418|TWO_SIDED|90.0|-9.34|27.15|||ANCOVA|Day 28||||27.15|-9.34|0.418
91635180|NCT02516605|183163119|OTHER||Median difference from baseline|-11.08|STANDARD_ERROR_OF_MEAN|7.69||0.156|TWO_SIDED|90.0|-23.95|1.8|||ANCOVA|Day 56||||1.80|-23.95|0.156
91635181|NCT02516605|183163119|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.961||0.064|TWO_SIDED|90.0|-31.94|-1.92|||ANCOVA|Day 84||||-1.92|-31.94|0.064
91635182|NCT02643420|183163120|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|-0.148|||<|0.0001|TWO_SIDED|95.0|-0.266|-0.031|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||-0.031|-0.266|<0.0001
91635183|NCT02643420|183163121|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.685|TWO_SIDED|95.0|-1.43|0.94|||Negative binomial regression|||||0.94|-1.43|0.685
91525876|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.094||0.4055|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.11|-0.26|0.4055
91484885|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.71|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.71|0.057
91484886|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.016|TWO_SIDED|95.0|-0.8|-0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.80|0.016
91484887|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.45|TWO_SIDED|95.0|-0.5|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.50|0.450
91484888|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.47|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.47|<0.001
91484889|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
91484890|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.12|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.12|<0.001
91525877|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.111||0.2648|TWO_SIDED|95.0|-0.34|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.34|0.2648
91635184|NCT02643420|183163122|SUPERIORITY||Median Difference (Final Values)|1.2||||0.155|TWO_SIDED|95.0|0.93|1.56|||Asymptotic normality assumption|P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.||||1.56|0.93|0.155
91525878|NCT03502616|182927247|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.099||0.5558|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.25|0.5558
91525879|NCT03502616|182927248|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.513||0.0001|TWO_SIDED|95.0|-3.03|-1.01|||ANCOVA|||Week 16: Analysis performed using Analysis of covariance (ANCOVA) model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-1.01|-3.03|0.0001
91525880|NCT03502616|182927248|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.567||0.027|TWO_SIDED|95.0|-2.38|-0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-2.38|0.0270
91484891|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-1.04|0.001
91484892|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.699|TWO_SIDED|95.0|-0.47|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.47|0.699
91484893|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.408|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.408
91484894|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.74|0.077
91484895|NCT00809354|182843569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.182|TWO_SIDED|95.0|-0.65|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.65|0.182
91484896|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
91484897|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
91635185|NCT02643420|183163123|SUPERIORITY||Percent Difference|1.1||||0.435|TWO_SIDED|95.0|-8.6|10.8|||Fisher Exact|||||10.8|-8.6|0.435
91635186|NCT02643420|183163124|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED|95.0|-0.032|0.116|||t-statistics|||DSN in Cycle 2||0.116|-0.032|<0.0001
91635187|NCT02643420|183163124|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.026|||<|0.0001|TWO_SIDED|95.0|-0.032|0.085|||t-statistics|||DSN in Cycle 3||0.085|-0.032|<0.0001
91484898|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
91484899|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
91484900|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
91484901|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
91484902|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
91484903|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
91484904|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
91484905|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
91484906|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
91484907|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
91484908|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
91484909|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
91484910|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
91484911|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
91484912|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.17||0.005|TWO_SIDED|95.0|-0.82|-0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.82|0.005
91484913|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.05|<0.001
91635188|NCT02643420|183163124|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.027|||<|0.0001|TWO_SIDED|95.0|-0.036|0.089|||t-statistics|||DSN in Cycle 4||0.089|-0.036|<0.0001
91635189|NCT02643420|183163125|SUPERIORITY||Percent Difference|0.3||||1|TWO_SIDED|95.0|-9.5|10.0|||Fisher Exact|||||10.0|-9.5|1.000
91635190|NCT02643420|183163126|SUPERIORITY||Percent Difference|0.0||||1|TWO_SIDED|95.0|-9.7|9.8|||Fisher Exact|||FN in Cycle 2||9.8|-9.7|1.000
91668522|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.059
91668523|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91484914|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.25|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.25|<0.001
91668524|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91635191|NCT02643420|183163126|SUPERIORITY||Percent Difference|1.6||||0.201|TWO_SIDED|95.0|-8.2|11.3|||Fisher Exact|||FN in Cycle 3||11.3|-8.2|0.201
91635192|NCT02643420|183163126|SUPERIORITY||Percent Difference|1.0||||0.232|TWO_SIDED|95.0|-8.7|10.8|||Fisher Exact|||FN in Cycle 4||10.8|-8.7|0.232
91635193|NCT02127970|183163129|NON_INFERIORITY|The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.|Difference|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.|||2.8|-8.5|
91484915|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.23|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.23|<0.001
91635194|NCT04138758|183163166|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.85|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of a first COPD exacerbation.||0.85|0.68|
91635195|NCT04138758|183163167|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.97|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of first hospitalization for community-acquired pneumonia.||0.97|0.57|
91635196|NCT04138758|183163168|OTHER|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.|Hazard Ratio (HR)|0.23|||||TWO_SIDED|95.0|0.19|0.27|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|||0.27|0.19|
91635197|NCT04138758|183163169|OTHER||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.19|0.26|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.||0.26|0.19|
91668525|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.370
91668526|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91484916|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.177|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.177
91484917|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.76|0.014
91484918|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.286|TWO_SIDED|95.0|-0.52|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.52|0.286
91484919|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.952|TWO_SIDED|95.0|-0.33|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.33|0.952
91484920|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.21|-0.95|0.002
91484921|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-0.94|-0.2|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.94|0.003
91484922|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.26|-0.52|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.52|-1.26|<0.001
91484923|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.29|<0.001
91484924|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.972|TWO_SIDED|95.0|-0.36|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.36|0.972
91484925|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.096|TWO_SIDED|95.0|-0.69|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.69|0.096
91484926|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.19||0.069|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.72|0.069
91484927|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.902|TWO_SIDED|95.0|-0.39|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.39|0.902
91484928|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.93|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.93|0.002
91484929|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.61|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.61|-1.33|<0.001
91484930|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.66|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.66|-1.38|<0.001
91484931|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.55|<0.001
91484932|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.028|TWO_SIDED|95.0|-0.75|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.75|0.028
91525881|NCT03502616|182927249|SUPERIORITY||LS mean difference|2.22|STANDARD_ERROR_OF_MEAN|0.841||0.0088|TWO_SIDED|95.0|0.56|3.88|||ANCOVA|||Week 16, Physical Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.88|0.56|0.0088
91635198|NCT04138758|183163170|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.42|0.51|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.51|0.42|
91635199|NCT04138758|183163171|OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.41|0.49|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.49|0.41|
91484933|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.013|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.013
91484934|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.217|TWO_SIDED|95.0|-0.58|0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.58|0.217
91484935|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.18||0.351|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.53|0.351
91525882|NCT03502616|182927249|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|0.939||0.0016|TWO_SIDED|95.0|1.15|4.85|||ANCOVA|||Week 16, Role-Physical: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.85|1.15|0.0016
91635200|NCT02275052|183163184|SUPERIORITY_OR_OTHER||Least squares mean difference|3.31||||0.79|TWO_SIDED|95.0|-21.12|27.74||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||27.74|-21.12|0.790
91635201|NCT02275052|183163185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|||<|0.001|TWO_SIDED|95.0|0.167|0.246|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.246|0.167|<0.001
91525883|NCT03502616|182927249|SUPERIORITY||LS mean difference|4.46|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|2.69|6.23|||ANCOVA|||Week 16, Bodily Pain: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||6.23|2.69|<0.0001
91635202|NCT02275052|183163186|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.346|||<|0.001|TWO_SIDED|95.0|-0.487|-0.204|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||-0.204|-0.487|<0.001
91635203|NCT02275052|183163187|SUPERIORITY_OR_OTHER||Least squares mean difference|0.259|||<|0.001|TWO_SIDED|95.0|0.194|0.324|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.324|0.194|<0.001
91668527|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91635204|NCT01143116|183163200|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
91484936|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.28|-1.05|<0.001
91484937|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.22|-0.45|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.45|-1.22|<0.001
91484938|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.38|-0.62|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.38|<0.001
91484939|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.57|-0.8|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.80|-1.57|<0.001
91525884|NCT03502616|182927249|SUPERIORITY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|0.781|<|0.0001|TWO_SIDED|95.0|1.7|4.78|||ANCOVA|||Week 16, General Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.78|1.70|<0.0001
91635205|NCT01143116|183163200|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
91635206|NCT01143116|183163201|OTHER|||||||0.875|||||||Wilcoxon (Mann-Whitney)|||||||0.8750
91635207|NCT01143116|183163201|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
91635208|NCT01143116|183163202|OTHER|||||||0.0254|||||||Wilcoxon (Mann-Whitney)|||||||0.0254
91635209|NCT01143116|183163202|OTHER|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
91635210|NCT01143116|183163203|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91635211|NCT01143116|183163203|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
91635212|NCT01143116|183163204|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91635213|NCT01143116|183163204|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
91635214|NCT01143116|183163205|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
91635215|NCT01143116|183163206|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
91635216|NCT01143116|183163207|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
91635217|NCT01143116|183163207|OTHER|||||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
91635218|NCT01143116|183163208|OTHER|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
91484940|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.389|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.389
91484941|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.087|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.72|0.087
91525885|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.098||0.1065|TWO_SIDED|95.0|-0.38|3.94|||ANCOVA|||Week 16, Vitality: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.94|-0.38|0.1065
91525886|NCT03502616|182927249|SUPERIORITY||LS mean difference|2.96|STANDARD_ERROR_OF_MEAN|1.059||0.0055|TWO_SIDED|95.0|0.88|5.05|||ANCOVA|||Week 16, Social Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.05|0.88|0.0055
91525887|NCT03502616|182927249|SUPERIORITY||LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|1.289||0.1084|TWO_SIDED|95.0|-0.46|4.61|||ANCOVA|||Week 16, Role-Emotional: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.61|-0.46|0.1084
91525888|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|1.124||0.3379|TWO_SIDED|95.0|-1.13|3.29|||ANCOVA|||Week 16, Mental Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.29|-1.13|0.3379
91525889|NCT03502616|182927249|SUPERIORITY||LS mean difference|3.55|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|95.0|2.09|5.02|||ANCOVA|||Week 16, Physical Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.02|2.09|<0.0001
91525890|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.158||0.2529|TWO_SIDED|95.0|-0.95|3.61|||ANCOVA|||Week 16, Mental Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.61|-0.95|0.2529
91525891|NCT03502616|182927249|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|0.964||0.3744|TWO_SIDED|95.0|-1.04|2.76|||Mixed Models Analysis|||Week 48, Physical Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.76|-1.04|0.3744
91525892|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.083||0.2091|TWO_SIDED|95.0|-0.77|3.5|||Mixed Models Analysis|||Week 48, Role-Physical: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.50|-0.77|0.2091
91525893|NCT03502616|182927249|SUPERIORITY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|1.146||0.0654|TWO_SIDED|95.0|-0.14|4.38|||Mixed Models Analysis|||Week 48, Bodily Pain: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.38|-0.14|0.0654
91525894|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|0.968||0.21|TWO_SIDED|95.0|-0.69|3.12|||Mixed Models Analysis|||Week 48, General Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.12|-0.69|0.2100
91484942|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.072|TWO_SIDED|95.0|-0.74|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.74|0.072
91484943|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.34|TWO_SIDED|95.0|-0.57|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.57|0.340
91525895|NCT03502616|182927249|SUPERIORITY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.248||0.6568|TWO_SIDED|95.0|-1.9|3.01|||Mixed Models Analysis|||Week 48, Vitality: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.90|0.6568
91525896|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.152||0.2288|TWO_SIDED|95.0|-0.88|3.66|||Mixed Models Analysis|||Week 48, Social Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.66|-0.88|0.2288
91484944|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
91635219|NCT01143116|183163208|OTHER|||||||0.6406|||||||Wilcoxon (Mann-Whitney)|||||||0.6406
91635220|NCT01143116|183163209|OTHER|||||||0.4375|||||||Wilcoxon (Mann-Whitney)|||||||0.4375
91635221|NCT01143116|183163209|OTHER|||||||0.2969|||||||Wilcoxon (Mann-Whitney)|||||||0.2969
91635222|NCT01143116|183163210|OTHER|||||||0.5391|||||||Wilcoxon (Mann-Whitney)|||||||0.5391
91635223|NCT01143116|183163210|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
91635224|NCT01143116|183163211|OTHER|||||||0.4766|||||||Wilcoxon (Mann-Whitney)|||||||0.4766
91635225|NCT01143116|183163211|OTHER|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
91635226|NCT01143116|183163212|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
91635227|NCT01143116|183163212|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||||||0.4180
91635228|NCT02630459|183163227|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.58|-1.2||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.20|-2.58|<0.001
91668528|NCT01074008|183231215|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91668529|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
91668530|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
91668531|NCT01074008|183231228|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
91484945|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.39|-1.11|<0.001
91484946|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.42|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.42|<0.001
91484947|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.87|-1.59|<0.001
91484948|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.762|TWO_SIDED|95.0|-0.42|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.42|0.762
91484949|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.19||0.056|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.056
91484950|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.01|TWO_SIDED|95.0|-0.84|-0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.84|0.010
91484951|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.335|TWO_SIDED|95.0|-0.54|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.54|0.335
91484952|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.18|<0.001
91525897|NCT03502616|182927249|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.25||0.4955|TWO_SIDED|95.0|-1.61|3.32|||Mixed Models Analysis|||Week 48, Role-Emotional: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.32|-1.61|0.4955
91668532|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.024
91668533|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.319|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.319
91668534|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
91484953|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.24|-0.44|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.24|<0.001
91484954|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.25|-0.46|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.46|-1.25|<0.001
91484955|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.52|-0.73|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.52|<0.001
91668535|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
91484956|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.782|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.46|0.782
91484957|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.719|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.47|0.719
91484958|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.158|TWO_SIDED|95.0|-0.69|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.69|0.158
91484959|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.67|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.67|0.183
91635229|NCT02630459|183163227|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.31|||<|0.001|TWO_SIDED|95.0|-3.0|-1.62||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.62|-3.00|<0.001
91635230|NCT02630459|183163227|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.25||||0.004|TWO_SIDED|95.0|-2.1|-0.41||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.41|-2.10|0.004
91635231|NCT02630459|183163228|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Full Administration||13.8|-13.3|
91635232|NCT02630459|183163228|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Not Full Administration||13.3|-13.8|
91668536|NCT01074008|183231228|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.074
91484960|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.9|-0.18|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.90|0.004
91484961|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.33|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.05|<0.001
91484962|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.2|0.48|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.48|-1.20|<0.001
91484963|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.48|-0.76|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.76|-1.48|<0.001
91484964|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.408|TWO_SIDED|95.0|-0.51|0.21|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.51|0.408
91484965|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.097|TWO_SIDED|95.0|-0.67|0.06|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.67|0.097
91484966|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.018|TWO_SIDED|95.0|-0.79|-0.07|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.79|0.018
91484967|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.132|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.64|0.132
91484968|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.26|-1.08|0.001
91635233|NCT02630459|183163228|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Discontinued Investigational Product||13.3|-13.8|
91635234|NCT02630459|183163228|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Full Administration||13.8|-13.3|
91668537|NCT03239496|183231252|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 1 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
91484969|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.07|-0.25|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.25|-1.07|0.002
91484970|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.37|-1.19|<0.001
91484971|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.37|-0.55|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.55|-1.37|<0.001
91484972|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.959|TWO_SIDED|95.0|-0.4|0.42|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.42|-0.40|0.959
91484973|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.618|TWO_SIDED|95.0|-0.51|0.31|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.31|-0.51|0.618
91484974|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.149|TWO_SIDED|95.0|-0.71|0.11|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.11|-0.71|0.149
91484975|NCT00809354|182843570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.37|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.22|-0.60|0.370
91484976|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
91484977|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
91484978|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
91484979|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
91484980|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
91484981|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
91484982|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
91484983|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.17||0.371|TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.49|-0.18|0.371
91484984|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.647|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.40|0.647
91484985|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.073|TWO_SIDED|95.0|-0.62|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.62|0.073
91484986|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.55|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.55|0.161
91484987|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.961|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.961
91484988|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.18||0.697|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.42|0.697
91484989|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.139|TWO_SIDED|95.0|-0.62|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.62|0.139
91484990|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.12|TWO_SIDED|95.0|-0.64|0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.64|0.120
91484991|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.637|TWO_SIDED|95.0|-0.44|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.44|0.637
91484992|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.028|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.72|0.028
91484993|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.74|-0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.74|0.024
91484994|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.339|TWO_SIDED|95.0|-0.51|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.51|0.339
91484995|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.381|TWO_SIDED|95.0|-0.5|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.50|0.381
91484996|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.438|TWO_SIDED|95.0|-0.51|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.51|0.438
91484997|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.111|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.66|0.111
91484998|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.059|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.059
91484999|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.282|TWO_SIDED|95.0|-0.57|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.57|0.282
91485000|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.18||0.927|TWO_SIDED|95.0|-0.37|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.37|0.927
91485001|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.65|0.094
91485002|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.012|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.80|0.012
91485003|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.51|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.51|0.363
91485004|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.742|TWO_SIDED|95.0|-0.32|0.45|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.45|-0.32|0.742
91485005|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.19||0.436|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.53|0.436
91525898|NCT03502616|182927249|SUPERIORITY||LS mean difference|0.65|STANDARD_ERROR_OF_MEAN|1.2||0.5888|TWO_SIDED|95.0|-1.71|3.01|||Mixed Models Analysis|||Week 48, Mental Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.71|0.5888
91485006|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.038|TWO_SIDED|95.0|-0.79|-0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.79|0.038
91485007|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.332|TWO_SIDED|95.0|-0.57|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.57|0.332
91485008|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
91485009|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
91485010|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
91485011|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
91485012|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
91485013|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
91485014|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
91485015|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
91485016|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-0.99|<0.001
91485017|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.06|-0.42|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.06|<0.001
91485018|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.29|<0.001
91635235|NCT02630459|183163228|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Not Full Administration||13.3|-13.8|
91635236|NCT02630459|183163228|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Discontinued Investigational Product||13.3|-13.8|
91635237|NCT02630459|183163229|SUPERIORITY||Common Odds Ratio|4.73|||<|0.001|TWO_SIDED|95.0|2.24|9.99||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||9.99|2.24|<0.001
91635238|NCT02630459|183163229|SUPERIORITY||Common Odds Ratio|5.6|||<|0.001|TWO_SIDED|95.0|2.6|12.06||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||12.06|2.60|<0.001
91635239|NCT02630459|183163229|SUPERIORITY||Common Odds Ratio|3.21||||0.009|TWO_SIDED|95.0|1.3|7.88||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||7.88|1.30|0.009
91635240|NCT02630459|183163230|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-2.63|-1.45||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.45|-2.63|<0.001
91635241|NCT02630459|183163230|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.66|-1.49||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.49|-2.66|<0.001
91635242|NCT02630459|183163230|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.07||||0.004|TWO_SIDED|95.0|-1.8|-0.35||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.35|-1.80|0.004
91635243|NCT01797302|183163251|SUPERIORITY|||||||0.88||||||interaction term from model group\*time|Mixed Models Analysis|||||||0.88
91714527|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|7.9||0.0804||95.0|-1.7|29.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||29.4|-1.7|0.0804
91635244|NCT01797302|183163252|SUPERIORITY|||||||0.85||||||interaction term for group\*time|Mixed Models Analysis|||||||0.85
91635245|NCT01797302|183163253|SUPERIORITY|||||||0.61||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.61
91635246|NCT01797302|183163254|SUPERIORITY|||||||0.24||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.24
91485019|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.29|<0.001
91485020|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.95|-0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.25|-0.95|<0.001
91485021|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.32|-1.02|<0.001
91635247|NCT01797302|183163255|SUPERIORITY|||||||0.0117||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0117
91635248|NCT01797302|183163256|SUPERIORITY|||||||0.53||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.53
91485022|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.22|-0.51|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.22|<0.001
91485023|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.6|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.31|<0.001
91485024|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.86|-0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.86|0.003
91485025|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.24|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.24|<0.001
91525899|NCT03502616|182927249|SUPERIORITY||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.896||0.115|TWO_SIDED|95.0|-0.35|3.18|||Mixed Models Analysis|||Week 48, Physical Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.18|-0.35|0.1150
91635249|NCT01797302|183163257|SUPERIORITY|||||||0.0256||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0256
91668538|NCT03239496|183231253|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
91527841|NCT06173570|182930690|SUPERIORITY||Mean Difference (Net)|-28.31|||<|0.001|TWO_SIDED|95.0|-34.42|-22.2|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-22.20|-34.42|< 0.001
91635250|NCT01797302|183163258|SUPERIORITY|||||||0.0945||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0945
91635251|NCT01797302|183163259|SUPERIORITY|||||||0.12||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.12
91635252|NCT01797302|183163260|SUPERIORITY|||||||0.0094||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0094
91668539|NCT03239496|183231254|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
91792602|NCT04641221|183462837|SUPERIORITY|Interaction effect for one-on-one sessions and incentives for participation|incidence rate ratio|1.09||||0.039|TWO_SIDED|90.0|1.02|1.17|||zero-inflated negative binomial||Interaction effect for one-on-one sessions and incentives for participation|There were four potential intervention components. This study used a 2x2x2x2 factorial design. Thus, we analyzed main and interaction effects for the four potential intervention components.||1.17|1.02|0.039
91485026|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.26|-0.57|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.26|<0.001
91485027|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.41|-0.73|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.41|<0.001
91485028|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
91485029|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.47|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.47|-1.21|<0.001
91485030|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.36|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.36|<0.001
91485031|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.83|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.83|-1.56|<0.001
91485032|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.93|-0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.93|0.001
91485033|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
91485034|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
91525900|NCT03502616|182927249|SUPERIORITY||LS mean difference|0.72|STANDARD_ERROR_OF_MEAN|1.158||0.5347|TWO_SIDED|95.0|-1.56|3.0|||Mixed Models Analysis|||Week 48, Mental Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.00|-1.56|0.5347
91525901|NCT03502616|182927250|SUPERIORITY||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|0.898||0.1513|TWO_SIDED|95.0|-0.48|3.06|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.06|-0.48|0.1513
91525902|NCT03502616|182927250|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|1.02||0.1279|TWO_SIDED|95.0|-0.45|3.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.56|-0.45|0.1279
91525903|NCT03502616|182927250|SUPERIORITY||LS mean difference|3.83|STANDARD_ERROR_OF_MEAN|1.056||0.0003|TWO_SIDED|95.0|1.75|5.9|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.90|1.75|0.0003
91525904|NCT03502616|182927250|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.282||0.0102|TWO_SIDED|95.0|0.79|5.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.84|0.79|0.0102
91714528|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|7.94||0.2985||95.0|-7.4|23.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.9|-7.4|0.2985
91525905|NCT03502616|182927250|SUPERIORITY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|1.285||0.0003|TWO_SIDED|95.0|2.2|7.26|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.26|2.20|0.0003
91525906|NCT03502616|182927250|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.439||0.895|TWO_SIDED|95.0|-2.64|3.02|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|-2.64|0.8950
91525907|NCT03502616|182927250|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|1.365||0.4732|TWO_SIDED|95.0|-3.67|1.71|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.71|-3.67|0.4732
91635253|NCT00721136|183163299|OTHER|||||||||||||||||Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|||
91635254|NCT00732199|183163302|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||T- test was conducted to compare the 2 groups.||||<0.05
91635255|NCT00732199|183163303|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Compares control vs hypoxia trials vs recovery post-hypoxia||||||<0.05
91635256|NCT00732199|183163304|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91635257|NCT00732199|183163305|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91792603|NCT04641221|183462837|SUPERIORITY||incident rate ratio|0.86||||0.001|TWO_SIDED|90.0|0.8|0.93||3-way interaction: study videos X one-on-one X incentives for class attendance|Zero-inflated negative binomial||3-way interaction: study videos X one-on-one X incentives for class attendance|There were four potential intervention components. This study used a 2x2x2x2 factorial design. Thus, we analyzed main and interaction effects for the four potential intervention components.||0.93|0.80|0.001
91635258|NCT02274766|183163443|SUPERIORITY||Least Squares Mean Difference|-14.4|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|-20.4|-8.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable; the baseline value is a continuous covariate||32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-8.3|-20.4|<0.0001
91635259|NCT02274766|183163444|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.775||0.0168|TWO_SIDED|95.0|0.35|3.45||Change from Baseline in ON time without troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||3.45|0.35|0.0168
91635260|NCT02274766|183163444|SUPERIORITY||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.648||0.0853|TWO_SIDED|95.0|-2.42|0.16||Change from Baseline in ON time with troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||0.16|-2.42|0.0853
91635261|NCT02274766|183163444|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.461||0.0199|TWO_SIDED|95.0|-2.02|-0.18||Change from Baseline in OFF time.|Linear Mixed Model w/ Repeated Measures|||||-0.18|-2.02|0.0199
91635262|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.9||||0.599|TWO_SIDED|95.0|0.39|2.07||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||2.07|0.39|0.599
91635263|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.07||||0.442|TWO_SIDED|95.0|0.43|2.59||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.59|0.43|0.442
91635264|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.68||||0.823|TWO_SIDED|95.0|0.3|1.57||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.57|0.30|0.823
91635265|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.69|TWO_SIDED|95.0|0.33|1.97||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.97|0.33|0.690
91635266|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.75||||0.764|TWO_SIDED|95.0|0.33|1.71||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.71|0.33|0.764
91635267|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.841|TWO_SIDED|95.0|0.27|1.56||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.56|0.27|0.841
91635268|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.702|TWO_SIDED|95.0|0.35|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7.This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.81|0.35|0.702
91635269|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.91||||0.578|TWO_SIDED|95.0|0.33|2.47||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.47|0.33|0.578
91635270|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.71||||0.783|TWO_SIDED|95.0|0.29|1.7||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.70|0.29|0.783
91635271|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.797|TWO_SIDED|95.0|0.22|1.87||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.87|0.22|0.797
91635272|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.58||||0.919|TWO_SIDED|95.0|0.27|1.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.26|0.27|0.919
91635273|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.55||||0.892|TWO_SIDED|95.0|0.21|1.43||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.43|0.21|0.892
91635274|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.47||||0.86|TWO_SIDED|95.0|0.11|1.93||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.93|0.11|0.860
91635275|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.05||||0.463|TWO_SIDED|95.0|0.38|2.86||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.86|0.38|0.463
91635276|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.35||||0.932|TWO_SIDED|95.0|0.09|1.42||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.42|0.09|0.932
91635277|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.952|TWO_SIDED|95.0|0.16|1.17||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.17|0.16|0.952
91635278|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.873|TWO_SIDED|95.0|0.12|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.81|0.12|0.873
91635279|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.953|TWO_SIDED|95.0|0.16|1.16||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.16|0.16|0.953
91635280|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.26||||0.281|TWO_SIDED|95.0|0.56|2.82||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.82|0.56|0.281
91635281|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.0||||0.5|TWO_SIDED|95.0|0.42|2.35||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||2.35|0.42|0.500
91635282|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.76||||0.744|TWO_SIDED|95.0|0.32|1.77||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||1.77|0.32|0.744
91635283|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.21||||0.334|TWO_SIDED|95.0|0.49|3.04||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||3.04|0.49|0.334
91792604|NCT01903252|183462838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|Risk Difference (RD)|-2.2||||0.005|TWO_SIDED|95.0|-8.1|3.8|||Non-inferiority|||If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.||3.8|-8.1|0.005
91635284|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.698|TWO_SIDED|95.0|0.35|1.85||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.85|0.35|0.698
91635285|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.18||||0.353|TWO_SIDED|95.0|0.48|2.88||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||2.88|0.48|0.353
91635286|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.01||||0.489|TWO_SIDED|95.0|0.45|2.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.26|0.45|0.489
91635287|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.94|TWO_SIDED|95.0|0.17|1.23||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||1.23|0.17|0.940
91635288|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.01||||0.495|TWO_SIDED|95.0|0.42|2.4||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||2.40|0.42|0.495
91635289|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.82||||0.647|TWO_SIDED|95.0|0.28|2.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.37|0.28|0.647
91635290|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.87||||0.646|TWO_SIDED|95.0|0.4|1.86||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.86|0.40|0.646
91635291|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.74||||0.741|TWO_SIDED|95.0|0.29|1.9||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.90|0.29|0.741
91635292|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|2.18||||0.109|TWO_SIDED|95.0|0.62|7.95||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||7.95|0.62|0.109
91635293|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.37||||0.24|TWO_SIDED|95.0|0.55|3.45||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||3.45|0.55|0.240
91635294|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.1||||0.447|TWO_SIDED|95.0|0.27|4.44||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||4.44|0.27|0.447
91635295|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.03||||0.472|TWO_SIDED|95.0|0.39|2.74||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.74|0.39|0.472
91635296|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.78||||0.698|TWO_SIDED|95.0|0.21|2.9||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||2.90|0.21|0.698
91635297|NCT02130635|183163459|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.53||||0.911|TWO_SIDED|95.0|0.21|1.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.37|0.21|0.911
91635298|NCT02417935|183163506|NON_INFERIORITY|If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.|Mean Difference (Final Values)|0.072||||0.7|TWO_SIDED|95.0|-0.295|0.439|||Mixed Models Analysis|||||0.439|-0.295|0.700
91635299|NCT02417935|183163507|OTHER||Mean Difference (Final Values)|-0.2||||0.149|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.149
91635300|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|0.1||||0.535|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||Worst Pain||0.6|-0.3|.535
91635301|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.1||||0.436|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||Least Pain||0.2|-0.5|.436
91635302|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|0.1||||0.534|TWO_SIDED|95.0|-0.2|0.5|||Mixed Models Analysis|||Average Pain||0.5|-0.2|.534
91635303|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|0.0||||0.948|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||Pain Right Now||0.4|-0.4|.948
91635304|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.2||||0.225|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||General Activity||0.1|-0.6|.225
91635305|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.2||||0.276|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||Mood||0.2|-0.6|.276
91635306|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.1||||0.507|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Walking Ability||0.2|-0.4|.507
91635307|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.2||||0.216|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Normal Work||0.1|-0.5|.216
91635308|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.2||||0.233|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||Relations with other people||0.1|-0.4|.233
91635309|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|0.0||||0.857|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Sleep||0.3|-0.3|.857
91792605|NCT01903252|183462839|SUPERIORITY_OR_OTHER||Percentag|75.3|||||TWO_SIDED|95.0|69.4|80.6||||||||80.6|69.4|
91792606|NCT01903252|183462841|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Risk Difference (RD)|-2.1|||<|0.001|TWO_SIDED|95.0|-6.5|2.2|||Non-inferiority|||||2.2|-6.5|<0.001
91792607|NCT01903252|183462842|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.1||||0.026|TWO_SIDED|95.0|-10.1|3.9|||Non-inferiority|||||3.9|-10.1|0.026
91792608|NCT01903252|183462843|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-4.8||||0.048|TWO_SIDED|95.0|-10.9|1.4|||Non-inferiority|||||1.4|-10.9|0.048
91792609|NCT01903252|183462844|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.1|||Non-inferiortiy|||||3.1|-10.8|0.042
91792610|NCT01903252|183462845|NON_INFERIORITY|Non-Inferiority|Risk Difference (RD)|-4.2||||0.048|TWO_SIDED|95.0|-11.0|2.7|||Non-inferiority|||||2.7|-11.0|0.048
91635310|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.2||||0.133|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Enjoyment of life||0.1|-0.5|.133
91635311|NCT02417935|183163508|OTHER||Mean Difference (Final Values)|-0.16||||0.246|TWO_SIDED|95.0|-0.44|0.11|||Mixed Models Analysis|||Average Interference Score||0.11|-0.44|.246
91635312|NCT02417935|183163509|OTHER||Mean Difference (Final Values)|-0.7||||0.627|TWO_SIDED|95.0|-3.6|2.2|||ANCOVA|||Total Score||2.2|-3.6|.627
91635313|NCT02417935|183163509|OTHER||Mean Difference (Final Values)|-0.2||||0.355|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Burning Pain||0.2|-0.6|.355
91635314|NCT02417935|183163509|OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Pressing Pain||0.4|-0.3|.731
91635315|NCT02417935|183163509|OTHER||Mean Difference (Final Values)|0.1||||0.721|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Paroxysmal Pain||0.4|-0.3|.721
91635316|NCT02417935|183163509|OTHER||Mean Difference (Final Values)|-0.2||||0.345|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Evoked Pain||0.2|-0.5|.345
91635317|NCT02417935|183163509|OTHER||Mean Difference (Final Values)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Paresthesia/Dysesthesia||0.3|-0.5|.557
91635318|NCT02417935|183163510|OTHER||Mean Difference (Final Values)|-0.2||||0.106|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis|||||0.0|-0.4|.106
91635319|NCT02417935|183163511|OTHER||Mean Difference (Final Values)|0.014||||0.361|TWO_SIDED|95.0|-0.0161|0.0441|||ANCOVA|||||0.0441|-0.0161|.361
91635320|NCT02417935|183163512|OTHER||Mean Difference (Final Values)|0.2||||0.701|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|.701
91635321|NCT02417935|183163513|OTHER||Mean Difference (Final Values)|0.005||||0.976|TWO_SIDED|95.0|-0.355|0.366|||Mixed Models Analysis|||||0.366|-0.355|.976
91635322|NCT02417935|183163514|OTHER||Mean Difference (Final Values)|0.136||||0.503|TWO_SIDED|95.0|-0.264|0.537|||Mixed Models Analysis|||||0.537|-0.264|.503
91635323|NCT02417935|183163515|OTHER|||||||0.632||||||30% reduction|Fisher Exact|||||||.632
91635324|NCT02417935|183163515|OTHER|||||||0.907|||||||Fisher Exact|||50% Reduction||||.907
91635325|NCT02055976|183163572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.838|STANDARD_ERROR_OF_MEAN|3.775|<|0.001|TWO_SIDED|95.0|-57.335|-42.34|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.340|-57.335|<0.001
91635326|NCT02055976|183163572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.754|STANDARD_ERROR_OF_MEAN|3.912|<|0.001|TWO_SIDED|95.0|-74.523|-58.986|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.986|-74.523|<0.001
91635327|NCT02055976|183163572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.534|STANDARD_ERROR_OF_MEAN|3.903|<|0.001|TWO_SIDED|95.0|-79.284|-63.784|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-63.784|-79.284|<0.001
91635328|NCT02055976|183163572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.531|STANDARD_ERROR_OF_MEAN|4.016|<|0.001|TWO_SIDED|95.0|-55.511|-39.551|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.551|-55.511|<0.001
91635329|NCT02055976|183163572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.624|STANDARD_ERROR_OF_MEAN|3.993|<|0.001|TWO_SIDED|95.0|-70.557|-54.691|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.691|-70.557|<0.001
91635330|NCT02055976|183163572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.268|STANDARD_ERROR_OF_MEAN|3.955|<|0.001|TWO_SIDED|95.0|-72.128|-56.409|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.409|-72.128|<0.001
91635331|NCT02055976|183163573|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.293|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-49.417|-35.168|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.168|-49.417|<0.001
91635332|NCT02055976|183163573|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.262|STANDARD_ERROR_OF_MEAN|3.696|<|0.001|TWO_SIDED|95.0|-63.603|-48.921|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.921|-63.603|<0.001
91635333|NCT02055976|183163573|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.384|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-68.733|-54.035|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.035|-68.733|<0.001
91635334|NCT02055976|183163573|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.578|STANDARD_ERROR_OF_MEAN|4.273|<|0.001|TWO_SIDED|95.0|-56.067|-39.088|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.088|-56.067|<0.001
91485035|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.40|<0.001
91485036|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.40|-1.17|<0.001
91525908|NCT03502616|182927250|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.523||0.6359|TWO_SIDED|95.0|-3.72|2.28|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.28|-3.72|0.6359
91525909|NCT03502616|182927250|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.495||0.6894|TWO_SIDED|95.0|-3.54|2.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.35|-3.54|0.6894
91525910|NCT03502616|182927251|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.141|TWO_SIDED|95.0|-0.46|3.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.24|-0.46|0.1410
91635335|NCT02055976|183163573|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-63.346|STANDARD_ERROR_OF_MEAN|4.244|<|0.001|TWO_SIDED|95.0|-71.776|-54.915|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.915|-71.776|<0.001
91635336|NCT02055976|183163573|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.691|STANDARD_ERROR_OF_MEAN|4.226|<|0.001|TWO_SIDED|95.0|-75.088|-58.295|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.295|-75.088|<0.001
91635337|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-67.254|STANDARD_ERROR_OF_MEAN|4.785|<|0.001|TWO_SIDED|95.0|-76.757|-57.752|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.752|-76.757|<0.001
91668540|NCT03239496|183231255|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
91668541|NCT03239496|183231256|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
91792611|NCT01903252|183462846|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-5.3||||0.068|TWO_SIDED|95.0|-11.5|0.9|||Non-inferiority|||||0.9|-11.5|0.068
91792612|NCT01903252|183462847|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-2.9||||0.021|TWO_SIDED|95.0|-9.8|4.0|||Non-inferiortiy|||||4.0|-9.8|0.021
91485037|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.11|<0.001
91485038|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.32|-0.56|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.32|<0.001
91485039|NCT00809354|182843571|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.51|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.51|<0.001
91485040|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
91485041|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
91485042|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
91485043|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
91485044|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
91485045|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
91485046|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
91485047|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.389|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.47|0.389
91485048|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.035|TWO_SIDED|95.0|-0.68|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.68|0.035
91525911|NCT03502616|182927251|SUPERIORITY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|1.102||0.0122|TWO_SIDED|95.0|0.61|4.95|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.95|0.61|0.0122
91668542|NCT03239496|183231257|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
91668543|NCT03239496|183231258|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
91714529|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.66||0.4991||95.0|-9.9|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-9.9|0.4991
91525912|NCT03502616|182927251|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.252||0.0085|TWO_SIDED|95.0|0.86|5.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.79|0.86|0.0085
91485049|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.155|TWO_SIDED|95.0|-0.56|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.56|0.155
91485050|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.876|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.30|-0.35|0.876
91485051|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.864|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.33|0.864
91485052|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.338|TWO_SIDED|95.0|-0.54|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.54|0.338
91485053|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.101|TWO_SIDED|95.0|-0.66|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.66|0.101
91485054|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.605|TWO_SIDED|95.0|-0.46|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.46|0.605
91485055|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.013|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.78|0.013
91485056|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.84|0.005
91635338|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-87.122|STANDARD_ERROR_OF_MEAN|4.959|<|0.001|TWO_SIDED|95.0|-96.969|-77.275|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-77.275|-96.969|<0.001
91485057|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.199|TWO_SIDED|95.0|-0.57|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.57|0.199
91714530|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|8.15||0.2675||95.0|-7.0|25.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.1|-7.0|0.2675
91485058|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.5|0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.50|0.363
91714531|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1593||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1593
91714532|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.9|STANDARD_ERROR_OF_MEAN|7.96||0.0179||95.0|3.3|34.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||34.6|3.3|0.0179
91485059|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.613|TWO_SIDED|95.0|-0.47|0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.47|0.613
91485060|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.19||0.416|TWO_SIDED|95.0|-0.53|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.53|0.416
91485061|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.143|TWO_SIDED|95.0|-0.66|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.66|0.143
91485062|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.245|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.60|0.245
91635339|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-93.327|STANDARD_ERROR_OF_MEAN|4.949|<|0.001|TWO_SIDED|95.0|-103.153|-83.501|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.501|-103.153|<0.001
91714533|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|8.06||0.0281||95.0|1.9|33.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||33.7|1.9|0.0281
91792613|NCT01903252|183462848|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.4||||0.031|TWO_SIDED|95.0|-10.3|3.7|||Non-inferiortiy|||||3.7|-10.3|0.031
91792614|NCT01903252|183462849|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.7||||0.013|TWO_SIDED|95.0|-9.2|1.8|||Non-inferiority|||||1.8|-9.2|0.013
91485063|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.745|TWO_SIDED|95.0|-0.41|0.29|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|-0.41|0.745
91485064|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.69|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.69|0.062
91485065|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.8|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.80|0.014
91485066|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.367|TWO_SIDED|95.0|-0.52|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.52|0.367
91485067|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.995|TWO_SIDED|95.0|-0.39|0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.39|0.995
91485068|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.735|TWO_SIDED|95.0|-0.46|0.32|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.46|0.735
91485069|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.169|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.67|0.169
91485070|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.295|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.60|0.295
91485071|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
91485072|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
91485073|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
91485074|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
91485075|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
91635340|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.724|STANDARD_ERROR_OF_MEAN|6.243|<|0.001|TWO_SIDED|95.0|-84.128|-59.321|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.321|-84.128|<0.001
91635341|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.206|STANDARD_ERROR_OF_MEAN|6.209|<|0.001|TWO_SIDED|95.0|-108.541|-83.872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.872|-108.541|<0.001
91635342|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.533|STANDARD_ERROR_OF_MEAN|6.145|<|0.001|TWO_SIDED|95.0|-110.743|-86.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.323|-110.743|<0.001
91635343|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.225|STANDARD_ERROR_OF_MEAN|4.736|<|0.001|TWO_SIDED|95.0|-65.63|-46.819|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.819|-65.630|<0.001
91635344|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.813|STANDARD_ERROR_OF_MEAN|4.881|<|0.001|TWO_SIDED|95.0|-83.507|-64.119|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.119|-83.507|<0.001
91635345|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.239|STANDARD_ERROR_OF_MEAN|4.885|<|0.001|TWO_SIDED|95.0|-90.939|-71.538|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.538|-90.939|<0.001
91635346|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.573|STANDARD_ERROR_OF_MEAN|5.983|<|0.001|TWO_SIDED|95.0|-84.461|-60.684|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.684|-84.461|<0.001
91635347|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.222|STANDARD_ERROR_OF_MEAN|5.948|<|0.001|TWO_SIDED|95.0|-108.039|-84.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.405|-108.039|<0.001
91485076|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
91485077|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
91485078|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
91485079|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-0.94|<0.001
91485080|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.09|<0.001
91792615|NCT01903252|183462850|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.0|||Non-inferiority|||||3.0|-10.8|0.042
91792616|NCT01903252|183462851|OTHER||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.557
91714534|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|7.77||0.1883||95.0|-5.0|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|-5.0|0.1883
91714535|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.28||0.23||95.0|-6.3|26.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-6.3|0.2300
91714536|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|7.82||0.7575||95.0|-13.0|17.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.8|-13.0|0.7575
91485081|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.3|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.30|<0.001
91714537|NCT00676403|183320250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|8.02||0.0757||95.0|-1.5|30.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||30.1|-1.5|0.0757
91714538|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.89||0.2817||95.0|-18.0|5.2|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-18.0|0.2817
91714539|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.76||0.6796||95.0|-13.7|9.0|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-13.7|0.6796
91714540|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|6.01||0.2505||95.0|-18.8|4.9|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.9|-18.8|0.2505
91792617|NCT01903252|183462852|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.987
91792618|NCT01903252|183462853|OTHER||Mean Difference (Net)|0.1||||0.455|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided||The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).|||0.2|-0.1|0.455
91792619|NCT01903252|183462854|OTHER||Mean Difference (Net)|0.0||||0.937|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided||The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.|||0.1|-0.1|0.937
91792620|NCT01903252|183462855|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.357
91527842|NCT06173570|182930690|SUPERIORITY||Mean Difference (Net)|-37.25|||<|0.001|TWO_SIDED|95.0|-43.27|-31.23|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-31.23|-43.27|< 0.001
91714541|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.73||0.5102||95.0|-15.1|7.5|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.5|-15.1|0.5102
91792621|NCT01903252|183462856|OTHER||Mean Difference (Net)|-0.1||||0.099|TWO_SIDED|95.0|-0.2|0.0|||t-test, 2 sided|||||0.0|-0.2|0.099
91792622|NCT01903252|183462857|OTHER||Percentage|21.8|||||TWO_SIDED|95.0|16.8|27.5||||||||27.5|16.8|
91792623|NCT01903252|183462858|OTHER||Percentage|60.1|||||TWO_SIDED|95.0|53.6|66.3||||||||66.3|53.6|
91792624|NCT01903252|183462859|OTHER||Percentage|26.3|||||TWO_SIDED|95.0|20.9|32.3||||||||32.3|20.9|
91792625|NCT01903252|183462860|OTHER||Percentage|44.9|||||TWO_SIDED|95.0|38.5|51.3||||||||51.3|38.5|
91792626|NCT01903252|183462861|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
91485082|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.32|-0.67|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.67|-1.32|<0.001
91714542|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.78||0.5706||95.0|-14.7|8.1|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.1|-14.7|0.5706
91714543|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.95||0.4708||95.0|-16.0|7.4|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-16.0|0.4708
91714544|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|5.72||0.6202||95.0|-8.4|14.1|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.1|-8.4|0.6202
91714545|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|6.04||0.4177||95.0|-16.8|7.0|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-16.8|0.4177
91714546|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|5.75||0.6509||95.0|-8.7|13.9|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.9|-8.7|0.6509
91714547|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|5.86||0.8273||95.0|-10.3|12.8|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.8|-10.3|0.8273
91714548|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.94||0.2842||95.0|-18.1|5.3|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.3|-18.1|0.2842
91714549|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.72||0.7041||95.0|-9.1|13.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.5|-9.1|0.7041
91485083|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-1.02|<0.001
91485084|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.99|-0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.99|<0.001
91525913|NCT03502616|182927251|SUPERIORITY||LS mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.416||0.0184|TWO_SIDED|95.0|0.57|6.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.15|0.57|0.0184
91714550|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|6.07||0.7216||95.0|-14.1|9.8|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-14.1|0.7216
91714551|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|5.78||0.6188||95.0|-14.3|8.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-14.3|0.6188
91714552|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.9||0.8096||95.0|-10.2|13.0|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-10.2|0.8096
91485085|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.48|-1.19|<0.001
91525914|NCT03502616|182927251|SUPERIORITY||LS mean difference|4.19|STANDARD_ERROR_OF_MEAN|1.38||0.0026|TWO_SIDED|95.0|1.47|6.91|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.91|1.47|0.0026
91525915|NCT03502616|182927251|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|1.495||0.0236|TWO_SIDED|95.0|0.46|6.35|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.35|0.46|0.0236
91525916|NCT03502616|182927251|SUPERIORITY||LS mean difference|3.66|STANDARD_ERROR_OF_MEAN|1.541||0.0182|TWO_SIDED|95.0|0.63|6.7|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.70|0.63|0.0182
91525917|NCT03502616|182927251|SUPERIORITY||LS mean difference|3.85|STANDARD_ERROR_OF_MEAN|1.545||0.0133|TWO_SIDED|95.0|0.81|6.9|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.90|0.81|0.0133
91525918|NCT03502616|182927251|SUPERIORITY||LS mean difference|3.49|STANDARD_ERROR_OF_MEAN|1.541||0.0245|TWO_SIDED|95.0|0.45|6.52|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.52|0.45|0.0245
91525919|NCT03502616|182927252|SUPERIORITY||LS mean difference|0.81|STANDARD_ERROR_OF_MEAN|0.257||0.0018|TWO_SIDED|95.0|0.3|1.32|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.32|0.30|0.0018
91525920|NCT03502616|182927252|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.301||0.0005|TWO_SIDED|95.0|0.47|1.65|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.47|0.0005
91635348|NCT02055976|183163575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-102.184|STANDARD_ERROR_OF_MEAN|5.919|<|0.001|TWO_SIDED|95.0|-113.945|-90.424|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.424|-113.945|<0.001
91635349|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-69.537|STANDARD_ERROR_OF_MEAN|5.721|<|0.001|TWO_SIDED|95.0|-80.9|-58.175|||Mixed Models Analysis|One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.175|-80.900|<0.001
91668544|NCT03239496|183231259|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
91668545|NCT02339415|183231263|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.26|TWO_SIDED|95.0|-0.06|0.21|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||0.21|-0.06|0.26
91668546|NCT02339415|183231264|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.88|-0.2|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||-0.20|-0.88|0.002
91668547|NCT00003404|183231269|OTHER||rate of occurance|0.35|||||TWO_SIDED|95.0|0.0|8.0|||||The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.|||8|0|
91668548|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.44||||||95.0|0.06|3.43|||ANOVA||The Unadjusted Geometric Mean Ratio (GMR) is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 29||3.43|0.06|
91668549|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.66||||||95.0|0.25|1.7|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 29||1.70|0.25|
91792627|NCT00997113|183462887|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.||||0.940
91714553|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|6.01||0.0157||95.0|-26.5|-2.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-26.5|0.0157
91668550|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.43||||||95.0|0.06|2.94|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 57||2.94|0.06|
91714554|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|5.79||0.6007||95.0|-14.4|8.4|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-14.4|0.6007
91714555|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|6.15||0.1057||95.0|-22.1|2.1|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.1|-22.1|0.1057
91714556|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|5.81||0.7764||95.0|-13.1|9.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-13.1|0.7764
91714557|NCT00676403|183320251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|5.93||0.7146||95.0|-13.9|9.5|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-13.9|0.7146
91714558|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.2978||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.2978
91714559|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7242||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7242
91714560|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.32||0.0773||95.0|-0.1|1.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.1|0.0773
91714561|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7831||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7831
91714562|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3291||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3291
91714563|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3692||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3692
91668551|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.51||||||95.0|0.19|1.37|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 57||1.37|0.19|
91485086|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.29|<0.001
91485087|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.89|-0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.89|0.002
91485088|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.32|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.32|<0.001
91714564|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7614||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7614
91792628|NCT00645788|183462890|SUPERIORITY_OR_OTHER|||||||0.076|||||||ANCOVA|||"Ho: \|Cipro 32.5 mg - matching placebo\|=0 and \|Cipro 48.75 mg - matching placebo\|=0"||||0.076
91668552|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.59||||||95.0|0.13|2.65|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 85||2.65|0.13|
91668553|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.66||||||95.0|0.3|1.43|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 85||1.43|0.30|
91668554|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.96||||||95.0|0.18|5.12|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 169||5.12|0.18|
91668555|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.76||||||95.0|0.36|1.6|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 169||1.60|0.36|
91668556|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.16||||||95.0|0.23|5.79|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 197||5.79|0.23|
91668557|NCT05480800|183231291|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.9||||||95.0|0.44|1.84|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG, Day 197||1.84|0.44|
91668558|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|2.92||||||95.0|0.48|17.8|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 29||17.80|0.48|
91668559|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.95||||||95.0|0.41|2.19|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 29||2.19|0.41|
91668560|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|3.03||||||95.0|0.43|21.45|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 57||21.45|0.43|
91668561|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.89||||||95.0|0.33|2.45|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 57||2.45|0.33|
91714565|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0355||95.0|0.0|1.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0355
91792629|NCT00645788|183462892|SUPERIORITY_OR_OTHER|||||||0.068|||||||ANCOVA|||"At visit 7 (End of treatment) Ho: \|Cipro 32.5 - matching placebo\| =0 and~\|Cipro 48.75 - matching placebo\| =0"||||0.068
91792630|NCT04268823|183462931|SUPERIORITY||Least Squares mean|-0.203|STANDARD_ERROR_OF_MEAN|0.1938||0.298|TWO_SIDED|80.0|-0.524|0.119|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.119|-0.524|0.298
91792631|NCT04268823|183462932|SUPERIORITY||Least Squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.651|TWO_SIDED|80.0|-0.9|0.5|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.5|-0.9|0.651
91792632|NCT04268823|183462933|SUPERIORITY||Least Squares mean|-1.39|STANDARD_ERROR_OF_MEAN|1.29||0.288|TWO_SIDED|80.0|-3.55|0.78|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.78|-3.55|0.288
91668562|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.69||||||95.0|0.26|10.96|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 85||10.96|0.26|
91525921|NCT03502616|182927252|SUPERIORITY||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.305||0.0001|TWO_SIDED|95.0|0.59|1.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.79|0.59|0.0001
91525922|NCT03502616|182927252|SUPERIORITY||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.09|2.17|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.17|1.09|<0.0001
91525923|NCT03502616|182927252|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001|TWO_SIDED|95.0|1.2|2.55|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.55|1.20|<0.0001
91525924|NCT03502616|182927252|SUPERIORITY||LS mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.353||0.0075|TWO_SIDED|95.0|0.26|1.65|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.26|0.0075
91525925|NCT03502616|182927252|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.403||0.1489|TWO_SIDED|95.0|-0.21|1.38|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.21|0.1489
91525926|NCT03502616|182927252|SUPERIORITY||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.417||0.0609|TWO_SIDED|95.0|-0.04|1.61|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.61|-0.04|0.0609
91525927|NCT03502616|182927252|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.429||0.4822|TWO_SIDED|95.0|-0.54|1.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.15|-0.54|0.4822
91525928|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.131||0.0047|TWO_SIDED|95.0|0.12|0.63|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.63|0.12|0.0047
91525929|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.131||0.0001|TWO_SIDED|95.0|0.26|0.77|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.77|0.26|0.0001
91525930|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.148||0.0012|TWO_SIDED|95.0|0.19|0.78|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.78|0.19|0.0012
91525931|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.142||0.0008|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|0.20|0.0008
91668563|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.76||||||95.0|0.29|2.0|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 85||2.00|0.29|
91668564|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|2.49||||||95.0|0.24|26.3|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 169||26.30|0.24|
91668565|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.74||||||95.0|0.26|2.11|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 169||2.11|0.26|
91668566|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.53||||||95.0|0.19|12.41|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 197||12.41|0.19|
91792633|NCT04268823|183462934|SUPERIORITY||Least Squares mean|4.2|STANDARD_ERROR_OF_MEAN|4.336||0.338|TWO_SIDED|80.0|-3.09|11.48|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||11.48|-3.09|0.338
91792634|NCT04268823|183462935|SUPERIORITY||Least Squares mean|-0.82|STANDARD_ERROR_OF_MEAN|3.147||0.795|TWO_SIDED|80.0|-6.05|4.42|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Total score||4.42|-6.05|0.795
91635350|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.446|STANDARD_ERROR_OF_MEAN|5.855|<|0.001|TWO_SIDED|95.0|-98.074|-74.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-74.818|-98.074|<0.001
91485089|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.7|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.39|<0.001
91792635|NCT04268823|183462935|SUPERIORITY||Least Squares mean|5.75|STANDARD_ERROR_OF_MEAN|4.155||0.17|TWO_SIDED|80.0|-1.16|12.66|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Symptoms score||12.66|-1.16|0.170
91485090|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.86|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.86|-1.55|<0.001
91635351|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.273|STANDARD_ERROR_OF_MEAN|5.898|<|0.001|TWO_SIDED|95.0|-109.983|-86.563|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.563|-109.983|<0.001
91635352|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.435|STANDARD_ERROR_OF_MEAN|7.209|<|0.001|TWO_SIDED|95.0|-85.757|-57.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.112|-85.757|<0.001
91635353|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-94.959|STANDARD_ERROR_OF_MEAN|7.236|<|0.001|TWO_SIDED|95.0|-109.333|-80.585|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-80.585|-109.333|<0.001
91635354|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.519|STANDARD_ERROR_OF_MEAN|7.15|<|0.001|TWO_SIDED|95.0|-112.727|-84.311|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.311|-112.727|<0.001
91635355|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.191|STANDARD_ERROR_OF_MEAN|5.741|<|0.001|TWO_SIDED|95.0|-66.592|-43.791|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-43.791|-66.592|<0.001
91635356|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.211|STANDARD_ERROR_OF_MEAN|5.848|<|0.001|TWO_SIDED|95.0|-83.825|-60.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.597|-83.825|<0.001
91635357|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-83.065|STANDARD_ERROR_OF_MEAN|5.913|<|0.001|TWO_SIDED|95.0|-94.807|-71.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.323|-94.807|<0.001
91635358|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.879|STANDARD_ERROR_OF_MEAN|6.678|<|0.001|TWO_SIDED|95.0|-87.147|-60.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.612|-87.147|<0.001
91635359|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.428|STANDARD_ERROR_OF_MEAN|6.697||0.001|TWO_SIDED|95.0|-108.732|-82.124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-82.124|-108.732|0.001
91635360|NCT02055976|183163577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-104.859|STANDARD_ERROR_OF_MEAN|6.654|<|0.001|TWO_SIDED|95.0|-118.079|-91.639|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-91.639|-118.079|<0.001
91635361|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.642|STANDARD_ERROR_OF_MEAN|2.717|<|0.001|TWO_SIDED|95.0|-37.039|-26.246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.246|-37.039|<0.001
91792636|NCT04268823|183462935|SUPERIORITY||Least Squares mean|-0.61|STANDARD_ERROR_OF_MEAN|3.259||0.851|TWO_SIDED|80.0|-6.02|4.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Activity score||4.80|-6.02|0.851
91485091|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.18|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.18|<0.001
91635362|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.88|STANDARD_ERROR_OF_MEAN|2.781|<|0.001|TWO_SIDED|95.0|-45.403|-34.358|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.358|-45.403|<0.001
91635363|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.889|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-51.45|-40.329|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.329|-51.450|<0.001
91792637|NCT04268823|183462935|SUPERIORITY||Least Squares mean|-2.07|STANDARD_ERROR_OF_MEAN|4.035||0.61|TWO_SIDED|80.0|-8.78|4.65|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Impact score||4.65|-8.78|0.610
91792638|NCT04268823|183462936|SUPERIORITY||Least Squares mean|0.25|STANDARD_ERROR_OF_MEAN|4.557||0.956|TWO_SIDED|80.0|-7.3|7.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough symptom score||7.80|-7.30|0.956
91792639|NCT04268823|183462936|SUPERIORITY||Least Squares mean|4.22|STANDARD_ERROR_OF_MEAN|4.671||0.369|TWO_SIDED|80.0|-3.55|11.99|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum symptom score||11.99|-3.55|0.369
91485092|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.28|-0.53|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.28|<0.001
91485093|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.33|<0.001
91485094|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.81|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.56|<0.001
91525932|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.147||0.0004|TWO_SIDED|95.0|0.24|0.81|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.81|0.24|0.0004
91525933|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.188||0.0918|TWO_SIDED|95.0|-0.05|0.69|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.69|-0.05|0.0918
91792640|NCT04268823|183462936|SUPERIORITY||Least Squares mean|2.03|STANDARD_ERROR_OF_MEAN|4.001||0.613|TWO_SIDED|80.0|-4.61|8.68|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough impact score||8.68|-4.61|0.613
91485095|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.02|<0.001
91792641|NCT04268823|183462936|SUPERIORITY||Least Squares mean|0.94|STANDARD_ERROR_OF_MEAN|4.518||0.835|TWO_SIDED|80.0|-6.58|8.47|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum impact score||8.47|-6.58|0.835
91792642|NCT04268823|183462938|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.335|TWO_SIDED|80.0|0.0|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|0.0|0.335
91792643|NCT04268823|183462939|SUPERIORITY||Least Squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.645|TWO_SIDED|80.0|-0.1|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|-0.1|0.645
91792644|NCT04268823|183462940|SUPERIORITY||Least Squares mean|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED|80.0|0.8|3.4|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||3.4|0.8|0.010
91792645|NCT02186301|183462955|OTHER||Kaplan-Meier Median|274.0|||||TWO_SIDED|95.0|109.0||Upper Confidence Limit is not available because it cannot be calculated||||||||109|
91792646|NCT02186301|183462955|OTHER||Kaplan-Meier Median|207.0|||||TWO_SIDED|95.0|112.0|260.0||||||||260.0|112.0|
91792647|NCT02186301|183462955|OTHER||Kaplan Meier Median|390.0|||||TWO_SIDED|95.0|282.0|499.0||||||||499.0|282.0|
91792648|NCT02186301|183462956|OTHER||Percentage|25.0|||||TWO_SIDED|95.0|8.7|49.1||||||||49.1|8.7|
91792649|NCT02186301|183462956|OTHER||Percentage|40.0|||||TWO_SIDED|95.0|22.7|59.4||||||||59.4|22.7|
91792650|NCT02186301|183462956|OTHER||Percentage|78.0|||||TWO_SIDED|95.0|64.0|88.5||||||||88.5|64.0|
91792651|NCT02186301|183462957|OTHER||Kaplan Meier Median|225.0|||||TWO_SIDED|95.0|113.0||Upper Confidence Limit is not available because it cannot be calculated.||||||||113|
91792652|NCT02186301|183462957|OTHER||Kaplan Meier Median|195.5|||||TWO_SIDED|95.0|143.0|617.0||||||||617.0|143.0|
91792653|NCT02186301|183462957|OTHER||Kaplan Meier Median|335.0|||||TWO_SIDED|95.0|282.0|480.0||||||||480.0|282.0|
91792654|NCT00749580|183462958|SUPERIORITY_OR_OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
91485096|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.08|-0.37|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.37|-1.08|<0.001
91485097|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.36|-0.65|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.36|<0.001
91485098|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.52|-0.81|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.52|<0.001
91714566|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5068||95.0|-0.4|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.8|-0.4|0.5068
91714567|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0561||95.0|0.0|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0561
91714568|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.31||0.2223||95.0|-0.2|1.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.0|-0.2|0.2223
91714569|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6791||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.6791
91714570|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.32||0.0188||95.0|0.1|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|0.1|0.0188
91714571|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1314||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.1314
91714572|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.31||0.09||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.0900
91714573|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4144||95.0|-0.4|0.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.4|0.4144
91714574|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7699||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7699
91714575|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0406||95.0|0.0|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0406
91714576|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7574||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7574
91792655|NCT05128929|183462960|SUPERIORITY||Mean Difference (Final Values)|0.614||||0.541|TWO_SIDED|95.0|-1.47|2.79|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||"Null: There is no significant difference in the mean primary endpoint (PVR) at 24 weeks between the treatment (H01) and placebo group.~The following analysis utilizes PVR determined by TD."||2.79|-1.47|0.541
91485099|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.29|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.29|<0.001
91485100|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.30|<0.001
91485101|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.36|-0.58|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.36|<0.001
91525934|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.179||0.16|TWO_SIDED|95.0|-0.1|0.61|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.61|-0.10|0.1600
91635364|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.137|STANDARD_ERROR_OF_MEAN|3.006|<|0.001|TWO_SIDED|95.0|-36.11|-24.164|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-24.164|-36.110|<0.001
91635365|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.525|STANDARD_ERROR_OF_MEAN|3.018|<|0.001|TWO_SIDED|95.0|-45.52|-33.531|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.531|-45.520|<0.001
91635366|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.372|STANDARD_ERROR_OF_MEAN|2.983|<|0.001|TWO_SIDED|95.0|-47.299|-35.445|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.445|-47.299|<0.001
91635367|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.374|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-30.717|-20.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-20.032|-30.717|<0.001
91635368|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.49|STANDARD_ERROR_OF_MEAN|2.741|<|0.001|TWO_SIDED|95.0|-38.934|-28.047|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.047|-38.934|<0.001
91635369|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.76|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-44.262|-33.258|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.258|-44.262|<0.001
91635370|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.847|STANDARD_ERROR_OF_MEAN|2.879|<|0.001|TWO_SIDED|95.0|-36.568|-25.127|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.127|-36.568|<0.001
91635371|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.019|STANDARD_ERROR_OF_MEAN|2.887|<|0.001|TWO_SIDED|95.0|-45.754|-34.285|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.285|-45.754|<0.001
91635372|NCT02055976|183163578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.947|STANDARD_ERROR_OF_MEAN|2.869|<|0.001|TWO_SIDED|95.0|-49.647|-38.247|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.247|-49.647|<0.001
91635373|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.118|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|95.0|-47.76|-34.476|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.476|-47.760|<0.001
91635374|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.787|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-61.543|-48.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.032|-61.543|<0.001
91635375|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-60.549|STANDARD_ERROR_OF_MEAN|3.453|<|0.001|TWO_SIDED|95.0|-67.403|-53.694|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.694|-67.403|<0.001
91635376|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.589|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-43.999|-29.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.178|-43.999|<0.001
91525935|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.195||0.6776|TWO_SIDED|95.0|-0.3|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.30|0.6776
91714577|NCT00676403|183320252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|0.0|1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0554
91714578|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.36||0.5409||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5409
91792656|NCT05128929|183462962|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.599|TWO_SIDED|95.0|-4.34|7.27|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (mPAP) at 24 weeks between the treatment (H01) and placebo group.||7.27|-4.34|0.599
91792657|NCT05128929|183462963|SUPERIORITY||Mean Difference (Final Values)|47.26||||0.166|TWO_SIDED|95.0|-21.43|115.95|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (6MWT distance) at 24 weeks between the treatment (H01) and placebo group.||115.95|-21.43|0.166
91525936|NCT03502616|182927253|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5646|TWO_SIDED|95.0|-0.25|0.46|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.46|-0.25|0.5646
91635377|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.683|STANDARD_ERROR_OF_MEAN|3.734|<|0.001|TWO_SIDED|95.0|-62.102|-47.265|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.265|-62.102|<0.001
91635378|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.517|STANDARD_ERROR_OF_MEAN|3.688|<|0.001|TWO_SIDED|95.0|-63.845|-49.189|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.189|-63.845|<0.001
91635379|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.262|STANDARD_ERROR_OF_MEAN|3.196|<|0.001|TWO_SIDED|95.0|-39.608|-26.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.915|-39.608|<0.001
91635380|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.956|STANDARD_ERROR_OF_MEAN|3.239|<|0.001|TWO_SIDED|95.0|-52.388|-39.523|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.523|-52.388|<0.001
91635381|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|3.305|<|0.001|TWO_SIDED|95.0|-58.063|-44.937|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.937|-58.063|<0.001
91635382|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.474|STANDARD_ERROR_OF_MEAN|3.547|<|0.001|TWO_SIDED|95.0|-47.523|-33.426|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.426|-47.523|<0.001
91635383|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.634|STANDARD_ERROR_OF_MEAN|3.549|<|0.001|TWO_SIDED|95.0|-61.685|-47.583|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.583|-61.685|<0.001
91635384|NCT02055976|183163580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.608|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-66.602|-52.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.614|-66.602|<0.001
91635385|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.265|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-50.347|-36.183|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.183|-50.347|<0.001
91635386|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.962|STANDARD_ERROR_OF_MEAN|3.628|<|0.001|TWO_SIDED|95.0|-65.167|-50.758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.758|-65.167|<0.001
91714579|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|5.25||0.823||95.0|-11.5|9.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.2|-11.5|0.8230
91714580|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|5.48||0.2958||95.0|-16.5|5.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.5|0.2958
91714581|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|5.27||0.3708||95.0|-15.1|5.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.7|-15.1|0.3708
91714582|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.27||0.1853||95.0|-17.4|3.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.4|0.1853
91714583|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.41||0.1834||95.0|-17.9|3.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.9|0.1834
91714584|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8711||95.0|-11.1|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-11.1|0.8711
91714585|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.5||0.3252||95.0|-16.3|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-16.3|0.3252
91714586|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|5.28||0.3205||95.0|-15.7|5.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-15.7|0.3205
91714587|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.34||0.0837||95.0|-19.8|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-19.8|0.0837
91714588|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.4||0.8895||95.0|-11.4|9.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.9|-11.4|0.8895
91714589|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.22||0.6469||95.0|-12.7|7.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.9|-12.7|0.6469
91714590|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.53||0.2687||95.0|-17.0|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-17.0|0.2687
91792658|NCT05128929|183462964|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.975|TWO_SIDED|95.0|-8.22|7.98|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (emPHasis-10 score) at 24 weeks between the treatment (H01) and placebo group.||7.98|-8.22|0.975
91792659|NCT05128929|183462965|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.086|TWO_SIDED|95.0|-19.4|1.4|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (SGRQ Score) at 24 weeks between the treatment (H01) and placebo group.||1.4|-19.40|0.086
91635387|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.729|STANDARD_ERROR_OF_MEAN|3.682|<|0.001|TWO_SIDED|95.0|-72.039|-57.419|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.419|-72.039|<0.001
91635388|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.428|STANDARD_ERROR_OF_MEAN|3.535|<|0.001|TWO_SIDED|95.0|-43.451|-29.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.405|-43.451|<0.001
91635389|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.296|STANDARD_ERROR_OF_MEAN|3.538|<|0.001|TWO_SIDED|95.0|-60.325|-46.267|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.267|-60.325|<0.001
91635390|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.489|STANDARD_ERROR_OF_MEAN|3.496|<|0.001|TWO_SIDED|95.0|-62.436|-48.542|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.542|-62.436|<0.001
91635391|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.288|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-42.059|-28.516|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.516|-42.059|<0.001
91668567|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.85||||||95.0|0.34|2.15|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Typhimurium OAg IgG Day 197||2.15|0.34|
91668568|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|5.43||||||95.0|0.61|48.17|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 29||48.17|0.61|
91668569|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.19||||||95.0|0.43|3.26|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 29||3.26|0.43|
91714591|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.31||0.1757||95.0|-17.7|3.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.3|-17.7|0.1757
91485102|NCT00809354|182843572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.2|<|0.01|TWO_SIDED|95.0|-1.57|-0.79|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.79|-1.57|<0.01
91485103|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
91668570|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|5.88||||||95.0|0.58|59.45|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 57||59.45|0.58|
91668571|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.35||||||95.0|0.41|4.45|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 57||4.45|0.41|
91668572|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|4.22||||||95.0|0.48|37.19|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 85||37.19|0.48|
91668573|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.13||||||95.0|0.37|3.48|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 85||3.48|0.37|
91485104|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
91668574|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|13.24||||||95.0|1.02|172.55|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 169||172.55|1.02|
91668575|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.24||||||95.0|0.4|3.88|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 169||3.88|0.40|
91792660|NCT05128929|183462966|SUPERIORITY||Mean Difference (Final Values)|73.92||||0.215|TWO_SIDED|95.0|-45.61|193.46|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (serum HA) at 24 weeks between the treatment (H01) and placebo group.||193.46|-45.61|0.215
91714592|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|5.38||0.0306||95.0|-22.3|-1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.1|-22.3|0.0306
91714593|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.0857||95.0|-20.2|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.2|0.0857
91714594|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|5.28||0.2932||95.0|-16.0|4.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-16.0|0.2932
91714595|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|5.6||0.0613||95.0|-21.6|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-21.6|0.0613
91714596|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.34||0.5431||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5431
91714597|NCT00676403|183320253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|5.41||0.0262||95.0|-22.7|-1.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.4|-22.7|0.0262
91668576|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|5.56||||||95.0|0.53|58.61|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 197||58.61|0.53|
91668577|NCT05480800|183231292|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.37||||||95.0|0.48|3.86|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 197||3.86|0.48|
91668578|NCT05480800|183231296|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.92||||||95.0|0.54|1.58|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG Day 29||1.58|0.54|
91485105|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
91485106|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
91485107|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
91668579|NCT05480800|183231296|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.93||||||95.0|0.54|1.59|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG Day 57||1.59|0.54|
91635392|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.845|STANDARD_ERROR_OF_MEAN|3.456|<|0.001|TWO_SIDED|95.0|-55.709|-41.982|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.982|-55.709|<0.001
91635393|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.114|STANDARD_ERROR_OF_MEAN|3.526|<|0.001|TWO_SIDED|95.0|-62.116|-48.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.112|-62.116|<0.001
91635394|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.045|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-47.118|-32.971|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.971|-47.118|<0.001
91635395|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.81|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-60.883|-46.737|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.737|-60.883|<0.001
91635396|NCT02055976|183163581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.62|STANDARD_ERROR_OF_MEAN|3.533|<|0.001|TWO_SIDED|95.0|-65.64|-51.6|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-51.600|-65.640|<0.001
91635397|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.896|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|3.646|14.145|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.145|3.646|<0.001
91635398|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.429|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|10.141|20.717|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||20.717|10.141|<0.001
91635399|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.321|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|6.959|17.683|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.683|6.959|<0.001
91485108|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
91485109|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
91485110|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
91485111|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.207|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.20|0.207
91485112|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.27|0.020
91668580|NCT05480800|183231296|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.95||||||95.0|0.61|1.49|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG Day 85||1.49|0.61|
91668581|NCT05480800|183231296|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.78||||||95.0|0.45|1.34|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG Day 169||1.34|0.45|
91485113|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.941|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.13|0.941
91485114|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.494|TWO_SIDED|95.0|-0.18|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.18|0.494
91485115|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
91714598|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.44||0.1547||95.0|-18.5|3.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.0|-18.5|0.1547
91792661|NCT05128929|183462967|SUPERIORITY||Mean Difference (Final Values)|231.47||||0.442|TWO_SIDED|95.0|-377.26|840.2|||Mixed Models Analysis|||There is no significant difference in the mean secondary endpoint (NT-proBNP) at 24 weeks between the treatment (H01) and placebo group.||840.20|-377.26|0.442
91714599|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.33||0.2532||95.0|-16.6|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-16.6|0.2532
91714600|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|5.56||0.0848||95.0|-20.6|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.6|0.0848
91714601|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|5.36||0.2424||95.0|-16.8|4.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.3|-16.8|0.2424
91714602|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.35||0.047||95.0|-21.2|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.2|0.0470
91714603|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|5.49||0.1494||95.0|-18.8|2.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.9|-18.8|0.1494
91714604|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5081||95.0|-13.9|6.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-13.9|0.5081
91714605|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.58||0.2141||95.0|-17.9|4.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-17.9|0.2141
91714606|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.37||0.1484||95.0|-18.4|2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.8|-18.4|0.1484
91714607|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|5.42||0.0963||95.0|-19.7|1.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.6|-19.7|0.0963
91792662|NCT03553836|183462977|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.00046|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).|Log Rank||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).|||0.82|0.45|0.00046
91792663|NCT03553836|183462980|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.0|7.3||||||||7.3|1.0|
91792664|NCT03553836|183462981|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|12.9|||||TWO_SIDED|95.0|9.1|16.9||||||||16.9|9.1|
91792665|NCT02604017|183462989|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.|Percentage of Participants|99.7|||||TWO_SIDED|95.0|99.1|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides \>90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|99.1|
91792666|NCT02604017|183462990|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||1.1|-1.1|
91485116|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.467|TWO_SIDED|95.0|-0.18|0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.18|0.467
91485117|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.774|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.774
91485118|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.315|TWO_SIDED|95.0|-0.06|0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.06|0.315
91485119|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.088|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.088
91485120|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.084|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.084
91485121|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.066|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.066
91485122|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.073|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.073
91485123|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.682|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.682
91485124|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.014
91485125|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|-0.28|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.28|0.027
91525937|NCT03502616|182927254|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.7291|TWO_SIDED|95.0|-0.26|0.37|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.37|-0.26|0.7291
91668582|NCT05480800|183231296|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.94||||||95.0|0.63|1.4|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-Vi Ag IgG Day 197||1.40|0.63|
91668583|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Adjusted GMR|0.95||||||95.0|0.69|1.32|||Mixed Models Analysis||Results based on a linear mixed model with fixed effects; denominator degrees of freedom adjusted using Satterthwaite's method.|Anti-S.Typhimurium OAg IgG Day 29|Heterogeneity was observed at baseline for S. Typhimurium in Africa between iNTS - GMMA + TCV Full dose and iNTS-TCV Ful dose, which influenced other timepoints. Hence, adjusted GMRs are presented.|1.32|0.69|
91485126|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.871|TWO_SIDED|95.0|-0.14|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.14|0.871
91485127|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.301
91485128|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.181|TWO_SIDED|95.0|-0.23|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.23|0.181
91485129|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.3|-0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.30|0.013
91485130|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.031|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.031
91485131|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.874|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.874
91714608|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|5.48||0.8519||95.0|-11.8|9.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-11.8|0.8519
91714609|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.3||0.477||95.0|-14.2|6.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.7|-14.2|0.4770
91714610|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|5.61||0.2166||95.0|-18.0|4.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-18.0|0.2166
91714611|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|5.4||0.1062||95.0|-19.4|1.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.9|-19.4|0.1062
91714612|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|5.45||0.0475||95.0|-21.6|-0.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.6|0.0475
91792667|NCT02604017|183462991|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|-0.6|||||TWO_SIDED|95.0|-1.8|0.6||||||Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||0.6|-1.8|
91792668|NCT01277081|183463039|SUPERIORITY_OR_OTHER||Adjusted Mean difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.86|||Repeated Measure Analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment|Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.||0.86|0.58|<0.0001
91714613|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.54||0.0537||95.0|-21.7|0.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-21.7|0.0537
91714614|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.35||0.3153||95.0|-15.9|5.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-15.9|0.3153
91714615|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|5.68||0.0424||95.0|-22.8|-0.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.4|-22.8|0.0424
91714616|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.42||0.3077||95.0|-16.2|5.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.2|0.3077
91792669|NCT01277081|183463040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.||0.72|0.44|<0.0001
91792670|NCT01277081|183463041|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.65|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.||0.65|0.36|<0.0001
91714617|NCT00676403|183320254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|STANDARD_ERROR_OF_MEAN|5.48||0.0224||95.0|-23.4|-1.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.8|-23.4|0.0224
91635400|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.804|STANDARD_ERROR_OF_MEAN|3.041||0.014|TWO_SIDED|95.0|0.761|12.847|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.847|0.761|0.014
91635401|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.565|STANDARD_ERROR_OF_MEAN|3.023|<|0.001|TWO_SIDED|95.0|4.556|16.573|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.573|4.556|<0.001
91635402|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.895|STANDARD_ERROR_OF_MEAN|2.969|<|0.001|TWO_SIDED|95.0|6.993|18.796|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.796|6.993|<0.001
91635403|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.644|STANDARD_ERROR_OF_MEAN|3.266||0.005|TWO_SIDED|95.0|2.157|15.13|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.130|2.157|0.005
91635404|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.708|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|95.0|8.208|21.208|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.208|8.208|<0.001
91668584|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Adjusted GMR|1.01||||||95.0|0.74|1.37|||Mixed Models Analysis||Results based on a linear mixed model with fixed effects; denominator degrees of freedom adjusted using Satterthwaite's method.|Anti-S.Typhimurium OAg IgG Day 57|Heterogeneity was observed at baseline for S. Typhimurium in Africa between iNTS - GMMA + TCV Full dose and iNTS-TCV Ful dose, which influenced other timepoints. Hence, adjusted GMRs are presented.|1.37|0.74|
91668585|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Adjusted GMR|1.04||||||95.0|0.77|1.41|||Mixed Models Analysis||Results based on a linear mixed model with fixed effects; denominator degrees of freedom adjusted using Satterthwaite's method.|Anti-S.Typhimurium OAg IgG Day 85|Heterogeneity was observed at baseline for S. Typhimurium in Africa between iNTS - GMMA + TCV Full dose and iNTS-TCV Ful dose, which influenced other timepoints. Hence, adjusted GMRs are presented.|1.41|0.77|
91635405|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.168|STANDARD_ERROR_OF_MEAN|3.317|<|0.001|TWO_SIDED|95.0|4.58|17.757|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.757|4.580|<0.001
91635406|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.132|STANDARD_ERROR_OF_MEAN|2.609||0.001|TWO_SIDED|95.0|2.947|13.316|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.316|2.947|0.001
91635407|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.23|STANDARD_ERROR_OF_MEAN|2.592|<|0.001|TWO_SIDED|95.0|5.079|15.381|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.381|5.079|<0.001
91635408|NCT02055976|183163583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.767|STANDARD_ERROR_OF_MEAN|2.565||0.014|TWO_SIDED|95.0|0.67|10.864|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.864|0.670|0.014
91635409|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.079|STANDARD_ERROR_OF_MEAN|1.905|<|0.001|TWO_SIDED|95.0|2.296|9.863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.863|2.296|<0.001
91635410|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.786|STANDARD_ERROR_OF_MEAN|1.918|<|0.001|TWO_SIDED|95.0|6.976|14.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.597|6.976|<0.001
91668586|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Adjusted GMR|1.2||||||95.0|0.81|1.77|||Mixed Models Analysis||Results based on a linear mixed model with fixed effects; denominator degrees of freedom adjusted using Satterthwaite's method.|Anti-S.Typhimurium OAg IgG Day 169|Heterogeneity was observed at baseline for S. Typhimurium in Africa between iNTS - GMMA + TCV Full dose and iNTS-TCV Ful dose, which influenced other timepoints. Hence, adjusted GMRs are presented.|1.77|0.81|
91668587|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Adjusted GMR|0.97||||||95.0|0.65|1.44|||Mixed Models Analysis||Results based on a linear mixed model with fixed effects; denominator degrees of freedom adjusted using Satterthwaite's method.|Anti-S.Typhimurium OAg IgG Day 197|Heterogeneity was observed at baseline for S. Typhimurium in Africa between iNTS - GMMA + TCV Full dose and iNTS-TCV Ful dose, which influenced other timepoints. Hence, adjusted GMRs are presented.|1.44|0.65|
91668588|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.82||||||95.0|0.49|1.37|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 29||1.37|0.49|
91668589|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.97||||||95.0|0.59|1.59|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 57||1.59|0.59|
91668590|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|1.03||||||95.0|0.64|1.67|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 85||1.67|0.64|
91668591|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.93||||||95.0|0.56|1.54|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 169||1.54|0.56|
91668592|NCT05480800|183231297|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Unadjusted GMR|0.82||||||95.0|0.51|1.33|||ANOVA||The Unadjusted GMR is the ratio of the geometric means of two groups being compared. Results were based on a linear model for a visit with fixed effect for treatment.|Anti-S.Enteritidis OAg IgG Day 197||1.33|0.51|
91668593|NCT00377156|183231348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-28.2|||<|0.001|TWO_SIDED|90.0|-41.9|-14.4|||Fisher Exact||Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 \[63.5%\] vs 44/48 \[91.7%\],\> respectively. The percent difference was -28.2%; 90% CI, -41.9% to -14.4%; P \< .001).|||-14.4|-41.9|<0.001
91668594|NCT00377156|183231349|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-18.4|||<|0.001|TWO_SIDED|95.0|-29.0|-7.8|||Fisher Exact|||||-7.8|-29.0|<0.001
91668595|NCT00377156|183231350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.9||||0.001|TWO_SIDED|95.0|4.8|19.0|||t-test, 2 sided|||||19.0|4.8|0.001
91668596|NCT00377156|183231351|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.4||||0.04|TWO_SIDED|95.0|-74.4|5.5|||Fisher Exact||The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 \[60%\] vs 17/18 \[94.4%\]. The percent difference was -34.4% (95% CI: -74.4% to 5.5%; P = .04)|||5.5|-74.4|0.04
91668597|NCT00377156|183231352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Regression, Cox|||||1.38|0.75|0.92
91668598|NCT02459418|183231357|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|164.96|||||TWO_SIDED|90.0|137.82|197.45||||||A mixed-effects analysis of variance (ANOVA) model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. Least squares (LS) means and 90% confidence intervals (CIs) for treatment differences on log-scale were obtained and back transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||197.45|137.82|
91668599|NCT02459418|183231358|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|123.15|||||TWO_SIDED|90.0|108.12|140.28||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||140.28|108.12|
91668600|NCT02459418|183231359|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-∞) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS mean ratio|133.68|||||TWO_SIDED|90.0|102.42|174.49||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||174.49|102.42|
91668601|NCT02459418|183231360|OTHER||Median Difference (Net)|7.5|||||TWO_SIDED|90.0|4.5|11.5||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median differences and corresponding 90% CIs were calculated using an exact Hodges-Lehmann estimate.||11.5|4.5|
91635411|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.069|STANDARD_ERROR_OF_MEAN|1.945|<|0.001|TWO_SIDED|95.0|5.206|12.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.932|5.206|<0.001
91635412|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.173||0.014|TWO_SIDED|95.0|0.541|9.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.178|0.541|0.014
91635413|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.331|STANDARD_ERROR_OF_MEAN|2.161|<|0.001|TWO_SIDED|95.0|3.037|11.624|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.624|3.037|<0.001
91668602|NCT02459418|183231362|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|163.0|||||TWO_SIDED|90.0|94.0|282.67||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||282.67|94|
91792671|NCT01277081|183463042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.||0.67|0.38|<0.0001
91485132|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.447|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.447
91668603|NCT02459418|183231363|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|177.17|||||TWO_SIDED|90.0|125.65|249.81||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||249.81|125.65|
91668604|NCT02459418|183231364|OTHER||Median Difference (Net)|2.14|||||TWO_SIDED|90.0|-9.91|12.29||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median difference and corresponding 90% CIs were was calculated using an Exact Hodges-Lehmann estimate with an exact confidence interval.||12.29|-9.91|
91668605|NCT03978598|183231365|NON_INFERIORITY|We used a 15% difference in our primary outcome for the non-inferiority margin as this is the upper end of the estimated prevalence of lactation failure in the literature and is consistent with previous studies (Neifert 2001, Gurtcheff 2011, Turok 2017).|Risk Difference (RD)|3.7|||||ONE_SIDED|95.0|-16.7|||||||To achieve 80% power with a 1-sided type 1 error of 5% utilizing the Z-test (unpooled), 62 participants would be required in each group, for a total of 124 participants. Accounting for expected loss to follow-up of 20%, we aimed to recruit 149 participants and rounded up to final recruitment goal of 150.|The risk-difference between immediate and standard placement in the modified intention-to-treat analysis (mITT) was -0.6% with a -12.8% lower limit of the 95% confidence interval. In the mITT analysis, 78.3% (54/69) and 78.9% (45/57) of participants were breastfeeding at 8 weeks in the immediate and delayed groups, respectively.||-16.7|
91668606|NCT03978598|183231367|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||Baby had trouble sucking or latching||||0.221
91668607|NCT03978598|183231367|OTHER|||||||0.786|||||||Wilcoxon (Mann-Whitney)|||Baby got sick||||0.786
91485133|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.27|0.059
91635414|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.075|STANDARD_ERROR_OF_MEAN|2.122|<|0.001|TWO_SIDED|95.0|4.856|13.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.293|4.856|<0.001
91635415|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.936|STANDARD_ERROR_OF_MEAN|2.266||0.005|TWO_SIDED|95.0|1.435|10.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.437|1.435|0.005
91668608|NCT03978598|183231367|OTHER|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||I was sick||||0.064
91668609|NCT03978598|183231367|OTHER|||||||0.044|||||||Wilcoxon (Mann-Whitney)|||Provider said baby was underweight||||0.044
91668610|NCT03978598|183231367|OTHER|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Insufficient milk||||0.666
91668611|NCT03978598|183231367|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||I had trouble; breast issues||||0.006
91668612|NCT03978598|183231367|OTHER|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||I quit breastfeeding; life issues||||0.476
91668613|NCT03978598|183231368|OTHER|||||||0.717|||||||Wilcoxon (Mann-Whitney)|||Respecting me as a person||||0.717
91792672|NCT01673282|183463052|SUPERIORITY_OR_OTHER||Least Square Mean|-0.24|STANDARD_ERROR_OF_MEAN|0.06|=|0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.||-0.11|-0.36|=0.0003
91485134|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.196|TWO_SIDED|95.0|-0.23|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.23|0.196
91668614|NCT03978598|183231368|OTHER|||||||0.808|||||||Wilcoxon (Mann-Whitney)|||Letting me say what mattered to me about my birth control method||||0.808
91668615|NCT03978598|183231368|OTHER|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||Taking my preferences about my birth control seriously||||0.967
91668616|NCT03978598|183231368|OTHER|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||Giving me enough information to make the best decision about my birth control method||||0.826
91668617|NCT03978598|183231369|OTHER|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||2 weeks postpartum||||0.264
91668618|NCT03978598|183231369|OTHER|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||4 weeks postpartum||||0.414
91668619|NCT03978598|183231369|OTHER|||||||0.482|||||||Wilcoxon (Mann-Whitney)|||8 weeks postpartum||||0.482
91668620|NCT03978598|183231370|OTHER|||||||0.583|||||||Wilcoxon (Mann-Whitney)|||4 weeks postpartum||||0.583
91668621|NCT03978598|183231370|OTHER|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||8 weeks postpartum||||0.062
91668622|NCT03978598|183231370|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||12 weeks postpartum||||0.705
91668623|NCT03978598|183231371|OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||2 weeks postpartum||||0.60
91668624|NCT03978598|183231371|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||4 weeks postpartum||||0.07
91668625|NCT03978598|183231371|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||8 weeks postpartum||||0.36
91714618|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.7|STANDARD_ERROR_OF_MEAN|2.65||0.0646||95.0|0.9|15.0|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.0|0.9|0.0646
91485135|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
91668626|NCT03978598|183231372|OTHER|||||||0.0376|||||||Wilcoxon (Mann-Whitney)|||||||0.0376
91668627|NCT00683592|183231374|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-2.5||||0.009|TWO_SIDED|95.0|-4.4|-0.6|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline MADRS total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.6|-4.4|0.009
91668628|NCT00683592|183231375|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.6||||0.026|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-D 17 total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.2|-3.1|0.026
91668629|NCT00683592|183231376|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Improve|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||The model was an analysis of variance (ANOVA), with terms for treatment group and center. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-0.5|0.004
91668630|NCT00683592|183231377|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.2||||0.037|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-A total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-2.4|0.037
91668631|NCT00683592|183231378|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.134||||0.002|TWO_SIDED|95.0|0.047|0.221|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS response rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.221|0.047|0.002
91668632|NCT00683592|183231379|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.066|TWO_SIDED|95.0|-0.008|0.147|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS remission rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.147|-0.008|0.066
91668633|NCT02697617|183231390|SUPERIORITY|||||||0.024||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.024
91668634|NCT02697617|183231391|SUPERIORITY|||||||0.14||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.14
91668635|NCT02697617|183231393|OTHER||||||||||||||||||comparison by paired t-test|||
91668636|NCT02697617|183231394|SUPERIORITY|||||||0.15||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.15
91668637|NCT02697617|183231395|SUPERIORITY|||||||0.4||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|paired t test|||||||0.4
91668638|NCT05661344|183231406|OTHER||Ratio of adjusted geometric means [%]|104.56|||||TWO_SIDED|90.0|91.89|118.98|||||"Ratio \[%\] = (adjusted geometric mean of mild hepatic impairment / adjusted geometric mean of normal hepatic function matched to mild hepatic impairment)\*100.~Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 13.7"|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||118.98|91.89|
91635416|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.213|STANDARD_ERROR_OF_MEAN|2.271|<|0.001|TWO_SIDED|95.0|5.702|14.724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.724|5.702|<0.001
91485136|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.845|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.845
91635417|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|2.302|<|0.001|TWO_SIDED|95.0|3.484|12.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.629|3.484|<0.001
91635418|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.846|STANDARD_ERROR_OF_MEAN|1.778|<|0.001|TWO_SIDED|95.0|2.312|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|2.312|<0.001
91635419|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.91|STANDARD_ERROR_OF_MEAN|1.766|<|0.001|TWO_SIDED|95.0|3.4|10.421|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.421|3.400|<0.001
91635420|NCT02055976|183163584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.168|STANDARD_ERROR_OF_MEAN|1.748||0.01|TWO_SIDED|95.0|0.693|7.642|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.642|0.693|0.010
91635421|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|0.6289||0.127|TWO_SIDED|95.0|-0.5283|1.97|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.9700|-0.5283|0.127
91635422|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0574|STANDARD_ERROR_OF_MEAN|0.6461||0.053|TWO_SIDED|95.0|-0.2259|2.3406|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3406|-0.2259|0.053
91668639|NCT05661344|183231406|OTHER||Ratio of adjusted geometric means [%]|130.89|||||TWO_SIDED|90.0|89.34|191.75|||||"Ratio \[%\] = (adjusted geometric mean of moderate hepatic impairment / adjusted geometric mean of normal hepatic function matched to moderate hepatic impairment)\*100.~Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 42.0"|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||191.75|89.34|
91792673|NCT05040971|183463064|SUPERIORITY|Week 52 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.|Treatment difference|-11.19|||<|0.0001|TWO_SIDED|95.0|-12.97|-9.42|||ANCOVA|||Treatment policy estimand||-9.42|-12.97|<0.0001
91635423|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2445|STANDARD_ERROR_OF_MEAN|0.6511||0.354|TWO_SIDED|95.0|-1.0486|1.5375|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.5375|-1.0486|0.354
91635424|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8055|STANDARD_ERROR_OF_MEAN|0.8615||0.176|TWO_SIDED|95.0|-0.9066|2.5177|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.5177|-0.9066|0.176
91635425|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0071|STANDARD_ERROR_OF_MEAN|0.8641||0.011|TWO_SIDED|95.0|0.2899|3.7242|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.7242|0.2899|0.011
91635426|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7116|STANDARD_ERROR_OF_MEAN|0.852||0.024|TWO_SIDED|95.0|0.0184|3.4049|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4049|0.0184|0.024
91635427|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8585|STANDARD_ERROR_OF_MEAN|0.7844||0.138|TWO_SIDED|95.0|-0.6992|2.4163|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4163|-0.6992|0.138
91635428|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8807|STANDARD_ERROR_OF_MEAN|0.799||0.137|TWO_SIDED|95.0|-0.7064|2.4678|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4678|-0.7064|0.137
91635429|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2624|STANDARD_ERROR_OF_MEAN|0.8053||0.373|TWO_SIDED|95.0|-1.337|1.8618|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8618|-1.3370|0.373
91635430|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3239|STANDARD_ERROR_OF_MEAN|0.7472||0.333|TWO_SIDED|95.0|-1.1611|1.8089|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8089|-1.1611|0.333
91635431|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.9322|STANDARD_ERROR_OF_MEAN|0.7488||0.006|TWO_SIDED|95.0|0.4441|3.4203|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4203|0.4441|0.006
91714619|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2|STANDARD_ERROR_OF_MEAN|1.58||0.2947||95.0|0.5|9.1|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||9.1|0.5|0.2947
91714620|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|3.1||0.0249||95.0|1.2|17.2|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||17.2|1.2|0.0249
91714621|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.99||0.7671||95.0|0.3|5.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.9|0.3|0.7671
91714622|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|2.9||0.0169||95.0|1.3|15.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.9|1.3|0.0169
91525938|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.184||0.0257|TWO_SIDED|95.0|-0.78|-0.05|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.78|0.0257
91714623|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.74||0.9569||95.0|0.2|4.3|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.3|0.2|0.9569
91525939|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.227||0.0002|TWO_SIDED|95.0|-1.31|-0.42|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.31|0.0002
91635432|NCT02055976|183163586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.834|STANDARD_ERROR_OF_MEAN|0.7442||0.133|TWO_SIDED|95.0|-0.6451|2.313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3130|-0.6451|0.133
91635433|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0813|STANDARD_ERROR_OF_MEAN|2.0411||0.155|TWO_SIDED|95.0|-1.973|6.1356|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.1356|-1.9730|0.155
91635434|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.2608|STANDARD_ERROR_OF_MEAN|2.0965||0.062|TWO_SIDED|95.0|-0.9035|7.425|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.4250|-0.9035|0.062
91635435|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8224|STANDARD_ERROR_OF_MEAN|2.1126||0.349|TWO_SIDED|95.0|-3.3733|5.0182|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.0182|-3.3733|0.349
91668640|NCT05661344|183231407|OTHER||Ratio of adjusted geometric means [%]|83.29|||||TWO_SIDED|90.0|60.47|114.71|||||"Ratio \[%\] = (adjusted geometric mean of mild hepatic impairment / adjusted geometric mean of normal hepatic function matched to mild hepatic impairment)\*100.~Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 34.8"|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||114.71|60.47|
91668641|NCT05661344|183231407|OTHER||Ratio of adjusted geometric means [%]|68.65|||||TWO_SIDED|90.0|46.48|101.41|||||"Ratio \[%\] = (adjusted geometric mean of moderate hepatic impairment / adjusted geometric mean of normal hepatic function matched to moderate hepatic impairment)\*100.~Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 43.0"|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||101.41|46.48|
91668642|NCT05661344|183231408|OTHER||Ratio of adjusted geometric means [%]|105.44|||||TWO_SIDED|90.0|92.36|120.38|||||"Ratio \[%\] = (adjusted geometric mean of mild hepatic impairment / adjusted geometric mean of normal hepatic function matched to mild hepatic impairment)\*100.~Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 14.1"|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||120.38|92.36|
91668643|NCT05661344|183231408|OTHER||Ratio of adjusted geometric means [%]|131.1|||||TWO_SIDED|90.0|89.96|191.05|||||"Ratio \[%\] = (adjusted geometric mean of moderate hepatic impairment / adjusted geometric mean of normal hepatic function matched to moderate hepatic impairment)\*100.~Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 41.4"|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included the effect 'degree of hepatic impairment' as a fixed effect and 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||191.05|89.96|
91668644|NCT05212948|183231409|OTHER|Vaccine Efficacy|Efficacy|34.2||||0.2409|TWO_SIDED|95.0|21.9|44.6||One-sided P-value was calculated to test the null hypothesis, vaccine efficacy ≤30%.|Poisson Regression Model|Robust Error Variance||Vaccine efficacy was calculated with its 95% confidence interval and defined as 1 minus the relative risk (S-268019-b versus placebo), which included the intervention group, baseline age (continuous) as factors as well as the log of the follow-up time as an offset.||44.6|21.9|0.2409
91668645|NCT05347693|183231426|EQUIVALENCE|"Prespecified estimates for sample size calculation~* Equivalence margin: 0.29~* Sample size estimate parameters:~  * Two-group χ² test~ * Significance level (α): 5% (two-sided)~ * Power: 80%~* Assumed proportions with NK (K+ between 3.5 and 5.0 mmol/L, inclusive) at 180 days post-discharge:~  * Arm A: 0.88~ * Arm B: 0.59~Note: Assumed proportions for statistical planning; not actual results."|Odds Ratio (OR)|0.81||||0.558|TWO_SIDED|95.0|0.39|1.66|||Regression, Logistic|Model included response as the dependent variable, and randomised treatment and participant recruitment country as independent factors.|OR \>1 indicated increased odds of K+ between 3.5 and 5.0 mmol/L on SZC compared to SoC.|||1.66|0.39|0.558
91668646|NCT05347693|183231427|EQUIVALENCE|"Prespecified estimates for sample size calculation~* Equivalence margin: 0.262~* Sample size estimate parameters:~  * Log-Rank Test for Equality of Survival Curves~ * α: 5%~ * Power: 80%~* HR (SZC/SoC): 0.329~* Assumed proportions without the main secondary composite outcome (event-free) at 180 days post-discharge~  * Arm A: 83% (17% with the outcome/event of interest)~ * Arm B: 56.8% (43.2% with the outcome/event of interest)~Note: Assumed proportions for statistical planning; not actual results"|Hazard Ratio (HR)|0.92||||0.743|TWO_SIDED|95.0|0.56|1.51|||Regression, Cox|Randomised treatment group and participant recruitment country were used as the independent variables. SoC group used as reference level in Cox model.|An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.|||1.51|0.56|0.743
91714624|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|STANDARD_ERROR_OF_MEAN|2.07||0.0711||95.0|0.9|11.4|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||11.4|0.9|0.0711
91714625|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|1.85||0.1073||95.0|0.8|10.2|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||10.2|0.8|0.1073
91668647|NCT05347693|183231428|EQUIVALENCE|This outcome is unpowered.|Hazard Ratio (HR)|1.02||||0.951|TWO_SIDED|95.0|0.58|1.79|||Regression, Cox|Randomised treatment group and participant recruitment country were used as the independent variables. SoC group used as reference level in Cox model.|An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.|||1.79|0.58|0.951
91668648|NCT05347693|183231429|EQUIVALENCE|This outcome is unpowered.|Incidence rate ratio|1.48|STANDARD_ERROR_OF_MEAN|0.4||0.152|TWO_SIDED|95.0|0.86|2.53|||Negative binomial regression model|Model included the randomised treatment group as the independent variable and duration of time in study as an offset.|A rate ratio \<1 favours SZC compared to SoC.|||2.53|0.86|0.152
91792674|NCT05040971|183463065|SUPERIORITY|Week 52 responses were analysed using a logistic regression model with randomised treatment as factor and baseline glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) as covariates.|Odds Ratio (OR)|19.81|||<|0.0001|TWO_SIDED|95.0|8.68|45.21|||Regression, Logistic|||Treatment policy estimand||45.21|8.68|<0.0001
91714626|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|1.48||0.1583||95.0|0.7|8.1|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||8.1|0.7|0.1583
91714627|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|STANDARD_ERROR_OF_MEAN|2.8||0.0385||95.0|1.1|15.6|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.6|1.1|0.0385
91668649|NCT05347693|183231430|EQUIVALENCE|This outcome is unpowered.|Hazard Ratio (HR)|1.42||||0.515|TWO_SIDED|95.0|0.5|4.35|||Regression, Cox|Randomised treatment group and participant recruitment country were used as the independent variables. SoC group used as reference level in Cox model.|An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.|||4.35|0.50|0.515
91668650|NCT05347693|183231431|EQUIVALENCE|This outcome is unpowered.|Hazard Ratio (HR)|0.41||||0.258|TWO_SIDED|95.0|0.07|1.83|||Regression, Cox|Randomised treatment group and participant recruitment country were used as the independent variables. SoC group used as reference level in Cox model.|An HR \<1 favoured SZC to be associated with a longer time to first component of composite endpoint than SoC.|||1.83|0.07|0.258
91668651|NCT05347693|183231432|EQUIVALENCE|This outcome is unpowered.|Incidence risk ratio|0.42|STANDARD_ERROR_OF_MEAN|0.31||0.239|TWO_SIDED|95.0|0.1|1.81|||Negative binomial regression model|Model included the randomised treatment group as the independent variable and duration of time in study as an offset.|A rate ratio \<1 favours SZC compared to SoC.|||1.81|0.10|0.239
91668652|NCT01884844|183231452|SUPERIORITY|||||||0.89|||||||Fisher Exact|||||||0.89
91668653|NCT03653026|183231471|SUPERIORITY||Adjusted Response Rate Difference|29.0|||<|0.001|TWO_SIDED|95.0|23.2|34.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||34.7|23.2|<0.001
91668654|NCT03653026|183231472|SUPERIORITY||Adjusted Response Rate Difference|35.1|||<|0.001|TWO_SIDED|95.0|28.6|41.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||41.6|28.6|<0.001
91668655|NCT03653026|183231473|SUPERIORITY||Adjusted Response Rate Difference|15.9|||<|0.001|TWO_SIDED|95.0|11.4|20.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||20.3|11.4|<0.001
91668656|NCT03653026|183231474|SUPERIORITY||Adjusted Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|41.7|57.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||57.1|41.7|<0.001
91668657|NCT03653026|183231475|SUPERIORITY||Adjusted Response Rate Difference|37.0|||<|0.001|TWO_SIDED|95.0|28.8|45.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||45.1|28.8|<0.001
91668658|NCT03653026|183231476|SUPERIORITY||Adjusted Response Rate Difference|30.1|||<|0.001|TWO_SIDED|95.0|24.1|36.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - placebo|||36.2|24.1|<0.001
91668659|NCT03653026|183231477|SUPERIORITY||Adjusted Response Rate Difference|27.1|||<|0.001|TWO_SIDED|95.0|19.0|35.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (\<= 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||35.3|19.0|<0.001
91714628|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.09||0.4923||95.0|0.4|6.1|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.1|0.4|0.4923
91714629|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.7169||95.0|0.4|4.4|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.4|0.4|0.7169
91635436|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.3254|STANDARD_ERROR_OF_MEAN|2.7702||0.202|TWO_SIDED|95.0|-3.1801|7.831|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.8310|-3.1801|0.202
91635437|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1048|STANDARD_ERROR_OF_MEAN|2.7784||0.015|TWO_SIDED|95.0|0.5833|11.6263|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.6263|0.5833|0.015
91714630|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.12||0.4156||95.0|0.5|6.2|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.2|0.5|0.4156
91714631|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.04||0.4165||95.0|0.5|5.6|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.6|0.5|0.4165
91635438|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.2393|STANDARD_ERROR_OF_MEAN|2.7396||0.03|TWO_SIDED|95.0|-0.2058|10.6845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.6845|-0.2058|0.030
91635439|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1827|STANDARD_ERROR_OF_MEAN|2.4251||0.185|TWO_SIDED|95.0|-2.6334|6.9988|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.9988|-2.6334|0.185
91635440|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1376|STANDARD_ERROR_OF_MEAN|2.4716||0.195|TWO_SIDED|95.0|-2.7718|7.0469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0469|-2.7718|0.195
91635441|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3113|STANDARD_ERROR_OF_MEAN|2.4909||0.45|TWO_SIDED|95.0|-4.6358|5.2584|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2584|-4.6358|0.450
91635442|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.6078|STANDARD_ERROR_OF_MEAN|2.3322||0.397|TWO_SIDED|95.0|-4.0274|5.2431|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2431|-4.0274|0.397
91635443|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.7096|STANDARD_ERROR_OF_MEAN|2.3367||0.008|TWO_SIDED|95.0|1.0659|10.3532|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.3532|1.0659|0.008
91635444|NCT02055976|183163587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.4558|STANDARD_ERROR_OF_MEAN|2.323||0.147|TWO_SIDED|95.0|-2.1608|7.0724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0724|-2.1608|0.147
91635445|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9203|STANDARD_ERROR_OF_MEAN|1.3242|<|0.001|TWO_SIDED|95.0|-7.5504|-2.2901|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.2901|-7.5504|<0.001
91635446|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1983|STANDARD_ERROR_OF_MEAN|1.3462|<|0.001|TWO_SIDED|95.0|-9.8718|-4.5249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.5249|-9.8718|<0.001
91635447|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3118|STANDARD_ERROR_OF_MEAN|1.3505|<|0.001|TWO_SIDED|95.0|-9.9935|-4.6301|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.6301|-9.9935|<0.001
91635448|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0629|STANDARD_ERROR_OF_MEAN|1.032||0.002|TWO_SIDED|95.0|-5.1132|-1.0125|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.0125|-5.1132|0.002
91635449|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.6209|STANDARD_ERROR_OF_MEAN|1.0367|<|0.001|TWO_SIDED|95.0|-5.6804|-1.5614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5614|-5.6804|<0.001
91635450|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1778|STANDARD_ERROR_OF_MEAN|1.0269|<|0.001|TWO_SIDED|95.0|-6.2184|-2.1372|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.1372|-6.2184|<0.001
91635451|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.2914|STANDARD_ERROR_OF_MEAN|1.2954||0.006|TWO_SIDED|95.0|-5.8649|-0.7178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.7178|-5.8649|0.006
91635452|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3569|STANDARD_ERROR_OF_MEAN|1.3157|<|0.001|TWO_SIDED|95.0|-8.9706|-3.7432|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7432|-8.9706|<0.001
91635453|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3962|STANDARD_ERROR_OF_MEAN|1.3233|<|0.001|TWO_SIDED|95.0|-9.0247|-3.7677|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7677|-9.0247|<0.001
91635454|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9228|STANDARD_ERROR_OF_MEAN|0.9199|<|0.001|TWO_SIDED|95.0|-5.7506|-2.095|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.0950|-5.7506|<0.001
91714632|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.08||0.4673||95.0|0.4|6.0|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.0|0.4|0.4673
91714633|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.72||0.9855||95.0|0.2|4.1|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.1|0.2|0.9855
91635455|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.7094|STANDARD_ERROR_OF_MEAN|0.9244|<|0.001|TWO_SIDED|95.0|-6.5459|-2.8729|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.8729|-6.5459|<0.001
91635456|NCT02055976|183163589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4374|STANDARD_ERROR_OF_MEAN|0.9187|<|0.001|TWO_SIDED|95.0|-6.263|-2.6118|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.6118|-6.2630|<0.001
91635457|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.4492|STANDARD_ERROR_OF_MEAN|10.2401||0.004|TWO_SIDED|95.0|-47.7872|-7.1112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.1112|-47.7872|0.004
91635458|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.5908|STANDARD_ERROR_OF_MEAN|10.4568|<|0.001|TWO_SIDED|95.0|-61.3577|-19.824|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-19.8240|-61.3577|<0.001
91635459|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.163|STANDARD_ERROR_OF_MEAN|10.5402||0.006|TWO_SIDED|95.0|-48.0927|-6.2332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.2332|-48.0927|0.006
91635460|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.1677|STANDARD_ERROR_OF_MEAN|8.8755||0.004|TWO_SIDED|95.0|-41.8023|-6.5332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.5332|-41.8023|0.004
91635461|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.2255|STANDARD_ERROR_OF_MEAN|8.9203||0.017|TWO_SIDED|95.0|-36.9471|-1.5038|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5038|-36.9471|0.017
91635462|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.5155|STANDARD_ERROR_OF_MEAN|8.8387||0.002|TWO_SIDED|95.0|-44.0795|-8.9515|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.9515|-44.0795|0.002
91635463|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.3898|STANDARD_ERROR_OF_MEAN|5.1768|<|0.001|TWO_SIDED|95.0|-28.6698|-8.1097|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.1097|-28.6698|<0.001
91635464|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.7882|STANDARD_ERROR_OF_MEAN|5.264|<|0.001|TWO_SIDED|95.0|-47.2423|-26.3341|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3341|-47.2423|<0.001
91635465|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.8453|STANDARD_ERROR_OF_MEAN|5.3084|<|0.001|TWO_SIDED|95.0|-47.3864|-26.3041|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3041|-47.3864|<0.001
91635466|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.9411|STANDARD_ERROR_OF_MEAN|7.8656|<|0.001|TWO_SIDED|95.0|-48.5748|-17.3075|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.3075|-48.5748|<0.001
91635467|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.3176|STANDARD_ERROR_OF_MEAN|7.9032|<|0.001|TWO_SIDED|95.0|-47.0238|-15.6114|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.6114|-47.0238|<0.001
91668660|NCT03653026|183231478|SUPERIORITY||Adjusted Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|20.9|37.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||37.4|20.9|<0.001
91668661|NCT03653026|183231479|SUPERIORITY||Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.8|46.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||46.1|29.8|<0.001
91668662|NCT03653026|183231480|SUPERIORITY||Least Squares (LS) Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|24.98|37.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||37.36|24.98|<0.001
91668663|NCT03653026|183231481|SUPERIORITY||Adjusted Response Rate Difference|11.3|||<|0.001|TWO_SIDED|95.0|7.2|15.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||15.3|7.2|<0.001
91668664|NCT03653026|183231482|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|4.19|7.73||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||7.73|4.19|<0.001
91668665|NCT02104817|183231517|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.837|TWO_SIDED|95.0|0.9|1.09||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.09|0.90|0.837
91668666|NCT02104817|183231518|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.269|TWO_SIDED|95.0|0.84|1.05||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.05|0.84|0.269
91668667|NCT02104817|183231519|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.93|1.19||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.19|0.93|0.402
91668668|NCT02104817|183231520|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.16||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.16|0.87|0.940
91635468|NCT02055976|183163590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.847|STANDARD_ERROR_OF_MEAN|7.8576|<|0.001|TWO_SIDED|95.0|-48.465|-17.2289|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.2289|-48.4650|<0.001
91525940|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.05|0.0041
91635469|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.663|STANDARD_ERROR_OF_MEAN|1.431|<|0.001|TWO_SIDED|95.0|4.82|10.506|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.506|4.820|<0.001
91635470|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.29|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|6.389|12.19|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.190|6.389|<0.001
91635471|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.255|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.336|10.175|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.175|4.336|<0.001
91635472|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.228|STANDARD_ERROR_OF_MEAN|1.806||0.11|TWO_SIDED|95.0|-1.361|5.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.818|-1.361|0.110
91668669|NCT02104817|183231521|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.092|TWO_SIDED|95.0|0.81|1.02||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.02|0.81|0.092
91668670|NCT02104817|183231522|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.016|TWO_SIDED|95.0|0.75|0.97||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||0.97|0.75|0.016
91525941|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.215||0.0062|TWO_SIDED|95.0|-1.02|-0.17|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.17|-1.02|0.0062
91635473|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.578|STANDARD_ERROR_OF_MEAN|1.815||0.001|TWO_SIDED|95.0|1.972|9.185|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.185|1.972|0.001
91635474|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.712|STANDARD_ERROR_OF_MEAN|1.789||0.005|TWO_SIDED|95.0|1.156|8.268|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.268|1.156|0.005
91635475|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.888|STANDARD_ERROR_OF_MEAN|2.035||0.002|TWO_SIDED|95.0|1.844|9.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.932|1.844|0.002
91635476|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.251|STANDARD_ERROR_OF_MEAN|2.062|<|0.001|TWO_SIDED|95.0|5.153|13.349|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.349|5.153|<0.001
91635477|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.264|STANDARD_ERROR_OF_MEAN|2.072||0.006|TWO_SIDED|95.0|1.147|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|1.147|0.006
91635478|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.065|STANDARD_ERROR_OF_MEAN|1.843||0.004|TWO_SIDED|95.0|1.402|8.728|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.728|1.402|0.004
91668671|NCT02104817|183231523|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.372|TWO_SIDED|95.0|0.9|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.31|0.90|0.372
91668672|NCT02104817|183231524|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.336|TWO_SIDED|95.0|0.89|1.41||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.41|0.89|0.336
91525942|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.255||0.014|TWO_SIDED|95.0|-1.13|-0.13|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.13|-1.13|0.0140
91714634|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.9566||95.0|0.3|3.3|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||3.3|0.3|0.9566
91714635|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.4632||95.0|0.4|6.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.6|0.4|0.4632
91714636|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2042||95.0|0.1|1.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||1.6|0.1|0.2042
91714637|NCT00676403|183320255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|STANDARD_ERROR_OF_MEAN|1.34||0.3382||95.0|0.5|7.5|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||7.5|0.5|0.3382
91714638|NCT00676403|183320256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.3932||95.0|-6.0|15.2|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.2|-6.0|0.3932
91714639|NCT00676403|183320256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1585||95.0|-2.9|17.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-2.9|0.1585
91714640|NCT00676403|183320256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.285||95.0|-4.9|16.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||16.5|-4.9|0.2850
91714641|NCT00676403|183320256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8645||95.0|-9.4|11.1|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||11.1|-9.4|0.8645
91792675|NCT01293799|183463090|SUPERIORITY|Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle. Patients were censored when the PD treatment was stopped.|Hazard Ratio (HR)|0.92||||0.51|TWO_SIDED|95.0|0.71|1.19||The threshold for statistical significance was P = 0.05|Log Rank|Log-rank follow-up was used to compare the peritonitis-free survival curves in the two arms.|Hazard ratio was the ratio between the hazard rate of the retraining group (nominator) and the hazard rate of the control group (denominator).|Time to the first peritonitis episode was analyzed as the cumulative time without peritonitis (peritonitis-free survival) using the Cox proportional hazards regression model from which unadjusted hazard ratios (HRs) were calculated. Actuarial survival curves showing proportions of of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log-rank follow-up was used to compare the two peritonitis-free survival curves.||1.19|0.71|0.51
91635479|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.096|STANDARD_ERROR_OF_MEAN|1.853||0.004|TWO_SIDED|95.0|1.413|8.78|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.780|1.413|0.004
91714642|NCT00676403|183320256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.3031||95.0|-5.0|15.8|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.8|-5.0|0.3031
91714643|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5384||95.0|-13.2|7.0|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.0|-13.2|0.5384
91525943|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.225||0.0035|TWO_SIDED|95.0|-1.11|-0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.22|-1.11|0.0035
91635480|NCT02055976|183163592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.301|STANDARD_ERROR_OF_MEAN|1.832||0.011|TWO_SIDED|95.0|0.658|7.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.943|0.658|0.011
91635481|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.389|STANDARD_ERROR_OF_MEAN|2.525|<|0.001|TWO_SIDED|95.0|8.373|18.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.405|8.373|<0.001
91635482|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.546|STANDARD_ERROR_OF_MEAN|2.576|<|0.001|TWO_SIDED|95.0|11.43|21.663|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.663|11.430|<0.001
91635483|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.288|STANDARD_ERROR_OF_MEAN|2.593|<|0.001|TWO_SIDED|95.0|8.137|18.438|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.438|8.137|<0.001
91635484|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.112|STANDARD_ERROR_OF_MEAN|2.909||0.081|TWO_SIDED|95.0|-1.671|9.895|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.895|-1.671|0.081
91635485|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.56|STANDARD_ERROR_OF_MEAN|2.927|<|0.001|TWO_SIDED|95.0|3.743|15.377|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.377|3.743|<0.001
91668673|NCT02104817|183231525|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.112|TWO_SIDED|95.0|0.97|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.31|0.97|0.112
91525944|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.253||0.0645|TWO_SIDED|95.0|-0.97|0.03|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.97|0.0645
91635486|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.826|STANDARD_ERROR_OF_MEAN|2.878|<|0.001|TWO_SIDED|95.0|4.103|15.548|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.548|4.103|<0.001
91635487|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.004|STANDARD_ERROR_OF_MEAN|3.326||0.002|TWO_SIDED|95.0|3.395|16.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.612|3.395|0.002
91635488|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.252|STANDARD_ERROR_OF_MEAN|3.367|<|0.001|TWO_SIDED|95.0|9.56|22.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.943|9.560|<0.001
91635489|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.571|STANDARD_ERROR_OF_MEAN|3.384||0.003|TWO_SIDED|95.0|2.847|16.295|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.295|2.847|0.003
91635490|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.029|STANDARD_ERROR_OF_MEAN|2.858||0.001|TWO_SIDED|95.0|3.348|14.71|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.710|3.348|0.001
91635491|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.543|STANDARD_ERROR_OF_MEAN|2.876||0.002|TWO_SIDED|95.0|2.827|14.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.260|2.827|0.002
91668674|NCT02104817|183231526|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.091|TWO_SIDED|95.0|0.97|1.42||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.42|0.97|0.091
91668675|NCT02104817|183231527|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.408|TWO_SIDED|95.0|0.83|1.08||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.08|0.83|0.408
91668676|NCT02104817|183231528|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.233|TWO_SIDED|95.0|0.63|1.12||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.12|0.63|0.233
91668677|NCT02104817|183231529|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.81|1.17||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.17|0.81|0.770
91635492|NCT02055976|183163593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.898|STANDARD_ERROR_OF_MEAN|2.84||0.001|TWO_SIDED|95.0|3.252|14.544|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.544|3.252|0.001
91668678|NCT02104817|183231530|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.278|TWO_SIDED|95.0|0.9|1.45||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.45|0.90|0.278
91668679|NCT00715676|183231610|SUPERIORITY_OR_OTHER|||||||0.641||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.641
91668680|NCT00715676|183231610|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.243
91668681|NCT00715676|183231611|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||ANOVA|||||||0.778
91668682|NCT00715676|183231611|SUPERIORITY_OR_OTHER|||||||0.173||95.0|||||ANOVA|||||||0.173
91668683|NCT00715676|183231612|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||ANOVA|||||||0.395
91668684|NCT00715676|183231612|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||ANOVA|||||||0.523
91668685|NCT00715676|183231613|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||ANOVA|||||||0.928
91668686|NCT00715676|183231613|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||ANOVA|||||||0.124
91668687|NCT00715676|183231614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173||||||90.0|0.164|0.181||||||||0.181|0.164|
91714644|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.8015||95.0|-10.9|8.5|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.5|-10.9|0.8015
91525945|NCT03502616|182927254|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.255||0.0341|TWO_SIDED|95.0|-1.05|-0.04|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.05|0.0341
91714645|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.4429||95.0|-14.5|6.4|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.4|-14.5|0.4429
91635493|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.462|STANDARD_ERROR_OF_MEAN|1.434|<|0.001|TWO_SIDED|95.0|-10.311|-4.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.614|-10.311|<0.001
91668688|NCT00715676|183231614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.582||||||90.0|0.573|0.591||||||||0.591|0.573|
91668689|NCT03828539|183231617|OTHER||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.13|0.27|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||0.27|0.13|<.001
91668690|NCT03828539|183231618|OTHER||Odds Ratio (OR)|2.76|||<|0.001|TWO_SIDED|95.0|2.06|3.71|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.71|2.06|<.001
91668691|NCT03828539|183231619|OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|3.12|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.12|1.70|<.001
91668692|NCT03828539|183231620|OTHER||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.26|2.43|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Physical Component Summary (PCS)||2.43|1.26|<0.001
91668693|NCT03828539|183231620|OTHER||Odds Ratio (OR)|1.79||||0.005|TWO_SIDED|95.0|1.29|2.69|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Mental Component Summary (MCS)||2.69|1.29|0.005
91668694|NCT00608634|183231622|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
91668695|NCT00608634|183231622|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91668696|NCT00608634|183231623|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91668697|NCT01841736|183231631|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0005|TWO_SIDED|80.0|0.42|0.69|||Log Rank|Stratified log rank||||0.69|0.42|0.0005
91668698|NCT01841736|183231633|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7|TWO_SIDED|80.0|0.84|1.51|||Log Rank|Stratified Log-Rank||||1.51|0.84|0.7
91668699|NCT00653159|183231639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.||||0.4003
91668700|NCT00653159|183231640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4136|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.||||0.4136
91635494|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.693|STANDARD_ERROR_OF_MEAN|1.469|<|0.001|TWO_SIDED|95.0|-9.61|-3.776|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.776|-9.610|<0.001
91635495|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.755|STANDARD_ERROR_OF_MEAN|1.479|<|0.001|TWO_SIDED|95.0|-11.692|-5.817|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.817|-11.692|<0.001
91635496|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.072|STANDARD_ERROR_OF_MEAN|1.773||0.484|TWO_SIDED|95.0|-3.596|3.451|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.451|-3.596|0.484
91635497|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.701|STANDARD_ERROR_OF_MEAN|1.793||0.173|TWO_SIDED|95.0|-5.264|1.862|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.862|-5.264|0.173
91635498|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.953|STANDARD_ERROR_OF_MEAN|1.761||0.135|TWO_SIDED|95.0|-5.452|1.546|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.546|-5.452|0.135
91635499|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.447|STANDARD_ERROR_OF_MEAN|2.406||0.034|TWO_SIDED|95.0|-9.23|0.335|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.335|-9.230|0.034
91668701|NCT00653159|183231641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4783|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.||||0.4783
91525946|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.056||0.0001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.33|0.0001
91635500|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.764|STANDARD_ERROR_OF_MEAN|2.442||0.003|TWO_SIDED|95.0|-11.617|-1.91|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.910|-11.617|0.003
91635501|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.951|STANDARD_ERROR_OF_MEAN|2.458||0.009|TWO_SIDED|95.0|-10.836|-1.066|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.066|-10.836|0.009
91635502|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.915||0.056|TWO_SIDED|95.0|-6.876|0.736|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.736|-6.876|0.056
91635503|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.557|STANDARD_ERROR_OF_MEAN|1.937||0.095|TWO_SIDED|95.0|-6.408|1.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.293|-6.408|0.095
91635504|NCT02055976|183163595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.271|STANDARD_ERROR_OF_MEAN|1.913||0.004|TWO_SIDED|95.0|-9.074|-1.469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.469|-9.074|0.004
91635505|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.88|STANDARD_ERROR_OF_MEAN|7.071|<|0.001|TWO_SIDED|95.0|-45.925|-17.836|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.836|-45.925|<0.001
91668702|NCT00653159|183231642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2174|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.||||0.2174
91635506|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.187|STANDARD_ERROR_OF_MEAN|7.242|<|0.001|TWO_SIDED|95.0|-43.571|-14.803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.803|-43.571|<0.001
91635507|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.657|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-54.136|-25.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.178|-54.136|<0.001
91635508|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.681|STANDARD_ERROR_OF_MEAN|13.601||0.366|TWO_SIDED|95.0|-31.713|22.35|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.350|-31.713|0.366
91635509|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.227|STANDARD_ERROR_OF_MEAN|13.586||0.773|TWO_SIDED|95.0|-16.774|37.228|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||37.228|-16.774|0.773
91635510|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.646|STANDARD_ERROR_OF_MEAN|13.362||0.422|TWO_SIDED|95.0|-29.206|23.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||23.915|-29.206|0.422
91635511|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.911|STANDARD_ERROR_OF_MEAN|10.309||0.107|TWO_SIDED|95.0|-33.411|7.589|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.589|-33.411|0.107
91635512|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.119|STANDARD_ERROR_OF_MEAN|10.461||0.015|TWO_SIDED|95.0|-43.923|-2.315|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.315|-43.923|0.015
91635513|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.159|STANDARD_ERROR_OF_MEAN|10.535||0.054|TWO_SIDED|95.0|-38.108|3.789|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.789|-38.108|0.054
91635514|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.416|STANDARD_ERROR_OF_MEAN|12.718||0.029|TWO_SIDED|95.0|-49.696|0.865|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.865|-49.696|0.029
91635515|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.287|STANDARD_ERROR_OF_MEAN|12.705||0.311|TWO_SIDED|95.0|-31.541|18.968|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.968|-31.541|0.311
91635516|NCT02055976|183163596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.443|STANDARD_ERROR_OF_MEAN|12.555||0.006|TWO_SIDED|95.0|-57.4|-7.485|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.485|-57.400|0.006
91635517|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.967|STANDARD_ERROR_OF_MEAN|10.822|<|0.001|TWO_SIDED|95.0|-57.463|-14.472|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.472|-57.463|<0.001
91635518|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.186|STANDARD_ERROR_OF_MEAN|11.044||0.005|TWO_SIDED|95.0|-51.123|-7.249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.249|-51.123|0.005
91635519|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|11.16|<|0.001|TWO_SIDED|95.0|-62.175|-17.845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.845|-62.175|<0.001
91635520|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.17|STANDARD_ERROR_OF_MEAN|10.906||0.614|TWO_SIDED|95.0|-18.502|24.842|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||24.842|-18.502|0.614
91635521|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.563|STANDARD_ERROR_OF_MEAN|11.067||0.221|TWO_SIDED|95.0|-30.554|13.427|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.427|-30.554|0.221
91635522|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.649|STANDARD_ERROR_OF_MEAN|10.933||0.303|TWO_SIDED|95.0|-27.376|16.079|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.079|-27.376|0.303
91668703|NCT00653159|183231643|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|Two-sided test||"Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied (happy or very happy) at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types."||||1.0000
91668704|NCT01848210|183231648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65||||0.531|TWO_SIDED|95.0|-19.81|10.51|||Regression, Linear|||||10.51|-19.81|0.531
91668705|NCT00381849|183231652|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.||||0.32
91668706|NCT00381849|183231652|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.||||0.23
91668707|NCT00381849|183231652|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.41
91714646|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.886||95.0|-10.5|9.1|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.1|-10.5|0.8860
91714647|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9963||95.0|-10.0|9.9|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.9|-10.0|0.9963
91792676|NCT01293799|183463091|OTHER|The number of peritonitis events between the two groups was tested by assuming a Poisson distribution of the number of events per follow-up time, log (follow-up time) as offset time, by using generalized linear models.|Risk Ratio (RR)|0.92||||0.51|TWO_SIDED|95.0|0.7|1.19||P-value \<0.05 is regarded as significant.|Generalized linear methods||In calculation of the Risk Ratio, data for the Retraining group represents the nominator and data for the Control group represents the denominator.|||1.19|0.70|0.51
91525947|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-0.47|<0.0001
91714648|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9||||0.3421||95.0|-6.3|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-6.3|0.3421
91714649|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2849||95.0|-5.4|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-5.4|0.2849
91635523|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.003|STANDARD_ERROR_OF_MEAN|14.53||0.067|TWO_SIDED|95.0|-50.882|6.875|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.875|-50.882|0.067
91635524|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.761|STANDARD_ERROR_OF_MEAN|14.676||0.003|TWO_SIDED|95.0|-70.934|-12.588|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-12.588|-70.934|0.003
91668708|NCT00381849|183231652|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.||||0.32
91668709|NCT00381849|183231653|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.||||0.49
91668710|NCT00381849|183231653|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.||||0.64
91668711|NCT00381849|183231653|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.72
91668712|NCT00381849|183231653|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.||||0.84
91668713|NCT00381849|183231656|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.||||0.69
91668714|NCT00381849|183231656|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.||||0.25
91485137|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
91635525|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.933|STANDARD_ERROR_OF_MEAN|14.832||0.01|TWO_SIDED|95.0|-64.41|-5.456|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.456|-64.410|0.010
91635526|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.978|STANDARD_ERROR_OF_MEAN|11.725||0.064|TWO_SIDED|95.0|-41.282|5.326|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.326|-41.282|0.064
91635527|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.654|STANDARD_ERROR_OF_MEAN|11.903||0.318|TWO_SIDED|95.0|-29.311|18.004|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.004|-29.311|0.318
91635528|NCT02055976|183163598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.435|STANDARD_ERROR_OF_MEAN|11.807||0.052|TWO_SIDED|95.0|-42.902|4.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.032|-42.902|0.052
91635529|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.974|STANDARD_ERROR_OF_MEAN|7.674|<|0.001|TWO_SIDED|95.0|-41.217|-10.731|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-10.731|-41.217|<0.001
91635530|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.11|STANDARD_ERROR_OF_MEAN|7.831||0.004|TWO_SIDED|95.0|-36.665|-5.555|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.555|-36.665|0.004
91635531|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.034|STANDARD_ERROR_OF_MEAN|7.917|<|0.001|TWO_SIDED|95.0|-46.758|-15.31|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.310|-46.758|<0.001
91635532|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.034|STANDARD_ERROR_OF_MEAN|9.553||0.799|TWO_SIDED|95.0|-10.948|27.015|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||27.015|-10.948|0.799
91635533|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.511|STANDARD_ERROR_OF_MEAN|9.682||0.398|TWO_SIDED|95.0|-21.748|16.727|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.727|-21.748|0.398
91635534|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.369|STANDARD_ERROR_OF_MEAN|9.58||0.515|TWO_SIDED|95.0|-18.668|19.407|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||19.407|-18.668|0.515
91635535|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.056|STANDARD_ERROR_OF_MEAN|8.801||0.128|TWO_SIDED|95.0|-27.549|7.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.437|-27.549|0.128
91485138|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
91485139|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
91635536|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.352|STANDARD_ERROR_OF_MEAN|8.882||0.004|TWO_SIDED|95.0|-42.008|-6.695|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.695|-42.008|0.004
91635537|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.994|STANDARD_ERROR_OF_MEAN|8.987||0.049|TWO_SIDED|95.0|-32.858|2.87|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.870|-32.858|0.049
91668715|NCT00381849|183231656|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.15
91668716|NCT00381849|183231656|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.||||0.20
91668717|NCT00381849|183231657|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.85
91668718|NCT00381849|183231657|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.63
91668719|NCT00381849|183231657|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.97
91668720|NCT00381849|183231657|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.15
91668721|NCT00381849|183231658|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.81
91668722|NCT00381849|183231658|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.78
91668723|NCT00381849|183231658|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.96
91668724|NCT00381849|183231658|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.13
91668725|NCT02003222|183231779|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.003|TWO_SIDED|95.0|0.25|0.76|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||0.76|0.25|0.003
91668726|NCT02003222|183231780|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015|TWO_SIDED|95.0|0.31|0.89|||Log Rank||hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone|||0.89|0.31|0.015
91668727|NCT02003222|183231781|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.67|TWO_SIDED|95.0|0.22|2.65|||Log Rank|||||2.65|0.22|0.67
91668728|NCT02003222|183231782|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.28|3.63|||Log Rank|||||3.63|0.28|1.00
91668729|NCT02003222|183231783|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.41|TWO_SIDED|95.0|0.17|2.11|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||2.11|0.17|0.41
91668730|NCT03302078|183231837|OTHER||Geometric Mean (T/R) ratio (%)|102.63|||||TWO_SIDED|90.0|98.31|107.15|||||To get geometric mean ratio and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variance (%) = 5.5|The analysis of variance (ANOVA) model on a logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||107.15|98.31|
91668731|NCT03302078|183231838|OTHER||Geometric Mean (T/R) ratio (%)|79.08|||||TWO_SIDED|90.0|69.96|89.4|||||To get geometric mean ratio and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variance (%) = 16.0|The analysis of variance (ANOVA) model on a logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||89.40|69.96|
91668732|NCT03302078|183231839|OTHER||Geometric Mean (T/R) ratio (%)|102.44|||||TWO_SIDED|90.0|97.8|107.3|||||To get geometric mean ratio and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variance (%) = 5.9|The analysis of variance (ANOVA) model on a logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||107.30|97.80|
91668733|NCT01886872|183231840|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.26|0.58||(1-sided)|Log Rank|||Arm B (Ibrutinib) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.58|0.26|<0.001
91668734|NCT01886872|183231840|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.001|TWO_SIDED|95.0|0.25|0.59||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.59|0.25|<0.001
91668735|NCT01886872|183231840|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.49|TWO_SIDED|95.0|0.62|1.62||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm B (Ibrutinib)||1.62|0.62|0.49
91668736|NCT01957150|183231890|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.46|||||TWO_SIDED|95.0|-0.97|0.06|||||Treatment comparison for overall weeks|||0.06|-0.97|
91668737|NCT01957150|183231891|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.47|||||TWO_SIDED|95.0|-1.17|0.24|||||Overall Weeks for Male|||0.24|-1.17|
91668738|NCT01957150|183231892|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.4|||||TWO_SIDED|95.0|-1.16|0.36|||||Overall Weeks for female|||0.36|-1.16|
91668739|NCT01957150|183231893|OTHER||Percentage Change from Baseline|-1.02|||||TWO_SIDED|95.0|-1.9|-0.13|||||Overall Weeks for Male|||-0.13|-1.90|
91668740|NCT01957150|183231894|OTHER||Percentage Change from Baseline|-0.05|||||TWO_SIDED|95.0|-0.87|0.78|||||Overall Weeks for female|||0.78|-0.87|
91668741|NCT01957150|183231895|OTHER||Percentage Change from Baseline|-0.51|||||TWO_SIDED|95.0|-1.11|0.1|||||Overall week|||0.10|-1.11|
91668742|NCT01856192|183231896|SUPERIORITY|||||||0.03|||||||Log Rank|Stratified log rank test||||||0.03
91668743|NCT00098475|183231902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.|Difference in response rate between arms|0.107|||||TWO_SIDED|80.0|0.052|0.162||||||The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.||0.162|0.052|
91668744|NCT01405469|183231911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.44|STANDARD_DEVIATION|2.66|<|0.001||95.0|||||t-test, 2 sided|||this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ' s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.||||<0.001
91668745|NCT01841073|183231918|SUPERIORITY|||||||0.005||||||p-value was calculated, and is not attempting to indicate the threshold for statistical significance|ANCOVA|||||||0.005
91668746|NCT01841073|183231919|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
91668747|NCT01841073|183231920|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
91668748|NCT04404907|183231925|OTHER|ANOVA||||||0.02|||||||ANOVA|||feel more attractive||||0.02
91668749|NCT04404907|183231925|OTHER|ANOVA||||||0.001|||||||ANOVA|||tanning helps relax||||0.001
91668750|NCT04404907|183231925|OTHER|||||||0.34|||||||ANOVA|||confident with a tan||||0.34
91668751|NCT04404907|183231925|OTHER|||||||0.0004|||||||ANOVA|||Social activity||||0.0004
91668752|NCT04404907|183231925|OTHER|||||||0.66|||||||ANOVA|||Important to protect skin from the sun||||0.66
91792677|NCT01293799|183463092|OTHER|The number of recurrent peritonitis events between the two groups was tested by assuming a Poisson distribution of the number of events per follow-up time, log (follow-up time) as offset time, by using generalized linear models.|Risk Ratio (RR)|0.93||||0.54|TWO_SIDED|95.0|0.75|1.16||P-value \<0.05 was significant.|Generalized linear methods|The analysis includes all peritonitis events in the study.|In the calculation of the relative risk, data for the retraining group represents the nominator and data for the control group represents the denominator.|||1.16|0.75|0.54
91668753|NCT04404907|183231925|OTHER|||||||0.16|||||||ANOVA|||Concern about develop skin cancer||||0.16
91485140|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
91668754|NCT04404907|183231925|OTHER|||||||0.29|||||||ANOVA|||Chances of getting skin cancer are high||||0.29
91668755|NCT01653405|183231926|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
91668756|NCT01653405|183231927|SUPERIORITY|||||||0.43|||||||test of differences|||||||0.43
91668757|NCT01653405|183231928|SUPERIORITY||||||<|0.001|||||||difference in differences|||||||<0.001
91668758|NCT01653405|183231929|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
91668759|NCT01653405|183231930|SUPERIORITY|||||||0.002|||||||difference in differences|||||||0.002
91668760|NCT03174158|183231931|SUPERIORITY|||||||0.07||||||a priori p value threshold \< 0.05|Chi-squared|||||||0.07
91668761|NCT03174158|183231931|SUPERIORITY|||||||0.18|||||||Chi-squared|a priori threshold p\<0.05||||||0.18
91668762|NCT03174158|183231931|SUPERIORITY|||||||0.21||||||a priori threshold p\<0.05|Chi-squared|||||||0.21
91668763|NCT00283842|183231940|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.084
91668764|NCT00283842|183231940|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.084
91668765|NCT00283842|183231940|SUPERIORITY_OR_OTHER|||||||0.001|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.001
91668766|NCT00283842|183231940|SUPERIORITY_OR_OTHER|||||||0.027|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.027
91668767|NCT00283842|183231941|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.375
91668768|NCT00283842|183231941|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.342
91668769|NCT00283842|183231941|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.342
91668770|NCT00283842|183231941|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.375
91668771|NCT00550147|183231942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.125|STANDARD_ERROR_OF_MEAN|0.1933|<|0.05|TWO_SIDED|95.0|-1.52|-0.72|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.72|-1.52|<0.05
91714650|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.3058||95.0|-6.1|19.2|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|-6.1|0.3058
91635538|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.83|STANDARD_ERROR_OF_MEAN|9.326||0.071|TWO_SIDED|95.0|-32.368|4.709|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.709|-32.368|0.071
91714651|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.9604||95.0|-12.1|11.5|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.5|-12.1|0.9604
91714652|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.1661||95.0|-3.6|20.6|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.6|-3.6|0.1661
91635539|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.378|STANDARD_ERROR_OF_MEAN|9.464||0.361|TWO_SIDED|95.0|-22.191|15.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.435|-22.191|0.361
91635540|NCT02055976|183163599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.035|STANDARD_ERROR_OF_MEAN|9.389||0.056|TWO_SIDED|95.0|-33.698|3.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.629|-33.698|0.056
91635541|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.189|STANDARD_ERROR_OF_MEAN|5.431|<|0.001|TWO_SIDED|95.0|-86.975|-65.403|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-65.403|-86.975|<0.001
91635542|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.205|STANDARD_ERROR_OF_MEAN|5.556|<|0.001|TWO_SIDED|95.0|-106.238|-84.172|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.172|-106.238|<0.001
91635543|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-106.077|STANDARD_ERROR_OF_MEAN|5.622|<|0.001|TWO_SIDED|95.0|-117.239|-94.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-94.915|-117.239|<0.001
91635544|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.234|STANDARD_ERROR_OF_MEAN|6.622|<|0.001|TWO_SIDED|95.0|-84.39|-58.077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.077|-84.390|<0.001
91635545|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.638|STANDARD_ERROR_OF_MEAN|6.609|<|0.001|TWO_SIDED|95.0|-113.768|-87.508|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-87.508|-113.768|<0.001
91635546|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-103.386|STANDARD_ERROR_OF_MEAN|6.525|<|0.001|TWO_SIDED|95.0|-116.353|-90.42|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.420|-116.353|<0.001
91635547|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.124|STANDARD_ERROR_OF_MEAN|5.382|<|0.001|TWO_SIDED|95.0|-71.813|-50.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.435|-71.813|<0.001
91635548|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.837|STANDARD_ERROR_OF_MEAN|5.48|<|0.001|TWO_SIDED|95.0|-92.721|-70.954|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-70.954|-92.721|<0.001
91714653|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.1441||95.0|-3.1|20.9|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.9|-3.1|0.1441
91714654|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.3076||95.0|-5.6|17.5|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-5.6|0.3076
91714655|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0||||0.1209||95.0|-2.7|22.7|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||22.7|-2.7|0.1209
91714656|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2791||95.0|-5.3|18.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.0|-5.3|0.2791
91668772|NCT00550147|183231943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.2056|<|0.05||95.0|-1.75|-0.91|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.91|-1.75|<0.05
91668773|NCT00550147|183231944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|13.06|<|0.05||95.0|-74.3|-20.2|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-20.2|-74.3|<0.05
91668774|NCT00550147|183231945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|STANDARD_ERROR_OF_MEAN|1.39|<|0.05|TWO_SIDED|95.0|-7.04|-1.29|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-1.29|-7.04|<0.05
91668775|NCT00550147|183231946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|2.16|<|0.05||95.0|-17.76|-8.82|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-8.82|-17.76|<0.05
91668776|NCT01321177|183232006|SUPERIORITY|||||||0.0145|||||||Regression, Linear|||||||0.0145
91668777|NCT01540045|183232025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.013
91668778|NCT01540045|183232026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.671|TWO_SIDED||||||t-test, 2 sided|||we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.671
91714657|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2||||0.0644||95.0|-0.7|23.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.7|0.0644
91714658|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.7544||95.0|-9.5|6.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.9|-9.5|0.7544
91714659|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6||||0.5142||95.0|-10.3|5.2|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||5.2|-10.3|0.5142
91714660|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.8158||95.0|-7.4|9.4|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.4|-7.4|0.8158
91668779|NCT01540045|183232026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.694|TWO_SIDED||||||t-test, 2 sided|||we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.694
91668780|NCT01540045|183232027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||0.118
91714661|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.4599||95.0|-10.8|4.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||4.9|-10.8|0.4599
91668781|NCT01540045|183232028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607|TWO_SIDED||||||McNemar|||Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).||||0.607
91668782|NCT01540045|183232029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapy||||0.015
91668783|NCT01540045|183232029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.010
91714662|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.8636||95.0|-8.7|7.3|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.3|-8.7|0.8636
91714663|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.5281||95.0|-7.8|15.1|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-7.8|0.5281
91714664|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.6566||95.0|-8.5|13.5|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.5|-8.5|0.6566
91485141|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
91668784|NCT01540045|183232029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.004
91668785|NCT01540045|183232031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.28
91668786|NCT01540045|183232032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.889
91668787|NCT01540045|183232032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.293
91668788|NCT01540045|183232032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.009
91668789|NCT01540045|183232032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.213
91668790|NCT01540045|183232032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.595|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.595
91668791|NCT01540045|183232032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.068
91668792|NCT01540045|183232033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91714665|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.1||||0.0677||95.0|-0.8|23.0|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.8|0.0677
91714666|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.4443||95.0|-6.8|15.4|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-6.8|0.4443
91668793|NCT01540045|183232034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.240
91668794|NCT01540045|183232035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.036
91668795|NCT01540045|183232036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.312
91668796|NCT01540045|183232037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.608
91668797|NCT01540045|183232038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.035
91668798|NCT01540045|183232039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.402
91668799|NCT01540045|183232040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.109
91668800|NCT01540045|183232041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.092
91668801|NCT01540045|183232042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||McNemar|||We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)||||0.022
91668802|NCT02760433|183232047|SUPERIORITY||Risk Difference (RD)|0.19||||0.004|TWO_SIDED|97.5|0.03|0.337|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population. The OKZ ACR20 response rate for 64 mg q4w treatment group at Week 12 are expected to be at least 45%, resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.337|0.030|0.004
91668803|NCT02760433|183232047|SUPERIORITY||Risk Difference (RD)|0.203||||0.0029|TWO_SIDED|97.5|0.038|0.353|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population .The OKZ ACR20 response rate for 64 mg q2w treatment group at Week 12 is expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.353|0.038|0.0029
91668804|NCT02760433|183232048|SUPERIORITY||Risk Difference (RD)|0.176||||0.0021|TWO_SIDED|97.5|0.041|0.281|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.281|0.041|0.0021
91668805|NCT02760433|183232048|SUPERIORITY||Risk Difference (RD)|0.283|||<|0.0001|TWO_SIDED|97.5|0.139|0.396|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.396|0.139|<0.0001
91668806|NCT02760433|183232049|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.081|=|0.1814|TWO_SIDED|97.5|-0.26|0.11||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.11|-0.26|=0.1814
91668807|NCT02760433|183232049|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.083|=|0.0227|TWO_SIDED|97.5|-0.35|0.02||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.02|-0.35|=0.0227
91668808|NCT02760433|183232050|SUPERIORITY||Risk Difference (RD)|0.164|||||TWO_SIDED|97.5|0.02|0.278||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.278|0.020|
91668809|NCT02760433|183232050|SUPERIORITY||Risk Difference (RD)|0.174|||||TWO_SIDED|97.5|0.027|0.294||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.294|0.027|
91668810|NCT02760433|183232051|SUPERIORITY||Risk Difference (RD)|0.031|||||TWO_SIDED|97.5|-0.052|0.083||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.083|-0.052|
91714667|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.2543||95.0|-4.7|17.7|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.7|-4.7|0.2543
91792678|NCT01293799|183463093|OTHER|The association of factors associated with time to first peritonitis was analysed using the Cox proportional hazard regression model. Subjects were censored for various reasons to leave the study. Univariable Cox regression was used to identify factors associated with with time to first peritonitis episode. Multivariable Cox regression was performed using the backward elimination procedure, stopping when all remaining factors were significant at p \< 0.05.|Hazard Ratio (HR)|1.15||||0.0052|TWO_SIDED|95.0|1.04|1.27||Unit of measure: Age (hazard ratio per 10 years). The threshold for statistical significance was P = 0.05|Regression, Cox|The association of a age (HR per 10 years) and time to first peritonitis episode by univariable Cox regression.||The association of age and time to first peritonitis episode is analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.||1.27|1.04|0.0052
91714668|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.9416||95.0|-11.0|11.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.9|-11.0|0.9416
91668811|NCT02760433|183232051|SUPERIORITY||Risk Difference (RD)|0.065|||||TWO_SIDED|97.5|-0.023|0.134||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.134|-0.023|
91668812|NCT02151149|183232052|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9258|TWO_SIDED|95.0|0.84|1.21|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.21|0.84|0.9258
91668813|NCT02151149|183232059|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0036|TWO_SIDED|95.0|0.33|0.81|||Stratified Log Rank|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||0.81|0.33|0.0036
91668814|NCT02151149|183232060|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3537|TWO_SIDED|95.0|0.54|1.25|||Stratified log-rank test|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.25|0.54|0.3537
91668815|NCT02151149|183232061|SUPERIORITY||Risk Ratio (RR)|1.56||||0.0597|TWO_SIDED|95.0|0.971|2.511|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma)..||||2.511|0.971|0.0597
91668816|NCT02224053|183232079|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|106.66|||||TWO_SIDED|90.0|100.26|113.46|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||113.46|100.26|
91668817|NCT02224053|183232080|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|101.65|||||TWO_SIDED|90.0|94.65|109.16|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||109.16|94.65|
91668818|NCT02224053|183232089|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.79|||||TWO_SIDED|90.0|88.77|101.21||||||AZ5104||101.21|88.77|
91668819|NCT02224053|183232089|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geomteric mean ratio|89.7|||||TWO_SIDED|90.0|83.89|95.91||||||AZ7550||95.91|83.89|
91668820|NCT02224053|183232090|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|102.32|||||TWO_SIDED|90.0|96.87|108.07|||||AZD9291+omeprazole / AZD9291 alone|AZ5104||108.07|96.87|
91668821|NCT02224053|183232090|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.03|||||TWO_SIDED|90.0|89.92|98.33||||||AZ7550||98.33|89.92|
91668822|NCT01898598|183232103|SUPERIORITY_OR_OTHER||Difference in Clinical Response Rates|-21.8|||||TWO_SIDED|95.0|-71.6|32.1||||||The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.||32.1|-71.6|
91668823|NCT01898598|183232104|SUPERIORITY_OR_OTHER||Percentage Difference|-40.0|||||TWO_SIDED|95.0|-85.3|14.2||||||||14.2|-85.3|
91668824|NCT01499160|183232121|OTHER|Not done due to low accrual||||||||||||Not done due to low accrual|Not done due to low accrual|Not done due to low accrual||Not done due to low accrual|Not done due to low accrual|||
91668825|NCT02033317|183232136|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||paired t-test|||||||= 0.14
91668826|NCT02033317|183232137|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.02|TWO_SIDED||||||paired t-test|||||||= 0.02
91668827|NCT02911935|183232150|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.08|TWO_SIDED|95.0|0.95|2.34||unadjusted P-value. The threshold for statistical significance was p = 0.05|Log Rank|||The primary analysis tested the statistical null hypothesis of equal recurrent wheeze rates between the azithromycin and placebo groups.||2.34|0.95|0.08
91668828|NCT02911935|183232150|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||p-value is adjusted for race, parental history of asthma, ever exposed to smoke and ever exposed to pets. The threshold for statistical significance was p = 0.05|Regression, Cox|||||2.29|0.92|0.11
91668829|NCT02911935|183232151|SUPERIORITY||Hazard Ratio (HR)|1.95||||0.12|TWO_SIDED|95.0|0.83|4.61||Unadjusted. The threshold for statistical significance was p = 0.05|Log Rank|||||4.61|0.83|0.12
91668830|NCT02911935|183232152|SUPERIORITY||Rate Ratio|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.62|0.86|0.31
91668831|NCT02911935|183232153|SUPERIORITY||Rate Ratio|1.22||||0.57|TWO_SIDED|95.0|0.6|2.48||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.48|0.6|0.57
91668832|NCT02911935|183232154|SUPERIORITY||Rate Ratio|1.34||||0.38|TWO_SIDED|95.0|0.7|2.57||unadjusted P-value. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.57|0.70|0.38
91668833|NCT02911935|183232155|SUPERIORITY||Rate Ratio|0.92||||0.56|TWO_SIDED|95.0|0.7|1.22||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.22|0.7|0.56
91668834|NCT04979858|183232184|OTHER|The statistical analysis involved the use of a single-factor ANOVA test to assess the importance of the various factors associated with the design of the Focal Mask (the Treatment) that would impact its performance in reducing the spread of COVID-19, which is caused by the SARS-CoV-2 virus. The Bonferroni t-test was conducted post hoc to assess the statistical significance of the various factors.|||||<|0.01|||||||ANOVA|||||||<0.01
91668835|NCT02063217|183232213|SUPERIORITY|Mixed linear models|Mean Difference (Net)|17.0||||0.07|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean (standard error), units = %. 17(7.2) increase in overnight amyloid-beta 40 concentrations over waking baseline between the sleep deprivation group and controls.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||0.07
91668836|NCT02063217|183232213|SUPERIORITY|Mixed linear models|Mean Difference (Net)|7.0||||1|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean= 7%, standard error = 7.6%. 7% increase in overnight amyloid beta 40 concentrations over the waking baseline between the sleep induction group and control group.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||1.0
91668837|NCT04291508|183232214|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.5|||t-test, 2 sided|||||2.5|-1.6|0.65
91668838|NCT04291508|183232214|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.464|TWO_SIDED|95.0|-3.5|7.6|||t-test, 2 sided|||||7.6|-3.5|0.464
91668839|NCT04291508|183232215|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-12.0|3.3|||Chi-squared|||||3.3|-12.0|0.26
91668840|NCT04291508|183232215|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
91668841|NCT04291508|183232216|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.35|TWO_SIDED|95.0|-1.0|2.9|||t-test, 2 sided|||||2.9|-1.0|0.35
91668842|NCT04291508|183232216|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.45|TWO_SIDED|95.0|-3.4|7.6|||t-test, 2 sided|||||7.6|-3.4|0.45
91668843|NCT04291508|183232217|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.9|1.5|||t-test, 2 sided|||||1.5|-1.9|0.83
91668844|NCT04291508|183232217|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.1|TWO_SIDED|95.0|-0.8|8.9|||t-test, 2 sided|||||8.9|-0.8|0.10
91668845|NCT04291508|183232218|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.55|TWO_SIDED|95.0|-1.2|2.4|||t-test, 2 sided|||||2.4|-1.2|0.55
91668846|NCT04291508|183232218|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.18|TWO_SIDED|95.0|-1.6|8.7|||t-test, 2 sided|||||8.7|-1.6|0.18
91668847|NCT04291508|183232219|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.21|TWO_SIDED|95.0|-0.8|3.6|||t-test, 2 sided|||||3.6|-0.8|0.21
91668848|NCT04291508|183232219|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.4|TWO_SIDED|95.0|-3.4|8.5|||t-test, 2 sided|||||8.5|-3.4|0.40
91668849|NCT04291508|183232220|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.23|TWO_SIDED|95.0|-0.8|3.4|||t-test, 2 sided|||||3.4|-0.8|0.23
91668850|NCT04291508|183232220|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.22|TWO_SIDED|95.0|-2.2|9.4|||t-test, 2 sided|||||9.4|-2.2|0.22
91668851|NCT04291508|183232221|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.58|TWO_SIDED|95.0|-1.6|2.8|||t-test, 2 sided|||||2.8|-1.6|0.58
91635549|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-89.683|STANDARD_ERROR_OF_MEAN|5.567|<|0.001|TWO_SIDED|95.0|-100.74|-78.627|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-78.627|-100.740|<0.001
91635550|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.747|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-88.902|-64.593|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.593|-88.902|<0.001
91635551|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.666|STANDARD_ERROR_OF_MEAN|6.098|<|0.001|TWO_SIDED|95.0|-112.781|-88.551|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-88.551|-112.781|<0.001
91635552|NCT02055976|183163601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-109.49|STANDARD_ERROR_OF_MEAN|6.054|<|0.001|TWO_SIDED|95.0|-121.519|-97.462|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-97.462|-121.519|<0.001
91635553|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.772|STANDARD_ERROR_OF_MEAN|3.473|<|0.001|TWO_SIDED|95.0|-53.671|-39.874|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.874|-53.671|<0.001
91635554|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.554|<|0.001|TWO_SIDED|95.0|-66.257|-52.143|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.143|-66.257|<0.001
91635555|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.868|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-74.007|-59.73|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.730|-74.007|<0.001
91635556|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.051|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-47.195|-32.908|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.908|-47.195|<0.001
91635557|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.009|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-63.135|-48.882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.882|-63.135|<0.001
91635558|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.576|STANDARD_ERROR_OF_MEAN|3.544|<|0.001|TWO_SIDED|95.0|-64.618|-50.533|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.533|-64.618|<0.001
91668852|NCT04291508|183232221|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.13|TWO_SIDED|95.0|-1.4|10.5|||t-test, 2 sided|||||10.5|-1.4|0.13
91635559|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.991|STANDARD_ERROR_OF_MEAN|3.389|<|0.001|TWO_SIDED|95.0|-44.721|-31.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.260|-44.721|<0.001
91635560|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.856|STANDARD_ERROR_OF_MEAN|3.451|<|0.001|TWO_SIDED|95.0|-57.709|-44.002|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.002|-57.709|<0.001
91668853|NCT04291508|183232222|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-11.8|3.2|||Chi-squared|||||3.2|-11.8|0.26
91668854|NCT04291508|183232222|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
91668855|NCT04291508|183232223|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.6|2.2|||t-test, 2 sided|||||2.2|-1.6|0.76
91668856|NCT04291508|183232223|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.78|TWO_SIDED|95.0|-4.9|6.5|||t-test, 2 sided|||||6.5|-4.9|0.78
91668857|NCT04291508|183232224|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.3|1.9|||t-test, 2 sided|||||1.9|-2.3|0.84
91668858|NCT04291508|183232224|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.1|TWO_SIDED|95.0|-0.9|10.0|||t-test, 2 sided|||||10.0|-0.9|0.10
91668859|NCT04291508|183232225|SUPERIORITY||Risk Difference (RD)|-1.3||||0.79|TWO_SIDED|95.0|-10.9|8.3|||Chi-squared|||||8.3|-10.9|0.79
91668860|NCT04291508|183232225|SUPERIORITY||Risk Difference (RD)|4.9||||1|TWO_SIDED|95.0|-17.5|27.3|||Fisher Exact|||||27.3|-17.5|1.00
91668861|NCT04291508|183232226|SUPERIORITY||Risk Difference (RD)|1.7||||0.53|TWO_SIDED|95.0|-3.7|7.2|||Chi-squared|||||7.2|-3.7|0.53
91714669|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5824||95.0|-14.1|7.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.9|-14.1|0.5824
91714670|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4||||0.5668||95.0|-15.3|8.4|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.4|-15.3|0.5668
91714671|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.7769||95.0|-9.6|12.8|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-9.6|0.7769
91714672|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.1753||95.0|-3.5|19.1|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.1|-3.5|0.1753
91714673|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7||||0.1508||95.0|-3.2|20.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.7|-3.2|0.1508
91714674|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.9||||0.0916||95.0|-1.6|21.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.4|-1.6|0.0916
91714675|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.6222||95.0|-9.2|15.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-9.2|0.6222
91714676|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.085||95.0|-1.4|21.8|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.8|-1.4|0.0850
91714677|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8||||0.0154||95.0|2.9|26.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||26.7|2.9|0.0154
91714678|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7201||95.0|-11.9|8.2|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.2|-11.9|0.7201
91714679|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.8875||95.0|-9.1|10.5|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.5|-9.1|0.8875
91714680|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.3735||95.0|-5.7|15.1|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-5.7|0.3735
91714681|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8621||95.0|-8.9|10.6|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.6|-8.9|0.8621
91714682|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.9||||0.1203||95.0|-2.1|17.8|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.8|-2.1|0.1203
91527843|NCT06173570|182930690|SUPERIORITY||Mean Difference (Net)|-39.87|||<|0.001|TWO_SIDED|95.0|-45.92|-33.83|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 values handled by the MMRM under MAR.||-33.83|-45.92|< 0.001
91668862|NCT04291508|183232226|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-17.0|13.0|||Fisher Exact|||||13.0|-17.0|1.00
91668863|NCT04291508|183232227|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.9|0.6|||t-test, 2 sided|||||0.6|-0.9|0.70
91668864|NCT04291508|183232227|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-2.7|2.5|||t-test, 2 sided|||||2.5|-2.7|0.96
91668865|NCT04291508|183232228|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-2.3|7.3|||Fisher Exact|||||7.3|-2.3|1.00
91668866|NCT04291508|183232229|SUPERIORITY||Risk Difference (RD)|-4.4||||0.31|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||||4.2|-13.1|0.31
91668867|NCT04291508|183232229|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
91668868|NCT04291508|183232230|SUPERIORITY||Risk Difference (RD)|-0.5||||0.9|TWO_SIDED|95.0|-8.5|7.5|||Chi-squared|||||7.5|-8.5|0.90
91668869|NCT04291508|183232230|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
91635561|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.354|STANDARD_ERROR_OF_MEAN|3.505|<|0.001|TWO_SIDED|95.0|-63.315|-49.393|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.393|-63.315|<0.001
91635562|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.172|STANDARD_ERROR_OF_MEAN|3.647|<|0.001|TWO_SIDED|95.0|-50.417|-35.926|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.926|-50.417|<0.001
91668870|NCT04291508|183232231|SUPERIORITY||Risk Difference (RD)|-7.3||||0.003|TWO_SIDED|95.0|-12.2|-2.4|||Chi-squared|||||-2.4|-12.2|0.003
91668871|NCT04291508|183232231|SUPERIORITY||Risk Difference (RD)|6.7||||0.52|TWO_SIDED|95.0|-2.3|15.6|||Fisher Exact|||||15.6|-2.3|0.52
91668872|NCT04291508|183232232|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||||0.2|-0.2|0.68
91668873|NCT04291508|183232232|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Fisher Exact|||||0.4|-0.7|0.62
91668874|NCT04291508|183232233|SUPERIORITY||Risk Difference (RD)|0.5||||0.9|TWO_SIDED|95.0|-7.8|8.8|||Chi-squared|||||8.8|-7.8|0.90
91668875|NCT04291508|183232233|SUPERIORITY||Risk Difference (RD)|-15.6||||0.2|TWO_SIDED|95.0|-40.1|8.9|||Chi-squared|||||8.9|-40.1|0.2
91668876|NCT04291508|183232234|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.1|1.3|||t-test, 2 sided|||||1.3|-1.1|0.88
91668877|NCT04291508|183232234|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.1|TWO_SIDED|95.0|-0.6|6.6|||t-test, 2 sided|||||6.6|-0.6|0.10
91668878|NCT03566238|183232235|SUPERIORITY||percentage difference|0.435||||0.0015|TWO_SIDED|95.0|0.2195|0.6551|||Cochran-Mantel-Haenszel|||"Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The 1-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~1-sided adjusted p-value was reported."||0.6551|0.2195|0.0015
91668879|NCT03566238|183232235|SUPERIORITY||percentage difference|0.211||||0.0174|TWO_SIDED|95.0|0.021|0.4557|||Cochran-Mantel-Haenszel|||"Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The 1-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~1-sided adjusted p-value was reported."||0.4557|0.021|0.0174
91668880|NCT03566238|183232236|SUPERIORITY|"Analysis of Covariance (ANCOVA) model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The 1-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~1-sided adjusted p-value was reported."|Least Square (LS) mean difference|28.23|STANDARD_ERROR_OF_MEAN|9.182||0.0019|TWO_SIDED|95.0|9.83|46.64|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores).||46.64|9.83|0.0019
91668881|NCT03566238|183232236|SUPERIORITY|"An ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The 1-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~1-sided adjusted p-value was reported."|LS mean difference|21.71|STANDARD_ERROR_OF_MEAN|9.892||0.0163|TWO_SIDED|95.0|1.87|41.54|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores).||41.54|1.87|0.0163
91668882|NCT00593827|183232258|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|||||||0.03
91668883|NCT00593827|183232259|SUPERIORITY_OR_OTHER|||||||0.05|||||||Log Rank|||||||0.05
91668884|NCT00593827|183232262|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
91668885|NCT02627001|183232277|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Ranks|||||||<0.001
91668886|NCT01049581|183232278|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA was used and the result reveled (F1, 17 = 7.565, η2= 0.308, p = 0.007)||||||0.007|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy group||||0.007
91668887|NCT01049581|183232279|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA : p value 0.393|Mean Difference (Net)|1.762||||0.393|ONE_SIDED|95.0||||"Effect Size η2~0.023"|ANCOVA|F1,17= 0.380||We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADL||||0.393
91668888|NCT01049581|183232280|SUPERIORITY_OR_OTHER|||||||0.332|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy group||||0.332
91668889|NCT04592419|183232281|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.0004|TWO_SIDED|95.02|-3.11|0.3|||Mixed Models Analysis|MMRM model with treatment, visit, treatment × visit interaction, baseline BCVA, disease duration, and geographical location as covariates.||||0.30|-3.11|.0004
91668890|NCT04592419|183232282|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.9||0.0243|TWO_SIDED|95.02|-4.24|-0.71|||Mixed Models Analysis|MMRM model treatment, visit, treatment × visit interaction, RVO subtype, baseline BCVA, disease duration, and geographical location as covariates.||||-0.71|-4.24|.0243
91668891|NCT04241133|183232301|OTHER|The experimental and control groups were not compared due to the inability to collect post data with the control group because of stay at home orders during the COVID-19 pandemic.|||||<|0.05||||||The reported P-value was calculated.|t-test, 2 sided|The a priori threshold for statistical significance was P\<0.05.||The experimental group was tested for significant difference in Healthy Eating Index 2015 (HEI-2015) scores at baseline and 12 weeks. SAS macros provided by the National Cancer Institute were used to compute HEI-2015 scores for each dietary recall at pre- (baseline) and post-intervention (12 weeks) using the Simple HEI Scoring Algorithm.||||<0.05
91668892|NCT01503333|183232302|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at post-intervention. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at post-intervention.|parameter estimate|-0.08||||0.207|TWO_SIDED|95.0|-0.21|0.05|||Mixed Models Analysis|||Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).||0.05|-0.21|.207
91668893|NCT01503333|183232303|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on CV fitness according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline CV fitness, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|0.03|0.36|||Mixed Models Analysis|||Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.||0.36|0.03|.018
91668894|NCT01503333|183232304|OTHER|Linear mixed models were used to analyze intervention effect on BMI-z according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models for BMI-z included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline BMI-z, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.191|TWO_SIDED|95.0|-0.05|0.01|||Mixed Models Analysis|||Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.||0.01|-0.05|.191
91668895|NCT01503333|183232305|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on % body fat according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline % body fat, age, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and year cohort.|parameter estimate|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|-0.64|-0.1|||Mixed Models Analysis|||Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.||-0.10|-0.64|.007
91668896|NCT01503333|183232306|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at 9-month follow up. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at follow up.|parameter estimate|-0.09||||0.118|TWO_SIDED|95.0|-0.21|0.02|||Mixed Models Analysis|||||0.02|-0.21|.118
91668897|NCT01503333|183232307|OTHER||parameter estimate|-0.97|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p\>.05.26.||||
91668898|NCT01503333|183232308|OTHER||parameter estimate|2.9|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
91668899|NCT01503333|183232309|OTHER||parameter estimate|0.47|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
91668900|NCT01503333|183232310|OTHER||parameter estimate|30.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
91668901|NCT01503333|183232311|OTHER||parameter estimate|24.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
91714683|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.4966||95.0|-5.4|11.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.0|-5.4|0.4966
91714684|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2||||0.5776||95.0|-5.6|10.1|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.1|-5.6|0.5776
91485142|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
91668902|NCT01503333|183232312|OTHER||parameter estimate|3.19|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
91668903|NCT04254198|183232315|SUPERIORITY||Slope|0.231|STANDARD_ERROR_OF_MEAN|0.116||0.0473|TWO_SIDED|98.3|-0.0474|0.509||To adjust for multiplicity due to three primary outcomes, the p-value should be compared to a Bonferroni-corrected type-I error level of 0.05/3 = 0.017.|Mixed Models Analysis|Model is adjusted for cohort, site, marital status, and overall health status.|The beta coefficient (0.231) is for the treatment x time interaction effect on log-transformed CES-D scores. Delta method used for calculating confidence intervals for the Least Squares (LS) Mean changes over time per arm with cov=compound symmetry.|||0.509|-0.0474|0.0473
91668904|NCT04254198|183232316|SUPERIORITY||Slope|0.383|STANDARD_ERROR_OF_MEAN|0.14||0.0067|TWO_SIDED|98.3|0.0464|0.72||To adjust for multiplicity due to three primary outcomes, the p-value should be compared to a Bonferroni-corrected type-I error level of 0.05/3 = 0.017.|Mixed Models Analysis|Model is adjusted for cohort, site, overall health status and the interaction between cohort and site.|The beta coefficient (0.383) is for the treatment x time interaction effect on log-transformed CD-RISC scores. Delta method used for calculating confidence intervals for the LS Mean changes over time per arm with cov=compound symmetry.|||0.720|0.0464|0.0067
91668905|NCT04254198|183232317|SUPERIORITY||Slope|-0.747|STANDARD_ERROR_OF_MEAN|0.194||0.0002|TWO_SIDED|98.3|-1.215|-0.28||To adjust for multiplicity due to three primary outcomes, the p-value should be compared to a Bonferroni-corrected type-I error level of 0.05/3 = 0.017.|Mixed Models Analysis|Generalized linear mixed model with beta distribution, adjusted for cohort, site, overall health status and interaction between arm and cohort.|The beta coefficient (-0.747) is for the treatment x time interaction effect on MOS-SS scores on a logit scale. The CIs for the LS Mean changes over time per arm were estimated via the delta method and are reported on the original MOS-SS scale.|||-0.280|-1.215|0.0002
91668906|NCT04254198|183232318|SUPERIORITY||Slope|-0.913|STANDARD_ERROR_OF_MEAN|1.21||0.451|TWO_SIDED|95.0|-3.82|2.0||P-value not adjusted for multiple comparisons|Mixed Models Analysis|Model is adjusted for cohort and site.|The beta coefficient (-0.913) is for the treatment x time interaction effect on non-transformed PSS scores.|||2.00|-3.82|0.4510
91668907|NCT02152982|183232319|SUPERIORITY|||||||0.1673|||||||Log Rank|||||||0.1673
91668908|NCT02152982|183232320|OTHER|Interaction test|Cox Proportional Hazard|0.89||||0.6659|TWO_SIDED|95.0|0.53|1.5|||Type 3 likelihood-ratio p-value|||||1.50|0.53|0.6659
91668909|NCT02152982|183232321|SUPERIORITY||Stratified Cox Proportional Hazard|1.05||||0.3164|TWO_SIDED|95.0|0.86|1.29|||Stratified Log Rank|||||1.29|0.86|0.3164
91668910|NCT02152982|183232322|SUPERIORITY|||||||0.7018|||||||Chi-squared|||||||0.7018
91635563|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.698|STANDARD_ERROR_OF_MEAN|3.633|<|0.001|TWO_SIDED|95.0|-63.916|-49.48|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.480|-63.916|<0.001
91792679|NCT01293799|183463093|OTHER||Hazard Ratio (HR)|1.16||||0.0041|TWO_SIDED|95.0|1.05|1.29||Unit of measure: Age (hazard ratio per 10 years) and time to first peritonitis episode by multivariable Cox regression. The threshold for statistical significance was P = 005.|Regression, Cox|Multivariable Cox regression||Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode (see statistical analysis 1). Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.||1.29|1.05|0.0041
91714685|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.3955||95.0|-4.9|12.3|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.3|-4.9|0.3955
91635564|NCT02055976|183163602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.305|STANDARD_ERROR_OF_MEAN|3.609|<|0.001|TWO_SIDED|95.0|-68.477|-54.134|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.134|-68.477|<0.001
91668911|NCT02152982|183232323|SUPERIORITY|||||||0.0003|||||||Chi-squared|||||||0.0003
91485143|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.011|TWO_SIDED|95.0|-0.28|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.28|0.011
91668912|NCT04968925|183232331|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|4.24|||||TWO_SIDED|95.0|0.8|22.54|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||22.54|0.80|
91668913|NCT04968925|183232332|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|3.44|||||TWO_SIDED|95.0|1.16|10.16|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||10.16|1.16|
91668914|NCT04968925|183232333|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.05|6.76|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||6.76|1.05|
91635565|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.69928|STANDARD_ERROR_OF_MEAN|0.13216|<|0.001|TWO_SIDED|95.0|-1.96175|-1.43682|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.43682|-1.96175|<0.001
91525948|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.61|-0.31|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.31|-0.61|<0.0001
91635566|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.07922|STANDARD_ERROR_OF_MEAN|0.13446|<|0.001|TWO_SIDED|95.0|-2.34622|-1.81223|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.81223|-2.34622|<0.001
91635567|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.23886|STANDARD_ERROR_OF_MEAN|0.13553|<|0.001|TWO_SIDED|95.0|-2.50795|-1.96978|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.96978|-2.50795|<0.001
91635568|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.43281|STANDARD_ERROR_OF_MEAN|0.16311|<|0.001|TWO_SIDED|95.0|-1.75689|-1.10872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.10872|-1.75689|<0.001
91635569|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01501|STANDARD_ERROR_OF_MEAN|0.16217|<|0.001|TWO_SIDED|95.0|-2.33718|-1.69283|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.69283|-2.33718|<0.001
91635570|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.11359|STANDARD_ERROR_OF_MEAN|0.16038|<|0.001|TWO_SIDED|95.0|-2.4323|-1.79489|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.79489|-2.43230|<0.001
91635571|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35298|STANDARD_ERROR_OF_MEAN|0.13609|<|0.001|TWO_SIDED|95.0|-1.62324|-1.08271|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.08271|-1.62324|<0.001
91635572|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.79615|STANDARD_ERROR_OF_MEAN|0.1379|<|0.001|TWO_SIDED|95.0|-2.07001|-1.52229|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.52229|-2.07001|<0.001
91635573|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.86921|STANDARD_ERROR_OF_MEAN|0.13927|<|0.001|TWO_SIDED|95.0|-2.14575|-1.59266|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.59266|-2.14575|<0.001
91668915|NCT04968925|183232334|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.76|||||TWO_SIDED|98.33|1.09|2.83|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.83|1.09|
91635574|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.57311|STANDARD_ERROR_OF_MEAN|0.14333|<|0.001|TWO_SIDED|95.0|-1.85788|-1.28834|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.28834|-1.85788|<0.001
91635575|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.00256|STANDARD_ERROR_OF_MEAN|0.14228|<|0.001|TWO_SIDED|95.0|-2.28521|-1.7199|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.71990|-2.28521|<0.001
91635576|NCT02055976|183163604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.20298|STANDARD_ERROR_OF_MEAN|0.14142|<|0.001|TWO_SIDED|95.0|-2.48399|-1.92197|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.92197|-2.48399|<0.001
91714686|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.7994||95.0|-6.9|9.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.0|-6.9|0.7994
91635577|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.92915|STANDARD_ERROR_OF_MEAN|2.83037|<|0.001|TWO_SIDED|95.0|-47.55052|-36.30778|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.30778|-47.55052|<0.001
91635578|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.08604|STANDARD_ERROR_OF_MEAN|2.88356|<|0.001|TWO_SIDED|95.0|-56.81235|-45.35973|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.35973|-56.81235|<0.001
91635579|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.516|STANDARD_ERROR_OF_MEAN|2.91014|<|0.001|TWO_SIDED|95.0|-61.29424|-49.73777|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.73777|-61.29424|<0.001
91635580|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.30375|STANDARD_ERROR_OF_MEAN|3.07498|<|0.001|TWO_SIDED|95.0|-39.41376|-27.19373|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.19373|-39.41376|<0.001
91635581|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.8521|STANDARD_ERROR_OF_MEAN|3.05746|<|0.001|TWO_SIDED|95.0|-53.92668|-41.77751|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.77751|-53.92668|<0.001
91635582|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.65686|STANDARD_ERROR_OF_MEAN|3.02097|<|0.001|TWO_SIDED|95.0|-54.6606|-42.65313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.65313|-54.66060|<0.001
91635583|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.5292|STANDARD_ERROR_OF_MEAN|2.96599|<|0.001|TWO_SIDED|95.0|-39.42015|-27.63826|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.63826|-39.42015|<0.001
91635584|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.8568|STANDARD_ERROR_OF_MEAN|3.00531|<|0.001|TWO_SIDED|95.0|-49.82617|-37.88744|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-37.88744|-49.82617|<0.001
91635585|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.36865|STANDARD_ERROR_OF_MEAN|3.03981|<|0.001|TWO_SIDED|95.0|-52.40589|-40.33142|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.33142|-52.40589|<0.001
91635586|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.06019|STANDARD_ERROR_OF_MEAN|3.1361|<|0.001|TWO_SIDED|95.0|-44.29176|-31.82863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.82863|-44.29176|<0.001
91635587|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.57807|STANDARD_ERROR_OF_MEAN|3.1135|<|0.001|TWO_SIDED|95.0|-54.76397|-42.39217|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.39217|-54.76397|<0.001
91714687|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2||||0.2073||95.0|-2.9|13.2|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.2|-2.9|0.2073
91714688|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.5148||95.0|-6.4|12.8|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-6.4|0.5148
91635588|NCT02055976|183163605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.87214|STANDARD_ERROR_OF_MEAN|3.09363|<|0.001|TWO_SIDED|95.0|-58.01968|-45.7246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.72460|-58.01968|<0.001
91635589|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33157|STANDARD_ERROR_OF_MEAN|0.02639|<|0.001|TWO_SIDED|95.0|-0.38399|-0.27916|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.27916|-0.38399|<0.001
91635590|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44402|STANDARD_ERROR_OF_MEAN|0.02682|<|0.001|TWO_SIDED|95.0|-0.49727|-0.39077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39077|-0.49727|<0.001
91635591|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.48314|STANDARD_ERROR_OF_MEAN|0.02698|<|0.001|TWO_SIDED|95.0|-0.53671|-0.42956|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.42956|-0.53671|<0.001
91635592|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.30542|STANDARD_ERROR_OF_MEAN|0.0323|<|0.001|TWO_SIDED|95.0|-0.3696|-0.24124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.24124|-0.36960|<0.001
91635593|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44143|STANDARD_ERROR_OF_MEAN|0.03183|<|0.001|TWO_SIDED|95.0|-0.50466|-0.37821|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.37821|-0.50466|<0.001
91635594|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46235|STANDARD_ERROR_OF_MEAN|0.03148|<|0.001|TWO_SIDED|95.0|-0.52491|-0.3998|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39980|-0.52491|<0.001
91635595|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26949|STANDARD_ERROR_OF_MEAN|0.02615|<|0.001|TWO_SIDED|95.0|-0.32142|-0.21755|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.21755|-0.32142|<0.001
91635596|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.37493|STANDARD_ERROR_OF_MEAN|0.02649|<|0.001|TWO_SIDED|95.0|-0.42754|-0.32231|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.32231|-0.42754|<0.001
91635597|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41199|STANDARD_ERROR_OF_MEAN|0.02676|<|0.001|TWO_SIDED|95.0|-0.46512|-0.35886|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.35886|-0.46512|<0.001
91635598|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31806|STANDARD_ERROR_OF_MEAN|0.02979|<|0.001|TWO_SIDED|95.0|-0.37723|-0.25888|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.25888|-0.37723|<0.001
91668916|NCT04968925|183232335|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.52|||||TWO_SIDED|96.66|1.02|2.28|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.28|1.02|
91635599|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.42583|STANDARD_ERROR_OF_MEAN|0.02932|<|0.001|TWO_SIDED|95.0|-0.48409|-0.36758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.36758|-0.48409|<0.001
91714689|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.5255||95.0|-6.3|12.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.2|-6.3|0.5255
91635600|NCT02055976|183163607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45501|STANDARD_ERROR_OF_MEAN|0.02912|<|0.001|TWO_SIDED|95.0|-0.51287|-0.39715|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39715|-0.51287|<0.001
91635601|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.42411|STANDARD_ERROR_OF_MEAN|3.72907|<|0.001|TWO_SIDED|95.0|-56.83019|-42.01803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.01803|-56.83019|<0.001
91668917|NCT04968925|183232336|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.77|2.03|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.03|0.77|
91635602|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.63383|STANDARD_ERROR_OF_MEAN|3.7905|<|0.001|TWO_SIDED|95.0|-74.16086|-59.10681|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.10681|-74.16086|<0.001
91635603|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.72901|STANDARD_ERROR_OF_MEAN|3.81541|<|0.001|TWO_SIDED|95.0|-79.30431|-64.15371|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.15371|-79.30431|<0.001
91635604|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.56596|STANDARD_ERROR_OF_MEAN|3.92236|<|0.001|TWO_SIDED|95.0|-51.35899|-35.77293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.77293|-51.35899|<0.001
91635605|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.34926|STANDARD_ERROR_OF_MEAN|3.86432|<|0.001|TWO_SIDED|95.0|-70.02607|-54.67245|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.67245|-70.02607|<0.001
91635606|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-65.06617|STANDARD_ERROR_OF_MEAN|3.82052|<|0.001|TWO_SIDED|95.0|-72.65818|-57.47415|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.47415|-72.65818|<0.001
91635607|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.52435|STANDARD_ERROR_OF_MEAN|3.66973|<|0.001|TWO_SIDED|95.0|-47.81299|-33.23571|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.23571|-47.81299|<0.001
91635608|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.14495|STANDARD_ERROR_OF_MEAN|3.71641|<|0.001|TWO_SIDED|95.0|-63.52668|-48.76322|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.76322|-63.52668|<0.001
91635609|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.5637|STANDARD_ERROR_OF_MEAN|3.7569|<|0.001|TWO_SIDED|95.0|-69.0251|-54.1023|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.10230|-69.02510|<0.001
91668918|NCT00835796|183232349|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|94.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|94.2|
91668919|NCT00835796|183232350|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.7||||||90.0|94.0|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|94.0|
91792680|NCT01293799|183463094|OTHER|The association of factors associated with time to first peritonitis was analysed using the Cox proportional hazard regression model. Subjects were censored for various reasons to leave the study. Univariable Cox regression was used to identify factors associated with with time to first peritonitis episode. Multivariable Cox regression was performed using the backward elimination procedure, stopping when all remaining factors were significant at p \< 0.05.|Hazard Ratio (HR)|1.25||||0.13|TWO_SIDED|95.0|0.93|1.66||Unit of measure: Gender (male vs. female). P \<0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression was used.||The association of gender (male vs. female) and time to first peritonitis episode was analysed by univariable Cox regression.||1.66|0.93|0.13
91635610|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.34109|STANDARD_ERROR_OF_MEAN|4.16385|<|0.001|TWO_SIDED|95.0|-54.61427|-38.06792|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.06792|-54.61427|<0.001
91635611|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.3789|STANDARD_ERROR_OF_MEAN|4.09957|<|0.001|TWO_SIDED|95.0|-69.52338|-53.23443|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.23443|-69.52338|<0.001
91668920|NCT00835796|183232351|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.8||||||90.0|94.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.5|
91714690|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4||||0.3793||95.0|-5.5|14.4|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.4|-5.5|0.3793
91635612|NCT02055976|183163608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.67274|STANDARD_ERROR_OF_MEAN|4.06866|<|0.001|TWO_SIDED|95.0|-72.75728|-56.5882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.58820|-72.75728|<0.001
91635613|NCT02504424|183163622|OTHER||percent of breasts successfully exchange|100.0|||||ONE_SIDED|||||||||Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts - 6 breasts). Failed exchange = 4 breasts (non-device related) \& Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).||||
91635614|NCT02504424|183163622|OTHER||% breasts successfully exchanged|100.0|||||ONE_SIDED|||||||||Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.||||
91635615|NCT02504424|183163623|OTHER||% breasts successfully exchanged|95.2|||||ONE_SIDED|||||||||Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.||||
91635616|NCT04259749|183163628|OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.58|3.4|||||Adjusted for age, education, lifetime use of tobacco products.|||3.40|0.58|
91635617|NCT04259749|183163628|OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|0.92|5.63|||||Adjusted for age, education, and lifetime use of tobacco products|||5.63|0.92|
91635618|NCT04259749|183163629|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.61|4.07|||||Adjusted for age, education, and lifetime use of tobacco products|||4.07|0.61|
91635619|NCT04259749|183163629|OTHER||Odds Ratio (OR)|3.45|||||TWO_SIDED|95.0|1.32|9.02|||||Adjusted for age, education, and lifetime use of tobacco products|||9.02|1.32|
91635620|NCT04259749|183163630|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.59|3.68|||||Adjusted for age, education, and lifetime use of tobacco|||3.68|.59|
91668921|NCT00876265|183232361|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% CI or the difference between LS mean (Belotero) and LS mean (Zyplast) lies entirely above -Δ, noninferiority of Belotero will be concluded (first step). If, in addition, the CI lies entirely above 0, superiority of Belotero over Zyplast will be concluded (second step).|Adjusted (LS) mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.139||0.733|TWO_SIDED|95.0|-0.228|0.323||Treatment term and all significant (p ≤ 0.10) covariate and covariate by treatment interactions will be retained in the final ANCOVA model. From the final ANCOVA model, adjusted (LS) means for Belotero and Zyplast was computed.|ANCOVA|||"The null, H0, and the alternative hypothesis, H1, are as follows:~H0(1): adjusted mean(dadj\[i\]) ≤ -Δ versus H1(1): adjusted mean(dadj\[i\]) \> -Δ H0(2): adjusted mean(dadj\[i\]) ≤ 0 versus H1(2): adjusted mean(dadj\[i\]) \> 0 The sample size calculation was based on the following assumptions: Type I error α = 0.025 (one sided); Power = 90%; Non-inferiority margin Δ = 0.25; Estimated common standard deviation (SD) = 0.75. Under these assumptions, a total of 100 evaluable subjects were needed."||0.323|-0.228|0.733
91635621|NCT04259749|183163630|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.05|6.42|||||Adjusted for age, education, and lifetime use of tobacco products.|||6.42|1.05|
91635622|NCT04259749|183163631|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.47|2.49|||||Adjusted for age, education, and lifetime use of tobacco|||2.49|.47|
91635623|NCT04259749|183163631|OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.62|3.31|||||Adjusted for age, education, and lifetime use of tobacco products|||3.31|.62|
91635624|NCT04259749|183163632|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime use of tobacco products|||4.14|.72|
91635625|NCT04259749|183163632|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime use of tobacco products.|||4.95|.83|
91635626|NCT04259749|183163633|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.4|3.18|||||Adjusted for age, education, and lifetime tobacco use|||3.18|.40|
91635627|NCT04259749|183163633|OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|95.0|0.73|5.71|||||Adjusted for age, education, and lifetime tobacco use|||5.71|.73|
91635628|NCT04259749|183163634|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.66|4.75|||||Adjusted for age, education, and lifetime tobacco use|||4.75|.66|
91635629|NCT04259749|183163634|OTHER||Odds Ratio (OR)|3.06|||||TWO_SIDED|95.0|1.13|8.29|||||Adjusted for age, education, and lifetime use of tobacco|||8.29|1.13|
91635630|NCT04259749|183163635|OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.51|3.7|||||Adjusted for age, education, and lifetime tobacco use|||3.70|.51|
91635631|NCT04259749|183163635|OTHER||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.85|6.31|||||Adjusted for age, education, and lifetime tobacco use|||6.31|.85|
91635632|NCT04259749|183163636|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.29|4.26|||||Adjusted for age, education, and lifetime tobacco use|||4.26|.29|
91635633|NCT04259749|183163636|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.57|7.06|||||Adjusted for age, education, and lifetime tobacco use|||7.06|.57|
91635634|NCT04259749|183163637|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.33|3.31|||||Adjusted for age, education, and lifetime tobacco use|||3.31|.33|
91635635|NCT04259749|183163637|OTHER||Odds Ratio (OR)|2.43|||||TWO_SIDED|0.95|0.83|7.13|||||Adjusted for age, education, and lifetime tobacco use|||7.13|.83|
91635636|NCT04259749|183163638|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime tobacco use|||4.14|.72|
91635637|NCT04259749|183163638|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime tobacco use|||4.95|.83|
91635638|NCT03922945|183163647|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91635639|NCT03922945|183163648|SUPERIORITY||||||<|0.0017|||||||Cochran-Mantel-Haenszel|||||||<0.0017
91635640|NCT03922945|183163655|SUPERIORITY|||||||0.7465|||||||Mixed Models Analysis|||||||0.7465
91668922|NCT02327325|183232362|SUPERIORITY||Mean Difference (Final Values)|-2.94||||0.08|TWO_SIDED|95.0|-6.24|0.35|||Mixed Models Analysis|||This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.||0.35|-6.24|0.08
91635641|NCT00313716|183163658|SUPERIORITY_OR_OTHER|||||||0.01||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo2 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo2 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 2 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups. Using a one-sided alpha of 0.15, a sample size of 62 subjects in the Epo 2 regimen group and 100 subjects in the placebo group provided 91% power to test the futility hypothesis.||||.01
91668923|NCT02327325|183232362|SUPERIORITY||Mean Difference (Final Values)|-3.26||||0.06|TWO_SIDED|95.0|-6.69|0.06|||Mixed Models Analysis|||This is the comparison of the PA \& CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.||0.06|-6.69|0.06
91485144|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.36|<0.001
91668924|NCT02327325|183232363|SUPERIORITY||Mean Difference (Net)|-6.11||||0.07|TWO_SIDED|95.0|-12.85|0.64|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||0.64|-12.85|0.07
91668925|NCT02327325|183232363|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.28|TWO_SIDED|95.0|-11.69|3.48|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||3.48|-11.69|0.28
91668926|NCT02327325|183232364|SUPERIORITY||Mean Difference (Final Values)|3.64||||0.097|TWO_SIDED|95.0|-0.69|7.96|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||7.96|-0.69|0.097
91668927|NCT02327325|183232364|SUPERIORITY||Mean Difference (Final Values)|2.91||||0.196|TWO_SIDED|95.0|-1.55|7.39|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||7.39|-1.55|0.196
91668928|NCT02327325|183232365|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.01|TWO_SIDED|95.0|-6.85|-1.34|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||-1.34|-6.85|<0.01
91668929|NCT02327325|183232365|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.17|TWO_SIDED|95.0|-4.85|0.86|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||0.86|-4.85|0.17
91668930|NCT02327325|183232366|SUPERIORITY||Median Difference (Final Values)|0.16||||0.95|TWO_SIDED|95.0|-4.86|5.19|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||5.19|-4.86|0.95
91668931|NCT02327325|183232366|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-7.07|1.07|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||1.07|-7.07|0.97
91668932|NCT01118026|183232415|SUPERIORITY|||||||0.9669|||||||Log Rank|||||||0.9669
91668933|NCT00108082|183232443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.7651||95.0|-1.83|2.49|||ANCOVA|||The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.||2.49|-1.83|0.7651
91668934|NCT00108082|183232443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.1711||95.0|-0.7|3.9|||ANCOVA|||||3.90|-0.70|0.1711
91485145|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.43|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.43|<0.001
91668935|NCT01091103|183232465|SUPERIORITY_OR_OTHER|||||||0.9427|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.9427
91668936|NCT01091103|183232466|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.3370
91668937|NCT02780167|183232477|OTHER||Estimate difference|1.8|STANDARD_ERROR_OF_MEAN|0.99||0.121|TWO_SIDED|95.0|-0.7|4.4|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||4.4|-0.7|0.1210
91668938|NCT02780167|183232477|OTHER||Estimate difference|6.0|STANDARD_ERROR_OF_MEAN|3.05||0.1065|TWO_SIDED|95.0|-1.8|13.8|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||13.8|-1.8|0.1065
91668939|NCT02780167|183232477|OTHER||Estimate difference|21.5|STANDARD_ERROR_OF_MEAN|6.25||0.0184|TWO_SIDED|95.0|5.5|37.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||37.6|5.5|0.0184
91668940|NCT02780167|183232477|OTHER||Mean Difference (Final Values)|38.2|STANDARD_ERROR_OF_MEAN|7.18||0.0032|TWO_SIDED|95.0|19.7|56.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||56.6|19.7|0.0032
91668941|NCT02780167|183232478|OTHER||LS mean difference|4.08|STANDARD_ERROR_OF_MEAN|9.667||0.6731|TWO_SIDED|90.0|-11.88|20.05|||Mixed Models Analysis|Mixed-effects model repeated measures (MMRM) with observed cases (OC)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||20.05|-11.88|0.6731
91635642|NCT00313716|183163658|SUPERIORITY_OR_OTHER|||||||0.13||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo1 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo1 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 1 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups.||||0.13
91668942|NCT02780167|183232478|OTHER||LS mean difference|-5.52|STANDARD_ERROR_OF_MEAN|9.474||0.561|TWO_SIDED|90.0|-21.16|10.13|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||10.13|-21.16|0.5610
91668943|NCT02780167|183232478|OTHER||LS mean difference|-23.82|STANDARD_ERROR_OF_MEAN|9.043||0.0091|TWO_SIDED|90.0|-38.76|-8.88|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||-8.88|-38.76|0.0091
91668944|NCT02780167|183232478|OTHER||LS mean difference|-47.35|STANDARD_ERROR_OF_MEAN|9.008|<|0.0001|TWO_SIDED|90.0|-62.23|-32.47|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||-32.47|-62.23|<0.0001
91668945|NCT01067521|183232558|SUPERIORITY||Risk Ratio (RR)|0.656|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.539|0.799||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|"Relapses were estimated by a baseline-adjusted, Negative Binomial Regression with an offset based on the log of subject's exposure to treatment. The model included the following covariates: - Baseline EDSS score. - Log of the prior 2-year number of relapses. - Volume of T2 lesions at baseliner. - Status of Gd-enhancing T1 activity at baseline (=0 no Gd-enhancing T1 at baseline; =1 at least one Gd-enhancing T1 at baseline). - CGR."||0.799|0.539|<0.0001
91668946|NCT01067521|183232559|SUPERIORITY||Risk Ratio (RR)|0.653|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|0.546|0.78||The overall significance level for this study is 5%|Negative binomial regression||GA 40 mg vs. placebo|Negative binomial regression||0.780|0.546|<.0001
91668947|NCT01067521|183232560|SUPERIORITY||Risk Ratio (RR)|0.552|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.436|0.699||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|||0.699|0.436|<0.0001
91668948|NCT01067521|183232561|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.048||0.2058|TWO_SIDED|95.0|-0.154|0.033||The overall significance level for this study is 5%|ANCOVA||GA 40 mg vs Placebo|||0.033|-0.154|0.2058
91485146|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.36|<0.001
91525949|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.62|-0.32|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.32|-0.62|<0.0001
91668949|NCT01067521|183232562|SUPERIORITY||Risk Ratio (RR)|0.8332|STANDARD_ERROR_OF_MEAN|0.0744||0.0409|TWO_SIDED|95.0|0.6995|0.9925||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Entire Study The Negative Binomial Regression model covariates: • treatment group • PCBL (Placebo-Controlled Baseline) Kurtzke's Expanded Disability Status Scale (EDSS) score as 1 degree of freedom variable • Log of the # of relapses in the 2 years prior to PCBL • Volume of T2 lesions at PCBL • Status of Gd-enhancing T1 lesion activity at PCBL (=0 if no Gd-enhancing T1 lesions at PCBL; =1 if at least one Gd-enhancing T1 lesion at PCBL) • Country or Geographical Region (CGR)||0.9925|0.6995|0.0409
91668950|NCT01067521|183232563|SUPERIORITY||Risk Ratio (RR)|0.736|STANDARD_ERROR_OF_MEAN|0.081||0.0056|TWO_SIDED|95.0|0.592|0.914||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 6 Negative binomial regression||0.914|0.592|0.0056
91668951|NCT01067521|183232563|SUPERIORITY||Risk Ratio (RR)|0.633|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.524|0.765||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12 Negative binomial regression||0.765|0.524|<0.0001
91668952|NCT01067521|183232563|SUPERIORITY||Risk Ratio (RR)|0.666|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.557|0.797||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36 Negative binomial regression||0.797|0.557|<0.0001
91668953|NCT01067521|183232564|SUPERIORITY||Risk Ratio (RR)|0.556|STANDARD_ERROR_OF_MEAN|0.093||0.0005|TWO_SIDED|95.0|0.4|0.773||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Month 6||0.773|0.4|0.0005
91485147|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.043|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.043
91668954|NCT01067521|183232564|SUPERIORITY||Risk Ratio (RR)|0.514|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|0.388|0.679||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12||0.679|0.388|<0.0001
91668955|NCT01067521|183232564|SUPERIORITY||Risk Ratio (RR)|0.663|STANDARD_ERROR_OF_MEAN|0.086||0.0015|TWO_SIDED|95.0|0.514|0.854||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36||0.854|0.514|0.0015
91668956|NCT01067521|183232565|SUPERIORITY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.041||0.0425|TWO_SIDED|95.0|-0.166|-0.003||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 6||-0.003|-0.166|0.0425
91668957|NCT01067521|183232565|SUPERIORITY||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.05||0.0844|TWO_SIDED|95.0|-0.184|0.012||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 12||0.012|-0.184|0.0844
91668958|NCT01067521|183232565|SUPERIORITY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.106||0.8701|TWO_SIDED|95.0|-0.91|0.225||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 36||0.225|-0.91|0.8701
91668959|NCT00936351|183232569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
91635643|NCT00313716|183163658|SUPERIORITY_OR_OTHER|||||||0.34|||||||2-sample test of proportions|||We hypothesized that 40% of the patients in the TT7 group would have a favorable GOS score and that there would be no interaction between the Epo and TT groups. Assuming a 2-sided test with an alpha level of 0.05, we estimated that a sample size of 200 patients would provide 80% power to detect a 20% absolute increase in the GOS score for the TT10 group.||||.34
91635644|NCT00313716|183163659|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
91635645|NCT00313716|183163660|SUPERIORITY_OR_OTHER|||||||0.25|||||||Log Rank|||||||.25
91635646|NCT00313716|183163660|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||.75
91635647|NCT00313716|183163660|SUPERIORITY_OR_OTHER|||||||0.72|||||||Log Rank|||||||.72
91635648|NCT00313716|183163661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79||||0.08|TWO_SIDED|95.0|0.93|3.45|||Regression, Cox|||||3.45|.93|.08
91635649|NCT00313716|183163662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.26|TWO_SIDED|95.0|-0.22|0.05|||2-sample test - equality of proportions|||||.05|-.22|.26
91635650|NCT03521089|183163688|SUPERIORITY|||||||0.0039|||||||ANCOVA|||||||0.0039
91668960|NCT02413008|183232584|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.1|||||||Wilcoxon (Mann-Whitney)|||"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.~The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit."||||0.10
91668961|NCT02413008|183232584|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.413|||||||Wilcoxon (Mann-Whitney)|||The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.||||0.413
91525950|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.67|-0.37|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.37|-0.67|<0.0001
91635651|NCT03521089|183163688|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91668962|NCT02413008|183232584|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91668963|NCT02413008|183232585|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 1||||<0.05
91635652|NCT03521089|183163688|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
91635653|NCT03521089|183163689|SUPERIORITY|||||||0.9674|||||||ANCOVA|||||||0.9674
91635654|NCT03521089|183163689|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
91635655|NCT03521089|183163689|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.2500
91635656|NCT03521089|183163690|SUPERIORITY|||||||0.0067|||||||ANCOVA|||||||0.0067
91635657|NCT03521089|183163690|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
91635658|NCT03521089|183163690|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
91635659|NCT03521089|183163691|SUPERIORITY|||||||0.3069|||||||ANCOVA|||||||0.3069
91635660|NCT03521089|183163691|SUPERIORITY|||||||0.1875|||||||Wilcoxon (Mann-Whitney)|||||||0.1875
91635661|NCT03521089|183163691|SUPERIORITY|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
91635662|NCT03521089|183163692|SUPERIORITY|||||||0.2609|||||||ANCOVA|||||||0.2609
91635663|NCT03521089|183163692|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
91635664|NCT03521089|183163692|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
91635665|NCT03521089|183163693|SUPERIORITY|||||||0.6951|||||||ANCOVA|||||||0.6951
91635666|NCT03521089|183163693|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
91635667|NCT03521089|183163693|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
91635668|NCT03521089|183163694|SUPERIORITY|||||||0.3592|||||||ANCOVA|||||||0.3592
91635669|NCT03521089|183163694|SUPERIORITY|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
91635670|NCT03521089|183163694|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
91635671|NCT00772031|183163716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.97||0.77|TWO_SIDED|95.0|-1.8|2.4|||ANCOVA|covariate adjustments: study site, baseline mod-to-sev 28-day headache-rate, topiramate use, medication overuse, and anti-depressive medications use.|Topiramate plus placebo mean reduction minus topiramate plus propranolol reduction|The study was designed to enroll 250 subjects to provide at least 90% power to detect a 3-day difference and 87% power to detect a 2.5-day difference in 28-day moderate-to-severe headache rate reductions at six months, assuming a type I error rate of 0.05, a two-sided test, a 10% loss to follow-up and a standard deviation of within-person change in days with headache of six.||2.4|-1.8|0.77
91635672|NCT00772031|183163717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.75|2.78||||||||2.78|0.75|
91635673|NCT00772031|183163718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.5|2.02||||||||2.02|0.50|
91635674|NCT00772031|183163720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_DEVIATION|3.75||0.91||95.0|||||ANCOVA|||||||0.91
91668964|NCT02413008|183232585|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 3||||<0.05
91668965|NCT02413008|183232585|OTHER||||||>|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 8||||>0.05
91668966|NCT02413008|183232586|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 1||||>0.05
91668967|NCT02413008|183232586|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 3||||>0.05
91668968|NCT02413008|183232586|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 8||||>0.05
91668969|NCT02413008|183232586|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 12||||0.135
91668970|NCT02413008|183232587|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estriol||||0.043
91668971|NCT02413008|183232587|OTHER|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estriol||||0.649
91668972|NCT02413008|183232587|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 8 in plasma levels of estriol||||0.588
91668973|NCT02413008|183232587|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12 in plasma levels of estriol||||0.67
91792681|NCT01293799|183463095|OTHER|The association of factors associated with time to first peritonitis was analysed using the Cox proportional hazard regression model. Subjects were censored for various reasons to leave the study. Univariable Cox regression was used to identify factors associated with with time to first peritonitis episode.|Hazard Ratio (HR)|1.12||||0.0068|TWO_SIDED|95.0|1.03|1.21||Unit of measure: Body weight (hazard ratio per 10 kg). The threshold for statistical significance was P = 0.05.|Regression, Cox|Univariable Cox regression was used.||The association of body weight (HR per 10 kg) with time to first peritonitis episode was analysed by univariable Cox regression (Statistical analysis 1) and multivariable Cox regression (Statistical analysis 2)||1.21|1.03|0.0068
91635675|NCT03474380|183163734|SUPERIORITY|A generalized linear mixed model (GLMM) with a negative binomial distribution and a log link was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods) and site. The final model was adjusted for Veteran characteristics, including age, gender, race, marital status, service connection, rural status, and chronic disease burden concurrence score (Nosos).|rate ratio (RR)|0.58||||0.091|TWO_SIDED|95.0|0.31|1.09|||generalized linear mixed model (GLMM)||Rate ratio, rate of days not in the community in 6 month intervals in intervention versus usual care.|Days not at home in 6 month intervals.||1.09|0.31|0.091
91635676|NCT03474380|183163735|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.8|-0.7|0.98
91668974|NCT02413008|183232588|OTHER|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estradiol.||||0.342
91668975|NCT02413008|183232588|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estradiol.||||0.523
91668976|NCT02413008|183232588|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 8||||0.523
91792682|NCT01293799|183463095|OTHER||Hazard Ratio (HR)|1.1||||0.03|TWO_SIDED|95.0|1.01|1.19||Unit of measure: Body weight (hazard ratio per 10 kg). P \< 0.05 is considered significant.|Regression, Cox|Multivariable Cox regression||The association of body weight (HR per 10 kg) with time to first peritonitis episode was analysed by univariable Cox regression (Statistical analysis 1) and multivariable Cox regression (Statistical analysis 2)||1.19|1.01|0.03
91485148|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.31|0.007
91668977|NCT02413008|183232588|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 12||||0.163
91668978|NCT02413008|183232589|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 1||||0.418
91485149|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.38|<0.001
91668979|NCT02413008|183232589|OTHER|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 3||||0.642
91668980|NCT02413008|183232589|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 8||||0.175
91668981|NCT02413008|183232589|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 12||||0.084
91668982|NCT02413008|183232590|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 3||||<0.01
91668983|NCT02413008|183232590|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 12||||0.057
91668984|NCT02413008|183232591|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 3||||0.14
91668985|NCT02413008|183232591|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 12||||0.25
91668986|NCT02413008|183232592|OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||0.28
91668987|NCT02413008|183232592|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||0.34
91668988|NCT02413008|183232593|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 3||||0.14
91668989|NCT02413008|183232593|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 12||||<0.01
91668990|NCT02413008|183232594|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 3||||0.03
91668991|NCT02413008|183232594|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 12||||0.04
91668992|NCT02413008|183232595|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||<0.001
91668993|NCT02413008|183232595|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa betweeen baseline and week 12||||<0.01
91668994|NCT02413008|183232596|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||0.13
91668995|NCT02413008|183232596|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 12||||<0.01
91668996|NCT02413008|183232597|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||<0.001
91668997|NCT02413008|183232597|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||<0.001
91635677|NCT03474380|183163736|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.4||||0.167|TWO_SIDED|95.0|-0.2|1.0|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||1.0|-0.2|0.167
91635678|NCT03474380|183163737|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|-0.5||||0.122|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.1|-1.0|0.122
91668998|NCT02413008|183232598|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 3 and baseline||||<0.001
91668999|NCT02413008|183232598|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 12 and baseline||||<0.001
91669000|NCT02413008|183232599|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 3||||<0.0001
91669001|NCT02413008|183232599|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 12||||0.006
91669002|NCT03538262|183232613|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
91714691|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8||||0.312||95.0|-4.5|14.1|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.1|-4.5|0.3120
91714692|NCT00676403|183320257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.0442||95.0|0.3|19.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|0.3|0.0442
91714693|NCT00676403|183320258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4452||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4452
91669003|NCT03538262|183232613|OTHER|Statistical analysis for BL to Month 24|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91669004|NCT03538262|183232614|OTHER|||||||0.011|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.011
91714694|NCT00676403|183320258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4342||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4342
91714695|NCT00676403|183320258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.0942
91525951|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.086||0.0008|TWO_SIDED|95.0|-0.46|-0.12|||LS mean difference|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.12|-0.46|0.0008
91635679|NCT01101321|183163738|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|96.14|104.96|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.96|96.14|
91714696|NCT00676403|183320258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1873||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.1873
91714697|NCT00676403|183320258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4709
91669005|NCT03538262|183232614|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
91669006|NCT03538262|183232615|OTHER|||||||0.007|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.007
91669007|NCT03538262|183232615|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
91669008|NCT03538262|183232615|OTHER|||||||0.004|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.004
91669009|NCT03538262|183232615|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
91669010|NCT03538262|183232615|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
91669011|NCT03538262|183232615|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
91669012|NCT03538262|183232615|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
91669013|NCT03538262|183232615|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
91669014|NCT03538262|183232616|OTHER|||||||0.996|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.996
91669015|NCT03538262|183232616|OTHER|||||||0.054|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.054
91669016|NCT03538262|183232616|OTHER|||||||0.025|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.025
91669017|NCT03538262|183232616|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.006
91714698|NCT01272908|183320290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.293||||0.253|||||||Regression, Logistic|||ACR20: Week 12 versus (vs) Week 4||||0.253
91714699|NCT01272908|183320290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.019||||0.005|||||||Regression, Logistic|||ACR20: Week 24 vs Week 4||||0.005
91714700|NCT01272908|183320290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.552||||0.023|||||||Regression, Logistic|||ACR50: Week 12 vs Week 4||||0.023
91714701|NCT01272908|183320290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.861||||0.001|||||||Regression, Logistic|||ACR50: Week 24 vs. Week 4||||0.001
91714702|NCT01272908|183320294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.099||||0.667|||||||Regression, Logistic|||Good vs Moderate vs None: Week 12 vs Week 4||||0.667
91485150|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.36|<0.001
91635680|NCT01101321|183163739|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.44|101.73|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.73|95.44|
91635681|NCT01101321|183163740|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.42|101.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.70|95.42|
91635682|NCT00542321|183163741|SUPERIORITY_OR_OTHER||difference between proportions|0.5||||1|TWO_SIDED|95.0|||||Fisher Exact|Chi-Square = 0.750, df = 1||Pearson Chi-Square Test for difference between groups||||1.00
91635683|NCT00542321|183163742|SUPERIORITY_OR_OTHER||Rank sums|52.0||||1|TWO_SIDED|95.0||||Alpha = .05|Wilcoxon (Mann-Whitney)|||There will be no difference in duration of mechanical ventilation between groups.||||1.0
91635684|NCT00542321|183163743|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.451
91635685|NCT00542321|183163744|SUPERIORITY_OR_OTHER||probability|0.43||||1||95.0|||||Fisher Exact|||||||1.0
91635686|NCT00542321|183163745|SUPERIORITY_OR_OTHER||Rank sums|56.0||||1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0
91635687|NCT01111058|183163757|SUPERIORITY||Difference in survival proportions|0.0022||||0.9|TWO_SIDED|95.0|-0.33|0.33|||Comparison of Kaplan-Meier estimates|Used Greenwood standard errors||||0.33|-0.33|0.90
91635688|NCT01111058|183163757|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
91635689|NCT01111058|183163758|SUPERIORITY|||||||0.086|||||||Fisher Exact|||||||0.086
91635690|NCT01856920|183163766|EQUIVALENCE|Alpha= 0.05||||||0.376|||||||Rank-Sum|||||||0.3760
91635691|NCT02790476|183163768|SUPERIORITY||Mean Difference (Final Values)|-27.8|||<|0.05|TWO_SIDED|95.0|-38.2|-17.63||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (288.36-347.65 = -59.29) and control (318.60-350.09 = -31.49) arms, resulting in a difference of -27.80.|1-3 months post intervention||-17.63|-38.20|<0.05
91635692|NCT02790476|183163768|SUPERIORITY||Mean Difference (Final Values)|-12.42|||<|0.01|TWO_SIDED|95.0|-18.4|-6.55||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (167.83-347.65 = -179.83) and control (182.67-350.09 = -167.41) arms, resulting in a difference of -12.42.|||-6.55|-18.40|<0.01
91635693|NCT02790476|183163769|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.224|TWO_SIDED|95.0|-0.92|0.22||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.45-3.74 = -0.29) and control (3.45-4.59= -0.64) arms, resulting in a difference of -0.35.|Change in mean number of =\> 50 MME prescriptions pre- to 1-3 months post-intervention||0.22|-0.92|0.224
91635694|NCT02790476|183163769|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.00-3.74 = -0.74) and control (3.15-4.59= -1.44) arms, resulting in a difference of -0.70.|Change in mean number of =\> 50 MME prescriptions pre- to 4-12 months post-intervention||-0.33|-1.08|<0.001
91485151|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.074|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.074
91485152|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
91669018|NCT03538262|183232617|OTHER|||||||0.145|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.145
91669019|NCT03538262|183232617|OTHER|||||||0.029|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.029
91669020|NCT03538262|183232618|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<.001
91669021|NCT03538262|183232618|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
91669022|NCT03538262|183232619|OTHER|||||||0.382|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.382
91669023|NCT03538262|183232619|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
91669024|NCT03538262|183232620|OTHER|||||||0.688|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 12||||0.688
91669025|NCT03538262|183232620|OTHER|||||||0.293|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 24||||0.293
91669026|NCT03538262|183232621|OTHER|||||||0.446|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.446
91669027|NCT03538262|183232621|OTHER|||||||0.565|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.565
91669028|NCT03538262|183232622|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
91669029|NCT03538262|183232622|OTHER|||||||0.937|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.937
91669030|NCT03538262|183232623|OTHER|||||||0.041|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.041
91669031|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
91669032|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
91669033|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
91669034|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
91669035|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
91525952|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.086||0.0116|TWO_SIDED|95.0|-0.39|-0.05|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.39|0.0116
91527844|NCT06173570|182930691|SUPERIORITY||Mean Difference (Net)|-19.96|||<|0.001|TWO_SIDED|95.0|-25.09|-14.84|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-14.84|-25.09|< 0.001
91635695|NCT02790476|183163769|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.279|TWO_SIDED|95.0|-0.59|0.17||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.00-2.14 = -0.14) and control (2.20-2.55= -0.35) arms, resulting in a difference of -0.21.|Change in mean number of \> 90 MME prescriptions pre- to 1-3 months post-intervention||0.17|-0.59|0.279
91635696|NCT02790476|183163769|SUPERIORITY||Mean Difference (Final Values)|-0.38|||<|0.01|TWO_SIDED|95.0|-0.63|-0.12||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (1.71-2.14 = -0.43) and control (1.74-2.55= -0.81) arms, resulting in a difference of -0.38.|Change in mean number of \> 90 MME prescriptions pre- to 4-12 months post-intervention||-0.12|-0.63|<0.01
91635697|NCT02790476|183163770|SUPERIORITY||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-3.2|-0.1||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Pre-intervention values were trimmed at 95% with bootstrapped means and confidence intervals.|This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean DME in the letter (72.3-76 = -3.7) and control (82-82.9 = -0.9) arms, resulting in a difference of -1.6.|||-0.1|-3.2|<0.05
91635698|NCT02790476|183163772|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.44-3.72 = -1.28) and control (2.26-3.51= -1.25) arms, resulting in a difference of 0.03.|Change in mean number of new patients pre- to 1-3 months post-intervention||0.29|-0.23|0.823
91635699|NCT02790476|183163772|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.692|TWO_SIDED|95.0|-0.2|0.14||The threshold for statistical significance is p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.08-3.72 = -1.64) and control (1.84-3.51= -1.67) arms, resulting in a difference of -0.03.|Change in mean number of new patients pre- to 4-12 months post-intervention||0.14|-0.20|0.692
91635700|NCT03287089|183163806|SUPERIORITY||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.49|2.43|||Chi-squared|||||2.43|0.49|0.84
91635701|NCT03287089|183163807|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
91635702|NCT03287089|183163808|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|||||||0.68
91635703|NCT00783263|183163809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.25|||<|0.001|TWO_SIDED|95.0|-19.89|-10.6|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.||||-10.60|-19.89|<0.001
91635704|NCT00783263|183163810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.31|||<|0.001|TWO_SIDED|95.0|-18.95|-5.67|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-5.67|-18.95|<0.001
91635705|NCT00783263|183163810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.46|||<|0.001|TWO_SIDED|95.0|-23.92|-10.99|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-10.99|-23.92|<0.001
91635706|NCT00783263|183163811|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.9|6.9|||Logistic Regression|Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: \<100, 100-\<130, ≥130 mg/dL).||||6.9|2.9|<0.001
91669036|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
91669037|NCT03538262|183232623|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
91669038|NCT03538262|183232624|OTHER|||||||0.595|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.595
91669039|NCT03538262|183232624|OTHER|||||||0.44|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.440
91669040|NCT03538262|183232624|OTHER|||||||0.909|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.909
91669041|NCT03538262|183232624|OTHER|||||||0.068|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.068
91669042|NCT03538262|183232625|OTHER|||||||0.074|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.074
91669043|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
91669044|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
91669045|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
91669046|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
91669047|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
91669048|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
91669049|NCT03538262|183232625|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
91669050|NCT03538262|183232626|OTHER|||||||0.2|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.200
91669051|NCT03538262|183232626|OTHER|||||||0.888|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.888
91669052|NCT03538262|183232626|OTHER|||||||0.837|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.837
91635707|NCT00783263|183163812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.1|||<|0.001|TWO_SIDED|95.0|1.7|5.8|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||5.8|1.7|<0.001
91635708|NCT00783263|183163812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.4|12.3|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||12.3|3.4|<0.001
91635709|NCT00783263|183163813|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.0|||<|0.001|TWO_SIDED|95.0|4.6|14.0|||Logistic Regression|||||14.0|4.6|<0.001
91635710|NCT00783263|183163814|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|2.2|11.8|||Logistic Regression|||Stratum I||11.8|2.2|<0.001
91635711|NCT00783263|183163814|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.8|||Logistic Regression|||Stratum II||24.8|5.2|<0.001
91635712|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.65|||<|0.001|TWO_SIDED|95.0|-11.59|-5.71|||Longitudinal Data Analysis|||Total Cholesterol (mg/dL)||-5.71|-11.59|<0.001
91635713|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.306|TWO_SIDED|95.0|-9.04|2.84|||Longitudinal Data Analysis|||Triglycerides (mg/dL)||2.84|-9.04|0.306
91635714|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.111|TWO_SIDED|95.0|-4.79|0.49|||Longitudinal Data Analysis|||High-Density Lipoprotein Cholesterol||0.49|-4.79|0.111
91635715|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.98|||<|0.001|TWO_SIDED|95.0|-16.1|-7.86|||Longitudinal Data Analysis|||Non High-Density Liproprotein Cholesterol||-7.86|-16.10|<0.001
91635716|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.25|||<|0.001|TWO_SIDED|95.0|-18.36|-8.13|||Longitudinal Data Analysis|||LDL Cholesterol/HDL Cholesterol||-8.13|-18.36|<0.001
91635717|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.45||||0.002|TWO_SIDED|95.0|-10.53|-2.36|||Longitudinal Data Analysis|||Total Cholesterol/HDL Cholesterol||-2.36|-10.53|0.002
91635718|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52||||0.001|TWO_SIDED|95.0|-15.3|-3.75|||Longitudinal Data Analysis|||Non-HDL Cholestrol/HDL Cholesterol||-3.75|-15.30|0.001
91635719|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|||<|0.001|TWO_SIDED|95.0|-12.74|-6.08|||Longitudinal Data Analysis|||Apolipoprotein B (Apo B)||-6.08|-12.74|<0.001
91669053|NCT03538262|183232626|OTHER|||||||0.394|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.394
91669054|NCT03538262|183232626|OTHER|||||||0.268|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.268
91635720|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.102|TWO_SIDED|95.0|-3.99|0.36|||Longitudinal Data Analysis|||Apolipoprotein A-I (Apo A-I)||0.36|-3.99|0.102
91635721|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|||<|0.001|TWO_SIDED|95.0|-11.25|-3.83|||Longitudinal Data Analysis|||Apolipoprotein B/Apo A-I||-3.83|-11.25|<0.001
91635722|NCT00783263|183163815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08||||0.861|TWO_SIDED|95.0|-13.13|10.97|||Longitudinal Data Analysis|||hs-C-Reactive Protein||10.97|-13.13|0.861
91635723|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.4|<0.0001
91635724|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
91635725|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.4|-2.0|<0.0001
91669055|NCT03538262|183232626|OTHER|||||||0.039|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.039
91669056|NCT03538262|183232626|OTHER|||||||0.979|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.979
91669057|NCT03538262|183232626|OTHER|||||||0.014|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.014
91669058|NCT03538262|183232627|OTHER|||||||0.285|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.285
91669059|NCT03538262|183232627|OTHER|||||||0.267|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.267
91635726|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|0.3||||0.0799|TWO_SIDED|95.0|0.0|0.6||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-0.0|0.0799
91669060|NCT03538262|183232627|OTHER|||||||0.564|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.564
91669061|NCT03538262|183232627|OTHER|||||||0.034|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.034
91669062|NCT03538262|183232628|OTHER|||||||0.409|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.409
91669063|NCT03538262|183232628|OTHER|||||||0.149|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 0.149||||0.149
91669064|NCT01294449|183232636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.37|TWO_SIDED|95.0|0.67|1.161|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D group over the hazard rate of mortality in the ICD group. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.||1.161|0.670|0.370
91669065|NCT01294449|183232636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.028|TWO_SIDED|95.0|0.484|0.96|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D arm over the hazard rate of mortality in the ICD arm. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)||0.960|0.484|0.028
91669066|NCT03259789|183232654|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.32|-0.74|< 0.0001
91669067|NCT03259789|183232656|SUPERIORITY||Difference of LS Means|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.83|-0.86|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.86|-1.83|< 0.0001
91669068|NCT03259789|183232658|SUPERIORITY||Difference of LS Means|-7.07|||<|0.0001|TWO_SIDED|95.0|-9.83|-4.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-4.32|-9.83|< 0.0001
91669069|NCT03259789|183232659|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0014|TWO_SIDED|95.0|1.7|12.95||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.||12.95|1.70|0.0014
91669070|NCT03259789|183232659|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0001|TWO_SIDED|95.0|1.96|8.92||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.||8.92|1.96|0.0001
91669071|NCT03259789|183232659|SUPERIORITY||Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|95.0|1.31|5.04||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.||5.04|1.31|0.0030
91714703|NCT01272908|183320294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.589|||<|0.001|||||||Regression, Logistic|||Good vs Moderate vs None: Week 24 vs Week 4||||<0.001
91714704|NCT01272908|183320294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.138||||0.44|||||||Regression, Logistic|||Good/Moderate vs None: Week 12 vs Week 4||||0.440
91714705|NCT01272908|183320294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.009||||0.012|||||||Regression, Logistic|||Good/Moderate vs None: Week 24 vs Week 4||||0.012
91714706|NCT01272908|183320296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 4||||<0.001
91714707|NCT01272908|183320296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 12||||<0.001
91714708|NCT01272908|183320296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 24||||<0.001
91714709|NCT01272908|183320296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 36||||<0.001
91714710|NCT01272908|183320296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 48||||<0.001
91714711|NCT01272908|183320298|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed-Rank test|||Baseline vs Week 24||||<0.001
91669072|NCT03259789|183232659|SUPERIORITY||Odds Ratio (OR)|3.88|||<|0.0001|TWO_SIDED|95.0|1.99|7.58||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.||7.58|1.99|< 0.0001
91669073|NCT03259789|183232661|SUPERIORITY||Difference of LS Means|-2.51|||<|0.0001|TWO_SIDED|95.0|-3.45|-1.57|||ANCOVA|ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-1.57|-3.45|< 0.0001
91669074|NCT03259789|183232663|SUPERIORITY||Difference of LS Means|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.38||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.38|-0.74|< 0.0001
91635727|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.1||||0.3942|TWO_SIDED|95.0|-0.4|0.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.2|-0.4|0.3942
91669075|NCT03259789|183232663|SUPERIORITY||Difference of LS Means|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.86|-0.46||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.46|-0.86|< 0.0001
91669076|NCT03259789|183232663|SUPERIORITY||Difference of LS Means|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.30|-0.69|< 0.0001
91669077|NCT03259789|183232663|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.32|-0.74|< 0.0001
91669078|NCT04718129|183232710|SUPERIORITY||Mean Difference (Net)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.048|TWO_SIDED|95.0|0.003|0.085|||Regression, Linear|||||.085|.003|.048
91669079|NCT02212457|183232711|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.53|1.02|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||1.02|0.53|
91669080|NCT02212457|183232711|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.94|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.94|0.54|
91669081|NCT02212457|183232711|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.85|0.51|
91714712|NCT01272908|183320300|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
91669082|NCT02212457|183232711|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.49|||||TWO_SIDED|95.0|0.37|0.66|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.66|0.37|
91669083|NCT00688844|183232758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.655574|STANDARD_DEVIATION|8.060658||0.692782|||||||t-test, 2 sided|||Objective was to evaluate BMI across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.692782
91669084|NCT00688844|183232759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005401|STANDARD_DEVIATION|0.0243|<|0.001|||||||t-test, 2 sided|||Objective was to evaluate total body bone mineral density (BMD) one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||<0.001
91714713|NCT01272908|183320302|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
91635728|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.3||||0.0272|TWO_SIDED|95.0|-0.6|0.0||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurement||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.0|-0.6|0.0272
91635729|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.5|-1.1|<0.0001
91635730|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.5|<0.0001
91635731|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-1.7|<0.0001
91635732|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|0.2||||0.1958|TWO_SIDED|95.0|-0.1|0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.1|0.1958
91635733|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.2||||0.1868|TWO_SIDED|95.0|-0.5|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-0.5|0.1868
91635734|NCT03018028|183163818|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4||||0.0077|TWO_SIDED|95.0|-0.7|-0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.7|0.0077
91669085|NCT00688844|183232760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.419224|STANDARD_DEVIATION|3.4666||0.017941|||||||t-test, 2 sided|||Objective was to evaluate % lean mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.017941
91669086|NCT00688844|183232761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.208889|STANDARD_DEVIATION|3.51967||0.026009|||||||t-test, 2 sided|||Objective was to evaluate % fat mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.026009
91714714|NCT01272908|183320304|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
91714715|NCT01272908|183320306|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
91635735|NCT03018028|183163845|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.2579|TWO_SIDED|95.0|0.29|1.4||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.40|0.29|0.2579
91635736|NCT03018028|183163845|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.25||||0.0052|TWO_SIDED|95.0|0.1|0.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.66|0.10|0.0052
91635737|NCT03018028|183163845|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31||||0.0259|TWO_SIDED|95.0|0.11|0.87||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.87|0.11|0.0259
91635738|NCT03018028|183163845|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.7||||0.0674|TWO_SIDED|95.0|0.93|7.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||7.80|0.93|0.0674
91635739|NCT03018028|183163845|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.07||||0.9087|TWO_SIDED|95.0|0.32|3.54||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.54|0.32|0.9087
91635740|NCT03018028|183163845|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33||||0.6498|TWO_SIDED|95.0|0.38|4.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||4.62|0.38|0.6498
91669087|NCT00688844|183232762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.5187|STANDARD_DEVIATION|362.9412||0.303864|||||||t-test, 2 sided|||Objective was to evaluate plasma phenylalanine across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.303864
91669088|NCT00688844|183232763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9549|STANDARD_DEVIATION|20.10814||0.00088|||||||t-test, 2 sided|||Objective was to evaluate protein intake (grams per day) across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.00088
91669089|NCT00688844|183232764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131676|STANDARD_DEVIATION|0.797247||0.3811|||||||t-test, 2 sided|||Objective was to evaluate dietary phenylalanine intake across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.3811
91669090|NCT01745952|183232793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9819|TWO_SIDED||||||negative binomial model + overdispersion|||||||0.9819
91669091|NCT00493792|183232814|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.47|TWO_SIDED|95.0|0.29|1.77|||Regression, Cox|||||1.77|0.29|0.47
91635741|NCT03018028|183163846|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.34||||0.0219|TWO_SIDED|95.0|0.14|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.14|0.0219
91669092|NCT00493792|183232815|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.06|TWO_SIDED|95.0|0.23|1.03|||Regression, Cox|||||1.03|0.23|0.06
91714716|NCT01272908|183320308|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
91714717|NCT01272908|183320310|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
91669093|NCT00493792|183232816|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.193|TWO_SIDED|95.0|0.45|1.18|||Regression, Cox|||||1.18|.45|0.193
91669094|NCT00685035|183232822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.23||0.02|TWO_SIDED|95.0|||||ANCOVA|||||||.02
91669095|NCT02426541|183232829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.3794|TWO_SIDED|95.0|-2.18|5.54|||ANCOVA|Adjusted for sex and baseline||||5.54|-2.18|0.3794
91714718|NCT01272908|183320312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
91635742|NCT03018028|183163846|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15||||0.0005|TWO_SIDED|95.0|0.05|0.44||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.44|0.05|0.0005
91669096|NCT02426541|183232830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.5317|TWO_SIDED|95.0|-5.6|2.96|||ANCOVA|Adjusted for sex and baseline||||2.96|-5.60|0.5317
91669097|NCT02426541|183232831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003||||0.9984|TWO_SIDED|95.0|-3.07|3.07|||ANCOVA|Adjusted for sex and baseline||||3.07|-3.07|0.9984
91669098|NCT00745134|183232834|OTHER|||||||0.33|||||||ANOVA|||||||0.33
91669099|NCT02344745|183232898|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91669100|NCT02344745|183232899|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
91669101|NCT02344745|183232900|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91669102|NCT02344745|183232901|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
91669103|NCT02788513|183232902|OTHER|||||||0.9931||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Beta model fit.|Model assumption: 75% of max effect is achieved at 2 mg, 87.5% at 5 mg, 25% at 25 mg, max effect achieved at 10 mg of BI 425809, scalar parameter = 26||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9931
91669104|NCT02788513|183232902|OTHER|||||||0.9225||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit.|Model assumption: 20% of the maximum effect is achieved at 2 mg||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9225
91669105|NCT02788513|183232902|OTHER|||||||0.9287||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Sigmoidal Emax model fit.|Model assumption: 25% of max effect achieved at 5 mg and 75% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9287
91669106|NCT02788513|183232902|OTHER|||||||0.7646||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.7646
91714719|NCT01272908|183320316|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 12||||<0.001
91714720|NCT01272908|183320316|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
91669107|NCT02788513|183232902|OTHER|||||||0.9335||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear in log model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9335
91669108|NCT02788513|183232902|OTHER|||||||0.8199||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod logistic model fit.|Model assumption: 10% of max effect achieved at 5 mg and 50% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.8199
91669109|NCT02788513|183232902|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.58||0.934|TWO_SIDED|95.0|-1.09|1.18||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.18|-1.09|0.9340
91669110|NCT02788513|183232902|OTHER||Median Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.6041|TWO_SIDED|95.0|-0.84|1.44||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.44|-0.84|0.6041
91669111|NCT02788513|183232902|OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.58||0.1926|TWO_SIDED|95.0|-0.38|1.9||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.90|-0.38|0.1926
91669112|NCT02788513|183232902|OTHER||Median Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.58||0.9739|TWO_SIDED|95.0|-1.16|1.12||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.12|-1.16|0.9739
91669113|NCT02788513|183232903|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.76||0.979|TWO_SIDED|95.0|-1.48|1.52||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||1.52|-1.48|0.979
91669114|NCT02788513|183232903|OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.77||0.521|TWO_SIDED|95.0|-1.01|2.0||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||2.00|-1.01|0.521
91669115|NCT02788513|183232903|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.77||0.047|TWO_SIDED|95.0|-3.04|-0.02||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.02|-3.04|0.047
91669116|NCT02788513|183232903|OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED|95.0|-3.65|-0.67||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.67|-3.65|0.005
91669117|NCT02788513|183232904|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.343|TWO_SIDED|95.0|-0.32|0.11||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.11|-0.32|0.343
91714721|NCT00905424|183320333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.0902|TWO_SIDED|90.0|-4.5|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-4.5|0.0902
91714722|NCT00905424|183320334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.3091|TWO_SIDED|90.0|-2.4|0.6||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.6|-2.4|0.3091
91669118|NCT02788513|183232904|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.645|TWO_SIDED|95.0|-0.26|0.16||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.16|-0.26|0.645
91669119|NCT02788513|183232904|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.448|TWO_SIDED|95.0|-0.13|0.3||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.30|-0.13|0.448
91669120|NCT02788513|183232904|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.11|0.32||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.32|-0.11|0.340
91669121|NCT04443569|183232918|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Post-Op Day 1||||0.3
91669122|NCT04443569|183232918|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Post-Op Day 2||||0.9
91669123|NCT04443569|183232918|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Post-Op Day 3||||0.07
91669124|NCT04443569|183232918|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Post-Op Day 4||||0.09
91525953|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.093||0.0416|TWO_SIDED|95.0|-0.37|-0.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-0.37|0.0416
91669125|NCT04443569|183232919|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91669126|NCT01933919|183232928|SUPERIORITY||LS Mean Difference (Fluvoxamine-Placebo)|-4.3|STANDARD_ERROR_OF_MEAN|2.07||0.044|TWO_SIDED|95.0|-8.5|-0.1|||ANCOVA|ANCOVA with baseline JCY-BOCS (10-item) total score and age as covariates and treatment as fixed effect.|The model included the fixed effects of treatment, with baseline JCY-BOCS (10-item) total score and age as covariates.|||-0.1|-8.5|0.044
91669127|NCT00809965|183232989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based upon the Cox proportional hazards model|||0.97|0.72|0.020
91714723|NCT00905424|183320335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0573|TWO_SIDED|90.0|-3.7|-0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.3|-3.7|0.0573
91714724|NCT00905424|183320336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2368||95.0|||||Cochran-Mantel-Haenszel|||||||0.2368
91714725|NCT00905424|183320339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.0463|TWO_SIDED|90.0|-5.4|-0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||-0.5|-5.4|0.0463
91714726|NCT00905424|183320339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.1431|TWO_SIDED|90.0|-4.3|0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||0.3|-4.3|0.1431
91669128|NCT00809965|183232989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.028|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based upon the Cox proportional hazards model|||0.98|0.73|0.028
91669129|NCT00809965|183232990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based on the Cox proportional hazards model|||0.97|0.72|0.016
91669130|NCT00809965|183232990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.025|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based on the Cox proportional hazards model|||0.98|0.73|0.025
91669131|NCT00809965|183232991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Log Rank||Based upon the Cox proportional hazards model|||1.07|0.81|0.320
91669132|NCT00809965|183232991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.508|TWO_SIDED|95.0|0.83|1.1|||Log Rank||Based upon the Cox proportional hazards model|||1.10|0.83|0.508
91669133|NCT00809965|183232992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.185|TWO_SIDED|95.0|0.8|1.04|||Log Rank||Based upon the Cox proportional hazards model|||1.04|0.80|0.185
91669134|NCT00809965|183232992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.081|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.081
91669135|NCT00809965|183232993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.011|TWO_SIDED|95.0|0.73|0.96|||Log Rank||Based upon the Cox proportional hazards model|||0.96|0.73|0.011
91669136|NCT00809965|183232993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.07|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.070
91669137|NCT05552261|183232999|OTHER||Mean Difference (Final Values)|-2.8||||0.5158|TWO_SIDED|95.0|-6.7|1.2|||Wilcoxon signed-rank|||||1.2|-6.7|0.5158
91669138|NCT05552261|183232999|OTHER||Mean Difference (Final Values)|-4.9||||0.067|TWO_SIDED|95.0|-9.2|-0.6|||Wilcoxon signed-rank|||||-0.6|-9.2|0.0670
91669139|NCT05552261|183232999|OTHER||Mean Difference (Final Values)|-0.8||||0.6307|TWO_SIDED|95.0|-4.4|2.8|||Wilcoxon signed-rank|||||2.8|-4.4|0.6307
91669140|NCT05552261|183232999|OTHER||Mean Difference (Final Values)|-3.1||||0.0357|TWO_SIDED|95.0|-5.6|-0.6|||Wilcoxon signed-rank|||||-0.6|-5.6|0.0357
91669141|NCT05552261|183233000|OTHER||Mean Difference (Final Values)|0.695||||0.2836|TWO_SIDED|95.0|-0.353|1.743|||Wilcoxon signed-rank|||||1.743|-0.353|0.2836
91669142|NCT05552261|183233000|OTHER||Mean Difference (Final Values)|0.539||||0.5153|TWO_SIDED|95.0|-0.55|1.628|||Wilcoxon signed-rank|||||1.628|-0.550|0.5153
91669143|NCT05552261|183233000|OTHER||Mean Difference (Final Values)|-0.384||||0.253|TWO_SIDED|95.0|-1.295|0.527|||Wilcoxon signed-rank|||||0.527|-1.295|0.2530
91669144|NCT05552261|183233000|OTHER||Mean Difference (Final Values)|-0.561||||0.3828|TWO_SIDED|95.0|-1.574|0.451|||Wilcoxon signed-rank|||||0.451|-1.574|0.3828
91669145|NCT05552261|183233002|OTHER||Mean Difference (Final Values)|-0.023||||0.745|TWO_SIDED|95.0|-0.11|0.064|||Wilcoxon signed-rank|||||0.064|-0.110|0.7450
91669146|NCT05552261|183233002|OTHER||Mean Difference (Final Values)|0.124|||<|0.0001|TWO_SIDED|95.0|0.071|0.177|||Wilcoxon signed-rank|||||0.177|0.071|<0.0001
91669147|NCT05552261|183233002|OTHER||Mean Difference (Final Values)|-0.056||||0.1619|TWO_SIDED|95.0|-0.134|0.021|||Wilcoxon signed-rank|||||0.021|-0.134|0.1619
91669148|NCT05552261|183233002|OTHER||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.02|0.154|||Wilcoxon signed-rank|||||0.154|0.020|0.0100
91669149|NCT04269993|183233007|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
91669150|NCT01628549|183233009|SUPERIORITY||Difference in Least Squares Means|1.53||||0.4344|TWO_SIDED|95.0|-2.32|5.38|||ANCOVA|||||5.38|-2.32|0.4344
91669151|NCT01628549|183233009|SUPERIORITY||Difference in Least Squares Means|4.46||||0.0266|TWO_SIDED|95.0|0.52|8.4|||ANCOVA|||||8.40|0.52|0.0266
91669152|NCT01628549|183233009|SUPERIORITY||Difference in Least Squares Means|4.37||||0.0317|TWO_SIDED|95.0|0.39|8.36|||ANCOVA|||||8.36|0.39|0.0317
91669153|NCT01628549|183233010|SUPERIORITY||Difference vs placebo in success rate|3.4||||0.33|TWO_SIDED|95.0|-7.82|14.38|||Cochran-Mantel-Haenszel|||||14.38|-7.82|0.3300
91669154|NCT01628549|183233010|SUPERIORITY||Difference vs placebo in success rate|13.2||||0.0159|TWO_SIDED|95.0|0.54|25.6|||Cochran-Mantel-Haenszel|||||25.60|0.54|0.0159
91669155|NCT01628549|183233010|SUPERIORITY||Difference vs placebo in success rate|4.1||||0.4834|TWO_SIDED|95.0|-7.44|15.87|||Cochran-Mantel-Haenszel|||||15.87|-7.44|0.4834
91669156|NCT03807440|183233028|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
91485153|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
91485154|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.49|-0.23|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.49|<0.001
91485155|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.236|TWO_SIDED|95.0|-0.21|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.21|0.236
91525954|NCT03502616|182927255|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.092||0.0915|TWO_SIDED|95.0|-0.34|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.34|0.0915
91669157|NCT03807440|183233029|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669158|NCT03807440|183233030|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
91669159|NCT03807440|183233031|OTHER|||||||0.8071|||||||Chi-squared|||||||0.8071
91669160|NCT03807440|183233031|OTHER|||||||0.764|||||||Fisher Exact|||||||0.7640
91669161|NCT03807440|183233032|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
91669162|NCT03807440|183233033|OTHER|||||||0.0042|||||||Chi-squared|||||||0.0042
91669163|NCT03807440|183233034|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
91669164|NCT03807440|183233035|OTHER|||||||0.399|||||||Chi-squared|||||||0.3990
91669165|NCT03807440|183233035|OTHER|||||||0.3842|||||||Fisher Exact|||||||0.3842
91669166|NCT03807440|183233036|OTHER|||||||0.0605|||||||Kruskal-Wallis|||||||0.0605
91669167|NCT03807440|183233037|OTHER|||||||0.6329|||||||Chi-squared|||||||0.6329
91669168|NCT03807440|183233037|OTHER|||||||0.7181|||||||Fisher Exact|||||||0.7181
91669169|NCT03807440|183233038|OTHER|||||||0.5233|||||||Kruskal-Wallis|||||||0.5233
91669170|NCT03807440|183233040|OTHER|||||||0.3662|||||||Kruskal-Wallis|||||||0.3662
91669171|NCT03807440|183233041|OTHER|||||||0.511|||||||Kruskal-Wallis|||||||0.5110
91669172|NCT03807440|183233042|OTHER|||||||0.0921|||||||Kruskal-Wallis|||||||0.0921
91669173|NCT03807440|183233043|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
91669174|NCT03807440|183233044|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669175|NCT03807440|183233045|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
91669176|NCT03807440|183233046|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669177|NCT03807440|183233047|OTHER|||||||0.3201|||||||Kruskal-Wallis|||||||0.3201
91669178|NCT03807440|183233048|OTHER|||||||0.3288|||||||Chi-squared|||||||0.3288
91669179|NCT03807440|183233048|OTHER|||||||0.171|||||||Fisher Exact|||||||0.1710
91669180|NCT03807440|183233049|OTHER|||||||0.013|||||||Kruskal-Wallis|||||||0.0130
91669181|NCT03807440|183233050|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
91669182|NCT03807440|183233051|OTHER|||||||0.3978|||||||Kruskal-Wallis|||||||0.3978
91669183|NCT03807440|183233052|OTHER|||||||0.0055|||||||Chi-squared|||||||0.0055
91669184|NCT03807440|183233052|OTHER|||||||0.0041|||||||Fisher Exact|||||||0.0041
91669185|NCT03807440|183233053|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669186|NCT03807440|183233054|OTHER|||||||0.0399|||||||Chi-squared|||||||0.0399
91669187|NCT03807440|183233054|OTHER|||||||0.0401|||||||Fisher Exact|||||||0.0401
91669188|NCT03807440|183233072|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669189|NCT03807440|183233073|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669190|NCT03807440|183233074|OTHER|||||||0.0008|||||||Chi-squared|||||||0.0008
91669191|NCT03807440|183233076|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669192|NCT03807440|183233077|OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
91669193|NCT03807440|183233078|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669194|NCT03807440|183233079|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669195|NCT03807440|183233080|OTHER|||||||0.9184|||||||Chi-squared|||||||0.9184
91669196|NCT03807440|183233080|OTHER|||||||0.9911|||||||Fisher Exact|||||||0.9911
91669197|NCT03807440|183233081|OTHER|||||||0.6967|||||||Chi-squared|||||||0.6967
91669198|NCT03807440|183233081|OTHER|||||||0.6439|||||||Fisher Exact|||||||0.6439
91669199|NCT03807440|183233082|OTHER|||||||0.9414|||||||Chi-squared|||||||0.9414
91669200|NCT03807440|183233082|OTHER|||||||0.8142|||||||Fisher Exact|||||||0.8142
91669201|NCT03807440|183233083|OTHER|||||||0.7837|||||||Chi-squared|||||||0.7837
91669202|NCT03807440|183233083|OTHER|||||||0.7538|||||||Fisher Exact|||||||0.7538
91669203|NCT03807440|183233084|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
91669204|NCT03807440|183233085|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669205|NCT03807440|183233086|OTHER|||||||0.1906|||||||Chi-squared|||||||0.1906
91635743|NCT03018028|183163846|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.23||||0.0098|TWO_SIDED|95.0|0.07|0.7||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.70|0.07|0.0098
91635744|NCT03018028|183163846|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.95||||0.1193|TWO_SIDED|95.0|0.76|11.46||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||11.46|0.76|0.1193
91635745|NCT03018028|183163846|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.31||||0.7147|TWO_SIDED|95.0|0.31|5.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||5.56|0.31|0.7147
91635746|NCT03018028|183163846|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.97||||0.3765|TWO_SIDED|95.0|0.44|8.85||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||8.85|0.44|0.3765
91669206|NCT03807440|183233087|OTHER|||||||0.6198|||||||Chi-squared|||||||0.6198
91669207|NCT03807440|183233087|OTHER|||||||0.7297|||||||Fisher Exact|||||||0.7297
91669208|NCT03807440|183233089|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669209|NCT03807440|183233090|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
91669210|NCT03807440|183233090|OTHER|||||||0.0002|||||||Fisher Exact|||||||0.0002
91669211|NCT03807440|183233091|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
91669212|NCT03807440|183233094|OTHER|||||||0.003|||||||Log Rank|||||||0.0030
91669213|NCT01332968|183233136|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.0012|TWO_SIDED|95.0|0.51|0.85|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.85|0.51|0.0012
91714727|NCT00905424|183320339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0281|TWO_SIDED|90.0|-5.8|-0.8||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||-0.8|-5.8|0.0281
91714728|NCT00905424|183320340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.092|TWO_SIDED|90.0|-6.0|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-6.0|0.0920
91669214|NCT01332968|183233137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.93|0.64|0.0055
91669215|NCT01332968|183233138|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0028|TWO_SIDED|95.0|0.65|0.91|||Log Rank|||||0.91|0.65|0.0028
91669216|NCT01332968|183233139|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0118|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||||0.93|0.56|0.0118
91669217|NCT01332968|183233140|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0038||95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0038
91669218|NCT01332968|183233141|SUPERIORITY||Absolute difference in %|1.8||||0.3|TWO_SIDED|95.0|-2.02|5.68|||Log Rank|||Without PET||5.68|-2.02|0.30
91669219|NCT01332968|183233141|SUPERIORITY||Absolute difference in %|4.3||||0.17|TWO_SIDED|95.0|-1.8|10.5|||Log Rank|||With PET||10.5|-1.8|0.17
91669220|NCT01332968|183233142|SUPERIORITY||Absolute difference in %|1.6||||0.33|TWO_SIDED|95.0|-2.0|5.3|||Log Rank|||Without PET||5.3|-2.0|0.33
91669221|NCT01332968|183233142|SUPERIORITY||Absolute difference in %|3.5||||0.17|TWO_SIDED|95.0|-2.3|9.4|||Log Rank|||With PET||9.4|-2.3|0.17
91669222|NCT01332968|183233143|SUPERIORITY||Absolute difference in %|-5.5||||0.02|TWO_SIDED|95.0|-10.2|-0.78|||Log Rank|||Without PET||-0.78|-10.2|0.02
91669223|NCT01332968|183233143|SUPERIORITY||Absolute difference in %|5.2||||0.32|TWO_SIDED|95.0|-2.8|13.3|||Log Rank|||With PET||13.3|-2.8|0.32
91669224|NCT01332968|183233144|SUPERIORITY||Absolute difference in %|-4.9||||0.02||95.0|-9.3|0.6|||Log Rank|||Without PET||0.6|-9.3|0.02
91669225|NCT01332968|183233144|SUPERIORITY||Absolute difference in %|4.1||||0.33||95.0|-3.6|11.8|||Log Rank|||With PET||11.8|-3.6|0.33
91669226|NCT01332968|183233145|SUPERIORITY||Absolute difference in %|3.3||||0.052|TWO_SIDED|95.0|-0.19|6.85|||Log Rank|||Without PET||6.85|-0.19|0.052
91669227|NCT01332968|183233145|SUPERIORITY||Absolute difference in %|3.3||||0.3|TWO_SIDED|95.0|-2.3|8.9|||Log Rank|||With PET||8.9|-2.3|0.30
91669228|NCT01332968|183233146|SUPERIORITY||Absolute difference in %|3.2||||0.049|TWO_SIDED|95.0|-0.3|6.6|||Log Rank|||Without PET||6.6|-0.3|0.049
91669229|NCT01332968|183233146|SUPERIORITY||Absolute difference in %|3.9||||0.22|TWO_SIDED|95.0|-1.7|9.5|||Log Rank|||With PET||9.5|-1.7|0.22
91669230|NCT01332968|183233147|SUPERIORITY||Absolute difference in %|1.7||||0.58|TWO_SIDED|95.0|-3.5|6.8|||Log Rank|||Without PET||6.8|-3.5|0.58
91669231|NCT01332968|183233147|SUPERIORITY||Absolute difference in %|11.7||||0.006|TWO_SIDED|95.0|3.9|19.4|||Log Rank|||||19.4|3.9|0.006
91669232|NCT01332968|183233148|SUPERIORITY||Absolute difference in %|0.7||||0.8|TWO_SIDED|95.0|-4.0|5.5|||Log Rank|||Without PET||5.5|-4.0|0.80
91669233|NCT01332968|183233148|SUPERIORITY||Absolute difference in %|10.1||||0.009||95.0|2.6|17.6|||Log Rank|||With PET||17.6|2.6|0.009
91669234|NCT01332968|183233149|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3577||95.0|0.63|1.18|||Log Rank|||||1.18|0.63|0.3577
91669235|NCT01332968|183233150|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.25||95.0|0.58|1.16|||Log Rank|||||1.16|0.58|0.25
91669236|NCT01332968|183233151|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0015|TWO_SIDED|95.0|0.62|0.89|||Log Rank|||||0.89|0.62|0.0015
91669237|NCT01332968|183233152|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0004||95.0|0.56|0.85|||Log Rank|||||0.85|0.56|0.0004
91792683|NCT01293799|183463096|OTHER||Hazard Ratio (HR)|1.2||||0.012|TWO_SIDED|95.0|1.04|1.38||Unit of measure: Body mass index (hazard ratio per 5 kg/m2). P \< 0,05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression.||"The association of Diabetic nephropathy as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found."||1.38|1.04|0.012
91635747|NCT02519777|183163868|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.60
91635748|NCT02519777|183163868|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.33
91635749|NCT02519777|183163868|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.61
91635750|NCT02519777|183163870|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.61
91635751|NCT02519777|183163870|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.72
91635752|NCT02519777|183163870|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.79
91635753|NCT02519777|183163870|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.55
91635754|NCT02519777|183163870|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.47
91635755|NCT02519777|183163870|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.95
91635756|NCT02519777|183163870|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.85
91669238|NCT01332968|183233153|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.71|1.27|||Log Rank|||||1.27|0.71|
91669239|NCT01332968|183233154|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.5|1.19||||||||1.19|0.50|
91669240|NCT01332968|183233155|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.93|||Log Rank|||||0.93|0.63|
91669241|NCT01332968|183233156|SUPERIORITY||Hazard Ratio (HR)|0.69||||||95.0|0.55|0.88||||||||0.88|0.55|
91669242|NCT01332968|183233157|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.001|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.001
91635757|NCT02519777|183163870|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.67
91669243|NCT01332968|183233158|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004||95.0|0.54|0.89|||Log Rank|||||0.89|0.54|0.004
91669244|NCT00721955|183233167|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
91669245|NCT00721955|183233167|SUPERIORITY|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
91669246|NCT00721955|183233168|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
91669247|NCT00721955|183233168|SUPERIORITY||||||<|0.0001||||||-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
91669248|NCT03702816|183233170|OTHER|Linear Regression||||||0.6|||||||Regression, Linear|F=0.308||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.60
91669249|NCT03702816|183233170|OTHER|Linear Regression||||||0.56|||||||Regression, Linear|F=0.367||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.56
91669250|NCT03702816|183233170|OTHER|Linear regression||||||0.44|||||||Regression, Linear|||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.44
91669251|NCT03702816|183233170|OTHER|Linear Regression||||||0.15|||||||Regression, Linear|F=2.55||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.15
91669252|NCT03702816|183233170|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=0.947||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.39
91669253|NCT03702816|183233170|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.004||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.95
91669254|NCT03702816|183233170|OTHER|Linear Regulation||||||0.53|||||||Regression, Linear|F=0.483||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.53
91669255|NCT03702816|183233170|OTHER|Linear Regression||||||0.19|||||||Regression, Linear|F=2.543||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.19
91525955|NCT03502616|182927256|SUPERIORITY||LS mean difference|2.85|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|1.46|4.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.24|1.46|<0.0001
91635758|NCT02519777|183163870|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.70
91635759|NCT02519777|183163871|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 24 from baseline||||0.99
91669256|NCT03702816|183233170|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=3.430||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.32
91669257|NCT03702816|183233170|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=32.844||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.11
91669258|NCT03702816|183233170|OTHER|Linear Regression||||||0.31|||||||Regression, Linear|F=3.559||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.31
91669259|NCT03702816|183233170|OTHER|Linear Regression||||||0.005|||||||Regression, Linear|F=14362.699||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.005
91669260|NCT03702816|183233170|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.056||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.84
91669261|NCT03702816|183233170|OTHER|Linear Regression||||||0.94|||||||Regression, Linear|F=0.008||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.94
91669262|NCT03702816|183233170|OTHER|Linear Regression||||||0.29|||||||Regression, Linear|F=2.01||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.29
91669263|NCT03702816|183233170|OTHER|Linear Regression||||||0.72|||||||Regression, Linear|F=0.173||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.72
91669264|NCT03702816|183233171|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.424||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.54
91669265|NCT03702816|183233171|OTHER|Linear Regression||||||0.53|||||||Regression, Linear|F=0.447||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.53
91669266|NCT03702816|183233171|OTHER|Linear Regression||||||0.23|||||||Regression, Linear|F=1.773||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.23
91635760|NCT02519777|183163871|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 48 from baseline||||0.97
91669267|NCT03702816|183233171|OTHER|Linear Regression||||||0.01|||||||Regression, Linear|F=3.615||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.01
91669268|NCT03702816|183233171|OTHER|Linear Regression||||||0.039|||||||Regression, Linear|F=9.204||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.039
91669269|NCT03702816|183233171|OTHER|Linear Regression||||||0.33|||||||Regression, Linear|F=1.209||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.33
91669270|NCT03702816|183233171|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=5.801||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.07
91669271|NCT03702816|183233171|OTHER|Linear Regression||||||0.03|||||||Regression, Linear|F=10.374||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.03
91669272|NCT03702816|183233171|OTHER|Linear Regression||||||0.27|||||||Regression, Linear|F=5.024||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.27
91669273|NCT03702816|183233171|OTHER|Linear Regression||||||0.16|||||||Regression, Linear|F=15.568||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.16
91669274|NCT03702816|183233171|OTHER|Linear Regression||||||0.262|||||||Regression, Linear|F=5.238||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.262
91669275|NCT03702816|183233171|OTHER|Linear Regression||||||0.043|||||||Regression, Linear|F=221.308||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.043
91669276|NCT03702816|183233171|OTHER|Linear Regression||||||0.26|||||||Regression, Linear|F=2.430||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.26
91669277|NCT03702816|183233171|OTHER|Linear Regression||||||0.38|||||||Regression, Linear|F=1.269||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.38
91669278|NCT03702816|183233171|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=13.164||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.07
91669279|NCT03702816|183233171|OTHER|Linear Regression||||||0.37|||||||Regression, Linear|F=1.312||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.37
91669280|NCT03702816|183233172|OTHER|Linear Regression||||||0.64|||||||Regression, Linear|F=0.233||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.64
91669281|NCT03702816|183233172|OTHER|Linear Regression||||||0.92|||||||Regression, Linear|F=0.011||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.92
91669282|NCT03702816|183233172|OTHER|Linear Regression||||||0.22|||||||Regression, Linear|F=1.790||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.22
91669283|NCT03702816|183233172|OTHER|Linear Regression||||||0.42|||||||Regression, Linear|F=0.720||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.42
91669284|NCT03702816|183233172|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.305||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.61
91669285|NCT03702816|183233172|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.95
91714729|NCT00905424|183320341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0774|TWO_SIDED|90.0|-2.2|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.2|0.0774
91714730|NCT00905424|183320342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.4726|TWO_SIDED|90.0|-1.6|4.0||The test was performed a priori at the significance level of 0.10|ANCOVA|||||4.0|-1.6|0.4726
91635761|NCT02519777|183163871|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 72 from baseline||||0.79
91635762|NCT02519777|183163871|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 96 from baseline||||0.99
91714731|NCT00905424|183320343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.5182|TWO_SIDED|90.0|-1.4|3.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||3.1|-1.4|0.5182
91714732|NCT00905424|183320344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.463|TWO_SIDED|90.0|-3.1|1.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||||1.2|-3.1|0.4630
91714733|NCT00905424|183320345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.523||95.0|||||Cochran-Mantel-Haenszel|||||||0.5230
91485156|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.112|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.112
91635763|NCT02519777|183163871|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.74
91635764|NCT02519777|183163871|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.69
91635765|NCT02519777|183163871|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.44
91635766|NCT02519777|183163871|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
91635767|NCT02519777|183163871|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.83
91635768|NCT02519777|183163871|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.80
91635769|NCT02519777|183163871|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.86
91635770|NCT02519777|183163871|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
91635771|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|3.32|||||TWO_SIDED|95.0|-2.78|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-2.78|
91635772|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|5.17|||||TWO_SIDED|95.0|-0.53|10.87||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.87|-0.53|
91635773|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|-8.21|||||TWO_SIDED|95.0|-16.56|0.13||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||0.13|-16.56|
91635774|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|3.17|||||TWO_SIDED|95.0|-3.07|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-3.07|
91714734|NCT00905424|183320348|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.2876|TWO_SIDED|90.0|-1.0|4.7||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||4.7|-1.0|0.2876
91714735|NCT00905424|183320348|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.559|TWO_SIDED|90.0|-2.1|4.4||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||4.4|-2.1|0.5590
91714736|NCT00905424|183320348|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.2079|TWO_SIDED|90.0|-0.7|5.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||5.2|-0.7|0.2079
91714737|NCT00905424|183320349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1489|TWO_SIDED|90.0|-8.0|0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.5|-8.0|0.1489
91714738|NCT00905424|183320350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0852|TWO_SIDED|90.0|-2.8|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.8|0.0852
91714739|NCT00379899|183320357|SUPERIORITY_OR_OTHER|||||||0.073|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)||||||0.073
91714740|NCT00379899|183320358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.094||95.0|0.36|1.08|||Cochran-Mantel-Haenszel||Logit estimates (Cinacalcet:Control)|||1.08|0.36|0.094
91714741|NCT00379899|183320359|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.018
91792684|NCT01293799|183463097|OTHER|The association of factors associated with time to first peritonitis was analysed using the Cox proportional hazard regression model. Subjects were censored for various reasons to leave the study. Univariable Cox regression was used to identify factors associated with with time to first peritonitis episode.|Hazard Ratio (HR)|0.91||||0.56|TWO_SIDED|95.0|0.66|1.25||Unit of measure: Diabetic nephropathy as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Diabetic nephropathy as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression."||1.25|0.66|0.56
91792685|NCT01293799|183463098|OTHER||Hazard Ratio (HR)|1.05||||0.74|TWO_SIDED|95.0|0.78|1.42||Unit of measure: Glomerulonephritis as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Glomerulonephritis as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression."||1.42|0.78|0.74
91635775|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|3.48|||||TWO_SIDED|95.0|-3.11|10.06||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.06|-3.11|
91635776|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|-1.85|||||TWO_SIDED|95.0|-7.89|4.19||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||4.19|-7.89|
91635777|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|-0.15|||||TWO_SIDED|95.0|-4.53|4.23||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||4.23|-4.53|
91635778|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|-1.69|||||TWO_SIDED|95.0|-4.99|1.6||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||1.60|-4.99|
91635779|NCT02519777|183163872|SUPERIORITY||Difference in Percentage of Participants|6.36|||||TWO_SIDED|95.0|-2.7|15.42||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||15.42|-2.70|
91635780|NCT02519777|183163874|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 24 from baseline||||0.67
91669286|NCT03702816|183233172|OTHER|Linear Regression||||||0.55|||||||Regression, Linear|F=0.435||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.55
91635781|NCT02519777|183163874|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 48 from baseline||||0.78
91635782|NCT02519777|183163874|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 96 from baseline||||0.94
91635783|NCT02519777|183163874|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.42
91635784|NCT02519777|183163874|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.07
91635785|NCT02519777|183163874|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.37
91635786|NCT02519777|183163874|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.08
91635787|NCT02519777|183163874|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.33
91635788|NCT02519777|183163874|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.56
91635789|NCT02519777|183163876|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 24 from baseline||||0.63
91635790|NCT02519777|183163876|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 48 from baseline||||0.38
91635791|NCT02519777|183163876|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 96 from baseline||||0.95
91635792|NCT02519777|183163876|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.27
91669287|NCT03702816|183233172|OTHER|Linear Regression||||||0.43|||||||Regression, Linear|F=0.787||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.43
91669288|NCT03702816|183233172|OTHER|Linear Regression||||||0.036|||||||Regression, Linear|F=316.379||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.036
91714742|NCT00379899|183320361|SUPERIORITY_OR_OTHER|||||||0.258|||||||Cochran-Mantel-Haenszel|||||||0.258
91635793|NCT02519777|183163876|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.23
91714743|NCT00379899|183320362|SUPERIORITY_OR_OTHER|||||||0.011|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.011
91714744|NCT00379899|183320363|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
91635794|NCT02519777|183163876|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
91635795|NCT02519777|183163876|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.03
91635796|NCT02519777|183163876|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.02
91635797|NCT02519777|183163876|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
91635798|NCT02519777|183163877|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sCD14 in plasma at Week 48 from baseline||||1.00
91635799|NCT02519777|183163877|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.95
91635800|NCT02519777|183163877|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.96
91635801|NCT02519777|183163878|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||0.52
91635802|NCT02519777|183163878|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
91635803|NCT02519777|183163878|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
91635804|NCT02519777|183163879|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.91
91635805|NCT02519777|183163879|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.86
91635806|NCT02519777|183163879|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.94
91635807|NCT02519777|183163880|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 VCAM in plasma at Week 48 from baseline||||0.70
91635808|NCT02519777|183163880|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.28
91635809|NCT02519777|183163880|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.85
91635810|NCT02519777|183163881|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.99
91635811|NCT02519777|183163881|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.26
91669289|NCT03702816|183233172|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=2.032||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.39
91669290|NCT03702816|183233172|OTHER|Linear Regression||||||0.031|||||||Regression, Linear|F=425.337||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.031
91669291|NCT03702816|183233172|OTHER|Linear Regression||||||0.274|||||||Regression, Linear|F=4.739||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.274
91669292|NCT03702816|183233172|OTHER|Linear Regression||||||0.66|||||||Regression, Linear|F=0.263||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.66
91669293|NCT03702816|183233172|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=12.244||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.07
91669294|NCT03702816|183233172|OTHER|Linear Regression||||||0.48|||||||Regression, Linear|F=0.762||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.48
91669295|NCT03702816|183233172|OTHER|Linear Regression||||||0.12|||||||Regression, Linear|F=7.107||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.12
91669296|NCT03702816|183233173|OTHER|Linear Regression||||||0.85|||||||Regression, Linear|F=0.038||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.85
91714745|NCT00379899|183320364|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
91714746|NCT00379899|183320365|SUPERIORITY_OR_OTHER|||||||0.025|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.025
91714747|NCT00379899|183320366|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.021
91714748|NCT00379899|183320367|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
91669297|NCT03702816|183233173|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.042||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.84
91669298|NCT03702816|183233173|OTHER|Linear Regression||||||0.35|||||||Regression, Linear|F=1.021||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.35
91669299|NCT03702816|183233173|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.610||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.25
91669300|NCT03702816|183233173|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.779||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.25
91714749|NCT00379899|183320368|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
91714750|NCT01156805|183320386|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time||||||0.05
91714751|NCT01431339|183320390|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|-1.5||||||95.0|-7.4|4.6|||||Confidence intervals were adjusted for fever at baseline|||4.6|-7.4|
91525956|NCT03502616|182927256|SUPERIORITY||LS mean difference|3.61|STANDARD_ERROR_OF_MEAN|0.761|<|0.0001|TWO_SIDED|95.0|2.11|5.1|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.10|2.11|<0.0001
91669301|NCT03702816|183233173|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.455||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.54
91669302|NCT03702816|183233173|OTHER|Linear Regression||||||0.47|||||||Regression, Linear|F=0.650||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.47
91669303|NCT03702816|183233173|OTHER|Linear Regression||||||0.74|||||||Regression, Linear|F=0.131||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.74
91669304|NCT03702816|183233173|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.075||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
91669305|NCT03702816|183233173|OTHER|Linear Regression||||||0.41|||||||Regression, Linear|F=1.831||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.41
91669306|NCT03702816|183233173|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.079||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
91669307|NCT03702816|183233173|OTHER|Linear Regression||||||0.52|||||||Regression, Linear|F=0.879||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.52
91669308|NCT03702816|183233173|OTHER|Linear Regression||||||0.98|||||||Regression, Linear|F=0.001||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.98
91714752|NCT00520039|183320523|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.09|STANDARD_ERROR_OF_MEAN|0.94||0.02|TWO_SIDED|95.0|0.15|2.03|||Chi-squared|df = 1|The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.|Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.||2.03|0.15|0.02
91714753|NCT00520039|183320524|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|1.31||0.32|TWO_SIDED|95.0|-1.0|1.62|||Chi-squared|df = 1|The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio|||1.62|-1.00|0.32
91714754|NCT00520039|183320525|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.25|STANDARD_ERROR_OF_MEAN|1.03||0.31|TWO_SIDED|95.0|-0.78|1.28|||Chi-squared|df = 1||||1.28|-0.78|.31
91714755|NCT02493517|183320537|NON_INFERIORITY|The non-inferiority margin is defined as 0.6 SDS for the upper limit of 95% CI of the LS mean difference of the log-transformed IGF-1 SDS without back-transformation.|Treatment difference|-0.32|||||TWO_SIDED|95.0|-0.74|0.11||||||"The Least Square (LS) Means and 95% Confidence Intervals (CIs) were based on the generalised linear model (GLM) with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The treatment difference (lanreotide Autogel - lanreotide PR) is presented."||0.11|-0.74|
91714756|NCT02493517|183320537|NON_INFERIORITY|The non-inferiority margin for the back-transformed LS Mean ratio of IGF-1 SDS of lanreotide Autogel versus lanreotide PR is exp (0.6) = 1.822.|LS Mean ratio|0.73|||||TWO_SIDED|95.0|0.48|1.11||||||"The LS Means and 95% CIs were based on the GLM with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The LS Mean ratio (lanreotide Autogel versus lanreotide PR) is presented."||1.11|0.48|
91714757|NCT02493517|183320538|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-5.2|17.7||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of normal IGF-1 SDS values at EOST/EW Visit is presented.||17.7|-5.2|
91714758|NCT02493517|183320539|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-17.5|14.4||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤2.5 mcg/L at EOST/EW Visit is presented.||14.4|-17.5|
91714759|NCT02493517|183320540|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-8.9|12.0||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤1 mcg/L at EOST/EW Visit is presented.||12.0|-8.9|
91635812|NCT02519777|183163881|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.20
91635813|NCT02519777|183163882|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.59
91635814|NCT02519777|183163882|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.39
91635815|NCT02519777|183163882|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.80
91635816|NCT02519777|183163883|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.90
91635817|NCT02519777|183163883|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.14
91635818|NCT02519777|183163883|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.49
91635819|NCT02519777|183163884|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 NFL in CSF at Week 48 from baseline||||0.52
91635820|NCT02519777|183163884|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.99
91635821|NCT02519777|183163884|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.54
91635822|NCT00256204|183163890|SUPERIORITY_OR_OTHER|||||||0.0133|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 1mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start) and 2mg (delayed-start)are combined to one placebo group."||||0.0133
91635823|NCT00256204|183163890|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 2mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start)and 2mg (delayed-start) are combined to one placebo group."||||0.0001
91635824|NCT00256204|183163890|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center .|Repeated Measures|||Hypothesis #2: Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set).||||0.0250
91635825|NCT00256204|183163890|SUPERIORITY_OR_OTHER|||||||0.6028||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center|Repeated Measures|||Hypothesis #2:Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set.)||||0.6028
91635826|NCT00256204|183163890|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 1mg early-start group and the 1mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.0||||||90.0|-0.036|0.036||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.036|-0.036|
91635827|NCT00256204|183163890|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 2mg early-start group and the 2mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.029||||||90.0|-0.005|0.062||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.062|-0.005|
91669309|NCT03702816|183233173|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.95
91669310|NCT03702816|183233173|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=1.733||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.32
91635828|NCT00256204|183163891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.005|||<|0.0001||95.0|-3.857|-2.153|||ANCOVA|||The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates. For this analysis, both delayed start arms are pooled as a 'placebo arm'||-2.153|-3.857|<0.0001
91635829|NCT00256204|183163891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.154|||<|0.0001||95.0|-4.004|-2.305|||ANCOVA|||"The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates.~For this analysis, both delayed start arms are pooled as a 'placebo arm'"||-2.305|-4.004|<0.0001
91635830|NCT02074436|183163896|OTHER|||||||0.5|TWO_SIDED|0.001|||||Fisher Exact|||The results are from the first and only interim analysis focusing on the primary endpoint: proportion of patient with major bleeding (Grade 3 and 4) during the study. The interim analysis was performed after 11 patients in each arm were randomized and results were obtained. One-sided fisher's exact test was employed in the analysis. The null hypothesis is the probability of occurring major bleeding is the same for Arm A and Arm B||||0.5
91635831|NCT03490734|183163901|SUPERIORITY|||||||0.52||||||Corrected for multiple comparisons by using the threshold free cluster enhancement, nonparametric thresholding algorithm in FMRIB Software Library (FSL), resulting in a family-wise error rate (FWE) corrected significance threshold of p-FWE\<0.05|ANCOVA|||Whole-brain analyses were used. No clusters of significant activation were detected.||||0.52
91635832|NCT03490734|183163902|SUPERIORITY|||||||0.016||||||Corrected for multiple comparisons by using the threshold free cluster enhancement (TFCE), nonparametric thresholding algorithm in FSL, resulting in a family-wise error rate corrected significance threshold of p-FWE \< 0.05|ANCOVA|||||||0.016
91635833|NCT00792922|183163918|SUPERIORITY|Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm \& parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % \& 97.5 % percentiles were reported.|Mean Difference (Final Values)|1.4||||0.22|TWO_SIDED|95.0|-1.0|3.8|||Regression, Linear|||"This is analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||3.8|-1|0.22
91635834|NCT00792922|183163918|SUPERIORITY|For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.|Mean Difference (Final Values)|2.6||||0.73|TWO_SIDED|95.0|-0.3|5.3|||Ordinary least squares linear regression|||"This is the analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.~Here we are looking at the prevalence of trachoma"||5.3|-0.3|0.73
91635835|NCT00792922|183163918|SUPERIORITY||Median Difference (Final Values)|-4.6||||0.2|TWO_SIDED|95.0|-11.1|1.9|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||1.9|-11.1|0.20
91635836|NCT00792922|183163918|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6|TWO_SIDED|95.0|-7.7|12.5|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma."||12.5|-7.7|0.60
91635837|NCT04491591|183163920|SUPERIORITY|||||||0.801|||||||Kruskal-Wallis|||||||0.801
91635838|NCT04491591|183163921|SUPERIORITY|||||||0.1336|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.1336
91635839|NCT04491591|183163921|SUPERIORITY|Immediate reconstruction versus delayed reconstruction||||||0.5505|||||||Fisher Exact|||||||0.5505
91635840|NCT04491591|183163921|SUPERIORITY|||||||0.6178|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.6178
91635841|NCT04491591|183163922|SUPERIORITY|||||||0.2317|||||||Fisher Exact|||||||0.2317
91635842|NCT04491591|183163923|SUPERIORITY|||||||0.1052|||||||Fisher Exact|||||||0.1052
91635843|NCT04491591|183163924|OTHER||||||||||||||||||Within subjects pre/post comparison|||
91635844|NCT04491591|183163925|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91635845|NCT04491591|183163927|OTHER||||||||||||||||||Descriptive analysis using mean and standard deviation|||
91635846|NCT04491591|183163928|SUPERIORITY|||||||0.0302|||||||Kruskal-Wallis|||||||0.0302
91635847|NCT04491591|183163929|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.135
91635848|NCT04491591|183163929|SUPERIORITY|||||||0.51|||||||Fisher Exact|||Immediate reconstruction versus delayed reconstruction||||0.510
91635849|NCT04491591|183163929|SUPERIORITY|||||||0.469|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.469
91635850|NCT04491591|183163930|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
91635851|NCT04491591|183163931|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
91635852|NCT04111185|183163948|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91635853|NCT01277666|183163980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.546|TWO_SIDED|95.0|-6.1|11.0|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg once daily||11.0|-6.1|0.546
91635854|NCT01277666|183163980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.648|TWO_SIDED|95.0|-6.5|10.7|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg twice daily||10.7|-6.5|0.648
91792686|NCT01293799|183463099|OTHER||Hazard Ratio (HR)|1.25||||0.42|TWO_SIDED|95.0|0.73|2.15||Unit of measure: Tubulointerstitial nephritis as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Tubulointerstitial Nephritis as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression."||2.15|0.73|0.42
91635855|NCT01277666|183163981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.592|TWO_SIDED|95.0|-8.8|4.8|||Mantel Haenszel|||||4.8|-8.8|0.592
91635856|NCT01277666|183163981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.475|TWO_SIDED|95.0|-9.2|4.4|||Mantel Haenszel|||||4.4|-9.2|0.475
91635857|NCT01277666|183163982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.415|TWO_SIDED|95.0|-4.4|10.3|||Mantel Haenszel|||||10.3|-4.4|0.415
91635858|NCT01277666|183163982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.354|TWO_SIDED|95.0|-3.9|10.9|||Mantel Haenszel|||||10.9|-3.9|0.354
91635859|NCT01277666|183163983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-5.2|5.2|||Mantel Haenszel|||||5.2|-5.2|0.985
91635860|NCT01277666|183163983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.709|TWO_SIDED|95.0|-6.1|4.1|||Mantel Haenszel|||||4.1|-6.1|0.709
91635861|NCT01277666|183163984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.633|TWO_SIDED|95.0|-6.5|10.4|||Mantel Haenszel|||||10.4|-6.5|0.633
91635862|NCT01277666|183163984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.889|TWO_SIDED|95.0|-7.8|9.0|||Mantel Haenszel|||||9.0|-7.8|0.889
91635863|NCT01277666|183163985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.541|TWO_SIDED|95.0|-8.1|4.2|||Mantel Haenszel|||||4.2|-8.1|0.541
91635864|NCT01277666|183163985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.43|TWO_SIDED|95.0|-8.5|3.7|||Mantel Haenszel|||||3.7|-8.5|0.430
91635865|NCT01277666|183163986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|2.426||0.642|TWO_SIDED|95.0|-5.89|3.64||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||3.64|-5.89|0.642
91635866|NCT01277666|183163986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|2.652||0.898|TWO_SIDED|95.0|-5.55|4.87||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||4.87|-5.55|0.898
91635867|NCT01277666|183163986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.37|STANDARD_ERROR_OF_MEAN|2.467||0.173|TWO_SIDED|95.0|-1.48|8.21||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||8.21|-1.48|0.173
91635868|NCT01277666|183163986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|2.697||0.493|TWO_SIDED|95.0|-3.45|7.15||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||7.15|-3.45|0.493
91635869|NCT01657903|183163997|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.15|||<|0.0001|TWO_SIDED|95.0|34.42|47.89||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.89|34.42|<0.0001
91635870|NCT01657903|183163997|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.28|||<|0.0001|TWO_SIDED|95.0|34.51|48.06||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||48.06|34.51|<0.0001
91635871|NCT01657903|183163997|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|40.83|||<|0.0001|TWO_SIDED|95.0|34.06|47.61||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.61|34.06|<0.0001
91635872|NCT01657903|183163998|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.36|||<|0.0001|TWO_SIDED|95.0|6.01|12.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.72|6.01|<0.0001
91635873|NCT01657903|183163998|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.45|||<|0.0001|TWO_SIDED|95.0|6.07|12.82||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.82|6.07|<0.0001
91669311|NCT03702816|183233173|OTHER|Linear Regression||||||0.67|||||||Regression, Linear|F=0.249||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.67
91669312|NCT03702816|183233174|OTHER|Linear Regression||||||0.76|||||||Regression, Linear|F=0.098||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in Control Subjects||||0.76
91669313|NCT03702816|183233174|OTHER|Linear Regression||||||0.49|||||||Regression, Linear|F=0.513||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in Control Subjects||||0.49
91669314|NCT03702816|183233174|OTHER|Linear Regression||||||0.93|||||||Regression, Linear|F=0.008||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.93
91635874|NCT01657903|183163998|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|8.28|15.03||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.03|8.28|<0.0001
91635875|NCT02312934|183164013|OTHER||||||=|0.41||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||=0.41
91635876|NCT02312934|183164014|OTHER|||||||0.79||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||0.79
91635877|NCT03395704|183164021|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||< 0.0001
91635878|NCT01801189|183164025|SUPERIORITY|||||||0.1||||||Threshold for significance was P \<0.05.|t-test, 1 sided|||||||0.10
91635879|NCT01801189|183164025|SUPERIORITY|||||||0.23||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 1||||.23
91635880|NCT01801189|183164025|SUPERIORITY|||||||0.31||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 2||||.31
91635881|NCT00498706|183164027|SUPERIORITY_OR_OTHER||t value|-2.95||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91635882|NCT00498706|183164028|SUPERIORITY_OR_OTHER||Chi-square|5.83||||0.02||95.0|||||Chi-squared|||||||0.02
91635883|NCT00498706|183164028|SUPERIORITY_OR_OTHER||Chi-square|7.75||||0.006||95.0|||||Chi-squared||Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.|||||.006
91635884|NCT00498706|183164030|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|-0.09|STANDARD_DEVIATION|1.26||0.89|TWO_SIDED|95.0|-1.35|1.17|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||1.17|-1.35|0.89
91635885|NCT00498706|183164031|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|1.07|STANDARD_DEVIATION|1.695||0.22|TWO_SIDED|95.0|-0.63|2.76|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||2.76|-0.63|0.22
91635886|NCT04524663|183164032|SUPERIORITY||Median Difference (Net)|0.59||||0.89|TWO_SIDED|95.0|-8.14|9.32|||Regression, Linear|||||9.32|-8.14|0.89
91635887|NCT04524663|183164033|SUPERIORITY||Median Difference (Net)|18.9||||0.02|TWO_SIDED|95.0|2.98|34.83|||Regression, Linear|||||34.83|2.98|0.02
91635888|NCT04524663|183164034|SUPERIORITY||Hazard Ratio (HR)|1.69||||0.24|TWO_SIDED|95.0|0.7|4.1|||Cox proportional hazards model|||||4.10|0.70|0.24
91635889|NCT04524663|183164035|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91635890|NCT04524663|183164036|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.24|TWO_SIDED|95.0|0.32|1.33|||Cox proportional hazards model|||||1.33|0.32|0.24
91635891|NCT00911508|183164039|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.65|1.15||||||||1.15|0.65|
91635892|NCT00911508|183164040|SUPERIORITY||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
91635893|NCT00911508|183164041|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.74|0.93||||||||0.93|0.74|
91635894|NCT00911508|183164042|SUPERIORITY||Cox Proportional Hazard|0.88|||||TWO_SIDED|95.0|0.72|1.09||||||||1.09|0.72|
91635895|NCT00911508|183164043|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.53|1.68||||||||1.68|0.53|
91635896|NCT00911508|183164044|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.51|1.51||||||||1.51|0.51|
91635897|NCT00911508|183164045|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.33|1.72||||||||1.72|0.33|
91635898|NCT00911508|183164046|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.41|3.09||||||||3.09|0.41|
91635899|NCT00911508|183164047|SUPERIORITY||Cox Proportional Hazard|0.52|||||TWO_SIDED|95.0|0.45|0.6||||||||0.60|0.45|
91635900|NCT00911508|183164048|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.77|0.97||||||||0.97|0.77|
91635901|NCT00911508|183164049|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|3.7|6.9|||Mixed Models Analysis|||12 Month||6.9|3.7|<0.001
91635902|NCT00911508|183164049|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||5 Years||4.8|2.1|<0.001
91635903|NCT00911508|183164050|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.3|-1.2|||Mixed Models Analysis|||12 Month||-1.2|-2.3|0.001
91635904|NCT00911508|183164050|SUPERIORITY||Mean Difference (Net)|-1.4||||0.001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||5 Year||-0.9|-1.9|0.001
91635905|NCT00911508|183164051|SUPERIORITY||Mean Difference (Net)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.0|-1.1|||Mixed Models Analysis|||12 Month||-1.1|-2.0|<0.001
91635906|NCT00911508|183164051|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||5 Year||-0.4|-1.7|<0.001
91635907|NCT04308668|183164053|SUPERIORITY||Mean Difference (Net)|-2.4||||0.35|TWO_SIDED|95.0|-7.0|2.2|||Fisher Exact||Values represent percentages. Experimental treatment arm compared with the placebo control arm.|||2.2|-7.0|0.35
91635908|NCT04308668|183164054|SUPERIORITY||Mean Difference (Net)|-0.27||||0.117|TWO_SIDED|95.0|-0.61|0.27|||Mixed Models Analysis|||||0.27|-0.61|0.117
91635909|NCT01266967|183164062|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||<|0.0001|TWO_SIDED|95.0|29.3|52.6|||Exact Test||The estimated value represents the percentage of participants with OIR.|||52.6|29.3|<0.0001
91635910|NCT01266967|183164062|SUPERIORITY_OR_OTHER||percentage of participants|37.0|||<|0.0001|TWO_SIDED|95.0|25.3|49.8|||Exact Test||The estimated value represents the percentage of participants with OIR.|||49.8|25.3|<0.0001
91635911|NCT01519700|183164084|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)|Mean Difference (Net)|0.04|||||ONE_SIDED|97.5|-0.26||||||The one-sided 97.5% Confidence Interval: \[-0.26, ∞).||||-0.26|
91635912|NCT05111548|183164091|SUPERIORITY|||||||0.923|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.923
91635913|NCT05111548|183164092|SUPERIORITY|||||||0.11|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.110
91635914|NCT05111548|183164093|SUPERIORITY|||||||0.818|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.818
91635915|NCT05111548|183164094|SUPERIORITY|||||||0.13|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.130
91635916|NCT03938857|183164104|OTHER||Slope|-0.1088295|STANDARD_ERROR_OF_MEAN|0.4728041||0.814|TWO_SIDED|95.0|-1.035508|0.8178494|||Mixed Models Analysis||Estimated value represents interaction between treatment and days.|Placebo group compared to combined Dexmedetomidine groups.||0.8178494|-1.035508|0.814
91635917|NCT01729559|183164132|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on a previous trial showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of unfractionated heparin (UFH) every 12 hr. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required.|Risk Difference (RD)|6.5||||0.025|TWO_SIDED|95.0|-2.9|15.8||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|Analysis was performed in a subset of patients who received at least one follow-up venous duplex ultrasound of the lower extremities.||15.8|-2.9|0.025
91635918|NCT01729559|183164132|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on these data showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of UFH every 12 hours. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required. This analysis was performed in the entire sample.|Risk Difference (RD)|3.1||||0.025|TWO_SIDED|95.0|-1.6|7.7||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|"Analysis was performed in the total sample of eligible patients and who received their assigned treatment (referred to as the randomized treated sample) ."||7.7|-1.6|0.025
91635919|NCT01453439|183164150|SUPERIORITY||Slope|-0.4602|STANDARD_ERROR_OF_MEAN|0.1249|<|0.01|TWO_SIDED|||||Degrees of freedom=90.9|Mixed Models Analysis|Effect of interest: time by group interaction|The estimated value describes the mean slope difference of CBT compared to SPT.|"We compared the difference in the rate of change in BDD symptom severity over time (during treatment phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||<.01
91635920|NCT01453439|183164150|SUPERIORITY||Slope|-0.00984|STANDARD_ERROR_OF_MEAN|0.1038||0.62|TWO_SIDED|||||Degrees of freedom=74.7|Mixed Models Analysis|The effect of interest was the time by group interaction.|The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50).|"We compared the difference in the rate of change in BDD symptom severity over time (during the follow-up phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity during follow-up will not differ significantly between CBT and SPT treatments \[to be tested\]."||||.62
91635921|NCT01453439|183164151|SUPERIORITY|||||||0.1||||||Degrees of freedom=93.2|Mixed Models Analysis|||"We compared the change in Patient Insight over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.10
91635922|NCT01453439|183164151|SUPERIORITY|||||||0.45||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in Patient Insight over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.45
91635923|NCT01453439|183164152|SUPERIORITY|||||||0.05||||||Degrees of freedom=89.1|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in depressive symptoms in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.05
91635924|NCT01453439|183164152|SUPERIORITY|||||||0.26||||||Degrees of freedom=63.7|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depressive symptoms in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.26
91714760|NCT02493517|183320541|OTHER||Risk Difference (RD)|4.7|||||TWO_SIDED|95.0|-3.1|12.5||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage subjects with normal IGF-1 levels and who have GH levels \>1 mcg/L and ≤2.5 mcg/L at EOST/EW Visit is presented.||12.5|-3.1|
91714761|NCT02493517|183320542|OTHER||Treatment difference|3.63|STANDARD_DEVIATION|21.6|||TWO_SIDED|95.0|-3.98|11.25||||||Treatment difference (lanreotide Autogel - lanreotide PR) is presented.||11.25|-3.98|
91635925|NCT01453439|183164153|SUPERIORITY|||||||0.04||||||Degrees of freedom=91.4|Mixed Models Analysis|||"We compared the change in Quality of life satisfaction over time (During treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Quality of life satisfaction severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.04
91635926|NCT01453439|183164153|SUPERIORITY|||||||0.82||||||Degrees of freedom=74.7|Mixed Models Analysis|||"We compared the change in the quality of life satisfaction over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in the quality of life satisfaction in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.82
91635927|NCT01453439|183164154|SUPERIORITY||Mean Difference (Net)|0.7937|STANDARD_ERROR_OF_MEAN|0.3007||0.0095|TWO_SIDED|||||Effect of interest: Treatment main effect, two-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment: F(num df=1, den df=112) = 5.17|Least Squares Means difference|Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.||||0.0095
91635928|NCT01453439|183164158|SUPERIORITY|||||||0.3||||||Degrees of freedom=88.0|Mixed Models Analysis|||"We compared the change in social functioning over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts, and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.30
91669315|NCT03702816|183233174|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.430||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.54
91669316|NCT03702816|183233174|OTHER|Linear Regression||||||0.77|||||||Regression, Linear|F=0.142||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in AD Subjects||||0.77
91669317|NCT03702816|183233174|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.496||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in AD Subjects||||0.61
91669318|NCT03702816|183233174|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=8.046||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in PD Subjects||||0.11
91669319|NCT03702816|183233174|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.051||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in PD Subjects||||0.84
91669320|NCT02522780|183233223|SUPERIORITY||Odds Ratio (OR)|1.57|||>|0.05|TWO_SIDED|95.0|0.96|2.54||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||2.54|0.96|>0.05
91669321|NCT02522780|183233224|SUPERIORITY||Odds Ratio (OR)|1.24|||>|0.05|TWO_SIDED|95.0|0.76|2.03||The p-value was based on Generalized estimating equations (GEE) approach with binary outcomes (clinical remission) and an unstructured working correlation matrix, at a 0.05 significance level.|Generalised estimating equation approach|||Proportions were compared between treatment groups over 6 months.||2.03|0.76|>0.05
91669322|NCT02522780|183233225|SUPERIORITY||Hazard Ratio (HR)|0.6|||>|0.05|TWO_SIDED|95.0|0.25|1.44||The p-value was based on log-rank test using pathway of randomization as the stratification factor, at a 0.05 significance level.|Log Rank|||Times to relapse were compared between treatment groups up to 6 months.||1.44|0.25|>0.05
91669323|NCT02522780|183233226|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.05|TWO_SIDED|95.0|0.19|0.79||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||0.79|0.19|<0.05
91669324|NCT02522780|183233227|SUPERIORITY||Mean difference|-1.0|||>|0.05|TWO_SIDED|95.0|-2.7|0.7||The p-value was based on a repeated-measures analysis of covariance (ANCOVA) model with an unstructured correlation matrix , at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in CRP levels over 6 months was reported.||0.7|-2.7|>0.05
91669325|NCT02522780|183233228|SUPERIORITY||Mean difference|-66.92|||>|0.05|TWO_SIDED|95.0|-140.2|6.36||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in fecal calprotectin levels over 6 months was reported.||6.36|-140.2|>0.05
91669326|NCT02522780|183233229|SUPERIORITY||Mean difference|-0.32|||>|0.05|TWO_SIDED|95.0|-4.41|3.77||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in IBDQ total scores over 6 months was reported.||3.77|-4.41|>0.05
91669327|NCT00926367|183233235|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.||||||>0.05
91669328|NCT00926367|183233237|SUPERIORITY_OR_OTHER||||||>|0.05||||||A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|Dunn's Multiple Comparisons Test|||||||>0.05
91669329|NCT00860262|183233257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-12.9|-8.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus Telmisartan 80 mg|||-8.3|-12.9|<0.0001
91669330|NCT00860262|183233257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.18||0.0002|TWO_SIDED|95.0|-6.7|-2.1|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.1|-6.7|0.0002
91669331|NCT00860262|183233258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-13.1|-8.2|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-8.2|-13.1|<0.0001
91635929|NCT01453439|183164158|SUPERIORITY|||||||0.85||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in social functioning over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.85
91635930|NCT01453439|183164159|SUPERIORITY||Mean Difference (Net)|1.5867|STANDARD_ERROR_OF_MEAN|0.6882||0.0235|TWO_SIDED|||||a priori significance level: 2-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment - F(num def=1,den df=79.9) = 15.55|Least Squares Means difference|Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.||||0.0235
91635931|NCT01453439|183164160|SUPERIORITY||Median Difference (Net)|9.439|STANDARD_ERROR_OF_MEAN|3.4259||0.0069|TWO_SIDED|||||a priori significance level: 2-sided alpha=0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment group, site, time (repeated)) effect of interest: main effect of treatment: F(num df=1, den df=110) = 7.59|Least Squares Mean difference|Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.||||0.0069
91635932|NCT01014442|183164161|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.305||||0.2649|TWO_SIDED|95.0|-0.83|4.25|||Wilcoxon rank sum test|||Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2500|-0.8300|0.2649
91635933|NCT01014442|183164161|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.405||||0.3113|TWO_SIDED|95.0|-10.2|42.78|||Wilcoxon rank sum test|||Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||42.7800|-10.2000|0.3113
91635934|NCT01014442|183164161|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.305||||0.2953|TWO_SIDED|95.0|-0.81|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.8100|0.2953
91635935|NCT01014442|183164162|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.29||||0.1308|TWO_SIDED|95.0|-2.99|0.41|||Wilcoxon rank sum test|||Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4100|-2.9900|0.1308
91635936|NCT01014442|183164162|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-10.845||||0.4886|TWO_SIDED|95.0|-31.5|20.79|||Wilcoxon rank sum test|||Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||20.7900|-31.5000|0.4886
91635937|NCT01014442|183164162|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.2218|TWO_SIDED|95.0|-0.6|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.6000|0.2218
91635938|NCT01014442|183164163|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.87||||0.0886|TWO_SIDED|95.0|-3.79|0.28|||Wilcoxon rank sum test|||Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-3.7900|0.0886
91635939|NCT01014442|183164163|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-30.76||||0.022|TWO_SIDED|95.0|-54.97|-6.36|||Wilcoxon rank sum test|||Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-6.3600|-54.9700|0.0220
91635940|NCT01014442|183164163|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.56||||0.0008|TWO_SIDED|95.0|-1.02|-0.27|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.2700|-1.0200|0.0008
91635941|NCT01014442|183164164|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|3.945||||0.0318|TWO_SIDED|95.0|0.25|8.23|||Wilcoxon rank sum test|||Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.2300|0.2500|0.0318
91635942|NCT01014442|183164164|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-7.59||||0.7144|TWO_SIDED|95.0|-51.19|30.7|||Wilcoxon rank sum test|||Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.7000|-51.1900|0.7144
91635943|NCT01014442|183164164|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.27||||0.393|TWO_SIDED|95.0|-0.31|0.88|||Wilcoxon rank sum test|||Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.8800|-0.3100|0.3930
91635944|NCT01014442|183164165|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|17.08||||0.3002|TWO_SIDED|95.0|-16.5|74.32|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||74.3200|-16.5000|0.3002
91714762|NCT02493517|183320543|OTHER||Risk Difference (RD)|-5.5|||||TWO_SIDED|95.0|-24.3|13.3||||||Risk difference (lanreotide Autogel - lanreotide PR) in the percentage of subjects with at least 20% reduction in the solid component of tumour volume compared to Baseline is presented.||13.3|-24.3|
91635945|NCT01014442|183164166|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-25.24||||0.0334|TWO_SIDED|95.0|-53.25|-2.29|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.2900|-53.2500|0.0334
91635946|NCT01014442|183164167|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-23.805||||0.1151|TWO_SIDED|95.0|-52.27|5.97|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.9700|-52.2700|0.1151
91635947|NCT01014442|183164168|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-15.63||||0.5974|TWO_SIDED|95.0|-63.88|30.56|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.5600|-63.8800|0.5974
91635948|NCT01014442|183164169|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0005||||0.5466|TWO_SIDED|95.0|-0.00103|0.00259|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00259|-0.00103|0.5466
91635949|NCT01014442|183164169|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00728||||0.3223|TWO_SIDED|95.0|-0.00707|0.03161|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.03161|-0.00707|0.3223
91635950|NCT01014442|183164169|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00026||||0.2108|TWO_SIDED|95.0|-0.0007|0.00012|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00012|-0.00070|0.2108
91635951|NCT01014442|183164169|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000112||||0.4334|TWO_SIDED|95.0|-0.000014|0.0000462|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator.||0.0000462|-0.0000140|0.4334
91635952|NCT01014442|183164170|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00081||||0.1511|TWO_SIDED|95.0|-0.00216|0.0003|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00030|-0.00216|0.1511
91635953|NCT01014442|183164170|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00695||||0.4131|TWO_SIDED|95.0|-0.0205|0.01103|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01103|-0.02050|0.4131
91635954|NCT01014442|183164170|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00017||||0.2677|TWO_SIDED|95.0|-0.00046|0.00013|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00046|0.2677
91635955|NCT01014442|183164170|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000185||||0.0173|TWO_SIDED|95.0|-0.0000394|-0.000005|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000050|-0.0000394|0.0173
91635956|NCT01014442|183164171|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00063||||0.3784|TWO_SIDED|95.0|-0.0023|0.00084|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00084|-0.00230|0.3784
91635957|NCT01014442|183164171|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.01602||||0.0942|TWO_SIDED|95.0|-0.03229|0.00297|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00297|-0.03229|0.0942
91669332|NCT00860262|183233258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.3|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.3|0.0001
91669333|NCT00860262|183233259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-12.6|-7.7|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-7.7|-12.6|<0.0001
91669334|NCT00860262|183233259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.2|0.0001
91669335|NCT00860262|183233260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-10.2|-5.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-5.4|-10.2|<0.0001
91669336|NCT00860262|183233260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.0|-2.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.3|-7.0|0.0001
91525957|NCT03502616|182927256|SUPERIORITY||LS mean difference|5.42|STANDARD_ERROR_OF_MEAN|0.902|<|0.0001|TWO_SIDED|95.0|3.65|7.2|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.20|3.65|<0.0001
91525958|NCT03502616|182927256|SUPERIORITY||LS mean difference|5.01|STANDARD_ERROR_OF_MEAN|0.943|<|0.0001|TWO_SIDED|95.0|3.15|6.86|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.86|3.15|<0.0001
91635958|NCT01014442|183164171|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00037||||0.0032|TWO_SIDED|95.0|-0.00062|-0.00015|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00015|-0.00062|0.0032
91635959|NCT01014442|183164171|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000126||||0.176|TWO_SIDED|95.0|-0.0000328|-0.0000091|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000091|-0.0000328|0.1760
91635960|NCT01014442|183164172|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0043||||0.0509|TWO_SIDED|95.0|-0.00027|0.00833|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00833|-0.00027|0.0509
91635961|NCT01014442|183164172|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00567||||0.8262|TWO_SIDED|95.0|-0.03414|0.02671|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.02671|-0.03414|0.8262
91635962|NCT01014442|183164172|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00023||||0.4345|TWO_SIDED|95.0|-0.0003|0.0007|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00070|-0.00030|0.4345
91635963|NCT01014442|183164172|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.6472|TWO_SIDED|95.0|-0.0000586|0.0000364|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000364|-0.0000586|0.6472
91635964|NCT01014442|183164173|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.5745|TWO_SIDED|95.0|-1.95|0.5|||Wilcoxon rank sum test|||Tmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-1.9500|0.5745
91635965|NCT01014442|183164173|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8||||0.2003|TWO_SIDED|95.0|-2.3333|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.3333|0.2003
91635966|NCT01014442|183164173|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.5||||0.0929|TWO_SIDED|95.0|-2.0833|0.0|||Wilcoxon rank sum test|||Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.0833|0.0929
91635967|NCT01014442|183164173|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.0823|TWO_SIDED|95.0|0.0|0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0667|0.0000|0.0823
91635968|NCT01014442|183164174|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0417||||0.8106|TWO_SIDED|95.0|-0.5|1.7333|||Wilcoxon rank sum test|||Tmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.7333|-0.5000|0.8106
91669337|NCT00860262|183233261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-4.0|-8.8|<0.0001
91669338|NCT00860262|183233261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.23||0.0077|TWO_SIDED|95.0|-5.7|-0.9|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-0.9|-5.7|0.0077
91669339|NCT00420095|183233300|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.~Pre-defined non-inferiority margin of 0.3%."|Mean Difference (Net)|-0.05||||0.497||95.0|-0.2|0.1|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.||Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.||0.10|-0.20|0.497
91669340|NCT00420095|183233301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.497||95.0|-0.1|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.10|0.497
91669341|NCT00420095|183233302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.419||95.0|-0.48|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.48|0.419
91669342|NCT00420095|183233303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.741||95.0|-1.09|0.78||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.78|-1.09|0.741
91635969|NCT01014442|183164174|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-0.1667|0.1667|||Wilcoxon rank sum test|||Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1667|-0.1667|1.0000
91635970|NCT01014442|183164174|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0667||||0.6311|TWO_SIDED|95.0|-0.3333|1.4667|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.4667|-0.3333|0.6311
91635971|NCT01014442|183164174|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.433|TWO_SIDED|95.0|-0.1667|0.0167|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0167|-0.1667|0.4330
91635972|NCT01014442|183164175|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-1.1667|0.5833|||Wilcoxon rank sum test|||Tmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5833|-1.1667|1.0000
91635973|NCT01014442|183164175|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0833||||0.4947|TWO_SIDED|95.0|-2.0|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.0000|0.4947
91635974|NCT01014442|183164175|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1667||||0.4425|TWO_SIDED|95.0|-1.9667|0.2|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2000|-1.9667|0.4425
91635975|NCT01014442|183164175|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.972|TWO_SIDED|95.0|-0.05|0.0333|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0333|-0.0500|0.9720
91635976|NCT01014442|183164176|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.8834|TWO_SIDED|95.0|-1.1667|0.7|||Wilcoxon rank sum test|||Tmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.7000|-1.1667|0.8834
91635977|NCT01014442|183164176|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8333||||0.0386|TWO_SIDED|95.0|-2.2|0.0|||Wilcoxon rank sum test|||Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.2000|0.0386
91635978|NCT01014442|183164176|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.525||||0.0558|TWO_SIDED|95.0|-2.6167|0.0|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.6167|0.0558
91669343|NCT00420095|183233304|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||P-value for the HbA1c Percentage Criteria (7%)|Fisher Exact|||||||0.644
91669344|NCT00420095|183233304|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||P-value for the HbA1c Percentage Criteria (6.5%)|Fisher Exact|||||||0.672
91669345|NCT00420095|183233306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.67||95.0|-0.16|0.11||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.11|-0.16|0.670
91669346|NCT00393705|183233307|SUPERIORITY_OR_OTHER|||||||0.2519||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.2519
91669347|NCT00393705|183233308|SUPERIORITY_OR_OTHER|||||||0.0287||95.0||||P-value for HbA1c \<7%. Additional statistically significant terms from the model below were baseline HbA1c and treatment by lead-in interaction.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0287
91669348|NCT00393705|183233308|SUPERIORITY_OR_OTHER|||||||0.0471||95.0||||P-value for HbA1c ≤6.5%. Additional statistically significant term from the model below was baseline HbA1c.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0471
91669349|NCT00393705|183233310|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
91669350|NCT00393705|183233311|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0002
91669351|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||P-value for Fasting.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0129
91669352|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for 2-Hours After Breakfast.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0027
91669353|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.1947||95.0||||P-value for Pre-Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1947
91669354|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.0077||95.0||||P-value for 2-Hours After Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
91669355|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.1885||95.0||||P-value for Pre-Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1885
91714763|NCT03718429|183320548|SUPERIORITY|In line with recommendations for pilot investigations, since there were no preliminary data exploring the pharmacodynamic effects of vascular dose rivaroxaban in addition to antiplatelet therapy, we arbitrarily chose a sample size of 20 patients per treatment cohort.||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
91714764|NCT03718429|183320549|SUPERIORITY|||||||0.488|||||||Wilcoxon (Mann-Whitney)|||||||0.488
91714765|NCT03718429|183320550|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91714766|NCT05404711|183320553|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
91714767|NCT05404711|183320554|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
91714768|NCT05404711|183320555|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
91714769|NCT05404711|183320556|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
91714770|NCT05404711|183320557|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
91714771|NCT05404711|183320558|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
91714772|NCT05404711|183320559|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
91669356|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.5525||95.0||||P-value for 2-Hours After Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.5525
91669357|NCT00393705|183233312|SUPERIORITY_OR_OTHER|||||||0.4994||95.0||||P-value for 3:00 A.M.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.4994
91669358|NCT00393705|183233314|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value for Total Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.7230
91669359|NCT00393705|183233314|SUPERIORITY_OR_OTHER|||||||0.0063||95.0||||P-value for Nocturnal Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0063
91669360|NCT00393705|183233314|SUPERIORITY_OR_OTHER|||||||0.8876||95.0||||P-value for Severe Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.8876
91669361|NCT00393705|183233315|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0009
91669362|NCT00393705|183233316|SUPERIORITY_OR_OTHER|||||||0.0056||95.0||||P-value for Week 4|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0056
91669363|NCT00393705|183233316|SUPERIORITY_OR_OTHER|||||||0.0421||95.0||||P-value for Week 12|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0421
91714773|NCT05404711|183320560|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
91714774|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and HbA1c.||||0.3
91714775|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|0.5||||0.005|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and HbA1c.||||0.005
91714776|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|0.46||||0.01|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and HbA1c.||||0.01
91714777|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|0.23||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and HbA1c.||||0.2
91714778|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|0.14||||0.5|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and HbA1c.||||0.5
91714779|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|0.29||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose (mg/dL) and HbA1c.||||0.1
91714780|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM correlation of variability (CV) and HbA1c.||||0.4
91714781|NCT05404711|183320561|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.06||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation and HbA1c.||||0.7
91714782|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and laboratory-OGTT fasting glucose.||||0.2
91714783|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT fasting glucose.||||0.3
91714784|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT and lab-OGTT fasting glucose.||||0.6
91714785|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.3
91714786|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|0.09||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.6
91714787|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|0.35||||0.05|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT fasting glucose.||||0.05
91714788|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT fasting glucose.||||0.3
91525959|NCT03502616|182927256|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.012||0.0008|TWO_SIDED|95.0|1.44|5.42|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.42|1.44|0.0008
91635979|NCT01014442|183164176|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.15||||0.0082|TWO_SIDED|95.0|-0.2333|-0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0667|-0.2333|0.0082
91635980|NCT01014442|183164177|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.13||||0.5224|TWO_SIDED|95.0|-0.26|0.5|||Wilcoxon rank sum test|||Cmin of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-0.2600|0.5224
91635981|NCT01014442|183164177|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.16||||0.2088|TWO_SIDED|95.0|-5.29|30.29|||Wilcoxon rank sum test|||Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.2900|-5.2900|0.2088
91635982|NCT01014442|183164177|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.165||||0.1794|TWO_SIDED|95.0|-0.45|0.08|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0800|-0.4500|0.1794
91635983|NCT01014442|183164178|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.125||||0.4027|TWO_SIDED|95.0|-0.38|0.19|||Wilcoxon rank sum test|||Cmin of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.3800|0.4027
91635984|NCT01014442|183164178|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-16.09||||0.0875|TWO_SIDED|95.0|-29.35|6.39|||Wilcoxon rank sum test|||Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.3900|-29.3500|0.0875
91635985|NCT01014442|183164178|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.0112|TWO_SIDED|95.0|-0.35|-0.05|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0500|-0.3500|0.0112
91635986|NCT01014442|183164179|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.215||||0.0818|TWO_SIDED|95.0|-0.56|0.05|||Wilcoxon rank sum test|||Cmin of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0500|-0.5600|0.0818
91635987|NCT01014442|183164179|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-14.03||||0.0945|TWO_SIDED|95.0|-26.9|2.94|||Wilcoxon rank sum test|||Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.9400|-26.9000|0.0945
91635988|NCT01014442|183164179|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.19||||0.0081|TWO_SIDED|95.0|-0.41|-0.04|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0400|-0.4100|0.0081
91635989|NCT01014442|183164180|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.36||||0.3289|TWO_SIDED|95.0|-1.14|0.28|||Wilcoxon rank sum test|||Cmin of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-1.1400|0.3289
91714789|NCT05404711|183320562|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.07||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT fasting glucose.||||0.7
91714790|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and lab-OGTT 2-hour glucose.||||0.6
91714791|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT 2-hour glucose.||||0.1
91635990|NCT01014442|183164180|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-20.3||||0.1243|TWO_SIDED|95.0|-49.39|4.71|||Wilcoxon rank sum test|||Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.7100|-49.3900|0.1243
91635991|NCT01014442|183164180|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.03||||0.8704|TWO_SIDED|95.0|-0.28|0.23|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2300|-0.2800|0.8704
91635992|NCT01014442|183164181|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|5.22||||0.4043|TWO_SIDED|95.0|-5.01|24.49|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||24.4900|-5.0100|0.4043
91635993|NCT01014442|183164182|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.44||||0.893|TWO_SIDED|95.0|-6.07|8.01|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.0100|-6.0700|0.8930
91635994|NCT01014442|183164183|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.935||||0.0819|TWO_SIDED|95.0|-14.31|1.11|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1100|-14.3100|0.0819
91635995|NCT01014442|183164184|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.205||||0.0414|TWO_SIDED|95.0|-19.27|-0.07|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0700|-19.2700|0.0414
91635996|NCT01014442|183164185|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|69.7186||||0.1552|TWO_SIDED|95.0|-23.4659|162.9545|||Wilcoxon rank sum test|||Vz of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||162.9545|-23.4659|0.1552
91635997|NCT01014442|183164185|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.7836||||0.6057|TWO_SIDED|95.0|-3.2675|2.5529|||Wilcoxon rank sum test|||Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.5529|-3.2675|0.6057
91635998|NCT01014442|183164185|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|299.1021||||0.0188|TWO_SIDED|95.0|79.5869|695.1789|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||695.1789|79.5869|0.0188
91635999|NCT01014442|183164186|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|88.959||||0.0659|TWO_SIDED|95.0|-5.7876|209.0183|||Wilcoxon rank sum test|||Vz of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||209.0183|-5.7876|0.0659
91636000|NCT01014442|183164186|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.4456||||0.7842|TWO_SIDED|95.0|-3.1366|2.292|||Wilcoxon rank sum test|||Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.2920|-3.1366|0.7842
91636001|NCT01014442|183164186|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|121.3737||||0.4072|TWO_SIDED|95.0|-233.6483|560.0069|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||560.0069|-233.6483|0.4072
91636002|NCT01014442|183164187|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|207.9933||||0.004|TWO_SIDED|95.0|71.2442|355.1739|||Wilcoxon rank sum test|||Vz of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||355.1739|71.2442|0.0040
91669364|NCT00178711|183233343|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||=|0.67|TWO_SIDED|95.0|0.76|1.53|||Regression, Logistic|||The primary hypothesis was a two-sided test assessing whether the induction of hypothermia modified the percentage of subjects with poor outcomes at 6 months after injury. Percentages in each group were compared using a generalized linear model with a binomial distribution and log link function, logistic regression model with admission age and baseline GCS as covariates.||1.53|0.76|=0.67
91669365|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.08|||||TWO_SIDED|95.0|35.22|74.08||||||TAK-272F: Least square mean (LS) mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95 percent (%) confidence intervals (CI) were calculated using an analysis of variance (ANOVA) model for natural log-transformed data.||74.08|35.22|
91669366|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|117.95|||||TWO_SIDED|95.0|81.32|171.07||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.07|81.32|
91485157|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.38|<0.001
91669367|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.87|||||TWO_SIDED|95.0|188.14|395.76||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.76|188.14|
91669368|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|183.27|||||TWO_SIDED|95.0|126.36|265.81||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||265.81|126.36|
91714792|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and lab-OGTT 2-hour glucose.||||0.2
91714793|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.26||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
91714794|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.27||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
91714795|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.08|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT 2-hour glucose.||||0.08
91714796|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT 2-hour glucose.||||0.4
91485158|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.39|<0.001
91525960|NCT03502616|182927256|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|1.064||0.139|TWO_SIDED|95.0|-0.52|3.68|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.68|-0.52|0.1390
91669369|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.67|||||TWO_SIDED|95.0|68.95|149.9||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.90|68.95|
91714797|NCT05404711|183320563|OTHER|Spearman correlation analysis|Spearman correlation rho|0.28||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT 2-hour glucose.||||0.1
91714798|NCT00325819|183320564|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.053|TWO_SIDED|95.0|0.41|1.01|||unadjusted Poisson regression|||The study sample size of 1000 children was selected to have 80% power to detect a 30% reduction in risk of the primary outcome of rectal temperature \>=38 following vaccination. In 2009, during the enrollment period of our trial, another paper reported the results of a randomized trial of acetaminophen prophylaxis in infants which found significantly lower immune responses to various vaccines in the acetaminophen group. In light of thse findings we elected to stop enrollment in our trial.||1.01|0.41|0.053
91714799|NCT00325819|183320565|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.08||95.0|||||Fisher Exact|||||||0.08
91669370|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.98|||||TWO_SIDED|95.0|92.23|200.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||200.50|92.23|
91485159|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.059
91714800|NCT00325819|183320566|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31||||0.02|TWO_SIDED|95.0|0.12|0.84|||unadjusted Poisson regression|||||0.84|0.12|0.02
91485160|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.33|0.003
91669371|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|62.34|||||TWO_SIDED|95.0|36.17|107.45||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||107.45|36.17|
91714801|NCT00325819|183320567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.14|TWO_SIDED|95.0|0.16|1.28|||unadjusted Poisson regression|||||1.28|0.16|0.14
91714802|NCT00325819|183320568|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.001|TWO_SIDED|95.0|0.25|0.7|||unadjusted Poisson regression|||||0.70|0.25|0.001
91714803|NCT00325819|183320569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.4|TWO_SIDED|95.0|0.21|1.88|||unadjusted Poisson regression|||||1.88|0.21|0.40
91714804|NCT00325819|183320570|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.25|3.94|||unadjusted Poisson regression|||||3.94|0.25|1.00
91714805|NCT00325819|183320571|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.94||||0.18|TWO_SIDED|95.0|0.6|14.34|||unadjusted Poisson regression|||||14.34|0.60|0.18
91714806|NCT01548599|183320593|SUPERIORITY||Odds Ratio, log|2.028||||0.002|TWO_SIDED|95.0|0.766|3.289|||Mixed Models Analysis|||||3.289|0.766|0.002
91714807|NCT01548599|183320594|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91714808|NCT01548599|183320595|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
91714809|NCT01548599|183320596|SUPERIORITY||Odds Ratio (OR)|0.261|STANDARD_ERROR_OF_MEAN|0.398||0.378|TWO_SIDED|95.0|0.013|5.165|||Mixed Models Analysis|||||5.165|0.013|0.378
91714810|NCT01548599|183320597|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91636003|NCT01014442|183164187|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|2.6186||||0.0689|TWO_SIDED|95.0|-0.1999|6.7766|||Wilcoxon rank sum test|||Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.7766|-0.1999|0.0689
91669372|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|93.2|||||TWO_SIDED|95.0|54.08|160.64||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||160.64|54.08|
91669373|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|274.21|||||TWO_SIDED|95.0|159.1|472.63||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||472.63|159.10|
91669374|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|261.12|||||TWO_SIDED|95.0|151.5|450.05||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||450.05|151.50|
91714811|NCT01548599|183320598|SUPERIORITY|||||||0.398|||||||Mixed Models Analysis|||||||0.398
91714812|NCT02674503|183320605|SUPERIORITY|||||||0.02||||||Linear fixed effect models adjusted for time in months|Regression, Linear|||||||0.02
91714813|NCT02674503|183320609|SUPERIORITY|||||||0.13|||||||Regression, Linear|Linear effects model adjusted for time (in months)||||||0.13
91714814|NCT02674503|183320611|SUPERIORITY|||||||0.02|||||||Regression, Linear|Linear mixed effects models adjusted for time (in months)||||||0.02
91714815|NCT01022203|183320618|SUPERIORITY_OR_OTHER||Slope|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.0001
91714816|NCT01022203|183320619|SUPERIORITY_OR_OTHER||Slope|0.004|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.001
91714817|NCT01022203|183320620|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.||||<0.0001
91714818|NCT03163446|183320632|OTHER|Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|10.4||||0.3137|TWO_SIDED|90.0|-6.35|27.19|||Fisher Exact|||||27.19|-6.35|0.3137
91525961|NCT03502616|182927256|SUPERIORITY||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.024||0.5217|TWO_SIDED|95.0|-1.36|2.67|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.67|-1.36|0.5217
91669375|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|112.47|||||TWO_SIDED|95.0|69.34|182.41||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||182.41|69.34|
91669376|NCT02367872|183233357|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|176.75|||||TWO_SIDED|95.0|108.97|286.67||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||286.67|108.97|
91636004|NCT01014442|183164187|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|635.7812||||0.0306|TWO_SIDED|95.0|49.4696|2793.7642|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2793.7642|49.4696|0.0306
91669377|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|57.36|||||TWO_SIDED|95.0|37.76|87.14||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||87.14|37.76|
91669378|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|77.04|||||TWO_SIDED|95.0|50.72|117.03||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||117.03|50.72|
91714819|NCT03163446|183320642|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|42.8||||0.0101|TWO_SIDED|90.0|14.3|71.4|||Fisher Exact|||||71.4|14.3|0.0101
91714820|NCT03163446|183320643|OTHER|P value was ad hoc. Descriptive statistics were performed.||||||0.0646|||||||Fisher Exact||||Descriptive statistics were performed.|||0.0646
91714821|NCT03163446|183320645|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|-21.3||||0.0556|TWO_SIDED|90.0|-45.1|2.5|||Fisher Exact|||||2.5|-45.1|0.0556
91714822|NCT00754741|183320695|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||ANOVA|||||||0.763
91714823|NCT00754741|183320695|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||ANOVA|||||||0.285
91714824|NCT00754741|183320696|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|||||||0.380
91714825|NCT00754741|183320696|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||ANOVA|||||||0.084
91714826|NCT00754741|183320697|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED||||||ANOVA|||||||0.667
91714827|NCT00754741|183320697|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||||||0.530
91714828|NCT00754741|183320698|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
91714829|NCT00754741|183320698|SUPERIORITY_OR_OTHER|||||||0.849|TWO_SIDED||||||ANOVA|||||||0.849
91714830|NCT00754741|183320699|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED||||||Chi-squared|||||||0.134
91714831|NCT00754741|183320699|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||||||0.714
91714832|NCT00754741|183320700|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANOVA|||||||0.291
91636005|NCT01014442|183164188|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|4.7477||||0.9029|TWO_SIDED|95.0|-73.5212|59.8304|||Wilcoxon rank sum test|||Vz of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||59.8304|-73.5212|0.9029
91636006|NCT01014442|183164188|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0077||||0.9692|TWO_SIDED|95.0|-3.6739|3.9521|||Wilcoxon rank sum test|||Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.9521|-3.6739|0.9692
91636007|NCT01014442|183164188|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-149.7962||||0.3744|TWO_SIDED|95.0|-644.4526|311.9735|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||311.9735|-644.4526|0.3744
91636008|NCT01014442|183164189|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|7.8422||||0.1362|TWO_SIDED|95.0|-3.911|18.4444|||Wilcoxon rank sum test|||CL of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||18.4444|-3.9110|0.1362
91636009|NCT01014442|183164189|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1609||||0.4325|TWO_SIDED|95.0|-0.5693|0.271|||Wilcoxon rank sum test|||CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2710|-0.5693|0.4325
91636010|NCT01014442|183164189|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|47.2686||||0.0316|TWO_SIDED|95.0|4.197|112.7806|||Wilcoxon rank sum test|||CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||112.7806|4.1970|0.0316
91636011|NCT01014442|183164190|SUPERIORITY_OR_OTHER||Hodges-Lehmann estmator|19.0536||||0.0572|TWO_SIDED|95.0|-0.425|35.3852|||Wilcoxon rank sum test|||CL of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||35.3852|-0.4250|0.0572
91636012|NCT01014442|183164190|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.3541||||0.3198|TWO_SIDED|95.0|-0.2524|1.1097|||Wilcoxon rank sum test|||CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1097|-0.2524|0.3198
91636013|NCT01014442|183164190|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|54.0322||||0.0845|TWO_SIDED|95.0|-6.7706|160.3469|||Wilcoxon rank sum test|||CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||160.3469|-6.7706|0.0845
91636014|NCT01014442|183164191|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|25.0037||||0.0048|TWO_SIDED|95.0|8.2373|43.5102|||Wilcoxon rank sum test|||CL of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||43.5102|8.2373|0.0048
91636015|NCT01014442|183164191|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.4297||||0.0277|TWO_SIDED|95.0|0.034|0.9925|||Wilcoxon rank sum test|||CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.9925|0.0340|0.0277
91636016|NCT01014442|183164191|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|318.5455||||0.0002|TWO_SIDED|95.0|154.1902|526.1716|||Wilcoxon rank sum test|||CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||526.1716|154.1902|0.0002
91636017|NCT01014442|183164192|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.579||||0.9417|TWO_SIDED|95.0|-14.5052|11.6346|||Wilcoxon rank sum test|||CL of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||11.6346|-14.5052|0.9417
91636018|NCT01014442|183164192|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1817||||0.2941|TWO_SIDED|95.0|-0.1954|0.6246|||Wilcoxon rank sum test|||CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.6246|-0.1954|0.2941
91636019|NCT01014442|183164192|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.9076||||0.817|TWO_SIDED|95.0|-84.8234|109.9321|||Wilcoxon rank sum test|||CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||109.9321|-84.8234|0.8170
91714833|NCT00754741|183320700|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANOVA|||||||0.968
91714834|NCT00754741|183320701|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||ANOVA|||||||0.671
91714835|NCT00754741|183320701|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANOVA|||||||0.399
91714836|NCT00754741|183320702|SUPERIORITY_OR_OTHER|||||||0.829|TWO_SIDED||||||ANOVA|||||||0.829
91714837|NCT00754741|183320702|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED||||||ANOVA|||||||0.283
91714838|NCT00754741|183320703|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||ANOVA|||||||0.971
91714839|NCT00754741|183320703|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||ANOVA|||||||0.115
91669379|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|206.41|||||TWO_SIDED|95.0|135.88|313.54||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||313.54|135.88|
91669380|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|143.11|||||TWO_SIDED|95.0|94.21|217.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||217.39|94.21|
91669381|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|85.31|||||TWO_SIDED|95.0|51.03|142.61||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||142.61|51.03|
91669382|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|131.63|||||TWO_SIDED|95.0|78.74|220.04||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||220.04|78.74|
91669383|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|70.38|||||TWO_SIDED|95.0|40.42|122.53||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||122.53|40.42|
91669384|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|55.03|||||TWO_SIDED|95.0|31.61|95.81||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||95.81|31.61|
91669385|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|125.96|||||TWO_SIDED|95.0|72.35|219.3||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||219.30|72.35|
91714840|NCT00754741|183320704|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANOVA|||||||0.573
91714841|NCT00754741|183320704|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||ANOVA|||||||0.443
91714842|NCT00754741|183320705|SUPERIORITY_OR_OTHER|||||||0.469|TWO_SIDED||||||ANOVA|||||||0.469
91714843|NCT00754741|183320705|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANOVA|||||||0.369
91485161|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.001|TWO_SIDED|95.0|-0.36|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.36|0.001
91669386|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|103.93|||||TWO_SIDED|95.0|59.7|180.95||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||180.95|59.70|
91669387|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|91.97|||||TWO_SIDED|95.0|49.45|171.06||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.06|49.45|
91669388|NCT02367872|183233358|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.33|||||TWO_SIDED|95.0|74.91|259.15||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||259.15|74.91|
91669389|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.39|||||TWO_SIDED|95.0|35.45|74.49||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||74.49|35.45|
91669390|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|118.43|||||TWO_SIDED|95.0|81.7|171.68||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.68|81.70|
91792687|NCT01293799|183463100|OTHER||Hazard Ratio (HR)|0.56||||0.038|TWO_SIDED|95.0|0.33|0.97||Unit of measure: Polycystic kidney disease as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Cox regression||"The association of Diabetic nephropathy as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found."||0.97|0.33|0.038
91669391|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.83|||||TWO_SIDED|95.0|188.21|395.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.50|188.21|
91714844|NCT00754741|183320706|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||ANOVA|||||||0.779
91714845|NCT00754741|183320706|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||ANOVA|||||||0.733
91714846|NCT00754741|183320707|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED||||||ANOVA|||||||0.952
91714847|NCT00754741|183320707|SUPERIORITY_OR_OTHER|||||||0.856|TWO_SIDED||||||ANOVA|||||||0.856
91714848|NCT00754741|183320708|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||Chi-squared|||||||0.419
91485162|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.24|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.51|<0.001
91485163|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
91714849|NCT00754741|183320708|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED||||||Chi-squared|||||||0.998
91714850|NCT04152200|183320709|OTHER|Not applied|Least Squares (LS) Mean|-33.33|STANDARD_ERROR_OF_MEAN|17.63|||TWO_SIDED|95.0|-81.82|15.16|||Mixed model repeated measures (MMRM)|||Restricted maximum likelihood (REML) based Mixed Model Repeated Measures (MMRM) was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||15.16|-81.82|
91714851|NCT04152200|183320710|OTHER|Not applied|Least Squares (LS) Mean|-42.43|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-50.71|-34.15|||MMRM|||REML based Mixed Model Repeated Measures MMRM was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||-34.15|-50.71|
91714852|NCT02699996|183320757|SUPERIORITY||Mean Difference (Final Values)|0.52|||<|0.01|TWO_SIDED|95.0|0.17|0.86|||t-test, 2 sided|df = 14||RTQ-Survivor Adolescent Responsibility Score||0.86|0.17|<.01
91714853|NCT02699996|183320757|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.01|TWO_SIDED|95.0|0.27|1.07|||t-test, 2 sided|df=14||RTQ-Overall Readiness Score||1.07|0.27|<.01
91714854|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.02|TWO_SIDED|95.0|0.05|0.42|||t-test, 2 sided|df=14||TRI-total Score||0.42|0.05|0.02
91714855|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.01|TWO_SIDED|95.0|0.26|0.73|||t-test, 2 sided|df=14||TRI Knowledge score||0.73|0.26|<.01
91714856|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.053|TWO_SIDED|95.0|-0.0044|0.6|||t-test, 2 sided|df=14||TRI Skills/Self-Efficacy Score||0.60|-0.0044|0.053
91636020|NCT01014442|183164193|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-2.4102||||0.2798|TWO_SIDED|95.0|-8.5642|3.0044|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.0044|-8.5642|0.2798
91636021|NCT01014442|183164193|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|72.7203||||0.4063|TWO_SIDED|95.0|-107.1596|393.5295|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||393.5295|-107.1596|0.4063
91636022|NCT01014442|183164193|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-3.6042||||0.0441|TWO_SIDED|95.0|-8.1854|-0.1887|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.1887|-8.1854|0.0441
91636023|NCT01014442|183164194|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-5.8077||||0.051|TWO_SIDED|95.0|-11.7302|0.0033|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0033|-11.7302|0.0510
91636024|NCT01014442|183164194|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-171.159||||0.2733|TWO_SIDED|95.0|-361.4437|171.9652|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||171.9652|-361.4437|0.2733
91636025|NCT01014442|183164194|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.9621||||0.0718|TWO_SIDED|95.0|-4.8456|0.2067|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2067|-4.8456|0.0718
91636026|NCT01014442|183164195|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.6964||||0.0002|TWO_SIDED|95.0|-13.7713|-4.6498|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-4.6498|-13.7713|0.0002
91636027|NCT01014442|183164195|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-268.9537||||0.0058|TWO_SIDED|95.0|-506.7782|-77.397|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-77.3970|-506.7782|0.0058
91636028|NCT01014442|183164195|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.828|||<|0.0001|TWO_SIDED|95.0|-7.1455|-2.6133|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.6133|-7.1455|<0.0001
91636029|NCT01014442|183164196|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.7477||||0.7144|TWO_SIDED|95.0|-12.101|14.6563|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||14.6563|-12.1010|0.7144
91636030|NCT01014442|183164196|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-156.3255||||0.3413|TWO_SIDED|95.0|-526.0765|195.8348|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||195.8348|-526.0765|0.3413
91636031|NCT01014442|183164196|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.888||||0.6251|TWO_SIDED|95.0|-3.0288|4.2273|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2273|-3.0288|0.6251
91636032|NCT01014442|183164197|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|24.315||||0.2342|TWO_SIDED|95.0|-16.0292|79.365|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||79.3650|-16.0292|0.2342
91714857|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.03|TWO_SIDED|95.0|0.02|0.24|||t-test, 2 sided|df=14||TRI Beliefs/Expectations score||0.24|0.02|0.03
91792688|NCT01293799|183463101|OTHER||Hazard Ratio (HR)|1.92||||0.52|TWO_SIDED|95.0|0.27|13.68||Unit of measure: Ischemic kidney disease as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Ischemic kidney disease as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression."||13.68|0.27|0.52
91669392|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|184.13|||||TWO_SIDED|95.0|127.02|266.91||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||266.91|127.02|
91669393|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.64|||||TWO_SIDED|95.0|69.04|149.64||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.64|69.04|
91669394|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|136.59|||||TWO_SIDED|95.0|92.78|201.09||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||201.09|92.78|
91669395|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|59.17|||||TWO_SIDED|95.0|33.99|102.99||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.99|33.99|
91669396|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.04|||||TWO_SIDED|95.0|55.75|168.9||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||168.90|55.75|
91669397|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|260.03|||||TWO_SIDED|95.0|149.39|452.6||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||452.60|149.39|
91669398|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|319.06|||||TWO_SIDED|95.0|183.31|555.34||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||555.34|183.31|
91669399|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|130.07|||||TWO_SIDED|95.0|81.66|207.18||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.18|81.66|
91669400|NCT02367872|183233359|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|192.63|||||TWO_SIDED|95.0|120.94|306.83||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||306.83|120.94|
91669401|NCT02367872|183233360|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.22|||||TWO_SIDED|95.0|40.05|90.56||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||90.56|40.05|
91669402|NCT02367872|183233360|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.39|||||TWO_SIDED|95.0|64.77|146.46||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||146.46|64.77|
91669403|NCT02367872|183233360|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.6|||||TWO_SIDED|95.0|74.21|167.82||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.82|74.21|
91669404|NCT02367872|183233360|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|138.79|||||TWO_SIDED|95.0|92.29|208.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||208.70|92.29|
91669405|NCT02367872|183233360|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.18|||||TWO_SIDED|95.0|87.91|207.87||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.87|87.91|
91669406|NCT02367872|183233360|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|323.75|||||TWO_SIDED|95.0|210.54|497.85||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||497.85|210.54|
91669407|NCT02367872|183233361|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|67.61|||||TWO_SIDED|95.0|42.17|108.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||108.39|42.17|
91669408|NCT02367872|183233361|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|63.7|||||TWO_SIDED|95.0|39.73|102.12||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.12|39.73|
91669409|NCT02367872|183233361|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|84.45|||||TWO_SIDED|95.0|52.67|135.38||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||135.38|52.67|
91669410|NCT02367872|183233361|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|108.54|||||TWO_SIDED|95.0|67.7|174.01||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||174.01|67.70|
91714858|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.01|TWO_SIDED|95.0|0.11|0.69|||t-test, 2 sided|df=14||TRI Goals/Motivation score||0.69|0.11|<.01
91485164|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.038
91669411|NCT02367872|183233361|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|113.25|||||TWO_SIDED|95.0|69.62|184.24||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||184.24|69.62|
91669412|NCT02367872|183233361|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|312.89|||||TWO_SIDED|95.0|192.34|509.0||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||509.00|192.34|
91669413|NCT02367872|183233362|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.68|||||TWO_SIDED|95.0|40.35|91.27||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||91.27|40.35|
91669414|NCT02367872|183233362|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|98.01|||||TWO_SIDED|95.0|65.17|147.41||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||147.41|65.17|
91669415|NCT02367872|183233362|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.68|||||TWO_SIDED|95.0|74.25|167.96||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.96|74.25|
91669416|NCT02367872|183233362|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.7|||||TWO_SIDED|95.0|92.88|210.11||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||210.11|92.88|
91714859|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.61|TWO_SIDED|95.0|-0.16|0.26|||t-test, 2 sided|df=14||Relationship/Communication Score||0.26|-0.16|0.61
91714860|NCT02699996|183320758|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.65|TWO_SIDED|95.0|-0.37|0.57|||t-test, 2 sided|df=14||TRI Psychosocial/Emotional Score||0.57|-0.37|0.65
91714861|NCT02699996|183320759|SUPERIORITY||Median Difference (Final Values)|-1.64||||0.56|TWO_SIDED|95.0|-7.62|4.34|||t-test, 2 sided|df = 13||||4.34|-7.62|.56
91714862|NCT02699996|183320760|SUPERIORITY||Mean Difference (Final Values)|-1.74||||0.42|TWO_SIDED|95.0|-6.23|2.75|||t-test, 2 sided|df = 14||||2.75|-6.23|.42
91714863|NCT02699996|183320761|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.26|TWO_SIDED|95.0|-0.8|0.23|||t-test, 2 sided|df = 14||||0.23|-0.80|.26
91792689|NCT01293799|183463102|OTHER||Hazard Ratio (HR)|1.26||||0.13|TWO_SIDED|95.0|0.93|1.71||Unit of measure: Nephrosclerosis/Hypertension as primary cause of kidney failure vs. all other causes. P \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Nephrosclerosis/Hypertension as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression."||1.71|0.93|0.13
91525962|NCT03502616|182927256|SUPERIORITY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|1.027||0.1415|TWO_SIDED|95.0|-0.51|3.54|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.54|-0.51|0.1415
91669417|NCT02367872|183233362|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.08|||||TWO_SIDED|95.0|87.75|207.92||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.92|87.75|
91669418|NCT02367872|183233362|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|325.28|||||TWO_SIDED|95.0|211.32|500.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||500.70|211.32|
91669419|NCT05718648|183233374|OTHER||Ratio of adjusted geometric means [%]|129.24|||||TWO_SIDED|90.0|91.62|182.31|||||Ratio \[%\] = (adjusted geometric mean of severe renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 37.5|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||182.31|91.62|
91714864|NCT02699996|183320762|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.03|TWO_SIDED|95.0|0.03|0.52|||t-test, 2 sided|df = 14||||0.52|0.03|.03
91714865|NCT02699996|183320763|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.2|TWO_SIDED|95.0|-0.12|0.52|||t-test, 2 sided|df = 14||Body Health Subscale||0.52|-0.12|.20
91714866|NCT02699996|183320763|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.4|TWO_SIDED|95.0|-0.46|0.2|||t-test, 2 sided|df = 14||Personal Growth Subscale||0.20|-0.46|.40
91714867|NCT02699996|183320763|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.29|TWO_SIDED|95.0|-0.09|0.29|||t-test, 2 sided|df = 14||Memory Subscale||0.29|-0.09|.29
91714868|NCT02699996|183320764|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03|||t-test, 2 sided|df = 14||||0.03|-0.40|.08
91714869|NCT00871624|183320777|NON_INFERIORITY_OR_EQUIVALENCE|A difference in the mean four-point NIV intolerance score of 1 over the course of the study or between groups was considered through investigator consensus to be clinically meaningful. Assuming that the SD of NIV intolerance scores was 1 and that an alpha of 0.05 would be used for testing, it was determined that 18 subjects were needed in each group to achieve an 80% power.|Odds Ratio (OR)|1.44||||0.54|TWO_SIDED|95.0|0.44|4.7|||Chi-squared|||||4.7|0.44|0.54
91714870|NCT00871624|183320778|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
91714871|NCT01294423|183320805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0853|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.18|-0.52|<0.0001
91485165|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.33|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.33|0.007
91485166|NCT00809354|182843573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.42|<0.001
91714872|NCT01294423|183320805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.0851|<|0.0001|TWO_SIDED|95.0|-0.56|-0.23||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.23|-0.56|<0.0001
91669420|NCT05718648|183233374|OTHER||Ratio of adjusted geometric means [%]|137.44|||||TWO_SIDED|90.0|89.06|212.12|||||Ratio \[%\] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 52.4|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||212.12|89.06|
91669421|NCT05718648|183233375|OTHER||Ratio of adjusted geometric means [%]|131.83|||||TWO_SIDED|90.0|93.32|186.22|||||Ratio \[%\] = (adjusted geometric mean of severe renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 37.7|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||186.22|93.32|
91714873|NCT01294423|183320806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|2.902|<|0.0001|TWO_SIDED|95.0|-20.1|-8.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-8.7|-20.1|<0.0001
91714874|NCT01294423|183320806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|2.892|<|0.0001|TWO_SIDED|95.0|-25.2|-13.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.8|-25.2|<0.0001
91714875|NCT01294423|183320807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.3533||0.0003|TWO_SIDED|95.0|-1.98|-0.59||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.59|-1.98|0.0003
91636033|NCT01014442|183164198|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-13.5592||||0.1964|TWO_SIDED|95.0|-37.395|5.4825|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.4825|-37.3950|0.1964
91636034|NCT01014442|183164199|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-22.7878||||0.0672|TWO_SIDED|95.0|-44.8217|3.7573|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.7573|-44.8217|0.0672
91669422|NCT05718648|183233375|OTHER||Ratio of adjusted geometric means [%]|127.43|||||TWO_SIDED|90.0|85.92|188.99|||||Ratio \[%\] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 43.5|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||188.99|85.92|
91485167|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
91485168|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
91636035|NCT01014442|183164200|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-21.4737||||0.2453|TWO_SIDED|95.0|-64.1567|8.5708|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.5708|-64.1567|0.2453
91669423|NCT05718648|183233376|OTHER||Ratio of adjusted geometric means [%]|86.06|||||TWO_SIDED|90.0|64.88|114.15|||||Ratio \[%\] = (adjusted geometric mean of severe renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 30.5|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||114.15|64.88|
91669424|NCT05718648|183233376|OTHER||Ratio of adjusted geometric means [%]|96.57|||||TWO_SIDED|90.0|56.8|164.16|||||Ratio \[%\] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 66.2|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||164.16|56.80|
91669425|NCT05718648|183233377|OTHER||Ratio of adjusted geometric means [%]|83.15|||||TWO_SIDED|90.0|60.91|113.51|||||Ratio \[%\] = (adjusted geometric mean of severe renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 33.8|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||113.51|60.91|
91669426|NCT05718648|183233377|OTHER||Ratio of adjusted geometric means [%]|90.49|||||TWO_SIDED|90.0|52.4|156.26|||||Ratio \[%\] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 68.5|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||156.26|52.40|
91714876|NCT01294423|183320807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.354||0.0001|TWO_SIDED|95.0|-2.08|-0.69||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.69|-2.08|0.0001
91714877|NCT02026141|183320814|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
91714878|NCT01248455|183320825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).||||0.56
91714879|NCT00917124|183320844|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||"Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.~Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group."||||0.002
91714880|NCT02937623|183320926|OTHER||Least square mean difference|-0.44|||<|0.0001||95.0|-0.591|-0.297|||ANCOVA|ANCOVA model: change from baseline in Schiff sensitivity score as response and treatment as factors and baseline Schiff sensitivity score as covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.297|-0.591|<.0001
91714881|NCT03675360|183320930|SUPERIORITY||Mean Difference (Net)|-0.23|||<|0.05|TWO_SIDED|95.0|-0.32|-0.14|||linear mixed effects model|||||-0.14|-0.32|<0.05
91669427|NCT05718648|183233378|OTHER||Ratio of adjusted geometric means [%]|128.55|||||TWO_SIDED|90.0|87.42|189.02|||||Ratio \[%\] = (adjusted geometric mean of severe renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 39.8|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||189.02|87.42|
91714882|NCT03675360|183320931|SUPERIORITY||Mean Difference (Net)|-10.3|||<|0.05|TWO_SIDED|95.0|-15.6|-4.9|||linear mixed effects model|||||-4.9|-15.6|<0.05
91714883|NCT03675360|183320932|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.05|TWO_SIDED|95.0|-7.3|0.9|||linear mixed effects model|||||0.9|-7.3|<0.05
91714884|NCT03675360|183320933|SUPERIORITY||Median Difference (Final Values)|-0.13|||<|0.05|TWO_SIDED|95.0|-0.31|0.05|||linear mixed effects model|||||0.05|-0.31|<0.05
91714885|NCT03675360|183320934|SUPERIORITY||Mean Difference (Net)|-5.9|||<|0.05|TWO_SIDED|95.0|-7.4|-4.4|||linear mixed effects model|||||-4.4|-7.4|<0.05
91714886|NCT03675360|183320935|SUPERIORITY||Mean Difference (Net)|-6.2|||<|0.05|TWO_SIDED|95.0|-10.5|-2.0|||linear mixed effects model|||||-2.0|-10.5|<0.05
91714887|NCT03675360|183320936|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.05|TWO_SIDED|95.0|-3.7|-1.1|||linear mixed effects model|||||-1.1|-3.7|<0.05
91525963|NCT03502616|182927256|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.128||0.0533|TWO_SIDED|95.0|-0.03|4.41|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.41|-0.03|0.0533
91485169|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
91714888|NCT03675360|183320937|SUPERIORITY||Mean Difference (Net)|-2.6|||<|0.05|TWO_SIDED|95.0|-5.2|0.0|||linear mixed effects model|||||0|-5.2|<0.05
91669428|NCT05718648|183233378|OTHER||Ratio of adjusted geometric means [%]|136.16|||||TWO_SIDED|90.0|88.41|209.69|||||Ratio \[%\] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 52.1|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||209.69|88.41|
91669429|NCT05718648|183233379|OTHER||Ratio of adjusted geometric means [%]|125.06|||||TWO_SIDED|90.0|85.27|183.4|||||Ratio \[%\] = (adjusted geometric mean of severe renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 39.6|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||183.40|85.27|
91669430|NCT05718648|183233379|OTHER||Ratio of adjusted geometric means [%]|126.61|||||TWO_SIDED|90.0|85.3|187.92|||||Ratio \[%\] = (adjusted geometric mean of moderate renal impairment / adjusted geometric mean matching control)\*100. Intra-matched pair geometric coefficient of variation (gCV) \[%\] = 43.6|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'degree of renal impairment' as fixed effect as well as 'matched pair' as random effect. These quantities were then back-transformed to the original scale.||187.92|85.30|
91669431|NCT05707403|183233434|OTHER||Ratio (T/R) [%]|73.15|||||TWO_SIDED|90.0|67.32|79.48|||||Ratio \[%\] is calculated as Test / Reference Intra-individual geometric Coefficient of Variation (gCV) = 8.8 %.|Analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model and then then back-transformed to the original scale to provide the point estimate and 90% confidence interval. The model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas the 'formulation' effect was considered as fixed.||79.48|67.32|
91669432|NCT05707403|183233435|OTHER||Ratio (T/R) [%]|33.58|||||TWO_SIDED|90.0|29.4|38.36|||||Ratio \[%\] is calculated as Test / Reference Intra-individual geometric Coefficient of Variation (gCV) = 14.1 %|Analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model and then then back-transformed to the original scale to provide the point estimate and 90% confidence interval. The model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas the 'formulation' effect was considered as fixed.||38.36|29.40|
91714889|NCT03675360|183320938|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.05|TWO_SIDED|95.0|-6.7|-2.6|||linear mixed effects model|||||-2.6|-6.7|<0.05
91714890|NCT03675360|183320939|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.05|TWO_SIDED|95.0|-1.8|0.3|||linear mixed effects model|||||0.3|-1.8|<0.05
91714891|NCT02533934|183320942|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
91714892|NCT02533934|183320942|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
91714893|NCT02533934|183320942|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
91525964|NCT03502616|182927257|SUPERIORITY||LS mean difference|1.25|STANDARD_ERROR_OF_MEAN|0.352||0.0005|TWO_SIDED|95.0|0.55|1.94|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.94|0.55|0.0005
91714894|NCT02533934|183320942|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
91714895|NCT02533934|183320944|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.001|||||||Wilcoxon (Signed Rank Test)|||||||<0.001
91714896|NCT01569126|183320953|SUPERIORITY_OR_OTHER||Slope|0.026||||||95.0|||||||The correlation of time-matched change from baseline QTcF interval (dependent variable) to the time-matched plasma concentration of total fluoxetine and norfluoxetine (covariate) and participant (random effect).|||||
91714897|NCT01585246|183320956|OTHER||Maximum Tolerated Dose (MTD)|960.0|||||TWO_SIDED|||||||||The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.||||
91485170|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
91485171|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
91714898|NCT00196105|183321073|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Log Rank|||||||.057
91714899|NCT00196105|183321074|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||.04
91669433|NCT00979212|183233575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||One-sided test at significance level of 0.05|Fisher Exact|||Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR \> 1, where odds ratio (OR)= \[p2\*(1- p1)\]/ \[p1\*(1- p2)\], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher's exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.||||0.96
91669434|NCT00337428|183233594|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91669435|NCT00337428|183233595|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91714900|NCT00196105|183321074|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Death is censored for Kaplan-Meier analysis.|Log Rank|||||||.007
91714901|NCT00196105|183321074|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Chi-squared|||||||.69
91714902|NCT00196105|183321074|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is adjusted for multiple comparisons.|Chi-squared|||6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined||||.02
91714903|NCT00196105|183321075|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||.16
91714904|NCT00196105|183321077|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Log Rank|||||||.32
91714905|NCT00196105|183321077|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||.69
91714906|NCT02227784|183321079|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.48|||<|0.001|TWO_SIDED|95.0|-44.4|-23.3|||ANCOVA|||||-23.3|-44.4|<0.001
91714907|NCT02227784|183321079|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-27.24|||<|0.001|TWO_SIDED|95.0|-36.6|-18.5|||ANCOVA|||||-18.5|-36.6|<0.001
91525965|NCT03502616|182927257|SUPERIORITY||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|0.95|2.45|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.95|<0.0001
91714908|NCT02227784|183321079|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.14||||0.045|TWO_SIDED|95.0|-12.2|-0.22|||ANCOVA|||||-0.22|-12.2|0.045
91714909|NCT02227784|183321080|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|125.28|||<|0.001|TWO_SIDED|95.0|117.1|133.6|||Mixed Models Analysis|||||133.6|117.1|<0.001
91714910|NCT02227784|183321080|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|131.48|||<|0.001|TWO_SIDED|95.0|123.5|139.5|||Mixed Models Analysis|||||139.5|123.5|<0.001
91714911|NCT02227784|183321080|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|127.57|||<|0.001|TWO_SIDED|95.0|120.1|135.0|||Mixed Models Analysis|||||135.0|120.1|<0.001
91714912|NCT02227784|183321081|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|46.35|||<|0.001|TWO_SIDED|95.0|40.79|51.98|||ANCOVA|||||51.98|40.79|<0.001
91714913|NCT02227784|183321081|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|52.22|||<|0.001|TWO_SIDED|95.0|47.12|57.33|||ANCOVA|||||57.33|47.12|<0.001
91714914|NCT02227784|183321081|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|48.44|||<|0.001|TWO_SIDED|95.0|43.82|52.86|||ANCOVA|||||52.86|43.82|<0.001
91714915|NCT02227784|183321082|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.47|||<|0.001|TWO_SIDED|95.0|-33.4|-20.0|||Mixed Models Analysis|||||-20.0|-33.4|<0.001
91714916|NCT02227784|183321082|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-22.02|||<|0.001|TWO_SIDED|95.0|-28.4|-15.9|||Mixed Models Analysis|||||-15.9|-28.4|<0.001
91714917|NCT02227784|183321082|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-11.5|-2.68|||Mixed Models Analysis|||||-2.68|-11.5|<0.001
91714918|NCT02227784|183321083|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-23.16|||<|0.001|TWO_SIDED|95.0|-30.0|-16.5|||ANCOVA|||||-16.5|-30.00|<0.001
91669436|NCT00337428|183233596|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91669437|NCT00337428|183233597|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91714919|NCT02227784|183321083|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-16.42|||<|0.001|TWO_SIDED|95.0|-22.3|-10.6|||ANCOVA|||||-10.6|-22.3|<0.001
91714920|NCT02227784|183321083|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-4.11||||0.062|TWO_SIDED|95.0|-8.47|0.15|||ANCOVA|||||0.15|-8.47|0.062
91714921|NCT02227784|183321084|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|38.05|||<|0.001|TWO_SIDED|95.0|30.17|45.88|||ANCOVA|||||45.88|30.17|<0.001
91714922|NCT02227784|183321084|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|42.12|||<|0.001|TWO_SIDED|95.0|34.29|49.76|||ANCOVA|||||49.76|34.29|<0.001
91714923|NCT02227784|183321084|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.64|||<|0.001|TWO_SIDED|95.0|33.2|46.08|||ANCOVA|||||46.08|33.20|<0.001
91714924|NCT02227784|183321085|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.18|||<|0.001|TWO_SIDED|95.0|-44.9|-22.3|||ANCOVA|||||-22.3|-44.9|<0.001
91714925|NCT02227784|183321085|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-32.63|||<|0.001|TWO_SIDED|95.0|-44.0|-21.8|||ANCOVA|||||-21.8|-44.0|<0.001
91714926|NCT02227784|183321085|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-42.15|||<|0.001|TWO_SIDED|95.0|-50.9|-33.4|||ANCOVA|||||-33.4|-50.9|<0.001
91714927|NCT01705977|183321113|OTHER||Difference in percentage versus placebo|0.1|||||TWO_SIDED|95.0|-0.31|0.51|||||95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-0.31|
91669438|NCT00337428|183233598|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669439|NCT00337428|183233599|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669440|NCT00337428|183233600|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669441|NCT00337428|183233601|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669442|NCT00337428|183233602|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669443|NCT00337428|183233603|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669444|NCT00337428|183233604|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669445|NCT00337428|183233605|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669446|NCT00337428|183233606|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
91669447|NCT00337428|183233607|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91485172|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
91669448|NCT00337428|183233608|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91669449|NCT00337428|183233609|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91669450|NCT00337428|183233610|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91669451|NCT02618382|183233612|SUPERIORITY||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
91669452|NCT02618382|183233613|SUPERIORITY||||||<|0.05||||||Paired comparison of hematoma thickness at defined time point means determined by ANOVA for continuous variables.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
91669453|NCT02618382|183233614|OTHER||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables and by chi-squared test for categorical values in grouped mRS scores.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
91669454|NCT03223909|183233615|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of groups in the baseline visit versus final visit"||||||0.08|||||||ANOVA|||||||0.080
91669455|NCT03223909|183233615|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis between groups in the final visit"||||||0.848|||||||ANOVA|||||||0.848
91669456|NCT03223909|183233616|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.468|||||||Chi-squared, Corrected|||||||0.468
91669457|NCT03223909|183233617|NON_INFERIORITY|population analysis was per protocol||||||0.0001|||||||ANOVA|||||||0.0001
91669458|NCT03223909|183233617|NON_INFERIORITY|population analysis was per protocol||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.650
91485173|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
91669459|NCT03223909|183233618|NON_INFERIORITY|"It was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit."||||||0.003|||||||ANOVA|||||||0.003
91636036|NCT01014442|183164201|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00237||||0.1362|TWO_SIDED|95.0|-0.00734|0.00106|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00106|-0.00734|0.1362
91636037|NCT01014442|183164201|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.04797||||0.4325|TWO_SIDED|95.0|-0.08467|0.26322|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.26322|-0.08467|0.4325
91636038|NCT01014442|183164201|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00311||||0.0316|TWO_SIDED|95.0|-0.00645|-0.00029|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00029|-0.00645|0.0316
91636039|NCT01014442|183164201|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000158||||0.3269|TWO_SIDED|95.0|-0.0000134|0.0000552|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000552|-0.0000134|0.3269
91636040|NCT01014442|183164202|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00383||||0.0572|TWO_SIDED|95.0|-0.00761|0.0001|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00010|-0.00761|0.0572
91636041|NCT01014442|183164202|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.09626||||0.3198|TWO_SIDED|95.0|-0.25269|0.11464|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.11464|-0.25269|0.3198
91636042|NCT01014442|183164202|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00131||||0.0845|TWO_SIDED|95.0|-0.00352|0.00013|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00352|0.0845
91669460|NCT03223909|183233618|NON_INFERIORITY|It was considered as not inferior when the treatments did not present differences greater than 20% Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit.||||||0.003|||||||ANOVA|||||||0.003
91669461|NCT03223909|183233619|NON_INFERIORITY|"the statistical analysis was carried out by intention to treat~It was considered as not inferior when the treatments did not present differences greater than 20%"||||||0.93|||||||Chi-squared|||||||0.930
91669462|NCT03223909|183233620|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.548|||||||ANOVA|||||||0.548
91669463|NCT03223909|183233621|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.17|||||||ANOVA|||||||0.170
91669464|NCT03223909|183233622|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.085|||||||Chi-squared, Corrected|||||||0.085
91669465|NCT00974350|183233645|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.353||0.0031|TWO_SIDED|95.0|-1.84|-0.44|||ANOVA|LS Mean difference from SABER-Placebo||Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT||-0.44|-1.84|0.0031
91669466|NCT00974350|183233646|SUPERIORITY|||||||0.0909|||||||Cochran-Mantel-Haenszel|Stratified by pooled study sites||Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication||||0.0909
91669467|NCT01344018|183233651|SUPERIORITY|"Time assessment biases were taken into account for the primary endpoint:~* Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24.~* Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24."|Hazard Ratio (HR)|1.01||||0.955|TWO_SIDED|95.0|0.71|1.44||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|The time assessment biases correction described before was not applied to patients for whom death was the first event.|The arm having surgery alone was the reference arm.|Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.||1.44|0.71|0.955
91669468|NCT01344018|183233656|SUPERIORITY|ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.|Hazard Ratio (HR)|1.09||||0.658|TWO_SIDED|95.0|0.74|1.6||A 5% significance level was considered as a threshold for statistical significance.|Fine and Gray model|||||1.60|0.74|0.658
91669469|NCT01344018|183233657|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.595|TWO_SIDED|95.0|0.58|1.36||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|||||1.36|0.58|0.595
91636043|NCT01014442|183164202|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.1769|TWO_SIDED|95.0|-0.000025|0.0000043|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000043|-0.0000250|0.1769
91636044|NCT01014442|183164203|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0049||||0.0048|TWO_SIDED|95.0|-0.00876|-0.00148|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00148|-0.00876|0.0048
91669470|NCT01344018|183233658|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.615|TWO_SIDED|95.0|0.65|2.05|||Regression, Cox|||||2.05|0.65|0.615
91669471|NCT04010227|183233670|SUPERIORITY||partial correlation|0.08||||0.6|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. multiply imputed data were used in analyses.||||0.40|-0.23|0.60
91669472|NCT04010227|183233671|SUPERIORITY||partial correlation|0.02||||0.96|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.34|-0.29|0.96
91669473|NCT04010227|183233672|SUPERIORITY||partial correlation|0.06||||0.75|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.75
91669474|NCT04010227|183233673|SUPERIORITY||partial correlation|0.09||||0.33|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.40|-0.23|0.33
91669475|NCT04010227|183233674|SUPERIORITY||partial correlation|0.03||||0.91|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.29|0.91
91669476|NCT04010227|183233675|SUPERIORITY||partial correlation|0.06||||0.74|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction for patient physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.74
91669477|NCT04010227|183233675|SUPERIORITY||partial correlation|0.14||||0.24|TWO_SIDED|95.0|-0.18|0.45||P-value for study group x time interaction for patient psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.45|-0.18|0.24
91669478|NCT04010227|183233675|SUPERIORITY||partial correlation|0.06||||0.78|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for patient existential quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.78
91636045|NCT01014442|183164203|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.14764||||0.0277|TWO_SIDED|95.0|-0.31026|-0.01067|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.01067|-0.31026|0.0277
91636046|NCT01014442|183164203|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0035||||0.0002|TWO_SIDED|95.0|-0.00476|0.00168|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00168|-0.00476|0.0002
91669479|NCT04010227|183233675|SUPERIORITY||partial correlation|0.13||||0.29|TWO_SIDED|95.0|-0.19|0.44||P-value for study group x time interaction for patient social quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.44|-0.19|0.29
91669480|NCT04010227|183233676|SUPERIORITY||partial correlation|0.03||||0.92|TWO_SIDED|95.0|-0.28|0.35||P-value for study group x time interaction for caregiver physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.35|-0.28|0.92
91669481|NCT04010227|183233676|SUPERIORITY||partial correlation|0.06||||0.79|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for caregiver psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.79
91669482|NCT04010227|183233677|SUPERIORITY||partial correlation|0.02||||0.94|TWO_SIDED|95.0|-0.3|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.30|0.94
91669483|NCT00702507|183233693|SUPERIORITY_OR_OTHER||Percentage of participants|29.2|||||TWO_SIDED|95.0|22.4|36.7|||||Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population|||36.7|22.4|
91669484|NCT00781079|183233732|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Models included site, age, race, ethnicity.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.5
91669485|NCT00781079|183233733|SUPERIORITY||Z tests if Reg coeff are diff from 0|-0.58||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
91669486|NCT00781079|183233734|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Models included site, age, race, ethnicity. This is the calculated p value.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.05
91669487|NCT00781079|183233735|SUPERIORITY||Z test if reg coeff is diff from 0|0.56||||0.58|TWO_SIDED||||||Regression, Linear|||||||.58
91669488|NCT00781079|183233736|SUPERIORITY||Z test if reg coeff is diff than 0|-0.16||||0.87|TWO_SIDED||||||Regression, Linear|||||||.87
91669489|NCT00781079|183233737|SUPERIORITY||Z test if ref coeff is diff than 0|0.03||||0.98|TWO_SIDED||||||Regression, Linear|||||||.98
91714928|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|-0.35|||||TWO_SIDED|95.0|-1.55|0.85|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.85|-1.55|
91636047|NCT01014442|183164203|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000138||||0.1661|TWO_SIDED|95.0|-0.0000295|0.0000047|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000047|-0.0000295|0.1661
91636048|NCT01014442|183164204|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00054||||0.9417|TWO_SIDED|95.0|-0.01037|0.01042|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01042|-0.01037|0.9417
91636049|NCT01014442|183164204|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1461||||0.2941|TWO_SIDED|95.0|-0.39951|0.12988|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.12988|-0.39951|0.2941
91636050|NCT01014442|183164204|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00033||||0.817|TWO_SIDED|95.0|-0.00361|0.00421|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00421|-0.00361|0.8170
91636051|NCT01014442|183164204|SUPERIORITY_OR_OTHER||Hodge-Lehmann estimator|-0.0000239||||0.1927|TWO_SIDED|95.0|-0.0000594|0.0000154|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000154|-0.0000594|0.1927
91636052|NCT01014442|183164205|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1616||||0.0821|TWO_SIDED|95.0|-0.0121|0.4188|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4188|-0.0121|0.0821
91669490|NCT04254809|183233738|SUPERIORITY||Slope|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.02|-0.25||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regressing scores at one-week follow-up onto scores at baseline.||-0.25|-1.02|.001
91636053|NCT01014442|183164206|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0427||||0.3628|TWO_SIDED|95.0|-0.0455|0.1221|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1221|-0.0455|0.3628
91636054|NCT01014442|183164207|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.001||||0.9873|TWO_SIDED|95.0|-0.1152|0.1173|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1173|-0.1152|0.9873
91636055|NCT01014442|183164208|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0857||||0.2178|TWO_SIDED|95.0|-0.187|0.0265|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0265|-0.1870|0.2178
91636056|NCT01014442|183164214|SUPERIORITY_OR_OTHER||Difference in rates|-1.8||||1|TWO_SIDED|95.0|-24.9|22.1|||Fisher Exact|||||22.1|-24.9|1.0000
91636057|NCT00147082|183164238|SUPERIORITY|||||||0.05||||||The threshold for significance was p\<0.05|Kruskal-Wallis|||p values were calculated||||0.05
91636058|NCT00147082|183164239|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||p value was calculated||||0.05
91636059|NCT00147082|183164240|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||The p value was calculated||||0.05
91636060|NCT02242305|183164241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.809|TWO_SIDED|90.0|-0.33|0.27|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.27|-0.33|0.809
91636061|NCT02242305|183164241|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.809|TWO_SIDED|95.0|-0.39|0.33|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.33|-0.39|0.809
91636062|NCT02242305|183164242|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.||||||0.079
91669491|NCT04254809|183233739|SUPERIORITY||Slope|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.99|-0.23||Threshold for significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-month follow-up onto scores at baseline.||-0.23|-0.99|.002
91636063|NCT02242305|183164247|SUPERIORITY_OR_OTHER|||||||0.531|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.||||||0.531
91636064|NCT03547960|183164248|SUPERIORITY|||||||0.639|||||||Chi-squared|||||||0.639
91636065|NCT03547960|183164248|SUPERIORITY|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||||||0.283
91669492|NCT04254809|183233740|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.86|-0.05||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as -, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL.|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-week follow-up onto scores at baseline.||-.05|-0.86|.03
91669493|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.38|0.35||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.35|-0.38|
91525966|NCT03502616|182927257|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.423|<|0.0001|TWO_SIDED|95.0|1.35|3.02|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|1.35|<0.0001
91669494|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.6|0.13||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.60|
91669495|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.7|0.15||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.70|
91669496|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.93|-0.07||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.93|
91669497|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.69|0.33||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.33|-0.69|
91669498|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.09|-0.06||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.06|-1.09|
91669499|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.94|0.27||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.27|-0.94|
91669500|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.21|0.0||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.00|-1.21|
91669501|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.24|-0.03||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-1.24|
91669502|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.84|0.38||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.38|-0.84|
91669503|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.53|0.01||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.01|-1.53|
91669504|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.07|0.47||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.47|-1.07|
91669505|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.65|-0.08||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-1.65|
91669506|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.06|0.55||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.55|-1.06|
91714929|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|-0.7|||||TWO_SIDED|95.0|-1.6|0.2|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.20|-1.60|
91485174|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
91636066|NCT03547960|183164250|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
91485175|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.091|TWO_SIDED|95.0|-0.23|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.23|0.091
91636067|NCT02532998|183164251|SUPERIORITY_OR_OTHER||Treatment differences|-1.258|||||TWO_SIDED|90.0|-1.721|0.7945|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment C and Treatment D.||0.7945|-1.721|
91636068|NCT02532998|183164266|SUPERIORITY_OR_OTHER||Treatment differences|3.409|||||TWO_SIDED|90.0|2.946|3.872|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment A and Treatment B.||3.872|2.946|
91636069|NCT02625610|183164299|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1779|TWO_SIDED|95.0|0.74|1.11|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.11|0.74|0.1779
91636070|NCT02625610|183164300|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
91636071|NCT02625610|183164302|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.55|1.51||||||||1.51|0.55|
91636072|NCT03459794|183164312|OTHER|||||||||||||||||All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =\<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.|||
91636073|NCT03459794|183164313|OTHER|||||||||||||||||All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=\<0.05.|||
91636074|NCT03459794|183164314|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91636075|NCT00352027|183164316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||The association of age with EFS was compared. P values from Score test were computed for the statistical significance.||||0.9970
91636076|NCT00352027|183164319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||||||0.9970
91636077|NCT00352027|183164351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.265
91636078|NCT00352027|183164351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.057
91636079|NCT00352027|183164351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.079
91636080|NCT00352027|183164351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
91636081|NCT00352027|183164351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.680
91636082|NCT00352027|183164352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
91636083|NCT00352027|183164352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
91636084|NCT00352027|183164352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
91636085|NCT00352027|183164352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.184
91636086|NCT00352027|183164352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
91636087|NCT00352027|183164353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.319||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.319
91636088|NCT00352027|183164353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.010
91636089|NCT00352027|183164353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.002
91636090|NCT00352027|183164353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.015
91636091|NCT00352027|183164353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.588
91636092|NCT00352027|183164354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.071
91636093|NCT00352027|183164354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
91636094|NCT00352027|183164354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
91669507|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.72|-0.15||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.72|
91669508|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.05|0.54||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.54|-1.05|
91669509|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.15||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.80|
91669510|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.04|0.61||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.61|-1.04|
91669511|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.65|-0.05||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.05|-1.65|
91669512|NCT02725411|183233786|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.88|0.71||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.71|-0.88|
91669513|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.77|0.04||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.04|-1.77|
91669514|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.96|-0.14||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||-0.14|-1.96|
91525967|NCT03502616|182927257|SUPERIORITY||LS mean difference|1.98|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|1.11|2.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.11|<0.0001
91669515|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.48|0.43||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.43|-1.48|
91669516|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.43|0.51||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.51|-1.43|
91669517|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.04|0.91||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.91|-1.04|
91669518|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.53|0.44||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.44|-1.53|
91669519|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.06|1.05||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.05|-1.06|
91669520|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.6|0.53||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.53|-1.60|
91669521|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.71|0.88||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.88|-1.71|
91669522|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.47|1.14||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.14|-1.47|
91669523|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.9|0.71||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.71|-1.90|
91669524|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.44|1.25||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.25|-1.44|
91669525|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.43|0.28||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.28|-2.43|
91669526|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.41|1.32||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.32|-1.41|
91669527|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.17|0.57||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.57|-2.17|
91669528|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.16|1.64||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.64|-1.16|
91714930|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|0.0|||||TWO_SIDED|95.0|-0.31|0.31|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.31|
91714931|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
91714932|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
91714933|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|0.26|||||TWO_SIDED|95.0|-0.44|0.96|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.96|-0.44|
91669529|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.37|0.35||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.35|-2.37|
91669530|NCT02725411|183233788|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.35|1.42||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.42|-1.35|
91669531|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|13.0|||||TWO_SIDED|95.0|-0.8|26.3||||||Week 16: \>=30%||26.3|-0.8|
91669532|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.7|||||TWO_SIDED|95.0|-15.8|12.4||||||Week 16: \>=30%||12.4|-15.8|
91669533|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|4.2|32.0||||||Week 16: \>=50%||32.0|4.2|
91669534|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.9|||||TWO_SIDED|95.0|-10.7|16.3||||||Week 16: \>=50%||16.3|-10.7|
91669535|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.9|||||TWO_SIDED|95.0|0.6|20.7||||||Week 16: \>=70%||20.7|0.6|
91669536|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.5|||||TWO_SIDED|95.0|-1.4|18.1||||||Week 16: \>=70%||18.1|-1.4|
91669537|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-4.3|6.5||||||Week 16: \>=90%||6.5|-4.3|
91714934|NCT01705977|183321114|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
91714935|NCT01705977|183321116|OTHER||Difference in percentage versus placebo|-0.45|||||TWO_SIDED|95.0|-1.03|0.13|||||95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.13|-1.03|
91714936|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|-0.75|||||TWO_SIDED|95.0|-2.02|0.51|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-2.02|
91714937|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|-1.0|||||TWO_SIDED|95.0|-1.96|-0.04|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||-0.04|-1.96|
91714938|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|-0.1|||||TWO_SIDED|95.0|-0.44|0.24|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.24|-0.44|
91714939|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
91714940|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
91636095|NCT00352027|183164354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
91636096|NCT00352027|183164354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.707
91636097|NCT00352027|183164355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.042
91636098|NCT00352027|183164355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
91636099|NCT00352027|183164355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.013
91636100|NCT00352027|183164355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.027
91636101|NCT00352027|183164355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.243
91636102|NCT00352027|183164356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.546
91636103|NCT00352027|183164356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.242
91636104|NCT00352027|183164356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
91636105|NCT00352027|183164356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.503
91636106|NCT00352027|183164356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
91636107|NCT00352027|183164357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.558
91636108|NCT00352027|183164357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.039
91669538|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.1|||||TWO_SIDED|95.0|-3.7|7.8||||||Week 16: \>=90%||7.8|-3.7|
91669539|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.3|25.7||||||Week 24: \>=30%||25.7|-2.3|
91669540|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.6|||||TWO_SIDED|95.0|-15.9|12.6||||||Week 24: \>=30%||12.6|-15.9|
91669541|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 24: \>=50%||25.8|-2.4|
91669542|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.1|18.9||||||Week 24: \>=50%||18.9|-9.1|
91636109|NCT00352027|183164357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
91636110|NCT00352027|183164357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
91636111|NCT00352027|183164358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.381
91636112|NCT00352027|183164358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.006
91636113|NCT00352027|183164358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.277
91636114|NCT00352027|183164358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.134||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.134
91636115|NCT00352027|183164359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
91636116|NCT00352027|183164359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
91636117|NCT00352027|183164359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
91636118|NCT00352027|183164359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.858||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.858
91636119|NCT00352027|183164360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.744
91636120|NCT00352027|183164360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.075
91636121|NCT00352027|183164360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.512
91636122|NCT00352027|183164360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.088
91636123|NCT00352027|183164361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
91636124|NCT00352027|183164361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.041
91669543|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|14.1|||||TWO_SIDED|95.0|2.9|24.8||||||Week 24: \>=70%||24.8|2.9|
91636125|NCT00352027|183164361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
91636126|NCT00352027|183164361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
91636127|NCT00352027|183164362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
91636128|NCT00352027|183164362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
91636129|NCT00352027|183164362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
91636130|NCT00352027|183164362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
91636131|NCT00352027|183164363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
91636132|NCT00352027|183164363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
91636133|NCT00352027|183164363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.051
91669544|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.6|||||TWO_SIDED|95.0|-0.2|21.0||||||Week 24: \>=70%||21.0|-0.2|
91669545|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.7|11.4||||||Week 24: \>=90%||11.4|-0.7|
91669546|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 24: \>=90%||8.5|-2.2|
91636134|NCT00352027|183164363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0779||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.0779
91636135|NCT00352027|183164364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.415
91636136|NCT00352027|183164364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
91636137|NCT00352027|183164364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.245
91636138|NCT00352027|183164364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
91636139|NCT00352027|183164365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.814
91636140|NCT00352027|183164365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.553||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.553
91636141|NCT00352027|183164365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.173
91636142|NCT00352027|183164365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.122
91636143|NCT00352027|183164366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636144|NCT00352027|183164367|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
91636145|NCT00352027|183164368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
91636146|NCT00352027|183164369|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
91636147|NCT00352027|183164370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
91636148|NCT00352027|183164371|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
91636149|NCT00352027|183164372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636150|NCT00352027|183164373|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636151|NCT00352027|183164374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636152|NCT00352027|183164375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Generalized Estimating Equations (GEE)|||||||0.005
91636153|NCT00352027|183164376|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636154|NCT00352027|183164377|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636155|NCT00352027|183164378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636156|NCT00352027|183164379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636157|NCT00352027|183164380|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
91636158|NCT00352027|183164381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.908|||||||Log Rank|||||||0.908
91636159|NCT00352027|183164382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||Log Rank|||||||0.178
91636160|NCT00352027|183164383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|||||||Log Rank|||||||0.411
91636161|NCT00352027|183164385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4318|||||||Cox Model|||||||0.4318
91636162|NCT00352027|183164386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|||||||Cox Model|||||||0.2199
91636163|NCT00352027|183164387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8946|||||||Cox Model|||||||0.8946
91636164|NCT02607735|183164423|SUPERIORITY|The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|||||<|0.001|||||||2-sided exact 1-sample binomial test|||||||<0.001
91636165|NCT02430389|183164455|SUPERIORITY_OR_OTHER|||||||0.0575|TWO_SIDED||||||t-test, 2 sided|||||||.0575
91636166|NCT02430389|183164456|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
91636167|NCT02394028|183164470|SUPERIORITY||Difference in rate|1.1||||0.8508|TWO_SIDED|95.0|-10.85|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-10.85|0.8508
91636168|NCT02394028|183164470|SUPERIORITY||Difference in rate|3.8||||0.5235|TWO_SIDED|95.0|-8.3|15.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.27|-8.30|0.5235
91636169|NCT02394028|183164472|SUPERIORITY||Difference in rate|4.9||||0.7908|TWO_SIDED|95.0|-6.26|16.11||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||16.11|-6.26|0.7908
91636170|NCT02394028|183164472|SUPERIORITY||Difference in rate|5.8||||0.317|TWO_SIDED|95.0|-5.43|17.05||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||17.05|-5.43|0.3170
91636171|NCT02394028|183164473|SUPERIORITY||Difference in rate|11.3||||0.0088|TWO_SIDED|95.0|2.7|19.65||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.65|2.70|0.0088
91636172|NCT02394028|183164474|SUPERIORITY||Difference in rate|11.5||||0.0026|TWO_SIDED|95.0|4.11|18.83||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||18.83|4.11|0.0026
91636173|NCT02394028|183164476|SUPERIORITY||Difference in rate|3.1||||1|TWO_SIDED|95.0|-8.02|13.45||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||13.45|-8.02|1
91636174|NCT02394028|183164476|SUPERIORITY||Difference in rate|2.3||||0.7908|TWO_SIDED|95.0|-8.78|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-8.78|0.7908
91636175|NCT02394028|183164478|SUPERIORITY||Difference in rate|1.6||||1|TWO_SIDED|95.0|-6.51|9.73||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||9.73|-6.51|1
91636176|NCT02394028|183164478|SUPERIORITY||Difference in rate|6.5||||0.5235|TWO_SIDED|95.0|-2.24|15.16||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.16|-2.24|0.5235
91669547|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.1|30.9||||||Week 40: \>=30%||30.9|3.1|
91669548|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-0.5|||||TWO_SIDED|95.0|-14.8|13.7||||||Week 40: \>=30%||13.7|-14.8|
91669549|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.0|31.0||||||Week 40: \>=50%||31.0|3.0|
91636177|NCT02394028|183164479|SUPERIORITY||Difference in LSM|-0.5||||0.311|TWO_SIDED|90.0|-1.4|0.3|||MMRM|||Bowel Domain Score||0.3|-1.4|0.3110
91636178|NCT02394028|183164480|SUPERIORITY||Difference in LSM|0.2||||1|TWO_SIDED|95.0|-0.5|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Scale||0.9|-0.5|1
91636179|NCT02394028|183164480|SUPERIORITY||Difference in LSM|0.0||||1|TWO_SIDED|95.0|-0.7|0.7||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Score||0.7|-0.7|1
91636180|NCT02394028|183164480|SUPERIORITY||Difference in LSM|0.1||||1|TWO_SIDED|95.0|-0.8|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.9|-0.8|1
91636181|NCT02394028|183164480|SUPERIORITY||Difference in LSM|-0.3||||1|TWO_SIDED|95.0|-1.1|0.5||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.5|-1.1|1
91636182|NCT02394028|183164481|SUPERIORITY||Difference in rate|17.3||||0.0677|TWO_SIDED|95.0|3.52|30.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||30.27|3.52|0.0677
91636183|NCT02394028|183164482|SUPERIORITY||Difference in rates|18.6||||0.048|TWO_SIDED|95.0|11.07|25.96||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||25.96|11.07|0.0480
91636184|NCT02394028|183164483|SUPERIORITY||Difference in rates|13.5||||0.121|TWO_SIDED|95.0|-2.9|29.94|||Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||29.94|-2.90|0.1210
91636185|NCT02394028|183164484|SUPERIORITY||Difference in rates|6.2||||0.048|TWO_SIDED|95.0|0.54|11.93||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||11.93|0.54|0.0480
91636186|NCT02394028|183164485|SUPERIORITY||Difference in rates|11.2||||0.0677|TWO_SIDED|95.0|3.04|19.24||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.24|3.04|0.0677
91636187|NCT02394028|183164486|SUPERIORITY||Difference in rates|16.2||||0.0035|TWO_SIDED|95.0|8.96|23.31||Nominal p-value, no adjustment for multiplicity performed.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||23.31|8.96|0.0035
91636188|NCT02394028|183164487|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-0.9|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Functional Symptoms Domain||0.4|-0.9|0.4009
91636189|NCT02394028|183164487|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-1.0|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Symptoms Domain||0.4|-1.0|0.4009
91792690|NCT01293799|183463103|OTHER||Hazard Ratio (HR)|0.92||||0.71|TWO_SIDED|95.0|0.58|1.45||"Unit of measure: Other Diagnosis as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant."|Regression, Cox|Univariable Cox regression||"The association of Other Diagnosis as primary cause of kidney failure (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.45|0.58|0.71
91636190|NCT00742391|183164497|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91636191|NCT00742391|183164498|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
91636192|NCT02109939|183164528|SUPERIORITY||Mean Difference (Net)|-2.836|STANDARD_ERROR_OF_MEAN|1.758||0.107|TWO_SIDED|95.0|-6.285|0.613|||Mixed Models Analysis|Repeated Measures including week 4.||||0.613|-6.285|0.1070
91636193|NCT02109939|183164529|SUPERIORITY||Mean Difference (Net)|-2.207|STANDARD_ERROR_OF_MEAN|1.653||0.1822|TWO_SIDED|95.0|-5.45|1.036|||Mixed Models Analysis|MMRM with week 4 data.||||1.036|-5.450|0.1822
91636194|NCT02109939|183164530|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0134|TWO_SIDED|95.0|1.07|1.86|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.86|1.07|0.0134
91636195|NCT02109939|183164533|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0066|TWO_SIDED|95.0|1.14|2.27|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||2.27|1.14|0.0066
91636196|NCT02109939|183164536|SUPERIORITY||Odds Ratio (OR)|1.13||||0.2852|TWO_SIDED|95.0|0.9|1.43|||Generalized linear mixed model.|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.43|0.90|0.2852
91636197|NCT02109939|183164537|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0023|TWO_SIDED|95.0|1.14|1.79|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.79|1.14|0.0023
91636198|NCT02109939|183164546|SUPERIORITY||Odds Ratio (OR)|1.43||||0.014|TWO_SIDED|95.0|1.07|1.89|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.89|1.07|0.0140
91636199|NCT02109939|183164547|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0663|TWO_SIDED|95.0|0.98|1.76|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.76|0.98|0.0663
91636200|NCT01058356|183164554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.4|<|0.05|TWO_SIDED|95.0|0.17|4.15|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||4.15|0.17|<0.05
91636201|NCT01058356|183164555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.18|1.55|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||1.55|0.18|<0.05
91636202|NCT00606021|183164571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.1815|TWO_SIDED|95.0|0.42|1.37||The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.37|0.42|0.1815
91636203|NCT00606021|183164572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.1233|TWO_SIDED|95.0|0.4|1.26||The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.26|0.40|0.1233
91636204|NCT00606021|183164573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7239|TWO_SIDED|95.0|0.56|2.28||The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.28|0.56|0.7239
91636205|NCT00606021|183164574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.6376|TWO_SIDED|95.0|0.59|2.38||The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.38|0.59|0.6376
91636206|NCT03198884|183164591|OTHER|The percent of patients with an RNA \<50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. Change in mean serum creatinine from baseline was analyzed using Wilcoxon signed rank test.|||||<|0.05|||||||McNemar||||Change in mean CD4+ cell counts from baseline was analyzed using a paired t-test. All analyses used a p-value of less than or equal to 0.05 as significant. Statistical analyses were performed using R software, version 3.4.3.|||<0.05
91636207|NCT03198884|183164592|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91636208|NCT01202643|183164598|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|||||||0.67
91636209|NCT01202643|183164599|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared, Corrected|||Study was closed due to insufficient recruitment||||0.74
91636210|NCT00989664|183164605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||||||<0.001
91636211|NCT00692198|183164637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.79|1.12|||Log Rank|||||1.12|0.79|0.52
91714941|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|0.31|||||TWO_SIDED|95.0|-0.42|1.05|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||1.05|-0.42|
91714942|NCT01705977|183321117|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
91714943|NCT01705977|183321119|OTHER||Odds ratio versus placebo|1.3||||0.0284|TWO_SIDED|95.0|1.03|1.65|||Regression, Logistic||95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (\<=9 versus \>=10) and region|||1.65|1.03|0.0284
91714944|NCT00248651|183321127|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of \<0.05 was considered statistically significant.||||0.05
91792691|NCT01293799|183463104|OTHER||Hazard Ratio (HR)|1.04||||0.89|TWO_SIDED|95.0|0.57|1.91||Unit of measure: Unknown cause as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Unknown Primary Cause of Kidney Failure as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression."||1.91|0.57|0.89
91636212|NCT00692198|183164638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.53|TWO_SIDED|95.0|0.64|1.25|||Log Rank||Hazard ratio, LTOT vs No LTOT|||1.25|0.64|0.53
91636213|NCT00692198|183164639|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.81|TWO_SIDED|95.0|0.91|1.13|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.13|0.91|0.81
91636214|NCT00692198|183164641|SUPERIORITY_OR_OTHER||Rate ratio|1.08||||0.12|TWO_SIDED|95.0|0.98|1.19|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.19|0.98|0.12
91636215|NCT00692198|183164642|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
91636216|NCT00692198|183164643|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
91636217|NCT00692198|183164644|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
91636218|NCT00692198|183164645|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
91636219|NCT00692198|183164646|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
91636220|NCT00692198|183164647|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
91636221|NCT00692198|183164648|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|||||TWO_SIDED|95.0|0.54|8.0|||||Relative risk, LTOT vs No LTOT|||8.00|0.54|
91636222|NCT00692198|183164649|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
91636223|NCT00692198|183164650|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
91636224|NCT03330275|183164651|NON_INFERIORITY|A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.|Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.0574|||TWO_SIDED|95.0|-0.045|0.183|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Mean difference was calculated as Test - Control 1|It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.||0.183|-0.045|
91636225|NCT03330275|183164652|NON_INFERIORITY|A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.|Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0076|||TWO_SIDED|95.0|-0.043|-0.012|||Linear Mixed Model|Kenward and Roger Method was used for the degrees of freedom.|Mean difference was calculated as Test - Control 1|||-0.012|-0.043|
91636226|NCT03330275|183164653|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|3.162|||||TWO_SIDED|95.0|0.442|22.604|||Generalized Estimating Equation||Odds ratio was calculated as Test over Control 1|||22.604|0.442|
91636227|NCT03330275|183164654|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.82|1.16|||Generalized Linear Mixed Model||Odds ratio was calculated as Test over Control1|||1.16|0.82|
91636228|NCT03330275|183164655|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|5.29|||TWO_SIDED|95.0|7.1|28.5|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control 1|||28.5|7.1|
91636229|NCT03330275|183164656|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.33|1.74|||Generalized Linear Mixed Model||Odds Ratio was calculated as Test over Control 1|||1.74|0.33|
91636230|NCT03330275|183164657|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|7.93|||TWO_SIDED|95.0|-11.4|20.7|||Linear Mixed Model|Kenward and Roger Method was used for denominator Degrees of Freedom.|Mean difference was calculated as Test - Control 1|||20.7|-11.4|
91636231|NCT02577107|183164666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.314|STANDARD_ERROR_OF_MEAN|4.1613|||TWO_SIDED|95.0|9.618|31.011||||||||31.011|9.618|
91636232|NCT02988115|183164688|SUPERIORITY||Least squares means difference|-21.41|STANDARD_ERROR_OF_MEAN|1.897|<|0.001|TWO_SIDED|95.0|-25.132|-17.697|||ANCOVA||bempedoic acid (BA) therapy minus placebo|||-17.697|-25.132|<0.001
91636233|NCT02988115|183164689|SUPERIORITY||Least squares means difference|-18.91|STANDARD_ERROR_OF_MEAN|2.063|<|0.001|TWO_SIDED|95.0|-22.951|-14.865|||ANCOVA||BA therapy minus placebo|||-14.865|-22.951|<0.001
91636234|NCT02988115|183164690|SUPERIORITY||Least squares means difference|-17.94|STANDARD_ERROR_OF_MEAN|1.597|<|0.001|TWO_SIDED|95.0|-21.07|-14.811|||ANCOVA||BA therapy minus placebo|non-HDL-C||-14.811|-21.070|<0.001
91636235|NCT02988115|183164690|SUPERIORITY||Least squares means difference|-14.76|STANDARD_ERROR_OF_MEAN|1.287|<|0.001|TWO_SIDED|95.0|-17.283|-12.239|||ANCOVA||BA therapy minus placebo|TC||-12.239|-17.283|<0.001
91636236|NCT02988115|183164690|SUPERIORITY||Least squares means difference|-14.96|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-18.062|-11.866|||ANCOVA||BA therapy minus placebo|apoB||-11.866|-18.062|<0.001
91636237|NCT02988115|183164691|SUPERIORITY||Median treatment difference|-24.29|STANDARD_ERROR_OF_MEAN|-24.3|<|0.001|TWO_SIDED|95.0|-35.888|-12.712|||Wilcoxon rank sum test||BA therapy minus placebo|||-12.712|-35.888|<0.001
91636238|NCT00649220|183164743|SUPERIORITY_OR_OTHER|||||||0.22626||95.0|||||t-test, 2 sided|||Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.22626
91669550|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.0|18.7||||||Week 40: \>=50%||18.7|-9.0|
91636239|NCT00649220|183164743|SUPERIORITY_OR_OTHER|||||||0.34192||95.0|||||Wilcoxon signed rank test|||Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.34192
91636240|NCT04594213|183164759|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91669551|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|4.6|29.4||||||Week 40: \>=70%||29.4|4.6|
91669552|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.3|||||TWO_SIDED|95.0|-4.5|18.9||||||Week 40: \>=70%||18.9|-4.5|
91669553|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.6|||||TWO_SIDED|95.0|1.4|13.5||||||Week 40: \>=90%||13.5|1.4|
91669554|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.1|10.6||||||Week 40: \>=90%||10.6|-0.1|
91669555|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 56: \>=30%||25.8|-2.4|
91636241|NCT04594213|183164760|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91669556|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-3.8|||||TWO_SIDED|95.0|-17.9|10.5||||||Week 56: \>=30%||10.5|-17.9|
91669557|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.5|25.9||||||Week 56: \>=50%||25.9|-2.5|
91669558|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-2.6|||||TWO_SIDED|95.0|-16.5|11.4||||||Week 56: \>=50%||11.4|-16.5|
91669559|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|5.6|30.5||||||Week 56: \>=70%||30.5|5.6|
91669560|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.4|||||TWO_SIDED|95.0|-3.6|20.0||||||Week 56: \>=70%||20.0|-3.6|
91669561|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.7|||||TWO_SIDED|95.0|1.6|15.4||||||Week 56: \>=90%||15.4|1.6|
91669562|NCT02725411|183233792|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 56: \>=90%||8.5|-2.2|
91669563|NCT02725411|183233808|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||95% CI of proportion is the Agresti-Coull confidence limit.||4.1|-4.1|
91669564|NCT02725411|183233808|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||95% CI of proportion is the Agresti-Coull confidence limit.||8.5|-2.2|
91669565|NCT02418754|183233859|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.58||||0.2052|TWO_SIDED|95.0|-4.37|1.22||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||1.22|-4.37|0.2052
91669566|NCT02418754|183233859|SUPERIORITY|Analysis was performed using ANCOVA model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.7||||0.0982|TWO_SIDED|95.0|-4.0|0.61||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||0.61|-4.00|0.0982
91669567|NCT00462839|183233867|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.|ANOVA|||Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.||||<0.05
91669568|NCT00462839|183233868|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared, Corrected|||||||0.76
91669569|NCT00462839|183233869|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared, Corrected|||||||0.72
91669570|NCT00462839|183233870|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared, Corrected|||||||0.89
91669571|NCT04784637|183233872|SUPERIORITY|||||||0.064|||||||t-test, 2 sided|||||||0.064
91669572|NCT04784637|183233872|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91669573|NCT04784637|183233873|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91636242|NCT04594213|183164761|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636243|NCT04594213|183164762|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636244|NCT04594213|183164763|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636245|NCT04594213|183164764|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636246|NCT04594213|183164765|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636247|NCT04594213|183164766|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636248|NCT04594213|183164767|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636249|NCT04594213|183164768|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91636250|NCT04594213|183164769|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636251|NCT04594213|183164769|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636252|NCT04594213|183164770|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636253|NCT04594213|183164770|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636254|NCT04594213|183164771|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91636255|NCT04594213|183164772|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91636256|NCT04594213|183164772|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91669574|NCT04784637|183233873|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
91669575|NCT05103657|183233892|OTHER||Mean Difference (Net)|0.06||||0.9726|TWO_SIDED|95.0|-3.31|3.43|||Mixed Models for repeated measures||"Least Squares mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Squares (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||3.43|-3.31|0.9726
91669576|NCT05103657|183233893|OTHER||Odds Ratio (OR)|1.002||||0.9945|TWO_SIDED|95.0|0.608|1.65|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.650|0.608|0.9945
91669577|NCT05103657|183233894|OTHER||Odds Ratio (OR)|0.912||||0.7167|TWO_SIDED|95.0|0.552|1.504|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.504|0.552|0.7167
91669578|NCT05103657|183233895|OTHER||Mean Difference (Net)|0.66||||0.723|TWO_SIDED|95.0|-3.0|4.32|||Mixed Models for Repeated Measures||"Least Square mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Square (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||4.32|-3.00|0.7230
91669579|NCT02020967|183233900|OTHER||Odds Ratio (OR)|7.34||||0.0196|TWO_SIDED|95.0|1.38|39.11|||Regression, Logistic|||Predictor variable: Lips enlargement||39.11|1.38|0.0196
91669580|NCT01160640|183233915|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value for proportion of women who had clearance of anaerobic organisms from the endometrium at the 30-day visit|Fisher Exact|||||||0.046
91669581|NCT01160640|183233917|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value for proportion of women who did not have M. genitalium detected in the cervix or endometrium at the 30-day visit|Fisher Exact|||||||0.16
91525968|NCT03502616|182927257|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.454||0.0007|TWO_SIDED|95.0|0.67|2.45|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.67|0.0007
91669582|NCT01160640|183233918|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value for proportion of women who experienced resolution of clinical signs and symptoms of PID at the 3-day visit|Fisher Exact|||||||0.74
91669583|NCT01525628|183233928|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|251.37|STANDARD_DEVIATION|31.0||1|TWO_SIDED|90.0|205.54|307.43|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||307.43|205.54|1.0000
91669584|NCT01525628|183233928|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|131.3|STANDARD_DEVIATION|32.5||0.6514|TWO_SIDED|90.0|105.4|163.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||163.57|105.40|0.6514
91669585|NCT01525628|183233929|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|381.11|STANDARD_DEVIATION|28.1||1|TWO_SIDED|90.0|317.01|458.19|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||458.19|317.01|1.0000
91669586|NCT01525628|183233929|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|123.65|STANDARD_DEVIATION|40.0||0.4718|TWO_SIDED|90.0|94.66|161.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.51|94.66|0.4718
91669587|NCT01525628|183233930|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|306.45|STANDARD_DEVIATION|30.7||1|TWO_SIDED|90.0|250.93|374.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||374.26|250.93|1.0000
91714945|NCT00248651|183321130|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||Comparison between antidepressant arms and placebo for overall quality of life. A p-value of \<0.05 was considered statistically significant.||||0.02
91525969|NCT03502616|182927257|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.485||0.2018|TWO_SIDED|95.0|-0.33|1.58|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.58|-0.33|0.2018
91714946|NCT00248651|183321130|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
91714947|NCT00248651|183321130|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Interference subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
91525970|NCT03502616|182927257|SUPERIORITY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.465||0.6432|TWO_SIDED|95.0|-0.7|1.13|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.13|-0.70|0.6432
91636257|NCT00104299|183164782|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of -20%|Difference between group success rates|10.6|||<|0.001||95.1|-3.2|24.3||P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.|95.1% CI of difference|Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.||In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.||24.3|-3.2|<0.001
91636258|NCT00104299|183164783|SUPERIORITY_OR_OTHER|||||||0.927||||||P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model|Poisson regression model|||Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.||||0.927
91636259|NCT00104299|183164784|SUPERIORITY_OR_OTHER||95.1% Confidence Interval of Difference|10.6||||0.133|TWO_SIDED|95.1|-3.2|24.4|||Chi-squared|At 6 months, the confidence interval is 95.1%.||The p-value is from a chi-square test.||24.4|-3.2|0.133
91636260|NCT00104299|183164785|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.761|TWO_SIDED|95.0|0.5|1.7||The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission|Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.7|0.5|0.761
91636261|NCT00104299|183164786|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.861|TWO_SIDED|95.0|0.6|1.5|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.5|0.6|0.861
91636262|NCT00104299|183164787|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.497|TWO_SIDED|95.0|0.7|1.3|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.3|0.7|0.497
91636263|NCT00104299|183164788|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.147|TWO_SIDED|95.0|0.9|1.8|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.8|0.9|0.147
91636264|NCT00104299|183164789|SUPERIORITY_OR_OTHER|||||||0.504||95.0|||||Chi-squared|||Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.||||0.504
91636265|NCT04646668|183164798|SUPERIORITY|Due to the pilot nature of the current study, formal power calculations were not conducted.||||||0.002|||||||ANOVA|||The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).||||0.002
91636266|NCT03288987|183164804|NON_INFERIORITY|Noninferiority was declared by comparing the 90% CI for the hazard ratio (HR) of the AryoGen Pharmed Bevacizumab to the reference product (Roche Bevacizumab) to the point-estimate margin and was based on the synthesis method.|Hazard Ratio (HR)|0.79||||0.47|TWO_SIDED|90.0|0.46|1.35|||Regression, Cox|Upper limit of CI is lower than the noninferiority margin (1.44).|The 90 % CI based on synthesis method is (0.45,1.38). In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.35|0.46|0.47
91636267|NCT03288987|183164805|OTHER||Hazard Ratio (HR)|0.99||||0.99|TWO_SIDED|95.0|0.55|1.8|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.80|0.55|0.99
91636268|NCT03288987|183164806|OTHER|||||||0.17|||||||Fisher's Exact Test|||||||0.17
91636269|NCT03288987|183164807|OTHER||Hazard Ratio (HR)|1.11||||0.59|TWO_SIDED|95.0|0.76|1.61|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.61|0.76|0.59
91636270|NCT03288987|183164808|OTHER||||||>|0.05|||||||Fisher's Exact Test|||||||>0.05
91636271|NCT00608426|183164810|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||||||.02
91636272|NCT00608426|183164811|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of telephone counseling between the two groups|Mixed effects logistic regression|||||||<.001
91636273|NCT00608426|183164811|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|||||for the comparison of in-person counseling between the two groups|Mixed effects logistic regression|||||||0.57
91636274|NCT00608426|183164811|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||for the comparison of used medications between the two groups|Mixed effects logistic regression|||||||.15
91636275|NCT00608426|183164811|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of combination counseling and medication between the two groups|Mixed effects logistic regression|||||||<.001
91792692|NCT01293799|183463105|OTHER||Hazard Ratio (HR)|1.16||||0.28|TWO_SIDED|95.0|0.88|1.53||Unit of measure: Comorbidity at PD start according to Stoke comorbidity score (1-2 vs. 0) i.e. 1-2 comorbidities vs. no comorbidity. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Comorbidity according to Stoke comorbidity score with time to first peritonitis episode was analysed by univariable Cox regression."||1.53|0.88|0.28
91792693|NCT01293799|183463105|OTHER||Hazard Ratio (HR)|1.29||||0.44|TWO_SIDED|95.0|0.68|2.45||Unit of measure: Comorbidity at PD start according to Stoke comorbidity score (\>2 vs. 0) i.e. more than 2 comorbidities vs. no comorbidity. P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Comorbidity according to Stoke comorbidity score with time to first peritonitis episode was analysed by univariable Cox regression."||2.45|0.68|0.44
91636276|NCT00608426|183164811|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||for the comparison of attended VA smoking cessation clinic between the two groups|Mixed effects logistic regression|||||||.77
91636277|NCT00608426|183164811|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||for the comparison of received VA smoking cessation medication between the two groups|Mixed effects logistic regression|||||||.002
91636278|NCT00608426|183164812|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Regression, Logistic|||||||0.13
91636279|NCT00368069|183164815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.155||||0.038||95.0|0.009|0.301|||ANCOVA|Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.||||0.301|0.009|0.038
91636280|NCT00368069|183164815|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.4||||||95.0|0.9|26.0|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.0|0.9|
91636281|NCT00368069|183164817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.158||||0.034||95.0|0.012|0.305|||ANCOVA|ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.||||0.305|0.012|0.034
91636282|NCT00368069|183164817|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.7||||||95.0|1.2|26.3|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.3|1.2|
91636283|NCT00368069|183164818|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07||95.0|0.95|3.55|||Regression, Logistic|Logistic regression analysis including Treatment as a factor.|Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.|||3.55|0.95|0.070
91636284|NCT00368069|183164819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Mantel Haenszel|Subjects with missing data during the Treatment period were considered in the category \<-25%.||||||0.033
91636285|NCT00368069|183164820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.205||||0.003||95.0|0.07|0.341|||ANCOVA|ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate||||0.341|0.070|0.003
91636286|NCT00368069|183164820|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|18.6||||||95.0|6.7|28.9|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||28.9|6.7|
91636287|NCT00529152|183164900|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Regression, Linear|||Change in Serum Ferritin from baseline to week 24 was compared using regression analysis; null hypothesis was defined as no change in serum ferritin from baseline to week 24||||0.0005
91636288|NCT01497899|183164915|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.|Difference in percentages|-2.9||||0.58|TWO_SIDED|95.0|-13.5|7.7|||Cochran-Mantel-Haenszel|P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.|Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|||7.7|-13.5|0.58
91636289|NCT00082628|183164920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Nonparametric ANCOVA Model|||||||<0.001
91636290|NCT03481634|183164925|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-2.9|0.3||1-sided p-value|ANOVA|||||0.3|-2.9|<0.001
91636291|NCT03481634|183164925|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.94||0.227|TWO_SIDED|95.0|-5.1|-1.4||1-sided p-value|ANOVA|||||-1.4|-5.1|0.227
91636292|NCT03481634|183164926|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-3.0|0.0||(1-sided)|ANOVA|||||-0.0|-3.0|<0.001
91636293|NCT03481634|183164926|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-5.2|-1.7||(1-sided)|ANOVA|||||-1.7|-5.2|
91636294|NCT03481634|183164930|OTHER|Descriptive|LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-6.0|-1.7|||ANOVA|||||-1.7|-6.0|
91636295|NCT03481634|183164930|OTHER|Descriptive|LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.0|0.1|||ANOVA|||||0.1|-4.0|
91636296|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|8.68|||TWO_SIDED|95.0|-17.7|16.4|||ANOVA|||Week 4||16.4|-17.7|
91636297|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|8.41|||TWO_SIDED|95.0|-18.7|14.4|||ANOVA|||Week 4||14.4|-18.7|
91636298|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|12.2|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-5.2|29.7|||ANOVA|||Week 6||29.7|-5.2|
91792694|NCT01293799|183463106|OTHER||Hazard Ratio (HR)|1.35||||0.07|TWO_SIDED|95.0|0.97|1.87||Unit of measure: Ischemic heart disease as comorbidity at baseline (yes vs. no). P \< 0.5 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Ischemic Heart Disease as Comorbidity with time to first peritonitis episode was analysed by univariable Cox regression."||1.87|0.97|0.07
91792695|NCT01293799|183463107|OTHER||Hazard Ratio (HR)|1.06||||0.8|TWO_SIDED|95.0|0.69|1.63||"Unit of measure: Peripheral vascular disease or stroke as comorbidity at PD start (yes vs. no). P-value \<0.05 regarded as statistically significant."|Regression, Cox|Univariable Cox regression||"The association of Peripheral Vascular Disease or Stroke as Comorbidity with time to first peritonitis episode was analysed by univariable Cox regression."||1.63|0.69|0.80
91792696|NCT01293799|183463108|OTHER||Hazard Ratio (HR)|1.15||||0.53|TWO_SIDED|95.0|0.75|1.77||"Unit of measure: Left ventricular dysfunction as comorbidity (yes vs. no). P-value \<0.05 is significant."|Regression, Cox|Univariable Cox regression||"The association of Left ventricular dysfunction as comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found."||1.77|0.75|0.53
91792697|NCT01293799|183463109|OTHER||Hazard Ratio (HR)|1.44||||0.099|TWO_SIDED|95.0|0.93|2.22||"Unit of measure: Diabetes Mellitus as Comorbidity (yes vs. no). P-value \< 0.05 is regarded as statistically significant."|Regression, Cox|Univariable Cox regression||"The association of Diabetes Mellitus as Comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||2.22|0.93|0.099
91792698|NCT01293799|183463110|OTHER||Hazard Ratio (HR)|0.62||||0.22|TWO_SIDED|95.0|0.29|1.32||"Unit of measure: System Collagen Vascular Disease as Comorbidity (yes vs. no). P-value \<0.05 is regarded as statistically significant."|Regression, Cox|Univariable Cox regression||"The association of System Collagen Vascular Disease as Comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.32|0.29|0.22
91792699|NCT01293799|183463111|OTHER||Hazard Ratio (HR)|0.94||||0.79|TWO_SIDED|95.0|0.61|1.46||"Unit of measure: Other Significant Pathology as Comorbidity (yes vs. no). P \< 0.05 is regarded as statistically significant."|Regression, Cox|Univariable Cox regression||"The association of Other Significant Pathology as Comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.46|0.61|0.79
91792700|NCT01293799|183463112|OTHER||Hazard Ratio (HR)|1.06||||0.69|TWO_SIDED|95.0|0.8|1.4||"Unit of measure: Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure (yes vs. no. P-value \< 0.05 is regarded as significantly significant."|Regression, Cox|Univariable Cox regression||"The association of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure with time to first peritonitis episode was analysed by univariable Cox regression."||1.40|0.80|0.69
91792701|NCT01293799|183463113|OTHER||Hazard Ratio (HR)|1.03||||0.86|TWO_SIDED|95.0|0.74|1.42||"Unit of measure: Previous Kidney Replacement Therapy (yes vs. no). P-value \< 0.05 is regarded as significant."|Regression, Cox|Univariable Cox regression||"The association of Previous Kidney Replacement Therapy (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.42|0.74|0.86
91636299|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|8.38|||TWO_SIDED|95.0|-14.0|18.9|||ANOVA|||Week 6||18.9|-14.0|
91636300|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.61|||TWO_SIDED|95.0|-16.0|17.9|||ANOVA|||Week 8||17.9|-16.0|
91636301|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.28|||TWO_SIDED|95.0|-19.6|12.9|||ANOVA|||Week 8||12.9|-19.6|
91636302|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|8.73|||TWO_SIDED|95.0|-10.7|23.6|||ANOVA|||Week 12||23.6|-10.7|
91636303|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|8.85|||TWO_SIDED|95.0|-14.6|20.2|||ANOVA|||Week 12||20.2|-14.6|
91636304|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-15.7|17.8|||ANOVA|||Week 16||17.8|-15.7|
91636305|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.29|||TWO_SIDED|95.0|-19.7|12.9|||ANOVA|||Week 16||12.9|-19.7|
91485176|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.009|TWO_SIDED|95.0|-0.29|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.29|0.009
91485177|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.835|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.835
91636306|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|8.9|STANDARD_ERROR_OF_MEAN|8.92|||TWO_SIDED|95.0|-8.6|26.5|||ANOVA|||Week 18||26.5|-8.6|
91636307|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|95.0|-14.1|19.2|||ANOVA|||Week 18||19.2|-14.1|
91636308|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED|95.0|-20.2|13.4|||ANOVA|||Week 20||13.4|-20.2|
91636309|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-5.8|STANDARD_ERROR_OF_MEAN|8.12|||TWO_SIDED|95.0|-21.7|10.2|||ANOVA|||Week 20||10.2|-21.7|
91636310|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-13.9|STANDARD_ERROR_OF_MEAN|9.06|||TWO_SIDED|95.0|-31.7|3.9|||ANOVA|||Week 24||3.9|-31.7|
91636311|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|8.95|||TWO_SIDED|95.0|-35.4|-0.2|||ANOVA|||Week 24||-0.2|-35.4|
91636312|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.26|||TWO_SIDED|95.0|-25.0|7.5|||ANOVA|||Week 28||7.5|-25.0|
91636313|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.49|||TWO_SIDED|95.0|-25.4|8.0|||ANOVA|||Week 28||8.0|-25.4|
91636314|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|9.49|||TWO_SIDED|95.0|-21.8|15.5|||ANOVA|||Week 32||15.5|-21.8|
91636315|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|95.0|-29.5|6.0|||ANOVA|||Week 32||6.0|-29.5|
91636316|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|36.3|STANDARD_ERROR_OF_MEAN|11.01|||TWO_SIDED|95.0|14.6|57.9|||ANOVA|||Week 36||57.9|14.6|
91636317|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|9.97|||TWO_SIDED|95.0|0.7|40.0|||ANOVA|||Week 36||40.0|0.7|
91636318|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-6.1|STANDARD_ERROR_OF_MEAN|9.19|||TWO_SIDED|95.0|-24.2|11.9|||ANOVA|||Week 40||11.9|-24.2|
91636319|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-6.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-25.2|12.2|||ANOVA|||Week 40||12.2|-25.2|
91636320|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.33|||TWO_SIDED|95.0|-10.4|26.3|||ANOVA|||Week 44||26.3|-10.4|
91636321|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-16.2|18.3|||ANOVA|||Week 44||18.3|-16.2|
91636322|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-5.8|32.9|||ANOVA|||Week 48||32.9|-5.8|
91636323|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|9.26|||TWO_SIDED|95.0|-13.5|23.0|||ANOVA|||Week 48||23.0|-13.5|
91636324|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|9.52|||TWO_SIDED|95.0|-14.5|23.0|||ANOVA|||Week 52||23.0|-14.5|
91636325|NCT03481634|183164933|OTHER|Descriptive|LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-22.3|12.2|||ANOVA|||Week 52||12.2|-22.3|
91636326|NCT03481634|183164934|OTHER|Descriptive|LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-16.6|20.0|||ANOVA|||||20.0|-16.6|
91636327|NCT03481634|183164934|OTHER|Descriptive|LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-20.7|13.8|||ANOVA|||||13.8|-20.7|
91669588|NCT01525628|183233930|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|129.85|STANDARD_DEVIATION|32.5||0.6185|TWO_SIDED|90.0|104.26|161.71|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.71|104.26|0.6185
91669589|NCT01525628|183233931|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|286.01|STANDARD_DEVIATION|39.4||1|TWO_SIDED|90.0|228.51|357.97|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||357.97|228.51|1.0000
91669590|NCT01525628|183233931|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|150.45|STANDARD_DEVIATION|55.1||0.821|TWO_SIDED|90.0|106.81|211.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||211.91|106.81|0.8210
91669591|NCT01525628|183233932|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|349.9|STANDARD_DEVIATION|46.4||1|TWO_SIDED|90.0|269.12|454.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||454.93|269.12|1.0000
91669592|NCT01525628|183233932|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|176.56|STANDARD_DEVIATION|50.1||0.9533|TWO_SIDED|90.0|125.95|247.5|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||247.50|125.95|0.9533
91636328|NCT03481634|183164941|OTHER|Descriptive; Week 28|Difference - %|1.6|||||TWO_SIDED|95.0|-5.3|8.4|||Bootstrap method|||||8.4|-5.3|
91636329|NCT03481634|183164941|OTHER|Descriptive; Week 28|Difference - %|4.1|||||TWO_SIDED|95.0|-2.1|10.3|||Bootstrap method|||||10.3|-2.1|
91636330|NCT03481634|183164941|OTHER|Descriptive; Week 52|Difference - %|5.8|||||TWO_SIDED|95.0|-1.2|12.4|||Bootstrap method|||||12.4|-1.2|
91636331|NCT03481634|183164941|OTHER|Descriptive; Week 52|Difference - %|6.7|||||TWO_SIDED|95.0|0.6|12.9|||Bootstrap method|||||12.9|0.6|
91636332|NCT03481634|183164941|OTHER|Descriptive: Week 76|Difference - %|2.8|||||TWO_SIDED|95.0|-3.9|9.4|||Bootstrap method|||||9.4|-3.9|
91636333|NCT03481634|183164941|OTHER|Descriptive: Week 76|Difference - %|0.7|||||TWO_SIDED|95.0|-5.7|7.0|||Bootstrap method|||||7.0|-5.7|
91636334|NCT03481634|183164941|OTHER|Descriptive: Week 100|Difference - %|1.7|||||TWO_SIDED|95.0|-5.0|8.1|||Bootstrap method|||||8.1|-5.0|
91636335|NCT03481634|183164941|OTHER|Descriptive: Week 100|Difference - %|2.2|||||TWO_SIDED|95.0|-4.0|8.4|||Bootstrap method|||||8.4|-4.0|
91636336|NCT03481634|183164943|OTHER|Descriptive; Week 28|Difference - %|-0.3|||||TWO_SIDED|95.0|-6.4|5.8|||Bootstrap method|||||5.8|-6.4|
91636337|NCT03481634|183164943|OTHER|Descriptive; Week 28|Difference - %|4.6|||||TWO_SIDED|95.0|-1.3|11.0|||Bootstrap method|||||11.0|-1.3|
91636338|NCT03481634|183164943|OTHER|Descriptive; Week 52|Difference - %|-4.2|||||TWO_SIDED|95.0|-10.2|2.2|||Bootstrap method|||||2.2|-10.2|
91636339|NCT03481634|183164943|OTHER|Descriptive; Week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.2|10.5|||Bootstrap method|||||10.5|-2.2|
91636340|NCT03481634|183164943|OTHER|Descriptive; Week 72|Difference - %|-9.2|||||TWO_SIDED|95.0|-15.5|-2.8|||Bootstrap method|||||-2.8|-15.5|
91714948|NCT00248651|183321130|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of \<0.05 was considered statistically significant.||||0.01
91714949|NCT00248651|183321130|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of \<0.05 was considered statistically significant.||||0.04
91669593|NCT01525628|183233933|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|322.68|STANDARD_DEVIATION|40.4||1|TWO_SIDED|90.0|256.24|406.34|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||406.34|256.24|1.0000
91669594|NCT01525628|183233933|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|145.93|STANDARD_DEVIATION|66.2||0.7461|TWO_SIDED|90.0|97.83|217.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||217.69|97.83|0.7461
91669595|NCT01525628|183233934|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|355.04|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|298.13|422.83|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||422.83|298.13|1.0000
91669596|NCT01525628|183233934|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|120.67|STANDARD_DEVIATION|58.3||0.4337|TWO_SIDED|90.0|83.68|174.01|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||174.01|83.68|0.4337
91669597|NCT01525628|183233935|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|397.73|STANDARD_DEVIATION|31.6||1|TWO_SIDED|90.0|330.79|478.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||478.22|330.79|1.0000
91669598|NCT01525628|183233935|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|142.27|STANDARD_DEVIATION|53.1||0.7346|TWO_SIDED|90.0|99.49|203.44|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||203.44|99.49|0.7346
91669599|NCT01525628|183233936|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|403.86|STANDARD_DEVIATION|33.6||1|TWO_SIDED|90.0|332.19|490.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||490.99|332.19|1.0000
91669600|NCT01525628|183233936|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|116.96|STANDARD_DEVIATION|73.1||0.3968|TWO_SIDED|90.0|75.38|181.47|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||181.47|75.38|0.3968
91669601|NCT01525628|183233937|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|408.66|STANDARD_DEVIATION|45.9||1|TWO_SIDED|90.0|315.15|529.9|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||529.90|315.15|1.0000
91669602|NCT01525628|183233937|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|301.19|STANDARD_DEVIATION|62.1||0.9993|TWO_SIDED|90.0|204.61|443.35|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||443.35|204.61|0.9993
91669603|NCT01525628|183233938|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|450.51|STANDARD_DEVIATION|48.0||1|TWO_SIDED|90.0|343.67|590.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||590.57|343.67|1.0000
91669604|NCT01525628|183233938|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|341.96|STANDARD_DEVIATION|61.1||0.9996|TWO_SIDED|90.0|229.22|510.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||510.13|229.22|0.9996
91636341|NCT03481634|183164943|OTHER|Descriptive; Week 72|Difference - %|-2.3|||||TWO_SIDED|95.0|-8.4|4.4|||Bootstrap method|||||4.4|-8.4|
91636342|NCT03481634|183164943|OTHER|Descriptive; Week 100|Difference - %|-7.7|||||TWO_SIDED|95.0|-14.0|-1.6|||Bootstrap method|||||-1.6|-14.0|
91636343|NCT03481634|183164943|OTHER|Descriptive; Week 100|Difference - %|0.4|||||TWO_SIDED|95.0|-5.7|6.8|||Bootstrap method|||||6.8|-5.7|
91636344|NCT03099304|183164965|SUPERIORITY||Odds Ratio (OR)|13.79||||0.0057|TWO_SIDED|95.0|1.73|640.85||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||640.85|1.73|0.0057
91636345|NCT03099304|183164965|SUPERIORITY||Odds Ratio (OR)|10.3||||0.0243|TWO_SIDED|95.0|1.24|487.28||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||487.28|1.24|0.0243
91636346|NCT03099304|183164965|SUPERIORITY||Odds Ratio (OR)|28.48|||<|0.0001|TWO_SIDED|95.0|3.74|1305.2||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1305.2|3.74|<0.0001
91636347|NCT03099304|183164965|SUPERIORITY||Odds Ratio (OR)|24.66||||0.0001|TWO_SIDED|95.0|3.28|1121.4||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1121.4|3.28|0.0001
91636348|NCT03099304|183164966|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.05|0.4936
91636349|NCT03099304|183164966|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.62|0.1140
91636350|NCT03099304|183164966|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||1.00|0.0501
91636351|NCT03099304|183164966|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.58|0.1257
91636352|NCT03099304|183164967|SUPERIORITY||Odds Ratio (OR)|1.19||||0.9794|TWO_SIDED|95.0|0.33|4.33|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||4.33|0.33|0.9794
91636353|NCT03099304|183164967|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4893|TWO_SIDED|95.0|0.51|5.86|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||5.86|0.51|0.4893
91636354|NCT03099304|183164974|SUPERIORITY||Least squares mean (LSM) difference|-0.44|STANDARD_ERROR_OF_MEAN|0.16||0.0056|TWO_SIDED|95.0|-0.75|-0.13|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.13|-0.75|0.0056
91636355|NCT03099304|183164974|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0095|TWO_SIDED|95.0|-0.7|-0.1|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.10|-0.70|0.0095
91636356|NCT03099304|183164974|SUPERIORITY||LSM difference|-0.68|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.37|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.37|-0.99|<0.0001
91636357|NCT03099304|183164974|SUPERIORITY||LSM difference|-0.51|STANDARD_ERROR_OF_MEAN|0.15||0.0011|TWO_SIDED|95.0|-0.8|-0.21|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.21|-0.80|0.0011
91636358|NCT03099304|183164976|SUPERIORITY||LSM difference|-36.71|STANDARD_ERROR_OF_MEAN|10.34||0.0005|TWO_SIDED|95.0|-57.15|-16.27|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.27|-57.15|0.0005
91636359|NCT03099304|183164976|SUPERIORITY||LM difference|-35.12|STANDARD_ERROR_OF_MEAN|10.01||0.0006|TWO_SIDED|95.0|-54.91|-15.33|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-15.33|-54.91|0.0006
91636360|NCT03099304|183164976|SUPERIORITY||LSM difference|-46.02|STANDARD_ERROR_OF_MEAN|10.35|<|0.0001|TWO_SIDED|95.0|-66.47|-25.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-25.57|-66.47|<0.0001
91636361|NCT03099304|183164976|SUPERIORITY||LSM difference|-43.8|STANDARD_ERROR_OF_MEAN|9.98|<|0.0001|TWO_SIDED|95.0|-63.52|-24.07|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-24.07|-63.52|<0.0001
91636362|NCT03099304|183164983|SUPERIORITY||LSM difference|-2.84|STANDARD_ERROR_OF_MEAN|1.32||0.0326|TWO_SIDED|95.0|-5.44|-0.24|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.24|-5.44|0.0326
91636363|NCT03099304|183164983|SUPERIORITY||LSM difference|-2.74|STANDARD_ERROR_OF_MEAN|1.28||0.0333|TWO_SIDED|95.0|-5.26|-0.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.22|-5.26|0.0333
91636364|NCT03099304|183164983|SUPERIORITY||LSM difference|-5.08|STANDARD_ERROR_OF_MEAN|1.31||0.0002|TWO_SIDED|95.0|-7.68|-2.48|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-2.48|-7.68|0.0002
91636365|NCT03099304|183164983|SUPERIORITY||LSM difference|-4.08|STANDARD_ERROR_OF_MEAN|1.27||0.0016|TWO_SIDED|95.0|-6.59|-1.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-1.57|-6.59|0.0016
91669605|NCT01525628|183233939|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|466.92|STANDARD_DEVIATION|47.6||1|TWO_SIDED|90.0|357.02|610.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||610.66|357.02|1.0000
91669606|NCT01525628|183233939|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|298.57|STANDARD_DEVIATION|79.2||0.9972|TWO_SIDED|90.0|187.22|476.15|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||476.15|187.22|0.9972
91669607|NCT01525628|183233940|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|528.95|STANDARD_DEVIATION|42.0||1|TWO_SIDED|90.0|415.88|672.75|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||672.75|415.88|1.0000
91669608|NCT01525628|183233940|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|384.0|STANDARD_DEVIATION|69.2||0.9998|TWO_SIDED|90.0|251.56|586.16|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||586.16|251.56|0.9998
91636366|NCT03099304|183164985|SUPERIORITY||LSM difference|-23.53|STANDARD_ERROR_OF_MEAN|6.99||0.001|TWO_SIDED|95.0|-37.35|-9.71|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-9.71|-37.35|0.0010
91636367|NCT03099304|183164985|SUPERIORITY||LSM difference|-18.47|STANDARD_ERROR_OF_MEAN|6.77||0.0072|TWO_SIDED|95.0|-31.86|-5.08|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-5.08|-31.86|0.0072
91636368|NCT03099304|183164985|SUPERIORITY||LSM difference|-29.81|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|95.0|-43.61|-16.0|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.00|-43.61|<0.0001
91636369|NCT03099304|183164985|SUPERIORITY||LSM difference|-25.56|STANDARD_ERROR_OF_MEAN|6.75||0.0002|TWO_SIDED|95.0|-38.89|-12.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-12.22|-38.89|0.0002
91636370|NCT03099304|183164997|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.05|0.4936
91636371|NCT03099304|183164997|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.62|0.1140
91636372|NCT03099304|183164997|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||1.00|0.0501
91636373|NCT03099304|183164997|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.58|0.1257
91636374|NCT01624974|183165014|SUPERIORITY||Difference in Least Squares (LS) Means|0.047||||0.282|TWO_SIDED|95.0|-0.039|0.134|||LDA model|The LDA model assumes that repeated measurements follow a multivariate normal distribution.||||0.134|-0.039|0.282
91636375|NCT02828982|183165043|SUPERIORITY|||||||0.585||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there would be no difference in metabolic costs between the two groups||||0.585
91636376|NCT02828982|183165044|SUPERIORITY|||||||0.452||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there were no differences in the number of steps taken outside of the home for the two prostheses.||||0.452
91636377|NCT02828982|183165045|OTHER|paired t-test of Physical component scores between the two conditions||||||0.48||||||a prior threshold for significance was 0.05|t-test, 2 sided|||||||0.480
91636378|NCT02828982|183165045|SUPERIORITY|||||||0.408||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||Mental Component Score||||0.408
91636379|NCT02828982|183165046|SUPERIORITY|||||||0.058||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Ambulation Score||||0.058
91636380|NCT02828982|183165046|OTHER|paired t-test between conditions||||||0.123||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Appearance Score||||.123
91636381|NCT02828982|183165046|OTHER|paired t-test between conditions||||||0.052||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Frustration Score||||.052
91636382|NCT02828982|183165046|OTHER|paired t-test between conditions||||||0.188||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Perceived Response Score||||.188
91636383|NCT02828982|183165046|OTHER|paired t-test between conditions||||||0.336||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Limb Health Score||||.336
91669609|NCT01525628|183233941|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|569.81|STANDARD_DEVIATION|42.2||1|TWO_SIDED|90.0|447.49|725.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||725.57|447.49|1.0000
91669610|NCT01525628|183233941|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|441.89|STANDARD_DEVIATION|66.9||0.9999|TWO_SIDED|90.0|286.81|680.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||680.82|286.81|0.9999
91669611|NCT01525628|183233942|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|606.29|STANDARD_DEVIATION|44.2||1|TWO_SIDED|90.0|471.42|779.74|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||779.74|471.42|1.0000
91669612|NCT01525628|183233942|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|377.98|STANDARD_DEVIATION|82.0||0.9994|TWO_SIDED|90.0|233.48|611.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||611.91|233.48|0.9994
91669613|NCT01525628|183233943|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|97.03|STANDARD_DEVIATION|30.8||0.05|TWO_SIDED|90.0|80.0|117.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||117.69|80.00|0.0500
91669614|NCT01525628|183233943|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|97.1|STANDARD_DEVIATION|31.2||0.0564|TWO_SIDED|90.0|79.37|118.79|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||118.79|79.37|0.0564
91669615|NCT01525628|183233943|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|114.38|STANDARD_DEVIATION|31.9||0.2375|TWO_SIDED|90.0|92.36|141.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.66|92.36|0.2375
91669616|NCT01525628|183233943|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|139.07|STANDARD_DEVIATION|22.8||0.9082|TWO_SIDED|90.0|121.63|159.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||159.00|121.63|0.9082
91669617|NCT01525628|183233943|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|122.37|STANDARD_DEVIATION|29.3||0.4111|TWO_SIDED|90.0|104.11|143.84|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||143.84|104.11|0.4111
91669618|NCT01525628|183233943|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|121.43|STANDARD_DEVIATION|24.7||0.3719|TWO_SIDED|90.0|104.24|141.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.45|104.24|0.3719
91714950|NCT05607576|183321137|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values blood glucose readings (mg/dL) were grouped based on radiation exposure (\>0-500 µGy and \>500 µGy). A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects were used to assess absolute differences in BG mg/dL by cumulative scatter||||||<0.05
91669619|NCT01525628|183233944|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|88.37|STANDARD_DEVIATION|20.8||0.1037|TWO_SIDED|90.0|77.39|100.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||100.89|77.39|0.1037
91714951|NCT05607576|183321138|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values. A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects over time were used to assess absolute differences in BG mg/dL by time||||||<0.05
91714952|NCT00870467|183321139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91669620|NCT01525628|183233944|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|159.11|STANDARD_DEVIATION|57.8||0.8723|TWO_SIDED|90.0|111.06|227.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||227.93|111.06|0.8723
91669621|NCT01525628|183233944|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|259.57|STANDARD_DEVIATION|92.5||0.983|TWO_SIDED|90.0|150.65|447.21|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||447.21|150.65|0.9830
91669622|NCT01525628|183233944|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|163.95|STANDARD_DEVIATION|38.1||0.9689|TWO_SIDED|90.0|129.52|207.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||207.52|129.52|0.9689
91792702|NCT01293799|183463114|OTHER||Hazard Ratio (HR)|1.0||||0.6|TWO_SIDED|95.0|0.98|1.01||Unit of measure: Functional status (Karnofsky score). Functional status was estimated by the Karnofsky Performance Scale. Scores from 100 (Normal, no complaints) to 0 = (dead). 90 = Able to carry on normal activity. 80 = Normal activity with effort.|Regression, Cox|Univariable Cox regression||"The association of Functional status (Karnofsky score) with time to first peritonitis episode was analysed by univariable Cox regression."||1.01|0.98|0.60
91485178|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.463|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.463
91527845|NCT06173570|182930691|SUPERIORITY||Mean Difference (Net)|-21.54|||<|0.001|TWO_SIDED|95.0|-26.73|-16.35|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-16.35|-26.73|< 0.001
91669623|NCT01525628|183233944|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|219.88|STANDARD_DEVIATION|70.4||0.9933|TWO_SIDED|90.0|153.84|314.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||314.26|153.84|0.9933
91669624|NCT01525628|183233944|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|214.4|STANDARD_DEVIATION|66.8||0.9865|TWO_SIDED|90.0|145.88|315.09|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||315.09|145.88|0.9865
91669625|NCT01525628|183233945|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|96.06|STANDARD_DEVIATION|14.2||0.0015|TWO_SIDED|90.0|87.77|105.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||105.13|87.77|0.0015
91669626|NCT01525628|183233945|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|85.41|STANDARD_DEVIATION|17.2||0.1617|TWO_SIDED|90.0|76.32|95.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||95.57|76.32|0.1617
91669627|NCT01525628|183233945|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|73.26|STANDARD_DEVIATION|17.5||0.893|TWO_SIDED|90.0|65.03|82.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||82.54|65.03|0.8930
91669628|NCT01525628|183233945|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|92.23|STANDARD_DEVIATION|10.5||0.0005|TWO_SIDED|90.0|86.67|98.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||98.13|86.67|0.0005
91485179|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.713|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.16|0.713
91485180|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.267|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.267
91714953|NCT00870467|183321140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91714954|NCT00870467|183321141|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91636384|NCT02828982|183165046|OTHER|paired t-test between conditions||||||0.043||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Social Burden Score||||.043
91636385|NCT02828982|183165046|OTHER|paired t-test between conditions||||||0.391||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Sounds Score||||.391
91636386|NCT02828982|183165046|SUPERIORITY|paired t-test between conditions||||||0.799||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Utility Score||||.799
91636387|NCT02828982|183165046|SUPERIORITY|||||||0.173||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Well-Being||||.173
91669629|NCT01525628|183233945|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|73.93|STANDARD_DEVIATION|21.6||0.8646|TWO_SIDED|90.0|65.55|83.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||83.39|65.55|0.8646
91669630|NCT01525628|183233945|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|75.42|STANDARD_DEVIATION|16.4||0.8378|TWO_SIDED|90.0|68.15|83.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.45|68.15|0.8378
91669631|NCT01525628|183233946|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|98.17|STANDARD_DEVIATION|12.3||0.0005|TWO_SIDED|90.0|90.15|106.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||106.91|90.15|0.0005
91669632|NCT01525628|183233946|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|81.26|STANDARD_DEVIATION|11.7||0.3638|TWO_SIDED|90.0|75.19|87.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||87.82|75.19|0.3638
91669633|NCT01525628|183233946|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.93|STANDARD_DEVIATION|22.6||0.8975|TWO_SIDED|90.0|60.44|83.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.22|60.44|0.8975
91636388|NCT02828982|183165047|OTHER|paired t-test between conditions||||||0.655||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Biceps Femoris||||0.655
91636389|NCT02828982|183165047|OTHER|paired t-test between conditions||||||0.281||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Rectus Femoris||||.281
91636390|NCT02828982|183165047|OTHER|paired t-test between conditions||||||0.844||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Soleus||||.844
91636391|NCT02828982|183165047|OTHER|paired t-test between conditions||||||0.11||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Tibialis Anterior||||.110
91636392|NCT02828982|183165047|OTHER|paired t-test between conditions||||||0.394||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Biceps Femoris||||.394
91636393|NCT02828982|183165047|SUPERIORITY|||||||0.141||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Rectus Femoris||||.141
91636394|NCT02828982|183165048|SUPERIORITY|||||||0.212||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||||||0.212
91636395|NCT02475564|183165049|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mann-Whitney test|||A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.||||0.7
91636396|NCT02475564|183165050|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mann-Whitney test|||||||0.1
91636397|NCT02475564|183165051|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mann-Whitney test|||||||0.8
91636398|NCT02705755|183165062|SUPERIORITY||Least Squares Mean Difference|-4.4||||0.0399|TWO_SIDED|95.0|-8.57|-0.23||P-values were reported without multiplicity adjustment.|Repeated-measures Mixed-effect Model|||Least squares mean differences were calculated based on a repeated-measures mixed-effect model with change from baseline at different time points as the dependent variable, the treatment group (TD-9855 or placebo), time point, baseline and the interaction between the treatment group and time point as fixed factors. A compound symmetry was used as the variance-covariance structure.||-0.23|-8.57|0.0399
91636399|NCT01906489|183165070|SUPERIORITY||Odds Ratio (OR)|11.4739|||=|0.0001|TWO_SIDED|95.0|3.3505|39.2931|||Fisher Exact|||||39.2931|3.3505|=0.0001
91636400|NCT01906489|183165071|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91636401|NCT01906489|183165072|OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91636402|NCT01906489|183165074|OTHER||||||=|0.0953|TWO_SIDED||||||Fisher Exact|||||||=0.0953
91636403|NCT01906489|183165075|OTHER||||||=|0.1238|TWO_SIDED||||||Fisher Exact|||||||=0.1238
91636404|NCT01906489|183165076|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91636405|NCT01906489|183165077|OTHER||||||=|0.0019|||||||t-test, 2 sided|||Week 2||||=0.0019
91636406|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
91636407|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
91636408|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
91636409|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
91714955|NCT00870467|183321142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91714956|NCT00870467|183321143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91485181|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.552|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.552
91525971|NCT03502616|182927257|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.47||0.4092|TWO_SIDED|95.0|-0.54|1.31|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.31|-0.54|0.4092
91485182|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.885|TWO_SIDED|95.0|-0.12|0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.12|0.885
91636410|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
91636411|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
91636412|NCT01906489|183165077|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
91636413|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
91636414|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
91636415|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
91636416|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
91636417|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
91636418|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
91636419|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
91636420|NCT01906489|183165079|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
91636421|NCT01906489|183165081|OTHER||||||=|0.0031|||||||t-test, 2 sided|||Week 2||||=0.0031
91636422|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
91636423|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
91636424|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
91636425|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
91636426|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
91636427|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
91636428|NCT01906489|183165081|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
91636429|NCT01906489|183165083|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
91636430|NCT01906489|183165083|OTHER||||||=|0.0133|||||||t-test, 2 sided|||Week 4||||=0.0133
91636431|NCT01906489|183165083|OTHER||||||=|0.3053|||||||t-test, 2 sided|||Week 6||||=0.3053
91636432|NCT01906489|183165083|OTHER||||||=|0.1918|||||||t-test, 2 sided|||Week 8||||=0.1918
91636433|NCT01906489|183165083|OTHER||||||=|0.209|||||||t-test, 2 sided|||Week 12||||=0.2090
91636434|NCT01906489|183165083|OTHER||||||=|0.6184|||||||t-test, 2 sided|||Week 16||||=0.6184
91636435|NCT01906489|183165083|OTHER||||||=|0.3604|||||||t-test, 2 sided|||Week 19||||=0.3604
91636436|NCT01906489|183165083|OTHER||||||=|0.4056|||||||t-test, 2 sided|||Week 20||||=0.4056
91636437|NCT01906489|183165089|OTHER||Hazard Ratio (HR)|4.1451|||=|0.0017|TWO_SIDED|95.0|1.5752|10.908|||Log Rank|||||10.9080|1.5752|=0.0017
91636438|NCT01707667|183165124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.012|TWO_SIDED|95.0|1.6|9.9|||Linear Mixed-Effect Models Analysis|||||9.9|1.6|0.012
91636439|NCT01707667|183165125|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|69051.4||||0.079|TWO_SIDED|95.0|-12004.5|150107.3|||Linear Mixed-Effect Models Analysis|||||150107.3|-12004.5|0.079
91636440|NCT01707667|183165126|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2||||0.717|TWO_SIDED|95.0|-45.3|63.7|||Linear Mixed-Effect Models Analysis|||||63.7|-45.3|0.717
91636441|NCT01707667|183165127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED||||||Log Rank|||||||0.295
91636442|NCT01707667|183165128|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.18|TWO_SIDED|95.0|-0.465|0.107|||Linear Mixed-Effect Models Analysis|||||0.107|-0.465|0.180
91636443|NCT01707667|183165129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.8||||0.225|TWO_SIDED|95.0|-12.6|44.3|||Linear Mixed-Effect Models Analysis|||||44.3|-12.6|0.225
91636444|NCT03802331|183165131|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|166.02|||||TWO_SIDED|90.0|143.17|192.53|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 19.0.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||192.53|143.17|
91636445|NCT03802331|183165132|OTHER|Relative bioavailability|Ajusted Geometric Mean Ratio T/R (%)|235.5|||||TWO_SIDED|90.0|179.82|308.42|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 35.4.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||308.42|179.82|
91636446|NCT03802331|183165133|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|159.39|||||TWO_SIDED|90.0|140.11|181.34|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 16.5.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||181.34|140.11|
91636447|NCT03432819|183165142|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|9.24||||0.06|TWO_SIDED|95.0|-0.55|19.03|||Regression, Linear|||||19.03|-0.55|0.06
91636448|NCT03432819|183165143|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|4.5||||0.02|TWO_SIDED|95.0|0.7|8.3|||Regression, Linear|||||8.30|0.70|0.02
91636449|NCT03432819|183165144|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|0.08||||0.39|TWO_SIDED|95.0|-0.1|0.26|||Regression, Linear|||||0.26|-0.10|0.39
91636450|NCT03432819|183165145|SUPERIORITY||Median Difference (Final Values)|-0.09||||0.54|TWO_SIDED|95.0|-0.37|0.2|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.20|-0.37|0.54
91636451|NCT03432819|183165146|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.81|TWO_SIDED|95.0|-0.18|0.14|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.14|-0.18|0.81
91636452|NCT03432819|183165147|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.06|TWO_SIDED|95.0|-0.37|0.01|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.01|-0.37|0.06
91636453|NCT03432819|183165148|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.16|TWO_SIDED|95.0|-0.78|0.13|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.13|-0.78|0.16
91636454|NCT03432819|183165149|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.02|TWO_SIDED|95.0|-0.84|-0.09|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||-0.09|-0.84|0.02
91636455|NCT03432819|183165150|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.71|TWO_SIDED|95.0|-0.32|0.47|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.47|-0.32|0.71
91636456|NCT03432819|183165151|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.1|TWO_SIDED|95.0|-0.73|0.06|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.06|-0.73|0.10
91636457|NCT02735382|183165167|SUPERIORITY||Odds Ratio (OR)|4.663|||<|0.0001|TWO_SIDED|95.0|4.116|5.283|||Chi-squared, Corrected|||||5.283|4.116|<.0001
91636458|NCT02735382|183165168|SUPERIORITY||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.672|4.035|||Chi-squared, Corrected|||||4.035|2.672|<.0001
91636459|NCT02735382|183165169|SUPERIORITY||Odds Ratio (OR)|0.885||||0.8438|TWO_SIDED|95.0|0.42|1.698|||Chi-squared, Corrected|||||1.698|0.420|.8438
91636460|NCT02735382|183165170|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.161||0.007|TWO_SIDED|95.0|0.123|0.757|||t-test, 2 sided|df=292||A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.||0.757|0.123|.007
91669634|NCT01525628|183233946|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|86.37|STANDARD_DEVIATION|18.1||0.1144|TWO_SIDED|90.0|77.62|96.11|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||96.11|77.62|0.1144
91636461|NCT02996981|183165185|SUPERIORITY|||||||0.299|||||||Chi-squared|df=1||||||0.299
91636462|NCT03451630|183165222|SUPERIORITY|||||||0.0211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (6, 3152).||Overall Test of Group by Time Interaction||||0.0211
91714957|NCT00870467|183321144|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91669635|NCT01525628|183233946|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|64.66|STANDARD_DEVIATION|11.8||1|TWO_SIDED|90.0|60.42|69.2|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||69.20|60.42|1.0000
91669636|NCT01525628|183233946|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|63.75|STANDARD_DEVIATION|17.3||0.9988|TWO_SIDED|90.0|57.19|71.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||71.07|57.19|0.9988
91669637|NCT01525628|183233947|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|144.78|STANDARD_DEVIATION|19.0||0.9749|TWO_SIDED|90.0|128.3|163.36|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||163.36|128.30|0.9749
91669638|NCT01525628|183233947|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|152.94|STANDARD_DEVIATION|26.8||0.9703|TWO_SIDED|90.0|128.6|181.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||181.89|128.60|0.9703
91669639|NCT01525628|183233947|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|102.99|STANDARD_DEVIATION|29.3||0.05|TWO_SIDED|90.0|84.85|124.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||124.99|84.85|0.0500
91669640|NCT01525628|183233947|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|124.22|STANDARD_DEVIATION|24.1||0.4697|TWO_SIDED|90.0|107.91|142.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||142.99|107.91|0.4697
91669641|NCT01525628|183233947|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|120.74|STANDARD_DEVIATION|19.2||0.2906|TWO_SIDED|90.0|108.47|134.38|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||134.38|108.47|0.2906
91669642|NCT01525628|183233947|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|93.95|STANDARD_DEVIATION|25.2||0.046|TWO_SIDED|90.0|80.33|109.86|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.86|80.33|0.0460
91669643|NCT01525628|183233948|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|151.66|STANDARD_DEVIATION|18.5||0.9941|TWO_SIDED|90.0|134.79|170.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||170.64|134.79|0.9941
91669644|NCT01525628|183233948|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|163.42|STANDARD_DEVIATION|26.0||0.9926|TWO_SIDED|90.0|137.91|193.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||193.64|137.91|0.9926
91669645|NCT01525628|183233948|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|98.14|STANDARD_DEVIATION|28.1||0.0392|TWO_SIDED|90.0|81.2|118.63|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||118.63|81.20|0.0392
91669646|NCT01525628|183233948|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|122.58|STANDARD_DEVIATION|37.2||0.4374|TWO_SIDED|90.0|99.15|151.55|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||151.55|99.15|0.4374
91669647|NCT01525628|183233948|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|130.44|STANDARD_DEVIATION|35.3||0.647|TWO_SIDED|90.0|107.57|158.18|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||158.18|107.57|0.6470
91669648|NCT01525628|183233948|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|87.77|STANDARD_DEVIATION|36.9||0.2372|TWO_SIDED|90.0|70.32|109.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.54|70.32|0.2372
91714958|NCT03430856|183321185|NON_INFERIORITY|Change from baseline in HbA1c at 24 weeks of treatment, was analyzed using mixed model for repeated measures (MMRM) where all available post-baseline HbA1c measurements obtained up to Week 24 was entered as the dependent variables; visit and treatment were included as fixed factors, with Baseline HbA1c and stratification factor variables as covariates. Furthermore, the interaction terms of visit by treatment, visit by stratification factors and visit by Baseline HbA1c were included in the model.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.502|1.47|||||Insulin Tregopil 45 mg - Insulin Aspart|||1.470|0.502|
91714959|NCT03430856|183321185|NON_INFERIORITY|Non inferiority margin is 0.4%|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.414|1.37|||||Insulin Tregopil 30mg - Insulin Aspart|||1.370|0.414|
91714960|NCT02357459|183321198|SUPERIORITY|The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.47|-0.49||The threshold for significance was \<0.05.|longitudinal mixed repeated measures|||||-0.49|-1.47|<0.0001
91669649|NCT01525628|183233949|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|117.67|STANDARD_DEVIATION|15.6||0.1519|TWO_SIDED|90.0|106.49|130.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||130.00|106.49|0.1519
91714961|NCT03246347|183321212|SUPERIORITY||Proportion|0.6111|||<|0.001|TWO_SIDED|95.0|0.4346|0.7686|||One-sided test for binomial proportions|||The 12-month PSA CR rate with ADT + docetaxel is 27.7% (Sweeney 2015); we estimated that the lower limit of the 95% CI was 23.4%. We sought to test the null hypothesis that the 52-week PSA CR rate for subjects treated with study therapy was \<=25%. We anticipated enrolling 39 subjects and this design would provide 90% power with a 1-sided alpha =0.10 significance level, assuming the true 52-week PSA CR rate was 45%. An improvement from 25% to 45% in 52-week PSA CR rate was considered important.||.7686|.4346|<0.001
91714962|NCT01228591|183321229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05logMAR.|Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0044|0.0187|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0187|-0.0044|
91714963|NCT01228591|183321229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0086|0.0146|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0146|-0.0086|
91714964|NCT01228591|183321230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|0.0041|0.0282|||Mixed Models Analysis||Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).|"For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.0282|0.0041|
91714965|NCT01228591|183321230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.009|0.3305|||Mixed Models Analysis||Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).|"For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.3305|0.0090|
91525972|NCT03502616|182927257|SUPERIORITY||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.506||0.107|TWO_SIDED|95.0|-0.18|1.81|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.81|-0.18|0.1070
91525973|NCT03502616|182927258|SUPERIORITY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|0.428||0.0002|TWO_SIDED|95.0|0.78|2.46|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.46|0.78|0.0002
91669650|NCT01525628|183233949|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|117.01|STANDARD_DEVIATION|30.9||0.2827|TWO_SIDED|90.0|96.06|142.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day17 vs. Day 1||142.52|96.06|0.2827
91669651|NCT01525628|183233949|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|92.11|STANDARD_DEVIATION|32.6||0.1326|TWO_SIDED|90.0|74.38|114.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||114.07|74.38|0.1326
91669652|NCT01525628|183233949|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|95.55|STANDARD_DEVIATION|29.2||0.0432|TWO_SIDED|90.0|80.63|113.24|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||113.24|80.63|0.0432
91669653|NCT01525628|183233949|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|75.19|STANDARD_DEVIATION|30.3||0.7367|TWO_SIDED|90.0|63.64|88.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||88.82|63.64|0.7367
91722497|NCT00311168|183337788|SUPERIORITY|A target of an 80% reduction in percentage of ventricular pacing with VIP™ is proposed in this study. In order to achieve an 80% power of detecting an 80% reduction in the percentage of ventricular paced events and using a two group two-sided t-test of equal means, a minimum sample size of 39 patients per group was required. To account for possible withdrawal or loss to follow-up, this study targeted to enroll 100 patients (50 per group).|Mean Difference (Final Values)|-60.2|STANDARD_DEVIATION|19.0|<|0.0001|TWO_SIDED|95.0|-67.5|-52.9|||t-test, 2 sided||Mean difference in the percentage of intrinsic ventricular events is presented as, VIP Off - VIP On.|||-52.9|-67.5|<0.0001
91636463|NCT03451630|183165222|SUPERIORITY||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.22||0.028|TWO_SIDED|95.0|0.29|5.09||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 4.83 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||5.09|0.29|0.0280
91636464|NCT03451630|183165222|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|1.23||0.0935|TWO_SIDED|95.0|-0.35|4.48||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.81 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||4.48|-0.35|0.0935
91636465|NCT03451630|183165222|SUPERIORITY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|1.05||0.5538|TWO_SIDED|95.0|-1.44|2.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.35 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to12-Months using linear contrast.||2.68|-1.44|0.5538
91636466|NCT03451630|183165223|SUPERIORITY|Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).||||||0.8505|||||||Mixed Models Analysis|F-statistics 0.44 with degrees of freedom (6, 3154).||Overall Test of the Group by Time Interaction||||0.8505
91636467|NCT03451630|183165223|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 16.97 with degrees of freedom (3, 3160).||Test for significant change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
91669654|NCT01525628|183233949|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.14|STANDARD_DEVIATION|34.3||0.8547|TWO_SIDED|90.0|56.84|86.56|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||86.56|56.84|0.8547
91669655|NCT01525628|183233950|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|102.7|STANDARD_DEVIATION|45.9||0.1159|TWO_SIDED|90.0|77.89|135.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||135.39|77.89|0.1159
91669656|NCT01525628|183233950|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|99.99|STANDARD_DEVIATION|38.7||0.0651|TWO_SIDED|90.0|78.33|127.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||127.64|78.33|0.0651
91714966|NCT02371616|183321255|NON_INFERIORITY|Inferences: upper end of the 2-sided 95% CI for the treatment difference for the estimated effect of Test relative to Comparator, for success, should be \<=6mm. (i.e., Test is no more than 6mm inferior to Comparator).|Least square (LS) mean difference|2.67||||0.2678|TWO_SIDED|95.0|-2.06|7.4||From ANCOVA model: change from baseline as the response variable, treatment group, baseline Schiff stratum and study site as fixed effects, with baseline VAS score as covariate.|ANCOVA||Difference is first named treatment minus second named dentifrice such that a negative difference favors the first named treatment.|Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.||7.40|-2.06|0.2678
91714967|NCT01921517|183321263|SUPERIORITY|||||||0.0481|||||||t-test, 2 sided|||||||0.0481
91714968|NCT03205150|183321264|SUPERIORITY||Mean Difference (Net)|-13.29|STANDARD_ERROR_OF_MEAN|7.35||0.075|TWO_SIDED|80.0|-22.8|-3.78|||ANCOVA|||||-3.78|-22.80|0.075
91714969|NCT03205150|183321264|SUPERIORITY||Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|7.49||0.005|TWO_SIDED|80.0|-31.33|-11.94|||ANCOVA|||||-11.94|-31.33|0.005
91714970|NCT03205150|183321264|SUPERIORITY||Mean Difference (Net)|8.35|STANDARD_ERROR_OF_MEAN|6.14||0.178|TWO_SIDED|80.0|0.41|16.29|||ANCOVA|||||16.29|0.41|0.178
91525974|NCT03502616|182927258|SUPERIORITY||LS mean difference|1.92|STANDARD_ERROR_OF_MEAN|0.466|<|0.0001|TWO_SIDED|95.0|1.0|2.84|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.00|<0.0001
91636468|NCT03451630|183165223|SUPERIORITY|||||||0.8656||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.14 with degrees of freedom (2, 1229).||Test for significant change by treatment when the treatment-by-time interaction effect is not significant.||||0.8656
91636469|NCT03451630|183165223|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.29||0.474|TWO_SIDED|95.0|-1.61|3.46||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.51 with degrees of freedom (1, 3154)||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.46|-1.61|0.4740
91636470|NCT03451630|183165223|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.26||0.6017|TWO_SIDED|95.0|-1.81|3.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.27 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.13|-1.81|0.6017
91636471|NCT03451630|183165223|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.99||0.786|TWO_SIDED|95.0|-1.67|2.2||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||2.20|-1.67|0.7860
91636472|NCT03451630|183165224|SUPERIORITY|||||||0.59||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.59
91636473|NCT03451630|183165224|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6692|TWO_SIDED|95.0|0.76|2.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||2.11|0.76|0.6692
91636474|NCT03451630|183165224|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6692|TWO_SIDED|95.0|0.7|1.93||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.80 with degrees of freedom (2).||Test for the Treatment Effect||1.93|0.70|0.6692
91636475|NCT03451630|183165224|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6692|TWO_SIDED|95.0|0.75|1.59||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||1.59|0.75|0.6692
91636476|NCT03451630|183165225|SUPERIORITY|||||||0.58||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.58
91714971|NCT03205150|183321265|SUPERIORITY||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|1.45||0.235|TWO_SIDED|80.0|-3.6|0.14|||ANCOVA|||||0.14|-3.60|0.235
91714972|NCT03205150|183321265|SUPERIORITY||Mean Difference (Net)|-4.26|STANDARD_ERROR_OF_MEAN|1.46||0.004|TWO_SIDED|80.0|-6.14|-2.37|||ANCOVA|||||-2.37|-6.14|0.004
91714973|NCT03205150|183321265|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.19||0.037|TWO_SIDED|80.0|0.98|4.07|||ANCOVA|||||4.07|0.98|0.037
91714974|NCT03205150|183321266|SUPERIORITY||Mean Difference (Net)|-3.15|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|80.0|-4.22|-2.08|||ANCOVA|||||-2.08|-4.22|<.001
91714975|NCT03205150|183321266|SUPERIORITY||Mean Difference (Net)|-4.18|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|80.0|-5.28|-3.08|||ANCOVA|||||-3.08|-5.28|<.001
91714976|NCT03205150|183321266|SUPERIORITY||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.71||0.148|TWO_SIDED|80.0|0.12|1.94|||ANCOVA|||||1.94|0.12|0.148
91636477|NCT03451630|183165225|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7436|TWO_SIDED|95.0|0.43|3.02||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect||3.02|0.43|0.7436
91636478|NCT03451630|183165225|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7436|TWO_SIDED|95.0|0.31|2.25||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.25|0.31|0.7436
91636479|NCT03451630|183165225|SUPERIORITY||Odds Ratio (OR)|1.36||||0.7436|TWO_SIDED|95.0|0.62|2.97|||Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.97|0.62|0.7436
91636480|NCT03451630|183165226|SUPERIORITY|||||||0.5558||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.82 with degrees of freedom (6, 3057)||Overall test of treatment-by-time interaction||||0.5558
91636481|NCT03451630|183165226|SUPERIORITY|||||||0.0002||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 6.74 with degrees of freedom (3, 3063).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0002
91636482|NCT03451630|183165226|SUPERIORITY|||||||0.7846||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.24 with degrees of freedom (2,1197).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.7846
91636483|NCT03451630|183165226|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.2444|TWO_SIDED|95.0|-1.92|0.49||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-Statistics 1.36 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.49|-1.92|0.2444
91636484|NCT03451630|183165226|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.61||0.648|TWO_SIDED|95.0|-1.48|0.92||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.21 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.92|-1.48|0.6480
91636485|NCT03451630|183165226|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.46||0.3476|TWO_SIDED|95.0|-1.34|0.47||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.47|-1.34|0.3476
91636486|NCT03451630|183165227|SUPERIORITY|||||||0.5199||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.86 with degrees of freedom (6, 3148)||Overall test of treatment-by-time||||0.5199
91636487|NCT03451630|183165227|SUPERIORITY|||||||0.0008||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.56 with degrees of freedom (3, 3154).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0008
91636488|NCT03451630|183165227|SUPERIORITY|||||||0.9897||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.01 with degrees of freedom (2,1229).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9897
91636489|NCT03451630|183165227|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8749|TWO_SIDED|95.0|-0.03|0.03||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.03|-0.03|0.8749
91636490|NCT03451630|183165227|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.2216|TWO_SIDED|95.0|-0.05|0.01||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.49 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.01|-0.05|0.2216
91636491|NCT03451630|183165227|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.0607|TWO_SIDED|95.0|0.0|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.52 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.04|0.00|0.0607
91714977|NCT03205150|183321274|SUPERIORITY||Mean Difference (Net)|-11.15|STANDARD_ERROR_OF_MEAN|4.36||0.013|TWO_SIDED|80.0|-16.79|-5.5|||ANCOVA|||||-5.50|-16.79|0.013
91714978|NCT03205150|183321274|SUPERIORITY||Mean Difference (Net)|-14.71|STANDARD_ERROR_OF_MEAN|4.43||0.001|TWO_SIDED|80.0|-20.43|-8.98|||ANCOVA|||||-8.98|-20.43|0.001
91792703|NCT01293799|183463114|OTHER||Hazard Ratio (HR)|1.13||||0.48|TWO_SIDED|95.0|0.81|1.57||Unit of measure: Functional status (Karnofsky score 80 - 90 vs. 100). Functional status was estimated by the Karnofsky Performance Scale (see Statistical analysis 1). P \< 0.05 is regarded as statistically significant.|Regression, Cox|Univariable Cox regression||"The association of Functional status (Karnofsky score 80 - 90 vs. 100) with time to first peritonitis episode was analysed by univariable Cox regression."||1.57|0.81|0.48
91636492|NCT03451630|183165228|SUPERIORITY|||||||0.1884||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.46 with degrees of freedom (6, 3138)||Overall test of treatment-by-time||||0.1884
91636493|NCT03451630|183165228|SUPERIORITY|||||||0.009||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.87 with degrees of freedom (3, 3144).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0090
91636494|NCT03451630|183165228|SUPERIORITY|||||||0.217||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.53 with degrees of freedom (2, 1227).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.2170
91636495|NCT03451630|183165228|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.191|TWO_SIDED|95.0|-0.06|0.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.71 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.28|-0.06|0.1910
91636496|NCT03451630|183165228|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.0229|TWO_SIDED|95.0|0.03|0.35||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.18 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.35|0.03|0.0229
91636497|NCT03451630|183165228|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.2547|TWO_SIDED|95.0|-0.21|0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.30 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.06|-0.21|0.2547
91636498|NCT03451630|183165229|SUPERIORITY|||||||0.0413||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.0413
91636499|NCT03451630|183165229|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1433|TWO_SIDED|95.0|-0.28|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.14 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.04|-0.28|0.1433
91636500|NCT03451630|183165229|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4272|TWO_SIDED|95.0|-0.1|0.23||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.63 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.23|-0.10|0.4272
91636501|NCT03451630|183165229|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0037|TWO_SIDED|95.0|-0.31|-0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 8.45 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||-0.06|-0.31|0.0037
91636502|NCT03451630|183165230|SUPERIORITY|||||||0.8231||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.8231
91714979|NCT03205150|183321274|SUPERIORITY||Mean Difference (Net)|3.56|STANDARD_ERROR_OF_MEAN|3.65||0.332|TWO_SIDED|80.0|-1.15|8.28|||ANCOVA|||||8.28|-1.15|0.332
91714980|NCT01095835|183321275|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
91714981|NCT03028142|183321286|OTHER||LS Means ratio|1.05||||0.0022|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0022
91714982|NCT03028142|183321286|OTHER||LS Means ratio|1.09|||<|0.0001|TWO_SIDED|95.0|1.05|1.12|||ANCOVA|||||1.12|1.05|<0.0001
91714983|NCT03028142|183321287|OTHER||LS Means ratio|1.03||||0.0988|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.0988
91714984|NCT03028142|183321287|OTHER||LS Means ratio|1.06||||0.0009|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0009
91714985|NCT03028142|183321288|OTHER||LS Means ratio|1.02||||0.2496|TWO_SIDED|95.0|0.98|1.06|||ANCOVA|||||1.06|0.98|0.2496
91714986|NCT03028142|183321288|OTHER||LS Means ratio|1.06||||0.0039|TWO_SIDED|95.0|1.02|1.1|||ANCOVA|||||1.1|1.02|0.0039
91714987|NCT03028142|183321289|OTHER||LS Means ratio|1.03||||0.1404|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.1404
91636503|NCT03451630|183165230|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 330.05 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
91792704|NCT01293799|183463114|OTHER|Univariable Cox regression|Hazard Ratio (HR)|1.13||||0.63|TWO_SIDED|95.0|0.69|1.85||Unit of measure: Functional status (Karnofsky score \< 80 vs. 100). Functional status was estimated by the Karnofsky Performance Scale (see Statistical analysis 1). P \< 0.05 is regarded as statistically significant.|Regression, Cox|||"The association of Functional status (Karnofsky score \< 80 vs. 100) with time to first peritonitis episode was analysed by univariable Cox regression."||1.85|0.69|0.63
91636504|NCT03451630|183165230|SUPERIORITY|||||||0.6061||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.50 with degrees of freedom (2 , 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.6061
91636505|NCT03451630|183165230|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7459|TWO_SIDED|95.0|-0.15|0.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.11|-0.15|0.7459
91636506|NCT03451630|183165230|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3169|TWO_SIDED|95.0|-0.18|0.08||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.00 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.08|-0.18|0.3169
91636507|NCT03451630|183165230|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.4098|TWO_SIDED|95.0|-0.07|0.14||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.68 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.14|-0.07|0.4098
91636508|NCT03451630|183165231|SUPERIORITY|||||||0.4732||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (4, 1945).||Overall test for the treatment-by-time interaction||||0.4732
91636509|NCT03451630|183165231|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 319.14 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
91636510|NCT03451630|183165231|SUPERIORITY|||||||0.9628||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (2, 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9628
91714988|NCT03028142|183321289|OTHER||LS Means ratio|1.04||||0.0228|TWO_SIDED|95.0|1.01|1.08|||ANCOVA|||||1.08|1.01|0.0228
91714989|NCT01298700|183321333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.148|TWO_SIDED|95.0|-11.0|1.9||P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).|Cochran-Mantel-Haenszel||bimatoprost 0.01% ophthalmic solution - bimatoprost 0.03% ophthalmic solution|||1.9|-11|0.148
91714990|NCT00129441|183321335|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
91714991|NCT00129441|183321336|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||ANOVA|||||||0.162
91792705|NCT01293799|183463115|OTHER||Hazard Ratio (HR)|0.9||||0.71|TWO_SIDED|95.0|0.54|1.53||Unit of measure: Visual impairment (yes vs. no). P-value \< 0.05 is regarded as statistically significant.|Regression, Cox|||"The association of the Social Factor Visual Impairment (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.53|0.54|0.71
91714992|NCT00129441|183321337|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
91714993|NCT00129441|183321338|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
91714994|NCT00129441|183321339|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||ANOVA|||||||0.249
91714995|NCT00129441|183321340|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.||||0.01
91714996|NCT00129441|183321341|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91714997|NCT00129441|183321342|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91669657|NCT01525628|183233950|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.29|STANDARD_DEVIATION|34.3||0.5658|TWO_SIDED|90.0|62.5|98.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||98.07|62.50|0.5658
91669658|NCT01525628|183233950|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|108.25|STANDARD_DEVIATION|37.2||0.1286|TWO_SIDED|90.0|87.46|133.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||133.99|87.46|0.1286
91669659|NCT01525628|183233950|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|87.59|STANDARD_DEVIATION|31.8||0.1898|TWO_SIDED|90.0|73.56|104.3|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||104.30|73.56|0.1898
91669660|NCT01525628|183233950|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.42|STANDARD_DEVIATION|36.3||0.5575|TWO_SIDED|90.0|61.81|99.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||99.51|61.81|0.5575
91669661|NCT00243152|183233993|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.||||<0.05
91669662|NCT00243152|183233993|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.||||>0.05
91669663|NCT00243152|183233993|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.||||>0.05
91669664|NCT00243152|183233993|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.||||>0.05
91714998|NCT04006145|183321343|SUPERIORITY||LS-Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.184||0.029|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Change from baseline in serum LDL-C at Week 16 was analyzed using ANCOVA after the missing data imputation, with treatment group as a factor, baseline serum LDL-C, baseline LDL-C-by-treatment interaction values, and baseline lipid-lowering medications (Yes or No) as covariates. Missing data for serum LDL-C was imputed through multiple imputation method as described in the statistical analysis plan (SAP).||-0.04|-0.76|0.029
91714999|NCT01001429|183321344|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||||||0.04
91715000|NCT01001429|183321344|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Regression, Linear|||UMSS scores with subjects propofol vs. Dexmetomidine group||||0.68
91792706|NCT01293799|183463116|OTHER||Hazard Ratio (HR)|1.29||||0.29|TWO_SIDED|95.0|0.8|2.06||"Unit of measure: Impaired Hand Function (yes vs. no). P-value \< 0.05 is considered statistically significant."|Regression, Cox|Univariable Cox regression||"The association of Impaired Hand Function (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||2.06|0.80|0.29
91669665|NCT00243152|183233993|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.||||>0.05
91669666|NCT00243152|183233993|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.||||>0.05
91715001|NCT02812186|183321365|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91669667|NCT00401245|183233995|SUPERIORITY_OR_OTHER|||||||0.024||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.024
91669668|NCT00401245|183233996|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||< 0.001
91669669|NCT00401245|183233996|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
91669670|NCT00401245|183233996|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
91715002|NCT02812186|183321366|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
91715003|NCT02812186|183321367|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91792707|NCT01293799|183463117|OTHER||Hazard Ratio (HR)|0.68||||0.016|TWO_SIDED|95.0|0.5|0.93||"Units of measure: Working full or part time (yes vs no). P-value \< 0.05 is considered significant."|Regression, Cox|Univariable Cox regression||"The association of Working Full or Part Time (yes vs. no) with time to first peritonitis episode analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found."||0.93|0.50|0.016
91485183|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.47|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.26|0.47
91636511|NCT03451630|183165231|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.8438|TWO_SIDED|95.0|-0.16|0.19||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.19|-0.16|0.8438
91636512|NCT03451630|183165231|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7425|TWO_SIDED|95.0|-0.19|0.15||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.15|-0.19|0.7425
91636513|NCT03451630|183165231|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5044|TWO_SIDED|95.0|-0.1|0.17||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.45 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.17|-0.10|0.5044
91636514|NCT03451630|183165232|SUPERIORITY|||||||0.9804||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9804
91636515|NCT03451630|183165232|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 21.80 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
91636516|NCT03451630|183165232|SUPERIORITY|||||||0.9764||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (2, 1211).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9764
91636517|NCT03451630|183165232|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9757|TWO_SIDED|95.0|0.63|1.6||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.03.||Odds ratio of Treatment at 12-Months||1.60|0.63|0.9757
91636518|NCT03451630|183165232|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7958|TWO_SIDED|95.0|0.67|1.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.26.||Odds ratio of Treatment at 12-Months||1.68|0.67|0.7958
91669671|NCT00401245|183233997|SUPERIORITY_OR_OTHER|||||||0.092||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.092
91669672|NCT00401245|183233997|SUPERIORITY_OR_OTHER|||||||0.997||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.997
91669673|NCT00401245|183233997|SUPERIORITY_OR_OTHER|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.009
91669674|NCT00401245|183233998|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.078
91669675|NCT00401245|183233998|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.005
91669676|NCT00401245|183233998|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.929
91669677|NCT00401245|183234000|SUPERIORITY_OR_OTHER|||||||0.017||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.017
91669678|NCT00401245|183234007|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.||||<0.001
91669679|NCT00401245|183234007|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.||||< 0.001
91669680|NCT00401245|183234007|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.||||<0.001
91669681|NCT00401245|183234007|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.||||<0.001
91669682|NCT00951093|183234046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P value adjusted for multiple comparisons|Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||<0.001
91669683|NCT00951093|183234047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||0.002
91669684|NCT00951093|183234048|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|||||||< 0.001
91669685|NCT00951093|183234049|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.020
91669686|NCT00951093|183234050|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.001
91669687|NCT00951093|183234051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||0.001
91669688|NCT00951093|183234052|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||< 0.001
91669689|NCT00996437|183234053|SUPERIORITY_OR_OTHER||Treatment Difference in Cumulative Prob|4.0||||0.37|TWO_SIDED|95.0|-4.0|13.0|||Log Rank|After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.||The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.||13|-4|0.37
91669690|NCT00996437|183234054|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.|Fisher Exact|||||||0.01
91669691|NCT00996437|183234055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.05|TWO_SIDED|95.0|1.03|2.3|||Log Rank|||||2.30|1.03|0.05
91669692|NCT00996437|183234056|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value corresponds to the 12 week visit treatment comparison.|GLM with GEE method|Number of subjects with baseline OCT ss=0 and OCT ss\>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.||Signal strength was analyzed as a composite outcome defined as OCT signal strength \> = and no vitrectomy vs. OCT signal strength = 0.||||0.87
91669693|NCT00996437|183234057|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value corresponds to the 12 week visit treatment comparison.|Mixed Models Analysis|Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.||||||.04
91669694|NCT00996437|183234059|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value corresponds with the 12 week visit treatment comparison|Fisher Exact|At the each time point, treatment comparison analysis was performed using a Fisher Exact test.||||||.023
91669695|NCT00996437|183234060|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Fisher Exact|At each time point, treatment comparison analysis was performed using a Fisher Exact Test.||||||0.27
91669696|NCT02156154|183234135|SUPERIORITY||Median Difference (Final Values)|-0.04||||0.29|TWO_SIDED|95.0|-0.18|0.11||significance criterion of P \< .044.|Wilcoxon (Mann-Whitney)||Difference = IV Acetaminophen - Placebo group|A total of 28 patients (5%) were missing monitoring data (14 patients in each group). Values for these patients were obtained using multivariable imputation with 5 imputation data sets. The imputation regression model included all of the baseline, intraoperative, surgical, and postanesthesia care unit variables and all of the secondary outcomes||0.11|-0.18|0.29
91669697|NCT02156154|183234136|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.07|TWO_SIDED|99.4|-0.71|0.15||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.15|-0.71|0.07
91669698|NCT02156154|183234137|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.46|TWO_SIDED|99.4|-0.51|0.29||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.29|-0.51|0.46
91669699|NCT02156154|183234138|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.56|TWO_SIDED|99.4|-0.49|0.76||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.76|-0.49|0.56
91669700|NCT02156154|183234139|SUPERIORITY||Mean Difference (Net)|-0.08||||0.3|TWO_SIDED|99.4|-0.29|0.13||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.13|-0.29|0.30
91669701|NCT02156154|183234140|SUPERIORITY||Ratios of geometric means|0.94||||0.65|TWO_SIDED|99.4|0.63|1.39||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.39|0.63|0.65
91669702|NCT02156154|183234141|SUPERIORITY||Ratios of geometric means|0.86||||0.22|TWO_SIDED|99.4|0.61|1.21|||t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.21|0.61|0.22
91792708|NCT01293799|183463118|OTHER||Hazard Ratio (HR)|1.32||||0.041|TWO_SIDED|95.0|1.01|1.73||"Unit of measure: Retired (yes vs. no). P-value \< 0.05 is considered significant."|Regression, Cox|Univariable Cox regression||"The association of being retired (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found."||1.73|1.01|0.041
91792709|NCT01293799|183463119|OTHER||Hazard Ratio (HR)|1.31||||0.064|TWO_SIDED|95.0|0.98|1.76||"Unit of measure: Living alone (yes vs. no). P-value \< 0.05 is considered significant."|Regression, Cox|Univariable Cox regression||"The association of Living alone (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.76|0.98|0.064
91636519|NCT03451630|183165232|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7646|TWO_SIDED|95.0|0.67|1.34||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.30||Odds ratio of Treatment at 12-Months||1.34|0.67|0.7646
91792710|NCT01293799|183463120|OTHER||Hazard Ratio (HR)|0.48||||0.14|TWO_SIDED|95.0|0.18|1.29||"Unit of measure: Need for translation/interpreter (yes vs. no). P-value \< 0.05 is considered significant."|Regression, Cox|Univariable Cox regression||"The association of Need for translation/interpreter with time to first peritonitis episode was analysed by univariable Cox regression."||1.29|0.18|0.14
91525975|NCT03502616|182927258|SUPERIORITY||LS mean difference|3.26|STANDARD_ERROR_OF_MEAN|0.549|<|0.0001|TWO_SIDED|95.0|2.18|4.34|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.34|2.18|<0.0001
91636520|NCT03451630|183165233|SUPERIORITY|||||||0.9622||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.15 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9622
91636521|NCT03451630|183165233|SUPERIORITY|||||||0.0377||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.28 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0377
91636522|NCT03451630|183165233|SUPERIORITY|||||||0.83||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistic 0.19 with degrees of freedom (2, 1903).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.8300
91636523|NCT03451630|183165233|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7507|TWO_SIDED|95.0|0.38|2.0||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.32||Odds ratio of Treatment at 12-Months||2.00|0.38|0.7507
91669703|NCT02156154|183234142|SUPERIORITY||Risk Ratio (RR)|1.13||||0.18|TWO_SIDED|99.4|0.88|1.45||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||Risk ratio = Treatment/Placebo|||1.45|0.88|0.18
91669704|NCT02156154|183234143|SUPERIORITY||Risk Ratio (RR)|0.9||||0.53|TWO_SIDED|99.4|0.57|1.43||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||RR = Treatment/Placebo|||1.43|0.57|0.53
91669705|NCT02156154|183234144|SUPERIORITY||Median Difference (Final Values)|0.0||||0.99|TWO_SIDED|99.4|-0.39|0.36||Adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Wilcoxon (Mann-Whitney)||Treatment effect is reported as median difference, estimated using the Hodges-Lehmann estimator of location shift.|||0.36|-0.39|0.99
91669706|NCT02051595|183234145|SUPERIORITY_OR_OTHER||estimate (beta) from mixed model|-0.068|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|-0.098|-0.039||A priori threshold was set to p \< 0.05.|Mixed Models Analysis|Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.|Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).|||-0.039|-0.098|<0.0001
91669707|NCT01729026|183234177|SUPERIORITY_OR_OTHER_LEGACY||Effect size (Cohen's d)|-0.75||||0.141|TWO_SIDED|95.0|-1.85|0.35||Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.|Mixed effects regression models|||The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.||0.35|-1.85|0.141
91669708|NCT01729026|183234178|SUPERIORITY||effect size (Cohen's d)|0.0||||0.982|TWO_SIDED||||||effect size (Cohen's d)|||||||0.982
91669709|NCT01729026|183234179|SUPERIORITY||effect size (Cohen's d)|-0.5||||0.16|TWO_SIDED||||||effect size (Cohen's d)|||||||0.160
91669710|NCT01729026|183234180|SUPERIORITY||effect size (Cohen's d)|-1.36||||0.015|TWO_SIDED|95.0|-2.49|-0.23|||effect size (Cohen's d)|||||-0.23|-2.49|0.015
91669711|NCT01729026|183234181|SUPERIORITY||effect size (Cohen's d)|0.2||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
91669712|NCT01729026|183234182|SUPERIORITY||mixed effects regression models|-1.41||||0.01|TWO_SIDED|95.0|-2.5|-0.31|||effect size (Cohen's d)|||||-0.31|-2.50|0.010
91669713|NCT01729026|183234183|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
91669714|NCT01729026|183234184|SUPERIORITY||effect size (Cohen's d)|0.9||||0.188|TWO_SIDED||||||effect size (Cohen's d)|||||||0.188
91669715|NCT01729026|183234186|SUPERIORITY||effect size (Cohen's d)|1.2||||0.031|TWO_SIDED||||||mixed effects regression models|||||||0.031
91636524|NCT03451630|183165233|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8844|TWO_SIDED|95.0|0.42|2.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.15||Odds ratio of Treatment at 12-Months||2.13|0.42|0.8844
91669716|NCT01729026|183234187|SUPERIORITY||effect size (Cohen's d)|0.3||||0.541|TWO_SIDED|95.0|-0.8|1.4|||effect size (Cohen's d)|||||1.40|-0.80|0.541
91669717|NCT01729026|183234188|SUPERIORITY||effect size (Cohen's d)|0.6||||0.139|TWO_SIDED||||||effect size (Cohen's d)|||Please note that a minus number indicates an increase in pain ratings.||||0.139
91669718|NCT00407745|183234198|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.198||0.0032|TWO_SIDED|95.0|-0.98|-0.2||Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.|ANCOVA|||"Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors."||-0.20|-0.98|0.0032
91669719|NCT00407745|183234199|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.255||0.0066|TWO_SIDED|95.0|-1.2|-0.2||Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (\<=0.05).|ANCOVA|ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.20|-1.20|0.0066
91669720|NCT00407745|183234200|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.039|TWO_SIDED|95.0|1.032|3.328||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Regression, Logistic|Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group||3.328|1.032|0.0390
91669721|NCT00407745|183234201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0||||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Cochran-Mantel-Haenszel|Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.||Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.||||0.0006
91669722|NCT00407745|183234202|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.265|<|0.0001|TWO_SIDED|95.0|-1.6|-0.56||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|ANCOVA|ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.56|-1.60|<0.0001
91669723|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.0295|TWO_SIDED|95.0|-0.94|-0.05||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.05|-0.94|0.0295
91669724|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0033|TWO_SIDED|95.0|-1.11|-0.22||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.22|-1.11|0.0033
91669725|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.23||0.0185|TWO_SIDED|95.0|-0.98|-0.09||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.09|-0.98|0.0185
91669726|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.10|0.0040
91669727|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23||0.0004|TWO_SIDED|95.0|-1.26|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.26|0.0004
91669728|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0018|TWO_SIDED|95.0|-1.17|-0.27||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.27|-1.17|0.0018
91669729|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0027|TWO_SIDED|95.0|-1.14|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.14|0.0027
91669730|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.11|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.11|0.0041
91669731|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.18|-1.09|0.0058
91669732|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0031|TWO_SIDED|95.0|-1.14|-0.23||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.23|-1.14|0.0031
91669733|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.23||0.0076|TWO_SIDED|95.0|-1.08|-0.17||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.17|-1.08|0.0076
91669734|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0328|TWO_SIDED|95.0|-0.95|-0.04||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.04|-0.95|0.0328
91669735|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.02|-0.11||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.11|-1.02|0.0150
91669736|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0048|TWO_SIDED|95.0|-1.11|-0.2||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.20|-1.11|0.0048
91669737|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.15|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.15|0.0030
91636525|NCT03451630|183165233|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8227|TWO_SIDED|95.0|0.49|1.77||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.22||Odds ratio of Treatment at 12-Months||1.77|0.49|0.8227
91636526|NCT03451630|183165234|OTHER|||||||1|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1a||||1.00
91669738|NCT00407745|183234203|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0011|TWO_SIDED|95.0|-1.22|-0.3||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.30|-1.22|0.0011
91669739|NCT00407745|183234204|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.0256|TWO_SIDED|95.0|1.103|4.546||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.||4.546|1.103|0.0256
91669740|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.23|-0.35||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.35|-1.23|0.0004
91669741|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.43||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.43|-1.31|<0.0001
91669742|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.24|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.24|0.0004
91669743|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0008|TWO_SIDED|95.0|-1.2|-0.32||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.32|-1.20|0.0008
91669744|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.38|<0.0001
91669745|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.48||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.48|-1.37|<0.0001
91669746|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.35|<0.0001
91669747|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.46||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.46|-1.35|<0.0001
91792711|NCT01293799|183463121|OTHER||Hazard Ratio (HR)|1.11||||0.6|TWO_SIDED|95.0|0.75|1.65||"Unit of measure: Current smoking (yes vs. no). P-value \< 0.05 is considered significant."|Regression, Cox|Univariable Cox regression||"The association of Current smoking (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.65|0.75|0.60
91669748|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.5||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.50|-1.39|<0.0001
91669749|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
91636527|NCT03451630|183165234|OTHER|||||||0.242|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1b||||0.242
91636528|NCT03451630|183165235|OTHER|||||||0.1112|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-1||||0.1112
91636529|NCT03451630|183165235|OTHER|||||||0.4754|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-2||||0.4754
91636530|NCT03451630|183165236|SUPERIORITY||Odds Ratio (OR)|0.74||||0.9079|TWO_SIDED|95.0|0.13|4.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||4.28|0.13|0.9079
91636531|NCT03451630|183165236|SUPERIORITY||Odds Ratio (OR)|0.68||||0.9079|TWO_SIDED|95.0|0.13|3.72||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.72|0.13|0.9079
91636532|NCT03451630|183165236|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9079|TWO_SIDED|95.0|0.34|3.45||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.45|0.34|0.9079
91636533|NCT03451630|183165237|SUPERIORITY|||||||0.9912||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (4, 335).||Test for the treatment-by-time interaction (without weight) for SPC-1.||||0.9912
91636534|NCT03451630|183165237|SUPERIORITY|||||||0.876||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 339).||Test for change over time for SPC-1||||0.8760
91636535|NCT03451630|183165237|SUPERIORITY|||||||0.678||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.39 with degrees of freedom (2, 276).||Test for change in treatment effect for SPC-1||||0.6780
91636536|NCT03451630|183165237|SUPERIORITY|||||||0.1761||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.59 with degrees of freedom (4, 284).||Test for the treatment-by-time interaction (without weight) for SPC-2||||0.1761
91636537|NCT03451630|183165237|SUPERIORITY|||||||0.3239||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.13 with degrees of freedom (2, 288).||Test for change over time for SPC-2||||0.3239
91636538|NCT03451630|183165237|SUPERIORITY|||||||0.7415||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.30 with degrees of freedom (2, 139).||Test for change in treatment effect for SPC-2||||0.7415
91636539|NCT03451630|183165238|SUPERIORITY|||||||0.9786||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 608).||Test for the treatment-by-time interaction (without weight) for SPD-1.||||0.9786
91636540|NCT03451630|183165238|SUPERIORITY|||||||0.4703||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.76 with degrees of freedom (2, 612).||Test for change over time for SPD-1||||0.4703
91792712|NCT01293799|183463122|OTHER||Hazard Ratio (HR)|0.96||||0.18|TWO_SIDED|95.0|0.9|1.02||"Unit of measure: Serum creatinine (HR per 100 micromol/L. P-value \< 0.05 is considered significant."|Regression, Cox|Univariable Cox regression||"The association of Serum creatinine (Hazard ratio per 100 micromol/L with time to first peritonitis episode was analysed by univariable Cox regression."||1.02|0.90|0.18
91669750|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.39|<0.0001
91669751|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.37|<0.0001
91669752|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.38|<0.0001
91669753|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.41|-0.51||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.51|-1.41|<0.0001
91669754|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
91669755|NCT00407745|183234205|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.51|-0.61||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.61|-1.51|<0.0001
91669756|NCT00407745|183234206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.269||0.0438|TWO_SIDED|95.0|-1.08|-0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.02|-1.08|0.0438
91669757|NCT00407745|183234207|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.448||0.7103|TWO_SIDED|95.0|-1.06|0.72||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.72|-1.06|0.7103
91669758|NCT00407745|183234207|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.0747|TWO_SIDED|95.0|-1.28|0.06||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.06|-1.28|0.0747
91792713|NCT01293799|183463123|OTHER||Hazard Ratio (HR)|0.96||||0.34|TWO_SIDED|95.0|0.9|1.04||Unit of measure: Serum urea (Hazard ratio per 5 mmol/L). P-value \< 0.05 is considered significant.|Regression, Cox|Univariable Cox regression||"The association of Serum urea (Hazard ratio per 5 mmol/l) with time to first peritonitis episode was analysed by univariable Cox regression."||1.04|0.90|0.34
91527846|NCT06173570|182930691|SUPERIORITY||Mean Difference (Net)|-26.27|||<|0.001|TWO_SIDED|95.0|-31.37|-21.18|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-21.18|-31.37|< 0.001
91715004|NCT00643760|183321379|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.35||||0.295||95.0|-1.02|0.31||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.31|-1.02|0.295
91669759|NCT00407745|183234208|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.379||0.5689|TWO_SIDED|95.0|-0.97|0.54||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.54|-0.97|0.5689
91715005|NCT00643760|183321379|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.02||||0.946||95.0|-0.71|0.66||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.66|-0.71|0.946
91715006|NCT00643760|183321379|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.55||||0.105||95.0|-1.1|0.01||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.01|-1.10|0.105
91669760|NCT00407745|183234208|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.322||0.4764|TWO_SIDED|95.0|-0.87|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-0.87|0.4764
91669761|NCT00407745|183234209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.474||0.3362|TWO_SIDED|95.0|-1.4|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.40|0.3362
91715007|NCT00643760|183321379|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.43||||||95.0|-0.22|1.08||||||||1.08|-0.22|
91715008|NCT00789321|183321404|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||0.001||90.0|-18.1|-5.4|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||-5.4|-18.1|0.001
91715009|NCT00789321|183321405|SUPERIORITY_OR_OTHER||Least Squares Mean|39.0||||0.001||95.0|17.9|60.1|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||60.1|17.9|0.001
91715010|NCT00104052|183321406|SUPERIORITY_OR_OTHER||Normal approximation to the binomial|0.654||||||95.0|0.564|0.744||||||||0.744|0.564|
91525976|NCT03502616|182927258|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|1.93|4.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.15|1.93|<0.0001
91715011|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-1.54||||0.2968|TWO_SIDED|95.0|-4.44|1.37|||Student's paired t-test|||Change from Baseline at Day 1||1.37|-4.44|0.2968
91715012|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-15.36|||<|0.0001|TWO_SIDED|95.0|-19.77|-10.95|||Student's paired t-test|||Change from Baseline at Day 2||-10.95|-19.77|<.0001
91715013|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-27.27|||<|0.0001|TWO_SIDED|95.0|-33.06|-21.49|||Student's paired t-test|||Change from Baseline at Day 3||-21.49|-33.06|<.0001
91715014|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-35.05|||<|0.0001|TWO_SIDED|95.0|-41.69|-28.41|||Student's paired t-test|||Change from Baseline at Day 4||-28.41|-41.69|<.0001
91715015|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-38.49|||<|0.0001|TWO_SIDED|95.0|-45.87|-31.11|||Student's paired t-test|||Change from Baseline at Day 5||-31.11|-45.87|<.0001
91715016|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-39.67|||<|0.0001|TWO_SIDED|95.0|-48.46|-30.88|||Student's paired t-test|||Change from Baseline at Day 6||-30.88|-48.46|<.0001
91715017|NCT05556148|183321413|OTHER||Mean Difference (Final Values)|-52.6|||<|0.0001|TWO_SIDED|95.0|-63.69|-41.51|||Student's paired t-test|||Change from Baseline at Day 7||-41.51|-63.69|<.0001
91715018|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|0.29||||0.7112|TWO_SIDED|95.0|-1.27|1.86|||Student's paired t-test|||Change from Baseline at Day 1||1.86|-1.27|0.7112
91715019|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|-6.21|||<|0.0001|TWO_SIDED|95.0|-8.51|-3.92|||Student's paired t-test|||Change from Baseline at Day 2||-3.92|-8.51|<.0001
91715020|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|-12.11|||<|0.0001|TWO_SIDED|95.0|-15.0|-9.22|||Student's paired t-test|||Change from Baseline at Day 3||-9.22|-15.00|<.0001
91715021|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|-15.98|||<|0.0001|TWO_SIDED|95.0|-19.24|-12.71|||Student's paired t-test|||Change from Baseline at Day 4||-12.71|-19.24|<.0001
91715022|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|-19.44|||<|0.0001|TWO_SIDED|95.0|-23.29|-15.59|||Student's paired t-test|||Change from Baseline at Day 5||-15.59|-23.29|<.0001
91715023|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|-19.36|||<|0.0001|TWO_SIDED|95.0|-24.03|-14.69|||Student's paired t-test|||Change from Baseline at Day 6||-14.69|-24.03|<.0001
91715024|NCT05556148|183321414|OTHER||Mean Difference (Final Values)|-25.4|||<|0.0001|TWO_SIDED|95.0|-31.87|-18.93|||Student's paired t-test|||Change from Baseline at Day 7||-18.93|-31.87|<.0001
91715025|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-1.83||||0.0481|TWO_SIDED|95.0|-3.64|-0.02|||Student's paired t-test|||Change from Baseline at Day 1||-0.02|-3.64|0.0481
91485184|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.056|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.26|0.056
91636541|NCT03451630|183165238|SUPERIORITY|||||||0.877||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 332).||Test for change in treatment effect for SPD-1||||0.8770
91636542|NCT03451630|183165238|SUPERIORITY|||||||0.6198||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.66 with degrees of freedom (4, 469).||Test for the treatment-by-time interaction (without weight) for SPD-2||||0.6198
91636543|NCT03451630|183165238|SUPERIORITY|||||||0.6211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.48 with degrees of freedom (2, 473).||Test for change over time for SPD-2||||0.6211
91636544|NCT03451630|183165238|SUPERIORITY|||||||0.1471||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.93 with degrees of freedom (2, 219).||Test for change in treatment effect for SPD-2.||||0.1471
91636545|NCT03451630|183165239|SUPERIORITY|||||||0.8247||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-1||||0.8247
91636546|NCT03451630|183165239|SUPERIORITY|||||||0.6651||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.41 with degrees of freedom (2, 284).||Test for change over time for AMM-1||||0.6651
91636547|NCT03451630|183165239|SUPERIORITY|||||||0.3441||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.07 with degrees of freedom (2, 218).||Test for change in treatment effect for AMM-1||||0.3441
91636548|NCT03451630|183165239|SUPERIORITY|||||||0.0847||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.07 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-2||||0.0847
91636549|NCT03451630|183165239|SUPERIORITY|||||||0.9695||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.03 with degrees of freedom (2, 284).||Test for change over time for AMM-2||||0.9695
91636550|NCT03451630|183165239|SUPERIORITY|||||||0.9396||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.06 with degrees of freedom (2, 200).||Test for change in treatment effect for AMM-2||||0.9396
91636551|NCT02041533|183165244|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.2511|TWO_SIDED|95.0|0.91|1.45|||Log Rank|Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.|Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.45|0.91|0.2511
91636552|NCT02041533|183165245|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.43|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.43|0.95|
91636553|NCT02041533|183165246|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.20|0.79|
91636554|NCT02041533|183165247|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.86|1.24|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.24|0.86|
91636555|NCT02041533|183165248|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.06|||||Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.|||1.06|0.46|
91636556|NCT00545740|183165250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||Cochran-Mantel-Haenszel|||||||0.063
91636557|NCT00545740|183165250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0|||||Cochran-Mantel-Haenszel|||||||0.736
91669762|NCT00407745|183234209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.321||0.3113|TWO_SIDED|95.0|-0.96|0.31||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.31|-0.96|0.3113
91669763|NCT00407745|183234210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.539||0.2721|TWO_SIDED|95.0|-1.67|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.67|0.2721
91636558|NCT00545740|183165250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
91636559|NCT00545740|183165252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0|||||Cochran-Mantel-Haenszel|||||||0.047
91636560|NCT00545740|183165252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0|||||Cochran-Mantel-Haenszel|||||||0.741
91636561|NCT00545740|183165252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
91636562|NCT02117024|183165257|SUPERIORITY|||||||0.0011|||||||Log Rank|||||||0.0011
91636563|NCT02117024|183165257|OTHER||Hazard Ratio (HR)|1.0|||<|0.05|TWO_SIDED||||||Other|||With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.||||<0.05
91636564|NCT01646255|183165269|SUPERIORITY_OR_OTHER||Least Square Mean|-1.2|||=|0.0002|TWO_SIDED|95.0|-1.83|-0.57||Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.|ANCOVA|||"Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent off. The ANCOVA model contained treatment and (pooled) site as factors and Baseline off time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis."||-0.57|-1.83|=0.0002
91636565|NCT01468844|183165282|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|15.3|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636566|NCT01468844|183165283|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636567|NCT01468844|183165284|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636568|NCT01468844|183165285|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|-5.0|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636569|NCT01468844|183165286|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.|Mean Difference (Net)|-8.2|STANDARD_DEVIATION|4.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91669764|NCT00407745|183234210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.337||0.4906|TWO_SIDED|95.0|-0.43|0.9||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.90|-0.43|0.4906
91669765|NCT00407745|183234211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.472||0.3123|TWO_SIDED|95.0|-1.42|0.46||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.46|-1.42|0.3123
91715026|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-9.14|||<|0.0001|TWO_SIDED|95.0|-11.74|-6.55|||Student's paired t-test|||Change from Baseline at Day 2||-6.55|-11.74|<.0001
91669766|NCT00407745|183234211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.368||0.136|TWO_SIDED|95.0|-1.28|0.18||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.18|-1.28|0.1360
91715027|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-15.16|||<|0.0001|TWO_SIDED|95.0|-18.44|-11.88|||Student's paired t-test|||Change from Baseline at Day 3||-11.88|-18.44|<.0001
91636570|NCT01468844|183165287|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636571|NCT01468844|183165288|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636572|NCT01468844|183165289|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636573|NCT01468844|183165290|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|2.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636574|NCT01468844|183165291|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|3.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636575|NCT01468844|183165292|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|30.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636576|NCT01468844|183165293|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|39.3|STANDARD_DEVIATION|113.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91525977|NCT03502616|182927258|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.621||0.0028|TWO_SIDED|95.0|0.65|3.09|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.09|0.65|0.0028
91636577|NCT01468844|183165294|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|313.2|STANDARD_DEVIATION|267.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636578|NCT01468844|183165295|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|428.5|STANDARD_DEVIATION|146.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91669767|NCT00407745|183234212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.549||0.4257|TWO_SIDED|95.0|-1.53|0.65||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.65|-1.53|0.4257
91669768|NCT00407745|183234212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.412||0.2005|TWO_SIDED|95.0|-1.34|0.28||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.28|-1.34|0.2005
91669769|NCT00407745|183234213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.025||0.1377|TWO_SIDED|95.0|-0.09|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.01|-0.09|0.1377
91669770|NCT00407745|183234214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.038||0.3312|TWO_SIDED|95.0|-0.11|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.11|0.3312
91669771|NCT00407745|183234215|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.044|TWO_SIDED|95.0|-0.13|0.0||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.00|-0.13|0.0440
91669772|NCT00407745|183234216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.033||0.137|TWO_SIDED|95.0|-0.12|0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.02|-0.12|0.1370
91669773|NCT00407745|183234217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.028||0.8911|TWO_SIDED|95.0|-0.06|0.05||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.05|-0.06|0.8911
91669774|NCT00407745|183234218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.034||0.3731|TWO_SIDED|95.0|-0.1|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.10|0.3731
91715028|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-19.07|||<|0.0001|TWO_SIDED|95.0|-22.84|-15.3|||Student's paired t-test|||Change from Baseline at Day 4||-15.30|-22.84|<.0001
91636579|NCT01468844|183165296|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|119.0|STANDARD_DEVIATION|66.6|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91715029|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-19.05|||<|0.0001|TWO_SIDED|95.0|-23.35|-14.75|||Student's paired t-test|||Change from Baseline at Day 5||-14.75|-23.35|<.0001
91636580|NCT01468844|183165297|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636581|NCT01468844|183165297|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91669775|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.383||0.3312|TWO_SIDED|95.0|-1.13|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.13|0.3312
91669776|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0976|TWO_SIDED|95.0|-1.37|0.12||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.12|-1.37|0.0976
91669777|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.393||0.0538|TWO_SIDED|95.0|-1.54|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.01|-1.54|0.0538
91669778|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.389||0.3239|TWO_SIDED|95.0|-1.15|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.15|0.3239
91669779|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.376||0.1912|TWO_SIDED|95.0|-1.23|0.25||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.25|-1.23|0.1912
91669780|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.353||0.672|TWO_SIDED|95.0|-0.55|0.85||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.85|-0.55|0.6720
91669781|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.33||0.7821|TWO_SIDED|95.0|-0.74|0.56||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.56|-0.74|0.7821
91669782|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.352||0.6851|TWO_SIDED|95.0|-0.84|0.55||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.55|-0.84|0.6851
91669783|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.387||0.361|TWO_SIDED|95.0|-1.12|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-1.12|0.3610
91669784|NCT00407745|183234219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.402||0.4915|TWO_SIDED|95.0|-1.07|0.52||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.52|-1.07|0.4915
91715030|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-20.31|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.92|||Student's paired t-test|||Change from Baseline at Day 6||-14.92|-25.70|<.0001
91485185|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.117|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.117
91669785|NCT00407745|183234220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0536||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.0536
91669786|NCT00407745|183234221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3107||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.3107
91669787|NCT00407745|183234222|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|2.182||0.0262|TWO_SIDED|95.0|-9.19|-0.59||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.59|-9.19|0.0262
91669788|NCT00407745|183234223|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.985||0.0041|TWO_SIDED|95.0|-14.55|-2.78||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-2.78|-14.55|0.0041
91669789|NCT00407745|183234224|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|STANDARD_ERROR_OF_MEAN|3.492||0.0998|TWO_SIDED|95.0|-1.11|12.66||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.66|-1.11|0.0998
91669790|NCT00407745|183234225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.7|STANDARD_ERROR_OF_MEAN|3.501||0.1048|TWO_SIDED|95.0|-1.2|12.61||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.61|-1.20|0.1048
91669791|NCT00407745|183234226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.417||0.0347|TWO_SIDED|95.0|-9.91|-0.37||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.37|-9.91|0.0347
91669792|NCT00407745|183234227|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.189||0.0436|TWO_SIDED|95.0|0.01|0.76||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.76|0.01|0.0436
91669793|NCT00407745|183234228|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.77||0.2761|TWO_SIDED|95.0|-2.44|8.49||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||8.49|-2.44|0.2761
91669794|NCT00407745|183234229|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81||||0.0024|TWO_SIDED|95.0|1.443|5.491||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.||Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.||5.491|1.443|0.0024
91669795|NCT00407745|183234230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.433||0.1164|TWO_SIDED|95.0|-1.54|0.17||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.17|-1.54|0.1164
91485186|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.106|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.106
91485187|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.673|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.673
91669796|NCT00407745|183234231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.447||0.0279|TWO_SIDED|95.0|-1.87|-0.11||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.11|-1.87|0.0279
91669797|NCT00955552|183234232|NON_INFERIORITY|Non-inferiority test of Ártico vs Cosamin DS® regarding the decrease of pain scale (VAS) in the PP population (N = 86).|||||<|0.05||||||For numeric variables Test -t student or ANOVA will be used. It will be considered statistically significant P-value less than 0,05.|t-test, 1 sided|||||||<0.05
91669798|NCT02960438|183234238|SUPERIORITY||Difference of arms|2.2||||0.374|TWO_SIDED|95.0|-19.96|24.46|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||24.46|-19.96|0.374
91669799|NCT02960438|183234238|SUPERIORITY||Difference of arms|11.1||||0.102|TWO_SIDED|95.0|-7.42|29.64|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||29.64|-7.42|0.102
91669800|NCT02960438|183234238|SUPERIORITY||Difference of arms|9.3||||0.188|TWO_SIDED|95.0|-9.25|27.77|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||27.77|-9.25|0.188
91669801|NCT03449199|183234276|SUPERIORITY||LS Mean Difference|-0.05||||0.7953|TWO_SIDED|95.0|-0.44|0.34|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||0.34|-0.44|0.7953
91715031|NCT05556148|183321415|OTHER||Mean Difference (Final Values)|-27.2|||<|0.0001|TWO_SIDED|95.0|-32.48|-21.92|||Student's paired t-test|||Change from Baseline at Day 7||-21.92|-32.48|<.0001
91715032|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.31|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.31|1.0000
91715033|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|-0.63||||0.0003|TWO_SIDED|95.0|-0.97|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-0.97|0.0003
91715034|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Student's paired t-test|||Change from Baseline at Day 3||-0.70|-1.50|<.0001
91715035|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.24|||Student's paired t-test|||Change from Baseline at Day 4||-1.24|-2.20|<.0001
91715036|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.16|||Student's paired t-test|||Change from Baseline at Day 5||-1.16|-2.33|<.0001
91715037|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.28|||Student's paired t-test|||Change from Baseline at Day 6||-1.28|-2.51|<.0001
91715038|NCT05556148|183321416|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.29|-1.64|||Student's paired t-test|||Change from Baseline at Day 7||-1.64|-3.29|<.0001
91715039|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-0.39||||0.0023|TWO_SIDED|95.0|-0.64|-0.14|||Student's paired t-test|||Change from Baseline at Day 1||-0.14|-0.64|0.0023
91715040|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.12|||Student's paired t-test|||Change from Baseline at Day 2||-1.12|-1.82|<.0001
91485188|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
91715041|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-1.99|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.58|||Student's paired t-test|||Change from Baseline at Day 3||-1.58|-2.40|<.0001
91715042|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-2.43|||<|0.0001|TWO_SIDED|95.0|-2.86|-2.0|||Student's paired t-test|||Change from Baseline at Day 4||-2.00|-2.86|<.0001
91715043|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.49|||Student's paired t-test|||Change from Baseline at Day 5||-2.49|-3.51|<.0001
91715044|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-2.77|||<|0.0001|TWO_SIDED|95.0|-3.36|-2.18|||Student's paired t-test|||Change from Baseline at Day 6||-2.18|-3.36|<.0001
91485189|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.065|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.065
91485190|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.567|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.567
91485191|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.135|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.135
91715045|NCT05556148|183321417|OTHER||Mean Difference (Final Values)|-3.33|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.57|||Student's paired t-test|||Change from Baseline at Day 7||-2.57|-4.10|<.0001
91715046|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-0.11||||0.4495|TWO_SIDED|95.0|-0.4|0.18|||Student's paired t-test|||Change from Baseline at Day 1||0.18|-0.40|0.4495
91715047|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.54|||Student's paired t-test|||Change from Baseline at Day 2||-0.54|-1.19|<.0001
91715048|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.82|||Student's paired t-test|||Change from Baseline at Day 3||-0.82|-1.59|<.0001
91715049|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.12|||Student's paired t-test|||Change from Baseline at Day 4||-1.12|-2.05|<.0001
91669802|NCT03449199|183234276|SUPERIORITY||LS Mean Difference|-0.43||||0.0311|TWO_SIDED|95.0|-0.82|-0.04|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||-0.04|-0.82|0.0311
91669803|NCT03449199|183234277|SUPERIORITY||LS Mean Difference|1.71||||0.4055|TWO_SIDED|95.0|-2.35|5.78|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||5.78|-2.35|0.4055
91669804|NCT03449199|183234277|SUPERIORITY||LS Mean Difference|3.42||||0.096|TWO_SIDED|95.0|-0.62|7.46|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||7.46|-0.62|0.0960
91669805|NCT03449199|183234278|SUPERIORITY||LS Mean Difference|-2.43|||<|0.0001|TWO_SIDED|95.0|-3.13|-1.74|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-1.74|-3.13|<0.0001
91669806|NCT03449199|183234278|SUPERIORITY||LS Mean Difference|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.54|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-2.54|-3.91|<0.0001
91669807|NCT03449199|183234279|SUPERIORITY||LS Mean Difference|-102.02||||0.3955|TWO_SIDED|95.0|-338.81|134.78|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||134.78|-338.81|0.3955
91669808|NCT03449199|183234279|SUPERIORITY||LS Mean Difference|-197.49||||0.0991|TWO_SIDED|95.0|-432.73|37.75|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||37.75|-432.73|0.0991
91669809|NCT03449199|183234280|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2791|TWO_SIDED||||||Regression, Logistic||Missing observations at Study Week 12 are imputed as nonresponse.|Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.2791
91669810|NCT03449199|183234280|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0507|TWO_SIDED||||||Regression, Logistic|||Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.0507
91669811|NCT02744755|183234290|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|95.0|-0.24|0.27||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.27|-0.24|
91669812|NCT02744755|183234290|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|90.0|-0.19|0.23||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.23|-0.19|
91669813|NCT02744755|183234291|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.27|-0.11|
91715050|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.33|||Student's paired t-test|||Change from Baseline at Day 5||-1.33|-2.40|<.0001
91715051|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.24|||Student's paired t-test|||Change from Baseline at Day 6||-1.24|-2.45|<.0001
91715052|NCT05556148|183321418|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.19|-1.75|||Student's paired t-test|||Change from Baseline at Day 7||-1.75|-3.19|<.0001
91715053|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|0.11||||0.4758|TWO_SIDED|95.0|-0.2|0.42|||Student's paired t-test|||Change from Baseline at Day 1||0.42|-0.20|0.4758
91715054|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|-0.61||||0.0016|TWO_SIDED|95.0|-0.99|-0.24|||Student's paired t-test|||Change from Baseline at Day 2||-0.24|-0.99|0.0016
91669814|NCT02744755|183234291|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|90.0|-0.08|0.24|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.24|-0.08|
91669815|NCT01652729|183234313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2167||0.001|TWO_SIDED|95.0|-1.15|-0.3|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.30|-1.15|0.0010
91669816|NCT01652729|183234313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1638||0.0209|TWO_SIDED|95.0|-0.7|-0.06|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.06|-0.70|0.0209
91669817|NCT01652729|183234313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2278||0.1347|TWO_SIDED|95.0|-0.79|0.11|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.11|-0.79|0.1347
91669818|NCT01652729|183234314|SUPERIORITY_OR_OTHER|||||||0.0489|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0489
91669819|NCT01652729|183234314|SUPERIORITY_OR_OTHER|||||||0.0103|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0103
91669820|NCT01652729|183234315|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|5.96||0.0924|TWO_SIDED|95.0|-21.8|1.7|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||1.7|-21.8|0.0924
91669821|NCT01652729|183234315|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|8.037||0.0001|TWO_SIDED|95.0|-46.7|-15.1|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-15.1|-46.7|0.0001
91669822|NCT01652729|183234316|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4058||0.8625|TWO_SIDED|95.0|-0.73|0.87||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.87|-0.73|0.8625
91669823|NCT01652729|183234316|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.5419||0.0198|TWO_SIDED|95.0|-2.34|-0.2||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.20|-2.34|0.0198
91669824|NCT01652729|183234317|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.96|STANDARD_ERROR_OF_MEAN|15.71||0.0248|TWO_SIDED|95.0|-67.23|-4.68||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||-4.68|-67.23|0.0248
91715055|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.67|-0.79|||Student's paired t-test|||Change from Baseline at Day 3||-0.79|-1.67|<.0001
91715056|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.18|-1.16|||Student's paired t-test|||Change from Baseline at Day 4||-1.16|-2.18|<.0001
91715057|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.51|||Student's paired t-test|||Change from Baseline at Day 5||-1.51|-2.46|<.0001
91715058|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.77|-1.39|||Student's paired t-test|||Change from Baseline at Day 6||-1.39|-2.77|<.0001
91792714|NCT01293799|183463124|OTHER||Hazard Ratio (HR)|0.88||||0.019|TWO_SIDED|95.0|0.79|0.98||Unit of measure: Serum albumin (Hazard ratio per 5g/L). P-value \< 0.05 is considered significant.|Regression, Cox|Univariable Cox regression||The association of Serum albumin (Hazard ratio per 5 g/L) with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.||0.98|0.79|0.019
91669825|NCT01652729|183234317|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.89|STANDARD_ERROR_OF_MEAN|19.66||0.2914|TWO_SIDED|95.0|-60.02|18.25||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||18.25|-60.02|0.2914
91669826|NCT00483548|183234318|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.36|STANDARD_ERROR_OF_MEAN|1.37||0.7921||95.0|-3.07|2.34||Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.|ANCOVA Mixed-effects repeated-measures|No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.|Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to \[≤\] 0.0076) or futility (nominal 2-sided p-value greater than or equal to \[≥\] 0.5099).||2.34|-3.07|0.7921
91715059|NCT05556148|183321419|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.65|-2.08|||Student's paired t-test|||Change from Baseline at Day 7||-2.08|-3.65|<.0001
91715060|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-0.04||||0.8017|TWO_SIDED|95.0|-0.36|0.28|||Student's paired t-test|||Change from Baseline at Day 1||0.28|-0.36|0.8017
91715061|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-0.67||||0.0005|TWO_SIDED|95.0|-1.05|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-1.05|0.0005
91669827|NCT00483548|183234319|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.7223||95.0|-0.25|0.36|||ANCOVA Mixed-effects repeated-measures|||Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.||0.36|-0.25|0.7223
91669828|NCT00483548|183234320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.846||||0.5029||95.0|0.52|1.38|||Regression, Logistic||Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.38|0.52|0.5029
91669829|NCT00483548|183234321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.949||||0.8266||95.0|0.59|1.52|||Regression, Logistic||Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.52|0.59|0.8266
91669830|NCT00483548|183234322|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.939||||0.7924||95.0|0.59|1.5||Logistic regression model with treatment, country, and type of mood stabilizer.|Regression, Logistic|||Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.50|0.59|0.7924
91669831|NCT00483548|183234323|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.68|STANDARD_ERROR_OF_MEAN|0.89||0.0594||95.0|-3.42|0.07|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-3.42|0.0594
91669832|NCT00483548|183234323|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.25|STANDARD_ERROR_OF_MEAN|1.03||0.223||95.0|-3.27|0.77|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.77|-3.27|0.2230
91669833|NCT00483548|183234323|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|1.09||0.6971||95.0|-2.57|1.72|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.72|-2.57|0.6971
91669834|NCT00483548|183234323|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.68|STANDARD_ERROR_OF_MEAN|1.12||0.5485||95.0|-2.89|1.54|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.54|-2.89|0.5485
91669835|NCT00483548|183234323|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.25|STANDARD_ERROR_OF_MEAN|1.19||0.8322||95.0|-2.6|2.1|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.10|-2.60|0.8322
91669836|NCT00483548|183234324|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1771||95.0|-0.29|0.05|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.29|0.1771
91715062|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.69|-0.89|||Student's paired t-test|||Change from Baseline at Day 3||-0.89|-1.69|<.0001
91715063|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.86|-0.97|||Student's paired t-test|||Change from Baseline at Day 4||-0.97|-1.86|<.0001
91715064|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.47|||Student's paired t-test|||Change from Baseline at Day 5||-1.47|-2.50|<.0001
91715065|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-1.95|||<|0.0001|TWO_SIDED|95.0|-2.61|-1.29|||Student's paired t-test|||Change from Baseline at Day 6||-1.29|-2.61|<.0001
91669837|NCT00483548|183234324|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1765||95.0|-0.37|0.07|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-0.37|0.1765
91669838|NCT00483548|183234324|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6765||95.0|-0.27|0.18|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.27|0.6765
91669839|NCT00483548|183234324|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.977||95.0|-0.24|0.25|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.25|-0.24|0.9770
91715066|NCT05556148|183321420|OTHER||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.54|||Student's paired t-test|||Change from Baseline at Day 7||-1.54|-3.26|<.0001
91715067|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|0.03||||0.8311|TWO_SIDED|95.0|-0.25|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.25|0.8311
91715068|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|-0.41||||0.0313|TWO_SIDED|95.0|-0.78|-0.04|||Student's paired t-test|||Change from Baseline at Day 2||-0.04|-0.78|0.0313
91715069|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|-0.84||||0.0003|TWO_SIDED|95.0|-1.28|-0.39|||Student's paired t-test|||Change from Baseline at Day 3||-0.39|-1.28|0.0003
91715070|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.59|||Student's paired t-test|||Change from Baseline at Day 4||-0.59|-1.51|<.0001
91715071|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.66|||Student's paired t-test|||Change from Baseline at Day 5||-0.66|-1.74|<.0001
91715072|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|-1.05||||0.0018|TWO_SIDED|95.0|-1.69|-0.42|||Student's paired t-test|||Change from Baseline at Day 6||-0.42|-1.69|0.0018
91715073|NCT05556148|183321421|OTHER||Mean Difference (Final Values)|-1.27||||0.0041|TWO_SIDED|95.0|-2.1|-0.43|||Student's paired t-test|||Change from Baseline at Day 7||-0.43|-2.10|0.0041
91715074|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|0.01||||0.938|TWO_SIDED|95.0|-0.25|0.27|||Student's paired t-test|||Change from Baseline at Day 1||0.27|-0.25|0.9380
91669840|NCT00483548|183234324|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7907||95.0|-0.3|0.23|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|-0.30|0.7907
91669841|NCT00483548|183234325|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0392||95.0|-0.43|-0.01|||ANOVA|||Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||-0.01|-0.43|0.0392
91669842|NCT00483548|183234325|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2803||95.0|-0.38|0.11|||ANOVA|||Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.11|-0.38|0.2803
91669843|NCT00483548|183234325|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9835||95.0|-0.26|0.26|||ANOVA|||Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.26|-0.26|0.9835
91669844|NCT00483548|183234325|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7062||95.0|-0.34|0.23|||ANOVA|||Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.23|-0.34|0.7062
91669845|NCT00483548|183234325|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9518||95.0|-0.31|0.29|||ANOVA|||Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.29|-0.31|0.9518
91669846|NCT00483548|183234325|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.4757||95.0|-0.2|0.42||Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|ANOVA|||Week 6; LOCF||0.42|-0.20|0.4757
91669847|NCT00483548|183234326|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.35|STANDARD_ERROR_OF_MEAN|0.75||0.6362||95.0|-1.12|1.82|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.82|-1.12|0.6362
91669848|NCT00483548|183234326|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.59|STANDARD_ERROR_OF_MEAN|0.8||0.4565||95.0|-0.98|2.17|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.17|-0.98|0.4565
91669849|NCT00483548|183234326|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.61|STANDARD_ERROR_OF_MEAN|0.86||0.477||95.0|-1.08|2.3|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.30|-1.08|0.4770
91792715|NCT01293799|183463125|OTHER||Hazard Ratio (HR)|1.41||||0.013|TWO_SIDED|95.0|1.08|1.82||Unit of measure: Serum albumin (\<35 g/L vs. 35 g/L or more). P-value \<0.05 is regarded as significant.|Regression, Cox|Univariable Cox regression||Analysis of the association of serum albumin (\<35 g/L vs. 35 g/l or more) with time to first peritonitis episode by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.||1.82|1.08|0.013
91669850|NCT00483548|183234327|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1277||95.0|-0.2|1.6|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.60|-0.20|0.1277
91792716|NCT01293799|183463125|OTHER||Hazard Ratio (HR)|1.39||||0.015|TWO_SIDED|95.0|1.06|1.82||Unit of measure: Serum albumin (\<35 g/l vs. 35 g/l or more). P-value \<0.05 is regarded as significant.|Regression, Cox|Multivariable Cox regression||Analysis of the association of serum albumin (\<35 g/L vs. 35 g/L or more) with time to first peritonitis episode by multivariable Cox regression.||1.82|1.06|0.015
91715075|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|-0.37||||0.0416|TWO_SIDED|95.0|-0.72|-0.01|||Student's paired t-test|||Change from Baseline at Day 2||-0.01|-0.72|0.0416
91669851|NCT00483548|183234327|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.64|STANDARD_ERROR_OF_MEAN|0.53||0.2345||95.0|-0.41|1.68|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.68|-0.41|0.2345
91669852|NCT00483548|183234327|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.13|STANDARD_ERROR_OF_MEAN|0.6||0.8337||95.0|-1.05|1.3|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.30|-1.05|0.8337
91669853|NCT00483548|183234327|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.43|STANDARD_ERROR_OF_MEAN|0.59||0.4646||95.0|-0.73|1.59|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.59|-0.73|0.4646
91669854|NCT00483548|183234327|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3993||95.0|-0.67|1.67|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.67|-0.67|0.3993
91669855|NCT00483548|183234327|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.19|STANDARD_ERROR_OF_MEAN|0.65||0.7647||95.0|-1.08|1.46|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.46|-1.08|0.7647
91669856|NCT00483548|183234328|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|4.24|STANDARD_ERROR_OF_MEAN|1.65||0.0108||95.0|0.99|7.5|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||7.50|0.99|0.0108
91669857|NCT00483548|183234329|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-4.56|STANDARD_ERROR_OF_MEAN|1.35||0.001||95.0|-7.24|-1.87|||ANCOVA|||Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||-1.87|-7.24|0.0010
91669858|NCT00483548|183234330|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.44|STANDARD_ERROR_OF_MEAN|0.28||0.123|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.12|-1.00|0.1230
91715076|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.62|||Student's paired t-test|||Change from Baseline at Day 3||-0.62|-1.29|<.0001
91669859|NCT00483548|183234330|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.34||0.6232|TWO_SIDED|95.0|-0.84|0.5|||ANCOVA|||Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.50|-0.84|0.6232
91669860|NCT00483548|183234331|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0096||95.0|0.04|0.31|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.31|0.04|0.0096
91669861|NCT00483548|183234331|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.8134||95.0|-0.13|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.13|0.8134
91669862|NCT00483548|183234331|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0226||95.0|0.02|0.29|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.29|0.02|0.0226
91669863|NCT00483548|183234332|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0193||95.0|0.02|0.23|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|0.02|0.0193
91669864|NCT00483548|183234332|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4745||0.16|-0.07|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.07|0.4745
91669865|NCT00483548|183234332|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.2613||95.0|-0.05|0.19|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.19|-0.05|0.2613
91669866|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0271||95.0|0.01|0.21|||ANCOVA|||Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.21|0.01|0.0271
91669867|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7462||95.0|-0.07|0.05|||ANCOVA|||Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.07|0.7462
91669868|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.9574||95.0|-0.08|0.08|||ANCOVA|||Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.08|-0.08|0.9574
91792717|NCT01293799|183463126|OTHER||Hazard Ratio (HR)|0.76||||0.61|TWO_SIDED|95.0|0.27|2.17||Unit of measure: Haemoglobin (HR per 10 g/L). P-value \< 0.05 was considered significant.|Regression, Cox|Univariable Cox regression||The association of Haemoglobin (Hazard ratio per 10 g/L) with time to first peritonitis episode was analysed by univariable Cox regression.||2.17|0.27|0.61
91669869|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0844||95.0|-0.01|0.1|||ANCOVA|||Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.10|-0.01|0.0844
91669870|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.5779||95.0|-0.04|0.06|||ANCOVA|||Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.04|0.5779
91669871|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7455||95.0|-0.05|0.06|||ANCOVA|||Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.05|0.7455
91669872|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3278||95.0|-0.02|0.05|||ANCOVA|||Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.02|0.3278
91669873|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9097||95.0|-0.03|0.03|||ANCOVA|||Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.03|-0.03|0.9097
91669874|NCT00483548|183234333|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9864||95.0|-0.04|0.04|||ANCOVA|||Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.04|-0.04|0.9864
91669875|NCT00483548|183234334|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.52|STANDARD_ERROR_OF_MEAN|2.54||0.5519||95.0|-3.5|6.53|||ANCOVA|||Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||6.53|-3.50|0.5519
91669876|NCT00483548|183234334|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.5238||95.0|-0.35|0.18|||ANCOVA|||Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.35|0.5238
91669877|NCT00483548|183234334|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.09|STANDARD_ERROR_OF_MEAN|0.14||0.536||95.0|-0.19|0.36|||ANCOVA|||Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.36|-0.19|0.5360
91692414|NCT03187301|183279693|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|5.3|14.8||||||60 mins post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||14.8|5.3|
91669878|NCT00112294|183234354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.2358|TWO_SIDED|95.0|0.761|1.069||Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model, with treatment as the single covariate.|Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that \>=510 events (IRRC progressions/deaths) would lead to \>=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.||1.069|0.761|0.2358
91669879|NCT00112294|183234355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.675||||0.0066|TWO_SIDED|95.0|1.152|2.436|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||2.436|1.152|0.0066
91669880|NCT00112294|183234356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.265||||0.1501|TWO_SIDED|95.0|0.918|1.741|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||1.741|0.918|0.1501
91669881|NCT00112294|183234359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1685|TWO_SIDED|95.0|0.754|1.051||An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model with treatment as the single covariate.|Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that \>= 558 events would lead to at \>=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.||1.051|0.754|0.1685
91669882|NCT00112294|183234360|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Cochran-Mantel-Haenszel|||Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||||0.26
91669883|NCT03440424|183234371|OTHER||Percent ratio of geometric mean|157.86|||||TWO_SIDED|90.0|118.18|210.87|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||210.87|118.18|
91669884|NCT03440424|183234371|OTHER||Percent ratio of geometric mean|122.2|||||TWO_SIDED|90.0|91.49|163.24|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||163.24|91.49|
91669885|NCT03440424|183234372|OTHER||Percent ratio of geometric mean|122.31|||||TWO_SIDED|90.0|98.95|151.17|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||151.17|98.95|
91715077|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.76|||Student's paired t-test|||Change from Baseline at Day 4||-0.76|-1.60|<.0001
91715078|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.27|||Student's paired t-test|||Change from Baseline at Day 5||-1.27|-2.25|<.0001
91715079|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.05|||Student's paired t-test|||Change from Baseline at Day 6||-1.05|-2.33|<.0001
91669886|NCT03440424|183234372|OTHER||Percent ratio of geometric mean|103.24|||||TWO_SIDED|90.0|83.53|127.61|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||127.61|83.53|
91669887|NCT03440424|183234373|OTHER||Percent ratio of geometric mean|125.26|||||TWO_SIDED|90.0|96.76|162.16|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||162.16|96.76|
91669888|NCT03440424|183234373|OTHER||Percent ratio of geometric mean|115.2|||||TWO_SIDED|90.0|88.98|149.13|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||149.13|88.98|
91669889|NCT03440424|183234374|OTHER||Percent ratio of geometric mean|131.91|||||TWO_SIDED|90.0|96.46|180.4|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||180.40|96.46|
91669890|NCT03440424|183234374|OTHER||Percent ratio of geometric mean|149.52|||||TWO_SIDED|90.0|109.34|204.47|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||204.47|109.34|
91715080|NCT05556148|183321422|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.08|-1.52|||Student's paired t-test|||Change from Baseline at Day 7||-1.52|-3.08|<.0001
91715081|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|0.04||||0.7821|TWO_SIDED|95.0|-0.25|0.33|||Student's paired t-test|||Change from Baseline at Day 1||0.33|-0.25|0.7821
91715082|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.14|-0.39|||Student's paired t-test|||Change from Baseline at Day 2||-0.39|-1.14|<.0001
91715083|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.19|||Student's paired t-test|||Change from Baseline at Day 3||-1.19|-2.05|<.0001
91715084|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|-2.29|||<|0.0001|TWO_SIDED|95.0|-2.73|-1.86|||Student's paired t-test|||Change from Baseline at Day 4||-1.86|-2.73|<.0001
91715085|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|-2.46|||<|0.0001|TWO_SIDED|95.0|-2.98|-1.94|||Student's paired t-test|||Change from Baseline at Day 5||-1.94|-2.98|<.0001
91715086|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|-2.64|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.92|||Student's paired t-test|||Change from Baseline at Day 6||-1.92|-3.36|<.0001
91715087|NCT05556148|183321423|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.21|||Student's paired t-test|||Change from Baseline at Day 7||-2.21|-4.19|<.0001
91669891|NCT03440424|183234375|OTHER||Percent ratio of geometric mean|125.03|||||TWO_SIDED|90.0|87.96|177.74|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||177.74|87.96|
91669892|NCT03440424|183234375|OTHER||Percent ratio of geometric mean|153.56|||||TWO_SIDED|90.0|106.39|221.66|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||221.66|106.39|
91669893|NCT03440424|183234376|OTHER||Percent ratio of geometric mean|128.88|||||TWO_SIDED|90.0|88.35|188.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||188.02|88.35|
91669894|NCT03440424|183234376|OTHER||Percent ratio of geometric mean|166.55|||||TWO_SIDED|90.0|112.31|246.99|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||246.99|112.31|
91669895|NCT03440424|183234377|OTHER||Percent ratio of geometric mean|96.97|||||TWO_SIDED|90.0|70.15|134.06|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||134.06|70.15|
91669896|NCT03440424|183234377|OTHER||Percent ratio of geometric mean|72.05|||||TWO_SIDED|90.0|52.12|99.6|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||99.60|52.12|
91669897|NCT03440424|183234377|OTHER||Percent ratio of geometric mean|84.36|||||TWO_SIDED|90.0|60.21|118.19|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||118.19|60.21|
91669898|NCT03440424|183234377|OTHER||Percent ratio of geometric mean|65.7|||||TWO_SIDED|90.0|46.89|92.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.05|46.89|
91669899|NCT03440424|183234377|OTHER||Percent ratio of geometric mean|94.74|||||TWO_SIDED|90.0|68.37|131.3|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||131.30|68.37|
91669900|NCT03440424|183234377|OTHER||Percent ratio of geometric mean|76.56|||||TWO_SIDED|90.0|55.24|106.09|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||106.09|55.24|
91669901|NCT03440424|183234379|OTHER||Percent ratio of geometric mean|99.14|||||TWO_SIDED|90.0|76.91|127.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||127.81|76.91|
91669902|NCT03440424|183234379|OTHER||Percent ratio of geometric mean|69.66|||||TWO_SIDED|90.0|54.03|89.79|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||89.79|54.03|
91715088|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|0.44||||0.0003|TWO_SIDED|95.0|0.21|0.68|||Student's paired t-test|||Change from Baseline at Day 1||0.68|0.21|0.0003
91669903|NCT03440424|183234379|OTHER||Percent ratio of geometric mean|78.98|||||TWO_SIDED|90.0|62.88|99.21|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||99.21|62.88|
91669904|NCT03440424|183234379|OTHER||Percent ratio of geometric mean|63.2|||||TWO_SIDED|90.0|50.31|79.38|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||79.38|50.31|
91669905|NCT03440424|183234379|OTHER||Percent ratio of geometric mean|94.56|||||TWO_SIDED|90.0|68.5|130.51|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||130.51|68.50|
91669906|NCT03440424|183234379|OTHER||Percent ratio of geometric mean|71.81|||||TWO_SIDED|90.0|52.03|99.12|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||99.12|52.03|
91669907|NCT03440424|183234380|OTHER||Percent ratio of geometric mean|106.7|||||TWO_SIDED|90.0|83.95|135.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||135.62|83.95|
91669908|NCT03440424|183234380|OTHER||Percent ratio of geometric mean|85.68|||||TWO_SIDED|90.0|67.41|108.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||108.90|67.41|
91669909|NCT03440424|183234380|OTHER||Percent ratio of geometric mean|75.41|||||TWO_SIDED|90.0|62.28|91.31|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||91.31|62.28|
91669910|NCT03440424|183234380|OTHER||Percent ratio of geometric mean|76.0|||||TWO_SIDED|90.0|62.76|92.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.02|62.76|
91715089|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|-0.07||||0.646|TWO_SIDED|95.0|-0.38|0.24|||Student's paired t-test|||Change from Baseline at Day 2||0.24|-0.38|0.6460
91792718|NCT01293799|183463127|OTHER||Hazard Ratio (HR)|0.82||||0.33|TWO_SIDED|95.0|0.54|1.23||"Unit of measure. The time-dependent variable Corticosteroid treatment (yes vs. no). Time-updated data were used. P-value \< 0.05 was considered significant."|Regression, Cox|Time-dependent univariable Cox regression||"The association of the time-dependent variable Corticosteroid treatment (yes vs. no) with time to first peritonitis episode was analysed by time-dependent univariable Cox regression."||1.23|0.54|0.33
91669911|NCT03440424|183234380|OTHER||Percent ratio of geometric mean|95.55|||||TWO_SIDED|90.0|71.92|126.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||126.94|71.92|
91669912|NCT03440424|183234380|OTHER||Percent ratio of geometric mean|74.48|||||TWO_SIDED|90.0|56.06|98.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||98.94|56.06|
91715090|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|-0.59||||0.0021|TWO_SIDED|95.0|-0.95|-0.22|||Student's paired t-test|||Change from Baseline at Day 3||-0.22|-0.95|0.0021
91669913|NCT03440424|183234381|OTHER||Percent ratio of geometric mean|113.04|||||TWO_SIDED|90.0|85.16|150.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||150.05|85.16|
91669914|NCT03440424|183234381|OTHER||Percent ratio of geometric mean|103.74|||||TWO_SIDED|90.0|78.16|137.7|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||137.70|78.16|
91669915|NCT03440424|183234381|OTHER||Percent ratio of geometric mean|78.62|||||TWO_SIDED|90.0|62.57|98.78|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||98.78|62.57|
91669916|NCT03440424|183234381|OTHER||Percent ratio of geometric mean|101.0|||||TWO_SIDED|90.0|80.38|126.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||126.90|80.38|
91669917|NCT03440424|183234381|OTHER||Percent ratio of geometric mean|109.49|||||TWO_SIDED|90.0|81.07|147.88|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||147.88|81.07|
91669918|NCT03440424|183234381|OTHER||Percent ratio of geometric mean|105.2|||||TWO_SIDED|90.0|77.89|142.08|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.08|77.89|
91669919|NCT03440424|183234382|OTHER||Percent ratio of geometric mean|115.38|||||TWO_SIDED|90.0|83.51|159.42|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||159.42|83.51|
91669920|NCT03440424|183234382|OTHER||Percent ratio of geometric mean|116.97|||||TWO_SIDED|90.0|84.66|161.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||161.62|84.66|
91669921|NCT03440424|183234382|OTHER||Percent ratio of geometric mean|78.46|||||TWO_SIDED|90.0|61.06|100.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||100.81|61.06|
91669922|NCT03440424|183234382|OTHER||Percent ratio of geometric mean|116.76|||||TWO_SIDED|90.0|89.95|151.56|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||151.56|89.95|
91715091|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|-0.83||||0.0002|TWO_SIDED|95.0|-1.25|-0.41|||Student's paired t-test|||Change from Baseline at Day 4||-0.41|-1.25|0.0002
91669923|NCT03440424|183234382|OTHER||Percent ratio of geometric mean|94.97|||||TWO_SIDED|90.0|70.31|128.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||128.28|70.31|
91669924|NCT03440424|183234382|OTHER||Percent ratio of geometric mean|103.59|||||TWO_SIDED|90.0|75.43|142.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.28|75.43|
91669925|NCT05070754|183234440|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
91669926|NCT05070754|183234441|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
91669927|NCT05070754|183234442|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
91669928|NCT05070754|183234443|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91669929|NCT05070754|183234444|SUPERIORITY|||||||0.142|||||||Wilcoxon Signed Rank Test|||Null hypothesis: there was no difference in median pain levels between SOC and NTAP treated lesions.||||0.142
91715092|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.73|||Student's paired t-test|||Change from Baseline at Day 5||-0.73|-1.68|<.0001
91715093|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|-1.36||||0.0003|TWO_SIDED|95.0|-2.04|-0.68|||Student's paired t-test|||Change from Baseline at Day 6||-0.68|-2.04|0.0003
91669930|NCT02958319|183234455|SUPERIORITY||Median Difference (Final Values)|4.1||||0.82|TWO_SIDED|||||p \< 0.05 was considered statistically significant|GENERAL LINEAL MODEL|GENERAL LINEAL MODEL OF REPEATED MEASURES||||||0.82
91669931|NCT00372996|183234456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.56|TWO_SIDED|80.0|0.744|1.118|||Log Rank|2-sided p-value from an unstratified log-rank text|Hazard ratio was based on Cox proportional hazards model.|||1.118|0.744|0.560
91669932|NCT00372996|183234457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.331|TWO_SIDED|70.0|0.572|1.02||2-sided p-value from unstratified log-rank test|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||1.020|0.572|0.331
91669933|NCT00372996|183234458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.79||||0.463|TWO_SIDED|95.0|-8.0|17.6|||Pearson chi-square test|||||17.6|-8.0|0.463
91669934|NCT01881737|183234515|SUPERIORITY_OR_OTHER|||||||0.848|||||||Paired t test|||Effect Size Cohen's d = -0.05||||0.848
91669935|NCT01881737|183234516|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t test|Effect Size Cohen's d = 0.53||||||0.009
91669936|NCT01881737|183234517|SUPERIORITY_OR_OTHER|||||||0.38|||||||paired t test|Effect size Cohen's d = 0.38||||||0.38
91669937|NCT01881737|183234519|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91669938|NCT00345033|183234520|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in total cholesterol is over 99%.||||||0.125||95.0|||||ANCOVA|||||||0.125
91669939|NCT00345033|183234521|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in weight will be over 99%.||||||0.109||95.0|||||ANCOVA|||||||0.109
91715094|NCT05556148|183321424|OTHER||Mean Difference (Final Values)|-2.13|||<|0.0001|TWO_SIDED|95.0|-2.95|-1.32|||Student's paired t-test|||Change from Baseline at Day 7||-1.32|-2.95|<.0001
91715095|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|0.2||||0.1074|TWO_SIDED|95.0|-0.04|0.45|||Student's paired t-test|||Change from Baseline at Day 1||0.45|-0.04|0.1074
91792719|NCT01293799|183463128|OTHER||Hazard Ratio (HR)|1.14||||0.6|TWO_SIDED|95.0|0.7|1.84||Unit of measure: Cytotoxic treatment (yes vs. no). Time-updated data was used. P-value \< 0.05 was considered significant.|Regression, Cox|Time-updated univariable Cox regression||"The association of the time-dependent variable Cytotoxic treatment (yes vs. no) with time to first peritonitis episode was analysed by univariable time-dependent Cox regression."||1.84|0.70|0.60
91636582|NCT01468844|183165297|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636583|NCT01468844|183165298|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636584|NCT01468844|183165298|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636585|NCT01468844|183165298|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
91636586|NCT01241318|183165301|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.88|1.44|||||The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.|||1.44|0.88|
91636587|NCT01241318|183165302|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.47|0.86|
91636588|NCT01241318|183165303|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.13|0.47|
91636589|NCT02355665|183165307|SUPERIORITY||Estimated Success Rate Ratio|2.0||||0.021|TWO_SIDED|95.0|1.1|3.66||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.66|1.10|0.021
91636590|NCT02355665|183165308|SUPERIORITY||Estimated Success Rate Ratio|3.04||||0.004|TWO_SIDED|95.0|1.39|6.68||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.68|1.39|0.004
91636591|NCT02355665|183165309|SUPERIORITY||Estimated Success Rate Ratio|2.87||||0.011|TWO_SIDED|95.0|1.23|6.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.71|1.23|0.011
91636592|NCT02355665|183165310|SUPERIORITY||Estimated Success Rate Ratio|1.66||||0.04|TWO_SIDED|95.0|1.02|2.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||2.71|1.02|0.040
91636593|NCT02355665|183165311|SUPERIORITY||Estimated Success Rate Ratio|2.09||||0.023|TWO_SIDED|95.0|1.09|3.98||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.98|1.09|0.023
91636594|NCT02355665|183165312|SUPERIORITY||Estimated Success Rate Ratio|2.91||||0.006|TWO_SIDED|95.0|1.32|6.42||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.42|1.32|0.006
91636595|NCT02355665|183165313|SUPERIORITY||Estimated Success Rate Ratio|2.66||||0.013|TWO_SIDED|95.0|1.2|5.92||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||5.92|1.20|0.013
91669940|NCT00345033|183234522|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Body Mass Index (BMI) will be over 99%.||||||0.229||95.0|||||ANCOVA|||||||0.229
91669941|NCT00345033|183234523|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in glucose metabolism to be 90%.||||||0.01||95.0|||||ANCOVA|||||||0.010
91669942|NCT00345033|183234524|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in triglycerides will be 81%.||||||0.982||95.0|||||ANCOVA|||||||0.982
91669943|NCT00345033|183234525|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Insulin Resistance will be 90%.||||||0.082||95.0|||||ANCOVA|||||||0.082
91669944|NCT03496298|183234526|NON_INFERIORITY|Non-inferiority of efpeglenatide 4 mg+6 mg versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Hazard Ratio (HR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.583|0.918||One-sided p-value based on log rank test of hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|<.0001
91669945|NCT03496298|183234527|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.732||||0.0069|TWO_SIDED|95.0|0.583|0.918||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|0.0069
91669946|NCT03496298|183234528|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.79||||0.02|TWO_SIDED|95.0|0.65|0.96||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.96|0.65|0.02
91669947|NCT03496298|183234529|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.574|0.794||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.794|0.574|<.0001
91669948|NCT01658995|183234530|SUPERIORITY||Risk Difference (RD)|-9.9||||0.37|TWO_SIDED|95.0|-31.4|11.6|||Chi-squared|||||11.6|-31.4|0.37
91669949|NCT01658995|183234531|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
91669950|NCT02058160|183234545|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.633|-0.397||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.||-0.397|-0.633|<0.0001
91669951|NCT02058160|183234546|SUPERIORITY_OR_OTHER||Difference in percentage|25.52|||<|0.0001|TWO_SIDED|95.0|18.94|32.1||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||32.10|18.94|<0.0001
91715096|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|-0.35||||0.0364|TWO_SIDED|95.0|-0.67|-0.02|||Student's paired t-test|||Change from Baseline at Day 2||-0.02|-0.67|0.0364
91792720|NCT01293799|183463129|OTHER||Hazard Ratio (HR)|1.07||||0.72|TWO_SIDED|95.0|0.73|1.57||Unit of measure: Type of PD start (planned vs. acute). P-value \< 0.05 was considered significant.|Regression, Cox|Univariable Cox regression||"The association of Type of PD start with time to first peritonitis episode was analysed by univariable Cox regression."||1.57|0.73|0.72
91792721|NCT01293799|183463130|OTHER||Hazard Ratio (HR)|1.08||||0.77|TWO_SIDED|95.0|0.66|1.76||Unit of measure: Antibiotics prior to PD catheter insertion (yes vs. no). P-value \< 0.05 is considered significant.|Regression, Cox|Univariable Cox regression||"The association of Antibiotics prior to PD catheter insertion (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression."||1.76|0.66|0.77
91792722|NCT01293799|183463131|OTHER||Hazard Ratio (HR)|0.94||||0.68|TWO_SIDED|95.0|0.68|1.28||Unit of measure: Type of PD-catheter (straight vs. coiled). P-value \< 0.05 is considered significant.|Regression, Cox|Univariable Cox regression||"The association of Type of PD catheter used (straight vs. coiled) with time to first peritonitis episode was analysed by univariable Cox regression."||1.28|0.68|0.68
91669952|NCT02058160|183234546|SUPERIORITY_OR_OTHER||Difference in percentage|19.76|||<|0.0001|TWO_SIDED|95.0|13.9|25.62|||Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||25.62|13.90|<0.0001
91715097|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.91|||Student's paired t-test|||Change from Baseline at Day 3||-0.91|-1.68|<.0001
91715098|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.36|||Student's paired t-test|||Change from Baseline at Day 4||-1.36|-2.25|<.0001
91715099|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.69|||Student's paired t-test|||Change from Baseline at Day 5||-1.69|-2.78|<.0001
91669953|NCT02058160|183234547|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-3.925|-2.939||Threshold for significance at 0.05 level.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.||-2.939|-3.925|<0.0001
91669954|NCT02058160|183234548|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-1.808|-0.93||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.||-0.93|-1.808|<0.0001
91669955|NCT02058160|183234549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.154|-0.64||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.||-0.64|-1.154|<0.0001
91669956|NCT02058160|183234550|SUPERIORITY_OR_OTHER||difference in percentage|20.82|||<|0.0001|TWO_SIDED|95.0|14.98|26.66||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening.||26.66|14.98|<0.0001
91669957|NCT02058160|183234551|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.766||0.7362|TWO_SIDED|95.0|-1.762|1.246||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.||1.246|-1.762|0.7362
91669958|NCT03604549|183234643|SUPERIORITY||Risk Ratio (RR)|0.44||||0.1|TWO_SIDED|95.0|0.16|1.25|||Chi-squared||Lipiodol UF is the numerator and Saline is the denominator for RR|||1.25|0.16|0.10
91669959|NCT03604549|183234644|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.96|TWO_SIDED|95.0|-1.59|1.68|||t-test, 2 sided||Difference reported as Lipiodol UF - Saline|||1.68|-1.59|0.96
91669960|NCT03298880|183234682|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.1|5.3|||mixed linear regression|||||5.3|2.1|<0.001
91669961|NCT03298880|183234682|SUPERIORITY||Mean Difference (Net)|2.3||||0.003|TWO_SIDED|95.0|0.8|3.8|||mixed linear regression|||||3.8|0.8|0.003
91715100|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.45|||Student's paired t-test|||Change from Baseline at Day 6||-1.45|-2.70|<.0001
91669962|NCT01488448|183234685|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
91669963|NCT01488448|183234686|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||||||0.77
91669964|NCT01488448|183234687|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Fisher Exact|||||||0.97
91669965|NCT01488448|183234688|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
91669966|NCT01488448|183234689|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.39
91669967|NCT01488448|183234690|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
91715101|NCT05556148|183321425|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.1|||Student's paired t-test|||Change from Baseline at Day 7||-2.10|-3.84|<.0001
91715102|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.43|||Student's paired t-test|||Day 1||-1.43|-2.33|<.0001
91669968|NCT01488448|183234693|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
91669969|NCT01992094|183234694|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1||1.1|0.9|
91715103|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.9|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.90|<.0001
91715104|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.39|||Student's paired t-test|||Day 3||-2.39|-3.41|<.0001
91715105|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.82|-2.77|||Student's paired t-test|||Day 4||-2.77|-3.82|<.0001
91715106|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.37|||Student's paired t-test|||Day 5||-2.37|-3.53|<.0001
91715107|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-3.26|||<|0.0001|TWO_SIDED|95.0|-3.98|-2.53|||Student's paired t-test|||Day 6||-2.53|-3.98|<.0001
91715108|NCT05556148|183321426|OTHER||Mean Difference (Final Values)|-3.12|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.16|||Student's paired t-test|||Day 7||-2.16|-4.08|<.0001
91669970|NCT01992094|183234694|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2||1.1|0.9|
91669971|NCT01992094|183234694|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.8|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.0|0.8|
91669972|NCT01992094|183234694|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.9|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.0|0.9|
91669973|NCT01992094|183234695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-0.5|||||TWO_SIDED|95.0|-5.3|4.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1||4.2|-5.3|
91669974|NCT01992094|183234695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-2.7|||||TWO_SIDED|95.0|-7.2|1.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2||1.9|-7.2|
91669975|NCT01992094|183234695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-1.8|||||TWO_SIDED|95.0|-6.2|2.8|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||2.8|-6.2|
91669976|NCT01992094|183234695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-4.4|||||TWO_SIDED|95.0|-8.9|0.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||0.2|-8.9|
91715109|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.31|||Student's paired t-test|||Day 1||-1.31|-2.14|<.0001
91715110|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-2.12|||<|0.0001|TWO_SIDED|95.0|-2.55|-1.7|||Student's paired t-test|||Day 2||-1.70|-2.55|<.0001
91485192|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.094|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.094
91669977|NCT01992094|183234701|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.6|||||TWO_SIDED|95.0|0.6|0.7||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2||0.7|0.6|
91669978|NCT01992094|183234702|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-19.4|||||TWO_SIDED|95.0|-23.2|-15.5||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2||-15.5|-23.2|
91715111|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.9|||Student's paired t-test|||Day 3||-1.90|-2.71|<.0001
91715112|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.23|-2.29|||Student's paired t-test|||Day 4||-2.29|-3.23|<.0001
91715113|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-2.85|||<|0.0001|TWO_SIDED|95.0|-3.31|-2.39|||Student's paired t-test|||Day 5||-2.39|-3.31|<.0001
91485193|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
91527847|NCT06173570|182930691|SUPERIORITY||Mean Difference (Net)|-28.64|||<|0.001|TWO_SIDED|95.0|-33.8|-23.48|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-23.48|-33.80|< 0.001
91715114|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.64|||Student's paired t-test|||Day 6||-2.64|-3.72|<.0001
91715115|NCT05556148|183321427|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.43|||Student's paired t-test|||Day 7||-2.43|-3.90|<.0001
91715116|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.39|-1.57|||Student's paired t-test|||Day 1||-1.57|-2.39|<.0001
91485194|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.087|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.087
91485195|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.542|TWO_SIDED|95.0|-0.18|0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.18|0.542
91669979|NCT01992094|183234703|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.5|||||TWO_SIDED|95.0|0.5|0.5||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1||0.5|0.5|
91669980|NCT01992094|183234704|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-21.7|||||TWO_SIDED|95.0|-25.5|-17.7||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1||-17.7|-25.5|
91669981|NCT01475487|183234707|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 21 participants per group was required to detect a 40% absolute difference in the complication rate between DP and US guided techniques assuming a 45% complication rate in the DP (control) group and using the Fisher's exact test for the comparison of independent proportions. A total of 23 and 24 participants were recruited in the DP and US group, respectively.|||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||<0.01
91669982|NCT01475487|183234708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.88||||0.001|TWO_SIDED|95.0|1.39|5.94|||Fisher Exact||Risk of injury ( none-mild vs moderate -severe) for all participants|||5.94|1.39|0.001
91669983|NCT01475487|183234708|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Grade 3-4 comparison of None-mild and moderate-severe||||<0.001
91669984|NCT01475487|183234709|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91||||0.701|TWO_SIDED|95.0|0.12|2.72|||Fisher Exact||This is the risk ratio for 1 vs 2 attempts|||2.72|0.12|0.701
91669985|NCT01475487|183234710|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.6||||0.043|TWO_SIDED|95.0|0.79|39.48|||Fisher Exact|||Comparison for Grade 3-4||39.48|0.79|0.043
91669986|NCT03429049|183234749|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.256||0.1904|TWO_SIDED|95.0|-0.84|0.17|||Mixed Models Analysis|||The NRS least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.17|-0.84|0.1904
91669987|NCT03429049|183234750|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.206||0.0257|TWO_SIDED|95.0|-5.07|-0.33|||Mixed Models Analysis|||The WOMAC A least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||-0.33|-5.07|0.0257
91669988|NCT03429049|183234751|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.545||0.0855|TWO_SIDED|95.0|-2.01|0.13|||Mixed Models Analysis|||The WOMAC B least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.13|-2.01|0.0855
91669989|NCT03429049|183234752|SUPERIORITY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.096||0.055|TWO_SIDED|95.0|-15.86|0.26|||Mixed Models Analysis|||The WOMAC C least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.26|-15.86|0.0550
91669990|NCT04412057|183234771|SUPERIORITY||Odds Ratio (OR)|2.86||||0.044|TWO_SIDED|90.0|1.04|7.88|||Regression, Logistic|||The sample size provided greater than 80% power to detect a difference of 0.25 in the proportion of subjects alive and free of respiratory failure using a Chi-square exact test at a one-sided significance level of 0.05. This calculation assumed that the proportion alive and free of respiratory failure will be 0.60 in the placebo group and 0.85 in the CERC-002 group.||7.88|1.04|0.0440
91485196|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.643|TWO_SIDED|95.0|-0.17|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.17|0.643
91669991|NCT04412057|183234772|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1762|TWO_SIDED|90.0|0.59|6.82|||Regression, Logistic|||The proportion of subjects alive at Day 28/ET in the CERC-002 group was compared to that in the placebo group using logistic regression methods. The logistic regression model included terms for treatment group. Model based point estimate (i.e., odds ratio \[OR\]), 90% confidence interval \[CI\], and one-sided p-value were reported.||6.82|0.59|0.1762
91669992|NCT00513617|183234802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1254|STANDARD_ERROR_OF_MEAN|0.0705||0.08||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from the Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.080
91669993|NCT00513617|183234802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.098|STANDARD_ERROR_OF_MEAN|0.0713||0.133||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.133
91715117|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.81|||Student's paired t-test|||Day 2||-1.81|-2.66|<.0001
91715118|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.14|-2.32|||Student's paired t-test|||Day 3||-2.32|-3.14|<.0001
91792723|NCT01293799|183463132|OTHER||Hazard Ratio (HR)|1.26||||0.1|TWO_SIDED|95.0|0.96|1.66||Unit of measure: PD modality (CAPD, continuous ambulatory peritoneal dialysis vs. APD, automated peritoneal dialysis). Time-updated data were used. P-value \< 0.05 is regarded as significant.|Regression, Cox|Univariable time-dependent Cox regression||The PD modality (CAPD or APD) may vary with time and is thus time-dependent. Data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.||1.66|0.96|0.10
91792724|NCT01293799|183463133|OTHER||Hazard Ratio (HR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.17|1.57||Unit of measure: Number of PD bags used/24h. Time-updated data was used. P-value \<0.05 was regarded as significant.|Regression, Cox|Univariable time-dependent Cox regression. (The result of multivariable Cox regression is presented in Statistical analysis 2)||The data regarding the number of PD bags used/24h were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity was found. The risk (hazard ratio) associated with the studied variable is reported.||1.57|1.17|< 0.0001
91669994|NCT00513617|183234804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1826|STANDARD_ERROR_OF_MEAN|0.0713||0.915||||||Alpha was set at 0.5|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.915
91669995|NCT00513617|183234804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3582|STANDARD_ERROR_OF_MEAN|4.1047||0.918||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.918
91669996|NCT00513617|183234805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7867|STANDARD_ERROR_OF_MEAN|1.1101||0.015||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.015
91669997|NCT00513617|183234805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5213|STANDARD_ERROR_OF_MEAN|1.1553||0.557||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.557
91669998|NCT02418455|183234841|SUPERIORITY||LS Mean|-61.0|STANDARD_ERROR_OF_MEAN|6.409|<|0.0001|TWO_SIDED|95.0|-73.56|-48.44||P-values are from generalized estimating equation (GEE) model including baseline value and visit as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||||-48.44|-73.56|< 0.0001
91669999|NCT02418455|183234849|SUPERIORITY|||||||0.2655|||||||t-test|||||||0.2655
91670000|NCT02418455|183234850|SUPERIORITY||LS Mean|-0.99|STANDARD_ERROR_OF_MEAN|0.396||0.0122|TWO_SIDED|95.0|-1.77|-0.22||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||-0.22|-1.77|0.0122
91670001|NCT02418455|183234850|SUPERIORITY||LS Mean|-1.21|STANDARD_ERROR_OF_MEAN|0.461||0.0086|TWO_SIDED|95.0|-2.12|-0.31||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||-0.31|-2.12|0.0086
91670002|NCT02418455|183234850|SUPERIORITY||LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.31||0.0016|TWO_SIDED|95.0|-1.58|-0.37||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 48||-0.37|-1.58|0.0016
91670003|NCT02418455|183234850|SUPERIORITY||LS Mean|-0.57|STANDARD_ERROR_OF_MEAN|0.428||0.1792|TWO_SIDED|95.0|-1.41|0.26||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.26|-1.41|0.1792
91670004|NCT02418455|183234850|SUPERIORITY||LS Mean|-0.35|STANDARD_ERROR_OF_MEAN|0.255||0.1731|TWO_SIDED|95.0|-0.85|0.15||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.15|-0.85|0.1731
91670005|NCT02418455|183234851|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.213||0.0843|TWO_SIDED|95.0|-0.78|0.05||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||0.05|-0.78|0.0843
91670006|NCT02418455|183234851|SUPERIORITY||LS Mean|-0.02|STANDARD_ERROR_OF_MEAN|0.513||0.9618|TWO_SIDED|95.0|-1.03|0.98||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||0.98|-1.03|0.9618
91670007|NCT02418455|183234851|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.391||0.6954|TWO_SIDED|95.0|-0.92|0.61||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|GEE model|||Change at Week 48||0.61|-0.92|0.6954
91670008|NCT02418455|183234851|SUPERIORITY||LS Mean|0.22|STANDARD_ERROR_OF_MEAN|0.364||0.5492|TWO_SIDED|95.0|-0.5|0.93||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.93|-0.50|0.5492
91670009|NCT02418455|183234851|SUPERIORITY||LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.503||0.2618|TWO_SIDED|95.0|-1.55|0.42||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.42|-1.55|0.2618
91670010|NCT02445287|183234852|SUPERIORITY_OR_OTHER|||||||0.92||||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.920
91670011|NCT02445287|183234853|SUPERIORITY_OR_OTHER|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.000
91670012|NCT02445287|183234854|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval = (-0.25, 0.25)||||||0||||||level of significance (alpha) = 0.05|Equivalence test|||||||0.000
91792725|NCT01293799|183463133|OTHER||Hazard Ratio (HR)|1.32|||<|0.0005|TWO_SIDED|95.0|1.13|1.54||Unit of measure: Number of PD bags used /24h. Time-updated data was used. P-value \< 0.05 was regarded as significant.|Regression, Cox|Multivariable time-dependent Cox regression||"Analysis of the association of Number of PD bags used per 24 hours with time to first peritonitis episode by multivariable time-dependent Cox regression. The multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with the studied variable is reported."||1.54|1.13|<0.0005
91670013|NCT02445287|183234855|SUPERIORITY_OR_OTHER|||||||0.012||||||level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.012
91670014|NCT04205162|183234868|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.331
91670015|NCT04205162|183234868|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.122
91670016|NCT04205162|183234869|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.130
91670017|NCT04205162|183234869|OTHER|||||||0.924|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.924
91485197|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.301
91485198|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.237|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.22|0.237
91670018|NCT01546519|183234873|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.95|1.78||||||Cmax Mild HI vs. Normal: Based on pooled variance estimates||1.78|0.95|
91670019|NCT01546519|183234873|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.92|1.83||||||Cmax Moderate HI vs. Normal: Based on pooled variance estimates||1.83|0.92|
91670020|NCT01546519|183234873|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.55|1.37||||||Cmax Severe HI vs. Normal: Based on pooled variance estimates||1.37|0.55|
91670021|NCT01546519|183234873|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.9|1.71||||||Css Mild HI vs. Normal: Based on pooled variance estimates||1.71|0.90|
91670022|NCT01546519|183234873|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.89|1.8||||||Css Moderate HI vs. Normal: Based on pooled variance estimates||1.80|0.89|
91670023|NCT01546519|183234873|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41||||||Css Severe HI vs. Normal: Based on pooled variance estimates||1.41|0.55|
91670024|NCT01546519|183234874|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.89|1.73||||||AUC0-24hr Mild HI vs. Normal: Based on pooled variance estimates||1.73|0.89|
91670025|NCT01546519|183234874|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.91|1.89||||||AUC0-24hr Moderate HI vs. Normal: Based on pooled variance estimates||1.89|0.91|
91670026|NCT01546519|183234874|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.53|1.39||||||AUC0-24hr Severe HI vs. Normal: Based on pooled variance estimates||1.39|0.53|
91670027|NCT00779402|183234882|OTHER||Hazard Ratio (HR)|0.997||||0.65|TWO_SIDED|95.0|0.693|1.433|||Log Rank|Log Rank Test (two sided) stratified by Gleason Score and Radiation Therapy||||1.433|0.693|0.65
91670028|NCT00693225|183234890|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91670029|NCT01186016|183234894|OTHER||||||<|0.01||||||A priori threshold for the P-Value was.05 or less.|ANOVA|||The scores on the Genetic Knowledge Test for both groups between baseline and the end of the educational sessions were analyzed with repeated measures ANOVA.||||<0.01
91670030|NCT01186016|183234895|OTHER|||||||0.44||||||The a priori threshold for statistical significance was a P-Value of .05 or less.|ANOVA|||Data for Self-Efficacy for Quitting/Resisting Smoking were analyzed with repeated measures ANOVA using three time points: baseline, end of the educational sessions, and end of the smoking cessation sessions.||||0.44
91670031|NCT01186016|183234896|OTHER|Nominal data were analyzed with Chi Square.||||||0.88||||||The a priori threshold P-Value for statistical significance was .05 or less.|Chi-squared|||||||.88
91670032|NCT03750695|183234899|OTHER||||||<|0.05|||||||Regression, Linear|||Repeated measures linear regression||||<0.05
91670033|NCT03173560|183234900|NON_INFERIORITY|Odd ratio for ORR24W was analyzed along with 90% CI for each treatment arm using Cochran-Mantel-Haenszel (CMH) method, stratified by Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic group and prior programmed cell death protein 1/ programmed cell death protein ligand 1 (PD-1/PD-L1) treatment from IxRS data. Non-inferiority would be claimed if 1-sided P value is \<=0.045 at the final analysis for the non-inferiority test with the non-inferiority margin of the odd ratio =0.76.|Odds Ratio (OR)|0.88||||0.2676|TWO_SIDED|90.0|0.59|1.32|||Cochran-Mantel-Haenszel|||||1.32|0.59|0.2676
91485199|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
91670034|NCT03173560|183234901|SUPERIORITY|Percentage of participants with intolerable Grade 2 or any Grade \>=Grade 3 TEAEs within 24 weeks was tested using CMH method at 2-sided α=0.05, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment from IxRS data. The treatment difference and 95% CI were also calculated based on asymptotic normal approximation.|Difference|3.2||||0.4763|TWO_SIDED|95.0|-5.5|11.9|||Cochran-Mantel-Haenszel|||||11.9|-5.5|0.4763
91670035|NCT03173560|183234902|OTHER|The hazard ratio and the corresponding 90% CIs were estimated using the Cox regression model with Efron's method for ties, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|90.0|1.08|1.86||||||||1.86|1.08|
91670036|NCT03173560|183234903|OTHER|Odd ratio for ORR was analyzed along with 90% CI for each treatment arm using CMH method stratified by MSKCC prognostic group and PD-1/PD-L1 treatment from IxRS data.|Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.52|1.14||||||||1.14|0.52|
91670037|NCT02174276|183234918|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.017||||0.805|TWO_SIDED|95.0|-0.155|0.12|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.120|-0.155|0.805
91670038|NCT02174276|183234918|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|0.063||||0.37|TWO_SIDED|95.0|-0.075|0.202|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.202|-0.075|0.370
91670039|NCT02174276|183234918|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.056||||0.426|TWO_SIDED|95.0|-0.194|0.082|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.082|-0.194|0.426
91670040|NCT00216060|183234937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.08||||0.3|TWO_SIDED|95.0|0.51|8.4|||Regression, Cox|||||8.40|0.51|0.3
91670041|NCT00216060|183234938|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||univariate analysis|||||||0.12
91670042|NCT00216060|183234940|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91670043|NCT00216060|183234942|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91670044|NCT00216060|183234943|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.010
91670045|NCT00216060|183234944|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91670046|NCT04480307|183234972|SUPERIORITY||LS Mean Difference|-0.031||||0.5084|TWO_SIDED|95.0|-0.124|0.063|||ANCOVA|||||0.063|-0.124|0.5084
91670047|NCT04480307|183234972|SUPERIORITY||Difference of change from Baseline|-0.021|||||TWO_SIDED|95.0|-0.121|0.057|||Bayesian|Difference of change from baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.057|-0.121|
91670048|NCT04480307|183234973|SUPERIORITY||LS Mean Difference|-0.002||||0.9472|TWO_SIDED|95.0|-0.052|0.049|||ANCOVA|||||0.049|-0.052|0.9472
91670049|NCT04480307|183234973|SUPERIORITY||Difference of change from Baseline|0.012|||||TWO_SIDED|95.0|-0.036|0.059|||Bayesian|Difference of change from Baseline a posteriori.||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.059|-0.036|
91670050|NCT04480307|183234974|SUPERIORITY||LS Mean Difference|0.154||||0.4027|TWO_SIDED|95.0|-0.216|0.524|||ANCOVA|||ANCOVA analysis for T1 lesion volume parameter||0.524|-0.216|0.4027
91670051|NCT04480307|183234974|SUPERIORITY||LS Mean Difference|0.01||||0.7428|TWO_SIDED|95.0|-0.051|0.071|||ANCOVA|||ANCOVA analysis for T2 lesion volume parameter||0.071|-0.051|0.7428
91670052|NCT04480307|183234975|SUPERIORITY||LS Mean Difference|0.003||||0.7314|TWO_SIDED|95.0|-0.013|0.018|||ANCOVA|||||0.018|-0.013|0.7314
91670053|NCT04480307|183234975|SUPERIORITY||Difference of change from Baseline|0.005|||||TWO_SIDED|95.0|-0.01|0.023|||Bayesian|Difference of change from Baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.023|-0.010|
91670054|NCT04480307|183234976|SUPERIORITY||LS Mean Difference|0.0||||0.7662|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||||0|0|0.7662
91670055|NCT01589601|183234978|SUPERIORITY||Mean Difference (Net)|4.8719||||0.1641|TWO_SIDED|95.0|-2.0289|11.7728|||Mixed Models Analysis|Baseline||||11.7728|-2.0289|0.1641
91670056|NCT01589601|183234978|SUPERIORITY|6 Months|Mean Difference (Net)|9.4938||||0.0299|TWO_SIDED|95.0|0.9406|18.047|||Mixed Models Analysis|||||18.0470|0.9406|0.0299
91670057|NCT01589601|183234979|SUPERIORITY||Mean Difference (Net)|2.7157||||0.5531|TWO_SIDED|95.0|-6.3054|11.7368|||Mixed Models Analysis|Baseline||||11.7368|-6.3054|0.5531
91670058|NCT01589601|183234979|SUPERIORITY||Mean Difference (Net)|11.773||||0.035|TWO_SIDED|95.0|0.8409|22.7052|||Mixed Models Analysis|6 Months||||22.7052|0.8409|0.0350
91670059|NCT01589601|183234980|SUPERIORITY|HADS Anxiety 2 weeks|Mean Difference (Net)|-1.2436||||0.1592|TWO_SIDED|95.0|-2.9817|0.4945|||Mixed Models Analysis|||||0.4945|-2.9817|0.1592
91670060|NCT01589601|183234980|SUPERIORITY|HADS Anxiety 3 months|Mean Difference (Net)|-0.7946||||0.3657|TWO_SIDED|95.0|-2.5285|0.9393|||Mixed Models Analysis|||||0.9393|-2.5285|0.3657
91670061|NCT01589601|183234980|SUPERIORITY|HADS Anxiety 6 months|Mean Difference (Net)|-1.8269||||0.048|TWO_SIDED|95.0|-3.6375|-0.0164|||Mixed Models Analysis|||||-0.0164|-3.6375|0.0480
91670062|NCT01589601|183234980|SUPERIORITY|HADS Depression at 2 weeks|Mean Difference (Net)|-0.9097||||0.2372|TWO_SIDED|95.0|-2.4253|0.6058|||Mixed Models Analysis|||||0.6058|-2.4253|0.2372
91792726|NCT01293799|183463134|OTHER||Hazard Ratio (HR)|1.03||||0.13|TWO_SIDED|95.0|0.99|1.08||Unit of measure: Volume of dialysis fluid/24h (L). Time-updated data was used. P-value \< 0.05 was considered significant.|Regression, Cox|Univariable time-dependent Cox regression||"Data regarding Volume of dialysis fluid used/24h was included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity was found. The risk (hazard ratio) associated with the studied variable is reported."||1.08|0.99|0.13
91525978|NCT03502616|182927258|SUPERIORITY||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.638||0.1289|TWO_SIDED|95.0|-0.28|2.23|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.23|-0.28|0.1289
91636596|NCT02355665|183165314|SUPERIORITY||Estimated Mean Difference|-0.02||||0.847|TWO_SIDED|95.0|-0.64|0.6||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.60|-0.64|0.847
91636597|NCT02355665|183165315|SUPERIORITY||Estimated Mean Difference|-0.1||||0.861|TWO_SIDED|95.0|-0.62|0.42||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.42|-0.62|0.861
91636598|NCT02355665|183165316|SUPERIORITY||Estimated Mean Difference|-0.19||||0.266|TWO_SIDED|95.0|-0.61|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.24|-0.61|0.266
91636599|NCT02355665|183165317|SUPERIORITY||Estimated Mean Difference|0.09||||0.487|TWO_SIDED|95.0|-0.38|0.55||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.55|-0.38|0.487
91636600|NCT02355665|183165318|SUPERIORITY||Estimated Mean Difference|-0.11||||0.433|TWO_SIDED|95.0|-0.65|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.43|-0.65|0.433
91636601|NCT02355665|183165319|SUPERIORITY||Estimated Mean Difference|-0.58||||0.022|TWO_SIDED|95.0|-1.15|-0.01||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||-0.01|-1.15|0.022
91636602|NCT02355665|183165320|SUPERIORITY||Estimated Mean Difference|0.0||||0.665|TWO_SIDED|95.0|-0.5|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.49|-0.50|0.665
91636603|NCT02355665|183165321|SUPERIORITY||Estimated Mean Difference|-0.1||||0.3|TWO_SIDED|95.0|-0.51|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.31|-0.51|0.300
91636604|NCT02355665|183165322|SUPERIORITY||Estimated Mean Difference|-0.17||||0.754|TWO_SIDED|95.0|-0.78|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.43|-0.78|0.754
91636605|NCT02355665|183165323|SUPERIORITY||Estimated Mean Difference|-0.41||||0.116|TWO_SIDED|95.0|-0.89|0.08||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.08|-0.89|0.116
91670063|NCT01589601|183234980|SUPERIORITY|HADS Depression 3 months|Mean Difference (Net)|-0.6592||||0.4237|TWO_SIDED|95.0|-2.2862|0.9678|||Mixed Models Analysis|||||0.9678|-2.2862|0.4237
91636606|NCT02355665|183165324|SUPERIORITY||Estimated Mean Difference|-0.14||||0.392|TWO_SIDED|95.0|-0.47|0.2||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.20|-0.47|0.392
91636607|NCT02355665|183165325|SUPERIORITY||Estimated Mean Difference|-0.23||||0.179|TWO_SIDED|95.0|-0.59|0.13||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.13|-0.59|0.179
91670064|NCT01589601|183234980|SUPERIORITY|HADS Depression at 6 months|Mean Difference (Net)|-1.9379||||0.0202|TWO_SIDED|95.0|-3.5672|-0.3085|||Mixed Models Analysis|||||-0.3085|-3.5672|0.0202
91670065|NCT01589601|183234982|SUPERIORITY|FACIT-Sp at 2 weeks|Mean Difference (Net)|0.9413||||0.5857|TWO_SIDED|95.0|-2.4666|4.3493|||Mixed Models Analysis|||||4.3493|-2.4666|0.5857
91525979|NCT03502616|182927258|SUPERIORITY||LS mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.616||0.4698|TWO_SIDED|95.0|-0.77|1.66|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.66|-0.77|0.4698
91636608|NCT02355665|183165326|SUPERIORITY||Estimated Mean Difference|0.01||||0.925|TWO_SIDED|95.0|-0.44|0.47||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.47|-0.44|0.925
91636609|NCT02355665|183165327|SUPERIORITY||Estimated Mean Difference|-0.21||||0.325|TWO_SIDED|95.0|-0.66|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.24|-0.66|0.325
91636610|NCT02355665|183165328|SUPERIORITY||Estimated Mean Difference|0.13||||0.891|TWO_SIDED|95.0|-0.24|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.51|-0.24|0.891
91636611|NCT02355665|183165329|SUPERIORITY||Estimated Mean Difference|-0.11||||0.721|TWO_SIDED|95.0|-0.48|0.25||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.25|-0.48|0.721
91636612|NCT02355665|183165330|SUPERIORITY||Estimated Mean Difference|-0.03||||0.608|TWO_SIDED|95.0|-0.54|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.49|-0.54|0.608
91636613|NCT02355665|183165331|SUPERIORITY||Estimated Mean Difference|-0.63||||0.014|TWO_SIDED|95.0|-1.16|-0.09||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||-0.09|-1.16|0.014
91636614|NCT02355665|183165332|SUPERIORITY||Estimated Mean Difference|0.04||||0.9|TWO_SIDED|95.0|-0.3|0.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.38|-0.30|0.900
91636615|NCT02355665|183165333|SUPERIORITY||Estimated Mean Difference|-0.06||||0.731|TWO_SIDED|95.0|-0.44|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.31|-0.44|0.731
91636616|NCT02355665|183165334|SUPERIORITY||Estimated Mean Difference|0.04||||0.635|TWO_SIDED|95.0|-0.28|0.36||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.36|-0.28|0.635
91636617|NCT02355665|183165335|SUPERIORITY||Estimated Mean Difference|-0.05||||0.273|TWO_SIDED|95.0|-0.42|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.42|0.273
91636618|NCT02355665|183165336|SUPERIORITY||Estimated Mean Difference|-0.06||||0.879|TWO_SIDED|95.0|-0.4|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.28|-0.40|0.879
91636619|NCT02355665|183165337|SUPERIORITY||Estimated Mean Difference|0.02||||0.823|TWO_SIDED|95.0|-0.28|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.28|0.823
91636620|NCT02355665|183165338|SUPERIORITY||Estimated Mean Difference|0.0||||0.804|TWO_SIDED|95.0|-0.4|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.40|-0.40|0.804
91636621|NCT02355665|183165339|SUPERIORITY||Estimated Mean Difference|0.13||||0.438|TWO_SIDED|95.0|-0.3|0.57||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.57|-0.30|0.438
91636622|NCT02355665|183165340|SUPERIORITY||Estimated Mean Difference|-0.08||||0.517|TWO_SIDED|95.0|-0.44|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.28|-0.44|0.517
91485200|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.854|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.854
91485201|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
91485202|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
91485203|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
91485204|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
91485205|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
91485206|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
91485207|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.016|TWO_SIDED|95.0|-0.27|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.27|0.016
91485208|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.38|<0.001
91485209|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.44|-0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.19|-0.44|<0.001
91485210|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.39|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.39|<0.001
91485211|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.037|TWO_SIDED|95.0|-0.27|-0.01|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.27|0.037
91636623|NCT02355665|183165341|SUPERIORITY||Estimated Mean Difference|-0.42||||0.027|TWO_SIDED|95.0|-0.77|-0.06||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||-0.06|-0.77|0.027
91485212|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.015
91485213|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||0.07|-0.22||||0.001|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.001
91636624|NCT02355665|183165342|SUPERIORITY||Estimated Mean Difference|-0.3||||0.105|TWO_SIDED|95.0|-0.93|0.33||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.33|-0.93|0.105
91636625|NCT02355665|183165343|SUPERIORITY||Estimated Mean Difference|-0.04||||0.604|TWO_SIDED|95.0|-0.6|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.51|-0.60|0.604
91485214|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
91485215|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.042|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.042
91485216|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.14|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.40|<0.001
91485217|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
91485218|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.50|<0.001
91485219|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.182|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.22|0.182
91636626|NCT02355665|183165344|SUPERIORITY||Estimated Mean Difference|-0.35||||0.194|TWO_SIDED|95.0|-0.93|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.24|-0.93|0.194
91636627|NCT02355665|183165345|SUPERIORITY||Estimated Mean Difference|-0.11||||0.502|TWO_SIDED|95.0|-0.62|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.40|-0.62|0.502
91636628|NCT02355665|183165346|SUPERIORITY||Estimated Mean Difference|-0.56||||0.483|TWO_SIDED|95.0|-2.84|1.73||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.73|-2.84|0.483
91636629|NCT02355665|183165347|SUPERIORITY||Estimated Mean Difference|-1.79||||0.102|TWO_SIDED|95.0|-4.24|0.67||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.67|-4.24|0.102
91636630|NCT02355665|183165348|SUPERIORITY||Estimated Mean Difference|-0.45||||0.532|TWO_SIDED|95.0|-2.27|1.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.38|-2.27|0.532
91636631|NCT02355665|183165349|SUPERIORITY||Estimated Mean Difference|-1.01||||0.354|TWO_SIDED|95.0|-2.93|0.91||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.91|-2.93|0.354
91636632|NCT02355665|183165518|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|1.679||0.558|TWO_SIDED|95.0|-2.42|4.41||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||4.41|-2.42|0.558
91636633|NCT02355665|183165519|SUPERIORITY||Least Squares Mean Difference|3.04|STANDARD_ERROR_OF_MEAN|3.409||0.383|TWO_SIDED|95.0|-4.03|10.11||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||10.11|-4.03|0.383
91636634|NCT02355665|183165520|SUPERIORITY||Least Squares Mean Difference|7.13|STANDARD_ERROR_OF_MEAN|4.573||0.138|TWO_SIDED|95.0|-2.56|16.83||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||16.83|-2.56|0.138
91636635|NCT02380703|183165551|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.29|TWO_SIDED|95.0|0.78|2.32||For participants who dropped out, their time until study attrition was used as the exposure period; and they were carried forward as part of the overall incidence count.|Regression, Cox|||Sample-size calculations were performed, based on the ability to detect a small-to-moderate difference (Cohen's h = 0.4) in rate of aggression onset over a 1-year period between APT and EU-PC, assuming 80% power and a type I error rate of 5%. Given an anticipated rate of aggression onset over 1 year of 37% for EU-PC, an ES of h = 0.4 allows detection of aggression onset in APT as high as 19%. Given this effect size and up to 10% attrition, our goal was to include 220 total participants.||2.32|0.78|0.29
91636636|NCT02380703|183165551|EQUIVALENCE|Examination of whether the presence of aggression is equivalent between APT and EU-PC|Difference in frequencies|1.21||||0.27|TWO_SIDED|||||Association between presence of aggression and condition (APT vs EU-PC).|Chi-squared|X2(1) = 1.21||||||0.27
91636637|NCT02380703|183165552|SUPERIORITY||F-statistic|1.59||||0.19|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.19
91670066|NCT01589601|183234982|SUPERIORITY|FACIT-Sp at 3 months|Mean Difference (Net)|1.1174||||0.5655|TWO_SIDED|95.0|-2.7246|4.9594|||Mixed Models Analysis|||||4.9594|-2.7246|0.5655
91670067|NCT01589601|183234982|SUPERIORITY|FACIT-Sp at 6 months|Mean Difference (Net)|3.9809||||0.0271|TWO_SIDED|95.0|0.4581|7.5036|||Mixed Models Analysis|||||7.5036|0.4581|0.0271
91670068|NCT01589601|183234984|SUPERIORITY|All-cause readmissions, Poisson regression with log link and Pearson scale||||||0.56|||||||Poisson regression|||||||0.56
91670069|NCT01589601|183234984|SUPERIORITY|Cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.8|||||||Poisson regression|||||||0.80
91670070|NCT01589601|183234984|SUPERIORITY|Heart failure readmissions, Poisson regression with log link and Pearson scale||||||0.92|||||||Poisson regression|||||||0.92
91670071|NCT01589601|183234984|SUPERIORITY|Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.12|||||||Poisson regression|||||||0.12
91670072|NCT00434837|183234985|SUPERIORITY|||||||0.27|||||||ANOVA|||These results are from the 3-year analysis.||||.27
91670073|NCT00434837|183234986|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 7-year analysis.||||.08
91792727|NCT01293799|183463135|OTHER||Hazard Ratio (HR)|1.04||||0.79|TWO_SIDED|95.0|0.77|1.41||Unit of measure: Help needed with exit-site care (yes vs. no). Time-updated data was used. P-value \< 0.05 was considered significant.|Regression, Cox|Univariable time-dependent Cox regression||"Data regarding the variable Help needed with exit-site care (yes vs. no) were included as time-varying covariates in a univariable time-dependent Cox regression in order to identify variables significantly associated with time to first peritonitis episode. The risk (hazard ratio) associated with the studied variable is reported.."||1.41|0.77|0.79
91792728|NCT01293799|183463136|OTHER||Hazard Ratio (HR)|0.92||||0.52|TWO_SIDED|95.0|0.71|1.19||Unit of measure: Study group (retraining group vs. control group). P-value \<0.05 is regarded as significant.|Regression, Cox|||Association ot the Retraining group vs. the Control group with time to first peritonitis episode by univariable Cox regression||1.19|0.71|0.52
91792729|NCT03044574|183463151|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91792730|NCT03044574|183463152|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
91792731|NCT03044574|183463153|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91485220|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.08|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.080
91670074|NCT00434837|183234987|SUPERIORITY|||||||0.22|||||||ANOVA|||These results are from the 15-year analysis.||||.22
91670075|NCT00434837|183234988|SUPERIORITY|||||||0.0078|||||||ANOVA|||These results are from the 15-year analysis.||||.0078
91715119|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-2.91|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.43|||Student's paired t-test|||Day 4||-2.43|-3.40|<.0001
91485221|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
91485222|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.37|<0.001
91670076|NCT00434837|183234989|SUPERIORITY|||||||0.0018|||||||ANOVA|||These results are from the 15-year analysis.||||.0018
91485223|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.016|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.016
91670077|NCT00434837|183234990|SUPERIORITY|||||||0.015|||||||ANOVA|||These results are from the 15-year analysis.||||.015
91715120|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.68|-2.66|||Student's paired t-test|||Day 5||-2.66|-3.68|<.0001
91670078|NCT00434837|183234991|SUPERIORITY|||||||0.003|||||||ANOVA|||These results are from the 15-year analysis.||||.003
91670079|NCT00434837|183234992|SUPERIORITY|||||||0.0006|||||||ANOVA|||These results are from the 15-year analysis.||||.0006
91670080|NCT00434837|183234993|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
91670081|NCT00434837|183234994|SUPERIORITY|||||||0.34|||||||Chi-squared|||These results are from the 15-year analysis.||||.34
91670082|NCT00434837|183234995|SUPERIORITY|||||||0.17|||||||ANOVA|||These results are from the 15-year analysis.||||.17
91670083|NCT00434837|183234996|SUPERIORITY|||||||0.25|||||||ANOVA|||These results are from the 15-year analysis.||||.25
91715121|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-3.28|||<|0.0001|TWO_SIDED|95.0|-4.02|-2.54|||Student's paired t-test|||Day 6||-2.54|-4.02|<.0001
91715122|NCT05556148|183321428|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.24|-2.7|||Student's paired t-test|||Day 7||-2.70|-4.24|<.0001
91792732|NCT03044574|183463154|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
91792733|NCT03044574|183463155|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91792734|NCT03044574|183463156|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91792735|NCT03044574|183463157|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91792736|NCT03044574|183463159|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91792737|NCT02635646|183463164|OTHER|T test for mean comparisons between independent groups||||||0.844||||||Significant p value less than 0.05|t-test, 2 sided|||||||0.844
91792738|NCT02635646|183463165|OTHER|||||||0.624|||||||t-test, 2 sided|||||||0.624
91792739|NCT02635646|183463166|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91792740|NCT02635646|183463167|OTHER|||||||0.516|||||||t-test, 2 sided|||||||0.516
91792741|NCT02635646|183463168|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91792742|NCT02387476|183463171|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.13|<|0.001|TWO_SIDED|95.0|-1.7|2.9||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean AHI is rounded to a single decimal point in the text of the report (3.0 and 2.4, respectively), in order to be consistent with standard reporting of AHI.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||2.9|-1.7|<0.001
91636638|NCT02380703|183165553|SUPERIORITY||F-statistic|2.43||||0.06|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.06
91636639|NCT02380703|183165554|SUPERIORITY||F-statistic|0.33||||0.8|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.80
91636640|NCT02380703|183165555|SUPERIORITY||F-statistic|0.21||||0.89|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.89
91636641|NCT02380703|183165556|SUPERIORITY||F-statistic|1.48||||0.22|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.22
91636642|NCT02380703|183165557|SUPERIORITY||F-statistic|0.38||||0.77|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.77
91636643|NCT02380703|183165558|SUPERIORITY||F-statistic|0.56||||0.64|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.64
91636644|NCT01408862|183165583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by Wilcoxon-paired test. Variable will be log-transformed if they were not normally distributed. . We used the CSS/ Statistica program package, StatSoft V 6.0.~This analysis applies to both GLP1R and GIPR categories"||||0.04
91636645|NCT01408862|183165584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.2|||||||ANOVA|||Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by two-way ANOVA with repeated measures on one factor, for variables measured in several consecutive times. Variable will be log-transformed if they were not normally distributed. Wilcoxon test for paired samples was used. The Statistica program package (StatSoft V 6.0) were used to perform these analyses, which applied to both GLP1R and GIPR agonist effect categories.||||0.20
91636646|NCT01813149|183165593|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|df=20 t-statistic = 2.90||A t-test to see if expression of α1-AR differs between phenylephrine responders and non-responders||||0.009
91636647|NCT01882439|183165599|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.95|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|14.72|37.19|||Large sample approximation|Missing response (MR) = non-response (NR)||||37.19|14.72|<0.0001
91636648|NCT01882439|183165599|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.31|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|12.1|34.51|||Large sample approximation|MR=NR||||34.51|12.10|<0.0001
91636649|NCT01882439|183165600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2529|STANDARD_ERROR_OF_MEAN|0.06422|<|0.0001|TWO_SIDED|95.0|-0.3792|-0.1266|||Mixed Models Analysis|No imputation||||-0.1266|-0.3792|<0.0001
91636650|NCT01882439|183165600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.06453||0.0009|TWO_SIDED|95.0|-0.3419|-0.0881|||Mixed Models Analysis|No imputation||||-0.0881|-0.3419|0.0009
91670084|NCT00434837|183234997|SUPERIORITY|||||||0.61|||||||ANOVA|||These results are from the 15-year analysis.||||.61
91636651|NCT03125902|183165639|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2032|TWO_SIDED|95.0|0.6|1.12|||Log Rank|||Stratified Analysis||1.12|0.60|0.2032
91636652|NCT03125902|183165639|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2601|TWO_SIDED|95.0|0.62|1.14|||Log Rank|||Unstratified Analysis||1.14|0.62|0.2601
91636653|NCT03125902|183165640|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.86||||0.1343|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||||1.05|0.70|0.1343
91636654|NCT03125902|183165640|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1285|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||Unstratified Analysis||1.05|0.70|0.1285
91636655|NCT03125902|183165641|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5798|TWO_SIDED|95.0|0.76|1.64|||Log Rank|||Stratified Analysis||1.64|0.76|0.5798
91636656|NCT03125902|183165641|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4035|TWO_SIDED|95.0|0.8|1.72|||Log Rank|||Unstratified Analysis||1.72|0.80|0.4035
91670085|NCT00434837|183234998|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
91670086|NCT00434837|183234999|SUPERIORITY|||||||0.53|||||||ANOVA|||These results are from the 15-year analysis.||||.53
91670087|NCT00434837|183235000|SUPERIORITY|||||||0.82|||||||ANOVA|||These results are from the 15-year analysis.||||.82
91670088|NCT00434837|183235001|SUPERIORITY|||||||0.03|||||||ANOVA|||These results are from the 15-year analysis.||||.03
91670089|NCT00434837|183235002|SUPERIORITY|||||||0.67|||||||ANOVA|||These results are from the 15-year analysis.||||.67
91670090|NCT00434837|183235004|SUPERIORITY|||||||0.051|||||||ANOVA|||These results are from the 15-year analysis.||||.051
91670091|NCT00434837|183235005|SUPERIORITY|||||||0.14|||||||ANOVA|||These results were from the 15-year analysis.||||.14
91670092|NCT00434837|183235006|SUPERIORITY|||||||0.067|||||||ANOVA|||These results are from the 15-year analysis.||||.067
91670093|NCT00434837|183235007|SUPERIORITY|||||||0.54|||||||ANOVA|||These results were from the 7-year analysis.||||.54
91670094|NCT00434837|183235008|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 15-year analysis.||||.08
91670095|NCT02102932|183235032|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.29|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|101.92|108.78||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.78|101.92|0.0000
91670096|NCT02102932|183235032|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.23|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.91|106.65||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.65|99.91|0.0000
91636657|NCT03125902|183165642|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.3425|TWO_SIDED|95.0|0.88|1.43|||Log Rank|||Stratified analysis||1.43|0.88|0.3425
91636658|NCT03125902|183165642|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2166|TWO_SIDED|95.0|0.92|1.48|||Log Rank|||Unstratified Analysis||1.48|0.92|0.2166
91636659|NCT03125902|183165644|OTHER|Stratified analysis|Hazard Ratio (HR)|0.94||||0.6465|TWO_SIDED|95.0|0.71|1.24|||Log Rank|||||1.24|0.71|0.6465
91636660|NCT03125902|183165646|OTHER||Odds Ratio (OR)|1.44||||0.1526|TWO_SIDED|95.0|0.87|2.37|||Cochran-Mantel-Haenszel|||||2.37|0.87|0.1526
91636661|NCT03125902|183165647|OTHER||Odds Ratio (OR)|1.4||||0.1834|TWO_SIDED|95.0|0.85|2.31|||Cochran-Mantel-Haenszel|||||2.31|0.85|0.1834
91636662|NCT03125902|183165648|OTHER||Odds Ratio (OR)|1.42||||0.0513|TWO_SIDED|95.0|1.0|2.02|||Cochran-Mantel-Haenszel|||||2.02|1.00|0.0513
91636663|NCT03125902|183165649|OTHER||Odds Ratio (OR)|1.3||||0.1226|TWO_SIDED|95.0|0.93|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.93|0.1226
91670097|NCT02102932|183235032|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.56|STANDARD_DEVIATION|7.6||0|TWO_SIDED|90.0|99.73|107.54||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.54|99.73|0.0000
91670098|NCT02102932|183235032|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.81|STANDARD_DEVIATION|6.9||0|TWO_SIDED|90.0|99.36|106.37||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.37|99.36|0.0000
91636664|NCT03125902|183165650|OTHER|Unstratified Analysis|Hazard Ratio (HR)|0.74||||0.0641|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|0.0641
91636665|NCT03125902|183165660|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.01227|TWO_SIDED|95.0|0.42|0.9|||Log Rank|||Unstratified Analysis||0.90|0.42|0.01227
91636666|NCT01997333|183165661|SUPERIORITY|||||||0.761|||||||Log Rank|Stratified log rank test.||||||0.761
91636667|NCT01997333|183165662|SUPERIORITY|||||||0.264|||||||Cochran-Mantel-Haenszel|Adjusted for stratification factors.||||||0.264
91636668|NCT01997333|183165664|SUPERIORITY|||||||0.726|||||||Log Rank|Stratified log rank.||||||0.726
91636669|NCT02269709|183165667|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline and Follow-up #1||||<0.0001
91636670|NCT02269709|183165667|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow up #2||||<0.0001
91636671|NCT02269709|183165667|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow-up #3||||<0.0001
91636672|NCT02269709|183165668|OTHER|Mean IVC pressures from different time points were compared using the Wilcoxon signed-rank test.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91636673|NCT00890396|183165669|SUPERIORITY|||||||0.67|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.67
91636674|NCT00890396|183165670|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||>0.99
91636675|NCT00890396|183165671|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.61
91636676|NCT00890396|183165672|SUPERIORITY|||||||0.78|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.78
91636677|NCT00890396|183165673|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.80
91636678|NCT00890396|183165674|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
91636679|NCT00890396|183165675|SUPERIORITY|||||||0.85|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.85
91636680|NCT00890396|183165676|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.95
91636681|NCT00890396|183165677|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.40
91636682|NCT00890396|183165678|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
91636683|NCT04411472|183165679|SUPERIORITY||Odds Ratio (OR)|1.18||||0.8025|TWO_SIDED|95.0|0.805|1.732|||One-sided p-value|||||1.732|0.805|0.8025
91636684|NCT04411472|183165680|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1824|TWO_SIDED|95.0|0.139|2.131|||One-sided p-value|||||2.131|0.139|0.1824
91636685|NCT04411472|183165681|SUPERIORITY||Odds Ratio (OR)|0.02||||0.008|TWO_SIDED|95.0|0.001|0.405|||One-sided p-value|||||0.405|0.001|0.0080
91636686|NCT04411472|183165682|SUPERIORITY||Odds Ratio (OR)|0.94||||0.3894|TWO_SIDED|95.0|0.606|1.454|||One-sided p-value|||||1.454|0.606|0.3894
91636687|NCT04411472|183165683|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1237|TWO_SIDED|95.0|0.128|1.697|||One-sided p-value|||||1.697|0.128|0.1237
91636688|NCT04411472|183165685|SUPERIORITY||z-score statistic difference proportions|-7.9||||0.019|TWO_SIDED|95.0|-15.4|-0.4||one-sided p-value based on the z-score statistic for the difference in proportions|one-sided p-value|||||-0.4|-15.4|0.019
91636689|NCT04411472|183165686|SUPERIORITY|||||||0.546|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through to Day 28||||0.5460
91670099|NCT02102932|183235033|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.56|STANDARD_DEVIATION|14.0||0.0001|TWO_SIDED|90.0|97.56|112.07||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.07|97.56|0.0001
91670100|NCT02102932|183235033|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.8|STANDARD_DEVIATION|12.8||0.0001|TWO_SIDED|90.0|99.32|112.7||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.70|99.32|0.0001
91715123|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-1.96|||<|0.0001|TWO_SIDED|95.0|-2.37|-1.55|||Student's paired t-test|||Day 1||-1.55|-2.37|<.0001
91715124|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.83|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.83|<.0001
91636690|NCT04411472|183165686|SUPERIORITY|||||||0.677|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.6770
91636691|NCT04411472|183165686|SUPERIORITY|||||||0.993|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.9930
91636692|NCT04411472|183165686|SUPERIORITY|||||||0.779|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.7790
91636693|NCT04411472|183165687|SUPERIORITY|||||||0.051|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||0.0510
91636694|NCT04411472|183165687|SUPERIORITY|||||||0.013|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.0130
91636695|NCT04411472|183165687|SUPERIORITY|||||||0.025|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.0250
91636696|NCT04411472|183165687|SUPERIORITY|||||||0.073|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0730
91636697|NCT04411472|183165688|SUPERIORITY|||||||1|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||1.0000
91636698|NCT04411472|183165688|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.9790
91636699|NCT04411472|183165688|SUPERIORITY|||||||0.675|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.6750
91636700|NCT04411472|183165688|SUPERIORITY|||||||0.031|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0310
91636701|NCT04411472|183165689|SUPERIORITY|||||||0.545|||||||One-sided p-value from re-randomization|||||||0.5450
91636702|NCT04411472|183165690|SUPERIORITY|||||||0.081|||||||One-sided p-value from re-randomization|||||||0.0810
91636703|NCT04411472|183165691|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||||||0.9790
91636704|NCT04411472|183165692|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6916|TWO_SIDED|95.0|0.806|1.437|||One-sided p-value|||||1.437|0.806|0.6916
91636705|NCT04411472|183165693|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0628|TWO_SIDED|95.0|0.18|1.234|||One-sided p-value|||||1.234|0.180|0.0628
91636706|NCT04411472|183165694|SUPERIORITY||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED|95.0|0.001|0.054|||One-sided p-value|||||0.054|0.001|<0.0001
91636707|NCT00440232|183165695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.969||||0.172|TWO_SIDED|95.0|0.74|5.235|||Chi-squared|||||5.235|0.74|0.172
91636708|NCT00440232|183165696|SUPERIORITY_OR_OTHER||log rank chi square|1.247||||0.264||95.0|||||Log Rank|df=1||||||0.264
91636709|NCT00819052|183165697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12%|Cochran's statistic|1.0||||||95.0|-4.3|6.2|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||6.2|-4.3|
91636710|NCT00819052|183165710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64||||0.7587||95.0|-34.34|25.05|||ANCOVA|Means adjusted for background ARV (Antiretroviral) stratum||||25.05|-34.34|0.7587
91636711|NCT00362297|183165740|SUPERIORITY_OR_OTHER_LEGACY||Incident Risk Ratio|0.79||||0.052||95.0|0.63|1.0|||Regression, Poisson|Adjusted for period effects.||Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.||1.00|0.63|0.052
91636712|NCT00982111|183165768|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9561|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.9561
91636713|NCT00982111|183165769|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.6647|TWO_SIDED|95.0|0.8|1.16|||Log Rank|||||1.16|0.80|0.6647
91636714|NCT00982111|183165770|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.7945|TWO_SIDED|95.0|0.68|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.68|0.7945
91636715|NCT00982111|183165771|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18||||0.0459|TWO_SIDED|95.0|1.0|1.39|||Log Rank|||||1.39|1.00|0.0459
91636716|NCT00684073|183165780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.13||95.0||||p-value adjusted for treatment only|ANCOVA||Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.|||||0.130
91670101|NCT02102932|183235033|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.75|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|98.18|109.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.63|98.18|0.0000
91670102|NCT02102932|183235033|SUPERIORITY_OR_OTHER||Ratio of the geometric means|95.77|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|89.88|102.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||102.03|89.88|0.0000
91670103|NCT02102932|183235034|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.44|STANDARD_DEVIATION|11.8||0|TWO_SIDED|90.0|100.44|112.8||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.80|100.44|0.0000
91670104|NCT02102932|183235034|SUPERIORITY_OR_OTHER||Ratio of the geometric means|110.78|STANDARD_DEVIATION|13.2||0.0021|TWO_SIDED|90.0|103.8|118.24||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||118.24|103.80|0.0021
91670105|NCT02102932|183235034|SUPERIORITY_OR_OTHER||Ratio of the geometric means|101.38|STANDARD_DEVIATION|13.6||0|TWO_SIDED|90.0|94.82|108.39||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.39|94.82|0.0000
91670106|NCT02102932|183235034|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.02|STANDARD_DEVIATION|16.3||0.0002|TWO_SIDED|90.0|95.08|111.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.63|95.08|0.0002
91670107|NCT02102932|183235035|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.91|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|99.29|110.86||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||110.86|99.29|0.0000
91715125|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.53|||Student's paired t-test|||Day 3||-2.53|-3.41|<.0001
91715126|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-3.81|-2.87|||Student's paired t-test|||Day 4||-2.87|-3.81|<.0001
91636717|NCT01259388|183165785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.346|||||||t-test, 2 sided|||||||0.346
91636718|NCT01259388|183165787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91636719|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Group Mean Ratio|1.13|||||TWO_SIDED|96.67|1.02|1.25||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.25|1.02|
91670108|NCT02102932|183235035|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.32|STANDARD_DEVIATION|15.7||0.0008|TWO_SIDED|90.0|98.39|114.88||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||114.88|98.39|0.0008
91670109|NCT02102932|183235035|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.44|STANDARD_DEVIATION|15.7||0.0003|TWO_SIDED|90.0|96.68|112.82||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.82|96.68|0.0003
91670110|NCT02102932|183235035|SUPERIORITY_OR_OTHER||Ratio of the geometric means|96.61|STANDARD_DEVIATION|16.9||0.0004|TWO_SIDED|90.0|88.9|104.99||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||104.99|88.90|0.0004
91670111|NCT02102932|183235036|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.16|STANDARD_DEVIATION|6.2||0|TWO_SIDED|90.0|101.97|108.45||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.45|101.97|0.0000
91670112|NCT02102932|183235036|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.07|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.75|106.5||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.50|99.75|0.0000
91670113|NCT02102932|183235036|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.14|STANDARD_DEVIATION|7.5||0|TWO_SIDED|90.0|99.37|107.04||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.04|99.37|0.0000
91670114|NCT02102932|183235036|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.61|STANDARD_DEVIATION|7.0||0|TWO_SIDED|90.0|99.1|106.25||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.25|99.10|0.0000
91670115|NCT02102932|183235037|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.33|STANDARD_DEVIATION|11.9||0|TWO_SIDED|90.0|99.34|111.68||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.68|99.34|0.0000
91670116|NCT02102932|183235037|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.75|STANDARD_DEVIATION|13.2||0.0001|TWO_SIDED|90.0|99.09|112.85||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.85|99.09|0.0001
91670117|NCT02102932|183235037|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.9|STANDARD_DEVIATION|11.7||0|TWO_SIDED|90.0|97.11|109.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.03|97.11|0.0000
91715127|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-3.36|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.87|||Student's paired t-test|||Day 5||-2.87|-3.84|<.0001
91715128|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.56|||Student's paired t-test|||Change from Baseline at Day 6||-2.56|-3.91|<.0001
91670118|NCT02102932|183235037|SUPERIORITY_OR_OTHER||Ratio of the geometric means|93.84|STANDARD_DEVIATION|13.6||0.0002|TWO_SIDED|90.0|87.74|100.36||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||100.36|87.74|0.0002
91670119|NCT01263561|183235102|NON_INFERIORITY_OR_EQUIVALENCE|A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||.85
91525980|NCT03502616|182927258|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.603||0.0616|TWO_SIDED|95.0|-0.06|2.32|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.32|-0.06|0.0616
91636720|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.01|||||TWO_SIDED|96.67|0.91|1.12||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.12|0.91|
91636721|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratio|0.89|||||TWO_SIDED|96.67|0.8|0.99||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||0.99|0.80|
91636722|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.19|||||TWO_SIDED|96.67|0.74|1.93||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.93|0.74|
91636723|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.85|||||TWO_SIDED|96.67|0.52|1.38||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.38|0.52|
91636724|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.71|||||TWO_SIDED|96.67|0.44|1.15||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.15|0.44|
91636725|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.14|||||TWO_SIDED|96.67|1.01|1.3||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.30|1.01|
91636726|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.05|||||TWO_SIDED|96.67|0.93|1.19||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.19|0.93|
91636727|NCT00620815|183165788|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.92|||||TWO_SIDED|96.67|0.81|1.04||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.04|0.81|
91636728|NCT01032265|183165812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||95.0|||||Mixed Models Analysis|||analysis between groups||||0.27
91636729|NCT01032265|183165813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0|||||Mixed Models Analysis|||analysis between groups||||0.52
91636730|NCT01032265|183165814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Mixed Models Analysis|||analysis between groups||||0.30
91636731|NCT01032265|183165815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.02
91636732|NCT01032265|183165816|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
91636733|NCT01032265|183165817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23||95.0|||||negative binomial regression|||analysis between groups||||0.23
91636734|NCT01032265|183165818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.01
91636735|NCT02728804|183165824|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.29|0.66|0.65
91636736|NCT02728804|183165825|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.43|0.79|0.70
91636737|NCT02728804|183165826|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.87|TWO_SIDED|95.0|0.73|1.31|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.31|0.73|0.87
91636738|NCT02728804|183165827|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.92|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||0.92|0.48|0.01
91636739|NCT02728804|183165828|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.1|TWO_SIDED|95.0|0.95|1.87|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.87|0.95|0.10
91636740|NCT02728804|183165828|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.002|TWO_SIDED|95.0|1.28|2.89|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||2.89|1.28|0.002
91636741|NCT00453349|183165917|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population"|Mean Difference (Final Values)|-3.2||||||95.0|-10.7|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-10.7|
91670120|NCT01263561|183235103|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only for main outcome measure of IOP.||||||0.24|TWO_SIDED||||||Kaplan Meier|||||||.24
91670121|NCT01263561|183235104|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only performed for main outcome measure of IOP.||||||0.8|TWO_SIDED|||||Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.|Chi-squared|||||||0.80
91670122|NCT04728620|183235116|SUPERIORITY|single group|mean|79.3||||0.001|TWO_SIDED||||||t-test, 1 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is 71 or less."||||0.001
91670123|NCT04728620|183235118|OTHER||Mean Difference (Net)|0.57||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
91670124|NCT04728620|183235119|OTHER||Mean Difference (Net)|-0.85||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
91670125|NCT04728620|183235120|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended A1c monitoring frequency||||1
91670126|NCT04728620|183235120|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended urine microalbumin screening frequency||||1
91636742|NCT00453349|183165918|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-1.9||||||95.0|-9.9|6.0|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.0|-9.9|
91670127|NCT04728620|183235120|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequency||||1
91636743|NCT00453349|183165919|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-3.2||||||95.0|-7.4|0.8|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||0.8|-7.4|
91636744|NCT00453349|183165920|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
91636745|NCT00453349|183165921|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|5.4||||||95.0|-12.7|20.3|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||20.3|-12.7|
91670128|NCT04728620|183235120|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended diabetes eye exam frequency||||1
91670129|NCT00749658|183235132|OTHER|Two tailed testing||||||0.07|||||||SAS|||||||0.07
91715129|NCT05556148|183321429|OTHER||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.48|-2.92|||Student's paired t-test|||Day 7||-2.92|-4.48|<.0001
91670130|NCT01214239|183235139|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.71|-0.28|||ANCOVA|||||-0.28|-0.71|<0.0001
91670131|NCT01214239|183235140|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001||95.0|-0.527|-0.238|||ANCOVA|||||-0.238|-0.527|<0.0001
91670132|NCT01214239|183235141|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.677|-0.323|||ANCOVA|||||-0.323|-0.677|<0.0001
91670133|NCT01214239|183235142|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.512|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001||95.0|-0.705|-0.318|||ANCOVA|||||-0.318|-0.705|<0.0001
91670134|NCT01214239|183235143|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.69|-0.23|||ANCOVA|||||-0.23|-0.69|0.0001
91715130|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.17|-1.34|||Student's paired t-test|||Day 1||-1.34|-2.17|<.0001
91485224|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
91670135|NCT01214239|183235144|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.1||0.0003||95.0|-17.2|-5.2|||ANCOVA|||||-5.2|-17.2|0.0003
91670136|NCT01214239|183235145|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.8|STANDARD_ERROR_OF_MEAN|3.3||0.0086||95.0|-15.4|-2.3|||ANCOVA|||||-2.3|-15.4|0.0086
91670137|NCT01214239|183235146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.5|STANDARD_ERROR_OF_MEAN|3.8||0.0135||95.0|-17.0|-2.0|||ANCOVA|||||-2.0|-17.0|0.0135
91670138|NCT01214239|183235147|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|3.8||0.0113||95.0|-17.1|-2.2|||ANCOVA|||||-2.2|-17.1|0.0113
91670139|NCT01214239|183235149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.552||||0.0021||95.0|1.407|4.629|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 7.0%||4.629|1.407|0.0021
91485225|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.15|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.42|<0.001
91670140|NCT01214239|183235151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.583||||0.25||95.0|0.724|3.46|||Regression, Logistic|||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||3.46|0.724|0.2500
91485226|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.53|<0.001
91485227|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.29|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.29|0.032
91670141|NCT01214239|183235152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.527||||0.0005||95.0|1.494|4.276|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||||4.276|1.494|0.0005
91670142|NCT00810602|183235153|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|22.0|||||TWO_SIDED|95.0|13.0|36.0||||||Hypothesis: The addition of vorinostat will reduce the incidence of grade 2-4 acute graft versus host disease (GVHD) to 25% or lower by day 100.||36|13|
91670143|NCT00810602|183235155|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|16.0|||||TWO_SIDED|95.0|8.0|30.0||||||||30|8|
91670144|NCT02625298|183235169|OTHER||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91670145|NCT04773600|183235202|SUPERIORITY||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.962|5.183|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA Success at Week 4||5.183|1.962|<0.0001
91670146|NCT04773600|183235203|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.0001|TWO_SIDED|95.0|1.996|5.687|||Cochran-Mantel-Haenszel|Stratified by pooled study site|Stratified by pooled study site|vIGA Success at Week 4 in Participants with Baseline vIGA = 'Moderate'||5.687|1.996|<0.0001
91670147|NCT04773600|183235204|SUPERIORITY||Odds Ratio (OR)|4.42|||<|0.0001|TWO_SIDED|95.0|2.281|8.658|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 2||8.658|2.281|<0.0001
91670148|NCT04773600|183235205|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1156|TWO_SIDED|95.0|0.832|4.782|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 1||4.782|0.832|0.1156
91670149|NCT04773600|183235206|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0014|TWO_SIDED|95.0|1.448|5.066|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 4||5.066|1.448|0.0014
91525981|NCT03502616|182927258|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|0.681||0.0455|TWO_SIDED|95.0|0.03|2.71|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.71|0.03|0.0455
91670150|NCT04773600|183235207|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0015|TWO_SIDED|95.0|1.591|7.927|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 2||7.927|1.591|0.0015
91670151|NCT04773600|183235208|SUPERIORITY||Odds Ratio (OR)|7.84||||0.002|TWO_SIDED|95.0|1.717|35.764|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 1||35.764|1.717|0.0020
91670152|NCT04773600|183235209|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.108|4.964|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|EASI-75 at Week 4||4.964|2.108|<0.0001
91670153|NCT04773600|183235210|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.191|5.24|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||5.240|2.191|<0.0001
91670154|NCT04773600|183235211|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.097|5.854|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.854|2.097|<0.0001
91670155|NCT04773600|183235212|SUPERIORITY||Odds Ratio (OR)|2.56||||0.005|TWO_SIDED|95.0|1.312|4.993|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||4.993|1.312|0.0050
91715131|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.67|||Student's paired t-test|||Day 2||-1.67|-2.51|<.0001
91670156|NCT01923311|183235219|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|135.73|||||TWO_SIDED|90.0|116.24|158.49||||||To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||158.49|116.24|
91670157|NCT01923311|183235220|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|146.68|||||TWO_SIDED|90.0|127.35|168.94||||||To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||168.94|127.35|
91670158|NCT02304406|183235242|OTHER||Odds Ratio (OR)|1.85||||0.1304|TWO_SIDED|95.0|0.8|4.77|||Cochran-Mantel-Haenszel|||||4.77|0.80|0.1304
91670159|NCT02304406|183235243|OTHER|||||||0.6422|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6422
91670160|NCT02304406|183235244|OTHER|||||||0.4524|||||||Cochran-Mantel-Haenszel|||||||0.4524
91670161|NCT02304406|183235245|OTHER|||||||0.901|||||||Cochran-Mantel-Haenszel|||||||0.9010
91670162|NCT02304406|183235246|OTHER|||||||0.9067|||||||Cochran-Mantel-Haenszel|||||||0.9067
91715132|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.86|-1.97|||Student's paired t-test|||Day 3||-1.97|-2.86|<.0001
91485228|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|-0.33|-0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.33|0.006
91670163|NCT02304406|183235247|OTHER|||||||0.8785|||||||Cochran-Mantel-Haenszel|||||||0.8785
91670164|NCT02304406|183235248|OTHER|||||||0.9231|||||||Cochran-Mantel-Haenszel|||||||0.9231
91670165|NCT02304406|183235249|OTHER|||||||0.978|||||||Cochran-Mantel-Haenszel|||||||0.9780
91670166|NCT02304406|183235250|OTHER|||||||0.1144|||||||Cochran-Mantel-Haenszel|||||||0.1144
91670167|NCT02304406|183235251|OTHER|||||||0.0862|||||||Cochran-Mantel-Haenszel|||||||0.0862
91670168|NCT02304406|183235252|OTHER|||||||0.0294|||||||Cochran-Mantel-Haenszel|||||||0.0294
91670169|NCT02304406|183235253|OTHER|||||||0.6877|||||||Cochran-Mantel-Haenszel|||||||0.6877
91670170|NCT01560819|183235261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Wilcoxon signed rank test|||A power calculation was not done for this pilot study. Changes in PUCAI post-treatment were compared with baseline using the Wilcoxon signed rank test. P value \<0.05 was considered statistically significant.||||0.03
91715133|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-2.74|||<|0.0001|TWO_SIDED|95.0|-3.22|-2.27|||Student's paired t-test|||Day 4||-2.27|-3.22|<.0001
91485229|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.009|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.009
91485230|NCT00809354|182843574|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.41|<0.001
91670171|NCT04403399|183235285|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
91670172|NCT04403399|183235286|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
91670173|NCT04403399|183235287|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
91670174|NCT00831233|183235295|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-2.95||||0.1973|TWO_SIDED|95.0|-7.51|1.61||FAS.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.61|-7.51|0.1973
91670175|NCT00831233|183235295|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-5.88||||0.0398|TWO_SIDED|95.0|-11.5|-0.291||PP analysis set.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||-0.291|-11.5|0.0398
91670176|NCT00831233|183235296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47||||0.2298|TWO_SIDED|95.0|-6.58|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-6.58|0.2298
91715134|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.16|||Student's paired t-test|||Day 5||-2.16|-3.30|<.0001
91715135|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.56|-2.19|||Student's paired t-test|||Day 6||-2.19|-3.56|<.0001
91525982|NCT03502616|182927259|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-1.25|-0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.52|-1.25|<0.0001
91525983|NCT03502616|182927259|SUPERIORITY||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.215|<|0.0001|TWO_SIDED|95.0|-1.65|-0.8|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.65|<0.0001
91636746|NCT00453349|183165922|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|4.3||||||95.0|-19.4|17.6|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||17.6|-19.4|
91636747|NCT00453349|183165923|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-2.5||||||95.0|-8.6|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-8.6|
91636748|NCT00453349|183165924|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
91636749|NCT00453349|183165925|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-7.9||||||95.0|-24.9|15.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||15.9|-24.9|
91636750|NCT00453349|183165926|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|3.7||||||95.0|-30.5|11.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||11.9|-30.5|
91636751|NCT00149227|183165978|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|-0.975|0.975|||Cox's proportional hazard analysis|||"We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.~with a two-tailed 5% statistical signiﬁcant level."||0.975|-0.975|<0.05
91636752|NCT02978339|183165992|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
91636753|NCT02978339|183165993|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91636754|NCT02978339|183165994|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||||||0.91
91636755|NCT02978339|183165995|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91670177|NCT00831233|183235296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983||||0.6917|TWO_SIDED|95.0|-5.98|4.02|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.02|-5.98|0.6917
91670178|NCT00831233|183235297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.553||||0.8151|TWO_SIDED|95.0|-5.33|4.22|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.22|-5.33|0.8151
91636756|NCT02978339|183165996|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||.15
91636757|NCT02978339|183165997|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||.06
91636758|NCT02978339|183165998|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||.93
91636759|NCT00195702|183166004|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
91636760|NCT00195702|183166004|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
91636761|NCT00195702|183166005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
91670179|NCT00831233|183235297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.455|TWO_SIDED|95.0|-2.46|5.38|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||5.38|-2.46|0.455
91670180|NCT00831233|183235297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.3186|TWO_SIDED|95.0|-2.04|6.08|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||6.08|-2.04|0.3186
91670181|NCT00831233|183235298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.5627|TWO_SIDED|95.0|-37.8|68.2|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||68.2|-37.8|0.5627
91670182|NCT00831233|183235298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91||||0.8284|TWO_SIDED|95.0|-49.1|60.9|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||60.9|-49.1|0.8284
91670183|NCT00831233|183235298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.5984|TWO_SIDED|95.0|-34.4|58.8|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||58.8|-34.4|0.5984
91636762|NCT00195702|183166005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
91636763|NCT00195702|183166006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91670184|NCT00831233|183235299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.83||||0.1018|TWO_SIDED|95.0|-17.3|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-17.3|0.1018
91670185|NCT00991510|183235305|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.923|||||TWO_SIDED|90.0|0.865|0.984|||ANOVA|||A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.||0.984|0.865|
91670186|NCT00991510|183235306|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.959|||||TWO_SIDED|90.0|0.899|1.023|||ANOVA|||||1.023|0.899|
91636764|NCT00195702|183166006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91670187|NCT00991510|183235307|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.873|||||TWO_SIDED|90.0|0.787|0.968|||ANOVA|||||0.968|0.787|
91670188|NCT00991510|183235308|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.985|||||TWO_SIDED|90.0|0.877|1.106|||ANOVA|||||1.106|0.877|
91670189|NCT01976728|183235330|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.012||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||The primary efficacy analysis compared the pooled ovulation rate of the LutrePulse 15 μg and 20 μg group to placebo.||||0.0120
91670190|NCT01976728|183235331|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0553||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||P4 levels of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0553
91715136|NCT05556148|183321430|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.01|-2.39|||Student's paired t-test|||Day 7||-2.39|-4.01|<.0001
91715137|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.35|-1.51|||Student's paired t-test|||Day 1||-1.51|-2.35|<.0001
91636765|NCT00195702|183166007|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
91636766|NCT00195702|183166007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91636767|NCT00195702|183166008|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91636768|NCT00195702|183166008|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91715138|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.2|||Student's paired t-test|||Day 2||-2.20|-3.00|<.0001
91636769|NCT00195702|183166009|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
91636770|NCT00195702|183166009|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
91636771|NCT00195702|183166010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91636772|NCT00195702|183166010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91636773|NCT00195702|183166012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91636774|NCT00195702|183166012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91636775|NCT00195702|183166016|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91636776|NCT00195702|183166016|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91636777|NCT01078389|183166035|SUPERIORITY_OR_OTHER|||||||0.472|||||||Ranked Analysis of Covariance (ANCOVA)|Baseline modified Sharp/van der Heijde Erosion Score as a covariate.||Change from Baseline at Month 24||||0.472
91636778|NCT01078389|183166036|SUPERIORITY_OR_OTHER|||||||0.548|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.548
91636779|NCT01078389|183166037|SUPERIORITY_OR_OTHER|||||||0.389|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.389
91636780|NCT01078389|183166038|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|Baseline RAMRIS Synovitis Score as a covariate.||Synovitis: Change from Baseline at Month 24||||<0.001
91636781|NCT01078389|183166038|SUPERIORITY_OR_OTHER|||||||0.634|||||||Ranked ANCOVA|Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.||Erosion(Distal+Proximal): Change from Baseline at Month 24||||0.634
91636782|NCT01078389|183166038|SUPERIORITY_OR_OTHER|||||||0.307|||||||Ranked ANCOVA|Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.||Edema(Distal+Proximal): Change from Baseline at Month 24||||0.307
91636783|NCT01078389|183166039|SUPERIORITY_OR_OTHER|||||||0.122|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score as a covariate.||Change from Baseline at Month 24||||0.122
91636784|NCT04823494|183166040|NON_INFERIORITY|For sample size in each sequence group is 16 (total N=32), a 2 X 2 crossover design will have 80% power to reject the null hypothesis that the SELF-FIT APHAB mean is inferior to the PRO-FIT APHAB mean. The non-inferiority difference margin is 8.4, the standard deviation of differences is 16.3, and p\<.025. The non-inferiority margin of 8.4 preserves half the 95% critical difference for the global APHAB score (16.8). The common standard deviation reported for the APHAB global score is 16.0.|Mean Difference (Final Values)|1.4|||<|0.025|TWO_SIDED|95.0|-1.59|4.73||There were two outcome measures, primary and secondary, considered. As a result, the a priori p value of .05 for statistical significance was adjusted for multiple comparisons to .025.|t-test, 1 sided|The mean differences and 95% CIs in APHAB global score between SELF-FIT and PRO-FIT were calculated using bias-corrected \& accelerated bootstrapping.|The mean difference and 95% CIs are for Self-Fit minus Pro-Fit aided scores. These values are the pooled data for all 37 participants, 19 receiving one sequence and 18 the other sequence.|"For the wear-time crossover field trial, the APHAB was measured following both the audiology best-practices hearing aid fitting (PRO-FIT) and the self-fitting method (SELF-FIT).~* Null hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT ) ≥ 8.4~* Alternative hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT) \< 8.4~The mean difference between the aided scores for the two fitting methods, Self-Fit minus Pro-Fit, represent the primary outcome measure. The expected difference = 0."||4.73|-1.59|<0.025
91636785|NCT04823494|183166041|NON_INFERIORITY|For the QuickSIN, a clinically meaningful difference is 3 dB and half that difference resulted in a margin of 1.5 dB. This 1.5-dB margin was used for the QuickSIN for the non-inferiority analyses of the data from the field-trial component. The mean difference, QuickSIN Self-Fit minus QuickSIN Pro-Fit, should be less than 1.5 dB for the entire sample (N=37) to meet the non-inferiority criterion.|Mean Difference (Final Values)|0.58|||<|0.025|TWO_SIDED|95.0|-0.03|1.2||The a priori threshold value of 0.05 was Bonferroni-adjusted to 0.025 based on the use of two outcome measures, APHAB global (primary) and QuickSIN (secondary).|t-test, 1 sided|The mean differences in dB, SELF-FIT minus PRO-FIT, were calculated with 95% confidence intervals (bias-corrected, accelerated bootstrap) generated.|Mean differences in aided QuickSIN SNR in dB, Self-Fit minus Pro-Fit, were calculated for the entire group of 37 participants with about 1/2 receiving one of the two fit sequences (Pro-Fit then Self-Fit or Self-Fit then Pro-Fit).|"For the QuickSIN, aided performance after each wear period was compared between SELF-FIT and PRO-FIT.~* Null hypothesis: Mean (QuickSIN SELF-FIT - QuickSIPRO-FIT) ≥ 1.5 dB~* Alternative hypothesis: Mean (QuickSIN SELF-FIT - QuickSIN PRO-FIT) \< 1.5 dB~Power calculations were based on the primary outcome measured, the aided APHAB global score, (see information for that outcome measure). With the minimum required N of 32 based on the APHAB global score, the power for QuickSIN exceeded 80%."||1.20|-0.03|<0.025
91715139|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.09|-2.22|||Student's paired t-test|||Day 3||-2.22|-3.09|<.0001
91636786|NCT03691831|183166054|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0001|TWO_SIDED|95.0|2.14|10.76||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||10.76|2.14|0.0001
91715140|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.62|||Student's paired t-test|||Day 4||-2.62|-3.53|<.0001
91636787|NCT03691831|183166055|SUPERIORITY||Mean Difference (Final Values)|2.71||||0.0001|TWO_SIDED|95.0|1.61|4.56|||Mixed Models Analysis|||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.||4.56|1.61|0.0001
91636788|NCT03691831|183166056|SUPERIORITY||Odds Ratio (OR)|15.44|||<|0.0001|TWO_SIDED|95.0|9.0|21.8|||Wilcoxon (Mann-Whitney)|||||21.8|9.0|<0.0001
91636789|NCT03691831|183166057|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0006|TWO_SIDED|95.0|1.76|15.53|||Wilcoxon (Mann-Whitney)|||||15.53|1.76|0.0006
91636790|NCT03691831|183166058|SUPERIORITY||Hazard Ratio (HR)|3.33|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91636791|NCT00337935|183166066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0062|TWO_SIDED|95.0|0.2|0.9||a priori theshold for statistical significance was p=0.05|ANCOVA|Baseline Hemoglobin was used as a covariate.||||0.9|0.2|.0062
91636792|NCT00337935|183166067|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance p=0.05|Chi-squared|||||||<0.001
91636793|NCT00337935|183166068|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A priori threshold for statistical significance p=0.05|Log Rank|||||||<0.0001
91636794|NCT02361307|183166087|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91636795|NCT00329433|183166088|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of \<0.05.||||<0.05
91636796|NCT00329433|183166089|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91636797|NCT00329433|183166090|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91636798|NCT01189201|183166101|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.9|STANDARD_DEVIATION|7.2|||TWO_SIDED|90.0|102.07|107.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability||107.80|102.07|
91636799|NCT01189201|183166102|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.91|STANDARD_DEVIATION|12.8|||TWO_SIDED|90.0|99.97|110.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||110.09|99.97|
91636800|NCT01189201|183166103|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|107.68|STANDARD_DEVIATION|15.3|||TWO_SIDED|90.0|101.7|114.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||114.02|101.70|
91636801|NCT01189201|183166104|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|109.68|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|99.55|120.83|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||120.83|99.55|
91636802|NCT01189201|183166107|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.78|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|102.02|107.61|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||107.61|102.02|
91636803|NCT01189201|183166108|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.64|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|97.23|112.62|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||112.62|97.23|
91636804|NCT01189201|183166109|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.86|STANDARD_DEVIATION|9.3|||TWO_SIDED|90.0|81.33|90.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.64|81.33|
91636805|NCT01189201|183166110|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|61.41|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|54.1|69.71|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||69.71|54.10|
91715141|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-3.25|||<|0.0001|TWO_SIDED|95.0|-3.76|-2.75|||Student's paired t-test|||Day 5||-2.75|-3.76|<.0001
91715142|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-3.41|||<|0.0001|TWO_SIDED|95.0|-4.04|-2.78|||Student's paired t-test|||Day 6||-2.78|-4.04|<.0001
91715143|NCT05556148|183321431|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.64|||Student's paired t-test|||Day 7||-2.64|-4.30|<.0001
91636806|NCT01189201|183166111|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.32|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|80.77|90.14|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.14|80.77|
91636807|NCT01189201|183166112|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|93.18|STANDARD_DEVIATION|15.7|||TWO_SIDED|90.0|85.07|102.05|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||102.05|85.07|
91636808|NCT01189201|183166113|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|68.48|STANDARD_DEVIATION|27.2|||TWO_SIDED|90.0|58.59|80.03|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||80.03|58.59|
91636809|NCT01189201|183166114|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|90.95|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|84.24|98.19|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||98.19|84.24|
91636810|NCT01189201|183166115|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.64|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|91.19|100.3|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.30|91.19|
91636811|NCT01189201|183166116|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|98.04|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|91.95|104.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||104.53|91.95|
91636812|NCT01189201|183166117|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.69|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|91.17|100.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.43|91.17|
91636813|NCT01189201|183166118|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|92.98|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|86.36|100.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.09|86.36|
91636814|NCT01189201|183166119|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|103.71|STANDARD_DEVIATION|22.4|||TWO_SIDED|90.0|92.93|115.74|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||115.74|92.93|
91636815|NCT01189201|183166120|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|96.36|STANDARD_DEVIATION|14.3|||TWO_SIDED|90.0|89.78|103.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||103.42|89.78|
91670191|NCT01976728|183235332|SUPERIORITY|The hypotheses was tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0383||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Clinical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0383
91670192|NCT01976728|183235333|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0246||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Biochemical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0246
91636816|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccine Group Differences at Day 86|19.0|||||TWO_SIDED|97.5|10.0|28.9|||MN method|||Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA||28.9|10|
91636817|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccine Group Differences at Day 86|27.0|||||TWO_SIDED|97.5|16.9|37.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC||37.7|16.9|
91636818|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccine Group Differences at Day 86|14.0|||||TWO_SIDED|97.5|1.4|26.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW||26.7|1.4|
91715144|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-2.07|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.66|||Student's paired t-test|||Day 1||-1.66|-2.49|<.0001
91715145|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.33|||Student's paired t-test|||Day 2||-2.33|-3.20|<.0001
91636819|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y|Vaccine Group differences at Day 86|27.0|||||TWO_SIDED|97.5|15.6|37.6|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY||37.6|15.6|
91670193|NCT01976728|183235334|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0011||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||LH surge detection of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0011
91670194|NCT01976728|183235335|SUPERIORITY|||||||0.1344||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1344
91670195|NCT01976728|183235335|SUPERIORITY|||||||0.2726||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2726
91670196|NCT01976728|183235335|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
91670197|NCT01976728|183235335|SUPERIORITY|||||||0.1275||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1275
91670198|NCT01976728|183235335|SUPERIORITY|||||||0.1088||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1088
91715146|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-3.21|||<|0.0001|TWO_SIDED|95.0|-3.63|-2.78|||Student's paired t-test|||Day 3||-2.78|-3.63|<.0001
91636820|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccines Group Differences at Day 86|11.0|||||TWO_SIDED|97.5|1.7|21.3|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA||21.3|1.7|
91670199|NCT01976728|183235335|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
91715147|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-3.49|||<|0.0001|TWO_SIDED|95.0|-3.98|-3.0|||Student's paired t-test|||Day 4||-3.00|-3.98|<.0001
91715148|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.33|-3.33|||Student's paired t-test|||Day 5||-3.33|-4.33|<.0001
91715149|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-4.05|||<|0.0001|TWO_SIDED|95.0|-4.65|-3.46|||Student's paired t-test|||Day 6||-3.46|-4.65|<.0001
91670200|NCT01976728|183235335|SUPERIORITY|||||||0.0796||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.0796
91670201|NCT01976728|183235335|SUPERIORITY|||||||0.1757||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.1757
91715150|NCT05556148|183321432|OTHER||Mean Difference (Final Values)|-4.13|||<|0.0001|TWO_SIDED|95.0|-4.81|-3.46|||Student's paired t-test|||Day 7||-3.46|-4.81|<.0001
91715151|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.77|||Student's paired t-test|||Day 1||-1.77|-2.66|<.0001
91715152|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.15|-2.31|||Student's paired t-test|||Day 2||-2.31|-3.15|<.0001
91715153|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.73|||Student's paired t-test|||Day 3||-2.73|-3.60|<.0001
91715154|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-3.52|||<|0.0001|TWO_SIDED|95.0|-4.0|-3.05|||Student's paired t-test|||Day 4||-3.05|-4.00|<.0001
91715155|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-3.73|||<|0.0001|TWO_SIDED|95.0|-4.19|-3.27|||Student's paired t-test|||Day 5||-3.27|-4.19|<.0001
91636821|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccines Group differences at Day 86|19.0|||||TWO_SIDED|97.5|9.9|29.2|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC||29.2|9.9|
91670202|NCT01976728|183235335|SUPERIORITY|||||||0.0584||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0584
91670203|NCT01976728|183235335|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
91670204|NCT01976728|183235335|SUPERIORITY|||||||0.0143||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0143
91670205|NCT01976728|183235335|SUPERIORITY|||||||0.006||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0060
91670206|NCT01976728|183235335|SUPERIORITY|||||||0.1573||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1573
91670207|NCT01976728|183235336|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
91670208|NCT01976728|183235336|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
91715156|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.55|-3.45|||Student's paired t-test|||Day 6||-3.45|-4.55|<.0001
91715157|NCT05556148|183321433|OTHER||Mean Difference (Final Values)|-4.07|||<|0.0001|TWO_SIDED|95.0|-4.74|-3.39|||Student's paired t-test|||Day 7||-3.39|-4.74|<.0001
91525984|NCT03502616|182927259|SUPERIORITY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|-2.17|-1.26|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.26|-2.17|<0.0001
91636822|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccines Group Differences at Day 86|4.0|||||TWO_SIDED|97.5|-8.6|17.4|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW||17.4|-8.6|
91670209|NCT01976728|183235336|SUPERIORITY|||||||0.2636||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2636
91670210|NCT01976728|183235336|SUPERIORITY|||||||0.4795||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4795
91670211|NCT01976728|183235336|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
91670212|NCT01976728|183235336|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
91670213|NCT01976728|183235336|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
91715158|NCT03191799|183321452|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
91715159|NCT03191799|183321452|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
91715160|NCT03191799|183321452|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
91670214|NCT01976728|183235336|SUPERIORITY|||||||0.0838||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0838
91670215|NCT01976728|183235336|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
91670216|NCT01976728|183235336|SUPERIORITY|||||||0.3778||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3778
91636823|NCT01682876|183166122|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY|Vaccines Group Differences at Day 86|29.0|||||TWO_SIDED|97.5|18.4|40.0|||MN method|||Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY||40|18.4|
91636824|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|18.0|||||TWO_SIDED|98.75|9.1|28.0|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||28|9.1|
91636825|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|28.0||||||98.75|17.1|38.7|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||38.7|17.1|
91636826|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|14.0|||||TWO_SIDED|98.75|1.0|27.1|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||27.1|1|
91670217|NCT01976728|183235337|SUPERIORITY||Least square mean (LSM) difference|1.35||||0.6732|TWO_SIDED|95.0|-5.16|7.87||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% confidence interval (CI) for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 10 µg group were compared to placebo using an analysis of covariance (ANCOVA) model including the randomization scheme and treatment group as factors and baseline value as covariate.||7.87|-5.16|0.6732
91636827|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine groups Differences at Day 86|28.0|||||TWO_SIDED|98.75|16.2|39.3|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.3|16.2|
91636828|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine groups differences at Day 86|11.0|||||TWO_SIDED|98.75|1.0|21.2|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||21.2|1|
91636829|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|18.0|||||TWO_SIDED|97.5|9.5|27.1|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||27.1|9.5|
91636830|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|5.0|||||TWO_SIDED|98.75|-8.4|18.8|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||18.8|-8.4|
91715161|NCT03191799|183321452|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
91715162|NCT03191799|183321452|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
91715163|NCT03191799|183321454|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
91715164|NCT03191799|183321454|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
91715165|NCT03191799|183321454|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
91715166|NCT03191799|183321454|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
91636831|NCT01682876|183166123|SUPERIORITY_OR_OTHER||Vaccine group Differences at Day 86|29.0|||||TWO_SIDED|98.75|17.0|39.6|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.6|17|
91636832|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.17|4.53||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||4.53|1.17|
91636833|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.75|||||TWO_SIDED|95.0|1.18|6.36||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||6.36|1.18|
91636834|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.85|1.34||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM||1.34|0.85|
91670218|NCT01976728|183235337|SUPERIORITY||LSM|5.7||||0.0814|TWO_SIDED|95.0|-0.76|12.15||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||12.15|-0.76|0.0814
91670219|NCT01976728|183235337|SUPERIORITY||LSM difference|7.55||||0.0223|TWO_SIDED|95.0|1.16|13.93||p-value for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||13.93|1.16|0.0223
91670220|NCT01976728|183235338|SUPERIORITY||LSM difference|0.679||||0.7355|TWO_SIDED|95.0|-3.404|4.762||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 10 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||4.762|-3.404|0.7355
91670221|NCT01976728|183235338|SUPERIORITY||LSM difference|2.602||||0.198|TWO_SIDED|95.0|-1.444|6.648||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||6.648|-1.444|0.1980
91670222|NCT01976728|183235338|SUPERIORITY||LSM difference|4.88||||0.0187|TWO_SIDED|95.0|0.878|8.882||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||8.882|0.878|0.0187
91670223|NCT01976728|183235339|SUPERIORITY||LSM difference|0.03||||0.8772|TWO_SIDED|95.0|-0.39|0.46||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.46|-0.39|0.8772
91670224|NCT01976728|183235339|SUPERIORITY||LSM difference|0.07||||0.7805|TWO_SIDED|95.0|-0.44|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.44|0.7805
91670225|NCT01976728|183235339|SUPERIORITY||LSM difference|0.12||||0.6095|TWO_SIDED|95.0|-0.35|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.35|0.6095
91670226|NCT01976728|183235340|SUPERIORITY||LSM difference|0.51||||0.152|TWO_SIDED|95.0|-0.2|1.22||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.22|-0.20|0.1520
91670227|NCT01976728|183235340|SUPERIORITY||LSM difference|0.93||||0.0221|TWO_SIDED|95.0|0.14|1.72||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.72|0.14|0.0221
91670228|NCT01976728|183235340|SUPERIORITY||LSM difference|0.76||||0.0316|TWO_SIDED|95.0|0.07|1.44||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.44|0.07|0.0316
91715167|NCT03191799|183321454|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
91715168|NCT03191799|183321465|SUPERIORITY|||||||0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||0.0001
91715169|NCT03191799|183321465|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
91636835|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM||1.42|0.54|
91636836|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.76|1.52||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM||1.52|0.76|
91636837|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.74|1.43||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM||1.43|0.74|
91636838|NCT01682876|183166128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||1.74|0.33|
91636839|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.77|2.65||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||2.65|0.77|
91670229|NCT01976728|183235342|SUPERIORITY||LSM difference|73.0||||0.3147|TWO_SIDED|95.0|-72.66|218.65||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||218.65|-72.66|0.3147
91670230|NCT01976728|183235342|SUPERIORITY||LSM difference|95.18||||0.229|TWO_SIDED|95.0|-63.01|253.36||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||253.36|-63.01|0.2290
91715170|NCT03191799|183321465|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
91715171|NCT03191799|183321465|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
91715172|NCT03191799|183321465|SUPERIORITY|||||||0.0004|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||0.0004
91636840|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|0.81|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||2.74|0.81|
91636841|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|1.04|1.55||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM||1.55|1.04|
91636842|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.81|||||TWO_SIDED|95.0|0.98|3.33||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM||3.33|0.98|
91636843|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.77|2.17||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM||2.17|0.77|
91636844|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65|||||TWO_SIDED|95.0|1.06|2.57||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM||2.57|1.06|
91636845|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.37|||||TWO_SIDED|95.0|0.99|1.89||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM||1.89|0.99|
91636846|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.07|||||TWO_SIDED|95.0|0.97|4.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM||4.42|0.97|
91636847|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.83|||||TWO_SIDED|95.0|1.22|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM||2.74|1.22|
91636848|NCT01682876|183166129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.48|2.68||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||2.68|0.48|
91636849|NCT03852901|183166140|OTHER||Mean Difference (Final Values)|40.717|STANDARD_ERROR_OF_MEAN|4.866|<|0.001|TWO_SIDED|95.0|31.166|50.268||Type III of fixed effects. Num df = 1; Den df = 902.758; F = 70.003; Sig. \< 0.001 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||50.268|31.166|<0.001
91636850|NCT03852901|183166141|OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|1.051||0.545|TWO_SIDED|95.0|-2.699|1.426||Type III of fixed effects. Num df = 1; Den df = 884.229; F = .367; Sig = .545 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||1.426|-2.699|0.545
91636851|NCT03852901|183166142|OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.009||0.003|TWO_SIDED|95.0|0.009|0.044||Type III of fixed effects. Num df = 1; Den df = 880.629; F = 8.782; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||.044|.009|0.003
91670231|NCT01976728|183235342|SUPERIORITY||LSM difference|46.99||||0.5066|TWO_SIDED|95.0|-95.64|189.61||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||189.61|-95.64|0.5066
91670232|NCT03180801|183235360|OTHER|||||||0.03|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.03
91670233|NCT03180801|183235360|OTHER|||||||0.07|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.07
91670234|NCT03180801|183235361|OTHER|One sided Fisher's exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.||||||0.647|||||||Fisher Exact|||One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.||||0.647
91670235|NCT03180801|183235361|OTHER|||||||1|||||||Fisher Exact|||One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.||||1.00
91670236|NCT03180801|183235361|OTHER|||||||0.024|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.0240
91670237|NCT03180801|183235361|OTHER|||||||0.186|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.186
91670238|NCT03180801|183235363|OTHER|||||||0.465|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.465
91670239|NCT03180801|183235363|OTHER|||||||0.074|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.074
91670240|NCT03180801|183235363|OTHER|||||||0.024|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms||||0.024
91670241|NCT03180801|183235363|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.||||0.230
91670242|NCT03180801|183235363|OTHER|||||||0.09|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.09
91670243|NCT03180801|183235363|OTHER|||||||0.22|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.22
91670244|NCT03180801|183235363|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.23
91670245|NCT03180801|183235363|OTHER|||||||0.12|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.12
91670246|NCT03180801|183235364|OTHER|||||||0.0501|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.0501
91670247|NCT03180801|183235364|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.3139
91670248|NCT03180801|183235365|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.||||0.102
91670249|NCT03180801|183235365|OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.||||0.481
91670250|NCT03180801|183235366|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.128
91670251|NCT03180801|183235366|OTHER|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.601
91670252|NCT03180801|183235367|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.142
91670253|NCT03180801|183235367|OTHER|||||||0.147|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.147
91670254|NCT03180801|183235368|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.080
91670255|NCT03180801|183235368|OTHER|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.271
91670256|NCT03180801|183235369|OTHER|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.099
91670257|NCT03180801|183235369|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.178
91670258|NCT03180801|183235370|OTHER|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.064
91670259|NCT03180801|183235370|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.201
91670260|NCT03180801|183235371|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison on day -2||||<0.001
91670261|NCT03180801|183235371|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparion on day -2||||<0.001
91670262|NCT03180801|183235371|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
91670263|NCT03180801|183235371|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
91670264|NCT03180801|183235371|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
91670265|NCT03180801|183235371|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
91670266|NCT03173170|183235376|OTHER||Mean ratio|1.0622|||||TWO_SIDED|90.0|0.9569|1.1792||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90 percent (%) confidence intervals (CIs).||1.1792|0.9569|
91715173|NCT03191799|183321467|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
91636852|NCT03852901|183166143|OTHER||Mean Difference (Final Values)|-2.647|STANDARD_ERROR_OF_MEAN|1.329||0.047|TWO_SIDED|95.0|-5.255|-0.04||Type III of fixed effects. Num df = 1; Den df = 880.870; F = 3.970; Sig. = 0.047 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-0.040|-5.255|0.047
91636853|NCT03852901|183166144|OTHER||Mean Difference (Final Values)|-5.573|STANDARD_ERROR_OF_MEAN|1.853||0.003|TWO_SIDED|95.0|-9.21|-1.937||Type III of fixed effects. Num df = 1; Den df = 902.181; F = 9.049; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: repeated-measures. Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-1.937|-9.210|0.003
91636854|NCT03852901|183166145|OTHER|||||||0.5849||||||Type III of fixed effects. Num df: 2; Den df = 33; F = 0.5451; Sig. = 0.5849 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.5849
91636855|NCT03852901|183166146|OTHER|||||||0.0142||||||Type III of fixed effects. Num df = 2; Den df = 35; F = 4.8191; Sig. = 0.0142 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.0142
91670267|NCT03173170|183235377|OTHER||Mean ratio|1.4892|||||TWO_SIDED|90.0|1.3851|1.6012||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.6012|1.3851|
91670268|NCT00573170|183235378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.378|TWO_SIDED|95.0|0.7|2.5||Compares odds ratio.|Generalized Estimating Equations|||||2.5|0.7|0.378
91670269|NCT05966090|183235401|NON_INFERIORITY|Non - Inferiority (NI) was to be demonstrated if the upper limit of the 2 sided 95% confidence interval (CI) of the GMC ratio between the Control group (at Day 91) versus Co-administration group (at Day 91) for anti-gE Ab 1-month after the second HZ/su vaccine dose was \<=1.5.|Ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed concentration, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate non-inferiority of the humoral immune response to 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with RSVPreF3 OA investigational vaccine, compared to 2 doses of HZ/su vaccine administered alone.||1.42|1.08|
91670270|NCT05966090|183235402|NON_INFERIORITY|NI was to be demonstrated if upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5|ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.35|0.97|
91670271|NCT05966090|183235403|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5.|ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.15|0.84|
91715174|NCT03191799|183321467|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
91636856|NCT03852901|183166147|OTHER|||||||0.024||||||Type III of fixed effects. Num df: 2; Den df = 34; F = 4.1501; Sig. = 0.0244 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effects: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age and fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.024
91636857|NCT01409382|183166159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|1.5|7.6|||Chi-squared|||Take home babies||7.6|1.5|<0.05
91636858|NCT04120116|183166252|SUPERIORITY||Odds Ratio (OR)|0.3||||0.068|TWO_SIDED|95.0|0.11|1.08||P value for statistical significance is \<0.05|Mixed Models Analysis|||||1.08|0.11|0.068
91636859|NCT04120116|183166254|SUPERIORITY||Least squares mean difference|1.25|STANDARD_ERROR_OF_MEAN|2.611||0.634|TWO_SIDED|95.0|-3.945|6.439||P value for statistical significance is \<0.05|Mixed Models Analysis|||||6.439|-3.945|0.634
91636860|NCT01098266|183166280|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.58|TWO_SIDED|95.0|0.75|1.18||The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.|Log Rank|Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.||Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05||1.18|0.75|0.58
91636861|NCT01098266|183166281|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.78|1.17|||Log Rank|Cox regression analyses (unstratified and stratified) was performed to assess the influence of baseline covariates in an exploratory manner.||The log-rank test (unstratified and stratified) was used at an alpha level of 5% to test for differences in PFS between the two treatment arms. Kaplan-Meier curves and estimates were provided.||1.17|0.78|0.65
91636862|NCT01098266|183166282|SUPERIORITY||Odds Ratio (OR)|1.13||||0.62|TWO_SIDED|95.0|0.76|1.68|||Fisher Exact||Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner|Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.||1.68|0.76|0.62
91670272|NCT01077817|183235442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.||1.5|0.7|
91670273|NCT01077817|183235442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.||2.0|0.9|
91670274|NCT01077817|183235442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.9|||||TWO_SIDED|95.0|1.4|16.7|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.||16.7|1.4|
91670275|NCT01077817|183235442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|1.0|2.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.||2.5|1.0|
91670276|NCT01077817|183235442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.2|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.||2.2|0.2|
91670277|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||1.3|0.7|
91670278|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.8|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.8|
91670279|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.5|3.4|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate~compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||3.4|0.5|
91670280|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate~compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.9|
91485231|NCT02437383|182843671|SUPERIORITY||LSM Difference (Final Values)|-1.8||||0.414|TWO_SIDED|95.0|-6.2|2.6||P-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|Covariates for site, baseline value, sex, race, treatment, visit, a treatment\*visit interaction, and an unstructured covariance structure.||||2.6|-6.2|0.414
91670281|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.3|0.3|
91670282|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.5|0.7|
91670283|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|1.9|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.9|0.7|
91670284|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.0|||||TWO_SIDED|95.0|0.8|11.1|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||11.1|0.8|
91670285|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8|||||TWO_SIDED|95.0|1.1|3.0|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||3.0|1.1|
91715175|NCT03191799|183321467|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
91715176|NCT03191799|183321467|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
91715177|NCT03191799|183321467|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
91636863|NCT01098266|183166285|OTHER|Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.|Hazard Ratio (HR)|0.92||||0.5806|TWO_SIDED|95.0|0.68|1.26|||Log Rank|||QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.||1.26|0.68|0.5806
91636864|NCT01733758|183166287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.55|||||TWO_SIDED|95.0|-1.72|-1.39|||ANCOVA|||||-1.39|-1.72|
91636865|NCT01733758|183166287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.35|||||TWO_SIDED|95.0|-1.51|-1.18|||ANCOVA|||||-1.18|-1.51|
91636866|NCT01733758|183166287|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.||||||<0.0001
91636867|NCT01733758|183166287|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.||||||<0.0001
91670286|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.1|2.7|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||2.7|0.1|
91636868|NCT00727246|183166323|OTHER|||||||0.85|TWO_SIDED|95.0|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. A mean index score created as a composite cognitive performance across domains (higher t-score = higher cognition). Purpose was to serve as a measure of overall cognitive functioning for data analysis.||||.85
91636869|NCT00727246|183166324|OTHER|||||||0.329|TWO_SIDED|0.95|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo.||||.329
91636870|NCT00661362|183166325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.55|-0.29|||ANCOVA|||||-0.29|-0.55|<0.0001
91636871|NCT00661362|183166326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.149|<|0.0002|TWO_SIDED|95.0|-0.85|-0.26|||ANCOVA|||||-0.26|-0.85|<0.0002
91636872|NCT00661362|183166327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.1|STANDARD_ERROR_OF_MEAN|2.684|<|0.0002|TWO_SIDED|95.0|-15.37|-4.83|||ANCOVA|||||-4.83|-15.37|<0.0002
91636873|NCT00661362|183166328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-155.0|STANDARD_ERROR_OF_MEAN|55.0||0.0052|TWO_SIDED|95.0|-264.0|-47.0|||ANCOVA|||||-47|-264|0.0052
91636874|NCT00661362|183166329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2802.0|STANDARD_ERROR_OF_MEAN|989.8||0.0052|TWO_SIDED|95.0|-4753.0|-852.0|||ANCOVA|||||-852|-4753|0.0052
91636875|NCT00661362|183166330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.1|||<|0.0001|TWO_SIDED|95.0|8.0|24.0|||ANCOVA|||||24.0|8.0|<0.0001
91636876|NCT03970330|183166390|SUPERIORITY||Mean Difference (Final Values)|1123.0||||0.2|TWO_SIDED|95.0|-755.0|3000.0|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||3000|-755|0.20
91636877|NCT03970330|183166391|SUPERIORITY||Mean Difference (Final Values)|28.9||||0.06|TWO_SIDED|95.0|-1.9|59.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at BASELINE||59.6|-1.9|0.06
91636878|NCT03970330|183166391|SUPERIORITY||Mean Difference (Final Values)|10.4||||0.48|TWO_SIDED|95.0|-20.3|41.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 4||41.2|-20.3|0.48
91636879|NCT03970330|183166391|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.21|TWO_SIDED|95.0|-11.8|49.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 8||49.6|-11.8|0.21
91636880|NCT03970330|183166391|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.3|TWO_SIDED|95.0|-15.2|46.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 12||46.2|-15.2|0.30
91715178|NCT03191799|183321477|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
91715179|NCT03191799|183321477|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
91715180|NCT03191799|183321477|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
91715181|NCT03191799|183321477|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
91670287|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.6|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||1.6|0.5|
91670288|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.|Proportional hazards regression model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.0|0.6|
91670289|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.4|2.5|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate~compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.5|0.4|
91715182|NCT03191799|183321477|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
91715183|NCT03191799|183321478|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
91715184|NCT03191799|183321478|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
91636881|NCT03970330|183166391|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.65|TWO_SIDED|95.0|-24.0|37.5|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 16||37.5|-24.0|0.65
91636882|NCT03970330|183166392|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.07
91636883|NCT03970330|183166392|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.07
91636884|NCT03970330|183166392|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.06
91636885|NCT03970330|183166392|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||1.00
91636886|NCT03970330|183166393|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Comparison of treament groups at WEEK 4||||0.29
91636887|NCT03970330|183166393|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.24
91636888|NCT03970330|183166393|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.20
91636889|NCT03970330|183166393|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.53
91636890|NCT03970330|183166394|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.37
91636891|NCT03970330|183166394|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.39
91636892|NCT03970330|183166394|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.37
91636893|NCT03970330|183166394|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.39
91636894|NCT03970330|183166395|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.08|TWO_SIDED|95.0|-0.6|9.2|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||9.2|-0.6|0.08
91636895|NCT02500706|183166433|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|-0.02|||<|0.001|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|<0.001
91636896|NCT02500706|183166433|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|0.1|||<|0.001|TWO_SIDED|95.0|0.004|0.19||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.19|0.004|<0.001
91636897|NCT02500706|183166433|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points."|Treatment difference|-0.02||||0.633|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|0.633
91636898|NCT02500706|183166434|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.~Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0."|Treatment difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.36|-0.45||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA|||Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.||-0.45|-1.36|<0.001
91636899|NCT02500706|183166435|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0."|Treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.31|0.34||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.||0.34|-0.31|0.924
91636900|NCT04269629|183166508|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACEI) and the group without such treatment. The primary outcome was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.25||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||It was assumed that 24% of the patients would be on β-blockers and/or ACE inhibitors (ACEI). A χ2 test with a two-sided 5% significance level has an 80% power to detect the difference between the group without antihypertensive medication with 6% SR during VIT and the group on β-blockers and/or ACEI with 12.3% SR during VIT (OR = 2.2) when the sample sizes are 631 and 200, respectively. A drop-out rate of 37% was assumed which resulted in a required number of 1,319 patients.||||0.25
91636901|NCT04269629|183166509|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.29||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.29
91636902|NCT04269629|183166510|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.04||||||The level of significance was set at 0.05. Correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions (p=0.04).|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.||||0.04
91670290|NCT01077817|183235443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|3.9|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||3.9|0.2|
91527848|NCT06173570|182930692|SUPERIORITY||Mean Difference (Net)|-2.31||||0.292|TWO_SIDED|95.0|-6.62|1.99|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||1.99|-6.62|0.292
91636903|NCT04269629|183166511|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.|||||<|0.001||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||<0.001
91670291|NCT01386125|183235444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.14||||0.0007|TWO_SIDED|95.0|-0.22|-0.06|||ANCOVA|||||-0.06|-0.22|0.0007
91670292|NCT01386125|183235445|SUPERIORITY_OR_OTHER_LEGACY||Difference is LS Means|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Constrained longitudinal data analysis|||||-0.15|-0.45|<0.0001
91670293|NCT01098539|183235446|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test to test whether the difference of LS means (albiglutide - sitagliptin) was less than or equal to the prespecified noninferiority margin of 0.4%.|Median Difference (Final Values)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.49|-0.15|||t-test, 1 sided|||||-0.15|-0.49|<0.0001
91715185|NCT03191799|183321478|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
91715186|NCT03191799|183321478|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
91715187|NCT03191799|183321478|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
91715188|NCT01239797|183321482|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0014|TWO_SIDED|95.0|0.6|0.89|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.89|0.60|0.0014
91636904|NCT04269629|183166512|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.99||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - bee venom.||||0.99
91636905|NCT04269629|183166512|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.15||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - vespid venom.||||0.15
91636906|NCT04269629|183166513|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.16||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.16
91670294|NCT00108550|183235565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0305|STANDARD_ERROR_OF_MEAN|0.038||0.4237|TWO_SIDED|95.0|-0.044|0.105||There was no need for multiple comparisons adjustment for the primary outcome, since there was only one. However, secondary analyses were adjusted for multiple comparisons.|Mixed Models Analysis|Effect of covariates (age, gender, etc) was evaluated (modeled as fixed effects) in secondary analyses.|The analysis was performed on transformed (rather than raw) Descriptor Differential Score Pain Intensity scores.|The null hypothesis was that Gabapentin is no better than placebo in reducing back pain. A mean-matching variance stabilizing transformation was applied to Descriptor Differential Scale Pain intensity (DDS) scores. Scores were modeled as a function of time (week) and group (gabapentin, placebo) in a mixed effects model. Random (subject-specific)intercept and slopes were fitted to the data. With alpha = .05 and N = 65 per group power is .8 to detect effect size =.4 standard deviations (SD).||0.105|-0.044|0.4237
91670295|NCT00108550|183235566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5343|STANDARD_ERROR_OF_MEAN|0.7174||0.458|TWO_SIDED|95.0|-1.94|0.872||Primary analyses was multivariable linear regression with fixed and random effects. After the Bonferroni adjustment a p-value would have been considered significant at 0.05 level if \<0.01.|Mixed Models Analysis|||This is a secondary analysis; the null hypothesis is that Gabapentin performs no better than placebo in reducing the Roland and Morris score.||0.872|-1.940|0.458
91670296|NCT03222037|183235593|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.5|-0.09|-0.02|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for high lumniance low contrast|Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.||-0.02|-0.09|
91670297|NCT03222037|183235593|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05|Median Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|97.5|-0.06|-0.01|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for denominator degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for Low luminance high contrast|||-0.01|-0.06|
91670298|NCT03222037|183235594|EQUIVALENCE|Statistical significance is declared if the lower limit of the 95% confidence interval is above 0 or if the upper limit of the 95% confidence interval is below 0.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0066|TWO_SIDED|95.0|0.01|0.08|||Linear Mixed Model|Linear Mixed Model with Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - SCR.|Comparison between the Test and SCR treatments was carried out using least-square mean differences||0.08|0.01|0.0066
91715189|NCT01239797|183321483|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0005|TWO_SIDED|95.0|0.6|0.87|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.87|0.60|0.0005
91636907|NCT04269629|183166514|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.5||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.50
91636908|NCT04269629|183166515|OTHER|||||||0.72||||||The level of significance was set at 0.05.|Fisher Exact|||||||0.72
91670299|NCT04974580|183235595|SUPERIORITY||Odds Ratio (OR)|1.3||||0.14|TWO_SIDED|95.0|0.91|1.84||A priori threshold was 0.10|Regression, Logistic||Reported OR is NRT receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving NRT.|Comparison of NRT vs. no-NRT in model adjusted for receipt of digital component||1.84|0.91|0.14
91670300|NCT04974580|183235595|SUPERIORITY||Odds Ratio (OR)|1.04||||0.84|TWO_SIDED|95.0|0.73|1.47||A priori threshold was 0.10|Regression, Logistic||Reported OR is Digital receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving the Digital component.|Comparison of Digital vs. no Digital in model adjusted for receipt of NRT component||1.47|0.73|0.84
91670301|NCT04511208|183235757|SUPERIORITY||Difference in means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.7|-1.7|||Repeated measures linear model|||||-1.7|-2.7|<0.001
91670302|NCT04511208|183235758|SUPERIORITY||Difference in means|-0.26||||0.006|TWO_SIDED|95.0|-0.44|-0.08|||Repeated measures linear model|||||-0.08|-0.44|0.006
91670303|NCT04511208|183235759|SUPERIORITY||Difference in means|-0.23||||0.046|TWO_SIDED|95.0|-0.45|-0.005|||Repeated measures linear model|||||-0.005|-0.45|0.046
91670304|NCT04511208|183235760|SUPERIORITY||Difference in means|-0.07||||0.955|TWO_SIDED|95.0|-2.51|2.38|||Repeated measures linear model|||C3B PST Score||2.38|-2.51|0.955
91670305|NCT04511208|183235760|SUPERIORITY||Difference in means|0.62||||0.686|TWO_SIDED|95.0|-2.48|3.71|||Repeated measures linear model|||C3B VMT Score||3.71|-2.48|0.686
91670306|NCT04511208|183235761|SUPERIORITY||Odds Ratio (OR)|2.5||||0.007|TWO_SIDED|95.0|1.28|4.68|||Generalized linear mixed effects model|||||4.68|1.28|0.007
91670307|NCT04511208|183235761|SUPERIORITY||Difference in means|-1.1||||0.009|TWO_SIDED|95.0|-1.82|-0.28|||Repeated measures linear model|||Sensitivity analysis||-0.28|-1.82|0.009
91670308|NCT04511208|183235762|SUPERIORITY||Difference in means|-1.06||||0.004|TWO_SIDED|95.0|-1.75|-0.38|||Repeated measures linear model|||||-0.38|-1.75|0.004
91670309|NCT04511208|183235763|SUPERIORITY||Difference in means|-2.97|||<|0.001|TWO_SIDED|95.0|-3.8|-2.13|||Repeated measures linear model|||||-2.13|-3.80|<0.001
91670310|NCT00987831|183235768|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|30.0||||0.2738|TWO_SIDED|95.0|5.0|95.0||Definition of Moderate Disease was \</= 3 BILAG B (moderate) organ scores, no A (severe) scores and SLEDAI \</=10. Severe disease was \> 3 BILAG B or \>/= BILAG A or SLEDAI \> 10 or meets definition for severe flare on the SELENA SLEDAI Flare Index|Log Rank|||||95|5|0.2738
91715190|NCT01239797|183321484|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0002|TWO_SIDED|95.0|1.36|2.78|||Cochran-Mantel-Haenszel|Stratified by B2 microglobulin (\<3.5 mg/L vs \>=3.5 mg/L), number of prior lines of therapy (1 vs \>=2), and immunomodulatory drug use at randomization||Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||2.78|1.36|0.0002
91715191|NCT01239797|183321484|SUPERIORITY||Difference in ORR|12.7|||||TWO_SIDED|95.0|6.2|19.3||||||Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)||19.3|6.2|
91670311|NCT02413294|183235778|SUPERIORITY|||||||0.37||||||This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.|Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.37
91670312|NCT02413294|183235779|SUPERIORITY|||||||0.42|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.42
91670313|NCT02413294|183235780|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.65
91670314|NCT02413294|183235781|SUPERIORITY|||||||1|||||||Fisher Exact|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||1.0
91670315|NCT02413294|183235782|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
91670316|NCT02413294|183235783|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
91670317|NCT02413294|183235784|SUPERIORITY|||||||0.94|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.94
91485232|NCT04010539|182843748|NON_INFERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.|Adjusted Difference in Percent|-0.1|||||TWO_SIDED|95.0|-5.6|5.5||||||||5.5|-5.6|
91670318|NCT02413294|183235785|SUPERIORITY|||||||0.81|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.81
91670319|NCT02413294|183235786|SUPERIORITY|||||||0.4|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.40
91485233|NCT04010539|182843748|SUPERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Superiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above 0.0%.|Adjusted Difference in Percent|-0.1||||0.5072|TWO_SIDED|95.0|-5.6|5.5|||1-sided p-value for Test of Superiority|||||5.5|-5.6|0.5072
91670320|NCT02413294|183235787|SUPERIORITY|||||||0.46|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.46
91670321|NCT02413294|183235788|SUPERIORITY||||||<|0.01|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||<0.01
91670322|NCT02413294|183235789|SUPERIORITY|||||||0.28|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.28
91670323|NCT02413294|183235790|SUPERIORITY|||||||0.67|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.67
91670324|NCT02413294|183235791|SUPERIORITY|||||||0.56|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.56
91670325|NCT02413294|183235792|SUPERIORITY|||||||0.82|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.82
91670326|NCT02625974|183235793|OTHER|A direct comparison|Difference in cure rate|14.0|||||TWO_SIDED|95.0|3.7|24.2||||||||24.2|3.7|
91670327|NCT02625974|183235794|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.12|||||TWO_SIDED|95.0|1.21|3.45|||||Person-year = 754|||3.45|1.21|
91636909|NCT04269629|183166516|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.11||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent SR under VIT.||||0.11
91636910|NCT01000311|183166517|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|83.0|||||TWO_SIDED|95.0|83.0|93.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.||93|83|
91636911|NCT01000311|183166517|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|90.0|||||TWO_SIDED|95.0|90.0|98.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.||98|90|
91636912|NCT01000311|183166517|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|93.0|||||TWO_SIDED|95.0|93.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup W.||99|93|
91636913|NCT01000311|183166517|SUPERIORITY_OR_OTHER||Lowe limit of 95% confidence interval|92.0|||||TWO_SIDED|95.0|92.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup Y.||99|92|
91636914|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to diphtheria toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.9|2.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||2.6|-2.9|
91636915|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to tetanus toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-3.3|3.9|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||3.9|-3.3|
91636916|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-12.1|4.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone||4.3|-12.1|
91670328|NCT02625974|183235799|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|0.91|4.16|||||Person-year = 379|||4.16|0.91|
91670329|NCT03941834|183235835|OTHER||Least square (LS) mean difference|0.7|||||TWO_SIDED|95.0|0.1|1.2||||||Analysis were performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.2|0.1|
91670330|NCT03941834|183235840|OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-6.8|11.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline Penn-FPS-R as a covariate; and participant as a random effect.||11.5|-6.8|
91670331|NCT03941834|183235841|OTHER||LS Mean Difference|1.5|||||TWO_SIDED|95.0|-3.8|6.9||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline pain disability index as a covariate; and participant as a random effect.||6.9|-3.8|
91670332|NCT03941834|183235842|OTHER||LS Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.7|0.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; and participant as a random effect.||0.5|-0.7|
91636917|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis (FHA antigen), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|4.0|||||TWO_SIDED|95.0|-5.1|13.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||13.6|-5.1|
91670333|NCT03941834|183235843|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|0.1|1.4||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.4|0.1|
91670334|NCT03941834|183235844|OTHER||Odds Ratio (OR)|12.6|||||TWO_SIDED|95.0|0.7|229.6||||||Analysis was performed using a logistic regression model, including fixed effects for treatment, sequence, period and baseline NPRS score as a covariate.||229.6|0.7|
91670335|NCT01316419|183235898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean SBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
91670336|NCT01316419|183235901|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean DBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
91670337|NCT01316419|183235903|SUPERIORITY_OR_OTHER|||||||0.1099|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.1099
91670338|NCT01316419|183235904|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0197
91485234|NCT02314143|182843776|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.224|4.459|||Cochran-Mantel-Haenszel||The odds ratio for dabrafenib followed by combination therapy versus combination therapy has been presented.|||4.459|0.224|1.0000
91636918|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis pertactin antigen, when DTaP vaccine is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-8.8|9.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.||9.1|-8.8|
91636919|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-2.0|||||TWO_SIDED|95.0|-10.6|6.8|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||6.8|-10.6|
91670339|NCT01316419|183235905|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.4543
91670340|NCT01316419|183235906|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0152
91670341|NCT01316419|183235907|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0013
91636920|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to hepatitis B, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of hepatitis B vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-5.2|4.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.||4.5|-5.2|
91636921|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to Hib vaccine, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of Hib vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|5.0|||||TWO_SIDED|95.0|0.0|11.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.||11.2|0|
91670342|NCT01316419|183235908|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The change of QOL data collected using the EQ VAS is analyzed by paired t-test|Paired t test|||||||<0.0001
91670343|NCT01316419|183235910|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.0006
91670344|NCT01316419|183235911|SUPERIORITY_OR_OTHER|||||||0.4248|TWO_SIDED|||||Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.4248
91670345|NCT01316419|183235912|SUPERIORITY_OR_OTHER|||||||0.5579|TWO_SIDED|||||Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.5579
91670346|NCT01316419|183235913|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test|Paired t-test|||||||0.0006
91670347|NCT00412737|183235924|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.283||||0.772|TWO_SIDED|95.0|-2.3|4.1|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.||4.1|-2.3|0.772
91670348|NCT00412737|183235925|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.37||||0.534|TWO_SIDED|95.0|-2.1|4.5|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.5|-2.1|0.534
91670349|NCT00412737|183235926|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.431||||0.381|TWO_SIDED|95.0|-1.7|4.6|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.7|0.381
91670350|NCT00412737|183235927|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.713|||||TWO_SIDED|95.0|-0.6|5.2|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.2|-0.6|
91670351|NCT00412737|183235928|SUPERIORITY_OR_OTHER||Slope|0.858|||||TWO_SIDED|95.0|0.1|5.7|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.7|0.1|
91670352|NCT00412737|183235929|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.372|||||TWO_SIDED|95.0|-1.9|4.6|||||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.9|
91670353|NCT00412737|183235930|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.502|||||TWO_SIDED|95.0|-1.4|5.1|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.1|-1.4|
91670354|NCT03244475|183235932|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.|Mean Difference (Final Values)|1.6||||0.01|TWO_SIDED|95.0|1.1|2.2||The corrected p-value of 0.01 was chosen after the standard cluster analysis for correcting family-wise error across different voxels.|Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||The analysis was performed for the voxel-wise delta-band activity from the frontal pole and inferior frontal gyri. Spatial smoothing and logarithm transformation (e-based) were performed. Resting-state MEG activity differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||2.2|1.1|0.01
91670355|NCT03244475|183235933|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91485235|NCT02314143|182843776|OTHER||Odds Ratio (OR)|1.97||||0.4216|TWO_SIDED|95.0|0.382|10.166|||Cochran-Mantel-Haenszel||The odds ratio for trametinib followed by combination therapy versus combination therapy has been presented.|||10.166|0.382|0.4216
91715192|NCT02631941|183321494|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|100.64|||<|0.001|TWO_SIDED|90.0|95.82|105.69|||Mixed Models Analysis|||||105.69|95.82|<0.001
91670356|NCT03244475|183235934|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91715193|NCT02631941|183321494|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|102.11|||<|0.001|TWO_SIDED|90.0|95.55|109.13|||Mixed Models Analysis|||||109.13|95.55|<0.001
91715194|NCT02631941|183321495|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|87.96||||0.002|TWO_SIDED|90.0|83.31|92.86|||Mixed Models Analysis|||||92.86|83.31|0.002
91715195|NCT02631941|183321495|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|91.17||||0.005|TWO_SIDED|90.0|83.94|99.04|||Mixed Models Analysis|||||99.04|83.94|0.005
91715196|NCT02631941|183321496|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|157.86||||1|TWO_SIDED|90.0|144.12|172.91|||Mixed Models Analysis|||||172.91|144.12|1.00
91636922|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 1), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-3.1|5.4|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||5.4|-3.1|
91636923|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 2), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.4|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||3|-1.4|
91636924|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 3), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|-1.0|||||TWO_SIDED|95.0|-3.3|1.7|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||1.7|-3.3|
91636925|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||4.6|-1.9|
91636926|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-10.3|3.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.2|-10.3|
91636927|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-8.7|2.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||2.3|-8.7|
91485236|NCT03194503|182843795|SUPERIORITY||Odds Ratio (OR)|0.65||||0.015|TWO_SIDED|95.0|0.47|0.92|||t-test, 2 sided|||This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||0.92|0.47|0.015
91636928|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.8|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.0|-2.8|
91670357|NCT03244475|183235935|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91636929|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-7.3|1.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||1.6|-7.3|
91670358|NCT03244475|183235936|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670359|NCT03244475|183235937|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91636930|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|3.0|||||TWO_SIDED|95.0|1.3|7.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||7.1|1.3|
91636931|NCT01000311|183166521|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-5.0|||||TWO_SIDED|95.0|-11.4|0.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||0.5|-11.4|
91636932|NCT01000311|183166522|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.02|||||TWO_SIDED|95.0|0.81|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone||1.28|0.81|
91636933|NCT01000311|183166522|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FHA antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.9|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.19|0.9|
91636934|NCT01000311|183166522|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis pertactin antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.28|0.84|
91636935|NCT01000311|183166522|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.88|1.35|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.35|0.88|
91636936|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.8|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.19|0.8|
91636937|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.76|||||TWO_SIDED|95.0|0.62|0.93|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||0.93|0.62|
91636938|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.06|0.72|
91670360|NCT03244475|183235938|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670361|NCT03244475|183235939|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670362|NCT03244475|183235940|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670363|NCT03244475|183235941|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670364|NCT03244475|183235942|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670365|NCT03244475|183235943|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
91670366|NCT02285634|183235957|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
91636939|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.28|0.84|
91636940|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.2|0.82|
91636941|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.89|||||TWO_SIDED|95.0|0.73|1.07|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.07|0.73|
91636942|NCT01000311|183166523|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.84|||||TWO_SIDED|95.0|0.68|1.04|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.04|0.68|
91670367|NCT02285634|183235957|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
91670368|NCT02285634|183235957|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
91670369|NCT02285634|183235958|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
91485237|NCT03194503|182843796|SUPERIORITY||Odds Ratio (OR)|0.77||||0.25|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided|||This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||1.20|0.50|0.250
91670370|NCT02285634|183235958|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
91670371|NCT02285634|183235958|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
91670372|NCT02285634|183235959|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
91485238|NCT00457366|182843797|OTHER|We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.|||||>|0.05|||||||ANCOVA|||||||>0.05
91485239|NCT04231318|182843798|SUPERIORITY|||||||0.0406|||||||ANOVA|||||||0.0406
91670373|NCT02285634|183235959|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
91670374|NCT02285634|183235959|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
91670375|NCT02285634|183235960|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
91670376|NCT02285634|183235960|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
91670377|NCT02285634|183235960|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
91636943|NCT03091920|183166552|OTHER|No statistical testing was performed.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-14.2|12.4|||||LS mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1 postdose AM 1 hour||12.4|-14.2|
91715197|NCT02631941|183321496|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|166.81||||1|TWO_SIDED|90.0|148.35|187.57|||Mixed Models Analysis|||||187.57|148.35|1.00
91485240|NCT04231318|182843798|SUPERIORITY|||||||0.0795|||||||ANOVA|||||||0.0795
91485241|NCT04231318|182843798|SUPERIORITY|||||||0.7601|||||||ANOVA|||||||0.7601
91636944|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|0.6|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-11.8|12.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 1 hour||12.9|-11.8|
91636945|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-13.9|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-30.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||2.8|-30.6|
91636946|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-15.5|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-31.0|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||0|-31.0|
91636947|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-23.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||3.9|-23.8|
91636948|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-16.0|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||9.7|-16.0|
91636949|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.2|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||8.6|-26.2|
91636950|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-19.7|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||12.6|-19.7|
91636951|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-18.7|12.2||||||Day 1 postdose PM 1 hour||12.2|-18.7|
91636952|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|95.0|-18.7|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose PM||9.9|-18.7|
91636953|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-18.2|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||1.3|-18.2|
91636954|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-14.8|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||3.3|-14.8|
91636955|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-15.4|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-28.1|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||-2.8|-28.1|
91636956|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-21.1|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||2.3|-21.1|
91636957|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-25.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||7.9|-25.6|
91636958|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.2|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-26.7|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||4.4|-26.7|
91636959|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-24.0|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||0.6|-24.0|
91636960|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.4|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||4.4|-18.4|
91636961|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-13.0|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||16.2|-13.0|
91636962|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|-12.9|14.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||14.2|-12.9|
91636963|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-16.4|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.1|-16.4|
91670378|NCT01049412|183235973|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.81|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.81|<0.001
91670379|NCT01049412|183235974|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.56|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.83|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.83|<0.001
91670380|NCT01049412|183235975|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.242|TWO_SIDED|90.0|-0.28|0.05||The statistical significance level is 0.10.|Mixed Models Analysis|||||0.05|-0.28|0.242
91670381|NCT01049412|183235976|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.276
91670382|NCT01049412|183235976|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.119
91670383|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.3|STANDARD_ERROR_OF_MEAN|0.35||0.392|TWO_SIDED|90.0|-0.28|0.88||"The statistical significance level is 0.10.~P-value is for 0300 hour BG."|Mixed Models Analysis|||||0.88|-0.28|0.392
91670384|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.24|STANDARD_ERROR_OF_MEAN|0.33||0.464|TWO_SIDED|90.0|-0.79|0.3||"The statistical significance level is 0.10.~P-value is for morning FBG."|Mixed Models Analysis|||||0.30|-0.79|0.464
91715198|NCT02631941|183321497|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|85.22||||0.012|TWO_SIDED|90.0|79.66|91.17|||Mixed Models Analysis|||||91.17|79.66|0.012
91636964|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-13.9|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.9|-13.9|
91670385|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.48|STANDARD_ERROR_OF_MEAN|0.33||0.151|TWO_SIDED|90.0|-1.04|0.07||"The statistical significance level is 0.10.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis|||||0.07|-1.04|0.151
91670386|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.54|STANDARD_ERROR_OF_MEAN|0.3||0.079|TWO_SIDED|90.0|-1.05|-0.03||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis|||||-0.03|-1.05|0.079
91670387|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.52|STANDARD_ERROR_OF_MEAN|0.28||0.07|TWO_SIDED|90.0|-0.99|-0.05||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis|||||-0.05|-0.99|0.070
91715199|NCT02631941|183321497|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|87.74||||0.02|TWO_SIDED|90.0|81.48|94.47|||Mixed Models Analysis|||||94.47|81.48|0.020
91485242|NCT04231318|182843799|SUPERIORITY|||||||0.1942|||||||ANOVA|||||||0.1942
91670388|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.86|STANDARD_ERROR_OF_MEAN|0.32||0.008|TWO_SIDED|90.0|-1.39|-0.34||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG."|Mixed Models Analysis|||||-0.34|-1.39|0.008
91670389|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.89|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|90.0|-1.38|-0.41||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis|||||-0.41|-1.38|0.003
91670390|NCT01049412|183235978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-1.1|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|90.0|-1.64|-0.55||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis|||||-0.55|-1.64|0.001
91670391|NCT01049412|183235983|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.037
91670392|NCT01049412|183235984|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|90.0|-0.69|-0.25||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.25|-0.69|<0.001
91670393|NCT01142908|183235989|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.93|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||3.1|-2.8|0.93
91670394|NCT01142908|183235990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4||||0.34|TWO_SIDED|95.0|-1.5|4.3|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||4.3|-1.5|0.34
91670395|NCT01142908|183235992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.91|TWO_SIDED|95.0|-2.0|1.8|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||1.8|-2.0|0.91
91715200|NCT00731822|183321515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|||||TWO_SIDED|95.0|-3.9|5.1||||||||5.1|-3.9|
91485243|NCT04231318|182843799|SUPERIORITY|||||||0.0957|||||||ANOVA|||||||0.0957
91636965|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-15.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||6.4|-15.8|
91636966|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-16.0|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||4.5|-16.0|
91670396|NCT01142908|183235993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||2.2|-1.5|0.70
91670397|NCT01142908|183235994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.9|0.3|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-3.9|0.1
91670398|NCT01142908|183235995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.74|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||1.7|-2.4|0.74
91670399|NCT01142908|183235997|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|-0.03||||0.87|TWO_SIDED|95.0|-0.4|0.3|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-0.4|0.87
91670400|NCT01142908|183235998|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|0.2||||0.36|TWO_SIDED|95.0|-0.2|0.5|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.5|-0.2|0.36
91670401|NCT01142908|183236000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.9||||0.08|TWO_SIDED|95.0|-10.3|0.6|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.6|-10.3|0.08
91670402|NCT01142908|183236001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.8||||0.79|TWO_SIDED|95.0|-6.6|5.0|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||5.0|-6.6|0.79
91670403|NCT01142908|183236003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.02||||0.83|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.2|0.83
91670404|NCT01142908|183236004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.54|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.2|-0.4|0.54
91485244|NCT04231318|182843799|SUPERIORITY|||||||0.4526|||||||ANOVA|||||||0.4526
91670405|NCT01142908|183236006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.29|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.6|0.29
91670406|NCT01142908|183236007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.72|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||0.4|-0.5|0.72
91670407|NCT03235479|183236011|SUPERIORITY||Risk Difference (RD)|4.9||||0.0298|TWO_SIDED|95.0|0.5|9.3|||Cochran-Mantel-Haenszel|||||9.3|0.5|0.0298
91670408|NCT03235479|183236012|SUPERIORITY||Risk Difference (RD)|8.9||||0.0016|TWO_SIDED|95.0|3.4|14.4|||Cochran-Mantel-Haenszel|||||14.4|3.4|0.0016
91670409|NCT03235479|183236013|SUPERIORITY||Risk Difference (RD)|10.2||||0.0005|TWO_SIDED|95.0|4.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|4.4|0.0005
91670410|NCT03235479|183236014|SUPERIORITY||Risk Difference (RD)|7.7||||0.0299|TWO_SIDED|95.0|0.8|14.6|||Cochran-Mantel-Haenszel|||||14.6|0.8|0.0299
91670411|NCT03235479|183236015|SUPERIORITY||Risk Difference (RD)|10.3||||0.0006|TWO_SIDED|95.0|4.4|16.2|||Cochran-Mantel-Haenszel|||||16.2|4.4|0.0006
91670412|NCT03235479|183236016|SUPERIORITY||Risk Difference (RD)|5.2||||0.1815|TWO_SIDED|95.0|-2.4|12.9||P-value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.9|-2.4|0.1815
91670413|NCT03110380|183236027|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|-0.7|||||TWO_SIDED|95.001|-2.8|1.0|||||The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.||1.0|-2.8|
91670414|NCT03110380|183236027|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
91670415|NCT03110380|183236028|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group -DTG+F/TAF group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|2.2|||||TWO_SIDED|95.001|-2.3|6.8|||||The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.8|-2.3|
91670416|NCT03110380|183236029|SUPERIORITY||Difference in LSM|-18.0||||0.23|TWO_SIDED|95.0|-46.0|11.0|||ANOVA|P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.||||11|-46|0.23
91485245|NCT04231318|182843800|SUPERIORITY|||||||0.1309|||||||ANOVA|||||||0.1309
91485246|NCT04231318|182843800|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.1700
91485247|NCT04231318|182843800|SUPERIORITY|||||||0.7609|||||||ANOVA|||||||0.7609
91636967|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-13.6|13.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||13.1|-13.6|
91636968|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-15.2|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||9.6|-15.2|
91636969|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-15.5|3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||3.0|-15.5|
91636970|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|-16.6|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||0.5|-16.6|
91636971|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-11.8|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||8.4|-11.8|
91636972|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-10.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-19.4|-0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||-0.7|-19.4|
91636973|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.1|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||4.7|-18.1|
91636974|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-14.8|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||6.3|-14.8|
91636975|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.2|14.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||14.1|-12.2|
91692151|NCT01262872|183279149|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.6|||||TWO_SIDED|95.0|-18.2|26.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||26.2|-18.2|
91715201|NCT04073303|183321519|SUPERIORITY||Rate-Difference|49.0|||<|0.0001|TWO_SIDED|95.0|40.1|54.1|||Cochran-Mantel-Haenszel|||||54.1|40.1|<0.0001
91715202|NCT04073303|183321520|SUPERIORITY||Rate-Difference|71.2|||<|0.0001|TWO_SIDED|95.0|60.7|76.3|||Cochran-Mantel-Haenszel|||||76.3|60.7|<0.0001
91485248|NCT04231318|182843801|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.1000
91485249|NCT04231318|182843801|SUPERIORITY|||||||0.0423|||||||ANOVA|||||||0.0423
91636976|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-16.0|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||8.4|-16.0|
91636977|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|-15.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||9.1|-15.1|
91636978|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-6.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||4.8|-17.6|
91636979|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-9.5|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-22.7|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||3.7|-22.7|
91636980|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-17.2|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-29.5|-5.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||-5.0|-29.5|
91636981|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-24.4|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||1.1|-24.4|
91636982|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-20.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||3.5|-20.2|
91715203|NCT04073303|183321521|SUPERIORITY||Rate-Difference|56.7|||<|0.0001|TWO_SIDED|95.0|45.6|64.5|||Cochran-Mantel-Haenszel|||||64.5|45.6|<0.0001
91670417|NCT00452543|183236031|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.|||||<|0.05||95.0||||Threshold for significance was set a priori at p\<0.05.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
91670418|NCT00452543|183236032|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo.|||||<|0.05||95.0||||This p \<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
91670419|NCT00452543|183236033|NON_INFERIORITY_OR_EQUIVALENCE|"This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis is discussed above."|||||<|0.05||95.0||||This p\<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||"Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups."||||<0.05
91670420|NCT02795676|183236045|NON_INFERIORITY|Non-inferiority was to be declared if the lower bound of the confidence interval for the treatment difference is above the non-inferiority margin, which was met. No p-value was calculated as this is not relevant for non-inferiority.|Median Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-2.444|1.726|||Regression, Linear|The primary efficacy analysis compared eGFR slope between the treatment arms using a 2-stage model with quantile regression.||||1.726|-2.444|
91670421|NCT01201486|183236053|SUPERIORITY_OR_OTHER||Percentage Sensitivity|23.0|||||TWO_SIDED||||||Percentage Sensitivity|||||||
91670422|NCT00496262|183236105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9|STANDARD_DEVIATION|4.4|<|0.0001||90.0|||||2-sided, 1-sample t-test||The entire ITT population was used for a conservative analysis of the mean change in MCF. The mean change was set to 0 for any subject with missing MCF data.|This is an open-label study with statistical comparison between MCF pre-infusion and 1 hour post-infusion.||||<0.0001
91670423|NCT02010996|183236118|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||0.05
91670424|NCT04381481|183236119|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
91670425|NCT04381481|183236120|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||snacks with warning compared to control snack||||<0.001
91715204|NCT04073303|183321522|SUPERIORITY||Rate-Difference|49.7|||<|0.0001|TWO_SIDED|95.0|40.6|57.4|||Cochran-Mantel-Haenszel|||||57.4|40.6|<0.0001
91485250|NCT04231318|182843801|SUPERIORITY|||||||0.383|||||||ANOVA|||||||0.3830
91485251|NCT04231318|182843802|SUPERIORITY|||||||0.0298|||||||ANOVA|||||||0.0298
91485252|NCT04231318|182843802|SUPERIORITY|||||||0.0217|||||||ANOVA|||||||0.0217
91485253|NCT04231318|182843802|SUPERIORITY|||||||0.4451|||||||ANOVA|||||||0.4451
91485254|NCT04231318|182843803|SUPERIORITY|||||||0.1197|||||||ANOVA|||||||0.1197
91485255|NCT04231318|182843803|SUPERIORITY|||||||0.0008|||||||ANOVA|||||||0.0008
91485256|NCT04231318|182843803|SUPERIORITY|||||||0.0223|||||||ANOVA|||||||0.0223
91670426|NCT04381481|183236121|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
91670427|NCT04381481|183236122|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
91670428|NCT04381481|183236123|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||Beverages with claim compared to control beverage||||<0.01
91670429|NCT04381481|183236124|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91670430|NCT04381481|183236125|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91670431|NCT04381481|183236126|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91670432|NCT04381481|183236127|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91670433|NCT04381481|183236128|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.01
91670434|NCT04381481|183236129|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.01
91715205|NCT04073303|183321523|SUPERIORITY||Rate-Difference|70.5|||<|0.0001|TWO_SIDED|95.0|59.6|77.5|||Cochran-Mantel-Haenszel|||||77.5|59.6|<0.0001
91636983|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-13.4|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-28.1|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||1.4|-28.1|
91636984|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-10.3|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-24.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||3.3|-24.0|
91636985|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-10.1|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-27.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||6.9|-27.0|
91636986|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|7.6|||TWO_SIDED|95.0|-20.4|11.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||11.1|-20.4|
91636987|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.2|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-19.5|11.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||11.0|-19.5|
91636988|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-15.4|12.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||12.8|-15.4|
91636989|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-23.0|-2.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||-2.5|-23.0|
91636990|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-5.2|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-14.7|4.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||4.3|-14.7|
91636991|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-19.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose AM||2.9|-19.0|
91636992|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-14.0|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose||6.3|-14.0|
91485257|NCT04231318|182843804|SUPERIORITY|||||||0.1067|||||||ANOVA|||||||0.1067
91636993|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-16.1|STANDARD_ERROR_OF_MEAN|7.2|||TWO_SIDED|95.0|-31.0|-1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||-1.2|-31.0|
91636994|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-22.1|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||5.6|-22.1|
91715206|NCT04073303|183321524|SUPERIORITY||LS Mean of Difference|-5.19|||<|0.0001|TWO_SIDED|95.0|-5.64|-4.75|||ANCOVA|||||-4.75|-5.64|<0.0001
91485258|NCT04231318|182843805|SUPERIORITY|||||||0.1715|||||||ANOVA|||||||0.1715
91636995|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||7.9|-14.6|
91636996|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-15.9|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||4.9|-15.9|
91636997|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.9|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-22.1|-1.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||-1.7|-22.1|
91636998|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-16.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||2.9|-16.0|
91636999|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-14.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-25.4|-3.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-3.2|-25.4|
91637000|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-22.1|-1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-1.5|-22.1|
91637001|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-29.0|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||5.6|-29.0|
91637002|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-9.8|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-25.9|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||6.2|-25.9|
91670435|NCT04381481|183236130|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91670436|NCT04381481|183236131|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91485259|NCT04231318|182843805|SUPERIORITY|||||||0.0736|||||||ANOVA|||||||0.0736
91637003|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-11.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-22.4|-0.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose PM||-0.1|-22.4|
91637004|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-20.2|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose PM||0.4|-20.2|
91637005|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-22.0|10.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||10.5|-22.0|
91637006|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-21.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||9.0|-21.1|
91637007|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-21.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||5.6|-21.7|
91637008|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-17.7|7.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||7.6|-17.7|
91637009|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.0|16.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.7|-7.0|
91637010|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-5.8|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.2|-5.8|
91637011|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|5.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-11.7|22.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||22.6|-11.7|
91637012|NCT03091920|183166552|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-20.4|11.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||11.4|-20.4|
91637013|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.9|3.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||3.8|-8.9|
91637014|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.4|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||4.5|-8.4|
91485260|NCT04231318|182843805|SUPERIORITY|||||||0.4098|||||||ANOVA|||||||0.4098
91637015|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.2|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||3.4|-9.2|
91637016|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.5|-0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||-0.6|-13.5|
91637017|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.5|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||0.6|-11.5|
91637018|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||1.5|-10.8|
91637019|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-9.4|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||2.2|-9.4|
91637020|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||3.7|-8.0|
91637021|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-13.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||3.9|-13.8|
91637022|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-11.7|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||6.2|-11.7|
91670437|NCT04381481|183236132|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
91485261|NCT04231318|182843806|SUPERIORITY|||||||0.2718|||||||ANOVA|||||||0.2718
91485262|NCT04231318|182843806|SUPERIORITY|||||||0.0182|||||||ANOVA|||||||0.0182
91637023|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||0.9|-9.7|
91637024|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-8.5|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||2.2|-8.5|
91637025|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.1|-0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||-0.3|-13.1|
91637026|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-11.8|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||1.2|-11.8|
91637027|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||3.5|-14.2|
91637028|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-17.5|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||0.5|-17.5|
91637029|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.6|0.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||0.2|-11.6|
91637030|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-10.6|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||1.5|-10.6|
91637031|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.4|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||6.4|-7.4|
91637032|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.3|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||4.7|-9.3|
91485263|NCT04231318|182843806|SUPERIORITY|||||||0.1131|||||||ANOVA|||||||0.1131
91637033|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.4|4.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||4.6|-9.4|
91637034|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-8.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||5.6|-8.7|
91485264|NCT04231318|182843807|SUPERIORITY|||||||0.2143|||||||ANOVA|||||||0.2143
91637035|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.7|-6.2|
91637036|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.8|-6.2|
91637037|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.4|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.4|-6.4|
91637038|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.3|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||6.8|-9.3|
91637039|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.0|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.4|-10.0|
91637040|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.3|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.3|-10.3|
91670438|NCT04381481|183236133|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91485265|NCT04231318|182843807|SUPERIORITY|||||||0.1628|||||||ANOVA|||||||0.1628
91485266|NCT04231318|182843807|SUPERIORITY|||||||0.6036|||||||ANOVA|||||||0.6036
91637041|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.2|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||3.3|-8.2|
91670439|NCT04381481|183236134|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670440|NCT04381481|183236135|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670441|NCT04381481|183236136|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670442|NCT04381481|183236137|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670443|NCT04381481|183236138|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670444|NCT04381481|183236139|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91637042|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-13.0|-1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||-1.3|-13.0|
91637043|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-7.7|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||2.2|-7.7|
91637044|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-9.7|0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||0.3|-9.7|
91637045|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.1|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-11.6|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.5|-11.6|
91670445|NCT04381481|183236140|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670446|NCT04381481|183236141|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670447|NCT04381481|183236142|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91637046|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-12.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.3|-12.0|
91637047|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.6|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||1.9|-10.6|
91637048|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-12.0|0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||0.7|-12.0|
91637049|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.3|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||10.3|-8.3|
91670448|NCT04381481|183236143|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670449|NCT04381481|183236144|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670450|NCT04381481|183236145|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670451|NCT04381481|183236146|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
91670452|NCT00476593|183236152|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|95.0||||Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.|t-test, 2 sided|The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender||Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group||||0.018
91670453|NCT00476593|183236152|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||t-test, 2 sided|||Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.||||0.024
91670454|NCT00559364|183236184|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) model using treatment group and pooled site as fixed effects and wash-out phase CFA% value as covariate was used.||||<0.0001
91670455|NCT01235442|183236206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.46|2.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI(=\<35 or \>35) and prior anti-TNF exposure(Yes or no).||||2.87|1.46|<0.001
91670456|NCT01235442|183236207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.4|2.75||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.75|1.40|<0.001
91670457|NCT01235442|183236208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.009|TWO_SIDED|95.0|1.21|2.64||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.64|1.21|0.009
91670458|NCT01235442|183236209|SUPERIORITY_OR_OTHER|||||||0.006||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No) with with modified ridit scores.||||||0.006
91670459|NCT01235442|183236210|SUPERIORITY_OR_OTHER||||||<|0.001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|van Elteren test|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||||<0.001
91670460|NCT01235442|183236211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.135|TWO_SIDED|95.0|0.92|1.85||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is adjusted for baseline BMI (=\<35 or \>35) and prior anti-TNF (Yes or No).||||1.85|0.92|0.135
91670461|NCT01235442|183236212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.135|TWO_SIDED|95.0|0.96|1.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||1.87|0.96|0.135
91670462|NCT02663882|183236233|SUPERIORITY|||||||0.503||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.503
91670463|NCT02663882|183236234|SUPERIORITY|||||||0.765||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.765
91670464|NCT02663882|183236235|SUPERIORITY|||||||0.717||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.717
91670465|NCT02663882|183236236|SUPERIORITY|||||||0.302||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.302
91670466|NCT03712124|183236237|OTHER||Least Square (LS) Mean Difference|-6.44||||0.903|TWO_SIDED|95.0|-116.18|103.31|||ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with change from baseline at Day 14 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||103.31|-116.18|0.9030
91670467|NCT03712124|183236238|OTHER||LS Mean Difference|98.45||||0.0042|TWO_SIDED|95.0|35.81|161.08|||ANCOVA|||Analysis was performed using ANCOVA model with change from baseline at Day 28 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||161.08|35.81|0.0042
91670468|NCT03581188|183236280|SUPERIORITY||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|14.0||||||Odds ratios report differences between groups at follow-up.||14|0.9|
91670469|NCT03581188|183236281|SUPERIORITY||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.8|5.7||||||||5.7|0.8|
91670470|NCT03581188|183236283|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|1.1|2.1||||||||2.1|1.1|
91670471|NCT03581188|183236284|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||||||||2|0.6|
91670472|NCT03581188|183236285|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-2.0|23.0||||||For new melanoma diagnoses, we calculated the difference in proportions and confidence intervals using the χ2 method without continuity correction. We included baseline measurement of the outcome in the models as a covariate to estimate between group difference in change from baseline.||23|-2|
91670473|NCT03581188|183236286|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|2.0|19.0||||||New melanoma diagnoses prompted at unscheduled visit||19|2|
91670474|NCT03581188|183236286|SUPERIORITY||Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|-9.0|10.0||||||New melanoma diagnoses prompted at scheduled visit||10|-9|
91670475|NCT03581188|183236287|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.8|3.0||||||||3|-5.8|
91670476|NCT00109837|183236299|SUPERIORITY_OR_OTHER||Proportion in 1-year CCR|0.36|STANDARD_DEVIATION|0.06|||ONE_SIDED|95.0|0.25|||||||The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.|||0.25|
91670477|NCT01989676|183236301|EQUIVALENCE|The hypothesis to be tested in this study was that the risk ratio of ORR of PF-05280014 versus that of trastuzumab-EU by Week 25 (+/-14 days) was within a pre-specified margin of 0.80 to 1.25.|Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.842|1.049||||||Risk Ratio and associated 95% confidence interval (CI) are unstratified and based on the Miettinen and Nurminen method.||1.049|0.842|
91670478|NCT01989676|183236302|SUPERIORITY||Cox Proportional Hazard|1.0||||0.505|TWO_SIDED|95.0|0.8|1.26||1-sided log-rank test was used to compare the PFS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and estrogen receptor (ER) status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.26|0.80|0.505
91670479|NCT01989676|183236303|SUPERIORITY||Cox Proportional Hazard|0.92||||0.304|TWO_SIDED|95.0|0.67|1.27||1-sided log-rank test was used to compare the DOR distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.27|0.67|0.304
91670480|NCT01989676|183236304|SUPERIORITY||Cox Proportional Hazard|0.929||||0.339|TWO_SIDED|95.0|0.656|1.316||1-sided log-rank test was used to compare the OS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.316|0.656|0.339
91715207|NCT03143101|183321528|SUPERIORITY||Mean Difference (Net)|18.1||||0.006|TWO_SIDED|95.0|4.8|30.9||p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||30.9|4.8|0.006
91485267|NCT04231318|182843808|SUPERIORITY|||||||0.222|||||||ANOVA|||||||0.2220
91485268|NCT04231318|182843808|SUPERIORITY|||||||0.141|||||||ANOVA|||||||0.1410
91670481|NCT02190279|183236347|OTHER|||||||0.0033|||||||ANOVA|||At 1 hour post injection.||||0.0033
91670482|NCT02190279|183236347|OTHER|||||||0.012|||||||ANOVA|||At 2 hour post injection.||||0.012
91670483|NCT02190279|183236348|EQUIVALENCE|One way analysis variance.|||||<|0.05|||||||variance|||||||<0.05
91637050|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||9.7|-9.2|
91637051|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-11.5|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||2.3|-11.5|
91637052|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.9|4.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||4.2|-9.9|
91637053|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-9.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-15.5|-3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-3.0|-15.5|
91670484|NCT02688387|183236357|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0667|||||TWO_SIDED|90.0|0.9657|1.1784|||||X1 Vs R1, ambrisentan|||1.1784|0.9657|
91670485|NCT02688387|183236357|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0353|||||TWO_SIDED|90.0|0.9293|1.1534|||||X2 Vs R2, ambrisentan|||1.1534|0.9293|
91715208|NCT03143101|183321532|SUPERIORITY||Mean Difference (Net)|32.7|||<|0.001|TWO_SIDED|95.0|14.4|47.8||p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||47.8|14.4|<0.001
91485269|NCT04231318|182843808|SUPERIORITY|||||||0.5418|||||||ANOVA|||||||0.5418
91485270|NCT04231318|182843809|SUPERIORITY|||||||0.1619|||||||ANOVA|||||||0.1619
91485271|NCT04231318|182843809|SUPERIORITY|||||||0.1683|||||||ANOVA|||||||0.1683
91485272|NCT04231318|182843809|SUPERIORITY|||||||0.6969|||||||ANOVA|||||||0.6969
91485273|NCT04231318|182843810|SUPERIORITY|||||||0.0701|||||||ANOVA|||||||0.0701
91485274|NCT04231318|182843810|SUPERIORITY|||||||0.0925|||||||ANOVA|||||||0.0925
91485275|NCT04231318|182843810|SUPERIORITY|||||||0.6981|||||||ANOVA|||||||0.6981
91485276|NCT04231318|182843811|SUPERIORITY|||||||0.0275|||||||ANOVA|||||||0.0275
91485277|NCT04231318|182843811|SUPERIORITY|||||||0.1738|||||||ANOVA|||||||0.1738
91485278|NCT04231318|182843811|SUPERIORITY|||||||0.8364|||||||ANOVA|||||||0.8364
91485279|NCT04231318|182843812|SUPERIORITY|||||||0.2227|||||||ANOVA|||||||0.2227
91485280|NCT04231318|182843812|SUPERIORITY|||||||0.1114|||||||ANOVA|||||||0.1114
91485281|NCT04231318|182843812|SUPERIORITY|||||||0.4635|||||||ANOVA|||||||0.4635
91485282|NCT01916967|182843813|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.17|||<|0.001|TWO_SIDED|95.0|-1.69|-0.65|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in least squares (LS) means of Desloratadine 5 mg and Placebo||-0.65|-1.69|<0.001
91485283|NCT01916967|182843813|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.13|||<|0.001|TWO_SIDED|95.0|-1.66|-0.61|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in LS means of Desloratadine 10 mg and Placebo||-0.61|-1.66|<0.001
91485284|NCT02337738|182843833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0006|TWO_SIDED|95.0|-1.32|-0.364|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-0.364|-1.320|0.0006
91637054|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-14.6|-1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-1.9|-14.6|
91637055|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-12.6|2.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||2.0|-12.6|
91637056|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.7|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||6.1|-8.7|
91485285|NCT02337738|182843833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.07|-0.122|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 0.5mg and Placebo (TVP-1012 0.5mg - Placebo).|||-0.122|-1.070|0.0140
91485286|NCT01278160|182843876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-0.24|0.22|||ANCOVA|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate.||The null hypothesis is H0: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) = 0 against the alternative hypothesis HA: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) ≠ 0. This trial is an extension to BIAsp-3756 (NCT01123980), hence no particular sample size calculation was made.||0.22|-0.24|
91525985|NCT03502616|182927259|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.247|<|0.0001|TWO_SIDED|95.0|-2.2|-1.23|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.23|-2.20|<0.0001
91670486|NCT02688387|183236357|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9839|||||TWO_SIDED|90.0|0.9288|1.0423|||||X1 Vs R1, tadalafil|||1.0423|0.9288|
91670487|NCT02688387|183236357|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9656|||||TWO_SIDED|90.0|0.9151|1.0188|||||X2 Vs R2, tadalafil|||1.0188|0.9151|
91670488|NCT02688387|183236358|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.03|||||TWO_SIDED|90.0|0.9965|1.0646|||||X1 Vs R1, ambrisentan|||1.0646|0.9965|
91670489|NCT02688387|183236358|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0141|||||TWO_SIDED|90.0|0.982|1.0473|||||X2 Vs R2, ambrisentan|||1.0473|0.9820|
91670490|NCT02688387|183236358|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9693|||||TWO_SIDED|90.0|0.931|1.0092|||||X1 Vs R1, tadalafil|||1.0092|0.9310|
91670491|NCT02688387|183236358|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0157|||||TWO_SIDED|90.0|0.9553|1.0799|||||X2 Vs R2, tadalafil|||1.0799|0.9553|
91527849|NCT06173570|182930692|SUPERIORITY||Mean Difference (Net)|0.55||||0.802|TWO_SIDED|95.0|-3.76|4.86|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||4.86|-3.76|0.802
91670492|NCT02688387|183236359|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0278|||||TWO_SIDED|90.0|0.9943|1.0623|||||X1 Vs R1, ambrisentan|||1.0623|0.9943|
91670493|NCT02688387|183236359|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0144|||||TWO_SIDED|90.0|0.9832|1.0466|||||X2 Vs R2, ambrisentan|||1.0466|0.9832|
91670494|NCT02688387|183236359|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9612|||||TWO_SIDED|90.0|0.9265|0.9972|||||X1 Vs R1, tadalafil|||0.9972|0.9265|
91670495|NCT02688387|183236359|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0122|||||TWO_SIDED|90.0|0.9562|1.0715|||||X2 Vs R2, tadalafil|||1.0715|0.9562|
91670496|NCT02688387|183236360|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0153|||||TWO_SIDED|90.0|0.9348|1.1027|||||Y1 Vs R3, ambrisentan|||1.1027|0.9348|
91670497|NCT02688387|183236360|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9758|||||TWO_SIDED|90.0|0.9044|1.0529|||||Y1 Vs R3, tadalafil|||1.0529|0.9044|
91670498|NCT02688387|183236361|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.039|||||TWO_SIDED|90.0|1.0168|1.0617|||||Y1 Vs R3, ambrisentan|||1.0617|1.0168|
91670499|NCT02688387|183236361|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9806|||||TWO_SIDED|90.0|0.9106|1.056|||||Y1 Vs R3, tadalafil|||1.0560|0.9106|
91670500|NCT02688387|183236362|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0365|||||TWO_SIDED|90.0|1.0138|1.0596|||||Y1 Vs R3, ambrisentan|||1.0596|1.0138|
91670501|NCT02688387|183236362|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9821|||||TWO_SIDED|90.0|0.9145|1.0547|||||Y1 Vs R3, tadalafil|||1.0547|0.9145|
91670502|NCT02688387|183236363|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1176|||||TWO_SIDED|90.0|1.0166|1.2287|||||Y2 Vs R4, ambrisentan|||1.2287|1.0166|
91670503|NCT02688387|183236363|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1196|||||TWO_SIDED|90.0|1.0429|1.2019|||||Y2 Vs R4, tadalafil|||1.2019|1.0429|
91670504|NCT02688387|183236364|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0353|||||TWO_SIDED|90.0|1.0009|1.071|||||Y2 Vs R4, ambrisentan|||1.0710|1.0009|
91670505|NCT02688387|183236364|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0362|||||TWO_SIDED|90.0|0.991|1.0834|||||Y2 Vs R4, tadalafil|||1.0834|0.9910|
91670506|NCT02688387|183236365|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0351|||||TWO_SIDED|90.0|1.0002|1.0713|||||Y2 Vs R4, ambrisentan|||1.0713|1.0002|
91670507|NCT02688387|183236365|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0324|||||TWO_SIDED|90.0|0.9929|1.0734|||||Y2 Vs R4, tadalafil|||1.0734|0.9929|
91670508|NCT01115855|183236446|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.36||||||Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) covariates.||1.36|0.53|
91670509|NCT01115855|183236447|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.56|1.31||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.31|0.56|
91670510|NCT01115855|183236448|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.81|3.87||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.87|0.81|
91670511|NCT01115855|183236449|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.4|||||TWO_SIDED|95.0|0.92|6.24||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||6.24|0.92|
91670512|NCT01115855|183236450|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.44|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.44|
91722535|NCT02629159|183337901|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|24.1|||<|0.001|TWO_SIDED|95.0|19.4|28.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Placebo|||28.8|19.4|<0.001
91525986|NCT03502616|182927259|SUPERIORITY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.07|-1.05|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.05|-2.07|<0.0001
91670513|NCT01115855|183236451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.45|1.25||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.25|0.45|
91670514|NCT01115855|183236452|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.45|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.45|
91670515|NCT01115855|183236453|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.49|1.33||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>=-50 ml/min/1.73 m\^2) covariates.||1.33|0.49|
91670516|NCT01115855|183236454|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.45|1.1||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.10|0.45|
91670517|NCT01115855|183236455|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.53|1.28||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.28|0.53|
91670518|NCT01115855|183236456|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.18|3.53||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.53|0.18|
91670519|NCT01115855|183236457|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.07|17.85||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||17.85|0.07|
91670520|NCT01115855|183236458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11|||||TWO_SIDED|95.0|0.39|11.56||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||11.56|0.39|
91670521|NCT01115855|183236459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.66||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||5.66|0.05|
91670522|NCT01115855|183236460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.16|8.04||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||8.04|0.16|
91670523|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.93|STANDARD_ERROR_OF_MEAN|47.13|||TWO_SIDED|95.0|-195.92|-9.94||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-9.94|-195.92|
91670524|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-95.77|STANDARD_ERROR_OF_MEAN|44.54|||TWO_SIDED|95.0|-184.51|-7.04||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-7.04|-184.51|
91637057|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||6.7|-8.2|
91637058|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.3|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||7.9|-7.3|
91637059|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-10.3|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||0.6|-10.3|
91637060|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-7.7|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||3.4|-7.7|
91637061|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-3.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.0|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||2.3|-10.0|
91637062|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-11.4|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||1.2|-11.4|
91637063|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-8.7|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-15.2|-2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||-2.2|-15.2|
91637064|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-12.0|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||1.3|-12.0|
91670525|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-125.09|STANDARD_ERROR_OF_MEAN|35.15|||TWO_SIDED|95.0|-195.5|-54.68||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-54.68|-195.50|
91670526|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.94|STANDARD_ERROR_OF_MEAN|51.12|||TWO_SIDED|95.0|-232.77|-31.11||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-31.11|-232.77|
91722536|NCT02629159|183337901|SUPERIORITY||Response Rate Difference|10.4||||0.001|TWO_SIDED|95.0|4.2|16.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.7|4.2|0.001
91485287|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed models analysis|0.2||||0.2569||95.0|-0.15|0.56||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.56|-0.15|0.2569
91637065|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-7.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||2.8|-7.6|
91670527|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-132.39|STANDARD_ERROR_OF_MEAN|52.77|||TWO_SIDED|95.0|-240.94|-23.84||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-23.84|-240.94|
91637066|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||0.8|-9.7|
91637067|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||0.8|-10.7|
91637068|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.4|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||1.3|-10.4|
91637069|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-9.0|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.6|-3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-3.4|-14.6|
91637070|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.2|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-2.8|-14.2|
91670528|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-117.18|STANDARD_ERROR_OF_MEAN|51.76|||TWO_SIDED|95.0|-221.49|-12.87||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-12.87|-221.49|
91670529|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-101.5|STANDARD_ERROR_OF_MEAN|61.05|||TWO_SIDED|95.0|-267.36|64.36||||||Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.36|-267.36|
91670530|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-110.78|STANDARD_ERROR_OF_MEAN|92.42|||TWO_SIDED|95.0|-307.49|85.93||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||85.93|-307.49|
91637071|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-13.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.5|-13.8|
91637072|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-14.3|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.2|-14.3|
91637073|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-15.0|-1.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||-1.0|-15.0|
91637074|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-14.2|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||0|-14.2|
91637075|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||6.4|-9.8|
91637076|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.0|8.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||8.5|-8.0|
91637077|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||3.7|-9.0|
91637078|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-7.1|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||5.8|-7.1|
91637079|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-5.5|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||3.9|-5.5|
91637080|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-4.6|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||4.9|-4.6|
91637081|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-6.5|10.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.7|-6.5|
91637082|NCT03091920|183166553|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-7.9|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-7.9|
91637083|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|6.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-4.4|16.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||16.8|-4.4|
91637084|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|9.1|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-1.5|19.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||19.8|-1.5|
91637085|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-9.0|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||9.0|-9.0|
91637086|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-4.6|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||13.4|-4.6|
91670531|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-119.62|STANDARD_ERROR_OF_MEAN|158.84|||TWO_SIDED|95.0|-2137.82|1898.59||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1898.59|-2137.82|
91670532|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-144.6|STANDARD_ERROR_OF_MEAN|200.56|||TWO_SIDED|90.0|-2692.95|2403.76||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||2403.76|-2692.95|
91670533|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-77.26|STANDARD_ERROR_OF_MEAN|966.09|||TWO_SIDED|95.0|-2131.88|1977.37||||||Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1977.37|-2131.88|
91670534|NCT01115855|183236462|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.3|STANDARD_ERROR_OF_MEAN|35.67|||TWO_SIDED|95.0|-172.61|-32.0||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-32.00|-172.61|
91670535|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-364.65|STANDARD_ERROR_OF_MEAN|763.83|||TWO_SIDED|95.0|-1863.06|1133.76||||||Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1133.76|-1863.06|
91670536|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-247.14|STANDARD_ERROR_OF_MEAN|711.26|||TWO_SIDED|95.0|-1642.43|1148.14||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1148.14|-1642.43|
91670537|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-370.14|STANDARD_ERROR_OF_MEAN|699.58|||TWO_SIDED|95.0|-1742.51|1002.22||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1002.22|-1742.51|
91722537|NCT02629159|183337902|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-44.04|||<|0.001|TWO_SIDED|95.0|-55.39|-32.69||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-32.69|-55.39|<0.001
91525987|NCT03502616|182927259|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.281||0.0483|TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.11|0.0483
91637087|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-7.5|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||7.1|-7.5|
91670538|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-664.09|STANDARD_ERROR_OF_MEAN|11059.62|||TWO_SIDED|95.0|-141189.93|139861.75||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||139861.75|-141189.93|
91670539|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-414.99|STANDARD_ERROR_OF_MEAN|3071.77|||TWO_SIDED|95.0|-39445.52|38615.54||||||Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||38615.54|-39445.52|
91670540|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|23.86|STANDARD_ERROR_OF_MEAN|10794.85|||TWO_SIDED|95.0|-21649.89|21697.6||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21697.60|-21649.89|
91670541|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-245.23|STANDARD_ERROR_OF_MEAN|6698.57|||TWO_SIDED|95.0|-85358.69|84868.22||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||84868.22|-85358.69|
91637088|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.7|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||8.9|-5.7|
91715209|NCT03126786|183321557|SUPERIORITY|The sample size was determined such that the difference in visual acuity between the ACTIVE treatment group and CONTROL treatment group could be estimated within +/- five ETDRS letters. Week 24 data from the Eylea prescribing information was used to estimate a pooled standard deviation of 9.17 letters. With 28 subjects per arm, a two-sided 90% confidence interval with a distance from the mean difference to the limits (half of interval width) will be less than 5 letters.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.28||0.288|TWO_SIDED|90.0|-6.2|1.4||There was a single primary outcome tested at a single primary endpoint, therefore no adjustments for multiple comparisons were performed. The primary endpoint was assess with a 2-sided alpha level of 0.100.|Mixed model for repeat measures|The covariance structure was assumed to be unstructured.|Estimated Value calculated as Active minus Control.|The primary efficacy analysis comparing ACTIVE with CONTROL on the mean change from baseline (Visit 2, Day 0) BCVA at Week 12 was be performed using a Mixed Model for Repeated Measurements (MMRM). This model included treatment (ACTIVE or CONTROL), visit (Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20) and Visit 8 (Week 24), and the 2-way interactions of treatment and visit, and the BCVA baseline included as the covariate.||1.4|-6.2|0.288
91715210|NCT03243305|183321564|OTHER||Seven-cycle Pregnancy Percentage|13.65|||||TWO_SIDED|95.0|9.91|17.39|||Kaplan-Meier|||The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%||17.39|9.91|
91715211|NCT02689804|183321566|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91715212|NCT02689804|183321567|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91715213|NCT04552132|183321590|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
91715214|NCT04552132|183321591|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91715215|NCT04552132|183321592|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
91715216|NCT04552132|183321593|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91715217|NCT04552132|183321594|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
91715218|NCT04552132|183321595|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
91637089|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-2.0|12.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.1|-2.0|
91637090|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-1.8|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.3|-1.8|
91637091|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||9.6|-5.1|
91637092|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-6.0|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||8.7|-6.0|
91527850|NCT06173570|182930692|SUPERIORITY||Mean Difference (Net)|-0.94||||0.664|TWO_SIDED|95.0|-5.21|3.32|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||3.32|-5.21|0.664
91637093|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.9|-5.0|
91715219|NCT04552132|183321596|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91715220|NCT04552132|183321597|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91715221|NCT04552132|183321598|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
91715222|NCT04552132|183321599|SUPERIORITY|||||||0.4993|||||||Chi-squared|||||||.4993
91715223|NCT04552132|183321600|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
91715224|NCT04552132|183321601|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
91715225|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-14.5|||<|0.001|TWO_SIDED|95.0|-18.0|-11.0|||ANCOVA|||Bima 30mg/kg + Sema 2.4mg vs Placebo||-11.0|-18.0|<0.001
91715226|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-10.5|||<|0.001|TWO_SIDED|95.0|-14.0|-7.09|||ANCOVA|||Bima 30mg/kg + Sema 1.0mg vs Placebo||-7.09|-14.0|<0.001
91715227|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-11.0|||<|0.001|TWO_SIDED|95.0|-14.4|-7.55|||ANCOVA|||Bima 10mg/kg + Sema 2.4mg vs Placebo||-7.55|-14.4|<0.001
91715228|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-9.41|||<|0.001|TWO_SIDED|95.0|-12.9|-5.93|||ANCOVA|||Bima 10mg/kg + Sema 1.0mg vs Placebo||-5.93|-12.9|<.001
91715229|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-10.9|||<|0.001|TWO_SIDED|95.0|-14.4|-7.46|||ANCOVA|||Sema 2.4mg vs Placebo||-7.46|-14.4|<0.001
91715230|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.96|-2.94|||ANCOVA|||Sema 1.0mg vs Placebo||-2.94|-9.96|<0.001
91715231|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-5.94|||<|0.001|TWO_SIDED|95.0|-9.47|-2.41|||ANCOVA|||Bima 30mg/kg vs Placebo||-2.41|-9.47|<0.001
91715232|NCT05616013|183321619|SUPERIORITY||LS Mean Change difference|-2.68||||0.133|TWO_SIDED|95.0|-6.18|0.82|||ANCOVA|||Bima 10mg/kg vs Placebo||0.82|-6.18|0.133
91715233|NCT04391842|183321676|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91715234|NCT04391842|183321677|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91715235|NCT00810199|183321678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2055|TWO_SIDED|95.0|0.882|1.799||Cochran-Mantel-Haenszel test stratified by region and baseline DAS28 (≤5.5 and \>5.5).|Cochran-Mantel-Haenszel|||||1.799|0.882|0.2055
91715236|NCT00810199|183321678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.1894|TWO_SIDED|95.0|0.889|1.814||Logistic regression including treatment , region and baseline DAS28.|Regression, Logistic|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.||||1.814|0.889|0.1894
91525988|NCT03502616|182927259|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.286||0.0357|TWO_SIDED|95.0|-1.17|-0.04|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.17|0.0357
91637094|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.3|6.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.6|-5.3|
91637095|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-8.1|13.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||13.2|-8.1|
91637096|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-6.3|15.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||15.0|-6.3|
91637097|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||11.2|-4.6|
91637098|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-1.0|14.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||14.9|-1.0|
91637099|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
91637100|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
91637101|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.5|-9.2|
91637102|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.5|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.2|-9.5|
91637103|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-5.1|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||7.4|-5.1|
91637104|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-3.4|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||9.2|-3.4|
91637105|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.5|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||4.8|-7.5|
91637106|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.5|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||5.8|-6.5|
91637107|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-9.9|5.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||5.3|-9.9|
91637108|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|9.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.8|-5.4|
91637109|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||13.7|0.2|
91637110|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-1.7|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||11.8|-1.7|
91637111|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||9.0|-3.1|
91637112|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.4|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||8.7|-3.4|
91637113|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|10.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||10.0|-5.4|
91715237|NCT00810199|183321679|SUPERIORITY_OR_OTHER|||||||0.8742||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8742
91637114|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.4|7.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||7.0|-8.4|
91637115|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.6|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.8|-1.6|
91637116|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.7|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.7|-1.7|
91637117|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-1.6|20.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||20.2|-1.6|
91637118|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|13.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|2.1|23.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||23.9|2.1|
91637119|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|7.1|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||13.9|0.2|
91637120|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|11.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|4.6|18.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||18.3|4.6|
91637121|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-4.8|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||8.6|-4.8|
91637122|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|4.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.6|10.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose||10.8|-2.6|
91637123|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|9.7|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.1|19.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.6|-0.1|
91637124|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|9.6|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.3|19.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.4|-0.3|
91637125|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|7.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.0|15.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||15.5|0|
91637126|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|8.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.6|16.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||16.1|0.6|
91637127|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.1|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.7|-5.1|
91637128|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|11.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.3|-5.4|
91637129|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-6.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.1|-6.1|
91637130|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.3|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.9|-5.3|
91637131|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-4.0|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||12.6|-4.0|
91637132|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-3.2|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||13.4|-3.2|
91637133|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-11.0|8.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.0|-11.0|
91670542|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|170.49|STANDARD_ERROR_OF_MEAN|10730.38|||TWO_SIDED|95.0|-21375.69|21716.66||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21716.66|-21375.69|
91637134|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-10.3|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.6|-10.3|
91637135|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-7.7|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||13.4|-7.7|
91637136|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-9.4|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||11.8|-9.4|
91637137|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.4|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||10.3|-8.4|
91637138|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.3|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||9.4|-9.3|
91637139|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-1.3|15.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||15.3|-1.3|
91670543|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-58.77|STANDARD_ERROR_OF_MEAN|12765.3|||TWO_SIDED|95.0|-30160.25|30042.7||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||30042.70|-30160.25|
91670544|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-212.25|STANDARD_ERROR_OF_MEAN|11073.11|||TWO_SIDED|90.0|-22723.82|22299.33||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||22299.33|-22723.82|
91670545|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|11486.21|||TWO_SIDED|95.0|-146026.28|145865.96||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||145865.96|-146026.28|
91670546|NCT01115855|183236463|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-187.72|STANDARD_ERROR_OF_MEAN|240.96|||TWO_SIDED|95.0|-662.67|287.23||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||287.23|-662.67|
91670547|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-0.55|3.96||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||3.96|-0.55|
91670548|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|95.0|0.07|5.42||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.42|0.07|
91670549|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.86|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|1.11|6.6||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.60|1.11|
91670550|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.86|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.81|7.9||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.90|1.81|
91670551|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|2.36|8.94||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.94|2.36|
91715238|NCT00810199|183321679|SUPERIORITY_OR_OTHER|||||||0.6212||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6212
91715239|NCT00810199|183321679|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.0963
91637140|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|9.9|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|1.6|18.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||18.2|1.6|
91637141|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|5.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.0|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||12.3|-1.0|
91670552|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|0.12|6.75||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.75|0.12|
91670553|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.06|7.25||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.25|-0.06|
91670554|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.65|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|0.86|8.44||||||Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.44|0.86|
91670555|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.85|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|0.02|7.68||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.68|0.02|
91670556|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|90.0|0.08|9.25||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||9.25|0.08|
91670557|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-1.82|10.07||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||10.07|-1.82|
91670558|NCT01115855|183236464|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|0.56|5.8||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.80|0.56|
91670559|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-61.53|STANDARD_ERROR_OF_MEAN|59.75|||TWO_SIDED|95.0|-186.44|63.37||||||Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||63.37|-186.44|
91670560|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.94|STANDARD_ERROR_OF_MEAN|54.2|||TWO_SIDED|95.0|-131.27|81.39||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||81.39|-131.27|
91670561|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.57|STANDARD_ERROR_OF_MEAN|43.18|||TWO_SIDED|95.0|-97.28|72.13||||||Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||72.13|-97.28|
91670562|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|72.78|||TWO_SIDED|95.0|-221.25|64.31||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.31|-221.25|
91670563|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-79.63|STANDARD_ERROR_OF_MEAN|67.42|||TWO_SIDED|95.0|-211.88|52.63||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||52.63|-211.88|
91670564|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|19.35|STANDARD_ERROR_OF_MEAN|88.95|||TWO_SIDED|95.0|-230.01|268.71||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||268.71|-230.01|
91670565|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.05|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|95.0|-194.21|152.11||||||Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||152.11|-194.21|
91670566|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.79|STANDARD_ERROR_OF_MEAN|79.91|||TWO_SIDED|95.0|-197.55|115.97||||||Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||115.97|-197.55|
91715240|NCT00810199|183321680|SUPERIORITY_OR_OTHER|||||||0.2969||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.2969
91715241|NCT00810199|183321680|SUPERIORITY_OR_OTHER|||||||0.2215||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.2215
91670567|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-44.48|STANDARD_ERROR_OF_MEAN|103.29|||TWO_SIDED|95.0|-247.11|158.15||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.15|-247.11|
91670568|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.69|STANDARD_ERROR_OF_MEAN|107.06|||TWO_SIDED|90.0|-238.31|182.93||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||182.93|-238.31|
91670569|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.46|STANDARD_ERROR_OF_MEAN|96.48|||TWO_SIDED|95.0|-221.17|158.24||||||Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.24|-221.17|
91670570|NCT01115855|183236465|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|28.85|||TWO_SIDED|95.0|-58.91|54.83||||||Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||54.83|-58.91|
91670571|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.21|0.37||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.37|-0.21|
91670572|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.34|0.3||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.30|-0.34|
91670573|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.27|0.39||||||Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.39|-0.27|
91670574|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.41|0.45||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.45|-0.41|
91715242|NCT00810199|183321680|SUPERIORITY_OR_OTHER|||||||0.1243||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.1243
91670575|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.56|0.24||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.24|-0.56|
91670576|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.55|0.25||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.25|-0.55|
91670577|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.49|0.31||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.31|-0.49|
91670578|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.44||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.44|-0.57|
91670579|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.5|0.54||||||Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.54|-0.50|
91715243|NCT00810199|183321681|SUPERIORITY_OR_OTHER|||||||0.6775||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.6775
91715244|NCT00810199|183321681|SUPERIORITY_OR_OTHER|||||||0.9976||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.9976
91715245|NCT00810199|183321681|SUPERIORITY_OR_OTHER|||||||0.2168||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2168
91715246|NCT00810199|183321682|SUPERIORITY_OR_OTHER|||||||0.8369||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8369
91637142|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|7.2|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|0.5|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||13.9|0.5|
91637143|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-8.4|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||7.4|-8.4|
91637144|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.0|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||9.9|-6.0|
91637145|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|3.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.0|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.8|-4.0|
91637146|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.2|-4.6|
91637147|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.0|7.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||7.3|-8.0|
91637148|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.2|8.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||8.1|-7.2|
91637149|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-11.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||10.2|-11.5|
91637150|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|6.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-4.1|17.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||17.5|-4.1|
91637151|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-9.1|
91637152|NCT03091920|183166554|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.2|-8.5|
91637153|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|3.07|||TWO_SIDED|95.0|-9.68|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.04|-9.68|
91637154|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-2.55|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.76|3.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.66|-8.76|
91637155|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-8.62|2.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.75|-8.62|
91637156|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-3.23|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-10.37|3.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||3.92|-10.37|
91637157|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|0.52|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-6.46|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.49|-6.46|
91637158|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-7.74|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||5.03|-7.74|
91637159|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-2.71|STANDARD_ERROR_OF_MEAN|4.21|||TWO_SIDED|95.0|-11.46|6.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.04|-11.46|
91637160|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-10.09|6.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.35|-10.09|
91637161|NCT03091920|183166559|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.67|||TWO_SIDED|95.0|-9.93|5.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||5.35|-9.93|
91637162|NCT03091920|183166560|OTHER|No statistical testing was performed.|Least squares mean difference|-7.06|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-14.52|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.40|-14.52|
91637163|NCT03091920|183166560|OTHER|No statistical testing was performed.|Least squares mean difference|-4.19|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-11.52|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.14|-11.52|
91637164|NCT03091920|183166560|OTHER|No statistical testing was performed.|Least squares mean difference|-3.82|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-11.47|3.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.83|-11.47|
91637165|NCT03091920|183166560|OTHER|No statistical testing was performed.|Least squares mean difference|1.42|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-6.1|8.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.94|-6.10|
91637166|NCT03091920|183166560|OTHER|No statistical testing was performed.|Least squares mean difference|-6.44|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-16.36|3.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||3.47|-16.36|
91670580|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.44|0.83||||||Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.83|-0.44|
91485288|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed models analysis|0.09||||0.812||95.0|-0.63|0.8||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.80|-0.63|0.8120
91485289|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|0.35||||0.2843||95.0|-0.29|0.99||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.99|-0.29|0.2843
91485290|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.4614||95.0|-0.5|1.11||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.11|-0.50|0.4614
91527851|NCT06173570|182930692|SUPERIORITY||Mean Difference (Net)|1.54||||0.481|TWO_SIDED|95.0|-2.74|5.82|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||5.82|-2.74|0.481
91637167|NCT03091920|183166560|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|95.0|-10.44|8.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||8.38|-10.44|
91637168|NCT03091920|183166561|OTHER|No statistical testing was performed.|Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-6.97|6.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.54|-6.97|
91637169|NCT03091920|183166561|OTHER|No statistical testing was performed.|Least squares mean difference|-1.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-8.24|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||5.03|-8.24|
91637170|NCT03091920|183166561|OTHER|No statistical testing was performed.|Least squares mean difference|-3.12|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.88|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||4.65|-10.88|
91637171|NCT03091920|183166561|OTHER|No statistical testing was performed.|Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-8.45|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||6.80|-8.45|
91637172|NCT03091920|183166561|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-7.84|9.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||9.58|-7.84|
91715247|NCT00810199|183321682|SUPERIORITY_OR_OTHER|||||||0.6528||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6528
91670581|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.63|0.89||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.89|-0.63|
91670582|NCT01115855|183236467|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11||||||Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.11|-0.36|
91715248|NCT00810199|183321682|SUPERIORITY_OR_OTHER|||||||0.2546||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2546
91715249|NCT00810199|183321683|SUPERIORITY_OR_OTHER|||||||0.1018|||||||Log Rank|||||||0.1018
91637173|NCT03091920|183166561|OTHER|No statistical testing was performed.|Least squares mean difference|-2.98|STANDARD_ERROR_OF_MEAN|3.96|||TWO_SIDED|95.0|-11.23|5.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.26|-11.23|
91637174|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|3.84|||TWO_SIDED|95.0|-13.51|2.41|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-13.51|
91637175|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-2.47|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|95.0|-10.41|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||5.47|-10.41|
91637176|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-8.05|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-17.36|1.25|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.25|-17.36|
91670583|NCT04100096|183236468|SUPERIORITY||Least Square (LS) Mean Difference|-1.02||||0.243|TWO_SIDED|95.0|-2.75|0.7||Comparison was carried out using MMRM, with study center (pooled), treatment group (TG), visit, ADT status, and TG by visit interaction (BVI), gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.70|-2.75|0.2430
91670584|NCT04100096|183236469|SUPERIORITY||LS Mean Difference|-0.04||||0.7759|TWO_SIDED|95.0|-0.35|0.27||Comparison was carried out using MMRM, with study center (pooled), TG, visit, ADT status, and TG BVI, gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.27|-0.35|0.7759
91670585|NCT04100096|183236470|SUPERIORITY||LS Mean Difference|-0.06||||0.6585|TWO_SIDED|95.0|-0.32|0.2||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 2||0.20|-0.32|0.6585
91715250|NCT00810199|183321684|SUPERIORITY_OR_OTHER|||||||0.7176|||||||Log Rank|||||||0.7176
91715251|NCT00810199|183321685|SUPERIORITY_OR_OTHER|||||||0.8526|||||||Log Rank|||||||0.8526
91715252|NCT00810199|183321686|SUPERIORITY_OR_OTHER|||||||0.2217|||||||Log Rank|||||||0.2217
91715253|NCT00810199|183321687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0008|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|Baseline DAS28 as a covariate.||||-0.11|-0.41|0.0008
91715254|NCT00810199|183321688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0245|TWO_SIDED|95.0|1.053|2.109|||Regression, Logistic|Logistic regression including treatment, region and baseline DAS28.|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.|||2.109|1.053|0.0245
91485291|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|0.44||||0.1591||95.0|-0.17|1.04||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.04|-0.17|0.1591
91637177|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-8.28|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-17.42|0.87|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.87|-17.42|
91637178|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-9.34|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-19.43|0.74|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.74|-19.43|
91637179|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-3.05|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-12.95|6.84|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||6.84|-12.95|
91715255|NCT00810199|183321688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.482||||0.0258||95.0|1.048|2.095||Stratified by region and baseline DAS28 (≤ 5.5 and \> 5.5).|Cochran-Mantel-Haenszel|||||2.095|1.048|0.0258
91715256|NCT00810199|183321689|SUPERIORITY_OR_OTHER|||||||0.0287||95.0|||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 24||||0.0287
91715257|NCT00810199|183321689|SUPERIORITY_OR_OTHER|||||||0.224|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 52||||0.2240
91715258|NCT00810199|183321690|SUPERIORITY_OR_OTHER|||||||0.0497||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.0497
91715259|NCT00810199|183321690|SUPERIORITY_OR_OTHER|||||||0.3918|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.3918
91715260|NCT00810199|183321691|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.0019
91525989|NCT03502616|182927259|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.278||0.0508|TWO_SIDED|95.0|-1.09|0.0|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.00|-1.09|0.0508
91525990|NCT03502616|182927259|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.282||0.0614|TWO_SIDED|95.0|-1.08|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-1.08|0.0614
91525991|NCT03502616|182927260|SUPERIORITY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.186|<|0.0001|TWO_SIDED|95.0|-1.26|-0.53|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.53|-1.26|<0.0001
91525992|NCT03502616|182927260|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.75|-0.92|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.92|-1.75|<0.0001
91525993|NCT03502616|182927260|SUPERIORITY||LS mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.41|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.41|<0.0001
91525994|NCT03502616|182927260|SUPERIORITY||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.37|<0.0001
91670586|NCT04100096|183236470|SUPERIORITY||LS Mean Difference|-0.25||||0.1181|TWO_SIDED|95.0|-0.57|0.06||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 4||0.06|-0.57|0.1181
91670587|NCT04100096|183236470|SUPERIORITY||LS Mean Difference|-0.19||||0.2431|TWO_SIDED|95.0|-0.51|0.13||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 6||0.13|-0.51|0.2431
91670588|NCT04100096|183236470|SUPERIORITY||LS Mean Difference|-0.3||||0.0638|TWO_SIDED|95.0|-0.61|0.02||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 8||0.02|-0.61|0.0638
91525995|NCT03502616|182927260|SUPERIORITY||LS mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-2.1|-1.14|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.14|-2.10|<0.0001
91525996|NCT03502616|182927260|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.261||0.0492|TWO_SIDED|95.0|-1.03|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.03|0.0492
91525997|NCT03502616|182927260|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.266||0.2614|TWO_SIDED|95.0|-0.82|0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.22|-0.82|0.2614
91525998|NCT03502616|182927260|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.272||0.0722|TWO_SIDED|95.0|-1.03|0.04|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.04|-1.03|0.0722
91525999|NCT03502616|182927260|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.275||0.0121|TWO_SIDED|95.0|-1.24|-0.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.15|-1.24|0.0121
91670589|NCT04100096|183236470|SUPERIORITY||LS Mean Difference|-0.11||||0.505|TWO_SIDED|95.0|-0.44|0.22||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 10||0.22|-0.44|0.5050
91715261|NCT00810199|183321691|SUPERIORITY_OR_OTHER|||||||0.1181|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.1181
91526000|NCT03502616|182927261|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.51|-1.33|<0.0001
91526001|NCT03502616|182927261|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.216|<|0.0001|TWO_SIDED|95.0|-2.02|-1.17|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.17|-2.02|<0.0001
91526002|NCT03502616|182927261|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-2.5|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.50|<0.0001
91526003|NCT03502616|182927261|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-2.5|-1.5|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.50|-2.50|<0.0001
91526004|NCT03502616|182927261|SUPERIORITY||LS mean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.35|-1.32|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.32|-2.35|<0.0001
91526005|NCT03502616|182927261|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.274||0.0785|TWO_SIDED|95.0|-1.02|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-1.02|0.0785
91526006|NCT03502616|182927261|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.3047|TWO_SIDED|95.0|-0.82|0.26|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.26|-0.82|0.3047
91526007|NCT03502616|182927261|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.283||0.1009|TWO_SIDED|95.0|-1.02|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-1.02|0.1009
91526008|NCT03502616|182927261|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.287||0.0764|TWO_SIDED|95.0|-1.08|0.05|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.05|-1.08|0.0764
91526009|NCT03502616|182927262|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.159||0.0089|TWO_SIDED|95.0|-0.73|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.73|0.0089
91526010|NCT03502616|182927262|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.179|<|0.0001|TWO_SIDED|95.0|-1.12|-0.42|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.12|<0.0001
91526011|NCT03502616|182927262|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.202|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.50|<0.0001
91670590|NCT04100096|183236470|SUPERIORITY||LS Mean Difference|-0.14||||0.4277|TWO_SIDED|95.0|-0.48|0.21||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 12||0.21|-0.48|0.4277
91670591|NCT04100096|183236471|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6225|TWO_SIDED|95.0|-0.18|0.3||Comparison between TGs was carried out using the Cochran-Mantel-Haenszel (CMH) Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.30|-0.18|0.6225
91670592|NCT04100096|183236471|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9145|TWO_SIDED|95.0|-0.35|0.31||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.31|-0.35|0.9145
91670593|NCT04100096|183236471|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.1535|TWO_SIDED|95.0|-0.52|0.08||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.08|-0.52|0.1535
91526012|NCT03502616|182927262|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.71|-0.88|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.88|-1.71|<0.0001
91526013|NCT03502616|182927262|SUPERIORITY||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.66|<0.0001
91526014|NCT03502616|182927262|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.242||0.1686|TWO_SIDED|95.0|-0.81|0.14|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.81|0.1686
91526015|NCT03502616|182927262|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.238||0.28|TWO_SIDED|95.0|-0.72|0.21|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.21|-0.72|0.2800
91526016|NCT03502616|182927262|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.243||0.1135|TWO_SIDED|95.0|-0.86|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.86|0.1135
91526017|NCT03502616|182927262|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.247||0.2496|TWO_SIDED|95.0|-0.77|0.2|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.20|-0.77|0.2496
91526018|NCT03502616|182927263|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-1.22|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.47|-1.22|<0.0001
91526019|NCT03502616|182927263|SUPERIORITY||LS mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.89|-1.07|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.07|-1.89|<0.0001
91526020|NCT03502616|182927263|SUPERIORITY||LS mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.228|<|0.0001|TWO_SIDED|95.0|-2.06|-1.16|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.16|-2.06|<0.0001
91526021|NCT03502616|182927263|SUPERIORITY||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-2.34|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.34|<0.0001
91526022|NCT03502616|182927263|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.236|<|0.0001|TWO_SIDED|95.0|-2.18|-1.25|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.25|-2.18|<0.0001
91526023|NCT03502616|182927263|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.245||0.0385|TWO_SIDED|95.0|-0.99|-0.03|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-0.99|0.0385
91526024|NCT03502616|182927263|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.0463|TWO_SIDED|95.0|-1.0|-0.01|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-1.00|0.0463
91526025|NCT03502616|182927263|SUPERIORITY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.257||0.0126|TWO_SIDED|95.0|-1.15|-0.14|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-1.15|0.0126
91637180|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-4.74|11.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||11.47|-4.74|
91637181|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|2.82|STANDARD_ERROR_OF_MEAN|3.82|||TWO_SIDED|95.0|-5.1|10.75|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.75|-5.10|
91670594|NCT04100096|183236471|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1922|TWO_SIDED|95.0|-0.5|0.1||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||0.10|-0.50|0.1922
91526026|NCT03502616|182927263|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.268||0.0372|TWO_SIDED|95.0|-1.09|-0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.09|0.0372
91526027|NCT03502616|182927264|SUPERIORITY||Difference in percentage|13.6|STANDARD_ERROR_OF_MEAN|3.53||0.0001|TWO_SIDED|95.0|6.68|20.52|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.52|6.68|0.0001
91526028|NCT03502616|182927264|SUPERIORITY||Difference in percentage|28.79|STANDARD_ERROR_OF_MEAN|4.6|<|0.0001|TWO_SIDED|95.0|19.78|37.8|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.80|19.78|<0.0001
91526029|NCT03502616|182927264|SUPERIORITY||Difference in percentage|33.31|STANDARD_ERROR_OF_MEAN|4.83|<|0.0001|TWO_SIDED|95.0|23.84|42.78|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.78|23.84|<0.0001
91526030|NCT03502616|182927264|SUPERIORITY||Difference in percentage|36.37|STANDARD_ERROR_OF_MEAN|4.95|<|0.0001|TWO_SIDED|95.0|26.67|46.07|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||46.07|26.67|<0.0001
91526031|NCT03502616|182927264|SUPERIORITY||Difference in percentage|36.34|STANDARD_ERROR_OF_MEAN|4.74|<|0.0001|TWO_SIDED|95.0|27.05|45.63|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.63|27.05|<0.0001
91526032|NCT03502616|182927264|SUPERIORITY||Difference in percentage|5.6|STANDARD_ERROR_OF_MEAN|5.99||0.3498|TWO_SIDED|95.0|-6.14|17.35|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.35|-6.14|0.3498
91526033|NCT03502616|182927264|SUPERIORITY||Difference in percentage|-2.4|STANDARD_ERROR_OF_MEAN|5.89||0.6835|TWO_SIDED|95.0|-13.96|9.15|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.15|-13.96|0.6835
91526034|NCT03502616|182927264|SUPERIORITY||Difference in percentage|-1.75|STANDARD_ERROR_OF_MEAN|5.98||0.7704|TWO_SIDED|95.0|-13.47|9.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.98|-13.47|0.7704
91526035|NCT03502616|182927264|SUPERIORITY||Difference in percentage|-1.13|STANDARD_ERROR_OF_MEAN|5.95||0.8492|TWO_SIDED|95.0|-12.8|10.53|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.53|-12.80|0.8492
91526036|NCT03502616|182927265|SUPERIORITY||Difference in percentage|2.24|STANDARD_ERROR_OF_MEAN|1.63||0.1692|TWO_SIDED|95.0|-0.95|5.43|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||5.43|-0.95|0.1692
91526037|NCT03502616|182927265|SUPERIORITY||Difference in percentage|4.46|STANDARD_ERROR_OF_MEAN|2.04||0.0289|TWO_SIDED|95.0|0.46|8.46|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.46|0.46|0.0289
91526038|NCT03502616|182927265|SUPERIORITY||Difference in percentage|6.02|STANDARD_ERROR_OF_MEAN|2.59||0.0199|TWO_SIDED|95.0|0.95|11.09|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.09|0.95|0.0199
91526039|NCT03502616|182927265|SUPERIORITY||Difference in percentage|12.03|STANDARD_ERROR_OF_MEAN|3.46||0.0005|TWO_SIDED|95.0|5.26|18.81|||Difference in percentage|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.81|5.26|0.0005
91526040|NCT03502616|182927265|SUPERIORITY||Difference in percentage|12.05|STANDARD_ERROR_OF_MEAN|3.45||0.0005|TWO_SIDED|95.0|5.29|18.8|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.80|5.29|0.0005
91637182|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.23|6.37|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.37|-15.23|
91526041|NCT03502616|182927265|SUPERIORITY||Difference in percentage|10.03|STANDARD_ERROR_OF_MEAN|4.49||0.0253|TWO_SIDED|95.0|1.24|18.83|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.83|1.24|0.0253
91526042|NCT03502616|182927265|SUPERIORITY||Difference in percentage|7.93|STANDARD_ERROR_OF_MEAN|4.75||0.095|TWO_SIDED|95.0|-1.38|17.24|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.24|-1.38|0.0950
91526043|NCT03502616|182927265|SUPERIORITY||Difference in percentage|7.21|STANDARD_ERROR_OF_MEAN|4.86||0.1377|TWO_SIDED|95.0|-2.31|16.73|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.73|-2.31|0.1377
91526044|NCT03502616|182927265|SUPERIORITY||Difference in percentage|5.68|STANDARD_ERROR_OF_MEAN|4.91||0.2472|TWO_SIDED|95.0|-3.94|15.3|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.30|-3.94|0.2472
91637183|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-4.85|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.65|5.94|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.94|-15.65|
91526045|NCT03502616|182927266|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|-1.05|-0.41|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.41|-1.05|<0.0001
91526046|NCT03502616|182927266|SUPERIORITY||LS mean difference|-1.28|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.65|-0.91|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.91|-1.65|<0.0001
91526047|NCT03502616|182927266|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.92|-1.09|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.09|-1.92|<0.0001
91526048|NCT03502616|182927266|SUPERIORITY||LS mean difference|-1.68|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.11|-1.24|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.24|-2.11|<0.0001
91526049|NCT03502616|182927266|SUPERIORITY||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.88|-1.0|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.00|-1.88|<0.0001
91526050|NCT03502616|182927266|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.235||0.088|TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-0.86|0.0880
91526051|NCT03502616|182927266|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.241||0.0921|TWO_SIDED|95.0|-0.88|0.07|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.88|0.0921
91526052|NCT03502616|182927266|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.243||0.0597|TWO_SIDED|95.0|-0.94|0.02|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.94|0.0597
91526053|NCT03502616|182927266|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0492|TWO_SIDED|95.0|-0.99|0.0|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-0.99|0.0492
91526054|NCT03502616|182927267|SUPERIORITY||Difference in percentage|8.31|STANDARD_ERROR_OF_MEAN|3.29||0.0116|TWO_SIDED|95.0|1.86|14.77|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.77|1.86|0.0116
91526055|NCT03502616|182927267|SUPERIORITY||Difference in percentage|22.74|STANDARD_ERROR_OF_MEAN|4.46|<|0.0001|TWO_SIDED|95.0|13.99|31.49|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.49|13.99|<0.0001
91526056|NCT03502616|182927267|SUPERIORITY||Difference in percentage|28.87|STANDARD_ERROR_OF_MEAN|4.99|<|0.0001|TWO_SIDED|95.0|19.09|38.66|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.66|19.09|<0.0001
91526057|NCT03502616|182927267|SUPERIORITY||Difference in percentage|31.93|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|22.28|41.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.58|22.28|<0.0001
91526058|NCT03502616|182927267|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|14.82|35.75|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||35.75|14.82|<0.0001
91637184|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-0.81|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-9.1|7.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||7.47|-9.10|
91637185|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-2.63|STANDARD_ERROR_OF_MEAN|3.76|||TWO_SIDED|95.0|-10.42|5.16|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.16|-10.42|
91526059|NCT03502616|182927267|SUPERIORITY||Difference in percentage|10.71|STANDARD_ERROR_OF_MEAN|5.88||0.0683|TWO_SIDED|95.0|-0.8|22.23|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.23|-0.80|0.0683
91637186|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-5.54|STANDARD_ERROR_OF_MEAN|3.98|||TWO_SIDED|95.0|-13.8|2.72|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.72|-13.80|
91637187|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-8.25|8.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||8.23|-8.25|
91670595|NCT04100096|183236471|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.6488|TWO_SIDED|95.0|-0.4|0.25||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.25|-0.40|0.6488
91670596|NCT04100096|183236471|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.5992|TWO_SIDED|95.0|-0.4|0.23||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||0.23|-0.40|0.5992
91670597|NCT04100096|183236472|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6579|TWO_SIDED|95.0|-0.29|0.19||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.19|-0.29|0.6579
91670598|NCT04100096|183236472|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3728|TWO_SIDED|95.0|-0.43|0.16||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.16|-0.43|0.3728
91670599|NCT04100096|183236472|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1684|TWO_SIDED|95.0|-0.5|0.09||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.09|-0.50|0.1684
91670600|NCT04100096|183236472|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.0046|TWO_SIDED|95.0|-0.74|-0.13||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||-0.13|-0.74|0.0046
91670601|NCT04100096|183236472|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2087|TWO_SIDED|95.0|-0.51|0.11||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.11|-0.51|0.2087
91670602|NCT04100096|183236472|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0389|TWO_SIDED|95.0|-0.64|-0.02||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||-0.02|-0.64|0.0389
91670603|NCT04100096|183236477|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.272|TWO_SIDED|95.0|-0.14|0.5||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 2||0.50|-0.14|0.2720
91526060|NCT03502616|182927267|SUPERIORITY||Difference in percentage|10.05|STANDARD_ERROR_OF_MEAN|5.94||0.0906|TWO_SIDED|95.0|-1.59|21.7|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||21.70|-1.59|0.0906
91670604|NCT04100096|183236477|SUPERIORITY||Mean Difference (Final Values)|1.09||||0|TWO_SIDED|95.0|0.63|1.56||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||1.56|0.63|0
91670605|NCT04100096|183236477|SUPERIORITY||Mean Difference (Final Values)|1.18||||0|TWO_SIDED|95.0|0.63|1.73||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||1.73|0.63|0
91670606|NCT04100096|183236477|SUPERIORITY||Mean Difference (Final Values)|1.57||||0|TWO_SIDED|95.0|0.92|2.21||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||2.21|0.92|0
91670607|NCT04100096|183236477|SUPERIORITY||Mean Difference (Final Values)|1.72||||0|TWO_SIDED|95.0|0.99|2.45||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||2.45|0.99|0
91670608|NCT04100096|183236477|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.0002|TWO_SIDED|95.0|0.68|2.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||2.19|0.68|0.0002
91670609|NCT04100096|183236478|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.062|TWO_SIDED|95.0|-0.07|2.68|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 12||2.68|-0.07|0.0620
91670610|NCT04100096|183236479|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.4613|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 2||0.17|-0.08|0.4613
91670611|NCT04100096|183236479|SUPERIORITY||Mean Difference (Final Values)|0.38||||0|TWO_SIDED|95.0|0.21|0.55||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||0.55|0.21|0
91670612|NCT04100096|183236479|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0001|TWO_SIDED|95.0|0.21|0.61||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.61|0.21|0.0001
91670613|NCT04100096|183236479|SUPERIORITY||Mean Difference (Final Values)|0.56||||0|TWO_SIDED|95.0|0.33|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||0.80|0.33|0
91670614|NCT04100096|183236479|SUPERIORITY||Mean Difference (Final Values)|0.61||||0|TWO_SIDED|95.0|0.34|0.88||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||0.88|0.34|0
91670615|NCT04100096|183236479|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.0004|TWO_SIDED|95.0|0.23|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.80|0.23|0.0004
91670616|NCT04100096|183236481|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1687|TWO_SIDED|95.0|-0.04|0.25||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.25|-0.04|0.1687
91670617|NCT04100096|183236481|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.1874|TWO_SIDED|95.0|-0.06|0.29||Analysis of covariance (ANCOVA) model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.29|-0.06|0.1874
91670618|NCT04100096|183236482|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.0974|TWO_SIDED|95.0|-0.25|0.02||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||0.02|-0.25|0.0974
91526061|NCT03502616|182927267|SUPERIORITY||Difference in percentage|13.03|STANDARD_ERROR_OF_MEAN|5.94||0.0282|TWO_SIDED|95.0|1.39|24.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||24.66|1.39|0.0282
91526062|NCT03502616|182927267|SUPERIORITY||Difference in percentage|10.77|STANDARD_ERROR_OF_MEAN|5.98||0.0719|TWO_SIDED|95.0|-0.96|22.49|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.49|-0.96|0.0719
91526063|NCT03502616|182927268|SUPERIORITY||Difference in percentage|32.79|STANDARD_ERROR_OF_MEAN|4.75|<|0.0001|TWO_SIDED|95.0|23.48|42.11|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.11|23.48|<0.0001
91526064|NCT03502616|182927268|SUPERIORITY||Difference in percentage|40.53|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001|TWO_SIDED|95.0|30.37|50.7|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||50.70|30.37|<0.0001
91526065|NCT03502616|182927268|SUPERIORITY||Difference in percentage|45.22|STANDARD_ERROR_OF_MEAN|5.2|<|0.0001|TWO_SIDED|95.0|35.03|55.41|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.41|35.03|<0.0001
91526066|NCT03502616|182927268|SUPERIORITY||Difference in percentage|45.23|STANDARD_ERROR_OF_MEAN|5.23|<|0.0001|TWO_SIDED|95.0|34.97|55.49|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.49|34.97|<0.0001
91526067|NCT03502616|182927268|SUPERIORITY||Difference in percentage|42.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|31.73|52.88|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||52.88|31.73|<0.0001
91526068|NCT03502616|182927268|SUPERIORITY||Difference in percentage|4.96|STANDARD_ERROR_OF_MEAN|5.85||0.3967|TWO_SIDED|95.0|-6.51|16.42|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.42|-6.51|0.3967
91526069|NCT03502616|182927268|SUPERIORITY||Difference in percentage|4.34|STANDARD_ERROR_OF_MEAN|5.67||0.4442|TWO_SIDED|95.0|-6.78|15.46|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.46|-6.78|0.4442
91526070|NCT03502616|182927268|SUPERIORITY||Difference in percentage|6.38|STANDARD_ERROR_OF_MEAN|5.92||0.281|TWO_SIDED|95.0|-5.22|17.97|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.97|-5.22|0.2810
91526071|NCT03502616|182927268|SUPERIORITY||Difference in percentage|5.54|STANDARD_ERROR_OF_MEAN|5.95||0.3514|TWO_SIDED|95.0|-6.12|17.2|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.20|-6.12|0.3514
91526072|NCT03502616|182927269|SUPERIORITY||Difference in percentage|8.84|STANDARD_ERROR_OF_MEAN|2.74||0.0013|TWO_SIDED|95.0|3.46|14.21|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|3.46|0.0013
91526073|NCT03502616|182927269|SUPERIORITY||Difference in percentage|16.25|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|9.13|23.36|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||23.36|9.13|<0.0001
91670619|NCT04100096|183236482|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.391|TWO_SIDED|95.0|-0.2|0.08||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 12||0.08|-0.20|0.3910
91670620|NCT04100096|183236483|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0063|TWO_SIDED|9.0|0.04|0.26||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.26|0.04|0.0063
91670621|NCT04100096|183236483|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.067|TWO_SIDED|95.0|-0.01|0.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.19|-0.01|0.0670
91670622|NCT00784134|183236537|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.027||||0.554|TWO_SIDED|95.0|-0.062|0.115|||Chi-squared|||||0.115|-0.062|0.554
91526074|NCT03502616|182927269|SUPERIORITY||Difference in percentage|20.31|STANDARD_ERROR_OF_MEAN|4.03|<|0.0001|TWO_SIDED|95.0|12.41|28.2|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||28.20|12.41|<0.0001
91526075|NCT03502616|182927269|SUPERIORITY||Difference in percentage|22.77|STANDARD_ERROR_OF_MEAN|4.24|<|0.0001|TWO_SIDED|95.0|14.46|31.08|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.08|14.46|<0.0001
91526076|NCT03502616|182927269|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|16.47|34.1|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||34.10|16.47|<0.0001
91526077|NCT03502616|182927269|SUPERIORITY||Difference in percentage|9.41|STANDARD_ERROR_OF_MEAN|5.62||0.0941|TWO_SIDED|95.0|-1.61|20.43|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.43|-1.61|0.0941
91526078|NCT03502616|182927269|SUPERIORITY||Difference in percentage|2.52|STANDARD_ERROR_OF_MEAN|5.96||0.6727|TWO_SIDED|95.0|-9.17|14.21|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|-9.17|0.6727
91526079|NCT03502616|182927269|SUPERIORITY||Difference in percentage|7.29|STANDARD_ERROR_OF_MEAN|5.96||0.2213|TWO_SIDED|95.0|-4.39|18.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.98|-4.39|0.2213
91526080|NCT03502616|182927269|SUPERIORITY||Difference in percentage|4.7|STANDARD_ERROR_OF_MEAN|5.76||0.4137|TWO_SIDED|95.0|-6.58|15.98|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.98|-6.58|0.4137
91526081|NCT03502616|182927270|SUPERIORITY||Difference in percentage|0.75|STANDARD_ERROR_OF_MEAN|1.27||0.5518|TWO_SIDED|95.0|-1.73|3.24|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||3.24|-1.73|0.5518
91526082|NCT03502616|182927270|SUPERIORITY||Difference in percentage|3.72|STANDARD_ERROR_OF_MEAN|1.92||0.0524|TWO_SIDED|95.0|-0.04|7.47|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||7.47|-0.04|0.0524
91526083|NCT03502616|182927270|SUPERIORITY||Difference in percentage|5.25|STANDARD_ERROR_OF_MEAN|2.29||0.0216|TWO_SIDED|95.0|0.77|9.73|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.73|0.77|0.0216
91526084|NCT03502616|182927270|SUPERIORITY||Difference in percentage|10.48|STANDARD_ERROR_OF_MEAN|2.9||0.0003|TWO_SIDED|95.0|4.8|16.17|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.17|4.80|0.0003
91526085|NCT03502616|182927270|SUPERIORITY||Difference in percentage|6.69|STANDARD_ERROR_OF_MEAN|2.37||0.0047|TWO_SIDED|95.0|2.05|11.33|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.33|2.05|0.0047
91526086|NCT03502616|182927270|SUPERIORITY||Difference in percentage|1.07|STANDARD_ERROR_OF_MEAN|3.98||0.7883|TWO_SIDED|95.0|-6.74|8.88|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.88|-6.74|0.7883
91526087|NCT03502616|182927270|SUPERIORITY||Difference in percentage|4.85|STANDARD_ERROR_OF_MEAN|4.4||0.2708|TWO_SIDED|95.0|-3.78|13.48|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||13.48|-3.78|0.2708
91637188|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-2.89|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-12.01|6.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||6.23|-12.01|
91637189|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|95.0|-6.78|11.13|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||11.13|-6.78|
91637190|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|4.68|||TWO_SIDED|95.0|-13.93|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||5.47|-13.93|
91670623|NCT00784134|183236537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.465|TWO_SIDED|95.0|0.75|1.87||Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.|Multivariable Logit Model|||||1.87|0.75|0.465
91670624|NCT00784134|183236538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.484|TWO_SIDED|95.0|0.63|1.25||Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score \> K v. \<= K for K = 1 - 4; Alt v. Sal.|Generalized ordered Logit Model|||||1.25|0.63|0.484
91670625|NCT00784134|183236538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.71||The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).|Generalized ordered Logit Model|||||0.71|0.28|<0.001
91526088|NCT03502616|182927270|SUPERIORITY||Difference in percentage|0.44|STANDARD_ERROR_OF_MEAN|4.55||0.9226|TWO_SIDED|95.0|-8.48|9.36|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.36|-8.48|0.9226
91526089|NCT03502616|182927270|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.23||0.663|TWO_SIDED|95.0|-6.44|10.13|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.13|-6.44|0.6630
91637191|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|1.37|STANDARD_ERROR_OF_MEAN|4.59|||TWO_SIDED|95.0|-8.14|10.88|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||10.88|-8.14|
91637192|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-0.57|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-10.32|9.18|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||9.18|-10.32|
91637193|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|2.49|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-7.04|12.02|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||12.02|-7.04|
91637194|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-7.89|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-18.33|2.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||2.55|-18.33|
91670626|NCT00784134|183236539|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.552|TWO_SIDED|95.0|-0.059|0.111|||Chi-squared|||||0.111|-0.059|0.552
91670627|NCT00784134|183236539|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.35|TWO_SIDED|95.0|0.8|1.9||Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Multivariable Logit Model|||||1.90|0.80|0.350
91670628|NCT00784134|183236540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.428|TWO_SIDED|95.0|0.78|1.8||Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Random Effects Model|||||1.80|0.78|0.428
91670629|NCT00784134|183236541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.384|TWO_SIDED|95.0|0.75|2.1|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 30 days||2.10|0.75|0.384
91670630|NCT00784134|183236541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.964|TWO_SIDED|95.0|0.62|1.64|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 180 days||1.64|0.62|0.964
91670631|NCT00784134|183236542|SUPERIORITY_OR_OTHER|||||||0.0056|||||||Log Rank|||||||0.0056
91526090|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.319||0.0099|TWO_SIDED|95.0|-1.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.47|0.0099
91670632|NCT00784134|183236543|SUPERIORITY_OR_OTHER||||||<|0.001|||||||AUC/ Logit Model|||||||<0.001
91670633|NCT00784134|183236544|SUPERIORITY_OR_OTHER|||||||0.771|||||||Kruskal-Wallis|||||||0.771
91670634|NCT00784134|183236545|SUPERIORITY_OR_OTHER|||||||0.098|||||||Kruskal-Wallis|||||||0.098
91670635|NCT00784134|183236546|SUPERIORITY_OR_OTHER|||||||0.45|||||||Generalized Linear Models|||||||0.450
91670636|NCT00784134|183236547|SUPERIORITY_OR_OTHER|||||||0.501|||||||Chi-squared|||||||0.501
91670637|NCT00784134|183236548|SUPERIORITY_OR_OTHER|||||||0.795|||||||Chi-squared|||||||0.795
91670638|NCT00784134|183236549|SUPERIORITY_OR_OTHER|||||||0.784|||||||Chi-squared|||||||0.784
91670639|NCT00784134|183236550|SUPERIORITY_OR_OTHER|||||||0.592|||||||Chi-squared|||||||0.592
91670640|NCT00784134|183236551|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared|||||||0.105
91670641|NCT00784134|183236552|SUPERIORITY_OR_OTHER|||||||0.152|||||||Chi-squared|||||||0.152
91670642|NCT00784134|183236553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.055||||0.055|TWO_SIDED|95.0|-0.111|0.008|||Fisher Exact|||||0.008|-0.111|0.055
91670643|NCT00784134|183236554|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.035||||0.202|TWO_SIDED|95.0|-0.084|0.014|||Fisher Exact|||||0.014|-0.084|0.202
91670644|NCT00784134|183236555|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.771|TWO_SIDED|95.0|-0.022|0.03|||Fisher Exact|||||0.030|-0.022|0.771
91670645|NCT00784134|183236556|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.811|TWO_SIDED|95.0|-0.028|0.036|||Fisher Exact|||||0.036|-0.028|0.811
91670646|NCT00784134|183236557|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.144||||0.0017|TWO_SIDED|95.0|-0.23|-0.057|||Fisher Exact|||||-0.057|-0.230|0.0017
91670647|NCT00784134|183236558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.006|TWO_SIDED|95.0|0.41|0.86|||Cox Proportional Hazards Model|Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||||0.86|0.41|0.006
91670648|NCT00784134|183236559|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.064||||0.41|TWO_SIDED|95.0|-0.088|0.217|||Chi-squared|||||0.217|-0.088|0.410
91670649|NCT00784134|183236560|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.016||||0.781|TWO_SIDED|95.0|-0.096|0.128|||Chi-squared|||||0.128|-0.096|0.781
91670650|NCT00784134|183236561|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.773|TWO_SIDED|95.0|-0.113|0.152|||Chi-squared|||||0.152|-0.113|0.773
91670651|NCT00784134|183236562|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.032||||0.587|TWO_SIDED|95.0|-0.085|0.151|||Chi-squared|||||0.151|-0.085|0.587
91670652|NCT00784134|183236563|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.015||||0.775|TWO_SIDED|95.0|-0.09|0.121|||Chi-squared|||||0.121|-0.09|0.775
91670653|NCT00784134|183236564|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.019||||0.808|TWO_SIDED|95.0|-0.132|0.169|||Chi-squared|||||0.169|-0.132|0.808
91670654|NCT00784134|183236565|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.033||||0.625|TWO_SIDED|95.0|-0.165|0.099|||Chi-squared|||||0.099|-0.165|0.625
91670655|NCT00784134|183236566|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.087||||0.191|TWO_SIDED|95.0|-0.043|0.218|||Chi-squared|||||0.218|-0.043|0.191
91670656|NCT00784134|183236567|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0066||||0.949|TWO_SIDED|95.0|-0.197|0.211|||Chi-squared|||||0.211|-0.197|0.949
91670657|NCT00784134|183236568|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.014||||0.812|TWO_SIDED|95.0|-0.098|0.126|||Chi-squared|||||0.126|-0.098|0.812
91670658|NCT00784134|183236569|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.059||||0.394|TWO_SIDED|95.0|-0.076|0.194|||Chi-squared|||||0.194|-0.076|0.394
91670659|NCT00784134|183236570|SUPERIORITY_OR_OTHER|||||||0.312|||||||Wilcoxon (Mann-Whitney)|||||||0.312
91670660|NCT00784134|183236571|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.075||||0.087|TWO_SIDED|95.0|-0.011|0.16||Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores|Chi-squared|||||0.160|-0.011|0.087
91670661|NCT00784134|183236571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.064|TWO_SIDED|95.0|0.98|2.43||Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline|Multivariable Logit Model|||||2.43|0.98|0.064
91670662|NCT00784134|183236571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.336|TWO_SIDED|95.0|0.7|2.89||Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||2.89|0.70|0.336
91670663|NCT00784134|183236571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.783|TWO_SIDED|95.0|0.57|1.52||Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||1.52|0.57|0.783
91670664|NCT00784134|183236572|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91670665|NCT00784134|183236573|SUPERIORITY_OR_OTHER|||||||0.312|||||||t-test, 2 sided|||||||0.312
91670666|NCT00784134|183236574|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
91670667|NCT00784134|183236575|SUPERIORITY_OR_OTHER|||||||0.478|||||||t-test, 2 sided|||||||0.478
91670668|NCT00784134|183236576|SUPERIORITY_OR_OTHER|||||||0.634|||||||t-test, 2 sided|||||||0.634
91670669|NCT00784134|183236577|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|||||||0.255
91670670|NCT00784134|183236578|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
91670671|NCT00784134|183236579|SUPERIORITY_OR_OTHER|||||||0.882|||||||t-test, 2 sided|||||||0.882
91670672|NCT00784134|183236580|SUPERIORITY_OR_OTHER|||||||0.551|||||||t-test, 2 sided|||||||0.551
91670673|NCT00784134|183236581|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
91485292|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|0.03||||0.9327||95.0|-0.63|0.69||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.69|-0.63|0.9327
91670674|NCT00784134|183236582|SUPERIORITY_OR_OTHER|||||||0.376|||||||t-test, 2 sided|||||||0.376
91670675|NCT01796964|183236604|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 12 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-1.13|||||TWO_SIDED|80.0|-4.19|1.93|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 12.||1.93|-4.19|
91670676|NCT01796964|183236605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 16 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-0.58|||||TWO_SIDED|80.0|-3.72|2.56|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 16.||2.56|-3.72|
91670677|NCT04025684|183236613|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.11|-0.08||Analysis was performed using ANCOVA Model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.11|<.0001
91670678|NCT04025684|183236613|SUPERIORITY||Adjusted Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.14|-0.1||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.10|-0.14|<0.0001
91670679|NCT04025684|183236613|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
91670680|NCT04025684|183236613|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
91670681|NCT04025684|183236614|SUPERIORITY||Adjusted Mean Change|-0.5|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.62|-0.37||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.37|-0.62|<0.0001
91670682|NCT04025684|183236614|SUPERIORITY||Adjusted Mean Change|-0.62|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.75|-0.49||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.49|-0.75|<0.0001
91715262|NCT00810199|183321692|SUPERIORITY_OR_OTHER|||||||0.7776||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.7776
91715263|NCT00810199|183321692|SUPERIORITY_OR_OTHER|||||||0.8843|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8843
91670683|NCT04025684|183236614|SUPERIORITY||Adjusted Mean Change|-0.55|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.68|-0.42||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.42|-0.68|<0.0001
91670684|NCT04025684|183236614|SUPERIORITY||Adjusted Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.7|-0.44||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.44|-0.70|<0.0001
91670685|NCT01239472|183236643|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91670686|NCT01239472|183236644|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91715264|NCT00810199|183321693|SUPERIORITY_OR_OTHER|||||||0.9095||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9095
91715265|NCT00810199|183321693|SUPERIORITY_OR_OTHER|||||||0.7179|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7179
91715266|NCT00810199|183321694|SUPERIORITY_OR_OTHER|||||||0.3113||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.3113
91670687|NCT03662308|183236645|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91670688|NCT00418522|183236652|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.19|||<|0.0001||95.0|-0.38|0.0|||ANCOVA||A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||0|-0.38|<0.0001
91670689|NCT00418522|183236652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0516||95.0|-0.38|0.0|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||0|-0.38|0.0516
91670690|NCT00418522|183236653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0052||95.0|1.22|3.14|||Regression, Logistic|||||3.14|1.22|0.0052
91715267|NCT00810199|183321694|SUPERIORITY_OR_OTHER|||||||0.2931||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.2931
91715268|NCT00810199|183321695|SUPERIORITY_OR_OTHER|||||||0.2451||95.0||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.2451
91715269|NCT00810199|183321695|SUPERIORITY_OR_OTHER|||||||0.8841||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8841
91670691|NCT00418522|183236654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0022||95.0|1.29|3.15|||Regression, Logistic|||||3.15|1.29|0.0022
91670692|NCT00418522|183236655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.248||95.0|0.4|1.27|||Regression, Logistic|||||1.27|0.40|0.2480
91670693|NCT00418522|183236656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.57||||0.6091||95.0|-7.31|12.46|||ANCOVA|||||12.46|-7.31|0.6091
91670694|NCT00418522|183236657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.96|||<|0.0001||95.0|22.66|43.25|||ANCOVA|||Time 0 (fasting) at Week 26.||43.25|22.66|<0.0001
91670695|NCT00418522|183236657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||<|0.0001||95.0|16.55|40.59|||ANCOVA|||Time 30 at Week 26.||40.59|16.55|<0.0001
91670696|NCT00418522|183236657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.96||||0.0044||95.0|5.96|31.96|||ANCOVA|||Time 60 at Week 26.||31.96|5.96|0.0044
91670697|NCT00418522|183236657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.69||||0.3168||95.0|-6.45|19.83|||ANCOVA|||Time 90 at Week 26.||19.83|-6.45|0.3168
91670698|NCT00418522|183236657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.9222||95.0|-12.12|13.39|||ANCOVA|||Time 120 at Week 26.||13.39|-12.12|0.9222
91670699|NCT00418522|183236657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.695||95.0|-14.51|9.69|||ANCOVA|||Time 180 at Week 26.||9.69|-14.51|0.6950
91670700|NCT00418522|183236658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.61||||0.1207||95.0|-21.76|2.54|||ANCOVA|||Post-Breakfast, Week 26.||2.54|-21.76|0.1207
91670701|NCT00418522|183236658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|||<|0.0001||95.0|-39.77|-18.44|||ANCOVA|||Post-Lunch, Week 26.||-18.44|-39.77|<0.0001
91670702|NCT00418522|183236658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.76|||<|0.0001||95.0|-44.17|-23.35|||ANCOVA|||Post-Dinner, Week 26.||-23.35|-44.17|<0.0001
91670703|NCT00418522|183236659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21||||0.0735||95.0|-0.5|10.91|||ANCOVA|||Total Cholesterol at Week 26.||10.91|-0.50|0.0735
91670704|NCT00418522|183236659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.0017||95.0|0.79|3.39|||ANCOVA|||HDL-c at Week 26.||3.39|0.79|0.0017
91670705|NCT00418522|183236659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.1369||95.0|-1.1|7.96|||ANCOVA|||LDL-c at Week 26.||7.96|-1.10|0.1369
91670706|NCT00418522|183236659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26||||0.5684||95.0|-10.4|18.92|||ANCOVA|||Triglycerides at Week 26.||18.92|-10.40|0.5684
91670707|NCT00418522|183236660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.5673||95.0|-0.58|1.06|||ANCOVA|||hs-CRP at Week 26.||1.06|-0.58|0.5673
91670708|NCT00418522|183236660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.6099||95.0|-2.97|1.75|||ANCOVA|||Leptin at Week 26.||1.75|-2.97|0.6099
91670709|NCT00418522|183236660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.28||||0.7684||95.0|-12.94|17.51|||ANCOVA|||Spot urine microalbumin at Week 26.||17.51|-12.94|0.7684
91670710|NCT00418522|183236661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.5005||95.0|-0.69|1.42|||ANCOVA|||Adiponectin at Week 26.||1.42|-0.69|0.5005
91715270|NCT00810199|183321696|SUPERIORITY_OR_OTHER|||||||0.9655||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9655
91715271|NCT00810199|183321696|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.0308
91715272|NCT00810199|183321697|SUPERIORITY_OR_OTHER|||||||0.5186||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.5186
91715273|NCT00810199|183321697|SUPERIORITY_OR_OTHER|||||||0.7706||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7706
91715274|NCT00810199|183321698|SUPERIORITY_OR_OTHER|||||||0.6067||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.6067
91715275|NCT00810199|183321698|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.6810
91715276|NCT00810199|183321699|SUPERIORITY_OR_OTHER|||||||0.9323||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9323
91715277|NCT00810199|183321699|SUPERIORITY_OR_OTHER|||||||0.1448||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1448
91715278|NCT00810199|183321700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.2034|TWO_SIDED|95.0|-0.43|0.09||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.09|-0.43|0.2034
91670711|NCT00418522|183236661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|-0.03|0.04|||ANCOVA|||ApoB at Week 26.||0.04|-0.03|0.6850
91670712|NCT00418522|183236662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.7||||0.1856||95.0|-43.37|160.77|||ANCOVA|||||160.77|-43.37|0.1856
91715279|NCT00810199|183321700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3611|TWO_SIDED|95.0|-0.88|0.32||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.32|-0.88|0.3611
91715280|NCT00810199|183321700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0342|TWO_SIDED|95.0|-1.16|-0.05||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.05|-1.16|0.0342
91715281|NCT00810199|183321701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7095|TWO_SIDED|95.0|-0.23|0.16||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.16|-0.23|0.7095
91715282|NCT00810199|183321701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8147|TWO_SIDED|95.0|-0.45|0.57||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.57|-0.45|0.8147
91715283|NCT00810199|183321701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0778|TWO_SIDED|95.0|-0.67|0.04||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||0.04|-0.67|0.0778
91715284|NCT00810199|183321702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0441|TWO_SIDED|95.0|-0.25|0.0||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||-0.00|-0.25|0.0441
91715285|NCT00810199|183321702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0012|TWO_SIDED|95.0|-0.54|-0.13||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||-0.13|-0.54|0.0012
91715286|NCT00810199|183321702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0372|TWO_SIDED|95.0|-0.56|-0.02||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.02|-0.56|0.0372
91670713|NCT00418522|183236663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.72||||0.1862||95.0|-51.34|13.89|||ANCOVA|||||13.89|-51.34|0.1862
91670714|NCT00418522|183236669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.0055||95.0|0.35|2.04|||ANCOVA|||||2.04|0.35|0.0055
91670715|NCT00418522|183236670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.0053||95.0|0.12|0.71|||ANCOVA|||||0.71|0.12|0.0053
91670716|NCT00418522|183236672|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.27|||<|0.0001||95.0|-0.47|-0.08|||ANCOVA||A CI approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||-0.08|-0.47|<0.0001
91670717|NCT00418522|183236672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0062||95.0|-0.47|-0.08|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||-0.08|-0.47|0.0062
91715287|NCT00810199|183321703|SUPERIORITY_OR_OTHER||Difference|6.75||||0.0694|TWO_SIDED|95.0|-1.02|14.52|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||Week 52||14.52|-1.02|0.0694
91715288|NCT00810199|183321703|SUPERIORITY_OR_OTHER|||||||0.1695|TWO_SIDED||||||Log Rank|||Week 104||||0.1695
91715289|NCT00810199|183321704|SUPERIORITY_OR_OTHER||Difference|-2.91||||0.0496||95.0|-5.86|0.05|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||0.05|-5.86|0.0496
91715290|NCT00810199|183321705|SUPERIORITY_OR_OTHER||Difference|-1.48||||0.5188|TWO_SIDED|95.0|-6.59|3.62|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||3.62|-6.59|0.5188
91715291|NCT00810199|183321706|SUPERIORITY_OR_OTHER|||||||0.2652|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.2652
91715292|NCT00810199|183321706|SUPERIORITY_OR_OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1970
91715293|NCT00810199|183321706|SUPERIORITY_OR_OTHER|||||||0.1671|||||||Wilcoxon (Mann-Whitney)|||||||0.1671
91715294|NCT00810199|183321708|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|5.22||||0.111|TWO_SIDED|95.0|-1.2|11.64|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||11.64|-1.20|0.1110
91715295|NCT00810199|183321709|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|-2.11||||0.6027|TWO_SIDED|95.0|-10.07|5.85|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||5.85|-10.07|0.6027
91715296|NCT00810199|183321710|SUPERIORITY_OR_OTHER|||||||0.1695|||||||Log Rank|||||||0.1695
91715297|NCT00810199|183321711|SUPERIORITY_OR_OTHER|||||||0.0096|||||||Log Rank|||||||0.0096
91715298|NCT00810199|183321712|SUPERIORITY_OR_OTHER|||||||0.0734|||||||Log Rank|||||||0.0734
91715299|NCT01691378|183321724|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.03|TWO_SIDED|95.0|0.52|8.3|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BHS compared bet arms controlling for T1 BHS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BHS as function of arm \& T1 BHS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.3|.52|.03
91722538|NCT02629159|183337902|SUPERIORITY||LS Mean Difference|-9.92||||0.164|TWO_SIDED|95.0|-23.89|4.05||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||4.05|-23.89|0.164
91670718|NCT02695719|183236673|SUPERIORITY||Median Values of CI|1.0||||0.007|TWO_SIDED|95.0|0.1|1.9||No adjustment was made as there was only one primary comparison.|Van Elteren Test|The Van Elteren test is a stratified version of the Wilcoxon-Mann-Whitney test which provides approximate sample size for the van Elteren analysis.|CI was estimated by inverting the hypothesis test.|Assuming equal allocation, a power of 90%, an alpha level of 0.05 for a 2-sided test, a placebo mean of 4 (standard deviation of 2.7), and a treatment mean of 5.9 (standard deviation of 4) for SBM frequency at Week 1 and using Wilcoxon-Mann-Whitney test, a total sample size of 146 is required. Analysis was conducted using van Elteren test.||1.9|0.1|0.007
91670719|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.857||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in length z-score.||||0.857
91670720|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.901||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in weight z-score.||||0.901
91670721|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.807||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in head circumference z-score.||||0.807
91670722|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.595|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.595
91670723|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.016
91670724|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.347
91670725|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.040
91670726|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.892|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.892
91670727|NCT00868296|183236689|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.006
91670728|NCT02250651|183236723|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738|TWO_SIDED|95.0|-1.17|0.44|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.44|-1.17|0.3738
91670729|NCT02250651|183236723|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514|TWO_SIDED|95.0|-0.88|0.73|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.73|-0.88|0.8514
91670730|NCT02250651|183236723|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401|TWO_SIDED|95.0|-1.57|-0.04|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.04|-1.57|0.0401
91670731|NCT02250651|183236723|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.41|-1.12|0.3621
91670732|NCT02250651|183236724|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382||95.0|-1.48|-0.04|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
91670733|NCT02250651|183236724|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133||95.0|-1.29|0.14|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
91670734|NCT02250651|183236725|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013||95.0|-1.76|-0.43|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
91670735|NCT02250651|183236725|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364||95.0|-1.38|-0.05|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
91670736|NCT02250651|183236726|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304||95.0|-1.22|0.29|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
91670737|NCT02250651|183236726|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272||95.0|-1.34|0.17|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
91670738|NCT02250651|183236727|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038||95.0|-1.76|-0.34|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
91670739|NCT02250651|183236727|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741||95.0|-1.36|0.06|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
91670740|NCT02250651|183236728|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738||95.0|-1.17|0.44|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.44|-1.17|0.3738
91670741|NCT02250651|183236728|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514||95.0|-0.88|0.73|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.73|-0.88|0.8514
91792743|NCT02387476|183463172|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.36|<|0.001|TWO_SIDED|95.0|-0.4|1.0||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean ODI values are rounded to a single decimal point value in the text of the table (1.4 and 1.1, respectively) to ensure consistency with ODI reporting standards.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||1.0|-0.4|<0.001
91792744|NCT00829985|183463191|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.92|||<|0.0001|TWO_SIDED|95.0|1.51|2.45|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 1.12) vs. the extract group (numerator = 2.16).|||2.45|1.51|<0.0001
91670742|NCT02250651|183236729|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401||95.0|-1.57|-0.04|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.57|0.0401
91715300|NCT01691378|183321724|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.01|TWO_SIDED|95.0|-7.9|-1.3|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-1.3|-7.9|.01
91670743|NCT02250651|183236729|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.41|-1.12|0.3621
91670744|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382|TWO_SIDED|95.0|-1.48|-0.04|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
91670745|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133|TWO_SIDED|95.0|-1.29|0.14|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
91670746|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013|TWO_SIDED|95.0|-1.76|-0.43|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
91670747|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364|TWO_SIDED|95.0|-1.38|-0.05|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
91715301|NCT01691378|183321724|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0007|TWO_SIDED|95.0|-9.3|-3.2|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-3.2|-9.3|.0007
91715302|NCT01691378|183321725|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.07|TWO_SIDED|95.0|-0.29|8.0|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BSS compared bet arms controlling for T1 BSS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BSS as function of arm \& T1 BSS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.0|-.29|.07
91715303|NCT01691378|183321725|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.94|TWO_SIDED|95.0|-3.3|3.1|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||3.1|-3.3|.94
91792745|NCT00829985|183463192|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.13||||0.088|TWO_SIDED|95.0|0.98|1.32|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 0.93) vs. the extract group (numerator = 1.06).|||1.32|0.98|0.088
91792746|NCT00829985|183463193|SUPERIORITY_OR_OTHER||Treatment Effect|0.37||||0.37|TWO_SIDED|95.0|-4.89|12.99|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.7) minus change in the placebo group (0.7).|||12.99|-4.89|0.37
91792747|NCT00829985|183463194|SUPERIORITY_OR_OTHER||Treatment Effect|5.4||||0.09|TWO_SIDED|95.0|-0.77|11.51|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.0) minus change in the placebo group (-1.3).|||11.51|-0.77|0.09
91715304|NCT01691378|183321725|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.06|TWO_SIDED|95.0|-7.0|0.12|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||.12|-7.0|.06
91670748|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304|TWO_SIDED|95.0|-1.22|0.29|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
91670749|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272|TWO_SIDED|95.0|-1.34|0.17|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
91670750|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038|TWO_SIDED|95.0|-1.76|-0.34|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
91670751|NCT02250651|183236730|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741|TWO_SIDED|95.0|-1.36|0.06|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
91670752|NCT01557920|183236738|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||pathological swallows under anesthesia vs. wakefulness: 25.9% vs. 4.9%|Mixed Models Analysis|||||||0.001
91670753|NCT01557920|183236738|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Comparison of pathological swallow-rate increase by carbon-dioxide during anesthesia and wakefulness||||<0.001
91670754|NCT01557920|183236743|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The number of swallows per hour: 1.7±3.3 during anesthesia vs. 28.0±22.3 during wakefulness|Mixed Models Analysis|||||||<0.001
91670755|NCT02690935|183236756|SUPERIORITY|||||||0.642||||||No adjustment of the p-value|t-test, 2 sided|||H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different||||0.642
91670756|NCT02690935|183236757|SUPERIORITY|||||||0.829||||||No adjustment for multiplicity|t-test, 2 sided|||H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life||||0.829
91670757|NCT01493596|183236763|OTHER|Comparison of event rates across dose groups.|percentage|14.3|||||TWO_SIDED||||||||There were a total of 5 non-serious adverse events for an AE rate of 14.3%|Descriptive statistics for evaluation of AEs|Descriptive statistics of adverse events|||
91670758|NCT01175473|183236764|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-154.42|||<|0.0001|TWO_SIDED|95.0|-180.3|-128.54||Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System \[SAS®\] PROC MIXED procedure).|Linear fixed effects model|No alpha adjustment was performed.||To detect a difference of 100 or 150 h\*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h\*mg/dL, respectively, with a 2-sided test at 5% significance level.||-128.54|-180.30|<0.0001
91670759|NCT02630316|183236774|SUPERIORITY||Hodges-Lehmann|21.0||||0.0043|TWO_SIDED|95.0|7.0|37.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||37.0|7.0|0.0043
91670760|NCT02630316|183236775|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91670761|NCT02630316|183236776|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.041|TWO_SIDED|95.0|0.4|0.92||p-value is calculated with log-rank test stratified by baseline 6MWD category.|Log Rank||p-value was 0.0202 for the proportional hazard model. Hazard ratio, 95% confidence interval (CI), and p-values are calculated with proportional hazards model with treatment and Baseline 6MWD (continuous) as explanatory variables.|||0.92|0.40|0.0410
91670762|NCT02630316|183236777|SUPERIORITY||Hodges-Lehmann|20.0||||0.0041|TWO_SIDED|95.0|7.0|34.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category|ANCOVA|||||34.0|7.0|0.0041
91670763|NCT02630316|183236778|SUPERIORITY||Hodges-Lehmann|15.0||||0.0432|TWO_SIDED|95.0|0.0|29.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||29.0|0.0|0.0432
91670764|NCT02508116|183236779|SUPERIORITY||Odds Ratio (OR)|1.6||||0.03|TWO_SIDED|95.0|1.07|2.42|||Regression, Logistic|||The sample size calculation was based on two factors: 1) the rate of pre-study prasugrel/ticagrelor use (\~20%) and 2) anticipated increase in prasugrel/ticagrelor prescribing based on the frequency CYP2C19 LOF variants (\~30-35%). We estimated a 15% difference in the use of prasugrel/ticagrelor in the two groups (35% in the genotyped group and 20% in the control group). A sample size of 138 per group (a total of 276) would provide 80% power at an alpha level of 0.05 to detect this difference.||2.42|1.07|0.03
91670765|NCT02508116|183236781|SUPERIORITY|||||||0.27|||||||Log Rank|||The incidence of first MACE between the groups were compared by use of Kaplan-Meier estimators; statistical tests were based on log-rank tests.||||0.27
91670766|NCT04234464|183236792|SUPERIORITY||Mean Difference (Final Values)|13.51|||<|0.001|TWO_SIDED|95.0|10.09|16.94|||Mixed Models Analysis|||Maximum percentage fall in post-dose pre-exercise FEV₁ up to 60 minutes post-exercise challenge is analyzed using a mixed effects model adjusted for treatment, treatment period, treatment sequence as categorical fixed effects, period-specific pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||16.94|10.09|<0.001
91670767|NCT04234464|183236793|SUPERIORITY||Odds Ratio (OR)|10.548|||<|0.001|TWO_SIDED|95.0|4.311|25.805|||Mixed Models Analysis|||A generalized linear mixed model with logit link adjusted for treatment, treatment period and treatment sequence as fixed effects, pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||25.805|4.311|<0.001
91670768|NCT03635983|183236794|SUPERIORITY||Estimate of Odds Ratio (OR)|0.66||||0.0311|TWO_SIDED|95.0|0.45|0.96|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||0.96|0.45|0.0311
91670769|NCT03635983|183236795|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3988||95.0|0.89|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.89|0.3988
91670770|NCT03635983|183236796|SUPERIORITY|Bempegaldesleukin+Nivolumab over Nivolumab|Hazard Ratio (HR)|0.94||||0.6361|TWO_SIDED|95.0|0.72|1.22|||Log Rank|2-sided p-value. Boundary for statistical significance p-value \< 0.00071|Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab.|||1.22|0.72|0.6361
91670771|NCT03635983|183236800|SUPERIORITY||Estimate of Odds Ratio (OR)|0.7||||0.0626|TWO_SIDED|95.0|0.48|1.02|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||1.02|0.48|0.0626
91670772|NCT03635983|183236801|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3713||95.0|0.9|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.90|0.3713
91670773|NCT03635983|183236805|SUPERIORITY||Odds Ratio (OR)|0.63||||||95.0|0.32|1.24|||||Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Negative: \<1%)||1.24|0.32|
91670774|NCT03635983|183236805|SUPERIORITY||Odds Ratio (OR)|0.63||||0.9939|TWO_SIDED|95.0|0.39|1.02|||Stratified Cochran-Mantel-Haenszel|Interaction P-value|Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Positive: \>=1%)||1.02|0.39|0.9939
91670775|NCT03635983|183236806|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.43|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.43|0.81|
91792748|NCT02751931|183463224|OTHER||Mean Difference (Net)|72.09|||<|0.001|TWO_SIDED|95.0|45.28|98.89||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||98.89|45.28|<0.001
91670776|NCT03635983|183236806|SUPERIORITY||Hazard Ratio (HR)|1.12||||||95.0|0.83|1.51|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.51|0.83|
91670777|NCT03635983|183236807|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.66|1.4|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.40|0.66|
91670778|NCT03635983|183236807|SUPERIORITY||Hazard Ratio (HR)|0.88||||||95.0|0.58|1.33|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.33|0.58|
91670779|NCT02578745|183236814|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
91670780|NCT02578745|183236815|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
91670781|NCT02578745|183236816|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91670782|NCT02578745|183236817|SUPERIORITY||||||>|0.99|TWO_SIDED|95.0|||||Chi-squared|||||||>0.99
91670783|NCT02578745|183236818|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
91670784|NCT02578745|183236819|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.50
91670785|NCT00330460|183236820|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.22%.|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.7|1.2|||ANCOVA|||||1.2|0.7|<0.0001
91670786|NCT00330460|183236821|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -2.29%.|Mean Difference (Final Values)|1.1|||<|0.0001||95.0|0.7|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.7|<0.0001
91670787|NCT00330460|183236822|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.65%|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.6|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.6|<0.0001
91670788|NCT00330460|183236823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.04%|Mean Difference (Final Values)|0.6|||<|0.0001||95.0|0.3|1.0||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1|0.3|<0.0001
91670789|NCT00330460|183236824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0001||95.0|0.3|0.9||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||0.9|0.3|0.0001
91670790|NCT04458467|183236833|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
91670791|NCT04458467|183236834|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91670792|NCT00104247|183236939|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91670793|NCT02030535|183237000|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.187|0.252||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation|Tio+Olo 5/5μg minus Placebo.|||0.252|0.187|<0.0001
91670794|NCT02030535|183237000|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.252|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.22|0.284||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation.|Tiotropium 5μg + Olodaterol 5μg minus Placebo.|||0.284|0.220|<0.0001
91637195|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-16.92|3.95|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||3.95|-16.92|
91670795|NCT02030535|183237000|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.033|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.065|-0.001|||||Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.|Descriptive comparison. Statistical Analyses 1 \& 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)||-0.001|-0.065|
91526091|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.332||0.0275|TWO_SIDED|95.0|-1.4|-0.08|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.08|-1.40|0.0275
91637196|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-3.84|STANDARD_ERROR_OF_MEAN|4.91|||TWO_SIDED|95.0|-14.03|6.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.35|-14.03|
91637197|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|0.78|STANDARD_ERROR_OF_MEAN|4.62|||TWO_SIDED|95.0|-8.8|10.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||10.35|-8.80|
91526092|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.35||0.042|TWO_SIDED|95.0|-1.41|-0.03|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.41|0.0420
91526093|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.349||0.1309|TWO_SIDED|95.0|-1.22|0.16|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.16|-1.22|0.1309
91526094|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.305||0.5566|TWO_SIDED|95.0|-0.78|0.42|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.42|-0.78|0.5566
91637198|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-17.79|3.53|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.53|-17.79|
91637199|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|1.66|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-8.59|11.91|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||11.91|-8.59|
91637200|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-6.31|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|95.0|-16.17|3.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||3.55|-16.17|
91670796|NCT01634854|183237018|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91670797|NCT00966381|183237040|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91670798|NCT00966381|183237041|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91526095|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.248||0.4497|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.30|-0.68|0.4497
91637201|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-1.17|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-10.6|8.27|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||8.27|-10.60|
91637202|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-7.01|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-19.13|5.11|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||5.11|-19.13|
91637203|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-4.11|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-15.55|7.34|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||7.34|-15.55|
91637204|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|1.77|STANDARD_ERROR_OF_MEAN|5.48|||TWO_SIDED|95.0|-9.63|13.17|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||13.17|-9.63|
91637205|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-3.47|STANDARD_ERROR_OF_MEAN|5.18|||TWO_SIDED|95.0|-14.25|7.31|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.31|-14.25|
91637206|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-1.73|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|95.0|-11.24|7.77|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||7.77|-11.24|
91637207|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|4.46|||TWO_SIDED|95.0|-14.83|3.73|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.73|-14.83|
91670799|NCT00966381|183237042|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91670800|NCT03686150|183237049|OTHER|This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.||||||||||||||||Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|||
91670801|NCT03686150|183237050|OTHER|This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level \>= 40 ng/mL is 50%.||||||0.0001|||||||z-test|||This is a one-sample test of proportion.||||0.0001
91670802|NCT03346070|183237061|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.0075|TWO_SIDED|95.0|1.18|3.1|||Log Rank||Cox regression model|||3.10|1.18|0.0075
91670803|NCT03346070|183237061|SUPERIORITY||Hazard Ratio (HR)|25.9|||<|0.0001|TWO_SIDED|95.0|9.72|69.03|||Log Rank||Cox regression model|||69.03|9.72|<0.0001
91670804|NCT03346070|183237061|SUPERIORITY||Hazard Ratio (HR)|61.4|||<|0.0001|TWO_SIDED|95.0|14.13|266.77|||Log Rank||Cox regression model|||266.77|14.13|<0.0001
91670805|NCT03346070|183237061|SUPERIORITY||Hazard Ratio (HR)|2.38||||0.0005|TWO_SIDED|95.0|1.44|3.93|||Log Rank||Cox regression model|||3.93|1.44|0.0005
91792749|NCT02751931|183463224|OTHER||Mean Difference (Net)|113.21|||<|0.001|TWO_SIDED|95.0|78.95|147.47||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||147.47|78.95|<0.001
91792750|NCT02751931|183463225|OTHER||Mean Difference (Net)|-4.09||||0.618|TWO_SIDED|95.0|-20.55|12.38||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||12.38|-20.55|0.618
91670806|NCT03346070|183237061|SUPERIORITY||Hazard Ratio (HR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.5|3.01|||Log Rank||Cox regression model|||3.01|1.50|<0.0001
91670807|NCT03346070|183237062|SUPERIORITY||Difference in percentage|2.3||||0.602|TWO_SIDED|95.0|-9.6|15.0|||Miettinen & Nurminen method|||||15.0|-9.6|0.602
91792751|NCT02751931|183463225|OTHER||Mean Difference (Net)|15.16||||0.005|TWO_SIDED|95.0|5.1|25.22||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||25.22|5.10|0.005
91670808|NCT03346070|183237062|SUPERIORITY||Difference in percentage|0.2||||0.969|TWO_SIDED|95.0|-13.4|13.5|||Miettinen & Nurminen method|||||13.5|-13.4|0.969
91670809|NCT03346070|183237062|SUPERIORITY||Difference in percentage|2.6||||0.567|TWO_SIDED|95.0|-8.7|15.0|||Miettinen & Nurminen method|||||15.0|-8.7|0.567
91670810|NCT03346070|183237062|SUPERIORITY||Difference in percentage|2.6||||0.571|TWO_SIDED|95.0|-8.8|15.0|||Miettinen & Nurminen method|||||15.0|-8.8|0.571
91670811|NCT03346070|183237062|SUPERIORITY||Difference in percentage|-0.2||||0.95|TWO_SIDED|95.0|-11.6|10.9|||Miettinen & Nurminen method|||||10.9|-11.6|0.950
91670812|NCT03346070|183237062|SUPERIORITY||Difference in percentage|2.9||||0.528|TWO_SIDED|95.0|-8.4|15.9|||Miettinen & Nurminen method|||||15.9|-8.4|0.528
91670813|NCT03346070|183237062|SUPERIORITY||Difference in percentage|1.3||||0.709|TWO_SIDED|95.0|-6.8|9.6|||Miettinen & Nurminen method|||||9.6|-6.8|0.709
91670814|NCT03346070|183237063|SUPERIORITY||Difference in percentage|2.2||||0.738|TWO_SIDED|95.0|-12.3|17.4|||Miettinen & Nurminen method|||||17.4|-12.3|0.738
91670815|NCT03346070|183237063|SUPERIORITY||Difference in percentage|11.1||||0.077|TWO_SIDED|95.0|-1.7|26.3|||Miettinen & Nurminen method|||||26.3|-1.7|0.077
91670816|NCT03346070|183237063|SUPERIORITY||Difference in percentage|2.4||||0.717|TWO_SIDED|95.0|-12.0|16.4|||Miettinen & Nurminen method|||||16.4|-12.0|0.717
91670817|NCT03346070|183237063|SUPERIORITY||Difference in percentage|5.0||||0.486|TWO_SIDED|95.0|-9.9|19.7|||Miettinen & Nurminen method|||||19.7|-9.9|0.486
91670818|NCT03346070|183237063|SUPERIORITY||Difference in percentage|-1.2||||0.849|TWO_SIDED|95.0|-16.2|12.4|||Miettinen & Nurminen method|||||12.4|-16.2|0.849
91670819|NCT03346070|183237063|SUPERIORITY||Difference in percentage|-4.9||||0.339|TWO_SIDED|95.0|-18.2|6.7|||Miettinen & Nurminen method|||||6.7|-18.2|0.339
91670820|NCT03346070|183237063|SUPERIORITY||Difference in percentage|6.6||||0.149|TWO_SIDED|95.0|-2.6|16.8|||Miettinen & Nurminen method|||||16.8|-2.6|0.149
91670821|NCT03346070|183237064|SUPERIORITY||Difference in percentage|-2.7||||0.299|TWO_SIDED|95.0|-13.9|6.7|||Miettinen & Nurminen method|||||6.7|-13.9|0.299
91670822|NCT03346070|183237064|SUPERIORITY||Difference in percentage|0.0|||>|0.999|TWO_SIDED|95.0|-9.9|9.4|||Miettinen & Nurminen method|||||9.4|-9.9|>0.999
91670823|NCT03346070|183237064|SUPERIORITY||Difference in percentage|-2.6||||0.326|TWO_SIDED|95.0|-13.7|7.0|||Miettinen & Nurminen method|||||7.0|-13.7|0.326
91670824|NCT03346070|183237064|SUPERIORITY||Difference in percentage|-2.5||||0.335|TWO_SIDED|95.0|-13.6|7.1|||Miettinen & Nurminen method|||||7.1|-13.6|0.335
91670825|NCT03346070|183237064|SUPERIORITY||Difference in percentage|0.3||||0.935|TWO_SIDED|95.0|-11.1|11.9|||Miettinen & Nurminen method|||||11.9|-11.1|0.935
91670826|NCT03346070|183237064|SUPERIORITY||Difference in percentage|-2.7||||0.326|TWO_SIDED|95.0|-13.8|7.3|||Miettinen & Nurminen method|||||7.3|-13.8|0.326
91670827|NCT03346070|183237064|SUPERIORITY||Difference in percentage|-1.4||||0.299|TWO_SIDED|95.0|-7.5|3.5|||Miettinen & Nurminen method|||||3.5|-7.5|0.299
91670828|NCT03346070|183237065|SUPERIORITY||Difference in percentage|0.1|||||TWO_SIDED|95.0|-12.7|13.1|||||Miettinen and Nurminen method|||13.1|-12.7|
91670829|NCT03346070|183237065|SUPERIORITY||Difference in percentage|-3.6|||||TWO_SIDED|95.0|-19.6|12.2|||||Miettinen and Nurminen method|||12.2|-19.6|
91670830|NCT03346070|183237065|SUPERIORITY||Difference in percentage|5.1|||||TWO_SIDED|95.0|-8.1|19.7|||||Miettinen and Nurminen method|||19.7|-8.1|
91670831|NCT03346070|183237065|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-18.0|13.1|||||Miettinen and Nurminen method|||13.1|-18.0|
91792752|NCT02751931|183463225|OTHER||Mean Difference (Net)|14.62||||0.055|TWO_SIDED|95.0|-0.31|29.54||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||29.54|-0.31|0.055
91670832|NCT03346070|183237065|SUPERIORITY||Difference in percentage|4.4|||||TWO_SIDED|95.0|-9.6|19.2|||||Miettinen and Nurminen method|||19.2|-9.6|
91670833|NCT03346070|183237065|SUPERIORITY||Difference in percentage|2.2|||||TWO_SIDED|95.0|-12.5|17.0|||||Miettinen and Nurminen method|||17.0|-12.5|
91670834|NCT03346070|183237065|SUPERIORITY||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-11.4|7.8|||||Miettinen and Nurminen method|||7.8|-11.4|
91670835|NCT03346070|183237066|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-15.2|9.1|||||Miettinen and Nurminen method|||9.1|-15.2|
91670836|NCT03346070|183237066|SUPERIORITY||Difference in percentage|-8.5|||||TWO_SIDED|95.0|-22.3|1.3|||||Miettinen and Nurminen method|||1.3|-22.3|
91670837|NCT03346070|183237066|SUPERIORITY||Difference in percentage|-5.3|||||TWO_SIDED|95.0|-18.8|6.8|||||Miettinen and Nurminen method|||6.8|-18.8|
91670838|NCT03346070|183237066|SUPERIORITY||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-21.2|1.8|||||Miettinen and Nurminen method|||1.8|-21.2|
91670839|NCT03346070|183237066|SUPERIORITY||Difference in percentage|-2.9|||||TWO_SIDED|95.0|-17.0|10.5|||||Miettinen and Nurminen method|||10.5|-17.0|
91670840|NCT03346070|183237066|SUPERIORITY||Difference in percentage|0.5|||||TWO_SIDED|95.0|-14.0|15.5|||||Miettinen and Nurminen method|||15.5|-14.0|
91670841|NCT03346070|183237066|SUPERIORITY||Difference in percentage|-5.5|||||TWO_SIDED|95.0|-13.9|1.2|||||Miettinen and Nurminen method|||1.2|-13.9|
91670842|NCT03346070|183237067|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-13.4|7.3|||||Miettinen and Nurminen method|||7.3|-13.4|
91670843|NCT03346070|183237067|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-12.3|10.8|||||Miettinen and Nurminen method|||10.8|-12.3|
91670844|NCT03346070|183237067|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.7|7.0|||||Miettinen and Nurminen method|||7.0|-13.7|
91670845|NCT03346070|183237067|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.2|11.7|||||Miettinen and Nurminen method|||11.7|-11.2|
91670846|NCT03346070|183237067|SUPERIORITY||Difference in percentage|-0.2|||||TWO_SIDED|95.0|-11.5|11.0|||||Miettinen and Nurminen method|||11.0|-11.5|
91670847|NCT03346070|183237067|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.0|12.0|||||Miettinen and Nurminen method|||12.0|-11.0|
91670848|NCT03346070|183237068|SUPERIORITY||Difference in percentage|3.0|||||TWO_SIDED|95.0|-10.8|16.9|||||Miettinen and Nurminen method|||16.9|-10.8|
91670849|NCT03346070|183237068|SUPERIORITY||Difference in percentage|-76.1|||||TWO_SIDED|95.0|-87.2|-57.6|||||Miettinen and Nurminen method|||-57.6|-87.2|
91670850|NCT03346070|183237068|SUPERIORITY||Difference in percentage|-78.7|||||TWO_SIDED|95.0|-88.8|-61.1|||||Miettinen and Nurminen method|||-61.1|-88.8|
91670851|NCT03346070|183237068|SUPERIORITY||Difference in percentage|2.8|||||TWO_SIDED|95.0|-7.2|14.2|||||Miettinen and Nurminen method|||14.2|-7.2|
91670852|NCT03346070|183237068|SUPERIORITY||Difference in percentage|2.9|||||TWO_SIDED|95.0|-4.8|11.0|||||Miettinen and Nurminen method|||11.0|-4.8|
91670853|NCT03346070|183237069|SUPERIORITY||Ratio of geometric means|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Log transformation and t-distribution|||0.86|0.48|
91670854|NCT03346070|183237069|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.06|0.12|||||Log transformation and t-distribution|||0.12|0.06|
91670855|NCT03346070|183237069|SUPERIORITY||Ratio of geometric means|0.14|||||TWO_SIDED|95.0|0.1|0.19|||||Log transformation and t-distribution|||0.19|0.10|
91670856|NCT03346070|183237069|SUPERIORITY||Ratio of geometric means|0.54|||||TWO_SIDED|95.0|0.4|0.71|||||Log transformation and t-distribution|||0.71|0.40|
91670857|NCT03346070|183237069|SUPERIORITY||Ratio of geometric means|0.59|||||TWO_SIDED|95.0|0.48|0.72|||||Log transformation and t-distribution|||0.72|0.48|
91670858|NCT03346070|183237070|SUPERIORITY||Ratio of geometric means|0.63|||||TWO_SIDED|95.0|0.5|0.8|||||Log transformation and t-distribution|||0.80|0.50|
91670859|NCT03346070|183237070|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.07|0.13|||||Log transformation and t-distribution|||0.13|0.07|
91670860|NCT03346070|183237070|SUPERIORITY||Ratio of geometric means|0.15|||||TWO_SIDED|95.0|0.11|0.2|||||Log transformation and t-distribution|||0.20|0.11|
91670861|NCT03346070|183237070|SUPERIORITY||Ratio of geometric means|0.56|||||TWO_SIDED|95.0|0.44|0.72|||||Log transformation and t-distribution|||0.72|0.44|
91670862|NCT03346070|183237070|SUPERIORITY||Ratio of geometric means|0.6|||||TWO_SIDED|95.0|0.51|0.7|||||Log transformation and t-distribution|||0.70|0.51|
91670863|NCT03346070|183237071|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.54|0.81|||||Log transformation and t-distribution|||0.81|0.54|
91670864|NCT03346070|183237071|SUPERIORITY||Ratio of geometric means|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Log transformation and t-distribution|||0.17|0.09|
91670865|NCT03346070|183237071|SUPERIORITY||Ratio of geometric means|0.19|||||TWO_SIDED|95.0|0.14|0.27|||||Log transformation and t-distribution|||0.27|0.14|
91670866|NCT03346070|183237071|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.52|0.83|||||Log transformation and t-distribution|||0.83|0.52|
91670867|NCT03346070|183237071|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.57|0.77|||||Log transformation and t-distribution|||0.77|0.57|
91670868|NCT03404401|183237072|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91670869|NCT01844531|183237077|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.92|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|93.529|102.52||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.520|93.529|0.0000
91670870|NCT01844531|183237077|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.3|<|0.0001|TWO_SIDED|90.0|93.57|102.65||Model included effects:sequence;subjects within sequences;period and treatment with all effects as fixed.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.65|93.57|<.0001
91526096|NCT03502616|182927271|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9272|TWO_SIDED|95.0|-0.43|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.43|0.9272
91526097|NCT03502616|182927271|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.273||0.2539|TWO_SIDED|95.0|-0.85|0.23|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.23|-0.85|0.2539
91526098|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.479||0.4379|TWO_SIDED|95.0|-0.58|1.33|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.33|-0.58|0.4379
91526099|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.532||0.534|TWO_SIDED|95.0|-0.73|1.39|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.39|-0.73|0.5340
91526100|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.582||0.9148|TWO_SIDED|95.0|-1.1|1.22|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.22|-1.10|0.9148
91526101|NCT03502616|182927272|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.548||0.5409|TWO_SIDED|95.0|-1.43|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|-1.43|0.5409
91526102|NCT03502616|182927272|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.607||0.3555|TWO_SIDED|95.0|-1.78|0.65|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.65|-1.78|0.3555
91637208|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|1.98|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-8.85|12.81|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||12.81|-8.85|
91637209|NCT03091920|183166562|OTHER|No statistical testing was performed.|Least squares mean difference|1.07|STANDARD_ERROR_OF_MEAN|4.69|||TWO_SIDED|95.0|-8.68|10.82|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||10.82|-8.68|
91637210|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-2.12|STANDARD_ERROR_OF_MEAN|2.06|||TWO_SIDED|95.0|-6.38|2.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.15|-6.38|
91637211|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-2.39|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-6.59|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.80|-6.59|
91637212|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-6.11|1.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||1.60|-6.11|
91637213|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-8.25|1.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.47|-8.25|
91637214|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|95.0|-6.4|3.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.18|-6.40|
91637215|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-6.9|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.90|-6.90|
91637216|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-4.96|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|95.0|-11.22|1.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.31|-11.22|
91637217|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.84|||TWO_SIDED|95.0|-10.41|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.40|-10.41|
91637218|NCT03091920|183166563|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-10.27|0.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.81|-10.27|
91637219|NCT03091920|183166564|OTHER|No statistical testing was performed.|Least squares mean difference|-4.87|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-10.8|1.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.06|-10.80|
91526103|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.436||0.2485|TWO_SIDED|95.0|-0.36|1.38|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.36|0.2485
91526104|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.435||0.0866|TWO_SIDED|95.0|-0.11|1.63|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.63|-0.11|0.0866
91526105|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.356||0.4101|TWO_SIDED|95.0|-0.42|1.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.01|-0.42|0.4101
91526106|NCT03502616|182927272|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.217||0.0237|TWO_SIDED|95.0|0.07|0.94|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.94|0.07|0.0237
91526107|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.107||0.0043|TWO_SIDED|95.0|0.1|0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|0.10|0.0043
91526108|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.121||0.0072|TWO_SIDED|95.0|0.09|0.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.56|0.09|0.0072
91526109|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.146||0.1101|TWO_SIDED|95.0|-0.05|0.52|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|-0.05|0.1101
91526110|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0147|TWO_SIDED|95.0|0.06|0.58|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.58|0.06|0.0147
91526111|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.162||0.2032|TWO_SIDED|95.0|-0.11|0.53|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.53|-0.11|0.2032
91526112|NCT03502616|182927273|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.168||0.9345|TWO_SIDED|95.0|-0.34|0.32|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.32|-0.34|0.9345
91526113|NCT03502616|182927273|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.187||0.5968|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.27|-0.47|0.5968
91526114|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.166||0.7047|TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.39|-0.26|0.7047
91526115|NCT03502616|182927273|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.157||0.807|TWO_SIDED|95.0|-0.27|0.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.35|-0.27|0.8070
91637220|NCT03091920|183166564|OTHER|No statistical testing was performed.|Least squares mean difference|-5.02|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.87|0.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.83|-10.87|
91637221|NCT03091920|183166564|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.55|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.10|-9.55|
91792753|NCT02751931|183463225|OTHER||Mean Difference (Net)|13.59|||<|0.001|TWO_SIDED|95.0|6.75|20.42||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||20.42|6.75|<0.001
91792754|NCT02751931|183463226|OTHER||Mean Difference (Net)|41.36|||<|0.001|TWO_SIDED|95.0|18.75|63.97||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change from Baseline at week 4 - Children.||63.97|18.75|<0.001
91637222|NCT03091920|183166564|OTHER|No statistical testing was performed.|Least squares mean difference|-2.15|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-7.4|3.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.11|-7.40|
91670871|NCT01844531|183237077|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.79|STANDARD_ERROR_OF_MEAN|6.7||0|TWO_SIDED|90.0|99.077|106.633||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500 , PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||106.633|99.077|0.0000
91670872|NCT01844531|183237077|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.5|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|90.0|98.78|106.36|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 (T2) : Empa5 + Met500 (R2), PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.36|98.78|<.0001
91670873|NCT01844531|183237078|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.25|STANDARD_ERROR_OF_MEAN|15.4||0.0006|TWO_SIDED|90.0|88.542|104.628|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.628|88.542|0.0006
91670874|NCT01844531|183237078|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.21|STANDARD_ERROR_OF_MEAN|15.1||0.0004|TWO_SIDED|90.0|89.41|105.68|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 (T1) : Empa12.5 + Met500 (R1), PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.68|89.41|0.0004
91670875|NCT01844531|183237078|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.79|STANDARD_ERROR_OF_MEAN|9.8||0|TWO_SIDED|90.0|91.772|102.093|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.093|91.772|0.0000
91670876|NCT01844531|183237078|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.91|STANDARD_ERROR_OF_MEAN|9.8|<|0.0001|TWO_SIDED|90.0|91.79|102.32|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.32|91.79|<.0001
91670877|NCT01844531|183237079|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.5||0|TWO_SIDED|90.0|93.53|102.686|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.686|93.530|0.0000
91670878|NCT01844531|183237079|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.07|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|93.55|102.81|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.81|93.55|<.0001
91670879|NCT01844531|183237079|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.77|STANDARD_ERROR_OF_MEAN|6.5||0|TWO_SIDED|90.0|99.146|106.522|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.522|99.146|0.0000
91670880|NCT01844531|183237079|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.49|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|90.0|98.85|106.25|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.25|98.85|<.0001
91670881|NCT01844531|183237080|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.61|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|99.882|109.555|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.555|99.882|0.0000
91670882|NCT01844531|183237080|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.53|STANDARD_ERROR_OF_MEAN|8.4|<|0.0001|TWO_SIDED|90.0|99.76|109.53|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.53|99.76|<.0001
91670883|NCT01844531|183237080|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.96|STANDARD_ERROR_OF_MEAN|9.2||0|TWO_SIDED|90.0|97.917|108.258|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.258|97.917|0.0000
91670884|NCT01844531|183237080|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.8|STANDARD_ERROR_OF_MEAN|9.2|<|0.0001|TWO_SIDED|90.0|97.72|108.14|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.14|97.72|<.0001
91670885|NCT01844531|183237081|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.76|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|89.056|100.819|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.819|89.056|0.0001
91670886|NCT01844531|183237081|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.4|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|88.64|100.54|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.54|88.64|0.0001
91670887|NCT01844531|183237081|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.83|STANDARD_ERROR_OF_MEAN|11.9||0.0002|TWO_SIDED|90.0|88.006|100.034|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.034|88.006|0.0002
91670888|NCT01844531|183237081|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.98|STANDARD_ERROR_OF_MEAN|12.0||0.0003|TWO_SIDED|90.0|87.94|100.43|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.43|87.94|0.0003
91670889|NCT01844531|183237082|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.78|STANDARD_ERROR_OF_MEAN|15.7||0.0008|TWO_SIDED|90.0|88.0|104.256|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.256|88.000|0.0008
91670890|NCT01844531|183237082|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.74|STANDARD_ERROR_OF_MEAN|15.5||0.0006|TWO_SIDED|90.0|88.78|105.41|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.41|88.78|0.0006
91670891|NCT01844531|183237082|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.94|STANDARD_ERROR_OF_MEAN|9.3||0|TWO_SIDED|90.0|91.199|100.934|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||100.934|91.199|0.0000
91670892|NCT01844531|183237082|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.1|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|90.0|91.28|101.19|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||101.19|91.28|<.0001
91670893|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rivermead Behavioural Memory Test (RBMT) - Immediate memory||||0.861
91670894|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.668||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT - Delayed memory||||0.668
91670895|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT-Delayed corrected for immediate memory||||0.713
91670896|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.028||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Short-term memory||||0.028
91670897|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.227||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Total immediate memory||||0.227
91670898|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.13||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Learning Score||||0.130
91670899|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.106||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test- Delayed memory||||0.106
91670900|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.35||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Delayed corrected for total memory||||0.350
91670901|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.093||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Recognition||||0.093
91670902|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.614||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit Span forward - Short-term memory||||0.614
91670903|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.111||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Immediate memory||||0.111
91670904|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.451||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Delayed memory||||0.451
91670905|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.905||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time auditory response||||0.905
91670906|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.502||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time visual response||||0.502
91670907|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.531||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of omission errors||||0.531
91670908|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.681||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of commission errors||||0.681
91670909|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Reaction time for target stimuli||||0.713
91670910|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.229||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of omission errors||||0.229
91670911|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.329||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of commission errors||||0.329
91670912|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.192||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time tonic alertness||||0.192
91670913|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.164||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time phasic alertness||||0.164
91670914|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.536||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Semantic fluency||||0.536
91670915|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.572||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Phonemic fluency||||0.572
91670916|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.632||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit span backward - Working memory||||0.632
91670917|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.512||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition A||||0.512
91670918|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition B||||0.861
91670919|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.958||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Condition B/A||||0.958
91670920|NCT01546922|183237083|SUPERIORITY_OR_OTHER|||||||0.819||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Social cognition||||0.819
91670921|NCT04894084|183237089|SUPERIORITY||Risk Ratio (RR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.49|||Poisson loglinear model|||||0.49|0.07|<0.001
91670922|NCT04894084|183237090|OTHER||Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0||"Low degree + Very low degree / Not at all were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."||99|72|<0.0001
91670923|NCT04894084|183237091|OTHER||Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0||"Some degree, High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For reliability answered on a 5-point scale the answers some, high, or very high degree was considered acceptable and grouped against answers of 'low or very low' degree of reliability.||93|56|0.0106
91670924|NCT04894084|183237092|OTHER||Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0||"Same, Better and Much better were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. For ability to move with test product it was tested if the proportion evaluating same or better was significantly different from 50% when using a 5% test level. The answers of 'same, better or much better' was grouped against the answers of 'worse or much worse' ability to move.||100|78|<0.0001
91670925|NCT04894084|183237093|OTHER|Users worry of leakage given on a 5-point scale was analyzed by a proportional odds ratio model taken the paired design into consideration to compare the results from V1 and V2.|||||<|0.001|||||||Proportional odds ratio model|||||||<0.001
91670926|NCT04894084|183237094|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
91670927|NCT04894084|183237095|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|65.2||||0.21|TWO_SIDED|95.0|43.0|84.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||84|43|0.21
91670928|NCT04894084|183237096|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
91526116|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.055||0.003|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 16, Mobility: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.06|-0.28|0.0030
91526117|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.055||0.897|TWO_SIDED|95.0|-0.11|0.1|||ANCOVA|||Week 16, Self-Care: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.10|-0.11|0.8970
91526118|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.058||0.1437|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|||Week 16, Usual Activities: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.03|-0.20|0.1437
91526119|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|-0.27|-0.09|||ANCOVA|||Week 16, Pain/Discomfort: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.09|-0.27|<0.0001
91526120|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8445|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Week 16, Anxiety/Depression: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.11|-0.13|0.8445
91526121|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.064||0.3473|TWO_SIDED|95.0|-0.19|0.07|||Mixed Models Analysis|||Week 48, Mobility: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.19|0.3473
91526122|NCT03502616|182927274|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9834|TWO_SIDED|95.0|-0.12|0.12|||Mixed Models Analysis|||Week 48, Self-Care: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.12|-0.12|0.9834
91526123|NCT03502616|182927274|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.066||0.7364|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|||Week 48, Usual Activities: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.15|-0.11|0.7364
91526124|NCT03502616|182927274|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8075|TWO_SIDED|95.0|-0.13|0.1|||Mixed Models Analysis|||Week 48, Pain/Discomfort: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.10|-0.13|0.8075
91526125|NCT03502616|182927274|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.067||0.5461|TWO_SIDED|95.0|-0.09|0.17|||Mixed Models Analysis|||Week 48, Anxiety/Depression: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.17|-0.09|0.5461
91526126|NCT03502616|182927275|SUPERIORITY||LS mean difference|10.11|STANDARD_ERROR_OF_MEAN|2.331|<|0.0001|TWO_SIDED|95.0|5.52|14.7|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||14.70|5.52|<0.0001
91526127|NCT03502616|182927275|SUPERIORITY||LS mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.337||0.2608|TWO_SIDED|95.0|-1.97|7.24|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.24|-1.97|0.2608
91637223|NCT03091920|183166564|OTHER|No statistical testing was performed.|Least squares mean difference|-8.74|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.64|-1.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.85|-15.64|
91637224|NCT03091920|183166564|OTHER|No statistical testing was performed.|Least squares mean difference|-5.34|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-11.84|1.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.15|-11.84|
91670929|NCT04894084|183237097|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|69.6||||0.093|TWO_SIDED|95.0|47.0|87.0|||Exact test in the binomial distribution|||||87|47|0.093
91670930|NCT04894084|183237098|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion with a positive response was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0|||Exact test in the binomial distribution|||||100|78|<0.0001
91526128|NCT03502616|182927276|SUPERIORITY||LS mean difference|-4.53|STANDARD_ERROR_OF_MEAN|3.35||0.1784|TWO_SIDED|95.0|-11.15|2.09|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||2.09|-11.15|0.1784
91637225|NCT03091920|183166565|OTHER|No statistical testing was performed.|Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-4.86|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.96|-4.86|
91637226|NCT03091920|183166565|OTHER|No statistical testing was performed.|Least squares mean difference|-0.71|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-5.07|3.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.65|-5.07|
91526129|NCT03502616|182927276|SUPERIORITY||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|2.54||0.3651|TWO_SIDED|95.0|-7.34|2.72|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.72|-7.34|0.3651
91526130|NCT03502616|182927277|SUPERIORITY||LS mean difference|-12.89|STANDARD_ERROR_OF_MEAN|2.884|<|0.0001|TWO_SIDED|95.0|-18.59|-7.19|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.19|-18.59|<0.0001
91526131|NCT03502616|182927277|SUPERIORITY||LS mean difference|-2.36|STANDARD_ERROR_OF_MEAN|3.318||0.4788|TWO_SIDED|95.0|-8.92|4.21|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.21|-8.92|0.4788
91670931|NCT04894084|183237099|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion answering I felt more confident was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0|||Exact test in the binomial distribution|||||99|72|<0.0001
91670932|NCT04894084|183237100|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|34.8||||0.21|TWO_SIDED|95.0|16.0|57.0||"Yes, to the better was tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||57|16|0.21
91670933|NCT04894084|183237101|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|47.8||||1|TWO_SIDED|95.0|27.0|69.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||69|27|1.00
91670934|NCT04894084|183237102|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|56.5||||0.678|TWO_SIDED|95.0|34.0|77.0|||Exact test in the binomial distribution|||||77|34|0.678
91670935|NCT04894084|183237104|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|69.6||||0.0931|TWO_SIDED|95.0|47.0|87.0||"High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||87|47|0.0931
91526132|NCT03502616|182927278|SUPERIORITY||LS mean difference|-13.85|STANDARD_ERROR_OF_MEAN|3.202|<|0.0001|TWO_SIDED|95.0|-20.18|-7.52|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.52|-20.18|<0.0001
91670936|NCT04894084|183237105|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|87.0||||0.0005|TWO_SIDED|95.0|66.0|97.0|||Exact test in the binomial distribution|||||97|66|0.0005
91670937|NCT02551679|183237108|SUPERIORITY||Cox Proportional Hazard|2.046||||0.258|TWO_SIDED|95.0|0.577|7.255|||ANCOVA|||The primary hypothesis of this study is that ACP-01 is superior to placebo in terms of the earlier time from treatment with Investigational Medicinal Product (IMP) to either de-novo gangrene, or doubling of wound size, or major amputation, or death.||7.255|0.577|0.258
91670938|NCT01573533|183237116|SUPERIORITY|||||||0.49|||||||ANOVA|||Baseline vs 12 months||||0.49
91526133|NCT03502616|182927278|SUPERIORITY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|3.613||0.2244|TWO_SIDED|95.0|-11.56|2.74|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.74|-11.56|0.2244
91670939|NCT01573533|183237117|SUPERIORITY|||||||0.41|||||||ANOVA|||Baseline vs 12 months||||0.41
91670940|NCT01573533|183237118|SUPERIORITY|||||||0.06|||||||ANOVA|||Baseline vs 12 months||||0.06
91670941|NCT00317642|183237122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.78|1.28|||Log Rank|||Full Analysis Set (FAS) population||1.28|0.78|0.9951
91670942|NCT00317642|183237122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4674|TWO_SIDED|95.0|0.81|1.57|||Log Rank|||Participants stratified by calculated strata remission after first pre-study induction regimen (CR1) \< 6 months||1.57|0.81|0.4674
91670943|NCT00317642|183237122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3963|TWO_SIDED|95.0|0.58|1.24|||Log Rank|||Participants stratified by calculated strata CR1\>= 6 months||1.24|0.58|0.3963
91526134|NCT03502616|182927279|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|2.488|<|0.0001|TWO_SIDED|95.0|-18.3|-8.5|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-8.50|-18.30|<0.0001
91792755|NCT02751931|183463226|OTHER||Mean Difference (Net)|80.78|||<|0.001|TWO_SIDED|95.0|39.2|122.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||122.36|39.20|<0.001
91792756|NCT02751931|183463227|OTHER||Mean Difference (Net)|0.44||||0.632|TWO_SIDED|95.0|-1.4|2.28||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||2.28|-1.40|0.632
91526135|NCT03502616|182927279|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.905||0.0095|TWO_SIDED|95.0|-13.32|-1.88|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.88|-13.32|0.0095
91526136|NCT04503096|182927281|OTHER|To monitor safety, paired t-tests were conducted to test for pre- to post-treatment differences in global cognition (i.e., MoCA z-scores).||||||0.725|||||||t-test, 2 sided|||||||0.725
91526137|NCT04503096|182927285|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using HAM-D raw scores.||||||0.605|||||||t-test, 2 sided|||||||.605
91526138|NCT04503096|182927286|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using GDS raw scores.||||||0.897|||||||t-test, 2 sided|||||||.897
91526139|NCT04503096|182927287|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in cognition using Fluid Cognition Composite Scores.|||||<|0.001|||||||t-test, 2 sided|||||||< .001
91526140|NCT01872910|182927292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-2.1|20.0|||||95% CrI is reported here, not the CI.|||20.0|-2.1|
91526141|NCT01872910|182927292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.6|||||TWO_SIDED|95.0|-45.7|-23.2|||||95% CrI is reported here, not the CI.|||-23.2|-45.7|
91526142|NCT01872910|182927292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.6|||||TWO_SIDED|95.0|32.7|54.9|||||95% CrI is reported here, not the CI.|||54.9|32.7|
91526143|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.9|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||0.2|-2.9|
91526144|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|2.9|6.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||6.0|2.9|
91526145|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-7.4|-4.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||-4.3|-7.4|
91526146|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.2|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||0.2|-5.2|
91526147|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|4.4|9.8|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||9.8|4.4|
91670944|NCT00317642|183237123|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - overall remission (OR)||||<0.0001
91670945|NCT00317642|183237123|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - Complete Remission (CR)||||0.0005
91526148|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|||||TWO_SIDED|95.0|-12.2|-6.9|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||-6.9|-12.2|
91526149|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-7.9|-0.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-0.1|-7.9|
91526150|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|||||TWO_SIDED|95.0|5.3|13.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||13.0|5.3|
91526151|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-16.9|-9.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-9.3|-16.9|
91526152|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|||||TWO_SIDED|95.0|-13.2|0.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||0.5|-13.2|
91526153|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|||||TWO_SIDED|95.0|6.6|19.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||19.2|6.6|
91526154|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-25.9|-13.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||-13.5|-25.9|
91526155|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|||||TWO_SIDED|95.0|-30.8|-2.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-2.0|-30.8|
91526156|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.0|37.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||37.2|9.0|
91526157|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.4|||||TWO_SIDED|95.0|-53.2|-25.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-25.3|-53.2|
91526158|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.5|1.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||1.6|-1.5|
91526159|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.9|2.4|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||2.4|-2.9|
91526160|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-4.7|3.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||3.1|-4.7|
91670946|NCT00317642|183237123|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Overall Remission (CR+CRi)\]||||0.0022
91670947|NCT00317642|183237123|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Overall Remission (CR+CRi)\]||||0.0019
91670948|NCT00317642|183237123|SUPERIORITY_OR_OTHER|||||||0.0353||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Complete Remission (CR)\]||||0.0353
91792757|NCT02751931|183463227|OTHER||Mean Difference (Net)|-0.64||||0.321|TWO_SIDED|95.0|-1.94|0.67|||t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.67|-1.94|0.321
91670949|NCT00317642|183237123|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Complete Remission (CR)\]||||0.0096
91670950|NCT00317642|183237128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0001|TWO_SIDED|95.0|0.49|0.8|||Log Rank|||Full Analysis Set (FAS) population.||0.80|0.49|0.0001
91526161|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-8.3|4.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||4.1|-8.3|
91526162|NCT01872910|182927293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|||||TWO_SIDED|95.0|-21.4|7.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||7.6|-21.4|
91526163|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-4.2|14.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||14.5|-4.2|
91526164|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.0|||||TWO_SIDED|95.0|-41.5|-22.4|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||-22.4|-41.5|
91526165|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|27.8|46.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||46.5|27.8|
91526166|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3|||||TWO_SIDED|95.0|-2.9|17.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||17.6|-2.9|
91526167|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.1|||||TWO_SIDED|95.0|-45.6|-24.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||-24.6|-45.6|
91526168|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.5|||||TWO_SIDED|95.0|32.1|52.7|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||52.7|32.1|
91526169|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|23.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||23.0|-1.0|
91526170|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.7|||||TWO_SIDED|95.0|-45.1|-20.3|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||-20.3|-45.1|
91526171|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.5|||||TWO_SIDED|95.0|31.3|55.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||55.5|31.3|
91526172|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.4|||||TWO_SIDED|95.0|-1.6|26.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||26.2|-1.6|
91526173|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.2|||||TWO_SIDED|95.0|-44.0|-16.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||-16.0|-44.0|
91526174|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.6|||||TWO_SIDED|95.0|28.6|56.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||56.5|28.6|
91670951|NCT00317642|183237128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.0131|TWO_SIDED|95.0|0.49|0.93|||Log Rank|Comparison P-value is from a log-rank test with no strata||Participants stratified by randomization strata CR1 \<6 months||0.93|0.49|0.0131
91526175|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-9.7|12.9|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||12.9|-9.7|
91526176|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-9.8|16.8|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||16.8|-9.8|
91526177|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|-9.9|19.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h.|||19.0|-9.9|
91526178|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-9.2|21.1|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||21.1|-9.2|
91526179|NCT01872910|182927294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-8.4|24.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||24.2|-8.4|
91526180|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.9|||||95% CrI is reported here, not the CI. Estimation is SPID 0 to 4 h.|||1.9|-0.6|
91526181|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.1|-1.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||-1.7|-4.1|
91526182|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.3|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||4.8|2.3|
91526183|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.9|3.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||3.2|-0.9|
91526184|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|||||TWO_SIDED|95.0|-6.8|-2.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||-2.7|-6.8|
91526185|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|3.8|8.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||8.0|3.8|
91670952|NCT00317642|183237128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.0022||95.0|0.4|0.83|||Log Rank|Comparison p-value is from a log-rank test with no strata.||Participants stratified by randomization strata CR1 \>=6 months||0.83|0.40|0.0022
91670953|NCT00317642|183237129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8209|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||Full Analysis Set (FAS) population||1.23|0.77|0.8209
91670954|NCT00317642|183237129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5071|TWO_SIDED|95.0|0.81|1.53|||Log Rank|||||1.53|0.81|0.5071
91526186|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-1.0|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||4.8|-1.0|
91526187|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-9.0|-3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||-3.3|-9.0|
91526188|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|5.1|10.9|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||10.9|5.1|
91526189|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-1.3|8.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||8.1|-1.3|
91526190|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|||||TWO_SIDED|95.0|-12.9|-3.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||-3.5|-12.9|
91526191|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|7.0|16.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||16.5|7.0|
91526192|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-2.6|18.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||18.3|-2.6|
91526193|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-24.7|-3.6|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||-3.6|-24.7|
91526194|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|11.5|32.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||32.2|11.5|
91526195|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.6|1.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||1.0|-1.6|
91526196|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.2|2.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||2.1|-2.2|
91526197|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-2.9|3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||3.3|-2.9|
91637227|NCT03091920|183166565|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|2.64|||TWO_SIDED|95.0|-8.79|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.14|-8.79|
91637228|NCT03091920|183166565|OTHER|No statistical testing was performed.|Least squares mean difference|-1.74|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-7.14|3.67|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.67|-7.14|
91670955|NCT00317642|183237129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2906|TWO_SIDED|95.0|0.59|1.17|||Log Rank|||||1.17|0.59|0.2906
91670956|NCT00317642|183237130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||Full Analysis Set (FAS) population.||0.79|0.49|<.0001
91526198|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||5.7|-3.9|
91526199|NCT01872910|182927295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-6.8|15.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||15.0|-6.8|
91526200|NCT01872910|182927296|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.85|||||TWO_SIDED|95.0|0.99|3.46|||||Hazard ratio (HR) of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.46|0.99|
91526201|NCT01872910|182927296|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.34|||||TWO_SIDED|95.0|0.16|0.72|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.72|0.16|
91526202|NCT01872910|182927296|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|5.48|||||TWO_SIDED|95.0|2.69|11.16|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||11.16|2.69|
91526203|NCT01872910|182927296|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.57|2.59|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||2.59|0.57|
91526204|NCT01872910|182927297|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78|||||TWO_SIDED|95.0|0.41|1.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||1.47|0.41|
91526205|NCT01872910|182927297|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.15|||||TWO_SIDED|95.0|1.19|3.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.88|1.19|
91526206|NCT01872910|182927297|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.36|||||TWO_SIDED|95.0|0.19|0.67|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.67|0.19|
91637229|NCT03091920|183166565|OTHER|No statistical testing was performed.|Least squares mean difference|-1.88|STANDARD_ERROR_OF_MEAN|3.22|||TWO_SIDED|95.0|-8.58|4.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||4.83|-8.58|
91637230|NCT03091920|183166565|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-10.69|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.10|-10.69|
91637231|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-4.45|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-11.3|2.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-11.30|
91670957|NCT00317642|183237130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0486|TWO_SIDED|95.0|0.53|1.01|||Log Rank|||||1.01|0.53|0.0486
91670958|NCT00317642|183237130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||||0.74|0.37|0.0002
91485293|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.25||||0.4063||95.0|-0.84|0.34||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is bedtime profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.34|-0.84|0.4063
91485294|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.2198||95.0|-0.18|0.79||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is 2.00 - 4.00 a.m. profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.79|-0.18|0.2198
91792758|NCT02751931|183463227|OTHER||Mean Difference (Net)|-1.86||||0.011|TWO_SIDED|95.0|-3.27|-0.45||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-0.45|-3.27|0.011
91485295|NCT01278160|182843877|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.04||||0.8424||95.0|-0.47|0.38|||Mixed Models Analysis||Confidence interval is before breakfast the following day profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.38|-0.47|0.8424
91485296|NCT01278160|182843878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7312||95.0|0.36|2.06|||Regression, Logistic||The odds ratio and 95% confidence interval for the HbA1c below 7% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||2.06|0.36|0.7312
91485297|NCT01278160|182843879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.1257||95.0|0.05|1.44|||Regression, Logistic|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate|The odds ratio and 95% confidence interval for the HbA1c below or equal to 6.5% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||1.44|0.05|0.1257
91485298|NCT01278160|182843880|SUPERIORITY_OR_OTHER||Rate ratio|0.72||||0.1911||95.0|0.43|1.18|||Negative binomial regression model||For all episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.18|0.43|0.1911
91485299|NCT01278160|182843880|SUPERIORITY_OR_OTHER||Rate ratio|1.61||||0.2949||95.0|0.66|3.92|||Negative binomial regression model||For nocturnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||3.92|0.66|0.2949
91485300|NCT01278160|182843880|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077||95.0|0.38|1.05|||Negative binomial regression model||For diurnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.05|0.38|0.0770
91485301|NCT01278160|182843880|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.1687||95.0|0.25|1.27|||Negative binomial regression model||For minor episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.27|0.25|0.1687
91485302|NCT02979197|182843881|NON_INFERIORITY|A two-sample t-test was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib (arm 1) was non-inferior to half of the effect achieved with Amlodipine+Placebo (arm 2). The primary efficacy endpoint was considered met if the lower limits of the 97.5% one-side confidence interval (CI) for the difference in SBPday change in arm 1 and 50% of the mean change in arm 2 was less than 0.||||||0.024|||||||t-test, 2 sided|||LOCF method was used. Primary efficacy analysis was based on the difference between the Amlodipine+Celecoxib and Amlodipine+Placebo (arms 1 and 2, respectively) in the mean change in SBPday from Baseline to final (Day 13), where a subject completed the 14-day treatment plan, or to Day 6, where a subject was withdrawn from treatment before the Day 13 dose but after the Day 6 dose, or to baseline, where a subject was withdrawn before the Day 6 dose.||||0.024
91485303|NCT02979197|182843882|OTHER|ANOVA F-test was used to compare the mean changes in body weight from baseline to end of treatment among the three treatment arms. The omni-bus test was to conclude if any differences existed.||||||0.006|||||||ANOVA|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in body weight was the 1st of the four secondary efficacy endpoints.||||0.006
91526207|NCT01872910|182927298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.33|||||TWO_SIDED|95.0|0.12|0.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.88|0.12|
91670959|NCT00317642|183237131|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population||||<0.0001
91526208|NCT01872910|182927298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|4.16|||||TWO_SIDED|95.0|2.04|8.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||8.47|2.04|
91526209|NCT01872910|182927298|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.08|||||TWO_SIDED|95.0|0.03|0.21|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.21|0.03|
91526210|NCT02387216|182927324|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.2302|TWO_SIDED|95.0|0.813|2.35|||Log Rank|||||2.350|0.813|0.2302
91526211|NCT02387216|182927325|SUPERIORITY||Hazard Ratio (HR)|1.195||||0.5436|TWO_SIDED|95.0|0.673|2.122|||Log Rank|||||2.122|0.673|0.5436
91526212|NCT02387216|182927326|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0455|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0455
91526213|NCT02387216|182927327|SUPERIORITY|||||||0.2726|||||||Log Rank|||||||0.2726
91526214|NCT02091739|182927331|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.031|=|0.004|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units versus (v) Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.03|-0.15|= 0.004
91526215|NCT02091739|182927331|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.542|TWO_SIDED|95.0|-0.08|0.04|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.04|-0.08|= 0.542
91526216|NCT02091739|182927332|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.183|=|0.002|TWO_SIDED|95.0|0.22|0.94|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.94|0.22|= 0.002
91670960|NCT00317642|183237131|SUPERIORITY_OR_OTHER|||||||0.0088||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \<6 months.||||0.0088
91670961|NCT00317642|183237131|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \>=6 months||||0.0017
91670962|NCT00317642|183237132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91526217|NCT02091739|182927332|SUPERIORITY||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.181|=|0.055|TWO_SIDED|95.0|-0.01|0.71|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.71|-0.01|= 0.055
91526218|NCT00576732|182927361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-12.19|-3.52||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|"A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.~A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required."||-3.52|-12.19|<0.001
91526219|NCT00576732|182927361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|2.17||0.164|TWO_SIDED|95.0|-7.36|1.27||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||1.27|-7.36|0.164
91526220|NCT00576732|182927362|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.004
91670963|NCT00317642|183237132|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact|||||||0.0506
91670964|NCT00317642|183237132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91526221|NCT00576732|182927362|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.817
91526222|NCT00576732|182927363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.02|-0.33||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|||-0.33|-1.02|<0.001
91670965|NCT00880087|183237145|SUPERIORITY||Risk Difference (RD)|-2.6||||0.63|TWO_SIDED|95.0|-14.5|9.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||9.2|-14.5|0.63
91670966|NCT00880087|183237146|SUPERIORITY||Risk Difference (RD)|2.8||||0.56|TWO_SIDED|95.0|-8.0|13.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||13.7|-8.0|0.56
91670967|NCT00880087|183237147|SUPERIORITY|||||||0.7|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.70
91792759|NCT02751931|183463227|OTHER||Mean Difference (Net)|-0.77||||0.359|TWO_SIDED|95.0|-2.49|0.94||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.94|-2.49|0.359
91792760|NCT02751931|183463228|OTHER||Mean Difference (Net)|-12.38|||<|0.001|TWO_SIDED|95.0|-18.56|-6.21||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||-6.21|-18.56|<0.001
91526223|NCT00576732|182927363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.769|TWO_SIDED|95.0|-0.39|0.29||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||0.29|-0.39|0.769
91526224|NCT00576732|182927364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||<0.001
91526225|NCT00576732|182927364|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.985
91526226|NCT00085202|182927404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8001||95.0|||||Log Rank|||||||0.8001
91526227|NCT00085202|182927404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||95.0|||||Log Rank|||||||0.5195
91526228|NCT00085202|182927404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7696||95.0|||||Log Rank|||||||0.7696
91526229|NCT00085202|182927405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Log Rank|||||||0.0206
91526230|NCT00085202|182927407|SUPERIORITY|||||||0.6231|||||||t-test, 2 sided|||Change over time||||0.6231
91526231|NCT00085202|182927407|SUPERIORITY|||||||0.572|||||||t-test, 2 sided|||Baseline||||0.5720
91526232|NCT02081950|182927415|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|93.65|||||TWO_SIDED|90.0|87.56|100.16||||||||100.16|87.56|
91526233|NCT02081950|182927416|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|100.46|||||TWO_SIDED|90.0|95.74|105.42||||||||105.42|95.74|
91526234|NCT02081950|182927417|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|101.16|||||TWO_SIDED|90.0|96.32|106.24||||||||106.24|96.32|
91526235|NCT02081950|182927418|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|94.88|||||TWO_SIDED|90.0|88.49|101.73||||||||101.73|88.49|
91526236|NCT02081950|182927419|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|97.13|||||TWO_SIDED|90.0|89.93|104.91||||||||104.91|89.93|
91526237|NCT02081950|182927420|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|108.84|||||TWO_SIDED|90.0|95.61|123.91||||||||123.91|95.61|
91526238|NCT02081950|182927431|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|102.45|||||TWO_SIDED|90.0|96.31|109.0||||||||109.0|96.31|
91526239|NCT02081950|182927432|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|95.84|||||TWO_SIDED|90.0|79.11|116.11||||||||116.11|79.11|
91526240|NCT02081950|182927434|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|99.54|||||TWO_SIDED|90.0|95.69|103.54||||||||103.54|95.69|
91526241|NCT02081950|182927438|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|98.36|||||TWO_SIDED|90.0|95.31|101.51||||||||101.51|95.31|
91526242|NCT02081950|182927439|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|111.3|||||TWO_SIDED|90.0|99.73|124.2||||||||124.2|99.73|
91526243|NCT02081950|182927442|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|98.7|||||TWO_SIDED|90.0|93.16|104.57||||||||104.57|93.16|
91526244|NCT02081950|182927443|OTHER||geometric least square mean ratio|103.43|||||TWO_SIDED|90.0|94.5|113.2||||||||113.2|94.5|
91526245|NCT02081950|182927444|OTHER||geometric least square mean ratio|92.92|||||TWO_SIDED|90.0|80.58|107.16||||||||107.16|80.58|
91526246|NCT00110890|182927452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.72|13.36|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||13.36|5.72|<0.001
91526247|NCT00110890|182927453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.38|14.19|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||14.19|5.38|<0.001
91526248|NCT00110890|182927454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11|||<|0.001||95.0|2.0|4.84|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||4.84|2.00|<0.001
91526249|NCT00110890|182927455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.93|||<|0.001||95.0|4.65|10.34|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||10.34|4.65|<0.001
91670968|NCT00880087|183237148|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.46
91792761|NCT02751931|183463228|OTHER||Mean Difference (Net)|-6.48||||0.334|TWO_SIDED|95.0|-20.09|7.13||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||7.13|-20.09|0.334
91715305|NCT01691378|183321726|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.13|TWO_SIDED|95.0|-1.7|12.9|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BDI compared bet arms controlling for T1 BDI. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BDI as function of arm \& T1 BDI. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||12.9|-1.7|.13
91715306|NCT01691378|183321726|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.003|TWO_SIDED|95.0|-13.8|-3.6|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-3.6|-13.8|.003
91715307|NCT01691378|183321726|SUPERIORITY||Mean Difference (Final Values)|-11.6||||0.002|TWO_SIDED|95.0|-18.0|-5.3|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-5.3|-18.0|.002
91715308|NCT04235504|183321754|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1|||linear mixed model|||||-1.10|-1.74|<0.0001
91715309|NCT04235504|183321755|SUPERIORITY||Mean Difference (Final Values)|27.59|||<|0.0001|TWO_SIDED|95.0|21.59|33.6|||linear mixed model|||||33.60|21.59|<0.0001
91715310|NCT04235504|183321756|SUPERIORITY||Mean Difference (Final Values)|-27.86|||<|0.0001|TWO_SIDED|95.0|-34.16|-21.55|||linear mixed model|||||-21.55|-34.16|<0.0001
91715311|NCT04235504|183321757|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6227|TWO_SIDED|95.0|-0.37|0.61|||linear mixed model|||||0.61|-0.37|0.6227
91485304|NCT02979197|182843883|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered SBP24h to a greater degree than Amlodipine+Placebo.||||||0.826|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in SBP24h was the 2nd of the four secondary efficacy endpoints.||||0.826
91715312|NCT04235504|183321758|SUPERIORITY||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-2.17|0.0||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.00|-2.17|
91526250|NCT00110890|182927456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.002||95.0|1.26|2.81|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||2.81|1.26|0.002
91792762|NCT02751931|183463228|OTHER||Mean Difference (Net)|-18.11|||<|0.001|TWO_SIDED|95.0|-24.87|-11.35||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-11.35|-24.87|<0.001
91637232|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-5.17|STANDARD_ERROR_OF_MEAN|3.34|||TWO_SIDED|95.0|-12.1|1.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.75|-12.10|
91715313|NCT04235504|183321759|SUPERIORITY||Mean Difference (Final Values)|28.81|||||TWO_SIDED|95.0|12.34|45.28||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||45.28|12.34|
91715314|NCT04235504|183321760|SUPERIORITY||Mean Difference (Final Values)|-28.45|||||TWO_SIDED|95.0|-45.27|-11.64||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||-11.64|-45.27|
91715315|NCT04235504|183321761|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.32|0.59||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.59|-1.32|
91715316|NCT02002871|183321772|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.||||0.0152
91715317|NCT03652818|183321795|SUPERIORITY||Least Square (LS) Mean Difference|-25.2868|STANDARD_ERROR_OF_MEAN|16.1594|||ONE_SIDED|90.0||-4.421|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group B||-4.4210||
91715318|NCT03652818|183321795|SUPERIORITY||LS Mean Difference|-0.2756|STANDARD_ERROR_OF_MEAN|16.3283|||ONE_SIDED|90.0||20.8083|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group B||20.8083||
91715319|NCT03652818|183321795|SUPERIORITY||LS Mean Difference|-65.9241|STANDARD_ERROR_OF_MEAN|17.2146|||ONE_SIDED|90.0||-43.6959|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group A||-43.6959||
91715320|NCT03652818|183321795|SUPERIORITY||LS Mean Difference|-65.6486|STANDARD_ERROR_OF_MEAN|16.8753|||ONE_SIDED|90.0||-43.8584|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group B vs. Group A||-43.8584||
91715321|NCT03652818|183321795|SUPERIORITY||LS Mean Difference|-90.9353|STANDARD_ERROR_OF_MEAN|17.1044|||ONE_SIDED|90.0||-68.8494|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group A||-68.8494||
91715322|NCT03652818|183321795|SUPERIORITY||LS Mean Difference|-25.0112|STANDARD_ERROR_OF_MEAN|16.5376|||ONE_SIDED|90.0||-3.6571|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group C||-3.6571||
91670969|NCT01002794|183237150|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Power calculation: The sample size calculation was based on the change in KOOS4 from baseline to two year follow-up. To detect a 10 point difference with a standard deviation of 15, with a level of power of 90%, level of significance of 0.05, and an estimated 15% dropout rate at two years, we determined that we would need 56 participants in each group. To allow for a 20% crossover rate, we randomised 140 participants.||||<0.05
91670970|NCT01005329|183237186|OTHER||||||||||||||||||The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|||
91670971|NCT00572039|183237200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.079||||0.47|TWO_SIDED|95.0|-0.14|0.29|||ANCOVA|||To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.||0.29|-0.14|.47
91670972|NCT00572039|183237201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.96|2.77|||ANCOVA|||To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.||2.77|-1.96|.7
91670973|NCT02147587|183237204|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.213|||||TWO_SIDED|80.0|1.033|1.424|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 4|Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)||1.424|1.033|
91670974|NCT02147587|183237205|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.03|||||TWO_SIDED|80.0|0.877|1.209|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Day 1|GMFR for Tofacitinib versus Placebo (Day 1)||1.209|0.877|
91670975|NCT02147587|183237205|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.093|||||TWO_SIDED|80.0|0.924|1.294|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 12|GMFR for Tofacitinib versus Placebo (Week 12)||1.294|0.924|
91670976|NCT02147587|183237206|SUPERIORITY_OR_OTHER||Ratio of GMT|1.063|||||TWO_SIDED|80.0|0.821|1.375|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Day 1|Geometric Mean Titer (GMT) for Tofacitinib versus Placebo (Day 1)||1.375|0.821|
91670977|NCT02147587|183237206|SUPERIORITY_OR_OTHER||Ratio of GMT|1.251|||||TWO_SIDED|80.0|0.967|1.618|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 4|GMT for Tofacitinib versus Placebo (Week 4)||1.618|0.967|
91670978|NCT02147587|183237206|SUPERIORITY_OR_OTHER||Ratio of GMT|1.121|||||TWO_SIDED|80.0|0.862|1.459|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 12|GMT for Tofacitinib versus Placebo (Week 12)||1.459|0.862|
91670979|NCT02147587|183237207|SUPERIORITY_OR_OTHER||Difference in percentages|8.39|||||TWO_SIDED|80.0|-4.05|20.56|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Day 1)||20.56|-4.05|
91670980|NCT02147587|183237207|SUPERIORITY_OR_OTHER||Difference in percentages|14.01|||||TWO_SIDED|80.0|1.57|26.03|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 4)||26.03|1.57|
91670981|NCT02147587|183237207|SUPERIORITY_OR_OTHER||Difference in percentages|2.65|||||TWO_SIDED|80.0|-10.66|15.83|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 12)||15.83|-10.66|
91670982|NCT01315028|183237222|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
91670983|NCT01315028|183237223|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANOVA|||Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.||||0.996
91670984|NCT01315028|183237224|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91670985|NCT01315028|183237225|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91670986|NCT00436917|183237251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Kruskal-Wallis|||A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.||||0.01
91670987|NCT02438540|183237267|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670988|NCT02438540|183237268|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670989|NCT02438540|183237269|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670990|NCT02438540|183237270|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670991|NCT02438540|183237271|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|90.0|||||ANOVA|||||||0.04
91670992|NCT02438540|183237272|NON_INFERIORITY_OR_EQUIVALENCE|multiple comparatives||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
91670993|NCT02438540|183237272|NON_INFERIORITY_OR_EQUIVALENCE|from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
91670994|NCT02438540|183237272|NON_INFERIORITY_OR_EQUIVALENCE|from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
91670995|NCT02438540|183237273|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91526251|NCT01975220|182927465|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.98|STANDARD_DEVIATION|5.4|<|0.0001|TWO_SIDED|90.0|97.275|102.751|||ANOVA||Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).|||102.751|97.275|<0.0001
91670996|NCT02438540|183237274|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670997|NCT02438540|183237275|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670998|NCT02438540|183237276|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91670999|NCT02438540|183237277|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91526252|NCT01975220|182927465|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|97.09|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|90.0|93.857|100.436|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.436|93.857|<0.0001
91637233|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-5.23|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-12.87|2.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||2.42|-12.87|
91637234|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-8.22|STANDARD_ERROR_OF_MEAN|3.58|||TWO_SIDED|95.0|-15.64|-0.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||-0.79|-15.64|
91637235|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.29|0.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.86|-14.29|
91637236|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-3.14|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-10.66|4.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||4.38|-10.66|
91637237|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-4.71|5.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||5.45|-4.71|
91637238|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|-4.94|4.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16||4.91|-4.94|
91637239|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-2.33|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|-10.07|5.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.41|-10.07|
91637240|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-2.45|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-10.26|5.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.37|-10.26|
91637241|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-6.62|5.13|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.13|-6.62|
91637242|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.83|4.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.58|-6.83|
91637243|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-5.13|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-10.72|0.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||0.47|-10.72|
91637244|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|95.0|-9.29|2.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.01|-9.29|
91637245|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-3.92|STANDARD_ERROR_OF_MEAN|3.52|||TWO_SIDED|95.0|-11.22|3.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.38|-11.22|
91637246|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-2.46|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-9.54|4.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||4.63|-9.54|
91637247|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-10.9|1.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||1.39|-10.90|
91637248|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-1.25|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.35|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||4.85|-7.35|
91637249|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-8.57|4.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.35|-8.57|
91637250|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-6.21|6.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||6.31|-6.21|
91671000|NCT02438540|183237278|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671001|NCT02438540|183237279|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671002|NCT02438540|183237280|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671003|NCT02438540|183237281|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671004|NCT02438540|183237282|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671005|NCT02438540|183237283|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671006|NCT02438540|183237284|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
91671007|NCT00373425|183237297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3235|TWO_SIDED|95.0|0.741|1.104||If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.|Log Rank||Hazard ratio: erlotinib to placebo|The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.||1.104|0.741|0.3235
91671008|NCT00373425|183237302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.562|TWO_SIDED|95.0|0.78|1.144|||Log Rank|||The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.||1.144|0.780|0.5620
91671009|NCT00551616|183237320|OTHER||% of observed pregnancies|1.78|||<|0.001|TWO_SIDED|95.0|1.04|2.98|||Chi-squared||Expected pregnancy rate = 5.58%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||2.98|1.04|<0.001
91671010|NCT00551616|183237320|OTHER||% of observed pregnancies|2.59|||<|0.001|TWO_SIDED|95.0|1.68|3.94|||Chi-squared||Expected pregnancy rate = 5.43%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||3.94|1.68|<0.001
91671011|NCT03297294|183237339|SUPERIORITY|at week 12|least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.101|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA|||||0.1|-1.4|0.101
91671012|NCT03297294|183237340|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.168|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|||At week 12||0.2|-1.3|0.168
91671013|NCT03297294|183237344|SUPERIORITY||Odds Ratio (OR)|1.6||||0.255|TWO_SIDED|95.0|0.7|3.9|||Regression, Logistic|||Week 12||3.9|0.7|0.255
91671014|NCT03297294|183237345|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1|TWO_SIDED|95.0|0.8|9.6|||Regression, Logistic|||||9.6|0.8|0.100
91527852|NCT06173570|182930693|SUPERIORITY||Mean Difference (Net)|-6.23||||0.278|TWO_SIDED|95.0|-17.5|5.03|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||5.03|-17.50|0.278
91671015|NCT03314662|183237414|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio (aTIV/aQIV)|1.16|||||TWO_SIDED|95.0|1.05|1.27|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - for strain A/H1N1||1.27|1.05|
91671016|NCT03314662|183237414|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio: (aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log 10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N2||1.09|0.90|
91671017|NCT03314662|183237414|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata||1.08|0.90|
91671018|NCT03314662|183237414|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: (aTIV/aQIV)]|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria||1.08|0.89|
91671019|NCT03314662|183237415|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|3.23|||||TWO_SIDED|95.0|-1.3|7.76||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H1N1||7.76|-1.30|
91671020|NCT03314662|183237415|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|0.37|||||TWO_SIDED|95.0|-4.23|4.96||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H3N2||4.96|-4.23|
91671021|NCT03314662|183237415|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)]|-0.93|||||TWO_SIDED|95.0|-5.13|3.27||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata||3.27|-5.13|
91671022|NCT03314662|183237415|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|Other [SCR difference (aTIV minus aQIV)]|-1.26|||||TWO_SIDED|95.0|-5.07|2.55||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria||2.55|-5.07|
91485305|NCT02979197|182843884|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered DBP24h to a greater degree than Amlodipine+Placebo.||||||0.5|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in DBP24h was the 3rd of the 4 secondary efficacy endpoints.||||0.500
91485306|NCT02979197|182843885|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib improved creatinine clearance to a greater degree than Amlodipine+Placebo.||||||0.668|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in creatinine clearance was the 4th of 4 secondary efficacy endpoints.||||0.668
91485307|NCT02979197|182843886|SUPERIORITY|Differences in the occurrence of TEAEs between treatment arms were evaluated using Chi-square test.||||||0.675|||||||Chi-squared|Computed on the number of subjects who had at least one TEAE.||||||0.675
91485308|NCT02979197|182843886|SUPERIORITY|||||||0.555|||||||Regression, Logistic|TEAE (1=at least one TEAE occurred for the subject; 0=otherwise) as dependent variable and treatment as fixed effect.||||||0.555
91485309|NCT02979197|182843887|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification were treated as 0.||||0.226
91485310|NCT02979197|182843888|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification (BLQ) were treated as 0.04 ng/mL. Assignment of BLQ values to a nonzero number allowed computation of the log transformation. The selection of 0.04 ng/mL was based on the lower limit of quantification of the validated bioanalytical method (0.05 ng/mL) and selecting the next lowest number at the hundredth decimal place.||||0.215
91485311|NCT02979197|182843889|SUPERIORITY|||||||0.0005|||||||ANCOVA|Adjusted mean = -3.48 μmol/L; 95% confidence interval = -5.4 to -1.6||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Celecoxib arm from baseline to Day 14.||||0.0005
91485312|NCT02979197|182843889|SUPERIORITY|||||||0.075|||||||ANCOVA|Adjusted mean = -1.72 μmol/L; 95% confidence interval = -3.6 to 0.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Placebo arm from baseline to Day 14.||||0.0750
91485313|NCT02979197|182843889|SUPERIORITY|||||||0.4184|||||||ANCOVA|Adjusted mean = -1.92 μmol/L; 95% confidence interval = -6.6 to 2.8||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Placebo+Placebo arm from baseline to Day 14.||||0.4184
91526253|NCT01975220|182927465|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|100.7|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.28|103.18|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.18|98.28|<0.0001
91485314|NCT02979197|182843889|SUPERIORITY|||||||0.2022|||||||ANCOVA|Adjusted mean = -1.76 μmol/L; 95% confidence interval = -4.5 to 1.0||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Amlodipine+Placebo arms.||||0.2022
91485315|NCT02979197|182843889|SUPERIORITY|||||||0.541|||||||ANCOVA|Adjusted mean = -1.56 μmol/L; 95% confidence interval = -6.6 to 3.5||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Placebo+Placebo arms.||||0.5410
91485316|NCT02979197|182843889|SUPERIORITY|||||||0.9397|||||||ANCOVA|Adjusted mean = 0.19 μmol/L; 95% confidence interval = -4.9 to 5.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Placebo and Placebo+Placebo arms.||||0.9397
91485317|NCT01193660|182843929|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.59|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91485318|NCT01193660|182843930|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|3.94|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91485319|NCT01193660|182843931|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.7|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91792763|NCT02751931|183463228|OTHER||Mean Difference (Net)|-13.19||||0.005||95.0|-22.02|-4.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||-4.36|-22.02|0.005
91715323|NCT03652818|183321795|SUPERIORITY||LS Mean Difference|10.9546|STANDARD_ERROR_OF_MEAN|21.0237|||ONE_SIDED|90.0||38.1014|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group E vs. Group D||38.1014||
91715324|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|33.6821|STANDARD_ERROR_OF_MEAN|20.1209|||ONE_SIDED|90.0|7.7011||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group B|||7.7011|
91715325|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|6.1658|STANDARD_ERROR_OF_MEAN|20.3312|||ONE_SIDED|90.0|-20.0868||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group B|||-20.0868|
91715326|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|77.3395|STANDARD_ERROR_OF_MEAN|21.4347|||ONE_SIDED|90.0|49.662||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group A|||49.6620|
91792764|NCT02751931|183463229|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
91792765|NCT02751931|183463229|OTHER|||||||0.148||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.148
91526254|NCT01975220|182927466|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|94.65|STANDARD_DEVIATION|28.1||0.0256|TWO_SIDED|90.0|82.29|108.88|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||108.88|82.29|0.0256
91526255|NCT01975220|182927466|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.69|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.25|103.26|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.26|96.25|<0.0001
91526256|NCT01975220|182927466|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.76|STANDARD_DEVIATION|24.2||0.002|TWO_SIDED|90.0|88.65|112.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||112.27|88.65|0.0020
91526257|NCT01975220|182927467|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.1|STANDARD_DEVIATION|5.1|<|0.0001|TWO_SIDED|90.0|97.555|102.719|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||102.719|97.555|<0.0001
91526258|NCT01975220|182927467|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.01|STANDARD_DEVIATION|7.0|<|0.0001|TWO_SIDED|90.0|93.622|100.531|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.531|93.622|<0.0001
91526259|NCT01975220|182927467|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.78|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.36|103.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.27|98.36|<0.0001
91526260|NCT01975220|182927468|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|109.07|STANDARD_DEVIATION|17.4||0.0072|TWO_SIDED|90.0|99.892|119.1|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||119.100|99.892|0.0072
91792766|NCT02751931|183463229|OTHER|||||||0.002||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||0.002
91715327|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|71.1737|STANDARD_ERROR_OF_MEAN|21.0123|||ONE_SIDED|90.0|44.0417||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group B vs. Group A|||44.0417|
91715328|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|104.8558|STANDARD_ERROR_OF_MEAN|21.2975|||ONE_SIDED|90.0|77.3555||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group A|||77.3555|
91715329|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|27.5163|STANDARD_ERROR_OF_MEAN|20.5918|||ONE_SIDED|90.0|0.9272||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group C|||0.9272|
91715330|NCT03652818|183321796|SUPERIORITY||LS Mean Difference|-30.1223|STANDARD_ERROR_OF_MEAN|26.1776|||ONE_SIDED|90.0|-63.924||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group E vs. Group D|||-63.9240|
91715331|NCT01868646|183321821|SUPERIORITY|||||||0.0002||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0002
91792767|NCT02751931|183463229|OTHER|||||||0.039||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||0.039
91792768|NCT02751931|183463230|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
91792769|NCT02751931|183463230|OTHER|||||||0.007||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.007
91671023|NCT03314662|183237418|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the Full Analysis Set (FAS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22.|GMT ratio|0.64|||||TWO_SIDED|95.0|0.58|0.7||||||B/Yamagata strain: GMT Ratio (aTIV/aQIV)||0.70|0.58|
91671024|NCT03314662|183237418|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the FAS Immunogenicity.|GMT ratio|0.71|||||TWO_SIDED|95.0|0.64|0.78||||||B/Victoria Strain: GMT Ratio (aTIV/aQIV)||0.78|0.64|
91671025|NCT03314662|183237421|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-11.96|||||TWO_SIDED|95.0|-15.12|-8.81||||||B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV).||-8.81|-15.12|
91671026|NCT03314662|183237421|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-10.82|||||TWO_SIDED|95.0|-13.54|-8.11||||||B/Victoria Strain: SCR Difference (aTIV-2 - aQIV)||-8.11|-13.54|
91671027|NCT01117766|183237427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.537||0.7319|TWO_SIDED|95.0|-1.29|0.92|||ANCOVA|||Week 3 (Visits 3 and 6)||0.92|-1.29|0.7319
91671028|NCT01117766|183237427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.536||0.3404|TWO_SIDED|95.0|-1.61|0.57|||ANCOVA|||Week 4 (Visits 4 and 7)||0.57|-1.61|0.3404
91671029|NCT01117766|183237428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|STANDARD_ERROR_OF_MEAN|26.872||0.6539|TWO_SIDED|95.0|-70.2|45.56|||ANCOVA|||Week 3 (Visits 3 and 6)||45.56|-70.20|0.6539
91485320|NCT01193660|182843933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||The baseline and post-therapy data of each group were compared using paired t-test statistics.|t-test, 2 sided|Voxels with an uncorrected p-value of \<0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.||In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.||||0.05
91485321|NCT01193660|182843935|SUPERIORITY_OR_OTHER_LEGACY||interaction of group and visit|0.9|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91485322|NCT01193660|182843936|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|1.279|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91485323|NCT01193660|182843937|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.996|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91485324|NCT01193660|182843938|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.56|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
91485325|NCT01193660|182843939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Fisher Exact|We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.||||||<0.05
91485326|NCT01886716|182843940|SUPERIORITY_OR_OTHER||Slope|-0.8|STANDARD_ERROR_OF_MEAN|0.95|=|0.4|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .71|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training."||||=.40
91485327|NCT01886716|182843940|SUPERIORITY_OR_OTHER||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.95|=|0.78|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .08|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training."||||=.78
91671030|NCT01117766|183237428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.91|STANDARD_ERROR_OF_MEAN|25.807||0.3678|TWO_SIDED|95.0|-78.54|30.72|||ANCOVA|||Week 4 (Visits 4 and 7)||30.72|-78.54|0.3678
91671031|NCT01117766|183237429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.342||0.0071|TWO_SIDED|95.0|-1.84|-0.35|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||-0.35|-1.84|0.0071
91671032|NCT01117766|183237429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.37||0.1294|TWO_SIDED|95.0|-1.36|0.19|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.19|-1.36|0.1294
91671033|NCT01117766|183237430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.54|STANDARD_ERROR_OF_MEAN|25.298||0.03|TWO_SIDED|95.0|-116.12|-6.96|||ANCOVA|||Week 3 (Visits 3 and 6)||-6.96|-116.12|0.0300
91671034|NCT01117766|183237430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.06|STANDARD_ERROR_OF_MEAN|26.501||0.0844|TWO_SIDED|95.0|-105.67|7.55|||ANCOVA|||Week 4 (Visits 4 and 7)||7.55|-105.67|0.0844
91671035|NCT01117766|183237431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.478||0.7506|TWO_SIDED|95.0|-0.83|1.14|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.14|-0.83|0.7506
91671036|NCT01117766|183237431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.299||0.9673|TWO_SIDED|95.0|-0.61|0.64|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.64|-0.61|0.9673
91671037|NCT01117766|183237432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.642||0.5502|TWO_SIDED|95.0|-0.99|1.78|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.78|-0.99|0.5502
91671038|NCT01117766|183237432|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.5||0.8536|TWO_SIDED|95.0|-1.15|0.96|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.96|-1.15|0.8536
91715332|NCT01868646|183321822|SUPERIORITY|||||||0.0426||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0426
91671039|NCT01117766|183237433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.586||0.0132|TWO_SIDED|95.0|-2.73|-0.34|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 3 (Visits 3 and 6)||-0.34|-2.73|0.0132
91792770|NCT02751931|183463230|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||< 0.001
91792771|NCT02751931|183463230|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||< 0.001
91671040|NCT01117766|183237433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.467||0.0403|TWO_SIDED|95.0|-1.95|-0.05|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 4 (Visits 4 and 7)||-0.05|-1.95|0.0403
91671041|NCT01117766|183237434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.433||0.6631|TWO_SIDED|95.0|-1.12|0.74|||ANCOVA|||Week 3 (Visits 3 and 6)||0.74|-1.12|0.6631
91671042|NCT01117766|183237434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.465||0.0022|TWO_SIDED|95.0|-2.48|-0.59|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.59|-2.48|0.0022
91671043|NCT01117766|183237435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.722||0.1753|TWO_SIDED|95.0|-2.6|0.53|||ANCOVA|||Week 3 (Visits 3 and 6)||0.53|-2.60|0.1753
91671044|NCT01117766|183237435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.588||0.0198|TWO_SIDED|95.0|-2.75|-0.27|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.27|-2.75|0.0198
91671045|NCT01117766|183237436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29|STANDARD_ERROR_OF_MEAN|6.292||0.4999|TWO_SIDED|95.0|-17.13|8.54|||ANCOVA|||||8.54|-17.13|0.4999
91671046|NCT05766787|183237440|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||-0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, sequence, visit, and lens by visit interaction) and random (subject) effects. Difference = LID022821 minus AOHG. Sign is retained with the rounded value.|||-0.01||
91671047|NCT00438659|183237441|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
91671048|NCT01867606|183237452|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
91671049|NCT01867606|183237454|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
91671050|NCT01917968|183237471|SUPERIORITY||Adjusted difference in percentages|6.5||||0.056|TWO_SIDED|90.0|-0.2|13.2||Statistical significance is considered at 0.05 level.|Z statistics|P-value is calculated using a Z statistics from the propensity score adjusted estimates. Missing values are handled using multiple imputation.||||13.2|-0.2|0.056
91671051|NCT01917968|183237472|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 298 subjects (149 subjects per arm) are needed to detect non-inferiority with a margin of 10%.|Adjusted difference in percentages|-0.4|||||TWO_SIDED|90.0|-2.7|1.9|||||The propensity score adjusted difference in SAE rate of Uphold LITE transvaginal mesh (TVM) vs. NTR was estimated.|||1.9|-2.7|
91671052|NCT01435928|183237485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.039|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||||0.98|0.45|0.039
91671053|NCT01435928|183237486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.07|TWO_SIDED|95.0|0.54|1.03|||Log Rank|||||1.03|0.54|0.070
91671054|NCT01435928|183237487|SUPERIORITY_OR_OTHER|||||||0.029|||||||ANCOVA|LOCF||||||0.029
91715333|NCT01868646|183321823|SUPERIORITY|||||||0.599||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.5990
91792772|NCT02751931|183463231|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||<0.001
91792773|NCT02751931|183463231|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.006
91792774|NCT02751931|183463231|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||< 0.001
91526261|NCT01975220|182927468|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|92.42|STANDARD_DEVIATION|12.5||0.0004|TWO_SIDED|90.0|86.781|98.428|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||98.428|86.781|0.0004
91526262|NCT01975220|182927468|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|105.37|STANDARD_DEVIATION|17.7||0.0014|TWO_SIDED|90.0|96.6|114.942|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||114.942|96.600|0.0014
91526263|NCT01975220|182927469|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|96.65|STANDARD_DEVIATION|29.8||0.0198|TWO_SIDED|90.0|83.337|112.079|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||112.079|83.337|0.0198
91526264|NCT01975220|182927469|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|110.17|STANDARD_DEVIATION|12.0||0.0007|TWO_SIDED|90.0|103.809|116.926|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||116.926|103.809|0.0007
91526265|NCT01975220|182927469|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.68|STANDARD_DEVIATION|23.8||0.0037|TWO_SIDED|90.0|86.942|109.734|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||109.734|86.942|0.0037
91526266|NCT01975220|182927470|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|95.4|STANDARD_DEVIATION|29.4||0.0254|TWO_SIDED|90.0|82.42|110.44|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||110.44|82.42|0.0254
91526267|NCT01975220|182927470|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|99.63|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.21|103.17|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.17|96.21|<0.0001
91526268|NCT01975220|182927470|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|101.06|STANDARD_DEVIATION|24.4||0.0029|TWO_SIDED|90.0|89.7|113.86|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||113.86|89.70|0.0029
91526269|NCT03245255|182927531|OTHER|Correlation analysis|Pearson Correlation Coefficient|-0.8|STANDARD_DEVIATION|0.1|||TWO_SIDED|||||||||||||
91526270|NCT01008475|182927534|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
91526271|NCT01008475|182927534|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.77|1.61||||||||1.61|0.77|
91526272|NCT01008475|182927535|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.54|1.28||||||||1.28|0.54|
91526273|NCT01008475|182927535|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.52|1.25||||||||1.25|0.52|
91526274|NCT01008475|182927536|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
91526275|NCT01008475|182927536|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
91526276|NCT01008475|182927538|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.67|1.34||||||||1.34|0.67|
91526277|NCT01008475|182927538|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.74|1.48||||||||1.48|0.74|
91526278|NCT01301274|182927539|NON_INFERIORITY_OR_EQUIVALENCE|beta error 20%, alfa error 5%, diminished 2 mEq/L between groups||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
91526279|NCT01301274|182927540|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||without adjust|Chi-squared|||||||0.081
91526280|NCT01301274|182927541|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||||||0.396
91526281|NCT01301274|182927542|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||t-test, 2 sided|||||||0.129
91526282|NCT03021668|182927580|EQUIVALENCE|Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups||||||0.003|||||||Chi-squared|||||||0.003
91526283|NCT03021668|182927581|EQUIVALENCE|Students' T-test was used to evaluate any difference in length of stay between the two groups.||||||0.23|||||||t-test, 2 sided|||||||0.23
91526284|NCT03017235|182927672|NON_INFERIORITY|The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.|Difference in percentage|6.3||||0.0067|TWO_SIDED|95.0|1.8|10.9||The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)|Lower limit of 95% CI \> 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.|10.9|1.8|0.0067
91671055|NCT01435928|183237488|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|LOCF||||||0.015
91792775|NCT02751931|183463231|OTHER|||||||0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||0.001
91526285|NCT03017235|182927673|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|4.6||||0.0099|TWO_SIDED|95.0|1.1|8.0||The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)||8.0|1.1|0.0099
91526286|NCT03017235|182927674|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|1.9||||0.1781|TWO_SIDED|95.0|-0.9|4.7||The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)||4.7|-0.9|0.1781
91526287|NCT03017235|182927675|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.|Difference in percentage|3.5||||0.0391|TWO_SIDED|95.0|0.2|6.7||The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)||6.7|0.2|0.0391
91526288|NCT02444988|182927695|SUPERIORITY||Odds Ratio (OR)|0.87|||<|0.05|TWO_SIDED|95.0|0.77|0.99|||Regression, Logistic|||||0.99|0.77|<0.05
91526289|NCT02444988|182927696|SUPERIORITY||Odds Ratio (OR)|0.84|||<|0.05|TWO_SIDED|95.0|0.73|0.97|||Regression, Logistic|||||0.97|0.73|<0.05
91526290|NCT02105636|182927704|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0101|TWO_SIDED|95.0|0.53|0.92||Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.|Log Rank||Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.|Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)||0.92|0.53|0.0101
91526291|NCT02105636|182927705|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.1|||||Number of responders (CR +PR) over number of participants|||1.10|0.68|
91526292|NCT02105636|182927706|SUPERIORITY||Difference in ORR|7.6|||||TWO_SIDED|95.0|1.5|13.6|||||Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.|||13.6|1.5|
91671056|NCT01435928|183237489|SUPERIORITY_OR_OTHER|||||||0.218|||||||ANCOVA|LOCF||||||0.218
91671057|NCT01435928|183237490|SUPERIORITY_OR_OTHER|||||||0.021|||||||ANCOVA|LOCF||||||0.021
91671058|NCT01435928|183237491|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|LOCF||||||0.056
91671059|NCT02248662|183237512|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Regression, Logistic|Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.|This group is the reference group.|Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||||<0.05
91671060|NCT02248662|183237512|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.05|||<|0.05|TWO_SIDED|95.0|0.71|1.56||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Chi-squared|||Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||1.56|0.71|<0.05
91671061|NCT02248662|183237512|OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.27|2.84|||Chi-squared|||||2.84|1.27|<0.05
91671062|NCT01835548|183237513|SUPERIORITY||Least Square Mean Difference|-11.04|STANDARD_ERROR_OF_MEAN|1.4239|<|0.0001|TWO_SIDED|95.0|-13.9|-8.2|||ANCOVA|||||-8.20|-13.9|<0.0001
91671063|NCT00739973|183237543|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.97|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-12.81|-7.12|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.12|-12.81|<0.001
91671064|NCT00739973|183237544|SUPERIORITY_OR_OTHER||Least Square mean Difference|-4.82|STANDARD_ERROR_OF_MEAN|1.47||0.001|TWO_SIDED|95.0|-7.7|-1.94|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.94|-7.70|0.001
91792776|NCT02751931|183463232|OTHER||Mean Difference (Net)|14.58||||0.035|TWO_SIDED|95.0|1.0|28.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||28.1|1.0|0.035
91526293|NCT02105636|182927706|SUPERIORITY||CMH Estimate of Common Odds Ratio|2.49|||||TWO_SIDED|95.0|1.07|5.82|||||Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.|||5.82|1.07|
91526294|NCT02105636|182927707|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.85|||||Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.|||0.85|0.54|
91526295|NCT02341287|182927743|SUPERIORITY||Mean Difference (Net)|14.01|STANDARD_DEVIATION|19.4||0.023|TWO_SIDED|95.0|2.29|25.74||Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by actigraph.|t-test, 2 sided|||||25.74|2.29|.023
91526296|NCT02341287|182927744|SUPERIORITY|Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by sleep log.|Mean Difference (Net)|13.51|STANDARD_DEVIATION|16.91|<|0.014|TWO_SIDED|95.0|3.29|23.73|||t-test, 2 sided|||||23.73|3.29|<0.014
91526297|NCT02254408|182927745|SUPERIORITY||Treatment Difference|-0.33||||0.04|TWO_SIDED|95.0|-0.64|-0.02|||ANCOVA|||||-0.02|-0.64|0.040
91526298|NCT02254408|182927746|SUPERIORITY||Odds Ratio (OR)|0.5||||0.11|TWO_SIDED|95.0|0.22|1.18|||Cochran-Mantel-Haenszel|||||1.18|0.22|0.11
91526299|NCT02254408|182927746|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
91526300|NCT02254408|182927747|SUPERIORITY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.28|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.28|0.98
91637251|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-6.66|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.22|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.90|-14.22|
91671065|NCT00739973|183237545|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.85|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-16.68|-11.0|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-11.0|-16.68|<0.001
91671066|NCT00739973|183237546|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-16.04|-10.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-10.4|-16.04|<0.001
91671067|NCT00739973|183237547|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.77|-4.22|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.22|-7.77|<0.001
91671068|NCT00739973|183237548|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.91||0.001|TWO_SIDED|95.0|-4.77|-1.19|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.19|-4.77|0.001
91671069|NCT00739973|183237549|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.63|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-10.39|-6.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.87|-10.39|<0.001
91671070|NCT00739973|183237550|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-9.94|-6.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.40|-9.94|<0.001
91671071|NCT00739973|183237551|SUPERIORITY_OR_OTHER||Least Sqaure Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.92||0.011|TWO_SIDED|95.0|-4.14|-0.53|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.53|-4.14|0.011
91671072|NCT00739973|183237552|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.81|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-12.57|-9.05|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.05|-12.57|<0.001
91671073|NCT00739973|183237553|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.56|-3.03|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.03|-6.56|<0.001
91671074|NCT00739973|183237554|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.98|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|-5.78|-2.18|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-2.18|-5.78|<0.001
91671075|NCT00739973|183237555|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-11.41|-7.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.87|-11.41|<0.001
91671076|NCT00739973|183237556|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.26|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-8.0|-4.51|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.51|-8.00|<0.001
91526301|NCT02254408|182927747|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91526302|NCT01993017|182927748|SUPERIORITY|||||||0.98||||||A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value \<.05.|ANOVA|||We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.||||0.98
91526303|NCT00917267|182927752|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is \<0; noninferiority concluded if upper limit is \<0.4%.|Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||Mixed Models Analysis|||MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.14|-0.49|<.001
91637252|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-6.38|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-14.01|1.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||1.25|-14.01|
91792777|NCT02751931|183463232|OTHER||Mean Difference (Net)|35.99||||0.003|TWO_SIDED|95.0|13.1|58.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||58.9|13.1|0.003
91526304|NCT00917267|182927753|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.||||0.003
91526305|NCT00917267|182927754|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.||||<.001
91526306|NCT00917267|182927755|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.67|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-22.5|-10.83|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||-10.83|-22.50|<.001
91526307|NCT00917267|182927756|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.39|1.25|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.25|0.39|<.001
91526308|NCT00917267|182927757|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|2.56||0.609|TWO_SIDED|95.0|-6.33|3.71|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||3.71|-6.33|0.609
91526309|NCT00917267|182927758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.52||0.476|TWO_SIDED|95.0|-0.65|1.38|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.38|-0.65|0.476
91526310|NCT00917267|182927759|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.807|TWO_SIDED|95.0|0.93|1.06|||Mixed Models Analysis|||TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.06|0.93|0.807
91671077|NCT00739973|183237557|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|-4.42|-0.83|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.83|-4.42|0.004
91671078|NCT00739973|183237558|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-12.85|-9.35|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.35|-12.85|<0.001
91671079|NCT00739973|183237559|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.83|STANDARD_ERROR_OF_MEAN|1.48||0.056|TWO_SIDED|95.0|-5.73|-0.07|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.07|-5.73|0.056
91671080|NCT00739973|183237560|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-17.08|STANDARD_ERROR_OF_MEAN|1.44|<|0.001||95.0|-19.91|-14.3|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-14.3|-19.91|<0.001
91671081|NCT00739973|183237561|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.45|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-9.29|-3.62|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.62|-9.29|<0.001
91671082|NCT00739973|183237562|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-8.9|-3.11|||ANCOVA|A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.||||-3.11|-8.90|<0.001
91671083|NCT00739973|183237563|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-15.03|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-17.88|-12.2|||ANCOVA|||||-12.2|-17.88|<0.001
91671084|NCT00739973|183237564|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.82|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-10.63|-5.02|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-5.02|-10.63|<0.001
91671085|NCT00739973|183237565|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|1.47||0.143|TWO_SIDED|95.0|-5.04|0.73|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||0.73|-5.04|0.143
91671086|NCT00739973|183237566|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-19.21|-13.6|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-13.6|-19.21|<0.001
91527853|NCT06173570|182930693|SUPERIORITY||Mean Difference (Net)|-6.87||||0.234|TWO_SIDED|95.0|-18.19|4.45|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||4.45|-18.19|0.234
91671087|NCT03203642|183237606|SUPERIORITY||LS mean difference|-0.0052|STANDARD_ERROR_OF_MEAN|0.0082||0.5265|TWO_SIDED|95.0|-0.0217|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0112|-0.0217|0.5265
91671088|NCT03203642|183237607|SUPERIORITY||LS mean difference|-0.0042|STANDARD_ERROR_OF_MEAN|0.0111||0.7076|TWO_SIDED|95.0|-0.0264|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0180|-0.0264|0.7076
91792778|NCT02751931|183463232|OTHER||Mean Difference (Net)|30.08|||<|0.001|TWO_SIDED|95.0|14.7|45.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||45.5|14.7|<0.001
91792779|NCT02751931|183463232|OTHER||Mean Difference (Net)|51.96|||<|0.001|TWO_SIDED|95.0|24.6|79.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||79.3|24.6|<0.001
91526311|NCT00423293|182927774|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0||||One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).|Chi-squared|||The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 \[NCT00003596\] had a 77% rate of \>= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)||||0.50
91526312|NCT00423293|182927776|SUPERIORITY|||||||0.5|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.5
91526313|NCT00423293|182927776|SUPERIORITY|||||||0.18|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.18
91526314|NCT00423293|182927776|SUPERIORITY|||||||0.032|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.032
91526315|NCT00423293|182927776|SUPERIORITY|||||||0.1|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.10
91526316|NCT00423293|182927776|SUPERIORITY|||||||0.12|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.12
91526317|NCT00423293|182927776|SUPERIORITY|||||||0.23|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.23
91526318|NCT01200030|182927792|OTHER|The effect size of the intervention was adopted from a mate-analysis . The showed an average effect size of 0.59 in improving the motor control of limbs in people with stroke. A sample size for each group was set at 11 . Presuming that there would be a drop-out rate of 10% during the course of study, an extra 1 subject was recruited in each group. the sample size was 36. The statistical significance was set at 5% (alpha \< 0.05) with power equal to 80%|||||<|0.001||||||Post-hoc pairwise comparisons have been conducted. Please refer to subsequent data analyses.|Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.||||<0.001
91526319|NCT01200030|182927792|OTHER|||||||1||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.||||1.00
91526320|NCT01200030|182927792|OTHER|||||||0.002||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.002
91526321|NCT01200030|182927792|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.003
91526322|NCT01200030|182927793|OTHER|||||||0.055|||||||Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.||||0.055
91526323|NCT00872430|182927827|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91526324|NCT00872430|182927828|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.||||<0.001
91792780|NCT02751931|183463232|OTHER||Mean Difference (Net)|36.9|||<|0.001|TWO_SIDED|95.0|22.7|51.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||51.1|22.7|<0.001
91637253|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-9.3|4.71|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.71|-9.30|
91526325|NCT03469349|182927841|SUPERIORITY||Least square mean difference|29.19|STANDARD_ERROR_OF_MEAN|10.083||0.0041|TWO_SIDED|95.0|9.35|49.02|||MMRM|||Least squares means, p-values were obtained using a mixed model for repeated measures (MMRM) analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||49.02|9.35|0.0041
91792781|NCT02751931|183463232|OTHER||Mean Difference (Net)|45.1|||<|0.001|TWO_SIDED|95.0|21.3|68.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||68.9|21.3|<0.001
91792782|NCT02751931|183463232|OTHER||Mean Difference (Net)|32.25|||<|0.001|TWO_SIDED|95.0|18.2|46.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||46.3|18.2|<0.001
91671089|NCT03203642|183237608|SUPERIORITY||LS mean difference|-0.0122|STANDARD_ERROR_OF_MEAN|0.014||0.3895|TWO_SIDED|95.0|-0.0404|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0160|-0.0404|0.3895
91671090|NCT03203642|183237609|SUPERIORITY||LS mean difference|0.0015|STANDARD_ERROR_OF_MEAN|0.0131||0.9093|TWO_SIDED|95.0|-0.0248|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0278|-0.0248|0.9093
91671091|NCT02875028|183237614|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
91671092|NCT05068284|183237626|SUPERIORITY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-6.3|20.6|||||Risk difference = (ABBV-154 - placebo)|||20.6|-6.3|
91671093|NCT05068284|183237626|SUPERIORITY||Risk Difference (RD)|33.3|||||TWO_SIDED|95.0|6.7|60.0|||||Risk difference = (ABBV-154 - placebo)|||60.0|6.7|
91671094|NCT05068284|183237626|SUPERIORITY||Risk Difference (RD)|28.6|||||TWO_SIDED|95.0|4.9|52.2|||||Risk difference = (ABBV-154 - placebo)|||52.2|4.9|
91671095|NCT05068284|183237626|SUPERIORITY||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|1.0|53.6|||||Risk difference = (ABBV-154 - placebo)|||53.6|1.0|
91671096|NCT05068284|183237627|SUPERIORITY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-19.8|43.6|||||Risk difference = (ABBV-154 - placebo)|||43.6|-19.8|
91671097|NCT05068284|183237627|SUPERIORITY||Risk Difference (RD)|29.5|||||TWO_SIDED|95.0|-4.8|63.8|||||Risk difference = (ABBV-154 - placebo)|||63.8|-4.8|
91671098|NCT05068284|183237627|SUPERIORITY||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|-13.7|51.8|||||Risk difference = (ABBV-154 - placebo)|||51.8|-13.7|
91671099|NCT05068284|183237627|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|-13.6|60.3|||||Risk difference = (ABBV-154 - placebo)|||60.3|-13.6|
91671100|NCT05068284|183237628|SUPERIORITY||Risk Difference (RD)|11.3|||||TWO_SIDED|95.0|-18.5|41.0|||||Risk difference = (ABBV-154 - placebo)|||41.0|-18.5|
91792783|NCT02751931|183463232|OTHER||Mean Difference (Net)|43.94||||0.001|TWO_SIDED|95.0|19.2|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|19.2|0.001
91671101|NCT05068284|183237628|SUPERIORITY||Risk Difference (RD)|38.5|||||TWO_SIDED|95.0|5.0|71.9|||||Risk difference = (ABBV-154 - placebo)|||71.9|5.0|
91671102|NCT05068284|183237628|SUPERIORITY||Risk Difference (RD)|24.6|||||TWO_SIDED|95.0|-7.0|56.2|||||Risk difference = (ABBV-154 - placebo)|||56.2|-7.0|
91671103|NCT05068284|183237628|SUPERIORITY||Risk Difference (RD)|39.2|||||TWO_SIDED|95.0|3.8|74.5|||||Risk difference = (ABBV-154 - placebo)|||74.5|3.8|
91792784|NCT02751931|183463232|OTHER||Mean Difference (Net)|41.63|||<|0.001|TWO_SIDED|95.0|23.3|60.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||60.0|23.3|<0.001
91671104|NCT02760264|183237633|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
91671105|NCT02760264|183237635|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
91671106|NCT02760264|183237637|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
91671107|NCT02760264|183237638|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
91671108|NCT02760264|183237640|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
91671109|NCT02760264|183237642|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
91671110|NCT05918822|183237650|OTHER|A mixed-effects model was applied to log (ln)-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as random effect. Point estimates and their associated 90% confidence intervals (CIs) were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimate and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|82.19|||||TWO_SIDED|90.0|74.31|90.91|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||90.91|74.31|
91671111|NCT05918822|183237650|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|57.72|||||TWO_SIDED|90.0|52.18|63.84|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||63.84|52.18|
91671112|NCT05918822|183237650|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|49.03|||||TWO_SIDED|90.0|40.07|60.0|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||60.00|40.07|
91715334|NCT01868646|183321824|SUPERIORITY|||||||0.6215||||||"The p-value associated with treatment factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.6215
91671113|NCT05918822|183237651|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|97.59|||||TWO_SIDED|90.0|91.39|104.2|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||104.20|91.39|
91671114|NCT05918822|183237651|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|82.05|||||TWO_SIDED|90.0|76.84|87.61|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||87.61|76.84|
91671115|NCT05918822|183237651|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|70.0|||||TWO_SIDED|90.0|60.11|81.51|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||81.51|60.11|
91671116|NCT05918822|183237652|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|99.94|||||TWO_SIDED|90.0|94.12|106.11|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||106.11|94.12|
91671117|NCT05918822|183237652|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|81.68|||||TWO_SIDED|90.0|76.93|86.73||||||Comparison of AUC0-infinity of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||86.73|76.93|
91671118|NCT05918822|183237652|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|88.92|||||TWO_SIDED|90.0|76.94|102.78|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||102.78|76.94|
91671119|NCT00988208|183237694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.0017|TWO_SIDED|95.0|1.17|2.0||p-value is based on unstratified log-rank test|Log Rank|||||2.00|1.17|0.0017
91671120|NCT00988208|183237695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.0187|TWO_SIDED|95.0|1.05|1.66|||Log Rank|P-value is based on unstratified log-rank test||||1.66|1.05|0.0187
91671121|NCT00988208|183237696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3975|TWO_SIDED|95.0|0.665|1.176|||Chi-squared|||||1.176|0.665|0.3975
91671122|NCT03008837|183237701|OTHER|Using seed-based analysis with a right posterior insula seed, cluster size was set at 40 voxels, and p-value was thresholded at p\<0.05 to compare the differences between the two groups in terms of connectivity between the right posterior insula and areas of the DMN identified based on a priori hypotheses.|Mean Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided||Standard therapy control (post-pre) was subtracted from PENFS (post-pre).|PENFS (post-pre) - Standard Therapy (post-pre)||||<0.05
91526326|NCT03469349|182927842|SUPERIORITY||Least square mean difference|15.86|STANDARD_ERROR_OF_MEAN|7.814||0.0431|TWO_SIDED|95.0|0.49|31.24|||MMRM|||Week 2: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||31.24|0.49|0.0431
91671123|NCT02000531|183237719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26|||>|0.05|TWO_SIDED|95.0|0.61|2.62|||Log Rank|||||2.62|0.61|>0.05
91671124|NCT01546142|183237739|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.983|||<|0.001|TWO_SIDED|95.0|2.311|3.849|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||3.849|2.311|<0.001
91671125|NCT01546142|183237740|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|6.271|||<|0.001|TWO_SIDED|95.0|2.908|13.52|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||13.520|2.908|<0.001
91526327|NCT03469349|182927842|SUPERIORITY||Least square mean difference|35.51|STANDARD_ERROR_OF_MEAN|12.48||0.0047|TWO_SIDED|95.0|10.96|60.05|||MMRM|||Week 24: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||60.05|10.96|0.0047
91671126|NCT01546142|183237741|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.838|||<|0.001|TWO_SIDED|95.0|3.299|18.622|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||18.622|3.299|<0.001
91671127|NCT01546142|183237742|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
91671128|NCT00255151|183237759|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
91671129|NCT00255151|183237759|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
91671130|NCT00255151|183237759|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
91671131|NCT00255151|183237760|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91671132|NCT00255151|183237760|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91671133|NCT00255151|183237760|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
91526328|NCT03469349|182927843|SUPERIORITY|||||||0.0227|||||||MMRM|||Week 2: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0227
91526329|NCT03469349|182927843|SUPERIORITY|||||||0.0007|||||||MMRM|||Week 12: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0007
91671134|NCT00255151|183237762|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
91671135|NCT00255151|183237762|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
91671136|NCT00255151|183237762|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
91671137|NCT00255151|183237763|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91671138|NCT00255151|183237763|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91671139|NCT00255151|183237763|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
91671140|NCT00934596|183237767|SUPERIORITY_OR_OTHER||Median Difference (Net)|57.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91671141|NCT00934596|183237770|SUPERIORITY_OR_OTHER||Median Difference (Net)|72.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91671142|NCT00934596|183237775|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||As data for these small groups were non-parametric the median and quartiles were used for comparison of groups by the Wilcoxon Rank Sum test.||||<0.001
91671143|NCT01280617|183237805|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Continuous variables analyzed using 2-tailed t test or Mann Whitney tes.. Categorical variables analyzed using Chi-Square or Fisher's Exact test||||||<0.05
91671144|NCT01280617|183237805|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91671145|NCT01311557|183237812|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.843|1.05||||||||1.05|0.843|
91671146|NCT01311557|183237812|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.944|1.13||||||||1.13|0.944|
91671147|NCT01311557|183237812|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.928|1.18||||||||1.18|0.928|
91671148|NCT01311557|183237812|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.|GMT Ratio|0.882|||||TWO_SIDED|95.0|0.731|1.06||||||||1.06|0.731|
91671149|NCT03852524|183237818|SUPERIORITY||Median Difference (Net)|11.0||||0.81|TWO_SIDED||||||Log Rank|||The sample size (41 patients per study group; 82 patients total) for this superiority trial was calculated with a power of 90% (alpha = 0.05) and based on the assumption that 50% of subjects in the placebo group would experience a bowel movement by postoperative day 3, as compared to 85% in the treatment group. Additionally, a 10% lost-to-follow up rate was assumed.||||0.81
91671150|NCT02973321|183237849|OTHER|The overall Type 1 error for multiple comparisons of the HbA1c and body weight was controlled by a Hierarchical testing procedure. Testing was performed in following sequence: 1. 1st trend test for HbA1c, 2. 1st trend test for body weight, 3. 2nd trend test for HbA1c, 4. 2nd trend test for body weight, 5. 3rd trend test for HbA1c, 6. 3rd trend test for body weight.|||||<|0.0001||||||Hierarchical testing procedure continued only, if the previous comparison was statistically significant. Threshold for significance at 0.05 level.|ANCOVA|1st trend test||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Overall 1st trend test based on a contrast with coefficients of +3, +1, -1, -3 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide. Here it is test 1 of testing order.||||< 0.0001
91671151|NCT02973321|183237849|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.956|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.359|-0.552||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Second Trend test based on a contrast with coefficients of 0, +1, 0, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 3 of hierarchical testing sequence.||-0.552|-1.359|< 0.0001
91671152|NCT02973321|183237849|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.854|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001|TWO_SIDED|95.0|-1.264|-0.444||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Third Trend test based on a contrast with coefficients of 0, 0, +1, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 5 of hierarchical testing sequence.||-0.444|-1.264|< 0.0001
91671153|NCT02973321|183237850|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.||||||0.0012||||||Threshold for significance at 0.05 level.|ANCOVA|1st Trend test||Placebo, SAR425899 0.12,0.16,0.20 mg: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 2 of hierarchical testing sequence.||||0.0012
91671154|NCT02973321|183237850|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant|LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|0.887|<|0.0001|TWO_SIDED|95.0|-5.309|-1.832||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||SAR425899 0.16 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 4 of hierarchical testing sequence.||-1.832|-5.309|< 0.0001
91671155|NCT02973321|183237850|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-2.517|STANDARD_ERROR_OF_MEAN|0.891||0.0047|TWO_SIDED|95.0|-4.264|-0.77||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||3rd Trend Test: SAR425899 0.12 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 6 of hierarchical testing sequence.||-0.77|-4.264|0.0047
91671156|NCT01098110|183237865|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-11.29|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-15.42|-7.16||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-7.16|-15.42|<0.0001
91715335|NCT01868646|183321825|SUPERIORITY|||||||0.6155||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.6155
91671157|NCT01098110|183237865|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.22|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-17.33|-9.12||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-9.12|-17.33|<0.0001
91715336|NCT01868646|183321825|SUPERIORITY|||||||0.7507||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.7507
91671158|NCT01098110|183237866|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.47|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-4.8|-2.13|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-2.13|-4.80|<0.0001
91671159|NCT01098110|183237866|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.11|-2.46|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-2.46|-5.11|<0.0001
91671160|NCT01098110|183237867|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.47|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.53|-1.41|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.41|-3.53|<0.0001
91792785|NCT02751931|183463232|OTHER||Mean Difference (Net)|59.31||||0.002|TWO_SIDED|95.0|23.8|94.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||94.9|23.8|0.002
91792786|NCT02751931|183463232|OTHER||Mean Difference (Net)|53.87|||<|0.001|TWO_SIDED|95.0|24.5|83.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||83.2|24.5|<0.001
91671161|NCT01098110|183237867|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.08|-1.97|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.97|-4.08|<0.0001
91671162|NCT01098110|183237868|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-5.46|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-7.56|-3.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-3.35|-7.56|<0.0001
91671163|NCT01098110|183237868|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.53|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-8.62|-4.44||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-4.44|-8.62|<0.0001
91671164|NCT01098110|183237869|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.41|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.72|-2.09|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-2.09|-4.72|<0.0001
91671165|NCT01098110|183237869|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.97|-2.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.35|-4.97|<0.0001
91671166|NCT01098110|183237870|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.36|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.47|-1.26|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-1.26|-3.47|<0.0001
91671167|NCT01098110|183237870|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.03|-1.84|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-1.84|-4.03|<0.0001
91792787|NCT02751931|183463232|OTHER||Mean Difference (Net)|52.14||||0.002|TWO_SIDED|95.0|20.5|83.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||83.8|20.5|0.002
91792788|NCT02751931|183463232|OTHER||Mean Difference (Net)|42.84|||<|0.001|TWO_SIDED|95.0|22.0|63.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||63.7|22.0|<0.001
91792789|NCT02751931|183463232|OTHER||Mean Difference (Net)|42.4||||0.008|TWO_SIDED|95.0|12.5|72.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||72.3|12.5|0.008
91485328|NCT01886716|182843941|SUPERIORITY_OR_OTHER||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.07|=|0.67|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .18|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training"||||=.67
91485329|NCT01886716|182843941|SUPERIORITY_OR_OTHER||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.07|=|0.32|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = 1.01|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training"||||=.32
91485330|NCT01051466|182843943|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||The significance level was 0.05 for a 2-sided test.|Mixed Models Analysis|||||||0.457
91485331|NCT01051466|182843944|SUPERIORITY_OR_OTHER|||||||0.627||||||The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.|Mixed Models Analysis|||||||0.627
91485332|NCT01051466|182843944|SUPERIORITY_OR_OTHER|||||||0.338||||||The p-value is for change from baseline activation (BOLD response) in the left amygdala.|Mixed Models Analysis|||||||0.338
91485333|NCT01051466|182843944|SUPERIORITY_OR_OTHER|||||||0.518||||||The p-value is for change from baseline activation (BOLD response) in the right amygdala.|Mixed Models Analysis|||||||0.518
91485334|NCT01051466|182843945|SUPERIORITY_OR_OTHER|||||||0.03||||||The p-value is for change from baseline volume in the subgenual anterior cingulate.|Mixed Models Analysis|||||||0.030
91485335|NCT01051466|182843945|SUPERIORITY_OR_OTHER|||||||0.208||||||The p-value is for change from baseline volume in the left amygdalae.|Mixed Models Analysis|||||||0.208
91792790|NCT02751931|183463233|OTHER||Mean Difference (Net)|17.5||||0.126|TWO_SIDED|95.0|-5.1|40.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.1|-5.1|0.126
91671168|NCT01098110|183237871|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-3.73|-1.7|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.70|-3.73|<0.0001
91671169|NCT01098110|183237871|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.08|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.09|-2.08|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.08|-4.09|<0.0001
91671170|NCT01098110|183237872|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.62|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.41|-0.83|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.83|-2.41|<0.0001
91671171|NCT01098110|183237872|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.26|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.04|-1.47|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.47|-3.04|<0.0001
91671172|NCT01098110|183237873|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.41|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.04|-0.78|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.78|-2.04|<0.0001
91671173|NCT01098110|183237873|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.16|-0.91|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.91|-2.16|<0.0001
91671174|NCT01098110|183237874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.6||||0.0001|TWO_SIDED|95.0|9.2|28.1||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||28.1|9.2|0.0001
91485336|NCT01051466|182843945|SUPERIORITY_OR_OTHER|||||||0.031||||||The p-value is for change from baseline volume in the right amygdalae.|Mixed Models Analysis|||||||0.031
91671175|NCT01098110|183237874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||<|0.0001|TWO_SIDED|95.0|13.7|32.6||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||32.6|13.7|<0.0001
91671176|NCT01098110|183237875|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.28|-0.75|<0.0001
91671177|NCT01098110|183237875|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.82|-0.36|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.36|-0.82|<0.0001
91671178|NCT01098110|183237876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.2|||<|0.0001|TWO_SIDED|95.0|12.0|32.4||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||32.4|12.0|<0.0001
91671179|NCT01098110|183237876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.8|||<|0.0001|TWO_SIDED|95.0|18.9|38.8||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||38.8|18.9|<0.0001
91671180|NCT01028911|183237912|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|128.4|||||TWO_SIDED|90.0|75.9|217.21||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||217.21|75.90|
91671181|NCT01028911|183237913|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|119.82|||||TWO_SIDED|90.0|75.9|189.16||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||189.16|75.90|
91671182|NCT05212883|183237921|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||Comparison of the likelihood to test before gathering for age \< 18 vs. age \>= 18.||1.3|0.8|
91671183|NCT02502734|183237933|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|Mean Difference (Final Values)|-0.052|||||TWO_SIDED|95.0|-0.1217|0.0176||Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025,1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|ANCOVA|Analysis performed using ANCOVA with covariates period-level baseline and subject-level baseline lower-leg length, age, gender, treatment and period.||||0.0176|-0.1217|
91671184|NCT03476317|183237944|EQUIVALENCE|Median difference in calprotectin for controls from day 12 to baseline||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91671185|NCT00530348|183238008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.2173|TWO_SIDED|95.0|0.4|1.23||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.||1.23|0.40|0.2173
91671186|NCT00530348|183238009|SUPERIORITY_OR_OTHER||Rate ratio|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.63|0.32|<0.0001
91715337|NCT01868646|183321825|SUPERIORITY|||||||0.4195||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.4195
91671187|NCT00530348|183238010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.33|0.61|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||0.61|0.33|<0.0001
91671188|NCT00530348|183238011|SUPERIORITY_OR_OTHER|||||||0.4188|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.4188
91671189|NCT00530348|183238012|SUPERIORITY_OR_OTHER|||||||0.0115|||||||Wei-Lachin|||Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.||||0.0115
91671190|NCT00530348|183238013|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.3080
91671191|NCT04364763|183238014|SUPERIORITY|||||||0.0352||||||p-value is for Day 7|Mixed Models Analysis|||||||0.0352
91671192|NCT04364763|183238014|SUPERIORITY|||||||0.235||||||p-value is for Day 28|Mixed Models Analysis|||Comparison made for Day 7 and Day 28||||0.2350
91671193|NCT00127166|183238103|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.25||||0.009||95.0|-5.66|-0.84|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period||||-0.84|-5.66|0.009
91671194|NCT00127166|183238104|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-52.71||||0.006||95.0|-89.76|-15.66|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||-15.66|-89.76|0.006
91671195|NCT00127166|183238105|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.11|||<|0.001||95.0|2.58|5.64|||ANCOVA|Participant, treatment, period \& covariate for FEV1 %-predicted Treatment test is adjusted for period \& FEV1 %-predicted at pre-exercise baseline||||5.64|2.58|<0.001
91671196|NCT00127166|183238106|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.26||||0.035||95.0|1.02|1.55|||Cox Proportional Hazards Model|Model terms: treatment and period|Dispersion not applicable to time to event data|||1.55|1.02|0.035
91671197|NCT00127166|183238107|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.8|||<|0.001||95.0|2.28|5.32|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||5.32|2.28|<0.001
91671198|NCT01396421|183238108|SUPERIORITY_OR_OTHER||Treatment difference|-8.18|||<|0.0001|TWO_SIDED|95.0|-12.0|-4.4||Primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) which included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed.||-4.40|-12.0|<0.0001
91671199|NCT01396421|183238108|SUPERIORITY_OR_OTHER||Treatment difference|-7.64||||0.0006|TWO_SIDED|95.0|-12.0|-3.3|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-3.30|-12.0|0.0006
91671200|NCT01396421|183238108|SUPERIORITY_OR_OTHER||Traetment difference|-8.72|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.37|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-4.37|-13.1|<0.0001
91671201|NCT01396421|183238108|SUPERIORITY_OR_OTHER||Treatment difference|-2.89||||0.291|TWO_SIDED|95.0|-8.27|2.49|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||2.49|-8.27|0.2910
91671202|NCT01396421|183238109|SUPERIORITY_OR_OTHER||Treatment difference|-0.36||||0.0006|TWO_SIDED|95.0|-0.56|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between the average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed at a significance level of 0.05.||-0.15|-0.56|0.0006
91671203|NCT01396421|183238109|SUPERIORITY_OR_OTHER||Treatment difference|-0.38||||0.0012|TWO_SIDED|95.0|-0.61|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.15|-0.61|0.0012
91671204|NCT01396421|183238109|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.10|-0.56|0.0056
91671205|NCT01396421|183238109|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.8491|TWO_SIDED|95.0|-0.31|0.26|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||0.26|-0.31|0.8491
91671206|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-1.5||||0.0644|TWO_SIDED|95.0|-3.09|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, and baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.09|-3.09|0.0644
91671207|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-1.99||||0.0139|TWO_SIDED|95.0|-3.58|-0.41||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||-0.41|-3.58|0.0139
91671208|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|0.35||||0.7231|TWO_SIDED|95.0|-1.61|2.32||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||2.32|-1.61|0.7231
91671209|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-5.14||||0.0018|TWO_SIDED|95.0|-8.36|-1.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-1.93|-8.36|0.0018
91792791|NCT02751931|183463233|OTHER||Mean Difference (Net)|42.38||||0.014|TWO_SIDED|95.0|9.3|75.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||75.4|9.3|0.014
91792792|NCT02751931|183463233|OTHER||Mean Difference (Net)|46.69|||<|0.001|TWO_SIDED|95.0|21.7|71.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||71.7|21.7|<0.001
91485337|NCT01051466|182843945|SUPERIORITY_OR_OTHER|||||||0.35||||||The p-value is for change from baseline volume in the left hippocampus.|Mixed Models Analysis|||||||0.350
91485338|NCT01051466|182843945|SUPERIORITY_OR_OTHER|||||||0.191||||||The p-value is for change from baseline volume in the right hippocampus.|Mixed Models Analysis|||||||0.191
91485339|NCT01051466|182843946|SUPERIORITY_OR_OTHER|||||||0.174||||||The p-value is for Gsα translocation in RBCs at Week 1.|Mixed Models Analysis|||||||0.174
91671210|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-3.75||||0.0045|TWO_SIDED|95.0|-6.33|-1.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 2||||-1.17|-6.33|0.0045
91671211|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|1.84||||0.2568|TWO_SIDED|95.0|-1.34|5.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||5.02|-1.34|0.2568
91485340|NCT01051466|182843946|SUPERIORITY_OR_OTHER|||||||0.488||||||The p-value is for Gsα translocation in RBCs at Week 8.|Mixed Models Analysis|||||||0.488
91671212|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-4.4||||0.0009|TWO_SIDED|95.0|-6.97|-1.82||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-1.82|-6.97|0.0009
91671213|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-3.45||||0.036|TWO_SIDED|95.0|-6.67|-0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.23|-6.67|0.0360
91671214|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9876|TWO_SIDED|95.0|-4.53|4.6||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||4.60|-4.53|0.9876
91671215|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-7.61|||<|0.0001|TWO_SIDED|95.0|-11.3|-3.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-3.93|-11.3|<0.0001
91671216|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-5.16||||0.0062|TWO_SIDED|95.0|-8.85|-1.47||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 4||||-1.47|-8.85|0.0062
91671217|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|1.93||||0.3407|TWO_SIDED|95.0|-2.05|5.9||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||5.90|-2.05|0.3407
91671218|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-7.86||||0.0001|TWO_SIDED|95.0|-11.9|-3.86||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 5||||-3.86|-11.9|0.0001
91671219|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-7.15||||0.0005|TWO_SIDED|95.0|-11.2|-3.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-3.14|-11.2|0.0005
91671220|NCT01396421|183238110|SUPERIORITY_OR_OTHER||Treatment difference|-1.12||||0.657|TWO_SIDED|95.0|-6.07|3.83||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.|||3.83|-6.07|0.6570
91792793|NCT02751931|183463233|OTHER||Mean Difference (Net)|73.25||||0.002|TWO_SIDED|95.0|29.3|117.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||117.2|29.3|0.002
91637254|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-6.97|6.64|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.64|-6.97|
91637255|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-7.74|STANDARD_ERROR_OF_MEAN|3.51|||TWO_SIDED|95.0|-15.03|-0.44|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-0.44|-15.03|
91637256|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-10.88|3.16|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.16|-10.88|
91637257|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-9.53|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-16.1|-2.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8||-2.95|-16.10|
91792794|NCT02751931|183463233|OTHER|Pre-Specified|Mean Difference (Net)|45.27|||<|0.001|TWO_SIDED|95.0|22.1|68.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||68.4|22.1|<0.001
91485341|NCT01051466|182843946|SUPERIORITY_OR_OTHER|||||||0.48||||||The p-value is for Gsα translocation in RBCs at Week 12.|Mixed Models Analysis|||||||0.480
91485342|NCT01051466|182843946|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for Gsα translocation in platelets at Week 1.|Mixed Models Analysis|||||||0.925
91485343|NCT01051466|182843946|SUPERIORITY_OR_OTHER|||||||0.697||||||The p-value is for Gsα translocation in platelets at Week 8.|Mixed Models Analysis|||||||0.697
91485344|NCT01051466|182843946|SUPERIORITY_OR_OTHER|||||||0.276||||||The p-value is for Gsα translocation in platelets at Week 12.|Mixed Models Analysis|||||||0.276
91485345|NCT01051466|182843948|SUPERIORITY_OR_OTHER|||||||0.904||||||The p-value is for change from baseline BDNF.|Mixed Models Analysis|||||||0.904
91485346|NCT01051466|182843948|SUPERIORITY_OR_OTHER|||||||0.819||||||The p-value is for change from baseline proBDNF.|Mixed Models Analysis|||||||0.819
91485347|NCT01051466|182843949|SUPERIORITY_OR_OTHER|||||||0.273||||||The p-value is for change from baseline trkB.|Mixed Models Analysis|||||||0.273
91485348|NCT01051466|182843950|SUPERIORITY_OR_OTHER|||||||0.797||||||The p-value is for change from baseline cytokine TNFα.|Mixed Models Analysis|||||||0.797
91637258|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-5.66|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-11.82|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||0.50|-11.82|
91637259|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-8.62|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-17.77|0.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||0.54|-17.77|
91485349|NCT01051466|182843950|SUPERIORITY_OR_OTHER|||||||0.269||||||The p-value is for change from baseline cytokine IL-1.|Mixed Models Analysis|||||||0.269
91485350|NCT01051466|182843950|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for change from baseline cytokine IL-6.|Mixed Models Analysis|||||||0.925
91485351|NCT04806503|182843962|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.006|STANDARD_ERROR_OF_MEAN|0.0258||0.817|TWO_SIDED|95.0|-0.045|0.056|||Mixed-effect Model for Repeated Measures|||||0.056|-0.045|0.817
91485352|NCT04806503|182843962|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.002|STANDARD_ERROR_OF_MEAN|0.0262||0.946|TWO_SIDED|95.0|-0.05|0.053|||Mixed-effect Model for Repeated Measures|||||0.053|-0.050|0.946
91485353|NCT04806503|182843962|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|-0.024|STANDARD_ERROR_OF_MEAN|0.027||0.38|TWO_SIDED|95.0|-0.077|0.029|||Mixed-effect Model for Repeated Measures|||||0.029|-0.077|0.380
91485354|NCT04806503|182843962|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.011|STANDARD_ERROR_OF_MEAN|0.0258||0.667|TWO_SIDED|95.0|-0.039|0.062|||Mixed-effect Model for Repeated Measures|||||0.062|-0.039|0.667
91485355|NCT04806503|182843963|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.022|STANDARD_ERROR_OF_MEAN|0.0304||0.474|TWO_SIDED|95.0|-0.038|0.081|||Mixed-effect Model for Repeated Measures|||||0.081|-0.038|0.474
91485356|NCT04806503|182843963|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.025|STANDARD_ERROR_OF_MEAN|0.0309||0.419|TWO_SIDED|95.0|-0.036|0.086|||Mixed-effect Model for Repeated Measures|||||0.086|-0.036|0.419
91485357|NCT04806503|182843963|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.003|STANDARD_ERROR_OF_MEAN|0.0322||0.914||95.0|-0.06|0.067|||Mixed-effect Model for Repeated Measures|||||0.067|-0.060|0.914
91485358|NCT04806503|182843963|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.034|STANDARD_ERROR_OF_MEAN|0.0305||0.263|TWO_SIDED|95.0|-0.026|0.094|||Mixed-effect Model for Repeated Measures|||||0.094|-0.026|0.263
91485359|NCT04806503|182843964|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.029|STANDARD_ERROR_OF_MEAN|0.0273||0.284|TWO_SIDED|95.0|-0.024|0.083|||Mixed-effect Model for Repeated Measures|||||0.083|-0.024|0.284
91485360|NCT04806503|182843964|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0278||0.711|TWO_SIDED|95.0|-0.044|0.065|||Mixed-effect Model for Repeated Measures|||||0.065|-0.044|0.711
91485361|NCT04806503|182843964|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.005|STANDARD_ERROR_OF_MEAN|0.0284||0.871|TWO_SIDED|95.0|-0.051|0.06|||Mixed-effect Model for Repeated Measures|||||0.060|-0.051|0.871
91485362|NCT04806503|182843964|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0273||0.329|TWO_SIDED|95.0|-0.027|0.08|||Mixed-effect Model for Repeated Measures|||||0.080|-0.027|0.329
91792795|NCT02751931|183463233|OTHER||Mean Difference (Net)|42.86||||0.02|TWO_SIDED|95.0|7.4|78.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.3|7.4|0.020
91792796|NCT02751931|183463233|OTHER||Mean Difference (Net)|33.23||||0.003|TWO_SIDED|95.0|12.2|54.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||54.3|12.2|0.003
91526330|NCT03469349|182927843|SUPERIORITY|||||||0.0023|||||||MMRM|||Week 24: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0023
91526331|NCT03469349|182927844|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9592||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 12||||0.9592
91526332|NCT03469349|182927844|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.5823||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 24||||0.5823
91526333|NCT03469349|182927845|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9424||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||||||0.9424
91526334|NCT03469349|182927846|SUPERIORITY|||||||0.3758|||||||MMRM|||Physical Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.3758
91526335|NCT03469349|182927846|SUPERIORITY|||||||0.1412|||||||MMRM|||Physical Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1412
91526336|NCT03469349|182927846|SUPERIORITY|||||||0.1009|||||||MMRM|||Mental Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1009
91526337|NCT03469349|182927846|SUPERIORITY|||||||0.0015|||||||MMRM|||Mental Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0015
91526338|NCT00868699|182927854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
91526339|NCT00868699|182927854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
91526340|NCT00868699|182927855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
91526341|NCT00868699|182927855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
91526342|NCT00868699|182927856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.003|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||0.003
91526343|NCT00868699|182927856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
91526344|NCT02307513|182927880|SUPERIORITY||Difference in LS Mean|-92.6|||<|0.0001|TWO_SIDED|95.0|-130.59|-54.6|||ANCOVA|ANCOVA model with AUC W0-12 as the response variables; treatment arm, sex, region as factors and the number of oral ulcers at baseline as a covariate.|Treatment difference = Apremilast - Placebo|The AUC W0-12 for oral ulcer counts was compared between the placebo treatment group and the apremilast 30 BID treatment group using a 2-tailed parametric analysis of covariance (ANCOVA) test at the 0.05 significance level.||-54.60|-130.59|<0.0001
91792797|NCT02751931|183463233|OTHER||Mean Difference (Net)|47.29||||0.003|TWO_SIDED|95.0|17.8|76.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||76.8|17.8|0.003
91526345|NCT02307513|182927881|SUPERIORITY||Difference in LS Mean|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.8|-16.8|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-16.8|-32.8|<0.0001
91526346|NCT02307513|182927882|SUPERIORITY||Difference in LS Mean|-11.94|||<|0.0001|TWO_SIDED|95.0|-16.2|-7.67|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-7.67|-16.20|<0.0001
91526347|NCT02307513|182927883|SUPERIORITY||Difference in LS Means|-0.5||||0.0335|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.0|-1.0|0.0335
91526348|NCT02307513|182927884|SUPERIORITY||Difference in LS Means|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.6|-1.4|<0.0001
91792798|NCT02751931|183463233|OTHER||Mean Difference (Net)|49.88||||0.004|TWO_SIDED|95.0|17.1|82.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||82.6|17.1|0.004
91671221|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.6553|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6553
91671222|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.617|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6170
91671223|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|0.03||||0.6446|TWO_SIDED|95.0|-0.1|0.15||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates..|Mixed Models Analysis|Week 1||||0.15|-0.10|0.6446
91526349|NCT02307513|182927885|SUPERIORITY||Difference in LS Means|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.5|-1.3|<0.0001
91671224|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.0347|TWO_SIDED|95.0|-0.29|-0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-0.01|-0.29|0.0347
91671225|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Leasr squares mean|-0.12||||0.0825|TWO_SIDED|95.0|-0.27|0.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.02|-0.27|0.0825
91671226|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|0.12||||0.1678|TWO_SIDED|95.0|-0.05|0.3||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||0.30|-0.05|0.1678
91671227|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.0219|TWO_SIDED|95.0|-0.39|-0.03||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.03|-0.39|0.0219
91671228|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Least squares mean|-0.09||||0.3275|TWO_SIDED|95.0|-0.27|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.09|-0.27|0.3275
91671229|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.1173|TWO_SIDED|95.0|-0.04|0.4||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.40|-0.04|0.1173
91671230|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.21||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-0.21|-0.63|<0.0001
91792799|NCT02751931|183463233|OTHER||Mean Difference (Net)|84.39||||0.003|TWO_SIDED|95.0|31.6|137.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||137.1|31.6|0.003
91792800|NCT02751931|183463233|OTHER||Mean Difference (Net)|60.09||||0.003|TWO_SIDED|95.0|21.2|99.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||99.0|21.2|0.003
91671231|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Least squares mean|-0.19||||0.0662|TWO_SIDED|95.0|-0.4|0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.01|-0.40|0.0662
91671232|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7587|TWO_SIDED|95.0|-0.3|0.22||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.22|-0.30|0.7587
91671233|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.39||||0.0006|TWO_SIDED|95.0|-0.61|-0.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.17|-0.61|0.0006
91671234|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Least squares mean|-0.34||||0.0032|TWO_SIDED|95.0|-0.56|-0.11||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.11|-0.56|0.0032
91671235|NCT01396421|183238111|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7619|TWO_SIDED|95.0|-0.32|0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||0.23|-0.32|0.7619
91671236|NCT01396421|183238112|SUPERIORITY_OR_OTHER||Treatment difference|2.46||||0.0557|TWO_SIDED|95.0|-0.06|4.98||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.98|-0.06|0.0557
91671237|NCT01396421|183238112|SUPERIORITY_OR_OTHER||Treatment difference|2.89||||0.025|TWO_SIDED|95.0|0.37|5.42||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||5.42|0.37|0.0250
91671238|NCT01396421|183238112|SUPERIORITY_OR_OTHER||Treatment difference|1.58||||0.3264|TWO_SIDED|95.0|-1.58|4.74||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.74|-1.58|0.3264
91671239|NCT01396421|183238113|SUPERIORITY_OR_OTHER||Treatment difference|-2.44||||0.001|TWO_SIDED|95.0|-3.88|-0.99||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.99|-3.88|0.0010
91671240|NCT01396421|183238113|SUPERIORITY_OR_OTHER||Treatment difference|-2.22||||0.0029|TWO_SIDED|95.0|-3.67|-0.77||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.77|-3.67|0.0029
91671241|NCT01396421|183238113|SUPERIORITY_OR_OTHER||Treatment difference|-1.11||||0.2227|TWO_SIDED|95.0|-2.9|0.68||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.68|-2.90|0.2227
91671242|NCT01396421|183238114|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.0069|TWO_SIDED|95.0|-2.44|0.39||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.39|-2.44|0.0069
91671243|NCT01396421|183238114|SUPERIORITY_OR_OTHER||Least squares mean|-1.78||||0.0007|TWO_SIDED|95.0|-2.81|-0.76||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.76|-2.81|0.0007
91671244|NCT01396421|183238114|SUPERIORITY_OR_OTHER||Treatmetn difference|-1.07||||0.0996|TWO_SIDED|95.0|-2.33|0.2||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.20|-2.33|0.0996
91671245|NCT01396421|183238115|SUPERIORITY_OR_OTHER||Treatment difference|-0.5||||0.0004|TWO_SIDED|95.0|-0.77|-0.22||The Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.22|-0.77|0.0004
91671246|NCT01396421|183238115|SUPERIORITY_OR_OTHER||Treatment difference|-0.54||||0.0002|TWO_SIDED|95.0|-0.82|-0.26||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.26|-0.82|0.0002
91671247|NCT01396421|183238115|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.4505|TWO_SIDED|95.0|-0.5|0.22||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||0.22|-0.50|0.4505
91671248|NCT01396421|183238116|SUPERIORITY_OR_OTHER||Relative risk|1.48||||0.0032|TWO_SIDED|95.0|1.14|1.91||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.91|1.14|0.0032
91671249|NCT01396421|183238116|SUPERIORITY_OR_OTHER||Relative risk|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.05||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||2.05|1.23|0.0004
91671250|NCT01396421|183238116|SUPERIORITY_OR_OTHER||Relative risk|1.27||||0.1576|TWO_SIDED|95.0|0.92|1.76||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.76|0.92|0.1576
91671251|NCT01396421|183238117|SUPERIORITY_OR_OTHER||Treatment difference|-1.1||||0.0246|TWO_SIDED|95.0|-2.06|-0.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.14|-2.06|0.0246
91671252|NCT01396421|183238117|SUPERIORITY_OR_OTHER||Treatment difference|-1.22||||0.0131|TWO_SIDED|95.0|-2.19|-0.26||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.26|-2.19|0.0131
91671253|NCT01396421|183238117|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.5706|TWO_SIDED|95.0|-1.53|0.85||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.85|-1.53|0.5706
91671254|NCT01396421|183238118|SUPERIORITY_OR_OTHER||Relative risk|0.39||||0.0143|TWO_SIDED|95.0|0.18|0.85|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.||||0.85|0.18|0.0143
91671255|NCT01396421|183238118|SUPERIORITY_OR_OTHER||Relative risk|0.87||||0.6606|TWO_SIDED|95.0|0.46|1.65||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.65|0.46|0.6606
91526350|NCT02307513|182927886|SUPERIORITY||Adjusted difference in percentages|25.1|||<|0.0001|TWO_SIDED|95.0|15.5|34.6|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||34.6|15.5|<0.0001
91526351|NCT02307513|182927887|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.0001|TWO_SIDED|95.0|1.692|3.405|||Stratified Log-Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors.|||3.405|1.692|<0.0001
91671256|NCT01396421|183238118|SUPERIORITY_OR_OTHER||Relative risk|0.77||||0.5115|TWO_SIDED|95.0|0.35|1.68||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.68|0.35|0.5115
91671257|NCT01396421|183238119|SUPERIORITY_OR_OTHER||Treatment difference|-2.34||||0.0014|TWO_SIDED|95.0|-3.77|-0.91||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.91|-3.77|0.0014
91671258|NCT01396421|183238119|SUPERIORITY_OR_OTHER||Treatment difference|-2.47||||0.0008|TWO_SIDED|95.0|-3.91|-1.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-1.04|-3.91|0.0008
91671259|NCT01396421|183238119|SUPERIORITY_OR_OTHER||Treatment difference|-0.89||||0.3263|TWO_SIDED|95.0|-2.66|0.89||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|||||0.89|-2.66|0.3263
91671260|NCT01396421|183238120|SUPERIORITY_OR_OTHER||Treatment difference|-1.3||||0.0155|TWO_SIDED|95.0|-2.35|-0.25||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.25|-2.35|0.0155
91671261|NCT01396421|183238120|SUPERIORITY_OR_OTHER||Treatment difference|-1.68||||0.0019|TWO_SIDED|95.0|-2.73|-0.62||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.62|-2.73|0.0019
91671262|NCT01396421|183238120|SUPERIORITY_OR_OTHER||Treatment difference|-0.86||||0.1956|TWO_SIDED|95.0|-2.17|0.44||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.44|-2.17|0.1956
91671263|NCT01396421|183238121|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.75|-2.76|0.0007
91671264|NCT01396421|183238121|SUPERIORITY_OR_OTHER||Treatment difference|-1.98||||0.0001|TWO_SIDED|95.0|-2.98|-0.97||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.97|-2.98|0.0001
91671265|NCT01396421|183238121|SUPERIORITY_OR_OTHER||Treatment difference|-0.72||||0.2572|TWO_SIDED|95.0|-1.96|0.52||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.52|-1.96|0.2572
91671266|NCT01396421|183238122|SUPERIORITY_OR_OTHER||Treatment difference|-1.07||||0.0085|TWO_SIDED|95.0|-1.87|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.87|0.0085
91671267|NCT01396421|183238122|SUPERIORITY_OR_OTHER||Treatment difference|-1.08||||0.0081|TWO_SIDED|95.0|-1.88|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.88|0.0081
91671268|NCT01396421|183238122|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.5172|TWO_SIDED|95.0|-1.31|0.66||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.66|-1.31|0.5172
91671269|NCT01396421|183238123|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.3284|TWO_SIDED|95.0|-1.03|0.35||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.35|-1.03|0.3284
91671270|NCT01396421|183238123|SUPERIORITY_OR_OTHER||Treatment difference|-0.65||||0.0655|TWO_SIDED|95.0|-1.34|0.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.04|-1.34|0.0655
91671271|NCT01396421|183238123|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.6251|TWO_SIDED|95.0|-1.07|0.64||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.64|-1.07|0.6251
91671272|NCT01610063|183238130|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison for QIDS-C16||||<0.0001
91715338|NCT01868646|183321825|SUPERIORITY|||||||0.3609||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.3609
91715339|NCT01868646|183321826|SUPERIORITY|||||||0.0605|||||||t-test, 2 sided|||||||0.0605
91485363|NCT04806503|182843965|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.95||||0.516|TWO_SIDED|95.0|0.083|10.847|||Multiple Imputation, Logistic Regression|||||10.847|0.083|0.516
91485364|NCT04806503|182843965|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|2.45||||0.177|TWO_SIDED|95.0|0.367|16.398|||Multiple Imputation, Logistic Regression|||||16.398|0.367|0.177
91485365|NCT04806503|182843965|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|3.65||||0.079|TWO_SIDED|95.0|0.604|22.094|||Multiple Imputation, Logistic Regression|||||22.094|0.604|0.079
91671273|NCT01610063|183238131|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups for HAMD-17||||<0.0001
91671274|NCT01610063|183238132|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison for PHQ-9||||0.002
91671275|NCT00442546|183238138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.691|-0.766|0.9185
91671276|NCT00442546|183238138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.392|-1.070|0.3619
91671277|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.065|STANDARD_ERROR_OF_MEAN|19.426||0.4091||95.0|-54.332|22.203|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.203|-54.332|0.4091
91671278|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.548|STANDARD_ERROR_OF_MEAN|19.388||0.4234||95.0|-53.74|22.645|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.645|-53.740|0.4234
91671279|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.428|STANDARD_ERROR_OF_MEAN|16.517||0.0284||95.0|-68.972|-3.884|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||-3.884|-68.972|0.0284
91671280|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-28.985|STANDARD_ERROR_OF_MEAN|16.57||0.0816||95.0|-61.632|3.663|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||3.663|-61.632|0.0816
91715340|NCT01868646|183321827|SUPERIORITY|||||||0.0726|||||||t-test, 2 sided|||||||0.0726
91715341|NCT01868646|183321828|SUPERIORITY|||||||0.3108|||||||Fisher Exact|||||||0.3108
91715342|NCT01868646|183321829|SUPERIORITY|||||||0.2934|||||||t-test, 2 sided|||||||0.2934
91715343|NCT01868646|183321830|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||||||0.3410
91715344|NCT01868646|183321831|SUPERIORITY|||||||0.1577|||||||t-test, 2 sided|||Satisfaction||||0.1577
91715345|NCT01868646|183321831|SUPERIORITY|||||||0.5262|||||||t-test, 2 sided|||Hyperglycemia||||0.5262
91715346|NCT01868646|183321831|SUPERIORITY|||||||0.7417|||||||t-test, 2 sided|||Hypoglycemia||||0.7417
91671281|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.759|STANDARD_ERROR_OF_MEAN|11.752||0.8147||95.0|-20.446|25.964|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||25.964|-20.446|0.8147
91671282|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.182|STANDARD_ERROR_OF_MEAN|11.589||0.7187||95.0|-27.064|18.7|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||18.700|-27.064|0.7187
91671283|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.356|STANDARD_ERROR_OF_MEAN|10.148||0.7416||95.0|-23.516|16.804|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||16.804|-23.516|0.7416
91671284|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.574|STANDARD_ERROR_OF_MEAN|9.283||0.2577||95.0|-29.017|7.869|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||7.869|-29.017|0.2577
91671285|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|17.387||0.9982||95.0|-36.431|36.352|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||36.352|-36.431|0.9982
91671286|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.325|STANDARD_ERROR_OF_MEAN|22.184||0.5552||95.0|-59.756|33.107|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||33.107|-59.756|0.5552
91671287|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|STANDARD_ERROR_OF_MEAN|24.655||0.2032||95.0|-118.463|38.463|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||38.463|-118.463|0.2032
91671288|NCT00442546|183238139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-138.5|STANDARD_ERROR_OF_MEAN|37.661||0.0348||95.0|-258.354|-18.646|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||-18.646|-258.354|0.0348
91671289|NCT00442546|183238140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.136|STANDARD_ERROR_OF_MEAN|4.499||0.3602||95.0|-4.79|13.062|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||13.062|-4.790|0.3602
91671290|NCT00442546|183238140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.573|STANDARD_ERROR_OF_MEAN|4.637||0.7352||95.0|-7.626|10.771|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||10.771|-7.626|0.7352
91671291|NCT00442546|183238140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|6.156||0.6435||95.0|-9.392|15.111|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.111|-9.392|0.6435
91671292|NCT00442546|183238140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.237|STANDARD_ERROR_OF_MEAN|6.361||0.6123||95.0|-9.422|15.895|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.895|-9.422|0.6123
91671293|NCT00442546|183238140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|7.663||0.6356||95.0|-11.683|18.984|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||18.984|-11.683|0.6356
91671294|NCT00442546|183238140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|7.747||0.907||95.0|-14.593|16.411|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||16.411|-14.593|0.9070
91671295|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1190.65|STANDARD_ERROR_OF_MEAN|123.062||0.0656||95.0|-2754.304|373.004|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||373.004|-2754.304|0.0656
91671296|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|142.1||0.9277||95.0|-1789.352|1821.752|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||1821.752|-1789.352|0.9277
91671297|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|62.692||0.935||95.0|-263.972|275.515|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||275.515|-263.972|0.9350
91671298|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.243|STANDARD_ERROR_OF_MEAN|44.33||0.6139||95.0|-164.494|216.98|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||216.980|-164.494|0.6139
91671299|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|9.96||0.776||95.0|-25.451|19.611|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||19.611|-25.451|0.7760
91671300|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|6.833||0.819||95.0|-17.066|13.846|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||13.846|-17.066|0.8190
91671301|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.235|STANDARD_ERROR_OF_MEAN|390.483||0.8603||95.0|-861.171|722.7|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||722.700|-861.171|0.8603
91671302|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.395|STANDARD_ERROR_OF_MEAN|384.376||0.9642||95.0|-796.945|762.155|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||762.155|-796.945|0.9642
91671303|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|93.693|STANDARD_ERROR_OF_MEAN|484.957||0.8476||95.0|-880.865|1068.251|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1068.251|-880.865|0.8476
91671304|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.543|STANDARD_ERROR_OF_MEAN|457.374||0.8185||95.0|-813.584|1024.67|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1024.670|-813.584|0.8185
91671305|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-682.304|STANDARD_ERROR_OF_MEAN|495.241||0.1792||95.0|-1696.759|332.15|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||332.150|-1696.759|0.1792
91671306|NCT00442546|183238141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-250.439|STANDARD_ERROR_OF_MEAN|501.808||0.6216||95.0|-1278.347|777.469|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||777.469|-1278.347|0.6216
91671307|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-494.0|STANDARD_ERROR_OF_MEAN|301.253||0.1996||95.0|-1452.72|464.72|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||464.720|-1452.720|0.1996
91671308|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-195.15|STANDARD_ERROR_OF_MEAN|368.958||0.6335||95.0|-1369.338|979.038|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||979.038|-1369.338|0.6335
91671309|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.291|STANDARD_ERROR_OF_MEAN|302.355||0.929||95.0|-657.992|603.41|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||603.410|-657.992|0.9290
91671310|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.787|STANDARD_ERROR_OF_MEAN|256.969||0.8937||95.0|-501.241|570.815|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||570.815|-501.241|0.8937
91671311|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|198.937|STANDARD_ERROR_OF_MEAN|491.153||0.6912||95.0|-847.93|1245.804|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||1245.804|-847.930|0.6912
91671312|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|185.728|STANDARD_ERROR_OF_MEAN|349.047||0.6024||95.0|-558.248|929.704|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||929.704|-558.248|0.6024
91671313|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-256.921|STANDARD_ERROR_OF_MEAN|407.391||0.5372||95.0|-1120.551|606.709|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||606.709|-1120.551|0.5372
91671314|NCT00442546|183238142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-287.032|STANDARD_ERROR_OF_MEAN|328.227||0.3948||95.0|-982.843|408.778|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||408.778|-982.843|0.3948
91671315|NCT00442546|183238143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-121.5|STANDARD_ERROR_OF_MEAN|1169.654||0.9341|TWO_SIDED|95.0|-14983.36|14740.362|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||14740.362|-14983.36|0.9341
91671316|NCT00442546|183238145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|302.9|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|302.9|302.9|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||302.900|302.900|<0.0001
91671317|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.087||0.1661||95.0|-0.293|0.051|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.051|-0.293|0.1661
91671318|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.088||0.3604||95.0|-0.254|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.093|-0.254|0.3604
91671319|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.083||0.1299||95.0|-0.29|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.037|-0.290|0.1299
91671320|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.129|STANDARD_ERROR_OF_MEAN|0.082||0.1167||95.0|-0.29|0.032|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.032|-0.290|0.1167
91671321|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.09||0.5271||95.0|-0.234|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.234|0.5271
91671322|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.09||0.6731||95.0|-0.215|0.139|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.139|-0.215|0.6731
91671323|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.098||0.5936||95.0|-0.247|0.142|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.142|-0.247|0.5936
91792801|NCT02751931|183463233|OTHER||Mean Difference (Net)|54.78||||0.017|TWO_SIDED|95.0|10.6|98.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||98.9|10.6|0.017
91671324|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.094||0.8368||95.0|-0.206|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.167|-0.206|0.8368
91792802|NCT02751931|183463233|OTHER||Mean Difference (Net)|53.51||||0.001|TWO_SIDED|95.0|22.6|84.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||84.4|22.6|0.001
91671325|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.111||0.8659||95.0|-0.242|0.204|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.204|-0.242|0.8659
91671326|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.112||0.7151||95.0|-0.266|0.184|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.184|-0.266|0.7151
91671327|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.077||0.2121||95.0|-0.249|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.056|-0.249|0.2121
91485366|NCT04806503|182843965|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.07||||0.476|TWO_SIDED|95.0|0.136|8.381|||Multiple Imputation, Logistic Regression|||||8.381|0.136|0.476
91671328|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.077||0.5607||95.0|-0.197|0.107|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.107|-0.197|0.5607
91671329|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.077||0.7797||95.0|-0.13|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.173|-0.130|0.7797
91671330|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.079||0.8761||95.0|-0.143|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.167|-0.143|0.8761
91671331|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.067||0.8619||95.0|-0.121|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.144|-0.121|0.8619
91671332|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.068||0.7256||95.0|-0.111|0.159|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.159|-0.111|0.7256
91485367|NCT04806503|182843966|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.87||||0.577|TWO_SIDED|95.0|0.201|3.726|||Multiple Imputation, Logistic Regression|||||3.726|0.201|0.577
91485368|NCT04806503|182843966|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.52||||0.804|TWO_SIDED|95.0|0.113|2.353|||Multiple Imputation, Logistic Regression|||||2.353|0.113|0.804
91485369|NCT04806503|182843966|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.34||||0.85|TWO_SIDED|95.0|0.045|2.602|||Multiple Imputation, Logistic Regression|||||2.602|0.045|0.850
91485370|NCT04806503|182843966|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.69||||0.684|TWO_SIDED|95.0|0.157|3.08|||Multiple Imputation, Logistic Regression|||||3.080|0.157|0.684
91485371|NCT04806503|182843967|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.56||||0.728|TWO_SIDED|95.0|0.089|3.593|||Multiple Imputation, Logistic Regression|||||3.593|0.089|0.728
91485372|NCT04806503|182843967|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.16||||0.428|TWO_SIDED|95.0|0.242|5.529|||Multiple Imputation, Logistic Regression|||||5.529|0.242|0.428
91485373|NCT04806503|182843967|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|95.0|0.0||NA when n = 1.||Multiple Imputation, Logistic Regression||||||0.000|0.500
91485374|NCT04806503|182843967|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.28||||0.851|TWO_SIDED|95.0|0.026|3.07|||Multiple Imputation, Logistic Regression|||||3.070|0.026|0.851
91485375|NCT03793556|182844000|OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|9.27||0.276|TWO_SIDED|95.0|-7.03|2.04|||Unpaired t test|||||2.04|-7.03|0.276
91485376|NCT03793556|182844001|OTHER|||||||0.0157|||||||ANOVA|The ANOVA model examined the entire curve profile.||||||0.0157
91485377|NCT03793556|182844011|OTHER|||||||0.0496|||||||Chi-squared|||||||0.0496
91485378|NCT03793556|182844013|OTHER|||||||0.0065|||||||ANOVA|||||||0.0065
91671333|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8659||95.0|-0.11|0.131|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.131|-0.110|0.8659
91671334|NCT00442546|183238149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.063||0.0203||95.0|0.023|0.27|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.270|0.023|0.0203
91671335|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5791||95.0|-0.187|0.105|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.105|-0.187|0.5791
91671336|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.075||0.6829||95.0|-0.178|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.117|-0.178|0.6829
91671337|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.07||0.4516||95.0|-0.19|0.085|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.085|-0.190|0.4516
91671338|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.071|STANDARD_ERROR_OF_MEAN|0.069||0.3014||95.0|-0.207|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.064|-0.207|0.3014
91671339|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.075||0.7628||95.0|-0.171|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.125|-0.171|0.7628
91671340|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.075||0.711||95.0|-0.176|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.176|0.7110
91671341|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.079||0.7382||95.0|-0.183|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.130|-0.183|0.7382
91671342|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.076||0.6586||95.0|-0.183|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.116|-0.183|0.6586
91671343|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.084||0.7691||95.0|-0.195|0.145|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.145|-0.195|0.7691
91671344|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.085||0.507||95.0|-0.229|0.115|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.115|-0.229|0.5070
91671345|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.066||0.5802||95.0|-0.166|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.093|-0.166|0.5802
91671346|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.065||0.919||95.0|-0.122|0.136|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.136|-0.122|0.9190
91671347|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.059||0.6559||95.0|-0.09|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.143|-0.090|0.6559
91671348|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.06||0.8552||95.0|-0.108|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.130|-0.108|0.8552
91671349|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.048||0.6364||95.0|-0.072|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.117|-0.072|0.6364
91671350|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.049||0.2127||95.0|-0.035|0.157|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.157|-0.035|0.2127
91671351|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.047||0.8746||95.0|-0.086|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.101|-0.086|0.8746
91671352|NCT00442546|183238150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.048||0.0286||95.0|0.011|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.202|0.011|0.0286
91485379|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.375
91485380|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.156
91671353|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165|STANDARD_ERROR_OF_MEAN|0.102||0.1078||95.0|-0.367|0.036|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.036|-0.367|0.1078
91485381|NCT01325623|182844027|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||>0.999
91485382|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.906
91485383|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
91485384|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.906
91485385|NCT01325623|182844027|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||<0.001
91485386|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.106
91485387|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.012
91485388|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.008
91485389|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.009
91485390|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.029
91485391|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
91485392|NCT01325623|182844027|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
91485393|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.500
91485394|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.500
91485395|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
91485396|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
91485397|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
91485398|NCT01325623|182844027|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
91485399|NCT01325623|182844027|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||>0.999
91485400|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.125
91485401|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.500
91485402|NCT01325623|182844027|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
91485403|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1529|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.1529
91485404|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.0942|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0942
91485405|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.2831|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2831
91671354|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.103||0.6406||95.0|-0.252|0.155|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.155|-0.252|0.6406
91671355|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.092||0.2404||95.0|-0.289|0.073|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.073|-0.289|0.2404
91671356|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.09||0.1005||95.0|-0.327|0.029|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.029|-0.327|0.1005
91671357|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.136|STANDARD_ERROR_OF_MEAN|0.108||0.2109||95.0|-0.349|0.078|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.078|-0.349|0.2109
91671358|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.108||0.2399||95.0|-0.342|0.086|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.086|-0.342|0.2399
91671359|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.131|STANDARD_ERROR_OF_MEAN|0.108||0.2272||95.0|-0.346|0.083|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.083|-0.346|0.2272
91671360|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.4417||95.0|-0.285|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.125|-0.285|0.4417
91671361|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.144||0.9502||95.0|-0.299|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.281|-0.299|0.9502
91671362|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.144||0.355||95.0|-0.426|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.156|-0.426|0.3550
91671363|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.092||0.1888||95.0|-0.304|0.06|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.060|-0.304|0.1888
91671364|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.092||0.3774||95.0|-0.262|0.1|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.100|-0.262|0.3774
91671365|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.087||0.9452||95.0|-0.178|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.166|-0.178|0.9452
91671366|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.089||0.7663||95.0|-0.201|0.148|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.148|-0.201|0.7663
91715347|NCT01249417|183321840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.38||||0.0029|TWO_SIDED|95.0|-0.64|-0.13|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.13|-0.64|0.0029
91715348|NCT01249417|183321840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.49||||0.0002|TWO_SIDED|95.0|-0.75|-0.23|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.23|-0.75|0.0002
91715349|NCT01249417|183321841|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.82|||<|0.0001|TWO_SIDED|95.0|0.5|1.14|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.14|0.50|<0.0001
91715350|NCT01249417|183321841|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.77|||<|0.0001|TWO_SIDED|95.0|0.45|1.1|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.10|0.45|<0.0001
91792803|NCT02751931|183463233|OTHER||Mean Difference (Net)|54.3||||0.021|TWO_SIDED|95.0|9.0|99.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.6|9.0|0.021
91671367|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5777||95.0|-0.104|0.186|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.186|-0.104|0.5777
91671368|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.075||0.2916||95.0|-0.069|0.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.227|-0.069|0.2916
91671369|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.069||0.8389||95.0|-0.15|0.122|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.122|-0.150|0.8389
91671370|NCT00442546|183238151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.07||0.0734||95.0|-0.012|0.266|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.266|-0.012|0.0734
91715351|NCT01249417|183321842|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|5.32||||0.0006|TWO_SIDED|95.0|2.31|8.32|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||8.32|2.31|0.0006
91715352|NCT01249417|183321842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.65||||0.0031|TWO_SIDED|95.0|1.59|7.71|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||7.71|1.59|0.0031
91792804|NCT02751931|183463234|OTHER||Mean Difference (Net)|18.13||||0.113|TWO_SIDED|95.0|-4.5|40.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.7|-4.5|0.113
91671371|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1949||95.0|-0.276|0.057|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.057|-0.276|0.1949
91671372|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.085||0.5431||95.0|-0.22|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.116|-0.220|0.5431
91671373|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.077||0.2164||95.0|-0.247|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.056|-0.247|0.2164
91671374|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.076||0.1251||95.0|-0.266|0.033|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.033|-0.266|0.1251
91671375|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.088||0.4079||95.0|-0.247|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.101|-0.247|0.4079
91671376|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.088||0.4562||95.0|-0.24|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.108|-0.240|0.4562
91715353|NCT01854697|183321843|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|14.7|||||TWO_SIDED|95.0|1.3|28.2|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||28.2|1.3|
91715354|NCT01854697|183321843|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
91792805|NCT02751931|183463234|OTHER||Mean Difference (Net)|35.58||||0.056|TWO_SIDED|95.0|-1.1|72.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||72.2|-1.1|0.056
91526352|NCT02307513|182927888|SUPERIORITY||Adjusted difference in percentages|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||43.1|18.1|<0.0001
91671377|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.093||0.4526||95.0|-0.254|0.114|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.114|-0.254|0.4526
91671378|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.089||0.6186||95.0|-0.221|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.132|-0.221|0.6186
91671379|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.109||0.8712||95.0|-0.237|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.202|-0.237|0.8712
91671380|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.11||0.4784||95.0|-0.3|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.143|-0.300|0.4784
91671381|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.075||0.2635||95.0|-0.232|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.064|-0.232|0.2635
91671382|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.075||0.6009||95.0|-0.187|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.108|-0.187|0.6009
91671383|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.073||0.8559||95.0|-0.13|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.156|-0.130|0.8559
91671384|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.074||0.9841||95.0|-0.147|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.144|-0.147|0.9841
91671385|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.061||0.6771||95.0|-0.095|0.146|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.146|-0.095|0.6771
91671386|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.062||0.3717||95.0|-0.067|0.178|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.178|-0.067|0.3717
91671387|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.058||0.9863||95.0|-0.114|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.116|-0.114|0.9863
91671388|NCT00442546|183238152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.059||0.0355||95.0|0.009|0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.243|0.009|0.0355
91671389|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.202||0.8071||95.0|-0.35|0.449|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.449|-0.350|0.8071
91671390|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.204||0.8282||95.0|-0.359|0.447|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.447|-0.359|0.8282
91671391|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.192||0.8972||95.0|-0.353|0.403|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.403|-0.353|0.8972
91671392|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.19||0.8159||95.0|-0.329|0.418|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.418|-0.329|0.8159
91671393|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.188||0.8577||95.0|-0.337|0.405|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.405|-0.337|0.8577
91671394|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.188||0.8158||95.0|-0.415|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-0.415|0.8158
91671395|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.195||0.4243||95.0|-0.229|0.541|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.541|-0.229|0.4243
91671396|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.187||0.2742||95.0|-0.164|0.574|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.574|-0.164|0.2742
91671397|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.116||0.5569||95.0|-0.302|0.165|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.165|-0.302|0.5569
91671398|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.116||0.3762||95.0|-0.13|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.336|-0.130|0.3762
91671399|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.155||0.6203||95.0|-0.229|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.383|-0.229|0.6203
91671400|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.155||0.3343||95.0|-0.155|0.455|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.455|-0.155|0.3343
91671401|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.128||0.2213||95.0|-0.096|0.41|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.410|-0.096|0.2213
91671402|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.131||0.2863||95.0|-0.118|0.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.399|-0.118|0.2863
91671403|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.082||0.305||95.0|-0.077|0.245|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.245|-0.077|0.3050
91485406|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.3639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.3639
91671404|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.083||0.0155||95.0|0.039|0.368|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.368|0.039|0.0155
91485407|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.447|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.4470
91671405|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.087||0.9243||95.0|-0.164|0.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.181|-0.164|0.9243
91671406|NCT00442546|183238153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.089||0.0201||95.0|0.033|0.386|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.386|0.033|0.0201
91671407|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.321||0.1537||95.0|-1.093|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.173|-1.093|0.1537
91671408|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.398|STANDARD_ERROR_OF_MEAN|0.324||0.2208||95.0|-1.038|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.241|-1.038|0.2208
91671409|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.325||0.8355||95.0|-0.707|0.572|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.572|-0.707|0.8355
91671410|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.331||0.5024||95.0|-0.875|0.43|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.430|-0.875|0.5024
91671411|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.282||0.8116||95.0|-0.489|0.624|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.624|-0.489|0.8116
91671412|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.288||0.7325||95.0|-0.667|0.469|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.469|-0.667|0.7325
91671413|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.278||0.8133||95.0|-0.614|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.614|0.8133
91671414|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.285||0.9307||95.0|-0.588|0.538|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.538|-0.588|0.9307
91671415|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.439||0.2682||95.0|-1.364|0.385|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.385|-1.364|0.2682
91671416|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.294|STANDARD_ERROR_OF_MEAN|0.413||0.4784||95.0|-1.116|0.528|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.528|-1.116|0.4784
91671417|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.661|STANDARD_ERROR_OF_MEAN|0.298||0.0255||95.0|0.084|1.239|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.239|0.084|0.0255
91671418|NCT00442546|183238154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.448|STANDARD_ERROR_OF_MEAN|0.314||0.1591||95.0|-0.18|1.076|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.076|-0.180|0.1591
91671419|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.372||0.0359||95.0|-1.52|-0.052|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.052|-1.520|0.0359
91671420|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.907|STANDARD_ERROR_OF_MEAN|0.374||0.0161||95.0|-1.644|-0.17|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.170|-1.644|0.0161
91671421|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.319||0.7416||95.0|-0.733|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.523|-0.733|0.7416
91671422|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.324||0.3527||95.0|-0.939|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.336|-0.939|0.3527
91671423|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.184|STANDARD_ERROR_OF_MEAN|0.3||0.5419||95.0|-0.776|0.409|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.409|-0.776|0.5419
91671424|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.305||0.9333||95.0|-0.628|0.577|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.577|-0.628|0.9333
91671425|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.354|STANDARD_ERROR_OF_MEAN|0.24||0.142||95.0|-0.827|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.120|-0.827|0.1420
91671426|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.245||0.829||95.0|-0.535|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.429|-0.535|0.8290
91671427|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.111|STANDARD_ERROR_OF_MEAN|0.441||0.0138||95.0|-1.989|-0.233|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||-0.233|-1.989|0.0138
91671428|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.416||0.23||95.0|-1.332|0.325|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.325|-1.332|0.2300
91792806|NCT02751931|183463234|OTHER||Mean Difference (Net)|37.71||||0.005|TWO_SIDED|95.0|11.7|63.7|||t-test, 2 sided|From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.||Change From Baseline at Week 4 - Children||63.7|11.7|0.005
91792807|NCT02751931|183463234|OTHER||Mean Difference (Net)|70.35||||0.006|TWO_SIDED|95.0|22.2|118.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||118.5|22.2|0.006
91526353|NCT02307513|182927889|SUPERIORITY||Difference in LS Mean|-3.0||||0.0003|TWO_SIDED|95.0|-4.5|-1.4|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-1.4|-4.5|0.0003
91526354|NCT02307513|182927890|SUPERIORITY||Adjusted difference in percentages|28.4||||0.11|TWO_SIDED|95.0|-3.6|60.4|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex.|Adjusted difference was the weighted average of the treatment differences across the 2 strata of sex with the CMH weights.|||60.4|-3.6|0.1100
91526355|NCT02307513|182927891|SUPERIORITY||Adjusted difference in percentages|17.5||||0.0204|TWO_SIDED|95.0|4.2|30.7|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test, adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||30.7|4.2|0.0204
91526356|NCT02307513|182927892|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0112|TWO_SIDED|95.0|0.408|0.915|||Stratified Log Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors|||0.915|0.408|0.0112
91671429|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.268||0.5151||95.0|-0.36|0.711|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||0.711|-0.360|0.5151
91671430|NCT00442546|183238155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.295||0.146||95.0|-0.155|1.022|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.022|-0.155|0.1460
91671431|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258|STANDARD_ERROR_OF_MEAN|0.463||0.5786||95.0|-1.17|0.655|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.655|-1.170|0.5786
91671432|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.467||0.957||95.0|-0.895|0.946|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.946|-0.895|0.9570
91671433|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.434||0.986||95.0|-0.862|0.847|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.847|-0.862|0.9860
91671434|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.151|STANDARD_ERROR_OF_MEAN|0.442||0.7336||95.0|-1.021|0.72|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.720|-1.021|0.7336
91671435|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.384|STANDARD_ERROR_OF_MEAN|0.365||0.2939||95.0|-0.336|1.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.104|-0.336|0.2939
91671436|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.372||0.4615||95.0|-0.459|1.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.008|-0.459|0.4615
91671437|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.347||0.6433||95.0|-0.845|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.523|-0.845|0.6433
91671438|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.356||0.9466||95.0|-0.678|0.726|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.726|-0.678|0.9466
91715355|NCT01854697|183321844|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|2.28||0.351|TWO_SIDED|95.0|-2.39|6.65|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||6.65|-2.39|0.351
91715356|NCT01854697|183321844|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.83|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|2.19|9.47|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.47|2.19|0.002
91715357|NCT01854697|183321844|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.28|STANDARD_ERROR_OF_MEAN|1.65||0.002|TWO_SIDED|95.0|2.01|8.54|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.54|2.01|0.002
91715358|NCT01854697|183321845|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.08|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|2.72|9.44|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.44|2.72|<0.001
91715359|NCT01854697|183321845|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|3.55|8.85|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.85|3.55|<0.001
91715360|NCT01854697|183321845|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|4.36|9.37|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.37|4.36|<0.001
91715361|NCT01854697|183321846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2||||0.021|TWO_SIDED|95.0|1.4|38.0|||Regression, Logistic|Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.||||38.0|1.4|0.021
91792808|NCT02751931|183463234|OTHER||Mean Difference (Net)|43.91|||<|0.001|TWO_SIDED|95.0|21.0|66.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||66.8|21.0|<0.001
91792809|NCT02751931|183463234|OTHER||Mean Difference (Net)|38.11||||0.063|TWO_SIDED|95.0|-2.2|78.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.4|-2.2|0.063
91792810|NCT02751931|183463234|OTHER||Mean Difference (Net)|29.05||||0.008|TWO_SIDED|95.0|8.2|49.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||49.9|8.2|0.008
91485408|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1311|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1311
91485409|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.3898|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.3898
91485410|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0511
91485411|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0019
91485412|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.1106
91485413|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1273
91485414|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1305|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.1305
91485415|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1123
91485416|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.2309|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.2309
91485417|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.3191|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3191
91485418|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0679
91485419|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.2082|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2082
91485420|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1790
91485421|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.6869|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.6869
91485422|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.6094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.6094
91485423|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.1530
91526357|NCT02307513|182927893|SUPERIORITY||Difference in LS Means|-0.4||||0.0683|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|ANCOVA model with treatment group, sex and region as factors and the baseline ulcers number as a covariate.||||0.0|-0.9|0.0683
91526358|NCT02307513|182927894|SUPERIORITY||Difference in LS Mean|-0.1||||0.5944|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||0.3|-0.4|0.5944
91715362|NCT01854697|183321846|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|20.8|||||TWO_SIDED|95.0|7.9|33.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||33.6|7.9|
91715363|NCT01854697|183321846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.2||||0.002|TWO_SIDED|95.0|3.3|241.1|||Regression, Logistic|Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.||||241.1|3.3|0.002
91715364|NCT01854697|183321846|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).||||||0.005
91715365|NCT01854697|183321849|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|13.3|||||TWO_SIDED|95.0|-0.4|27.0|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||27.0|-0.4|
91715366|NCT01854697|183321849|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.6|||||TWO_SIDED|95.0|6.5|32.7|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.7|6.5|
91715367|NCT01854697|183321849|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
91715368|NCT01421498|183321890|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.24||||0.0007|TWO_SIDED|95.0|0.1|0.38|||t-test, 2 sided|||||0.38|0.10|0.0007
91715369|NCT01421498|183321891|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.02||||0.786|TWO_SIDED|95.0|-0.15|0.11|||t-test, 2 sided|||||0.11|-0.15|0.7860
91792811|NCT02751931|183463234|OTHER||Mean Difference (Net)|43.04||||0.009|TWO_SIDED|95.0|11.9|74.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||74.2|11.9|0.009
91526359|NCT02307513|182927895|SUPERIORITY||Difference in LS Mean|-5.5||||0.6182|TWO_SIDED|95.0|-27.6|16.7|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||16.7|-27.6|0.6182
91526360|NCT01107743|182927925|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.812|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.812
91715370|NCT03933449|183321918|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0015|TWO_SIDED|95.0|0.36|0.82||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.82|0.36|0.0015
91715371|NCT03933449|183321919|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0008|TWO_SIDED|95.0|0.17|0.69||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.69|0.17|0.0008
91715372|NCT03933449|183321920|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0021|TWO_SIDED|95.0|0.37|0.83||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.83|0.37|0.0021
91715373|NCT03933449|183321921|SUPERIORITY||Difference in Percentages|12.9||||0.0084|TWO_SIDED|95.0|2.7|24.5||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||24.5|2.7|0.0084
91715374|NCT03933449|183321922|SUPERIORITY||Difference in Percentages|17.1||||0.0403|TWO_SIDED|95.0|-2.3|38.0||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||38.0|-2.3|0.0403
91715375|NCT03933449|183321923|SUPERIORITY||Difference in Percentages|13.3||||0.0083|TWO_SIDED|95.0|2.8|25.2||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||25.2|2.8|0.0083
91715376|NCT03933449|183321924|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.177|TWO_SIDED|95.0|0.58|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.58|0.177
91715377|NCT03933449|183321925|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.238|TWO_SIDED|95.0|0.44|1.46||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.46|0.44|0.238
91715378|NCT03933449|183321926|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.171|TWO_SIDED|95.0|0.57|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.57|0.171
91715379|NCT00501631|183321929|SUPERIORITY_OR_OTHER|||||||0.336||95.0|||||Van der Waerden test|||The null hypothesis that there is no difference between two treatment groups (i.e. Placebo and Vivitrol) was tested using a two-sided Van der Waerden test. Response profiles were tabulated as a cumulative percent of subjects at each decile of percent heavy drinking days.||||0.336
91715380|NCT02858401|183321939|OTHER|||||||0.1498|||||||Wilcoxon rank sum test|||||||0.1498
91715381|NCT02858401|183321939|OTHER|||||||0.064|||||||Wilcoxon rank sum test|||||||0.0640
91715382|NCT02858401|183321939|OTHER|||||||0.2807|||||||Wilcoxon rank sum test|||||||0.2807
91715383|NCT02858401|183321939|OTHER|||||||0.1228|||||||Wilcoxon rank sum test|||||||0.1228
91715384|NCT02858401|183321939|OTHER|||||||0.0289|||||||Wilcoxon rank sum test|||||||0.0289
91715385|NCT02858401|183321939|OTHER|||||||0.5895|||||||Wilcoxon rank sum test|||||||0.5895
91715386|NCT02858401|183321940|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715387|NCT02858401|183321940|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91485424|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.3339|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3339
91526361|NCT01107743|182927926|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
91526362|NCT01107743|182927927|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
91671439|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.621||0.4967||95.0|-1.66|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.812|-1.660|0.4967
91671440|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.582||0.8659||95.0|-1.06|1.257|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.257|-1.060|0.8659
91671441|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.994|STANDARD_ERROR_OF_MEAN|0.451||0.0311||95.0|0.093|1.895|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.895|0.093|0.0311
91671442|NCT00442546|183238156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.995|STANDARD_ERROR_OF_MEAN|0.485||0.0441||95.0|0.027|1.962|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.962|0.027|0.0441
91671443|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.969|STANDARD_ERROR_OF_MEAN|0.439||0.0284||95.0|-1.835|-0.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.104|-1.835|0.0284
91715388|NCT02858401|183321940|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715389|NCT02858401|183321941|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
91715390|NCT02858401|183321941|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
91792812|NCT02751931|183463234|OTHER||Mean Difference (Net)|44.2||||0.006|TWO_SIDED|95.0|13.2|75.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||75.2|13.2|0.006
91485425|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.1473|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.1473
91485426|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.5035|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5035
91526363|NCT01107743|182927928|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.112
91526364|NCT01107743|182927929|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.093|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.093
91671444|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.444||0.5516||95.0|-1.141|0.611|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.611|-1.141|0.5516
91671445|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.38||0.479||95.0|-1.02|0.48|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.480|-1.020|0.4790
91671446|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.39||0.9947||95.0|-0.765|0.77|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.770|-0.765|0.9947
91671447|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.329||0.8943||95.0|-0.605|0.692|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.692|-0.605|0.8943
91671448|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.336||0.9767||95.0|-0.674|0.654|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.654|-0.674|0.9767
91715391|NCT02858401|183321941|OTHER|||||||0.8288|||||||Wilcoxon rank sum test|||||||0.8288
91715392|NCT02858401|183321941|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
91715393|NCT02858401|183321941|OTHER|||||||0.6056|||||||Wilcoxon rank sum test|||||||0.6056
91715394|NCT02858401|183321941|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
91715395|NCT02858401|183321942|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715396|NCT02858401|183321942|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715397|NCT02858401|183321942|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715398|NCT02858401|183321943|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715399|NCT02858401|183321943|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715400|NCT02858401|183321943|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
91715401|NCT02858401|183321943|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715402|NCT02858401|183321943|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715403|NCT02858401|183321943|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715404|NCT02858401|183321944|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715405|NCT02858401|183321944|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715406|NCT02858401|183321944|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
91715407|NCT02858401|183321945|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715408|NCT02858401|183321945|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715409|NCT02858401|183321945|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
91792813|NCT02751931|183463234|OTHER||Mean Difference (Net)|81.37||||0.003|TWO_SIDED|95.0|30.4|132.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||132.3|30.4|0.003
91671449|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.34||0.8117||95.0|-0.59|0.752|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.752|-0.590|0.8117
91671450|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.125|STANDARD_ERROR_OF_MEAN|0.351||0.7216||95.0|-0.818|0.567|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.567|-0.818|0.7216
91671451|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.592||0.8558||95.0|-1.286|1.07|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.070|-1.286|0.8558
91671452|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.422|STANDARD_ERROR_OF_MEAN|0.556||0.4501||95.0|-1.53|0.685|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.685|-1.530|0.4501
91671453|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.328|STANDARD_ERROR_OF_MEAN|0.45||0.4682||95.0|-0.57|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.570|0.4682
91671454|NCT00442546|183238157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.492||0.5347||95.0|-0.675|1.289|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.289|-0.675|0.5347
91671455|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.407||0.0613||95.0|-1.568|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.037|-1.568|0.0613
91671456|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.936|STANDARD_ERROR_OF_MEAN|0.409||0.023||95.0|-1.741|-0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.130|-1.741|0.0230
91671457|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.4||0.8306||95.0|-0.703|0.875|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.875|-0.703|0.8306
91671458|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.439|STANDARD_ERROR_OF_MEAN|0.407||0.2814||95.0|-1.242|0.363|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.363|-1.242|0.2814
91671459|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.353||0.8637||95.0|-0.636|0.757|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.757|-0.636|0.8637
91671460|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.359||0.9585||95.0|-0.727|0.689|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.689|-0.727|0.9585
91671461|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.272|STANDARD_ERROR_OF_MEAN|0.321||0.3975||95.0|-0.906|0.361|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.361|-0.906|0.3975
91671462|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.327||0.6386||95.0|-0.799|0.491|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.491|-0.799|0.6386
91671463|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.702|STANDARD_ERROR_OF_MEAN|0.397||0.0813||95.0|-1.493|0.089|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.089|-1.493|0.0813
91671464|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.37||0.31||95.0|-1.114|0.358|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.358|-1.114|0.3100
91671465|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.831|STANDARD_ERROR_OF_MEAN|0.357||0.0231||95.0|0.118|1.545|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.545|0.118|0.0231
91671466|NCT00442546|183238158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.388||0.2367||95.0|-0.311|1.237|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.237|-0.311|0.2367
91671467|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.448||0.8868||95.0|-0.947|0.82|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.820|-0.947|0.8868
91671468|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.254|STANDARD_ERROR_OF_MEAN|0.45||0.5733||95.0|-1.142|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.634|-1.142|0.5733
91671469|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.384||0.7385||95.0|-0.884|0.628|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.628|-0.884|0.7385
91671470|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.39||0.8353||95.0|-0.849|0.687|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.687|-0.849|0.8353
91671471|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.362||0.5737||95.0|-0.51|0.918|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.918|-0.510|0.5737
91637260|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-6.05|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-14.79|2.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||2.69|-14.79|
91637261|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-10.51|7.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.79|-10.51|
91637262|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-4.95|STANDARD_ERROR_OF_MEAN|4.11|||TWO_SIDED|95.0|-13.5|3.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.60|-13.50|
91671472|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.335|STANDARD_ERROR_OF_MEAN|0.368||0.364||95.0|-1.06|0.391|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.391|-1.060|0.3640
91671473|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.332||0.4315||95.0|-0.393|0.917|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.917|-0.393|0.4315
91671474|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.339||0.6727||95.0|-0.525|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.812|-0.525|0.6727
91671475|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.489|STANDARD_ERROR_OF_MEAN|0.505||0.3361||95.0|-1.496|0.517|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.517|-1.496|0.3361
91671476|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.469||0.9634||95.0|-0.955|0.912|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.912|-0.955|0.9634
91671477|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.446|STANDARD_ERROR_OF_MEAN|0.352||0.2098||95.0|-0.257|1.15|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.150|-0.257|0.2098
91671478|NCT00442546|183238159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.382||0.49||95.0|-0.497|1.027|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.027|-0.497|0.4900
91671479|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.546||0.9912||95.0|-1.07|1.082|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||1.082|-1.070|0.9912
91671480|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.554||0.8076||95.0|-1.227|0.957|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.957|-1.227|0.8076
91671481|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.46||0.6978||95.0|-0.727|1.085|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.085|-0.727|0.6978
91671482|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.47||0.5344||95.0|-1.219|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.634|-1.219|0.5344
91671483|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.384||0.8721||95.0|-0.819|0.695|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.695|-0.819|0.8721
91671484|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.394||0.3179||95.0|-1.173|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.383|-1.173|0.3179
91671485|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.376||0.8037||95.0|-0.648|0.835|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.835|-0.648|0.8037
91671486|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7731||95.0|-0.656|0.881|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.881|-0.656|0.7731
91671487|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.468|STANDARD_ERROR_OF_MEAN|0.611||0.4461||95.0|-1.684|0.748|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.748|-1.684|0.4461
91671488|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.575||0.3568||95.0|-1.679|0.612|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.612|-1.679|0.3568
91671489|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.598|STANDARD_ERROR_OF_MEAN|0.315||0.0623||95.0|-0.032|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.032|0.0623
91671490|NCT00442546|183238160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.343||0.3529||95.0|-0.364|1.005|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.005|-0.364|0.3529
91671491|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.611|STANDARD_ERROR_OF_MEAN|0.417||0.1448||95.0|-1.434|0.212|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.212|-1.434|0.1448
91671492|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.665|STANDARD_ERROR_OF_MEAN|0.42||0.1148||95.0|-1.494|0.163|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.163|-1.494|0.1148
91671493|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.448|STANDARD_ERROR_OF_MEAN|0.458||0.3285||95.0|-1.35|0.454|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.454|-1.350|0.3285
91671494|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.572|STANDARD_ERROR_OF_MEAN|0.466||0.2205||95.0|-1.49|0.346|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.346|-1.490|0.2205
91671495|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.389||0.6266||95.0|-0.958|0.578|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.578|-0.958|0.6266
91671496|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.502|STANDARD_ERROR_OF_MEAN|0.397||0.2077||95.0|-1.284|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.281|-1.284|0.2077
91671497|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.223|STANDARD_ERROR_OF_MEAN|0.385||0.5626||95.0|-0.982|0.536|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.536|-0.982|0.5626
91671498|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.368|STANDARD_ERROR_OF_MEAN|0.394||0.3507||95.0|-1.145|0.408|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.408|-1.145|0.3507
91485427|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.6653|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.6653
91671499|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.224|STANDARD_ERROR_OF_MEAN|0.64||0.7276||95.0|-1.498|1.05|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.050|-1.498|0.7276
91671500|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.598||0.353||95.0|-1.748|0.631|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.631|-1.748|0.3530
91715410|NCT02858401|183321945|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715411|NCT02858401|183321945|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91526365|NCT01107743|182927930|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
91526366|NCT01107743|182927931|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.839|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.839
91526367|NCT01107743|182927932|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
91671501|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.186|STANDARD_ERROR_OF_MEAN|0.529||0.0283||95.0|0.13|2.242|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||2.242|0.130|0.0283
91671502|NCT00442546|183238161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.573||0.6934||95.0|-0.918|1.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.372|-0.918|0.6934
91526368|NCT01107743|182927933|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
91671503|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.553|STANDARD_ERROR_OF_MEAN|0.77||0.0476||95.0|-3.089|-0.017|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.017|-3.089|0.0476
91671504|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|STANDARD_ERROR_OF_MEAN|0.764||0.0237||95.0|-3.293|-0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.243|-3.293|0.0237
91671505|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.402||0.4925||95.0|-0.516|1.069|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||1.069|-0.516|0.4925
91671506|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.414||0.8299||95.0|-0.727|0.905|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.905|-0.727|0.8299
91671507|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.691|-0.766|0.9185
91526369|NCT01107743|182927934|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.644|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.644
91526370|NCT01107743|182927935|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.155|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.155
91671508|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.392|-1.070|0.3619
91671509|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.453||0.4309||95.0|-0.538|1.254|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.254|-0.538|0.4309
91671510|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.459||0.9778||95.0|-0.895|0.921|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.921|-0.895|0.9778
91671511|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.777||0.8503||95.0|-1.411|1.706|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.706|-1.411|0.8503
91671512|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.845|STANDARD_ERROR_OF_MEAN|0.757||0.0183||95.0|-3.364|-0.326|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.326|-3.364|0.0183
91671513|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.141|STANDARD_ERROR_OF_MEAN|0.956||0.286||95.0|-3.598|1.316|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||1.316|-3.598|0.2860
91671514|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|1.856||0.204||95.0|-7.479|2.06|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.060|-7.479|0.2040
91671515|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.295||0.6332||95.0|-0.722|0.44|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.440|-0.722|0.6332
91671516|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.303||0.5183||95.0|-0.402|0.794|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.794|-0.402|0.5183
91671517|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.306||0.6341||95.0|-0.75|0.458|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.458|-0.750|0.6341
91671518|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|0.32||0.4607||95.0|-0.868|0.395|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.395|-0.868|0.4607
91671519|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.327||0.7499||95.0|-0.541|0.75|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.750|-0.541|0.7499
91671520|NCT00442546|183238162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.333||0.8231||95.0|-0.584|0.733|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.733|-0.584|0.8231
91715412|NCT02858401|183321945|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91671521|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.709||0.1486||95.0|-2.452|0.379|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.379|-2.452|0.1486
91671522|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.903|STANDARD_ERROR_OF_MEAN|0.706||0.0089||95.0|-3.311|-0.494|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.494|-3.311|0.0089
91671523|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.344||0.8995||95.0|-0.635|0.722|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.722|-0.635|0.8995
91671524|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.303|STANDARD_ERROR_OF_MEAN|0.354||0.3918||95.0|-1.0|0.394|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.394|-1.000|0.3918
91671525|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.33||0.9942||95.0|-0.648|0.652|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.652|-0.648|0.9942
91792814|NCT02751931|183463234|OTHER||Mean Difference (Net)|58.49||||0.004|TWO_SIDED|95.0|19.8|97.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||97.2|19.8|0.004
91485428|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.8622
91485429|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.4456|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.4456
91485430|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.6876|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.6876
91526371|NCT01107743|182927936|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.305|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.305
91671526|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.332||0.5352||95.0|-0.859|0.448|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.448|-0.859|0.5352
91671527|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.382||0.8055||95.0|-0.662|0.85|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.850|-0.662|0.8055
91671528|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.446|STANDARD_ERROR_OF_MEAN|0.391||0.256||95.0|-1.22|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-1.220|0.2560
91671529|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.641||0.8744||95.0|-1.184|1.387|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.387|-1.184|0.8744
91671530|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.614|STANDARD_ERROR_OF_MEAN|0.616||0.0115||95.0|-2.851|-0.378|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.378|-2.851|0.0115
91671531|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.155||0.9497||95.0|-3.047|2.893|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.893|-3.047|0.9497
91671532|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.347|STANDARD_ERROR_OF_MEAN|1.992||0.5288||95.0|-6.467|3.773|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||3.773|-6.467|0.5288
91485431|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.0328|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0328
91485432|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0067
91485433|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.5928|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5928
91485434|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.7179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.7179
91485435|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.5014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.5014
91671533|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.262||0.2595||95.0|-0.813|0.22|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.220|-0.813|0.2595
91671534|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.27||0.9605||95.0|-0.546|0.519|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.519|-0.546|0.9605
91671535|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.207|STANDARD_ERROR_OF_MEAN|0.251||0.4107||95.0|-0.702|0.288|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.288|-0.702|0.4107
91671536|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.263||0.2271||95.0|-0.836|0.2|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.200|-0.836|0.2271
91715413|NCT02858401|183321946|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715414|NCT02858401|183321946|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91792815|NCT02751931|183463234|OTHER||Mean Difference (Net)|50.9||||0.039|TWO_SIDED|95.0|2.7|99.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||99.1|2.7|0.039
91671537|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.263||0.9552||95.0|-0.535|0.506|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.506|-0.535|0.9552
91671538|NCT00442546|183238163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.268||0.9899||95.0|-0.533|0.526|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.526|-0.533|0.9899
91671539|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.578|STANDARD_ERROR_OF_MEAN|0.471||0.2211||95.0|-0.35|1.506|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||1.506|-0.350|0.2211
91671540|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.477||0.0916||95.0|-1.75|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||0.132|-1.750|0.0916
91671541|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.42||0.9312||95.0|-0.863|0.791|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.791|-0.863|0.9312
91671542|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.591|STANDARD_ERROR_OF_MEAN|0.425||0.1658||95.0|-1.428|0.247|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.247|-1.428|0.1658
91671543|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.483||0.9921||95.0|-0.958|0.948|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.948|-0.958|0.9921
91671544|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.715|STANDARD_ERROR_OF_MEAN|0.479||0.1367||95.0|-1.66|0.229|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.229|-1.660|0.1367
91715415|NCT02858401|183321946|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715416|NCT02858401|183321947|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91671545|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.364||0.3561||95.0|-1.053|0.38|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.380|-1.053|0.3561
91671546|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.366||0.426||95.0|-1.012|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.429|-1.012|0.4260
91671547|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.41||0.7975||95.0|-0.703|0.914|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.914|-0.703|0.7975
91671548|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.412||0.6947||95.0|-0.65|0.974|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.974|-0.650|0.6947
91671549|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.465||0.6954||95.0|-1.101|0.736|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.736|-1.101|0.6954
91671550|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.481||0.8665||95.0|-1.032|0.87|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.870|-1.032|0.8665
91671551|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.386||0.4216||95.0|-0.45|1.072|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.072|-0.450|0.4216
91671552|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.391||0.4673||95.0|-0.487|1.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.056|-0.487|0.4673
91671553|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.44||0.5624||95.0|-0.614|1.125|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||1.125|-0.614|0.5624
91671554|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.448||0.3705||95.0|-1.286|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||0.482|-1.286|0.3705
91671555|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.358|STANDARD_ERROR_OF_MEAN|0.476||0.4539||95.0|-1.302|0.586|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||0.586|-1.302|0.4539
91671556|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.086|STANDARD_ERROR_OF_MEAN|0.515||0.0373||95.0|-2.107|-0.065|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||-0.065|-2.107|0.0373
91671557|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.476||0.76||95.0|-0.796|1.087|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.087|-0.796|0.7600
91671558|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.555|STANDARD_ERROR_OF_MEAN|0.481||0.2506||95.0|-1.507|0.397|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.397|-1.507|0.2506
91671559|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.895||0.2567||95.0|-0.77|2.823|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||2.823|-0.770|0.2567
91671560|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.882|STANDARD_DEVIATION|0.76||0.0167||95.0|-3.408|-0.356|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||-0.356|-3.408|0.0167
91715417|NCT02858401|183321947|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715418|NCT02858401|183321947|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715419|NCT02858401|183321948|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715420|NCT02858401|183321948|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715421|NCT02858401|183321948|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
91715422|NCT02858401|183321948|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715423|NCT02858401|183321948|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715424|NCT02858401|183321948|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715425|NCT02858401|183321949|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715426|NCT02858401|183321949|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715427|NCT02858401|183321949|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91526372|NCT01107743|182927937|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.234
91671561|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.89||0.6953||95.0|-1.456|2.159|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||2.159|-1.456|0.6953
91671562|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.147|STANDARD_ERROR_OF_MEAN|0.894||0.208||95.0|-2.962|0.668|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||0.668|-2.962|0.2080
91671563|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.867|STANDARD_ERROR_OF_MEAN|0.975||0.3805||95.0|-1.116|2.849|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.849|-1.116|0.3805
91671564|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.905||0.89||95.0|-1.965|1.713|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.713|-1.965|0.8900
91671565|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.672|STANDARD_ERROR_OF_MEAN|1.08||0.1821||95.0|-1.103|4.448|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||4.448|-1.103|0.1821
91671566|NCT00442546|183238164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.851|STANDARD_ERROR_OF_MEAN|1.768||0.6505||95.0|-3.693|5.395|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||5.395|-3.693|0.6505
91671567|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.029|STANDARD_ERROR_OF_MEAN|0.495||0.0388||95.0|-2.004|-0.053|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.053|-2.004|0.0388
91671568|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.501||0.0004||95.0|-2.798|-0.822|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.822|-2.798|0.0004
91671569|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.405||0.6274||95.0|-0.995|0.601|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.601|-0.995|0.6274
91671570|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.619|STANDARD_ERROR_OF_MEAN|0.413||0.135||95.0|-1.432|0.194|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.194|-1.432|0.1350
91671571|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.719|STANDARD_ERROR_OF_MEAN|0.448||0.1106||95.0|-1.605|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.166|-1.605|0.1106
91671572|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.457||0.0248||95.0|-1.939|-0.133|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||-0.133|-1.939|0.0248
91671573|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.725||0.2335||95.0|-0.582|2.33|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.330|-0.582|0.2335
91526373|NCT01107743|182927938|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.439|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.439
91671574|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.568|STANDARD_ERROR_OF_MEAN|0.682||0.0258||95.0|-2.939|-0.198|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.198|-2.939|0.0258
91671575|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.866|STANDARD_ERROR_OF_MEAN|1.973||0.3878||95.0|-3.207|6.939|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||6.939|-3.207|0.3878
91671576|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.909|STANDARD_ERROR_OF_MEAN|3.754||0.1762||95.0|-3.74|15.559|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.559|-3.740|0.1762
91671577|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.379||0.1754||95.0|-1.261|0.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.231|-1.261|0.1754
91671578|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.569|STANDARD_ERROR_OF_MEAN|0.386||0.1413||95.0|-1.329|0.191|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.191|-1.329|0.1413
91671579|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.419|STANDARD_ERROR_OF_MEAN|0.306||0.1731||95.0|-1.023|0.185|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.185|-1.023|0.1731
91671580|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.314||0.6829||95.0|-0.747|0.49|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.490|-0.747|0.6829
91671581|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.3||0.2436||95.0|-0.943|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.241|-0.943|0.2436
91671582|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.313||0.119||95.0|-1.108|0.127|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.127|-1.108|0.1190
91671583|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.264|STANDARD_ERROR_OF_MEAN|0.321||0.4117||95.0|-0.897|0.369|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.369|-0.897|0.4117
91671584|NCT00442546|183238165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.323||0.6294||95.0|-0.794|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.794|0.6294
91715428|NCT02858401|183321950|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
91715429|NCT02858401|183321950|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715430|NCT02858401|183321950|OTHER|||||||0.4278|||||||Wilcoxon rank sum test|||||||0.4278
91715431|NCT02858401|183321950|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715432|NCT02858401|183321950|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715433|NCT02858401|183321950|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91671585|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.859|STANDARD_ERROR_OF_MEAN|3.315||0.7958||95.0|-7.391|5.673|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||5.673|-7.391|0.7958
91671586|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|3.322||0.9733||95.0|-6.436|6.659|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||6.659|-6.436|0.9733
91671587|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.889|STANDARD_ERROR_OF_MEAN|3.946||0.822||95.0|-6.898|8.675|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||8.675|-6.898|0.8220
91671588|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.813|STANDARD_ERROR_OF_MEAN|3.917||0.4736||95.0|-10.542|4.917|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||4.917|-10.542|0.4736
91715434|NCT02858401|183321951|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91715435|NCT02858401|183321951|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
91715436|NCT02858401|183321951|OTHER|||||||0.1869|||||||Wilcoxon rank sum test|||||||0.1869
91715437|NCT02858401|183321951|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91715438|NCT02858401|183321951|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91792816|NCT02751931|183463234|OTHER||Mean Difference (Net)|53.76||||0.002|TWO_SIDED|95.0|21.7|85.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||85.8|21.7|0.002
91485436|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.9640
91671589|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.662|STANDARD_ERROR_OF_MEAN|4.045||0.5113||95.0|-10.639|5.316|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||5.316|-10.639|0.5113
91671590|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.365|STANDARD_ERROR_OF_MEAN|3.95||0.9266||95.0|-7.425|8.154|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||8.154|-7.425|0.9266
91671591|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|4.347||0.9699||95.0|-8.423|8.751|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.751|-8.423|0.9699
91671592|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|4.232||0.9482||95.0|-8.085|8.635|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.635|-8.085|0.9482
91671593|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.915|STANDARD_ERROR_OF_MEAN|7.391||0.7969||95.0|-16.842|13.012|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||13.012|-16.842|0.7969
91671594|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.023|STANDARD_ERROR_OF_MEAN|7.68||0.1991||95.0|-25.533|5.487|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||5.487|-25.533|0.1991
91671595|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.335|STANDARD_ERROR_OF_MEAN|22.737||0.0321||95.0|13.976|158.693|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||158.693|13.976|0.0321
91715439|NCT02858401|183321952|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
91715440|NCT02858401|183321952|OTHER|||||||0.4237|||||||Wilcoxon rank sum test|||||||0.4237
91715441|NCT02858401|183321952|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
91715442|NCT02858401|183321953|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
91715443|NCT02858401|183321953|OTHER|||||||0.3971|||||||Wilcoxon rank sum test|||||||0.3971
91715444|NCT02858401|183321953|OTHER|||||||0.1301|||||||Wilcoxon rank sum test|||||||0.1301
91715445|NCT02858401|183321953|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
91715446|NCT02858401|183321953|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
91715447|NCT02858401|183321953|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
91715448|NCT02858401|183321954|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715449|NCT02858401|183321954|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
91715450|NCT02858401|183321954|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
91715451|NCT02858401|183321955|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715452|NCT02858401|183321955|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715453|NCT02858401|183321955|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
91715454|NCT02858401|183321955|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715455|NCT02858401|183321955|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715456|NCT02858401|183321955|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715457|NCT02858401|183321956|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715458|NCT02858401|183321956|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715459|NCT02858401|183321956|OTHER|||||||0.2763|||||||Wilcoxon rank sum test|||||||0.2763
91715460|NCT02858401|183321956|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715461|NCT02858401|183321956|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715462|NCT02858401|183321957|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715463|NCT02858401|183321957|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715464|NCT02858401|183321957|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715465|NCT02858401|183321958|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715466|NCT02858401|183321958|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715467|NCT02858401|183321958|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
91715468|NCT02858401|183321958|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715469|NCT02858401|183321958|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715470|NCT02858401|183321958|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91792817|NCT02751931|183463234|OTHER||Mean Difference (Net)|49.13||||0.057|TWO_SIDED|95.0|-1.6|99.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.8|-1.6|0.057
91671596|NCT00442546|183238166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.964|STANDARD_ERROR_OF_MEAN|12.295||0.0353||95.0|5.837|84.091|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||84.091|5.837|0.0353
91671597|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.812|STANDARD_ERROR_OF_MEAN|12.055||0.5736||95.0|-30.792|17.169|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||17.169|-30.792|0.5736
91671598|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.991|STANDARD_ERROR_OF_MEAN|11.786||0.8003||95.0|-26.438|20.455|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||20.455|-26.438|0.8003
91671599|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.815|STANDARD_ERROR_OF_MEAN|10.371||0.5125||95.0|-27.369|13.74|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||13.740|-27.369|0.5125
91671600|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.294|STANDARD_ERROR_OF_MEAN|10.227||0.4773||95.0|-27.563|12.976|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||12.976|-27.563|0.4773
91671601|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.915|STANDARD_ERROR_OF_MEAN|11.101||0.2142||95.0|-36.055|8.226|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.226|-36.055|0.2142
91671602|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.769|STANDARD_ERROR_OF_MEAN|11.245||0.2989||95.0|-34.197|10.659|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||10.659|-34.197|0.2989
91671603|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.51|STANDARD_ERROR_OF_MEAN|45.612||0.3829||95.0|-53.429|134.449|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||134.449|-53.429|0.3829
91671604|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.25|STANDARD_ERROR_OF_MEAN|45.322||0.5531||95.0|-120.59|66.092|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||66.092|-120.59|0.5531
91671605|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.513|STANDARD_ERROR_OF_MEAN|8.491||0.2738||95.0|-89.376|126.402|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||126.402|-89.376|0.2738
91671606|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.644|STANDARD_ERROR_OF_MEAN|2.519||0.7987||95.0|-4.343|5.63|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.630|-4.343|0.7987
91671607|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|2.441||0.8875||95.0|-5.177|4.485|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||4.485|-5.177|0.8875
91671608|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.537|STANDARD_ERROR_OF_MEAN|1.949||0.4319||95.0|-2.324|5.398|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.398|-2.324|0.4319
91671609|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.935||0.407||95.0|-2.223|5.443|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.443|-2.223|0.4070
91671610|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.641||0.4968||95.0|-4.371|2.133|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.133|-4.371|0.4968
91671611|NCT00442546|183238167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.327|STANDARD_ERROR_OF_MEAN|1.665||0.427||95.0|-1.972|4.626|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||4.626|-1.972|0.4270
91671612|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.862|STANDARD_ERROR_OF_MEAN|2.999||0.7742||95.0|-6.775|5.052|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||5.052|-6.775|0.7742
91671613|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.006|STANDARD_ERROR_OF_MEAN|3.025||0.0996||95.0|-0.96|10.971|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||10.971|-0.960|0.0996
91671614|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.803|STANDARD_ERROR_OF_MEAN|2.79||0.7738||95.0|-4.698|6.304|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||6.304|-4.698|0.7738
91671615|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.192|STANDARD_ERROR_OF_MEAN|2.778||0.1328||95.0|-1.284|9.669|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.669|-1.284|0.1328
91671616|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|3.012||0.7585||95.0|-5.027|6.882|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||6.882|-5.027|0.7585
91671617|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.946|STANDARD_ERROR_OF_MEAN|2.997||0.19||95.0|-1.979|9.871|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||9.871|-1.979|0.1900
91671618|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|3.693||0.2365||95.0|-3.004|11.865|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||11.865|-3.004|0.2365
91671619|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.306|STANDARD_ERROR_OF_MEAN|3.73||0.1616||95.0|-2.202|12.814|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||12.814|-2.202|0.1616
91671620|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.071|STANDARD_ERROR_OF_MEAN|6.911||0.8819||95.0|-17.98|15.838|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.838|-17.98|0.8819
91671621|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.071|STANDARD_ERROR_OF_MEAN|11.7||0.4676||95.0|-37.7|19.558|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||19.558|-37.70|0.4676
91671622|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.925|STANDARD_ERROR_OF_MEAN|2.195||0.3813||95.0|-2.403|6.254|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.254|-2.403|0.3813
91671623|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.341|STANDARD_ERROR_OF_MEAN|2.236||0.2966||95.0|-2.07|6.751|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.751|-2.070|0.2966
91715471|NCT02858401|183321959|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91526374|NCT01107743|182927939|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.761|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders."||||=0.761
91526375|NCT01107743|182927940|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
91526376|NCT01107743|182927941|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.31|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.310
91526377|NCT01107743|182927942|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.251|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.251
91671624|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.962|STANDARD_ERROR_OF_MEAN|2.576||0.4474||95.0|-3.122|7.046|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.046|-3.122|0.4474
91526378|NCT01107743|182927943|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.756|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.756
91526379|NCT01107743|182927944|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.706|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.706
91671625|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.316|STANDARD_ERROR_OF_MEAN|2.59||0.0416||95.0|0.204|10.427|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.427|0.204|0.0416
91671626|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.372|STANDARD_ERROR_OF_MEAN|2.566||0.5935||95.0|-3.694|6.438|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||6.438|-3.694|0.5935
91671627|NCT00442546|183238168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.272|STANDARD_ERROR_OF_MEAN|2.674||0.3966||95.0|-3.006|7.551|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.551|-3.006|0.3966
91792818|NCT02751931|183463235|OTHER||Mean Difference (Net)|7.98||||0.617|TWO_SIDED|95.0|-24.0|40.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.0|-24.0|0.617
91526380|NCT01107743|182927945|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.192|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.192
91526381|NCT01107743|182927946|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders."||||=0.005
91526382|NCT01107743|182927947|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
91526383|NCT01107743|182927948|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.596|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.596
91526384|NCT01107743|182927949|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.252
91671628|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.729|STANDARD_ERROR_OF_MEAN|2.631||0.5117||95.0|-3.457|6.916|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||6.916|-3.457|0.5117
91671629|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.532|STANDARD_ERROR_OF_MEAN|2.675||0.0154||95.0|1.258|11.805|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||11.805|1.258|0.0154
91671630|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.901|STANDARD_ERROR_OF_MEAN|2.353||0.7022||95.0|-3.738|5.54|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||5.540|-3.738|0.7022
91671631|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.509|STANDARD_ERROR_OF_MEAN|2.343||0.0557||95.0|-0.11|9.129|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.129|-0.110|0.0557
91671632|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.171|STANDARD_ERROR_OF_MEAN|2.552||0.2161||95.0|-1.874|8.215|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.215|-1.874|0.2161
91671633|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.135|STANDARD_ERROR_OF_MEAN|2.548||0.0058||95.0|2.098|12.172|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||12.172|2.098|0.0058
91526385|NCT01107743|182927950|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=1.000
91671634|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.185|STANDARD_ERROR_OF_MEAN|3.993||0.1283||95.0|-1.853|14.223|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||14.223|-1.853|0.1283
91671635|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.173|STANDARD_ERROR_OF_MEAN|4.033||0.008||95.0|3.056|19.291|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||19.291|3.056|0.0080
91671636|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.941|STANDARD_ERROR_OF_MEAN|2.15||0.0018||95.0|7.414|18.468|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||18.468|7.414|0.0018
91792819|NCT02751931|183463235|OTHER||Mean Difference (Net)|39.52||||0.035|TWO_SIDED|95.0|3.0|76.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||76.0|3.0|0.035
91715472|NCT02858401|183321959|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91526386|NCT01107743|182927951|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.518|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.518
91526387|NCT01107743|182927952|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.645
91526388|NCT01107743|182927953|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.13|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders."||||=0.130
91526389|NCT01107743|182927954|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.185|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=0.185
91526390|NCT01107743|182927955|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.714|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.714
91526391|NCT01107743|182927956|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.835|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.835
91526392|NCT01107743|182927957|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.252
91526393|NCT02224482|182927958|SUPERIORITY|||||||0.9634|||||||Mixed Models Analysis|||||||.9634
91526394|NCT02224482|182927959|SUPERIORITY|||||||0.5214|||||||Mixed Models Analysis|||||||.5214
91526395|NCT02224482|182927960|SUPERIORITY|||||||0.4875|||||||Mixed Models Analysis|||||||.4875
91637263|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-3.43|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-10.81|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.96|-10.81|
91637264|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-5.38|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-12.64|1.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||1.89|-12.64|
91637265|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|95.0|-7.55|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||7.39|-7.55|
91637266|NCT03091920|183166566|OTHER|No statistical testing was performed.|Least squares mean difference|-1.89|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-8.89|5.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||5.12|-8.89|
91637267|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.17|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.59|-4.17|
91637268|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-1.09|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.47|2.29|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.29|-4.47|
91637269|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|95.0|-4.02|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.14|-4.02|
91637270|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-2.67|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-6.6|1.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.26|-6.60|
91637271|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-5.77|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.10|-5.77|
91526396|NCT02224482|182927961|SUPERIORITY|||||||0.7938|||||||Mixed Models Analysis|||||||.7938
91526397|NCT02224482|182927962|SUPERIORITY|||||||0.6765|||||||Mixed Models Analysis|||||||.6765
91526398|NCT02224482|182927963|SUPERIORITY|||||||0.7061|||||||Mixed Models Analysis|||||||.7061
91671637|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.941|STANDARD_ERROR_OF_MEAN|3.533||0.0038||95.0|8.859|27.023|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||27.023|8.859|0.0038
91671638|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.125|STANDARD_ERROR_OF_MEAN|2.115||0.5953||95.0|-3.045|5.296|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.296|-3.045|0.5953
91671639|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.331|STANDARD_ERROR_OF_MEAN|2.172||0.1267||95.0|-0.952|7.613|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||7.613|-0.952|0.1267
91671640|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.617|STANDARD_ERROR_OF_MEAN|2.339||0.2647||95.0|-1.997|7.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.231|-1.997|0.2647
91671641|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|2.421||0.0181||95.0|0.995|10.548|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.548|0.995|0.0181
91671642|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.374|STANDARD_ERROR_OF_MEAN|2.299||0.5507||95.0|-3.161|5.91|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||5.910|-3.161|0.5507
91671643|NCT00442546|183238169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|2.393||0.3164||95.0|-2.317|7.124|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.124|-2.317|0.3164
91671644|NCT00442546|183238170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4365||95.0|||||Log Rank|||||||0.4365
91671645|NCT00442546|183238170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||95.0|||||Log Rank|||||||0.4023
91671646|NCT00442546|183238171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024||95.0|||||Log Rank|||||||0.4024
91671647|NCT00442546|183238171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0|||||Log Rank|||||||0.1910
91671648|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.347|STANDARD_ERROR_OF_MEAN|2.497||0.3483||95.0|-2.573|7.268|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||7.268|-2.573|0.3483
91671649|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.155|STANDARD_ERROR_OF_MEAN|2.498||0.2078||95.0|-1.766|8.077|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.077|-1.766|0.2078
91671650|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.126|STANDARD_ERROR_OF_MEAN|6.436||0.4299||95.0|-7.836|18.088|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.088|-7.836|0.4299
91671651|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.146|STANDARD_ERROR_OF_MEAN|6.726||0.4482||95.0|-8.4|18.693|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.693|-8.400|0.4482
91671652|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.036|STANDARD_ERROR_OF_MEAN|4.426||0.6472||95.0|-6.818|10.89|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.890|-6.818|0.6472
91671653|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.156|STANDARD_ERROR_OF_MEAN|4.642||0.4992||95.0|-6.129|12.442|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.442|-6.129|0.4992
91671654|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.656|STANDARD_ERROR_OF_MEAN|5.149||0.6072||95.0|-7.578|12.891|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.891|-7.578|0.6072
91671655|NCT00442546|183238172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.963|STANDARD_ERROR_OF_MEAN|4.906||0.3146||95.0|-4.789|14.714|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.714|-4.789|0.3146
91671656|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.177|STANDARD_ERROR_OF_MEAN|2.326||0.0739||95.0|-0.407|8.76|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.760|-0.407|0.0739
91671657|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.176|STANDARD_ERROR_OF_MEAN|2.327||0.074||95.0|-0.409|8.761|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.761|-0.409|0.0740
91671658|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.298|STANDARD_ERROR_OF_MEAN|6.418||0.2615||95.0|-5.628|20.224|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||20.224|-5.628|0.2615
91671659|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.286|STANDARD_ERROR_OF_MEAN|6.707||0.6266||95.0|-10.22|16.795|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||16.795|-10.22|0.6266
91671660|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.17|STANDARD_ERROR_OF_MEAN|3.958||0.2963||95.0|-3.747|12.086|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.086|-3.747|0.2963
91671661|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.248|STANDARD_ERROR_OF_MEAN|4.151||0.1375||95.0|-2.054|14.55|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||14.550|-2.054|0.1375
91671662|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431|STANDARD_ERROR_OF_MEAN|4.895||0.2703||95.0|-4.298|15.161|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||15.161|-4.298|0.2703
91671663|NCT00442546|183238173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.663|STANDARD_ERROR_OF_MEAN|4.664||0.104||95.0|-1.607|16.933|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||16.933|-1.607|0.1040
91671664|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.579|STANDARD_ERROR_OF_MEAN|3.154||0.8545||95.0|-5.635|6.793|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||6.793|-5.635|0.8545
91671665|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|3.155||0.5006||95.0|-4.088|8.344|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.344|-4.088|0.5006
91671666|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|8.248||0.7217||95.0|-13.66|19.569|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||19.569|-13.66|0.7217
91671667|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.011|STANDARD_ERROR_OF_MEAN|8.62||0.4203||95.0|-10.35|24.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||24.372|-10.35|0.4203
91671668|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.6||0.9859||95.0|-11.3|11.102|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.102|-11.30|0.9859
91671669|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|5.873||0.9915||95.0|-11.68|11.811|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.811|-11.68|0.9915
91671670|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|6.508||0.9843||95.0|-13.06|12.808|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.808|-13.06|0.9843
91671671|NCT00442546|183238174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.351|STANDARD_ERROR_OF_MEAN|6.201||0.7055||95.0|-9.974|14.677|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.677|-9.974|0.7055
91671672|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.315||0.9405||95.0|-0.614|0.661|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.661|-0.614|0.9405
91671673|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.287||0.5641||95.0|-0.749|0.415|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.415|-0.749|0.5641
91671674|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
91671675|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
91671676|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.328|STANDARD_ERROR_OF_MEAN|0.882||0.1925||95.0|-3.596|0.94|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.940|-3.596|0.1925
91671677|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.982||0.9654||95.0|-2.568|2.479|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||2.479|-2.568|0.9654
91671678|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.352|STANDARD_ERROR_OF_MEAN|1.782||0.235||95.0|-6.712|2.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.008|-6.712|0.2350
91671679|NCT00442546|183238175|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.859||0.742||95.0|-1.806|2.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.399|-1.806|0.7420
91671680|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.329||0.5299||95.0|-0.458|0.874|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.874|-0.458|0.5299
91715473|NCT02858401|183321959|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91792820|NCT02751931|183463235|OTHER||Mean Difference (Net)|19.81||||0.167|TWO_SIDED|95.0|-8.7|48.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||48.3|-8.7|0.167
91671681|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.355|STANDARD_ERROR_OF_MEAN|0.3||0.2442||95.0|-0.964|0.253|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.253|-0.964|0.2442
91671682|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
91671683|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
91671684|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.024||0.324||95.0|-3.751|1.512|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.512|-3.751|0.3240
91671685|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|1.139||0.9503||95.0|-2.853|3.003|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||3.003|-2.853|0.9503
91671686|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.833|STANDARD_ERROR_OF_MEAN|1.858||0.3618||95.0|-6.379|2.712|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.712|-6.379|0.3618
91671687|NCT00442546|183238176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.896||0.7226||95.0|-1.859|2.525|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.525|-1.859|0.7226
91671688|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.2473
91671689|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0239||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.0239
91671690|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6118||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6118
91671691|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6730
91671692|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5954||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.5954
91671693|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7784||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.7784
91671694|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7293||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.7293
91671695|NCT00442546|183238177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5202||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.5202
91671696|NCT00442546|183238178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1509||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.1509
91671697|NCT00442546|183238178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3822||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.3822
91671698|NCT00442546|183238178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2825||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.2825
91671699|NCT00442546|183238178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7733||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.7733
91671700|NCT02449473|183238180|SUPERIORITY|The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.|Least square (LS) geometric mean ratio|1.43||||0.3862|TWO_SIDED|95.0|0.63|3.27|||ANCOVA|||Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.||3.27|0.63|0.3862
91715474|NCT02858401|183321960|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715475|NCT02858401|183321960|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
91715476|NCT02858401|183321960|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
91715477|NCT02858401|183321960|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715478|NCT02858401|183321960|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715479|NCT02858401|183321960|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715480|NCT02858401|183321961|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91792821|NCT02751931|183463235|OTHER||Mean Difference (Net)|75.25||||0.005|TWO_SIDED|95.0|25.8|124.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||124.7|25.8|0.005
91671701|NCT02449473|183238181|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.21||||0.0546|TWO_SIDED|95.0|1.0|1.48|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.||1.48|1.00|0.0546
91671702|NCT02449473|183238182|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.57||||0.6334|TWO_SIDED|95.0|0.06|6.0|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.||6.00|0.06|0.6334
91671703|NCT02449473|183238183|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.11||||0.3769|TWO_SIDED|95.0|0.88|1.4|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.40|0.88|0.3769
91671704|NCT02449473|183238184|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.49||||0.1126|TWO_SIDED|95.0|0.2|1.2|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.20|0.20|0.1126
91671705|NCT04039919|183238211|OTHER||Geometric LS Mean ratio|0.785|||||TWO_SIDED|90.0|0.6513|0.9461||||||The log-transformed PK parameters was analyzed by a mixed analysis of variance (ANOVA) with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9461|0.6513|
91671706|NCT04039919|183238212|OTHER||Geometric LS Mean Ratio|0.8342|||||TWO_SIDED|90.0|0.6999|0.9942||||||The log-transformed PK parameters was analyzed by a mixed ANOVA with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9942|0.6999|
91671707|NCT03460158|183238239|OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.1524||0.8822|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injection||||0.8822
91671708|NCT03460158|183238239|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1466||0.2223|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injection||||0.2223
91671709|NCT03460158|183238239|OTHER||Mean Difference (Final Values)|-0.369|STANDARD_ERROR_OF_MEAN|0.113||0.0015|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injection||||0.0015
91671710|NCT00263887|183238241|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|||The main effect ANCOVA model includes the change from baseline to endpoint as the dependent variable, treatment and center as fixed factors, change in logarithm of total lung volume and baseline measurement as covariates.||||0.049
91671711|NCT03095118|183238252|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Proteinuria baseline values compared to 6 month follow up values||||0.001
91671712|NCT03095118|183238253|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Proteinuria baseline values compared to 12 month follow up values||||0.004
91671713|NCT03095118|183238255|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Serum creatinine baseline values compared to 6 month follow up values||||0.15
91671714|NCT03095118|183238256|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Serum creatinine baseline values comparted to 12 month follow up values||||0.16
91671715|NCT03420768|183238280|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.13|17.7||||||||17.70|0.13|
91671716|NCT03420768|183238280|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.26|20.23||||||||20.23|0.26|
91671717|NCT02075606|183238287|OTHER||Odds Ratio (OR)|0.17|||=|0.126|TWO_SIDED|95.0|0.02|1.65|||Regression, Logistic|||Clinical symptomatic response as dependent variable and CTC presence at baseline as explanatory variable was used to perform the logistic regression analysis.||1.65|0.02|=0.126
91671718|NCT00983476|183238294|SUPERIORITY_OR_OTHER||Slope|2.2||||0.11|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).|Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.11
91671719|NCT00983476|183238295|SUPERIORITY_OR_OTHER||Slope|4.02||||0.02|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).|In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.02
91671720|NCT00983476|183238296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.32|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was not statistically significant.|||||0.32
91671721|NCT00983476|183238297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23||||0.11|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.11
91671722|NCT00983476|183238298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.47|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.47
91526399|NCT02224482|182927964|SUPERIORITY|||||||0.7593|||||||Mixed Models Analysis|||||||.7593
91715481|NCT02858401|183321961|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715482|NCT02858401|183321961|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715483|NCT02858401|183321962|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
91485437|NCT01325623|182844028|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.8537
91485438|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.2079|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.2079
91485439|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.6562|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.6562
91637272|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-2.25|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-5.83|1.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.32|-5.83|
91715484|NCT02858401|183321962|OTHER|||||||0.3755|||||||Wilcoxon rank sum test|||||||0.3755
91485440|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.9376|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.9376
91485441|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0100
91485442|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.8532|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.8532
91485443|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.4954|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.4954
91485444|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.1877|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.1877
91485445|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.4189
91485446|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.2365|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.2365
91485447|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.4138|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4138
91485448|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.8701|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.8701
91485449|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0527|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0527
91485450|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.1353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1353
91485451|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.6927|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.6927
91715485|NCT02858401|183321962|OTHER|||||||0.4577|||||||Wilcoxon rank sum test|||||||0.4577
91715486|NCT02858401|183321962|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
91715487|NCT02858401|183321962|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
91715488|NCT02858401|183321962|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
91715489|NCT02858401|183321963|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715490|NCT02858401|183321963|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
91715491|NCT02858401|183321963|OTHER|||||||0.7526|||||||Wilcoxon rank sum test|||||||0.7526
91715492|NCT02858401|183321964|OTHER|||||||0.5546|||||||Wilcoxon rank sum test|||||||0.5546
91715493|NCT02858401|183321964|OTHER|||||||0.6937|||||||Wilcoxon rank sum test|||||||0.6937
91715494|NCT02858401|183321964|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
91715495|NCT02858401|183321964|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715496|NCT02858401|183321964|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715497|NCT02858401|183321964|OTHER|||||||0.7878|||||||Wilcoxon rank sum test|||||||0.7878
91715498|NCT02858401|183321965|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715499|NCT02858401|183321965|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715500|NCT02858401|183321965|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715501|NCT02858401|183321966|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715502|NCT02858401|183321966|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715503|NCT02858401|183321966|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715504|NCT02858401|183321966|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715505|NCT02858401|183321966|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
91715506|NCT02858401|183321966|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
91715507|NCT02858401|183321967|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91715508|NCT02858401|183321967|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
91715509|NCT02858401|183321967|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
91715510|NCT02858401|183321967|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91671723|NCT00983476|183238299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.51|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.51
91671724|NCT00983476|183238300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.83|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.83
91671725|NCT01439724|183238306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.158||||0.05|TWO_SIDED|95.0|0.05|0.498|||Chi-squared|||The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.||0.498|0.050|0.05
91671726|NCT04019054|183238311|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group.||||||0.518|||||||ANOVA|||||||0.518
91671727|NCT04019054|183238312|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is within-group differences.||||||0.008||||||a priori threshold for significance of p=0.05. Observed power η2=0.39.|ANOVA|||||||0.008
91671728|NCT04019054|183238312|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is between-group differences.|||||>|0.05||||||a priori threshold for significance of p=0.05.|ANOVA|||||||>0.05
91671729|NCT04019054|183238313|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is within-group difference over time.||||||0.004||||||a priori threshold for significance p=0.05. Result above describes within group testing over time. Observed power η2=0.43.|ANOVA|||||||0.004
91792822|NCT02751931|183463235|OTHER||Mean Difference (Net)|34.01||||0.02|TWO_SIDED|95.0|5.7|62.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||62.3|5.7|0.020
91671730|NCT04019054|183238313|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is the between-group comparison|||||>|0.05||||||a priori threshold for significance p=0.05|ANOVA|||||||>0.05
91485452|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.4964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.4964
91671731|NCT04019054|183238314|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.01||||||Threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of skin conductance level (SCL) as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.01
91671732|NCT04019054|183238314|SUPERIORITY|||||||0.029||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||The second statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of skin conductance level (SCL) (as a function of step and timepoint).||||0.029
91671733|NCT04019054|183238315|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
91671734|NCT04019054|183238315|SUPERIORITY|||||||0.63||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and timepoint.||||0.63
91671735|NCT04019054|183238315|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
91671736|NCT04019054|183238315|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of group and timepoint.||||<0.001
91671737|NCT04019054|183238315|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
91671738|NCT04019054|183238315|SUPERIORITY|||||||0.047||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and group.||||0.047
91671739|NCT04019054|183238316|SUPERIORITY||Mann Whitney U statistic|13.5|STANDARD_ERROR_OF_MEAN|9.58||0.027|TWO_SIDED|||||a priori threshold for significance of p=0.05|Wilcoxon (Mann-Whitney)|||2-sided Mann-Whitney U Test (nonparametric) utilized to compare the ability of the groups to tolerate treatment intensity.||||0.027
91715511|NCT02858401|183321967|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91715512|NCT02858401|183321968|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715513|NCT02858401|183321968|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715514|NCT02858401|183321968|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715515|NCT02858401|183321969|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715516|NCT02858401|183321969|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
91637273|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-3.97|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-9.5|1.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.56|-9.50|
91637274|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.52|1.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.18|-9.52|
91637275|NCT03091920|183166567|OTHER|No statistical testing was performed.|Least squares mean difference|-4.07|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-9.01|0.87|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.87|-9.01|
91637276|NCT03091920|183166568|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|95.0|-8.01|1.21|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.21|-8.01|
91637277|NCT03091920|183166568|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-8.21|1.02|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.02|-8.21|
91637278|NCT03091920|183166568|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-7.53|0.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||0.92|-7.53|
91637279|NCT03091920|183166568|OTHER|No statistical testing was performed.|Least squares mean difference|-2.01|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-6.24|2.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.23|-6.24|
91671740|NCT04019054|183238318|OTHER|A pair of chi-square analyses were performed to validate blinding of the study (based on questionnaires completed by subjects and raters). Given the small sample size, Fisher's exact method was utilized. The number of correct and incorrect guesses for each group were examined once for the subject guesses and once for the rater's guesses.|||||>|0.05|||||||Fisher Exact|For the subjects, p=0.64 using Fisher's exact method. For the raters, p=1 using Fisher's exact method.||||||>.05
91671741|NCT04019054|183238319|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
91671742|NCT04019054|183238319|SUPERIORITY||||||>|0.05||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and timepoint.||||>.05
91671743|NCT04019054|183238319|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
91671744|NCT04019054|183238319|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of group and timepoint.||||<.001
91671745|NCT04019054|183238319|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
91671746|NCT04019054|183238319|SUPERIORITY|||||||0.024||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and group.||||0.024
91715517|NCT02858401|183321969|OTHER|||||||0.1784|||||||Wilcoxon rank sum test|||||||0.1784
91715518|NCT02858401|183321969|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715519|NCT02858401|183321969|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715520|NCT02858401|183321969|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
91715521|NCT02858401|183321970|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715522|NCT02858401|183321970|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715523|NCT02858401|183321970|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715524|NCT02858401|183321971|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715525|NCT02858401|183321971|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715526|NCT02858401|183321971|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715527|NCT02858401|183321972|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
91715528|NCT02858401|183321972|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
91715529|NCT02858401|183321973|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715530|NCT02858401|183321973|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715531|NCT02858401|183321973|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715532|NCT02858401|183321974|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
91715533|NCT02858401|183321974|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
91715534|NCT02858401|183321974|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
91485453|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0238|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0238
91637280|NCT03091920|183166568|OTHER|No statistical testing was performed.|Least squares mean difference|-7.29|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-12.8|-1.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.79|-12.80|
91637281|NCT03091920|183166568|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-10.43|0.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||0.23|-10.43|
91637282|NCT03091920|183166569|OTHER|No statistical testing was performed.|Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-2.97|4.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.95|-2.97|
91637283|NCT03091920|183166569|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.41|4.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.52|-3.41|
91637284|NCT03091920|183166569|OTHER|No statistical testing was performed.|Least squares mean difference|-2.54|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.63|2.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.56|-7.63|
91637285|NCT03091920|183166569|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.36|2.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.85|-7.36|
91637286|NCT03091920|183166569|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|3.13|||TWO_SIDED|95.0|-7.55|5.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.49|-7.55|
91637287|NCT03091920|183166569|OTHER|No statistical testing was performed.|Least squares mean difference|-3.68|STANDARD_ERROR_OF_MEAN|3.04|||TWO_SIDED|95.0|-10.0|2.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.65|-10.00|
91637288|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|2.49|||TWO_SIDED|95.0|-7.76|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.59|-7.76|
91637289|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-4.06|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-9.32|1.19|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.19|-9.32|
91637290|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-9.51|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.80|-9.51|
91671747|NCT01040793|183238320|SUPERIORITY_OR_OTHER||Ratio to placebo|1.118|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|1.043|1.199|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.199|1.043|0.0018
91637291|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-10.4|0.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.93|-10.40|
91637292|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-12.06|1.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||1.86|-12.06|
91637293|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-2.96|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-9.87|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||3.96|-9.87|
91637294|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|-4.7|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.45|-4.70|
91637295|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|2.63|||TWO_SIDED|95.0|-4.9|6.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.01|-4.90|
91637296|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-7.22|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.10|-7.22|
91637297|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-7.27|6.34|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.34|-7.27|
91671748|NCT01040793|183238320|SUPERIORITY_OR_OTHER||Ratio to placebo|1.105|STANDARD_ERROR_OF_MEAN|0.039||0.0052||95.0|1.03|1.184|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.184|1.030|0.0052
91671749|NCT01040793|183238321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.035||0.0155||95.0|0.016|0.152|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.152|0.016|0.0155
91715535|NCT02858401|183321975|OTHER|||||||0.8504|||||||Wilcoxon rank sum test|||||||0.8504
91637298|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-3.26|6.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.69|-3.26|
91637299|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-4.69|5.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.20|-4.69|
91637300|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|95.0|-8.5|-0.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.36|-8.50|
91637301|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|95.0|-8.3|-0.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.03|-8.30|
91671750|NCT01040793|183238321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.098|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.234|0.098|<0.0001
91671751|NCT01040793|183238322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|STANDARD_ERROR_OF_MEAN|0.214||0.1176||95.0|-0.757|0.085|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.085|-0.757|0.1176
91671752|NCT01040793|183238322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.214||0.7591||95.0|-0.486|0.355|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.355|-0.486|0.7591
91671753|NCT01040793|183238323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.094|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.234|0.094|<0.0001
91637302|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.82|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.04|-9.82|
91671754|NCT01040793|183238323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.125|0.265|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.265|0.125|<0.0001
91637303|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-7.51|5.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||5.38|-7.51|
91637304|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-2.82|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-8.12|2.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||2.48|-8.12|
91637305|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|-6.63|3.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||3.91|-6.63|
91637306|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.19|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-7.35|4.97|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.97|-7.35|
91671755|NCT01040793|183238324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.034||0.0245||95.0|0.01|0.146|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.146|0.010|0.0245
91671756|NCT01040793|183238324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.105|0.24|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.240|0.105|<0.0001
91671757|NCT01040793|183238325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.07||0.2897||95.0|-0.211|0.063|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.063|-0.211|0.2897
91671758|NCT01040793|183238325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.069||0.7199||95.0|-0.162|0.112|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.112|-0.162|0.7199
91671759|NCT01040793|183238326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.146||0.5313||95.0|-0.196|0.379|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.379|-0.196|0.5313
91715536|NCT02858401|183321975|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
91715537|NCT02858401|183321975|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
91671760|NCT01040793|183238326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|STANDARD_ERROR_OF_MEAN|0.146||0.0198||95.0|0.055|0.628|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.628|0.055|0.0198
91671761|NCT01040793|183238327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.053||0.1048||95.0|-0.19|0.018|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.018|-0.190|0.1048
91671762|NCT01040793|183238327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.053||0.0246||95.0|-0.224|-0.015|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.015|-0.224|0.0246
91715538|NCT02858401|183321975|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91671763|NCT01040793|183238328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.318|-0.108|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.108|-0.318|<0.0001
91671764|NCT01040793|183238328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.187|STANDARD_ERROR_OF_MEAN|0.054||0.0005||95.0|-0.293|-0.082|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.082|-0.293|0.0005
91671765|NCT01040793|183238329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.071|0.228|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.228|0.071|0.0002
91671766|NCT01040793|183238329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.04||0.0001||95.0|0.076|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.233|0.076|0.0001
91671767|NCT01040793|183238330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.162|0.303|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.303|0.162|<0.0001
91671768|NCT01040793|183238330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.133|0.273|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.273|0.133|<0.0001
91671769|NCT01040793|183238331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.056||0.3109||95.0|-0.053|0.166|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.166|-0.053|0.3109
91671770|NCT01040793|183238331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.056||0.608||95.0|-0.081|0.138|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.138|-0.081|0.6080
91671771|NCT01040793|183238332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.056||0.6809||95.0|-0.087|0.133|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.133|-0.087|0.6809
91671772|NCT01040793|183238332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.858||95.0|-0.1|0.12|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.120|-0.100|0.8580
91671773|NCT01040793|183238333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.148|0.073|<0.0001
91671774|NCT01040793|183238333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.148|0.073|<0.0001
91671775|NCT01040793|183238334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.151|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.233|0.151|<0.0001
91671776|NCT01040793|183238334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.153|0.236|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.236|0.153|<0.0001
91671777|NCT01040793|183238335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.036||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.191|0.047|0.0013
91671778|NCT01040793|183238335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.191|0.047|0.0013
91671779|NCT01040793|183238336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.196|0.333|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.333|0.196|<0.0001
91671780|NCT01040793|183238336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.350|0.212|<0.0001
91671781|NCT01040793|183238337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.156|0.405|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.405|0.156|<0.0001
91671782|NCT01040793|183238337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.166|0.416|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.416|0.166|<0.0001
91671783|NCT01040793|183238338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.441|0.719|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.719|0.441|<0.0001
91671784|NCT01040793|183238338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.552|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001||95.0|0.412|0.691|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.691|0.412|<0.0001
91715539|NCT02858401|183321975|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
91671785|NCT05070390|183238344|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.62|2.44|||||GMR and 90% confidence interval (CI) were estimated using a linear mixed effects model and referencing a t-distribution.|||2.44|0.62|
91637307|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.26|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-7.3|4.77|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.77|-7.30|
91637308|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-5.86|STANDARD_ERROR_OF_MEAN|3.29|||TWO_SIDED|95.0|-12.68|0.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.95|-12.68|
91637309|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-13.16|0.76|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.76|-13.16|
91637310|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-7.87|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.65|-7.87|
91637311|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-0.63|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.85|5.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||5.59|-6.85|
91637312|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-6.91|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-12.74|-1.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-1.08|-12.74|
91637313|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-9.73|1.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||1.66|-9.73|
91637314|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-8.25|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-13.59|-2.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-2.91|-13.59|
91637315|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-5.56|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-10.76|-0.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-0.35|-10.76|
91637316|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-7.07|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-15.2|1.05|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.05|-15.20|
91637317|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-5.85|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-13.68|1.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.98|-13.68|
91637318|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-10.14|7.33|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.33|-10.14|
91485454|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0139
91637319|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-5.16|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|-13.46|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.14|-13.46|
91637320|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-2.37|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.14|5.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||5.40|-10.14|
91637321|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-4.51|STANDARD_ERROR_OF_MEAN|3.72|||TWO_SIDED|95.0|-12.25|3.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.23|-12.25|
91671786|NCT05070390|183238345|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.63|||||TWO_SIDED|90.0|0.55|4.83|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||4.83|0.55|
91671787|NCT05070390|183238346|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.45|||||TWO_SIDED|90.0|0.7|2.99|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||2.99|0.70|
91671788|NCT05070390|183238349|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.41|1.62|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.62|0.41|
91637322|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-0.44|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.6|6.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||6.72|-7.60|
91637323|NCT03091920|183166570|OTHER|No statistical testing was performed.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-8.88|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.92|-8.88|
91637324|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|3.19|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-0.1|6.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.48|-0.10|
91637325|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|3.53|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.25|6.82|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.82|0.25|
91715540|NCT02858401|183321976|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91671789|NCT05070390|183238350|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.92|||||TWO_SIDED|90.0|0.6|1.42|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.42|0.60|
91671790|NCT05070390|183238353|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
91715541|NCT02858401|183321976|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715542|NCT02858401|183321976|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91637326|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.4|6.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||6.32|0.40|
91637327|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|4.59|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|95.0|0.95|8.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.23|0.95|
91637328|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|4.49|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|0.86|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.12|0.86|
91637329|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|4.54|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|1.27|7.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.81|1.27|
91637330|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|-1.45|6.61|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.61|-1.45|
91637331|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|3.17|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-0.78|7.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.11|-0.78|
91637332|NCT03091920|183166571|OTHER|No statistical testing was performed.|Least squares mean difference|2.87|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-0.71|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.45|-0.71|
91637333|NCT03091920|183166572|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.65|6.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.99|-2.65|
91637334|NCT03091920|183166572|OTHER|No statistical testing was performed.|Least squares mean difference|4.09|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-0.73|8.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||8.91|-0.73|
91637335|NCT03091920|183166572|OTHER|No statistical testing was performed.|Least squares mean difference|4.56|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.6|8.51|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.51|0.60|
91637336|NCT03091920|183166572|OTHER|No statistical testing was performed.|Least squares mean difference|4.02|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.07|7.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||7.98|0.07|
91637337|NCT03091920|183166572|OTHER|No statistical testing was performed.|Least squares mean difference|3.12|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-1.15|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.39|-1.15|
91637338|NCT03091920|183166572|OTHER|No statistical testing was performed.|Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-0.44|7.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.92|-0.44|
91637339|NCT03091920|183166573|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.1|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||7.49|1.10|
91637340|NCT03091920|183166573|OTHER|No statistical testing was performed.|Least squares mean difference|2.94|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.23|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.10|-0.23|
91637341|NCT03091920|183166573|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|0.5|9.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.11|0.50|
91637342|NCT03091920|183166573|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|0.84|9.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.36|0.84|
91637343|NCT03091920|183166573|OTHER|No statistical testing was performed.|Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.93|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.70|-2.93|
91637344|NCT03091920|183166573|OTHER|No statistical testing was performed.|Least squares mean difference|2.55|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.15|7.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.25|-2.15|
91637345|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|6.81|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|1.4|12.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||12.22|1.40|
91715543|NCT02858401|183321977|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715544|NCT02858401|183321977|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715545|NCT02858401|183321977|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715546|NCT02858401|183321978|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
91715547|NCT02858401|183321978|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
91715548|NCT02858401|183321979|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715549|NCT02858401|183321979|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715550|NCT02858401|183321979|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91637346|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|1.12|11.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||11.99|1.12|
91637347|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|-0.95|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-8.18|6.28|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||6.28|-8.18|
91637348|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|1.85|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-5.39|9.09|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||9.09|-5.39|
91637349|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.98|5.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||5.23|-5.98|
91637350|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-2.5|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||8.70|-2.50|
91637351|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|6.46|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|95.0|2.02|10.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.89|2.02|
91637352|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.57|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|1.19|9.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||9.95|1.19|
91637353|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|3.63|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|0.34|6.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.91|0.34|
91637354|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|2.41|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-0.84|5.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.66|-0.84|
91637355|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|1.74|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-2.89|6.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.36|-2.89|
91715551|NCT02858401|183321980|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715552|NCT02858401|183321980|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715553|NCT02858401|183321980|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
91715554|NCT02858401|183321981|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
91715555|NCT02858401|183321981|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
91715556|NCT02858401|183321981|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
91715557|NCT02858401|183321982|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715558|NCT02858401|183321982|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715559|NCT02858401|183321982|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
91715560|NCT02858401|183321983|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715561|NCT02858401|183321983|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
91715562|NCT02858401|183321983|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
91715563|NCT02858401|183321984|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
91715564|NCT02858401|183321984|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
91715565|NCT02858401|183321984|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
91715566|NCT02858401|183321987|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715567|NCT02858401|183321987|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715568|NCT02858401|183321987|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715569|NCT02858401|183321987|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715570|NCT02858401|183321987|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715571|NCT02858401|183321987|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715572|NCT02858401|183321988|OTHER|||||||0.3333|||||||Fisher Exact|||||||0.3333
91715573|NCT02858401|183321989|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715574|NCT02858401|183321989|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715575|NCT02858401|183321989|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715576|NCT02858401|183321989|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715577|NCT02858401|183321989|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715578|NCT02858401|183321989|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715579|NCT02858401|183321990|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715580|NCT02858401|183321990|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715581|NCT02858401|183321990|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715582|NCT02858401|183321990|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715583|NCT02858401|183321990|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715584|NCT02858401|183321990|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715585|NCT02858401|183321991|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91637356|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|95.0|-4.33|4.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.99|-4.33|
91671791|NCT05070390|183238354|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
91671792|NCT05070390|183238355|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.38|||||TWO_SIDED|90.0|0.13|1.13|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.13|0.13|
91671793|NCT02412722|183238364|SUPERIORITY||Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.46|0.76||||||||0.76|0.46|
91671794|NCT02412722|183238365|SUPERIORITY||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.59|1.36||||||||1.36|0.59|
91671795|NCT02412722|183238366|SUPERIORITY||Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.72|1.49||||||||1.49|0.72|
91671796|NCT02412722|183238370|SUPERIORITY||Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.78|1.47||||||||1.47|0.78|
91637357|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-1.17|9.88|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||9.88|-1.17|
91637358|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.41|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|95.0|-0.14|10.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||10.96|-0.14|
91637359|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.88|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|0.36|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||9.40|0.36|
91671797|NCT02412722|183238371|SUPERIORITY||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.75|1.68||||||||1.68|0.75|
91671798|NCT02412722|183238372|SUPERIORITY||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.26||||||||1.26|0.67|
91671799|NCT03877926|183238383|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 2 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|0.93|
91671800|NCT03877926|183238383|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.05|||||TWO_SIDED|95.0|0.96|1.14||||||||1.14|0.96|
91671801|NCT03877926|183238383|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 2 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.04|||||TWO_SIDED|95.0|0.95|1.13||||||||1.13|0.95|
91485455|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.2822|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2822
91485456|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.1363|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.1363
91671802|NCT03877926|183238385|OTHER||Percentage of participants|66.3|||||TWO_SIDED|95.0|64.5|68.1||||||||68.1|64.5|
91671803|NCT03877926|183238386|NON_INFERIORITY|A non-inferiority margin of -15% was used for the difference in percentage of AV7909 participants (pooled from three AV7909 study groups \[Lot 1, 2, and 3\]) vs. BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. The success criterion was defined as the lower bound of 95% confidence interval of the difference in the percentage of AV7909 vs. BioThrax participants being greater than -15%.|Difference in percentage|24.5|||||TWO_SIDED|95.0|20.0|29.2||||||||29.2|20.0|
91671804|NCT03877926|183238387|OTHER|Relative risk of serious adverse events incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|2.5|||||TWO_SIDED|95.0|0.9|6.5|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||6.5|0.9|
91671805|NCT03877926|183238388|OTHER|Success criteria was defined as the lower bound for the 95% CI for the proportion of participants pooled from all three AV7909 study groups with TNA NF50 ≥0.15 to be ≥67%.|Percentage of participants|97.8|||||TWO_SIDED|95.0|97.2|98.3||||||||98.3|97.2|
91671806|NCT03877926|183238390|OTHER|Relative risk of adverse events of special interest (events of autoimmune etiology) incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|1.3|||||TWO_SIDED|95.0|0.3|5.0|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||5.0|0.3|
91671807|NCT00588731|183238400|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.90
91671808|NCT00588731|183238401|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
91671809|NCT00346164|183238406|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
91671810|NCT00346164|183238407|OTHER|||||||0.0049|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0049
91671811|NCT00346164|183238408|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
91715586|NCT02858401|183321991|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715587|NCT02858401|183321991|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715588|NCT02858401|183321992|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91637360|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-0.22|8.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||8.83|-0.22|
91637361|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.04|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-0.65|8.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||8.72|-0.65|
91637362|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|2.26|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.42|6.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||6.94|-2.42|
91637363|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|6.9|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|1.91|11.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.89|1.91|
91637364|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|6.15|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|1.22|11.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.08|1.22|
91637365|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|0.05|9.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||9.93|0.05|
91637366|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.45|10.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||10.22|0.45|
91637367|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|1.67|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-3.17|6.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.52|-3.17|
91637368|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.03|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-0.86|8.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||8.92|-0.86|
91637369|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-1.18|9.27|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||9.27|-1.18|
91637370|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-1.38|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||8.90|-1.38|
91637371|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.18|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-1.7|12.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.06|-1.70|
91671812|NCT00346164|183238409|OTHER|||||||0.0096|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.||||0.0096
91671813|NCT00346164|183238410|OTHER||||||<|0.0001|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
91715589|NCT02858401|183321992|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91637372|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.61|STANDARD_ERROR_OF_MEAN|3.25|||TWO_SIDED|95.0|-1.14|12.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.37|-1.14|
91637373|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|-0.21|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-5.35|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||4.92|-5.35|
91637374|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.42|6.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||6.65|-3.42|
91715590|NCT02858401|183321992|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715591|NCT02858401|183321994|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91637375|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.08|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-1.19|11.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.36|-1.19|
91637376|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-0.83|11.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.42|-0.83|
91637377|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-4.02|6.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||6.63|-4.02|
91671814|NCT00346164|183238411|OTHER|||||||0.0228|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0228
91671815|NCT00346164|183238413|OTHER||Kappa statistic|0.82|||||TWO_SIDED|95.0|0.76|0.88||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.88|0.76|
91671816|NCT00346164|183238414|OTHER||Kappa statistic|0.42|||||TWO_SIDED|95.0|0.36|0.48||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.48|0.36|
91671817|NCT01684878|183238417|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.88||||0.4983|TWO_SIDED|95.0|0.62|1.27|||2 sided log-rank|||The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan vs paclitaxel), previous anti-angiogenic therapy (yes versus no), and progression-free interval (PFI) since platinum therapy (\< 3 months versus 3-6 months). A hazard ratio \< 1 favored the pertuzumab + chemotherapy treatment arm.||1.27|0.62|0.4983
91671818|NCT01684878|183238419|SUPERIORITY_OR_OTHER||Difference in response rate|6.06||||0.4102|TWO_SIDED|95.0|6.0|18.3|||Fisher Exact||Approximate 95% CI for difference of 2 rates using Hauck-Anderson method.|||18.3|6.0|0.4102
91671819|NCT01684878|183238424|SUPERIORITY_OR_OTHER||Hazard ratio (stratified)|0.9||||0.596|TWO_SIDED|95.0|0.61|1.32|||2 sided log-rank||A hazard ratio \< 1 favored the Pertuzumab + Chemotherapy treatment group|The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan versus paclitaxel), previous angiogenic therapy (yes versus no) and PFI since platinum therapy (\<3 months versus 3-6 months).||1.32|0.61|0.5960
91671820|NCT00810888|183238425|SUPERIORITY|||||||1||||||not adjusted for multiple comparisons as a prior hypothesis critical value \<0.05|Fisher Exact|||Fisher's exact test||||1.00
91671821|NCT00810888|183238426|SUPERIORITY|||||||0.66|||||||Fisher Exact|||Only the randomized subjects will be compared||||0.66
91671822|NCT00810888|183238427|SUPERIORITY||Sensitivity|38.5||||0.004|TWO_SIDED|95.0|17.6|64.6|||Fisher Exact|||||64.6|17.6|0.004
91671823|NCT00810888|183238428|SUPERIORITY||Specificity|94.2||||0.004|TWO_SIDED|95.0|85.6|98.1|||Fisher Exact|||||98.1|85.6|0.004
91792823|NCT02751931|183463235|OTHER||Mean Difference (Net)|44.43||||0.033|TWO_SIDED|95.0|3.9|84.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||84.9|3.9|0.033
91671824|NCT00810888|183238429|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
91671825|NCT00810888|183238430|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
91671826|NCT00810888|183238431|OTHER|A Kappa test of overall agreement was used|Kappa|0.77|||||TWO_SIDED|95.0|0.61|0.93|||||A kappa of \>0.75 is considered excellent agreement|||0.93|0.61|
91671827|NCT00810888|183238432|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||Groups 1 and 2 only the spot positive subjects randomized to interventional drug or placebo||||0.25
91671828|NCT01955044|183238447|SUPERIORITY||Median Difference (Final Values)|1.23||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||DHA levels||||0.05
91671829|NCT01886937|183238493|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
91671830|NCT00605917|183238496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders."||||<0.001
91671831|NCT00605917|183238497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.002
91671832|NCT00605917|183238498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders."||||0.032
91671833|NCT00605917|183238499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders."||||<0.001
91671834|NCT00605917|183238500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
91671835|NCT00605917|183238501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders."||||0.001
91671836|NCT00605917|183238502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders."||||0.028
91671837|NCT00605917|183238503|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
91671838|NCT00605917|183238504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|Chi-squared|not adjusted, p=0.050||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||0.030
91715592|NCT02858401|183321994|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91715593|NCT02858401|183321994|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91637378|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|2.93|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-2.26|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||8.12|-2.26|
91637379|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|-1.34|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-7.52|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.85|-7.52|
91637380|NCT03091920|183166574|OTHER|No statistical testing was performed.|Least squares mean difference|-1.14|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.25|4.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.98|-7.25|
91637381|NCT03091920|183166575|OTHER|No statistical testing was performed.|Least squares mean difference|-0.288|STANDARD_ERROR_OF_MEAN|0.274|||TWO_SIDED|95.0|-0.857|0.282|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.282|-0.857|
91637382|NCT03091920|183166575|OTHER|No statistical testing was performed.|Least squares mean difference|-0.105|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.708|0.498|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.498|-0.708|
91637383|NCT03091920|183166575|OTHER|No statistical testing was performed.|Least squares mean difference|-0.196|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|-0.727|0.335|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.335|-0.727|
91671839|NCT00605917|183238505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.013
91671840|NCT00605917|183238506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.004
91671841|NCT00605917|183238507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders."||||0.004
91671842|NCT01506908|183238508|SUPERIORITY_OR_OTHER||Least squares means difference|-15.9|||<|0.0001|TWO_SIDED|95.0|-21.6|-10.2|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes||-10.2|-21.6|<0.0001
91671843|NCT01506908|183238509|SUPERIORITY_OR_OTHER||Least squares means difference|-4.2||||0.0511|TWO_SIDED|95.0|-8.4|0.0|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.||0.0|-8.4|0.0511
91671844|NCT01506908|183238510|SUPERIORITY_OR_OTHER||Least squares means difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.7|-6.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.||-6.4|-16.7|<0.0001
91671845|NCT01506908|183238511|SUPERIORITY_OR_OTHER||Least squares means difference|-17.8|||<|0.0001|TWO_SIDED|95.0|-23.8|-11.7|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.||-11.7|-23.8|<0.0001
91671846|NCT01506908|183238512|SUPERIORITY_OR_OTHER||Least square mean difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-24.4|-11.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.||-11.4|-24.4|<0.0001
91671847|NCT00925301|183238519|SUPERIORITY||Difference|12.5||||0.2996|TWO_SIDED|95.0|-13.4|37.3|||Cochran-Mantel-Haenszel|p-value from Cochran-Mantel-Haenszel test stratified by sex|The difference between the percentage of successes between migalastat and placebo treatment groups|||37.3|-13.4|0.2996
91671848|NCT00925301|183238522|OTHER|Mixed effects model for repeated measures (MMRM) approach with fixed effects of treatment, time (Month 6 and Month 12), mutation type (amenable or non-amenable), time by treatment interaction, time by mutation type interaction, and the baseline value as a covariate. An unstructured covariance matrix to account for repeated measures within a participant was assumed.||||||0.014||||||Significant at the 0.050 level|MMRM|||||||0.014
91671849|NCT00925301|183238523|OTHER||Difference LSMeans|-0.3||||0.0078|TWO_SIDED|95.0|-0.6|-0.1||Significant at the 0.010 level|ANCOVA|||The change from Baseline in the average number of kidney ICs was analyzed using an ANCOVA model with covariate adjustment for the baseline value and factors for treatment group and the treatment by baseline interaction.||-0.1|-0.6|0.0078
91792824|NCT02751931|183463235|OTHER||Mean Difference (Net)|8.68||||0.503|TWO_SIDED|95.0|-17.3|34.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0|t-test, 2 sided|||Change From Baseline at Week 12 - Children||34.7|-17.3|0.503
91637384|NCT03091920|183166580|OTHER|No statistical testing was performed.|Least squares mean difference|-23.188|STANDARD_ERROR_OF_MEAN|27.97|||TWO_SIDED|95.0|-84.13|37.753|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||37.753|-84.130|
91637385|NCT03091920|183166580|OTHER|No statistical testing was performed.|Least squares mean difference|-14.033|STANDARD_ERROR_OF_MEAN|26.092|||TWO_SIDED|95.0|-70.883|42.817|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||42.817|-70.883|
91637386|NCT03091920|183166580|OTHER|No statistical testing was performed.|Least squares mean difference|-18.611|STANDARD_ERROR_OF_MEAN|24.138|||TWO_SIDED|95.0|-71.204|33.982|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||33.982|-71.204|
91637387|NCT03091920|183166580|OTHER|No statistical testing was performed.|Least squares mean difference|-25.389|STANDARD_ERROR_OF_MEAN|16.885|||TWO_SIDED|95.0|-62.551|11.774|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||11.774|-62.551|
91637388|NCT03091920|183166580|OTHER|No statistical testing was performed.|Least squares mean difference|-21.176|STANDARD_ERROR_OF_MEAN|16.221|||TWO_SIDED|95.0|-56.879|14.527|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||14.527|-56.879|
91637389|NCT03091920|183166580|OTHER|No statistical testing was performed.|Least squares mean difference|-23.282|STANDARD_ERROR_OF_MEAN|14.691|||TWO_SIDED|95.0|-55.618|9.053|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||9.053|-55.618|
91637390|NCT00346775|183166601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.517|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||||0.3|-0.6|0.517
91637391|NCT02138227|183166604|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91637392|NCT02138227|183166605|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|F (2, 1574)||||||<0.01
91637393|NCT00965458|183166896|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.065
91637394|NCT00965458|183166897|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.019
91637395|NCT00965458|183166897|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.002
91637396|NCT00965458|183166898|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.065
91637397|NCT00965458|183166898|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.015
91671850|NCT00292227|183238533|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.75||||||90.0|-2.63|1.12|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.12|-2.63|
91671851|NCT00292227|183238534|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.01||||||90.0|-2.21|2.19|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.19|-2.21|
91637398|NCT00965458|183166899|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean insulin use comparison||||0.020
91637399|NCT00965458|183166899|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean insulin use comparison||||0.002
91637400|NCT00965458|183166900|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Baseline to Week 52||||<0.001
91637401|NCT00965458|183166900|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Week 52 to Week 104||||<0.001
91637402|NCT00965458|183166901|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean HbA1C comparison||||0.746
91637403|NCT00965458|183166901|SUPERIORITY_OR_OTHER|||||||0.942|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean HbA1C comparison||||0.942
91715594|NCT01418339|183322003|SUPERIORITY||Treatment Difference|-4.63|||=|0.0028|TWO_SIDED|95.0|-7.62|-1.63||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-1.63|-7.62|=0.0028
91671852|NCT00292227|183238535|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.84||||||90.0|-1.12|2.8|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.80|-1.12|
91671853|NCT00292227|183238536|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.26||||||90.0|-1.8|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.80|
91671854|NCT00292227|183238537|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.11||||||90.0|-2.25|2.02|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.02|-2.25|
91671855|NCT00292227|183238538|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.07||||||90.0|-2.14|2.28|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.28|-2.14|
91715595|NCT01418339|183322004|SUPERIORITY||Treatment Difference|-0.52|||=|0.0124|TWO_SIDED|95.0|-0.93|-0.12||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-0.12|-0.93|=0.0124
91715596|NCT01418339|183322005|SUPERIORITY||Treatment Difference|-2.0|||=|0.5317|TWO_SIDED|95.0|-8.31|4.32||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||4.32|-8.31|=0.5317
91671856|NCT00292227|183238539|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.56||||||90.0|-2.84|1.72|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.72|-2.84|
91671857|NCT00292227|183238540|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.26||||||90.0|-2.29|1.78|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.78|-2.29|
91715597|NCT02219685|183322006|SUPERIORITY_OR_OTHER|||||||0.58||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.58
91715598|NCT02219685|183322006|SUPERIORITY_OR_OTHER|||||||0.48||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.48
91715599|NCT02219685|183322006|SUPERIORITY_OR_OTHER|||||||0.96||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.96
91715600|NCT02219685|183322007|SUPERIORITY_OR_OTHER|||||||0.54||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.54
91715601|NCT02219685|183322007|SUPERIORITY_OR_OTHER|||||||0.57||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.57
91715602|NCT02219685|183322007|SUPERIORITY_OR_OTHER|||||||0.63||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.63
91637404|NCT01545375|183166905|SUPERIORITY|The objective was to demonstrate that VE induced by GSK2189242A vaccine (three doses in the first year of life and a booster dose in the second year of life)in preventing clinical AOM diagnosed and verified against AAP criteria was greater than 0%, as compared to the control group. One-sided p-value for the Wald-Test obtained from the general Cox proportional hazard model was calculated.|Vaccine Efficacy|3.81||||0.3016|TWO_SIDED|95.0|-11.35|16.9||The primary objective was met if the one-sided p-value calculated for the null hypothesis H0=\[clinical AOM VE ≤ 0%\] was lower than defined 1-sided alpha level: (17.8%).|Regression, Cox|||VE-AOM against AAP criteria: Occurrence of AOM during efficacy follow-up period was compared between groups to estimate Vaccine Efficacy (VE) and its 95% confidence interval using the Anderson \& Gill model (generalization of Cox proportional hazard model) taking into account for recurrent events \[Kelly, 2000\]. VE= (1 - hazard ratio) x 100 Censoring occurred at the time of the last scheduled or medically attended visit.||16.90|-11.35|0.3016
91637405|NCT04516291|183166979|OTHER||Least Square (LS) Mean difference|-22.4|STANDARD_ERROR_OF_MEAN|4.93|<|0.001|TWO_SIDED|95.0|-32.1|-12.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.7|-32.1|<0.001
91637406|NCT04516291|183166979|OTHER||LS Mean difference|-22.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|-31.7|-12.4|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.4|-31.7|<0.001
91671858|NCT00292227|183238541|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.17||||||90.0|-3.25|0.91|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.91|-3.25|
91671859|NCT00292227|183238542|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.69||||||90.0|-0.34|3.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.73|-0.34|
91671860|NCT00292227|183238543|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.31||||||90.0|-1.7|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.70|
91671861|NCT00292227|183238544|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.65||||||90.0|-0.65|3.96|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.96|-0.65|
91671862|NCT00292227|183238545|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.21||||||90.0|-1.78|1.36|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.36|-1.78|
91671863|NCT00292227|183238546|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.53||||||90.0|-2.37|1.3|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.30|-2.37|
91715603|NCT02219685|183322008|SUPERIORITY_OR_OTHER|||||||0.7||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.70
91715604|NCT02219685|183322008|SUPERIORITY_OR_OTHER|||||||0.21||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.21
91637407|NCT04516291|183166979|OTHER||LS Mean difference|-24.1|STANDARD_ERROR_OF_MEAN|5.05|<|0.001|TWO_SIDED|95.0|-34.1|-14.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-14.2|-34.1|<0.001
91671864|NCT00292227|183238547|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.41||||||90.0|-2.3|1.49|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.49|-2.30|
91637408|NCT04516291|183166979|OTHER||LS Mean difference|-27.7|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-35.7|-19.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-19.6|-35.7|<0.001
91637409|NCT04516291|183166979|OTHER||LS Mean difference|-26.6|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-34.5|-18.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-18.8|-34.5|<0.001
91671865|NCT00292227|183238548|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.5||||||90.0|-2.34|1.35|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.35|-2.34|
91671866|NCT00292227|183238549|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.21||||||90.0|-1.76|2.17|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.17|-1.76|
91671867|NCT00292227|183238550|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.23||||||90.0|-2.99|0.53|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.53|-2.99|
91671868|NCT00292227|183238551|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.62||||||90.0|-3.87|0.63|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.63|-3.87|
91671869|NCT00292227|183238552|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.81||||||90.0|-2.55|0.93|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.93|-2.55|
91671870|NCT00292227|183238553|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.37||||||90.0|-2.13|1.39|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.39|-2.13|
91671871|NCT00292227|183238554|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.68||||||90.0|-2.6|1.25|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.25|-2.60|
91715605|NCT02219685|183322008|SUPERIORITY_OR_OTHER|||||||0.59||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.59
91715606|NCT02219685|183322009|SUPERIORITY_OR_OTHER|||||||0.0795||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.0795
91671872|NCT00292227|183238555|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.17||||||90.0|-0.69|3.03|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.03|-0.69|
91671873|NCT00292227|183238556|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.8||||||90.0|-1.14|2.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.73|-1.14|
91671874|NCT00292227|183238557|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.42||||||90.0|-2.33|1.5|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.50|-2.33|
91671875|NCT00292227|183238558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||||95.0|-1.04|1.71|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.71|-1.04|
91671876|NCT00292227|183238559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||||95.0|-0.72|1.68|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.68|-0.72|
91671877|NCT00292227|183238560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.51||||||95.0|0.3|2.73|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||2.73|0.30|
91671878|NCT00292227|183238561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.5||||||95.0|11.78|15.22|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||15.22|11.78|
91671879|NCT00292227|183238562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.02||||||95.0|9.12|12.93|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.93|9.12|
91671880|NCT00292227|183238563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.3||||||95.0|9.94|12.67|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.67|9.94|
91671881|NCT00292227|183238564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.28||||||95.0|6.85|9.7|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.70|6.85|
91485457|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0019
91715607|NCT02219685|183322010|SUPERIORITY_OR_OTHER|||||||0.7007||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.7007
91715608|NCT02219685|183322011|SUPERIORITY_OR_OTHER|||||||0.2677||||||The p-value was ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.2677
91715609|NCT02219685|183322012|SUPERIORITY_OR_OTHER|||||||0.987||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.9870
91485458|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.1293|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1293
91485459|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.5252|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.5252
91485460|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0642|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0642
91637410|NCT04516291|183166979|OTHER||LS Mean difference|-24.7|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-32.5|-16.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-16.9|-32.5|<0.001
91637411|NCT04516291|183166979|OTHER||LS Mean difference|-26.5|STANDARD_ERROR_OF_MEAN|4.51|<|0.001|TWO_SIDED|95.0|-35.4|-17.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-17.6|-35.4|<0.001
91637412|NCT04516291|183166981|OTHER||LS Mean difference|-44.0|STANDARD_ERROR_OF_MEAN|6.66|<|0.001|TWO_SIDED|95.0|-57.1|-30.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.8|-57.1|<0.001
91637413|NCT04516291|183166981|OTHER||LS Mean difference|-43.8|STANDARD_ERROR_OF_MEAN|6.64|<|0.001|TWO_SIDED|95.0|-56.9|-30.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.7|-56.9|<0.001
91637414|NCT04516291|183166981|OTHER||LS Mean difference|-41.3|STANDARD_ERROR_OF_MEAN|6.85|<|0.001|TWO_SIDED|95.0|-54.8|-27.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-27.8|-54.8|<0.001
91637415|NCT04516291|183166981|OTHER||LS Mean difference|-50.5|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-61.4|-39.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-39.6|-61.4|<0.001
91637416|NCT04516291|183166981|OTHER||LS Mean difference|-45.9|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-56.5|-35.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-35.2|-56.5|<0.001
91637417|NCT04516291|183166981|OTHER||LS Mean difference|-50.7|STANDARD_ERROR_OF_MEAN|5.35|<|0.001|TWO_SIDED|95.0|-61.2|-40.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-40.1|-61.2|<0.001
91637418|NCT04516291|183166981|OTHER||LS Mean difference|-56.8|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-68.9|-44.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-44.7|-68.9|<0.001
91637419|NCT04516291|183166981|OTHER||LS Mean difference|-15.1|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-23.7|-6.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-6.5|-23.7|<0.001
91637420|NCT04516291|183166981|OTHER||LS Mean difference|-10.6|STANDARD_ERROR_OF_MEAN|4.34||0.015|TWO_SIDED|95.0|-19.2|-2.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.1|-19.2|0.015
91637421|NCT04516291|183166981|OTHER||LS Mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.49||0.011|TWO_SIDED|95.0|-20.3|-2.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.7|-20.3|0.011
91637422|NCT04516291|183166981|OTHER||LS Mean difference|-12.5|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-19.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.3|-19.7|<0.001
91637423|NCT04516291|183166981|OTHER||LS Mean difference|-12.6|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-19.5|-5.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.6|-19.5|<0.001
91715610|NCT02219685|183322013|SUPERIORITY_OR_OTHER|||||||0.3388||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.3388
91715611|NCT01746862|183322078|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.47|||<|0.0001|TWO_SIDED|95.0|2.17|4.78|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with baseline age and baseline height as the covariates.||||4.78|2.17|<0.0001
91637424|NCT04516291|183166981|OTHER||LS Mean difference|-6.0|STANDARD_ERROR_OF_MEAN|3.56||0.095|TWO_SIDED|95.0|-13.0|1.0|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||1.0|-13.0|0.095
91715612|NCT04585919|183322124|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.005
91715613|NCT04585919|183322125|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.19
91715614|NCT03519009|183322129|SUPERIORITY||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|1.8|6.3|||longitudinal logistic regression|||||6.3|1.8|<0.001
91715615|NCT03519009|183322130|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.5|4.4|||longitudinal logistic regression|||||4.4|1.5|<0.001
91671882|NCT00292227|183238565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||||95.0|7.57|11.02|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||11.02|7.57|
91671883|NCT00292227|183238566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.87||||||95.0|7.47|10.28|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||10.28|7.47|
91671884|NCT00292227|183238567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.6||||||95.0|7.25|9.96|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.96|7.25|
91485461|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0025
91637425|NCT04516291|183166981|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.01||0.036|TWO_SIDED|95.0|-16.4|-0.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-0.6|-16.4|0.036
91637426|NCT04516291|183166981|OTHER||LS Mean difference|-10.0|STANDARD_ERROR_OF_MEAN|6.55||0.129|TWO_SIDED|95.0|-22.9|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-22.9|0.129
91637427|NCT04516291|183166981|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|6.65||0.238|TWO_SIDED|95.0|-21.0|5.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||5.2|-21.0|0.238
91637428|NCT04516291|183166981|OTHER||LS Mean difference|-11.4|STANDARD_ERROR_OF_MEAN|6.73||0.09|TWO_SIDED|95.0|-24.7|1.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||1.8|-24.7|0.090
91637429|NCT04516291|183166981|OTHER||LS Mean difference|-16.0|STANDARD_ERROR_OF_MEAN|5.44||0.004|TWO_SIDED|95.0|-26.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-5.3|-26.7|0.004
91637430|NCT04516291|183166981|OTHER||LS Mean difference|-14.5|STANDARD_ERROR_OF_MEAN|5.38||0.008|TWO_SIDED|95.0|-25.1|-3.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-3.9|-25.1|0.008
91637431|NCT04516291|183166981|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|5.28||0.136|TWO_SIDED|95.0|-18.3|2.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.5|-18.3|0.136
91637432|NCT04516291|183166981|OTHER||LS Mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.01||0.138|TWO_SIDED|95.0|-20.8|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-20.8|0.138
91637433|NCT04516291|183166983|OTHER||LS Mean difference|-69.9|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|95.0|-81.6|-58.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-58.1|-81.6|<0.001
91637434|NCT04516291|183166983|OTHER||LS Mean difference|-79.6|STANDARD_ERROR_OF_MEAN|6.03|<|0.001|TWO_SIDED|95.0|-91.5|-67.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-67.7|-91.5|<0.001
91637435|NCT04516291|183166983|OTHER||LS Mean difference|-77.1|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-89.4|-64.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-64.9|-89.4|<0.001
91637436|NCT04516291|183166983|OTHER||LS Mean difference|-86.3|STANDARD_ERROR_OF_MEAN|5.04|<|0.001|TWO_SIDED|95.0|-96.2|-76.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-76.3|-96.2|<0.001
91637437|NCT04516291|183166983|OTHER||LS Mean difference|-80.4|STANDARD_ERROR_OF_MEAN|4.82|<|0.001|TWO_SIDED|95.0|-89.9|-70.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-70.9|-89.9|<0.001
91637438|NCT04516291|183166983|OTHER||LS Mean difference|-92.2|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-101.9|-82.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-82.6|-101.9|<0.001
91715616|NCT05209880|183322133|SUPERIORITY|||||||0.5835|||||||Wilcoxon (Mann-Whitney)|||||||0.5835
91715617|NCT03834493|183322143|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6621|TWO_SIDED|95.0|0.88|1.22|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.22|0.88|0.6621
91715618|NCT03834493|183322144|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4073|TWO_SIDED|95.0|0.84|1.14|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.14|0.84|0.4073
91715619|NCT03834493|183322145|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.83|
91715620|NCT03834493|183322146|OTHER||Difference in Percentage|3.4|||||TWO_SIDED|95.0|-1.5|8.3|||||Stratified Miettinen and Nurminen method|||8.3|-1.5|
91715621|NCT03834493|183322147|OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-3.4|4.1|||||Stratified Miettinen and Nurminen method|||4.1|-3.4|
91715622|NCT03834493|183322148|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-0.2|6.1|||||Stratified Miettinen and Nurminen method|||6.1|-0.2|
91715623|NCT03834493|183322150|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Stratified Cox model with Efron's tie handling method|||1.15|0.86|
91715624|NCT03834493|183322151|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.74|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.74|
91715625|NCT03834493|183322152|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.82|1.35|||||Stratified Cox model with Efron's tie handling method|||1.35|0.82|
91715626|NCT03834493|183322153|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.85|1.51|||||Stratified Cox model with Efron's tie handling method|||1.51|0.85|
91715627|NCT04817332|183322198|SUPERIORITY||Odds Ratio (OR)|0.72||||0.008|TWO_SIDED|95.0|0.57|0.92|||Odds ratio Ordinal Logistic Regression|adjusted for the stratifying factors of age as a fixed effect and site using robust standard errors to account for clustering||||0.92|0.57|0.008
91637439|NCT04516291|183166983|OTHER||LS Mean difference|-95.2|STANDARD_ERROR_OF_MEAN|5.59|<|0.001|TWO_SIDED|95.0|-106.2|-84.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-84.2|-106.2|<0.001
91715628|NCT04817332|183322199|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.058|TWO_SIDED|95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.058
91715629|NCT04817332|183322202|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||||1.13|0.84|
91715630|NCT04817332|183322204|SUPERIORITY||Rate ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
91715631|NCT04817332|183322205|SUPERIORITY||Rate ratio|1.13|||||TWO_SIDED|95.0|0.73|1.74||||||||1.74|0.73|
91715632|NCT04817332|183322206|SUPERIORITY||Rate ratio|0.84|||||TWO_SIDED|95.0|0.69|1.04||||||||1.04|0.69|
91715633|NCT04817332|183322207|SUPERIORITY||Rate ratio|1.68|||||TWO_SIDED|95.0|1.09|2.58||||||||2.58|1.09|
91715634|NCT04817332|183322208|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||||1.15|0.92|
91715635|NCT04817332|183322209|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|1.06|1.88||||||||1.88|1.06|
91715636|NCT04817332|183322223|SUPERIORITY||Mean Difference (Final Values)|-67.0|||||TWO_SIDED|95.0|-102.0|-31.0||||||||-31|-102|
91637440|NCT02181634|183166993|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.099|TWO_SIDED|95.0|0.86|4.75|||Log Rank|||||4.75|0.86|0.099
91637441|NCT02181634|183166994|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.34|TWO_SIDED|95.0|0.64|3.71|||Log Rank|||||3.71|0.64|0.34
91637442|NCT04250558|183167002|OTHER|||||||0.05|||||||Regression, Logistic|||Kinetic parameters were assessed by Mann-Whitney U test in MATLAB Statistics and Machine Learning Toolbox. Receiver operating characteristic (ROC) analysis based on logistic regression was utilized, with one surgical condition versus the other two states as the binary dependent variable, and each perfusion-related kinetic parameter of Imax, IS and BF as the independent variable. Power analysis was performed to evaluate the statistical validity, using G\*Power software||||0.05
91637443|NCT02843282|183167042|SUPERIORITY||Mean Difference (Net)|0.69||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.040
91637444|NCT02843282|183167043|SUPERIORITY||Mean Difference (Net)|0.98||||0.004|TWO_SIDED||||||Regression, Linear|||||||0.004
91637445|NCT02843282|183167044|SUPERIORITY||Mean Difference (Net)|1.95|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
91637446|NCT02843282|183167045|SUPERIORITY||Mean Difference (Net)|0.52||||0.039|TWO_SIDED||||||Regression, Linear|||||||0.039
91637447|NCT02843282|183167046|SUPERIORITY||Mean Difference (Net)|0.42||||0.092|TWO_SIDED||||||Regression, Linear|||||||0.092
91637448|NCT02843282|183167047|SUPERIORITY||Mean Difference (Net)|6.58||||0.052|TWO_SIDED||||||Regression, Linear|||||||0.052
91637449|NCT02843282|183167048|SUPERIORITY||Mean Difference (Net)|0.52||||0.121|TWO_SIDED||||||Regression, Linear|||||||0.121
91637450|NCT02843282|183167049|SUPERIORITY||Mean Difference (Net)|1.23||||0.019|TWO_SIDED||||||Regression, Linear|||||||0.019
91637451|NCT02843282|183167050|SUPERIORITY||Mean Difference (Net)|0.37||||0.278|TWO_SIDED||||||Regression, Linear|||||||0.278
91637452|NCT02843282|183167051|SUPERIORITY||Mean Difference (Net)|7.0||||0.095|TWO_SIDED||||||Regression, Linear|||||||0.095
91637453|NCT02843282|183167052|OTHER||Mean Difference (Net)|0.15|||<|0.01|TWO_SIDED||||||Whole brain voxel-wise correlation analy|||||||< 0.01
91637454|NCT02843282|183167053|SUPERIORITY||Mean Difference (Net)|1.22||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
91637455|NCT02843282|183167054|SUPERIORITY||Mean Difference (Net)|1.33||||0.007|TWO_SIDED||||||Regression, Linear|||||||0.007
91637456|NCT01091116|183167060|SUPERIORITY_OR_OTHER|||||||0.5263||95.0|||||ANCOVA|||Tests of Fixed Effects for the primary efficacy variable including baseline treatment and visit (from Visit 3 to Visit 5) as covariates||||0.5263
91637457|NCT02155660|183167076|SUPERIORITY||Rate ratio|0.85||||0.0638|TWO_SIDED|95.0|0.71|1.01|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.01|0.71|0.0638
91637458|NCT02155660|183167076|SUPERIORITY||Rate ratio|1.04||||0.6575|TWO_SIDED|95.0|0.88|1.23|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.23|0.88|0.6575
91637459|NCT02155660|183167076|SUPERIORITY||Rate ratio|0.93||||0.3988|TWO_SIDED|95.0|0.78|1.1|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.10|0.78|0.3988
91637460|NCT02155660|183167077|SUPERIORITY||Rate ratio|1.04||||0.7564|TWO_SIDED|95.0|0.82|1.32|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.32|0.82|0.7564
91637461|NCT02155660|183167077|SUPERIORITY||Rate ratio|1.08||||0.5573|TWO_SIDED|95.0|0.84|1.37|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.37|0.84|0.5573
91637462|NCT02155660|183167077|SUPERIORITY||Rate ratio|1.02||||0.8644|TWO_SIDED|95.0|0.8|1.3|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.30|0.80|0.8644
91637463|NCT02155660|183167078|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.5043|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.059|-0.029|0.5043
91637464|NCT02155660|183167078|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.7691|TWO_SIDED|95.0|-0.051|0.037|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.037|-0.051|0.7691
91637465|NCT02155660|183167078|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.3767|TWO_SIDED|95.0|-0.024|0.064|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.064|-0.024|0.3767
91637466|NCT02155660|183167079|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.3636|TWO_SIDED|95.0|-3.192|1.171|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.171|-3.192|0.3636
91637467|NCT02155660|183167079|SUPERIORITY||Mean Difference (Final Values)|-1.388||||0.2106|TWO_SIDED|95.0|-3.562|0.786|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.786|-3.562|0.2106
91637468|NCT02155660|183167079|SUPERIORITY||Mean Difference (Final Values)|-0.602||||0.5851|TWO_SIDED|95.0|-2.763|1.56|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.560|-2.763|0.5851
91637469|NCT02155660|183167080|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.8525|TWO_SIDED|95.0|-0.82|0.99|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.99|-0.82|0.8525
91637470|NCT02155660|183167080|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.987|TWO_SIDED|95.0|-0.91|0.89|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.89|-0.91|0.9870
91637471|NCT02155660|183167080|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8204|TWO_SIDED|95.0|-1.0|0.79|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.79|-1.00|0.8204
91637472|NCT02155660|183167081|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2636|TWO_SIDED|95.0|-1.102|0.301|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.301|-1.102|0.2636
91637473|NCT02155660|183167081|SUPERIORITY||Mean Difference (Final Values)|-0.296||||0.4087|TWO_SIDED|95.0|-0.998|0.406|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.406|-0.998|0.4087
91637474|NCT02155660|183167081|SUPERIORITY||Mean Difference (Final Values)|-0.425||||0.2336|TWO_SIDED|95.0|-1.125|0.275|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.275|-1.125|0.2336
91637475|NCT02155660|183167082|SUPERIORITY||Mean Difference (Final Values)|-0.642||||0.0012|TWO_SIDED|95.0|-1.029|-0.254|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.254|-1.029|0.0012
91637476|NCT02155660|183167082|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0852|TWO_SIDED|95.0|-0.727|0.047|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.047|-0.727|0.0852
91637477|NCT02155660|183167082|SUPERIORITY||Mean Difference (Final Values)|-0.364||||0.065|TWO_SIDED|95.0|-0.75|0.023|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.023|-0.750|0.0650
91637478|NCT02155660|183167083|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0415|TWO_SIDED|95.0|-0.081|-0.002|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.002|-0.081|0.0415
91671885|NCT00292227|183238568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.52||||||95.0|6.31|8.72|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.72|6.31|
91715637|NCT04817332|183322227|SUPERIORITY||Mean Difference (Final Values)|0.003|||||TWO_SIDED|95.0|-0.06|0.066||||||||0.066|-0.06|
91485462|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0024
91637479|NCT02155660|183167083|SUPERIORITY||Mean Difference (Final Values)|-0.055||||0.0069|TWO_SIDED|95.0|-0.094|-0.015|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.015|-0.094|0.0069
91637480|NCT02155660|183167083|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.2008|TWO_SIDED|95.0|-0.065|0.014|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.014|-0.065|0.2008
91637481|NCT02155660|183167087|SUPERIORITY||Rate ratio|0.98||||0.8158|TWO_SIDED|95.0|0.81|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.81|0.8158
91637482|NCT02155660|183167087|SUPERIORITY||Rate ratio|0.98||||0.8378|TWO_SIDED|95.0|0.82|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.82|0.8378
91637483|NCT02155660|183167087|SUPERIORITY||Rate ratio|0.92||||0.3759|TWO_SIDED|95.0|0.76|1.11|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.11|0.76|0.3759
91671886|NCT00292227|183238569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.58||||||95.0|6.21|8.95|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.95|6.21|
91792825|NCT02751931|183463235|OTHER||Mean Difference (Net)|38.23||||0.016|TWO_SIDED|95.0|7.8|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|7.8|0.016
91671887|NCT00292227|183238570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.19||||||95.0|4.94|7.45|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||7.45|4.94|
91671888|NCT00948792|183238594|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.8
91671889|NCT00948792|183238595|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.26
91671890|NCT00948792|183238596|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.09
91792826|NCT02751931|183463235|OTHER||Mean Difference (Net)|40.76||||0.043|TWO_SIDED|95.0|1.4|80.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||80.2|1.4|0.043
91637484|NCT02155660|183167088|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9141|TWO_SIDED|95.0|0.76|1.36|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.36|0.76|0.9141
91637485|NCT02155660|183167088|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0323|TWO_SIDED|95.0|1.03|1.87|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.87|1.03|0.0323
91637486|NCT02155660|183167088|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5109|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.48|0.82|0.5109
91671891|NCT03234608|183238597|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.56|TWO_SIDED|95.0|-0.44|0.81||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.81|-0.44|0.56
91671892|NCT03234608|183238598|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.79||0.73|TWO_SIDED|95.0|-1.28|1.84||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.84|-1.28|0.73
91671893|NCT03234608|183238599|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.17||0.94|TWO_SIDED|95.0|-0.35|0.33||The threshold for statistical significance was p\<0.05.|Regression, Linear|||Statistical analysis for Individual Level Healthcare Self-Efficacy Sub-scale.||0.33|-0.35|0.94
91671894|NCT03234608|183238599|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.65|TWO_SIDED|95.0|-0.33|0.52|||Regression, Linear|||Statistical analysis for Relationship-Dependent Healthcare Self-Efficacy Sub-scale||0.52|-0.33|0.65
91671895|NCT03234608|183238600|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.52||0.66|TWO_SIDED|95.0|-1.25|0.79||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.79|-1.25|0.66
91671896|NCT03234608|183238601|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.78||0.85|TWO_SIDED|95.0|-1.4|1.69||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.69|-1.40|0.85
91671897|NCT02105701|183238605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
91671898|NCT02105701|183238605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
91671899|NCT02105701|183238605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
91671900|NCT02105701|183238605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
91671901|NCT02105701|183238608|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
91671902|NCT02105701|183238608|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
91671903|NCT02105701|183238608|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
91671904|NCT02105701|183238608|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
91792827|NCT02751931|183463235|OTHER||Mean Difference (Net)|86.66|||<|0.001|TWO_SIDED|95.0|41.5|131.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||131.8|41.5|<0.001
91671905|NCT01362296|183238615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5197|TWO_SIDED|95.0|0.75|1.75||P-value from the stratified log-rank was adjusted for gender (male versus female).|Log Rank||HRs were estimated using a Pike estimator. The HR from the stratified log-rank test was adjusted for gender (male versus female).|||1.75|0.75|0.5197
91671906|NCT02339090|183238639|NON_INFERIORITY|Threshold for significance: annualized height velocity between somavaratan and daily rhGH ≤ -2.0 cm/year|LS Mean Difference|-1.28|||||TWO_SIDED|95.0|-2.32|-0.24||||||An ANCOVA model will be used to determine the adjusted (least squares) means and standard error (SE) to determine the confidence interval (CI) of the difference. ANCOVA model included treatment group, region, and gender as fixed effects; with baseline age and baseline IGF-I SDS as covariates.||-0.24|-2.32|
91671907|NCT04052698|183238666|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1645|||<|0.0001|TWO_SIDED|95.0|0.10194|0.26558|||Regression, Linear|||||0.26558|0.10194|<0.0001
91671908|NCT04052698|183238668|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1389|||<|0.0001|TWO_SIDED|95.0|0.07664|0.25187|||Regression, Linear|||||0.25187|0.07664|<0.0001
91671909|NCT06442410|183238680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671910|NCT06442410|183238681|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671911|NCT06442410|183238682|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91715638|NCT01435759|183322235|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.16|STANDARD_ERROR_OF_MEAN|1.01||0.004|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.|||||0.004
91637487|NCT02155660|183167090|SUPERIORITY||Rate ratio|0.68||||0.0287|TWO_SIDED|95.0|0.49|0.96|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.96|0.49|0.0287
91637488|NCT02155660|183167090|SUPERIORITY||Rate ratio|0.89||||0.4631|TWO_SIDED|95.0|0.65|1.22|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.22|0.65|0.4631
91671912|NCT06442410|183238683|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671913|NCT06442410|183238684|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671914|NCT06442410|183238685|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91715639|NCT01435759|183322235|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.5|STANDARD_ERROR_OF_MEAN|1.01||0.032|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.032
91485463|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.4464|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4464
91637489|NCT02155660|183167090|SUPERIORITY||Rate ratio|0.67||||0.0185|TWO_SIDED|95.0|0.48|0.94|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.94|0.48|0.0185
91671915|NCT06442410|183238687|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671916|NCT06442410|183238688|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91715640|NCT01435759|183322235|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.28|STANDARD_ERROR_OF_MEAN|1.01||0.003|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
91671917|NCT06442410|183238689|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671918|NCT06442410|183238690|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671919|NCT06442410|183238691|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671920|NCT06442410|183238692|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671921|NCT06442410|183238693|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91671922|NCT04947150|183238713|SUPERIORITY|||||||0.255||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA were used.||||||.255
91671923|NCT04947150|183238714|SUPERIORITY|||||||0.56||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.560
91671924|NCT04947150|183238715|SUPERIORITY|||||||0.319||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.319
91671925|NCT04947150|183238716|SUPERIORITY|||||||0.032||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.032
91671926|NCT04947150|183238717|SUPERIORITY|||||||0.044||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.044
91671927|NCT04947150|183238718|SUPERIORITY|||||||0.01||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated Measures ANOVA||||||.010
91671928|NCT04947150|183238719|SUPERIORITY|||||||0.073||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.073
91671929|NCT04947150|183238720|SUPERIORITY|||||||0.872||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.872
91637490|NCT02087085|183167102|SUPERIORITY||Least Squares Mean Difference|-0.3589|STANDARD_ERROR_OF_MEAN|0.1804||0.047|TWO_SIDED|95.0|-0.7132|-0.0047||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||-0.0047|-0.7132|0.047
91637491|NCT02087085|183167103|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.4||0.39|TWO_SIDED|95.0|-3.9|1.5||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.5|-3.9|0.390
91671930|NCT04947150|183238721|SUPERIORITY|||||||0.145||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated Measures ANOVA||||||.145
91671931|NCT04947150|183238722|SUPERIORITY|||||||0.173||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.173
91671932|NCT04947150|183238723|SUPERIORITY|||||||0.012||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.012
91671933|NCT04947150|183238724|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.008
91671934|NCT04947150|183238725|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671935|NCT04947150|183238726|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671936|NCT04947150|183238727|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671937|NCT04947150|183238728|SUPERIORITY|||||||0.382||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.382
91671938|NCT04947150|183238729|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||<.001
91637492|NCT02087085|183167104|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.301|TWO_SIDED|95.0|-4.2|1.3||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.3|-4.2|0.301
91671939|NCT04947150|183238730|SUPERIORITY|||||||0.178||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.178
91671940|NCT04947150|183238731|SUPERIORITY|||||||0.081||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.081
91671941|NCT04947150|183238732|SUPERIORITY|||||||0.343||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.343
91671942|NCT04947150|183238733|SUPERIORITY|||||||0.369||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.369
91792828|NCT02751931|183463235|OTHER||Mean Difference (Net)|31.08||||0.203|TWO_SIDED|95.0|-17.5|79.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||79.6|-17.5|0.203
91485464|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0511
91485465|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0002
91671943|NCT04947150|183238734|SUPERIORITY|||||||0.055||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.055
91671944|NCT04947150|183238737|SUPERIORITY|||||||0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.001
91671945|NCT04947150|183238738|SUPERIORITY|||||||0.079||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.079
91671946|NCT04947150|183238739|SUPERIORITY|||||||0.581||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.581
91671947|NCT04947150|183238740|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671948|NCT04947150|183238741|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671949|NCT04947150|183238742|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671950|NCT04947150|183238743|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671951|NCT04947150|183238747|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired Sample T-test||||||<.05
91671952|NCT04947150|183238749|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|Paired samples t-test||||||.006
91671953|NCT04947150|183238750|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired samples t-test||||||<.001
91671954|NCT04947150|183238751|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|Paired samples t-test||||||.220
91671955|NCT04947150|183238752|SUPERIORITY|||||||0.623|||||||t-test, 2 sided|Paired samples t-test||||||.623
91671956|NCT04947150|183238753|SUPERIORITY|||||||0.577||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.577
91671957|NCT04947150|183238754|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671958|NCT04947150|183238755|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
91671959|NCT04947150|183238756|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.008
91671960|NCT04947150|183238757|SUPERIORITY|||||||0.601||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.601
91671961|NCT04947150|183238758|SUPERIORITY|||||||0.088||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.088
91671962|NCT04947150|183238759|SUPERIORITY|||||||0.21||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.210
91671963|NCT04947150|183238760|SUPERIORITY|||||||0.06||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.060
91671964|NCT04947150|183238761|SUPERIORITY|||||||0.37||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.370
91485466|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0296|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.0296
91637493|NCT01425268|183167132|NON_INFERIORITY|Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.|margin of non-inferiority|-7.3|||||ONE_SIDED|95.0|-7.3241||||||The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of \> -10%.|The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).|||-7.3241|
91637494|NCT01425268|183167133|SUPERIORITY||||||<|0.0001|||||||Kaplan-Meier Log Rank test|Subjects not completing tissue expansion are censored in the analysis||||||<0.0001
91637495|NCT02681094|183167139|SUPERIORITY||LS mean difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||Mixed Models Analysis|||||-0.24|-0.55|<0.0001
91637496|NCT02681094|183167139|SUPERIORITY||LS mean difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.19|||Mixed Models Analysis|||||-0.19|-0.50|<0.0001
91637497|NCT02681094|183167140|SUPERIORITY||Risk Difference (RD)|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|26.9|||Method of Zhang, Tsiatis, and Davidian|||||26.9|12.7|<0.0001
91637498|NCT02681094|183167140|SUPERIORITY||Risk Difference (RD)|11.7||||0.0018|TWO_SIDED|95.0|4.4|19.1|||Method of Zhang, Tsiatis, and Davidian|||||19.1|4.4|0.0018
91637499|NCT02681094|183167141|SUPERIORITY||LS mean difference|-7.58||||0.0135|TWO_SIDED|95.0|-13.59|-1.57|||Mixed Models Analysis|||||-1.57|-13.59|0.0135
91637500|NCT02681094|183167141|SUPERIORITY||LS mean difference|-14.88|||<|0.0001|TWO_SIDED|95.0|-20.85|-8.91|||Mixed Models Analysis|||||-8.91|-20.85|<0.0001
91637501|NCT02681094|183167142|SUPERIORITY||LS mean difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.11|-1.09|||Mixed Models Analysis|||||-1.09|-2.11|<0.0001
91637502|NCT01072175|183167143|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.79|1.34|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.|||1.34|0.79|
91671965|NCT04947150|183238762|SUPERIORITY|||||||0.556||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.556
91671966|NCT04947150|183238763|SUPERIORITY|||||||0.913||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.913
91671967|NCT04947150|183238764|SUPERIORITY|||||||0.241||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.241
91715641|NCT01435759|183322235|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.91|STANDARD_ERROR_OF_MEAN|1.01||0.01|TWO_SIDED||||||MCP-Mod Analysis Method|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.010
91792829|NCT02751931|183463235|OTHER||Mean Difference (Net)|68.47||||0.019|TWO_SIDED|95.0|12.7|124.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||124.2|12.7|0.019
91637503|NCT01072175|183167143|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.78|1.25|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.78|
91637504|NCT01072175|183167143|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.27|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.|||1.27|0.84|
91637505|NCT01072175|183167143|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.66|1.45|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.|||1.45|0.66|
91671968|NCT02953678|183238765|OTHER||Exact method for binomial distributions|54.9|||||TWO_SIDED|95.0|42.7|66.8||||||||66.8|42.7|
91671969|NCT03535857|183238776|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.546|TWO_SIDED|95.0|||||Pairwise t- test|||||||0.546
91671970|NCT00546910|183238788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.001|TWO_SIDED|95.0|0.52|0.87||P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.87|0.52|<0.001
91671971|NCT00546910|183238788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.98|1.57||P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.57|0.98|<0.001
91671972|NCT00546910|183238788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.81|1.35||P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.81|<0.001
91671973|NCT00546910|183238788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.78|1.22||P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.22|0.78|<0.001
91671974|NCT00546910|183238788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.58|0.18|<0.001
91671975|NCT00546910|183238789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.6|||<|0.001|TWO_SIDED|95.0|8.2|14.99||P-value for ADHD-RS Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||14.99|8.20|<0.001
91671976|NCT00546910|183238790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED|95.0|0.76|1.46||P-value for CGI-S ADHD score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||1.46|0.76|<0.001
91671977|NCT00546910|183238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.74|||<|0.001|TWO_SIDED|95.0|3.55|7.92||P-value for Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||7.92|3.55|<0.001
91671978|NCT00546910|183238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.001|TWO_SIDED|95.0|2.49|5.44||P-value for Evening subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||5.44|2.49|0.001
91671979|NCT00546910|183238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||<|0.002|TWO_SIDED|95.0|0.42|1.93||P-value for Morning subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.93|0.42|<0.002
91671980|NCT00546910|183238791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.31|0.93||P-value for Item 11 (difficulty falling asleep).|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.31|<0.001
91671981|NCT00546910|183238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.66|1.35||P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.66|<0.001
91671982|NCT00546910|183238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.93||P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.46|<0.001
91671983|NCT00546910|183238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||<|0.001|TWO_SIDED|95.0|0.17|0.65||P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.65|0.17|<0.001
91671984|NCT00546910|183238792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.26|0.73||P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.73|0.26|<0.001
91671985|NCT00546910|183238793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.31|0.68||P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.68|0.31|<0.001
91671986|NCT00546910|183238793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.022|TWO_SIDED|95.0|0.02|0.31||P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.31|0.02|0.022
91671987|NCT00546910|183238794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.001|TWO_SIDED|95.0|0.69|1.18||P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.18|0.69|<0.001
91671988|NCT00546910|183238794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.178|TWO_SIDED|95.0|0.05|0.28||P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.28|0.05|0.178
91671989|NCT01011556|183238821|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.17|||<|0.001|TWO_SIDED|90.0|-8.489|-5.851|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-5.851|-8.489|<0.001
91671990|NCT01011556|183238821|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.48|||<|0.001|TWO_SIDED|90.0|-8.822|-6.144|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-6.144|-8.822|<0.001
91671991|NCT01011556|183238821|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-6.17|||<|0.001|TWO_SIDED|90.0|-7.448|-4.891|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-4.891|-7.448|<0.001
91671992|NCT01011556|183238822|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.58|||<|0.001|TWO_SIDED|90.0|-5.716|-3.452|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-3.452|-5.716|<0.001
91671993|NCT01011556|183238822|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.87|||<|0.001|TWO_SIDED|90.0|-5.006|-2.727|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.727|-5.006|<0.001
91637506|NCT01072175|183167144|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.85|1.19|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.19|0.85|
91637507|NCT01072175|183167144|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.82|1.08|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.08|0.82|
91637508|NCT01072175|183167144|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.84|1.25|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.84|
91637509|NCT01072175|183167144|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.81|1.03|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for GSK2285403 were calculated.|||1.03|0.81|
91637510|NCT01072175|183167144|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.81|1.29|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2298683 were calculated.|||1.29|0.81|
91637511|NCT01072175|183167144|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.76|1.37|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2167542 were calculated.|||1.37|0.76|
91637512|NCT01072175|183167151|SUPERIORITY_OR_OTHER||Unconditional exact method|-4.0|||||TWO_SIDED|95.0|-23.1|15.9||||||Difference in response rate Arm2 - Arm1||15.9|-23.1|
91637513|NCT01072175|183167151|SUPERIORITY_OR_OTHER||Unconditional exact method|22.0|||||TWO_SIDED|95.0|2.5|40.7||||||Difference in response rate Arm3 - Arm1||40.7|2.5|
91637514|NCT01072175|183167152|SUPERIORITY_OR_OTHER||Unconditional exact method|-6.0|||||TWO_SIDED|95.0|-24.9|14.1||||||Difference in response rate Arm2- Arm1||14.1|-24.9|
91637515|NCT01072175|183167152|SUPERIORITY_OR_OTHER||Unconditional exact method|15.0|||||TWO_SIDED|95.0|-4.9|33.7||||||Difference in response rate Arm3 - Arm1||33.7|-4.9|
91671994|NCT01011556|183238822|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.56|||<|0.001|TWO_SIDED|90.0|-4.652|-2.464|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.464|-4.652|<0.001
91715642|NCT01435759|183322235|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.15|STANDARD_ERROR_OF_MEAN|1.01||0.005|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
91485467|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.3115|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.3115
91637516|NCT01072175|183167153|SUPERIORITY_OR_OTHER||Response rate|6.0|||||TWO_SIDED|95.0|5.1|26.8||||||||26.8|5.1|
91637517|NCT01072175|183167154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0048|TWO_SIDED|95.0|0.38|0.87|||Log Rank||HRs were estimated using the Pike estimator.|||0.87|0.38|0.0048
91637518|NCT01072175|183167154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Log Rank||HRs were estimated using the Pike estimator.|||0.68|0.29|<0.0001
91637519|NCT01072175|183167156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1667|TWO_SIDED|95.0|0.45|1.18|||Log Rank||HRs were estimated using the Pike estimator.|||1.18|0.45|0.1667
91637520|NCT01072175|183167156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0119|TWO_SIDED|95.0|0.32|0.9|||Log Rank||HRs were estimated using the Pike estimator.|||0.90|0.32|0.0119
91637521|NCT01072175|183167164|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.1|2.08|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||2.08|1.10|
91671995|NCT01011556|183238823|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.53|STANDARD_ERROR_OF_MEAN|0.687|<|0.001|TWO_SIDED|90.0|-5.663|-3.392||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-3.392|-5.663|<0.001
91637522|NCT01072175|183167166|NON_INFERIORITY_OR_EQUIVALENCE|Following loge transformation, AUC(0-tau) of dabrafenib was analyzed by a linear mixed effect model with dosing chort and day as fixed effects and subject as random effect. Based on the model, geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|Geometric Mean Ratio|1.23|||||TWO_SIDED|90.0|0.89|1.69|||||Geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|||1.69|0.89|
91637523|NCT01072175|183167166|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, AUC(0-tau) of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5, 2 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were then provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.84|1.44|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||1.44|0.84|
91637524|NCT02839330|183167200|EQUIVALENCE|Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.13||||||aH5N1c Lot #1 vs. aH5N1c Lot #2||1.13|0.90|
91637525|NCT02839330|183167200|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.08||||||aH5N1c Lot #2 vs. aH5N1c Lot #3||1.08|0.86|
91637526|NCT02839330|183167200|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.97|||||TWO_SIDED|95.0|0.87|1.09||||||aH5N1c Lot #1 vs. aH5N1c Lot #3||1.09|0.87|
91637527|NCT00218439|183167215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91637528|NCT00218439|183167216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
91637529|NCT00218439|183167217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
91637530|NCT00218439|183167218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
91671996|NCT01011556|183238823|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.94|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|90.0|-5.086|-2.8||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.800|-5.086|<0.001
91792830|NCT02751931|183463235|OTHER||Mean Difference (Net)|31.83||||0.042|TWO_SIDED|95.0|1.3|62.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||62.4|1.3|0.042
91637531|NCT00218439|183167219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
91637532|NCT02615158|183167220|EQUIVALENCE|If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.555|TWO_SIDED|95.0|-0.17|0.31||The alpha for statistical significance is set at 0.05.|Mixed Models Analysis||This is to compare change in maternal lifestyle group to child safety group.|H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.||0.31|-0.17|0.555
91637533|NCT02615158|183167220|EQUIVALENCE|95% CI|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2|TWO_SIDED|95.0|-0.08|0.39||Two-side test|Mixed Models Analysis||This is to compare the Responsive Parenting to the safety intervention group.|||0.39|-0.08|0.200
91637534|NCT02615158|183167221|EQUIVALENCE|95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.|Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.32||0.739|TWO_SIDED|95.0|-0.74|0.52||The alpha for statistical significance is set at 0.05|Mixed Models Analysis||This is to compare maternal lifestyle to child safety group.|H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.||0.52|-0.74|0.739
91637535|NCT02615158|183167221|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.32||0.904|TWO_SIDED|95.0|-0.66|0.59||The alpha for statistical significance was set at 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to the child safety group.|H0: There are no differences in the change over time between responsive parenting and child safety groups.||0.59|-0.66|0.904
91637536|NCT02615158|183167222|EQUIVALENCE|The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.|Slope|3.31|STANDARD_ERROR_OF_MEAN|2.4||0.168|TWO_SIDED|95.0|-1.4|8.02||Alpha is set at 0.05.|Mixed Models Analysis|||H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.||8.02|-1.4|0.168
91637537|NCT02615158|183167222|EQUIVALENCE|95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.|Slope|0.82|STANDARD_ERROR_OF_MEAN|2.39||0.733|TWO_SIDED|95.0|-3.88|5.52|||Mixed Models Analysis||This is to compare the responsive feeding group to child safety group.|H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time||5.52|-3.88|0.733
91637538|NCT02615158|183167223|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.|Slope|3.3|STANDARD_ERROR_OF_MEAN|2.49||0.186|TWO_SIDED|95.0|-1.6|8.2||Alpha is set at 0.05.|Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.||8.2|-1.6|0.186
91671997|NCT01011556|183238823|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.53|STANDARD_ERROR_OF_MEAN|0.665|<|0.001|TWO_SIDED|90.0|-4.627|-2.43||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.430|-4.627|<0.001
91637539|NCT02615158|183167223|EQUIVALENCE|95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|95.0|-4.97|4.91||Alpha is set to 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|H0 is there is no difference in the change of maternal HEI score over time between the two groups.||4.91|-4.97|0.990
91637540|NCT02615158|183167224|EQUIVALENCE|A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.|Slope|23.67|STANDARD_ERROR_OF_MEAN|11.03||0.034|TWO_SIDED|95.0|1.88|45.46||Alpha is set at 0.05.|Mixed Models Analysis||This is for maternal lifestyle group compared to safety control group.|Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.||45.46|1.88|0.034
91637541|NCT02615158|183167224|EQUIVALENCE|H0 is that there is no difference between the change of MVPA over time between the two groups.|Slope|13.52|STANDARD_ERROR_OF_MEAN|10.89||0.216|TWO_SIDED|95.0|-7.98|35.03|||Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|||35.03|-7.98|0.216
91637542|NCT02615158|183167225|EQUIVALENCE|The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.|Slope|10.97|STANDARD_ERROR_OF_MEAN|4.82||0.024|TWO_SIDED|95.0|1.46|20.48|||Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|H0 is that there is no difference in the change of maternal MVPA over time between the two groups.||20.48|1.46|0.024
91637543|NCT02615158|183167225|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|0.98|STANDARD_ERROR_OF_MEAN|4.94||0.804|TWO_SIDED|95.0|-8.76|10.72|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|H0 is that there is no significant difference in the change of maternal MVPA between the two groups.||10.72|-8.76|0.804
91671998|NCT01011556|183238823|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.5|STANDARD_ERROR_OF_MEAN|0.818|<|0.001|TWO_SIDED|90.0|-8.856|-6.151||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.151|-8.856|<0.001
91671999|NCT01011556|183238823|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.46|STANDARD_ERROR_OF_MEAN|0.83||0.001|TWO_SIDED|90.0|-8.835|-6.091||p-value for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.091|-8.835|0.001
91672000|NCT01011556|183238823|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-6.19|STANDARD_ERROR_OF_MEAN|0.802||0.001|TWO_SIDED|90.0|-7.51|-4.86||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-4.860|-7.510|0.001
91672001|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
91672002|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
91485468|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0270
91672003|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
91637544|NCT02615158|183167226|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.056|TWO_SIDED|95.0|-0.78|0.06||Alpha is set at 0.05 for statistical significance.|Mixed Models Analysis||This is to compare maternal lifestyle group to the child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.06|-0.78|0.056
91637545|NCT02615158|183167226|EQUIVALENCE|Alpha is set at 0.05 to indicate statistical significance.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.896|TWO_SIDED|95.0|-0.39|0.45|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.45|-0.39|0.896
91637546|NCT02257970|183167228|EQUIVALENCE|The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||<|0.0001|||||||t-test, 2 sided|paired t-test||For the analysis, the 4-month post-minus-pre change in this score for ketoprofen was compared.||||<0.0001
91637547|NCT02257970|183167229|EQUIVALENCE|Pre-to-post comparison: the likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.6|||||||t-test, 2 sided|Paired t-test||||||=0.6
91637548|NCT02257970|183167229|EQUIVALENCE|Pre-to-Post comparison: The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.01|||||||t-test, 2 sided|paired t-test||||||=0.01
91637549|NCT00883896|183167243|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-5.9||||0.558|TWO_SIDED|95.0|-25.0|13.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.3|-25.0|0.558
91672004|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
91672005|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
91672006|NCT01011556|183238824|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.003
91672007|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
91672008|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
91672009|NCT01011556|183238824|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.029
91672010|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
91715643|NCT01435759|183322236|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.16|STANDARD_ERROR_OF_MEAN|0.75||0.011|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.|||||0.011
91672011|NCT01011556|183238824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
91672012|NCT01011556|183238824|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.047
91715644|NCT01435759|183322236|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|1.95|STANDARD_ERROR_OF_MEAN|0.75||0.023|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.023
91637550|NCT00883896|183167243|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.4||||0.251|TWO_SIDED|95.0|-30.1|7.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-30.1|0.251
91637551|NCT00883896|183167243|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.7||||0.707|TWO_SIDED|95.0|-21.7|14.4|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.4|-21.7|0.707
91637552|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.991|TWO_SIDED|95.0|-14.8|14.7|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.7|-14.8|0.991
91637553|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-4.8||||0.518|TWO_SIDED|95.0|-18.4|8.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-18.4|0.518
91637554|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|0.781||||0.63|TWO_SIDED|95.0|-16.9|9.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.8|-16.9|0.630
91637555|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|9.4||||0.295|TWO_SIDED|95.0|-8.3|27.0|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||27.0|-8.3|0.295
91637556|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|-3.4||||0.686|TWO_SIDED|95.0|-19.3|12.5|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.5|-19.3|0.686
91715645|NCT01435759|183322236|SUPERIORITY_OR_OTHER_LEGACY||MCP-Mod Analysis|2.47|STANDARD_ERROR_OF_MEAN|0.75||0.003|TWO_SIDED||||||Least Squares Means|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
91637557|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.772|TWO_SIDED|95.0|-13.2|18.2|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.2|-13.2|0.772
91672013|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.822
91672014|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.406
91637558|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|12.8||||0.201|TWO_SIDED|95.0|-6.5|32.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||32.0|-6.5|0.201
91637559|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-10.4||||0.256|TWO_SIDED|95.0|-27.3|6.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.5|-27.3|0.256
91672015|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.312||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.312
91672016|NCT01011556|183238825|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
91672017|NCT01011556|183238825|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
91672018|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.952
91672019|NCT01011556|183238825|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
91672020|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.011
91672021|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.997
91672022|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.003
91672023|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.112
91715646|NCT01435759|183322236|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.22|STANDARD_ERROR_OF_MEAN|0.76||0.009|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.009
91715647|NCT01435759|183322236|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.37|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
91715648|NCT01435759|183322237|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.45|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax|||||<0.001
91672024|NCT01011556|183238825|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.988
91672025|NCT01011556|183238826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
91672026|NCT01011556|183238826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
91672027|NCT01011556|183238826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
91672028|NCT01483625|183238866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.055||0.3025|TWO_SIDED|95.0|-0.0516|0.1654|||Mixed effect repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Random:Patient. A spatial power covariance structure was used.||Tiotropium 18 mcg minus Placebo||0.1654|-0.0516|0.3025
91715649|NCT01435759|183322237|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.52|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.|||||0.002
91672029|NCT01483625|183238867|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|STANDARD_ERROR_OF_MEAN|0.44||0.7823|TWO_SIDED|95.0|0.9053|1.078|||2sample t quantiles with pooled variance|||Comparison Tiotropium 18 mcg Vs Placebo||1.0780|0.9053|0.7823
91715650|NCT01435759|183322237|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.|||||<0.001
91485469|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0008
91715651|NCT01435759|183322237|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||<0.001
91715652|NCT01435759|183322237|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.|||||<0.001
91485470|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0683|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0683
91672030|NCT01483625|183238868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0099|STANDARD_ERROR_OF_MEAN|0.0806||0.9025|TWO_SIDED|95.0|-0.1489|0.1686||Comparison Tiotropium 18 mcg Vs Placebo at Week 12|Mixed effects repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Patient was random. A spatial power covariance structure was used.||||0.1686|-0.1489|0.9025
91672031|NCT01483625|183238871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.061|STANDARD_ERROR_OF_MEAN|3.0115||0.1797|TWO_SIDED|95.0|-10.0157|1.8938|||t-test, 2 sided|95% confidence interval is based on 2 sample t quantiles using pooled variance.||Comparison Tiotropium 18 mcg Vs Placebo Over 12 Weeks||1.8938|-10.0157|0.1797
91672032|NCT00707447|183238957|SUPERIORITY_OR_OTHER||||||<|0.05||||||There was only one primary outcome variable, thus no adjustments for multiple comparisons were made.|t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
91672033|NCT00707447|183238958|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
91672034|NCT00707447|183238959|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672035|NCT00707447|183238960|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672036|NCT00707447|183238961|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672037|NCT00707447|183238962|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672038|NCT00707447|183238963|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672039|NCT00707447|183238964|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672040|NCT00707447|183238965|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672041|NCT00707447|183238966|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91672042|NCT00508027|183238967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|1.7|<|0.05|||||||t-test, 2 sided|||Ho: There is no change in plasma biomarker levels before and after simivastatin treatment. With 12 patients in each group and assuming a 5% risk of Type I error (two-tailed α = 0.05) and estimated SD for the change in NOx (or sVCAM-1) of 48%, power will be 80% to detect a 40% change from baseline for each group, and a 55% difference in the change in biomarker levels between dose groups. Matched paired t-tests were used to measure changes in biomarker levels from baseline.||||<0.05
91715653|NCT01435759|183322238|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.11|STANDARD_ERROR_OF_MEAN|1.07||1|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis Method|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||1.000
91792831|NCT02751931|183463235|OTHER||Mean Difference (Net)|38.14||||0.121|TWO_SIDED|95.0|-11.0|87.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||87.3|-11.0|0.121
91637560|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.519|TWO_SIDED|95.0|-11.4|23.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.5|-11.4|0.519
91637561|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|16.7||||0.094|TWO_SIDED|95.0|-1.9|35.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||35.2|-1.9|0.094
91637562|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.8||||0.76|TWO_SIDED|95.0|-14.4|20.1|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||20.1|-14.4|0.760
91637563|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.95|TWO_SIDED|95.0|-16.8|18.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.0|-16.8|0.950
91637564|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|13.6||||0.185|TWO_SIDED|95.0|-5.9|33.0|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||33.0|-5.9|0.185
91637565|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.2||||0.982|TWO_SIDED|95.0|-18.8|19.3|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||19.3|-18.8|0.982
91637566|NCT00883896|183167244|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.6||||0.223|TWO_SIDED|95.0|-29.0|5.8|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-29.0|0.223
91637567|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.885|TWO_SIDED|95.0|-6.8|5.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-6.8|0.885
91637568|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.18|TWO_SIDED|95.0|-3.4|15.6|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.6|-3.4|0.180
91637569|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-2.7||||0.277|TWO_SIDED|95.0|-6.5|1.1|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||1.1|-6.5|0.277
91637570|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.7||||0.74|TWO_SIDED|95.0|-7.9|11.3|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.3|-7.9|0.740
91637571|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.4||||0.934|TWO_SIDED|95.0|-9.3|10.1|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||10.1|-9.3|0.934
91637572|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.6||||0.876|TWO_SIDED|95.0|-7.7|6.4|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.4|-7.7|0.876
91637573|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.1||||0.842|TWO_SIDED|95.0|-11.4|9.2|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.2|-11.4|0.842
91637574|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.1||||0.509|TWO_SIDED|95.0|-8.1|16.3|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||16.3|-8.1|0.509
91792832|NCT02751931|183463236|OTHER||Mean Difference (Net)|0.35||||0.818|TWO_SIDED|95.0|-2.7|3.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||3.4|-2.7|0.818
91637575|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.504|TWO_SIDED|95.0|-7.0|15.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.0|-7.0|0.504
91637576|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.373|TWO_SIDED|95.0|-6.3|17.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||17.0|-6.3|0.373
91637577|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.4||||0.499|TWO_SIDED|95.0|-12.0|5.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.2|-12.0|0.499
91637578|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|7.0||||0.244|TWO_SIDED|95.0|-4.2|18.3|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.3|-4.2|0.244
91637579|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.2||||0.979|TWO_SIDED|95.0|-15.0|14.6|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.6|-15.0|0.979
91637580|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-9.8||||0.166|TWO_SIDED|95.0|-21.8|2.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||2.2|-21.8|0.166
91637581|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.5||||0.947|TWO_SIDED|95.0|-13.2|14.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.2|-13.2|0.947
91637582|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|8.3||||0.286|TWO_SIDED|95.0|-7.1|23.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.8|-7.1|0.286
91637583|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.6||||0.822|TWO_SIDED|95.0|-15.0|11.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-15.0|0.822
91637584|NCT00883896|183167245|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.986|TWO_SIDED|95.0|-12.3|12.1|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.1|-12.3|0.986
91637585|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
91637586|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.188|TWO_SIDED|95.0|-2.3|7.3|||Cochran-Mantel-Haenszel|||Week 2:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-2.3|0.188
91637587|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 2: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.0|0.0|
91637588|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.1||||0.699|TWO_SIDED|95.0|-4.5|6.6|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.6|-4.5|0.699
91637589|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.155|TWO_SIDED|95.0|-3.0|13.8|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.8|-3.0|0.155
91672043|NCT02013531|183238988|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
91672044|NCT02013531|183238989|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 6.||||<0.0001
91715654|NCT01435759|183322238|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.43|STANDARD_ERROR_OF_MEAN|1.06||0.942|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.942
91792833|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.53||||0.114|TWO_SIDED|95.0|-1.2|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||0.1|-1.2|0.114
91792834|NCT02751931|183463236|OTHER||Mean Difference (Net)|-1.14||||0.052|TWO_SIDED|95.0|-2.3|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||0.0|-2.3|0.052
91792835|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.87||||0.066|TWO_SIDED|95.0|-1.8|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.1|-1.8|0.066
91792836|NCT02751931|183463236|OTHER||Mean Difference (Net)|1.16||||0.674|TWO_SIDED|95.0|-4.4|6.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||6.7|-4.4|0.674
91792837|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.65||||0.278|TWO_SIDED|95.0|-1.9|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||0.6|-1.9|0.278
91792838|NCT02751931|183463236|OTHER||Mean Difference (Net)|0.37||||0.871|TWO_SIDED|95.0|-4.2|5.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||5.0|-4.2|0.871
91792839|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.65||||0.153|TWO_SIDED|95.0|-1.6|0.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||0.3|-1.6|0.153
91792840|NCT02751931|183463236|OTHER||Mean Difference (Net)|0.18||||0.922|TWO_SIDED|95.0|-3.5|3.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||3.9|-3.5|0.922
91792841|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.75||||0.047|TWO_SIDED|95.0|-1.5|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.0|-1.5|0.047
91485471|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.2226|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2226
91637590|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.0||||0.546|TWO_SIDED|95.0|-2.9|0.9|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.9|-2.9|0.546
91637591|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
91672045|NCT02013531|183238995|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
91672046|NCT02240186|183239010|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
91672047|NCT02240186|183239011|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
91672048|NCT02240186|183239012|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
91672049|NCT00860743|183239053|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|ANOVA|||||||0.001
91672050|NCT00860743|183239054|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.2
91672051|NCT02776553|183239060|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
91792842|NCT02751931|183463236|OTHER||Mean Difference (Net)|-1.98||||0.018|TWO_SIDED|95.0|-3.6|-0.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||-0.4|-3.6|0.018
91792843|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.81||||0.07|TWO_SIDED|95.0|-1.7|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||0.1|-1.7|0.070
91792844|NCT02751931|183463236|OTHER||Mean Difference (Net)|-0.94||||0.083|TWO_SIDED|95.0|-2.0|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.1|-2.0|0.083
91792845|NCT02751931|183463236|OTHER||Mean Difference (Net)|-1.12||||0.064|TWO_SIDED|95.0|-2.3|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.1|-2.3|0.064
91792846|NCT02751931|183463237|OTHER|||||||0.692||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||||0.692
91792847|NCT02751931|183463237|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||||0.018
91792848|NCT02751931|183463237|OTHER|||||||0.061||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||0.061
91792849|NCT02751931|183463237|OTHER|||||||0.008||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.008
91792850|NCT02751931|183463237|OTHER|||||||0.612||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||||0.612
91792851|NCT02751931|183463237|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||||0.018
91792852|NCT02751931|183463237|OTHER|||||||0.858||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||||0.858
91715655|NCT01435759|183322238|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.21|STANDARD_ERROR_OF_MEAN|1.06||0.995|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.995
91637592|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.2||||0.269|TWO_SIDED|95.0|-1.8|6.1|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.1|-1.8|0.269
91637593|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.723|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.723
91637594|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
91637595|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 8: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the cochran method.||0.0|0.0|
91637596|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.125|TWO_SIDED|95.0|-1.3|9.4|||Cochran-Mantel-Haenszel|||Week 8:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.4|-1.3|0.125
91637597|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.0||||0.071|TWO_SIDED|95.0|-1.7|11.8|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-1.7|0.071
91637598|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.317|TWO_SIDED|95.0|-1.2|5.1|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.1|-1.2|0.317
91637599|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.28|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.280
91637600|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.892|TWO_SIDED|95.0|-7.6|8.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-7.6|0.892
91637601|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.903|TWO_SIDED|95.0|-8.3|7.2|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.2|-8.3|0.903
91637602|NCT00883896|183167246|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.7||||0.625|TWO_SIDED|95.0|-7.2|3.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||3.8|-7.2|0.625
91792853|NCT02751931|183463237|OTHER|||||||0.004||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||||0.004
91637603|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.900
91792854|NCT02751931|183463237|OTHER|||||||0.003||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||0.003
91637604|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.522
91637605|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.147|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.147
91637606|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.534
91637607|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.206
91637608|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.070
91637609|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.936|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.936
91637610|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.625
91672052|NCT02776553|183239061|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
91485472|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0823
91637611|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.586|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.586
91637612|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.685
91637613|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.340
91637614|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.212
91637615|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.455|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.455
91637616|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.145
91637617|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.660
91637618|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.050
91637619|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.428
91637620|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.160
91637621|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.757
91637622|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.408|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.408
91637623|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.983|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.983
91637624|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.374
91637625|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.992
91637626|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.422
91637627|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.743|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.743
91637628|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.188
91637629|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.385|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.385
91637630|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.148
91637631|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.304
91637632|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.552
91792855|NCT02751931|183463237|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||< 0.001
91637633|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.494
91637634|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.421
91637635|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.418|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.418
91637636|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.235
91637637|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.268
91672053|NCT02776553|183239062|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
91637638|NCT00883896|183167258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.957
91637639|NCT01177943|183167309|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of geometric means.|Ratio of Geometric LS Mean values|0.945|||||TWO_SIDED|90.0|0.858|1.04|||ANOVA|||||1.04|0.858|
91637640|NCT01177943|183167310|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of the ratio of geometric means.|Ratio of AUC(0-tlast) values|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||||1.07|1.00|
91637641|NCT02467504|183167314|OTHER|||||||0.53|||||||Chi-squared|||||||0.530
91637642|NCT02467504|183167315|OTHER|||||||0.315|||||||Chi-squared|||||||0.315
91672054|NCT03827018|183239071|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0263|TWO_SIDED|95.0|0.15|0.92||Comparison of KPL-301 and placebo with respect to time to flare calculated by using a log-rank test stratified by randomization strata.|Log Rank||95% confidence interval was calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata.|||0.92|0.15|0.0263
91672055|NCT03827018|183239072|SUPERIORITY||Difference in proportions|33.3||||0.0038|TWO_SIDED|95.0|10.7|55.8||Two-sided p-value and 95% CI for the difference in sustained remission between two arms using normal approximation. Placebo arm is the reference.|normal approximation|||Secondary endpoints were analyzed in hierarchical order.||55.8|10.7|0.0038
91672056|NCT03827018|183239073|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0277|TWO_SIDED|95.0|0.27|0.95||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.95|0.27|0.0277
91672057|NCT03827018|183239074|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0378|TWO_SIDED|95.0|0.19|0.98||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.98|0.19|0.0378
91637643|NCT02467504|183167316|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
91637644|NCT02467504|183167317|OTHER|||||||0.015|||||||Mixed Models Analysis|||||||0.015
91637645|NCT02467504|183167318|OTHER|Chi||||||0.474|||||||Chi-squared|||||||0.474
91637646|NCT02467504|183167319|OTHER|description of Treg cells in CD4+ T cells||||||0.665|||||||Mixed Models Analysis|||||||0.665
91637647|NCT02467504|183167320|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
91637648|NCT02467504|183167321|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
91637649|NCT02467504|183167322|OTHER|||||||0.2|||||||Chi-squared|||||||0.200
91637650|NCT02467504|183167323|OTHER|||||||0.373|||||||Chi-squared|||||||0.373
91637651|NCT02467504|183167324|OTHER|||||||0.565|||||||Chi-squared|||||||0.565
91672058|NCT03827018|183239075|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0651|TWO_SIDED|95.0|0.22|1.06||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||1.06|0.22|0.0651
91792856|NCT02751931|183463237|OTHER|||||||0.045||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||||0.045
91792857|NCT02751931|183463237|OTHER|||||||0.002||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||||0.002
91485473|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.1459|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.1459
91637652|NCT02467504|183167325|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||||||0.221
91637653|NCT02467504|183167326|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
91637654|NCT02467504|183167327|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
91637655|NCT02467504|183167328|OTHER|||||||0.881|||||||Mixed Models Analysis|||||||0.881
91637656|NCT02467504|183167329|OTHER|||||||0.422|||||||Mixed Models Analysis|||||||0.422
91637657|NCT02467504|183167330|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
91637658|NCT02467504|183167331|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91637659|NCT02467504|183167332|OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
91637660|NCT03982069|183167352|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
91637661|NCT03982069|183167353|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
91637662|NCT03982069|183167354|OTHER||||||<|0.001||||||Day 28 for all listed antigens|Chi-squared|||||||<0.001
91637663|NCT03982069|183167354|OTHER|||||||0.4||||||Day 0, A/H1N1-A/Brisbane|Chi-squared|||||||0.40
91637664|NCT03982069|183167354|OTHER|||||||0.36||||||Day 0 A/H1N1-A/Kansas egg grown virus|Chi-squared|||||||0.36
91637665|NCT03982069|183167354|OTHER|||||||0.08||||||Day 0 A/H1N1-A/Kansas cell grown virus|Chi-squared|||||||0.08
91637666|NCT03982069|183167354|OTHER|||||||0.91||||||Day 0 B/Victoria-B/Colorado|Chi-squared|||||||0.91
91637667|NCT03982069|183167354|OTHER|||||||0.31||||||Day 0 B/Yamagata-B/Phuket|Chi-squared|||||||0.31
91637668|NCT03982069|183167355|OTHER|||||||0.79||||||Day 0 A/H1N1-A/Brisbane|t-test, 2 sided|||||||0.79
91637669|NCT03982069|183167355|OTHER|||||||0.79||||||Day 0 A/H3N2-A/Kansas egg grown virus|t-test, 2 sided|||||||0.79
91637670|NCT03982069|183167355|OTHER|||||||0.56||||||Day 0 A/H3N2-A/Kansas cell grown virus|t-test, 2 sided|||||||0.56
91637671|NCT03982069|183167355|OTHER|||||||0.95||||||Day 0 B/Victoria-B/Colorado|t-test, 2 sided|||||||0.95
91637672|NCT03982069|183167355|OTHER|||||||0.44||||||Day 0 B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.44
91637673|NCT03982069|183167355|OTHER||||||<|0.001||||||Day 28 for all listed variables|t-test, 2 sided|||||||<0.001
91637674|NCT03982069|183167356|OTHER|||||||0.83|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii66-egg based antigen||||||0.83
91637675|NCT03982069|183167356|OTHER|||||||0.79|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii70-cell based antigen||||||0.79
91637676|NCT03982069|183167356|OTHER|||||||0.65|||||||Chi-squared|Day 0: A/H1N1-A/Delaware||||||0.65
91637677|NCT03982069|183167356|OTHER|||||||0.06|||||||Chi-squared|Day 0: A/H3N2-A/Hong Kong||||||0.06
91637678|NCT03982069|183167356|OTHER|||||||0.98|||||||Chi-squared|Day 0: B/Victoria-B/Washington||||||0.98
91672059|NCT03827018|183239076|OTHER|Descriptive statistic|Least Squares (LS) means difference|-326.45||||0.0667|TWO_SIDED|95.0|-675.99|23.09||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable.|ANCOVA|||||23.09|-675.99|0.0667
91672060|NCT03827018|183239077|OTHER|Descriptive statistic|Difference in percentages|31.0||||0.0201|TWO_SIDED|95.0|11.1|50.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||50.8|11.1|0.0201
91672061|NCT03827018|183239078|OTHER|Descriptive statistic|Difference in percentages|9.5||||0.5533|TWO_SIDED|95.0|-8.7|27.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||27.8|-8.7|0.5533
91672062|NCT03827018|183239079|OTHER|Descriptive statistics|Difference in percentages|39.3||||0.0031|TWO_SIDED|95.0|17.2|61.3||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||61.3|17.2|0.0031
91637679|NCT03982069|183167356|OTHER|||||||0.24|||||||Chi-squared|Day 0: B/Yamagata-B/Phuket||||||0.24
91637680|NCT03982069|183167356|OTHER||||||<|0.01|||||||Chi-squared|Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket||||||<0.01
91637681|NCT03982069|183167356|OTHER|||||||0.66|||||||Chi-squared|A/H3N2-A/Hong Kong||||||0.66
91637682|NCT03982069|183167357|OTHER|||||||0.22||||||Day 0: A/H1N1-A/Hawaii66 egg based antigen|t-test, 2 sided|||||||0.22
91637683|NCT03982069|183167357|OTHER|||||||0.25||||||Day 0: A/H1N1-A/Hawaii70 cell based antigen|t-test, 2 sided|||||||0.25
91637684|NCT03982069|183167357|OTHER|||||||0.13||||||Day 0: A/H1N1-A/Delaware|t-test, 2 sided|||||||0.13
91637685|NCT03982069|183167357|OTHER|||||||0.06||||||Day 0: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.06
91637686|NCT03982069|183167357|OTHER|||||||0.78||||||Day 0: B/Victoria-B/Washington|t-test, 2 sided|||||||0.78
91637687|NCT03982069|183167357|OTHER|||||||0.36||||||Day 0: B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.36
91637688|NCT03982069|183167357|OTHER||||||<|0.0001||||||Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket|t-test, 2 sided|||||||<0.0001
91637689|NCT03982069|183167357|OTHER|||||||0.01||||||Day 28: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.01
91637690|NCT00078715|183167363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.004|STANDARD_ERROR_OF_MEAN|1.141||0.527|TWO_SIDED|95.0|-4.26|2.251||The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.|Mixed Models Analysis|A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.||The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.||2.251|-4.260|.527
91637691|NCT01020812|183167372|SUPERIORITY_OR_OTHER||proportion of participants|0.286|||||TWO_SIDED|95.0|0.031|0.636|||||The data was analyzed in a competing risk model with death as a competing risk. The proportion of 0.286 is the cumulative incidence function at 12 months.|The data was analyzed in a competitive risk model with the cumulative incidence function as the estimator. Death and other progression were competitive risks.||0.636|0.031|
91637692|NCT01020812|183167373|SUPERIORITY_OR_OTHER||probability|0.4|||||TWO_SIDED||||||||This is the overall survival probability at 18 months.|The data was analyzed using the Kaplan Meier estimator.||||
91637693|NCT05040295|183167377|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|102.5|||||TWO_SIDED|90.0|94.21|111.51|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||111.51|94.21|
91637694|NCT05040295|183167377|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|106.65|||||TWO_SIDED|90.0|100.07|113.66|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||113.66|100.07|
91637695|NCT05040295|183167378|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|101.12|||||TWO_SIDED|90.0|88.25|115.87|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.87|88.25|
91637696|NCT05040295|183167378|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|90.11|||||TWO_SIDED|90.0|78.49|103.44|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||103.44|78.49|
91637697|NCT00953849|183167381|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
91637698|NCT00953849|183167382|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
91637699|NCT00953849|183167383|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
91637700|NCT00953849|183167384|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
91637701|NCT01801475|183167388|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
91637702|NCT01801475|183167389|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
91672063|NCT03827018|183239080|OTHER|Descriptive statistics|Least Squares (LS) means difference|-380.82||||0.1629|TWO_SIDED|95.0|-919.66|158.02||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable|ANCOVA|||||158.02|-919.66|0.1629
91672064|NCT01998243|183239088|SUPERIORITY||Risk Ratio (RR)|1.2||||0.689|TWO_SIDED|95.0|0.53|2.6|||Chi-squared||risk ratio (RR)|||2.60|0.53|0.689
91672065|NCT01998243|183239089|SUPERIORITY||Risk Ratio (RR)|1.59||||0.144|TWO_SIDED|95.0|0.84|3.01|||Chi-squared||all in all balloon and postsurgical morbidity in group A vs. group B.|||3.01|0.84|0.144
91672066|NCT01998243|183239090|SUPERIORITY|||||||0.937|||||||Wilcoxon (Mann-Whitney)|||||||0.937
91672067|NCT01998243|183239091|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91672068|NCT01998243|183239092|SUPERIORITY|||||||0.673|||||||Fisher Exact|||||||0.673
91672069|NCT04569786|183239120|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|0.92||||0.649|TWO_SIDED|90.0|0.63|1.34||1-sided|Longitudinal data analysis (LDA) method|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.34|0.63|0.649
91672070|NCT04569786|183239120|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.0||||0.495||90.0|0.68|1.48||1-sided|LDA model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.48|0.68|0.495
91672071|NCT04569786|183239120|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.1||||0.339|TWO_SIDED|90.0|0.75|1.6||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.60|0.75|0.339
91485474|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.2610
91637703|NCT00421928|183167397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.05||95.0|-1.04|-0.33|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and pooled analysis center as factors and baseline pain intensity score as a covariate.||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.33|-1.04|<0.05
91672072|NCT04569786|183239120|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|2.26|||<|0.001|TWO_SIDED|90.0|1.56|3.28||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||3.28|1.56|<0.001
91672073|NCT02646917|183239146|SUPERIORITY||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.||||<0.008
91672074|NCT02646917|183239147|SUPERIORITY||||||<|0.001|||||||Wilcoxen signed-rank test|||Null hypothesis 4 (no change).||||<.001
91672075|NCT02646917|183239148|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zero||||<0.01
91672076|NCT02646917|183239149|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).||||<0.01
91672077|NCT02646917|183239150|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||||<0.01
91672078|NCT00680186|183239157|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.13||||0.0002||95.0|0.69|1.85||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint|Regression, Cox|Patients without events are censored at the end of ptp.||Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.85|0.69|0.0002
91715656|NCT01435759|183322238|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.32|STANDARD_ERROR_OF_MEAN|1.07||0.978|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||0.978
91637704|NCT00444028|183167409|OTHER|"The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|Slope|0.909|||||TWO_SIDED|90.0|0.832|0.987||||||Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered.||0.987|0.832|
91637705|NCT03039686|183167422|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.17|1.27|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age Interactive response system (IXRS) Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||1.27|-2.17|
91637706|NCT03039686|183167422|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.1|2.26|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.26|-1.10|
91637707|NCT03039686|183167424|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.21|0.2|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.20|-0.21|
91637708|NCT03039686|183167424|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.12|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.12|
91637709|NCT03039686|183167426|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
91637710|NCT03039686|183167426|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
91637711|NCT03039686|183167428|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.08|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.08|
91637712|NCT03039686|183167428|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.17|0.18|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.18|-0.17|
91637713|NCT03039686|183167430|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-6.76|2.77|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.77|-6.76|
91637714|NCT03039686|183167430|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-3.71|5.63|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||5.63|-3.71|
91637715|NCT03039686|183167433|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|11.5|||TWO_SIDED|95.0|-21.1|24.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||24.6|-21.1|
91637716|NCT03039686|183167433|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|11.3|||TWO_SIDED|95.0|-11.0|33.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||33.6|-11.0|
91637717|NCT03947333|183167469|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.221|TWO_SIDED||||||t-test, 1 sided|||||||0.221
91637718|NCT03947333|183167469|OTHER||fixed-effects estimate of intervention|0.846||||0.559|TWO_SIDED|95.0|-1.99|3.68|||Mixed Models Analysis|||Mixed effects model||3.68|-1.99|0.559
91637719|NCT03947333|183167470|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.532|TWO_SIDED||||||t-test, 1 sided|||||||0.532
91637720|NCT03947333|183167471|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.086|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.086
91637721|NCT03947333|183167471|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.562|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.562
91637722|NCT03947333|183167471|OTHER||fixed-effects estimate of intervention|0.348||||0.451|TWO_SIDED|95.0|-0.557|1.254|||Mixed Models Analysis|||Mixed Effects Model||1.254|-0.557|0.451
91637723|NCT03947333|183167472|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.270
91637724|NCT03947333|183167472|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.299|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.299
91637725|NCT03947333|183167472|OTHER||fixed-effects estimate of intervention|0.1||||0.917|TWO_SIDED|95.0|-1.786|1.986|||Mixed Models Analysis|||Mixed effects model||1.986|-1.786|0.917
91637726|NCT03947333|183167473|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.093|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.093
91637727|NCT03947333|183167473|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.034|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.034
91637728|NCT03947333|183167473|OTHER||fixed-effects estimate of intervention|0.242||||0.103|TWO_SIDED|95.0|-0.049|0.533|||Mixed Models Analysis|||Mixed Effects Model||0.533|-0.049|0.103
91637729|NCT03947333|183167474|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.116|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.116
91637730|NCT03947333|183167474|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED||||||t-test, 1 sided|||||||0.009
91637731|NCT03947333|183167474|OTHER||fixed-effects estimate of intervention|0.183||||0.178|TWO_SIDED|95.0|-0.084|0.451|||Mixed Models Analysis|||Mixed Effects Model||0.451|-0.084|0.178
91637732|NCT03947333|183167475|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.188|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.188
91637733|NCT03947333|183167475|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.749|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.749
91637734|NCT03947333|183167475|OTHER||fixed-effects estimate of intervention|0.031||||0.847|TWO_SIDED|95.0|-0.288|0.351|||Mixed Models Analysis|||Mixed Effects Model||0.351|-0.288|0.847
91637735|NCT03947333|183167476|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.182|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.182
91637736|NCT03947333|183167476|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.158|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.158
91637737|NCT03947333|183167476|OTHER||fixed-effects estimate of intervention|0.107||||0.612|TWO_SIDED|95.0|-0.305|0.519|||Mixed Models Analysis|||Mixed Effects Model||0.519|-0.305|0.612
91672079|NCT00680186|183239157|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the RD based on KM estimates|Risk Difference (Percentage)|0.2|||<|0.0001||95.0|-1.0|1.3||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.3|-1.0|<0.0001
91672080|NCT00680186|183239157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||||95.0|0.64|1.8|||Regression, Cox|Patients without events are censored at the earliest of last contact date or day 180.||HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.||1.8|0.64|
91672081|NCT00680186|183239158|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.6932||95.0|-1.1|1.6|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.6|-1.1|0.6932
91672082|NCT00680186|183239158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6383||95.0|0.75|1.6|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.60|0.75|0.6383
91672083|NCT00680186|183239159|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.6||||0.1703||95.0|-0.3|1.5|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.5|-0.3|0.1703
91672084|NCT00680186|183239159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.1054||95.0|0.9|3.01|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.01|0.90|0.1054
91672085|NCT00680186|183239160|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.4||||0.2283||95.0|-1.1|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.1|0.2283
91672086|NCT00680186|183239160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.2101||95.0|0.26|1.35|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.35|0.26|0.2101
91792858|NCT02751931|183463237|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||||0.006
91637738|NCT03947333|183167477|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.97|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.970
91637739|NCT03947333|183167477|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.786|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.786
91637740|NCT03947333|183167477|OTHER||fixed-effects estimate of intervention|-0.088||||0.67|TWO_SIDED|95.0|-0.493|0.317|||Mixed Models Analysis|||Mixed Effects Model||0.317|-0.493|0.670
91637741|NCT03947333|183167478|SUPERIORITY||Median Difference (Final Values)|0.0||||0.478|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.478
91637742|NCT03947333|183167478|SUPERIORITY||Mean Difference (Net)|-0.2||||0.666|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.666
91637743|NCT03947333|183167478|OTHER||fixed-effects estimate of intervention|-0.15||||0.601|TWO_SIDED|95.0|-0.713|0.413|||Mixed Models Analysis|||Mixed Effects Model||0.413|-0.713|0.601
91637744|NCT03947333|183167479|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.654|TWO_SIDED||||||t-test, 1 sided|||||||0.654
91637745|NCT03947333|183167480|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.485|TWO_SIDED||||||t-test, 1 sided|||||||0.485
91637746|NCT03947333|183167481|OTHER|||||||0.48|||||||McNemar|||||||0.480
91637747|NCT03947333|183167481|OTHER|||||||0.023|||||||McNemar|||||||0.023
91637748|NCT03947333|183167482|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.542|TWO_SIDED||||||t-test, 1 sided|||||||0.542
91637749|NCT02898662|183167488|OTHER|The null hypothesis was that during the 52-week double-blind treatment period, the time to LOAC in the AZD1419 arm was equal to the corresponding time to LOAC in the placebo arm.|Hazard Ratio (HR)|1.05||||0.5722|TWO_SIDED|95.0|0.59|1.87||1-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to LOAC. Cox regression model analysis with age and gender included as covariates.||1.87|0.59|0.5722
91637750|NCT02898662|183167489|OTHER||Odds Ratio (OR)|1.86||||0.2006|TWO_SIDED|95.0|0.72|4.79||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants experiencing LOAC. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment, visit and age and gender as covariates.||4.79|0.72|0.2006
91672087|NCT00680186|183239161|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.2||||0.083||95.0|0.0|0.5|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.5|0.0|0.0830
91672088|NCT00680186|183239162|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.7348||95.0|-0.7|1.0|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.0|-0.7|0.7348
91672089|NCT00680186|183239162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8939||95.0|0.61|1.77|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.77|0.61|0.8939
91672090|NCT00680186|183239163|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.321|TWO_SIDED|95.0|-1.0|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.0|0.3210
91672091|NCT00680186|183239163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.3021|TWO_SIDED|95.0|0.29|1.46|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.29|0.3021
91672092|NCT00680186|183239164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||||95.0|0.36|1.32|||Regression, Cox||This is the analysis of the time to the first MBE.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.32|0.36|
91672093|NCT00680186|183239164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.56|0.81|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.81|0.56|<0.0001
91672094|NCT00479388|183239213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|1.6||0.006||95.0|-7.7|-1.3|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.||||-1.3|-7.7|0.006
91485475|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.9119|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||||||0.9119
91672095|NCT00479388|183239214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|13.4|17.9|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.||||17.9|13.4|<=0.001
91672096|NCT00479388|183239215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<=|0.001||95.0|-19.2|-11.7|||Repeated measures analysis|ANCOVA model based on Tukey's normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.||||-11.7|-19.2|<=0.001
91672097|NCT01876368|183239223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.19|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.73|-1.65|||ANCOVA|||||-1.65|-4.73|<0.001
91672098|NCT02260258|183239244|EQUIVALENCE|Time variable log transformed and compared using linear regression controlling for shock stratification and site. Effect estimate represents geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.0||||0.82|TWO_SIDED|95.0|0.7|1.4||A priori threshold for significance 0.05|Regression, Linear|||||1.4|0.7|0.82
91672099|NCT02260258|183239245|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out all patients (N = 37 in NMB and 43 in Usual Care)|Incidence rate ratio|1.4||||0.09|TWO_SIDED|95.0|1.0|1.9|||Negative binomial regression|||All patients analyzed (N = 37 in NMB and 43 in Usual Care)||1.9|1.0|0.09
91672100|NCT02260258|183239245|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out on ICU survivors alone (n = 14 in NMB and 14 in Control)|Incidence rate ratio|1.3||||0.35|TWO_SIDED|95.0|0.8|2.0|||Negative binomial regression|||ICU survivors alone analyzed (n = 14 in each arm)||2.0|0.8|0.35
91792859|NCT02751931|183463237|OTHER|||||||0.007||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||||0.007
91792860|NCT02751931|183463238|OTHER||Mean Difference (Net)|0.34||||0.018|TWO_SIDED|95.0|0.1|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||0.6|0.1|0.018
91485476|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0826
91485477|NCT01325623|182844032|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0036
91485478|NCT00438451|182844039|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||Fisher Exact|||||||0.0201
91672101|NCT02260258|183239246|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes all patients (n=37 in NMB and n = 43 in control). Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.3||||0.18|TWO_SIDED|95.0|0.9|1.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the full data (n= 37 in NMB and 43 in Control)||1.9|0.9|0.18
91672102|NCT02260258|183239246|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation. Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.4||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the patients surviving to extubation (n= 14 in both groups)||2.9|0.7|0.32
91672103|NCT02260258|183239247|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.3||||0.63|TWO_SIDED|95.0|0.5|3.3|||Regression, Logistic|||||3.3|0.5|0.63
91672104|NCT02260258|183239248|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.7||||0.35|TWO_SIDED|95.0|0.6|4.7|||Regression, Logistic|||||4.7|0.6|0.35
91485479|NCT00438451|182844039|SUPERIORITY_OR_OTHER|||||||0.1536||95.0|||||Fisher Exact|||||||0.1536
91637751|NCT02898662|183167490|OTHER||LS Mean difference|-0.02||||0.8166|TWO_SIDED|95.0|-0.22|0.17||2-sided p-value|Repeated measures analysis|||Comparison between groups for ACQ-5 score. Repeated measures analysis.||0.17|-0.22|0.8166
91637752|NCT02898662|183167491|OTHER||LS Mean difference|-0.03||||0.8412|TWO_SIDED|95.0|-0.32|0.26||2-sided p-value|Repeated measures analysis|||Comparison between groups for asthma daily diary score. Repeated measures analysis.||0.26|-0.32|0.8412
91637753|NCT02898662|183167492|OTHER|The null hypothesis was that the time to moderate or severe exacerbation was not different between AZD1419 and placebo.|Hazard Ratio (HR)|0.8||||0.5477|TWO_SIDED|95.0|0.38|1.67||2-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to moderate or severe asthma exacerbation. Cox regression model analysis with age and gender included as covariates.||1.67|0.38|0.5477
91637754|NCT02898662|183167492|OTHER||Odds Ratio (OR)|0.88||||0.7294|TWO_SIDED|95.0|0.41|1.86||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants with moderate or severe asthma exacerbation. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment and visit as covariates.||1.86|0.41|0.7294
91637755|NCT02898662|183167494|OTHER||LS Mean difference|0.06||||0.3764|TWO_SIDED|95.0|-0.08|0.2||2-sided p-value|Repeated measures analysis|||Comparison between groups for pre-BD FEV1. Repeated measures analysis.||0.20|-0.08|0.3764
91637756|NCT02898662|183167494|OTHER||LS Mean difference|-0.03||||0.7013|TWO_SIDED|95.0|-0.17|0.11||2-sided p-value|Repeated measures analysis|||Comparison between groups for post-BD FEV1. Repeated measures analysis.||0.11|-0.17|0.7013
91637757|NCT02898662|183167495|OTHER||LS Mean difference|-0.32||||0.9686|TWO_SIDED|95.0|-16.54|15.9||2-sided p-value|Repeated measures analysis|||Comparison between groups for PEF. Repeated measures analysis.||15.90|-16.54|0.9686
91637758|NCT02898662|183167496|OTHER||LS Mean difference|-2.02||||0.5403|TWO_SIDED|95.0|-8.55|4.52||2-sided p-value|Repeated measures analysis|||Comparison between groups for FeNO. Repeated measures analysis.||4.52|-8.55|0.5403
91637759|NCT00399542|183167497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||70.6% improvement in response with lubiprostone at 90% statistical power||||0.023
91637760|NCT00399542|183167498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.391|||||||van Elteren nonparametric test|Adjusted for center||||||0.391
91637761|NCT00399542|183167499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|||||||van Elteren nonparametric test|Adjusted for center||||||0.151
91637762|NCT00399542|183167500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|||||||van Elteren nonparametric test|Adjusted for center||||||0.163
91637763|NCT00399542|183167501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|||||||van Elteren nonparametric test|Adjusted for center||||||0.185
91637764|NCT00399542|183167502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Cochran-Mantel-Haenszel|||||||0.300
91637765|NCT00399542|183167503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.303
91637766|NCT00399542|183167504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.047
91637767|NCT00399542|183167505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.008
91637768|NCT00399542|183167506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663|||||||van Elteren nonparametric test|Adjusted for center||||||0.663
91637769|NCT00399542|183167507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224|||||||van Elteren nonparametric test|Adjusted for center||||||0.224
91672105|NCT04230876|183239274|SUPERIORITY||partial eta squared|0.047|||=|0.269|TWO_SIDED|||||Within the 28 participants, changes in the COSI scores after four weeks using the Amptify were compared to the changes after four weeks watching 20 minutes of CC TV (F(1,26)=1.28).|ANOVA|||||||=0.269
91672106|NCT04230876|183239275|SUPERIORITY||partial eta squared|0.031|||=|0.401|TWO_SIDED|||||Changes in the IOI-HA scores measured after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,23)=.733).|ANOVA|||||||=0.401
91485480|NCT00438451|182844039|SUPERIORITY_OR_OTHER|||||||0.3615||95.0|||||Fisher Exact|||||||0.3615
91485481|NCT00438451|182844039|SUPERIORITY_OR_OTHER|||||||0.0478||95.0|||||Fisher Exact|||||||0.0478
91715657|NCT00427908|183322239|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for rSBA-MenA.|Difference in percentage|6.44|||||TWO_SIDED|95.0|1.15|16.04||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.||16.04|1.15|
91792861|NCT02751931|183463238|OTHER||Mean Difference (Net)|0.82||||0.045|TWO_SIDED|95.0|0.0|1.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||1.6|0.0|0.045
91637770|NCT00399542|183167508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.271|||||||van Elteren nonparametric test|Adjusted for center||||||0.271
91637771|NCT00399542|183167509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||van Elteren nonparametric test|Adjusted for center||||||0.945
91637772|NCT00399542|183167510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||van Elteren nonparametric test|||||||0.352
91637773|NCT00399542|183167511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren nonparametric test|Adjusted for center||||||0.180
91637774|NCT00399542|183167512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|||||||van Elteren nonparametric test|Adjusted for center||||||0.275
91637775|NCT00399542|183167513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|||||||van Elteren nonparametric test|Adjusted for center||||||0.722
91637776|NCT00399542|183167514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|||||||van Elteren nonparametric test|Adjusted for center||||||0.177
91637777|NCT00399542|183167515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.082|||||||van Elteren nonparametric test|Adjusted for center||||||0.082
91637778|NCT00399542|183167516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||van Elteren nonparametric test|Adjusted for center||||||0.110
91637779|NCT00399542|183167517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||van Elteren nonparametric test|Adjusted for center||||||0.146
91637780|NCT00399542|183167518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||van Elteren nonparametric test|Adjusted for center||||||0.373
91637781|NCT00399542|183167519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||van Elteren nonparametric test|Adjusted for center||||||0.339
91637782|NCT00399542|183167520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.023
91637783|NCT00399542|183167521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Cochran-Mantel-Haenszel|||||||0.073
91637784|NCT00399542|183167522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|Adjusted for center||||||0.062
91637785|NCT00399542|183167523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||van Elteren nonparametric test|||||||0.060
91637786|NCT00399542|183167524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||van Elteren nonparametric test|||||||0.290
91637787|NCT00399542|183167525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|||||||van Elteren nonparametric test|||||||0.495
91637788|NCT04680273|183167558|OTHER||Geometric mean ratio|0.573|STANDARD_DEVIATION|1.11|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 10.4%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of GDC-9545 in plasma samples compared with the AUC(0-72) of total radioactivity in plasma samples.||||
91637789|NCT04680273|183167558|OTHER||Geometric mean ratio|0.752|STANDARD_DEVIATION|1.036|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 3.5%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of total radioactivity (TR) in whole blood samples compared with the AUC(0-72) of TR in plasma samples.||||
91637790|NCT04680273|183167559|OTHER||Geometric mean ratio|0.625|STANDARD_DEVIATION|1.134|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 12.7%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of GDC-9545 in plasma samples compared with the AUC(0-t) of total radioactivity in plasma samples.||||
91637791|NCT04680273|183167559|OTHER||Geometric mean ratio|0.79|STANDARD_DEVIATION|1.171|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 15.9%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of total radioactivity (TR) in whole blood samples compared with the AUC(0-t) of TR in plasma samples.||||
91637792|NCT01430559|183167589|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||||-0.43|-1.20|<0.0001
91637793|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.0103|TWO_SIDED|95.0|-0.65|-0.09||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 2)||-0.09|-0.65|0.0103
91637794|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0295|TWO_SIDED|95.0|-0.67|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 4)||-0.04|-0.67|0.0295
91637795|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 8)||-0.17|-0.87|0.0041
91637796|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 12)||-0.43|-1.20|<0.0001
91527854|NCT06173570|182930693|SUPERIORITY||Mean Difference (Net)|-7.32||||0.196|TWO_SIDED|95.0|-18.41|3.78|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||3.78|-18.41|0.196
91637797|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.16||0.0369|TWO_SIDED|95.0|-0.64|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 2)||-0.02|-0.64|0.0369
91637798|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2642|TWO_SIDED|95.0|-0.54|0.15||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 4)||0.15|-0.54|0.2642
91637799|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.84|-0.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 8)||-0.10|-0.84|0.0140
91637800|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.2||0.0009|TWO_SIDED|95.0|-1.06|-0.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 12)||-0.28|-1.06|0.0009
91637801|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0017|TWO_SIDED|95.0|-0.72|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 2)||-0.17|-0.72|0.0017
91637802|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0328|TWO_SIDED|95.0|-0.66|-0.03||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 4)||-0.03|-0.66|0.0328
91672107|NCT04230876|183239276|SUPERIORITY||partial eta squared|0.0|||=|0.968|TWO_SIDED|||||Changes in the APHAB benefit scores after four weeks using the Amptify were compared to the improvements seen after four weeks of CC TV every day (F(1,25)=.002).|ANOVA|||||||=0.968
91637803|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0043|TWO_SIDED|95.0|-0.86|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 8)||-0.16|-0.86|0.0043
91637804|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.19|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 12)||-0.43|-1.19|<0.0001
91637805|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.13||0.0051|TWO_SIDED|95.0|-0.65|-0.12||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 2)||-0.12|-0.65|0.0051
91637806|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0593|TWO_SIDED|95.0|-0.61|0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 4)||0.01|-0.61|0.0593
91672108|NCT04230876|183239277|SUPERIORITY||partial eta squared|0.028|||=|0.392|TWO_SIDED|||||Changes in the SSQ-12 scores after four weeks using the Amptify were compared to the improvements seen after four weeks watching 20 minutes of CC TV (F(1,26)=.756).|ANOVA|||||||=0.392
91637807|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.84|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 8)||-0.16|-0.84|0.0046
91637808|NCT01430559|183167590|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.14|-0.39||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 12)||-0.39|-1.14|<0.0001
91672109|NCT04230876|183239278|SUPERIORITY||partial eta squared|0.005|||=|0.72|TWO_SIDED|||||Among the 28 participants, changes in the hours per day of hearing aid usage seen after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,26)=.131).|ANOVA|||||||=0.720
91672110|NCT04230876|183239279|SUPERIORITY||partial eta squared|0.052|||=|0.242|TWO_SIDED|||||Changes in the NU-6 seen after four weeks using the Amptify were compared to the changes seen after four weeks watching 20 minutes of CC TV (F(1,26)=1.43).|ANOVA|||||||=0.242
91672111|NCT00545688|183239281|SUPERIORITY_OR_OTHER||Difference in Response rates|16.82||||0.0094|TWO_SIDED|95.0|3.5|30.1||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||30.1|3.5|0.0094
91672112|NCT00545688|183239281|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0141
91637809|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.94|-0.3||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 2)||-0.30|-0.94|0.0002
91637810|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.92|-0.22||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 4)||-0.22|-0.92|0.0015
91637811|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0003|TWO_SIDED|95.0|-1.08|-0.32||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 8)||-0.32|-1.08|0.0003
91637812|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.34|-0.51||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 12)||-0.51|-1.34|<0.0001
91672113|NCT00545688|183239281|SUPERIORITY_OR_OTHER||Difference in Response rates|-12.15||||0.0198|TWO_SIDED|95.0|-23.8|-0.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-0.5|-23.8|0.0198
91672114|NCT00545688|183239281|SUPERIORITY_OR_OTHER|||||||0.0198|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0198
91672115|NCT00545688|183239281|SUPERIORITY_OR_OTHER||Difference in Response rates|-21.84||||0.001|TWO_SIDED|95.0|-35.1|-8.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-8.5|-35.1|0.0010
91672116|NCT00545688|183239281|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0030
91672117|NCT00545688|183239296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.2983|TWO_SIDED|95.0|0.34|1.4|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||1.40|0.34|0.2983
91672118|NCT00545688|183239296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4722|TWO_SIDED|95.0|0.68|2.3|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||2.30|0.68|0.4722
91672119|NCT00545688|183239296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.05||||0.0268|TWO_SIDED|95.0|1.07|3.93|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||3.93|1.07|0.0268
91672120|NCT00545688|183239296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1805|TWO_SIDED|95.0|0.28|1.27|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.27|0.28|0.1805
91672121|NCT00545688|183239296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5901|TWO_SIDED|95.0|0.42|1.64|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.64|0.42|0.5901
91672122|NCT00545688|183239296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.025|TWO_SIDED|95.0|1.08|4.32|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||4.32|1.08|0.0250
91672123|NCT04243096|183239298|OTHER||Mean Difference (Final Values)|4.62|||<|0.0001|TWO_SIDED|95.0|2.6|6.64|||Mixed Models Analysis|||||6.64|2.60|<0.0001
91637813|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.0363|TWO_SIDED|95.0|-0.67|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 2)||-0.02|-0.67|0.0363
91637814|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.0311|TWO_SIDED|95.0|-0.75|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 4)||-0.04|-0.75|0.0311
91637815|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0057|TWO_SIDED|95.0|-0.94|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 8)||-0.16|-0.94|0.0057
91672124|NCT04243096|183239299|OTHER||Mean Difference (Final Values)|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Mixed Models Analysis|||||-0.02|-0.06|<0.0001
91672125|NCT04243096|183239300|OTHER||Mean Difference (Final Values)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.01|||Mixed Models Analysis|||||-0.01|-0.03|<0.0001
91672126|NCT04243096|183239301|OTHER||Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.04|-0.02|||Mixed Models Analysis|||||-0.02|-0.04|<0.0001
91672127|NCT04243096|183239302|OTHER||Mean Difference (Final Values)|-0.01|||<|0.0001|TWO_SIDED|95.0|-0.01|0.0|||Mixed Models Analysis|||||0.00|-0.01|<0.0001
91672128|NCT04243096|183239303|OTHER||Mean Difference (Final Values)|-0.01||||0.0013|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0013
91672129|NCT04243096|183239304|OTHER||Mean Difference (Final Values)|-0.02||||0.0003|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0003
91672130|NCT04243096|183239305|OTHER||Mean Difference (Final Values)|0.03|||<|0.0001|TWO_SIDED|95.0|0.02|0.04|||Mixed Models Analysis|||||0.04|0.02|<0.0001
91672131|NCT04243096|183239306|OTHER||Mean Difference (Final Values)|0.09|||<|0.0001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|||||0.13|0.06|<0.0001
91672132|NCT04243096|183239310|OTHER||Mean Difference (Final Values)|9.96|||<|0.0001|TWO_SIDED|95.0|6.6|13.31|||Mixed Models Analysis|||||13.31|6.60|<0.0001
91672133|NCT04243096|183239311|OTHER||Mean Difference (Final Values)|13.07|||<|0.0001|TWO_SIDED|95.0|9.65|16.48|||Mixed Models Analysis|adjusted for age, sex, BMI, and presence of comorbidities.|Change from baseline to week 12|||16.48|9.65|<0.0001
91672134|NCT04243096|183239312|OTHER||Median Difference (Final Values)|-17.5||||0.1196|TWO_SIDED|95.0|-39.7|4.61|||Mixed Models Analysis|||||4.61|-39.7|0.1196
91672135|NCT04243096|183239314|OTHER||Mean Difference (Final Values)|0.11|||<|0.0001|TWO_SIDED|95.0|-0.04|0.25|||Mixed Models Analysis|||||0.25|-0.04|<0.0001
91672136|NCT04243096|183239315|OTHER||Mean Difference (Final Values)|-1.83|||<|0.0001|TWO_SIDED|95.0|-5.76|2.09|||Mixed Models Analysis|||||2.09|-5.76|<0.0001
91672137|NCT04243096|183239316|OTHER||Mean Difference (Final Values)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.46|0.16|||Mixed Models Analysis|||||0.16|-0.46|<0.0001
91672138|NCT04243096|183239317|OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-2.22|-0.08|||Mixed Models Analysis|||||-0.08|-2.22|<0.0001
91672139|NCT04243096|183239318|OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001|TWO_SIDED|95.0|-3.37|3.22|||Mixed Models Analysis|||||3.22|-3.37|<0.0001
91672140|NCT04243096|183239319|OTHER||Mean Difference (Final Values)|6.21||||0.0134|TWO_SIDED|95.0|1.31|11.11|||Mixed Models Analysis|||||11.11|1.31|0.0134
91672141|NCT04243096|183239320|OTHER||Median Difference (Final Values)|1.75|||<|0.0001|TWO_SIDED|95.0|1.16|2.34|||Mixed Models Analysis|||||2.34|1.16|<0.0001
91672142|NCT04243096|183239321|OTHER||Median Difference (Final Values)|-1.19||||0.003|TWO_SIDED|95.0|-1.97|-0.41|||Mixed Models Analysis|||||-0.41|-1.97|0.0030
91672143|NCT04243096|183239322|OTHER||Mean Difference (Final Values)|0.45|||<|0.0001|TWO_SIDED|95.0|0.23|0.67|||Mixed Models Analysis|||||0.67|0.23|<0.0001
91672144|NCT04243096|183239323|OTHER||Mean Difference (Final Values)|35.18|||<|0.0001|TWO_SIDED|95.0|18.7|51.67|||Mixed Models Analysis|||||51.67|18.70|<0.0001
91672145|NCT04243096|183239324|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.57|-1.39|||Mixed Models Analysis|||||-1.39|-2.57|<0.0001
91672146|NCT02792218|183239340|SUPERIORITY||rate ratio|0.495|||<|0.001|TWO_SIDED|95.0|0.375|0.655|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.655|0.375|<0.001
91526400|NCT00744263|182927965|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.56||||0.0006|TWO_SIDED|95.2|21.82|62.49|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||62.49|21.82|0.0006
91672147|NCT02792218|183239341|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.863|0.500|0.003
91672148|NCT02792218|183239342|SUPERIORITY||Hazard Ratio (HR)|0.652||||0.029|TWO_SIDED|95.0|0.445|0.956|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.956|0.445|0.029
91672149|NCT02792218|183239343|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.917|0.498|0.012
91672150|NCT02792218|183239344|SUPERIORITY||Hazard Ratio (HR)|0.607||||0.022|TWO_SIDED|95.0|0.396|0.93|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.930|0.396|0.022
91672151|NCT02792218|183239345|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.952|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.952|0.952|0.092
91672152|NCT02792218|183239346|SUPERIORITY||Hazard Ratio (HR)|1.186||||0.516|TWO_SIDED|95.0|0.709|1.983|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.983|0.709|0.516
91672153|NCT02792218|183239347|SUPERIORITY||rate ratio|0.025|||<|0.001|TWO_SIDED|95.0|0.013|0.049|||negative binomial regression model|||||0.049|0.013|<.001
91672154|NCT02792218|183239348|SUPERIORITY||rate ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.21|0.33|||negative binomial regression model|||Month 12||0.33|0.21|<.001
91672155|NCT02792218|183239348|SUPERIORITY||rate ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.34|||negative binomial regression model|||Month 24||0.34|0.15|<.001
91672156|NCT02792218|183239348|SUPERIORITY||rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.22|||negative binomial regression model|||End of Study||0.22|0.15|<.001
91672157|NCT02792218|183239349|SUPERIORITY||Geo-mean ratio|0.93||||0.011|TWO_SIDED|95.0|0.89|0.98|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.98|0.89|0.011
91672158|NCT02792218|183239349|SUPERIORITY||Geo-mean ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.69|0.77|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.77|0.69|<.001
91672159|NCT02792218|183239349|SUPERIORITY||Geo-mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.72|0.82|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.82|0.72|<.001
91672160|NCT02792218|183239350|SUPERIORITY||Mean Difference (Net)|0.07||||0.118|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.118
91672161|NCT02792218|183239353|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||||0.847|0.486|0.002
91672162|NCT02792218|183239354|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||||0.898|0.481|0.008
91672163|NCT00248170|183239370|SUPERIORITY_OR_OTHER|||||||0.315|||||||Log Rank|||||||0.3150
91672164|NCT01557582|183239385|SUPERIORITY_OR_OTHER||EDV percent difference|4.8|||||TWO_SIDED|95.0|2.24|7.56|||||Mean percent difference and 95% CI for EDV|||7.56|2.24|
91637816|NCT01430559|183167591|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.52|-0.64||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 12)||-0.64|-1.52|<0.0001
91637817|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.2373|TWO_SIDED|95.0|0.79|2.55||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 2)||2.55|0.79|0.2373
91637818|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2069|TWO_SIDED|95.0|0.84|2.26||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 4)||2.26|0.84|0.2069
91637819|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.068|TWO_SIDED|95.0|0.97|2.53||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 8)||2.53|0.97|0.0680
91637820|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.41||||0.0005|TWO_SIDED|95.0|1.47|3.94||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 12)||3.94|1.47|0.0005
91672165|NCT01557582|183239385|SUPERIORITY_OR_OTHER||ESV percent difference|1.76|||||TWO_SIDED|95.0|-1.17|4.76|||||Mean percent difference and 95% CI for ESV|||4.76|-1.17|
91672166|NCT01557582|183239385|SUPERIORITY_OR_OTHER||EF percent difference|2.03|||||TWO_SIDED|95.0|0.72|3.33|||||Mean percent difference and 95% CI for EF|||3.33|0.72|
91672167|NCT00749411|183239401|NON_INFERIORITY|GSK233705/GW642444 were declared non-inferior to placebo for heart rate if the upper limit of the 95% confidence interval for the estimated treatment difference for weighted mean heart rate was less than +10bpm.|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-5.5|3.5|||||Analysis performed using a Repeated Measures Model with covariates of baseline pulse rate, sex, age, smoking status, treatment and Day and Day by treatment and Day by baseline interactions.|||3.5|-5.5|
91672168|NCT03694808|183239403|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|ratio of GMT (Fluzone/Fluad)|1.23|||||TWO_SIDED|95.0|0.8|1.89|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||1.89|0.8|
91672169|NCT03694808|183239403|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.95|||||TWO_SIDED|95.0|0.66|1.38|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.38|0.66|
91637821|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.94||||0.1736|TWO_SIDED|95.0|0.75|5.01||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 2)||5.01|0.75|0.1736
91637822|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1496|TWO_SIDED|95.0|0.82|3.59||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 4)||3.59|0.82|0.1496
91672170|NCT03694808|183239404|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.38|||||TWO_SIDED|95.0|0.88|2.15|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||2.15|0.88|
91672171|NCT03694808|183239404|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.86|||||TWO_SIDED|95.0|0.53|1.4|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.4|0.53|
91637823|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12||||0.0171|TWO_SIDED|95.0|1.14|3.93||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 8)||3.93|1.14|0.0171
91637824|NCT01430559|183167593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77||||0.0004|TWO_SIDED|95.0|1.57|4.89||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 12)||4.89|1.57|0.0004
91637825|NCT01430559|183167594|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0027|TWO_SIDED|95.0|-0.31|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.07|-0.31|0.0027
91637826|NCT01430559|183167594|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|-0.3|-0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||-0.01|-0.30|0.0308
91672172|NCT03694808|183239405|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.85|||||TWO_SIDED|95.0|1.23|2.79|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||2.79|1.23|
91672173|NCT03694808|183239405|NON_INFERIORITY|2-sided t-test performed on log-transformed titers; estimate and 95% confidence interval of log-scale difference exponentiated to generate GMT ratio and its 95% CI below.|Ratio of GMT (Fluzone/Fluad)|0.88|||||TWO_SIDED|95.0|0.61|1.26|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.26|0.61|
91792862|NCT02751931|183463238|OTHER||Mean Difference (Net)|0.68||||0.013|TWO_SIDED|95.0|0.1|1.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||1.2|0.1|0.013
91672174|NCT03694808|183239406|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.154|||||TWO_SIDED|95.0|-0.001|0.308|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.308|-0.001|
91637827|NCT01430559|183167594|SUPERIORITY_OR_OTHER_LEGACY|P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Week 8||-0.05|-0.31|0.0060
91637828|NCT01430559|183167594|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.34|-0.05||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.05|-0.34|0.0076
91637829|NCT01430559|183167595|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.2843|TWO_SIDED|95.0|0.53|8.5||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 2||8.50|0.53|0.2843
91637830|NCT01430559|183167595|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.05||||0.105|TWO_SIDED|95.0|0.86|4.87||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 4||4.87|0.86|0.1050
91637831|NCT01430559|183167595|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.7861|TWO_SIDED|95.0|0.4|3.32||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 8||3.32|0.40|0.7861
91637832|NCT01430559|183167595|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.1873|TWO_SIDED|95.0|0.77|3.78||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 12||3.78|0.77|0.1873
91637833|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|1.55||0.3738|TWO_SIDED|95.0|-1.67|4.42||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||General health||4.42|-1.67|0.3738
91637834|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.94|STANDARD_ERROR_OF_MEAN|1.96||0.0028|TWO_SIDED|95.0|2.07|9.8||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical functioning||9.80|2.07|0.0028
91637835|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|2.14||0.0002|TWO_SIDED|95.0|3.95|12.38||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role physical||12.38|3.95|0.0002
91637836|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|7.36|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|4.1|10.63||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Bodily pain||10.63|4.10|<0.0001
91672175|NCT03694808|183239406|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.056|||||TWO_SIDED|95.0|-0.2|0.089|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.089|-0.2|
91637837|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|1.64||0.2124|TWO_SIDED|95.0|-1.18|5.27||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Vitality||5.27|-1.18|0.2124
91637838|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.96|STANDARD_ERROR_OF_MEAN|2.1||0.005|TWO_SIDED|95.0|1.82|10.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Social functioning||10.10|1.82|0.0050
91637839|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.87|STANDARD_ERROR_OF_MEAN|2.24||0.0093|TWO_SIDED|95.0|1.46|10.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role emotional||10.28|1.46|0.0093
91637840|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|1.64||0.7274|TWO_SIDED|95.0|-2.66|3.81||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental health||3.81|-2.66|0.7274
91792863|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.36||||0.002|TWO_SIDED|95.0|0.6|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||2.2|0.6|0.002
91637841|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.88||0.2819|TWO_SIDED|95.0|-0.78|2.67||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental component aggregate||2.67|-0.78|0.2819
91637842|NCT01430559|183167596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|0.66||0.0001|TWO_SIDED|95.0|1.27|3.86||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical component aggregate||3.86|1.27|0.0001
91715658|NCT00427908|183322239|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenC.|Difference in percentage|13.18|||||TWO_SIDED|95.0|4.79|24.32||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.||24.32|4.79|
91715659|NCT00427908|183322239|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenW-135.|Difference in percentage|4.41|||||TWO_SIDED|95.0|1.51|12.21||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.||12.21|1.51|
91715660|NCT00427908|183322239|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrux minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenY.|Difference in percentage|16.23|||||TWO_SIDED|95.0|8.99|26.78||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.||26.78|8.99|
91792864|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.14||||0.001|TWO_SIDED|95.0|0.5|1.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||1.8|0.5|0.001
91637843|NCT01430559|183167597|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6||||0.0014|TWO_SIDED|95.0|1.45|4.66||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Mobility||4.66|1.45|0.0014
91637844|NCT01430559|183167597|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.108|TWO_SIDED|95.0|0.91|2.48||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Self-care||2.48|0.91|0.1080
91637845|NCT01430559|183167597|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.0119|TWO_SIDED|95.0|1.17|3.62||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Usual activities||3.62|1.17|0.0119
91637846|NCT01430559|183167597|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0887|TWO_SIDED|95.0|0.93|2.83||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Pain/discomfort||2.83|0.93|0.0887
91637847|NCT01430559|183167597|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2466|TWO_SIDED|95.0|0.8|2.33||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Anxiety/depression||2.33|0.80|0.2466
91637848|NCT01430559|183167598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0367|TWO_SIDED|95.0|-0.58|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.02|-0.58|0.0367
91637849|NCT01430559|183167598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0652|TWO_SIDED|95.0|-0.65|0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||0.02|-0.65|0.0652
91637850|NCT01430559|183167598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.19||0.02|TWO_SIDED|95.0|-0.81|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 8||-0.07|-0.81|0.0200
91637851|NCT01430559|183167598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0016|TWO_SIDED|95.0|-1.02|-0.24||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.24|-1.02|0.0016
91637852|NCT00174460|183167609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.991|STANDARD_ERROR_OF_MEAN|0.1067|<|0.001|TWO_SIDED|95.0|0.773|1.21|||ANCOVA|Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).||Treatment difference||1.210|0.773|<0.001
91637853|NCT00174460|183167610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.415|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|3.605|5.225|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.225|3.605|<0.001
91672176|NCT03694808|183239407|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.218|||||TWO_SIDED|95.0|0.063|0.373|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.373|0.063|
91672177|NCT03694808|183239407|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.008|||||TWO_SIDED|95.0|-0.139|0.123|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.123|-0.139|
91672178|NCT03694808|183239408|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.136|||||TWO_SIDED|95.0|-0.019|0.291|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.291|-0.019|
91672179|NCT03694808|183239408|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.024|||||TWO_SIDED|95.0|-0.117|0.164|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.164|-0.117|
91672180|NCT03694808|183239409|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.43|||||TWO_SIDED|95.0|0.29|0.64|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||0.64|0.29|
91672181|NCT03694808|183239409|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||0.69|0.29|
91672182|NCT03694808|183239410|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.91|||||TWO_SIDED|95.0|0.71|1.16|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||1.16|0.71|
91672183|NCT03694808|183239410|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.96|||||TWO_SIDED|95.0|0.69|1.33|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.33|0.69|
91672184|NCT03694808|183239411|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.544|||||TWO_SIDED|95.0|-0.674|-0.414|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||-0.414|-0.674|
91672185|NCT03694808|183239411|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.168|||||TWO_SIDED|95.0|-0.311|-0.025|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||-0.025|-0.311|
91672186|NCT03694808|183239412|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.104|||||TWO_SIDED|95.0|-0.221|0.013|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.013|-0.221|
91672187|NCT03694808|183239412|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference of proportions|-0.113|||||TWO_SIDED|95.0|-0.241|0.015|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.015|-0.241|
91672188|NCT00455962|183239419|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Using previously collected data from a group of 18 predominantly Caucasian women undergoing a similar infusion we determined that 22 women would be necessary to identify a 30% difference in peak LH levels, the primary outcome measure, between AAW and CW with 80% power at a significance level of 0.05.||||0.69
91672189|NCT02070757|183239420|NON_INFERIORITY|Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-5.13|7.39|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||7.39|-5.13|
91672190|NCT02070757|183239421|NON_INFERIORITY|Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.|Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-6.17|8.29|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||8.29|-6.17|
91672191|NCT02070757|183239422|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|4.4|||||TWO_SIDED|95.0|-2.83|11.75|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||11.75|-2.83|
91792865|NCT02751931|183463238|OTHER||Mean Difference (Net)|2.26|||<|0.001|TWO_SIDED|95.0|1.2|3.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||3.3|1.2|<0.001
91792866|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.31||||0.001|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||2.1|0.5|0.001
91637854|NCT00174460|183167610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|0.5327||0.108|TWO_SIDED|95.0|-1.977|0.208|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.208|-1.977|0.108
91637855|NCT00174460|183167611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.074|STANDARD_ERROR_OF_MEAN|0.7089||0.141|TWO_SIDED|95.0|-2.524|0.376|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||0.376|-2.524|0.141
91637856|NCT00174460|183167612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_ERROR_OF_MEAN|0.3661|<|0.001|TWO_SIDED|95.0|3.789|5.291|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.291|3.789|<0.001
91637857|NCT00174460|183167612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.064|STANDARD_ERROR_OF_MEAN|0.9822|<|0.001|TWO_SIDED|95.0|2.049|6.08|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||6.080|2.049|<0.001
91637858|NCT00174460|183167613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719|STANDARD_ERROR_OF_MEAN|0.1606|<|0.001|TWO_SIDED|95.0|0.39|1.047|||ANCOVA|Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.||Treatment difference Month 24||1.047|0.390|<0.001
91637859|NCT00174460|183167614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.497|<|0.001|TWO_SIDED|95.0|-3.73|-1.68|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 12||-1.68|-3.73|<0.001
91637860|NCT00174460|183167614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.758||0.537|TWO_SIDED|95.0|-2.04|1.09|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 24||1.09|-2.04|0.537
91792867|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.93|||<|0.001|TWO_SIDED|95.0|0.9|3.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||3.0|0.9|<0.001
91792868|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.34|||<|0.001|TWO_SIDED|95.0|0.7|2.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||2.0|0.7|<0.001
91637861|NCT00174460|183167615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.405||0.364|TWO_SIDED|95.0|-1.21|0.46|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||0.46|-1.21|0.364
91637862|NCT00174460|183167615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.345||0.506|TWO_SIDED|95.0|-0.94|0.48|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.48|-0.94|0.506
91637863|NCT00174460|183167616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|1.188||0.959|TWO_SIDED|95.0|-2.42|2.54|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||2.54|-2.42|0.959
91637864|NCT00174460|183167616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.065||0.919|TWO_SIDED|95.0|-2.11|2.32|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||2.32|-2.11|0.919
91637865|NCT00174460|183167617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.8161||0.336|TWO_SIDED|95.0|-3.158|1.374|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 12||1.374|-3.158|0.336
91637866|NCT00174460|183167617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.717|STANDARD_ERROR_OF_MEAN|0.6027||0.3|TWO_SIDED|95.0|-0.956|2.391|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 24||2.391|-0.956|0.300
91637867|NCT00174460|183167618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.615|STANDARD_ERROR_OF_MEAN|0.6591|<|0.001|TWO_SIDED|95.0|4.266|6.963|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||6.963|4.266|<0.001
91637868|NCT00174460|183167619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.482|STANDARD_ERROR_OF_MEAN|0.9666||0.653|TWO_SIDED|95.0|-3.558|2.595|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||2.595|-3.558|0.653
91637869|NCT00174460|183167619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.205|STANDARD_ERROR_OF_MEAN|0.8991||0.251|TWO_SIDED|95.0|-3.701|1.292|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.292|-3.701|0.251
91637870|NCT00174460|183167620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|1.1499||0.914|TWO_SIDED|95.0|-3.524|3.795|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.795|-3.524|0.914
91792869|NCT02751931|183463238|OTHER||Mean Difference (Net)|2.17|||<|0.001|TWO_SIDED|95.0|1.2|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||3.2|1.2|<0.001
91792870|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.33||||0.002|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||2.1|0.5|0.002
91792871|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.88|||<|0.001|TWO_SIDED|95.0|1.0|2.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||2.8|1.0|<0.001
91637871|NCT00174460|183167620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.4432||0.547|TWO_SIDED|95.0|-0.939|1.522|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.522|-0.939|0.547
91715661|NCT00427908|183322242|NON_INFERIORITY|Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Meningitec Group) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the predefined clinical limit of -15%.|Difference in vaccine response rate|1.47|||||TWO_SIDED|95.0|-0.27|7.89||||||To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.||7.89|-0.27|
91715662|NCT01764841|183322333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7331||||0.065|TWO_SIDED|97.5|0.5027|1.069|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.0690|0.5027|0.0650
91715663|NCT01764841|183322333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5333||||0.0005|TWO_SIDED|97.5|0.3568|0.7971|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||0.7971|0.3568|0.0005
91715664|NCT01764841|183322334|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8615||||0.2944|TWO_SIDED|97.5|0.6264|1.1848|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 28 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.1848|0.6264|0.2944
91715665|NCT01764841|183322334|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.7329||||0.0382|TWO_SIDED|97.5|0.5237|1.0256|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 14 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.0256|0.5237|0.0382
91715666|NCT04863872|183322350|OTHER|Difference|Risk Ratio (RR)|0.72||||0.27|TWO_SIDED|95.0|0.39|1.3|||Poisson regression|Poisson regression with binary primary outcome, estimated using Generalized Estimating Equations (GEE) and robust variance estimation.||||1.30|0.39|0.27
91715667|NCT00549549|183322351|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||-0.18|-0.74|
91715668|NCT00549549|183322351|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||||0.04|-0.52|
91715669|NCT00549549|183322351|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||||0.84|0.29|
91715670|NCT00549549|183322351|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||||0.60|0.05|
91637872|NCT00174460|183167621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.4542||0.007|TWO_SIDED|95.0|1.049|3.572|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.572|1.049|0.007
91637873|NCT00174460|183167621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.626|STANDARD_ERROR_OF_MEAN|0.6536||0.068|TWO_SIDED|95.0|-0.189|3.44|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||3.440|-0.189|0.068
91637874|NCT00174460|183167624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.5061||0.331|TWO_SIDED|95.0|-0.846|1.965|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 12||1.965|-0.846|0.331
91637875|NCT00174460|183167624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.4703||0.82|TWO_SIDED|95.0|-1.192|1.42|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 24||1.420|-1.192|0.820
91715671|NCT00549549|183322351|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||||0.39|-0.17|
91715672|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.29|0.14|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.14|-0.29|
91715673|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.42|0.02|||ANCOVA|||Day 5 analysis||0.02|-0.42|
91715674|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.04|0.47|||ANCOVA|||Day 5 analysis||0.47|0.04|
91715675|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.04|0.39|||ANCOVA|||Day 5 analysis||0.39|-0.04|
91715676|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 5 analysis||0.27|-0.16|
91715677|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Day 9 analysis||0.16|-0.26|
91715678|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Day 9 analysis||0.03|-0.40|
91715679|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.32|||ANCOVA|||Day 9 analysis||0.32|-0.11|
91715680|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 9 analysis||0.27|-0.16|
91715681|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||Day 9 analysis||0.13|-0.30|
91672192|NCT02070757|183239423|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.3|||||TWO_SIDED|95.0|-10.21|7.67|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||7.67|-10.21|
91672193|NCT02070757|183239424|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|7.0||||||95.0|-5.11|18.93|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||18.93|-5.11|
91672194|NCT02070757|183239426|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.4|||||TWO_SIDED|95.0|-6.41|3.57|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||3.57|-6.41|
91672195|NCT02070757|183239427|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-0.8|||||TWO_SIDED|95.0|-7.67|6.04|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||6.04|-7.67|
91672196|NCT02070757|183239428|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|1.6|||||TWO_SIDED|95.0|-8.91|12.02|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||12.02|-8.91|
91672197|NCT02070757|183239429|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|3.3|||||TWO_SIDED|95.0|-3.38|10.44|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||10.44|-3.38|
91672198|NCT01332578|183239447|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.92||||0.0004|TWO_SIDED|95.0|-27.31|-15.81|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of median difference was determined.|Null hypothesis was no difference between test hot drink and standard paracetamol tablets.||-15.81|-27.31|0.0004
91672199|NCT02597582|183239457|NON_INFERIORITY_OR_EQUIVALENCE|"A previous study found that the mean operation time was 165 minutes for patients undergoing LigaSure vessel sealing system-assisted total laryngectomy plus neck dissection and 195 minutes for those receiving conventional hemostasis.~With a difference in operative duration of 30 minutes between the two groups,9 the estimated sample size needed to demonstrate a two-sided significance level of 0.05 with 80% power should be at least 18 participants in each treatment arm."||||||0.022|||||||t-test, 2 sided|||||||0.022
91672200|NCT02597582|183239458|NON_INFERIORITY_OR_EQUIVALENCE|As above||||||0.266|||||||t-test, 2 sided|||||||0.266
91672201|NCT02597582|183239459|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.06|||||||t-test, 2 sided|||||||0.060
91526401|NCT00744263|182927966|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.0||||0.0067|TWO_SIDED|95.2|14.21|65.31|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||65.31|14.21|0.0067
91672202|NCT02597582|183239461|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.524|||||||t-test, 2 sided|||||||0.524
91672203|NCT02597582|183239462|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
91672204|NCT01833533|183239484|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
91672205|NCT01833533|183239484|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
91672206|NCT01833533|183239485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91672207|NCT01833533|183239486|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
91672208|NCT01833533|183239486|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
91672209|NCT01833533|183239486|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|-6.8|||||TWO_SIDED|95.0|-12.0|-1.5|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).||-1.5|-12.0|
91672210|NCT01043926|183239572|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Moderate Hepatic Insufficiency Participants ÷ AUC(0-∞) GM for Healthy Participants~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the AUC(0-∞) GMR fell below 2.00, then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.74|1.43|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.43|0.74|
91672211|NCT01043926|183239573|NON_INFERIORITY_OR_EQUIVALENCE|"Cmax GMR = Cmax GM for Moderate Hepatic Insufficiency Participants ÷ Cmax GM for Healthy Participants~A 90% CI for the Cmax GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the Cmax GMR fell below 2.00, then the hypothesis would be met and the Cmax of suvorexant would be similar in both groups of participants. That is, if the true ratio of the geometric mean Cmax is no more than 2.00."|Cmax Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.68|1.29|||ANCOVA|||"The GM for each participant group and the corresponding 95% CI were calculated for Cmax using an ANCOVA model.~The Cmax GMR of the 2 participant groups was used to test the primary hypothesis, which was that the Cmax of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.29|0.68|
91672212|NCT00562120|183239662|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED|||||P-value was based on one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.302
91672213|NCT00562120|183239662|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
91485482|NCT00438451|182844039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.838||||0.0578|TWO_SIDED|95.0|1.092|3.093|||Regression, Logistic|adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)|"Odds ratio given here is for comparison LEV vs CBZ: OR=1.838 KI=(1.092-3.093) LEV vs LTG: OR=1.169 KI=(0.689-1.984) CBZ vs LTG: OR=0.636 KI=(0.377-1.073) Number of concurrent diseases: OR=0.921 KI=(0.859-0.987)"|||3.093|1.092|0.0578
91485483|NCT00438451|182844040|SUPERIORITY_OR_OTHER|||||||0.0596||95.0|||||Log Rank|||||||0.0596
91672214|NCT00562120|183239662|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.229
91672215|NCT00562120|183239662|SUPERIORITY_OR_OTHER|||||||0.544|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.544
91715682|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.33|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.33|
91485484|NCT00438451|182844041|SUPERIORITY_OR_OTHER|||||||0.2517||95.0|||||Fisher Exact|||||||0.2517
91485485|NCT00438451|182844042|SUPERIORITY_OR_OTHER|||||||0.3303||95.0|||||Fisher Exact|||||||0.3303
91485486|NCT00438451|182844043|SUPERIORITY_OR_OTHER|||||||0.5022||95.0|||||Log Rank|||||||0.5022
91637876|NCT00174460|183167625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.844|TWO_SIDED|95.0|-0.88|1.05|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 12||1.05|-0.88|0.844
91672216|NCT00562120|183239662|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.710
91672217|NCT00562120|183239662|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.816
91637877|NCT00174460|183167625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.329||0.519|TWO_SIDED|95.0|-0.52|0.96|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 24||0.96|-0.52|0.519
91637878|NCT00174460|183167628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.998|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.778|1.219|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||1.219|0.778|<0.001
91637879|NCT00174460|183167628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.688|STANDARD_ERROR_OF_MEAN|0.1519|<|0.001|TWO_SIDED|95.0|0.382|0.994|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||0.994|0.382|<0.001
91637880|NCT00174460|183167630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.585|STANDARD_ERROR_OF_MEAN|0.3859|<|0.001|TWO_SIDED|95.0|3.806|5.363|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||5.363|3.806|<0.001
91637881|NCT00174460|183167630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.563|STANDARD_ERROR_OF_MEAN|0.708|<|0.001|TWO_SIDED|95.0|2.134|4.992|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||4.992|2.134|<0.001
91637882|NCT04652245|183167637|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
91637883|NCT04652245|183167638|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
91637884|NCT01288911|183167656|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.57|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.||0.57|0.34|<0.0001
91637885|NCT01288911|183167657|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.55|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.||0.55|0.33|<0.0001
91637886|NCT01288911|183167658|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
91637887|NCT01288911|183167659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||Best PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
91637888|NCT01288911|183167660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.39|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA progression Enzalutamide Vs. Bicalutamide.||0.39|0.20|<0.0001
91672218|NCT00562120|183239663|SUPERIORITY_OR_OTHER|||||||0.269|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.269
91672219|NCT00562120|183239663|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.097
91637889|NCT01288911|183167661|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.07|||<|0.0001|TWO_SIDED|95.0|3.18|8.09|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA Enzalutamide Vs. Bicalutamide.||8.09|3.18|<0.0001
91637890|NCT01288911|183167662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.55|||<|0.0001|TWO_SIDED|95.0|3.96|7.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 30% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||7.79|3.96|<0.0001
91637891|NCT01288911|183167663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.01|||<|0.0001|TWO_SIDED|95.0|4.83|10.16|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 50% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||10.16|4.83|<0.0001
91637892|NCT01288911|183167664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|13.91|||<|0.0001|TWO_SIDED|95.0|7.23|26.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 90% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||26.79|7.23|<0.0001
91637893|NCT01288911|183167665|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.36|0.74|||Log Rank||Estimated by use of Cox proportional hazards model.|Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.||0.74|0.36|0.0002
91637894|NCT02543918|183167668|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|90.0|-16.6|19.2||||||Tetanus vaccine responders||19.2|-16.6|
91637895|NCT02543918|183167668|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|90.0|-12.9|11.0||||||Pneumococcal vaccine responders||11.0|-12.9|
91637896|NCT03503617|183167669|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91792872|NCT02751931|183463238|OTHER||Mean Difference (Net)|1.38||||0.002|TWO_SIDED|95.0|0.5|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||2.2|0.5|0.002
91792873|NCT02751931|183463238|OTHER||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|95.0|1.1|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||3.2|1.1|<0.001
91792874|NCT02751931|183463239|OTHER||Mean Difference (Net)|2.04||||0.352|TWO_SIDED|95.0|-2.4|6.49||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||6.49|-2.40|0.352
91637897|NCT05489146|183167677|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|||||||0.046
91637898|NCT05489146|183167678|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
91637899|NCT05489146|183167679|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91637900|NCT05489146|183167680|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91637901|NCT05489146|183167681|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91637902|NCT05489146|183167682|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91637903|NCT05489146|183167683|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91637904|NCT05489146|183167684|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
91637905|NCT02452892|183167697|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.307||||||"P-value displayed for 60min.~Mixed Model Repeated Measures (MMRM) model."|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.307
91637906|NCT02452892|183167697|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.859||||||P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.859
91637907|NCT02452892|183167698|SUPERIORITY|||||||0.966||||||P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 2 baseline HAM-D6 total score, treatment, visit, treatment\*visit, age, \& gender included in model. Visit was the repeated measure within subject.||||||0.966
91792875|NCT02751931|183463239|OTHER||Mean Difference (Net)|-4.9||||0.127|TWO_SIDED|95.0|-11.34|1.53||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.53|-11.34|0.127
91637908|NCT02452892|183167699|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.294||||||For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.294
91637909|NCT02452892|183167699|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.232||||||For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.232
91637910|NCT02452892|183167700|SUPERIORITY|||||||0.0932||||||P-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.0932
91792876|NCT02751931|183463239|OTHER||Mean Difference (Net)|1.3||||0.613|TWO_SIDED|95.0|-3.96|6.57||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||6.57|-3.96|0.613
91792877|NCT02751931|183463239|OTHER||Mean Difference (Net)|-6.79||||0.056|TWO_SIDED|95.0|-13.78|0.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.20|-13.78|0.056
91792878|NCT02751931|183463240|OTHER||Mean Difference (Net)|0.36||||0.153|TWO_SIDED|95.0|-0.14|0.86||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||0.86|-0.14|0.153
91637911|NCT02452892|183167700|SUPERIORITY|||||||0.7509||||||The p-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.7509
91715683|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.11|||ANCOVA|||Day 14/early termination analysis||-0.11|-0.53|
91637912|NCT02452892|183167701|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.2672||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.2672
91485487|NCT02413372|182844051|SUPERIORITY||Mean Difference (Final Values)|-7.17|||||TWO_SIDED|90.0|-9.09|-5.26|||||mean difference in adjusted change from baseline vs placebo|Day 57||-5.26|-9.09|
91637913|NCT02452892|183167701|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.166||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.1660
91637914|NCT02452892|183167702|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~* All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~* The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~* The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
91637915|NCT02452892|183167702|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3537||||||"P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.~."|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3537
91637916|NCT02452892|183167703|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0848||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0848
91637917|NCT02452892|183167703|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.593||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.5930
91637918|NCT02452892|183167704|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
91637919|NCT02452892|183167704|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3907||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3907
91637920|NCT02347124|183167705|SUPERIORITY||Odds Ratio (OR)|1.29||||0.13|TWO_SIDED|95.0|0.93|1.78||Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.|Regression, Logistic|||||1.78|0.93|0.13
91637921|NCT02347124|183167706|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9|TWO_SIDED|95.0|0.69|1.53||Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.|Regression, Logistic|||||1.53|0.69|0.90
91637922|NCT02347124|183167707|SUPERIORITY||Odds Ratio (OR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.69||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.69|0.89|0.21
91637923|NCT02347124|183167708|SUPERIORITY||Odds Ratio (OR)|1.42||||0.04|TWO_SIDED|95.0|1.01|2.0||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||2.00|1.01|0.04
91672220|NCT00562120|183239663|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.252
91672221|NCT00562120|183239663|SUPERIORITY_OR_OTHER|||||||0.479|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.479
91637924|NCT02347124|183167709|SUPERIORITY||Odds Ratio (OR)|1.37||||0.09|TWO_SIDED|95.0|0.95|1.96||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.96|0.95|0.09
91637925|NCT02347124|183167710|SUPERIORITY||Odds Ratio (OR)|-0.05||||0.85|TWO_SIDED|95.0|-0.57|0.47|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.47|-0.57|0.85
91637926|NCT02347124|183167711|SUPERIORITY||Odds Ratio (OR)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.96|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.96|-0.14|0.14
91637927|NCT02347124|183167712|SUPERIORITY||Odds Ratio (OR)|0.35||||0.002|TWO_SIDED|95.0|0.13|0.56|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline self-efficacy score.||||0.56|0.13|.002
91637928|NCT02347124|183167713|SUPERIORITY||Odds Ratio (OR)|0.0||||0.97|TWO_SIDED|95.0|-0.22|0.23||Adjusted for sex, age, state quit line, and baseline self-efficacy score.|Regression, Linear|||||0.23|-0.22|0.97
91637929|NCT02347124|183167714|SUPERIORITY||Odds Ratio (OR)|-0.1||||0.16|TWO_SIDED|95.0|-0.24|0.04|||Regression, Linear|Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.||||0.04|-0.24|0.16
91637930|NCT02347124|183167715|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.83|TWO_SIDED|95.0|-0.16|0.13|||Regression, Linear|Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.||||0.13|-0.16|0.83
91637931|NCT02347124|183167716|SUPERIORITY||Odds Ratio (OR)|0.22||||0.02|TWO_SIDED|95.0|0.04|0.41|||Regression, Linear|adjusted for sex, age, state quit line, and baseline motivation score.||||0.41|0.04|0.02
91637932|NCT02347124|183167717|SUPERIORITY||Odds Ratio (OR)|0.02||||0.82|TWO_SIDED|95.0|-0.17|0.21|||Regression, Linear|||||0.21|-0.17|0.82
91637933|NCT02347124|183167718|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.16|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.||||0.16|-0.20|0.80
91637934|NCT02347124|183167719|SUPERIORITY||Odds Ratio (OR)|0.07||||0.45|TWO_SIDED|95.0|-0.11|0.26|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.||||0.26|-0.11|0.45
91637935|NCT03742271|183167725|SUPERIORITY|Superiority was concluded in the lower limit of the 95% confidence interval was above 0.50.|Proportion|0.974|||||TWO_SIDED|95.0|0.925|0.995|||Binomial Exact Test|||This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.||0.995|0.925|
91637936|NCT03137173|183167727|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% confidence interval (CI) of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the Cochran-Mantel-Haenszel (CMH) weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-1.2|7.8||||||||7.8|-1.2|
91637937|NCT03137173|183167728|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-3.5|5.6||||||||5.6|-3.5|
91637938|NCT03137173|183167729|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin plus aztreonam) using a 10% non-inferiority margin in the CE populations. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-0.3|5.6||||||||5.6|-0.3|
91637939|NCT01535638|183167730|SUPERIORITY_OR_OTHER||Ratio (%)|123.4|STANDARD_DEVIATION|17.1|||TWO_SIDED|90.0|108.0|141.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|Relative bioavailability comparison of Deleobuvir Trial Formulation II (reference) and Deleobuvir Final Formulation (test) in pairwise comparison. (reference : test)||141.1|108.0|
91637940|NCT01535638|183167730|SUPERIORITY_OR_OTHER||Ratio (%)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|88.6|136.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (reference : test)||136.1|88.6|
91672222|NCT00562120|183239663|SUPERIORITY_OR_OTHER|||||||0.521|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.521
91672223|NCT00562120|183239663|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
91672224|NCT00562120|183239664|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.130
91715684|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.05|0.37|||ANCOVA|||Day /early termination analysis||0.37|-0.05|
91637941|NCT01535638|183167731|SUPERIORITY_OR_OTHER||Ratio (%)|122.5|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|107.9|139.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation (test) and Deleobuvir Trial Formulation II (reference) in pairwise comparison. (test : reference)||139.1|107.9|
91792879|NCT02751931|183463240|OTHER||Mean Difference (Net)|0.64||||0.007|TWO_SIDED|95.0|0.19|1.08||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.08|0.19|0.007
91637942|NCT01535638|183167731|SUPERIORITY_OR_OTHER||Ratio (%)|107.6|STANDARD_DEVIATION|35.0|||TWO_SIDED|90.0|83.1|139.4|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (test : reference)||139.4|83.1|
91637943|NCT03524664|183167741|SUPERIORITY|||||||0.523||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71) = 0.411, p =.523||Repeated measures ANOVA||||.523
91637944|NCT03524664|183167742|SUPERIORITY|||||||0.173||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.89, p=.173||Repeated measures ANOVA||||.173
91637945|NCT03524664|183167743|SUPERIORITY|||||||0.14||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.23, p=.140||Outcome data analyzed for those with complete data at both timepoints.||||.140
91637946|NCT03524664|183167744|SUPERIORITY|||||||0.845||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.039, p=0.845||Outcome data analyzed for those with complete data at both timepoints.||||0.845
91637947|NCT03524664|183167745|SUPERIORITY|||||||0.147||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=2.147, p=.147||Outcome data analyzed for those with complete data at both timepoints.||||.147
91637948|NCT03524664|183167746|SUPERIORITY|||||||0.429||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.633, p=.429||Outcome data analyzed for those with complete data at both timepoints.||||.429
91637949|NCT03524664|183167747|SUPERIORITY|||||||0.208||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=1.618, p=.208||Outcome data analyzed for those with complete data at both timepoints.||||.208
91637950|NCT03524664|183167748|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.09, p=.300||Outcome data analyzed for those with complete data at both timepoints.||||.300
91637951|NCT03524664|183167749|SUPERIORITY|||||||0.099||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.79, p=.099||Outcome data analyzed for those with complete data at both timepoints.||||.099
91637952|NCT03524664|183167750|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.70, p=.105||Outcome data analyzed for those with complete data at both timepoints.||||.105
91637953|NCT03524664|183167751|SUPERIORITY|||||||0.699||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.15, p=.699||Repeated measures ANOVA||||.699
91637954|NCT03524664|183167752|SUPERIORITY|||||||0.945||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.005, p=.945||Repeated measures ANOVA||||.945
91637955|NCT03524664|183167753|SUPERIORITY|||||||0.767||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.088, p=.767||Repeated measures ANOVA||||.767
91637956|NCT03524664|183167754|SUPERIORITY|||||||0.682||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=.0.17, p=.682||Repeated measures ANOVA||||.682
91637957|NCT03524664|183167755|SUPERIORITY|||||||0.96||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.003, p=.960||Repeated measures ANOVA||||.960
91637958|NCT03524664|183167756|SUPERIORITY|||||||0.643||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.218, p=.643||Repeated measures ANOVA||||.643
91637959|NCT03524664|183167757|SUPERIORITY|||||||0.118||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time X Group F(2,90)=2.19, p.118||Repeated measures ANOVA||||.118
91637960|NCT03524664|183167758|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time x Group F(2,90)=.223, p=.800||Repeated measures ANOVA||||.800
91637961|NCT03524664|183167759|SUPERIORITY|||||||0.863||||||The threshold for statistical significance was p = 0.05.|ANOVA|Group x Time F(2,92)=0.148, p=.863||Repeated measures ANOVA||||.863
91637962|NCT01522391|183167796|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
91637963|NCT01522391|183167797|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
91637964|NCT01522391|183167798|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.66|0.022|0.242
91637965|NCT01522391|183167798|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
91637966|NCT01522391|183167799|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.660|0.022|0.242
91637967|NCT01522391|183167799|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
91637968|NCT01522391|183167800|OTHER||Ratio between geometric means|0.288||||0.395|TWO_SIDED|95.0|0.016|5.221|||Mixed Models Analysis|||Day 7||5.221|0.016|0.395
91637969|NCT01522391|183167800|OTHER||Ratio between geometric means|0.067||||0.067|TWO_SIDED|95.0|0.004|1.218|||Mixed Models Analysis|||Day 14||1.218|0.004|0.067
91637970|NCT01522391|183167800|OTHER||Ratio between geometric means|0.484||||0.62|TWO_SIDED|95.0|0.027|8.787|||Mixed Models Analysis|||Day 21||8.787|0.027|0.620
91637971|NCT01522391|183167801|OTHER||Ratio between geometric means|0.287||||0.403|TWO_SIDED|95.0|0.015|5.55|||Mixed Models Analysis|||Day 7||5.550|0.015|0.403
91637972|NCT01522391|183167801|OTHER||Ratio between geometric means|0.032||||0.021|TWO_SIDED|95.0|0.002|0.583|||Mixed Models Analysis|||Day 14||0.583|0.002|0.021
91637973|NCT01522391|183167801|OTHER||Ratio between geometric means|0.271||||0.368|TWO_SIDED|95.0|0.015|4.779|||Mixed Models Analysis|||Day 21||4.779|0.015|0.368
91485488|NCT02413372|182844051|SUPERIORITY||Mean Difference (Final Values)|-5.19|||||TWO_SIDED|90.0|-7.14|-3.25|||||mean difference in adjusted change from baseline vs placebo|Day 57||-3.25|-7.14|
91637974|NCT01522391|183167802|OTHER||Ratio between geometric means|1.045||||0.97|TWO_SIDED|95.0|0.106|10.32|||Mixed Models Analysis|||Day 7||10.32|0.106|0.970
91672225|NCT00562120|183239664|SUPERIORITY_OR_OTHER|||||||0.663|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.663
91672226|NCT00562120|183239664|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.138
91792880|NCT02751931|183463240|OTHER||Mean Difference (Net)|0.42||||0.106|TWO_SIDED|95.0|-0.1|0.93||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.93|-0.10|0.106
91485489|NCT02413372|182844051|SUPERIORITY||Mean Difference (Final Values)|-5.43||||0.0004|TWO_SIDED|90.0|-8.01|-2.84|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-2.84|-8.01|0.0004
91637975|NCT01522391|183167802|OTHER||Ratio between geometric means|0.045||||0.009|TWO_SIDED|95.0|0.005|0.447|||Mixed Models Analysis|||Day 14||0.447|0.005|0.009
91637976|NCT01522391|183167802|OTHER||Ratio between geometric means|0.36||||0.377|TWO_SIDED|95.0|0.036|3.556|||Mixed Models Analysis|||Day 21||3.556|0.036|0.377
91637977|NCT01522391|183167803|OTHER||Ratio between geometric means|0.961||||0.974|TWO_SIDED|95.0|0.081|11.43|||Mixed Models Analysis|||Day 7||11.43|0.081|0.974
91637978|NCT01522391|183167803|OTHER||Ratio between geometric means|0.046||||0.013|TWO_SIDED|95.0|0.004|0.512|||Mixed Models Analysis|||Day 14||0.512|0.004|0.013
91637979|NCT01522391|183167803|OTHER||Ratio between geometric means|0.447||||0.504|TWO_SIDED|95.0|0.041|4.883|||Mixed Models Analysis|||Day 21||4.883|0.041|0.504
91637980|NCT01522391|183167804|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.659|||Mixed Models Analysis|||Day 7||2.659|0.022|0.242
91637981|NCT01522391|183167804|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||Day 14||0.491|0.004|0.012
91637982|NCT01522391|183167804|OTHER||Ratio between geometric means|0.428||||0.483|TWO_SIDED|95.0|0.039|4.697|||Mixed Models Analysis|||Day 21||4.697|0.039|0.483
91637983|NCT01522391|183167805|OTHER||Ratio between geometric means|0.202||||0.197|TWO_SIDED|95.0|0.017|2.34|||Mixed Models Analysis|||Day 7||2.340|0.017|0.197
91637984|NCT01522391|183167805|OTHER||Ratio between geometric means|0.021||||0.002|TWO_SIDED|95.0|0.002|0.227|||Mixed Models Analysis|||Day 14||0.227|0.002|0.002
91637985|NCT01522391|183167805|OTHER||Ratio between geometric means|0.257||||0.257|TWO_SIDED|95.0|0.024|2.752|||Mixed Models Analysis|||Day 21||2.752|0.024|0.257
91637986|NCT01522391|183167806|OTHER||Least Square Mean Difference|20.38||||0.346|TWO_SIDED|95.0|-22.42|63.19|||Mixed Models Analysis|||Day 7||63.19|-22.42|0.346
91637987|NCT01522391|183167806|OTHER||Least Square Mean Difference|29.1||||0.18|TWO_SIDED|95.0|-13.71|71.9|||Mixed Models Analysis|||Day 14||71.90|-13.71|0.18
91637988|NCT01522391|183167806|OTHER||Least Square Mean Difference|-11.64||||0.59|TWO_SIDED|95.0|-54.44|31.16|||Mixed Models Analysis|||Day 21||31.16|-54.44|0.590
91637989|NCT01522391|183167807|OTHER||Least Square Mean Difference|5.95||||0.748|TWO_SIDED|95.0|-30.84|42.73|||Mixed Models Analysis|||Day 7||42.73|-30.84|0.748
91637990|NCT01522391|183167807|OTHER||Least Square Mean Difference|14.62||||0.437|TWO_SIDED|95.0|-22.65|51.88|||Mixed Models Analysis|||Day 14||51.88|-22.65|0.437
91637991|NCT01522391|183167807|OTHER||Least Square Mean Difference|-18.66||||0.322|TWO_SIDED|95.0|-55.92|18.61|||Mixed Models Analysis|||Day 21||18.61|-55.92|0.322
91637992|NCT01522391|183167808|OTHER||Least Square Mean Difference|8.04||||0.631|TWO_SIDED|95.0|-25.15|41.24|||Mixed Models Analysis|||Day 7||41.24|-25.15|0.631
91637993|NCT01522391|183167808|OTHER||Least Square Mean Difference|20.44||||0.224|TWO_SIDED|95.0|-12.75|53.63|||Mixed Models Analysis|||Day 14||53.63|-12.75|0.224
91637994|NCT01522391|183167808|OTHER||Least Square Mean Difference|-1.23||||0.941|TWO_SIDED|95.0|-34.42|31.96|||Mixed Models Analysis|||Day 21||31.96|-34.42|0.941
91637995|NCT01522391|183167809|OTHER||Least Square Means Difference|0.97||||0.954|TWO_SIDED|95.0|-32.93|34.87|||Mixed Models Analysis|||Day 7||34.87|-32.93|0.954
91637996|NCT01522391|183167809|OTHER||Least Square Mean Difference|15.72||||0.358|TWO_SIDED|95.0|-18.18|49.62|||Mixed Models Analysis|||Day 14||49.62|-18.18|0.358
91637997|NCT01522391|183167809|OTHER||least Square Mean Difference|-7.94||||0.642|TWO_SIDED|95.0|-41.82|25.94|||Mixed Models Analysis|||Day 21||25.94|-41.82|0.642
91637998|NCT01522391|183167810|OTHER|||||||0.701|||||||Cochran-Mantel-Haenszel|||Day 7||||0.701
91637999|NCT01522391|183167810|OTHER|||||||0.898|||||||Cochran-Mantel-Haenszel|||Day 14||||0.898
91638000|NCT01522391|183167810|OTHER|||||||0.271|||||||Cochran-Mantel-Haenszel|||Day 21||||0.271
91638001|NCT01522391|183167811|OTHER|||||||0.511|||||||Cochran-Mantel-Haenszel|||Day 7||||0.511
91638002|NCT01522391|183167811|OTHER|||||||0.777|||||||Cochran-Mantel-Haenszel|||Day 14||||0.777
91638003|NCT01522391|183167811|OTHER|||||||0.204|||||||Cochran-Mantel-Haenszel|||Day 21||||0.204
91638004|NCT01522391|183167812|OTHER|||||||0.489|||||||Cochran-Mantel-Haenszel|||Day 7||||0.489
91638005|NCT01522391|183167812|OTHER|||||||0.249|||||||Cochran-Mantel-Haenszel|||Day 14||||0.249
91638006|NCT01522391|183167812|OTHER|||||||0.098|||||||Cochran-Mantel-Haenszel|||Day 21||||0.098
91638007|NCT01522391|183167813|OTHER|||||||0.291|||||||Cochran-Mantel-Haenszel|||Day 7||||0.291
91638008|NCT01522391|183167813|OTHER|||||||0.113|||||||Cochran-Mantel-Haenszel|||Day 14||||0.113
91672227|NCT00562120|183239664|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.124
91715685|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.17|0.25|||ANCOVA|||Day 14/early termination analysis||0.25|-0.17|
91485490|NCT02413372|182844051|SUPERIORITY||Mean Difference (Final Values)|-3.85||||0.0084|TWO_SIDED|90.0|-6.47|-1.23|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-1.23|-6.47|0.0084
91485491|NCT01480089|182844069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.308|STANDARD_ERROR_OF_MEAN|0.777||0.098|TWO_SIDED|95.0|-2.83|0.214|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.214|-2.830|.098
91485492|NCT01480089|182844070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.53||0.9|TWO_SIDED|95.0|-1.103|0.973|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.973|-1.103|.90
91485493|NCT03053271|182844082|OTHER|No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||||||||||||||||No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||
91638009|NCT01522391|183167813|OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|||Day 21||||0.033
91638010|NCT01522391|183167814|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
91638011|NCT01522391|183167814|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 14||||0.825
91638012|NCT01522391|183167814|OTHER|||||||0.208|||||||Cochran-Mantel-Haenszel|||||||0.208
91638013|NCT01522391|183167815|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
91638014|NCT01522391|183167815|OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Day 14||||0.820
91638015|NCT01522391|183167815|OTHER|||||||0.086|||||||Cochran-Mantel-Haenszel|||Day 21||||0.086
91638016|NCT01522391|183167816|OTHER|||||||0.378|||||||Cochran-Mantel-Haenszel|||Day 7||||0.378
91638017|NCT01522391|183167816|OTHER|||||||0.975|||||||Cochran-Mantel-Haenszel|||Day 14||||0.975
91638018|NCT01522391|183167816|OTHER|||||||0.962|||||||Cochran-Mantel-Haenszel|||Day 21||||0.962
91638019|NCT01522391|183167817|OTHER|||||||0.375|||||||Cochran-Mantel-Haenszel|||Day 7||||0.375
91638020|NCT01522391|183167817|OTHER|||||||0.946|||||||Cochran-Mantel-Haenszel|||Day 14||||0.946
91638021|NCT01522391|183167817|OTHER|||||||0.495|||||||Cochran-Mantel-Haenszel|||Day 21||||0.495
91638022|NCT01522391|183167820|OTHER|||||||0.477|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.477
91638023|NCT01522391|183167820|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Day 14 morning||||0.651
91638024|NCT01522391|183167820|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 21 morning||||0.340
91638025|NCT01522391|183167821|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.300
91638026|NCT01522391|183167821|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.705
91638027|NCT01522391|183167821|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Day 21||||0.286
91638028|NCT02514889|183167842|SUPERIORITY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.05||0.3|TWO_SIDED|95.0|-6.12|1.91||a priori threshold is p = .017, so that experiment-wide critical alpha would be p = .05.|Mixed Models Analysis|Covariates: sex, age, ethnicity, marital status and educational attainment|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||1.91|-6.12|0.30
91638029|NCT02514889|183167843|EQUIVALENCE|p-value \>0.20 would be considered equivalent.|Mean Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|1.39||0.06|TWO_SIDED|95.0|-0.1342|5.3228|||Mixed Models Analysis|Covariates included age, sex, ethnicity, educational attainment and marital status||||5.3228|-0.1342|0.06
91638030|NCT02514889|183167844|SUPERIORITY||Mean Difference (Net)|-1.37|STANDARD_ERROR_OF_MEAN|2.55||0.504|TWO_SIDED|95.0|-6.37|3.63|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||3.63|-6.37|0.504
91638031|NCT02514889|183167845|SUPERIORITY|Difference in differences|Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|2.35||0.3|TWO_SIDED|95.0|-6.47|2.74|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment, marital status|The difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.74|-6.47|0.30
91638032|NCT02514889|183167846|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.99||0.64|TWO_SIDED|95.0|-1.47|2.39|||Mixed Models Analysis||The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.39|-1.47|0.640
91638033|NCT02514889|183167847|EQUIVALENCE|For the comparison conditions to be equivalent, as predicted, the critical alpha was set at P \> 0.20.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.135||0.747|TWO_SIDED|95.0|-0.31|0.22|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||0.22|-.31|0.747
91638034|NCT02514889|183167848|EQUIVALENCE|For the comparison conditions to be judged equivalent, as predicted, the critical p-value was set to P \>.20|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.51||0.776|TWO_SIDED|95.0|-0.85|1.14|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||1.14|-0.85|0.776
91638035|NCT01519648|183167938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.872|STANDARD_ERROR_OF_MEAN|0.237||0.007|TWO_SIDED|95.0|1.178|2.977|||Chi-squared|||||2.977|1.178|0.007
91638036|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|-1.99|2.9||||||||2.90|-1.99|
91638037|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.73|2.24||||||||2.24|-2.73|
91638038|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.25|2.79||||||||2.79|-2.25|
91638039|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-1.94|3.09||||||||3.09|-1.94|
91485494|NCT00580970|182844087|SUPERIORITY_OR_OTHER|||||||0.9138||||||Considering all late rectal toxicities, 38% (20/53) of participants developed physician reported Grade 2 or higher GI toxicity during 2 year follow up. The threshold for significance was p \< 0.05.|t-test, 1 sided|A one sided t-test, with 5% level of significance, and 83% power was used which required 53 subjects.||||||0.9138
91485495|NCT03161093|182844092|SUPERIORITY||Least Squares Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.028|-0.324|||Mixed Models Analysis|||||-0.324|-1.028|0.0002
91485496|NCT03161093|182844093|SUPERIORITY||Least Squares Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.178|<|0.0001|TWO_SIDED|95.0|-1.046|-0.346|||Mixed Models Analysis|||||-0.346|-1.046|<0.0001
91485497|NCT03161093|182844094|SUPERIORITY||Least Squares Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.254||0.7036|TWO_SIDED|95.0|-0.594|0.401|||Mixed Models Analysis|||||0.401|-0.594|0.7036
91485498|NCT03161093|182844095|SUPERIORITY||Least Squares Mean|-0.18|STANDARD_ERROR_OF_MEAN|0.243||0.4605|TWO_SIDED|95.0|-0.657|0.297|||Mixed Models Analysis|||||0.297|-0.657|0.4605
91485499|NCT00570765|182844141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||Hierarchical testing strategy was proposed to account for multiple comparisons. Statistical significance was evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10 mg OCA versus placebo, then the statistical significance at alpha=0.05 for the 50 mg OCA versus placebo was evaluated. If no statistical significance was shown at alpha=0.05 at the first step, then the subsequent comparison was not considered statistically significant.||||<0.0001
91485500|NCT00570765|182844142|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||||||<0.0001
91485501|NCT00570765|182844143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.||||||<0.01
91638040|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.62|2.35||||||||2.35|-2.62|
91638041|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-0.88|4.11||||||||4.11|-0.88|
91638042|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|-1.63|3.85||||||||3.85|-1.63|
91638043|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|90.0|-3.13|2.79||||||||2.79|-3.13|
91638044|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|90.0|-2.6|4.47||||||||4.47|-2.60|
91638045|NCT03808298|183167943|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.03|2.98||||||||2.98|-2.03|
91638046|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-0.19|2.64||||||||2.64|-0.19|
91638047|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-0.12|2.33||||||||2.33|-0.12|
91638048|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.4|3.67||||||||3.67|0.40|
91638049|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|0.6|4.49||||||||4.49|0.60|
91638050|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|0.09|4.94||||||||4.94|0.09|
91638051|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|90.0|-1.62|4.47||||||||4.47|-1.62|
91638052|NCT03808298|183167944|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-0.1|3.39||||||||3.39|-0.10|
91638053|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.6|2.2||||||||2.20|-0.60|
91638054|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.13|2.55||||||||2.55|0.13|
91638055|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|1.7|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|0.04|3.27||||||||3.27|0.04|
91638056|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.64|3.2||||||||3.20|-0.64|
91638057|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.3|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-0.13|4.67||||||||4.67|-0.13|
91638058|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.82|||TWO_SIDED|90.0|-2.31|3.7||||||||3.70|-2.31|
91638059|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.35|2.1||||||||2.10|-1.35|
91638060|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|-2.94|1.89||||||||1.89|-2.94|
91638061|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|-3.19|1.72||||||||1.72|-3.19|
91638062|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.26|2.74||||||||2.74|-2.26|
91638063|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.02|2.96||||||||2.96|-2.02|
91638064|NCT03808298|183167945|EQUIVALENCE|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-2.39|2.54||||||||2.54|-2.39|
91638065|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.67|4.28||||||||4.28|-0.67|
91638066|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.11|3.31||||||||3.31|-2.11|
91638067|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-2.38|3.47||||||||3.47|-2.38|
91638068|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-2.85|4.14||||||||4.14|-2.85|
91638069|NCT03808298|183167945|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.36|2.6||||||||2.60|-2.36|
91672228|NCT00562120|183239664|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
91792881|NCT02751931|183463240|OTHER||Mean Difference (Net)|0.95||||0.003|TWO_SIDED|95.0|0.38|1.51||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||1.51|0.38|0.003
91638070|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-1.2|0.73||||||||0.73|-1.20|
91638071|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.08|0.96||||||||0.96|-1.08|
91638072|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.73|0.78||||||||0.78|-1.73|
91638073|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-1.8|0.7||||||||0.70|-1.80|
91638074|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-2.42|1.05||||||||1.05|-2.42|
91638075|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-2.66|1.24||||||||1.24|-2.66|
91672229|NCT00562120|183239664|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.978
91672230|NCT00562120|183239665|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.357
91792882|NCT04090411|183463255|SUPERIORITY||Risk Difference (RD)|13.9||||0.0545|TWO_SIDED|90.0|-0.2|27.65||One-sided P-value|Chan and Zhang Method|||||27.65|-0.20|0.0545
91638076|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-1.91|0.85||||||||0.85|-1.91|
91672231|NCT00562120|183239665|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
91638077|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.9|-0.48||||||||-0.48|-3.90|
91638078|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.41|0.0||||||||0.00|-3.41|
91638079|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-3.21|0.36||||||||0.36|-3.21|
91638080|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-3.25|0.01||||||||0.01|-3.25|
91638081|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.36|-0.01||||||||-0.01|-3.36|
91638082|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-3.75|-0.14||||||||-0.14|-3.75|
91638083|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.06|0.29||||||||0.29|-3.06|
91638084|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-3.08|1.01||||||||1.01|-3.08|
91638085|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.03|0.76||||||||0.76|-3.03|
91638086|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.13|||TWO_SIDED|90.0|-2.87|0.87||||||||0.87|-2.87|
91638087|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.89|1.07||||||||1.07|-0.89|
91638088|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.21|0.86||||||||0.86|-1.21|
91638089|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|90.0|-1.71|0.83||||||||0.83|-1.71|
91792883|NCT04090411|183463255|SUPERIORITY||Risk Difference (RD)|11.71||||0.0823|TWO_SIDED|90.0|-1.7|24.09||One-sided P-value|Chan and Zhang Method|||||24.09|-1.70|0.0823
91672232|NCT00562120|183239665|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.480
91672233|NCT00562120|183239665|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.043
91672234|NCT00562120|183239665|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.087
91672235|NCT00562120|183239665|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.753
91672236|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.011
91672237|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.127
91672238|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.103
91672239|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.218
91672240|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.905
91792884|NCT04090411|183463255|SUPERIORITY||Risk Difference (RD)|12.24||||0.0642|TWO_SIDED|90.0|-0.64|22.91||One-sided P-value|Chan and Zhang Method|||||22.91|-0.64|0.0642
91672241|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.273
91792885|NCT04090411|183463262|SUPERIORITY||Risk Difference (RD)|7.92||||0.1398|TWO_SIDED|90.0|-3.62|20.04||One-sided P-value|Chan and Zhang Method|||||20.04|-3.62|0.1398
91672242|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
91672243|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.055|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.055
91672244|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.012
91672245|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.048
91792886|NCT04090411|183463262|SUPERIORITY||Risk Difference (RD)|6.36||||0.2038|TWO_SIDED|90.0|-4.88|17.06||One-sided P-value|Chan and Zhang Method|||||17.06|-4.88|0.2038
91792887|NCT04090411|183463262|SUPERIORITY||Risk Difference (RD)|7.8||||0.1498|TWO_SIDED|90.0|-3.7|17.06||One-sided P-value|Chan and Zhang Method|||||17.06|-3.70|0.1498
91672246|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.496|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.496
91672247|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.190
91672248|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
91792888|NCT04090411|183463263|SUPERIORITY||Risk Difference (RD)|18.16||||0.0189|TWO_SIDED|90.0|3.25|32.23||One-sided P-value|Chan and Zhang Method|||||32.23|3.25|0.0189
91792889|NCT04090411|183463263|SUPERIORITY||Risk Difference (RD)|23.37||||0.0045|TWO_SIDED|90.0|6.24|36.28||One-sided P-value|Chan and Zhang Method|||||36.28|6.24|0.0045
91672249|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.019
91672250|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.009
91672251|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.061
91672252|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.778|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.778
91672253|NCT00562120|183239666|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.102
91672254|NCT00562120|183239667|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
91672255|NCT00562120|183239667|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
91672256|NCT00562120|183239667|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
91672257|NCT00562120|183239667|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.217
91672258|NCT00562120|183239667|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.156
91672259|NCT00562120|183239667|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.848
91672260|NCT02148445|183239669|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%.||||||0.88|||||||Chi-squared|||||||0.88
91672261|NCT02148445|183239670|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. This sample size will provide comparable power for looking at 6 month sustained cessation.||||||0.55|||||||Chi-squared|||||||0.55
91672262|NCT02148445|183239671|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
91672263|NCT02148445|183239672|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91672264|NCT02148445|183239673|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91792890|NCT04090411|183463263|SUPERIORITY||Risk Difference (RD)|20.19||||0.0117|TWO_SIDED|90.0|3.22|31.31||One-sided P-value|Chan and Zhang Method|||||31.31|3.22|0.0117
91672265|NCT02148445|183239674|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||||||0.39
91672266|NCT02148445|183239675|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
91672267|NCT02148445|183239676|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
91672268|NCT02148445|183239677|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
91672269|NCT02148445|183239679|SUPERIORITY|||||||0.08|||||||Chi-squared|||Month 3 self-reported abstinence||||0.08
91672270|NCT02148445|183239679|SUPERIORITY|||||||0.06|||||||Chi-squared|||Month 3 biochemically verified abstinence||||0.06
91672271|NCT02148445|183239679|SUPERIORITY|||||||0.22|||||||Chi-squared|||Month 6, self-reported abstinence||||0.22
91672272|NCT02148445|183239679|SUPERIORITY|||||||0.34|||||||Chi-squared|||Month 6, biochemically verified abstinence||||0.34
91672273|NCT02148445|183239679|SUPERIORITY|||||||0.66|||||||Chi-squared|||Month 12, self-reported abstinence||||0.66
91672274|NCT02148445|183239680|SUPERIORITY|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
91672275|NCT02148445|183239681|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91672276|NCT02148445|183239682|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91672277|NCT02148445|183239683|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
91672278|NCT02148445|183239684|SUPERIORITY|||||||0.0918|||||||Mixed Models Analysis|||||||0.0918
91672279|NCT03450629|183239685|EQUIVALENCE|8 AM +/- 30 min||||||0.0006|||||||t-test, 2 sided|||||||0.0006
91672280|NCT03450629|183239685|EQUIVALENCE|10 AM +/- 30 min||||||0.0291|||||||t-test, 2 sided|||||||0.0291
91792891|NCT04090411|183463264|SUPERIORITY||Risk Difference (RD)|21.82||||0.0146|TWO_SIDED|90.0|4.14|37.3||One-sided P-value|Chan and Zhang Method|||||37.30|4.14|0.0146
91638090|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.07|1.46||||||||1.46|-1.07|
91638091|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|-2.5|1.0||||||||1.00|-2.50|
91485502|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.12||||||Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.12|0.74|
91638092|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|-2.22|1.74||||||||1.74|-2.22|
91638093|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-3.63|-0.85||||||||-0.85|-3.63|
91638094|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.42|1.03||||||||1.03|-2.42|
91638095|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline Day 14 HR (bpm) at 0.5 Hours Pre-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.96|0.49||||||||0.49|-2.96|
91638096|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-2.58|1.02||||||||1.02|-2.58|
91638097|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-2.34|0.95||||||||0.95|-2.34|
91638098|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.65|0.73||||||||0.73|-2.65|
91638099|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-3.11|0.53||||||||0.53|-3.11|
91638100|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.73|0.66||||||||0.66|-2.73|
91638101|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-2.77|1.37||||||||1.37|-2.77|
91638102|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-2.5|1.33||||||||1.33|-2.50|
91638103|NCT03808298|183167946|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.57|0.2||||||||0.20|-3.57|
91638104|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-2.56|0.17||||||||0.17|-2.56|
91672281|NCT03450629|183239685|EQUIVALENCE|4 PM +/- 30 min||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91638105|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.62|1.55||||||||1.55|-1.62|
91638106|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|-1.22|2.09||||||||2.09|-1.22|
91638107|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.04|1.33||||||||1.33|-2.04|
91638108|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-1.0|3.33||||||||3.33|-1.00|
91638109|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.56|||TWO_SIDED|90.0|-2.3|2.88||||||||2.88|-2.30|
91638110|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-3.0|0.81||||||||0.81|-3.00|
91638111|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.08|3.35||||||||3.35|-2.08|
91638112|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.48|3.12||||||||3.12|-2.48|
91638113|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.55|3.06||||||||3.06|-2.55|
91638114|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-3.17|3.12||||||||3.12|-3.17|
91638115|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|90.0|-2.47|3.37||||||||3.37|-2.47|
91638116|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|90.0|-3.42|2.34||||||||2.34|-3.42|
91638117|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-3.54|2.12||||||||2.12|-3.54|
91638118|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|-3.31|1.88||||||||1.88|-3.31|
91638119|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|90.0|-1.21|4.09||||||||4.09|-1.21|
91715686|NCT00549549|183322352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.38|0.05|||ANCOVA|||Day 14/early termination analysis||0.05|-0.38|
91792892|NCT04090411|183463264|SUPERIORITY||Risk Difference (RD)|19.73||||0.0167|TWO_SIDED|90.0|2.76|34.05||One-sided P-value|Chan and Zhang Method|||||34.05|2.76|0.0167
91792893|NCT04090411|183463264|SUPERIORITY||Risk Difference (RD)|22.3||||0.0094|TWO_SIDED|90.0|3.22|34.95||One-sided P-value|Chan and Zhang Method|||||34.95|3.22|0.0094
91638120|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|90.0|-2.9|2.49||||||||2.49|-2.90|
91715687|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.22|-0.29|
91715688|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||Day 5 analysis.||0.16|-0.35|
91715689|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.17|0.34|||ANCOVA|||Day 5 analysis.||0.34|-0.17|
91638121|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-2.0|0.77||||||||0.77|-2.00|
91638122|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.71|1.5||||||||1.50|-1.71|
91638123|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.02||||90.0|-1.64|1.73||||||||1.73|-1.64|
91638124|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.39|1.02||||||||1.02|-2.39|
91638125|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-1.26|3.13||||||||3.13|-1.26|
91638126|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.59||||90.0|-3.92|1.35||||||||1.35|-3.92|
91638127|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.96|1.89||||||||1.89|-1.96|
91638128|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|-1.34|4.13||||||||4.13|-1.34|
91638129|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.61|4.05||||||||4.05|-1.61|
91638130|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.32|4.35||||||||4.35|-1.32|
91638131|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|90.0|-3.38|2.97||||||||2.97|-3.38|
91638132|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.78||||90.0|-3.48|2.42||||||||2.42|-3.48|
91638133|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-1.81|4.02||||||||4.02|-1.81|
91638134|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-1.67|4.04||||||||4.04|-1.67|
91638135|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-1.95|3.29||||||||3.29|-1.95|
91638136|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|3.3|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|90.0|0.6|5.96||||||||5.96|0.60|
91638137|NCT03808298|183167947|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-0.72|4.72||||||||4.72|-0.72|
91638138|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.29|0.07||||||||0.07|-0.29|
91638139|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.02|0.34||||||||0.34|-0.02|
91638140|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline (ms) at QRS Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.12||||||||0.12|-0.30|
91638141|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||||0.18|-0.26|
91638142|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.57|0.38||||||||0.38|-0.57|
91638143|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.65|0.56||||||||0.56|-0.65|
91638144|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.15||||90.0|-0.11|0.4||||||||0.40|-0.11|
91715690|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|||Day 5 analysis.||0.30|-0.20|
91715691|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.26|0.25|||ANCOVA|||Day 5 analysis.||0.25|-0.26|
91715692|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||Day 9 analysis.||0.11|-0.36|
91715693|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.44|0.04|||ANCOVA|||Day 9 analysis.||0.04|-0.44|
91715694|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.46|||ANCOVA|||Day 9 analysis.||0.46|-0.01|
91715695|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.14|0.33|||ANCOVA|||Day 9 analysis.||0.33|-0.14|
91715696|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 9 analysis.||0.26|-0.22|
91715697|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.38|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.38|
91638145|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.34|0.74||||||||0.74|-0.34|
91638146|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.17|0.91||||||||0.91|-0.17|
91638147|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.04|1.05||||||||1.05|-0.04|
91638148|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.26|0.82||||||||0.82|-0.26|
91638149|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|32.0|||TWO_SIDED|90.0|-0.18|0.9||||||||0.90|-0.18|
91638150|NCT03808298|183167948|OTHER||LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.08|1.0||||||Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose||1.00|-0.08|
91638151|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.19|0.94||||||||0.94|-0.19|
91638152|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.33|1.1||||||||1.10|-0.33|
91638153|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-0.5|1.06||||||||1.06|-0.50|
91638154|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.06|1.11||||||||1.11|-0.06|
91638155|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.25|0.11||||||||0.11|-0.25|
91638156|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.0|0.36||||||||0.36|0.00|
91638157|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.34|0.09||||||||0.09|-0.34|
91638158|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.34||||||||0.34|-0.10|
91638159|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.57||||||||0.57|-0.40|
91638160|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.31|0.93||||||||0.93|-0.31|
91638161|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|0.07|0.58||||||||0.58|0.07|
91638162|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.19|0.9||||||||0.90|-0.19|
91638163|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.11|0.98||||||||0.98|-0.11|
91638164|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.06|1.05||||||||1.05|-0.06|
91638165|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.27|0.82||||||||0.82|-0.27|
91638166|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.14|0.94||||||||0.94|-0.14|
91638167|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.24|0.86||||||||0.86|-0.24|
91638168|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.07|1.2||||||||1.20|0.07|
91638169|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-0.1|1.35||||||||1.35|-0.10|
91638170|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.5|1.07||||||||1.07|-0.50|
91638171|NCT03808298|183167948|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.14|1.04||||||||1.04|-0.14|
91638172|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.64|4.04||||||||4.04|-1.64|
91638173|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 1 Hours Post-dose|LS Mean|5.4|STANDARD_ERROR_OF_MEAN|1.93|||TWO_SIDED|90.0|2.22|8.63||||||||8.63|2.22|
91638174|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 2.5 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|5.81|11.28||||||||11.28|5.81|
91638175|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 4 Hours Post-dose|LS Mean|8.6|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|5.86|11.34||||||||11.34|5.86|
91638176|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 8 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.43|11.61||||||||11.61|5.43|
91638177|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 12 Hours Post-dose|LS Mean|6.9|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|90.0|3.76|10.0||||||||10.00|3.76|
91638178|NCT03808298|183167970|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 24 Hours Post-dose|LS Mean|6.1|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|3.58|8.62||||||||8.62|3.58|
91638179|NCT02713490|183167972|SUPERIORITY||LSMD|-26.884||||0.0381|TWO_SIDED|95.0|-56.608|2.841|||ANOVA|||||2.841|-56.608|0.0381
91715698|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.52|-0.04|||ANCOVA|||Day 14/early termination analysis||-0.04|-0.52|
91715699|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.08|0.39|||ANCOVA|||Day 14/early termination analysis||0.39|-0.08|
91485503|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.98|0.70|
91638180|NCT02713490|183167973|SUPERIORITY||LSM treatment ratio|0.203||||0.0029|TWO_SIDED|95.0|0.065|0.631|||ANOVA|||||0.631|0.065|0.0029
91638181|NCT02713490|183167974|SUPERIORITY||Treatment difference|0.098||||0.0088|TWO_SIDED|95.0|0.0284|0.1685|||Cochran-Mantel-Haenszel|||||0.1685|0.0284|0.0088
91638182|NCT02713490|183167975|SUPERIORITY|||||||0.023|||||||Log Rank|||Analysis applies to the overall distribution of time to first opioid rescue, estimated from Kaplan-Meier analysis.||||0.0230
91638183|NCT02713490|183167976|SUPERIORITY|||||||0.4285|||||||Kruskal-Wallis|||||||0.4285
91638184|NCT00224952|183168004|OTHER|||||||0.004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.004
91638185|NCT00224952|183168004|OTHER|||||||0.032|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.032
91638186|NCT00224952|183168004|OTHER|||||||0.018|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Fractional Recovery (MTHIS)) as a function of age||||0.018
91638187|NCT00224952|183168004|OTHER|||||||0.033|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery MTHIS)) as a function of age||||0.033
91638188|NCT00224952|183168004|OTHER|||||||0.0004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-3-ene VPA isomers)) as a function of age||||0.0004
91638189|NCT00224952|183168004|OTHER|||||||0.0003|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-2-ene VPA) ) as a function of age||||0.0003
91638190|NCT00224952|183168004|OTHER||||||<|0.0001|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Total N-acetylcysteine conjugates) as a function of age||||<0.0001
91638191|NCT00224952|183168004|OTHER|||||||0.522|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-3-ene VPA isomers)) as a function of age||||0.522
91638192|NCT00224952|183168004|OTHER|||||||0.925|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-2-ene VPA) ) as a function of age||||0.925
91638193|NCT00224952|183168004|OTHER|||||||0.469|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery Total NAC conjugates) as a function of age||||0.469
91638194|NCT00134563|183168005|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|31.5||||0.0005||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was sized to detect a 25% relative risk reduction with teriflunomide in the 2-year relapse rate at a significance level of 0.050 with a power ≥95% anticipating a potential 20% 2-year dropout rate."||||0.0005
91672282|NCT02093923|183239695|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
91672283|NCT02093923|183239695|SUPERIORITY||Percent Change in Mean Rate|-87.77||||0.005|TWO_SIDED|95.0|-97.18|-46.9|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-46.90|-97.18|0.0050
91672284|NCT02093923|183239695|SUPERIORITY||Percent Change in Mean Rate|-91.08||||0.0012||95.0|-97.93|-61.57|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-61.57|-97.93|0.0012
91672285|NCT02093923|183239696|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
91672286|NCT02093923|183239696|SUPERIORITY||Percent Change in Mean Rate|-84.08|||<|0.0001|TWO_SIDED|95.0|-93.07|-63.46|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-63.46|-93.07|<.0001
91715700|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 14/early termination analysis||0.26|-0.22|
91715701|NCT00549549|183322353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.12|||ANCOVA|||Day 14/early termination analysis||0.12|-0.36|
91638195|NCT00134563|183168005|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|31.2||||0.0002||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 7 mg compared to placebo|||||0.0002
91638196|NCT00134563|183168006|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|29.8||||0.0279||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was also sized to detect a 37% hazard rate reduction of an assumed disability progression hazard rate of 0.1783 in the placebo group and 0.1116 in the teriflunomide group by the end of 2 years with a power of 80% anticipating a potential 20% 2-year dropout rate."||||0.0279
91638197|NCT00134563|183168006|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|23.7||||0.0835||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.0835
91638198|NCT00134563|183168007|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0003
91638199|NCT00134563|183168007|SUPERIORITY_OR_OTHER|||||||0.0317||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0317
91638200|NCT00134563|183168010|SUPERIORITY_OR_OTHER|||||||0.8271||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.8271
91638201|NCT00134563|183168010|SUPERIORITY_OR_OTHER|||||||0.3861||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.3861
91672287|NCT02093923|183239696|SUPERIORITY||Percent Change in Mean Rate|-87.84|||<|0.0001|TWO_SIDED|95.0|-94.81|-71.5|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-71.50|-94.81|<.0001
91638202|NCT03382639|183168015|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.66||0.426|TWO_SIDED|95.0|-1.4|1.2|||Mixed Models Analysis|||||1.2|-1.4|0.426
91638203|NCT03382639|183168015|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.66||0.725|TWO_SIDED|95.0|-1.5|1.1|||Mixed Models Analysis|||||1.1|-1.5|0.725
91672288|NCT02093923|183239697|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
91638204|NCT03382639|183168015|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.808|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||||1.9|-0.7|0.808
91638205|NCT00148109|183168065|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||Estimate a 4 month progression-free survival rate for each group.||||<0.05
91638206|NCT06104423|183168068|SUPERIORITY||Mean difference pre vs post treatment|-19.2|STANDARD_DEVIATION|8.62|<|0.001|TWO_SIDED|95.0|-26.0|-14.0|||paired t-test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting systolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 5 (Week 12, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-14.0|-26.0|< 0.001
91638207|NCT00538434|183168069|SUPERIORITY_OR_OTHER||Adjusted mean difference|-52.78|STANDARD_ERROR_OF_MEAN|11.4|<|0.0001|TWO_SIDED|95.0|-75.24|-30.32|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-30.32|-75.24|< 0.0001
91638208|NCT00538434|183168069|SUPERIORITY_OR_OTHER||Adjusted mean difference|-73.03|STANDARD_ERROR_OF_MEAN|11.29|<|0.0001|TWO_SIDED|95.0|-95.28|-50.78|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-50.78|-95.28|< 0.0001
91672289|NCT02093923|183239697|SUPERIORITY||Percent Change in Mean Rate|-82.38|||<|0.0001|TWO_SIDED|95.0|-92.5|-58.64|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-58.64|-92.50|<.0001
91672290|NCT02093923|183239697|SUPERIORITY||Percent Change in Mean Rate|-87.02|||<|0.0001|TWO_SIDED|95.0|-94.55|-69.06|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-69.06|-94.55|<.0001
91715702|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6402|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6402
91715703|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9739|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.9739
91638209|NCT00538434|183168069|SUPERIORITY_OR_OTHER||Adjusted mean difference|-64.69|STANDARD_ERROR_OF_MEAN|11.28|<|0.0001|TWO_SIDED|95.0|-86.93|-42.45|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-42.45|-86.93|< 0.0001
91715704|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4581|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4581
91792894|NCT04090411|183463265|SUPERIORITY||Risk Difference (RD)|12.17||||0.0489|TWO_SIDED|90.0|0.05|25.25||One-sided P-value|Chan and Zhang Method|||||25.25|0.05|0.0489
91638210|NCT00538434|183168070|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0313
91638211|NCT00538434|183168070|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.5793
91638212|NCT00538434|183168070|SUPERIORITY_OR_OTHER|||||||0.4905|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4905
91638213|NCT00538434|183168071|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0062
91638214|NCT00538434|183168071|SUPERIORITY_OR_OTHER|||||||0.0943|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0943
91638215|NCT00538434|183168071|SUPERIORITY_OR_OTHER|||||||0.2955|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2955
91638216|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.75|STANDARD_ERROR_OF_MEAN|6.48||0.4644|TWO_SIDED|95.0|-17.53|8.03||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||8.03|-17.53|0.4644
91638217|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.47|STANDARD_ERROR_OF_MEAN|6.44||0.8196|TWO_SIDED|95.0|-14.17|11.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||11.23|-14.17|0.8196
91638218|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.36|STANDARD_ERROR_OF_MEAN|6.36||0.8306|TWO_SIDED|95.0|-11.19|13.91||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||13.91|-11.19|0.8306
91638219|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.38|STANDARD_ERROR_OF_MEAN|4.37||0.1459|TWO_SIDED|95.0|-15.01|2.24||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||2.24|-15.01|0.1459
91638220|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.41|STANDARD_ERROR_OF_MEAN|4.38||0.4375|TWO_SIDED|95.0|-12.05|5.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||5.23|-12.05|0.4375
91638221|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|4.35||0.9217|TWO_SIDED|95.0|-9.0|8.15||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||8.15|-9.00|0.9217
91638222|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.57|STANDARD_ERROR_OF_MEAN|7.82||0.8412|TWO_SIDED|95.0|-16.98|13.85||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||13.85|-16.98|0.8412
91638223|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.54|STANDARD_ERROR_OF_MEAN|7.81||0.4794|TWO_SIDED|95.0|-20.94|9.87||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||9.87|-20.94|0.4794
91638224|NCT00538434|183168072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|7.66||0.8906|TWO_SIDED|95.0|-16.16|14.06||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||14.06|-16.16|0.8906
91638225|NCT00351611|183168073|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI bound was less than 0.10 (10%).|Difference in percentage of participants|-1.7094|||||TWO_SIDED|95.0|-9.1751|5.9784||||||A 2-sided 95 percent (%) confidence interval (CI) on the difference in percentage of participants, between pregabalin and placebo was constructed using unconditional exact methods.||5.9784|-9.1751|
91638226|NCT00351611|183168074|NON_INFERIORITY|Non-inferiority with respect to mean deviation was demonstrated if the lower bound of the CI is greater than -2.0 decibels.|Difference in LS mean|-0.125||||0.4414|TWO_SIDED|95.0|-0.443|0.194|||ANCOVA|||Analysis of covariance (ANCOVA) with treatment and center in the model and the baseline mean deviation as the covariate was used to construct a 2-sided 95% CI on the difference in least squares (LS) mean between pregabalin and placebo.||0.194|-0.443|0.4414
91638227|NCT00351611|183168075|OTHER||Difference in LS mean|-0.9||||0.1346|TWO_SIDED|95.0|-2.083|0.283|||ANCOVA|||ANCOVA with treatment and center in the model and the baseline visual acuity as the covariate was used to construct a 2-sided 95% confidence interval on the difference in LS mean between pregabalin and placebo.||0.283|-2.083|0.1346
91638228|NCT01589185|183168077|SUPERIORITY|||||||0.3962||||||\< 0.1 is considered borderline significant|Fisher Exact|||The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.||||0.3962
91715705|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2962|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.2962
91715706|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4951
91715707|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4957
91638229|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638230|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638231|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638232|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638233|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638234|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638235|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638236|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91672291|NCT02093923|183239698|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
91672292|NCT02093923|183239698|SUPERIORITY||Percent Change in Mean Rate|-85.24||||0.0141||95.0|-96.79|-32.03|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-32.03|-96.79|0.0141
91638237|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638238|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638239|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638240|NCT03781167|183168155|SUPERIORITY|Week 26 vs Baseline|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638241|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638242|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638243|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638244|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638245|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91672293|NCT02093923|183239698|SUPERIORITY||Percent Change in Mean Rate|-89.35||||0.004|TWO_SIDED|95.0|-97.68|-51.13|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-51.13|-97.68|0.0040
91638246|NCT03781167|183168155|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638247|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 1 vs Baseline||||>0.999
91638248|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.5095|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.5095
91638249|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6962|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.6962
91638250|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
91638251|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0324|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0324
91638252|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638253|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0072|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0072
91638254|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0129|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0129
91638255|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638256|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0119|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0119
91638257|NCT03781167|183168156|SUPERIORITY||||||=|0.22||||||A paired-sample t-test was performed to test the change from Baseline.|paired-sample t-test|||Week 26 vs Baseline||||=0.2200
91638258|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0063|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0063
91638259|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638260|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4331|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4331
91638261|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0045|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0045
91638262|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0049|||||||Wilcoxon (Mann-Whitney)|||Week 52 vs Baseline||||=0.0049
91638263|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6312|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.6312
91638264|NCT03781167|183168156|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1892|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1892
91672294|NCT01181531|183239703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|5.3||0.346|TWO_SIDED|95.0|-15.4|5.4||Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site|Mixed Models Analysis||Cinacalcet - Vitamin D|Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.||5.4|-15.4|0.346
91672295|NCT01181531|183239704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||Stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.29|0.92|0.110
91672296|NCT01181531|183239705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.346|TWO_SIDED|95.0|0.74|2.39||stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.39|0.74|0.346
91792895|NCT04090411|183463265|SUPERIORITY||Risk Difference (RD)|3.02||||0.3396|TWO_SIDED|90.0|-7.66|12.88||One-sided P-value|Chan and Zhang Method|||||12.88|-7.66|0.3396
91638265|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638266|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638267|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638268|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91672297|NCT01631682|183239729|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
91672298|NCT01631682|183239729|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.||||>.05
91792896|NCT04090411|183463265|SUPERIORITY||Risk Difference (RD)|3.25||||0.3995|TWO_SIDED|90.0|-7.42|11.58||One-sided P-value|Chan and Zhang Method|||||11.58|-7.42|0.3995
91638269|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638270|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638271|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638272|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638273|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638274|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638275|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638276|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638277|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638278|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638279|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638280|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638281|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638282|NCT03781167|183168157|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638283|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91672299|NCT01631682|183239729|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||<.05
91715708|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.8364
91715709|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.6892
91638284|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91638285|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91638286|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638287|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638288|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638289|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91672300|NCT01631682|183239729|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
91638290|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638291|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638292|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638293|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638294|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638295|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0042|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0042
91638296|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638297|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638298|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1135|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.1135
91638299|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0029|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0029
91638300|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0026|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0026
91638301|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0034|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0034
91638302|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0103|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0103
91638303|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638304|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0493|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0493
91638305|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3003|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3003
91638306|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0354|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0354
91638307|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2553|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2553
91638308|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.864|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.8640
91638309|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4774|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4774
91638310|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3865|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.3865
91638311|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.1186|||||||paired-sample t-test|||Week 52 vs Baseline||||0.1186
91672301|NCT04034355|183239756|SUPERIORITY||Risk Ratio (RR)|1.521||||0.028|TWO_SIDED|95.0|1.0462|2.2113|||Cochran-Mantel-Haenszel|||||2.2113|1.0462|0.0280
91638312|NCT03781167|183168158|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.083|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0830
91638313|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91638314|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0041|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0041
91638315|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91638316|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91672302|NCT03064438|183239770|SUPERIORITY||Difference of Least Squares (LS) Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.366|TWO_SIDED|95.0|-2.162|5.727|||t-test, 2 sided|||||5.727|-2.162|0.366
91672303|NCT03064438|183239771|SUPERIORITY|||||||0.1099|||||||Van Elteren test|||Percent change from baseline at Week 2||||0.1099
91638317|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638318|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91672304|NCT03064438|183239771|SUPERIORITY|||||||0.1653|||||||Van Elteren test|||Percent change from baseline at Week 4||||0.1653
91672305|NCT03064438|183239771|SUPERIORITY|||||||0.8437|||||||Van Elteren test|||Percent change from baseline at Week 8||||0.8437
91672306|NCT03064438|183239771|SUPERIORITY|||||||0.4644|||||||Van Elteren test|||Percent change from baseline at Week 12||||0.4644
91672307|NCT03064438|183239772|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91672308|NCT03064438|183239773|SUPERIORITY||Difference of LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.91||0.495|TWO_SIDED|95.0|-2.571|5.211|||t-test, 2 sided|||Change from baseline at Week 2||5.211|-2.571|0.495
91672309|NCT03064438|183239773|SUPERIORITY||Difference of LS Mean|-1.5|STANDARD_ERROR_OF_MEAN|1.74||0.399|TWO_SIDED|95.0|-5.014|2.045|||t-test, 2 sided|||Change from baseline at Week 4||2.045|-5.014|0.399
91672310|NCT03064438|183239773|SUPERIORITY||Difference of LS Mean|2.2|STANDARD_ERROR_OF_MEAN|2.07||0.29|TWO_SIDED|95.0|-1.965|6.407|||t-test, 2 sided|||Change from baseline at Week 8||6.407|-1.965|0.290
91672311|NCT03064438|183239773|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.83||0.343|TWO_SIDED|95.0|-1.953|5.469|||t-test, 2 sided|||Change from baseline at Week 12||5.469|-1.953|0.343
91672312|NCT03064438|183239774|SUPERIORITY||Difference of LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.407|TWO_SIDED|95.0|-0.894|2.155|||t-test, 2 sided|||Change from baseline at Week 2||2.155|-0.894|0.407
91672313|NCT03064438|183239774|SUPERIORITY||Difference of LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.36||0.291|TWO_SIDED|95.0|-0.342|1.109|||t-test, 2 sided|||Change from baseline at Week 4||1.109|-0.342|0.291
91672314|NCT03064438|183239774|SUPERIORITY||Difference of LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|95.0|-0.763|1.073|||t-test, 2 sided|||Change from baseline at Week 8||1.073|-0.763|0.734
91638319|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638320|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638321|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638322|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638323|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638324|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638325|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638326|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638327|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638328|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91672315|NCT03064438|183239774|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.952|TWO_SIDED|95.0|-1.128|1.197|||t-test, 2 sided|||Change from baseline in pustule lesions at Week 12||1.197|-1.128|0.952
91672316|NCT03064438|183239775|SUPERIORITY||Difference of LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.313|TWO_SIDED|95.0|-0.215|0.069|||t-test, 2 sided|||Change from baseline at Week 2||0.069|-0.215|0.313
91672317|NCT03064438|183239775|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.942|TWO_SIDED|95.0|-0.141|0.152|||t-test, 2 sided|||Change from baseline at Week 4||0.152|-0.141|0.942
91672318|NCT03064438|183239775|SUPERIORITY||Difference of LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.284|TWO_SIDED|95.0|-0.067|0.226|||t-test, 2 sided|||Change from baseline in nodule lesions at Week 8||0.226|-0.067|0.284
91672319|NCT03064438|183239775|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.542|TWO_SIDED|95.0|-0.198|0.105|||t-test, 2 sided|||Change from baseline at Week 12||0.105|-0.198|0.542
91672320|NCT03064438|183239776|SUPERIORITY||Difference of LS Mean|2.0|STANDARD_ERROR_OF_MEAN|2.04||0.333|TWO_SIDED|95.0|-2.135|6.139|||t-test, 2 sided|||Change from baseline at Week 2||6.139|-2.135|0.333
91672321|NCT03064438|183239776|SUPERIORITY||Difference of LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.9||0.591|TWO_SIDED|95.0|-4.882|2.822|||t-test, 2 sided|||Change from baseline at Week 4||2.822|-4.882|0.591
91672322|NCT03064438|183239776|SUPERIORITY||Difference of LS Mean|2.5|STANDARD_ERROR_OF_MEAN|2.12||0.254|TWO_SIDED|95.0|-1.84|6.758|||t-test, 2 sided|||Change from baseline at Week 8||6.758|-1.840|0.254
91672323|NCT03064438|183239776|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.356|TWO_SIDED|95.0|-2.131|5.779|||t-test, 2 sided|||Change from baseline at Week 12||5.779|-2.131|0.356
91672324|NCT02322788|183239814|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.52|2.29|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.29|1.52|<0.001
91672325|NCT02322788|183239814|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.46|2.2|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.20|1.46|<0.001
91715710|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4110
91715711|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5981|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5981
91715712|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.9317
91792897|NCT02233478|183463285|OTHER||Mean Difference (Final Values)|0.001||||0.82|TWO_SIDED||||||t-test, 2 sided|||"Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.~Due to the quality issue of soybean flour, data from this intervention group was not analyzed."||||0.82
91792898|NCT03764033|183463293|SUPERIORITY||Mean Difference (Net)|0.78|STANDARD_ERROR_OF_MEAN|2.27||0.729|TWO_SIDED|95.0|-3.66|5.24||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||5.24|-3.66|0.729
91792899|NCT03764033|183463294|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|2.31||0.975|TWO_SIDED|95.0|-4.46|4.61||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||4.61|-4.46|0.975
91638329|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638330|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638331|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638332|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638333|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638334|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638335|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638336|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638337|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638338|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638339|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638340|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0091|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0091
91638341|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638342|NCT03781167|183168159|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638343|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4447|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.4447
91638344|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3567|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.3567
91638345|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2315|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.2315
91638346|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0667|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.0667
91638347|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638348|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638349|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638350|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2033|||||||paired-sample t-test|||Week 2 vs Baseline||||=0.2033
91638351|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638352|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0012|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0012
91638353|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0734|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0734
91638354|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638355|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0304|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0304
91638356|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 4 vs Baseline||||>0.999
91638357|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0891|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0891
91638358|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0832|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0832
91638359|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4941|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.4941
91638360|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2764|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.2764
91638361|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3248|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.3248
91672326|NCT02322788|183239814|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.13|0.75|
91672327|NCT02322788|183239814|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.08|0.72|
91672328|NCT02631837|183239825|NON_INFERIORITY|Our hypothesis was that women would accept a higher conversion rate of 15% for vNOTESbased on a telephone interview of 10 women treated by total vaginal NOTES hysterectomy. Women were asked to choose among ﬁve cut-off rates (5, 10, 15, 20 or 25%). Most women indicated 15%. We would conclude non-inferiority when the upper limit of the one-sided 95% conﬁdence interval for the difference in the proportions of women between both comparisons would be below 15%.||||||0.0221||||||The Farrington-Manning test for non-inferiority was performed with 5% significance level and yielded P = 0.0221 in a sensitivity analysis assuming one conversion in the vNOTES and 0 conversions in the laparoscopy group.|Farrington-Manning|||||||0.0221
91672329|NCT02631837|183239826|SUPERIORITY||Risk Difference (RD)|-0.34||||0.007|TWO_SIDED|95.0|-0.56|-0.13|||Fisher Exact|||||-0.13|-0.56|0.007
91672330|NCT02631837|183239826|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
91672331|NCT02631837|183239828|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.006|TWO_SIDED|95.0|-10.0|-1.8|||Mann-Whitney U test|Two-sided test||||-1.8|-10|0.006
91672332|NCT02631837|183239829|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91672333|NCT02631837|183239830|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||> 0.05
91672334|NCT02631837|183239831|SUPERIORITY||Risk Difference (RD)|-0.29||||0.009|TWO_SIDED|95.0|-0.47|-0.1|||Fisher Exact|||||-0.10|-0.47|0.009
91672335|NCT02631837|183239832|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
91672336|NCT02631837|183239833|SUPERIORITY||Median Difference (Final Values)|-34.0|||<|0.01|TWO_SIDED|95.0|-46.0|-22.0|||Mann-Whitney U test|||||-22|-46|< 0.01
91672337|NCT02631837|183239834|SUPERIORITY|||||||0.7604||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.7604
91485504|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.55|0.91||||||Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.91|0.55|
91485505|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.78|
91672338|NCT02631837|183239835|SUPERIORITY|||||||0.3071||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3071
91672339|NCT02631837|183239836|SUPERIORITY|||||||0.4541||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4541
91672340|NCT02631837|183239837|SUPERIORITY|||||||0.4514||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4514
91672341|NCT02631837|183239838|SUPERIORITY|||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
91715713|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0831
91672342|NCT02631837|183239839|SUPERIORITY|We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
91672343|NCT02631837|183239841|SUPERIORITY||Mean Difference (Final Values)|-555.8||||0.11|TWO_SIDED|95.0||36.0|||Mann-Whitney U test|||||36|-1,044|0.110
91672344|NCT01197417|183239855|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment||Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata||||0.24
91672345|NCT01197417|183239856|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.12
91672346|NCT01197417|183239857|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.39
91672347|NCT01197417|183239858|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||<0.01
91715714|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5747
91792900|NCT03764033|183463295|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|2.43||0.831|TWO_SIDED|95.0|-5.27|4.24||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||4.24|-5.27|0.831
91485506|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.85||||||Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.85|0.53|
91715715|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.6204
91638362|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2535|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.2535
91638363|NCT03781167|183168160|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9274|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.9274
91638364|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3297|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3297
91638365|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9722|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.9722
91638366|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4403|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.4403
91638367|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1946|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.1946
91638368|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2077|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2077
91715716|NCT00549549|183322354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2556|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analysis||||0.2556
91638369|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0692|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0692
91792901|NCT03764033|183463296|SUPERIORITY||Mean Difference (Net)|-6.59|STANDARD_ERROR_OF_MEAN|2.42||0.006|TWO_SIDED|95.0|-11.31|-1.87||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||-1.87|-11.31|0.006
91792902|NCT03764033|183463297|SUPERIORITY||Mean Difference (Net)|-6.54|STANDARD_ERROR_OF_MEAN|2.44||0.008|TWO_SIDED|95.0|-11.34|-1.74||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||-1.74|-11.34|0.008
91638370|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2276|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.2276
91638371|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.3369|||||||paired-sample t-test|||Week 52 vs Baseline||||0.3369
91638372|NCT03781167|183168160|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1218|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1218
91638373|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91638374|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.002|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0020
91638375|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638376|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638377|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
91638378|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
91638379|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638380|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638381|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
91638382|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638383|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638384|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
91638385|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638386|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91715717|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1444|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1444
91715718|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.7532
91715719|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4722|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4722
91715720|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3878|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.3878
91715721|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6717|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.6717
91715722|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3098|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.3098
91485507|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.08||||||Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.08|0.64|
91715723|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4356|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4356
91792903|NCT03764033|183463298|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.066|TWO_SIDED|95.0|-0.37|0.01||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||0.01|-0.37|0.066
91638387|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
91638388|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638389|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638390|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638391|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638392|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638393|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638394|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638395|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91672348|NCT01197417|183239859|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.11
91672349|NCT01197417|183239860|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.78
91672350|NCT01197417|183239861|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.46
91792904|NCT03764033|183463299|SUPERIORITY||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.043|TWO_SIDED|95.0|-0.69|-0.01||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||-0.01|-0.69|0.043
91638396|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638397|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638398|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638399|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638400|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638401|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638402|NCT03781167|183168161|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638403|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638404|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638405|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638406|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638407|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638408|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638409|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638410|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638411|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91672351|NCT01252719|183239864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10%, the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-5.5|4.7||||||||4.7|-5.5|
91715724|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5703|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5703
91715725|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4986
91715726|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.7855
91715727|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0169
91715728|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1353|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.1353
91485508|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.83|1.14||||||Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.83|
91638412|NCT03781167|183168162|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638413|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638414|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638415|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638416|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638417|NCT03781167|183168162|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638418|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638419|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638420|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638421|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638422|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638423|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638424|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638425|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638426|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638427|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638428|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638429|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638430|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638431|NCT03781167|183168163|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638432|NCT03781167|183168163|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91638433|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
91638434|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638435|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
91638436|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0098|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0098
91638437|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638438|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
91638439|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638440|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638441|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
91638442|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638443|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638444|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
91638445|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.003|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0030
91638446|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91672352|NCT01252719|183239865|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% confidence interval (CI) for the difference in response rates in the mITT population was greater than -10% the non-inferiority (NI) of oritavancin to vancomycin was concluded.|Difference in Proportions|3.4|||||TWO_SIDED|95.0|-1.6|8.4||||||||8.4|-1.6|
91672353|NCT01252719|183239866|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10% the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|4.1|||||TWO_SIDED|95.0|-0.5|8.6||||||||8.6|-0.5|
91672354|NCT03135899|183239884|OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.048|0.165|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.165|-0.048|
91672355|NCT03135899|183239884|OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.144|0.07|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.070|-0.144|
91672356|NCT03135899|183239884|OTHER||Mean Difference (Final Values)|-0.157|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|90.0|-0.266|-0.047|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||-0.047|-0.266|
91672357|NCT03135899|183239886|OTHER||Geometric Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.595|0.977|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.977|0.595|
91672358|NCT03135899|183239886|OTHER||Geometric Mean Ratio|0.926|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.715|1.199|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.199|0.715|
91672359|NCT03135899|183239886|OTHER||Geometric Mean Ratio|0.845|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|0.651|1.095|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.095|0.651|
91672360|NCT03135899|183239888|OTHER||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.31|3.95|||Regression, Cox||BI 443651 100 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.95|1.31|
91672361|NCT03135899|183239888|OTHER||Hazard Ratio (HR)|2.08|||||TWO_SIDED|95.0|1.22|3.53|||Regression, Cox||BI 443651 400 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.53|1.22|
91715729|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.3690
91792905|NCT03764033|183463300|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.016|TWO_SIDED|95.0|-0.43|-0.04||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||-0.04|-0.43|0.016
91792906|NCT03764033|183463301|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.028|TWO_SIDED|95.0|-0.74|-0.04||The threshold for statistical significance was p=.05|Mixed Models Analysis|||||-0.04|-0.74|0.028
91526402|NCT00744263|182927967|SUPERIORITY_OR_OTHER||Vaccine Efficacy|75.0||||0.0005|TWO_SIDED|95.0|41.43|90.78|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||90.78|41.43|0.0005
91526403|NCT00744263|182927970|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.979
91526404|NCT00744263|182927971|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.455
91485509|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.0|0.69|
91672362|NCT03135899|183239888|OTHER||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|1.5|4.47|||Regression, Cox||BI 443651 1200 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||4.47|1.50|
91672363|NCT02914236|183239899|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the mean improvement in NOSE score exceeded 15 points||||||<0.0001
91672364|NCT02914236|183239900|SUPERIORITY||||||<|0.0001|||||||binomial test|Success threshold required at least 55% of subjects to be responders||||||<0.0001
91672365|NCT00441350|183239910|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91672366|NCT00441350|183239911|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
91672367|NCT00441350|183239912|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
91672368|NCT00441350|183239913|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
91672369|NCT03614494|183239922|SUPERIORITY||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|26.2|36.4|||Chi-squared|||||36.4|26.2|<0.0001
91672370|NCT03614494|183239923|SUPERIORITY||Odds Ratio (OR)|0.197||||0.036|TWO_SIDED|95.0|0.021|0.906|||Logistic regression, Firth's bias reduct|||||0.906|0.021|0.036
91672371|NCT02129647|183239928|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 122 (60 to 265)|||
91672372|NCT02129647|183239929|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 135 (100 to 240)|||
91672373|NCT02129647|183239930|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 12 (0 to 100)|||
91672374|NCT01715896|183239936|SUPERIORITY_OR_OTHER||Percent difference|-3.5||||0.666|TWO_SIDED|90.0|-16.8|9.8|||Logit response Model||P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.|||9.8|-16.8|0.666
91672375|NCT01715896|183239937|SUPERIORITY_OR_OTHER||Percent difference|-8.6||||0.293|TWO_SIDED|90.0|-22.0|4.8|||Logit response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||4.8|-22.0|0.293
91672376|NCT01715896|183239938|SUPERIORITY_OR_OTHER||Percent difference|-9.8||||0.156|TWO_SIDED|90.0|-21.1|1.4|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||1.4|-21.1|0.156
91672377|NCT01715896|183239939|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108|TWO_SIDED|90.0|-23.2|0.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||0.0|-23.2|0.108
91526405|NCT04078035|182927985|SUPERIORITY||Slope|-0.00015|STANDARD_ERROR_OF_MEAN|0.00088||0.86|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.86
91672378|NCT01715896|183239940|SUPERIORITY_OR_OTHER||Percent difference|-10.3||||0.208|TWO_SIDED|90.0|-23.7|3.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||3.0|-23.7|0.2080
91672379|NCT01715896|183239947|SUPERIORITY_OR_OTHER||Adjusted Mean difference|-7.42||||0.213|TWO_SIDED|90.0|-17.24|2.4|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.|||2.40|-17.24|0.213
91672380|NCT01715896|183239949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.129|TWO_SIDED|90.0|0.36|1.04|||Proportional odds analysis||Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.|||1.04|0.36|0.129
91672381|NCT01715896|183239950|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108||90.0|-23.2|0.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||0.0|-23.2|0.108
91672382|NCT01715896|183239950|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.145|TWO_SIDED|90.0|-24.8|1.4|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|The analysis reported DAS28 (CRP) low disease activity response.||1.4|-24.8|0.145
91672383|NCT01715896|183239951|SUPERIORITY_OR_OTHER|||||||0.328|||||||Log Rank|P-value was calculated using the Log rank test.||||||0.328
91672384|NCT01715896|183239952|SUPERIORITY_OR_OTHER|||||||0.003|||||||Weibull model|P-value was calculated using an Weibull model.||||||0.003
91672385|NCT01715896|183239953|SUPERIORITY_OR_OTHER||Percent difference|-1.7||||0.795|TWO_SIDED|90.0|-12.4|9.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||9.0|-12.4|0.795
91672386|NCT01715896|183239954|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.048|TWO_SIDED|90.0|-21.0|-2.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-2.5|-21.0|0.048
91672387|NCT01715896|183239955|SUPERIORITY_OR_OTHER||Percent difference|-11.9||||0.035|TWO_SIDED|90.0|-20.6|-3.1|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-3.1|-20.6|0.035
91672388|NCT01715896|183239956|SUPERIORITY_OR_OTHER||Percent difference|-7.5||||0.061|TWO_SIDED|90.0|-13.6|-1.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-1.5|-13.6|0.061
91715730|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0787|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0787
91485510|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.62|0.92||||||Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.92|0.62|
91485511|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.06||||||Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.06|0.64|
91638447|NCT03781167|183168164|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
91672389|NCT01715896|183239957|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.993|TWO_SIDED|90.0|-1.33|1.32|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in swollen joint count at Day 169.||1.32|-1.33|0.993
91485512|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.04|0.72|
91526406|NCT04078035|182927986|SUPERIORITY||Slope|0.00022|STANDARD_ERROR_OF_MEAN|0.00067||0.74|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results present the condition (stress/control) by time interactions.||||0.74
91638448|NCT00679354|183168180|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.0||||1|TWO_SIDED||||||Spearman's Correlation|||||||1.000
91638449|NCT00679354|183168181|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.56||||0.057|TWO_SIDED||||||Spearman's Correlation|||||||0.057
91638450|NCT00679354|183168182|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.22||||0.495|TWO_SIDED||||||Spearman's Correlation|||||||0.495
91638451|NCT00679354|183168183|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.48||||0.114|TWO_SIDED||||||Spearman's Correlation|||||||0.114
91638452|NCT01258803|183168191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.094|0.154|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.154|0.094|<0.001
91638453|NCT01258803|183168192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.073|0.131|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.131|0.073|<0.001
91672390|NCT01715896|183239957|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.23||||0.424|TWO_SIDED|90.0|-1.31|3.77|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in Tender joint count at Day 169.||3.77|-1.31|0.424
91672391|NCT01715896|183239958|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89||||0.272|TWO_SIDED|90.0|-2.46|12.24|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||12.24|-2.46|0.272
91715731|NCT00549549|183322355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5687
91638454|NCT01258803|183168193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022||||0.144|TWO_SIDED|95.0|-0.008|0.052|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.052|-0.008|0.144
91638455|NCT01258803|183168195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.018||||0.229|TWO_SIDED|95.0|-0.012|0.048|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.048|-0.012|0.229
91638456|NCT01258803|183168196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.004||||0.79|TWO_SIDED|95.0|-0.033|0.025|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.025|-0.033|0.790
91672392|NCT01715896|183239959|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.46||||0.319|TWO_SIDED|90.0|-2.92|11.84|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||11.84|-2.92|0.319
91672393|NCT01715896|183239960|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.16||||0.64|TWO_SIDED|90.0|-0.42|0.74|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.74|-0.42|0.640
91715732|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||-0.10|-0.60|
91638457|NCT01258803|183168197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|||<|0.001|TWO_SIDED|95.0|0.077|0.135|||ANCOVA|||"Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.135|0.077|<0.001
91638458|NCT01632345|183168228|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|6.7|||||TWO_SIDED|95.0|-9.0|22.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||22.4|-9.0|
91638459|NCT01632345|183168228|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|9.7|||||TWO_SIDED|95.0|-4.6|24.9|||||A negative value would be considered as favoring doravirine over efavirenz.|||24.9|-4.6|
91672394|NCT01715896|183239961|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.18||||0.055|TWO_SIDED|90.0|0.03|0.34|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.34|0.03|0.055
91672395|NCT01715896|183239962|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.06||||0.752|TWO_SIDED|90.0|0.79|1.41|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.41|0.79|0.752
91672396|NCT01715896|183239963|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05||||0.725|TWO_SIDED|90.0|0.84|1.3|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.30|0.84|0.725
91672397|NCT01045993|183239972|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
91672398|NCT01045993|183239973|NON_INFERIORITY_OR_EQUIVALENCE|The statistical alternative hypothesis tested is that the survival curves of time to first perceptible relief confirmed by meaningful relief are not identical between two treatment groups, or equivalently, the hazard ratio between two treatment groups is not equal to 1.||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
91672399|NCT01045993|183239974|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using analysis of variance (ANOVA) model with treatment term only in the model.||||||<0.001
91672400|NCT01045993|183239975|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using ANOVA model with treatment term only in the model.||||||0.002
91672401|NCT01045993|183239977|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
91485513|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.14||||||Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.71|
91526407|NCT04078035|182927987|SUPERIORITY||Slope|-0.0012|STANDARD_ERROR_OF_MEAN|0.0019||0.52|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.52
91638460|NCT01632345|183168228|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-11.9|||||TWO_SIDED|95.0|-27.9|6.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.3|-27.9|
91638461|NCT01632345|183168228|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.0|||||TWO_SIDED|95.0|-14.5|18.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||18.4|-14.5|
91638462|NCT01632345|183168229|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.3|||||TWO_SIDED|95.0|-13.7|8.8|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.8|-13.7|
91638463|NCT01632345|183168229|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.2|||||TWO_SIDED|95.0|-9.9|14.7|||||A negative value would be considered as favoring doravirine over efavirenz.|||14.7|-9.9|
91638464|NCT01632345|183168229|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.4|||||TWO_SIDED|95.0|-13.8|8.2|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.2|-13.8|
91638465|NCT01632345|183168229|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-4.8|||||TWO_SIDED|95.0|-15.9|4.1|||||A negative value would be considered as favoring doravirine over efavirenz.|||4.1|-15.9|
91638466|NCT01632345|183168230|SUPERIORITY_OR_OTHER||Difference|-10.2|||||TWO_SIDED|95.0|-20.9|0.5|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.5|-20.9|
91638467|NCT01632345|183168231|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.4|-7.8||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.8|-32.4|0.002
91672402|NCT01045993|183239977|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.016
91672403|NCT01045993|183239977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||<0.001
91715733|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.75|-0.25|||ANCOVA|||Day 1 analyses||-0.25|-0.75|
91715734|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.29|0.78|||ANCOVA|||Day 1 analyses||0.78|0.29|
91715735|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.06|0.44|||ANCOVA|||Day 1 analyses||0.44|-0.06|
91715736|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.21|0.28|||ANCOVA|||Day 1 analyses||0.28|-0.21|
91715737|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||Day 2 analyses||0.04|-0.52|
91715738|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||Day 2 analyses||-0.18|-0.74|
91715739|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||Day 2 analyses||0.84|0.29|
91715740|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||Day 2 analyses||0.60|0.05|
91715741|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||Day 2 analyses||0.39|-0.17|
91715742|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.53|0.03|||ANCOVA|||Day 3 analyses||0.03|-0.53|
91715743|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.83|-0.26|||ANCOVA|||Day 3 analyses||-0.26|-0.83|
91715744|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.32|0.88|||ANCOVA|||Day 3 analyses||0.88|0.32|
91715745|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Day 3 analyses||0.64|0.08|
91715746|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.22|0.34|||ANCOVA|||Day 3 analyses||0.34|-0.22|
91715747|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Day 4 analyses||-0.00|-0.56|
91715748|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.28|||ANCOVA|||Day 4 analyses||-0.28|-0.84|
91715749|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.35|0.9|||ANCOVA|||Day 4 analyses||0.90|0.35|
91715750|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Day 4 analyses||0.62|0.07|
91715751|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Day 4 analyses||0.34|-0.21|
91715752|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|||Day 5 analyses||-0.07|-0.64|
91715753|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.94|-0.38|||ANCOVA|||Day 5 analyses||-0.38|-0.94|
91715754|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.37|0.93|||ANCOVA|||Day 5 analyses||0.93|0.37|
91715755|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.02|0.57|||ANCOVA|||Day 5 analyses||0.57|0.02|
91715756|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.29|0.27|||ANCOVA|||Day 5 analyses||0.27|-0.29|
91715757|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.65|-0.1|||ANCOVA|||Day 6 analyses||-0.10|-0.65|
91715758|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.29|||ANCOVA|||Day 6 analyses||-0.29|-0.84|
91485514|NCT02124161|182844158|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.03||||||Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.03|0.56|
91715759|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.83|||ANCOVA|||Day 6 analyses||0.83|0.29|
91715760|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.08|0.46|||ANCOVA|||Day 6 analyses||0.46|-0.08|
91715761|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Day 6 analyses||0.26|-0.28|
91715762|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Day 7 analyses||-0.04|-0.61|
91715763|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Day 7 analyses||-0.34|-0.92|
91715764|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.21|0.78|||ANCOVA|||Day 7 analyses||0.78|0.21|
91715765|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.45|||ANCOVA|||Day 7 analyses||0.45|-0.11|
91715766|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.15|||ANCOVA|||Day 7 analyses||0.15|-0.42|
91715767|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Day 8 analyses||-0.00|-0.57|
91715768|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.27|||ANCOVA|||Day 8 analyses||-0.27|-0.84|
91715769|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.14|0.7|||ANCOVA|||Day 8 analyses||0.70|0.14|
91638468|NCT01632345|183168232|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.6|-7.5||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.5|-32.6|0.002
91638469|NCT01632345|183168233|SUPERIORITY_OR_OTHER||Difference in % response|15.7|||||TWO_SIDED|95.0|-4.1|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-4.1|
91638470|NCT01632345|183168233|SUPERIORITY_OR_OTHER||Difference in % response|10.0|||||TWO_SIDED|95.0|-9.6|29.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||29.1|-9.6|
91672404|NCT01045993|183239977|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.002
91672405|NCT01045993|183239977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||<0.001
91672406|NCT01045993|183239977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||<0.001
91672407|NCT01045993|183239977|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.003
91672408|NCT01045993|183239977|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.001
91715770|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.15|0.41|||ANCOVA|||Day 8 analyses||0.41|-0.15|
91485515|NCT02124161|182844159|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.18||||||Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.88|
91638471|NCT01632345|183168233|SUPERIORITY_OR_OTHER||Difference in % response|6.6|||||TWO_SIDED|95.0|-13.2|26.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||26.0|-13.2|
91672409|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
91672410|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.002
91672411|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||0.033
91672412|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.096
91672413|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||0.002
91715771|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.14|||ANCOVA|||Day 8 analyses||0.14|-0.42|
91638472|NCT01632345|183168233|SUPERIORITY_OR_OTHER||Difference in % response|15.9|||||TWO_SIDED|95.0|-3.4|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-3.4|
91638473|NCT01632345|183168234|SUPERIORITY_OR_OTHER||Difference in % response|-0.5|||||TWO_SIDED|95.0|-13.2|11.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.2|-13.2|
91638474|NCT01632345|183168235|SUPERIORITY_OR_OTHER||Difference in % response|-1.9|||||TWO_SIDED|95.0|-12.9|9.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.2|-12.9|
91638475|NCT01632345|183168236|SUPERIORITY_OR_OTHER||Difference in % response|-0.8|||||TWO_SIDED|95.0|-12.4|10.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||10.7|-12.4|
91638476|NCT01632345|183168237|SUPERIORITY_OR_OTHER||Difference in % response|4.5|||||TWO_SIDED|95.0|-12.5|21.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||21.5|-12.5|
91638477|NCT01632345|183168237|SUPERIORITY_OR_OTHER||Difference in % response|2.8|||||TWO_SIDED|95.0|-13.9|19.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||19.8|-13.9|
91638478|NCT01632345|183168237|SUPERIORITY_OR_OTHER||Difference in % response|12.2|||||TWO_SIDED|95.0|-2.5|28.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||28.0|-2.5|
91638479|NCT01632345|183168237|SUPERIORITY_OR_OTHER||Difference in % response|9.5|||||TWO_SIDED|95.0|-6.2|25.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||25.7|-6.2|
91672414|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||0.005
91715772|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.02|||ANCOVA|||Day 9 analyses||-0.02|-0.61|
91715773|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.82|-0.23|||ANCOVA|||Day 9 analyses||-0.23|-0.82|
91792907|NCT04594369|183463302|SUPERIORITY||Rate ratio|0.789|||=|0.0019|TWO_SIDED|95.0|0.68|0.916||Adjusted p-value = 0.0038. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the primary endpoint was tested at two-sided alpha = 0.01.|Negative binomial regression|||Model treatment \& randomization stratification factor=geographic region, sputum sample (Pseudomonas aeruginosa) at start \& PE last 12 months, age group (fixed effects) \& time at risk (log scale) as offset variable. Robust sandwich covariance estimator used.||0.916|0.680|=0.0019
91792908|NCT04594369|183463302|SUPERIORITY||Rate ratio|0.806|||=|0.0046|TWO_SIDED|95.0|0.694|0.936||Adjusted p-value = 0.0048. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the primary endpoint was tested at two-sided alpha = 0.01.|Negative binomial regression|||Model treatment \& randomization stratification factor=geographic region, sputum sample (Pseudomonas aeruginosa) at start \& PE last 12 months, age group (fixed effects) \& time at risk (log scale) as offset variable. Robust sandwich covariance estimator used.||0.936|0.694|=0.0046
91792909|NCT04594369|183463303|SUPERIORITY||Hazard Ratio (HR)|0.813|||=|0.01|TWO_SIDED|95.0|0.695|0.952||Adjusted p-value = 0.0200. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.|Cox proportional hazard|||Estimate of Cox proportional hazard model=effect for treatment, sputum sample for Pseudomonas aeruginosa at screening and PE \[\<3 or ≥3\] in last 12 months, stratification region and age group. Robust sandwich covariance estimator used.||0.952|0.695|=0.01
91638480|NCT01632345|183168238|SUPERIORITY_OR_OTHER||Difference in % response|2.7||||||95.0|-6.1|11.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.7|-6.1|
91638481|NCT01632345|183168239|SUPERIORITY_OR_OTHER||Difference in % response|0.1|||||TWO_SIDED|95.0|-9.7|9.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.9|-9.7|
91638482|NCT01632345|183168240|SUPERIORITY_OR_OTHER||Difference in % response|3.9|||||TWO_SIDED|95.0|-7.3|15.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||15.0|-7.3|
91638483|NCT01632345|183168241|SUPERIORITY_OR_OTHER||Difference in CD4 change|33.0|||||TWO_SIDED|95.0|-28.1|94.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||94.0|-28.1|
91638484|NCT01632345|183168241|SUPERIORITY_OR_OTHER||Difference in CD4 change|-8.3|||||TWO_SIDED|95.0|-68.5|51.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||51.9|-68.5|
91638485|NCT01632345|183168241|SUPERIORITY_OR_OTHER||Difference in CD4 change|12.5|||||TWO_SIDED|95.0|-44.6|69.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||69.5|-44.6|
91638486|NCT01632345|183168241|SUPERIORITY_OR_OTHER||Difference in CD4 change|19.6|||||TWO_SIDED|95.0|-45.1|84.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||84.2|-45.1|
91715774|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.18|0.76|||ANCOVA|||Day 9 analyses||0.76|0.18|
91638487|NCT01632345|183168242|SUPERIORITY_OR_OTHER||Difference in CD4 change|6.3|||||TWO_SIDED|95.0|-38.2|50.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||50.8|-38.2|
91638488|NCT01632345|183168243|SUPERIORITY_OR_OTHER||Difference in CD4 change|-2.6|||||TWO_SIDED|95.0|-46.5|41.3|||||A positive value would be considered as favoring doravirine over efavirenz.|||41.3|-46.5|
91638489|NCT01632345|183168244|SUPERIORITY_OR_OTHER||Difference in CD4 change|-4.4|||||TWO_SIDED|95.0|-64.0|55.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||55.1|-64.0|
91638490|NCT01632345|183168245|SUPERIORITY_OR_OTHER||Difference|-2.8|||||TWO_SIDED|95.0|-11.7|6.0|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.0|-11.7|
91638491|NCT01632345|183168246|SUPERIORITY_OR_OTHER||Difference|-6.5|||||TWO_SIDED|95.0|-14.1|0.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.3|-14.1|
91638492|NCT00089505|183168252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.69|||<|0.001|TWO_SIDED|95.0|1.79|7.61||P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Regression, Cox|The model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm\^3).|The HR is for NVP/NVP vs. NVP/LPV\_r.|||7.61|1.79|<0.001
91638493|NCT00089505|183168253|NON_INFERIORITY_OR_EQUIVALENCE|NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV\_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.|Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.56|1.29||P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.|Regression, Cox|The cox proportional hazard model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm3).|The HR is for NoNVP/NVP vs. NoNVP/LPV\_r.|||1.29|0.56|0.43
91638494|NCT05047601|183168275|SUPERIORITY||Risk Ratio (RR)|0.702||||0.1722|TWO_SIDED|95.0|0.422|1.167|||Generalized estimating equation (GEE)|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.167|0.422|0.1722
91638495|NCT05047601|183168275|SUPERIORITY||Risk Ratio (RR)|0.645||||0.1163|TWO_SIDED|95.0|0.373|1.115|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.115|0.373|0.1163
91638496|NCT05047601|183168277|SUPERIORITY||Risk Ratio (RR)|0.88||||0.6766|TWO_SIDED|95.0|0.484|1.602|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.602|0.484|0.6766
91638497|NCT05047601|183168277|SUPERIORITY||Risk Ratio (RR)|0.809||||0.507|TWO_SIDED|95.0|0.433|1.512|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.512|0.433|0.5070
91715775|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.13|0.44|||ANCOVA|||Day 9 analyses||0.44|-0.13|
91715776|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Day 9 analyses||0.23|-0.35|
91792910|NCT04594369|183463303|SUPERIORITY||Hazard Ratio (HR)|0.825|||=|0.0182|TWO_SIDED|95.0|0.703|0.968||Adjusted p-value = 0.0364. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.|Cox proportional hazard|||Estimate of Cox proportional hazard model=effect for treatment, sputum sample for Pseudomonas aeruginosa at screening and PE \[\<3 or ≥3\] in last 12 months, stratification region and age group. Robust sandwich covariance estimator used.||0.968|0.703|=0.0182
91485516|NCT02124161|182844159|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.2|||||TWO_SIDED|95.0|1.01|1.32||||||Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.32|1.01|
91638498|NCT05047601|183168279|SUPERIORITY||Risk Ratio (RR)|0.672||||0.1869|TWO_SIDED|95.0|0.373|1.213|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.213|0.373|0.1869
91638499|NCT05047601|183168279|SUPERIORITY||Risk Ratio (RR)|0.633||||0.1221|TWO_SIDED|95.0|0.355|1.13|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.130|0.355|0.1221
91638500|NCT05047601|183168280|SUPERIORITY|||||||0.0368|||||||Log Rank|||||||0.0368
91638501|NCT05047601|183168280|SUPERIORITY|||||||0.0186|||||||Log Rank|||||||0.0186
91672415|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.008
91672416|NCT01045993|183239978|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.004
91672417|NCT01045993|183239979|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.268
91672418|NCT01045993|183239979|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.419
91672419|NCT01045993|183239979|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.086
91638502|NCT05047601|183168281|SUPERIORITY||Risk Ratio (RR)|0.75||||0.4126|TWO_SIDED|95.0|0.378|1.491|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.491|0.378|0.4126
91672420|NCT01045993|183239980|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.067
91672421|NCT01045993|183239980|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.757
91672422|NCT01045993|183239980|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.219
91672423|NCT01045993|183239981|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.043
91638503|NCT05047601|183168281|SUPERIORITY||Risk Ratio (RR)|1.244||||0.4273|TWO_SIDED|95.0|0.725|2.135|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||2.135|0.725|0.4273
91638504|NCT05047601|183168282|SUPERIORITY||Risk Ratio (RR)|0.726||||0.1333|TWO_SIDED|95.0|0.478|1.103|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.103|0.478|0.1333
91638505|NCT05047601|183168282|SUPERIORITY||Risk Ratio (RR)|0.953||||0.8088|TWO_SIDED|95.0|0.645|1.408|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.408|0.645|0.8088
91638506|NCT05047601|183168290|SUPERIORITY||LS Mean Ratio|0.969||||0.7991|TWO_SIDED|95.0|0.758|1.238|||Negative binomial regression model|||||1.238|0.758|0.7991
91638507|NCT05047601|183168290|SUPERIORITY||LS Mean Ratio|0.847||||0.1985|TWO_SIDED|95.0|0.657|1.091|||Negative binomial regression model|||||1.091|0.657|0.1985
91638508|NCT02924129|183168307|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||Significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
91638509|NCT02924129|183168308|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|9.0|||<|0.001|TWO_SIDED|95.0|-2.4|20.4||significance threshold (α) of 0.05|t-test, 2 sided|||||20.4|-2.4|<0.001
91638510|NCT02924129|183168309|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|14.6|||<|0.001|TWO_SIDED|95.0|2.9|26.3||significance threshold (α) of 0.05|t-test, 2 sided|||||26.3|2.9|<0.001
91638511|NCT02924129|183168310|NON_INFERIORITY|non-inferiority margin (δ) of 10%||||||0.002||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||0.002
91672424|NCT01045993|183239981|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.388
91792911|NCT04594369|183463304|SUPERIORITY||Odds Ratio (OR)|1.412|||=|0.0059|TWO_SIDED|95.0|1.105|1.806||Adjusted p-value = 0.0200. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.|Logistic Regression|||Missing responder status was imputed 100 times. Dataset was analyzed via logistic regression with treatment group, sputum P. aeruginosa status, prior PEs (\<3/≥3), region, and age group as fixed effects. Results were then combined using Rubin's rules.||1.806|1.105|=0.0059
91792912|NCT04594369|183463304|SUPERIORITY||Odds Ratio (OR)|1.4|||=|0.0074|TWO_SIDED|95.0|1.095|1.792||Adjusted p-value = 0.0364. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.|Logistic Regression|||Missing responder status was imputed 100 times. Dataset was analyzed via logistic regression with treatment group, sputum P. aeruginosa status, prior PEs (\<3/≥3), region, and age group as fixed effects. Results were then combined using Rubin's rules.||1.792|1.095|=0.0074
91672425|NCT01045993|183239981|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.039
91672426|NCT01045993|183239982|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.797
91672427|NCT01045993|183239983|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.371
91672428|NCT01045993|183239984|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.122
91672429|NCT01045993|183239985|SUPERIORITY_OR_OTHER|||||||0.355||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.355
91672430|NCT01045993|183239985|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.371
91672431|NCT01045993|183239985|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-values from ANOVA model with treatment treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.216
91672432|NCT01045993|183239986|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.054
91672433|NCT01045993|183239986|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.600
91672434|NCT01045993|183239986|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.294
91526408|NCT04078035|182927988|SUPERIORITY|Results present the condition (stress/control) by time\^2 interactions.|Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||||||<.001
91672435|NCT01045993|183239987|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.088
91672436|NCT01045993|183239987|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.625
91672437|NCT01045993|183239987|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.034
91672438|NCT01045993|183239988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Cochran-Mantel-Haenszel|P-value from the Cochran-Mantel-Haenszel test with modified ridit scores.||||||<0.001
91672439|NCT01659736|183239989|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||p-value is for the condition (active TMS versus Sham) by time (pre, post, 3-month follow-up) interaction|ANOVA|||||||0.006
91715777|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.59|0.01|||ANCOVA|||Day 10 analyses||0.01|-0.59|
91672440|NCT00474851|183239999|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10|RMANOVA|||"Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.10
91715778|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.76|-0.16|||ANCOVA|||Day 10 analyses||-0.16|-0.76|
91638512|NCT02924129|183168311|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
91638513|NCT02924129|183168312|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
91638514|NCT02924129|183168313|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|10.7|||<|0.001|TWO_SIDED|95.0|-1.8|23.3||significance threshold (α) of 0.05|t-test, 2 sided|||||23.3|-1.8|<0.001
91672441|NCT00474851|183240000|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02|RMANOVA|||"The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.02
91672442|NCT03478865|183240005|SUPERIORITY||Mean Difference (Final Values)|-2.54||||0.259|TWO_SIDED|95.0|-7.91|2.83||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||2.83|-7.91|0.259
91672443|NCT03478865|183240005|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.818|TWO_SIDED|95.0|-4.66|4.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||4.12|-4.66|0.818
91672444|NCT03478865|183240006|SUPERIORITY||Mean Difference (Final Values)|-3.56||||0.365|TWO_SIDED|95.0|-13.24|6.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||6.12|-13.24|0.365
91715779|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 10 analyses||0.69|0.10|
91485517|NCT02124161|182844159|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.24||||||Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.24|0.95|
91672445|NCT03478865|183240006|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.48|TWO_SIDED|95.0|-12.94|19.41||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||19.41|-12.94|0.480
91672446|NCT02296853|183240025|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|54.04|||||TWO_SIDED|90.0|41.98|69.56|||||Here, GLSM is geometric least square mean.|TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||69.56|41.98|
91672447|NCT02296853|183240025|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|63.06|||||TWO_SIDED|90.0|42.9|92.7||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||92.70|42.90|
91638515|NCT02924129|183168314|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|2.5|28.3||significance threshold (α) of 0.05|t-test, 2 sided|||||28.3|2.5|<0.001
91638516|NCT02924129|183168315|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001|||||||normal approximation to the binomial|||||||<0.001
91672448|NCT02296853|183240025|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|94.42|||||TWO_SIDED|90.0|72.48|122.99||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||122.99|72.48|
91715780|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.18|0.41|||ANCOVA|||Day 10 analyses||0.41|-0.18|
91715781|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.23|||ANCOVA|||Day 10 analyses||0.23|-0.36|
91638517|NCT02924129|183168316|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
91638518|NCT02780869|183168327|NON_INFERIORITY|The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™- G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ \> -0.10 using a one-sided level 0.025 test.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.||||||<0.0001
91715782|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Day 11 analyses||0.05|-0.56|
91715783|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.77|-0.17|||ANCOVA|||Day 11 analyses||-0.17|-0.77|
91485518|NCT02124161|182844159|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.21||||||Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.21|0.90|
91672449|NCT02296853|183240026|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|45.1|||||TWO_SIDED|90.0|31.66|64.25||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||64.25|31.66|
91672450|NCT02296853|183240026|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|89.88|||||TWO_SIDED|90.0|64.77|124.72||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||124.72|64.77|
91672451|NCT02296853|183240026|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|82.16|||||TWO_SIDED|90.0|56.58|119.31||"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.31|56.58|
91672452|NCT02296853|183240027|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|51.2|||||TWO_SIDED|90.0|40.11|65.36||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||65.36|40.11|
91672453|NCT02296853|183240027|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|62.04|||||TWO_SIDED|90.0|41.92|91.82||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||91.82|41.92|
91672454|NCT02296853|183240027|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|93.28|||||TWO_SIDED|90.0|72.62|119.8||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.8|72.62|
91672455|NCT01352182|183240032|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91715784|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 11 analyses||0.69|0.10|
91485519|NCT02124161|182844162|SUPERIORITY_OR_OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.9|7.4||||||AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||7.4|-1.9|
91485520|NCT02124161|182844162|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||1.7|-1.8|
91672456|NCT01352182|183240033|SUPERIORITY|||||||1||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||1.0
91672457|NCT01352182|183240034|SUPERIORITY|||||||0.154||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.154
91672458|NCT01352182|183240035|SUPERIORITY|||||||0.683||||||significance threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.683
91715785|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.16|0.44|||ANCOVA|||Day 11 analyses||0.44|-0.16|
91672459|NCT01352182|183240036|SUPERIORITY|||||||0.08||||||significance threshold p\<0.05|t-test, 2 sided|||||||0.08
91672460|NCT01352182|183240037|OTHER|linear regression|Slope|-1.44|STANDARD_ERROR_OF_MEAN|0.3741||0.003|TWO_SIDED||||||Regression, Linear|||||||0.003
91672461|NCT02740179|183240046|SUPERIORITY|||||||0.72||||||P value for Change in Coronary Flow Reserve on Cardiac PET|t-test, 2 sided|||||||0.72
91672462|NCT02740179|183240047|SUPERIORITY|||||||0.03||||||P value for Change in Stress Myocardial Blood Flow on Cardiac MRI|t-test, 2 sided|||||||0.03
91672463|NCT02740179|183240048|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
91672464|NCT02740179|183240049|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
91672465|NCT02740179|183240050|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Analyses performed on log transformation of data||||||0.03
91715786|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.37|0.23|||ANCOVA|||Day 11 analyses||0.23|-0.37|
91715787|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Day 12 analyses||0.09|-0.53|
91715788|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Day 12 analyses||-0.15|-0.77|
91715789|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.04|0.57|||ANCOVA|||Day 12 analyses||0.57|-0.04|
91715790|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.25|0.36|||ANCOVA|||Day 12 analyses||0.36|-0.25|
91638519|NCT02780869|183168327|SUPERIORITY|||||||0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Cochran-Mantel-Haenszel|||A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.||||0.0001
91638520|NCT02780869|183168328|SUPERIORITY||||||<|0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Regression, Linear|||The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.||||<0.0001
91638521|NCT02780869|183168329|NON_INFERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.|||||<|0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||<0.0001
91638522|NCT02780869|183168329|SUPERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.||||||0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||0.0001
91638523|NCT03702166|183168365|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|Multiple t-tests with Bonferroni corrections for multiple comparisons||||||0.01
91638524|NCT03702166|183168367|SUPERIORITY|||||||0.038|||||||t-test, 1 sided|Multiple t-tests, with Bonferroni corrections for multiple comparisons,||||||0.038
91638525|NCT03702166|183168369|SUPERIORITY|||||||0.031||||||Multiple t-tests, with Bonferroni corrections for multiple comparisons|t-test, 1 sided|||||||0.031
91638526|NCT03512028|183168373|SUPERIORITY||Mean Difference (Net)|3.2||||0.002|TWO_SIDED|||||Interaction effect of group x time from pre- to post- intervention|ANOVA||Estimated difference between slopes|Mixed model ANOVA with group (RLIC, Sham) and time (pre-, post-, and follow-up ). The main analysis of interest is the group x time interaction from pre- to post-.||||0.002
91638527|NCT03512028|183168373|SUPERIORITY|||||||0.001||||||Main effect of time|ANOVA|||||||0.001
91638528|NCT03512028|183168373|SUPERIORITY|||||||0.844||||||Main effect of group|ANOVA|||||||0.844
91638529|NCT03245372|183168374|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
91672466|NCT02740179|183240051|SUPERIORITY|||||||0.09||||||P value for Change in Plasma IL-6|t-test, 2 sided|Analyses performed after log transformation of data||||||0.09
91485521|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-2.8||||0.333|TWO_SIDED|95.0|-8.3|2.8|||Chan and Zhang method|||Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.8|-8.3|0.333
91638530|NCT03245372|183168375|SUPERIORITY|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.692
91638531|NCT03245372|183168376|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
91638532|NCT03245372|183168377|SUPERIORITY|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
91638533|NCT03245372|183168378|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||0.668
91638534|NCT03245372|183168379|SUPERIORITY|||||||0.516|||||||Chi-squared|||||||0.516
91638535|NCT03245372|183168381|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
91638536|NCT03245372|183168382|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91638537|NCT04047342|183168383|SUPERIORITY||Odds Ratio (OR)|0.97||||0.828|TWO_SIDED|95.0|0.72|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.30|0.72|.828
91638538|NCT00660829|183168387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5633|STANDARD_DEVIATION|0.3345|<|0.001||95.0|-2.22|-0.91|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.91|-2.22|<0.001
91638539|NCT00660829|183168388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7444|STANDARD_ERROR_OF_MEAN|0.1677|<|0.001||95.0|-1.07|-0.42|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.42|-1.07|<0.001
91638540|NCT00660829|183168389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4403|STANDARD_DEVIATION|0.3406|<|0.001||95.0|-2.11|-0.77|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.77|-2.11|<0.001
91638541|NCT00660829|183168390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2907|STANDARD_DEVIATION|0.3204|<|0.001||95.0|-1.92|0.66|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||0.66|-1.92|<0.001
91638542|NCT00660829|183168391|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||Change from baseline||||0.001
91638543|NCT02127931|183168398|OTHER|||||||0.005|||||||Correlation|||ADHD-I||||0.005
91638544|NCT02127931|183168398|OTHER|||||||0.023|||||||Correlation|||ADHD-C||||0.023
91638545|NCT02127931|183168399|OTHER|||||||0.013|||||||Correlation|||||||0.013
91638546|NCT02028182|183168407|OTHER||Kappa statistic-Concordance 0.4 mg/cm2|75.0|||||TWO_SIDED|95.0|60.4|94.0||||||||94.0|60.4|
91638547|NCT02028182|183168407|OTHER||Kappa statistic: Concordance 0.20 mg/cm2|65.0|||||TWO_SIDED|95.0|55.6|90.4||||||||90.4|55.6|
91638548|NCT02028182|183168407|OTHER||Kappa statistic: Concordance0.10 mg/cm2|60.0|||||TWO_SIDED|95.0|53.3|88.4||||||||88.4|53.3|
91638549|NCT01336647|183168423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size\>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher's Exact test was used to compare treatment arms, instead of the CMH test.|||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|The assessment of statistical significance will be done using Hochberg's modified Bonferroni test.||Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison||||<0.001
91672467|NCT02740179|183240052|SUPERIORITY|||||||0.36||||||P value for Change in Plasma hsCRP|t-test, 2 sided|Analyses performed after log transformation of data||||||0.36
91672468|NCT02740179|183240053|SUPERIORITY|||||||0.88||||||P value for Change in Plasma MCP-1|t-test, 2 sided|Analyses performed after log transformation of data||||||0.88
91672469|NCT02740179|183240054|SUPERIORITY|||||||0.17||||||P value for Change in Plasma sCD163|t-test, 2 sided|Analyses performed after log transformation of data||||||0.17
91715791|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Day 12 analyses||0.11|-0.50|
91672470|NCT02740179|183240055|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|Analyses performed after log transformation of data||||||0.28
91672471|NCT02740179|183240056|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
91672472|NCT02740179|183240057|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91672473|NCT02740179|183240058|SUPERIORITY|||||||0.73|||||||Kruskal-Wallis|||||||0.73
91672474|NCT02740179|183240059|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
91672475|NCT02740179|183240060|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|||||||0.03
91672476|NCT02740179|183240061|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91672477|NCT01192399|183240087|OTHER||||||<|0.0001|||||||Sign test|||||||<0.0001
91672478|NCT02377063|183240097|OTHER||Mean Difference (Final Values)|-11.2||||0.014|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumption||||0.014
91792913|NCT04594369|183463305|SUPERIORITY||Difference in Least square (LS) Mean|0.011|STANDARD_ERROR_OF_MEAN|0.0132|=|0.3841|TWO_SIDED|95.0|-0.014|0.037||Adjusted p-value = 0.3841. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.|Linear repeated measures model|||Analysis on linear repeated measure model=treatment visit, sputum sample for Pseudomonas aeruginosa at start, PE \[\<3 or ≥3\] last 12 months, stratification region, age group (fixed effect) \& baseline (covariate). Robust sandwich covariance estimator used.||0.037|-0.014|=0.3841
91672479|NCT02377063|183240097|OTHER||Mean Difference (Final Values)|10.5||||0.026|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumption||||0.026
91672480|NCT02723773|183240102|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.77|||||TWO_SIDED|95.0|73.72|84.61|||Poisson regression method||VE=1 - the relative risk (RR). RR=the ratio of the incidence rates of LTFU+Control \>=50YOA Group over Historical Control \>=50YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||84.61|73.72|
91672481|NCT02723773|183240103|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|75.55|93.36|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||93.36|75.55|
91672482|NCT02723773|183240103|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.14|||||TWO_SIDED|95.0|74.17|94.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||94.35|74.17|
91672483|NCT02723773|183240103|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|77.11|||||TWO_SIDED|95.0|69.37|83.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||83.14|69.37|
91672484|NCT02723773|183240103|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.18|||||TWO_SIDED|95.0|62.94|80.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||80.92|62.94|
91672485|NCT02723773|183240104|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.73|||||TWO_SIDED|95.0|84.89|90.12|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control 50 YOA Group.||90.12|84.89|
91672486|NCT02723773|183240104|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.74|||||TWO_SIDED|95.0|86.25|95.37|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||95.37|86.25|
91715792|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Day 13/Early Termination analyses||0.07|-0.56|
91715793|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.81|-0.19|||ANCOVA|||Day 13/Early Termination analyses||-0.19|-0.81|
91715794|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.1|0.51|||ANCOVA|||Day 13/Early Termination analyses||0.51|-0.10|
91638550|NCT01018680|183168425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||Using a 1:1 ratio of allocation to treatment, a 2-tailed 0.05 level of significance and 80% power, 253 participants per arm had been estimated to be adequate to assess an effect size of 0.25, based on a 2-sample Student's t-test. This derived estimate was increased slightly to 261 participants per arm to account for extremely early discontinuation that would have led to exclusion from the efficacy analysis in a small number of participants (approximately 3%).||||<0.001
91638551|NCT01018680|183168426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0||||First gated secondary outcome measure. Gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 secondary outcomes with sequential comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638552|NCT01018680|183168427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.84|||<|0.001||95.0||||WOMAC Physical Disability Score p-value. Second gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 2 secondary outcomes with sequential treatment comparisons until outcome failed significance (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638553|NCT01018680|183168427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.001||95.0||||This is the p-value for the WOMAC Pain Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638554|NCT01018680|183168427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.004||95.0||||This is the p-value for WOMAC Stiffness Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.004
91638555|NCT01018680|183168428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001||95.0||||This is the p-value for Night Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638556|NCT01018680|183168428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||<|0.001||95.0||||This is the p-value for Worst Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638557|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001||95.0||||This is the p-value for BPI-S for Worst Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638558|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0||||This is the p-value for BPI-S for Least Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638559|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-S for Average Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638560|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001||95.0||||This is the p-value for BPI-S for Pain Right Now. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638561|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001||95.0||||This is the p-value for BPI-I for General Activity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638562|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.001||95.0||||This is the p-value for BPI-I for Mood. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638563|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-I for Walking Ability. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638564|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.001||95.0||||This is the p-value for BPI-I for Normal Work. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91672487|NCT02723773|183240104|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.57|||||TWO_SIDED|95.0|86.66|96.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||96.24|86.66|
91672488|NCT02723773|183240104|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.45|||||TWO_SIDED|95.0|82.98|89.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||89.33|82.98|
91792914|NCT04594369|183463305|SUPERIORITY||Difference in LS Mean|0.038|STANDARD_ERROR_OF_MEAN|0.0136|=|0.0054|TWO_SIDED|95.0|0.011|0.065||Adjusted p-value = 0.0364. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.|Linear repeated measures model|||Analysis on linear repeated measure model=treatment visit, sputum sample for Pseudomonas aeruginosa at start, PE \[\<3 or ≥3\] last 12 months, stratification region, age group (fixed effect) \& baseline (covariate). Robust sandwich covariance estimator used.||0.065|0.011|=0.0054
91638565|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001||95.0||||This is the p-value for BPI-I for Relations with Others. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638566|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001||95.0||||This is the p-value for BPI-I for Sleep. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638567|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||<|0.001||95.0||||This is the p-value for BPI-I for Enjoyment of Life. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638568|NCT01018680|183168429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0||||This is the p-value for BPI-I for Mean Interference Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638569|NCT01018680|183168430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638570|NCT01018680|183168431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
91638571|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.449||95.0||||This is the p-value for the BPOMS Total Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.449
91638572|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.265||95.0||||This is the p-value for the BPOMS Tension-Anxiety Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.265
91638573|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.18||95.0||||This is the p-value for the BPOMS Depression-Dejection Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.180
91638574|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.041||95.0||||This is the p-value for the BPOMS Anger-Hostility Score. 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.041
91638575|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.356||95.0||||This is the p-value for the BPOMS Vigor-Activity Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.356
91638576|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.862||95.0||||This is the p-value for the BPOMS Fatigue-Inertia Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.862
91638577|NCT01018680|183168432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.883||95.0||||This is the p-value for the BPOMS Confusion-Bewilderment Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.883
91715795|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||Day 13/Early Termination analyses||0.26|-0.35|
91715796|NCT00549549|183322356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.6|0.01|||ANCOVA|||Day 13/Early Termination analyses||0.01|-0.60|
91526409|NCT04078035|182927989|SUPERIORITY||Slope|0.0021|STANDARD_ERROR_OF_MEAN|0.00027|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 66.4, p \< .001.||Results-interaction between time2 and condition||||<.001
91638578|NCT01018680|183168433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.083||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.083
91638579|NCT01018680|183168434|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
91638580|NCT01018680|183168435|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
91638581|NCT01018680|183168435|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
91715797|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.28|0.14|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.14|-0.28|
91715798|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Day 1, 2 hours postdose||0.03|-0.39|
91715799|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.11|0.52|||ANCOVA|||Day 1, 2 hours postdose||0.52|0.11|
91715800|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.04|0.45|||ANCOVA|||Day 1, 2 hours postdose||0.45|0.04|
91715801|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Day 1, 2 hours postdose||0.34|-0.08|
91485522|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-4.3||||0.105|TWO_SIDED|95.0|-9.6|0.9|||Chan and Zhang method|||Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.9|-9.6|0.105
91485523|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-3.5||||0.09|TWO_SIDED|95.0|-7.6|0.6|||Chan and Zhang method|||Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.6|-7.6|0.090
91638582|NCT01018680|183168436|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
91638583|NCT01018680|183168436|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
91638584|NCT01018680|183168437|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.012
91638585|NCT01018680|183168438|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||This is the p-value for PCS Weight Gain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.724
91638586|NCT01018680|183168438|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||This is the p-value for PCS Weight Loss. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.106
91638587|NCT01018680|183168439|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.031
91638588|NCT01018680|183168440|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||This is the p-value for Diastolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.063
91638589|NCT01018680|183168440|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||This is the p-value for Systolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.018
91638590|NCT01018680|183168441|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.249
91638591|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||This is the p-value for outpatient group visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.241
91638592|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||This is the p-value for outpatient individual visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.087
91638593|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||This is the p-value for emergency room visits for non-psychiatric illness. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.414
91638594|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||This is the p-value for outpatient visits to other physicians. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.332
91638595|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.183||95.0||||This is the p-value for the average number of hours worked for pay per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.183
91638596|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||This is the p-value for how long the participant has had this job. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.666
91638597|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||This is the p-value for the average number of hours of volunteer work per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.890
91638598|NCT01018680|183168442|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||This is the p-value for psychiatric visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.413
91638599|NCT05056311|183168460|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
91638600|NCT05056311|183168461|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
91638601|NCT05056311|183168462|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
91638602|NCT05056311|183168464|SUPERIORITY|||||||0.0001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.0001
91638603|NCT05056311|183168465|SUPERIORITY|||||||0.6374||||||The a priori threshold for statistical significance was \<0.05.|McNemar|||||||0.6374
91638604|NCT01714726|183168472|SUPERIORITY||Risk Difference (RD)|22.5|||=|0.01|TWO_SIDED|90.0|8.3|36.8|||Regression, Logistic|||||36.8|8.3|=0.01
91638605|NCT00665366|183168504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.058|TWO_SIDED|95.0|-4.14|0.07|||ANCOVA|||||0.07|-4.14|0.058
91638606|NCT00665366|183168505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.669|TWO_SIDED|95.0|-0.16|0.25|||ANOVA/ANCOVA||Week 3|||0.25|-0.16|0.669
91638607|NCT00665366|183168505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.436|TWO_SIDED|95.0|-0.36|0.16|||ANOVA/ANCOVA||Week 6|||0.16|-0.36|0.436
91792915|NCT04594369|183463306|SUPERIORITY||Rate ratio|0.742|||=|0.1277|TWO_SIDED|95.0|0.505|1.089||Adjusted p-value = 0.3841. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.|Negative binomial regression|||Analysis based on a negative binomial model including treatment, sputum sample for Pseudomonas aeruginosa at screening, PE \[\<3 or ≥3\] in previous 12 months, stratification region and age group. Robust sandwich covariance estimator used.||1.089|0.505|=0.1277
91526410|NCT04078035|182927990|SUPERIORITY||Slope|0.0013|STANDARD_ERROR_OF_MEAN|0.0002|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||Results-interaction between time\^2 and condition||||<.001
91638608|NCT00665366|183168505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.053|TWO_SIDED|95.0|-0.56|0.0|||ANOVA/ANCOVA||Week 9|||0.00|-0.56|0.053
91638609|NCT00665366|183168505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.044|TWO_SIDED|95.0|-0.59|-0.01|||ANOVA/ANCOVA||Week 12|||-0.01|-0.59|0.044
91638610|NCT00665366|183168506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.22|0.06|||ANOVA/ANCOVA model||Week 3|||0.06|-0.22|0.240
91638611|NCT00665366|183168506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.843|TWO_SIDED|95.0|-0.15|0.19|||ANOVA/ANCOVA model||Week 6|||0.19|-0.15|0.843
91638612|NCT00665366|183168506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.117|TWO_SIDED|95.0|-0.04|0.35|||ANOVA/ANCOVA model||Week 9|||0.35|-0.04|0.117
91638613|NCT00665366|183168506|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.17||||0.109|TWO_SIDED|95.0|-0.04|0.38|||ANOVA/ANCOVA model|Week 12||||0.38|-0.04|0.109
91638614|NCT00665366|183168507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.567|TWO_SIDED|95.0|-0.37|0.2|||ANOVA/ANCOVA model|Week 12||||0.20|-0.37|0.567
91638615|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.566|TWO_SIDED|95.0|-1.66|3.03|||ANCOVA||Total score: Week 3|||3.03|-1.66|0.566
91638616|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.221||95.0|-1.0|4.32|||ANCOVA||Total score: Week 6|||4.32|-1.00|0.221
91638617|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.315|TWO_SIDED|95.0|-1.4|4.35|||ANCOVA||Total score: Week 9|||4.35|-1.40|0.315
91638618|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.212|TWO_SIDED|95.0|-1.08|4.84|||ANCOVA||Total score: Week 12|||4.84|-1.08|0.212
91672489|NCT02723773|183240104|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.33|||||TWO_SIDED|95.0|79.91|87.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||87.93|79.91|
91672490|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.68|||||TWO_SIDED|95.0|93.07|99.53|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 1.||99.53|93.07|
91715802|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.37|0.08|||ANCOVA|||Day 1, 4 hours postdose||0.08|-0.37|
91715803|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.48|-0.03|||ANCOVA|||Day 1, 4 hours postdose||-0.03|-0.48|
91638619|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.49|0.48|||ANCOVA||Autonomy score: Week 3|||0.48|-0.49|0.991
91638620|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.201|TWO_SIDED|95.0|-0.18|0.85|||ANCOVA||Autonomy score: Week 6|||0.85|-0.18|0.201
91638621|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.198|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||Autonomy score: Week 9|||0.93|-0.19|0.198
91638622|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.178|TWO_SIDED|95.0|-0.18|0.96|||ANCOVA||Autonomy score: Week 12|||0.96|-0.18|0.178
91638623|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.311|TWO_SIDED|95.0|-1.01|0.32|||ANCOVA||Occupational functioning score: Week 3|||0.32|-1.01|0.311
91638624|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.671|TWO_SIDED|95.0|-0.94|0.61|||ANCOVA||Occupational functioning score: Week 6|||0.61|-0.94|0.671
91638625|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.968|TWO_SIDED|95.0|-0.83|0.79|||ANCOVA||Occupational functioning score: Week 9|||0.79|-0.83|0.968
91638626|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.546|TWO_SIDED|95.0|-0.56|1.07|||ANCOVA||Occupational functioning score: Week 12|||1.07|-0.56|0.546
91638627|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.284|TWO_SIDED|95.0|-0.28|0.96|||ANCOVA||Cognitive functioning score: Week 3|||0.96|-0.28|0.284
91638628|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.063|TWO_SIDED|95.0|-0.04|1.35|||ANCOVA||Cognitive functioning score: Week 6|||1.35|-0.04|0.063
91638629|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.09|TWO_SIDED|95.0|-0.1|1.34|||ANCOVA||Cognitive functioning score: Week 9|||1.34|-0.10|0.090
91638630|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.072|TWO_SIDED|95.0|-0.06|1.42|||ANCOVA||Cognitive functioning score: Week 12|||1.42|-0.06|0.072
91638631|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.499|TWO_SIDED|95.0|-0.45|0.93|||ANCOVA||Interpersonal relationships score: Week 3|||0.93|-0.45|0.499
91638632|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.457|TWO_SIDED|95.0|-0.48|1.06|||ANCOVA||Interpersonal relationships score: Week 6|||1.06|-0.48|0.457
91638633|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.525||95.0|-0.56|1.1|||ANCOVA||Interpersonal relationships score: Week 9|||1.10|-0.56|0.525
91715804|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.14|0.58|||ANCOVA|||Day 1, 4 hours postdose||0.58|0.14|
91715805|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.0|0.44|||ANCOVA|||Day 1, 4 hours postdose||0.44|0.00|
91672491|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|96.76|||||TWO_SIDED|95.0|80.57|99.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 1.||99.92|80.57|
91672492|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|79.32|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 1.||100.00|79.32|
91672493|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.97|||||TWO_SIDED|95.0|92.46|99.76|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 1.||99.76|92.46|
91672494|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.57|||||TWO_SIDED|95.0|90.96|99.71|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 1.||99.71|90.96|
91672495|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.69|||||TWO_SIDED|95.0|86.15|96.57|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 2.||96.57|86.15|
91672496|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.66|||||TWO_SIDED|95.0|70.78|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 2.||99.15|70.78|
91672497|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|95.49|||||TWO_SIDED|95.0|72.11|99.89|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 2.||99.89|72.11|
91715806|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.34|||ANCOVA|||Day 1, 4 hours postdose||0.34|-0.11|
91715807|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Day 1, 8 hours postdose||0.17|-0.32|
91715808|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.56|-0.06|||ANCOVA|||Day 1, 8 hours postdose||-0.06|-0.56|
91715809|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.18|0.67|||ANCOVA|||Day 1, 8 hours postdose||0.67|0.18|
91715810|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.11|0.59|||ANCOVA|||Day 1, 8 hours postdose||0.59|0.11|
91715811|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.13|0.36|||ANCOVA|||Day 1, 8 hours postdose||0.36|-0.13|
91792916|NCT04594369|183463306|SUPERIORITY||Rate ratio|0.74|||=|0.1025|TWO_SIDED|95.0|0.515|1.062||Adjusted p-value = 0.2050. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.|Negative binomial regression|||Analysis based on a negative binomial model including treatment, sputum sample for Pseudomonas aeruginosa at screening, PE \[\<3 or ≥3\] in previous 12 months, stratification region and age group. Robust sandwich covariance estimator used.||1.062|0.515|=0.1025
91715812|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Day 1, 12 hours postdose||0.10|-0.42|
91526411|NCT04078035|182927991|SUPERIORITY||Slope|0.0037|STANDARD_ERROR_OF_MEAN|0.0013||0.005|TWO_SIDED||||||Mixed Models Analysis|||Results below present the condition (stress/control) by time interactions.||||0.005
91792917|NCT04594369|183463307|SUPERIORITY||LS mean difference|2.031|STANDARD_ERROR_OF_MEAN|1.0775|=|0.0594|TWO_SIDED|95.0|-0.081|4.143||Adjusted p-value = 0.3841. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.|linear repeated measures model|||Analysis based on a linear repeated measures model with treatment group, visit, sputum sample for Pseudomonas aeruginosa at screening, pulmonary exacerbations \[\<3 or ≥3\] in previous 12 months, stratification region fixed effect, baseline as covariate.||4.143|-0.081|=0.0594
91715813|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.63|-0.11|||ANCOVA|||Day 1, 12 hours postdose||-0.11|-0.63|
91715814|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.19|0.7|||ANCOVA|||Day 1, 12 hours postdose||0.70|0.19|
91715815|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.03|0.55|||ANCOVA|||Day 1, 12 hours postdose||0.55|0.03|
91715816|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.18|0.34|||ANCOVA|||Day 1, 12 hours postdose||0.34|-0.18|
91715817|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.46|0.07|||ANCOVA|||Day 2, 0 hours postdose||0.07|-0.46|
91715818|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|-0.04|||ANCOVA|||Day 2, 0 hours postdose||-0.04|-0.57|
91715819|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Day 2, 0 hours postdose||0.68|0.16|
91485524|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|1.8||||0.59|TWO_SIDED|95.0|-4.2|7.8|||Chan and Zhang method|||Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||7.8|-4.2|0.590
91715820|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.04|0.49|||ANCOVA|||Day 2, 0 hours postdose||0.49|-0.04|
91715821|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.15|0.38|||ANCOVA|||Day 2, 0 hours postdose||0.38|-0.15|
91715822|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.14|||ANCOVA|||Day 2, 8 hours postdose||0.14|-0.40|
91526412|NCT04078035|182927992|SUPERIORITY||Slope|-0.0071|STANDARD_ERROR_OF_MEAN|0.074||0.92|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.92
91715823|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.59|-0.05|||ANCOVA|||Day 2, 8 hours postdose||-0.05|-0.59|
91715824|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Day 2, 8 hours postdose||0.74|0.20|
91715825|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.08|0.61|||ANCOVA|||Day 2, 8 hours postdose||0.61|0.08|
91715826|NCT00549549|183322357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.42|||ANCOVA|||Day 2, 8 hours postdose||0.42|-0.11|
91485525|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.044|TWO_SIDED|95.0|-7.5|-0.1|||Chan and Zhang method|||Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.1|-7.5|0.044
91715827|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.09|0.27|||ANCOVA|||8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.27|-0.09|
91715828|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.04|0.4|||ANCOVA|||8 hour postdose analysis||0.40|0.04|
91715829|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||8 hour postdose analysis||-0.14|-0.50|
91715830|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.41|-0.05|||ANCOVA|||8 hour postdose analysis||-0.05|-0.41|
91715831|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.28|0.08|||ANCOVA|||8 hour postdose analysis||0.08|-0.28|
91715832|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||12 hour postdose analysis||0.29|-0.10|
91715833|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.06|0.45|||ANCOVA|||12 hour postdose analysis||0.45|0.06|
91715834|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||12 hour postdose analysis||-0.16|-0.55|
91715835|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||12 hour postdose analysis||-0.07|-0.45|
91715836|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||12 hour postdose analysis||0.09|-0.29|
91715837|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.35|||ANCOVA|||24 hour postdose analysis||0.35|-0.08|
91715838|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.08|0.51|||ANCOVA|||24 hour postdose analysis||0.51|0.08|
91715839|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|||24 hour postdose analysis||-0.18|-0.61|
91638634|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.544|TWO_SIDED|95.0|-0.58|1.09|||ANCOVA||Interpersonal relationships score: Week 12|||1.09|-0.58|0.544
91672498|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.71|||||TWO_SIDED|95.0|85.13|96.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 2.||96.93|85.13|
91638635|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.149|TWO_SIDED|95.0|-0.08|0.52|||ANCOVA||Leisure time score: Week 3|||0.52|-0.08|0.149
91638636|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.264|TWO_SIDED|95.0|-0.15|0.54|||ANCOVA||Leisure time score: Week 6|||0.54|-0.15|0.264
91638637|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA||Leisure time score: Week 9|||0.35|-0.35|0.988
91638638|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.641|TWO_SIDED|95.0|-0.27|0.44|||ANCOVA||Leisure time score: Week 12|||0.44|-0.27|0.641
91638639|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.068|TWO_SIDED|95.0|-0.02|0.61|||ANCOVA||Financial issues score: Week 3|||0.61|-0.02|0.068
91638640|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.019|TWO_SIDED|95.0|0.07|0.74|||ANCOVA||Financial issues score: Week 6|||0.74|0.07|0.019
91638641|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.136|TWO_SIDED|95.0|-0.08|0.6|||ANCOVA||Financial issues score: Week 9|||0.60|-0.08|0.136
91638642|NCT00665366|183168508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.18||95.0|-0.11|0.57|||ANCOVA||Financial issues score: Week 12|||0.57|-0.11|0.18
91638643|NCT00665366|183168509|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.466|TWO_SIDED|95.0|0.81|1.59|||Ration of response||Week 3|||1.59|0.81|0.466
91638644|NCT00665366|183168509|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.54|TWO_SIDED|95.0|0.86|1.32|||Risk ratio||Week 6|||1.32|0.86|0.540
91638645|NCT00665366|183168509|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.06|TWO_SIDED|95.0|0.99|1.38|||Risk ratio||Week 9|||1.38|0.99|0.060
91638646|NCT00665366|183168509|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.289|TWO_SIDED|95.0|0.94|1.23|||Risk ratio|||||1.23|0.94|0.289
91638647|NCT00665366|183168510|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.909|TWO_SIDED|95.0|0.75|1.39|||Risk ratio (RR)||Week 3|||1.39|0.75|0.909
91638648|NCT00665366|183168510|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.573|TWO_SIDED|95.0|0.86|1.3|||RR||Week 6|||1.30|0.86|0.573
91638649|NCT00665366|183168510|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.08|TWO_SIDED|95.0|0.98|1.36|||RR||Week 9|||1.36|0.98|0.080
91638650|NCT00665366|183168510|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.211|TWO_SIDED|95.0|0.95|1.27|||RR||Week 12|||1.27|0.95|0.211
91638651|NCT00665366|183168511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|0.07|1.29|||ANOVA/ANCOVA model||Week 6|||1.29|0.07|
91638652|NCT00665366|183168511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA/ANCOVA model||Week 12|||1.58|0.08|0.031
91638653|NCT00665366|183168511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.104|TWO_SIDED|95.0|-0.13|1.34|||ANOVA/ANCOVA model||Week 12 (LOCF)|||1.34|-0.13|0.104
91638654|NCT00665366|183168512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.21|0.32|||ANCOVA||Week 3|||0.32|-0.21|
91638655|NCT00665366|183168512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.05|0.53|||ANCOVA||Week 6|||0.53|-0.05|
91638656|NCT00665366|183168512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.197|TWO_SIDED|95.0|-0.11|0.54|||ANCOVA||Week 12|||0.54|-0.11|0.197
91638657|NCT00665366|183168512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.111|TWO_SIDED|95.0|-0.07|0.63|||ANCOVA||Week 12 (LOCF)|||0.63|-0.07|0.111
91638658|NCT00665366|183168513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.983|TWO_SIDED|95.0|-0.63|0.64|||ANOVA/ANCOVA model||Week 12 LOCF|||0.64|-0.63|0.983
91638659|NCT00665366|183168514|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.57|3.71|||Risk Ratio|Weight gain||||3.71|0.57|
91638660|NCT00665366|183168515|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.582||95.0|||||ANCOVA|||||||0.582
91638661|NCT03628781|183168516|SUPERIORITY||Odds Ratio (OR)|0.384||||0.535|TWO_SIDED||||||Chi-squared|||||||.535
91638662|NCT03628781|183168517|SUPERIORITY||Slope|0.018|STANDARD_ERROR_OF_MEAN|0.081||0.829|TWO_SIDED||||||ANOVA|||||||.829
91638663|NCT03628781|183168518|SUPERIORITY||Slope|-0.105|STANDARD_ERROR_OF_MEAN|0.093||0.357|TWO_SIDED||||||ANOVA|||||||.357
91638664|NCT03628781|183168519|SUPERIORITY||Slope|-0.035|STANDARD_ERROR_OF_MEAN|0.126||0.782|TWO_SIDED||||||ANOVA|||||||.782
91638665|NCT00994123|183168523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.008|TWO_SIDED|95.0|0.16|0.76|||Log Rank|||||0.76|0.16|0.008
91638666|NCT00994123|183168523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.15||||0.059|TWO_SIDED|95.0|0.97|4.76|||Log Rank|||||4.76|0.97|0.059
91672499|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.01|||||TWO_SIDED|95.0|82.82|96.88|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 2.||96.88|82.82|
91715840|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.47|-0.05|||ANCOVA|||24 hour postdose analysis||-0.05|-0.47|
91715841|NCT00549549|183322358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.32|0.11|||ANCOVA|||24 hour postdose analysis||0.11|-0.32|
91638667|NCT03778021|183168524|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.093||0.017|TWO_SIDED|95.0|0.04|0.41||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05."|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change (intervention minus control) from repeated measures linear mixed model|"The unit of measure is score on a scale. The results show the least squares estimate of change in that score, from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|"In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured)."|0.41|0.04|0.017
91715842|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||||0.0459
91715843|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0017
91638668|NCT03778021|183168525|SUPERIORITY||Mean Difference (Net)|1.41||||0.18|TWO_SIDED|95.0|-0.66|3.49||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05"|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change from baseline to follow-up from model (intervention minus control)|"Results present estimated change in score from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools|3.49|-0.66|0.18
91638669|NCT03778021|183168526|SUPERIORITY||Odds Ratio (OR)|1.29||||0.51|TWO_SIDED|95.0|0.6|2.81||"Repeated measures generalized linear mixed model with binomial distribution (variable was I know I can - yes versus no)."|Mixed Models Analysis|The odds of the odds ratio is reported as the intervention effect.|Odds ratio from estimated least squares from generalized mixed model with binomial distribution specified. Intervention odds of change compared to comparison group odds of change via odds ratio..|"Odds ratio of 8-month follow-up to baseline percent reporting  I know I can was estimated from repeated measures generalized linear mixed model with binomial distribution.~Values included from the 100 and 194 baseline respondents and from the 72 and 141 8-month follow-up respondents of intervention and comparison groups respectively. The person-timepoint is the unit of analysis."||2.81|0.60|0.51
91638670|NCT01928758|183168540|OTHER||Mean Difference (Final Values)|-175.7|||<|0.0001|TWO_SIDED|95.0|-218.3|-133.1||Complete case analysis|Regression, Linear|Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||-133.1|-218.3|<0.0001
91672500|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.36|||||TWO_SIDED|95.0|84.98|96.59|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 3.||96.59|84.98|
91672501|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.2|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 3.||100.00|89.20|
91672502|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.39|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 3.||100.00|89.39|
91672503|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.84|||||TWO_SIDED|95.0|79.81|95.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 3.||95.51|79.81|
91715844|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0001
91715845|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0410
91715846|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.5592
91715847|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0277
91792918|NCT04594369|183463307|SUPERIORITY||LS mean difference|3.766|STANDARD_ERROR_OF_MEAN|1.0642|=|0.0004|TWO_SIDED|95.0|1.68|5.852||Adjusted p-value = 0.2050. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.|linear repeated measures model|||Analysis based on a linear repeated measures model with treatment group, visit, sputum sample for Pseudomonas aeruginosa at screening, pulmonary exacerbations \[\<3 or ≥3\] in previous 12 months, stratification region fixed effect, baseline as covariate.||5.852|1.680|=0.0004
91792919|NCT03875235|183463319|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.021|TWO_SIDED|97.0|0.64|0.99||The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for OS at the second interim analysis was 3%.|95% CI 0.66 to 0.97|0.99|0.64|0.021
91672504|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.74|||||TWO_SIDED|95.0|68.99|93.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 3.||93.35|68.99|
91672505|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.75|||||TWO_SIDED|95.0|80.31|95.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 4.||95.24|80.31|
91672506|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.88|||||TWO_SIDED|95.0|60.62|99.85|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 4.||99.85|60.62|
91672507|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.62|||||TWO_SIDED|95.0|66.1|99.04|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 4.||99.04|66.10|
91672508|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.96|||||TWO_SIDED|95.0|77.96|95.13|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 4.||95.13|77.96|
91672509|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.86|||||TWO_SIDED|95.0|73.3|95.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 4.||95.33|73.30|
91715848|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0018
91715849|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||<.0001
91715850|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0394
91485526|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-1.4||||0.574|TWO_SIDED|95.0|-6.2|3.4|||Chan and Zhang method|||Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.4|-6.2|0.574
91715851|NCT00549549|183322359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4603|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.4603
91715852|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5528
91715853|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1779
91485527|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-1.2||||0.648|TWO_SIDED|95.0|-6.3|3.9|||Chan and Zhang method|||Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.9|-6.3|0.648
91672510|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.87|||||TWO_SIDED|95.0|68.31|92.63|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 6.||92.63|68.31|
91715854|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1754|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1754
91715855|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.3384
91485528|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-6.2||||0.057|TWO_SIDED|95.0|-12.5|0.2|||Chan and Zhang method|||Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.2|-12.5|0.057
91485529|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.03|TWO_SIDED|95.0|-7.3|-0.3|||Chan and Zhang method|||Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.3|-7.3|0.030
91672511|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|46.83|98.61|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 6.||98.61|46.83|
91672512|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.31|||||TWO_SIDED|95.0|48.79|99.82|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 6.||99.82|48.79|
91672513|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.98|||||TWO_SIDED|95.0|63.64|93.05|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 6.||93.05|63.64|
91672514|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.0|||||TWO_SIDED|95.0|54.3|92.5|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 6.||92.50|54.30|
91672515|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.61|||||TWO_SIDED|95.0|67.76|92.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 7.||92.51|67.76|
91715856|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5005
91715857|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0845
91715858|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0213|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0213
91715859|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1231|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1231
91485530|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-2.5||||0.233|TWO_SIDED|95.0|-6.6|1.6|||Chan and Zhang method|||Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.6|-6.6|0.233
91715860|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6636|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6636
91715861|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5378|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5378
91485531|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-1.8||||0.152|TWO_SIDED|95.0|-4.5|0.7|||Chan and Zhang method|||Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.7|-4.5|0.152
91485532|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.926|TWO_SIDED|95.0|-5.1|5.8|||Chan and Zhang method|||Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||5.8|-5.1|0.926
91485533|NCT02124161|182844164|SUPERIORITY_OR_OTHER||Percentage Difference|-3.9||||0.143|TWO_SIDED|95.0|-9.1|1.3|||Chan and Zhang method|||Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.3|-9.1|0.143
91638671|NCT01928758|183168541|OTHER||Mean Difference (Final Values)|0.69||||0.16|TWO_SIDED|95.0|-0.28|1.65||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.65|-0.28|0.16
91638672|NCT01928758|183168542|OTHER||Mean Difference (Final Values)|0.38||||0.67|TWO_SIDED|95.0|-1.4|2.16||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||2.16|-1.40|0.67
91638673|NCT01928758|183168543|OTHER||Mean Difference (Final Values)|-0.31||||0.65|TWO_SIDED|95.0|-1.68|1.05||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.05|-1.68|0.65
91638674|NCT04051320|183168568|SUPERIORITY||F statistic|2.164||||0.16|TWO_SIDED||||||repeated measures ANOVA|||||||0.160
91638675|NCT04051320|183168569|SUPERIORITY||F statistic|1.74||||0.1922|TWO_SIDED||||||ANOVA|||||||0.1922
91638676|NCT04051320|183168570|SUPERIORITY||F statistic|0.837||||0.368|TWO_SIDED||||||ANOVA|||||||0.368
91638677|NCT04051320|183168571|SUPERIORITY||F statistic|0.23||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
91638678|NCT04051320|183168572|SUPERIORITY||F statistic|16.541||||0.000723|TWO_SIDED||||||ANOVA|||||||0.000723
91638679|NCT04051320|183168573|SUPERIORITY||F statistic|0.072||||0.791|TWO_SIDED||||||ANOVA|||||||0.791
91638680|NCT04051320|183168574|SUPERIORITY||F statistic|4.952||||0.0372|TWO_SIDED||||||ANOVA|||||||0.0372
91638681|NCT04051320|183168575|SUPERIORITY||F statistic|3.258||||0.0861|TWO_SIDED||||||ANOVA|||||||0.0861
91638682|NCT04051320|183168576|SUPERIORITY||F statistic|2.37||||0.139|TWO_SIDED||||||ANOVA|||||||0.139
91638683|NCT04051320|183168577|SUPERIORITY||F statistic|1.484||||0.237|TWO_SIDED||||||ANOVA|||||||0.237
91672516|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.33|||||TWO_SIDED|95.0|56.67|99.84|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 7.||99.84|56.67|
91715862|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0818
91485534|NCT02124161|182844167|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.0|||Chan and Zhang method|||Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||11.0|-0.9|0.094
91638684|NCT04051320|183168578|SUPERIORITY||F statistic|0.013||||0.91|TWO_SIDED||||||ANOVA|||||||0.910
91638685|NCT04051320|183168579|SUPERIORITY||F statistic|4.609||||0.0449|TWO_SIDED||||||ANOVA|||||||0.0449
91638686|NCT04051320|183168580|SUPERIORITY|||||||0.322|||||||Pearson's Correlation Coefficient|||||||0.322
91638687|NCT04051320|183168580|SUPERIORITY|||||||0.772|||||||Pearson's Correlation Coefficient|||||||0.772
91638688|NCT04051320|183168581|SUPERIORITY||Pearson's r|-0.568314||||0.068|TWO_SIDED||||||Pearson correlation|||||||0.068
91638689|NCT04051320|183168581|SUPERIORITY||Pearson's r|-0.082904||||0.8759289|TWO_SIDED||||||Pearson correlation|||||||0.8759289
91638690|NCT04051320|183168582|SUPERIORITY||Pearson's r|-0.1275539||||0.70859639|TWO_SIDED||||||Pearson correlation|||||||0.70859639
91638691|NCT04051320|183168582|SUPERIORITY||Pearson's r|0.49225646||||0.2617744|TWO_SIDED||||||Pearson correlation|||||||0.2617744
91638692|NCT04051320|183168583|SUPERIORITY|||||||0.568|||||||Pearson's Correlation Coefficient|||||||0.568
91638693|NCT04051320|183168583|SUPERIORITY|||||||0.944|||||||Pearson's Correlation Coefficient|||||||0.944
91638694|NCT04051320|183168584|SUPERIORITY|||||||0.103|||||||Pearson's Correlation Coefficient|||||||0.103
91638695|NCT01294319|183168597|SUPERIORITY|||||||0.4872|||||||Fisher Exact|||||||0.4872
91638696|NCT01294319|183168598|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||||||0.2786
91638697|NCT00877929|183168697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.2|-7.9|0.0001
91638698|NCT00877929|183168698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1||||0.0001||95.0|-8.9|-5.4|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-5.4|-8.9|0.0001
91638699|NCT00877929|183168699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0001||95.0|-8.3|-4.9|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.9|-8.3|0.0001
91638700|NCT00877929|183168700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.3|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.3|-7.9|0.0001
91485535|NCT02124161|182844167|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-3.8||||0.232|TWO_SIDED|95.0|-9.9|2.4|||Chan and Zhang method|||Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.4|-9.9|0.232
91485536|NCT02124161|182844167|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.0||||0.734|TWO_SIDED|95.0|-6.6|4.5|||Chan and Zhang method|||Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.5|-6.6|0.734
91638701|NCT00877929|183168701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0001||95.0|-6.6|-3.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-3.2|-6.6|0.0001
91638702|NCT01140646|183168738|SUPERIORITY_OR_OTHER|||||||0.0903||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash score is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.0903
91485537|NCT02124161|182844167|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.5||||0.627|TWO_SIDED|95.0|-7.2|4.3|||Chan and Zhang method|||Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.3|-7.2|0.627
91485538|NCT02439879|182844171|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t test|||All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM||||< 0.05
91485539|NCT03789214|182844207|OTHER|One-way ANOVA||||||0.95|||||||ANOVA|||||||.950
91638703|NCT01140646|183168738|SUPERIORITY_OR_OTHER|||||||0.1553||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash frequency is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.1553
91638704|NCT03006276|183168743|SUPERIORITY||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.36|2.94|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.94|1.36|<0.001
91638705|NCT03006276|183168743|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.001|TWO_SIDED|95.0|1.34|2.89|||Fisher Exact|||||2.89|1.34|<0.001
91638706|NCT03006276|183168744|SUPERIORITY||Odds Ratio (OR)|1.68||||0.007|TWO_SIDED|95.0|1.17|2.43|||Fisher Exact|||last observation carried forward (LOCF)||2.43|1.17|0.007
91638707|NCT03006276|183168744|SUPERIORITY||Odds Ratio (OR)|1.69||||0.007|TWO_SIDED|95.0|1.16|2.44|||Fisher Exact|||observed cases (OC)||2.44|1.16|0.007
91638708|NCT00689728|183168770|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Fisher Exact|||||||0.178
91638709|NCT00689728|183168770|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
91638710|NCT00689728|183168772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.873||||0.062||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.062
91638711|NCT00689728|183168772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.427||||0.052||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.052
91638712|NCT00689728|183168772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.655||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.655
91638713|NCT00689728|183168772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.264||||0.173||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.173
91638714|NCT00689728|183168773|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Fisher Exact|||||||0.281
91638715|NCT00689728|183168773|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||||||0.218
91638716|NCT00689728|183168774|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.500
91638717|NCT00689728|183168774|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||Fisher Exact|||||||0.444
91638718|NCT00689728|183168775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.337||95.0|||||ANCOVA|||||||0.337
91638719|NCT00689728|183168775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.038||95.0|||||ANCOVA|||||||0.038
91638720|NCT00689728|183168776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.403||95.0|||||ANCOVA|||||||0.403
91638721|NCT00689728|183168776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.006||95.0|||||ANCOVA|||||||0.006
91638722|NCT00689728|183168777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.168||95.0|||||ANCOVA|||||||0.168
91638723|NCT00689728|183168777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.075||95.0|||||ANCOVA|||||||0.075
91638724|NCT00689728|183168778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.157||95.0|||||ANCOVA|||||||0.157
91638725|NCT00689728|183168778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6||||0.025||95.0|||||ANCOVA|||||||0.025
91638726|NCT00689728|183168779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.11||95.0|||||ANCOVA|||||||0.110
91638727|NCT00689728|183168779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1||||0.147||95.0|||||ANCOVA|||||||0.147
91638728|NCT00689728|183168780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172||||0.969||95.0|||||ANCOVA|||||||0.969
91638729|NCT00689728|183168780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.452||95.0|||||ANCOVA|||||||0.452
91638730|NCT00689728|183168781|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||ANCOVA|||||||0.554
91638731|NCT00689728|183168781|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANCOVA|||||||0.920
91638732|NCT00689728|183168782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.912||||0.1||95.0|||||ANCOVA|||||||0.100
91638733|NCT00689728|183168782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322||||0.005||95.0|||||ANCOVA|||||||0.005
91485540|NCT03789214|182844208|OTHER|One-way ANOVA||||||0.048|||||||ANOVA|||||||.048
91715863|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0317
91485541|NCT03789214|182844209|OTHER|One-way ANOVA||||||0.691|||||||ANOVA|||||||.691
91485542|NCT03789214|182844210|OTHER|One-way ANOVA||||||0.62|||||||ANOVA|||||||.620
91485543|NCT03789214|182844211|OTHER|One-way ANOVA||||||0.067|||||||ANOVA|||||||.067
91638734|NCT00689728|183168783|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||p-value represents comparison of LY2127399-30 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.022
91638735|NCT00689728|183168783|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value represents comparison of LY2127399-80 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.016
91638736|NCT00689728|183168784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.818||95.0|||||ANCOVA|||||||0.818
91638737|NCT00689728|183168784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7||||0.066||95.0|||||ANCOVA|||||||0.066
91638738|NCT00689728|183168785|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||||||0.010
91638739|NCT00689728|183168785|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|||||||0.056
91638740|NCT00689728|183168786|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
91638741|NCT00689728|183168786|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
91638742|NCT00689728|183168787|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.146
91638743|NCT00689728|183168787|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.125
91638744|NCT00689728|183168787|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||<0.001
91638745|NCT00689728|183168787|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||0.005
91638746|NCT00689728|183168787|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.115
91638747|NCT00689728|183168787|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.019
91638748|NCT00842829|183168790|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper limit of the 90% CI was \<8%.|Mean Difference (Net)|-6.3|||||ONE_SIDED|95.0||1.4|||||The upper bound of the 2-sided 90% confidence interval is equivalent to the upper bound of the 1-sided 95% confidence interval.|Treatment comparison difference (100 mcg - 200 mcg)||1.4||
91638749|NCT02155725|183168814|SUPERIORITY||Odds Ratio (OR)|0.9889||||0.9563|TWO_SIDED|95.0|0.6633|1.4744|||Regression, Logistic|||||1.4744|0.6633|0.9563
91638750|NCT02155725|183168815|SUPERIORITY||Odds Ratio (OR)|1.0064||||0.9786|TWO_SIDED|95.0|0.6321|1.6022|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as administration of 2 units of RBCs.||1.6022|0.6321|0.9786
91638751|NCT02155725|183168816|SUPERIORITY||Odds Ratio (OR)|1.0169||||0.9474|TWO_SIDED|95.0|0.6177|1.6741|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as a loss of at least 4 g/dL of Hb.||1.6741|0.6177|0.9474
91638752|NCT02612194|183168857|OTHER|Estimation only.|Overall Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.369|||||Confidence interval estimated using the Clopper Pearson method.|||0.369|0.000|
91638753|NCT02612194|183168858|OTHER|Estimation only|Median|3.1|||||TWO_SIDED|95.0|0.2|6.1|||||The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||6.1|0.2|
91638754|NCT02612194|183168859|OTHER|Estimation only|Median|1.5|||||TWO_SIDED|95.0|0.2|1.8|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||1.8|0.2|
91638755|NCT02539160|183168860|SUPERIORITY||Median Difference (Net)|6.4||||0.105|TWO_SIDED|95.0|-1.1|14.3|||t-test, 2 sided|||||14.3|-1.1|0.105
91638756|NCT02539160|183168860|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.112|TWO_SIDED|95.0|-1.5|13.7|||t-test, 2 sided|||||13.7|-1.5|0.112
91638757|NCT01728454|183168891|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.0360
91638758|NCT01728454|183168891|SUPERIORITY|||||||0.1087|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1087
91638759|NCT01728454|183168891|SUPERIORITY|||||||0.2263|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.2263
91638760|NCT01728454|183168891|SUPERIORITY|||||||0.5375|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5375
91638761|NCT01728454|183168892|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1017
91638762|NCT01728454|183168892|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1927
91638763|NCT01728454|183168892|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1017
91638764|NCT01728454|183168892|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1927
91638765|NCT01728454|183168893|SUPERIORITY|||||||0.7508|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.7508
91638766|NCT01728454|183168893|SUPERIORITY|||||||0.5507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.5507
91638767|NCT01728454|183168893|SUPERIORITY|||||||0.3993|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.3993
91638768|NCT01728454|183168893|SUPERIORITY|||||||0.5821|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5821
91638769|NCT01728454|183168894|SUPERIORITY|||||||0.7507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.7507
91638770|NCT01728454|183168894|SUPERIORITY|||||||0.8919|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.8919
91638771|NCT01728454|183168895|SUPERIORITY|||||||0.478|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.4780
91638772|NCT01728454|183168895|SUPERIORITY|||||||0.2354|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2354
91672517|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 7.||98.31|32.04|
91672518|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.43|||||TWO_SIDED|95.0|59.54|91.58|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 7.||91.58|59.54|
91672519|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|78.79|||||TWO_SIDED|95.0|51.24|92.08|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 7.||92.08|51.24|
91672520|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.76|||||TWO_SIDED|95.0|65.98|92.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 8.||92.14|65.98|
91672521|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 8.||98.52|42.67|
91715864|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1592
91715865|NCT00549549|183322362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7956|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.7956
91715866|NCT00549549|183322363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.17|0.31|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.31|-0.17|
91715867|NCT00549549|183322363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.02|0.46|||ANCOVA|||||0.46|-0.02|
91715868|NCT00549549|183322363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||||-0.02|-0.50|
91485544|NCT00406354|182844233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-1.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.5|-5.0|<.001
91715869|NCT00549549|183322363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.43|0.05|||ANCOVA|||||0.05|-0.43|
91715870|NCT00549549|183322363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||||0.19|-0.28|
91485545|NCT00406354|182844234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-3.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-3.8|-11.0|<.001
91715871|NCT00549549|183322364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.3173
91715872|NCT00549549|183322365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4724|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.4724
91715873|NCT00549549|183322365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
91715874|NCT00549549|183322365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
91715875|NCT00808067|183322417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Regression, Cox|||||0.93|0.64|0.0055
91715876|NCT00808067|183322424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5119|TWO_SIDED|95.0|0.84|1.42|||Regression, Cox|||||1.42|0.84|0.5119
91715877|NCT00808067|183322425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.2371|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox|||||1.29|0.94|0.2371
91792920|NCT03875235|183463322|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.001|TWO_SIDED|95.19|0.63|0.89||The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for PFS at the second interim analysis was 4.81%.|95% CI 0.63 to 0.89|0.89|0.63|0.001
91485546|NCT00406354|182844235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.8|-5.3|<.001
91672522|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 8.||98.31|32.04|
91672523|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|81.4|||||TWO_SIDED|95.0|59.97|92.45|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 8.||92.45|59.97|
91672524|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.65|||||TWO_SIDED|95.0|52.91|93.4|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 8.||93.40|52.91|
91672525|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.68|||||TWO_SIDED|95.0|52.89|86.16|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 9.||86.16|52.89|
91672526|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|66.67|||||TWO_SIDED|95.0|3.52|90.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 9.||90.52|3.52|
91672527|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.73|||||TWO_SIDED|95.0|-3.24|95.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 9.||95.11|-3.24|
91672528|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|76.19|||||TWO_SIDED|95.0|51.78|89.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 9.||89.35|51.78|
91715878|NCT00808067|183322426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5052|TWO_SIDED|95.0|0.89|1.27|||Regression, Cox|||||1.27|0.89|0.5052
91715879|NCT00808067|183322427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.2241||95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.2241
91715880|NCT01107925|183322435|NON_INFERIORITY_OR_EQUIVALENCE|Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.|Estimate of the difference|-10.1||||0.526|TWO_SIDED|95.0|-23.4|0.2|||bootstrap (to determine 95% CI)||Estimate of the difference = \[median (low body weight) - Q3 (higher body weight)\]|||0.20|-23.40|0.526
91715881|NCT03574974|183322482|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
91715882|NCT00830219|183322499|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.53||||||90.0|99.16|108.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.09|99.16|
91792921|NCT03875235|183463325|SUPERIORITY||Odds Ratio (OR)|1.6||||0.011|TWO_SIDED|95.0|1.11|2.31|||Cochran-Mantel-Haenszel||OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.|||2.31|1.11|0.011
91526413|NCT04078035|182927993|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|0.41||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
91638773|NCT01728454|183168896|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
91638774|NCT01728454|183168896|SUPERIORITY|||||||0.1636|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1636
91638775|NCT01728454|183168897|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
91638776|NCT01728454|183168897|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0733
91672529|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|75.86|||||TWO_SIDED|95.0|43.69|91.07|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 9.||91.07|43.69|
91672530|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|71.7|||||TWO_SIDED|95.0|49.03|85.18|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 10.||85.18|49.03|
91672531|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.89|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 10.||100.00|77.89|
91672532|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.0|||||TWO_SIDED|95.0|29.71|99.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 10.||99.77|29.71|
91672533|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|60.53|||||TWO_SIDED|95.0|26.55|79.83|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 10.||79.83|26.55|
91672534|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|48.15|||||TWO_SIDED|95.0|-2.41|74.87|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 10.||74.87|-2.41|
91638777|NCT01728454|183168898|SUPERIORITY|||||||0.1253|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1253
91638778|NCT01728454|183168898|SUPERIORITY|||||||0.3442|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.3442
91638779|NCT01728454|183168899|SUPERIORITY|||||||0.0303|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0303
91638780|NCT01728454|183168899|SUPERIORITY|||||||0.2864|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2864
91672535|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.0|||||TWO_SIDED|95.0|63.03|92.22|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 11.||92.22|63.03|
91672536|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 11.||98.52|42.67|
91638781|NCT01728454|183168900|SUPERIORITY|||||||0.4365|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.4365
91638782|NCT01728454|183168900|SUPERIORITY|||||||0.1302|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.1302
91638783|NCT01728454|183168900|SUPERIORITY|||||||0.3591|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.3591
91638784|NCT01728454|183168900|SUPERIORITY|||||||0.0872|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.0872
91638785|NCT01728454|183168900|SUPERIORITY|||||||0.4814|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.4814
91638786|NCT01728454|183168900|SUPERIORITY|||||||0.9162|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.9162
91638787|NCT01728454|183168900|SUPERIORITY|||||||0.6607|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.6607
91638788|NCT01728454|183168900|SUPERIORITY|||||||0.9527|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.9527
91638789|NCT01728454|183168901|SUPERIORITY|||||||0.2812|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.2812
91638790|NCT01728454|183168901|SUPERIORITY|||||||0.5858|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.5858
91638791|NCT01728454|183168901|SUPERIORITY|||||||0.4116|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4116
91638792|NCT01728454|183168901|SUPERIORITY|||||||0.4252|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4252
91638793|NCT01728454|183168902|SUPERIORITY|||||||0.6131|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.6131
91638794|NCT01728454|183168902|SUPERIORITY|||||||0.7881|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.7881
91638795|NCT01728454|183168902|SUPERIORITY|||||||0.9376|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.9376
91638796|NCT01728454|183168902|SUPERIORITY|||||||0.6552|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.6552
91638797|NCT01728454|183168902|SUPERIORITY|||||||0.7143|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.7143
91638798|NCT01728454|183168902|SUPERIORITY|||||||0.2985|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.2985
91638799|NCT01728454|183168902|SUPERIORITY|||||||0.3162|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.3162
91638800|NCT01728454|183168902|SUPERIORITY|||||||0.7503|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.7503
91672537|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|65.07|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 11.||100.00|65.07|
91715883|NCT00830219|183322500|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.3||||||90.0|97.56|107.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.27|97.56|
91792922|NCT02477696|183463337|NON_INFERIORITY|Non-inferiority of acalabrutinib was demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) of the hazard ratio was below 1.429.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.79|1.27|||||Cox Proportional Hazards model stratified by 17p deletion status (yes versus no) and number of prior therapies (1-3 versus \>=4).|||1.27|0.79|
91638801|NCT00689299|183168903|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||ANOVA with baseline score as covariate||||<0.05
91638802|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.001
91638803|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.001
91638804|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.001
91638805|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.001
91638806|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
91638807|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.001
91638808|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.001
91638809|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.001
91638810|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
91638811|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
91638812|NCT01362062|183168935|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
91638813|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.003
91638814|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.005
91638815|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.002
91638816|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.014
91638817|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
91638818|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.008
91638819|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.014
91638820|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.009
91638821|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
91638822|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
91638823|NCT01362062|183168936|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
91638824|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.002
91638825|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
91638826|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.002
91638827|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
91715884|NCT00830219|183322501|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.54||||||90.0|97.53|107.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.8|97.53|
91715885|NCT01130272|183322502|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.457||||0.052|TWO_SIDED|95.0|0.994|6.077|||ANCOVA|||||6.077|0.994|0.052
91715886|NCT01130272|183322502|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.383||||0.041|TWO_SIDED|95.0|1.036|5.478|||ANCOVA|||||5.478|1.036|0.041
91715887|NCT01130272|183322502|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.079||||0.09|TWO_SIDED|95.0|0.893|4.842|||ANCOVA|||||4.842|0.893|0.090
91715888|NCT01130272|183322502|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.797||||0.015|TWO_SIDED|95.0|1.227|6.376|||ANCOVA|||||6.376|1.227|0.015
91715889|NCT01130272|183322503|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.719||||0.449|TWO_SIDED|95.0|0.306|1.689|||ANCOVA|||||1.689|0.306|0.449
91715890|NCT01130272|183322503|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.208||||0.583|TWO_SIDED|95.0|0.615|2.373|||ANCOVA|||||2.373|0.615|0.583
91715891|NCT01130272|183322503|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.014||||0.03|TWO_SIDED|95.0|1.069|3.795|||ANCOVA|||||3.795|1.069|0.030
91715892|NCT01130272|183322503|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.395||||0.326|TWO_SIDED|95.0|0.717|2.716|||ANCOVA|||||2.716|0.717|0.326
91792923|NCT02104739|183463349|SUPERIORITY|||||||0.27|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide at baseline and 2 hours after ingestion of meal is compared.||||0.27
91715893|NCT00641056|183322508|NON_INFERIORITY_OR_EQUIVALENCE|Power: 205 patients per treatment group would provide approximately 92% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|-0.29|-0.03||No adjustments for multiplicity were performed|Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference \[exenatide once weekly-insulin glargine\]\<0; noninferiority is concluded if this upper limit\<0.3%.||-0.03|-0.29|0.017
91715894|NCT00641056|183322509|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country served as the stratification factors.||||0.097
91715895|NCT00641056|183322510|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.||||0.002
91792924|NCT02104739|183463349|SUPERIORITY|||||||0.59|||||||Non-parametric Wilcoxon paired rank sum|||Saxagliptin at baseline and 2 hours after ingestion of meal is compared.||||0.59
91526414|NCT04078035|182927994|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.0033||0.002|TWO_SIDED|||||Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.|Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 15.64, p \< .001.||Results-interaction between time\^2 and condition||||0.002
91526415|NCT04078035|182927995|SUPERIORITY||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.0053||0.008|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results \_condition (stress/control) by time interactions.||||0.008
91715896|NCT00641056|183322511|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|0.25|1.0||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.00|0.25|0.001
91715897|NCT00641056|183322512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-4.57|-3.52||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||-3.52|-4.57|<.001
91715898|NCT00641056|183322513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.292|TWO_SIDED|95.0|-0.21|0.06||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.06|-0.21|0.292
91715899|NCT00641056|183322514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.377|TWO_SIDED|95.0|-0.05|0.02||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.02|-0.05|0.377
91715900|NCT00641056|183322515|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.04||0.077|TWO_SIDED|95.0|0.99|1.15||No adjustments for multiplicity were performed|Mixed Models Analysis|||Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.15|0.99|0.077
91792925|NCT02104739|183463349|SUPERIORITY|||||||0.51|||||||Non-parametric Wilcoxon paired rank sum|||Placebo at baseline and 2 hours after ingestion of meal is compared.||||0.51
91792926|NCT02104739|183463349|SUPERIORITY|||||||0.31|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.||||0.31
91792927|NCT02104739|183463351|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
91672538|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.41|||||TWO_SIDED|95.0|52.82|92.3|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 11.||92.30|52.82|
91672539|NCT02723773|183240105|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.0|||||TWO_SIDED|95.0|33.41|89.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 11.||89.77|33.41|
91672540|NCT02723773|183240106|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|64.75|96.79|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control \>=50 YOA Group and Historical Control\>=50 YOA Group.||96.79|64.75|
91672541|NCT02723773|183240106|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|46.59|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||100.00|46.59|
91672542|NCT02723773|183240106|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|50.0|||||TWO_SIDED|95.0|-860.45|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||99.15|-860.45|
91672543|NCT02723773|183240106|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.0|||||TWO_SIDED|95.0|53.66|95.95|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||95.95|53.66|
91672544|NCT02723773|183240106|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.96|||||TWO_SIDED|95.0|56.83|97.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||97.49|56.83|
91672545|NCT02723773|183240107|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.69|||||TWO_SIDED|95.0|78.67|95.7|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||95.70|78.67|
91672546|NCT02723773|183240107|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.79|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|77.79|
91672547|NCT02723773|183240107|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|74.75|||||TWO_SIDED|95.0|-155.17|99.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||99.49|-155.17|
91715901|NCT01811732|183322524|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|-2.6|||||TWO_SIDED|95.0|-8.8|3.6||||||||3.6|-8.8|
91526416|NCT04078035|182927996|SUPERIORITY||Slope|-0.0003|STANDARD_ERROR_OF_MEAN|0.0014||0.83|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.83
91792928|NCT02104739|183463353|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
91792929|NCT02104739|183463353|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
91638828|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
91638829|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
91638830|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
91638831|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
91672548|NCT02723773|183240107|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.24|||||TWO_SIDED|95.0|73.29|94.72|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||94.72|73.29|
91672549|NCT02723773|183240107|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.08|||||TWO_SIDED|95.0|73.87|95.41|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||95.41|73.87|
91672550|NCT02723773|183240108|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.67|||||TWO_SIDED|95.0|43.68|99.81|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||99.81|43.68|
91672551|NCT02723773|183240108|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-247.21|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control 60-69YOA Group over Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||100.00|-247.21|
91672552|NCT02723773|183240108|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.91|||||TWO_SIDED|95.0|37.45|99.79|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=60YOA Group over Historical Control \>=60YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ related complications between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||99.79|37.45|
91792930|NCT02104739|183463355|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
91638832|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
91792931|NCT02104739|183463357|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
91638833|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
91792932|NCT02104739|183463357|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
91792933|NCT02104739|183463359|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
91638834|NCT01362062|183168937|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
91638835|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
91638836|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
91638837|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
91638838|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
91638839|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
91638840|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
91638841|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
91638842|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
91638843|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
91638844|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
91792934|NCT02104739|183463360|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).||||>0.05
91792935|NCT02104739|183463360|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).||||>0.05
91792936|NCT03070444|183463368|OTHER|GEE analysis|GEE analysis|0.99||||0.0002|TWO_SIDED|95.0|0.48|1.51|||GEE analysis|||||1.51|0.48|0.0002
91792937|NCT03070444|183463369|OTHER|Mann-Whitney U test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91638845|NCT01362062|183168938|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
91638846|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
91638847|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
91638848|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
91638849|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
91638850|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
91638851|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
91638852|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
91672553|NCT02723773|183240108|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.89|||||TWO_SIDED|95.0|19.81|99.75|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=70YOA Group over Historical Control \>=70YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||99.75|19.81|
91638853|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
91672554|NCT02723773|183240109|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.83|||||TWO_SIDED|95.0|71.57|99.17|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||99.17|71.57|
91638854|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
91638855|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
91638856|NCT01362062|183168939|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
91715902|NCT00536510|183322547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.96|<|0.001||95.0|-18.6|-10.9||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The primary hypothesis of superiority of MK0524A 2 g to placebo in lowering Low Density Lipoprotein Cholesterol (LDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||-10.9|-18.6|<0.001
91638857|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.064|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.064
91638858|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.104|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.104
91638859|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.052|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.052
91638860|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.043|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.043
91638861|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB of Visit 7.||||=0.015
91638862|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.023
91638863|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.028|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.028
91638864|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.048|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.048
91638865|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.025|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.025
91638866|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.023
91638867|NCT01362062|183168940|SUPERIORITY_OR_OTHER||||||=|0.022|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.022
91638868|NCT02545504|183168951|SUPERIORITY||Cox Proportional Hazard|0.93||||0.5625|TWO_SIDED|95.0|0.74|1.18||The significance level at final analysis is 0.046 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by Eastern Cooperative Oncology Group (ECOG) status, geographic region and primary tumor site.|Hazard ratio (HR) was stratified by ECOG status, geographic region and primary tumor site with treatment arm as the only covariate.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.||1.18|0.74|0.5625
91638869|NCT02545504|183168952|SUPERIORITY||Cox Proportional Hazard|0.84||||0.1031|TWO_SIDED|95.0|0.67|1.04||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by ECOG status,geographic region and primary tumor site.|HR was stratified by ECOG status,geographic region;primary tumor site with treatment arm as a covariate.Stratum with \<6 participants or no informative event by combined treatment arms was pooled with smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.||1.04|0.67|0.1031
91672555|NCT02723773|183240109|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-1830.98|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 50-59YOA Group over Placebo/Historical Control 50-59YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|-1830.98|
91672556|NCT02723773|183240109|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|17.55|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 60-69YOA Group over Placebo/Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||100.00|17.55|
91638870|NCT02545504|183168953|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0493|TWO_SIDED|95.0|1.0|2.15||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Cochran-Mantel-Haenszel|p-value was stratified by ECOG status, geographic region and primary tumor site.|OR was stratified by ECOG status, geographic region and primary tumor site. Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.||2.15|1.00|0.0493
91638871|NCT02545504|183168953|SUPERIORITY||ORR Difference|9.4|||||TWO_SIDED|95.0|0.1|18.8|||||The 2-sided 95% confidence interval (CI) of difference for ORR between the treatment and placebo is calculated based on stratum-adjusted Cochran-Mantel-Haenszel proportion.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.||18.8|0.1|
91638872|NCT00434876|183168956|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Mixed Models Analysis|||||||0.49
91638873|NCT00434876|183168957|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
91638874|NCT00434876|183168958|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||Mixed Models Analysis|||||||0.57
91638875|NCT00434876|183168959|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||||||0.03
91638876|NCT00758394|183168960|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.|ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91638877|NCT00950755|183168961|SUPERIORITY_OR_OTHER||percentage of participants|76.0|||||TWO_SIDED|95.0|62.0|89.0|||||The estimated value represents the percentage of participants with response.|||89|62|
91638878|NCT00950755|183168962|SUPERIORITY_OR_OTHER||percentage of participants|54.0|||||TWO_SIDED|95.0|38.0|69.0|||||The estimated value represents the percentage of participants with confirmed response.|||69|38|
91672557|NCT02723773|183240109|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.28|||||TWO_SIDED|95.0|69.17|99.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||99.11|69.17|
91672558|NCT02723773|183240109|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.45|||||TWO_SIDED|95.0|60.93|98.91|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||98.91|60.93|
91672559|NCT01730040|183240163|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.1|||<|0.0001|TWO_SIDED|99.0|-55.9|-22.2|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-22.2|-55.9|< 0.0001
91672560|NCT01730040|183240163|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||=|0.0004|TWO_SIDED|99.0|-40.7|-6.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-6.5|-40.7|= 0.0004
91638879|NCT00950755|183168963|SUPERIORITY_OR_OTHER||percentage of participants|34.0|||||TWO_SIDED|95.0|20.0|49.0|||||The estimated value represents the percentage of participants with confirmed CR.|||49|20|
91638880|NCT00950755|183168964|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.0|57.0|||||The estimated value represents the percentage of participants with confirmed CR + CCR.|||57|26|
91638881|NCT00950755|183168965|SUPERIORITY_OR_OTHER||percentage of participants|10.0|||||TWO_SIDED|95.0|1.0|19.0|||||The estimated value represents the percentage of participants with confirmed PR.|||19|1|
91638882|NCT03539900|183168982|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.44|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a moderator or predictor.||||||.44
91638883|NCT03539900|183168983|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.04|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a predictor or moderator.||||||.04
91638884|NCT03539900|183168984|SUPERIORITY|||||||0.98|||||||ANOVA|Analyses used all available data without imputation.||||||.98
91638885|NCT03539900|183168985|SUPERIORITY|||||||0.44|||||||ANOVA|Analyses used all available data without imputation.||||||.44
91638886|NCT03539900|183168986|SUPERIORITY|||||||0.99|||||||ANOVA|Analyses used all available data without imputation.||||||.99
91672561|NCT01730040|183240163|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|99.0|-65.0|-33.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-33.5|-65|< 0.0001
91792938|NCT01373489|183463370|SUPERIORITY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91792939|NCT02582255|183463371|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
91792940|NCT02582255|183463372|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
91792941|NCT02582255|183463373|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
91792942|NCT02582255|183463374|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
91792943|NCT01709578|183463375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.711|||<|0.0001|TWO_SIDED|95.0|1.73|4.247||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||4.247|1.730|<0.0001
91638887|NCT03539900|183168987|SUPERIORITY|||||||0.4|||||||ANOVA|Analyses used all available data without imputation.||||||.40
91638888|NCT03159455|183169030|OTHER||Slope|2.2305|STANDARD_ERROR_OF_MEAN|0.2592|||TWO_SIDED|95.0|1.6955|2.7655|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC0-24 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.7655|1.6955|
91638889|NCT03159455|183169031|OTHER||Slope|1.9007|STANDARD_ERROR_OF_MEAN|0.2382|||TWO_SIDED|95.0|1.4102|2.3912|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3912|1.4102|
91638890|NCT03159455|183169032|OTHER||Slope|3.244|STANDARD_ERROR_OF_MEAN|0.1771|||TWO_SIDED|95.0|2.8793|3.6087|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for AUC0-24,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|3.6087|2.8793|
91638891|NCT03159455|183169033|OTHER||Slope|2.0711|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|1.7663|2.376|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for Cmax,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3760|1.7663|
91638892|NCT02022566|183169043|OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91638893|NCT02022566|183169044|OTHER|Described elsewhere|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
91638894|NCT03799198|183169058|SUPERIORITY||Treatment Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-5.51|-1.5|||ANCOVA|||Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.||-1.50|-5.51|<0.001
91638895|NCT00960869|183169076|SUPERIORITY_OR_OTHER||proportions|2.7||||0.005|TWO_SIDED|95.0|1.1|5.5|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||5.5|1.1|0.005
91638896|NCT00960869|183169077|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
91638897|NCT00960869|183169078|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
91638898|NCT00960869|183169079|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
91638899|NCT00960869|183169080|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
91638900|NCT03410693|183169085|SUPERIORITY||ORR difference (R-C)|-2.1|||=|0.6991|TWO_SIDED|95.0|-14.0|9.9|||Fisher Exact|||||9.9|-14.0|=0.6991
91638901|NCT03410693|183169085|SUPERIORITY||ORR difference (R - C)|-4.5|||=|0.7944|TWO_SIDED|95.0|-18.9|9.9|||Fisher Exact|||||9.9|-18.9|=0.7944
91638902|NCT03410693|183169086|SUPERIORITY||DCR difference (R-C)|-5.1|||=|0.7962|TWO_SIDED|95.0|-19.9|9.7|||Fisher Exact|||||9.7|-19.9|=0.7962
91638903|NCT03410693|183169086|SUPERIORITY||DCR difference (R-C)|-10.3|||=|0.9109|TWO_SIDED|95.0|-27.5|6.9|||Fisher Exact|||||6.9|-27.5|=0.9109
91672562|NCT01730040|183240163|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-48.4|-16.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.9|-48.4|< 0.0001
91485547|NCT00406354|182844236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.8|-2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-2.0|-5.8|<.001
91485548|NCT00406354|182844237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.2|-0.6|<.001
91526417|NCT04078035|182927997|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0033||0.03|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.03
91638904|NCT03410693|183169087|SUPERIORITY||Hazard Ratio (HR)|1.226|||=|0.8672|TWO_SIDED|95.0|0.853|1.762|||Log Rank|||||1.762|0.853|= 0.8672
91672563|NCT01730040|183240163|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|99.0|-47.4|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-47.4|<0.0001
91672564|NCT01730040|183240164|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.5|||<|0.0001|TWO_SIDED|99.0|-59.2|-25.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.||-25.7|-59.2|< 0.0001
91672565|NCT01730040|183240164|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||=|0.0002|TWO_SIDED|99.0|-41.9|-7.8||Threshold for significance≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.8|-41.9|= 0.0002
91672566|NCT01730040|183240164|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|99.0|-69.2|-36.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-36.5|-69.2|< 0.0001
91672567|NCT01730040|183240164|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|99.0|-51.3|-18.6|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-51.3|< 0.0001
91672568|NCT01730040|183240164|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.4|||<|0.0001|TWO_SIDED|99.0|-50.0|-16.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.8|-50.0|< 0.0001
91638905|NCT03410693|183169087|SUPERIORITY||Hazard Ratio (HR)|1.341||||0.9171|TWO_SIDED|95.0|0.88|2.043|||Log Rank|||||2.043|0.880|0.9171
91638906|NCT02687815|183169097|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.63|TWO_SIDED|95.0|0.69|1.85|||Regression, Cox|||||1.85|0.69|0.63
91672569|NCT01730040|183240165|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|99.0|-54.0|-25.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.6|-54|<0.0001
91672570|NCT01730040|183240165|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|99.0|-40.0|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.0|<0.0001
91672571|NCT01730040|183240165|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.0|||<|0.0001|TWO_SIDED|99.0|-47.7|-24.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.3|-47.7|<0.0001
91672572|NCT01730040|183240165|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-39.2|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-39.2|<0.0001
91672573|NCT01730040|183240165|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.9|||<|0.0001|TWO_SIDED|99.0|-32.8|-8.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.9|-32.8|<0.0001
91672574|NCT01730040|183240166|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|99.0|-55.8|-33.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-33.1|-55.8|<0.0001
91672575|NCT01730040|183240166|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-38.0|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-38.0|<0.0001
91638907|NCT02687815|183169098|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.46|TWO_SIDED|95.0|0.63|2.75|||Regression, Cox|||||2.75|0.63|0.46
91638908|NCT02687815|183169099|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.66|1.52|||Regression, Logistic|||||1.52|0.66|0.99
91672576|NCT01730040|183240166|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.3|||<|0.0001|TWO_SIDED|99.0|-48.1|-24.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.5|-48.1|<0.0001
91672577|NCT01730040|183240166|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.0001|TWO_SIDED|99.0|-39.6|-15.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.8|-39.6|<0.0001
91672578|NCT01730040|183240166|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.2|||<|0.0001|TWO_SIDED|99.0|-32.2|-8.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-32.2|<0.0001
91672579|NCT01730040|183240167|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-42.0|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.6|-42.0|<0.0001
91638909|NCT02687815|183169100|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.049|TWO_SIDED|95.0|0.001|8.8|||Regression, Linear|||||8.80|0.001|0.049
91715903|NCT00536510|183322548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.9|STANDARD_ERROR_OF_MEAN|1.68|<|0.001||95.0|12.6|19.2||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The secondary hypothesis of superiority of MK0524A 2 g to placebo in lowering High Density Lipoprotein Cholesterol (HDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||19.2|12.6|<0.001
91715904|NCT02035553|183322549|SUPERIORITY||Diff in MMRM LSM|-1.84||||0.0451|TWO_SIDED|95.0|-3.64|-0.04|||Mixed Models Analysis|||||-0.04|-3.64|0.0451
91715905|NCT04539964|183322550|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|11.8||||0.0209|TWO_SIDED|95.0|0.6|23.1||The study is considered successful if there is a statistically significant improvement in the proportion of subjects with ACR20 response in favor of the SetPoint System at the one-sided alpha of 0.025.|Cochran-Mantel-Haenszel|||||23.1|0.6|0.0209
91715906|NCT04539964|183322551|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|19.5||||0.0048|TWO_SIDED|95.0|7.3|31.7||Adjusted p-value. Hochberg's step-up procedure was used to control the family wise type 1 error rate at a 1-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||31.7|7.3|0.0048
91715907|NCT04539964|183322552|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|13.2||||0.0528|TWO_SIDED|95.0|1.1|25.3||Adjusted p-value. Hochberg's step-up procedure was used to control the family wise type 1 error rate at a 1-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||25.3|1.1|0.0528
91715908|NCT04539964|183322553|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|9.0||||0.0797|TWO_SIDED|95.0|-3.3|21.4||Adjusted p-value. Hochberg's step-up procedure was used to control the family wise type 1 error rate at a 1-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||21.4|-3.3|0.0797
91715909|NCT04539964|183322554|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|8.0||||0.0797|TWO_SIDED|95.0|-3.1|19.0||Adjusted p-value. Hochberg's step-up procedure was used to control the family wise type 1 error rate at a 1-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||19.0|-3.1|0.0797
91715910|NCT04539964|183322555|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that control group response rate exceeds the treatment group response rate.|Risk Difference (RD)|-3.7||||0.2476|TWO_SIDED|95.0|-14.4|7.0|||Cochran-Mantel-Haenszel|||||7.0|-14.4|0.2476
91715911|NCT04539964|183322556|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that control group response rate exceeds the treatment group response rate.|Risk Difference (RD)|-20.2||||0.0156|TWO_SIDED|95.0|-38.1|-2.2|||Cochran-Mantel-Haenszel|||||-2.2|-38.1|0.0156
91715912|NCT04539964|183322557|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that control group response rate exceeds the treatment group response rate.|Risk Difference (RD)|-18.6||||0.0099|TWO_SIDED|95.0|-34.7|-2.6|||Cochran-Mantel-Haenszel|||||-2.6|-34.7|0.0099
91715913|NCT04539964|183322558|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.3||||0.0618|TWO_SIDED|95.0|-0.8|0.1|||Mixed Models Analysis|||||0.1|-0.8|0.0618
91715914|NCT04539964|183322559|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.9||||0.0308|TWO_SIDED|95.0|-1.8|0.0|||Mixed Models Analysis|||||0.0|-1.8|0.0308
91715915|NCT04539964|183322560|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.8||||0.0441|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.0441
91715916|NCT04539964|183322561|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.1||||0.2871|TWO_SIDED|95.0|-0.6|0.3|||Mixed Models Analysis|||||0.3|-0.6|0.2871
91715917|NCT04539964|183322562|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.1||||0.4345|TWO_SIDED|95.0|-0.9|0.7|||Mixed Models Analysis|||||0.7|-0.9|0.4345
91715918|NCT04539964|183322563|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.45||||0.09|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||||0.2|-1.1|0.0900
91715919|NCT04539964|183322564|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-0.7||||0.0662|TWO_SIDED|95.0|-1.7|0.2|||Mixed Models Analysis|||||0.2|-1.7|0.0662
91715920|NCT04539964|183322565|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-1.8||||0.045|TWO_SIDED|95.0|-3.9|0.3|||Mixed Models Analysis|||||0.3|-3.9|0.0450
91485549|NCT00406354|182844238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.4|-0.1||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.1|-0.4|0.006
91672580|NCT01730040|183240167|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|99.0|-36.6|-10.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-10.7|-36.6|<0.0001
91672581|NCT01730040|183240167|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|99.0|-50.8|-26.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-26.0|-50.8|<0.0001
91672582|NCT01730040|183240167|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|||<|0.0001|TWO_SIDED|99.0|-43.2|-18.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-43.2|<0.0001
91672583|NCT01730040|183240167|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|99.0|-40.1|-15.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.1|-40.1|<0.0001
91672584|NCT01730040|183240168|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-44.6|-20.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.6|-44.6|<0.0001
91672585|NCT01730040|183240168|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|99.0|-37.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-37.3|<0.0001
91672586|NCT01730040|183240168|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.3|||<|0.0001|TWO_SIDED|99.0|-51.2|-25.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-25.4|-51.2|<0.0001
91672587|NCT01730040|183240168|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|99.0|-42.6|-17.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.1|-42.6|<0.0001
91672588|NCT01730040|183240168|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|99.0|-39.4|-13.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.4|-39.4|<0.0001
91672589|NCT01730040|183240169|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|99.0|-44.7|-16.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.1|-44.7|<0.0001
91485550|NCT00406354|182844239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.2|-0.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.9|-6.2|0.010
91672590|NCT01730040|183240169|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.6|||=|0.0002|TWO_SIDED|99.0|-36.1|-7.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.1|-36.1|=0.0002
91672591|NCT01730040|183240169|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.1|||<|0.0001|TWO_SIDED|99.0|-54.7|-27.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-27.5|-54.7|<0.0001
91672592|NCT01730040|183240169|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2|||<|0.0001|TWO_SIDED|99.0|-43.7|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.6|-43.7|<0.0001
91672593|NCT01730040|183240169|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-40.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-40.3|<0.0001
91672594|NCT01730040|183240170|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.0|||<|0.0001|TWO_SIDED|99.0|-47.0|-19.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-19.0|-47.0|<0.0001
91672595|NCT01730040|183240170|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|99.0|-36.6|-8.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.1|-36.6|<0.0001
91485551|NCT00406354|182844240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.01|TWO_SIDED|95.0|-3.2|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-3.2|0.010
91672596|NCT01730040|183240170|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|99.0|-57.4|-29.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-29.7|-57.4|<0.0001
91672597|NCT01730040|183240170|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.1|||<|0.0001|TWO_SIDED|99.0|-46.0|-18.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.3|-46.0|<0.0001
91672598|NCT01730040|183240170|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-41.4|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.2|-41.4|<0.0001
91672599|NCT01730040|183240171|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|99.0|-32.9|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.2|-32.9|<0.0001
91672600|NCT01730040|183240171|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-25.8|-5.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-5.8|-25.8|<0.0001
91672601|NCT01730040|183240171|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.9|||<|0.0001|TWO_SIDED|99.0|-39.4|-18.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.4|-39.4|<0.0001
91638910|NCT02558634|183169104|SUPERIORITY||Median Difference (Final Values)|1.25||||0.025|TWO_SIDED|95.0|0.75|1.75||The level of significance was set at p=0.025 to allow a Bonferroni correction for these two tests (i.e. p=0.050 divided by two).|Wilcoxon (Mann-Whitney)|||||1.75|0.75|0.025
91672602|NCT01730040|183240171|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.9|||<|0.0001|TWO_SIDED|99.0|-32.4|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-32.4|<0.0001
91485552|NCT00406354|182844241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.406|TWO_SIDED|95.0|-4.9|2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Negative values are in favor of the atomoxetine arms.|||2.0|-4.9|0.406
91672603|NCT01730040|183240171|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.4|||<|0.0001|TWO_SIDED|99.0|-29.1|-7.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-29.1|<0.0001
91672604|NCT01730040|183240172|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|99.0|-41.6|-21.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.3|-41.6|<0.0001
91672605|NCT01730040|183240172|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|99.0|-35.4|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-35.4|<0.0001
91638911|NCT01798056|183169124|NON_INFERIORITY|Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.|Adjusted GMC ratio|23.2|||||TWO_SIDED|95.0|17.9|30.0||||Difference of means between vaccines and placebo were calculated together with 2-sided confidence intervals and back-transformed to the original units||The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).||30|17.9|
91638912|NCT01008059|183169153|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91638913|NCT02660489|183169154|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91638914|NCT02660489|183169155|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
91638915|NCT02660489|183169156|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
91638916|NCT02660489|183169157|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91638917|NCT02660489|183169158|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91672606|NCT01730040|183240172|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|||<|0.0001|TWO_SIDED|99.0|-35.9|-17.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-35.9|<0.0001
91672607|NCT01730040|183240172|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.2|||<|0.0001|TWO_SIDED|99.0|-31.5|-12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.9|-31.5|<0.0001
91672608|NCT01730040|183240172|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.9|||<|0.0001|TWO_SIDED|99.0|-25.2|-6.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-6.6|-25.2|<0.0001
91672609|NCT01730040|183240173|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.5|||<|0.0001|TWO_SIDED|99.0|-45.3|-21.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.6|-45.3|<0.0001
91672610|NCT01730040|183240173|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.4|||<|0.0001|TWO_SIDED|99.0|-35.2|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-35.2|<0.0001
91638918|NCT02660489|183169159|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91638919|NCT02660489|183169160|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
91638920|NCT02660489|183169161|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
91638921|NCT02322866|183169162|SUPERIORITY||Least Squares Mean Difference|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-2.9|-5.8|< 0.0001
91638922|NCT02322866|183169163|SUPERIORITY||Treatment Rate Difference|7.3||||0.0038|TWO_SIDED|95.0|2.53|12.07||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||12.07|2.53|0.0038
91638923|NCT02322866|183169164|SUPERIORITY||Least Squares Mean Difference|-14.4|||<|0.0001|TWO_SIDED|95.0|-19.4|-9.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-9.5|-19.4|< 0.0001
91638924|NCT02322866|183169165|SUPERIORITY||Least Squares Mean Difference|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-7.9|-17.3|< 0.0001
91638925|NCT02322866|183169166|SUPERIORITY||Least Squares Mean Difference|-11.8|||<|0.0001|TWO_SIDED|95.0|-16.1|-7.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-7.5|-16.1|< 0.0001
91638926|NCT02322866|183169167|SUPERIORITY||Least Squares Mean Difference|-9.4|||<|0.0001|TWO_SIDED|95.0|-13.5|-5.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-5.3|-13.5|< 0.0001
91638927|NCT02322866|183169168|SUPERIORITY||Least Squares Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.2|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.2|< 0.0001
91485553|NCT00406354|182844242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
91672611|NCT01730040|183240173|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-39.0|-19.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.6|-39.0|<0.0001
91672612|NCT01730040|183240173|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|99.0|-32.3|-12.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.7|-32.3|<0.0001
91672613|NCT01730040|183240173|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.8|||<|0.0001|TWO_SIDED|99.0|-24.7|-4.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-4.9|-24.7|<0.0001
91672614|NCT01730040|183240174|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.6|||<|0.0001|TWO_SIDED|99.0|-31.4|-13.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.8|-31.4|<0.0001
91672615|NCT01730040|183240174|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-24.6|-7.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.0|-24.6|<0.0001
91672616|NCT01730040|183240174|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.1|||<|0.0001|TWO_SIDED|99.0|-26.9|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-26.9|<0.0001
91672617|NCT01730040|183240174|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|99.0|-23.3|-7.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.6|-23.3|<0.0001
91672618|NCT01730040|183240174|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8|||=|0.0015|TWO_SIDED|99.0|-17.7|-1.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-1.9|-17.7|=0.0015
91672619|NCT01730040|183240175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.7|||<|0.0001|TWO_SIDED|99.0|3.9|71.7||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.7|3.9|<0.0001
91485554|NCT00406354|182844243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
91672620|NCT01730040|183240175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||=|0.0284|TWO_SIDED|99.0|0.8|14.6||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||14.6|0.8|=0.0284
91672621|NCT01730040|183240175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|83.2|||<|0.0001|TWO_SIDED|99.0|11.6|596.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||596.8|11.6|<0.0001
91672622|NCT01730040|183240175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2|||=|0.0025|TWO_SIDED|99.0|1.3|38.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||38.3|1.3|=0.0025
91672623|NCT01730040|183240175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1|||=|0.0011|TWO_SIDED|99.0|1.6|52.2||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||52.2|1.6|=0.0011
91672624|NCT01730040|183240176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|128.4|||<|0.0001|TWO_SIDED|99.0|14.2|1157.0||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1157|14.2|<0.0001
91672625|NCT01730040|183240176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.9|||=|0.0015|TWO_SIDED|99.0|1.6|75.4||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||75.4|1.6|=0.0015
91672626|NCT01730040|183240176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.7|||=|0.0008|TWO_SIDED|99.0|1.8|101.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||101.1|1.8|=0.0008
91672627|NCT01730040|183240177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|116.8|||<|0.0001|TWO_SIDED|99.0|14.7|927.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||927.5|14.7|<0.0001
91672628|NCT01730040|183240177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.2|||<|0.0001|TWO_SIDED|99.0|2.5|68.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||68.8|2.5|<0.0001
91672629|NCT01730040|183240177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.9|||=|0.0004|TWO_SIDED|99.0|1.9|51.9||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||51.9|1.9|=0.0004
91672630|NCT01730040|183240178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|162.1|||<|0.0001|TWO_SIDED|99.0|17.3|1520.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1520.5|17.3|<0.0001
91672631|NCT01730040|183240178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.8|||<|0.0001|TWO_SIDED|99.0|3.1|126.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||126.3|3.1|<0.0001
91672632|NCT01730040|183240178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||=|0.0002|TWO_SIDED|99.0|2.2|88.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||88.1|2.2|=0.0002
91485555|NCT00406354|182844244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
91485556|NCT00406354|182844245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.2||0.021|TWO_SIDED|95.0|0.8|9.3||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||9.3|0.8|0.021
91638928|NCT02322866|183169169|SUPERIORITY||Least Squares Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.4|-5.0|< 0.0001
91638929|NCT02322866|183169170|SUPERIORITY||Least Squares Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-1.7|-4.1|< 0.0001
91638930|NCT02145949|183169185|OTHER|||||||0.03|||||||ANCOVA|||||||.03
91638931|NCT02145949|183169186|OTHER|||||||0.01|||||||ANCOVA|||||||.01
91638932|NCT02145949|183169187|OTHER|||||||0.04|||||||ANCOVA|||||||.04
91638933|NCT02145949|183169188|OTHER|||||||0.01|||||||ANCOVA|||||||.01
91638934|NCT02145949|183169189|OTHER|||||||0.12|||||||ANCOVA|||||||.12
91638935|NCT02145949|183169190|OTHER|||||||0.03|||||||ANCOVA|||||||.03
91638936|NCT02145949|183169191|OTHER|||||||0.71|||||||ANCOVA|||||||.71
91638937|NCT02145949|183169192|OTHER|||||||0.76|||||||ANCOVA|||||||.76
91638938|NCT02145949|183169193|OTHER|||||||0.4|||||||ANCOVA|||||||.40
91485557|NCT00406354|182844246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.1||0.017|TWO_SIDED|95.0|-13.8|-1.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||-1.4|-13.8|0.017
91485558|NCT00406354|182844247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|2.8||0.05|TWO_SIDED|95.0|0.0|10.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||10.9|-0.0|0.050
91638939|NCT02145949|183169194|OTHER|||||||0.97|||||||ANCOVA|||||||.97
91638940|NCT02145949|183169195|OTHER|||||||0.89|||||||ANCOVA|||||||.89
91638941|NCT02145949|183169196|OTHER|||||||0.48|||||||ANCOVA|||||||.48
91638942|NCT02145949|183169197|OTHER|||||||0.02|||||||ANCOVA|||||||.02
91638943|NCT02145949|183169198|OTHER|||||||0.29|||||||ANCOVA|||||||.29
91638944|NCT02145949|183169199|OTHER|||||||0.33|||||||ANCOVA|||||||.33
91638945|NCT02145949|183169200|OTHER|||||||0.3|||||||ANCOVA|||||||.30
91638946|NCT02145949|183169201|OTHER|||||||0.98|||||||ANCOVA|||||||.98
91638947|NCT02145949|183169202|OTHER|||||||0.18|||||||ANCOVA|||||||.18
91638948|NCT02145949|183169203|OTHER|||||||0.52|||||||ANCOVA|||||||.52
91638949|NCT02145949|183169204|OTHER|||||||0.81|||||||ANCOVA|||||||.81
91638950|NCT04602078|183169229|SUPERIORITY|||||||0.444|||||||Log Rank|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.444
91638951|NCT04602078|183169230|SUPERIORITY|||||||0.414|||||||Chi-squared|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.414
91638952|NCT02452320|183169247|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
91638953|NCT03737812|183169251|OTHER|a statistical test was not performed|Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.485|10.259||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||10.259|0.485|
91638954|NCT03737812|183169251|OTHER|a statistical test was not performed|Odds Ratio (OR)|3.859|||||TWO_SIDED|95.0|0.899|16.561||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||16.561|0.899|
91638955|NCT01474291|183169263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.023|TWO_SIDED|95.0|1.06|2.3|||Wald Chi-square|Wald Chi-square Test for Type 3 generalized estimating equation (GEE) Analysis.||"Influence of baseline factor Patient's Age (\>=65) upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||2.30|1.06|0.0230
91638956|NCT01474291|183169263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.92|8.43|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor No methotrexate (MTX) sequences within the two last years upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||8.43|3.92|<0.0001
91638957|NCT01474291|183169263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0212|TWO_SIDED|95.0|1.11|3.7|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Past history of severe infectious disease upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||3.70|1.11|0.0212
91638958|NCT01474291|183169263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0076|TWO_SIDED|95.0|1.05|1.41|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Higher Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) (unit=1) on physician decision to initiate tocilizumab monotherapy; DAS28-ESR was calculated from the number of swollen joints and tender joints using 28-joint count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity; scores range from 0 to 10; higher scores correspond to greater disease activity (multivariate analysis)."||1.41|1.05|0.0076
91638959|NCT03471507|183169285|OTHER|||||||0.46|||||||Regression, Linear|Adjusted for age and sex.||||||0.46
91485559|NCT00406354|182844248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.9|16.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||16.4|4.9|<.001
91672633|NCT01730040|183240179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.1|||=|0.0004|TWO_SIDED|99.0|-36.3|-5.9||Threshold for significance ≤ 0.01.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.9|-36.3|=0.0004
91672634|NCT01730040|183240179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.9|||<|0.0001|TWO_SIDED|99.0|-40.2|-11.6||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.2|<0.0001
91672635|NCT01730040|183240179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.0|||<|0.0001|TWO_SIDED|99.0|-45.6|-16.4||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-45.6|<0.0001
91672636|NCT01730040|183240180|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||=|0.4456|TWO_SIDED|99.0|-7.0|12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).||12.9|-7.0|=0.4456
91672637|NCT03407612|183240187|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.67|||||||t-test, 2 sided|||This analysis considers the baseline HOS-ADL measures.||||0.67
91672638|NCT03407612|183240187|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.73|||||||t-test, 2 sided|||This analysis considers the 6 week postoperative HOS-ADL measures.||||0.73
91672639|NCT03407612|183240187|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.87|||||||t-test, 2 sided|||This analysis considers the 12 week postoperative HOS-ADL measures.||||0.87
91715921|NCT04539964|183322566|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that the control group mean change exceeds the treatment group mean change.|Mean Difference (Net)|-1.55||||0.035|TWO_SIDED|95.0|-3.2|0.1|||Mixed Models Analysis|||||0.1|-3.2|0.0350
91672640|NCT03407612|183240187|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.78|||||||t-test, 2 sided|||This analysis considers the 6 month postoperative HOS-ADL measures.||||0.78
91672641|NCT03407612|183240188|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.25|||||||t-test, 2 sided|||||||0.25
91485560|NCT00406354|182844249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|3.3||0.015|TWO_SIDED|95.0|1.6|14.6||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||14.6|1.6|0.015
91672642|NCT03407612|183240189|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.04|||||||t-test, 2 sided|||||||0.04
91672643|NCT01552369|183240193|SUPERIORITY|||||||0.0396|||||||Mantel Haenszel|||||||0.0396
91672644|NCT01552369|183240193|SUPERIORITY||Hazard Ratio (HR)|2.22||||0.048|TWO_SIDED|95.0|1.01|7.3|||Competing risk regression|Death was considered a competing risk.|The risk of CMV disease is 2.2x higher in the prophylaxis group when compared to the preemptive group|||7.3|1.01|0.048
91672645|NCT01552369|183240194|SUPERIORITY|log-rank test for equality of survivor functions||||||0.19|||||||Log Rank|||||||0.19
91672646|NCT01552369|183240195|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.45|1.58|||Mantel Haenszel||The odds of rejection in prophylaxis group compared to preemptive group|||1.58|0.45|0.60
91672647|NCT01552369|183240196|SUPERIORITY||Odds Ratio (OR)|0.95||||0.96|TWO_SIDED|95.0|0.13|6.92|||Mantel Haenszel||The odds of graft loss in prophylaxis group compared to preemptive group|||6.92|0.13|0.96
91672648|NCT01552369|183240197|SUPERIORITY||Odds Ratio (OR)|3.24||||0.014|TWO_SIDED|95.0|1.21|8.69|||Mantel Haenszel||Odds of late disease in prophylaxis group compared to preemptive|||8.69|1.21|0.014
91672649|NCT01552369|183240198|SUPERIORITY||Odds Ratio (OR)|1.17||||0.64|TWO_SIDED|95.0|0.61|2.23|||Mantel Haenszel||Odds of bacterial infection in prophylaxis subjects compared to preemptive|||2.23|0.61|0.64
91672650|NCT01552369|183240199|SUPERIORITY||Odds Ratio (OR)|2.25||||0.18|TWO_SIDED|95.0|0.66|7.62|||Mantel Haenszel||Odds of fungal disease in prophylaxis group compared to preemptive|||7.62|0.66|0.18
91672651|NCT01552369|183240200|SUPERIORITY|||||||0.24|||||||Fisher Exact|||||||0.24
91672652|NCT01552369|183240201|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
91672653|NCT01552369|183240202|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
91672654|NCT01552369|183240203|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
91672655|NCT01221090|183240205|SUPERIORITY_OR_OTHER|||||||0.771||95.0||||A priori threshold for statistical significance is \<0.05|Likelihood Ratio Tests|||We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time \& treatment effects were added gradually and evaluated with likelihood ratio tests.||||0.771
91672656|NCT01221090|183240206|SUPERIORITY_OR_OTHER|||||||0.2176||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimates.||||||0.2176
91672657|NCT01221090|183240207|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||A priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.572
91672658|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar."||||0.26
91672659|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times."||||0.21
91672660|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes."||||0.53
91792944|NCT01709578|183463375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.108|5.115||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.115|2.108|<0.0001
91672661|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session."||||0.24
91672662|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet."||||0.18
91672663|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet."||||0.19
91672664|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet."||||0.87
91672665|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes."||||0.53
91672666|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes."||||0.32
91672667|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan."||||0.37
91715922|NCT04539964|183322567|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|7.8||||0.0648|TWO_SIDED|95.0|-2.1|17.7|||Cochran-Mantel-Haenszel|||||17.7|-2.1|0.0648
91715923|NCT04539964|183322568|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|11.4||||0.0154|TWO_SIDED|95.0|1.2|21.6|||Cochran-Mantel-Haenszel|||||21.6|1.2|0.0154
91715924|NCT04539964|183322612|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|25.2||||0.0054|TWO_SIDED|95.0|7.1|43.3|||Cochran-Mantel-Haenszel|||||43.3|7.1|0.0054
91672668|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates."||||0.72
91672669|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables."||||0.59
91672670|NCT01221090|183240208|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods."||||<0.004
91672671|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts)."||||0.66
91672672|NCT01221090|183240208|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan."||||0.68
91672673|NCT01221090|183240209|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust Variance Estimation.||"This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit."||||0.685
91672674|NCT01221090|183240209|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days mental health was not good in the past 30 days at the 12 month follow-up visit."||||0.997
91672675|NCT01221090|183240209|SUPERIORITY_OR_OTHER|||||||0.3067||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days poor physical/mental health prevented usual activity in the past 30 days at the 12 month follow-up visit."||||0.3067
91672676|NCT00440466|183240226|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.|Difference of Least Squares Means|-0.03|STANDARD_ERROR_OF_MEAN|0.092|||TWO_SIDED|95.0|-0.208|0.153|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.153|-0.208|
91715925|NCT04539964|183322613|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|20.3||||0.0437|TWO_SIDED|95.0|-2.2|42.9|||Cochran-Mantel-Haenszel|||||42.9|-2.2|0.0437
91792945|NCT01709578|183463376|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.202||||0.0007|TWO_SIDED|95.0|-0.318|-0.086||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.086|-0.318|0.0007
91792946|NCT01709578|183463376|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.0004|TWO_SIDED|95.0|-0.325|-0.095||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.095|-0.325|0.0004
91638960|NCT02046993|183169323|SUPERIORITY_OR_OTHER|||||||0.27|||||||Chi-squared|||comparison of the percentage of patients doing HBPM between intervention and control group at baseline||||0.27
91638961|NCT02046993|183169323|SUPERIORITY_OR_OTHER|||||||0.02|||||||McNemar|||Comparison of percentage of subjects doing HBPM at 3rd month from baseline within intervention group||||.020
91485561|NCT00406354|182844250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.018|TWO_SIDED|95.0|1.4|14.7||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive results are in favor of the atomoxetine arms.|||14.7|1.4|0.018
91638962|NCT02046993|183169323|SUPERIORITY_OR_OTHER|||||||0.06|||||||McNemar|||comparison in percentage of patients doing Home BP monitoring at 6th month from baseline within intervention group||||.060
91638963|NCT02046993|183169323|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||McNemar|||Change in the proportion of patients doing HBPM at 3 months from baseline within the control group||||.002
91638964|NCT02046993|183169323|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||McNemar|||Change in proportion of patients doing HBPM at 6 months from baseline within control group||||.009
91638965|NCT02046993|183169324|SUPERIORITY_OR_OTHER|||||||0.813|||||||t-test, 2 sided|||Comparison of baseline mean clinic systolic BP mCSBP readings between control and intervention||||0.813
91638966|NCT02046993|183169324|SUPERIORITY_OR_OTHER|||||||0.865|||||||t-test, 2 sided|||Comparison of baseline mean clinic diastolic BP mCDBP readings between control and intervention||||0.865
91638967|NCT02046993|183169324|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline||||0.476
91638968|NCT02046993|183169324|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline||||0.14
91638969|NCT02046993|183169324|SUPERIORITY_OR_OTHER|||||||0.495|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline||||0.495
91638970|NCT02046993|183169324|SUPERIORITY_OR_OTHER|||||||0.967|||||||t-test, 2 sided|||Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline||||0.967
91638971|NCT02046993|183169325|SUPERIORITY_OR_OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baselline SEMCD between telemonitoring group and enhanced usual care||||0.819
91638972|NCT02046993|183169325|SUPERIORITY_OR_OTHER|||||||0.512|||||||t-test, 2 sided|||Comparison of SEMCD at 3 months between telemonitoring group and enhanced usual care||||0.512
91638973|NCT02046993|183169325|SUPERIORITY_OR_OTHER|||||||0.325|||||||t-test, 2 sided|||Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group||||0.325
91638974|NCT02046993|183169326|SUPERIORITY_OR_OTHER|||||||0.532|||||||t-test, 2 sided|||comparison of baseline mHSBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.532
91638975|NCT02046993|183169326|SUPERIORITY_OR_OTHER|||||||0.902|||||||t-test, 2 sided|||comparison of baseline mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.902
91638976|NCT02046993|183169327|SUPERIORITY_OR_OTHER|||||||0.138|||||||t-test, 2 sided|||comparison of mHSBP at 3 months between smartphone based telemonitoring group and control group on enhanced usual care||||0.138
91638977|NCT02046993|183169327|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups at 3 months||||0.204
91638978|NCT02046993|183169328|SUPERIORITY_OR_OTHER|||||||0.199|||||||t-test, 2 sided|||comparison of mHSBP in mmHg between Telemonitoring groups and Enhanced Usual Care groups at 6 months||||0.199
91638979|NCT02046993|183169328|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg at 6 months between Telemonitoring and Enhanced Usual Care groups||||0.204
91638980|NCT00851721|183169363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Two-sample, two-sided t-test|||H0: μ(on-demand) = μ(prophylaxis) Versus H1: μ(on-demand) ≠ μ(prophylaxis) (Where H0 implies no difference in mean bleeding episode rate between prophylaxis and on-demand treatment arms and H1 implies otherwise. This test was performed at a significance level of 5%, two-sided, two sample)||||0.0003
91638981|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Two-sample, two-sided t-test|||Spontaneous Bleeds||||0.0008
91638982|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|||||||Two-sample, two-sided t-test|||Traumatic Bleeds||||0.0199
91638983|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Two-sample, two-sided t-test|||Joint Bleeds||||0.0006
91638984|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227|||||||Two-sample, two-sided t-test|||Non-Joint Bleeds||||0.0227
91638985|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Two-sample, two-sided t-test|||Spontaneous Joint Bleeds||||0.0013
91638986|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Two-sample, two-sided t-test|||Spontaneous Non-Joint Bleeds||||0.0030
91638987|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254|||||||Two-sample, two-sided t-test|||Traumatic Joint Bleeds||||0.0254
91638988|NCT00851721|183169365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9322|||||||Two-sample, two-sided t-test|||Traumatic Non-Joint Bleeds||||0.9322
91638989|NCT00851721|183169367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271|||||||Two-sample, two-sided t-test|||||||0.0271
91638990|NCT00851721|183169374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||95.0|||||Mann-Whitney tests (Wilcoxon-Rank Sum)|||||||0.0067
91638991|NCT04047472|183169406|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.16||0.006|TWO_SIDED|90.0|-3.0|0.9|||ANOVA|||||0.9|-3.0|0.006
91638992|NCT04047472|183169407|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.009|TWO_SIDED|90.0|-3.2|0.5|||ANOVA|||||0.5|-3.2|0.009
91638993|NCT02347345|183169463|OTHER|Descriptive pilot study. Not relevant.||||||0.07|||||||Kruskal-Wallis|||||||0.07
91638994|NCT01333501|183169466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|2.7||0.494|TWO_SIDED|95.0|-3.51|7.23|||ANCOVA|||||7.23|-3.51|0.4940
91485562|NCT00406354|182844251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|3.3||0.138|TWO_SIDED|95.0|-1.6|11.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||11.5|-1.6|0.138
91485563|NCT00406354|182844252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.193||||0.016||95.0|1.16|4.146||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Log Rank|||||4.146|1.160|0.016
91485564|NCT00406354|182844253|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the initial three weeks of study treatment|Fisher Exact|||||||0.102
91638995|NCT01333501|183169467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.97|STANDARD_ERROR_OF_MEAN|3.03||0.5183|TWO_SIDED|95.0|-4.06|7.99|||ANCOVA|||||7.99|-4.06|0.5183
91638996|NCT01333501|183169468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.05||0.1334|TWO_SIDED|95.0|-3.69|0.5|||ANCOVA|||||0.50|-3.69|0.1334
91638997|NCT01333501|183169469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|2.29||0.4501|TWO_SIDED|95.0|-6.27|2.81|||ANCOVA|||||2.81|-6.27|0.4501
91638998|NCT01333501|183169470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|2.53||0.8561|TWO_SIDED|95.0|-4.57|5.49|||ANCOVA|||||5.49|-4.57|0.8561
91638999|NCT01333501|183169471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|2.53||0.8858|TWO_SIDED|95.0|-4.67|5.4|||ANCOVA|||||5.40|-4.67|0.8858
91639000|NCT01333501|183169472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.47||0.7119|TWO_SIDED|95.0|-0.76|1.11|||ANCOVA|||||1.11|-0.76|0.7119
91639001|NCT01333501|183169473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.42||0.9496|TWO_SIDED|95.0|-0.86|0.81|||ANCOVA|||||0.81|-0.86|0.9496
91715926|NCT04539964|183322614|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|-17.6||||0.1643|TWO_SIDED|95.0|-51.1|16.0|||Cochran-Mantel-Haenszel|||||16.0|-51.1|0.1643
91639002|NCT01333501|183169474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.18||0.8944|TWO_SIDED|95.0|-2.18|2.5|||ANCOVA|||||2.50|-2.18|0.8944
91639003|NCT01333501|183169475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.59||0.6757|TWO_SIDED|95.0|-1.42|0.92|||ANCOVA|||||0.92|-1.42|0.6757
91639004|NCT01333501|183169476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|2.34||0.3585|TWO_SIDED|95.0|-6.82|2.5|||ANCOVA|||||2.50|-6.82|0.3585
91639005|NCT01333501|183169477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.24|STANDARD_ERROR_OF_MEAN|3.69||0.161|TWO_SIDED|95.0|-12.62|2.14|||ANCOVA|||||2.14|-12.62|0.1610
91639006|NCT03485976|183169503|OTHER||||||<|0.001||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||||||<0.001
91639007|NCT03485976|183169504|OTHER|||||||0.004||||||The threshold for significance was p=0.05|t-test, 2 sided|||||||0.004
91715927|NCT04539964|183322615|SUPERIORITY|The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate.|Risk Difference (RD)|-2.4||||0.415|TWO_SIDED|95.0|-24.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|-24.1|0.415
91639008|NCT03485976|183169505|OTHER|||||||0.001||||||Threshold for significance was p=0.05|t-test, 2 sided|||||||0.001
91639009|NCT01680835|183169575|OTHER|Freedom from primary safety composite event at 36 months compared to a performance goal of 35%|Kaplan Meier|0.771|||<|0.001|ONE_SIDED|97.5|0.678||||Log Rank||||||0.678|<0.001
91639010|NCT01680835|183169576|OTHER|No hypothesis Testing for this endpoint.|Kaplan Meier|1.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Stent Fracture at 1 Year||||
91639011|NCT01680835|183169576|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.989|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Stent Fracture at 2 Years||||
91639012|NCT01680835|183169576|OTHER|No hypothesis testing was done for this endpoint|Kaplan Meier|0.965|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|||||||||Stent Fracture at 3 Years||||
91639013|NCT01680835|183169577|OTHER|No hypothesis testing was done at this endpoint|Kaplan Meier|0.86|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year||||
91639014|NCT01680835|183169577|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.782|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years||||
91639015|NCT01680835|183169578|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.99|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Estimate from freedom from major amputation through 3 years.||||
91639016|NCT01680835|183169579|OTHER||Kaplan Meier|0.781|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from clinically-driven TLR through 3 Years||||
91639017|NCT03026556|183169586|OTHER||Hazard Ratio (HR)|0.766||||0.0844|TWO_SIDED|95.0|0.566|1.037|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.037|0.566|0.0844
91639018|NCT03026556|183169586|OTHER||Hazard Ratio (HR)|1.255||||0.4892|TWO_SIDED|95.0|0.659|2.39|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.390|0.659|0.4892
91639019|NCT03026556|183169587|OTHER||Hazard Ratio (HR)|0.82||||0.0182|TWO_SIDED|95.0|0.696|0.967|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.967|0.696|0.0182
91639020|NCT03026556|183169587|OTHER||Hazard Ratio (HR)|1.374||||0.0702|TWO_SIDED|95.0|0.974|1.939|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.939|0.974|0.0702
91639021|NCT03026556|183169588|OTHER||Hazard Ratio (HR)|0.923||||0.6307|TWO_SIDED|95.0|0.667|1.278|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.278|0.667|0.6307
91485565|NCT00406354|182844254|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the nine-week study treatment period.|Fisher Exact|||||||0.101
91692152|NCT01262872|183279149|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.3|||||TWO_SIDED|95.0|-18.0|25.7||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-18.0|
91639022|NCT03026556|183169588|OTHER||Hazard Ratio (HR)|1.054||||0.8777|TWO_SIDED|95.0|0.54|2.055|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.055|0.540|0.8777
91639023|NCT03026556|183169589|OTHER||Hazard Ratio (HR)|0.223||||0.0023|TWO_SIDED|95.0|0.085|0.585|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.585|0.085|0.0023
91639024|NCT03026556|183169590|OTHER||Hazard Ratio (HR)|0.654||||0.0406|TWO_SIDED|95.0|0.435|0.982|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.982|0.435|0.0406
91639025|NCT03026556|183169590|OTHER||Hazard Ratio (HR)|1.11||||0.8124|TWO_SIDED|95.0|0.469|2.63|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.630|0.469|0.8124
91639026|NCT03026556|183169591|OTHER||Hazard Ratio (HR)|0.856||||0.0901|TWO_SIDED|95.0|0.716|1.025|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.025|0.716|0.0901
91639027|NCT03026556|183169591|OTHER||Hazard Ratio (HR)|1.431||||0.0616|TWO_SIDED|95.0|0.983|2.083|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.083|0.983|0.0616
91639028|NCT03026556|183169592|OTHER||Hazard Ratio (HR)|0.887||||0.2073|TWO_SIDED|95.0|0.736|1.069|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.069|0.736|0.2073
91639029|NCT03026556|183169592|OTHER||Hazard Ratio (HR)|1.504||||0.0417|TWO_SIDED|95.0|1.015|2.228|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.228|1.015|0.0417
91639030|NCT03026556|183169594|OTHER||Hazard Ratio (HR)|0.709||||0.2663|TWO_SIDED|95.0|0.387|1.299|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.299|0.387|0.2663
91639031|NCT03026556|183169594|OTHER||Hazard Ratio (HR)|0.864||||0.8112|TWO_SIDED|95.0|0.261|2.863|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.863|0.261|0.8112
91639032|NCT03026556|183169595|OTHER||Hazard Ratio (HR)|0.766||||0.1227|TWO_SIDED|95.0|0.546|1.075|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.075|0.546|0.1227
91639033|NCT03026556|183169595|OTHER||Hazard Ratio (HR)|1.138||||0.7115|TWO_SIDED|95.0|0.573|2.26|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.260|0.573|0.7115
91639034|NCT03026556|183169596|OTHER||Hazard Ratio (HR)|0.923||||0.4727|TWO_SIDED|95.0|0.741|1.149|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.149|0.741|0.4727
91485566|NCT02080637|182844259|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.5||0.01|TWO_SIDED||||||Paired t-test|||Baseline versus 2 hours post-ambrisentan||||0.01
91639035|NCT03026556|183169596|OTHER||Hazard Ratio (HR)|1.721||||0.0275|TWO_SIDED|95.0|1.062|2.79|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.790|1.062|0.0275
91639036|NCT03026556|183169597|OTHER||Hazard Ratio (HR)|1.346||||0.2309|TWO_SIDED|95.0|0.828|2.189|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.189|0.828|0.2309
91639037|NCT03026556|183169597|OTHER||Hazard Ratio (HR)|1.557||||0.3333|TWO_SIDED|95.0|0.635|3.821|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||3.821|0.635|0.3333
91639038|NCT03026556|183169598|OTHER||Hazard Ratio (HR)|1.008||||0.9359|TWO_SIDED|95.0|0.829|1.226|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.226|0.829|0.9359
91485567|NCT02080637|182844260|OTHER||Slope|-27.0||||0.94|TWO_SIDED|95.0|-775.0|723.0|||Regression, Linear|||||723|-775|0.94
91485568|NCT02080637|182844261|OTHER||Slope|1.2||||0.61|TWO_SIDED|95.0|-3.9|6.3|||Regression, Linear|||||6.3|-3.9|0.61
91639039|NCT03026556|183169598|OTHER||Hazard Ratio (HR)|1.024||||0.8947|TWO_SIDED|95.0|0.716|1.465|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.465|0.716|0.8947
91639040|NCT00387621|183169602|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|With Bonferroni correction for multiple comparisons||||||<0.05
91639041|NCT00387621|183169603|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||rank-sum test|Rank-sum test was used due to non-normality of data with Bonferroni correction for multiple comparisons||||||<0.05
91639042|NCT01190839|183169612|SUPERIORITY_OR_OTHER|||||||0.097||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.097
91639043|NCT01190839|183169613|SUPERIORITY_OR_OTHER||||||<|0.001||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||<0.001
91485569|NCT01483807|182844262|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.254|ONE_SIDED||||||t-test, 1 sided|||Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.||||.254
91485570|NCT01483807|182844263|SUPERIORITY||Mean Difference (Final Values)|8.25||||0.043|ONE_SIDED||||||t-test, 1 sided|||On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.||||.043
91485571|NCT01483807|182844264|SUPERIORITY|||||||0.396|||||||t-test, 1 sided|||Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.||||.396
91672677|NCT00440466|183240226|NON_INFERIORITY_OR_EQUIVALENCE|Under the same assumptions in the sample size calculation for the QW and the Q2W, 100 subjects would be needed for the Q4W. However, because Study EPO-AKD-3001 and the current study both included QW and Q2W groups, the sample size would add up to 200 for each group if combined, the sample size in the Q4W group in the current study was increased to 200 subjects in order to enroll a comparable and sufficiently large number of subjects in each of the 3 extended dosing groups across the 2 studies.|Difference of Least Squares Means|-0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.249|0.063|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-4-weeks (Q4W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.063|-0.249|
91672678|NCT00440466|183240228|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|0.1|21.7|||95% Confidence Interval|||||21.7|0.1|
91672679|NCT00440466|183240228|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-9.1|11.2|||95% of Confidence Interval|||||11.2|-9.1|
91672680|NCT00440466|183240229|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.13|||||TWO_SIDED|95.0|-0.113|0.372|||ANOVA|||||0.372|-0.113|
91672681|NCT00440466|183240229|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.098|0.32|||ANOVA|||||0.320|-0.098|
91672682|NCT00440466|183240230|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.2|||||TWO_SIDED|95.0|-2.0|18.3|||95% of Confidence Interval|||||18.3|-2.0|
91672683|NCT00440466|183240230|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.3||||||95.0|1.5|19.2|||95% of Confidence Interval|||||19.2|1.5|
91672684|NCT00440466|183240231|SUPERIORITY_OR_OTHER||Difference in percentage of participants|5.7|||||TWO_SIDED|95.0|-7.7|19.1|||95% of Confidence Interval|||||19.1|-7.7|
91485572|NCT01483807|182844265|SUPERIORITY|||||||0.212|||||||t-test, 1 sided|||Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.||||.212
91526418|NCT04078035|182927998|SUPERIORITY||Slope|0.00075|STANDARD_ERROR_OF_MEAN|0.00012||0.51|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.51
91672685|NCT00440466|183240231|SUPERIORITY_OR_OTHER||Difference in percentage of participants|9.1|||||TWO_SIDED|95.0|-2.5|20.6|||95% of Confidence Interval|||||20.6|-2.5|
91672686|NCT00440466|183240232|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-15.8|9.5|||95% of Confidence Interval|||||9.5|-15.8|
91672687|NCT00440466|183240232|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.0|||||TWO_SIDED|95.0|-13.9|8.0|||95% of Confidence Interval|||||8.0|-13.9|
91672688|NCT00440466|183240233|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.08||||||95.0|-0.367|0.208|||ANOVA|||||0.208|-0.367|
91672689|NCT00440466|183240233|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.206|0.289|||ANOVA|||||0.289|-0.206|
91672690|NCT02997657|183240235|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
91672691|NCT02997657|183240236|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
91672692|NCT02997657|183240237|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
91672693|NCT02997657|183240238|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
91672694|NCT02997657|183240239|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91672695|NCT02997657|183240240|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
91672696|NCT02997657|183240241|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
91672697|NCT03756883|183240248|EQUIVALENCE|The 90% Confidence Interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|101.8|||||TWO_SIDED|90.0|92.68|111.94||||||||111.94|92.68|
91672698|NCT03756883|183240249|EQUIVALENCE|The 90% confidence interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|98.09|||||TWO_SIDED|90.0|87.1|110.61||||||||110.61|87.10|
91672699|NCT03756883|183240250|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of the test product over the placebo.||||<0.0001
91672700|NCT03756883|183240250|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of Reference to placebo.||||<0.0001
91672701|NCT03756883|183240251|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of test over placebo.||||<0.0001
91672702|NCT03756883|183240251|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of reference to placebo.||||<0.0001
91672703|NCT00754442|183240255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED|95.0||||see above|t-test, 2 sided|95%||The null hypothesis is that there is no statistical difference between patients and controls at baseline||||0.1
91672704|NCT00754442|183240255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 4 hours||||0.002
91672705|NCT00754442|183240255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs||||0.003
91672706|NCT03005067|183240257|OTHER||Mean Difference (Net)|0.137||||0.516|TWO_SIDED|95.0|-0.279|0.553||P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.|ANCOVA||Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.|||0.553|-0.279|0.516
91526419|NCT04078035|182927999|SUPERIORITY||Slope|-0.0053|STANDARD_ERROR_OF_MEAN|0.0026||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
91639044|NCT01190839|183169614|SUPERIORITY_OR_OTHER|||||||0.098||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.098
91639045|NCT01153971|183169623|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91639046|NCT01789476|183169641|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.05
91639047|NCT01789476|183169642|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
91639048|NCT01789476|183169643|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
91639049|NCT01238861|183169644|SUPERIORITY_OR_OTHER||Rate Ratio|1.09||||0.781|TWO_SIDED|80.0|0.74|1.59|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||1.59|0.74|0.781
91639050|NCT01238861|183169644|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.173|TWO_SIDED|80.0|0.42|0.97|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.97|0.42|0.173
91639051|NCT01238861|183169644|SUPERIORITY_OR_OTHER||Rate ratio|0.59||||0.096|TWO_SIDED|80.0|0.4|0.89|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.89|0.40|0.096
91639052|NCT01238861|183169649|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANCOVA|P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.125
91639053|NCT01238861|183169649|SUPERIORITY_OR_OTHER|||||||0.074|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.074
91639054|NCT01238861|183169649|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.057
91639055|NCT01238861|183169649|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.010
91639056|NCT01238861|183169651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.131|TWO_SIDED|80.0|-0.336|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.336|0.131
91639057|NCT01238861|183169651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.173||||0.126|TWO_SIDED|80.0|-0.317|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.317|0.126
91639058|NCT01238861|183169651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.097|TWO_SIDED|80.0|-0.247|-0.032|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.032|-0.247|0.097
91639059|NCT01238861|183169652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.642|TWO_SIDED|80.0|-0.654|0.306|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.306|-0.654|0.642
91639060|NCT01238861|183169652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.824|TWO_SIDED|80.0|-0.533|0.756|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.756|-0.533|0.824
91639061|NCT01238861|183169652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.91|TWO_SIDED|80.0|-0.297|0.355|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.355|-0.297|0.910
91639062|NCT01238861|183169652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.992|TWO_SIDED|80.0|-0.602|0.593|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.593|-0.602|0.992
91639063|NCT01238861|183169652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337||||0.624|TWO_SIDED|80.0|-0.548|1.222|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||1.222|-0.548|0.624
91639064|NCT01238861|183169652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.645|TWO_SIDED|80.0|-0.267|0.567|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.567|-0.267|0.645
91639065|NCT01238861|183169653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.014|TWO_SIDED|80.0|0.076|0.237|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.237|0.076|0.014
91639066|NCT01238861|183169653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184||||0.004|TWO_SIDED|80.0|0.102|0.266|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.266|0.102|0.004
91639067|NCT01238861|183169653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||0.026|TWO_SIDED|80.0|0.039|0.143|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.143|0.039|0.026
91639068|NCT01238861|183169654|SUPERIORITY_OR_OTHER|||||||0.384|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.384
91639069|NCT01238861|183169654|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.092
91485573|NCT03438383|182844266|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.88||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.88
91639070|NCT01238861|183169654|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.134
91639071|NCT01238861|183169654|SUPERIORITY_OR_OTHER|||||||0.129|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.129
91639072|NCT01238861|183169656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404||||0.069|TWO_SIDED|80.0|0.121|0.687|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.687|0.121|0.069
91672707|NCT03233958|183240261|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.24|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91639073|NCT01238861|183169656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462||||0.049|TWO_SIDED|80.0|0.163|0.761|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.761|0.163|0.049
91672708|NCT03233958|183240262|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|5.55|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91672709|NCT03233958|183240263|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.54||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
91672710|NCT03233958|183240264|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.18||||0.076|TWO_SIDED||||||ANOVA|||||||0.076
91672711|NCT03233958|183240265|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.51||||0.147|TWO_SIDED||||||ANOVA|||||||0.147
91639074|NCT01238861|183169656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.168|TWO_SIDED|80.0|0.017|0.459|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.459|0.017|0.168
91639075|NCT01238861|183169657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|80.0|-0.058|0.019|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.019|-0.058|0.510
91672712|NCT03233958|183240266|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.07||||0.197|TWO_SIDED||||||ANOVA|||||||0.197
91672713|NCT03233958|183240267|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91672714|NCT02310763|183240364|SUPERIORITY||Mean Difference (Net)|1.293|STANDARD_ERROR_OF_MEAN|1.022||0.2088|TWO_SIDED|95.0|-0.7343|3.32||The significance level is 0.05.|ANCOVA||Least square mean difference was calculated by placebo minus domagrozumab.|||3.3200|-0.7343|0.2088
91672715|NCT02310763|183240368|SUPERIORITY||Mean Difference (Net)|-0.0845||||0.9191|TWO_SIDED|95.0|-1.7354|1.5663||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.5663|-1.7354|0.9191
91672716|NCT02310763|183240368|SUPERIORITY||Mean Difference (Net)|0.5837||||0.7642|TWO_SIDED|95.0|-3.2978|4.4652||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4652|-3.2978|0.7642
91672717|NCT02310763|183240368|SUPERIORITY||Mean Difference (Net)|0.2712||||0.9423|TWO_SIDED|95.0|-7.3799|7.9223||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.9223|-7.3799|0.9423
91672718|NCT02310763|183240369|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.0693|0.0693||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||0.0693|-0.0693|0.9993
91672719|NCT02310763|183240369|SUPERIORITY||Mean Difference (Net)|-0.0259||||0.5464|TWO_SIDED|95.0|-0.1107|0.0589||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||0.0589|-0.1107|0.5464
91639076|NCT01238861|183169657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.113|TWO_SIDED|80.0|0.008|0.074|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.074|0.008|0.113
91672720|NCT02310763|183240369|SUPERIORITY||Mean Difference (Net)|-0.042||||0.3041|TWO_SIDED|95.0|-0.1227|0.0386||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||0.0386|-0.1227|0.3041
91672721|NCT02310763|183240370|SUPERIORITY||Mean Difference (Net)|0.8||||0.3522|TWO_SIDED|95.0|-0.9|2.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||2.5|-0.9|0.3522
91672722|NCT02310763|183240370|SUPERIORITY||Mean Difference (Net)|2.5||||0.0061|TWO_SIDED|95.0|0.7|4.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.2|0.7|0.0061
91639077|NCT01238861|183169657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.599|TWO_SIDED|80.0|-0.016|0.038|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.038|-0.016|0.599
91639078|NCT01238861|183169658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373||||0.871|TWO_SIDED|80.0|-3.333|2.586|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||2.586|-3.333|0.871
91639079|NCT01238861|183169658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.857||||0.227|TWO_SIDED|80.0|-0.175|5.889|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||5.889|-0.175|0.227
91639080|NCT01238861|183169658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.139||||0.503|TWO_SIDED|80.0|-1.041|3.319|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||3.319|-1.041|0.503
91485574|NCT03438383|182844266|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.23||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.23
91526420|NCT04078035|182928000|SUPERIORITY||Slope|0.0018|STANDARD_ERROR_OF_MEAN|0.0027||0.49|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.49
91672723|NCT02310763|183240370|SUPERIORITY|Week 49|Mean Difference (Net)|1.6||||0.1268|TWO_SIDED|95.0|-0.5|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|||3.8|-0.5|0.1268
91672724|NCT02310763|183240371|SUPERIORITY||Mean Difference (Net)|-0.4||||0.7337|TWO_SIDED|95.0|-2.9|2.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 17||2.1|-2.9|0.7337
91672725|NCT02310763|183240371|SUPERIORITY||Mean Difference (Net)|0.2||||0.8893|TWO_SIDED|95.0|-2.4|2.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 33||2.7|-2.4|0.8893
91672726|NCT02310763|183240371|SUPERIORITY||Mean Difference (Net)|-1.5||||0.2939|TWO_SIDED|95.0|-4.3|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 49||1.3|-4.3|0.2939
91672727|NCT02310763|183240371|SUPERIORITY||Mean Difference (Net)|0.8||||0.5995|TWO_SIDED|95.0|-2.1|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 17||3.6|-2.1|0.5995
91672728|NCT02310763|183240371|SUPERIORITY||Mean Difference (Net)|2.9||||0.0385|TWO_SIDED|95.0|0.2|5.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 33||5.6|0.2|0.0385
91672729|NCT02310763|183240371|SUPERIORITY||Mean Difference (Net)|0.0||||0.9927|TWO_SIDED|95.0|-3.3|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 49||3.2|-3.3|0.9927
91672730|NCT02310763|183240372|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6049|TWO_SIDED|95.0|-1.7|1.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.0|-1.7|0.6049
91672731|NCT02310763|183240372|SUPERIORITY||Mean Difference (Net)|1.7||||0.2065|TWO_SIDED|95.0|-1.0|4.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4|-1.0|0.2065
91672732|NCT02310763|183240372|SUPERIORITY||Mean Difference (Net)|0.0||||0.9391|TWO_SIDED|95.0|-1.3|1.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||1.2|-1.3|0.9391
91672733|NCT02310763|183240373|SUPERIORITY||Mean Difference (Net)|1.8||||0.8499|TWO_SIDED|95.0|-16.7|20.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||20.3|-16.7|0.8499
91672734|NCT02310763|183240373|SUPERIORITY||Mean Difference (Net)|8.9||||0.4008|TWO_SIDED|95.0|-12.0|29.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||29.8|-12.0|0.4008
91672735|NCT02310763|183240373|SUPERIORITY||Mean Difference (Net)|-1.5||||0.916|TWO_SIDED|95.0|-30.0|27.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||27.0|-30.0|0.9160
91672736|NCT02310763|183240374|SUPERIORITY||Mean Difference (Net)|0.115||||0.5726|TWO_SIDED|95.0|-0.287|0.517||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 17||0.517|-0.287|0.5726
91672737|NCT02310763|183240374|SUPERIORITY||Mean Difference (Net)|-0.163||||0.4334|TWO_SIDED|95.0|-0.574|0.248||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 33||0.248|-0.574|0.4334
91672738|NCT02310763|183240374|SUPERIORITY||Mean Difference (Net)|-0.126||||0.5767|TWO_SIDED|95.0|-0.573|0.321||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 49||0.321|-0.573|0.5767
91672739|NCT02310763|183240374|SUPERIORITY||Mean Difference (Net)|-0.022||||0.9274|TWO_SIDED|95.0|-0.489|0.446||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 17||0.446|-0.489|0.9274
91672740|NCT02310763|183240374|SUPERIORITY||Mean Difference (Net)|-0.439||||0.0469|TWO_SIDED|95.0|-0.872|-0.006||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 33||-0.006|-0.872|0.0469
91672741|NCT02310763|183240374|SUPERIORITY||Mean Difference (Net)|-0.166||||0.4362|TWO_SIDED|95.0|-0.587|0.255||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 49||0.255|-0.587|0.4362
91672742|NCT02310763|183240375|SUPERIORITY||Mean Difference (Net)|-0.156||||0.5557|TWO_SIDED|95.0|-0.679|0.367||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 17||0.367|-0.679|0.5557
91672743|NCT02310763|183240375|SUPERIORITY||Mean Difference (Net)|-0.303||||0.2669|TWO_SIDED|95.0|-0.841|0.235||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 33||0.235|-0.841|0.2669
91672744|NCT02310763|183240375|SUPERIORITY||Mean Difference (Net)|-0.161||||0.4665|TWO_SIDED|95.0|-0.598|0.276||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 49||0.276|-0.598|0.4665
91672745|NCT02310763|183240375|SUPERIORITY||Mean Difference (Net)|-0.083||||0.7335|TWO_SIDED|95.0|-0.564|0.399||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 17||0.399|-0.564|0.7335
91672746|NCT02310763|183240375|SUPERIORITY||Mean Difference (Net)|-0.361||||0.1695|TWO_SIDED|95.0|-0.877|0.156||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 33||0.156|-0.877|0.1695
91639081|NCT01238861|183169659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.907||||0.55|TWO_SIDED|80.0|-4.483|12.297|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||12.297|-4.483|0.550
91639082|NCT01238861|183169659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.659||||0.215|TWO_SIDED|80.0|-0.262|15.579|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||15.579|-0.262|0.215
91639083|NCT01238861|183169659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54||||0.413|TWO_SIDED|80.0|-2.006|9.086|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||9.086|-2.006|0.413
91639084|NCT01238861|183169660|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.896
91639085|NCT01238861|183169660|SUPERIORITY_OR_OTHER|||||||0.944|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.944
91639086|NCT01238861|183169660|SUPERIORITY_OR_OTHER|||||||0.667|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.667
91639087|NCT01342445|183169676|SUPERIORITY_OR_OTHER_LEGACY||Partial eta squared|0.34|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 10.9~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<0.001
91639088|NCT01342445|183169677|SUPERIORITY_OR_OTHER_LEGACY||partial eta squared|0.28|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 8.14~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<.001
91639089|NCT02652793|183169684|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.0239|TWO_SIDED|95.0|0.001|0.019||Statistical test applied to lumbar spine BMD only. P-value reflects within-group change from baseline to Week 48.|Regression, Linear|Per-protocol analysis; missing data excluded|Represents mean change in lumbar spine BMD from baseline to Week 48.|Single-arm study; no comparator group||0.019|0.001|0.0239
91639090|NCT02652793|183169684|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.013|STANDARD_DEVIATION|0.03||0.0046|TWO_SIDED|95.0|0.004|0.023||Left hip|Regression, Linear|Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48.|Represents mean change in left hip BMD from baseline to Week 48|Single-arm study; no comparator group||0.023|0.004|0.0046
91639091|NCT06045026|183169720|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91672747|NCT02310763|183240375|SUPERIORITY||Mean Difference (Net)|-0.189||||0.3783|TWO_SIDED|95.0|-0.612|0.234||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 49||0.234|-0.612|0.3783
91672748|NCT02310763|183240376|SUPERIORITY||Mean Difference (Net)|-0.586||||0.1078|TWO_SIDED|95.0|-1.303|0.13||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 17||0.130|-1.303|0.1078
91526421|NCT04078035|182928001|SUPERIORITY||Slope|0.013|STANDARD_ERROR_OF_MEAN|0.0044||0.002|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.002
91639092|NCT06045026|183169720|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639093|NCT06045026|183169720|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639094|NCT06045026|183169720|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91672749|NCT02310763|183240376|SUPERIORITY||Mean Difference (Net)|0.046||||0.8967|TWO_SIDED|95.0|-0.654|0.746||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 33||0.746|-0.654|0.8967
91672750|NCT02310763|183240376|SUPERIORITY||Mean Difference (Net)|-0.378||||0.3196|TWO_SIDED|95.0|-1.128|0.371||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 49||0.371|-1.128|0.3196
91672751|NCT02310763|183240376|SUPERIORITY||Mean Difference (Net)|-0.689||||0.0526|TWO_SIDED|95.0|-1.386|0.008||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 17||0.008|-1.386|0.0526
91639095|NCT06045026|183169720|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639096|NCT06045026|183169720|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639097|NCT06045026|183169721|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639098|NCT06045026|183169721|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639099|NCT06045026|183169721|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91526422|NCT02100722|182928013|NON_INFERIORITY|Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio.|Hazard Ratio (HR)|1.5||||0.35|TWO_SIDED|95.0|1.1|2.2|||Regression, Cox|||A sample of 712 patients per group (1424 for the entire trial) would be required in order to achieve 90% power to claim noninferiority||2.2|1.1|0.35
91672752|NCT02310763|183240376|SUPERIORITY||Mean Difference (Net)|-0.336||||0.3739|TWO_SIDED|95.0|-1.082|0.41||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 33||0.410|-1.082|0.3739
91672753|NCT02310763|183240376|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4019|TWO_SIDED|95.0|-1.079|0.436||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 49||0.436|-1.079|0.4019
91672754|NCT02310763|183240377|SUPERIORITY||Mean Difference (Net)|-0.107||||0.7676|TWO_SIDED|95.0|-0.825|0.61||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 17||0.610|-0.825|0.7676
91526423|NCT02100722|182928016|OTHER||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|0.7|4.3||||||||4.3|0.7|
91639100|NCT06045026|183169721|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639101|NCT06045026|183169721|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639102|NCT06045026|183169721|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639103|NCT06045026|183169722|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639104|NCT06045026|183169722|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639105|NCT06045026|183169722|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639106|NCT06045026|183169722|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639107|NCT06045026|183169722|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639108|NCT06045026|183169722|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639109|NCT06045026|183169723|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639110|NCT06045026|183169723|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639111|NCT06045026|183169723|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639112|NCT06045026|183169723|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639113|NCT06045026|183169723|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639114|NCT06045026|183169723|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639115|NCT06045026|183169724|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639116|NCT06045026|183169724|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639117|NCT06045026|183169724|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639118|NCT06045026|183169724|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639119|NCT06045026|183169724|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639120|NCT06045026|183169724|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639121|NCT06045026|183169725|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639122|NCT06045026|183169725|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639123|NCT06045026|183169725|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639124|NCT06045026|183169725|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639125|NCT06045026|183169725|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639126|NCT06045026|183169725|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639127|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 4||||<0.0001
91639128|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 8||||<0.0001
91639129|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 12||||<0.0001
91639130|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 16||||<0.0001
91639131|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 20||||<0.0001
91639132|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 24||||<0.0001
91639133|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4||||<0.0001
91639134|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8||||<0.0001
91672755|NCT02310763|183240377|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4127|TWO_SIDED|95.0|-1.098|0.454||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 33||0.454|-1.098|0.4127
91672756|NCT02310763|183240377|SUPERIORITY||Mean Difference (Net)|0.113||||0.7815|TWO_SIDED|95.0|-0.693|0.919||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 49||0.919|-0.693|0.7815
91672757|NCT02310763|183240377|SUPERIORITY||Mean Difference (Net)|-0.236||||0.4975|TWO_SIDED|95.0|-0.924|0.451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 17||0.451|-0.924|0.4975
91672758|NCT02310763|183240377|SUPERIORITY||Mean Difference (Net)|-0.467||||0.2646|TWO_SIDED|95.0|-1.294|0.359||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 33||0.359|-1.294|0.2646
91672759|NCT02310763|183240377|SUPERIORITY||Mean Difference (Net)|-0.149||||0.732|TWO_SIDED|95.0|-1.008|0.71||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 49||0.710|-1.008|0.7320
91672760|NCT02310763|183240378|SUPERIORITY||Mean Difference (Net)|-0.044||||0.8569|TWO_SIDED|95.0|-0.525|0.437||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 17||0.437|-0.525|0.8569
91672761|NCT02310763|183240378|SUPERIORITY||Mean Difference (Net)|-0.154||||0.5495|TWO_SIDED|95.0|-0.663|0.355||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 33||0.355|-0.663|0.5495
91672762|NCT02310763|183240378|SUPERIORITY||Mean Difference (Net)|-0.023||||0.934|TWO_SIDED|95.0|-0.566|0.521||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 49||0.521|-0.566|0.9340
91672763|NCT02310763|183240378|SUPERIORITY||Mean Difference (Net)|-0.236||||0.3279|TWO_SIDED|95.0|-0.711|0.239||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 17||0.239|-0.711|0.3279
91672764|NCT02310763|183240378|SUPERIORITY||Mean Difference (Net)|-0.757||||0.0086|TWO_SIDED|95.0|-1.318|-0.196||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 33||-0.196|-1.318|0.0086
91672765|NCT02310763|183240378|SUPERIORITY||Mean Difference (Net)|-0.439||||0.2328|TWO_SIDED|95.0|-1.165|0.286||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 49||0.286|-1.165|0.2328
91672766|NCT02310763|183240379|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.211||||0.8908|TWO_SIDED|95.0|-2.8353|3.2573|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||3.2573|-2.8353|0.8908
91485575|NCT03438383|182844266|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 hours post-operatively||||0.008
91672767|NCT02310763|183240380|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.819||||0.4748|TWO_SIDED|95.0|-1.4514|3.0895|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||3.0895|-1.4514|0.4748
91672768|NCT02310763|183240381|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0097||||0.807|TWO_SIDED|95.0|-0.0692|0.0887|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0.0887|-0.0692|0.8070
91672769|NCT02310763|183240382|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0506||||0.3643|TWO_SIDED|95.0|-0.0594|0.1607|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||0.1607|-0.0594|0.3643
91672770|NCT02310763|183240383|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-2.9||||0.0483|TWO_SIDED|95.0|-5.7|0.0|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0|-5.7|0.0483
91672771|NCT02310763|183240384|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-3.9||||0.0146|TWO_SIDED|95.0|-7.0|-0.8|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-0.8|-7.0|0.0146
91672772|NCT02310763|183240385|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-31.6||||0.1669|TWO_SIDED|95.0|-76.9|13.6|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||13.6|-76.9|0.1669
91672773|NCT02310763|183240386|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-66.3||||0.0267|TWO_SIDED|95.0|-124.5|-8.1|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-8.1|-124.5|0.0267
91672774|NCT02310763|183240387|SUPERIORITY||Mean Difference (Net)|-0.0692||||0.7033|TWO_SIDED|95.0|-0.4345|0.2961||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.2961|-0.4345|0.7033
91672775|NCT02310763|183240387|SUPERIORITY||Mean Difference (Net)|0.2114||||0.6893|TWO_SIDED|95.0|-0.8472|1.27||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.27|-0.8472|0.6893
91672776|NCT02310763|183240387|SUPERIORITY||Mean Difference (Net)|-2.6439||||0.6469|TWO_SIDED|95.0|-14.4292|9.1414||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||9.1414|-14.4292|0.6469
91672777|NCT02310763|183240388|SUPERIORITY||Mean Difference (Net)|-0.3289||||0.1353|TWO_SIDED|95.0|-0.7649|0.1072||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1072|-0.7649|0.1353
91672778|NCT02310763|183240388|SUPERIORITY||Mean Difference (Net)|0.3457||||0.7648|TWO_SIDED|95.0|-1.9614|2.6528||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||2.6528|-1.9614|0.7648
91715928|NCT01674725|183322616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.|Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|95.9|
91722539|NCT02629159|183337903|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.15|||<|0.001|TWO_SIDED|95.0|3.13|5.16||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate|Treatment Difference = Upadacitinib - Placebo|||5.16|3.13|<0.001
91526424|NCT02100722|182928017|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.5|||||Hazard ratio for overall number of participants experiencing MI.|||2.5|0.9|
91639135|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12||||<0.0001
91639136|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16||||<0.0001
91639137|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20||||<0.0001
91639138|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24||||<0.0001
91639139|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4||||<0.0001
91639140|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8||||<0.0001
91639141|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12||||<0.0001
91639142|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16||||<0.0001
91639143|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20||||<0.0001
91639144|NCT06045026|183169726|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24||||<0.0001
91639145|NCT06045026|183169727|SUPERIORITY|||||||0.01|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||0.0100
91526425|NCT02100722|182928018|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.4||||||||2.4|0.3|
91639146|NCT06045026|183169727|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639147|NCT06045026|183169727|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639148|NCT06045026|183169727|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639149|NCT06045026|183169727|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639150|NCT06045026|183169727|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639151|NCT06045026|183169728|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639152|NCT06045026|183169728|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639153|NCT06045026|183169728|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639154|NCT06045026|183169728|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639155|NCT06045026|183169728|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639156|NCT06045026|183169728|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639157|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 1||||<0.0001
91639158|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 2||||<0.0001
91639159|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
91639160|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
91639161|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
91639162|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
91639163|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
91639164|NCT06045026|183169730|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
91639165|NCT04550234|183169733|OTHER||Geometric mean ratio|57.73|||||TWO_SIDED|90.0|47.07|70.81||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||70.81|47.07|
91485576|NCT03438383|182844266|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.001||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.001
91639166|NCT04550234|183169733|OTHER||Geometric mean ratio|145.55|||||TWO_SIDED|90.0|118.66|178.52||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||178.52|118.66|
91639167|NCT04550234|183169733|OTHER||Geometric mean ratio|52.07|||||TWO_SIDED|90.0|42.46|63.87||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||63.87|42.46|
91639168|NCT04550234|183169733|OTHER||Geometric mean ratio|101.16|||||TWO_SIDED|90.0|82.48|124.08||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.08|82.48|
91639169|NCT04550234|183169733|OTHER||Geometric mean ratio|73.34|||||TWO_SIDED|90.0|61.81|87.03||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||87.03|61.81|
91639170|NCT04550234|183169733|OTHER||Geometric mean ratio|66.33|||||TWO_SIDED|90.0|55.9|78.72||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||78.72|55.90|
91639171|NCT04550234|183169733|OTHER||Geometric mean ratio|106.58|||||TWO_SIDED|90.0|89.81|126.47||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.47|89.81|
91639172|NCT04550234|183169733|OTHER||Geometric mean ratio|86.86|||||TWO_SIDED|90.0|83.15|90.74||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||90.74|83.15|
91639173|NCT04550234|183169733|OTHER||Geometric mean ratio|92.3|||||TWO_SIDED|90.0|88.35|96.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||96.42|88.35|
91639174|NCT04550234|183169733|OTHER||Geometric mean ratio|89.54|||||TWO_SIDED|90.0|85.71|93.54||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.54|85.71|
91639175|NCT04550234|183169734|OTHER||Geometric mean ratio|102.49|||||TWO_SIDED|90.0|89.12|117.86||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||117.86|89.12|
91639176|NCT04550234|183169734|OTHER||Geometric mean ratio|144.61|||||TWO_SIDED|90.0|125.75|166.31||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||166.31|125.75|
91639177|NCT04550234|183169734|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.71|88.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.23|66.71|
91639178|NCT04550234|183169734|OTHER||Geometric mean ratio|96.19|||||TWO_SIDED|90.0|83.64|110.62||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.62|83.64|
91639179|NCT04550234|183169734|OTHER||Geometric mean ratio|89.41|||||TWO_SIDED|90.0|83.86|95.34||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||95.34|83.86|
91639180|NCT04550234|183169734|OTHER||Geometric mean ratio|94.16|||||TWO_SIDED|90.0|88.31|100.4||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.40|88.31|
91639181|NCT04550234|183169734|OTHER||Geometric mean ratio|91.7|||||TWO_SIDED|90.0|86.37|97.36||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.36|86.37|
91639182|NCT04550234|183169734|OTHER||Geometric mean ratio|91.23|||||TWO_SIDED|90.0|88.01|94.56||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||94.56|88.01|
91639183|NCT04550234|183169734|OTHER||Geometric mean ratio|99.95|||||TWO_SIDED|90.0|96.43|103.61||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||103.61|96.43|
91639184|NCT04550234|183169734|OTHER||Geometric mean ratio|90.13|||||TWO_SIDED|90.0|86.95|93.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.42|86.95|
91639185|NCT04550234|183169735|OTHER||Geometric mean ratio|102.91|||||TWO_SIDED|90.0|89.04|118.93||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||118.93|89.04|
91639186|NCT04550234|183169735|OTHER||Geometric mean ratio|146.57|||||TWO_SIDED|90.0|126.82|169.4||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||169.40|126.82|
91639187|NCT04550234|183169735|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.38|88.67||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.67|66.38|
91672779|NCT02310763|183240388|SUPERIORITY||Mean Difference (Net)|8.2893||||0.3562|TWO_SIDED|95.0|-9.6409|26.2194||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||26.2194|-9.6409|0.3562
91672780|NCT02310763|183240389|SUPERIORITY||Mean Difference (Net)|-0.5582||||0.1163||95.0|-1.2615|0.1451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1451|-1.2615|0.1163
91672781|NCT02310763|183240389|SUPERIORITY||Mean Difference (Net)|0.0944||||0.9503|TWO_SIDED|95.0|-3.0798|3.2686||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2686|-3.0798|0.9503
91672782|NCT02310763|183240389|SUPERIORITY||Mean Difference (Net)|-11.2881||||0.2947|TWO_SIDED|95.0|-32.8328|10.2566||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||10.2566|-32.8328|0.2947
91639188|NCT04550234|183169735|OTHER||Geometric mean ratio|95.37|||||TWO_SIDED|90.0|82.52|110.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.23|82.52|
91639189|NCT04550234|183169735|OTHER||Geometric mean ratio|82.6|||||TWO_SIDED|90.0|77.38|88.17||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.17|77.38|
91639190|NCT04550234|183169735|OTHER||Geometric mean ratio|87.14|||||TWO_SIDED|90.0|81.63|93.01||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.01|81.63|
91639191|NCT04550234|183169735|OTHER||Geometric mean ratio|91.45|||||TWO_SIDED|90.0|85.67|97.61||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.61|85.67|
91639192|NCT04550234|183169735|OTHER||Geometric mean ratio|90.91|||||TWO_SIDED|90.0|87.98|93.94||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.94|87.98|
91639193|NCT04550234|183169735|OTHER||Geometric mean ratio|99.37|||||TWO_SIDED|90.0|96.17|102.68||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.68|96.17|
91639194|NCT04550234|183169735|OTHER||Geometric mean ratio|89.18|||||TWO_SIDED|90.0|86.3|92.15||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||92.15|86.30|
91672783|NCT02310763|183240390|SUPERIORITY||Mean Difference (Net)|0.0159||||0.8229|TWO_SIDED|95.0|-0.127|0.1588||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1588|-0.1270|0.8229
91672784|NCT02310763|183240390|SUPERIORITY||Mean Difference (Net)|-0.0132||||0.7709|TWO_SIDED|95.0|-0.1036|0.0772||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||0.0772|-0.1036|0.7709
91672785|NCT02310763|183240390|SUPERIORITY||Mean Difference (Net)|0.0889||||0.3746|TWO_SIDED|95.0|-0.1219|0.2996||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.2996|-0.1219|0.3746
91639195|NCT04550234|183169747|OTHER||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.13|124.49||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.49|94.13|
91639196|NCT04550234|183169747|OTHER||Geometric mean ratio|96.57|||||TWO_SIDED|90.0|90.96|102.53||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.53|90.96|
91639197|NCT04550234|183169747|OTHER||Geometric mean ratio|98.75|||||TWO_SIDED|90.0|95.27|102.36||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.36|95.27|
91639198|NCT04550234|183169748|OTHER||Geometric mean ratio|109.27|||||TWO_SIDED|90.0|94.55|126.29||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.29|94.55|
91639199|NCT04550234|183169748|OTHER||Geometric mean ratio|96.47|||||TWO_SIDED|90.0|90.38|102.97||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.97|90.38|
91639200|NCT04550234|183169748|OTHER||Geometric mean ratio|97.48|||||TWO_SIDED|90.0|94.34|100.73||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.73|94.34|
91639201|NCT04550234|183169749|OTHER||Geometric mean ratio|131.28|||||TWO_SIDED|90.0|107.03|161.02||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||161.02|107.03|
91672786|NCT02310763|183240391|SUPERIORITY||Mean Difference (Net)|-0.0934||||0.2294|TWO_SIDED|95.0|-0.2481|0.0613||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0613|-0.2481|0.2294
91672787|NCT02310763|183240391|SUPERIORITY||Mean Difference (Net)|-0.0117||||0.8485|TWO_SIDED|95.0|-0.1339|0.1105||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.1105|-0.1339|0.8485
91672788|NCT02310763|183240391|SUPERIORITY||Mean Difference (Net)|0.0562||||0.6645|TWO_SIDED|95.0|-0.2187|0.3312||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3312|-0.2187|0.6645
91672789|NCT02310763|183240392|SUPERIORITY||Mean Difference (Net)|-0.1013||||0.2101|TWO_SIDED|95.0|-0.2622|0.0597||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0597|-0.2622|0.2101
91526426|NCT02100722|182928019|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.3|||||Hazard ratio for overall number of participants experiencing repeat revascularization.|||2.3|0.9|
91672790|NCT02310763|183240392|SUPERIORITY||Mean Difference (Net)|-0.0359||||0.4603|TWO_SIDED|95.0|-0.1326|0.0608||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.0608|-0.1326|0.4603
91672791|NCT02310763|183240392|SUPERIORITY||Mean Difference (Net)|0.1039||||0.3739|TWO_SIDED|95.0|-0.1386|0.3463||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3463|-0.1386|0.3739
91672792|NCT02310763|183240393|SUPERIORITY||Mean Difference (Net)|-0.3||||0.8925|TWO_SIDED|95.0|-4.5|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.9|-4.5|0.8925
91672793|NCT02310763|183240393|SUPERIORITY||Mean Difference (Net)|1.2||||0.2107|TWO_SIDED|95.0|-0.7|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2|-0.7|0.2107
91672794|NCT02310763|183240393|SUPERIORITY||Mean Difference (Net)|1.3||||0.2298|TWO_SIDED|95.0|-0.9|3.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.5|-0.9|0.2298
91672795|NCT02310763|183240394|SUPERIORITY||Mean Difference (Net)|3.5||||0.0554|TWO_SIDED|95.0|-0.1|7.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||7.1|-0.1|0.0554
91672796|NCT02310763|183240394|SUPERIORITY||Mean Difference (Net)|1.6||||0.2027|TWO_SIDED|95.0|-0.9|4.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||4.0|-0.9|0.2027
91672797|NCT02310763|183240394|SUPERIORITY||Mean Difference (Net)|2.9||||0.0926|TWO_SIDED|95.0|-0.5|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||6.3|-0.5|0.0926
91672798|NCT02310763|183240395|SUPERIORITY||Mean Difference (Net)|2.0||||0.3597|TWO_SIDED|95.0|-2.4|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||6.3|-2.4|0.3597
91672799|NCT02310763|183240395|SUPERIORITY||Mean Difference (Net)|0.5||||0.7345|TWO_SIDED|95.0|-2.3|3.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.3|-2.3|0.7345
91792947|NCT01709578|183463377|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.283|-0.658||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.658|-1.283|<0.0001
91672800|NCT02310763|183240395|SUPERIORITY||Mean Difference (Net)|4.0||||0.032|TWO_SIDED|95.0|0.4|7.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||7.7|0.4|0.0320
91672801|NCT02310763|183240396|SUPERIORITY||Mean Difference (Net)|1.2||||0.3345|TWO_SIDED|95.0|-1.3|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.8|-1.3|0.3345
91672802|NCT02310763|183240396|SUPERIORITY||Mean Difference (Net)|-1.2||||0.14|TWO_SIDED|95.0|-2.9|0.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.4|-2.9|0.1400
91792948|NCT01709578|183463377|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.444|||<|0.0001|TWO_SIDED|95.0|-1.752|-1.135||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.135|-1.752|<0.0001
91526427|NCT02100722|182928020|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
91526428|NCT02100722|182928021|OTHER||||||<|0.04|||||||Fisher Exact|||||||<0.04
91672803|NCT02310763|183240396|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6764|TWO_SIDED|95.0|-5.4|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.6|-5.4|0.6764
91672804|NCT02310763|183240397|SUPERIORITY||Mean Difference (Net)|6.5||||0.097|TWO_SIDED|95.0|-1.2|14.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||14.2|-1.2|0.0970
91672805|NCT02310763|183240397|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6919|TWO_SIDED|95.0|-1.9|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||1.3|-1.9|0.6919
91672806|NCT02310763|183240397|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6736|TWO_SIDED|95.0|-5.8|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.9|-5.8|0.6736
91672807|NCT02310763|183240398|SUPERIORITY||Mean Difference (Net)|0.0||||0.9582|TWO_SIDED|95.0|-1.5|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||1.5|-1.5|0.9582
91672808|NCT02310763|183240398|SUPERIORITY||Mean Difference (Net)|-0.1||||0.8629|TWO_SIDED|95.0|-1.8|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.5|-1.8|0.8629
91672809|NCT02310763|183240398|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6746|TWO_SIDED|95.0|-5.5|3.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.7|-5.5|0.6746
91672810|NCT02310763|183240399|SUPERIORITY||Mean Difference (Net)|-5.8||||0.7483|TWO_SIDED|95.0|-42.4|30.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||30.7|-42.4|0.7483
91672811|NCT02310763|183240399|SUPERIORITY||Mean Difference (Net)|-1.3||||0.9053|TWO_SIDED|95.0|-23.9|21.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||21.2|-23.9|0.9053
91639202|NCT04550234|183169749|OTHER||Geometric mean ratio|96.39|||||TWO_SIDED|90.0|81.23|114.39||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||114.39|81.23|
91639203|NCT04550234|183169749|OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.08|99.4||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||99.40|91.08|
91639204|NCT01399619|183169754|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-value corresponds to a two sided test against the historical rate of 40%.|normal approximation|||the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.||||<0.0001
91639205|NCT03814499|183169786|OTHER||Coefficient|-2.3|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
91639206|NCT03814499|183169787|OTHER||Coefficient|-3.8|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
91639207|NCT03814499|183169788|OTHER||Coefficient|369.9||||0.3269|TWO_SIDED||||||Regression, Linear|||||||0.3269
91639208|NCT03814499|183169789|OTHER||Coefficient|365.4||||0.4265|TWO_SIDED||||||Regression, Linear|||||||0.4265
91639209|NCT03814499|183169790|OTHER||Coefficient|264.3||||0.4782|TWO_SIDED||||||Regression, Linear|||||||0.4782
91639210|NCT03814499|183169791|OTHER||Coefficient|730.2||||0.2716|TWO_SIDED||||||Regression, Linear|||||||0.2716
91639211|NCT03814499|183169792|OTHER||Coefficient|-0.6||||0.4178|TWO_SIDED||||||Regression, Linear|||||||0.4178
91672812|NCT02310763|183240399|SUPERIORITY||Mean Difference (Net)|13.1||||0.6896|TWO_SIDED|95.0|-53.4|79.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||79.7|-53.4|0.6896
91639212|NCT03814499|183169793|OTHER||Coefficient|-1.5||||0.2677|TWO_SIDED||||||Regression, Linear|||||||0.2677
91639213|NCT03814499|183169794|OTHER||Coefficient|-467.0||||0.3364|TWO_SIDED||||||Regression, Linear|||||||0.3364
91639214|NCT03814499|183169795|OTHER||Coefficient|-908.0||||0.1124|TWO_SIDED||||||Regression, Linear|||||||0.1124
91639215|NCT03814499|183169796|OTHER||Coefficient|479.2||||0.2649|TWO_SIDED||||||Regression, Linear|||||||0.2649
91672813|NCT02310763|183240400|SUPERIORITY||Mean Difference (Net)|-3.7||||0.8117|TWO_SIDED|95.0|-34.8|27.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||27.5|-34.8|0.8117
91672814|NCT02310763|183240400|SUPERIORITY||Mean Difference (Net)|7.3||||0.6018|TWO_SIDED|95.0|-20.6|35.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||35.2|-20.6|0.6018
91526429|NCT02100722|182928022|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91526430|NCT02100722|182928025|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91639216|NCT03814499|183169797|OTHER||Coefficient|1114.3||||0.216|TWO_SIDED||||||Regression, Linear|||||||0.216
91639217|NCT03814499|183169798|OTHER||Coefficient|0.1||||0.9032|TWO_SIDED||||||Regression, Linear|||||||0.9032
91639218|NCT03814499|183169799|OTHER||Coefficient|-0.4||||0.7889|TWO_SIDED||||||Regression, Linear|||||||0.7889
91639219|NCT03814499|183169800|OTHER||Coefficient|7.0||||0.0242|TWO_SIDED||||||Regression, Linear|||||||0.0242
91639220|NCT03814499|183169801|OTHER||Coefficient|1.5||||0.5092|TWO_SIDED||||||Regression, Linear|||||||0.5092
91639221|NCT03814499|183169802|OTHER||Coefficient|-47.1||||0.3634|TWO_SIDED||||||Regression, Linear|||||||0.3634
91639222|NCT03814499|183169803|OTHER||Coefficient|-204.7||||0.0677|TWO_SIDED||||||Regression, Linear|||||||0.0677
91639223|NCT03814499|183169804|OTHER||Coefficient|-235.8||||0.156|TWO_SIDED||||||Regression, Linear|||||||0.156
91639224|NCT03814499|183169805|OTHER||Coefficient|-102.0||||0.3148|TWO_SIDED||||||Regression, Linear|||||||0.3148
91639225|NCT03814499|183169806|OTHER||Coefficient|-0.1||||0.9349|TWO_SIDED||||||Regression, Linear|||||||0.9349
91639226|NCT03814499|183169807|OTHER||Coefficient|-0.6||||0.7196|TWO_SIDED||||||Regression, Linear|||||||0.7196
91639227|NCT03814499|183169808|OTHER||Coefficient|4.7||||0.0542|TWO_SIDED||||||Regression, Linear|||||||0.0542
91639228|NCT03814499|183169809|OTHER||Coefficient|2.6||||0.4224|TWO_SIDED||||||Regression, Linear|||||||0.4224
91639229|NCT03814499|183169810|OTHER||Coeffiient|-118.9||||0.1247|TWO_SIDED||||||Regression, Linear|||||||0.1247
91639230|NCT03814499|183169811|OTHER||Coefficient|-135.2||||0.1461|TWO_SIDED||||||Regression, Linear|||||||0.1461
91639231|NCT03814499|183169812|OTHER||Coefficient|-154.2||||0.0699|TWO_SIDED||||||Regression, Linear|||||||0.0699
91639232|NCT03814499|183169813|OTHER||Coefficient|-164.6||||0.0901|TWO_SIDED||||||Regression, Linear|||||||0.0901
91639233|NCT03417245|183169814|SUPERIORITY||ABR ratio|0.101|||<|0.0001|TWO_SIDED|95.0|0.064|0.159||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression mode|||||0.159|0.064|<0.0001
91639234|NCT03417245|183169816|SUPERIORITY||ABR ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.09|0.188||P-value derived from NB regression model during TP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.188|0.090|<0.0001
91639235|NCT03417245|183169818|SUPERIORITY||ABR ratio|0.083|||<|0.0001|TWO_SIDED|95.0|0.049|0.141||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.141|0.049|<0.0001
91639236|NCT03417245|183169820|SUPERIORITY||ABR ratio|0.097|||<|0.0001|TWO_SIDED|95.0|0.059|0.161||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.161|0.059|<0.0001
91672815|NCT02310763|183240400|SUPERIORITY||Mean Difference (Net)|16.3||||0.7152|TWO_SIDED|95.0|-73.4|106.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||106.0|-73.4|0.7152
91672816|NCT02310763|183240401|SUPERIORITY||Mean Difference (Net)|7.0||||0.719|TWO_SIDED|95.0|-32.1|46.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||46.1|-32.1|0.7190
91672817|NCT02310763|183240401|SUPERIORITY||Mean Difference (Net)|-15.8||||0.4634|TWO_SIDED|95.0|-58.9|27.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||27.3|-58.9|0.4634
91672818|NCT02310763|183240401|SUPERIORITY||Mean Difference (Net)|3.9||||0.94|TWO_SIDED|95.0|-100.7|108.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||108.5|-100.7|0.9400
91672819|NCT02310763|183240405|SUPERIORITY||Mean Difference (Net)|2.945||||0.0087|TWO_SIDED|95.0|0.7597|5.1309||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||5.1309|0.7597|0.0087
91672820|NCT02310763|183240405|SUPERIORITY||Mean Difference (Net)|2.918||||0.0536|TWO_SIDED|95.0|-0.0461|5.8811||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.8811|-0.0461|0.0536
91672821|NCT02310763|183240405|SUPERIORITY||Mean Difference (Net)|4.087||||0.0298|TWO_SIDED|95.0|0.4069|7.7677||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.7677|0.4069|0.0298
91672822|NCT02310763|183240406|SUPERIORITY||Mean Difference (Net)|1.575||||0.0684|TWO_SIDED|95.0|-0.1213|3.2715||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||3.2715|-0.1213|0.0684
91672823|NCT02310763|183240406|SUPERIORITY||Mean Difference (Net)|2.612||||0.0376|TWO_SIDED|95.0|0.1521|5.0711||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.0711|0.1521|0.0376
91672824|NCT02310763|183240406|SUPERIORITY||Mean Difference (Net)|3.208||||0.0411|TWO_SIDED|95.0|0.1318|6.2844||The significance level is 0.05|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||6.2844|0.1318|0.0411
91672825|NCT03396874|183240463|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|87.3|||<|1e-07|TWO_SIDED|95.0|81.58|100.0||The exact p-value cannot be entered as it is equal to 2.2e-16.|Exact binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||We determined the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence or absence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|81.58|<0.0000001
91672826|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|92.3|||<|1e-07|TWO_SIDED|95.0|90.0|100.0||Per patient basis p-value = 2.2e-16|binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||PPV, composite standard, per-patient basis: We determined the positive predictive value (PPV) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100|90.0|<0.0000001
91672827|NCT03396874|183240464|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|95.29|||<|1e-07|TWO_SIDED|95.0|93.3|100.0||Per patient basis p-value = 2.2e-16|Sensitivity|||Sensitivity, composite standard, per-patient basis: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). On a per-patient basis, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.3|<0.0000001
91672828|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.1|||<|1e-07|TWO_SIDED|95.0|86.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, prostate or prostate bed: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|86.2|<0.0000001
91672829|NCT03396874|183240464|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.72|||<|1e-07|TWO_SIDED|95.0|86.74|100.0||p-value = 2.2e-16 Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Exact binomial proportion test|||Sensitivity, composite standard, prostate/prostate bed: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In the prostate or prostate bed, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.74|<0.0000001
91672830|NCT03396874|183240464|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|90.78|||<|1e-07|TWO_SIDED|95.0|85.74|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, pelvic lymph nodes: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|85.74|<0.0000001
91672831|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|96.97|||<|1e-07|TWO_SIDED|95.0|93.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, pelvic lymph nodes: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In pelvic lymph nodes, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.20|<0.0000001
91639237|NCT03417245|183169822|SUPERIORITY||Least Square (LS) Mean difference|-19.75|||<|0.0001|TWO_SIDED|95.0|-27.0|-12.5||Analysis of Covariance (ANCOVA) model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-12.50|-27.00|<0.0001
91639238|NCT03417245|183169823|SUPERIORITY||LS Mean difference|-7.07|||=|0.0011|TWO_SIDED|95.0|-11.23|-2.9||ANCOVA model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-2.90|-11.23|=0.0011
91639239|NCT00598442|183169832|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|97.5|-0.09|0.36|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.36|-0.09|
91639240|NCT00598442|183169832|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|97.5|0.08|0.54|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.54|0.08|
91639241|NCT00598442|183169833|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.28|||||TWO_SIDED|95.0|1.04|5.01|||Cochran-Mantel-Haenszel|||||5.01|1.04|
91639242|NCT00598442|183169833|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.94|4.69|||Cochran-Mantel-Haenszel|||||4.69|0.94|
91639243|NCT00598442|183169834|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|
91639244|NCT00598442|183169834|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.93|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.93|
91639245|NCT00398476|183169878|OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Analysis for overall product preference||||0.003
91672832|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|91.25|||<|1e-07|TWO_SIDED|95.0|84.19|100.0||p-value = 2.9e-15|Exact binomial proportion test|||PPV, composite standard, soft tissues: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In soft tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|84.19|<0.0000001
91672833|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|93.59|||<|1e-07|TWO_SIDED|95.0|86.99|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, soft tissues: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In soft tissues, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.99|<0.0000001
91792949|NCT01709578|183463378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958|||<|0.0001|TWO_SIDED|95.0|1.764|4.959||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.959|1.764|<0.0001
91639246|NCT00398476|183169878|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Scent/odor||||<0.001
91639247|NCT00398476|183169878|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Immediate taste||||<0.001
91639248|NCT00398476|183169878|OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Analysis for After-taste||||0.002
91639249|NCT00398476|183169878|OTHER|||||||0.037|||||||Cochran-Mantel-Haenszel|||Analysis for Less drip down throat||||0.037
91639250|NCT00398476|183169878|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Less run out nose||||<0.001
91639251|NCT00398476|183169878|OTHER|||||||0.408|||||||Cochran-Mantel-Haenszel|||Analysis for More soothing||||0.408
91639252|NCT00398476|183169878|OTHER|||||||0.07|||||||Cochran-Mantel-Haenszel|||Analysis for Less irritating||||0.070
91639253|NCT00398476|183169878|OTHER|||||||0.587|||||||Cochran-Mantel-Haenszel|||Analysis for Urge to sneeze||||0.587
91639254|NCT00398476|183169879|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-2.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ items||||<0.001
91639255|NCT00398476|183169879|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-1.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ items||||<0.001
91639256|NCT00398476|183169880|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.255||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||0.255
91639257|NCT00398476|183169881|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.056||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for all DAQ items||||0.056
91639258|NCT00398476|183169882|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.845||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ Irtems||||0.845
91639259|NCT00398476|183169883|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.871||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ Items||||0.871
91639260|NCT00398476|183169884|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91639261|NCT00398476|183169885|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.592||95.0|||||Cochran-Mantel-Haenszel|||||||0.592
91639262|NCT00398476|183169886|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91639263|NCT00398476|183169887|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.434||95.0|||||Cochran-Mantel-Haenszel|||||||0.434
91639264|NCT00398476|183169888|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.797
91639265|NCT00398476|183169888|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.296|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.296
91672834|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|95.17|||<|1e-07|TWO_SIDED|95.0|91.12|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, bone: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In bone tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|91.12|<0.0000001
91722540|NCT02629159|183337903|SUPERIORITY||LS Mean Difference|1.51||||0.017|TWO_SIDED|95.0|0.27|2.76||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.76|0.27|0.017
91639266|NCT00398476|183169889|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||<0.001
91639267|NCT00398476|183169889|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in DAQ||||<0.001
91639268|NCT00398476|183169890|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.968|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.968
91639269|NCT00398476|183169890|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Mean Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.797
91639270|NCT00398476|183169891|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.221|||||||Cochran-Mantel-Haenszel|||||||0.221
91639271|NCT00398476|183169892|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.205|||||||Cochran-Mantel-Haenszel|||||||0.205
91639272|NCT00398476|183169893|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.108|||||||Cochran-Mantel-Haenszel|||||||0.108
91639273|NCT00398476|183169894|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.694|||||||Cochran-Mantel-Haenszel|||||||0.694
91672835|NCT03396874|183240464|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|100.0|||<|1e-07|TWO_SIDED|95.0|97.85|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, bone: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In bone, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|97.85|<0.0000001
91672836|NCT02563769|183240565|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91672837|NCT02563769|183240565|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91672838|NCT02598895|183240569|OTHER|||||||||||||||||The primary efficacy endpoint was percent patients achieving PSA decline of 50% or more from baseline (PSA50), assessed in the time prior to disease progression, unacceptable toxicity or 1 year after the last study medication. The historical comparison was PSA50 of 26%. The target response rate was 60%. The study followed an optimal two-stage Simon design (Simon, 1989) where the null hypothesis that the true PSA response rate PSA50 was 0.26 was tested against a one-sided alternative.|See above|||
91672839|NCT00842530|183240589|SUPERIORITY|The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|30.2|||||TWO_SIDED|95.0|-13.4|56.6||||||Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.||56.6|-13.4|
91672840|NCT00842530|183240590|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|75.2|||||TWO_SIDED|95.0|-377.0|99.6||||||Vaccine efficacy against severe VCD (IDMC)||99.6|-377|
91715929|NCT01674725|183322616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|94.6|
91715930|NCT01674725|183322617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91715931|NCT01674725|183322618|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|||100.0|94.6|
91715932|NCT01674725|183322618|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority|||100|95.9|
91715933|NCT01674725|183322618|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Percentage of Participants|2.3|||||TWO_SIDED|95.0|-0.8|5.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|||5.4|-0.8|
91485577|NCT03438383|182844267|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.75||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.75
91672841|NCT00842530|183240590|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|50.3|||||TWO_SIDED|95.0|-585.0|96.4||||||Vaccine efficacy of against severe VCD (WHO 1999)||96.4|-585|
91672842|NCT00842530|183240591|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|41.5|||||TWO_SIDED|95.0|-38.4|74.9||||||Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 3||74.9|-38.4|
91672843|NCT00842530|183240591|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|35.3|||||TWO_SIDED|95.0|3.3|56.5||||||Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase||56.5|3.3|
91715934|NCT02709746|183322632|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.4702|TWO_SIDED|95.0|-1.94|4.2|||Mixed Model Repeated Analysis|||||4.2|-1.94|0.4702
91526431|NCT03500640|182928038|SUPERIORITY|||||||0.196||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.196
91639274|NCT00398476|183169895|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
91639275|NCT03764813|183169910|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
91639276|NCT03764813|183169911|SUPERIORITY||Median Difference (Final Values)|0.165|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91639277|NCT03764813|183169912|SUPERIORITY||Median Difference (Final Values)|0.537|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91639278|NCT03764813|183169913|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
91639279|NCT03602976|183169973|SUPERIORITY||Mean Difference (Final Values)|190.7||||0.059|TWO_SIDED||||||t-test, 2 sided|||For GGT||||0.059
91639280|NCT03602976|183169973|SUPERIORITY||Mean Difference (Final Values)|55.5||||0.23|TWO_SIDED||||||t-test, 2 sided|||For Alkaline Phosphatase||||0.23
91639281|NCT03602976|183169974|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
91639282|NCT03602976|183169975|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
91672844|NCT00842530|183240597|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|33.4|||||TWO_SIDED|95.0|4.1|53.5||||||Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase||53.5|4.1|
91672845|NCT00842530|183240597|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|34.9|||||TWO_SIDED|95.0|6.7|54.3||||||Vaccine efficacy: Day 0 up to end of Active Phase||54.3|6.7|
91715935|NCT02709746|183322632|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.6373|TWO_SIDED|95.0|-3.71|2.27|||Mixed Model Repeated Analysis|||||2.27|-3.71|0.6373
91639283|NCT03602976|183169976|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.094|TWO_SIDED||||||t-test, 2 sided|||||||0.094
91639284|NCT03602976|183169977|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
91639285|NCT04837807|183169978|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_DEVIATION|12.8|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||"Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as better scores thus representing more comfort than previous weeks."||||<0.05
91715936|NCT02709746|183322632|SUPERIORITY||Mean Difference (Final Values)|-3.73||||0.0152|TWO_SIDED|95.0|-6.74|-0.72|||Mixed Model Repeated Analysis|||||-0.72|-6.74|0.0152
91639286|NCT04837807|183169980|SUPERIORITY|OSDI scores were obtained across all three visits, baseline, week 1 and week 2. Lower OSDI scores indicate better eye health.|Mean Difference (Final Values)|10.5|STANDARD_DEVIATION|7.3|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||||||<0.05
91639287|NCT00920582|183170000|SUPERIORITY||Odds Ratio (OR)|1.348||||0.609|TWO_SIDED|95.0|0.431|4.219|||Mantel Haenszel|||||4.219|0.431|0.609
91639288|NCT00920582|183170000|SUPERIORITY||Odds Ratio (OR)|1.356||||0.601|TWO_SIDED|95.0|0.453|4.23|||Mantel Haenszel|||||4.230|0.453|0.601
91639289|NCT00920582|183170000|SUPERIORITY||Odds Ratio (OR)|1.624||||0.4|TWO_SIDED|95.0|0.521|5.066|||Mantel Haenszel|||||5.066|0.521|0.400
91639290|NCT00920582|183170002|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.365|TWO_SIDED|95.0|-0.086|0.031|||ANCOVA|||||0.031|-0.086|0.365
91639291|NCT00920582|183170002|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.842|TWO_SIDED|95.0|-0.078|0.064|||ANCOVA|||||0.064|-0.078|0.842
91639292|NCT00920582|183170002|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.565|TWO_SIDED|95.0|-0.089|0.171|||ANCOVA|||||0.171|-0.089|0.565
91639293|NCT00920582|183170007|SUPERIORITY||Odds Ratio (OR)|2.197||||0.142|TWO_SIDED|95.0|0.764|6.312|||Mantel Haenszel|||||6.312|0.764|0.142
91639294|NCT00920582|183170007|SUPERIORITY||Odds Ratio (OR)|1.487||||0.46|TWO_SIDED|95.0|0.517|4.278|||Mantel Haenszel|||||4.278|0.517|0.460
91639295|NCT00920582|183170007|SUPERIORITY||Odds Ratio (OR)|1.954||||0.199|TWO_SIDED|95.0|0.69|5.532|||Mantel Haenszel|||||5.532|0.690|0.199
91639296|NCT03319160|183170011|OTHER||Incidence per 100 patient-years|7.5|STANDARD_DEVIATION|2.74|||TWO_SIDED|95.0|6.3|8.7|||||"Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events).~Length of exposure: 253 patient-years."|||8.7|6.3|
91639297|NCT03319160|183170013|OTHER||Incidence per 100 patient-years|3.2|STANDARD_DEVIATION|1.78|||TWO_SIDED|95.0|1.9|4.4|||||||Poisson distribution assumed due to the infrequent nature of the events. Number of inappropriately shocked events: 8. Length of exposure: 253 patient-years.|4.4|1.9|
91639298|NCT04533204|183170028|SUPERIORITY||Mean Difference (Final Values)|18.47|||<|0.001|TWO_SIDED|95.0|12.28|24.67|||Mixed Models Analysis|||||24.67|12.28|<.001
91639299|NCT04533204|183170029|SUPERIORITY||Mean Difference (Final Values)|2.33||||0.004|TWO_SIDED|95.0|0.75|3.91||Performance on cued recall (error scores)|Mixed Models Analysis|||||3.91|.75|.004
91639300|NCT02260791|183170031|EQUIVALENCE|-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-7.3|3.6||||||The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.||3.6|-7.3|
91715937|NCT02709746|183322632|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.8778|TWO_SIDED|95.0|-2.41|2.82|||Mixed Model Repeated Analysis|||||2.82|-2.41|0.8778
91715938|NCT03074695|183322660|OTHER||Risk Difference (RD)|3.03||||0.766|TWO_SIDED|95.0|-14.02|20.08|||Regression, Logistic|Adjusted for baseline characteristics (parturient race, ethnicity, height, and induction status).||||20.08|-14.02|0.766
91715939|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.54||||0.048|TWO_SIDED|95.0|1.0|2.36|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:~This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||2.36|1.0|0.048
91715940|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.16||||0.5|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate||1.81|.75|0.50
91639301|NCT02260791|183170032|EQUIVALENCE|If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between -0.6 and +0.6 then FKB327 was considered equivalent to Humira.|Difference in least square mean|0.01|||||TWO_SIDED|95.0|-0.16|0.18||||||The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.||0.18|-0.16|
91715941|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|0.97|0.97|1.03|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.03|0.97|0.90
91672846|NCT02243293|183240604|NON_INFERIORITY|The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|98.5|||||TWO_SIDED|95.0|96.5|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|||100.0|96.5|
91672847|NCT04117945|183240608|SUPERIORITY|||||||0.8874|||||||One-sided unstratified log-rank|||||||0.8874
91672848|NCT04117945|183240609|SUPERIORITY|||||||0.9683|||||||One-sided unstratified log-rank|||||||0.9683
91672849|NCT04117945|183240610|SUPERIORITY|||||||0.0448|||||||One-sided unstratified log-rank|||||||0.0448
91672850|NCT04117945|183240611|SUPERIORITY|||||||0.9007|||||||One-sided unstratified log-rank|||||||0.9007
91715942|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.17||||0.024|TWO_SIDED|95.0|1.02|1.34|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.34|1.02|0.024
91526432|NCT03500640|182928039|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.800
91672851|NCT01769274|183240628|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
91672852|NCT01769274|183240628|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
91672853|NCT02409329|183240647|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.313||||0.0493|TWO_SIDED|95.0|-0.61|-0.017||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||-0.017|-0.610|.0493
91672854|NCT02409329|183240647|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.07||||0.26|TWO_SIDED|95.0|-0.38|0.24||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.240|-0.380|0.260
91715943|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.32||||0.045|TWO_SIDED|95.0|1.01|1.72|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.72|1.01|0.045
91526433|NCT03500640|182928040|SUPERIORITY|||||||0.677|||||||t-test, 2 sided|||||||0.677
91639302|NCT00280059|183170072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.24|-0.09|||Gart and Nam: correction of skewness||95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.|Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.||-0.09|-0.24|
91526434|NCT03500640|182928041|SUPERIORITY|||||||0.349||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.349
91639303|NCT00280059|183170073|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.0034|TWO_SIDED|95.0|0.6|0.9||Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.|Regression, Cox|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \> 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||0.90|0.60|0.0034
91639304|NCT00280059|183170074|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.06||||0.8047|TWO_SIDED|95.0|0.65|1.74||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.74|0.65|0.8047
91639305|NCT00280059|183170075|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.2537|TWO_SIDED|95.0|0.88|1.6||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.60|0.88|0.2537
91639306|NCT00280059|183170076|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|6.52||||0.0025|TWO_SIDED|95.0|1.93|22.04||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||22.04|1.93|0.0025
91639307|NCT00280059|183170077|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.0744|TWO_SIDED|95.0|0.97|1.91||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.91|0.97|0.0744
91639308|NCT00280059|183170078|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.47||||0.0003|TWO_SIDED|95.0|1.19|1.8||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.80|1.19|0.0003
91639309|NCT00280059|183170088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.0025|TWO_SIDED|95.0|0.3|1.4|||ANCOVA|||Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.4|0.3|0.0025
91639310|NCT00280059|183170088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0186|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.1|0.1|0.0186
91639311|NCT00280059|183170089|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.0683|TWO_SIDED|95.0|0.98|1.93|||Regression, Logistic|||Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.93|0.98|0.0683
91639312|NCT00280059|183170089|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.5096|TWO_SIDED|95.0|0.78|1.66|||Regression, Logistic|||Week 32: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.66|0.78|0.5096
91639313|NCT00280059|183170089|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6804|TWO_SIDED|95.0|0.73|1.63|||Regression, Logistic|||Week 56 (termination): dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.63|0.73|0.6804
91639314|NCT02549040|183170116|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.09|0.85|
91526435|NCT03500640|182928042|SUPERIORITY|||||||0.891|||||||t-test, 2 sided|||||||0.891
91639315|NCT02549040|183170116|OTHER||Geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.02|1.26||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.26|1.02|
91792950|NCT01709578|183463378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.374|||<|0.0001|TWO_SIDED|95.0|2.045|5.566||Threshold for significance was 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.566|2.045|<0.0001
91526436|NCT03500640|182928043|SUPERIORITY|||||||0.14||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.140
91485578|NCT03438383|182844267|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.09||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.09
91639316|NCT02549040|183170116|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.88|1.11||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.11|0.88|
91639317|NCT02549040|183170116|OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.8|0.99||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.99|0.80|
91639318|NCT02549040|183170117|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.98||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.98|0.79|
91639319|NCT02549040|183170117|OTHER||Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.98|1.21||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.21|0.98|
91639320|NCT02549040|183170117|OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.81|1.0||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.00|0.81|
91639321|NCT02549040|183170117|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.97||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.97|0.79|
91639322|NCT02549040|183170118|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.61|0.82||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.82|0.61|
91639323|NCT02549040|183170118|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.75|1.01||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.01|0.75|
91639324|NCT02549040|183170118|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.6|0.81||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.81|0.60|
91639325|NCT02549040|183170118|OTHER||Geometric mean ratio|0.76|||||TWO_SIDED|90.0|0.66|0.86||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.86|0.66|
91639326|NCT02549040|183170119|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.72|0.93||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.93|0.72|
91639327|NCT02549040|183170119|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.94|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.94|
91672855|NCT02409329|183240648|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.406|||<|0.001|TWO_SIDED|95.0|0.196|0.615||A priori threshold p\<.05.|Wald statistic|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.615|0.196|<.001
91526437|NCT03500640|182928044|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|||||||0.732
91639328|NCT02549040|183170119|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.96||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.76|
91639329|NCT02549040|183170119|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.74|0.94||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.74|
91639330|NCT02549040|183170122|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.75|0.94||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.75|
91639331|NCT02549040|183170122|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|0.95|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.95|
91639332|NCT02549040|183170122|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.95|0.76|
91639333|NCT02549040|183170122|OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.77|
91639334|NCT02777554|183170429|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% confidence intervals (CIs) of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|101.6|||||TWO_SIDED|90.0|95.1|108.5|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an analysis of variance (ANOVA) model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 Cmax.||108.5|95.1|
91639335|NCT02777554|183170430|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% CIs of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|95.3|||||TWO_SIDED|90.0|88.9|102.2|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an ANOVA model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 AUC0-24.||102.2|88.9|
91672856|NCT02409329|183240648|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.21||||0.003|TWO_SIDED|95.0|-0.031|0.45||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.450|-0.031|0.003
91672857|NCT02409329|183240649|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.54||||0.376|TWO_SIDED|95.0|-0.012|1.09||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.090|-0.012|0.376
91672858|NCT02409329|183240649|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.278||||0.434|TWO_SIDED|95.0|-0.319|0.875||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.875|-0.319|0.434
91672859|NCT02409329|183240650|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.399||||0.0012|TWO_SIDED|95.0|0.16|0.637||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations||0.637|0.160|0.0012
91672860|NCT02409329|183240650|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.152||||0.003|TWO_SIDED|95.0|-0.121|0.426||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.426|-0.121|0.003
91672861|NCT02409329|183240651|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.061||||0.632|TWO_SIDED|95.0|-0.218|0.095||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.095|-0.218|0.632
91672862|NCT02409329|183240651|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.005||||0.572|TWO_SIDED|95.0|-0.202|1.1||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.100|-0.202|0.572
91715944|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.11||||0.31|TWO_SIDED|95.0|0.9|1.37|||Regression, Cox|||Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.37|0.90|0.31
91715945|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.07||||0.51|TWO_SIDED|95.0|0.88|1.29|||Regression, Cox|||cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.29|0.88|0.51
91792951|NCT01709578|183463379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.0002|TWO_SIDED|95.0|1.774|7.332||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.332|1.774|0.0002
91672863|NCT02409329|183240652|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|369.0||||0.703|TWO_SIDED|95.0|-142.0|881.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||881|-142|0.703
91672864|NCT02409329|183240652|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|26.0||||0.465|TWO_SIDED|95.0|-459.0|511.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||511|-459|0.465
91672865|NCT02409329|183240653|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.75|||||TWO_SIDED|95.0|-1.38|-0.12|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.12|-1.38|
91672866|NCT02409329|183240653|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-1.0|0.39|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.39|-1.00|
91672867|NCT02409329|183240653|SUPERIORITY|Testing superiority of REACH\_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.65|||||TWO_SIDED|95.0|-1.26|-0.05|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.05|-1.26|
91715946|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.79|1.26|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.26|0.79|0.9700
91715947|NCT00902577|183322670|OTHER||Hazard Ratio (HR)|0.99||||0.9007|TWO_SIDED|95.0|0.91|1.09|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.09|0.91|0.9007
91715948|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|1.24||||0.33|TWO_SIDED|95.0|0.8|1.91|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.91|.80|0.33
91715949|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|0.93||||0.72|TWO_SIDED|95.0|0.61|1.4|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.4|.61|0.72
91715950|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|1.01||||0.355|TWO_SIDED|95.0|0.98|1.04|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.04|.98|0.355
91715951|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|1.1||||0.074|TWO_SIDED|95.0|0.99|1.23|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.23|0.99|0.074
91792952|NCT01709578|183463379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.0056|TWO_SIDED|95.0|1.308|5.383||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.383|1.308|0.0056
91672868|NCT02409329|183240653|SUPERIORITY|Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-0.96|0.51|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.51|-0.96|
91639336|NCT02777554|183170431|OTHER||Ratio (%) of Geometric Means|103.9|||||TWO_SIDED|90.0|93.6|115.4|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||115.4|93.6|
91639337|NCT02777554|183170431|OTHER||Ratio (%) of Geometric Means|90.9|||||TWO_SIDED|90.0|81.6|101.3|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||101.3|81.6|
91639338|NCT02777554|183170431|OTHER||Ratio (%) of Geometric Means|115.0|||||TWO_SIDED|90.0|103.3|128.1|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||128.1|103.3|
91639339|NCT02777554|183170431|OTHER||Ratio (%) of Geometric Means|126.5|||||TWO_SIDED|90.0|113.7|140.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||140.8|113.7|
91639340|NCT02777554|183170432|OTHER||Ratio (%) of Geometric Means|92.9|||||TWO_SIDED|90.0|81.3|106.2|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||106.2|81.3|
91639341|NCT02777554|183170432|OTHER||Ratio (%) of Geometric Means|86.0|||||TWO_SIDED|90.0|74.9|98.7|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||98.7|74.9|
91639342|NCT02777554|183170432|OTHER||Ratio (%) of Geometric Means|97.3|||||TWO_SIDED|90.0|84.9|111.6|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||111.6|84.9|
91639343|NCT02777554|183170432|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||129.7|98.8|
91639344|NCT02777554|183170433|OTHER||Ratio (%) of Geometric Means|92.6|||||TWO_SIDED|90.0|81.1|105.9|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||105.9|81.1|
91639345|NCT02777554|183170433|OTHER||Ratio (%) of Geometric Means|86.1|||||TWO_SIDED|90.0|75.0|98.8|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||98.8|75.0|
91639346|NCT02777554|183170433|OTHER||Ratio (%) of Geometric Means|97.5|||||TWO_SIDED|90.0|85.0|111.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||111.8|85.0|
91672869|NCT03200535|183240672|SUPERIORITY|Superiority analysis|||||<|0.001|||||||Chi-squared|||||||<0.001
91672870|NCT03200535|183240673|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91672871|NCT03291041|183240674|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|34.75||||0.0354|TWO_SIDED||||||ANCOVA|||||||0.0354
91672872|NCT03291041|183240675|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-0.63||||0.0168|TWO_SIDED||||||ANCOVA|||||||0.0168
91672873|NCT03291041|183240676|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|90.56||||0.0785|TWO_SIDED||||||ANCOVA|||||||0.0785
91672874|NCT03291041|183240677|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|78.45||||0.0225|TWO_SIDED||||||ANCOVA|||||||0.0225
91672875|NCT03291041|183240678|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|0.95||||0.0198|TWO_SIDED||||||ANCOVA|||||||0.0198
91672876|NCT03291041|183240679|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-26.55||||0.0347|TWO_SIDED||||||ANCOVA|||||||0.0347
91672877|NCT03291041|183240680|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-56.44||||0.084|TWO_SIDED||||||ANCOVA|||||||0.0840
91672878|NCT03291041|183240681|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0765|TWO_SIDED||||||ANCOVA|||||||0.0765
91672879|NCT04184999|183240695|SUPERIORITY||F-Statistic|207.4|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
91672880|NCT01172821|183240696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.159|0.264|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.264|0.159|<0.0001
91672881|NCT01172821|183240696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.116|0.222|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.222|0.116|<0.0001
91672882|NCT01172821|183240697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.12|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.120|<0.0001
91672883|NCT01172821|183240697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.076|0.19|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.190|0.076|<0.0001
91672884|NCT01172821|183240698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|0.052|0.168|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.168|0.052|0.0002
91672885|NCT01172821|183240698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.03||0.0031|TWO_SIDED|95.0|0.03|0.147|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.147|0.030|0.0031
91672886|NCT01172821|183240699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.032||0.0061|TWO_SIDED|95.0|0.025|0.149|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.149|0.025|0.0061
91672887|NCT01172821|183240699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.032||0.0093|TWO_SIDED|95.0|0.021|0.146|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.146|0.021|0.0093
91672888|NCT01172821|183240700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.252|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.252|0.150|<0.0001
91672889|NCT01172821|183240700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.112|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.112|<0.0001
91526438|NCT03500640|182928045|SUPERIORITY|||||||0.637||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.637
91639347|NCT02777554|183170433|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||129.7|98.8|
91639348|NCT01966458|183170466|NON_INFERIORITY|A non-inferiority margin of 6% was pre-specified.|Risk Difference (RD)|2.6||||0.1444|TWO_SIDED|90.0|-5.5|10.7|||Farrington-Manning asymptotic test||Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.|The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.||10.7|-5.5|0.1444
91639349|NCT01966458|183170467|SUPERIORITY||Percent of Participants|19.2||||0.7363|TWO_SIDED|90.0|15.6|23.3|||Exact Binomial Test||Two-sided exact binomial confidence interval used|The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.||23.3|15.6|0.7363
91639350|NCT01966458|183170468|NON_INFERIORITY|The non-inferiority margin on the difference in success proportions is 15%.|Difference in Percentages|-9.2|||<|0.0001|TWO_SIDED|90.0|-17.2|-1.1|||Farrington-Manning asymptotic test||Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used|||-1.1|-17.2|<0.0001
91639351|NCT01966458|183170468|SUPERIORITY|||||||0.0354|||||||Chi-squared|||||||0.0354
91639352|NCT01458535|183170469|SUPERIORITY_OR_OTHER|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.157
91639353|NCT01458535|183170469|SUPERIORITY_OR_OTHER|||||||0.999|||||||Cochran-Mantel-Haenszel|||||||0.999
91639354|NCT01458535|183170469|SUPERIORITY_OR_OTHER|||||||0.045|||||||Cochran-Mantel-Haenszel|||||||0.045
91672890|NCT01172821|183240701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.029||0.0002|TWO_SIDED|95.0|0.052|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.052|0.0002
91672891|NCT01172821|183240701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.029||0.0019|TWO_SIDED|95.0|0.033|0.145|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.145|0.033|0.0019
91672892|NCT01172821|183240702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.759|STANDARD_ERROR_OF_MEAN|4.963|<|0.0001|TWO_SIDED|95.0|19.025|38.494|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||38.494|19.025|<0.0001
91672893|NCT01172821|183240702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.178|STANDARD_ERROR_OF_MEAN|4.985|<|0.0001|TWO_SIDED|95.0|18.401|37.956|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||37.956|18.401|<0.0001
91672894|NCT01172821|183240703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.068||0.87|TWO_SIDED|95.0|-0.122|0.144|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.144|-0.122|0.8700
91715952|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.63|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.63|1.04|0.021
91715953|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|1.28||||0.0096|TWO_SIDED|95.0|1.06|1.54|||Regression, Cox|||"Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.~The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.54|1.06|0.0096
91526439|NCT03500640|182928046|SUPERIORITY|||||||0.521||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.521
91639355|NCT00151775|183170476|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0008
91639356|NCT00151775|183170476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
91639357|NCT00151775|183170476|SUPERIORITY_OR_OTHER|||||||0.0032||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0032
91639358|NCT00151775|183170476|SUPERIORITY_OR_OTHER|||||||0.0265||95.0|||||Regression, Linear|||Weight adjusted dosage||||0.0265
91639359|NCT00151775|183170476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||<0.0001
91639360|NCT00151775|183170476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
91672895|NCT01172821|183240703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.068||0.9612|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.130|-0.137|0.9612
91672896|NCT01172821|183240704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.059||0.0305|TWO_SIDED|95.0|-0.241|-0.012|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.012|-0.241|0.0305
91672897|NCT01172821|183240704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.059||0.1602|TWO_SIDED|95.0|-0.198|0.033|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.033|-0.198|0.1602
91672898|NCT01172821|183240705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4012|TWO_SIDED|95.0|0.81|1.74||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.74|0.81|0.4012
91672899|NCT01172821|183240705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||1.1727|TWO_SIDED|95.0|0.67|1.42||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.42|0.67|1.1727
91672900|NCT01172821|183240706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.613|STANDARD_ERROR_OF_MEAN|4.496|<|0.0001|TWO_SIDED|95.0|11.795|29.431|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||29.431|11.795|<0.0001
91672901|NCT01172821|183240706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.757|STANDARD_ERROR_OF_MEAN|4.513|<|0.0001|TWO_SIDED|95.0|15.907|33.607|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.607|15.907|<0.0001
91672902|NCT01172821|183240707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.991|STANDARD_ERROR_OF_MEAN|4.547||0.0004|TWO_SIDED|95.0|7.074|24.908|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||24.908|7.074|0.0004
91672903|NCT01172821|183240707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.247|STANDARD_ERROR_OF_MEAN|4.561|<|0.0001|TWO_SIDED|95.0|12.302|30.193|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||30.193|12.302|<0.0001
91672904|NCT01172821|183240708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.953|STANDARD_ERROR_OF_MEAN|0.598||0.1114|TWO_SIDED|95.0|-2.125|0.22|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.220|-2.125|0.1114
91672905|NCT01172821|183240708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.6||0.7665|TWO_SIDED|95.0|-1.355|0.999|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.999|-1.355|0.7665
91672906|NCT01172821|183240709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.031||0.0111|TWO_SIDED|95.0|0.018|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.018|0.0111
91715954|NCT00902577|183322671|OTHER||Hazard Ratio (HR)|1.18||||0.038|TWO_SIDED|95.0|1.01|1.38|||Regression, Cox|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.~nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.38|1.01|0.038
91526440|NCT03500640|182928047|SUPERIORITY|||||||0.083||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.083
91526441|NCT03500640|182928048|SUPERIORITY|||||||0.778||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.778
91715955|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.682||||0.3253|TWO_SIDED|95.0|0.318|1.463|||Regression, Logistic|||Logistic regression for SUVpeak to predict PFS6||1.463|0.318|0.3253
91526442|NCT03500640|182928049|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.982
91672907|NCT01172821|183240709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.031||0.0395|TWO_SIDED|95.0|0.003|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.003|0.0395
91672908|NCT01172821|183240710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.032||0.0357|TWO_SIDED|95.0|0.005|0.131|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.131|0.005|0.0357
91672909|NCT01172821|183240710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.032||0.0422|TWO_SIDED|95.0|0.002|0.129|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.129|0.002|0.0422
91672910|NCT01172821|183240711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.131||0.1927|TWO_SIDED|95.0|-0.427|0.086|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.086|-0.427|0.1927
91672911|NCT01172821|183240711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.131||0.4053|TWO_SIDED|95.0|-0.148|0.367|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.367|-0.148|0.4053
91672912|NCT01172821|183240712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3501|TWO_SIDED|95.0|-0.079|0.028|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.028|-0.079|0.3501
91672913|NCT01172821|183240712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.028||0.8045|TWO_SIDED|95.0|-0.047|0.061|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.061|-0.047|0.8045
91672914|NCT01172821|183240713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
91672915|NCT01172821|183240713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
91672916|NCT02985879|183240716|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.34|=|0.998|TWO_SIDED|95.0|-2.63|2.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||2.63|-2.63|=0.998
91672917|NCT02985879|183240716|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.32|=|0.464|TWO_SIDED|95.0|-1.63|3.58|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.58|-1.63|=0.464
91672918|NCT02985879|183240718|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.88|=|0.812|TWO_SIDED|95.0|-1.52|1.93|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1.93|-1.52|=0.812
91715956|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.991||||0.9836|TWO_SIDED|95.0|0.403|2.434|||Regression, Logistic|||TBmax was modeled with a univariate logistic regression model for PFS6.||2.434|0.403|0.9836
91715957|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.957||||0.1566|TWO_SIDED|95.0|0.9|1.017|||Regression, Logistic|||Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .||1.017|0.900|0.1566
91715958|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.993||||0.9554|TWO_SIDED|95.0|0.775|1.273|||Regression, Logistic|||"Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate logistic regression model for PFS6."||1.273|0.775|0.9554
91639361|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|0.69||||0.0008||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0008
91792953|NCT01709578|183463380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.622|||<|0.0001|TWO_SIDED|95.0|2.339|9.132||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.132|2.339|<0.0001
91639362|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-0.057||||0.0026||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0026
91639363|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-0.85||||0.0032||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0032
91639364|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-0.58||||0.0125||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0125
91639365|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-0.75|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
91639366|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-0.57|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
91639367|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-8.97|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
91639368|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-8.15|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
91639369|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-7.17||||0.0265||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0265
91639370|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-6.85||||0.0084||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0084
91639371|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-8.36|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
91639372|NCT00151775|183170477|SUPERIORITY_OR_OTHER||Slope|-7.71|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
91639373|NCT00151775|183170478|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.58||||0.0093|TWO_SIDED|95.0|-6.27|-0.89|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||-0.89|-6.27|0.0093
91639374|NCT00151775|183170478|SUPERIORITY_OR_OTHER||LS Mean difference|-3.49||||0.0052|TWO_SIDED|95.0|-5.92|-1.05|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||-1.05|-5.92|0.0052
91639375|NCT00151775|183170478|SUPERIORITY_OR_OTHER||LS Mean difference|-2.57||||0.133|TWO_SIDED|95.0|-5.93|0.79|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||0.79|-5.93|0.1330
91639376|NCT00151775|183170478|SUPERIORITY_OR_OTHER||LS Mean difference|-1.38||||0.3442|TWO_SIDED|95.0|-4.27|1.5|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||1.50|-4.27|0.3442
91639377|NCT00151775|183170478|SUPERIORITY_OR_OTHER||LS Mean difference|-3.16||||0.0029|TWO_SIDED|95.0|-5.24|-1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested||-1.09|-5.24|0.0029
91639378|NCT00151775|183170478|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8||||0.0032|TWO_SIDED|95.0|-4.65|-0.95|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||-0.95|-4.65|0.0032
91639379|NCT00151775|183170479|SUPERIORITY_OR_OTHER||LS Mean difference|-2.82||||0.2113|TWO_SIDED|95.0|-7.29|1.65|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested.||1.65|-7.29|0.2113
91639380|NCT00151775|183170479|SUPERIORITY_OR_OTHER||LS Mean difference|-2.92||||0.1496|TWO_SIDED|95.0|-6.92|1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||1.09|-6.92|0.1496
91672919|NCT02985879|183240718|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.88|=|0.104|TWO_SIDED|95.0|-0.3|3.16|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.16|-0.30|=0.104
91672920|NCT02985879|183240719|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16|=|0.756|TWO_SIDED|95.0|-0.36|0.26|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.26|-0.36|=0.756
91672921|NCT02985879|183240719|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16|=|0.409|TWO_SIDED|95.0|-0.44|0.18|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.18|-0.44|=0.409
91672922|NCT02985879|183240720|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|13.54|=|0.597|TWO_SIDED|95.0|-33.86|19.53|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||19.53|-33.86|=0.597
91672923|NCT02985879|183240720|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|13.56|=|0.642|TWO_SIDED|95.0|-33.04|20.42|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||20.42|-33.04|=0.642
91672924|NCT02985879|183240721|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.53|=|0.323|TWO_SIDED|95.0|-2.48|7.51|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||7.51|-2.48|=0.323
91672925|NCT02985879|183240721|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.51|=|0.974|TWO_SIDED|95.0|-4.86|5.02|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.02|-4.86|=0.974
91672926|NCT02985879|183240726|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.761|TWO_SIDED|95.0|-0.31|0.23|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.23|-0.31|=0.761
91672927|NCT02985879|183240726|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13|=|0.678|TWO_SIDED|95.0|-0.32|0.21|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.21|-0.32|=0.678
91672928|NCT02985879|183240727|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.653|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||5.57|-3.50|=0.653
91715959|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.919||||0.6941|TWO_SIDED|95.0|0.602|1.402|||Regression, Logistic|||"Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate logistic regression model for PFS6"||1.402|0.602|0.6941
91715960|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.744||||0.134|TWO_SIDED|95.0|0.506|1.095|||Regression, Logistic|||"Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).~nRCBV was modeled with a univariate logistic regression model for PFS6."||1.095|0.506|0.1340
91526443|NCT03500640|182928050|SUPERIORITY|||||||0.081||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.081
91526444|NCT03500640|182928051|SUPERIORITY|||||||0.712||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.712
91715961|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.821||||0.2642|TWO_SIDED|95.0|0.58|1.161|||Regression, Logistic|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.~nCBF was modeled with a univariate logistic regression model for PFS6."||1.161|0.580|0.2642
91639381|NCT02706327|183170514|OTHER||||||<|0.001||||||A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.|Kruskal-Wallis|Effect sizes (Cohen's d) were calculated for significant differences.||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.||||<0.001
91672929|NCT02985879|183240727|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.748|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.57|-3.50|=0.748
91672930|NCT02985879|183240728|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34|=|0.828|TWO_SIDED|95.0|-0.6|0.74|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.74|-0.60|=0.828
91672931|NCT02985879|183240728|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34|=|0.543|TWO_SIDED|95.0|-0.46|0.87|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.87|-0.46|=0.543
91672932|NCT02985879|183240729|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|25.44|=|0.829|TWO_SIDED|95.0|-55.66|44.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||44.63|-55.66|=0.829
91672933|NCT02985879|183240729|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|25.92|=|0.206|TWO_SIDED|95.0|-83.94|18.23|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||18.23|-83.94|=0.206
91639382|NCT02706327|183170515|OTHER|||||||0.547|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.547
91639383|NCT02706327|183170516|OTHER|||||||0.895|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.895
91715962|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.855||||0.5069|TWO_SIDED|95.0|0.539|1.357|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6||1.357|0.539|0.5069
91715963|NCT00902577|183322671|OTHER||Odds Ratio (OR)|0.884||||0.1921|TWO_SIDED|95.0|0.735|1.064|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6||1.064|0.735|0.1921
91715964|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.61|||||TWO_SIDED|95.0|0.42|0.79||||||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.79|0.42|
91715965|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.59|||||TWO_SIDED|95.0|0.39|0.78||||||"T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.78|0.39|
91639384|NCT02706327|183170517|OTHER|||||||0.842|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.842
91639385|NCT02706327|183170518|OTHER|||||||0.848|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.848
91672934|NCT02985879|183240730|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.88|=|0.304|TWO_SIDED|95.0|-3.65|11.65|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||11.65|-3.65|=0.304
91672935|NCT02985879|183240730|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|3.88|=|0.243|TWO_SIDED|95.0|-3.11|12.19|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||12.19|-3.11|=0.243
91672936|NCT02985879|183240731|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|53.86||0.625|TWO_SIDED|95.0|-132.76|79.94|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||79.94|-132.76|0.625
91672937|NCT02985879|183240731|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|33.2|STANDARD_ERROR_OF_MEAN|55.47|=|0.55|TWO_SIDED|95.0|-76.34|142.71|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||142.71|-76.34|=0.550
91672938|NCT02985879|183240732|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1739.1|STANDARD_ERROR_OF_MEAN|2502.95|=|0.488|TWO_SIDED|95.0|-3201.75|6680.02|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||6680.02|-3201.75|=0.488
91672939|NCT02985879|183240732|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|3684.9|STANDARD_ERROR_OF_MEAN|2487.32|=|0.14|TWO_SIDED|95.0|-1225.46|8595.29|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||8595.29|-1225.46|=0.140
91672940|NCT02985879|183240733|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|207.9|STANDARD_ERROR_OF_MEAN|592.68|=|0.726|TWO_SIDED|95.0|-962.98|1378.88|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1378.88|-962.98|=0.726
91672941|NCT02985879|183240733|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|133.6|STANDARD_ERROR_OF_MEAN|611.91|=|0.828|TWO_SIDED|95.0|-1075.26|1342.4|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||1342.40|-1075.26|=0.828
91715966|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.46|0.83||||||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.83|0.46|
91715967|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.62|||||TWO_SIDED|95.0|0.42|0.83||||||"mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9."||0.83|0.42|
91672942|NCT00380692|183240830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.0|-3.4||P-value for treatment group differences over time.|Mixed Models Analysis|||||-3.4|-10.0|<0.001
91672943|NCT00380692|183240831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.921||95.0|-0.5|0.4||P-value for treatment differences over time.|Mixed Models Analysis|||||0.4|-0.5|0.921
91672944|NCT00380692|183240832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.369||95.0|-1.8|0.7||P-value for treatment differences in Oppositional Score at 8 weeks.|ANCOVA|||||0.7|-1.8|0.369
91672945|NCT00380692|183240832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.024||95.0|-3.7|-0.3||P-value for treatment differences in Hyperactivity score at 8 weeks|ANCOVA|||||-0.3|-3.7|0.024
91672946|NCT00380692|183240832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.51||0.179||95.0|-1.7|0.3||P-value for treatment differences in Cognititve/Attention score at 8 weeks.|ANCOVA|||||0.3|-1.7|0.179
91672947|NCT00380692|183240832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.48||0.077||95.0|-5.6|0.3||P-value for treatment differences in ADHD score at 8 weeks|ANCOVA|||||0.3|-5.6|0.077
91672948|NCT00380692|183240834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028||95.0|-1.0|-0.1||P-value for treatment differences in Time to fall asleep score at 8 weeks.|ANCOVA|||||-0.1|-1.0|0.028
91672949|NCT00380692|183240834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.407||95.0|-0.3|0.9||P-value for treatment differences in Difficulty falling asleep score at 8 weeks.|ANCOVA|||||0.9|-0.3|0.407
91672950|NCT00380692|183240834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.652||95.0|-0.6|0.4||P-value for treatment differences in Total hours of sleep score at 8 weeks.|ANCOVA|||||0.4|-0.6|0.652
91672951|NCT00380692|183240834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.49||0.112||95.0|-1.7|0.2||P-value for treatment differences in Quality of sleep score at 8 weeks.|ANCOVA|||||0.2|-1.7|0.112
91715968|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.44|0.84||||||"Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9."||0.84|0.44|
91672952|NCT00380692|183240834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.87||0.188||95.0|-2.9|0.6||P-value for treatment differences in Functional outcome during day score at 8 weeks.|ANCOVA|||||0.6|-2.9|0.188
91672953|NCT00380692|183240835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|1.29||0.452||95.0|-3.5|1.6||P-value for treatment differences in Irritability score at 8 weeks.|ANCOVA|||||1.6|-3.5|0.452
91672954|NCT00380692|183240835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|1.1||0.85||95.0|-2.4|2.0||P-value for treatment differences in Lethargy score at 8 weeks.|ANCOVA|||||2.0|-2.4|0.850
91672955|NCT00380692|183240835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.63||0.014||95.0|-2.8|-0.3||P-value for treatment differences in Stereotypic score at 8 weeks.|ANCOVA|||||-0.3|-2.8|0.014
91672956|NCT00380692|183240835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.68||0.01||95.0|-7.8|-1.1||P-value for treatment differences in Hyperactivity score at 8 weeks.|ANCOVA|||||-1.1|-7.8|0.010
91672957|NCT00380692|183240835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.045||95.0|-1.7|0.0||P-value for treatment differences in Inappropriate speech score at 8 weeks.|ANCOVA|||||-0.0|-1.7|0.045
91672958|NCT00380692|183240836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|2.13||0.069||95.0|-8.1|0.3||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.3|-8.1|0.069
91672959|NCT00380692|183240837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.598||95.0|-1.6|0.9||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.9|-1.6|0.598
91672960|NCT00380692|183240838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|STANDARD_ERROR_OF_MEAN|11.12||0.318||95.0|-33.3|11.0||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||11.0|-33.3|0.318
91715969|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.54|0.89||||||nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.54|
91715970|NCT00902577|183322671|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.55|0.89||||||nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.55|
91715971|NCT04456686|183322708|SUPERIORITY||Posterior Mean Difference|-0.03|||||TWO_SIDED|95.0|-0.77|0.7|||Bayesian Mixed Model Analysis|||||0.70|-0.77|
91715972|NCT04456686|183322709|SUPERIORITY||Posterior Mean Difference|0.58|||||TWO_SIDED|95.0|-0.82|1.96|||Bayesian Mixed Model Analysis|||||1.96|-0.82|
91672961|NCT00380692|183240839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.7||0.948||95.0|-5.5|5.2||P-value for treatment differences in Error Rate over time.|Mixed Models Analysis|||||5.2|-5.5|0.948
91672962|NCT00380692|183240839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.5||0.399||95.0|-9.7|3.9||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||3.9|-9.7|0.399
91672963|NCT00380692|183240839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_DEVIATION|3.1||0.57||95.0|-4.3|7.8||P-value for Treatment\*Condition Error Rate relevant nontargets over time.|Mixed Models Analysis|||||7.8|-4.3|0.570
91672964|NCT00380692|183240840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.9|STANDARD_ERROR_OF_MEAN|66.0||0.352||95.0|-193.5|69.8||P-value for Treatment differences in Reaction time over time.|Mixed Models Analysis|||||69.8|-193.5|0.352
91672965|NCT00380692|183240840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.1|STANDARD_ERROR_OF_MEAN|62.3||0.553||95.0|-160.3|86.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections irrelevant target over time.|Mixed Models Analysis|||||86.2|-160.3|0.553
91672966|NCT00380692|183240840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_ERROR_OF_MEAN|57.7||0.904||95.0|-107.1|121.1||P-value for Treatment\*Condition Mean Reaction Time correct rejections relevant nontarget over time.|Mixed Models Analysis|||||121.1|-107.1|0.904
91672967|NCT00380692|183240841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|65.9||0.748||95.0|-152.8|110.3||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||110.3|-152.8|0.748
91715973|NCT04456686|183322710|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.45|0.63|||Bayesian Mixed Model Analysis|||||0.63|-0.45|
91715974|NCT04456686|183322711|SUPERIORITY||Posterior Mean Difference|0.9|||||TWO_SIDED|95.0|-3.31|5.06|||Bayesian Mixed Model Analysis|||||5.06|-3.31|
91715975|NCT04456686|183322712|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.46|0.5|||Bayesian Mixed Model Analysis|||||0.50|-0.46|
91639386|NCT04579666|183170519|SUPERIORITY||Difference in LS Mean|-3.0||||0.7205|TWO_SIDED|95.0|-19.5|13.5|||ANCOVA|||Analysis of covariance (ANCOVA) was used to analyze the ranks of the CAFS score with treatment as a fixed effect, adjusted for baseline ALSFRS-R total score, time from symptom onset, baseline Log neurofilament light chain (NfL), and the randomization stratification factors (location of first muscle weakness and use of riluzole and edaravone).||13.5|-19.5|0.7205
91639387|NCT04579666|183170524|SUPERIORITY||Difference in LS Mean|-0.7||||0.6447|TWO_SIDED|95.0|-3.5|2.2|||MMRM|||The mixed-effect model for repeated measures (MMRM) included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors location of first muscle weakness and use of riluzole and/or edaravone).||2.2|-3.5|0.6447
91639388|NCT04579666|183170525|SUPERIORITY||Difference in LS Mean|-6.6||||0.0949|TWO_SIDED|95.0|-14.3|1.2|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||1.2|-14.3|0.0949
91639389|NCT04579666|183170526|SUPERIORITY||Difference in LS Mean|-0.19||||0.0935|TWO_SIDED|95.0|-0.42|0.03|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||0.03|-0.42|0.0935
91639390|NCT04579666|183170528|SUPERIORITY||Difference in LS Mean|6.5||||0.0069|TWO_SIDED|95.0|1.8|11.1|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||11.1|1.8|0.0069
91639391|NCT01982942|183170545|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||The null hypothesis states that the BPF rates of change in the treatment and placebo groups are equal, which can be evaluated based on as assessment of parameter estimates from a linear mixed model (LMM).||||0.04
91639392|NCT01224171|183170554|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4332|TWO_SIDED|95.0|-4.5|10.5|||Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine \[6-MP\], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.||10.5|-4.5|0.4332
91639393|NCT01270139|183170581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
91639394|NCT01270139|183170582|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
91639395|NCT01270139|183170583|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
91639396|NCT01270139|183170584|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
91639397|NCT01270139|183170585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
91639398|NCT01270139|183170586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
91715976|NCT04456686|183322713|SUPERIORITY||Posterior Mean Difference|0.11|||||TWO_SIDED|95.0|-0.72|0.91|||Bayesian Mixed Model Analysis|||||0.91|-0.72|
91715977|NCT04456686|183322714|SUPERIORITY||Posterior Mean Difference|2.45|||||TWO_SIDED|95.0|-7.27|12.2|||Bayesian Mixed Model Analysis|||||12.20|-7.27|
91715978|NCT04456686|183322715|SUPERIORITY||Posterior Mean Difference|0.4|||||TWO_SIDED|95.0|-0.04|0.85|||Bayesian Mixed Model Analysis|||||0.85|-0.04|
91715979|NCT04456686|183322716|SUPERIORITY||Posterior Mean Difference|168.61|||||TWO_SIDED|95.0|-38.22|379.2|||Bayesian Mixed Model Analysis|||||379.20|-38.22|
91715980|NCT04456686|183322717|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.06|||Bayesian Mixed Model Analysis|||||0.06|-0.07|
91715981|NCT02059239|183322729|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|88.9|||||TWO_SIDED|95.0|65.3|98.6||||||||98.6|65.3|
91639399|NCT01270139|183170587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
91639400|NCT01270139|183170588|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
91639401|NCT01270139|183170589|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Chi-squared|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
91639402|NCT01270139|183170590|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
91639403|NCT01270139|183170591|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
91639404|NCT01270139|183170592|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
91639405|NCT01270139|183170593|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
91639406|NCT01270139|183170594|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
91639407|NCT01270139|183170595|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
91639408|NCT01270139|183170596|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
91672968|NCT00380692|183240841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-80.9|STANDARD_ERROR_OF_MEAN|77.5||0.299||95.0|-234.3|72.5||P-value for Treatment\*Condition Standard Deviation correct rejections irrelevant target over time.|Mixed Models Analysis|||||72.5|-234.3|0.299
91672969|NCT00380692|183240841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_ERROR_OF_MEAN|67.1||0.84||95.0|-119.3|146.5||P-value for Treatment\*Condition Standard Deviation correct rejections relevant nontarget over time.|Mixed Models Analysis|||||146.5|-119.3|0.840
91715982|NCT02059239|183322729|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|95.9||||||||95.9|54.4|
91715983|NCT02059239|183322730|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
91639409|NCT01270139|183170597|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
91639410|NCT01270139|183170598|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|t-test, 2 sided|||Null hypothesis is ex-vivo arm with exposure of nanoparticles is superior to saline control.||||<0.05
91639411|NCT04140942|183170608|SUPERIORITY|||||||0.15|||||||Chi-squared|||6-Month Employment||||.15
91639412|NCT04140942|183170608|SUPERIORITY|||||||0.001|||||||Regression, Logistic|||6-Month Employment||||.001
91639413|NCT04140942|183170608|SUPERIORITY|||||||0.87|||||||Chi-squared|||12-Month Employment||||.87
91639414|NCT04140942|183170609|SUPERIORITY|||||||0.04|||||||ANCOVA|Repeated measures.||||||0.04
91639415|NCT04140942|183170610|SUPERIORITY|||||||0.056|||||||Chi-squared|||12-Month Recidivism Analysis||||.056
91639416|NCT04140942|183170610|SUPERIORITY|||||||0.18|||||||Chi-squared|||6-Month Recidivism Analysis||||.18
91639417|NCT02918968|183170632|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.29|0.61||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||0.61|0.29|<0.001
91639418|NCT02918968|183170634|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|37.8|||<|0.001|TWO_SIDED|95.0|25.2|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|\>=50% reduction||50.4|25.2|<0.001
91639419|NCT02918968|183170634|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|38.4|||<|0.001|TWO_SIDED|95.0|26.3|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥ 90% reduction||50.4|26.3|<0.001
91639420|NCT02918968|183170635|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|40.7|||<|0.001|TWO_SIDED|95.0|28.3|53.1||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|≥ 50% reduction||53.1|28.3|<0.001
91639421|NCT02918968|183170635|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|33.5|||<|0.001|TWO_SIDED|95.0|21.5|45.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥90% reduction||45.4|21.5|<0.001
91639422|NCT02918968|183170636|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
91639423|NCT02918968|183170637|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
91639424|NCT02918968|183170639|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.67||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1)|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||1.67|0.45|0.669
91639425|NCT00750061|183170640|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (wk6-d0)||||0.343
91639426|NCT00750061|183170640|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (m6-d0)||||0.69
91639427|NCT00750061|183170640|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (wk6-d0)||||1
91639428|NCT00750061|183170640|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (m6-d0)||||0.32
91639429|NCT00750061|183170640|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (wk6-d0)||||1
91639430|NCT00750061|183170640|SUPERIORITY_OR_OTHER|||||||0.582|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (m6-d0)||||0.582
91639431|NCT00750061|183170641|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (Wk6 - D0)||||0.257
91639432|NCT00750061|183170641|SUPERIORITY_OR_OTHER|||||||0.168|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (M6 - D0)||||0.168
91639433|NCT00750061|183170641|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (Wk6 - D0)||||0.013
91639434|NCT00750061|183170641|SUPERIORITY_OR_OTHER|||||||0.137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (M6 - D0)||||0.137
91639435|NCT01374516|183170649|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|60.8|||||TWO_SIDED|95.0|52.0|68.0||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||68.0|52.0|
91639436|NCT01374516|183170650|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.8||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.8|58.7|
91639437|NCT01374516|183170651|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.9||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.9|58.7|
91672970|NCT00380692|183240842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.8||0.126||95.0|-1.2|9.9||P-value for Treatment differences in Error Rate over time.|Mixed Models Analysis|||||9.9|-1.2|0.126
91672971|NCT00380692|183240842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.7||0.297||95.0|-5.2|1.6||P-value for Treatment\*Error Rate absent over time.|Mixed Models Analysis|||||1.6|-5.2|0.297
91672972|NCT00380692|183240842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|2.1||0.023||95.0|-9.4|-0.7||P-value for Treatment\*Targets Load 1 over time.|Mixed Models Analysis|||||-0.7|-9.4|0.023
91672973|NCT00380692|183240843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.2|STANDARD_ERROR_OF_MEAN|71.7||0.228||95.0|-230.4|56.0||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||56.0|-230.4|0.228
91672974|NCT00380692|183240843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.6|STANDARD_ERROR_OF_MEAN|77.3||0.26||95.0|-65.6|240.8||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 1 over time.|Mixed Models Analysis|||||240.8|-65.6|0.260
91672975|NCT00380692|183240843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|70.4|STANDARD_ERROR_OF_MEAN|59.5||0.239||95.0|-47.3|188.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||188.2|-47.3|0.239
91672976|NCT00380692|183240843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.7|STANDARD_ERROR_OF_MEAN|80.1||0.128||95.0|-35.9|281.4||P-value for Treatment\*Condition Mean Reaction Time hits Load 1 over time.|Mixed Models Analysis|||||281.4|-35.9|0.128
91672977|NCT00380692|183240844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-175.5|STANDARD_ERROR_OF_MEAN|88.0||0.051||95.0|-351.5|0.5||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||0.5|-351.5|0.051
91672978|NCT00380692|183240844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|218.1|STANDARD_ERROR_OF_MEAN|90.8||0.018||95.0|38.0|398.2||P-value for Treatment\*Condition Standard Deviation correct rejections Load 1 over time.|Mixed Models Analysis|||||398.2|38.0|0.018
91715984|NCT02059239|183322730|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|75.3|100.0||||||||100.0|75.3|
91715985|NCT02059239|183322731|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
91715986|NCT02059239|183322731|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|92.3|||||TWO_SIDED|95.0|64.0|99.8||||||||99.8|64.0|
91672979|NCT00380692|183240844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|173.6|STANDARD_ERROR_OF_MEAN|105.6||0.103||95.0|-35.7|383.0||P-value for Treatment\*Condition Standard Deviation correct rejections Load 2 over time.|Mixed Models Analysis|||||383.0|-35.7|0.103
91672980|NCT00380692|183240844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|205.5|STANDARD_ERROR_OF_MEAN|99.9||0.042||95.0|7.5|403.6||P-value for Treatment\*Condition Standard Deviation hits Load 1 over time.|Mixed Models Analysis|||||403.6|7.5|0.042
91672981|NCT00380692|183240845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|STANDARD_ERROR_OF_MEAN|4.6||0.128||95.0|-16.9|2.3||P-value for Treatment difference in Accuracy over time.|Mixed Models Analysis|||||2.3|-16.9|0.128
91672982|NCT00380692|183240846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.4||0.022||95.0|-11.2|-1.0||P-value for Treatment difference in Stability of Movement over time.|Mixed Models Analysis|||||-1.0|-11.2|0.022
91672983|NCT00380692|183240847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.0||0.43||95.0|-2.4|5.7||P-value for Treatment difference in Error Rate over time.|Mixed Models Analysis|||||5.7|-2.4|0.430
91672984|NCT00380692|183240847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0|STANDARD_ERROR_OF_MEAN|2.4||0.005||95.0|-11.8|-2.2||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||-2.2|-11.8|0.005
91672985|NCT00380692|183240848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.9||0.221||95.0|-9.6|2.3||P-value for Treatment differences in Error Rates over time.|Mixed Models Analysis|||||2.3|-9.6|0.221
91672986|NCT00380692|183240848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.0||0.307||95.0|-2.1|6.3||P-value for Treatment\*Condition Error Rates compatible signals over time.|Mixed Models Analysis|||||6.3|-2.1|0.307
91672987|NCT00380692|183240849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|68.9||0.752||95.0|-163.1|119.1||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||119.1|-163.1|0.752
91672988|NCT00380692|183240849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.6|STANDARD_ERROR_OF_MEAN|31.9||0.564||95.0|-47.0|84.3||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||84.3|-47.0|0.564
91672989|NCT02065713|183240908|SUPERIORITY||||||=|0.026|||||||Wilcoxon (Mann-Whitney)|||||||=0.026
91672990|NCT02062801|183240916|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Chi-squared|||||||0.18
91672991|NCT02062801|183240917|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
91672992|NCT02062801|183240918|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared|||||||.56
91715987|NCT02059239|183322732|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
91715988|NCT02059239|183322732|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|84.6|||||TWO_SIDED|95.0|54.6|98.1||||||||98.1|54.6|
91715989|NCT02059239|183322733|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
91672993|NCT03923699|183240948|SUPERIORITY||Risk Ratio (RR)|0.96||||0.41|TWO_SIDED|95.0|0.85|1.08||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.08|0.85|0.41
91672994|NCT03923699|183240949|SUPERIORITY||Risk Ratio (RR)|1.0||||0.92|TWO_SIDED|95.0|0.92|1.1||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.10|0.92|0.92
91672995|NCT03923699|183240950|SUPERIORITY||Risk Ratio (RR)|0.98||||0.68|TWO_SIDED|95.0|0.89|1.09||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.09|0.89|0.68
91672996|NCT03923699|183240951|SUPERIORITY||Risk Ratio (RR)|0.98||||0.42|TWO_SIDED|95.0|0.92|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.92|0.42
91672997|NCT03923699|183240952|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.99
91672998|NCT03923699|183240953|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.95|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.95|0.95
91672999|NCT03923699|183240954|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.29|TWO_SIDED|95.0|0.0|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.00|0.29
91673000|NCT03923699|183240955|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.37|TWO_SIDED|95.0|-0.01|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.01|0.37
91715990|NCT02059239|183322733|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|19.2|74.9||||||||74.9|19.2|
91715991|NCT02059239|183322734|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0.0|
91673001|NCT03923699|183240956|SUPERIORITY||Risk Ratio (RR)|1.03||||0.3|TWO_SIDED|95.0|0.95|1.13||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.13|0.95|0.30
91673002|NCT03923699|183240957|SUPERIORITY||Risk Ratio (RR)|1.0||||0.85|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.85
91673003|NCT03923699|183240958|SUPERIORITY||Risk Ratio (RR)|0.99||||0.51|TWO_SIDED|95.0|0.97|1.02||Not adjusted for multiple comparisons.|Regression, poisson|||||1.02|0.97|0.51
91673004|NCT04578886|183240959|SUPERIORITY||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|3.7||0.22|TWO_SIDED|95.0|2.3|4.4|||t-test, 2 sided|||||4.4|2.3|0.22
91673005|NCT04578886|183240959|SUPERIORITY||Risk Ratio (RR)|1.3307||||0.015|TWO_SIDED|95.0|1.0571|1.6751||unadjusted for covariates|Regression, Linear|||"Null Hypothesis: The administration of guanfacine in critically ill patients in the intensive unit has no effect on the duration of delirium.~Continuous variables will be summarized using sample mean and sample variance whereas categorical variables will be summarized as proportions. Logistic regression models will examine whether age, gender, or comorbities associated with incidence of delirium when Guanfacine is administered."||1.6751|1.0571|0.0150
91673006|NCT00296491|183240998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_ERROR_OF_MEAN|5.41|<|0.001||95.0|12.5|33.8|||t-test, 2 sided||Treatment Difference = FSC - MON|||33.8|12.5|<0.001
91673007|NCT00296491|183240999|NON_INFERIORITY_OR_EQUIVALENCE|Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance.|Mean Difference (Net)|-8.9|STANDARD_ERROR_OF_MEAN|8.0|<|0.127||95.0|-24.6|6.9|||t-test, 2 sided||Treatment Difference=FSC+MON-FSC|||6.9|-24.6|<0.127
91673008|NCT03347838|183241008|SUPERIORITY||Observed response rate|0.526||||0.03|TWO_SIDED|95.0|0.32|1.0|||Fisher Exact|||The null hypothesis is that the 6-month response rate is less than or equal to 0.3.||1|0.32|0.03
91673009|NCT00484419|183241027|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0061
91673010|NCT00484419|183241027|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.1090
91673011|NCT00484419|183241027|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
91673012|NCT00484419|183241028|SUPERIORITY_OR_OTHER|||||||0.0234||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0234
91673013|NCT00484419|183241028|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
91673014|NCT00484419|183241028|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0011
91715992|NCT02059239|183322734|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|15.4|||||TWO_SIDED|95.0|1.9|45.4||||||||45.4|1.9|
91715993|NCT02059239|183322735|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|66.7|||||TWO_SIDED|95.0|41.0|86.7||||||||86.7|41.0|
91715994|NCT02059239|183322735|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|43.8|||||TWO_SIDED|95.0|19.8|70.1||||||||70.1|19.8|
91715995|NCT02059239|183322736|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|87.5|||||TWO_SIDED|95.0|61.7|98.4||||||||98.4|61.7|
91715996|NCT02059239|183322736|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|76.9|||||TWO_SIDED|95.0|46.2|95.0||||||||95.0|46.2|
91639438|NCT01374516|183170652|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|61.9|||||TWO_SIDED|95.0|54.7|68.0||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||68.0|54.7|
91673015|NCT00484419|183241031|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0077
91673016|NCT00484419|183241031|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
91673017|NCT00484419|183241031|SUPERIORITY_OR_OTHER|||||||0.0483||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0483
91673018|NCT00484419|183241032|SUPERIORITY_OR_OTHER|||||||0.0133||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0133
91673019|NCT00484419|183241032|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
91673020|NCT00484419|183241032|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0125
91673021|NCT00484419|183241035|SUPERIORITY_OR_OTHER|||||||0.8596||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.8596
91673022|NCT00484419|183241035|SUPERIORITY_OR_OTHER|||||||0.0257||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0257
91673023|NCT00484419|183241035|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1862
91673024|NCT00484419|183241036|SUPERIORITY_OR_OTHER|||||||0.7094||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.7094
91715997|NCT02059239|183322737|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|96.0||||||||96.0|54.4|
91673025|NCT00484419|183241036|SUPERIORITY_OR_OTHER|||||||0.1394||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1394
91673026|NCT00484419|183241036|SUPERIORITY_OR_OTHER|||||||0.4528||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.4528
91673027|NCT00484419|183241038|SUPERIORITY_OR_OTHER|||||||0.0374||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0374
91673028|NCT00484419|183241038|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
91639439|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|18.332||0.6241|TWO_SIDED|95.0|-31.05|42.71||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||42.71|-31.05|0.6241
91673029|NCT00484419|183241038|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0001
91673030|NCT00484419|183241039|SUPERIORITY_OR_OTHER|||||||0.2701||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2701
91673031|NCT00484419|183241039|SUPERIORITY_OR_OTHER|||||||0.6117||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.6117
91673032|NCT00484419|183241039|SUPERIORITY_OR_OTHER|||||||0.2007||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2007
91673033|NCT00484419|183241041|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
91673034|NCT00484419|183241041|SUPERIORITY_OR_OTHER|||||||0.1864||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1864
91673035|NCT00484419|183241041|SUPERIORITY_OR_OTHER|||||||0.0999||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0999
91673036|NCT00484419|183241042|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
91673037|NCT00484419|183241042|SUPERIORITY_OR_OTHER|||||||0.0566||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0566
91673038|NCT00484419|183241042|SUPERIORITY_OR_OTHER|||||||0.0217||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0217
91673039|NCT02462486|183241082|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-5.0|2.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||2.4|-5.0|
91673040|NCT02462486|183241082|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-4.6|||||TWO_SIDED|95.0|-9.0|-0.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||-0.5|-9.0|
91715998|NCT02059239|183322737|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|30.8|||||TWO_SIDED|95.0|9.1|61.4||||||||61.4|9.1|
91715999|NCT02059239|183322738|OTHER|Median PFS in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Median (95% CI)|8.0|||||TWO_SIDED|95.0|5.0|25.0||||||||25|5|
91673041|NCT02462486|183241083|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-2.4|2.0|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||2.0|-2.4|
91673042|NCT02462486|183241083|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-3.8|0.6|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||0.6|-3.8|
91673043|NCT02462486|183241084|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-7.1|14.0|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||14.0|-7.1|
91673044|NCT02462486|183241084|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-4.7|16.5|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||16.5|-4.7|
91673045|NCT02462486|183241085|SUPERIORITY||Percentage Difference|1.4|||||TWO_SIDED|95.0|-5.5|8.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||8.4|-5.5|
91673046|NCT02462486|183241085|SUPERIORITY||Percentage Difference|-2.3|||||TWO_SIDED|95.0|-9.1|4.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||4.5|-9.1|
91673047|NCT02462486|183241086|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.5|0.3|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||0.3|-3.5|
91673048|NCT02462486|183241086|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.9|-0.1|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||-0.1|-3.9|
91673049|NCT04706507|183241087|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||The null hypothesis is that there is no significant difference in the number of respiratory support free days between the active drug arm and the placebo drug arm based on the student's t-test.||||0.098
91673050|NCT04706507|183241088|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
91673051|NCT04706507|183241089|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||The null hypothesis is that there is no significant difference in the number of respiratory support free days between the active drug arm and the placebo drug arm based on the student's t-test.||||0.130
91673052|NCT04706507|183241090|SUPERIORITY||Hazard Ratio (HR)|2.65||||0.003|TWO_SIDED|95.0|1.4|5.02|||Regression, Cox||The placebo arm is the comparison arm (denominator). The incidence rate uses the person-years at risk for each of the study arms.|The null hypothesis is that there is no difference between the two arms. The placebo arm is the comparison group.||5.02|1.40|0.003
91673053|NCT04706507|183241091|SUPERIORITY||Hazard Ratio (HR)|2.21||||0.002|TWO_SIDED|95.0|1.32|3.68|||Regression, Cox||The placebo arm is the comparison arm (denominator). The incidence rate uses the person-years at risk for each of the study arms.|the null hypothesis is that there is no difference between the two arms. The placebo group is the comparator group.||3.68|1.32|0.002
91673054|NCT04706507|183241092|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||||||0.83
91673055|NCT04706507|183241093|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||||||0.457
91673056|NCT04706507|183241095|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||The null hypothesis is that there is no significant difference in the number of ICU free days between the active drug arm and the placebo drug arm based on the student's t-test.||||0.037
91673057|NCT04706507|183241096|SUPERIORITY||||||<|0.001||||||This analysis evaluated any level of CMV reactivation.|Fine-Gray competing risks regression|This analysis will include death as a competing risk if it occurs on the same day of the last negative CMV test date.||||||<0.001
91673058|NCT04706507|183241096|SUPERIORITY|||||||0.3||||||This analysis evaluate CMV reactivation \> 1000 UI/mL.|Fine-Gray competing risks regression|This analysis will include death as a competing risk if it occurs on the same day of the last negative CMV test date.||||||0.3
91673059|NCT00285584|183241113|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.5||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
91673060|NCT00285584|183241114|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.5||||0.3|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank test||||0.3
91673061|NCT00285584|183241115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.15||||0.3|TWO_SIDED|95.0|0.4|27.8|||Fisher Exact|||Comparison of cumulative incidence proportions||27.8|0.4|0.3
91673062|NCT00285584|183241116|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.5||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91673063|NCT01523587|183241135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.814||||0.0103|TWO_SIDED|95.0|0.693|0.956||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.||0.956|0.693|0.0103
91716000|NCT01039467|183322755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91716001|NCT01039467|183322756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91526445|NCT03500640|182928052|SUPERIORITY|||||||0.371||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.371
91716002|NCT01039467|183322757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.833
91526446|NCT03500640|182928053|SUPERIORITY|||||||0.801||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.801
91639440|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|11.87|STANDARD_ERROR_OF_MEAN|19.081||0.7315|TWO_SIDED|95.0|-26.52|50.26||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||50.26|-26.52|0.7315
91639441|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|18.566||0.6212|TWO_SIDED|95.0|-31.65|43.18||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||43.18|-31.65|0.6212
91639442|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|20.662||0.5987|TWO_SIDED|95.0|-36.44|46.84||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||46.84|-36.44|0.5987
91639443|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Median Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|18.114||0.482|TWO_SIDED|95.0|-37.28|35.64||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||35.64|-37.28|0.4820
91639444|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|19.9|STANDARD_ERROR_OF_MEAN|18.496||0.8562|TWO_SIDED|95.0|-17.33|57.13||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||57.13|-17.33|0.8562
91639445|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|18.3||0.488|TWO_SIDED|95.0|-37.46|36.35||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||36.35|-37.46|0.4880
91639446|NCT00612456|183170797|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|20.008||0.7556|TWO_SIDED|95.0|-26.38|54.32||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||54.32|-26.38|0.7556
91639447|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|1.29||0.0015|TWO_SIDED|95.0|1.74|6.91|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.91|1.74|0.0015
91639448|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|1.403||0.5921|TWO_SIDED|95.0|-2.05|3.57|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.57|-2.05|0.5921
91639449|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.988||0.9646|TWO_SIDED|95.0|-3.89|4.07|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.07|-3.89|0.9646
91639450|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|4.75||||0.0003|TWO_SIDED|95.0|2.32|7.19|||ANCOVA|||Comparison between Baseline value and Day 29 value.||7.19|2.32|0.0003
91639451|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.326||0.2208|TWO_SIDED|95.0|-1.02|4.3|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.30|-1.02|0.2208
91639452|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.927||0.9847|TWO_SIDED|95.0|-3.9|3.83|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.83|-3.90|0.9847
91716003|NCT01039467|183322758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.265
91716004|NCT01039467|183322759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91716005|NCT01039467|183322760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91716006|NCT01039467|183322761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
91716007|NCT01039467|183322762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.053
91716008|NCT01039467|183322763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.493
91673064|NCT01523587|183241136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.0193|TWO_SIDED|95.0|0.727|0.973||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.||0.973|0.727|0.0193
91673065|NCT01523587|183241137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.0551|TWO_SIDED|95.0|0.98|4.32||Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.|Regression, Logistic|||||4.32|0.98|0.0551
91673066|NCT01523587|183241138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002|TWO_SIDED|95.0|1.18|2.06|||Regression, Logistic|Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.||||2.06|1.18|0.0020
91673067|NCT01523587|183241139|SUPERIORITY_OR_OTHER||Adjusted mean|-1.2|STANDARD_ERROR_OF_MEAN|1.77||0.5|TWO_SIDED|95.0|-4.67|2.28|||ANCOVA||Mean was adjusted for baseline sum of diameters and race.|The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.||2.28|-4.67|0.500
91673068|NCT01523587|183241141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2562|TWO_SIDED|95.0|0.72|1.09||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Coughing.||1.09|0.72|0.2562
91673069|NCT01523587|183241141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0078|TWO_SIDED|95.0|0.66|0.94||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Dyspnoea||0.94|0.66|0.0078
91673070|NCT01523587|183241141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.869|TWO_SIDED|95.0|0.82|1.18||p-value calculated using log rank test stratified by race|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Pain||1.18|0.82|0.8690
91673071|NCT01523587|183241142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.34||0.0091|TWO_SIDED|95.0|-6.15|-0.88|||Regression, Cox|||The results shown relate to Change in scores over time for: Coughing.||-0.88|-6.15|0.0091
91673072|NCT01523587|183241142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.15||0.0024|TWO_SIDED|95.0|-5.75|-1.25|||Regression, Cox|||The results shown relate to Change in scores over time for: Dyspnoea.||-1.25|-5.75|0.0024
91716009|NCT03575702|183322764|NON_INFERIORITY|The non-inferiority margin is considered as change in mean daily urination episodes of 0,8 episodes per day|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.5595|ONE_SIDED|95.0||0.38|||ANCOVA|The number of urination episodes at the initiation of therapy is used as covariate, and the therapy group is used as a factor.||"The null hypothesis is that effect of Urotol according to the assessment of mean daily urination episodes exceeds effect of Uritos.~A sample containing of 222 patients (111 per study group) is considered sufficient to prove the alternative hypothesis at the significance level 0.025% and study power 80%. Given the expected drop out rate during the treatment period, the total number of patients to be randomized is 300 (150 in each group)."||0.38||=0.5595
91673073|NCT01523587|183241142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.32||0.0384|TWO_SIDED|95.0|-5.33|-0.15|||Regression, Cox|||The results shown relate to Change in scores over time for: Pain.||-0.15|-5.33|0.0384
91673074|NCT02709486|183241143|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0088|TWO_SIDED|95.0|-0.81|-0.12||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.81|0.0088
91673075|NCT02709486|183241143|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.97|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.97|0.0006
91673076|NCT02709486|183241144|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.18||0.0008|TWO_SIDED|95.0|-0.93|-0.24||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-0.93|0.0008
91716010|NCT03575702|183322765|OTHER||||||=|0.0008|||||||ANCOVA|||||||=0.0008
91716011|NCT03575702|183322766|OTHER||||||=|0.0099|||||||ANCOVA|||||||=0.0099
91716012|NCT03575702|183322767|OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91716013|NCT03575702|183322768|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 2||||||<0.0001
91639453|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.376||0.0142|TWO_SIDED|95.0|0.75|6.31|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.31|0.75|0.0142
91639454|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|1.419||0.5547|TWO_SIDED|95.0|-2.02|3.71|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.71|-2.02|0.5547
91716014|NCT03575702|183322768|OTHER||||||=|0.0236|||||||ANCOVA|Changes in number of daily incontinence episodes - week 4||||||=0.0236
91639455|NCT00612456|183170804|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|2.287||0.9114|TWO_SIDED|95.0|-4.37|4.88|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.88|-4.37|0.9114
91639456|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.383||0.0534|TWO_SIDED|95.0|-0.01|1.53|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.53|-0.01|0.0534
91639457|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.409||0.0508|TWO_SIDED|95.0|0.0|1.64|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.64|-0.00|0.0508
91639458|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.61||||0.3141|TWO_SIDED|95.0|-0.6|1.83|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.83|-0.60|0.3141
91639459|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.395||0.6018|TWO_SIDED|95.0|-1.04|0.62|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||0.62|-1.04|0.6018
91639460|NCT00612456|183170807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.476||0.0509|TWO_SIDED|95.0|0.0|2.0||Statistics has been presented for least square means.|ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||2.00|-0.00|0.0509
91639461|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.566||0.3976|TWO_SIDED|95.0|-0.7|1.68|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||1.68|-0.70|0.3976
91639462|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.385||0.241|TWO_SIDED|95.0|-0.32|1.23|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.23|-0.32|0.2410
91639463|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.412||0.0032|TWO_SIDED|95.0|0.44|2.09|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||2.09|0.44|0.0032
91639464|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.581||0.3185|TWO_SIDED|95.0|-0.58|1.75|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.75|-0.58|0.3185
91639465|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.377||0.1074|TWO_SIDED|95.0|-0.14|1.37|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.37|-0.14|0.1074
91639466|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.402||0.0403|TWO_SIDED|95.0|0.04|1.65|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.65|0.04|0.0403
91639467|NCT00612456|183170807|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.594||0.249|TWO_SIDED|95.0|-0.5|1.88|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.88|-0.50|0.2490
91639468|NCT00808665|183170827|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91716015|NCT03575702|183322768|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 8||||||<0.0001
91716016|NCT03575702|183322768|OTHER||||||=|0.0018|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 2||||||=0.0018
91639469|NCT01830621|183170832|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.337|TWO_SIDED|95.0|0.88|1.46|||Log Rank|||||1.46|0.88|0.337
91639470|NCT01830621|183170833|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.837|TWO_SIDED|95.0|0.76|1.26|||Log Rank|||||1.26|0.76|0.837
91639471|NCT01830621|183170834|SUPERIORITY||Odds Ratio (OR)|0.98||||0.955|TWO_SIDED|95.0|0.48|2.0|||Cochran-Mantel-Haenszel|||||2.00|0.48|0.955
91639472|NCT01830621|183170836|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91639473|NCT03223649|183170845|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.035||0.005|TWO_SIDED|95.0|-0.17|-0.03||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.03|-.17|0.005
91639474|NCT03223649|183170846|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.349|TWO_SIDED|95.0|-0.033|0.011||Unadjusted P-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.011|-.033|0.349
91639475|NCT03223649|183170847|SUPERIORITY||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.045|TWO_SIDED|95.0|-0.084|-0.002||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.002|-.084|.045
91716017|NCT03575702|183322768|OTHER||||||=|0.3835|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 4||||||=0.3835
91716018|NCT03575702|183322768|OTHER||||||=|0.0088|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 8||||||=0.0088
91716019|NCT03575702|183322768|OTHER||||||=|0.0004|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 2||||||=0.0004
91673077|NCT02709486|183241144|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.36||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.36|-1.05|<.0001
91673078|NCT02709486|183241145|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1092|TWO_SIDED|95.0|-0.24|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.24|0.1092
91673079|NCT02709486|183241145|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0051|TWO_SIDED|95.0|-0.32|-0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.32|0.0051
91673080|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.94|-0.4|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-0.94|<.0001
91673081|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0149|TWO_SIDED|95.0|-0.61|-0.07|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.61|0.0149
91673082|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.08|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.08|<.0001
91673083|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.07|<.0001
91673084|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.92|<.0001
91673085|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.07|<.0001
91716020|NCT03575702|183322768|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 4||||||<0.0001
91673086|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.05|<.0001
91716021|NCT03575702|183322768|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 8||||||<0.0001
91716022|NCT03575702|183322769|OTHER|||||||0.0008|||||||ANCOVA|||||||0.0008
91716023|NCT03575702|183322770|OTHER||||||=|0.1348|||||||ANCOVA|Week 2 changes||||||=0.1348
91716024|NCT03575702|183322770|OTHER||||||=|0.3199|||||||ANCOVA|Week 4 changes||||||=0.3199
91716025|NCT03575702|183322770|OTHER||||||=|0.9537|||||||ANCOVA|Week 8 changes||||||=0.9537
91716026|NCT03575702|183322771|OTHER||||||=|0.5321|||||||t-test, 1 sided|Change week 12||||||=0.5321
91716027|NCT03575702|183322772|OTHER||||||=|0.4839|||||||t-test, 1 sided|Change week 12||||||=0.4839
91716028|NCT03575702|183322773|OTHER||||||=|0.86|||||||Chi-squared|||||||=0.86
91716029|NCT00490035|183322779|SUPERIORITY_OR_OTHER_LEGACY||Percentage Reduction over Placebo|6.5|||=|0.261|TWO_SIDED|95.0|-5.2|16.9|||ANCOVA|||In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.||16.9|-5.2|=0.261
91485579|NCT03438383|182844267|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.008
91485580|NCT03438383|182844267|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.013||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.013
91485581|NCT03438383|182844268|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.05
91716030|NCT05559905|183322807|SUPERIORITY||Difference in Least Squares Mean|-0.29||||0.578|TWO_SIDED|90.0|-1.16|0.58|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.58|-1.16|0.578
91716031|NCT05559905|183322808|SUPERIORITY||Difference in Least Squares Mean|-2.69||||0.201|TWO_SIDED|90.0|-6.17|-0.79|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||-0.79|-6.17|0.201
91716032|NCT05559905|183322814|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.736|TWO_SIDED|90.0|-3.65|2.42|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.42|-3.65|0.736
91716033|NCT05559905|183322815|SUPERIORITY||Difference in Least Squares Mean|-1.93||||0.646|TWO_SIDED|90.0|-8.88|5.02|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||5.02|-8.88|0.646
91716034|NCT05559905|183322816|SUPERIORITY||Difference in Least Squares Mean|-0.14||||0.849|TWO_SIDED|90.0|-1.31|1.04|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.04|-1.31|0.849
91716035|NCT05559905|183322817|SUPERIORITY||Difference in Least Squares Mean|-2.09||||0.371|TWO_SIDED|90.0|-5.97|1.78|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.78|-5.97|0.371
91716036|NCT05559905|183322818|SUPERIORITY||Difference in Least Squares Mean|-1.82||||0.36|TWO_SIDED|90.0|-5.11|1.47|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.47|-5.11|0.360
91716037|NCT05559905|183322819|SUPERIORITY||Difference in Least Squares Mean|-0.46||||0.459|TWO_SIDED|90.0|-1.5|0.57|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.57|-1.50|0.459
91485582|NCT03438383|182844268|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.55||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.55
91716038|NCT05559905|183322821|SUPERIORITY||Difference in Percent (%)|3.42|||||TWO_SIDED|95.0|-18.28|24.5||||||||24.50|-18.28|
91716039|NCT05559905|183322822|SUPERIORITY||Difference in Percent (%)|2.89|||||TWO_SIDED|95.0|-19.37|25.69||||||||25.69|-19.37|
91716040|NCT05559905|183322823|SUPERIORITY||Difference in Percent (%)|-2.63|||||TWO_SIDED|95.0|-25.07|19.91||||||||19.91|-25.07|
91716041|NCT05559905|183322824|SUPERIORITY||Difference in Percent (%)|-16.18|||||TWO_SIDED|95.0|-36.77|5.64||||||||5.64|-36.77|
91716042|NCT05559905|183322825|SUPERIORITY||Difference in Percent (%)|-2.89|||||TWO_SIDED|95.0|-25.69|19.37||||||||19.37|-25.69|
91716043|NCT05559905|183322826|SUPERIORITY||Difference in Least Squares Mean|-0.69||||0.253|TWO_SIDED|90.0|-1.68|0.31|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.31|-1.68|0.253
91673087|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.09|<.0001
91673088|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.93|-0.26|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.93|0.0005
91673089|NCT02709486|183241146|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.93|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.93|0.0004
91673090|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.95|-0.42|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-0.95|<.0001
91673091|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.7|-0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.70|0.0014
91673092|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.09|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.09|<.0001
91673093|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.08|<.0001
91673094|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.93|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-0.93|<.0001
91673095|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.06|<.0001
91716044|NCT05559905|183322827|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.1708||95.0|0.83|3.57|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.57|0.83|0.1708
91673096|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.11|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.11|<.0001
91673097|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.15|<.0001
91673098|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.00|<.0001
91716045|NCT05559905|183322828|SUPERIORITY||Difference in Least Squares Mean|-5.93||||0.257|TWO_SIDED|90.0|-14.61|2.75|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.75|-14.61|0.257
91639476|NCT03223649|183170848|SUPERIORITY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.226|TWO_SIDED|95.0|-0.051|0.013||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.013|-0.051|0.226
91673099|NCT02709486|183241148|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.00|<.0001
91673100|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.33|-0.12|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.33|<.0001
91673101|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.0022|TWO_SIDED|95.0|-0.27|-0.06|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.27|0.0022
91673102|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.35|<.0001
91673103|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.43|<.0001
91673104|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0029|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.28|0.0029
91673105|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.37|<.0001
91673106|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.4|-0.17|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.40|<.0001
91673107|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.43|-0.2|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.43|<.0001
91673108|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0352|TWO_SIDED|95.0|-0.26|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.26|0.0352
91716046|NCT05559905|183322829|SUPERIORITY||Difference in Least Squares Mean|-0.58||||0.453|TWO_SIDED|90.0|-1.88|0.71|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.71|-1.88|0.453
91716047|NCT05559905|183322830|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.9121|TWO_SIDED|95.0|0.44|2.51|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.51|0.44|0.9121
91526447|NCT03500640|182928054|SUPERIORITY|||||||0.069||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.069
91639477|NCT03223649|183170849|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-6.884|-4.716|||t-test, 2 sided|||||-4.716|-6.884|<0.001
91526448|NCT03500640|182928055|SUPERIORITY|||||||0.193||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.193
91639478|NCT03223649|183170850|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.116||0.39|TWO_SIDED|95.0|-0.33|0.13|||t-test, 2 sided|||||0.130|-0.330|0.39
91716048|NCT05559905|183322831|SUPERIORITY||Difference in Least Squares Mean|-1.83||||0.377|TWO_SIDED|90.0|-5.25|1.6|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.60|-5.25|0.377
91673109|NCT02709486|183241150|SUPERIORITY||Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-0.37|<.0001
91716049|NCT05559905|183322832|SUPERIORITY||Difference in Least Squares Mean|-0.13||||0.958|TWO_SIDED|90.0|-4.28|4.02|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||4.02|-4.28|0.958
91673110|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.59|3.14|||Regression, Logistic|||Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.59|<.0001
91673111|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0085|TWO_SIDED|95.0|1.12|2.18|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.12|0.0085
91673112|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.0001|TWO_SIDED|95.0|1.89|3.88|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.88|1.89|<.0001
91673113|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.28|1.62|<.0001
91673114|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0005|TWO_SIDED|95.0|1.33|2.75|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.33|0.0005
91716050|NCT05559905|183322833|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.52|TWO_SIDED|90.0|-2.21|0.98|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.98|-2.21|0.520
91716051|NCT05559905|183322835|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.0459|TWO_SIDED|95.0|0.99|5.07|||Log Rank|Two-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||5.07|0.99|0.0459
91716052|NCT03258593|183322862|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|67.5||||0.202|TWO_SIDED|95.0|25.0|75.0||Unadjusted p-value|Wilcoxon Rank sum test|||||75|25|0.202
91716053|NCT03258593|183322862|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|114.0||||0.667|TWO_SIDED|95.0|67.9|160.3||Unadjusted p-value|Wilcoxon Rank sum test|||||160.3|67.9|0.667
91673115|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0005|TWO_SIDED|95.0|1.32|2.73|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.73|1.32|0.0005
91716054|NCT03258593|183322862|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|44.1||||0.463|TWO_SIDED|95.0|25.0|75.0|||Wilcoxon Rank sum test|||||75|25|0.463
91673116|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0009|TWO_SIDED|95.0|1.31|2.86|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|1.31|0.0009
91673117|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0008|TWO_SIDED|95.0|1.32|2.89|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.32|0.0008
91673118|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0002|TWO_SIDED|95.0|1.41|3.01|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|1.41|0.0002
91716055|NCT03258593|183322864|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|-17.75||||0.863|TWO_SIDED|95.0|-211.6|170.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||170.3|-211.6|0.863
91716056|NCT03258593|183322864|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|114.1||||0.666|TWO_SIDED|95.0|67.9|160.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||160.3|67.9|0.666
91716057|NCT03258593|183322864|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|21.3||||0.949|TWO_SIDED|95.0|-203.9|269.9|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||269.9|-203.9|0.949
91716058|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|4.34|||<|0.001|TWO_SIDED|95.0|1.7|38.0||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 3 weeks compared to their respective baseline values.||38.0|1.7|<0.001
91673119|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0022|TWO_SIDED|95.0|1.23|2.57|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.57|1.23|0.0022
91673120|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.54|1.21|0.0032
91716059|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|3.29|||<|0.001|TWO_SIDED|95.0|1.5|11.25||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 5 weeks compared to their respective baseline values.||11.25|1.5|<0.001
91639479|NCT03223649|183170851|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.648|TWO_SIDED|95.0|-0.071|0.114|||ANCOVA|Dependent variable in Kcal log transformed, comparison adjusted for: age(y), lean mass(kg), fat mass(kg)||||0.114|-0.071|0.648
91639480|NCT03223649|183170852|SUPERIORITY||Mean Difference (Final Values)|0.834|STANDARD_ERROR_OF_MEAN|1.354||0.539|TWO_SIDED|95.0|-1.857|3.525|||ANCOVA|Adjusted for age (years)||||3.525|-1.857|0.539
91639481|NCT03223649|183170853|SUPERIORITY||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.766||0.55|TWO_SIDED|95.0|-4.57|2.45|||ANCOVA|Adjusted for age (years)||||2.45|-4.57|0.550
91639482|NCT03223649|183170854|SUPERIORITY||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.681||0.741|TWO_SIDED|95.0|-1.127|1.579|||ANCOVA|Adjusted for age (years)||||1.579|-1.127|0.741
91639483|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.2|||<|0.0001|TWO_SIDED|95.0|15.9|37.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.0|15.9|<.0001
91639484|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|25.3|||<|0.0001|TWO_SIDED|95.0|17.1|37.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.3|17.1|<.0001
91639485|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.4|||<|0.0001|TWO_SIDED|95.0|14.9|33.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.7|14.9|<.0001
91639486|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.5|||<|0.0001|TWO_SIDED|95.0|10.8|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|10.8|<.0001
91639487|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|147.0||||0.1148|TWO_SIDED|95.0|93.7|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|93.7|0.1148
91639488|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|153.0||||0.044|TWO_SIDED|95.0|101.0|233.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||233|101|0.0440
91639489|NCT05664672|183170861|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|136.0||||0.2422|TWO_SIDED|95.0|87.8|210.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||210|87.8|0.2422
91673121|NCT02709486|183241152|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0013|TWO_SIDED|95.0|1.27|2.69|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.69|1.27|0.0013
91673122|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.59|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.30|0.0006
91673123|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.53||||0.016|TWO_SIDED|95.0|1.08|2.16|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.08|0.0160
91716060|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.4|||<|0.05|TWO_SIDED|95.0|0.1|0.7||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α) at 3 weeks compared to their respective baseline values.||0.7|0.1|<0.05
91673124|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
91673125|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5118|TWO_SIDED|95.0|0.75|1.8|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.80|0.75|0.5118
91673126|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0093|TWO_SIDED|95.0|1.25|4.81|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.81|1.25|0.0093
91673127|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3017|TWO_SIDED|95.0|0.71|3.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|0.71|0.3017
91673128|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.4||||0.216|TWO_SIDED|95.0|0.6|9.58|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.58|0.60|0.2160
91673129|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.33||||0.7174|TWO_SIDED|95.0|0.29|6.08|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.08|0.29|0.7174
91673130|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.45|2.87|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.45|<.0001
91673131|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0006|TWO_SIDED|95.0|1.29|2.54|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.29|0.0006
91673132|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0024|TWO_SIDED|95.0|1.23|2.65|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.23|0.0024
91673133|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.49|3.16|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.49|<.0001
91673134|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0373|TWO_SIDED|95.0|1.04|3.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.04|0.0373
91716061|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.24||||0.052|TWO_SIDED|95.0|-0.01|0.96||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α ) at 5 weeks compared to their respective baseline values.||0.96|-0.01|0.052
91716062|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.39||||0.055|TWO_SIDED|95.0|-0.03|4.61||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 6 (IL-6) at 3 weeks as compared to their respective baseline values.||4.61|-0.03|0.055
91716063|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.54||||0.06|TWO_SIDED|95.0|-0.06|1.96|||Paired samples Wilcoxon rank sum test|Hochberg adjustment may be used.||Interleukin 6 (IL-6) at 5 weeks as compared to their respective baseline values.||1.96|-0.06|0.06
91673135|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.17||||0.0046|TWO_SIDED|95.0|1.27|3.72|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.27|0.0046
91673136|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0683|TWO_SIDED|95.0|0.92|9.47|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.47|0.92|0.0683
91673137|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0214|TWO_SIDED|95.0|1.22|11.66|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.66|1.22|0.0214
91716064|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.73||||0.42|TWO_SIDED|95.0|-1.63|1.62||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 3 weeks as compared to their respective baseline values.||1.62|-1.63|0.420
91716065|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|-0.39||||0.733|TWO_SIDED|95.0|-1.315|1.31||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 5 weeks as compared to their respective baseline values.||1.31|-1.315|0.733
91716066|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.12||||0.01|TWO_SIDED|95.0|0.04|0.21||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 3 weeks as compared to their respective baseline values.||0.21|0.04|0.010
91792954|NCT01709578|183463380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.801|||<|0.0001|TWO_SIDED|95.0|2.948|11.413||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.413|2.948|<0.0001
91792955|NCT01709578|183463381|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.306|||<|0.0001|TWO_SIDED|95.0|-10.444|-4.167||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.167|-10.444|<0.0001
91792956|NCT01709578|183463381|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.727|||<|0.0001|TWO_SIDED|95.0|-12.833|-6.622||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.622|-12.833|<0.0001
91639490|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.9||||0.0994|TWO_SIDED|95.0|22.7|110.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||110|22.7|0.0994
91639491|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|65.8||||0.4162|TWO_SIDED|95.0|32.0|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|32.0|0.4162
91639492|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|47.5|215.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||215|47.5|1.0000
91639493|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2.23|||<|0.0001|TWO_SIDED|95.0|1.01|4.94|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||4.94|1.01|<.0001
91639494|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2230.0|||<|0.0001|TWO_SIDED|95.0|965.0|5160.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||5160|965|<.0001
91639495|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2940.0|||<|0.0001|TWO_SIDED|95.0|1350.0|6400.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||6400|1350|<.0001
91673138|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.58|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.30|0.0006
91792957|NCT01709578|183463382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183||||0.0078|TWO_SIDED|95.0|-0.318|-0.048||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.048|-0.318|0.0078
91792958|NCT01709578|183463382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.242||||0.0004|TWO_SIDED|95.0|-0.376|-0.109||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.109|-0.376|0.0004
91792959|NCT01709578|183463383|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25||||0.0004|TWO_SIDED|95.0|1.45|5.049||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.049|1.450|0.0004
91792960|NCT01709578|183463383|SUPERIORITY_OR_OTHER||LS Mean Difference|4.075|||<|0.0001|TWO_SIDED|95.0|2.305|5.846||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.846|2.305|<0.0001
91792961|NCT01709578|183463384|SUPERIORITY_OR_OTHER||LS Mean Difference|1.515||||0.2026|TWO_SIDED|95.0|-0.818|3.848||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3.848|-0.818|0.2026
91792962|NCT01709578|183463384|SUPERIORITY_OR_OTHER||LS Mean Difference|2.013||||0.0854|TWO_SIDED|95.0|-0.282|4.309||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.309|-0.282|0.0854
91792963|NCT03505671|183463477|OTHER|||||||0.61|||||||ANCOVA|||||||0.61
91526449|NCT03500640|182928056|SUPERIORITY|||||||0.197||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.197
91526450|NCT03500640|182928057|SUPERIORITY|||||||0.594||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.594
91526451|NCT03500640|182928058|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||||||0.328
91526452|NCT03500640|182928059|SUPERIORITY|||||||0.398||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.398
91639496|NCT05664672|183170862|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4530.0|||<|0.0001|TWO_SIDED|95.0|2020.0|10200.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10200|2020|<.0001
91639497|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.69|||<|0.0001|TWO_SIDED|95.0|3.29|9.87|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||9.87|3.29|<.0001
91639498|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|8.08|||<|0.0001|TWO_SIDED|95.0|4.88|13.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||13.4|4.88|<.0001
91639499|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.58|||<|0.0001|TWO_SIDED|95.0|3.88|11.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||11.2|3.88|<.0001
91639500|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.03|||<|0.0001|TWO_SIDED|95.0|3.46|10.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10.5|3.46|<.0001
91639501|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.4||||0.9972|TWO_SIDED|95.0|52.7|169.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||169|52.7|0.9972
91639502|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|134.0||||0.4655|TWO_SIDED|95.0|77.9|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|77.9|0.4655
91639503|NCT05664672|183170863|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|109.0||||0.9851|TWO_SIDED|95.0|62.1|192.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||192|62.1|0.9851
91639504|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.7|||<|0.0001|TWO_SIDED|95.0|9.72|19.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.2|9.72|<.0001
91639505|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.6|||<|0.0001|TWO_SIDED|95.0|12.1|22.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.6|12.1|<.0001
91639506|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.4|||<|0.0001|TWO_SIDED|95.0|9.68|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.68|<.0001
91673139|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0048|TWO_SIDED|95.0|1.16|2.28|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.28|1.16|0.0048
91673140|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0012|TWO_SIDED|95.0|1.27|2.65|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.27|0.0012
91673141|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.68|3.47|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.47|1.68|<.0001
91792964|NCT03505671|183463477|OTHER||Correlation Coefficient|0.15|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (overall, N=20)|||||
91639507|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.7|||<|0.0001|TWO_SIDED|95.0|11.2|22.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.2|11.2|<.0001
91639508|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.8||||0.7167|TWO_SIDED|95.0|60.6|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|60.6|0.7167
91639509|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|105.0||||0.9864|TWO_SIDED|95.0|75.3|147.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||147|75.3|0.9864
91639510|NCT05664672|183170864|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|85.1||||0.5911|TWO_SIDED|95.0|60.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|60.1|0.5911
91639511|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|29.6|||<|0.0001|TWO_SIDED|95.0|21.8|40.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.0|21.8|<.0001
91639512|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.3|||<|0.0001|TWO_SIDED|95.0|21.5|37.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.4|21.5|<.0001
91639513|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|44.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||44.2|24.8|<.0001
91639514|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.5|||<|0.0001|TWO_SIDED|95.0|27.7|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|27.7|<.0001
91639515|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|78.8||||0.195|TWO_SIDED|95.0|57.3|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|57.3|0.1950
91673142|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0537|TWO_SIDED|95.0|0.99|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|0.99|0.0537
91673143|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0001|TWO_SIDED|95.0|1.58|4.13|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|1.58|0.0001
91673144|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1155|TWO_SIDED|95.0|0.82|6.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.27|0.82|0.1155
91673145|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0271|TWO_SIDED|95.0|1.13|7.96|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.96|1.13|0.0271
91673146|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.63|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.30|0.0007
91792965|NCT03505671|183463477|OTHER||Correlation coefficient|0.25|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (intervention, N=9)|||||
91792966|NCT03505671|183463477|OTHER||Correlation coefficient|0.09|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (Usual Care, N=11)|||||
91792967|NCT03505671|183463478|OTHER|||||||0.91||||||P value for the motor subscale|ANCOVA|||||||0.91
91673147|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0011|TWO_SIDED|95.0|1.26|2.56|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.26|0.0011
91673148|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0009|TWO_SIDED|95.0|1.27|2.52|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.27|0.0009
91673149|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.47|2.91|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.91|1.47|<.0001
91673150|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0064|TWO_SIDED|95.0|1.18|2.78|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.18|0.0064
91673151|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.68||||0.018|TWO_SIDED|95.0|1.09|2.58|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.09|0.0180
91673152|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|5.61||||0.0006|TWO_SIDED|95.0|2.09|15.08|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||15.08|2.09|0.0006
91673153|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0034|TWO_SIDED|95.0|1.64|12.13|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.13|1.64|0.0034
91673154|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0022
91673155|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0014|TWO_SIDED|95.0|1.25|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.25|0.0014
91673156|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0003|TWO_SIDED|95.0|1.33|2.64|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.33|0.0003
91673157|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.68||||0.003|TWO_SIDED|95.0|1.19|2.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.36|1.19|0.0030
91673158|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0754|TWO_SIDED|95.0|0.96|2.24|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.24|0.96|0.0754
91526453|NCT03500640|182928060|SUPERIORITY|||||||0.288||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.288
91526454|NCT03500640|182928061|SUPERIORITY|||||||0.592||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.592
91673159|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0253|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.06|0.0253
91673160|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0098|TWO_SIDED|95.0|1.3|6.83|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.83|1.30|0.0098
91673161|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.72||||0.223|TWO_SIDED|95.0|0.72|4.13|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|0.72|0.2230
91673162|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0201|TWO_SIDED|95.0|1.07|2.12|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.12|1.07|0.0201
91673163|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0021|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0021
91716067|NCT03258593|183322866|OTHER|Other: median difference|Median Difference (Net)|0.1||||0.014|TWO_SIDED|95.0|0.04|0.4||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 5 weeks as compared to their respective baseline values.||0.40|0.04|0.014
91673164|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
91673165|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0004|TWO_SIDED|95.0|1.32|2.64|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.32|0.0004
91673166|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.32||||0.2031|TWO_SIDED|95.0|0.86|2.01|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.01|0.86|0.2031
91673167|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0867|TWO_SIDED|95.0|0.95|2.18|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|0.95|0.0867
91673168|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1746|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.22|0.77|0.1746
91673169|NCT02709486|183241154|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1039|TWO_SIDED|95.0|0.87|4.57|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.57|0.87|0.1039
91673170|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0003|TWO_SIDED|95.0|1.33|2.68|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|1.33|0.0003
91673171|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0286|TWO_SIDED|95.0|1.04|2.1|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|1.04|0.0286
91673172|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1031|TWO_SIDED|95.0|0.93|2.27|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.27|0.93|0.1031
91673173|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2033|TWO_SIDED|95.0|0.85|2.1|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|0.85|0.2033
91673174|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0064|TWO_SIDED|95.0|1.34|5.86|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.86|1.34|0.0064
91673175|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.44||||0.3706|TWO_SIDED|95.0|0.65|3.23|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.65|0.3706
91716068|NCT03258593|183322868|OTHER|One curve estimated in this cohort. Not compared to any other curves.|Kaplan-Meier product-limit|13.2|||||TWO_SIDED|97.5|2.5|97.5||Unadjusted p-value|Kaplan-Meier product-limit estimates|||Disease free survival time was evaluated with the product-limit estimator by Kaplan-Meier test.||97.5|2.5|
91792968|NCT03505671|183463478|OTHER|||||||0.55||||||P value for autonomic subscale|ANCOVA|||||||0.55
91792969|NCT03505671|183463479|OTHER|||||||0.41||||||P value for baseline numbness or tingling severity data|Fisher Exact|||||||0.41
91526455|NCT03500640|182928062|SUPERIORITY|||||||0.805||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.805
91673176|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.39||||0.2121|TWO_SIDED|95.0|0.61|9.41|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.41|0.61|0.2121
91673177|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4859|TWO_SIDED|95.0|0.39|7.11|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.11|0.39|0.4859
91673178|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.6|3.17|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.17|1.60|<.0001
91673179|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.96|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.50|<.0001
91792970|NCT03505671|183463479|OTHER|||||||0.22||||||P value for baseline numbness or tingling interference data|Fisher Exact|||||||0.22
91485583|NCT03438383|182844268|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.13||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48h post-operatively||||0.13
91673180|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.91||||0.002|TWO_SIDED|95.0|1.27|2.87|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.27|0.0020
91673181|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.53|3.4|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.53|<.0001
91673182|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0107|TWO_SIDED|95.0|1.21|4.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.14|1.21|0.0107
91673183|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0126|TWO_SIDED|95.0|1.18|4.02|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.02|1.18|0.0126
91673184|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.67||||0.1516|TWO_SIDED|95.0|0.7|10.26|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||10.26|0.70|0.1516
91673185|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|4.49||||0.021|TWO_SIDED|95.0|1.25|16.05|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||16.05|1.25|0.0210
91673186|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0034|TWO_SIDED|95.0|1.18|2.31|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.18|0.0034
91673187|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.75||||0.001|TWO_SIDED|95.0|1.26|2.45|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.26|0.0010
91673188|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0014|TWO_SIDED|95.0|1.27|2.71|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.71|1.27|0.0014
91673189|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.46|3.1|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.46|<.0001
91673190|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0007|TWO_SIDED|95.0|1.49|4.55|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.55|1.49|0.0007
91673191|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0018|TWO_SIDED|95.0|1.39|4.24|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.24|1.39|0.0018
91673192|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|4.1||||0.015|TWO_SIDED|95.0|1.31|12.79|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.79|1.31|0.0150
91673193|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0211|TWO_SIDED|95.0|1.22|11.78|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.78|1.22|0.0211
91792971|NCT03505671|183463479|OTHER|||||||0.58||||||Week 12 p value for numbness or tingling severity data|Fisher Exact|||||||0.58
91526456|NCT03500640|182928063|SUPERIORITY|||||||0.421||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||The p value provided here is for the physical component summary score (PCS) only||||0.421
91526457|NCT03500640|182928064|SUPERIORITY|The p value provided here is for the physical component summary score (PCS) only||||||0.16|||||||t-test, 2 sided|||||||0.160
91673194|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.43|2.84|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.84|1.43|<.0001
91792972|NCT03505671|183463479|OTHER|||||||0.12||||||P value for Week 12 numbness or tingling interference data|Fisher Exact|||||||0.12
91485584|NCT03438383|182844268|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.011||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.011
91673195|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.55|3.1|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.55|<.0001
91673196|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.47|3.0|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.00|1.47|<.0001
91673197|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.08|||<|0.0001|TWO_SIDED|95.0|1.46|2.96|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.46|<.0001
91673198|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.74||||0.018|TWO_SIDED|95.0|1.1|2.76|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.10|0.0180
91673199|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0072|TWO_SIDED|95.0|1.18|2.94|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.18|0.0072
91673200|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|10.84||||0.0015|TWO_SIDED|95.0|2.49|47.22|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||47.22|2.49|0.0015
91673201|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|8.62||||0.0044|TWO_SIDED|95.0|1.96|37.96|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||37.96|1.96|0.0044
91673202|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0018|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0018
91673203|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0011|TWO_SIDED|95.0|1.26|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.26|0.0011
91673204|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0035|TWO_SIDED|95.0|1.19|2.38|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.38|1.19|0.0035
91673205|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
91673206|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0155|TWO_SIDED|95.0|1.11|2.72|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.11|0.0155
91673207|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1549|TWO_SIDED|95.0|0.88|2.2|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.20|0.88|0.1549
91673208|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0212|TWO_SIDED|95.0|1.18|7.37|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.37|1.18|0.0212
91673209|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0373|TWO_SIDED|95.0|1.06|6.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.57|1.06|0.0373
91673210|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.29|2.57|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.29|0.0006
91792973|NCT03505671|183463479|OTHER|||||||0.57||||||Week 12 - Baseline p value for numbness or tingling severity data|Fisher Exact|||||||0.57
91639516|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|75.5||||0.0699|TWO_SIDED|95.0|56.1|102.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||102|56.1|0.0699
91526458|NCT03500640|182928065|SUPERIORITY|||||||0.196||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||||||0.196
91639517|NCT05664672|183170865|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.3||||0.7041|TWO_SIDED|95.0|64.7|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|64.7|0.7041
91639518|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.57|18.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.4|9.57|<.0001
91639519|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.84|17.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||17.9|9.84|<.0001
91639520|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.6|||<|0.0001|TWO_SIDED|95.0|9.93|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.93|<.0001
91639521|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|9.28|||<|0.0001|TWO_SIDED|95.0|6.67|12.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.9|6.67|<.0001
91639522|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0404|TWO_SIDED|95.0|101.0|202.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||202|101|0.0404
91639523|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0243|TWO_SIDED|95.0|104.0|198.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||198|104|0.0243
91639524|NCT05664672|183170866|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|146.0||||0.0215|TWO_SIDED|95.0|105.0|205.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||205|105|0.0215
91639525|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.37|||<|0.0001|TWO_SIDED|95.0|3.69|7.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.80|3.69|<.0001
91639526|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.65|||<|0.0001|TWO_SIDED|95.0|4.01|7.96|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.96|4.01|<.0001
91639527|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.61|||<|0.0001|TWO_SIDED|95.0|3.92|8.03|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.03|3.92|<.0001
91716069|NCT05457257|183322883|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.726|TWO_SIDED|95.0|0.46|3.45||The 2-sided nominal p-values were calculated using the log-rank test stratified by the same variables selected in the primary pooling strategy, using the Breslow method for handling ties.|Log Rank||The Hazard ratio and CI were calculated using a Cox Proportional Hazards model adjusted for the variables. The Efron approach was used for handling ties. A hazard ratio \<1 favours Olaparib 300 mg bd.|The explanation of statistical method||3.45|0.46|0.726
91526459|NCT03500640|182928066|SUPERIORITY|||||||0.532||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.532
91526460|NCT01087996|182928076|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91526461|NCT01087996|182928077|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||||||0.75
91792974|NCT03505671|183463479|OTHER|||||||0.55||||||Week 12 - Baseline p value for numbness or tingling interference|Fisher Exact|||||||0.55
91673211|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.51|3.02|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.51|<.0001
91639528|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.09|||<|0.0001|TWO_SIDED|95.0|4.17|8.89|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.89|4.17|<.0001
91639529|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.1||||0.8335|TWO_SIDED|95.0|59.4|131.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||131|59.4|0.8335
91639530|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.9||||0.9622|TWO_SIDED|95.0|64.2|134.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||134|64.2|0.9622
91639531|NCT05664672|183170867|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.1||||0.9531|TWO_SIDED|95.0|62.8|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|62.8|0.9531
91639532|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.4|22.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.3|14.4|<.0001
91639533|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.8|22.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.1|14.8|<.0001
91673212|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0152|TWO_SIDED|95.0|1.09|2.18|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.09|0.0152
91673213|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0018|TWO_SIDED|95.0|1.23|2.45|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.23|0.0018
91673214|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.47||||0.097|TWO_SIDED|95.0|0.93|2.31|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|0.93|0.0970
91673215|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3435|TWO_SIDED|95.0|0.79|1.98|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.98|0.79|0.3435
91673216|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0236|TWO_SIDED|95.0|1.17|9.27|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.27|1.17|0.0236
91526462|NCT01087996|182928078|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91716070|NCT05457257|183322884|SUPERIORITY||Odds Ratio (OR)|2.4||||0.498|TWO_SIDED|95.0|0.2|59.66||A Fisher's exact test using mid p-values was used.|Regression, Logistic||Objective response rate compared using logistic regression adjusting for previous taxane use as a covariate. An odds ratio \>1 favours Olaparib 300 mg bd. CI calculated using profile likelihood method.|The explanation of statistical method||59.66|0.20|0.498
91716071|NCT05457257|183322885|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.44|TWO_SIDED|95.0|0.5|7.48||The 2-sided nominal p-values were calculated using the log-rank test stratified by the same covariates and using the Breslow method for handling ties.|Log Rank||The hazard ratio and CI were calculated using a Cox Proportional Hazards model with the Efron approach being used for handling ties, adjusting for covariates. A hazard ratio \<1 favours Olaparib 300 mg bd.|The explanation of statistical method||7.48|0.50|0.440
91792975|NCT03505671|183463480|OTHER|||||||0.99||||||P value for baseline numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
91792976|NCT03505671|183463480|OTHER|||||||0.99||||||P value for 12 weeks numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
91792977|NCT03505671|183463480|OTHER|||||||0.99||||||P value for week 12 - baseline change in numbness or tingling severity|Fisher Exact|||||||0.99
91792978|NCT03505671|183463481|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
91716072|NCT05457257|183322887|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.604|TWO_SIDED|95.0|0.2|2.88||The 2-sided nominal p-value was calculated using the log-rank test stratified by the same variables selected in the primary pooling strategy, using the Breslow method for handling ties.|Log Rank||The Hazard ratio and CI were calculated using a Cox Proportional Hazards model adjusted for the variables selected in the primary pooling strategy: none. The Efron approach was used for handling ties. A hazard ratio \<1 favours Olaparib 300 mg bd.|The explanation of statistical method||2.88|0.20|0.604
91716073|NCT05457257|183322890|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.889|TWO_SIDED|95.0|0.19|6.24||The 2-sided nominal p-values were calculated using the log-rank test stratified by the same covariates and using the Breslow method for handling ties.|Log Rank||The hazard ratio and CI were calculated using a Cox Proportional Hazards model with the Efron approach being used for handling ties, adjusting for covariates. A hazard ratio \<1 favours Olaparib 300 mg bd.|The explanation of statistical method||6.24|0.19|0.889
91673217|NCT02709486|183241155|SUPERIORITY||Odds Ratio (OR)|3.14||||0.0296|TWO_SIDED|95.0|1.12|8.81|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||8.81|1.12|0.0296
91673218|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|2.14||||0.0132|TWO_SIDED|95.0|1.17|3.9|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.90|1.17|0.0132
91673219|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1274|TWO_SIDED|95.0|0.87|3.02|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|0.87|0.1274
91673220|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0016|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.76|1.44|0.0016
91673221|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|1.84|6.03|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.03|1.84|<.0001
91673222|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0089|TWO_SIDED|95.0|1.2|3.49|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.20|0.0089
91673223|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0012|TWO_SIDED|95.0|1.42|4.1|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.10|1.42|0.0012
91673224|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0006|TWO_SIDED|95.0|1.45|3.98|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.98|1.45|0.0006
91716074|NCT00359203|183322892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.04|TWO_SIDED|95.0|0.19|0.96|||Log Rank|The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.|numerator=pacemaker ON denominator=pacemaker OFF|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.||0.96|0.19|0.04
91716075|NCT00359203|183322892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.|Hazard Ratio (HR)|0.43||||0.039|TWO_SIDED|95.0|0.19|0.96||For the final analysis the threshold of statistical significance was set at 0.04.|Log Rank||Numerator=pacemaker ON denominator=pacemaker OFF|||0.96|0.19|0.039
91716076|NCT02131064|183322904|SUPERIORITY||Difference in tpCR rate|-11.71||||0.0126|TWO_SIDED|95.0|-20.95|-2.48||Threshold for significance at 5%|Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in tPCR rates between treatment arms was calculated using normal approximation.||-2.48|-20.95|0.0126
91792979|NCT03505671|183463482|OTHER|||||||0.69|||||||t-test, 2 sided|||||||0.69
91673225|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|1.92|5.21|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.21|1.92|<.0001
91673226|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0203|TWO_SIDED|95.0|1.1|3.06|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.10|0.0203
91673227|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.77|4.86|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.86|1.77|<.0001
91526463|NCT01087996|182928079|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91639534|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.8|||<|0.0001|TWO_SIDED|95.0|12.8|19.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.4|12.8|<.0001
91639535|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.6|22.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.7|14.6|<.0001
91639536|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.4||||0.9993|TWO_SIDED|95.0|78.2|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|78.2|0.9993
91639537|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.9||||0.9998|TWO_SIDED|95.0|79.7|123.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||123|79.7|0.9998
91639538|NCT05664672|183170868|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.4||||0.3019|TWO_SIDED|95.0|69.1|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|69.1|0.3019
91639539|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.3|||<|0.0001|TWO_SIDED|95.0|13.2|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|13.2|<.0001
91639540|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.7|||<|0.0001|TWO_SIDED|95.0|17.6|31.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||31.9|17.6|<.0001
91639541|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|19.3|||<|0.0001|TWO_SIDED|95.0|14.2|26.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||26.4|14.2|<.0001
91639542|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.0|||<|0.0001|TWO_SIDED|95.0|17.3|33.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.3|17.3|<.0001
91639543|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|76.1||||0.153|TWO_SIDED|95.0|54.0|107.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||107|54.0|0.1530
91673228|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0775|TWO_SIDED|95.0|0.95|2.55|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.55|0.95|0.0775
91673229|NCT02709486|183241157|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0064|TWO_SIDED|95.0|1.21|3.21|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.21|1.21|0.0064
91673230|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.70|<.0001
91792980|NCT03505671|183463483|OTHER|||||||0.46||||||P value for cross sectional area sural data|ANCOVA|||||||0.46
91526464|NCT01087996|182928080|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91526465|NCT01087996|182928081|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91526466|NCT01087996|182928082|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Repeated measures ANOVA|||||||0.87
91526467|NCT01087996|182928083|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Repeated measures ANOVA|||||||0.84
91716077|NCT02131064|183322905|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7557|TWO_SIDED|95.0|0.37|3.96|||Cochran-Mantel-Haenszel Chi-Square Test|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||||3.96|0.37|0.7557
91716078|NCT02131064|183322906|SUPERIORITY||Difference in BCS rate|-10.84||||0.0228|TWO_SIDED|95.0|-20.21|-1.47|||Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in BCS rate between treatment arms was calculated using normal approximation.||-1.47|-20.21|0.0228
91716079|NCT02131064|183322907|SUPERIORITY||Hazard Ratio (HR)|2.61||||0.0027|TWO_SIDED|95.0|1.36|4.98|||Log Rank|The Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||||4.98|1.36|0.0027
91716080|NCT02131064|183322908|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.52|2.4||||||||2.40|0.52|
91716081|NCT02131064|183322911|SUPERIORITY||Difference in Deterioration|-24.58|||||TWO_SIDED|95.0|-33.98|-15.19||||||95% CI for the difference in clinically meaningful deterioration in GHS/QoL score between treatment arms was calculated using normal approximation.||-15.19|-33.98|
91716082|NCT02131064|183322912|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0001|TWO_SIDED|95.0|0.46|0.78|||Log Rank|Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||Stratified cox proportional hazards regression model was used to estimate Hazard Ratio and CI. Stratification by hormonal receptor status and clinical stage at presentation (stratification factors).||0.78|0.46|0.0001
91716083|NCT02131064|183322923|SUPERIORITY||Difference in Deterioration|-16.63|||||TWO_SIDED|95.0|-26.32|-6.94||||||This is the statistical analysis for cognitive functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-6.94|-26.32|
91716084|NCT02131064|183322923|SUPERIORITY||Difference in Deterioration|-32.54|||||TWO_SIDED|95.0|-41.74|-23.34||||||This is the statistical analysis for physical functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-23.34|-41.74|
91716085|NCT02131064|183322923|SUPERIORITY||Difference in Deterioration|-28.88|||||TWO_SIDED|95.0|-37.95|-19.8||||||This is the statistical analysis for role functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-19.80|-37.95|
91716086|NCT02554760|183322926|OTHER||success proportion|84.2|||||TWO_SIDED|95.0|60.4|92.3|||Catagorical tabulation|||||92.3|60.4|
91716087|NCT02554760|183322926|OTHER||success proportion|78.9|||||TWO_SIDED|95.0|54.4|93.9||||||||93.9|54.4|
91716088|NCT00593918|183322929|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.04
91716089|NCT00593918|183322930|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.14
91716090|NCT00871234|183322942|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.36||95.0|||||Wilcoxon signed-rank|||||||0.36
91716091|NCT01939314|183322999|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|-13.0|27.1||||||||27.1|-13.0|
91716092|NCT01939314|183323001|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|||||TWO_SIDED|95.0|2.6|43.6||||||||43.6|2.6|
91716093|NCT03311945|183323025|OTHER||||||||||||||||||This was a single-arm study without a comparator group; therefore, no formal hypothesis testing was conducted. The primary endpoint-therapeutic failure at 48 weeks-was analyzed descriptively. The proportion of participants experiencing therapeutic failure was calculated for both the intention-to-treat (ITT) and on-treatment (OT) populations. Exact binomial (Clopper-Pearson) 95% confidence intervals were used to estimate the failure rates.|||
91716094|NCT03839394|183323045|OTHER|||||||0.012|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.012
91716095|NCT03839394|183323046|OTHER|||||||0.05|||||||Z-test of Proportions|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.05
91716096|NCT03839394|183323047|OTHER|||||||0.75|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.750
91716097|NCT03839394|183323048|OTHER|||||||0.86|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.860
91716098|NCT03839394|183323049|OTHER|||||||0.76|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.760
91716099|NCT00418028|183323072|NON_INFERIORITY_OR_EQUIVALENCE|"If we assume that the non-inferiority level is up to 15% lower (equivalent to a median progression-free time of 3 months), for a one-sided error α=0.05, and 80% power, are necessary 88 patients per group.~Considering an dropout rate of around 10%, the number of patients would be 98 per group."|Hazard Ratio (HR)|1.3||||0.1224|TWO_SIDED|95.0|0.9|1.7|||Log Rank|||||1.7|0.9|0.1224
91716100|NCT00418028|183323073|SUPERIORITY|||||||0.8269|||||||Chi-squared|||||||0.8269
91716101|NCT00418028|183323074|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5703|TWO_SIDED|95.0|0.67|2.07|||Log Rank|||||2.07|0.67|0.5703
91716102|NCT00418028|183323075|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4676|TWO_SIDED|95.0|0.83|1.5|||Log Rank|||||1.50|0.83|0.4676
91716103|NCT00418028|183323076|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5688|TWO_SIDED|95.0|0.66|1.25|||Log Rank|||||1.25|0.66|0.5688
91716104|NCT00418028|183323077|SUPERIORITY|||||||0.4984|||||||Chi-squared|||||||0.4984
91639544|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.6||||0.9999|TWO_SIDED|95.0|71.7|136.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||136|71.7|0.9999
91639545|NCT05664672|183170869|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|80.5||||0.3025|TWO_SIDED|95.0|57.8|112.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||112|57.8|0.3025
91639546|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.7|||<|0.0001|TWO_SIDED|95.0|17.0|30.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||30.4|17.0|<.0001
91673231|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0009|TWO_SIDED|95.0|-0.58|-0.15|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.15|-0.58|0.0009
91673232|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.48|-1.00|<.0001
91673233|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.77|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.77|0.0001
91673234|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.06|-0.5|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.06|<.0001
91673235|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.77|-0.21|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.21|-0.77|0.0006
91673236|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.2|-0.62|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.62|-1.20|<.0001
91673237|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.47|-1.06|<.0001
91673238|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.59|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.59|-1.20|<.0001
91673239|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.64|-1.25|<.0001
91526468|NCT01087996|182928084|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Chi-squared|||||||0.55
91639547|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.6|21.6|<.0001
91716105|NCT00418028|183323078|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.2556|TWO_SIDED|95.0|0.88|1.63|||Log Rank|||||1.63|0.88|0.2556
91716106|NCT05630196|183323120|SUPERIORITY||Posterior Mean Difference|0.39|||||TWO_SIDED|95.0|-0.22|1.0|||||Posterior mean difference with 95% credible interval is reported.|||1.00|-0.22|
91716107|NCT05630196|183323121|SUPERIORITY||Posterior Mean Difference|1.16|||||TWO_SIDED|95.0|-0.44|2.77|||||Posterior mean difference with 95% credible interval is reported.|||2.77|-0.44|
91639548|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|27.5|||<|0.0001|TWO_SIDED|95.0|20.8|36.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.2|20.8|<.0001
91716108|NCT05630196|183323122|SUPERIORITY||Posterior Mean Difference|0.22|||||TWO_SIDED|95.0|-0.23|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.23|
91716109|NCT05630196|183323123|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.13|1.18|||||Posterior mean difference with 95% credible interval is reported.|||1.18|-0.13|
91639549|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.7|||<|0.0001|TWO_SIDED|95.0|21.4|38.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||38.4|21.4|<.0001
91639550|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|79.4||||0.1843|TWO_SIDED|95.0|58.6|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|58.6|0.1843
91639551|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.1||||0.9994|TWO_SIDED|95.0|73.9|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|73.9|0.9994
91639552|NCT05664672|183170870|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|95.9||||0.9891|TWO_SIDED|95.0|71.4|129.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||129|71.4|0.9891
91639553|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.3|||<|0.0001|TWO_SIDED|95.0|30.4|45.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.7|30.4|<.0001
91639554|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|44.0|||<|0.0001|TWO_SIDED|95.0|36.5|53.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.1|36.5|<.0001
91639555|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|41.8|||<|0.0001|TWO_SIDED|95.0|34.4|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|34.4|<.0001
91639556|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|42.9|||<|0.0001|TWO_SIDED|95.0|34.9|52.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.7|34.9|<.0001
91639557|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.9||||0.3027|TWO_SIDED|95.0|70.0|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|70.0|0.3027
91639558|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9926|TWO_SIDED|95.0|83.9|125.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||125|83.9|0.9926
91639559|NCT05664672|183170871|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|97.5||||0.9938|TWO_SIDED|95.0|79.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|79.1|0.9938
91639560|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|46.3|||<|0.0001|TWO_SIDED|95.0|39.5|54.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.4|39.5|<.0001
91526469|NCT01807650|182928097|SUPERIORITY_OR_OTHER||||||=|0.0232||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments."||||=0.0232
91526470|NCT01807650|182928101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_DEVIATION|17.8|=|0.0005|TWO_SIDED|95.0|2.7|9.4||Day 7|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|2.7|=0.0005
91639561|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|55.6|||<|0.0001|TWO_SIDED|95.0|48.0|64.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.4|48.0|<.0001
91639562|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.7|||<|0.0001|TWO_SIDED|95.0|45.2|61.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||61.5|45.2|<.0001
91639563|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|54.9|||<|0.0001|TWO_SIDED|95.0|46.7|64.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.5|46.7|<.0001
91639564|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|84.4||||0.0504|TWO_SIDED|95.0|71.2|100.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||100|71.2|0.0504
91639565|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||0.9988|TWO_SIDED|95.0|86.4|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|86.4|0.9988
91639566|NCT05664672|183170872|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|96.0||||0.9238|TWO_SIDED|95.0|81.4|113.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||113|81.4|0.9238
91639567|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|3.71|||<|0.0001|TWO_SIDED|95.0|1.88|7.31|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.31|1.88|<.0001
91639568|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.25|||<|0.0001|TWO_SIDED|95.0|2.28|7.93|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.93|2.28|<.0001
91639569|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.24|||<|0.0001|TWO_SIDED|95.0|2.2|8.14|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.14|2.20|<.0001
91639570|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.4|||<|0.0001|TWO_SIDED|95.0|3.22|12.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.7|3.22|<.0001
91639571|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|57.9||||0.184|TWO_SIDED|95.0|28.3|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|28.3|0.1840
91639572|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.4||||0.3552|TWO_SIDED|95.0|34.0|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|34.0|0.3552
91716110|NCT05630196|183323124|SUPERIORITY||Posterior Mean Difference|4.2|||||TWO_SIDED|95.0|-3.51|11.87|||||Posterior mean difference with 95% credible interval is reported.|||11.87|-3.51|
91716111|NCT05630196|183323125|SUPERIORITY||Posterior Mean Difference|-0.34|||||TWO_SIDED|95.0|-0.74|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.74|
91639573|NCT05664672|183170873|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.2||||0.381|TWO_SIDED|95.0|33.0|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|33.0|0.3810
91716112|NCT05630196|183323126|SUPERIORITY||Posterior Mean Difference|-11.11|||||TWO_SIDED|95.0|-159.85|136.77|||||Posterior mean difference with 95% credible interval is reported.|||136.77|-159.85|
91716113|NCT05630196|183323127|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
91716114|NCT03438266|183323128|NON_INFERIORITY|If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.05|0.25|||||The 95% CI is based on the paired t-test.|Change from Baseline at Month 1||0.25|-0.05|
91526471|NCT01807650|182928101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|16.9|=|0.0002|TWO_SIDED|95.0|3.0|9.4||Day 10|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|3.0|=0.0002
91639574|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.8|||<|0.0001|TWO_SIDED|95.0|13.0|21.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||21.8|13.0|<.0001
91639575|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|20.5|||<|0.0001|TWO_SIDED|95.0|16.2|25.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.9|16.2|<.0001
91639576|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.3|23.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.4|14.3|<.0001
91639577|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.1|13.7|<.0001
91639578|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.5||||0.9589|TWO_SIDED|95.0|72.0|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|72.0|0.9589
91639579|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|115.0||||0.4442|TWO_SIDED|95.0|89.3|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|89.3|0.4442
91639580|NCT05664672|183170874|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9975|TWO_SIDED|95.0|78.8|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|78.8|0.9975
91639581|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|36.5|||<|0.0001|TWO_SIDED|95.0|23.9|55.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||55.6|23.9|<.0001
91639582|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|39.9|||<|0.0001|TWO_SIDED|95.0|27.1|59.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.0|27.1|<.0001
91639583|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|30.2|||<|0.0001|TWO_SIDED|95.0|20.1|45.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.5|20.1|<.0001
91639584|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|48.9||||0.0002|TWO_SIDED|95.0|31.9|75.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||75.0|31.9|0.0002
91639585|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|74.5||||0.2938|TWO_SIDED|95.0|47.6|117.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||117|47.6|0.2938
91639586|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|81.6||||0.5552|TWO_SIDED|95.0|53.7|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|53.7|0.5552
91639587|NCT05664672|183170875|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|61.7||||0.0254|TWO_SIDED|95.0|39.9|95.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||95.5|39.9|0.0254
91639588|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.1|||<|0.0001|TWO_SIDED|95.0|40.4|67.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||67.1|40.4|<.0001
91639589|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.3|||<|0.0001|TWO_SIDED|95.0|39.0|62.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||62.2|39.0|<.0001
91639590|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|40.8|||<|0.0001|TWO_SIDED|95.0|32.0|52.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.1|32.0|<.0001
91639591|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|45.9|||<|0.0001|TWO_SIDED|95.0|35.7|59.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.2|35.7|<.0001
91673240|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.93|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.93|0.0001
91673241|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.5|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.13|<.0001
91673242|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.05|<.0001
91673243|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.44|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.44|-1.10|<.0001
91673244|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.06|<.0001
91673245|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.13|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.46|-1.13|<.0001
91716115|NCT03438266|183323129|OTHER||Percentage Difference|-1.7|||||TWO_SIDED|95.0|-7.31|3.98||||||||3.98|-7.31|
91716116|NCT03256578|183323215|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
91716117|NCT03256578|183323216|SUPERIORITY|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
91716118|NCT03256578|183323217|SUPERIORITY|||||||0.847|||||||Wilcoxon (Mann-Whitney)|||||||0.847
91716119|NCT03256578|183323218|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
91716120|NCT03256578|183323219|SUPERIORITY|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
91716121|NCT03256578|183323220|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
91716122|NCT03256578|183323221|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||||||0.656
91716123|NCT03256578|183323222|SUPERIORITY|||||||0.434|||||||Wilcoxon (Mann-Whitney)|||||||0.434
91716124|NCT03256578|183323223|SUPERIORITY|||||||0.903|||||||Wilcoxon (Mann-Whitney)|||||||0.903
91716125|NCT03256578|183323224|SUPERIORITY|||||||0.699|||||||Chi-squared|||||||0.699
91716126|NCT03256578|183323225|SUPERIORITY|||||||0.231|||||||Chi-squared|||||||0.231
91716127|NCT03256578|183323226|SUPERIORITY||Risk Ratio (RR)|0.593||||0.283|TWO_SIDED|95.0|0.225|1.561|||Chi-squared|||||1.561|0.225|0.283
91639592|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.5817|TWO_SIDED|95.0|86.8|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|86.8|0.5817
91639593|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.8852|TWO_SIDED|95.0|83.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||138|83.7|0.8852
91716128|NCT03256578|183323227|SUPERIORITY||Risk Ratio (RR)|1.864||||0.168|TWO_SIDED|95.0|0.756|4.599|||Chi-squared|||||4.599|0.756|0.168
91716129|NCT03256578|183323228|SUPERIORITY||Risk Ratio (RR)|0.67||||0.024|TWO_SIDED|95.0|0.474|0.947|||Chi-squared|||||0.947|0.474|0.024
91639594|NCT05664672|183170876|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.9||||0.607|TWO_SIDED|95.0|68.7|115.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||115|68.7|0.6070
91716130|NCT03256578|183323229|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
91716131|NCT03256578|183323230|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||||||0.342
91716132|NCT03256578|183323231|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
91716133|NCT03256578|183323233|SUPERIORITY||Risk Ratio (RR)|1.059||||0.518|TWO_SIDED|95.0|0.854|1.313|||Chi-squared|||||1.313|0.854|0.518
91716134|NCT03256578|183323234|SUPERIORITY||Risk Ratio (RR)|0.951||||0.855|TWO_SIDED|95.0|0.555|1.629|||Chi-squared|||||1.629|0.555|0.855
91716135|NCT03256578|183323235|SUPERIORITY||Risk Ratio (RR)|0.994||||0.524|TWO_SIDED|95.0|0.834|1.186|||Chi-squared|||||1.186|0.834|0.524
91716136|NCT03256578|183323236|SUPERIORITY||Risk Ratio (RR)|0.649||||0.28|TWO_SIDED|95.0|0.294|1.434|||Chi-squared|||||1.434|0.294|0.280
91716137|NCT03256578|183323237|SUPERIORITY||Risk Ratio (RR)|1.393||||0.339|TWO_SIDED|95.0|0.703|2.76|||Chi-squared|||||2.760|0.703|0.339
91716138|NCT03256578|183323238|SUPERIORITY|||||||0.486|||||||Chi-squared|||||||0.486
91716139|NCT03256578|183323239|SUPERIORITY|||||||0.655|||||||Chi-squared|||||||0.655
91716140|NCT03256578|183323240|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.99|1.02|||Chi-squared|||||1.02|0.99|1.00
91716141|NCT05428436|183323241|OTHER||gMean ratio|121.12|||||TWO_SIDED|90.0|86.14|170.3|||||gMean ratio: T1/R. Intra-individual Geometric coefficient of variation \[%\] = 78.5.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||170.30|86.14|
91716142|NCT05428436|183323241|OTHER||gMean ratio|108.13|||||TWO_SIDED|90.0|76.68|152.48|||||gMean ratio: T2/T1. Intra-individual Geometric coefficient of variation \[%\] = 78.5.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||152.48|76.68|
91716143|NCT05428436|183323242|OTHER||gMean ratio|122.01|||||TWO_SIDED|90.0|79.25|187.84|||||gMean ratio: T1/R. Intra-individual Geometric coefficient of variation \[%\] = 104.0.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment (restricted to the two formulation groups (T1 \& R)). The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.84|79.25|
91716144|NCT05428436|183323242|OTHER||gMean ratio|108.56|||||TWO_SIDED|90.0|104.33|112.97|||||gMean ratio: T2/T1. Intra-individual Geometric coefficient of variation \[%\] = 7.8.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment (restricted to the two treatment groups (T1 \& T2)). The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.97|104.33|
91716145|NCT05428436|183323243|OTHER||gMean ratio|118.0|||||TWO_SIDED|90.0|85.82|162.25|||||gMean ratio: T1/R. Intra-individual Geometric coefficient of variation \[%\] = 72.2.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||162.25|85.82|
91716146|NCT05428436|183323243|OTHER||gMean ratio|87.94|||||TWO_SIDED|90.0|63.77|121.28|||||gMean ratio: T2/T1. Intra-individual Geometric coefficient of variation \[%\] = 72.2.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||121.28|63.77|
91716147|NCT05428436|183323244|OTHER||gMean ratio|115.63|||||TWO_SIDED|90.0|77.64|172.22|||||gMean ratio: T1/R. Intra-individual Geometric coefficient of variation \[%\] = 93.3.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment (restricted to the two formulation groups (T1 \& R)). The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||172.22|77.64|
91792981|NCT03505671|183463483|OTHER|||||||0.22||||||P value for cross sectional area for median data|ANCOVA|||||||0.22
91792982|NCT03505671|183463484|OTHER|||||||0.2||||||P value for amplitude - sural data|ANCOVA|||||||0.20
91792983|NCT03505671|183463484|OTHER|||||||0.28||||||P value for amplitude - tibial, ankle|ANCOVA|||||||0.28
91639595|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.2|||<|0.0001|TWO_SIDED|95.0|5.44|32.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||32.0|5.44|<.0001
91639596|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.8|||<|0.0001|TWO_SIDED|95.0|10.7|53.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.3|10.7|<.0001
91639597|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.7||||0.0003|TWO_SIDED|95.0|10.6|57.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||57.4|10.6|0.0003
91639598|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.3||||0.0002|TWO_SIDED|95.0|9.21|54.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.1|9.21|0.0002
91673246|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.87|-0.16|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.87|0.0040
91673247|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.98|0.0005
91673248|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.33|-1.06|0.0002
91673249|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.32|-1.05|0.0002
91673250|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.2||0.0506|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.00|-0.78|0.0506
91639599|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|59.1||||0.428|TWO_SIDED|95.0|23.3|150.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||150|23.3|0.4280
91639600|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.999|TWO_SIDED|95.0|44.8|255.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||255|44.8|0.9990
91639601|NCT05664672|183170877|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|110.0||||0.9958|TWO_SIDED|95.0|44.9|272.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||272|44.9|0.9958
91673251|NCT02709486|183241158|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.0086|TWO_SIDED|95.0|-0.91|-0.13|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.91|0.0086
91716148|NCT05428436|183323244|OTHER||gMean ratio|90.74|||||TWO_SIDED|90.0|80.82|101.87|||||gMean ratio: T2/T1. Intra-individual Geometric coefficient of variation \[%\] = 23.0.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment (restricted to the two treatment groups (T1 \& T2)). The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||101.87|80.82|
91792984|NCT03505671|183463484|OTHER|||||||0.13||||||P value for amplitude tibial, pop fossa|ANCOVA|||||||0.13
91639602|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|-50.8|||<|0.0001|TWO_SIDED|95.0|-77.7|-23.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-23.9|-77.7|<.0001
91639603|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|-45.0|||<|0.0001|TWO_SIDED|95.0|-69.6|-20.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-20.3|-69.6|<.0001
91639604|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|-42.3||||0.0003|TWO_SIDED|95.0|-68.2|-16.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-16.5|-68.2|0.0003
91639605|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|-44.8||||0.0004|TWO_SIDED|95.0|-72.6|-17.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-17.0|-72.6|0.0004
91639606|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|-6.05||||0.9551|TWO_SIDED|95.0|-35.2|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||23.1|-35.2|0.9551
91639607|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|-0.198||||1|TWO_SIDED|95.0|-27.3|26.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||26.9|-27.3|1.0000
91673252|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.07|<.0001
91673253|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.94|<.0001
91639608|NCT05664672|183170878|SUPERIORITY||Ratio of geometric LS means|2.48||||0.9981|TWO_SIDED|95.0|-25.6|30.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||30.6|-25.6|0.9981
91639609|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|31.7|||<|0.0001|TWO_SIDED|95.0|18.7|53.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.9|18.7|<.0001
91639610|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.5|||<|0.0001|TWO_SIDED|95.0|17.6|46.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||46.2|17.6|<.0001
91639611|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.3|||<|0.0001|TWO_SIDED|95.0|14.7|40.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.2|14.7|<.0001
91639612|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|16.6|47.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||47.7|16.6|<.0001
91716149|NCT05428436|183323245|OTHER||gMean ratio|93.79|||||TWO_SIDED|90.0|90.49|97.21|||||gMean ratio: T1/R. Intra-individual Geometric coefficient of variation \[%\] = 7.1.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||97.21|90.49|
91792985|NCT03505671|183463484|OTHER|||||||0.71||||||P value for amplitude median, wrist|ANCOVA|||||||0.71
91716150|NCT05428436|183323245|OTHER||gMean ratio|109.51|||||TWO_SIDED|90.0|105.72|113.44|||||gMean ratio: T2/T1. Intra-individual Geometric coefficient of variation \[%\] = 7.1.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||113.44|105.72|
91716151|NCT05428436|183323246|OTHER||gMean ratio|95.01|||||TWO_SIDED|90.0|91.39|98.77|||||gMean ratio: T1/R. Intra-individual Geometric coefficient of variation \[%\] = 7.5.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment (restricted to the two formulation groups (T1 \& R)). The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||98.77|91.39|
91716152|NCT05428436|183323246|OTHER||gMean ratio|108.3|||||TWO_SIDED|90.0|103.9|112.89|||||gMean ratio: T2/T1. Intra-individual Geometric coefficient of variation \[%\] = 8.2.|ANOVA model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment (restricted to the two treatment groups (T1 \& T2)). The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.89|103.90|
91716153|NCT03964207|183323247|SUPERIORITY||Difference of LSmeans|-5.28||||0.007|TWO_SIDED|95.0|-9.07|-1.48|||Mixed-effects Model||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||-1.48|-9.07|0.007
91716154|NCT03964207|183323248|SUPERIORITY||Difference of LSmeans|-4.14||||0.024|TWO_SIDED|95.0|-7.72|-0.56|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect||-0.56|-7.72|0.024
91716155|NCT03964207|183323249|SUPERIORITY||Difference rate (%)|13.0||||0.249|||||||Chi-square test||The Difference rate was calculated as: value from the test treatment group - value from the comparator treatment group.|Chi-squared test was used to analyze proportion of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8. All participants have used both treatments at this point: Handihaler (4 weeks) and Respimat (4 weeks).||||0.249
91716156|NCT03964207|183323250|SUPERIORITY||Difference of LSmeans|-4.72||||0.057|TWO_SIDED|95.0|-9.59|0.15|||The mixed model for repeated measures||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||0.15|-9.59|0.057
91485585|NCT03438383|182844269|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.83||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.83
91716157|NCT03964207|183323251|SUPERIORITY||Difference of LSmeans|-4.38||||0.347|TWO_SIDED|95.0|-13.63|4.86|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||4.86|-13.63|0.347
91716158|NCT02337062|183323265|SUPERIORITY||||||<|0.001||||||The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test.||||<0.001
91716159|NCT02337062|183323266|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
91716160|NCT02337062|183323267|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
91716161|NCT02337062|183323268|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
91716162|NCT02337062|183323269|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91716163|NCT02337062|183323270|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91716164|NCT00433836|183323290|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority delta of 3.5 mm Hg|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.8|1.17|||ANOVA|||||1.17|-3.80|
91716165|NCT01240382|183323299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Median Difference (Final Values)|-0.03||||||95.0|-0.405|0.338|||l|||||0.338|-0.405|
91716166|NCT01240382|183323300|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.67||||0.01||95.0|-1.18|-0.67|||t-test, 2 sided|||||-0.67|-1.18|0.010
91716167|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.855|||||TWO_SIDED|90.0|0.799|0.914|||ANCOVA||AUC (0-inf) comparison|||0.914|0.799|
91716168|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.677|||||TWO_SIDED|90.0|0.635|0.721|||ANCOVA||AUC (0-inf) comparision|||0.721|0.635|
91716169|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.637|||||TWO_SIDED|90.0|0.594|0.682|||ANCOVA||AUC (0-inf) comparision|||0.682|0.594|
91716170|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.803|||||TWO_SIDED|90.0|0.747|0.864|||ANCOVA||AUC (0-24) comparision|||0.864|0.747|
91716171|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.608|||||TWO_SIDED|90.0|0.566|0.655|||ANOVA||AUC (0-24) comparision|||0.655|0.566|
91716172|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.557|||||TWO_SIDED|90.0|0.518|0.599|||ANCOVA||AUC (0-24) comparision|||0.599|0.518|
91792986|NCT03505671|183463484|OTHER|||||||0.46||||||P value for amplitude, median, elbow|ANCOVA|||||||0.46
91639613|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.9511|TWO_SIDED|95.0|64.7|197.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||197|64.7|0.9511
91639614|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|60.4|170.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||170|60.4|1.0000
91639615|NCT05664672|183170879|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.5||||0.9003|TWO_SIDED|95.0|50.6|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|50.6|0.9003
91639616|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|46.4|||<|0.0001|TWO_SIDED|95.0|37.1|58.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||58.0|37.1|<.0001
91639617|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|43.1|||<|0.0001|TWO_SIDED|95.0|35.1|52.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||52.9|35.1|<.0001
91639618|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|44.1|||<|0.0001|TWO_SIDED|95.0|35.5|54.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||54.6|35.5|<.0001
91639619|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|39.1|||<|0.0001|TWO_SIDED|95.0|31.0|49.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||49.4|31.0|<.0001
91639620|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|119.0||||0.2351|TWO_SIDED|95.0|93.2|151.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||151|93.2|0.2351
91639621|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|110.0||||0.657|TWO_SIDED|95.0|87.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||138|87.7|0.6570
91673254|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.03|-0.41|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.03|<.0001
91639622|NCT05664672|183170880|SUPERIORITY||Ratio of geometric LS means|113.0||||0.5112|TWO_SIDED|95.0|89.1|142.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||142|89.1|0.5112
91639623|NCT00643851|183170913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.1243|<|0.0001|TWO_SIDED|95.0|-1.11|-0.62||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET was superior to both controls.|ANCOVA|||||-0.62|-1.11|<0.0001
91673255|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.15|<.0001
91673256|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.91|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.91|0.0004
91716173|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.819|||||TWO_SIDED|90.0|0.766|0.876|||ANCOVA||AUC (0-t) comparision|||0.876|0.766|
91673257|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.31|<.0001
91673258|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.14|<.0001
91673259|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.18|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.18|<.0001
91716174|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.636|||||TWO_SIDED|90.0|0.595|0.68|||ANCOVA||AUC (0-t) comparision|||0.680|0.595|
91716175|NCT02634073|183323388|SUPERIORITY_OR_OTHER||Ratio|0.585|||||TWO_SIDED|90.0|0.548|0.626|||ANCOVA||AUC (0-t) comparision|||0.626|0.548|
91716176|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|0.993|||||TWO_SIDED|90.0|0.916|1.08|||ANCOVA||C24 comparison|||1.08|0.916|
91485586|NCT03438383|182844269|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.37||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.37
91673260|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-1.00|0.0002
91673261|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.12|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.12|<.0001
91673262|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0013|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.24|-0.99|0.0013
91673263|NCT02709486|183241160|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.25|-0.5|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.25|<.0001
91639624|NCT00643851|183170913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1245|<|0.0001|TWO_SIDED|95.0|-0.94|-0.45||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.45|-0.94|<0.0001
91639625|NCT00643851|183170914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|3.883|<|0.0001|TWO_SIDED|95.0|-26.7|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-11.4|-26.7|<0.0001
91716177|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|90.0|1.03|1.21|||ANCOVA||C24 comparision|||1.21|1.03|
91716178|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|90.0|1.0|1.18|||ANCOVA||C24 comparision|||1.18|1.000|
91716179|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56|||ANCOVA||Ct comparision|||1.56|1.13|
91716180|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|1.46|||||TWO_SIDED|90.0|1.25|1.71|||ANCOVA||Ct comparision|||1.71|1.25|
91716181|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|1.39|||||TWO_SIDED|90.0|1.18|1.63|||ANCOVA||Ct comparision|||1.63|1.18|
91716182|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|0.724|||||TWO_SIDED|90.0|0.657|0.798|||ANCOVA||Cmax comparision|||0.798|0.657|
91716183|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|0.479|||||TWO_SIDED|90.0|0.434|0.527|||ANCOVA||Cmax comparision|||0.527|0.434|
91716184|NCT02634073|183323389|SUPERIORITY_OR_OTHER||Ratio|0.454|||||TWO_SIDED|90.0|0.412|0.5|||ANCOVA||Cmax comparision|||0.500|0.412|
91716185|NCT02634073|183323390|SUPERIORITY_OR_OTHER||Ratio|1.37|||||TWO_SIDED|90.0|1.11|1.69|||ANCOVA|||||1.69|1.11|
91716186|NCT02634073|183323390|SUPERIORITY_OR_OTHER||Ratio|1.53|||||TWO_SIDED|90.0|1.25|1.88|||ANCOVA|||||1.88|1.25|
91716187|NCT02634073|183323390|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|90.0|1.04|1.61|||ANCOVA|||||1.61|1.04|
91716188|NCT02634073|183323391|SUPERIORITY_OR_OTHER||Ratio|1.17|||||TWO_SIDED|90.0|1.094|1.251|||ANCOVA|||||1.251|1.094|
91716189|NCT02634073|183323391|SUPERIORITY_OR_OTHER||Ratio|1.478|||||TWO_SIDED|90.0|1.386|1.576|||ANCOVA|||||1.576|1.386|
91716190|NCT02634073|183323391|SUPERIORITY_OR_OTHER||Ratio|1.571|||||TWO_SIDED|90.0|1.466|1.684|||ANCOVA|||||1.684|1.466|
91792987|NCT03505671|183463485|OTHER|||||||0.81||||||P value for latency sural data|ANCOVA|||||||0.81
91716191|NCT00705757|183323414|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||ANOVA|||One way ANOVA of Upper Lid||||0.769
91716192|NCT00705757|183323414|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of Lower Lid||||0.230
91716193|NCT00705757|183323414|SUPERIORITY_OR_OTHER|||||||0.851|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of cheek/face||||0.851
91716194|NCT05696392|183323419|OTHER|difference between the average sleep at baseline and Week 8||||||0.8357|||||||paired t-test|||||||0.8357
91716195|NCT05696392|183323420|OTHER|difference between the average sleep at baseline and Week 8||||||0.0001|||||||paired t-test|||||||0.0001
91716196|NCT03389620|183323448|NON_INFERIORITY|Based on previous literature indicating that the minimum clinical threshold for change in NRS pain score is 2 points, a non-inferiority margin of differential change between treatment arms of 2 points at the 2 month time point following the surgical procedure was specified, assuming the true difference between treatment arms is zero.||||||0.057|||||||t-test, 1 sided|||||||0.057
91716197|NCT03389620|183323449|SUPERIORITY|||||||0.376|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.376
91716198|NCT03389620|183323449|SUPERIORITY|||||||0.848|||||||t-test, 2 sided|||Baseline to 4 months||||0.848
91716199|NCT03389620|183323450|SUPERIORITY|||||||0.613|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.613
91716200|NCT03389620|183323450|SUPERIORITY|||||||0.565|||||||t-test, 2 sided|||Baseline to 2 months||||0.565
91716201|NCT03389620|183323450|SUPERIORITY|||||||0.958|||||||t-test, 2 sided|||Baseline to 4 months||||0.958
91526472|NCT01807650|182928101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|19.3|=|0.0028|TWO_SIDED|95.0|2.0|9.3||Day 14|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.0|=0.0028
91716202|NCT03389620|183323451|SUPERIORITY|||||||0.287|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.287
91716203|NCT03389620|183323451|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|||Baseline to 2 months||||0.365
91716204|NCT03389620|183323451|SUPERIORITY|||||||0.867|||||||t-test, 2 sided|||Baseline to 4 months||||0.867
91716205|NCT03389620|183323452|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.311
91716206|NCT03389620|183323452|SUPERIORITY|||||||0.377|||||||t-test, 2 sided|||Baseline to 2 months||||0.377
91716207|NCT03389620|183323452|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||Baseline to 4 months||||0.668
91716208|NCT03389620|183323453|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.794
91716209|NCT03389620|183323453|SUPERIORITY|||||||0.843|||||||t-test, 2 sided|||Baseline to 2 months||||0.843
91716210|NCT03389620|183323453|SUPERIORITY|||||||0.713|||||||t-test, 2 sided|||Baseline to 4 months||||0.713
91716211|NCT03389620|183323454|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.177
91716212|NCT03389620|183323454|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||Baseline to 2 months||||0.325
91716213|NCT03389620|183323454|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||Baseline to 4 months||||0.505
91716214|NCT03389620|183323455|SUPERIORITY|||||||0.811|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.811
91716215|NCT03389620|183323455|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||Baseline to 2 months||||0.325
91716216|NCT03389620|183323455|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||Baseline to 4 months||||0.674
91716217|NCT03389620|183323456|SUPERIORITY|||||||0.903|||||||t-test, 2 sided|||Baseline to 2 weeks||||0.903
91716218|NCT03389620|183323456|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Baseline to 2 months||||0.500
91716219|NCT03389620|183323456|SUPERIORITY|||||||0.716|||||||t-test, 2 sided|||Baseline to 4 months||||0.716
91716220|NCT03389620|183323457|SUPERIORITY|||||||0.461|||||||Fisher Exact|||Immediately post-procedure||||0.461
91716221|NCT03389620|183323457|SUPERIORITY|||||||1|||||||Fisher Exact|||2 days post procedure||||1.00
91716222|NCT06077773|183323488|SUPERIORITY||Least Square Mean Difference (LSMD)|1.99|STANDARD_ERROR_OF_MEAN|2.38||0.4059|TWO_SIDED|90.0|-1.96|5.94||MMRM=mixed effects model for repeated measures|MMRM|The p-value was based on the treatment group by week interaction term for the visit of interest.|LSMD = EP262 minus placebo|||5.94|-1.96|0.4059
91716223|NCT06077773|183323488|SUPERIORITY||LSMD|-1.53|STANDARD_ERROR_OF_MEAN|2.385||0.5213|TWO_SIDED|90.0|-5.49|2.42||The p-value was based on the treatment group by week interaction term for the visit of interest.|MMRM||LSMD = EP262 minus placebo|||2.42|-5.49|0.5213
91716224|NCT03834506|183323496|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1677|TWO_SIDED|95.0|0.78|1.09||One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||1.09|0.78|0.1677
91716225|NCT03834506|183323497|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0335|TWO_SIDED|95.0|0.71|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.71|0.0335
91716226|NCT03834506|183323498|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0331|TWO_SIDED|95.0|0.74|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.74|0.0331
91716227|NCT03834506|183323500|OTHER||Percent Difference|-1.8||||0.6545|TWO_SIDED|95.0|-10.7|7.1||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||7.1|-10.7|0.6545
91716228|NCT03834506|183323502|OTHER||Hazard Ratio (HR)|1.05||||0.6178|TWO_SIDED|95.0|0.77|1.43|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.43|0.77|0.6178
91792988|NCT03505671|183463485|OTHER|||||||0.76||||||P value for latency tibial, ankle data|ANCOVA|||||||0.76
91716229|NCT03834506|183323503|OTHER||Hazard Ratio (HR)|1.54||||0.9788|TWO_SIDED|95.0|1.01|2.33|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||2.33|1.01|0.9788
91639626|NCT00643851|183170914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|3.897|<|0.0001|TWO_SIDED|95.0|-35.1|-19.8||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-19.8|-35.1|<0.0001
91639627|NCT00643851|183170915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.9|STANDARD_ERROR_OF_MEAN|4.633|<|0.0001|TWO_SIDED|95.0|20.8|39.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|modified logistic regression|||||39.0|20.8|<0.0001
91639628|NCT00643851|183170915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|4.947||0.0003|TWO_SIDED|95.0|8.1|27.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||27.4|8.1|0.0003
91639629|NCT00643851|183170916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.1938|<|0.0001|TWO_SIDED|95.0|-1.72|-0.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.96|-1.72|<0.0001
91639630|NCT00643851|183170916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.1912|<|0.0001|TWO_SIDED|95.0|-1.57|-0.82||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.82|-1.57|<0.0001
91639631|NCT00643851|183170917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3388||0.8769|TWO_SIDED|95.0|-0.72|0.61||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.61|-0.72|0.8769
91639632|NCT00643851|183170917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3399|<|0.0001|TWO_SIDED|95.0|-2.04|-0.71||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.71|-2.04|<0.0001
91639633|NCT00643851|183170918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.4191|||TWO_SIDED|95.0|-0.98|0.66||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.66|-0.98|
91639634|NCT00643851|183170918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.4201|||TWO_SIDED|95.0|-2.4|-0.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.74|-2.40|
91639635|NCT01441882|183170949|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.0106|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (lymph node size).||||0.0106
91639636|NCT01441882|183170949|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.1986|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (Absolute Lymphocyte Count (ALC)).||||0.19860
91639637|NCT01441882|183170949|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.5167|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (spleen size).||||0.5167
91639638|NCT01694849|183170979|SUPERIORITY||Odds Ratio (OR)|1.092||||0.8539|TWO_SIDED|95.0|0.427|2.795||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.795|0.427|0.8539
91639639|NCT01694849|183170979|SUPERIORITY||Odds Ratio (OR)|0.897||||0.816|TWO_SIDED|95.0|0.361|2.232||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.232|0.361|0.8160
91639640|NCT01694849|183170980|SUPERIORITY||difference in least square mean change|-0.27||||0.225|TWO_SIDED|95.0|-0.75|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.75|0.225
91639641|NCT01694849|183170980|SUPERIORITY||Difference in least square mean change|-0.28||||0.254|TWO_SIDED|95.0|-0.76|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.76|0.254
91639642|NCT01694849|183170981|SUPERIORITY||Odds Ratio (OR)|1.073||||0.8586|TWO_SIDED|95.0|0.493|2.339|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score.|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.339|0.493|0.8586
91673264|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.45|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.45|-0.96|<.0001
91716230|NCT03834506|183323504|OTHER||Hazard Ratio (HR)|0.96||||0.297|TWO_SIDED|95.0|0.82|1.12|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.12|0.82|0.2970
91639643|NCT01694849|183170981|SUPERIORITY||Odds Ratio (OR)|1.601||||0.2265|TWO_SIDED|95.0|0.747|3.432|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.432|0.747|0.2265
91639644|NCT01694849|183170982|SUPERIORITY||Odds Ratio (OR)|0.723||||0.5231|TWO_SIDED|95.0|0.267|1.958|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.958|0.267|0.5231
91639645|NCT01694849|183170982|SUPERIORITY||Odds Ratio (OR)|1.102||||0.8459|TWO_SIDED|95.0|0.415|2.924|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.924|0.415|0.8459
91639646|NCT01694849|183170983|SUPERIORITY||Odds Ratio (OR)|0.638||||0.5229|TWO_SIDED|95.0|0.161|2.529|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.529|0.161|0.5229
91639647|NCT01694849|183170983|SUPERIORITY||Odds Ratio (OR)|1.433||||0.5646|TWO_SIDED|95.0|0.421|4.875|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||4.875|.421|0.5646
91639648|NCT01694849|183170984|SUPERIORITY||Odds Ratio (OR)|0.382||||0.1983|TWO_SIDED|95.0|0.088|1.656|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.656|0.088|0.1983
91639649|NCT01694849|183170984|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.288|3.466|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.466|0.288|1.0000
91639650|NCT01694849|183170985|SUPERIORITY||Odds Ratio (OR)|0.653||||0.3543|TWO_SIDED|95.0|0.265|1.609|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.609|0.265|0.3543
91639651|NCT01694849|183170985|SUPERIORITY||Odds Ratio (OR)|1.27||||0.578|TWO_SIDED|95.0|0.547|2.953|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.953|0.547|0.5780
91639652|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|1.24||||0.711|TWO_SIDED|95.0|-5.33|7.81|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||7.81|-5.33|0.711
91639653|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-0.94||||0.78|TWO_SIDED|95.0|-7.58|5.7|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||5.7|-7.58|0.78
91639654|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-6.13||||0.221|TWO_SIDED|95.0|-15.97|3.71|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||3.71|-15.97|0.221
91639655|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-9.45||||0.062|TWO_SIDED|95.0|-19.4|0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||0.49|-19.4|0.062
91639656|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-23.02|||<|0.001|TWO_SIDED|95.0|-27.16|-18.88|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||-18.88|-27.16|<0.001
91639657|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-23.85|||<|0.001|TWO_SIDED|95.0|-28.04|2.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||2.12|-28.04|<0.001
91639658|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-31.41|||<|0.001|TWO_SIDED|95.0|-43.78|-19.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-19.05|-43.78|<0.001
91639659|NCT01694849|183170986|SUPERIORITY||Difference in least square mean change|-29.31|||<|0.001|TWO_SIDED|95.0|-41.84|-16.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-16.77|-41.84|<0.001
91639660|NCT01694849|183170987|SUPERIORITY||Difference in least square mean change|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.21|0.06|<0.001
91639661|NCT01694849|183170987|SUPERIORITY||Difference in least square mean change|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.26|0.11|<0.001
91639662|NCT01694849|183170988|SUPERIORITY||Difference in least square mean change|141.78||||0.095|TWO_SIDED|95.0|-24.99|308.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||308.55|-24.99|0.095
91639663|NCT01694849|183170988|SUPERIORITY||Difference in least square mean change|-70.57||||0.412|TWO_SIDED|95.0|-239.85|98.71||Baseline parameter value and presence of diabetes as random factors|Mixed Models Analysis||Standard error of the least square mean|||98.71|-239.85|0.412
91673265|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|95.0|-0.73|-0.21|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.73|0.0004
91673266|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.04|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.49|-1.04|<.0001
91673267|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.08|<.0001
91673268|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.90|<.0001
91673269|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.13|-0.56|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-1.13|<.0001
91673270|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.09|-0.47|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.09|<.0001
91673271|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.12|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.12|<.0001
91673272|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.95|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.95|0.0001
91673273|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
91673274|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.0015|TWO_SIDED|95.0|-0.89|-0.21|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.89|0.0015
91673275|NCT02709486|183241162|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.07|-0.39|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.07|<.0001
91673276|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.96|-0.38|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.38|-0.96|<.0001
91673277|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.67|-0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.67|0.0139
91792989|NCT03505671|183463485|OTHER|||||||0.24||||||P value for latency tibial, pop fossa|ANCOVA|||||||0.24
91792990|NCT03505671|183463485|OTHER|||||||0.2||||||P value for latency median wrist data|ANCOVA|||||||0.20
91792991|NCT03505671|183463485|OTHER|||||||0.51||||||P value for latency median elbow data|ANCOVA|||||||0.51
91639664|NCT01694849|183170989|SUPERIORITY||Difference in least square mean change|32.39||||0.592|TWO_SIDED|95.0|-86.63|151.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||151.42|-86.63|0.592
91639665|NCT01694849|183170989|SUPERIORITY||Difference in least square mean change|31.35||||0.61|TWO_SIDED|95.0|-89.42|152.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||152.12|-89.42|0.61
91639666|NCT01694849|183170990|SUPERIORITY||Difference in least square mean change|1.67||||0.459|TWO_SIDED|95.0|-2.77|6.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.11|-2.77|0.459
91639667|NCT01694849|183170990|SUPERIORITY||Difference in least square mean change|-0.67||||0.764|TWO_SIDED|95.0|-5.06|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|-5.06|0.764
91639668|NCT01694849|183170991|SUPERIORITY||Difference in least square mean change|-12.92||||0.466|TWO_SIDED|95.0|-47.79|21.95|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||21.95|-47.79|0.466
91639669|NCT01694849|183170991|SUPERIORITY||Difference in least square mean change|-5.82||||0.745|TWO_SIDED|95.0|-41.07|29.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||29.42|-41.07|0.745
91639670|NCT01694849|183170992|SUPERIORITY||Difference in least square mean change|-26.57||||0.018|TWO_SIDED|95.0|-48.59|-4.54|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-4.54|-48.59|0.018
91639671|NCT01694849|183170992|SUPERIORITY||Difference in least square mean change|-40.39|||<|0.001|TWO_SIDED|95.0|-62.61|-18.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-18.17|-62.61|<0.001
91639672|NCT01694849|183170992|SUPERIORITY||Difference in least square mean change|190.07||||0.101|TWO_SIDED|95.0|-37.38|417.52|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||417.52|-37.38|0.101
91639673|NCT01694849|183170992|SUPERIORITY||Difference in least square mean change|228.33||||0.052|TWO_SIDED|95.0|-2.16|458.82|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||458.82|-2.16|0.052
91639674|NCT01694849|183170993|SUPERIORITY||Difference in least square mean change|-0.14||||0.002|TWO_SIDED|95.0|-0.29|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.29|0.002
91639675|NCT01694849|183170993|SUPERIORITY||Difference in least square mean change|-0.24|||<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.15|-0.34|<0.001
91639676|NCT01694849|183170994|SUPERIORITY||Difference in least square mean change|-16.54||||0.203|TWO_SIDED|95.0|-42.07|8.98|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Hyaluronic acid||8.98|-42.07|0.203
91639677|NCT01694849|183170994|SUPERIORITY||Difference in least square mean change|-6.79||||0.603|TWO_SIDED|95.0|-32.49|18.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||18.9|-32.49|0.603
91639678|NCT01694849|183170994|SUPERIORITY||Difference in least square mean change|-0.73||||0.235|TWO_SIDED|95.0|-1.95|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.48|-1.95|0.235
91639679|NCT01694849|183170994|SUPERIORITY||Difference in least square mean change|-0.81||||0.193|TWO_SIDED|95.0|-2.04|0.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.41|-2.04|0.193
91639680|NCT01694849|183170994|SUPERIORITY||Difference in least square mean change|6.21||||0.348|TWO_SIDED|95.0|-6.81|19.22|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||19.22|-6.81|0.348
91639681|NCT01694849|183170994|SUPERIORITY||Difference in least square mean change|-14.66||||0.029|TWO_SIDED|95.0|-27.81|1.51|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||1.51|-27.81|0.029
91639682|NCT01694849|183170995|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.07|<0.001
91639683|NCT01694849|183170995|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.08|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.08|<0.001
91639684|NCT01694849|183170996|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
91639685|NCT01694849|183170996|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
91639686|NCT01694849|183170997|SUPERIORITY||Difference in least square mean change|0.06||||0.471|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.23|-0.11|0.471
91639687|NCT01694849|183170997|SUPERIORITY||Difference in least square mean change|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.42|0.005
91639688|NCT01694849|183170998|SUPERIORITY||Difference in least square mean change|-0.07||||0.457|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.27|0.457
91716231|NCT03834506|183323505|OTHER||Hazard Ratio (HR)|0.95||||0.2876|TWO_SIDED|95.0|0.78|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.15|0.78|0.2876
91639689|NCT01694849|183170998|SUPERIORITY||Difference in least square mean|-0.08||||0.428|TWO_SIDED|95.0|-0.28|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.28|0.428
91673278|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.13|<.0001
91673279|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.55|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.16|<.0001
91639690|NCT01694849|183170999|SUPERIORITY||Difference in least square mean change|-9.22|||<|0.001|TWO_SIDED|95.0|-13.19|-5.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.24|-13.19|<0.001
91673280|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.91|-0.27|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.91|0.0003
91673281|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.04|-0.4|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.04|<.0001
91673282|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
91673283|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.14|<.0001
91673284|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.98|0.0006
91673285|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.25|-0.96|0.0009
91673286|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0377|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.02|-0.78|0.0377
91792992|NCT03505671|183463486|OTHER|||||||0.98||||||P value for velocity sural data|ANCOVA|||||||0.98
91792993|NCT03505671|183463486|OTHER|||||||0.03||||||P value for velocity tibial data|ANCOVA|||||||0.03
91792994|NCT03505671|183463486|OTHER|||||||0.81||||||P value for velocity median data|ANCOVA|||||||0.81
91526473|NCT01807650|182928101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|STANDARD_DEVIATION|18.0|=|0.0009|TWO_SIDED|95.0|2.5|9.3||Day 18|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.5|=0.0009
91639691|NCT01694849|183170999|SUPERIORITY||Difference in least square mean change|-9.08|||<|0.001|TWO_SIDED|95.0|-13.12|-5.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.04|-13.12|<0.001
91639692|NCT01694849|183171000|SUPERIORITY||Difference in least square mean change|0.02||||0.531|TWO_SIDED|95.0|-0.05|0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.09|-0.05|0.531
91792995|NCT02038829|183463488|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0126|STANDARD_ERROR_OF_MEAN|0.0225||0.973|TWO_SIDED|95.0|-0.0318|0.0569||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0569|-0.0318|0.9730
91792996|NCT02038829|183463488|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0822|STANDARD_ERROR_OF_MEAN|0.0225||0.0014|TWO_SIDED|95.0|0.038|0.1264||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1264|0.0380|0.0014
91792997|NCT02038829|183463488|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0644|0.1532||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1532|0.0644|<0.0001
91716232|NCT04577794|183323508|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.981|TWO_SIDED|90.0|-1.7|1.7|||ANCOVA|||An analysis of covariance (ANCOVA) was used with a multiple imputation method to handle missing values, with treatment as fixed effect and baseline score as covariate.||1.7|-1.7|0.981
91716233|NCT00689338|183323516|SUPERIORITY_OR_OTHER||estimate of survival|53.8|||||TWO_SIDED|95.0|45.9|60.9|||Kaplan-Meier|||Kaplan-Meier estimate of survival at Day 90 (survivor function).||60.9|45.9|
91716234|NCT00078286|183323518|NON_INFERIORITY_OR_EQUIVALENCE|\*Power analysis already provided.|Difference in mean change score|-0.3||||0.89||95.0|||||Mixed Models Analysis|Significance was tested at p=.05.||A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.||||0.89
91792998|NCT02038829|183463488|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1375|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0931|0.1818||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation||0.1818|0.0931|<0.0001
91639693|NCT01694849|183171000|SUPERIORITY||Difference in least square mean change|-0.02||||0.638|TWO_SIDED|95.0|-0.08|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.08|0.638
91716235|NCT00078286|183323519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.78||95.0|||||Cochran-Mantel-Haenszel|||Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.||||.78
91716236|NCT00922636|183323654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.74||||0.008||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.008
91526474|NCT01807650|182928101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|15.8|=|0.0003|TWO_SIDED|95.0|2.6|8.6||Day 21|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||8.6|2.6|=0.0003
91639694|NCT01694849|183171001|SUPERIORITY||Difference in least square mean change|-0.14||||0.831|TWO_SIDED|95.0|-1.39|1.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.12|-1.39|0.831
91639695|NCT01694849|183171001|SUPERIORITY||Difference in least square mean change|0.2||||0.754|TWO_SIDED|95.0|-1.07|1.47|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.47|-1.07|0.754
91639696|NCT01694849|183171001|SUPERIORITY||Difference in least square mean change|-0.03||||0.848|TWO_SIDED|95.0|-0.36|0.3|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.3|-0.36|0.848
91639697|NCT01694849|183171001|SUPERIORITY||Difference in least square mean change|0.11||||0.511|TWO_SIDED|95.0|-0.22|0.45|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.45|-0.22|0.511
91639698|NCT01694849|183171002|SUPERIORITY||Difference in least square mean change|-2.83||||0.075|TWO_SIDED|95.0|-5.95|0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.29|-5.95|0.075
91639699|NCT01694849|183171002|SUPERIORITY||Difference in least square mean change|-1.11||||0.491|TWO_SIDED|95.0|-4.29|2.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.07|-4.29|0.491
91639700|NCT01694849|183171003|SUPERIORITY||Difference in least square mean change|-0.03||||0.393|TWO_SIDED|95.0|-0.1|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.1|0.393
91639701|NCT01694849|183171003|SUPERIORITY||Difference in least square mean change|-0.04||||0.289|TWO_SIDED|95.0|-0.11|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.11|0.289
91639702|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.21|-0.73|<0.001
91639703|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.55|||<|0.001|TWO_SIDED|95.0|-0.81|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.29|-0.81|<0.001
91639704|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.35||||0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.14|-0.56|0.001
91639705|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.43|||<|0.001|TWO_SIDED|95.0|-0.64|-0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.23|-0.64|<0.001
91639706|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.46|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.24|-0.67|<0.001
91639707|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.32|-0.75|<0.001
91639708|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|0.09||||0.005|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.15|0.03|0.005
91639709|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.17|0.05|<0.001
91639710|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.18|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.11|-0.26|<0.001
91639711|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.17|||<|0.001|TWO_SIDED|95.0|-0.25|-0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.09|-0.25|<0.001
91639712|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.2||||0.031|TWO_SIDED|95.0|-0.38|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.02|-0.38|0.031
91639713|NCT01694849|183171004|SUPERIORITY||Difference in least square mean change|-0.24||||0.009|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.06|-0.42|0.009
91639714|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|5.73||||0.038|TWO_SIDED|95.0|0.31|11.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||11.14|0.31|0.038
91639715|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|7.07||||0.012|TWO_SIDED|95.0|1.59|12.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||12.55|1.59|0.012
91673287|NCT02709486|183241164|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|-0.96|-0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.96|0.0019
91716237|NCT00922636|183323654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.04||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.006
91792999|NCT02038829|183463488|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1567|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.1121|0.2012||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2012|0.1121|<0.0001
91639716|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-12.41|||<|0.001|TWO_SIDED|95.0|-17.56|-7.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-7.25|-17.56|<0.001
91639717|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-9.61|||<|0.001|TWO_SIDED|95.0|-14.81|-4.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-4.41|-14.81|<0.001
91639718|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|3.55|||<|0.001|TWO_SIDED|95.0|2.14|4.96|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||4.96|2.14|<0.001
91639719|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|6.1|||<|0.001|TWO_SIDED|95.0|4.67|7.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||7.53|4.67|<0.001
91639720|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-2.27|||<|0.001|TWO_SIDED|95.0|-3.29|-1.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-1.25|-3.29|<0.001
91639721|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.5||||0.004|TWO_SIDED|95.0|-2.52|-0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-0.49|-2.52|0.004
91639722|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.78|||<|0.001|TWO_SIDED|95.0|-2.63|-0.92|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.92|-2.63|<0.001
91639723|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.15||||0.009|TWO_SIDED|95.0|-2.0|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.29|-2|0.009
91639724|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-0.46||||0.002|TWO_SIDED|95.0|-0.75|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.17|-0.75|0.002
91639725|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-0.39||||0.008|TWO_SIDED|95.0|-0.68|-0.1|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.1|-0.68|0.008
91639726|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-2.35||||0.069|TWO_SIDED|95.0|-4.89|0.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||0.19|-4.89|0.069
91639727|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-3.39||||0.01|TWO_SIDED|95.0|-5.95|-0.84|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||-0.84|-5.95|0.01
91673288|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.39|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-0.99|<.0001
91485587|NCT03438383|182844269|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.0035||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.0035
91639728|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|0.84||||0.549|TWO_SIDED|95.0|-1.93|3.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.61|-1.93|0.549
91639729|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|0.49||||0.728|TWO_SIDED|95.0|-2.28|3.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.26|-2.28|0.728
91639730|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.38|||<|0.001|TWO_SIDED|95.0|-2.14|-0.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.61|-2.14|<0.001
91639731|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.12||||0.004|TWO_SIDED|95.0|-1.89|-0.36|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.36|-1.89|0.004
91639732|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.18|||<|0.001|TWO_SIDED|95.0|-1.82|-0.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.53|-1.82|<0.001
91639733|NCT01694849|183171005|SUPERIORITY||Difference in least square mean change|-1.08||||0.001|TWO_SIDED|95.0|-1.72|-0.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.43|-1.72|0.001
91716238|NCT00922636|183323657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.938||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.938
91716239|NCT00922636|183323657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.002||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.002
91716240|NCT00729521|183323714|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.92|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.95|||Mixed Models Analysis|Mixed Effects Poisson Regression|Comparison group is the control arm.|||0.95|0.88|<0.05
91716241|NCT00729521|183323714|SUPERIORITY_OR_OTHER||Incident Rate Ratio|0.91|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.94|||Mixed Models Analysis|Mixed Effected Poisson Model Regression|Comparison group is the control arm.|||0.94|0.88|<.05
91716242|NCT01774981|183323739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0449|||||||t-test, 1 sided|||||||0.0449
91716243|NCT01774981|183323739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0808|||||||t-test, 1 sided|||||||0.0808
91716244|NCT01774981|183323739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2219|||||||t-test, 1 sided|||||||0.2219
91716245|NCT02915835|183323749|SUPERIORITY|||||||0.7|||||||ANCOVA|||||||0.70
91485588|NCT03438383|182844269|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||1.5e-05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.000015
91716246|NCT02915835|183323750|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
91716247|NCT02915835|183323751|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716248|NCT02915835|183323752|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716249|NCT02915835|183323753|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716250|NCT02915835|183323754|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716251|NCT02915835|183323755|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716252|NCT02915835|183323756|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91639734|NCT01694849|183171006|SUPERIORITY||Difference in least square mean change|-2.8||||0.066|TWO_SIDED|95.0|-5.79|0.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Least square mean changes from baseline|||0.18|-5.79|0.066
91716253|NCT02915835|183323757|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716254|NCT02915835|183323758|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716255|NCT02915835|183323759|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716256|NCT02915835|183323760|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716257|NCT02915835|183323761|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716258|NCT02915835|183323762|SUPERIORITY|||||||0.56|||||||Log Rank|||||||.56
91716259|NCT02915835|183323763|SUPERIORITY|||||||0.35|||||||Log Rank|||||||.35
91716260|NCT02915835|183323765|SUPERIORITY|||||||0.76|||||||ANCOVA|||||||.76
91716261|NCT02915835|183323766|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||.57
91716262|NCT02915835|183323767|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||.40
91716263|NCT02915835|183323768|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||.49
91716264|NCT02915835|183323769|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||.75
91716265|NCT02915835|183323770|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||.41
91716266|NCT02915835|183323771|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
91716267|NCT02915835|183323772|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
91716268|NCT02915835|183323773|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.11
91716269|NCT02915835|183323774|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
91716270|NCT02915835|183323775|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
91716271|NCT02915835|183323776|SUPERIORITY|||||||0.54|||||||ANCOVA|||||||0.54
91716272|NCT02915835|183323777|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||.90
91716273|NCT02915835|183323778|SUPERIORITY|||||||0.68|||||||ANCOVA|||||||.68
91716274|NCT02915835|183323779|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||.25
91716275|NCT02915835|183323780|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||.95
91716276|NCT02915835|183323781|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
91716277|NCT02915835|183323782|SUPERIORITY|||||||0.82|||||||ANCOVA|||||||.82
91716278|NCT02915835|183323783|SUPERIORITY|||||||0.47|||||||ANCOVA|||||||.47
91716279|NCT02915835|183323784|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
91716280|NCT02915835|183323785|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
91716281|NCT02915835|183323786|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
91716282|NCT02915835|183323788|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
91716283|NCT02915835|183323789|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
91716284|NCT02915835|183323790|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
91716285|NCT02915835|183323791|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
91716286|NCT02915835|183323792|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
91716287|NCT02915835|183323793|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
91716288|NCT02915835|183323794|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
91716289|NCT02915835|183323795|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
91716290|NCT02915835|183323796|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
91716291|NCT02915835|183323797|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||0.95
91716292|NCT02915835|183323798|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
91716293|NCT02915835|183323799|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
91716294|NCT02915835|183323800|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
91716295|NCT02915835|183323801|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
91716296|NCT02915835|183323802|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91716297|NCT02915835|183323803|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
91716298|NCT02915835|183323804|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
91716299|NCT02915835|183323805|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
91716300|NCT02915835|183323806|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
91526475|NCT01807650|182928101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|15.1|=|0.0145|TWO_SIDED|95.0|0.7|6.4||Day 28|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||6.4|0.7|=0.0145
91716301|NCT02915835|183323807|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
91716302|NCT02915835|183323808|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
91716303|NCT02456727|183323809|SUPERIORITY||Mean Difference (Net)|-0.3714|STANDARD_ERROR_OF_MEAN|0.2039||0.0691|TWO_SIDED|95.0|-0.772|0.0291|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0291|-0.7720|0.0691
91716304|NCT02456727|183323810|SUPERIORITY||Mean Difference (Net)|-0.1631|STANDARD_ERROR_OF_MEAN|0.246||0.5077|TWO_SIDED|95.0|-0.6452|0.319|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.319|-0.6452|0.5077
91716305|NCT02456727|183323811|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0724|STANDARD_ERROR_OF_MEAN|0.0399||0.24|TWO_SIDED|95.0|-0.0058|0.1506|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1506|-0.0058|0.24
91716306|NCT02456727|183323812|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0531|STANDARD_ERROR_OF_MEAN|0.0487||0.17|TWO_SIDED|95.0|-0.0422|0.1485|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1485|-0.0422|0.17
91716307|NCT02456727|183323813|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0625|STANDARD_ERROR_OF_MEAN|0.0396||0.17|TWO_SIDED|95.0|-0.0151|0.1401|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1401|-0.0151|0.17
91716308|NCT02456727|183323814|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0882|STANDARD_ERROR_OF_MEAN|0.0488||0.4|TWO_SIDED|95.0|-0.0075|0.184|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.184|-0.0075|0.40
91639735|NCT01694849|183171006|SUPERIORITY||Difference in least square mean change|0.77||||0.615|TWO_SIDED|95.0|-2.24|3.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.77|-2.24|0.615
91716309|NCT02456727|183323815|SUPERIORITY||Mean Difference (Net)|-0.2643|STANDARD_ERROR_OF_MEAN|0.1782||0.1387|TWO_SIDED|95.0|-0.6136|0.0851|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.0851|-0.6136|0.1387
91716310|NCT02456727|183323816|SUPERIORITY||Mean Difference (Net)|-0.2334|STANDARD_ERROR_OF_MEAN|0.2124||0.2725|TWO_SIDED|95.0|-0.6497|0.1829|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.1829|-0.6497|0.2725
91716311|NCT02456727|183323817|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0426|STANDARD_ERROR_OF_MEAN|0.0388||0.07|TWO_SIDED|95.0|-0.0334|0.1185|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1185|-0.0334|0.07
91716312|NCT02456727|183323818|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0283|STANDARD_ERROR_OF_MEAN|0.0477||0.07|TWO_SIDED|95.0|-0.0651|0.1218|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1218|-0.0651|0.07
91716313|NCT02456727|183323819|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0262|STANDARD_ERROR_OF_MEAN|0.0356||0.02|TWO_SIDED|95.0|-0.0436|0.0961|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.0961|-0.0436|0.02
91673289|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.87|0.0002
91673290|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.29|<.0001
91673291|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.28|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.28|<.0001
91673292|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.11|<.0001
91527855|NCT06173570|182930693|SUPERIORITY||Mean Difference (Net)|-9.87||||0.086|TWO_SIDED|95.0|-21.14|1.41|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||1.41|-21.14|0.086
91673293|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.35|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.35|<.0001
91673294|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.11|<.0001
91673295|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.23|<.0001
91673296|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.19||0.0005|TWO_SIDED|95.0|-1.03|-0.29|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.03|0.0005
91673297|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.13|<.0001
91673298|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.2||0.0246|TWO_SIDED|95.0|-0.82|-0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.82|0.0246
91673299|NCT02709486|183241166|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.2||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.10|0.0003
91716314|NCT02456727|183323820|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0323|STANDARD_ERROR_OF_MEAN|0.044||0.06|TWO_SIDED|95.0|-0.0539|0.1186|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1186|-0.0539|0.06
91716315|NCT02456727|183323821|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.1475|TWO_SIDED|95.0|-0.5288|0.0795|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0795|-0.5288|0.1475
91716316|NCT02456727|183323822|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3038|TWO_SIDED|95.0|-0.546|0.1706|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.1706|-0.546|0.3038
91716317|NCT02456727|183323823|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0251|STANDARD_ERROR_OF_MEAN|0.0392||0.03|TWO_SIDED|95.0|-0.0517|0.1018|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.1018|-0.0517|0.03
91716318|NCT02456727|183323824|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0018|STANDARD_ERROR_OF_MEAN|0.0481||0.02|TWO_SIDED|95.0|-0.0925|0.096|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.096|-0.0925|0.02
91716319|NCT02456727|183323825|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|-0.0104|STANDARD_ERROR_OF_MEAN|0.036||0|TWO_SIDED|95.0|-0.081|0.0602|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.0602|-0.081|0.00
91716320|NCT02456727|183323826|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0154|STANDARD_ERROR_OF_MEAN|0.0464||0.03|TWO_SIDED|95.0|-0.0755|0.1063|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.1063|-0.0755|0.03
91716321|NCT02456727|183323827|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.5336||0.8778|TWO_SIDED|95.0|-0.9659|1.13|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.13|-0.9659|0.8778
91793000|NCT02038829|183463489|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0526|STANDARD_ERROR_OF_MEAN|0.0184||0.0046|TWO_SIDED|95.0|0.0163|0.0888|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0888|0.0163|0.0046
91673300|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.57||0.6427|TWO_SIDED|95.0|-3.9|6.29|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.29|-3.90|0.6427
91716322|NCT02456727|183323828|SUPERIORITY||Mean Difference (Net)|0.3623|STANDARD_ERROR_OF_MEAN|0.6252||0.5626|TWO_SIDED|95.0|-0.8667|1.5912|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.5912|-0.8667|0.5626
91793001|NCT02038829|183463489|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0842|STANDARD_ERROR_OF_MEAN|0.0185|<|0.0001|TWO_SIDED|95.0|0.0478|0.1206|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1206|0.0478|<0.0001
91673301|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|2.59||0.4208|TWO_SIDED|95.0|-7.22|3.04|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.04|-7.22|0.4208
91673302|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.73||0.8204|TWO_SIDED|95.0|-6.03|4.79|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.79|-6.03|0.8204
91673303|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-4.52|STANDARD_ERROR_OF_MEAN|2.85||0.1157|TWO_SIDED|95.0|-10.16|1.13|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.13|-10.16|0.1157
91527500|NCT04534114|182930302|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.94||||0.944|TWO_SIDED|95.0|0.19|4.68|||Log Rank|||||4.68|0.19|0.944
91639736|NCT01694849|183171007|SUPERIORITY||Difference in least square mean change|-17.4||||0.307|TWO_SIDED|95.0|-50.88|16.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||16.08|-50.88|0.307
91639737|NCT01694849|183171007|SUPERIORITY||Difference in least square mean change|-21.41||||0.213|TWO_SIDED|95.0|-55.17|12.34|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.34|-55.17|0.213
91639738|NCT01694849|183171008|SUPERIORITY||Difference in least square mean change|-0.23||||0.003|TWO_SIDED|95.0|-0.37|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.37|0.003
91639739|NCT01694849|183171008|SUPERIORITY||Difference in least square mean change|-0.14||||0.068|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.29|0.068
91639740|NCT01694849|183171009|SUPERIORITY||Difference in least square mean change|-0.8||||0.448|TWO_SIDED|95.0|-2.86|1.27|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.27|-2.86|0.448
91639741|NCT01694849|183171009|SUPERIORITY||Difference in least square mean change|-1.17||||0.267|TWO_SIDED|95.0|-3.25|0.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.9|-3.25|0.267
91639742|NCT01694849|183171010|SUPERIORITY||Difference in least square mean change|-0.05||||0.095|TWO_SIDED|95.0|-0.11|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.11|0.095
91639743|NCT01694849|183171010|SUPERIORITY||Difference in least square mean change|-0.07||||0.022|TWO_SIDED|95.0|-0.13|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.13|0.022
91639744|NCT01694849|183171011|SUPERIORITY||Difference in least square mean change|-0.46||||0.077|TWO_SIDED|95.0|-0.96|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.96|0.077
91639745|NCT01694849|183171011|SUPERIORITY||Difference in least square mean change|-0.36||||0.172|TWO_SIDED|95.0|-0.87|0.16|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.16|-0.87|0.172
91639746|NCT01694849|183171012|SUPERIORITY||Difference in least square mean change|-0.04||||0.732|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.17|-0.24|0.732
91639747|NCT01694849|183171012|SUPERIORITY||Difference in least square mean change|-0.2||||0.062|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.4|0.062
91639748|NCT01694849|183171013|SUPERIORITY||Difference in least square mean change|3.66||||0.4|TWO_SIDED|95.0|-4.89|12.2|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.2|-4.89|0.4
91639749|NCT01694849|183171013|SUPERIORITY||Difference in least square mean change|-16.22|||<|0.001|TWO_SIDED|95.0|-24.99|-7.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-7.44|-24.99|<0.001
91639750|NCT01694849|183171014|SUPERIORITY||Difference in least square mean change|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Fibrinogen||-0.17|-0.54|<0.001
91639751|NCT01694849|183171014|SUPERIORITY||Difference in least square mean change|-0.27||||0.005|TWO_SIDED|95.0|-0.46|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors||Fibrinogen|Standard error of the least square mean|-0.08|-0.46|0.005
91639752|NCT01694849|183171014|SUPERIORITY||Difference in least square mean change|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.15|-0.35|<0.001
91639753|NCT01694849|183171014|SUPERIORITY||Difference in least square mean change|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.17|-0.37|<0.001
91639754|NCT01694849|183171015|SUPERIORITY||Difference in least square mean change|0.57||||0.742|TWO_SIDED|95.0|-2.9|4.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||4.06|-2.9|0.742
91639755|NCT01694849|183171015|SUPERIORITY||Difference in least square mean change|2.9||||0.107|TWO_SIDED|95.0|-0.63|6.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||6.43|-0.63|0.107
91639756|NCT01694849|183171015|SUPERIORITY||Difference in least square mean change|0.5||||0.362|TWO_SIDED|95.0|-0.58|1.59|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.59|-0.58|0.362
91639757|NCT01694849|183171015|SUPERIORITY||Difference in least square mean change|0.07||||0.894|TWO_SIDED|95.0|-1.03|1.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.18|-1.03|0.894
91639758|NCT01694849|183171016|SUPERIORITY||Difference in least square mean change|-0.76||||0.229|TWO_SIDED|95.0|-2.0|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.48|-2|0.229
91639759|NCT01694849|183171016|SUPERIORITY||Difference in least square mean change|-0.45||||0.463|TWO_SIDED|95.0|-1.67|0.76|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.76|-1.67|0.463
91639760|NCT01694849|183171017|SUPERIORITY||Difference in least square mean change|-0.21||||0.065|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.42|0.065
91639761|NCT01694849|183171017|SUPERIORITY||Difference in least square mean change|-0.19||||0.098|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.41|0.098
91639762|NCT01694849|183171018|SUPERIORITY||Difference in least square mean change|0.7||||0.553|TWO_SIDED|95.0|-1.61|3.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.01|-1.61|0.553
91639763|NCT01694849|183171018|SUPERIORITY||Difference in least square mean change|4.31|||<|0.001|TWO_SIDED|95.0|1.97|6.64|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.64|1.97|<0.001
91639764|NCT01694849|183171019|SUPERIORITY||Difference in least square mean change|0.04||||0.861|TWO_SIDED|95.0|-0.37|0.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.44|-0.37|0.861
91639765|NCT01694849|183171019|SUPERIORITY||Difference in least square mean change|-0.4||||0.052|TWO_SIDED|95.0|-0.81|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|-0.81|0.052
91639766|NCT01694849|183171020|SUPERIORITY||Difference in least square mean change|0.01||||0.473|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.02|-0.01|0.473
91639767|NCT01694849|183171020|SUPERIORITY||Difference in least square mean change|0.01||||0.124|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|0|0.124
91639768|NCT01694849|183171021|SUPERIORITY||Difference in least square mean change|0.81|||<|0.001|TWO_SIDED|95.0|0.47|1.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.15|0.47|<0.001
91639769|NCT01694849|183171021|SUPERIORITY||Difference in least square mean change|0.85|||<|0.001|TWO_SIDED|95.0|0.5|1.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.19|0.5|<0.001
91639770|NCT01694849|183171022|SUPERIORITY||Difference in least square mean change|0.0||||0.842|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.04|0.842
91639771|NCT01694849|183171022|SUPERIORITY||Difference in least square mean change|0.01||||0.589|TWO_SIDED|95.0|-0.03|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.03|0.589
91639772|NCT01694849|183171023|SUPERIORITY||Difference in least square mean change|48.93||||0.325|TWO_SIDED|95.0|-8.73|146.6|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||146.6|-8.73|0.325
91639773|NCT01694849|183171023|SUPERIORITY||Difference in least square mean change|93.21||||0.066|TWO_SIDED|95.0|-6.06|192.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||192.49|-6.06|0.066
91639774|NCT01694849|183171024|SUPERIORITY||Difference in least square mean change|2.41|||<|0.001|TWO_SIDED|95.0|1.1|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|1.1|<0.001
91639775|NCT01694849|183171024|SUPERIORITY||Difference in least square mean change|1.59||||0.019|TWO_SIDED|95.0|0.26|2.91|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.91|0.26|0.019
91639776|NCT01694849|183171025|SUPERIORITY||Difference in least square mean change|0.0||||0.447|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.447
91639777|NCT01694849|183171025|SUPERIORITY||Difference in least square mean change|0.0||||0.758|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.758
91639778|NCT01694849|183171026|SUPERIORITY||Difference in least square mean change|-0.04||||0.942|TWO_SIDED|95.0|-1.12|1.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.04|-1.12|0.942
91639779|NCT01694849|183171026|SUPERIORITY||Difference in least square mean change|0.57||||0.304|TWO_SIDED|95.0|-0.52|1.66|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.66|-0.52|0.304
91639780|NCT05146999|183171042|SUPERIORITY||Treatment difference|83.8|||<|0.001|TWO_SIDED|95.0|72.81|94.87|||Cochran-Mantel-Haenszel|||||94.87|72.81|<0.001
91639781|NCT03301272|183171082|OTHER||Difference in differences|0.0||||0.5|TWO_SIDED|||||The threshold for statistical significance is 0.05|Regression, Linear|||||||0.5
91639782|NCT03457701|183171087|SUPERIORITY||Adjusted mean difference.|0.02||||0.9971|TWO_SIDED|95.0|-10.13|10.16|||Mixed Models Analysis||Analysis was based on a mixed effects model fitted with fixed effect terms for treatment, period, and iron isotope type and a random participant effect.|The null hypotheses is defined as the difference in fractional iron absorption between treatment arms (Daprodustat - rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) is equal to zero.||10.16|-10.13|0.9971
91639783|NCT01598831|183171147|SUPERIORITY||Risk Difference (RD)|-2.55||||0.318|TWO_SIDED|95.0|-3.68|8.77||The threshold for statistical significance was a two sided 5%|Cochran-Mantel-Haenszel|CMH test controlled for the stratification factor.|Rates by Arm are 26.8% for ART-123 and 29.4% for Placebo||In a post hoc sensitivity analysis for the primary outcome that accounted for pooled site as a random effect, the adjusted 28-day all-cause mortality rate was 24.8%in the rhsTM group vs 27.5%in the placebo group (P = .31).|8.77|-3.68|0.318
91716323|NCT02456727|183323829|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0362|STANDARD_ERROR_OF_MEAN|0.0399||0.05|TWO_SIDED|95.0|-0.0419|0.1144|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.1144|-0.0419|0.05
91716324|NCT02456727|183323830|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0647|STANDARD_ERROR_OF_MEAN|0.0466||0.22|TWO_SIDED|95.0|-0.0266|0.156|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.156|-0.0266|0.22
91716325|NCT02456727|183323831|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0523|STANDARD_ERROR_OF_MEAN|0.0415||0.12|TWO_SIDED|95.0|-0.029|0.1335|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1335|-0.029|0.12
91639784|NCT04095039|183171154|SUPERIORITY|||||||0.077||||||p-value is based on a sample that is less than 10% of the planned sample size (planned n=4,000)|Finkelstein-Schoenfeld method|||Primary outcome is for the individually randomized cohort since DSMB had concerns about selection bias for the cluster-randomized population due to differences in baseline characteristics that leaned towards the arm objectives.||||0.077
91639785|NCT00736840|183171232|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Provided above|Sensitivity|0.74|STANDARD_ERROR_OF_MEAN|0.0363||0.0924|TWO_SIDED|95.0|0.6607|0.8809|||Exact binomial test|||The null hypothesis was sensitivity lower than 0.8. We assumed a sensitivity of 0.89 and required a power of 90% to test the hypothesis at a 5% level of significance, and calculated that 173 cirrhotic and 241 non-cirrhotic subjects were needed (for a one-sample binomial test of outcome versus constant).||0.8809|0.6607|0.0924
91639786|NCT00736840|183171233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size was calculated to enable the testing of both study hypotheses (together) with at least 80% power. Our best estimate of sensitivity of the HIS diagnosis in the population, was 0.9 and its specificity 0.79. Requiring a power of 90% for each of the hypotheses and a 5% level of significance, to test the null hypotheses 173 cirrhotic and 241 non-cirrhotic subjects were needed.Therefore a total of at least 414 subjects were required.|AUC ROC|0.785|STANDARD_ERROR_OF_MEAN|0.0485|<|0.0001|TWO_SIDED|95.0|0.737|0.834|||Regression, Logistic|||||0.834|0.737|<0.0001
91639787|NCT01728194|183171236|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||< 0.025
91639788|NCT01728194|183171237|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
91639789|NCT02309372|183171238|SUPERIORITY||Mean Difference (Net)|-0.76||||0.32|TWO_SIDED|95.0|-2.28|0.77|||t-test, 2 sided|||||0.77|-2.28|0.32
91639790|NCT03289676|183171270|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
91639791|NCT03289676|183171272|OTHER||Odds Ratio, log|1.12||||0.029|TWO_SIDED|95.0|1.0|1.24|||Regression, Logistic|||||1.24|1.00|0.029
91639792|NCT01314261|183171276|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.336
91639793|NCT01314261|183171276|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.171
91639794|NCT01314261|183171276|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.030
91639795|NCT01314261|183171277|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.102
91639796|NCT01314261|183171277|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.362
91639797|NCT01314261|183171277|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.079
91673304|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|2.41||0.5845|TWO_SIDED|95.0|-6.12|3.47|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.47|-6.12|0.5845
91639798|NCT01314261|183171281|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.083
91639799|NCT01314261|183171281|SUPERIORITY_OR_OTHER|||||||0.515|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.515
91673305|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.54||0.2514|TWO_SIDED|95.0|-7.97|2.11|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.11|-7.97|0.2514
91673306|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-6.68|STANDARD_ERROR_OF_MEAN|3.67||0.0717|TWO_SIDED|95.0|-13.97|0.6|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-13.97|0.0717
91673307|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-12.69|STANDARD_ERROR_OF_MEAN|3.74||0.001|TWO_SIDED|95.0|-20.11|-5.26|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-5.26|-20.11|0.0010
91673308|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|3.8||0.0079|TWO_SIDED|95.0|-17.85|-2.77|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.77|-17.85|0.0079
91639800|NCT01314261|183171281|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.221
91673309|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-10.56|STANDARD_ERROR_OF_MEAN|4.0||0.0096|TWO_SIDED|95.0|-18.49|-2.63|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.63|-18.49|0.0096
91673310|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-4.28|STANDARD_ERROR_OF_MEAN|4.37||0.3302|TWO_SIDED|95.0|-12.97|4.41|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.41|-12.97|0.3302
91673311|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-2.74|STANDARD_ERROR_OF_MEAN|4.54||0.5483|TWO_SIDED|95.0|-11.78|6.3|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.30|-11.78|0.5483
91673312|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|3.79||0.0774|TWO_SIDED|95.0|-14.26|0.76|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.76|-14.26|0.0774
91639801|NCT01314261|183171282|SUPERIORITY_OR_OTHER|||||||0.155|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.155
91639802|NCT01314261|183171282|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.214
91673313|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-12.48|STANDARD_ERROR_OF_MEAN|3.87||0.0017|TWO_SIDED|95.0|-20.15|-4.81|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-4.81|-20.15|0.0017
91673314|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-9.41|STANDARD_ERROR_OF_MEAN|3.74||0.0135|TWO_SIDED|95.0|-16.83|-1.99|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-1.99|-16.83|0.0135
91639803|NCT01314261|183171282|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.231
91639804|NCT01314261|183171283|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.127
91673315|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-10.04|STANDARD_ERROR_OF_MEAN|3.97||0.0129|TWO_SIDED|95.0|-17.91|-2.17|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.17|-17.91|0.0129
91673316|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.43||0.3869|TWO_SIDED|95.0|-12.66|4.96|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.96|-12.66|0.3869
91716326|NCT02456727|183323832|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0928|STANDARD_ERROR_OF_MEAN|0.0498||0.44|TWO_SIDED|95.0|-0.0047|0.1903|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1903|-0.0047|0.44
91716327|NCT02456727|183323833|SUPERIORITY||Mean Difference (Net)|0.4831|STANDARD_ERROR_OF_MEAN|0.5753||0.4014|TWO_SIDED|95.0|-0.6468|1.6129|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.6129|-0.6468|0.4014
91716328|NCT02456727|183323834|SUPERIORITY||Mean Difference (Net)|0.6617|STANDARD_ERROR_OF_MEAN|0.647||0.307|TWO_SIDED|95.0|-0.61|1.9334|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.9334|-0.61|0.307
91716329|NCT02456727|183323835|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0159|STANDARD_ERROR_OF_MEAN|0.0364||0.01|TWO_SIDED|95.0|-0.0555|0.0873|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.0873|-0.0555|0.01
91716330|NCT02456727|183323836|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0287|STANDARD_ERROR_OF_MEAN|0.0424||0.05|TWO_SIDED|95.0|-0.0544|0.1117|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.1117|-0.0544|0.05
91716331|NCT02456727|183323837|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0389|STANDARD_ERROR_OF_MEAN|0.0369||0.05|TWO_SIDED|95.0|-0.0335|0.1112|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1112|-0.0335|0.05
91673317|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|4.62||0.6485|TWO_SIDED|95.0|-11.31|7.08|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||7.08|-11.31|0.6485
91673318|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|1.61||0.0001|TWO_SIDED|95.0|-9.34|-3.03|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.03|-9.34|0.0001
91639805|NCT01314261|183171283|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.328
91639806|NCT01314261|183171283|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.166
91639807|NCT01314261|183171284|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.007
91716332|NCT02456727|183323838|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0608|STANDARD_ERROR_OF_MEAN|0.0436||0.18|TWO_SIDED|95.0|-0.0247|0.1463|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1463|-0.0247|0.18
91716333|NCT02456727|183323839|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1658|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1658
91793002|NCT02038829|183463489|NON_INFERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1255|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.089|0.1621|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1621|0.0890|<0.0001
91639808|NCT01314261|183171284|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.029
91639809|NCT01314261|183171284|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.105
91673319|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-9.13|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-12.26|-6.0|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-6.00|-12.26|<.0001
91673320|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.79||0.0008|TWO_SIDED|95.0|-9.51|-2.5|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.50|-9.51|0.0008
91673321|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-6.97|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|-10.44|-3.51|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.51|-10.44|<.0001
91673322|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-3.08|STANDARD_ERROR_OF_MEAN|1.87||0.1004|TWO_SIDED|95.0|-6.76|0.6|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-6.76|0.1004
91716334|NCT02456727|183323840|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1172|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1172
91673323|NCT02709486|183241169|SUPERIORITY||Least Square Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.86||0.0079|TWO_SIDED|95.0|-8.59|-1.3|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect||-1.30|-8.59|0.0079
91673324|NCT02709486|183241184|SUPERIORITY||Odds Ratio (OR)|0.1||||0.0027|TWO_SIDED|95.0|0.02|0.46|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.46|0.02|0.0027
91673325|NCT02709486|183241184|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0033|TWO_SIDED|95.0|0.05|0.54|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.54|0.05|0.0033
91673326|NCT02709486|183241185|SUPERIORITY|||||||0.0002||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0002
91673327|NCT02709486|183241185|SUPERIORITY|||||||0.0007||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0007
91673328|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.59|0.29|<.0001
91716335|NCT02456727|183323841|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0326|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0326
91716336|NCT02456727|183323842|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0026|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0026
91639810|NCT01314261|183171287|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.028
91716337|NCT02456727|183323843|SUPERIORITY|||||||0.129||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.129
91639811|NCT01314261|183171287|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.051
91639812|NCT01314261|183171287|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.021
91639813|NCT01231620|183171288|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.73||||0.25|TWO_SIDED|95.0|-1.79|0.75|||Wilcoxon rank sum||IV Zanamivir 300 mg versus IV Zanamivir 600 mg|||0.75|-1.79|0.25
91639814|NCT01231620|183171288|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.48||||0.39|TWO_SIDED|95.0|-2.11|0.97|||Wilcoxon rank sum||Oral oseltamivir 75 mg versus IV Zanamivir 600 mg|||0.97|-2.11|0.39
91639815|NCT01231620|183171289|SUPERIORITY_OR_OTHER|||||||0.506|||||||Wei-Johnson method|||||||0.506
91639816|NCT01231620|183171289|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wei-Johnson method|||||||0.41
91639817|NCT04557189|183171337|SUPERIORITY||Adjusted Treatment Difference|0.241|||||TWO_SIDED|95.0|0.031|0.452|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.452|0.031|
91639818|NCT04557189|183171338|SUPERIORITY||Adjusted Treatment Difference|0.175|||||TWO_SIDED|95.0|-0.044|0.394|||||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on Cochran-Mantel-Haenszel (CMH) method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|0.394|-0.044|
91639819|NCT04557189|183171339|SUPERIORITY||Adjusted Treatment Difference|-0.094|||||TWO_SIDED|95.0|-0.253|0.059|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.059|-0.253|
91639820|NCT04557189|183171340|SUPERIORITY||Adjusted Treatment Difference|-0.141|||||TWO_SIDED|95.0|-0.316|0.033|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.033|-0.316|
91639821|NCT04557189|183171341|SUPERIORITY||Adjusted Treatment Difference|0.191|||||TWO_SIDED|95.0|-0.029|0.41|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.410|-0.029|
91639822|NCT04557189|183171342|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
91639823|NCT04557189|183171343|SUPERIORITY||Adjusted Treatment Difference|-0.234|||||TWO_SIDED|95.0|-0.448|-0.019|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||-0.019|-0.448|
91639824|NCT04557189|183171344|SUPERIORITY||Hazard Ratio (HR)|0.393|||||TWO_SIDED|95.0|0.122|1.259|||||The hazard ratio is derived from a Cox proportional hazard model with treatment group and the number of Apfel risk factors (3 or 4) as independent variables.|||1.259|0.122|
91639825|NCT04557189|183171345|SUPERIORITY||Difference in LSM Estimates|0.188|||||TWO_SIDED|95.0|-0.402|0.777||||||30 Minutes Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.777|-0.402|
91639826|NCT04557189|183171345|SUPERIORITY||Difference in LSM Estimates|0.401|||||TWO_SIDED|95.0|-0.258|1.059||||||1 Hour Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|1.059|-0.258|
91639827|NCT04557189|183171345|SUPERIORITY||Difference in LSM Estimates|0.265|||||TWO_SIDED|95.0|0.0|0.786||||||2 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.786|0|
91639828|NCT04557189|183171345|SUPERIORITY||Difference in LSM Estimates|0.097|||||TWO_SIDED|95.0|-0.093|0.286||||||6 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.286|-0.093|
91639829|NCT04557189|183171345|SUPERIORITY||Difference in LSM Estimates|-0.203|||||TWO_SIDED|95.0|-0.575|0.17||||||24 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.170|-0.575|
91716338|NCT02456727|183323844|SUPERIORITY|||||||0.031||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.031
91673329|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.78|0.38|0.0010
91673330|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.70|0.36|<.0001
91673331|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0067|TWO_SIDED|95.0|0.44|0.88|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.88|0.44|0.0067
91673332|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0087|TWO_SIDED|95.0|0.45|0.89|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.89|0.45|0.0087
91673333|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.74||||0.0787|TWO_SIDED|95.0|0.53|1.04|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.53|0.0787
91673334|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0129|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0129
91673335|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0124|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0124
91673336|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0399|TWO_SIDED|95.0|0.5|0.98|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.98|0.50|0.0399
91673337|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.62||||0.006|TWO_SIDED|95.0|0.45|0.87|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.87|0.45|0.0060
91673338|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9449|TWO_SIDED|95.0|0.72|1.42|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.42|0.72|0.9449
91673339|NCT02709486|183241186|SUPERIORITY||Odds Ratio (OR)|0.84||||0.3238|TWO_SIDED|95.0|0.6|1.18|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.18|0.60|0.3238
91673340|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|0.54|0.82|||Negative binomial model|||Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.54|0.0001
91673341|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.08||0.0067|TWO_SIDED|95.0|0.61|0.92|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.61|0.0067
91673342|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.64|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|95.0|0.51|0.82|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.51|0.0003
91673343|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.09||0.0112|TWO_SIDED|95.0|0.58|0.93|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.93|0.58|0.0112
91673344|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.09||0.0093|TWO_SIDED|95.0|0.56|0.92|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.56|0.0093
91673345|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.09||0.0237|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.96|0.59|0.0237
91673346|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.0374|TWO_SIDED|95.0|0.56|0.98|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.98|0.56|0.0374
91716339|NCT02456727|183323845|SUPERIORITY|Difference in change in proportion pre and post-treatment differs by treatment arm.||||||0.0059|||||||Mixed Models Analysis|||||||0.0059
91716340|NCT02456727|183323846|SUPERIORITY|||||||0.0385|||||||Mixed Models Analysis|||||||0.0385
91673347|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.11||0.0468|TWO_SIDED|95.0|0.57|1.0|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.57|0.0468
91673348|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11||0.0751|TWO_SIDED|95.0|0.59|1.03|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.03|0.59|0.0751
91673349|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.11||0.1305|TWO_SIDED|95.0|0.61|1.06|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.06|0.61|0.1305
91673350|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.13||0.3057|TWO_SIDED|95.0|0.63|1.16|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.63|0.3057
91673351|NCT02709486|183241188|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.13||0.2056|TWO_SIDED|95.0|0.61|1.11|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.11|0.61|0.2056
91673352|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.0441|TWO_SIDED|95.0|0.39|0.99|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.99|0.39|0.0441
91673353|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.17||0.1895|TWO_SIDED|95.0|0.46|1.17|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.17|0.46|0.1895
91673354|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0567|TWO_SIDED|95.0|0.35|1.01|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.01|0.35|0.0567
91673355|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.2||0.296|TWO_SIDED|95.0|0.44|1.28|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.44|0.2960
91673356|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.65|STANDARD_ERROR_OF_MEAN|0.18||0.1215|TWO_SIDED|95.0|0.37|1.12|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.12|0.37|0.1215
91673357|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.22||0.3569|TWO_SIDED|95.0|0.44|1.34|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.34|0.44|0.3569
91673358|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.21||0.2096|TWO_SIDED|95.0|0.36|1.25|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.25|0.36|0.2096
91673359|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.22||0.2387|TWO_SIDED|95.0|0.37|1.28|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.37|0.2387
91673360|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.71|STANDARD_ERROR_OF_MEAN|0.22||0.2627|TWO_SIDED|95.0|0.39|1.29|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.29|0.39|0.2627
91673361|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.22||0.2863|TWO_SIDED|95.0|0.4|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group||1.31|0.40|0.2863
91716341|NCT00113607|183323853|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.79||||0.019|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||||0.96|0.65|0.0190
91673362|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.27||0.556|TWO_SIDED|95.0|0.43|1.58|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.58|0.43|0.5560
91673363|NCT02709486|183241190|SUPERIORITY||LS Mean Ratio|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.5076|TWO_SIDED|95.0|0.42|1.53|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.53|0.42|0.5076
91716342|NCT00113607|183323854|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.86||||0.0835|TWO_SIDED|95.0|0.72|1.02|||Log Rank|||||1.02|0.72|0.0835
91716343|NCT00113607|183323855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.646||||0.008|TWO_SIDED|95.0|1.144|2.367|||Fisher Exact|||||2.367|1.144|0.0080
91716344|NCT00113607|183323856|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8203|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||||1.46|0.62|0.8203
91716345|NCT02974868|183323874|SUPERIORITY||Mean of Difference from Placebo|31.14|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|18.78|43.5||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.50|18.78|<.0001
91716346|NCT02974868|183323874|SUPERIORITY||Mean of Difference from Placebo|49.18|STANDARD_ERROR_OF_MEAN|6.35|<|0.0001|TWO_SIDED|95.0|36.62|61.74||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||61.74|36.62|<.0001
91716347|NCT02974868|183323875|OTHER||Mean of Difference from Placebo|25.78|STANDARD_ERROR_OF_MEAN|10.64||0.0094|TWO_SIDED|90.0|7.98|43.58|||Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.58|7.98|0.0094
91716348|NCT02974868|183323875|OTHER||Mean of Difference from Placebo|46.61|STANDARD_ERROR_OF_MEAN|10.51|<|0.0001|TWO_SIDED|90.0|29.02|64.2|||Mixed Model Repeated Measure|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||64.20|29.02|<.0001
91716349|NCT02974868|183323880|OTHER||Difference in Percentage from Placebo|47.9|||<|0.0001|TWO_SIDED|90.0|34.2|60.7|||Chan and Zhang method|||||60.7|34.2|<.0001
91716350|NCT02974868|183323880|OTHER||Difference in Percentage from Placebo|61.7|||<|0.0001|TWO_SIDED|90.0|48.2|73.6|||Chan and Zhang method|||||73.6|48.2|<.0001
91673364|NCT00536484|183241211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.4||Significance level p \<0.05|ANCOVA|Terms for treatment, center and baseline as covariate and baseline by treatment interaction.|The LS mean difference \& 95% CI were calculated at mean baseline = 12.9 (centered baseline used in model)|Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine \& placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm||-0.4|-1.1|0.0002
91673365|NCT00536484|183241212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0136||95.0|-0.8|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment, baseline covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||-0.1|-0.8|0.0136
91673366|NCT00536484|183241212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.3|-1.1|0.0002
91673367|NCT00536484|183241213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1057||95.0|-0.9|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.9|0.1057
91673368|NCT00536484|183241213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0338||95.0|-1.1|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.0|-1.1|0.0338
91716351|NCT01663402|183323909|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0003|TWO_SIDED|95.0|0.78|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).||0.93|0.78|0.0003
91716352|NCT01663402|183323910|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.||0.95|0.81|0.0013
91716353|NCT01663402|183323911|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.006|TWO_SIDED|95.0|0.8|0.96||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.96|0.80|0.0060
91716354|NCT01663402|183323912|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0003|TWO_SIDED|95.0|0.81|0.94||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.94|0.81|0.0003
91716355|NCT01663402|183323913|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0003|TWO_SIDED|95.0|0.79|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.93|0.79|0.0003
91716356|NCT01663402|183323914|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3824|TWO_SIDED|95.0|0.76|1.11||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||1.11|0.76|0.3824
91673369|NCT00536484|183241213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0003||95.0|-1.5|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.5|-1.5|0.0003
91673370|NCT00536484|183241214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1666||95.0|-0.6|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.6|0.1666
91673371|NCT00536484|183241214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0506||95.0|-0.8|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||0.0|-0.8|0.0506
91673372|NCT00536484|183241214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0014||95.0|-1.0|-0.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.2|-1.0|0.0014
91673373|NCT00536484|183241215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2054||95.0|-0.4|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||0.1|-0.4|0.2054
91673374|NCT00536484|183241215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0225||95.0|-0.6|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.0|-0.6|0.0225
91673375|NCT00536484|183241215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0167||95.0|-0.6|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-0.1|-0.6|0.0167
91673376|NCT00536484|183241216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8019||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8019
91673377|NCT00536484|183241216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3881||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.3881
91673378|NCT00536484|183241216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.324||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.1|-0.2|0.3240
91673379|NCT00536484|183241217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8279||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8279
91673380|NCT00536484|183241217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5059||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.5059
91673381|NCT00536484|183241217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0806||95.0|-0.4|0.0||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.0|-0.4|0.0806
91673382|NCT00536484|183241218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0203||95.0|-3.2|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.3|-3.2|0.0203
91673383|NCT00536484|183241218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.8||0.0007||95.0|-4.2|-1.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-1.1|-4.2|0.0007
91673384|NCT00536484|183241218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-4.9|-1.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-1.7|-4.9|<0.0001
91673385|NCT00536484|183241219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001||95.0|-10.7|-4.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-4.9|-10.7|<0.0001
91673386|NCT00536484|183241220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|5.3|11.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Concern domain"||11.5|5.3|<0.0001
91673387|NCT00536484|183241220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|3.9|10.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Coping domain"||10.2|3.9|<0.0001
91673388|NCT00536484|183241220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.6||0.0036||95.0|1.5|7.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate||"Week 12 minus Baseline~Sleep domain"||7.8|1.5|0.0036
91673389|NCT00536484|183241220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0007||95.0|1.6|5.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Social interaction domain"||5.8|1.6|0.0007
91673390|NCT00536484|183241220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001||95.0|3.6|8.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~HRQL scale score total"||8.9|3.6|<0.0001
91673391|NCT00536484|183241221|SUPERIORITY_OR_OTHER|||||||0.0087||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0087
91716357|NCT03387267|183323943|OTHER||AUC under ROC curve|0.64|||||ONE_SIDED|95.0||0.72||||||||0.72||
91793003|NCT02038829|183463489|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1963|STANDARD_ERROR_OF_MEAN|0.0184|<|0.0001|TWO_SIDED|95.0|0.1601|0.2325|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2325|0.1601|<0.0001
91485589|NCT02435069|182844275|SUPERIORITY|||||||0.069751||||||significance level set at \<0.05 a priori|two-sample pooled variance t-test|Two-tailed||"Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.~Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%)."||||0.069751
91673392|NCT00536484|183241221|SUPERIORITY_OR_OTHER|||||||0.0008||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0008
91673393|NCT00536484|183241221|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0006
91673394|NCT00536484|183241222|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0129
91673395|NCT00536484|183241222|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0100
91673396|NCT00536484|183241222|SUPERIORITY_OR_OTHER|||||||0.0009||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0009
91485590|NCT02435069|182844276|SUPERIORITY|||||||0.172|||||||two-sample pooled variance t-test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.172
91673397|NCT00536484|183241223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.4||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.4|-0.9|<0.0001
91673398|NCT00536484|183241223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.5|-1.1|<0.0001
91716358|NCT03387267|183323944|OTHER||AUC under ROC curve|0.65|||||TWO_SIDED|||||||||||||
91673399|NCT00536484|183241223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.3|-0.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.7|-1.3|<0.0001
91673400|NCT01770431|183241238|SUPERIORITY||chi-squared|14.7315||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
91673401|NCT01770431|183241239|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.81|||Regression, Cox|||||0.81|0.55|<0.0001
91673402|NCT02610816|183241267|SUPERIORITY|||||||0.04||||||P-values are not adjusted for multiplicity, since a single primary endpoint is analyzed|Mixed Models Analysis|No adjustment of degrees of freedom is needed.||The primary treatment comparison was to compare change in PEESS V2.0 scores of 1FED versus 4FED. The primary null hypothesis was 4FED would be no more effective than 1FED. This was designed as a superiority trial.||||0.04
91673403|NCT02610816|183241268|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05.|Mixed Models Analysis|||||||<0.0001
91485591|NCT02435069|182844279|SUPERIORITY|||||||0.8028|||||||two-sample pooled variance t-test|two-sided||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush in the dosing phase of the study.||||0.8028
91673404|NCT02610816|183241268|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05|Mixed Models Analysis|||||||<0.0001
91673405|NCT02610816|183241269|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91673406|NCT02610816|183241272|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
91673407|NCT02610816|183241273|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
91673408|NCT02610816|183241274|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|||||||0.36
91673409|NCT02691741|183241283|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193|||TWO_SIDED|90.0|-0.093|-0.029||||||||-0.029|-0.093|
91673410|NCT02691741|183241284|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193||0.002|TWO_SIDED|90.0|-0.093|-0.029|||Repeated Measures Analysis of Variance|||||-0.029|-0.093|0.002
91716359|NCT03387267|183323945|OTHER||AUC under ROC curve|0.576|||||TWO_SIDED|||||||||||||
91716360|NCT04464707|183324037|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.69||0.8484|TWO_SIDED|95.0|-1.48|1.22|||ANCOVA|||||1.22|-1.48|0.8484
91639830|NCT04557189|183171346|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
91639831|NCT00976521|183171433|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.034
91639832|NCT00976521|183171434|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.51
91639833|NCT00951912|183171515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7981|STANDARD_ERROR_OF_MEAN|2.422|<|0.05|TWO_SIDED|95.0|-6.6569|5.0607|||ANOVA|||"Null hypothesis: There are no difference in the difference of changes in plasma glucose.~Power calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate."||5.0607|-6.6569|<0.05
91639834|NCT00951912|183171515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0842|STANDARD_ERROR_OF_MEAN|2.411|<|0.05|TWO_SIDED|95.0|-2.7486|8.9171|||ANOVA|||||8.9171|-2.7486|<0.05
91673411|NCT02691741|183241285|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.019|0.043||||||||0.043|-0.019|
91673412|NCT02691741|183241285|SUPERIORITY|||||||0.455|||||||Repeated Measures Analysis of Variance|||||||0.455
91673413|NCT02691741|183241286|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.0168|||TWO_SIDED|90.0|-0.078|-0.023||||||||-0.023|-0.078|
91716361|NCT04613518|183324051|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-35.7|43.4||||||||43.4|-35.7|
91673414|NCT02691741|183241286|SUPERIORITY|||||||0.003|||||||Repeated Measures Analysis of Variance|||||||0.003
91673415|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.5|||||TWO_SIDED|90.0|-5.41|-1.59|||Mixed Models Analysis|||30 minutes postdose||-1.59|-5.41|
91639835|NCT00951912|183171515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8823|STANDARD_ERROR_OF_MEAN|2.399|<|0.05|TWO_SIDED|95.0|-1.9234|9.6881|||ANOVA|||||9.6881|-1.9234|<0.05
91639836|NCT00951912|183171516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7696|STANDARD_ERROR_OF_MEAN|4.2|<|0.05|TWO_SIDED|95.0|-11.9308|8.3916|||ANOVA|||||8.3916|-11.9308|<0.05
91639837|NCT00951912|183171516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6929|STANDARD_ERROR_OF_MEAN|4.1818|<|0.05|TWO_SIDED|95.0|-9.4232|10.8091|||ANOVA|||||10.8091|-9.4232|<0.05
91639838|NCT00951912|183171516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4626|STANDARD_ERROR_OF_MEAN|4.1624|<|0.05|TWO_SIDED|95.0|-7.6067|12.5318|||ANOVA|||||12.5318|-7.6067|<0.05
91639839|NCT00951912|183171517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01174|STANDARD_ERROR_OF_MEAN|1.45967|<|0.05|TWO_SIDED|95.0|-3.5428|3.5194|||ANOVA|||||3.5194|-3.5428|<0.05
91639840|NCT00951912|183171517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.68659|STANDARD_ERROR_OF_MEAN|1.4532|<|0.05|TWO_SIDED|95.0|-6.202|0.8288|||ANOVA|||||0.8288|-6.2020|<0.05
91639841|NCT00951912|183171517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67485|STANDARD_ERROR_OF_MEAN|1.44646|<|0.05|TWO_SIDED|95.0|-6.174|0.8243|||ANOVA|||||0.8243|-6.174|<0.05
91639842|NCT00951912|183171518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9661|STANDARD_ERROR_OF_MEAN|3.14977|<|0.05|TWO_SIDED|95.0|-10.5857|4.6535|||ANOVA|||||4.6535|-10.5857|<0.05
91639843|NCT00951912|183171518|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.9972|STANDARD_ERROR_OF_MEAN|3.13581|<|0.05|TWO_SIDED|95.0|-8.583|6.5886|||ANOVA|||||6.5886|-8.5830|<0.05
91639844|NCT00951912|183171518|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.9689|STANDARD_ERROR_OF_MEAN|3.12126|<|0.05|TWO_SIDED|95.0|-5.5817|9.5195|||ANOVA|||||9.5195|-5.5817|<0.05
91639845|NCT00951912|183171519|SUPERIORITY_OR_OTHER||Mean Rank|1.442|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91639846|NCT00951912|183171520|SUPERIORITY_OR_OTHER||Mean Ranks|1.895|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91639847|NCT00951912|183171521|SUPERIORITY_OR_OTHER||Mean Ranks|2.169|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91639848|NCT00951912|183171522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.437|STANDARD_ERROR_OF_MEAN|4.9113|<|0.05|TWO_SIDED|95.0|-8.444|15.318|||ANOVA|||||15.318|-8.444|<0.05
91673416|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.54|||||TWO_SIDED|90.0|-5.18|-1.89|||Mixed Models Analysis|||1 hour postdose||-1.89|-5.18|
91673417|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.1|||||TWO_SIDED|90.0|-5.77|-2.43|||Mixed Models Analysis|||1.5 hours postdose||-2.43|-5.77|
91673418|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.21|||||TWO_SIDED|90.0|-5.14|-1.28|||Mixed Models Analysis|||2 hours postdose||-1.28|-5.14|
91716362|NCT02713178|183324185|SUPERIORITY||LSMD|-20.249||||0.4463|TWO_SIDED|95.0|-72.361|31.864|||ANOVA|||||31.864|-72.361|0.4463
91716363|NCT02713178|183324185|SUPERIORITY||LSMD|-28.796||||0.2749|TWO_SIDED|95.0|-80.483|22.892|||ANOVA|||||22.892|-80.483|0.2749
91673419|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.46|||||TWO_SIDED|90.0|-4.41|-0.51|||Mixed Models Analysis|||2.5 hours postdose||-0.51|-4.41|
91673420|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.91|||||TWO_SIDED|90.0|-2.84|1.03|||Mixed Models Analysis|||3 hours postdose||1.03|-2.84|
91673421|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.62|||||TWO_SIDED|90.0|-2.53|1.29|||Mixed Models Analysis|||3.5 hours postdose||1.29|-2.53|
91673422|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.07|||||TWO_SIDED|90.0|-1.84|1.99|||Mixed Models Analysis|||4 hours postdose||1.99|-1.84|
91673423|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.06|||||TWO_SIDED|90.0|-3.22|1.1|||Mixed Models Analysis|||6 hours postdose||1.10|-3.22|
91673424|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.73|||||TWO_SIDED|90.0|-4.88|-0.57|||Mixed Models Analysis|||8 hours postdose||-0.57|-4.88|
91793004|NCT02038829|183463489|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1902|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.1537|0.2268|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2268|0.1537|<0.0001
91673425|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.05|||||TWO_SIDED|90.0|-3.77|-0.32|||Mixed Models Analysis|||12 hours postdose||-0.32|-3.77|
91673426|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.21|||||TWO_SIDED|90.0|-1.9|2.33|||Mixed Models Analysis|||24 hours postdose||2.33|-1.90|
91673427|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.83|||||TWO_SIDED|90.0|-5.56|-2.11|||Mixed Models Analysis|||30 minutes postdose||-2.11|-5.56|
91673428|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.75|||||TWO_SIDED|90.0|-2.75|1.25|||Mixed Models Analysis|||1 hour postdose||1.25|-2.75|
91673429|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.45|||||TWO_SIDED|90.0|-1.49|2.38|||Mixed Models Analysis|||1.5 hours postdose||2.38|-1.49|
91673430|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.58|||||TWO_SIDED|90.0|0.58|4.58|||Mixed Models Analysis|||2 hours postdose||4.58|0.58|
91673431|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.85|||||TWO_SIDED|90.0|0.73|4.98|||Mixed Models Analysis|||2.5 hours postdose||4.98|0.73|
91673432|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.94|||||TWO_SIDED|90.0|1.85|6.03|||Mixed Models Analysis|||3 hours postdose||6.03|1.85|
91673433|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.28|||||TWO_SIDED|90.0|3.61|6.95|||Mixed Models Analysis|||3.5 hours postdose||6.95|3.61|
91673434|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|6.94|||||TWO_SIDED|90.0|4.99|8.89|||Mixed Models Analysis|||4 hours postdose||8.89|4.99|
91673435|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.13|||||TWO_SIDED|90.0|0.93|5.34|||Mixed Models Analysis|||6 hours postdose||5.34|0.93|
91673436|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.09|||||TWO_SIDED|90.0|-0.23|4.4|||Mixed Models Analysis|||8 hours postdose||4.40|-0.23|
91673437|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.37|||||TWO_SIDED|90.0|-0.57|3.3|||Mixed Models Analysis|||12 hours postdose||3.30|-0.57|
91673438|NCT03465436|183241293|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.29|||||TWO_SIDED|90.0|-2.21|1.63|||Mixed Models Analysis|||24 hours postdose||1.63|-2.21|
91673439|NCT03465436|183241293|SUPERIORITY||LS Mean|7.32|||||TWO_SIDED|90.0|5.03|9.6|||Mixed Models Analysis|||30 minutes postdose||9.60|5.03|
91673440|NCT03465436|183241293|SUPERIORITY||LS Mean|12.28|||||TWO_SIDED|90.0|10.47|14.1|||Mixed Models Analysis|||1 hour postdose||14.10|10.47|
91673441|NCT03465436|183241293|SUPERIORITY||LS Mean|11.27|||||TWO_SIDED|90.0|9.54|13.0|||Mixed Models Analysis|||1.5 hours postdose||13.00|9.54|
91673442|NCT03465436|183241293|SUPERIORITY||LS Mean|11.92|||||TWO_SIDED|90.0|9.97|13.87|||Mixed Models Analysis|||2 hours postdose||13.87|9.97|
91673443|NCT03465436|183241293|SUPERIORITY||LS Mean|10.98|||||TWO_SIDED|90.0|9.17|12.79|||Mixed Models Analysis|||2.5 hours postdose||12.79|9.17|
91673444|NCT03465436|183241293|SUPERIORITY||LS Mean|11.99|||||TWO_SIDED|90.0|10.1|13.87|||Mixed Models Analysis|||3 hours postdose||13.87|10.10|
91673445|NCT03465436|183241293|SUPERIORITY||LS Mean|12.19|||||TWO_SIDED|90.0|10.32|14.05|||Mixed Models Analysis|||3.5 hours postdose||14.05|10.32|
91673446|NCT03465436|183241293|SUPERIORITY||LS Mean|11.68|||||TWO_SIDED|90.0|9.83|13.52|||Mixed Models Analysis|||4 hours postdose||13.52|9.83|
91673447|NCT03465436|183241293|SUPERIORITY||LS Mean|8.24|||||TWO_SIDED|90.0|6.1|10.39|||Mixed Models Analysis|||6 hours postdose||10.39|6.10|
91673448|NCT03465436|183241293|SUPERIORITY||LS Mean|7.87|||||TWO_SIDED|90.0|5.66|10.07|||Mixed Models Analysis|||8 hours postdose||10.07|5.66|
91639849|NCT00951912|183171522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4809|STANDARD_ERROR_OF_MEAN|4.8896|<|0.05|TWO_SIDED|95.0|-8.3475|15.3092|||ANOVA|||||15.3092|-8.3475|<0.05
91639850|NCT00951912|183171522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0439|STANDARD_ERROR_OF_MEAN|4.8669|<|0.05|TWO_SIDED|95.0|-11.7296|11.8174|||ANOVA|||||11.8174|-11.7296|<0.05
91639851|NCT00951912|183171523|SUPERIORITY_OR_OTHER||Mean ranks|1.031|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91639852|NCT00951912|183171524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8185|STANDARD_ERROR_OF_MEAN|3.2343|<|0.05|TWO_SIDED|95.0|-6.0057|9.6426|||ANOVA|||||9.6426|-6.0057|<0.05
91639853|NCT00951912|183171524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0276|STANDARD_ERROR_OF_MEAN|3.2199|<|0.05|TWO_SIDED|95.0|-6.7619|8.817|||ANOVA|||||8.8170|-6.7619|<0.05
91639854|NCT00951912|183171524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7909|STANDARD_ERROR_OF_MEAN|3.205|<|0.05|TWO_SIDED|95.0|-8.5442|6.9624|||ANOVA|||||6.9624|-8.5442|<0.05
91639855|NCT00951912|183171525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0122|STANDARD_ERROR_OF_MEAN|4.1686|<|0.05|TWO_SIDED|95.0|-8.0721|12.0964|||ANOVA|||||12.0964|-8.0721|<0.05
91639856|NCT00951912|183171525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7716|STANDARD_ERROR_OF_MEAN|4.1501|<|0.05|TWO_SIDED|95.0|-10.8111|9.2679|||ANOVA|||||9.2679|-10.8111|<0.05
91639857|NCT00951912|183171525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7837|STANDARD_ERROR_OF_MEAN|4.1309|<|0.05|TWO_SIDED|95.0|-12.7767|7.2092|||ANOVA|||||7.2092|-12.7767|<0.05
91639858|NCT00951912|183171526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4437|STANDARD_ERROR_OF_MEAN|0.1001|<|0.05|TWO_SIDED|95.0|-0.6416|-0.2458|||ANOVA|||||-0.2458|-0.6416|<0.05
91639859|NCT00951912|183171526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1986|STANDARD_ERROR_OF_MEAN|0.09986|<|0.05|TWO_SIDED|95.0|-0.3956|-0.0016|||ANOVA|||||-0.0016|-0.3956|<0.05
91639860|NCT00951912|183171526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2451|STANDARD_ERROR_OF_MEAN|0.09648|<|0.05|TWO_SIDED|95.0|0.0544|0.4358|||ANOVA|||||0.4358|0.0544|<0.05
91639861|NCT00951912|183171527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6353|STANDARD_ERROR_OF_MEAN|0.1146|<|0.05|TWO_SIDED|95.0|-0.8617|-0.4089|||ANOVA|||||-0.4089|-0.8617|<0.05
91639862|NCT00951912|183171527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0282|STANDARD_ERROR_OF_MEAN|0.1156||0.05|TWO_SIDED|95.0|-0.2003|0.2568|||ANOVA|||||0.2568|-0.2003|0.05
91639863|NCT00951912|183171527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6635|STANDARD_ERROR_OF_MEAN|0.1121|<|0.05|TWO_SIDED|95.0|0.4419|0.8851|||ANOVA|||||0.8851|0.4419|<0.05
91639864|NCT00951912|183171528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1557|STANDARD_ERROR_OF_MEAN|0.119|<|0.05||95.0|-0.3911|0.0796|||ANOVA|||||0.0796|-0.3911|<0.05
91639865|NCT00951912|183171528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.606|STANDARD_ERROR_OF_MEAN|0.119||0.05|TWO_SIDED|95.0|-0.8414|-0.3707|||ANOVA|||||-0.3707|-0.8414|0.05
91639866|NCT00951912|183171528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4503|STANDARD_ERROR_OF_MEAN|0.1163|<|0.05|TWO_SIDED|95.0|-0.6804|-0.2202|||ANOVA|||||-0.2202|-0.6804|<0.05
91639867|NCT00951912|183171529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.4|STANDARD_ERROR_OF_MEAN|83.4|<|0.05|TWO_SIDED|95.0|-99.3|304.1|||ANOVA|||||304.1|-99.3|<0.05
91639868|NCT00951912|183171529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|82.6||0.05|TWO_SIDED|95.0|-203.7|196.1|||ANOVA|||||196.1|-203.7|0.05
91639869|NCT00951912|183171529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-106.2|STANDARD_ERROR_OF_MEAN|82.2|<|0.05|TWO_SIDED|95.0|-305.1|92.8|||ANOVA|||||92.8|-305.1|<0.05
91639870|NCT01377194|183171542|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.303||||0.0027|TWO_SIDED|95.0|-5.457|-1.148|||mixed-model for repeated measures|||||-1.148|-5.457|0.0027
91639871|NCT01377194|183171542|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.141||||0.0043|TWO_SIDED|95.0|-5.293|-0.988|||mixed-model for repeated measures|||||-0.988|-5.293|0.0043
91639872|NCT01377194|183171543|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.827||||0.0459|TWO_SIDED|95.0|-3.62|-0.033|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.033|-3.620|0.0459
91639873|NCT01377194|183171543|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.72||||0.0028|TWO_SIDED|95.0|-4.494|-0.946|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.946|-4.494|0.0028
91639874|NCT00422227|183171545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91639875|NCT00422227|183171546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 20||||<0.001
91639876|NCT00422227|183171546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 50||||<0.001
91639877|NCT00422227|183171546|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Fisher Exact|||ACR 70||||0.009
91639878|NCT00422227|183171547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Low Disease (DAS28 \<3.2)||||<0.001
91639879|NCT00422227|183171547|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Fisher Exact|||Remission (DAS28 \<2.6)||||0.069
91639880|NCT00422227|183171548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91639881|NCT00422227|183171549|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
91639882|NCT00422227|183171550|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||≥0.6||||0.003
91639883|NCT00422227|183171550|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||≥1.2||||0.001
91639884|NCT00422227|183171551|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||Painful Joints at Week 16||||0.014
91639885|NCT00422227|183171551|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Swollen Joints at Week 16||||<0.001
91639886|NCT00422227|183171552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Physician Global Assessment Week 16||||<0.001
91639887|NCT00422227|183171552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Subject Global Assessment Week 16||||<0.001
91639888|NCT00422227|183171553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Week 16||||<0.001
91639889|NCT00422227|183171554|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||General Health Week 16||||<0.001
91639890|NCT00422227|183171554|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Pain Week 16||||<0.001
91639891|NCT00422227|183171554|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Fatigue Week 16||||0.001
91639892|NCT03747497|183171555|OTHER||Median Difference (Net)|-0.6|||||TWO_SIDED|95.0|-14.0|2.8||||||||2.8|-14.0|
91673449|NCT03465436|183241293|SUPERIORITY||LS Mean|6.35|||||TWO_SIDED|90.0|4.32|8.38|||Mixed Models Analysis|||12 hours postdose||8.38|4.32|
91673450|NCT03465436|183241293|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|3.88|8.38|||Mixed Models Analysis|||24 hours postdose||8.38|3.88|
91716364|NCT02713178|183324186|SUPERIORITY||LSM treatment ratio|0.853||||0.0716|TWO_SIDED|95.0|0.717|1.014|||ANOVA|||||1.014|0.717|0.0716
91673451|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.49|||||TWO_SIDED|90.0|-6.47|-2.52|||Mixed Models Analysis|||30 minutes postdose||-2.52|-6.47|
91673452|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.3|||||TWO_SIDED|90.0|-7.18|-3.42|||Mixed Models Analysis|||1 hour postdose||-3.42|-7.18|
91673453|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.7|||||TWO_SIDED|90.0|-7.57|-3.82|||Mixed Models Analysis|||1.5 hours postdose||-3.82|-7.57|
91673454|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.47|||||TWO_SIDED|90.0|-6.64|-2.3|||Mixed Models Analysis|||2 hours postdose||-2.30|-6.64|
91673455|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.53|||||TWO_SIDED|90.0|-6.87|-2.19|||Mixed Models Analysis|||2.5 hours postdose||-2.19|-6.87|
91673456|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.74|||||TWO_SIDED|90.0|-4.9|-0.59|||Mixed Models Analysis|||3 hours postdose||-0.59|-4.90|
91716365|NCT02713178|183324186|SUPERIORITY||LSM treatment ratio|0.913||||0.3004|TWO_SIDED|95.0|0.769|1.084|||ANOVA|||||1.084|0.769|0.3004
91716366|NCT02713178|183324188|SUPERIORITY|||||||0.1896|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.1896
91673457|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.74|||||TWO_SIDED|90.0|-3.86|0.39|||Mixed Models Analysis|||3.5 hours postdose||0.39|-3.86|
91673458|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.66|||||TWO_SIDED|90.0|-3.77|0.44|||Mixed Models Analysis|||4 hours postdose||0.44|-3.77|
91673459|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.11|||||TWO_SIDED|90.0|-3.17|0.94|||Mixed Models Analysis|||6 hours postdose||0.94|-3.17|
91673460|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.47|||||TWO_SIDED|90.0|-4.58|-0.35|||Mixed Models Analysis|||8 hours postdose||-0.35|-4.58|
91673461|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.15|||||TWO_SIDED|90.0|-3.87|-0.43|||Mixed Models Analysis|||12 hours postdose||-0.43|-3.87|
91673462|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.79|||||TWO_SIDED|90.0|-1.14|2.72|||Mixed Models Analysis|||24 hours postdose||2.72|-1.14|
91673463|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.64|||||TWO_SIDED|90.0|-6.57|-2.71|||Mixed Models Analysis|||30 minutes postdose||-2.71|-6.57|
91673464|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.49|||||TWO_SIDED|90.0|-4.59|-0.39|||Mixed Models Analysis|||1 hour postdose||-0.39|-4.59|
91673465|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.96|||||TWO_SIDED|90.0|-3.02|1.09|||Mixed Models Analysis|||1.5 hours postdose||1.09|-3.02|
91673466|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.64|||||TWO_SIDED|90.0|-0.46|3.73|||Mixed Models Analysis|||2 hours postdose||3.73|-0.46|
91673467|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.61|||||TWO_SIDED|90.0|-0.59|3.81|||Mixed Models Analysis|||2.5 hours postdose||3.81|-0.59|
91673468|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.41|||||TWO_SIDED|90.0|0.25|4.57|||Mixed Models Analysis|||3 hours postdose||4.57|0.25|
91673469|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|4.3|||||TWO_SIDED|90.0|2.48|6.12|||Mixed Models Analysis|||3.5 hours postdose||6.12|2.48|
91673470|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.15|||||TWO_SIDED|90.0|3.02|7.27|||Mixed Models Analysis|||4 hours postdose||7.27|3.02|
91673471|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.77|||||TWO_SIDED|90.0|0.75|4.79|||Mixed Models Analysis|||6 hours postdose||4.79|0.75|
91673472|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.55|4.05|||Mixed Models Analysis|||8 hours postdose||4.05|-0.55|
91673473|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.19|3.69|||Mixed Models Analysis|||12 hours postdose||3.69|-0.19|
91716367|NCT02713178|183324188|SUPERIORITY|||||||0.2549|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.2549
91716368|NCT04414787|183324223|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-6.21|6.21|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (\~1 week post-randomization)||6.21|-6.21|1.00
91716369|NCT04414787|183324224|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.95|TWO_SIDED|95.0|-1.83|1.72|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.72|-1.83|0.95
91716370|NCT04414787|183324225|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.72|TWO_SIDED|95.0|-1.28|1.86|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.86|-1.28|0.72
91716371|NCT04414787|183324226|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.48|TWO_SIDED|95.0|-2.44|5.14|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||5.14|-2.44|0.48
91673474|NCT03465436|183241294|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.48|||||TWO_SIDED|90.0|-2.44|1.48|||Mixed Models Analysis|||24 hours postdose||1.48|-2.44|
91673475|NCT03465436|183241294|SUPERIORITY||LS Mean|7.07|||||TWO_SIDED|90.0|4.72|9.41|||Mixed Models Analysis|||30 minutes postdose||9.41|4.72|
91673476|NCT03465436|183241294|SUPERIORITY||LS Mean|11.81|||||TWO_SIDED|90.0|9.94|13.69|||Mixed Models Analysis|||1 hour postdose||13.69|9.94|
91673477|NCT03465436|183241294|SUPERIORITY||LS Mean|10.95|||||TWO_SIDED|90.0|9.16|12.74|||Mixed Models Analysis|||1.5 hours postdose||12.74|9.16|
91673478|NCT03465436|183241294|SUPERIORITY||LS Mean|11.5|||||TWO_SIDED|90.0|9.5|13.43|||Mixed Models Analysis|||2 hours postdose||13.43|9.5|
91673479|NCT03465436|183241294|SUPERIORITY||LS Mean|10.81|||||TWO_SIDED|90.0|8.9|12.71|||Mixed Models Analysis|||2.5 hours postdose||12.71|8.9|
91673480|NCT03465436|183241294|SUPERIORITY||LS Mean|12.35|||||TWO_SIDED|90.0|10.42|14.28|||Mixed Models Analysis|||3 hours postdose||14.28|10.42|
91673481|NCT03465436|183241294|SUPERIORITY||LS Mean|12.65|||||TWO_SIDED|90.0|10.76|14.54|||Mixed Models Analysis|||3.5 hours postdose||14.54|10.76|
91673482|NCT03465436|183241294|SUPERIORITY||LS Mean|11.17|||||TWO_SIDED|90.0|9.23|13.1|||Mixed Models Analysis|||4 hours postdose||13.10|9.23|
91673483|NCT03465436|183241294|SUPERIORITY||LS Mean|8.12|||||TWO_SIDED|90.0|6.02|10.22|||Mixed Models Analysis|||6 hours postdose||10.22|6.02|
91673484|NCT03465436|183241294|SUPERIORITY||LS Mean|8.1|||||TWO_SIDED|90.0|6.01|10.19|||Mixed Models Analysis|||8 hours postdose||10.19|6.01|
91673485|NCT03465436|183241294|SUPERIORITY||LS Mean|6.26|||||TWO_SIDED|90.0|4.23|8.28|||Mixed Models Analysis|||12 hours postdose||8.28|4.23|
91716372|NCT04414787|183324227|SUPERIORITY||Odds Ratio (OR)|0.49||||0.12|TWO_SIDED|95.0|0.2|1.2|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (target \~1 week post-randomization)||1.2|0.20|0.12
91673486|NCT03465436|183241294|SUPERIORITY||LS Mean|5.74|||||TWO_SIDED|90.0|3.47|8.01|||Mixed Models Analysis|||24 hours postdose||8.01|3.47|
91673487|NCT03465436|183241295|SUPERIORITY||LS Mean|32.89|||||TWO_SIDED|90.0|11.5|54.28|||Mixed Models Analysis|||30 minutes postdose||54.28|11.50|
91673488|NCT03465436|183241295|SUPERIORITY||LS Mean|100.15|||||TWO_SIDED|90.0|77.81|122.5|||Mixed Models Analysis|||1 hour postdose||122.50|77.81|
91673489|NCT03465436|183241295|SUPERIORITY||LS Mean|107.11|||||TWO_SIDED|90.0|83.31|130.91|||Mixed Models Analysis|||1.5 hours postdose||130.91|83.31|
91673490|NCT03465436|183241295|SUPERIORITY||LS Mean|74.48|||||TWO_SIDED|90.0|56.32|92.63|||Mixed Models Analysis|||2 hours postdose||92.63|56.32|
91673491|NCT03465436|183241295|SUPERIORITY||LS Mean|89.19|||||TWO_SIDED|90.0|68.77|109.61|||Mixed Models Analysis|||2.5 hours postdose||109.61|68.77|
91673492|NCT03465436|183241295|SUPERIORITY||LS Mean|74.98|||||TWO_SIDED|90.0|55.41|94.55|||Mixed Models Analysis|||3 hours postdose||94.55|55.41|
91673493|NCT03465436|183241295|SUPERIORITY||LS Mean|52.83|||||TWO_SIDED|90.0|36.03|69.63|||Mixed Models Analysis|||3.5 hours postdose||69.63|36.03|
91673494|NCT03465436|183241295|SUPERIORITY||LS Mean|42.1|||||TWO_SIDED|90.0|24.86|59.35|||Mixed Models Analysis|||4 hours postdose||59.35|24.86|
91673495|NCT03465436|183241295|SUPERIORITY||LS Mean|62.61|||||TWO_SIDED|90.0|42.39|82.83|||Mixed Models Analysis|||6 hours postdose||82.83|42.39|
91673496|NCT03465436|183241295|SUPERIORITY||LS Mean|56.05|||||TWO_SIDED|90.0|32.49|79.61|||Mixed Models Analysis|||8 hours postdose||79.61|32.49|
91673497|NCT03465436|183241295|SUPERIORITY||LS Mean|35.71|||||TWO_SIDED|90.0|11.79|59.63|||Mixed Models Analysis|||12 hours postdose||59.63|11.79|
91673498|NCT03465436|183241295|SUPERIORITY||LS Mean|-4.59|||||TWO_SIDED|90.0|-24.66|15.47|||Mixed Models Analysis|||24 hours postdose||15.47|-24.66|
91673499|NCT03465436|183241295|SUPERIORITY||LS Mean|56.53|||||TWO_SIDED|90.0|36.72|76.35|||Mixed Models Analysis|||30 minutes postdose||76.35|36.72|
91673500|NCT03465436|183241295|SUPERIORITY||LS Mean|103.3|||||TWO_SIDED|90.0|83.88|122.72|||Mixed Models Analysis|||1 hour postdose||122.72|83.88|
91673501|NCT03465436|183241295|SUPERIORITY||LS Mean|94.21|||||TWO_SIDED|90.0|75.15|113.26|||Mixed Models Analysis|||1.5 hours postdose||113.26|75.15|
91673502|NCT03465436|183241295|SUPERIORITY||LS Mean|83.49|||||TWO_SIDED|90.0|67.98|99.0|||Mixed Models Analysis|||2 hours postdose||99.00|67.98|
91673503|NCT03465436|183241295|SUPERIORITY||LS Mean|103.64|||||TWO_SIDED|90.0|87.28|120.0|||Mixed Models Analysis|||2.5 hours postdose||120.00|87.28|
91673504|NCT03465436|183241295|SUPERIORITY||LS Mean|89.26|||||TWO_SIDED|90.0|71.24|107.29|||Mixed Models Analysis|||3 hours postdose||107.29|71.24|
91673505|NCT03465436|183241295|SUPERIORITY||LS Mean|65.29|||||TWO_SIDED|90.0|48.28|82.3|||Mixed Models Analysis|||3.5 hours postdose||82.30|48.28|
91673506|NCT03465436|183241295|SUPERIORITY||LS Mean|52.85|||||TWO_SIDED|90.0|36.1|69.6|||Mixed Models Analysis|||4 hours postdose||69.60|36.10|
91673507|NCT03465436|183241295|SUPERIORITY||LS Mean|86.09|||||TWO_SIDED|90.0|66.36|105.82|||Mixed Models Analysis|||6 hours postdose||105.82|66.36|
91673508|NCT03465436|183241295|SUPERIORITY||LS Mean|80.12|||||TWO_SIDED|90.0|58.32|101.91|||Mixed Models Analysis|||8 hours postdose||101.91|58.32|
91673509|NCT03465436|183241295|SUPERIORITY||LS Mean|67.58|||||TWO_SIDED|90.0|44.64|90.51|||Mixed Models Analysis|||12 hours postdose||90.51|44.64|
91673510|NCT03465436|183241295|SUPERIORITY||LS Mean|7.77|||||TWO_SIDED|90.0|-10.01|25.55|||Mixed Models Analysis|||24 hours postdose||25.55|-10.01|
91673511|NCT03465436|183241295|SUPERIORITY||LS Mean|-22.02|||||TWO_SIDED|90.0|-38.44|-5.6|||Mixed Models Analysis|||30 minutes postdose||-5.60|-38.44|
91673512|NCT03465436|183241295|SUPERIORITY||LS Mean|-38.87|||||TWO_SIDED|90.0|-57.15|-20.6|||Mixed Models Analysis|||1 hour postdose||-20.60|-57.15|
91673513|NCT03465436|183241295|SUPERIORITY||LS Mean|-22.13|||||TWO_SIDED|90.0|-39.35|-4.91|||Mixed Models Analysis|||1.5 hours postdose||-4.91|-39.35|
91673514|NCT03465436|183241295|SUPERIORITY||LS Mean|-17.35|||||TWO_SIDED|90.0|-32.15|-2.56|||Mixed Models Analysis|||2 hours postdose||-2.56|-32.15|
91673515|NCT03465436|183241295|SUPERIORITY||LS Mean|-1.03|||||TWO_SIDED|90.0|-18.17|16.12|||Mixed Models Analysis|||2.5 hours postdose||16.12|-18.17|
91673516|NCT03465436|183241295|SUPERIORITY||LS Mean|-4.77|||||TWO_SIDED|90.0|-21.81|12.27|||Mixed Models Analysis|||3 hours postdose||12.27|-21.81|
91716373|NCT04414787|183324228|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
91716374|NCT04414787|183324229|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91639893|NCT02646566|183171589|SUPERIORITY|||||||0.003||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.003
91639894|NCT02646566|183171589|SUPERIORITY|||||||0.109||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.109
91639895|NCT02646566|183171590|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
91639896|NCT02646566|183171590|SUPERIORITY|||||||0.059||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.059
91639897|NCT02646566|183171591|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
91639898|NCT02646566|183171591|SUPERIORITY|||||||0.053||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.053
91673517|NCT03465436|183241295|SUPERIORITY||LS Mean|-16.56|||||TWO_SIDED|90.0|-33.36|0.24|||Mixed Models Analysis|||3.5 hours postdose||0.24|-33.36|
91673518|NCT03465436|183241295|SUPERIORITY||LS Mean|-15.29|||||TWO_SIDED|90.0|-32.94|2.37|||Mixed Models Analysis|||4 hours postdose||2.37|-32.94|
91716375|NCT04414787|183324230|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91793005|NCT01315236|183463522|SUPERIORITY|||||||0.072||||||Conducted in the mITT population using a stratified Wilcoxon rank sum test, to compare the treatment arms at a 2-sided significance level of 0.05, adjusting for the randomization strata (presence/absence of CF and MAC versus Mycobacterium abscessus).|Wilcoxon rank sum test|||"The primary efficacy analysis tested the following hypotheses:~* H0: There is no difference at Day 84 between the LAI arm and the placebo arm~* Ha: There is a difference at Day 84 between the LAI arm and the placebo arm~Statistical analysis applies to all day 84 rows."||||0.072
91673519|NCT03465436|183241295|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|-10.86|23.11|||Mixed Models Analysis|||6 hours postdose||23.11|-10.86|
91673520|NCT03465436|183241295|SUPERIORITY||LS Mean|2.27|||||TWO_SIDED|90.0|-15.25|19.8|||Mixed Models Analysis|||8 hours postdose||19.80|-15.25|
91673521|NCT03465436|183241295|SUPERIORITY||LS Mean|-11.95|||||TWO_SIDED|90.0|-33.46|9.56|||Mixed Models Analysis|||12 hours postdose||9.56|-33.46|
91673522|NCT03465436|183241295|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-17.32|16.69|||Mixed Models Analysis|||24 hours postdose||16.69|-17.32|
91793006|NCT01315236|183463523|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||stratified Cochran-Mantel-Haenszel test||||0.003
91793007|NCT01315236|183463524|SUPERIORITY||Cox Proportional Hazard|5.68||||0.0129|TWO_SIDED|95.0|1.25|25.79|||Regression, Cox|||Cox proportional hazard model||25.79|1.25|0.0129
91793008|NCT01315236|183463525|SUPERIORITY|||||||0.077|||||||Regression, Logistic|||Ordinal Logistic Regressions Model||||0.077
91639899|NCT02646566|183171592|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
91639900|NCT02646566|183171592|SUPERIORITY|||||||0.021||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.021
91639901|NCT02646566|183171593|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
91639902|NCT02646566|183171593|SUPERIORITY|||||||0.084|||||||Regression, Cox|||||||0.084
91639903|NCT02646566|183171594|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91716376|NCT05093933|183324231|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.219|TWO_SIDED|95.0|0.83|1.04|||Log Rank|Stratified by the randomization stratification factor (NYHA FC)|Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)|||1.04|0.83|0.219
91793009|NCT01315236|183463526|SUPERIORITY|||||||0.4545|||||||Wilcoxon (Mann-Whitney)|||Stratified Wilcoxon-rank sum||||0.4545
91639904|NCT02646566|183171594|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91639905|NCT02646566|183171595|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91639906|NCT02646566|183171595|SUPERIORITY|||||||0.179|||||||Chi-squared|||||||0.179
91639907|NCT02646566|183171596|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
91639908|NCT02646566|183171596|SUPERIORITY|||||||0.315|||||||Chi-squared|||||||0.315
91639909|NCT02646566|183171597|SUPERIORITY|||||||0.065|||||||Chi-squared|||||||0.065
91639910|NCT02646566|183171597|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||0.520
91639911|NCT02646566|183171598|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91639912|NCT02646566|183171598|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
91639913|NCT02646566|183171599|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91673523|NCT03465436|183241296|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.37|0.41|||Mixed Models Analysis|||30 minutes postdose||0.41|-0.37|
91673524|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.23|||||TWO_SIDED|90.0|-0.61|0.15|||Mixed Models Analysis|||1 hour postdose||0.15|-0.61|
91673525|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-0.47|0.23|||Mixed Models Analysis|||1.5 hours postdose||0.23|-0.47|
91673526|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.44|||||TWO_SIDED|90.0|-0.81|-0.07|||Mixed Models Analysis|||2 hours postdose||-0.07|-0.81|
91673527|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-0.95|-0.15|||Mixed Models Analysis|||2.5 hours postdose||-0.15|-0.95|
91673528|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.77|0.0|||Mixed Models Analysis|||3 hours postdose||0.00|-0.77|
91673529|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.41|||||TWO_SIDED|90.0|-0.72|-0.1|||Mixed Models Analysis|||3.5 hours postdose||-0.10|-0.72|
91673530|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.35|||||TWO_SIDED|90.0|-0.66|-0.04|||Mixed Models Analysis|||4 hours postdose||-0.04|-0.66|
91793010|NCT01315236|183463528|SUPERIORITY||Cox Proportional Hazard|2.69||||0.0076|TWO_SIDED|95.0|1.28|5.64|||Regression, Cox|||Cox Proportional Hazard Model||5.64|1.28|0.0076
91793011|NCT03160859|183463549|SUPERIORITY|||||||0.62|||||||Chi-squared|||Chi Square||||0.62
91639914|NCT02646566|183171599|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
91639915|NCT01683331|183171608|SUPERIORITY||Odds Ratio (OR)|1.03||||0.87|TWO_SIDED|95.0|1.01|1.06|||Chi-squared|||||1.06|1.01|0.87
91639916|NCT01683331|183171609|SUPERIORITY||Odds Ratio (OR)|1.3||||0.92|TWO_SIDED|95.0|1.2|2.8|||Chi-squared|||||2.8|1.2|0.92
91639917|NCT01151085|183171680|SUPERIORITY_OR_OTHER||||||=|0.03|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the Frequency of Treatment Related Adverse Events."||||=0.030
91639918|NCT01151085|183171681|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events."||||<0.001
91639919|NCT01151085|183171682|SUPERIORITY_OR_OTHER||||||=|0.017|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events."||||=0.017
91639920|NCT01151085|183171683|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.||||<0.001
91639921|NCT00401726|183171713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.25||||0.218|||||||Chi-squared|||||||0.218
91639922|NCT00401726|183171714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.76||95.0|-0.92|1.25|||ANCOVA|||||1.25|-0.92|0.76
91639923|NCT00401726|183171715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.148||95.0|-0.41|0.06|||ANCOVA|||||0.06|-0.41|0.148
91639924|NCT00401726|183171716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.829||95.0|-1.09|0.87|||ANCOVA|||||0.87|-1.09|0.829
91639925|NCT00401726|183171717|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.57||||0.728|||||||Chi-squared|||||||0.728
91639926|NCT00401726|183171718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.805||95.0|-2.24|1.74|||ANCOVA|||||1.74|-2.24|0.805
91639927|NCT00401726|183171719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.123||95.0|-2.27|0.27|||ANCOVA|||||0.27|-2.27|0.123
91639928|NCT00401726|183171720|SUPERIORITY_OR_OTHER|||||||0.961|||||||Cochran-Mantel-Haenszel|p-value based on comparison of mean score differences||CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.||||0.961
91639929|NCT03948646|183171721|OTHER||Odds Ratio (OR)|2.0||||0.0029|TWO_SIDED|95.0|1.27|3.15|||Regression, Logistic|||||3.15|1.27|0.0029
91639930|NCT03948646|183171722|OTHER||Mean Difference (Net)|-21.77|STANDARD_ERROR_OF_MEAN|9.994||0.0296|TWO_SIDED|95.0|-41.37|-2.16|||ANCOVA|||||-2.16|-41.37|0.0296
91639931|NCT01050998|183171754|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.578|TWO_SIDED|95.0|-11.5|22.0|||Fisher Exact||95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||22.0|-11.5|0.578
91639932|NCT01050998|183171754|SUPERIORITY_OR_OTHER||Percent difference|30.7|||<|0.001|TWO_SIDED|95.0|13.4|46.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||46.3|13.4|<0.001
91639933|NCT01050998|183171754|SUPERIORITY_OR_OTHER||Percent difference|15.3||||0.099|TWO_SIDED|95.0|-1.6|32.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||32.2|-1.6|0.099
91639934|NCT01050998|183171754|SUPERIORITY_OR_OTHER||Percent difference|35.5|||<|0.001|TWO_SIDED|95.0|17.8|50.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||50.6|17.8|<0.001
91673531|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.54|||||TWO_SIDED|90.0|-0.98|-0.09|||Mixed Models Analysis|||6 hours postdose||-0.09|-0.98|
91673532|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.14|||||TWO_SIDED|90.0|-0.58|0.31|||Mixed Models Analysis|||8 hours postdose||0.31|-0.58|
91673533|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.29|||||TWO_SIDED|90.0|-0.7|0.12|||Mixed Models Analysis|||12 hours postdose||0.12|-0.70|
91673534|NCT03465436|183241296|SUPERIORITY||LS Mean|0.43|||||TWO_SIDED|90.0|0.01|0.84|||Mixed Models Analysis|||24 hours postdose||0.84|0.01|
91673535|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.19|||||TWO_SIDED|90.0|-0.59|0.21|||Mixed Models Analysis|||30 minutes postdose||0.21|-0.59|
91673536|NCT03465436|183241296|SUPERIORITY||LS Mean|0.48|||||TWO_SIDED|90.0|0.06|0.89|||Mixed Models Analysis|||1 hour postdose||0.89|0.06|
91673537|NCT03465436|183241296|SUPERIORITY||LS Mean|0.56|||||TWO_SIDED|90.0|0.19|0.93|||Mixed Models Analysis|||1.5 hours postdose||0.93|0.19|
91673538|NCT03465436|183241296|SUPERIORITY||LS Mean|0.4|||||TWO_SIDED|90.0|0.02|0.77|||Mixed Models Analysis|||2 hours postdose||0.77|0.02|
91673539|NCT03465436|183241296|SUPERIORITY||LS Mean|0.51|||||TWO_SIDED|90.0|0.13|0.88|||Mixed Models Analysis|||2.5 hours postdose||0.88|0.13|
91673540|NCT03465436|183241296|SUPERIORITY||LS Mean|0.33|||||TWO_SIDED|90.0|-0.05|0.71|||Mixed Models Analysis|||3 hours postdose||0.71|-0.05|
91673541|NCT03465436|183241296|SUPERIORITY||LS Mean|0.32|||||TWO_SIDED|90.0|-0.02|0.67|||Mixed Models Analysis|||3.5 hours postdose||0.67|-0.02|
91673542|NCT03465436|183241296|SUPERIORITY||LS Mean|0.5|||||TWO_SIDED|90.0|0.16|0.84|||Mixed Models Analysis|||4 hours postdose||0.84|0.16|
91673543|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.56|0.36|||Mixed Models Analysis|||6 hours postdose||0.36|-0.56|
91673544|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.11|||||TWO_SIDED|90.0|-0.56|0.33|||Mixed Models Analysis|||8 hours postdose||0.33|-0.56|
91673545|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.84|0.06|||Mixed Models Analysis|||12 hours postdose||0.06|-0.84|
91673546|NCT03465436|183241296|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|90.0|-0.37|0.45|||Mixed Models Analysis|||24 hours postdose||0.45|-0.37|
91673547|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.45|0.28|||Mixed Models Analysis|||30 minutes postdose||0.28|-0.45|
91673548|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.46|0.27|||Mixed Models Analysis|||1 hour postdose||0.27|-0.46|
91673549|NCT03465436|183241296|SUPERIORITY||LS Mean|0.25|||||TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis|||1.5 hours postdose||0.60|-0.10|
91716377|NCT05093933|183324232|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.02|TWO_SIDED|95.0|0.71|0.97|||Log Rank|Stratified by the randomization stratification factor (NYHA FC)|Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)|||0.97|0.71|0.020
91716378|NCT05093933|183324233|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.509|TWO_SIDED|95.0|0.82|1.1|||Log Rank|Stratified by the randomization stratification factor (NYHA FC)|Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)|||1.10|0.82|0.509
91716379|NCT05093933|183324234|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.094|TWO_SIDED|95.0|0.8|1.02|||Andersen-Gill Model||Based on an Andersen-Gill model controlling for the randomization stratification factor (NYHA FC)|||1.02|0.80|0.094
91716380|NCT05093933|183324235|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.116|TWO_SIDED|95.0|0.82|1.02|||Log Rank|Stratified by the randomization stratification factor (NYHA FC)|Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)|||1.02|0.82|0.116
91716381|NCT05093933|183324236|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.015|TWO_SIDED|95.0|0.74|0.97|||Log Rank|Stratified by the randomization stratification factor (NYHA FC)|Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)|||0.97|0.74|0.015
91716382|NCT05093933|183324240|OTHER||Difference in Percentage|-0.1||||0.512|TWO_SIDED|95.0|-0.4|0.2|||Miettinen and Nurminen|||||0.2|-0.4|0.512
91716383|NCT05093933|183324241|OTHER||Difference in Percentage|2.1||||0.007|TWO_SIDED|95.0|0.6|3.6|||Miettinen and Nurminen|||||3.6|0.6|0.007
91716384|NCT05093933|183324242|OTHER||Difference in Percentage|1.3||||0.045|TWO_SIDED|95.0|0.0|2.6|||Miettinen and Nurminen|||||2.6|0.0|0.045
91716385|NCT04112368|183324243|SUPERIORITY||Slope|-0.02|||<|0.001|TWO_SIDED|95.0|-0.02|-0.02|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.||Fixed interaction effect of treatment (0=Placebo, 1=E2+P4) by cycle phase (0=Lower-Risk Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||-.02|-.02|<.001
91485592|NCT02435069|182844280|SUPERIORITY|||||||0.346594|||||||two-sample pooled variance t test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.346594
91673550|NCT03465436|183241296|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|90.0|-0.38|0.4|||Mixed Models Analysis|||2 hours postdose||0.40|-0.38|
91673551|NCT03465436|183241296|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.34|0.37|||Mixed Models Analysis|||2.5 hours postdose||0.37|-0.34|
91673552|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.44|0.25|||Mixed Models Analysis|||3 hours postdose||0.25|-0.44|
91673553|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.76|-0.03|||Mixed Models Analysis|||3.5 hours postdose||-0.03|-0.76|
91673554|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.73|-0.03|||Mixed Models Analysis|||4 hours postdose||-0.03|-0.73|
91673555|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.6|||||TWO_SIDED|90.0|-1.03|-0.17|||Mixed Models Analysis|||6 hours postdose||-0.17|-1.03|
91673556|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.82|0.04|||Mixed Models Analysis|||8 hours postdose||0.04|-0.82|
91673557|NCT03465436|183241296|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-0.7|0.09|||Mixed Models Analysis|||12 hours postdose||0.09|-0.70|
91673558|NCT03465436|183241296|SUPERIORITY||LS Mean|0.19|||||TWO_SIDED|90.0|-0.23|0.61|||Mixed Models Analysis|||24 hours postdose||0.61|-0.23|
91716386|NCT04112368|183324244|SUPERIORITY||Slope|0.19||||0.026|TWO_SIDED|95.0|0.04|0.82|||Mixed Models Analysis|||Fixed interaction effect of treatment (0=Placebo, 1=E2+P4) by cycle phase (0=Lower-Risk Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.82|.04|.026
91716387|NCT04112368|183324245|SUPERIORITY||Slope|-0.09||||0.052|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|||Fixed interaction effect of treatment (0=Placebo, 1=E2+P4) by cycle phase (0=Lower-Risk Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.00|-.18|.052
91673559|NCT03465436|183241297|SUPERIORITY||LS Mean|-1.53|||||TWO_SIDED|90.0|-2.9|-0.16|||Mixed Models Analysis|||30 minutes postdose||-0.16|-2.90|
91673560|NCT03465436|183241297|SUPERIORITY||LS Mean|-5.09|||||TWO_SIDED|90.0|-6.29|-3.88|||Mixed Models Analysis|||1 hour postdose||-3.88|-6.29|
91673561|NCT03465436|183241297|SUPERIORITY||LS Mean|-5.57|||||TWO_SIDED|90.0|-6.81|-4.32|||Mixed Models Analysis|||1.5 hours postdose||-4.32|-6.81|
91673562|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.01|||||TWO_SIDED|90.0|-5.0|-3.01|||Mixed Models Analysis|||2 hours postdose||-3.01|-5.00|
91673563|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.78|||||TWO_SIDED|90.0|-5.91|-3.65|||Mixed Models Analysis|||2.5 hours postdose||-3.65|-5.91|
91673564|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.14|||||TWO_SIDED|90.0|-5.2|-3.08|||Mixed Models Analysis|||3 hours postdose||-3.08|-5.20|
91673565|NCT03465436|183241297|SUPERIORITY||LS Mean|-2.94|||||TWO_SIDED|90.0|-3.87|-2.01|||Mixed Models Analysis|||3.5 hours postdose||-2.01|-3.87|
91673566|NCT03465436|183241297|SUPERIORITY||LS Mean|-2.42|||||TWO_SIDED|90.0|-3.42|-1.42|||Mixed Models Analysis|||4 hours postdose||-1.42|-3.42|
91673567|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.61|||||TWO_SIDED|90.0|-6.17|-3.06|||Mixed Models Analysis|||6 hours postdose||-3.06|-6.17|
91673568|NCT03465436|183241297|SUPERIORITY||LS Mean|-3.82|||||TWO_SIDED|90.0|-5.38|-2.26|||Mixed Models Analysis|||8 hours postdose||-2.26|-5.38|
91716388|NCT02997163|183324259|SUPERIORITY||Percent Ratio of Geometric Means|112.2|||||TWO_SIDED|90.0|80.06|157.26||||||||157.26|80.06|
91716389|NCT02997163|183324259|SUPERIORITY||Percent Ratio of Geometric Means|142.98|||||TWO_SIDED|90.0|103.03|198.42||||||||198.42|103.03|
91716390|NCT02997163|183324259|SUPERIORITY||Percent Ratio of Geometric Means|263.32|||||TWO_SIDED|90.0|187.88|369.06||||||||369.06|187.88|
91716391|NCT02997163|183324260|SUPERIORITY||Percent Ratio of Geometric Means|111.13|||||TWO_SIDED|90.0|74.4|166.01||||||||166.01|74.40|
91716392|NCT02997163|183324260|SUPERIORITY||Percent Ratio of Geometric Means|131.57|||||TWO_SIDED|90.0|89.12|194.25||||||||194.25|89.12|
91716393|NCT02997163|183324260|SUPERIORITY||Percent Ratio of Geometric Means|189.32|||||TWO_SIDED|90.0|126.74|282.8||||||||282.80|126.74|
91673569|NCT03465436|183241297|SUPERIORITY||LS Mean|-2.65|||||TWO_SIDED|90.0|-4.33|-0.97|||Mixed Models Analysis|||12 hours postdose||-0.97|-4.33|
91673570|NCT03465436|183241297|SUPERIORITY||LS Mean|0.12|||||TWO_SIDED|90.0|-1.22|1.46|||Mixed Models Analysis|||24 hours postdose||1.46|-1.22|
91673571|NCT03465436|183241297|SUPERIORITY||LS Mean|-3.09|||||TWO_SIDED|90.0|-4.16|-2.02|||Mixed Models Analysis|||30 minutes postdose||-2.02|-4.16|
91673572|NCT03465436|183241297|SUPERIORITY||LS Mean|-5.61|||||TWO_SIDED|90.0|-6.65|-4.58|||Mixed Models Analysis|||1 hour postdose||-4.58|-6.65|
91673573|NCT03465436|183241297|SUPERIORITY||LS Mean|-5.39|||||TWO_SIDED|90.0|-6.42|-4.35|||Mixed Models Analysis|||1.5 hours postdose||-4.35|-6.42|
91716394|NCT02997163|183324261|SUPERIORITY||Percent Ratio of Geometric Means|118.58|||||TWO_SIDED|90.0|83.85|167.7||||||||167.70|83.85|
91716395|NCT02997163|183324261|SUPERIORITY||Percent Ratio of Geometric Means|139.34|||||TWO_SIDED|90.0|99.53|195.06||||||||195.06|99.53|
91716396|NCT02997163|183324261|SUPERIORITY||Percent Ratio of Geometric Means|286.61|||||TWO_SIDED|90.0|202.66|405.33||||||||405.33|202.66|
91673574|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.64|||||TWO_SIDED|90.0|-5.55|-3.72|||Mixed Models Analysis|||2 hours postdose||-3.72|-5.55|
91673575|NCT03465436|183241297|SUPERIORITY||LS Mean|-5.82|||||TWO_SIDED|90.0|-6.77|-4.87|||Mixed Models Analysis|||2.5 hours postdose||-4.87|-6.77|
91673576|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.99|||||TWO_SIDED|90.0|-6.03|-3.96|||Mixed Models Analysis|||3 hours postdose||-3.96|-6.03|
91673577|NCT03465436|183241297|SUPERIORITY||LS Mean|-3.69|||||TWO_SIDED|90.0|-4.68|-2.71|||Mixed Models Analysis|||3.5 hours postdose||-2.71|-4.68|
91673578|NCT03465436|183241297|SUPERIORITY||LS Mean|-3.19|||||TWO_SIDED|90.0|-4.21|-2.17|||Mixed Models Analysis|||4 hours postdose||-2.17|-4.21|
91673579|NCT03465436|183241297|SUPERIORITY||LS Mean|-6.29|||||TWO_SIDED|90.0|-7.83|-4.95|||Mixed Models Analysis|||6 hours postdose||-4.95|-7.83|
91673580|NCT03465436|183241297|SUPERIORITY||LS Mean|-5.37|||||TWO_SIDED|90.0|-6.73|-4.02|||Mixed Models Analysis|||8 hours postdose||-4.02|-6.73|
91673581|NCT03465436|183241297|SUPERIORITY||LS Mean|-4.71|||||TWO_SIDED|90.0|-6.25|-3.17|||Mixed Models Analysis|||12 hours postdose||-3.17|-6.25|
91716397|NCT02997163|183324262|SUPERIORITY||Percent Ratio of Geometric Means|117.45|||||TWO_SIDED|90.0|79.74|172.99||||||||172.99|79.74|
91716398|NCT02997163|183324262|SUPERIORITY||Percent Ratio of Geometric Means|128.22|||||TWO_SIDED|90.0|88.05|186.72||||||||186.72|88.05|
91716399|NCT02997163|183324262|SUPERIORITY||Percent Ratio of Geometric Means|206.07|||||TWO_SIDED|90.0|139.91|303.51||||||||303.51|139.91|
91716400|NCT00496769|183324316|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.32|0.62|||Log Rank|||||0.62|0.32|<0.00001
91716401|NCT00496769|183324317|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.00026|TWO_SIDED|95.0|0.53|0.83|||Log Rank||Vascular death|||0.83|0.53|0.00026
91716402|NCT00496769|183324318|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.06782|TWO_SIDED|95.0|0.62|1.02|||Log Rank||All-cause death|||1.02|0.62|0.06782
91716403|NCT00496769|183324318|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0028|TWO_SIDED|95.0|0.6|0.9|||Log Rank||Composite endpoint of major vascular events and major bleeding-net clinical benefit|||0.90|0.60|0.00280
91716404|NCT00496769|183324318|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.36586|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Vascular death|||1.17|0.65|0.36586
91716405|NCT00496769|183324319|OTHER||Hazard Ratio (HR)|1.54||||0.0716|TWO_SIDED|95.0|0.96|2.45|||Log Rank||Major bleeding|||2.45|0.96|0.0716
91716406|NCT00496769|183324319|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank||All bleeding|||1.53|1.10|0.0017
91673582|NCT03465436|183241297|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-1.74|0.63|||Mixed Models Analysis|||24 hours postdose||0.63|-1.74|
91673583|NCT03465436|183241297|SUPERIORITY||LS Mean|1.32|||||TWO_SIDED|90.0|0.32|2.33|||Mixed Models Analysis|||30 minutes postdose||2.33|0.32|
91673584|NCT03465436|183241297|SUPERIORITY||LS Mean|2.29|||||TWO_SIDED|90.0|1.19|3.4|||Mixed Models Analysis|||1 hour postdose||3.40|1.19|
91673585|NCT03465436|183241297|SUPERIORITY||LS Mean|1.3|||||TWO_SIDED|90.0|0.31|2.28|||Mixed Models Analysis|||1.5 hours postdose||2.28|0.31|
91673586|NCT03465436|183241297|SUPERIORITY||LS Mean|1.07|||||TWO_SIDED|90.0|0.17|1.97|||Mixed Models Analysis|||2 hours postdose||1.97|0.17|
91673587|NCT03465436|183241297|SUPERIORITY||LS Mean|0.21|||||TWO_SIDED|90.0|-0.81|1.23|||Mixed Models Analysis|||2.5 hours postdose||1.23|-0.81|
91673588|NCT03465436|183241297|SUPERIORITY||LS Mean|0.53|||||TWO_SIDED|90.0|-0.5|1.56|||Mixed Models Analysis|||3 hours postdose||1.56|-0.50|
91673589|NCT03465436|183241297|SUPERIORITY||LS Mean|1.36|||||TWO_SIDED|90.0|0.29|2.44|||Mixed Models Analysis|||3.5 hours postdose||2.44|0.29|
91673590|NCT03465436|183241297|SUPERIORITY||LS Mean|1.21|||||TWO_SIDED|90.0|0.09|2.34|||Mixed Models Analysis|||4 hours postdose||2.34|0.09|
91673591|NCT03465436|183241297|SUPERIORITY||LS Mean|-0.49|||||TWO_SIDED|90.0|-1.97|0.99|||Mixed Models Analysis|||6 hours postdose||0.99|-1.97|
91673592|NCT03465436|183241297|SUPERIORITY||LS Mean|-0.36|||||TWO_SIDED|90.0|-1.54|0.83|||Mixed Models Analysis|||8 hours postdose||0.83|-1.54|
91673593|NCT03465436|183241297|SUPERIORITY||LS Mean|0.73|||||TWO_SIDED|90.0|-0.87|2.34|||Mixed Models Analysis|||12 hours postdose||2.34|-0.87|
91673594|NCT03465436|183241297|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-1.29|1.04|||Mixed Models Analysis|||24 hours postdose||1.04|-1.29|
91692153|NCT01262872|183279149|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|-3.5|||||TWO_SIDED|95.0|-29.3|17.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||17.2|-29.3|
91716407|NCT00496769|183324319|OTHER||Hazard Ratio (HR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.78|||Log Rank||Major or CNRM bleeding|||1.78|1.07|0.0144
91716408|NCT00496769|183324320|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank|||||1.53|1.10|0.0017
91716409|NCT02308046|183324325|SUPERIORITY|||||||0.002|||||||Chi-squared, Corrected|||||||0.002
91716410|NCT02308046|183324326|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
91716411|NCT02308046|183324327|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 7-14 days||||<0.001
91639935|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.543|TWO_SIDED|95.0|-11.9|25.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||25.4|-11.9|0.543
91639936|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|26.3||||0.011|TWO_SIDED|95.0|7.2|43.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||43.6|7.2|0.011
91639937|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|16.6||||0.108|TWO_SIDED|95.0|-2.5|35.5|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.5|-2.5|0.108
91639938|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|32.0||||0.001|TWO_SIDED|95.0|12.5|49.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||49.0|12.5|0.001
91639939|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
91639940|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
91639941|NCT01050998|183171755|SUPERIORITY_OR_OTHER||Percent difference|9.8||||0.661|TWO_SIDED|95.0|-24.3|46.9|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||46.9|-24.3|0.661
91639942|NCT01050998|183171756|SUPERIORITY_OR_OTHER||Percent difference|13.0||||0.152|TWO_SIDED|95.0|-4.2|30.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||30.3|-4.2|0.152
91639943|NCT01050998|183171756|SUPERIORITY_OR_OTHER||Percent difference|24.3||||0.008|TWO_SIDED|95.0|7.0|40.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||40.3|7.0|0.008
91639944|NCT01050998|183171756|SUPERIORITY_OR_OTHER||Percent difference|21.4||||0.02|TWO_SIDED|95.0|3.9|37.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||37.8|3.9|0.020
91639945|NCT01050998|183171756|SUPERIORITY_OR_OTHER||Percent difference|29.0||||0.002|TWO_SIDED|95.0|11.3|45.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||45.0|11.3|0.002
91639946|NCT01050998|183171757|SUPERIORITY_OR_OTHER||Percent difference|9.9||||0.328|TWO_SIDED|95.0|-9.3|29.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||29.4|-9.3|0.328
91639947|NCT01050998|183171757|SUPERIORITY_OR_OTHER||Percent difference|17.2||||0.084|TWO_SIDED|95.0|-2.0|35.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.6|-2.0|0.084
91639948|NCT01050998|183171757|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.049|TWO_SIDED|95.0|0.7|38.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||38.2|0.7|0.049
91639949|NCT01050998|183171757|SUPERIORITY_OR_OTHER||Percent difference|22.8||||0.03|TWO_SIDED|95.0|3.2|40.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||40.7|3.2|0.030
91639950|NCT01050998|183171757|SUPERIORITY_OR_OTHER||Percent difference|26.8||||0.188|TWO_SIDED|95.0|-9.3|60.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||60.7|-9.3|0.188
91639951|NCT01050998|183171757|SUPERIORITY_OR_OTHER||Percent difference|57.4||||0.01|TWO_SIDED|95.0|15.2|81.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||81.8|15.2|0.010
91639952|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.205||0.137|TWO_SIDED|95.0|-0.71|0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.10|-0.71|0.137
91639953|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.202||0.001|TWO_SIDED|95.0|-1.07|-0.27|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.27|-1.07|0.001
91639954|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.201||0.08|TWO_SIDED|95.0|-0.75|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.04|-0.75|0.080
91639955|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.14|-0.33|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.33|-1.14|<0.001
91793012|NCT01101191|183463553|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|103.0|||||TWO_SIDED|90.0|98.67|106.66|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||106.66|98.67|
91793013|NCT01101191|183463554|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.0|||||TWO_SIDED|90.0|94.2|99.81|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.81|94.20|
91485593|NCT01599832|182844294|OTHER|||||||0.083||||||P-value was from test of significance of log-transformed baseline K\^trans.|Regression, Cox|Multivariate model with adjustment for prior treatment, and clinical prognostic index (good/intermediate/poor) (n=16 had complete data)||||||0.083
91639956|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.212||0.107|TWO_SIDED|95.0|-0.76|0.08|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.08|-0.76|0.107
91639957|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.17|-0.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.35|-1.17|<0.001
91639958|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.209||0.046|TWO_SIDED|95.0|-0.83|-0.01|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.01|-0.83|0.046
91639959|NCT01050998|183171778|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.212|<|0.001|TWO_SIDED|95.0|-1.22|-0.38|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.38|-1.22|<0.001
91639960|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.086|TWO_SIDED|95.0|-0.85|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.06|-0.85|0.086
91639961|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.225||0.016|TWO_SIDED|95.0|-0.99|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.10|-0.99|0.016
91639962|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.225||0.059|TWO_SIDED|95.0|-0.87|0.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.02|-0.87|0.059
91639963|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.227||0.002|TWO_SIDED|95.0|-1.14|-0.25|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.25|-1.14|0.002
91639964|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.241||0.107|TWO_SIDED|95.0|-0.87|0.09|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.09|-0.87|0.107
91639965|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.18|-1.11|0.007
91793014|NCT01101191|183463555|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.1|||||TWO_SIDED|90.0|94.41|99.94|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.94|94.41|
91673595|NCT02697773|183241302|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0129|TWO_SIDED|95.0|-1.07|-0.13||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-1.07|0.0129
91716412|NCT02308046|183324327|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 21-30 days||||<0.001
91793015|NCT04779216|183463561|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91673596|NCT02697773|183241302|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0023|TWO_SIDED|95.0|-1.2|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-1.20|0.0023
91673597|NCT02697773|183241303|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.24||0.0065|TWO_SIDED|95.0|-1.14|-0.19||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-1.14|0.0065
91673598|NCT02697773|183241303|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.37|-0.42||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.37|0.0002
91673599|NCT02697773|183241304|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0109|TWO_SIDED|95.0|-0.39|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.39|0.0109
91673600|NCT02697773|183241304|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0038|TWO_SIDED|95.0|-0.41|-0.08||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.41|0.0038
91673601|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.08|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.08|0.0020
91793016|NCT02674854|183463567|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
91673602|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.1|-0.26|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.10|0.0014
91673603|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.45|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.45|-1.31|<.0001
91673604|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.3|-0.44|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.44|-1.30|<.0001
91716413|NCT02308046|183324328|SUPERIORITY|||||||0.088|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.088
91793017|NCT02674854|183463567|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
91673605|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0085|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.15|-1.03|0.0085
91673606|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0657|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0657
91673607|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.24||0.0012|TWO_SIDED|95.0|-1.25|-0.31|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.31|-1.25|0.0012
91673608|NCT02697773|183241305|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
91673609|NCT02697773|183241307|SUPERIORITY||Least Mean Square Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.17|-0.34|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.17|0.0004
91673610|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.50|-1.33|<.0001
91673611|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.45|-0.6|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.60|-1.45|<.0001
91673612|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.53|-0.68|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.68|-1.53|<.0001
91673613|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0057|TWO_SIDED|95.0|-1.07|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.18|-1.07|0.0057
91673614|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.0114|TWO_SIDED|95.0|-1.02|-0.13|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.13|-1.02|0.0114
91716414|NCT01181167|183324337|NON_INFERIORITY_OR_EQUIVALENCE|"Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.~Incidence of thromboembolic events and 95% CI also calculated by treatment group.~Only when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE."|Cox Proportional Hazard|-4.5|||<|0.001|ONE_SIDED|95.0||||Farrington Manning Method|ANCOVA|||Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (significance level: One-sided, 0.025)||||<0.001
91716415|NCT01573000|183324339|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.0|65.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||65|35|
91716416|NCT01573000|183324339|SUPERIORITY_OR_OTHER||percentage of participants|22.0|||||TWO_SIDED|95.0|9.0|36.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||36|9|
91716417|NCT01573000|183324340|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) before Crossover.|||32|0|
91716418|NCT01573000|183324340|SUPERIORITY_OR_OTHER||percentage of participants|79.0|||||TWO_SIDED|95.0|61.0|97.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) after Crossover.|||97|61|
91716419|NCT01573000|183324341|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|13.0|39.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||39|13|
91716420|NCT01573000|183324341|SUPERIORITY_OR_OTHER||percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|17.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||17|0|
91716421|NCT01573000|183324342|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
91673615|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
91673616|NCT02697773|183241307|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.52|-0.58|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.58|-1.52|<.0001
91673617|NCT02697773|183241309|SUPERIORITY||Least Mean Square Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0236|TWO_SIDED|95.0|-0.32|-0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.02|-0.32|0.0236
91673618|NCT02697773|183241309|SUPERIORITY||Least Square Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0958|TWO_SIDED|95.0|-0.27|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.||0.02|-0.27|0.0958
91673619|NCT02697773|183241309|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07||0.0007|TWO_SIDED|95.0|-0.4|-0.11|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.40|0.0007
91673620|NCT02697773|183241309|SUPERIORITY||Least Mean Square Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.36|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.07|-0.36|0.0040
91673621|NCT02697773|183241309|SUPERIORITY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0498|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.00|-0.31|0.0498
91673622|NCT02697773|183241309|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.238|TWO_SIDED|95.0|-0.24|0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||0.06|-0.24|0.2380
91673623|NCT02697773|183241309|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.0426|TWO_SIDED|95.0|-0.34|-0.01|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.01|-0.34|0.0426
91673624|NCT02697773|183241309|SUPERIORITY||Least Square Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.09||0.0014|TWO_SIDED|95.0|-0.45|-0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.45|0.0014
91716422|NCT01573000|183324343|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed complete response before Crossover.|||0|0|
91716423|NCT01573000|183324343|SUPERIORITY_OR_OTHER||percentage of participants|42.0|||||TWO_SIDED|95.0|20.0|64.0|||||The estimated value represents the percentage of participants with confirmed complete response after Crossover.|||64|20|
91716424|NCT01573000|183324344|SUPERIORITY_OR_OTHER||percentage of participants|2.0|||||TWO_SIDED|95.0|0.0|7.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||7|0|
91639966|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.236||0.084|TWO_SIDED|95.0|-0.88|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.06|-0.88|0.084
91716425|NCT01573000|183324344|SUPERIORITY_OR_OTHER||percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||8|0|
91716426|NCT01573000|183324345|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CCR before Crossover.|||0|0|
91793018|NCT01076075|183463587|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.68|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-0.50|-0.87|<0.001
91793019|NCT01076075|183463588|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-33.5|||<|0.001|TWO_SIDED|95.0|-45.3|-21.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, difference in the Least Squares Means.||-21.7|-45.3|<0.001
91639967|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.238||0.002|TWO_SIDED|95.0|-1.2|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.26|-1.20|0.002
91639968|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.447||0.785|TWO_SIDED|95.0|-0.78|1.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||1.02|-0.78|0.785
91639969|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.465||0.014|TWO_SIDED|95.0|-2.13|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.26|-2.13|0.014
91639970|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.448||0.931|TWO_SIDED|95.0|-0.94|0.86|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.86|-0.94|0.931
91639971|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.465||0.07|TWO_SIDED|95.0|-1.8|0.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.07|-1.80|0.070
91639972|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.449||0.854|TWO_SIDED|95.0|-0.99|0.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.82|-0.99|0.854
91639973|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.468||0.011|TWO_SIDED|95.0|-2.19|-0.31|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.31|-2.19|0.011
91639974|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.448||0.271|TWO_SIDED|95.0|-1.4|0.4|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.40|-1.40|0.271
91639975|NCT01050998|183171779|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.465||0.031|TWO_SIDED|95.0|-1.97|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.10|-1.97|0.031
91639976|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|7.0||||0.238|TWO_SIDED|95.0|-3.3|20.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||20.5|-3.3|0.238
91716427|NCT01573000|183324345|SUPERIORITY_OR_OTHER||percentage of participants|5.0|||||TWO_SIDED|95.0|0.0|15.0|||||The estimated value represents the percentage of participants with confirmed CCR after Crossover.|||15|0|
91716428|NCT01573000|183324346|SUPERIORITY_OR_OTHER||percentage of participants|31.0|||||TWO_SIDED|95.0|17.0|45.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||45|17|
91793020|NCT01076075|183463589|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.6|||<|0.001|TWO_SIDED|95.0|-26.4|-10.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-10.7|-26.4|<0.001
91673625|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0027|TWO_SIDED|95.0|1.22|2.61|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.61|1.22|0.0027
91673626|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0004|TWO_SIDED|95.0|1.36|2.89|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.36|0.0004
91673627|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0008|TWO_SIDED|95.0|1.33|2.95|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.95|1.33|0.0008
91673628|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.37|3.04|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.37|0.0004
91673629|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.27||||0.2283|TWO_SIDED|95.0|0.86|1.87|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.87|0.86|0.2283
91673630|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|0.93|2.03|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.03|0.93|0.1066
91673631|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0154|TWO_SIDED|95.0|1.1|2.54|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.10|0.0154
91673632|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0006|TWO_SIDED|95.0|1.38|3.27|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|1.38|0.0006
91673633|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1139|TWO_SIDED|95.0|0.92|2.07|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.07|0.92|0.1139
91673634|NCT02697773|183241311|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0014|TWO_SIDED|95.0|1.31|3.04|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.31|0.0014
91673635|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.3|2.78|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.30|0.0009
91673636|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0004|TWO_SIDED|95.0|1.36|2.9|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.90|1.36|0.0004
91673637|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0015|TWO_SIDED|95.0|1.29|2.96|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.29|0.0015
91673638|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
91673639|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0251|TWO_SIDED|95.0|1.07|2.75|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.07|0.0251
91673640|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0276|TWO_SIDED|95.0|1.06|2.72|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.06|0.0276
91716429|NCT01573000|183324346|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
91793021|NCT03326206|183463615|SUPERIORITY||||||<|0.0001||||||A priori threshold for statistical significance \< 0.05|Regression, Linear|Mixed linear regression||Mixed linear regression models were performed to assess differences over time for continuous variables, comparing COPE versus control groups. The models included a random effect for patients to account for within-patient correlation over time in the outcome measures and a random effect for the primary health facility, to account for within-site correlation. In the sensitivity analyses we also adjusted the models for the random effect of matching groups.||||<0.0001
91793022|NCT03326206|183463616|SUPERIORITY|||||||0.004||||||a priori threshold for significance p\<0.05|Regression, Linear|Mixed linear regression as described in primary endpoint||||||0.004
91793023|NCT03326206|183463617|SUPERIORITY|||||||0.02||||||a priori threshold for significant p\<0.05|Regression, Linear|Mixed linear regression as described in primary endpoint||||||0.02
91793024|NCT03326206|183463618|SUPERIORITY|||||||0.93||||||a priori threshold for significance p\<0.05|Regression, Linear|Mixed linear regression model as described for primary endpoint||||||0.93
91793025|NCT03326206|183463619|SUPERIORITY|||||||0.0091||||||Primary result is coefficient on post intervention change in visits by COPE pts relative to controls: if significant and \>0, COPE visits have increased relative to controls; if significant and \<0, COPE visits have decreased relative to controls.|Regression, Linear|||Generalized linear mixed regression models were used for count outcomes (SAS 9.3: PROC GLIMMIX) to estimate change in health care visits by COPE pts relative to non-COPE pts. Random effects accounted for within-site correlation at service units. Adjusted for covariates: age, gender, language, primary care physician, and diagnoses: essential hypertension, major depression disorder, alcohol abuse, major cardiovascular disease, and dyslipidemia.||||0.0091
91793026|NCT03326206|183463620|SUPERIORITY|||||||0.0003|||||||Regression, Linear|||As described for primary outpatient services||||0.0003
91639977|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|14.8||||0.017|TWO_SIDED|95.0|2.8|29.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||29.7|2.8|0.017
91793027|NCT03326206|183463621|SUPERIORITY|||||||0.4296|||||||Regression, Linear|||as described for primary outpatient services||||0.4296
91485594|NCT00932737|182844308|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0156|TWO_SIDED|95.0|-1.3|-0.1|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||-0.1|-1.3|0.0156
91485595|NCT00932737|182844309|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0512|TWO_SIDED|95.0|-1.2|0.0|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||0.0|-1.2|0.0512
91639978|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.09|TWO_SIDED|95.0|0.0|25.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||25.4|0.0|0.090
91793028|NCT03326206|183463622|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||As described for primary outpatient services||||<0.0001
91793029|NCT03326206|183463623|SUPERIORITY|||||||0.0431|||||||Regression, Linear|||||||0.0431
91793030|NCT03326206|183463624|SUPERIORITY|||||||0.0516|||||||Regression, Linear|||||||0.0516
91793031|NCT03326206|183463625|SUPERIORITY|||||||0.3582|||||||Regression, Linear|||||||0.3582
91793032|NCT03326206|183463626|SUPERIORITY|||||||0.2461|||||||Regression, Linear|||||||0.2461
91793033|NCT03326206|183463627|SUPERIORITY|||||||0.0613|||||||Regression, Linear|||||||0.0613
91639979|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|15.8||||0.015|TWO_SIDED|95.0|2.9|31.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||31.0|2.9|0.015
91639980|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|3.0||||0.412|TWO_SIDED|95.0|-4.2|14.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.0|-4.2|0.412
91793034|NCT03326206|183463628|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||||||<0.0001
91793035|NCT03326206|183463629|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
91793036|NCT03326206|183463630|SUPERIORITY|||||||0.19||||||P-value corresponds to patient-reported health compared to a year ago and compared to others their age|Chi-squared|||||||0.19
91793037|NCT03326206|183463631|SUPERIORITY|||||||0.0028||||||P value corresponds with Ability to cope with negative life events|Fisher Exact|||||||0.0028
91793038|NCT04770753|183463680|SUPERIORITY||Percentage difference|40.9|||<|0.0001|TWO_SIDED|95.0|32.0|49.8|||Cochran-Mantel-Haenszel|||The estimated adjusted difference in response rate, 95% CI, and p-value are based on Mantel-Haenszel stratum weighted method adjusting for the randomization stratification factors.||49.8|32.0|<0.0001
91793039|NCT04770753|183463681|SUPERIORITY||Difference in Lean Square (LS) Mean|3.4||||0.0026|TWO_SIDED|95.0|1.21|5.59|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an analysis of covariance (ANCOVA) model which includes average change from baseline in FACIT-Fatigue subscale score from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline and the randomization stratification factors as covariates.||5.59|1.21|0.0026
91793040|NCT04770753|183463682|SUPERIORITY||Difference in LS Mean|9.63|||<|0.0001|TWO_SIDED|95.0|7.8|11.46|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an ANCOVA model which includes average change from baseline in Hb concentrations from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline Hb concentration and the randomization stratification factors as covariates.||11.46|7.80|<0.0001
91793041|NCT05281510|183463718|OTHER|||||||0.002|||||||Wilcoxon signed rank test|||The comparison was between plasma viral HIV-1 RNA data at set-point and at pre-ART within the same treatment group.||||0.0020
91639981|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.237|TWO_SIDED|95.0|-2.9|16.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.4|-2.9|0.237
91639982|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|5.1||||0.231|TWO_SIDED|95.0|-2.8|16.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.8|-2.8|0.231
91639983|NCT01050998|183171780|SUPERIORITY_OR_OTHER||Percent difference|3.1||||0.406|TWO_SIDED|95.0|-4.1|14.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.4|-4.1|0.406
91639984|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|8.7||||0.182|TWO_SIDED|95.0|-2.7|24.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||24.4|-2.7|0.182
91639985|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|10.4||||0.11|TWO_SIDED|95.0|-1.2|25.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||25.5|-1.2|0.110
91639986|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|11.3||||0.104|TWO_SIDED|95.0|-0.6|26.9|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||26.9|-0.6|0.104
91639987|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|16.4||||0.016|TWO_SIDED|95.0|3.5|32.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||32.7|3.5|0.016
91639988|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.115|TWO_SIDED|95.0|-1.0|19.3|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||19.3|-1.0|0.115
91639989|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|8.4||||0.052|TWO_SIDED|95.0|0.6|21.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||21.6|0.6|0.052
91639990|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
91639991|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
91639992|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|10.5||||0.591|TWO_SIDED|95.0|-18.2|46.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||46.2|-18.2|0.591
91639993|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|13.2||||0.57|TWO_SIDED|95.0|-16.6|51.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||51.4|-16.6|0.570
91639994|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
91793042|NCT03563716|183463768|SUPERIORITY||Odds Ratio (OR)|2.57|||||TWO_SIDED|95.0|1.07|6.14|||||95% CI for odds ratio was constructed using the Wald method.|Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.||6.14|1.07|
91639995|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
91639996|NCT01050998|183171781|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
91639997|NCT01050998|183171782|SUPERIORITY_OR_OTHER||Percent difference|||||0.604|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.604
91639998|NCT01050998|183171782|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||<0.001
91639999|NCT01050998|183171782|SUPERIORITY_OR_OTHER|||||||0.145|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.145
91640000|NCT01050998|183171782|SUPERIORITY_OR_OTHER|||||||0.282|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.282
91640001|NCT01050998|183171782|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||<0.001
91640002|NCT01050998|183171782|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.047
91640003|NCT01050998|183171783|SUPERIORITY_OR_OTHER||Percent difference|||||0.237|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.237
91640004|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.005
91640005|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.134|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.134
91640006|NCT01050998|183171783|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||<0.001
91640007|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.265|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.265
91640008|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.013|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.013
91640009|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.952|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.952
91716430|NCT01573000|183324347|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR before Crossover.|||0|0|
91716431|NCT01573000|183324347|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|25.0|70.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR after Crossover.|||70|25|
91793043|NCT03563716|183463769|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.37|0.9|||||Hazard ratios were estimated by Cox regression.|Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.||0.90|0.37|
91793044|NCT04001829|183463780|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
91793045|NCT04001829|183463781|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
91793046|NCT04001829|183463782|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
91640010|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.004|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.004
91793047|NCT04001829|183463783|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91640011|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.246|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.246
91640012|NCT01050998|183171783|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||<0.001
91640013|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.126
91640014|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.831|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.831
91640015|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.005
91640016|NCT01050998|183171783|SUPERIORITY_OR_OTHER|||||||0.125|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.125
91640017|NCT01050998|183171783|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||<0.001
91640018|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.15||||0.486|TWO_SIDED|95.0|0.78|1.69|||Exponential,Weibull and Log normal model||Ratio greater than (\>) 1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||1.69|0.78|0.486
91640019|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.54||||0.015|TWO_SIDED|95.0|1.09|2.18|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.18|1.09|0.015
91640020|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.65||||0.006|TWO_SIDED|95.0|1.15|2.36|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.36|1.15|0.006
91640021|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|2.09|||<|0.001|TWO_SIDED|95.0|1.49|2.93|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.93|1.49|<0.001
91640022|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|0.97||||0.906|TWO_SIDED|95.0|0.61|1.55|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.55|0.61|0.906
91640023|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.89|||<|0.001|TWO_SIDED|95.0|1.31|2.71|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.71|1.31|<0.001
91640024|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.26||||0.272|TWO_SIDED|95.0|0.83|1.91|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.91|0.83|0.272
91640025|NCT01050998|183171784|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.91|||<|0.001|TWO_SIDED|95.0|1.34|2.72|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.72|1.34|<0.001
91640026|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.589|TWO_SIDED|95.0|-12.1|22.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||22.0|-12.1|0.589
91640027|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.032||95.0|2.8|36.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||36.7|2.8|0.032
91640028|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|0.5||||1|TWO_SIDED|95.0|-16.0|18.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||18.0|-16.0|1.000
91640029|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|33.3|||<|0.001|TWO_SIDED|95.0|15.6|48.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||48.6|15.6|<0.001
91640030|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|8.9||||0.212|TWO_SIDED|95.0|-3.5|23.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||23.6|-3.5|0.212
91640031|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|18.7||||0.011|TWO_SIDED|95.0|4.8|34.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||34.0|4.8|0.011
91640032|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.446|TWO_SIDED|95.0|-7.0|19.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||19.1|-7.0|0.446
91640033|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|22.1||||0.003|TWO_SIDED|95.0|7.6|37.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||37.8|7.6|0.003
91640034|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-8.9|9.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||9.7|-8.9|1.000
91640035|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|4.8||||0.317|TWO_SIDED|95.0|-4.1|17.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||17.5|-4.1|0.317
91640036|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|0.8||||1|TWO_SIDED|95.0|-7.2|12.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||12.1|-7.2|1.000
91640037|NCT01050998|183171785|SUPERIORITY_OR_OTHER||Percent difference|9.5||||0.106|TWO_SIDED|95.0|-0.5|23.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||23.5|-0.5|0.106
91640038|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
91640039|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|16.1||||0.12|TWO_SIDED|95.0|-3.1|34.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||34.4|-3.1|0.120
91640040|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
91640041|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|29.2||||0.005|TWO_SIDED|95.0|9.7|46.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||46.1|9.7|0.005
91640042|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|20.9||||0.382|TWO_SIDED|95.0|-16.4|55.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||55.9|-16.4|0.382
91640043|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|39.0||||0.087|TWO_SIDED|95.0|-2.7|69.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||69.6|-2.7|0.087
91640044|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
91640045|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
91640046|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.175|TWO_SIDED|95.0|-2.9|27.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||27.9|-2.9|0.175
91640047|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|17.3||||0.026|TWO_SIDED|95.0|2.4|34.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.1|2.4|0.026
91640048|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|8.5||||0.271|TWO_SIDED|95.0|-5.1|24.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||24.9|-5.1|0.271
91640049|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|18.8||||0.021|TWO_SIDED|95.0|3.4|36.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||36.0|3.4|0.021
91640050|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
91640051|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|25.7||||0.283|TWO_SIDED|95.0|-8.8|63.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||63.2|-8.8|0.283
91673641|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0404|TWO_SIDED|95.0|1.03|3.71|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.71|1.03|0.0404
91673642|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3486|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|0.70|0.3486
91673643|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.42|3.02|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.42|0.0002
91793048|NCT04001829|183463784|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
91527856|NCT06173570|182930694|SUPERIORITY||Mean Difference (Net)|-28.99|||<|0.001|TWO_SIDED|95.0|-37.16|-20.81|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-20.81|-37.16|<0.001
91640052|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
91673644|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0006|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.32|0.0006
91640053|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
91640054|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-7.0|14.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||14.2|-7.0|1.000
91640055|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|5.8||||0.242|TWO_SIDED|95.0|-3.7|19.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||19.4|-3.7|0.242
91640056|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.41|TWO_SIDED|95.0|-5.1|16.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||16.9|-5.1|0.410
91640057|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|13.9||||0.03|TWO_SIDED|95.0|2.7|29.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||29.5|2.7|0.030
91640058|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
91640059|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|0.7||||1|TWO_SIDED|95.0|-26.7|39.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||39.5|-26.7|1.000
91640060|NCT01050998|183171786|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
91640061|NCT01050998|183171788|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.05|STANDARD_ERROR_OF_MEAN|7.162||0.051|TWO_SIDED|95.0|-0.05|28.15|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.15|-0.05|0.051
91640062|NCT01050998|183171788|SUPERIORITY_OR_OTHER||Adjusted Mean difference|21.23|STANDARD_ERROR_OF_MEAN|7.028||0.003|TWO_SIDED|95.0|7.39|35.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||35.07|7.39|0.003
91640063|NCT01050998|183171788|SUPERIORITY_OR_OTHER||Adjusted Mean difference|7.09|STANDARD_ERROR_OF_MEAN|7.136||0.322|TWO_SIDED|95.0|-6.96|21.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||21.14|-6.96|0.322
91793049|NCT04001829|183463785|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
91640064|NCT01050998|183171788|SUPERIORITY_OR_OTHER||Adjusted Mean difference|32.03|STANDARD_ERROR_OF_MEAN|7.085|<|0.001|TWO_SIDED|95.0|18.08|45.98|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||45.98|18.08|<0.001
91640065|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.49|STANDARD_ERROR_OF_MEAN|7.981||0.071|TWO_SIDED|95.0|-1.24|30.22|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||30.22|-1.24|0.071
91640066|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|19.43|STANDARD_ERROR_OF_MEAN|7.798||0.013|TWO_SIDED|95.0|4.06|34.8|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||34.80|4.06|0.013
91640067|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.84|STANDARD_ERROR_OF_MEAN|7.873||0.32|TWO_SIDED|95.0|-7.68|23.36|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||23.36|-7.68|0.320
91793050|NCT06415305|183463828|SUPERIORITY||||||<|0.008|||||||Wilcoxon signed rank tests|||||||<0.008
91673645|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.41|3.05|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.05|1.41|0.0002
91673646|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.46|3.15|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.15|1.46|<.0001
91673647|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0024|TWO_SIDED|95.0|1.28|3.18|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.18|1.28|0.0024
91673648|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0011|TWO_SIDED|95.0|1.35|3.34|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.34|1.35|0.0011
91673649|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0172|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0172
91673650|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0173|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0173
91716432|NCT01573000|183324348|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|5.0|28.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||28|5|
91673651|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0118|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|1.11|0.0118
91673652|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0132|TWO_SIDED|95.0|1.1|2.32|||Regression, Logistic|||Week 8, \>=30%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.32|1.10|0.0132
91673653|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0005|TWO_SIDED|95.0|1.35|2.92|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.92|1.35|0.0005
91673654|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.66||||0.01|TWO_SIDED|95.0|1.13|2.45|||Regression, Logistic|||Week 8, \>=50%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.13|0.0100
91673655|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0023|TWO_SIDED|95.0|1.28|3.12|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.12|1.28|0.0023
91673656|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0322|TWO_SIDED|95.0|1.04|2.58|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.04|0.0322
91673657|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2005|TWO_SIDED|95.0|0.81|2.67|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|0.81|0.2005
91673658|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1923|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|0.82|0.1923
91673659|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0013|TWO_SIDED|95.0|1.28|2.79|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.28|0.0013
91793051|NCT06415305|183463829|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
91793052|NCT06415305|183463830|SUPERIORITY|||||||0.008|||||||Wilcoxon signed rank tests|||||||0.008
91716433|NCT01573000|183324348|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
91793053|NCT06415305|183463831|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
91793054|NCT04103346|183463844|SUPERIORITY|||||||0.588|||||||Mixed Effects Model|||||||0.588
91793055|NCT04103346|183463845|SUPERIORITY|||||||0.748|||||||Mixed Effects Model|||||||0.748
91793056|NCT04103346|183463846|SUPERIORITY||||||<|0.001|||||||Mixed Effects Model|||||||<0.001
91793057|NCT04103346|183463847|SUPERIORITY|||||||0.0764|||||||Mixed Effects Model|||||||0.0764
91673660|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.68|3.73|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.73|1.68|<.0001
91673661|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.45|3.1|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.45|<.0001
91716434|NCT01573000|183324349|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
91640068|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.37|STANDARD_ERROR_OF_MEAN|7.873|<|0.001|TWO_SIDED|95.0|15.85|46.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||46.89|15.85|<0.001
91640069|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|12.11|STANDARD_ERROR_OF_MEAN|17.089||0.483|TWO_SIDED|95.0|-22.41|46.64|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||46.64|-22.41|0.483
91640070|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.24|STANDARD_ERROR_OF_MEAN|17.089||0.075|TWO_SIDED|95.0|-3.28|65.77|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||65.77|-3.28|0.075
91640071|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22|STANDARD_ERROR_OF_MEAN|17.872||0.815|TWO_SIDED|95.0|-31.89|40.32|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||40.32|-31.89|0.815
91640072|NCT01050998|183171789|SUPERIORITY_OR_OTHER||Adjusted mean difference|36.11|STANDARD_ERROR_OF_MEAN|17.089||0.041|TWO_SIDED|95.0|1.58|70.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||70.63|1.58|0.041
91640073|NCT00370994|183171819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Comparisons were made between groups and within the group between baseline and different time points.|Repeated measures ANOVA.|||||||<0.001
91640074|NCT00370994|183171820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||There were significant differences in Oswestry Disability Index between both groups|Repeated measures of ANOVA|||||||0.001
91640075|NCT04246593|183171821|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites. In order to further explore the intervention effect, we fit GLMMs that adjust for (1) baseline dietary intake and (2) race and baseline income.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.52||0.84|TWO_SIDED|||||P-value calculated for the mean difference between the user and non-user groups.|GLMM|||||||0.84
91640076|NCT04246593|183171822|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Median Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.61|TWO_SIDED|||||P-value calculated for the mean difference between change in BMI for intervention and control groups.|GLMM|||||||0.61
91640077|NCT04246593|183171823|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-28.02|STANDARD_ERROR_OF_MEAN|43.31||0.53|TWO_SIDED|||||P-value calculated for the mean difference in change scores between the intervention and control groups.|GLMM|||||||0.53
91640078|NCT04246593|183171824|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|1.65||0.75|TWO_SIDED|||||The p-value applies to the mean difference in mean self-efficacy change scores between the intervention and control groups.|GLMM|||||||0.75
91640079|NCT04246593|183171825|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|1.13||0.63|TWO_SIDED|||||P-value applies to the mean difference in mean total barriers score change between the intervention and control groups.|GLMM|||||||0.63
91640080|NCT04278846|183171826|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
91640081|NCT04278846|183171827|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
91640082|NCT04278846|183171828|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||.57
91640083|NCT04278846|183171829|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||||||.3
91716435|NCT01573000|183324351|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Log Rank|||||||0.495
91640084|NCT04278846|183171830|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||.99
91640085|NCT04278846|183171831|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||.33
91640086|NCT04278846|183171832|SUPERIORITY|||||||0.26|||||||Kruskal-Wallis|||||||.26
91640087|NCT04278846|183171833|SUPERIORITY|||||||0.79|||||||Kruskal-Wallis|||||||.79
91640088|NCT04278846|183171834|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
91640089|NCT04278846|183171835|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||.94
91640090|NCT04278846|183171836|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
91640091|NCT04278846|183171837|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||.54
91640092|NCT04278846|183171838|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
91640093|NCT04278846|183171839|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||.96
91640094|NCT04278846|183171841|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||.088
91640095|NCT04278846|183171842|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||.42
91640096|NCT04278846|183171843|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||.88
91640097|NCT04278846|183171845|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||.12
91640098|NCT04278846|183171846|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
91716436|NCT01573000|183324352|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Log Rank|||||||0.677
91716437|NCT01573000|183324355|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||Log Rank|||||||0.119
91716438|NCT01573000|183324356|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Log Rank|||||||0.016
91716439|NCT01573000|183324369|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed PR before Crossover.|||32|0|
91716440|NCT01573000|183324369|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|11.0|52.0|||||The estimated value represents the percentage of participants with confirmed PR after Crossover.|||52|11|
91716441|NCT01450813|183324421|NON_INFERIORITY_OR_EQUIVALENCE|Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.|||||<|0.05||||||Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.|ANOVA|||Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.||||< 0.05
91716442|NCT00752089|183324441|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.146||||0.7756|TWO_SIDED|95.0|-6.904|9.196||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||9.196|-6.904|0.7756
91793058|NCT04103346|183463848|SUPERIORITY||||||<|0.001|||||||Mixed Effects Model|||||||<0.001
91640099|NCT04278846|183171847|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||.76
91793059|NCT05380180|183463853|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.||||<.05
91640100|NCT04278846|183171848|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
91640101|NCT04278846|183171849|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||.37
91640102|NCT00796367|183171951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71|STANDARD_ERROR_OF_MEAN|0.673|<|0.0001|TWO_SIDED|95.0|7.39|10.03||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||10.03|7.39|<0.0001
91640103|NCT00796367|183171951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.52|STANDARD_ERROR_OF_MEAN|0.799|<|0.0001|TWO_SIDED|95.0|5.95|9.09||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||9.09|5.95|<0.0001
91640104|NCT00796367|183171951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|0.76||0.1189|TWO_SIDED|95.0|-0.31|2.68||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.68|-0.31|0.1189
91640105|NCT00796367|183171952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|6.24|14.16||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||14.16|6.24|<0.0001
91640106|NCT00796367|183171952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|4.36|11.19||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||11.19|4.36|<0.0001
91640107|NCT00796367|183171952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|STANDARD_ERROR_OF_MEAN|0.32||0.2169|TWO_SIDED|95.0|0.84|2.15|||Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.15|0.84|0.2169
91640108|NCT04604015|183171969|OTHER||absolute difference|41.0|||<|0.001|TWO_SIDED|95.0|32.9|50.2|||McNemar|||The study was powered based on the results of a meta-analysis reporting the pooled NeuralBot (TCD) sensitivity for Right to Left Shunt detection, and the pooled TTE sensitivity for Right to Left Shunt detection.||50.2|32.9|<0.001
91640109|NCT02129192|183171970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|95.77|||||TWO_SIDED|90.0|88.89|103.17|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.17|88.89|
91640110|NCT02129192|183171970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.4|||||TWO_SIDED|90.0|99.7|103.13|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.13|99.70|
91640111|NCT02129192|183171970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.77|||||TWO_SIDED|90.0|98.46|105.19|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||105.19|98.46|
91640112|NCT02129192|183171971|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|30.15||||1|TWO_SIDED|90.0|24.99|36.38|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||36.38|24.99|1.0000
91716443|NCT00752089|183324441|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.291||||0.4194|TWO_SIDED|95.0|-4.84|11.421||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||11.421|-4.840|0.4194
91716444|NCT00752089|183324441|SUPERIORITY_OR_OTHER||Adjusted mean difference|22.2|||<|0.0001|TWO_SIDED|95.0|14.28|30.12||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||30.120|14.280|<0.0001
91716445|NCT00752089|183324441|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.145||||0.5927|TWO_SIDED|95.0|-5.874|10.164||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||10.164|-5.874|0.5927
91716446|NCT00752089|183324441|SUPERIORITY_OR_OTHER||Adjusted mean difference|21.054|||<|0.0001|TWO_SIDED|95.0|13.189|28.919||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||28.919|13.189|<0.0001
91793060|NCT05380180|183463854|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.||||<.05
91640113|NCT02129192|183171971|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|98.23|||<|0.0001|TWO_SIDED|90.0|94.63|101.97|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||101.97|94.63|<0.0001
91716447|NCT00752089|183324441|SUPERIORITY_OR_OTHER||Adjusted mean difference|18.909|||<|0.0001|TWO_SIDED|95.0|11.036|26.783||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||26.783|11.036|<0.0001
91640114|NCT02129192|183171971|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|79.69||||0.5422|TWO_SIDED|90.0|74.97|84.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||84.71|74.97|0.5422
91640115|NCT02129192|183171972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|99.21|||||TWO_SIDED|90.0|96.14|102.38|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||102.38|96.14|
91640116|NCT02129192|183171972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.43||||||90.0|99.84|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.04|99.84|
91640117|NCT02129192|183171972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|100.33|||||TWO_SIDED|90.0|98.29|102.4|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.40|98.29|
91640118|NCT02129192|183171973|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|63.66||||1|TWO_SIDED|90.0|58.98|68.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||68.71|58.98|1.0000
91640119|NCT02129192|183171973|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.74|||<|0.0001|TWO_SIDED|90.0|97.08|102.48|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.48|97.08|<0.0001
91640120|NCT02129192|183171973|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.66||||0.0001|TWO_SIDED|90.0|85.8|93.7|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.70|85.80|0.0001
91673662|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0014|TWO_SIDED|95.0|1.26|2.67|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|1.26|0.0014
91673663|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0008|TWO_SIDED|95.0|1.33|2.99|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.99|1.33|0.0008
91673664|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0005|TWO_SIDED|95.0|1.37|3.06|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.37|0.0005
91673665|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0127|TWO_SIDED|95.0|1.16|3.49|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.16|0.0127
91673666|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0075|TWO_SIDED|95.0|1.22|3.64|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.64|1.22|0.0075
91673667|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0061|TWO_SIDED|95.0|1.17|2.52|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.17|0.0061
91673668|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0007|TWO_SIDED|95.0|1.33|2.88|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.88|1.33|0.0007
91673669|NCT02697773|183241312|SUPERIORITY|The two comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|1.89||||0.001|TWO_SIDED|95.0|1.29|2.76|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.29|0.0010
91673670|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0411|TWO_SIDED|95.0|1.02|2.31|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.02|0.0411
91673671|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.72||||0.009|TWO_SIDED|95.0|1.14|2.57|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.14|0.0090
91673672|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1149|TWO_SIDED|95.0|0.89|2.86|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|0.89|0.1149
91673673|NCT02697773|183241312|SUPERIORITY||Odds Ratio (OR)|1.56||||0.1351|TWO_SIDED|95.0|0.87|2.79|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|0.87|0.1351
91673674|NCT02697773|183241312|SUPERIORITY|The two comparisons for 'Participants with ≥50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.48|3.16|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.48|<.0001
91673675|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0001|TWO_SIDED|95.0|1.45|3.11|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.11|1.45|0.0001
91673676|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.59|3.4|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.59|<.0001
91673677|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0312|TWO_SIDED|95.0|1.04|2.39|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.04|0.0312
91716448|NCT00752089|183324442|SUPERIORITY_OR_OTHER||Adjusted mean difference|-321.438||||0.199|TWO_SIDED|95.0|-818.118|175.242||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||175.242|-818.118|0.1990
91716449|NCT00752089|183324442|SUPERIORITY_OR_OTHER||Adjusted mean difference|-72.68||||0.7718||95.0|-574.398|429.039||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||429.039|-574.398|0.7718
91716450|NCT00752089|183324442|SUPERIORITY_OR_OTHER||Adjusted mean difference|1784.675|||<|0.0001||95.0|1296.044|2273.306||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2273.306|1296.044|<0.0001
91716451|NCT00752089|183324442|SUPERIORITY_OR_OTHER||Adjusted mean difference|248.758||||0.3164||95.0|-245.962|743.478||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included tratment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||743.478|-245.962|0.3164
91716452|NCT00752089|183324442|SUPERIORITY_OR_OTHER||Adjusted mean difference|2106.113|||<|0.0001|TWO_SIDED|95.0|1620.906|2591.32||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2591.320|1620.906|<0.0001
91716453|NCT00752089|183324442|SUPERIORITY_OR_OTHER||Adjusted mean difference|1857.355|||<|0.0001|TWO_SIDED|95.0|1371.637|2343.072||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period and fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2343.072|1371.637|<0.0001
91716454|NCT01324102|183324443|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0||||The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.|ANOVA|F=10.25||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.||||.004
91716455|NCT01324102|183324443|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.|ANOVA|||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.||||.056
91793061|NCT05380180|183463855|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.||||<.05
91640121|NCT02129192|183171974|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|99.62|||||TWO_SIDED|90.0|96.32|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.04|96.32|
91673678|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0003|TWO_SIDED|95.0|1.4|3.19|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.19|1.40|0.0003
91673679|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0005|TWO_SIDED|95.0|1.48|4.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.01|1.48|0.0005
91716456|NCT00975416|183324452|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to deterimine whether oxytocin increased compared to placebo measures of therapeutic alliance (as measured by the Helping alliance questionnaire) pre compared to post 12 sessions of CBT.||||0.927
91716457|NCT00975416|183324452|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||Repeated measures anova to determine if oxytocin compared to placebo increased therpeutic alliance as measured by the working alliance inventory after 12 sessions of CBT.||||0.60
91716458|NCT00678418|183324550|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Van der Waerden|||Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.||||0.0002
91716459|NCT00678418|183324551|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.|Kaplan Meier|||P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.||||0.0042
91485596|NCT00932737|182844310|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0351|TWO_SIDED|95.0|-1.3|0.0|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.0|-1.3|0.0351
91673680|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0006|TWO_SIDED|95.0|1.45|3.94|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.94|1.45|0.0006
91673681|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0436|TWO_SIDED|95.0|1.02|4.32|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.32|1.02|0.0436
91673682|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1348|TWO_SIDED|95.0|0.84|3.69|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.69|0.84|0.1348
91673683|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.58|3.36|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.58|<.0001
91673684|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.46|3.09|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.46|<.0001
91673685|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.62|3.57|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.57|1.62|<.0001
91673686|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.74|3.82|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.74|<.0001
91673687|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.47|3.7|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.70|1.47|0.0003
91673688|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0001|TWO_SIDED|95.0|1.55|3.89|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.89|1.55|0.0001
91673689|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.02||||0.031|TWO_SIDED|95.0|1.07|3.82|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.07|0.0310
91673690|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0088|TWO_SIDED|95.0|1.24|4.34|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.34|1.24|0.0088
91673691|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.49||||0.036|TWO_SIDED|95.0|1.03|2.16|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.03|0.0360
91673692|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0039|TWO_SIDED|95.0|1.19|2.51|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.51|1.19|0.0039
91673693|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.13|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.13|1.43|0.0002
91673694|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.2|2.62|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.20|0.0040
91673695|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0175|TWO_SIDED|95.0|1.1|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|1.10|0.0175
91716460|NCT00678418|183324552|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||"P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.~Calculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method."||||<0.0001
91716461|NCT00678418|183324553|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.0154||95.0|0.6|0.95|||Chi-squared|||"Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.~Subjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result."||0.95|0.60|0.0154
91673696|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0065|TWO_SIDED|95.0|1.19|2.94|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.19|0.0065
91793062|NCT05380180|183463856|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.||||<.05
91640122|NCT02129192|183171974|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|101.21|||||TWO_SIDED|90.0|99.59|102.87|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||102.87|99.59|
91640123|NCT02129192|183171974|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|100.15|||||TWO_SIDED|90.0|98.23|102.1|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.10|98.23|
91640124|NCT02129192|183171975|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|64.4||||1|TWO_SIDED|90.0|59.59|69.59|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||69.59|59.59|1.0000
91640125|NCT02129192|183171975|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.45|||<|0.0001|TWO_SIDED|90.0|96.69|102.29|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.29|96.69|<0.0001
91640126|NCT02129192|183171975|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.82|||<|0.0001|TWO_SIDED|90.0|86.02|93.79|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.79|86.02|<0.0001
91640127|NCT00465894|183171981|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
91640128|NCT00129220|183172007|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.62|||<|0.001|TWO_SIDED|95.0|-8.87|-2.37|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-2.37|-8.87|<0.001
91640129|NCT00129220|183172008|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78||||0.774|TWO_SIDED|95.0|-6.15|4.59|||ANCOVA||Least Squares Mean Difference = Olazapine minus Haloperidol.|||4.59|-6.15|0.774
91673697|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0796|TWO_SIDED|95.0|0.94|3.23|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.94|0.0796
91673698|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0718|TWO_SIDED|95.0|0.95|3.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|0.95|0.0718
91716462|NCT00678418|183324554|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||van der Waerden|||Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.||||0.0031
91640130|NCT00129220|183172009|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|21.0||||0.064|TWO_SIDED|95.0|1.6|40.4|||Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||40.4|1.6|0.064
91716463|NCT06058390|183324571|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.14|0.91|
91640131|NCT00129220|183172010|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.21|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.21|-1.15|0.171
91640132|NCT00129220|183172011|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51||||0.006|TWO_SIDED|95.0|-0.87|-0.15||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.15|-0.87|0.006
91640133|NCT00129220|183172011|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.13||||0.722|TWO_SIDED|95.0|-0.82|0.57||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.57|-0.82|0.722
91673699|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0004|TWO_SIDED|95.0|1.36|2.96|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.36|0.0004
91673700|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.93|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.93|1.78|<.0001
91673701|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0001|TWO_SIDED|95.0|1.44|3.09|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.44|0.0001
91673702|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0002|TWO_SIDED|95.0|1.42|3.04|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.42|0.0002
91673703|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.41|3.23|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|1.41|0.0003
91716464|NCT06058390|183324572|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.96|1.15|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.15|0.96|
91673704|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.52|3.46|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.46|1.52|<.0001
91673705|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.09||||0.0113|TWO_SIDED|95.0|1.18|3.68|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.68|1.18|0.0113
91673706|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.19||||0.0064|TWO_SIDED|95.0|1.25|3.85|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.85|1.25|0.0064
91673707|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.58||||0.02|TWO_SIDED|95.0|1.07|2.31|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.07|0.0200
91673708|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.14|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.43|0.0002
91673709|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0005|TWO_SIDED|95.0|1.34|2.87|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.34|0.0005
91673710|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0141|TWO_SIDED|95.0|1.11|2.56|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.11|0.0141
91716465|NCT06058390|183324573|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.18|0.88|
91640134|NCT00129220|183172012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.333|TWO_SIDED|95.0|-6.7|20.1||P-value for 3-Week Response Rate.|Cochran-Mantel-Haenszel|||||20.1|-6.7|0.333
91640135|NCT00129220|183172012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.908|TWO_SIDED|95.0|-21.0|18.4||P-value for 6-Week Response Rate.|Cochran-Mantel-Haenszel|||||18.4|-21.0|0.908
91640136|NCT00129220|183172013|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9||||0.384|TWO_SIDED|95.0|-7.3|19.2||P-value for 3-Week Remission Rate.|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Placebo.|||19.2|-7.3|0.384
91640137|NCT00129220|183172013|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.982|TWO_SIDED|95.0|-21.3|21.8||P-value is for 6-Week Remission Rate|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||21.8|-21.3|0.982
91640138|NCT00129220|183172014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.698|TWO_SIDED|95.0|-3.2|4.9||P-value for 3-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||4.9|-3.2|0.698
91640139|NCT00129220|183172014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.014|TWO_SIDED|95.0|-31.7|3.4||P-value for 6-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||3.4|-31.7|0.014
91640140|NCT00129220|183172015|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48||||0.019|TWO_SIDED|95.0|-2.71|-0.25||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.25|-2.71|0.019
91640141|NCT00129220|183172015|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16||||0.855|TWO_SIDED|95.0|-1.95|1.62||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||1.62|-1.95|0.855
91640142|NCT00129220|183172016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.136|TWO_SIDED|95.0|-14.9|5.7||P-value for 6-Week Syndromic Depression Rate.|Cochran-Mantel-Haenszel|||||5.7|-14.9|0.136
91640143|NCT00129220|183172017|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Maximum Change from Baseline.|Wilcoxon Rank Sum|||||||0.003
91640144|NCT01883362|183172018|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2655|TWO_SIDED|95.0|0.12|1.86|||Log Rank|||||1.86|0.12|0.2655
91640145|NCT01883362|183172019|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
91640146|NCT01883362|183172020|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.2424|TWO_SIDED|95.0|0.2|1.52|||Log Rank|||||1.52|0.20|0.2424
91640147|NCT01883362|183172021|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
91640148|NCT01883362|183172022|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.3418|TWO_SIDED|95.0|0.19|1.79|||Log Rank|||||1.79|0.19|0.3418
91640149|NCT01883362|183172023|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.4169|TWO_SIDED|95.0|0.09|2.74|||Log Rank|||||2.74|0.09|0.4169
91640150|NCT00798161|183172136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.79|-0.36||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.36|-0.79|<0.0001
91640151|NCT00798161|183172136|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.3||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.30|-0.73|<0.0001
91640152|NCT00798161|183172136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.99|-0.55||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.55|-0.99|<0.0001
91527501|NCT04534114|182930302|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.95||||0.953|TWO_SIDED|95.0|0.19|4.72|||Log Rank|||||4.72|0.19|0.953
91640153|NCT00798161|183172136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.36|-0.92||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.92|-1.36|<0.0001
91640154|NCT00798161|183172137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.56|-0.26|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.26|-0.56|<0.0001
91640155|NCT00798161|183172137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.53|-0.23|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.23|-0.53|<0.0001
91640156|NCT00798161|183172137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.65|-0.35|||ANCOVA|||Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg||-0.35|-0.65|<0.0001
91640157|NCT00798161|183172137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.79|-0.48|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.48|-0.79|<0.0001
91640158|NCT00798161|183172138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.72|-0.31|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.31|-0.72|<0.0001
91640159|NCT00798161|183172138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.63|-0.22|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.22|-0.63|<0.0001
91640160|NCT00798161|183172138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.92|-0.51|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.51|-0.92|<0.0001
91640161|NCT00798161|183172138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.16|-0.75|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.75|-1.16|<0.0001
91640162|NCT00798161|183172139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.29|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.29|-0.73|<0.0001
91640163|NCT00798161|183172139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.69|-0.26|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.26|-0.69|<0.0001
91640164|NCT00798161|183172139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.94|-0.49|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.49|-0.94|<0.0001
91640165|NCT00798161|183172139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.3|-0.86|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.86|-1.30|<0.0001
91640166|NCT00798161|183172140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|5.0||0.0005||95.0|-27.2|-7.6|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-7.6|-27.2|0.0005
91640167|NCT00798161|183172140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|STANDARD_ERROR_OF_MEAN|5.0||0.0006||95.0|-27.1|-7.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.3|-27.1|0.0006
91640168|NCT00798161|183172140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-34.4|-14.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-14.8|-34.4|<0.0001
91640169|NCT00798161|183172140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-50.6|-31.0|||ANCOVA|||Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg||-31.0|-50.6|<0.0001
91673711|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.26|2.87|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.26|0.0022
91716466|NCT06058390|183324574|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.88|1.09|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.09|0.88|
91716467|NCT06058390|183324575|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.87|1.13|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.13|0.87|
91716468|NCT06058390|183324576|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.87|1.08|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.08|0.87|
91716469|NCT03292016|183324577|OTHER||Geometric Mean ratio (APL-130277/APOKYN)|12.3|||||TWO_SIDED|90.0|7.5|20.3|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||Sample size of 12 subjects, a two-sided 90% CI for the difference in paired PK parameter means on the log scale will have an interval that extends no more than 0.221 units from the observed difference with 90% coverage probability. Assumes CV of 35% for the difference on the original scale.||20.3|7.5|
91716470|NCT03292016|183324577|OTHER||Geometric Mean ratio (APL-130277/APO-go)|10.3|||||TWO_SIDED|90.0|6.5|16.3||||||||16.3|6.5|
91716471|NCT03292016|183324577|OTHER|relative bioavailibilty|Geometric Mean ratio (APOKYN/APO-go)|83.4|||||TWO_SIDED|90.0|50.5|137.6||||||||137.6|50.5|
91716472|NCT03292016|183324577|OTHER||Ratio|0.21|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
91716473|NCT03292016|183324577|OTHER||Ratio|0.13|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
91793063|NCT05380180|183463857|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||We implemented an intent-to-treat analysis, including all participants who were randomized in the analysis, regardless of their participation status. To analyze the main effects of the intervention, we conducted linear mixed-effects model. Fixed factors included time of assessment (baseline/Week 4/Week 8) and group (intervention/waitlist control). Participant was included as a random intercept to account for individual variability at baseline.||||<.05
91673712|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2286|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|0.80|0.2286
91716474|NCT03292016|183324577|OTHER||Ratio|1.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
91716475|NCT03292016|183324577|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
91716476|NCT03292016|183324577|OTHER||Ratio|0.17|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
91716477|NCT03292016|183324577|OTHER||Ratio|1.12|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
91716478|NCT03292016|183324577|OTHER||Ratio|0.08|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
91716479|NCT03292016|183324577|OTHER||Ratio|0.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
91716480|NCT03292016|183324577|OTHER||Ratio|1.04|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
91716481|NCT03292016|183324578|OTHER|||||||0.0625|||||||Sign test|||||||0.0625
91716482|NCT03292016|183324578|OTHER|||||||0.0313|||||||Sign test|||||||0.0313
91716483|NCT03292016|183324578|OTHER||||||>|0.9999|||||||Sign test|||||||>0.9999
91716484|NCT03292016|183324579|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.2|||||TWO_SIDED|90.0|13.1|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.1|
91716485|NCT03292016|183324579|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|16.7|||||TWO_SIDED|90.0|13.0|21.3|||Mixed Models Analysis|||||21.3|13.0|
91716486|NCT03292016|183324579|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|96.9|||||TWO_SIDED|90.0|74.2|126.4||||||||126.4|74.2|
91716487|NCT03292016|183324579|OTHER||Ratio|0.32|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
91716488|NCT03292016|183324579|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
91716489|NCT03292016|183324579|OTHER||Ratio|1.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
91716490|NCT03292016|183324579|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
91716491|NCT03292016|183324579|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
91716492|NCT03292016|183324579|OTHER||Ratio|1.0|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
91716493|NCT03292016|183324579|OTHER||Ratio|0.15|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
91716494|NCT03292016|183324579|OTHER||Ratio|0.14|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
91673713|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|1.47||||0.1808|TWO_SIDED|95.0|0.84|2.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|0.84|0.1808
91793064|NCT04831216|183463861|OTHER|||||||0.0107||||||The p-value reflects results of analysis of change in HbA1c from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0107
91640170|NCT00798161|183172141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|4.1||0.0003||95.0|-22.9|-6.8|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-6.8|-22.9|0.0003
91640171|NCT00798161|183172141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-24.9|-8.8|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.8|-24.9|<0.0001
91640172|NCT00798161|183172141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-29.5|-13.4|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-13.4|-29.5|<0.0001
91640173|NCT00798161|183172141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-33.6|-17.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-17.6|-33.6|<0.0001
91640174|NCT00798161|183172142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-26.7|-9.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-9.1|-26.7|<0.0001
91640175|NCT00798161|183172142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.5||0.0002||95.0|-25.6|-7.9|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.9|-25.6|0.0002
91640176|NCT00798161|183172142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-36.7|-19.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-19.1|-36.7|<0.0001
91640177|NCT00798161|183172142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-46.4|-28.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.8|-46.4|<0.0001
91640178|NCT00798161|183172143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|4.7||0.0024||95.0|-23.7|-5.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-5.1|-23.7|0.0024
91640179|NCT00798161|183172143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0|STANDARD_ERROR_OF_MEAN|4.8||0.0002||95.0|-27.4|-8.7|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.7|-27.4|0.0002
91640180|NCT00798161|183172143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-37.1|-18.5|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-18.5|-37.1|<0.0001
91640181|NCT00798161|183172143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-50.8|-32.2|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-32.2|-50.8|<0.0001
91640182|NCT00798161|183172144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.4|-11.4|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-11.4|-30.4|<0.0001
91640183|NCT00798161|183172144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.9||0.0003||95.0|-27.4|-8.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.3|-27.4|0.0003
91640184|NCT00798161|183172144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-35.0|-15.9|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-15.9|-35.0|<0.0001
91640185|NCT00798161|183172144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-48.5|-29.4|||ANCOVA|||Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg||-29.4|-48.5|<0.0001
91673714|NCT02697773|183241314|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.57|3.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.57|<.0001
91640186|NCT00798161|183172145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.0062||95.0|1.278|4.402|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||4.402|1.278|0.0062
91640187|NCT00798161|183172145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.163|||<|0.0001||95.0|2.343|7.397|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.397|2.343|<0.0001
91640188|NCT00798161|183172145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.854|||<|0.0001||95.0|2.363|9.973|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||9.973|2.363|<0.0001
91640189|NCT00798161|183172145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.094|||<|0.0001||95.0|8.238|35.471|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||35.471|8.238|<0.0001
91640190|NCT00798161|183172147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.465||||0.0102||95.0|1.342|8.943|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||8.943|1.342|0.0102
91640191|NCT00798161|183172147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.521||||0.0004||95.0|1.747|7.094|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.094|1.747|0.0004
91640192|NCT00798161|183172147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.521||||0.0053||95.0|1.564|13.069|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||13.069|1.564|0.0053
91485597|NCT00932737|182844311|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3557|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide and Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.4|-1.0|0.3557
91640193|NCT00798161|183172147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.947|||<|0.0001||95.0|4.314|33.08|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||33.080|4.314|<0.0001
91640194|NCT00798161|183172149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.181|||<|0.0001||95.0|1.903|5.316|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||5.316|1.903|<0.0001
91640195|NCT00798161|183172149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.382||||0.0027||95.0|1.352|4.196|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||4.196|1.352|0.0027
91716495|NCT03292016|183324579|OTHER||Ratio|0.96|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
91640196|NCT00798161|183172149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.622|||<|0.0001||95.0|2.153|6.093|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||6.093|2.153|<0.0001
91640197|NCT00798161|183172149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.529|||<|0.0001||95.0|3.724|11.445|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||11.445|3.724|<0.0001
91640198|NCT00798161|183172150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|22.7||0.8893||95.0|-48.5|42.2|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||42.2|-48.5|0.8893
91640199|NCT00798161|183172150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|STANDARD_ERROR_OF_MEAN|22.1||0.3234||95.0|-66.2|22.2|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||22.2|-66.2|0.3234
91640200|NCT00798161|183172150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.8|STANDARD_ERROR_OF_MEAN|23.8||0.0373||95.0|-98.5|-3.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-3.1|-98.5|0.0373
91640201|NCT00798161|183172150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-73.9|STANDARD_ERROR_OF_MEAN|22.7||0.0018||95.0|-119.3|-28.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.6|-119.3|0.0018
91640202|NCT00798161|183172153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.326||||0.0445|TWO_SIDED|95.0|0.109|0.973|||Regression, Logistic|||||0.973|0.109|0.0445
91640203|NCT00798161|183172153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.274||||0.0151|TWO_SIDED|95.0|0.096|0.779|||Regression, Logistic|||||0.779|0.096|0.0151
91673715|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.44||||0.1463|TWO_SIDED|95.0|0.88|2.34|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.34|0.88|0.1463
91673716|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9644|TWO_SIDED|95.0|0.6|1.62|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.62|0.60|0.9644
91485598|NCT00932737|182844312|OTHER||Odds Ratio (OR)|1.071||||0.831|TWO_SIDED|95.0|0.572|2.004|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.004|0.572|0.831
91485599|NCT00932737|182844313|OTHER||Odds Ratio (OR)|1.222||||0.557|TWO_SIDED|95.0|0.626|2.387|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.387|0.626|0.557
91640204|NCT00798161|183172153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.049|TWO_SIDED|95.0|0.177|0.996|||Regression, Logistic|||||0.996|0.177|0.0490
91640205|NCT00798161|183172153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.598||||0.2617|TWO_SIDED|95.0|0.244|1.467|||Regression, Logistic|||||1.467|0.244|0.2617
91640206|NCT00594568|183172154|SUPERIORITY_OR_OTHER|||||||0.134||95.0|||||Mixed Models Analysis|||||||0.134
91640207|NCT00594568|183172154|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||||||0.045
91640208|NCT00594568|183172154|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Mixed Models Analysis|||||||0.610
91640209|NCT00594568|183172155|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Mixed Models Analysis|||||||0.296
91640210|NCT00594568|183172155|SUPERIORITY_OR_OTHER|||||||0.172||95.0|||||Mixed Models Analysis|||||||0.172
91640211|NCT00594568|183172155|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Mixed Models Analysis|||||||0.746
91640212|NCT00594568|183172156|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Mixed Models Analysis|||||||0.166
91640213|NCT00594568|183172156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91640214|NCT00594568|183172156|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Models Analysis|||||||0.014
91640215|NCT00594568|183172157|SUPERIORITY_OR_OTHER|||||||0.935||95.0|||||Mixed Models Analysis|||||||0.935
91673717|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0422|TWO_SIDED|95.0|1.02|2.59|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.02|0.0422
91716496|NCT03292016|183324580|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.6|||||TWO_SIDED|90.0|13.7|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.7|
91673718|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1995|TWO_SIDED|95.0|0.85|2.16|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|0.85|0.1995
91673719|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4878|TWO_SIDED|95.0|0.75|1.84|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.84|0.75|0.4878
91673720|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7856|TWO_SIDED|95.0|0.68|1.67|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.67|0.68|0.7856
91673721|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0476|TWO_SIDED|95.0|1.0|2.39|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.00|0.0476
91673722|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0124|TWO_SIDED|95.0|1.12|2.63|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.12|0.0124
91673723|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.66||||0.0307|TWO_SIDED|95.0|1.05|2.62|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.05|0.0307
91673724|NCT02697773|183241316|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0846|TWO_SIDED|95.0|0.95|2.35|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|0.95|0.0846
91716497|NCT03292016|183324580|OTHER||Geometric Mean Ratio (APL-130277/APO-go)|17.2|||||TWO_SIDED|90.0|13.7|21.6|||Mixed Models Analysis|||||21.6|13.7|
91673725|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0319|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.03|-0.63|0.0319
91673726|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.68|-0.08|||ANCOVA|||Week 1:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.08|-0.68|0.0139
91673727|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0011|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.25|-1.03|0.0011
91673728|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0053|TWO_SIDED|95.0|-0.93|-0.16|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.16|-0.93|0.0053
91716498|NCT03292016|183324580|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|97.8|||||TWO_SIDED|90.0|76.6|124.8|||Mixed Models Analysis|||||124.8|76.6|
91716499|NCT03292016|183324585|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
91716500|NCT03292016|183324585|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
91640216|NCT00594568|183172157|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Mixed Models Analysis|||||||0.068
91640217|NCT00594568|183172157|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||||||0.070
91640218|NCT00594568|183172158|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
91640219|NCT00594568|183172158|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91640220|NCT00594568|183172158|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91640221|NCT00594568|183172159|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||0.038
91640222|NCT00594568|183172159|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANCOVA|||||||0.147
91640223|NCT00594568|183172159|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
91640224|NCT00594568|183172160|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.143
91716501|NCT03292016|183324585|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||||||>0.9999
91716502|NCT01211145|183324662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.312|TWO_SIDED|95.0|0.75|2.5||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.50|0.75|.312
91716503|NCT01211145|183324662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.071|TWO_SIDED|95.0|0.95|3.26||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.26|0.95|.071
91716504|NCT01211145|183324662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.4|3.39||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||3.39|1.40|<.001
91716505|NCT01211145|183324663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.575|TWO_SIDED|95.0|0.7|1.91||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.91|0.70|.575
91716506|NCT01211145|183324663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.032|TWO_SIDED|95.0|1.06|3.31||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.31|1.06|.032
91716507|NCT01211145|183324663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.137|TWO_SIDED|95.0|0.91|1.95||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||1.95|0.91|.137
91716508|NCT01211145|183324664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.458|TWO_SIDED|95.0|0.74|1.96||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.96|0.74|.458
91716509|NCT01211145|183324664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.021|TWO_SIDED|95.0|1.09|3.03||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.03|1.09|.021
91716510|NCT01211145|183324664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.12|2.32||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.32|1.12|.010
91716511|NCT01211145|183324665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.753|TWO_SIDED|95.0|0.64|1.84||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.84|0.64|.753
91716512|NCT01211145|183324665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.145|TWO_SIDED|95.0|0.86|2.79||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.79|0.86|.145
91716513|NCT01211145|183324665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.127|TWO_SIDED|95.0|0.91|2.04||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.04|0.91|.127
91716514|NCT01211145|183324666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.274|TWO_SIDED|95.0|0.79|2.32||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.32|0.79|.274
91716515|NCT01211145|183324666|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.67||||0.067|TWO_SIDED|95.0|0.96|2.91||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.91|0.96|.067
91485600|NCT00932737|182844314|OTHER||Odds Ratio (OR)|0.737||||0.396|TWO_SIDED|95.0|0.365|1.49|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||1.490|0.365|0.396
91716516|NCT01211145|183324666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.127|TWO_SIDED|95.0|0.91|2.08||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.08|0.91|.127
91716517|NCT01211145|183324667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.153|TWO_SIDED|95.0|0.38|1.16||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.16|0.38|.153
91716518|NCT01211145|183324667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.087|TWO_SIDED|95.0|0.33|1.08||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||1.08|0.33|.087
91716519|NCT01211145|183324667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.36|0.83||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||0.83|0.36|.004
91716520|NCT04195061|183324668|SUPERIORITY|||||||0.303|||||||t-test, 2 sided|||||||0.303
91716521|NCT04195061|183324669|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91716522|NCT04195061|183324670|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91640225|NCT00594568|183172160|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.464
91640226|NCT00594568|183172160|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.025
91640227|NCT00594568|183172160|SUPERIORITY_OR_OTHER|||||||0.347||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.347
91640228|NCT00594568|183172160|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.820
91640229|NCT00594568|183172160|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.243
91640230|NCT00594568|183172161|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANCOVA|||||||0.784
91640231|NCT00594568|183172161|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||ANCOVA|||||||0.931
91640232|NCT00594568|183172161|SUPERIORITY_OR_OTHER|||||||0.718||95.0|||||ANCOVA|||||||0.718
91640233|NCT00594568|183172162|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANCOVA|||||||0.634
91640234|NCT00594568|183172162|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|||||||0.901
91640235|NCT00594568|183172162|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||ANCOVA|||||||0.659
91640236|NCT00594568|183172165|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Mixed Models Analysis|||||||0.062
91640237|NCT00594568|183172165|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||||||0.022
91640238|NCT00594568|183172165|SUPERIORITY_OR_OTHER|||||||0.669||95.0|||||Mixed Models Analysis|||||||0.669
91640239|NCT00594568|183172166|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Mixed Models Analysis|||||||0.071
91640240|NCT00594568|183172166|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
91640241|NCT00594568|183172166|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Mixed Models Analysis|||||||0.571
91640242|NCT00594568|183172167|SUPERIORITY_OR_OTHER|||||||0.518||95.0|||||Mixed Models Analysis|||||||0.518
91640243|NCT00594568|183172167|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Mixed Models Analysis|||||||0.013
91640244|NCT00594568|183172167|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Mixed Models Analysis|||||||0.072
91640245|NCT00594568|183172168|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Mixed Models Analysis|||||||0.069
91640246|NCT00594568|183172168|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||||||0.002
91640247|NCT00594568|183172168|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Mixed Models Analysis|||||||0.198
91640248|NCT00594568|183172169|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Mixed Models Analysis|||||||0.127
91640249|NCT00594568|183172169|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Mixed Models Analysis|||||||0.016
91640250|NCT00594568|183172169|SUPERIORITY_OR_OTHER|||||||0.381||95.0|||||Mixed Models Analysis|||||||0.381
91640251|NCT00594568|183172170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91640252|NCT00594568|183172170|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||||||0.005
91640253|NCT00594568|183172170|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Mixed Models Analysis|||||||0.141
91640254|NCT00594568|183172171|SUPERIORITY_OR_OTHER|||||||0.337||95.0|||||ANCOVA|||||||0.337
91640255|NCT00594568|183172171|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
91640256|NCT00594568|183172171|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||ANCOVA|||||||0.157
91640257|NCT00594568|183172172|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Mixed Models Analysis|||||||0.186
91640258|NCT00594568|183172172|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Mixed Models Analysis|||||||0.149
91640259|NCT00594568|183172172|SUPERIORITY_OR_OTHER|||||||0.889||95.0|||||Mixed Models Analysis|||||||0.889
91640260|NCT00594568|183172173|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Mixed Models Analysis|||||||0.202
91716523|NCT02688933|183324690|SUPERIORITY||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|1.15||0.8494|TWO_SIDED|||||Threshold for significance at 0.05 level.|Generalized linear model|Generalized linear model with identity link||Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening \[\<8.0% vs ≥8.0%\], frequency of Lantus injection at screening, current CGM use \[yes/no\], and mealtime insulin titration algorithm).||||0.8494
91716524|NCT04379921|183324794|OTHER|||||||0.26801155||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to SF-36||||0.26801155
91716525|NCT04379921|183324794|OTHER|||||||0.27520264||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to EQ-5D||||0.27520264
91716526|NCT04379921|183324794|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to PROMIS||||0.95547874
91716527|NCT04379921|183324794|OTHER|||||||0.5623012||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to NDI||||0.56230120
91716528|NCT04379921|183324794|OTHER|||||||0.3581397||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to ODI||||0.35813970
91640261|NCT00594568|183172173|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Mixed Models Analysis|||||||0.075
91640262|NCT00594568|183172173|SUPERIORITY_OR_OTHER|||||||0.616||95.0|||||Mixed Models Analysis|||||||0.616
91640263|NCT01366846|183172191|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
91640264|NCT01366846|183172191|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.004
91640265|NCT01366846|183172192|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of participants with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
91640266|NCT01366846|183172193|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
91640267|NCT01366846|183172193|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.027
91640268|NCT01366846|183172194|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
91640269|NCT01366846|183172195|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
91640270|NCT01366846|183172196|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
91640271|NCT04311411|183172204|SUPERIORITY||Median Difference (Final Values)|-534.11|||<|0.0001|TWO_SIDED|95.0|-668.2|-400.02|||ANCOVA|||||-400.02|-668.20|<.0001
91640272|NCT04311411|183172205|SUPERIORITY||Median Difference (Final Values)|0.0439||||0.5437|TWO_SIDED|95.0|-0.0994|0.1871|||Mixed Models Analysis|||Insula||0.1871|-0.0994|0.5437
91640273|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.1806|TWO_SIDED|95.0|-0.0441|0.2301|||Mixed Models Analysis|||Insula||0.2301|-0.0441|0.1806
91640274|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0491||||0.472|TWO_SIDED|95.0|-0.1846|0.0863|||Mixed Models Analysis|||Insula||0.0863|-0.1846|0.4720
91640275|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9842|TWO_SIDED|95.0|-0.1079|0.1058|||Mixed Models Analysis|||Medial frontal gyrus||0.1058|-0.1079|0.9842
91640276|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|0.0077||||0.8822|TWO_SIDED|95.0|-0.0949|0.1102|||Mixed Models Analysis|||Medial frontal gyrus||0.1102|-0.0949|0.8822
91640277|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0087||||0.8657|TWO_SIDED|95.0|-0.1111|0.0937|||Mixed Models Analysis|||Medial frontal gyrus||0.0937|-0.1111|0.8657
91640278|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|0.0043||||0.9599|TWO_SIDED|95.0|-0.165|0.1736|||Mixed Models Analysis|||Superior temporal gyrus||0.1736|-0.1650|0.9599
91640279|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|0.0489||||0.549|TWO_SIDED|95.0|-0.1129|0.2107|||Mixed Models Analysis|||Superior temporal gyrus||0.2107|-0.1129|0.5490
91640280|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0446||||0.5854|TWO_SIDED|95.0|-0.2068|0.1176|||Mixed Models Analysis|||Superior temporal gyrus||0.1176|-0.2068|0.5854
91640281|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0192||||0.7203|TWO_SIDED|95.0|-0.1259|0.0874|||Mixed Models Analysis|||Precentral gyrus||0.0874|-0.1259|0.7203
91640282|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|0.0404||||0.433|TWO_SIDED|95.0|-0.0617|0.1425|||Mixed Models Analysis|||Precentral gyrus||0.1425|-0.0617|0.4330
91640283|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0596||||0.2488|TWO_SIDED|95.0|-0.1619|0.0426|||Mixed Models Analysis|||Precentral gyrus||0.0426|-0.1619|0.2488
91640284|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.8886|TWO_SIDED|95.0|-0.1059|0.0919|||Mixed Models Analysis|||Cingulate gyrus||0.0919|-0.1059|0.8886
91640285|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|0.0684||||0.1563|TWO_SIDED|95.0|-0.0267|0.1635|||Mixed Models Analysis|||Cingulate gyrus||0.1635|-0.0267|0.1563
91640286|NCT04311411|183172205|SUPERIORITY||Mean Difference (Final Values)|-0.0754||||0.1182|TWO_SIDED|95.0|-0.1704|0.0196|||Mixed Models Analysis|||Cingulate gyrus||0.0196|-0.1704|0.1182
91640287|NCT04311411|183172206|SUPERIORITY||Mean Difference (Final Values)|20.57|||<|0.0001|TWO_SIDED|95.0|12.11|29.02|||Mixed Models Analysis|||Fasting (Pre-lunch)||29.02|12.11|<.0001
91640288|NCT04311411|183172206|SUPERIORITY||Mean Difference (Final Values)|6.63||||0.1097|TWO_SIDED|95.0|-1.53|14.79||Fasting|Mixed Models Analysis|||Fasting (Pre-lunch)||14.79|-1.53|0.1097
91640289|NCT04311411|183172206|SUPERIORITY||Mean Difference (Final Values)|13.94||||0.0015|TWO_SIDED|95.0|5.49|22.38|||Mixed Models Analysis|||Fasting (Pre-lunch)||22.38|5.49|0.0015
91640290|NCT04311411|183172206|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.4469|TWO_SIDED|95.0|-3.6|8.09|||Mixed Models Analysis|||Postprandial (Post-lunch)||8.09|-3.60|0.4469
91640291|NCT04311411|183172206|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.8227|TWO_SIDED|95.0|-5.02|6.31|||Mixed Models Analysis|||Postprandial (Post-lunch)||6.31|-5.02|0.8227
91640292|NCT04311411|183172206|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.5861|TWO_SIDED|95.0|-4.23|7.45|||Mixed Models Analysis|||Postprandial (Post-lunch)||7.45|-4.23|0.5861
91640293|NCT00933543|183172291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0703|TWO_SIDED|95.0|0.65|63.18||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||63.18|0.65|0.0703
91640294|NCT00933543|183172293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.92||||0.2969|TWO_SIDED|95.0|-11.35|3.5||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||3.50|-11.35|0.2969
91640295|NCT00933543|183172294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.8913|TWO_SIDED|95.0|-9.09|10.43||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||10.43|-9.09|0.8913
91640296|NCT00694070|183172317|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%."||||||0.0421|||||||Exact binomial test|||||||0.0421
91640297|NCT00694070|183172318|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%."||||||0.0309|||||||Exact binomial test|||||||0.0309
91640298|NCT00694070|183172319|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%."||||||0.0309|||||||Exact binomial test|||||||0.0309
91673729|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.08|0.0014
91673730|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.17|-0.36|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.36|-1.17|0.0002
91673731|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.49|-1.33|<.0001
91640299|NCT04988035|183172323|SUPERIORITY||Odds Ratio (OR)|0.64||||0.09|TWO_SIDED|95.0|0.38|1.07|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.07|0.38|0.090
91640300|NCT04988035|183172324|SUPERIORITY||Odds Ratio (OR)|0.69||||0.358|TWO_SIDED|95.0|0.31|1.53|||Regression, Logistic|||Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).|Odds ratio greater than 1 favors Remdesivir plus Danicopan|1.53|0.31|0.358
91640301|NCT04988035|183172325|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.014|TWO_SIDED|95.0|0.46|0.92|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||0.92|0.46|0.014
91793065|NCT04831216|183463862|OTHER|||||||0.7927||||||The p-value reflects results of analysis of change in skin carotenoid levels from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.7927
91793066|NCT04831216|183463863|OTHER|||||||0.4651||||||The p-value reflects results of analysis of change in HEI score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.4651
91793067|NCT04831216|183463864|OTHER|||||||0.2439||||||The p-value reflects results of analysis of change in BMI from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2439
91485601|NCT00932737|182844315|OTHER||Odds Ratio (OR)|1.336||||0.448|TWO_SIDED|95.0|0.632|2.827|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.827|0.632|0.448
91673732|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.52|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.52|-1.36|<.0001
91673733|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0015|TWO_SIDED|95.0|-1.16|-0.28|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.28|-1.16|0.0015
91673734|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.12|0.0023
91673735|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0512|TWO_SIDED|95.0|-0.89|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.00|-0.89|0.0512
91673736|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0693|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0693
91673737|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.0043|TWO_SIDED|95.0|-1.14|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.14|0.0043
91673738|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.13|0.0041
91673739|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0024|TWO_SIDED|95.0|-1.19|-0.26|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.19|0.0024
91673740|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.24||0.0015|TWO_SIDED|95.0|-1.22|-0.29|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.29|-1.22|0.0015
91673741|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.25||0.0063|TWO_SIDED|95.0|-1.16|-0.19|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.19|-1.16|0.0063
91485602|NCT00932737|182844316|OTHER||Odds Ratio (OR)|2.474||||0.03|TWO_SIDED|95.0|1.093|5.604|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||5.604|1.093|0.030
91485603|NCT00932737|182844317|OTHER||Odds Ratio (OR)|1.654||||0.167|TWO_SIDED|95.0|0.81|3.378|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||3.378|0.810|0.167
91640302|NCT04988035|183172326|SUPERIORITY||Odds Ratio (OR)|0.7||||0.177|TWO_SIDED|95.0|0.42|1.17|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.17|0.42|0.177
91640303|NCT04988035|183172327|SUPERIORITY||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.36|||Proportional odds model|||Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 29 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 29 after discharge are given a score of 2.|Odds ratio above 1 favors Remdesivir plus Danicopan.|1.36|0.48|0.427
91640304|NCT04988035|183172362|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.109|TWO_SIDED|95.0|0.56|1.06|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|||1.06|0.56|0.109
91640305|NCT04988035|183172363|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.036|TWO_SIDED|95.0|0.51|0.98|||Regression, Cox||||HR greater than 1 favors Remdesivir plus Danicopan.|0.98|0.51|0.036
91640306|NCT01828164|183172405|SUPERIORITY_OR_OTHER||Percent Change|29.0||||0.0164|TWO_SIDED||||||t-test, 1 sided||Percent change in tooth movement rate on the treatment side as compared to the control side.|||||0.0164
91640307|NCT01828164|183172406|SUPERIORITY_OR_OTHER||Percent change|220.8||||0.0423|TWO_SIDED||||||t-test, 1 sided||Percent change in root resorption rate on the control side as compared to the treatment side.|||||0.0423
91640308|NCT01828164|183172407|NON_INFERIORITY|1 point on the 10-point pain scale was used as the non-inferiority margin.|||||<|0.001|||||||Bootstrapped mean difference|This test bootstrapped the mean difference (Treatment Arm - Control Arm) less 1, the non-inferiority margin, 1000 times.||||||<0.001
91640309|NCT00635362|183172453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||||||0.35
91640310|NCT00635362|183172454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
91640311|NCT00635362|183172455|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|0.0|||||Fisher Exact|||||||1.000
91640312|NCT00635362|183172456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|0.0|||||Fisher Exact|||||||0.37
91640313|NCT00635362|183172457|SUPERIORITY_OR_OTHER_LEGACY|||||||1||0.0|||||Fisher Exact|||||||1.00
91640314|NCT00620191|183172462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|1.92||0.05|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
91640315|NCT00620191|183172462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.1|STANDARD_DEVIATION|1.36||0.05|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog value|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
91640316|NCT00620191|183172463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98|STANDARD_DEVIATION|1.01||0.06|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.06
91640317|NCT00620191|183172463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|0.91||0.34|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog score.|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
91640318|NCT00620191|183172464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.14||0.36|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.36
91640319|NCT00620191|183172465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|4.73||0.34|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
91640320|NCT00674440|183172475|OTHER||Sensitivity|93.0|||||TWO_SIDED|95.0|80.9|98.5||||||||98.5|80.9|
91640321|NCT00674440|183172475|OTHER||Specifity|88.5|||||TWO_SIDED|95.0|76.6|95.6||||||||95.6|76.6|
91640322|NCT00863265|183172502|EQUIVALENCE||Mean Difference (Final Values)|289.0||||0.01|TWO_SIDED||||||ANOVA||The estimation parameter is the difference between the placebo group and the ezetimibe group.|Phytosterol Diet compared to Ezetimibe||||0.01
91640323|NCT00863265|183172502|EQUIVALENCE|The hypothesis is that groups are equal.|Mean Difference (Final Values)|457.0|||<|0.01|TWO_SIDED||||||ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
91640324|NCT00863265|183172502|EQUIVALENCE|The hypothesis is that groups are equal|Mean Difference (Final Values)|168.0|||<|0.01|TWO_SIDED||||||ANOVA|||Ezetimibe vs. Ezetimibe Plus Phytosterols||||<0.01
91640325|NCT00863265|183172503|EQUIVALENCE|Not applicable in this study.|Mean Difference (Final Values)|22.8|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal||||<0.01
91640326|NCT00863265|183172503|EQUIVALENCE||Mean Difference (Final Values)|36.4|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
91640327|NCT00863265|183172503|EQUIVALENCE||Mean Difference (Final Values)|13.6|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.01
91640328|NCT00863265|183172504|EQUIVALENCE||Mean Difference (Final Values)|21.0|||<|0.01|TWO_SIDED||||||ANOVA|||The hypothesis is that groups are equal.||||<0.01
91640329|NCT00863265|183172504|EQUIVALENCE||Mean Difference (Final Values)|28.0|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that all groups are equal||||<0.01
91640330|NCT00863265|183172504|EQUIVALENCE||Mean Difference (Final Values)|7.0|||<|0.05|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.05
91640331|NCT05510297|183172509|SUPERIORITY||Median Difference (Net)|7.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
91640332|NCT05510297|183172510|SUPERIORITY||Mean Difference (Final Values)|2653.16|STANDARD_DEVIATION|5110.86||0.074|TWO_SIDED|95.0|-297.76522|5604.07522||a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made; data were checked for normality using the Shapiro-Wilk test where p\>0.05 was interpreted as likely normal distribution.|t-test, 2 sided|||||5604.07522|-297.76522|0.074
91485604|NCT00932737|182844318|OTHER|||||||0.256|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.2560
91673742|NCT02697773|183241317|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.24||0.0008|TWO_SIDED|95.0|-1.3|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.30|0.0008
91673743|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.61|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.61|-1.47|<.0001
91673744|NCT02697773|183241319|SUPERIORITY||Least Mean Square Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.62|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.62|-1.47|<.0001
91673745|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.67|-0.81|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.81|-1.67|<.0001
91673746|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.80|-1.66|<.0001
91673747|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.0007|TWO_SIDED|95.0|-1.25|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.25|0.0007
91673748|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.23||0.0013|TWO_SIDED|95.0|-1.2|-0.29|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.20|0.0013
91716529|NCT04379921|183324794|OTHER|||||||0.26801155||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to SF-36||||0.26801155
91485605|NCT00932737|182844319|OTHER|||||||0.5179|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.5179
91673749|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.51|-0.55|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.51|<.0001
91673750|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.67|-0.73|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.73|-1.67|<.0001
91673751|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.25||0.0007|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0007
91673752|NCT02697773|183241319|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.48|-0.51|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.48|<.0001
91673753|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.22|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.22|<.0001
91716530|NCT04379921|183324794|OTHER|||||||0.08121447||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to EQ-5D||||0.08121447
91673754|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.29|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.29|<.0001
91640333|NCT05510297|183172511|SUPERIORITY|a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made;|Mean Difference (Net)|4.44067|STANDARD_DEVIATION|41.59009||0.685|TWO_SIDED|95.0|-18.59116|27.47249|||t-test, 2 sided|||||27.47249|-18.59116|0.685
91640334|NCT05510297|183172512|SUPERIORITY||Mean Difference (Net)|-0.51267|STANDARD_DEVIATION|1.44656||0.191|TWO_SIDED|95.0|-1.31374|0.28841|||t-test, 2 sided|||||0.28841|-1.31374|0.191
91640335|NCT05510297|183172513|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_DEVIATION|1.35026||0.218|TWO_SIDED|95.0|-1.19775|0.29775|||t-test, 2 sided|||||0.29775|-1.19775|0.218
91640336|NCT05510297|183172514|SUPERIORITY||Mean Difference (Net)|-0.924|STANDARD_DEVIATION|2.19396||0.125|TWO_SIDED|95.0|-2.13898|0.29098|||t-test, 2 sided|||||0.29098|-2.13898|0.125
91640337|NCT05510297|183172515|SUPERIORITY||Mean Difference (Net)|0.00133|STANDARD_DEVIATION|0.10148||0.96|TWO_SIDED|95.0|-0.05486|0.5753|||t-test, 2 sided|||||0.5753|-0.05486|0.960
91640338|NCT05510297|183172519|SUPERIORITY||Mean Difference (Net)|-0.622|STANDARD_DEVIATION|1.6553||0.168|TWO_SIDED|95.0|-1.53867|0.29467|||t-test, 2 sided|||||0.29467|-1.53867|0.168
91640339|NCT04409262|183172520|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.7414|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7414
91640340|NCT04409262|183172521|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8993|TWO_SIDED|95.0|0.72|1.34|||Log Rank|||||1.34|0.72|0.8993
91640341|NCT04409262|183172522|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7648|TWO_SIDED|95.0|0.77|1.44|||Regression, Logistic|||||1.44|0.77|0.7648
91640342|NCT04409262|183172523|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7867|TWO_SIDED|95.0|0.65|1.39|||Log Rank|||||1.39|0.65|0.7867
91640343|NCT04409262|183172524|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.4602|TWO_SIDED|95.0|0.63|1.23|||Log Rank|||||1.23|0.63|0.4602
91640344|NCT04409262|183172525|SUPERIORITY||Hazard Ratio (HR)|0.982||||0.8664|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||||1.21|0.80|0.8664
91640345|NCT04409262|183172526|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9569|TWO_SIDED|95.0|0.75|1.35|||Regression, Logistic|||||1.35|0.75|0.9569
91640346|NCT04409262|183172527|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6331|TWO_SIDED|95.0|0.78|1.52|||Regression, Logistic|||||1.52|0.78|0.6331
91640347|NCT04409262|183172528|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9622|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|||||1.40|0.70|0.9622
91640348|NCT04409262|183172529|SUPERIORITY||Odds Ratio (OR)|1.14||||0.485|TWO_SIDED|95.0|0.79|1.64|||Regression, Logistic|||||1.64|0.79|0.4850
91640349|NCT04409262|183172530|SUPERIORITY||Weighted % difference|-2.2||||0.5915|TWO_SIDED|95.0|-10.2|5.9|||Cochran-Mantel-Haenszel|||Day 28||5.9|-10.2|0.5915
91716531|NCT04379921|183324794|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to PROMIS||||0.95547874
91640350|NCT04409262|183172530|SUPERIORITY||Weighted % difference|-2.5||||0.5494|TWO_SIDED|95.0|-10.5|5.6|||Cochran-Mantel-Haenszel|||Day 60||5.6|-10.5|0.5494
91640351|NCT04409262|183172531|SUPERIORITY||Weighted % difference|-14.1||||0.259|TWO_SIDED|95.0|-37.4|9.2|||Cochran-Mantel-Haenszel|||Day 28||9.2|-37.4|0.2590
91640352|NCT04409262|183172531|SUPERIORITY||Weighted % difference|-14.6||||0.229|TWO_SIDED|95.0|-37.0|7.8|||Cochran-Mantel-Haenszel|||Day 60||7.8|-37.0|0.2290
91640353|NCT04409262|183172532|SUPERIORITY||Mean Difference (Final Values)|3.1125||||0.2434|TWO_SIDED|95.0|-2.16|8.38|||Regression, Linear|||||8.38|-2.16|0.2434
91640354|NCT04409262|183172533|SUPERIORITY||Weighted % difference|0.6||||0.8222|TWO_SIDED|95.0|-4.4|5.6|||Cochran-Mantel-Haenszel|||Day 14||5.6|-4.4|0.8222
91640355|NCT04409262|183172533|SUPERIORITY||Weighted % difference|-1.3||||0.6944|TWO_SIDED|95.0|-7.8|5.2|||Cochran-Mantel-Haenszel|||Day 28||5.2|-7.8|0.6944
91640356|NCT04409262|183172533|SUPERIORITY||Weighted % difference|-3.0||||0.3919|TWO_SIDED|95.0|-10.1|4.0|||Cochran-Mantel-Haenszel|||Day 60||4.0|-10.1|0.3919
91640357|NCT04409262|183172534|SUPERIORITY||Hazard Ratio (HR)|0.957||||0.6778|TWO_SIDED|95.0|0.78|1.18|||Log Rank|||||1.18|0.78|0.6778
91640358|NCT04409262|183172535|SUPERIORITY||Weighted % difference|-0.9||||0.7692|TWO_SIDED|95.0|-8.7|6.8|||Cochran-Mantel-Haenszel|||||6.8|-8.7|0.7692
91640359|NCT04409262|183172536|SUPERIORITY||Weighted % difference|-0.3||||0.9334|TWO_SIDED|95.0|-7.8|7.2|||Cochran-Mantel-Haenszel|||||7.2|-7.8|0.9334
91640360|NCT01738672|183172539|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
91640361|NCT01738672|183172540|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
91640362|NCT01738672|183172541|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
91640363|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.0001
91640364|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
91640365|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
91640366|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of thrombocytopenia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
91640367|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
91485606|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.265|||||TWO_SIDED|95.0|0.998|1.603|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.603|0.998|
91485607|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.999|||||TWO_SIDED|95.0|0.791|1.262|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.262|0.791|
91640368|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
91640369|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
91640370|NCT00948896|183172562|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Daily TS arm compare with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the daily TS arm||||<0.01
91640371|NCT00948896|183172564|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|7.0||||0.57|TWO_SIDED|95.0|-19.0|28.0|||Negative Binomial Regression||The no chemoprevention arm is the reference group.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||28|-19|0.57
91640372|NCT00948896|183172564|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|28.0||||0.01|TWO_SIDED|95.0|7.0|44.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||44|7|0.01
91640373|NCT00948896|183172564|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|58.0|||<|0.001|TWO_SIDED|95.0|45.0|67.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||67|45|<0.001
91640374|NCT00948896|183172565|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|9.0||||0.065|TWO_SIDED|95.0|-35.0|38.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||38|-35|0.065
91640375|NCT00948896|183172565|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|49.0||||0.001|TWO_SIDED|95.0|23.0|66.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||66|23|0.001
91640376|NCT00948896|183172565|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|80.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||80|53|<0.001
91640377|NCT01590810|183172591|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.15||0.503|TWO_SIDED|95.0|-1.59|3.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.15|-1.59|0.503
91673755|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.46|-0.63|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.63|-1.46|<.0001
91673756|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.49|-0.66|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.66|-1.49|<.0001
91640378|NCT01590810|183172591|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.86|-1.55|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.55|-2.86|<0.0001
91716532|NCT04379921|183324794|OTHER|||||||0.59932922||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to NDI||||0.59932922
91716533|NCT04379921|183324794|OTHER|||||||0.3581397||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to ODI||||0.35813970
91485608|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.558|0.897|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.897|0.558|
91716534|NCT04379921|183324795|OTHER|||||||0.0909144||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to SF-36||||0.09091440
91485609|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.861|||||TWO_SIDED|95.0|0.681|1.089|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.089|0.681|
91485610|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.596|0.956|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.956|0.596|
91640379|NCT01590810|183172591|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.23|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-10.13|-6.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.34|-10.13|<0.0001
91640380|NCT01590810|183172591|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.84|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.1|-4.58|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.58|-9.10|<0.0001
91640381|NCT01590810|183172591|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.41|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001|TWO_SIDED|95.0|-12.89|-7.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.92|-12.89|<0.0001
91640382|NCT01590810|183172592|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.4||0.052|TWO_SIDED|95.0|-5.79|0.02|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.02|-5.79|0.052
91640383|NCT01590810|183172592|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.46|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.49|-1.43|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.43|-9.49|0.010
91640384|NCT01590810|183172592|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.49|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.2|-4.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.79|-14.20|<0.001
91640385|NCT01590810|183172592|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.02|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-16.51|-7.52|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.52|-16.51|<0.0001
91716535|NCT04379921|183324795|OTHER|||||||0.12858419||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to EQ-5D||||0.12858419
91716536|NCT04379921|183324795|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to PROMIS||||0.95547874
91716537|NCT04379921|183324795|OTHER|||||||0.9304017||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to NDI||||0.93040170
91716538|NCT04379921|183324795|OTHER|||||||0.38647114||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to ODI||||0.38647114
91716539|NCT04379921|183324795|OTHER|||||||0.0909144||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to SF-36||||0.09091440
91485611|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.548|||||TWO_SIDED|95.0|0.434|0.693|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.693|0.434|
91485612|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.51|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.817|0.510|
91640386|NCT01590810|183172592|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-12.93|-6.53|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.53|-12.93|<0.0001
91640387|NCT01590810|183172593|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.61||0.48|TWO_SIDED|95.0|-16.44|8.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.25|-16.44|0.480
91640388|NCT01590810|183172593|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.79|STANDARD_ERROR_OF_MEAN|5.72||0.086|TWO_SIDED|95.0|-23.37|1.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.79|-23.37|0.086
91640389|NCT01590810|183172593|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.51|STANDARD_ERROR_OF_MEAN|5.15||0.006|TWO_SIDED|95.0|-28.85|-6.18|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.18|-28.85|0.006
91640390|NCT01590810|183172594|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.21|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.84|-9.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.59|-16.84|<0.0001
91640391|NCT01590810|183172594|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|-13.94|-6.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.45|-13.94|<0.0001
91485613|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.79|||||TWO_SIDED|95.0|0.625|1.0|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.000|0.625|
91485614|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.56|||||TWO_SIDED|95.0|0.441|0.71|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.710|0.441|
91673757|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0024|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.12|0.0024
91640392|NCT01590810|183172594|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.82|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.45|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.45|<0.0001
91640393|NCT01590810|183172594|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.84|STANDARD_ERROR_OF_MEAN|1.75|<|0.0001|TWO_SIDED|95.0|-16.49|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.49|<0.0001
91640394|NCT01590810|183172595|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|1.18||0.061|TWO_SIDED|95.0|-4.73|0.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.11|-4.73|0.061
91640395|NCT01590810|183172595|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.23|STANDARD_ERROR_OF_MEAN|0.86||0.016|TWO_SIDED|95.0|-4.0|-0.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.45|-4.00|0.016
91640396|NCT01590810|183172595|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-14.42|-8.82|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.82|-14.42|<0.0001
91640397|NCT01590810|183172595|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.15|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-11.34|-4.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.96|-11.34|<0.0001
91640398|NCT01590810|183172595|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.78|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.81|-12.75|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.75|-20.81|<0.0001
91640399|NCT01590810|183172596|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|1.26||0.029|TWO_SIDED|95.0|-5.56|-0.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.34|-5.56|0.029
91640400|NCT01590810|183172596|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|2.19||0.005|TWO_SIDED|95.0|-11.29|-2.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.22|-11.29|0.005
91640401|NCT01590810|183172596|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.48|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-20.03|-6.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.93|-20.03|<0.001
91640402|NCT01590810|183172596|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.33|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-21.98|-14.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-14.68|-21.98|<0.0001
91640403|NCT01590810|183172596|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.24|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.29|-12.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.19|-20.29|<0.0001
91640404|NCT01590810|183172597|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|2.51||0.539|TWO_SIDED|95.0|-7.12|3.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.93|-7.12|0.539
91640405|NCT01590810|183172597|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|3.12||0.113|TWO_SIDED|95.0|-12.23|1.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.50|-12.23|0.113
91640406|NCT01590810|183172597|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-19.69|-8.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.91|-19.69|<0.001
91640407|NCT01590810|183172598|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|-15.62|-9.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.11|-15.62|<0.0001
91640408|NCT01590810|183172598|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.58|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-13.74|-7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.42|-13.74|<0.0001
91640409|NCT01590810|183172598|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-16.12|-11.13|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-11.13|-16.12|<0.0001
91640410|NCT01590810|183172598|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.96|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-15.85|-10.08|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-10.08|-15.85|<0.0001
91640411|NCT01590810|183172599|SUPERIORITY_OR_OTHER||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.75||0.175|TWO_SIDED|95.0|-0.5|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.60|-0.50|0.175
91640412|NCT01590810|183172599|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.18||0.076|TWO_SIDED|95.0|-0.25|4.61|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.61|-0.25|0.076
91640413|NCT01590810|183172599|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|1.04|3.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.32|1.04|0.001
91640414|NCT01590810|183172599|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|3.14|8.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.15|3.14|<0.0001
91640415|NCT01590810|183172599|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|0.74||0.008|TWO_SIDED|95.0|0.63|3.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.67|0.63|0.008
91640416|NCT01590810|183172600|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.39||0.557|TWO_SIDED|95.0|-3.7|2.05|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.05|-3.70|0.557
91640417|NCT01590810|183172600|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.05||0.175|TWO_SIDED|95.0|-3.65|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.70|-3.65|0.175
91716540|NCT04379921|183324795|OTHER|||||||0.12858419||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to EQ-5D||||0.12858419
91716541|NCT04379921|183324795|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to PROMIS||||0.95547874
91716542|NCT04379921|183324795|OTHER|||||||0.9304017||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to NDI||||0.93040170
91716543|NCT04379921|183324795|OTHER|||||||0.38647114||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to ODI||||0.38647114
91716544|NCT04379921|183324796|OTHER|||||||0.14778771||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to SF-36||||0.14778771
91716545|NCT04379921|183324796|OTHER|||||||0.36288455||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to EQ-5D||||0.36288455
91716546|NCT04379921|183324796|OTHER|||||||0.95547874|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).||Analysis of correlation: steps to PROMIS||||0.95547874
91485615|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.681|||||TWO_SIDED|95.0|0.538|0.862|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.862|0.538|
91716547|NCT04379921|183324796|OTHER|||||||0.65291937||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to NDI||||0.65291937
91793068|NCT04831216|183463866|OTHER|||||||0.6794||||||The p-value reflects results of analysis of change in DMSES scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.6794
91485616|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.597|||||TWO_SIDED|95.0|0.47|0.757|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.757|0.470|
91716548|NCT04379921|183324796|OTHER|||||||0.61429132|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).||Analysis of correlation: steps to ODI||||0.61429132
91716549|NCT04379921|183324796|OTHER|||||||0.1589642||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to SF-36||||0.15896420
91716550|NCT04379921|183324796|OTHER|||||||0.39253325||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to EQ-5D||||0.39253325
91716551|NCT04379921|183324796|OTHER|||||||0.99526258||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to PROMIS||||0.99526258
91485617|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.434|||||TWO_SIDED|95.0|0.342|0.549|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.549|0.342|
91640418|NCT01590810|183172600|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.52||0.951|TWO_SIDED|95.0|-3.04|3.23|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.23|-3.04|0.951
91716552|NCT04379921|183324796|OTHER|||||||0.65291937||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to NDI||||0.65291937
91716553|NCT04379921|183324796|OTHER|||||||0.67694276||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to ODI||||0.67694276
91716554|NCT04379921|183324797|OTHER|||||||0.06340316||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to SF-36||||0.06340316
91716555|NCT04379921|183324797|OTHER|||||||0.08121447||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to EQ-5D||||0.08121447
91716556|NCT04379921|183324797|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to PROMIS||||0.95547874
91716557|NCT04379921|183324797|OTHER|||||||0.59932922||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to NDI||||0.59932922
91716558|NCT04379921|183324797|OTHER|||||||0.3581397||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to ODI||||0.35813970
91716559|NCT04379921|183324797|OTHER|||||||0.06340316||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to SF-36||||0.06340316
91716560|NCT04379921|183324797|OTHER|||||||0.08121447||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to EQ-5D||||0.08121447
91716561|NCT04379921|183324797|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to PROMIS||||0.95547874
91716562|NCT04379921|183324797|OTHER|||||||0.59932922|||||||Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to NDI||||0.59932922
91716563|NCT04379921|183324797|OTHER|||||||0.3581397||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to ODI||||0.35813970
91716564|NCT04379921|183324798|OTHER|||||||0.52394318||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to SF-36||||0.52394318
91716565|NCT04379921|183324798|OTHER|||||||0.37244637||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to EQ-5D||||0.37244637
91716566|NCT04379921|183324798|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to PROMIS||||0.95547874
91716567|NCT04379921|183324798|OTHER|||||||0.9304017||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to NDI||||0.93040170
91716568|NCT04379921|183324798|OTHER|||||||0.38647114||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: steps to ODI||||0.38647114
91716569|NCT04379921|183324798|OTHER|||||||0.7155239||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to SF-36||||0.71552390
91793069|NCT04831216|183463867|OTHER|||||||0.1043||||||The p-value reflects results of analysis of change in oral health behavior from baseline to post-intervention.|Mixed Models Analysis|Cumulative logit mixed effects model included time, age, household size, gender, race, education, and employment.||Cumulative logit mixed effects model (using PROC GLIMMIX) for repeated measures used all available participant data. This model is specifically designed for ordinal outcomes. Analyses do not include imputed missing values.||||0.1043
91716570|NCT04379921|183324798|OTHER|||||||0.35456143||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to EQ-5D||||0.35456143
91716571|NCT04379921|183324798|OTHER|||||||0.95547874||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to PROMIS||||0.95547874
91716572|NCT04379921|183324798|OTHER|||||||0.9304017||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to NDI||||0.93040170
91716573|NCT04379921|183324798|OTHER|||||||0.42512141||||||The a priori threshold for statistical significance is \< 0.05. The p-value is adjusted using the Benjamini-Hochberg (BH method).|Wilcoxon (Mann-Whitney)|||Analysis of correlation: distance (meters) to ODI||||0.42512141
91716574|NCT04275973|183324816|SUPERIORITY|||||||0.649|||||||t-test, 2 sided|||No Intervention vs AFO||||0.649
91716575|NCT04275973|183324816|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||No Intervention vs FES||||0.513
91716576|NCT04275973|183324816|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||AFO vs FES||||0.617
91716577|NCT00791219|183324840|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|6.47|||||ONE_SIDED|95.0|-1.77||||||||||-1.77|
91716578|NCT00791219|183324840|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
91716579|NCT00791219|183324841|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|10.38|||||ONE_SIDED|95.0|0.92|||||||To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|||0.92|
91716580|NCT00791219|183324841|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
91485618|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.511|||||TWO_SIDED|95.0|0.403|0.647|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.647|0.403|
91485619|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.56|0.896|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.896|0.560|
91716581|NCT00791219|183324842|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|3.17|||||ONE_SIDED|95.0|-10.62||||||||||-10.62|
91485620|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.862|||||TWO_SIDED|95.0|0.683|1.088|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.088|0.683|
91640419|NCT01590810|183172600|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|1.34|3.88|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.88|1.34|<0.001
91640420|NCT01590810|183172600|SUPERIORITY_OR_OTHER||LS Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|3.0|6.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.24|3.00|<0.0001
91640421|NCT01590810|183172601|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|1.16||0.241|TWO_SIDED|95.0|-4.01|1.12|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.12|-4.01|0.241
91640422|NCT01590810|183172601|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|2.07||0.664|TWO_SIDED|95.0|-3.63|5.48|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.48|-3.63|0.664
91640423|NCT01590810|183172601|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.13||0.114|TWO_SIDED|95.0|-1.03|8.33|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.33|-1.03|0.114
91640424|NCT01590810|183172602|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42|STANDARD_ERROR_OF_MEAN|4.98||0.385|TWO_SIDED|95.0|-5.96|14.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.81|-5.96|0.385
91640425|NCT01590810|183172602|SUPERIORITY_OR_OTHER||LS Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|5.15||0.385|TWO_SIDED|95.0|-6.16|15.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||15.32|-6.16|0.385
91640426|NCT01590810|183172602|SUPERIORITY_OR_OTHER||LS Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|4.6||0.276|TWO_SIDED|95.0|-4.44|14.74|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.74|-4.44|0.276
91640427|NCT01590810|183172602|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|4.94||0.069|TWO_SIDED|95.0|-0.81|19.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||19.81|-0.81|0.069
91640428|NCT01590810|183172603|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|1.09||0.383|TWO_SIDED|95.0|-1.28|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-1.28|0.383
91640429|NCT01590810|183172603|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.51||0.002|TWO_SIDED|95.0|-2.79|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.70|-2.79|0.002
91640430|NCT01590810|183172603|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.11|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-10.08|-6.14|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.14|-10.08|<0.0001
91640431|NCT01590810|183172603|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-9.74|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-9.74|<0.001
91640432|NCT01590810|183172603|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-12.84|-7.78|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.78|-12.84|<0.0001
91640433|NCT01590810|183172604|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|1.62||0.216|TWO_SIDED|95.0|-5.43|1.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.30|-5.43|0.216
91640434|NCT01590810|183172604|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.27||0.046|TWO_SIDED|95.0|-9.51|-0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.10|-9.51|0.046
91640435|NCT01590810|183172604|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.93|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|95.0|-14.1|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-14.10|0.002
91640436|NCT01590810|183172604|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-16.64|-5.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.68|-16.64|<0.001
91640437|NCT01590810|183172604|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.25|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-12.7|-5.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.80|-12.70|<0.0001
91640438|NCT01590810|183172605|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|4.65||0.635|TWO_SIDED|95.0|-12.5|7.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.96|-12.50|0.635
91640439|NCT01590810|183172605|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|5.18||0.143|TWO_SIDED|95.0|-19.58|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-19.58|0.143
91640440|NCT01590810|183172605|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.51|STANDARD_ERROR_OF_MEAN|4.32||0.004|TWO_SIDED|95.0|-25.01|-6.01|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.01|-25.01|0.004
91640441|NCT01590810|183172606|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.84|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-13.79|-7.89|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.89|-13.79|<0.0001
91640442|NCT01590810|183172606|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-11.18|-5.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.91|-11.18|<0.0001
91485621|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.755|||||TWO_SIDED|95.0|0.597|0.954|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.954|0.597|
91793070|NCT04831216|183463868|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in PAID-5 scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
91485622|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.549|||||TWO_SIDED|95.0|0.435|0.692|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.692|0.435|
91673758|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0078|TWO_SIDED|95.0|-1.03|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.03|0.0078
91673759|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.35|-0.43|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.35|0.0002
91673760|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.5|-0.57|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.57|-1.50|<.0001
91673761|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0034|TWO_SIDED|95.0|-1.16|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.16|0.0034
91673762|NCT02697773|183241321|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.33|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.33|0.0003
91673763|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.0026|TWO_SIDED|95.0|-1.1|-0.23|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.10|0.0026
91673764|NCT02697773|183241323|SUPERIORITY||Least Mean Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.1|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.10|0.0023
91673765|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.29|0.0002
91673766|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.35|<.0001
91673767|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.0066|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.11|0.0066
91793071|NCT04831216|183463870|OTHER|||||||0.5332||||||The p-value reflects results of analysis of change in number of visits to food pantries in the past 30 days from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.5332
91485623|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.511|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.817|0.511|
91673768|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.1506|TWO_SIDED|95.0|-0.79|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.79|0.1506
91673769|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0021|TWO_SIDED|95.0|-1.25|-0.28|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.28|-1.25|0.0021
91673770|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.25||0.0008|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0008
91673771|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.0167|TWO_SIDED|95.0|-1.09|-0.11|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-1.09|0.0167
91793072|NCT04831216|183463871|OTHER|||||||0.0468||||||The p-value reflects results of analysis of change in ARMS-D scale scores from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0468
91485624|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.217|||||TWO_SIDED|95.0|0.961|1.541|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.541|0.961|
91640443|NCT01590810|183172606|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.64|STANDARD_ERROR_OF_MEAN|1.34|<|0.0001|TWO_SIDED|95.0|-13.44|-7.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.84|-13.44|<0.0001
91640444|NCT01590810|183172606|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.13|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-13.97|-8.29|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.29|-13.97|<0.0001
91640445|NCT01590810|183172607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.19||0.547|TWO_SIDED|95.0|-3.19|1.73|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.73|-3.19|0.547
91640446|NCT01590810|183172607|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|-2.79|-0.62|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.62|-2.79|0.004
91640447|NCT01590810|183172607|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.23|-2.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.94|-6.23|<0.0001
91640448|NCT01590810|183172607|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.37|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.98|-1.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.76|-4.98|<0.001
91640449|NCT01590810|183172607|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.92|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-8.24|-3.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.59|-8.24|<0.0001
91640450|NCT01590810|183172608|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|1.33||0.017|TWO_SIDED|95.0|-6.19|-0.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.67|-6.19|0.017
91640451|NCT01590810|183172608|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|1.35|<|0.001|TWO_SIDED|95.0|-8.43|-2.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.84|-8.43|<0.001
91485625|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.066|||||TWO_SIDED|95.0|0.841|1.352|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.352|0.841|
91640452|NCT01590810|183172608|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.99|STANDARD_ERROR_OF_MEAN|1.91||0.005|TWO_SIDED|95.0|-9.94|-2.04|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.04|-9.94|0.005
91640453|NCT01590810|183172608|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.9|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-10.90|<0.001
91640454|NCT01590810|183172608|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.22|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|-7.76|-2.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.69|-7.76|<0.001
91640455|NCT01590810|183172609|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.93|STANDARD_ERROR_OF_MEAN|6.52||0.311|TWO_SIDED|95.0|-21.27|7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.42|-21.27|0.311
91640456|NCT01590810|183172609|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.87|STANDARD_ERROR_OF_MEAN|6.62||0.078|TWO_SIDED|95.0|-27.44|1.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.69|-27.44|0.078
91640457|NCT01590810|183172609|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.03|STANDARD_ERROR_OF_MEAN|6.29||0.027|TWO_SIDED|95.0|-29.87|-2.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.19|-29.87|0.027
91793073|NCT04831216|183463874|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in days per week following general healthful diet from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
91793074|NCT04831216|183463875|OTHER|||||||0.0649||||||The p-value reflects results of analysis of change in days per week following specific diet recommendations from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0649
91485626|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.775|||||TWO_SIDED|95.0|0.612|0.981|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.981|0.612|
91673772|NCT02697773|183241323|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073|TWO_SIDED|95.0|-1.17|-0.18|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.17|0.0073
91673773|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.09|0.0058
91673774|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.31|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.31|0.0002
91673775|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.44|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.44|<.0001
91673776|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.56|-0.64|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.64|-1.56|<.0001
91673777|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.0091|TWO_SIDED|95.0|-1.11|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.11|0.0091
91485627|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.912|||||TWO_SIDED|95.0|0.719|1.157|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.157|0.719|
91673778|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.24||0.0668|TWO_SIDED|95.0|-0.92|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.92|0.0668
91673779|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.26||0.0011|TWO_SIDED|95.0|-1.36|-0.34|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.36|0.0011
91793075|NCT04831216|183463876|OTHER|||||||0.0049||||||The p-value reflects results of analysis of change in days per week engaging in exercise from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0049
91485628|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.876|||||TWO_SIDED|95.0|0.692|1.109|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.109|0.692|
91716582|NCT00791219|183324842|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
91793076|NCT04831216|183463877|OTHER|||||||0.0086||||||The p-value reflects results of analysis of change in days per week conducted blood glucose testing from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0086
91793077|NCT04831216|183463878|OTHER|||||||0.0243||||||The p-value reflects results of analysis of change in days per week conducting food checks from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0243
91716583|NCT00791219|183324845|NON_INFERIORITY|If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|-0.57|||||ONE_SIDED|95.0|-12.91|||||||If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|||-12.91|
91485629|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.637|||||TWO_SIDED|95.0|0.504|0.804|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.804|0.504|
91485630|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.75|||||TWO_SIDED|95.0|0.593|0.949|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.949|0.593|
91640458|NCT01590810|183172610|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.77|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|TWO_SIDED|95.0|-12.9|-6.65|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.65|-12.90|<0.0001
91640459|NCT01590810|183172610|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|2.1||0.003|TWO_SIDED|95.0|-11.57|-2.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.81|-11.57|0.003
91640460|NCT01590810|183172610|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.19|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-12.4|-3.98|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.98|-12.40|0.001
91640461|NCT01590810|183172610|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-11.69|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-11.69|0.001
91640462|NCT01590810|183172611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.04||0.765|TWO_SIDED|95.0|-1.82|2.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.45|-1.82|0.765
91640463|NCT01590810|183172611|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.56||0.023|TWO_SIDED|95.0|-2.49|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.20|-2.49|0.023
91640464|NCT01590810|183172611|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.18|-4.36|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.36|-9.18|<0.0001
91793078|NCT04831216|183463879|OTHER|||||||0.2861||||||The p-value reflects results of analysis of change in smoking status (yes/no) from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2861
91527502|NCT04534114|182930302|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.63||||0.605|TWO_SIDED|95.0|0.1|3.75|||Log Rank|||||3.75|0.10|0.605
91640465|NCT01590810|183172611|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.45|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.46|-1.44|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.44|-9.46|0.010
91640466|NCT01590810|183172611|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.61|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-11.28|-5.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.94|-11.28|<0.0001
91640467|NCT01590810|183172612|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.02|STANDARD_ERROR_OF_MEAN|1.39||0.16|TWO_SIDED|95.0|-4.89|0.86|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.86|-4.89|0.160
91640468|NCT01590810|183172612|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|1.97||0.039|TWO_SIDED|95.0|-8.4|-0.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.24|-8.40|0.039
91640469|NCT01590810|183172612|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.75|STANDARD_ERROR_OF_MEAN|2.34||0.003|TWO_SIDED|95.0|-12.58|-2.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.92|-12.58|0.003
91640470|NCT01590810|183172612|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.79|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.49|-5.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.09|-14.49|<0.001
91640471|NCT01590810|183172612|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.31|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-11.3|-5.31|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.31|-11.30|<0.0001
91640472|NCT01590810|183172613|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|4.0||0.675|TWO_SIDED|95.0|-10.54|7.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.09|-10.54|0.675
91640473|NCT01590810|183172613|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|4.64||0.174|TWO_SIDED|95.0|-16.98|3.46|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.46|-16.98|0.174
91673780|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.48|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.48|0.0002
91673781|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0059|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-1.20|0.0059
91640474|NCT01590810|183172613|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.68|STANDARD_ERROR_OF_MEAN|4.03||0.006|TWO_SIDED|95.0|-22.55|-4.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.81|-22.55|0.006
91640475|NCT01590810|183172614|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.12|STANDARD_ERROR_OF_MEAN|1.49|<|0.0001|TWO_SIDED|95.0|-12.22|-6.03|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.03|-12.22|<0.0001
91640476|NCT01590810|183172614|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.86|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.73|-3.99|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.99|-9.73|<0.0001
91640477|NCT01590810|183172614|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.57|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-11.51|-5.64|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.64|-11.51|<0.0001
91640478|NCT01590810|183172614|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.52|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-12.55|-6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.50|-12.55|<0.0001
91640479|NCT01731600|183172635|OTHER||Incidence rate|0.0|||||ONE_SIDED|97.5||0.067|||||The incidence of inhibitory antibodies was calculated as number of patients with inhibitors during the main phase of the trial divided by number of patients in the main phase of the trial.|A one-sided, upper 97.5% confidence limit was provided based on an exact calculation in the binomial distribution.||0.067||
91640480|NCT02748096|183172677|OTHER||||||<|0.05||||||A p value of less than 0.05 was considered statistically significant for all the radiographic parameters .|t-test, 2 sided|This test applies to comparison between the two treatment arms and assesses all the radiographic parameters||The sample size was calculated from a previous study that used similar radiological assessments to compare OUKAs performed using conventional instrumentation and computer navigation. In this study, the standard deviation of the tibia varus/valgus angle for the control group was 3.6°. Assuming a minimum clinically important difference of 3°, the SMD would be 0.8. Hence with a power of 0.8 and significance level of 0.05, a total sample size of 44 patients (22 in each group) was required.||||<0.05
91640481|NCT02748096|183172678|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91640482|NCT02748096|183172679|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91640483|NCT02389621|183172711|SUPERIORITY||Difference|36.7|||<|0.0001|TWO_SIDED|95.0|24.9|48.5||Statistical tests were performed at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted using the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||48.5|24.9|<0.0001
91640484|NCT02389621|183172712|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|34.8|||<|0.0001|TWO_SIDED|95.0|22.8|46.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||46.8|22.8|<0.0001
91640485|NCT02389621|183172713|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|52.5|||<|0.0001|TWO_SIDED|95.0|42.0|62.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||62.9|42.0|<0.0001
91640486|NCT02389621|183172714|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.||||||0.0002|||||||van Elteren test|van Elteren test stratified by platelet transfusion during the study.||||||0.0002
91640487|NCT02389621|183172715|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
91640488|NCT03413618|183172789|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91640489|NCT03413618|183172790|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
91640490|NCT03413618|183172792|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91640491|NCT03413618|183172793|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91640492|NCT03413618|183172795|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
91640493|NCT03413618|183172796|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91640494|NCT03246152|183172802|OTHER||||||>|0.05|||||||Pearson's correlation coefficient|||Correlation between change in BCVA and the pre treatment, post treatment, and change in vascular density following 3-6 injections was performed.||||>0.05
91640495|NCT00423137|183172803|OTHER||Difference of least square means|-1.385|STANDARD_ERROR_OF_MEAN|2.181||0.5305|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.||||||0.5305
91673782|NCT02697773|183241325|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.25||0.0005|TWO_SIDED|95.0|-1.39|-0.39|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.39|0.0005
91673783|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|1.56||0.6984|TWO_SIDED|95.0|-2.48|3.7|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.70|-2.48|0.6984
91673784|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|1.6||0.2953|TWO_SIDED|95.0|-4.84|1.48|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.48|-4.84|0.2953
91673785|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|4.14||0.1911|TWO_SIDED|95.0|-13.59|2.74|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.74|-13.59|0.1911
91673786|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-5.59|STANDARD_ERROR_OF_MEAN|4.2||0.1857|TWO_SIDED|95.0|-13.89|2.71|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.71|-13.89|0.1857
91485631|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.727|||||TWO_SIDED|95.0|0.574|0.919|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.919|0.574|
91485632|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.856|||||TWO_SIDED|95.0|0.675|1.084|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.084|0.675|
91673787|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.21||0.1707|TWO_SIDED|95.0|-14.12|2.52|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.52|-14.12|0.1707
91673788|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|4.29||0.138|TWO_SIDED|95.0|-14.85|2.07|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.07|-14.85|0.1380
91673789|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|2.42||0.1151|TWO_SIDED|95.0|-8.58|0.94|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.94|-8.58|0.1151
91673790|NCT02697773|183241328|SUPERIORITY||Least Square Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|2.41||0.1195|TWO_SIDED|95.0|-8.51|0.98|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.98|-8.51|0.1195
91673791|NCT02697773|183241339|SUPERIORITY||Odds Ratio (OR)|0.48||||0.1444|TWO_SIDED|95.0|0.18|1.29|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.18|0.1444
91673792|NCT02697773|183241339|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0335|TWO_SIDED|95.0|0.09|0.91|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.09|0.0335
91673793|NCT02697773|183241340|SUPERIORITY|||||||0.0809||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0809
91673794|NCT02697773|183241340|SUPERIORITY|||||||0.0239||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0239
91673795|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0761|TWO_SIDED|95.0|0.48|1.04|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.48|0.0761
91673796|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.96|0.44|0.0312
91527857|NCT06173570|182930694|SUPERIORITY||Mean Difference (Net)|-32.28|||<|0.001|TWO_SIDED|95.0|-40.54|-24.02|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-24.02|-40.54|<0.001
91793079|NCT04831216|183463880|OTHER|||||||0.9933||||||The p-value reflects results of analysis of change in days per week adhering to prescribed medications from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.9933
91793080|NCT03470441|183463897|OTHER||||||||||||||descriptive||||As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoints (Arrhythmias of Interest at 48 hours and 14 days for overall and anterior infarcts) was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301's effect on arrhythmias.|||
91793081|NCT03470441|183463902|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.32|TWO_SIDED|95.15|-10.8|3.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||3.1|-10.8|0.32
91793082|NCT03470441|183463904|SUPERIORITY||Median Difference (Final Values)|-4.4||||0.46|TWO_SIDED|95.16|-20.2|12.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test Comparing placebo to anterior infarcts FDY-5301 treated subjects (low, intermediate, and high) combined into one group.||12.10|-20.2|0.46
91793083|NCT03470441|183463910|SUPERIORITY||Median Difference (Final Values)|3.7||||0.25|TWO_SIDED|95.11|-3.6|10.6|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||10.6|-3.6|0.25
91485633|NCT00973349|182844334|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.178|||||TWO_SIDED|95.0|0.931|1.489|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.489|0.931|
91640496|NCT00423137|183172804|OTHER||Difference of least square means|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1498|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1498
91673797|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0262|TWO_SIDED|95.0|0.45|0.95|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.95|0.45|0.0262
91485634|NCT05597020|182844359|SUPERIORITY||Least Square mean difference vs placebo|20.9||||0.002|TWO_SIDED|95.0|8.0|33.7|||Mixed Models Analysis|Treatment, period, week within period, and interaction of treatment and week were factors; baseline sTST assessment was covariate.||||33.7|8.0|0.002
91485635|NCT05736224|182844361|SUPERIORITY|||||||0.003||||||No sunscreen compared to test sunscreen|t-test, 2 sided|||||||0.003
91485636|NCT01015131|182844368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1521|||<|0.01|TWO_SIDED|90.0|0.0932|0.2111|||paired t-test|||||0.2111|0.0932|<0.01
91673798|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.54||||0.0013|TWO_SIDED|95.0|0.37|0.79|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.79|0.37|0.0013
91485637|NCT03029702|182844379|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
91640497|NCT00423137|183172807|OTHER||Difference of least square means|0.335|STANDARD_ERROR_OF_MEAN|0.434||0.4472|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4472
91673799|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6706|TWO_SIDED|95.0|0.64|1.33|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.64|0.6706
91485638|NCT03029702|182844380|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
91485639|NCT03029702|182844381|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
91485640|NCT03029702|182844382|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
91485641|NCT03029702|182844383|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
91485642|NCT03029702|182844384|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
91485643|NCT03029702|182844385|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
91640498|NCT00423137|183172808|OTHER||Difference of least square means|-0.141|STANDARD_ERROR_OF_MEAN|0.342||0.6829|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.6829
91640499|NCT00423137|183172809|OTHER||Difference of least square means|0.571|STANDARD_ERROR_OF_MEAN|0.391||0.1565|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1565
91793084|NCT03470441|183463912|SUPERIORITY||Median Difference (Final Values)|4.9||||0.31|TWO_SIDED|95.16|-7.0|16.9|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to anterior infarcts FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||16.9|-7|0.31
91793085|NCT06269484|183463916|OTHER|No test was performed.|Risk Difference (RD)|0.0|||||TWO_SIDED|90.0|-0.24|0.24|||Proportions used for comparison|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Risk difference for proportions presented. The associated CI is the exact unconditional 90% (two-sided) computed based on score statistic.|||0.24|-0.24|
91793086|NCT06269484|183463916|OTHER|No test was performed.|Risk Difference (RD)|0.33|||||TWO_SIDED|90.0|0.09|0.55|||Proportions used for comparison|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Risk difference for proportions presented. The associated CI is the exact unconditional 90% (two-sided) computed based on score statistic.|||0.55|0.09|
91793087|NCT06269484|183463916|OTHER|No test was performed.|Risk Difference (RD)|0.33|||||TWO_SIDED|90.0|0.09|0.55|||Proportions used for comparison|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Risk difference for proportions presented. The associated CI is the exact unconditional 90% (two-sided) computed based on score statistic.|||0.55|0.09|
91716584|NCT00791219|183324846|SUPERIORITY||Mean Difference (Final Values)|0.0018|||<|0.05|TWO_SIDED|||||It the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated.|A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
91716585|NCT00791219|183324846|SUPERIORITY||Median Difference (Final Values)|0.0853|||<|0.05|TWO_SIDED||||||A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
91716586|NCT00767572|183324847|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance threshold p\<0.05|t-test, 2 sided|||Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin||||>0.05
91716587|NCT06831344|183324870|EQUIVALENCE|The two treatments were deemed equivalent if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM Percentage (%)|113.26|||||TWO_SIDED|90.0|104.86|122.33|||||Geometric least square mean (GLSM) ratios were calculated by taking antilog of difference of least square means and associated 90% confidence intervals (CIs) from linear mixed effect model analyzing natural logarithms of corresponding PK parameters.|||122.33|104.86|
91673800|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.69|1.43|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.43|0.69|0.9720
91673801|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.89||||0.5311|TWO_SIDED|95.0|0.61|1.29|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.61|0.5311
91673802|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.77||||0.1712|TWO_SIDED|95.0|0.53|1.12|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.12|0.53|0.1712
91673803|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7475|TWO_SIDED|95.0|0.73|1.54|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.54|0.73|0.7475
91673804|NCT02697773|183241341|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6564|TWO_SIDED|95.0|0.63|1.33|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.63|0.6564
91673805|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.11||0.4833|TWO_SIDED|95.0|0.73|1.16|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.73|0.4833
91673806|NCT02697773|183241343|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.1||0.0942|TWO_SIDED|95.0|0.65|1.03|||Negative binomial model|||||1.03|0.65|0.0942
91673807|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.12||0.3371|TWO_SIDED|95.0|0.67|1.15|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.67|0.3371
91793088|NCT06269484|183463917|OTHER|No test was performed.|Mean Difference (Net)|-1.72|||||TWO_SIDED|90.0|-2.82|-0.62|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-0.62|-2.82|
91485644|NCT03029702|182844386|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
91485645|NCT02452697|182844390|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.40
91673808|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.11||0.0508|TWO_SIDED|95.0|0.58|1.0|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.58|0.0508
91673809|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.14||0.728|TWO_SIDED|95.0|0.71|1.27|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.71|0.7280
91673810|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3244|TWO_SIDED|95.0|0.65|1.15|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.65|0.3244
91673811|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.16||0.5681|TWO_SIDED|95.0|0.65|1.27|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.65|0.5681
91485646|NCT02791399|182844415|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.12|||<|0.05|TWO_SIDED|95.0|-2.45|0.2|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.20|-2.45|<0.05
91793089|NCT06269484|183463917|OTHER|No test was performed.|Mean Difference (Net)|-0.55|||||TWO_SIDED|90.0|-1.66|0.56|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.56|-1.66|
91485647|NCT02791399|182844416|EQUIVALENCE|Our analysis examined the estimated probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-0.04|||<|0.05|TWO_SIDED|95.0|-0.15|0.06|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.06|-0.15|<0.05
91640500|NCT00423137|183172810|OTHER||Difference of least square means|1.081|STANDARD_ERROR_OF_MEAN|1.185||0.3709|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.3709
91640501|NCT00423137|183172811|OTHER||Difference of least square means|-52.083|STANDARD_ERROR_OF_MEAN|16.48||0.0044|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0044
91640502|NCT00423137|183172812|OTHER||Difference of least square means|-67.012|STANDARD_ERROR_OF_MEAN|21.29||0.0056|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0056
91640503|NCT00423137|183172813|OTHER||Difference of least square means|-62.571|STANDARD_ERROR_OF_MEAN|18.42||0.0025|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0025
91640504|NCT00423137|183172814|OTHER||Difference of least square means|-40.067|STANDARD_ERROR_OF_MEAN|18.8||0.0439|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0439
91640505|NCT00423137|183172815|OTHER||Difference of least square means|-57.46|STANDARD_ERROR_OF_MEAN|21.3||0.0129|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0129
91640506|NCT00423137|183172816|OTHER||Difference of least square means|-55.332|STANDARD_ERROR_OF_MEAN|17.11||0.0037|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0037
91640507|NCT00423137|183172817|OTHER||Difference of least square means|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9076|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.9076
91640508|NCT00423137|183172818|OTHER||Difference of least square means|-13453.0|STANDARD_ERROR_OF_MEAN|16118.0||0.4121|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4121
91640509|NCT00423137|183172819|OTHER||Difference of least square means|-78.619|STANDARD_ERROR_OF_MEAN|298.91||0.7948|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.7948
91640510|NCT00423137|183172820|OTHER||Difference of least square means|0.195|STANDARD_ERROR_OF_MEAN|0.101||0.064|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0640
91640511|NCT00423137|183172821|OTHER||Difference of least square means|0.007|STANDARD_ERROR_OF_MEAN|0.004||0.0587|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0587
91640512|NCT01005810|183172822|SUPERIORITY||Odds Ratio (OR)|2.35||||0.029|TWO_SIDED|95.0|1.05|5.24|||Regression, Logistic|||||5.24|1.05|0.029
91640513|NCT04196023|183172823|SUPERIORITY|||||||0.2||||||p-value was calculated using GLM. Statistical significance was determined using an alpha level of 0.05.|general linear model|adjusted for age, sex, education and baseline overall MoCA score||||||0.20
91640514|NCT04196023|183172824|SUPERIORITY|||||||0.9||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.90
91640515|NCT04196023|183172825|SUPERIORITY|||||||0.01||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.01
91793090|NCT06269484|183463917|OTHER|No test was performed.|Mean Difference (Net)|1.17|||||TWO_SIDED|90.0|0.09|2.25|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||2.25|0.09|
91793091|NCT06269484|183463918|OTHER|No test was performed.|Mean Difference (Net)|-1.45|||||TWO_SIDED|90.0|-2.48|-0.43|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-0.43|-2.48|
91640516|NCT04196023|183172826|SUPERIORITY|||||||0.05||||||p-value was calculated using GLM model and false discovery rate (FDR)-adjustment. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.05
91640517|NCT04359758|183172836|SUPERIORITY|||||||0.14|||||||Chi-squared|||The study was powered assuming 10% genetic testing uptake UC compared to 35% in ST. assuming these uptake rates and a two-tailed alpha of 0.05, a sample size of n=50 per arm would yield greater than 80% power.||||0.14
91640518|NCT04359758|183172836|SUPERIORITY||Odds Ratio (OR)|2.57||||0.039|TWO_SIDED|95.0|1.05|6.29|||Regression, Logistic|||Because education and marital status have been associated with genetic testing participation in prior research, we conducted a follow-up analysis in which we adjusted for education and marital status.||6.29|1.05|0.039
91640519|NCT04359758|183172837|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|101 degrees of freedom.||||||0.13
91640520|NCT04359758|183172838|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|df=102||||||0.78
91640521|NCT04359758|183172839|SUPERIORITY|||||||0.97|||||||ANCOVA|df = 1, 101||Analysis of PROMIS anxiety||||0.97
91793092|NCT06269484|183463918|OTHER|No test was performed.|Mean Difference (Net)|-1.38|||||TWO_SIDED|90.0|-2.42|-0.34|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-0.34|-2.42|
91793093|NCT06269484|183463918|OTHER|No test was performed.|Mean Difference (Net)|0.07|||||TWO_SIDED|90.0|-0.94|1.09|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||1.09|-0.94|
91793094|NCT06269484|183463919|OTHER|No test was performed.|Mean Difference (Net)|-0.3|||||TWO_SIDED|90.0|-1.1|0.49|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.49|-1.10|
91793095|NCT06269484|183463919|OTHER|No test was performed.|Mean Difference (Net)|0.72|||||TWO_SIDED|90.0|-0.09|1.52|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||1.52|-0.09|
91793096|NCT06269484|183463919|OTHER|No test was performed.|Mean Difference (Net)|1.02|||||TWO_SIDED|90.0|0.23|1.81|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||1.81|0.23|
91793097|NCT06269484|183463920|OTHER|No test was performed.|Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.4|0.39|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.39|-0.40|
91793098|NCT06269484|183463920|OTHER|No test was performed.|Mean Difference (Net)|0.53|||||TWO_SIDED|90.0|0.12|0.93|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.93|0.12|
91793099|NCT06269484|183463920|OTHER|No test was performed.|Mean Difference (Net)|0.53|||||TWO_SIDED|90.0|0.14|0.92|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.92|0.14|
91485648|NCT02791399|182844417|NON_INFERIORITY|Pain intensity and pain-related function were tested in non-inferiority analyses, as we hypothesized that the ISOT intervention would not negatively impact pain or function. One-half SD difference in change was considered the appropriate non-inferiority limit.|Non-inferiority analysis|1.6|||||TWO_SIDED|||||||||||||
91485649|NCT02791399|182844418|EQUIVALENCE|This analysis is comparing estimated averages and probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.99|||<|0.05|TWO_SIDED|95.0|-5.83|1.85|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||1.85|-5.83|<0.05
91793100|NCT06269484|183463921|OTHER|No test was performed.|Mean Difference (Net)|-0.22|||||TWO_SIDED|90.0|-0.66|0.22|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.22|-0.66|
91485650|NCT02791399|182844419|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|1.03|||<|0.05|TWO_SIDED|95.0|-6.73|8.8|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||8.80|-6.73|<0.05
91485651|NCT00704912|182844420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5||||0.06|TWO_SIDED|95.0|1.0|6.6|||Log-binomial model|||||6.6|1.0|0.06
91485652|NCT00704912|182844420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3||||0.08|TWO_SIDED|95.0|0.9|6.1|||Log-binomial model|||||6.1|0.9|0.08
91485653|NCT00704912|182844420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.82|TWO_SIDED|95.0|0.5|2.1|||Log-binomial model|||||2.1|0.5|0.82
91485654|NCT00704912|182844421|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.06|TWO_SIDED|95.0|1.0|1.7|||Log-binomial model|||||1.7|1.0|0.06
91640522|NCT04359758|183172839|SUPERIORITY|||||||0.34|||||||ANCOVA|df = 1, 101||Analysis of PROMIS Depression||||0.34
91793101|NCT06269484|183463921|OTHER|No test was performed.|Mean Difference (Net)|0.27|||||TWO_SIDED|90.0|-0.18|0.71|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.71|-0.18|
91793102|NCT06269484|183463921|OTHER|No test was performed.|Mean Difference (Net)|0.49|||||TWO_SIDED|90.0|0.05|0.92|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.92|0.05|
91793103|NCT06269484|183463922|OTHER|No test was performed.|Mean Difference (Net)|-1.775|||||TWO_SIDED|90.0|-2.836|-0.714|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-0.714|-2.836|
91793104|NCT06269484|183463922|OTHER|No test was performed.|Mean Difference (Net)|-0.499|||||TWO_SIDED|90.0|-1.637|0.639|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||0.639|-1.637|
91793105|NCT06269484|183463922|OTHER|No test was performed.|Mean Difference (Net)|1.277|||||TWO_SIDED|90.0|0.183|2.371|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||2.371|0.183|
91793106|NCT06269484|183463923|OTHER|No test was performed.|Mean Difference (Net)|-5.058|||||TWO_SIDED|90.0|-9.7|-0.417|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Note: Model assumption was violated due to skewed data distribution and the results should not be interpreted.|||-0.417|-9.700|
91793107|NCT06269484|183463923|OTHER|No test was performed.|Mean Difference (Net)|-0.056|||||TWO_SIDED|90.0|-4.736|4.624|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Note: Model assumption was violated due to skewed data distribution and the results should not be interpreted.|||4.624|-4.736|
91793108|NCT06269484|183463923|OTHER|No test was performed.|Mean Difference (Net)|5.002|||||TWO_SIDED|90.0|0.388|9.617|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Note: Model assumption was violated due to skewed data distribution and the results should not be interpreted.|||9.617|0.388|
91793109|NCT06269484|183463924|OTHER|No test was performed.|Risk Difference (RD)|-0.08|||||TWO_SIDED|90.0|-0.31|0.15|||Proportions used for comparison|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Risk difference for proportions presented. The associated CI is the exact unconditional 90% (two-sided) computed based on score statistic.|||0.15|-0.31|
91793110|NCT06269484|183463924|OTHER|No test was performed.|Risk Difference (RD)|0.21|||||TWO_SIDED|90.0|0.02|0.41|||Proportions used for comparison|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Risk difference for proportions presented. The associated CI is the exact unconditional 90% (two-sided) computed based on score statistic.|||0.41|0.02|
91485655|NCT00704912|182844421|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.002|TWO_SIDED|95.0|1.1|1.9|||Log-binomial model|||||1.9|1.1|0.002
91485656|NCT00704912|182844421|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.28|TWO_SIDED|95.0|0.7|1.1|||Log-binomial model|||||1.1|0.7|0.28
91640523|NCT01797458|183172840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Twenty-five teeth experienced at least one 'Minor' failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%).|Kruskal-Wallis|||The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.||||0.02
91640524|NCT04753606|183172942|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
91640525|NCT04753606|183172942|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
91640526|NCT04753606|183172943|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
91640527|NCT04753606|183172943|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
91640528|NCT04753606|183172944|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
91640529|NCT04753606|183172944|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
91640530|NCT04753606|183172945|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
91640531|NCT04753606|183172945|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
91640532|NCT04753606|183172946|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
91640533|NCT04753606|183172946|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
91640534|NCT04753606|183172947|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
91640535|NCT04753606|183172947|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
91640536|NCT04753606|183172948|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
91640537|NCT04753606|183172948|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
91485657|NCT00704912|182844422|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.3|-3.8|||Mixed Models Analysis||Lifestyle vs. OCP|||-3.8|-6.3|<.0001
91640538|NCT04753606|183172949|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
91640539|NCT04753606|183172949|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
91485658|NCT00704912|182844422|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.7|||Mixed Models Analysis||Combined vs. OCP|||-3.7|-6.2|<.0001
91485659|NCT00704912|182844422|SUPERIORITY_OR_OTHER||Difference in Mean Change|-0.1||||0.92|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis||Lifestyle vs. Combined|||1.2|-1.3|0.92
91640540|NCT04753606|183172950|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
91640541|NCT04753606|183172950|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
91640542|NCT04753606|183172951|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
91640543|NCT04753606|183172951|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
91640544|NCT04753606|183172952|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
91640545|NCT04753606|183172952|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
91640546|NCT04753606|183172953|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
91640547|NCT04753606|183172953|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
91716588|NCT06831344|183324870|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|107.65|||||TWO_SIDED|90.0|99.67|116.28|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||116.28|99.67|
91716589|NCT06831344|183324870|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|101.19|||||TWO_SIDED|90.0|93.68|109.3|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||109.30|93.68|
91716590|NCT06831344|183324870|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|105.94|||||TWO_SIDED|90.0|98.08|114.43|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||114.43|98.08|
91716591|NCT06831344|183324870|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|95.05|||||TWO_SIDED|90.0|88.0|102.67|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||102.67|88.00|
91716592|NCT06831344|183324870|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|104.69|||||TWO_SIDED|90.0|96.93|113.08|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||113.08|96.93|
91716593|NCT06831344|183324871|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|114.62|||||TWO_SIDED|90.0|107.46|122.24|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||122.24|107.46|
91716594|NCT06831344|183324871|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|110.01|||||TWO_SIDED|90.0|103.14|117.33|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||117.33|103.14|
91485660|NCT00704912|182844423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.6|TWO_SIDED|95.0|0.6|2.2|||GEE||End of intervention compared to baseline.|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||2.2|0.6|0.60
91716595|NCT06831344|183324871|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|106.0|||||TWO_SIDED|90.0|99.39|113.06|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||113.06|99.39|
91716596|NCT06831344|183324871|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|103.87|||||TWO_SIDED|90.0|97.39|110.78|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||110.78|97.39|
91485661|NCT00704912|182844423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001|TWO_SIDED|95.0|1.4|4.3|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||4.3|1.4|0.001
91485662|NCT00704912|182844423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.18|TWO_SIDED|95.0|0.4|1.2|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||1.2|0.4|0.18
91485663|NCT00704912|182844423|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||GEE|||||||0.08
91527858|NCT06173570|182930694|SUPERIORITY||Mean Difference (Net)|-37.63|||<|0.001|TWO_SIDED|95.0|-45.82|-29.44|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-29.44|-45.82|<0.001
91716597|NCT06831344|183324871|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|95.98|||||TWO_SIDED|90.0|89.99|102.37|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||102.37|89.99|
91716598|NCT06831344|183324871|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|97.99|||||TWO_SIDED|90.0|91.87|104.51|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||104.51|91.87|
91716599|NCT06831344|183324872|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|114.01|||||TWO_SIDED|90.0|107.28|121.17|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||121.17|107.28|
91716600|NCT06831344|183324872|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|109.99|||||TWO_SIDED|90.0|103.49|116.9|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||116.90|103.49|
91716601|NCT06831344|183324872|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|106.55|||||TWO_SIDED|90.0|100.26|113.24|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||113.24|100.26|
91716602|NCT06831344|183324872|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|104.31|||||TWO_SIDED|90.0|98.15|110.86|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||110.86|98.15|
91716603|NCT06831344|183324872|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|96.47|||||TWO_SIDED|90.0|90.77|102.53|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||102.53|90.77|
91716604|NCT06831344|183324872|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Ratio of GLSM (%)|97.9|||||TWO_SIDED|90.0|92.11|104.05|||||GLSM ratios were calculated by taking the antilog of the difference of least square means and associated 90% CIs from the linear mixed effect model analyzing the natural logarithms of the corresponding PK parameters.|||104.05|92.11|
91716605|NCT02873689|183324897|SUPERIORITY|||||||0.057|||||||Wilcoxon rank-sum test|||||||0.057
91716606|NCT02873689|183324898|SUPERIORITY|||||||0.268|||||||Wilcoxon rank-sum test|||||||0.268
91716607|NCT00434252|183324904|SUPERIORITY_OR_OTHER||Difference in survival rates|3.5||||0.5724||95.0|-8.7|15.7|||z-test|z-test using the standard errors computed using Greenwood's method.||||15.7|-8.7|0.5724
91716608|NCT00434252|183324905|SUPERIORITY_OR_OTHER||Difference in event rates|12.2||||0.0982||95.0|-2.3|26.6|||z-test|z-test using the standard errors computed using Greenwood's method||||26.6|-2.3|0.0982
91485664|NCT00704912|182844423|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE|||||||0.001
91485665|NCT00704912|182844423|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||GEE|||||||0.22
91485666|NCT02203071|182844448|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
91485667|NCT02203071|182844449|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
91485668|NCT02203071|182844450|SUPERIORITY||||||>|0.11|||||||t-test, 2 sided|||||||>0.11
91485669|NCT02203071|182844451|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
91485670|NCT02203071|182844452|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91485671|NCT02203071|182844453|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91485672|NCT02595970|182844471|SUPERIORITY|adjusted for multiplicity using the Hochberg procedure.|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-24.52|20.59|||t-test, 2 sided|||||20.59|-24.52|<0.0001
91640548|NCT04753606|183172954|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
91716609|NCT02990000|183324924|SUPERIORITY|We used the Optimal Design program to determine the minimum numbers of therapists and patients needed to detect a moderate effect of condition (standardized difference between change rates = .50). Based on this a priori power analysis, we will need a total of 44 therapists and 211 patients to achieve a power of .80 to detect moderate condition effects. Factoring in a 25% dropout rate, enrolling 281 patients should provide sufficient statistical power.|condition effect on weekly change rate|-0.04|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|-0.05|-0.03|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the TOP-CS average z-scores. Given that higher TOP-CS z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.03|-0.05|.02
91716610|NCT02990000|183324925|SUPERIORITY||condition effect on weekly change rate|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.3|-0.02|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the SCL-10 total score. Given that higher SCL-10 scores indicate greater psychological distress, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.02|-0.30|.03
91716611|NCT02990000|183324926|SUPERIORITY||condition effect on weekly change rate|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.65|TWO_SIDED|95.0|-0.33|0.21|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the patient-rated WAI. Given that higher WAI scores indicate better quality therapeutic alliances, positive slopes indicate a weekly increase in alliance during treatment (i.e., a better outcome or more improvement).||0.21|-0.33|.65
91716612|NCT02990000|183324927|SUPERIORITY||condition effect on weekly change rate|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.41|TWO_SIDED|95.0|-0.17|0.07|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the OE subscale of the CEQ. Given that higher OE scores indicate more optimistic expectations, positive slopes indicate a weekly increase in OE during treatment (i.e., a better outcome or more improvement).||0.07|-0.17|.41
91793111|NCT06269484|183463924|OTHER|No test was performed..|Risk Difference (RD)|0.29|||||TWO_SIDED|90.0|0.09|0.49|||Proportions used for comparison|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.|Risk difference for proportions presented. The associated CI is the exact unconditional 90% (two-sided) computed based on score statistic.|||0.49|0.09|
91793112|NCT06269484|183463925|OTHER|No test was performed.|Mean Difference (Net)|-9.4|||||TWO_SIDED|90.0|-15.0|-3.8|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-3.8|-15.0|
91640549|NCT04753606|183172954|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
91640550|NCT04753606|183172955|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
91640551|NCT04753606|183172955|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
91640552|NCT04753606|183172956|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
91640553|NCT04753606|183172956|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
91640554|NCT00489411|183172957|SUPERIORITY_OR_OTHER||Mean Difference|0.73||||0.003|TWO_SIDED|95.0|0.26|1.2|||Wilcoxon (Mann-Whitney)|||||1.20|0.26|0.003
91640555|NCT00489411|183172958|SUPERIORITY_OR_OTHER||Mean Difference|4.4|||||TWO_SIDED|95.0|0.93|7.88||||||||7.88|0.93|
91640556|NCT00489411|183172959|SUPERIORITY_OR_OTHER||Mean Difference|1.58||||0.03|TWO_SIDED|95.0|0.15|3.0|||Wilcoxon (Mann-Whitney)|||||3.00|0.15|0.03
91640557|NCT00489411|183172960|SUPERIORITY_OR_OTHER||Mean difference|1.01|||||TWO_SIDED|95.0|0.36|1.65||||||||1.65|0.36|
91640558|NCT03841331|183172979|SUPERIORITY||Treatment Effect|-1.4||||0.5861|TWO_SIDED|95.0|-13.9|11.1|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used|At Week 10||11.1|-13.9|0.5861
91640559|NCT03841331|183172980|SUPERIORITY||Treatment Effect|-0.7||||0.5651|TWO_SIDED|95.0|-10.1|8.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||8.7|-10.1|0.5651
91640560|NCT03841331|183172980|SUPERIORITY||Treatment Effect|-4.1||||0.7769|TWO_SIDED|95.0|-14.8|6.7|||Cochran-Mantel-Haenszel|||At Week 4|95% Wald confidence intervals for the treatment difference was used.|6.7|-14.8|0.7769
91640561|NCT03841331|183172980|SUPERIORITY||Treatment Effect|2.8||||0.3285|TWO_SIDED|95.0|-9.1|14.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||14.8|-9.1|0.3285
91640562|NCT03841331|183172980|SUPERIORITY||Treatment Effect|-2.3||||0.6525|TWO_SIDED|95.0|-14.4|9.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.8|-14.4|0.6525
91640563|NCT03841331|183172981|SUPERIORITY||Treatment effect|0.0||||0.4952|TWO_SIDED|95.0|-5.6|5.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||5.7|-5.6|0.4952
91640564|NCT03841331|183172981|SUPERIORITY||Treatment effect|5.2||||0.0891|TWO_SIDED|95.0|-2.3|12.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 4||12.7|-2.3|0.0891
91640565|NCT03841331|183172981|SUPERIORITY||Treatment effect|-4.2||||0.8447|TWO_SIDED|95.0|-12.1|3.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||3.7|-12.1|0.8447
91640566|NCT03841331|183172981|SUPERIORITY||Treatment effect|1.0||||0.4174|TWO_SIDED|95.0|-7.5|9.4|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.4|-7.5|0.4174
91640567|NCT03841331|183172981|SUPERIORITY||Treatment effect|2.7||||0.2756|TWO_SIDED|95.0|-5.8|11.2|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 10||11.2|-5.8|0.2756
91640568|NCT03841331|183172982|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4409|TWO_SIDED|95.0|-0.49|0.57|||ANOVA|||At Week 2||0.57|-0.49|0.4409
91640569|NCT03841331|183172982|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5496|TWO_SIDED|95.0|-0.65|0.57||At week 4|ANOVA|||At Week 4||0.57|-0.65|0.5496
91640570|NCT03841331|183172982|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.6311|TWO_SIDED|95.0|-0.78|0.55|||ANOVA|||At Week 6||0.55|-0.78|0.6311
91640571|NCT03841331|183172982|SUPERIORITY||Mean Difference (Final Values)|0.4738||||0.02|TWO_SIDED|95.0|-0.65|0.69|||ANOVA|||At Week 8||0.69|-0.65|0.02
91640572|NCT03841331|183172982|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3948|TWO_SIDED|95.0|-0.6|0.78|||ANOVA|||At Week 10||0.78|-0.60|0.3948
91640573|NCT03841331|183172984|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.244|TWO_SIDED|95.0|-4.98|9.87|||ANOVA|||At Week 2||9.87|-4.98|0.2440
91673812|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.13||0.1387|TWO_SIDED|95.0|0.55|1.09|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.09|0.55|0.1387
91673813|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.18||0.7275|TWO_SIDED|95.0|0.76|1.48|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.48|0.76|0.7275
91673814|NCT02697773|183241343|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|0.67|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.31|0.67|0.7090
91673815|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.25||0.9164|TWO_SIDED|95.0|0.58|1.62|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.62|0.58|0.9164
91793113|NCT06269484|183463925|OTHER|No test was performed.|Mean Difference (Net)|-11.9|||||TWO_SIDED|90.0|-17.7|-6.1|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-6.1|-17.7|
91640574|NCT03841331|183172984|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.6349|TWO_SIDED|95.0|-9.2|6.65|||ANOVA|||At Week 4||6.65|-9.20|0.6349
91716613|NCT02990000|183324928|SUPERIORITY||condition effect on weekly change rate|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.01|TWO_SIDED|95.0|-0.01|-0.006|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the log-transformed TOP-CS domain-specific z-scores. Given that higher z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.006|-0.01|.01
91716614|NCT02990000|183324929|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.48||0.48|TWO_SIDED||||||Multilevel logistic regression|||Multilevel logistic regression analysis with patients nested within therapists (Scientific Match = 1; Pragmatic Match = 0). Statistically significant odds ratios that are greater than 1 would indicate that patients in the Scientific Match Condition were more likely to discontinue treatment early, whereas odds ratios that are less than 1 would indicate the opposite.||||.48
91640575|NCT03841331|183172984|SUPERIORITY||Mean Difference (Final Values)|0.3407||||1.91|TWO_SIDED|95.0|-6.4|10.23|||ANOVA|||At Week 6||10.23|-6.40|1.91
91640576|NCT03841331|183172984|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.496|TWO_SIDED|95.0|-8.52|8.97|||ANOVA|||At Week 10||8.97|-8.52|0.4960
91640577|NCT02067728|183172994|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Chi-squared|||||||0.0029
91640578|NCT02067728|183172995|SUPERIORITY_OR_OTHER|||||||0.3875|TWO_SIDED||||||t-test, 2 sided|||||||0.3875
91640579|NCT02067728|183172996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91640580|NCT02067728|183172997|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
91640581|NCT02067728|183172998|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||||||1.000
91640582|NCT02067728|183172999|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.2|4.9|||Chi-squared|||||4.9|2.2|<0.0001
91640583|NCT02067728|183173000|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.9|||<|0.0001|TWO_SIDED|95.0|2.0|4.5|||Chi-squared|||||4.5|2.0|<0.0001
91640584|NCT02067728|183173003|SUPERIORITY_OR_OTHER|||||||0.4835|TWO_SIDED||||||t-test, 2 sided|||||||0.4835
91640585|NCT02067728|183173004|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.5880
91640586|NCT04640168|183173008|SUPERIORITY|||||||0.909|||||||Chi-squared|||||||0.909
91640587|NCT04640168|183173025|SUPERIORITY||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|1.8|13.4||||||||13.4|1.8|
91640588|NCT04640168|183173026|SUPERIORITY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-4.3|5.5||||||||5.5|-4.3|
91640589|NCT04640168|183173044|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
91640590|NCT04640168|183173045|SUPERIORITY||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
91640591|NCT04640168|183173046|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
91640592|NCT04640168|183173047|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
91640593|NCT04640168|183173048|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
91640594|NCT03557775|183173074|SUPERIORITY|||||||0.041||||||Result for time by group interaction (threshold for statistical significance set at 0.05).|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.041
91640595|NCT03557775|183173075|SUPERIORITY|||||||0.887||||||Result for time by group interaction. Statistical threshold set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
91640596|NCT03557775|183173076|SUPERIORITY|||||||0.733||||||Result for time by group interaction effect. Threshold for statistical significance was set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.733
91640597|NCT03557775|183173077|SUPERIORITY|||||||0.702||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.702
91640598|NCT03557775|183173078|SUPERIORITY|||||||0.198||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.198
91640599|NCT03557775|183173079|SUPERIORITY|||||||0.388||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.388
91640600|NCT03557775|183173080|SUPERIORITY|||||||0.296||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.296
91640601|NCT03557775|183173081|SUPERIORITY|||||||0.04||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.040
91640602|NCT03557775|183173082|SUPERIORITY|||||||0.887||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
91640603|NCT03557775|183173083|SUPERIORITY|||||||0.663||||||Result for time by group interaction effect. Threshold for statistical significance was set 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.663
91640604|NCT03557775|183173084|SUPERIORITY|||||||0.026||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.026
91640605|NCT03557775|183173085|SUPERIORITY|||||||0.721||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.721
91640606|NCT03557775|183173086|SUPERIORITY|||||||0.408||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.408
91793114|NCT06269484|183463925|OTHER|No test was performed.|Mean Difference (Net)|-2.5|||||TWO_SIDED|90.0|-8.1|3.0|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||3.0|-8.1|
91673816|NCT02697773|183241345|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.2||0.3542|TWO_SIDED|95.0|0.47|1.31|||Negative binomial model|||||1.31|0.47|0.3542
91673817|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.28||0.8065|TWO_SIDED|95.0|0.51|1.68|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.68|0.51|0.8065
91673818|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.2||0.1752|TWO_SIDED|95.0|0.36|1.2|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.20|0.36|0.1752
91673819|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.7837|TWO_SIDED|95.0|0.48|1.73|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.73|0.48|0.7837
91673820|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.26||0.5062|TWO_SIDED|95.0|0.43|1.52|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.52|0.43|0.5062
91673821|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.6821|TWO_SIDED|95.0|0.4|1.82|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.82|0.40|0.6821
91716615|NCT02990000|183324930|SUPERIORITY||condition effect on satisfaction|0.37|STANDARD_ERROR_OF_MEAN|0.48||0.44|TWO_SIDED|95.0|-0.57|1.31|||2-level hierarchical linear model|||Due to the nested nature of the data (patients nested within therapists), we used a two-level hierarchical linear model to test the effect of condition on provider satisfaction at posttreatment. Because higher values indicate more satisfaction, a positive condition effect would indicate that Scientific Match patients were more satisfied than Pragmatic Match patients, whereas a negative condition effect would indicate the opposite.||1.31|-0.57|.44
91485673|NCT02595970|182844481|SUPERIORITY|adjusted|Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-23.52|19.58|||t-test, 2 sided|||||19.58|-23.52|<0.0001
91485674|NCT03089320|182844525|SUPERIORITY||posterior mean proportion of abstinence|9.12|||||TWO_SIDED|95.0|0.08|31.68|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||31.68|0.08|
91485675|NCT03089320|182844526|SUPERIORITY||posterior mean proportion of abstinence|5.5|||||TWO_SIDED|95.0|0.17|18.23|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||18.23|0.17|
91485676|NCT03089320|182844527|SUPERIORITY||Mean Difference (Final Values)|-4.32|STANDARD_ERROR_OF_MEAN|2.84||0.05|TWO_SIDED|95.0|-9.97|1.34|||Mixed Models Analysis|||mixed effects model||1.34|-9.97|.05
91485677|NCT02468232|182844555|SUPERIORITY||Hazard Ratio (HR)|1.0881||||0.626|TWO_SIDED|95.0|0.6501|1.8212|||Regression, Cox|||For Primary Composite||1.8212|0.6501|0.6260
91485678|NCT02468232|182844555|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||For CV Death||2.6122|0.5242|0.6493
91485679|NCT02468232|182844555|SUPERIORITY||Hazard Ratio (HR)|1.2673||||0.7851|TWO_SIDED|95.0|0.7039|2.2818|||Regression, Cox|||For 1st HF Hospitalization||2.2818|0.7039|0.7851
91673822|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.3||0.5032|TWO_SIDED|95.0|0.36|1.65|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.65|0.36|0.5032
91673823|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|1.24|STANDARD_ERROR_OF_MEAN|0.47||0.5796|TWO_SIDED|95.0|0.58|2.61|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.61|0.58|0.5796
91673824|NCT02697773|183241345|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.36||0.8725|TWO_SIDED|95.0|0.44|2.0|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.00|0.44|0.8725
91673825|NCT02756637|183241363|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.98|1.11||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.11|0.98|
91485680|NCT02468232|182844556|SUPERIORITY||LSM of ratio|0.8657||||0.0326|TWO_SIDED|95.0|0.7585|0.988||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 4 analysis||0.9880|0.7585|0.0326
91485681|NCT02468232|182844556|SUPERIORITY||LSM of ratio|0.8538||||0.0161|TWO_SIDED|95.0|0.7509|0.9708||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||0.9708|0.7509|0.0161
91485682|NCT02468232|182844556|SUPERIORITY||LSM of ratio|0.8112||||0.0104|TWO_SIDED|95.0|0.6916|0.9514||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure of ANCOVA model||Month 6 analysis||0.9514|0.6916|0.0104
91485683|NCT02468232|182844558|SUPERIORITY||Hazard Ratio (HR)|1.024||||0.5406|TWO_SIDED|95.0|0.6492|1.6152|||Regression, Cox|||First triple composite endpoint||1.6152|0.6492|0.5406
91485684|NCT02468232|182844558|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||CV health||2.6122|0.5242|0.6493
91485685|NCT02468232|182844558|SUPERIORITY||Hazard Ratio (HR)|0.8546||||0.3448|TWO_SIDED|95.0|0.3952|1.8479|||Regression, Cox|||First worsening of HF in outpatient||1.8479|0.3952|0.3448
91485686|NCT02468232|182844559|SUPERIORITY|||||||0.7115|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 4 analysis||||0.7115
91485687|NCT02468232|182844559|SUPERIORITY|||||||0.1752|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 8 analysis||||0.1752
91673826|NCT02756637|183241363|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.9|1.14||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.14|0.90|
91485688|NCT02468232|182844559|SUPERIORITY|||||||0.2688|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Month 6 analysis||||0.2688
91640607|NCT03557775|183173087|SUPERIORITY|||||||0.638||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.638
91485689|NCT02468232|182844560|SUPERIORITY||LSM of difference|2.5455||||0.1854|TWO_SIDED|95.0|-1.2306|6.3216|||ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||6.3216|-1.2306|0.1854
91485690|NCT02468232|182844560|SUPERIORITY||LSM of difference|1.2695||||0.5737|TWO_SIDED|95.0|-3.1715|5.7104|||ANCOVA|Repeated measure ANCOVA model||Month 6 analysis||5.7104|-3.1715|0.5737
91485691|NCT02468232|182844561|SUPERIORITY||rate ratio|0.8699||||0.6501||95.0|0.4763|1.5887|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.5887|0.4763|0.6501
91485692|NCT02468232|182844562|SUPERIORITY|||||||0.6211|||||||Cochran-Mantel-Haenszel|||||||0.6211
91485693|NCT02468232|182844564|SUPERIORITY||Hazard Ratio (HR)|1.1895||||0.6955|TWO_SIDED|95.0|0.6116|2.3134|||Regression, Cox|||||2.3134|0.6116|0.6955
91640608|NCT03557775|183173088|SUPERIORITY|||||||0.715||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.715
91640609|NCT03557775|183173089|SUPERIORITY|||||||0.708||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.708
91640610|NCT03557775|183173090|SUPERIORITY|||||||0.988||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.988
91640611|NCT00276458|183173093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|2.7|<|0.001||95.0|-25.2|-14.5|||ANCOVA|Model terms: treatment and baseline LDL-C value|(Atorva + EZ minus Atorva)|||-14.5|-25.2|<0.001
91640612|NCT00276458|183173094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|2.1||0.273||95.0|-1.9|6.6|||ANCOVA|Model terms: treatment and baseline HDL-C value|(Atorva + EZ minus Atorva)|||6.6|-1.9|0.273
91640613|NCT00276458|183173095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-21.2|-11.7|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|(Atorva + EZ minus Atorva)|||-11.7|-21.2|<0.001
91640614|NCT00276458|183173096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.8|-8.6|||ANCOVA|Model terms: treatment and baseline Total-C value|(Atorva + EZ minus Atorva)|||-8.6|-15.8|<0.001
91640615|NCT00276458|183173097|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.9||||0.159||95.0|-17.7|-0.4||ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value|Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||-0.4|-17.7|0.159
91640616|NCT00276458|183173098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.1|<|0.001||95.0|-17.8|-9.6|||ANCOVA|Model terms: treatment and baseline Apo B value|(Atorva + EZ minus Atorva)|||-9.6|-17.8|<0.001
91640617|NCT00276458|183173099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.6||0.681||95.0|-3.9|2.6|||ANCOVA|Model terms: treatment and baseline Apo A-I value|(Atorva + EZ minus Atorva)|||2.6|-3.9|0.681
91640618|NCT00276458|183173100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|-17.5|-8.7|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|(Atorva + EZ minus Atorva)|||-8.7|-17.5|<0.001
91640619|NCT00276458|183173101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0|-26.5|-15.3|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-15.3|-26.5|<0.001
91640620|NCT00276458|183173102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-17.9|-8.3|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|(Atorva + EZ minus Atorva)|||-8.3|-17.9|<0.001
91640621|NCT00276458|183173103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0|-23.2|-11.4|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-11.4|-23.2|<0.001
91640622|NCT00276458|183173104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.841||95.0|-23.8|28.8|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment|"Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.~(Atorva + EZ minus Atorva)"|||28.8|-23.8|0.841
91640623|NCT00276458|183173105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.839||95.0|-26.1|8.3|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||8.3|-26.1|0.839
91640624|NCT00276458|183173106|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.6|||<|0.001||95.0|3.8|19.47|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.|||19.47|3.80|<0.001
91640625|NCT04259905|183173107|SUPERIORITY||Cohen's d|0.85|||||TWO_SIDED|||||||||||||
91640626|NCT04259905|183173108|SUPERIORITY||Cohen's d|1.29|||||TWO_SIDED|||||||||||||
91485694|NCT02468232|182844566|SUPERIORITY||Rate ratio|1.0192||||0.9233|TWO_SIDED|95.0|0.6925|1.4999|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.4999|0.6925|0.9233
91485695|NCT02468232|182844567|SUPERIORITY||Rate ratio|1.0754||||0.9272|TWO_SIDED|95.0|0.2264|5.1067|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||5.1067|0.2264|0.9272
91485696|NCT02468232|182844569|SUPERIORITY||Rate ratio|0.4504||||0.0697|TWO_SIDED|95.0|0.1902|1.0665||Negative binomial (NB) regression model|Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.0665|0.1902|0.0697
91640627|NCT04259905|183173109|SUPERIORITY||Cohen's d|1.06|||||TWO_SIDED|||||||||||||
91640628|NCT00634933|183173143|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.||||0.061
91640629|NCT00634933|183173143|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.120
91640630|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.570
91640631|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.200
91640632|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.616
91640633|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.671
91640634|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.108
91640635|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.174
91640636|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.010
91640637|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.029
91640638|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
91640639|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.021
91640640|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.062
91640641|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.049
91640642|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.030
91640643|NCT00634933|183173144|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.005
91640644|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.014
91640645|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.025
91640646|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.794
91640647|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.966|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.966
91640648|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.770
91640649|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.456
91640650|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.880
91640651|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.814
91640652|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.042
91640653|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.035
91640654|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.086
91640655|NCT00634933|183173145|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.082
91640656|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.325
91640657|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.338
91640658|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.983|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.983
91485697|NCT01973569|182844581|SUPERIORITY|||||||0.0235||||||The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.|van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0235
91485698|NCT01973569|182844582|SUPERIORITY|||||||0.036|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0360
91485699|NCT01973569|182844583|SUPERIORITY|||||||0.1323|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.1323
91485700|NCT01973569|182844584|SUPERIORITY|||||||0.0448|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0448
91485701|NCT01973569|182844585|SUPERIORITY|||||||0.0104|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0104
91485702|NCT01973569|182844586|SUPERIORITY|||||||0.257|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.2570
91640659|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.296
91640660|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.575|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.575
91640661|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||1.000
91640662|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.573
91640663|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.563
91640664|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.768
91640665|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.977
91640666|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.249
91640667|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.268
91640668|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.089
91640669|NCT00634933|183173146|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.079
91640670|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.106
91640671|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.322|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.322
91640672|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.059
91640673|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.250
91640674|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.255|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.255
91640675|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.105
91640676|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.001
91640677|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.019
91640678|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.011
91640679|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.113
91640680|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.002
91485703|NCT01973569|182844587|SUPERIORITY||Mean Difference (Net)|5.02|||<|0.0001|TWO_SIDED|95.0|4.41|5.63|||Regression, Cox|ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.||||5.63|4.41|<0.0001
91485704|NCT04612790|182844655|OTHER||Difference in percentage of responders|6.7||||0.509|TWO_SIDED|95.0|-10.9|24.29|||Logistic regression model with Firth adj|||Estimates were from a logistic regression model using the Firth adjustment (adj) that included treatment group, baseline disease severity (moderate, severe) and time of BP diagnosis (participants with newly diagnosed BP, participants with a previous diagnosis of BP who have relapsed) as categorical covariates.||24.29|-10.90|0.509
91485705|NCT00785928|182844661|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is p-value for the fitted ACR50 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.059
91793115|NCT06269484|183463926|OTHER|No test was performed.|Mean Difference (Net)|-6.5|||||TWO_SIDED|90.0|-9.7|-3.4|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-3.4|-9.7|
91640681|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
91640682|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.034
91640683|NCT00634933|183173161|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.003
91640684|NCT00234533|183173177|OTHER|An one-way Analysis of Covariance (ANOVA) was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.9|||||TWO_SIDED|95.0|0.88|0.92|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An Intra-class Correlation Coefficient (ICC) for the evening series (defined as 12:00 to 24:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.92|0.88|
91640685|NCT00234533|183173177|OTHER|An one-way ANOVA was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.92|||||TWO_SIDED|95.0|0.9|0.93|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An ICC for the morning series (defined as 06:00 to 12:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.93|0.90|
91640686|NCT00234533|183173178|OTHER||Fisher's F statistic (F) value|1.79|||||TWO_SIDED|||||||||Analysis of the weekly timing effect (Week 21 versus Week 22 versus Week 23) on the IGF-I value as measured by capillary blood spot method.|For the effect of the weekly timing on the IGF-I levels; F value = 1.79 and the significance probability value, PR\>F = 0.1678.|||
91640687|NCT00234533|183173178|OTHER||F value|1.06|||||TWO_SIDED|||||||||Analysis of the daily timing effect (morning versus evening) on the IGF-I value as measured by capillary blood spot method.|For the effect of the daily timing on the IGF-I levels; F value = 1.06 and the significance probability value, PR\>F = 0.3035|||
91640688|NCT00234533|183173179|OTHER||F value|83.97|||||TWO_SIDED|||||||||Analysis of the effect of the patient's sex (male versus female) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's sex on the IGF-I levels; F value = 83.97 and the significance probability value, PR\>F = \<0.0001.|||
91640689|NCT00234533|183173179|OTHER||F value|68.35|||||TWO_SIDED|||||||||Analysis of the effect of the patient's pubertal status (pubertal versus prepubertal) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's pubertal status on the IGF-I levels; F value = 68.35 and the significance probability value, PR\>F = \<0.0001.|||
91640690|NCT00234533|183173180|OTHER||F value|10.73|||||TWO_SIDED|||||||||Analysis of the disease condition (GHD versus TS) on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 10.73 and the significance probability value, PR\>F = 0.0012.|||
91640691|NCT00234533|183173180|OTHER||F value|2.2|||||TWO_SIDED|||||||||Analysis of the country cluster on the IGF-I value as measured by capillary blood spot method.|For the effect of the country cluster on the IGF-I levels; F value = 2.20 and the significance probability value, PR\>F = 0.0701.|||
91640692|NCT00234533|183173181|OTHER||F value|3.65|||||TWO_SIDED|||||||||Analysis of the time of the year on the IGF-I value as measured by capillary blood spot method.|For the effect of the time of the year on the IGF-I levels; F value = 3.65 and the significance probability value, PR\>F = 0.0139.|||
91640693|NCT00234533|183173181|OTHER||F value|7.38|||||TWO_SIDED|||||||||Analysis of the effect of the calculated age at enrolment on the IGF-I value as measured by capillary blood spot method.|For the effect of the calculated age at enrolment on the IGF-I levels; F value = 7.38 and the significance probability value, PR\>F = 0.0073.|||
91640694|NCT00234533|183173181|OTHER||F value|3.86|||||TWO_SIDED|||||||||Analysis of the effect of the disease condition on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 3.86 and the significance probability value, PR\>F = 0.0511|||
91640695|NCT00234533|183173182|OTHER||Mean difference|-164.79|STANDARD_ERROR_OF_MEAN|159.28|||TWO_SIDED|95.0|-483.35|-153.77||||||The Bland and Altman method was used to compare the results of each of the three simultaneous random capillary and serum measurements were compared. The difference between the capillary blood spot method and the serum IGF-I measurements is presented||-153.77|-483.35|
91640696|NCT00570492|183173196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.48|-0.06|||||An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.|||-0.06|-0.48|
91640697|NCT00908375|183173225|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.|Median Difference (Final Values)|-2.0||||0.279|TWO_SIDED|99.0|-6.0|3.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||3|-6|0.279
91640698|NCT00908375|183173226|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.282|TWO_SIDED|99.0|-2.0|1.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||1.0|-2.0|0.282
91640699|NCT00908375|183173227|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-16.0||||0.139|TWO_SIDED|99.0|-42.0|16.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||16|-42|0.139
91640700|NCT02279888|183173243|OTHER|the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80%|Kaplan Meier|0.05|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91640701|NCT02279888|183173245|OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.39|0.47|||Andersen-Gill||This analysis applies to Primary Outcome: HFH Rate|||0.47|0.39|<0.0001
91640702|NCT02279888|183173247|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.52|0.62|||Andersen-Gill|||||0.62|0.52|<0.0001
91640703|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|3.04||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.32
91640704|NCT01484691|183173259|SUPERIORITY||Mean Difference (Final Values)|1.91||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.38
91640705|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|0.47||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.83
91640706|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|1.27||||0.42|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.42
91640707|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|2.55||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.32
91640708|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|0.68||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.83
91640709|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|1.94||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.38
91640710|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|2.77||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.38
91640711|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|3.38||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.32
91640712|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.99
91640713|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|1.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.38
91640714|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|1.57||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.38
91640715|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|0.52||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.83
91640716|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|0.81||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.83
91640717|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|1.39||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.38
91673827|NCT03660241|183241374|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|138.49|||||TWO_SIDED|90.0|93.74|204.61|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group.||204.61|93.74|
91640718|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|-0.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.38
91640719|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|0.55||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.83
91640720|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|-1.12||||0.3|TWO_SIDED||||||t-test, 2 sided|||mir1915||||0.30
91640721|NCT01484691|183173259|SUPERIORITY||Mean Difference (Net)|-1.35||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.38
91640722|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|4.53||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.26
91640723|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|4.52||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.26
91640724|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|3.57||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.26
91673828|NCT03660241|183241374|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.11|||||TWO_SIDED|90.0|57.3|171.43|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||171.43|57.30|
91526476|NCT03573908|182928119|SUPERIORITY||Least squares (LS) mean difference|-0.715|||<|0.0001|TWO_SIDED|95.0|-0.998|-0.433|||MMRM||Least squares (LS) mean difference (linaclotide - placebo)|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.433|-0.998|< 0.0001
91673829|NCT03660241|183241375|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|182.91|||||TWO_SIDED|90.0|117.09|285.71|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.71|117.09|
91673830|NCT03660241|183241375|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|121.32|||||TWO_SIDED|90.0|68.32|215.41|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||215.41|68.32|
91673831|NCT03660241|183241376|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.51|||||TWO_SIDED|90.0|59.8|165.57|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||165.57|59.80|
91673832|NCT03660241|183241376|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|167.79|||||TWO_SIDED|90.0|97.2|289.64|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||289.64|97.20|
91673833|NCT03660241|183241377|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|154.22|||||TWO_SIDED|90.0|105.11|226.26|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||226.26|105.11|
91673834|NCT03660241|183241377|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|287.06|||||TWO_SIDED|90.0|196.72|418.89|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||418.89|196.72|
91673835|NCT03660241|183241378|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|137.43|||||TWO_SIDED|90.0|106.82|176.81|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||176.81|106.82|
91673836|NCT03660241|183241378|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|177.92|||||TWO_SIDED|90.0|135.91|232.92|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||232.92|135.91|
91673837|NCT03660241|183241379|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|269.78|||||TWO_SIDED|90.0|196.61|370.18|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||370.18|196.61|
91673838|NCT03660241|183241379|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|571.43|||||TWO_SIDED|90.0|447.27|730.05|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||730.05|447.27|
91673839|NCT03660241|183241384|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|133.87|||||TWO_SIDED|90.0|102.45|174.92|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||174.92|102.45|
91673840|NCT03660241|183241384|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|129.49|||||TWO_SIDED|90.0|92.86|180.57|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||180.57|92.86|
91673841|NCT03660241|183241385|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|210.2|||||TWO_SIDED|90.0|154.6|285.8|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.80|154.60|
91673842|NCT03660241|183241385|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|290.68|||||TWO_SIDED|90.0|217.39|388.69|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||388.69|217.39|
91673843|NCT03919448|183241392|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|101.55||||0.9766|TWO_SIDED|90.0|90.19|114.34||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.34|90.19|0.9766
91673844|NCT03919448|183241392|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.95||||0.9766|TWO_SIDED|90.0|89.75|113.55||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||113.55|89.75|0.9766
91673845|NCT03919448|183241392|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.59||||0.9766|TWO_SIDED|90.0|88.16|114.77|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.77|88.16|0.9766
91673846|NCT03919448|183241393|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.82||||0.3617|TWO_SIDED|90.0|81.21|101.57||Power of ANOVA: 0,95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.57|81.21|0.3617
91793116|NCT06269484|183463926|OTHER|No test was performed.|Mean Difference (Net)|-10.8|||||TWO_SIDED|90.0|-14.1|-7.6|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-7.6|-14.1|
91485706|NCT00785928|182844661|SUPERIORITY_OR_OTHER||ED95|119.0||||0.042||95.0||||This is the p-value for the estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is ED95 in mg.||||||0.042
91716616|NCT01949545|183324941|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|144.43||||0.02232|TWO_SIDED|95.0|111.48|187.12|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an analysis of variance (ANOVA) of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||187.12|111.48|0.02232
91485707|NCT00785928|182844662|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||This is the p-value for the fitted ACR20 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.044
91640725|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|-0.58||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.87
91640726|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|4.57||||0.29|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.29
91640727|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|1.56||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.75
91640728|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|2.9||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.36
91640729|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|-0.36||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.89
91640730|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|2.48||||0.48|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.48
91640731|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|0.75||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.87
91640732|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|2.78||||0.53|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.53
91640733|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|1.91||||0.57|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.57
91640734|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|4.27||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.26
91640735|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|1.66||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.75
91640736|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|-0.91||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.89
91640737|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|3.32||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.26
91640738|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|-0.99||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.87
91640739|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|-0.75||||0.74|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1915||||0.74
91640740|NCT01484691|183173260|SUPERIORITY||Mean Difference (Net)|3.77||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.36
91640741|NCT03522506|183173261|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The least squares mean (LSM) sleep latency for each treatment and the associated standard error and 95% confidence interval (CI) was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|Least square mean difference|20.06|||<|0.001|TWO_SIDED|95.0|13.35|26.77|||Linear mixed effect model|||||26.77|13.35|<0.001
91640742|NCT03522506|183173261|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|24.35|||<|0.001|TWO_SIDED|95.0|17.64|31.06|||Linear mixed effect model|||||31.06|17.64|<0.001
91640743|NCT03522506|183173261|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM Difference|19.89|||<|0.001|TWO_SIDED|95.0|13.3|26.49|||Linear mixed effects model|||||26.49|13.30|<0.001
91640744|NCT03522506|183173271|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.2||||0.664|TWO_SIDED|95.0|-1.13|0.73|||Linear mixed effect model|||||0.73|-1.13|0.664
91640745|NCT03522506|183173271|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.24||||0.605|TWO_SIDED|95.0|-0.69|1.17|||Linear mixed effect model|||||1.17|-0.69|0.605
91640746|NCT03522506|183173271|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.574|TWO_SIDED|95.0|-1.17|0.66|||Linear mixed effect model|||||0.66|-1.17|0.574
91640747|NCT03522506|183173271|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.29||||0.483|TWO_SIDED|95.0|-0.53|1.11|||Linear mixed effect model|||||1.11|-0.53|0.483
91640748|NCT03522506|183173271|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.01||||0.972|TWO_SIDED|95.0|-0.81|0.84|||Linear mixed effect model|||||0.84|-0.81|0.972
91640749|NCT03522506|183173271|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.18||||0.654|TWO_SIDED|95.0|-0.99|0.63|||Linear mixed effect model|||||0.63|-0.99|0.654
91640750|NCT03522506|183173271|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.01||||0.984|TWO_SIDED|95.0|-0.86|0.85|||Linear mixed effect model|||||0.85|-0.86|0.984
91640751|NCT03522506|183173271|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.29||||0.508|TWO_SIDED|95.0|-1.14|0.57|||Linear mixed effect model|||||0.57|-1.14|0.508
91640752|NCT03522506|183173271|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.22||||0.605|TWO_SIDED|95.0|-1.06|0.62|||Linear mixed effect model|||||0.62|-1.06|0.605
91673847|NCT03919448|183241393|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|94.87||||0.3617|TWO_SIDED|90.0|84.91|105.99||Power of ANOVA: 0.95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||105.99|84.91|0.3617
91716617|NCT01949545|183324941|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|126.08||||0.1812|TWO_SIDED|95.0|94.59|168.06|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||168.06|94.59|0.1812
91640753|NCT03522506|183173271|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.11||||0.847|TWO_SIDED|95.0|-1.06|1.29|||Linear mixed effect model|||||1.29|-1.06|0.847
91640754|NCT03522506|183173271|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.44||||0.455|TWO_SIDED|95.0|-1.61|0.73|||Linear mixed effect model|||||0.73|-1.61|0.455
91640755|NCT03522506|183173271|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.58||||0.317|TWO_SIDED|95.0|-1.74|0.57|||Linear mixed effect model|||||0.57|-1.74|0.317
91673848|NCT03919448|183241393|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.73||||0.3617|TWO_SIDED|90.0|84.82|108.05|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||108.05|84.82|0.3617
91673849|NCT03919448|183241394|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.46||||0.3529|TWO_SIDED|90.0|80.64|101.47||Power of ANOVA: 0.94|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.47|80.64|0.3529
91673850|NCT03919448|183241394|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|95.02||||0.3529|TWO_SIDED|90.0|84.8|106.49||Power of ANOVA: 0.94|ANOVA|||||106.49|84.80|0.3529
91793117|NCT06269484|183463926|OTHER|No test was performed.|Mean Difference (Net)|-4.3|||||TWO_SIDED|90.0|-7.4|-1.1|||Mixed Models Analysis|Comparisons are done as Zibo adjusted Zibo/Dapa, Placebo adjusted Zibo/Dapa or Placebo adjusted Zibo.||||-1.1|-7.4|
91640756|NCT03522506|183173271|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.0||||0.001|TWO_SIDED|95.0|-3.18|-0.83|||Linear mixed effect model|||||-0.83|-3.18|0.001
91640757|NCT03522506|183173271|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.61|||<|0.001|TWO_SIDED|95.0|-4.79|-2.44|||Linear mixed effect model|||||-2.44|-4.79|<0.001
91640758|NCT03522506|183173271|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.16|||<|0.001|TWO_SIDED|95.0|-4.32|-2.01|||Linear mixed effect model|||||-2.01|-4.32|<0.001
91640759|NCT03522506|183173271|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.69||||0.003|TWO_SIDED|95.0|-2.78|-0.6|||Linear mixed effect model|||||-0.60|-2.78|0.003
91640760|NCT03522506|183173271|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-4.3|||<|0.001|TWO_SIDED|95.0|-5.39|-3.21|||Linear mixed effect model|||||-3.21|-5.39|<0.001
91640761|NCT03522506|183173271|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.83|||<|0.001|TWO_SIDED|95.0|-4.91|-2.76|||Linear mixed effect model|||||-2.76|-4.91|<0.001
91640762|NCT03522506|183173271|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.71||||0.13|TWO_SIDED|95.0|-1.63|0.21|||Linear mixed effect model|||||0.21|-1.63|0.130
91640763|NCT03522506|183173271|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.24|-2.4|||Linear mixed effect model|||||-2.40|-4.24|<0.001
91673851|NCT03919448|183241394|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.19||||0.3529|TWO_SIDED|90.0|84.17|107.67|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||107.67|84.17|0.3529
91673852|NCT01567826|183241409|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||||||0.01
91673853|NCT01567826|183241410|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
91673854|NCT01612884|183241417|OTHER|Student's T-test||||||0.85|||||||t-test, 2 sided|||||||0.85
91640764|NCT03522506|183173271|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.62|-1.8|||Linear mixed effect model|||||-1.80|-3.62|<0.001
91673855|NCT01612884|183241418|OTHER|Chi-Square||||||0.93|||||||Chi-squared|||||||0.93
91793118|NCT05411367|183463930|SUPERIORITY||Mean Difference (Net)|-0.12||||0.315|TWO_SIDED|95.0|-0.62|0.38|||ANCOVA|||||0.38|-0.62|0.315
91485708|NCT00785928|182844662|SUPERIORITY_OR_OTHER||ED95|118.5||||0.005||95.0||||This p-value is for estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) of the ACR20 and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is the ED95 in mg.||||||0.005
91673856|NCT01612884|183241419|OTHER|Chi-Square|||||>|0.05|||||||Chi-squared|||||||>0.05
91673857|NCT03265288|183241420|SUPERIORITY||Least square means difference|0.7716||||0.3449|TWO_SIDED|95.0|-0.8397|2.3828||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Primary analysis of the treatment effect at the Week 24 visit on the intent to treat population (ITT) Null hypothesis is no treatment difference||2.3828|-0.8397|0.3449
91673858|NCT03265288|183241420|SUPERIORITY||Least square means difference|1.0053||||0.0667|TWO_SIDED|95.0|-0.07|2.0807||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Analysis of the overall treatment effect from baseline through Week 24 in the intent to treat population (ITT), Null hypothesis is no treatment difference||2.0807|-0.0700|0.0667
91673859|NCT03265288|183241420|SUPERIORITY||Least square means difference|1.2258||||0.0486|TWO_SIDED|95.0|0.0078|2.4438||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Secondary analysis of the overall treatment effect from baseline through Week 24 on the per protocol population (PP), null hypothesis is no treatment difference||2.4438|0.0078|0.0486
91673860|NCT03265288|183241420|SUPERIORITY||Least square means difference|2.6628||||0.0687|TWO_SIDED|95.0|-0.2069|5.5325||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor ppFEV1 (\<70% or ≥70%) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup ≥70%, n=29 (LAU-7b), n=27 (Placebo)"||5.5325|-0.2069|0.0687
91673861|NCT03265288|183241420|SUPERIORITY||Least square means difference|1.391||||0.236|TWO_SIDED|95.0|-0.922|3.7041||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor co-administration of CFTR modulator (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving CFTR modulators, n=41 (LAU-7b), n=46 (Placebo)"||3.7041|-0.9220|0.236
91716618|NCT01949545|183324942|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|151.84||||0.02137|TWO_SIDED|95.0|113.59|202.96|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||202.96|113.59|0.02137
91485709|NCT00785928|182844663|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.623
91673862|NCT03265288|183241420|SUPERIORITY||Least square means difference|1.1302||||0.5323|TWO_SIDED|95.0|-2.4447|4.7052||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for à priori defined subgroup co-administration of ETI - elexacaftor/tezacaftor/ivacaftor (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving ETI, n=18 (LAU-7b), n=23 (Placebo)"||4.7052|-2.4447|0.5323
91673863|NCT03265288|183241422|SUPERIORITY||Odds Ratio (OR)|0.5036||||0.1047|TWO_SIDED|95.0|0.2199|1.1532||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Arachidonic Acid (AA) during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||1.1532|0.2199|0.1047
91673864|NCT03265288|183241422|SUPERIORITY||Odds Ratio (OR)|0.8773||||0.7596|TWO_SIDED|95.0|0.3793|2.0291||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Docosahexaenoic Acid (DHA) during treatment Intent to treat population (ITT, null hypothesis is no treatment effect||2.0291|0.3793|0.7596
91673865|NCT03265288|183241422|SUPERIORITY||Odds Ratio (OR)|1.0532||||0.8852|TWO_SIDED|95.0|0.5209|2.1296||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of AA/DHA ratio during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||2.1296|0.5209|0.8852
91673866|NCT03265288|183241425|SUPERIORITY|||||||0.3025|||||||Log Rank|||||||0.3025
91673867|NCT03265288|183241426|SUPERIORITY||Risk Ratio (RR)|1.55||||0.3366|TWO_SIDED|95.0|0.63|3.8||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Protocol-Defined IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||3.80|0.63|0.3366
91673868|NCT03265288|183241426|OTHER||Risk Ratio (RR)|1.34||||0.3936|TWO_SIDED|95.0|0.68|2.64||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|ALL IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||2.64|0.68|0.3936
91793119|NCT05411367|183463931|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.487|TWO_SIDED|95.0|-0.11|0.11|||Mixed Models Analysis|||||0.11|-0.11|0.487
91716619|NCT01949545|183324942|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|143.53||||0.07247|TWO_SIDED|95.0|103.28|199.45|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||199.45|103.28|0.07247
91716620|NCT03268343|183324983|SUPERIORITY||Geometric LS Mean Ratio (%)|74.71|||||TWO_SIDED|90.0|66.39|84.08|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||84.08|66.39|
91716621|NCT03268343|183324984|SUPERIORITY||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|94.2|99.98|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.98|94.20|
91716622|NCT03268343|183324985|SUPERIORITY||Median Difference (Final Values)|1.38|||<|0.0001|TWO_SIDED|95.0|0.5|2.25|||Wilcoxon Signed-Rank test||Hodges-Lehmann method|||2.25|0.50|< 0.0001
91716623|NCT03268343|183324986|SUPERIORITY||Geometric LS Mean Ratio (%)|96.52|||||TWO_SIDED|90.0|93.3|99.85|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.85|93.30|
91716624|NCT03268343|183324990|SUPERIORITY||Geometric LS Mean Ratio (%)|104.75|||||TWO_SIDED|95.0|98.97|110.87|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||110.87|98.97|
91716625|NCT01507181|183325041|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
91640765|NCT03522506|183173271|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.577|TWO_SIDED|95.0|-1.2|0.68|||Linear mixed effect model|||||0.68|-1.20|0.577
91716626|NCT01507181|183325042|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
91716627|NCT01507181|183325043|SUPERIORITY_OR_OTHER|||||||0.17||||||Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.|ANCOVA|||||||0.17
91716628|NCT01669434|183325053|SUPERIORITY||Risk Ratio (RR)|0.81||||0.03|TWO_SIDED|95.0|0.67|0.97|||Fisher Exact|||||0.97|0.67|0.03
91716629|NCT01669434|183325054|SUPERIORITY||Risk Ratio (RR)|0.6||||0.44|TWO_SIDED|95.0|0.23|1.6|||Fisher Exact|||||1.60|0.23|0.44
91716630|NCT01669434|183325055|SUPERIORITY||Risk Ratio (RR)|1.2||||1|TWO_SIDED|95.0|0.48|2.99|||Fisher Exact|||||2.99|0.48|1.0
91716631|NCT01669434|183325056|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.81|1.26|||Fisher Exact|||||1.26|0.81|1.0
91716632|NCT01669434|183325057|SUPERIORITY||Risk Ratio (RR)|1.95||||0.01|TWO_SIDED|95.0|1.14|3.34|||Fisher Exact|||||3.34|1.14|0.01
91716633|NCT01669434|183325058|SUPERIORITY||Risk Ratio (RR)|0.49||||0.02|TWO_SIDED|95.0|0.28|0.86|||Fisher Exact|||||0.86|0.28|0.02
91716634|NCT02860988|183325059|OTHER|Two-sided tests versus a margin|Mean Difference (Net)|0.6||||0.29|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.29
91716635|NCT02860988|183325060|OTHER|Two-sided tests versus a margin|Risk Difference (RD)|0.9||||0.88|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.88
91716636|NCT02860988|183325061|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|0.96||||0.89|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.89
91716637|NCT02860988|183325062|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|-4.26||||0.61|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.61
91716638|NCT02860988|183325063|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|3.61||||0.67|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.67
91716639|NCT02860988|183325064|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|5.23||||0.14|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.14
91716640|NCT02860988|183325065|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.03||||0.81|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.81
91716641|NCT02860988|183325066|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.31||||0.74|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.74
91716642|NCT00526474|183325135|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.001|TWO_SIDED|95.0|0.82|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.82|0.001
91716643|NCT00526474|183325136|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.80|<0.001
91716644|NCT00526474|183325137|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.74|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.74|1.31|<0.001
91716645|NCT00526474|183325138|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.31|1.51|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.51|1.31|<0.001
91673869|NCT03265288|183241426|SUPERIORITY||Risk Ratio (RR)|1.16||||0.5011|TWO_SIDED|95.0|0.75|1.79||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Combined IV- or Oral antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||1.79|0.75|0.5011
91673870|NCT03265288|183241427|SUPERIORITY|||||||0.1955|||||||Log Rank|||||||0.1955
91640766|NCT03522506|183173271|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.26|||<|0.001|TWO_SIDED|95.0|-3.2|-1.32|||Linear mixed effect model|||||-1.32|-3.20|<0.001
91640767|NCT03522506|183173271|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.57|-0.72|||Linear mixed effect model|||||-0.72|-2.57|<0.001
91640768|NCT03522506|183173271|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.31||||0.475|TWO_SIDED|95.0|-0.55|1.16|||Linear mixed effect model|||||1.16|-0.55|0.475
91640769|NCT03522506|183173271|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.14||||0.753|TWO_SIDED|95.0|-0.99|0.72|||Linear mixed effect model|||||0.72|-0.99|0.753
91640770|NCT03522506|183173271|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.99||||0.022|TWO_SIDED|95.0|-1.83|-0.15|||Linear mixed effect model|||||-0.15|-1.83|0.022
91640771|NCT03522506|183173272|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|22.94|||<|0.001|TWO_SIDED|95.0|16.58|29.3|||Linear mixed effect model|||||29.30|16.58|<0.001
91640772|NCT03522506|183173272|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|30.95|||<|0.001|TWO_SIDED|95.0|24.59|37.31|||Linear mixed effects model|||||37.31|24.59|<0.001
91640773|NCT03522506|183173272|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|26.5|||<|0.001|TWO_SIDED|95.0|20.24|32.75|||Linear mixed effect model|||||32.75|20.24|<0.001
91640774|NCT03522506|183173273|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|14.56|||<|0.001|TWO_SIDED|95.0|7.04|22.08|||Linear mixed effect model|||||22.08|7.04|<0.001
91640775|NCT03522506|183173273|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|32.21|||<|0.001|TWO_SIDED|95.0|24.68|39.73|||Linear mixed effect model|||||39.73|24.68|<0.001
91640776|NCT03522506|183173273|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|25.74|||<|0.001|TWO_SIDED|95.0|18.33|33.14|||Linear mixed effect model|||||33.14|18.33|<0.001
91673871|NCT03265288|183241428|SUPERIORITY||Risk Ratio (RR)|1.35||||0.1909|TWO_SIDED|95.0|0.86|2.12||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds of an antibiotic treatment with LAU-7b, odds ratio \> 1 means higher odds of an antibiotic treatment with LAU-7b|Number per subject of intravenous antibiotic treatments required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations Intent to treat population (ITT), null hypothesis is no treatment effect||2.12|0.86|0.1909
91673872|NCT03265288|183241429|SUPERIORITY||Risk Ratio (RR)|1.11||||0.7473|TWO_SIDED|95.0|0.6|2.04||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds in terms of days of antibiotics with LAU-7b, odds ratio close to 1 means similar odds in terms of days of antibiotics with LAU-7b or placebo, odds ratio \> 1 means higher odds in terms of days of antibiotics with LAU-7b|Number of days of intravenous antibiotics required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations, Intent to treat population (ITT), null hypothesis is no treatment effect||2.04|0.60|0.7473
91485710|NCT00785928|182844663|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.160
91640777|NCT03522506|183173274|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|9.6||||0.003|TWO_SIDED|95.0|3.35|15.85|||Linear mixed effect model|||||15.85|3.35|0.003
91640778|NCT03522506|183173274|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|33.33|||<|0.001|TWO_SIDED|95.0|27.08|39.58|||Linear mixed effect model|||||39.58|27.08|<0.001
91640779|NCT03522506|183173274|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.91|||<|0.001|TWO_SIDED|95.0|10.77|23.06|||Linear mixed effect model|||||23.06|10.77|<0.001
91640780|NCT03522506|183173275|SUPERIORITY|An analysis of variance (ANOVA) model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.16||||0.436|TWO_SIDED|95.0|-7.68|3.36|||ANOVA|||||3.36|-7.68|0.436
91640781|NCT03522506|183173275|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.29||||0.409|TWO_SIDED|95.0|-7.81|3.23|||ANOVA|||||3.23|-7.81|0.409
91640782|NCT03522506|183173275|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.77|||<|0.001|TWO_SIDED|95.0|11.37|22.18|||ANOVA|||||22.18|11.37|<0.001
91673873|NCT03265288|183241430|SUPERIORITY||Least Squares Means difference|-2.89||||0.0822|TWO_SIDED|95.0|-6.154|0.374||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Intent-to-Treat population (ITT), null hypothesis is no treatment effect||0.374|-6.154|0.0822
91673874|NCT03265288|183241430|SUPERIORITY||Least Squares Means difference|-576.0||||0.0603|TWO_SIDED|95.0|-1177.0|25.4||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Intent-to-Treat population (ITT), null hypothesis is no treatment effect||25.4|-1177|0.0603
91673875|NCT03265288|183241430|SUPERIORITY||Least Square Means difference|-3.853||||0.0287|TWO_SIDED|95.0|-7.297|-0.408||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Per-Protocol population (PP), null hypothesis is no treatment effect||-0.408|-7.297|0.0287
91673876|NCT03265288|183241430|SUPERIORITY||Least Square Means difference|-620.0||||0.0459|TWO_SIDED|95.0|-1228.0|12.0||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Per-Protocol population (PP), null hypothesis is no treatment effect||12|-1228|0.0459
91673877|NCT03265288|183241431|SUPERIORITY||Least Squares Means difference|-0.39||||0.1006|TWO_SIDED|95.0|-0.86|0.08||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body weight, Intent to treat population (ITT), null hypothesis is no treatment effect||0.08|-0.86|0.1006
91673878|NCT03265288|183241432|SUPERIORITY||Least Squares Means difference|-0.137||||0.1246|TWO_SIDED|95.0|-0.312|0.038||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body mass index, intent to treat population (ITT), null hypothesis is no treatment effect||0.038|-0.312|0.1246
91673879|NCT03265288|183241433|SUPERIORITY|||||||0.764||||||alpha is set to 0.05|ANOVA|||Intent to treat population (ITT), null hypothesis is no treatment effect||||0.7640
91673880|NCT03265288|183241434|SUPERIORITY||Least Squares Means difference|-2.758||||0.2996|TWO_SIDED|95.0|-7.998|2.482||alpha is set to 0.05|Mixed Model for Repeated Measures|||CFQ-R Respiratory subscore, intent to treat population (ITT), null hypothesis is no treatment effect||2.482|-7.998|0.2996
91673881|NCT02790034|183241439|SUPERIORITY||Mean Difference (Final Values)|-5.292|STANDARD_ERROR_OF_MEAN|11.3184||0.6411|TWO_SIDED|95.0|-27.741|17.157|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||17.157|-27.741|0.6411
91692154|NCT00720213|183279263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|8.03||0.0054|TWO_SIDED|95.0|1.44|6.51|||Wilcoxon Signed Rank test|||Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.||6.51|1.44|0.0054
91673882|NCT02790034|183241439|SUPERIORITY||Mean Difference (Final Values)|-16.966|STANDARD_ERROR_OF_MEAN|13.1869||0.2011|TWO_SIDED|95.0|-43.119|9.186|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||9.186|-43.119|0.2011
91673883|NCT04976621|183241465|OTHER|Because this was a feasibility study, we did not compute inferential statistics and did not include a power calculation.||||||||||||Because this was a feasibility study, inferential statistics were not computed.||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
91673884|NCT04976621|183241466|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
91673885|NCT04976621|183241467|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
91673886|NCT04976621|183241468|OTHER||||||||||||||||||Descriptive statistics are being used.|||
91673887|NCT04976621|183241469|OTHER|||||||||||||||||Descriptive statistics are used to describe acceptability/satisfaction for those who received the BA intervention. This tool is completed after the last intervention session when the qualitative interview is also conducted.|Descriptive statistics are used in this feasibility study. We are not using inferential statistics to test for statistical significance.|||
91673888|NCT04976621|183241470|OTHER||||||||||||||||||Descriptive statistics are used to describe recruitment.|||
91673889|NCT04976621|183241471|OTHER||||||||||||||||||One measure of retention was the percent in each group who completed the study, meaning completed the Time 2 follow-up interview (that occurred 3-4 months after the baseline interview). Another measure of retention was the percent in the treatment group that completed four or more treatment sessions.|||
91673890|NCT04976621|183241472|OTHER||||||||||||||||||For each of five participants who received the intervention, we reviewed a transcript of 1 intervention session for treatment fidelity. The criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.|||
91673891|NCT05611996|183241484|SUPERIORITY||Mean Difference (Net)|-1.783|STANDARD_ERROR_OF_MEAN|0.772||0.025|TWO_SIDED|95.0|-3.336|-0.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.||-0.230|-3.336|0.025
91673892|NCT05611996|183241484|SUPERIORITY||Mean Difference (Net)|-2.42|STANDARD_ERROR_OF_MEAN|0.814||0.005|TWO_SIDED|95.0|-4.057|-0.784||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.||-0.784|-4.057|0.005
91673893|NCT05611996|183241484|SUPERIORITY||Mean Difference (Net)|-0.5468|STANDARD_ERROR_OF_MEAN|0.1744||0.004|TWO_SIDED|95.0|-0.9039|-0.1897||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||The mean difference of the PHQ-9 score by each unit increase of the time(each week increase)|Null hypothesis: There is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores over time for all study participants.||-0.1897|-0.9039|0.0040
91673894|NCT03053583|183241485|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||Posthoc analysis of POGO scores were compared using the Kruskall Wallis test with Mann-WHitney test for pairwise comparisons||||<0.05
91673895|NCT04479475|183241497|OTHER|The Wilcoxon signed-rank test is a non-parametric statistical test. We used it to assess repeated measures of missed methadone doses.|Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|10.8||0.0094|TWO_SIDED|||||Exact p-value reported due to small sample size|Wilcoxon signed-rank test||We opted not to include the 95% confidence interval due to the non-parametric nature of the data.|||||0.0094
91673896|NCT05363683|183241499|SUPERIORITY|||||||0.293|||||||ANCOVA|||||||0.293
91673897|NCT05363683|183241501|SUPERIORITY|||||||0.114|||||||ANCOVA|||||||0.114
91673898|NCT05363683|183241502|SUPERIORITY|||||||0.017|||||||ANCOVA|||||||0.017
91673899|NCT05363683|183241503|SUPERIORITY|||||||0.021|||||||ANCOVA|||||||0.021
91673900|NCT05363683|183241504|SUPERIORITY|||||||0.936|||||||Wilcoxon (Mann-Whitney)|||||||0.936
91673901|NCT05363683|183241505|SUPERIORITY|||||||0.867|||||||Wilcoxon (Mann-Whitney)|||||||0.867
91673902|NCT05363683|183241506|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.370
91673903|NCT05363683|183241507|SUPERIORITY|||||||0.379|||||||Wilcoxon (Mann-Whitney)|||||||0.379
91673904|NCT00619359|183241508|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.|Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|3.7||||95.0|-4.1|3.3||||||||3.3|-4.1|
91673905|NCT00619359|183241509|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.|Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-3.5|3.7||||||||3.7|-3.5|
91673906|NCT00619359|183241510|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.|Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-5.3|2.0||||||||2.0|-5.3|
91673907|NCT05575063|183241517|NON_INFERIORITY|All analyzed numbers are in percentage. The success criterion for the primary safety endpoint was met (Safety Population), as the investigational device (HEALON EndoCoat OVD) demonstrated non-inferiority to the control device (HEALON EndoCoat OVD) with respect to the difference in IOP spike rate, estimated to be 0.08% (with the 95% confidence interval of \[-5.07%; 5.23%\]).|Not Measured|0.08|STANDARD_ERROR_OF_MEAN|2.63|||TWO_SIDED|95.0|-5.07|5.23|||Mixed Models Analysis||All values in this section are in percentage.|||5.23|-5.07|
91673908|NCT05575063|183241518|NON_INFERIORITY|All analyzed numbers are in percentage. The success criterion for the primary effectiveness endpoint was met (modified ITT Population) as the investigational device (HEALON EndoCoat OVD) demonstrated non-inferiority to the control device (HEALON EndoCoat OVD) with respect to the difference in mean ECC percent change, estimated to be -0.50% (with the 95% confidence interval of \[-3.37%; 2.37%\]).|Difference in Percent Change|-0.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-3.37|2.37|||Mixed Models Analysis||All values are in percentage.|||2.37|-3.37|
91485711|NCT00785928|182844663|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.568
91673909|NCT04625062|183241527|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.72|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Traditional treatment condition - biofeedback treatment condition|||||.72
91673910|NCT02654587|183241528|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.05|TWO_SIDED|95.0|0.38|0.91||OS in patients with ICI secondary resistance|t-test, 2 sided||p=0.017|||0.91|0.38|<0.05
91673911|NCT02654587|183241528|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.36|TWO_SIDED|95.0|0.62|1.19|||t-test, 2 sided|||OS in the ITT population with ICI resistance (primary and secondary resistance)||1.19|0.62|0.36
91673912|NCT02654587|183241529|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.004|TWO_SIDED|95.0|0.27|0.79|||t-test, 2 sided|||Post-progression survival in patients with ICI secondary resistance||0.79|0.27|0.004
91673913|NCT02654587|183241529|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0035|TWO_SIDED|95.0|0.39|0.83|||t-test, 2 sided|||Post-progression survival in ITT population with ICI resistance (primary and secondary)||0.83|0.39|0.0035
91673914|NCT02654587|183241530|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.006|TWO_SIDED|95.0|0.23|0.8|||t-test, 2 sided|||Time to worsening ECOG PS \>1 in patients with ICI secondary resistance||0.80|0.23|0.006
91673915|NCT02654587|183241530|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.02|TWO_SIDED|95.0|0.35|0.92|||t-test, 2 sided|||Time to worsening ECOG PS in the ITT population with ICI resistance (primary and secondary)||0.92|0.35|0.02
91673916|NCT02654587|183241531|SUPERIORITY||P Value|0.045|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ C30 Global Health Status in Patients with ICI secondary resistance||||<0.05
91673917|NCT02654587|183241531|SUPERIORITY||P Value|0.07||||0.07|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Physical functioning in patients with ICI secondary resistance||||0.07
91673918|NCT02654587|183241531|SUPERIORITY||P Value|0.03|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Role functioning in patients with ICI secondary resistance||||<0.05
91673919|NCT02654587|183241531|SUPERIORITY||P Value|0.36||||0.36|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Emotional functioning in patients with ICI secondary resistance||||0.36
91673920|NCT02654587|183241531|SUPERIORITY||P Value|0.24||||0.24|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Cognitive functioning in patients with ICI secondary resistance||||0.24
91673921|NCT02654587|183241531|SUPERIORITY|QLQ-C30 Social functioning|P Value|0.11||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
91673922|NCT02654587|183241532|SUPERIORITY||P Value|0.06||||0.06|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Fatigue in ICI secondary resistance||||0.06
91673923|NCT02654587|183241532|SUPERIORITY||P Value|0.0003||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Constipation in ICI secondary resistance||||0.0003
91673924|NCT02654587|183241532|SUPERIORITY||P Value|0.8||||0.8|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Dyspnea in ICI secondary resistance||||0.80
91673925|NCT02654587|183241532|SUPERIORITY||P Value|0.21||||0.21|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Nausea and Vomiting in ICI secondary resistance||||0.21
91673926|NCT02654587|183241532|SUPERIORITY||P Value|0.45||||0.45|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Pain in ICI secondary resistance||||0.45
91673927|NCT02654587|183241532|SUPERIORITY||P Value|0.87||||0.87|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Insomnia in ICI secondary resistance||||0.87
91673928|NCT02654587|183241532|SUPERIORITY||P Value|0.59||||0.59|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Appetite loss in ICI secondary resistance||||0.59
91673929|NCT02654587|183241532|SUPERIORITY||P Value|0.88||||0.88|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Diarrhea in ICI secondary resistance||||0.88
91673930|NCT02654587|183241532|SUPERIORITY||P Value|0.37||||0.37|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Financial difficulties in ICI secondary resistance||||0.37
91673931|NCT02654587|183241533|SUPERIORITY||P Value|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Alopecia in ICI secondary resistance||||<0.0001
91673932|NCT02654587|183241533|SUPERIORITY||P Value|0.03||||0.03|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Peripheral neuropathy in ICI secondary resistance||||0.03
91673933|NCT02654587|183241533|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Sore mouth in ICI secondary resistance||||0.01
91673934|NCT02654587|183241533|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Dysphagia in ICI secondary resistance||||0.01
91673935|NCT02654587|183241533|SUPERIORITY||P Value|0.35||||0.35|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in arm and shoulder||||0.35
91673936|NCT02654587|183241533|SUPERIORITY||P Value|0.43||||0.43|TWO_SIDED||||||Mantel Haenszel|||QLQ-LC13 Pain in chest in ICI secondary resistance||||0.43
91673937|NCT02654587|183241533|SUPERIORITY||P Value|0.78||||0.78|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in other parts||||0.78
91673938|NCT02654587|183241533|SUPERIORITY||P Value|0.23||||0.23|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Hemoptysis in ICI secondary resistance||||0.23
91673939|NCT02654587|183241533|SUPERIORITY||P Value|0.54||||0.54|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Coughing in ICI secondary resistance||||0.54
91485712|NCT00785928|182844663|SUPERIORITY_OR_OTHER|||||||0.633||95.0||||Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.633
91673940|NCT02654587|183241534|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.43|2.75|||Mantel Haenszel|||DCR at 6 months in patients with ICI secondary resistance||2.75|0.43|0.87
91673941|NCT02654587|183241534|SUPERIORITY||Odds Ratio (OR)|0.73||||0.37|TWO_SIDED|95.0|0.36|1.46|||Mantel Haenszel|||DCR at 6 months in ITT patients with ICI resistance (primary and secondary)||1.46|0.36|0.37
91673942|NCT02654587|183241535|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.29|TWO_SIDED|95.0|0.82|2.0|||t-test, 2 sided|||Median PFS in patients with ICI secondary resistance||2.0|0.82|0.29
91673943|NCT02654587|183241535|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.05|TWO_SIDED|95.0|1.18|2.28|||t-test, 2 sided|||Median PFS in ITT patients with ICI resistance (primary and secondary)||2.28|1.18|<0.05
91673944|NCT02654587|183241536|SUPERIORITY|ORR in ICI secondary resistance|Odds Ratio (OR)|0.33||||0.07|TWO_SIDED|95.0|0.1|1.11|||Mantel Haenszel|||||1.11|0.10|0.07
91673945|NCT02654587|183241536|SUPERIORITY|ORR in ITT population with ICI resistance (primary and secondary)|Odds Ratio (OR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.59|||Mantel Haenszel|||||0.59|0.08|0.002
91673946|NCT02654587|183241537|SUPERIORITY|Duration of response at 6 months in ICI secondary resistance|Hazard Ratio (HR)|1.14||||0.88|TWO_SIDED|95.0|0.25|5.3|||Regression, Cox|||||5.30|0.25|0.88
91673947|NCT02654587|183241537|SUPERIORITY|Duration of Response at 6 months in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.41||||0.57|TWO_SIDED|95.0|0.43|4.6|||Regression, Cox|||||4.60|0.43|0.57
91673948|NCT02654587|183241538|SUPERIORITY|Time to next lung cancer therapy in ICI secondary resistance|Hazard Ratio (HR)|1.85||||0.04|TWO_SIDED|95.0|1.03|3.31|||Regression, Cox|||||3.31|1.03|0.04
91673949|NCT02654587|183241538|SUPERIORITY|Time to next lung cancer therapy in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|1.07|2.36|||Regression, Cox|||||2.36|1.07|0.02
91673950|NCT02654587|183241539|SUPERIORITY||Hazard Ratio (HR)|1.36|||<|0.05|TWO_SIDED|95.0|1.0|1.86|||t-test, 2 sided|||||1.86|1.00|<0.05
91673951|NCT00904748|183241546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|98.68|||||TWO_SIDED|90.0|92.03|105.82|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.82|92.03|
91673952|NCT00904748|183241546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.23|||||TWO_SIDED|90.0|90.67|104.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.26|90.67|
91673953|NCT00904748|183241547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|80.83|||||TWO_SIDED|90.0|72.38|90.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||90.26|72.38|
91673954|NCT00904748|183241547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|78.76|||||TWO_SIDED|90.0|70.53|87.96|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||87.96|70.53|
91673955|NCT00904748|183241548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|99.12|||||TWO_SIDED|90.0|92.76|105.93|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.93|92.76|
91673956|NCT00904748|183241548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.84|||||TWO_SIDED|90.0|91.56|104.56|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.56|91.56|
91673957|NCT00904748|183241549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|90.0|-0.14|0.5|||ANOVA|||Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||0.50|-0.14|
91673958|NCT00904748|183241549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|90.0|-0.27|0.28|||ANOVA|||Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||0.28|-0.27|
91716646|NCT00526474|183325139|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.009|TWO_SIDED|95.0|0.85|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.85|0.009
91527859|NCT06173570|182930694|SUPERIORITY||Mean Difference (Net)|-44.21|||<|0.001|TWO_SIDED|95.0|-52.47|-35.94|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-35.94|-52.47|<0.001
91640783|NCT03480243|183173278|OTHER||Cmax Estimate Ratio|1.9|||||TWO_SIDED|90.0|1.59|2.27|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.27|1.59|
91640784|NCT03480243|183173278|OTHER||Cmax Estimate Ratio|1.81|||||TWO_SIDED|90.0|1.51|2.16|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.16|1.51|
91640785|NCT03480243|183173279|OTHER||AUC Estimate Ratio|1.8|||||TWO_SIDED|90.0|1.5|2.17|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.17|1.50|
91640786|NCT03480243|183173279|OTHER||AUC Estimate Ratio|1.64|||||TWO_SIDED|90.0|1.36|1.97|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||1.97|1.36|
91673959|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a responder rate (π) of 63% in the reference group, a clinically relevant delta (Δ) of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.0986|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.0986
91673960|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.5682|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.5682
91673961|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.8543|TWO_SIDED|5.0|-0.363|0.0284||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.8543
91673962|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.9167|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.9167
91673963|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.6052|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.6052
91673964|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.5369|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.5369
91640787|NCT03480243|183173280|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.77|2.55|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.55|1.77|
91640788|NCT03480243|183173280|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.78|2.56|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.56|1.78|
91640789|NCT03480243|183173281|OTHER||AUCtau Estimate Ratio|2.48|||||TWO_SIDED|90.0|2.02|3.03|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||3.03|2.02|
91640790|NCT03480243|183173281|OTHER||AUCtau Estimate Ratio|2.23|||||TWO_SIDED|90.0|1.82|2.73|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.73|1.82|
91640791|NCT04365387|183173306|OTHER||Cochran-Mantel-Haenszel|2.1|||||TWO_SIDED|90.0|-10.3|14.5|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using Cochran-Mantel-Haenszel (CMH).|||14.5|-10.3|
91640792|NCT04365387|183173307|OTHER||Cochran-Mantel-Haenszel|-4.6|||||TWO_SIDED|90.0|-14.9|5.7|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.7|-14.9|
91640793|NCT04365387|183173309|OTHER||Cochran-Mantel-Haenszel|1.4|||||TWO_SIDED|90.0|-3.2|5.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.9|-3.2|
91640794|NCT04365387|183173310|OTHER||Cochran-Mantel-Haenszel|13.3|||||TWO_SIDED|90.0|0.1|26.4|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH for non-Imputed values|||26.4|0.1|
91640795|NCT04365387|183173311|OTHER||Cochran-Mantel-Haenszel|1.3|||||TWO_SIDED|90.0|-9.3|11.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||11.9|-9.3|
91640796|NCT05770401|183173312|SUPERIORITY||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|1.227||0.014|TWO_SIDED|95.0|0.72|5.76|||ANCOVA|||The null hypothesis was there would be no significant difference in LCQ total score change from baseline to one-week post-treatment between groups.||5.76|.72|.014
91640797|NCT05770401|183173313|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|8.804||0.056|TWO_SIDED|95.0|-32.7|0.46|||ANCOVA|||The null hypothesis was there would be no significant difference in Cough Severity VAS Scores from baseline to one-week post-treatment between groups.||0.46|-32.7|.056
91640798|NCT01683565|183173319|OTHER|Analyses compared the change in Pervasive Developmental Disorders Screening Test-II scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.67||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The sample size was determined based on the goal of confirming trial feasibility and estimating effect sizes for a full-scale trial, not for a definitive test of efficacy. The enrollment goal was 40, which would have provided an indication of an expected effect size for a larger full-scale trial (e.g., 53% power to detect a 2-point decrease (approximately 0.7-SD based on a prior study) in Pervasive Developmental Disorders Screening Test-II score). Funding limitations capped enrollment at 31.||||0.67
91640799|NCT01683565|183173320|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Competence scores between groups (LCPUFA vs. Placebo).||||0.22
91640800|NCT01683565|183173320|OTHER|Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes||||||0.92||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo).||||0.92
91640801|NCT01683565|183173320|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.88|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo).||||0.88
91640802|NCT01683565|183173320|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.23|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo).||||0.23
91640803|NCT01683565|183173320|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.91|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo).||||0.91
91640804|NCT01683565|183173320|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.03|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo).||||0.03
91716647|NCT00526474|183325140|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.002|TWO_SIDED|95.0|0.78|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.78|0.002
91673965|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.7732|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.7732
91673966|NCT01682148|183241552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.1758|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.1758
91673967|NCT01682148|183241554|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.1324||||0.24|TWO_SIDED|95.0|-0.3531|0.0884||Based on a generalised linear model including factors for treatment, spasticity pattern, country and MAS baseline score.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0884|-0.3531|0.2400
91673968|NCT01682148|183241555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9448|TWO_SIDED|95.0|||||ANOVA|Analysis of variance (ANOVA) included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 4.||||0.9448
91673969|NCT01682148|183241555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5458|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 12.||||0.5458
91673970|NCT01682148|183241556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4006|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country.||||||0.4006
91673971|NCT01682148|183241557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|||||||Mann-Whitney U-test|||||||0.5747
91673972|NCT01682148|183241558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1802|||||||Mann-Whitney U-test|||||||0.1802
91673973|NCT04844021|183241581|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.22|||||TWO_SIDED|95.0|0.13|0.31||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.31|0.13|
91673974|NCT04844021|183241581|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.49|||||TWO_SIDED|95.0|0.37|0.61||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.61|0.37|
91673975|NCT01103479|183241590|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65||||0.32|TWO_SIDED|95.0|0.62|4.38||Random effects model adjusting for clustering by clinic|Mixed Models Analysis|||||4.38|0.62|0.32
91673976|NCT01103479|183241591|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.28|TWO_SIDED|95.0|0.53|1.2||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.20|0.53|0.28
91673977|NCT01103479|183241592|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.42|TWO_SIDED|95.0|0.6|3.43||Random effects model adjusted for clustering by clinic|Mixed Models Analysis|||||3.43|0.60|0.42
91673978|NCT01103479|183241593|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05||||0.38|TWO_SIDED|95.0|0.94|1.18||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.18|0.94|0.38
91673979|NCT01298778|183241594|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||acute pain scores with movement at 24 hours||||0.05
91673980|NCT02377921|183241602|SUPERIORITY||Least Squares (LS) Mean Difference|0.74||||0.5387|TWO_SIDED|95.0|-1.61|3.09||Generalized estimating equation (GEE) model includes change from Baseline (BL) as dependent variable, visit, treatment and visit by treatment as fixed factors, and BL values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||3.09|-1.61|0.5387
91673981|NCT02377921|183241603|SUPERIORITY||LS Mean Difference|-0.4||||0.6938|TWO_SIDED|95.0|-2.38|1.58||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||1.58|-2.38|0.6938
91673982|NCT02377921|183241604|SUPERIORITY||LS Mean Difference|-1.49||||0.5023|TWO_SIDED|95.0|-5.83|2.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||2.86|-5.83|0.5023
91673983|NCT02377921|183241605|SUPERIORITY||LS Mean Difference|-0.72||||0.2739|TWO_SIDED|95.0|-2.01|0.57||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||0.57|-2.01|0.2739
91716648|NCT00526474|183325141|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.81|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.81|<0.001
91716649|NCT00526474|183325142|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.86|0.001
91716650|NCT00526474|183325143|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9|||<|0.001|TWO_SIDED|95.0|0.85|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.85|<0.001
91716651|NCT00526474|183325144|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.151|TWO_SIDED|95.0|0.76|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.76|0.151
91716652|NCT00526474|183325145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
91716653|NCT00526474|183325146|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.108|TWO_SIDED|95.0|0.75|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.75|0.108
91716654|NCT00526474|183325147|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.733|TWO_SIDED|95.0|0.83|1.14|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.14|0.83|0.733
91716655|NCT00526474|183325148|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.411|TWO_SIDED|95.0|0.85|1.07|||Cox Proportional Hazards Regression||Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.07|0.85|0.411
91716656|NCT00526474|183325149|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
91716657|NCT00526474|183325150|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
91716658|NCT00526474|183325151|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.76|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.76|<0.001
91716659|NCT00526474|183325152|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.89|0.73|<0.001
91716660|NCT00526474|183325153|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.45|||<|0.001|TWO_SIDED|95.0|1.23|1.71|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.71|1.23|<0.001
91485713|NCT00785928|182844663|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.754
91485714|NCT00785928|182844663|SUPERIORITY_OR_OTHER|||||||0.289||95.0||||Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.289
91485715|NCT00785928|182844664|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.671
91673984|NCT02377921|183241606|SUPERIORITY||LS Mean Difference|-2.76||||0.1235|TWO_SIDED|95.0|-6.27|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-6.27|0.1235
91673985|NCT02377921|183241607|SUPERIORITY||LS Mean Difference|-0.43||||0.3907|TWO_SIDED|95.0|-1.4|0.55||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.55|-1.40|0.3907
91640805|NCT01683565|183173320|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.07|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo).||||0.07
91640806|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.31||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (10:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.31
91640807|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.47||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.47
91640808|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.38||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.38
91640809|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
91640810|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.16||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.16
91640811|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
91640812|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
91640813|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.21||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.21
91673986|NCT02377921|183241608|OTHER||LS Mean Difference|-10.98||||0.1964|TWO_SIDED|95.0|-27.64|5.68||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||5.68|-27.64|0.1964
91673987|NCT02377921|183241609|SUPERIORITY||LS Mean Difference|-1.4||||0.2241|TWO_SIDED|95.0|-3.66|0.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER - placebo|||0.86|-3.66|0.2241
91673988|NCT02377921|183241610|OTHER||LS Mean Difference|-0.32||||0.5608|TWO_SIDED|95.0|-1.39|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-1.39|0.5608
91640814|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.34||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.34
91640815|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.24||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.24
91640816|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.5||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo).||||0.50
91640817|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.07||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.07
91673989|NCT02443545|183241612|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.0000
91673990|NCT02443545|183241612|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0000
91673991|NCT02443545|183241612|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0000
91673992|NCT02443545|183241613|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.3146|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.3146
91673993|NCT02443545|183241613|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.9454|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.9454
91673994|NCT02443545|183241613|OTHER|One-sample t-test, to determine whether the change from baseline in MRI 2\* was significantly different from 0.||||||0.4336|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.4336
91673995|NCT02443545|183241614|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.9952|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.9952
91485716|NCT00785928|182844664|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.696
91673996|NCT02443545|183241614|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.0008|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0008
91673997|NCT02443545|183241614|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.042|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0420
91673998|NCT02139124|183241620|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.675|TWO_SIDED|95.0|-6.6|2.6||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo."||2.6|-6.6|0.6750
91673999|NCT02139124|183241620|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0013|TWO_SIDED|95.0|-11.5|-2.2||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo||-2.2|-11.5|0.0013
91674000|NCT02139124|183241620|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.672|TWO_SIDED|95.0|-6.8|2.7||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||2.7|-6.8|0.6720
91674001|NCT02139124|183241620|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0002|TWO_SIDED|95.0|-12.9|-3.2||The model include terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||-3.2|-12.9|0.0002
91674002|NCT03821272|183241634|SUPERIORITY||non-recurrence rate|0.45||||0.31|TWO_SIDED|95.0|0.17|0.77|||Fisher Exact|||||0.77|0.17|0.31
91674003|NCT03821272|183241635|SUPERIORITY||non-recurrence rate|0.8||||0.31|TWO_SIDED|95.0|0.28|0.99|||Fisher Exact|||||0.99|0.28|0.31
91674004|NCT03821272|183241636|SUPERIORITY||non-recurrence rate|0.56||||0.58|TWO_SIDED|95.0|0.21|0.86|||Fisher Exact|||||0.86|0.21|0.58
91674005|NCT03821272|183241637|SUPERIORITY||non-recurrence rate|0.8||||0.58|TWO_SIDED|95.0|0.28|0.99|||Fisher Exact|||||0.99|0.28|0.58
91674006|NCT05626803|183241650|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674007|NCT05626803|183241650|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674008|NCT05626803|183241650|SUPERIORITY|||||||0.0003|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0003
91674009|NCT05626803|183241652|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674010|NCT05626803|183241652|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674011|NCT05626803|183241652|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674012|NCT05626803|183241654|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674013|NCT05626803|183241654|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674014|NCT05626803|183241654|SUPERIORITY|||||||0.0017|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0017
91674015|NCT05626803|183241656|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91485717|NCT00785928|182844664|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.367
91674016|NCT05626803|183241656|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674017|NCT05626803|183241656|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674018|NCT05626803|183241658|SUPERIORITY|||||||0.0059|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0059
91674019|NCT05626803|183241658|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
91674020|NCT05626803|183241658|SUPERIORITY|||||||0.1899|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.1899
91674021|NCT05626803|183241660|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674022|NCT05626803|183241660|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
91674023|NCT05626803|183241660|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
91674024|NCT02516410|183241702|SUPERIORITY||Least squares (LS) mean difference|1.2|||=|0.1176|TWO_SIDED|95.0|-0.3|2.6|||Mixed-effect repeated measure (MMRM)|||||2.6|-0.3|= 0.1176
91674025|NCT04146363|183241718|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.6|37.8|||Cochran-Mantel-Haenszel|||||37.8|21.6|<0.000001
91674026|NCT04146363|183241719|SUPERIORITY||Risk Difference (RD)|42.0|||<|1e-06|TWO_SIDED|95.0|33.3|50.6|||Cochran-Mantel-Haenszel|||||50.6|33.3|<0.000001
91674027|NCT04146363|183241720|SUPERIORITY||Risk Difference (RD)|1.7||||0.218644|TWO_SIDED|95.0|-0.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|-0.6|0.218644
91674028|NCT04146363|183241721|SUPERIORITY||Risk Difference (RD)|9.6||||0.000498|TWO_SIDED|95.0|5.7|13.6|||Cochran-Mantel-Haenszel|||||13.6|5.7|0.000498
91674029|NCT04146363|183241722|SUPERIORITY||Risk Difference (RD)|30.8|||<|1e-06|TWO_SIDED|95.0|22.1|39.4|||Cochran-Mantel-Haenszel|||||39.4|22.1|<0.000001
91674030|NCT04146363|183241723|SUPERIORITY||Risk Difference (RD)|28.8|||<|1e-06|TWO_SIDED|95.0|21.3|36.3|||Cochran-Mantel-Haenszel|||||36.3|21.3|<0.000001
91674031|NCT04146363|183241724|SUPERIORITY||LS Mean Difference (Final Values)|-30.42|STANDARD_ERROR_OF_MEAN|3.915|<|1e-06|TWO_SIDED|95.0|-38.1|-22.7|||ANCOVA|||||-22.7|-38.1|<0.000001
91674032|NCT04146363|183241725|SUPERIORITY||Risk Difference (RD)|32.9|||<|1e-06|TWO_SIDED|95.0|24.6|41.3|||Cochran-Mantel-Haenszel|||||41.3|24.6|<0.000001
91674033|NCT04146363|183241726|SUPERIORITY||Risk Difference (RD)|35.1|||<|1e-06|TWO_SIDED|95.0|26.3|43.9|||Cochran-Mantel-Haenszel|||||43.9|26.3|<0.000001
91674034|NCT04146363|183241727|SUPERIORITY||LS Mean Difference (Final Values)|-38.31|STANDARD_ERROR_OF_MEAN|4.151|<|1e-06|TWO_SIDED|95.0|-46.4|-30.2|||ANCOVA|||||-30.2|-46.4|<0.000001
91674035|NCT04146363|183241728|SUPERIORITY||LS Mean Difference (Final Values)|-18.5|STANDARD_ERROR_OF_MEAN|2.0|<|1e-06|TWO_SIDED|95.0|-22.4|-14.5|||Mixed Models Analysis|||||-14.5|-22.4|<0.000001
91674036|NCT04146363|183241729|SUPERIORITY||Risk Difference (RD)|10.7||||0.000412|TWO_SIDED|95.0|6.2|15.2|||Cochran-Mantel-Haenszel|||||15.2|6.2|0.000412
91674037|NCT04146363|183241730|SUPERIORITY||LS Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.68|<|1e-06|TWO_SIDED|95.0|-7.1|-4.5|||ANCOVA|||||-4.5|-7.1|<0.000001
91674038|NCT04146363|183241731|SUPERIORITY||Risk Difference (RD)|38.8|||<|1e-06|TWO_SIDED|95.0|28.3|49.3|||Cochran-Mantel-Haenszel|||||49.3|28.3|<0.000001
91674039|NCT04146363|183241732|SUPERIORITY||Risk Difference (RD)|41.8|||<|1e-06|TWO_SIDED|95.0|31.2|52.3|||Cochran-Mantel-Haenszel|||||52.3|31.2|<0.000001
91674040|NCT04146363|183241733|SUPERIORITY||LS Mean Difference (Final Values)|-32.35|STANDARD_ERROR_OF_MEAN|5.23|<|1e-06|TWO_SIDED|95.0|-42.6|-22.1|||ANCOVA|||||-22.1|-42.6|<0.000001
91674041|NCT04146363|183241734|SUPERIORITY||LS Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.098|<|1e-06|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA|||||-0.6|-0.9|<0.000001
91674042|NCT04146363|183241735|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|26.2|43.0|||Cochran-Mantel-Haenszel|||||43.0|26.2|<0.000001
91674043|NCT04146363|183241736|SUPERIORITY||Risk Difference (RD)|1.5||||0.275529|TWO_SIDED|95.0|-0.8|3.9|||Cochran-Mantel-Haenszel|||||3.9|-0.8|0.275529
91674044|NCT04146363|183241737|SUPERIORITY||Risk Difference (RD)|5.3||||0.016656|TWO_SIDED|95.0|1.9|8.6|||Cochran-Mantel-Haenszel|||||8.6|1.9|0.016656
91674045|NCT04146363|183241738|SUPERIORITY||Risk Difference (RD)|19.3||||3e-06|TWO_SIDED|95.0|13.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|13.7|0.000003
91674046|NCT04146363|183241739|SUPERIORITY||Risk Difference (RD)|1.8||||0.244105|TWO_SIDED|95.0|-0.8|4.3|||Cochran-Mantel-Haenszel|||||4.3|-0.8|0.244105
91674047|NCT04146363|183241740|SUPERIORITY||Risk Difference (RD)|5.8||||0.01445|TWO_SIDED|95.0|2.2|9.4|||Cochran-Mantel-Haenszel|||||9.4|2.2|0.014450
91674048|NCT04146363|183241741|SUPERIORITY||Risk Difference (RD)|20.9||||2e-06|TWO_SIDED|95.0|14.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|14.9|0.000002
91674049|NCT04146363|183241742|SUPERIORITY||LS Mean Difference (Final Values)|-30.29|STANDARD_ERROR_OF_MEAN|3.203|<|1e-06|TWO_SIDED|95.0|-36.59|-24.0|||ANCOVA|||||-24.00|-36.59|<0.000001
91674050|NCT04146363|183241744|SUPERIORITY||Risk Difference (RD)|17.9||||0.072375|TWO_SIDED|95.0|-2.3|38.1|||Cochran-Mantel-Haenszel|||||38.1|-2.3|0.072375
91674051|NCT04146363|183241744|SUPERIORITY||Risk Difference (RD)|17.5||||0.106653|TWO_SIDED|95.0|-4.5|39.5|||Cochran-Mantel-Haenszel|||||39.5|-4.5|0.106653
91674052|NCT04146363|183241745|SUPERIORITY||Risk Difference (RD)|28.0||||0.029857|TWO_SIDED|95.0|2.8|53.2|||Cochran-Mantel-Haenszel|||||53.2|2.8|0.029857
91674053|NCT04146363|183241745|SUPERIORITY||Risk Difference (RD)|29.0||||0.019744|TWO_SIDED|95.0|4.6|53.3|||Cochran-Mantel-Haenszel|||||53.3|4.6|0.019744
91674054|NCT04146363|183241746|SUPERIORITY||Risk Difference (RD)|15.8||||0.268265|TWO_SIDED|95.0|-12.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|-12.2|0.268265
91674055|NCT04146363|183241746|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
91674056|NCT04146363|183241747|SUPERIORITY||Risk Difference (RD)|18.6||||0.185361|TWO_SIDED|95.0|-9.3|46.6|||Cochran-Mantel-Haenszel|||||46.6|-9.3|0.185361
91674057|NCT04146363|183241747|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
91674058|NCT04146363|183241748|SUPERIORITY||LS Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|4.756||0.714208|TWO_SIDED|95.0|-11.15|7.66|||ANCOVA|||||7.66|-11.15|0.714208
91674059|NCT04146363|183241748|SUPERIORITY||LS Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|4.4748||0.237855|TWO_SIDED|95.0|-15.01|3.76|||ANCOVA|||||3.76|-15.01|0.237855
91674060|NCT04146363|183241749|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|1e-06|TWO_SIDED|95.0|0.1|0.2|||ANCOVA|||UK||0.2|0.1|<0.000001
91674061|NCT04146363|183241749|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.01|<|1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||US||0.1|0.1|<0.000001
91674062|NCT04146363|183241750|SUPERIORITY||LS Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|1.66|<|1e-06|TWO_SIDED|95.0|5.0|11.5|||ANCOVA|||||11.5|5.0|<0.000001
91674063|NCT04146363|183241751|SUPERIORITY||LS Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|0.8|<|1e-06|TWO_SIDED|95.0|-8.9|-5.7|||Mixed Models Analysis|||||-5.7|-8.9|<0.000001
91674064|NCT04146363|183241752|SUPERIORITY||LS Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.917||0.716224|TWO_SIDED|95.0|-6.93|4.8|||ANCOVA|||||4.80|-6.93|0.716224
91674065|NCT04146363|183241753|SUPERIORITY||LS Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|2.599||0.089275|TWO_SIDED|95.0|-9.73|0.72|||ANCOVA|||||0.72|-9.73|0.089275
91674066|NCT04146363|183241754|SUPERIORITY||LS Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.796||4e-05|TWO_SIDED|95.0|-4.88|-1.75|||ANCOVA|||||-1.75|-4.88|0.000040
91674067|NCT04146363|183241755|SUPERIORITY||LS Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.697||0.000127|TWO_SIDED|95.0|-4.07|-1.33|||ANCOVA|||||-1.33|-4.07|0.000127
91674068|NCT04146363|183241756|SUPERIORITY||LS Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.121||0.455291|TWO_SIDED|95.0|-0.33|0.15|||ANCOVA|||||0.15|-0.33|0.455291
91674069|NCT04146363|183241757|SUPERIORITY||LS Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.52||6.9e-05|TWO_SIDED|95.0|-10.1|-3.9|||Mixed Models Analysis|||||-3.9|-10.1|0.000069
91674070|NCT00107042|183241760|SUPERIORITY_OR_OTHER|||||||0.2954|||||||Fisher Exact|||The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.||||0.2954
91674071|NCT00107042|183241760|SUPERIORITY_OR_OTHER||Response Rate|87.23|||||TWO_SIDED|95.0|74.26|95.17|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||95.17|74.26|
91674072|NCT00107042|183241760|SUPERIORITY_OR_OTHER||Response Rate|94.55|||||TWO_SIDED|95.0|84.88|98.86|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here."||98.86|84.88|
91674073|NCT00107042|183241761|SUPERIORITY_OR_OTHER|||||||0.0608|||||||Wilcoxon (Mann-Whitney)|||Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.||||0.0608
91674074|NCT00107042|183241761|SUPERIORITY_OR_OTHER||Mean response|2.29|||||TWO_SIDED|95.0|2.05|2.53|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||2.53|2.05|
91674075|NCT00107042|183241761|SUPERIORITY_OR_OTHER||Response rate|2.58|||||TWO_SIDED|95.0|2.4|2.76|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here."||2.76|2.40|
91674076|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.2455|STANDARD_ERROR_OF_MEAN|0.1757||0.1667|||||||Regression, Linear|||This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.1667
91674077|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficent|-0.0025|STANDARD_ERROR_OF_MEAN|0.1792||0.989||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.9890
91674078|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coeffcient|0.2053|STANDARD_ERROR_OF_MEAN|0.1885||0.2796||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2796
91674079|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regresssion coeffcient|-0.4726|STANDARD_ERROR_OF_MEAN|0.1734||0.008||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0080
91674080|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.2189|STANDARD_ERROR_OF_MEAN|0.1905||0.2543||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2543
91674081|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.2994|STANDARD_ERROR_OF_MEAN|0.3292||0.3661||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.||||0.3661
91674082|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.0083|STANDARD_ERROR_OF_MEAN|0.3497||0.9812||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.||||0.9812
91674083|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0663|STANDARD_ERROR_OF_MEAN|0.2314||0.7766||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7766
91674084|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.2929|STANDARD_ERROR_OF_MEAN|0.2508||0.2492||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2492
91674085|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coeffcient|-0.316|STANDARD_ERROR_OF_MEAN|0.1826||0.0877||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (\<25.0) vs. Overweight and Obsese (\>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0877
91674086|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0292|STANDARD_ERROR_OF_MEAN|0.0113||0.0117||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.||||0.0117
91674087|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0578|STANDARD_ERROR_OF_MEAN|0.2163||0.7899||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7899
91674088|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.5339|STANDARD_ERROR_OF_MEAN|0.2803||0.0607||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0607
91674089|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3883|STANDARD_ERROR_OF_MEAN|0.2779||0.167||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. \<= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. \<= 14 year olds is presented."||||0.1670
91674090|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.0344|STANDARD_ERROR_OF_MEAN|0.2065||0.8682||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. \<= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented."||||0.8682
91674091|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.1532|STANDARD_ERROR_OF_MEAN|0.1896||0.4219||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4219
91674092|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.7752|STANDARD_ERROR_OF_MEAN|0.242||0.002||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0020
91674093|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.2921|STANDARD_ERROR_OF_MEAN|0.2086||0.1659||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.1659
91674094|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-1.6163|STANDARD_ERROR_OF_MEAN|0.2839||0||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0000
91674095|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1788|STANDARD_ERROR_OF_MEAN|0.2463||0.4701||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4701
91674096|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|0.1083|STANDARD_ERROR_OF_MEAN|0.3488||0.7572||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.7572
91674097|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0307|STANDARD_ERROR_OF_MEAN|0.1809||0.8657||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.8657
91674098|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3548|STANDARD_ERROR_OF_MEAN|0.2076||0.0917||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0917
91674099|NCT00107042|183241764|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3474|STANDARD_ERROR_OF_MEAN|0.3924||0.3788||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.3788
91674100|NCT00107042|183241765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.2068|TWO_SIDED|95.0|0.6|10.76|||Univariate regression, logistic||The reference group is the 'Recombivax' group.|||10.76|0.60|0.2068
91674101|NCT00107042|183241766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.5524|TWO_SIDED|95.0|0.38|6.01|||Univariate regression, logistic||The reference group is the 'Other Sites' group.|||6.01|0.38|0.5524
91674102|NCT00107042|183241767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4646|TWO_SIDED|95.0|0.36|9.36|||Univariate regression, logistic||The reference group is the '15-17 year' age group|||9.36|0.36|0.4646
91674103|NCT00107042|183241768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.339|TWO_SIDED|95.0|0.09|2.3|||Univariate regression, logistic||The reference group is the 'Female' group.|||2.30|0.09|0.3390
91674104|NCT00107042|183241769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86||||0.0102|TWO_SIDED|95.0|1.58|29.78|||Univariate regression, logistic||The reference group is the 'Hispanic: NO' group.|||29.78|1.58|0.0102
91674105|NCT00107042|183241769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.38||||0.0118|TWO_SIDED|95.0|1.56|34.95||Since Hispanic (no, yes) was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Hispanic: NO group."|||34.95|1.56|0.0118
91674106|NCT00107042|183241770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.4241|TWO_SIDED|95.0|0.04|3.84|||Univariate regression, logistic||The reference group is the 'White' group.|||3.84|0.04|0.4241
91674107|NCT00107042|183241770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.2685|TWO_SIDED|95.0|0.34|50.76|||Univariate regression, logistic||The reference group is the 'White' group.|||50.76|0.34|0.2685
91674108|NCT00107042|183241771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.939|TWO_SIDED|95.0|0.05|15.44|||Univariate regression, logistic||The reference group is the 'Stage 5' group.|||15.44|0.05|0.9390
91674109|NCT00107042|183241772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6181|TWO_SIDED|95.0|0.3|7.39|||Univariate regression, logistic||"The reference group is the Stage 5 group."|||7.39|0.30|0.6181
91674110|NCT00107042|183241773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.1943|TWO_SIDED|95.0|0.1|1.6|||Univariate regression, logistic||"The reference group is the Normal and Underweight (\<25.0) group."|||1.60|0.10|0.1943
91674111|NCT00107042|183241774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.2542|TWO_SIDED|95.0|0.1|1.86|||Univariate regression, logistic||"The reference group is the Ever smoked cigarettes: NO group."|||1.86|0.10|0.2542
91674112|NCT00107042|183241775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.14||||0.0161|TWO_SIDED|95.0|0.03|0.69|||Univariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.69|0.03|0.0161
91674113|NCT00107042|183241775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.0222|TWO_SIDED|95.0|0.02|0.74||Since sexual identity was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.74|0.02|0.0222
91674114|NCT00107042|183241776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8945|TWO_SIDED|95.0|0.12|11.83|||Univariate regression, logistic||"The reference group is the Never (had sex)group."|||11.83|0.12|0.8945
91674115|NCT00107042|183241776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.019|TWO_SIDED|95.0|0.02|0.7|||Univariate regression, logistic||"The reference group is the Never (had sex) group."|||0.70|0.02|0.0190
91674116|NCT00107042|183241777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.0042|TWO_SIDED|95.0|0.01|0.48|||Univariate regression, logistic||"The reference group is the 0 partners group"|||0.48|0.01|0.0042
91674117|NCT00107042|183241777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.6893||95.0|||||Univariate regression, Logistic||"The reference group is the 0 partners group.~Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity"|||||0.6893
91674118|NCT00107042|183241778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.015||||0.0003|TWO_SIDED|95.0|0.0|0.19|||Univariate regression, logistic||"The reference group is hte 0 Partners group."|||0.19|0.00|0.0003
91674119|NCT00107042|183241778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||1|TWO_SIDED|95.0|0.0|10.01|||Univariate regression, Logistic||"The reference group is the 0 Partners group"|||10.01|0.00|1.0000
91674120|NCT00107042|183241779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.5503|TWO_SIDED|95.0|0.05|4.86|||Univariate regression, logistic||"The reference group is the 0 Partners group"|||4.86|0.05|0.5503
91674121|NCT00107042|183241779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8904|TWO_SIDED|95.0|0.13|10.46|||Univariate Regression, Logistic||"The reference group is the 0 Partners group."|||10.46|0.13|0.8904
91674122|NCT00107042|183241780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.301|TWO_SIDED|95.0|0.12|1.92|||Univariate regression, logistic||"The reference group is the Ever drank alcohol: NO group."|||1.92|0.12|0.3010
91674123|NCT00107042|183241781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.0501|TWO_SIDED|95.0|0.06|1.0|||Univariate regression, logistic||"The reference group is the Ever smoked marijuana: NO group."|||1.00|0.06|0.0501
91674124|NCT00107042|183241782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.3846|TWO_SIDED|95.0|0.04|3.61|||Univariate regression, logistic||"The reference group is the Ever used drugs not prescribed: NO group."|||3.61|0.04|0.3846
91674125|NCT00107042|183241783|SUPERIORITY_OR_OTHER|||||||0.3827||95.0|||||Fisher Exact|||||||0.3827
91674126|NCT00107042|183241783|SUPERIORITY_OR_OTHER||Responding Rate|81.08|||||TWO_SIDED|95.0|68.84|92.04|||||Response rate=Total number subjects responded/Total number subjects in arm|||92.04|68.84|
91674127|NCT00107042|183241783|SUPERIORITY_OR_OTHER||Responding Rate|88.0|||||TWO_SIDED|95.0|75.69|95.47|||||Response rate=Total number subjects responded/Total number subjects in arm|||95.47|75.69|
91674128|NCT00107042|183241784|SUPERIORITY_OR_OTHER||Responding rate|98.08|||||TWO_SIDED|95.0|89.74|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% CI|||||99.95|89.74|
91674129|NCT00107042|183241785|SUPERIORITY_OR_OTHER||Responding Rate|91.49||||||95.0|79.62|97.63||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95 % confidence interval|||||97.63|79.62|
91674130|NCT00107042|183241786|SUPERIORITY_OR_OTHER||Responding Rate %|98.11|||||TWO_SIDED|95.0|89.93|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% confidence interval||"For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered Positive. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is Negative."|||99.95|89.93|
91674131|NCT00107042|183241787|SUPERIORITY_OR_OTHER|||||||0.2938||95.0|||||Fisher Exact|||||||0.2938
91674132|NCT00107042|183241787|SUPERIORITY_OR_OTHER||Responding Rate %|85.37|||||TWO_SIDED|95.0|70.83|94.43|||95 % confidence interval|||||94.43|70.83|
91674133|NCT00107042|183241787|SUPERIORITY_OR_OTHER||Responding Rate %|93.62|||||TWO_SIDED|95.0|82.46|98.66|||95% confidence interval|||||98.66|82.46|
91674134|NCT01286558|183241813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||||95.0|-0.22|3.14|||ANCOVA|||||3.14|-0.22|
91674135|NCT01286558|183241814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||||95.0|-0.36|4.64|||ANCOVA|||||4.64|-0.36|
91674136|NCT01286558|183241815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||||95.0|-2.58|0.15|||ANCOVA|||||0.15|-2.58|
91674137|NCT01286558|183241816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||||95.0|-4.16|0.35|||ANCOVA|||||0.35|-4.16|
91674138|NCT01286558|183241817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||||95.0|-2.57|0.79|||ANCOVA|||||0.79|-2.57|
91674139|NCT01286558|183241818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-4.27|0.99|||ANCOVA|||||0.99|-4.27|
91674140|NCT01287039|183241837|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.501|||<|0.0001|TWO_SIDED|95.0|0.3726|0.6737||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6737|0.3726|<0.0001
91674141|NCT01287039|183241838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.0311|<|0.0001|TWO_SIDED|95.0|0.076|0.198|||Mixed Model Repeated Measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.198|0.076|<0.0001
91674142|NCT01287039|183241839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.0967||0.0143|TWO_SIDED|95.0|0.048|0.428|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.428|0.048|0.0143
91674143|NCT01287039|183241840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.0681||0.0001|TWO_SIDED|95.0|-0.399|-0.132|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||-0.132|-0.399|0.0001
91674144|NCT01287039|183241841|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.575|||<|0.0001|TWO_SIDED|95.0|0.44|0.75|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.750|0.440|<0.0001
91674145|NCT01287039|183241842|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.0125|<|0.0001|TWO_SIDED|95.0|0.034|0.083|||Mixed model repeated measures|||For each week, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.083|0.034|<0.0001
91674146|NCT01287039|183241843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.1632||0.0919|TWO_SIDED|95.0|-0.597|0.045|||Mixed model repeated measures|||Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, OCS use at enrollment as fixed factors, and covariate for baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.045|-0.597|0.0919
91674147|NCT01287039|183241844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.0244|<|0.0001|TWO_SIDED|95.0|-0.514|-0.418|||Mixed model repeated measures|||"Eosinophil Count Over 16 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.418|-0.514|<0.0001
91485718|NCT00785928|182844664|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.645
91485719|NCT00785928|182844664|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.944
91485720|NCT00785928|182844664|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.133
91674148|NCT01287039|183241844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.455|STANDARD_ERROR_OF_MEAN|0.0182|<|0.0001|TWO_SIDED|95.0|-0.491|-0.419|||Mixed model repeated measures|||"Eosinophil Count Over 52 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.419|-0.491|<0.0001
91674149|NCT01287039|183241846|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4499|||<|0.0001|TWO_SIDED|95.0|0.3255|0.622||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6220|0.3255|<0.0001
91674150|NCT01287039|183241846|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.6595||||0.2572|TWO_SIDED|95.0|0.321|1.355||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.3550|0.3210|0.2572
91485721|NCT00785928|182844665|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||Pairwise comparison (1-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.457
91485722|NCT00785928|182844665|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Pairwise comparison (1-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.874
91485723|NCT00785928|182844665|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Pairwise comparison (1-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.278
91485724|NCT00785928|182844665|SUPERIORITY_OR_OTHER|||||||0.357||95.0||||Pairwise comparison (1-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.357
91485725|NCT00785928|182844665|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||Pairwise comparison (1-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.271
91485726|NCT00785928|182844665|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Pairwise comparison (1-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.048
91485727|NCT00785928|182844666|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||This p-value is from 2-sided comparison of 1 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||0.875
91674151|NCT01117337|183241852|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
91674152|NCT01117337|183241853|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||||||0.56
91674153|NCT03575871|183241854|SUPERIORITY||Difference in Percentage|19.3||||0.0008|TWO_SIDED|95.0|9.6|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|9.6|0.0008
91674154|NCT03575871|183241854|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|18.6|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|18.6|<0.0001
91674155|NCT03575871|183241855|SUPERIORITY||Difference in Percentage|33.9|||<|0.0001|TWO_SIDED|95.0|23.3|44.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.4|23.3|<0.0001
91674156|NCT03575871|183241855|SUPERIORITY||Difference in Percentage|50.5|||<|0.0001|TWO_SIDED|95.0|40.0|60.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.9|40.0|<0.0001
91485728|NCT00785928|182844666|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 3 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
91674157|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|19.2||||0.0002|TWO_SIDED|95.0|11.0|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|11.0|0.0002
91674158|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|31.2|||<|0.0001|TWO_SIDED|95.0|22.3|40.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.2|22.3|<0.0001
91674159|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|27.5|||<|0.0001|TWO_SIDED|95.0|18.9|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|18.9|<0.0001
91674160|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|46.4|||<|0.0001|TWO_SIDED|95.0|37.2|55.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.7|37.2|<0.0001
91674161|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|27.4|||<|0.0001|TWO_SIDED|95.0|16.8|38.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.0|16.8|<0.0001
91674162|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|39.8|||<|0.0001|TWO_SIDED|95.0|28.9|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|28.9|<0.0001
91485729|NCT00785928|182844666|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 10 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
91674163|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|18.9|39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.6|18.9|<0.0001
91674164|NCT03575871|183241856|SUPERIORITY||Difference in Percentage|38.6|||<|0.0001|TWO_SIDED|95.0|28.1|49.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.1|28.1|<0.0001
91674165|NCT03575871|183241857|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
91674166|NCT03575871|183241857|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.6|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.6|-2.8|<0.0001
91674167|NCT03575871|183241859|SUPERIORITY||Difference in Percentage|8.8||||0.015|TWO_SIDED|95.0|2.8|14.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.9|2.8|0.0150
91674168|NCT03575871|183241859|SUPERIORITY||Difference in Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|15.0|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|15.0|<0.0001
91674169|NCT03575871|183241859|SUPERIORITY||Difference in Percentage|20.0||||0.0004|TWO_SIDED|95.0|10.9|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|10.9|0.0004
91674170|NCT03575871|183241859|SUPERIORITY||Difference in Percentage|44.3|||<|0.0001|TWO_SIDED|95.0|34.8|53.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.8|34.8|<0.0001
91674171|NCT03575871|183241859|SUPERIORITY||Difference in Percentage|30.4|||<|0.0001|TWO_SIDED|95.0|19.7|41.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||41.2|19.7|<0.0001
91674172|NCT03575871|183241859|SUPERIORITY||Difference in Percentage|47.4|||<|0.0001|TWO_SIDED|95.0|36.8|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|36.8|<0.0001
91640818|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.10
91716661|NCT00526474|183325154|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.42|||<|0.001|TWO_SIDED|95.0|1.31|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.31|<0.001
91485730|NCT00785928|182844666|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||This p-value is from a 2-sided comparison of 30 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.304
91485731|NCT00785928|182844666|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This p-value is from a 2-sided comparison of 60 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.489
91640819|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
91640820|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.71||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.71
91640821|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
91640822|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo).||||0.10
91640823|NCT01683565|183173321|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo).||||0.10
91640824|NCT01195662|183173328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.1485||0.0002|TWO_SIDED|95.0|-6.54|-2.02||Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure used.|Longitudinal repeated measures|Data from all weeks during the double-blind treatment period were included.||Longitudinal repeated measures analysis using 'direct likelihood', with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, as well as continuous fixed covariates of baseline SBP value and baseline SBP value-by-week interaction. Unstructured matrix for within-subject error variance-covariance used. 80% power to detect a difference of 4 mmHg in mean change from baseline, 75% power to meet both co-primary endpoints with overall Type I error.||-2.02|-6.54|0.0002
91640825|NCT01195662|183173329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.0773|<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Longitudinal repeated measures|Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure was used.||A longitudinal repeated measures analysis used, with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, continuous fixed covariates of baseline HbA1c value and baseline HbA1c value-by-week interaction. Only data up to Week 12 included. All data used in the model even if participants discontinued prior to Week 12. A heirarchical closed testing procedure (sequential) was used and testing performed since first primary endpoint was significant.||-0.46|-0.76|<0.0001
91640826|NCT01195662|183173330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.368||0.0012|TWO_SIDED|95.0|-7.14|-1.76||Endpoint tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate was used. By applying sequential testing procedure, the testing was performed since the prior endpoint was significant.||-1.76|-7.14|0.0012
91640827|NCT01195662|183173331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.69||0.1619|TWO_SIDED|95.0|-2.32|0.39||Endpoint tested following a sequential testing procedure at alpha=0.05.|Longitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline seated diastolic BP value and baseline seated diastolic BP value by week interaction.||0.39|-2.32|0.1619
91640828|NCT01195662|183173332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.8635|||TWO_SIDED|95.0|-3.68|-0.29|||ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate. A hierarchical closed testing procedure was implemented to control the family-wise type I error rate related to the co-primary and secondary endpoints at the 2-sided 0.05 level. Statistical testing of this endpoint was not performed since the prior secondary endpoint was not statistically significant.||-0.29|-3.68|
91640829|NCT01195662|183173333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|-0.57|-0.23|||lLongitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline serum uric acid value and baseline seated serum uric acid value by week interaction. By applying sequential testing procedure at alpha=0.05, no testing was performed since the prior secondary endpoint was not significant.||-0.23|-0.57|
91640830|NCT03039699|183173350|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91793120|NCT02032823|183463948|SUPERIORITY||Hazard Ratio (HR)|0.581||||7.3e-06|TWO_SIDED|99.5|0.409|0.816||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.816|0.409|0.0000073
91485732|NCT00785928|182844666|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||This p-value is from a 2-sided comparison of 120 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.091
91485733|NCT00785928|182844667|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.746
91485734|NCT00785928|182844667|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.393
91485735|NCT00785928|182844667|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.549
91485736|NCT00785928|182844667|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.619
91674173|NCT03575871|183241860|SUPERIORITY||Difference in Percentage|5.1||||0.0459|TWO_SIDED|95.0|0.2|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.2|0.0459
91674174|NCT03575871|183241860|SUPERIORITY||Difference in Percentage|14.2||||0.0005|TWO_SIDED|95.0|7.8|20.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.5|7.8|0.0005
91674175|NCT03575871|183241860|SUPERIORITY||Difference in Percentage|12.9||||0.0019|TWO_SIDED|95.0|6.3|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.3|0.0019
91640831|NCT03039699|183173351|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0675
91640832|NCT03039699|183173351|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0675
91640833|NCT03039699|183173351|SUPERIORITY|||||||0.5569||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.5569
91640834|NCT03039699|183173352|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0696
91640835|NCT03039699|183173352|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0696
91640836|NCT03039699|183173352|SUPERIORITY|||||||0.1998||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.1998
91640837|NCT03039699|183173353|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
91640838|NCT03039699|183173354|SUPERIORITY|||||||0.89||||||"The p-value associated with treatment\*visit interaction of total CDS score from 24 hours to 48 and 72 hours of treatment between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.89
91640839|NCT03039699|183173355|SUPERIORITY|||||||0.0044|||||||Wilcoxon (Mann-Whitney)|||||||0.0044
91640840|NCT03039699|183173356|SUPERIORITY|||||||0.5488||||||nonadjusted p-value|Fisher Exact|||Day 3 comparison||||0.5488
91640841|NCT03039699|183173356|SUPERIORITY|||||||0.814||||||nonadjusted p-value|Fisher Exact|||Day 4 comparison||||0.8140
91674176|NCT03575871|183241860|SUPERIORITY||Difference in Percentage|31.8|||<|0.0001|TWO_SIDED|95.0|23.6|39.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.9|23.6|<0.0001
91640842|NCT03039699|183173356|SUPERIORITY|||||||0.1248||||||nonadjusted p-value|Fisher Exact|||Day 6 comparison||||0.1248
91640843|NCT03039699|183173356|SUPERIORITY|||||||0.3889||||||nonadjusted p-value|Fisher Exact|||Day 10 comparison||||0.3889
91640844|NCT03039699|183173357|SUPERIORITY|||||||0.3593|||||||Fisher Exact|||||||0.3593
91640845|NCT02451137|183173392|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0308|TWO_SIDED|95.4|1.01|1.39||Threshold for significance at 0.046 level.|Regression, Logistic|||A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (\<8%,\<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).||1.39|1.01|0.0308
91640846|NCT01740297|183173428|SUPERIORITY||Odds Ratio (OR)|2.9||||0.002|TWO_SIDED|95.0|1.5|5.5|||Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.5|1.5|0.002
91640847|NCT01740297|183173431|OTHER||Odds Ratio (OR)|1.9||||0.033|TWO_SIDED|95.0|1.1|3.4||P-value is descriptive|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||3.4|1.1|0.033
91640848|NCT01740297|183173432|OTHER||Odds Ratio (OR)|2.8||||0.007|TWO_SIDED|95.0|1.4|5.8||P-value is descriptive.|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.8|1.4|0.007
91485737|NCT00785928|182844667|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.893
91485738|NCT00785928|182844667|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.066
91485739|NCT00785928|182844668|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.583
91527860|NCT06173570|182930695|SUPERIORITY||Mean Difference (Net)|-5.93||||0.275|TWO_SIDED|95.0|-16.57|4.71|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||4.71|-16.57|0.275
91640849|NCT01740297|183173433|OTHER||Hazard Ratio (HR)|1.41||||0.228|TWO_SIDED|95.0|0.8|2.49||P-value is descriptive|Log Rank||Obtained from unstratified Cox Proportional Hazard Model.|||2.49|0.80|0.228
91640850|NCT01740297|183173435|OTHER||Hazard Ratio (HR)|0.83||||0.348|TWO_SIDED|95.0|0.56|1.23|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.23|0.56|0.348
91674177|NCT03575871|183241860|SUPERIORITY||Difference in Percentage|11.9||||0.0246|TWO_SIDED|95.0|2.4|21.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.4|2.4|0.0246
91793121|NCT02032823|183463949|SUPERIORITY||Hazard Ratio (HR)|0.574||||2.57e-05|TWO_SIDED|99.5|0.392|0.831||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.831|0.392|0.0000257
91485740|NCT00785928|182844668|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.311
91485741|NCT00785928|182844668|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.752
91485742|NCT00785928|182844668|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.737
91640851|NCT01740297|183173436|OTHER|||||||0.696|||||||Chi-squared, Corrected|||||||0.696
91674178|NCT03575871|183241860|SUPERIORITY||Difference in Percentage|26.9|||<|0.0001|TWO_SIDED|95.0|17.0|36.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.9|17.0|<0.0001
91674179|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value was not estimable since there were no events.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
91485743|NCT00785928|182844668|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.522
91485744|NCT00785928|182844668|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.073
91485745|NCT00785928|182844669|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.969
91485746|NCT00785928|182844669|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.352
91485747|NCT00785928|182844669|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.406
91485748|NCT00785928|182844669|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.266
91485749|NCT00785928|182844669|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.708
91640852|NCT01740297|183173437|OTHER||Hazard Ratio (HR)|0.8||||0.474|TWO_SIDED|95.0|0.44|1.46|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.46|0.44|0.474
91640853|NCT01740297|183173439|OTHER||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.55|1.09|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.09|0.55|0.14
91640854|NCT01740297|183173440|OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.56|1.24|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.24|0.56|0.37
91640855|NCT02163759|183173465|SUPERIORITY||Difference in Remission Rates|12.3||||0.0173|TWO_SIDED|95.0|1.59|20.6||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||20.60|1.59|0.0173
91640856|NCT02163759|183173466|SUPERIORITY||Difference in Remission Rates|-3.1||||0.5055|TWO_SIDED|95.0|-12.61|6.37||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||6.37|-12.61|0.5055
91640857|NCT02163759|183173467|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
91640858|NCT02163759|183173468|SUPERIORITY||Difference in Response Rates|6.9||||0.4434|TWO_SIDED|95.0|-7.03|20.62||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||20.62|-7.03|0.4434
91640859|NCT02163759|183173468|SUPERIORITY||Difference in Response Rates|4.8||||0.4122|TWO_SIDED|95.0|-6.72|16.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.07|-6.72|0.4122
91640860|NCT02163759|183173469|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
91640861|NCT02163759|183173470|SUPERIORITY||Difference in Response Rates|17.9||||0.0173|TWO_SIDED|95.0|4.49|29.5||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||29.50|4.49|0.0173
91640862|NCT02163759|183173470|SUPERIORITY||Difference in Response Rates|7.4||||0.1886|TWO_SIDED|95.0|-3.77|18.32||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||18.32|-3.77|0.1886
91674180|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|1.9||||0.2262|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2262
91674181|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|1.9||||0.2223|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2223
91674182|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|4.5||||0.0597|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0597
91485750|NCT00785928|182844669|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.012
91485751|NCT00785928|182844670|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.880
91485752|NCT00785928|182844670|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.575
91640863|NCT02163759|183173471|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
91640864|NCT02163759|183173472|SUPERIORITY||Difference in Remission Rates|13.8||||0.1347|TWO_SIDED|95.0|2.97|22.15||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.15|2.97|0.1347
91640865|NCT02163759|183173472|SUPERIORITY||Difference in Remission Rates|0.5||||0.9138|TWO_SIDED|95.0|-8.95|9.92||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.92|-8.95|0.9138
91640866|NCT02163759|183173473|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
91640867|NCT02163759|183173474|SUPERIORITY||Difference in Remission Rates|26.3||||0.0173|TWO_SIDED|95.0|12.1|37.86||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||37.86|12.10|0.0173
91640868|NCT02163759|183173474|SUPERIORITY||Difference in Remission Rates|13.2||||0.0313|TWO_SIDED|95.0|0.93|24.94||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||24.94|0.93|0.0313
91640869|NCT02163759|183173475|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
91640870|NCT02163759|183173476|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
91674183|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
91674184|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|4.5||||0.0586|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0586
91640871|NCT02163759|183173476|SUPERIORITY|||||||0.3374||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.3374
91485753|NCT00785928|182844670|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.992
91640872|NCT02163759|183173477|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
91640873|NCT02163759|183173478|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
91640874|NCT02163759|183173478|SUPERIORITY|||||||0.6367||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.6367
91640875|NCT02163759|183173479|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
91640876|NCT02163759|183173480|SUPERIORITY||Mean Difference (Net)|-0.7||||0.3708|TWO_SIDED|95.0|-2.4|0.9||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.9|-2.4|0.3708
91640877|NCT02163759|183173480|SUPERIORITY||Mean Difference (Net)|-0.5||||0.4477|TWO_SIDED|95.0|-1.8|0.8||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.8|-1.8|0.4477
91640878|NCT02163759|183173481|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
91674185|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
91485754|NCT00785928|182844670|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.646
91640879|NCT02163759|183173481|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
91485755|NCT00785928|182844670|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.054
91485756|NCT00785928|182844670|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.472
91485757|NCT00785928|182844671|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.952
91485758|NCT00785928|182844671|SUPERIORITY_OR_OTHER|||||||0.085||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.085
91640880|NCT02163759|183173482|SUPERIORITY||Mean Difference (Net)|-0.2||||0.6356|TWO_SIDED|95.0|-0.9|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.9|0.6356
91640881|NCT02163759|183173482|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1253|TWO_SIDED|95.0|-1.0|0.1||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.1|-1.0|0.1253
91640882|NCT02163759|183173483|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
91640883|NCT02163759|183173483|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
91674186|NCT03575871|183241861|SUPERIORITY||Difference in Percentage|6.3||||0.0244|TWO_SIDED|95.0|1.2|11.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.4|1.2|0.0244
91485759|NCT00785928|182844671|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.143
91485760|NCT00785928|182844671|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.242
91485761|NCT00785928|182844671|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.317
91640884|NCT02163759|183173484|SUPERIORITY||Difference in Remission Rates|10.9||||0.0364|TWO_SIDED|95.0|-0.08|19.48||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||19.48|-0.08|0.0364
91485762|NCT00785928|182844671|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.456
91485763|NCT00785928|182844672|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.833
91485764|NCT00785928|182844672|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.826
91485765|NCT00785928|182844672|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.091
91674187|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|25.0|||<|0.0001|TWO_SIDED|95.0|14.8|35.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.2|14.8|<0.0001
91793122|NCT02032823|183463950|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.0091|TWO_SIDED|98.5|0.468|0.973||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.973|0.468|0.0091
91793123|NCT02411448|183463987|OTHER||Hazard Ratio (HR)|0.591|||<|0.0001|TWO_SIDED|95.0|0.461|0.76|||Log Rank|||||0.760|0.461|<0.0001
91793124|NCT02411448|183463989|OTHER||Hazard Ratio (HR)|0.832||||0.4209|TWO_SIDED|95.0|0.532|1.303|||Log Rank|||||1.303|0.532|0.4209
91793125|NCT02411448|183463990|OTHER|||||||0.7413|||||||Cochran-Mantel-Haenszel|||||||0.7413
91793126|NCT02411448|183463991|OTHER|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
91793127|NCT02411448|183463992|OTHER||Hazard Ratio (HR)|0.619||||0.0003|TWO_SIDED|95.0|0.477|0.805|||Log Rank|||||0.805|0.477|0.0003
91485766|NCT00785928|182844672|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.127
91485767|NCT00785928|182844672|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.243
91485768|NCT00785928|182844672|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.037
91485769|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.562
91485770|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.539
91674188|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|44.2|||<|0.0001|TWO_SIDED|95.0|33.9|54.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||54.6|33.9|<0.0001
91674189|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|17.5|42.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.8|17.5|<0.0001
91674190|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|49.8|||<|0.0001|TWO_SIDED|95.0|37.8|61.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.7|37.8|<0.0001
91674191|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|31.5|||<|0.0001|TWO_SIDED|95.0|18.8|44.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.3|18.8|<0.0001
91793128|NCT04566666|183463999|SUPERIORITY|||||||0.1011|||||||Cochran-Mantel-Haenszel|||||||0.1011
91793129|NCT04566666|183463999|SUPERIORITY|||||||0.2666|||||||Cochran-Mantel-Haenszel|||||||0.2666
91793130|NCT04566666|183463999|SUPERIORITY|||||||0.7394|||||||Cochran-Mantel-Haenszel|||||||0.7394
91793131|NCT04566666|183464000|SUPERIORITY|||||||0.1376|||||||Cochran-Mantel-Haenszel|||||||0.1376
91793132|NCT04566666|183464000|SUPERIORITY|||||||0.1254|||||||Cochran-Mantel-Haenszel|||||||0.1254
91793133|NCT04566666|183464000|SUPERIORITY|||||||0.2349|||||||Cochran-Mantel-Haenszel|||||||0.2349
91793134|NCT04566666|183464002|SUPERIORITY||Binomial proportion|0.0|||||TWO_SIDED|95.0|0.0|7.3||||||The data represents the Statistical Analysis for PASI 100||7.3|0.0|
91793135|NCT04566666|183464002|SUPERIORITY||binomial proportion|3.4|||||TWO_SIDED|95.0|0.4|11.7||||||The data represents the Statistical Analysis for PASI 100||11.7|0.4|
91793136|NCT04566666|183464002|SUPERIORITY||binomial proportion|1.8|||||TWO_SIDED|1.8|0.0|9.4||||||The data represents the Statistical Analysis for PASI 100||9.4|0.0|
91793137|NCT04566666|183464002|SUPERIORITY||binomial proportion|2.2|||||TWO_SIDED|95.0|0.1|11.5||||||The data represents the Statistical Analysis for PASI 100||11.5|0.1|
91793138|NCT04566666|183464002|SUPERIORITY||binomial proportion|46.9|||||TWO_SIDED|95.0|32.5|61.7||||||The data represents the Statistical Analysis for PASI 50||61.7|32.5|
91793139|NCT04566666|183464002|SUPERIORITY||binomial proportion|47.5|||||TWO_SIDED|95.0|34.3|60.9||||||The data represents the Statistical Analysis for PASI 50||60.9|34.3|
91793140|NCT04566666|183464002|SUPERIORITY||binomial proportion|56.1|||||TWO_SIDED|95.0|42.4|69.3||||||The data represents the Statistical Analysis for PASI 50||69.3|42.4|
91793141|NCT04566666|183464002|SUPERIORITY||binomial proportion|50.0|||||TWO_SIDED|95.0|34.9|65.1||||||The data represents the Statistical Analysis for PASI 50||65.1|34.9|
91793142|NCT04566666|183464002|SUPERIORITY||binomial proportion|14.3|||||TWO_SIDED|95.0|5.9|27.2||||||The data represents the Statistical Analysis for PASI 75||27.2|5.9|
91640885|NCT02163759|183173484|SUPERIORITY||Difference in Remission Rates|-4.5||||0.3383|TWO_SIDED|95.0|-14.1|5.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||5.07|-14.10|0.3383
91640886|NCT02163759|183173485|SUPERIORITY||Difference in Remission Rates|6.2||||0.09|TWO_SIDED|95.0|-3.33|12.3||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||12.30|-3.33|0.0900
91640887|NCT02163759|183173485|SUPERIORITY||Difference in Remission Rates|-3.6||||0.3217|TWO_SIDED|95.0|-11.07|3.78||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||3.78|-11.07|0.3217
91640888|NCT02163759|183173486|SUPERIORITY||Difference in Adjusted Means|1.3||||0.7919|TWO_SIDED|95.0|-8.3|10.8||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.8|-8.3|0.7919
91640889|NCT02163759|183173486|SUPERIORITY||Difference in Adjusted Means|-0.8||||0.8327|TWO_SIDED|95.0|-8.7|7.0||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.0|-8.7|0.8327
91640890|NCT02883400|183173492|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91640891|NCT00333437|183173493|SUPERIORITY_OR_OTHER||Change from Baseline|0.1786|STANDARD_DEVIATION|0.1613||0.026|TWO_SIDED|95.0|0.0294|0.3277||Not adjusted|t-test, 2 sided|||H(0): post-pre FVC (liters) = 0||0.3277|0.0294|0.026
91640892|NCT00333437|183173494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.1035||0.3652|TWO_SIDED|95.0|-10.49|4.4945||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre neutrophil count = 0||4.4945|-10.49|0.3652
91640893|NCT00333437|183173494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.286|STANDARD_DEVIATION|16.358||0.3485|TWO_SIDED|95.0|-21.41|8.8426||significant p\<0.05|t-test, 2 sided|||H(0): post-pre eosinophil count = 0||8.8426|-21.41|0.3485
91640894|NCT00333437|183173496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|264.26|STANDARD_DEVIATION|194.66||0.0115|TWO_SIDED|95.0|84.256|444.32||Significant p\<0.05|t-test, 2 sided|Not adjusted||H(0): post-pre walk distance = 0||444.32|84.256|0.0115
91640895|NCT00333437|183173497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8643|STANDARD_DEVIATION|1.5013||0.0167|TWO_SIDED|95.0|0.4758|3.2527||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre DLCO = 0||3.2527|0.4758|0.0167
91640896|NCT03022526|183173498|SUPERIORITY|||||||0.7463|||||||t-test, 2 sided|||||||0.7463
91640897|NCT03022526|183173499|SUPERIORITY|||||||0.5764|||||||t-test, 2 sided|||||||0.5764
91640898|NCT03022526|183173500|SUPERIORITY|||||||0.7169|||||||t-test, 2 sided|||||||0.7169
91640899|NCT03022526|183173501|SUPERIORITY|||||||0.4226|||||||t-test, 2 sided|||||||0.4226
91640900|NCT03022526|183173502|SUPERIORITY|||||||0.6873|||||||t-test, 2 sided|||||||0.6873
91640901|NCT03022526|183173503|SUPERIORITY|||||||0.0452|||||||Chi-squared|||||||0.0452
91640902|NCT03022526|183173504|SUPERIORITY|||||||0.0899|||||||Chi-squared|||||||0.0899
91640903|NCT03022526|183173505|SUPERIORITY|||||||0.1265|||||||Chi-squared|||||||0.1265
91640904|NCT03022526|183173506|SUPERIORITY|||||||0.0328|||||||t-test, 2 sided|||||||0.0328
91640905|NCT03022526|183173507|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||||||0.6824
91640906|NCT03022526|183173508|SUPERIORITY|||||||0.449|||||||t-test, 2 sided|||||||0.449
91640907|NCT03022526|183173509|SUPERIORITY|||||||0.5996|||||||t-test, 2 sided|||||||0.5996
91640908|NCT03022526|183173510|SUPERIORITY|||||||0.8009|||||||t-test, 2 sided|||||||0.8009
91640909|NCT03022526|183173511|SUPERIORITY|||||||0.5422|||||||t-test, 2 sided|||||||0.5422
91640910|NCT03022526|183173512|SUPERIORITY|||||||0.7374|||||||t-test, 2 sided|||||||0.7374
91640911|NCT03315780|183173513|SUPERIORITY||Mean Difference (Final Values)|-254.02|||<|0.0001|TWO_SIDED|95.0|-337.76|-170.28|||Mixed Models Analysis|||||-170.28|-337.76|< 0.0001
91640912|NCT03315780|183173516|SUPERIORITY||Mean Difference (Final Values)|27.46||||0.01|TWO_SIDED|95.0|8.05|46.87|||Mixed Models Analysis|||||46.87|8.05|0.0100
91640913|NCT03315780|183173517|SUPERIORITY||Mean Difference (Final Values)|3.72||||0.0263|TWO_SIDED|95.0|0.63|6.81|||Mixed Models Analysis|||||6.81|0.63|0.0263
91674192|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|47.6|||<|0.0001|TWO_SIDED|95.0|35.7|59.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.6|35.7|<0.0001
91674193|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|48.7|||<|0.0001|TWO_SIDED|95.0|37.2|60.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.1|37.2|<0.0001
91674194|NCT03575871|183241862|SUPERIORITY||Difference in Percentage|60.1|||<|0.0001|TWO_SIDED|95.0|49.1|71.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.0|49.1|<0.0001
91674195|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|2.5||||0.1623|TWO_SIDED|95.0|-1.7|6.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.8|-1.7|0.1623
91674196|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|9.1||||0.007|TWO_SIDED|95.0|3.4|14.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.7|3.4|0.0070
91674197|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|9.7||||0.0049|TWO_SIDED|95.0|4.0|15.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.4|4.0|0.0049
91716662|NCT00526474|183325155|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.79|<0.001
91716663|NCT00526474|183325156|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.75|<0.001
91527861|NCT06173570|182930695|SUPERIORITY||Mean Difference (Net)|-4.06||||0.451|TWO_SIDED|95.0|-14.63|6.51|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||6.51|-14.63|0.451
91674198|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|22.9|||<|0.0001|TWO_SIDED|95.0|15.5|30.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.2|15.5|<0.0001
91674199|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|14.6||||0.0013|TWO_SIDED|95.0|7.2|22.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.0|7.2|0.0013
91674200|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|23.1|40.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.1|23.1|<0.0001
91674201|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|20.1||||0.0001|TWO_SIDED|95.0|11.9|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|11.9|0.0001
91674202|NCT03575871|183241863|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|24.6|42.5|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.6|<0.0001
91674203|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
91674204|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|1.3||||0.3261|TWO_SIDED|95.0|-2.8|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.8|0.3261
91674205|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.7|0.3207
91793143|NCT04566666|183464002|SUPERIORITY||binomial proportion|28.8|||||TWO_SIDED|95.0|17.8|42.1||||||The data represents the Statistical Analysis for PASI 75||42.1|17.8|
91793144|NCT04566666|183464002|SUPERIORITY||binomial proportion|26.3|||||TWO_SIDED|95.0|15.5|39.7||||||The data represents the Statistical Analysis for PASI 75||39.7|15.5|
91793145|NCT04566666|183464002|SUPERIORITY||binomial proportion|17.4|||||TWO_SIDED|95.0|7.8|31.4||||||The data represents the Statistical Analysis for PASI 75||31.4|7.8|
91640914|NCT03315780|183173518|SUPERIORITY||Mean Difference (Final Values)|-9.36||||0.08|TWO_SIDED|95.0|-20.16|1.43|||Mixed Models Analysis|||||1.43|-20.16|0.0800
91793146|NCT04566666|183464002|SUPERIORITY||binomial proportion|0.0|||||TWO_SIDED|95.0|0.0|7.3||||||The data represents the Statistical Analysis for PASI 90||7.3|0.0|
91674206|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|3.9||||0.081|TWO_SIDED|95.0|-0.8|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.8|0.0810
91674207|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
91793147|NCT04566666|183464002|SUPERIORITY||binomial proportion|6.8|||||TWO_SIDED|95.0|1.9|16.5||||||The data represents the Statistical Analysis for PASI 90||16.5|1.9|
91793148|NCT04566666|183464002|SUPERIORITY||binomial proportion|7.0|||||TWO_SIDED|95.0|1.9|17.0||||||The data represents the Statistical Analysis for PASI 90||17.0|1.9|
91793149|NCT04566666|183464002|SUPERIORITY||binomial proportion|2.2|||||TWO_SIDED|95.0|0.1|11.5||||||The data represents the Statistical Analysis for PASI 90||11.5|0.1|
91793150|NCT06379893|183464017|SUPERIORITY||Least Square Means|15.6|||<|0.001|TWO_SIDED|95.0|8.3|22.8|||MMRM|||Change From Baseline at Week 1||22.8|8.3|<0.001
91640915|NCT03315780|183173519|SUPERIORITY||Mean Difference (Final Values)|-15.39||||0.7475|TWO_SIDED|95.0|-118.35|87.57|||Mixed Models Analysis|||||87.57|-118.35|0.7475
91640916|NCT00451191|183173525|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Simon's optimal two-stage design|||Simon's optimal two-stage design was applied to determine whether there was sufficient activity at either of the two dose levels to warrant further investigation. Each patient was considered either a successful or failed response. The response rate or proportion of patients treated successfully was examined in two stages. At both stages, the two dose levels were compared to pre-determined critical cut-off values. Sample size was based on significance level α=0.05 and power 90%.||||<0.05
91640917|NCT00656669|183173534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of sunitinib monotherapy||From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.||||0.0001
91640918|NCT00656669|183173535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7963||||||a priori threshold of \<0.05|t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of paxlitaxel+sunitinib treatment||||||0.7963
91640919|NCT01241591|183173556|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% lower confidence intervals (LCIs) of the difference for PGA and Psoriasis Area and Severity Index 75 (PASI75) responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA response and PASI75 at Week 12.|Mean Difference|-19.16|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-26.55|-11.76||||||Difference from Etanercept (Active-Etanercept)||-11.76|-26.55|
91640920|NCT01241591|183173556|SUPERIORITY_OR_OTHER||Mean Difference|32.16|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|23.51|40.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.81|23.51|
91640921|NCT01241591|183173556|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|-5.22|9.05||||||Difference from Etanercept (Active-Etanercept)||9.05|-5.22|
91640922|NCT01241591|183173556|SUPERIORITY_OR_OTHER||Mean Difference|53.23|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|44.81|61.65||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||61.65|44.81|
91793151|NCT06379893|183464018|SUPERIORITY||Least Square Means|13.0||||0.001|TWO_SIDED|95.0|5.2|20.9|||MMRM|||Change From Baseline at Week 2||20.9|5.2|0.001
91793152|NCT06379893|183464019|SUPERIORITY||Least Square Means|2.1||||0.653|TWO_SIDED|95.0|-7.1|11.3|||MMRM|||Change From Baseline at Week 3||11.3|-7.1|0.653
91793153|NCT06379893|183464020|SUPERIORITY||Least Square Means|707.0||||0.001|TWO_SIDED|95.0|278.9|1135.0|||MMRM|||Change from Baseline at Week 1||1135|278.9|0.001
91793154|NCT06379893|183464020|SUPERIORITY||Least Square Means|487.3||||0.04|TWO_SIDED|95.0|22.0|952.6|||MMRM|||Change from Baseline at Week 2||952.6|22|0.040
91793155|NCT06379893|183464020|SUPERIORITY||Least Square Means|130.8||||0.603|TWO_SIDED|95.0|-365.6|627.2|||MMRM|||Change from Baseline at Week 3||627.2|-365.6|0.603
91793156|NCT06379893|183464021|SUPERIORITY||Least Square Means|-0.028||||0.473|TWO_SIDED|95.0|-0.105|0.049|||MMRM|||Change from Baseline at Week 1||0.049|-0.105|0.473
91793157|NCT06379893|183464021|SUPERIORITY||Least Square Means|0.009||||0.835|TWO_SIDED|95.0|-0.074|0.091|||MMRM|||Change from Baseline at Week 2||0.091|-0.074|0.835
91793158|NCT06379893|183464021|SUPERIORITY||Least Square Means|0.11||||0.014|TWO_SIDED|95.0|0.023|0.198|||MMRM|||Change from Baseline at Week 3||0.198|0.023|0.014
91793159|NCT06379893|183464022|SUPERIORITY||Least Square Means|0.261||||0.261|TWO_SIDED|95.0|-0.196|0.717|||MMRM|||Change from Baseline at Week 1||0.717|-0.196|0.261
91793160|NCT06379893|183464022|SUPERIORITY||Least Square Means|0.249||||0.263|TWO_SIDED|95.0|-0.188|0.685|||MMRM|||Change from Baseline at Week 2||0.685|-0.188|0.263
91640923|NCT01241591|183173557|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA and PASI75 response at Week 12.|Mean Difference|-19.29|STANDARD_ERROR_OF_MEAN|3.81|||TWO_SIDED|95.0|-26.75|-11.83||||||Difference from Etanercept (Active-Etanercept)||-11.83|-26.75|
91793161|NCT06379893|183464022|SUPERIORITY||Least Square Means|0.053||||0.854|TWO_SIDED|95.0|-0.512|0.617|||MMRM|||Change from Baseline at Week 3||0.617|-0.512|0.854
91485771|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.304
91640924|NCT01241591|183173557|SUPERIORITY_OR_OTHER||Mean Difference|33.91|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|27.06|40.76||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.76|27.06|
91640925|NCT01241591|183173557|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|4.83|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-2.57|12.23||||||Difference from Etanercept (Active-Etanercept)||12.23|-2.57|
91640926|NCT01241591|183173557|SUPERIORITY_OR_OTHER||Mean Difference|58.03|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|51.25|64.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||64.81|51.25|
91640927|NCT01945034|183173602|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0||||0.19|TWO_SIDED|95.0|-11.49|57.56||p-value \<=0.05 for treatment effects|ANOVA|||The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||57.56|-11.49|0.190
91640928|NCT01945034|183173602|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.633|TWO_SIDED|95.0|-24.2|39.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||39.70|-24.20|0.633
91640929|NCT01945034|183173602|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.436|TWO_SIDED|95.0|-53.87|23.3||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.||23.30|-53.87|0.436
91674208|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|3.8||||0.081|TWO_SIDED|95.0|-0.7|8.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.4|-0.7|0.0810
91640930|NCT01945034|183173603|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.8||||0.426|TWO_SIDED|95.0|-6.98|16.49||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||16.49|-6.98|0.426
91640931|NCT01945034|183173603|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.85|TWO_SIDED|95.0|-11.9|9.82||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||9.82|-11.90|0.850
91793162|NCT06379893|183464024|SUPERIORITY||Least Square Means|2415.2||||0.221|TWO_SIDED|95.0|-1466.3|6296.8|||MMRM|||Change from Baseline at Week 1||6296.8|-1466.3|0.221
91793163|NCT06379893|183464024|SUPERIORITY||Least Square Means|3041.7||||0.127|TWO_SIDED|95.0|-868.5|6951.9|||MMRM|||Change from Baseline at Week 2||6951.9|-868.5|0.127
91793164|NCT06379893|183464024|SUPERIORITY||Least Square Means|-2428.7||||0.314|TWO_SIDED|95.0|-7177.5|2320.1|||MMRM|||Change from Baseline at Week 3||2320.1|-7177.5|0.314
91793165|NCT06379893|183464025|SUPERIORITY||Least Square Means|3409.9||||0.289|TWO_SIDED|95.0|-2911.4|9731.2|||MMRM|||Change from Baseline at Week 1||9731.2|-2911.4|0.289
91793166|NCT06379893|183464025|SUPERIORITY||Least Square Means|3552.3||||0.303|TWO_SIDED|95.0|-3240.4|10345.1|||MMRM|||Change from Baseline at Week 2||10345.1|-3240.4|0.303
91793167|NCT06379893|183464025|SUPERIORITY||Least Square Means|-7820.7||||0.046|TWO_SIDED|95.0|-15512.8|-128.5|||MMRM|||Change from Baseline at Week 3||-128.5|-15512.8|0.046
91793168|NCT06379893|183464026|SUPERIORITY||Least Square Means|-8.392|||<|0.001|TWO_SIDED|95.0|-10.196|-6.588|||MMRM|||Change from Baseline at Week 1||-6.588|-10.196|<0.001
91793169|NCT06379893|183464026|SUPERIORITY||Least Square Means|-11.882|||<|0.001|TWO_SIDED|95.0|-13.946|-9.818|||MMRM|||Change from Baseline at Week 2||-9.818|-13.946|<0.001
91793170|NCT06379893|183464026|SUPERIORITY||Least Square Means|-15.929|||<|0.001|TWO_SIDED|95.0|-18.32|-13.537|||MMRM|||Change from Baseline at Week 3||-13.537|-18.320|<0.001
91674209|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
91674210|NCT03575871|183241864|SUPERIORITY||Difference in Percentage|7.0||||0.018|TWO_SIDED|95.0|1.8|12.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.2|1.8|0.0180
91674211|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-30.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-22.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-22.3|-38.1|<0.0001
91674212|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-42.3|||<|0.0001|TWO_SIDED|95.0|-50.3|-34.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-34.4|-50.3|<0.0001
91674213|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-29.9|||<|0.0001|TWO_SIDED|95.0|-38.1|-21.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.7|-38.1|<0.0001
91674214|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-44.6|||<|0.0001|TWO_SIDED|95.0|-52.8|-36.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.3|-52.8|<0.0001
91674215|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-36.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-36.2|<0.0001
91674216|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-40.2|||<|0.0001|TWO_SIDED|95.0|-50.0|-30.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-30.4|-50.0|<0.0001
91674217|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.1|-19.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-19.7|-43.1|<0.0001
91674218|NCT03575871|183241865|SUPERIORITY||Difference in LS mean|-44.7|||<|0.0001|TWO_SIDED|95.0|-56.4|-33.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-33.0|-56.4|<0.0001
91674219|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-17.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.5|-35.5|<0.0001
91674220|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-34.1|||<|0.0001|TWO_SIDED|95.0|-43.1|-25.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-25.1|-43.1|<0.0001
91674221|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-29.7|||<|0.0001|TWO_SIDED|95.0|-39.0|-20.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-20.4|-39.0|<0.0001
91674222|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-40.5|||<|0.0001|TWO_SIDED|95.0|-49.8|-31.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-31.1|-49.8|<0.0001
91674223|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.6|-21.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.2|-44.6|<0.0001
91674224|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-40.6|||<|0.0001|TWO_SIDED|95.0|-52.2|-28.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-28.9|-52.2|<0.0001
91674225|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-39.6|||<|0.0001|TWO_SIDED|95.0|-51.8|-27.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-27.4|-51.8|<0.0001
91674226|NCT03575871|183241866|SUPERIORITY||Difference in LS mean|-48.2|||<|0.0001|TWO_SIDED|95.0|-60.4|-36.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.0|-60.4|<0.0001
91793171|NCT06379893|183464029|SUPERIORITY||Least Square Means|-1.4|||<|0.001|TWO_SIDED|95.0|-1.7|-1.2|||MMRM|||Change from Baseline at Week 1||-1.2|-1.7|<0.001
91793172|NCT06379893|183464029|SUPERIORITY||Least Square Means|-2.0|||<|0.001|TWO_SIDED|95.0|-2.2|-1.7|||MMRM|||Change from Baseline at Week 2||-1.7|-2.2|<0.001
91793173|NCT06379893|183464029|SUPERIORITY||Least Square Means|-2.6|||<|0.001|TWO_SIDED|95.0|-2.9|-2.3|||MMRM|||Change from Baseline at Week 3||-2.3|-2.9|<0.001
91674227|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|1.9||||0.2353|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2353
91674228|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|5.8||||0.0332|TWO_SIDED|95.0|0.8|10.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.8|0.8|0.0332
91674229|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|6.5||||0.0227|TWO_SIDED|95.0|1.4|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.4|0.0227
91674230|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|16.8||||0.0001|TWO_SIDED|95.0|10.1|23.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.5|10.1|0.0001
91674231|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|14.5||||0.0008|TWO_SIDED|95.0|7.7|21.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.3|7.7|0.0008
91674232|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|25.8|||<|0.0001|TWO_SIDED|95.0|18.1|33.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.4|18.1|<0.0001
91793174|NCT06379893|183464030|SUPERIORITY||Least Square Means|-26.529|||<|0.001|TWO_SIDED|95.0|-31.929|-21.129|||MMRM|||Change From Baseline at Week 1||-21.129|-31.929|<0.001
91640932|NCT01945034|183173603|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8||||0.385|TWO_SIDED|95.0|-18.91|7.32||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.||7.32|-18.91|0.385
91640933|NCT01945034|183173604|SUPERIORITY_OR_OTHER||LS Mean Difference|10.0||||0.072|TWO_SIDED|95.0|-0.92|20.91||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||20.91|-0.92|0.072
91640934|NCT01945034|183173604|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.296|TWO_SIDED|95.0|-15.4|4.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.70|-15.40|0.296
91640935|NCT01945034|183173604|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.014|TWO_SIDED|95.0|-27.53|-3.16||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.||-3.16|-27.53|0.014
91640936|NCT01945034|183173605|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.305|TWO_SIDED|95.0|-0.1|0.3||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo||0.30|-0.10|0.305
91674233|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|18.5||||0.0003|TWO_SIDED|95.0|10.5|26.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||26.5|10.5|0.0003
91674234|NCT03575871|183241867|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|21.4|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.4|<0.0001
91674235|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|12.7||||0.0011|TWO_SIDED|95.0|6.5|18.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.9|6.5|0.0011
91674236|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.6|40.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.6|24.6|<0.0001
91793175|NCT06379893|183464030|SUPERIORITY||Least Square Means|-36.179|||<|0.001|TWO_SIDED|95.0|-42.09|-30.269|||MMRM|||Change From Baseline at Week 2||-30.269|-42.090|<0.001
91793176|NCT06379893|183464030|SUPERIORITY||Least Square Means|-48.834|||<|0.001|TWO_SIDED|95.0|-55.692|-41.976|||MMRM|||Change From Baseline at Week 3||-41.976|-55.692|<0.001
91793177|NCT06379893|183464031|SUPERIORITY||Least Square Means|-9.213|||<|0.001|TWO_SIDED|95.0|-11.011|-7.415|||MMRM|||Change from Baseline at Week 1||-7.415|-11.011|<0.001
91793178|NCT06379893|183464031|SUPERIORITY||Least Square Means|-12.57|||<|0.001|TWO_SIDED|95.0|-14.519|-10.621|||MMRM|||Change from Baseline at Week 2||-10.621|-14.519|<0.001
91793179|NCT06379893|183464031|SUPERIORITY||Least Square Means|-16.408|||<|0.001|TWO_SIDED|95.0|-18.669|-14.146|||MMRM|||Change from Baseline at Week 3||-14.146|-18.669|<0.001
91640937|NCT01945034|183173605|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.261|TWO_SIDED|95.0|-0.08|0.29||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.29|-0.08|0.261
91640938|NCT01945034|183173605|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.22|0.22||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.22|-0.22|0.996
91527862|NCT06173570|182930695|SUPERIORITY||Mean Difference (Net)|-4.97||||0.351|TWO_SIDED|95.0|-15.41|5.47|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||5.47|-15.41|0.351
91640939|NCT01945034|183173605|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.21|TWO_SIDED|95.0|-0.08|0.36||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.08|0.210
91640940|NCT01945034|183173605|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.556|TWO_SIDED|95.0|-0.14|0.27||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.27|-0.14|0.556
91640941|NCT01945034|183173605|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.534|TWO_SIDED|95.0|-0.33|0.17||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.17|-0.33|0.534
91640942|NCT01945034|183173606|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.354|TWO_SIDED|95.0|-0.27|0.1||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.10|-0.27|0.354
91640943|NCT01945034|183173606|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.237|TWO_SIDED|95.0|-0.28|0.07||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.07|-0.28|0.237
91640944|NCT01945034|183173606|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.871|TWO_SIDED|95.0|-0.23|0.19||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.19|-0.23|0.871
91640945|NCT01945034|183173606|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.05|TWO_SIDED|95.0|-0.43|0.0||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.00|-0.43|0.050
91640946|NCT01945034|183173606|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.64|TWO_SIDED|95.0|-0.25|0.15||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.25|0.640
91674237|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|28.3|||<|0.0001|TWO_SIDED|95.0|18.5|38.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.2|18.5|<0.0001
91674238|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|43.2|<0.0001
91640947|NCT01945034|183173606|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.18|TWO_SIDED|95.0|-0.08|0.41||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.41|-0.08|0.180
91640948|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.771|TWO_SIDED|95.0|-0.38|0.51|||ANOVA|||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.51|-0.38|0.771
91640949|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-0.88|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.07|-0.88|0.022
91640950|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.032|TWO_SIDED|95.0|-1.03|-0.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.05|-1.03|0.032
91793180|NCT06379893|183464032|SUPERIORITY||Least Square Means|-8.912|||<|0.001|TWO_SIDED|95.0|-11.401|-6.423|||MMRM|||Change from Baseline at Week 1||-6.423|-11.401|<0.001
91793181|NCT06379893|183464032|SUPERIORITY||Least Square Means|-11.699|||<|0.001|TWO_SIDED|95.0|-14.177|-9.221|||MMRM|||Change from Baseline at Week 2||-9.221|-14.177|<0.001
91674239|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|17.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|17.0|<0.0001
91526477|NCT03573908|182928120|SUPERIORITY||Hodges-Lehman Estimated Median Threshold|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.88|-0.35|||Wilcoxon Rank Sum Test|P-value comparing change from baseline distributions by treatment using the Wilcoxon rank sum test 2-sided.|95% confidence interval (CI) for Hodges-Lehmann estimated median threshold was generated by Moses confidence limits method.|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.35|-0.88|< 0.0001
91526478|NCT03573908|182928121|SUPERIORITY||Difference in Responder Rate|17.1|||||TWO_SIDED|95.0|9.9|24.4|||||95% confidence intervals for difference in responder rate are obtained using the normal approximation to the binomial distribution.|||24.4|9.9|
91526479|NCT03573908|182928121|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.0001|TWO_SIDED|95.0|1.55|3.12||Odds ratio, 95% CI for the Odds Ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for geographic region.|Cochran-Mantel-Haenszel|||The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||3.12|1.55|< 0.0001
91526480|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.219|-0.515||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 12. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.515|-1.219|< 0.0001
91526481|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.719|||<|0.0001|TWO_SIDED|95.0|-1.062|-0.376||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 10. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.376|-1.062|< 0.0001
91526482|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.665||||0.0002|TWO_SIDED|95.0|-1.007|-0.322||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 8. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.322|-1.007|0.0002
91526483|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.831|||<|0.0001|TWO_SIDED|95.0|-1.151|-0.511||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 6. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.511|-1.151|< 0.0001
91526484|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.982|-0.383||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 4. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.383|-0.982|< 0.0001
91526485|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.628|||<|0.0001|TWO_SIDED|95.0|-0.888|-0.368||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 2. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.368|-0.888|< 0.0001
91793182|NCT06379893|183464032|SUPERIORITY||Least Square Means|-16.166|||<|0.001|TWO_SIDED|95.0|-18.858|-13.473|||MMRM|||Change from Baseline at Week 3||-13.473|-18.858|<0.001
91793183|NCT06379893|183464033|SUPERIORITY||Least Square Means|-0.1||||0.237|TWO_SIDED|95.0|-0.3|0.1|||MMRM|||Change from Baseline at Day 7||0.1|-0.3|0.237
91793184|NCT06379893|183464033|SUPERIORITY||Least Square Means|-0.2||||0.071|TWO_SIDED|95.0|-0.4|0.0|||MMRM|||Change from Baseline at Day 14||0.0|-0.4|0.071
91793185|NCT06379893|183464033|SUPERIORITY||Least Square Means|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||MMRM|||Change from Baseline at Day 21||-0.2|-0.6|<0.001
91793186|NCT06379893|183464034|SUPERIORITY||Least Square Means|0.04|||<|0.001|TWO_SIDED|95.0|0.02|0.05|||MMRM|||Change from Baseline at Day 7||0.05|0.02|<0.001
91793187|NCT06379893|183464034|SUPERIORITY||Least Square Means|0.05|||<|0.001|TWO_SIDED|95.0|0.04|0.07|||MMRM|||Change from Baseline at Day 14||0.07|0.04|<0.001
91640951|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.38|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.38|0.720
91640952|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.194|TWO_SIDED|95.0|-0.71|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.71|0.194
91640953|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.163|TWO_SIDED|95.0|-0.89|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.15|-0.89|0.163
91640954|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.644|TWO_SIDED|95.0|-0.4|0.64|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.64|-0.40|0.644
91640955|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.129|TWO_SIDED|95.0|-0.85|0.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.11|-0.85|0.129
91640956|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.096|TWO_SIDED|95.0|-1.07|0.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.09|-1.07|0.096
91640957|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.5|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.57|-0.50|0.905
91640958|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.279|TWO_SIDED|95.0|-0.77|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.77|0.279
91640959|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.315|TWO_SIDED|95.0|-0.9|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.29|-0.90|0.315
91640960|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.203|TWO_SIDED|95.0|-0.19|0.91|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.91|-0.19|0.203
91640961|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.207|TWO_SIDED|95.0|-0.83|0.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.18|-0.83|0.207
91640962|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.03|TWO_SIDED|95.0|-1.3|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.07|-1.30|0.030
91793188|NCT06379893|183464034|SUPERIORITY||Least Square Means|0.07|||<|0.001|TWO_SIDED|95.0|0.05|0.09|||MMRM|||Change from Baseline at Day 21||0.09|0.05|<0.001
91793189|NCT02616562|183464066|OTHER||Estimated Treatment difference|-3.66|||||TWO_SIDED|95.0|-5.57|-1.76||||||The primary analysis tested the estimated treatment difference in HV after 26 weeks of treatment between once-weekly somapacitan 0.04 mg/kg and daily dosing of norditropin 0.034 mg/kg. It was analysed using a mixed model for repeated measurements, with treatment, age group, sex, region and sex by age group interaction as factors and height at baseline as a covariate, all nested within week as a factor.||-1.76|-5.57|
91793190|NCT02616562|183464066|OTHER||Estimated treatment difference|-0.55|||||TWO_SIDED|95.0|-2.41|1.32||||||The primary analysis tested the estimated treatment difference in HV after 26 weeks of treatment between once-weekly somapacitan 0.08 mg/kg and daily dosing of norditropin 0.034 mg/kg. It was analysed using a mixed model for repeated measurements, with treatment, age group, sex, region and sex by age group interaction as factors and height at baseline as a covariate, all nested within week as a factor.||1.32|-2.41|
91793191|NCT02616562|183464066|OTHER||Estimated treatment difference|1.67|||||TWO_SIDED|95.0|-0.22|3.56||||||The primary analysis tested the estimated treatment difference in HV after 26 weeks of treatment between once-weekly somapacitan 0.16 mg/kg and daily dosing of norditropin 0.034 mg/kg. It was analysed using a mixed model for repeated measurements, with treatment, age group, sex, region and sex by age group interaction as factors and height at baseline as a covariate, all nested within week as a factor.||3.56|-0.22|
91526486|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.435|||<|0.0001|TWO_SIDED|95.0|-0.641|-0.228||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 1. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.228|-0.641|< 0.0001
91793192|NCT04770779|183464085|SUPERIORITY||Common Risk Difference on Response Rate|17.6||||0.0003|TWO_SIDED|95.0|8.0|27.2|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||27.2|8.0|0.0003
91526487|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.398||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 3. Not part of the fixed-sequence testing procedure.||-0.398|-0.969|< 0.0001
91526488|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.768|||<|0.0001|TWO_SIDED|95.0|-1.076|-0.46||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 5. Not part of the fixed-sequence testing procedure.||-0.460|-1.076|< 0.0001
91526489|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.758|||<|0.0001|TWO_SIDED|95.0|-1.086|-0.431||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 7. Not part of the fixed-sequence testing procedure.||-0.431|-1.086|< 0.0001
91526490|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.043|-0.363||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 9. Not part of the fixed-sequence testing procedure.||-0.363|-1.043|< 0.0001
91526491|NCT03573908|182928122|SUPERIORITY||LS mean difference|-0.844|||<|0.0001|TWO_SIDED|95.0|-1.189|-0.498||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 11. Not part of the fixed-sequence testing procedure.||-0.498|-1.189|< 0.0001
91526492|NCT04006925|182928123|OTHER||Median Difference (Net)|-23.5||||0.03|TWO_SIDED|95.0|-41.0|-2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||-2.0|-41.0|0.03
91526493|NCT04006925|182928123|OTHER||Median Difference (Net)|-9.0||||0.11|TWO_SIDED|95.0|-21.5|0.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-21.5|0.11
91526494|NCT04006925|182928123|SUPERIORITY||Median Difference (Net)|-14.5||||0.27|TWO_SIDED|95.0|-32.0|11.3||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||11.3|-32.0|0.27
91526495|NCT04006925|182928124|OTHER||Median Difference (Net)|-1.0||||0.02|TWO_SIDED|95.0|-3.0|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-3.0|0.02
91526496|NCT04006925|182928124|OTHER||Median Difference (Net)|0.0||||0.83|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||1.0|-1.0|0.83
91526497|NCT04006925|182928124|SUPERIORITY||Median Difference (Net)|-1.0||||0.09|TWO_SIDED|95.0|-3.5|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||0.0|-3.5|0.09
91526498|NCT04006925|182928125|SUPERIORITY|||||||0.08||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.08
91526499|NCT04006925|182928126|SUPERIORITY|||||||0.18||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.18
91526500|NCT04006925|182928127|OTHER||Median Difference (Net)|-1.0||||0.26|TWO_SIDED|95.0|-7.0|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-7.0|0.26
91526501|NCT04006925|182928127|OTHER||Median Difference (Final Values)|-0.5||||0.43|TWO_SIDED|95.0|-3.5|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-3.5|0.43
91526502|NCT04006925|182928127|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.65|TWO_SIDED|95.0|-4.0|3.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||3.0|-4.0|0.65
91526503|NCT04006925|182928128|OTHER||Mean Difference (Net)|-6.2||||0.23|TWO_SIDED|95.0|-15.2|1.7||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||1.7|-15.2|0.23
91526504|NCT04006925|182928128|OTHER||Mean Difference (Net)|0.2||||0.95|TWO_SIDED|95.0|-4.6|4.5||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||4.5|-4.6|0.95
91526505|NCT04006925|182928128|SUPERIORITY||Mean Difference (Net)|-6.4||||0.22|TWO_SIDED|95.0|-16.2|3.1||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Paired T-test|||Between group analysis of change from baseline.||3.1|-16.2|0.22
91674240|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|46.1|||<|0.0001|TWO_SIDED|95.0|35.2|57.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||57.1|35.2|<0.0001
91793193|NCT04770779|183464086|SUPERIORITY||Common Risk Difference on Response Rate|11.1||||0.0003|TWO_SIDED|95.0|5.1|17.0|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||17.0|5.1|0.0003
91793194|NCT04770779|183464087|SUPERIORITY||Common Risk Difference on Response Rate|13.4|||<|0.0001|TWO_SIDED|95.0|7.7|19.1|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||19.1|7.7|<0.0001
91485772|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.832
91640963|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.372|TWO_SIDED|95.0|-0.32|0.84|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.84|-0.32|0.372
91640964|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.532|TWO_SIDED|95.0|-0.7|0.36|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.70|0.532
91640965|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.189|TWO_SIDED|95.0|-1.08|0.21|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.21|-1.08|0.189
91640966|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.264|TWO_SIDED|95.0|-0.24|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.24|0.264
91640967|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.81|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.81|0.260
91640968|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.054|TWO_SIDED|95.0|-1.23|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.23|0.054
91640969|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.456|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.37|0.456
91640970|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.639|TWO_SIDED|95.0|-0.42|0.68|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.42|0.639
91640971|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.78|TWO_SIDED|95.0|-0.75|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.75|0.780
91640972|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.071|TWO_SIDED|95.0|-0.04|1.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.07|-0.04|0.071
91674241|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|36.2|||<|0.0001|TWO_SIDED|95.0|25.4|47.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.1|25.4|<0.0001
91793195|NCT04770779|183464088|SUPERIORITY||Common Risk Difference on Response Rate|6.4||||0.0056|TWO_SIDED|95.0|1.9|10.9|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||10.9|1.9|0.0056
91640973|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.468|TWO_SIDED|95.0|-0.7|0.32|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.32|-0.70|0.468
91640974|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.027|TWO_SIDED|95.0|-1.33|-0.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.08|-1.33|0.027
91640975|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.107|TWO_SIDED|95.0|-0.11|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.11|0.107
91640976|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.57|0.53|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.57|0.947
91674242|NCT03575871|183241868|SUPERIORITY||Difference in Percentage|49.6|||<|0.0001|TWO_SIDED|95.0|38.9|60.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.3|38.9|<0.0001
91674243|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|1.9||||0.2261|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2261
91674244|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|5.2||||0.0451|TWO_SIDED|95.0|0.3|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.3|0.0451
91674245|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|7.0||||0.0171|TWO_SIDED|95.0|1.8|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.8|0.0171
91674246|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|17.7|||<|0.0001|TWO_SIDED|95.0|10.9|24.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.5|10.9|<0.0001
91674247|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|11.5||||0.0018|TWO_SIDED|95.0|5.5|17.5||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.5|5.5|0.0018
91674248|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.1|18.3|<0.0001
91674249|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|16.2||||0.0005|TWO_SIDED|95.0|8.8|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|8.8|0.0005
91674250|NCT03575871|183241869|SUPERIORITY||Difference in Percentage|27.6|||<|0.0001|TWO_SIDED|95.0|19.3|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|19.3|<0.0001
91674251|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
91674252|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.3|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.5|<0.0001
91674253|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.3|-2.6|<0.0001
91674254|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-3.1|||<|0.0001|TWO_SIDED|95.0|-3.8|-2.5|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.5|-3.8|<0.0001
91674255|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
91674256|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.9|-3.3|<0.0001
91674257|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-1.4||||0.0006|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.6|-2.2|0.0006
91674258|NCT03575871|183241870|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.4|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.4|-3.0|<0.0001
91674259|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.8|-2.0|<0.0001
91793196|NCT03692052|183464113|OTHER||||||<|0.0001|||||||Clopper-Pearson Method|Significance of p-value associated with the test of H0:Hb response rate =0.3 vs H1:Hb response rate \> 0.3.||||||<.0001
91793197|NCT05169567|183464164|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.57|0.95|||Log Rank|||||0.95|0.57|0.02
91526506|NCT01755143|182928132|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|97.5|97.7|||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI \<90%.|||97.7|<0.0001
91640977|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.134|TWO_SIDED|95.0|-1.18|0.16|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.16|-1.18|0.134
91640978|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.017|TWO_SIDED|95.0|0.12|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.12|0.017
91640979|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.715|TWO_SIDED|95.0|-0.6|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.41|-0.60|0.715
91640980|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.015|TWO_SIDED|95.0|-1.39|-0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.15|-1.39|0.015
91640981|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.027|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.027
91640982|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.66|TWO_SIDED|95.0|-0.42|0.65|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.65|-0.42|0.660
91640983|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.107|TWO_SIDED|95.0|-1.18|0.11|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.11|-1.18|0.107
91640984|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|0.10|0.020
91674260|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.8|-3.0|<0.0001
91674261|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.2|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.2|-2.4|<0.0001
91793198|NCT04576455|183464180|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1757|TWO_SIDED|95.0|0.6|1.1|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.10|0.60|0.1757
91640985|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.749|TWO_SIDED|95.0|-0.55|0.4|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.55|0.749
91674262|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.6|<0.0001
91674263|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
91793199|NCT04576455|183464181|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3446|TWO_SIDED|95.0|0.85|1.6|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.60|0.85|0.3446
91793200|NCT04576455|183464182|SUPERIORITY||Odds Ratio (OR)|1.87||||0.1126|TWO_SIDED|95.0|0.86|4.07|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||4.07|0.86|0.1126
91793201|NCT04576455|183464182|SUPERIORITY||Difference in Objective Response Rates|5.35|||||TWO_SIDED|95.0|-1.97|12.78|||||Giredestrant vs. PCET|||12.78|-1.97|
91640986|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.27|-0.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.12|-1.27|0.019
91640987|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.163|TWO_SIDED|95.0|-0.16|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.16|0.163
91640988|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.727|TWO_SIDED|95.0|-0.43|0.61|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.61|-0.43|0.727
91640989|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.336|TWO_SIDED|95.0|-0.94|0.32|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.32|-0.94|0.336
91640990|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.174|TWO_SIDED|95.0|-0.16|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.16|0.174
91640991|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.277|TWO_SIDED|95.0|-0.73|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.21|-0.73|0.277
91640992|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.035|TWO_SIDED|95.0|-1.19|-0.04|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.04|-1.19|0.035
91640993|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.858|TWO_SIDED|95.0|-0.5|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.50|0.858
91640994|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.724|TWO_SIDED|95.0|-0.6|0.42|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.60|0.724
91640995|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.651|TWO_SIDED|95.0|-0.76|0.48|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.48|-0.76|0.651
91640996|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.059|TWO_SIDED|95.0|-0.02|1.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.05|-0.02|0.059
91640997|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.766|TWO_SIDED|95.0|-0.57|0.42|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.57|0.766
91640998|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.053|TWO_SIDED|95.0|-1.19|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.19|0.053
91674264|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.7|-3.1|<0.0001
91793202|NCT04576455|183464184|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0289|TWO_SIDED|95.0|1.06|3.04|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||3.04|1.06|0.0289
91526507|NCT01755143|182928133|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
91793203|NCT04576455|183464184|SUPERIORITY||Difference in Clinical Benefit Rates|10.74|||||TWO_SIDED|95.0|0.33|20.86|||||Giredestrant vs. PCET|||20.86|0.33|
91640999|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.212|TWO_SIDED|95.0|-0.21|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.21|0.212
91641000|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.49|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.49|0.911
91641001|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.305|TWO_SIDED|95.0|-0.96|0.3|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.30|-0.96|0.305
91641002|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.02|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.05|0.075
91485773|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.010
91485774|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.980
91674265|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-0.9||||0.0164|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.2|-1.7|0.0164
91674266|NCT03575871|183241871|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.0|-2.5|<0.0001
91674267|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-20.9|||<|0.0001|TWO_SIDED|95.0|-26.6|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-26.6|<0.0001
91674268|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-32.1|||<|0.0001|TWO_SIDED|95.0|-37.9|-26.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.4|-37.9|<0.0001
91674269|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-21.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-15.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.2|-28.1|<0.0001
91674270|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-35.9|||<|0.0001|TWO_SIDED|95.0|-42.3|-29.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-29.4|-42.3|<0.0001
91674271|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-19.4|||<|0.0001|TWO_SIDED|95.0|-26.8|-12.1|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-12.1|-26.8|<0.0001
91674272|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-33.6|||<|0.0001|TWO_SIDED|95.0|-41.0|-26.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.3|-41.0|<0.0001
91674273|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-23.1|||<|0.0001|TWO_SIDED|95.0|-32.3|-13.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.9|-32.3|<0.0001
91674274|NCT03575871|183241872|SUPERIORITY||Difference in LS mean|-33.4|||<|0.0001|TWO_SIDED|95.0|-42.6|-24.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-24.3|-42.6|<0.0001
91674275|NCT01746264|183241889|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||P-value for change from baseline to 3 month follow-up.||||0.59
91674276|NCT01746264|183241890|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow up visit.||||<0.001
91674277|NCT01746264|183241891|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||<0.01
91674278|NCT01746264|183241893|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
91674279|NCT01746264|183241894|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3-month follow-up.||||0.21
91674280|NCT01746264|183241895|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.02
91674281|NCT01746264|183241896|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.0123
91674282|NCT01746264|183241897|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.09
91674283|NCT01746264|183241898|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.27
91674284|NCT01746264|183241899|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.18
91674285|NCT01746264|183241900|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.33
91674286|NCT01746264|183241901|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.05
91674287|NCT01746264|183241902|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.41
91674288|NCT01746264|183241903|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
91674289|NCT01746264|183241904|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.47
91716664|NCT00526474|183325157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.77|<0.001
91793204|NCT04576455|183464185|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.061|TWO_SIDED|95.0|0.35|1.03|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 mutation detected at baseline||1.03|0.35|0.0610
91526508|NCT01755143|182928134|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|-0.7|||<|0.0001|TWO_SIDED|95.0|-5.4|4.1||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||4.1|-5.4|<0.0001
91641003|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.684|TWO_SIDED|95.0|-0.39|0.6|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.39|0.684
91641004|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.208|TWO_SIDED|95.0|-0.98|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.21|-0.98|0.208
91641005|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.27|0.85|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.85|-0.27|0.304
91641006|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.356|TWO_SIDED|95.0|-0.27|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.27|0.356
91641007|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.876|TWO_SIDED|95.0|-0.67|0.58|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.58|-0.67|0.876
91641008|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.15|0.10|0.020
91641009|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.47|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.47|-0.50|0.940
91641010|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.032|TWO_SIDED|95.0|-1.23|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.23|0.032
91674290|NCT02791893|183241905|SUPERIORITY|||||||0.47||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.47
91674291|NCT02791893|183241905|SUPERIORITY|||||||0.58||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase are not included limiting the sample to 10 subjects in each condition (N=20). Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.58
91674292|NCT02791893|183241906|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.||"A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase were assigned a score of 1 indicating no change in their condition. Post-intervention PGIC scores were compared between conditions."||||0.23
91674293|NCT02791893|183241906|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.23|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.|Condition difference = Active - Sham|Below are the results of the per protocol analysis. Post-intervention PGIC scores were compared between conditions.||||0.23
91641011|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.206|TWO_SIDED|95.0|-0.21|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.21|0.206
91641012|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.31|TWO_SIDED|95.0|-0.26|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.26|0.310
91641013|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.771|TWO_SIDED|95.0|-0.74|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.55|-0.74|0.771
91641014|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.24|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.24|0.13|0.016
91485775|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.569
91641015|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.48|0.54|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.54|-0.48|0.905
91641016|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.039|TWO_SIDED|95.0|-1.28|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.28|0.039
91641017|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.276|TWO_SIDED|95.0|-0.27|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.27|0.276
91641018|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.343|TWO_SIDED|95.0|-0.29|0.82|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.82|-0.29|0.343
91641019|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.849|TWO_SIDED|95.0|-0.73|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.60|-0.73|0.849
91641020|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.009|TWO_SIDED|95.0|0.19|1.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.29|0.19|0.009
91641021|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.763|TWO_SIDED|95.0|-0.58|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.43|-0.58|0.763
91641022|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.01|TWO_SIDED|95.0|-1.43|-0.2|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.20|-1.43|0.010
91641023|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.105|TWO_SIDED|95.0|-0.1|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.10|0.105
91674294|NCT02791893|183241907|SUPERIORITY||Mean Difference (Final Values)|12.88||||0.13|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.13
91674295|NCT02791893|183241907|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.12|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.12
91485776|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.953
91641024|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.533|TWO_SIDED|95.0|-0.38|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.38|0.533
91641025|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.348|TWO_SIDED|95.0|-0.99|0.35|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.35|-0.99|0.348
91641026|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.13|0.016
91716665|NCT00526474|183325158|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
91793205|NCT04576455|183464185|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5947|TWO_SIDED|95.0|0.54|1.42|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 Mutation not detected at baseline||1.42|0.54|0.5947
91793206|NCT04576455|183464186|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||Giredestrant vs. PCET|||1.40|0.58|
91793207|NCT04576455|183464187|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.12|||||Giredestrant vs. PCET|||1.12|0.49|
91526509|NCT01755143|182928135|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|1.6|||<|0.0001|ONE_SIDED|95.0|-3.2|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-3.2|<0.0001
91526510|NCT01755143|182928136|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9|||exact test of binomial proportions|A priori threshold for statistical significance was 0.05.||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
91641027|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.483|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.33|-0.69|0.483
91641028|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.006|TWO_SIDED|95.0|-1.47|-0.25|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.25|-1.47|0.006
91641029|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.177|TWO_SIDED|95.0|-0.19|1.0|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.00|-0.19|0.177
91641030|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.586|TWO_SIDED|95.0|-0.4|0.7|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.70|-0.40|0.586
91641031|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.448|TWO_SIDED|95.0|-0.92|0.41|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.41|-0.92|0.448
91641032|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.043|TWO_SIDED|95.0|0.02|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|0.02|0.043
91641033|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.688|TWO_SIDED|95.0|-0.59|0.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.39|-0.59|0.688
91641034|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.032|TWO_SIDED|95.0|-1.25|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.25|0.032
91641035|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.179|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.99|-0.19|0.179
91641036|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.40|0.609
91641037|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.435|TWO_SIDED|95.0|-0.92|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.40|-0.92|0.435
91793208|NCT04576455|183464188|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.35|||||Giredestrant vs. PCET|||1.35|0.53|
91793209|NCT04576455|183464189|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.72|1.69|||||Giredestrant vs. PCET|||1.69|0.72|
91641038|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.023|TWO_SIDED|95.0|0.1|1.26|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.26|0.10|0.023
91793210|NCT04576455|183464190|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.47|1.18|||||Giredestrant vs. PCET|||1.18|0.47|
91793211|NCT04449055|183464196|SUPERIORITY||chi-square|1.8311||||0.176|TWO_SIDED||||||Log Rank|||Log-rank test||||0.1760
91716666|NCT00526474|183325159|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88|||<|0.001|TWO_SIDED|95.0|0.83|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.83|<0.001
91716667|NCT00526474|183325160|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.108|TWO_SIDED|95.0|0.71|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.71|0.108
91716668|NCT00526474|183325161|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.002|TWO_SIDED|95.0|0.73|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.73|0.002
91716669|NCT00526474|183325162|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.127|TWO_SIDED|95.0|0.74|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.74|0.127
91716670|NCT00526474|183325163|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.87|0.52|0.002
91716671|NCT00526474|183325164|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.249|TWO_SIDED|95.0|0.8|1.06|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.06|0.80|0.249
91716672|NCT00526474|183325165|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.019|TWO_SIDED|95.0|0.76|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.76|0.019
91716673|NCT00526474|183325166|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.83|0.003
91716674|NCT00386334|183325167|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716675|NCT00386334|183325170|SUPERIORITY_OR_OTHER|||||||0.0014||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0014
91716676|NCT00386334|183325173|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91793212|NCT04449055|183464197|SUPERIORITY||chi-square|0.8||||0.3711|TWO_SIDED||||||Log Rank||Median and mean survival times were not estimable due to the small number of dropouts. Thus, we reported the proportion remaining in treatment at 18 days as the descriptive summary measure.|The null hypothesis is that time to discontinuation of psychosocial treatment is not different between groups.||||0.3711
91526511|NCT01755143|182928137|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.2||||0.0004|ONE_SIDED|95.0|-4.8||||Farrington-Manning test|A priori threshold for statistical significance was 0.05.||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.8|0.0004
91716677|NCT00386334|183325176|SUPERIORITY_OR_OTHER|||||||0.0005||||||Multiple comparisons not applied due to only two treatments in study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0005
91716678|NCT00386334|183325179|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716679|NCT00386334|183325182|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716680|NCT00386334|183325185|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716681|NCT00386334|183325188|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716682|NCT00386334|183325191|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716683|NCT00386334|183325194|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716684|NCT00386334|183325197|SUPERIORITY_OR_OTHER|||||||0.1175||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.1175
91793213|NCT04449055|183464197|SUPERIORITY||chi-square|0.8||||0.3711|||||||Log Rank|||This test compared time to discontinuation of psychosocial treatment between groups||||0.3711
91793214|NCT04449055|183464198|SUPERIORITY|Exact Wilcoxon rank-sum test comparing changes in temporal correlations between intervention groups.|Difference in median change|-0.711789||||0.1333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value reported as difference in median change from baseline to 4 weeks for the MPFC first group minus the median change from baseline to 4-weeks for the DPFC first group.|||||0.1333
91793215|NCT04449055|183464199|SUPERIORITY||Difference in median change|0.2729394||||0.1333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank-sum test of comparing changes in correlations between intervention groups.|Reported as difference in median change from baseline to 4 weeks for the MPFC first group minus median change for from baseline to 4-weeks for the DPFC first group.|||||0.1333
91526512|NCT02906683|182928139|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|6.8||0.329|TWO_SIDED|95.0|-20.1|6.7|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.7|-20.1|0.329
91674296|NCT02791893|183241908|SUPERIORITY||Mean Difference (Final Values)|-5.71||||0.58|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.58
91674297|NCT02791893|183241908|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.49|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.49
91674298|NCT02791893|183241909|SUPERIORITY||Mean Difference (Final Values)|-1.42||||0.18|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.18
91674299|NCT02791893|183241909|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.25
91674300|NCT02791893|183241910|SUPERIORITY|||||||0.004||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was a dependent t-test comparing pre-intervention scores to the scores collected at the end of the open label phase.||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the open-label phase had their most recent score carried forward. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.004
91674301|NCT02791893|183241910|SUPERIORITY|||||||0.005||||||This was a dependent t-test comparing baseline scores to the scores collected at the end of the open label phase.|t-test, 2 sided|||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the per protocol analysis. Patients that did not complete the assessment after the open-label phase were excluded. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.005
91674302|NCT04060719|183241916|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.48|||||TWO_SIDED|90.0|9.74|11.28|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.28|9.74|
91674303|NCT04060719|183241917|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|30.03|||||TWO_SIDED|90.0|25.76|35.02|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 25.2.|Relative bioavailability||35.02|25.76|
91674304|NCT04060719|183241918|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.39|||||TWO_SIDED|90.0|9.66|11.18|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.18|9.66|
91674305|NCT03208673|183241979|SUPERIORITY||Ratio of Geometric mean|0.5628||||0.001|TWO_SIDED|95.0|0.4395|0.7204|||t-test, 2 sided|||||0.7204|0.4395|.001
91674306|NCT03208673|183241980|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||Nasal||||0.025
91674307|NCT03208673|183241980|SUPERIORITY|||||||0.312|||||||t-test, 1 sided|||Temporal||||0.312
91674308|NCT03208673|183241981|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Comfort||||<0.001
91674309|NCT03208673|183241981|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Dry||||<0.001
91674310|NCT03208673|183241981|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Gritty||||<0.001
91674311|NCT03208673|183241981|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Vision||||<0.001
91674312|NCT03891329|183241983|OTHER|No comparison of two groups, just single arm design|SADE-free rate in the study group|0.98||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Cor Family devices until the 3- month follow-up are counted for this primary endpoint.~The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||1|0.9|0.05
91674313|NCT03891329|183241984|OTHER|Kaplan-Meier method|||||||||||||||||The Kaplan-Meier method will be applied to estimate the 3-month SADE-free rate at 92 days after implantation (sensitivity analysis of the primary endpoint) and the 12-month SADE-free rate at 365 days after implantation.|||
91674314|NCT03176784|183241987|SUPERIORITY||Odds Ratio (OR)|0.9||||0.66|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.66
91674315|NCT03176784|183241987|SUPERIORITY||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|.85
91674316|NCT03176784|183241987|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|1.00
91674317|NCT03176784|183241988|SUPERIORITY||Odds Ratio (OR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.7||Study site (Madison vs Milwaukee) was included as a covariate.|Regression, Logistic|||||1.7|0.8|.44
91674318|NCT03176784|183241988|SUPERIORITY||Odds Ratio (OR)|1.1||||0.61|TWO_SIDED|95.0|0.8|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.8|.61
91793216|NCT04449055|183464200|SUPERIORITY||Difference in median change|0.2676718||||0.2667|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank-sum test comparing changes in functional connectivity from baseline to 4 weeks between intervention groups.|Reported as difference in median change from baseline to 4 weeks for the MPFC first minus the median change from baseline to 4 weeks for the DPFC first group.|||||0.2667
91526513|NCT02906683|182928139|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.84||0.285|TWO_SIDED|95.0|-20.9|6.2|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.2|-20.9|0.285
91674319|NCT03176784|183241988|SUPERIORITY||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||2.0|0.9|.12
91674320|NCT03176784|183241989|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.43
91674321|NCT03176784|183241989|SUPERIORITY||Odds Ratio (OR)|0.8||||0.37|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.37
91674322|NCT03176784|183241989|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.7|.81
91674323|NCT03176784|183241990|SUPERIORITY||Odds Ratio (OR)|0.9||||0.65|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.65
91674324|NCT03176784|183241990|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.60
91674325|NCT03176784|183241990|SUPERIORITY||Odds Ratio (OR)|1.0||||0.86|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.5|0.7|.86
91674326|NCT02990806|183241991|EQUIVALENCE|A test for equivalence was carried out using an asymmetric margin (-12%, 15%) pre-specified in protocol and a two 1-sided test (TOST) analysis with α=0.05 for each 1-sided statistical test.|Percentage difference|3.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-4.3|11.5||||||||11.5|-4.3|
91674327|NCT00350402|183242059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.254|STANDARD_ERROR_OF_MEAN|2.028|<|0.001|TWO_SIDED|95.0|3.147|11.362|||t-test, 2 sided|df = 38; t = 3.576|Treatment effect size: Cohen's D =1.142|Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.||11.362|3.147|< 0.001
91674328|NCT00350402|183242060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.36|STANDARD_ERROR_OF_MEAN|4.955|<|0.459|TWO_SIDED|95.0|-16.41|3.68|||t-test, 2 sided|||Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).||3.68|-16.41|<0.459
91674329|NCT00350402|183242061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.426|STANDARD_ERROR_OF_MEAN|4.221|<|0.018|TWO_SIDED|95.0|1.874|18.978|||t-test, 2 sided|t-value = 2.47, with 37 df||Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.||18.978|1.874|<0.018
91674330|NCT00350402|183242062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129|STANDARD_ERROR_OF_MEAN|2.492|<|0.047|TWO_SIDED|95.0|0.0834|10.17||No adjustment necessary|t-test, 2 sided|38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = \<0.049, and adjusted df = 27.3||Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).||10.17|.0834|<0.047
91674331|NCT00645944|183242064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.039|TWO_SIDED|95.0|-7.5|-0.2|||Mixed Models Analysis|||||-0.2|-7.5|0.039
91674332|NCT00606502|183242072|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.61|1.14||||||||1.14|0.61|
91674333|NCT00560937|183242136|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||T-test of change scores, pregnenolone vs. placebo post-treatment compared to baseline.||||.048
91674334|NCT00560937|183242137|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
91674335|NCT00560937|183242138|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
91674336|NCT00560937|183242139|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||T-test of change scores, pregnenolone compared to placebo post-treatment vs. pre-randomization.||||1.0
91674337|NCT00560937|183242140|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
91674338|NCT00440115|183242142|SUPERIORITY|Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.12||||0.54|TWO_SIDED|95.0|0.78|1.61|||Mixed Models Analysis||(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management|||1.61|0.78|0.54
91674339|NCT00440115|183242142|SUPERIORITY|Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.33||||0.18|TWO_SIDED|95.0|0.88|2.02|||Mixed Models Analysis||High-intensity disease management vs moderate-intensity disease management|||2.02|0.88|0.18
91674340|NCT03069417|183242145|SUPERIORITY|Conducted at post-treatment time point.||||||0.11|||||||Mixed Models Analysis|||||||0.11
91674341|NCT03069417|183242145|SUPERIORITY|Conducted at 3-month follow-up time point.||||||0.56|||||||Mixed Models Analysis|||||||0.56
91674342|NCT03069417|183242146|SUPERIORITY|Main effect for time calculated at 3-month follow-up time point.|Fixed effects coefficient (β)|-12.7|||<|0.05|TWO_SIDED|95.0|-22.29|-3.15||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.15|-22.29|< 0.05
91674343|NCT03069417|183242147|SUPERIORITY|Interaction evaluated at post-treatment time point.|Fixed effects coefficient (β)|-11.1|||<|0.005|TWO_SIDED|95.0|-18.41|-3.83||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.83|-18.41|< 0.005
91716685|NCT00386334|183325200|SUPERIORITY_OR_OTHER|||||||0.0717||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0717
91716686|NCT00386334|183325203|SUPERIORITY_OR_OTHER|||||||0.1182||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|||||||0.1182
91793217|NCT04449055|183464201|SUPERIORITY||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|11.0972||0.6829|TWO_SIDED|||||Group by time interaction, with time as second measure date|Mixed Models Analysis||This is the adjusted difference in mean for mPFC first relative to DPFC first.|||||0.6829
91793218|NCT04449055|183464202|SUPERIORITY||Mean Difference (Final Values)|-0.3599|STANDARD_ERROR_OF_MEAN|1.1018||0.7654|TWO_SIDED|||||Group by time interaction p-value, with time as second (last) measure date|Mixed Models Analysis||This is the adjusted difference in mean for MPFC first relative to DPFC first.|||||0.7654
91793219|NCT04449055|183464203|SUPERIORITY||Slope|0.007388|STANDARD_ERROR_OF_MEAN|0.06256||0.907|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in slope for MPFC first versus DPFC first|||||0.9070
91526514|NCT02906683|182928141|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|6.48||0.082|TWO_SIDED|95.0|-24.1|1.5|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||1.5|-24.1|0.082
91526515|NCT02906683|182928141|SUPERIORITY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.34||0.057|TWO_SIDED|95.0|-24.7|0.4|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||0.4|-24.7|0.057
91674344|NCT03069417|183242147|SUPERIORITY|Main effect for time at 3-month follow-up time point.|Fixed effects coefficient (β)|-13.8|||<|0.005|TWO_SIDED|95.0|-22.5|-5.17||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-5.17|-22.50|< 0.005
91716687|NCT00386334|183325206|SUPERIORITY_OR_OTHER|||||||0.301||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.3010
91716688|NCT00386334|183325209|SUPERIORITY_OR_OTHER|||||||0.78||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.7800
91674345|NCT03069417|183242149|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|-10.1|||<|0.05|TWO_SIDED|95.0|-19.58|-0.67||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-0.67|-19.58|< 0.05
91674346|NCT03069417|183242149|SUPERIORITY|Main effect for time at post-treatment time point.|Fixed effects coefficient (β)|-12.8|||<|0.01|TWO_SIDED|95.0|-22.14|-3.37||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.37|-22.14|< 0.01
91674347|NCT03069417|183242150|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|6.2|||<|0.05|TWO_SIDED|95.0|0.5|11.88||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||11.88|0.50|< 0.05
91674348|NCT03360539|183242159|SUPERIORITY||Adjusted between-group difference|0.5|||||TWO_SIDED|95.0|-2.1|3.1|||||Adjusted between-group difference in the percentage of participants|||3.1|-2.1|
91674349|NCT03360539|183242160|SUPERIORITY||Adjusted between-group difference|0.4|||||TWO_SIDED|95.0|-2.3|3.0|||||Adjusted between-group difference in the percentage of participants|||3.0|-2.3|
91674350|NCT03360539|183242161|SUPERIORITY||Adjusted between-group difference|-1.1|||||TWO_SIDED|95.0|-2.9|0.8|||||Adjusted between-group difference in the percentage of participants|||0.8|-2.9|
91674351|NCT03360539|183242162|SUPERIORITY||Adjusted between-group difference|0.7|||||TWO_SIDED|95.0|-1.5|2.9|||||Adjusted between-group difference in the percentage of participants|||2.9|-1.5|
91674352|NCT03360539|183242163|SUPERIORITY||Adjusted between-group difference|-0.9|||||TWO_SIDED|95.0|-2.3|0.4|||||Adjusted between-group difference in the percentage of participants|||0.4|-2.3|
91674353|NCT03360539|183242164|SUPERIORITY||Adjusted between-group difference|-0.4|||||TWO_SIDED|95.0|-2.4|1.6|||||Adjusted between-group difference in the percentage of participants|||1.6|-2.4|
91674354|NCT03360539|183242165|SUPERIORITY||Adjusted between-group difference|-0.7|||||TWO_SIDED|95.0|-1.6|0.3|||||Adjusted between-group difference in the percentage of participants|||0.3|-1.6|
91674355|NCT03360539|183242166|SUPERIORITY||Adjusted between-group difference|-7.8|||||TWO_SIDED|95.0|-43.7|28.0|||||Adjusted between-group difference, in grams|||28.0|-43.7|
91674356|NCT03360539|183242167|SUPERIORITY||Adjusted between-group difference|-0.5|||||TWO_SIDED|95.0|-2.4|1.3|||||Adjusted between-group difference in the percentage of participants|||1.3|-2.4|
91674357|NCT03360539|183242168|SUPERIORITY||Adjusted between-group difference|0.0|||||TWO_SIDED|95.0|-0.6|0.5|||||Adjusted between-group difference in the percentage of participants|||0.5|-0.6|
91674358|NCT03360539|183242169|SUPERIORITY||Adjusted between-group difference|0.1|||||TWO_SIDED|95.0|0.0|0.2|||||Adjusted between-group difference, in weeks|||0.2|0.0|
91674359|NCT03360539|183242170|SUPERIORITY||Adjusted between-group difference|0.3|||||TWO_SIDED|95.0|-0.3|0.8|||||Adjusted between-group difference in the percentage of participants|||0.8|-0.3|
91674360|NCT03360539|183242171|SUPERIORITY||Adjusted between-group difference|-0.8|||||TWO_SIDED|95.0|-2.5|0.9|||||Adjusted between-group difference in the percentage of participants|||0.9|-2.5|
91793220|NCT04449055|183464204|SUPERIORITY||Odds Ratio, log|0.1095|STANDARD_ERROR_OF_MEAN|0.0747||0.1427|TWO_SIDED|95.0|-0.0369|0.2559||Based on group x continuous time interaction in generalized estimating equation logistic regression model clustered on subject. This is like a mixed model but uses empirical standard error estimates that are independent of covariance structure.|GEE logistic regression clustered on ID||Difference in change in log odds of positive UA for stimulant for MPFC first versus DPFC first. Estimated change in log odds per day in the study.|||0.2559|-0.0369|0.1427
91793221|NCT04449055|183464205|SUPERIORITY||Slope|0.02569|STANDARD_ERROR_OF_MEAN|0.02964||0.3917|TWO_SIDED||||||Mixed Models Analysis||This is the difference in slope for MPFC first relative to DPFC first.|||||0.3917
91641039|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.54|0.53|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.54|0.987
91793222|NCT04449055|183464206|SUPERIORITY||Slope|0.01759|STANDARD_ERROR_OF_MEAN|0.01948||0.3829|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Estimated difference in slope of change per day for MPFC first vs. DLPFC first|||||0.3829
91641040|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.04|TWO_SIDED|95.0|-1.33|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.33|0.040
91641041|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.319|TWO_SIDED|95.0|-0.31|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.31|0.319
91641042|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.712|TWO_SIDED|95.0|-0.47|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.47|0.712
91641043|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.557|TWO_SIDED|95.0|-0.91|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.49|-0.91|0.557
91641044|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.015|TWO_SIDED|95.0|0.14|1.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.28|0.14|0.015
91641045|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.326|TWO_SIDED|95.0|-0.26|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.26|0.326
91641046|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.167|TWO_SIDED|95.0|-1.08|0.19|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.19|-1.08|0.167
91674361|NCT03360539|183242172|SUPERIORITY||Adjusted between-group difference|0.7|||||TWO_SIDED|95.0|-1.1|2.4|||||Adjusted between-group difference in the percentage of participants|||2.4|-1.1|
91674362|NCT03360539|183242173|SUPERIORITY||Adjusted between-group difference|-2.0|||||TWO_SIDED|95.0|-4.7|0.7|||||Adjusted between-group difference in the percentage of participants|||0.7|-4.7|
91674363|NCT03360539|183242174|SUPERIORITY||Adjusted between-group difference|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Adjusted between-group difference in the percentage of participants|||0.9|-0.5|
91674364|NCT03360539|183242178|SUPERIORITY||Adjusted between-group difference|-0.3|||||TWO_SIDED|95.0|-3.2|2.5|||||Adjusted between-group difference in the percentage of participants|||2.5|-3.2|
91674365|NCT03360539|183242179|SUPERIORITY||Adjusted between-group difference|-0.66|||||TWO_SIDED|95.0|-3.0|1.7|||||Adjusted between-group difference in the percentage of participants|||1.7|-3.0|
91674366|NCT03360539|183242180|SUPERIORITY||Adjusted between-group difference|1.01|||||TWO_SIDED|95.0|0.95|1.08|||||Adjusted between-group difference, in number of visits|||1.08|0.95|
91674367|NCT03360539|183242181|SUPERIORITY||Adjusted between-group difference|2.47|||||TWO_SIDED|95.0|0.1|4.9|||||Adjusted between-group difference in the percentage of participants|||4.9|0.1|
91674368|NCT03360539|183242182|SUPERIORITY||Adjusted between-group difference|0.44|||||TWO_SIDED|95.0|-2.1|3.0|||||Adjusted between-group difference in the percentage of participants|||3.0|-2.1|
91674369|NCT03360539|183242184|SUPERIORITY||Adjusted between-group difference|-0.12|||||TWO_SIDED|95.0|-3.1|2.9|||||Adjusted between-group difference in the percentage of participants|||2.9|-3.1|
91674370|NCT03360539|183242185|SUPERIORITY||Adjusted between-group difference|0.65|||||TWO_SIDED|95.0|-2.4|3.7|||||Adjusted between-group difference in the percentage of participants|||3.7|-2.4|
91674371|NCT03360539|183242186|SUPERIORITY||Adjusted between-group difference|-4.18|||||TWO_SIDED|95.0|-8.0|-0.4|||||Adjusted between-group difference in the percentage of participants|||-0.4|-8.0|
91674372|NCT03360539|183242194|SUPERIORITY||Adjusted between-group difference|0.2|||||TWO_SIDED|95.0|-2.4|2.8|||||Adjusted between-group difference in the percentage of participants|||2.8|-2.4|
91674373|NCT03360539|183242195|SUPERIORITY||Adjusted between-group difference|0.1|||||TWO_SIDED|95.0|-1.1|1.3|||||Adjusted between-group difference in the percentage of participants|||1.3|-1.1|
91674374|NCT03360539|183242196|SUPERIORITY||Adjusted between-group difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Adjusted between-group difference, in number of injuries|||0.1|-0.1|
91674375|NCT03360539|183242197|SUPERIORITY||Adjusted between-group difference|-2.7|||||TWO_SIDED|95.0|-5.3|-0.1|||||Adjusted between-group difference in the percentage of participants|||-0.1|-5.3|
91526516|NCT02906683|182928143|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|7.38||0.019|TWO_SIDED|95.0|-32.2|-3.0|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-3.0|-32.2|0.019
91641047|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.35|TWO_SIDED|95.0|-0.33|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.33|0.350
91641048|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.235|TWO_SIDED|95.0|-0.23|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.23|0.235
91641049|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.881|TWO_SIDED|95.0|-0.65|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.76|-0.65|0.881
91641050|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.036|TWO_SIDED|95.0|0.04|1.16|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.16|0.04|0.036
91641051|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.656|TWO_SIDED|95.0|-0.4|0.63|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.63|-0.40|0.656
91641052|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.13|TWO_SIDED|95.0|-1.11|0.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.14|-1.11|0.130
91641053|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.3|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.30|0.304
91641054|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.491|TWO_SIDED|95.0|-0.37|0.78|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.78|-0.37|0.491
91641055|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.82|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.82|0.726
91716689|NCT00386334|183325212|SUPERIORITY_OR_OTHER|||||||0.0803||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0803
91716690|NCT00386334|183325215|SUPERIORITY_OR_OTHER|||||||0.2643||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2643
91716691|NCT00386334|183325218|SUPERIORITY_OR_OTHER|||||||0.0765||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0765
91716692|NCT00386334|183325221|SUPERIORITY_OR_OTHER|||||||0.2967||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2967
91716693|NCT00386334|183325224|SUPERIORITY_OR_OTHER|||||||0.0634||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0634
91526517|NCT02906683|182928143|SUPERIORITY||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|7.36||0.023|TWO_SIDED|95.0|-31.5|-2.3|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-2.3|-31.5|0.023
91641056|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.029|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.029
91641057|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.585|TWO_SIDED|95.0|-0.39|0.68|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.39|0.585
91641058|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.131|TWO_SIDED|95.0|-1.15|0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.15|-1.15|0.131
91641059|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.24|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.04|-0.24|0.215
91793223|NCT04449055|183464207|SUPERIORITY||Slope|0.01691|STANDARD_ERROR_OF_MEAN|0.054||0.7595|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Estimated difference in slope of change per day for MPFC first vs. DLPFC first|||||0.7595
91793224|NCT04449055|183464208|SUPERIORITY||Slope|0.04356|STANDARD_ERROR_OF_MEAN|0.04804||0.3839|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in slope of change per day for MPFC first vs. DLPFC first|||||0.3839
91793225|NCT04449055|183464209|SUPERIORITY||Slope|0.005445|STANDARD_ERROR_OF_MEAN|0.01642||0.7455|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Estimated difference in slope of change per day for MPFC first vs. DLPFC first|||||0.7455
91793226|NCT04449055|183464210|SUPERIORITY||Slope|0.2125|STANDARD_ERROR_OF_MEAN|0.1159||0.0823|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.0823
91793227|NCT04449055|183464211|SUPERIORITY||Slope|-0.04735|STANDARD_ERROR_OF_MEAN|0.07382||0.5289|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.5289
91793228|NCT04449055|183464212|SUPERIORITY||Slope|-0.00231|STANDARD_ERROR_OF_MEAN|0.06359||0.9714|TWO_SIDED|||||Group by time interaction|Mixed Models Analysis||Estimated difference in change per day for MPFC first versus DPFC first|||||0.9714
91793229|NCT04449055|183464213|SUPERIORITY||Slope|0.1268|STANDARD_ERROR_OF_MEAN|0.1153||0.2914|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DLPFC first|||||0.2914
91793230|NCT04449055|183464214|SUPERIORITY||Slope|0.1609|STANDARD_ERROR_OF_MEAN|0.08||0.0573|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.0573
91793231|NCT04449055|183464215|SUPERIORITY||Slope|0.008267|STANDARD_ERROR_OF_MEAN|0.08675||0.925|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.9250
91793232|NCT04449055|183464216|SUPERIORITY||Slope|0.000766|STANDARD_ERROR_OF_MEAN|0.02679||0.9775|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.9775
91641060|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.244|TWO_SIDED|95.0|-0.24|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.24|0.244
91641061|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.885|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.66|-0.76|0.885
91641062|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.04|0.067
91641063|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5|TWO_SIDED|95.0|-0.35|0.73|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.35|0.500
91793233|NCT04449055|183464217|SUPERIORITY||Slope|0.002498|STANDARD_ERROR_OF_MEAN|0.02518||0.9211|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.9211
91793234|NCT04449055|183464218|SUPERIORITY||Slope|-0.2995|STANDARD_ERROR_OF_MEAN|0.4196||0.5269|TWO_SIDED|||||Group by continuous time interaction|Mixed Models Analysis||Difference in estimated change per day for MPFC first versus DPFC first|||||0.5269
91793235|NCT06596005|183464244|OTHER||Difference in least squares means|-6.37|STANDARD_ERROR_OF_MEAN|0.871|<|0.0001|TWO_SIDED|95.0|-8.09|-4.64||The LSM, SE, and difference from placebo with 95% CI and nominal P-value are estimated using MMRM, with baseline MDS-UPDRS Part III scores and L-Dopa use as covariates, and treatment group, visit, and group-by-visit interaction as fixed effects.|MMRM|||||-4.64|-8.09|<0.0001
91793236|NCT06596005|183464244|OTHER||Difference in least squares means|-6.7|STANDARD_ERROR_OF_MEAN|0.886|<|0.0001|TWO_SIDED|95.0|-8.45|-4.95||The LSM, SE, and difference from placebo with 95% CI and nominal P-value are estimated using MMRM, with baseline MDS-UPDRS Part III scores and L-Dopa use as covariates, and treatment group, visit, and group-by-visit interaction as fixed effects.|MMRM|||||-4.95|-8.45|<0.0001
91793237|NCT02445391|183464245|NON_INFERIORITY|The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.81|||||The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.|||1.81|0.62|
91485777|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.647
91641064|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.276|TWO_SIDED|95.0|-1.02|0.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.29|-1.02|0.276
91674376|NCT03360539|183242198|SUPERIORITY||Adjusted between-group difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1|||||Adjusted between-group difference, in number of visits|||0.1|-0.7|
91674377|NCT03360539|183242199|SUPERIORITY||Adjusted between-group difference|0.3|||||TWO_SIDED|95.0|-0.4|1.0|||||Adjusted between-group difference in the percentage of participants|||1.0|-0.4|
91674378|NCT03360539|183242200|SUPERIORITY||Adjusted between-group difference|2.3|||||TWO_SIDED|95.0|-0.4|5.0|||||Adjusted between-group difference in the percentage of participants|||5.0|-0.4|
91793238|NCT04814654|183464259|SUPERIORITY|||||||0.989|||||||Chi-squared|||||||0.989
91793239|NCT04814654|183464259|SUPERIORITY||Odds Ratio (OR)|1.02||||0.949|TWO_SIDED|95.0|0.6|1.74|||Regression, Logistic|||||1.74|0.60|0.949
91793240|NCT04814654|183464259|SUPERIORITY||Odds Ratio (OR)|1.04||||0.882|TWO_SIDED|95.0|0.61|1.78|||Regression, Logistic|||||1.78|0.61|0.882
91793241|NCT04814654|183464260|SUPERIORITY|||||||0.0726|||||||Chi-squared|||||||.0726
91793242|NCT04814654|183464261|SUPERIORITY|||||||0.918|||||||Kruskal-Wallis|||12 month timepoint||||0.918
91485778|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.507
91485779|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.821
91485780|NCT00785928|182844673|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.045
91526518|NCT02906683|182928145|SUPERIORITY||Mean Difference (Final Values)|-11.4|STANDARD_ERROR_OF_MEAN|7.36||0.125|TWO_SIDED|95.0|-25.9|3.2|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||3.2|-25.9|0.125
91526519|NCT02906683|182928145|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|7.8||0.221|TWO_SIDED|95.0|-25.1|5.9|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||5.9|-25.1|0.221
91641065|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.413|TWO_SIDED|95.0|-0.38|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.38|0.413
91641066|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.448|TWO_SIDED|95.0|-0.37|0.83|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.83|-0.37|0.448
91641067|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.917|TWO_SIDED|95.0|-0.76|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.76|0.917
91641068|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.132|TWO_SIDED|95.0|-0.13|1.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.03|-0.13|0.132
91793243|NCT04814654|183464261|SUPERIORITY|||||||0.948|||||||Kruskal-Wallis|||||||0.948
91793244|NCT04814654|183464261|SUPERIORITY|||||||0.0766|||||||Kruskal-Wallis|||||||.0766
91793245|NCT04814654|183464262|SUPERIORITY|||||||0.1839|||||||Chi-squared|||12 months||||0.1839
91793246|NCT04814654|183464262|SUPERIORITY|||||||0.127|||||||Chi-squared|||18 months||||.127
91485781|NCT00785928|182844676|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||Pairwise (2-sided) comparisons of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.236
91485782|NCT00785928|182844676|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Pairwise (2-sided) comparisons of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.038
91526520|NCT01158378|182928153|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%||||||0.0049|||||||one-sided z-test|||||||0.0049
91641069|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.505|TWO_SIDED|95.0|-0.35|0.72|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.72|-0.35|0.505
91674379|NCT03360539|183242201|SUPERIORITY||Adjusted between-group difference|0.5|||||TWO_SIDED|95.0|-2.3|3.2|||||Adjusted between-group difference in the percentage of participants|||3.2|-2.3|
91674380|NCT03360539|183242202|SUPERIORITY||Adjusted between-group difference|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Adjusted between-group difference in the percentage of participants|||2.0|-3.4|
91674381|NCT03360539|183242203|SUPERIORITY||Adjusted between-group difference|1.7|||||TWO_SIDED|95.0|-1.0|4.5|||||Adjusted between-group difference in the percentage of participants|||4.5|-1.0|
91674382|NCT03360539|183242204|SUPERIORITY||Adjusted between-group difference|0.2|||||TWO_SIDED|95.0|-2.6|3.1|||||Adjusted between-group difference in the percentage of participants|||3.1|-2.6|
91674383|NCT03360539|183242205|SUPERIORITY||Adjusted between-group difference|-0.3|||||TWO_SIDED|95.0|-2.4|1.7|||||Adjusted between-group difference in the percentage of participants|||1.7|-2.4|
91674384|NCT03360539|183242206|SUPERIORITY||Adjusted between-group difference|-0.7|||||TWO_SIDED|95.0|-1.9|0.6|||||Adjusted between-group difference in the percentage of participants|||0.6|-1.9|
91674385|NCT03360539|183242208|SUPERIORITY||Adjusted between-group difference|-1.5|||||TWO_SIDED|95.0|-4.3|1.3|||||Adjusted between-group difference in the percentage of participants|||1.3|-4.3|
91674386|NCT03360539|183242209|SUPERIORITY||Adjusted between-group difference|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Adjusted between-group difference in the percentage of participants|||2.0|-3.4|
91674387|NCT03360539|183242210|SUPERIORITY||Adjusted between-group difference|0.8|||||TWO_SIDED|95.0|-1.0|2.7|||||Adjusted between-group difference in the percentage of participants|||2.7|-1.0|
91674388|NCT03360539|183242211|SUPERIORITY||Adjusted between-group difference|-0.4|||||TWO_SIDED|95.0|-3.0|2.2|||||Adjusted between-group difference in the percentage of participants|||2.2|-3.0|
91716694|NCT00386334|183325227|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
91716695|NCT03238417|183325236|NON_INFERIORITY|Analysis of Variance comparing change in outcome between EBQI and control from baseline to 12 month.|Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|1.32||0.623|TWO_SIDED|95.0|-3.3|2.0||P-value is from the interaction term between EBQI and time.|ANOVA|||||2.0|-3.3|0.623
91716696|NCT03238417|183325237|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control from baseline to 24 months.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|1.1||0.678|TWO_SIDED|95.0|-2.8|1.8||P-value is from the interaction term of EBQI and time.|ANOVA|||||1.8|-2.8|0.678
91716697|NCT03238417|183325238|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.364|TWO_SIDED|95.0|-0.17|0.35||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 12-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 12-month||0.35|-0.17|0.364
91716698|NCT03238417|183325239|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.29|TWO_SIDED|95.0|-0.33|0.1||P-value reflects the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 24-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 24-month||0.10|-0.33|0.29
91716699|NCT03238417|183325240|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.69|STANDARD_ERROR_OF_MEAN|0.42||0.1|TWO_SIDED|95.0|-1.52|0.13||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Difference-in-Differences analysis||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.13|-1.52|0.10
91716700|NCT03238417|183325241|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.22|TWO_SIDED|95.0|-1.25|0.29||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Logistic||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.29|-1.25|0.22
91716701|NCT03238417|183325242|NON_INFERIORITY|Analysis of Variance testing the differences in outcome between EBQI and control groups over 12 month period.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|3.1||0.788|TWO_SIDED|95.0|-7.1|5.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||5.4|-7.1|0.788
91716702|NCT03238417|183325243|NON_INFERIORITY|Analysis of Variance testing for differences in outcomes between EBQI and control arms from baseline to 24 months.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|2.89||0.61|TWO_SIDED|95.0|-7.35|4.35||The p-value reflects the interaction terms between EBQI and control arms.|ANOVA|||||4.35|-7.35|0.61
91716703|NCT03238417|183325244|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|10.5||0.987|TWO_SIDED|95.0|-21.45|21.11||The p-value reflects the interaction term between EBQI and time|ANOVA|||||21.11|-21.45|0.987
91716704|NCT03238417|183325245|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-3.91|STANDARD_ERROR_OF_MEAN|10.35||0.708|TWO_SIDED|95.0|-24.89|17.08||The p-value reflects the interaction terms between EBQI and time|ANOVA|||||17.08|-24.89|0.708
91716705|NCT03238417|183325246|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-4.51|STANDARD_ERROR_OF_MEAN|8.85||0.613|TWO_SIDED|95.0|-22.43|13.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||13.40|-22.43|0.613
91716706|NCT03238417|183325247|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|9.48||0.922|TWO_SIDED|95.0|-18.26|20.13||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||20.13|-18.26|0.922
91716707|NCT03238417|183325248|NON_INFERIORITY|two-way ANOVA testing change in a composite score of gender-neutral preventive care between EBQI and control arms over time|Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.13||0.789|TWO_SIDED|95.0|-3.74|4.89||The p-value represents the interaction term between EBQI and control.|ANOVA|||||4.89|-3.74|0.789
91716708|NCT03238417|183325249|NON_INFERIORITY|ANOVA comparing changes in outcomes over time between EBQI and control groups|Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|2.45||0.51|TWO_SIDED|95.0|-6.6|3.33||The p-value reflects the interaction between EBQI and time.|ANOVA|The analysis is adjusted for EBQI and time.||||3.33|-6.60|0.51
91793247|NCT04814654|183464263|SUPERIORITY|||||||0.7313|||||||Chi-squared|||||||0.7313
91793248|NCT04814654|183464264|SUPERIORITY|||||||0.1839|||||||Chi-squared|||||||0.1839
91526521|NCT01158378|182928154|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
91716709|NCT03238417|183325250|NON_INFERIORITY|ANOVA testing for change in outcome over time between EBQI and control arms|Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|8.3||0.711|TWO_SIDED|95.0|-13.7|19.9||The p-value reflects the interaction between EBQI and time|ANOVA|||||19.9|-13.7|0.711
91716710|NCT03238417|183325251|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|8.49|STANDARD_ERROR_OF_MEAN|8.7||0.335|TWO_SIDED|95.0|-9.1|26.1||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||26.1|-9.1|0.335
91716711|NCT03238417|183325252|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control groups from baseline to 12 months.|Mean Difference (Net)|-13.8|STANDARD_ERROR_OF_MEAN|12.3||0.268|TWO_SIDED|95.0|-38.7|11.1||P-value is from the interaction term between EBQI and time.|ANOVA|||||11.1|-38.7|0.268
91716712|NCT03238417|183325253|NON_INFERIORITY|Analysis of Variance testing the differences between EBQI and control from baseline and 24 months|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|12.6||0.991|TWO_SIDED|95.0|-25.6|25.3||P-value is from the interaction between EBQI and time.|ANOVA|||||25.3|-25.6|0.991
91716713|NCT02089347|183325254|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|1.42|||||TWO_SIDED|95.0|-0.31|4.61||||||Non-inferiority comparison of post-booster response for Diphtheria.||4.61|-0.31|
91716714|NCT02089347|183325254|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by the data if lower bound ot the two-sided 95% is greater than -10%|Wilson score method|6.25|||||TWO_SIDED|95.0|3.32|10.84||||||Non-inferiority comparison of post-vaccination booster response for tetanus||10.84|3.32|
91716715|NCT02089347|183325255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|0.57|||||TWO_SIDED|95.0|-0.61|3.15||||||Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL||3.15|-0.61|
91716716|NCT02089347|183325255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%.|Wilson score method|0.0|||||TWO_SIDED|95.0|-1.09|2.14||||||Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL||2.14|-1.09|
91716717|NCT01249131|183325271|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|94.7|||||TWO_SIDED|90.0|83.9|107.0|||||LS mean was calculated from analysis of variance (ANOVA). Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||107|83.9|
91793249|NCT04814654|183464265|SUPERIORITY|||||||0.2667|||||||Fisher Exact|||||||0.2667
91716718|NCT01249131|183325271|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|110.0|||||TWO_SIDED|90.0|98.2|124.0|||||LS mean was calculated from ANOVA. Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124|98.2|
91716719|NCT01249131|183325272|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.9|||||TWO_SIDED|90.0|84.2|111.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||111|84.2|
91716720|NCT01249131|183325272|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|107.0|||||TWO_SIDED|90.0|93.8|123.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||123|93.8|
91716721|NCT00473083|183325289|SUPERIORITY_OR_OTHER|||||||0.8769||||||P for arm 1 v arms 2 and 3 combined|Chi-squared|||||||0.8769
91716722|NCT00473083|183325289|SUPERIORITY_OR_OTHER|||||||0.147||||||P for arm 1 v arms 2 and 3 combined|Wilcoxon (Mann-Whitney)|||||||0.147
91716723|NCT00473083|183325290|SUPERIORITY_OR_OTHER|||||||0.1503||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.1503
91716724|NCT00473083|183325290|SUPERIORITY_OR_OTHER|||||||0.4681||||||P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.4681
91716725|NCT00473083|183325290|SUPERIORITY_OR_OTHER|||||||0.0196||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.0196
91716726|NCT00473083|183325290|SUPERIORITY_OR_OTHER|||||||0.1658||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.1658
91716727|NCT00473083|183325290|SUPERIORITY_OR_OTHER||||||>|0.9999||||||"P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.~P-value was calculated to be \>0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms."|Wilcoxon (Mann-Whitney)|||||||>0.9999
91526522|NCT01158378|182928154|SUPERIORITY_OR_OTHER|||||||0.0297|||||||one-sided z-test|||Superiority Test||||0.0297
91716728|NCT00473083|183325290|SUPERIORITY_OR_OTHER|||||||0.285||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.285
91716729|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.5097|||||||Chi-squared|||Maximal Rash Grade 1||||0.5097
91716730|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.474|||||||Chi-squared|||Maximal Rash Grade 2a||||0.4740
91716731|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.2123|||||||Chi-squared|||Maximal Severity Grade 2b||||0.2123
91716732|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.5004|||||||Chi-squared|||Maximal Severity Grade 3||||0.5004
91716733|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.9072|||||||Chi-squared|||Maximal Severity Grade 1||||0.9072
91526523|NCT01158378|182928155|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
91716734|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.0464|||||||Chi-squared|||Maximal Severity Grade 2a||||0.0464
91716735|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.6759|||||||Chi-squared|||Maximal Severity Grade 2b||||0.6759
91793250|NCT04814654|183464266|SUPERIORITY|||||||0.999|||||||Fisher Exact|||||||0.999
91793251|NCT04814654|183464267|SUPERIORITY|||||||0.1414|||||||Chi-squared|||||||0.1414
91793252|NCT04814654|183464268|SUPERIORITY|||||||0.425|||||||Chi-squared|||||||0.425
91793253|NCT04814654|183464280|SUPERIORITY|||||||0.9183|||||||Kruskal-Wallis|||||||0.9183
91793254|NCT06837116|183464302|OTHER||||||<|0.01|||||||Kruskal-Wallis|followed by Dunn's multiple comparisons test||Kruskal-Wallis test followed by Dunn's multiple comparisons test||||< 0.01
91641070|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.92|0.38|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.38|-0.92|0.422
91485783|NCT00785928|182844676|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Pairwise (2-sided) comparisons of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
91641071|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.747|TWO_SIDED|95.0|-0.54|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.54|0.747
91641072|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.386|TWO_SIDED|95.0|-0.34|0.87|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.34|0.386
91641073|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.668|TWO_SIDED|95.0|-0.57|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.89|-0.57|0.668
91641074|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.099|TWO_SIDED|95.0|-0.09|1.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.08|-0.09|0.099
91641075|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.365|TWO_SIDED|95.0|-0.29|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.29|0.365
91641076|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.463|TWO_SIDED|95.0|-0.9|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.41|-0.90|0.463
91641077|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.845|TWO_SIDED|95.0|-0.6|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.60|0.845
91641078|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.21|0.199
91485784|NCT00785928|182844676|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Pairwise (2-sided) comparisons of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.005
91485785|NCT00785928|182844676|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||Pairwise (2-sided) comparisons of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.734
91485786|NCT00785928|182844676|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Pairwise (2-sided) comparisons of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.035
91674389|NCT03360539|183242212|SUPERIORITY||Adjusted between-group difference|0.1|||||TWO_SIDED|95.0|-2.6|2.9|||||Adjusted between-group difference in the percentage of participants|||2.9|-2.6|
91674390|NCT03360539|183242213|SUPERIORITY||Adjusted between-group difference|0.5|||||TWO_SIDED|95.0|-1.5|2.6|||||Adjusted between-group difference in the percentage of participants|||2.6|-1.5|
91674391|NCT03360539|183242214|SUPERIORITY||Adjusted between-group difference|0.13|||||TWO_SIDED|95.0|-0.1|0.37|||||Adjusted between-group difference, in months|||0.37|-0.1|
91674392|NCT03360539|183242215|SUPERIORITY||Adjusted between-group difference|0.03|||||TWO_SIDED|95.0|-0.45|0.5|||||Adjusted between-group difference, in months|||0.5|-0.45|
91674393|NCT03360539|183242216|SUPERIORITY||Adjusted between-group difference|2.1|||||TWO_SIDED|95.0|0.3|4.0|||||Adjusted between-group difference in the percentage of participants|||4.0|0.3|
91674394|NCT03360539|183242217|SUPERIORITY||Adjusted between-group difference|0.6|||||TWO_SIDED|95.0|0.1|1.1|||||Adjusted between-group difference, in months|||1.1|0.1|
91674395|NCT03360539|183242218|SUPERIORITY||Adjusted between-group difference|1.1|||||TWO_SIDED|95.0|-0.7|3.0|||||Adjusted between-group difference in the percentage of participants|||3.0|-0.7|
91674396|NCT03545191|183242219|OTHER||LS mean difference to placebo|-12.2|||<|0.0001|TWO_SIDED|95.0|-17.435|-6.961||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-6.961|-17.435|<0.0001
91674397|NCT03545191|183242219|OTHER||LS mean difference to placebo|-22.78|||<|0.0001|TWO_SIDED|95.0|-27.996|-17.567||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 50 mg vs placebo).||-17.567|-27.996|<0.0001
91674398|NCT03545191|183242220|OTHER||LS mean difference to placebo|-11.86|||<|0.0001|TWO_SIDED|95.0|-17.494|-6.23||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-6.23|-17.494|<0.0001
91674399|NCT03545191|183242220|OTHER||LS mean difference to placebo|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.945|-12.661||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 50 mg vs placebo).||-12.661|-23.945|<0.0001
91674400|NCT03545191|183242221|OTHER||LS mean difference to placebo|-8.32||||0.0005|TWO_SIDED|95.0|-13.014|-3.629||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-3.629|-13.014|0.0005
91674401|NCT03545191|183242221|OTHER||LS mean difference to placebo|-11.35|||<|0.0001|TWO_SIDED|95.0|-16.022|-6.687||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||-6.687|-16.022|<0.0001
91674402|NCT03545191|183242222|OTHER||LS mean difference to placebo|-7.59||||0.0015|TWO_SIDED|95.0|-12.265|-2.923||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.923|-12.265|0.0015
91674403|NCT03545191|183242222|OTHER||LS mean difference to placebo|-11.67|||<|0.0001|TWO_SIDED|95.0|-16.348|-6.994||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||-6.994|-16.348|<0.0001
91674404|NCT03545191|183242223|OTHER||LS mean difference to placebo|12.62|||=|0.0013|TWO_SIDED|95.0|4.953|20.288||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||20.288|4.953|= 0.0013
91716736|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Chi-squared|||Maximal Severity Grade 3||||0.0065
91793255|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence|Slope|0.0||||0.74|TWO_SIDED|95.0|-0.1|0.2||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Age covariate effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.2|-0.1|0.74
91526524|NCT01158378|182928155|SUPERIORITY_OR_OTHER|||||||0.0561|||||||one-sided z-test|||Superiority Test||||0.0561
91674405|NCT03545191|183242223|OTHER||LS mean difference to placebo|22.06|||<|0.0001|TWO_SIDED|95.0|14.405|29.708||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||29.708|14.405|< 0.0001
91674406|NCT03545191|183242224|OTHER||LS mean difference to placebo|9.93|||=|0.0334|TWO_SIDED|95.0|0.782|19.082||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||19.082|0.782|= 0.0334
91674407|NCT03545191|183242224|OTHER||LS mean difference to placebo|19.77|||<|1e-05|TWO_SIDED|95.0|10.623|28.918||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 50 mg vs placebo).||28.918|10.623|< .00001
91674408|NCT03545191|183242225|OTHER||LS mean difference to placebo|-0.75|||=|0.0547|TWO_SIDED|95.0|-1.515|0.015||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.015|-1.515|= 0.0547
91674409|NCT03545191|183242225|OTHER||LS mean difference to placebo|-1.75|||<|1e-05|TWO_SIDED|95.0|-2.508|-0.983||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 50 mg vs placebo).||-0.983|-2.508|< .00001
91674410|NCT03545191|183242226|OTHER||LS mean difference to placebo|-0.99||||0.0534|TWO_SIDED|95.0|-1.99|0.014||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||0.014|-1.990|0.0534
91674411|NCT03545191|183242226|OTHER||LS mean difference to placebo|-1.9|||=|0.0002|TWO_SIDED|95.0|-2.905|-0.905|||Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 50 mg vs placebo).||-0.905|-2.905|= 0.0002
91716737|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.5898|||||||Chi-squared|||Maximal Severity Grade 1||||0.5898
91526525|NCT03980184|182928198|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
91674412|NCT03545191|183242227|OTHER||LSGM ratio to placebo|0.79||||0.0003|TWO_SIDED|95.0|0.7|0.9||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.90|0.70|0.0003
91674413|NCT03545191|183242227|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||0.82|0.65|<0.0001
91674414|NCT03545191|183242228|OTHER||LSGM ratio to placebo|0.78||||0.0002|TWO_SIDED|95.0|0.68|0.89||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.89|0.68|0.0002
91674415|NCT03545191|183242228|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.83||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||0.83|0.64|<0.0001
91674416|NCT01277718|183242232|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|111.0|||||TWO_SIDED|90.0|98.02|124.99|||||LS mean was calculated from Analysis of variance (ANOVA). Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124.99|98.02|
91674417|NCT01277718|183242232|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.2|||||TWO_SIDED|90.0|85.06|108.77|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||108.77|85.06|
91526526|NCT03980184|182928199|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<.001
91674418|NCT01277718|183242232|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|106.0|||||TWO_SIDED|90.0|94.53|119.91|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||119.91|94.53|
91674419|NCT01277718|183242233|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|100.0|||||TWO_SIDED|90.0|85.09|118.03|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||118.03|85.09|
91716738|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.1921|||||||Chi-squared|||Maximal Severity Grade 2a||||0.1921
91716739|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.0882|||||||Chi-squared|||Maximal Severity Grade 2b||||0.0882
91526527|NCT03980184|182928200|SUPERIORITY|||||||0.703|||||||Fisher Exact|||||||0.703
91526528|NCT03980184|182928202|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91526529|NCT03980184|182928203|SUPERIORITY|||||||0.647|||||||Fisher Exact|||||||0.647
91526530|NCT03980184|182928204|SUPERIORITY|||||||0.887|||||||Fisher Exact|||||||0.887
91674420|NCT01277718|183242233|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.7|||||TWO_SIDED|90.0|72.51|101.33|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.33|72.51|
91674421|NCT01277718|183242233|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.9|||||TWO_SIDED|90.0|72.94|101.17|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.17|72.94|
91674422|NCT03919162|183242238|SUPERIORITY||Difference LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.048||0.2261|TWO_SIDED|95.0|-0.036|0.152||"Null hypothesis was that there was no difference in change of ABC score between the PQ912 and Placebo group after 24 weeks of treatment.~P-values \<0.05 were considered to be statistically significant."|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline ABC score, time, treatment group, and time by treatment group interaction.|Treatment difference = PQ912 - Placebo|Initially after Phase 2A, a futility analysis was planned with a sample size of 90 participants per treatment group to test the 1-sided hypothesis that the rate of decrease of ABC score is greater for the PQ912 group than for the Placebo group. The test should be carried out at a 1-sided 40% significance level, using the mixed effects model. Due to early termination of the study and limited sample size, analysis of Phase 2A data was done in the same manner as final analysis of Phase 2B data.||0.152|-0.036|0.2261
91674423|NCT03919162|183242239|SUPERIORITY||Difference LS Mean|-0.00526|STANDARD_ERROR_OF_MEAN|0.00742||0.4814|TWO_SIDED|95.0|-0.02017|0.00964||"Null hypothesis was that there was no difference in change of EEG theta power between the PQ912 and Placebo groups after 24 weeks of treatment.~Tests were declared statistically significant if the calculated p-value was ≤ 0.05."|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline qEEG data, time, treatment group, and time by treatment group interaction.|Treatment difference = PQ912 - Placebo|"Initially after Phase 2A, a futility analysis was planned with a sample size of 90 participants per treatment group to test the hypothesis that increase in EEG theta power is greater for Placebo than for PQ912 (1-sided, alpha = 0.05). Higher theta power is worse; hence this alternative hypothesis indicates benefit of the drug.~Due to early termination of the study and limited sample size, analysis of Phase 2A data was done in the same manner as final analysis of Phase 2B data."||0.00964|-0.02017|0.4814
91692155|NCT03296527|183279338|NON_INFERIORITY|If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.|Risk Difference (RD)|5.4|||||TWO_SIDED|95.0|-0.2|11.0|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing pregnancy rate||11.0|-0.2|
91692156|NCT03296527|183279339|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.3|12.3|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with positive beta-hCG||12.3|0.3|
91674424|NCT03919162|183242240|SUPERIORITY||Difference LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.49||0.9135|TWO_SIDED|95.0|-1.03|0.92||Tests were declared statistically significant if the calculated p-value is ≤ 0.05.|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline CDR-SB score, time, treatment group, and time by treatment group interaction.|Treatment difference = PQ912 - Placebo|Null hypothesis is that there was no difference in the change of CDR-SB scores between the PQ912 and the Placebo arms. The primary analysis used a mixed model for repeated measures (MMRM) with within-participant change in CDR-SB score as the outcome. The study planned with 207 participants (including 25% drop-out) per group to have 80% power to detect an effect size of 0.7 points in CDR-SB score. Power calculation was based on a 2-sided t-test with significance level of 0.05.||0.92|-1.03|0.9135
91674425|NCT03919162|183242241|SUPERIORITY||Difference LS Mean|0.969|STANDARD_ERROR_OF_MEAN|2.14||0.6528|TWO_SIDED|95.0|-3.345|5.238||The secondary analysis used a mixed model for repeated measures (MMRM) with the within-participant change compared between active arm and placebo in CFC2 as the outcome.|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline CFC2, time, treatment group, time by treatment group interaction.|Treatment difference = PQ912 - Placebo|A hierarchical approach is taken: The key secondary CFC2 follows the primary endpoint (Clinical Dementia Rating - Sum of Boxes), if it is statistically significant, followed by the remaining secondary endpoints in the order defined per Statistical Analysis Plan. Hierarchical testing is stopped as soon as a non-significant result is encountered. If the primary hypothesis is met, then a test for a statistically significant difference will be conducted for the CFC2, however at 4% significance level||5.238|-3.345|0.6528
91674426|NCT03919162|183242242|SUPERIORITY||Difference LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.101||0.3241|TWO_SIDED|95.0|-0.103|0.303||The secondary analysis used a mixed model for repeated measures (MMRM) with the within-participant change compared between active arm and placebo in ABC as the outcome.|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline ABC score, time, treatment group, time by treatment group interaction|Treatment difference = PQ912 - Placebo|A hierarchical approach is taken: If the primary and key secondary endpoint are both statistically significant the remaining secondary endpoints will be tested in the hierarchical order defined per Statistical Analysis Plan until a non-significant result is encountered: Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite Score, Quantitative EEG, Functional Activities Questionnaire, Alzheimer's Disease Assessment Scale - Cognitive Subscale 13, Neuropsychiatric Inventory.||0.303|-0.103|0.3241
91674427|NCT03919162|183242243|SUPERIORITY||Difference LS Mean|-0.02857|STANDARD_ERROR_OF_MEAN|0.01846||0.1398|TWO_SIDED|95.0|-0.06746|0.01032||The secondary analysis used a mixed model for repeated measures (MMRM) with the within-participant change compared between active arm and placebo in qEEG as the outcome.|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline qECG data, time, treatment group, time by treatment group interaction|Treatment difference = PQ912 - Placebo|A hierarchical approach is taken: If the primary and key secondary endpoint are both statistically significant the remaining secondary endpoints will be tested in the hierarchical order defined per Statistical Analysis Plan until a non-significant result is encountered: Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite Score, Quantitative EEG, Functional Activities Questionnaire, Alzheimer's Disease Assessment Scale - Cognitive Subscale 13, Neuropsychiatric Inventory.||0.01032|-0.06746|0.1398
91674428|NCT03919162|183242244|SUPERIORITY||Difference LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|1.79||0.7377|TWO_SIDED|95.0|-4.22|3.01||The analysis used a mixed model for repeated measures (MMRM) with the within-participant change compared between active arm and placebo in FAQ as the outcome.|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline FAQ score, time, treatment group, time by treatment group interaction.|Treatment difference = PQ912 - Placebo|A hierarchical approach is taken: If the primary and key secondary endpoint are both statistically significant the remaining secondary endpoints will be tested in the hierarchical order defined per Statistical Analysis Plan until a non-significant result is encountered: Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite Score, Quantitative EEG, Functional Activities Questionnaire, Alzheimer's Disease Assessment Scale - Cognitive Subscale 13, Neuropsychiatric Inventory.||3.01|-4.22|0.7377
91674429|NCT03919162|183242245|SUPERIORITY||Difference LS Mean|2.034|STANDARD_ERROR_OF_MEAN|2.154||0.3496|TWO_SIDED|95.0|-2.292|6.36||The secondary analysis used a mixed model for repeated measures (MMRM) with the within-participant change compared between active arm and placebo in ADAS-Cog-13 as the outcome.|Mixed Models Analysis|Fixed effect covariates: APOE status, initial diagnosis, site, baseline ADAS-Cog-13 score, time, treatment group, time by treatment group interaction|Treatment difference = PQ912 - Placebo|A hierarchical approach is taken: If the primary and key secondary endpoint are both statistically significant the remaining secondary endpoints will be tested in the hierarchical order defined per Statistical Analysis Plan until a non-significant result is encountered: Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite Score, Quantitative EEG, Functional Activities Questionnaire, Alzheimer's Disease Assessment Scale - Cognitive Subscale 13, Neuropsychiatric Inventory.||6.360|-2.292|0.3496
91692157|NCT03296527|183279340|OTHER||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-0.9|10.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer||10.7|-0.9|
91692158|NCT03296527|183279341|OTHER||Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-1.5|9.8|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer||9.8|-1.5|
91716740|NCT00473083|183325291|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Chi-squared|||Maximal Severity Grade 3||||0.0344
91716741|NCT00473083|183325292|SUPERIORITY_OR_OTHER|||||||0.3834|||||||Log Rank|||||||0.3834
91485787|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.901||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.901
91674430|NCT03919162|183242246|SUPERIORITY||Difference LS Mean|-3.09|STANDARD_ERROR_OF_MEAN|2.34||0.1933|TWO_SIDED|95.0|-7.81|1.62||The secondary analysis used a mixed model for repeated measures (MMRM) with the within-participant change compared between active arm and placebo in NPI as the outcome.|Mixed Models Analysis||Treatment difference = PQ912 - Placebo|A hierarchical approach is taken: If the primary and key secondary endpoint are both statistically significant the remaining secondary endpoints will be tested in the hierarchical order defined per Statistical Analysis Plan until a non-significant result is encountered: Alzheimer's Disease Neuroimaging Initiative (ADNI) Battery Composite Score, Quantitative EEG, Functional Activities Questionnaire, Alzheimer's Disease Assessment Scale - Cognitive Subscale 13, Neuropsychiatric Inventory.||1.62|-7.81|0.1933
91674431|NCT03078478|183242253|SUPERIORITY||Treatment rate ratio|0.88||||0.1715|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|||The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.||1.06|0.73|0.1715
91674432|NCT03861481|183242290|SUPERIORITY||LS Mean difference (Rozimab - Placebo)|-0.052|||||TWO_SIDED|90.0|-0.892|0.788|||||MMRM analysis (fixed effect terms: treatment, baseline iRODS score, prior Ig therapy administration route, assessment week, treatment by week interaction; random effect term: study participant). LS Mean Difference \> 0 favours rozanolixizumab.|||0.788|-0.892|
91674433|NCT00773734|183242291|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.6||||0.1846|TWO_SIDED|95.0|-2.6|13.7|||Chi-squared|||||13.7|-2.6|0.1846
91674434|NCT00773734|183242291|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7|||Chi-squared|||||33.7|12.4|<0.0001
91674435|NCT00773734|183242291|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|23.9|46.6|||Chi-squared|||||46.6|23.9|<0.0001
91674436|NCT00773734|183242293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.2||||0.059|TWO_SIDED|95.0|-0.4|26.8|||Chi-squared|||||26.8|-0.4|0.0590
91674437|NCT00773734|183242293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|22.1||||0.0023|TWO_SIDED|95.0|8.3|36.0|||Chi-squared|||||36.0|8.3|0.0023
91716742|NCT00473083|183325294|SUPERIORITY_OR_OTHER|||||||0.0147|||||||Wilcoxon (Mann-Whitney)|||||||0.0147
91485788|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.840
91674438|NCT00773734|183242293|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|21.6|48.9|||Chi-squared|||||48.9|21.6|<0.0001
91674439|NCT00773734|183242295|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.4||||0.1776|TWO_SIDED|95.0|-1.5|8.2|||Chi-squared|||||8.2|-1.5|0.1776
91674440|NCT00773734|183242295|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.1||||0.0158|TWO_SIDED|95.0|1.6|14.5|||Chi-squared|||||14.5|1.6|0.0158
91674441|NCT00773734|183242295|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.2||||0.0051|TWO_SIDED|95.0|3.2|17.2|||Chi-squared|||||17.2|3.2|0.0051
91674442|NCT00773734|183242300|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7||||0.0156|TWO_SIDED|95.0|-24.8|-2.6|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.6|-24.8|0.0156
91674443|NCT00773734|183242300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.4|-13.9|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-13.9|-36.4|<0.0001
91674444|NCT00773734|183242300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.0|-21.7|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-21.7|-44.0|<0.0001
91674445|NCT00773734|183242302|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||0.6541|TWO_SIDED|95.0|-11.7|7.3|||Chi-squared|||||7.3|-11.7|0.6541
91674446|NCT00773734|183242302|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.4||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Chi-squared|||||24.1|0.6|0.0402
91674447|NCT00773734|183242302|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.1||||0.0011|TWO_SIDED|95.0|8.8|33.4|||Chi-squared|||||33.4|8.8|0.0011
91674448|NCT00773734|183242306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.2||||0.002|TWO_SIDED|95.0|-33.0|-7.5|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-7.5|-33.0|0.0020
91674449|NCT00773734|183242306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-42.9|-17.0|||ANCOVA|based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-17.0|-42.9|<0.0001
91674450|NCT00773734|183242306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-42.4|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.5||Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|ANCOVA|||||-29.5|-55.2|<0.0001
91674451|NCT00773734|183242308|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.1322|TWO_SIDED|95.0|-3.1|0.4|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||0.4|-3.1|0.1322
91674452|NCT00773734|183242308|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.9|-2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.3|-5.9|<0.0001
91674453|NCT00773734|183242308|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.6||||0.0047|TWO_SIDED|95.0|-4.3|-0.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-0.8|-4.3|0.0047
91716743|NCT03924323|183325316|SUPERIORITY||least squares mean difference|-1.42||||0.0281|TWO_SIDED|95.0|-2.69|-0.15|||mixed-effects model for repeated measure|||||-0.15|-2.69|0.0281
91716744|NCT03924323|183325317|SUPERIORITY||Odds Ratio (OR)|1.253||||0.4521|TWO_SIDED|95.0|0.695|2.258|||generalized linear mixed model (GLMMIX)|||||2.258|0.695|0.4521
91716745|NCT03924323|183325318|SUPERIORITY||Odds Ratio (OR)|1.157||||0.6928|TWO_SIDED|95.0|0.56|2.387|||generalized linear mixed model (GLMMIX)|||||2.387|0.560|0.6928
91716746|NCT03903172|183325321|SUPERIORITY||||||=|0.25|||||||t-test, 2 sided|||Day 0||||=0.25
91716747|NCT03903172|183325321|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Day 1||||=.93
91716748|NCT03903172|183325322|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used acetominophen||||=1.0
91716749|NCT03903172|183325322|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used ibuprofen||||=1.0
91716750|NCT03903172|183325322|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used Cyclobenzaprine||||=1.0
91641079|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.375|TWO_SIDED|95.0|-0.41|1.08|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.08|-0.41|0.375
91641080|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.028|TWO_SIDED|95.0|0.07|1.27|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.27|0.07|0.028
91641081|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.188|TWO_SIDED|95.0|-0.18|0.92|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.18|0.188
91641082|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.375|TWO_SIDED|95.0|-0.97|0.37|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.37|-0.97|0.375
91641083|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.552|TWO_SIDED|95.0|-0.47|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.89|-0.47|0.552
91641084|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.126|TWO_SIDED|95.0|-0.14|1.12|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.12|-0.14|0.126
91641085|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.46|TWO_SIDED|95.0|-0.47|1.05|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.05|-0.47|0.460
91641086|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.095|TWO_SIDED|95.0|-0.09|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.09|0.095
91641087|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.146|TWO_SIDED|95.0|-0.14|0.94|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.14|0.146
91641088|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.769|TWO_SIDED|95.0|-0.75|0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.56|-0.75|0.769
91641089|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.405|TWO_SIDED|95.0|-0.39|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.39|0.405
91641090|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.073|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.20|-0.05|0.073
91641091|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.458|TWO_SIDED|95.0|-0.47|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.04|-0.47|0.458
91641092|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.009|TWO_SIDED|95.0|0.2|1.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.39|0.20|0.009
91641093|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.209|TWO_SIDED|95.0|-0.2|0.9|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.90|-0.20|0.209
91641094|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-1.11|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.22|-1.11|0.193
91485789|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.882
91485790|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.225
91485791|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.340
91674454|NCT00773734|183242310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.3||||0.0078|TWO_SIDED|95.0|0.9|5.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||5.8|0.9|0.0078
91674455|NCT00773734|183242310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.5||||0.0068|TWO_SIDED|95.0|1.0|6.0|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.0|1.0|0.0068
91674456|NCT00773734|183242310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.6||||0.0045|TWO_SIDED|95.0|1.1|6.1|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.1|1.1|0.0045
91674457|NCT00773734|183242311|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6097|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.8|-1.6|0.6097
91674458|NCT00773734|183242311|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.3||||0.2424|TWO_SIDED|95.0|-0.9|3.6|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||3.6|-0.9|0.2424
91674459|NCT00773734|183242311|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.9528|TWO_SIDED|95.0|-2.2|2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.3|-2.2|0.9528
91674460|NCT02678442|183242501|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91674461|NCT02678442|183242503|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91674462|NCT02678442|183242504|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91674463|NCT02678442|183242505|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
91674464|NCT00391079|183242517|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.17||||0.468|TWO_SIDED|95.0|-0.62|0.29|||ANCOVA|||The change in pain NRS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.29|-0.62|0.468
91674465|NCT00391079|183242518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.309||||0.2338|TWO_SIDED|95.0|0.84|2.038|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each Sativex and placebo.||2.038|0.840|0.2338
91674466|NCT00391079|183242519|SUPERIORITY_OR_OTHER||Estimated treatment effect|-1.83||||0.3103|TWO_SIDED|95.0|-5.39|1.72|||ANOVA||A negative difference in estimated treatment effect indicates an improvement in pain in favour of Sativex.|The change in NPS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||1.72|-5.39|0.3103
91674467|NCT00391079|183242520|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.24||||0.1567|TWO_SIDED|95.0|-0.57|0.09|||ANCOVA||A negative difference in estimated treatment difference indicates a reduction in breakthrough analgesic medication in favour of Sativex.|The change in average number of tablets taken daily from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.09|-0.57|0.1567
91674468|NCT00391079|183242521|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.5643|TWO_SIDED|95.0|-0.53|0.29|||ANCOVA||A negative difference in estimated means indicates an improvement in pain in favour of Sativex.|||0.29|-0.53|0.5643
91674469|NCT00391079|183242522|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.47||||0.0552|TWO_SIDED|95.0|0.991|2.179|||Regression, Logistic||An odds ratio of greater than 1 indicates and improvement in favour of Sativex.|||2.179|0.991|0.0552
91674470|NCT00391079|183242523|SUPERIORITY_OR_OTHER||estimated treatment difference|0.05||||0.833|TWO_SIDED|95.0|-0.39|0.48|||ANCOVA||A negative difference in estimated treatment difference indicates an improvement in sleep quality in favour of Sativex.|||0.48|-0.39|0.8330
91674471|NCT01744093|183242533|OTHER|Descriptive proportion|Proportion (percent)|18.8|||||TWO_SIDED|95.0|4.0|45.6|||||Exact two-sided 95% Clopper-Pearson confidence interval.|||45.6|4.0|
91674472|NCT01744093|183242534|SUPERIORITY||Proportion (percent)|6.3||||0.002|TWO_SIDED|95.0|0.16|30.2|||Fisher Exact||Exact two-sided 95% Clopper-Pearson confidence interval.|Null hypothesis adverse event rate (grade 2 or higher toxicity) = 45.5%||30.2|0.16|0.002
91674473|NCT02006628|183242539|SUPERIORITY||Treatment difference (GWP42003-placebo)|-2.8||||0.1332|TWO_SIDED|95.0|-6.5|0.9|||ANCOVA|Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.||||0.9|-6.5|0.1332
91674474|NCT02006628|183242540|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0896|TWO_SIDED|95.0|0.86|8.0|||Regression, Logistic|Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.||||8.00|0.86|0.0896
91674475|NCT02006628|183242541|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.4||||0.0188|TWO_SIDED|95.0|-2.5|-0.2|||ANCOVA|||||-0.2|-2.5|0.0188
91674476|NCT02006628|183242542|SUPERIORITY||Treatment difference (GWP42003-placebo)|0.0||||0.9647|TWO_SIDED|95.0|-1.3|1.4|||ANCOVA|||||1.4|-1.3|0.9647
91674477|NCT02006628|183242543|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.3||||0.1963|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|||||0.7|-3.2|0.1963
91674478|NCT02006628|183242544|SUPERIORITY||Treatment difference (GWP42003-placebo)|-3.5||||0.1167|TWO_SIDED|95.0|-7.9|0.9|||ANCOVA|||||0.9|-7.9|0.1167
91641095|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.149|TWO_SIDED|95.0|-0.18|1.18|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.18|-0.18|0.149
91641096|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.21|1.06|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.06|-0.21|0.186
91641097|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.845|TWO_SIDED|95.0|-0.84|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.84|0.845
91641098|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.14|-0.04|0.067
91641099|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.242|TWO_SIDED|95.0|-0.22|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.22|0.242
91641100|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.498|TWO_SIDED|95.0|-0.88|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.43|-0.88|0.498
91674479|NCT02006628|183242545|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.3||||0.0443|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||||0.0|-0.5|0.0443
91674480|NCT02006628|183242546|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.5||||0.0182|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.0182
91716751|NCT03903172|183325322|SUPERIORITY||||||=|0.11|||||||Fisher Exact|||Used Methocarbamol||||=.11
91641101|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.33|TWO_SIDED|95.0|-0.34|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.34|0.330
91641102|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.124|TWO_SIDED|95.0|-0.14|1.13|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.14|0.124
91641103|NCT01945034|183173607|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.687|TWO_SIDED|95.0|-0.61|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.92|-0.61|0.687
91641104|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.166|TWO_SIDED|95.0|-0.85|4.95|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.95|-0.85|0.166
91641105|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.199|TWO_SIDED|95.0|-4.42|0.93|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-4.42|0.199
91641106|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8||||0.022|TWO_SIDED|95.0|-7.04|-0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.56|-7.04|0.022
91641107|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.26|TWO_SIDED|95.0|-1.3|4.79|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.79|-1.30|0.260
91674481|NCT02006628|183242547|SUPERIORITY||Treatment difference (GWP42003-placebo)|1.31||||0.0677|TWO_SIDED|95.0|-0.1|2.72|||ANCOVA|||||2.72|-0.10|0.0677
91674482|NCT00834652|183242548|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91674483|NCT01173471|183242563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|5.352||0.822|TWO_SIDED|95.0|-15.2|12.6|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||12.6|-15.2|0.822
91674484|NCT01173471|183242563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.516||0.413|TWO_SIDED|95.0|-10.1|4.3|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||4.3|-10.1|0.413
91674485|NCT01173471|183242565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.57||0.758|TWO_SIDED|95.0|-4.8|3.7|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||3.7|-4.8|0.758
91674486|NCT01173471|183242565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.909||0.467|TWO_SIDED|95.0|-2.5|1.2|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||1.2|-2.5|0.467
91716752|NCT03903172|183325322|SUPERIORITY||||||=|0.49|||||||Fisher Exact|||Used Hydroxyzine||||=.49
91716753|NCT03903172|183325322|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used an 'Other' non-pharmacologic medication||||=1.0
91716754|NCT03903172|183325323|SUPERIORITY||||||=|1|||||||Fisher Exact|||Any narcotic medication used||||=1.0
91716755|NCT01545388|183325324|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.678|||<|0.001|TWO_SIDED|95.0|-0.868|-0.489|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.489|-0.868|<0.001
91716756|NCT01545388|183325324|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.525|||<|0.001|TWO_SIDED|95.0|-0.713|-0.337|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.337|-0.713|<0.001
91716757|NCT01545388|183325324|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin (Δ) is set as 0.3% to show the non-inferiority of metformin 500 mg q.d. to metformin 250 mg b.i.d.|Difference in least squares means|0.153|||||TWO_SIDED|95.0|0.0|0.306||||||||0.306|0.000|
91716758|NCT01545388|183325325|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.59|||<|0.001|TWO_SIDED|95.0|-25.94|-11.24|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-11.24|-25.94|<0.001
91716759|NCT01545388|183325325|SUPERIORITY_OR_OTHER||Difference in least squares means|-16.34|||<|0.001|TWO_SIDED|95.0|-23.62|-9.06|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-9.06|-23.62|<0.001
91716760|NCT01545388|183325325|SUPERIORITY_OR_OTHER||Difference in least squares mean|2.25|||||TWO_SIDED|95.0|-3.63|8.14||||||||8.14|-3.63|
91716761|NCT01474486|183325333|OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
91716762|NCT01255163|183325341|OTHER|||||||0.016||||||threshold for significance (p \< 0.05)|Fisher Exact|||||||0.016
91793256|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence|Slope|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Baseline COST effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||-0.3|-0.6|<0.001
91716763|NCT01255163|183325342|OTHER|||||||0.098||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects Group \* VisitLong F (6, 52.008) = 1.902, p = 0.098"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED MMSE.tot BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.098
91716764|NCT01255163|183325343|OTHER|||||||0.295||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects for Group\*VisitLong F (6, 52.281) = 1.254, p = 0.295"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED ADAS70 BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.295
91716765|NCT01255163|183325344|OTHER|||||||0.141||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (6, 47.485) = 1.704, p = 0.141|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.141
91716766|NCT01255163|183325345|OTHER|||||||0.031||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects: Group \* VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR.sob BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.031
91716767|NCT01255163|183325346|OTHER|||||||0.703||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.251) = 0.360, p = 0.703.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED TAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.703
91674487|NCT03998436|183242581|SUPERIORITY||Odds Ratio (OR)|2.126||||0.0276|TWO_SIDED|95.0|1.08|4.17|||Chi-squared|||||4.17|1.08|0.0276
91674488|NCT03998436|183242582|SUPERIORITY||Odds Ratio (OR)|2.708||||0.0126|TWO_SIDED|95.0|1.22|5.99|||Chi-squared|||||5.99|1.22|0.0126
91674489|NCT04323098|183242598|SUPERIORITY|||||||0.0057||||||P-value was based on two-sided t-test against 0.|t-test, 2 sided|||||||0.0057
91527863|NCT06173570|182930695|SUPERIORITY||Mean Difference (Net)|-6.32||||0.243|TWO_SIDED|95.0|-16.92|4.29|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||4.29|-16.92|0.243
91674490|NCT04572243|183242610|SUPERIORITY||Median Difference (Final Values)|-86.08|||||TWO_SIDED|95.0|-144.01|-28.14||||||||-28.14|-144.01|
91674491|NCT04572243|183242611|SUPERIORITY||Odds Ratio (OR)|6.0|||||TWO_SIDED|95.0|0.81|44.35||||||||44.35|0.81|
91674492|NCT04179019|183242625|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||The intra-individual, paired, 24h urine aldosterone excretion rate following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment 24h urine aldosterone excretion rate. The null hypothesis was that amlodipine therapy would result in no change in the 24h urine aldosterone excretion rate. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.96
91674493|NCT04179019|183242626|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||The intra-individual, paired, plasma aldosterone concentration following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment aldosterone concentration. The null hypothesis was that amlodipine therapy would result in no change in the plasma aldosterone value. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.29
91674494|NCT04179019|183242627|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||The intra-individual, paired, change in plasma aldosterone concentration in response to an acute dose of amlodipine (6h post-dose) was compared to the baseline pre-treatment response to an acute dose of amlodipine. The null hypothesis was that an acute amlodipine dose would result in no acute change in the plasma aldosterone levels. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.83
91674495|NCT03179163|183242641|OTHER||Mean Difference (Net)|0.01|||=|0.01|TWO_SIDED||||||ANOVA|||A priori power analysis (power = 0.80,a= 0.05) confirmed a sample size of n= 10 was needed to determine a meaningful difference of 10% in the (flux/MAP)\*logAch(mol/L) . All data were analyzed with repeated-measures ANOVA . When appropriate, post hoc Tukey-Kramer corrections were applied to correct for multiple comparisons. Significance was set a priori at a\<0.05.||||=0.01
91674496|NCT02858726|183242651|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-2.8|<0.001
91674497|NCT02858726|183242651|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.107|TWO_SIDED|95.0|-1.9|0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||0.2|-1.9|0.107
91674498|NCT02858726|183242651|SUPERIORITY||Median Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.5||0.019|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.2|-2.3|0.019
91674499|NCT02858726|183242652|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-16.0|-4.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-4.8|-16.0|<0.001
91674500|NCT02858726|183242652|SUPERIORITY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|3.0||0.016|TWO_SIDED|95.0|-13.1|-1.4|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-1.4|-13.1|0.016
91674501|NCT02858726|183242652|SUPERIORITY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|95.0|-12.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-12.8|0.026
91674502|NCT02508259|183242660|EQUIVALENCE|The null hypothesis was that before and after treatment ADOS scores were equivalent.|Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.55||0.0028|TWO_SIDED|95.0|-2.3|-0.9|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.9|-2.3|0.0028
91674503|NCT02508259|183242661|EQUIVALENCE|The child-specific difference in EOWPVT scores were compared for equivalence before and 6-weeks after suramin treatment|Mean Difference (Net)|-4.2|STANDARD_DEVIATION|8.3||0.32|TWO_SIDED|95.0|-14.5|6.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||6.1|-14.5|0.32
91674504|NCT02508259|183242662|EQUIVALENCE|In this analysis, the null hypothesis was tested that the child-specific ABC subscores for stereotypy were unchanged before and after suramin treatment.|Mean Difference (Net)|-4.0|STANDARD_DEVIATION|2.3||0.019|TWO_SIDED|95.0|-6.9|-1.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-1.1|-6.9|0.019
91716768|NCT01255163|183325347|OTHER|||||||0.845||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.828) = 0.170, p = 0.845.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED pTAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.845
91722541|NCT02629159|183337904|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.63|-3.27||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-3.27|-9.63|<0.001
91485792|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.850
91641108|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.729|TWO_SIDED|95.0|-3.31|2.32|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||2.32|-3.31|0.729
91641109|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2||||0.196|TWO_SIDED|95.0|-5.64|1.16|||ANOVA|||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||1.16|-5.64|0.196
91641110|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|24.9||||0.03|TWO_SIDED|95.0|2.49|47.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||47.28|2.49|0.030
91641111|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2||||0.018|TWO_SIDED|95.0|-55.24|-5.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-5.23|-55.24|0.018
91641112|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.611|TWO_SIDED|95.0|-25.98|15.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||15.29|-25.98|0.611
91641113|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|13.8||||0.251|TWO_SIDED|95.0|-9.8|37.36|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||37.36|-9.80|0.251
91641114|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4||||0.689|TWO_SIDED|95.0|-17.37|26.26|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||26.26|-17.37|0.689
91641115|NCT01945034|183173608|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.3||||0.486|TWO_SIDED|95.0|-35.69|17.01|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||17.01|-35.69|0.486
91485793|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.447
91485794|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.909||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.909
91641116|NCT01945034|183173609|SUPERIORITY_OR_OTHER||LS Mean Difference|38.5||||0.021|TWO_SIDED|95.0|5.9|71.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||71.18|5.90|0.021
91641117|NCT01945034|183173609|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9||||0.603|TWO_SIDED|95.0|-38.02|22.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||22.12|-38.02|0.603
91641118|NCT01945034|183173609|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5||||0.013|TWO_SIDED|95.0|-82.93|-10.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-10.05|-82.93|0.013
91716769|NCT01255163|183325348|OTHER|||||||0.018||||||Type III Tests of Fixed Effects: Group \* VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED Ab42 BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.018
91716770|NCT01255163|183325349|OTHER|||||||0.009||||||Type III Tests of Fixed Effects: Group \* VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED BMI BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.009
91716771|NCT02495389|183325366|SUPERIORITY||Mean Difference (Final Values)|23.96|STANDARD_ERROR_OF_MEAN|2.7741|<|0.0001|TWO_SIDED|95.0|18.35|29.57|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score after 12 weeks of therapy.||29.57|18.35|<.0001
91716772|NCT02495389|183325367|SUPERIORITY||Mean Difference (Final Values)|-51.62|STANDARD_ERROR_OF_MEAN|6.1584|<|0.0001|TWO_SIDED|95.0|-64.04|-39.2|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Urinary Distress Inventory score after 12 weeks of therapy.||-39.20|-64.04|<.0001
91716773|NCT02495389|183325368|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|5.4701|<|0.0001|TWO_SIDED|95.0|-40.33|-18.27|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Pelvic Organ Prolapse Distress Inventory score after 12 weeks of therapy.||-18.27|-40.33|<.0001
91716774|NCT02495389|183325369|SUPERIORITY||Mean Difference (Final Values)|-32.0|STANDARD_ERROR_OF_MEAN|6.1226|<|0.0001|TWO_SIDED|95.0|-44.35|-19.65|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Colo-Rectal-Anal Distress Inventory score after 12 weeks of therapy.||-19.65|-44.35|<.0001
91716775|NCT01924533|183325370|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0262|TWO_SIDED|97.5|0.63|1.0|||Cox proportional hazards model|||||1.00|0.63|0.0262
91485795|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.152
91485796|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.023
91716776|NCT01924533|183325371|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.2458|TWO_SIDED|97.5|0.4|1.34|||Cox proportional hazards model|||||1.34|0.40|0.2458
91716777|NCT01924533|183325372|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0645|TWO_SIDED|97.5|0.67|1.04|||Cox proportional hazards model|||||1.04|0.67|0.0645
91716778|NCT01924533|183325373|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.2199|TWO_SIDED|97.5|0.42|1.29|||Cox proportional hazards model|||||1.29|0.42|0.2199
91716779|NCT01924533|183325374|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.69||||0.0548|TWO_SIDED|97.5|0.92|3.17|||Regression, Logistic|||||3.17|0.92|0.0548
91716780|NCT01924533|183325375|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.24||||0.0309|TWO_SIDED|97.5|0.95|23.23|||Regression, Logistic|||||23.23|0.95|0.0309
91716781|NCT01924533|183325376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0716|TWO_SIDED|97.5|0.64|1.05|||Cox proportional hazards model|||||1.05|0.64|0.0716
91716782|NCT01924533|183325377|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0927|TWO_SIDED|97.5|0.34|1.16|||Cox proportional hazards model|||||1.16|0.34|0.0927
91716783|NCT04233879|183325396|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-4.5|5.8|||||Unstratified Miettinen and Nurminen method was used to generate the treatment difference and the associated 95%CI.|||5.8|-4.5|
91716784|NCT04233879|183325397|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.3|||||TWO_SIDED|95.0|-0.8|9.6|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||9.6|-0.8|
91716785|NCT04233879|183325398|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.0|||||TWO_SIDED|95.0|0.4|7.9|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||7.9|0.4|
91716786|NCT04233879|183325401|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|2.3|||||TWO_SIDED|95.0|-3.1|7.7|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||7.7|-3.1|
91485797|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.004
91527864|NCT06173570|182930696|SUPERIORITY||Mean Difference (Net)|-1.3||||0.501|TWO_SIDED|95.0|-5.08|2.48|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||2.48|-5.08|0.501
91641119|NCT01945034|183173610|SUPERIORITY_OR_OTHER||LS Mean Difference|87.7||||0.021|TWO_SIDED|95.0|13.48|161.85|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||161.85|13.48|0.021
91641120|NCT01945034|183173610|SUPERIORITY_OR_OTHER||LS Mean Difference|11.8||||0.735|TWO_SIDED|95.0|-56.59|80.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||80.11|-56.59|0.735
91641121|NCT01945034|183173610|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.9||||0.072|TWO_SIDED|95.0|-158.73|6.93|||ANOVA|||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||6.93|-158.73|0.072
91641122|NCT01945034|183173610|SUPERIORITY_OR_OTHER||LS Mean Difference|46.0||||0.261|TWO_SIDED|95.0|-34.43|126.52|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||126.52|-34.43|0.261
91641123|NCT01945034|183173610|SUPERIORITY_OR_OTHER||LS Mean Difference|37.3||||0.325|TWO_SIDED|95.0|-37.13|111.8|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||111.80|-37.13|0.325
91641124|NCT01945034|183173610|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7||||0.849|TWO_SIDED|95.0|-98.64|81.22|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||81.22|-98.64|0.849
91641125|NCT01945034|183173611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.042|TWO_SIDED|95.0|0.0|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.49|0.0|0.042
91674505|NCT02508259|183242663|EQUIVALENCE|In this analysis, we tested the equivalence of the child-specific ATEC subscore for language before and 6-weeks after treatment with suramin.|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|1.4||0.034|TWO_SIDED|95.0|-2.7|-0.49|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.49|-2.7|0.034
91674506|NCT02508259|183242664|EQUIVALENCE|In this analysis, overall ASD symptom scores, measured by CGI were compared between suramin and placebo groups.|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.04||0.05|TWO_SIDED|95.0|-3.4|-0.15|||ANOVA|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.15|-3.4|0.05
91674507|NCT02508259|183242665|EQUIVALENCE|In this analysis, the child-specific RBQ score was tested for equivalence before and 6-weeks after suramin treatment.|Mean Difference (Net)|-3.2|STANDARD_DEVIATION|5.8||0.28|TWO_SIDED|95.0|-10.4|4.0|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||4.0|-10.4|0.28
91716787|NCT04233879|183325402|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|1.0|||||TWO_SIDED|95.0|-4.1|6.1|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||6.1|-4.1|
91641126|NCT01945034|183173611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.114|TWO_SIDED|95.0|-0.04|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.04|0.114
91641127|NCT01945034|183173611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.598|TWO_SIDED|95.0|-0.34|0.2|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.20|-0.34|0.598
91674508|NCT06400745|183242674|NON_INFERIORITY|Study success will be concluded if the upper bound of the one-sided 95.1% confidence interval does not exceed the noninferiority margin of 0.1 logMAR.|Difference in Means|0.009|STANDARD_ERROR_OF_MEAN|0.0085|||ONE_SIDED|95.1||0.0232||The upper boundary of the confidence interval is reported instead of a p-value.|t-test, 1 sided|The upper bound of the one-sided 95.1% confidence limit will be compared to the margin, 0.10 logMAR.|Difference in Means = CPO Pro IOL minus CPO|||0.0232||
91674509|NCT00710749|183242675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44||95.0|||||Wilcoxon signed rank test|||||||0.44
91674510|NCT00710749|183242675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
91674511|NCT00710749|183242675|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
91674512|NCT05478252|183242676|NON_INFERIORITY|Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS.|Treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.3|0.08|||ANCOVA|||||0.08|-0.30|<.0001
91674513|NCT04846881|183242685|SUPERIORITY||Mean Difference (Net)|0.722|STANDARD_ERROR_OF_MEAN|0.4753||0.1291|TWO_SIDED|95.0|-0.211|1.656|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors.|Adjusted mean difference in overall composite T-score of the MCCB at Week 26 between the iclepertin 10 mg and the Placebo group.|The model included fixed categorical effects of treatment at each visit and the stratification factor (screening MCCB overall composite T-score) and fixed effects for the continuous covariate of baseline at each visit. Visit was treated as a repeated measure with unstructured covariance structure for within-participant dependencies. The primary comparison was iclepertin 10 mg daily vs. placebo at Week 26.||1.656|-0.211|0.1291
91674514|NCT04846881|183242686|SUPERIORITY||Mean Difference (Net)|0.714|STANDARD_ERROR_OF_MEAN|0.6042||0.2375|TWO_SIDED|95.0|-0.472|1.901|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors.|Adjusted mean difference in SCoRS at Week 26 between the iclepertin 10 mg and the Placebo group.|The model included the discrete fixed effects of treatment at each visit, fixed categorical covariate of the stratification factor using the screening MCCB overall composite T-score, and continuous fixed effects for the corresponding baseline endpoint value at each visit. Visit was treated as the repeated measure with an unstructured covariance structure to model the within-subject measurements. Subjects were considered as a random effect.||1.901|-0.472|0.2375
91674515|NCT04846881|183242687|SUPERIORITY||Mean Difference (Net)|0.333|STANDARD_ERROR_OF_MEAN|1.062||0.7541|TWO_SIDED|95.0|-1.753|2.419|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors.|Adjusted mean difference in VRFCAT at Week 26 between the iclepertin 10 mg and the Placebo group.|The model included the discrete fixed effects of treatment at each visit, fixed categorical covariate of the stratification factor using the screening MCCB overall composite T-score, and continuous fixed effects for the corresponding baseline endpoint value at each visit. Visit was treated as the repeated measure with an unstructured covariance structure to model the within-subject measurements. Subjects were considered as a random effect.||2.419|-1.753|0.7541
91674516|NCT04846881|183242688|SUPERIORITY||Mean Difference (Net)|0.012|STANDARD_ERROR_OF_MEAN|0.044||0.7769|TWO_SIDED|95.0|-0.074|0.099|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors.|Adjusted mean difference in PRECIS at Week 24 between the iclepertin 10 mg and the Placebo group.|The model included the discrete fixed effects of treatment at each visit, fixed categorical covariate of the stratification factor using the screening MCCB overall composite T-score, and continuous fixed effects for the corresponding baseline endpoint value at each visit. Visit was treated as the repeated measure with an unstructured covariance structure to model the within-subject measurements. Subjects were considered as a random effect.||0.099|-0.074|0.7769
91674517|NCT04846881|183242689|SUPERIORITY||Mean Difference (Net)|-1.135|STANDARD_ERROR_OF_MEAN|0.911||0.2133|TWO_SIDED|95.0|-2.925|0.654|||ANCOVA||Adjusted mean difference in ToL at Week 26 between the iclepertin 10 mg and the Placebo group.|For change from baseline to Week 26 in the T-score of the number of correct responses on ToL, an analysis of covariance (ANCOVA) model including treatment, stratification factor of screening MCCB overall composite T-score (\<30, ≥30), and baseline number of correct responses on ToL T-score were fitted to the data.||0.654|-2.925|0.2133
91674518|NCT04560998|183242690|SUPERIORITY||The Hodges-Lehmann estimate|1.13||||0.0004|TWO_SIDED|95.0|1.056|1.211|||Wilcoxon (Mann-Whitney)|||||1.211|1.056|0.0004
91485798|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.017
91485799|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.944
91674519|NCT04560998|183242691|SUPERIORITY||The Hodges-Lehmann estimate|1.08||||0.038|TWO_SIDED|95.0|1.004|1.156|||Wilcoxon (Mann-Whitney)|||||1.156|1.004|0.0380
91674520|NCT04560998|183242692|SUPERIORITY||The Hodges-Lehmann estimate|1.0||||0.0108|TWO_SIDED|95.0|0.478|1.518|||Wilcoxon (Mann-Whitney)|||||1.518|0.478|0.0108
91674521|NCT04560998|183242693|SUPERIORITY||The Hodges-Lehmann Estimate|1.11||||0.0046|TWO_SIDED|95.0|1.033|1.197|||Wilcoxon (Mann-Whitney)|||||1.197|1.033|0.0046
91674522|NCT04495283|183242749|SUPERIORITY||LS Mean Difference|-114.43|STANDARD_ERROR_OF_MEAN|26.65|<|0.001|ONE_SIDED|90.0||-80.01|||ANOVA|||||-80.01||<0.001
91674523|NCT04495283|183242750|SUPERIORITY||LS Mean Difference|-70.16|STANDARD_ERROR_OF_MEAN|21.549|<|0.001|ONE_SIDED|90.0||-42.32|||ANOVA|||||-42.32||<0.001
91674524|NCT04843566|183242779|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
91674525|NCT04843566|183242779|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
91674526|NCT04843566|183242779|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
91674527|NCT04843566|183242780|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Immediately following biopsy - Pain||||0.002
91674528|NCT04843566|183242780|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Immediately following biopsy - Discomfort||||0.05
91674529|NCT04843566|183242780|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||7-day post biopsy - Pain||||<0.0001
91674530|NCT04843566|183242780|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||7-day post biopsy - Discomfort||||0.07
91674531|NCT04843566|183242781|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
91674532|NCT04843566|183242782|SUPERIORITY|||||||0.59|||||||Chi-squared|||Gleason grade \>=2||||0.59
91674533|NCT04843566|183242783|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
91674534|NCT04843566|183242783|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
91641128|NCT01945034|183173611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.19|-0.24|0.833
91485800|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.677
91641129|NCT01945034|183173611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.853|TWO_SIDED|95.0|-0.18|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.18|0.853
91641130|NCT01945034|183173611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.733|TWO_SIDED|95.0|-0.2|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.29|-0.20|0.733
91641131|NCT01945034|183173613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.016|TWO_SIDED|95.0|1.07|1.97|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.||1.97|1.07|0.016
91641132|NCT01945034|183173613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.022|TWO_SIDED|95.0|0.53|0.95|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.95|0.53|0.022
91641133|NCT01945034|183173613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.34|0.69|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.69|0.34|< 0.001
91674535|NCT04843566|183242783|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
91641134|NCT01945034|183173613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.001|TWO_SIDED|95.0|1.27|2.51|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||2.51|1.27|< 0.001
91641135|NCT01945034|183173613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.009|TWO_SIDED|95.0|0.41|0.88|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.88|0.41|0.009
91641136|NCT01945034|183173613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.22|0.52|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.52|0.22|< 0.001
91641137|NCT01945034|183173615|SUPERIORITY_OR_OTHER|||||||0.479|||||||Cochran-Mantel-Haenszel|p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.||||||0.479
91485801|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.053
91641138|NCT01945034|183173615|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.279
91641139|NCT01945034|183173615|SUPERIORITY_OR_OTHER|||||||0.129|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.129
91641140|NCT02277665|183173628|SUPERIORITY|Chi-square|Odds Ratio (OR)|0.56|||=|0.33|TWO_SIDED|95.0|0.17|1.82|||Chi-squared|||||1.82|.17|= 0.33
91641141|NCT02277665|183173629|OTHER||Odds Ratio (OR)|0.32||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
91641142|NCT02277665|183173630|OTHER||Odds Ratio (OR)|0.45|||=|0.16|TWO_SIDED|95.0|0.15|1.35|||Chi-squared|||||1.35|0.15|= 0.16
91641143|NCT02277665|183173631|SUPERIORITY||Means Ratio|0.97||||0.87|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.87
91641144|NCT02277665|183173632|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91641145|NCT02277665|183173633|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
91641146|NCT00463385|183173654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
91641147|NCT00463385|183173654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0|||||Fisher Exact|||||||0.048
91641148|NCT00463385|183173654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0|||||Fisher Exact|||||||0.758
91641149|NCT02354352|183173711|NON_INFERIORITY|Using a Type I error rate of 5%, we conducted a power calculation using a non-inferiority test on 12-month change in Ecc. If there is truly no difference in the 12-month Ecc change between the spironolactone and eplerenone groups, 46 patients (23 in each group) would result in at least 80% power to ensure that the lower limit of a one-sided 95% confidence interval for the true difference between the spironolactone and eplerenone groups to be above the non-inferiority limit of -1.75.||||||0.5867|||||||Wilcoxon (Mann-Whitney)|||||||0.5867
91674536|NCT02287909|183242787|SUPERIORITY||least square mean difference|-6.9|||>|0.05|TWO_SIDED|985.0|-38.0|24.0|||ANCOVA|||||24|-38|>0.05
91674537|NCT02130583|183242860|SUPERIORITY||Mean Difference (Net)|2.06||||0.034|TWO_SIDED||||||ANOVA|||||||.034
91674538|NCT03702049|183242889|OTHER|Change in score at 3 months|Mean Difference (Final Values)|-0.24||||0.603|TWO_SIDED||||||Mixed Models Analysis|||Change in score at 3 months||||0.603
91674539|NCT03702049|183242889|OTHER|Change at 6 months|Mean Difference (Final Values)|-0.12||||0.805|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.805
91674540|NCT03702049|183242890|OTHER||Odds Ratio (OR)|0.83||||0.672|TWO_SIDED|95.0|0.39|1.79|||Regression, Logistic|||3 month outcome||1.79|0.39|0.672
91485802|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.061
91674541|NCT03702049|183242890|OTHER||Odds Ratio (OR)|0.49||||0.165|TWO_SIDED|95.0|0.18|1.34|||Regression, Logistic|||6 month outcome||1.34|0.18|0.165
91674542|NCT03702049|183242891|OTHER||Mean Difference (Final Values)|-0.31||||0.719|TWO_SIDED||||||Mixed Models Analysis|||3 month outcome||||0.719
91674543|NCT03702049|183242891|OTHER||Mean Difference (Final Values)|0.43||||0.626|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.626
91674544|NCT03702049|183242892|OTHER||Mean Difference (Final Values)|0.83||||0.1668|TWO_SIDED|95.0|-0.36|2.03|||t-test, 2 sided|||||2.03|-0.36|0.1668
91674545|NCT03702049|183242893|OTHER||Mean Difference (Final Values)|1.5||||0.9198|TWO_SIDED|95.0|-29.6|32.7|||t-test, 2 sided|||3 month outcome||32.7|-29.6|0.9198
91674546|NCT03702049|183242893|OTHER||Mean Difference (Final Values)|12.5||||0.5015|TWO_SIDED|95.0|-25.6|50.7|||t-test, 2 sided|||6 month||50.7|-25.6|0.5015
91674547|NCT03438396|183242898|OTHER|The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.||||||0.0002|||||||one-sided exact test|||||||0.0002
91674548|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
91485803|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
91674549|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
91674550|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||<0.001
91674551|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.003||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||0.003
91674552|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||<0.001
91674553|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.071||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||0.071
91674554|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
91674555|NCT00262041|183242911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
91674556|NCT03028740|183242916|SUPERIORITY||Percentage Difference|-3.2||||0.2067|TWO_SIDED|95.0|-8.2|1.9||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).|Cochran-Mantel-Haenszel|||||1.9|-8.2|0.2067
91674557|NCT03028740|183242916|SUPERIORITY||Odds Ratio (OR)|0.8369|||||TWO_SIDED|95.0|0.6341|1.1044|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1044|0.6341|
91674558|NCT03028740|183242918|SUPERIORITY||Percentage Difference|-1.7||||0.2827|TWO_SIDED|95.0|-4.8|1.5||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||1.5|-4.8|0.2827
91674559|NCT03028740|183242918|SUPERIORITY||Odds Ratio (OR)|0.7844|||||TWO_SIDED|95.0|0.5032|1.2229|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.2229|0.5032|
91674560|NCT03028740|183242919|SUPERIORITY||Percentage Difference|-2.7||||0.4054|TWO_SIDED|95.0|-8.7|3.3||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||3.3|-8.7|0.4054
91674561|NCT03028740|183242919|SUPERIORITY||Odds Ratio (OR)|0.8877|||||TWO_SIDED|95.0|0.6709|1.1744|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1744|0.6709|
91674562|NCT01138826|183242940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|105.57|||||TWO_SIDED|90.0|98.09|113.61||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||113.61|98.09|
91674563|NCT01138826|183242940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|107.55|||||TWO_SIDED|90.0|99.98|115.69||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||115.69|99.98|
91674564|NCT01138826|183242940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|101.88|||||TWO_SIDED|90.0|94.7|109.6||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||109.60|94.70|
91674565|NCT01138826|183242941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|103.88|||||TWO_SIDED|90.0|97.27|110.94||||||||110.94|97.27|
91716788|NCT04233879|183325413|SUPERIORITY|Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0.|Treatment Difference|0.15||||0.73|TWO_SIDED|95.0|-0.71|1.02|||ANCOVA|A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.|ANCOVA model was used to generate treatment difference and the associated 95%CI.|||1.02|-0.71|0.73
91716789|NCT03585270|183325424|SUPERIORITY||Relative Risk Reduction|0.072||||0.7338|TWO_SIDED|95.0|-0.426|0.396|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.2785).|||0.396|-0.426|0.7338
91716790|NCT03585270|183325425|SUPERIORITY||Relative Risk Reduction|0.341||||0.177|TWO_SIDED|95.0|-0.213|0.642|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8644).|||0.642|-0.213|0.177
91716791|NCT03585270|183325426|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
91527865|NCT06173570|182930696|SUPERIORITY||Mean Difference (Net)|-0.93||||0.634|TWO_SIDED|95.0|-4.74|2.89|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||2.89|-4.74|0.634
91716792|NCT03585270|183325427|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
91716793|NCT03585270|183325428|SUPERIORITY||Relative Risk Reduction|0.119||||0.5591|TWO_SIDED|95.0|-0.349|0.425|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1706).|||0.425|-0.349|0.5591
91716794|NCT03585270|183325429|SUPERIORITY||Relative Risk Reduction|0.267||||0.1179|TWO_SIDED|95.0|-0.085|0.505|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.4580)|||0.505|-0.085|0.1179
91716795|NCT03585270|183325430|SUPERIORITY||Relative Risk Reduction|0.139||||0.5217|TWO_SIDED|95.0|-0.365|0.457|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1685)|||0.457|-0.365|0.5217
91674566|NCT01138826|183242941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|104.26|||||TWO_SIDED|90.0|97.67|111.3||||||||111.30|97.67|
91674567|NCT01138826|183242941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|100.37|||||TWO_SIDED|90.0|94.02|107.15||||||||107.15|94.02|
91793257|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence||||||0.002||||||This is the p value of the null hypothesis that COST estimates for all cancer types (Colon cancer, Rectal cancer and Rectosigmoid) are equal against the alternative that at least one is different.|Regression, Linear|||"Cancer type (Colon cancer, Rectal cancer and Rectosigmoid) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.002
91793258|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence|Slope|0.3||||0.03|TWO_SIDED|95.0|0.0|0.6|||Regression, Linear|||"FACT-G7 effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.6|0.0|0.03
91793259|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence|Slope|1.6||||0.13|TWO_SIDED|95.0|-0.5|3.7|||Regression, Linear|||"Gender effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||3.7|-0.5|0.13
91793260|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence||||||0.91||||||This is the p value of the null hypothesis that COST estimates for all RACES (White, Black, other) are equal against the alternative that at least one is different.|Regression, Linear|||"RACE (White. Black Other) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.91
91793261|NCT03516942|183464330|EQUIVALENCE|No margin of equivalence|Slope|0.0|||>|0.99|TWO_SIDED|95.0|-0.3|0.3|||Regression, Linear|||"Neighborhood Deprivation (NDI) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Higher NDI = greater neighborhood deprivation"||0.3|-0.3|>0.99
91485804|NCT00785928|182844677|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.030
91526531|NCT02265224|182928213|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|89.81||||0.0136|TWO_SIDED|94.12|82.82|97.4||p value for treatment effect|ANOVA|||||97.40|82.82|0.0136
91641150|NCT04436497|183173791|SUPERIORITY||Disease Rate Ratio|1.08|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.874|1.307||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. zilucoplan slowed progression) was 0.2418. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by zilucoplan relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.307|0.874|
91716796|NCT02756910|183325440|OTHER||percentile method|0.5|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|||||bootstrapping|||||||<0.05
91716797|NCT00323063|183325441|OTHER|||||||0.3|||||||Log Rank|||||||0.3
91793262|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.4142||||||alpha=0.05|McNemar|||Work Time Missed from Baseline to 6 Months||||0.4142
91485805|NCT05027464|182844680|SUPERIORITY||Odds Ratio (OR)|1.249||||0.202|TWO_SIDED|95.0|0.888|1.759||Not adjusted for multiple comparisons; a priori threshold was P \< 0.05.|Regression, Logistic|Patient demographics were fixed effects, and randomization units with clinics nested within randomization units were random effects.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Generalized linear mixed model to account for patient demographics and hierarchical levels for clinics nested within VAHCS. Null hypothesis is that both arms perform equivalently in vaccine uptake after a year. Power was based on recruited VAHCSs and at least 1,000 Veterans per clinic. Using two-sided 0.05 type I error rate, 5-20% outcome rate in UC, we have 90% power to detect between a 9.6% and 14.6% difference with a total sample size of 90,000 to 100,000.||1.759|0.888|0.202
91793263|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.1797|||||||McNemar|||Impairment of Activities at Work from Baseline to 6 Months||||0.1797
91793264|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.8415|||||||McNemar|||Overall Work Impairment from Baseline to 6 Months||||0.8415
91793265|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.6831|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 6 Months||||0.6831
91793266|NCT03516942|183464332|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Work Time Missed from Baseline to 12 Months||||<.0001
91793267|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.0455|||||||McNemar|||Impairment of Activities at Work from Baseline to 12 Months||||0.0455
91793268|NCT03516942|183464332|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 12 Months||||<.0001
91793269|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.0164|||||||McNemar|||3 Impairment of Activities Outside of Work from Baseline to 12 Months||||0.0164
91793270|NCT03516942|183464332|EQUIVALENCE|nomargin||||||0.0027|||||||McNemar|||Work Time Missed from Baseline to 24 Months||||0.0027
91485806|NCT05027464|182844680|SUPERIORITY||Odds Ratio (OR)|1.228||||0.247|TWO_SIDED|95.0|0.867|1.738|||Regression, Logistic|||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.738|0.867|0.247
91485807|NCT05027464|182844680|SUPERIORITY||Odds Ratio (OR)|1.263||||0.455|TWO_SIDED|95.0|0.684|2.334|||Regression, Logistic|||Sensitivity analysis; same model and null hypothesis but reassigning small clinics to their parent VAHCS facility, small meaning \< 100 participants. This data set uses the primary analysis data set with the primary visit constraint.||2.334|0.684|0.455
91641151|NCT04436497|183173793|SUPERIORITY||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|1.819||0.5495|TWO_SIDED|95.0|-4.66|2.48|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||2.48|-4.66|0.5495
91641152|NCT04436497|183173794|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|3.409||0.7602|TWO_SIDED|95.0|-7.73|5.65|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||5.65|-7.73|0.7602
91526532|NCT02265224|182928214|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|90.79||||0.0047|TWO_SIDED|94.12|85.25|96.69|||ANOVA|p value for treatment effect||||96.69|85.25|0.0047
91641153|NCT04436497|183173795|SUPERIORITY|||||||0.6891|||||||Log Rank|||||||0.6891
91641154|NCT01335620|183173799|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||Compare baseline to 24 weeks||||0.018
91641155|NCT00585468|183173807|SUPERIORITY_OR_OTHER|||||||0.0163|||||||t-test, 2 sided|||||||0.0163
91641156|NCT00585468|183173808|SUPERIORITY_OR_OTHER|||||||0.039|||||||t-test, 2 sided|||||||0.039
91641157|NCT00585468|183173810|SUPERIORITY_OR_OTHER|||||||0.146|||||||t-test, 2 sided|||||||0.146
91641158|NCT00585468|183173811|SUPERIORITY_OR_OTHER|||||||0.4937|||||||t-test, 2 sided|||||||0.4937
91641159|NCT00585468|183173812|SUPERIORITY_OR_OTHER|||||||0.9669|||||||t-test, 2 sided|||||||0.9669
91641160|NCT00585468|183173814|SUPERIORITY_OR_OTHER|||||||0.9607|||||||t-test, 2 sided|||||||0.9607
91716798|NCT03904693|183325444|SUPERIORITY||Geometric Mean Ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||ANCOVA|||||0.82|0.61|<0.0001
91485808|NCT05027464|182844680|SUPERIORITY||Odds Ratio (OR)|1.26||||0.364|TWO_SIDED|95.0|0.765|2.075|||Regression, Logistic|||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||2.075|0.765|0.364
91641161|NCT00978120|183173816|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
91641162|NCT00978120|183173817|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
91641163|NCT00978120|183173820|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.470
91641164|NCT00978120|183173821|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||||||0.120
91641165|NCT00978120|183173822|SUPERIORITY_OR_OTHER|||||||0.284|||||||Fisher Exact|||||||0.284
91641166|NCT00978120|183173823|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
91641167|NCT00978120|183173824|SUPERIORITY_OR_OTHER|||||||0.341|||||||Fisher Exact|||||||0.341
91641168|NCT00978120|183173825|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.020
91641169|NCT00978120|183173826|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||||||0.245
91641170|NCT00978120|183173827|SUPERIORITY_OR_OTHER|||||||0.173|||||||Fisher Exact|||||||0.173
91641171|NCT00978120|183173828|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||||||0.362
91641172|NCT00978120|183173829|SUPERIORITY_OR_OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
91641173|NCT00978120|183173830|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher Exact|||||||0.016
91641174|NCT00978120|183173831|SUPERIORITY_OR_OTHER|||||||0.032|||||||Fisher Exact|||||||0.032
91641175|NCT01298323|183173848|SUPERIORITY_OR_OTHER_LEGACY||t-Statistic|1.29||||0.199|TWO_SIDED|95.0|-3.44|16.37||Statistical significance threshold at this analysis was 10%|t-test, 2 sided|||||16.37|-3.44|0.199
91641176|NCT03655951|183173864|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
91641177|NCT03655951|183173865|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
91641178|NCT03655951|183173866|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
91641179|NCT03655951|183173867|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
91641180|NCT03655951|183173868|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
91641181|NCT03655951|183173869|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
91641182|NCT03655951|183173870|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.87|||||||Regression, Linear|||||||.87
91716799|NCT03904693|183325444|SUPERIORITY||Geometric Mean Ratio|0.72|||<|0.0001|TWO_SIDED|95.0|0.64|0.8|||ANCOVA|||||0.80|0.64|<0.0001
91485809|NCT05027464|182844680|SUPERIORITY||Odds Ratio (OR)|1.268||||0.168|TWO_SIDED|95.0|0.904|1.778|||Regression, Logistic|||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.778|0.904|0.168
91716800|NCT03904693|183325445|SUPERIORITY||Geometric Mean Ratio|16.04|||=|0.3802|TWO_SIDED|95.0|-17.0|49.08|||ANCOVA|||||49.08|-17.0|=0.3802
91716801|NCT03904693|183325445|SUPERIORITY||Geometric Mean Ratio|25.37|||=|0.0591|TWO_SIDED|95.0|-0.93|51.59|||ANCOVA|||||51.59|-0.93|=0.0591
91641183|NCT03655951|183173871|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.8|||||||Regression, Linear|||||||.8
91641184|NCT03655951|183173872|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.32|||||||Regression, Linear|||||||.32
91641185|NCT03655951|183173873|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
91641186|NCT03655951|183173874|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
91641187|NCT03655951|183173875|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
91641188|NCT03655951|183173876|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.42|||||||Regression, Linear|||||||.42
91641189|NCT03655951|183173877|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
91641190|NCT03655951|183173878|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0003|||||||Regression, Linear|||||||.0003
91641191|NCT03655951|183173879|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.97|||||||Regression, Linear|||||||.97
91641192|NCT03655951|183173880|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.08|||||||Regression, Linear|||||||.08
91641193|NCT03655951|183173881|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.7|||||||Regression, Linear|||||||.70
91641194|NCT03655951|183173882|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
91641195|NCT03655951|183173883|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
91641196|NCT03655951|183173884|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
91641197|NCT03655951|183173885|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.61|||||||Regression, Linear|||||||.61
91641198|NCT03655951|183173886|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.72|||||||Regression, Linear|||||||.72
91641199|NCT03655951|183173887|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
91641200|NCT03655951|183173888|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
91641201|NCT03655951|183173889|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
91641202|NCT03655951|183173890|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
91641203|NCT03655951|183173891|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
91485810|NCT05027464|182844681|SUPERIORITY||Odds Ratio (OR)|0.993||||0.976|TWO_SIDED|95.0|0.643|1.535||P \< 0.05 and no multiple comparison adjustment|Regression, Logistic|We adjusted for patient demographics as fixed effects and randomization units and associated clinics as a three-level random effect.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Power calculation is similar to the calculation for the primary outcome. Null hypothesis is described in the outcome comparison related to this statistical analysis plan.||1.535|0.643|.976
91641204|NCT03655951|183173892|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
91641205|NCT03655951|183173893|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0001|||||||Regression, Linear|||||||.0001
91716802|NCT02240667|183325477|OTHER|||||||0.8496|||||||stratified log-rank test|||Persistence in both treatment groups was compared by means of the stratified Log-rank test||||0.8496
91641206|NCT03655951|183173894|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
91641207|NCT03655951|183173895|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
91641208|NCT03655951|183173896|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.62|||||||Regression, Linear|||||||.62
91641209|NCT03655951|183173897|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
91641210|NCT03655951|183173898|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.14|||||||Regression, Linear|||||||.14
91641211|NCT03655951|183173899|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.008|||||||Regression, Linear|||||||.008
91641212|NCT03655951|183173900|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
91641213|NCT03655951|183173901|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
91716803|NCT01076543|183325498|OTHER||Maximum tolerated dose in mg|20.0|||||TWO_SIDED||||||||"The maximum tolerated dose (MTD) was determined using the traditional 3+3 design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity."|||||
91716804|NCT01076543|183325500|SUPERIORITY||||||>|0.1|||||||Binomial exact test|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||>0.10
91641214|NCT03655951|183173902|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
91641215|NCT03655951|183173903|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.4|||||||Regression, Logistic|||||||.4
91641216|NCT03655951|183173904|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.02|||||||Regression, Logistic|||||||.02
91641217|NCT03655951|183173905|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
91641218|NCT03655951|183173906|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.31|||||||Regression, Linear|||||||.31
91641219|NCT03655951|183173907|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
91641220|NCT03655951|183173908|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.89|||||||Regression, Linear|||||||.89
91641221|NCT03655951|183173909|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
91641222|NCT03655951|183173910|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.93|||||||Regression, Linear|||||||.93
91641223|NCT03655951|183173911|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
91716805|NCT01076543|183325500|SUPERIORITY|||||||||||||||||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 50% vs. 70% alternative.|The follicular subgroup did not reach its accrual goal and was closed.|||
91674568|NCT01138826|183242942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|98.39|||||TWO_SIDED|90.0|91.05|106.33||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||106.33|91.05|
91674569|NCT01138826|183242942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|95.22|||||TWO_SIDED|90.0|88.16|102.84||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||102.84|88.16|
91674570|NCT01138826|183242942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|96.77|||||TWO_SIDED|90.0|89.58|104.54||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||104.54|89.58|
91674571|NCT02566993|183242945|SUPERIORITY||Hazard Ratio (HR)|0.967||||0.9029|TWO_SIDED|95.0|0.815|1.148|||Log Rank|Stratified log-rank test||||1.148|0.815|0.9029
91674572|NCT02566993|183242946|SUPERIORITY|||||||0.2826|||||||Normal test|||||||0.2826
91674573|NCT02566993|183242947|SUPERIORITY|||||||0.6216|||||||Normal test|||||||0.6216
91674574|NCT02566993|183242948|SUPERIORITY|||||||0.9708|||||||Normal test|||||||0.9708
91793271|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.0124|||||||McNemar|||Impairment of Activities at Work from Baseline to 24 Months||||0.0124
91793272|NCT03516942|183464332|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 24 Months||||<.0001
91793273|NCT03516942|183464332|EQUIVALENCE|no margin||||||0.0011|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 24 Months||||0.0011
91793274|NCT03516942|183464338|EQUIVALENCE|no equivalence margin was assumed||||||0.017|||||||McNemar|||the McNemar test was used to compare the results assuming a null of no difference.||||0.017
91674575|NCT02566993|183242949|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.3257|TWO_SIDED|95.0|0.693|0.996|||Log Rank|Stratified log-rank test||||0.996|0.693|0.3257
91674576|NCT02566993|183242950|SUPERIORITY|||||||0.0851|||||||Normal test|||||||0.0851
91674577|NCT02566993|183242951|SUPERIORITY|||||||0.0129|||||||Normal test|||||||0.0129
91674578|NCT02566993|183242953|SUPERIORITY|||||||0.6616|||||||Binomial test|||||||0.6616
91674579|NCT02566993|183242954|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.0012|TWO_SIDED|95.0|0.416|0.812|||Log Rank|||||0.812|0.416|0.0012
91793275|NCT07165366|183464343|SUPERIORITY||F-statistic|1.48||||0.231|TWO_SIDED|||||a priori threshold for significance was alpha=0.05|ANOVA|degrees of freedom for ANOVA F-statistic were 2 for numerator d.f. and 118 denominator d.f.||Null Hypothesis is that there will be no difference in enamel hardness when different concentrations are used on enamel surfaces.||||0.231
91674580|NCT02566993|183242955|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.744|1.14||||||||1.140|0.744|
91674581|NCT02566993|183242956|SUPERIORITY||Hazard Ratio (HR)|0.688|||||TWO_SIDED|95.0|0.549|0.863||||||||0.863|0.549|
91674582|NCT02566993|183242958|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.616|1.376||||||||1.376|0.616|
91674583|NCT02566993|183242959|SUPERIORITY||Hazard Ratio (HR)|0.504|||||TWO_SIDED|95.0|0.346|0.736||||||||0.736|0.346|
91674584|NCT02566993|183242960|SUPERIORITY||Hazard Ratio (HR)|1.122|||||TWO_SIDED|95.0|0.84|1.5||||||||1.500|0.840|
91674585|NCT02566993|183242961|SUPERIORITY||Hazard Ratio (HR)|1.306|||||TWO_SIDED|95.0|0.955|1.786||||||||1.786|0.955|
91674586|NCT02566993|183242963|SUPERIORITY||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.455|1.843||||||||1.843|0.455|
91674587|NCT02566993|183242964|SUPERIORITY||Hazard Ratio (HR)|1.092|||||TWO_SIDED|95.0|0.506|2.36||||||||2.360|0.506|
91674588|NCT02566993|183242965|SUPERIORITY||Hazard Ratio (HR)|0.923|||||TWO_SIDED|95.0|0.765|1.113||||||||1.113|0.765|
91674589|NCT02566993|183242966|SUPERIORITY||Hazard Ratio (HR)|0.788|||||TWO_SIDED|95.0|0.645|0.961||||||||0.961|0.645|
91674590|NCT02566993|183242968|SUPERIORITY||Hazard Ratio (HR)|0.903|||||TWO_SIDED|95.0|0.624|1.307||||||||1.307|0.624|
91674591|NCT02566993|183242969|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.392|0.799||||||||0.799|0.392|
91674592|NCT02566993|183242970|SUPERIORITY||Hazard Ratio (HR)|1.291|||||TWO_SIDED|95.0|0.838|1.99||||||||1.990|0.838|
91674593|NCT02566993|183242971|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.824|2.019||||||||2.019|0.824|
91674594|NCT02566993|183242973|SUPERIORITY||Hazard Ratio (HR)|1.032|||||TWO_SIDED|95.0|0.403|2.641||||||||2.641|0.403|
91674595|NCT02566993|183242974|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.373|2.75||||||||2.750|0.373|
91692159|NCT03296527|183279342|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-1.6|9.5|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of implanted embryos 5-6 weeks after transfer||9.5|-1.6|
91692160|NCT03296527|183279343|OTHER||Risk Difference (RD)|4.4|||||TWO_SIDED|95.0|-0.9|9.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing implantation rate||9.7|-0.9|
91692161|NCT03296527|183279344|SUPERIORITY|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.79||||0.083|TWO_SIDED|95.0|0.6|1.03||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=15 oocytes retrieved||1.03|0.60|0.083
91716806|NCT01076543|183325500|SUPERIORITY||||||<|0.1|||||||Binomial exact test.|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||<0.10
91716807|NCT00791999|183325539|SUPERIORITY_OR_OTHER||||||<|0.025||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.||||<0.025
91716808|NCT00791999|183325540|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||||||<0.05
91716809|NCT00737048|183325605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_DEVIATION|8.06|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 1 for Total pain relief based on numerical rating scale score||||<0.0001
91716810|NCT00737048|183325605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_DEVIATION|7.99|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 2 for Total pain relief based on numerical rating scale score||||<0.0001
91716811|NCT03845894|183325668|NON_INFERIORITY|There have been no studies to evaluate pain scores ISB w/ plain bupi+adjuvants. Power to detect difference at least 0.4 on the VAS scale. Threshold for inferiority is difference \>=2 points on the VAS scale. Will use two-sample t test with α= 0.05 and β= 0.1. Postop opioid consumption, total post-op opioid @ 1st 48 hours in oxycodone equivalents. Mean opioid consumption per cohort is calculated, \& the cohorts compared for statistical difference with two-sample t test, with α= 0.05 and β= 0.1.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91716812|NCT00879190|183325671|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91485811|NCT05027464|182844681|SUPERIORITY||Odds Ratio (OR)|0.978||||0.893|TWO_SIDED|95.0|0.702|1.361|||Regression, Logistic|GLMM||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.361|0.702|0.893
91716813|NCT00879190|183325672|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
91527866|NCT06173570|182930696|SUPERIORITY||Mean Difference (Net)|-0.02||||0.99|TWO_SIDED|95.0|-3.74|3.7|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||3.70|-3.74|0.990
91716814|NCT00879190|183325673|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||0.6
91716815|NCT00289211|183325682|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.048||||0.048||95.0|1.008|4.164|||Regression, Cox|||Subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations. Entries of 4.0 (hours) for median time to event or 95% CI indicate that data were NE (see Population Description). As non-numeric data are not supported by the median and 95% CI fields, entry of the actual results (ie, NE or \>4.0) was not possible.||4.164|1.008|0.048
91485812|NCT05027464|182844681|SUPERIORITY||Odds Ratio (OR)|0.961||||0.863|TWO_SIDED|95.0|0.613|1.507|||Regression, Logistic|GLMM||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||1.507|0.613|0.863
91716816|NCT00289211|183325683|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.41||||0.062||95.0|0.87|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.87|0.062
91716817|NCT00289211|183325684|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.717||||0.001||95.0|1.471|5.02|||Regression, Cox|||Subjects who had not experienced complete resolution of the HAE attack at the time of the follow-up telephone call, or who were lost to follow-up, were censored at 72 hours.||5.020|1.471|0.001
91716818|NCT00289211|183325685|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91716819|NCT00289211|183325685|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91716820|NCT00289211|183325685|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91716821|NCT00289211|183325685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0007
91716822|NCT00289211|183325686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91716823|NCT00289211|183325686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91716824|NCT00289211|183325686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91716825|NCT00289211|183325686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||95.0||||Percent change 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0022
91716826|NCT00289211|183325687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1321
91716827|NCT00289211|183325687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5218||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.5218
91716828|NCT00289211|183325687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.121||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1210
91716829|NCT00289211|183325687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0017
91716830|NCT03863353|183325706|SUPERIORITY||Rebression coefficient|2.13||||0.001|TWO_SIDED|95.0|0.86|3.4||Adjusted for repeated measures and effects of covariates|Regression, Linear|||Hypothesis was tested using multivariable regression models (generalized estimating equation)||3.40|0.86|.001
91674596|NCT02278718|183242997|SUPERIORITY|||||||0.0008|||||||Generalized Wilcoxon-Gehan Test|||Wilcoxon test statistic was estimated using generalized Wilcoxon-Gehan test stratified by center group, age group, % TBSA group, proportion of FT area group and number of TWs group. A negative (positive) statistic is associated with longer (shorter) time to the event when treated with NexoBrid vs. Standard of Care. P-value was calculated using the re-randomization test.||||0.0008
91526533|NCT02265224|182928215|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|91.86||||0.0095|TWO_SIDED|94.12|86.45|97.61||p value for treatment effect|ANOVA|||||97.61|86.45|0.0095
91674597|NCT02278718|183242998|SUPERIORITY||Odds Ratio (OR)|0.025|||<|0.0001|TWO_SIDED|95.0|0.007|0.09|||Fisher Exact|||Incidence of Surgical Excision for Eschar Removal for NexoBrid vs SOC||0.090|0.007|<0.0001
91674598|NCT02278718|183242999|SUPERIORITY|||||||0.1374|||||||t-test, 2 sided|||||||0.1374
91674599|NCT02278718|183243000|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.5045|TWO_SIDED||||||t-test, 2 sided|||||||0.5045
91674600|NCT02278718|183243001|SUPERIORITY||Odds Ratio (OR)|0.414||||0.0545|TWO_SIDED|95.0|0.163|1.054|||t-test, 2 sided|||||1.054|0.163|0.0545
91674601|NCT04440449|183243002|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91674602|NCT04440449|183243003|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|||||||0.108
91674603|NCT03212794|183243011|SUPERIORITY||||||=|0.87||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.87
91716831|NCT03863353|183325707|SUPERIORITY||Odds Ratio (OR)|1.17||||0.534|TWO_SIDED|95.0|0.72|1.9||adjusted for covariates|Regression, Logistic|||Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)||1.90|0.72|0.534
91674604|NCT03212794|183243012|SUPERIORITY||||||=|0.82||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.82
91674605|NCT03212794|183243013|OTHER||||||=|0.92||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.92
91674606|NCT03212794|183243014|OTHER||||||=|0.85||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.85
91674607|NCT01763918|183243017|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.23|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-65.11|-53.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.35|-65.11|<0.001
91674608|NCT01763918|183243017|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.27|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-69.0|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.55|-69.00|<0.001
91674609|NCT01763918|183243018|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.15|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-65.83|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-65.83|<0.001
91674610|NCT01763918|183243018|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.55|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-71.27|-59.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.83|-71.27|<0.001
91674611|NCT01763918|183243019|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-95.2|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-105.1|-85.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-85.2|-105.1|<0.001
91674612|NCT01763918|183243019|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-97.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-107.1|-87.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-87.7|-107.1|<0.001
91674613|NCT01763918|183243020|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-92.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-102.9|-82.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-82.8|-102.9|<0.001
91692162|NCT03296527|183279344|OTHER|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.89||||0.489|TWO_SIDED|95.0|0.65|1.23||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=20 oocytes retrieved||1.23|0.65|0.489
91485813|NCT05027464|182844681|SUPERIORITY||Odds Ratio (OR)|1.011||||0.963|TWO_SIDED|95.0|0.636|1.607|||Regression, Logistic|GLMM||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.607|0.636|0.963
91485814|NCT05027464|182844682|SUPERIORITY||Odds Ratio (OR)|1.191||||0.395|TWO_SIDED|95.0|0.796|1.781||Threshold: P \< 0.05; not adjusted for multiple comparisons|Regression, Logistic|Generalized linear mixed modeling adjusted for baseline covariates and hierarchical levels for randomization units and clinics within them.|Odds ratio in favor of intervention arm (MI) has values higher than 1.|No power calculation for this exploratory outcome. Null hypothesis is that both arms will have equal uptake rates of the COVID-19 Booster vaccination during the study period.||1.781|0.796|0.395
91485815|NCT05027464|182844683|SUPERIORITY||Odds Ratio (OR)|1.128||||0.119|TWO_SIDED|95.0|0.97|1.311||P-value was not adjusted for multiple comparisons and the p-value threshold was \< 0.05.|Regression, Logistic|Generalized linear mixed model adjusting for baseline covariates and flu vaccine in prior year, with hierarchical random effects for ran. unit/site|Odds ratio in favor of novel intervention arm has values higher than 1|Null hypothesis is that both study arms will have equal rates of flu vaccination uptake during the study period. No power calculation since this outcome is exploratory.||1.311|0.97|0.119
91485816|NCT01539642|182844696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.02|STANDARD_ERROR_OF_MEAN|15.25||0.001|TWO_SIDED|95.0|19.89|80.14|||ANCOVA|||||80.14|19.89|0.001
91485817|NCT05021081|182844715|OTHER|The least-square means (i.e., adjusted means) of photopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.7|-0.21|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean photopic contrast sensitivity with and without the glare source.||-0.21|-0.70|
91641224|NCT03655951|183173912|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
91641225|NCT03655951|183173913|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.13|||||||Regression, Linear|||||||.13
91641226|NCT03655951|183173914|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.56|||||||Regression, Linear|||||||.56
91641227|NCT03655951|183173915|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.96|||||||Regression, Linear|||||||.96
91641228|NCT03655951|183173916|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.35|||||||Regression, Linear|||||||.35
91641229|NCT03655951|183173917|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.24|||||||Regression, Linear|||||||.24
91641230|NCT03655951|183173918|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.2
91641231|NCT03655951|183173919|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.18|||||||Regression, Linear|||||||.18
91641232|NCT03655951|183173920|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.67|||||||Regression, Linear|||To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||.67
91641233|NCT03655951|183173921|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
91641234|NCT03655951|183173922|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
91641235|NCT03655951|183173923|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.84|||||||Regression, Linear|||||||.84
91692163|NCT03296527|183279345|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.6||||0.075|TWO_SIDED|95.0|0.34|1.06||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade)||1.06|0.34|0.075
91641236|NCT03655951|183173924|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
91674614|NCT01763918|183243020|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-91.3|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-103.8|-78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-78.9|-103.8|<0.001
91674615|NCT01763918|183243021|SUPERIORITY_OR_OTHER||Treatment Difference|65.1|||<|0.001|TWO_SIDED|95.0|52.8|73.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||73.4|52.8|<0.001
91674616|NCT01763918|183243021|SUPERIORITY_OR_OTHER||Treatment Difference|78.5|||<|0.001|TWO_SIDED|95.0|66.9|85.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||85.1|66.9|<0.001
91674617|NCT01763918|183243022|SUPERIORITY_OR_OTHER||Treatment Difference|66.3|||<|0.001|TWO_SIDED|95.0|53.7|74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use||||74.6|53.7|<0.001
91674618|NCT01763918|183243022|SUPERIORITY_OR_OTHER||Treatment Difference|60.9|||<|0.001|TWO_SIDED|95.0|47.6|69.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||69.8|47.6|<0.001
91716832|NCT00966433|183325708|OTHER||Mean Difference (Final Values)|-8.2||||0.0051|TWO_SIDED|95.0|-13.61|-2.79|||t-test, 2 sided|||||-2.79|-13.61|.0051
91641237|NCT03655951|183173925|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
91641238|NCT03655951|183173926|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
91641239|NCT03655951|183173927|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
91641240|NCT03655951|183173928|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.47|||||||Regression, Linear|||||||.47
91641241|NCT03655951|183173929|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.003|||||||Regression, Linear|||||||.003
91641242|NCT03655951|183173930|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.77|||||||Regression, Linear|||||||.77
91641243|NCT03655951|183173931|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.|||||<|0.001|||||||Regression, Linear|||||||<.001
91641244|NCT03655951|183173932|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.06|||||||Regression, Linear|||||||.06
91641245|NCT03655951|183173933|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.91|||||||Regression, Linear|||||||.91
91641246|NCT03655951|183173934|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
91641247|NCT03655951|183173935|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.12|||||||Regression, Linear|||||||.12
91641248|NCT03655951|183173936|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
91641249|NCT03655951|183173937|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
91641250|NCT03655951|183173938|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
91641251|NCT03655951|183173939|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.07|||||||Regression, Linear|||||||.07
91641252|NCT03655951|183173940|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
91526534|NCT02265224|182928216|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.||||||0.505|||||||Friedman test|||||||0.5050
91526535|NCT00136812|182928224|OTHER|We used all available observations in a GEE analysis and did not impute missing data or drop observations.|Odds Ratio (OR)|3.15||||0.018|TWO_SIDED|95.0|1.22|8.14||P-value of \<0.05 is considered statistically significant.|generalized estimating equation model|||To test the primary hypothesis, we ran a generalized estimating equation model with logit link function (PROC GENMOD in SAS version 9.2), to examine abstinence versus smoking status at the 3- through 18-month follow-ups by condition.||8.14|1.22|0.018
91641253|NCT03655951|183173941|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.15|||||||Regression, Linear|||||||.15
91641254|NCT02486263|183173957|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was \<0.05.|Chi-squared|||||||0.28
91641255|NCT02486263|183173958|SUPERIORITY||Odds Ratio (OR)|0.8||||0.99|TWO_SIDED|95.0|0.4|1.6||Used Bonferroni adjustment for multiple comparisons. Threshold for statistical significance was p\<0.05|Generalized Estimation Equation||Data presented as OR (95% CI) using Generalized Estimation Equation (GEE) model with Conventional as reference.|Generalized Estimation Equation (GEE) model was used for the comparison of differences between intervention groups from week 0 to week 5 for peristaltic response frequency.||1.6|0.4|0.99
91641256|NCT02486263|183173959|SUPERIORITY|Weight velocity in grams/day||||||0.64|||||||t-test, 2 sided|||||||0.64
91674619|NCT01763918|183243023|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.0|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-61.41|-50.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.59|-61.41|<0.001
91674620|NCT01763918|183243023|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-65.24|-54.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.77|-65.24|<0.001
91674621|NCT01763918|183243024|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.79|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-60.47|-49.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-49.12|-60.47|<0.001
91674622|NCT01763918|183243024|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-61.95|-47.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.96|-61.95|<0.001
91674623|NCT01763918|183243025|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.39|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-54.32|-44.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.46|-54.32|<0.001
91674624|NCT01763918|183243025|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.58|-50.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.38|-59.58|<0.001
91716833|NCT00966433|183325709|OTHER||Mean Difference (Final Values)|3.6||||0.0001|TWO_SIDED|95.0|2.97|4.23|||t-test, 2 sided|||||4.23|2.97|.0001
91526536|NCT03349268|182928242|SUPERIORITY|||||||0.23|||||||Poisson regression|||||||0.23
91641257|NCT02486263|183173960|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
91641258|NCT02486263|183173961|SUPERIORITY|||||||0.49||||||Threshold for statistical significance \<0.05|Chi-squared|||||||0.49
91641259|NCT01361308|183173998|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
91674625|NCT01763918|183243026|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.09|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-54.55|-43.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.63|-54.55|<0.001
91674626|NCT01763918|183243026|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.41|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-55.73|-43.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.10|-55.73|<0.001
91716834|NCT00966433|183325714|OTHER||Mean Difference (Final Values)|-13.9||||0.0001|TWO_SIDED|95.0|-18.88|-8.92|||t-test, 2 sided|||||-8.92|-18.88|.0001
91716835|NCT04275336|183325832|OTHER||H value|1.344||||0.511|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.511
91641260|NCT01361308|183173998|SUPERIORITY_OR_OTHER|||||||0.009||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0090
91641261|NCT01361308|183173999|SUPERIORITY_OR_OTHER|||||||0.001||||||Clinical meaningfulness at week 4|Logit model|||||||0.001
91641262|NCT01361308|183173999|SUPERIORITY_OR_OTHER|||||||0.055||||||Clinical meaningfulness at week 12|Logit model|||||||0.055
91641263|NCT01361308|183174015|SUPERIORITY_OR_OTHER|||||||0.0017||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0017
91641264|NCT01361308|183174015|SUPERIORITY_OR_OTHER|||||||0.1658||||||Week 12 severity|Rank transformed ANCOVA|||||||0.1658
91485818|NCT05021081|182844716|OTHER|The least-square means (i.e., adjusted means) of mesopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|-0.81|-0.36|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean mesopic contrast sensitivity with and without the glare source.||-0.36|-0.81|
91526537|NCT00985543|182928247|NON_INFERIORITY_OR_EQUIVALENCE|Results are considered statistically significant at p\<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.|||||<|0.05|TWO_SIDED|90.0|||||maximum likelihood regression|||Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0-12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.||||<0.05
91526538|NCT00308737|182928291|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of TI + Usual Care to Usual Care only|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.014|0.06|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate||0.060|0.014|
91641265|NCT00066573|183174056|SUPERIORITY|To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.|Hazard Ratio (HR)|1.02||||0.85|TWO_SIDED|95.0|0.87|1.18|||Log Rank|||||1.18|0.87|0.85
91641266|NCT00066573|183174057|SUPERIORITY|No power calculation for secondary analysis|Hazard Ratio (HR)|0.93||||0.46|TWO_SIDED|95.0|0.77|1.13|||Log Rank|||||1.13|0.77|0.46
91641267|NCT01646268|183174064|SUPERIORITY_OR_OTHER||LS Means|-4.82|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-7.18|-2.45|||ANCOVA||Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.|The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).||-2.45|-7.18|<0.0001
91674627|NCT01763918|183243027|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.59|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-51.43|-41.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-41.76|-51.43|<0.001
91674628|NCT01763918|183243027|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.16|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-54.21|-44.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.11|-54.21|<0.001
91674629|NCT01763918|183243028|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.08|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-51.27|-40.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.88|-51.27|<0.001
91716836|NCT04275336|183325833|OTHER||H value|5.272||||0.072|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.072
91641268|NCT02222246|183174068|NON_INFERIORITY|Change in pain scores from arrival to discharge||||||0.0311|||||||Mixed Models Analysis|Analysis for pain change was conducted using Hierarchical Linear Mixed Effects Model (HLM), adjusting for nested patient and site effects (N=126)||||||0.0311
91641269|NCT02222246|183174069|NON_INFERIORITY|Trajectory of pain across time (arrival to discharge)||||||0.0049||||||p-value for the protocol by time interaction|Mixed Models Analysis|||The trajectory of change in pain score was evaluated every 30 minutes over 120 hours (2 hours) rather than 6 hours because of expected missing data after 120 minutes due to discharge from the ED.||||0.0049
91641270|NCT02222246|183174069|NON_INFERIORITY|Emergency Department Arrival||||||0.9393|||||||t-test, 2 sided|||||||0.9393
91674630|NCT01763918|183243028|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.42|STANDARD_ERROR_OF_MEAN|3.77|<|0.001|TWO_SIDED|95.0|-52.86|-37.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-37.98|-52.86|<0.001
91674631|NCT01763918|183243029|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.17|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-58.35|-47.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.99|-58.35|<0.001
91674632|NCT01763918|183243029|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.56|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-61.08|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.05|-61.08|<0.001
91674633|NCT01763918|183243030|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.28|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-60.16|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-48.41|-60.16|<0.001
91716837|NCT04275336|183325834|OTHER||H value|0.198||||0.906|ONE_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.906
91716838|NCT04275336|183325835|OTHER||H value|6.679||||0.035|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.035
91527867|NCT06173570|182930696|SUPERIORITY||Mean Difference (Net)|1.73||||0.366|TWO_SIDED|95.0|-2.03|5.5|||Mixed Models Analysis||Difference = AZD0780 - Placebo; positive values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||5.50|-2.03|0.366
91641271|NCT02222246|183174069|NON_INFERIORITY|Post-placement 30 minutes||||||0.7259|||||||t-test, 2 sided|||||||0.7259
91641272|NCT02222246|183174069|NON_INFERIORITY|Post-placement 60 minutes||||||0.53|||||||t-test, 2 sided|||||||0.5300
91641273|NCT02222246|183174069|NON_INFERIORITY|Post-placement 90 minutes||||||0.3678|||||||t-test, 2 sided|||||||0.3678
91641274|NCT02222246|183174069|NON_INFERIORITY|Post-placement 120 minutes||||||0.2457|||||||t-test, 2 sided|||||||0.2457
91641275|NCT02222246|183174069|NON_INFERIORITY|Emergency Department Discharge||||||0.0007|||||||t-test, 2 sided|||||||0.0007
91641276|NCT02222246|183174070|NON_INFERIORITY|Incidence of nausea during Emergency Department Visit - YES||||||0.0001|||||||Chi-squared|||||||0.0001
91641277|NCT02222246|183174071|NON_INFERIORITY|Incidence of vomiting (YES) during Emergency Department visit||||||0.6625|||||||Chi-squared|||||||0.6625
91641278|NCT02222246|183174072|NON_INFERIORITY|Decrease in systolic BP (\>= 20% of baseline)||||||0.4473|||||||Chi-squared|||||||0.4473
91641279|NCT02222246|183174073|NON_INFERIORITY|Decrease in diastolic blood pressure (\>= 20% baseline)||||||0.5372|||||||Chi-squared|||||||0.5372
91641280|NCT02222246|183174074|NON_INFERIORITY|Incidence of oxygen desaturation (\<95%) YES during Emergency Department visit||||||0.2891|||||||Chi-squared|||||||0.2891
91641281|NCT02222246|183174076|NON_INFERIORITY|Incidence of sedation during Emergency Department visit.||||||0.3915|||||||Chi-squared|||||||0.3915
91716839|NCT04275336|183325836|OTHER||Mean Difference (Final Values)|0.17||||0.844|TWO_SIDED|95.0||||\<0.05|ANOVA|||||||0.844
91716840|NCT04275336|183325837|OTHER||H value|1.651||||0.438|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.438
91641282|NCT02222246|183174077|NON_INFERIORITY|Incidence of the need for supplemental oxygen during Emergency Department visit||||||0.0726|||||||Chi-squared|||||||0.0726
91641283|NCT02544607|183174100|OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
91641284|NCT02544607|183174101|OTHER|||||||0.048|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.048
91641285|NCT02544607|183174102|OTHER|||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
91641286|NCT02544607|183174103|OTHER|||||||0.0499|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.0499
91641287|NCT02544607|183174104|OTHER|||||||0.038|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.038
91641288|NCT01969201|183174139|NON_INFERIORITY|The non-inferiority was evaluated by calculating the 95% CI for the differences in pregnancy rates between the two treatment groups. If the lower bound of the 95% CI of the difference between the two proportions was greater than -0.10 (i.e. 10%), then Fostimon was to be considered not inferior to the control treatment.|Mean Difference (Final Values)|-2.73||||0.49|TWO_SIDED|95.0|-9.88|4.42|||Fisher Exact|||||4.42|-9.88|0.49
91641289|NCT01969201|183174140|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91641290|NCT01969201|183174141|OTHER|||||||0.02|||||||ANOVA|||||||0.02
91641291|NCT01969201|183174142|OTHER|||||||0.32|||||||ANOVA|||||||0.32
91641292|NCT01969201|183174143|OTHER|||||||0.89|||||||ANOVA|||||||0.89
91641293|NCT01969201|183174144|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
91641294|NCT01969201|183174145|OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
91641295|NCT01969201|183174146|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
91641296|NCT01422876|183174150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.41|-0.75|<0.0001
91641297|NCT01422876|183174150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.32|-0.67|<0.0001
91641298|NCT01422876|183174150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.59|-0.25|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.25|-0.59|<0.0001
91641299|NCT01422876|183174150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.56|<0.0001
91641300|NCT01422876|183174151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.43|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-23.37|-9.48|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-9.48|-23.37|<0.0001
91641301|NCT01422876|183174151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.2|STANDARD_ERROR_OF_MEAN|3.62|<|0.0001|TWO_SIDED|95.0|-29.3|-15.1|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-15.10|-29.30|<0.0001
91641302|NCT01422876|183174151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.34|STANDARD_ERROR_OF_MEAN|3.55||0.0015|TWO_SIDED|95.0|-18.31|-4.37|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-4.37|-18.31|0.0015
91641303|NCT01422876|183174151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001|TWO_SIDED|95.0|-26.21|-12.03|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-12.03|-26.21|<0.0001
91716841|NCT04275336|183325838|OTHER||H value|0.341||||0.843|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.843
91716842|NCT04275336|183325839|OTHER||Median Difference (Final Values)|1.642||||0.44|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.440
91526539|NCT00308737|182928292|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the FEV1 change from Baseline for the TI group is no greater than 50 mL/year above the change in the usual care treatment group. Assuming SD of 100 mL/y, 80% power, and 5% (1-tailed) significance level, it was determined that 50 subjects were required for each of the diabetes treatment groups. Final sample size was selected for the incidence of a \>= 15% decrease in FEV1 end point.|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.016|0.057|||ANCOVA|||ANCOVA model with treatment site, diabetes type, and baseline FEV1||0.057|0.016|
91641304|NCT01422876|183174152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.31|STANDARD_ERROR_OF_MEAN|3.78||0.1605|TWO_SIDED|95.0|-12.74|2.11|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||2.11|-12.74|0.1605
91641305|NCT01422876|183174152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.82|STANDARD_ERROR_OF_MEAN|3.78||0.1246|TWO_SIDED|95.0|-13.25|1.61|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||1.61|-13.25|0.1246
91641306|NCT01422876|183174152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.63|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-31.06|-16.21|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-16.21|-31.06|<0.0001
91674634|NCT01763918|183243030|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-58.14|-40.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.96|-58.14|<0.001
91674635|NCT01763918|183243031|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.37|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-38.33|-24.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.41|-38.33|<0.001
91674636|NCT01763918|183243031|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-37.91|-24.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.09|-37.91|<0.001
91716843|NCT04664205|183325843|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
91526540|NCT00308737|182928293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|0.008|0.061|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FVC as a covariate||0.061|0.008|
91526541|NCT00308737|182928294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|||||TWO_SIDED|95.0|-0.042|0.031|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.031|-0.042|
91526542|NCT00308737|182928295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|||||TWO_SIDED|95.0|-0.037|0.574|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.574|-0.037|
91526543|NCT00308737|182928296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6475|||||TWO_SIDED|95.0|0.3432|1.2219|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.2219|0.3432|
91526544|NCT00308737|182928297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7504|||||TWO_SIDED|95.0|0.251|2.2431|||Regression, Logistic|||Logistic regression excluding non-diabetics||2.2431|0.2510|
91526545|NCT00308737|182928298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8953|||||TWO_SIDED|95.0|0.6703|1.1958|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.1958|0.6703|
91526546|NCT00308737|182928299|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.8509|||||TWO_SIDED|95.0|0.6722|1.077|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.0770|0.6722|
91526547|NCT00308737|182928301|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|||Two sample t-test||||0.112
91527868|NCT06173570|182930697|SUPERIORITY||Mean Difference (Net)|-25.79|||<|0.001|TWO_SIDED|95.0|-32.08|-19.51|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-19.51|-32.08|<0.001
91641307|NCT01422876|183174152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.29|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001|TWO_SIDED|95.0|-29.71|-14.88|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-14.88|-29.71|<0.0001
91674637|NCT01763918|183243032|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-39.28|-23.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.87|-39.28|<0.001
91716844|NCT04664205|183325844|SUPERIORITY|||||||0.069|||||||ANCOVA|||||||0.069
91716845|NCT04664205|183325845|SUPERIORITY|||||||0.478|||||||ANOVA|||||||0.478
91641308|NCT01422876|183174153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.43||0.6604|TWO_SIDED|95.0|-0.65|1.03||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||1.03|-0.65|0.6604
91641309|NCT01422876|183174153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.44|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.44|-3.15|<0.0001
91641310|NCT01422876|183174153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.43||0.8757|TWO_SIDED|95.0|-0.91|0.77||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||0.77|-0.91|0.8757
91641311|NCT01422876|183174153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.91|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.77|-1.05|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.05|-2.77|<0.0001
91641312|NCT01422876|183174154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.1785|TWO_SIDED|95.0|-0.33|0.06|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||0.06|-0.33|0.1785
91641313|NCT01422876|183174154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.61|<0.0001
91641314|NCT01422876|183174154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||Cochran-Mantel-Haenszel|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.22|-0.61|<0.0001
91674638|NCT01763918|183243032|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.24|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-35.61|-20.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-20.88|-35.61|<0.001
91674639|NCT01763918|183243033|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-29.48|-15.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.24|-29.48|<0.001
91641315|NCT01422876|183174154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.76|-0.37|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.37|-0.76|<0.0001
91674640|NCT01763918|183243033|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.74|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-24.43|-9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-9.05|-24.43|<0.001
91716846|NCT01578772|183325847|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.1|0.1|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||0.1|-0.1|<0.05
91716847|NCT01578772|183325848|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.7|||<|0.05|TWO_SIDED|95.0|-1.3|1.9|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||1.9|-1.3|<0.05
91526548|NCT00308737|182928302|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the difference in incidence of a decrease of ≥ 15% in FEV1 between the treatment groups not be greater than 5% for TI when compared with the usual care treatment group. Assuming an incidence rate of 15% for FEV1 and a noninferiority criterion of a 5% difference in incidence between the treatment groups, approximately 625 subjects per group were required for 80% power and an alpha of 5% (1 tailed).|Odds Ratio (OR)|-2.4767|||||TWO_SIDED|95.0|-4.5578|-0.3956|||Regression, Logistic|||Logistic regression excluding non-diabetics||-0.3956|-4.5578|
91641316|NCT01422876|183174155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.801|TWO_SIDED|95.0|-0.88|1.14||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||1.14|-0.88|0.8010
91641317|NCT01422876|183174155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.3616|TWO_SIDED|95.0|-1.48|0.54||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||0.54|-1.48|0.3616
91641318|NCT01422876|183174155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.51||0.0178|TWO_SIDED|95.0|-2.23|-0.21|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.21|-2.23|0.0178
91641319|NCT01422876|183174155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-2.97|-0.95|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.95|-2.97|0.0001
91641320|NCT01422876|183174156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.191|||<|0.0001|TWO_SIDED|95.0|2.319|7.573|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.573|2.319|<0.0001
91674641|NCT01763918|183243034|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.59|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|-27.92|-11.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-11.26|-27.92|<0.001
91641321|NCT01422876|183174156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.474|8.184|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||8.184|2.474|<0.0001
91641322|NCT01422876|183174156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.495|||<|0.0001|TWO_SIDED|95.0|1.92|6.363|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||6.363|1.920|<0.0001
91641323|NCT01422876|183174156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.795||||0.0005|TWO_SIDED|95.0|1.562|5.001|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.001|1.562|0.0005
91641324|NCT01422876|183174157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.893||||0.0224|TWO_SIDED|95.0|1.095|3.274|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||3.274|1.095|0.0224
91641325|NCT01422876|183174157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.961||||0.0001|TWO_SIDED|95.0|1.697|5.169|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.169|1.697|0.0001
91641326|NCT01422876|183174157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.065|||<|0.0001|TWO_SIDED|95.0|1.768|5.314|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.314|1.768|<0.0001
91641327|NCT01422876|183174157|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.303|||<|0.0001|TWO_SIDED|95.0|2.462|7.522|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.522|2.462|<0.0001
91641328|NCT01491737|183174181|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.007|TWO_SIDED|95.0|0.48|0.89||Test was performed at 2-sided alpha of 5%.|Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the PFS time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the PFS time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to PFS was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.89|0.48|0.0070
91641329|NCT01491737|183174181|OTHER|Exploratory|Hazard Ratio (HR)|0.67||||0.0059|TWO_SIDED|95.0|0.5|0.89|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis||0.89|0.50|0.0059
91641330|NCT01491737|183174182|OTHER|Exploratory|Hazard Ratio (HR)|1.15||||0.585|TWO_SIDED|95.0|0.69|1.91|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.91|0.69|0.5850
91641331|NCT01491737|183174182|OTHER|Exploratory|Hazard Ratio (HR)|1.05||||0.7833|TWO_SIDED|95.0|0.73|1.52|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.52|0.73|0.7833
91641332|NCT01491737|183174183|SUPERIORITY||Difference in ORR|7.6||||0.2537|TWO_SIDED|95.0|-6.0|21.3||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||ORR for Arm A vs Arm B||21.3|-6.0|0.2537
91641333|NCT01491737|183174184|SUPERIORITY||Difference in CBR|1.8||||0.7743|TWO_SIDED|95.0|-11.2|14.8||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||CBR for Arm A vs. Arm B||14.8|-11.2|0.7743
91641334|NCT01491737|183174185|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0181|TWO_SIDED|95.0|0.36|0.91||Test was performed at 2-sided alpha of 5%.|Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the DOR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the DOR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to DOR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.91|0.36|0.0181
91692164|NCT03296527|183279345|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.75||||0.365|TWO_SIDED|95.0|0.4|1.4||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe)||1.40|0.40|0.365
91641335|NCT01491737|183174185|OTHER|Exploratory|Hazard Ratio (HR)|0.62||||0.0205|TWO_SIDED|95.0|0.41|0.93|||Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Final Analysis.||0.93|0.41|0.0205
91641336|NCT01491737|183174186|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5597|TWO_SIDED|95.0|0.78|1.57||Test was performed at 2-sided alpha of 5%.|Log Rank|The log-rank test from unstratified analysis was based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including the induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Log Rank tested the following: Null Hypothesis (H0): the distribution of the TTR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the TTR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to TTR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||1.57|0.78|0.5597
91641337|NCT02743117|183174200|SUPERIORITY_OR_OTHER||Rate Difference|-1.3|||||TWO_SIDED|95.0|-8.1|1.3||||||||1.3|-8.1|
91641338|NCT02743117|183174201|SUPERIORITY_OR_OTHER||Rate Difference|-8.2|||||TWO_SIDED|95.0|-22.2|4.6||||||Up to Day 8||4.6|-22.2|
91641339|NCT02743117|183174201|SUPERIORITY_OR_OTHER||Rate Difference|-7.4|||||TWO_SIDED|95.0|-21.6|5.9||||||Up to Day 15||5.9|-21.6|
91641340|NCT00620776|183174205|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mixed Models Analysis|||Mixed model analysis (differential slopes over time) comparing the 26 patients who received combined treatment with at least one CBT session to the 35 patients randomized to venlafaxine XR alone (and received at least one dose) on HAM-A total scores. Only available scores were used (no imputation for missing data). Because the HAM-A demonstrated a relatively rapid improvement early in treatment and then a leveling off, a shifted log-transformation of time of assessment was implemented.||||.17
91641341|NCT00620776|183174206|SUPERIORITY_OR_OTHER|||||||0.54|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.54
91641342|NCT00620776|183174207|SUPERIORITY_OR_OTHER|||||||0.86|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.86
91641343|NCT00620776|183174208|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Data collected at week 24 were analyzed using analysis of covariance (ANCOVA) with the baseline score as the covariate.||||.051
91641344|NCT00620776|183174209|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.06
91674642|NCT01763918|183243034|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.56|STANDARD_ERROR_OF_MEAN|4.97|<|0.001|TWO_SIDED|95.0|-21.38|-1.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-1.74|-21.38|<0.001
91716848|NCT01791985|183325910|OTHER||Mean|0.08|STANDARD_DEVIATION|0.32|||TWO_SIDED|||||||||Proportion of change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in ER positive breast cancer patients who have progressed on treatment with either anastrozole or letrozole in any setting||||
91641345|NCT00620776|183174210|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.95
91641346|NCT00620776|183174211|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.17
91641347|NCT00620776|183174212|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.53
91641348|NCT00620776|183174213|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA with baseline data as covariate.||||.23
91641349|NCT00620776|183174214|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA including baseline data as covariate.||||.07
91641350|NCT00620776|183174215|SUPERIORITY_OR_OTHER|||||||0.63|||||||Chi-squared|||||||.63
91641351|NCT00620776|183174216|SUPERIORITY_OR_OTHER|||||||0.52|||||||Chi-squared|||||||.52
91641352|NCT04983589|183174217|SUPERIORITY||Percentage Difference|27.3|||<|0.0001|TWO_SIDED|95.0|17.3|37.4||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||37.4|17.3|<0.0001
91641353|NCT04983589|183174218|SUPERIORITY||Percentage Difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||36.0|16.8|<0.0001
91641354|NCT04983589|183174219|SUPERIORITY||Percentage Difference|34.7|||<|0.0001|TWO_SIDED|95.0|22.7|46.7||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated based on the normal approximation using pooled variance without continuity correction.|||46.7|22.7|<0.0001
91674643|NCT01763918|183243035|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|8.38|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|4.36|12.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||12.40|4.36|<0.001
91485819|NCT05021081|182844717|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.|Least-square Mean Difference|0.019|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.029|0.068|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Given no historical data is available, the sample size was not determined based on any empirical sample size calculation. A power analysis was conducted using a paired sample t-test (exact method) with a 2-sided type I error rate 0.05 to estimate statistical power based on different assumptions. The power analysis showed that the statistical power for testing superiority would be approximately 80% or higher with the effect size of -0.05 (mean difference: Test minus Control).||0.068|-0.029|
91485820|NCT03387683|182844751|OTHER||Difference in LSM|0.31121|STANDARD_ERROR_OF_MEAN|0.46184||0.504|TWO_SIDED|95.0|-0.619|1.24141||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo-Dapagliflozin 10 mg)||1.24141|-0.61900|0.504
91485821|NCT03387683|182844752|OTHER||Difference in LSM|1.74969|STANDARD_ERROR_OF_MEAN|2.18363||0.427|TWO_SIDED|95.0|-2.64837|6.14775||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo - Dapagliflozin 10 mg)||6.14775|-2.64837|0.427
91485822|NCT00057876|182844769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|ONE_SIDED|95.0|||||Log Rank|||Log rank test is conducted for OS to see whether the two treatment arms are different in their overall survival probabilities.||||0.017
91641355|NCT04983589|183174220|SUPERIORITY||Percentage Difference|20.6||||0.001|TWO_SIDED|95.0|8.6|32.6||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation using pooled variance without continuity correction.|||32.6|8.6|0.001
91641356|NCT00761969|183174221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression - the outcome being the number of events per person-year.||||<0.001
91641357|NCT00762073|183174238|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.239||||0.5282|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.5282
91641358|NCT00762073|183174238|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.86||||0.0092|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0092
91641359|NCT00762073|183174238|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.009||||0.0174|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0174
91485823|NCT00057876|182844770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|ONE_SIDED|95.0|||||Log Rank|||||||0.25
91485824|NCT00057876|182844771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Fisher Exact|||Compare objective response rate (CR+PR) between two treatment groups||||0.99
91485825|NCT02758171|182844804|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|101.71|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|99.818|103.644|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.644|99.818|<0.0001
91489395|NCT02484690|182851575|SUPERIORITY||Difference in Least Squares Means|32.81||||0.0208|TWO_SIDED|80.0|14.65|50.96||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||50.96|14.65|0.0208
91641360|NCT00762073|183174239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1786|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.1786
91641361|NCT00762073|183174239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0090
91641362|NCT00762073|183174239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0001
91641363|NCT00762073|183174240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4959|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.4959
91641364|NCT00762073|183174240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0040
91641365|NCT00762073|183174240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||<0.0001
91641366|NCT00762073|183174241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0108
91674644|NCT01763918|183243035|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.48|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|5.1|13.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.85|5.10|<0.001
91674645|NCT01763918|183243036|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|4.66|13.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.74|4.66|<0.001
91674646|NCT01763918|183243036|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.07|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|3.48|1466.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||1466|3.48|<0.001
91674647|NCT01763918|183243037|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.63|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-29.46|-15.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.81|-29.46|<0.001
91641367|NCT00762073|183174241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0208|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0208
91674648|NCT01763918|183243037|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.54|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.25|-7.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-7.84|-23.25|<0.001
91641368|NCT00762073|183174241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||<0.0001
91674649|NCT01763918|183243038|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|4.21|<|0.001|TWO_SIDED|95.0|-29.29|-12.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-12.66|-29.29|<0.001
91674650|NCT01763918|183243038|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-9.17|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|95.0|-19.01|0.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||0.68|-19.01|<0.001
91674651|NCT01553747|183243044|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
91674652|NCT01553747|183243044|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
91485826|NCT02758171|182844805|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|99.39|STANDARD_DEVIATION|13.1|<|0.0001|TWO_SIDED|90.0|95.29|103.672|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.672|95.290|<0.0001
91641369|NCT00762073|183174242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1095|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.1095
91641370|NCT00762073|183174242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0264|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0264
91641371|NCT00762073|183174242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0010
91485827|NCT02758171|182844806|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|102.33|STANDARD_DEVIATION|13.6|<|0.0001|TWO_SIDED|90.0|97.945|106.91|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||106.910|97.945|<0.0001
91485828|NCT02758171|182844807|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|107.51|STANDARD_DEVIATION|27.4||0.0027|TWO_SIDED|90.0|98.561|117.282|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||117.282|98.561|0.0027
91485829|NCT02758171|182844808|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|101.44|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|99.574|103.336|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.336|99.574|
91641372|NCT00762073|183174243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3769
91641373|NCT00762073|183174243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9363
91641374|NCT00762073|183174243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1235|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.1235
91641375|NCT00762073|183174244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3444|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3444
91641376|NCT00762073|183174244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9258|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9258
91641377|NCT00762073|183174244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3215|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3215
91641378|NCT00762073|183174245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.6729
91641379|NCT00762073|183174245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8894|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8894
91674653|NCT01553747|183243045|SUPERIORITY|||||||0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.001
91674654|NCT01553747|183243045|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
91674655|NCT01490931|183243079|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value adjusted with Bonferroni corrections for multiple comparisons|t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674656|NCT01490931|183243083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674657|NCT01490931|183243084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674658|NCT01490931|183243085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674659|NCT01490931|183243086|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674660|NCT01490931|183243087|SUPERIORITY_OR_OTHER||||||<|1|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0001
91674661|NCT01490931|183243088|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674662|NCT01490931|183243089|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674663|NCT01490931|183243090|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
91674664|NCT00754494|183243125|SUPERIORITY_OR_OTHER|||||||0.762|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.762
91674665|NCT00754494|183243125|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.125
91674666|NCT00754494|183243125|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.855
91722498|NCT02452190|183337799|SUPERIORITY|A fixed-sequence multiple testing procedure was implemented to test the primary and secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.|CAE rate ratio (reslizumab vs placebo)|0.79||||0.194|TWO_SIDED|95.0|0.562|1.124||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group, randomization stratification factors, and number of prior exacerbations as model factors and the logarithm of treatment duration excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.124|0.562|0.194
91641380|NCT00762073|183174245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1532|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.1532
91641381|NCT00762073|183174246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4197|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.4197
91641382|NCT00762073|183174246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9787|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.9787
91641383|NCT00762073|183174246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8987|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8987
91641384|NCT01265875|183174259|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 4.||||.25
91641385|NCT01265875|183174259|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 7.||||.19
91641386|NCT01265875|183174259|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.27
91641387|NCT01265875|183174261|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 4.||||.52
91641388|NCT01265875|183174261|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.34
91674667|NCT00754494|183243126|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.369
91674668|NCT00754494|183243126|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.085
91641389|NCT00830310|183174264|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<0.001
91641390|NCT00830310|183174265|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
91641391|NCT00830310|183174266|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
91641392|NCT00830310|183174267|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
91641393|NCT00830310|183174268|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.001
91641394|NCT00830310|183174269|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.011
91641395|NCT00830310|183174270|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.038
91641396|NCT00830310|183174271|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
91641397|NCT00830310|183174272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<0.001
91641398|NCT01049360|183174280|SUPERIORITY_OR_OTHER||Least square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.156|0.245||Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|Mixed Models Analysis|||||0.245|0.156|<0.0001
91641399|NCT01049360|183174280|SUPERIORITY_OR_OTHER||Least square mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.158|0.245|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.245|0.158|<0.0001
91641400|NCT01049360|183174281|SUPERIORITY_OR_OTHER||Least square mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.083|0.181|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.181|0.083|<0.0001
91641401|NCT01049360|183174281|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.088|0.185|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.185|0.088|<0.0001
91641402|NCT01049360|183174282|SUPERIORITY_OR_OTHER||Least squares mean difference|0.281|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.333|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.333|0.230|<0.0001
91674669|NCT00754494|183243126|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.233
91674670|NCT00754494|183243127|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.651
91674671|NCT00754494|183243127|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
91674672|NCT00754494|183243127|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.261
91674673|NCT00754494|183243128|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.654
91674674|NCT00754494|183243128|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
91674675|NCT00754494|183243128|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.083
91527869|NCT06173570|182930697|SUPERIORITY||Mean Difference (Net)|-26.97|||<|0.001|TWO_SIDED|95.0|-33.33|-20.62|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-20.62|-33.33|<0.001
91674676|NCT04070287|183243168|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91674677|NCT04070287|183243169|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91674678|NCT04070287|183243170|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91674679|NCT04070287|183243171|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91722499|NCT06001021|183337809|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|-35.55|STANDARD_DEVIATION|17.78||0|TWO_SIDED|90.0|-38.9|-32.19||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||-32.19|-38.90|0.000
91674680|NCT04070287|183243172|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91674681|NCT04070287|183243173|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91674682|NCT01949116|183243197|NON_INFERIORITY|The P-value for the risk difference is from an asymptotic non-inferiority analysis for the proportion (risk) difference with a 15% non-inferiority margin.|Risk Difference (RD)|0.072||||0.0367|ONE_SIDED|90.0||0.134|||Farrington-Manning score (exact)||LDMTX - Placebo|||0.134||0.0367
91674683|NCT01949116|183243198|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.55|TWO_SIDED|95.0|-0.67|0.85|||Wilcoxon (Mann-Whitney)|Stratified by Statin Use (study stratification factor)||||0.85|-0.67|0.55
91674684|NCT03399318|183243211|SUPERIORITY||||||<|0.0001||||||treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. A t-test for significance of the treatment effect, were derived from this model.|t-test, 2 sided|||The analysis of the primary outcome variable, Tmax, involved fitting an analysis of 206 covariance model with treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. The estimated 208 treatment effect and associated 95% confidence interval, as well as a t-test for significance of the treatment effect, were derived from this model.||||<0.0001
91641403|NCT01049360|183174282|SUPERIORITY_OR_OTHER||Least squares mean difference|0.275|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.224|0.325|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.325|0.224|<0.0001
91641404|NCT02276274|183174283|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
91674685|NCT03399318|183243212|SUPERIORITY||Odds Ratio (OR)|0.09|||<|0.05|TWO_SIDED|95.0|0.03|0.27|||Regression, Logistic|||Seizure occurrence defined as a three-level ordinal variable was analyzed using a 223 multinomial logistic regression model because there was evidence that the proportional odds 224 assumption did not hold. This model included treatment group as the factor of interest and 225 country and disease severity as stratification factors. The adjusted treatment group odds ratio, 226 and its associated 95% confidence interval were derived from this model.||.27|.03|<0.05
91674686|NCT03399318|183243213|SUPERIORITY||Odds Ratio, log|6.3|||<|0.05|TWO_SIDED|95.0|-5.1|17.7||The covariance matrix for the within-participant observations was 232 modeled using an unstructured pattern.|ANCOVA|Time to parasite clearance was 235 evaluated using a discrete-time proportional hazards model with a complementary log-log link.|The adjusted treatment group difference in mean area 233 under the log10(HRP2 level) × time curve was estimated using appropriate contrasts among the 234 treatment group means over time that quantify this comparison.|Parasite clearance measured by log10 (HRP2 level) was analyzed with a repeated 228 measures analysis of covariance model (mixed model repeated measures)35 with terms for 229 treatment group, country, disease severity, log10(HRP2 level) at admission, time (treated as a 230 categorical variable), and interaction terms for admission log10(HRP2 level) and time, and for 231 treatment group and time.|The model included terms for treatment group, country, and disease severity.|17.7|-5.1|<0.05
91674687|NCT03399318|183243214|SUPERIORITY||Odds Ratio (OR)|0.32|||<|0.05|TWO_SIDED|95.0|0.2|0.52||An ordinal logistic regression model assuming 216 proportional odds with terms for treatment group, country, and disease severity as covariates was used to derive the estimated adjusted treatment group odds ratio and 95%CI|Regression, Logistic|Sensitivity analyses with best-case and worst-case imputation were 219 performed to accommodate missing data||A secondary efficacy measure included fever exposure as measured by the area under 214 the temperature × time curve for T≥38.5°C during the 72-hour follow-up period, categorized as 215 0, \> 0 and \< 2, and ≥ 2 degree-hours.||.52|.20|<0.05
91674688|NCT04632706|183243219|OTHER|||||||0.803||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.803
91674689|NCT04632706|183243221|OTHER|||||||0.689||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.689
91716849|NCT01103323|183325915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.005178||95.0|0.636|0.942||According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).|Log Rank||Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O'Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.||0.942|0.636|0.005178
91716850|NCT01103323|183325916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|1e-06||95.0|0.419|0.582||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Log Rank||Hazard ratio (Regorafenib / Placebo)|Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.||0.582|0.419|<0.000001
91674690|NCT02994355|183243236|SUPERIORITY||Prevalence rate ratio|1.33|||<|0.05|TWO_SIDED|95.0|1.16|1.52|||Poisson Regression|||||1.52|1.16|<0.05
91674691|NCT02994355|183243237|SUPERIORITY||Prevalence rate ratio|1.27|||<|0.05|TWO_SIDED|95.0|1.15|1.3|||Poisson regression|||||1.30|1.15|<0.05
91674692|NCT02994355|183243238|SUPERIORITY||Prevalence rate ratio|3.23|||<|0.05|TWO_SIDED|95.0|2.29|4.55|||Poisson regression|||||4.55|2.29|<0.05
91674693|NCT03050918|183243239|SUPERIORITY|||||||0.05||||||we used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
91674694|NCT03050918|183243240|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
91674695|NCT03050918|183243240|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
91674696|NCT03050918|183243241|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
91674697|NCT03050918|183243241|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
91641405|NCT02276274|183174284|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
91641406|NCT02276274|183174285|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1182|||||TWO_SIDED|90.0|-0.0405|0.2769|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.2769|-0.0405|
91641407|NCT02276274|183174287|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0139|||||TWO_SIDED|90.0|-0.0598|0.032|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0320|-0.0598|
91641408|NCT02276274|183174302|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.014|||||TWO_SIDED|90.0|-0.0918|0.0638|||||ANOVA was performed on log-transformed values of AUC (0-48) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0638|-0.0918|
91641409|NCT02276274|183174303|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0934|0.0605|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0605|-0.0934|
91641410|NCT02276274|183174305|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1518|||||TWO_SIDED|90.0|-0.2356|-0.068|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||-0.0680|-0.2356|
91641411|NCT02276274|183174307|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0179|||||TWO_SIDED|90.0|-0.095|0.0591|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0591|-0.0950|
91641412|NCT00145795|183174353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 3 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.81
91641413|NCT00145795|183174354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 6 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.03
91641414|NCT00145795|183174355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 3 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.08
91641415|NCT00145795|183174356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 3 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.29
91641416|NCT00145795|183174357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 6 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.29
91674698|NCT03050918|183243242|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
91674699|NCT03050918|183243243|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||0.05
91674700|NCT03050918|183243244|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
91674701|NCT03050918|183243246|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
91674702|NCT03832738|183243250|SUPERIORITY||Odds Ratio (OR)|1.5||||0.558|TWO_SIDED|95.0|0.39|5.8||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.80|0.39|0.558
91674703|NCT03832738|183243250|SUPERIORITY||Odds Ratio (OR)|3.74||||0.035|TWO_SIDED|95.0|1.07|13.1||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||13.10|1.07|0.035
91641417|NCT00145795|183174358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 6 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.04
91641418|NCT00145795|183174359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 3 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.21
91641419|NCT00145795|183174360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 6 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.61
91641420|NCT04419558|183174363|OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.077||0.6579|TWO_SIDED|95.0|-0.12|0.19|||Mixed Models Analysis|||||0.19|-0.12|0.6579
91641421|NCT01539512|183174372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.1|0.32|||Log Rank|P-value is from stratified log-rank test, adjusted for randomization stratification factors.||||0.32|0.10|< 0.0001
91641422|NCT01539512|183174375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
91641423|NCT01015118|183174377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0239|TWO_SIDED|95.0|0.72|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).||0.98|0.72|0.0239
91641424|NCT01015118|183174378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0286|TWO_SIDED|95.0|0.75|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.75|0.0286
91674704|NCT03832738|183243251|SUPERIORITY||Odds Ratio (OR)|2.26||||0.086|TWO_SIDED|95.0|0.89|5.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.75|0.89|0.086
91674705|NCT03832738|183243251|SUPERIORITY||Odds Ratio (OR)|3.76||||0.006|TWO_SIDED|95.0|1.45|9.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||9.75|1.45|0.006
91674706|NCT03832738|183243252|SUPERIORITY||Odds Ratio (OR)|1.0|||>|0.999|TWO_SIDED|95.0|0.06|17.25||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||17.25|0.06|>0.999
91674707|NCT03832738|183243252|SUPERIORITY||Odds Ratio (OR)|3.86||||0.244|TWO_SIDED|95.0|0.36|41.2||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||41.20|0.36|0.244
91674708|NCT03832738|183243254|SUPERIORITY||Odds Ratio (OR)|5.21||||0.009|TWO_SIDED|95.0|1.38|19.62||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||19.62|1.38|0.009
91526549|NCT01225822|182928304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
91641425|NCT01015118|183174379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0186|TWO_SIDED|95.0|0.72|0.97|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.97|0.72|0.0186
91641426|NCT01015118|183174380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0256|TWO_SIDED|95.0|0.74|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.74|0.0256
91674709|NCT03832738|183243254|SUPERIORITY||Odds Ratio (OR)|7.35||||0.002|TWO_SIDED|95.0|1.86|29.08||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||29.08|1.86|0.002
91674710|NCT03852459|183243264|SUPERIORITY|||||||0.4272|||||||ANCOVA|||||||0.4272
91674711|NCT05486065|183243280|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.25|-0.39|||ANCOVA|||||-0.39|-1.25|0.0002
91674712|NCT05486065|183243280|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.77||||0.0003|TWO_SIDED|95.0|-1.19|-0.35|||ANCOVA|||||-0.35|-1.19|0.0003
91674713|NCT05486065|183243280|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.64|||ANCOVA|||||-0.64|-1.50|<.0001
91674714|NCT05486065|183243280|OTHER||Treatment difference|0.05||||0.8305|TWO_SIDED|95.0|-0.38|0.47|||ANCOVA|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.||0.47|-0.38|0.8305
91674715|NCT05486065|183243280|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.3||||0.1678|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||||0.13|-0.72|0.1678
91674716|NCT05486065|183243280|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.25||||0.2445|TWO_SIDED|95.0|-0.67|0.17|||ANCOVA|||||0.17|-0.67|0.2445
91485830|NCT02758171|182844809|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|98.15|STANDARD_DEVIATION|15.2|||TWO_SIDED|90.0|93.456|103.082|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.082|93.456|
91641427|NCT01015118|183174381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8653|TWO_SIDED|95.0|0.83|1.17|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.17|0.83|0.8653
91641428|NCT01015118|183174382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0749|TWO_SIDED|95.0|0.77|1.01|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.01|0.77|0.0749
91641429|NCT01015118|183174383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.349|TWO_SIDED|95.0|0.81|1.82|||Regression, Logistic||An odds ratio \>1 favours nintedanib.|Odds ratio and p-value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.82|0.81|0.3490
91641430|NCT01015118|183174384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.29|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|3.88|6.69|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||6.69|3.88|<0.0001
91641431|NCT01015118|183174385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|0.75||0.0124|TWO_SIDED|95.0|-3.35|-0.41|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||-0.41|-3.35|0.0124
91641432|NCT01522755|183174388|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91641433|NCT01522755|183174389|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91641434|NCT01522755|183174390|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91641435|NCT03414658|183174391|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.025|TWO_SIDED|80.0|0.35|0.81|||Log Rank|||||0.81|0.35|0.025
91641436|NCT03414658|183174391|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.32|TWO_SIDED|80.0|0.8|1.64|||Log Rank|||||1.64|0.8|0.32
91641437|NCT02388906|183174395|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0003|TWO_SIDED|95.0|0.6|0.86|||Log Rank|Stratified log rank||||0.86|0.60|0.0003
91641438|NCT02388906|183174396|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.03|0.69|1.11|||Log Rank||Stratified Cox proportional hazard model|||1.11|0.69|
91641439|NCT02388906|183174403|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.9|||Log Rank|Stratified log rank||||0.90|0.63|
91641440|NCT00412360|183174412|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.||||0.17
91641441|NCT00412360|183174413|SUPERIORITY|||||||0.11||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.||||0.11
91641442|NCT00412360|183174414|SUPERIORITY|||||||0.29||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.||||0.29
91641443|NCT00412360|183174414|SUPERIORITY|||||||0.04||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.||||0.04
91641444|NCT00412360|183174416|SUPERIORITY|||||||0.78||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.78
91641445|NCT00412360|183174416|SUPERIORITY|||||||0.02||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.02
91641446|NCT00412360|183174417|SUPERIORITY|||||||0.51||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.51
91485831|NCT03840174|182844825|OTHER||GMT Ratio|77.7|||||TWO_SIDED|95.0|23.9|252.4|||||Geometric Mean Titer (GMT) ratio and 95% CI were estimated using an ANOVA model.|||252.4|23.9|
91641447|NCT00412360|183174417|SUPERIORITY|||||||0.05||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.05
91641448|NCT00412360|183174419|SUPERIORITY|||||||0.12||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.||||0.12
91641449|NCT00412360|183174420|SUPERIORITY|||||||0.43||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.||||0.43
91641450|NCT01790633|183174424|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.||||<0.001
91641451|NCT01790633|183174425|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||||||0.7
91641452|NCT05436067|183174431|OTHER||||||<|0.001||||||Difference in head angle pitch - left between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
91641453|NCT05436067|183174431|OTHER||||||<|0.001||||||Difference in head angle pitch - right between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
91641454|NCT05436067|183174431|OTHER|||||||0.042||||||Difference in head angle yaw - extension between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.042
91485832|NCT02617888|182844850|SUPERIORITY||Slope|0.08|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
91641455|NCT05436067|183174431|OTHER|||||||0.111||||||Difference in head angle yaw - flexion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.111
91641456|NCT05436067|183174432|OTHER|||||||0.023||||||Difference in pitch range of motion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.023
91641457|NCT05436067|183174432|OTHER||||||<|0.001|||||||paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
91641458|NCT05436067|183174433|OTHER|||||||0.057||||||Difference in pitch velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.057
91641459|NCT05436067|183174433|OTHER|||||||0.003||||||Difference in yaw velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.003
91641460|NCT05436067|183174434|OTHER|||||||0.035||||||Weight shift exercise - mediolateral range of motion|paired t-test|||||||0.035
91641461|NCT05436067|183174434|OTHER|||||||0.006||||||Weight shift balance exercise anteroposterior range of motion|paired t-test|||||||0.006
91641462|NCT05436067|183174434|OTHER|||||||0.024||||||Single leg balance range of motion|paired t-test|||||||0.024
91641463|NCT05436067|183174434|OTHER|||||||0.257||||||Single leg balance fluency|Shapiro Wilcoxon test|Data was not normally distributed.||||||0.257
91641464|NCT05689554|183174443|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.944|1.306|||Log Rank|||||1.306|.944|0.11
91641465|NCT05689554|183174444|SUPERIORITY||Risk Ratio (RR)|1.24||||0.183|TWO_SIDED|95.0|0.9|1.7|||Regression, modified Poisson|||||1.7|.9|0.183
91641466|NCT00157157|183174458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.95||||||95.0|1.29|19.06||||||||19.06|1.29|
91641467|NCT00157157|183174459|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||||95.0|1.18|14.82||||||||14.82|1.18|
91641468|NCT00157157|183174460|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5||||||95.0|1.05|19.25||||||||19.25|1.05|
91641469|NCT01678794|183174461|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
91641470|NCT01678794|183174462|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91641471|NCT02260804|183174466|EQUIVALENCE|The equivalence margin of ±17% was predefined.|Difference in proportion|1.8|||||TWO_SIDED|90.0|-6.43|10.2||||||||10.2|-6.43|
91641472|NCT00563706|183174475|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-12.3||||0.043|TWO_SIDED|95.0|-24.24|-0.37|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||-0.37|-24.24|0.043
91641473|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77||||0.457|TWO_SIDED|95.0|-24.7|11.16|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||11.16|-24.70|0.457
91641474|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.61||||0.067|TWO_SIDED|95.0|-24.03|0.81|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.81|-24.03|0.067
91641475|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.61||||0.567|TWO_SIDED|95.0|-16.02|8.8|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.80|-16.02|0.567
91641476|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9||||0.07|TWO_SIDED|95.0|-22.71|0.92|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.92|-22.71|0.070
91641477|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.647|TWO_SIDED|95.0|-16.87|10.5|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||10.50|-16.87|0.647
91641478|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73||||0.075|TWO_SIDED|95.0|-20.46|1.0|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||1.00|-20.46|0.075
91641479|NCT00563706|183174475|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44||||0.765|TWO_SIDED|95.0|-10.92|8.04|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.04|-10.92|0.765
91674717|NCT00595335|183243338|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||Comparison of the change between the two groups' CAS score at 6 months.||||0.73
91674718|NCT00595335|183243339|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 6 months.||||0.75
91716851|NCT01103323|183325917|SUPERIORITY_OR_OTHER||Difference|-0.6||||0.188432||95.0|-1.74|0.53||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||0.53|-1.74|0.188432
91485833|NCT00568685|182844861|SUPERIORITY_OR_OTHER|||||||0.0048||95.0||||This is the p value for CGI-ADHD-S score change at endpoint|Mixed Models Analysis|||||||0.0048
91485834|NCT00568685|182844862|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||This is the p value for CGI-ADHD-I score change at endpoint|Mixed Models Analysis|||||||0.0153
91641480|NCT04074109|183174484|OTHER|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
91674719|NCT00595335|183243339|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
91674720|NCT00595335|183243341|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Comparison of the change between the two groups in proptosis in the right eye at 12 months.||||0.97
91674721|NCT00595335|183243341|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||Comparison of the change between the two groups in change in proptosis in left eye at 12 months.||||0.86
91674722|NCT00595335|183243342|SUPERIORITY_OR_OTHER|||||||0.98|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the right eye between the two groups.||||0.98
91674723|NCT00595335|183243342|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the left eye between the two groups.||||0.49
91674724|NCT00595335|183243343|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 6 months.||||0.21
91641481|NCT04074109|183174484|OTHER|||||||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used. We report percentages and frequencies to show feasibility|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
91641482|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|5.96|||<|0.001|TWO_SIDED|95.0|4.0|9.18||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||9.18|4.00|<.001
91641483|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|5.02|||<|0.001|TWO_SIDED|95.0|3.36|7.76||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||7.76|3.36|<.001
91641484|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.17|5.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||5.17|2.17|<.001
91641485|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|3.28||||0.038|TWO_SIDED|95.0|1.16|11.71||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||11.71|1.16|.038
91674725|NCT00595335|183243343|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 12 months.||||0.64
91674726|NCT00595335|183243344|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 6 months.||||0.36
91641486|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|2.01||||0.256|TWO_SIDED|95.0|0.63|7.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||7.54|0.63|.256
91641487|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|1.5||||0.531|TWO_SIDED|95.0|0.43|5.89||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||5.89|0.43|.531
91641488|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|1.19||||0.202|TWO_SIDED|95.0|0.91|1.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||1.54|0.91|.202
91641489|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||0.88|0.49|.005
91641490|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|0.75||||0.276|TWO_SIDED|95.0|0.69|4.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||4.16|0.69|.276
91641491|NCT03965754|183174503|SUPERIORITY||Odds Ratio (OR)|0.75||||0.592|TWO_SIDED|95.0|0.25|2.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||2.16|0.25|.592
91641492|NCT03965754|183174504|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).|Odds Ratio (OR)|1.31||||0.02|TWO_SIDED|95.0|1.04|1.65||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.65|1.04|.020
91641493|NCT03965754|183174504|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.75||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).||0.75|0.44|<.001
91641494|NCT03965754|183174504|SUPERIORITY||Odds Ratio (OR)|0.75||||0.359|TWO_SIDED|95.0|0.41|1.38||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).||1.38|0.41|.359
91674727|NCT00595335|183243344|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 6 months.||||0.91
91485835|NCT00568685|182844863|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value relates to the sum of adverse events leading to discontinuation.|Fisher Exact|||||||.4500
91485836|NCT00568685|182844864|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.0240
91674728|NCT00595335|183243344|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 12 months.||||0.29
91674729|NCT00595335|183243344|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 12 months.||||0.18
91674730|NCT00595335|183243345|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
91485837|NCT00568685|182844866|SUPERIORITY_OR_OTHER|||||||0.8005||95.0||||This is the p value for heart rate change at endpoint|ANOVA|||||||0.8005
91485838|NCT00568685|182844867|SUPERIORITY_OR_OTHER|||||||0.4128||95.0||||This is the p value for temperature change at endpoint|ANOVA|||||||0.4128
91485839|NCT00568685|182844868|SUPERIORITY_OR_OTHER|||||||0.9761||95.0||||This is the p value for systolic change at endpoint|ANOVA|||||||0.9761
91485840|NCT00568685|182844868|SUPERIORITY_OR_OTHER|||||||0.6419||95.0||||This is the p value for diastolic change at endpoint|ANOVA|||||||0.6419
91485841|NCT00568685|182844869|SUPERIORITY_OR_OTHER|||||||0.2213||95.0||||This is the p value for weight change at endpoint|ANOVA|||||||0.2213
91641495|NCT03965754|183174504|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).|Odds Ratio (OR)|1.72||||0.035|TWO_SIDED|95.0|1.05|2.9|||Regression, Logistic|We used an a priori threshold of p \< .05.||||2.90|1.05|.035
91641496|NCT02983305|183174505|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area at baseline.||||.0001
91641497|NCT02983305|183174505|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area under intervention conditions.||||0.0001
91641498|NCT02983305|183174505|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.003||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.||||.003
91641499|NCT02983305|183174506|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.38||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed at baseline.||||0.38
91641500|NCT02983305|183174506|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.27||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed under intervention conditions.||||0.27
91641501|NCT02983305|183174506|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.79||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the gait speed detected between baseline and intervention.||||0.79
91641502|NCT00706901|183174507|NON_INFERIORITY_OR_EQUIVALENCE|Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
91641503|NCT00706901|183174507|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||zero-hurdle Poisson model|||||||0.02
91641504|NCT00706901|183174508|NON_INFERIORITY_OR_EQUIVALENCE|A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
91641505|NCT00706901|183174508|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.0002|TWO_SIDED||||||Zero-hurdle Poisson model|||||||.0002
91641506|NCT00706901|183174509|NON_INFERIORITY_OR_EQUIVALENCE|To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.||||||0.04|TWO_SIDED||||||Weibull mixture model|||||||0.04
91641507|NCT00706901|183174509|NON_INFERIORITY_OR_EQUIVALENCE|A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
91641508|NCT00706901|183174510|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
91641509|NCT00706901|183174510|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero-hurdle Poisson model|||||||<.0001
91641510|NCT00706901|183174511|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero inflated Poisson model|||||||<.0001
91674731|NCT01013649|183243366|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.62|TWO_SIDED|95.0|0.79|1.38||One-sided significance level = 0.15|Log Rank||Reference level = Arm I|A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15||1.38|0.79|0.62
91674732|NCT01013649|183243367|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|90.0|0.79|1.18||One-sided significance level = 0.05.|Log Rank||Reference level = Arm III|316 deaths from step 2 randomized patients provides 80% power, with 0.05 1-sided alpha, to detect an OS increase (HR=0.76 in favor of arm IV), corresponding to increasing median OS from 17 to 22.5 months with the addition of RT. For analysis triggered by patients having 5 years potential follow-up from step 2 randomization, it is projected that at least 265 events will be observed, providing at least 72% power. The trigger used for the primary analysis was 5-years of follow-up (270 deaths).||1.18|0.79|0.38
91674733|NCT01013649|183243368|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.8|1.31|||||Reference level = Arm I|||1.31|0.80|
91674734|NCT01013649|183243369|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|90.0|0.68|0.99|||||Reference level = Arm III|||0.99|0.68|
91641511|NCT00706901|183174511|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.02
91641512|NCT00706901|183174512|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.||||||0.17|TWO_SIDED||||||Zero inflated Poisson model|||||||0.17
91641513|NCT00706901|183174512|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.67|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.67
91641514|NCT03433482|183174514|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% confidence interval (CI) for the hSBA GMT ratio for serogroup A between the MenACWY liquid vaccine aged for approximately 24 months and the licensed MenACWY vaccine is \> 0.5.|GMT ratio|1.21|||||TWO_SIDED|95.0|0.94|1.57|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 24 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.57|0.94|
91641515|NCT03433482|183174514|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratios for serogroup A between the MenACWY liquid vaccine aged for approximately 30 months and the licensed MenACWY vaccine is \> 0.5. Non-inferiority hypotheses testing will be conducted sequentially, starting from MenACWY liquid vaccine aged for approximately 24 months and subsequently with MenACWY liquid vaccine aged for approximately 30 months.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.87|1.42|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 30 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination.||1.42|0.87|
91641516|NCT03433482|183174515|OTHER||GMT ratio|0.84|||||TWO_SIDED|95.0|0.58|1.19|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup C||1.19|0.58|
91674735|NCT01131299|183243397|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||The minimum sample size to detect an 8 mg/dl change in total plasma cholesterol between the placebo and alpha cyclodextrin periods is 62 subjects. The power is 80% by using the normal approximation to a one-sample (paired) two-tail t-test at an alpha of 0.05.||||0.82
91674736|NCT01131299|183243398|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91674737|NCT01131299|183243399|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91674738|NCT01131299|183243400|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91716852|NCT01103323|183325918|SUPERIORITY_OR_OTHER||Difference|-25.94|||<|1e-06||95.0|-32.06|-19.82||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||-19.82|-32.06|<0.000001
91716853|NCT04536701|183325931|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||Total DASS score reported.||||0.444
91716854|NCT04536701|183325931|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||Depressive Mood DASS score reported||||0.8378
91716855|NCT04536701|183325931|SUPERIORITY|||||||0.4087|||||||t-test, 2 sided|||Anxiety DASS score reported||||0.4087
91527870|NCT06173570|182930697|SUPERIORITY||Mean Difference (Net)|-36.29|||<|0.001|TWO_SIDED|95.0|-42.5|-30.08|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-30.08|-42.50|<0.001
91674739|NCT00118378|183243432|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||< 0.001
91674740|NCT00118378|183243433|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
91674741|NCT00118378|183243434|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANOVA|||Week 4 CD4 cell count||||.150
91674742|NCT00118378|183243435|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED|95.0|||||ANOVA|||||||.459
91674743|NCT00836719|183243455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.01||95.0|3.4|16.2|||Mixed Models Analysis|Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.|Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.|N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.||16.2|3.4|<0.01
91674744|NCT02119286|183243473|SUPERIORITY_OR_OTHER||Least squared mean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.091|0.152|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.152|0.091|<0.001
91716856|NCT04536701|183325931|SUPERIORITY|||||||0.4124|||||||t-test, 2 sided|||Stress DASS score reported||||0.4124
91716857|NCT04536701|183325932|SUPERIORITY|||||||0.0508|||||||t-test, 2 sided|||Total RMBPC frequency reported||||0.0508
91716858|NCT04536701|183325932|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||Frequency of disruptive symptoms on RMBP reported||||0.026
91716859|NCT04536701|183325932|SUPERIORITY|||||||0.1861|||||||t-test, 2 sided|||Frequency of depressive symptoms on RMBPC reported||||0.1861
91716860|NCT04536701|183325932|SUPERIORITY|||||||0.9535|||||||t-test, 2 sided|||Frequency of memory symptoms on RMBPC reported||||0.9535
91716861|NCT04536701|183325932|SUPERIORITY|||||||0.0411|||||||t-test, 2 sided|||RMBPC reaction total is reported||||0.0411
91674745|NCT02119286|183243473|SUPERIORITY_OR_OTHER||Least squared mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.081|0.141|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.141|0.081|<0.001
91674746|NCT02119286|183243474|SUPERIORITY_OR_OTHER||Least squared mean difference|0.147|||<|0.001|TWO_SIDED|95.0|0.114|0.179|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.179|0.114|<0.001
91674747|NCT02119286|183243474|SUPERIORITY_OR_OTHER||Least squared mean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.103|0.167|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.167|0.103|<0.001
91674748|NCT01272921|183243481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||<|0.001|TWO_SIDED|95.0|0.49|0.54|||Z score|||||0.54|0.49|<0.001
91674749|NCT01272921|183243481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.18|0.21|||Z score|||||0.21|0.18|<0.001
91674750|NCT01272921|183243482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-17.0|-6.0||Post hoc comparison were made against the 30-mL volume group and corrected for 6 comparisons using the Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-17.00|0.05
91716862|NCT04536701|183325932|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||RMBPC reaction disruptive symptoms is reported||||0.0058
91716863|NCT04536701|183325932|SUPERIORITY|||||||0.2527|||||||t-test, 2 sided|||RMBPC reaction depressive symptoms is reported||||0.2527
91716864|NCT04536701|183325932|SUPERIORITY|||||||0.3542|||||||t-test, 2 sided|||RMBPC reaction memory symptoms||||0.3542
91716865|NCT04536701|183325933|SUPERIORITY|||||||0.3857|||||||t-test, 2 sided|||||||0.3857
91716866|NCT04536701|183325934|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||Five Facet Mindfulness Questionnaire (FFMQ) total reported||||0.7213
91716867|NCT04536701|183325934|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FFMQ Observing reported||||0.6075
91716868|NCT04536701|183325934|SUPERIORITY|||||||0.4136|||||||t-test, 2 sided|||FFMQ Describing reported||||0.4136
91641517|NCT03433482|183174515|OTHER||GMT ratio|0.94|||||TWO_SIDED|95.0|0.72|1.24|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup W||1.24|0.72|
91485842|NCT02787551|182844870|SUPERIORITY||Least square (LS) mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.77|-0.508||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.||-0.508|-0.770|<0.0001
91641518|NCT03433482|183174515|OTHER||GMT ratio|1.09|||||TWO_SIDED|95.0|0.82|1.44|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup Y||1.44|0.82|
91641519|NCT03433482|183174515|OTHER||GMT ratio|1.14|||||TWO_SIDED|95.0|0.79|1.64|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup C||1.64|0.79|
91641520|NCT03433482|183174515|OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup W||1.45|0.84|
91641521|NCT03433482|183174515|OTHER||GMT ratio|0.96|||||TWO_SIDED|95.0|0.72|1.26|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup Y||1.26|0.72|
91641522|NCT03433482|183174517|OTHER||Difference in percentage of subjects|2.21|||||TWO_SIDED|95.0|-1.94|6.4|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||6.40|-1.94|
91641523|NCT03433482|183174517|OTHER||Difference in percentage of subjects|-2.12|||||TWO_SIDED|95.0|-8.94|4.72|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||4.72|-8.94|
91641524|NCT03433482|183174517|OTHER||Difference in percentage of subjects|-1.16|||||TWO_SIDED|95.0|-8.11|5.8|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||5.80|-8.11|
91641525|NCT03433482|183174517|OTHER||Difference in percentage of subjects|-1.57|||||TWO_SIDED|95.0|-7.88|4.74|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||4.74|-7.88|
91641526|NCT03433482|183174517|OTHER||Difference in percentage of subjects|-0.12|||||TWO_SIDED|95.0|-4.29|4.07|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||4.07|-4.29|
91641527|NCT03433482|183174517|OTHER||Difference in percentage of subjects|2.85|||||TWO_SIDED|95.0|-3.63|9.3|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||9.30|-3.63|
91641528|NCT03433482|183174517|OTHER||Difference in percentage of subjects|4.01|||||TWO_SIDED|95.0|-2.89|10.88|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||10.88|-2.89|
91641529|NCT03433482|183174517|OTHER||Difference in percentage of subjects|-2.84|||||TWO_SIDED|95.0|-8.91|3.26|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||3.26|-8.91|
91641530|NCT03433482|183174518|OTHER||Difference in percentage of subjects|1.79|||||TWO_SIDED|95.0|-2.69|6.32|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.32|-2.69|
91641531|NCT03433482|183174518|OTHER||Difference in percentage of subjects|6.96|||||TWO_SIDED|95.0|0.01|13.84|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||13.84|0.01|
91641532|NCT03433482|183174518|OTHER||Difference in percentage of subjects|3.13|||||TWO_SIDED|95.0|-3.33|9.58|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||9.58|-3.33|
91641533|NCT03433482|183174518|OTHER||Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-4.86|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||6.80|-4.86|
91641534|NCT03433482|183174518|OTHER||Difference in percentage of subjects|1.46|||||TWO_SIDED|95.0|-2.24|5.22|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||5.22|-2.24|
91641535|NCT03433482|183174518|OTHER||Difference in percentage of subjects|-0.43|||||TWO_SIDED|95.0|-6.32|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||5.46|-6.32|
91641536|NCT03433482|183174518|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.||4.18|-7.05|
91716869|NCT04536701|183325934|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||FFMQ Acting with Awareness reported||||0.8378
91641537|NCT03433482|183174518|OTHER||Difference in percentage of subjects|2.04|||||TWO_SIDED|95.0|-2.81|6.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||6.90|-2.81|
91674751|NCT01272921|183243482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-15.0|-6.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-15.00|0.05
91674752|NCT01272921|183243482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-10.0|-4.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-4.00|-10.00|0.05
91674753|NCT01272921|183243482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-7.0|-2.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-2.00|-7.00|0.05
91674754|NCT04271735|183243492|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91674755|NCT02040779|183243502|SUPERIORITY||LSM difference|0.116||||0.001|TWO_SIDED|95.0|0.048|0.185||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 160 mcg BAI - Placebo BAI|A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.||0.185|0.048|0.0010
91674756|NCT02040779|183243502|SUPERIORITY||LSM difference|0.124||||0.0005|TWO_SIDED|95.0|0.054|0.193||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 80 mcg BAI - Placebo BAI|||0.193|0.054|0.0005
91716870|NCT04536701|183325934|SUPERIORITY|||||||0.7193|||||||t-test, 2 sided|||FFMQ Nonjudging reported||||0.7193
91674757|NCT02040779|183243503|SUPERIORITY||LSM difference|7.911||||0.0443|TWO_SIDED|95.0|0.202|15.621||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||15.621|0.202|0.0443
91674758|NCT02040779|183243503|SUPERIORITY||LSM difference|13.645||||0.0007|TWO_SIDED|95.0|5.843|21.446||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||21.446|5.843|0.0007
91716871|NCT04536701|183325934|SUPERIORITY|||||||0.4145|||||||t-test, 2 sided|||FFMQ Nonreactivity reported||||0.4145
91641538|NCT03433482|183174518|OTHER||Difference in percentage of subjects|1.5|||||TWO_SIDED|95.0|-3.32|6.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.33|-3.32|
91641539|NCT03433482|183174518|OTHER||Difference in percentage of subjects|0.38|||||TWO_SIDED|95.0|-6.6|7.35|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||7.35|-6.60|
91692165|NCT03296527|183279345|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.33||||0.012|TWO_SIDED|95.0|0.13|0.83||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with any preventive intervention||0.83|0.13|0.012
91692166|NCT03296527|183279345|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.49||||0.004|TWO_SIDED|95.0|0.3|0.81||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade) and/or preventive interventions||0.81|0.30|0.004
91692167|NCT03296527|183279345|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.56||||0.029|TWO_SIDED|95.0|0.33|0.95|||Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions||0.95|0.33|0.029
91641540|NCT03433482|183174518|OTHER||Difference in percentage of subjects|-1.26|||||TWO_SIDED|95.0|-7.75|5.23|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||5.23|-7.75|
91641541|NCT03433482|183174518|OTHER||Difference in percentage of subjects|-0.85|||||TWO_SIDED|95.0|-6.69|4.98|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||4.98|-6.69|
91641542|NCT03433482|183174518|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||2.96|-4.24|
91641543|NCT03433482|183174518|OTHER||Difference in percentage of subjects|1.32|||||TWO_SIDED|95.0|-3.99|6.64|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||6.64|-3.99|
91641544|NCT03433482|183174518|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.||9.33|-1.11|
91641545|NCT03433482|183174518|OTHER||Difference in percentage of subjects|0.48|||||TWO_SIDED|95.0|-4.16|5.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||5.13|-4.16|
91641546|NCT03433482|183174519|OTHER||Difference in percentage of subjects|1.29|||||TWO_SIDED|95.0|-3.37|5.99|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||5.99|-3.37|
91641547|NCT03433482|183174519|OTHER||Difference in percentage of subjects|7.23|||||TWO_SIDED|95.0|0.25|14.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||14.13|0.25|
91674759|NCT02040779|183243504|SUPERIORITY||LSM difference|5.405||||0.2014|TWO_SIDED|95.0|-2.905|13.715||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||13.715|-2.905|0.2014
91692168|NCT03296527|183279346|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.52|13.74||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor response||13.74|1.52|0.002
91716872|NCT04536701|183325935|SUPERIORITY|||||||0.5368|||||||t-test, 2 sided|||||||0.5368
91485843|NCT02787551|182844872|SUPERIORITY||Difference in percentage|36.05|||<|0.0001|TWO_SIDED|95.0|28.11|43.99||Threshold for significance \<=0.05|Cochran-Mantel-Haenszel|||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c \< 7% was part of testing).||43.99|28.11|<.0001
91641548|NCT03433482|183174519|OTHER||Difference in percentage of subjects|3.92|||||TWO_SIDED|95.0|-2.57|10.39|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||10.39|-2.57|
91716873|NCT04536701|183325936|SUPERIORITY|||||||0.2845|||||||t-test, 2 sided|||FAD Total reported||||0.2845
91641549|NCT03433482|183174519|OTHER||Difference in percentage of subjects|1.49|||||TWO_SIDED|95.0|-4.44|7.44|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||7.44|-4.44|
91641550|NCT03433482|183174519|OTHER||Difference in percentage of subjects|1.73|||||TWO_SIDED|95.0|-1.94|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||5.46|-1.94|
91641551|NCT03433482|183174519|OTHER||Difference in percentage of subjects|-0.99|||||TWO_SIDED|95.0|-6.66|4.7|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||4.70|-6.66|
91641552|NCT03433482|183174519|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||4.18|-7.05|
91641553|NCT03433482|183174519|OTHER||Difference in percentage of subjects|2.06|||||TWO_SIDED|95.0|-2.67|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||6.80|-2.67|
91641554|NCT03433482|183174519|OTHER||Difference in percentage of subjects|1.75|||||TWO_SIDED|95.0|-3.32|6.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||6.83|-3.32|
91641555|NCT03433482|183174519|OTHER||Difference in percentage of subjects|3.87|||||TWO_SIDED|95.0|-3.0|10.71|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||10.71|-3.00|
91641556|NCT03433482|183174519|OTHER||Difference in percentage of subjects|-0.73|||||TWO_SIDED|95.0|-7.24|5.77|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||5.77|-7.24|
91692169|NCT03296527|183279346|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.24|0.62||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with transfer cancellation due to excessive ovarian response/OHSS risk||0.62|0.24|<0.001
91716874|NCT04536701|183325936|SUPERIORITY|||||||0.1386|||||||t-test, 2 sided|||FAD Problem Solving is reported||||0.1386
91485844|NCT02787551|182844874|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.168|<|0.0001|TWO_SIDED|95.0|-2.001|-1.341||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-1.341|-2.001|<0.0001
91526550|NCT01225822|182928304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
91526551|NCT01225822|182928304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
91641557|NCT03433482|183174519|OTHER||Difference in percentage of subjects|-1.12|||||TWO_SIDED|95.0|-6.99|4.75|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||4.75|-6.99|
91641558|NCT03433482|183174519|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||2.96|-4.24|
91641559|NCT03433482|183174519|OTHER||Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-5.16|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.16|-5.16|
91641560|NCT03433482|183174519|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||9.33|-1.11|
91641561|NCT03433482|183174519|OTHER||Difference in percentage of subjects|0.73|||||TWO_SIDED|95.0|-3.88|5.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.37|-3.88|
91641562|NCT00437294|183174525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||||||The 1-sided significance level was 0.20.|Log Rank|||||||0.237
91641563|NCT00437294|183174530|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||1-sided significance level was 0.20.|Fisher Exact|||||||1.00
91641564|NCT00437294|183174531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.812|||||||Log Rank|||||||0.812
91716875|NCT04536701|183325936|SUPERIORITY|||||||0.7551|||||||t-test, 2 sided|||FAD Communication is reported||||0.7551
91716876|NCT04536701|183325936|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||FAD Roles is reported||||0.7213
91641565|NCT00437294|183174532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||Log Rank|||||||0.181
91641566|NCT00461591|183174536|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1068|TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.54|0.1068
91641567|NCT00461591|183174537|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0412|TWO_SIDED|95.0|0.59|0.99|||Log Rank|||||0.99|0.59|0.0412
91641568|NCT00518531|183174564|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5||||0.0259|TWO_SIDED|95.0|1.3|19.7||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||19.7|1.3|0.0259
91641569|NCT00518531|183174565|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|30.9|||<|0.0001|TWO_SIDED|95.0|20.6|41.3||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||41.3|20.6|<0.0001
91641570|NCT00518531|183174566|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.0138|TWO_SIDED|95.0|2.2|19.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||19.7|2.2|0.0138
91641571|NCT00518531|183174567|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.7|||<|0.0001|TWO_SIDED|95.0|17.6|37.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||37.7|17.6|<0.0001
91641572|NCT00518531|183174568|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8||||0.0291|TWO_SIDED|95.0|1.1|18.5|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||18.5|1.1|0.0291
91716877|NCT04536701|183325936|SUPERIORITY|||||||0.3233|||||||t-test, 2 sided|||FAD Affective Responsiveness is reported||||0.3233
91716878|NCT04536701|183325936|SUPERIORITY|||||||0.2832|||||||t-test, 2 sided|||FAD Affective Involvement is reported||||0.2832
91716879|NCT04536701|183325936|SUPERIORITY|||||||0.6831|||||||t-test, 2 sided|||FAD Behavior Control is reported||||0.6831
91716880|NCT04536701|183325936|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FAD General Functioning is reported||||0.6075
91485845|NCT02787551|182844876|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-1.325|-0.708||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-0.708|-1.325|<0.0001
91485846|NCT02787551|182844878|SUPERIORITY||LS Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-3.42|-2.279||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-2.279|-3.420|<0.0001
91485847|NCT02787551|182844880|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.468|-0.508||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-0.508|-1.468|<0.0001
91641573|NCT00518531|183174569|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.4|||<|0.0001|TWO_SIDED|95.0|18.1|36.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||36.7|18.1|<0.0001
91641574|NCT04621227|183174588|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|202.94|||||TWO_SIDED|90.0|167.14|246.41|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \[Period 4\] vs Rosuvastatin 10mg \[Period 1\])||246.41|167.14|
91641575|NCT04621227|183174588|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|283.73|||||TWO_SIDED|90.0|233.68|344.51|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \[Period 7\] vs Rosuvastatin 10mg \[Period 1\])||344.51|233.68|
91674760|NCT02040779|183243504|SUPERIORITY||LSM difference|10.902||||0.0112|TWO_SIDED|95.0|2.5|19.303||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||19.303|2.500|0.0112
91674761|NCT02040779|183243505|SUPERIORITY||LSM difference|-0.388||||0.0175|TWO_SIDED|95.0|-0.708|-0.068||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.068|-0.708|0.0175
91674762|NCT02040779|183243505|SUPERIORITY||LSM difference|-0.358||||0.0285|TWO_SIDED|95.0|-0.678|-0.038||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.038|-0.678|0.0285
91485848|NCT01224665|182844914|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.86|1.4||Using an intention-to-treat analysis, we specified a stratified log-rank test with a one-sided alpha of 0.025.|Log Rank|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|3-year DFS estimates of 55% among participants undergoing SLND and 65% undergoing ELND were used to estimate the target HR. Assuming exponential DFS distribution, 5 years of enrollment, 3 years of follow-up, and 564 eligible participants, the trial would have 85% power to detect a 28% lower risk of recurrence or death with ELND than SLND.||1.40|0.86|0.45
91485849|NCT01224665|182844915|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.88|1.45|||||Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|We assumed that the standard lymphadenectomy arm has 5-year survival of 55%, so we had 83% statistical power to detect a hazard ratio of 0.72 (55% vs. 65% survival at 5 years).||1.45|0.88|
91485850|NCT02130024|182844953|OTHER||Treatment Effect|0.08||||0.236|TWO_SIDED|95.0|-0.05|0.21|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.21|-0.05|0.236
91526552|NCT01225822|182928304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
91641576|NCT04621227|183174589|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.57|||||TWO_SIDED|90.0|42.27|60.5|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \[Period 5\] vs Midazolam 2mg \[Period 2\])||60.50|42.27|
91641577|NCT04621227|183174589|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.56|||||TWO_SIDED|90.0|42.06|60.78|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \[Period 8\] vs Midazolam 2mg \[Period 2\])||60.78|42.06|
91641578|NCT00124709|183174598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0046||||0.7901|TWO_SIDED|95.0|-0.029|0.0381|||ANCOVA|Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables||"A disease-free day in Step 2 or less was defined as a diary day with variable No or almost no eczema?=yes and medication used variable=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day."||0.0381|-0.0290|0.7901
91641579|NCT01728376|183174610|SUPERIORITY_OR_OTHER||Difference (%)|-2.5|||||TWO_SIDED|95.0|-30.3|25.3|||||Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||25.3|-30.3|
91641580|NCT01728376|183174610|SUPERIORITY_OR_OTHER||Difference (%)|16.3|||||TWO_SIDED|95.0|-13.0|45.7|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||45.7|-13.0|
91641581|NCT01728376|183174610|SUPERIORITY_OR_OTHER||Difference (%)|25.7|||||TWO_SIDED|95.0|-21.0|72.4|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||72.4|-21.0|
91641582|NCT01728376|183174611|SUPERIORITY_OR_OTHER||Difference (%)|5.0|||||TWO_SIDED|95.0|-29.8|39.8|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||39.8|-29.8|
91641583|NCT01728376|183174611|SUPERIORITY_OR_OTHER||Difference (%)|37.9|||||TWO_SIDED|95.0|0.7|75.1|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||75.1|0.7|
91641584|NCT01728376|183174611|SUPERIORITY_OR_OTHER||Difference (%)|-10.0||||||95.0|-60.3|40.3|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||40.3|-60.3|
91674763|NCT02040779|183243506|SUPERIORITY||LSM difference|-0.137||||0.0335|TWO_SIDED|95.0|-0.263|-0.011||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.011|-0.263|0.0335
91674764|NCT02040779|183243506|SUPERIORITY||LSM difference|-0.127||||0.0509|TWO_SIDED|95.0|-0.255|0.001||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||0.001|-0.255|0.0509
91674765|NCT02040779|183243508|SUPERIORITY|||||||0.2384|||||||Log Rank|||||||0.2384
91674766|NCT02040779|183243508|SUPERIORITY|||||||0.0208|||||||Log Rank|||||||0.0208
91674767|NCT00922272|183243525|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91674768|NCT00922272|183243527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.4182|TWO_SIDED|95.0|-3.4|8.1|||ANCOVA|||||8.1|-3.4|0.4182
91716881|NCT01946204|183325937|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.0001|TWO_SIDED|95.0|0.219|0.335|||Log Rank|||Statistical Analysis for TTM by BICR (US Regulatory)||0.335|0.219|<0.0001
91674769|NCT00922272|183243528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||Fisher Exact|||||||0.6705
91674770|NCT00922272|183243529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Affective Flattening||||<0.0001
91674771|NCT00922272|183243529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Alogia||||<0.0001
91674772|NCT00922272|183243529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Avolition-Apathy||||<0.0001
91641585|NCT02411110|183174632|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.505|||||||ANCOVA|Baseline value as a covariate; treatment group and stratification (age: \< 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors.|LiRIS® - Placebo|||||0.505
91674773|NCT00922272|183243529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Anhedonia-Asociality||||<0.0001
91641586|NCT03985982|183174636|SUPERIORITY||||||<|0.001||||||This outcome measure is the first to be assessed in a hierarchical testing sequence using a one-sided alpha of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
91641587|NCT03985982|183174637|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the second test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous test shows statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
91641588|NCT03985982|183174637|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the third test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous two tests show statistical significance at the alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
91641589|NCT03985982|183174637|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the forth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous three tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
91641590|NCT03985982|183174637|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the fifth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous four tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
91641591|NCT03985982|183174637|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the sixth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous five tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
91641592|NCT05981365|183174663|OTHER||Ratio of Geometric LS Means|1.2629|||||TWO_SIDED|90.0|1.1673|1.3663||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3663|1.1673|
91641593|NCT05981365|183174663|OTHER||Ratio of Geometric LS Means|1.1845|||||TWO_SIDED|95.0|1.0758|1.3042||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3042|1.0758|
91641594|NCT05981365|183174664|OTHER||Ratio of Geometric LS Means|1.1929|||||TWO_SIDED|90.0|1.0215|1.393||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3930|1.0215|
91641595|NCT05981365|183174665|OTHER||Ratio of Geometric LS Means|1.1311|||||TWO_SIDED|90.0|1.0496|1.2189||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2189|1.0496|
91641596|NCT05981365|183174666|OTHER||Ratio of Geometric LS Means|0.8228||||||90.0|0.6992|0.9683||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9683|0.6992|
91641597|NCT05981365|183174667|OTHER||Ratio of Geometric LS Means|1.5738|||||TWO_SIDED|90.0|1.4523|1.7054||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.7054|1.4523|
91674774|NCT00922272|183243529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Attention||||<0.0001
91716882|NCT01946204|183325937|SUPERIORITY||Hazard Ratio (HR)|0.279|||<|0.0001|TWO_SIDED|95.0|0.227|0.342|||Log Rank|||Statistical Analysis for TTM by BICR (Ex-US Regulatory)||0.342|0.227|<0.0001
91641598|NCT05981365|183174668|OTHER||Ratio of Geometric LS Means|1.1491|||||TWO_SIDED|90.0|1.0807|1.222||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2220|1.0807|
91674775|NCT00922272|183243530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.8771|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Affective Flattening||0.5|-0.4|0.8771
91674776|NCT00922272|183243530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0584|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Alogia||1.1|0.0|0.0584
91674777|NCT00922272|183243530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5215|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Avolition-Apathy||0.6|-0.3|0.5215
91641599|NCT05981365|183174668|OTHER||Ratio of Geometric LS Means|0.9494|||||TWO_SIDED|90.0|0.8759|1.0291||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0291|0.8759|
91641600|NCT05981365|183174669|OTHER||Ratio of Geometric LS Means|1.3316|||||TWO_SIDED|90.0|1.2558|1.4121||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4121|1.2558|
91641601|NCT05981365|183174670|OTHER||Ratio of Geometric LS Means|1.1282|||||TWO_SIDED|90.0|1.07|1.1896||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1896|1.0700|
91641602|NCT05981365|183174671|OTHER||Ratio of Geometric LS Means|0.8047|||||TWO_SIDED|90.0|0.7173|0.9027||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9027|0.7173|
91641603|NCT05981365|183174672|OTHER||Ratio of Geometric LS Means|2.0611|||||TWO_SIDED|90.0|1.8789|2.2609||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2609|1.8789|
91641604|NCT05981365|183174673|OTHER||Ratio of Geometric LS Means|1.1374|||||TWO_SIDED|90.0|1.0672|1.2122||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2122|1.0672|
91641605|NCT05981365|183174673|OTHER||Ratio of Geometric LS Means|0.9371|||||TWO_SIDED|90.0|0.8643|1.0162||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0162|0.8643|
91641606|NCT05981365|183174674|OTHER||Ratio of Geometric LS Means|1.2713|||||TWO_SIDED|90.0|1.1939|1.3538||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3538|1.1939|
91641607|NCT05981365|183174675|OTHER||Ratio of Geometric LS Means|1.127|||||TWO_SIDED|90.0|1.0688|1.1883||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1883|1.0688|
91641608|NCT05981365|183174676|OTHER||Ratio of Geometric LS Means|0.7973|||||TWO_SIDED|90.0|0.7039|0.9031||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9031|0.7039|
91641609|NCT05981365|183174677|OTHER||Ratio of Geometric LS Means|2.026|||||TWO_SIDED|90.0|1.8496|2.2193||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2193|1.8496|
91674778|NCT00922272|183243530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.4835|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Anhedonia-Asociality||0.7|-0.3|0.4835
91485851|NCT02130024|182844954|OTHER||Treatment Effect|0.02||||0.769|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.15|-0.11|0.769
91485852|NCT02130024|182844955|OTHER||Odds Ratio (OR)|0.84||||0.586|TWO_SIDED|95.0|0.44|1.59|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Baseline to Month 12 Analysis||1.59|0.44|0.586
91674779|NCT00922272|183243530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5723|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Attention||0.7|-0.4|0.5723
91485853|NCT02130024|182844955|OTHER||Odds Ratio (OR)|2.27||||0.11|TWO_SIDED|95.0|0.83|6.22|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Month 12 to Month 24 Analysis||6.22|0.83|0.110
91485854|NCT02130024|182844955|OTHER||Odds Ratio (OR)|1.19||||0.554|TWO_SIDED|95.0|0.67|2.09|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment||Baseline to Month 24 Analysis||2.09|0.67|0.554
91485855|NCT02130024|182844956|OTHER||Treatment Effect|0.99||||0.733|TWO_SIDED|95.0|0.95|1.04|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to \<Month 12 Analysis||1.04|0.95|0.733
91641610|NCT05981365|183174678|OTHER||Ratio of Geometric LS Means|0.7909|||||TWO_SIDED|90.0|0.716|0.8737||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8737|0.7160|
91641611|NCT05981365|183174679|OTHER||Ratio of Geometric LS Means|1.0831|||||TWO_SIDED|90.0|0.9723|1.2065||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2065|0.9723|
91641612|NCT05981365|183174680|OTHER||Ratio of Geometric LS Means|1.3138|||||TWO_SIDED|90.0|1.1871|1.4541||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4541|1.1871|
91641613|NCT05981365|183174681|OTHER||Ratio of Geometric LS Means|0.7958|||||TWO_SIDED|90.0|0.742|0.8534||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8534|0.7420|
91641614|NCT05981365|183174682|OTHER||Ratio of Geometric LS Means|1.0322|||||TWO_SIDED|90.0|0.9531|1.1179||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1179|0.9531|
91641615|NCT05981365|183174683|OTHER||Ratio of Geometric LS Means|1.1975|||||TWO_SIDED|90.0|1.0972|1.3069||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3069|1.0972|
91641616|NCT05981365|183174684|OTHER||Ratio of Geometric LS Means|0.8018|||||TWO_SIDED|90.0|0.7472|0.8604||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8604|0.7472|
91641617|NCT05981365|183174685|OTHER||Ratio of Geometric LS Means|1.063|||||TWO_SIDED|90.0|0.9888|1.1427||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1427|0.9888|
91641618|NCT05981365|183174686|OTHER||Ratio of Geometric LS Means|1.2197|||||TWO_SIDED|90.0|1.1114|1.3385||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3385|1.1114|
91641619|NCT00617175|183174741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Negative binomial regression|||||||<0.001
91641620|NCT00505765|183174766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.5||0.21|TWO_SIDED||||||ANCOVA|||||||0.21
91641621|NCT00505765|183174766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.5||0.44|TWO_SIDED||||||ANCOVA|||||||0.44
91641622|NCT01207219|183174779|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The p-value for statistical significance in these analyses was 0.01 adjusted for multiple comparisons .|Mixed Models Analysis|mixed-model analysis with a repeated-measures approach including an unstructured variance matrix||Data analysis was based on the Intention-to-Treatment (ITT) method. Differences between the three intervention groups over time (baseline and 12 weeks) were assessed with a Group x Time interaction term. A priori comparisons of the active intervention groups with the waitlist group were carried out with the same strategy if analyses including all the three groups meet the criterion of statistical significance (P\<0.01).||||<0.01
91641623|NCT01453296|183174806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
91641624|NCT01453296|183174806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
91641625|NCT01453296|183174806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 maximum HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
91641626|NCT01453296|183174807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
91641627|NCT01453296|183174807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
91641628|NCT01453296|183174807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 weighted HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
91641629|NCT01453296|183174808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-4.5|6.6|||||Day 1 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.6|-4.5|
91641630|NCT01453296|183174808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-3.2|6.3|||||Day 14 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.3|-3.2|
91641631|NCT01453296|183174808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-3.0|5.7|||||Day 14 maximum QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-3.0|
91641632|NCT01453296|183174822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01|||||TWO_SIDED|95.0|-2.59|6.61|||||Day 1 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.61|-2.59|
91641633|NCT01453296|183174822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|||||TWO_SIDED|95.0|-1.93|7.81|||||Day 14 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.81|-1.93|
91641634|NCT01453296|183174822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-0.7|7.08|||||Day 14 weighted QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.08|-0.70|
91641635|NCT00766727|183174823|SUPERIORITY||Mean Difference (Final Values)|-31.88|STANDARD_DEVIATION|14.25|||TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||
91641636|NCT01068418|183174831|SUPERIORITY_OR_OTHER||||||<|0.05||||||Threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the mean arterial pressure (mean of five measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.05
91641637|NCT01068418|183174832|SUPERIORITY_OR_OTHER||||||<|0.01||||||threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the renal plasma flow (mean of three measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.01
91641638|NCT00480077|183174836|SUPERIORITY|The primary end point of the study, all-cause death or hospitalization for heart failure, was analyzed on a time-to-first-event basis with the log-rank test. The hazard ratio (HR) associated with allocation to the access arm relative to control was estimated with corresponding 95% confidence interval (CI) by fitting a Cox proportional hazards model containing the treatment group as a categorical factor.||||||0.063|||||||Log Rank|||||||0.063
91641639|NCT01215968|183174852|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.19|||||TWO_SIDED|90.0|1.83|2.62|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 10 over Day 3.||||2.62|1.83|
91641640|NCT01215968|183174852|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.94|||||TWO_SIDED|90.0|1.61|2.33|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 17 over Day 3.||||2.33|1.61|
91641641|NCT01215968|183174852|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.91|||||TWO_SIDED|90.0|1.59|2.29|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 24 over Day 3.||||2.29|1.59|
91641642|NCT01215968|183174852|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.84|||||TWO_SIDED|90.0|1.52|2.22|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 31 over Day 3.||||2.22|1.52|
91641643|NCT05966129|183174857|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7957|TWO_SIDED|95.0|-18.3|23.8|||t-test, 2 sided||||Confidence Interval Width = 42.1|23.8|-18.3|0.7957
91641644|NCT05966129|183174858|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8255|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||||Confidence Interval Width = 0.9|0.5|-0.4|0.8255
91641645|NCT05966129|183174859|SUPERIORITY|||||||0.9054|||||||Wilcoxon (Mann-Whitney)|||||||0.9054
91641646|NCT05966129|183174860|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.248|TWO_SIDED|95.0|-1.9|0.5|||t-test, 2 sided||||Confidence Interval Width = 2.4|0.5|-1.9|0.248
91641647|NCT05966129|183174861|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6012|TWO_SIDED|95.0|-2.7|4.7|||t-test, 2 sided||||Confidence Interval Width = 7.4|4.7|-2.7|0.6012
91641648|NCT05966129|183174862|SUPERIORITY|||||||0.7528|||||||Chi-squared|||||||0.7528
91641649|NCT05966129|183174863|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91641650|NCT05182840|183174864|OTHER||Mean Difference (Net)|-0.168||||0.0499|TWO_SIDED|95.0|-0.337|0.0|||MMRM||"Least Squares Mean of 3 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.000|-0.337|0.0499
91674780|NCT00922272|183243531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Positive subscale||||<0.0001
91674781|NCT00922272|183243531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Negative subscale||||<0.0001
91674782|NCT00922272|183243531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||General Psychopathology subscale||||<0.0001
91526553|NCT01225822|182928304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
91641651|NCT05182840|183174864|OTHER||Mean Difference (Net)|-0.486|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.313|||MMRM||"Least Squares Mean of 10 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.313|-0.660|<.0001
91641652|NCT05182840|183174864|OTHER||Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.596|-0.246|||MMRM||"Least Squares Mean of 20 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.246|-0.596|<.0001
91641653|NCT05182840|183174864|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod Emax model fit|Emax model fit assumption: 80% of the maximum effect is achieved at 10 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
91674783|NCT00922272|183243532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.1975|TWO_SIDED|95.0|-0.3|1.5|||ANCOVA|||Positive subscale||1.5|-0.3|0.1975
91674784|NCT00922272|183243532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.1228|TWO_SIDED|95.0|-0.3|2.3|||ANCOVA|||Negative subscale||2.3|-0.3|0.1228
91674785|NCT00922272|183243532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.1115|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||General Psychopathology subscale||3.9|-0.4|0.1115
91674786|NCT00922272|183243539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0307||95.0|||||t-test, 2 sided|||||||0.0307
91674787|NCT00922272|183243540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1072|TWO_SIDED|95.0|-0.6|6.2|||ANCOVA|||||6.2|-0.6|0.1072
91674788|NCT00922272|183243541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.366||95.0|||||t-test, 2 sided|||||||0.3660
91674789|NCT00922272|183243542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4347|TWO_SIDED|95.0|-5.0|2.2|||ANCOVA|||||2.2|-5.0|0.4347
91674790|NCT00922272|183243543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4312||95.0|||||t-test, 2 sided|||||||0.4312
91674791|NCT00922272|183243544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0874|TWO_SIDED|95.0|-5.4|0.4|||ANCOVA|||||0.4|-5.4|0.0874
91674792|NCT00922272|183243545|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Total Skills||||<0.0001
91674793|NCT00922272|183243545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Communication Skills||||0.0002
91674794|NCT00922272|183243545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||t-test, 2 sided|||Financial Skills||||0.0028
91674795|NCT00922272|183243546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4637|TWO_SIDED|95.0|-5.3|2.4|||ANCOVA|||Total Skills||2.4|-5.3|0.4637
91674796|NCT00922272|183243546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.6137|TWO_SIDED|95.0|-4.1|2.4|||ANCOVA|||Communication Skills||2.4|-4.1|0.6137
91674797|NCT00922272|183243546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.3482|TWO_SIDED|95.0|-3.5|1.3|||ANCOVA|||Financial Skills||1.3|-3.5|0.3482
91674798|NCT00922272|183243547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0174||95.0|||||t-test, 2 sided|||Global Executive Composite||||0.0174
91674799|NCT00922272|183243547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0461||95.0|||||t-test, 2 sided|||Behavioral Recognition Index||||0.0461
91674800|NCT00922272|183243547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||t-test, 2 sided|||Metacognition Index||||0.0146
91674801|NCT00922272|183243548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7418|TWO_SIDED|95.0|-3.8|2.7|||ANCOVA|||Global Executive Composite||2.7|-3.8|0.7418
91674802|NCT00922272|183243548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.6429|TWO_SIDED|95.0|-2.6|4.1|||ANCOVA|||Behavioral Recognition Index||4.1|-2.6|0.6429
91674803|NCT00922272|183243548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4364|TWO_SIDED|95.0|-4.8|2.1|||ANCOVA|||Metacognition Index||2.1|-4.8|0.4364
91674804|NCT03197558|183243559|SUPERIORITY|Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.|Bootstrap method|14.35|||||ONE_SIDED|97.5||14.35||||||Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.||14.35||
91674805|NCT02384941|183243591|SUPERIORITY||Least squares mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|||||Threshold for significance \< 0.05.|MMRM|||||||<0.001
91674806|NCT02384941|183243591|SUPERIORITY||Least squares mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0||||Threshold for significance \< 0.05.|MMRM|||||||< 0.001
91674807|NCT02384941|183243592|SUPERIORITY||Percentage difference|11.8||||0.002|TWO_SIDED|95.0|4.28|19.36||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint of each treatment comparison was statistically significant at 0.05 level.||19.36|4.28|0.002
91674808|NCT02384941|183243592|SUPERIORITY||Percentage difference|21.9|||<|0.001|TWO_SIDED|95.0|14.1|29.64||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||29.64|14.10|< 0.001
91641654|NCT05182840|183174864|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod linear model fit|Linear model fit assumption: No assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
91674809|NCT02384941|183243593|SUPERIORITY||Least squares mean difference|-2.35|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-2.85|-1.85||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.85|-2.85|< 0.001
91674810|NCT02384941|183243593|SUPERIORITY||Least squares mean difference|-3.45|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-3.95|-2.94||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-2.94|-3.95|< 0.001
91674811|NCT02384941|183243594|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.917||0.1|TWO_SIDED|95.0|-3.3|0.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.30|-3.30|0.10
91641655|NCT05182840|183174864|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0.0003|||||||MCPMod exponential model fit|Exponential model fit assumption: 15% of the maximum effect is achieved at 10 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||||0.0003
91641656|NCT05182840|183174865|OTHER||Median Difference (Net)|-15.5|||||TWO_SIDED|95.0|-28.6|0.0|||||"Median of 3 mg BI 690517 - Median of Placebo to BI 690517."|||-0.0|-28.6|
91641657|NCT05182840|183174865|OTHER||Median Difference (Net)|-38.5|||||TWO_SIDED|95.0|-48.3|-26.8|||||"Median of 10 mg BI 690517 - Median of Placebo to BI 690517."|||-26.8|-48.3|
91641658|NCT05182840|183174865|OTHER||Median Difference (Net)|-34.3|||||TWO_SIDED|95.0|-44.9|-21.8|||||"Median of 20 mg BI 690517 - Median of Placebo to BI 690517."|||-21.8|-44.9|
91641659|NCT05182840|183174866|OTHER||Mean Difference (Net)|-0.227||||0.0867|TWO_SIDED|95.0|-0.488|0.033|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.033|-0.488|0.0867
91641660|NCT05182840|183174866|OTHER||Mean Difference (Net)|-0.469||||0.0007|TWO_SIDED|95.0|-0.737|-0.201|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.201|-0.737|0.0007
91641661|NCT05182840|183174866|OTHER||Mean Difference (Net)|-0.429||||0.0027|TWO_SIDED|95.0|-0.707|-0.151|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.151|-0.707|0.0027
91674812|NCT02384941|183243594|SUPERIORITY||Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.916|<|0.001|TWO_SIDED|95.0|-5.09|-1.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.50|-5.09|< 0.001
91674813|NCT02384941|183243595|SUPERIORITY||Least squares mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.48||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.48|-1.50|< 0.001
91674814|NCT02384941|183243596|SUPERIORITY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.8|3.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||3.3|1.8|< 0.001
91716883|NCT01946204|183325938|SUPERIORITY||Hazard Ratio (HR)|0.291|||<|0.0001|TWO_SIDED|95.0|0.238|0.356|||Log Rank|||Statistical Analysis for PFS by BICR (US Regulatory)||0.356|0.238|<0.0001
91716884|NCT01946204|183325938|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.247|0.364|||Log Rank|||Statistical Analysis for PFS by BICR (EX-US Regulatory)||0.364|0.247|<0.0001
91716885|NCT01946204|183325939|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.315|0.634|||Log Rank|||Statistical Analysis for Time to Symptomatic Progression||0.634|0.315|<0.0001
91716886|NCT01946204|183325942|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.227|0.346|||Log Rank|||Statistical Analysis for MFS by BICR (US Regulatory)||0.346|0.227|<0.0001
91716887|NCT01946204|183325942|SUPERIORITY||Hazard Ratio (HR)|0.297|||<|0.0001|TWO_SIDED|95.0|0.244|0.362|||Log Rank|||Statistical Analysis for MFS by BICR (Ex-US Regulatory)||0.362|0.244|<0.0001
91674815|NCT02384941|183243597|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.0|-0.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.5|-1.0|< 0.001
91674816|NCT06005597|183243599|SUPERIORITY||Least Squares (LS) Means|-48.61|STANDARD_ERROR_OF_MEAN|4.959|<|0.0001|TWO_SIDED|95.0|-58.33|-38.89|||ANCOVA|||||-38.89|-58.33|<.0001
91674817|NCT06005597|183243600|SUPERIORITY||Least Squares (LS) Means|-27.94|STANDARD_ERROR_OF_MEAN|4.893|<|0.0001|TWO_SIDED|95.0|-37.53|-18.35|||ANCOVA|||||-18.35|-37.53|<.0001
91674818|NCT06005597|183243601|SUPERIORITY||Least Squares (LS) Means|-16.76|STANDARD_ERROR_OF_MEAN|4.918||0.0007|TWO_SIDED|95.0|-26.4|-7.12|||ANCOVA|||||-7.12|-26.40|0.0007
91674819|NCT06005597|183243602|SUPERIORITY||Least Squares (LS) Means|-31.85|STANDARD_ERROR_OF_MEAN|4.993|<|0.0001|TWO_SIDED|95.0|-41.64|-22.07|||ANCOVA|||||-22.07|-41.64|<.0001
91674820|NCT06005597|183243603|SUPERIORITY||Least Squares (LS) Means|-45.13|STANDARD_ERROR_OF_MEAN|4.233|<|0.0001|TWO_SIDED|95.0|-53.43|-36.84|||ANCOVA|||||-36.84|-53.43|<.0001
91674821|NCT06005597|183243604|SUPERIORITY||Least Squares (LS) Means|-29.19|STANDARD_ERROR_OF_MEAN|3.467|<|0.0001|TWO_SIDED|95.0|-35.99|-22.4|||ANCOVA|||||-22.40|-35.99|<.0001
91674822|NCT06005597|183243605|SUPERIORITY||Least Squares (LS) Means|-29.9|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-38.28|-21.53|||ANCOVA|||||-21.53|-38.28|<.0001
91674823|NCT06005597|183243606|SUPERIORITY||Least Squares (LS) Means|-19.78|STANDARD_ERROR_OF_MEAN|3.549|<|0.0001|TWO_SIDED|95.0|-26.73|-12.82|||ANCOVA|||||-12.82|-26.73|<.0001
91674824|NCT06005597|183243607|SUPERIORITY||Least Squares (LS) Means|-25.44|STANDARD_ERROR_OF_MEAN|4.198|<|0.0001|TWO_SIDED|95.0|-33.67|-17.22|||ANCOVA|||||-17.22|-33.67|<.0001
91674825|NCT06005597|183243608|SUPERIORITY||Least Squares (LS) Means|-14.21|STANDARD_ERROR_OF_MEAN|3.495|<|0.0001|TWO_SIDED|95.0|-21.06|-7.36|||ANCOVA|||||-7.36|-21.06|<.0001
91674826|NCT06005597|183243609|SUPERIORITY||Least Squares (LS) Means|-15.23|STANDARD_ERROR_OF_MEAN|4.236||0.0003|TWO_SIDED|95.0|-23.53|-6.93|||ANCOVA|||||-6.93|-23.53|0.0003
91674827|NCT06005597|183243610|SUPERIORITY||Least Squares (LS) Means|-9.42|STANDARD_ERROR_OF_MEAN|3.493||0.007|TWO_SIDED|95.0|-16.26|-2.57|||ANCOVA|||||-2.57|-16.26|0.007
91674828|NCT05528861|183243641|SUPERIORITY||LSM Difference from Placebo|0.5|STANDARD_ERROR_OF_MEAN|2.1||0.8174|TWO_SIDED|95.0|-3.6|4.5|||ANCOVA|||||4.5|-3.6|0.8174
91674829|NCT05528861|183243642|SUPERIORITY||LSM Difference from Placebo|0.6|STANDARD_ERROR_OF_MEAN|1.1||0.5857|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||||2.8|-1.6|0.5857
91716888|NCT03217591|183325976|SUPERIORITY||Geometric mean change (%)|-16.0|||=|0.2142|TWO_SIDED|90.0|-33.3|5.8|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 20 mg. Geometric mean change (%) and the associated confidence intervals (CIs) were derived as 100×\[exp(Least Squares Mean Change)-1\].||5.8|-33.3|=0.2142
91674830|NCT05528861|183243643|SUPERIORITY||LSM Difference from Placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9633|TWO_SIDED|95.0|-2.2|2.1|||Mixed Models Analysis|||||2.1|-2.2|0.9633
91674831|NCT05528861|183243644|SUPERIORITY||Risk Difference (RD)|6.25||||0.1201|TWO_SIDED|95.0|-11.4|23.78|||Fisher Exact|||||23.78|-11.40|0.1201
91674832|NCT01602172|183243647|EQUIVALENCE|Results of the regression models were used to reject null hypotheses of equivalence with p-values of comparisons across groups in changes in alcohol related measures using p-values \< 0.05 as significant.||||||0.05||||||First, significance of the regression model was viewed. When the overall model was significant, tests of the co-efficients were viewed. Primary effects of interest were the treatment group X time interactions.|Mixed Models Analysis|||Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).||||.05
91674833|NCT01056640|183243659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|STANDARD_ERROR_OF_MEAN|0.2865||0.05|TWO_SIDED|95.0|0.747|2.297|||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test, 2-sample t-test and Chi-square analysis were all used.||All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.||2.297|0.747|0.05
91674834|NCT00518882|183243671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test is below 0.4%|Estimated treatment difference, LS Mean|-0.33|||<|0.0001||95.0|-0.47|-0.18||No multiplicity concerns|ANCOVA|||"ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide \< µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide \< µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%."||-0.18|-0.47|<.0001
91674835|NCT00518882|183243672|SUPERIORITY_OR_OTHER||Mean|0.25|STANDARD_DEVIATION|0.803|<|0.0001||95.0|0.139|0.364|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.364|0.139|<0.0001
91674836|NCT00518882|183243672|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.924||0.9872||95.0|-1.36|0.134|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.134|-1.36|0.9872
91674837|NCT00518882|183243673|SUPERIORITY_OR_OTHER||Mean|-0.98|STANDARD_DEVIATION|1.119|<|0.0001||95.0|-1.137|-0.823|||Paired t-test|||The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.823|-1.137|<0.0001
91716889|NCT03217591|183325976|SUPERIORITY||Geometric mean change (%)|-14.6|||=|0.2718|TWO_SIDED|90.0|-32.7|8.3|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 40 mg. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||8.3|-32.7|=0.2718
91526554|NCT01225822|182928304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
91674838|NCT00518882|183243673|SUPERIORITY_OR_OTHER||Mean|-0.85|STANDARD_DEVIATION|1.105|<|0.0001||95.0|-1.01|-0.687|||Paired t-test|||The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.687|-1.010|<0.0001
91674839|NCT00518882|183243676|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.38||||0.2235||95.0|-0.99|0.23||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.||0.23|-0.99|0.2235
91674840|NCT00518882|183243677|SUPERIORITY_OR_OTHER||Mean|-0.4|STANDARD_DEVIATION|3.24||0.0793||95.0|-0.86|0.05|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.05|-0.86|0.0793
91674841|NCT00518882|183243677|SUPERIORITY_OR_OTHER||Mean|-0.7|STANDARD_DEVIATION|3.67||0.0075||95.0|-1.26|-0.2|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.20|-1.26|0.0075
91674842|NCT00518882|183243678|SUPERIORITY_OR_OTHER||Mean|-3.3|STANDARD_DEVIATION|4.63|<|0.0001||95.0|-3.9|-2.61|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.61|-3.90|<0.0001
91674843|NCT00518882|183243678|SUPERIORITY_OR_OTHER||Mean|-3.2|STANDARD_DEVIATION|4.44|<|0.0001||95.0|-3.85|-2.55|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.55|-3.85|<0.0001
91716890|NCT03217591|183325976|SUPERIORITY||Geometric mean change (%)|-15.3|||=|0.1736|TWO_SIDED|90.0|-30.7|3.6|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat overall. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||3.6|-30.7|=0.1736
91716891|NCT02668640|183326035|OTHER||||||=|0.0002|||||||Wilcoxon signed-rank test|||||||=0.0002
91716892|NCT02668640|183326036|OTHER||||||=|0.0006|||||||Wilcoxon signed-rank test|||||||=0.0006
91527871|NCT06173570|182930697|SUPERIORITY||Mean Difference (Net)|-39.3|||<|0.001|TWO_SIDED|95.0|-45.61|-32.99|||Mixed Models Analysis||Difference = AZD0780 - Placebo; negative values favor AZD0780.|MMRM with fixed effects for baseline of the respective parameter, treatment, visit, treatment-by-visit; random intercept for participants. Missing data imputed using multiple imputation approach detailed in SAP Appendix 7.1.||-32.99|-45.61|<0.001
91674844|NCT00518882|183243679|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-1.01|||<|0.0001||95.0|-1.37|-0.65||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.||-0.65|-1.37|<0.0001
91674845|NCT00518882|183243680|SUPERIORITY_OR_OTHER||Mean|0.7|STANDARD_DEVIATION|1.84|<|0.0001||95.0|0.48|1.0|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78- µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.00|0.48|<0.0001
91674846|NCT00518882|183243680|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|2.42||0.4864||95.0|-0.48|0.23|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.23|-0.48|0.4864
91674847|NCT00518882|183243681|SUPERIORITY_OR_OTHER||Mean|-1.3|STANDARD_DEVIATION|2.5|<|0.0001||95.0|-1.62|-0.92|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.92|-1.62|<0.0001
91674848|NCT00518882|183243681|SUPERIORITY_OR_OTHER||Mean|-0.8|STANDARD_DEVIATION|2.76|<|0.0001||95.0|-1.23|-0.42|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.42|-1.23|<0.0001
91716893|NCT02668640|183326037|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 12||||<0.0001
91716894|NCT02668640|183326037|OTHER||||||=|0.1233|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 12||||=0.1233
91674849|NCT00518882|183243682|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|1.33|||<|0.0001||95.0|0.8|1.86||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.86|0.80|<.0001
91674850|NCT00518882|183243683|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.9849||95.0|-0.52|0.53||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.53|-0.52|0.9849
91674851|NCT00518882|183243684|SUPERIORITY_OR_OTHER||LS Mean|1.01||||0.0005||95.0|0.44|1.57||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.57|0.44|0.0005
91674852|NCT00518882|183243685|SUPERIORITY_OR_OTHER||Mean|-0.22|STANDARD_DEVIATION|2.866||0.2972||95.0|-0.626|0.192|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.192|-0.626|0.2972
91674853|NCT00518882|183243685|SUPERIORITY_OR_OTHER||Mean|1.15|STANDARD_DEVIATION|3.253|<|0.0001||95.0|0.66|1.637|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.637|0.660|<0.0001
91674854|NCT00518882|183243686|SUPERIORITY_OR_OTHER||Mean|0.05|STANDARD_DEVIATION|3.307||0.8396||95.0|-0.424|0.521|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.521|-0.424|0.8396
91674855|NCT00518882|183243686|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|3.419||0.7278||95.0|-0.604|0.423|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.423|-0.604|0.7278
91716895|NCT02668640|183326037|OTHER||||||<|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 24||||<0.001
91674856|NCT00518882|183243687|SUPERIORITY_OR_OTHER||Mean|0.22|STANDARD_DEVIATION|3.053||0.3271||95.0|-0.219|0.654|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.654|-0.219|0.3271
91674857|NCT00518882|183243687|SUPERIORITY_OR_OTHER||Mean|1.07|STANDARD_DEVIATION|3.775||0.0003||95.0|0.497|1.634|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.634|0.497|0.0003
91674858|NCT00518882|183243688|SUPERIORITY_OR_OTHER||Mean|-1.08|STANDARD_DEVIATION|3.662|<|0.0001||95.0|-1.605|-0.562|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.562|-1.605|<0.0001
91674859|NCT00518882|183243688|SUPERIORITY_OR_OTHER||Mean|-0.99|STANDARD_DEVIATION|3.467||0.0003||95.0|-1.517|-0.458|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.458|-1.517|0.0003
91674860|NCT00518882|183243689|SUPERIORITY_OR_OTHER||Mean|0.26|STANDARD_DEVIATION|4.158||0.3859||95.0|-0.331|0.853|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.853|-0.331|0.3859
91674861|NCT00518882|183243689|SUPERIORITY_OR_OTHER||Mean|-0.37|STANDARD_DEVIATION|3.838||0.2119||95.0|-0.956|0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.214|-0.956|0.2119
91674862|NCT00518882|183243690|SUPERIORITY_OR_OTHER||Mean|-0.35|STANDARD_DEVIATION|3.975||0.229||95.0|-0.917|0.2211|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.2211|-0.917|0.2290
91716896|NCT02668640|183326037|OTHER||||||=|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 24||||=0.001
91716897|NCT02668640|183326038|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 12||||<0.0001
91716898|NCT02668640|183326038|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 24||||<0.0001
91485856|NCT02130024|182844956|OTHER||Treatment Effect|1.01||||0.745|TWO_SIDED|95.0|0.95|1.08|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to Month 24 Analysis||1.08|0.95|0.745
91641662|NCT05182840|183174867|OTHER||Median Difference (Net)|-20.3|||||TWO_SIDED|95.0|-38.6|3.4|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||3.4|-38.6|
91641663|NCT05182840|183174867|OTHER||Median Difference (Net)|-37.4|||||TWO_SIDED|95.0|-52.2|-18.2|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517"|||-18.2|-52.2|
91641664|NCT05182840|183174867|OTHER||Median Difference (Net)|-34.9|||||TWO_SIDED|95.0|-50.7|-14.0|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||-14.0|-50.7|
91641665|NCT05182840|183174868|OTHER||Mean Difference (Net)|-0.098||||0.3737|TWO_SIDED|95.0|-0.316|0.119|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.119|-0.316|0.3737
91641666|NCT05182840|183174868|OTHER||Mean Difference (Net)|-0.502|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.275|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.275|-0.730|<.0001
91641667|NCT05182840|183174868|OTHER||Mean Difference (Net)|-0.404||||0.0004|TWO_SIDED|95.0|-0.625|-0.184|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.184|-0.625|0.0004
91641668|NCT05182840|183174869|OTHER||Median Difference (Net)|-9.4|||||TWO_SIDED|95.0|-27.1|12.7|||||"Median of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||12.7|-27.1|
91641669|NCT05182840|183174869|OTHER||Median Difference (Net)|-39.5|||||TWO_SIDED|95.0|-51.8|-24.0|||||"Median of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-24.0|-51.8|
91641670|NCT05182840|183174869|OTHER||Median Difference (Net)|-33.2|||||TWO_SIDED|95.0|-46.5|-16.8|||||"Median of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-16.8|-46.5|
91641671|NCT05182840|183174870|OTHER||Odds Ratio (OR)|2.08||||0.0136|TWO_SIDED|95.0|1.16|3.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.72|1.16|0.0136
91641672|NCT05182840|183174870|OTHER||Odds Ratio (OR)|7.02||||0|TWO_SIDED|95.0|3.94|12.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||12.49|3.94|0.0000
91641673|NCT05182840|183174870|OTHER||Odds Ratio (OR)|5.48||||0|TWO_SIDED|95.0|3.09|9.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.71|3.09|0.0000
91641674|NCT05182840|183174871|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
91641675|NCT05182840|183174871|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
91674863|NCT00518882|183243690|SUPERIORITY_OR_OTHER||Mean|-0.95|STANDARD_DEVIATION|3.23||0.0002||95.0|-1.449|-0.459|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.459|-1.449|0.0002
91674864|NCT00518882|183243691|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.73||||0.0124||95.0|0.16|1.31||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.31|0.16|0.0124
91674865|NCT00518882|183243692|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.39||||0.143||95.0|-0.91|0.13||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.13|-0.91|0.1430
91674866|NCT00518882|183243693|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.54||||0.038||95.0|0.03|1.05||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.05|0.03|0.0380
91674867|NCT00518882|183243694|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|2.827||0.77||95.0|-0.344|0.463|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.463|-0.344|0.7700
91674868|NCT00518882|183243694|SUPERIORITY_OR_OTHER||Mean|0.72|STANDARD_DEVIATION|3.27||0.0042||95.0|0.23|1.212|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.212|0.230|0.0042
91674869|NCT00518882|183243695|SUPERIORITY_OR_OTHER||Mean|0.67|STANDARD_DEVIATION|3.041||0.0026||95.0|0.238|1.106|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.106|0.238|0.0026
91641676|NCT05182840|183174871|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
91674870|NCT00518882|183243695|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|2.989||0.6845||95.0|-0.541|0.356|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.356|-0.541|0.6845
91674871|NCT00518882|183243696|SUPERIORITY_OR_OTHER||Mean|0.32|STANDARD_DEVIATION|2.705||0.1041||95.0|-0.066|0.706|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.706|-0.066|0.1041
91674872|NCT00518882|183243696|SUPERIORITY_OR_OTHER||Mean|0.58|STANDARD_DEVIATION|3.114||0.0151||95.0|0.114|1.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.052|0.114|0.0151
91674873|NCT00518882|183243697|SUPERIORITY_OR_OTHER||Mean|-3.31|STANDARD_DEVIATION|3.857|<|0.0001||95.0|-3.861|-2.763|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.763|-3.861|<0.0001
91674874|NCT00518882|183243697|SUPERIORITY_OR_OTHER||Mean|-3.13|STANDARD_DEVIATION|3.56|<|0.0001||95.0|-3.673|-2.589|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.589|-3.673|<0.0001
91716899|NCT02668640|183326039|OTHER||||||=|0.0137|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12||||=0.0137
91716900|NCT02668640|183326039|OTHER||||||=|0.0607|||||||Wilcoxon signed-rank test|||Median Change from Baseline in Overall Work Impairment Score at Week 24||||=0.0607
91485857|NCT02130024|182844957|OTHER||Treatment Effect|2.32||||0.079|TWO_SIDED|95.0|-0.27|4.92|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||4.92|-0.27|0.079
91526555|NCT01225822|182928305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
91641677|NCT05182840|183174872|OTHER||Odds Ratio (OR)|1.8||||0.0348|TWO_SIDED|95.0|1.04|3.09||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.09|1.04|0.0348
91641678|NCT05182840|183174872|OTHER||Odds Ratio (OR)|4.12||||0|TWO_SIDED|95.0|2.4|7.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.08|2.40|0.0000
91641679|NCT05182840|183174872|OTHER||Odds Ratio (OR)|5.02||||0|TWO_SIDED|95.0|2.91|8.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.67|2.91|0.0000
91641680|NCT05182840|183174873|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
91641681|NCT05182840|183174873|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
91641682|NCT05182840|183174873|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
91641683|NCT05182840|183174874|OTHER||Odds Ratio (OR)|2.44||||0.0419|TWO_SIDED|95.0|1.03|5.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.74|1.03|0.0419
91641684|NCT05182840|183174874|OTHER||Odds Ratio (OR)|6.09||||0|TWO_SIDED|95.0|2.64|14.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.08|2.64|0.0000
91641685|NCT05182840|183174874|OTHER||Odds Ratio (OR)|6.13||||0|TWO_SIDED|95.0|2.64|14.25||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.25|2.64|0.0000
91674875|NCT00518882|183243698|SUPERIORITY_OR_OTHER||Mean|-1.93|STANDARD_DEVIATION|3.703|<|0.0001||95.0|-2.457|-1.403|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.403|-2.457|<0.0001
91485858|NCT02130024|182844957|OTHER||Treatment Effect|1.95||||0.151|TWO_SIDED|95.0|-0.71|4.61|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||4.61|-0.71|0.151
91641686|NCT05182840|183174875|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
91641687|NCT05182840|183174875|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
91641688|NCT05182840|183174875|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
91641689|NCT05182840|183174876|OTHER||Odds Ratio (OR)|2.03||||0.0767|TWO_SIDED|95.0|0.93|4.42||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.42|0.93|0.0767
91641690|NCT05182840|183174876|OTHER||Odds Ratio (OR)|4.11||||0.0003|TWO_SIDED|95.0|1.89|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.89|0.0003
91641691|NCT05182840|183174876|OTHER||Odds Ratio (OR)|4.69||||0.0001|TWO_SIDED|95.0|2.15|10.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.24|2.15|0.0001
91641692|NCT05182840|183174877|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
91641693|NCT05182840|183174877|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
91716901|NCT02668640|183326040|OTHER||||||=|0.0026|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 12||||=0.0026
91641694|NCT05182840|183174877|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
91716902|NCT02668640|183326040|OTHER||||||=|0.0001|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 24||||=0.0001
91641695|NCT05182840|183174878|OTHER||Odds Ratio (OR)|1.82||||0.1398|TWO_SIDED|95.0|0.82|4.04||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.04|0.82|0.1398
91641696|NCT05182840|183174878|OTHER||Odds Ratio (OR)|8.42||||0|TWO_SIDED|95.0|3.73|19.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||19.02|3.73|0.0000
91641697|NCT05182840|183174878|OTHER|P-value was rounded to four decimal places.|Odds Ratio (OR)|4.98||||0.0001|TWO_SIDED|95.0|2.28|10.9|||Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.90|2.28|0.0001
91641698|NCT05182840|183174879|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
91641699|NCT05182840|183174879|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
91641700|NCT05182840|183174879|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
91674876|NCT00518882|183243698|SUPERIORITY_OR_OTHER||Mean|-2.17|STANDARD_DEVIATION|3.654|<|0.0001||95.0|-2.731|-1.618|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.618|-2.731|<0.0001
91674877|NCT00518882|183243699|SUPERIORITY_OR_OTHER||Mean|-2.21|STANDARD_DEVIATION|3.752|<|0.0001||95.0|-2.747|-1.676|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.676|-2.747|<0.0001
91674878|NCT00518882|183243699|SUPERIORITY_OR_OTHER||Mean|-2.55|STANDARD_DEVIATION|3.625|<|0.0001||95.0|-3.104|-1.997|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.997|-3.104|<0.0001
91674879|NCT00518882|183243700|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|29.37|||<|0.0001||95.0|16.81|41.93||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||41.93|16.81|<.0001
91674880|NCT00518882|183243701|SUPERIORITY_OR_OTHER||Mean|-18.18|STANDARD_DEVIATION|62.811|<|0.0001||95.0|-26.988|-9.382|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-9.382|-26.988|<0.0001
91674881|NCT00518882|183243701|SUPERIORITY_OR_OTHER||Mean|2.49|STANDARD_DEVIATION|52.997||0.5304||95.0|-5.327|10.307|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||10.307|-5.327|0.5304
91716903|NCT01121263|183326093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063||||0.8||95.0|0.666|1.697|||Regression, Cox|The Cox proportional hazards regression model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|The Cox model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|This applies to any MACCE||1.697|0.666|0.80
91716904|NCT01121263|183326094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.53||95.0|0.556|1.355|||Regression, Cox||The Cox proportional hazards regression model was weighted by the propensity score to account for the difference in baseline risk between groups.|This applies to any MACCE||1.355|0.556|0.53
91716905|NCT00723229|183326123|SUPERIORITY_OR_OTHER||Incidence Risk Ratio|0.2|||<|0.001|TWO_SIDED|95.0|0.17|0.25|||Regression, poisson|Adjusted for period effects.||The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.||0.25|0.17|<0.001
91716906|NCT00723229|183326123|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.08|||Regression, Poisson|||Among HIV seronegative individuals.||0.08|0.03|<0.001
91485859|NCT02130024|182844958|OTHER||Treatment Effect|10.12||||0.294|TWO_SIDED|95.0|-8.82|29.06|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||29.06|-8.82|0.294
91641701|NCT05182840|183174880|OTHER||Odds Ratio (OR)|1.62||||0.214|TWO_SIDED|95.0|0.76|3.46||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.46|0.76|0.2140
91641702|NCT05182840|183174880|OTHER||Odds Ratio (OR)|4.13||||0.0003|TWO_SIDED|95.0|1.93|8.85||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.85|1.93|0.0003
91641703|NCT05182840|183174880|OTHER||Odds Ratio (OR)|5.43||||0|TWO_SIDED|95.0|2.52|11.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.71|2.52|0.0000
91641704|NCT05182840|183174881|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
91641705|NCT05182840|183174881|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
91716907|NCT00723229|183326123|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.6|||Regression, Poisson|||Among HIV seropositive individuals.||0.6|0.4|<0.001
91716908|NCT02900352|183326132|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.0130
91716909|NCT02900352|183326133|SUPERIORITY|||||||0.148|||||||Chi-squared|||||||0.148
91716910|NCT02900352|183326134|SUPERIORITY|||||||0.054|||||||ANOVA|||||||.054
91716911|NCT02900352|183326135|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
91716912|NCT02900352|183326136|SUPERIORITY|||||||0.889|||||||ANOVA|||||||0.889
91716913|NCT02900352|183326137|SUPERIORITY|||||||0.482|||||||ANOVA|||||||0.482
91716914|NCT02900352|183326138|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91716915|NCT04210986|183326178|SUPERIORITY||Odds Ratio (OR)|0.99|||>|0.9|TWO_SIDED|95.0|0.25|4.02||No adjustment made for multiple comparisons.|Fisher Exact||Odds ratio is for fisetin group, relative to the placebo group.|Null hypothesis: no difference in proportion of participants experiencing any TEAE between Fisetin and Placebo groups.||4.02|0.25|>0.9
91485860|NCT02130024|182844958|OTHER||Treatment Effect|11.86||||0.225|TWO_SIDED|95.0|-7.35|31.07|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||31.07|-7.35|0.225
91485861|NCT02130024|182844959|OTHER||Odds Ratio (OR)|0.83||||0.461|TWO_SIDED|95.0|0.51|1.35|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 2 Analysis||1.35|0.51|0.461
91641706|NCT05182840|183174881|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
91641707|NCT05182840|183174882|OTHER||Odds Ratio (OR)|2.18||||0.0024|TWO_SIDED|95.0|1.32|3.61||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.61|1.32|0.0024
91641708|NCT05182840|183174882|OTHER||Odds Ratio (OR)|4.05||||0|TWO_SIDED|95.0|2.39|6.86||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.86|2.39|0.0000
91641709|NCT05182840|183174882|OTHER||Odds Ratio (OR)|3.87||||0|TWO_SIDED|95.0|2.29|6.55||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.55|2.29|0.0000
91641710|NCT05182840|183174883|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
91641711|NCT05182840|183174883|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
91641712|NCT05182840|183174883|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
91641713|NCT05182840|183174884|OTHER||Odds Ratio (OR)|1.67||||0.0418|TWO_SIDED|95.0|1.02|2.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.74|1.02|0.0418
91674882|NCT00518882|183243702|SUPERIORITY_OR_OTHER||Mean|24.86|STANDARD_DEVIATION|59.326|<|0.0001||95.0|16.348|33.374|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||33.374|16.348|<0.0001
91485862|NCT02130024|182844959|OTHER||Odds Ratio (OR)|0.72||||0.215|TWO_SIDED|95.0|0.44|1.21|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 12 Analysis||1.21|0.44|0.215
91485863|NCT02130024|182844959|OTHER||Odds Ratio (OR)|0.87||||0.616|TWO_SIDED|95.0|0.51|1.48|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 24 Analysis||1.48|0.51|0.616
91485864|NCT02130024|182844960|OTHER||Odds Ratio (OR)|1.05||||0.891|TWO_SIDED|95.0|0.53|2.08|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||2.08|0.53|0.891
91485865|NCT02130024|182844960|OTHER||Odds Ratio (OR)|1.61||||0.206|TWO_SIDED|95.0|0.77|3.35|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||3.35|0.77|0.206
91485866|NCT02130024|182844961|OTHER||Odds Ratio (OR)|1.63||||0.46|TWO_SIDED|95.0|0.45|5.93|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||5.93|0.45|0.460
91641714|NCT05182840|183174884|OTHER||Odds Ratio (OR)|3.91||||0|TWO_SIDED|95.0|2.3|6.65||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.65|2.30|0.0000
91641715|NCT05182840|183174884|OTHER||Odds Ratio (OR)|3.58||||0|TWO_SIDED|95.0|2.11|6.05||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.05|2.11|0.0000
91641716|NCT05182840|183174885|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
91641717|NCT05182840|183174885|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
91641718|NCT05182840|183174885|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
91674883|NCT00518882|183243702|SUPERIORITY_OR_OTHER||Mean|11.13|STANDARD_DEVIATION|87.145||0.092||95.0|-1.835|24.093|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||24.093|-1.835|0.0920
91674884|NCT00518882|183243703|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.11||||0.0946||95.0|-0.23|0.02||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.02|-0.23|0.0946
91674885|NCT00518882|183243704|SUPERIORITY_OR_OTHER||Mean|0.11|STANDARD_DEVIATION|0.774||0.0513||95.0|-0.001|0.216|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.216|-0.001|0.0513
91674886|NCT00518882|183243704|SUPERIORITY_OR_OTHER||Mean|0.12|STANDARD_DEVIATION|0.804||0.0513||95.0|-0.001|0.233|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.233|-0.001|0.0513
91674887|NCT00518882|183243705|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.859||0.2764||95.0|-0.187|0.054|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.054|-0.187|0.2764
91674888|NCT00518882|183243705|SUPERIORITY_OR_OTHER||Mean|0.09|STANDARD_DEVIATION|0.89||0.1911||95.0|-0.043|0.216|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.216|-0.043|0.1911
91674889|NCT00518882|183243706|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.04||||0.4412||95.0|-0.15|0.06||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.06|-0.15|0.4412
91485867|NCT02130024|182844961|OTHER||Odds Ratio (OR)|0.94||||0.913|TWO_SIDED|95.0|0.3|2.9|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||2.90|0.30|0.913
91485868|NCT02130024|182844963|OTHER||Treatment Effect|27.2|||<|0.001|TWO_SIDED|95.0|21.44|32.95|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 5 Analysis||32.95|21.44|<0.001
91641719|NCT05182840|183174886|OTHER||Odds Ratio (OR)|2.2||||0.0285|TWO_SIDED|95.0|1.09|4.45||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.45|1.09|0.0285
91674890|NCT00518882|183243707|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.606||0.4746||95.0|-0.054|0.115|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.115|-0.054|0.4746
91674891|NCT00518882|183243707|SUPERIORITY_OR_OTHER||Mean|0.08|STANDARD_DEVIATION|0.72||0.1281||95.0|-0.024|0.188|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.188|-0.024|0.1281
91674892|NCT00518882|183243708|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|0.604|<|0.0001||95.0|-0.39|-0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.214|-0.390|<0.0001
91674893|NCT00518882|183243708|SUPERIORITY_OR_OTHER||Mean|-0.21|STANDARD_DEVIATION|0.647|<|0.0001||95.0|-0.303|-0.11|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.110|-0.303|<0.0001
91674894|NCT00518882|183243709|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0277||95.0|-0.13|-0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.01|-0.13|0.0277
91674895|NCT00518882|183243710|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.29||0.003||95.0|0.021|0.102|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.102|0.021|0.0030
91674896|NCT00518882|183243710|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.307||0.1452||95.0|-0.012|0.079|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.079|-0.012|0.1452
91674897|NCT00518882|183243711|SUPERIORITY_OR_OTHER||Mean|0.27|STANDARD_DEVIATION|0.306|<|0.0001||95.0|0.223|0.315|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.315|0.223|<0.0001
91674898|NCT00518882|183243711|SUPERIORITY_OR_OTHER||Mean|0.31|STANDARD_DEVIATION|0.346|<|0.0001||95.0|0.259|0.364|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.364|0.259|<0.0001
91674899|NCT00518882|183243712|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.5105||95.0|-0.02|0.04||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.04|-0.02|0.5105
91674900|NCT00518882|183243713|SUPERIORITY_OR_OTHER||Mean|-0.01|STANDARD_DEVIATION|0.15||0.222||95.0|-0.034|0.008|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.008|-0.034|0.2220
91641720|NCT05182840|183174886|OTHER||Odds Ratio (OR)|2.9||||0.0038|TWO_SIDED|95.0|1.41|5.96||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.96|1.41|0.0038
91641721|NCT05182840|183174886|OTHER||Odds Ratio (OR)|4.15||||0.0002|TWO_SIDED|95.0|1.97|8.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.72|1.97|0.0002
91641722|NCT05182840|183174887|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
91641723|NCT05182840|183174887|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
91641724|NCT05182840|183174887|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
91641725|NCT05182840|183174888|OTHER||Odds Ratio (OR)|1.34||||0.4092|TWO_SIDED|95.0|0.67|2.69||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.69|0.67|0.4092
91641726|NCT05182840|183174888|OTHER||Odds Ratio (OR)|3.66||||0.0005|TWO_SIDED|95.0|1.77|7.58||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.58|1.77|0.0005
91641727|NCT05182840|183174888|OTHER||Odds Ratio (OR)|4.04||||0.0002|TWO_SIDED|95.0|1.92|8.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.49|1.92|0.0002
91674901|NCT00518882|183243713|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.141||0.7923||95.0|-0.018|0.024|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.024|-0.018|0.7923
91674902|NCT00518882|183243714|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.159||0.0254||95.0|-0.05|-0.003|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.003|-0.050|0.0254
91674903|NCT00518882|183243714|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.165||0.2244||95.0|-0.04|0.009|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.009|-0.040|0.2244
91674904|NCT00518882|183243715|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.18||||0.0485||95.0|-0.37|0.0||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.00|-0.37|0.0485
91674905|NCT00518882|183243716|SUPERIORITY_OR_OTHER||Mean|0.1|STANDARD_DEVIATION|0.82||0.1161||95.0|-0.02|0.21|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.21|-0.02|0.1161
91674906|NCT00518882|183243716|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.96||0.7888||95.0|-0.16|0.12|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.12|-0.16|0.7888
91716916|NCT04210986|183326179|SUPERIORITY||Contrast of LS Means|-3.5||||0.9728|TWO_SIDED|95.0|-10.6|3.6||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||3.6|-10.6|0.9728
91716917|NCT04210986|183326179|SUPERIORITY||Contrast of LS Means|-2.5||||0.9728|TWO_SIDED|95.0|-7.8|2.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||2.8|-7.8|0.9728
91674907|NCT00518882|183243717|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|1.07||0.0003||95.0|-0.43|-0.13|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.13|-0.43|0.0003
91674908|NCT00518882|183243717|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|1.47||0.2078||95.0|-0.35|0.08|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.08|-0.35|0.2078
91674909|NCT00518882|183243718|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0014||95.0|-0.11|-0.03||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.03|-0.11|0.0014
91674910|NCT00518882|183243719|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.269||0.0018||95.0|0.023|0.098|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.098|0.023|0.0018
91716918|NCT04210986|183326179|SUPERIORITY||Contrast of LS Means|-20.5||||0.0829|TWO_SIDED|95.0|-37.7|-3.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||-3.3|-37.7|0.0829
91716919|NCT04210986|183326179|SUPERIORITY||Contrast of LS Means|-0.5||||0.9728|TWO_SIDED|95.0||||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Contrast of LS Means|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||||0.9728
91485869|NCT02130024|182844963|OTHER||Treatment Effect|28.88|||<|0.001|TWO_SIDED|95.0|23.08|34.68|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 9 Analysis||34.68|23.08|<0.001
91485870|NCT02160990|182845011|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
91485871|NCT02160990|182845012|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
91485872|NCT02160990|182845013|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANCOVA|||||||0.23
91716920|NCT04210986|183326180|SUPERIORITY||Contrast of LS Means|2.52|||>|0.99|TWO_SIDED|95.0|-49.4|54.5||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||54.5|-49.4|>0.99
91716921|NCT04210986|183326180|SUPERIORITY||Contrast of LS Means|11.0|||>|0.99|TWO_SIDED|95.0|-36.8|58.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||58.8|-36.8|>0.99
91485873|NCT03789396|182845070|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic|||Comparison of patient odds of being hyperoxic and not on room air pre- versus post-intervention||0.97|0.57|0.03
91485874|NCT00734474|182845091|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategies.|LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.55|-0.87|<0.001
91485875|NCT00734474|182845091|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.31|-0.63|<0.001
91485876|NCT00734474|182845091|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.55|-0.87|<0.001
91485877|NCT00734474|182845091|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.31|-0.63|<0.001
91716922|NCT04210986|183326180|SUPERIORITY||Contrast of LS Means|-40.3||||0.6594|TWO_SIDED|95.0|-97.6|17.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||17.1|-97.6|0.6594
91722542|NCT02629159|183337904|SUPERIORITY||LS Mean Difference|-16.3|||<|0.001|TWO_SIDED|95.0|-18.89|-13.71||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-13.71|-18.89|<0.001
91485878|NCT00734474|182845093|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|||<|0.001|TWO_SIDED|95.0|-1.42|-1.09||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-1.09|-1.42|<0.001
91485879|NCT00734474|182845093|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.21|-0.88||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.88|-1.21|<0.001
91641728|NCT05182840|183174889|OTHER||Odds Ratio (OR)|2.16||||0.0348|TWO_SIDED|95.0|1.06|4.43||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.43|1.06|0.0348
91641729|NCT05182840|183174889|OTHER||Odds Ratio (OR)|6.08||||0|TWO_SIDED|95.0|2.73|13.57||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||13.57|2.73|0.0000
91641730|NCT05182840|183174889|OTHER||Odds Ratio (OR)|3.58||||0.0007|TWO_SIDED|95.0|1.71|7.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.52|1.71|0.0007
91641731|NCT05182840|183174890|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
91641732|NCT05182840|183174890|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
91641733|NCT05182840|183174890|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
91641734|NCT05182840|183174891|OTHER||Odds Ratio (OR)|2.17||||0.0342|TWO_SIDED|95.0|1.06|4.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.44|1.06|0.0342
91641735|NCT05182840|183174891|OTHER||Odds Ratio (OR)|4.23||||0.0003|TWO_SIDED|95.0|1.93|9.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.24|1.93|0.0003
91716923|NCT04210986|183326180|SUPERIORITY||Contrast of LS Means|-6.9|||>|0.99|TWO_SIDED|95.0|-45.5|31.7||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||31.7|-45.5|>0.99
91716924|NCT04210986|183326181|SUPERIORITY||Contrast of LS Means|10.5||||0.748|TWO_SIDED|95.0|-12.9|33.9||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||33.9|-12.9|0.7480
91716925|NCT04210986|183326181|SUPERIORITY||Contrast of LS Means|-0.6||||0.9572|TWO_SIDED|95.0|-22.2|21.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||21.1|-22.2|0.9572
91716926|NCT04210986|183326182|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.47|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.47|>0.99
91716927|NCT04210986|183326182|SUPERIORITY||Contrast of LS Means|0.07|||>|0.99|TWO_SIDED|95.0|-0.33|0.47||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.47|-0.33|>0.99
91716928|NCT04210986|183326183|SUPERIORITY||Contrast of LS Means|-0.37|||>|0.99|TWO_SIDED|95.0|-1.61|0.87||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.87|-1.61|>0.99
91716929|NCT04210986|183326183|SUPERIORITY||Contrast of LS Means|0.16|||>|0.99|TWO_SIDED|95.0|-0.8|1.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.13|-0.80|>0.99
91716930|NCT04210986|183326184|SUPERIORITY||Contrast of LS Means|-0.022||||0.13|TWO_SIDED|95.0|-0.045|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.045|0.130
91716931|NCT04210986|183326184|SUPERIORITY||Contrast of LS Means|-0.024||||0.13|TWO_SIDED|95.0|-0.049|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.049|0.130
91485880|NCT00734474|182845093|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.81|-0.48||Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.|ANCOVA|||||-0.48|-0.81|<0.001
91485881|NCT00734474|182845093|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.50|-0.84|<0.001
91716932|NCT04210986|183326185|SUPERIORITY||Contrast of LS Means|-0.22||||0.9584|TWO_SIDED|95.0|-0.84|0.4||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.40|-0.84|0.9584
91674911|NCT00518882|183243719|SUPERIORITY_OR_OTHER||Mean|0.01|STANDARD_DEVIATION|0.272||0.5499||95.0|-0.028|0.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.052|-0.028|0.5499
91674912|NCT00518882|183243720|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|0.273|<|0.0001||95.0|-0.14|-0.062|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.062|-0.140|<0.0001
91674913|NCT00518882|183243720|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.302||0.0012||95.0|-0.118|-0.03|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.030|-0.118|0.0012
91674914|NCT00518882|183243721|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.02||||0.1119||95.0|-0.05|0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.01|-0.05|0.1119
91674915|NCT00518882|183243722|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.168||0.1342||95.0|-0.041|0.006|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.006|-0.041|0.1342
91674916|NCT00518882|183243722|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.189||0.0344||95.0|-0.057|-0.002|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.002|-0.057|0.0344
91674917|NCT00518882|183243723|SUPERIORITY_OR_OTHER||Mean|-0.08|STANDARD_DEVIATION|0.176|<|0.0001||95.0|-0.105|-0.056|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.056|-0.105|<0.0001
91674918|NCT00518882|183243723|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.192|<|0.0001||95.0|-0.094|-0.038|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.038|-0.094|<0.0001
91674919|NCT04740931|183243726|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.6|-2.5|
91674920|NCT04740931|183243726|SUPERIORITY||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6715|TWO_SIDED|95.0|-2.5|1.6||Tested at a two-sided p\<0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).||1.6|-2.5|0.6715
91674921|NCT04740931|183243728|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-8.4|5.3||||||||5.3|-8.4|
91674922|NCT04740931|183243744|OTHER||Difference in Adjusted Means|-1.2|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.7|0.3||||||||0.3|-2.7|
91674923|NCT02696031|183243779|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0197|TWO_SIDED|95.0|1.09|2.7||unadjusted p-value|Regression, Logistic|||week 16||2.70|1.09|0.0197
91674924|NCT02696031|183243779|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0146|TWO_SIDED|95.0|1.12|2.76||unadjusted p-value|Regression, Logistic|||week 16||2.76|1.12|0.0146
91674925|NCT02696031|183243780|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0017|TWO_SIDED|95.0|1.35|3.63||unadjusted p-value|Regression, Logistic|||week 52||3.63|1.35|0.0017
91674926|NCT02696031|183243780|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.36||unadjusted p-value|Regression, Logistic|||week 52||4.36|1.64|<.0001
91674927|NCT02696031|183243781|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0108|TWO_SIDED|95.0|1.14|2.74||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.74|1.14|0.0108
91674928|NCT02696031|183243781|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0087|TWO_SIDED|95.0|1.16|2.78||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.78|1.16|0.0087
91674929|NCT02696031|183243781|SUPERIORITY|week 52|Odds Ratio (OR)|2.16||||0.0016|TWO_SIDED|95.0|1.34|3.49||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|3.49|1.34|0.0016
91485882|NCT00734474|182845093|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate controlled by applying gatekeeping strategy.|LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.22|-0.56|<0.001
91641736|NCT05182840|183174891|OTHER||Odds Ratio (OR)|3.19||||0.0023|TWO_SIDED|95.0|1.52|6.73||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.73|1.52|0.0023
91641737|NCT05182840|183174892|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
91485883|NCT00734474|182845093|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.50|-0.84|<0.001
91641738|NCT05182840|183174892|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
91641739|NCT05182840|183174892|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
91641740|NCT05182840|183174893|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
91641741|NCT05182840|183174893|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
91641742|NCT05182840|183174893|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
91641743|NCT04242498|183174895|SUPERIORITY||Odds Ratio (OR)|2.422||||0.004|TWO_SIDED|97.5|1.221|4.804|||Regression, Logistic|||||4.804|1.221|0.004
91641744|NCT04242498|183174895|SUPERIORITY||Odds Ratio (OR)|2.287||||0.003|TWO_SIDED|97.5|1.22|4.291|||Regression, Logistic|||||4.291|1.220|0.003
91641745|NCT04242498|183174896|SUPERIORITY||Odds Ratio (OR)|2.722||||0.007|TWO_SIDED|97.5|1.182|6.267|||Regression, Logistic|||||6.267|1.182|0.007
91641746|NCT04242498|183174896|SUPERIORITY||Odds Ratio (OR)|3.007||||0.002|TWO_SIDED|97.5|1.374|6.581|||Regression, Logistic|||||6.581|1.374|0.002
91641747|NCT04242498|183174897|SUPERIORITY||Odds Ratio (OR)|0.798||||0.497|TWO_SIDED|97.5|0.378|1.683|||Regression, Logistic|||||1.683|0.378|0.497
91641748|NCT04242498|183174897|SUPERIORITY||Odds Ratio (OR)|1.05||||0.868|TWO_SIDED|97.5|0.541|2.041|||Regression, Logistic|||||2.041|0.541|0.868
91674930|NCT02696031|183243781|SUPERIORITY|week 52|Median Difference (Net)|2.61|||<|0.0001|TWO_SIDED|95.0|1.62|4.19||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|4.19|1.62|<.0001
91485884|NCT00734474|182845093|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.22|-0.56|<0.001
91485885|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.27|-1.51|||Mixed Models Analysis|Comparison at 26 weeks.||||-1.51|-2.27|<0.001
91485886|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|||<|0.001|TWO_SIDED|95.0|-1.85|-1.1||Comparison at 26 weeks.|Mixed Models Analysis|||||-1.10|-1.85|<0.001
91674931|NCT02696031|183243782|SUPERIORITY||Odds Ratio (OR)|1.6||||0.026|TWO_SIDED|95.0|1.06|2.43||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.43|1.06|0.0260
91674932|NCT02696031|183243782|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0149|TWO_SIDED|95.0|1.11|2.54||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.54|1.11|0.0149
91674933|NCT02696031|183243783|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0005|TWO_SIDED|95.0|1.43|3.58||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|3.58|1.43|0.0005
91485887|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.012|TWO_SIDED|95.0|-0.86|-0.11||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.11|-0.86|0.012
91641749|NCT04242498|183174898|SUPERIORITY||LS mean difference|-2.393|||<|0.001|TWO_SIDED|97.5|-3.92|-0.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.867|-3.920|<0.001
91485888|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.47|||<|0.001|TWO_SIDED|95.0|-1.82|-1.13||Comparison at 52 weeks.|Mixed Models Analysis|||||-1.13|-1.82|<0.001
91485889|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-1.07|-0.39||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.39|-1.07|<0.001
91485890|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.51|||<|0.001|TWO_SIDED|95.0|-1.93|-1.1||Comparison at 104 weeks.|Mixed Models Analysis|||||-1.10|-1.93|<0.001
91485891|NCT00734474|182845095|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.33|-0.51||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.51|-1.33|<0.001
91485892|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|18.51||||0.095|TWO_SIDED|95.0|-3.25|40.28||Comparison at 26 weeks.|Mixed Models Analysis|||||40.28|-3.25|0.095
91485893|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|17.08||||0.121|TWO_SIDED|95.0|-4.54|38.69||Comparison at 26 weeks.|Mixed Models Analysis|||||38.69|-4.54|0.121
91641750|NCT04242498|183174898|SUPERIORITY||LS mean difference|-2.309|||<|0.001||97.5|-3.705|-0.914||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.914|-3.705|<0.001
91641751|NCT04242498|183174899|SUPERIORITY||LS mean difference|-0.898||||0.01|TWO_SIDED|97.5|-1.684|-0.113||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.113|-1.684|0.010
91641752|NCT04242498|183174899|SUPERIORITY||LS mean difference|-1.265|||<|0.001|TWO_SIDED|97.5|-1.978|-0.552||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.552|-1.978|<0.001
91641753|NCT04242498|183174900|SUPERIORITY||Odds Ratio (OR)|3.273||||0.028|TWO_SIDED|97.5|0.974|10.997||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||10.997|0.974|0.028
91641754|NCT04242498|183174900|SUPERIORITY||Odds Ratio (OR)|3.756||||0.01|TWO_SIDED|97.5|1.189|11.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||11.867|1.189|0.010
91641755|NCT00931515|183174926|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91641756|NCT01375491|183174992|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||See published paper.|ANOVA|See published paper.||See published paper.||||<0.05
91641757|NCT02985541|183174996|OTHER||3-year probability of getting pregnant|0.68|||||TWO_SIDED|95.0|0.17|2.71||||||Cumulative failure rate (Kaplan-Meier) during Years 6-8||2.71|0.17|
91641758|NCT02383966|183175002|OTHER||Hazard Ratio (HR)|0.566|||||TWO_SIDED|95.0|0.4|0.803||||||||0.803|0.400|
91641759|NCT02383966|183175003|OTHER||Hazard Ratio (HR)|0.568|||||TWO_SIDED|95.0|0.406|0.795||||||||0.795|0.406|
91641760|NCT02383966|183175004|OTHER||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.502|0.991||||||||0.991|0.502|
91641761|NCT02383966|183175005|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED|95.0|1.52|5.45||||||||5.45|1.52|
91641762|NCT02383966|183175006|OTHER||Odds Ratio (OR)|2.14|||||TWO_SIDED|95.0|1.15|3.95||||||||3.95|1.15|
91641763|NCT04888377|183175012|NON_INFERIORITY|The primary hypothesis of non-inferiority was tested by calculating the mean difference between treatment arms and its associated 90% confidence interval for the primary outcome. If the lower bound of the 90% confidence interval was greater than -4, then LDA was assumed to be non-inferior to placebo. If non-inferiority were assumed, a one-sided t-test would test the benefit of LDA compared to placebo. All models controlled for site as the original randomization stratification factor.|Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.2|0.6||For each outcome, the adjusted mean difference between treatment groups and the associated 95% confidence interval based on an ANCOVA model is presented.|ANCOVA||Mean difference is Aspirin-Placebo.|Assuming a non-inferiority margin of 4 points in the BSID-III cognitive score as clinically significant, and a true effect of LDA of not more than a 1 point decrease, a total sample size of 620 was determined to provide 80% power for a one-sided test for non-inferiority with a type I error of 5%. To test this secondary hypothesis, the sample size also provided over 90% power, at a two-sided type I error of 5%, to detect a difference of 4 points between LDA and placebo based on a two-sided test.||0.6|-2.2|0.25
91716933|NCT04210986|183326185|SUPERIORITY||Contrast of LS Means|0.12||||0.9584|TWO_SIDED|95.0|-0.69|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.69|0.9584
91716934|NCT04210986|183326186|SUPERIORITY||Contrast of LS Means|1.88||||0.5905|TWO_SIDED|95.0|-5.07|8.84||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||8.84|-5.07|0.5905
91716935|NCT04210986|183326186|SUPERIORITY||Contrast of LS Means|3.86||||0.5414|TWO_SIDED|95.0|-3.08|10.79||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||10.79|-3.08|0.5414
91716936|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.05|||>|0.99|TWO_SIDED|95.0|-0.75|0.85||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 3 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.85|-0.75|>0.99
91485894|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|15.41||||0.167|TWO_SIDED|95.0|-6.47|37.29||Comparison at 26 weeks.|Mixed Models Analysis|||||37.29|-6.47|0.167
91641764|NCT00526162|183175031|OTHER||percentage|0.0|||<|0.03|ONE_SIDED|97.0||||Using a confidence interval of 97%, the exact binomial upper confidence bound was 9.5% which is lower than the 10% set for the primary safety objective. Therefore, the actual p-value has not been calculated further.|One proportion binomial exact||The confidence interval was calculated based on 35 patients who completed 1-month follow-up at interim analysis.|||||<0.03
91674934|NCT02696031|183243783|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0094|TWO_SIDED|95.0|1.16|2.94||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|2.94|1.16|0.0094
91674935|NCT02696031|183243784|SUPERIORITY||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|1.95|7.39||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.39|1.95|<.0001
91674936|NCT02696031|183243784|SUPERIORITY||Odds Ratio (OR)|3.64||||0.0001|TWO_SIDED|95.0|1.87|7.1||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.10|1.87|0.0001
91674937|NCT02696031|183243785|SUPERIORITY||LS Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.259||0.0041|TWO_SIDED|95.0|-1.26|-0.24||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.24|-1.26|0.0041
91674938|NCT02696031|183243785|SUPERIORITY||LS Mean|-0.64|STANDARD_ERROR_OF_MEAN|0.259||0.0143|TWO_SIDED|95.0|-1.15|-0.13||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.13|-1.15|0.0143
91674939|NCT02696031|183243786|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.58|4.07||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|4.07|1.58|0.0001
91716937|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.44|||>|0.99|TWO_SIDED|95.0|-0.45|1.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.34|-0.45|>0.99
91485895|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|6.38||||0.43|TWO_SIDED|95.0|-9.49|22.26||Comparison at 52 weeks.|Mixed Models Analysis|||||22.26|-9.49|0.430
91674940|NCT02696031|183243786|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.51|3.89||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.89|1.51|0.0002
91485896|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|8.77||||0.273|TWO_SIDED|95.0|-6.94|24.47||Comparison at 52 weeks.|Mixed Models Analysis|||||24.47|-6.94|0.273
91485897|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|11.07||||0.291|TWO_SIDED|95.0|-9.49|31.64||Comparison at 104 weeks.|Mixed Models Analysis|||||31.64|-9.49|0.291
91674941|NCT02696031|183243786|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0056|TWO_SIDED|95.0|1.22|3.24||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.24|1.22|0.0056
91674942|NCT02696031|183243786|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0005|TWO_SIDED|95.0|1.45|3.78||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.78|1.45|0.0005
91674943|NCT02696031|183243787|SUPERIORITY||LS Mean of treatment difference|-0.89|STANDARD_ERROR_OF_MEAN|0.256||0.0006|TWO_SIDED|95.0|-1.39|-0.38||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.38|-1.39|0.0006
91674944|NCT02696031|183243787|SUPERIORITY||LS Mean of Treatment Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.255||0.0002|TWO_SIDED|95.0|-1.47|-0.47||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.47|-1.47|0.0002
91674945|NCT02696031|183243788|SUPERIORITY||LS Mean|-1.61|STANDARD_ERROR_OF_MEAN|0.478||0.0008|TWO_SIDED|95.0|-2.54|-0.67||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.67|-2.54|0.0008
91674946|NCT02696031|183243788|SUPERIORITY||LS Mean|-1.78|STANDARD_ERROR_OF_MEAN|0.479||0.0002|TWO_SIDED|95.0|-2.72|-0.84||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.84|-2.72|0.0002
91674947|NCT02696031|183243789|SUPERIORITY|||||||0.0012||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||0.0012
91674948|NCT02696031|183243789|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
91674949|NCT02696031|183243790|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0577|TWO_SIDED|95.0|0.98|3.45||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|3.45|0.98|0.0577
91674950|NCT02696031|183243790|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0003|TWO_SIDED|95.0|1.65|5.41||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|5.41|1.65|0.0003
91485898|NCT00734474|182845096|SUPERIORITY_OR_OTHER||LS Mean Difference|21.28||||0.039|TWO_SIDED|95.0|1.03|41.53||Comparison at 104 weeks.|Mixed Models Analysis|||||41.53|1.03|0.039
91641765|NCT05279807|183175036|SUPERIORITY||Mean difference pre vs post treatment|-13.5|||<|0.001|TWO_SIDED|95.0|-14.5|-12.5|||Paired Samples T-Test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-12.5|-14.5|< 0.001
91641766|NCT01169259|183175037|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.88|1.06|||Regression, Cox|||||1.06|0.88|0.47
91641767|NCT01169259|183175037|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.13|||Regression, Cox|||||1.13|0.93|0.56
91641768|NCT01169259|183175038|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.69|TWO_SIDED|95.0|0.85|1.12|||Regression, Cox|||||1.12|0.85|0.69
91674951|NCT02696031|183243791|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance|0.84|0.58|0.0002
91485899|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.27|-1.14||Comparison at 26 weeks.|ANCOVA|||||-1.14|-2.27|<0.001
91674952|NCT02696031|183243791|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002||95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance structure.|0.84|0.58|0.0002
91674953|NCT02696031|183243792|SUPERIORITY||LS Mean of Treatment Difference|2.77|STANDARD_ERROR_OF_MEAN|0.799||0.0006|TWO_SIDED|95.0|1.2|4.34||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.34|1.20|0.0006
91674954|NCT02696031|183243792|SUPERIORITY||LS Mean of Treatment Difference|2.64|STANDARD_ERROR_OF_MEAN|0.803||0.0011|TWO_SIDED|95.0|1.06|4.22||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.22|1.06|0.0011
91674955|NCT02696031|183243793|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
91674956|NCT02696031|183243793|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
91674957|NCT02696031|183243794|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
91674958|NCT02696031|183243794|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
91485900|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.16|||<|0.001|TWO_SIDED|95.0|-1.73|-0.6||Comparison at 26 weeks.|ANCOVA|||||-0.60|-1.73|<0.001
91641769|NCT01169259|183175038|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.24|TWO_SIDED|95.0|0.8|1.06|||Regression, Cox|||||1.06|0.80|0.24
91485901|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.953|TWO_SIDED|95.0|-0.54|0.58||Comparison at 26 weeks.|ANCOVA|||||0.58|-0.54|0.953
91641770|NCT01169259|183175039|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.08|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox|||||1.02|0.67|0.08
91641771|NCT01169259|183175039|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.79|TWO_SIDED|95.0|0.79|1.2|||Regression, Cox|||||1.20|0.79|0.79
91641772|NCT01169259|183175040|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Regression, Cox|||||1.31|0.79|0.90
91641773|NCT01169259|183175040|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||||1.16|0.70|0.43
91641774|NCT01169259|183175041|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.19|TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|||||1.07|0.72|0.19
91641775|NCT01169259|183175041|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.17|TWO_SIDED|95.0|0.94|1.39|||Regression, Cox|||||1.39|0.94|0.17
91641776|NCT01169259|183175042|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.67|TWO_SIDED|95.0|0.73|1.62|||Regression, Cox|||||1.62|0.73|0.67
91641777|NCT01169259|183175042|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.31|TWO_SIDED|95.0|0.83|1.83|||Regression, Cox|||||1.83|0.83|0.31
91641778|NCT01169259|183175043|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.53|TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|||||1.08|0.86|0.53
91641779|NCT01169259|183175043|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21|TWO_SIDED|95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.21
91641780|NCT01169259|183175044|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|||||1.19|0.78|0.73
91641781|NCT01169259|183175044|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|||||0.90|0.59|0.003
91641782|NCT01169259|183175045|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox|||||1.20|0.76|0.68
91674959|NCT00063882|183243796|SUPERIORITY||Cox Proportional Hazard|0.82||||0.21|TWO_SIDED|95.0|0.6|1.12||One-sided significance level of 0.025|Greenwood's T||Reference level = Brachytherapy only|Target sample size was 586; 532 patients were needed to test hypothesis of better FFP in the EBRT + Brachytherapy arm over the Brachytherapy Only arm. The trial is designed to detect a 10% improvement in 5-year FFP with 90% power, 1-sided alpha of 0.025. The Z-test statistic for the difference between the 2 5-year FFP rates with the standard errors estimated by Greenwood's method will be used.||1.12|0.60|0.21
91674960|NCT00063882|183243797|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.63|1.54||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.54|0.63|0.95
91674961|NCT00063882|183243798|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.64|1.58||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.58|0.64|0.97
91641783|NCT01169259|183175045|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.72|TWO_SIDED|95.0|0.83|1.31|||Regression, Cox|||||1.31|0.83|0.72
91674962|NCT00063882|183243799|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.77|TWO_SIDED|95.0|0.36|3.9||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.90|0.36|0.77
91674963|NCT00063882|183243800|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.13|0.33|0.99
91641784|NCT01169259|183175046|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.38|TWO_SIDED|95.0|0.88|1.4|||Regression, Cox|||||1.40|0.88|0.38
91641785|NCT01169259|183175046|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|||||1.21|0.76|0.73
91641786|NCT01169259|183175047|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.87|TWO_SIDED|95.0|0.87|1.12|||Regression, Cox|||||1.12|0.87|0.87
91674964|NCT00063882|183243801|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.81|TWO_SIDED|95.0|0.46|2.76||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||2.76|0.46|0.81
91674965|NCT00063882|183243802|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.22|TWO_SIDED|95.0|0.51|1.17||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.17|0.51|0.22
91674966|NCT00063882|183243803|SUPERIORITY||Odds Ratio (OR)|1.13||||0.53|TWO_SIDED|95.0|0.76|1.67||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ GU/GI||1.67|0.76|0.53
91674967|NCT00063882|183243803|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.73|1.53||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ Overall||1.53|0.73|0.73
91641787|NCT01169259|183175047|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.79|TWO_SIDED|95.0|0.9|1.15|||Regression, Cox|||||1.15|0.90|0.79
91641788|NCT01169259|183175048|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.33|TWO_SIDED|95.0|0.83|1.06|||Regression, Cox|||||1.06|0.83|0.33
91674968|NCT00063882|183243803|SUPERIORITY||Odds Ratio (OR)|1.09||||0.81|TWO_SIDED|95.0|0.54|2.19||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ GU/GI||2.19|0.54|0.81
91674969|NCT00063882|183243803|SUPERIORITY||Odds Ratio (OR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.69||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ Overall||1.69|0.51|0.82
91641789|NCT01169259|183175048|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.056|TWO_SIDED|95.0|1.0|1.28|||Regression, Cox|||||1.28|1.00|0.056
91641790|NCT01169259|183175049|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.38|TWO_SIDED|95.0|0.79|1.09|||Regression, Cox|||||1.09|0.79|0.38
91641791|NCT01169259|183175049|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.18|TWO_SIDED|95.0|0.76|1.05|||Regression, Cox|||||1.05|0.76|0.18
91641792|NCT01169259|183175050|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Regression, Cox|||||0.96|0.59|0.024
91641793|NCT01169259|183175050|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.58|TWO_SIDED|95.0|0.73|1.19|||Regression, Cox|||||1.19|0.73|0.58
91641794|NCT01169259|183175051|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.62|TWO_SIDED|95.0|0.84|1.11|||Regression, Cox|||||1.11|0.84|0.62
91641795|NCT01169259|183175051|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|95.0|0.84|1.12|||Regression, Cox|||||1.12|0.84|0.72
91641796|NCT01169259|183175052|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.78|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|||||1.19|0.79|0.78
91641797|NCT01169259|183175052|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.016|TWO_SIDED|95.0|0.63|0.95|||Regression, Cox|||||0.95|0.63|0.016
91641798|NCT01169259|183175053|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.058|TWO_SIDED|95.0|0.55|1.01|||Regression, Cox|||||1.01|0.55|0.058
91641799|NCT01169259|183175053|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.73|1.33|||Regression, Cox|||||1.33|0.73|0.94
91641800|NCT01169259|183175054|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||||1.12|0.83|0.61
91485902|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|||<|0.001|TWO_SIDED|95.0|-2.08|-0.92||Comparison at 52 weeks.|ANCOVA|||||-0.92|-2.08|<0.001
91485903|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.65|-0.48||Comparison at 52 weeks.|ANCOVA|||||-0.48|-1.65|<0.001
91485904|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.14|||<|0.001|TWO_SIDED|95.0|-1.78|-0.49||Comparison at 104 weeks.|ANCOVA|||||-0.49|-1.78|<0.001
91485905|NCT00734474|182845098|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64||||0.054|TWO_SIDED|95.0|-1.29|0.01||Comparison at 104 weeks.|ANCOVA|||||0.01|-1.29|0.054
91485906|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.001|TWO_SIDED|95.0|-2.45|-0.93||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.93|-2.45|<0.001
91485907|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.133|TWO_SIDED|95.0|-1.34|0.18||Comparison at 26 weeks.|Mixed Models Analysis|||||0.18|-1.34|0.133
91674970|NCT00063882|183243804|SUPERIORITY||Hazard Ratio (HR)|2.37||||0.01|TWO_SIDED|95.0|1.2|4.68||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ GU/GI||4.68|1.20|0.01
91674971|NCT00063882|183243804|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.029|TWO_SIDED|95.0|1.06|3.1||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ Overall||3.10|1.06|0.029
91674972|NCT00063882|183243805|SUPERIORITY||Effect size|0.4|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||<0.0001
91485908|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.512|TWO_SIDED|95.0|-1.01|0.5||Comparison at 26 weeks.|Mixed Models Analysis|||||0.50|-1.01|0.512
91485909|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.69|-2.23|<0.001
91526556|NCT01225822|182928305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
91641801|NCT01169259|183175054|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.71|0.97|||Regression, Cox|||||0.97|0.71|0.016
91641802|NCT01169259|183175055|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.61|TWO_SIDED|95.0|0.83|1.39|||Regression, Cox|||||1.39|0.83|0.61
91641803|NCT01169259|183175055|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.74|1.24|||Regression, Cox|||||1.24|0.74|0.74
91641804|NCT01169259|183175056|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.37|TWO_SIDED|95.0|0.42|1.38|||Regression, Cox|||||1.38|0.42|0.37
91641805|NCT01169259|183175056|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.39|||Regression, Cox|||||2.39|0.72|0.37
91641806|NCT01169259|183175057|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.15|TWO_SIDED|95.0|0.84|3.06|||Regression, Cox|||||3.06|0.84|0.15
91641807|NCT01169259|183175057|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.04|TWO_SIDED|95.0|0.26|0.97|||Regression, Cox|||||0.97|0.26|0.04
91641808|NCT01169259|183175058|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.27|TWO_SIDED|95.0|0.83|1.95|||Regression, Cox|||||1.95|0.83|0.27
91641809|NCT01169259|183175058|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.198|TWO_SIDED|95.0|0.49|1.16|||Regression, Cox|||||1.16|0.49|0.198
91674973|NCT00063882|183243805|SUPERIORITY||Effect size|0.09||||0.33|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary- Incontinence||||0.33
91674974|NCT00063882|183243805|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
91674975|NCT00063882|183243805|SUPERIORITY||Effect size|0.31||||0.001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||0.001
91674976|NCT00063882|183243805|SUPERIORITY||Effect size|0.12||||0.23|TWO_SIDED||||||t-test, 2 sided|||Sexual|Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|||0.23
91674977|NCT00063882|183243806|SUPERIORITY||Effect size|0.38||||0.0002|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||0.0002
91674978|NCT00063882|183243806|SUPERIORITY||Effect size|0.08||||0.42|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Incontinence||||0.42
91674979|NCT00063882|183243806|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
91485910|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.128|TWO_SIDED|95.0|-1.36|0.17||Comparison at 52 weeks.|Mixed Models Analysis|||||0.17|-1.36|0.128
91485911|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.005|TWO_SIDED|95.0|-2.3|-0.42||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.42|-2.30|0.005
91485912|NCT00734474|182845100|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.256|TWO_SIDED|95.0|-1.48|0.4||Comparison at 104 weeks.|Mixed Models Analysis|||||0.40|-1.48|0.256
91526557|NCT01225822|182928305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
91641810|NCT01169259|183175059|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.58|TWO_SIDED|95.0|0.46|1.54|||Regression, Cox|||||1.54|0.46|0.58
91641811|NCT01169259|183175059|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Regression, Cox|||||2.01|0.60|0.76
91641812|NCT01169259|183175060|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.56|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.56
91674980|NCT00063882|183243806|SUPERIORITY||Effect size|0.42|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||<0.0001
91674981|NCT00063882|183243806|SUPERIORITY||Effect size|0.27||||0.0072|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Sexual||||0.0072
91485913|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.3|||<|0.001|TWO_SIDED|95.0|6.8|18.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||18.8|6.8|<0.001
91526558|NCT01225822|182928305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
91526559|NCT01225822|182928305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
91526560|NCT01225822|182928305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
91641813|NCT01169259|183175060|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.014|TWO_SIDED|95.0|0.55|0.93|||Regression, Cox|||||0.93|0.55|0.014
91641814|NCT01169259|183175061|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.92|1.27||||||||1.27|0.92|
91485914|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.6|||<|0.001|TWO_SIDED|95.0|5.2|14.3||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||14.3|5.2|<0.001
91485915|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||4.8|1.8|<0.001
91485916|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.7|5.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||5.9|2.7|<0.001
91485917|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|3.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||3.9|1.8|<0.001
91485918|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|2.4|5.0||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||5.0|2.4|<0.001
91485919|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|3.3||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||3.3|1.6|<0.001
91485920|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.5|||<|0.001|TWO_SIDED|95.0|6.5|20.4||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||20.4|6.5|<0.001
91485921|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.001|TWO_SIDED|95.0|2.8|8.8||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||8.8|2.8|<0.001
91485922|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.005|TWO_SIDED|95.0|1.3|4.1||Comparison of HbA1c ≤6.5 at 26 weeks.|Regression, Logistic|||||4.1|1.3|0.005
91526561|NCT01225822|182928306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.334||||0.0373||95.0|0.199|0.938|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.938|0.199|0.0373
91641815|NCT01169259|183175061|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.83|1.15||||||||1.15|0.83|
91641816|NCT01169259|183175062|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.82|1.26||||||||1.26|0.82|
91641817|NCT01169259|183175062|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
91641818|NCT05299359|183175063|NON_INFERIORITY|If the lower limit of the 95% CI is \>= 0.67, then the immune response to a single heterologous booster vaccination of TAK-019 is considered to be non-inferior of that to the primary series of TAK-019.|LS Mean Difference|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||GMT ratio was calculated GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.||1.47|0.95|
91641819|NCT04242446|183175102|SUPERIORITY||Odds Ratio (OR)|2.0||||0.03|TWO_SIDED|97.5|0.979|4.089|||Regression, Logistic|||||4.089|0.979|0.030
91641820|NCT04242446|183175102|SUPERIORITY||Odds Ratio (OR)|2.234||||0.006|TWO_SIDED|97.5|1.159|4.307|||Regression, Logistic|||||4.307|1.159|0.006
91641821|NCT04242446|183175103|SUPERIORITY||Odds Ratio (OR)|1.416||||0.35|TWO_SIDED|97.5|0.615|3.26||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||3.260|0.615|0.350
91485923|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||6.8|2.9|<0.001
91674982|NCT00703508|183243897|SUPERIORITY_OR_OTHER|||||||0.0234||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0234
91485924|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||3.5|1.5|<0.001
91641822|NCT04242446|183175103|SUPERIORITY||Odds Ratio (OR)|2.175||||0.021|TWO_SIDED|97.5|1.021|4.635|||Regression, Logistic|||||4.635|1.021|0.021
91485925|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||<|0.001|TWO_SIDED|95.0|3.4|7.9||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||7.9|3.4|<0.001
91485926|NCT00734474|182845101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.5|3.7||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||3.7|1.5|<0.001
91485927|NCT02899299|182845129|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.002|TWO_SIDED|96.6|0.6|0.91||Boundary for statistical significance was a p-value \< 0.0345|Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.91|0.60|0.0020
91641823|NCT04242446|183175104|SUPERIORITY||LS mean difference|-2.574||||0.002|TWO_SIDED|97.5|-4.472|-0.675||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||-0.675|-4.472|0.002
91641824|NCT04242446|183175104|SUPERIORITY||LS mean difference|-2.682|||<|0.001|TWO_SIDED|97.5|-4.394|-0.97|||ANCOVA|||||-0.970|-4.394|<0.001
91641825|NCT04242446|183175105|SUPERIORITY||LS mean difference|-0.551||||0.201|TWO_SIDED|97.5|-1.521|0.418||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||0.418|-1.521|0.201
91641826|NCT04242446|183175105|SUPERIORITY||LS mean difference|-1.186||||0.002|TWO_SIDED|97.5|-2.05|-0.322|||ANCOVA|||||-0.322|-2.050|0.002
91641827|NCT04242446|183175106|SUPERIORITY||Odds Ratio (OR)|1.618||||0.367|TWO_SIDED|97.5|0.489|5.352||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||5.352|0.489|0.367
91641828|NCT04242446|183175106|SUPERIORITY||Odds Ratio (OR)|2.757||||0.041|TWO_SIDED|97.5|0.909|8.364|||Regression, Logistic|||||8.364|0.909|0.041
91641829|NCT05644756|183175160|OTHER|The primary analysis examined changes in measurement-based care (MBC) collection over time using ANOVA. The study was not designed as a superiority, non-inferiority, or equivalence trial.|||||>|0.01|||||||ANOVA|||||||>.01
91641830|NCT04058990|183175184|NON_INFERIORITY|13.2% non-inferiority margin||||||0.0012|||||||Farrington-Manning|||\[Not Specified\]||||0.0012
91641831|NCT02203305|183175231|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: Interval and condition (p\<0.001).||Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
91641832|NCT02203305|183175231|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: interval and condition (p\<0.001).||Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
91641833|NCT02203305|183175231|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
91641834|NCT02203305|183175231|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
91641835|NCT02203305|183175231|SUPERIORITY||||||<|0.429||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and group (p=0.429). Interaction: group and interval (p=0.387).||Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.429
91641836|NCT02203305|183175232|SUPERIORITY||||||<|0.019||||||The Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.19) and condition (p\<0.001). Interaction: interval and condition (p\<0.019).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.019
91641837|NCT02203305|183175232|SUPERIORITY||||||<|0.012||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.012) and condition (p\<0.001). Interaction: interval and condition (p=0.004).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.012
91485928|NCT02899299|182845132|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.77|1.13|||||Stratified Cox proportional hazard model|||1.13|0.77|
91641838|NCT02203305|183175232|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
91485929|NCT02899299|182845133|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||\<1% PD-L1||1.32|0.64|
91485930|NCT02899299|182845133|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.88||||||≥1% PD-L1||0.88|0.59|
91641839|NCT02203305|183175232|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
91641840|NCT02203305|183175232|OTHER|correlation|bivariate pearson correlation|0.42|||=|0.033|TWO_SIDED||||||bivariate pearson correlation|||Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.033
91641841|NCT02203305|183175232|SUPERIORITY||||||<|0.249||||||There were significant main effects of group (p\<0.001) and interval (p\<0.001). There was a non-significant interaction between group and interval (p=0.249).|Mixed Models Analysis|Main effects: group (p\<0.001) and interval (p\<0.001). Interaction: group and interval (p=0.249).||Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.249
91641842|NCT02203305|183175233|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Speech, Spatial, \& Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
91641843|NCT02203305|183175233|SUPERIORITY||||||=|0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.056
91641844|NCT02203305|183175233|SUPERIORITY||||||<|0.448||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.488).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.448
91641845|NCT02203305|183175233|SUPERIORITY||||||<|0.299||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: subscale (p\<0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.299
91641846|NCT02203305|183175233|SUPERIORITY||||||<|0.018||||||There were significant main effects of interval (p\<0.001) and pragmatic subscale (p\<0.001), and their interaction (p\<0.018).|Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.018).||Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.018
91674983|NCT00703508|183243897|SUPERIORITY_OR_OTHER|||||||0.074||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0740
91674984|NCT00703508|183243897|SUPERIORITY_OR_OTHER|||||||0.4698||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.4698
91674985|NCT00703508|183243897|SUPERIORITY_OR_OTHER|||||||0.118||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1180
91674986|NCT00703508|183243897|SUPERIORITY_OR_OTHER|||||||0.0311||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.0311
91485931|NCT02899299|182845134|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|1.79|||||TWO_SIDED|95.0|1.22|2.63||||||\< 1% PD-L1||2.63|1.22|
91485932|NCT02899299|182845134|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||≥1% PD-L1||0.96|0.61|
91485933|NCT02899299|182845136|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.62|0.88|||Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.88|0.62|0.0008
91485934|NCT00313300|182845137|SUPERIORITY_OR_OTHER||Adjusted rate difference|2.2|||||TWO_SIDED|95.0|-1.0|5.4|||||adjusted difference of event rates takes into consideration stratification factors.|||5.4|-1.0|
91485935|NCT00313300|182845137|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|3.8|||||TWO_SIDED|95.0|0.4|7.3|||||adjusted difference of event rates takes into consideration stratification factors.|||7.3|0.4|
91485936|NCT00313300|182845138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||||1.19|0.44|
91485937|NCT00313300|182845138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.35|1.04||||||||1.04|0.35|
91526562|NCT01225822|182928306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.837||||0.6659||95.0|0.374|1.875|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.875|0.374|0.6659
91641847|NCT02203305|183175233|SUPERIORITY||||||<|0.767|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542).||Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.767
91641848|NCT02203305|183175233|SUPERIORITY||||||<|0.242|||||||Mixed Models Analysis|Main effects: interval (p=0.003) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.242).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.242
91641849|NCT02203305|183175233|OTHER|Bivariate pearson correlation||||||0.37|||||||bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||0.370
91641850|NCT02203305|183175233|OTHER|bivariate pearson correlation|||||=|0.865||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.865
91641851|NCT02203305|183175233|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.6|||=|0.005|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.005
91641852|NCT02203305|183175233|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.67|||=|0.006|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.006
91641853|NCT02203305|183175233|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.33|||=|0.152|TWO_SIDED||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.152
91641854|NCT02203305|183175233|OTHER|bivariate pearson correlation|||||=|0.761|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.761
91641855|NCT02203305|183175233|OTHER|bivariate pearson correlation|||||=|0.315|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.315
91641856|NCT02203305|183175233|OTHER|bivariate pearson correlation|||||=|0.666|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.666
91641857|NCT02203305|183175233|SUPERIORITY||||||>|0.175|||||||Mixed Models Analysis|Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p\>0.175).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.175
91641858|NCT02203305|183175234|SUPERIORITY||||||<|0.161||||||"Significant effect of interval (p=0.046) and of condition (p\<0.001) and a non-significant interaction (p=0.161).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: interval (p=0.046) and condition (p\<0.001). Interaction: interval and condition (p=0.161).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.161
91641859|NCT02203305|183175234|SUPERIORITY||||||>|0.107||||||"Significant effect of condition (p\<0.001) and the interaction (p\<0.001). Non-significant effect of interval (p=0.107).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: condition (p\<0.001) and interval p=0.107). Interaction of condition and interval (p\<0.001).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.107
91641860|NCT02203305|183175234|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
91641861|NCT02203305|183175234|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
91641862|NCT02203305|183175234|OTHER|bivariate pearson correlation|||||=|0.58||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.||||=0.580
91674987|NCT00703508|183243897|SUPERIORITY_OR_OTHER|||||||0.1586||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1586
91674988|NCT01064323|183243910|OTHER|Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)||||||0.02|||||||Paired t-test|||||||0.02
91674989|NCT01064323|183243917|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.2
91674990|NCT00486018|183243928|SUPERIORITY_OR_OTHER||Difference in Least Squares means|9.4|||<|0.0001||95.0|6.6|12.2||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||12.2|6.6|<0.0001
91674991|NCT00486018|183243928|SUPERIORITY_OR_OTHER||Difference in Least Squares means|10.6|||<|0.0001||95.0|7.6|13.6||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||13.6|7.6|<0.0001
91674992|NCT00486018|183243929|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001||95.0|15.6|38.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||38.0|15.6|<0.0001
91674993|NCT00486018|183243929|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001||95.0|20.1|42.6|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||42.6|20.1|<0.0001
91674994|NCT00486018|183243930|SUPERIORITY_OR_OTHER||Difference in percentage|4.5||||0.0141||95.0|1.6|9.9|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||9.9|1.6|0.0141
91674995|NCT00486018|183243930|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.2815||95.0|-1.5|8.3|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||8.3|-1.5|0.2815
91674996|NCT00486018|183243931|SUPERIORITY_OR_OTHER||Difference in percentage|45.5|||<|0.0001||95.0|36.0|55.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||55.0|36.0|<0.0001
91674997|NCT00486018|183243931|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001||95.0|29.9|50.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||50.2|29.9|<0.0001
91674998|NCT00486018|183243932|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-148.7|||<|0.0001||95.0|-183.6|-113.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-113.8|-183.6|<0.0001
91674999|NCT00486018|183243932|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-134.8|||<|0.0001||95.0|-172.7|-96.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-96.8|-172.7|<0.0001
91675000|NCT00486018|183243933|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0214||95.0|0.6|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||7.6|0.6|0.0214
91675001|NCT00486018|183243933|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.4||||0.0002||95.0|3.0|9.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.8|3.0|0.0002
91485938|NCT00313300|182845139|SUPERIORITY_OR_OTHER||Adjusted rate difference|6.6|||||TWO_SIDED|95.0|1.8|11.3|||||adjusted difference of event rates takes into consideration stratification factors.|||11.3|1.8|
91485939|NCT00313300|182845139|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.0|||||TWO_SIDED|95.0|4.8|15.2|||||adjusted difference of event rates takes into consideration stratification factors.|||15.2|4.8|
91675002|NCT00486018|183243934|SUPERIORITY_OR_OTHER||Difference in Least Squares means|3.8||||0.0248||95.0|0.5|7.0|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.0|0.5|0.0248
91675003|NCT00486018|183243934|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.1||||0.0014||95.0|2.0|8.3|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||8.3|2.0|0.0014
91675004|NCT01138111|183243935|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0001
91675005|NCT01138111|183243935|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0011
91675006|NCT01138111|183243935|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0008
91692170|NCT03296527|183279346|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.62||||0.02|TWO_SIDED|95.0|0.42|0.93||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor or excessive response, or transfer cancellation due to excessive response/OHSS risk||0.93|0.42|0.020
91692171|NCT03296527|183279347|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
91692172|NCT03296527|183279347|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
91692173|NCT03296527|183279347|SUPERIORITY|||||||0.568||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||0.568
91485940|NCT00313300|182845140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.44|1.17||||||||1.17|0.44|
91641863|NCT02203305|183175234|SUPERIORITY||||||<|0.743||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Effects: SNR (p=0.026) \& masker condition (p\<0.001). Interactions: cohort \& condition (p\<0.001), interval \& condition (p=0.015). Others (p\>0.140).||Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.743
91641864|NCT02203305|183175234|OTHER|pearson correlation|||||=|0.036||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||=0.036
91641865|NCT02203305|183175235|SUPERIORITY||||||<|0.183||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.183) and condition (p=0.012). Interaction: interval and condition (p=0.081).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.183
91641866|NCT02203305|183175235|SUPERIORITY||||||<|0.196||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.196
91641867|NCT02203305|183175235|SUPERIORITY|||||||0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||0.056
91675007|NCT02149121|183243950|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|97.07|||||TWO_SIDED|90.0|88.08|106.99|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using analysis of covariance (ANCOVA) model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||106.99|88.08|
91675008|NCT02149121|183243950|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.18|||||TWO_SIDED|90.0|85.4|103.86|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||103.86|85.40|
91675009|NCT02149121|183243950|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|103.07|||||TWO_SIDED|90.0|93.32|113.85|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.85|93.32|
91485941|NCT00313300|182845140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.37|1.07||||||||1.07|0.37|
91485942|NCT00313300|182845141|SUPERIORITY_OR_OTHER||Adjusted rate difference|0.3|||||TWO_SIDED|95.0|-1.3|2.0|||||adjusted difference of event rates takes into consideration stratification factors.|||2.0|-1.3|
91485943|NCT00313300|182845141|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||adjusted difference of event rates takes into consideration stratification factors.|||2.7|-1.1|
91485944|NCT00313300|182845142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
91485945|NCT00313300|182845142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
91485946|NCT00313300|182845142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
91485947|NCT00313300|182845142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
91641868|NCT02203305|183175235|SUPERIORITY||||||=|0.21||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||=0.210
91716938|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.42|||>|0.99|TWO_SIDED|95.0|-0.7|1.54||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.54|-0.70|>0.99
91716939|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.06|||>|0.99|TWO_SIDED|95.0|-0.91|0.78||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.78|-0.91|>0.99
91716940|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.47|||>|0.99|TWO_SIDED|95.0|-1.5|0.56||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 15 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.56|-1.50|>0.99
91485948|NCT00313300|182845143|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.0|||||TWO_SIDED|95.0|0.0|8.1||||||||8.1|0.0|
91485949|NCT00313300|182845143|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|0.0|9.3||||||||9.3|0.0|
91641869|NCT02203305|183175236|SUPERIORITY||||||<|0.071||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.071) and condition (p\<0.001). Interaction: interval and condition (p\<0.051)||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.071
91641870|NCT02203305|183175236|SUPERIORITY||||||<|0.109||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.109) and condition (p\<0.001). Interaction: interval and condition (p=0.052).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.109
91641871|NCT02203305|183175236|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
91641872|NCT02203305|183175236|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
91641873|NCT02203305|183175237|SUPERIORITY||||||<|0.024||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.018) and condition (p\<0.001). Interaction: interval and condition (p=0.024).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.024
91641874|NCT02203305|183175237|SUPERIORITY||||||<|0.219|||||||Mixed Models Analysis|Main effects: interval (p=0.187) and condition (p\<0.001). Interaction: interval and condition (p=0.219).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.219
91485950|NCT00313300|182845143|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|7.0|||||TWO_SIDED|95.0|3.4|10.5||||||||10.5|3.4|
91641875|NCT02203305|183175237|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
91675010|NCT02149121|183243951|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|95.81|||||TWO_SIDED|90.0|87.39|105.04|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||105.04|87.39|
91675011|NCT02149121|183243951|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.89|||||TWO_SIDED|90.0|81.85|98.72|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||98.72|81.85|
91716941|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.19|||>|0.99|TWO_SIDED|95.0|-1.16|0.77||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.77|-1.16|>0.99
91485951|NCT00313300|182845143|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|1.4|8.0||||||||8.0|1.4|
91485952|NCT00313300|182845144|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|8.3|||||TWO_SIDED|95.0|1.8|14.9||||||||14.9|1.8|
91485953|NCT00313300|182845144|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.9|||||TWO_SIDED|95.0|3.4|18.4||||||||18.4|3.4|
91641876|NCT02203305|183175237|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
91641877|NCT02203305|183175238|SUPERIORITY||||||=|0.011||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.011
91641878|NCT02203305|183175238|SUPERIORITY||||||=|0.264||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.||||=0.264
91641879|NCT02203305|183175238|SUPERIORITY||||||<|0.023||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.023
91485954|NCT00313300|182845144|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|17.4|||||TWO_SIDED|95.0|11.6|23.2||||||||23.2|11.6|
91485955|NCT00313300|182845144|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.4|||||TWO_SIDED|95.0|5.6|15.1||||||||15.1|5.6|
91641880|NCT02203305|183175238|SUPERIORITY||||||<|0.643|||||||Mixed Models Analysis|Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.643
91641881|NCT02203305|183175238|OTHER|bivariate pearson correlation (one-tailed)|||||=|0.947||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.947
91641882|NCT02203305|183175238|SUPERIORITY||||||=|0.5||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.500
91641883|NCT02203305|183175238|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.51|||=|0.023|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.023
91641884|NCT02203305|183175238|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.55|||=|0.033|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.033
91641885|NCT02203305|183175238|SUPERIORITY||||||>|0.208|||||||Mixed Models Analysis|Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p\>0.287).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.208
91641886|NCT02203305|183175239|SUPERIORITY||||||=|0.221||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.221
91641887|NCT02203305|183175239|SUPERIORITY||||||=|0.538||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.538
91641888|NCT02203305|183175239|SUPERIORITY||||||>|0.218||||||There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218).|Mixed Models Analysis|Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.218
91485956|NCT00313300|182845145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
91641889|NCT02203305|183175240|SUPERIORITY||||||<|0.322||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.084) and condition (p=0.322). Interaction: interval and condition (p=0.125).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.322
91675012|NCT02149121|183243951|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.58|||||TWO_SIDED|90.0|97.03|117.08|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||117.08|97.03|
91485957|NCT00313300|182845145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
91485958|NCT00313300|182845145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
91485959|NCT00313300|182845145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
91485960|NCT00313300|182845146|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-0.9|2.6||||||||2.6|-0.9|
91485961|NCT00313300|182845146|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|2.9|||||TWO_SIDED|95.0|0.6|5.1||||||||5.1|0.6|
91485962|NCT00313300|182845146|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.1|||||TWO_SIDED|95.0|1.3|6.9||||||||6.9|1.3|
91675013|NCT02149121|183243952|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.92|||||TWO_SIDED|90.0|89.61|100.55|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||100.55|89.61|
91675014|NCT02149121|183243952|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.0|||||TWO_SIDED|90.0|84.01|94.28|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||94.28|84.01|
91675015|NCT02149121|183243952|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.66|||||TWO_SIDED|90.0|100.56|113.13|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.13|100.56|
91675016|NCT02149121|183243953|EQUIVALENCE|Therapeutic equivalence was to be concluded if the 90% CI for the treatment difference in the change from baseline of DAS28 (CRP) at Week 24 was entirely within the equivalence margin of ±0.50.|Mean Difference (Final Values)|-0.01|||||TWO_SIDED|90.0|-0.22|0.2|||||Adjusted least squares means and standard error, estimate of treatment difference \[CT-P10 - (Rituxan + MabThera)\] and 2-sided 90% confidence interval calculated from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, study part, interaction of treatment group with study part, prior anti TNF alpha blocker status at baseline (intolerance case versus inadequate response), and RF or anti-CCP status fitted as covariates.||0.20|-0.22|
91675017|NCT02149121|183243958|OTHER||Ratio of geometric least squares means|102.37|||||TWO_SIDED|95.0|92.46|113.33||||||Secondary PD analysis were analyzed using an ANCOVA model with results as the response, treatment group, as fixed effect and baseline values, gender, region, race, study part, interaction of treatment group with study part, prior anti-TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.|Estimate of Geometric Least Square Mean and ratio of Geometric Least Square Means (CT-P10/reference products) were obtained from back transforming the least square means from the ANCOVA.|113.33|92.46|
91675018|NCT07106489|183243964|SUPERIORITY||Mean Difference (Net)|0.04||||0.8705|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.8705
91675019|NCT07106489|183243965|SUPERIORITY||Mean Difference (Net)|0.01||||0.9161|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.9161
91675020|NCT07106489|183243966|SUPERIORITY||Mean Difference (Net)|-0.15||||0.4166|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.4166
91675021|NCT07106489|183243967|SUPERIORITY||Mean Difference (Net)|0.0||||0.9995|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.9995
91675022|NCT07106489|183243968|SUPERIORITY||Mean Difference (Net)|-0.09||||0.0422|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.0422
91675023|NCT07106489|183243969|SUPERIORITY||Mean Difference (Net)|5.56||||0.0027|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.0027
91675024|NCT07106489|183243970|SUPERIORITY||Mean Difference (Net)|1.2||||0.2598|TWO_SIDED||||||t-test, 2 sided||Beetroot effect|||||0.2598
91675025|NCT07106489|183243971|SUPERIORITY||Mean Difference (Net)|-0.6||||0.1725|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Beetroot effect|||||0.1725
91675026|NCT00603291|183243972|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.14|||<|0.0001|TWO_SIDED|95.0|2.05|4.8|||Regression, Logistic|Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum||||4.80|2.05|<0.0001
91675027|NCT00603291|183243973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.06|||<|0.0001|TWO_SIDED|95.0|-3.92|-2.2|||ANCOVA|||||-2.20|-3.92|<0.0001
91692056|NCT04042467|183278709|SUPERIORITY||Estimated intervention effect at 24 mo.|-0.33|||<|0.001|TWO_SIDED|95.0|-0.57|-0.09||The p-value was not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Regression, Linear|Wald test (4 DoF) of intervention main effect and 3 intervention by age interaction parameters equal 0 vs. alternative that at least one was not 0.|The p-value is for the Wald test (4 DoF) evaluating whether the Greenlight Plus and Greenlight group trajectories were significantly different. The estimation parameter is the model-estimated intervention effect at 24 months (kg/m).|"Linear mixed-effects model (random intercepts and slopes for clinics and participants within clinics). A priori adjustment for baseline variables: child birth weight and biological sex, race/ethnicity, health literacy, language, education, income, and food insecurity. Child age and birth weight were included using natural splines with 3 DoF.~Effect evaluated using Wald test with a 2-sided, 0.05 significance level. Null hypothesis: Equal weight-for-length growth trajectories in the two groups."||-0.09|-0.57|<0.001
91692057|NCT05151744|183278713|SUPERIORITY||Difference in Adjusted Means|3.4||||0.0625|TWO_SIDED|95.0|-0.2|7.0|||MMRM|||||7.0|-0.2|0.0625
91485963|NCT03423641|182845167|SUPERIORITY||Odds Ratio (OR)|0.81||||0.68|TWO_SIDED|95.0|0.3|2.2|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||2.20|0.30|.68
91526563|NCT01225822|182928306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.1882||95.0|0.183|1.397|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.397|0.183|0.1882
91675028|NCT02177136|183243974|SUPERIORITY|||||||0.0434|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0434
91675029|NCT02177136|183243974|SUPERIORITY|||||||0.0665|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0665
91675030|NCT02054130|183243999|SUPERIORITY||Rate ratio|0.38|||<|0.001|TWO_SIDED|95.0|0.23|0.63|||Negative binomial regression|||||0.63|0.23|<0.001
91675031|NCT02054130|183243999|SUPERIORITY||Rate ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Negative binomial regression|||||0.51|0.16|<0.001
91675032|NCT02054130|183243999|SUPERIORITY||Rate ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.58|||Negative bnomial regression|||||0.58|0.20|<0.001
91675033|NCT02493777|183244052|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
91675034|NCT02493777|183244053|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
91675035|NCT00468728|183244054|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|6.8||||||H0: C(OPT-80) - C(VAN) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||6.8|-4.8|
91675036|NCT00468728|183244055|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-14.4|||<|0.001|TWO_SIDED|95.0|-21.6|-7.0|||Chi-squared|||||-7.0|-21.6|<0.001
91675037|NCT00468728|183244056|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.001||95.0|5.4|21.1|||Chi-squared|||||21.1|5.4|0.001
91675038|NCT02312713|183244154|SUPERIORITY||Mean Difference (Final Values)|-3.36||||0.06|TWO_SIDED|95.0|-6.84|0.12|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.12|-6.84|0.06
91675039|NCT02312713|183244154|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.39|TWO_SIDED|95.0|-5.26|2.08|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||2.08|-5.26|0.39
91675040|NCT02312713|183244154|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.14|TWO_SIDED|95.0|-6.24|0.85|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.85|-6.24|0.14
91675041|NCT02312713|183244154|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.17|TWO_SIDED|95.0|-6.37|1.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||1.11|-6.37|0.17
91675042|NCT02312713|183244154|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|0.67||||0.65|TWO_SIDED|95.0|-2.23|3.56|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.56|-2.23|0.65
91485964|NCT03423641|182845168|SUPERIORITY||Odds Ratio (OR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.91|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.91|0.56|0.01
91675043|NCT02312713|183244154|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|-1.04||||0.51|TWO_SIDED|95.0|-4.13|2.05|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.05|-4.13|0.51
91675044|NCT02312713|183244155|SUPERIORITY||Median Difference (Final Values)|0.56||||0.01|TWO_SIDED|95.0|0.15|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.98|0.15|0.01
91675045|NCT02312713|183244155|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.28|TWO_SIDED|95.0|-0.19|0.65|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.65|-0.19|0.28
91485965|NCT03423641|182845169|SUPERIORITY||Odds Ratio (OR)|0.92||||0.39|TWO_SIDED|95.0|0.75|1.12|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.12|0.75|0.39
91675046|NCT02312713|183244155|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.75|TWO_SIDED|95.0|-0.35|0.49|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.49|-0.35|0.75
91675047|NCT02312713|183244155|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.22|TWO_SIDED|95.0|-0.16|0.7|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.7|-0.16|0.22
91675048|NCT02312713|183244155|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.84|-0.16|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||-0.16|-0.84|0.00
91692058|NCT05151744|183278715|SUPERIORITY||Difference in Adjusted Mean|2.7||||0.2052|TWO_SIDED|95.0|-1.5|7.0|||MMRM|||||7.0|-1.5|0.2052
91485966|NCT03423641|182845170|SUPERIORITY||Odds Ratio (OR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.9|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.90|0.49|0.01
91526564|NCT01225822|182928306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.5566||95.0|0.39|1.66|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.66|0.39|0.5566
91675049|NCT02312713|183244155|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.04||||0.83|TWO_SIDED|95.0|-0.31|0.39|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.39|-0.31|0.83
91675050|NCT02312713|183244156|SUPERIORITY||Mean Difference (Final Values)|7.75||||0.04|TWO_SIDED|95.0|0.43|15.07|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.||15.07|0.43|0.04
91675051|NCT02312713|183244156|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.78|TWO_SIDED|95.0|-6.59|8.82|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.||8.82|-6.59|0.78
91675052|NCT02312713|183244156|SUPERIORITY||Mean Difference (Final Values)|4.88||||0.2|TWO_SIDED|95.0|-2.56|12.33|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.||12.33|-2.56|0.20
91675053|NCT02312713|183244156|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.78|TWO_SIDED|95.0|-6.74|8.99|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.||8.99|-6.74|.78
91675054|NCT02312713|183244156|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-2.86||||0.35|TWO_SIDED|95.0|-8.94|3.21|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.||3.21|-8.94|0.35
91675055|NCT02312713|183244156|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-6.4|6.42|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.||6.42|-6.40|1.00
91675056|NCT02312713|183244157|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.19|TWO_SIDED|95.0|-1.56|0.3|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.||0.30|-1.56|0.19
91675057|NCT02312713|183244157|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.89|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.||0.98|-0.89|0.93
91675058|NCT02312713|183244157|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.97|TWO_SIDED|95.0|-0.97|0.93|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.||0.93|-0.97|0.97
91675059|NCT02312713|183244157|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.91|1.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time||1|-0.91|0.93
91692059|NCT05151744|183278716|SUPERIORITY||Difference in Adjusted Mean|3.3||||0.0192|TWO_SIDED|95.0|0.5|6.0|||MMRM|||||6.0|0.5|0.0192
91692060|NCT05151744|183278717|SUPERIORITY||Difference in Adjusted Mean|2.5||||0.0637|TWO_SIDED|95.0|-0.1|5.2|||MMRM|||||5.2|-0.1|0.0637
91692061|NCT05151744|183278718|SUPERIORITY||Difference in Adjusted Mean|0.8||||0.7091|TWO_SIDED|95.0|-3.3|4.9|||MMRM|||||4.9|-3.3|0.7091
91692062|NCT05151744|183278719|SUPERIORITY||Difference in Adjusted Mean|1.8||||0.1107|TWO_SIDED|95.0|-0.4|4.1|||MMRM|||||4.1|-0.4|0.1107
91692063|NCT05151744|183278720|SUPERIORITY||Difference in Adjusted Mean|2.1||||0.1498|TWO_SIDED|95.0|-0.8|5.0|||MMRM|||||5.0|-0.8|0.1498
91692064|NCT05151744|183278721|SUPERIORITY||Difference in Adjusted Mean|1.8||||0.3783|TWO_SIDED|95.0|-2.3|6.0|||MMRM|||||6.0|-2.3|0.3783
91692065|NCT05151744|183278722|SUPERIORITY||Difference in Adjusted Mean|1.9||||0.1036|TWO_SIDED|95.0|-0.4|4.3|||MMRM|||||4.3|-0.4|0.1036
91692066|NCT05151744|183278729|SUPERIORITY||Difference in Adjusted Mean|-10.0||||0.4968|TWO_SIDED|95.0|-38.9|18.9|||MMRM|||||18.9|-38.9|0.4968
91692067|NCT05151744|183278730|SUPERIORITY||Difference in Adjusted Mean|-23.2||||0.3951|TWO_SIDED|95.0|-76.8|30.5|||MMRM|||||30.5|-76.8|0.3951
91692068|NCT05151744|183278731|SUPERIORITY||Difference in Adjusted Mean|-22.8||||0.0521|TWO_SIDED|95.0|-45.8|0.2|||MMRM|||||0.2|-45.8|0.0521
91692069|NCT05151744|183278732|SUPERIORITY||Difference in Adjusted Mean|-17.5||||0.2227|TWO_SIDED|95.0|-45.7|10.7|||MMRM|||||10.7|-45.7|0.2227
91692070|NCT05151744|183278733|SUPERIORITY||Difference in Adjusted Mean|-27.2||||0.2972|TWO_SIDED|95.0|-78.6|24.2|||MMRM|||||24.2|-78.6|0.2972
91675060|NCT02312713|183244157|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.61||||0.12|TWO_SIDED|95.0|-0.16|1.38|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.||1.38|-0.16|0.12
91675061|NCT02312713|183244157|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.78|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.||0.77|-0.78|1.00
91675062|NCT02312713|183244158|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.63|TWO_SIDED|95.0|-1.55|0.94|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.||.94|-1.55|0.63
91675063|NCT02312713|183244158|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.37|TWO_SIDED|95.0|-1.58|0.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.||0.6|-1.58|0.37
91675064|NCT02312713|183244158|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.62|TWO_SIDED|95.0|-0.95|1.59|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.||1.59|-0.95|0.62
91675065|NCT02312713|183244158|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.67|TWO_SIDED|95.0|-0.87|1.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.||1.35|-0.87|0.67
91675066|NCT02312713|183244158|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.63||||0.23|TWO_SIDED|95.0|-0.4|1.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.||1.66|-0.40|0.23
91675067|NCT02312713|183244158|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.74||||0.11|TWO_SIDED|95.0|-0.17|1.64|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.||1.64|-0.17|0.11
91675068|NCT02312713|183244159|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.52|TWO_SIDED|95.0|-1.58|0.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.||0.8|-1.58|0.52
91675069|NCT02312713|183244159|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.||0.85|-1.86|0.46
91675070|NCT02312713|183244159|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.3|TWO_SIDED|95.0|-1.85|0.58|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.||0.58|-1.85|0.3
91675071|NCT02312713|183244159|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.08|TWO_SIDED|95.0|-2.61|0.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.||0.16|-2.61|0.08
91675072|NCT02312713|183244159|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.24||||0.63|TWO_SIDED|95.0|-1.23|0.74|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.||0.74|-1.23|0.63
91675073|NCT02312713|183244159|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.72||||0.21|TWO_SIDED|95.0|-1.85|0.41|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.||0.41|-1.85|0.21
91675074|NCT02312713|183244160|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.05|TWO_SIDED|95.0|-1.59|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.02|-1.59|0.05
91485967|NCT03423641|182845171|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.01|TWO_SIDED|95.0|0.3|0.59|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.59|0.30|<0.01
91485968|NCT03423641|182845172|SUPERIORITY||Odds Ratio (OR)|0.68||||0.12|TWO_SIDED|95.0|0.42|1.1|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.10|0.42|0.12
91485969|NCT03423641|182845173|SUPERIORITY||Odds Ratio (OR)|0.61||||0.34|TWO_SIDED|95.0|0.22|1.7|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.70|0.22|0.34
91485970|NCT03423641|182845174|SUPERIORITY||Marginal Structural Model|0.61|||<|0.01|TWO_SIDED|95.0|0.49|0.76|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.76|0.49|<0.01
91485971|NCT03423641|182845175|SUPERIORITY||Rate Ratio|0.71|||<|0.01|TWO_SIDED|95.0|0.6|0.84|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.84|0.60|<0.01
91485972|NCT03423641|182845176|SUPERIORITY||Rate Ratio|0.82|||<|0.01|TWO_SIDED|95.0|0.77|0.87|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.87|0.77|<0.01
91485973|NCT03423641|182845177|SUPERIORITY||Odds Ratio (OR)|0.47||||0.02|TWO_SIDED|95.0|0.25|0.88|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.88|0.25|0.02
91485974|NCT03423641|182845178|SUPERIORITY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.37|1.03|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.03|0.37|0.07
91526565|NCT01225822|182928306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.674||||0.3253||95.0|0.307|1.48|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.48|0.307|0.3253
91641890|NCT02203305|183175240|SUPERIORITY||||||<|0.317||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.317
91641891|NCT02203305|183175240|SUPERIORITY||||||=|0.017||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.017
91641892|NCT02203305|183175240|SUPERIORITY||||||=|0.292||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.292
91641893|NCT02203305|183175240|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
91675075|NCT02312713|183244160|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.05|TWO_SIDED|95.0|-1.82|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.02|-1.82|0.05
91675076|NCT02312713|183244160|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.19|TWO_SIDED|95.0|-1.37|0.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.27|-1.37|0.19
91675077|NCT02312713|183244160|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.06|TWO_SIDED|95.0|-1.83|0.05|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.05|-1.83|0.06
91675078|NCT02312713|183244160|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.23||||0.49|TWO_SIDED|95.0|-0.43|0.89|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||0.89|-0.43|0.49
91675079|NCT02312713|183244160|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.77|0.78|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.78|-0.77|0.99
91675080|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.57||||0.36|TWO_SIDED|95.0|-1.77|4.92|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.||4.92|-1.77|0.36
91485975|NCT03423641|182845179|SUPERIORITY||Odds Ratio (OR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.05|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.05|0.63|0.11
91485976|NCT04540497|182845181|OTHER||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.06|0.28|||||Inebilizumab versus placebo|||0.28|0.06|
91485977|NCT04540497|182845188|OTHER||Hazard Ratio (HR)|0.12|||||TWO_SIDED|95.0|0.05|0.26|||||Inebilizumab vs placebo|||0.26|0.05|
91485978|NCT03914326|182845209|SUPERIORITY|Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.|Hazard Ratio (HR)|0.86||||0.0028|TWO_SIDED|95.0|0.77|0.96|||Regression, Cox|||||0.96|0.77|0.0028
91485979|NCT03323502|182845234|SUPERIORITY||Incidence Rate Ratio (IRR)|0.94|STANDARD_ERROR_OF_MEAN|0.061||0.3313|TWO_SIDED|95.0|0.84|1.06|||Poisson Regression|||||1.06|0.84|0.3313
91675081|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.51||||0.17|TWO_SIDED|95.0|-1.11|6.14|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.||6.14|-1.11|0.17
91675082|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.94||||0.06|TWO_SIDED|95.0|-0.19|8.06|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.||8.06|-0.19|0.06
91675083|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.14|TWO_SIDED|95.0|-1.08|7.79|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.||7.79|-1.08|0.14
91675084|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|2.37||||0.25|TWO_SIDED|95.0|-1.67|6.4|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.||6.4|-1.67|0.25
91675085|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.7|TWO_SIDED|95.0|-3.48|5.18|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.||5.18|-3.48|0.70
91675086|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-1.32||||0.4|TWO_SIDED|95.0|-4.43|1.79|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.||1.79|-4.43|0.40
91675087|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.84|TWO_SIDED|95.0|-2.93|3.59|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.||3.59|-2.93|0.84
91675088|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|2.11||||0.28|TWO_SIDED|95.0|-1.73|5.94|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.||5.94|-1.73|0.28
91716942|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.19|||>|0.99|TWO_SIDED|95.0|-0.58|0.96||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 21 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.96|-0.58|>0.99
91716943|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.76|0.97||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 24 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.97|-0.76|>0.99
91485980|NCT03323502|182845235|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3327|TWO_SIDED|95.0|0.78|1.09|||Regression, Logistic|||||1.09|0.78|0.3327
91675089|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|2.79||||0.17|TWO_SIDED|95.0|-1.2|6.77|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.||6.77|-1.2|0.17
91675090|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.43||||0.07|TWO_SIDED|95.0|-0.32|7.18|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.||7.18|-0.32|0.07
91675091|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.22|TWO_SIDED|95.0|-1.44|6.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.||6.34|-1.44|0.22
91675092|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.21||||0.92|TWO_SIDED|95.0|-4.47|4.06|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.||4.06|-4.47|.92
91675093|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.55||||0.82|TWO_SIDED|95.0|-4.15|5.24|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.||5.24|-4.15|.82
91675094|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.71||||0.17|TWO_SIDED|95.0|-1.59|9.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.||9|-1.59|0.17
91716944|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.74|0.76||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 27 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.76|-0.74|>0.99
91485981|NCT03323502|182845236|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3946|TWO_SIDED|95.0|0.85|1.49|||Regression, Logistic|||||1.49|0.85|0.3946
91675095|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|6.01||||0.04|TWO_SIDED|95.0|0.29|11.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.||11.74|0.29|0.04
91675096|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.91||||0.14|TWO_SIDED|95.0|-1.28|9.1|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.||9.1|-1.28|0.14
91675097|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.05|TWO_SIDED|95.0|-0.1|11.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.||11.03|-0.1|0.05
91675098|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.86|TWO_SIDED|95.0|-3.29|3.96|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.||3.96|-3.29|.86
91675099|NCT02312713|183244161|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.59||||0.15|TWO_SIDED|95.0|-0.96|6.13|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.||6.13|-0.96|0.15
91675100|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.11|TWO_SIDED|95.0|-0.85|8.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.||8.11|-0.85|0.11
91675101|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|7.74||||0|TWO_SIDED|95.0|3.39|12.08|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.||12.08|3.39|0
91675102|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|3.29||||0.14|TWO_SIDED|95.0|-1.08|7.67|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.||7.67|-1.08|0.14
91675103|NCT02312713|183244161|SUPERIORITY||Mean Difference (Final Values)|5.15||||0.02|TWO_SIDED|95.0|0.92|9.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.||9.37|0.92|0.02
91675104|NCT02312713|183244162|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.02|TWO_SIDED|95.0|-4.67|-0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.5|-4.67|0.02
91716945|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.38|||>|0.99|TWO_SIDED|95.0|-1.2|0.44||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 30 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.44|-1.20|>0.99
91716946|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.69|0.89||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 33 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.89|-0.69|>0.99
91485982|NCT01675427|182845239|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0018
91675105|NCT02312713|183244162|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.33|TWO_SIDED|95.0|-3.22|1.09|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||1.09|-3.22|0.33
91675106|NCT02312713|183244162|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.52|1.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.74|-2.52|0.72
91675107|NCT02312713|183244162|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.56|TWO_SIDED|95.0|-1.56|2.86|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||2.86|-1.56|0.56
91675108|NCT02312713|183244162|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.19||||0.01|TWO_SIDED|95.0|0.48|3.9|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.9|0.48|0.01
91675109|NCT02312713|183244162|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.71||||0.06|TWO_SIDED|95.0|-0.1|3.52|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||3.52|-0.1|0.06
91675110|NCT02312713|183244163|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.03|TWO_SIDED|95.0|-4.67|-0.26|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.26|-4.67|0.03
91675111|NCT02312713|183244163|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.01|TWO_SIDED|95.0|-4.31|-0.55|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||-0.55|-4.31|0.01
91485983|NCT01675427|182845239|SUPERIORITY_OR_OTHER|||||||0.2289|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.2289
91641894|NCT02203305|183175241|SUPERIORITY||||||<|0.581||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.039) and condition (p=0.007). Interaction: interval and condition (p=0.581).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.581
91641895|NCT02203305|183175241|SUPERIORITY||||||<|0.817||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.817
91675112|NCT02312713|183244163|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.39|TWO_SIDED|95.0|-3.24|1.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.27|-3.24|0.39
91675113|NCT02312713|183244163|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.1|TWO_SIDED|95.0|-3.58|0.29|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.29|-3.58|0.1
91675114|NCT02312713|183244163|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.48||||0.11|TWO_SIDED|95.0|-0.33|3.29|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.29|-0.33|0.11
91675115|NCT02312713|183244163|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.33|TWO_SIDED|95.0|-0.8|2.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.37|-0.8|0.33
91675116|NCT02312713|183244164|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.06|TWO_SIDED|95.0|-1.62|0.04|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.04|-1.62|0.06
91675117|NCT02312713|183244164|SUPERIORITY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.77|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.77|-0.77|1.00
91675118|NCT02312713|183244164|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.41|-1.29|0.31
91485984|NCT01675427|182845239|SUPERIORITY_OR_OTHER|||||||0.1112|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1112
91526566|NCT01225822|182928306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0114||95.0|0.097|0.744|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.744|0.097|0.0114
91526567|NCT01225822|182928307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.332||||0.036||95.0|0.118|0.931|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.931|0.118|0.036
91675119|NCT02312713|183244164|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.58|TWO_SIDED|95.0|-1.01|0.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.57|-1.01|0.58
91485985|NCT01675427|182845239|SUPERIORITY_OR_OTHER|||||||0.4681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.4681
91675120|NCT02312713|183244164|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.35||||0.32|TWO_SIDED|95.0|-0.33|1.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||1.03|-0.33|0.32
91675121|NCT02312713|183244164|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.22||||0.51|TWO_SIDED|95.0|-0.86|0.43|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.43|-0.86|0.51
91675122|NCT02312713|183244165|SUPERIORITY||Mean Difference (Final Values)|6.95||||0.48|TWO_SIDED|95.0|-12.31|26.22|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||26.22|-12.31|0.48
91675123|NCT02312713|183244165|SUPERIORITY||Mean Difference (Final Values)|7.11||||0.41|TWO_SIDED|95.0|-9.69|23.91|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||23.91|-9.69|0.41
91716947|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-1.02|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 36 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-1.02|>0.99
91716948|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.11|||>|0.99|TWO_SIDED|95.0|-0.7|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 39 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.70|>0.99
91716949|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.62|||>|0.99|TWO_SIDED|95.0|-1.36|0.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 42 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.13|-1.36|>0.99
91716950|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.23|||>|0.99|TWO_SIDED|95.0|-1.01|0.55||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 7 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.55|-1.01|>0.99
91716951|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-0.89|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 8 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.89|>0.99
91716952|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|0.02|||>|0.99|TWO_SIDED|95.0|-0.63|0.67||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.67|-0.63|>0.99
91716953|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.17|||>|0.99|TWO_SIDED|95.0|-0.95|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 10 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-0.95|>0.99
91716954|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.42|||>|0.99|TWO_SIDED|95.0|-1.18|0.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 11 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.34|-1.18|>0.99
91716955|NCT04210986|183326187|SUPERIORITY||Contrast of LS Means|-0.35|||>|0.99|TWO_SIDED|95.0|-1.41|0.71||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.71|-1.41|>0.99
91526568|NCT01225822|182928307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||0.3884||95.0|0.293|1.611|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.611|0.293|0.3884
91716956|NCT04210986|183326188|SUPERIORITY||Contrast of LS Means|1.86||||0.9106|TWO_SIDED|95.0|-3.09|6.82||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||6.82|-3.09|0.9106
91675124|NCT02312713|183244165|SUPERIORITY||Mean Difference (Final Values)|-6.82||||0.5|TWO_SIDED|95.0|-26.55|12.91|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||12.91|-26.55|0.50
91675125|NCT02312713|183244165|SUPERIORITY||Mean Difference (Final Values)|7.02||||0.43|TWO_SIDED|95.0|-10.31|24.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||24.35|-10.31|0.43
91675126|NCT02312713|183244165|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-13.77||||0.09|TWO_SIDED|95.0|-29.73|2.19|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||2.19|-29.73|0.09
91675127|NCT02312713|183244165|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.09||||0.99|TWO_SIDED|95.0|-14.41|14.23|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||14.23|-14.41|0.99
91675128|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.36||||0.04|TWO_SIDED|95.0|0.05|2.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercises||2.66|0.05|0.04
91675129|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.09|TWO_SIDED|95.0|-0.18|2.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.||2.6|-0.18|0.09
91675130|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.22|TWO_SIDED|95.0|-0.49|2.19|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.||2.19|-0.49|0.22
91675131|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.06|TWO_SIDED|95.0|-0.08|2.78|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.||2.78|-0.08|0.06
91675132|NCT02312713|183244166|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.51||||0.36|TWO_SIDED|95.0|-1.6|0.58|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.||0.58|-1.6|0.36
91675133|NCT02312713|183244166|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.14||||0.81|TWO_SIDED|95.0|-1.03|1.31|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.||1.31|-1.03|0.81
91675134|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.85||||0|TWO_SIDED|95.0|0.67|3.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.||3.03|0.67|0.00
91675135|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.62||||0|TWO_SIDED|95.0|0.55|2.68|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.||2.68|0.55|0.00
91675136|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.03|TWO_SIDED|95.0|0.16|2.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.||2.57|0.16|0.03
91675137|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|2.07||||0|TWO_SIDED|95.0|0.98|3.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.||3.16|0.98|0.00
91675138|NCT02312713|183244166|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.48||||0.33|TWO_SIDED|95.0|-1.46|0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.||0.5|-1.46|0.33
91675139|NCT02312713|183244166|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.45||||0.32|TWO_SIDED|95.0|-0.44|1.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.||1.34|-0.44|0.32
91675140|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.21|TWO_SIDED|95.0|-0.61|2.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.||2.8|-0.61|0.21
91675141|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|2.07||||0.04|TWO_SIDED|95.0|0.13|4.0|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.||4|0.13|0.04
91675142|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.15|3.62|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.||3.62|0.15|0.03
91675143|NCT02312713|183244166|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.05|TWO_SIDED|95.0|0.01|3.97|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.||3.97|0.01|0.05
91675144|NCT02312713|183244166|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.27|TWO_SIDED|95.0|-0.62|2.2|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.||2.2|-0.62|0.27
91675145|NCT02312713|183244166|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.07||||0.93|TWO_SIDED|95.0|-1.69|1.54|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.||1.54|-1.69|0.93
91675146|NCT05444543|183244219|SUPERIORITY||Odds Ratio (OR)|0.089||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
91675147|NCT05444543|183244220|SUPERIORITY||Odds Ratio (OR)|1.1|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
91675148|NCT01258101|183244256|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to Arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|32.0|||||TWO_SIDED|95.0|10.5|53.5||||||||53.5|10.5|
91675149|NCT01258101|183244256|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-14.0|7.6||||||||7.6|-14.0|
91675150|NCT01258101|183244256|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|-4.7|19.1||||||||19.1|-4.7|
91675151|NCT01258101|183244256|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-21.1|||||TWO_SIDED|95.0|-42.2|-0.1||||||||-0.1|-42.2|
91675152|NCT01258101|183244258|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||||0.2|-1.0|
91675153|NCT01258101|183244258|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-6.4|1.3||||||||1.3|-6.4|
91675154|NCT01258101|183244258|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.4|1.4||||||||1.4|-1.4|
91526569|NCT01225822|182928307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.616||||0.3674||95.0|0.215|1.766|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.766|0.215|0.3674
91675155|NCT01258101|183244258|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||||1.7|-0.5|
91675156|NCT01258101|183244266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.2667|TWO_SIDED||||||Regression, Cox|||||||0.2667
91675157|NCT01258101|183244266|SUPERIORITY_OR_OTHER|||||||0.9999|||||||Regression, Cox|||||||0.9999
91675158|NCT01258101|183244266|SUPERIORITY_OR_OTHER|||||||0.9891|||||||Regression, Cox|||||||0.9891
91675159|NCT00720226|183244292|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Participants demonstrating 5-35% emphysema on baseline CT scan||||0.06
91675160|NCT00720226|183244293|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Participants with 5-35% emphysema at baseline||||0.55
91675161|NCT03438227|183244423|SUPERIORITY|||||||0.039|||||||Chi-squared|||||||0.039
91675162|NCT03438227|183244424|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
91675163|NCT03438227|183244425|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
91675164|NCT03438227|183244426|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
91675165|NCT03438227|183244427|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
91675166|NCT03438227|183244428|SUPERIORITY|||||||0.194|||||||Fisher Exact|||||||0.194
91675167|NCT03438227|183244429|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
91675168|NCT03438227|183244430|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91675169|NCT03438227|183244431|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||0.571
91675170|NCT03438227|183244432|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
91675171|NCT03438227|183244433|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
91675172|NCT03438227|183244434|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
91675173|NCT03438227|183244435|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
91675174|NCT03438227|183244436|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
91675175|NCT01244061|183244454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.08|||<|0.0001|TWO_SIDED|95.0|4.34|11.55||The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value \> 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.||11.55|4.34|<0.0001
91641896|NCT02203305|183175241|SUPERIORITY||||||=|0.008||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.008
91641897|NCT02203305|183175241|SUPERIORITY||||||=|0.009|||||||ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.009
91641898|NCT02203305|183175241|OTHER|bivariate correlation|||||=|0.049||||||"Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.~This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz."|bivariate pearson correlation|||Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.049
91641899|NCT02203305|183175241|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
91641900|NCT02203305|183175242|SUPERIORITY||||||<|0.44|||||||Mixed Models Analysis|Main effects: interval (p=0.070) and condition (p=0.440). Interaction: interval and condition (p=0.047).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.440
91641901|NCT02203305|183175242|SUPERIORITY||||||<|0.379|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.379
91641902|NCT02203305|183175242|SUPERIORITY||||||=|0.021|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.021
91641903|NCT02203305|183175242|SUPERIORITY||||||<|0.001|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
91675176|NCT01244061|183244455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.97|20.41||Statistical significance was declared for each hypothesis in the order above until a p-value \>0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.||20.41|3.97|<0.0001
91675177|NCT01244061|183244456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.83|||<|0.0001|TWO_SIDED|95.0|3.25|10.44||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||||10.44|3.25|<0.0001
91641904|NCT02203305|183175243|SUPERIORITY||||||<|0.639||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: condition (p\<0.001) and interval (p=0.639). Interaction: interval and condition (p=0.280).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.639
91641905|NCT02203305|183175243|SUPERIORITY||||||<|0.637|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.637
91526570|NCT01225822|182928307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.809||||0.5663||95.0|0.393|1.668|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.668|0.393|0.5663
91641906|NCT02203305|183175243|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
91641907|NCT02203305|183175243|SUPERIORITY||||||=|0.002|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.002
91641908|NCT02203305|183175244|SUPERIORITY||||||<|0.671|||||||Mixed Models Analysis|Main effects: interval (p=0.020) and condition (p=0.406). Interaction: interval and condition (p=0.671).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.671
91641909|NCT02203305|183175244|SUPERIORITY||||||>|0.124|||||||Mixed Models Analysis|Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.124
91641910|NCT02203305|183175244|SUPERIORITY||||||=|0.025|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.025
91641911|NCT02203305|183175244|SUPERIORITY||||||=|0.442|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.442
91641912|NCT02203305|183175245|SUPERIORITY||||||<|0.001||||||Percent correct values were converted to rationalized arcsine units prior to analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
91641913|NCT02203305|183175245|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
91641914|NCT02203305|183175246|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
91641915|NCT02203305|183175246|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
91641916|NCT02203305|183175246|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
91641917|NCT02203305|183175246|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
91675178|NCT01244061|183244457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.85|||<|0.0001|TWO_SIDED|95.0|4.92|12.51||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 12 assessment||12.51|4.92|<0.0001
91641918|NCT02203305|183175247|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
91641919|NCT02203305|183175247|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
91692071|NCT05151744|183278734|SUPERIORITY||Difference in Adjusted Mean|-19.4||||0.1071|TWO_SIDED|95.0|-42.9|4.2|||MMRM|||||4.2|-42.9|0.1071
91692072|NCT05151744|183278735|SUPERIORITY||Difference in Adjusted Mean|-14.6||||0.303|TWO_SIDED|95.0|-42.4|13.2|||MMRM|||||13.2|-42.4|0.3030
91692073|NCT05151744|183278736|SUPERIORITY||Difference in Adjusted Mean|-43.0||||0.0878|TWO_SIDED|95.0|-92.4|6.4|||MMRM|||||6.4|-92.4|0.0878
91692074|NCT05151744|183278737|SUPERIORITY||Difference in Adjusted Mean|-22.3||||0.1111|TWO_SIDED|95.0|-49.8|5.2|||MMRM|||||5.2|-49.8|0.1111
91692075|NCT02565628|183278760|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.02|STANDARD_ERROR_OF_MEAN|10.49||0.6382|ONE_SIDED|90.0||8.97|||Mixed Models Analysis|||||8.97||0.6382
91692174|NCT03296527|183279347|SUPERIORITY|||||||0.839||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.839
91485986|NCT01675427|182845239|SUPERIORITY_OR_OTHER|||||||0.4828|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4828
91675179|NCT01244061|183244457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.86|4.64||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 24 assessment||4.64|1.86|<0.0001
91675180|NCT01244061|183244457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.88|4.97||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 52 assessment||4.97|1.88|<0.0001
91675181|NCT03166124|183244458|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.953|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.953|
91675182|NCT03166124|183244458|SUPERIORITY||Ratio of Geometric LSMeans|1.03|||||TWO_SIDED|95.0|0.974|1.09|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.09|0.974|
91675183|NCT03166124|183244459|SUPERIORITY||Ratio of Geometric LSMeans|1.04|||||TWO_SIDED|95.0|0.96|1.12|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.12|0.96|
91675184|NCT03166124|183244459|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.94|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.94|
91716957|NCT04210986|183326188|SUPERIORITY||Contrast of LS Means|-4.2||||0.4424|TWO_SIDED|95.0|-9.93|1.53||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.53|-9.93|0.4424
91675185|NCT00788593|183244460|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|1.023||||0.228|TWO_SIDED|95.0|-0.656|2.701|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.||2.701|-0.656|0.228
91675186|NCT00788593|183244461|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91675187|NCT00788593|183244461|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91675188|NCT00788593|183244462|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91485987|NCT01675427|182845239|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.2702
91485988|NCT01675427|182845240|SUPERIORITY_OR_OTHER|||||||0.4133|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.4133
91675189|NCT00788593|183244462|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91675190|NCT01392326|183244465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53|||<|0.0001|TWO_SIDED|95.0|3.46|8.85|||Regression, Logistic|||||8.85|3.46|<0.0001
91675191|NCT01392326|183244465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.37|8.62|||Regression, Logistic|||||8.62|3.37|<0.0001
91675192|NCT01036490|183244482|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91675193|NCT01036490|183244483|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
91675194|NCT01036490|183244486|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
91675195|NCT01036490|183244487|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||||||0.58
91675196|NCT03959527|183244548|NON_INFERIORITY|A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority \[NI\] margin for the primary endpoint).|Risk Difference (RD)|5.31|||||TWO_SIDED|95.0|1.38|8.65|||||95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin|Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.||8.65|1.38|
91675197|NCT02960893|183244588|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.519|TWO_SIDED|95.0|-0.5|0.9||Significance was evaluated at a 2-sided alpha level of 0.05|Mixed Model with Repeated Measures|Fixed effects: treatment, baseline (BL) gait severity, visit, treatment-by-visit interaction; Covariate: BL Total SARA score; Random effect: subject||||0.9|-0.5|0.519
91675198|NCT03692312|183244594|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.875||0.0514|TWO_SIDED|95.0|-0.01|3.51|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||3.51|-0.01|0.0514
91675199|NCT03692312|183244595|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.268||0.2124|TWO_SIDED|95.0|-0.2|0.88|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.88|-0.20|0.2124
91485989|NCT01675427|182845240|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.4400
91641920|NCT02203305|183175247|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p\<0.001). Interaction: interval and subscales (p\<0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.001
91641921|NCT02203305|183175247|SUPERIORITY||||||<|0.01||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.010
91641922|NCT02203305|183175248|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||<0.001
91641923|NCT02203305|183175248|SUPERIORITY||||||=|0.003||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||=0.003
91641924|NCT02203305|183175249|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
91641925|NCT02203305|183175249|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
91641926|NCT02203305|183175249|SUPERIORITY||||||<|0.001||||||"There were significant main effects of interval (p\<0.001) and subscale (p\<0.001) and interaction (p=0.001).~A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity."|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.001).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.001
91641927|NCT02203305|183175249|SUPERIORITY||||||<|0.034||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.034).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.034
91641928|NCT02203305|183175249|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
91641929|NCT02203305|183175249|SUPERIORITY||||||<|0.192|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.192
91641930|NCT02203305|183175249|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
91641931|NCT02203305|183175249|SUPERIORITY||||||<|0.479|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.479).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.479
91485990|NCT01675427|182845240|SUPERIORITY_OR_OTHER|||||||0.8597|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.8597
91485991|NCT01675427|182845240|SUPERIORITY_OR_OTHER|||||||0.3975|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.3975
91485992|NCT01675427|182845240|SUPERIORITY_OR_OTHER|||||||0.1781|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1781
91641932|NCT02203305|183175249|SUPERIORITY||||||<|0.804|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.804
91641933|NCT02203305|183175249|SUPERIORITY||||||<|0.005|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.005).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.005
91485993|NCT01675427|182845240|SUPERIORITY_OR_OTHER|||||||0.3159|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3159
91641934|NCT02203305|183175250|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
91641935|NCT02203305|183175250|SUPERIORITY||||||=|0.034|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.034
91641936|NCT02203305|183175251|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
91641937|NCT02203305|183175251|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.037
91641938|NCT02203305|183175252|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||<0.001
91641939|NCT02203305|183175252|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
91641940|NCT02203305|183175253|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.||||=0.004
91641941|NCT02203305|183175253|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.004
91641942|NCT02203305|183175254|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||<0.001
91641943|NCT02203305|183175254|SUPERIORITY||||||=|0.727|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.727
91692175|NCT03296527|183279348|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
91485994|NCT01675427|182845241|SUPERIORITY_OR_OTHER|||||||0.0126|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0126
91485995|NCT01675427|182845241|SUPERIORITY_OR_OTHER|||||||0.7174|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.7174
91485996|NCT01675427|182845241|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1380
91716958|NCT04210986|183326188|SUPERIORITY||Contrast of LS Means|-0.03||||0.9901|TWO_SIDED|95.0|-5.55|5.48||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||5.48|-5.55|0.9901
91716959|NCT04210986|183326189|SUPERIORITY||Contrast of LS Means|0.69|||>|0.99|TWO_SIDED|95.0|-30.95|32.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||32.3|-30.95|>0.99
91716960|NCT04210986|183326189|SUPERIORITY||Contrast of LS Means|-11.3|||>|0.99|TWO_SIDED|95.0|-46.9|24.2||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||24.2|-46.9|>0.99
91716961|NCT04210986|183326190|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.474|TWO_SIDED|95.0|0.05|4.21||A priori threshold for statistical significance = 0.05.|Log Rank|Cox proportional hazards model constructed. Score (log rank) test to assess between group difference in hazard rate.|Hazard ratio expresses the hazard rate of the Fisetin group in the numerator and the hazard rate of the Placebo group in the denominator|With only 4 participants that converted to an alternative treatment modality, this analysis is underpowered.||4.21|0.05|0.474
91716962|NCT05222880|183326194|SUPERIORITY|A superiority Margin of 0.00 logMAR was used for distance.|Mean Population Estimate|-0.1|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.12|-0.08||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 17 subjects were required to test the primary hypothesis for Distance.||-0.08|-0.12|
91716963|NCT05222880|183326194|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for Intermediate.|Mean Population Estimate|-0.04|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.06|-0.02||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate.||-0.02|-0.06|
91716964|NCT05222880|183326194|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for near.|Mean Population Estimate|0.07|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|99.0|0.05|0.09||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near.||0.09|0.05|
91716965|NCT05222880|183326195|SUPERIORITY|A superiority Margin of 36 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 14 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
91485997|NCT01675427|182845241|SUPERIORITY_OR_OTHER|||||||0.6258|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.6258
91485998|NCT01675427|182845241|SUPERIORITY_OR_OTHER|||||||0.5751|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.5751
91716966|NCT05222880|183326195|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 18 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
91485999|NCT01675427|182845241|SUPERIORITY_OR_OTHER|||||||0.1681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.1681
91486000|NCT01675427|182845242|SUPERIORITY_OR_OTHER|||||||0.2693|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.2693
91486001|NCT01675427|182845242|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.3240
91716967|NCT05222880|183326196|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0019|STANDARD_DEVIATION|0.00209|||TWO_SIDED|95.0|0.0|0.0076|||Bayesian beta- binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0076|0.0000|
91486002|NCT01675427|182845242|SUPERIORITY_OR_OTHER|||||||0.7006|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7006
91641944|NCT02203305|183175255|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.001
91641945|NCT02203305|183175255|SUPERIORITY||||||=|0.09|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.090
91486003|NCT01675427|182845242|SUPERIORITY_OR_OTHER|||||||0.0403|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.0403
91486004|NCT01675427|182845242|SUPERIORITY_OR_OTHER|||||||0.1075|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1075
91486005|NCT01675427|182845242|SUPERIORITY_OR_OTHER|||||||0.3295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3295
91486006|NCT01675427|182845243|SUPERIORITY_OR_OTHER|||||||0.9859|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9859
91486007|NCT01675427|182845243|SUPERIORITY_OR_OTHER|||||||0.7055|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.7055
91641946|NCT02203305|183175261|SUPERIORITY||||||<|0.923|||||||Mixed Models Analysis|Main effect: electrode (p\<0.001), target stimulus (p=0.923), and interval (p=0.226). Interaction: electrode and interval (p=0.496).||A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.||||<0.923
91641947|NCT02203305|183175261|OTHER||||||>|0.164|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.||||>0.164
91675200|NCT03692312|183244596|SUPERIORITY||Mean Difference (Final Values)|4.74|STANDARD_ERROR_OF_MEAN|1.104|<|0.0001|TWO_SIDED|95.0|2.51|6.96|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||6.96|2.51|<0.0001
91486008|NCT01675427|182845243|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0920
91486009|NCT01675427|182845243|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0781
91486010|NCT01675427|182845243|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4795
91486011|NCT01675427|182845243|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3069
91486012|NCT01675427|182845244|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5216
91486013|NCT01675427|182845244|SUPERIORITY_OR_OTHER|||||||0.3419|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3419
91641948|NCT02203305|183175261|OTHER|bivariate pearson correlation|||||>|0.367|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).||||>0.367
91641949|NCT02203305|183175261|OTHER|bivariate pearson correlation|||||>|0.349|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).||||>0.349
91486014|NCT01675427|182845244|SUPERIORITY_OR_OTHER|||||||0.7586|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.7586
91486015|NCT01675427|182845244|SUPERIORITY_OR_OTHER|||||||0.1351|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1351
91486016|NCT01675427|182845244|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
91486017|NCT01675427|182845244|SUPERIORITY_OR_OTHER|||||||0.3921|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3921
91486018|NCT01675427|182845245|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8537
91486019|NCT01675427|182845245|SUPERIORITY_OR_OTHER|||||||0.0763|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0763
91486020|NCT01675427|182845245|SUPERIORITY_OR_OTHER|||||||0.2432|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2432
91486021|NCT01675427|182845245|SUPERIORITY_OR_OTHER|||||||0.4247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4247
91486022|NCT01675427|182845245|SUPERIORITY_OR_OTHER|||||||0.4884|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4884
91716968|NCT05222880|183326197|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0018|STANDARD_DEVIATION|0.0021|||TWO_SIDED|95.0|0.0|0.0078|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0078|0.0000|
91716969|NCT05222880|183326198|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 16 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
91486023|NCT01675427|182845245|SUPERIORITY_OR_OTHER|||||||0.6119|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6119
91486024|NCT01675427|182845246|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2416
91486025|NCT01675427|182845246|SUPERIORITY_OR_OTHER|||||||0.2671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2671
91486026|NCT01675427|182845246|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.4619
91486027|NCT01675427|182845246|SUPERIORITY_OR_OTHER|||||||0.8364|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.8364
91486028|NCT01675427|182845246|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
91486029|NCT01675427|182845246|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2887
91486030|NCT01675427|182845247|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0049
91486031|NCT01675427|182845248|SUPERIORITY_OR_OTHER|||||||0.5651|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.5651
91486032|NCT01675427|182845249|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0420
91526571|NCT01225822|182928307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.1678||95.0|0.242|1.28|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.28|0.242|0.1678
91526572|NCT01225822|182928307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0113||95.0|0.097|0.743|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.743|0.097|0.0113
91716970|NCT05222880|183326198|SUPERIORITY|A superiority Margin of 46 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 15 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
91486033|NCT01675427|182845250|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.4545
91486034|NCT01675427|182845251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486035|NCT01675427|182845252|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486036|NCT01675427|182845253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486037|NCT01675427|182845254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486038|NCT01675427|182845255|SUPERIORITY_OR_OTHER|||||||0.5468|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.5468
91486039|NCT01675427|182845256|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0020
91486040|NCT01675427|182845257|SUPERIORITY_OR_OTHER|||||||0.1623|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.1623
91486041|NCT01675427|182845258|SUPERIORITY_OR_OTHER|||||||0.0663|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0663
91486042|NCT01675427|182845259|SUPERIORITY_OR_OTHER|||||||0.2617|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.2617
91486043|NCT01675427|182845260|SUPERIORITY_OR_OTHER|||||||0.0526|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0526
91486044|NCT01675427|182845261|SUPERIORITY_OR_OTHER|||||||0.7918|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.7918
91486045|NCT01675427|182845262|SUPERIORITY_OR_OTHER|||||||0.0842|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0842
91486046|NCT01675427|182845263|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486047|NCT01675427|182845264|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486048|NCT01675427|182845265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486049|NCT01675427|182845266|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486050|NCT01675427|182845267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91526573|NCT01225822|182928308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.818||||0.0077||95.0|2.077|120.474|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||120.474|2.077|0.0077
91675201|NCT03692312|183244597|SUPERIORITY||Mean Difference (Final Values)|3.18|STANDARD_ERROR_OF_MEAN|1.099||0.0059|TWO_SIDED|95.0|0.96|5.39|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||5.39|0.96|0.0059
91675202|NCT03692312|183244598|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4634|TWO_SIDED|95.0|-0.3|0.14|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.14|-0.30|0.4634
91486051|NCT01675427|182845267|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2887
91486052|NCT01675427|182845267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
91486053|NCT01675427|182845267|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1634
91486054|NCT01675427|182845267|SUPERIORITY_OR_OTHER|||||||0.8956|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8956
91486055|NCT01675427|182845267|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91486056|NCT01675427|182845268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91526574|NCT01225822|182928308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.907||||0.0062||95.0|2.229|128.238|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||128.238|2.229|0.0062
91675203|NCT03692312|183244599|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.564||0.5385|TWO_SIDED|95.0|-1.49|0.79|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.79|-1.49|0.5385
91486057|NCT01675427|182845268|SUPERIORITY_OR_OTHER|||||||0.0145|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0145
91486058|NCT01675427|182845268|SUPERIORITY_OR_OTHER|||||||0.1027|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1027
91486059|NCT01675427|182845268|SUPERIORITY_OR_OTHER|||||||0.5998|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5998
91486060|NCT01675427|182845268|SUPERIORITY_OR_OTHER|||||||0.2935|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2935
91486061|NCT01675427|182845268|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0039
91486062|NCT01675427|182845269|SUPERIORITY_OR_OTHER|||||||0.1981|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1981
91486063|NCT01675427|182845269|SUPERIORITY_OR_OTHER|||||||0.1616|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1616
91486064|NCT01675427|182845269|SUPERIORITY_OR_OTHER|||||||0.1192|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1192
91486065|NCT01675427|182845269|SUPERIORITY_OR_OTHER|||||||0.4485|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4485
91486066|NCT01675427|182845269|SUPERIORITY_OR_OTHER|||||||0.1525|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1525
91486067|NCT01675427|182845269|SUPERIORITY_OR_OTHER|||||||0.7262|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7262
91692176|NCT03296527|183279348|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
91692177|NCT03296527|183279348|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||<.001
91526575|NCT01225822|182928308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.7192||95.0|0.567|2.276|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as for primary endpoint||2.276|0.567|0.7192
91641950|NCT02203305|183175262|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||"Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||<0.001
91641951|NCT02203305|183175262|SUPERIORITY||||||=|0.47|||||||ANOVA|generalized linear mixed-effects model||"Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||=0.47
91675204|NCT03692312|183244602|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.764||0.711|TWO_SIDED|95.0|-1.26|1.83|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||1.83|-1.26|0.7110
91675205|NCT03692312|183244603|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.326||0.7861|TWO_SIDED|95.0|-0.57|0.75|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.75|-0.57|0.7861
91675206|NCT03692312|183244604|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6282|TWO_SIDED|95.0|-0.19|0.31|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. A compound symmetry variance-covariance matrix has been used.||0.31|-0.19|0.6282
91675207|NCT03692312|183244605|SUPERIORITY|||||||0.0428|||||||t-test, 2 sided|||||||0.0428
91675208|NCT03692312|183244606|SUPERIORITY||Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.094||0.0379|TWO_SIDED|95.0|0.6|0.98|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.98|0.60|0.0379
91675209|NCT03692312|183244608|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.078
91675210|NCT03692312|183244610|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.29
91641952|NCT02203305|183175263|SUPERIORITY||||||=|0.739|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.739
91675211|NCT03692312|183244612|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline (absolute value); two-tailed t-test assuming unequal variance.||||0.077
91675212|NCT03692312|183244613|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Cmax upper quantiles group compared to placebo group for mean Raw Score; two-tailed t-test assuming unequal variance.||||0.071
91716971|NCT05222880|183326199|SUPERIORITY|A Superiority margin of 52 CLUE points was used|Mean Population Estimate|72.6|STANDARD_ERROR_OF_MEAN|1.763|||TWO_SIDED|99.0|68.1|77.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 11 subjects were required to test for superiority for CLUE comfort scores.||77.1|68.1|
91526576|NCT01225822|182928308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.121||||0.0472||95.0|0.015|0.974|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||0.974|0.015|0.0472
91675213|NCT04285567|183244668|SUPERIORITY||Difference in Rates|26.6||||0.0004|TWO_SIDED|95.0|12.33|40.87|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.||40.87|12.33|0.0004
91675214|NCT04285567|183244670|SUPERIORITY||Difference in Rates|20.78||||0.0053|TWO_SIDED|95.0|6.66|34.9|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||34.90|6.66|0.0053
91675215|NCT04285567|183244671|SUPERIORITY||Difference in Rates|31.63|||<|0.0001|TWO_SIDED|95.0|16.55|46.71|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||46.71|16.55|< .0001
91675216|NCT04285567|183244672|SUPERIORITY||Difference in Response Rates|9.68||||0.1119|TWO_SIDED|95.0|-2.05|21.41|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||21.41|-2.05|0.1119
91675217|NCT04285567|183244673|SUPERIORITY||Difference in Response Rates|17.44||||0.0154|TWO_SIDED|95.0|1.96|32.93|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||32.93|1.96|0.0154
91675218|NCT04285567|183244674|SUPERIORITY||Difference in Rates|18.93||||0.0054|TWO_SIDED|95.0|0.91|36.95|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||36.95|0.91|0.0054
91675219|NCT04285567|183244675|SUPERIORITY||Difference in Rates|26.79||||0.0038|TWO_SIDED|95.0|3.86|49.72|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||49.72|3.86|0.0038
91641953|NCT02203305|183175263|SUPERIORITY||||||=|0.553|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.553
91641954|NCT02203305|183175264|SUPERIORITY||||||<|0.345||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: interval (p=0.027) and masker condition (p\<0.001). Interaction: interval and masker condition (p=0.345).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.345
91641955|NCT02203305|183175264|SUPERIORITY||||||<|0.577||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: masker condition (p\<0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.577
91641956|NCT02203305|183175265|SUPERIORITY||||||>|0.023|||||||Mixed Models Analysis|Main effect: coding strategy (p=0.023). Interaction: coding strategy and electrode (p=0.044). All other main effects and interactions were p\>0.160.||A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.||||>0.023
91675220|NCT04285567|183244677|SUPERIORITY||Difference in Response Rates|3.05||||0.4199|TWO_SIDED|95.0|-5.73|11.84|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||11.84|-5.73|0.4199
91675221|NCT02246439|183244702|SUPERIORITY||Odds Ratio (OR)|1.6081||||0.0406|TWO_SIDED|95.0|1.0194|2.5368||"This P-Value is for the All ages group"|Cochran-Mantel-Haenszel|Stratified by age.||The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the 'All ages' category, the odds ratio and p-value were stratified by age.||2.5368|1.0194|0.0406
91641957|NCT02203305|183175265|SUPERIORITY||||||>|0.035|||||||t-test, 2 sided|Pitch perception for electrode 1 (p=0.035). All other comparisons were p\>0.318.||Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.||||>0.035
91716972|NCT05222880|183326200|SUPERIORITY|A Superiority margin of 53 CLUE points was used|Mean Population Estimate|67.6|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|99.0|63.0|72.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 17 subjects were required to test for superiority for CLUE handling scores.||72.1|63.0|
91716973|NCT05222880|183326201|SUPERIORITY|A superiority margin of 0.90 was used.|Mean Posterior Proportion|0.985|STANDARD_DEVIATION|0.0071|||TWO_SIDED|99.0|0.959|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.98 and an intraclass correlation of 0.70 with 2000 replicating trials, that 92 subjects were required to test for superiority to achieve a minimum statistical power of 80% with 99% central posterior credible.||0.997|0.959|
91716974|NCT01077323|183326205|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.59|1.28|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||1.28|0.59|
91641958|NCT02203305|183175266|SUPERIORITY||||||>|0.084|||||||ANOVA|Main effects: condition (p=0.960) and interval (p=0.084). Interaction: condition and interval (p=0.433).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.084
91641959|NCT02203305|183175266|SUPERIORITY||||||>|0.434|||||||ANOVA|Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.434
91641960|NCT02203305|183175267|SUPERIORITY||||||<|0.935||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|ANOVA|Main effects: condition (p=0.018), interval (p=0.012), and masker (p\<0.001). Interactions: interval and masker (p\<0.001). Other interactions: p\>0.117.||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.935
91675222|NCT02246439|183244702|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0729|TWO_SIDED|95.0|0.847|27.2024||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||27.2024|0.8470|0.0729
91716975|NCT01077323|183326206|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.1|||||TWO_SIDED|95.0|0.8|1.5|||||ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.Rate ratios adjusted for propensity score of exenatide initiation using Cox Proportional Hazards Regression|||1.5|0.8|
91716976|NCT01077323|183326207|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.36|2.09|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.09|0.36|
91716977|NCT01077323|183326208|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.39|||||TWO_SIDED|95.0|0.86|2.25|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.25|0.86|
91486068|NCT01675427|182845270|SUPERIORITY_OR_OTHER|||||||0.0911|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0911
91675223|NCT02246439|183244702|SUPERIORITY||Odds Ratio (OR)|1.4755||||0.1089|TWO_SIDED|95.0|0.917|2.3741||"This P-Value is for the 18 years of age and older group"|Cochran-Mantel-Haenszel|||||2.3741|0.9170|0.1089
91486069|NCT01675427|182845270|SUPERIORITY_OR_OTHER|||||||0.4674|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4674
91675224|NCT02246439|183244703|SUPERIORITY||Odds Ratio (OR)|1.3545||||0.1843|TWO_SIDED|95.0|0.8647|2.1216|||Cochran-Mantel-Haenszel|Stratified by age.||||2.1216|0.8647|0.1843
91675225|NCT02246439|183244704|SUPERIORITY||Odds Ratio (OR)|1.752||||0.0166|TWO_SIDED|95.0|1.1058|2.776|||Cochran-Mantel-Haenszel|Stratified by age.||||2.7760|1.1058|0.0166
91675226|NCT02246439|183244705|SUPERIORITY||Odds Ratio (OR)|0.6677||||0.1049|TWO_SIDED|95.0|0.4093|1.0892|||Cochran-Mantel-Haenszel|Stratified by age.||||1.0892|0.4093|0.1049
91675227|NCT02246439|183244706|SUPERIORITY||Odds Ratio (OR)|0.6566||||0.1235|TWO_SIDED|95.0|0.3826|1.1268|||Cochran-Mantel-Haenszel|Stratified by age.||||1.1268|0.3826|0.1235
91675228|NCT02246439|183244708|SUPERIORITY|||||||0.589||||||This P-Value is for the BSS=7 group.|Wilcoxon (Mann-Whitney)|||||||0.5890
91675229|NCT02246439|183244709|SUPERIORITY||Hazard Ratio (HR)|0.9782||||0.8487|TWO_SIDED|95.0|0.7803|1.2264||"This P-Value is for the All ages group."|Cox proportioanl hazards method|Stratified by age.||||1.2264|0.7803|0.8487
91675230|NCT02246439|183244709|SUPERIORITY||Hazard Ratio (HR)|1.4756||||0.3479|TWO_SIDED|95.0|0.6549|3.325||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.3250|0.6549|0.3479
91486070|NCT01675427|182845270|SUPERIORITY_OR_OTHER|||||||0.1604|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1604
91486071|NCT01675427|182845270|SUPERIORITY_OR_OTHER|||||||0.5937|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5937
91675231|NCT02246439|183244709|SUPERIORITY||Hazard Ratio (HR)|0.9445||||0.6332|TWO_SIDED|95.0|0.7469|1.1943||"This P-Value is for the 18 years of age of older group."|Cox proportional hazards method|||||1.1943|0.7469|0.6332
91675232|NCT02246439|183244710|SUPERIORITY||Hazard Ratio (HR)|1.0275||||0.8289|TWO_SIDED|95.0|0.8036|1.3138||"This P-Value was for the All ages group."|Cox proportional hazards method|Stratified by age.||||1.3138|0.8036|0.8289
91486072|NCT01675427|182845270|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3830
91486073|NCT01675427|182845270|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0507
91486074|NCT01675427|182845271|SUPERIORITY_OR_OTHER|||||||0.8686|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8686
91675233|NCT02246439|183244710|SUPERIORITY||Hazard Ratio (HR)|1.5744||||0.3241|TWO_SIDED|95.0|0.6388|3.8802||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.8802|0.6388|0.3241
91675234|NCT02246439|183244710|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9511|TWO_SIDED|95.0|0.7688|1.2801||"This P-Value is for the 18 years of age or older group."|Cox proportional hazards method|||||1.2801|0.7688|0.9511
91675235|NCT02246439|183244711|SUPERIORITY||Odds Ratio (OR)|2.3012||||0.2005|TWO_SIDED|95.0|0.6221|8.5129|||Cochran-Mantel-Haenszel|||||8.5129|0.6221|0.2005
91675236|NCT02246439|183244712|SUPERIORITY||Odds Ratio (OR)|0.6674||||0.572|TWO_SIDED|95.0|0.1638|2.7191|||Cochran-Mantel-Haenszel|||||2.7191|0.1638|0.5720
91675237|NCT02246439|183244713|SUPERIORITY||Odds Ratio (OR)|2.1591||||0.3186|TWO_SIDED|95.0|0.477|9.7735||"This P-Value is for the No nausea or mild nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||9.7735|0.4770|0.3186
91675238|NCT02246439|183244713|SUPERIORITY||Odds Ratio (OR)|1.575||||0.3473|TWO_SIDED|95.0|0.6096|4.0696||"This P-Value is for the Moderate nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0696|0.6096|0.3473
91675239|NCT02246439|183244713|SUPERIORITY||Odds Ratio (OR)|2.0971||||0.0633|TWO_SIDED|95.0|0.9614|4.5747||"This P-Value is for the Severe nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.5747|0.9614|0.0633
91675240|NCT02246439|183244713|SUPERIORITY||Odds Ratio (OR)|1.6397||||0.2797|TWO_SIDED|95.0|0.6649|4.0437||"This P-Value is for the Nausea as bad as it could have been group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0437|0.6649|0.2797
91675241|NCT02246439|183244714|SUPERIORITY||Odds Ratio (OR)|1.8673||||0.0103|TWO_SIDED|95.0|1.1572|3.0131||"This P-Value is for the All ages group."|Cochran-Mantel-Haenszel|Stratified by age.||||3.0131|1.1572|0.0103
91675242|NCT02246439|183244714|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0934|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0934
91675243|NCT02246439|183244714|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
91675244|NCT02246439|183244715|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0924|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0924
91675245|NCT02246439|183244715|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
91675246|NCT02246439|183244716|SUPERIORITY||Odds Ratio (OR)|1.7922||||0.0152|TWO_SIDED|95.0|1.1188|2.871|||Regression, Logistic|||||2.8710|1.1188|0.0152
91675247|NCT02246439|183244717|SUPERIORITY||Odds Ratio (OR)|2.0789||||0.0037|TWO_SIDED|95.0|1.2676|3.4095|||Regression, Logistic|||||3.4095|1.2676|0.0037
91692178|NCT03296527|183279348|SUPERIORITY|||||||0.011|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.011
91692179|NCT03296527|183279349|SUPERIORITY|||||||0.14|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.140
91526577|NCT01225822|182928308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.049||||0.1043||95.0|0.862|4.868|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.868|0.862|0.1043
91675248|NCT03439852|183244719|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.05|TWO_SIDED|95.0|0.26|1.39|||Mixed Models Analysis|||Multilevel modeling for repeated measures was conducted to compare 2 conditions over time. The model included group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||1.39|0.26|<0.05
91675249|NCT03439852|183244720|SUPERIORITY||Median Difference (Net)|1.14||||0.05|TWO_SIDED|95.0|-0.37|2.64||Calculated|Mixed Models Analysis|||Multilevel modeling conducted for repeated measures comparing minutes per week of light-to-moderate physical activity for participants in two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||2.64|-0.37|0.05
91675250|NCT03439852|183244721|SUPERIORITY||Mean Difference (Net)|-0.72||||0.05|TWO_SIDED|95.0|-2.31|0.88|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||0.88|-2.31|0.05
91675251|NCT03439852|183244722|SUPERIORITY||Mean Difference (Net)|0.96|||<|0.05|TWO_SIDED|95.0|-2.67|4.6|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation.||4.60|-2.67|<0.05
91675252|NCT03439852|183244723|SUPERIORITY||Mean Difference (Net)|-0.76|||<|0.05|TWO_SIDED|95.0|-1.11|-0.4|||Mixed Models Analysis|||||-0.40|-1.11|<0.05
91675253|NCT03439852|183244724|SUPERIORITY||Mean Difference (Net)|-0.62|||<|0.05|TWO_SIDED|95.0|-1.15|0.1|||Mixed Models Analysis|||||0.10|-1.15|<0.05
91675254|NCT03439852|183244725|SUPERIORITY||Median Difference (Net)|-0.49|||<|0.05|TWO_SIDED|95.0|-2.1|1.11|||Mixed Models Analysis|Repeated measures generalized linear model test effects of time/group, \& interaction rate met MVPA, adjusting for within subject correlation.||||1.11|-2.10|<0.05
91675255|NCT04551911|183244730|OTHER|||||||0.7856|||||||Regression, Logistic|Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates||||||0.7856
91675256|NCT01383421|183244738|SUPERIORITY||||||<|0.001||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||< 0.001
91675257|NCT01383421|183244740|SUPERIORITY|||||||0.058||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.058
91526578|NCT01225822|182928308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.917||||0.1448||95.0|0.799|4.597|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.597|0.799|0.1448
91526579|NCT01225822|182928310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.871||||0.0063|TWO_SIDED|95.0|2.221|128.142|||Regression, Logistic|||||128.142|2.221|0.0063
91526580|NCT01225822|182928310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.338||||0.0025|TWO_SIDED|95.0|2.983|167.268|||Regression, Logistic|||||167.268|2.983|0.0025
91526581|NCT01225822|182928310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.919||||0.7973|TWO_SIDED|95.0|0.483|1.75|||Regression, Logistic|||||1.750|0.483|0.7973
91526582|NCT01225822|182928310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.068||||0.0097|TWO_SIDED|95.0|0.009|0.522|||Regression, Logistic|||||0.522|0.009|0.0097
91675258|NCT01383421|183244742|SUPERIORITY|||||||0.003||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.003
91675259|NCT01383421|183244744|SUPERIORITY||LS Mean Difference|-0.203|STANDARD_ERROR_OF_MEAN|0.092||0.027|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.027
91675260|NCT01383421|183244744|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.094||0.006|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.006
91675261|NCT01383421|183244744|SUPERIORITY||LS Mean Difference|-0.233|STANDARD_ERROR_OF_MEAN|0.098||0.018|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.018
91675262|NCT01383421|183244745|SUPERIORITY||LS Mean Difference|-1.686|STANDARD_ERROR_OF_MEAN|0.893||0.059|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.059
91675263|NCT01383421|183244745|SUPERIORITY||LS Mean Difference|-2.697|STANDARD_ERROR_OF_MEAN|0.903||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.003
91675264|NCT01383421|183244745|SUPERIORITY||LS Mean Difference|-2.447|STANDARD_ERROR_OF_MEAN|0.945||0.01|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.010
91675265|NCT01383421|183244746|SUPERIORITY||LS Mean Difference|-1.791|STANDARD_ERROR_OF_MEAN|0.788||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.023
91675266|NCT01383421|183244746|SUPERIORITY||LS Mean Difference|-2.549|STANDARD_ERROR_OF_MEAN|0.818||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.002
91692180|NCT03296527|183279349|SUPERIORITY|||||||0.155|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.155
91486075|NCT01675427|182845271|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3135
91675267|NCT01383421|183244746|SUPERIORITY||LS Mean Difference|-2.734|STANDARD_ERROR_OF_MEAN|0.872||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.002
91675268|NCT01383421|183244750|SUPERIORITY||LS Mean Difference|1.333|STANDARD_ERROR_OF_MEAN|2.725||0.625|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.625
91675269|NCT01383421|183244750|SUPERIORITY||LS Mean Difference|-0.824|STANDARD_ERROR_OF_MEAN|2.441||0.736|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.736
91675270|NCT01383421|183244750|SUPERIORITY||LS Mean Difference|1.207|STANDARD_ERROR_OF_MEAN|3.126||0.7|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.700
91675271|NCT01383421|183244750|SUPERIORITY||LS Mean Difference|-3.552|STANDARD_ERROR_OF_MEAN|1.561||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.023
91675272|NCT01383421|183244751|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|2.736||0.89|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.890
91675273|NCT01383421|183244751|SUPERIORITY||LS Mean Difference|-0.527|STANDARD_ERROR_OF_MEAN|2.523||0.835|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.835
91675274|NCT01383421|183244751|SUPERIORITY||LS Mean Difference|-0.471|STANDARD_ERROR_OF_MEAN|3.205||0.883|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.883
91675275|NCT01383421|183244751|SUPERIORITY||LS Mean Difference|-3.792|STANDARD_ERROR_OF_MEAN|1.611||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.019
91675276|NCT01383421|183244752|SUPERIORITY||LS Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|2.548||0.873|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.873
91675277|NCT01383421|183244752|SUPERIORITY||LS Mean Difference|-0.817|STANDARD_ERROR_OF_MEAN|2.598||0.753|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.753
91675278|NCT01383421|183244752|SUPERIORITY||LS Mean Difference|-2.334|STANDARD_ERROR_OF_MEAN|3.159||0.461|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.461
91675279|NCT01383421|183244752|SUPERIORITY||LS Mean Difference|-5.537|STANDARD_ERROR_OF_MEAN|1.624|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||<0.001
91675280|NCT01383421|183244753|SUPERIORITY||LS Mean Difference|2.973|STANDARD_ERROR_OF_MEAN|1.245||0.017|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.017
91675281|NCT01383421|183244753|SUPERIORITY||LS Mean Difference|2.843|STANDARD_ERROR_OF_MEAN|2.042||0.164|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.164
91675282|NCT01383421|183244753|SUPERIORITY||LS Mean Difference|5.473|STANDARD_ERROR_OF_MEAN|1.866||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.003
91486076|NCT01675427|182845271|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0578
91486077|NCT01675427|182845271|SUPERIORITY_OR_OTHER|||||||0.5833|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5833
91486078|NCT01675427|182845271|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1610
91486079|NCT01675427|182845271|SUPERIORITY_OR_OTHER|||||||0.2925|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2925
91526583|NCT01225822|182928310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.522||||0.2375|TWO_SIDED|95.0|0.758|3.058|||Regression, Logistic|||||3.058|0.758|0.2375
91675283|NCT01383421|183244753|SUPERIORITY||LS Mean Difference|1.705|STANDARD_ERROR_OF_MEAN|1.769||0.335|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.335
91716978|NCT02984982|183326209|SUPERIORITY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.36||0.2279|TWO_SIDED|95.0|-4.32|1.04||Threshold for significance at 0.05 level.|ANCOVA||Standard of Care vs Alirocumab|Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.||1.04|-4.32|0.2279
91716979|NCT04232839|183326239|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.9|||||TWO_SIDED|90.0|80.3|91.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.7|80.3|
91716980|NCT04232839|183326239|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.6|||||TWO_SIDED|90.0|68.0|77.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.6|68.0|
91716981|NCT04232839|183326239|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.4|||||TWO_SIDED|90.0|86.5|98.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.8|86.5|
91716982|NCT04232839|183326239|OTHER||Adjusted geometric mean (gMean) ratio(%)|76.6|||||TWO_SIDED|90.0|71.6|81.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||81.8|71.6|
91716983|NCT04232839|183326239|OTHER||Adjusted geometric mean (gMean) ratio(%)|133.4|||||TWO_SIDED|90.0|117.2|151.9|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.6.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||151.9|117.2|
91716984|NCT04232839|183326239|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.2|||||TWO_SIDED|90.0|102.3|127.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.2.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||127.6|102.3|
91716985|NCT04232839|183326240|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.5|||||TWO_SIDED|90.0|80.0|91.4|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.4|80.0|
91486080|NCT01675427|182845272|SUPERIORITY_OR_OTHER|||||||0.3709|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3709
91486081|NCT01675427|182845272|SUPERIORITY_OR_OTHER|||||||0.2054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2054
91486082|NCT01675427|182845272|SUPERIORITY_OR_OTHER|||||||0.8457|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.8457
91716986|NCT04232839|183326240|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.1|||||TWO_SIDED|90.0|67.4|77.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.1|67.4|
91716987|NCT04232839|183326240|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.2|||||TWO_SIDED|90.0|86.3|98.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.6|86.3|
91716988|NCT04232839|183326240|OTHER||Adjusted geometric mean (gMean) ratio(%)|75.5|||||TWO_SIDED|90.0|70.6|80.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||80.7|70.6|
91486083|NCT01675427|182845272|SUPERIORITY_OR_OTHER|||||||0.3492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3492
91486084|NCT01675427|182845272|SUPERIORITY_OR_OTHER|||||||0.2846|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2846
91486085|NCT01675427|182845272|SUPERIORITY_OR_OTHER|||||||0.2646|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2646
91486086|NCT01675427|182845273|SUPERIORITY_OR_OTHER|||||||0.5348|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5348
91486087|NCT01675427|182845273|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5469
91641961|NCT02203305|183175267|SUPERIORITY||||||<|0.977||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|Effects: interval (p=0.012) and masker (p\<0.001). Interactions: interval\&masker (p=0.020) \& condition, interval, \&masker (p=0.035). Others: (p\>0.131).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.977
91641962|NCT03586427|183175268|OTHER|Mixed model of repeated measures least square estimates of change compared to placebo|||||>|0.05||||||Comparison of each dose level change from baseline to placebo baseline yielded P values \>0.05|Mixed Models Analysis|||Each dose group was compared to placebo||||>0.05
91641963|NCT03478982|183175282|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
91641964|NCT03478982|183175282|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
91641965|NCT00593385|183175287|OTHER||Meta-Analysis|9.67||||0.005|ONE_SIDED|95.0||16.57||An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.|Exact test of the binomial distribution||To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%|The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.||16.57||0.005
91641966|NCT00924313|183175332|SUPERIORITY||||||<|0.0001||||||The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.|Spearman rank correlation|||||||<0.0001
91641967|NCT00924313|183175332|SUPERIORITY|||||||0.65||||||The reported p-value is representative of the BPH high uptake level.|Spearman rank correlation|||||||0.65
91641968|NCT00924313|183175335|SUPERIORITY|||||||0.55|||||||Spearman rank correlation|||||||0.55
91641969|NCT00924313|183175337|SUPERIORITY|||||||0.407|||||||Spearman rank correlation|||||||0.407
91641970|NCT01353586|183175346|SUPERIORITY_OR_OTHER||Proportion of events|71.6|||||TWO_SIDED|95.0|63.3|79.8|||||The above supplemental analysis is to estimate the rate of subjects without documented symptomatic AF at Day 240 using the Kaplan-Meier time-to-event analysis method to accommodate the censored information from the two withdrawn subjects.|||79.8|63.3|
91641971|NCT03992456|183175354|SUPERIORITY|||||||0.5126|||||||Un-Stratified Log-rank|||||||0.5126
91641972|NCT03992456|183175355|SUPERIORITY|||||||0.1512|||||||Un-Stratified Log-rank|||||||0.1512
91641973|NCT03992456|183175356|SUPERIORITY|||||||0.2506|||||||Chi-squared|||||||0.2506
91486088|NCT01675427|182845273|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0463
91486089|NCT01675427|182845273|SUPERIORITY_OR_OTHER|||||||0.9393|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.9393
91641974|NCT03992456|183175357|SUPERIORITY|||||||0.8865|||||||Chi-squared|||||||0.8865
91641975|NCT03992456|183175358|SUPERIORITY|||||||0.5455|||||||Fisher Exact|||||||0.5455
91641976|NCT04637815|183175369|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables|||||||TWO_SIDED|0.0||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
91486090|NCT01675427|182845273|SUPERIORITY_OR_OTHER|||||||0.3404|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3404
91486091|NCT01675427|182845273|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4237
91486092|NCT01675427|182845274|SUPERIORITY_OR_OTHER|||||||0.251|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2510
91641977|NCT04637815|183175370|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
91641978|NCT04637815|183175371|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
91641979|NCT04637815|183175372|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
91641980|NCT04637815|183175373|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
91641981|NCT00326625|183175374|SUPERIORITY||Slope difference|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.4807|TWO_SIDED|95.0|-0.22|0.1|||ANCOVA||Glatiramer acetate vs. Placebo|Analysis compares the ALSFRS-R slopes of change from baseline between treatment groups. Analysis includes the following covariates: time from randomization, treatment group, time by treatment interaction, center, Riluzole use, age, site of ALS onset, time from ALS onset and baseline ALSFRS-R score.||0.10|-0.22|0.4807
91675284|NCT01383421|183244754|SUPERIORITY||LS Mean Difference|2.728|STANDARD_ERROR_OF_MEAN|1.183||0.021|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.021
91526584|NCT01225822|182928310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7104|TWO_SIDED|95.0|0.55|2.403|||Regression, Logistic|||||2.403|0.550|0.7104
91641982|NCT00326625|183175375|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8583|TWO_SIDED|95.0|0.56|2.005|||Regression, Cox||Glatiramer acetate vs. Placebo|Analysis covariates are center, riluzole use, site of ALS onset, time from ALS onset, baseline ALSFRS-R score, baseline slow vital capacity (VC) and baseline body mass index (BMI).||2.005|0.560|0.8583
91641983|NCT02369874|183175435|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Log Rank|||||1.26|0.85|0.7624
91641984|NCT02369874|183175435|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1993|TWO_SIDED|95.0|0.72|1.08|||Log Rank|||||1.08|0.72|0.1993
91641985|NCT02369874|183175436|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.459|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||||1.17|0.73|0.4590
91641986|NCT02369874|183175436|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.85|1.36||||||||1.36|0.85|
91641987|NCT02369874|183175437|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.63|1.39||||||||1.39|0.63|
91641988|NCT02369874|183175438|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.9|1.33||||||||1.33|0.90|
91641989|NCT02369874|183175438|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.84|1.25||||||||1.25|0.84|
91641990|NCT02369874|183175439|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.67|1.7||||||||1.70|0.67|
91641991|NCT02369874|183175439|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||||1.68|0.66|
91641992|NCT02369874|183175441|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.67|1.52||||||6 Month analysis||1.52|0.67|
91641993|NCT02369874|183175441|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.64|1.46||||||6 Month analysis||1.46|0.64|
91641994|NCT02369874|183175441|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.72|1.75||||||12 Month analysis||1.75|0.72|
91641995|NCT02369874|183175441|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.63|1.57||||||12 Month analysis||1.57|0.63|
91641996|NCT02369874|183175444|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21||||||||1.21|0.76|
91641997|NCT02369874|183175445|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.74|2.39||||||||2.39|0.74|
91641998|NCT00761085|183175545|OTHER|No statistical comparisons||||||||||||||||"No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults"|No statistical comparisons|||
91641999|NCT00761085|183175546|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91642000|NCT05261126|183175586|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-41.2|||<|0.001|TWO_SIDED|95.0|-47.8|-34.7|||cLDA||MK-0616 6 mg minus Placebo|||-34.7|-47.8|<0.001
91642001|NCT05261126|183175586|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.7|||<|0.001|TWO_SIDED|95.0|-62.3|-49.1|||cLDA||MK-0616 12 mg minus Placebo|||-49.1|-62.3|<0.001
91642002|NCT05261126|183175586|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-59.1|||<|0.001|TWO_SIDED|95.0|-65.7|-52.5|||cLDA||MK-0616 18 mg minus Placebo|||-52.5|-65.7|<0.001
91675285|NCT01383421|183244754|SUPERIORITY||LS Mean Difference|3.124|STANDARD_ERROR_OF_MEAN|1.93||0.106|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.106
91642003|NCT05261126|183175586|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-60.9|||<|0.001|TWO_SIDED|95.0|-67.6|-54.3|||cLDA||MK-0616 30 mg minus Placebo|||-54.3|-67.6|<0.001
91642004|NCT05261126|183175587|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-15.5|15.8|||||MK-0616 6 mg minus Placebo|||15.8|-15.5|
91642005|NCT05261126|183175587|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-4.5|||||TWO_SIDED|95.0|-20.0|11.2|||||MK-0616 12 mg vs Placebo|||11.2|-20.0|
91642006|NCT05261126|183175587|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-16.3|15.1|||||MK-0616 18 mg vs Placebo|||15.1|-16.3|
91642007|NCT05261126|183175587|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-17.5|13.8|||||MK-0616 30 mg minus Placebo|||13.8|-17.5|
91642008|NCT05261126|183175589|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-32.8|||<|0.001|TWO_SIDED|95.0|-38.6|-26.9|||cLDA||MK-0616 6 mg minus Placebo|||-26.9|-38.6|<0.001
91642009|NCT05261126|183175589|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-45.8|||<|0.001|TWO_SIDED|95.0|-51.7|-39.9|||cLDA||MK-0616 12 mg minus Placebo|||-39.9|-51.7|<0.001
91486093|NCT01675427|182845274|SUPERIORITY_OR_OTHER|||||||0.2943|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2943
91486094|NCT01675427|182845274|SUPERIORITY_OR_OTHER|||||||0.0478|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0478
91486095|NCT01675427|182845274|SUPERIORITY_OR_OTHER|||||||0.5387|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5387
91486096|NCT01675427|182845274|SUPERIORITY_OR_OTHER|||||||0.3878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3878
91486097|NCT01675427|182845274|SUPERIORITY_OR_OTHER|||||||0.0748|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0748
91675286|NCT01383421|183244754|SUPERIORITY||LS Mean Difference|5.572|STANDARD_ERROR_OF_MEAN|1.756||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.002
91675287|NCT01383421|183244754|SUPERIORITY||LS Mean Difference|1.885|STANDARD_ERROR_OF_MEAN|1.704||0.269|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.269
91675288|NCT01383421|183244755|SUPERIORITY||LS Mean Difference|2.324|STANDARD_ERROR_OF_MEAN|1.177||0.049|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.049
91675289|NCT01383421|183244755|SUPERIORITY||LS Mean Difference|4.929|STANDARD_ERROR_OF_MEAN|1.929||0.011|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.011
91675290|NCT01383421|183244755|SUPERIORITY||LS Mean Difference|5.997|STANDARD_ERROR_OF_MEAN|1.775|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||<0.001
91675291|NCT01383421|183244755|SUPERIORITY||LS Mean Difference|1.823|STANDARD_ERROR_OF_MEAN|1.657||0.272|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.272
91675292|NCT01383421|183244756|SUPERIORITY||LS Mean Difference|0.817|STANDARD_ERROR_OF_MEAN|0.572||0.154|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.154
91675293|NCT01383421|183244756|SUPERIORITY||LS Mean Difference|0.772|STANDARD_ERROR_OF_MEAN|0.599||0.198|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.198
91675294|NCT01383421|183244756|SUPERIORITY||LS Mean Difference|0.884|STANDARD_ERROR_OF_MEAN|0.585||0.131|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.131
91675295|NCT01383421|183244760|SUPERIORITY||LS Mean Between Group Change|0.1|STANDARD_ERROR_OF_MEAN|0.0429||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Necessity||||0.019
91675296|NCT01383421|183244760|SUPERIORITY||LS Mean Between Group Change|0.0|STANDARD_ERROR_OF_MEAN|0.0526||0.56|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Concern||||0.560
91675297|NCT00364949|183244767|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
91675298|NCT00364949|183244768|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
91675299|NCT00364949|183244769|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|||||||0.156
91675300|NCT00364949|183244770|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||t-test, 2 sided|||||||0.770
91675301|NCT00364949|183244771|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||t-test, 2 sided|||||||0.325
91675302|NCT00866658|183244779|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-1.116|-0.65||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%),sulfonylurea use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t test at 5% significance level.||-0.650|-1.116|<0.0001
91675303|NCT01939496|183244849|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-3.29|STANDARD_ERROR_OF_MEAN|1.748||0.062|TWO_SIDED|95.0|-6.743|0.163|||ANCOVA|||||0.163|-6.743|0.062
91675304|NCT01939496|183244849|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-4.93|STANDARD_ERROR_OF_MEAN|1.75||0.006|TWO_SIDED|95.0|-8.382|-1.469|||ANCOVA|||||-1.469|-8.382|0.006
91675305|NCT02274844|183244864|SUPERIORITY|The outcomes were all continuous or ordinal measures, thus unadjusted hypothesis tests used t-tests or the Wilcoxon-Mann-Whitney test, as appropriate, and statistical modeling used linear regression. ANCOVA was used to adjust for baseline covariates with imbalance across treatment arms (race) and baseline values of the measures.|Mean Difference (Final Values)|-0.09||||0.22|TWO_SIDED|95.0|-0.23|0.05||The main hypotheses tested were that intervention participants would have higher medication adherence and significantly greater improvement in A1c, BP, LDL-C, and measures of quality of life, and self-efficacy compared to control participants.|ANCOVA|||The study was powered to detect clinically meaningful differences in physiologic risk factors; it had four primary outcomes.Power estimates accounted for clustering of patients within towns, using a variance inflation factor, conservatively estimating power for ICC=0.01-0.05. Process measures were selected to understand which aspects of the intervention were particularly effective, assessing both program satisfaction and peer coach effectiveness.||0.05|-0.23|0.22
91675306|NCT01642914|183244885|SUPERIORITY_OR_OTHER|||||||0.0054|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0054
91675307|NCT01642914|183244885|SUPERIORITY_OR_OTHER|||||||0.0012|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0012
91642010|NCT05261126|183175589|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-48.7|||<|0.001|TWO_SIDED|95.0|-54.6|-42.8|||cLDA||MK-0616 18 mg minus Placebo|||-42.8|-54.6|<0.001
91716989|NCT04232839|183326240|OTHER||Adjusted geometric mean (gMean) ratio(%)|134.2|||||TWO_SIDED|90.0|117.6|153.0|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||153.0|117.6|
91486098|NCT01675427|182845275|SUPERIORITY_OR_OTHER|||||||0.9887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9887
91642011|NCT05261126|183175589|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Square Means|-51.8|||<|0.001|TWO_SIDED|95.0|-57.7|-45.9|||cLDA||MK-0616 30 mg minus Placebo|||-45.9|-57.7|<0.001
91642012|NCT05261126|183175590|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-35.9|||<|0.001|TWO_SIDED|95.0|-42.4|-29.4|||cLDA||MK-0616 6 mg minus Placebo|||-29.4|-42.4|<0.001
91642013|NCT05261126|183175590|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-50.5|||<|0.001|TWO_SIDED|95.0|-57.0|-44.0|||cLDA||MK-0616 12 mg minus Placebo|||-44.0|-57.0|<0.001
91642014|NCT05261126|183175590|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-53.2|||<|0.001|TWO_SIDED|95.0|-59.7|-46.7|||cLDA||MK-0616 18 mg minus Placebo|||-46.7|-59.7|<0.001
91642015|NCT05261126|183175590|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.8|||<|0.001|TWO_SIDED|95.0|-62.3|-49.3|||cLDA||MK-0616 30 mg minus Placebo|||-49.3|-62.3|<0.001
91642016|NCT05261126|183175591|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|69.2|||<|0.001|TWO_SIDED|95.0|56.2|79.0|||Miettinen & Nurminen||MK-0616 6 mg minus Placebo|||79.0|56.2|<0.001
91642017|NCT05261126|183175591|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|75.2|||<|0.001|TWO_SIDED|95.0|62.9|84.0|||Miettinen & Nurminen method||MK-0616 12 mg minus Placebo|||84.0|62.9|<0.001
91642018|NCT05261126|183175591|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.2|||<|0.001|TWO_SIDED|95.0|67.1|87.1|||Miettinen & Nurminen method||MK-0616 18 mg minus Placebo|||87.1|67.1|<0.001
91642019|NCT05261126|183175591|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.5|||<|0.001|TWO_SIDED|95.0|67.9|87.4|||Miettinen & Nurminen method||MK-0616 30 mg minus Placebo|||87.4|67.9|<0.001
91642020|NCT03901274|183175606|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.74|0.42|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on three month outcomes with intake (i.e. Pretest covariate)||0.42|-0.74|
91675308|NCT01642914|183244898|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.193||||0.0006|TWO_SIDED|95.0|0.086|0.3||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.300|.086|0.0006
91642021|NCT03901274|183175606|SUPERIORITY||Slope|-0.65|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-1.2|-0.09|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on six month outcomes with intake (i.e. Pretest covariate)||-0.09|-1.20|
91675309|NCT01642914|183244898|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.17||||0.0022|TWO_SIDED|95.0|0.064|0.227||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.227|.064|0.0022
91675310|NCT01642914|183244899|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.37||||0.0054|TWO_SIDED|95.0|1.09|1.72|||Log Rank|Log-rank test stratified by geographic region.||||1.72|1.09|.0054
91716990|NCT04232839|183326240|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.8|||||TWO_SIDED|90.0|102.9|128.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.1.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||128.1|102.9|
91716991|NCT04622969|183326252|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.157|<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
91716992|NCT04622969|183326254|SUPERIORITY||Mean Difference (Net)|7.12|STANDARD_ERROR_OF_MEAN|12.05|=|0.56|TWO_SIDED||||||Mixed Models Analysis|||||||=0.56
91486099|NCT01675427|182845275|SUPERIORITY_OR_OTHER|||||||0.5507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5507
91486100|NCT01675427|182845275|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0175
91486101|NCT01675427|182845275|SUPERIORITY_OR_OTHER|||||||0.2246|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2246
91675311|NCT01642914|183244899|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.24||||0.047|TWO_SIDED|95.0|0.99|1.55|||Log Rank|Log-rank test stratified by geographic region.||||1.55|0.99|0.0470
91486102|NCT01675427|182845275|SUPERIORITY_OR_OTHER|||||||0.3519|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3519
91675312|NCT01642914|183244905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.0264|TWO_SIDED|95.0|1.09|4.56||p-values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||4.56|1.09|0.0264
91486103|NCT01675427|182845275|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7140
91486104|NCT01675427|182845276|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8622
91675313|NCT04295135|183244906|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.001|<|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.05
91675314|NCT04295135|183244907|SUPERIORITY||Median Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
91675315|NCT04295135|183244908|SUPERIORITY||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.008|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
91675316|NCT04295135|183244909|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.006|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
91675317|NCT04295135|183244910|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
91486105|NCT01675427|182845276|SUPERIORITY_OR_OTHER|||||||0.1622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1622
91486106|NCT01675427|182845276|SUPERIORITY_OR_OTHER|||||||0.2566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2566
91486107|NCT01675427|182845276|SUPERIORITY_OR_OTHER|||||||0.1574|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1574
91486108|NCT01675427|182845276|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5784
91486109|NCT01675427|182845276|SUPERIORITY_OR_OTHER|||||||0.6603|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6603
91486110|NCT01675427|182845277|SUPERIORITY_OR_OTHER|||||||0.0605|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0605
91486111|NCT01675427|182845277|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0899
91486112|NCT01675427|182845277|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0634
91486113|NCT01675427|182845277|SUPERIORITY_OR_OTHER|||||||0.6165|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.6165
91486114|NCT01675427|182845277|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1649
91486115|NCT01675427|182845277|SUPERIORITY_OR_OTHER|||||||0.9159|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9159
91675318|NCT04295135|183244911|SUPERIORITY||Median Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.003|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
91692181|NCT03296527|183279349|SUPERIORITY|||||||0.159|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Treatment comparison: Average size of 3 largest follicles (mm)||||0.159
91692182|NCT03296527|183279350|SUPERIORITY|||||||0.848|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.848
91692183|NCT03296527|183279350|SUPERIORITY|||||||0.629|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.629
91486116|NCT01675427|182845278|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.7454
91486117|NCT01675427|182845278|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0016
91486118|NCT01675427|182845278|SUPERIORITY_OR_OTHER|||||||0.5261|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5261
91526585|NCT01535274|182928321|SUPERIORITY||||||<|0.001|||||||ANOVA|||P-values represent comparison of successive set points within anesthetic type (i.e.: Set Point 1 compared to Set Point 2, Set Point 2 compared to Set Point 3, etc.). This P-value was determined for each of set points 1, 2, 3, 4, and 5.||||<0.001
91642022|NCT04957979|183175659|SUPERIORITY||Mean Difference (Net)|-1.6||||0.19|TWO_SIDED|95.0|-4.1|0.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||0.1|-4.1|0.19
91642023|NCT04957979|183175659|SUPERIORITY||Mean Difference (Net)|-3.3||||0.005|TWO_SIDED|95.0|-5.6|-1.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||-1.0|-5.6|0.005
91642024|NCT04957979|183175660|SUPERIORITY||Incidence Rate Ratio|1.28||||0.02|TWO_SIDED|95.0|1.04|1.58||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.58|1.04|0.02
91642025|NCT04957979|183175660|SUPERIORITY||Incidence Rate Ratio|1.09||||0.45|TWO_SIDED|95.0|0.868|1.38||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.38|0.868|0.45
91642026|NCT04957979|183175661|SUPERIORITY||Incidence Rate Ratio|1.35||||0.01|TWO_SIDED|95.0|1.08|1.69||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.69|1.08|0.01
91642027|NCT04957979|183175661|SUPERIORITY||Incidence Rate Ratio|1.33||||0.08|TWO_SIDED|95.0|0.969|1.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.81|0.969|0.08
91692184|NCT03296527|183279350|SUPERIORITY|||||||0.768|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average size of 3 largest follicles (mm)||||0.768
91692185|NCT03296527|183279351|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Mean number of oocytes retrieved||||<.001
91692186|NCT03296527|183279353|SUPERIORITY|||||||0.197|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Percentage of MII oocytes / oocytes retrieved||||0.197
91486119|NCT01675427|182845278|SUPERIORITY_OR_OTHER|||||||0.3422|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3422
91486120|NCT01675427|182845278|SUPERIORITY_OR_OTHER|||||||0.9026|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9026
91526586|NCT01905046|182928385|SUPERIORITY||Odds Ratio (OR)|0.97||||0.951|TWO_SIDED|95.0|0.36|2.62|||Chi-squared|||||2.62|0.36|0.951
91675319|NCT02712333|183244953|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|7.53|||<|0.05|TWO_SIDED|95.0|4.65|10.41||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)||10.41|4.65|<0.05
91675320|NCT02712333|183244953|SUPERIORITY_OR_OTHER||fold change|1.33|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
91675321|NCT02712333|183244954|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|3.69|||<|0.01|TWO_SIDED|95.0|1.85|5.54||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum cortisone levels by treatment (intervention group vs control group)||5.54|1.85|<0.01
91675322|NCT02712333|183244954|SUPERIORITY_OR_OTHER||fold change|1.18|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
91675323|NCT02712333|183244955|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|5.17|||<|0.01|TWO_SIDED|95.0|3.21|7.14||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum epinephrine levels by treatment (intervention group vs control group)||7.14|3.21|<0.01
91675324|NCT02712333|183244955|SUPERIORITY_OR_OTHER||fold change|1.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
91675325|NCT02712333|183244956|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|11.28|||<|0.01|TWO_SIDED|95.0|7.37|15.21||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)||15.21|7.37|<0.01
91675326|NCT02712333|183244956|SUPERIORITY_OR_OTHER||fold change|1.57|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
91675327|NCT02712333|183244957|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.84|||<|0.01|TWO_SIDED|95.0|0.09|1.59|||Mixed Models Analysis|||we analyzed the serum SBP levels by treatment (intervention group vs control group)||1.59|0.09|<0.01
91675328|NCT02712333|183244958|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.31|||>|0.05|TWO_SIDED|95.0|-1.59|0.96|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||0.96|-1.59|>0.05
91675329|NCT02712333|183244959|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|1.24|||>|0.05|TWO_SIDED|95.0|-1.14|3.63|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||3.63|-1.14|>0.05
91675330|NCT03463993|183244960|SUPERIORITY|||||||0.549||||||The p-value above is the calculated P value based on hematocrit.|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.549
91675331|NCT03463993|183244960|SUPERIORITY|||||||0.138||||||This is the calculated p-value based on hemoglobin .|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA)10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.138
91675332|NCT03463993|183244961|SUPERIORITY|||||||0.789||||||0.789 is the calculated p-value for visually estimated blood loss: Visually estimated blood loss (ml): Group A mean 483.73 (standard deviation182.56); Group B 479.61 (139.49); p-value 0.789|t-test, 2 sided|||||||0.789
91675333|NCT03463993|183244961|SUPERIORITY|||||||0.968||||||0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968|t-test, 2 sided|||||||0.968
91675334|NCT03463993|183244961|SUPERIORITY|||||||0.447||||||Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447|t-test, 2 sided|||||||0.447
91675335|NCT03463993|183244962|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91675336|NCT03463993|183244963|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91675337|NCT03360916|183244976|SUPERIORITY||Mean Difference (Net)|2.29|STANDARD_DEVIATION|125.59||0.953|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.9530
91675338|NCT03360916|183244976|SUPERIORITY||Mean Difference (Net)|-11.24|STANDARD_DEVIATION|130.12||0.7908|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.7908
91675339|NCT03360916|183244976|SUPERIORITY||Mean Difference (Net)|44.88|STANDARD_DEVIATION|105.19||0.1344|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.1344
91675340|NCT03360916|183244977|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.18||0.0005|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0005
91675341|NCT03360916|183244977|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.21||0.0021|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0021
91675342|NCT03360916|183244977|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.23||0.0025|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0025
91675343|NCT01231373|183244981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-4.63|-2.04|||ANCOVA|||Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.||-2.04|-4.63|<0.0001
91675344|NCT01231373|183244981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.74|||ANCOVA|||||-2.74|-5.26|<0.0001
91675345|NCT01231373|183244981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||<|0.0001|TWO_SIDED|95.0|-4.33|-1.77|||ANCOVA|||||-1.77|-4.33|<0.0001
91675346|NCT01231373|183244982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.88|-0.45|||ANCOVA|||||-0.45|-0.88|<0.0001
91675347|NCT01231373|183244982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.078|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61|||ANCOVA|||||-0.61|-1.04|<0.0001
91675348|NCT01231373|183244982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.54|||ANCOVA|||||-0.54|-0.97|<0.0001
91675349|NCT01231373|183244983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||||-0.87|-1.59|<0.0001
91675350|NCT01231373|183244983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.9|-1.18|||ANCOVA|||||-1.18|-1.90|<0.0001
91675351|NCT01231373|183244983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.83|-1.11|||ANCOVA|||||-1.11|-1.83|<0.0001
91675352|NCT00430950|183245020|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.2648||95.0|-1.51|0.42|||ANCOVA|||"The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.~Significance level alpha = 5%. Power = 80%.~The following statistical superiority hypothesis was tested:~Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg"||0.42|-1.51|0.2648
91675353|NCT00430950|183245021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.4246||95.0|-1.26|0.53|||ANCOVA|||||0.53|-1.26|0.4246
91675354|NCT00430950|183245022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7019||95.0|-1.84|1.24|||ANCOVA||refers to 8 week change; from week 8 to week 16|||1.24|-1.84|0.7019
91675355|NCT00430950|183245022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7328||95.0|-1.71|1.21|||ANCOVA||refers to 4 week change; from week 8 to week 12|||1.21|-1.71|0.7328
91675356|NCT00430950|183245023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0016||95.0|-2.58|-0.6|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.60|-2.58|0.0016
91675357|NCT00430950|183245023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031||95.0|-2.61|-0.53|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.53|-2.61|0.0031
91675358|NCT00430950|183245023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0073||95.0|-2.58|-0.4|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.40|-2.58|0.0073
91675359|NCT00430950|183245023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0021||95.0|-3.71|-0.82|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.82|-3.71|0.0021
91675360|NCT00430950|183245023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0031||95.0|-3.76|-0.76|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.76|-3.76|0.0031
91675361|NCT00430950|183245023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.0104||95.0|-3.61|-0.48|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.48|-3.61|0.0104
91675362|NCT00430950|183245024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||||95.0|0.85|1.4|||Regression, Logistic|||||1.40|0.85|
91675363|NCT01564459|183245033|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.587||||0.269|TWO_SIDED|95.0|-1.637|0.464|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.464|-1.637|0.269
91675364|NCT01564459|183245034|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.687||||0.108|TWO_SIDED|95.0|-1.527|0.154|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.154|-1.527|0.108
91675365|NCT00775684|183245039|SUPERIORITY||||||=|0.1|||||||t-test, 2 sided|||Student t test||||=0.1
91675366|NCT00775684|183245039|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Repeated measure (baseline and 6 months)||||< 0.05
91675367|NCT00775684|183245040|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||Within group changes over 6 months (delta= final - baseline) were compared.||||>0.1
91675368|NCT00775684|183245041|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||To determine if exenatide or sitagliptin induced significant changes from baseline, the change for each measure (Δ = final - baseline) for each group was compared with the change in the glimepiride group using independent Student t tests||||>0.1
91675369|NCT00775684|183245042|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
91692187|NCT03296527|183279354|SUPERIORITY|||||||0.79|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Fertilization rate relative to oocytes retrieved||||0.790
91526587|NCT00405639|182928445|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91526588|NCT00405639|182928446|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91486121|NCT01675427|182845279|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0017
91716993|NCT04622969|183326258|SUPERIORITY||Mean Difference (Net)|0.0015|STANDARD_ERROR_OF_MEAN|0.145|=|0.99|TWO_SIDED||||||Mixed Models Analysis|||||||=0.99
91716994|NCT04622969|183326260|SUPERIORITY||Mean Difference (Net)|-0.264|STANDARD_ERROR_OF_MEAN|0.121|<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
91716995|NCT04622969|183326262|SUPERIORITY||Mean Difference (Net)|-5.573|STANDARD_ERROR_OF_MEAN|1.802|<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
91716996|NCT04622969|183326264|SUPERIORITY||Mean Difference (Net)|3.509|STANDARD_ERROR_OF_MEAN|1.842|=|0.062|TWO_SIDED||||||ANCOVA|||||||=.062
91716997|NCT04622969|183326264|SUPERIORITY||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.17|=|0.78|TWO_SIDED||||||Mixed Models Analysis|||||||=0.78
91716998|NCT01251042|183326269|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Information about the size of the standard deviation (SD) for the change was obtained from an earlier study. The SD for the change from pre-operation until 24 hours after start of transfusion was 0.2305. Due to the imprecise measuring device (if values below 0.3 g/l) and the large SD, a non-inferiority margin (∆) of 0.2 g/l was decided to be used in this study, resulting in a total number of 42 evaluable subjects, i.e. 21 subjects per group.||||||0.6294||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6294
91716999|NCT04249427|183326278|EQUIVALENCE|Test if the change in mean number of days with significant mid-facial pain in Erenuman group differs from that in Placebo group.||||||0.96|||||||ANOVA|||||||0.96
91486122|NCT01675427|182845279|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.8864
91486123|NCT01675427|182845279|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0291
91526589|NCT00405639|182928447|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
91717000|NCT04249427|183326279|EQUIVALENCE|Test if the change in SNOT-22 score in Erenuman group differs from that in Placebo group.||||||0.19|||||||ANOVA|||||||0.19
91486124|NCT01675427|182845279|SUPERIORITY_OR_OTHER|||||||0.5472|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5472
91486125|NCT01675427|182845279|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||1.000
91486126|NCT01675427|182845279|SUPERIORITY_OR_OTHER|||||||0.1148|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.1148
91526590|NCT00405639|182928448|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91717001|NCT04249427|183326280|EQUIVALENCE|Test if the change in Physical Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.06|||||||ANOVA|||||||0.06
91717002|NCT04249427|183326281|EQUIVALENCE|Test if the change in Usual Activities as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91717003|NCT04249427|183326282|EQUIVALENCE|Test if the change in Social Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.058|||||||ANOVA|||||||0.058
91717004|NCT04249427|183326283|EQUIVALENCE|Test if the change in Emotional Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.02|||||||ANOVA|||||||0.02
91717005|NCT04249427|183326284|EQUIVALENCE|Test if the change in Overall Impact (global) as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.0036|||||||ANOVA|||||||0.0036
91717006|NCT04249427|183326285|EQUIVALENCE|Test if the change of average number of days per month with significant nasal congestion in Erenuman group differs from that in Placebo group.||||||0.83|||||||ANOVA|||||||0.83
91717007|NCT04249427|183326286|EQUIVALENCE|Test if the change of average number of days per month with significant significant rhinorrhea in Erenuman group differs from that in Placebo group||||||0.83|||||||ANOVA|||||||0.83
91717008|NCT04249427|183326287|EQUIVALENCE|Test if the change in doses of rescue pain medications in Erenuman group differs from that in Placebo group.||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
91717009|NCT04249427|183326288|EQUIVALENCE|Test if the change from baseline in mean daily pain score in Erenuman group differs from that in Placebo group.||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
91642028|NCT04957979|183175662|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0001|TWO_SIDED|95.0|0.51|0.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||0.81|0.51|0.0001
91642029|NCT04957979|183175662|SUPERIORITY||Odds Ratio (OR)|1.2||||0.32|TWO_SIDED|95.0|0.84|1.72||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.72|0.84|0.32
91642030|NCT04957979|183175663|SUPERIORITY||Odds Ratio (OR)|0.85||||0.14|TWO_SIDED|95.0|0.69|1.05||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.05|0.69|0.14
91642031|NCT04957979|183175663|SUPERIORITY||Odds Ratio (OR)|0.74||||0.12|TWO_SIDED|95.0|0.51|1.08||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.08|0.51|0.12
91642032|NCT04957979|183175664|SUPERIORITY||Odds Ratio (OR)|1.086||||0.914|TWO_SIDED|95.0|0.243|4.861||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.861|0.243|0.914
91642033|NCT04957979|183175664|SUPERIORITY||Odds Ratio (OR)|1.009||||0.987|TWO_SIDED|95.0|0.327|3.114||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||3.114|0.327|0.987
91642034|NCT04957979|183175665|SUPERIORITY||Odds Ratio (OR)|1.257||||0.204|TWO_SIDED|95.0|0.883|1.79||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.79|0.883|0.204
91642035|NCT04957979|183175665|SUPERIORITY||Odds Ratio (OR)|0.399||||0.04|TWO_SIDED|95.0|0.166|0.958|||Mixed Models Analysis|||||0.958|0.166|0.04
91642036|NCT04957979|183175666|SUPERIORITY||Odds Ratio (OR)|1.257||||0.302|TWO_SIDED|95.0|0.814|1.939||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.939|0.814|0.302
91642037|NCT04957979|183175666|SUPERIORITY||Odds Ratio (OR)|0.84||||0.192|TWO_SIDED|95.0|0.647|1.092||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.092|0.647|0.192
91642038|NCT04957979|183175667|SUPERIORITY||Odds Ratio (OR)|0.438||||0.318|TWO_SIDED|95.0|0.086|2.22||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.22|0.086|0.318
91642039|NCT04957979|183175667|SUPERIORITY||Odds Ratio (OR)|1.793||||0.421|TWO_SIDED|95.0|0.433|7.426||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||7.426|0.433|0.421
91642040|NCT04957979|183175668|SUPERIORITY||Odds Ratio (OR)|0.906||||0.632|TWO_SIDED|95.0|0.606|1.356||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.356|0.606|0.632
91675370|NCT02728752|183245047|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.5|-4.6|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16 for Total Activity Score||-4.6|-11.5|<0.0001
91486127|NCT01675427|182845280|SUPERIORITY_OR_OTHER|||||||0.4207|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.4207
91486128|NCT01675427|182845280|SUPERIORITY_OR_OTHER|||||||0.0566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0566
91526591|NCT00612534|182928454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.26|STANDARD_ERROR_OF_MEAN|7.83||0.194||95.0|-5.32|25.83|||ANCOVA|||||25.83|-5.32|0.194
91642041|NCT04957979|183175668|SUPERIORITY||Odds Ratio (OR)|0.845||||0.492|TWO_SIDED|95.0|0.523|1.366||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.366|0.523|0.492
91642042|NCT04957979|183175669|SUPERIORITY||Odds Ratio (OR)|0.856||||0.405|TWO_SIDED|95.0|0.594|1.234||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.234|0.594|0.405
91642043|NCT04957979|183175669|SUPERIORITY||Odds Ratio (OR)|0.559||||0.004|TWO_SIDED|95.0|0.374|0.834|||Mixed Models Analysis|||||0.834|0.374|0.004
91642044|NCT04957979|183175670|SUPERIORITY||Odds Ratio (OR)|0.151||||0.071|TWO_SIDED|95.0|0.02|1.173||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.173|0.02|0.071
91642045|NCT04957979|183175670|SUPERIORITY||Mean Difference (Net)|0.023||||0.003|TWO_SIDED|95.0|0.002|0.268||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||0.268|0.002|0.003
91642046|NCT04957979|183175671|SUPERIORITY||Odds Ratio (OR)|0.884||||0.557|TWO_SIDED|95.0|0.587|1.333||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.333|0.587|0.557
91642047|NCT04957979|183175671|SUPERIORITY||Mean Difference (Net)|0.624||||0.069|TWO_SIDED|95.0|0.376|1.037||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.037|0.376|0.069
91642048|NCT04957979|183175672|SUPERIORITY||Odds Ratio (OR)|0.539||||0.256|TWO_SIDED|95.0|0.185|1.565||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.565|0.185|0.256
91642049|NCT04957979|183175672|SUPERIORITY||Odds Ratio (OR)|1.117||||0.866|TWO_SIDED|95.0|0.308|4.047||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.047|0.308|0.866
91642050|NCT04957979|183175673|SUPERIORITY||Odds Ratio (OR)|0.797||||0.641|TWO_SIDED|95.0|0.307|2.069||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.069|0.307|0.641
91642051|NCT04957979|183175673|SUPERIORITY||Odds Ratio (OR)|0.569||||0.32|TWO_SIDED|95.0|0.187|1.729||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.729|0.187|0.32
91675371|NCT02728752|183245053|SUPERIORITY||Median Difference (Net)|8.6||||0.0001|TWO_SIDED|95.0|4.4|12.8|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||12.8|4.4|0.0001
91486129|NCT01675427|182845280|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1211
91486130|NCT01675427|182845280|SUPERIORITY_OR_OTHER|||||||0.3772|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3772
91526592|NCT00612534|182928454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|STANDARD_ERROR_OF_MEAN|7.77||0.268|TWO_SIDED|95.0|-6.78|24.11|||ANCOVA|||||24.11|-6.78|0.268
91526593|NCT00612534|182928454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.05|STANDARD_ERROR_OF_MEAN|8.3||0.018|TWO_SIDED|95.0|3.54|36.56|||ANCOVA|||||36.56|3.54|0.018
91675372|NCT02728752|183245054|SUPERIORITY||Median Difference (Net)|-0.4||||0.0002|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.2|-0.5|0.0002
91675373|NCT02728752|183245060|SUPERIORITY||Median Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.5|-1.9|0.0010
91675374|NCT02025751|183245064|SUPERIORITY|||||||0.597|||||||ANCOVA|||||||0.597
91675375|NCT00653991|183245070|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91675376|NCT01568866|183245072|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.533|||<|0.0001|TWO_SIDED|95.0|0.437|0.651|||Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|"The PFS interim analysis was to be performed using a group sequential monitoring plan.~The monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025."||0.651|0.437|< 0.0001
91675377|NCT01568866|183245073|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.791||||0.01|TWO_SIDED|95.0|0.648|0.964||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).||0.964|0.648|0.0100
91675378|NCT01568866|183245074|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.032|||<|0.0001|TWO_SIDED|95.0|1.519|2.718||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.|The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|||2.718|1.519|< 0.0001
91675379|NCT01568866|183245076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.089|0.21||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Cochran-Mantel-Haenszel||The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.|||0.210|0.089|<0.0001
91675380|NCT01698775|183245080|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.33||||0.035|TWO_SIDED|95.0|-0.63|-0.02|||ANCOVA|||||-0.02|-0.63|0.035
91526594|NCT01508013|182928465|SUPERIORITY_OR_OTHER|||||||0.633|||||||Mixed Models Analysis|||||||.633
91675381|NCT01698775|183245081|SUPERIORITY_OR_OTHER||Difference in percentages|-3.8|||||TWO_SIDED|95.0|-16.3|8.8|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||8.8|-16.3|
91675382|NCT01698775|183245082|SUPERIORITY_OR_OTHER||Difference in percentages|1.9|||||TWO_SIDED|95.0|-2.6|7.2|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||7.2|-2.6|
91675383|NCT01698775|183245083|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-12.2|10.3|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||10.3|-12.2|
91675384|NCT01698775|183245084|SUPERIORITY_OR_OTHER||Difference in percentage|2.8|||||TWO_SIDED|95.0|-3.6|9.8||||||||9.8|-3.6|
91675385|NCT01698775|183245085|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.9||||0.54|TWO_SIDED|95.0|-16.5|8.7|||ANCOVA|||||8.7|-16.5|0.540
91675386|NCT01698775|183245088|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.72|TWO_SIDED|95.0|-2.7|1.9|||cLDA|||||1.9|-2.7|0.720
91526595|NCT01508013|182928466|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
91526596|NCT01508013|182928467|SUPERIORITY_OR_OTHER|||||||0.018|||||||Mixed Models Analysis|||||||.018
91526597|NCT01279343|182928505|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.03|TWO_SIDED|95.0|-5.9|-0.3|||t-test, 2 sided|||||-0.3|-5.9|0.03
91526598|NCT01279343|182928506|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.23|||Chi-squared|||Comparison of vaginal delivery between groups.||1.23|.80|0.96
91526599|NCT01279343|182928506|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.57|1.9|||Chi-squared|||Cesarean deliveries were compared between the groups.||1.90|0.57|0.90
91675387|NCT03864042|183245090|OTHER||Geometric LS Mean Ratio|1.17|||||TWO_SIDED|90.0|0.978|1.4|||||Day 1 / Day -7|||1.40|0.978|
91675388|NCT03864042|183245090|OTHER||Geometric LS Mean Ratio|0.258|||||TWO_SIDED|90.0|0.215|0.308|||||Day 14 / Day -7|||0.308|0.215|
91675389|NCT03864042|183245091|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|0.998|1.25|||||Day 1 / Day -7|||1.25|0.998|
91675390|NCT03864042|183245091|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.12|1.4|||||Day 14 / Day -7|||1.40|1.12|
91675391|NCT03864042|183245092|OTHER||Geometric LS Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.62|||||Day 1 / Day -7|||1.62|1.12|
91675392|NCT03864042|183245092|OTHER||Geometric LS Mean Ratio|0.622|||||TWO_SIDED|90.0|0.517|0.748|||||Day 14 / Day -7|||0.748|0.517|
91675393|NCT03864042|183245093|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.975|1.23|||||Day 1 / Day -7|||1.23|0.975|
91675394|NCT03864042|183245093|OTHER||Geometric LS Mean Ratio|1.3|||||TWO_SIDED|90.0|1.16|1.46|||||Day 14 / Day -7|||1.46|1.16|
91675395|NCT03864042|183245094|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.922|1.2|||||Day 1 / Day -7|||1.20|0.922|
91675396|NCT03864042|183245094|OTHER||Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|0.992|1.29|||||Day 14 / Day -7|||1.29|0.992|
91675397|NCT03864042|183245095|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.19|||||Day 1 / Day -7|||1.19|0.990|
91675398|NCT03864042|183245095|OTHER||Geometric LS Mean Ratio|1.1|||||TWO_SIDED|90.0|1.0|1.22|||||Day 14 / Day -7|||1.22|1.00|
91675399|NCT03864042|183245096|OTHER||Geometric LS Mean Ratio|0.894|||||TWO_SIDED|90.0|0.741|1.08|||||Day 1 / Day -7|||1.08|0.741|
91675400|NCT03864042|183245096|OTHER||Geometric LS Mean Ratio|0.692|||||TWO_SIDED|90.0|0.573|0.835|||||Day 14 / Day -7|||0.835|0.573|
91675401|NCT03864042|183245097|OTHER||Geometric LS Mean Ratio|1.32|||||TWO_SIDED|90.0|0.861|2.04|||||Day 1 / Day -7|||2.04|0.861|
91675402|NCT03864042|183245097|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.659|1.56|||||Day 14 / Day -7|||1.56|0.659|
91675403|NCT03864042|183245098|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.762|1.33|||||Day 1 / Day -7|||1.33|0.762|
91675404|NCT03864042|183245098|OTHER||Geometric LS Mean Ratio|0.718|||||TWO_SIDED|90.0|0.543|0.948|||||Day 14 / Day -7|||0.948|0.543|
91675405|NCT03864042|183245099|OTHER||Geometric LS Mean Ratio|4.34|||||TWO_SIDED|90.0|2.94|6.4|||||Day 1 / Day -7|||6.40|2.94|
91675406|NCT03864042|183245099|OTHER||Geometric LS Mean Ratio|2.68|||||TWO_SIDED|90.0|1.82|3.96|||||Day 14 / Day -7|||3.96|1.82|
91675407|NCT03864042|183245100|OTHER||Geometric LS Mean Ratio|0.754|||||TWO_SIDED|90.0|0.595|0.954|||||Day 1 / Day -7|||0.954|0.595|
91486131|NCT01675427|182845280|SUPERIORITY_OR_OTHER|||||||0.4023|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4023
91486132|NCT01675427|182845281|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91486133|NCT01675427|182845281|SUPERIORITY_OR_OTHER|||||||0.2132|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2132
91526600|NCT03287414|182928515|SUPERIORITY||Least Squares Mean Difference|0.063|STANDARD_ERROR_OF_MEAN|0.1379||0.3248|TWO_SIDED|80.0|-0.115|0.241||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.241|-0.115|0.3248
91526601|NCT03287414|182928516|OTHER|||||||0.868|||||||Log Rank|||||||0.868
91526602|NCT03287414|182928518|OTHER||Hazard Ratio (HR)|2.6||||0.921|TWO_SIDED|80.0|1.1|6.3|||Log Rank|||PFS1||6.3|1.1|0.921
91526603|NCT03287414|182928518|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||PFS2||5.6|0.9|0.863
91675408|NCT03864042|183245100|OTHER||Geometric LS Mean Ratio|0.755|||||TWO_SIDED|90.0|0.596|0.957|||||Day 14 / Day -7|||0.957|0.596|
91675409|NCT03864042|183245101|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.864|1.27|||||Day 1 / Day -7|||1.27|0.864|
91675410|NCT03864042|183245101|OTHER||Geometric LS Mean Ratio|1.42|||||TWO_SIDED|90.0|1.17|1.72|||||Day 14 / Day -7|||1.72|1.17|
91675411|NCT03864042|183245102|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.92|1.25|||||Day 1 / Day -7|||1.25|0.920|
91675412|NCT03864042|183245102|OTHER||Geometric LS Mean Ratio|0.175|||||TWO_SIDED|90.0|0.151|0.204|||||Day 14 / Day -7|||0.204|0.151|
91675413|NCT03864042|183245103|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.18|1.38|||||Day 1 / Day -7|||1.38|1.18|
91675414|NCT03864042|183245103|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.974|1.14|||||Day 14 / Day -7|||1.14|0.974|
91675415|NCT03864042|183245104|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.09|1.43|||||Day 1 / Day -7|||1.43|1.09|
91675416|NCT03864042|183245104|OTHER||Geometric LS Mean Ratio|0.513|||||TWO_SIDED|90.0|0.449|0.587|||||Day 14 / Day -7|||0.587|0.449|
91675417|NCT03864042|183245105|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.17|1.39|||||Day 1 / Day -7|||1.39|1.17|
91675418|NCT03864042|183245105|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.979|1.16|||||Day 14 / Day -7|||1.16|0.979|
91675419|NCT03864042|183245106|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.947|1.26|||||Day 1 / Day -7|||1.26|0.947|
91675420|NCT03864042|183245106|OTHER||Geometric LS Mean Ratio|1.27|||||TWO_SIDED|90.0|1.1|1.46|||||Day 14 / Day -7|||1.46|1.10|
91675421|NCT03864042|183245107|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23|||||Day 1 / Day -7|||1.23|1.02|
91675422|NCT03864042|183245107|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|1.14|1.38|||||Day 14 / Day -7|||1.38|1.14|
91675423|NCT03864042|183245108|OTHER||Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.721|1.12|||||Day 1 / Day -7|||1.12|0.721|
91675424|NCT03864042|183245108|OTHER||Geometric LS Mean Ratio|0.679|||||TWO_SIDED|90.0|0.544|0.848|||||Day 14 / Day -7|||0.848|0.544|
91675425|NCT03864042|183245109|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|0.8|1.98|||||Day 1 / Day -7|||1.98|0.800|
91675426|NCT03864042|183245109|OTHER||Geometric LS Mean Ratio|0.827|||||TWO_SIDED|90.0|0.526|1.3|||||Day 14 / Day -7|||1.30|0.526|
91675427|NCT03864042|183245110|OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.688|1.39|||||Day 1 / Day -7|||1.39|0.688|
91675428|NCT03864042|183245110|OTHER||Geometric LS Mean Ratio|0.633|||||TWO_SIDED|90.0|0.445|0.9|||||Day 14 / Day -7|||0.900|0.445|
91675429|NCT03864042|183245111|OTHER||Geometric LS Mean Ratio|2.79|||||TWO_SIDED|90.0|2.08|3.74|||||Day 1 / Day -7|||3.74|2.08|
91675430|NCT03864042|183245111|OTHER||Geometric LS Mean Ratio|1.57|||||TWO_SIDED|90.0|1.17|2.11|||||Day 14 / Day -7|||2.11|1.17|
91675431|NCT03864042|183245112|OTHER||Geometric LS Mean Ratio|0.769|||||TWO_SIDED|90.0|0.637|0.928|||||Day 1 / Day -7|||0.928|0.637|
91675432|NCT03864042|183245112|OTHER||Geometric LS Mean Ratio|0.736|||||TWO_SIDED|90.0|0.61|0.889|||||Day 14 / Day -7|||0.889|0.610|
91675433|NCT03864042|183245113|OTHER||Geometric LS Mean Ratio|0.993|||||TWO_SIDED|90.0|0.803|1.23|||||Day 1 / Day -7|||1.23|0.803|
91675434|NCT03864042|183245113|OTHER||Geometric LS Mean Ratio|1.48|||||TWO_SIDED|90.0|1.2|1.83|||||Day 14 / Day -7|||1.83|1.20|
91675435|NCT03864042|183245114|OTHER||Geometric LS Mean Ratio|1.45|||||TWO_SIDED|90.0|0.902|2.32|||||Day 1 / Day -7|||2.32|0.902|
91675436|NCT03864042|183245114|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.72|1.93|||||Day 14 / Day -7|||1.93|0.720|
91675437|NCT03864042|183245115|OTHER||Geometric LS Mean Ratio|1.47|||||TWO_SIDED|90.0|0.915|2.36|||||Day 1 / Day -7|||2.36|0.915|
91675438|NCT03864042|183245115|OTHER||Geometric LS Mean Ratio|0.851|||||TWO_SIDED|90.0|0.519|1.39|||||Day 14 / Day -7|||1.39|0.519|
91486134|NCT01675427|182845281|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
91486135|NCT01675427|182845281|SUPERIORITY_OR_OTHER|||||||0.3031|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3031
91675439|NCT03864042|183245116|OTHER||Geometric LS Mean Ratio|1.2|||||TWO_SIDED|90.0|0.775|1.87|||||Day 1 / Day -7|||1.87|0.775|
91675440|NCT03864042|183245116|OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.593|1.49|||||Day 14 / Day -7|||1.49|0.593|
91675441|NCT03864042|183245117|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||Day 1 / Day -7|||1.67|0.830|
91675442|NCT03864042|183245117|OTHER||Geometric LS Mean Ratio|0.979|||||TWO_SIDED|90.0|0.68|1.41|||||Day 14 / Day -7|||1.41|0.680|
91675443|NCT03864042|183245118|OTHER||Geometric LS Mean Ratio|0.798|||||TWO_SIDED|90.0|0.585|1.09|||||Day 21 / Day 14|||1.09|0.585|
91675444|NCT03864042|183245119|OTHER||Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.935|1.11|||||Day 21 / Day 14|||1.11|0.935|
91675445|NCT03864042|183245120|OTHER||Geometric LS Mean Ratio|0.762|||||TWO_SIDED|90.0|0.613|0.945|||||Day 21 / Day 14|||0.945|0.613|
91675446|NCT03864042|183245121|OTHER||Geometric LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.929|1.22|||||Day 21 / Day 14|||1.22|0.929|
91675447|NCT00515034|183245271|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|-13.8|||||TWO_SIDED|95.0|-54.4|26.8|||normal approximation to the binomial||Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are provided.||26.8|-54.4|
91486136|NCT01675427|182845281|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9550
91486137|NCT01675427|182845281|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91526604|NCT03287414|182928519|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||FVC||5.6|0.9|0.863
91486138|NCT01675427|182845282|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91486139|NCT01675427|182845282|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1890
91486140|NCT01675427|182845282|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5793
91486141|NCT01675427|182845282|SUPERIORITY_OR_OTHER|||||||0.0847|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0847
91486142|NCT01675427|182845282|SUPERIORITY_OR_OTHER|||||||0.5506|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5506
91526605|NCT03287414|182928519|OTHER||Hazard Ratio (HR)|0.9||||0.457|TWO_SIDED|80.0|0.4|2.0|||Log Rank|||DLCO||2.0|0.4|0.457
91526606|NCT03287414|182928519|OTHER||Hazard Ratio (HR)|0.3||||0.019|TWO_SIDED|80.0|0.1|0.6|||Log Rank|||6MWD||0.6|0.1|0.019
91675448|NCT00515034|183245272|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|18.7|||||TWO_SIDED|95.0|-13.2|50.6|||normal approximation to binomial||Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are presented.||50.6|-13.2|
91675449|NCT00605865|183245325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||<0.001
91675450|NCT00605865|183245326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.039
91675451|NCT00605865|183245327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.011
91675452|NCT00605865|183245328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||0.010
91675453|NCT00605865|183245329|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
91675454|NCT00605865|183245330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders."||||0.014
91675455|NCT00605865|183245331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.021
91675456|NCT00605865|183245332|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders."||||<0.001
91692188|NCT03296527|183279355|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of embryos on day 3||||<.001
91692189|NCT03296527|183279355|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of good-quality embryos on Day 3||||<.001
91675457|NCT00605865|183245333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders."||||0.003
91675458|NCT00605865|183245334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders."||||0.012
91675459|NCT00605865|183245335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.019
91675460|NCT00605865|183245336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.010
91675461|NCT00605865|183245337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders."||||0.015
91675462|NCT00605865|183245338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders."||||<0.001
91675463|NCT02856880|183245366|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|40.18|||<|0.0001|TWO_SIDED|95.0|32.37|47.99||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque Glycolysis for the first named treatment.|||47.99|32.37|<0.0001
91675464|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|26.41|||<|0.0001|TWO_SIDED|95.0|18.94|33.88||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||33.88|18.94|<0.0001
91675465|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|-2.91||||0.4823|TWO_SIDED|95.0|-11.18|5.37||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment.|||5.37|-11.18|0.4823
91675466|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|10.86||||0.0072|TWO_SIDED|95.0|3.13|18.59||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||18.59|3.13|0.0072
91675467|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|13.77||||0.0009|TWO_SIDED|95.0|6.01|21.53||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||21.53|6.01|0.0009
91675468|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|8.44||||0.0286|TWO_SIDED|95.0|0.93|15.95||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||15.95|0.93|0.0286
91675469|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|5.32||||0.1573|TWO_SIDED|95.0|-2.15|12.79||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||12.79|-2.15|0.1573
91675470|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|-29.32|||<|0.0001|TWO_SIDED|95.0|-37.2|-21.43||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||-21.43|-37.20|<0.0001
91675471|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|31.74|||<|0.0001|TWO_SIDED|95.0|24.18|39.3||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||39.30|24.18|<0.0001
91675472|NCT02856880|183245367|SUPERIORITY_OR_OTHER||LS mean difference|2.42||||0.5174|TWO_SIDED|95.0|-5.08|9.92||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||9.92|-5.08|0.5174
91675473|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-233.22|||<|0.0001|TWO_SIDED|95.0|-332.88|-133.55||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-133.55|-332.88|<0.0001
91675474|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|35.53||||0.5018|TWO_SIDED|95.0|-69.9|140.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||140.96|-69.90|0.5018
91675475|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-24.73||||0.6325|TWO_SIDED|95.0|-128.07|78.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||78.61|-128.07|0.6325
91675476|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-60.26||||0.2427|TWO_SIDED|95.0|-162.72|42.21||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||42.21|-162.72|0.2427
91675477|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|1.05||||0.9834|TWO_SIDED|95.0|-100.5|102.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||102.61|-100.50|0.9834
91675478|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-61.31||||0.2226|TWO_SIDED|95.0|-161.14|38.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||38.52|-161.14|0.2226
91675479|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|268.74|||<|0.0001|TWO_SIDED|95.0|165.98|371.51||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque|||371.51|165.98|<0.0001
91675480|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-293.47|||<|0.0001|TWO_SIDED|95.0|-396.03|-190.91||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-190.91|-396.03|<0.0001
91675481|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-294.53|||<|0.0001|TWO_SIDED|95.0|-395.43|-193.62||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-193.62|-395.43|<0.0001
91642052|NCT04957979|183175674|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.001|TWO_SIDED|95.0|5.6|13.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||13|5.6|<.001
91642053|NCT04957979|183175674|SUPERIORITY||Risk Difference (RD)|11.0||||0.002|TWO_SIDED|95.0|4.2|18.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||18|4.2|0.002
91642054|NCT04957979|183175675|SUPERIORITY||Risk Difference (RD)|6.0||||0.023|TWO_SIDED|95.0|0.86|11.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||11.0|0.86|0.023
91642055|NCT04957979|183175675|SUPERIORITY||Risk Difference (RD)|-3.7||||0.5|TWO_SIDED|95.0|-14.0|7.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||7.0|-14.0|0.5
91642056|NCT04957979|183175676|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.06|0.19||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.19|0.06|<0.001
91642057|NCT04957979|183175676|SUPERIORITY||Mean Difference (Net)|0.19|||<|0.001|TWO_SIDED|95.0|0.06|0.32||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.32|0.06|<0.001
91642058|NCT04957979|183175677|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.06|||t-test, 2 sided|No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.06|-0.16|<0.001
91642059|NCT04957979|183175677|SUPERIORITY||Mean Difference (Net)|-0.11||||0.006|TWO_SIDED|95.0|-0.2|-0.03|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.03|-0.2|0.006
91642060|NCT04957979|183175678|SUPERIORITY||Risk Difference (RD)|-2.4||||0.059|TWO_SIDED|95.0|-4.9|0.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||0.00|-4.9|0.059
91642061|NCT04957979|183175678|SUPERIORITY||Risk Difference (RD)|-5.7||||0.014|TWO_SIDED|95.0|-10.0|-1.3||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.3|-10.0|0.014
91642062|NCT04957979|183175679|SUPERIORITY||Risk Difference (RD)|11.0|||<|0.001|TWO_SIDED|95.0|6.8|15.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||15.0|6.8|<0.001
91642063|NCT04957979|183175679|SUPERIORITY||Risk Difference (RD)|12.0||||0.001|TWO_SIDED|95.0|4.7|20.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||20.0|4.7|0.001
91642064|NCT04957979|183175680|SUPERIORITY||Mean Difference (Net)|-7.6|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5|-10|<.001
91642065|NCT04957979|183175680|SUPERIORITY||Mean Difference (Net)|-6.0||||0.007|TWO_SIDED|95.0|-10.0|-2.0|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-2|-10|0.007
91675482|NCT02856880|183245368|SUPERIORITY_OR_OTHER||LS mean difference|-25.78||||0.6086|TWO_SIDED|95.0|-126.53|74.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||74.96|-126.53|0.6086
91675483|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|-273.92||||0.6664|TWO_SIDED|95.0|-1550.45|1002.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1002.61|-1550.45|0.6664
91675484|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|674.06||||0.3249|TWO_SIDED|95.0|-692.21|2040.33||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2040.33|-692.21|0.3249
91642066|NCT04957979|183175681|SUPERIORITY||Risk Difference (RD)|-2.5||||0.046|TWO_SIDED|95.0|-4.8|-0.14||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.14|-4.8|0.046
91642067|NCT04957979|183175681|SUPERIORITY||Risk Difference (RD)|-4.5||||0.033|TWO_SIDED|95.0|-8.4|-0.52||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.52|-8.4|0.033
91642068|NCT04957979|183175682|SUPERIORITY||Risk Difference (RD)|-10.0|||<|0.001|TWO_SIDED|95.0|-13.0|-6.8||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-6.8|-13.0|<0.001
91642069|NCT04957979|183175682|SUPERIORITY||Risk Difference (RD)|-11.0|||<|0.001|TWO_SIDED|95.0|-17.0|-5.6||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5.6|-17.0|<0.001
91642070|NCT04957979|183175683|SUPERIORITY||Risk Difference (RD)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.0|-4.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-4.1|-10.0|<0.001
91675485|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|677.09||||0.3544|TWO_SIDED|95.0|-784.16|2138.35||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2138.35|-784.16|0.3544
91675486|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|3.04||||0.9967|TWO_SIDED|95.0|-1469.45|1475.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1475.52|-1469.45|0.9967
91675487|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|766.64||||0.2976|TWO_SIDED|95.0|-703.26|2236.54||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2236.54|-703.26|0.2976
91675488|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|-763.6||||0.2702|TWO_SIDED|95.0|-2144.45|617.25||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||617.25|-2144.45|0.2702
91675489|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|947.97||||0.1511|TWO_SIDED|95.0|-361.95|2257.9||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2257.90|-361.95|0.1511
91642071|NCT04957979|183175683|SUPERIORITY||Risk Difference (RD)|-8.2||||0.002|TWO_SIDED|95.0|-13.0|-3.2||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social|||-3.2|-13.0|0.002
91642072|NCT04957979|183175684|SUPERIORITY||Risk Difference (RD)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.4|-5.5|0.002
91642073|NCT04957979|183175684|SUPERIORITY||Risk Difference (RD)|-2.4||||0.3|TWO_SIDED|95.0|-6.1|1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||1.4|-6.1|0.3
91642074|NCT03671746|183175685|SUPERIORITY||Median Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|=|0.275|TWO_SIDED||||||ANOVA|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using Length of Stay (LOS) as this was the primary outcome. Using a significance level of 0.05 and assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||=0.275
91675490|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|-270.88||||0.6998|TWO_SIDED|95.0|-1680.58|1138.82||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1138.82|-1680.58|0.6998
91675491|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|-1037.52||||0.121|TWO_SIDED|95.0|-2361.33|286.29||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||286.29|-2361.33|0.1210
91675492|NCT02856880|183245369|SUPERIORITY_OR_OTHER||LS mean difference|-89.54||||0.8935|TWO_SIDED|95.0|-1439.5|1260.41||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1260.41|-1439.50|0.8935
91675493|NCT00094458|183245370|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
91526607|NCT03287414|182928520|OTHER||Hazard Ratio (HR)|1.1||||0.611|TWO_SIDED|80.0|0.6|2.0|||Log Rank|||Composite Endpoint 1||2.0|0.6|0.611
91526608|NCT03287414|182928520|OTHER||Hazard Ratio (HR)|1.1||||0.549|TWO_SIDED|80.0|0.6|1.9|||Log Rank|||Composite Endpoint 2||1.9|0.6|0.549
91526609|NCT03287414|182928521|SUPERIORITY||Least Squares of the Mean|-0.92|STANDARD_ERROR_OF_MEAN|1.3109||0.7576|TWO_SIDED|80.0|-2.615|0.774||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.774|-2.615|0.7576
91526610|NCT03287414|182928522|SUPERIORITY||Least Squares of the Mean|32.222|STANDARD_ERROR_OF_MEAN|61.8632||0.3018|TWO_SIDED|80.0|-47.572|112.015||1-sided p-values were obtained using MMRM Model.|MMRM|||||112.015|-47.572|0.3018
91526611|NCT03287414|182928523|SUPERIORITY||Least Squares of the Mean|29.166|STANDARD_ERROR_OF_MEAN|60.0143||0.314|TWO_SIDED|80.0|-48.22|106.553||1-sided p-values were obtained using MMRM Model.|MMRM|||||106.553|-48.220|0.3140
91526612|NCT03287414|182928524|SUPERIORITY||Least Squares of the mean|1.77|STANDARD_ERROR_OF_MEAN|1.5422||0.1269|TWO_SIDED|80.0|-0.219|3.759||1-sided p-values were obtained using MMRM Model.|MMRM|||||3.759|-0.219|0.1269
91526613|NCT01353222|182928540|SUPERIORITY||Hazard Ratio (HR)|1.141||||0.6188|TWO_SIDED|95.0|0.679|1.918|||From a stratified log-rank test, stratif||Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.|||1.918|0.679|0.6188
91526614|NCT00045435|182928543|OTHER||Percent|47.0|||||ONE_SIDED|95.0||69.0|||||The criterion for stopping was not met.|The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was \<35%.||69||
91526615|NCT00045435|182928544|OTHER||percent|6.0|||||ONE_SIDED|80.0|1.0||||||The stopping criterion was not met.|The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%|||1|
91526616|NCT03621202|182928559|OTHER||||||||||||||||||The EBBMS sensitivity was 100%.|||
91526617|NCT03621202|182928560|OTHER||||||||||||||||||The EBBMS specificity was 75%.|||
91526618|NCT00663117|182928568|SUPERIORITY_OR_OTHER|||||||0.009||||||The percentage of subjects achieving a 70-point drop in CDAI score in naltrexone treated subjects was the percentage acheiving the same drop in the placebo controls|Fisher Exact|||The proportion of those achieving a response with a 70-point decline in CDAI score was compared between naltrexone and placebo treated subjects using the Fisher's exact test. Analysis was performed with the intent-to-treat criteria. Clinical significance was accepted if the difference met 95% confidence (p\<0.05).||||0.009
91526619|NCT00663117|182928570|SUPERIORITY_OR_OTHER|||||||0.008|ONE_SIDED|95.0|||||Fisher Exact|||Percentage of patients having a 5-point decline in the endoscopic inflammation score||||0.008
91526620|NCT00663117|182928571|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 1 sided|||||||0.048
91526621|NCT00437125|182928608|SUPERIORITY_OR_OTHER||Percentage|8.6|||||ONE_SIDED|95.0||13.3||||||||13.3||
91526622|NCT00437125|182928609|SUPERIORITY_OR_OTHER|||||||0.5553||95.0||||p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.||||0.5553
91526623|NCT00437125|182928610|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for psychic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.||||<0.0001
91526624|NCT00437125|182928610|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for neurological subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.||||<0.0001
91526625|NCT00437125|182928610|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||p-value is for autonomic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.||||0.0014
91526626|NCT00437125|182928610|SUPERIORITY_OR_OTHER|||||||0.5586||95.0||||p-value is for other subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.||||0.5586
91526627|NCT00437125|182928610|SUPERIORITY_OR_OTHER|||||||0.0848||95.0||||p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.||||0.0848
91526628|NCT00437125|182928610|SUPERIORITY_OR_OTHER|||||||0.0263||95.0||||p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.||||0.0263
91526629|NCT00437125|182928611|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 4 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.||||<0.0001
91526630|NCT00437125|182928611|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 8 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.||||<0.0001
91526631|NCT00437125|182928611|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 12 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.||||<0.0001
91526632|NCT00437125|182928612|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.||||<0.0001
91526633|NCT00437125|182928613|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.||||<0.0001
91642075|NCT03671746|183175686|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using LOS as this was the primary outcome. Using a significance level of 0.05 and an assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
91642076|NCT03671746|183175687|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|The VAS model was adjusted for baseline levels as a covariate, which differed significantly between groups.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
91642077|NCT03671746|183175688|SUPERIORITY||||||=|0.564|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.564
91675494|NCT00094458|183245370|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.006
91675495|NCT00094458|183245370|SUPERIORITY_OR_OTHER|||||||0.022|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.022
91675496|NCT00094458|183245371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
91675497|NCT00094458|183245371|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.023
91675498|NCT00094458|183245371|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.055
91675499|NCT03247517|183245379|SUPERIORITY||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0232|TWO_SIDED|95.0|-8.4|-0.6|||Mixed Models for Repeated Measures|||||-0.6|-8.4|0.0232
91675500|NCT03247517|183245379|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0091|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Models for Repeated Measures|||||-1.3|-8.9|0.0091
91675501|NCT03247517|183245380|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0042|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0042
91675502|NCT03247517|183245380|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.9|0.0003
91675503|NCT03247517|183245381|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.54||0.6854|TWO_SIDED|95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.6854
91675504|NCT03247517|183245381|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.49||0.0518|TWO_SIDED|95.0|-5.8|0.0|||ANCOVA|||||0.0|-5.8|0.0518
91675505|NCT03247517|183245382|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.2062|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.2062
91675506|NCT03247517|183245382|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0519|TWO_SIDED|95.0|-0.23|0.0|||ANCOVA|||||0.00|-0.23|0.0519
91675507|NCT03247517|183245383|SUPERIORITY||Risk Difference (RD)|18.8||||0.0068|TWO_SIDED|95.0|5.5|32.2|||Regression, Logistic|||||32.2|5.5|0.0068
91675508|NCT03247517|183245383|SUPERIORITY||Risk Difference (RD)|17.6||||0.0095|TWO_SIDED|95.0|4.6|30.5|||Regression, Logistic|||||30.5|4.6|0.0095
91675509|NCT03247517|183245384|SUPERIORITY||Least Square Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.51||0.7629|TWO_SIDED|95.0|-9.1|12.5|||ANCOVA|||||12.5|-9.1|0.7629
91675510|NCT03247517|183245384|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.36||0.7648|TWO_SIDED|95.0|-12.1|8.9|||ANCOVA|||||8.9|-12.1|0.7648
91675511|NCT03247517|183245385|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.99||0.0069|TWO_SIDED|95.0|-4.6|-0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.7|-4.6|0.0069
91675512|NCT03247517|183245385|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.96||0.0005|TWO_SIDED|95.0|-5.2|-1.5|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.5|-5.2|0.0005
91675513|NCT03247517|183245385|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.05||0.0424|TWO_SIDED|95.0|-4.2|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.2|0.0424
91675514|NCT03247517|183245385|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.039|TWO_SIDED|95.0|-4.1|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.1|0.0390
91642078|NCT03671746|183175689|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.118
91642079|NCT03671746|183175690|SUPERIORITY|||||||0.215|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||0.215
91526634|NCT00437125|182928615|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for BDI score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores||||<0.0001
91526635|NCT00437125|182928616|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.||||0.0027
91526636|NCT00437125|182928616|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.||||0.0002
91642080|NCT03671746|183175691|SUPERIORITY||||||=|0.043|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.043
91642081|NCT03671746|183175692|SUPERIORITY||||||=|0.617|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.617
91675515|NCT03247517|183245386|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3813|TWO_SIDED|95.0|-3.4|1.3|||ANCOVA|||||1.3|-3.4|0.3813
91675516|NCT03247517|183245386|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.17||0.9506|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA|||||2.2|-2.4|0.9506
91675517|NCT03247517|183245387|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 1||||0.0254
91526637|NCT00437125|182928616|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.||||<0.0001
91642082|NCT03671746|183175694|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||<0.05
91642083|NCT04410991|183175751|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|0.996||||0.9758|TWO_SIDED|95.0|0.754|1.315||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.315|0.754|0.9758
91642084|NCT04410991|183175752|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.582||||0.0114|TWO_SIDED|95.0|0.38|0.891||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.891|0.380|0.0114
91642085|NCT04410991|183175753|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.641||||0.0181|TWO_SIDED|95.0|0.444|0.925||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.925|0.444|0.0181
91642086|NCT04410991|183175754|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.165||||0.2362|TWO_SIDED|95.0|0.905|1.502|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.502|0.905|0.2362
91642087|NCT04410991|183175755|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|2.118|||<|0.0001|TWO_SIDED|95.0|1.502|2.987|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.987|1.502|<0.0001
91642088|NCT04410991|183175756|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|-0.053||||0.31|TWO_SIDED|95.0|-0.156|0.05|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.050|-0.156|0.3100
91642089|NCT04410991|183175757|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|-0.612||||0.5235|TWO_SIDED|95.0|-2.493|1.269|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||1.269|-2.493|0.5235
91642090|NCT04410991|183175758|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|1.652||||0.0079|TWO_SIDED|95.0|1.145|2.383||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||2.383|1.145|0.0079
91642091|NCT04410991|183175759|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.044||||0.4266|TWO_SIDED|95.0|-0.065|0.153|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.153|-0.065|0.4266
91675518|NCT03247517|183245387|SUPERIORITY|||||||0.0899|||||||Chi-squared|||This analysis pertains to Week 2||||0.0899
91675519|NCT03247517|183245387|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 3||||0.0070
91675520|NCT03247517|183245387|SUPERIORITY|||||||0.0031|||||||Chi-squared|||This analysis pertains to Week 4||||0.0031
91526638|NCT00437125|182928616|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.||||<0.0001
91675521|NCT03247517|183245387|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 5||||0.0065
91675522|NCT03247517|183245387|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 6||||0.0070
91675523|NCT03247517|183245387|SUPERIORITY|||||||0.0063|||||||Chi-squared|||This analysis pertains to Week 1||||0.0063
91675524|NCT03247517|183245387|SUPERIORITY|||||||0.0123|||||||Chi-squared|||This analysis pertains to Week 2||||0.0123
91675525|NCT03247517|183245387|SUPERIORITY|||||||0.0003|||||||Chi-squared|||This analysis pertains to Week 3||||0.0003
91675526|NCT03247517|183245387|SUPERIORITY|||||||0.0001|||||||Chi-squared|||This analysis pertains to Week 4||||0.0001
91675527|NCT03247517|183245387|SUPERIORITY|||||||0.0025|||||||Chi-squared|||This analysis pertains to Week 5||||0.0025
91675528|NCT03247517|183245387|SUPERIORITY|||||||0.0033|||||||Chi-squared|||This analysis pertains to Week 6||||0.0033
91675529|NCT03573505|183245393|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.112|TWO_SIDED|95.0|0.85|4.73|||Log Rank|||A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.||4.73|0.85|0.112
91526639|NCT00437125|182928616|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.||||<0.0001
91526640|NCT00437125|182928616|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.||||<0.0001
91675530|NCT00515541|183245413|SUPERIORITY_OR_OTHER|||||||0.01||||||A P-value \<0.05 when compared to baseline is considered significant.|Wilcoxon (Mann-Whitney)|||Group B baseline vs. Group B Week 12||||0.01
91675531|NCT00515541|183245414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 6.||||<0.001
91675532|NCT00515541|183245414|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 12.||||<0.001
91675533|NCT01421342|183245424|SUPERIORITY||Odds Ratio (OR)|1.31||||0.076|TWO_SIDED|95.0|0.97|1.75||Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||1.75|0.97|0.076
91675534|NCT01421342|183245424|SUPERIORITY||Odds Ratio (OR)|1.42||||0.018|TWO_SIDED|95.0|1.06|1.89||Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||1.89|1.06|0.018
91675535|NCT01421342|183245424|SUPERIORITY||Odds Ratio (OR)|1.11||||0.46|TWO_SIDED|95.0|0.84|1.48||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.|Regression, Logistic||Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.||1.48|0.84|0.46
91675536|NCT01421342|183245425|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.7|TWO_SIDED|95.0|0.78|2.39|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||2.39|0.78|0.70
91675537|NCT01421342|183245425|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.68|TWO_SIDED|95.0|0.65|1.94|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|||1.94|0.65|0.68
91675538|NCT01421342|183245425|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.87|TWO_SIDED|95.0|0.58|1.59|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.59|0.58|0.87
91526641|NCT00437125|182928617|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.||||<0.0001
91675539|NCT01421342|183245426|SUPERIORITY||Odds Ratio (OR)|1.16||||0.28|TWO_SIDED|95.0|0.89|1.5|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.||1.50|0.89|0.28
91675540|NCT01421342|183245426|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.0001|TWO_SIDED|95.0|1.33|2.29|||Regression, Logistic|Stratified by participating medical center (site)|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.33|<0.0001
91527503|NCT04534114|182930303|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.45||||0.612|TWO_SIDED|95.0|0.34|6.08|||Log Rank|||||6.08|0.34|0.612
91486143|NCT01675427|182845282|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0020
91675541|NCT01421342|183245426|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.17|2.05||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||2.05|1.17|0.002
91675542|NCT01421342|183245427|SUPERIORITY||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.68||After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|||1.68|0.95|0.11
91675543|NCT01421342|183245427|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.26|2.29|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.26|<0.001
91675544|NCT01421342|183245427|SUPERIORITY||Odds Ratio (OR)|1.37||||0.043|TWO_SIDED|95.0|1.01|1.86||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic||Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.86|1.01|0.043
91675545|NCT03261960|183245465|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91675546|NCT01300052|183245480|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|95.0|-14.3|21.8||||||Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.||21.8|-14.3|
91675547|NCT00706381|183245507|SUPERIORITY||Percent change from placebo|7.87|STANDARD_DEVIATION|9.2||0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.0001
91675548|NCT00706381|183245507|SUPERIORITY||Percent change from placebo|9.25|STANDARD_DEVIATION|8.3|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
91675549|NCT00706381|183245507|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|6.2||0.89|TWO_SIDED||||||Percent change from placebo|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.89
91675550|NCT00706381|183245507|SUPERIORITY||Percent change from placebo|-0.3|STANDARD_DEVIATION|7.2||0.41|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.41
91675551|NCT00706381|183245508|SUPERIORITY||Percent change from placebo|40.0|STANDARD_DEVIATION|72.8||0.096|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.096
91675552|NCT00706381|183245508|SUPERIORITY||Percent change from placebo|260.4|STANDARD_DEVIATION|191.7|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
91675553|NCT00706381|183245508|SUPERIORITY||Percent change from placebo|16.4|STANDARD_DEVIATION|56.3||0.83|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.83
91675554|NCT00706381|183245508|SUPERIORITY||Percent change from placebo|125.7|STANDARD_DEVIATION|92.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
91675555|NCT00767520|183245531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.148|||||||Un-stratified log-rank test|||||||0.148
91675556|NCT02480582|183245547|SUPERIORITY_OR_OTHER||||||<|0.01||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||||||<0.01
91675557|NCT02480582|183245548|SUPERIORITY_OR_OTHER||||||<|0.05||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in wanting for high fat foods between almonds, cheese savouries and no food.||||||<0.05
91675558|NCT02480582|183245549|SUPERIORITY_OR_OTHER||||||<|0.001||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in hunger AUC between almonds, cheese savouries and no food.||||||<0.001
91486144|NCT01675427|182845283|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
91486145|NCT01675427|182845283|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0061
91486146|NCT01675427|182845283|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
91526642|NCT02248961|182928624|OTHER|It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.0|=|0.39|ONE_SIDED|95.0||1.47|||Mixed Models Analysis|||"The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).~Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases."||1.47||=0.390
91642092|NCT01054443|183175792|OTHER||Cochran-Armitage Trend Test Statistic|0.173||||0.431|||||||Cochran-Armitage Trend Test|||The primary efficacy evaluation was to test if there was a linear relationship existing such that the higher the dose level, the larger the percentage of responders. The Cochran-Armitage trend test was employed by assigning the score 0, 0.5, 0.75, and 1 to placebo, lusutrombopag 0.5, 0.75, and 1.0 mg group, respectively, at the 0.025 level of significance (1-sided) to determine the test statistic for detecting a dose-response in the percentage of responders.||||0.431
91642093|NCT01054443|183175793|OTHER||LS Mean Difference|25544.0|||||TWO_SIDED|95.0|6202.8|44885.3|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||44885.3|6202.8|
91642094|NCT01054443|183175793|OTHER||LS Mean Difference|11801.3|||||TWO_SIDED|95.0|-8809.3|32411.9|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||32411.9|-8809.3|
91642095|NCT01054443|183175793|OTHER||LS Mean Difference|756.6|||||TWO_SIDED|95.0|-18794.3|20307.5|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||20307.5|-18794.3|
91642096|NCT00296192|183175823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.91||||95.0|-2.9|8.7|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.7|-2.9|
91642097|NCT00296192|183175823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|2.93||||95.0|-5.7|6.0|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||6.0|-5.7|
91486147|NCT01675427|182845283|SUPERIORITY_OR_OTHER|||||||0.3885|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3885
91486148|NCT01675427|182845283|SUPERIORITY_OR_OTHER|||||||0.3597|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3597
91526643|NCT02248961|182928625|OTHER||||||=|0.018|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.018
91642098|NCT00296192|183175823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.86||||95.0|-2.8|8.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.6|-2.8|
91642099|NCT00296192|183175823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.02||||95.0|-7.4|4.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||4.6|-7.4|
91642100|NCT00296192|183175824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|STANDARD_ERROR_OF_MEAN|8.58||||95.0|-25.7|8.5|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||8.5|-25.7|
91642101|NCT00296192|183175824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|8.63||||95.0|-34.0|0.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||0.4|-34.0|
91642102|NCT00296192|183175824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|8.45||||95.0|-18.2|15.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||15.4|-18.2|
91642103|NCT00296192|183175824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|STANDARD_ERROR_OF_MEAN|8.9||||95.0|-23.3|12.2|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||12.2|-23.3|
91642104|NCT00296192|183175825|SUPERIORITY_OR_OTHER||Difference in proportions|-20.6||||||95.0|-53.3|12.1|||Confidence interval|||95% confidence interval in difference in success rate||12.1|-53.3|
91642105|NCT00296192|183175825|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
91642106|NCT00296192|183175825|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||||95.0|-30.6|30.6|||95% confidence interval|||95% confidence interval in difference in success rate||30.6|-30.6|
91642107|NCT00296192|183175825|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
91642108|NCT03504839|183175828|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91642109|NCT03491800|183175862|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_ERROR_OF_MEAN|0.15||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
91642110|NCT03491800|183175863|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
91642111|NCT03491800|183175863|SUPERIORITY||Mean Difference (Final Values)|4.44|STANDARD_ERROR_OF_MEAN|0.26||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
91642112|NCT03491800|183175864|SUPERIORITY||Mean Difference (Final Values)|-3.03|STANDARD_ERROR_OF_MEAN|-0.28||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
91642113|NCT03491800|183175864|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.22||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
91642114|NCT03491800|183175865|SUPERIORITY||Mean Difference (Final Values)|-5.05|STANDARD_ERROR_OF_MEAN|-0.25||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
91642115|NCT03491800|183175866|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
91642116|NCT03491800|183175867|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_ERROR_OF_MEAN|-0.2||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
91642117|NCT03491800|183175868|SUPERIORITY||Mean Difference (Final Values)|-38.25|STANDARD_ERROR_OF_MEAN|-38.25||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
91642118|NCT03491800|183175868|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|22.0||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
91642119|NCT03491800|183175868|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|9.62||0.054|TWO_SIDED||||||t-test, 2 sided|||||||0.054
91642120|NCT03491800|183175869|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.4||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
91642121|NCT03491800|183175869|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|3.29||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
91642122|NCT05604521|183175870|SUPERIORITY|||||||0.3944|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any local solicited AEs after any vaccination.||||0.3944
91642123|NCT05604521|183175870|SUPERIORITY|||||||0.3717|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any systemic solicited AEs after any vaccination.||||0.3717
91642124|NCT05604521|183175870|SUPERIORITY|||||||1|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any related unsolicited AEs after any vaccination.||||1.0
91642125|NCT03681769|183175879|EQUIVALENCE|Non-equivalence determined by p\<.05.||||||0.83||||||No site X time interaction (F12,270 = 0.614, p = 0.830).|Mixed Models Analysis|||||||.83
91642126|NCT03681769|183175880|OTHER|||||||0.53|||||||t-test, 2 sided|||||||.53
91642127|NCT00750373|183175944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.||||<0.05
91642128|NCT05027958|183175949|SUPERIORITY|||||||0.05714|||||||Wilcoxon (Mann-Whitney)|||||||0.05714
91642129|NCT03155269|183175951|OTHER||Mean Difference (Final Values)|-0.0423||||0.1324|TWO_SIDED|97.5|-0.1057|0.0211||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.0211|-0.1057|0.1324
91642130|NCT03155269|183175952|OTHER||Mean Difference (Final Values)|0.229||||0.0469|TWO_SIDED|97.5|-0.03|0.489||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.489|-0.030|0.0469
91642131|NCT02871921|183175970|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.86||0.87|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among participants with normal cognition||||0.87
91675559|NCT02480582|183245550|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||"Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food."||||<0.05
91642132|NCT02871921|183175970|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.76||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among MCI||||.03
91642133|NCT02871921|183175971|EQUIVALENCE|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|2.56|STANDARD_ERROR_OF_MEAN|1.19||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: Category fluency animals Among participants with normal cognition||||0.03
91642134|NCT02871921|183175971|OTHER|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.93||0.46|TWO_SIDED||||||Regression, Linear|||Outcome: Category Fluency (Animals) at Month 6 Among MCI participants||||0.46
91642135|NCT02871921|183175972|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Stroy Immediate Recall score at Month 6, controlling for its baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.82||0.45|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Stroy Immediate Recall (paraphrase scoring) Among participants with normal cognition||||0.45
91642136|NCT02871921|183175972|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.8||0.41|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Immediate Recall (paraphrase) Among MCI||||0.41
91692190|NCT03296527|183279356|SUPERIORITY||Mean ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.74|0.88||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of LH on stimulation Day 6||0.88|0.74|<0.001
91692191|NCT03296527|183279357|SUPERIORITY||Mean ratio|0.9||||0.018|TWO_SIDED|95.0|0.82|0.98||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of LH at end-of-stimulation||0.98|0.82|0.018
91692192|NCT03296527|183279358|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.84||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol on stimulation Day 6||0.84|0.70|<0.001
91692193|NCT03296527|183279359|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.81||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol at end-of-stimulation||0.81|0.68|<0.001
91692194|NCT03296527|183279360|SUPERIORITY||Mean Ratio|0.89||||0.003|TWO_SIDED|95.0|0.82|0.96||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone on stimulation Day 6||0.96|0.82|0.003
91692195|NCT03296527|183279361|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.79||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone at end-of-stimulation||0.79|0.68|<0.001
91692196|NCT03296527|183279362|SUPERIORITY||Mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of Inhibin A on stimulation Day 6||0.83|0.70|<0.001
91692197|NCT03296527|183279363|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin A at end-of-stimulation||0.83|0.71|<0.001
91692198|NCT03296527|183279364|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.89||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B on stimulation Day 6||0.89|0.77|<0.001
91692199|NCT03296527|183279365|SUPERIORITY||Mean ratio|0.87||||0.001|TWO_SIDED|95.0|0.8|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B at end-of-stimulation||0.95|0.80|0.001
91692200|NCT03296527|183279366|SUPERIORITY||Mean ratio|1.08|||<|0.001|TWO_SIDED|95.0|1.04|1.12||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH on stimulation Day 6||1.12|1.04|<0.001
91642137|NCT02871921|183175973|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.77||0.74|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall) (Paraphrase scoring) Among participants with normal cognition||||0.74
91642138|NCT02871921|183175973|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall (Paraphrase scoring) Among MCI||||0.90
91642139|NCT03056456|183175977|SUPERIORITY||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.81|1.23||||||Day 1||1.23|0.810|
91642140|NCT03056456|183175977|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.817|1.25||||||Day 3||1.25|0.817|
91642141|NCT03056456|183175978|SUPERIORITY||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.808|1.31||||||Day 1||1.31|0.808|
91642142|NCT03056456|183175978|SUPERIORITY|Day 3|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.82|1.32||||||||1.32|0.820|
91642143|NCT02234427|183176003|SUPERIORITY_OR_OTHER||||||<|5e-06||||||Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.|negative binomial|||Null Hypothesis: There is no difference in gene expression before and after aspirin therapy||||<0.000005
91642144|NCT01244516|183176010|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|97.4|-5.91|6.7|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - AOA.|This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B \<= -5. Ha: galyfilcon A - lotrafilcon B \> -5.||6.70|-5.91|
91642145|NCT01244516|183176010|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|97.4|-5.96|6.79|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - BIO.|This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A \<= -5. Ha: galyfilcon A- comfilcon A\> -5.||6.79|-5.96|
91642146|NCT01244516|183176011|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP/AOA.|The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR \> 1 for (AAHP/AOA).||2.44|1.14|
91642147|NCT01244516|183176011|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.||The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR \> 1 for (AAHP/BIO).||2.44|1.14|
91642148|NCT04668066|183176067|OTHER||Least Square Mean Difference|5.6||||0.6343|TWO_SIDED|90.0|-21.4|32.6|||ANCOVA|||||32.6|-21.4|0.6343
91642149|NCT03810417|183176087|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
91642150|NCT03810417|183176087|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
91642151|NCT00056472|183176107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.001||95.0|1.12|1.47|||Regression, Logistic|||Predicting remission rates of 40% in combination therapy and 20% in monotherapy subjects, 260 subjects randomized into the two treatment groups would provide \>80% power at a two-tailed alpha level of .05. Treatment efficacy was compared between groups based on intent-to-treat analyses for the longitudinal binary outcome of remission using mixed effects logistic regression with a random intercept that included treatment and time as fixed effects and a treatment by time interaction effect.||1.47|1.12|<.001
91642152|NCT00056472|183176108|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The p-value is for the overall mean CGI-S score compared to baseline.|Mixed Models Analysis|This was a longitudinal analysis of CGI-S scores compared to baseline.||Intent-to-treat changes in global improvement from week to week compared to baseline (CGI-S) over the course of the trial using longitudinal mixed effects linear regression models. The null hypothesis is that there is no difference in overall change in CGI-S.||||.02
91642153|NCT00056472|183176109|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the overall mean across all time points between each treatment group.|Mixed Models Analysis|||Intent-to-treat between group comparison using longitudinal mixed effects regression.||||<.001
91642154|NCT00299546|183176185|SUPERIORITY_OR_OTHER||||||<|0.001||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX)||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a \>90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40\~55% ACR 20 response in golimumab groups.||||<0.001
91642155|NCT00299546|183176185|SUPERIORITY_OR_OTHER|||||||0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg.||||0.001
91642156|NCT00299546|183176185|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg.||||<0.001
91642157|NCT00299546|183176186|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||0.003
91675560|NCT01901874|183245576|OTHER|"Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence.~Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4%~PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%"|Weighted binomial proportion|0.0448|STANDARD_ERROR_OF_MEAN|0.0241|<|1e-05|ONE_SIDED|95.1||0.0846||A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.|Binomial test (normal approximation)||Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.|"Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P \< 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1."||0.0846||<0.00001
91675561|NCT01901874|183245584|OTHER||Cumulative probability|0.018|||||TWO_SIDED|95.0|0.007|0.047|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.047|0.007|
91675562|NCT01901874|183245585|OTHER||Cumulative probability|0.022|||||TWO_SIDED|95.0|0.009|0.052|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.052|0.009|
91675563|NCT03020719|183245676|SUPERIORITY||Mean Difference (Final Values)|-0.081||||0.2521|TWO_SIDED|95.0|-0.221|0.059|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\< 6 years, ≥ 6 years), and baseline weight-for-age z-score category (\< -0.52, ≥ -0.52).|Model incorporates Week 12 weight-for-age z-score, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.059|-0.221|0.2521
91675564|NCT03020719|183245677|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.089|TWO_SIDED|95.0|-0.18|0.01|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.01|-0.18|0.0890
91675565|NCT03020719|183245678|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.573|TWO_SIDED|95.0|-0.28|0.15|||Mixed Models Analysis|Model adjusted from randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.15|-0.28|0.5730
91675566|NCT03020719|183245679|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.4259|TWO_SIDED|95.0|-0.17|0.4|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.40|-0.17|0.4259
91675567|NCT03020719|183245680|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.4666|TWO_SIDED|95.0|-2.06|0.96|||ANCOVA|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).||||0.96|-2.06|0.4666
91675568|NCT03020719|183245681|SUPERIORITY||Difference in % of Participants with AE|0.0||||1|TWO_SIDED|95.0|-13.6|13.6|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||13.6|-13.6|1.0000
91675569|NCT03020719|183245681|SUPERIORITY||Difference in % of Participants with SAE|-13.3||||0.1945|TWO_SIDED|95.0|-30.5|2.9|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||2.9|-30.5|0.1945
91675570|NCT03020719|183245682|SUPERIORITY||Rate Ratio|1.21||||0.1087|TWO_SIDED|95.0|0.96|1.52|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||1.52|0.96|0.1087
91642158|NCT00299546|183176186|SUPERIORITY_OR_OTHER|||||||0.021||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.021
91675571|NCT03020719|183245682|SUPERIORITY||Rate Ratio|0.12||||0.0122|TWO_SIDED|95.0|0.01|0.67|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||0.67|0.01|0.0122
91675572|NCT02340221|183245686|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0037|TWO_SIDED|95.0|0.56|0.89|||Log Rank|||||0.89|0.56|0.0037
91675573|NCT02340221|183245687|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0008|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.0008
91675574|NCT02340221|183245688|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0002|TWO_SIDED|95.0|1.6|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.6|0.0002
91675575|NCT02340221|183245689|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.7|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.7|<0.0001
91675576|NCT02340221|183245690|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4151|TWO_SIDED|95.0|0.58|1.25|||Log Rank|||||1.25|0.58|0.4151
91675577|NCT02340221|183245691|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9974|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||||1.33|0.75|0.9974
91675578|NCT02340221|183245692|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|2.9||||||||2.9|1.2|
91675579|NCT02340221|183245693|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|3.0||||||||3.0|1.2|
91675580|NCT02340221|183245694|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.6708|TWO_SIDED|95.0|0.23|2.59|||Log Rank|||||2.59|0.23|0.6708
91675581|NCT02340221|183245695|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8286|TWO_SIDED|95.0|0.51|2.35|||Log Rank|||||2.35|0.51|0.8286
91642159|NCT00299546|183176186|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
91642160|NCT00299546|183176187|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methorexate (MTX).||||||<0.001
91642161|NCT00299546|183176187|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
91642162|NCT00299546|183176187|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
91642163|NCT00299546|183176188|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||<0.001
91642164|NCT00299546|183176188|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
91642165|NCT00299546|183176188|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
91642166|NCT00299546|183176189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|Stratified by baseline Methotrexate (MTX).||||||<0.001
91642167|NCT00299546|183176189|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
91642168|NCT00299546|183176189|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
91642169|NCT01656850|183176199|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91642170|NCT01656850|183176200|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||Mixed Models Analysis|||||||0.2786
91642171|NCT01656850|183176201|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.420
91642172|NCT01656850|183176202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91642173|NCT01656850|183176203|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED||||||Mixed Models Analysis|||||||0.2412
91675582|NCT02340221|183245696|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0023|TWO_SIDED|95.0|0.51|0.86|||Log Rank|||||0.86|0.51|0.0023
91486149|NCT01675427|182845283|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91486150|NCT01675427|182845284|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91642174|NCT01656850|183176204|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Mixed Models Analysis|||||||0.3837
91642175|NCT01656850|183176205|SUPERIORITY_OR_OTHER|||||||0.9784|TWO_SIDED||||||Mixed Models Analysis|||||||0.9784
91642176|NCT01656850|183176206|SUPERIORITY_OR_OTHER|||||||0.5868|TWO_SIDED||||||Mixed Models Analysis|||||||0.5868
91642177|NCT01656850|183176207|SUPERIORITY_OR_OTHER|||||||0.1101|TWO_SIDED||||||Mixed Models Analysis|||||||0.1101
91642178|NCT01656850|183176208|SUPERIORITY_OR_OTHER|||||||0.7823|TWO_SIDED||||||Mixed Models Analysis|||||||0.7823
91642179|NCT01656850|183176209|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Mixed Models Analysis|||||||0.5570
91642180|NCT01656850|183176210|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Mixed Models Analysis|||||||0.6263
91642181|NCT01656850|183176211|SUPERIORITY_OR_OTHER|||||||0.8328|TWO_SIDED||||||Mixed Models Analysis|||||||0.8328
91642182|NCT01656850|183176212|SUPERIORITY_OR_OTHER|||||||0.7758|TWO_SIDED||||||Mixed Models Analysis|||||||0.7758
91642183|NCT01656850|183176213|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Mixed Models Analysis|||||||0.0476
91642184|NCT01656850|183176214|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||Mixed Models Analysis|||||||0.1205
91642185|NCT01656850|183176215|SUPERIORITY_OR_OTHER|||||||0.1512|TWO_SIDED||||||Mixed Models Analysis|||||||0.1512
91642186|NCT01656850|183176216|SUPERIORITY_OR_OTHER|||||||0.7364|TWO_SIDED||||||Mixed Models Analysis|||||||0.7364
91642187|NCT01656850|183176217|SUPERIORITY_OR_OTHER|||||||0.1995|TWO_SIDED||||||Mixed Models Analysis|||||||0.1995
91642188|NCT01656850|183176218|SUPERIORITY_OR_OTHER|||||||0.8528|TWO_SIDED||||||Mixed Models Analysis|||||||0.8528
91642189|NCT00337727|183176251|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
91642190|NCT00337727|183176252|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
91642191|NCT04456998|183176279|SUPERIORITY||Mean Difference (Net)|-96.1||||0.031|TWO_SIDED|95.0|-183.5|-8.8|||ANCOVA||GB002 vs. Placebo|||-8.8|-183.5|0.0310
91642192|NCT04456998|183176280|SUPERIORITY||Mean Difference (Net)|6.5||||0.5972|TWO_SIDED|95.0|-17.9|30.9|||Mixed Models Analysis||GB002 vs. Placebo|||30.9|-17.9|0.5972
91642193|NCT02080273|183176281|OTHER|||||||0.919|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.919
91642194|NCT02080273|183176282|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
91642195|NCT02080273|183176283|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
91642196|NCT02080273|183176284|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
91642197|NCT02080273|183176285|OTHER|||||||0.922|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.922
91526644|NCT02248961|182928626|OTHER||||||=|0.579|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.579
91675583|NCT02340221|183245697|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0095|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.0095
91675584|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.01||||||95.0|-2.87|-1.14|||||Mean (Day 8 - baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.14|-2.87|
91675585|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||||95.0|-3.49|-1.8|||||Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.80|-3.49|
91675586|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||||95.0|-3.9|-1.9|||||Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.90|-3.90|
91675587|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.38||||||95.0|-4.59|-2.17|||||Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.17|-4.59|
91675588|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73||||||95.0|-5.15|-4.31|||||Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-4.31|-5.15|
91675589|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.93||||||95.0|-2.68|-1.18|||||Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.18|-2.68|
91675590|NCT00518622|183245705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||||95.0|-2.78|-2.13|||||Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.13|-2.78|
91675591|NCT02655016|183245725|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.502|0.755||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.755|0.502|<0.0001
91675592|NCT02655016|183245726|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1238|TWO_SIDED|95.0|0.442|1.106||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.106|0.442|0.1238
91675593|NCT02655016|183245727|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0001|TWO_SIDED|95.0|0.521|0.802||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.802|0.521|0.0001
91675594|NCT02655016|183245728|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.2242|TWO_SIDED|95.0|0.577|1.139||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.139|0.577|0.2242
91675595|NCT02588950|183245788|SUPERIORITY||Geometric LSMean Ratio|1.46|||||TWO_SIDED|90.0|1.08|1.97|||Mixed Models Analysis|||||1.97|1.08|
91675596|NCT02588950|183245792|SUPERIORITY||Geometric LSMean Ratio|0.885|||||TWO_SIDED|90.0|0.761|1.03|||Mixed Models Analysis|||||1.03|0.761|
91675597|NCT02588950|183245793|SUPERIORITY||Median Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-1.6|2.6||||||||2.60|-1.60|
91675598|NCT01936519|183245799|EQUIVALENCE|Mann Whitney U Test was performed|Mean Difference (Net)|27.32|STANDARD_ERROR_OF_MEAN|20.61||0.283|TWO_SIDED|95.0|-16.17|70.8||Cockcroft-Gault Clearance|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Cockcroft Gault Creatinine clearance 2 year data.||70.80|-16.17|0.283
91675599|NCT01936519|183245800|EQUIVALENCE|Wilcoxon Test|Median Difference (Final Values)|34.08|STANDARD_ERROR_OF_MEAN|11.44||0.013|TWO_SIDED|95.0|9.95|58.21|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the MDRD Clearance 2 year data row data.||58.21|9.95|0.013
91675600|NCT01936519|183245801|EQUIVALENCE|Wilcoxon Test|Mean Difference (Final Values)|22.22|STANDARD_ERROR_OF_MEAN|12.09||0.099|TWO_SIDED|95.0|-3.28|47.72|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Iothalamate Clearance 2 year data.||47.72|-3.28|0.099
91675601|NCT01936519|183245801|EQUIVALENCE|Non-parametric statistical tests were used for all analyses, including the Mann-Whitney U test for continuous outcomes and Pearson's chi-square test for binary outcomes. Univariate statistical tests were used for all comparisons. Cohen's d was utilized for all comparisons to provide information about effect size.|Mean Difference (Final Values)|29.08|STANDARD_ERROR_OF_MEAN|13.29||0.032|TWO_SIDED|95.0|1.04|57.1|||Wilcoxon (Mann-Whitney)|||"Power and sample size. The assumption was made that eGFR would improve from 34 mL/min/1.73 m2 to 43 mL/min/1.73 m2. It was determined that a sample size of 12 in each group would have 80% power to detect a difference in means of -9.0 (the difference between a group 1 mean of 34.0 and a group 2 mean of 43.0) assuming that the common standard deviation was 7.5 using a two group t-test with a 0.05 two-sided significance level.~Data from the 2 year time point was used for analysis."||57.1|1.04|.032
91526645|NCT02248961|182928627|OTHER||||||=|0.466|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.466
91526646|NCT02248961|182928628|OTHER||||||=|0.118|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.118
91675602|NCT01936519|183245801|EQUIVALENCE|Difference of zero hypothesized.|Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.263||0.015|TWO_SIDED|95.0|-1.11|-0.003|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on 2 year data time point.||-0.003|-1.11|0.015
91642198|NCT02080273|183176286|OTHER|||||||0.848||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline||||0.848
91642199|NCT02080273|183176287|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
91675603|NCT02072824|183245812|SUPERIORITY||Least Square Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4606|TWO_SIDED|95.0|-0.19|0.42|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||0.42|-0.19|0.4606
91486151|NCT01675427|182845284|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0005
91486152|NCT01675427|182845284|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0110
91642200|NCT02080273|183176288|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
91642201|NCT03707145|183176290|SUPERIORITY||Partial Eta Squared|0.058|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
91642202|NCT03707145|183176291|SUPERIORITY||Partial Eta Squared|0.008|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
91642203|NCT04221477|183176297|SUPERIORITY||Adjusted Difference|13.4||||0.0232|TWO_SIDED|95.0|1.95|24.84||Test 1 of 7 maintaining a fixed sequence testing for type I error control at two-sided alpha 0.05.|Cochran-Mantel-Haenszel|||||24.84|1.95|0.0232
91642204|NCT04221477|183176298|SUPERIORITY||Adjusted Difference|11.88||||0.0421|TWO_SIDED|95.0|0.57|23.18||Test 2 of 7 maintaining a fixed sequence testing for type I error control at two-sided alpha 0.05.|Cochran-Mantel-Haenszel|||||23.18|0.57|0.0421
91642205|NCT04221477|183176299|SUPERIORITY||Adjusted Difference|13.68||||0.0227|TWO_SIDED|95.0|2.01|25.36||Test 3 of 7 maintaining a fixed sequence testing for type I error control at two-sided alpha 0.04 with fallback method.|Cochran-Mantel-Haenszel|||||25.36|2.01|0.0227
91642206|NCT04221477|183176300|SUPERIORITY||Difference in Adjusted Means|3.84||||0.1842|TWO_SIDED|95.0|-1.83|9.51||Test 4 of 7 maintaining a fixed sequence testing for type I error control at two-sided alpha 0.05.|ANCOVA|||||9.51|-1.83|0.1842
91675604|NCT02072824|183245812|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.185||0.0223|TWO_SIDED|95.0|-0.8|-0.06|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||-0.06|-0.80|0.0223
91486153|NCT01675427|182845284|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0980
91486154|NCT01675427|182845284|SUPERIORITY_OR_OTHER|||||||0.2264|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2264
91486155|NCT01675427|182845284|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91642207|NCT04221477|183176301|SUPERIORITY||Adjusted Difference|-16.83||||0.0026|TWO_SIDED|95.0|-27.42|-6.23||Ranked 5 of 7 in the fixed sequence for type I error control. P-value is nominal as the hierarchical testing stops at the first non-significant endpoint.|Cochran-Mantel-Haenszel|||||-6.23|-27.42|0.0026
91642208|NCT04221477|183176302|SUPERIORITY||Adjusted Difference|8.36||||0.167|TWO_SIDED|95.0|-3.41|20.12||Ranked 6 of 7 in the fixed sequence for type I error control.|Cochran-Mantel-Haenszel|||||20.12|-3.41|0.1670
91642209|NCT04221477|183176303|SUPERIORITY||Difference in Adjusted Means|-1.35||||0.2991|TWO_SIDED|95.0|-3.89|1.2||Ranked 7 of 7 in the fixed sequence for type I error control.|ANCOVA|||||1.20|-3.89|0.2991
91642210|NCT04221477|183176304|SUPERIORITY||Difference in Adjusted Means|-0.36||||0.0006|TWO_SIDED|95.0|-0.57|-0.16||Not type I error controlled.|ANCOVA|||||-0.16|-0.57|0.0006
91642211|NCT04221477|183176305|SUPERIORITY||Difference in Adjusted Means|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||Not type I error controlled|ANCOVA|||||0.20|0.08|<0.0001
91642212|NCT04221477|183176306|SUPERIORITY||Difference in Adjusted Means|-0.12||||0.9384|TWO_SIDED|95.0|-3.11|2.87||Not type I error controlled.|ANCOVA|||||2.87|-3.11|0.9384
91642213|NCT04221477|183176307|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.1324|TWO_SIDED|95.0|0.91|1.89||Not type I error controlled.|Log Rank|||||1.89|0.91|0.1324
91642214|NCT04221477|183176308|SUPERIORITY||Adjusted Difference|13.37||||0.0237|TWO_SIDED|95.0|1.91|24.82||Not type I error controlled.|Cochran-Mantel-Haenszel|||||24.82|1.91|0.0237
91642215|NCT00965562|183176340|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
91642216|NCT00965562|183176341|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
91642217|NCT00965562|183176342|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91642218|NCT00965562|183176343|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared|||||||0.09
91675605|NCT02072824|183245813|SUPERIORITY||Odds Ratio (OR)|0.625||||0.2418|TWO_SIDED|95.0|0.284|1.373|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||1.373|0.284|0.2418
91526647|NCT02248961|182928629|OTHER||||||=|0.662|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.662
91526648|NCT02248961|182928630|OTHER||||||=|0.143|||||||Mantel Haenszel|||||||=0.143
91526649|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.05|TWO_SIDED|95.0|0.8|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for used (injected/snorted/smoked) heroin in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|0.80|0.05
91526650|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.01|TWO_SIDED|95.0|1.12|2.76|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for having Used (injected/snorted/smoked) powder cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.76|1.12|0.01
91526651|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|1.0|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected and/or snorted) crack cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|1.00|0.05
91526652|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.03|TWO_SIDED|95.0|0.35|0.98|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected/snorted/smoked) methamphetamine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.98|0.35|0.03
91526653|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||<|0.01|TWO_SIDED|95.0|1.11|3.59|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for poly-substance use in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.59|1.11|<0.01
91526654|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.01|TWO_SIDED|95.0|3.84|12.28|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for Heavy drinking (\>14 and \>21 drinks/week for women and men respectively) in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||12.28|3.84|<0.01
91642219|NCT00965562|183176344|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
91642220|NCT00965562|183176345|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
91642221|NCT00965562|183176346|SUPERIORITY_OR_OTHER||Slope|-2.63||||0.07|TWO_SIDED|95.0|-5.51|0.24|||Mixed Models Analysis||Slope represents average change in fluoxetine group IDS score as compared to placebo|||0.24|-5.51|0.07
91642222|NCT00965562|183176346|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.94|TWO_SIDED|95.0|-2.85|2.65|||Mixed Models Analysis||Slope represents average change in calcium group IDS scores as compared to placebo|||2.65|-2.85|0.94
91642223|NCT00965562|183176346|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.15||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
91642224|NCT00965562|183176346|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.1||||0.94|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.94
91642225|NCT00965562|183176347|SUPERIORITY_OR_OTHER||Slope|-1.63||||0.1|TWO_SIDED|95.0|-3.6|0.34|||Mixed Models Analysis||Slope represents average change in fluoxetine group PMTS scores as compared to placebo|||0.34|-3.60|0.10
91642226|NCT00965562|183176347|SUPERIORITY_OR_OTHER||Slope|-0.81||||0.4|TWO_SIDED|95.0|-2.71|1.09|||Mixed Models Analysis||Slope represents average change in calcium group PMTS scores as compared to placebo|||1.09|-2.71|0.40
91642227|NCT00965562|183176347|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06||||0.1|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.10
91642228|NCT00965562|183176347|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37||||0.4|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.40
91642229|NCT00965562|183176348|SUPERIORITY_OR_OTHER||Slope|-0.35||||0.07|TWO_SIDED|95.0|-0.73|0.03|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI-S scores as compared to placebo|||0.03|-0.73|0.07
91642230|NCT00965562|183176348|SUPERIORITY_OR_OTHER||Slope|-0.17||||0.36|TWO_SIDED|95.0|-0.54|0.2|||Mixed Models Analysis||Slope represents average change in calcium group CGI-S scores as compared to placebo|||0.20|-0.54|0.36
91642231|NCT00965562|183176348|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.92||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
91642232|NCT00965562|183176348|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.44||||0.36|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.36
91642233|NCT00965562|183176349|SUPERIORITY_OR_OTHER||Slope|-0.28||||0.02|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis||Slope represents average change in fluoxetine group DRSP scores as compared to placebo|||-0.04|-0.53|0.02
91642234|NCT00965562|183176349|SUPERIORITY_OR_OTHER||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28|||Mixed Models Analysis||Slope represents average change in calcium group DRSP scores as compared to placebo|||0.28|-0.16|0.58
91486156|NCT01675427|182845285|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0098
91642235|NCT00965562|183176349|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08||||0.02|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.02
91675606|NCT02072824|183245813|SUPERIORITY||Odds Ratio (OR)|1.622||||0.305|TWO_SIDED|95.0|0.644|4.086|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||4.086|0.644|0.3050
91526655|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.01|TWO_SIDED|95.0|2.02|6.5|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Drank until blacked out in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||6.50|2.02|<0.01
91642236|NCT00965562|183176349|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.18||||0.58|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.58
91642237|NCT00965562|183176350|SUPERIORITY_OR_OTHER||Slope|-1.03||||0.04|TWO_SIDED|95.0|-1.7|-0.35|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI Improvement scores as compared to placebo|||-0.35|-1.70|0.04
91642238|NCT00965562|183176350|SUPERIORITY_OR_OTHER||Slope|-0.2||||0.54|TWO_SIDED|95.0|-0.86|0.46|||Mixed Models Analysis||Slope represents average change in calcium group CGI Improvement scores as compared to placebo|||0.46|-0.86|0.54
91642239|NCT00965562|183176350|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.8||||0.04|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.04
91642240|NCT00965562|183176350|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.32||||0.54|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.54
91642241|NCT05455684|183176356|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.2|=|0.467|TWO_SIDED|95.0|-3.24|1.49|||Mixed Model for Repeated Measures|||||1.49|-3.24|=0.467
91642242|NCT05455684|183176361|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.21|0.52||||||||0.52|-2.21|
91675607|NCT03835325|183245826|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The sample size calculation was based on the following hypothesis test:~H0: there is no improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~H1: there is an improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~or H0: AUTO-EF (VF) - AUTO-EF (VS) ≤ 0 H1: AUTO-EF (VF) - AUTO-EF (VS)\> 0"||||<0.001
91486157|NCT01675427|182845285|SUPERIORITY_OR_OTHER|||||||0.6291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.6291
91486158|NCT01675427|182845285|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
91486159|NCT01675427|182845285|SUPERIORITY_OR_OTHER|||||||0.5588|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5588
91526656|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.04|TWO_SIDED|95.0|0.33|0.93|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Injected daily, past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.93|0.33|0.04
91642243|NCT05204563|183176369|OTHER||Treatment difference|0.2|||||TWO_SIDED|95.0|-3.5|4.0||||||||4.0|-3.5|
91642244|NCT05204563|183176370|OTHER||Treatment difference|4.1|||||TWO_SIDED|95.0|-0.4|8.7||||||||8.7|-0.4|
91642245|NCT05204563|183176371|OTHER||Treatment difference|3.2|||||TWO_SIDED|95.0|-3.0|9.4||||||Day 14||9.4|-3.0|
91642246|NCT05204563|183176371|OTHER||Treatment difference|4.0|||||TWO_SIDED|95.0|-3.4|11.3||||||Day 28||11.3|-3.4|
91642247|NCT05204563|183176372|OTHER||Treatment difference|0.5|||||TWO_SIDED|95.0|-5.4|6.3||||||Day 14||6.3|-5.4|
91642248|NCT05204563|183176372|OTHER||Treatment difference|2.9|||||TWO_SIDED|95.0|-3.9|9.8||||||Day 28||9.8|-3.9|
91642249|NCT05204563|183176373|OTHER||Treatment difference|-0.8|||||TWO_SIDED|95.0|-4.9|3.3||||||Day 14||3.3|-4.9|
91642250|NCT05204563|183176373|OTHER||Treatment difference|2.2|||||TWO_SIDED|95.0|-2.7|7.2||||||Day 28||7.2|-2.7|
91642251|NCT05204563|183176374|OTHER||Treatment difference|2.1|||||TWO_SIDED|95.0|-4.7|8.9||||||Day 14||8.9|-4.7|
91642252|NCT05204563|183176374|OTHER||Treatment difference|1.3|||||TWO_SIDED|95.0|-6.5|9.1||||||Day 28||9.1|-6.5|
91642253|NCT05204563|183176375|OTHER||Treatment difference|-7.8|||||TWO_SIDED|95.0|-25.3|9.7||||||Day 14||9.7|-25.3|
91642254|NCT05204563|183176375|OTHER||Treatment difference|-7.8|||||TWO_SIDED|95.0|-25.3|9.7||||||Day 28||9.7|-25.3|
91642255|NCT05204563|183176376|OTHER||Treatment difference|3.6|||||TWO_SIDED|95.0|-6.0|13.2||||||Day 4||13.2|-6.0|
91642256|NCT05204563|183176376|OTHER||Treatment difference|3.5|||||TWO_SIDED|95.0|-5.3|12.3||||||EOT (up to Day 14)||12.3|-5.3|
91642257|NCT05204563|183176376|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-9.4|9.3||||||TOC (Day 21)||9.3|-9.4|
91642258|NCT05204563|183176376|OTHER||Treatment difference|2.7|||||TWO_SIDED|95.0|-6.9|12.2||||||LFU (Day 28)||12.2|-6.9|
91675608|NCT03395639|183245846|OTHER|Difference in adjudicated major or CRNM bleeding rates were assessed.|Annualized rate difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12||||||||0.12|-0.18|
91642259|NCT05204563|183176377|OTHER||Treatment difference|-2.2|||||TWO_SIDED|95.0|-18.1|13.6||||||Day 4||13.6|-18.1|
91642260|NCT05204563|183176377|OTHER||Treatment difference|12.3|||||TWO_SIDED|95.0|-1.6|26.3||||||EOT (up to Day 14)||26.3|-1.6|
91642261|NCT05204563|183176377|OTHER||Treatment difference|5.0|||||TWO_SIDED|95.0|-10.5|20.4||||||TOC (Day 21)||20.4|-10.5|
91642262|NCT05204563|183176377|OTHER||Treatment difference|8.9|||||TWO_SIDED|95.0|-6.9|24.7||||||LFU (Day 28)||24.7|-6.9|
91642263|NCT05204563|183176378|OTHER||Treatment difference|0.8|||||TWO_SIDED|95.0|-12.7|14.4||||||Day 4||14.4|-12.7|
91642264|NCT05204563|183176378|OTHER||Treatment difference|8.3|||||TWO_SIDED|95.0|-3.7|20.3||||||EOT (up to Day 14)||20.3|-3.7|
91642265|NCT05204563|183176378|OTHER||Treatment difference|8.6|||||TWO_SIDED|95.0|-4.8|21.9||||||TOC (Day 21)||21.9|-4.8|
91642266|NCT05204563|183176378|OTHER||Treatment difference|10.6|||||TWO_SIDED|95.0|-3.0|24.2||||||LFU (Day 28)||24.2|-3.0|
91642267|NCT05204563|183176379|OTHER||Treatment difference|2.3|||||TWO_SIDED|95.0|-8.3|12.8||||||Day 4||12.8|-8.3|
91642268|NCT05204563|183176379|OTHER||Treatment difference|1.7|||||TWO_SIDED|95.0|-6.7|10.1||||||EOT (up to Day 14)||10.1|-6.7|
91642269|NCT05204563|183176379|OTHER||Treatment Difference|0.4|||||TWO_SIDED|95.0|-9.2|10.0||||||TOC (Day 21)||10.0|-9.2|
91642270|NCT05204563|183176379|OTHER||Treatment difference|2.5|||||TWO_SIDED|95.0|-7.7|12.6||||||LFU (Day 28)||12.6|-7.7|
91642271|NCT05204563|183176380|OTHER||Treatment difference|-4.6|||||TWO_SIDED|95.0|-21.4|12.2||||||Day 4||12.2|-21.4|
91642272|NCT05204563|183176380|OTHER||Treatment difference|7.7|||||TWO_SIDED|95.0|-5.8|21.2||||||EOT (up to Day 14)||21.2|-5.8|
91642273|NCT05204563|183176380|OTHER||Treatment difference|6.3|||||TWO_SIDED|95.0|-9.4|22.0||||||TOC (Day 21)||22.0|-9.4|
91642274|NCT05204563|183176380|OTHER||Treatment difference|10.6|||||TWO_SIDED|95.0|-5.9|27.1||||||LFU (Day 28)||27.1|-5.9|
91642275|NCT05204563|183176381|OTHER||Treatment difference|5.9|||||TWO_SIDED|95.0|-20.3|32.1||||||Day 4||32.1|-20.3|
91642276|NCT05204563|183176381|OTHER||Treatment difference|18.3|||||TWO_SIDED|95.0|-5.4|42.1||||||EOT (up to Day 14)||42.1|-5.4|
91642277|NCT05204563|183176381|OTHER||Treatment difference|23.0|||||TWO_SIDED|95.0|-1.5|47.5||||||TOC (Day 21)||47.5|-1.5|
91642278|NCT05204563|183176381|OTHER||Treatment difference|14.0|||||TWO_SIDED|95.0|-11.6|39.7||||||LFU (Day 28)||39.7|-11.6|
91642279|NCT05204563|183176382|OTHER||Treatment difference|10.9|||||TWO_SIDED|95.0|-3.5|25.3||||||EOT (up to Day 14)||25.3|-3.5|
91642280|NCT05204563|183176382|OTHER||Treatment difference|6.3|||||TWO_SIDED|95.0|-9.7|22.4||||||TOC (Day 21)||22.4|-9.7|
91642281|NCT05204563|183176382|OTHER||Treatment difference|8.7|||||TWO_SIDED|95.0|-7.3|24.7||||||LFU (Day 28)||24.7|-7.3|
91642282|NCT05204563|183176383|OTHER||Treatment difference|10.6|||||TWO_SIDED|95.0|-2.3|23.5||||||EOT (up to Day 14)||23.5|-2.3|
91642283|NCT05204563|183176383|OTHER||Treatment difference|6.4|||||TWO_SIDED|95.0|-7.2|20.0||||||TOC (Day 21)||20.0|-7.2|
91642284|NCT05204563|183176383|OTHER||Treatment difference|5.3|||||TWO_SIDED|95.0|-8.2|18.9||||||LFU (Day 28)||18.9|-8.2|
91642285|NCT05204563|183176384|OTHER||Treatment difference|19.2|||||TWO_SIDED|95.0|-6.4|44.8||||||EOT (up to Day 14)||44.8|-6.4|
91642286|NCT05204563|183176384|OTHER||Treatment difference|-1.2|||||TWO_SIDED|95.0|-24.3|22.0||||||TOC (Day 21)||22.0|-24.3|
91642287|NCT05204563|183176384|OTHER||Treatment difference|-10.2|||||TWO_SIDED|95.0|-32.9|12.5||||||LFU (Day 28)||12.5|-32.9|
91642288|NCT05204563|183176385|OTHER||Treatment difference|6.3|||||TWO_SIDED|95.0|-7.9|20.4||||||EOT (up to Day 14)||20.4|-7.9|
91642289|NCT05204563|183176385|OTHER||Treatment difference|7.5|||||TWO_SIDED|95.0|-9.5|24.5||||||TOC (Day 21)||24.5|-9.5|
91642290|NCT05204563|183176385|OTHER||Treatment difference|8.7|||||TWO_SIDED|95.0|-8.6|26.0||||||LFU (Day 28)||26.0|-8.6|
91642291|NCT05204563|183176386|OTHER||Treatment difference|23.3|||||TWO_SIDED|95.0|4.3|42.3||||||Klebsiella pneumoniae complex EOT (up to Day 14)||42.3|4.3|
91642292|NCT05204563|183176386|OTHER||Treatment difference|7.8|||||TWO_SIDED|95.0|-13.6|29.2||||||Klebsiella pneumoniae complex TOC (Day 21)||29.2|-13.6|
91642293|NCT05204563|183176386|OTHER||Treatment difference|11.9|||||TWO_SIDED|95.0|-9.6|33.5||||||Klebsiella pneumoniae complex LFU (Day 28)||33.5|-9.6|
91642294|NCT05204563|183176386|OTHER||Treatment difference|22.5|||||TWO_SIDED|95.0|-18.6|63.7||||||Pseudomonas aeruginosa EOT (up to Day 14)||63.7|-18.6|
91642295|NCT05204563|183176386|OTHER||Treatment difference|8.7|||||TWO_SIDED|95.0|-30.2|47.6||||||Pseudomonas aeruginosa TOC (Day 21)||47.6|-30.2|
91642296|NCT05204563|183176386|OTHER||Treatment difference|0.7|||||TWO_SIDED|95.0|-37.5|38.9||||||Pseudomonas aeruginosa LFU (Day 28)||38.9|-37.5|
91642297|NCT05204563|183176386|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-46.3|46.3||||||A.calco/baumannii complex EOT (up to Day 14)||46.3|-46.3|
91642298|NCT05204563|183176386|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-46.3|46.3||||||A.calco/baumannii complex TOC (Day 21)||46.3|-46.3|
91642299|NCT05204563|183176386|OTHER||Treatment difference|9.1|||||TWO_SIDED|95.0|-38.7|56.9||||||A.calco/baumannii complex LFU (Day 28)||56.9|-38.7|
91642300|NCT05204563|183176386|OTHER||Treatment difference|-40.0|||||TWO_SIDED|95.0|-100.0|37.9||||||Enterobacter cloacae complex EOT (up to Day 14)||37.9|-100.0|
91642301|NCT05204563|183176386|OTHER||Treatment difference|-60.0|||||TWO_SIDED|95.0|-100.0|17.9||||||Enterobacter cloacae complex TOC (Day 21)||17.9|-100.0|
91642302|NCT05204563|183176386|OTHER||Treatment difference|-60.0|||||TWO_SIDED|95.0|-100.0|17.9||||||Enterobacter cloacae complex LFU (Day 28)||17.9|-100.0|
91642303|NCT05204563|183176386|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-100.0|53.3||||||Klebsiella aerogenes EOT (up to Day 14)||53.3|-100.0|
91642304|NCT05204563|183176386|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-100.0|100.0||||||Klebsiella aerogenes TOC (Day 21)||100.0|-100.0|
91642305|NCT05204563|183176386|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-100.0|100.0||||||Klebsiella aerogenes LFU (Day 28)||100.0|-100.0|
91642306|NCT05204563|183176386|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-100.0|86.7||||||Escherichia coli TOC (Day 21)||86.7|-100.0|
91642307|NCT05204563|183176386|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-100.0|86.7||||||Escherichia coli LFU (Day 28)||86.7|-100.0|
91486160|NCT01675427|182845285|SUPERIORITY_OR_OTHER|||||||0.9932|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9932
91486161|NCT01675427|182845285|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91642308|NCT05204563|183176386|OTHER||Treatment difference|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Citrobacter koseri TOC (Day 21)||100.0|-94.3|
91642309|NCT05204563|183176386|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|94.3||||||Citrobacter koseri LFU (Day 28)||94.3|-100.0|
91642310|NCT05204563|183176386|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Klebsiella oxytoca TOC (Day 21)||0.0|-100.0|
91642311|NCT05204563|183176386|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Klebsiella oxytoca LFU (Day 28)||0.0|-100.0|
91642312|NCT05204563|183176387|OTHER||Treatment difference|18.0|||||TWO_SIDED|95.0|0.4|35.5||||||Klebsiella pneumoniae complex EOT (up to Day 14)||35.5|0.4|
91642313|NCT05204563|183176387|OTHER||Treatment difference|18.5|||||TWO_SIDED|95.0|-11.3|48.3||||||A.calco/baumannii complex EOT (up to Day 14)||48.3|-11.3|
91642314|NCT05204563|183176387|OTHER||Treatment difference|9.4|||||TWO_SIDED|95.0|-27.0|45.7||||||Pseudomonas aeruginosa EOT (up to Day 14)||45.7|-27.0|
91642315|NCT05204563|183176387|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-96.1|29.4||||||Burkholderia cepacia complex EOT (up to Day 14)||29.4|-96.1|
91642316|NCT05204563|183176387|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-96.1|29.4||||||Klebsiella aerogenes EOT (up to Day 14)||29.4|-96.1|
91642317|NCT05204563|183176387|OTHER||Treatment difference|-40.0|||||TWO_SIDED|95.0|-100.0|29.6||||||Enterobacter cloacae complex EOT (up to Day 14)||29.6|-100.0|
91642318|NCT05204563|183176387|OTHER||Treatment difference|100.0|||||TWO_SIDED|95.0|0.0|100.0||||||Serratia marcescens EOT (up to Day 14)||100.0|0.0|
91642319|NCT05204563|183176387|OTHER||Treatment difference|0.3|||||TWO_SIDED|95.0|-19.4|20.0||||||Klebsiella pneumoniae complex TOC (Day 21)||20.0|-19.4|
91642320|NCT05204563|183176387|OTHER||Treatment difference|9.3|||||TWO_SIDED|95.0|-22.1|40.7||||||A.calco/baumannii complex TOC (Day 21)||40.7|-22.1|
91642321|NCT05204563|183176387|OTHER||Treatment difference|5.8|||||TWO_SIDED|95.0|-28.2|39.8||||||Pseudomonas aeruginosa TOC (Day 21)||39.8|-28.2|
91642322|NCT05204563|183176387|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-90.3|90.3||||||Burkholderia cepacia complex TOC (Day 21)||90.3|-90.3|
91642323|NCT05204563|183176387|OTHER||Treatment difference|16.7|||||TWO_SIDED|95.0|-75.0|100.0||||||Klebsiella aerogenes TOC (Day 21)||100.0|-75.0|
91642324|NCT05204563|183176387|OTHER||Treatment difference|-60.0|||||TWO_SIDED|95.0|-100.0|9.6||||||Enterobacter cloacae complex TOC (Day 21)||9.6|-100.0|
91642325|NCT05204563|183176387|OTHER||Treatment difference|-25.0|||||TWO_SIDED|95.0|-100.0|54.9||||||Escherichia coli TOC (Day 21)||54.9|-100.0|
91486162|NCT01675427|182845286|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
91486163|NCT01675427|182845286|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0020
91642326|NCT05204563|183176387|OTHER||Treatment difference|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Citrobacter koseri TOC (Day 21)||100.0|-94.3|
91642327|NCT05204563|183176387|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Klebsiella oxytoca TOC (Day 21)||0.0|-100.0|
91642328|NCT05204563|183176387|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Serratia marcescens TOC (Day 21)||0.0|-100.0|
91642329|NCT05204563|183176387|OTHER||Treatment difference|2.8|||||TWO_SIDED|95.0|-17.1|22.7||||||Klebsiella pneumoniae complex LFU (Day 28)||22.7|-17.1|
91642330|NCT05204563|183176387|OTHER||Treatment difference|3.0|||||TWO_SIDED|95.0|-28.4|34.3||||||A.calco/baumannii complex LFU (Day 28)||34.3|-28.4|
91642331|NCT05204563|183176387|OTHER||Treatment difference|-0.4|||||TWO_SIDED|95.0|-33.9|33.0||||||Pseudomonas aeruginosa LFU (Day 28)||33.0|-33.9|
91642332|NCT05204563|183176387|OTHER||Treatment difference|0.0|||||TWO_SIDED|95.0|-90.3|90.3||||||Burkholderia cepacia complex LFU (Day 28)||90.3|-90.3|
91642333|NCT05204563|183176387|OTHER||Treatment difference|16.7|||||TWO_SIDED|95.0|-75.0|100.0||||||Klebsiella aerogenes LFU (Day 28)||100.0|-75.0|
91642334|NCT05204563|183176387|OTHER||Treatment difference|-26.7|||||TWO_SIDED|95.0|-100.0|68.5||||||Enterobacter cloacae complex LFU (Day 28)||68.5|-100.0|
91642335|NCT05204563|183176387|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|36.5||||||Escherichia coli LFU (Day 28)||36.5|-100.0|
91642336|NCT05204563|183176387|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|94.3||||||Citrobacter koseri LFU (Day 28)||94.3|-100.0|
91642337|NCT05204563|183176387|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Klebsiella oxytoca LFU (Day 28)||0.0|-100.0|
91642338|NCT05204563|183176388|OTHER||Treatment difference|21.0|||||TWO_SIDED|95.0|2.4|39.6||||||Klebsiella pneumoniae complex EOT (up to Day 14)||39.6|2.4|
91642339|NCT05204563|183176388|OTHER||Treatment difference|18.2|||||TWO_SIDED|95.0|-25.7|62.0||||||Pseudomonas aeruginosa EOT (up to Day 14)||62.0|-25.7|
91642340|NCT05204563|183176388|OTHER||Treatment difference|-8.9|||||TWO_SIDED|95.0|-51.6|33.9||||||A.calco/baumannii complex EOT (up to Day 14)||33.9|-51.6|
91642341|NCT05204563|183176388|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|61.0||||||Klebsiella aerogenes EOT (up to Day 14)||61.0|-100.0|
91642342|NCT05204563|183176388|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|69.3||||||Enterobacter cloacae complex EOT (up to Day 14)||69.3|-100.0|
91642343|NCT05204563|183176388|OTHER||Treatment difference|9.7|||||TWO_SIDED|95.0|-12.7|32.1||||||Klebsiella pneumoniae complex TOC (Day 21)||32.1|-12.7|
91642344|NCT05204563|183176388|OTHER||Treatment difference|10.9|||||TWO_SIDED|95.0|-31.4|53.2||||||Pseudomonas aeruginosa TOC (Day 21)||53.2|-31.4|
91642345|NCT05204563|183176388|OTHER||Treatment difference|-8.9|||||TWO_SIDED|95.0|-51.6|33.9||||||A.calco/baumannii complex TOC (Day 21)||33.9|-51.6|
91642346|NCT05204563|183176388|OTHER||Treatment difference|16.7|||||TWO_SIDED|95.0|-100.0|100.0||||||Klebsiella aerogenes TOC (Day 21)||100|-100.0|
91642347|NCT05204563|183176388|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|69.3||||||Enterobacter cloacae complex TOC (Day 21)||69.3|-100.0|
91642348|NCT05204563|183176388|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-100.0|86.7||||||Escherichia coli TOC (Day 21)||86.7|-100.0|
91642349|NCT05204563|183176388|OTHER||Treatment difference|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Citrobacter koseri TOC (Day 21)||100.0|-94.3|
91642350|NCT05204563|183176388|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Klebsiella oxytoca TOC (Day 21)||0.0|-100.0|
91675609|NCT03395639|183245846|OTHER|Difference in adjudicated major bleeding rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
91675610|NCT03395639|183245846|OTHER|Difference in all adjudicated bleeding (major, CRNM, minor) rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|-0.24|0.25||||||||0.25|-0.24|
91675611|NCT00942331|183245854|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1707|TWO_SIDED|95.0|0.72|1.06|||Log Rank|Stratified log rank||||1.06|0.72|0.1707
91675612|NCT01194973|183245896|SUPERIORITY_OR_OTHER||LS mean change from baseline|117.68|||<|0.0001|TWO_SIDED|95.0|92.77|142.59|||ANOVA|||||142.59|92.77|<0.0001
91675613|NCT01194973|183245902|SUPERIORITY_OR_OTHER||LS mean change from baseline|102.49|||<|0.0001|TWO_SIDED|95.0|68.15|136.82|||ANOVA|||||136.82|68.15|<0.0001
91675614|NCT01338987|183245905|OTHER|||||||0.0075|||||||Wilcoxon's rank sum test|||||||0.0075
91675615|NCT03856593|183245968|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.2|-0.07|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly MME post-letter in the Outcome Measure Data table.|Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.||-0.07|-0.20|<0.05
91642351|NCT05204563|183176388|OTHER||Treatment difference|12.5|||||TWO_SIDED|95.0|-10.5|35.6||||||Klebsiella pneumoniae complex LFU (Day 28)||35.6|-10.5|
91675616|NCT03856593|183245969|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.15|-0.02|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly VME post-letter in the Outcome Measure Data table.|||-0.02|-0.15|<0.05
91675617|NCT03407118|183245971|SUPERIORITY||ratio of least square means|0.967|||||TWO_SIDED|95.0|0.803|1.17||||||||1.17|0.803|
91675618|NCT04017754|183245995|EQUIVALENCE|A p-value \<0.05 was considered significant for at difference in frequency of low p-MBL level(\<500 ug/l) between groups.|Prevalence proportion ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.34|2.38|||Chi-squared||The numerator is the risk of low p-MBL in the study sample with RPL patients and the denominator is the risk of low p-MBL in control group 1 of female blood donors.|Comparing the risk of low p-MBL level between RPL patients and MBL reference group. We hypothesized that more RPL patients had a low p-MBL level; thus, the null hypothesis was that no difference existed.||2.38|1.34|<0.001
91486164|NCT01675427|182845286|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
91486165|NCT01675427|182845286|SUPERIORITY_OR_OTHER|||||||0.7166|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7166
91642352|NCT05204563|183176388|OTHER||Treatment difference|1.8|||||TWO_SIDED|95.0|-39.9|43.5||||||Pseudomonas aeruginosa LFU (Day 28)||43.5|-39.9|
91642353|NCT05204563|183176388|OTHER||Treatment difference|2.2|||||TWO_SIDED|95.0|-45.1|49.6||||||A.calco/baumannii complex LFU (Day 28)||49.6|-45.1|
91642354|NCT05204563|183176388|OTHER||Treatment difference|16.7|||||TWO_SIDED|95.0|-100.0|100.0||||||Klebsiella aerogenes LFU (Day 28)||100.0|-100.0|
91642355|NCT05204563|183176388|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|69.3||||||Enterobacter cloacae complex LFU (Day 28)||69.3|-100.0|
91642356|NCT05204563|183176388|OTHER||Treatment difference|-33.3|||||TWO_SIDED|95.0|-100.0|86.7||||||Escherichia coli LFU (Day 28)||86.7|-100.0|
91642357|NCT05204563|183176388|OTHER||Treatment difference|-50.0|||||TWO_SIDED|95.0|-100.0|94.3||||||Citrobacter koseri LFU (Day 28)||94.3|-100.0|
91642358|NCT05204563|183176388|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Klebsiella oxytoca LFU (Day 28)||0.0|-100.0|
91642359|NCT05204563|183176389|OTHER||Treatment difference|30.3|||||TWO_SIDED|95.0|-4.2|64.8||||||A.calco/baumannii complex EOT (up to Day 14)||64.8|-4.2|
91675619|NCT03508687|183246019|OTHER|||||||0.517||||||paired t test; baseline vs. week 12 (n = 5)|t-test, 2 sided|||||||0.517
91675620|NCT03508687|183246019|OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Ranks Test (n = 5)||||||0.345
91675621|NCT02999477|183246038|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel. The test was using one-sided alpha (type I error) of 0.05. The margin is zero.||||||1|||||||McNemar|||||||1.0
91675622|NCT02999477|183246038|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel or pembrolizumab. The test was using one-sided alpha (type I error) of 0.05.||||||1|||||||McNemar|||||||1.0
91675623|NCT01635062|183246043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.3||||0.69|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower plasma renin activity (PRA), when sodium restricted, when compared to placebo.||||0.69
91675624|NCT01635062|183246044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8||||0.89|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would raise renal plasma flow, when sodium loaded, when compared to placebo.||||0.89
91675625|NCT01635062|183246045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0||||0.8|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower urine protein, when sodium loaded, when compared to placebo.||||0.80
91675626|NCT01846273|183246046|NON_INFERIORITY|pre-defined non-inferiority margin of 5 letters|Least Squares Mean|3.2|||<|0.001|ONE_SIDED|95.0|0.38||||ANCOVA||||||0.38|<0.001
91675627|NCT01846273|183246047|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91675628|NCT00359788|183246087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001|TWO_SIDED|95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
91675629|NCT00359788|183246088|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.05 liters|Mean Difference (Final Values)|0.02||||0.0042||95.0|-0.032|0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.072|-0.032|0.0042
91642360|NCT05204563|183176389|OTHER||Treatment difference|12.0|||||TWO_SIDED|95.0|-19.1|43.2||||||A.calco/baumannii complex TOC (Day 21)||43.2|-19.1|
91642361|NCT05204563|183176389|OTHER||Treatment difference|0.5|||||TWO_SIDED|95.0|-29.0|29.9||||||A.calco/baumannii complex LFU (Day 28)||29.9|-29.0|
91642362|NCT05204563|183176389|OTHER||Treatment difference|-8.3|||||TWO_SIDED|95.0|-57.9|41.1||||||EOT (up to Day 14)||41.1|-57.9|
91642363|NCT05204563|183176389|OTHER||Treatment difference|-39.8|||||TWO_SIDED|95.0|-89.1|9.4||||||Klebsiella pneumoniae complex TOC (Day 21)||9.4|-89.1|
91642364|NCT05204563|183176389|OTHER||Treatment difference|-45.1|||||TWO_SIDED|95.0|-93.8|3.5||||||Klebsiella pneumoniae complex LFU (Day 28)||3.5|-93.8|
91642365|NCT05204563|183176389|OTHER||Treatment difference|20.5|||||TWO_SIDED|95.0|-59.8|100.0||||||Pseudomonas aeruginosa EOT (up to Day 14)||100.0|-59.8|
91642366|NCT05204563|183176389|OTHER||Treatment difference|-2.6|||||TWO_SIDED|95.0|-82.0|76.9||||||Pseudomonas aeruginosa TOC (Day 21)||76.9|-82.0|
91675630|NCT00359788|183246089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
91642367|NCT05204563|183176389|OTHER||Treatment difference|-17.9|||||TWO_SIDED|95.0|-95.3|59.4||||||Pseudomonas aeruginosa LFU (Day 28)||59.4|-95.3|
91675631|NCT00359788|183246090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001||95.0|-0.114|-0.046|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.046|-0.114|<0.0001
91675632|NCT00359788|183246091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054||||0.0447||95.0|0.001|0.106|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.106|0.001|0.0447
91675633|NCT00359788|183246092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.131|||<|0.0001||95.0|-0.171|-0.092|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.092|-0.171|<0.0001
91642368|NCT05204563|183176389|OTHER||Treatment difference|-100.0|||||TWO_SIDED|95.0|-100.0|0.0||||||Escherichia coli LFU (Day 28)||0.0|-100.0|
91642369|NCT05204563|183176390|OTHER||Treatment difference|10.2|||||TWO_SIDED|95.0|-4.9|25.3||||||EOT (up to Day 14)||25.3|-4.9|
91642370|NCT05204563|183176390|OTHER||Treatment difference|3.0|||||TWO_SIDED|95.0|-13.0|19.0||||||TOC (Day 21)||19.0|-13.0|
91642371|NCT05204563|183176390|OTHER||Treatment difference|7.9|||||TWO_SIDED|95.0|-7.6|23.5||||||LFU (Day 28)||23.5|-7.6|
91642372|NCT05204563|183176391|OTHER||Treatment difference|7.5|||||TWO_SIDED|95.0|-5.8|20.8||||||EOT (up to Day 14)||20.8|-5.8|
91642373|NCT05204563|183176391|OTHER||Treatment difference|1.9|||||TWO_SIDED|95.0|-11.6|15.5||||||TOC (Day 21)||15.5|-11.6|
91642374|NCT05204563|183176391|OTHER||Treatment difference|4.1|||||TWO_SIDED|95.0|-9.2|17.4||||||LFU (Day 28)||17.4|-9.2|
91642375|NCT05204563|183176392|OTHER||Treatment difference|4.8|||||TWO_SIDED|95.0|-10.6|20.2||||||EOT (up to Day 14)||20.2|-10.6|
91642376|NCT05204563|183176392|OTHER||Treatment difference|3.2|||||TWO_SIDED|95.0|-14.0|20.4||||||TOC (Day 21)||20.4|-14.0|
91642377|NCT05204563|183176392|OTHER||Treatment difference|8.6|||||TWO_SIDED|95.0|-8.4|25.6||||||LFU (Day 28)||25.6|-8.4|
91642378|NCT05204563|183176393|OTHER||Treatment difference|11.2|||||TWO_SIDED|95.0|-14.5|36.9||||||EOT (up to Day 14)||36.9|-14.5|
91642379|NCT05204563|183176393|OTHER||Treatment difference|-5.4|||||TWO_SIDED|95.0|-28.4|17.6||||||TOC (Day 21)||17.6|-28.4|
91642380|NCT05204563|183176393|OTHER||Treatment difference|-10.2|||||TWO_SIDED|95.0|-32.9|12.5||||||LFU (Day 28)||12.5|-32.9|
91642381|NCT05643573|183176396|SUPERIORITY||Cox Proportional Hazard|3.785|||<|0.0001|TWO_SIDED|95.0|2.457|5.833|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||5.833|2.457|<.0001
91642382|NCT05643573|183176396|SUPERIORITY||Fine-Gray model|3.79|||<|0.0001|TWO_SIDED|95.0|2.46|5.839|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||5.839|2.460|<.0001
91642383|NCT05643573|183176397|SUPERIORITY||Fine-Gray model|0.319|||<|0.0001|TWO_SIDED|95.0|0.185|0.552|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||0.552|0.185|<.0001
91642384|NCT05643573|183176397|SUPERIORITY||Fine-Gray model|0.316|||<|0.0001|TWO_SIDED|95.0|0.182|0.547|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||0.547|0.182|<.0001
91642385|NCT05643573|183176398|SUPERIORITY||Fine-Gray model|1.61||||0.0011|TWO_SIDED|95.0|1.207|2.149|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||2.149|1.207|0.0011
91642386|NCT05643573|183176398|SUPERIORITY||Fine-Gray model|1.599||||0.0013|TWO_SIDED|95.0|1.197|2.134|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||2.134|1.197|0.0013
91642387|NCT02268214|183176419|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0697|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||RMM|Repeated Measures Model||||-0.28|-0.56|<0.0001
91642388|NCT02268214|183176419|SUPERIORITY||Median Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0696|<|0.0001|TWO_SIDED|95.0|-0.58|-0.31|||RMM|Repeated Measures Model||||-0.31|-0.58|<0.0001
91642389|NCT02268214|183176420|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.9555|<|0.0001|TWO_SIDED|95.0|-12.56|-4.88|||RMM|Repeated Measures Model||||-4.88|-12.56|<0.0001
91675634|NCT00359788|183246093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.152|||<|0.0001||95.0|-0.19|-0.113|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.113|-0.19|<0.0001
91675635|NCT00359788|183246094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||<|0.0001||95.0|-0.175|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.175|<0.0001
91675636|NCT00359788|183246095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
91675637|NCT00359788|183246096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.835||95.0|-0.092|0.114|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.114|-0.092|0.835
91642390|NCT02268214|183176420|SUPERIORITY||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|1.8643|<|0.0001|TWO_SIDED|95.0|-16.75|-9.43|||RMM|Repeated Measures Model||||-9.43|-16.75|<0.0001
91642391|NCT02268214|183176421|SUPERIORITY||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.3251|<|0.0001|TWO_SIDED|95.0|-3.68|-2.41|||RMM|Repeated Measures Model||||-2.41|-3.68|<0.0001
91642392|NCT02268214|183176421|SUPERIORITY||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|0.3213|<|0.0001|TWO_SIDED|95.0|-4.34|-3.08|||RMM|Repeated Measures Model||||-3.08|-4.34|<0.0001
91642393|NCT02268214|183176422|SUPERIORITY||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|2.4859|<|0.0001|TWO_SIDED|95.0|-20.22|-10.46|||RMM|Repeated Measures Model||||-10.46|-20.22|<0.0001
91642394|NCT02268214|183176422|SUPERIORITY||Mean Difference (Final Values)|-18.03|STANDARD_ERROR_OF_MEAN|2.505|<|0.0001|TWO_SIDED|95.0|-22.95|-13.11|||RMM|Repeated Measures Model||||-13.11|-22.95|<0.0001
91642395|NCT02268214|183176423|SUPERIORITY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|2.6273|<|0.0001|TWO_SIDED|95.0|-22.46|-12.14|||RMM|Repeated Measures Model||||-12.14|-22.46|<0.0001
91642396|NCT02268214|183176423|SUPERIORITY||Mean Difference (Final Values)|-18.93|STANDARD_ERROR_OF_MEAN|2.6482|<|0.0001|TWO_SIDED|95.0|-24.13|-13.73|||RMM|Repeated Measures Model||||-13.73|-24.13|<0.0001
91642397|NCT02268214|183176424|SUPERIORITY||Mean Difference (Final Values)|9.11|STANDARD_ERROR_OF_MEAN|1.1611|<|0.0001|TWO_SIDED|95.0|6.83|11.39|||RMM|Repeated Measures Model||||11.39|6.83|<0.0001
91642398|NCT02268214|183176424|SUPERIORITY||Mean Difference (Final Values)|10.65|STANDARD_ERROR_OF_MEAN|1.1689|<|0.0001|TWO_SIDED|95.0|8.35|12.94|||RMM|Repeated Measures Model||||12.94|8.35|<0.0001
91642399|NCT02268214|183176425|SUPERIORITY||Odds Ratio (OR)|3.09|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|2.1|4.56|||Regression, Logistic|||||4.56|2.10|<0.0001
91642400|NCT02268214|183176425|SUPERIORITY||Odds Ratio (OR)|3.29|STANDARD_ERROR_OF_MEAN|0.1979|<|0.0001|TWO_SIDED|95.0|2.23|4.85|||Regression, Logistic|||||4.85|2.23|<0.0001
91642401|NCT03378921|183176446|SUPERIORITY|||||||0.183||||||The threshold for statistical significance was P = 0.05|Log Rank|||The sample size (n = 26) was calculated according to the estimation that the remission rate in the FMT group would be 80% and 25% in the placebo group during the follow-up of 1 year. This difference of 55% was considered to be clinically meaningful. The significance level was selected to be 1%, and the power was set to 90%.||||0.183
91642402|NCT03677440|183176453|SUPERIORITY|||||||0.34|||||||ANOVA|||This involves a repeated-measures ANOVA testing a condition (i.e., treadmill walking exercise training vs. stretching-and-toning exercise training)-by-time (i.e., baseline, follow-up) interaction on Symbol Digit Modalities Test scores.||||.34
91642403|NCT03677440|183176454|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||||||.01
91642404|NCT03677440|183176455|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.02
91642405|NCT03677440|183176456|SUPERIORITY|||||||0.63|||||||ANOVA|||||||.63
91642406|NCT03677440|183176457|SUPERIORITY||Partial eta-squared|0.067||||0.2|TWO_SIDED||||||ANOVA|||||||.20
91642407|NCT03677440|183176458|SUPERIORITY|||||||0.96|||||||ANOVA|||||||.96
91642408|NCT03677440|183176459|SUPERIORITY|||||||0.55|||||||ANOVA|||||||.55
91642409|NCT03677440|183176460|SUPERIORITY||Partial eta-squared|0.087||||0.14|TWO_SIDED||||||ANOVA|||||||.14
91642410|NCT03677440|183176461|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
91642411|NCT03677440|183176462|SUPERIORITY||Partial eta-squared|0.048||||0.28|TWO_SIDED||||||ANOVA|||||||.28
91642412|NCT01233284|183176474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.186|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.186|0.090|<0.0001
91642413|NCT01233284|183176474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.176|0.080|<0.0001
91642414|NCT01233284|183176474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.14|0.236|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.236|0.140|<0.0001
91642415|NCT01233284|183176475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.078|0.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.173|0.078|<0.0001
91642416|NCT01233284|183176475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.179|0.084|<0.0001
91642417|NCT01233284|183176475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.096|0.191|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.191|0.096|<0.0001
91642418|NCT01233284|183176476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.175|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.175|0.083|<0.0001
91642419|NCT01233284|183176476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.172|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.172|0.081|<0.0001
91642420|NCT01233284|183176476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.132|0.224|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.224|0.132|<0.0001
91642421|NCT01233284|183176477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.027||0.0034||95.0|0.026|0.132|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.132|0.026|0.0034
91642422|NCT01233284|183176477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.027||0.0087||95.0|0.018|0.124|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.124|0.018|0.0087
91717010|NCT02849080|183326311|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.89|6.7||Unadjusted two-sided p-value for test of no difference from 1.|Pattern mixture model||Oral Semaglutide flex / Sitagliptin 100 mg.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||6.70|2.89|<0.0001
91717011|NCT02849080|183326311|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Odds Ratio (OR)|5.54|||<|0.0001|TWO_SIDED|95.0|3.54|8.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Logistic||Oral Semaglutide flex / Sitagliptin 100 mg|The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||8.68|3.54|<0.0001
91717012|NCT02849080|183326312|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixture model||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||-1.2|-2.6|<0.0001
91717013|NCT02849080|183326312|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.5|-2.9|<0.0001
91717014|NCT02849080|183326329|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.09|0.39||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.39|0.09|<0.0001
91717015|NCT02849080|183326330|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.58||||0.0175|TWO_SIDED|95.0|0.37|0.91||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||0.91|0.37|0.0175
91717016|NCT02849080|183326349|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77||||0.4381|TWO_SIDED|95.0|0.39|1.5||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||1.50|0.39|0.4381
91717017|NCT02849080|183326350|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.47||||0.079|TWO_SIDED|95.0|0.2|1.09||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.09|0.20|0.0790
91717018|NCT00596271|183326380|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. IC51+Placebo group in terms of the GMT for anti- JEV neutralizing antibody at day 56. An observed cases approach will be applied for the primary analysis||||<0.0001
91717019|NCT00596271|183326384|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. HAVRIX+Placebo group in terms of the GMT for HAV antibody at day 28. An observed cases approach will be applied for the primary analysis.||||<0.0001
91642423|NCT01233284|183176477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.085|0.19|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.190|0.085|<0.0001
91675638|NCT00359788|183246097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
91675639|NCT00359788|183246098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.157|||<|0.0001||95.0|-0.236|-0.078|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.078|-0.236|<0.0001
91675640|NCT00359788|183246099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.4386||95.0|-0.059|0.137|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.137|-0.059|0.4386
91675641|NCT00359788|183246100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282||||0.0001||95.0|-0.374|-0.191|||ANCOVA|||||-0.191|-0.374|0.0001
91675642|NCT00359788|183246101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361|||<|0.0001||95.0|-0.449|-0.274|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.274|-0.449|<0.0001
91675643|NCT00359788|183246102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|||<|0.0001||95.0|-0.375|-0.196|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.196|-0.375|<0.0001
91675644|NCT00359788|183246103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175|||<|0.0001||95.0|-0.207|-0.142|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.142|-0.207|<0.0001
91675645|NCT00359788|183246104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|||<|0.0001||95.0|-0.205|-0.131|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.131|-0.205|<0.0001
91675646|NCT00359788|183246105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|||<|0.0001||95.0|-0.221|-0.143|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.143|-0.221|<0.0001
91717020|NCT02155985|183326400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.7|TWO_SIDED|95.0|-5.5|8.8||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||8.8|-5.5|0.70
91675647|NCT00359788|183246106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||<|0.0001||95.0|-0.175|-0.097|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.097|-0.175|<0.0001
91675648|NCT00359788|183246107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||<|0.0001||95.0|-0.125|-0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.044|-0.125|<0.0001
91675649|NCT00359788|183246108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.0997||95.0|-0.076|0.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.007|-0.076|0.0997
91642424|NCT01233284|183176478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.03||0.0732||95.0|-0.005|0.113|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.113|-0.005|0.0732
91642425|NCT01233284|183176478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.03||0.0177||95.0|0.012|0.131|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.131|0.012|0.0177
91675650|NCT00359788|183246109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.101||95.0|-0.007|0.08|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.08|-0.007|0.101
91675651|NCT00359788|183246110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
91675652|NCT00359788|183246111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055||||0.0411||95.0|-0.108|-0.002|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.002|-0.108|0.0411
91675653|NCT00359788|183246112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.0354||95.0|-0.116|-0.004|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.004|-0.116|0.0354
91675654|NCT00359788|183246113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.062||||0.041||95.0|-0.121|-0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.003|-0.121|0.041
91675655|NCT00359788|183246114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.5387||95.0|-0.076|0.04|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.04|-0.076|0.5387
91675656|NCT00359788|183246115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.0372||95.0|0.004|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|0.004|0.0372
91675657|NCT00359788|183246116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.0001||95.0|0.066|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|0.066|<0.0001
91675658|NCT00359788|183246117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.108|0.216|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.216|0.108|<0.0001
91675659|NCT00359788|183246118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001||95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
91675660|NCT00359788|183246119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0023||95.0|-0.136|-0.03|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.03|-0.136|0.0023
91675661|NCT00359788|183246120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087||||0.0019||95.0|-0.142|-0.033|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.033|-0.142|0.0019
91675662|NCT00359788|183246121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0044||95.0|-0.139|-0.026|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.026|-0.139|0.0044
91675663|NCT00359788|183246122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.1182||95.0|-0.103|0.012|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.012|-0.103|0.1182
91675664|NCT00359788|183246123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.4814||95.0|-0.037|0.078||ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|ANCOVA|||||0.078|-0.037|0.4814
91675665|NCT00359788|183246124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074||||0.008||95.0|0.019|0.129|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.129|0.019|0.008
91675666|NCT00359788|183246125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||<|0.0001||95.0|0.082|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|0.082|<0.0001
91675667|NCT00359788|183246126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.0001||95.0|-0.449|-0.29|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.29|-0.449|<0.0001
91675668|NCT00359788|183246127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.356|||<|0.0001||95.0|-0.44|-0.272|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.272|-0.44|<0.0001
91675669|NCT00359788|183246128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||<|0.0001||95.0|-0.451|-0.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.264|-0.451|<0.0001
91675670|NCT00359788|183246129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.285|||<|0.0001||95.0|-0.376|-0.194|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.194|-0.376|<0.0001
91717021|NCT02155985|183326400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.14|TWO_SIDED|95.0|-1.7|13.3||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||13.3|-1.7|0.14
91675671|NCT00359788|183246130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0003||95.0|-0.261|-0.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.079|-0.261|0.0003
91675672|NCT00359788|183246131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.2992||95.0|-0.143|0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.044|-0.143|0.2992
91675673|NCT00359788|183246132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081||||0.0984||95.0|-0.015|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|-0.015|0.0984
91675674|NCT00359788|183246133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
91675675|NCT00359788|183246134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189||||0.0004||95.0|-0.293|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.293|0.0004
91675676|NCT00359788|183246135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0003||95.0|-0.314|-0.095|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.095|-0.314|0.0003
91675677|NCT00359788|183246136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832||||0.012||95.0|-0.293|-0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.072|-0.293|0.012
91675678|NCT00359788|183246137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.044||95.0|-0.219|0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.003|-0.219|0.044
91675679|NCT00359788|183246138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3634||95.0|-0.058|0.158|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.158|-0.058|0.3634
91675680|NCT00359788|183246139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163||||0.0032||95.0|0.055|0.27|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.27|0.055|0.0032
91675681|NCT00359788|183246140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|||<|0.0001||95.0|0.173|0.378|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.378|0.173|<0.0001
91675682|NCT00359788|183246141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
91675683|NCT00359788|183246142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193||||0.0002||95.0|-0.296|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.296|0.0002
91675684|NCT00359788|183246143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215|||<|0.0001||95.0|-0.323|-0.108|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.108|-0.323|<0.0001
91675685|NCT00359788|183246144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.198||||0.0006||95.0|-0.309|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.309|0.0006
91675686|NCT00359788|183246145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.0896||95.0|-0.21|0.015|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.015|-0.21|0.0896
91642426|NCT01233284|183176478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.03||0.0012||95.0|0.039|0.157|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.157|0.039|0.0012
91642427|NCT01233284|183176479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.026||0.0149||95.0|0.013|0.115|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.115|0.013|0.0149
91642428|NCT01233284|183176479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0043||95.0|0.024|0.126|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.126|0.024|0.0043
91642429|NCT01233284|183176479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.086|0.189|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.189|0.086|<0.0001
91642430|NCT01233284|183176483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.55|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|11.204|25.895|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||25.895|11.204|<0.0001
91675687|NCT00359788|183246146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8937||95.0|-0.103|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|-0.103|0.8937
91675688|NCT00359788|183246147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.0269||95.0|0.014|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|0.014|0.0269
91675689|NCT00359788|183246148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.0001||95.0|0.111|0.335|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.335|0.111|0.0001
91675690|NCT00359788|183246149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042||||0.7196||95.0|-0.275|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|-0.275|0.7196
91642431|NCT01233284|183176483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.895|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|10.55|25.24|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||25.240|10.550|<0.0001
91675691|NCT00359788|183246150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069||||0.6189||95.0|-0.343|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.343|0.6189
91675692|NCT00359788|183246151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073||||0.6197||95.0|-0.36|0.215|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.215|-0.36|0.6197
91642432|NCT01233284|183176483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.846|STANDARD_ERROR_OF_MEAN|3.739|<|0.0001||95.0|13.497|28.195|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.195|13.497|<0.0001
91642433|NCT01233284|183176484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.251|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001||95.0|13.84|28.662|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||28.662|13.840|<0.0001
91642434|NCT01233284|183176484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.577|STANDARD_ERROR_OF_MEAN|3.77||0.0001||95.0|7.166|21.988|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||21.988|7.166|0.0001
91642435|NCT01233284|183176484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.581|STANDARD_ERROR_OF_MEAN|3.773|<|0.0001||95.0|14.166|28.997|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.997|14.166|<0.0001
91642436|NCT01233284|183176485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.635||0.8574||95.0|-1.363|1.134|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||1.134|-1.363|0.8574
91642437|NCT01233284|183176485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.635||0.3954||95.0|-1.789|0.708|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.708|-1.789|0.3954
91675693|NCT00359788|183246152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112||||0.4582||95.0|-0.408|0.184|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.184|-0.408|0.4582
91675694|NCT00359788|183246153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6538||95.0|-0.376|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|-0.376|0.6538
91675695|NCT00359788|183246154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.4145||95.0|-0.495|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.495|0.4145
91675696|NCT00359788|183246155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085||||0.6048||95.0|-0.408|0.238|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.238|-0.408|0.6048
91675697|NCT00359788|183246156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.3137||95.0|-0.503|0.162|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.162|-0.503|0.3137
91675698|NCT00359788|183246157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061||||0.7195||95.0|-0.395|0.273|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.273|-0.395|0.7195
91675699|NCT00359788|183246158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.7947||95.0|-0.367|0.282|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.282|-0.367|0.7947
91486166|NCT01675427|182845286|SUPERIORITY_OR_OTHER|||||||0.3217|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3217
91642438|NCT01233284|183176485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.636||0.9034||95.0|-1.327|1.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||1.173|-1.327|0.9034
91675700|NCT00359788|183246159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.093||||0.6049||95.0|-0.446|0.26|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.26|-0.446|0.6049
91642439|NCT01233284|183176486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.233|STANDARD_ERROR_OF_MEAN|0.107||0.0296||95.0|-0.443|-0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.023|-0.443|0.0296
91642440|NCT01233284|183176486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.107||0.0454||95.0|-0.424|-0.004|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.004|-0.424|0.0454
91642441|NCT01233284|183176486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.107||0.061||95.0|-0.41|0.009|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.009|-0.410|0.0610
91642442|NCT01233284|183176487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.063||0.0183||95.0|-0.273|-0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.025|-0.273|0.0183
91642443|NCT01233284|183176487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.063||0.0288||95.0|-0.262|-0.014|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.014|-0.262|0.0288
91642444|NCT01233284|183176487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.111|STANDARD_ERROR_OF_MEAN|0.063||0.0781||95.0|-0.235|0.013|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.013|-0.235|0.0781
91642445|NCT01233284|183176488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.055||0.1303||95.0|-0.193|0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.025|-0.193|0.1303
91642446|NCT01233284|183176488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.055||0.2191||95.0|-0.177|0.041|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.041|-0.177|0.2191
91675701|NCT00359788|183246160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047||||0.8109||95.0|-0.437|0.342|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.342|-0.437|0.8109
91486167|NCT01675427|182845286|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91642447|NCT01233284|183176488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.056||0.1163||95.0|-0.196|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.022|-0.196|0.1163
91486168|NCT01675427|182845287|SUPERIORITY_OR_OTHER|||||||0.1894|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1894
91486169|NCT01675427|182845287|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0054
91642448|NCT01233284|183176489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7501||95.0|-0.073|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.052|-0.073|0.7501
91642449|NCT01233284|183176489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.032||0.8401||95.0|-0.069|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.056|-0.069|0.8401
91642450|NCT01233284|183176489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.032||0.3237||95.0|-0.094|0.031|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.031|-0.094|0.3237
91642451|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.079||0.1402|TWO_SIDED|95.0|-0.04|0.276||MMRM, adjusted for treatment, period, patient and study baseline.|Mixed Models Analysis||Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.276|-0.040|0.1402
91642452|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.079||0.0656|TWO_SIDED|95.0|-0.01|0.305|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.305|-0.010|0.0656
91642453|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.079||0.0766|TWO_SIDED|95.0|-0.015|0.299|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.299|-0.015|0.0766
91642454|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.084||0.3371|TWO_SIDED|95.0|-0.086|0.249|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.249|-0.086|0.3371
91675702|NCT00359788|183246161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527||||0.1471||95.0|-0.186|1.24|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||1.24|-0.186|0.1471
91486170|NCT01675427|182845287|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
91675703|NCT00359788|183246162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265||||0.3192||95.0|-0.258|0.788|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.788|-0.258|0.3192
91675704|NCT00359788|183246163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351||||0.182||95.0|-0.165|0.867|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.867|-0.165|0.182
91642455|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.084||0.1097|TWO_SIDED|95.0|-0.031|0.303|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.303|-0.031|0.1097
91642456|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.084||0.022|TWO_SIDED|95.0|0.029|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.363|0.029|0.0220
91642457|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.078||0.2062|TWO_SIDED|95.0|-0.056|0.256|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.256|-0.056|0.2062
91642458|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.078||0.0731|TWO_SIDED|95.0|-0.014|0.297|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.297|-0.014|0.0731
91642459|NCT01233284|183176490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.078||0.0333|TWO_SIDED|95.0|0.014|0.324|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.324|0.014|0.0333
91642460|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.099||0.2451|TWO_SIDED|95.0|-0.081|0.312|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.312|-0.081|0.2451
91642461|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.099||0.0379|TWO_SIDED|95.0|0.012|0.405|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.405|0.012|0.0379
91642462|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.099||0.0957|TWO_SIDED|95.0|-0.03|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.363|-0.030|0.0957
91642463|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.104||0.5207|TWO_SIDED|95.0|-0.139|0.273|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.273|-0.139|0.5207
91642464|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.104||0.0606|TWO_SIDED|95.0|-0.009|0.404|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.404|-0.009|0.0606
91642465|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.104||0.0855|TWO_SIDED|95.0|-0.026|0.387|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.387|-0.026|0.0855
91642466|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.099||0.3564|TWO_SIDED|95.0|-0.104|0.287|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.287|-0.104|0.3564
91642467|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.099||0.0424|TWO_SIDED|95.0|0.007|0.399|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.399|0.007|0.0424
91642468|NCT01233284|183176491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.099||0.0815|TWO_SIDED|95.0|-0.022|0.37|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.370|-0.022|0.0815
91642469|NCT05405218|183176631|SUPERIORITY||Mean Difference (Net)|0.08||||0.46|TWO_SIDED|95.0|-0.13|0.29|||Mixed Models Analysis|||||0.29|-0.13|0.46
91642470|NCT05405218|183176632|SUPERIORITY||Mean Difference (Net)|0.01||||0.92|TWO_SIDED|95.0|-0.2|0.23|||Mixed Models Analysis|||||0.23|-0.2|0.92
91675705|NCT00359788|183246164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1777||95.0|-0.166|0.893|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.893|-0.166|0.1777
91675706|NCT00359788|183246165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1805||95.0|-0.169|0.895|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.895|-0.169|0.1805
91642471|NCT05405218|183176634|SUPERIORITY||Mean Difference (Net)|0.61||||0.09|TWO_SIDED|95.0|-0.08|1.3|||Mixed Models Analysis|||||1.3|-0.08|0.09
91642472|NCT05405218|183176635|SUPERIORITY||Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.06|0.05|||Mixed Models Analysis|||||0.05|-0.06|0.9
91675707|NCT00359788|183246166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.1777||95.0|-0.17|0.913|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.913|-0.17|0.1777
91675708|NCT00359788|183246167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.5725||95.0|-0.395|0.714|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.714|-0.395|0.5725
91675709|NCT00359788|183246168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.6765||95.0|-0.449|0.69|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.69|-0.449|0.6765
91675710|NCT00359788|183246169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247||||0.3943||95.0|-0.323|0.818|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.818|-0.323|0.3943
91486171|NCT01675427|182845287|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5360
91486172|NCT01675427|182845287|SUPERIORITY_OR_OTHER|||||||0.2185|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2185
91486173|NCT01675427|182845287|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91486174|NCT01675427|182845288|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
91486175|NCT01675427|182845288|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0003
91486176|NCT01675427|182845288|SUPERIORITY_OR_OTHER|||||||0.0106|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0106
91486177|NCT01675427|182845288|SUPERIORITY_OR_OTHER|||||||0.7821|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7821
91675711|NCT00359788|183246170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291||||0.3091||95.0|-0.271|0.852|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.852|-0.271|0.3091
91675712|NCT00359788|183246171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317||||0.2911||95.0|-0.273|0.907|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.907|-0.273|0.2911
91486178|NCT01675427|182845288|SUPERIORITY_OR_OTHER|||||||0.2372|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2372
91486179|NCT01675427|182845288|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91486180|NCT01675427|182845289|SUPERIORITY_OR_OTHER|||||||0.0688|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0688
91486181|NCT01675427|182845289|SUPERIORITY_OR_OTHER|||||||0.4367|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4367
91486182|NCT01675427|182845289|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
91486183|NCT01675427|182845289|SUPERIORITY_OR_OTHER|||||||0.1951|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1951
91675713|NCT00359788|183246172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.7458||95.0|-0.549|0.766|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.766|-0.549|0.7458
91675714|NCT00359788|183246173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.698||||0.0004||95.0|4.836|16.56|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.56|4.836|0.0004
91675715|NCT00359788|183246174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.257||||0.0023||95.0|4.055|18.458|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||18.458|4.055|0.0023
91675716|NCT00359788|183246175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.772||||0.0015||95.0|4.942|20.602|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.602|4.942|0.0015
91675717|NCT00359788|183246176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.568||||0.0013||95.0|5.342|21.795|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.795|5.342|0.0013
91675718|NCT00359788|183246177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.052||||0.005||95.0|3.676|20.428|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.428|3.676|0.005
91675719|NCT00359788|183246178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.107||||0.0159||95.0|2.095|20.119|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.119|2.095|0.0159
91675720|NCT00359788|183246179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.057||||0.0219||95.0|1.613|20.501|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.501|1.613|0.0219
91675721|NCT00359788|183246180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.655||||0.0048||95.0|4.207|23.104|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||23.104|4.207|0.0048
91486184|NCT01675427|182845289|SUPERIORITY_OR_OTHER|||||||0.2927|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2927
91486185|NCT01675427|182845289|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0013
91486186|NCT01675427|182845290|SUPERIORITY_OR_OTHER|||||||0.0247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0247
91486187|NCT01675427|182845290|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0034
91642473|NCT00710840|183176662|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.||||0.07
91642474|NCT00710840|183176663|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.92
91642475|NCT00710840|183176664|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.48
91642476|NCT00710840|183176665|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.41
91642477|NCT00157820|183176666|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.31||||0.0028|TWO_SIDED|95.0|0.14|0.67|||Wilcoxon (Mann-Whitney)||An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an 'offset'.|"The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa \< 0.05 and a power of 88.8%.~The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up."||0.67|0.14|0.0028
91642478|NCT02207413|183176717|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV\_LP/ D-QIV\_IP) is ≤ 1.5.|Adjusted GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/ Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.11|0.85|
91642479|NCT02207413|183176717|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.94|1.18|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.18|0.94|
91642480|NCT02207413|183176717|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.03|||||TWO_SIDED|95.0|0.91|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.16|0.91|
91675722|NCT00359788|183246181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.231||||0.0058||95.0|4.153|24.31|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||24.31|4.153|0.0058
91675723|NCT00359788|183246182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.597||||0.0248||95.0|1.483|21.71|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.71|1.483|0.0248
91675724|NCT00359788|183246183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.001||||0.0325||95.0|0.924|21.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.079|0.924|0.0325
91486188|NCT01675427|182845290|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0017
91486189|NCT01675427|182845290|SUPERIORITY_OR_OTHER|||||||0.3346|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3346
91486190|NCT01675427|182845290|SUPERIORITY_OR_OTHER|||||||0.3215|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3215
91486191|NCT01675427|182845290|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0003
91642481|NCT02207413|183176717|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.04|||||TWO_SIDED|95.0|0.9|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.21|0.90|
91642482|NCT02207413|183176718|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT ratio|1.07|||||TWO_SIDED|95.0|0.9|1.28|||ANCOVA|||The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.28|0.90|
91675725|NCT00359788|183246184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.074||||0.0153||95.0|2.726|25.422|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||25.422|2.726|0.0153
91675726|NCT00359788|183246185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.755||||0.6105||95.0|-8.532|5.022|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||5.022|-8.532|0.6105
91675727|NCT00359788|183246186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.842||||0.8249||95.0|-6.642|8.326|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.326|-6.642|0.8249
91675728|NCT00359788|183246187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71||||0.4896||95.0|-5.001|10.421|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.421|-5.001|0.4896
91675729|NCT00359788|183246188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.898||||0.0935||95.0|-1.172|14.968|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.968|-1.172|0.0935
91486192|NCT01675427|182845291|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3609
91486193|NCT01675427|182845291|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0018
91486194|NCT01675427|182845291|SUPERIORITY_OR_OTHER|||||||0.0356|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0356
91486195|NCT01675427|182845291|SUPERIORITY_OR_OTHER|||||||0.7044|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7044
91486196|NCT01675427|182845291|SUPERIORITY_OR_OTHER|||||||0.8578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8578
91486197|NCT01675427|182845291|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0076
91675730|NCT00359788|183246189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.419||||0.4339||95.0|-5.17|12.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||12.007|-5.17|0.4339
91675731|NCT00359788|183246190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.971||||0.845||95.0|-10.74|8.799|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.799|-10.74|0.845
91486198|NCT01675427|182845292|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
91486199|NCT01675427|182845292|SUPERIORITY_OR_OTHER|||||||0.2017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2017
91486200|NCT01675427|182845292|SUPERIORITY_OR_OTHER|||||||0.5878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5878
91486201|NCT01675427|182845292|SUPERIORITY_OR_OTHER|||||||0.4144|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4144
91486202|NCT01675427|182845292|SUPERIORITY_OR_OTHER|||||||0.4492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4492
91675732|NCT00359788|183246191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194||||0.9696||95.0|-9.811|10.199|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.199|-9.811|0.9696
91675733|NCT00359788|183246192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129||||0.3252||95.0|-5.117|15.376|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||15.376|-5.117|0.3252
91486203|NCT01675427|182845292|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
91486204|NCT01675427|182845293|SUPERIORITY_OR_OTHER|||||||0.0671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0671
91675734|NCT00359788|183246193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.062||||0.452||95.0|-6.558|14.683|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.683|-6.558|0.452
91675735|NCT00359788|183246194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14||||0.4388||95.0|-6.372|14.651|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.651|-6.372|0.4388
91675736|NCT00359788|183246195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.185||||0.8288||95.0|-9.595|11.964|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||11.964|-9.595|0.8288
91675737|NCT00359788|183246196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.204||||0.4929||95.0|-7.857|16.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.264|-7.857|0.4929
91675738|NCT00359788|183246197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204||||0.0754||95.0|-0.021|0.429|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.429|-0.021|0.0754
91675739|NCT00359788|183246198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251||||0.0765||95.0|-0.027|0.528|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.528|-0.027|0.0765
91675740|NCT00359788|183246199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151||||0.163||95.0|-0.061|0.363|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.363|-0.061|0.163
91675741|NCT00359788|183246200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285||||0.0085||95.0|0.073|0.496|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.496|0.073|0.0085
91675742|NCT02220725|183246218|SUPERIORITY||Hodges-Lehman estimate of shift|-70.14|||<|0.0001|TWO_SIDED|95.0|-85.43|-65.91|||2-sided test exact Wilcoxon rank-sum tes|||||-65.91|-85.43|<0.0001
91675743|NCT02220725|183246218|SUPERIORITY||Hodges-Lehman estimate of shift|-51.87|||<|0.0001|TWO_SIDED|95.0|-57.95|-47.03|||2-sided test exact Wilcoxon rank-sum tes|||||-47.03|-57.95|<0.0001
91675744|NCT02220725|183246219|SUPERIORITY||Hodges-Lehman estimate of shift|-74.45|||<|0.0001|TWO_SIDED|95.0|-78.92|-64.45|||2-sided test exact Wilcoxon rank-sum tes|||||-64.45|-78.92|<0.0001
91675745|NCT02220725|183246221|SUPERIORITY||Hodges-Lehmann Estimate of Shift|-18.0|||<|0.0001|TWO_SIDED|95.0|-23.05|-12.73|||2-sided test exact Wilcoxon rank-sum tes|||||-12.73|-23.05|<0.0001
91675746|NCT02220725|183246222|SUPERIORITY||Hodges-Lehman estimate of shift|1142.66|||<|0.0001|TWO_SIDED|95.0|1006.1|1281.4|||2-sided test exact Wilcoxon rank-sum tes|||||1281.40|1006.10|<0.0001
91486205|NCT01675427|182845293|SUPERIORITY_OR_OTHER|||||||0.1009|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1009
91486206|NCT01675427|182845293|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0635
91526657|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16|||<|0.01|TWO_SIDED|95.0|1.37|3.4|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Median number of injected partners \>= 5 in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.40|1.37|<0.01
91675747|NCT02220725|183246222|SUPERIORITY||Hodges-Lehman estimate of shift|1205.05|||<|0.0001|TWO_SIDED|95.0|1034.17|1400.79|||2-sided test exact Wilcoxon rank-sum tes|||||1400.79|1034.17|<0.0001
91675748|NCT00103402|183246245|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|0.1||||0.99|TWO_SIDED|95.0|-11.2|11.0|||Mantel Haenszel|The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.||Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.||11.0|-11.2|0.99
91675749|NCT00103402|183246246|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|1.8||||0.9|TWO_SIDED|95.0|-9.0|2.5|||Mantel Haenszel|||Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)||2.5|-9.0|0.90
91675750|NCT00103402|183246247|SUPERIORITY||Mean Difference (Net)|-0.5||||0.7|TWO_SIDED|95.0|-2.7|1.5|||t-test, 2 sided|||Total score (0-43) change from baseline||1.5|-2.7|0.70
91675751|NCT00103402|183246247|SUPERIORITY||Mean Difference (Net)|-0.3||||0.64|TWO_SIDED|95.0|-1.4|0.8|||t-test, 2 sided|||Pain score (0-21) change from baseline||0.8|-1.4|0.64
91675752|NCT00103402|183246247|SUPERIORITY||Mean Difference (Net)|-0.2||||0.62|TWO_SIDED|95.0|-0.8|0.4|||t-test, 2 sided|||Urinary score (0-10) change from baseline||0.4|-0.8|0.62
91675753|NCT00103402|183246247|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Quality of life score (0-12) change from baseline||0.4|-0.4|.99
91675754|NCT00103402|183246248|SUPERIORITY||Mean Difference (Net)|-0.3||||0.45|TWO_SIDED|95.0|-1.8|1.2|||t-test, 2 sided|||McGill Total Score||1.2|-1.8|0.45
91675755|NCT00103402|183246248|SUPERIORITY||Mean Difference (Net)|-0.2||||0.47|TWO_SIDED|95.0|-1.4|1.0|||t-test, 2 sided|||McGill Sensory Score||1.0|-1.4|0.47
91675756|NCT00103402|183246248|SUPERIORITY||Mean Difference (Net)|-0.1||||0.89|TWO_SIDED|95.0|-0.6|0.4|||t-test, 2 sided|||McGill Affective Score||0.4|-0.6|0.89
91675757|NCT00103402|183246249|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6|TWO_SIDED|95.0|-2.3|1.3|||t-test, 2 sided|||Physical component summary (0-100) change in scores||1.3|-2.3|0.60
91675758|NCT00103402|183246249|SUPERIORITY||Mean Difference (Net)|2.1||||0.16|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||Mental component summary (0-100) Absolute Difference between Groups (95% CI)||4.6|-0.4|0.16
91486207|NCT01675427|182845293|SUPERIORITY_OR_OTHER|||||||0.4162|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4162
91675759|NCT00103402|183246250|SUPERIORITY||Mean Difference (Net)|-1.1||||0.08|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||||0.2|-2.4|0.08
91675760|NCT00103402|183246251|SUPERIORITY||Risk Difference (RD)|0.7||||0.94|TWO_SIDED|95.0|-2.6|4.0|||t-test, 2 sided|||||4.0|-2.6|0.94
91675761|NCT00103402|183246252|SUPERIORITY||Mean Difference (Net)|1.1||||0.06|TWO_SIDED|95.0|-0.3|2.5|||t-test, 2 sided|||||2.5|-0.3|0.06
91675762|NCT01663727|183246295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0007|TWO_SIDED|99.0|0.51|0.91|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.91|0.51|0.0007
91675763|NCT01663727|183246295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0046|TWO_SIDED|99.0|0.55|0.97|||Log Rank|||Unstratified Analysis.||0.97|0.55|0.0046
91675764|NCT01663727|183246295|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED||||||Wald Test|||A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.||||0.4619
91675765|NCT01663727|183246297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5877|TWO_SIDED|95.0|0.75|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.75|0.5877
91675766|NCT01663727|183246297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8004|TWO_SIDED|95.0|0.78|1.21|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.21|0.78|0.8004
91486208|NCT01675427|182845293|SUPERIORITY_OR_OTHER|||||||0.9305|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9305
91675767|NCT01663727|183246299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2745|TWO_SIDED|95.0|0.63|1.14|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.14|0.63|0.2745
91675768|NCT01663727|183246299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3616|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.17|0.65|0.3616
91675769|NCT01663727|183246300|SUPERIORITY_OR_OTHER||Difference in Response Rates|20.78|||<|0.0001|TWO_SIDED|95.0|11.45|30.11|||Fisher|||||30.11|11.45|<0.0001
91675770|NCT01663727|183246302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0038|TWO_SIDED|96.0|0.47|0.88|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.88|0.47|0.0038
91486209|NCT01675427|182845293|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0041
91486210|NCT01675427|182845294|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0059
91526658|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.19|TWO_SIDED|95.0|0.81|1.97|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days||1.97|0.81|0.19
91675771|NCT01663727|183246302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0101|TWO_SIDED|96.0|0.5|0.93|||Log Rank|||Unstratified analysis.||0.93|0.50|0.0101
91675772|NCT01663727|183246303|SUPERIORITY_OR_OTHER||Difference in Response Rates|21.53||||0.0017|TWO_SIDED|95.0|8.73|34.32|||Fisher|||||34.32|8.73|0.0017
91675773|NCT01663727|183246304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2737|TWO_SIDED|95.0|0.54|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.19|0.54|0.2737
91675774|NCT01663727|183246304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.2959|TWO_SIDED|95.0|0.56|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.19|0.56|0.2959
91675775|NCT01663727|183246305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.1783|TWO_SIDED|95.0|0.41|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.41|0.1783
91675776|NCT01663727|183246305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2429|TWO_SIDED|95.0|0.45|1.22|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.22|0.45|0.2429
91675777|NCT02944383|183246406|SUPERIORITY||Median Difference (Net)|-19.02||||0.0063|TWO_SIDED|95.0|-33.07|-4.25|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||-4.25|-33.07|0.0063
91675778|NCT02944383|183246406|SUPERIORITY||Median Difference (Net)|-7.63||||0.235|TWO_SIDED|95.0|-25.88|7.05|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||7.05|-25.88|0.2350
91675779|NCT02944383|183246407|OTHER|||||||0.1663||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1663
91675780|NCT02944383|183246407|SUPERIORITY|||||||0.6195||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6195
91642483|NCT02207413|183176718|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.39|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.39|1.00|
91675781|NCT02944383|183246407|SUPERIORITY|||||||0.0436||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0436
91675782|NCT02944383|183246407|SUPERIORITY|||||||0.5||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5000
91675783|NCT02944383|183246407|SUPERIORITY|||||||0.0007||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0007
91642484|NCT02207413|183176718|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.27|||ANCOVA|||The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.27|0.91|
91642485|NCT02207413|183176718|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.38|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate||1.38|0.99|
91642486|NCT00347776|183176750|SUPERIORITY||Cox Proportional Hazard|0.67||||0.047|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||"The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.~The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence."||0.98|0.45|.047
91642487|NCT00347776|183176751|SUPERIORITY|||||||0.19|||||||Log Rank|||"We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.~The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years."||||0.19
91642488|NCT00347776|183176752|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.1|||Regression, Logistic||Comparison group was the tetracycline group.|Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.||1.10|0.36|
91642489|NCT02074982|183176784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.01|4.02|||Regression, Logistic|||||4.02|2.01|<0.0001
91642490|NCT03292731|183176839|OTHER||Odds Ratio (OR)|1.0||||0.96|TWO_SIDED|95.0|0.93|1.08||adjusted for cerclage|Regression, Logistic|adjusted for cerclage||logistic regression comparing drug concentration to the rate of sPTB||1.08|0.93|0.96
91642491|NCT03292731|183176840|OTHER||Slope|1.11||||0.05|TWO_SIDED|95.0|0.0|2.23|||Regression, Linear|||||2.23|0.00|0.05
91642492|NCT03292731|183176841|OTHER||Slope|1.56||||0.022|TWO_SIDED|95.0|0.25|2.87|||Regression, Linear|||||2.87|0.25|0.022
91642493|NCT03292731|183176842|SUPERIORITY|||||||0.82||||||no adjustments|Fisher Exact|||Only RCT subjects utilized in neonatal safety analysis||||0.82
91642494|NCT00471237|183176846|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|0.55||0.59|TWO_SIDED|95.0|-0.78|1.37|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||1.37|-0.78|0.590
91642495|NCT00471237|183176846|SUPERIORITY||Mean Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.028|TWO_SIDED|95.0|0.28|2.44|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12||||2.44|0.28|0.028
91642496|NCT00471237|183176846|SUPERIORITY||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.54||0.011|TWO_SIDED|95.0|0.51|2.65|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.65|0.51|0.011
91642497|NCT00471237|183176846|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.55||0.012|TWO_SIDED|95.0|0.51|2.69|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.69|0.51|0.012
91642498|NCT00471237|183176854|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.38|0.48|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.48|-1.38|0.680
91642499|NCT00471237|183176854|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.48||0.192|TWO_SIDED|95.0|0.01|1.89|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.89|0.01|0.192
91675784|NCT02944383|183246407|SUPERIORITY|||||||0.1161||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1161
91675785|NCT02944383|183246407|SUPERIORITY|||||||0.183||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1830
91675786|NCT02944383|183246407|SUPERIORITY|||||||0.8762||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8762
91675787|NCT02944383|183246408|SUPERIORITY|||||||0.178||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1780
91675788|NCT02944383|183246408|SUPERIORITY|||||||0.7615||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.7615
91675789|NCT02944383|183246408|SUPERIORITY|||||||0.0162||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0162
91675790|NCT02944383|183246408|SUPERIORITY|||||||0.371||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.3710
91675791|NCT02944383|183246408|SUPERIORITY|||||||0.001||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
91675792|NCT02944383|183246408|SUPERIORITY|||||||0.0988||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0988
91642500|NCT00471237|183176854|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.12|0.73|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.73|-1.12|0.680
91675793|NCT02944383|183246408|SUPERIORITY|||||||0.2594||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2594
91675794|NCT02944383|183246408|SUPERIORITY|||||||0.9099||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9099
91675795|NCT02944383|183246408|SUPERIORITY|||||||0.0219||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0219
91675796|NCT02944383|183246408|SUPERIORITY|||||||0.3494||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3494
91675797|NCT02944383|183246409|SUPERIORITY|||||||0.0391||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0391
91675798|NCT02944383|183246409|SUPERIORITY|||||||0.2455||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2455
91675799|NCT02944383|183246409|SUPERIORITY|||||||0.026||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0260
91642501|NCT00471237|183176854|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.68|TWO_SIDED|95.0|-0.59|1.29|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.29|-0.59|0.680
91675800|NCT02944383|183246409|SUPERIORITY|||||||0.5704||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5704
91675801|NCT02944383|183246409|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
91486211|NCT01675427|182845294|SUPERIORITY_OR_OTHER|||||||0.2808|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2808
91642502|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.037|TWO_SIDED|95.0|-1.32|-0.04|||ANOVA|||Total Hip aBMD, Month 6||-0.04|-1.32|0.037
91642503|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.33||0.017|TWO_SIDED|95.0|-1.43|-0.14|||ANOVA|||Total Hip aBMD, Month 6||-0.14|-1.43|0.017
91486212|NCT01675427|182845294|SUPERIORITY_OR_OTHER|||||||0.2401|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2401
91486213|NCT01675427|182845294|SUPERIORITY_OR_OTHER|||||||0.2993|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2993
91642504|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|0.32||0|TWO_SIDED|95.0|-1.92|-0.64|||ANOVA|||Total Hip aBMD, Month 6||-0.64|-1.92|0.000
91642505|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.33||0|TWO_SIDED|95.0|-1.95|-0.65|||ANOVA|||Total Hip aBMD, Month 6||-0.65|-1.95|0.000
91642506|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.36||0.015|TWO_SIDED|95.0|-1.61|-0.17|||ANOVA|||Total Hip aBMD, Month 12||-0.17|-1.61|0.015
91642507|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.74|-0.3|||ANOVA|||Total Hip aBMD, Month 12||-0.30|-1.74|0.006
91642508|NCT00471237|183176855|SUPERIORITY||Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|0.36||0|TWO_SIDED|95.0|-2.04|-0.63|||ANOVA|||Total Hip aBMD, Month 12||-0.63|-2.04|0.000
91642509|NCT00471237|183176855|SUPERIORITY||Median Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.37||0|TWO_SIDED|95.0|-2.3|-0.84|||ANOVA|||Total Hip aBMD, Month 12||-0.84|-2.30|0.000
91642510|NCT00848965|183176868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.08|-0.68|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.68|-2.08|
91642511|NCT00848965|183176868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.309|||TWO_SIDED|95.0|-2.16|-0.93|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.93|-2.16|
91642512|NCT00848965|183176868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-2.33|-1.11|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-1.11|-2.33|
91642513|NCT00848965|183176868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|-2.6|-1.19|||||Treatment difference is presented as the difference in the adjusted means for treatment versus placebo.|||-1.19|-2.60|
91642514|NCT02951182|183176889|SUPERIORITY||Least Squares (LS) Mean Difference|8.6||||0.0016|TWO_SIDED|95.0|3.5|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.5|0.0016
91642515|NCT02951182|183176889|SUPERIORITY||Least Squares (LS) Mean Difference|10.6||||0.0001|TWO_SIDED|95.0|5.5|15.8|||Mixed-effects Model for Repeated Measure|||||15.8|5.5|0.0001
91486214|NCT01675427|182845294|SUPERIORITY_OR_OTHER|||||||0.5529|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5529
91486215|NCT01675427|182845294|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0005
91486216|NCT01675427|182845295|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91486217|NCT01675427|182845295|SUPERIORITY_OR_OTHER|||||||0.3572|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3572
91486218|NCT01675427|182845295|SUPERIORITY_OR_OTHER|||||||0.2041|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2041
91642516|NCT02951182|183176889|SUPERIORITY||Least Squares (LS) Mean Difference|12.0||||0.0001|TWO_SIDED|95.0|6.7|17.4|||Mixed-effects Model for Repeated Measure|||||17.4|6.7|0.0001
91642517|NCT02951182|183176890|SUPERIORITY||Least Squares (LS) Mean Difference|-22.3|||||TWO_SIDED|95.0|-32.1|-12.4||||||||-12.4|-32.1|
91642518|NCT02951182|183176890|SUPERIORITY||Least Squares (LS) Mean Difference|-34.7|||||TWO_SIDED|95.0|-44.7|-24.8||||||||-24.8|-44.7|
91642519|NCT02951182|183176890|SUPERIORITY||Least Squares (LS) Mean Difference|-33.4|||||TWO_SIDED|95.0|-48.5|-18.3||||||||-18.3|-48.5|
91642520|NCT02951182|183176891|SUPERIORITY||Least Squares (LS) Mean Difference|14.8|||||TWO_SIDED|95.0|5.3|24.2||||||||24.2|5.3|
91642521|NCT02951182|183176891|SUPERIORITY||Least Squares (LS) Mean Difference|19.1|||||TWO_SIDED|95.0|9.7|28.6||||||||28.6|9.7|
91642522|NCT02951182|183176891|SUPERIORITY||Least Squares (LS) Mean Difference|20.0|||||TWO_SIDED|95.0|10.8|29.1||||||||29.1|10.8|
91642523|NCT02951182|183176892|SUPERIORITY||Least Squares (LS) Mean Difference|16.1|||||TWO_SIDED|95.0|5.4|26.8||||||||26.8|5.4|
91642524|NCT02951182|183176892|SUPERIORITY||Least Squares (LS) Mean Difference|18.5|||||TWO_SIDED|95.0|7.9|29.1||||||||29.1|7.9|
91642525|NCT02951182|183176892|SUPERIORITY||Least Squares (LS) Mean Difference|20.2|||||TWO_SIDED|95.0|11.9|28.4||||||||28.4|11.9|
91642526|NCT03112720|183176896|OTHER||Odds Ratio (OR)|1.5|||<|0.01|TWO_SIDED||||||Chi-squared||||\< 0.01 study terminated because of covid and no meaningfull numbers participated|||<0.01
91642527|NCT02181673|183176989|SUPERIORITY_OR_OTHER||Percent Difference|53.4|||<|0.001|TWO_SIDED|95.0|45.8|60.9|||Cochran-Mantel-Haenszel|||||60.90|45.80|<0.001
91642528|NCT01354015|183177020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.79||0.2539|TWO_SIDED|95.0|||||ANOVA|||All statistical analysis used intent-to-treat methodology and all comparisons used a two-tailed test at the .05 level of significance. Continuous variables are reported as means and standard deviations. W||||0.2539
91642529|NCT00491322|183177026|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91486219|NCT01675427|182845295|SUPERIORITY_OR_OTHER|||||||0.0467|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0467
91642530|NCT00517868|183177027|NON_INFERIORITY|A paired student t comparison was used to assess treatment differences as measured by 11 point numerical rating scale.|Mean Difference (Final Values)|-21.14||||0.0363|TWO_SIDED|95.0|-44.43|2.16|||t-test, 1 sided|||||2.16|-44.43|0.0363
91642531|NCT06067191|183177036|OTHER||Difference in Least Square Mean|-312.28||||0.0009|TWO_SIDED|95.0|-489.17|-135.38|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-135.38|-489.17|0.0009
91675802|NCT02944383|183246409|SUPERIORITY|||||||0.0846||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0846
91675803|NCT02944383|183246409|SUPERIORITY|||||||0.1763||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1763
91642532|NCT06067191|183177037|OTHER||Difference in Least Square Mean|-1.45||||0.0047|TWO_SIDED|95.0|-2.43|-0.47|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-0.47|-2.43|0.0047
91642533|NCT06067191|183177038|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91642534|NCT06067191|183177039|OTHER|||||||0.0051|||||||Log Rank|||||||0.0051
91642535|NCT06067191|183177040|OTHER|||||||0.0077|||||||Log Rank|||||||0.0077
91642536|NCT06067191|183177041|OTHER||Difference in Least Square Mean|-87.4||||0.0268|TWO_SIDED|95.0|-164.3|-10.49|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-10.49|-164.30|0.0268
91642537|NCT06067191|183177042|OTHER||Difference in Least Square Mean|-0.99||||0.0865|TWO_SIDED|95.0|-2.13|0.15|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.15|-2.13|0.0865
91642538|NCT06067191|183177043|OTHER|||||||0.0008|||||||Log Rank|||||||0.0008
91642539|NCT06067191|183177044|OTHER|||||||0.8579|||||||Log Rank|||||||0.8579
91642540|NCT06067191|183177045|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
91642541|NCT06067191|183177046|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
91642542|NCT06067191|183177047|OTHER||Difference in Least Square Mean|-0.93||||0.203|TWO_SIDED|95.0|-2.38|0.52|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.52|-2.38|0.2030
91642543|NCT00806416|183177081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and the 70 mg alendronate market tablet, the GMR of the combination tablet/alendronate only tablet are contained within \[0.80,1.25\].|Least square mean ratio|1.03||||||90.0|0.91|1.17||||||If the true geometric mean ratio (GMR) for total urinary excretion of alendronate of 70 mg alendronate/vitamin D3 combination tablet with respect to alendronate alone is 1.00 then a sample size =208 provided 99% probability of yielding a 90% CI for the total urinary excretion GMR within the interval of \[0.80, 1.25\]. These calculations were based on the observed-pooled within-subject standard deviation (log scale) of 0.521 obtained from earlier Phase 1 studies.||1.17|0.91|
91642544|NCT00806416|183177082|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|Least square mean ratio for AUC0-120 hr|0.88||||||90.0|0.81|0.95||||||If the true GMRs for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample size=28 provided \>99% probability of yielding a 90% CI for both AUC(0-120 hr) and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC(0-120 hr) (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.81|
91675804|NCT02944383|183246409|SUPERIORITY|||||||0.5576||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5576
91675805|NCT02944383|183246409|SUPERIORITY||Median Difference (Net)|-14.66||||0.0086|TWO_SIDED|95.0|-24.68|-4.39||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.39|-24.68|0.0086
91486220|NCT01675427|182845295|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0525
91486221|NCT01675427|182845295|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91692201|NCT03296527|183279367|SUPERIORITY||Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at end-of-stimulation||0.95|0.89|<0.001
91642545|NCT00806416|183177083|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|least-squares mean for Cmax|0.89||||||90.0|0.84|0.95||||||If the true GMR ratios for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample of N=28 provided \>99% probability of yielding a 90% CI for both AUC0-120 hr and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC0-120 hr (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.84|
91526659|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.01|TWO_SIDED|95.0|1.01|2.55|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Injected with someone else's used needle/syringe in the past 30 days|Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 days||2.55|1.01|<0.01
91642546|NCT04035694|183177090|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
91642547|NCT04035694|183177091|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.11
91642548|NCT04035694|183177092|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
91642549|NCT04035694|183177093|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.38|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.38
91642550|NCT04035694|183177094|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
91642551|NCT04035694|183177095|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.09|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.09
91642552|NCT04035694|183177096|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.40
91675806|NCT02944383|183246409|SUPERIORITY||Mean Difference (Net)|-5.06||||0.1516|TWO_SIDED|95.0|-15.02|3.64||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.64|-15.02|0.1516
91675807|NCT02944383|183246410|SUPERIORITY|||||||0.0386||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0386
91675808|NCT02944383|183246410|SUPERIORITY|||||||0.1206||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1206
91642553|NCT04035694|183177097|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
91675809|NCT02944383|183246410|SUPERIORITY|||||||0.0364||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0364
91675810|NCT02944383|183246410|SUPERIORITY|||||||0.4312||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4312
91642554|NCT04035694|183177098|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.66|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.66
91642555|NCT04035694|183177099|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
91642556|NCT04035694|183177100|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.52|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.52
91642557|NCT04035694|183177101|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
91642558|NCT04035694|183177102|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.21|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.21
91642559|NCT04035694|183177103|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.27|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.27
91642560|NCT04035694|183177104|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
91675811|NCT02944383|183246410|SUPERIORITY|||||||0.001||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
91675812|NCT02944383|183246410|SUPERIORITY|||||||0.0407||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0407
91675813|NCT02944383|183246410|SUPERIORITY|||||||0.1433||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1433
91486222|NCT01675427|182845296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91675814|NCT02944383|183246410|SUPERIORITY|||||||0.2866||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2866
91675815|NCT02944383|183246410|SUPERIORITY|||||||0.0056||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0056
91675816|NCT02944383|183246410|SUPERIORITY|||||||0.0789||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0789
91675817|NCT02944383|183246411|SUPERIORITY|||||||0.0277||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0277
91675818|NCT02944383|183246411|SUPERIORITY|||||||0.2502||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2502
91675819|NCT02944383|183246411|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0161
91675820|NCT02944383|183246411|SUPERIORITY|||||||0.6567||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6567
91486223|NCT01675427|182845296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
91486224|NCT01675427|182845296|SUPERIORITY_OR_OTHER|||||||0.5275|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5275
91486225|NCT01675427|182845296|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.6593
91486226|NCT01675427|182845296|SUPERIORITY_OR_OTHER|||||||0.0372|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0372
91486227|NCT01675427|182845296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91486228|NCT01675427|182845297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91675821|NCT02944383|183246411|SUPERIORITY|||||||0.001||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
91675822|NCT02944383|183246411|SUPERIORITY|||||||0.1257||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1257
91675823|NCT02944383|183246411|SUPERIORITY|||||||0.144||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1440
91675824|NCT02944383|183246411|SUPERIORITY|||||||0.7642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7642
91675825|NCT02944383|183246411|SUPERIORITY||Median Difference (Net)|-16.4||||0.0107|TWO_SIDED|95.0|-28.31|-4.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.51|-28.31|0.0107
91675826|NCT02944383|183246411|SUPERIORITY||Median Difference (Net)|-5.32||||0.2466|TWO_SIDED|95.0|-16.73|5.52||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.52|-16.73|0.2466
91675827|NCT02944383|183246412|SUPERIORITY|||||||0.0211||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0211
91675828|NCT02944383|183246412|SUPERIORITY|||||||0.1304||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1304
91675829|NCT02944383|183246412|SUPERIORITY|||||||0.0318||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0318
91486229|NCT01675427|182845297|SUPERIORITY_OR_OTHER|||||||0.3857|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3857
91675830|NCT02944383|183246412|SUPERIORITY|||||||0.4607||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4607
91486230|NCT01675427|182845297|SUPERIORITY_OR_OTHER|||||||0.2356|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2356
91675831|NCT02944383|183246412|SUPERIORITY|||||||0.0012||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0012
91675832|NCT02944383|183246412|SUPERIORITY|||||||0.0592||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0592
91675833|NCT02944383|183246412|SUPERIORITY|||||||0.117||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1170
91675834|NCT02944383|183246412|SUPERIORITY|||||||0.3138||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3138
91675835|NCT02944383|183246412|SUPERIORITY|||||||0.009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0090
91486231|NCT01675427|182845297|SUPERIORITY_OR_OTHER|||||||0.7993|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.7993
91675836|NCT02944383|183246412|SUPERIORITY|||||||0.1317||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1317
91486232|NCT01675427|182845297|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2164
91675837|NCT02944383|183246413|SUPERIORITY|||||||0.2395||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2395
91675838|NCT02944383|183246413|SUPERIORITY|||||||0.638||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6380
91675839|NCT02944383|183246413|SUPERIORITY|||||||0.7468||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7468
91675840|NCT02944383|183246413|SUPERIORITY|||||||0.8483||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8483
91486233|NCT01675427|182845297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91486234|NCT01675427|182845298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91486235|NCT01675427|182845298|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0001
91486236|NCT01675427|182845298|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.4820
91486237|NCT01675427|182845298|SUPERIORITY_OR_OTHER|||||||0.8668|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.8668
91486238|NCT01675427|182845298|SUPERIORITY_OR_OTHER|||||||0.2032|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2032
91486239|NCT01675427|182845298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91486240|NCT01675427|182845299|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0103
91486241|NCT01675427|182845299|SUPERIORITY_OR_OTHER|||||||0.8373|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.8373
91675841|NCT02944383|183246413|SUPERIORITY|||||||0.0008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0008
91675842|NCT02944383|183246413|SUPERIORITY|||||||0.0938||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0938
91675843|NCT02944383|183246413|SUPERIORITY|||||||0.3201||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3201
91675844|NCT02944383|183246413|SUPERIORITY|||||||0.901||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9010
91675845|NCT02944383|183246413|SUPERIORITY||Median Difference (Net)|-19.31||||0.0156|TWO_SIDED|95.0|-39.06|-1.49||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.49|-39.06|0.0156
91675846|NCT02944383|183246413|SUPERIORITY||Median Difference (Net)|-5.98||||0.3456|TWO_SIDED|95.0|-28.51|17.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||17.26|-28.51|0.3456
91675847|NCT02944383|183246414|SUPERIORITY|||||||0.3714||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.3714
91675848|NCT02944383|183246414|SUPERIORITY|||||||0.4415||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.4415
91675849|NCT02944383|183246414|SUPERIORITY|||||||0.7902||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7902
91486242|NCT01675427|182845299|SUPERIORITY_OR_OTHER|||||||0.3672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.3672
91486243|NCT01675427|182845300|SUPERIORITY_OR_OTHER|||||||0.0637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0637
91675850|NCT02944383|183246414|SUPERIORITY|||||||0.6999||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6999
91675851|NCT02944383|183246414|SUPERIORITY|||||||0.0015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0015
91675852|NCT02944383|183246414|SUPERIORITY|||||||0.0796||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0796
91486244|NCT01675427|182845300|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0474
91486245|NCT01675427|182845300|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91486246|NCT01675427|182845301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91486247|NCT01675427|182845301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
91486248|NCT01675427|182845301|SUPERIORITY_OR_OTHER|||||||0.5522|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5522
91486249|NCT01675427|182845302|SUPERIORITY_OR_OTHER|||||||0.5117|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.5117
91486250|NCT01675427|182845302|SUPERIORITY_OR_OTHER|||||||0.3437|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3437
91486251|NCT01675427|182845302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91642561|NCT04035694|183177105|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.23|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.23
91642562|NCT04035694|183177106|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
91642563|NCT04035694|183177107|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
91486252|NCT01675427|182845303|SUPERIORITY_OR_OTHER|||||||0.0381|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0381
91642564|NCT04035694|183177108|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|0.72||0.19|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.19
91642565|NCT04035694|183177109|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.59||0.92|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.92
91642566|NCT04035694|183177110|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
91642567|NCT04035694|183177111|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
91642568|NCT04035694|183177112|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
91642569|NCT04035694|183177113|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.82|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.82
91642570|NCT04035694|183177114|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.97
91486253|NCT01675427|182845303|SUPERIORITY_OR_OTHER|||||||0.6852|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.6852
91486254|NCT01675427|182845303|SUPERIORITY_OR_OTHER|||||||0.1185|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.1185
91486255|NCT01675427|182845304|SUPERIORITY_OR_OTHER|||||||0.2611|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.2611
91486256|NCT01675427|182845304|SUPERIORITY_OR_OTHER|||||||0.6059|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.6059
91675853|NCT02944383|183246414|SUPERIORITY|||||||0.4225||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4225
91675854|NCT02944383|183246414|SUPERIORITY|||||||0.7687||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7687
91675855|NCT02944383|183246414|SUPERIORITY|||||||0.0437||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0437
91675856|NCT02944383|183246414|SUPERIORITY|||||||0.2735||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2735
91675857|NCT02944383|183246415|SUPERIORITY|||||||0.1042||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1042
91675858|NCT02944383|183246415|SUPERIORITY|||||||0.6204||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6204
91675859|NCT02944383|183246415|SUPERIORITY|||||||0.8659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8659
91486257|NCT01675427|182845304|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0001
91486258|NCT01675427|182845305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91486259|NCT01675427|182845305|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0048
91675860|NCT02944383|183246415|SUPERIORITY|||||||0.9658||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9658
91486260|NCT01675427|182845305|SUPERIORITY_OR_OTHER|||||||0.5127|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5127
91486261|NCT01675427|182845306|SUPERIORITY_OR_OTHER|||||||0.3465|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.3465
91486262|NCT01675427|182845306|SUPERIORITY_OR_OTHER|||||||0.7358|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7358
91486263|NCT01675427|182845306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91486264|NCT01675427|182845307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486265|NCT01675427|182845308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486266|NCT01675427|182845309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
91486267|NCT01675427|182845310|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||0.0066
91486268|NCT01675427|182845311|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0018
91675861|NCT02944383|183246415|SUPERIORITY|||||||0.8238||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8238
91675862|NCT02944383|183246415|SUPERIORITY|||||||0.4874||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4874
91675863|NCT02944383|183246415|SUPERIORITY|||||||0.9467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9467
91717022|NCT00402727|183326420|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population|Difference of cure rates (in percent)|-1.0||||||95.0|-5.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-5.3|
91717023|NCT00402727|183326421|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|1.3||||||95.0|-3.8|6.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||6.3|-3.8|
91717024|NCT00402727|183326422|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|-0.7||||||95.0|-1.6|0.6|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||0.6|-1.6|
91717025|NCT00402727|183326423|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|1.4||||||95.0|-1.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-1.3|
91717026|NCT00402727|183326424|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|0.2||||||95.0|-3.1|2.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.4|-3.1|
91717027|NCT00402727|183326425|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|1.6||||||95.0|-2.4|5.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.3|-2.4|
91717028|NCT00402727|183326426|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.5||||||95.0|-17.0|-1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-1.4|-17.0|
91717029|NCT00402727|183326427|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.6||||||95.0|-17.6|-0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.4|-17.6|
91717030|NCT00402727|183326428|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-3.9||||||95.0|-9.5|1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||1.4|-9.5|
91717031|NCT00402727|183326429|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-5.6||||||95.0|-11.4|-0.8|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.8|-11.4|
91717032|NCT00402727|183326430|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-0.1||||||95.0|-6.9|5.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.4|-6.9|
91717033|NCT00402727|183326431|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-2.9||||||95.0|-9.3|2.2|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.2|-9.3|
91717034|NCT04794751|183326457|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.0106|||TWO_SIDED|95.0|-0.039|0.002|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Distance (4m)||0.002|-0.039|
91486269|NCT01675427|182845311|SUPERIORITY_OR_OTHER|||||||0.0425|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0425
91486270|NCT01675427|182845311|SUPERIORITY_OR_OTHER|||||||0.9829|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9829
91486271|NCT01675427|182845311|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6700
91675864|NCT02944383|183246415|SUPERIORITY|||||||0.7467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7467
91675865|NCT02944383|183246415|SUPERIORITY||Median Difference (Net)|-0.41||||0.9081|TWO_SIDED|95.0|-10.77|10.75||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||10.75|-10.77|0.9081
91675866|NCT02944383|183246415|SUPERIORITY||Median Difference (Net)|-2.38||||0.548|TWO_SIDED|95.0|-11.82|6.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.86|-11.82|0.5480
91675867|NCT02944383|183246416|SUPERIORITY|||||||0.1485||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1485
91675868|NCT02944383|183246416|SUPERIORITY|||||||0.6008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6008
91675869|NCT02944383|183246416|SUPERIORITY|||||||0.9409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9409
91675870|NCT02944383|183246416|SUPERIORITY|||||||0.9292||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9292
91486272|NCT01675427|182845311|SUPERIORITY_OR_OTHER|||||||0.7672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7672
91486273|NCT01675427|182845311|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0067
91675871|NCT02944383|183246416|SUPERIORITY|||||||0.8455||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8455
91675872|NCT02944383|183246416|SUPERIORITY|||||||0.5256||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5256
91675873|NCT02944383|183246416|SUPERIORITY|||||||0.9217||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9217
91486274|NCT01675427|182845312|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0003
91486275|NCT01675427|182845312|SUPERIORITY_OR_OTHER|||||||0.1637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1637
91486276|NCT01675427|182845312|SUPERIORITY_OR_OTHER|||||||0.8579|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.8579
91486277|NCT01675427|182845312|SUPERIORITY_OR_OTHER|||||||0.6935|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6935
91486278|NCT01675427|182845312|SUPERIORITY_OR_OTHER|||||||0.8124|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8124
91675874|NCT02944383|183246416|SUPERIORITY|||||||0.7401||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7401
91675875|NCT02944383|183246416|SUPERIORITY|||||||0.9386||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9386
91675876|NCT02944383|183246416|SUPERIORITY|||||||0.6352||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6352
91675877|NCT02944383|183246417|SUPERIORITY|||||||0.0165||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0165
91675878|NCT02944383|183246417|SUPERIORITY|||||||0.3075||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3075
91675879|NCT02944383|183246417|SUPERIORITY|||||||0.1069||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1069
91675880|NCT02944383|183246417|SUPERIORITY|||||||0.6101||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6101
91675881|NCT02944383|183246417|SUPERIORITY||Median Difference (Net)|-12.04||||0.0351|TWO_SIDED|95.0|-23.79|-1.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.08|-23.79|0.0351
91675882|NCT02944383|183246417|SUPERIORITY||Median Difference (Net)|-3.15||||0.3746|TWO_SIDED|95.0|-9.86|4.25||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.25|-9.86|0.3746
91675883|NCT02944383|183246418|SUPERIORITY|||||||0.0133||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0133
91675884|NCT02944383|183246418|SUPERIORITY|||||||0.2044||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2044
91675885|NCT02944383|183246418|SUPERIORITY|||||||0.0855||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0855
91675886|NCT02944383|183246418|SUPERIORITY|||||||0.5114||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5114
91675887|NCT02944383|183246418|SUPERIORITY|||||||0.0289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0289
91675888|NCT02944383|183246418|SUPERIORITY|||||||0.295||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2950
91675889|NCT02944383|183246419|SUPERIORITY|||||||0.1992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1992
91675890|NCT02944383|183246419|SUPERIORITY|||||||0.9945||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9945
91675891|NCT02944383|183246419|SUPERIORITY|||||||0.5139||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5139
91486279|NCT01675427|182845312|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91675892|NCT02944383|183246419|SUPERIORITY|||||||0.8085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8085
91717035|NCT04794751|183326457|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.0127|||TWO_SIDED|95.0|-0.032|0.018|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Intermediate (64cm)||0.018|-0.032|
91675893|NCT02944383|183246419|SUPERIORITY||Median Difference (Net)|-0.77||||0.7644|TWO_SIDED|95.0|-6.31|4.85||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.85|-6.31|0.7644
91675894|NCT02944383|183246419|SUPERIORITY||Mean Difference (Net)|1.33||||0.9499|TWO_SIDED|95.0|-4.34|6.66||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.66|-4.34|0.9499
91675895|NCT02944383|183246420|SUPERIORITY|||||||0.1521||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1521
91675896|NCT02944383|183246420|SUPERIORITY|||||||0.8982||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8982
91675897|NCT02944383|183246420|SUPERIORITY|||||||0.6228||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6228
91675898|NCT02944383|183246420|SUPERIORITY|||||||0.9622||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9622
91675899|NCT02944383|183246420|SUPERIORITY|||||||0.6643||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6643
91675900|NCT02944383|183246420|SUPERIORITY|||||||0.9071||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9071
91675901|NCT02944383|183246421|SUPERIORITY|||||||0.5647||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5647
91675902|NCT02944383|183246421|SUPERIORITY|||||||0.1073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1073
91675903|NCT02944383|183246421|SUPERIORITY|||||||0.3858||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3858
91675904|NCT02944383|183246421|SUPERIORITY|||||||0.0916||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0916
91675905|NCT02944383|183246421|SUPERIORITY||Median Difference (Net)|0.0||||0.9473|TWO_SIDED|95.0|-5.56|5.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.26|-5.56|0.9473
91675906|NCT02944383|183246421|SUPERIORITY||Median Difference (Net)|4.54||||0.0911|TWO_SIDED|95.0|-1.83|9.95||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||9.95|-1.83|0.0911
91675907|NCT02944383|183246422|SUPERIORITY|||||||0.4623||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4623
91675908|NCT02944383|183246422|SUPERIORITY|||||||0.1678||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1678
91675909|NCT02944383|183246422|SUPERIORITY|||||||0.439||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4390
91675910|NCT02944383|183246422|SUPERIORITY|||||||0.129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1290
91675911|NCT02944383|183246422|SUPERIORITY|||||||0.9627||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9627
91675912|NCT02944383|183246422|SUPERIORITY|||||||0.0911||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0911
91675913|NCT02944383|183246423|SUPERIORITY|||||||0.2882||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2882
91675914|NCT02944383|183246423|SUPERIORITY|||||||0.4474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4474
91486280|NCT01675427|182845313|SUPERIORITY_OR_OTHER|||||||0.1834|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1834
91486281|NCT01675427|182845313|SUPERIORITY_OR_OTHER|||||||0.8543|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.8543
91675915|NCT02944383|183246423|SUPERIORITY|||||||0.7875||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7875
91675916|NCT02944383|183246423|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0600
91675917|NCT02944383|183246423|SUPERIORITY||Median Difference (Net)|0.0||||0.9832|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.9832
91675918|NCT02944383|183246423|SUPERIORITY||Median Difference (Net)|0.0||||0.1352|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.1352
91675919|NCT02944383|183246424|SUPERIORITY|||||||0.2857||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|ranked ANCOVA|||Week 10||||0.2857
91675920|NCT02944383|183246424|SUPERIORITY|||||||0.4486||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4486
91675921|NCT02944383|183246424|SUPERIORITY|||||||0.764||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7640
91675922|NCT02944383|183246424|SUPERIORITY|||||||0.056||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0560
91675923|NCT02944383|183246424|SUPERIORITY|||||||0.9954||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9954
91675924|NCT02944383|183246424|SUPERIORITY|||||||0.1298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1298
91675925|NCT02944383|183246425|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.0161
91675926|NCT02944383|183246425|SUPERIORITY|||||||0.1806||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.1806
91675927|NCT02944383|183246425|SUPERIORITY|||||||0.2657||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.2657
91675928|NCT02944383|183246425|SUPERIORITY|||||||0.5996||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.5996
91675929|NCT02944383|183246425|SUPERIORITY||Median Difference (Net)|-11.39||||0.027|TWO_SIDED|95.0|-28.81|2.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.08|-28.81|0.0270
91675930|NCT02944383|183246425|SUPERIORITY||Median Difference (Net)|-0.92||||0.5263|TWO_SIDED|95.0|-16.88|15.5||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||15.50|-16.88|0.5263
91675931|NCT02944383|183246426|SUPERIORITY|||||||0.0345||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0345
91675932|NCT02944383|183246426|SUPERIORITY|||||||0.2709||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2709
91486282|NCT01675427|182845313|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.1485
91675933|NCT02944383|183246426|SUPERIORITY|||||||0.3255||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3255
91675934|NCT02944383|183246426|SUPERIORITY|||||||0.7391||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7391
91486283|NCT01675427|182845313|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0260
91526660|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07|||<|0.01|TWO_SIDED|95.0|1.79|5.27|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days||5.27|1.79|<0.01
91675935|NCT02944383|183246426|SUPERIORITY|||||||0.0808||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0808
91675936|NCT02944383|183246426|SUPERIORITY|||||||0.6509||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6509
91675937|NCT02944383|183246427|SUPERIORITY|||||||0.0004||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0004
91675938|NCT02944383|183246427|SUPERIORITY|||||||0.0412||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0412
91675939|NCT02944383|183246427|SUPERIORITY|||||||0.1937||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1937
91675940|NCT02944383|183246427|SUPERIORITY|||||||0.474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4740
91675941|NCT02944383|183246427|SUPERIORITY||Median Difference (Net)|-14.32||||0.0116|TWO_SIDED|95.0|-34.13|3.89||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.89|-34.13|0.0116
91675942|NCT02944383|183246427|SUPERIORITY||Median Difference (Net)|-3.66||||0.1109|TWO_SIDED|95.0|-23.85|14.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.26|-23.85|0.1109
91717036|NCT04794751|183326457|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.0124|||TWO_SIDED|95.0|-0.034|0.015|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Near (40cm)||0.015|-0.034|
91675943|NCT02944383|183246428|SUPERIORITY|||||||0.0002||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0002
91675944|NCT02944383|183246428|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0161
91675945|NCT02944383|183246428|SUPERIORITY|||||||0.3043||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3043
91675946|NCT02944383|183246428|SUPERIORITY|||||||0.4639||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4639
91675947|NCT02944383|183246428|SUPERIORITY|||||||0.021||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0210
91486284|NCT01675427|182845313|SUPERIORITY_OR_OTHER|||||||0.5317|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5317
91486285|NCT01675427|182845313|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0005
91486286|NCT01675427|182845314|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91486287|NCT01675427|182845314|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
91486288|NCT01675427|182845314|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.4423
91486289|NCT01675427|182845314|SUPERIORITY_OR_OTHER|||||||0.3824|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.3824
91486290|NCT01675427|182845314|SUPERIORITY_OR_OTHER|||||||0.5246|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5246
91486291|NCT01675427|182845314|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91526661|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.01|TWO_SIDED|95.0|1.34|3.32|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Shared cooker/spook to prepare drugs in the past 30 days|Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviors||3.32|1.34|<0.01
91642571|NCT04035694|183177115|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
91642572|NCT04035694|183177116|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.69
91642573|NCT04035694|183177117|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.63|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.63
91642574|NCT04035694|183177118|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.79
91642575|NCT04035694|183177119|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.93|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.93
91642576|NCT04035694|183177120|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.98|STANDARD_ERROR_OF_MEAN|2.18||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
91642577|NCT04035694|183177121|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.11
91642578|NCT04035694|183177122|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.38||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
91486292|NCT01675427|182845315|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
91486293|NCT01675427|182845315|SUPERIORITY_OR_OTHER|||||||0.1947|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1947
91486294|NCT01675427|182845315|SUPERIORITY_OR_OTHER|||||||0.0226|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.0226
91675948|NCT02944383|183246428|SUPERIORITY|||||||0.0992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0992
91675949|NCT02944383|183246429|SUPERIORITY|||||||0.1512||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1512
91675950|NCT02944383|183246429|SUPERIORITY|||||||0.84||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8400
91675951|NCT02944383|183246429|SUPERIORITY|||||||0.0244||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0244
91675952|NCT02944383|183246429|SUPERIORITY|||||||0.1803||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1803
91675953|NCT02944383|183246429|SUPERIORITY||Median Difference (Net)|-24.41||||0.0307|TWO_SIDED|95.0|-42.73|-9.94||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-9.94|-42.73|0.0307
91675954|NCT02944383|183246429|SUPERIORITY||Median Difference (Net)|-8.73||||0.5326|TWO_SIDED|95.0|-23.33|7.68||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.68|-23.33|0.5326
91675955|NCT02944383|183246430|SUPERIORITY|||||||0.1705||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1705
91675956|NCT02944383|183246430|SUPERIORITY|||||||0.9193||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9193
91675957|NCT02944383|183246430|SUPERIORITY|||||||0.0224||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0224
91486295|NCT01675427|182845316|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.1158
91675958|NCT02944383|183246430|SUPERIORITY|||||||0.2387||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2387
91675959|NCT02944383|183246430|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0600
91486296|NCT01675427|182845316|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3675
91486297|NCT01675427|182845316|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0948
91486298|NCT01675427|182845317|SUPERIORITY_OR_OTHER|||||||0.1236|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1236
91486299|NCT01675427|182845317|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0119
91486300|NCT01675427|182845317|SUPERIORITY_OR_OTHER|||||||0.7472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.7472
91486301|NCT01675427|182845318|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.9734
91486302|NCT01675427|182845318|SUPERIORITY_OR_OTHER|||||||0.8303|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8303
91486303|NCT01675427|182845318|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0006
91486304|NCT01675427|182845319|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0065
91486305|NCT01675427|182845319|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.9999
91486306|NCT01675427|182845319|SUPERIORITY_OR_OTHER|||||||0.3472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.3472
91486307|NCT01675427|182845320|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.2564
91675960|NCT02944383|183246430|SUPERIORITY|||||||0.6878||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6878
91675961|NCT02944383|183246431|SUPERIORITY|||||||0.0298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0298
91675962|NCT02944383|183246431|SUPERIORITY|||||||0.0196||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0196
91675963|NCT02944383|183246431|SUPERIORITY|||||||0.2219||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2219
91675964|NCT02944383|183246431|SUPERIORITY|||||||0.4078||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4078
91675965|NCT02944383|183246431|SUPERIORITY||Median Difference (Net)|-15.34||||0.0605|TWO_SIDED|95.0|-31.68|1.3||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||1.30|-31.68|0.0605
91675966|NCT02944383|183246431|SUPERIORITY||Median Difference (Net)|-4.08||||0.1768|TWO_SIDED|95.0|-19.91|7.32||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.32|-19.91|0.1768
91675967|NCT02944383|183246432|SUPERIORITY|||||||0.0084||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0084
91675968|NCT02944383|183246432|SUPERIORITY|||||||0.0047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0047
91675969|NCT02944383|183246432|SUPERIORITY|||||||0.1574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1574
91486308|NCT01675427|182845320|SUPERIORITY_OR_OTHER|||||||0.7361|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7361
91486309|NCT01675427|182845320|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
91717037|NCT04794751|183326458|NON_INFERIORITY|Non-inferiority was declared if the lower limit of the 95% confidence interval for the least-square mean difference was greater than -5.|least-square mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-4.6|4.8|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|||4.8|-4.6|
91486310|NCT01675427|182845321|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0097
91486311|NCT01675427|182845321|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
91486312|NCT01675427|182845321|SUPERIORITY_OR_OTHER|||||||0.9778|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9778
91486313|NCT01675427|182845322|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0151
91675970|NCT02944383|183246432|SUPERIORITY|||||||0.3235||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3235
91675971|NCT02944383|183246432|SUPERIORITY|||||||0.0367||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0367
91486314|NCT01675427|182845322|SUPERIORITY_OR_OTHER|||||||0.1052|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.1052
91675972|NCT02944383|183246432|SUPERIORITY|||||||0.0948||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0948
91675973|NCT02944383|183246433|SUPERIORITY|||||||0.0037||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0037
91675974|NCT02944383|183246433|SUPERIORITY|||||||0.1328||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1328
91675975|NCT02944383|183246433|SUPERIORITY|||||||0.4364||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4364
91675976|NCT02944383|183246433|SUPERIORITY|||||||0.8129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8129
91675977|NCT02944383|183246433|SUPERIORITY||Median Difference (Net)|-15.29||||0.0347|TWO_SIDED|95.0|-36.54|2.35||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.35|-36.54|0.0347
91675978|NCT02944383|183246433|SUPERIORITY||Median Difference (Net)|-2.14||||0.3617|TWO_SIDED|95.0|-25.78|23.62||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||23.62|-25.78|0.3617
91675979|NCT02944383|183246434|SUPERIORITY|||||||0.0085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0085
91675980|NCT02944383|183246434|SUPERIORITY|||||||0.2112||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2112
91675981|NCT02944383|183246434|SUPERIORITY|||||||0.7301||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7301
91675982|NCT02944383|183246434|SUPERIORITY|||||||0.6283||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6283
91675983|NCT02944383|183246434|SUPERIORITY|||||||0.0919||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0919
91486315|NCT01675427|182845322|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0007
91675984|NCT02944383|183246434|SUPERIORITY|||||||0.5497||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.5497
91675985|NCT02944383|183246435|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
91675986|NCT02944383|183246435|SUPERIORITY|||||||0.0351||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0351
91675987|NCT02944383|183246435|SUPERIORITY|||||||0.1561||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1561
91675988|NCT02944383|183246435|SUPERIORITY|||||||0.0268||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0268
91675989|NCT02944383|183246435|SUPERIORITY||Median Difference (Net)|-22.3||||0.0516|TWO_SIDED|95.0|-42.96|-1.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.67|-42.96|0.0516
91692202|NCT03296527|183279368|SUPERIORITY||Mean ratio|1.03||||0.184|TWO_SIDED|95.0|0.99|1.07||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at oocyte retrieval visit||1.07|0.99|0.184
91486316|NCT01675427|182845323|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91675990|NCT02944383|183246435|SUPERIORITY||Median Difference (Net)|-13.06||||0.0125|TWO_SIDED|95.0|-32.83|4.88||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.88|-32.83|0.0125
91675991|NCT02944383|183246436|SUPERIORITY|||||||0.0023||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0023
91675992|NCT02944383|183246436|SUPERIORITY|||||||0.0356||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0356
91486317|NCT01675427|182845323|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0012
91486318|NCT01675427|182845323|SUPERIORITY_OR_OTHER|||||||0.1717|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1717
91486319|NCT01675427|182845323|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0253
91486320|NCT01675427|182845324|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91486321|NCT01675427|182845324|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0330
91486322|NCT01675427|182845324|SUPERIORITY_OR_OTHER|||||||0.1595|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1595
91486323|NCT01675427|182845324|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0412
91486324|NCT01675427|182845325|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
91486325|NCT01675427|182845325|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0421
91486326|NCT01675427|182845325|SUPERIORITY_OR_OTHER|||||||0.7658|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7658
91486327|NCT01675427|182845325|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.2950
91486328|NCT01675427|182845326|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
91486329|NCT01675427|182845326|SUPERIORITY_OR_OTHER|||||||0.0827|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0827
91642579|NCT04035694|183177123|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-2.24|STANDARD_ERROR_OF_MEAN|4.45||0.64|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.64
91642580|NCT04035694|183177124|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.46|STANDARD_ERROR_OF_MEAN|2.53||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
91642581|NCT04035694|183177125|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|2.68||0.65|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.65
91642582|NCT04035694|183177126|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||<.01
91692203|NCT03296527|183279369|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value is based on van Elteren test adjusted for AMH group.||Total gonadotropin dose||||<.001
91675993|NCT02944383|183246436|SUPERIORITY|||||||0.2284||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2284
91675994|NCT02944383|183246436|SUPERIORITY|||||||0.0213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0213
91675995|NCT02944383|183246436|SUPERIORITY|||||||0.033||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0330
91675996|NCT02944383|183246436|SUPERIORITY|||||||0.0221||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0221
91675997|NCT02944383|183246437|SUPERIORITY||Median Difference (Net)|-2.67||||0.2632|TWO_SIDED|95.0|-10.17|5.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||5.67|-10.17|0.2632
91675998|NCT02944383|183246437|SUPERIORITY||Median Difference (Net)|2.02||||0.5382|TWO_SIDED|95.0|-6.77|9.71||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||9.71|-6.77|0.5382
91675999|NCT02944383|183246437|SUPERIORITY||Median Difference (Net)|0.0||||0.1727|TWO_SIDED|95.0|-0.51|1.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||1.01|-0.51|0.1727
91676000|NCT02944383|183246437|SUPERIORITY||Median Difference (Net)|0.0||||0.4567|TWO_SIDED|95.0|-0.51|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||0.51|-0.51|0.4567
91676001|NCT02944383|183246437|SUPERIORITY||Median Difference (Net)|0.0||||0.6142|TWO_SIDED|95.0|-1.21|1.47||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.47|-1.21|0.6142
91676002|NCT02944383|183246437|SUPERIORITY||Median Difference (Net)|-0.02||||0.2409|TWO_SIDED|95.0|-2.23|1.29||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.29|-2.23|0.2409
91486330|NCT01675427|182845326|SUPERIORITY_OR_OTHER|||||||0.7817|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7817
91486331|NCT01675427|182845326|SUPERIORITY_OR_OTHER|||||||0.1986|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.1986
91486332|NCT01675427|182845327|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91486333|NCT01675427|182845327|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0002
91486334|NCT01675427|182845327|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0394
91486335|NCT01675427|182845327|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0493
91486336|NCT01675427|182845328|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
91676003|NCT02944383|183246438|SUPERIORITY|||||||0.2721||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.2721
91676004|NCT02944383|183246438|SUPERIORITY|||||||0.5669||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.5669
91676005|NCT02944383|183246438|SUPERIORITY|||||||0.1686||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.1686
91676006|NCT02944383|183246438|SUPERIORITY|||||||0.4308||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.4308
91676007|NCT02944383|183246438|SUPERIORITY|||||||0.5495||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.5495
91642583|NCT04035694|183177127|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.20
91676008|NCT02944383|183246438|SUPERIORITY|||||||0.2384||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.2384
91676009|NCT02944383|183246439|SUPERIORITY||Median Difference (Net)|-13.99||||0.0781|TWO_SIDED|95.0|-33.76|2.55||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||2.55|-33.76|0.0781
91676010|NCT02944383|183246439|SUPERIORITY||Median Difference (Net)|-2.1||||0.9901|TWO_SIDED|95.0|-19.36|19.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||19.01|-19.36|0.9901
91676011|NCT02944383|183246439|SUPERIORITY||Median Difference (Net)|-25.23||||0.0717|TWO_SIDED|95.0|-43.62|-5.1||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||-5.10|-43.62|0.0717
91676012|NCT02944383|183246439|SUPERIORITY||Median Difference (Net)|-16.09||||0.1548|TWO_SIDED|95.0|-36.78|3.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||3.76|-36.78|0.1548
91642584|NCT04035694|183177128|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.22||0.28|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.28
91642585|NCT04035694|183177129|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|2.77||0.58|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.58
91676013|NCT02944383|183246439|SUPERIORITY||Median Difference (Net)|-47.16||||0.0428|TWO_SIDED|95.0|-119.58|-5.78||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||-5.78|-119.58|0.0428
91676014|NCT02944383|183246439|SUPERIORITY||Median Difference (Net)|-26.13||||0.1836|TWO_SIDED|95.0|-121.44|19.48||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||19.48|-121.44|0.1836
91676015|NCT02944383|183246440|SUPERIORITY|||||||0.1251||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.1251
91676016|NCT02944383|183246440|SUPERIORITY|||||||0.9047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.9047
91692204|NCT03296527|183279371|SUPERIORITY|Treatment groups were compared using the van Elteren test.||||||0.001|||||||van Elteren|p-value is based on van Elteren test adjusted for AMH group.||Number of stimulation days||||0.001
91692205|NCT01597973|183279399|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
91692206|NCT01597973|183279400|SUPERIORITY|||||||0.583|||||||Chi-squared|||||||0.5830
91692207|NCT01597973|183279401|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
91692208|NCT01597973|183279402|SUPERIORITY|||||||0.255|||||||Chi-squared|||||||0.255
91486337|NCT01675427|182845328|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0196
91486338|NCT01675427|182845328|SUPERIORITY_OR_OTHER|||||||0.3268|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.3268
91692209|NCT01597973|183279403|SUPERIORITY|||||||0.59|||||||Chi-squared|||nephrotoxicity analysis||||0.59
91692210|NCT01597973|183279403|SUPERIORITY|||||||0.22|||||||Fisher Exact|||Hypersensitivity analysis||||0.22
91692211|NCT01597973|183279403|SUPERIORITY|||||||0.94|||||||Chi-squared|||Hepatoxicity analysis||||0.94
91642586|NCT04035694|183177130|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.49|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.49
91486339|NCT01675427|182845328|SUPERIORITY_OR_OTHER|||||||0.1667|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1667
91642587|NCT04035694|183177131|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.14||0.55|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.55
91642588|NCT04035694|183177132|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
91642589|NCT04035694|183177133|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
91642590|NCT04035694|183177134|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.15||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
91642591|NCT04035694|183177135|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|3.84||0.75|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.75
91642592|NCT04035694|183177136|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
91642593|NCT04035694|183177137|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
91676017|NCT02944383|183246440|SUPERIORITY|||||||0.0788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.0788
91676018|NCT02944383|183246440|SUPERIORITY|||||||0.1222||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.1222
91486340|NCT01675427|182845329|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0021
91486341|NCT01675427|182845329|SUPERIORITY_OR_OTHER|||||||0.5319|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.5319
91676019|NCT02944383|183246440|SUPERIORITY|||||||0.0734||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.0734
91692212|NCT01597973|183279403|SUPERIORITY|||||||1|||||||Fisher Exact|||Seizures analysis||||1.00
91692213|NCT01597973|183279403|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Neurotoxicity analysis||||0.20
91486342|NCT01675427|182845329|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.0114
91642594|NCT04035694|183177138|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
91642595|NCT04035694|183177139|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.02
91676020|NCT02944383|183246440|SUPERIORITY|||||||0.421||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.4210
91676021|NCT02944383|183246441|SUPERIORITY||Median Difference (Net)|0.43||||0.9672|TWO_SIDED|95.0|-8.12|9.07||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||9.07|-8.12|0.9672
91676022|NCT02944383|183246441|SUPERIORITY||Median Difference (Net)|1.58||||0.7993|TWO_SIDED|95.0|-5.31|8.69||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||8.69|-5.31|0.7993
91676023|NCT02944383|183246442|SUPERIORITY|||||||0.8602||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8602
91676024|NCT02944383|183246442|SUPERIORITY|||||||0.8555||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8555
91676025|NCT02944383|183246443|SUPERIORITY|||||||0.0583||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0583
91486343|NCT01675427|182845329|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2293
91676026|NCT02944383|183246443|SUPERIORITY|||||||0.2289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2289
91676027|NCT02944383|183246443|SUPERIORITY|||||||0.0416||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0416
91692214|NCT03655405|183279431|SUPERIORITY||Incidence Rate Ratio|0.972||||0.723|TWO_SIDED|95.0|0.83|1.138|||Regression, Poisson|Number of PIMs at follow-up, adjusted for baseline value||||1.138|0.830|0.723
91486344|NCT01675427|182845329|SUPERIORITY_OR_OTHER|||||||0.2857|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2857
91692215|NCT03655405|183279432|SUPERIORITY||Incidence Rate Ratio|0.763||||0.033|TWO_SIDED|95.0|0.594|0.979|||Regression, Poisson|Number of potentially inappropriate DDD at follow-up, adjusted for baseline value||||0.979|0.594|0.033
91692216|NCT03655405|183279433|SUPERIORITY||Incidence Rate Ratio|0.915||||0.064|TWO_SIDED|95.0|0.834|1.005|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.005|0.834|0.064
91692217|NCT03655405|183279434|SUPERIORITY||Incidence Rate Ratio|1.019||||0.857|TWO_SIDED|95.0|0.833|1.246|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.246|0.833|0.857
91692218|NCT03655405|183279436|SUPERIORITY||Slope|-1.36||||0.769|TWO_SIDED|95.0|-10.6|7.89|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the scale component||7.89|-10.60|0.769
91692219|NCT03655405|183279436|SUPERIORITY||Slope|-0.096||||0.075|TWO_SIDED|95.0|-0.202|0.01|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the index component||0.01|-0.202|0.075
91486345|NCT01675427|182845329|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0001
91486346|NCT01675427|182845330|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0081
91676028|NCT02944383|183246443|SUPERIORITY|||||||0.015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0150
91676029|NCT02944383|183246443|SUPERIORITY||Median Difference (Net)|-26.21||||0.0718|TWO_SIDED|95.0|-54.29|-1.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.26|-54.29|0.0718
91676030|NCT02944383|183246443|SUPERIORITY||Median Difference (Net)|-18.68||||0.1248|TWO_SIDED|95.0|-50.0|7.31||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.31|-50.00|0.1248
91676031|NCT02944383|183246444|SUPERIORITY|||||||0.2397||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2397
91676032|NCT02944383|183246444|SUPERIORITY|||||||0.5399||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5399
91676033|NCT02944383|183246444|SUPERIORITY|||||||0.0409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0409
91676034|NCT02944383|183246444|SUPERIORITY|||||||0.0073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0073
91676035|NCT02944383|183246444|SUPERIORITY|||||||0.0976||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0976
91676036|NCT02944383|183246444|SUPERIORITY|||||||0.1899||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1899
91676037|NCT02944383|183246445|SUPERIORITY|||||||0.1747||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1747
91676038|NCT02944383|183246445|SUPERIORITY|||||||0.4576||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4576
91676039|NCT02944383|183246445|SUPERIORITY|||||||0.1549||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1549
91676040|NCT02944383|183246445|SUPERIORITY|||||||0.2427||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2427
91676041|NCT02944383|183246445|SUPERIORITY||Median Difference (Net)|1.51||||0.1379|TWO_SIDED|95.0|-6.26|8.73||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||8.73|-6.26|0.1379
91676042|NCT02944383|183246445|SUPERIORITY||Median Difference (Net)|-6.02||||0.249|TWO_SIDED|95.0|-13.1|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.51|-13.10|0.2490
91676043|NCT02944383|183246446|SUPERIORITY|||||||0.155||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1550
91676044|NCT02944383|183246446|SUPERIORITY|||||||0.6604||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6604
91676045|NCT02944383|183246446|SUPERIORITY|||||||0.0952||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0952
91486347|NCT01675427|182845330|SUPERIORITY_OR_OTHER|||||||0.0563|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.0563
91486348|NCT01675427|182845330|SUPERIORITY_OR_OTHER|||||||0.3516|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3516
91486349|NCT01675427|182845330|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.0064
91486350|NCT01675427|182845330|SUPERIORITY_OR_OTHER|||||||0.2707|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2707
91642596|NCT04035694|183177140|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
91676046|NCT02944383|183246446|SUPERIORITY|||||||0.3006||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3006
91676047|NCT02944383|183246446|SUPERIORITY|||||||0.0642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0642
91676048|NCT02944383|183246446|SUPERIORITY|||||||0.3185||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3185
91676049|NCT02944383|183246447|SUPERIORITY|||||||0.0679||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0679
91676050|NCT02944383|183246447|SUPERIORITY|||||||0.4126||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4126
91676051|NCT02944383|183246447|SUPERIORITY|||||||0.0095||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0095
91676052|NCT02944383|183246447|SUPERIORITY|||||||0.0172||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0172
91676053|NCT02944383|183246447|SUPERIORITY||Median Difference (Net)|-23.23||||0.0359|TWO_SIDED|95.0|-41.54|-3.64||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-3.64|-41.54|0.0359
91676054|NCT02944383|183246447|SUPERIORITY||Median Difference (Net)|-16.06||||0.0812|TWO_SIDED|95.0|-38.62|5.61||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.61|-38.62|0.0812
91676055|NCT02944383|183246448|SUPERIORITY|||||||0.1362||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1362
91676056|NCT02944383|183246448|SUPERIORITY|||||||0.6458||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6458
91676057|NCT02944383|183246448|SUPERIORITY|||||||0.0209||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0209
91676058|NCT02944383|183246448|SUPERIORITY|||||||0.0822||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0822
91676059|NCT02944383|183246448|SUPERIORITY|||||||0.0504||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0504
91676060|NCT02944383|183246448|SUPERIORITY|||||||0.1315||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1315
91676061|NCT02944383|183246449|SUPERIORITY|||||||0.0843||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0843
91642597|NCT04035694|183177141|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.57|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.57
91642598|NCT04035694|183177142|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.91|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.91
91642599|NCT04035694|183177143|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.72|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.72
91642600|NCT04035694|183177144|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.07
91642601|NCT04035694|183177145|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
91642602|NCT04035694|183177146|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.17
91642603|NCT04035694|183177147|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
91642604|NCT04035694|183177148|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.08||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
91642605|NCT04035694|183177149|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
91676062|NCT02944383|183246449|SUPERIORITY|||||||0.3587||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3587
91676063|NCT02944383|183246449|SUPERIORITY||Median Difference (Net)|12.99||||0.0843|TWO_SIDED|95.0|-0.54|25.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.51|-0.54|0.0843
91692220|NCT03655405|183279437|SUPERIORITY||Incidence Rate Ratio|1.237||||0.212|TWO_SIDED|95.0|0.886|1.727|||Mixed-effect regression, Poisson|Number at follow-up, adjusted for baseline value||||1.727|0.886|0.212
91486351|NCT01675427|182845330|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||< 0.0001
91486352|NCT01675427|182845331|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0634
91676064|NCT02944383|183246449|SUPERIORITY||Median Difference (Net)|7.98||||0.3587|TWO_SIDED|95.0|-3.7|21.39||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||21.39|-3.70|0.3587
91676065|NCT02944383|183246450|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0768
91676066|NCT02944383|183246450|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4346
91676067|NCT02944383|183246450|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0768
91676068|NCT02944383|183246450|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4346
91676069|NCT02944383|183246451|SUPERIORITY|||||||0.5411||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5411
91676070|NCT02944383|183246451|SUPERIORITY|||||||0.2574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2574
91676071|NCT02944383|183246451|SUPERIORITY||Median Difference (Net)|3.11||||0.5411|TWO_SIDED|95.0|-9.59|14.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.86|-9.59|0.5411
91676072|NCT02944383|183246451|SUPERIORITY||Median Difference (Net)|-7.31||||0.2574|TWO_SIDED|95.0|-19.3|5.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.76|-19.30|0.2574
91676073|NCT02944383|183246452|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3998
91676074|NCT02944383|183246452|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3659
91692221|NCT03655405|183279438|SUPERIORITY||p-value|0.675||||0.675|TWO_SIDED||||||Fisher Exact|||||||0.675
91692222|NCT03655405|183279439|SUPERIORITY||p-value|0.615||||0.615|TWO_SIDED||||||Fisher Exact|||||||0.615
91486353|NCT01675427|182845331|SUPERIORITY_OR_OTHER|||||||0.7176|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.7176
91486354|NCT01675427|182845331|SUPERIORITY_OR_OTHER|||||||0.3944|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3944
91692223|NCT03655405|183279440|SUPERIORITY||p-value|0.366||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.366
91692224|NCT03655405|183279441|SUPERIORITY||p-value|0.738||||0.738|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.738
91692225|NCT03655405|183279442|SUPERIORITY||p-value|0.781||||0.781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.781
91486355|NCT01675427|182845331|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.8610
91486356|NCT01675427|182845331|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4543
91486357|NCT01675427|182845331|SUPERIORITY_OR_OTHER|||||||0.0406|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0406
91486358|NCT01675427|182845332|SUPERIORITY_OR_OTHER|||||||0.8234|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.8234
91486359|NCT01675427|182845332|SUPERIORITY_OR_OTHER|||||||0.2427|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.2427
91486360|NCT01675427|182845332|SUPERIORITY_OR_OTHER|||||||0.4805|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.4805
91486361|NCT01675427|182845332|SUPERIORITY_OR_OTHER|||||||0.2901|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2901
91642606|NCT04035694|183177150|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
91486362|NCT01675427|182845332|SUPERIORITY_OR_OTHER|||||||0.3927|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.3927
91486363|NCT01675427|182845332|SUPERIORITY_OR_OTHER|||||||0.5769|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.5769
91642607|NCT04035694|183177151|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.34
91642608|NCT01102972|183177152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) for the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 24 was -12% or greater.|Treatment difference of proportions|0.33||||0.937||95.0|-7.97|8.64||The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.|Cochran-Mantel-Haenszel||95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.|||8.64|-7.97|0.937
91642609|NCT00318409|183177195|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.98
91642610|NCT01360021|183177278|SUPERIORITY_OR_OTHER||Estimated Geometic Mean Ratio|1.1||||0.001|TWO_SIDED|95.0|1.06|1.14|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid|The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1||1.14|1.06|0.001
91642611|NCT01360021|183177278|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.97|1.05|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.||1.05|0.97|
91642612|NCT01360021|183177279|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.99|1.08|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.||1.08|0.99|
91676075|NCT02944383|183246452|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3998
91676076|NCT02944383|183246452|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3659
91676077|NCT02944383|183246453|SUPERIORITY|||||||0.8823||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8823
91676078|NCT02944383|183246453|SUPERIORITY|||||||0.3788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3788
91676079|NCT02944383|183246453|SUPERIORITY|||||||0.1091||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1091
91676080|NCT02944383|183246453|SUPERIORITY|||||||0.6867||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6867
91486364|NCT04066647|182845346|SUPERIORITY||Mean Difference (Final Values)|0.93928821||||0.9|TWO_SIDED||||||t-test, 2 sided|2 tailed, unpaired t test with Bonferroni correction||||||0.9
91486365|NCT01914757|182845350|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.002|TWO_SIDED|95.0|0.49|0.85|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.85|0.49|0.002
91676081|NCT02944383|183246453|SUPERIORITY||Median Difference (Net)|9.07||||0.3156|TWO_SIDED|95.0|-12.22|36.34||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||36.34|-12.22|0.3156
91676082|NCT02944383|183246453|SUPERIORITY||Median Difference (Net)|-0.3||||0.9734|TWO_SIDED|95.0|-24.58|25.43||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.43|-24.58|0.9734
91676083|NCT02944383|183246454|SUPERIORITY|||||||0.9772||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9772
91676084|NCT02944383|183246454|SUPERIORITY|||||||0.5213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5213
91676085|NCT02944383|183246454|SUPERIORITY|||||||0.1582||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1582
91676086|NCT02944383|183246454|SUPERIORITY|||||||0.4588||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4588
91676087|NCT02944383|183246454|SUPERIORITY|||||||0.4264||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4264
91676088|NCT02944383|183246454|SUPERIORITY|||||||0.8107||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.8107
91676089|NCT02944383|183246455|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0093|TWO_SIDED|95.0|1.51|19.08||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||19.08|1.51|0.0093
91676090|NCT02944383|183246455|SUPERIORITY||Odds Ratio (OR)|2.57||||0.107|TWO_SIDED|95.0|0.82|8.07||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||8.07|0.82|0.1070
91676091|NCT02944383|183246455|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0865|TWO_SIDED|95.0|0.87|7.53||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic|||Week 12||7.53|0.87|0.0865
91676092|NCT02944383|183246455|SUPERIORITY||Odds Ratio (OR)|1.57||||0.399|TWO_SIDED|95.0|0.55|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 12||4.48|0.55|0.3990
91676093|NCT02944383|183246455|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0772|TWO_SIDED|95.0|0.9|8.42||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||8.42|0.90|0.0772
91526662|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.01|TWO_SIDED|95.0|1.19|2.95|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having used Backloaded Syringe in the past 30 days|Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviors||2.95|1.19|<0.01
91692226|NCT03655405|183279443|SUPERIORITY||p-value|0.958||||0.958|TWO_SIDED||||||Fisher Exact|||||||0.958
91692227|NCT03655405|183279444|SUPERIORITY||p-value|0.911||||0.911|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.911
91692228|NCT01624740|183279463|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|Period effect p=0.11||||||0.74
91692229|NCT00529087|183279526|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|24.4|||<|0.001||95.0|17.3|31.4|||Chi-squared|||||31.4|17.3|<0.001
91692230|NCT00529087|183279527|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.5|||<|0.001||95.0|15.1|24.0|||t-test, 2 sided|||||24.0|15.1|<0.001
91692231|NCT00529087|183279527|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.9|||<|0.001||95.0|16.1|25.7|||t-test, 2 sided|||||25.7|16.1|<0.001
91526663|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.13|TWO_SIDED|95.0|0.83|2.1|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|"Adjusted odds for travel in prior 3 months as a risk factor for having done Someone's rinse in the past 30 days"|Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 days||2.10|0.83|0.13
91486366|NCT01914757|182845350|SUPERIORITY_OR_OTHER||Rate Ratio|0.72||||0.019|TWO_SIDED|95.0|0.54|0.95|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.95|0.54|0.019
91486367|NCT01914757|182845351|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.92|0.45|0.015
91486368|NCT01914757|182845351|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.005|TWO_SIDED|95.0|0.42|0.86|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.86|0.42|0.005
91486369|NCT01914757|182845352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.005|TWO_SIDED|95.0|0.037|0.213|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.213|0.037|0.005
91692232|NCT00529087|183279528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|Log-rank test for comparisons of survival distributions||||||<0.001
91692233|NCT00529087|183279529|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.6|||<|0.001||95.0|1.1|2.1|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||2.1|1.1|<0.001
91692234|NCT00529087|183279529|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.7||||0.011||95.0|0.2|1.2|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||1.2|0.2|0.011
91692235|NCT00529087|183279531|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.4|||<|0.001||95.0|9.5|31.3|||Chi-squared|||||31.3|9.5|<0.001
91692236|NCT00529087|183279531|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|7.0||||0.212||95.0|-4.0|18.0|||Chi-squared|||||18.0|-4.0|0.212
91692237|NCT00529087|183279532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
91692238|NCT00529087|183279532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
91692239|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.5|||<|0.001||95.0|11.2|17.9|||ANOVA|Treatment as a factor||1 hour||17.9|11.2|<0.001
91692240|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.001||95.0|4.6|11.4|||ANOVA|Treatment as a factor||1 hour||11.4|4.6|<0.001
91692241|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.5|||<|0.001||95.0|14.4|22.5|||ANOVA|Treatment as a factor||2 hours||22.5|14.4|<0.001
91692242|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.4|||<|0.001||95.0|6.3|14.5|||ANOVA|Treatment as a factor||2 hours||14.5|6.3|<0.001
91692243|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|||<|0.001||95.0|15.0|23.5|||ANOVA|Treatment as a factor||3 hours||23.5|15.0|<0.001
91692244|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.7|15.3|||ANOVA|Treatment as a factor||3 hours||15.3|6.7|<0.001
91692245|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.5|||<|0.001||95.0|15.2|23.9|||ANOVA|Treatment as a factor||4 hours||23.9|15.2|<0.001
91692246|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.6|15.4|||ANOVA|Treatment as a factor||4 hours||15.4|6.6|<0.001
91692247|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.7|||<|0.001||95.0|15.2|24.1|||ANOVA|Treatment as a factor||6 hours||24.1|15.2|<0.001
91692248|NCT00529087|183279533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||<|0.001||95.0|6.2|15.2|||ANOVA|Treatment as a factor||6 hours||15.2|6.2|<0.001
91692249|NCT00529087|183279534|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|21.0|||<|0.001||95.0|10.2|31.9|||Chi-squared|||||31.9|10.2|<0.001
91692250|NCT00529087|183279534|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.316||95.0|-5.3|16.5|||Chi-squared|||||16.5|-5.3|0.316
91692251|NCT00529087|183279535|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.7|||<|0.001||95.0|9.4|30.1|||Chi-squared|||||30.1|9.4|<0.001
91692252|NCT00529087|183279535|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|13.3||||0.016||95.0|2.6|24.0|||Chi-squared|||||24.0|2.6|0.016
91692253|NCT00529087|183279536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||<|0.001||95.0|1.0|1.9|||ANCOVA|Treatment as factor, Baseline as covariate||||1.9|1.0|<0.001
91692254|NCT00529087|183279536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.102||95.0|-0.1|0.8|||ANCOVA|Treatment as factor, Baseline as covariate||||0.8|-0.1|0.102
91692255|NCT00529087|183279537|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|||<|0.001||95.0|0.6|1.5|||ANCOVA|||||1.5|0.6|<0.001
91692256|NCT00529087|183279537|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|||<|0.001||95.0|0.0|0.9|||ANCOVA|||||0.9|0.0|<0.001
91692257|NCT00529087|183279538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|||<|0.001||95.0|0.8|1.6|||ANCOVA|Treatment as factor, Baseline as covariate||||1.6|0.8|<0.001
91692258|NCT00529087|183279538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.012||95.0|0.1|0.9|||ANCOVA|Treatment as factor, Baseline as covariate||||0.9|0.1|0.012
91642613|NCT01360021|183177280|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|6.75||0.825|TWO_SIDED|95.0|-11.81|14.8|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid||14.80|-11.81|0.825
91642614|NCT01360021|183177280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.52|STANDARD_ERROR_OF_MEAN|6.8||0.001|TWO_SIDED|95.0|20.11|46.93|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid||46.93|20.11|0.001
91642615|NCT01360021|183177280|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|6.15||0.81|TWO_SIDED|95.0|-10.66|13.61|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||13.61|-10.66|0.810
91642616|NCT01360021|183177280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.25|STANDARD_ERROR_OF_MEAN|6.21||0.001|TWO_SIDED|95.0|20.01|44.49|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.||44.49|20.01|0.001
91642617|NCT01360021|183177281|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.272|TWO_SIDED|95.0|-0.1|0.35|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||0.35|-0.10|0.272
91642618|NCT01360021|183177282|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.69||0.025|TWO_SIDED|95.0|-11.41|-0.79|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||-0.79|-11.41|0.025
91642619|NCT01360021|183177283|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.23||0.258|TWO_SIDED|95.0|-0.19|0.71|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.||0.71|-0.19|0.258
91642620|NCT00650806|183177292|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.031|TWO_SIDED|95.0|-1.6|-0.1|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.1|-1.6|0.031
91642621|NCT00650806|183177292|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.8|-2.4|<0.001
91642622|NCT00650806|183177292|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.6|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.6|-2.1|<0.001
91642623|NCT00650806|183177293|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.4||0.045|TWO_SIDED|95.0|-1.58|-0.02|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.02|-1.58|0.045
91642624|NCT00650806|183177293|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.80|-2.40|<0.001
91642625|NCT00650806|183177293|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.07|-0.51|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.51|-2.07|0.001
91642626|NCT00650806|183177294|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.031|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.03|-0.59|0.031
91642627|NCT00650806|183177294|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.32|-0.90|<0.001
91642628|NCT00650806|183177294|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.20|-0.76|<0.001
91692259|NCT00529087|183279539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.002||95.0|0.2|0.7|||ANCOVA|Treatment as factor, Baseline as covariate||||0.7|0.2|0.002
91676094|NCT02944383|183246455|SUPERIORITY||Odds Ratio (OR)|1.54||||0.4315|TWO_SIDED|95.0|0.53|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||4.48|0.53|0.4315
91676095|NCT03623386|183246522|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
91676096|NCT03623386|183246523|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
91676097|NCT03623386|183246524|SUPERIORITY||||||>|0.05|||||||ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||>0.05
91676098|NCT03623386|183246525|SUPERIORITY|||||||0.026||||||p value reflects the effect of time.|ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||0.026
91676099|NCT05855616|183246541|OTHER||Odds Ratio (OR)|0.533||||1|TWO_SIDED|95.0|0.048|5.892|||t-test, 1 sided|||||5.892|0.048|1.00
91676100|NCT05855616|183246542|OTHER||Odds Ratio (OR)|0.176||||0.013|TWO_SIDED|95.0|0.039|0.79|||t-test, 1 sided|||||0.790|0.039|0.013
91676101|NCT05855616|183246544|OTHER|||||||0.137|||||||Chi-squared, Corrected|||||||0.137
91676102|NCT05855616|183246545|OTHER|||||||0.764|||||||Chi-squared, Corrected|||||||0.764
91642629|NCT00650806|183177295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.317||95.0|0.6|5.6||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||5.6|0.6|0.317
91676103|NCT05855616|183246546|OTHER|||||||0.055|||||||Chi-squared, Corrected|||||||0.055
91676104|NCT01388166|183246547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91676105|NCT01388166|183246548|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91676106|NCT01388166|183246549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91642630|NCT00650806|183177295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.059|TWO_SIDED|95.0|0.9|11.1||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||11.1|0.9|0.059
91676107|NCT01429051|183246571|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.002|TWO_SIDED|95.0|0.41|1.179|||Mixed Models Analysis|A mixed effects model with episode baseline PI as a covariate, treatment as a fixed effect and patient as a random effect.||||1.179|0.41|0.002
91642631|NCT00650806|183177295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.027|TWO_SIDED|95.0|1.0|10.0||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||10.0|1.0|0.027
91642632|NCT00650806|183177296|SUPERIORITY_OR_OTHER|||||||0.117|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.117
91642633|NCT00650806|183177296|SUPERIORITY_OR_OTHER|||||||0.225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.225
91642634|NCT00650806|183177296|SUPERIORITY_OR_OTHER|||||||0.317|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.317
91642635|NCT00650806|183177297|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.23||0.835|TWO_SIDED|95.0|-2.68|2.17|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||2.17|-2.68|0.835
91642636|NCT00650806|183177297|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|1.29||0.466|TWO_SIDED|95.0|-3.47|1.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.59|-3.47|0.466
91642637|NCT00650806|183177297|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.25||0.273|TWO_SIDED|95.0|-3.87|1.09|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.09|-3.87|0.273
91676108|NCT00986180|183246641|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|16.02||0.9703|TWO_SIDED|95.0|-32.1|30.9|||ANCOVA|||||30.9|-32.1|0.9703
91676109|NCT00986180|183246642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|6.08||0.7691|TWO_SIDED|95.0|-10.1|13.7|||ANCOVA|||||13.7|-10.1|0.7691
91676110|NCT00986180|183246643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|9.24||0.9282|TWO_SIDED|95.0|-17.3|19.0|||ANCOVA|||||19.0|-17.3|0.9282
91676111|NCT00986180|183246644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|29.75||0.9562|TWO_SIDED|95.0|-60.1|56.8|||ANCOVA|||||56.8|-60.1|0.9562
91676112|NCT00986180|183246645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|6.08||0.7973|TWO_SIDED|95.0|-13.5|10.4|||ANCOVA|||||10.4|-13.5|0.7973
91676113|NCT00986180|183246646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|9.3||0.7882|TWO_SIDED|95.0|-20.8|15.8|||ANCOVA|||||15.8|-20.8|0.7882
91676114|NCT00986180|183246647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|15.82||0.7491|TWO_SIDED|95.0|-36.1|26.0|||ANCOVA|||||26.0|-36.1|0.7491
91676115|NCT00986180|183246648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|29.03||0.6897|TWO_SIDED|95.0|-68.6|45.4|||ANCOVA|||||45.4|-68.6|0.6897
91676116|NCT00986180|183246649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|7.02||0.8226|TWO_SIDED|95.0|-12.2|15.4|||ANCOVA|||||15.4|-12.2|0.8226
91676117|NCT00986180|183246650|SUPERIORITY_OR_OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.8880
91676118|NCT00986180|183246651|SUPERIORITY_OR_OTHER|||||||0.4115|||||||Wilcoxon (Mann-Whitney)|||||||0.4115
91676119|NCT00986180|183246652|SUPERIORITY_OR_OTHER|||||||0.8495|||||||Wilcoxon (Mann-Whitney)|||||||0.8495
91676120|NCT00986180|183246653|SUPERIORITY_OR_OTHER|||||||0.7846|||||||Wilcoxon (Mann-Whitney)|||||||0.7846
91676121|NCT00986180|183246654|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.4790
91676122|NCT00986180|183246655|SUPERIORITY_OR_OTHER|||||||0.3147|||||||Wilcoxon (Mann-Whitney)|||||||0.3147
91676123|NCT00986180|183246656|SUPERIORITY_OR_OTHER|||||||0.5411|||||||Wilcoxon (Mann-Whitney)|||||||0.5411
91676124|NCT00986180|183246657|SUPERIORITY_OR_OTHER|||||||0.6137|||||||Wilcoxon (Mann-Whitney)|||||||0.6137
91676125|NCT00986180|183246658|SUPERIORITY_OR_OTHER|||||||0.7246|||||||Wilcoxon (Mann-Whitney)|||||||0.7246
91676126|NCT00986180|183246659|SUPERIORITY_OR_OTHER|||||||0.4882|||||||Wilcoxon (Mann-Whitney)|||||||0.4882
91717038|NCT02360488|183326459|NON_INFERIORITY|The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.|Mean Difference (Net)|0.06||||0.96|TWO_SIDED|95.0|-2.14|2.26|||Regression, Linear|The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.||||2.26|-2.14|.96
91717039|NCT01687218|183326476|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.88|TWO_SIDED|95.0|0.73|1.44|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.44|0.73|0.88
91717040|NCT01687218|183326476|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.43|TWO_SIDED|95.0|0.64|1.21|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.21|0.64|0.43
91717041|NCT01687218|183326477|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.15|0.5|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.50|0.15|<0.0001
91717042|NCT01687218|183326477|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37||||0.002|TWO_SIDED|95.0|0.2|0.7|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.70|0.20|0.002
91717043|NCT01687218|183326478|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.29|1.08|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.08|0.29|0.08
91486370|NCT01914757|182845352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.01|TWO_SIDED|95.0|0.028|0.204|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.204|0.028|0.01
91486371|NCT01914757|182845353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.268|TWO_SIDED|95.0|-0.049|0.176|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.176|-0.049|0.268
91486372|NCT01914757|182845353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.786|TWO_SIDED|95.0|-0.127|0.096|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.096|-0.127|0.786
91486373|NCT01914757|182845354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.224|TWO_SIDED|95.0|-0.32|0.07|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.07|-0.32|0.224
91486374|NCT01914757|182845354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.019|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||-0.04|-0.43|0.019
91676127|NCT00986180|183246660|SUPERIORITY_OR_OTHER|||||||0.7201|||||||Cochran-Mantel-Haenszel|||||||0.7201
91676128|NCT00986180|183246662|SUPERIORITY_OR_OTHER|||||||0.5208|||||||Cochran-Mantel-Haenszel|||||||0.5208
91676129|NCT00986180|183246664|SUPERIORITY_OR_OTHER|||||||0.0401|||||||Cochran-Mantel-Haenszel|||||||0.0401
91676130|NCT00986180|183246666|SUPERIORITY_OR_OTHER|||||||0.4679|||||||Cochran-Mantel-Haenszel|||||||0.4679
91676131|NCT00986180|183246668|SUPERIORITY_OR_OTHER|||||||0.1454|||||||Fisher Exact|||||||0.1454
91676132|NCT00986180|183246669|SUPERIORITY_OR_OTHER|||||||0.1541|||||||Fisher Exact|||||||0.1541
91676133|NCT00986180|183246671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.92|2.06|||Cochran-Mantel-Haenszel|||||2.06|0.92|
91676134|NCT00986180|183246672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|1.17|2.57|||Cochran-Mantel-Haenszel|||||2.57|1.17|
91676135|NCT00986180|183246673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|1.45|8.11|||Cochran-Mantel-Haenszel|||||8.11|1.45|
91676136|NCT00986180|183246674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.67|||Cochran-Mantel-Haenszel|||||1.67|0.54|
91676137|NCT00986180|183246675|SUPERIORITY_OR_OTHER|||||||0.5828|||||||Log Rank|||||||0.5828
91676138|NCT00986180|183246676|SUPERIORITY_OR_OTHER|||||||0.9084|||||||Log Rank|||||||0.9084
91676139|NCT02408068|183246695|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|77.56|||||TWO_SIDED|90.0|70.89|84.86|||ANOVA|||Results obtained using a mixed effects ANOVA with fixed effects for study period, sequence, treatment and subject (sequence) (excl. tmax).||84.86|70.89|
91676140|NCT02408068|183246696|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|108.33|||||TWO_SIDED|90.0|102.3|114.72|||ANOVA|||||114.72|102.30|
91486375|NCT01914757|182845355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.287|TWO_SIDED|95.0|-0.44|0.13|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.13|-0.44|0.287
91486376|NCT01914757|182845355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.966|TWO_SIDED|95.0|-0.28|0.29|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.29|-0.28|0.966
91642638|NCT00650806|183177298|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.149|TWO_SIDED|95.0|-3.85|0.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.59|-3.85|0.149
91676141|NCT02408068|183246697|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.25||||0.0005|TWO_SIDED|95.0|1.25|3.75|||Wilcoxon (Mann-Whitney)|||||3.75|1.25|0.0005
91486377|NCT01914757|182845356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.603|TWO_SIDED|95.0|-0.58|0.99|||Mixed Models Analysis|Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.||||0.99|-0.58|0.603
91486378|NCT01914757|182845356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.209|TWO_SIDED|95.0|-1.29|0.28|||Mixed Models Analysis|Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.||||0.28|-1.29|0.209
91486379|NCT01914757|182845357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86||||0.029|TWO_SIDED|95.0|1.59|30.12|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||30.12|1.59|0.029
91676142|NCT02408068|183246698|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|83.27|||||TWO_SIDED|90.0|75.58|91.74||||||||91.74|75.58|
91676143|NCT02408068|183246699|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|118.83|||||TWO_SIDED|90.0|111.58|126.54||||||||126.54|111.58|
91676144|NCT02408068|183246700|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.5||||0.0014|TWO_SIDED|95.0|2.25|4.38|||Wilcoxon (Mann-Whitney)|||||4.38|2.25|0.0014
91676145|NCT00886288|183246732|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91676146|NCT00472797|183246740|SUPERIORITY_OR_OTHER||mean|2.73|||<|0.001||97.5|2.73|2.73||P-Value denotes percent change from baseline to week 12 for all combined subjects.|t-test, 1 sided|||A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.||2.73|2.73|<0.001
91676147|NCT00472797|183246741|SUPERIORITY_OR_OTHER|||||||0.466||||||P-value denotes difference between treatment groups|ANOVA|||||||0.466
91676148|NCT00472797|183246741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||<0.001
91676149|NCT00472797|183246741|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||0.003
91676150|NCT00472797|183246742|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.|t-test, 1 sided|Paired t-test for change from baseline to week 12||Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response||||<0.001
91676151|NCT00472797|183246742|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.|ANOVA|||Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.||||0.110
91676152|NCT00472797|183246743|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value refers to differneces in total score from baseline to week 12 between treatment groups.|ANOVA|||Analysis evaluates total score from baseline to week 12 for differences between each treatment group.||||0.302
91676153|NCT00472797|183246745|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|ANOVA|||Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.||||0.899
91676154|NCT00472797|183246746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 12||||<0.001
91676155|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 36||||0.234
91676156|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 1||||0.001
91676157|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 3||||0.004
91642639|NCT00650806|183177298|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|1.18||0.541|TWO_SIDED|95.0|-3.05|1.6|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.6|-3.05|0.541
91642640|NCT00650806|183177298|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|1.15||0.121|TWO_SIDED|95.0|-4.03|0.47|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.47|-4.03|0.121
91642641|NCT00650806|183177299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0091||0.239|TWO_SIDED|95.0|-0.0071|0.0286|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0286|-0.0071|0.239
91642642|NCT00650806|183177299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.0095||0.9|TWO_SIDED|95.0|-0.0174|0.0198|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0198|-0.0174|0.900
91642643|NCT00650806|183177299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0092||0.822|TWO_SIDED|95.0|-0.016|0.0202|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0202|-0.0160|0.822
91642644|NCT02242942|183177300|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.22|0.51|||Log Rank||Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.51|0.22|<0.0001
91642645|NCT02242942|183177301|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.23|0.53|||Log Rank||Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.53|0.23|<0.0001
91642646|NCT02242942|183177302|SUPERIORITY||Difference in Response Rates|13.43||||0.0007|TWO_SIDED|95.0|5.47|21.38||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||21.38|5.47|0.0007
91642647|NCT02242942|183177303|SUPERIORITY||Difference in Response Rates|26.39|||<|0.0001|TWO_SIDED|95.0|17.41|35.36||P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||35.36|17.41|<0.0001
91642648|NCT02242942|183177304|SUPERIORITY||Difference in MRD Negative Rates|40.28|||<|0.0001|TWO_SIDED|95.0|31.45|49.1|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||49.10|31.45|<0.0001
91642649|NCT02242942|183177305|SUPERIORITY||Difference in MRD Negative Rates|39.81|||<|0.0001|TWO_SIDED|95.0|31.27|48.36|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||48.36|31.27|<0.0001
91642650|NCT02242942|183177307|SUPERIORITY||Difference in MRD Negative Rates|32.87|||<|0.0001|TWO_SIDED|95.0|23.76|41.98|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||41.98|23.76|<0.0001
91676158|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Exisit Visit LOCF||||0.036
91676159|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 12||||0.002
91486380|NCT01914757|182845357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.27||||0.037|TWO_SIDED|95.0|0.9|29.64|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||29.64|0.9|0.037
91486381|NCT01914757|182845357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.54||||0.018|TWO_SIDED|95.0|3.07|32.0|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||32|3.07|0.018
91642651|NCT02242942|183177308|SUPERIORITY||Difference in MRD Negative Rates|38.43|||<|0.0001|TWO_SIDED|95.0|30.15|46.71|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||46.71|30.15|<0.0001
91642652|NCT02242942|183177309|SUPERIORITY||Difference in Response Rates|1.85||||0.5612|TWO_SIDED|95.0|-4.63|8.33||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||8.33|-4.63|0.5612
91642653|NCT02242942|183177311|SUPERIORITY||Difference in Response Rates|0.93||||0.7169|TWO_SIDED|95.0|-4.66|6.51|||Cochran-Mantel-Haenszel|P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|95% CI for difference in rates were constructed using Anderson-Hauck method.|||6.51|-4.66|0.7169
91642654|NCT05014672|183177323|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.86||||0.0206|TWO_SIDED|95.0|0.746|0.994|||Mixed Model Repeated Measures|||||0.994|0.746|0.0206
91642655|NCT05014672|183177323|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.81||||0.0057|TWO_SIDED|95.0|0.703|0.939|||Mixed Model Repeated Measures|||||0.939|0.703|0.0057
91642656|NCT05014672|183177324|SUPERIORITY||LS mean difference vs placebo|-2.16||||0.2214|TWO_SIDED|95.0|-7.785|3.458|||Mixed Model Repeated Measures|||||3.458|-7.785|0.2214
91676160|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 36||||0.468
91676161|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.602||95.0|||||t-test, 2 sided|Paired||Mental Component - Change from Baseline to Extension Visit 1||||0.602
91676162|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.414||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Extension Visit 3||||0.414
91676163|NCT00472797|183246746|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Exit Visit LOCF||||0.991
91692260|NCT00529087|183279539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.119||95.0|-0.1|0.5|||ANCOVA|Treatment as factor, Baseline as covariate||||0.5|-0.1|0.119
91486382|NCT01914757|182845357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.22||||0.004|TWO_SIDED|95.0|6.65|35.79|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||35.79|6.65|0.004
91676164|NCT00700817|183246748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6||||0.0001||95.0|-0.77|-0.43||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.||-0.43|-0.77|0.0001
91676165|NCT00700817|183246748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.34||||0.0001||95.0|-0.51|-0.16||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.||-0.16|-0.51|0.0001
91676166|NCT00700817|183246749|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.63||||0.0001||95.0|-0.81|-0.44||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.8 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.44|-0.81|0.0001
91676167|NCT00700817|183246749|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.4||||0.0001||95.0|-0.59|-0.22||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.2 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.22|-0.59|0.0001
91676168|NCT00700817|183246751|SUPERIORITY_OR_OTHER||Change within treatment group|-0.24|STANDARD_DEVIATION|0.7||0.006||95.0|-0.41|-0.07||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.07|-0.41|0.0060
91676169|NCT00700817|183246751|SUPERIORITY_OR_OTHER||Change within treatment group|-0.45|STANDARD_DEVIATION|0.9||0.0001||95.0|-0.67|-0.23||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.23|-0.67|0.0001
91676170|NCT01673698|183246876|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||t-test, 1 sided|||||||0.0041
91676171|NCT01673698|183246877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 1 sided|||||||<0.0001
91676172|NCT01673698|183246878|SUPERIORITY_OR_OTHER|||||||0.561|TWO_SIDED||||||Chi-squared|||||||0.5610
91676173|NCT01583218|183246879|SUPERIORITY||Relative Risk Reduction (RRR)|0.209||||0.038|TWO_SIDED|95.0|0.013|0.366|||Cochran-Mantel-Haenszel|||||0.366|0.013|0.038
91676174|NCT01583218|183246880|SUPERIORITY||Relative Risk Reduction (RRR)|0.216||||0.018|TWO_SIDED|95.0|0.041|0.359|||Cochran-Mantel-Haenszel|||||0.359|0.041|0.018
91486383|NCT01914757|182845358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.4|TWO_SIDED|95.0|-0.06|0.03|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.03|-0.06|0.4
91676175|NCT01583218|183246881|SUPERIORITY||Relative Risk Reduction (RRR)|0.254||||0.003|TWO_SIDED|95.0|0.092|0.387|||Cochran-Mantel-Haenszel|||||0.387|0.092|0.003
91676176|NCT01583218|183246882|SUPERIORITY|||||||0.554|||||||Chi-squared|||||||0.554
91676177|NCT01583218|183246883|SUPERIORITY||Relative Risk Reduction (RRR)|0.326||||0.092|TWO_SIDED|95.0|-0.069|0.576|||Cochran-Mantel-Haenszel|||||0.576|-0.069|0.092
91676178|NCT01583218|183246884|SUPERIORITY||Relative Risk Reduction (RRR)|0.295||||0.11|TWO_SIDED|95.0|-0.085|0.542|||Cochran-Mantel-Haenszel|||||0.542|-0.085|0.11
91486384|NCT01914757|182845358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.146|TWO_SIDED|95.0|-0.08|0.01|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.01|-0.08|0.146
91486385|NCT01914757|182845359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.043|TWO_SIDED|95.0|-0.38|-0.01|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.01|-0.38|0.043
91676179|NCT01583218|183246885|SUPERIORITY||Relative Risk Reduction (RRR)|0.358||||0.039|TWO_SIDED|95.0|0.02|0.58|||Cochran-Mantel-Haenszel|||||0.580|0.020|0.039
91676180|NCT03182582|183246979|SUPERIORITY|||||||0.003|||||||Paired t test|||A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.||||0.003
91676181|NCT03334721|183246985|SUPERIORITY|"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term. Analysis used Linear Mixed Modeling with Fixed Factors."|Test III Tests of Fixed Effects (F)|0.141||||0.711|TWO_SIDED|||||Treatment Condition Factor (0 = Placebo, 1 = Gabapentin)|Mixed Models Analysis|df = 1, 20.183|||"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term."|||0.711
91676182|NCT01232491|183246989|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.49||||0.132||95.0|-0.15|1.13||If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference \[dietary intervention versus no dietary intervention\]) was less than 0 then superiority for dietary intervention was considered confirmed.|Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.||1.13|-0.15|0.132
91486386|NCT01914757|182845359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.008|TWO_SIDED|95.0|-0.44|-0.07|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.07|-0.44|0.008
91642657|NCT05014672|183177324|SUPERIORITY||LS mean difference vs placebo|0.63||||0.591|TWO_SIDED|95.0|-4.859|6.12|||Mixed Model Repeated Measures|||||6.120|-4.859|0.5910
91642658|NCT05014672|183177327|SUPERIORITY||LS mean difference vs placebo|0.42||||0.5675|TWO_SIDED|95.0|-4.454|5.285|||Mixed Model Repeated Measures|||||5.285|-4.454|0.5675
91642659|NCT05014672|183177327|SUPERIORITY||LS mean difference vs placebo|0.02||||0.5032|TWO_SIDED|95.0|-4.886|4.926|||Mixed Model Repeated Measures|||||4.926|-4.886|0.5032
91642660|NCT05014672|183177328|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.85||||0.0491|TWO_SIDED|95.0|0.692|1.033|||Mixed Model Repeated Measures|||||1.033|0.692|0.0491
91642661|NCT05014672|183177328|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.95||||0.3099|TWO_SIDED|95.0|0.783|1.158|||Mixed Model Repeated Measures|||||1.158|0.783|0.3099
91642662|NCT05014672|183177334|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.84||||0.0039|TWO_SIDED|95.0|0.743|0.954|||Mixed Model Repeated Measures|||||0.954|0.743|0.0039
91642663|NCT05014672|183177335|SUPERIORITY||LS mean difference vs placebo|0.3905||||0.3905|TWO_SIDED|95.0|-5.496|4.153|||Mixed Model Repeated Measures|||||4.153|-5.496|0.3905
91642664|NCT05014672|183177336|SUPERIORITY||LS mean difference vs placebo|0.21||||0.5393|TWO_SIDED|95.0|-3.968|4.381|||Mixed Model Repeated Measures|||||4.381|-3.968|0.5393
91642665|NCT05014672|183177337|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.9||||0.1079|TWO_SIDED|95.0|0.759|1.065|||Mixed Model Repeated Measures|||||1.065|0.759|0.1079
91642666|NCT00145119|183177348|SUPERIORITY_OR_OTHER_LEGACY||proportion (%)|8.0||||||||||||||||||
91642667|NCT04411641|183177349|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.693||||0.0026|TWO_SIDED|95.0|0.546|0.88||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation.Covariates were treatment group,age at screening (\>40,\<=40 years),geographic region (United States \[US\], non-US),baseline EDSS score \& baseline gadolinium (Gd)-enhancing T1 lesions (presence, absence).In this analysis, for participants who completed study with 3-month confirmation and continued to meet disability progression criteria throughout EOS, their 6-month CDP status was imputed via multiple imputation method.||0.880|0.546|0.0026
91642668|NCT04411641|183177350|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.757||||0.0134|TWO_SIDED|95.0|0.607|0.944||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.944|0.607|0.0134
91642669|NCT04411641|183177351|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Relative Risk|0.622||||0.011|TWO_SIDED|95.0|0.432|0.897||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Derived using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score, and baseline number of T2 lesions as covariates, and log transformed observation duration as the offset variable.||0.897|0.432|0.0110
91486387|NCT01914757|182845360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.078|TWO_SIDED|95.0|-0.51|0.03|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.03|-0.51|0.078
91642670|NCT04411641|183177352|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.972||||0.8428|TWO_SIDED|95.0|0.735|1.286||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||1.286|0.735|0.8428
91642671|NCT04411641|183177353|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.767||||0.004|TWO_SIDED|95.0|0.64|0.919|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.919|0.640|0.0040
91676183|NCT01232491|183246990|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.17||||0.137||95.0|-0.05|0.39|||Regression, Linear|||Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.||0.39|-0.05|0.137
91676184|NCT01232491|183246991|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.13||||0.053||95.0|0.0|0.26|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.||0.26|-0.00|0.053
91486388|NCT01914757|182845360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.16|-0.37|0.449
91486389|NCT01914757|182845361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.69|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.69|0.31|<0.001
91486390|NCT01914757|182845361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.023|TWO_SIDED|95.0|0.45|0.95|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.95|0.45|0.023
91486391|NCT01914757|182845362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.8|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first Exacerbation||0.80|0.46|<0.001
91486392|NCT01914757|182845362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.018|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first asthma exacerbation||0.95|0.55|0.018
91486393|NCT01914757|182845363|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.837|TWO_SIDED|95.0|0.48|1.82|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||1.82|0.48|0.837
91486394|NCT01914757|182845363|SUPERIORITY_OR_OTHER||Rate Ratio|1.23||||0.538|TWO_SIDED|95.0|0.64|2.35|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||2.35|0.64|0.538
91486395|NCT01914757|182845367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.119|TWO_SIDED|95.0|-0.04|0.37|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.37|-0.04|0.119
91486396|NCT01914757|182845367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.019|TWO_SIDED|95.0|0.04|0.45|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.45|0.04|0.019
91486397|NCT00408629|182845374|SUPERIORITY_OR_OTHER|||||||0.019||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.019
91486398|NCT00408629|182845375|SUPERIORITY_OR_OTHER|||||||0.004||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.004
91642672|NCT04411641|183177354|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|1.882||||0.0206|TWO_SIDED|95.0|1.102|3.214|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||3.214|1.102|0.0206
91642673|NCT04411641|183177355|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|LS Mean Difference|0.082||||0.1646|TWO_SIDED|95.0|-0.034|0.197|||Mixed model repeated measures (MMRM)|||Covariates in the mixed-effect model with repeated measures were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), visit, treatment-by-visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.197|-0.034|0.1646
91642674|NCT04342390|183177366|SUPERIORITY|||||||0.363|||||||ANCOVA|||||||0.363
91642675|NCT04342390|183177367|SUPERIORITY|||||||0.633|||||||ANCOVA|||||||0.633
91642676|NCT04342390|183177368|SUPERIORITY|||||||0.433|||||||ANCOVA|||||||0.433
91642677|NCT04342390|183177369|SUPERIORITY|||||||0.822|||||||ANCOVA|||||||0.822
91642678|NCT04342390|183177370|SUPERIORITY|||||||0.554|||||||ANCOVA|||||||0.554
91642679|NCT04342390|183177371|SUPERIORITY|||||||0.186|||||||ANCOVA|||||||0.186
91642680|NCT04342390|183177372|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
91642681|NCT04584294|183177373|SUPERIORITY||Odds Ratio (OR)|1.46||||0.31|TWO_SIDED|95.0|0.7|3.06||The threshold for significance was set at p\<0.05.|Regression, Logistic|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm. Analyses accounted for missing data in outcome and a priori adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).||3.06|0.70|0.31
91642682|NCT04584294|183177373|SUPERIORITY|||||||||||||Threshold for significance was set at p\<0.05.|Regression, Logistic|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R."|P-value and estimated OR (95% CI) is not available because the model did not converge.|||
91676185|NCT01232491|183246992|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.07||||0.674||95.0|-0.25|0.39|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.||0.39|-0.25|0.674
91692261|NCT00529087|183279540|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3||||0.008||95.0|-0.5|-0.1|||ANCOVA|Treatment as factor, Baseline as covariate||||-0.1|-0.5|0.008
91692262|NCT00529087|183279540|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.2||||0.015||95.0|-0.5|0.0|||ANCOVA|Treatment as factor, Baseline as covariate||||0.0|-0.5|0.015
91486399|NCT00408629|182845376|SUPERIORITY_OR_OTHER|||||||0.047||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.047
91486400|NCT00408629|182845377|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
91676186|NCT00856973|183247031|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|7.33|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-5.17|19.83|||ANCOVA|Bonferroni adjustment was use for multiple comparisons|Difference calculated as Eszopiclone minus placebo|This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou||19.83|-5.17|>0.05
91676187|NCT00856973|183247031|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|2.21|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-10.23|14.65|||ANCOVA|||This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.||14.65|-10.23|>0.05
91676188|NCT01196078|183247058|SUPERIORITY_OR_OTHER||Difference in Percentages|13.88||||0.0388|TWO_SIDED|95.0|-0.22|26.19||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group \[ECOG\] status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.|||26.19|-0.22|0.0388
91676189|NCT01196078|183247059|SUPERIORITY_OR_OTHER||Difference in Percentages|14.79||||0.1061|TWO_SIDED|95.0|-3.54|31.33||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.|||31.33|-3.54|0.1061
91676190|NCT01196078|183247060|SUPERIORITY_OR_OTHER|||||||0.9505|||||||Log Rank|||||||0.9505
91676191|NCT01196078|183247062|SUPERIORITY_OR_OTHER|||||||0.2314|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.2314
91676192|NCT01196078|183247064|SUPERIORITY_OR_OTHER|||||||0.9894|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.9894
91676193|NCT01196078|183247066|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||PWB, Baseline versus Endpoint||||0.0060
91676194|NCT01196078|183247066|SUPERIORITY_OR_OTHER|||||||0.6871|||||||ANOVA|||SWB, Baseline versus Endpoint||||0.6871
91676195|NCT01196078|183247066|SUPERIORITY_OR_OTHER|||||||0.5104|||||||ANOVA|||EWB Baseline versus Endpoint||||0.5104
91676196|NCT01196078|183247066|SUPERIORITY_OR_OTHER|||||||0.9927|||||||ANOVA|||FWB, Baseline versus Endpoint||||0.9927
91676197|NCT01196078|183247066|SUPERIORITY_OR_OTHER|||||||0.3581|||||||ANOVA|||LCS, Baseline versus Endpoint||||0.3581
91676198|NCT03687658|183247079|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.066|||||||Generalized linear mixed model|||||||0.066
91676199|NCT03687658|183247080|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.273|||||||Generalized linear mixed model|||||||0.273
91676200|NCT03687658|183247081|OTHER|Generalized linear mixed model (GLMM) with a Poisson distribution using a log link function||||||0.403|||||||Generalized linear mixed model|||||||0.403
91676201|NCT04397445|183247082|SUPERIORITY|||||||0.54||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is 0 (-6.9 to 0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.54
91486401|NCT00408629|182845378|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
91526664|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.01|TWO_SIDED|95.0|1.4|3.49|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for Median number of sexual partners \>=2 in the past 30 days|Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||3.49|1.40|<0.01
91692263|NCT00529087|183279543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.731||95.0|-5.4|7.7|||ANCOVA|Treatment as factor, Baseline as covariate||||7.7|-5.4|0.731
91486402|NCT00408629|182845379|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
91642683|NCT04584294|183177374|SUPERIORITY||Odds Ratio (OR)|1.37||||0.26|TWO_SIDED|95.0|0.79|2.38||Threshold for significance was set at p\<0.05.|Regression, Logistic|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach. Analyses accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).||2.38|0.79|0.26
91676202|NCT04397445|183247082|SUPERIORITY|||||||0.71||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is -1.1 (-9.1 to 11.5) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.71
91642684|NCT04584294|183177374|SUPERIORITY||Odds Ratio (OR)|3.46||||0.019|TWO_SIDED|95.0|1.23|9.76||Threshold for significance was set at p\<0.05.|Regression, Logistic|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R."||9.76|1.23|0.019
91642685|NCT04584294|183177375|SUPERIORITY||Median Difference (Final Values)|-0.62||||0.27|TWO_SIDED|95.0|-1.71|0.48||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach. Analyses accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).||0.48|-1.71|0.27
91642686|NCT04584294|183177375|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.42|TWO_SIDED|95.0|-2.91|1.22||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R."||1.22|-2.91|0.42
91642687|NCT04584294|183177376|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.45|TWO_SIDED|95.0|-0.56|1.26||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.||1.26|-0.56|0.45
91642688|NCT04584294|183177376|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.09|TWO_SIDED|95.0|-0.15|2.02||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome."||2.02|-0.15|0.09
91642689|NCT04584294|183177377|SUPERIORITY||Mean Difference (Final Values)|-2.26||||0.56|TWO_SIDED|95.0|-9.94|5.42||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||We used a multilevel regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.||5.42|-9.94|0.56
91642690|NCT04584294|183177377|SUPERIORITY||Mean Difference (Final Values)|-13.72||||0.02|TWO_SIDED|95.0|-25.37|-2.06||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome."||-2.06|-25.37|0.02
91642691|NCT04584294|183177378|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.84|TWO_SIDED|95.0|-0.38|0.47||Threshold for significance was set at p\<0.05.|Regression, Linear|||We used a multilevel regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.||0.47|-0.38|0.84
91642692|NCT04584294|183177378|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.27|TWO_SIDED|95.0|-0.35|1.25||Threshold for significance was set at p\<0.05.|Regression, Linear|||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome."||1.25|-0.35|0.27
91642693|NCT04584294|183177390|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.21|TWO_SIDED|95.0|-0.22|0.99||threshold for significance set at \<0.05|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.||0.99|-0.22|0.21
91486403|NCT00408629|182845380|SUPERIORITY_OR_OTHER|||||||0.032||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure were needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.032
91676203|NCT04397445|183247083|SUPERIORITY|||||||0.005||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 9.3 (3.8 to 25.0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.005
91692264|NCT00529087|183279543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.779||95.0|-5.6|7.5|||ANCOVA|Treatment as factor, Baseline as covariate||||7.5|-5.6|0.779
91486404|NCT00408629|182845381|SUPERIORITY_OR_OTHER|||||||0.009||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.009
91642694|NCT04584294|183177390|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.04||95.0|0.04|1.75||Threshold for significance was set at p\<0.05.|Regression, Linear|Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.||"Per the study protocol, to account for noncompliance, we estimated the complier average causal effect to estimate the causal effect of using the MyPath tool on the outcome."||1.75|0.04|0.04
91642695|NCT00318357|183177397|SUPERIORITY|||||||0.007|||||||Regression, Cox|||Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.||||0.007
91642696|NCT01392469|183177398|SUPERIORITY||Ratio (Test/Reference)|1.17|||||TWO_SIDED|90.0|1.03|1.33||||||||1.33|1.03|
91642697|NCT01392469|183177398|SUPERIORITY||Ratio (Test/Reference)|1.4|||||TWO_SIDED|90.0|1.23|1.59||||||||1.59|1.23|
91642698|NCT01392469|183177399|SUPERIORITY||Ratio (Test/Reference)|1.36|||||TWO_SIDED|90.0|1.14|1.62||||||||1.62|1.14|
91642699|NCT01392469|183177399|SUPERIORITY||Ratio (Test/Reference)|1.7|||||TWO_SIDED|90.0|1.43|2.03||||||||2.03|1.43|
91642700|NCT01392469|183177400|SUPERIORITY||Ratio (Test/Reference)|1.0|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
91642701|NCT01392469|183177400|SUPERIORITY||Ratio (Test/Reference)|1.07|||||TWO_SIDED|90.0|0.88|1.31||||||||1.31|0.88|
91642702|NCT01392469|183177401|SUPERIORITY||Ratio (Test/Reference)|1.28|||||TWO_SIDED|90.0|1.03|1.61||||||||1.61|1.03|
91642703|NCT01392469|183177401|SUPERIORITY||Ratio (Test/Reference)|1.56|||||TWO_SIDED|90.0|1.24|1.95||||||||1.95|1.24|
91642704|NCT01256086|183177405|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Relative potency of Novolizer compared to Aerolizer. Equivalence was to be concluded if the CI for the relative potency was completely covered by the interval (0.67, 1.50) according to OIP Guideline.|Relative potency|1.13|||||TWO_SIDED|90.0|0.94|1.38|||||Fieller confidence interval for logarithm of relative potency|||1.38|0.94|
91642705|NCT03443973|183177408|SUPERIORITY||Difference in Adjusted mean|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2998|TWO_SIDED|95.0|-0.55|0.17|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline ADAS COG13 + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.17|-0.55|0.2998
91642706|NCT03443973|183177414|SUPERIORITY||Difference in adjusted mean|-1.28|STANDARD_ERROR_OF_MEAN|0.58||0.0273|TWO_SIDED|95.0|-2.41|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4||-0.14|-2.41|0.0273
91642707|NCT03443973|183177415|SUPERIORITY||Difference in adjusted mean|0.82|STANDARD_ERROR_OF_MEAN|0.78||0.2918|TWO_SIDED|95.0|-0.7|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4||2.34|-0.70|0.2918
91642708|NCT03443973|183177416|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.43||0.0438|TWO_SIDED|95.0|-1.7|-0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.02|-1.70|0.0438
91642709|NCT03443973|183177417|SUPERIORITY||Difference in adjusted mean|0.52|STANDARD_ERROR_OF_MEAN|0.27||0.0566|TWO_SIDED|95.0|-0.01|1.06|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||1.06|-0.01|0.0566
91642710|NCT03443973|183177418|SUPERIORITY||Difference in adjusted mean|-1.19|STANDARD_ERROR_OF_MEAN|0.53||0.026|TWO_SIDED|95.0|-2.24|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.14|-2.24|0.0260
91642711|NCT03443973|183177419|SUPERIORITY||Difference in adjusted mean|-0.03|STANDARD_ERROR_OF_MEAN|0.28||0.9086|TWO_SIDED|95.0|-0.59|0.52|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.52|-0.59|0.9086
91486405|NCT00408629|182845382|SUPERIORITY_OR_OTHER|||||||0.013||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.013
91486406|NCT00408629|182845383|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
91486407|NCT00408629|182845384|SUPERIORITY_OR_OTHER|||||||0.058||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.058
91676204|NCT04397445|183247083|SUPERIORITY|||||||0.007||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 6.4 (0 to 23.4) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.007
91676205|NCT04397445|183247084|OTHER||Geometric Mean Ratio|0.94||||0.92|TWO_SIDED|90.0|0.87|1.01||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.01|0.87|0.92
91676206|NCT04397445|183247084|OTHER||Geometric Mean Ratio|0.95||||0.74|TWO_SIDED|90.0|0.81|1.1||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.10|0.81|0.74
91676207|NCT04397445|183247084|OTHER||Geometric Mean Ratio|1.05||||0.52|TWO_SIDED|95.0|0.9|1.23||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.23|0.90|0.52
91676208|NCT04397445|183247084|OTHER||Geometric Mean Ratio|1.05||||0.42|TWO_SIDED|95.0|0.93|1.19||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.19|0.93|0.42
91676209|NCT04397445|183247085|OTHER||Geometric Mean Ratio|0.81||||0.001|TWO_SIDED|95.0|0.72|0.91||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.91|0.72|0.001
91676210|NCT04397445|183247087|OTHER||Geometric Mean Ratio|1.0||||0.46|TWO_SIDED|90.0|0.91|1.11||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.11|0.91|0.46
91676211|NCT04397445|183247087|OTHER||Geometric Mean Ratio|1.0||||0.49|TWO_SIDED|90.0|0.8|1.25||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from ranitidine (numerator) with placebo (denominator)|1.25|0.80|0.49
91692265|NCT00529087|183279544|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.023||95.0|0.8|10.4|||ANCOVA|Treatment as factor, baseline as covariate||||10.4|0.8|0.023
91692266|NCT00529087|183279544|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.8||||0.258||95.0|-2.0|7.6|||ANCOVA|Treatment as factor, baseline as covariate||||7.6|-2.0|0.258
91692267|NCT00529087|183279546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.0||||0.071||95.0|-0.6|14.5|||ANCOVA|Treatment as factor, baseline as covariate||||14.5|-0.6|0.071
91692268|NCT00529087|183279546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.087||95.0|-1.0|14.2|||ANCOVA|Treatment as factor, baseline as covariate||||14.2|-1.0|0.087
91692269|NCT00529087|183279547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6||||0.038||95.0|0.4|14.7|||ANCOVA|Treatment as factor, baseline as covariate||||14.7|0.4|0.038
91486408|NCT00408629|182845385|SUPERIORITY_OR_OTHER|||||||0.028||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.028
91642712|NCT03443973|183177420|SUPERIORITY||Difference in adjusted mean|1.41|STANDARD_ERROR_OF_MEAN|0.76||0.0629|TWO_SIDED|95.0|-0.08|2.9|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.90|-0.08|0.0629
91676212|NCT04397445|183247087|OTHER||Geometric Mean Ratio|0.8||||0.02|TWO_SIDED|95.0|0.67|0.95||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||0.95|0.67|0.02
91676213|NCT04397445|183247087|OTHER||Geometric Mean Ratio|0.8||||0.03|TWO_SIDED|95.0|0.65|0.98||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.98|0.65|0.03
91676214|NCT04397445|183247088|OTHER||Geometric Mean Ratio|0.77||||0.002|TWO_SIDED|95.0|0.66|0.89||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator).|As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||0.89|0.66|0.002
91676215|NCT03728634|183247136|SUPERIORITY||||||<|0.001|||||||Analysis of Variance(ANOVA)|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
91676216|NCT03728634|183247136|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
91676217|NCT03728634|183247136|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
91676218|NCT03728634|183247136|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
91676219|NCT03728634|183247136|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
91676220|NCT03728634|183247136|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
91526665|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.86|TWO_SIDED|95.0|0.45|1.85|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Traded sex for money or drugs in the past 30 days|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||1.85|0.45|0.86
91642713|NCT03443973|183177421|SUPERIORITY||Difference in adjusted mean|0.79|STANDARD_ERROR_OF_MEAN|0.66||0.2348|TWO_SIDED|95.0|-0.51|2.09|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.09|-0.51|0.2348
91676221|NCT03728634|183247136|SUPERIORITY|||||||0.036|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
91676222|NCT03728634|183247137|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
91676223|NCT03728634|183247137|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
91676224|NCT03728634|183247137|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
91676225|NCT03728634|183247137|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
91676226|NCT03728634|183247137|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
91676227|NCT03728634|183247137|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
91676228|NCT03728634|183247137|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Exact Test (2-sided)|||Change From Baseline in Plasma RBP4 Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
91676229|NCT02011113|183247153|SUPERIORITY_OR_OTHER|||||||0.0027||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)|Binomial test for dichotomized response|||||||0.0027
91676230|NCT01338649|183247164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0211|||||||t-test, 2 sided|t-test on two groups of differences||||||0.0211
91676231|NCT04688931|183247165|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.45|||||TWO_SIDED|95.0|0.29|0.68|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.68|0.29|
91676232|NCT04688931|183247166|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.3|0.7|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.70|0.30|
91676233|NCT04688931|183247168|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.24|0.86|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.86|0.24|
91642714|NCT03443973|183177428|SUPERIORITY||Difference in adjusted means|-56.46|STANDARD_ERROR_OF_MEAN|3.976|<|0.0001|TWO_SIDED|95.0|-64.36|-48.56|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-48.56|-64.36|<.0001
91642715|NCT03443973|183177429|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
91642716|NCT03443973|183177429|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
91642717|NCT03443973|183177429|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
91642718|NCT03443973|183177429|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
91642719|NCT03443973|183177430|SUPERIORITY||Percent Difference in Geometric Mean|-13.2||||0.014|TWO_SIDED|95.0|-22.51|-2.87|||ANCOVA|||||-2.87|-22.51|0.014
91642720|NCT03443973|183177431|SUPERIORITY||Percent Difference in Geometric Mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.88|-6.21|||ANCOVA|||||-6.21|-21.88|<0.001
91642721|NCT03443973|183177432|SUPERIORITY||Percent Difference in Geometric Mean|-17.8|||<|0.001|TWO_SIDED|95.0|-24.92|-10.11|||ANCOVA|||||-10.11|-24.92|<0.001
91642722|NCT03443973|183177433|SUPERIORITY||Percent Difference in Geometric Mean|-21.0|||<|0.001|TWO_SIDED|95.0|-28.29|-12.97|||ANCOVA|||||-12.97|-28.29|<0.001
91642723|NCT04633434|183177457|EQUIVALENCE|Test of whether the pretest and posttest scores are significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.56||0.69|TWO_SIDED||||||t-test, 2 sided||Estimation parameter based on paired t-test.|||||.690
91642724|NCT04633434|183177458|EQUIVALENCE|Test of whether pretest to posttest score change is greater than zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.308||0.052|TWO_SIDED||||||t-test, 2 sided|||||||.052
91642725|NCT04633434|183177459|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.41||0.135|TWO_SIDED||||||t-test, 2 sided|||||||.135
91676234|NCT00361335|183247177|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VI at α = 0.05.||||0.051
91692270|NCT00529087|183279547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.237||95.0|-2.8|11.5|||ANCOVA|Treatment as factor, baseline as covariate||||11.5|-2.8|0.237
91642726|NCT04633434|183177460|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|7.14||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
91642727|NCT04633434|183177461|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91642728|NCT04633434|183177462|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91642729|NCT04633434|183177463|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.54||0.057|TWO_SIDED||||||t-test, 2 sided|||||||.057
91642730|NCT04633434|183177464|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91642731|NCT04633434|183177465|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.352|TWO_SIDED||||||t-test, 2 sided|||||||.352
91642732|NCT04633434|183177466|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13||0.104|TWO_SIDED||||||t-test, 2 sided|||||||.104
91642733|NCT04633434|183177469|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.106|TWO_SIDED||||||t-test, 2 sided|||||||.106
91642734|NCT04633434|183177470|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED||||||t-test, 2 sided|||||||.005
91642735|NCT04633434|183177471|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|1.9||0.082|TWO_SIDED||||||t-test, 2 sided|||||||.082
91642736|NCT02329834|183177479|EQUIVALENCE|90% Confidence Interval 80\<ratio of AUC\<125. The FDA guided Bioequivalence limit of 80 to 125% for the ratio of the product averages has been adopted for use of an average BE criterion.|% diff Geometric Least Squared Mean|99.5|||||TWO_SIDED|90.0|94.77|104.75||||||||104.75|94.77|
91692271|NCT01598064|183279548|SUPERIORITY_OR_OTHER|||||||0.25|||||||Chi-squared|||||||0.25
91676235|NCT00361335|183247177|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31% response in the Group I at α = 0.05.||||0.073
91676236|NCT00361335|183247177|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group III at α = 0.05.||||0.093
91486409|NCT00408629|182845386|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
91642737|NCT02329834|183177480|OTHER||% Diff Geometric Least Squared Mean|99.65|||||TWO_SIDED|90.0|94.79|104.75||||||||104.75|94.79|
91642738|NCT00659945|183177486|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||The primary endpoint was the incidence of emesis at any time within the first 48 hours after surgery. Power analysis showed that a sample size of 69 patients per group was necessary to detect a significant decrease in the incidence of emesis from 33% in the placebo group to 15% in the aprepitant group using a Chi-square test with an alpha value of 0.05 and power of 80%.||||<0.05
91642739|NCT01976104|183177506|SUPERIORITY||Difference of proportion versus placebo|33.7|||=|0.0006|TWO_SIDED|95.0|15.8|51.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||51.6|15.8|=0.0006
91642740|NCT01976104|183177506|SUPERIORITY||Difference of proportion versus placebo|54.6|||<|0.0001|TWO_SIDED|95.0|36.5|72.7|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||72.7|36.5|<0.0001
91642741|NCT01976104|183177507|SUPERIORITY||Difference of proportion versus placebo|60.2|||<|0.0001|TWO_SIDED|95.0|46.8|73.5|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||73.5|46.8|<0.0001
91642742|NCT01976104|183177507|SUPERIORITY||Difference of proportion versus placebo|53.7|||<|0.0001|TWO_SIDED|95.0|35.8|71.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||71.6|35.8|<0.0001
91642743|NCT01976104|183177508|SUPERIORITY||Difference in change of platelet count|25.4|||<|0.0001|TWO_SIDED|95.0|19.5|32.0|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI|||32.0|19.5|<0.0001
91642744|NCT01976104|183177508|SUPERIORITY||Difference in change of platelet count|36.3|||<|0.0001|TWO_SIDED|95.0|25.5|45.5|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||45.5|25.5|<0.0001
91642745|NCT01353209|183177516|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.4
91642746|NCT01353209|183177517|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.7
91642747|NCT01353209|183177518|SUPERIORITY|||||||0.8|||||||Regression, Linear|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.8
91642748|NCT01353209|183177518|SUPERIORITY|||||||0.8|||||||Regression, Linear|||||||.8
91642749|NCT01353209|183177519|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use. P value was obtained for testing zero slope for log(VEGF-D).||||||0.015
91642750|NCT01283009|183177520|SUPERIORITY||Odds Ratio (OR)|0.9||||0.635|TWO_SIDED|95.0|0.58|1.4|||Mantel Haenszel|||||1.40|0.58|0.635
91642751|NCT03237325|183177539|SUPERIORITY|||||||0.1798|||||||Log Rank|||||||0.1798
91676237|NCT00361335|183247177|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VII at α = 0.05.||||0.465
91676238|NCT00361335|183247177|SUPERIORITY_OR_OTHER|||||||0.872||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group II at α = 0.05.||||0.872
91676239|NCT00361335|183247177|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the combined group (I and III) at α = 0.05.||||0.175
91676240|NCT00361335|183247178|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.||||0.002
91676241|NCT00361335|183247178|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.||||0.032
91676242|NCT00361335|183247178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.||||<0.001
91676243|NCT00361335|183247178|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.||||0.795
91676244|NCT00361335|183247178|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.||||0.844
91676245|NCT00361335|183247178|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.540
91676246|NCT00361335|183247179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
91676247|NCT00361335|183247179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
91676248|NCT00361335|183247179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
91676249|NCT00361335|183247179|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||0.002
91676250|NCT00361335|183247179|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.043
91526666|NCT00244374|182928666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.59|2.02|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for condom use \>90% (if sexually active)|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 days||2.02|0.59|0.73
91676251|NCT00361335|183247179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||<0.001
91676252|NCT00361335|183247180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
91676253|NCT00361335|183247180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
91676254|NCT00361335|183247180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
91676255|NCT00361335|183247180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||<0.001
91676256|NCT00361335|183247180|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.003
91676257|NCT00361335|183247180|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|No adjustments were made to control for multiplicity||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.001
91676258|NCT00361335|183247181|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||0.005
91676259|NCT00361335|183247181|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||0.014
91676260|NCT00361335|183247181|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||0.014
91486410|NCT00408629|182845387|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
91486411|NCT00408629|182845388|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
91486412|NCT00408629|182845389|SUPERIORITY_OR_OTHER|||||||0.007||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.007
91642752|NCT02684370|183177540|OTHER||adjusted difference in percentage|70.3|||<|0.001|TWO_SIDED|95.0|64.0|76.7||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||76.7|64.0|<0.001
91642753|NCT02684370|183177541|OTHER||adjusted difference in percentage|79.9|||<|0.001|TWO_SIDED|95.0|73.5|86.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.3|73.5|<0.001
91642754|NCT02684370|183177542|OTHER||adjusted difference in percentage|34.7|||<|0.001|TWO_SIDED|95.0|28.6|40.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.8|28.6|<0.001
91642755|NCT02684370|183177543|OTHER||adjusted difference in percentage|35.5|||<|0.001|TWO_SIDED|95.0|30.0|41.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||41.0|30.0|< 0.001
91642756|NCT02684370|183177544|OTHER||adjusted difference in percentage|57.9|||<|0.001|TWO_SIDED|95.0|50.4|65.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||65.3|50.4|< 0.001
91642757|NCT02684370|183177545|OTHER||adjusted difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|21.2|32.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.9|21.2|< 0.001
91642758|NCT02684370|183177546|OTHER||adjusted difference in percentage|33.5|||<|0.001|TWO_SIDED|95.0|22.7|44.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.3|22.7|< 0.001
91676261|NCT00361335|183247181|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.||||0.996
91676262|NCT00361335|183247181|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.738
91676263|NCT00361335|183247181|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||No adjustments were made to control for multiplicity|2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.788
91676264|NCT01765582|183247197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.132|TWO_SIDED|90.0|0.96|2.71|||Cochran-Mantel-Haenszel|||Stratified by extent of metastatic disease (liver-limited disease versus non liver-limited disease) and tumor location (right versus left) after correction post-randomization.||2.71|0.96|0.132
91486413|NCT00408629|182845390|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
91486414|NCT01461980|182845391|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03||||||Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).||1.03|0.86|
91676265|NCT01765582|183247198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.005|TWO_SIDED|90.0|0.53|0.88|||Log Rank|||Stratified by extent of metastatic disease (liver-limited disease vs. non-liver-limited disease) and tumor location (right vs. left) after correction post-randomization.||0.88|0.53|0.005
91676266|NCT00714493|183247234|SUPERIORITY_OR_OTHER||change from baseline||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91676267|NCT00714493|183247235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91676268|NCT00076804|183247238|SUPERIORITY_OR_OTHER|||||||0.42||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.42
91676269|NCT00076804|183247239|SUPERIORITY_OR_OTHER|||||||0.89||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.89
91676270|NCT00076804|183247240|SUPERIORITY_OR_OTHER|||||||0.14||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.14
91676271|NCT00076804|183247241|SUPERIORITY_OR_OTHER|||||||0.61||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.61
91676272|NCT00354341|183247242|SUPERIORITY_OR_OTHER|||||||0.8811|TWO_SIDED|||||P-value was calculated by ANCOVA with last observation carry forward (LOCF) method.|ANCOVA with LOCF|||||||0.8811
91676273|NCT00354341|183247243|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED||||||ANCOVA with LOCF|||||||0.8864
91526667|NCT01411501|182928674|SUPERIORITY_OR_OTHER|||||||0.352|TWO_SIDED||||||ANCOVA|||||||0.352
91526668|NCT01411501|182928675|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANCOVA|||||||0.968
91526669|NCT01411501|182928676|SUPERIORITY_OR_OTHER|||||||0.841|TWO_SIDED||||||Kruskal-Wallis|||||||0.841
91676274|NCT00354341|183247244|SUPERIORITY_OR_OTHER|||||||0.5681|TWO_SIDED||||||ANCOVA with LOCF|||||||0.5681
91676275|NCT00354341|183247245|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA with LOCF|||||||0.1578
91676276|NCT00354341|183247246|SUPERIORITY_OR_OTHER|||||||0.2913|TWO_SIDED||||||ANCOVA with LOCF|||||||0.2913
91676277|NCT00354341|183247247|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
91676278|NCT00251719|183247248|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|2.34||||0.234||95.0|-1.45|6.14||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||6.14|-1.45|0.234
91676279|NCT00251719|183247248|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|4.85||||0.019||95.0|1.2|8.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||8.50|1.20|0.019
91486415|NCT01461980|182845391|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.85|0.99||||||Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).||0.99|0.85|
91676280|NCT00251719|183247248|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.220
91676281|NCT00251719|183247249|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.768
91676282|NCT00251719|183247249|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.064
91676283|NCT00251719|183247249|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.034
91676284|NCT00251719|183247250|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.727
91676285|NCT00251719|183247250|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.064
91676286|NCT00251719|183247250|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.174
91676287|NCT00251719|183247251|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|1.65||||0.167||95.0|-1.65|4.96||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||4.96|-1.65|0.167
91676288|NCT00251719|183247251|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|3.39||||0.03||95.0|0.27|6.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||6.50|0.27|0.030
91676289|NCT00251719|183247251|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.413
91676290|NCT00251719|183247252|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.100
91526670|NCT01411501|182928677|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
91676291|NCT00251719|183247252|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.125
91676292|NCT00251719|183247252|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.993
91676293|NCT00251719|183247253|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.117
91676294|NCT00251719|183247253|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.124
91676295|NCT00251719|183247253|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.949
91676296|NCT03709823|183247269|SUPERIORITY||LS Mean Difference vs. Placebo|-20.48||||0.0002|TWO_SIDED|95.0|-31.141|-9.821||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-9.821|-31.141|0.0002
91676297|NCT03709823|183247269|SUPERIORITY||LS Mean Difference vs. Placebo|-22.07|||<|0.0001|TWO_SIDED|95.0|-32.791|-11.342||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-11.342|-32.791|< 0.0001
91676298|NCT03709823|183247269|SUPERIORITY||LS Mean Difference vs. Placebo|-5.9||||0.2708|TWO_SIDED|95.0|-16.463|4.66||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||4.660|-16.463|0.2708
91676299|NCT03709823|183247269|SUPERIORITY||LS Mean Difference vs. Placebo|-2.81||||0.6018|TWO_SIDED|95.0|-13.438|7.82||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||7.820|-13.438|0.6018
91676300|NCT03709823|183247269|SUPERIORITY||LS Mean Difference vs. Commercial Sched.|-12.17||||0.1025|TWO_SIDED|95.0|-26.869|2.535||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||2.535|-26.869|0.1025
91486416|NCT01461980|182845392|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).||1.02|0.85|
91486417|NCT01461980|182845392|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98||||||Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).||0.98|0.84|
91526671|NCT01411501|182928678|SUPERIORITY_OR_OTHER|||||||0.198|TWO_SIDED||||||ANCOVA|||||||0.198
91526672|NCT01411501|182928679|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||||||0.035
91526673|NCT00708721|182928680|OTHER||Maximum Tolerated Dose|1.0|||||TWO_SIDED||||||||Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.|||||
91526674|NCT01966796|182928688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||The incidence of MDR pathogens (6.7%, 25.5%, 36.9% and 44.6% in PSI II, III, IV, and V, respectively, p=0.002) and mortality rate (0, 5.9%, 12.3%, and 23.8%, respectively, p\<0.001) increased with increasing PSI||||0.002
91676301|NCT03709823|183247270|SUPERIORITY||LS Mean Difference vs. Placebo|-14.61||||0.001|TWO_SIDED|95.0|-23.216|-6.009||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-6.009|-23.216|0.0010
91676302|NCT03709823|183247270|SUPERIORITY||LS Mean Difference vs. Placebo|-16.2||||0.0003|TWO_SIDED|95.0|-24.862|-7.548||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-7.548|-24.862|0.0003
91676303|NCT03709823|183247271|SUPERIORITY||LS Mean Difference vs. Placebo|-12.41||||0.0091|TWO_SIDED|95.0|-21.695|-3.135||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-3.135|-21.695|0.0091
91676304|NCT03709823|183247271|SUPERIORITY||LS Mean Difference vs. Placebo|-9.3||||0.0518|TWO_SIDED|95.0|-18.667|0.075||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||0.075|-18.667|0.0518
91676305|NCT02737332|183247272|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio of treatments|1.019||||0.4879|TWO_SIDED|90.0|0.964|1.077||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.077|0.964|0.4879
91676306|NCT02737332|183247273|OTHER|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.994||||0.3642|TWO_SIDED|90.0|0.0451|2.192||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.192|0.0451|0.3642
91676307|NCT02737332|183247273|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.81||||0.4069|TWO_SIDED|90.0|0.338|1.939||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.939|0.338|0.4069
91676308|NCT02737332|183247273|EQUIVALENCE|One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|Geometric mean ratio|1.039||||0.7186|TWO_SIDED|90.0|0.412|2.617||The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.617|0.412|0.7186
91676309|NCT02737332|183247274|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91676310|NCT02737332|183247275|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.999||||0.9211|TWO_SIDED|90.0|0.98|1.018||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.||ANOVA-model-based Least-Square Mean|1.018|0.980|0.9211
91692076|NCT03771898|183278778|SUPERIORITY|Survival probability free of loss of locomotion estimated up to Week 106 (or two years).|Difference in survival probability (%)|-2.2|||=|0.585|TWO_SIDED|95.0|-22.2|17.7||One-sided, over time intervals during entire follow-up. Stratified generalized log-rank test was used, where matching identification created from matching process in SAS PSMATCH Procedure used as strata.|Log Rank||For the shared time interval up to Week 106 (or two years).|Interval censoring survival analysis.||17.7|-22.2|=0.585
91486418|NCT01461980|182845392|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.98||||||Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).||0.98|0.80|
91486419|NCT01461980|182845392|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.08||||||Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).||1.08|0.74|
91676311|NCT02737332|183247275|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.168||||0.3037|TWO_SIDED|90.0|0.9|1.515||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.515|0.900|0.3037
91676312|NCT02737332|183247275|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.0||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.000|1.000|
91676313|NCT02737332|183247276|OTHER|||||||0.5495|||||||ANOVA|||||||0.5495
91676314|NCT02737332|183247276|OTHER|||||||0.2616|||||||ANOVA|||||||0.2616
91676315|NCT02737332|183247276|OTHER|||||||0.3632|||||||ANOVA|||||||0.3632
91676316|NCT02737332|183247276|OTHER|||||||0.3393|||||||ANOVA|||||||0.3393
91486420|NCT01461980|182845393|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.01||||||Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).||1.01|0.82|
91676317|NCT02737332|183247280|OTHER|||||||0.1917|||||||ANOVA|||||||0.1917
91676318|NCT00688376|183247281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8||||0.694|TWO_SIDED|95.0|-3.22|4.8|||ANCOVA|||P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.||4.8|-3.22|0.694
91676319|NCT00688376|183247282|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.9458|TWO_SIDED|95.0|-4.38|4.09|||ANCOVA|||P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.09|-4.38|0.9458
91676320|NCT00688376|183247283|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4||||0.743|TWO_SIDED|95.0|-9.56|6.85|||ANCOVA|||RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6.85|-9.56|0.743
91676321|NCT00688376|183247283|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.9561|TWO_SIDED|95.0|-7.42|7.84|||ANCOVA|||RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||7.84|-7.42|0.9561
91676322|NCT00688376|183247283|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.5||||0.4385|TWO_SIDED|95.0|-3.97|9.04|||ANCOVA|||RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||9.04|-3.97|0.4385
91676323|NCT00688376|183247283|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.9088|TWO_SIDED|95.0|-6.74|6.0|||ANCOVA|||RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6|-6.74|0.9088
91676324|NCT00688376|183247284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.2886|TWO_SIDED|95.0|-1.5|4.96|||ANCOVA|||Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.96|-1.5|0.2886
91676325|NCT00688376|183247284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.1||||0.2555|TWO_SIDED|95.0|-1.54|5.69|||ANCOVA|||Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||5.69|-1.54|0.2555
91676326|NCT00688376|183247284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.3155|TWO_SIDED|95.0|-1.63|4.99|||ANCOVA|||Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.99|-1.63|0.3155
91676327|NCT00688376|183247284|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.9075|TWO_SIDED|95.0|-3.55|3.16|||ANCOVA|||Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||3.16|-3.55|0.9075
91692077|NCT03123120|183278800|OTHER||Risk Difference (RD)|-0.232|||||TWO_SIDED|95.0|-0.568|0.118|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.118|-0.568|
91486421|NCT01461980|182845393|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).||1.15|0.90|
91486422|NCT01461980|182845393|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.89|1.09||||||Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).||1.09|0.89|
91486423|NCT01461980|182845393|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).||1.04|0.83|
91526675|NCT03661996|182928693|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.063|STANDARD_ERROR_OF_MEAN|1.0216|||TWO_SIDED|95.0|1.019|1.108|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.108|1.019|
91676328|NCT00557076|183247285|NON_INFERIORITY_OR_EQUIVALENCE|Because 50% of the planned sample size was randomized, achieved power for the DOCS is 0.51.|Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|7.0||0.465|TWO_SIDED|95.0|-11.1|21.9|||t-test, 1 sided|DOCS scores were transformed to interval level measures using a many-faceted Rasch model anchored to values from a larger validation data set|The mean difference between the baseline and endpoint DOCS test was compared between the FAST and Sham groups.|The planned sample of 15 per group provided 80% power for a one-sided t-test to detect be-tween group endpoint differences in DOCS averages equivalent to an effect size of .91 (9 units). Clinically, this assumes that the FAST protocol would facilitate progression from one clinical state to another (e.g., vegetative (VS) to minimally conscious (MCS) states). The hypothesized effect was based on average DOCS change for a severe TBI sample receiving three weeks of acute rehabilitation.||21.9|-11.1|.465
91676329|NCT00557076|183247286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.346||0.049|TWO_SIDED|95.0|-1.51|-0.00493|||t-test, 1 sided|CNC scores were transformed to interval level measures using Rasch partial credit and Facets models. We then re-scaled these logits to 0-100 scales.|The mean difference was calculated for each group using the eighth CNC measure minus the Baseline CNC measure.|Power was not calculated for the CNC because the effect size was not published.||-.00493|-1.51|0.049
91676330|NCT00557076|183247286|SUPERIORITY_OR_OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0022|TWO_SIDED|||||To confirm that CNC results were not an anomaly at the final measurement and that the overall CNC response pattern was consistent, mixed-effect longitudinal models were conducted.|t-test, 1 sided||The Baseline CNC measure and seven post-Baseline CNC measures (for a total of eight CNC measures) were used to calculate the slope.|||||.0022
91676331|NCT01517659|183247292|OTHER||Mean Difference (Final Values)|2.61|STANDARD_DEVIATION|2.29|||TWO_SIDED|95.0|2.23|3.27||||||||3.27|2.23|
91676332|NCT02792959|183247333|NON_INFERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
91676333|NCT02792959|183247334|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
91676334|NCT02792959|183247335|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.0||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
91676335|NCT02792959|183247336|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.091||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
91676336|NCT02792959|183247337|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
91676337|NCT02792959|183247338|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
91676338|NCT02792959|183247339|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.0||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
91676339|NCT02792959|183247340|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
91676340|NCT02792959|183247341|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
91676341|NCT02792959|183247342|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
91676342|NCT02792959|183247343|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
91676343|NCT02792959|183247344|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.705||||0.192|TWO_SIDED||||||Kruskal-Wallis|||||||0.192
91676344|NCT00894738|183247352|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The null hypothesis is that mean DEXA total percent fat is similar between the two groups of interest. The primary statistical model consisted of treatment group as a 2-level factor (AP-Treated Vs Non-AP Treated) and DEXA total percent fat as a covariate. Carotid intima-media thickness (CIMT) was the dependent variable.||||0.49
91692078|NCT03123120|183278801|OTHER||Risk Difference (RD)|-0.054|||||TWO_SIDED|95.0|-0.404|0.21|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.210|-0.404|
91642759|NCT02684370|183177547|OTHER||adjusted difference in percentage|25.1|||<|0.001|TWO_SIDED|95.0|15.2|35.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||35.0|15.2|< 0.001
91642760|NCT02684370|183177548|OTHER||adjusted difference in percentage|23.8|||<|0.001|TWO_SIDED|95.0|15.5|32.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.1|15.5|< 0.001
91676345|NCT00894738|183247353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The statistical analysis consisted of treatment group as a 2-level factor variable and DEXA total percent fat as a covariate. An interaction term between treatment group and DEXA total percent fat was also generated. Hepatic triglyceride content was the dependent variable. DEXA total percent fat was found to be significant while treatment group and the interaction between treatment group and DEXA total percent fat were not significant.||||<0.0001
91676346|NCT05070546|183247428|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\])|Geometric Mean Ratio|1.41|||||TWO_SIDED|95.0|1.25|1.6|||Geometric Mean Ratio|||||1.60|1.25|
91676347|NCT05070546|183247428|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\])|Geometric mean ratio|1.54|||||TWO_SIDED|95.0|1.34|1.78|||Geometric Mean Ratio|||||1.78|1.34|
91676348|NCT05070546|183247429|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\]).|Difference in Seroresponse rate|5.4|||||TWO_SIDED|95.0|0.3|10.9|||Difference in Seroresponse rate|||||10.9|0.3|
91676349|NCT05070546|183247429|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\]).|Difference in Seroresponse rate|4.4|||||TWO_SIDED|95.0|-1.6|10.5|||Difference in Seroresponse rate|||||10.5|-1.6|
91676350|NCT04988152|183247455|SUPERIORITY||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
91676351|NCT04988152|183247456|OTHER||Ratio of geometric least squares means|1.0513|||||TWO_SIDED|90.0|0.9281|1.1908|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||1.1908|0.9281|
91676352|NCT04988152|183247459|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
91676353|NCT04988152|183247460|OTHER||Ratio of geometric least squares means|1.5869|||||TWO_SIDED|90.0|1.1236|2.2413|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||2.2413|1.1236|
91676354|NCT04988152|183247475|OTHER||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
91676355|NCT04988152|183247477|OTHER||Ratio of geometric least squares means|1.0673|||||TWO_SIDED|90.0|0.9286|1.2268|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates.|||1.2268|0.9286|
91676356|NCT04988152|183247481|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
91676357|NCT04988152|183247483|OTHER||Ratio of geometric least squares means|1.5766|||||TWO_SIDED|90.0|1.1777|2.1106|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates|||2.1106|1.1777|
91676358|NCT01610453|183247508|SUPERIORITY_OR_OTHER||||||<|0.01||||||A sample size calculation with alpha 0.05, power 0.8, and cut-off level of HPD at 40 mm. 146 women should be included. The calculation was based from a previous study, in which 93% with HPD ≤40 mm and 57% of with HPD \> 40 mm delivered vaginally.|Chi-squared|||Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.||||<0.01
91676359|NCT01610453|183247509|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
91676360|NCT00988065|183247516|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
91676361|NCT00988065|183247516|SUPERIORITY_OR_OTHER||Difference in event rates|4.7||||||95.0|2.1|9.3|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||9.3|2.1|
91676362|NCT00988065|183247517|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
91717044|NCT01687218|183326478|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.46|TWO_SIDED|95.0|0.37|1.56|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.56|0.37|0.46
91717045|NCT01687218|183326479|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.65|0.22|0.0004
91717046|NCT01687218|183326479|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.39|1.25|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.25|0.39|0.23
91717047|NCT01687218|183326480|OTHER||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.53|-1.3|||Mixed Models Analysis||This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.30|-1.53|<0.001
91642761|NCT02684370|183177549|OTHER||adjusted difference in percentage|22.9|||<|0.001|TWO_SIDED|95.0|14.3|31.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.6|14.3|< 0.001
91642762|NCT02684370|183177550|OTHER||adjusted difference in percentage|38.3|||<|0.001|TWO_SIDED|95.0|27.9|48.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||48.6|27.9|< 0.001
91642763|NCT02684370|183177551|OTHER||adjusted difference in percentage|35.1|||<|0.001|TWO_SIDED|95.0|25.7|44.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.6|25.7|< 0.001
91642764|NCT02684370|183177552|OTHER||adjusted difference in percentage|36.5|||<|0.001|TWO_SIDED|95.0|27.0|45.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||45.9|27.0|< 0.001
91642765|NCT02684370|183177553|OTHER||adjusted difference in percentage|17.0|||<|0.001|TWO_SIDED|95.0|7.4|26.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||26.6|7.4|< 0.001
91642766|NCT02684370|183177554|OTHER||adjusted difference in percentage|17.3|||<|0.001|TWO_SIDED|95.0|7.3|27.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||27.3|7.3|< 0.001
91642767|NCT02684370|183177555|OTHER||adjusted difference in percentage|23.0|||<|0.001|TWO_SIDED|95.0|11.9|34.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||34.0|11.9|< 0.001
91642768|NCT02684370|183177556|OTHER||Mean Difference (Final Values)|-5.765|||<|0.001|TWO_SIDED|95.0|-6.496|-5.035|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.035|-6.496|<0.001
91642769|NCT00627094|183177564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0438|TWO_SIDED|95.0|1.02|2.96||In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.|Chi-squared|Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis||The null hypothesis to be tested was that the distributions of categorical responses were the same.||2.96|1.02|0.0438
91486424|NCT01461980|182845394|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02||||||PMB80 \[A22\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.02|0.84|
91527504|NCT04534114|182930303|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.27||||0.757|TWO_SIDED|95.0|0.28|5.66|||Log Rank|||||5.66|0.28|0.757
91642770|NCT02050373|183177594|OTHER|For the comparison between the LLLT and control groups the Pearson chi-square (χ2) or Fisher's Exact tests were used.|||||<|0.05|||||||Fisher Exact|||The Pearson chi-square (χ2) or Fisher's Exact tests were used, at three different times (AD, D7, HD), to analyze the oral mucositis severity in the comparison between the LLLT and control groups. Statistical analysis was not performed for each grade of oral mucositis separately.||||<0.05
91642771|NCT02050373|183177595|OTHER|Student's t test was used to numerical variables with normal distribution. The Mann-Whitney test was used to compare the cytokine values of the two groups (control and laser). The Friedman test was used to indicate differences by comparing cytokine levels at different times of assessment within each group. The Friedman and Wilcoxon tests were used for paired analyzes of the saliva collection times in the groups. All tests were used to compare the groups at the three different times (AD, D7, HD).|||||<|0.05||||||p\<0,05|Wilcoxon (Mann-Whitney)|||||||<0.05
91642772|NCT04342130|183177596|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91642773|NCT00807040|183177604|OTHER|We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.||||0.18
91642774|NCT00807040|183177605|OTHER|We used the log-rank test to compare rates of death from baseline to 2 years.|Hazard Ratio (HR)|0.79||||0.39|TWO_SIDED|95.0|0.46|1.35|||Log Rank|||||1.35|0.46|0.39
91642775|NCT01783860|183177622|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 1 sided|||||||0.03
91642776|NCT01783860|183177623|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
91642777|NCT01783860|183177624|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 1 sided|||||||0.007
91642778|NCT01783860|183177625|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 1 sided|||||||> 0.05
91642779|NCT01783860|183177626|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 1 sided|||||||0.02
91642780|NCT01783860|183177627|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 1 sided|||||||0.08
91642781|NCT03992261|183177629|OTHER|"Mean, median, SD, minimum/maximum determined for total amount of test article used by each subject in Safety, Evaluable, and PK populations HPA Axis Suppression: Proportion of subjects manifesting laboratory evidence of adrenal suppression at EOS were presented with 95% confidence intervals (CIs) for Evaluable and Safety populations. Descriptive statistics for daily dose of test article were tabulated separately for suppressed and non-suppressed subjects.~PK: Screening, Day 8, Day 15"||||||0.05|||||||ANOVA|||Outcome measure: extent of exposure, HPA axis suppression, and pharmacokinetic analysis.||||0.05
91642782|NCT00258310|183177630|SUPERIORITY_OR_OTHER_LEGACY||proportion|0.74|||||TWO_SIDED|95.0|0.59|0.9||||||||.90|.59|
91642783|NCT01833897|183177647|SUPERIORITY_OR_OTHER||||||<|0.001||||||F1,6.4=161.8,|linear mixed model|||||||<0.001
91642784|NCT01833897|183177648|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91676363|NCT00988065|183247517|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||2.5|-2.5|
91676364|NCT00988065|183247518|SUPERIORITY_OR_OTHER||Difference in event rates|2.0||||||95.0|-0.5|5.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||5.7|-0.5|
91642785|NCT01833897|183177649|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
91642786|NCT01833897|183177650|SUPERIORITY_OR_OTHER|||||||0.011|||||||ANOVA|||||||0.011
91642787|NCT01833897|183177651|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91642788|NCT02325739|183177658|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fasted) is 120mg.|||||
91642789|NCT02325739|183177658|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fed) is 120mg.|||||
91642790|NCT02325739|183177658|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for FGF401 120mg.|||||
91642791|NCT02325739|183177658|OTHER||RP2D|300.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for PDR001 300mg.|||||
91642792|NCT02255422|183177712|SUPERIORITY||LS mean difference (net)|-0.015|STANDARD_ERROR_OF_MEAN|0.0446||0.7321|TWO_SIDED|95.0|-0.1051|0.0743||P-Value relates to difference in change in peak work from baseline relative to placebo for all doses pooled. Statistical significance was defined as p\<0.05|Mixed Models Analysis|Null hypothesis: wk 12 mean change from baseline (\[μ RTA 408\] - \[μ Placebo\]) in peak work = 0 w/kg. Positive change from baseline suggests improvement||Primary Objective: To evaluate the change in peak work during maximal exercise testing||0.0743|-0.1051|0.7321
91676365|NCT00988065|183247518|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||2.5|-2.5|
91676366|NCT04319718|183247535|OTHER|||||||0.025|||||||Fisher Exact|||||||.025
91676367|NCT04319718|183247536|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
91676368|NCT04319718|183247540|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||.67
91676369|NCT04319718|183247541|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||.51
91676370|NCT04319718|183247542|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||.09
91676371|NCT04319718|183247543|OTHER|||||||0.65|||||||Mixed Models Analysis|||||||.65
91676372|NCT04319718|183247543|OTHER|||||||0.24|||||||Mixed Models Analysis|||||||.24
91676373|NCT04319718|183247543|OTHER|||||||0.27|||||||Mixed Models Analysis|||||||.27
91676374|NCT01030341|183247573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<50 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
91676375|NCT01030341|183247573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<70 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
91676376|NCT01030341|183247573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.005||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.||||0.005
91676377|NCT01030341|183247573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.04||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>180 mg/dL) during the screening phase and treatment phase respectively.||||0.04
91676378|NCT01030341|183247573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>300 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
91676379|NCT01030341|183247574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.||||<0.0001
91676380|NCT01030341|183247574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.||||<0.0001
91676381|NCT01030341|183247574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.||||<0.0001
91676382|NCT01030341|183247574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.||||<0.0001
91676383|NCT01030341|183247574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.||||<0.0001
91676384|NCT01030341|183247574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.||||<0.0001
91676385|NCT02307266|183247575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
91676386|NCT02307266|183247575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|||||||Cochran-Mantel-Haenszel|||||||0.0206
91676387|NCT01032018|183247585|SUPERIORITY_OR_OTHER||Difference of back-transformed means.|-3.5||||0.01||95.0|-6.1|-0.7|||Mixed Models Analysis|||The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.||-0.7|-6.1|0.01
91676388|NCT01796912|183247676|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91676389|NCT01796912|183247677|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91676390|NCT01796912|183247678|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91676391|NCT01796912|183247679|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
91676392|NCT01796912|183247680|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91676393|NCT01796912|183247681|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91676394|NCT01796912|183247682|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91676395|NCT00841906|183247698|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91692079|NCT03123120|183278802|OTHER||Risk Difference (RD)|-0.286|||||TWO_SIDED|95.0|-0.602|0.101|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.101|-0.602|
91692080|NCT03123120|183278803|OTHER||Risk Difference (RD)|0.143|||||TWO_SIDED|95.0|-0.197|0.399|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.399|-0.197|
91676396|NCT00903448|183247702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0||||The least squares treatment means, i.e. adjusted treatment means, and standard errors were computed from the analysis of variance models.|Mixed Models Analysis|||This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH \> 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.||||< 0.0001
91676397|NCT03537274|183247748|SUPERIORITY|||||||0.078|||||||Chi-squared|||||||0.078
91676398|NCT03537274|183247748|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
91676399|NCT03537274|183247748|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91676400|NCT03537274|183247749|SUPERIORITY|||||||0.128|||||||Chi-squared|||||||0.128
91676401|NCT03537274|183247749|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91676402|NCT03537274|183247749|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91676403|NCT00974974|183247791|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
91676404|NCT00974974|183247792|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
91676405|NCT01340768|183247804|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.52||||0.028|TWO_SIDED|95.0|0.29|0.94||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.94|0.29|0.028
91676406|NCT01340768|183247805|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.006|TWO_SIDED|95.0|0.29|0.83||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.83|0.29|0.006
91676407|NCT02397408|183247837|OTHER||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||||||<.008
91676408|NCT00985712|183247838|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6692|TWO_SIDED|95.0|-0.17|0.26|||Mixed Models Analysis|The model details are given in the section of Measure Description.||Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.||0.26|-0.17|0.6692
91676409|NCT00985712|183247839|SUPERIORITY_OR_OTHER|||||||0.3551||95.0||||P-value is for HbA1c ≤7.0%.|Chi-squared|||||||0.3551
91676410|NCT00985712|183247839|SUPERIORITY_OR_OTHER|||||||0.2026||95.0||||P-value is for HbA1c ≤7.5%.|Chi-squared|||||||0.2026
91676411|NCT00985712|183247840|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) was adjusted for baseline values.||||||0.9070
91676412|NCT00985712|183247841|SUPERIORITY_OR_OTHER|||||||0.9817||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9817
91676413|NCT00985712|183247842|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1187
91676414|NCT00279955|183247856|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.07|STANDARD_DEVIATION|0.292||0.0119|TWO_SIDED|95.0|1.17|3.67|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.|||3.67|1.17|0.0119
91676415|NCT00279955|183247857|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.9|STANDARD_DEVIATION|0.277||0.0185|TWO_SIDED|95.0|1.11|3.27|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing \<90% in last 21 days of DREP.|||3.27|1.11|0.0185
91676416|NCT00279955|183247858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|STANDARD_DEVIATION|0.311||0.0578|TWO_SIDED|95.0|0.98|3.31|||Regression, Cox||A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.|||3.31|0.98|0.0578
91676417|NCT04700280|183247914|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.69||0.617|TWO_SIDED|90.0|-6.2|3.4|||Mixed Models Analysis|||||3.4|-6.2|0.617
91676418|NCT04700280|183247916|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.62||0.3089|TWO_SIDED|90.0|-1.7|0.41|||Mixed Models Analysis|||Week 4||0.41|-1.70|0.3089
91676419|NCT04700280|183247916|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.71||0.2834|TWO_SIDED|90.0|-1.97|0.43|||Mixed Models Analysis|||Week 8||0.43|-1.97|0.2834
91676420|NCT04700280|183247916|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.95||0.7109|TWO_SIDED|90.0|-2.02|1.3|||Mixed Models Analysis|||Week 12||1.30|-2.02|0.7109
91676421|NCT04700280|183247917|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.81||0.859|TWO_SIDED|90.0|-3.6|2.9|||Mixed Models Analysis|||Week 4||2.9|-3.6|0.859
91676422|NCT04700280|183247917|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.46||0.837|TWO_SIDED|90.0|-3.8|4.8|||Mixed Models Analysis|||Week 8||4.8|-3.8|0.837
91676423|NCT01843348|183247919|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|Least square mean|-9.35|||<|0.0001|TWO_SIDED|95.0|-13.82|-4.88|||ANOVA|||The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin||-4.88|-13.82|<0.0001
91676424|NCT01843348|183247919|NON_INFERIORITY_OR_EQUIVALENCE|The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|Least squares mean|-5.56||||0.0067|TWO_SIDED|95.0|-9.56|-1.55||Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|ANOVA|||||-1.55|-9.56|0.0067
91676425|NCT01843348|183247920|SUPERIORITY_OR_OTHER||Point estimate|0.032|||||TWO_SIDED|95.0|-0.029|0.093||||||TAC+Certican - TAC+MPA - difference between groups||0.093|-0.029|
91676426|NCT01843348|183247920|SUPERIORITY_OR_OTHER||Point estimate|0.149|||||TWO_SIDED|95.0|0.076|0.221||||||CycA+Certican -Tac+MPA - difference between groups||0.221|0.076|
91486425|NCT01461980|182845394|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.82|1.0||||||PMB2948 \[B24\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.00|0.82|
91676427|NCT01843348|183247924|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.028|||<|0.001|TWO_SIDED|95.0|-0.032|0.087|||Pearson's chi-square test|||BPAR - treatment differences at Month 12||0.087|-0.032|< 0.001
91676428|NCT00257920|183247936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.009||0.67||95.0|-0.023|0.015||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<= 0.050 were considered statistically significant.|Mixed Models Analysis|||The null hypothesis was that there is no difference in the mean calcium absorption fraction between Zemplar Injection and Hectorol Injection. The power calculation applied to the primary efficacy analysis.||0.015|-0.023|0.670
91676429|NCT00257920|183247937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.009||0.573||95.0|-0.024|0.014||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<=0.050 were considered statistically significant.|ANOVA|||The null hypothesis was that there is no difference in mean calcium absorption between Zemplar and Hectorol. Approximately 42 subjects were to be randomized assuming 36 subjects would available in the per-protocol set. A sample size of 36 subjects has 80% power to detect a mean difference of -0.018 assuming the Zemplar group mean is 0.139, the Hectorol group mean is 0.157 and the STD is 0.037. The ANOVA model included effects for sequence, subject-within-sequence, period and treatment regimen.||0.014|-0.024|0.573
91676430|NCT01189500|183247954|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.69|||||TWO_SIDED|90.0|96.7|104.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||104.85|96.70|
91676431|NCT01189500|183247956|SUPERIORITY_OR_OTHER||ratio of adjusted means|99.44|||||TWO_SIDED|90.0|94.02|105.17|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||105.17|94.02|
91676432|NCT01189500|183247961|SUPERIORITY_OR_OTHER||ratio of adjusted means|92.04|||||TWO_SIDED|90.0|84.71|100.0|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||100.00|84.71|
91676433|NCT01189500|183247967|SUPERIORITY_OR_OTHER||ratio of adjusted means|112.07|||||TWO_SIDED|90.0|107.44|116.9|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||116.90|107.44|
91486426|NCT01890746|182845426|OTHER|Bioequivalence|Ratio of geometric means (%)|114.9|||||TWO_SIDED|90.0|99.5|132.7||||||||132.7|99.5|
91486427|NCT01890746|182845427|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|97.1|114.0||||||||114.0|97.1|
91676434|NCT01189500|183247972|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.6|||||TWO_SIDED|90.0|99.74|111.81|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||111.81|99.74|
91676435|NCT01189500|183247973|SUPERIORITY_OR_OTHER||ratio of adjusted means|108.47|||||TWO_SIDED|90.0|103.51|113.67|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||113.67|103.51|
91676436|NCT04764630|183247994|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.95||||0.002|ONE_SIDED|95.6|1.28|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 10-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (10, 12.5, and 15 min). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (1 every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.28|0.002
91692081|NCT03135548|183278806|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% confidence intervals (CI) are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
91692082|NCT03135548|183278806|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
91486428|NCT01890746|182845428|OTHER|Bioequivalence|Ratio of geometric means (%)|92.0|||||TWO_SIDED|90.0|76.8|110.2||||||||110.2|76.8|
91486429|NCT01890746|182845429|OTHER|Bioequivalence|Ratio of geometric means (%)|101.8|||||TWO_SIDED|90.0|92.9|111.7||||||||111.7|92.9|
91486430|NCT01890746|182845430|OTHER|Bioequivalence|Ratio of geometric means (%)|121.0|||||TWO_SIDED|90.0|102.5|142.8||||||||142.8|102.5|
91486431|NCT01890746|182845431|OTHER|Bioequivalence|Ratio of geometric means (%)|106.5|||||TWO_SIDED|90.0|95.0|119.4||||||||119.4|95.0|
91486432|NCT01890746|182845432|OTHER|Bioequivalence|Ratio of geometric means (%)|91.7|||||TWO_SIDED|90.0|76.5|110.0||||||||110.0|76.5|
91676437|NCT04764630|183247995|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.98||||0.018|ONE_SIDED|95.6|1.03|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.03|0.018
91676438|NCT04764630|183247996|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.69||||0.013|ONE_SIDED|95.6|1.06|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 4 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.06|0.013
91676439|NCT04764630|183247997|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.89||||0.1|TWO_SIDED|90.0|0.78|1.0|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.00|0.78|0.10
91676440|NCT04764630|183247997|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.77||||0.018|TWO_SIDED|90.0|0.65|0.92|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.92|0.65|0.018
91692083|NCT03135548|183278808|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.095|||||TWO_SIDED|95.0|-0.289|0.086|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.086|-0.289|
91692084|NCT03135548|183278808|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.115|||||TWO_SIDED|95.0|-0.116|0.348|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.348|-0.116|
91676441|NCT04764630|183247997|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.87||||0.12|TWO_SIDED|90.0|0.75|1.01|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.01|0.75|0.12
91486433|NCT01890746|182845433|OTHER|Bioequivalence|Ratio of geometric means (%)|101.4|||||TWO_SIDED|90.0|92.4|111.2||||||||111.2|92.4|
91676442|NCT04764630|183247998|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.83||||0.002|TWO_SIDED|90.0|0.76|0.91|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.91|0.76|0.002
91676443|NCT04764630|183247998|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.75|||<|0.001|TWO_SIDED|90.0|0.7|0.81|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.81|0.70|<0.001
91676444|NCT04764630|183247998|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.97|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.97|0.85|0.014
91692085|NCT03135548|183278809|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|7.24|||||TWO_SIDED|95.0|-20.01|34.48|||Student's t-distribution|CIs were based on Student's t-distribution.||||34.48|-20.01|
91486434|NCT01890746|182845434|OTHER|Bioequivalence|Ratio of geometric means (%)|120.0|||||TWO_SIDED|90.0|100.7|142.6||||||||142.6|100.7|
91486435|NCT01890746|182845435|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|93.6|118.3||||||||118.3|93.6|
91486436|NCT01890746|182845436|OTHER|Bioequivalence|Ratio of geometric means (%)|80.4|||||TWO_SIDED|90.0|57.2|113.0||||||||113.0|57.2|
91486437|NCT01890746|182845437|OTHER|Bioequivalence|Ratio of geometric means (%)|106.3|||||TWO_SIDED|90.0|87.6|129.0||||||||129.0|87.6|
91486438|NCT01890746|182845438|OTHER|Bioequivalence|Ratio of geometric means (%)|127.1|||||TWO_SIDED|90.0|84.2|191.9||||||||191.9|84.2|
91692086|NCT03135548|183278809|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-28.35|16.7|||Student's t-distribution|CIs were based on Student's t-distribution.||||16.70|-28.35|
91692087|NCT03135548|183278810|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.143|||||TWO_SIDED|95.0|-0.346|0.049|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.049|-0.346|
91692088|NCT03135548|183278810|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.015|||||TWO_SIDED|95.0|-0.213|0.252|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.252|-0.213|
91692089|NCT05022667|183278864|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
91692090|NCT05022667|183278865|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
91692091|NCT05022667|183278866|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.2
91692092|NCT05022667|183278867|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
91692093|NCT05022667|183278868|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
91692094|NCT05022667|183278870|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||.3
91486439|NCT01890746|182845439|OTHER|Bioequivalence|Ratio of geometric means (%)|110.5|||||TWO_SIDED|90.0|83.9|145.7||||||||145.7|83.9|
91486440|NCT01890746|182845440|OTHER|Bioequivalence|Ratio of geometric means (%)|286.4|||||TWO_SIDED|90.0|90.1|910.7||||||||910.7|90.1|
91486441|NCT01890746|182845441|OTHER|Bioequivalence|Ratio of geometric means (%)|202.3|||||TWO_SIDED|90.0|131.3|311.8||||||||311.8|131.3|
91486442|NCT01890746|182845443|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.7461|TWO_SIDED|95.0|0.28|2.48|||Log Rank|||||2.48|0.28|0.7461
91486443|NCT01890746|182845444|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6175|TWO_SIDED|95.0|0.74|1.63|||Log Rank|||||1.63|0.74|0.6175
91486444|NCT01890746|182845445|SUPERIORITY||Odds Ratio (OR)|0.5281||||0.3224|TWO_SIDED|95.0|0.1084|2.2086|||Cochran-Mantel-Haenszel|||||2.2086|0.1084|0.3224
91486445|NCT01890746|182845447|SUPERIORITY|||||||0.6942|||||||Wilcoxon rank-sum test|||||||0.6942
91486446|NCT01890746|182845448|SUPERIORITY||Odds Ratio (OR)|1.1151||||0.7397|TWO_SIDED|95.0|0.5585|2.229|||Cochran-Mantel-Haenszel|||||2.2290|0.5585|0.7397
91486447|NCT01890746|182845449|SUPERIORITY||Hazard Ratio (HR)|2.46||||0.0781|TWO_SIDED|95.0|0.95|6.38|||Log Rank|||||6.38|0.95|0.0781
91676445|NCT04764630|183247999|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.82||||0.001|TWO_SIDED|90.0|0.75|0.89|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.89|0.75|0.001
91676446|NCT04764630|183247999|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.74|||<|0.001|TWO_SIDED|90.0|0.69|0.8|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.80|0.69|<0.001
91676447|NCT04764630|183247999|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.96|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.96|0.85|0.014
91676448|NCT01144364|183248020|SUPERIORITY_OR_OTHER|||||||0.254|||||||Log Rank|||Difference between treatment arms||||0.254
91676449|NCT01144364|183248022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.105|TWO_SIDED|95.0|0.31|1.12||Overall DFS|Cox proportional-hazards|Adjusted for randomization stratum and the known prognostic factors.||||1.12|0.31|0.105
91486448|NCT01890746|182845453|SUPERIORITY||Odds Ratio (OR)|0.8749||||0.7122|TWO_SIDED|95.0|0.4023|1.8943|||Cochran-Mantel-Haenszel|||||1.8943|0.4023|0.7122
91486449|NCT01890746|182845454|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.0688|TWO_SIDED|95.0|0.96|2.47|||Log Rank|||||2.47|0.96|0.0688
91676450|NCT01144364|183248023|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
91676451|NCT01144364|183248024|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
91676452|NCT01144364|183248026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.079|TWO_SIDED|95.0|0.38|1.05|||Cox proportional-hazards|||Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.||1.05|0.38|0.079
91676453|NCT01144364|183248029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.103|TWO_SIDED|95.0|0.4|1.09||Univariate analysis|Regression, Cox|Cox model stratified for the stratification groups.||||1.09|0.40|0.103
91676454|NCT01144364|183248029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.071|TWO_SIDED|95.0|0.37|1.04||Multivariate analysis|Regression, Cox|Adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, FL International prognostic index (FLIPI) score.||||1.04|0.37|0.071
91676455|NCT01144364|183248030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.084|TWO_SIDED|95.0|0.39|1.06||Univariate analysis|Fine and Gray model|Fine and Gray model stratified for the stratification groups.||||1.06|0.39|0.084
91676456|NCT01144364|183248030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.052|TWO_SIDED|95.0|0.38|1.0|||Fine and Gray model|Fine and Gray model adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, and FLIPI score||||1.00|0.38|0.052
91692095|NCT03521154|183278873|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.24|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.24|0.10|<0.001
91692096|NCT03521154|183278874|SUPERIORITY||Hazard Ratio (HR)|0.17|||||TWO_SIDED|95.0|0.1|0.29|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in Ex19Del positive patients||0.29|0.10|
91486450|NCT00100178|182845456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.47
91486451|NCT00631696|182845457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A non-inferiority margin of 20% was used to test the hypothesis. The null hypothesis is that the difference (PGB - PBO) in the proportion of participants with ≥50% reduction in sperm concentration is ≥20% and the alternative hypothesis is that the difference in proportion of participant with ≥50% reduction in sperm concentration is \<20%.|percentage difference|6.0|||||TWO_SIDED|95.0|-2.29|14.3|||Confidence Interval Approach||The confidence interval was based on asymptotic normal distribution.|Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not \>20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide \>90% power to show NI of PGB to PBO.||14.30|-2.29|
91486452|NCT00631696|182845458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12||||0.3462|TWO_SIDED|95.0|-0.385|0.136||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.136|-0.385|0.3462
91486453|NCT00631696|182845459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13||||0.3652|TWO_SIDED|95.0|-0.42|0.156||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.156|-0.420|0.3652
91486454|NCT00631696|182845460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.1204|TWO_SIDED|95.0|-0.464|0.054||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.054|-0.464|0.1204
91486455|NCT00631696|182845461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|24.65||||0.2875|TWO_SIDED|95.0|-20.999|70.302||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||70.302|-20.999|0.2875
91642793|NCT02255422|183177713|SUPERIORITY||LS mean difference (net)|-33.448|STANDARD_ERROR_OF_MEAN|11.6473||0.006|TWO_SIDED|95.0|-56.855|-10.042||P-value comparison is for difference in change in six minute walk distance from baseline within each dosage group relative to placebo. Statistical significance defined as p\<0.05.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 4||-10.042|-56.855|0.0060
91642794|NCT02255422|183177713|SUPERIORITY||LS mean difference (net)|-3.963|STANDARD_ERROR_OF_MEAN|11.53||0.7325|TWO_SIDED|95.0|-27.133|19.207||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 8||19.207|-27.133|0.7325
91642795|NCT02255422|183177713|SUPERIORITY||LS mean difference (net)|-18.594|STANDARD_ERROR_OF_MEAN|15.0004||0.221|TWO_SIDED|95.0|-48.739|11.55||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 12||11.550|-48.739|0.2210
91642796|NCT03222570|183177714|SUPERIORITY||Estimated mean difference|-0.88||||0.76|TWO_SIDED|95.0|-6.56|4.7|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||4.7|-6.56|0.76
91642797|NCT03222570|183177715|SUPERIORITY||Estimated mean difference|-2.52||||0.32|TWO_SIDED|95.0|-7.42|2.3|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||2.3|-7.42|0.32
91642798|NCT03179462|183177726|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91642799|NCT04410978|183177765|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.061||||0.6691|TWO_SIDED|95.0|0.808|1.393||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.393|0.808|0.6691
91642800|NCT04410978|183177766|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.85||||0.4888|TWO_SIDED|95.0|0.565|1.278||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.278|0.565|0.4888
91642801|NCT04410978|183177767|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.819||||0.2991|TWO_SIDED|95.0|0.582|1.151||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.151|0.582|0.2991
91642802|NCT04410978|183177768|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.084||||0.4575|TWO_SIDED|95.0|0.876|1.342|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.342|0.876|0.4575
91692097|NCT03521154|183278874|SUPERIORITY||Hazard Ratio (HR)|0.32||||||95.0|0.19|0.56|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in L858R positive patients||0.56|0.19|
91692098|NCT03521154|183278875|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.15|0.34|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|Negative at screening||0.34|0.15|
91692099|NCT03521154|183278876|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.09|<0.001
91486456|NCT00631696|182845462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.93||||0.1699|TWO_SIDED|95.0|-14.292|80.158||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||80.158|-14.292|0.1699
91486457|NCT00631696|182845463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.12||||0.7958|TWO_SIDED|95.0|-52.804|40.558||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||40.558|-52.804|0.7958
91692100|NCT03521154|183278878|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.53|TWO_SIDED|95.0|0.42|1.56|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.56|0.42|0.530
91692101|NCT03521154|183278879|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.54|5.08|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||5.08|1.54|<0.001
91692102|NCT03521154|183278881|SUPERIORITY||Odds Ratio (OR)|2.06||||0.069|TWO_SIDED|95.0|0.94|4.47|||Regression, Logistic||An odds ratio \> 1 favours osimertinib.|||4.47|0.94|0.069
91692103|NCT03521154|183278884|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.38|0.11|<0.001
91692104|NCT03521154|183278885|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.14|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.14|<0.001
91692105|NCT03521154|183278886|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.21|0.08|<0.001
91692106|NCT03521154|183278887|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.022|TWO_SIDED|95.0|0.28|0.91|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.91|0.28|0.022
91692107|NCT03521154|183278888|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.088|TWO_SIDED|95.0|0.35|1.08|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.08|0.35|0.088
91692108|NCT04632927|183278897|OTHER||Odds Ratio (OR)|3.647||||0.002|TWO_SIDED|95.0|1.601|8.311|||Regression, Logistic|The OR was calculated using a logistic regression model with treatment group, baseline HAQ-DI and strata (body weight) as independent variables||||8.311|1.601|0.002
91692109|NCT04795466|183278922|SUPERIORITY||Least square mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.1442||0.6386|TWO_SIDED|90.0|-0.178|0.316|||Mixed Models Analysis|||NTB Total z-score - day 171||0.316|-0.178|0.6386
91692110|NCT04795466|183278923|SUPERIORITY||Least squares mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.1739||0.9917|TWO_SIDED|90.0|-0.3|0.296|||Mixed Models Analysis|||Memory function - day 171||0.296|-0.300|0.9917
91692111|NCT04795466|183278924|SUPERIORITY||least squares mean difference|0.186|STANDARD_ERROR_OF_MEAN|0.1958||0.351|TWO_SIDED|90.0|-0.148|0.52|||Mixed Models Analysis|||Executive function- day 171||0.520|-0.148|0.3510
91692112|NCT04795466|183278925|SUPERIORITY||Repeated measures analysis|-0.49|STANDARD_ERROR_OF_MEAN|1.8||0.787|TWO_SIDED|90.0|-3.56|2.58|||Mixed Models Analysis|||DSST - day 171||2.58|-3.56|0.7870
91692113|NCT02612623|183278985|OTHER||LSM Difference|-0.56|||||TWO_SIDED|95.0|-2.08|0.96|||||Gefapixant minus Placebo|Least squares mean (LSM) difference: Mixed effect repeated measures model (MMRM) uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.96|-2.08|
91692114|NCT02612623|183278985|OTHER||LSM Difference|-0.71|||||TWO_SIDED|95.0|-2.34|0.92|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.92|-2.34|
91692115|NCT02612623|183278985|OTHER||LSM Difference|-1.35|||||TWO_SIDED|95.0|-2.99|0.3|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.30|-2.99|
91692116|NCT02612623|183278985|OTHER||Percentage Change|-42.6|||||TWO_SIDED|95.0|-87.5|162.3|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||162.3|-87.5|
91692117|NCT02612623|183278985|OTHER||Percentage Change|-50.8|||||TWO_SIDED|95.0|-90.3|151.1|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||151.1|-90.3|
91692118|NCT02612623|183278985|OTHER||Percentage Change|-74.0|||||TWO_SIDED|95.0|-95.0|34.7|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||34.7|-95.0|
91692119|NCT02535026|183279024|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||ER status association with age groups||||0.280
91692120|NCT02535026|183279025|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||ER status association with nuclear grade.||||<0.001
91692121|NCT02535026|183279026|SUPERIORITY_OR_OTHER||||||=|0.03|||||||Chi-squared|||ER status association with lymphovascular invasion.||||=0.03
91692122|NCT02535026|183279027|SUPERIORITY_OR_OTHER||||||=|0.004|||||||Chi-squared|||PR status association with age groups||||=0.004
91692123|NCT02535026|183279028|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||PR status association with nuclear grade.||||<0.001
91692124|NCT02535026|183279029|SUPERIORITY_OR_OTHER||||||=|0.025|||||||ANOVA|||PR status association with lymphovascular invasion.||||=0.025
91692125|NCT02535026|183279030|SUPERIORITY_OR_OTHER||||||=|0.056|||||||ANOVA|||HER2 status association with age groups.||||=0.056
91692126|NCT02535026|183279031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||HER2 status association with nuclear grade.||||<0.001
91692127|NCT02535026|183279032|SUPERIORITY_OR_OTHER||||||=|0.129|||||||Chi-squared|||||||=0.129
91692128|NCT02535026|183279033|SUPERIORITY_OR_OTHER||||||=|0.003|||||||ANOVA|||Breast cancer phenotypes association with age groups.||||=0.003
91692129|NCT02535026|183279034|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Breast cancer phenotypes association with nuclear grades.||||<0.001
91717048|NCT01687218|183326480|OTHER||Slope|-1.82|||<|0.001|TWO_SIDED|95.0|-1.95|-1.7|||Mixed Models Analysis||This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.70|-1.95|<0.001
91486458|NCT00631696|182845464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08||||0.4094|TWO_SIDED|95.0|-3.645|1.494||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.494|-3.645|0.4094
91676457|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-3.0|5.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-3.0|
91676458|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|2.66|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-1.4|6.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.8|-1.4|
91676459|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-1.1|7.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.1|-1.1|
91676460|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|2.53|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-1.6|6.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.6|
91676461|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.0789|||TWO_SIDED|95.0|-2.4|5.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.8|-2.4|
91676462|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
91717049|NCT01687218|183326481|SUPERIORITY||Slope|0.66|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.83|0.49|<0.001
91717050|NCT01687218|183326481|SUPERIORITY||Slope|-0.16||||0.31|TWO_SIDED|95.0|-0.46|0.15|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.15|-0.46|0.31
91486459|NCT00631696|182845465|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.9064|TWO_SIDED|95.0|-2.649|2.352||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||2.352|-2.649|0.9064
91486460|NCT00631696|182845466|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86||||0.4666|TWO_SIDED|95.0|-3.207|1.477||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.477|-3.207|0.4666
91676463|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-7.2|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-7.2|
91676464|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-5.4|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-5.4|
91676465|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
91676466|NCT02037165|183248031|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.68|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-6.7|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-6.7|
91676467|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|1.58|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-2.4|5.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.6|-2.4|
91676468|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-1.4|6.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.4|
91676469|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.2|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-4.2|
91676470|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.0276|||TWO_SIDED|95.0|-2.8|5.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-2.8|
91676471|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.6|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-4.6|
91486461|NCT03198078|182845472|SUPERIORITY||LS mean difference|-5.33||||0.0136|TWO_SIDED|95.0|-9.55|-1.1||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-1.10|-9.55|0.0136
91676472|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.88|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-6.9|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-6.9|
91676473|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-3.6|4.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-3.6|
91676474|NCT02037165|183248031|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-5.0|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-5.0|
91676475|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.6|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-4.6|
91676476|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.87|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-6.5|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-6.5|
91676477|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.08|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-6.7|0.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-6.7|
91676478|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.63|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-5.3|2.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.0|-5.3|
91676479|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.8554|||TWO_SIDED|95.0|-3.5|3.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-3.5|
91486462|NCT03198078|182845472|SUPERIORITY||LS mean difference|-6.53||||0.0032|TWO_SIDED|95.0|-10.8|-2.21||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-2.21|-10.8|0.0032
91527505|NCT04534114|182930303|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.91||||0.909|TWO_SIDED|95.0|0.18|4.52|||Log Rank|||||4.52|0.18|0.909
91676480|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-3.0|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-3.0|
91676481|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-4.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.8|
91676482|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.34|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-5.0|2.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-5.0|
91676483|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.84|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.5|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-4.5|
91676484|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-4.7|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.7|
91676485|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-7.6|-0.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.4|-7.6|
91676486|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.43|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-6.0|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-6.0|
91676487|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-4.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-4.9|
91692130|NCT02535026|183279035|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||phenotypes of breast cancer association with lymphovascular invasion.||||=0.001
91486463|NCT03198078|182845473|SUPERIORITY||LS mean difference|-1.44||||0.0205|TWO_SIDED|95.0|-2.65|-0.22||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.22|-2.65|0.0205
91692131|NCT02535026|183279036|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with ER status.||||<0.001
91692132|NCT02535026|183279037|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Phenotypes of breast cancer association with PR status.||||<0.001
91692133|NCT02535026|183279038|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with HER2 status.||||<0.001
91692134|NCT01671007|183279040|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.08|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.08|0.64|
91642803|NCT04410978|183177769|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.86||||0.0001|TWO_SIDED|95.0|1.358|2.548|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.548|1.358|0.0001
91642804|NCT04410978|183177770|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|0.035||||0.432|TWO_SIDED|95.0|-0.053|0.124|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.124|-0.053|0.4320
91642805|NCT04410978|183177771|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|1.873||||0.0675|TWO_SIDED|95.0|-0.135|3.88|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||3.880|-0.135|0.0675
91642806|NCT04410978|183177772|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.831||||0.3594|TWO_SIDED|95.0|0.554|1.245||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.245|0.554|0.3594
91642807|NCT04410978|183177773|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.196||||0.0002|TWO_SIDED|95.0|0.093|0.298|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.298|0.093|0.0002
91642808|NCT05153629|183177782|OTHER|||||||0.93||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of back pain.||||0.93
91642809|NCT05153629|183177782|OTHER|||||||0.76||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of abdominal/groin pain.||||0.76
91642810|NCT05153629|183177782|OTHER|||||||0.56||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain frequency.||||0.56
91642811|NCT05153629|183177782|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of nausea intensity.||||0.26
91642812|NCT05153629|183177783|OTHER|||||||0.55||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in back pain.||||0.55
91642813|NCT05153629|183177783|OTHER|||||||0.28||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in abdominal/groin pain.||||0.28
91642814|NCT05153629|183177783|OTHER|||||||0.39||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in pain frequency.||||0.39
91642815|NCT05153629|183177783|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in nausea intensity.||||0.26
91642816|NCT05153629|183177784|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
91642817|NCT05153629|183177785|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
91642818|NCT05153629|183177786|OTHER|||||||0.8||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall USDT score.||||0.80
91642819|NCT05153629|183177786|OTHER|||||||0.72||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of urinary symptoms.||||0.72
91642820|NCT05153629|183177786|OTHER|||||||0.45||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain.||||0.45
91642821|NCT05153629|183177786|OTHER|||||||0.42||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of daily life.||||0.42
91642822|NCT05153629|183177786|OTHER|||||||0.36||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of sexual life.||||0.36
91642823|NCT05153629|183177786|OTHER|||||||0.49||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of medical care/analgesic use.||||0.49
91642824|NCT05153629|183177786|OTHER|||||||0.88||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall quality of life.||||0.88
91642825|NCT04089566|183177791|SUPERIORITY|The Analysis of Covariance (ANCOVA) model used rank score as response, treatment as fixed effect and disease duration at screening, baseline Hammersmith Infant Neurological Examination (HINE) Section 2 (HINE 2), baseline CHOP INTEND total score as covariates.|Least square (LS) mean difference|26.06|STANDARD_ERROR_OF_MEAN|4.141|<|0.0001|TWO_SIDED|95.0|17.941|34.172|||ANCOVA|||||34.172|17.941|< 0.0001
91642826|NCT04089566|183177814|SUPERIORITY||Difference of percentages|58.0|||<|0.0001|TWO_SIDED|95.0|39.46|71.81|||Fisher Exact||Exact unconditional confidence interval|||71.81|39.46|<0.0001
91676488|NCT02037165|183248032|SUPERIORITY_OR_OTHER||Slope|-1.72|STANDARD_ERROR_OF_MEAN|1.825|||TWO_SIDED|95.0|-5.3|1.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-5.3|
91676489|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-3.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-3.8|
91676490|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-5.0|2.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-5.0|
91676491|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.65|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-6.2|0.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-6.2|
91676492|NCT02037165|183248032|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-3.9|3.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.3|-3.9|
91676493|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.8|
91676494|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|2.18|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-0.5|4.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.9|-0.5|
91676495|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|1.01|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.7|3.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.7|
91486464|NCT03198078|182845473|SUPERIORITY||LS mean difference|-2.15||||0.0008|TWO_SIDED|95.0|-3.4|-0.91||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.91|-3.40|0.0008
91692135|NCT01671007|183279041|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.7|1.27|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.27|0.70|
91486465|NCT03198078|182845473|SUPERIORITY||LS mean difference|-0.88||||0.136|TWO_SIDED|95.0|-2.04|0.28||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.28|-2.04|0.1360
91676496|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.4|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-1.4|
91486466|NCT03198078|182845473|SUPERIORITY||LS mean difference|-0.95||||0.1158|TWO_SIDED|95.0|-2.14|0.24||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.24|-2.14|0.1158
91676497|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.0|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-2.0|
91676498|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|0.36|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.3|3.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.3|
91676499|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.3|1.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-4.3|
91676500|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.51|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-4.2|
91676501|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-3.5|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-3.5|
91676502|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-4.2|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-4.2|
91486467|NCT03198078|182845474|SUPERIORITY||Ratio of Response Rate|1.55||||0.0111|TWO_SIDED|95.0|1.09|2.2|||Cochran-Mantel-Haenszel|P-value was analyzed by Cochran-Mantel-Haenszel (CMH) general association test controlling for (pooled) centers.||||2.20|1.09|0.0111
91486468|NCT03198078|182845474|SUPERIORITY||Ratio of Response Rate|1.51||||0.0224|TWO_SIDED|95.0|1.06|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.06|0.0224
91486469|NCT03198078|182845475|SUPERIORITY||Ratio of Remission Rate|1.18||||0.4415|TWO_SIDED|95.0|0.77|1.81|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||1.81|0.77|0.4415
91486470|NCT03198078|182845475|SUPERIORITY||Ratio of Remission Rate|1.48||||0.0472|TWO_SIDED|95.0|1.01|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.01|0.0472
91527506|NCT04765735|182930319|SUPERIORITY||||||<|0.001||||||"It is hypothesized that the proportion of subjects with a reduction in overstimulation sensation during CL compared to OL period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test|||||||<0.001
91486471|NCT03198078|182845476|SUPERIORITY||LS mean difference|2.48||||0.0854|TWO_SIDED|95.0|-0.35|5.31||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||5.31|-0.35|0.0854
91486472|NCT03198078|182845476|SUPERIORITY||LS mean difference|3.99||||0.0072|TWO_SIDED|95.0|1.09|6.88||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||6.88|1.09|0.0072
91676503|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|1.07|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.5|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.5|
91676504|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.8|
91676505|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.32|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-3.9|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.9|
91676506|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.0|3.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.2|-2.0|
91676507|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.6|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.6|
91676508|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-4.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.7|
91676509|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.2|3.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.2|
91692136|NCT01671007|183279042|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.06|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.06|0.43|
91486473|NCT03198078|182845477|SUPERIORITY||LS mean difference|-0.11||||0.3589|TWO_SIDED|95.0|-0.36|0.13||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.13|-0.36|0.3589
91486474|NCT03198078|182845477|SUPERIORITY||LS mean difference|-0.2||||0.1118|TWO_SIDED|95.0|-0.45|0.05||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.05|-0.45|0.1118
91486475|NCT03198078|182845478|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.0287|TWO_SIDED|95.0|-0.56|-0.03|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.03|-0.56|0.0287
91486476|NCT03198078|182845478|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0184|TWO_SIDED|95.0|-0.62|-0.06|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.06|-0.62|0.0184
91676510|NCT02037165|183248033|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-2.9|
91676511|NCT02037165|183248034|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.4|1.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.4|
91676512|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.4|0.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.4|
91676513|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.1|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-4.1|
91676514|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
91676515|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-2.1|
91676516|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.1|
91676517|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
91692137|NCT01671007|183279043|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.43|1.09|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.09|0.43|
91486477|NCT03198078|182845489|SUPERIORITY||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.24|0.39|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.39|-0.24|
91642827|NCT04089566|183177815|SUPERIORITY||LS mean difference|26.67|STANDARD_ERROR_OF_MEAN|4.009|<|0.0001|TWO_SIDED|95.0|18.812|34.526||ANCOVA model was used treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||34.526|18.812|<0.0001
91642828|NCT04089566|183177816|SUPERIORITY||LS geometric mean ratio|0.08|||<|0.0001||||||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||||<0.0001
91642829|NCT04089566|183177817|SUPERIORITY||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|5.251|=|0.8484|TWO_SIDED|95.0|-9.29|11.299||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||11.299|-9.29|=0.8484
91486478|NCT03198078|182845489|SUPERIORITY||LS mean difference|0.18|||||TWO_SIDED|95.0|-0.14|0.51|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.51|-0.14|
91642830|NCT04089566|183177818|SUPERIORITY||LS mean difference|6.12|STANDARD_ERROR_OF_MEAN|4.497|=|0.1734|TWO_SIDED|95.0|-2.693|14.939||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||14.939|-2.693|=0.1734
91642831|NCT04089566|183177819|SUPERIORITY||LS geometric mean ratio|0.51|||=|0.002|TWO_SIDED|95.0|0.33|0.78||ANCOVA model was used with treatment as a fixed effect and adjustment for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||0.78|0.33|=0.002
91642832|NCT04089566|183177862|SUPERIORITY||LS geometric mean ratio|0.86|||=|0.3785|TWO_SIDED|95.0|0.62|1.2||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log CSF NF-L and baseline CHOP INTEND total score.|ANCOVA|||||1.2|0.62|=0.3785
91642833|NCT04938687|183177956|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
91642834|NCT04938687|183177956|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
91642835|NCT04938687|183177956|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||0.037
91692138|NCT01671007|183279047|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.88|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.88|0.38|
91486479|NCT03198078|182845490|SUPERIORITY||LS mean difference|-0.06|||||TWO_SIDED|95.0|-0.3|0.18|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.18|-0.30|
91486480|NCT03198078|182845490|SUPERIORITY||LS mean difference|0.11|||||TWO_SIDED|95.0|-0.13|0.36|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.36|-0.13|
91486481|NCT03198078|182845491|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.09|-0.08|
91527507|NCT02875834|182930320|OTHER||Mean Difference (Final Values)|0.904|||<|0.001|TWO_SIDED|95.0|0.876|0.933|||Mixed Models Analysis|||Results derived from a mixed effects model of log-transformed S-K levels. Fixed effects are: treatment group; visit; treatment-by-visit interaction; baseline S-K values (OLP and RTP); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses. Patient is a random effect. p-values given are for differences of LSMEANS. The back-transformation is to the original scale of the S-K measurement.||0.933|0.876|<0.001
91642836|NCT04938687|183177957|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
91642837|NCT04938687|183177957|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91642838|NCT04938687|183177957|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|||||||0.069
91642839|NCT04938687|183177958|SUPERIORITY|||||||0.92|||||||ANOVA|||||||0.92
91642840|NCT04938687|183177958|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||0.053
91642841|NCT04938687|183177958|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|||||||0.069
91642842|NCT04938687|183177959|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
91642843|NCT04938687|183177959|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91642844|NCT04938687|183177959|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||||||0.073
91642845|NCT04938687|183177960|SUPERIORITY|||||||0.93|||||||ANOVA|||||||0.93
91642846|NCT04938687|183177960|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91642847|NCT04938687|183177960|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91642848|NCT04938687|183177961|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
91642849|NCT04938687|183177961|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||0.038
91642850|NCT04938687|183177961|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91642851|NCT04938687|183177962|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91642852|NCT04938687|183177962|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91642853|NCT04938687|183177962|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91642854|NCT04938687|183177965|SUPERIORITY|||||||0.42|||||||ANOVA|||||||0.42
91642855|NCT04938687|183177965|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91642856|NCT04938687|183177965|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91642857|NCT02087865|183177974|SUPERIORITY||Mean Difference (Final Values)|-8.25|STANDARD_ERROR_OF_MEAN|7.59||0.273|TWO_SIDED|95.0|-23.12|6.63|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||6.63|-23.12|0.273
91642858|NCT02087865|183177975|SUPERIORITY||Mean Difference (Final Values)|-13.41|STANDARD_ERROR_OF_MEAN|3.92||0.001|TWO_SIDED|95.0|-21.09|-5.73|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-5.73|-21.09|0.001
91642859|NCT02087865|183177976|SUPERIORITY||Median Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|5.48||0.115|TWO_SIDED|95.0|-19.33|2.14|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||2.14|-19.33|0.115
91717051|NCT01687218|183326482|SUPERIORITY||Slope|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.||0.50|0.10|0.004
91717052|NCT01687218|183326482|SUPERIORITY||Slope|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.47|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-0.47|-0.92|<0.001
91717053|NCT01687218|183326483|SUPERIORITY||Slope|-2.66|||<|0.001|TWO_SIDED|95.0|-2.82|-2.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.50|-2.82|<0.001
91717054|NCT01687218|183326483|SUPERIORITY||Slope|-2.65|||<|0.001|TWO_SIDED|95.0|-2.81|-2.49|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.49|-2.81|<0.001
91717055|NCT01687218|183326484|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
91717056|NCT01687218|183326484|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
91717057|NCT01687218|183326485|SUPERIORITY||Slope|-2.0|||<|0.001|TWO_SIDED|95.0|-2.16|-1.84|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.84|-2.16|<0.001
91717058|NCT01687218|183326485|SUPERIORITY||Slope|-1.9|||<|0.001|TWO_SIDED|95.0|-2.07|-1.74|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.74|-2.07|<0.001
91486482|NCT03198078|182845491|SUPERIORITY||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.14|-0.04|
91717059|NCT01687218|183326486|SUPERIORITY||Slope|0.54|||<|0.001|TWO_SIDED|95.0|0.35|0.72|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.72|0.35|<0.001
91717060|NCT01687218|183326486|SUPERIORITY||Slope|0.01||||0.92|TWO_SIDED|95.0|-0.28|0.31|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.31|-0.28|0.92
91486483|NCT02607930|182845513|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-0.6|||||TWO_SIDED|95.002|-4.8|3.6|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.6|-4.8|
91486484|NCT02607930|182845513|SUPERIORITY|||||||0.78|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.78
91486485|NCT02607930|182845514|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-6.9|3.1|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.1|-6.9|
91486486|NCT02607930|182845514|OTHER|||||||0.45|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.45
91486487|NCT02607930|182845515|OTHER||Difference in Percentages|-2.6|||||TWO_SIDED|95.0|-8.5|3.4|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.4|-8.5|
91486488|NCT02607930|182845515|OTHER|||||||0.39|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.39
91486489|NCT02607930|182845516|OTHER||Difference in Percentages|0.4|||||TWO_SIDED|95.0|-4.8|5.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.6|-4.8|
91676518|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
91676519|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
91676520|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.7|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-3.7|
91676521|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.3|0.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.3|
91676522|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.16|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
91692272|NCT00333983|183279568|SUPERIORITY_OR_OTHER|||||||0.025||||||P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.|Mixed Models Analysis|||An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.||||.025
91486490|NCT02607930|182845516|OTHER|||||||0.87|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.87
91486491|NCT02607930|182845517|OTHER||Difference in Percentages|-1.2|||||TWO_SIDED|95.0|-6.9|4.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||4.6|-6.9|
91486492|NCT02607930|182845517|OTHER|||||||0.69|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.69
91486493|NCT02607930|182845518|OTHER||Difference in Percentages|-4.2|||||TWO_SIDED|95.0|-10.5|2.1|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||2.1|-10.5|
91486494|NCT02607930|182845518|OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.19
91486495|NCT02607930|182845519|OTHER||Difference in LSM|-0.03||||0.48|TWO_SIDED|95.0|-0.12|0.06|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.06|-0.12|0.48
91486496|NCT02607930|182845520|OTHER||Difference in LSM|0.0||||0.99|TWO_SIDED|95.0|-0.09|0.09|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.09|-0.09|0.99
91486497|NCT02607930|182845521|OTHER||Difference in LSM|0.01||||0.88|TWO_SIDED|95.0|-0.08|0.1|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.10|-0.08|0.88
91486498|NCT02607930|182845522|OTHER||Difference in LSM|6.0||||0.69|TWO_SIDED|95.0|-24.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-24|0.69
91676523|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.3|
91676524|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.1|1.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-3.1|
91676525|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.0|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.0|
91676526|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
91692273|NCT03656068|183279580|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.003||||0.0039|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0039
91486499|NCT02607930|182845523|OTHER||Difference in LSM|-1.0||||0.94|TWO_SIDED|95.0|-39.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-39|0.94
91486500|NCT02607930|182845524|OTHER||Difference in LSM|-20.0||||0.3|TWO_SIDED|95.0|-59.0|18.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||18|-59|0.30
91486501|NCT02607930|182845525|OTHER||Difference in LSM|0.346||||0.092|TWO_SIDED|95.0|-0.057|0.748|||ANOVA|||||0.748|-0.057|0.092
91692274|NCT03656068|183279581|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|10.0||||0.0026|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0026
91486502|NCT02607930|182845526|OTHER||Difference in LSM|0.135||||0.59|TWO_SIDED|95.0|-0.356|0.625|||ANOVA|||||0.625|-0.356|0.59
91486503|NCT02607930|182845527|OTHER||Difference in LSM|0.271||||0.39|TWO_SIDED|95.0|-0.351|0.893|||ANOVA|||||0.893|-0.351|0.39
91486504|NCT02607930|182845528|OTHER||Difference in LSM|-0.221||||0.41|TWO_SIDED|95.0|-0.741|0.3|||ANOVA|||||0.300|-0.741|0.41
91486505|NCT02607930|182845529|OTHER||Difference in LSM|-0.485||||0.14|TWO_SIDED|95.0|-1.126|0.155|||ANOVA|||||0.155|-1.126|0.14
91486506|NCT02607930|182845530|OTHER||Difference in LSM|-0.406||||0.26|TWO_SIDED|95.0|-1.119|0.307|||ANOVA|||||0.307|-1.119|0.26
91527508|NCT02875834|182930320|OTHER||Mean Difference (Final Values)|0.823|||<|0.001|TWO_SIDED|95.0|0.797|0.85|||Mixed Models Analysis|||||0.850|0.797|<0.001
91692275|NCT03656068|183279582|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.002||||0.5555|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.5555
91692276|NCT03656068|183279583|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|1.72||||0.3778|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.3778
91692277|NCT03656068|183279584|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.1||||0.4638|TWO_SIDED|95.0|-31.0|14.8||p-value for testing mean = 0|t-test, 2 sided|||||14.8|-31.0|0.4638
91692278|NCT03656068|183279585|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.65||||0.6532|TWO_SIDED|95.0|-9.26|5.97||p-value for testing mean = 0|t-test, 2 sided|||||5.97|-9.26|0.6532
91692279|NCT03656068|183279586|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.7254|TWO_SIDED|95.0|-1.86|2.61||p-value for testing mean = 0|t-test, 2 sided|||||2.61|-1.86|0.7254
91692280|NCT03656068|183279587|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.77||||0.3772|TWO_SIDED|95.0|-11.7|29.25||p-value for testing mean = 0|t-test, 2 sided|||||29.25|-11.70|0.3772
91692281|NCT03656068|183279588|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.5799|TWO_SIDED|95.0|-0.56|0.33||p-value for testing mean = 0|t-test, 2 sided|||||0.33|-0.56|0.5799
91692282|NCT03656068|183279589|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.89||||0.7088|TWO_SIDED|95.0|-12.65|8.87||p-value for testing mean = 0|t-test, 2 sided|||||8.87|-12.65|0.7088
91692283|NCT03656068|183279590|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.35||||0.0609|TWO_SIDED|95.0|-0.72|0.02||p-value for testing mean = 0|t-test, 2 sided|||||0.02|-0.72|0.0609
91486507|NCT03711266|182845576|OTHER||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|18.5|44.3|||t-test, 2 sided|||Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).||44.3|18.5|<.001
91486508|NCT00749515|182845625|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91486509|NCT00749515|182845626|OTHER|||||||0.275|||||||t-test, 2 sided|||||||.275
91486510|NCT00749515|182845627|OTHER|||||||0.178|||||||t-test, 2 sided|||||||.178
91486511|NCT00749515|182845628|OTHER|||||||0.062|||||||t-test, 2 sided|||||||.062
91676527|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.1|0.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-4.1|
91676528|NCT02037165|183248034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.6|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.6|
91676529|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.5|3.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-1.5|
91692139|NCT01671007|183279050|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.49|1.84|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.84|0.49|
91486512|NCT00749515|182845629|OTHER|||||||0.104|||||||t-test, 2 sided|||||||.104
91486513|NCT00178633|182845660|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
91486514|NCT01484132|182845686|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.||||0.58
91486515|NCT01484132|182845686|SUPERIORITY_OR_OTHER||Slope|-0.061||||0.406|TWO_SIDED|95.0|-0.206|0.084||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.084|-0.206|0.406
91486516|NCT01484132|182845686|SUPERIORITY_OR_OTHER||Slope|-0.017||||0.693|TWO_SIDED|95.0|-0.101|0.067||P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.067|-0.101|0.693
91527509|NCT02875834|182930325|OTHER||Odds Ratio (OR)|6.3436|||<|0.001|TWO_SIDED|95.0|2.6866|14.9782|||Regression, Logistic|||Treatment group comparisons were made using a logistic regression model containing the following covariates: treatment group; both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase); baseline eGFR (during 48-hour open-label initial phase); age category (\<55, 55-64, \>=65 years); country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||14.9782|2.6866|<0.001
91527510|NCT02875834|182930325|OTHER||Odds Ratio (OR)|18.1876|||<|0.001|TWO_SIDED|95.0|7.1591|46.2054|||Regression, Logistic|||||46.2054|7.1591|<0.001
91676530|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
91676531|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|2.06|STANDARD_ERROR_OF_MEAN|0.1752|||TWO_SIDED|95.0|-0.2|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-0.2|
91676532|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-1.0|3.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.6|-1.0|
91676533|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.175|||TWO_SIDED|95.0|-1.2|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.2|
91676534|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.57|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-2.9|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.9|
91676535|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.43|STANDARD_ERROR_OF_MEAN|1.1752|||TWO_SIDED|95.0|-3.7|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-3.7|
91676536|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-2.1|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.1|
91676537|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.9|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-1.9|
91692140|NCT01671007|183279051|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.01|0.60|
91692141|NCT00449865|183279069|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Global Statistical Test|The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8).||||||0.45
91527511|NCT02875834|182930327|OTHER||Mean Difference (Final Values)|7.266|||<|0.001|TWO_SIDED|95.0|4.318|10.214|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||10.214|4.318|<0.001
91642860|NCT02087865|183177977|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.09||0.941|TWO_SIDED|95.0|-3.94|4.25|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||4.25|-3.94|0.941
91642861|NCT02087865|183177978|SUPERIORITY||Mean Difference (Final Values)|46.33|STANDARD_ERROR_OF_MEAN|15.4||0.003|TWO_SIDED|95.0|16.14|76.53|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||76.53|16.14|0.003
91486517|NCT01484132|182845686|SUPERIORITY_OR_OTHER||Slope|-0.123||||0.16|TWO_SIDED|95.0|-0.296|0.05||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.050|-0.296|0.160
91642862|NCT02087865|183177979|SUPERIORITY||Mean Difference (Final Values)|61.36|STANDARD_ERROR_OF_MEAN|13.32|<|0.001|TWO_SIDED|95.0|35.25|87.46|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||87.46|35.25|<0.001
91642863|NCT02087865|183177980|SUPERIORITY||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|1.18||0.005|TWO_SIDED|95.0|-5.65|-1.04|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.04|-5.65|0.005
91642864|NCT02087865|183177981|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.67||0.011|TWO_SIDED|95.0|-7.58|-1.02|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.02|-7.58|0.011
91642865|NCT00741026|183177989|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Wilcoxon Signed-rank|||||||0.0203
91642866|NCT00741026|183177990|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon Sign-rank|||||||0.0105
91642867|NCT00741026|183177991|SUPERIORITY_OR_OTHER|||||||0.0166|||||||Wilcoxon Sign-rank|||||||0.0166
91642868|NCT00741026|183177992|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Wilcoxon Sign-rank|||||||0.0184
91676538|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.68|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-4.0|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.0|
91692284|NCT03656068|183279591|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.61||||0.1556|TWO_SIDED|95.0|-16.16|2.94||p-value for testing mean = 0|t-test, 2 sided|||||2.94|-16.16|0.1556
91642869|NCT00741026|183177993|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Sign-rank|||||||0.0170
91642870|NCT03309072|183178001|OTHER|To compare the old and new faces' hit rate, we calculated the true positive rate (TPR: the proportion of positives that are correctly identified as such). A repeated measures ANOVA was conducted with the TPR for both old and new faces as within-subjects variable and group (active vs sham) as between-subjects variable.|Mean Difference (Net)|10.66|||<|0.049|TWO_SIDED||||||ANOVA||Difference between active tDCS and sham tDCS|||||<.049
91642871|NCT00367679|183178061|SUPERIORITY_OR_OTHER||Percentage of participants with response|5.7||||||95.0|0.7|19.2|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||19.2|0.7|
91642872|NCT00367679|183178062|SUPERIORITY_OR_OTHER||Percentage of participants with response|8.6||||||95.0|1.8|23.1|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||23.1|1.8|
91642873|NCT00367679|183178068|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||VEGF D|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0028
91642874|NCT00367679|183178068|SUPERIORITY_OR_OTHER|||||||0.0324||95.0||||VEGF A|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0324
91642875|NCT00367679|183178068|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||VEGFR-2|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
91642876|NCT00367679|183178068|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||c-KIT|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
91642877|NCT00367679|183178074|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Vascular endothelial growth factor receptor 2 (VEGFR2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
91642878|NCT00367679|183178074|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Placental growth factor (PIGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
91642879|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.00024||95.0||||Interferon-inducible cytokine (IP-10)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.00024
91642880|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Cutaneous T-cell attracting chemokine (CTACK)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0029
91642881|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||Stromal cell-derived factor 1 (SDF-1alpha)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0062
91642882|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.0069||95.0||||Monokine induced by interferon gamma (MIG)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0069
91642883|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||Tumor necrosis factor ligand (TRAIL)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0093
91676539|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
91676540|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|1.89|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-0.4|4.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.2|-0.4|
91676541|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|1.25|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.0|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-1.0|
91676542|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.6|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.6|
91676543|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference of 200 mg BI mi|-0.43|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-2.7|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.7|
91486518|NCT01484132|182845686|SUPERIORITY_OR_OTHER||Slope|-0.029||||0.574|TWO_SIDED|95.0|-0.131|0.073||P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.073|-0.131|0.574
91486519|NCT01484132|182845687|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.11
91486520|NCT01484132|182845687|SUPERIORITY_OR_OTHER||Slope|0.299||||0.003|TWO_SIDED|95.0|0.105|0.494||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.494|0.105|0.003
91486521|NCT01484132|182845687|SUPERIORITY_OR_OTHER||Slope|0.365||||0.002|TWO_SIDED|95.0|0.145|0.585||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.585|0.145|0.002
91486522|NCT01484132|182845688|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.27
91486523|NCT01484132|182845688|SUPERIORITY_OR_OTHER||Slope|-0.068||||0.48|TWO_SIDED|95.0|-0.258|0.123||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.123|-0.258|0.480
91527512|NCT02875834|182930327|OTHER||Mean Difference (Final Values)|12.079|||<|0.001|TWO_SIDED|95.0|9.118|15.04|||Regression, Linear|||||15.040|9.118|<0.001
91486524|NCT01484132|182845688|SUPERIORITY_OR_OTHER||Slope|-0.074||||0.501|TWO_SIDED|95.0|-0.293|0.145||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.145|-0.293|0.501
91642884|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Interferon alpha 2 (IFN-alpha2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.021
91642885|NCT00367679|183178074|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||Vascular endothelial growth factor (VEGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.326
91642886|NCT01005680|183178088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.822|TWO_SIDED|95.0|0.77|1.39||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.39|0.77|0.822
91642887|NCT01005680|183178089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.64|TWO_SIDED|95.0|0.82|1.37||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.37|0.82|0.640
91642888|NCT01005680|183178090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.78|1.32||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.|Cox Proportional Hazard|||||1.32|0.78|0.928
91642889|NCT01005680|183178091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.51|1.79||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.79|0.51|0.887
91642890|NCT01005680|183178092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.861|TWO_SIDED|95.0|0.67|1.61||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.61|0.67|0.861
91642891|NCT01005680|183178093|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||two-sided Z test|||||||0.451
91642892|NCT01005680|183178095|SUPERIORITY_OR_OTHER|||||||0.627||95.0|||||two-sided Z test|||||||0.627
91642893|NCT00297882|183178102|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
91642894|NCT00297882|183178103|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
91642895|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9257|||||TWO_SIDED|95.0|0.844|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.844|
91642896|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9321|||||TWO_SIDED|95.0|0.858|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.858|
91642897|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
91692285|NCT03656068|183279592|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-14.6||||0.0709|TWO_SIDED|95.0|-30.6|1.4||p-value for testing mean = 0|t-test, 2 sided|||||1.4|-30.6|0.0709
91486525|NCT01484132|182845689|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.41
91642898|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8699|||||TWO_SIDED|95.0|0.79|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.949|0.790|
91642899|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9607|||||TWO_SIDED|95.0|0.927|0.995||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.995|0.927|
91642900|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9948|||||TWO_SIDED|95.0|0.985|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.985|
91642901|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
91642902|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
91642903|NCT02118896|183178106|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.933|
91486526|NCT01484132|182845689|SUPERIORITY_OR_OTHER||Slope|-0.082||||0.612|TWO_SIDED|95.0|-0.418|0.254||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.254|-0.418|0.612
91486527|NCT01484132|182845689|SUPERIORITY_OR_OTHER||Slope|0.078||||0.696|TWO_SIDED|95.0|-0.339|0.495||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.495|-0.339|0.696
91486528|NCT01484132|182845690|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.76
91676544|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-3.0|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.0|
91676545|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-2.2|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-2.2|
91692286|NCT03656068|183279593|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.61||||0.1799|TWO_SIDED|95.0|-9.02|1.81||p-value for testing mean = 0|t-test, 2 sided|||||1.81|-9.02|0.1799
91692287|NCT03656068|183279594|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.8||||0.3306|TWO_SIDED|95.0|-21.2|7.6||p-value for testing mean = 0|t-test, 2 sided|||||7.6|-21.2|0.3306
91486529|NCT01484132|182845690|SUPERIORITY_OR_OTHER||Slope|-0.018||||0.968|TWO_SIDED|95.0|-1.061|1.025||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||1.025|-1.061|0.968
91527513|NCT02875834|182930330|OTHER||Hazard Ratio (HR)|0.443|||<|0.001|TWO_SIDED|95.0|0.2954|0.6631|||Regression, Cox|||Results derived from a Cox Proportional Hazards model with the following covariates: treatment group, both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase), baseline eGFR, age category (\<55, 55-64, \>=65 years), country, baseline RAAS inhibitor, chronic kidney, disease heart failure, and diabetes mellitus statuses.||0.6631|0.2954|<0.001
91692288|NCT03656068|183279595|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.94||||0.4504|TWO_SIDED|95.0|-7.25|3.37||p-value for testing mean = 0|t-test, 2 sided|||||3.37|-7.25|0.4504
91692289|NCT03656068|183279596|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|33.8||||0.1349|TWO_SIDED|95.0|-11.5|79.0||p-value for testing mean = 0|t-test, 2 sided|||||79.0|-11.5|0.1349
91692290|NCT03656068|183279597|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|76.24||||0.0117|TWO_SIDED|95.0|19.04|133.43||p-value for testing mean = 0|t-test, 2 sided|||||133.43|19.04|0.0117
91692291|NCT03656068|183279598|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|31.3||||0.4281|TWO_SIDED|95.0|-50.3|112.9||p-value for testing mean = 0|t-test, 2 sided|||||112.9|-50.3|0.4281
91692292|NCT03656068|183279599|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|117.37||||0.0407|TWO_SIDED|95.0|5.6|229.14||p-value for testing mean = 0|t-test, 2 sided|||||229.14|5.60|0.0407
91692293|NCT03656068|183279600|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|47.28||||0.7065|TWO_SIDED|95.0|-210.9|305.46||p-value for testing mean = 0|t-test, 2 sided|||||305.46|-210.90|0.7065
91692294|NCT03656068|183279601|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|43.11||||0.1693|TWO_SIDED|95.0|-19.95|106.17||p-value for testing mean = 0|t-test, 2 sided|||||106.17|-19.95|0.1693
91692295|NCT03656068|183279602|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-48.14||||0.7099|TWO_SIDED|95.0|-317.64|221.36||p-value for testing mean = 0|t-test, 2 sided|||||221.36|-317.64|0.7099
91692296|NCT03656068|183279603|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.03||||0.3597|TWO_SIDED|95.0|-37.48|97.55||p-value for testing mean = 0|t-test, 2 sided|||||97.55|-37.48|0.3597
91692297|NCT03656068|183279604|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|169.0||||0.9893|TWO_SIDED|95.0|-25908.2|26246.2||p-value for testing mean = 0|t-test, 2 sided|||||26246.2|-25908.2|0.9893
91717061|NCT01687218|183326487|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0005|TWO_SIDED|95.0|0.19|0.63|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||0.63|0.19|0.0005
91717062|NCT01687218|183326487|SUPERIORITY||Odds Ratio (OR)|0.89||||0.74|TWO_SIDED|95.0|0.43|1.81|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||1.81|0.43|0.74
91717063|NCT02084511|183326502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.39|||||TWO_SIDED|95.0|-76.3|131.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||131.1|-76.3|
91717064|NCT02084511|183326502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.48|||||TWO_SIDED|95.0|-50.2|157.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||157.1|-50.2|
91642904|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8391|||||TWO_SIDED|95.0|0.729|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.949|0.729|
91642905|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8792|||||TWO_SIDED|95.0|0.778|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula..||0.981|0.778|
91642906|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8816|||||TWO_SIDED|95.0|0.782|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.782|
91642907|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.7769|||||TWO_SIDED|95.0|0.675|0.878||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.878|0.675|
91642908|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8373|||||TWO_SIDED|95.0|0.693|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.693|
91642909|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9419|||||TWO_SIDED|95.0|0.883|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.883|
91642910|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|1.000|
91642911|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9898|||||TWO_SIDED|95.0|0.97|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.970|
91642912|NCT02118896|183178109|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.933|
91642913|NCT04242264|183178110|SUPERIORITY|A two-sided Chi-squared test with alpha=0.05 was used to test the null hypothesis that the vaccine efficacy is zero, which is equivalent to testing that the relative risk of shigellosis is one.|Vaccine efficacy|0.89|||<|0.001|TWO_SIDED|95.0|0.71|0.96|||Chi-squared||Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate.|The null hypothesis is that the absolute vaccine efficacy (VE) of preventing shigellosis is zero. The alternative hypothesis is that the absolute VE is greater than zero.||0.96|0.71|<0.001
91642914|NCT04242264|183178111|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|0.77|||||TWO_SIDED|95.0|0.44|0.92||||||||0.92|0.44|
91642915|NCT04242264|183178111|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.78|1.0||||||||1.00|0.78|
91642916|NCT04242264|183178111|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.71|1.0||||||||1.00|0.71|
91642917|NCT04221373|183178131|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 117.78||SCIM Total Score||||<0.01
91642918|NCT04221373|183178131|OTHER|Mixed-effects model||||||0.03||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.59||SCIM Total Score||||0.03
91642919|NCT04221373|183178131|OTHER|Mixed-effects model||||||0.01||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.02||SCIM R \& S scores||||0.01
91717065|NCT02084511|183326502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-174.61|||||TWO_SIDED|95.0|-278.3|-70.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-70.9|-278.3|
91676546|NCT02037165|183248035|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-3.0|1.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.6|-3.0|
91676547|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.7|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.7|
91676548|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.2|
91676549|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.7|
91692298|NCT03656068|183279605|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|13.82||||0.1454|TWO_SIDED|95.0|-5.21|32.85||p-value for testing mean = 0|t-test, 2 sided|||||32.85|-5.21|0.1454
91692299|NCT03656068|183279606|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3016.8||||0.8089|TWO_SIDED|95.0|-22996.2|29029.7||p-value for testing mean = 0|t-test, 2 sided|||||29029.7|-22996.2|0.8089
91692300|NCT03656068|183279607|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.78||||0.1365|TWO_SIDED|95.0|-4.5|30.06||p-value for testing mean = 0|t-test, 2 sided|||||30.06|-4.50|0.1365
91692301|NCT03656068|183279608|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.954||||0.1322|TWO_SIDED|95.0|-9.525|67.433||p-value for testing mean = 0|t-test, 2 sided|||||67.433|-9.525|0.1322
91692302|NCT03656068|183279609|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.99||||0.1062|TWO_SIDED|95.0|-5.59|53.57|||t-test, 2 sided|p-value for testing mean = 0||||53.57|-5.59|0.1062
91692303|NCT03656068|183279610|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.311||||0.0831|TWO_SIDED|95.0|-4.151|60.774||p-value for testing mean = 0|t-test, 2 sided|||||60.774|-4.151|0.0831
91692304|NCT03656068|183279611|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|32.72||||0.0543|TWO_SIDED|95.0|-0.69|66.13||p-value for testing mean = 0|t-test, 2 sided|||||66.13|-0.69|0.0543
91692305|NCT03656068|183279612|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.056||||0.6325|TWO_SIDED|95.0|-0.185|0.298||p-value for testing mean = 0|t-test, 2 sided|||||0.298|-0.185|0.6325
91692306|NCT03656068|183279613|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.46||||0.6925|TWO_SIDED|95.0|-1.94|2.87||p-value for testing mean = 0|t-test, 2 sided|||||2.87|-1.94|0.6925
91692307|NCT03656068|183279614|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.161||||0.2733|TWO_SIDED|95.0|-0.14|0.462|||t-test, 2 sided|||||0.462|-0.140|0.2733
91692308|NCT03656068|183279615|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.47||||0.3288|TWO_SIDED|95.0|-1.63|4.56||p-value for testing mean = 0|t-test, 2 sided|||||4.56|-1.63|0.3288
91692309|NCT03656068|183279616|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.649||||0.9271|TWO_SIDED|95.0|-121.923|133.22||p-value for testing mean = 0|t-test, 2 sided|||||133.220|-121.923|0.9271
91692310|NCT03656068|183279617|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.89||||0.9244|TWO_SIDED|95.0|-18.58|20.37||p-value for testing mean = 0|t-test, 2 sided|||||20.37|-18.58|0.9244
91692311|NCT03656068|183279618|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-30.244||||0.7288|TWO_SIDED|95.0|-211.93|151.441||p-value for testing mean = 0|t-test, 2 sided|||||151.441|-211.930|0.7288
91692312|NCT03656068|183279619|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.34||||0.7824|TWO_SIDED|95.0|-21.85|28.52||p-value for testing mean = 0|t-test, 2 sided|||||28.52|-21.85|0.7824
91692313|NCT03656068|183279620|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-47.629||||0.6448|TWO_SIDED|95.0|-260.433|165.176||p-value for testing mean = 0|t-test, 2 sided|||||165.176|-260.433|0.6448
91692314|NCT03656068|183279621|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.9806|TWO_SIDED|95.0|-32.04|32.8||p-value for testing mean = 0|t-test, 2 sided|||||32.80|-32.04|0.9806
91692315|NCT03656068|183279622|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-113.616||||0.3256|TWO_SIDED|95.0|-351.124|123.891||p-value for testing mean = 0|t-test, 2 sided|||||123.891|-351.124|0.3256
91692316|NCT03656068|183279623|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.78||||0.6582|TWO_SIDED|95.0|-32.52|50.09||p-value for testing mean = 0|t-test, 2 sided|||||50.09|-32.52|0.6582
91717066|NCT02084511|183326502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.53|||||TWO_SIDED|95.0|-252.4|-44.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-44.7|-252.4|
91717067|NCT02084511|183326503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-2.3|5.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.7|-2.3|
91717068|NCT02084511|183326503|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.98|||||TWO_SIDED|95.0|-3.0|5.0|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.0|-3.0|
91717069|NCT02084511|183326503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-10.3|-2.2|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.2|-10.3|
91717070|NCT02084511|183326503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.98|||||TWO_SIDED|95.0|-11.0|-2.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.9|-11.0|
91717071|NCT02084511|183326504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|||||TWO_SIDED|95.0|-16.0|27.8|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||27.8|-16.0|
91717072|NCT02084511|183326504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.58|||||TWO_SIDED|95.0|-1.3|42.5|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||42.5|-1.3|
91717073|NCT02084511|183326504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|||||TWO_SIDED|95.0|-35.2|8.6|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||8.6|-35.2|
91717074|NCT02084511|183326504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-20.6|23.3|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||23.3|-20.6|
91717075|NCT02084511|183326505|SUPERIORITY_OR_OTHER|||||||0.2503|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.2503
91717076|NCT02084511|183326505|SUPERIORITY_OR_OTHER|||||||0.1851|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.1851
91717077|NCT02084511|183326505|SUPERIORITY_OR_OTHER|||||||0.0167|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0167
91717078|NCT02084511|183326506|SUPERIORITY_OR_OTHER|||||||0.415|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.4150
91717079|NCT02084511|183326506|SUPERIORITY_OR_OTHER|||||||0.3093|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.3093
91717080|NCT02084511|183326506|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0074
91717081|NCT00461734|183326508|SUPERIORITY_OR_OTHER|||||||0.4347|||||||two-sided z-test|||||||0.4347
91717082|NCT00461734|183326509|SUPERIORITY_OR_OTHER|||||||0.338|||||||two-sided z-test|||||||0.338
91717083|NCT00461734|183326510|SUPERIORITY_OR_OTHER|||||||0.2257|||||||Wilcoxon (Mann-Whitney)|||||||0.2257
91717084|NCT00461734|183326511|SUPERIORITY_OR_OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.5480
91717085|NCT00461734|183326512|SUPERIORITY_OR_OTHER|||||||0.8868|||||||Wilcoxon (Mann-Whitney)|||||||0.8868
91717086|NCT00461734|183326513|SUPERIORITY_OR_OTHER|||||||0.6151|||||||Wilcoxon (Mann-Whitney)|||||||0.6151
91717087|NCT00461734|183326517|SUPERIORITY_OR_OTHER|||||||0.0525|||||||t-test, 2 sided|||||||0.0525
91717088|NCT00461734|183326518|SUPERIORITY_OR_OTHER|||||||0.1852|||||||t-test, 2 sided|||||||0.1852
91717089|NCT00461734|183326520|SUPERIORITY_OR_OTHER|||||||0.9719|||||||Wilcoxon (Mann-Whitney)|||||||0.9719
91717090|NCT00461734|183326521|SUPERIORITY_OR_OTHER|||||||0.8779|||||||Wilcoxon (Mann-Whitney)|||||||0.8779
91717091|NCT03204643|183326533|SUPERIORITY||Odds Ratio (OR)|0.74||||0.06|TWO_SIDED|95.0|0.54|1.02|||Regression, Logistic|||||1.02|0.54|0.06
91486530|NCT01484132|182845690|SUPERIORITY_OR_OTHER||Slope|-0.083||||0.822|TWO_SIDED|95.0|-0.941|0.775||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.775|-0.941|0.822
91486531|NCT00620464|182845693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||90.0||||Applies to all parameters.|Bioequivalence Testing|||||||0.05
91486532|NCT00620464|182845694|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.05||95.0|||||Bioequivalence Testing|||||||<=0.05
91642920|NCT04221373|183178131|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 72.49||SCIM R \& S scores||||< 0.01
91642921|NCT04221373|183178132|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.82||LEMS||||0.02
91642922|NCT04221373|183178132|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 33.29||LEMS||||<0.01
91642923|NCT04221373|183178132|OTHER|Mixed-effects model||||||0.04||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 4.58||UEMS||||0.04
91642924|NCT04221373|183178132|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 15.34||UEMS||||<0.01
91642925|NCT04221373|183178132|OTHER|Mixed-effects model|||||<|0.01||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.06||TMS||||<0.01
91642926|NCT04221373|183178132|OTHER|TMS|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1,26) = 38.91||||||<0.01
91642927|NCT04221373|183178132|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,21.7) = 6.23||TLTS||||0.02
91642928|NCT04221373|183178132|OTHER|Mixed-effects model||||||0.05||||||Main effect of time|Mixed Models Analysis|F(1 26)=4.14||TLTS||||0.05
91642929|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.485||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.51||Average worst pain intensity||||0.485
91486533|NCT04246372|182845739|OTHER||Effect size (Cohen's d)|-0.84||||6.21e-06|||||||t-test, 2 sided|Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.||||||0.00000621
91486534|NCT04246372|182845740|OTHER||Effect size (Cohen's d)|-0.91||||6.1e-07||||||Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.|t-test, 2 sided|||||||0.00000061
91486535|NCT04246372|182845741|OTHER||Effect size (Cohen's d)|-1.03||||4e-08|TWO_SIDED|||||Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.|t-test, 2 sided|||||||0.00000004
91642930|NCT04221373|183178133|OTHER|Mixed-effects model||||||0||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 26.71||Average worst pain intensity||||0.000
91642931|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.832||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.05||Worst pain interference with day-to-day activities||||0.832
91642932|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.033||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 5.21||Worst pain interference with day-to-day activities||||0.033
91642933|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.692||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 42) = 0.16||Worst pain interference with overall mood||||0.692
91642934|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.005||||||Main effect of time|Mixed Models Analysis|F(1, 42) = 8.65||Worst pain interference with overall mood||||0.005
91642935|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.946||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1,21) = 0.01||Worst pain interfered with sleep||||0.946
91642936|NCT04221373|183178133|OTHER|Mixed-effects model||||||0.0002||||||Main effect of time|Mixed Models Analysis|F(1,21) = 11.94||Worst pain interference with sleep||||0.0002
91642937|NCT04221373|183178134|SUPERIORITY|||||||0.554|||||||Chi-squared|X\^2 (1, N = 23) = 0.35||Baseline||||0.554
91486536|NCT04246372|182845743|OTHER||Effect size (Cohen's d)|-1.14||||3.93e-05||||||Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.|t-test, 2 sided|||||||0.0000393
91486537|NCT04246372|182845744|OTHER||Effect size (Cohen's d)|-0.67||||0.00399||||||Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.|t-test, 2 sided|||||||0.00399
91486538|NCT04246372|182845745|OTHER||Effect size (Cohen's d)|-3.04||||0.146||||||Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.|t-test, 2 sided|||||||0.146
91486539|NCT04246372|182845747|OTHER||Effect size (Cohen's d)|-1.05||||9e-08||||||Two-sided paired Student t test comparing the values for each participant at Baseline and 16 weeks.|t-test, 2 sided|||||||0.00000009
91486540|NCT00257608|182845749|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.708||||0.0006|TWO_SIDED|95.0|0.58|0.864|||Log Rank|||||0.864|0.580|0.0006
91486541|NCT00257608|182845755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.5341|TWO_SIDED|95.0|0.698|1.205|||Log Rank|||||1.205|0.698|0.5341
91527514|NCT02875834|182930330|OTHER||Hazard Ratio (HR)|0.158|||<|0.001|TWO_SIDED|95.0|0.0992|0.2508|||Regression, Cox|||||0.2508|0.0992|<0.001
91527515|NCT01302938|182930333|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-3.9|0.6||||||Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.||0.6|-3.9|
91642938|NCT04221373|183178134|SUPERIORITY|||||||0.949|||||||Chi-squared|X\^2 (1, N = 23) = 0.004||discharge from acute inpatient rehabilitation (average 2-3 weeks)||||0.949
91642939|NCT00561600|183178153|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority of proportion successful with 8% non inferiority margin at 24 months|percentage difference|0.139||||0.872|ONE_SIDED|95.0||0.225|||Chi-squared||The upper confidence limit was a priori determined to be a secondary endpoint|A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt \< 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.||.225||0.872
91642940|NCT00561600|183178154|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||t-test, 2 sided|Satterthwaite||||||0.167
91642941|NCT00561600|183178157|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
91717092|NCT03204643|183326534|SUPERIORITY||Odds Ratio (OR)|1.07||||0.76|TWO_SIDED|95.0|0.7|1.64|||Mixed Models Analysis|||||1.64|0.70|0.76
91717093|NCT03204643|183326535|SUPERIORITY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.65|2.08|||Mixed Models Analysis|||||2.08|0.65|0.62
91717094|NCT03204643|183326536|SUPERIORITY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|0.96|0.96|1.9|||Mixed Models Analysis|||||1.90|0.96|0.08
91717095|NCT00944710|183326543|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.0||||0.33|TWO_SIDED|95.0|-10.0|30.0|||Binomial regression|adjusted for visual acuity at randomization||||30|-10|0.33
91717096|NCT00944710|183326548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.12|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.|Positive values favor the Intensified Treatment group|The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||0.12|-0.01|0.12
91717097|NCT00944710|183326556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.23|0.43|||ANCOVA|||A treatment group difference in fellow-eye visual acuity change at the 12-week exam was evaluated using an ANCOVA model, adjusting for the fellow-eye visual acuity at randomization.||0.43|-0.23|0.55
91717098|NCT00944710|183326565|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.23
91527516|NCT01302938|182930334|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|29.4|STANDARD_ERROR_OF_MEAN|35.4|||TWO_SIDED|95.0|-47.8|106.6||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||106.6|-47.8|
91717099|NCT00944710|183326566|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.66
91717100|NCT02175225|183326594|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.006|||||ONE_SIDED|90.0||0.068|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.068||
91717101|NCT02175225|183326595|OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
91717102|NCT02175225|183326596|OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.57|1.56||||||||1.56|0.57|
91717103|NCT02175225|183326597|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than13% in favor of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.062|||||ONE_SIDED|90.0||0.121|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference\[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.121||
91717104|NCT02175225|183326598|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.086|||||ONE_SIDED|90.0||0.156|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.156||
91717105|NCT02175225|183326599|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 13% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|-0.018|||||ONE_SIDED|90.0||0.029|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.029||
91717106|NCT02175225|183326600|OTHER|||||||0.83||||||The p value reflects the significance of the interaction term between treatment and onset to treatment time.|Regression, Logistic|||||||0.83
91717107|NCT02175225|183326601|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.72|1.67|||||The estimation parameter is the adjusted common odds ratio.|||1.67|0.72|
91717108|NCT02175225|183326602|OTHER||Odds Ratio, log|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||||1.93|0.82|
91717109|NCT02175225|183326605|OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.0|14.97|||||Confidence interval is exact (rather than asymptotic) due to small number of events.|||14.97|0.0|
91717110|NCT02175225|183326606|OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.54|||||Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.|||1.54|0.51|
91717111|NCT02175225|183326607|OTHER||Risk Ratio (RR)|1.84|||||TWO_SIDED|95.0|0.63|5.35||||||||5.35|0.63|
91717112|NCT02008526|183326615|SUPERIORITY||F|1.16||||0.3137|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.3137
91526676|NCT03661996|182928693|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.959|STANDARD_ERROR_OF_MEAN|1.0221|||TWO_SIDED|95.0|0.919|1.001|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.001|0.919|
91642942|NCT00561600|183178158|SUPERIORITY_OR_OTHER|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
91642943|NCT00561600|183178159|SUPERIORITY_OR_OTHER|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||||||0.869
91642944|NCT00561600|183178160|SUPERIORITY_OR_OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
91717113|NCT02008526|183326616|SUPERIORITY||F|0.16||||0.8494|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.8494
91717114|NCT01062308|183326619|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|-11.8||||0.03|TWO_SIDED|95.0|-22.6|-1.1|||Mixed Models Analysis|||||-1.1|-22.6|0.03
91717115|NCT01062308|183326620|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|6.6||||0.16|TWO_SIDED|95.0|-2.7|15.9|||Mixed Models Analysis|||||15.9|-2.7|0.16
91717116|NCT01190813|183326634|SUPERIORITY_OR_OTHER||Percent Difference|11.0||||0.06|TWO_SIDED|95.0|-7.0|28.0|||Fisher Exact|It was not possible to adjust for baseline VA in these secondary analyses due to the small number of subjects meeting secondary outcome criteria.|Treatment group difference calculated as Levodopa - Placebo|A sample size of 129 participants provided 80% power with 1-sided type I error rate of 5% to reject the hypothesis of no difference between groups if the proportion improved was 30% in the levodopa group compared with 10% in the placebo group.||28|-7|0.06
91717117|NCT01190813|183326637|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-17.0|18.0|||||Levodopa - Placebo|||18|-17|
91717118|NCT01190813|183326638|SUPERIORITY_OR_OTHER||Percent Difference|-7.0|||||TWO_SIDED|95.0|-25.0|10.0||||||||10|-25|
91717119|NCT01190813|183326639|SUPERIORITY_OR_OTHER||Percent Difference|-5.0|||||TWO_SIDED|95.0|-22.0|13.0|||||Levodopa - Placebo|||13|-22|
91717120|NCT01190813|183326647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.65|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA||Mean difference calculated as Levodopa - Placebo|||1.3|-1.9|0.65
91717121|NCT01190813|183326649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||||1.8|-1.6|0.44
91717122|NCT01190813|183326651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|95.0|-1.2|2.9|||ANCOVA|||||2.9|-1.2|0.20
91717123|NCT01190813|183326653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
91717124|NCT01190813|183326657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.06|TWO_SIDED|95.0|-0.4|3.3||The alpha level was set to 0.0485 for the primary analysis to adjust for alpha spending of 0.015 for one interim analysis for efficacy conducted when outcome data were available for 50% of participants.|ANCOVA||Mean difference calculated as Levodopa - Placebo|With 129 participants, assuming a 1-sided type I error rate of 4.85%, there was 96% power to detect a difference in mean visual acuity between treatment groups at 18 weeks adjusted for baseline and for 1 interim analysis for futility if the true difference was 5 letters with SD of 7 letters and 82% power if the true difference was 3.75 letters||3.3|-0.4|0.06
91717125|NCT01248416|183326731|SUPERIORITY||||||<|0.006|||||||ANCOVA|||||||<0.006
91717126|NCT01248416|183326733|SUPERIORITY|||||||0.906|||||||ANOVA|||||||0.906
91717127|NCT01248416|183326734|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
91717128|NCT01248416|183326736|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91717129|NCT01248416|183326737|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91717130|NCT01248416|183326738|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
91642945|NCT00561600|183178161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||<0.001
91642946|NCT00561600|183178162|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.032
91642947|NCT00561600|183178163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||<0.001
91642948|NCT00561600|183178164|SUPERIORITY_OR_OTHER|||||||0.882|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.882
91642949|NCT00561600|183178165|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.005
91642950|NCT00561600|183178166|SUPERIORITY_OR_OTHER|||||||0.237|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.237
91642951|NCT00561600|183178167|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
91642952|NCT00561600|183178168|SUPERIORITY_OR_OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.121
91676550|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
91676551|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
91676552|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
91676553|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-3.7|
91676554|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
91692317|NCT03656068|183279624|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2438||||0.5459|TWO_SIDED|95.0|-1.0847|0.5972||p-value for testing mean = 0|t-test, 2 sided|||||0.5972|-1.0847|0.5459
91692318|NCT03656068|183279625|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.91||||0.286|TWO_SIDED|95.0|-22.15|69.97|||t-test, 2 sided|||||69.97|-22.15|0.2860
91642953|NCT00561600|183178169|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group||||0.012
91486542|NCT03673046|182845756|SUPERIORITY||Mean Difference (Final Values)|-10.1255|STANDARD_ERROR_OF_MEAN|1.5705|<|0.0001|TWO_SIDED|95.0|-13.2532|-6.9978||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-eeek waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BDD-YBOCS total scores between the treatment groups at endpoint (week 12).||-6.9978|-13.2532|<.0001
91642954|NCT00561600|183178170|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.103
91717131|NCT04745351|183326740|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.6132|TWO_SIDED|95.0|0.504|1.321||P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.|Log Rank|||||1.321|0.504|0.6132
91717132|NCT04745351|183326741|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3881|TWO_SIDED|95.0|0.497|1.388||P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.|Log Rank|||||1.388|0.497|0.3881
91717133|NCT04745351|183326742|SUPERIORITY||Hazard Ratio (HR)|1.043||||0.9116|TWO_SIDED|95.0|0.493|2.207||The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.|Regression, Cox|||||2.207|0.493|0.9116
91642955|NCT00561600|183178171|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
91642956|NCT00561600|183178172|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.300
91642957|NCT00561600|183178173|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.079
91642958|NCT00561600|183178174|SUPERIORITY_OR_OTHER|||||||0.766|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.766
91642959|NCT00561600|183178175|SUPERIORITY_OR_OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.018
91642960|NCT00561600|183178176|SUPERIORITY_OR_OTHER|||||||0.689|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.689
91642961|NCT00561600|183178177|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.048
91642962|NCT00561600|183178178|SUPERIORITY_OR_OTHER|||||||0.782|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.782
91642963|NCT00561600|183178179|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.061
91642964|NCT00561600|183178180|SUPERIORITY_OR_OTHER|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.957
91642965|NCT04139642|183178186|SUPERIORITY||||||<|0.0001||||||A mixed-effects model with provider as a random effect and month as a fixed effect was used to test the main effect of arm.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related diagnosis as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||<0.0001
91642966|NCT04139642|183178187|SUPERIORITY||||||=|0.15||||||Mixed-effects model with provider as a random effect and month as a fixed effect. Statistical significance a priori threshold set at 0.05.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related referral as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||=0.15
91642967|NCT01040624|183178189|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|One-sided binomial test of univariate probability distributions||||||<0.0001
91642968|NCT00577031|183178223|SUPERIORITY_OR_OTHER|||||||0.0076|||||||Signed-rank test|||Change from baseline to last visit||||0.0076
91692319|NCT03656068|183279626|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2893||||0.4887|TWO_SIDED|95.0|-1.158|0.5794||p-value for testing mean = 0|t-test, 2 sided|||||0.5794|-1.1580|0.4887
91692320|NCT03656068|183279627|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.27||||0.361|TWO_SIDED|95.0|-38.21|98.75||p-value for testing mean = 0|t-test, 2 sided|||||98.75|-38.21|0.3610
91692321|NCT03656068|183279628|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.63||||0.4945|TWO_SIDED|95.0|-2.51|1.26||p-value for testing mean = 0|t-test, 2 sided|||||1.26|-2.51|0.4945
91692322|NCT03656068|183279629|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.99||||0.8191|TWO_SIDED|95.0|-9.94|7.95||p-value for testing mean = 0|t-test, 2 sided|||||7.95|-9.94|0.8191
91692323|NCT03656068|183279630|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.22||||0.0243|TWO_SIDED|95.0|-5.96|-0.47||p-value for testing mean = 0|t-test, 2 sided|||||-0.47|-5.96|0.0243
91692324|NCT03656068|183279631|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-9.94||||0.0493|TWO_SIDED|95.0|-19.84|-0.04||p-value for testing mean = 0|t-test, 2 sided|||||-0.04|-19.84|0.0493
91692325|NCT03656068|183279632|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.6||||0.3066|TWO_SIDED|95.0|-0.59|1.79||p-value for testing mean = 0|t-test, 2 sided|||||1.79|-0.59|0.3066
91692326|NCT03656068|183279633|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.4||||0.2671|TWO_SIDED|95.0|-2.82|9.63||p-value for testing mean = 0|t-test, 2 sided|||||9.63|-2.82|0.2671
91486543|NCT03673046|182845757|SUPERIORITY||Mean Difference (Final Values)|-3.2648|STANDARD_ERROR_OF_MEAN|1.0346||0.0023|TWO_SIDED|95.0|-5.3275|-1.2022||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in QIDS-SR total scores between the treatment groups at endpoint (week 12).||-1.2022|-5.3275|0.0023
91642969|NCT01569074|183178246|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.23||||0.059|TWO_SIDED|80.0|0.07|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||0.39|0.07|0.059
91642970|NCT01569074|183178246|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.24||||0.054|TWO_SIDED|80.0|0.08|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.39|0.08|0.054
91642971|NCT01569074|183178246|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.06||||0.57|TWO_SIDED|80.0|-0.2|0.08||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.08|-0.20|0.570
91642972|NCT01569074|183178246|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.262|TWO_SIDED|80.0|-0.02|0.29||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.29|-0.02|0.262
91642973|NCT01569074|183178247|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.11||||0.172|TWO_SIDED|80.0|0.01|0.21||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.21|0.01|0.172
91642974|NCT01569074|183178247|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.06||||0.489|TWO_SIDED|80.0|-0.05|0.18||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.18|-0.05|0.489
91642975|NCT01569074|183178247|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.704|TWO_SIDED|80.0|-0.08|0.15||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.15|-0.08|0.704
91676555|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
91676556|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-2.5|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.5|
91676557|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-4.5|-0.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.2|-4.5|
91527517|NCT01302938|182930334|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|28.0|STANDARD_ERROR_OF_MEAN|38.9|||TWO_SIDED|95.0|-55.4|111.4||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||111.4|-55.4|
91527518|NCT01302938|182930334|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|43.0|STANDARD_ERROR_OF_MEAN|31.4|||TWO_SIDED|95.0|-24.2|110.3||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||110.3|-24.2|
91527519|NCT01302938|182930335|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.67|1.67||||||Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).||1.67|-0.67|
91642976|NCT01569074|183178248|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.17||||0.114|TWO_SIDED|80.0|0.03|0.31||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.31|0.03|0.114
91676558|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.39|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.6|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.6|
91676559|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.38|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.5|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.5|
91676560|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15|STANDARD_ERROR_OF_MEAN|1.0983|||TWO_SIDED|95.0|-3.3|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-3.3|
91676561|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-2.8|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-2.8|
91676562|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.53|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-3.7|
91692327|NCT03656068|183279634|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.11||||0.8241|TWO_SIDED|95.0|-0.94|1.16||p-value for testing mean = 0|t-test, 2 sided|||||1.16|-0.94|0.8241
91486544|NCT03673046|182845758|SUPERIORITY||Mean Difference (Final Values)|-4.8412|STANDARD_ERROR_OF_MEAN|1.1195|<|0.0001|TWO_SIDED|95.0|-7.0698|-2.6126||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BABS total scores between the treatment groups at endpoint (week 12).||-2.6126|-7.0698|<.0001
91642977|NCT01569074|183178248|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.21||||0.035|TWO_SIDED|80.0|0.08|0.34||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.34|0.08|0.035
91642978|NCT01569074|183178248|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.07||||0.334|TWO_SIDED|80.0|-0.17|0.02||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.02|-0.17|0.334
91642979|NCT01569074|183178248|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.04||||0.645|TWO_SIDED|80.0|-0.13|0.06||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.06|-0.13|0.645
91642980|NCT01569074|183178249|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.12||||0.028|TWO_SIDED|80.0|0.05|0.19||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.19|0.05|0.028
91642981|NCT01569074|183178249|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.021|TWO_SIDED|80.0|0.06|0.22||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.22|0.06|0.021
91642982|NCT01569074|183178250|SUPERIORITY_OR_OTHER|||||||0.073||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.073
91642983|NCT01569074|183178250|SUPERIORITY_OR_OTHER|||||||0.065||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.065
91642984|NCT01569074|183178250|SUPERIORITY_OR_OTHER|||||||0.317||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.317
91676563|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-3.1|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.1|
91676564|NCT02037165|183248036|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.76|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-1.4|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.4|
91692328|NCT03656068|183279635|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.1||||0.7587|TWO_SIDED|95.0|-6.37|8.57||p-value for testing mean = 0|t-test, 2 sided|||||8.57|-6.37|0.7587
91527520|NCT01302938|182930335|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-1.0|1.83||||||Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.83|-1.00|
91676565|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.13|STANDARD_ERROR_OF_MEAN|3.2064|||TWO_SIDED|95.0|-12.5|0.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.2|-12.5|
91676566|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.88|STANDARD_ERROR_OF_MEAN|3.4032|||TWO_SIDED|95.0|-10.6|2.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.6|
91676567|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.67|STANDARD_ERROR_OF_MEAN|3.3393|||TWO_SIDED|95.0|-13.3|0.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.0|-13.3|
91676568|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|3.5727|||TWO_SIDED|95.0|-8.9|5.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.3|-8.9|
91676569|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.43|STANDARD_ERROR_OF_MEAN|3.1554|||TWO_SIDED|95.0|-10.7|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-10.7|
91676570|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.6161|||TWO_SIDED|95.0|-6.4|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.4|
91676571|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.35|STANDARD_ERROR_OF_MEAN|3.1849|||TWO_SIDED|95.0|-8.7|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-8.7|
91676572|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.78|STANDARD_ERROR_OF_MEAN|3.7688|||TWO_SIDED|95.0|-10.3|4.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-10.3|
91486545|NCT03673046|182845759|SUPERIORITY||Mean Difference (Final Values)|-5.8847|STANDARD_ERROR_OF_MEAN|1.676||0.0008|TWO_SIDED|95.0|-9.2237|-2.5458||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in SDS total scores between the treatment groups at endpoint (week 12).||-2.5458|-9.2237|.0008
91527521|NCT01302938|182930335|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-3.0|1.0||||||Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.00|-3.00|
91527522|NCT01302938|182930336|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.3|1.8||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.8|-1.3|
91486546|NCT03673046|182845760|SUPERIORITY||Mean Difference (Final Values)|11.7529|STANDARD_ERROR_OF_MEAN|3.4553||0.0011|TWO_SIDED|95.0|4.863|18.6428||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Q-LESQ-SF total scores between the treatment groups at endpoint (week 12).||18.6428|4.8630|.0011
91642985|NCT01569074|183178250|SUPERIORITY_OR_OTHER|||||||0.263||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.263
91676573|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.857|||TWO_SIDED|95.0|-7.0|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-7.0|
91676574|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.91|STANDARD_ERROR_OF_MEAN|3.1527|||TWO_SIDED|95.0|-13.2|-0.07|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-.07|-13.2|
91676575|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.22|STANDARD_ERROR_OF_MEAN|3.3457|||TWO_SIDED|95.0|-10.9|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-10.9|
91676576|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.61|STANDARD_ERROR_OF_MEAN|3.2806|||TWO_SIDED|95.0|-10.1|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.1|
91676577|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|3.5078|||TWO_SIDED|95.0|-7.8|6.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.2|-7.8|
91692329|NCT03656068|183279636|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.567||||0.3784|TWO_SIDED|95.0|-1.88|0.746||p-value for testing mean = 0|t-test, 2 sided|||||0.746|-1.880|0.3784
91692330|NCT03656068|183279637|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-4.64||||0.3526|TWO_SIDED|95.0|-14.8|5.53||p-value for testing mean = 0|t-test, 2 sided|||||5.53|-14.80|0.3526
91486547|NCT01896050|182845761|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients||||0.03
91527523|NCT01302938|182930336|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.2|0.9||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.9|-2.2|
91642986|NCT01569074|183178251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3||||0.033|TWO_SIDED|80.0|1.94|14.31|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||14.31|1.94|0.033
91642987|NCT01569074|183178251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.1||||0.033|TWO_SIDED|80.0|1.92|13.61|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||13.61|1.92|0.033
91527524|NCT01302938|182930339|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.8|1.9||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.9|-0.8|
91642988|NCT01569074|183178251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.257|TWO_SIDED|80.0|0.89|6.89|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||6.89|0.89|0.257
91642989|NCT01569074|183178251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.481|TWO_SIDED|80.0|0.63|5.04|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.04|0.63|0.481
91642990|NCT01569074|183178252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.131|TWO_SIDED|80.0|1.12|4.2|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.20|1.12|0.131
91642991|NCT01569074|183178252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.423|TWO_SIDED|80.0|0.79|2.82|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.82|0.79|0.423
91642992|NCT01569074|183178252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.781|TWO_SIDED|80.0|0.45|1.67|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.67|0.45|0.781
91642993|NCT01569074|183178252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.239|TWO_SIDED|80.0|0.95|3.44|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.44|0.95|0.239
91642994|NCT01569074|183178253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.169|TWO_SIDED|80.0|1.06|4.67||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ration \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.67|1.06|0.169
91642995|NCT01569074|183178253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|80.0|0.45|1.78||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.78|0.45|0.833
91642996|NCT01569074|183178253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.614|TWO_SIDED|80.0|0.37|1.54||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.54|0.37|0.614
91642997|NCT01569074|183178253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.748|TWO_SIDED|80.0|0.42|1.69||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.69|0.42|0.748
91642998|NCT01569074|183178254|SUPERIORITY_OR_OTHER||Treatment difference|3.01||||0.087|TWO_SIDED|80.0|0.76|5.26|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.26|0.76|0.087
91527525|NCT01302938|182930339|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-3.7|0.8||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.8|-3.7|
91486548|NCT01896050|182845761|SUPERIORITY_OR_OTHER||BMI squared|-0.01845|STANDARD_ERROR_OF_MEAN|0.02308||0.4262|TWO_SIDED||||||Regression, Linear|||Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.||||0.4262
91486549|NCT01896050|182845762|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients||||0.032
91527526|NCT01302938|182930339|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-6.3|0.4||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.4|-6.3|
91527527|NCT01302938|182930342|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.0|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|95.0|-33.2|13.2||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||13.2|-33.2|
91527528|NCT01302938|182930343|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.7|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-6.9|30.3||||||Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||30.3|-6.9|
91676578|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|3.0965|||TWO_SIDED|95.0|-6.2|6.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.1|-6.2|
91676579|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|2.5649|||TWO_SIDED|95.0|-6.1|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.1|
91676580|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.59|STANDARD_ERROR_OF_MEAN|3.125|||TWO_SIDED|95.0|-8.8|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-8.8|
91676581|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.84|STANDARD_ERROR_OF_MEAN|3.7013|||TWO_SIDED|95.0|-11.2|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-11.2|
91676582|NCT02037165|183248037|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.05|STANDARD_ERROR_OF_MEAN|2.8201|||TWO_SIDED|95.0|-8.7|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-8.7|
91676583|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.78|STANDARD_ERROR_OF_MEAN|2.5753|||TWO_SIDED|95.0|-8.9|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-8.9|
91676584|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.74|STANDARD_ERROR_OF_MEAN|2.5162|||TWO_SIDED|95.0|-9.8|0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.3|-9.8|
91692331|NCT03656068|183279638|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.098||||0.9218|TWO_SIDED|95.0|-1.978|2.173||p-value for testing mean = 0|t-test, 2 sided|||||2.173|-1.978|0.9218
91486550|NCT01896050|182845763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.92|1.04||||||Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.||1.04|0.92|
91486551|NCT03693300|182845777|OTHER||Proportion (%)|6.1|||||TWO_SIDED|95.0|2.5|12.24|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||12.24|2.50|
91717134|NCT04745351|183326745|SUPERIORITY|||||||0.8541||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.8541
91717135|NCT04745351|183326746|SUPERIORITY|||||||0.4974||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.4974
91717136|NCT04745351|183326747|SUPERIORITY|||||||0.4283||||||P-value was calculated based on Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||0.4283
91717137|NCT04745351|183326748|SUPERIORITY||Relative risk|0.89||||0.2773|TWO_SIDED|95.0|0.731|1.091||The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.091|0.731|0.2773
91486552|NCT03693300|182845777|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||70.76|0.00|
91642999|NCT01569074|183178254|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.881|TWO_SIDED|80.0|-1.91|2.41|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.41|-1.91|0.881
91486553|NCT03693300|182845777|OTHER||Proportion (%)|6.0|||||TWO_SIDED|95.0|2.44|11.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||11.94|2.44|
91486554|NCT03693300|182845777|OTHER||Proportion (%)|4.4|||||TWO_SIDED|95.0|1.44|9.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.94|1.44|
91486555|NCT03693300|182845777|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||70.76|0.00|
91486556|NCT03693300|182845777|OTHER||Proportion (%)|4.3|||||TWO_SIDED|95.0|1.4|9.69|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.69|1.40|
91486557|NCT02742441|182845786|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
91486558|NCT02742441|182845787|SUPERIORITY||||||<|0.001||||||Statistical significance was achieved for each of the clinical signs of psoriasis.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).||||<0.001
91486559|NCT02742441|182845788|SUPERIORITY|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
91486560|NCT00537238|182845792|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the difference in proportion (Pregabalin - Levetiracetam) was greater than -0.12.|Difference in Proportion|0.0|||||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
91486561|NCT00537238|182845793|SUPERIORITY_OR_OTHER_LEGACY||Median difference|4.1||||0.3571|TWO_SIDED|95.0|-2.6|10.9|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||10.9|-2.6|0.3571
91486562|NCT00537238|182845795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|TWO_SIDED||||||Fisher Exact|||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0822
91486563|NCT00537238|182845795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9175|TWO_SIDED||||||Fisher Exact|||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.9175
91717138|NCT04745351|183326749|SUPERIORITY||Relative risk|0.97||||0.7538|TWO_SIDED|95.0|0.819|1.155||The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.155|0.819|0.7538
91717139|NCT02014272|183326752|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.45|||||TWO_SIDED|90.0|92.07|98.94||||||Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||98.94|92.07|
91717140|NCT02014272|183326752|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.45|||||TWO_SIDED|90.0|99.33|107.75||||||Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||107.75|99.33|
91717141|NCT02014272|183326753|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.63|||||TWO_SIDED|90.0|83.13|101.01||||||Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||101.01|83.13|
91486564|NCT00537238|182845795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0483|TWO_SIDED||||||Fisher Exact|||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0483
91676585|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.06|STANDARD_ERROR_OF_MEAN|2.9156|||TWO_SIDED|95.0|-11.9|-0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.3|-11.9|
91527529|NCT01302938|182930343|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.0|STANDARD_ERROR_OF_MEAN|11.4|||TWO_SIDED|95.0|-16.7|32.7||||||Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||32.7|-16.7|
91676586|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.83|STANDARD_ERROR_OF_MEAN|3.4987|||TWO_SIDED|95.0|-13.8|0.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.1|-13.8|
91676587|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|STANDARD_ERROR_OF_MEAN|3.6922|||TWO_SIDED|95.0|-12.6|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-12.6|
91676588|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.71|STANDARD_ERROR_OF_MEAN|3.6166|||TWO_SIDED|95.0|-11.9|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-11.9|
91676589|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.09|STANDARD_ERROR_OF_MEAN|3.7073|||TWO_SIDED|95.0|-10.5|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-10.5|
91676590|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.82|STANDARD_ERROR_OF_MEAN|4.186|||TWO_SIDED|95.0|-12.1|4.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.5|-12.1|
91692332|NCT03656068|183279639|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.15||||0.9833|TWO_SIDED|95.0|-14.71|15.01||p-value for testing mean = 0|t-test, 2 sided|||||15.01|-14.71|0.9833
91692333|NCT03656068|183279640|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.68||||0.3957|TWO_SIDED|95.0|-17.79|43.16||p-value for testing mean = 0|t-test, 2 sided|||||43.16|-17.79|0.3957
91486565|NCT00537238|182845795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7139|TWO_SIDED||||||Fisher Exact|||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.7139
91486566|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.78||0.1334|TWO_SIDED|95.0|-0.36|2.69|||ANCOVA|||Baseline, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||2.69|-0.36|0.1334
91486567|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3551|TWO_SIDED|95.0|-0.19|0.52|||ANCOVA|||Baseline, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.52|-0.19|0.3551
91486568|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.46|STANDARD_ERROR_OF_MEAN|0.5||0.3638|TWO_SIDED|95.0|-1.45|0.53|||ANCOVA|||Change at Week 7, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.53|-1.45|0.3638
91527530|NCT01302938|182930343|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.3|STANDARD_ERROR_OF_MEAN|10.9|||TWO_SIDED|95.0|-13.3|33.8||||||Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||33.8|-13.3|
91717142|NCT02014272|183326753|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|107.58|||||TWO_SIDED|90.0|96.07|120.47||||||Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||120.47|96.07|
91717143|NCT02014272|183326754|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.92|||||TWO_SIDED|90.0|92.54|99.43||||||Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||99.43|92.54|
91717144|NCT02014272|183326754|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.41|||||TWO_SIDED|90.0|98.76|106.19||||||Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||106.19|98.76|
91717145|NCT03499795|183326759|SUPERIORITY|||||||0.8633|||||||Clopper-Pearson|P-value was calculated based on the exact method of Clopper-Pearson and superiority was concluded if the one-sided p-value is \<0.05.||||||0.8633
91717146|NCT02265510|183326771|OTHER|Descriptive Statistics|||||||||||||||||The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717147|NCT02265510|183326772|OTHER||||||||||||||||||Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
91486569|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.2457|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||Change at Week 7, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.34|0.2457
91486570|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.23|STANDARD_ERROR_OF_MEAN|0.53||0.664|TWO_SIDED|95.0|-1.26|0.81|||ANCOVA|||Change at Week 10, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.81|-1.26|0.6640
91717148|NCT02265510|183326773|OTHER||||||||||||||||||Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
91717149|NCT02265510|183326774|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717150|NCT02265510|183326775|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717151|NCT02265510|183326776|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717152|NCT02265510|183326777|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91527531|NCT01302938|182930343|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-11.0|29.0||||||Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||29.0|-11.0|
91717153|NCT02265510|183326778|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717154|NCT02265510|183326779|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717155|NCT02265510|183326780|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717156|NCT02265510|183326781|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
91717157|NCT02530385|183326794|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91717158|NCT02530385|183326795|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
91717159|NCT02530385|183326796|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
91717160|NCT02530385|183326797|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
91717161|NCT02530385|183326798|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
91717162|NCT03093181|183326804|SUPERIORITY||Least square (LS) mean difference|3.12||||0.0128|TWO_SIDED|95.0|0.68|5.56||From Analysis of covariance (ANCOVA) with treatment main effect, age stratum and baseline as covariates|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||5.56|0.68|0.0128
91717163|NCT03093181|183326804|SUPERIORITY||LS mean difference|1.51||||0.2262|TWO_SIDED|95.0|-0.95|3.96||From ANCOVA with treatment main effect, age stratum and baseline as covariates.|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||3.96|-0.95|0.2262
91717164|NCT03093181|183326806|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0243|TWO_SIDED|95.0|1.08|3.15|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||3.15|1.08|0.0243
91717165|NCT03093181|183326806|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8931|TWO_SIDED|95.0|0.61|1.78|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||1.78|0.61|0.8931
91717166|NCT03093181|183326806|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0181|TWO_SIDED|95.0|1.12|3.25|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||3.25|1.12|0.0181
91717167|NCT03093181|183326806|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8319|TWO_SIDED|95.0|0.55|1.63|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||1.63|0.55|0.8319
91717168|NCT03093181|183326807|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0279|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.28|0.02|0.0279
91486571|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.595|TWO_SIDED|95.0|-0.3|0.17|||ANCOVA|||Change at Week 10, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.17|-0.30|0.5950
91527532|NCT01302938|182930344|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-20.0|20.0||||||Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||20.00|-20.00|
91527533|NCT01811563|182930381|EQUIVALENCE|Main effect for implant independent of time||||||0.661|||||||ANOVA|||||||0.661
91527534|NCT01811563|182930381|EQUIVALENCE|Main effect for time independent of implant|||||<|0.001|||||||ANOVA|||||||<0.001
91527535|NCT01811563|182930381|EQUIVALENCE|Interaction between implant and time||||||0.27|||||||ANOVA|||||||0.270
91676591|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.67|STANDARD_ERROR_OF_MEAN|3.4254|||TWO_SIDED|95.0|-9.5|4.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.1|-9.5|
91676592|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.5461|||TWO_SIDED|95.0|-8.7|1.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.4|-8.7|
91676593|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.46|STANDARD_ERROR_OF_MEAN|2.4848|||TWO_SIDED|95.0|-7.4|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-7.4|
91676594|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.27|STANDARD_ERROR_OF_MEAN|2.8811|||TWO_SIDED|95.0|-9.0|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-9.0|
91676595|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.91|STANDARD_ERROR_OF_MEAN|3.4569|||TWO_SIDED|95.0|-9.8|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-9.8|
91676596|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.27|STANDARD_ERROR_OF_MEAN|3.6471|||TWO_SIDED|95.0|-7.0|7.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.5|-7.0|
91676597|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.27|STANDARD_ERROR_OF_MEAN|3.5708|||TWO_SIDED|95.0|-9.4|4.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.8|-9.4|
91692334|NCT03656068|183279641|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.81||||0.344|TWO_SIDED|95.0|-4.39|12.01||p-value for testing mean = 0|t-test, 2 sided|||||12.01|-4.39|0.3440
91692335|NCT03656068|183279642|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.22||||0.0607|TWO_SIDED|95.0|-0.77|31.21||p-value for testing mean = 0|t-test, 2 sided|||||31.21|-0.77|0.0607
91692336|NCT03656068|183279643|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.83||||0.0644|TWO_SIDED|95.0|-0.39|12.05||p-value for testing mean = 0|t-test, 2 sided|||||12.05|-0.39|0.0644
91692337|NCT03656068|183279644|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.3665||||0.0487|TWO_SIDED|95.0|-0.7306|-0.0023||p-value for testing mean = 0|t-test, 2 sided|||||-0.0023|-0.7306|0.0487
91527536|NCT01811563|182930382|EQUIVALENCE|Main effect for implant independent of time||||||0.856|||||||ANOVA|Main effect for implant, LQ-YBT Baseline to 52 weeks||||||0.856
91643000|NCT01569074|183178254|SUPERIORITY_OR_OTHER||Treatment difference|-0.42||||0.806|TWO_SIDED|80.0|-2.64|1.8|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.80|-2.64|0.806
91643001|NCT01569074|183178254|SUPERIORITY_OR_OTHER||Treatment difference|1.03||||0.548|TWO_SIDED|80.0|-1.17|3.23|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.23|-1.17|0.548
91643002|NCT01569074|183178255|SUPERIORITY_OR_OTHER||Treatment difference|3.12||||0.139|TWO_SIDED|80.0|0.42|5.82|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.82|0.42|0.139
91643003|NCT01569074|183178255|SUPERIORITY_OR_OTHER||Treatment difference|2.47||||0.223|TWO_SIDED|80.0|-0.13|5.07|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.07|-0.13|0.223
91643004|NCT01569074|183178255|SUPERIORITY_OR_OTHER||Treatment difference|-1.63||||0.432|TWO_SIDED|80.0|-4.3|1.04|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.04|-4.30|0.432
91643005|NCT01569074|183178255|SUPERIORITY_OR_OTHER||Treatment difference|1.45||||0.481|TWO_SIDED|80.0|-1.19|4.09|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.09|-1.19|0.481
91643006|NCT01139801|183178272|SUPERIORITY||Mean Difference (Final Values)|212.2||||0.037|TWO_SIDED|95.0|13.3|411.0|||t-test, 2 sided|||||411.0|13.3|0.037
91643007|NCT00962013|183178279|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin is 7%||||||0.0136|||||||Exact Binomial|||This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.||||0.0136
91643008|NCT00962013|183178281|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from HHS pre-op to HHS 5 year||||<0.0001
91643009|NCT00962013|183178282|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores||||<0.0001
91643010|NCT00962013|183178284|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Exact Binomial|||Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)||||<0.0001
91643011|NCT02222168|183178302|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|95.9|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|72.593|126.682|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||126.682|72.593|
91643012|NCT02222168|183178302|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|82.13|STANDARD_ERROR_OF_MEAN|38.0|||TWO_SIDED|90.0|66.37|101.639|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||101.639|66.370|
91643013|NCT02222168|183178303|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.697|119.318|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.318|96.697|
91692338|NCT03656068|183279645|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|16.64||||0.5919|TWO_SIDED|95.0|-47.25|80.54||p-value for testing mean = 0|t-test, 2 sided|||||80.54|-47.25|0.5919
91692339|NCT03656068|183279646|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2679||||0.1272|TWO_SIDED|95.0|-0.634|0.0983||p-value for testing mean = 0|t-test, 2 sided|||||0.0983|-0.6340|0.1272
91486572|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.31|STANDARD_ERROR_OF_MEAN|0.55||0.5701|TWO_SIDED|95.0|-1.38|0.76|||ANCOVA|||Change at Week 13, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.76|-1.38|0.5701
91486573|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2452|TWO_SIDED|95.0|-0.33|0.08|||ANCOVA|||Change at Week 13, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.08|-0.33|0.2452
91486574|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.77|STANDARD_ERROR_OF_MEAN|0.56||0.1697|TWO_SIDED|95.0|-1.88|0.33|||ANCOVA|||Change at Week 16, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.33|-1.88|0.1697
91486575|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.2283|TWO_SIDED|95.0|-0.36|0.09|||ANCOVA|||Change at Week 16, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.36|0.2283
91676598|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.21|STANDARD_ERROR_OF_MEAN|3.6602|||TWO_SIDED|95.0|-11.5|3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-11.5|
91486576|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.35|STANDARD_ERROR_OF_MEAN|0.61||0.0262|TWO_SIDED|95.0|-2.54|-0.16|||ANCOVA|||Change at Follow-up, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||-0.16|-2.54|0.0262
91486577|NCT00537238|182845796|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.26|STANDARD_ERROR_OF_MEAN|0.13||0.0495|TWO_SIDED|95.0|-0.52|0.0|||ANCOVA|||Change at Follow-up, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.00|-0.52|0.0495
91527537|NCT01811563|182930382|EQUIVALENCE|Time independent of implant, Baseline to 52 Weeks|||||<|0.001|||||||ANOVA|||||||<0.001
91527538|NCT01811563|182930382|EQUIVALENCE|Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker||||||0.822|||||||ANOVA|||||||0.822
91676599|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|4.1389|||TWO_SIDED|95.0|-7.7|8.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||8.8|-7.7|
91486578|NCT00537238|182845797|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.09|STANDARD_ERROR_OF_MEAN|0.37||0.8084|TWO_SIDED|95.0|-0.82|0.64|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.64|-0.82|0.8084
91676600|NCT02037165|183248038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|3.3835|||TWO_SIDED|95.0|-8.8|4.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-8.8|
91676601|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-29.67|STANDARD_ERROR_OF_MEAN|29.5691|||TWO_SIDED|95.0|-88.3|29.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.0|-88.3|
91676602|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-16.29|STANDARD_ERROR_OF_MEAN|29.8613|||TWO_SIDED|95.0|-75.5|42.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||42.9|-75.5|
91676603|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|7.63|STANDARD_ERROR_OF_MEAN|25.1035|||TWO_SIDED|95.0|-42.2|57.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||57.5|-42.2|
91676604|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-20.47|STANDARD_ERROR_OF_MEAN|23.311|||TWO_SIDED|95.0|-66.7|25.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||25.8|-66.7|
91676605|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-12.63|STANDARD_ERROR_OF_MEAN|23.1894|||TWO_SIDED|95.0|-58.6|33.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||33.4|-58.6|
91676606|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|23.7285|||TWO_SIDED|95.0|-47.8|46.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||46.5|-47.8|
91692340|NCT03656068|183279647|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.02||||0.5881|TWO_SIDED|95.0|-47.55|77.59||p-value for testing mean = 0|t-test, 2 sided|||||77.59|-47.55|0.5881
91692341|NCT03656068|183279648|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.18||||0.1458|TWO_SIDED|95.0|-0.42|0.07|||t-test, 2 sided|||||0.07|-0.42|0.1458
91527539|NCT01811563|182930383|EQUIVALENCE|Main effect for implant, Baseline to 52 weeks||||||0.158|||||||ANOVA|||||||.158
91486579|NCT00537238|182845797|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.22|STANDARD_ERROR_OF_MEAN|0.35||0.5263|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.91|-0.47|0.5263
91486580|NCT00537238|182845797|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.25|STANDARD_ERROR_OF_MEAN|0.3||0.4008|TWO_SIDED|95.0|-0.34|0.85|||ANCOVA|||Week 16, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.85|-0.34|0.4008
91486581|NCT00537238|182845797|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9749|TWO_SIDED|95.0|-0.61|0.59|||ANCOVA|||Week 16, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.59|-0.61|0.9749
91526677|NCT03661996|182928693|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.013|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.97|1.057|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.057|0.970|
91526678|NCT03661996|182928693|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.931|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.892|0.972|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||0.972|0.892|
91676607|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-19.27|STANDARD_ERROR_OF_MEAN|27.6359|||TWO_SIDED|95.0|-74.3|35.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||35.7|-74.3|
91676608|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-25.23|STANDARD_ERROR_OF_MEAN|27.5524|||TWO_SIDED|95.0|-79.9|29.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.5|-79.9|
91676609|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-17.19|STANDARD_ERROR_OF_MEAN|27.0135|||TWO_SIDED|95.0|-70.9|36.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||36.5|-70.9|
91676610|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.62|STANDARD_ERROR_OF_MEAN|29.3023|||TWO_SIDED|95.0|-97.7|18.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||18.5|-97.7|
91676611|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-37.06|STANDARD_ERROR_OF_MEAN|29.5797|||TWO_SIDED|95.0|-95.7|21.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||21.6|-95.7|
91692342|NCT03656068|183279649|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-11.53||||0.1495|TWO_SIDED|95.0|-27.61|4.54||p-value for testing mean = 0|t-test, 2 sided|||||4.54|-27.61|0.1495
91692343|NCT03656068|183279650|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.3174|TWO_SIDED|95.0|-0.4|0.15||p-value for testing mean = 0|t-test, 2 sided|||||0.15|-0.40|0.3174
91643014|NCT02222168|183178303|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.88|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.028|105.875|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.875|85.028|
91527540|NCT01811563|182930383|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
91643015|NCT02222168|183178304|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.709|119.301|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.301|96.709|
91643016|NCT02222168|183178304|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.92|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.061|105.921|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.921|85.061|
91643017|NCT00530621|183178305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.544||95.0|0.77|1.65||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.65|0.77|0.544
91643018|NCT00530621|183178306|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.171||95.0|0.42|1.17||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.17|0.42|0.171
91643019|NCT00530621|183178307|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11||||0.01||95.0|1.19|3.75|||Regression, Cox|||||3.75|1.19|0.010
91643020|NCT00530621|183178308|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.5||||0.194||95.0|0.81|2.77||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status score and time since last chemotherapy.|Log Rank|||||2.77|0.81|0.194
91676612|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-52.45|STANDARD_ERROR_OF_MEAN|24.8429|||TWO_SIDED|95.0|-101.8|-3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-3.1|-101.8|
91676613|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-59.87|STANDARD_ERROR_OF_MEAN|23.0541|||TWO_SIDED|95.0|-105.6|-14.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-14.1|-105.6|
91676614|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.96|STANDARD_ERROR_OF_MEAN|22.9336|||TWO_SIDED|95.0|-85.5|5.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.5|-85.5|
91676615|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-38.99|STANDARD_ERROR_OF_MEAN|23.4683|||TWO_SIDED|95.0|-85.6|7.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.6|-85.6|
91692344|NCT03656068|183279651|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.02||||0.242|TWO_SIDED|95.0|-22.86|6.82||p-value for testing mean = 0|t-test, 2 sided|||||6.82|-22.86|0.2420
91692345|NCT01436370|183279652|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain.||||0.145
91643021|NCT00530621|183178309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.681|||||||Fisher Exact|||||||0.681
91643022|NCT02596009|183178313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.97|||<|0.0001|TWO_SIDED|95.0|23.7|30.24|||paired t-test|||||30.24|23.70|<0.0001
91643023|NCT02596009|183178313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.93|||<|0.0001|TWO_SIDED|95.0|49.15|58.72|||paired t-test|||||58.72|49.15|<0.0001
91643024|NCT01281475|183178315|SUPERIORITY|We modeled each outcome variable as a function of treatment (ie, levodopa versus placebo), visit (ie, baseline vs. 12-month follow-up) and the treatment-by-visit interaction; the interaction term tests whether the effect of levodopa treatment over time is significantly greater than that of the placebo group.||||||0.75||||||This was the calculated p value without correction for multiple comparisons|Generalized estimating equations|||We performed generalized estimating equations with an unstructured covariance matrix to account for inter-correlations within measurements on the same participant over time.||||0.75
91643025|NCT04611152|183178317|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.84||0.4162|TWO_SIDED|95.04|-5.47|-2.17|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.17|-5.47|0.4162
91643026|NCT04611152|183178318|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
91643027|NCT04611152|183178319|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.0|||||TWO_SIDED|95.04|0.0|0.0|||||Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||0|0|
91643028|NCT01275170|183178331|OTHER|Geometric mean ratio (GMR) \[Renal Impairment/Healthy Control\]|GMR|1.63|||||TWO_SIDED|90.0|1.12|2.39||||||||2.39|1.12|
91643029|NCT01275170|183178331|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.19|||||TWO_SIDED|90.0|1.51|3.18||||||||3.18|1.51|
91643030|NCT01275170|183178331|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|4.87|||||TWO_SIDED|90.0|3.37|7.04||||||||7.04|3.37|
91643031|NCT01275170|183178331|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|9.32|||||TWO_SIDED|90.0|6.45|13.46||||||||13.46|6.45|
91643032|NCT01275170|183178331|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.76|||||TWO_SIDED|90.0|1.2|2.58||||||||2.58|1.20|
91643033|NCT01275170|183178332|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.1|||||TWO_SIDED|90.0|0.64|1.88||||||||1.88|0.64|
91643034|NCT01275170|183178332|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.04|||||TWO_SIDED|90.0|0.62|1.77||||||||1.77|0.62|
91526679|NCT03661996|182928694|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|17.15|STANDARD_ERROR_OF_MEAN|1.396|<|0.0001|TWO_SIDED|95.0|14.4|19.9|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||19.90|14.40|<0.0001
91643035|NCT01275170|183178332|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.3|||||TWO_SIDED|90.0|0.77|2.2||||||||2.20|0.77|
91643036|NCT01275170|183178332|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.34|||||TWO_SIDED|90.0|1.39|3.96||||||||3.96|1.39|
91643037|NCT01275170|183178332|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.85|||||TWO_SIDED|90.0|0.5|1.44||||||||1.44|0.50|
91643038|NCT01275170|183178333|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.42|0.9||||||||0.90|0.42|
91643039|NCT01275170|183178333|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.46|||||TWO_SIDED|90.0|0.31|0.66||||||||0.66|0.31|
91643040|NCT01275170|183178333|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.21|||||TWO_SIDED|90.0|0.14|0.3||||||||0.30|0.14|
91643041|NCT01275170|183178333|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.11|||||TWO_SIDED|90.0|0.07|0.16||||||||0.16|0.07|
91643042|NCT01275170|183178333|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.57|||||TWO_SIDED|90.0|0.39|0.84||||||||0.84|0.39|
91643043|NCT01275170|183178334|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
91643044|NCT01275170|183178334|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.84|1.22||||||||1.22|0.84|
91643045|NCT01275170|183178334|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.9|||||TWO_SIDED|90.0|0.74|1.08||||||||1.08|0.74|
91643046|NCT01275170|183178334|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.96|||||TWO_SIDED|90.0|0.79|1.16||||||||1.16|0.79|
91643047|NCT01275170|183178334|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.28|||||TWO_SIDED|90.0|2.7|4.0||||||||4.00|2.70|
91643048|NCT01275170|183178337|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.41|||||TWO_SIDED|90.0|1.07|1.84||||||||1.84|1.07|
91643049|NCT01275170|183178337|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.53|||||TWO_SIDED|90.0|1.17|1.99||||||||1.99|1.17|
91643050|NCT01275170|183178337|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.51|||||TWO_SIDED|90.0|1.93|3.26||||||||3.26|1.93|
91643051|NCT01275170|183178337|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.1|||||TWO_SIDED|90.0|2.39|4.03||||||||4.03|2.39|
91643052|NCT01275170|183178337|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.76|1.29||||||||1.29|0.76|
91643053|NCT01275170|183178338|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.15|||||TWO_SIDED|90.0|0.65|2.06||||||||2.06|0.65|
91643054|NCT01275170|183178338|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.61|1.89||||||||1.89|0.61|
91643055|NCT01275170|183178338|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.32|||||TWO_SIDED|90.0|0.75|2.32||||||||2.32|0.75|
91643056|NCT01275170|183178338|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.46|||||TWO_SIDED|90.0|1.4|4.33||||||||4.33|1.40|
91527541|NCT01811563|182930383|EQUIVALENCE|Interaction of time by implant, Baseline to 52 weeks||||||0.365|||||||ANOVA|||||||0.365
91643057|NCT01275170|183178338|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.86|||||TWO_SIDED|90.0|0.49|1.51||||||||1.51|0.49|
91643058|NCT01275170|183178339|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.71|||||TWO_SIDED|90.0|0.54|0.93||||||||0.93|0.54|
91643059|NCT01275170|183178339|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.65|||||TWO_SIDED|90.0|0.5|0.85||||||||0.85|0.50|
91643060|NCT01275170|183178339|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.4|||||TWO_SIDED|90.0|0.31|0.52||||||||0.52|0.31|
91643061|NCT01275170|183178339|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.32|||||TWO_SIDED|90.0|0.25|0.42||||||||0.42|0.25|
91643062|NCT01275170|183178339|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.78|1.31||||||||1.31|0.78|
91643063|NCT01275170|183178340|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.61|1.08||||||||1.08|0.61|
91643064|NCT01275170|183178340|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.95|||||TWO_SIDED|90.0|0.72|1.26||||||||1.26|0.72|
91643065|NCT01275170|183178340|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.61|1.06||||||||1.06|0.61|
91643066|NCT01275170|183178340|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.83|||||TWO_SIDED|90.0|0.63|1.09||||||||1.09|0.63|
91643067|NCT01275170|183178340|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.54|||||TWO_SIDED|90.0|1.93|3.36||||||||3.36|1.93|
91692346|NCT01436370|183279652|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain||||0.145
91643068|NCT01275170|183178343|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.6|||||TWO_SIDED|90.0|1.03|2.49||||||||2.49|1.03|
91643069|NCT01275170|183178343|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.86|||||TWO_SIDED|90.0|1.21|2.87||||||||2.87|1.21|
91643070|NCT01275170|183178343|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|5.6|||||TWO_SIDED|90.0|3.64|8.59||||||||8.59|3.64|
91643071|NCT01275170|183178343|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|13.75|||||TWO_SIDED|90.0|8.96|21.12||||||||21.12|8.96|
91643072|NCT01275170|183178343|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.64|||||TWO_SIDED|90.0|2.32|5.69||||||||5.69|2.32|
91643073|NCT01275170|183178344|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.25|||||TWO_SIDED|90.0|0.75|2.08||||||||2.08|0.75|
91643074|NCT01275170|183178344|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.13|||||TWO_SIDED|90.0|0.69|1.87||||||||1.87|0.69|
91643075|NCT01275170|183178344|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.49|||||TWO_SIDED|90.0|0.9|2.44||||||||2.44|0.90|
91643076|NCT01275170|183178344|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.49|||||TWO_SIDED|90.0|1.51|4.09||||||||4.09|1.51|
91643077|NCT01275170|183178344|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.94|||||TWO_SIDED|90.0|0.57|1.54||||||||1.54|0.57|
91643078|NCT01275170|183178345|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.4|0.97||||||||0.97|0.40|
91643079|NCT01275170|183178345|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.54|||||TWO_SIDED|90.0|0.35|0.83||||||||0.83|0.35|
91643080|NCT01275170|183178345|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.18|||||TWO_SIDED|90.0|0.12|0.27||||||||0.27|0.12|
91643081|NCT01275170|183178345|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.07|||||TWO_SIDED|90.0|0.05|0.11||||||||0.11|0.05|
91643082|NCT01275170|183178345|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.27|||||TWO_SIDED|90.0|0.18|0.43||||||||0.43|0.18|
91643083|NCT01275170|183178346|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.04||||||||1.04|0.62|
91527542|NCT01811563|182930385|EQUIVALENCE|Main effect for implant, baseline to 52 weeks||||||0.416|||||||ANOVA|||||||.416
91643084|NCT01275170|183178346|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.71|1.17||||||||1.17|0.71|
91643085|NCT01275170|183178346|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.03||||||||1.03|0.62|
91643086|NCT01275170|183178346|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.76|||||TWO_SIDED|90.0|0.59|0.97||||||||0.97|0.59|
91643087|NCT01275170|183178346|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.81|||||TWO_SIDED|90.0|2.16|3.65||||||||3.65|2.16|
91643088|NCT01275170|183178352|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.52|||||TWO_SIDED|90.0|1.07|2.15||||||||2.15|1.07|
91643089|NCT01275170|183178352|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.45|0.9||||||||0.90|0.45|
91643090|NCT01275170|183178352|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.67|||||TWO_SIDED|90.0|0.47|0.94||||||||0.94|0.47|
91643091|NCT01275170|183178353|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.63|1.83||||||||1.83|0.63|
91643092|NCT01275170|183178353|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.6|||||TWO_SIDED|90.0|0.35|1.01||||||||1.01|0.35|
91643093|NCT01275170|183178353|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.36|1.04||||||||1.04|0.36|
91643094|NCT01275170|183178354|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.47|||||TWO_SIDED|90.0|0.63|3.4||||||||3.40|0.63|
91643095|NCT01275170|183178354|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.41|2.0||||||||2.00|0.41|
91643096|NCT01275170|183178354|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.37|1.78||||||||1.78|0.37|
91643097|NCT04755283|183178387|SUPERIORITY||Hazard Ratio (HR)|0.314|||<|0.001|TWO_SIDED|95.0|0.192|0.513|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.513|0.192|<0.001
91643098|NCT04755283|183178387|SUPERIORITY||Hazard Ratio (HR)|0.382|||<|0.001|TWO_SIDED|95.0|0.243|0.602|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.602|0.243|<0.001
91643099|NCT04755283|183178388|SUPERIORITY||Hazard Ratio (HR)|0.263|||<|0.001|TWO_SIDED|95.0|0.121|0.572|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.572|0.121|<0.001
91692347|NCT01436370|183279652|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.999
91643100|NCT04755283|183178388|SUPERIORITY||Hazard Ratio (HR)|0.325||||0.001|TWO_SIDED|95.0|0.159|0.663|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.663|0.159|0.001
91643101|NCT04755283|183178389|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.332|0.638|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.638|0.332|<0.001
91676616|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-63.69|STANDARD_ERROR_OF_MEAN|27.3484|||TWO_SIDED|95.0|-118.1|-9.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-9.3|-118.1|
91676617|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-61.36|STANDARD_ERROR_OF_MEAN|27.2866|||TWO_SIDED|95.0|-115.6|-7.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-7.2|-115.6|
91676618|NCT02037165|183248039|SUPERIORITY_OR_OTHER||adjusted mean difference|-49.4|STANDARD_ERROR_OF_MEAN|26.7541|||TWO_SIDED|95.0|-102.6|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-102.6|
91676619|NCT04932941|183248046|SUPERIORITY||Common risk difference|-0.276||||0.962|TWO_SIDED|95.0|-11.634|11.081|||Mantel Haenszel||Strata-adjusted Mantel Haenszel (MH) method for difference in proportions controlling for stratification factors (COVID-19 severity: moderate, severe, and age group: less than or equal to 65 years, greater than 65 years).|||11.081|-11.634|0.962
91676620|NCT00375492|183248115|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Model Repeated Measures|||||||0.0030
91676621|NCT00375492|183248116|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures|||||||<0.0001
91676622|NCT00375492|183248118|SUPERIORITY_OR_OTHER|||||||0.1985||95.0|||||Mixed Model Repeated Measures|||||||0.1985
91676623|NCT00375492|183248119|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||ANCOVA|||||||0.1827
91676624|NCT00375492|183248120|SUPERIORITY_OR_OTHER|||||||0.1584||95.0|||||ANCOVA|||||||0.1584
91717169|NCT03093181|183326807|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8887|TWO_SIDED|95.0|-0.12|0.14|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.14|-0.12|0.8887
91717170|NCT03093181|183326807|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0224|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.28|0.02|0.0224
91717171|NCT03093181|183326807|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8253|TWO_SIDED|95.0|-0.15|0.12|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.12|-0.15|0.8253
91676625|NCT00375492|183248121|SUPERIORITY_OR_OTHER|||||||0.8279||95.0|||||ANCOVA|||||||0.8279
91676626|NCT00375492|183248122|SUPERIORITY_OR_OTHER|||||||0.8334||95.0|||||ANCOVA|||||||0.8334
91676627|NCT00375492|183248123|SUPERIORITY_OR_OTHER|||||||0.2881||95.0|||||ANCOVA|||||||0.2881
91717172|NCT00324155|183326816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.4067|TWO_SIDED|95.0|0.799|1.74|||Cochran-Mantel-Haenszel|Stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and ECOG performance status (0 vs 1) recorded at randomization.||Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) recorded at randomization.||1.740|0.799|0.4067
91643102|NCT04755283|183178389|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.01|TWO_SIDED|95.0|0.512|0.912|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.912|0.512|0.010
91676628|NCT00375492|183248124|SUPERIORITY_OR_OTHER|||||||0.0654||95.0|||||ANCOVA|||||||0.0654
91676629|NCT00375492|183248125|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Cochran-Mantel-Haenszel|||||||0.728
91676630|NCT00375492|183248126|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||ANOVA|||||||0.127
91676631|NCT01461226|183248150|OTHER|Mixed models analysis|mixed models|0.04|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91676632|NCT01461226|183248150|OTHER||mixed models|0.24||||0.64|TWO_SIDED|||||Baseline difference between groups|Mixed Models Analysis|||||||0.64
91676633|NCT01461226|183248150|OTHER|Mixed models|Slope|0.27||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
91676634|NCT01461226|183248150|OTHER|mixed models|mixed models|4.2||||0.04|TWO_SIDED||||||Mixed Models Analysis|||change after 10 months between groups||||0.04
91676635|NCT00609518|183248153|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.28|||Linear probability model|||||0.28|-0.10|
91676636|NCT00609518|183248154|SUPERIORITY_OR_OTHER|||||||0.4902||95.0|||||Fisher Exact|||||||0.4902
91676637|NCT00609518|183248155|SUPERIORITY_OR_OTHER|||||||0.6791||95.0|||||Log Rank|||||||0.6791
91676638|NCT00609518|183248155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.54|1.49|||Regression, Cox|Treatment was the covariate included in this model.||||1.49|0.54|
91676639|NCT00609518|183248156|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Log Rank|||||||0.5870
91717173|NCT00324155|183326824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0009|TWO_SIDED|95.0|0.588|0.872||p-value was via stratified log-rank test|Log Rank||Hazard ratio via stratified Cox proportional hazards model.|Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group performance status (0 vs 1) recorded at randomization.||0.872|0.588|0.0009
91717174|NCT05412134|183326852|OTHER|||||||0.333|||||||Chi-squared|||Repetition adherence||||0.333
91717175|NCT05412134|183326852|OTHER|||||||0.626|||||||Chi-squared|||Session adherence||||0.626
91717176|NCT05412134|183326853|SUPERIORITY|||||||0.416|||||||Wilcoxon (Mann-Whitney)|||||||0.416
91717177|NCT05412134|183326854|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||||||0.581
91717178|NCT05412134|183326855|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||||||0.071
91717179|NCT05412134|183326856|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
91717180|NCT05412134|183326858|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
91717181|NCT03444584|183326877|SUPERIORITY||LS mean difference|-143.09|||<|0.0001|TWO_SIDED|95.0|-198.2|-87.98|||ANCOVA|||||-87.98|-198.20|<0.0001
91717182|NCT03444584|183326878|SUPERIORITY||LS mean difference|-22.17|||<|0.0001|TWO_SIDED|95.0|-30.24|-14.1|||ANCOVA|||||-14.10|-30.24|<0.0001
91717183|NCT02439164|183326942|SUPERIORITY||Mean Difference (Net)|23.51|||<|0.01|TWO_SIDED|95.0|14.16|32.87|||t-test, 2 sided|bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.|this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.||Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,|32.87|14.16|<0.01
91717184|NCT02314728|183326947|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91717185|NCT02314728|183326948|SUPERIORITY|||||||0.6|||||||Fisher Exact|||NICU admission||||0.60
91717186|NCT02314728|183326948|SUPERIORITY|||||||0.13|||||||Fisher Exact|||histologic chorioamnionitis||||0.13
91717187|NCT02343224|183326950|OTHER||Kaplan-Meier estimate|76.2|||||TWO_SIDED|95.0|52.1|100.0||||||This Kaplan-Meier estimate is the conditional probability of event-free survival among study participants at 12 and 24 months.||100|52.1|
91526680|NCT03661996|182928694|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Mean Difference (Final Values)|20.41|STANDARD_ERROR_OF_MEAN|3.692|<|0.0001|TWO_SIDED|95.0|12.79|28.03|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||28.03|12.79|<0.0001
91717188|NCT02343224|183326951|OTHER||Kaplan-Meier estimate|75.0|||||TWO_SIDED|95.0|50.3|100.0||||||This Kaplan-Meier estimate is the conditional probability of overall survival among participants at 12 and 24 months.||100|50.3|
91717189|NCT03118934|183326952|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).|LSM Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|95.0||-0.1||||||||-0.1||
91717190|NCT03886272|183326966|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|112.96||||0.0413|TWO_SIDED|90.0|102.7|124.26||P-value for ratio outside 80% -125%.|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as: T1/R1. Intra-individual geometric coefficient of variation (gCV) = 14.2|Relative bioavailability||124.26|102.70|0.0413
91527543|NCT01811563|182930385|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
91527544|NCT01811563|182930385|EQUIVALENCE|Implant by time interaction, baseline to 52 weeks||||||0.917|||||||ANOVA|||||||0.917
91717191|NCT03886272|183326966|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|115.49||||0.0776|TWO_SIDED|90.0|105.23|126.74||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.9.|Relative bioavailability||126.74|105.23|0.0776
91717192|NCT03886272|183326966|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|78.05||||0.6443|TWO_SIDED|90.0|69.71|87.38||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as Tc3/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||87.38|69.71|0.6443
91717193|NCT03886272|183326966|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|45.97||||1|TWO_SIDED|90.0|41.05|51.48||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||51.48|41.05|1.00
91717194|NCT03886272|183326967|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|144.62||||0.9485|TWO_SIDED|90.0|124.82|167.57||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 22.1|Relative bioavailability||167.57|124.82|0.9485
91717195|NCT03886272|183326967|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|129.69||||0.7813|TWO_SIDED|90.0|119.51|140.73||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted geometric mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 12.2.|Relative Bioavailability||140.73|119.51|0.7813
91717196|NCT03886272|183326967|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|75.09||||0.7616|TWO_SIDED|90.0|64.58|87.32||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/3. Intra-individual geometric coefficient of variation (gCV) = 23.5.|Relative Bioavailability||87.32|64.58|0.7616
91717197|NCT03886272|183326967|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|41.45||||1|TWO_SIDED|90.0|35.61|48.25||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3u/R3. Intra-individual geometric coefficient of variation = 23.5.|Relative Bioavailability||48.25|35.61|1.00
91717198|NCT03886272|183326968|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|111.11|STANDARD_DEVIATION|11.5||0.0092|TWO_SIDED|90.0|102.87|120.01||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||120.01|102.87|0.0092
91717199|NCT03886272|183326968|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|114.13||||0.0442|TWO_SIDED|90.0|104.58|124.56||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.0.|Relative Bioavailability||124.56|104.58|0.0442
91717200|NCT03886272|183326968|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|80.1||||0.4928|TWO_SIDED|90.0|71.54|89.68||P-value for ratio outside 80% - 125%|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||89.68|71.54|0.4928
91717201|NCT03886272|183326968|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|48.83||||1|TWO_SIDED|90.0|43.6|54.69||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||54.69|43.60|1.00
91717202|NCT01091246|183326970|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5.|Ratio of geometric mean|1.07|||||TWO_SIDED|95.0|0.98|1.16|||Bootstrapping|||A/H1N1: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H1N1 strain||1.16|0.98|
91717203|NCT01091246|183326970|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.94|1.14|||Bootstrapping|||A/H3N2: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H3N2 strain||1.14|0.94|
91717204|NCT01091246|183326970|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.21|||||TWO_SIDED|95.0|1.07|1.37||||||B/Yamagata: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata) / (Q/LAIV) for B/Yamagata strain||1.37|1.07|
91717205|NCT01091246|183326970|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% confidence intervals were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.05|||||TWO_SIDED|95.0|0.93|1.18||||||B/Victoria: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Victoria) / (Q/LAIV) for B/Victoria strain||1.18|0.93|
91717206|NCT02848664|183327090|OTHER|Same DOSS score before and after device use for 3 months or improved DOSS score after device use for 3 months|||||<|0.025||||||p values adjusted for multiple comparisons (two outcome measures)|Wilcoxon (Mann-Whitney)|||Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.||||<0.025
91717207|NCT02848664|183327091|EQUIVALENCE|Examination of whether the level of swallowing handicap is changed following device use|Mean Difference (Net)|22.571||||0.016|TWO_SIDED|95.0|6.003|39.14|||t-test, 2 sided|||||39.140|6.003|0.016
91527545|NCT01811563|182930387|EQUIVALENCE|Main effect by implant, Baseline to 52 weeks||||||0.83|||||||ANOVA|||||||0.830
91527546|NCT01811563|182930387|EQUIVALENCE|Main effect by time, baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
91643103|NCT03743571|183178412|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
91643104|NCT03743571|183178413|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
91643105|NCT03743571|183178414|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
91643106|NCT03743571|183178415|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
91643107|NCT03743571|183178416|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
91643108|NCT03743571|183178417|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
91676640|NCT00609518|183248156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.57|1.38|||Regression, Cox|Treatment was the covariate included in this model.||||1.38|0.57|
91676641|NCT02920918|183248174|SUPERIORITY|||||||0.083|||||||ANOVA|||We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).||||0.083
91676642|NCT02920918|183248175|SUPERIORITY|||||||0.51|||||||ANOVA|||||||0.51
91676643|NCT00450619|183248207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.041|TWO_SIDED|95.0|||||Log Rank|||||||0.041
91526681|NCT03661996|182928694|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.05|STANDARD_ERROR_OF_MEAN|0.819|<|0.0001|TWO_SIDED|95.0|18.44|21.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||21.66|18.44|<0.0001
91643109|NCT03743571|183178418|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.67||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.19, p = .67||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.67
91643110|NCT03743571|183178419|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.96||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) \< .01, p = .96||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.96
91676644|NCT00450619|183248207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.046|TWO_SIDED|95.0|||||Hazard Ratio|||||||0.046
91526682|NCT03661996|182928694|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|18.4|STANDARD_ERROR_OF_MEAN|1.011|<|0.0001|TWO_SIDED|95.0|16.41|20.38|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||20.38|16.41|<0.0001
91676645|NCT00450619|183248211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.3|TWO_SIDED|95.0|0.37|1.35|||Kaplan Meier|||||1.35|0.37|0.30
91676646|NCT04442490|183248278|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0141|TWO_SIDED|95.0|-3.1|-0.3|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||-0.3|-3.1|0.0141
91676647|NCT04442490|183248279|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.1193|TWO_SIDED|95.0|-0.4|0.0|||MMRM||Model used was the MMRM with treatment (SAGE-217 or placebo), baseline CGI-S score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||0.0|-0.4|0.1193
91676648|NCT04442490|183248280|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-4.0|-2.0|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 3||-2.0|-4.0|<0.0001
91676649|NCT04442490|183248280|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-3.8|-1.4|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 8||-1.4|-3.8|<0.0001
91676650|NCT04442490|183248280|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.76||0.2344|TWO_SIDED|95.0|-2.4|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 42||0.6|-2.4|0.2344
91676651|NCT04442490|183248281|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0599|TWO_SIDED|95.0|0.99|1.98|||Generalized Estimating Equation Model|||Day 15|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.98|0.99|0.0599
91676652|NCT04442490|183248281|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94|||GEE Model|||Day 42|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure.Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.94|0.95|0.0889
91676653|NCT04442490|183248282|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5495|TWO_SIDED|95.0|0.76|1.66|||GEE Model|||Day 15|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.66|0.76|0.5495
91676654|NCT04442490|183248282|SUPERIORITY||Odds Ratio (OR)|1.09||||0.679|TWO_SIDED|95.0|0.74|1.6|||GEE Model|||Day 42|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.60|0.74|0.6790
91692348|NCT01436370|183279660|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain||||0.182
91692349|NCT01436370|183279660|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.||||0.500
91676655|NCT04442490|183248283|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0191|TWO_SIDED|95.0|1.07|2.16|||GEE Model|||Placebo, SAGE-217|Model used was a GEE for binary response model, with factors for treatment, CGI-S baseline score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having CGI-I response for participants treated with SAGE-217 relative to that for participants treated with placebo.|2.16|1.07|0.0191
91676656|NCT04442490|183248284|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.05||0.0238|TWO_SIDED|95.0|-4.4|-0.3|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline MADRS total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure|Placebo, SAGE-217||-0.3|-4.4|0.0238
91676657|NCT04442490|183248285|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0199|TWO_SIDED|95.0|-2.5|-0.2|||MMRM||Model used was MMRM with treatment (SAGE-217/placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Placebo, SAGE-217||-0.2|-2.5|0.0199
91676658|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.5||0.3216|TWO_SIDED|95.0|-0.5|1.5|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 8||1.5|-0.5|0.3216
91676659|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1247|TWO_SIDED|95.0|-0.2|1.8|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 15||1.8|-0.2|0.1247
91676660|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1111|TWO_SIDED|95.0|-0.2|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 28||2.0|-0.2|0.1111
91676661|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.59||0.1449|TWO_SIDED|95.0|-0.3|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 42||2.0|-0.3|0.1449
91676662|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8242|TWO_SIDED|95.0|-1.3|1.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Role-Physical Domain Score: Change from Baseline at Day 8||1.0|-1.3|0.8242
91676663|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8329|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 15||1.1|-1.4|0.8329
91676664|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8127|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 28||1.1|-1.4|0.8127
91676665|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.64||0.5435|TWO_SIDED|95.0|-0.9|1.6|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 42||1.6|-0.9|0.5435
91676666|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.3551|TWO_SIDED|95.0|-0.7|1.8|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 8||1.8|-0.7|0.3551
91676667|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7495|TWO_SIDED|95.0|-1.1|1.6|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 15||1.6|-1.1|0.7495
91676668|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.6471|TWO_SIDED|95.0|-1.1|1.7|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 28||1.7|-1.1|0.6471
91676669|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1832|TWO_SIDED|95.0|-0.5|2.5|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 42||2.5|-0.5|0.1832
91676670|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.5||0.0168|TWO_SIDED|95.0|0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 8||2.2|0.2|0.0168
91676671|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0787|TWO_SIDED|95.0|-0.1|2.0|||MMRM|||General Health Domain Score: Change from Baseline at Day 15||2.0|-0.1|0.0787
91676672|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4273|TWO_SIDED|95.0|-0.7|1.6|||MMRM|||General Health Domain Score: Change from Baseline at Day 28||1.6|-0.7|0.4273
91676673|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.0938|TWO_SIDED|95.0|-0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 42||2.2|-0.2|0.0938
91676674|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.88||0.0033|TWO_SIDED|95.0|0.9|4.3|||MMRM|||Vitality Domain Score: Change from Baseline at Day 8||4.3|0.9|0.0033
91717208|NCT02848664|183327092|EQUIVALENCE|whether the degree of laryngeal elevation relative to hyoid elevation became greater or less after device use for 3 months||||||0.046|||||||t-test, 2 sided|||||||0.046
91527547|NCT01811563|182930387|EQUIVALENCE|Interaction between implant and time, baseline to 52 weeks||||||0.728|||||||ANOVA|||||||0.728
91676675|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.0029|TWO_SIDED|95.0|1.1|5.1|||MMRM|||Vitality Domain Score: Change from Baseline at Day 15||5.1|1.1|0.0029
91676676|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.04||0.0791|TWO_SIDED|95.0|-0.2|3.9|||MMRM|||Vitality Domain Score: Change from Baseline at Day 28||3.9|-0.2|0.0791
91717209|NCT02848664|183327093|EQUIVALENCE|pairwise comparison within subject comparing baseline with 3 months post device use|Mean Difference (Final Values)|-52.78||||0.037|TWO_SIDED|95.0|-100.751|-4.809|||ANOVA|||||-4.809|-100.751|0.037
91643111|NCT03743571|183178420|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham),||||||0.43||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.65, p = .43||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.43
91676677|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.12||0.0761|TWO_SIDED|95.0|-0.2|4.2|||MMRM|||Vitality Domain Score: Change from Baseline at Day 42||4.2|-0.2|0.0761
91676678|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.91||0.1568|TWO_SIDED|95.0|-0.5|3.1|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 8||3.1|-0.5|0.1568
91676679|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2807|TWO_SIDED|95.0|-0.9|3.0|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 15||3.0|-0.9|0.2807
91676680|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7751|TWO_SIDED|95.0|-1.8|2.4|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 28||2.4|-1.8|0.7751
91676681|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.07||0.0913|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 42||3.9|-0.3|0.0913
91676682|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.05||0.2863|TWO_SIDED|95.0|-0.9|3.2|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 8||3.2|-0.9|0.2863
91676683|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1801|TWO_SIDED|95.0|-0.7|3.7|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 15||3.7|-0.7|0.1801
91676684|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.16||0.1107|TWO_SIDED|95.0|-0.4|4.1|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 28||4.1|-0.4|0.1107
91676685|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.3274|TWO_SIDED|95.0|-1.2|3.6|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 42||3.6|-1.2|0.3274
91643112|NCT04115488|183178426|EQUIVALENCE|Data was analyzed using a negative binomial model with a logarithmic link function and fixed effects for the treatment group and stratification factors. Equivalence was tested based 95% confidence interval.|Exponentiated Difference|0.17|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.613|0.944|||||Difference calculated as Tysabri minus PB006.|||0.944|-0.613|
91643113|NCT00972309|183178467|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91643114|NCT05554471|183178504|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: the time to ambulation for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used.||||<0.001
91643115|NCT05554471|183178505|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: the time to hemostasis for the MYNX CONTROL™ Venous VCD device is at least 5 minutes less than manual compression.||||<0.001
91643116|NCT05554471|183178507|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: The time to discharge eligibility for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used||||<0.001
91643117|NCT02062385|183178521|SUPERIORITY_OR_OTHER||1 - (Incidence V260 / Incidence Placebo)|69.3|||<|0.001|TWO_SIDED|95.0|54.5|79.7|||Clopper-Pearson|To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.||V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is \>0% at the final analysis||79.7|54.5|<0.001
91676686|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.93||0.0873|TWO_SIDED|95.0|-0.2|3.4|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 8||3.4|-0.2|0.0873
91676687|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.05||0.0871|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 15||3.9|-0.3|0.0871
91676688|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.12||0.3095|TWO_SIDED|95.0|-1.1|3.3|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 28||3.3|-1.1|0.3095
91676689|NCT04442490|183248287|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.1477|TWO_SIDED|95.0|-0.6|4.0|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 42||4.0|-0.6|0.1477
91676690|NCT04442490|183248288|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57||0.0828|TWO_SIDED|95.0|-2.1|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 8||0.1|-2.1|0.0828
91676691|NCT04442490|183248288|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0606|TWO_SIDED|95.0|-2.4|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 15||0.1|-2.4|0.0606
91717210|NCT01257347|183327118|SUPERIORITY_OR_OTHER||||||<=|0.001||||||We included a stopping rule in which recruitment would be stopped at the midpoint for futility if the z-score was negative or for efficacy if the z-score was positive and the p-value ≤ 0.001.|GEE model|GEE models (logit link) with clinician as the cluster variable, appropriateness of management as outcome, intervention group as explanatory variable.||The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.||||<=0.001
91676692|NCT04442490|183248288|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63||0.1079|TWO_SIDED|95.0|-2.3|0.2|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 28||0.2|-2.3|0.1079
91676693|NCT04442490|183248288|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.3951|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 42||0.7|-1.9|0.3951
91676694|NCT02836496|183248295|SUPERIORITY|||||||0.002||||||Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region|Cochran-Mantel-Haenszel|||||||0.002
91676695|NCT02836496|183248295|SUPERIORITY||Odds Ratio (OR)|0.28||||0.003|TWO_SIDED|95.0|0.12|0.64|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region.|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.64|0.12|0.003
91676696|NCT02836496|183248296|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region||||||0.020
91676697|NCT02836496|183248296|SUPERIORITY||Odds Ratio (OR)|0.33||||0.022|TWO_SIDED|95.0|0.13|0.85|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.85|0.13|0.022
91676698|NCT02836496|183248297|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.002|TWO_SIDED|95.0|0.18|0.67||Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.|Regression, Cox||Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio \<1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.|||0.67|0.18|0.002
91676699|NCT02836496|183248298|SUPERIORITY||Rate Ratio|0.34||||0.002|TWO_SIDED|95.0|0.19|0.63|||Wilcoxon Rank Sum Test|Wilcoxon test stratified by Baseline OCS (0-\<=20 mg/day, \>20 mg/day prednisone or equivalent) and region.|Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio \<1 indicates a lower flare rate with Mepolizumab compared with Placebo.|||0.63|0.19|0.002
91676700|NCT02836496|183248299|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Test|P-value was calculated using Wilcoxon Rank Sum Test||||||0.036
91676701|NCT00063635|183248303|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.26
91676702|NCT00063635|183248303|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.83
91676703|NCT00063635|183248304|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANCOVA|||||||0.32
91676704|NCT00063635|183248304|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||||||0.29
91676705|NCT00063635|183248305|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
91676706|NCT00063635|183248305|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
91676707|NCT00063635|183248306|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||||||0.71
91676708|NCT00063635|183248306|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared|||||||0.72
91676709|NCT00063635|183248307|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||0.18
91676710|NCT00063635|183248307|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Chi-squared|||||||0.25
91676711|NCT00063635|183248308|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared|||||||0.89
91676712|NCT00063635|183248308|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
91676713|NCT00063635|183248309|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
91676714|NCT00063635|183248309|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
91676715|NCT00063635|183248310|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||ANCOVA|||||||0.77
91676716|NCT00063635|183248310|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
91676717|NCT00063635|183248311|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91676718|NCT00063635|183248311|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||||||0.44
91676719|NCT00063635|183248312|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
91676720|NCT00063635|183248312|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||||||0.63
91676721|NCT00063635|183248313|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||||||0.15
91676722|NCT00063635|183248313|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||||||0.96
91676723|NCT00415194|183248314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.082|TWO_SIDED|95.0|0.75|1.02|||Stratified Log Rank|||||1.02|0.75|0.082
91676724|NCT00415194|183248315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.166|TWO_SIDED|95.0|0.76|1.03|||Stratified Log Rank|||||1.03|0.76|0.166
91527548|NCT01811563|182930388|EQUIVALENCE|Between implants at 6 weeks||||||0.319|||||||t-test, 2 sided|||||||0.319
91676725|NCT00415194|183248316|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Unadjusted normal distribution|p-value is based on an unadjusted, normal distribution approximation for differences in rates.||||||0.061
91526683|NCT03661996|182928695|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.45|STANDARD_ERROR_OF_MEAN|1.478|<|0.0001|TWO_SIDED|95.0|19.54|25.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.37|19.54|<0.0001
91676726|NCT00415194|183248317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.811|TWO_SIDED|95.0|0.56|1.53|||Stratified Log Rank|||||1.53|0.56|0.811
91717211|NCT03044314|183327181|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||Null hypothesis: inhalation with iNO (the gold standard) would provide greater response than the comparator (iloprost).||||0.148
91717212|NCT03044314|183327183|SUPERIORITY|||||||0.346|||||||Fisher Exact|||Null hypothesis was that fewer patients receiving iloprost (new agent) would respond compared to iNO (the gold standard).||||0.346
91717213|NCT00264147|183327202|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||<0.001
91717214|NCT00264147|183327202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||0.057
91717215|NCT00264147|183327202|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|18.53||||||95.0|7.84|28.65|||||CI based on the Wilson's score method.|||28.65|7.84|
91676727|NCT00415194|183248318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.2|TWO_SIDED|95.0|0.69|1.07|||Stratified Log Rank|||||1.07|0.69|0.20
91527549|NCT04249336|182930404|SUPERIORITY||Mean Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
91676728|NCT01297465|183248320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.947|||TWO_SIDED|95.0|-3.15|0.59|||ANOVA|ANOVA model adjusted for treatment and country|The primary efficacy variable was to be analyzed using an analysis of variance (ANOVA) model, adjusted for treatment and country.|The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®||0.59|-3.15|
91676729|NCT01524679|183248350|SUPERIORITY|The Fisher Test with asymptotic test statistic provided by the analysis software was used.|||||<|0.0001||||||This was the only a priori defined primary endpoint. There was no adjustment for multiple comparisons.|Fisher Exact|There was no adjustment for other variables intended for the primary analysis. Confounding variables were analysed in subsequent analyses.||Nullhypothesis was the equality of response rates of the treatment group and the control group. Treatments were compared by a two-sided Fisher test on a level of significance of 0.05. The study was appropriately powered (80%) for this analysis.||||<0.0001
91676730|NCT01524679|183248351|SUPERIORITY||Mean Difference (Final Values)|0.7525||||0.0957|TWO_SIDED|95.0|0.5382|1.0521|||ANCOVA|||||1.0521|0.5382|0.0957
91676731|NCT01524679|183248352|SUPERIORITY||Mean Difference (Final Values)|0.4621||||0.0005|TWO_SIDED|95.0|0.4621|0.7106|||ANCOVA|||||0.7106|0.4621|0.0005
91676732|NCT03801265|183248355|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||.770
91676733|NCT03801265|183248356|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||.826
91676734|NCT03801265|183248357|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||.859
91676735|NCT03801265|183248358|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||.904
91717216|NCT00264147|183327202|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|10.0||||||95.0|-0.66|20.46|||||CI based on the Wilson's score method.|||20.46|-0.66|
91717217|NCT00264147|183327202|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|9.18||||||95.0|-1.25|19.39|||||CI based on the Wilson's score method.|||19.39|-1.25|
91717218|NCT00264147|183327202|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|6.49||||||95.0|-3.76|16.61|||||CI based on the Wilson's score method.|||16.61|-3.76|
91717219|NCT00264147|183327203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.002
91717220|NCT00264147|183327203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.221
91486582|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.03|STANDARD_ERROR_OF_MEAN|2.06||0.6161|TWO_SIDED|95.0|-5.08|3.01|||ANCOVA|||Baseline sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.01|-5.08|0.6161
91676736|NCT03801265|183248359|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||.122
91676737|NCT03801265|183248360|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.379|||||||Wilcoxon (Mann-Whitney)|||||||.379
91676738|NCT03801265|183248361|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.881|||||||Wilcoxon (Mann-Whitney)|||||||.881
91717221|NCT00264147|183327203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.06||||||95.0|-6.44|-1.68||||||||-1.68|-6.44|
91717222|NCT00264147|183327203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||||95.0|-3.91|0.93||||||||0.93|-3.91|
91717223|NCT00264147|183327203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74||||||95.0|-5.13|-0.35||||||||-0.35|-5.13|
91717224|NCT00264147|183327203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||||95.0|-4.88|-0.12||||||||-0.12|-4.88|
91486583|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.63|STANDARD_ERROR_OF_MEAN|1.62||0.3154|TWO_SIDED|95.0|-4.83|1.56|||ANCOVA|||Week 16 sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.56|-4.83|0.3154
91486584|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.7|STANDARD_ERROR_OF_MEAN|3.18||0.593|TWO_SIDED|95.0|-7.94|4.54|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.54|-7.94|0.5930
91717225|NCT00264147|183327204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.001
91717226|NCT00264147|183327204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.125||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.125
91717227|NCT00264147|183327204|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.24||||||95.0|-3.64|-0.84||||||||-0.84|-3.64|
91486585|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|10.02|STANDARD_ERROR_OF_MEAN|2.42|<|0.0001|TWO_SIDED|95.0|5.27|14.76|||ANCOVA|||Week 16 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||14.76|5.27|<0.0001
91486586|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.54|STANDARD_ERROR_OF_MEAN|2.18||0.4807|TWO_SIDED|95.0|-5.83|2.75|||ANCOVA|||Baseline awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.75|-5.83|0.4807
91486587|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.88|STANDARD_ERROR_OF_MEAN|2.07||0.6708|TWO_SIDED|95.0|-3.18|4.94|||ANCOVA|||Week 16 awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.94|-3.18|0.6708
91486588|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7574|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Baseline quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.24|-0.32|0.7574
91486589|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.2615|TWO_SIDED|95.0|-0.1|0.38|||ANCOVA|||Week 16 quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.38|-0.10|0.2615
91527550|NCT04249336|182930404|SUPERIORITY||Mean Difference (Net)|33.0|||<|0.05|TWO_SIDED|95.0||||Threshold P\<0.05|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
91676739|NCT03801265|183248362|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.818|||||||Wilcoxon (Mann-Whitney)|||||||.818
91717228|NCT00264147|183327204|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02||||||95.0|-2.44|0.41||||||||0.41|-2.44|
91717229|NCT00264147|183327204|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22||||||95.0|-2.63|0.18||||||||0.18|-2.63|
91717230|NCT00264147|183327204|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||||95.0|-1.89|0.91||||||||0.91|-1.89|
91717231|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91486590|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.44|STANDARD_ERROR_OF_MEAN|2.53||0.5703|TWO_SIDED|95.0|-6.42|3.54|||ANCOVA|||Baseline adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.54|-6.42|0.5703
91526684|NCT03661996|182928695|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.9|STANDARD_ERROR_OF_MEAN|4.613|<|0.0001|TWO_SIDED|95.0|14.38|33.42|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||33.42|14.38|<0.0001
91526685|NCT03661996|182928695|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.62|STANDARD_ERROR_OF_MEAN|0.865|<|0.0001|TWO_SIDED|95.0|23.92|27.32|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.32|23.92|<0.0001
91526686|NCT03661996|182928695|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.053|<|0.0001|TWO_SIDED|95.0|20.03|24.17|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||24.17|20.03|<0.0001
91526687|NCT03661996|182928696|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|17.6|24.5|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||24.5|17.6|<0.0001
91526688|NCT03661996|182928696|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.3|STANDARD_ERROR_OF_MEAN|6.06||0.0003|TWO_SIDED|95.0|12.7|37.8|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||37.8|12.7|0.0003
91526689|NCT03661996|182928696|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.85|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|95.0|23.82|27.88|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||27.88|23.82|<0.0001
91526690|NCT03661996|182928696|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.34|STANDARD_ERROR_OF_MEAN|1.238|<|0.0001|TWO_SIDED|95.0|20.91|25.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||25.78|20.91|<0.0001
91526691|NCT03661996|182928697|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.86|STANDARD_ERROR_OF_MEAN|1.481|<|0.0001|TWO_SIDED|95.0|17.94|23.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.78|17.94|<0.0001
91527551|NCT04249336|182930404|SUPERIORITY||Mean Difference (Net)|23.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
91676740|NCT03801265|183248363|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.678|||||||Wilcoxon (Mann-Whitney)|||||||.678
91486591|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-2.99|STANDARD_ERROR_OF_MEAN|2.41||0.216|TWO_SIDED|95.0|-7.74|1.75|||ANCOVA|||Week 16 adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.75|-7.74|0.2160
91486592|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|1.07|STANDARD_ERROR_OF_MEAN|2.02||0.5952|TWO_SIDED|95.0|-2.89|5.03|||ANCOVA|||Baseline somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||5.03|-2.89|0.5952
91486593|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.72|STANDARD_ERROR_OF_MEAN|1.87||0.6984|TWO_SIDED|95.0|-4.4|2.95|||ANCOVA|||Week 16 somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.95|-4.40|0.6984
91676741|NCT03801265|183248364|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||.002
91486594|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.13|STANDARD_ERROR_OF_MEAN|1.64||0.9389|TWO_SIDED|95.0|-3.09|3.34|||ANCOVA|||Baseline sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.34|-3.09|0.9389
91486595|NCT00537238|182845798|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.64|STANDARD_ERROR_OF_MEAN|1.34||0.6344|TWO_SIDED|95.0|-2.0|3.27|||ANCOVA|||Week 16 sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.27|-2.00|0.6344
91486596|NCT00537238|182845799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.016||||0.9285|TWO_SIDED|95.0|0.715|1.444|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.444|0.715|0.9285
91486597|NCT00537238|182845799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.432||||0.0696|TWO_SIDED|95.0|0.972|2.11|||Regression, Logistic|||Week 16: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||2.110|0.972|0.0696
91486598|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Diphtheria Toxin \>=0.1 IU/mL||3.95|-3.99|<0.001
91486599|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Tetanus Toxin \>=0.01 IU/mL||3.95|-3.99|<0.001
91486600|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis Toxin \>=10 EU/mL||3.95|-3.99|<0.001
91486601|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis FHA \>=10 EU/mL||3.95|-3.99|<0.001
91486602|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 1 NA \>=8||3.95|-3.99|<0.001
91486603|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 2 NA \>=8||3.95|-3.99|<0.001
91486604|NCT01926015|182845810|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 3 NA \>=8||3.95|-3.99|<0.001
91676742|NCT03801265|183248365|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.007|||||||Chi-squared|||||||.007
91676743|NCT03801265|183248366|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||.271
91676744|NCT03801265|183248367|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||.810
91676745|NCT03801265|183248368|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||.676
91676746|NCT03801265|183248369|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.908|||||||Wilcoxon (Mann-Whitney)|||||||.908
91676747|NCT03801265|183248370|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||.270
91486605|NCT01364649|182845823|SUPERIORITY_OR_OTHER||LS mean difference|2.2|STANDARD_ERROR_OF_MEAN|0.9||0.013|TWO_SIDED|95.0|0.48|4.02|||Mixed Model Repeated Measurements|The primary analysis was performed by using observed case data only.||||4.02|0.48|0.013
91486606|NCT03615326|182845831|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.87|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.87|0.61|0.0002
91486607|NCT03615326|182845832|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.67|0.94|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|OS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.94|0.67|0.0040
91486608|NCT03615326|182845833|SUPERIORITY|The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Difference in Percentage|12.6||||0.0002|TWO_SIDED|95.0|5.6|19.4||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen Method|||ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||19.4|5.6|0.00020
91486609|NCT02651467|182845871|SUPERIORITY_OR_OTHER||Difference of Least Square mean|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.181|-0.584||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.||-0.584|-1.181|<0.0001
91486610|NCT02651467|182845871|SUPERIORITY_OR_OTHER||Diference of Least Square mean|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.333|-0.738||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the control, Dunnett's multiplicity adjustment is applied.||-0.738|-1.333|<0.0001
91486611|NCT02651467|182845872|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.15||||0.2478||95.0|-0.107|0.413||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.413|-0.107|0.2478
91486612|NCT02477839|182845876|OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.83|1.14|||ANCOVA|||Difference ratio in LS Mean was calculated as the exp \[LSMLCM-LSMplacebo\].||1.14|0.83|
91486613|NCT02477839|182845876|OTHER||Percent reduction|3.19|||=|0.6895|TWO_SIDED|95.0|-13.59|17.5|||ANCOVA|||Percent reduction over placebo was estimated as 100 x (1-exp \[LSMLCM-LSMPBO\]).||17.50|-13.59|=0.6895
91486614|NCT01439568|182845889|SUPERIORITY||Hazard Ratio (HR)|1.0608||||0.8072|TWO_SIDED|95.0|0.6598|1.7055|||Logrank Test|||||1.7055|0.6598|0.8072
91486615|NCT01050543|182845893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||<|0.0001|TWO_SIDED|95.0|6.8|9.6|||ANOVA|||To evaluate the efficacy of sugammadex compared to the efficacy of neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a 2-way ANOVA model adjusted for trial site.||9.6|6.8|<0.0001
91676748|NCT03801265|183248371|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
91676749|NCT03801265|183248372|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||.203
91486616|NCT01950169|182845896|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
91486617|NCT01950169|182845897|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
91486618|NCT01950169|182845898|SUPERIORITY|||||||0.05|||||||ANCOVA|The analyses included exposure measures treatment groups and sex as fixed factors. Age and baseline values for FFMI, FMI were included as covariates.||||||0.05
91676750|NCT03801265|183248373|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||.672
91676751|NCT04078126|183248374|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0179||0.345|TWO_SIDED|95.0|-0.054|0.02|||ANCOVA|||||0.020|-0.054|0.3450
91486619|NCT02905149|182845953|SUPERIORITY||Median Difference (Final Values)|9.0|||<|0.05|TWO_SIDED|95.0|4.0|14.5||Not adjusted for multiple comparison|Wilcoxon (Mann-Whitney)||Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.|||14.5|4|< 0.05
91486620|NCT02907268|182845959|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91486621|NCT02907268|182845960|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91486622|NCT02907268|182845961|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91486623|NCT02963935|182846044|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.|Treatment difference|-3.45||||0.0003|TWO_SIDED|95.0|-5.31|-1.59|||ANCOVA|Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.|Liraglutide 3.0 mg - placebo|Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide \< μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.||-1.59|-5.31|0.0003
91676752|NCT04078126|183248375|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0183||0.3675|TWO_SIDED|95.0|-0.054|0.021|||ANCOVA|||||0.021|-0.054|0.3675
91676753|NCT04078126|183248376|OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0199||0.7563|TWO_SIDED|95.0|-0.047|0.034|||ANCOVA|||||0.034|-0.047|0.7563
91486624|NCT02963935|182846044|OTHER|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)|Treatment difference|-4.59||||0|TWO_SIDED|95.0|-6.54|-2.64|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.||-2.64|-6.54|0.0000
91486625|NCT02963935|182846045|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0003|TWO_SIDED|95.0|1.53|4.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.14|1.53|0.0003
91486626|NCT02963935|182846045|OTHER||Odds Ratio (OR)|2.84||||0|TWO_SIDED|95.0|1.75|4.61|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||4.61|1.75|0.0000
91676754|NCT04078126|183248377|OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.0521||0.5419|TWO_SIDED|95.0|-0.139|0.075|||ANCOVA|||||0.075|-0.139|0.5419
91676755|NCT04078126|183248378|OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|2.334||0.1337|TWO_SIDED|95.0|-8.39|1.18|||ANCOVA|||||1.18|-8.39|0.1337
91676756|NCT04078126|183248379|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.269||0.0431|TWO_SIDED|95.0|-5.29|-0.09|||ANCOVA|||||-0.09|-5.29|0.0431
91676757|NCT04078126|183248380|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.667||0.3625|TWO_SIDED|95.0|-4.87|1.81|||ANCOVA|||||1.81|-4.87|0.3625
91676758|NCT04078126|183248381|OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.0198||0.0375|TWO_SIDED|95.0|0.003|0.084|||ANCOVA|||||0.084|0.003|0.0375
91676759|NCT04078126|183248382|OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.0443||0.9089|TWO_SIDED|95.0|-0.086|0.096|||ANCOVA|||||0.096|-0.086|0.9089
91676760|NCT03056157|183248383|SUPERIORITY||Slope|-0.236||||0.03|TWO_SIDED|95.0|-3.34|-0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1519 )= -2.19, d = 0.15.||-0.18|-3.34|0.03
91676761|NCT03056157|183248383|SUPERIORITY||Slope|-8.97|||<|0.001|TWO_SIDED|95.0|-10.12|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to- treat data for SDS scores, t(160)= -15.74, d = 2.97.||-6.11|-10.12|<.001
91676762|NCT03056157|183248383|SUPERIORITY||Slope|-6.62|||<|0.001|TWO_SIDED|95.0|-8.35|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(160) = -12.72, d = 1.86.||-6.11|-8.35|<0.001
91676763|NCT03056157|183248383|SUPERIORITY||Slope|-0.65||||0.49|TWO_SIDED|95.0|-2.13|0.86|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = -0.90, d = 0.05.||0.86|-2.13|0.49
91676764|NCT03056157|183248383|SUPERIORITY||Slope|1.1|||<|0.001|TWO_SIDED|95.0|0.06|2.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 2.11, d = 0.11.||2.17|0.06|<0.001
91676765|NCT03056157|183248383|SUPERIORITY||Slope|1.75|||<|0.001|TWO_SIDED|95.0|0.75|2.81|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 3.45, d = 0.18||2.81|0.75|<0.001
91676766|NCT03056157|183248384|SUPERIORITY||Odds Ratio (OR)|2.35||||0.03|TWO_SIDED|95.0|1.01|5.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.56|1.01|0.03
91676767|NCT03056157|183248384|SUPERIORITY||Odds Ratio (OR)|0.0||||0.01|TWO_SIDED|95.0|0.0|0.71|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced improvement from baseline to post-treatment in SDS in AD-MIL versus PCT.||0.71|0|0.01
91676768|NCT03056157|183248384|SUPERIORITY||Odds Ratio (OR)|0.82||||0.69|TWO_SIDED|95.0|0.35|1.87|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced no change in SDS from baseline to post-treatment in AD-MIL versus PCT.||1.87|0.35|.69
91676769|NCT03056157|183248384|SUPERIORITY||Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|0.0|0.0|5.83|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced deterioration in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.83|0|0.50
91486627|NCT02963935|182846046|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0469|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.||3.14|1.01|0.0469
91486628|NCT02963935|182846046|OTHER||Odds Ratio (OR)|2.14||||0.0063|TWO_SIDED|95.0|1.24|3.69|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||3.69|1.24|0.0063
91526692|NCT03661996|182928697|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.66|STANDARD_ERROR_OF_MEAN|4.568|<|0.0001|TWO_SIDED|95.0|16.24|35.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||35.09|16.24|<0.0001
91486629|NCT02963935|182846047|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0311|TWO_SIDED|95.0|1.08|4.74|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.74|1.08|0.0311
91486630|NCT02963935|182846047|OTHER||Odds Ratio (OR)|2.74||||0.006|TWO_SIDED|95.0|1.33|5.62|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||5.62|1.33|0.0060
91676770|NCT03056157|183248385|SUPERIORITY||Slope|-3.39||||0.35|TWO_SIDED|95.0|-10.57|3.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.93, d = 0.10.||3.79|-10.57|0.35
91676771|NCT03056157|183248385|SUPERIORITY||Slope|-8.64||||0.001|TWO_SIDED|95.0|-13.83|-3.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for BIPF scores, t(116) = -3.27, d = 0.61.||-3.44|-13.83|0.001
91676772|NCT03056157|183248385|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
91676773|NCT03056157|183248385|SUPERIORITY||Slope|-5.17||||0.08|TWO_SIDED|95.0|-10.86|0.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -1.79, d = 0.20.||0.52|-10.86|0.08
91676774|NCT03056157|183248385|SUPERIORITY||Slope|-5.64||||0.007|TWO_SIDED|95.0|-9.72|-1.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -2.72, d = 0.30.||-1.57|-9.72|0.007
91676775|NCT03056157|183248385|SUPERIORITY||Slope|-0.47||||0.82|TWO_SIDED|95.0|-4.44|3.5|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.23, d = 0.03.||3.50|-4.44|0.82
91676776|NCT03056157|183248386|SUPERIORITY||Slope|-0.6||||0.75|TWO_SIDED|95.0|-4.68|3.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.32, d = 0.03.||3.36|-4.68|0.75
91676777|NCT03056157|183248386|SUPERIORITY||Slope|-9.12|||<|0.001|TWO_SIDED|95.0|-12.12|-6.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.01, d = 1.97.||-6.12|-12.12|<0.001
91676778|NCT03056157|183248386|SUPERIORITY||Slope|-8.72|||<|0.001|TWO_SIDED|95.0|-11.16|-5.76|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.11, d = 2.01.||-5.76|-11.16|<0.001
91676779|NCT03056157|183248386|SUPERIORITY||Slope|-2.28||||0.56|TWO_SIDED|95.0|-10.08|5.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.59, d = 0.06.||5.52|-10.08|0.56
91676780|NCT03056157|183248386|SUPERIORITY||Slope|4.2||||0.22|TWO_SIDED|95.0|-0.24|10.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 1.25, d = 0.13.||10.92|-0.24|0.22
91676781|NCT03056157|183248386|SUPERIORITY||Slope|6.6||||0.002|TWO_SIDED|95.0|2.52|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 3.18, d = 0.33.||10.69|2.52|0.002
91676782|NCT03056157|183248387|SUPERIORITY||Slope|0.48||||0.92|TWO_SIDED|95.0|-9.6|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = 0.10, d = 0.01.||10.69|-9.60|0.92
91676783|NCT03056157|183248387|SUPERIORITY||Slope|-16.08|||<|0.001|TWO_SIDED|95.0|-23.64|-8.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.23, d = 1.39.||-8.52|-23.64|<0.001
91676784|NCT03056157|183248387|SUPERIORITY||Slope|-16.56|||<|0.001|TWO_SIDED|95.0|-23.4|-9.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.77, d = 1.57.||-9.72|-23.40|<0.001
91676785|NCT03056157|183248387|SUPERIORITY||Slope|-26.28||||0.002|TWO_SIDED|95.0|-42.6|-9.84|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = -3.15, d = 0.33.||-9.84|-42.60|0.002
91676786|NCT03056157|183248387|SUPERIORITY||Slope|-18.72||||0.01|TWO_SIDED|95.0|-32.4|-4.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -2.67, d = 0.28.||-4.92|-32.40|0.01
91676787|NCT03056157|183248387|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B- IPF scores, the Pre-Post PCT Time slope was -5.25 \[95% CI = -10.21, -0.29\], p-value = 0.04, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
91692350|NCT01436370|183279660|SUPERIORITY_OR_OTHER|||||||0.087|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.087
91676788|NCT03056157|183248388|SUPERIORITY||Slope|-6.38||||0.1|TWO_SIDED|95.0|-13.97|1.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = -1.69, d = 0.48.||1.22|-13.97|0.10
91676789|NCT03056157|183248388|SUPERIORITY||Slope|-13.29|||<|0.001|TWO_SIDED|95.0|-18.96|-7.62|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -4.71, d = 1.67.||-7.62|-18.96|<0.001
91676790|NCT03056157|183248388|SUPERIORITY||Slope|-6.92||||0.001|TWO_SIDED|95.0|-11.96|-1.87|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -2.75, d = 0.97.||-1.87|-11.96|0.001
91676791|NCT03056157|183248388|SUPERIORITY||Slope|5.22||||0.34|TWO_SIDED|95.0|-5.6|16.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.97, d = 0.28.||16.05|-5.60|0.34
91676792|NCT03056157|183248388|SUPERIORITY||Slope|5.93||||0.17|TWO_SIDED|95.0|-2.55|14.41|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 1.40, d = 0.40.||14.41|-2.55|0.17
91676793|NCT03056157|183248388|SUPERIORITY||Slope|0.7||||0.83|TWO_SIDED|95.0|-6.04|7.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.21, d = 0.06.||7.44|-6.04|0.83
91676794|NCT03056157|183248389|SUPERIORITY||Slope|0.6||||0.76|TWO_SIDED|95.0|-3.12|4.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 0.30, d = 0.03.||4.20|-3.12|0.76
91676795|NCT03056157|183248389|SUPERIORITY||Slope|-3.12||||0.002|TWO_SIDED|95.0|-6.96|-1.56|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.14, d = 1.03.||-1.56|-6.96|0.002
91676796|NCT03056157|183248389|SUPERIORITY||Slope|-4.92|||<|0.001|TWO_SIDED|95.0|-7.32|-2.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.88, d = 1.27.||-2.40|-7.32|<0.001
91676797|NCT03056157|183248389|SUPERIORITY||Slope|-4.8||||0.13|TWO_SIDED|95.0|-11.16|1.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -1.50, d = 0.16.||1.44|-11.16|0.13
91676798|NCT03056157|183248389|SUPERIORITY||Slope|-2.4||||0.38|TWO_SIDED|95.0|-7.68|3.0|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -0.87, d = 0.09.||3.00|-7.68|0.38
91676799|NCT03056157|183248389|SUPERIORITY||Slope|2.4||||0.26|TWO_SIDED|95.0|-0.96|5.88|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 1.42, d = 0.15.||5.88|-0.96|0.26
91676800|NCT03056157|183248390|SUPERIORITY||Slope|-6.65|||<|0.001|TWO_SIDED|95.0|-10.23|-3.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -3.65, d = 0.39.||-3.07|-10.23|<0.001
91676801|NCT03056157|183248390|SUPERIORITY||Slope|-11.88|||<|0.001|TWO_SIDED|95.0|-14.43|-9.32|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -9.14, d = 1.60.||-9.32|-14.43|<0.001
91676802|NCT03056157|183248390|SUPERIORITY||Slope|-5.23|||<|0.001|TWO_SIDED|95.0|-7.74|-2.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -4.10, d = 0.72.||-2.72|-7.74|<0.001
91676803|NCT03056157|183248390|SUPERIORITY||Slope|1.36||||0.39|TWO_SIDED|95.0|-1.73|4.45|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.87, d = 0.09.||4.45|-1.73|0.39
91676804|NCT03056157|183248390|SUPERIORITY||Slope|0.08||||0.94|TWO_SIDED|95.0|-2.1|2.26|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.07, d = 0.001.||2.26|-2.10|0.94
91676805|NCT03056157|183248390|SUPERIORITY||Slope|-1.28||||0.25|TWO_SIDED|95.0|-3.48|0.91|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -1.15, d = 0.12.||0.91|-3.48|0.25
91676806|NCT03056157|183248391|SUPERIORITY||Odds Ratio (OR)|6.44||||0.01|TWO_SIDED|95.0|1.29|63.18|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||63.18|1.29|0.01
91676807|NCT03056157|183248391|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4|TWO_SIDED|95.0|0.61|3.75|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced improvement in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||3.75|0.61|0.40
91717232|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91717233|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91676808|NCT03056157|183248391|SUPERIORITY||Odds Ratio (OR)|0.78||||0.58|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced no change in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.70|0.36|0.58
91676809|NCT03056157|183248391|SUPERIORITY||Odds Ratio (OR)|0.15||||0.06|TWO_SIDED|95.0|0.003|1.2|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced deterioration in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.20|0.003|0.06
91676810|NCT03056157|183248392|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.22|1.06|||Fisher Exact|||Odds ratio comparison of the proportions of participants with a PTSD Diagnosis in CAPS-5 at post-treatment in AD-MIL versus PCT.||1.06|0.22|0.07
91676811|NCT03056157|183248392|SUPERIORITY||Odds Ratio (OR)|0.66||||0.33|TWO_SIDED|95.0|0.28|1.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 3MFU in AD-MIL versus PCT.||1.56|0.28|0.33
91676812|NCT03056157|183248392|SUPERIORITY||Odds Ratio (OR)|0.42||||0.05|TWO_SIDED|95.0|0.15|1.08|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 6MFU in AD-MIL versus PCT.||1.08|0.15|0.05
91676813|NCT03056157|183248393|SUPERIORITY||Slope|-4.63||||0.003|TWO_SIDED|95.0|-7.16|-2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -3.01, d = 0.13.||-2.10|-7.16|.003
91486631|NCT02963935|182846048|SUPERIORITY||Odds Ratio (OR)|3.32|||<|0.0001|TWO_SIDED|95.0|1.93|5.72|||Regression, Logistic||Liraglutide 3.0 mg/placebo|"Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.~Missing values are considered as non-responders."||5.72|1.93|<0.0001
91717234|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.023
91486632|NCT02963935|182846049|SUPERIORITY||treatment difference|-2.72||||0.0063|TWO_SIDED|95.0|-4.68|-0.77|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||-0.77|-4.68|0.0063
91486633|NCT02963935|182846049|OTHER||Treatment difference|-3.45||||0.002|TWO_SIDED|95.0|-5.62|-1.28|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||-1.28|-5.62|0.0020
91486634|NCT02963935|182846050|SUPERIORITY||Treatment difference|0.16||||0.8137|TWO_SIDED|95.0|-1.19|1.52|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||1.52|-1.19|0.8137
91486635|NCT02963935|182846050|OTHER||Treatment difference|0.16||||0.8053|TWO_SIDED|95.0|-1.12|1.43|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg- placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||1.43|-1.12|0.8053
91486636|NCT02963935|182846051|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|0.87||||0.6916|TWO_SIDED|95.0|-3.41|5.14|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||5.14|-3.41|0.6916
91486637|NCT02963935|182846051|OTHER||treatment difference|1.25||||0.5572|TWO_SIDED|95.0|-2.95|5.45|||Mixed models repeated measurements (MMRM||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||5.45|-2.95|0.5572
91486638|NCT02963935|182846052|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|3.12||||0.6986|TWO_SIDED|95.0|-12.68|18.92|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||18.92|-12.68|0.6986
91486639|NCT02963935|182846052|OTHER||Treatment difference|7.66||||0.37|TWO_SIDED|95.0|-9.15|24.48|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||24.48|-9.15|0.3700
91676814|NCT03056157|183248393|SUPERIORITY||Slope|-12.62|||<|0.001|TWO_SIDED|95.0|-14.43|-10.8|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -11.50, d = 1.81.||-10.80|-14.43|<0.001
91676815|NCT03056157|183248393|SUPERIORITY||Slope|-7.89|||<|0.001|TWO_SIDED|95.0|-9.77|-6.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -7.40, d = 1.16.||-6.20|-9.77|<0.001
91676816|NCT03056157|183248393|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-4.01|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -0.45, d = 0.02.||2.52|-4.01|0.65
91676817|NCT03056157|183248393|SUPERIORITY||Slope|2.3||||0.05|TWO_SIDED|95.0|-0.03|4.63|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 1.94, d = 0.10.||4.63|-0.03|0.05
91676818|NCT03056157|183248393|SUPERIORITY||Slope|3.04||||0.001|TWO_SIDED|95.0|0.75|5.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 2.61, d = 0.13.||5.34|0.75|0.001
91676819|NCT03056157|183248394|SUPERIORITY||Odds Ratio (OR)|2.39||||0.04|TWO_SIDED|95.0|1.01|5.84|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing probable recovery in PCL-5 at post-treatment in AD-MIL versus PCT.||5.84|1.01|0.04
91676820|NCT03056157|183248394|SUPERIORITY||Odds Ratio (OR)|0.7||||0.49|TWO_SIDED|95.0|0.25|1.95|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing improvement in PCL-5 at post-treatment in AD-MIL versus PCT.||1.95|0.25|0.49
91676821|NCT03056157|183248394|SUPERIORITY||Odds Ratio (OR)|0.58||||0.18|TWO_SIDED|95.0|0.25|1.32|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing no change in PCL-5 at post-treatment in AD-MIL versus PCT.||1.32|0.25|0.18
91526693|NCT03661996|182928697|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.57|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|23.88|27.26|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.26|23.88|<0.0001
91526694|NCT03661996|182928697|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.69|STANDARD_ERROR_OF_MEAN|0.853|<|0.0001|TWO_SIDED|95.0|24.02|27.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.37|24.02|<0.0001
91526695|NCT03661996|182928698|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.17|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|95.0|20.74|29.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.60|20.74|<0.0001
91526696|NCT03661996|182928698|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|33.11|STANDARD_ERROR_OF_MEAN|5.795|<|0.0001|TWO_SIDED|95.0|21.15|45.07|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||45.07|21.15|<0.0001
91526697|NCT03661996|182928698|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|27.8|STANDARD_ERROR_OF_MEAN|1.233|<|0.0001|TWO_SIDED|95.0|25.38|30.23|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||30.23|25.38|<0.0001
91526698|NCT03661996|182928698|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|24.8|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|21.66|27.94|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.94|21.66|<0.0001
91526699|NCT03661996|182928699|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.898|<|0.0001|TWO_SIDED|95.0|18.37|25.84|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.84|18.37|<0.0001
91526700|NCT03661996|182928699|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|16.75|STANDARD_ERROR_OF_MEAN|6.255|<|0.0001|TWO_SIDED|95.0|3.84|29.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.66|3.84|<0.0001
91526701|NCT03661996|182928699|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.52|STANDARD_ERROR_OF_MEAN|1.062|<|0.0001|TWO_SIDED|95.0|19.43|23.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.60|19.43|<0.0001
91526702|NCT03661996|182928699|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|19.4|STANDARD_ERROR_OF_MEAN|1.365|<|0.0001|TWO_SIDED|95.0|16.72|22.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||22.09|16.72|<0.0001
91676822|NCT03056157|183248395|SUPERIORITY||Slope|-0.99||||0.14|TWO_SIDED|95.0|-2.29|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = -1.46, d = 0.07||0.34|-2.29|0.14
91676823|NCT03056157|183248395|SUPERIORITY||Slope|-5.87|||<|0.001|TWO_SIDED|95.0|-6.8|-4.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -12.41, d = 1.96.||-4.90|-6.80|<0.001
91676824|NCT03056157|183248395|SUPERIORITY||Slope|-4.89|||<|0.001|TWO_SIDED|95.0|-5.82|-3.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -10.29, d = 1.62.||-3.94|-5.82|<0.001
91676825|NCT03056157|183248395|SUPERIORITY||Slope|0.02||||0.68|TWO_SIDED|95.0|-0.99|1.53|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 0.42, d = 0.02.||1.53|-0.99|0.68
91486640|NCT03911154|182846095|OTHER|We used linear mixed effect models (in SAS version 9.4, SAS Institute, Cary, NC) with random subject intercept to account for the clustered nature of the data. The model included factors for stimulus modality (4 levels), sleep restriction night (4 levels), and their interaction.|Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.353||0.36|TWO_SIDED|95.0|-0.403|1.06|||Mixed Models Analysis|||Number of lapses of attention were averaged across assessments within each day and the statistical analysis adjusted for baseline.||1.060|-0.403|0.36
91486641|NCT03911154|182846095|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.307|STANDARD_ERROR_OF_MEAN|0.441||0.49|TWO_SIDED|95.0|-1.222|0.608|||Mixed Models Analysis|||Number of lapses of attention upon emergent awakening||0.608|-1.222|0.49
91486642|NCT03911154|182846096|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.455|STANDARD_ERROR_OF_MEAN|2.797||0.87|TWO_SIDED|95.0|-5.4|6.31|||Mixed Models Analysis|||||6.310|-5.400|0.87
91486643|NCT03911154|182846097|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.112|STANDARD_ERROR_OF_MEAN|0.798||0.89|TWO_SIDED|95.0|-1.767|1.543|||Mixed Models Analysis|||Number correct on the DSST was averaged across DSST administrations within each day and was adjusted for baseline performance.||1.543|-1.767|0.89
91486644|NCT03911154|182846098|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.381||0.76|TWO_SIDED|95.0|-0.919|0.678|||Mixed Models Analysis|||Number correct on the DST was averaged across DST administrations within each day and adjusted for baseline.||0.678|-0.919|0.76
91486645|NCT03911154|182846099|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.179||0.64|TWO_SIDED|95.0|-0.286|0.456|||Mixed Models Analysis|||The mean weighted score on the ROBoT was adjusted for baseline.||0.456|-0.286|0.64
91486646|NCT00543543|182846121|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.7|||<|0.0001|TWO_SIDED|95.0|80.9|99.8|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.8|80.9|<0.0001
91486647|NCT00543543|182846122|SUPERIORITY_OR_OTHER||Vaccine efficacy|97.4|||||TWO_SIDED|95.0|85.0|99.9|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.9|85.0|
91486648|NCT00543543|182846123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.99|1.06|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 6||1.06|0.99|<0.001
91486649|NCT00543543|182846123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.77|0.83|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 11||0.83|0.77|<0.001
91486650|NCT00543543|182846123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.96|1.03|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 16||1.03|0.96|<0.001
91486651|NCT00543543|182846123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.14|1.23|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 18||1.23|1.14|<0.001
91486652|NCT00543543|182846130|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.0|||||TWO_SIDED|95.0|94.6|97.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||97.1|94.6|
91486653|NCT04502979|182846142|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.21||0.07|TWO_SIDED|95.0|-0.11|0.73||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||0.73|-0.11|0.07
91486654|NCT04502979|182846143|SUPERIORITY||Mean Difference (Net)|-121.16|STANDARD_ERROR_OF_MEAN|65.73||0.04|TWO_SIDED|95.0|-252.73|10.41||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||10.41|-252.73|0.04
91486655|NCT01881373|182846144|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-3.88||||0.02|TWO_SIDED|95.0|-7.29|-0.47|||Regression, Logistic|Hierarchical model.|Intervention vs control communities comparing 24 months to baseline|||-0.47|-7.29|0.02
91486656|NCT01881373|182846144|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-2.63||||0.28|TWO_SIDED|95.0|-8.58|3.32||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.32|-8.58|0.28
91486657|NCT01881373|182846145|SUPERIORITY|Hierarchical model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.64||||0.009|TWO_SIDED|95.0|-2.87|-0.41||Intervention vs control communities comparing 78 months to baseline.|Regression, Linear|Hierarchical model.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.41|-2.87|0.009
91676826|NCT03056157|183248395|SUPERIORITY||Slope|1.36||||0.003|TWO_SIDED|95.0|0.48|2.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 3.02, d = 0.15.||2.24|0.48|0.003
91692351|NCT01436370|183279661|SUPERIORITY_OR_OTHER|||||||0.234|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 7.||||0.234
91676827|NCT03056157|183248395|SUPERIORITY||Slope|1.09||||0.02|TWO_SIDED|95.0|0.19|1.99|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 2.37, d = 0.12.||1.99|0.19|0.02
91526703|NCT03661996|182928700|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.48|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-3.86|-3.1|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.10|-3.86|<0.0001
91526704|NCT03661996|182928700|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.52|STANDARD_ERROR_OF_MEAN|0.416|<|0.0001|TWO_SIDED|95.0|-4.38|-2.67|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-2.67|-4.38|<0.0001
91526705|NCT03661996|182928700|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-4.02|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-4.25|-3.79|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.79|-4.25|<0.0001
91526706|NCT03661996|182928700|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-3.96|-3.48|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.48|-3.96|<0.0001
91526707|NCT01161472|182928715|SUPERIORITY_OR_OTHER||Least square (LS) Mean Difference|-0.0285|STANDARD_ERROR_OF_MEAN|0.018||0.1198|TWO_SIDED|95.0|-0.0647|0.0077|||ANCOVA|||Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0077|-0.0647|0.1198
91526708|NCT01161472|182928715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0203|STANDARD_ERROR_OF_MEAN|0.0173||0.2459|TWO_SIDED|95.0|-0.0551|0.0145|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0145|-0.0551|0.2459
91526709|NCT01161472|182928717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0037|STANDARD_ERROR_OF_MEAN|0.0115||0.7502|TWO_SIDED|95.0|-0.0268|0.0194|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0194|-0.0268|0.7502
91526710|NCT01161472|182928717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0085|STANDARD_ERROR_OF_MEAN|0.0119||0.4785|TWO_SIDED|95.0|-0.0325|0.0154|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0154|-0.0325|0.4785
91526711|NCT01161472|182928719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0035|STANDARD_ERROR_OF_MEAN|0.0265||0.8944|TWO_SIDED|95.0|-0.0569|0.0498|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0498|-0.0569|0.8944
91526712|NCT01161472|182928719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0209|STANDARD_ERROR_OF_MEAN|0.0263||0.4308|TWO_SIDED|95.0|-0.032|0.0738|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0738|-0.0320|0.4308
91526713|NCT01161472|182928721|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6629|STANDARD_ERROR_OF_MEAN|12.4945||0.7707|TWO_SIDED|95.0|-21.4729|28.7987|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||28.7987|-21.4729|0.7707
91676828|NCT03056157|183248396|SUPERIORITY||Slope|-0.2||||0.18|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = -1.35, d = 0.15.||0.09|-0.49|0.18
91676829|NCT03056157|183248396|SUPERIORITY||Slope|-0.26||||0.02|TWO_SIDED|95.0|-0.47|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -2.44, d = 0.46.||-0.05|-0.47|0.02
91676830|NCT03056157|183248396|SUPERIORITY||Slope|-0.06||||0.62|TWO_SIDED|95.0|-0.26|0.14|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.69, d = 0.12.||0.14|-0.26|0.62
91676831|NCT03056157|183248396|SUPERIORITY||Slope|0.16||||0.18|TWO_SIDED|95.0|-0.07|0.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = 1.34, d = 0.15.||0.39|-0.07|0.18
91676832|NCT03056157|183248396|SUPERIORITY||Slope|0.13||||0.14|TWO_SIDED|95.0|-0.04|0.3|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = 1.49, d = 0.28.||0.30|-0.04|0.14
91676833|NCT03056157|183248396|SUPERIORITY||Slope|-0.03||||0.71|TWO_SIDED|95.0|-0.19|0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.38, d = 0.07.||0.13|-0.19|0.71
91717235|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.16||||||95.0|-19.38|-8.95||||||||-8.95|-19.38|
91526714|NCT01161472|182928721|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.921|STANDARD_ERROR_OF_MEAN|12.4482||0.1162|TWO_SIDED|95.0|-44.9634|5.1215|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||5.1215|-44.9634|0.1162
91526715|NCT01161472|182928723|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0068|STANDARD_ERROR_OF_MEAN|4.8707||0.9989|TWO_SIDED|95.0|-9.8297|9.8433|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||9.8433|-9.8297|0.9989
91526716|NCT01161472|182928723|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6251|STANDARD_ERROR_OF_MEAN|5.0346||0.7485|TWO_SIDED|95.0|-11.7926|8.5425|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||8.5425|-11.7926|0.7485
91526717|NCT01161472|182928725|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2684|STANDARD_ERROR_OF_MEAN|0.8243||0.7458|TWO_SIDED|95.0|-1.3788|1.9157|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.9157|-1.3788|0.7458
91526718|NCT01161472|182928725|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0661|STANDARD_ERROR_OF_MEAN|0.8277||0.9366|TWO_SIDED|95.0|-1.7202|1.588|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.5880|-1.7202|0.9366
91526719|NCT00791921|182928741|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||For ACR20 responder rate at Week 12, comparison between the CDP870 200 mg group and the placebo group was performed.||||<0.05
91526720|NCT00791921|182928742|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||||||<0.05
91526721|NCT01965158|182928743|SUPERIORITY_OR_OTHER||Difference|13.0|STANDARD_ERROR_OF_MEAN|4.19||0.002|TWO_SIDED|95.0|4.8|21.3||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||21.3|4.8|0.0020
91526722|NCT01965158|182928744|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.77|1.83|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.83|0.77|<0.0001
91526723|NCT01965158|182928745|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.6|2.63|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.63|1.60|<0.0001
91526724|NCT01965158|182928746|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.54|1.48|||ANCOVA|ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.48|0.54|<0.0001
91526725|NCT01965158|182928747|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.198||0.0003|TWO_SIDED|95.0|0.34|1.12|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.12|0.34|0.0003
91526726|NCT02912468|182928748|SUPERIORITY||LS mean difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.71|||ANCOVA|||Data were analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.07|<0.0001
91526727|NCT02912468|182928749|SUPERIORITY||LS mean difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.69|||ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.69|-2.43|<0.0001
91676834|NCT03056157|183248397|SUPERIORITY||Slope|-0.47|||<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = -3.41, d = 0.39.||-0.20|-0.74|<0.001
91676835|NCT03056157|183248397|SUPERIORITY||Slope|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -6.41, d = 1.20.||-0.44|-0.83|<0.001
91676836|NCT03056157|183248397|SUPERIORITY||Slope|-0.17||||0.07|TWO_SIDED|95.0|-0.36|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -1.83, d = 0.34.||0.02|-0.36|0.07
91676837|NCT03056157|183248397|SUPERIORITY||Slope|0.35||||0.002|TWO_SIDED|95.0|0.13|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = 3.13, d = 0.06.||0.57|0.13|0.002
91526728|NCT02912468|182928750|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 24 SNOT-22.|LS mean difference|-7.44|||<|0.0001|TWO_SIDED|95.0|-8.35|-6.53||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-6.53|-8.35|<.0001
91527552|NCT04249336|182930405|SUPERIORITY||Mean Difference (Net)|32.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
91717236|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.21||||||95.0|-14.52|-3.9||||||||-3.90|-14.52|
91717237|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.87||||||95.0|-14.11|-3.63||||||||-3.63|-14.11|
91717238|NCT00264147|183327205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.05||||||95.0|-11.27|-0.83||||||||-0.83|-11.27|
91717239|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91717240|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91717241|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91717242|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
91717243|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||||95.0|-0.77|-0.35||||||||-0.35|-0.77|
91717244|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.13||||||||-0.13|-0.55|
91717245|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-0.61|-0.19||||||||-0.19|-0.61|
91717246|NCT00264147|183327206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25||||||95.0|-0.46|-0.04||||||||-0.04|-0.46|
91717247|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
91717248|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
91717249|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.017
91717250|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.080
91717251|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44||||||95.0|-19.62|-9.26||||||||-9.26|-19.62|
91717252|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.22||||||95.0|-11.52|-0.92||||||||-0.92|-11.52|
91717253|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.32||||||95.0|-11.53|-1.12||||||||-1.12|-11.53|
91717254|NCT00264147|183327207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.63||||||95.0|-9.81|0.55||||||||0.55|-9.81|
91717255|NCT02563899|183327238|SUPERIORITY_OR_OTHER||Percent difference in treatment|-1.0|||||TWO_SIDED|95.0|-42.2|39.9||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-30%||39.9|-42.2|
91717256|NCT02563899|183327238|SUPERIORITY_OR_OTHER||Percent difference in treatment|1.0|||||TWO_SIDED|95.0|-39.9|42.2||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD vs Vehicle: \<=-50%||42.2|-39.9|
91717257|NCT02563899|183327238|SUPERIORITY_OR_OTHER||Percent difference in treatment|9.0|||||TWO_SIDED|95.0|-25.2|44.0||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-70%||44.0|-25.2|
91717258|NCT02563899|183327240|SUPERIORITY_OR_OTHER||Percent difference in treatment|27.0|||||TWO_SIDED|95.0|-8.5|62.6||||||||62.6|-8.5|
91717259|NCT00369343|183327258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.32|||<|0.001||95.0|2.53|6.11|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.|DVS SR adjusted mean change minus placebo adjusted mean change.|||6.11|2.53|<0.001
91717260|NCT00369343|183327259|SUPERIORITY_OR_OTHER||||||<|0.001||||||DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).|Cochran-Mantel-Haenszel|||||||<0.001
91717261|NCT00369343|183327260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.132||||0.008||95.0|1.22|3.74||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.|||3.74|1.22|0.008
91717262|NCT00369343|183327261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125|||<|0.001||95.0|1.85|5.27||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.|||5.27|1.85|<0.001
91717263|NCT00369343|183327262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.74|||<|0.001||95.0|1.24|4.23||Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||4.23|1.24|<0.001
91717264|NCT00369343|183327263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.18|-0.06||Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||-0.06|-0.18|<0.001
91717265|NCT00369343|183327270|SUPERIORITY_OR_OTHER|||||||0.553||||||t-test adjusted by multiple comparison|t-test, 2 sided|||100mg vs. Placebo (0mg) post taper||||0.553
91717266|NCT00369343|183327270|SUPERIORITY_OR_OTHER|||||||0.034||||||t-test adjusted by multiple comparison|t-test, 2 sided|||200mg vs. Placebo (0mg) post taper||||0.034
91486658|NCT01881373|182846145|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|4.35||||0.49|TWO_SIDED|95.0|-8.5|17.24|||Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal comparing 78 months to baseline.||17.24|-8.5|0.49
91486659|NCT01881373|182846146|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-3.6|||<|0.01|TWO_SIDED||||||Regression, Logistic|Hierarchical model||Intervention vs control comparing 24 months to baseline.||||<0.01
91486660|NCT01881373|182846147|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|change in prevalence between communities|-12.6||||0.003|TWO_SIDED|95.0|-20.92|-4.28||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-4.28|-20.92|0.003
91486661|NCT01881373|182846147|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-3.43||||0.33|TWO_SIDED|95.0|-10.36|3.5||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Temporal communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.50|-10.36|0.33
91486662|NCT01881373|182846148|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.71||||0.02|TWO_SIDED|95.0|-1.37|-0.05||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.05|-1.37|0.02
91486663|NCT01881373|182846148|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.65||||0.13|TWO_SIDED|95.0|-1.79|0.49||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||0.49|-1.79|0.13
91676838|NCT03056157|183248397|SUPERIORITY||Slope|0.18||||0.03|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = 2.21, d = 0.42.||0.34|0.02|0.03
91486664|NCT01881373|182846149|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.01||||0.86|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.86
91486665|NCT01881373|182846150|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.17||||0.68|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.68
91486666|NCT01881373|182846151|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|3.42||||0.55|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.55
91486667|NCT01881373|182846152|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.5||||0.11|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.11
91486668|NCT01881373|182846153|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.7||||0.08|TWO_SIDED||||||Regression, Linear|||mixed model adjusting for age and sex and cluster of community and strata of jurisdiction; intervention vs control comparing 24 months to baseline||||0.08
91676839|NCT03056157|183248397|SUPERIORITY||Slope|-0.17||||0.03|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -2.22, d = 0.42.||-0.02|-0.32|0.03
91676840|NCT03056157|183248398|SUPERIORITY||Slope|0.32||||0.01|TWO_SIDED|95.0|0.06|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = 2.46, d = 0.28.||0.57|0.06|0.01
91486669|NCT01881373|182846154|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.04||||0.71|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.71
91486670|NCT01881373|182846155|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.02||||0.54|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.54
91676841|NCT03056157|183248398|SUPERIORITY||Slope|0.001||||0.95|TWO_SIDED|95.0|-0.17|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.06, d = 0.01.||0.18|-0.17|0.95
91676842|NCT03056157|183248398|SUPERIORITY||Slope|-0.31||||0.01|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = -3.32, d = 0.62.||-0.13|-0.50|0.01
91676843|NCT03056157|183248398|SUPERIORITY||Slope|-0.21||||0.04|TWO_SIDED|95.0|-0.41|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = -2.02, d = 0.23.||-0.01|-0.41|0.04
91676844|NCT03056157|183248398|SUPERIORITY||Slope|-0.16||||0.03|TWO_SIDED|95.0|-0.3|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(113) = -2.18, d = 0.03.||-0.02|-0.30|0.03
91676845|NCT03056157|183248398|SUPERIORITY||Slope|0.05||||0.48|TWO_SIDED|95.0|-0.09|0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.70, d = 0.13.||0.20|-0.09|0.48
91676846|NCT03056157|183248399|SUPERIORITY||Slope|0.7||||0.45|TWO_SIDED|95.0|-1.12|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = 0.76, d = 0.09.||2.52|-1.12|0.45
91676847|NCT03056157|183248399|SUPERIORITY||Slope|-1.2||||0.08|TWO_SIDED|95.0|-2.52|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -1.79, d = 0.34.||0.12|-2.52|0.08
91676848|NCT03056157|183248399|SUPERIORITY||Slope|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.66|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -3.00, d = 0.56.||-0.66|-3.15|0.003
91676849|NCT03056157|183248399|SUPERIORITY||standardized effect size of the slope|-0.29||||0.7|TWO_SIDED|95.0|-1.75|1.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.39, d = 0.04.||1.17|-1.75|0.70
91676850|NCT03056157|183248399|SUPERIORITY||Slope|-0.59||||0.27|TWO_SIDED|95.0|-1.64|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -1.11, d = 0.12.||0.46|-1.64|0.27
91676851|NCT03056157|183248399|SUPERIORITY||Slope|-0.29||||0.57|TWO_SIDED|95.0|-1.32|0.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.57, d = 0.06.||0.72|-1.32|0.57
91676852|NCT03056157|183248400|SUPERIORITY||Slope|3.41||||0.02|TWO_SIDED|95.0|0.56|6.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 2.35, d = 0.26.||6.25|0.56|0.02
91676853|NCT03056157|183248400|SUPERIORITY||Slope|6.84|||<|0.001|TWO_SIDED|95.0|4.78|8.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = -6.53, d = 1.21.||8.90|4.78|<0.001
91676854|NCT03056157|183248400|SUPERIORITY||Slope|3.43||||0.001|TWO_SIDED|95.0|1.47|5.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = 3.44, d = 0.64.||5.40|1.47|0.001
91676855|NCT03056157|183248400|SUPERIORITY||Slope|0.76||||0.51|TWO_SIDED|95.0|-1.5|3.03|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 0.66, d = 0.07.||3.03|-1.50|0.51
91676856|NCT03056157|183248400|SUPERIORITY||Slope|-0.27||||0.75|TWO_SIDED|95.0|-1.89|1.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -0.32, d = 0.04.||1.35|-1.89|0.75
91676857|NCT03056157|183248400|SUPERIORITY||Slope|-1.03||||0.2|TWO_SIDED|95.0|-2.61|0.55|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -1.28, d = 0.14.||0.55|-2.61|0.20
91676858|NCT03056157|183248401|SUPERIORITY||Slope|0.26||||0.004|TWO_SIDED|95.0|0.08|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 2.93, d = 0.33.||0.43|0.08|0.004
91676859|NCT03056157|183248401|SUPERIORITY||Slope|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 5.56, d = 1.04.||0.48|0.23|<0.001
91676860|NCT03056157|183248401|SUPERIORITY||Slope|0.1||||0.11|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 1.61, d = 0.30.||0.22|-0.02|0.11
91676861|NCT03056157|183248401|SUPERIORITY||Slope|0.007||||0.92|TWO_SIDED|95.0|-0.13|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.10, d = 0.10.||0.15|-0.13|0.92
91676862|NCT03056157|183248401|SUPERIORITY||Slope|0.02||||0.75|TWO_SIDED|95.0|-0.08|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.31, d = 0.03.||0.12|-0.08|0.75
91676863|NCT03056157|183248401|SUPERIORITY||Slope|0.01||||0.86|TWO_SIDED|95.0|-0.09|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.18, d = 0.02.||0.11|-0.09|0.86
91676864|NCT03056157|183248402|SUPERIORITY||Slope|-2.56||||0.15|TWO_SIDED|95.0|-6.1|0.97|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.43, d = 0.16.||0.97|-6.10|0.15
91676865|NCT03056157|183248402|SUPERIORITY||Slope|-5.28|||<|0.001|TWO_SIDED|95.0|-7.83|-2.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -4.07, d = 0.76||-2.73|-7.83|<0.001
91676866|NCT03056157|183248402|SUPERIORITY||Slope|-2.71||||0.03|TWO_SIDED|95.0|-5.16|-0.28|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -2.19, d = 0.41.||-0.28|-5.16|0.03
91676867|NCT03056157|183248402|SUPERIORITY||Slope|-1.38||||0.33|TWO_SIDED|95.0|-4.17|1.42|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.97, d = 0.11.||1.42|-4.17|0.33
91692352|NCT01436370|183279661|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 180.||||0.250
91486671|NCT01881373|182846156|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.90
91486672|NCT01881373|182846157|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.05||||0.71|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.71
91676868|NCT03056157|183248402|SUPERIORITY||Slope|-1.54||||0.13|TWO_SIDED|95.0|-3.54|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.51, d = 0.17.||0.46|-3.54|0.13
91676869|NCT03056157|183248402|SUPERIORITY||Slope|-0.17||||0.87|TWO_SIDED|95.0|-2.12|1.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.17, d = 0.02.||1.79|-2.12|0.87
91676870|NCT03056157|183248403|SUPERIORITY||Slope|-0.37||||0.04|TWO_SIDED|95.0|-0.72|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -2.03, d = 0.23.||-0.01|-0.72|0.04
91676871|NCT03056157|183248403|SUPERIORITY||Slope|-0.83|||<|0.001|TWO_SIDED|95.0|-1.09|-0.58|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116)= -6.40, d = 1.19.||-0.58|-1.09|<0.001
91676872|NCT03056157|183248403|SUPERIORITY||Slope|-0.47||||0.002|TWO_SIDED|95.0|-0.71|-0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116) = -3.78, d = 0.70.||-0.22|-0.71|0.002
91676873|NCT03056157|183248403|SUPERIORITY||Slope|-0.08||||0.58|TWO_SIDED|95.0|-0.37|0.21|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.56, d = 0.06.||0.21|-0.37|0.58
91676874|NCT03056157|183248403|SUPERIORITY||Slope|-0.1||||0.34|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.96, d = 0.11.||0.11|-0.31|0.34
91676875|NCT03056157|183248403|SUPERIORITY||Slope|-0.02||||0.85|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.19, d = 0.02.||0.18|-0.22|0.85
91676876|NCT03056157|183248404|SUPERIORITY|We log-transformed CTS2 scores because they were heavily positively skewed in conjunction with zero-inflation.|Slope|-0.23||||0.07|TWO_SIDED|95.0|-0.48|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319)= -1.82, d = 0.20.||0.02|-0.48|0.07
91676877|NCT03056157|183248404|SUPERIORITY||Slope|-0.13||||0.17|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = -1.39, d = 0.16.||-0.05|-0.31|0.17
91676878|NCT03056157|183248404|SUPERIORITY||Slope|0.1||||0.24|TWO_SIDED|95.0|-0.07|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = 1.18, d = 0.13.||0.27|-0.07|0.24
91676879|NCT03056157|183248404|SUPERIORITY||Slope|0.11||||0.71|TWO_SIDED|95.0|-0.23|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.37, d = 0.04.||0.15|-0.23|0.71
91676880|NCT03056157|183248404|SUPERIORITY||Slope|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -1.00, d = 0.11.||0.07|-0.21|0.32
91676881|NCT03056157|183248404|SUPERIORITY||Slope|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.51, d = 0.06.||0.10|-0.17|0.61
91676882|NCT03056157|183248405|SUPERIORITY||Slope|-0.07||||0.74|TWO_SIDED|95.0|-0.5|0.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(318) = -0.33, d = 0.04||0.36|-0.50|0.74
91676883|NCT03056157|183248405|SUPERIORITY||Slope|-0.12||||0.44|TWO_SIDED|95.0|-0.43|0.19|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.77, d = 0.14.||0.19|-0.43|0.44
91676884|NCT03056157|183248405|SUPERIORITY||Slope|-0.06||||0.74|TWO_SIDED|95.0|-0.35|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.34, d = 0.06.||0.24|-0.35|0.74
91676885|NCT03056157|183248405|SUPERIORITY||Slope|-0.1||||0.57|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.57, d = 0.11.||0.25|-0.45|0.57
91676886|NCT03056157|183248405|SUPERIORITY||Slope|-0.03||||0.82|TWO_SIDED|95.0|-0.28|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.23, d = 0.04.||0.22|-0.28|0.82
91676887|NCT03056157|183248405|SUPERIORITY||Slope|0.07||||0.57|TWO_SIDED|95.0|-0.17|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = 0.58, d = 0.11.||0.31|-0.17|0.57
91676888|NCT03056157|183248406|SUPERIORITY||Slope|-1.1||||0.16|TWO_SIDED|95.0|-2.63|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -1.42, d = 0.16.||0.43|-2.63|0.16
91676889|NCT03056157|183248406|SUPERIORITY||Slope|-0.76||||0.18|TWO_SIDED|95.0|-1.87|0.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114)= -1.35, d = 0.25.||0.35|-1.87|0.18
91717267|NCT02322749|183327271|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric Least Squares (LS) Mean Ratio|9.32|||||TWO_SIDED|90.0|8.25|10.53|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||10.53|8.25|
91717268|NCT02322749|183327272|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS Mean Ratio|24.26|||||TWO_SIDED|90.0|22.62|26.03|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||26.03|22.62|
91717269|NCT02322749|183327273|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS mean ratio|22.12|||||TWO_SIDED|90.0|20.65|23.69|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||23.69|20.65|
91717270|NCT02322749|183327274|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.93|||||TWO_SIDED|90.0|11.42|14.65|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.65|11.42|
91717271|NCT02322749|183327275|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|26.2|||||TWO_SIDED|90.0|24.44|28.09|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||28.09|24.44|
91717272|NCT02322749|183327276|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|23.6|||||TWO_SIDED|90.0|22.02|25.3|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||25.30|22.02|
91717273|NCT02322749|183327277|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|9.66|||||TWO_SIDED|90.0|8.5|10.97|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect|||10.97|8.5|
91717274|NCT02322749|183327277|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|13.04|||||TWO_SIDED|90.0|11.45|14.86|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.86|11.45|
91717275|NCT02322749|183327278|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|11.31|||||TWO_SIDED|90.0|9.8|13.05|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||13.05|9.80|
91717276|NCT02322749|183327278|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.8|||||TWO_SIDED|90.0|11.07|14.8|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.80|11.07|
91717277|NCT01409239|183327279|SUPERIORITY_OR_OTHER|||||||0.05||||||Wilcoxon rank-sum was used to determine differences between groups.|Wilcoxon (Mann-Whitney)|||Since this was a pilot study no formal power analysis was possible. It was hypothesized that IV insulin would be associated with lower LF/HF HRV.||||0.05
91717278|NCT04265261|183327289|SUPERIORITY||Risk Difference (RD)|1.19||||0.8586|TWO_SIDED|95.0|-11.86|14.23|||Cochran-Mantel-Haenszel|||||14.23|-11.86|0.8586
91717279|NCT04265261|183327289|SUPERIORITY||Risk Difference (RD)|-2.93||||0.6388|TWO_SIDED|95.0|-15.18|9.31|||Cochran-Mantel-Haenszel|||||9.31|-15.18|0.6388
91717280|NCT02669849|183327310|SUPERIORITY||Least Squares (LS) Mean Difference|-0.69||||0.7519|TWO_SIDED|95.0|-5.08|3.69|||Mixed-effects model for repeated measure|||||3.69|-5.08|0.7519
91717281|NCT02369653|183327348|SUPERIORITY|||||||0.0403|||||||Cochran-Mantel-Haenszel|||||||0.0403
91717282|NCT02369653|183327349|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
91717283|NCT01587885|183327369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.548|||<|0.048|||||||Regression, Cox|||||||<0.0480
91717284|NCT01603602|183327414|SUPERIORITY||Least Squares (LS) Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.938|-0.379||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|Mixed Model Repeated Measures (MMRM)|||||-0.379|-0.938|<0.001
91717285|NCT01603602|183327414|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.992|-0.426||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||-0.426|-0.992|<0.001
91717286|NCT01603602|183327415|SUPERIORITY||LS Mean Difference|0.21||||0.155|TWO_SIDED|95.0|-0.082|0.511||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.511|-0.082|0.155
91717287|NCT01603602|183327415|SUPERIORITY||LS Mean Difference|0.22||||0.147|TWO_SIDED|95.0|-0.079|0.523||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.523|-0.079|0.147
91676890|NCT03056157|183248406|SUPERIORITY||Slope|0.34||||0.53|TWO_SIDED|95.0|-0.71|1.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 0.63, d = 0.12.||1.39|-0.71|0.53
91486673|NCT01881373|182846158|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|||||intervention vs control communities|Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.48
91486674|NCT01881373|182846159|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|differences in prevalence|-3.6|||<|0.01|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|Hierarchical model||intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||<0.01
91486675|NCT01881373|182846160|SUPERIORITY|Hierarchical|Mean Difference (Final Values)|0.09||||0.44|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.44
91486676|NCT01881373|182846161|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.16||||0.81|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.81
91486677|NCT01881373|182846162|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.37||||0.68|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.68
91486678|NCT01881373|182846163|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.69
91486679|NCT01881373|182846164|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.21||||0.11|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.11
91486680|NCT01881373|182846165|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.06||||0.4|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|||Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.40
91486681|NCT01881373|182846166|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.37
91526729|NCT02912468|182928751|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.61|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.17||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.17|-3.04|<.0001
91527553|NCT04249336|182930405|SUPERIORITY||Mean Difference (Net)|39.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
91676891|NCT03056157|183248406|SUPERIORITY||Slope|-0.6||||0.37|TWO_SIDED|95.0|-1.93|0.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -0.89, d = 0.12.||0.73|-1.93|.37
91676892|NCT03056157|183248406|SUPERIORITY||Slope|-0.04||||0.94|TWO_SIDED|95.0|-1.0|0.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = -0.08, d = 0.02.||0.92|-1.00|0.94
91692353|NCT01436370|183279661|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.||||0.145
91527554|NCT04249336|182930405|SUPERIORITY||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
91676893|NCT03056157|183248406|SUPERIORITY||Slope|0.57||||0.23|TWO_SIDED|95.0|-0.35|1.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 1.21, d = 0.23.||1.48|-0.35|0.23
91676894|NCT03056157|183248407|SUPERIORITY||Slope|3.98||||0.01|TWO_SIDED|95.0|0.83|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 2.49, d = 0.28.||7.13|0.83|0.01
91676895|NCT03056157|183248407|SUPERIORITY||Slope|4.84|||<|0.001|TWO_SIDED|95.0|2.55|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 4.16, d = 0.78.||7.13|2.55|<0.001
91676896|NCT03056157|183248407|SUPERIORITY||Slope|0.85||||0.44|TWO_SIDED|95.0|-1.31|3.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 0.78, d = 0.15.||3.02|-1.31|0.44
91676897|NCT03056157|183248407|SUPERIORITY||Slope|0.21||||0.88|TWO_SIDED|95.0|-2.32|2.75|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.17, d = 0.02.||2.75|-2.32|0.88
91676898|NCT03056157|183248407|SUPERIORITY||Slope|0.55||||0.55|TWO_SIDED|95.0|-1.27|2.37|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.60, d = 0.07.||2.37|-1.27|0.55
91676899|NCT03056157|183248407|SUPERIORITY||Slope|0.38||||0.7|TWO_SIDED|95.0|-1.42|2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.38, d = 0.04.||2.10|-1.42|0.70
91676900|NCT03056157|183248408|SUPERIORITY||Slope|-0.04||||0.8|TWO_SIDED|95.0|-0.32|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(318) = -0.25, d = 0.03.||0.25|-0.32|0.80
91676901|NCT03056157|183248408|SUPERIORITY||Slope|0.04||||0.57|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = 0.57, d = 0.11.||0.16|-0.09|0.57
91676902|NCT03056157|183248408|SUPERIORITY||Slope|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = -0.23, d = 0.04.||0.11|-0.14|0.82
91676903|NCT03056157|183248408|SUPERIORITY||Slope|0.05||||0.57|TWO_SIDED|95.0|-0.13|0.23|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(320) = 0.57, d = 0.06.||0.23|-0.13|0.57
91676904|NCT03056157|183248409|SUPERIORITY||Slope|3.91||||0.002|TWO_SIDED|95.0|1.48|6.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 3.16, d = 0.32.||6.35|1.48|0.002
91676905|NCT03056157|183248409|SUPERIORITY||Slope|4.16|||<|0.001|TWO_SIDED|95.0|2.41|5.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 4.66, d = 0.85.||5.92|2.41|<0.001
91676906|NCT03056157|183248409|SUPERIORITY||Slope|0.25||||0.78|TWO_SIDED|95.0|-1.44|1.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 0.63, d = 0.11.||1.94|-1.44|0.78
91676907|NCT03056157|183248409|SUPERIORITY||Slope|-0.05||||0.73|TWO_SIDED|95.0|-0.34|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = -0.34, d = 0.01.||0.24|-0.34|0.73
91717288|NCT01603602|183327416|SUPERIORITY||LS Mean Difference|-0.39||||0.111|TWO_SIDED|95.0|-0.861|0.091||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.091|-0.861|0.111
91676908|NCT03056157|183248409|SUPERIORITY||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.15|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 0.56, d = 0.06.||0.27|-0.15|0.58
91676909|NCT03056157|183248409|SUPERIORITY||Slope|0.11||||0.28|TWO_SIDED|95.0|-0.1|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 1.07, d = 0.11.||0.31|-0.10|0.28
91676910|NCT00140426|183248415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.55|TWO_SIDED|95.0|0.41|1.74|||Regression, Cox|Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.|The hazard ratio is for the placebo group versus the treatment group. A hazard ratio \<1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.|||1.74|0.41|0.55
91676911|NCT00140426|183248419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_DEVIATION|3.74||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
91676912|NCT00140426|183248419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.45|STANDARD_DEVIATION|20.88|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91676913|NCT00140426|183248421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.26||0.47|TWO_SIDED|95.0|-0.71|0.33|||t-test, 2 sided||The mean difference was for placebo - risperidone.|Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score||0.33|-0.71|0.47
91676914|NCT00140426|183248422|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
91676915|NCT00140426|183248423|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
91676916|NCT00140426|183248424|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
91676917|NCT00140426|183248425|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
91676918|NCT02149108|183248426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.49|0.69||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio \<1 favors Nintedanib.|||0.69|0.49|<0.0001
91676919|NCT02149108|183248427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8659|TWO_SIDED|95.0|0.86|1.19||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio below 1 favors Nintedanib.|||1.19|0.86|0.8659
91676920|NCT02149108|183248429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|2.0|4.47||Odds ratio and p-value are obtained from logistic regression model adjusted for regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.|Regression, Logistic||An odds ratio \>1 indicates benefit to Nintedanib.|||4.47|2.00|<0.0001
91526730|NCT02912468|182928752|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.56|||<|0.0001|TWO_SIDED|95.0|8.79|12.34||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.34|8.79|<.0001
91717289|NCT01603602|183327416|SUPERIORITY||LS Mean Difference|-0.44||||0.078|TWO_SIDED|95.0|-0.933|0.051||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.051|-0.933|0.078
91717290|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|-0.1||||0.636|TWO_SIDED|95.0|-0.498|0.305||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.305|-0.498|0.636
91717291|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|-0.09||||0.658|TWO_SIDED|95.0|-0.502|0.318||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.318|-0.502|0.658
91526731|NCT02912468|182928753|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.93||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.93|-1.31|<.0001
91526732|NCT02912468|182928754|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.12|||<|0.0001|TWO_SIDED|95.0|-25.17|-17.06||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.06|-25.17|<.0001
91526733|NCT01515189|182928785|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.7|0.99||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||0.99|0.70|0.0400
91676921|NCT04168190|183248435|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|-10.0|||||TWO_SIDED|95.0|-29.3|9.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site erythema||9.0|-29.3|
91676922|NCT04168190|183248435|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-18.1|24.6|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site erythema||24.6|-18.1|
91676923|NCT04168190|183248435|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-7.7|39.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site pain||39.3|-7.7|
91676924|NCT04168190|183248435|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|20.0|||||TWO_SIDED|95.0|-4.1|42.1|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site pain||42.1|-4.1|
91717292|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|0.24||||0.243|TWO_SIDED|95.0|-0.162|0.635||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.635|-0.162|0.243
91676925|NCT04168190|183248435|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|6.7|||||TWO_SIDED|95.0|-13.2|26.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site swelling||26.5|-13.2|
91676926|NCT04168190|183248435|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-16.0|22.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site swelling||22.8|-16.0|
91676927|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
91717293|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|0.17||||0.412|TWO_SIDED|95.0|-0.237|0.576||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.576|-0.237|0.412
91676928|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
91676929|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-7.4|28.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Arthralgia||28.3|-7.4|
91676930|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-13.1|20.2|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Arthralgia||20.2|-13.1|
91676931|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-7.5|33.8|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Myalgia||33.8|-7.5|
91526734|NCT01515189|182928786|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1548|TWO_SIDED|95.0|0.76|1.04||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||1.04|0.76|0.1548
91526735|NCT01515189|182928792|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases.|||1.04|0.49|
91676932|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-4.6|37.3|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Myalgia||37.3|-4.6|
91676933|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-8.5|34.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Headache||34.5|-8.5|
91676934|NCT04168190|183248436|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-17.2|23.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Headache||23.8|-17.2|
91676935|NCT04168190|183248437|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
91676936|NCT04168190|183248437|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
91676937|NCT04168190|183248438|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|2.0|||||TWO_SIDED|95.0|-2.8|6.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site erythema||6.8|-2.8|
91676938|NCT04168190|183248438|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|8.7|||||TWO_SIDED|95.0|0.1|17.1|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site pain||17.1|0.1|
91676939|NCT04168190|183248438|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.1|||||TWO_SIDED|95.0|-2.0|8.4|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site swelling||8.4|-2.0|
91676940|NCT04168190|183248439|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|7.1|||||TWO_SIDED|95.0|0.8|13.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Fatigue||13.5|0.8|
91526736|NCT02541383|182928803|SUPERIORITY||Odds Ratio (OR)|1.6||||0.001|TWO_SIDED|95.0|1.21|2.12|||Cochran-Mantel-Haenszel|||||2.12|1.21|0.0010
91676941|NCT04168190|183248439|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Arthralgia||3.8|-3.8|
91676942|NCT04168190|183248439|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.8|7.0|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Myalgia||7.0|-3.8|
91676943|NCT04168190|183248439|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|9.9|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Headache||9.9|-2.7|
91676944|NCT04168190|183248440|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.5|1.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|||1.5|-1.5|
91676945|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.82|1.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.22|0.82|<0.001
91676946|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|0.95|1.56|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.56|0.95|<0.001
91676947|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.9|1.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.41|0.90|<0.001
91676948|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.58|||<|0.001|TWO_SIDED|95.0|1.16|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.16|<0.001
91676949|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.24|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.24|0.71|<0.001
91692354|NCT01436370|183279661|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.||||0.500
91692355|NCT01436370|183279661|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.999
91526737|NCT02541383|182928804|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Log Rank|||||0.68|0.42|<0.0001
91526738|NCT02541383|182928805|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.52|0.72|||Log Rank|||||0.72|0.52|<0.0001
91526739|NCT01960530|182928856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|60.12|||||TWO_SIDED|90.0|54.69|66.1||||||Evaluation of Cmax||66.10|54.69|
91676950|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.8|1.21|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.21|0.80|<0.001
91676951|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.87|1.47|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.47|0.87|<0.001
91676952|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|0.93|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.93|<0.001
91676953|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.78|2.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.90|1.78|<0.001
91676954|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.57|||<|0.001|TWO_SIDED|95.0|1.86|3.55|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.55|1.86|<0.001
91676955|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.24|<0.001
91676956|NCT04168190|183248441|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.43|2.36|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.36|1.43|<0.001
91676957|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.03|||<|0.001|TWO_SIDED|95.0|4.23|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|4.23|<0.001
91676958|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.8|||<|0.001|TWO_SIDED|95.0|5.37|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|5.37|<0.001
91676959|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.31|3.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.90|2.31|<0.001
91676960|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|18.21|||<|0.001|TWO_SIDED|95.0|12.98|25.57|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||25.57|12.98|<0.001
91676961|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|19.45|||<|0.001|TWO_SIDED|95.0|12.87|29.4|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.40|12.87|<0.001
91676962|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|29.88|||<|0.001|TWO_SIDED|95.0|20.72|43.09|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||43.09|20.72|<0.001
91692356|NCT01436370|183279661|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.500
91692357|NCT01436370|183279662|SUPERIORITY_OR_OTHER|||||||0.716|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.||||0.716
91676963|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|32.02|||<|0.001|TWO_SIDED|95.0|22.83|44.89|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||44.89|22.83|<0.001
91676964|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|34.9|||<|0.001|TWO_SIDED|95.0|24.25|50.23|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||50.23|24.25|<0.001
91676965|NCT04168190|183248442|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|9.0|||<|0.001|TWO_SIDED|95.0|7.19|11.26|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||11.26|7.19|<0.001
91676966|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.58|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.42|0.58|
91676967|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.71|1.76|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.76|0.71|
91676968|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.63|1.99|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.99|0.63|
91676969|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.19|3.84|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||3.84|1.19|
91676970|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.27|||||TWO_SIDED|95.0|0.74|2.21|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||2.21|0.74|
91676971|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.08|||||TWO_SIDED|95.0|1.19|3.63|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||3.63|1.19|
91676972|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.37|1.46|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||1.46|0.37|
91676973|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.5|2.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||2.00|0.50|
91676974|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.4|1.41|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.41|0.40|
91676975|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.32|||||TWO_SIDED|95.0|0.7|2.48|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||2.48|0.70|
91676976|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.37|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.37|
91676977|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.58|1.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.69|0.58|
91676978|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.57|1.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||1.85|0.57|
91676979|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|0.9|2.97|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.97|0.90|
91676980|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.25|||||TWO_SIDED|95.0|0.67|2.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.32|0.67|
91676981|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.84|||||TWO_SIDED|95.0|0.98|3.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.45|0.98|
91676982|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.42|1.38|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.38|0.42|
91676983|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.59|||||TWO_SIDED|95.0|0.87|2.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||2.91|0.87|
91676984|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.5|2.17|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||2.17|0.50|
91692358|NCT01436370|183279662|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.||||0.999
91486682|NCT01881373|182846166|SUPERIORITY|Hierarchical model.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.18||||0.51|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.51
91486683|NCT01366417|182846168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|0.133|<|0.05|TWO_SIDED|95.0|1.95|2.48|||ANOVA|||Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm\^2 at 30 seconds after application.||2.48|1.95|< 0.05
91486684|NCT01366417|182846168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|1.99|2.51|||ANOVA|||hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm\^2 at 30 seconds after treatment||2.51|1.99|<0.05
91676985|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.02|4.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.50|1.02|
91676986|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.11|||||TWO_SIDED|95.0|1.21|3.68|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.68|1.21|
91676987|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.87|||||TWO_SIDED|95.0|1.64|5.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||5.03|1.64|
91676988|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.65|||||TWO_SIDED|95.0|0.93|2.93|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||2.93|0.93|
91676989|NCT04168190|183248443|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.07|3.43|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||3.43|1.07|
91676990|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.29|||||TWO_SIDED|95.0|1.99|9.25|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||9.25|1.99|
91676991|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.49|||||TWO_SIDED|95.0|2.53|11.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||11.91|2.53|
91676992|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.05|||||TWO_SIDED|95.0|2.59|9.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||9.85|2.59|
91676993|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|4.55|17.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||17.50|4.55|
91676994|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.4|||||TWO_SIDED|95.0|2.38|8.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||8.15|2.38|
91676995|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.92|||||TWO_SIDED|95.0|2.64|9.16|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||9.16|2.64|
91676996|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.41|||||TWO_SIDED|95.0|1.97|5.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||5.91|1.97|
91676997|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|6.58|||||TWO_SIDED|95.0|3.78|11.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.45|3.78|
91676998|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.42|||||TWO_SIDED|95.0|4.35|20.4|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||20.40|4.35|
91676999|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.46|||||TWO_SIDED|95.0|4.34|20.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||20.62|4.34|
91677000|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|1.95|6.05|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||6.05|1.95|
91677001|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.77|||||TWO_SIDED|95.0|2.69|8.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||8.45|2.69|
91677002|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.06|||||TWO_SIDED|95.0|3.36|19.35|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||19.35|3.36|
91677003|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|16.14|||||TWO_SIDED|95.0|6.68|39.01|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||39.01|6.68|
91692359|NCT01436370|183279662|SUPERIORITY_OR_OTHER|||||||0.503|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.||||0.503
91692360|NCT01436370|183279662|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.||||0.475
91486685|NCT01366417|182846169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.65|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.39|2.91|||ANOVA|||Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.||2.91|2.39|<0.05
91677004|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.14|||||TWO_SIDED|95.0|4.93|16.95|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||16.95|4.93|
91677005|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|13.58|||||TWO_SIDED|95.0|7.28|25.32|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||25.32|7.28|
91677006|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.24|||||TWO_SIDED|95.0|5.56|15.36|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||15.36|5.56|
91677007|NCT04168190|183248444|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|12.5|||||TWO_SIDED|95.0|7.49|20.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||20.87|7.49|
91677008|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.67|1.47|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.47|0.67|
91677009|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.72|1.57|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.57|0.72|
91677010|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.88||||||95.0|0.54|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.42|0.54|
91677011|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.68|1.8|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||1.80|0.68|
91677012|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.59|1.54|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||1.54|0.59|
91677013|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.32|||||TWO_SIDED|95.0|0.81|2.15|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||2.15|0.81|
91677014|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.65|||||TWO_SIDED|95.0|0.85|3.23|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||3.23|0.85|
91677015|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.01|||||TWO_SIDED|95.0|1.03|3.96|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||3.96|1.03|
91677016|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.44|1.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.67|0.44|
91486686|NCT01366417|182846169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.6|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.33|2.86|||ANOVA|||Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment||2.86|2.33|<0.05
91486687|NCT00165984|182846181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.9||||0.003|TWO_SIDED|95.0|1.7|13.9|||Regression, Cox|||||13.9|1.7|0.003
91486688|NCT01686828|182846184|SUPERIORITY_OR_OTHER|||||||0.164||||||The a prior threshold for statistical significance was p\<0.05.|RM-ANOVA|||||||0.164
91486689|NCT01686828|182846185|SUPERIORITY_OR_OTHER|||||||0.003|||||||RM-ANOVA|||Time-by-group interaction for fat mass||||0.003
91486690|NCT01686828|182846185|SUPERIORITY_OR_OTHER|||||||0.03||||||Time-by-group interaction for lean mass|RM-ANOVA|||||||0.03
91677017|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|0.97|3.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||3.69|0.97|
91677018|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.46|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.46|
91677019|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.58|1.38|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.38|0.58|
91677020|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.62|2.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||2.15|0.62|
91677021|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.58|2.04|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.04|0.58|
91677022|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.9|2.71|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.71|0.90|
91677023|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.87|||||TWO_SIDED|95.0|1.08|3.23|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.23|1.08|
91677024|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.53|1.49|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.49|0.53|
91717294|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|-0.02||||0.904|TWO_SIDED|95.0|-0.408|0.361||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.361|-0.408|0.904
91717295|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|-0.25||||0.2|TWO_SIDED|95.0|-0.641|0.135||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.135|-0.641|0.200
91717296|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|0.59||||0.003|TWO_SIDED|95.0|0.21|0.978||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.978|0.210|0.003
91717297|NCT01603602|183327417|SUPERIORITY||LS Mean Difference|0.19||||0.327|TWO_SIDED|95.0|-0.194|0.58||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.580|-0.194|0.327
91717298|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|12.1||||0.117|TWO_SIDED|95.0|-3.089|27.293||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||27.293|-3.089|0.117
91717299|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|8.41||||0.273|TWO_SIDED|95.0|-6.717|23.527||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||23.527|-6.717|0.273
91717300|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|14.71||||0.015|TWO_SIDED|95.0|2.958|26.458||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||26.458|2.958|0.015
91717301|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|11.85||||0.046|TWO_SIDED|95.0|0.203|23.504||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||23.504|0.203|0.046
91717302|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|20.97|||<|0.001|TWO_SIDED|95.0|8.801|33.137||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||33.137|8.801|<0.001
91717303|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|11.35||||0.064|TWO_SIDED|95.0|-0.662|23.362||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||23.362|-0.662|0.064
91717304|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|15.25||||0.013|TWO_SIDED|95.0|3.317|27.178||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||27.178|3.317|0.013
91717305|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|7.22||||0.225|TWO_SIDED|95.0|-4.488|18.934||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||18.934|-4.488|0.225
91486691|NCT01686828|182846186|OTHER||||||>|0.1|||||||ANOVA|||The null hypothesis was that short-term testosterone deprivation would not affect lipoprotein lipase expression in adipose tissue. Repeated measures ANOVA was used to determine if a time-by-group effect was apparent for lipoprotein lipase expression.||||>0.1
91677025|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.66|1.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||1.87|0.66|
91717306|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|4.5||||0.409|TWO_SIDED|95.0|-6.239|15.236||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||15.236|-6.239|0.409
91677026|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.89|3.27|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||3.27|0.89|
91717307|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|3.86||||0.47|TWO_SIDED|95.0|-6.69|14.419||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||14.419|-6.690|0.470
91717308|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-6.13||||0.263|TWO_SIDED|95.0|-16.962|4.706||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||4.706|-16.962|0.263
91526740|NCT01960530|182928856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|106.83|||||TWO_SIDED|90.0|96.92|117.76||||||||117.76|96.92|
91677027|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.24|4.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.62|1.24|
91486692|NCT04916769|182846230|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of ajusted geometric means|106.27|||||TWO_SIDED|90.0|97.76|115.53||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.53|97.76|
91677028|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.97|||||TWO_SIDED|95.0|1.16|3.34|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.34|1.16|
91677029|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.06|||||TWO_SIDED|95.0|1.21|3.51|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||3.51|1.21|
91677030|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.77|1.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||1.91|0.77|
91677031|NCT04168190|183248445|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.99|2.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||2.45|0.99|
91677032|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.98|||||TWO_SIDED|95.0|5.9|33.1|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||33.10|5.90|
91677033|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|14.42|||||TWO_SIDED|95.0|6.05|34.35|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||34.35|6.05|
91677034|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.39||||||95.0|4.29|12.75|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||12.75|4.29|
91677035|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|9.4|||||TWO_SIDED|95.0|5.42|16.28|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||16.28|5.42|
91677036|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.13|||||TWO_SIDED|95.0|1.25|3.63|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||3.63|1.25|
91677037|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.64|4.79|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||4.79|1.64|
91677038|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|3.79|||||TWO_SIDED|95.0|1.88|7.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||7.67|1.88|
91526741|NCT01960530|182928861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.99|||||TWO_SIDED|90.0|79.23|95.52||||||||95.52|79.23|
91526742|NCT01960530|182928861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|89.96|||||TWO_SIDED|90.0|81.72|99.04||||||||99.04|81.72|
91677039|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|5.87|||||TWO_SIDED|95.0|2.88|11.94|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.94|2.88|
91677040|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.76|||||TWO_SIDED|95.0|5.68|33.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||33.32|5.68|
91677041|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.28|||||TWO_SIDED|95.0|7.91|47.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||47.00|7.91|
91677042|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|23.85|||||TWO_SIDED|95.0|8.64|65.82|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||65.82|8.64|
91677043|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|39.39|||||TWO_SIDED|95.0|14.15|109.65|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||109.65|14.15|
91677044|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.88|||||TWO_SIDED|95.0|9.03|43.74|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||43.74|9.03|
91677045|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|31.07|||||TWO_SIDED|95.0|13.98|69.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||69.03|13.98|
91486693|NCT04916769|182846230|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|101.93|||||TWO_SIDED|90.0|93.97|110.56||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.56|93.97|
91677046|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|57.79|||||TWO_SIDED|95.0|25.15|132.78|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||132.78|25.15|
91677047|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|58.07|||||TWO_SIDED|95.0|25.1|134.33|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||134.33|25.10|
91677048|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|6.93|||||TWO_SIDED|95.0|4.45|10.8|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||10.80|4.45|
91677049|NCT04168190|183248446|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.82|||||TWO_SIDED|95.0|5.0|12.24|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||12.24|5.00|
91677050|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.30|0.90|<0.001
91677051|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.23|||<|0.001|TWO_SIDED|95.0|0.99|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.99|<0.001
91677052|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.02|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|1.02|<0.001
91677053|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.06|1.75|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.75|1.06|<0.001
91677054|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.69|1.06|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.06|0.69|<0.001
91677055|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.78|1.18|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.18|0.78|<0.001
91677056|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.3|||<|0.001|TWO_SIDED|95.0|1.04|1.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.64|1.04|<0.001
91677057|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.44|2.32|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.32|1.44|<0.001
91677058|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.27|1.86|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.86|1.27|<0.001
91677059|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.75|3.04|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.04|1.75|<0.001
91692361|NCT01436370|183279662|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.182
91692362|NCT01436370|183279662|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.014
91486694|NCT04916769|182846231|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|96.82|||||TWO_SIDED|90.0|86.37|108.53||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||108.53|86.37|
91717309|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-14.6||||0.012|TWO_SIDED|95.0|-25.846|-3.36||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||-3.360|-25.846|0.012
91717310|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-10.64||||0.098|TWO_SIDED|95.0|-23.277|1.996||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||1.996|-23.277|0.098
91717311|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-13.1||||0.051|TWO_SIDED|95.0|-26.26|0.068||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||0.068|-26.260|0.051
91717312|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-17.11||||0.01|TWO_SIDED|95.0|-30.031|-4.189||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||-4.189|-30.031|0.010
91717313|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-11.25||||0.098|TWO_SIDED|95.0|-24.622|2.131||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||2.131|-24.622|0.098
91717314|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-17.71||||0.005|TWO_SIDED|95.0|-29.888|-5.537||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-5.537|-29.888|0.005
91717315|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-15.74||||0.015|TWO_SIDED|95.0|-28.293|-3.194||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-3.194|-28.293|0.015
91717316|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-15.25||||0.02|TWO_SIDED|95.0|-28.01|-2.492||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-2.492|-28.010|0.020
91526743|NCT01022073|182928871|SUPERIORITY_OR_OTHER|||||||0.808|||||||t-test, 2 sided|This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.||||||0.808
91526744|NCT02395133|182928900|SUPERIORITY||Percent Change Difference|-14.83|||=|0.0001|TWO_SIDED|95.0|-22.34|-7.33|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-7.33|-22.34|= 0.0001
91717317|NCT01603602|183327418|SUPERIORITY||LS Mean Difference|-13.52||||0.046|TWO_SIDED|95.0|-26.797|-0.243||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-0.243|-26.797|0.046
91489396|NCT02484690|182851576|SUPERIORITY||Difference in Least Squares Means|-6.35||||0.5185|TWO_SIDED|80.0|-19.0|6.27||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||6.27|-19.0|0.5185
91717318|NCT00316004|183327426|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.55
91717319|NCT00316004|183327427|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.||||0.59
91717320|NCT00316004|183327428|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations.||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.67
91486695|NCT04916769|182846231|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|95.39|||||TWO_SIDED|90.0|85.34|106.61||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||106.61|85.34|
91677060|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.82|||<|0.001|TWO_SIDED|95.0|1.49|2.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.22|1.49|<0.001
91677061|NCT04168190|183248449|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.81|2.83|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.83|1.81|<0.001
91677062|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.77|||<|0.001|TWO_SIDED|95.0|2.95|4.84|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.84|2.95|<0.001
91677063|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.68|||<|0.001|TWO_SIDED|95.0|6.12|9.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||9.64|6.12|<0.001
91677064|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.29|||<|0.001|TWO_SIDED|95.0|2.6|4.17|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.17|2.60|<0.001
91677065|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|8.65|||<|0.001|TWO_SIDED|95.0|7.19|10.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||10.41|7.19|<0.001
91677066|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.83|||<|0.001|TWO_SIDED|95.0|6.2|9.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model||9.90|6.20|<0.001
91677067|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|5.61|||<|0.001|TWO_SIDED|95.0|4.53|6.94|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||6.94|4.53|<0.001
91677068|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|23.99|||<|0.001|TWO_SIDED|95.0|19.35|29.74|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.74|19.35|<0.001
91677069|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|10.13|||<|0.001|TWO_SIDED|95.0|8.32|12.33|||P-value was estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||12.33|8.32|<0.001
91677070|NCT04168190|183248450|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|18.29|||<|0.001|TWO_SIDED|95.0|15.59|21.45|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||21.45|15.59|<0.001
91677071|NCT01675661|183248456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.985|TWO_SIDED|95.0|0.63|1.59|||Regression, Logistic|OR=1.00||For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.||1.59|0.63|0.985
91677072|NCT02992418|183248492|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (\>) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|0.848|||||TWO_SIDED|95.0|0.721|0.997||||||Anti-PT||0.997|0.721|
91486696|NCT04916769|182846232|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|106.23|||||TWO_SIDED|90.0|97.54|115.68||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||115.68|97.54|
91486697|NCT04916769|182846232|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|93.95|110.91||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.91|93.95|
91486698|NCT04941456|182846239|SUPERIORITY||Mean Difference (Final Values)|-26.08||||0.2795|TWO_SIDED|95.0|-74.8|22.63|||t-test, 2 sided|Paired t-test||||22.63|-74.80|0.2795
91677073|NCT02992418|183248492|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.892|1.18||||||Anti-FHA||1.18|0.892|
91486699|NCT04941456|182846242|SUPERIORITY||Mean Difference (Final Values)|-0.6957||||0.3416|TWO_SIDED|95.0|-2.179|0.7877|||t-test, 2 sided|Paired t-test||||0.7877|-2.179|0.3416
91486700|NCT02718300|182846277|SUPERIORITY|||||||0.4046|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.4046
91486701|NCT02718300|182846279|SUPERIORITY|||||||0.7802|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.7802
91677074|NCT02992418|183248492|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.836|1.46||||||Anti-PRN||1.46|0.836|
91677075|NCT02992418|183248492|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.827|1.33||||||Anti-FIM2+3||1.33|0.827|
91677076|NCT02992418|183248493|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|0.26|||||TWO_SIDED|95.0|-4.53|5.04||||||Anti-D||5.04|-4.53|
91677077|NCT02992418|183248493|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|-0.66|||||TWO_SIDED|95.0|-2.87|1.37||||||Anti-T||1.37|-2.87|
91677078|NCT02992418|183248494|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.862|1.44||||||Serotype 1||1.44|0.862|
91677079|NCT02992418|183248494|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.47||||||Serotype 2||1.47|0.97|
91677080|NCT02992418|183248494|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.925|||||TWO_SIDED|95.0|0.739|1.16||||||Serotype 3||1.16|0.739|
91677081|NCT02992418|183248494|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.644|0.999||||||Serotype 4||0.999|0.644|
91677082|NCT00289536|183248507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1662|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log initial recovery will be the same in each dose group.||||0.1662
91677083|NCT00289536|183248508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0965||||||No adjustments were made for multiple comparisons.|ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log AUC/dose will be the same in each dose group.||||0.0965
91677084|NCT00289536|183248509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean terminal half-life will be the same in each dose group.||||0.5057
91677085|NCT00289536|183248517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7048||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: Relationship of initial recovery to pre-infusion level of VWF:Rco with dose groups combined.||||0.7048
91677086|NCT00289536|183248517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Rco with dose groups combined.||||.0322
91677087|NCT00289536|183248517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Rco with dose groups combined.||||0.0056
91677088|NCT00289536|183248518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3696||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of initial recovery to pre-infusion level of VWF:Ag with dose groups combined.||||0.3696
91486702|NCT02718300|182846281|SUPERIORITY|||||||0.6856|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.6856
91486703|NCT02718300|182846283|SUPERIORITY|||||||0.3385|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3385
91717321|NCT00316004|183327429|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.||||0.57
91717322|NCT00316004|183327430|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.||||.84
91717323|NCT00316004|183327431|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.||||0.88
91717324|NCT00316004|183327432|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.||||0.88
91717325|NCT00316004|183327433|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.||||0.91
91717326|NCT00316004|183327434|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.81
91717327|NCT00316004|183327435|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.77
91717328|NCT00316004|183327436|SUPERIORITY_OR_OTHER|||||||0.76||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.||||0.76
91717329|NCT00316004|183327437|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.||||0.43
91717330|NCT00316004|183327438|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.||||0.06
91486704|NCT02718300|182846285|SUPERIORITY|||||||0.4005|||||||Van Elteren test|stratified by Easter Cooperative Oncology Group (ECOG) Performance Status at Screening (0 or 1 versus 2)||||||0.4005
91486705|NCT02718300|182846287|SUPERIORITY|||||||0.3138|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3138
91486706|NCT02718300|182846293|SUPERIORITY|||||||0.3577|||||||ANOVA|||Week 2||||0.3577
91526745|NCT02395133|182928900|SUPERIORITY||Percent Change Difference|-17.83|||<|0.0001|TWO_SIDED|95.0|-25.33|-10.34|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-10.34|-25.33|< 0.0001
91486707|NCT02718300|182846293|SUPERIORITY||Geometric Mean Ratio (GMR)|1.048|||||TWO_SIDED|95.0|0.791|1.388|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.388|0.791|
91486708|NCT02718300|182846293|SUPERIORITY||GMR|1.159|||||TWO_SIDED|95.0|0.936|1.435|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.435|0.936|
91486709|NCT02718300|182846293|SUPERIORITY|||||||0.1709|||||||ANOVA|||Week 4||||0.1709
91486710|NCT02718300|182846293|SUPERIORITY||GMR|1.0|||||TWO_SIDED|95.0|0.78|1.281|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.281|0.780|
91486711|NCT02718300|182846293|SUPERIORITY||GMR|1.176|||||TWO_SIDED|95.0|0.955|1.448|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.448|0.955|
91486712|NCT02718300|182846294|SUPERIORITY|||||||0.6693|||||||Kruskal-Wallis|||Week 2||||0.6693
91486713|NCT02718300|182846294|SUPERIORITY|||||||0.1521|||||||Kruskal-Wallis|||Week 4||||0.1521
91486714|NCT02718300|182846295|SUPERIORITY|||||||0.0809|||||||ANOVA|||Week 2||||0.0809
91717331|NCT00316004|183327438|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.||||0.3
91717332|NCT00316004|183327438|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.||||0.04
91717333|NCT00316004|183327438|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.||||0.06
91717334|NCT00316004|183327438|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.||||0.88
91717335|NCT00316004|183327439|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.||||0.68
91717336|NCT00316004|183327440|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.43
91717337|NCT00316004|183327441|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.||||0.88
91717338|NCT00316004|183327441|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.||||0.26
91717339|NCT00316004|183327441|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.||||0.16
91717340|NCT00316004|183327441|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.||||0.17
91717341|NCT01935089|183327446|OTHER|"Hypothesis: 20 weeks of treatment (baseline week 3 to endpoint week 24) will result in a change in the levels of integrated HIV-1 DNA (copies/CD4 T cell Variable name: intDNA).~Test if the mean difference (IntDNA wk24 - IntDNAwk3) is significantly different from zero (i.e. no change) Null hypothesis: Mean (IntDNA wk24 - IntDNAwk3) = 0; reject if p\<0.05"||||||0.0797||||||significant if \<0.05|signed rank test|||||||0.0797
91486715|NCT02718300|182846295|SUPERIORITY||GMR|0.583|||||TWO_SIDED|95.0|0.342|0.994|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||0.994|0.342|
91717342|NCT02932943|183327447|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6482|TWO_SIDED|95.0|-1.07|1.72|||Mixed Model Repeated Measures (MMRM)|||||1.72|-1.07|0.6482
91486716|NCT02718300|182846295|SUPERIORITY||GMR|0.986|||||TWO_SIDED|95.0|0.658|1.477|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.477|0.658|
91717343|NCT02932943|183327448|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.559|TWO_SIDED|95.0|-1.61|0.87|||Mixed Model Repeated Measures (MMRM)|||||0.87|-1.61|0.5590
91486717|NCT02718300|182846295|SUPERIORITY|||||||0.1525|||||||ANOVA|||Week 4||||0.1525
91486718|NCT02718300|182846295|SUPERIORITY||GMR|1.062|||||TWO_SIDED|95.0|0.604|1.867|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.867|0.604|
91486719|NCT02718300|182846295|SUPERIORITY||GMR|1.504|||||TWO_SIDED|95.0|0.937|2.414|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||2.414|0.937|
91486720|NCT02718300|182846296|SUPERIORITY|||||||0.2873|||||||ANOVA|||Week 2||||0.2873
91486721|NCT02718300|182846296|SUPERIORITY||GMR|1.016|||||TWO_SIDED|95.0|0.773|1.336|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.336|0.773|
91486722|NCT02718300|182846296|SUPERIORITY||GMR|1.161|||||TWO_SIDED|95.0|0.943|1.429|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.429|0.943|
91717344|NCT02932943|183327449|SUPERIORITY||Least Squares Mean Difference|0.2||||0.8131|TWO_SIDED|95.0|-1.53|1.95|||Mixed Model Repeated Measures (MMRM)|||||1.95|-1.53|0.8131
91717345|NCT02932943|183327450|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6108|TWO_SIDED|95.0|-2.05|1.21|||Mixed Model Repeated Measures (MMRM)|||||1.21|-2.05|0.6108
91717346|NCT00977197|183327458|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.008
91717347|NCT00977197|183327459|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.009
91717348|NCT00977197|183327460|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender; rank scale.||||||0.389
91717349|NCT00977197|183327461|SUPERIORITY_OR_OTHER|||||||0.049|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.049
91717350|NCT00977197|183327462|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.044
91717351|NCT00977197|183327463|SUPERIORITY_OR_OTHER|||||||0.35||||||Intent to treat analysis, not adjusted for age and gender.|Chi-squared|||||||0.350
91677089|NCT00289536|183248518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Ag with dose groups combined.||||0.0001
91677090|NCT00289536|183248518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Ag with dose groups combined.||||<0.0001
91677091|NCT03127644|183248538|SUPERIORITY||Treatment difference in slopes|-0.00496|STANDARD_ERROR_OF_MEAN|0.00038|<|0.0001|TWO_SIDED|95.0|-0.00571|-0.0042|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00420|-0.00571|<0.0001
91677092|NCT03127644|183248538|SUPERIORITY||Treatment difference in slopes|-0.00261|STANDARD_ERROR_OF_MEAN|0.000385|<|0.001|TWO_SIDED|95.0|-0.00337|-0.00185|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00185|-0.00337|<0.001
91677093|NCT03127644|183248539|SUPERIORITY||Odds Ratio (OR)|46.495|||<|0.0001|TWO_SIDED|95.0|10.142|213.152|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||213.152|10.142|<0.0001
91677094|NCT03127644|183248539|SUPERIORITY||Odds Ratio (OR)|71.835|||<|0.0001|TWO_SIDED|95.0|13.497|382.337|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||382.337|13.497|<0.0001
91677095|NCT03127644|183248540|SUPERIORITY||Treatment difference in slopes|-0.00231|STANDARD_ERROR_OF_MEAN|0.000645||0.0004|TWO_SIDED|95.0|-0.00359|-0.00104|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00104|-0.00359|0.0004
91677096|NCT03127644|183248540|OTHER||Treatment difference in slopes|-0.00401|STANDARD_ERROR_OF_MEAN|0.000637|<|0.0001|TWO_SIDED|95.0|-0.00527|-0.00275|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00275|-0.00527|<0.0001
91677097|NCT03127644|183248541|SUPERIORITY||Odds Ratio (OR)|1.347||||0.6167|TWO_SIDED|95.0|0.419|4.329|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||4.329|0.419|0.6167
91677098|NCT03127644|183248541|SUPERIORITY||Odds Ratio (OR)|15.334|||<|0.0001|TWO_SIDED|95.0|4.006|58.697|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||58.697|4.006|<0.0001
91677099|NCT03127644|183248545|SUPERIORITY|||||||0.0586||||||Nominal p value|Log Rank|||||||0.0586
91677100|NCT03127644|183248545|SUPERIORITY|||||||0.0006||||||Nominal p value|Log Rank|||||||0.0006
91677101|NCT03127644|183248546|SUPERIORITY|||||||0.025||||||Nominal p value|Log Rank|||||||0.0250
91717352|NCT00977197|183327464|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.020
91677102|NCT03127644|183248546|SUPERIORITY|||||||0.0064||||||Nominal p value|Log Rank|||||||0.0064
91677103|NCT04972123|183248547|SUPERIORITY|The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||||||0.521||||||The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.|Large sample Z-test for population prop|The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||Primary endpoint -- ITT primary endpoint analysis||||0.521
91677104|NCT04972123|183248548|SUPERIORITY|Time to event was compared between groups via a log-rank test.||||||0.574||||||Time to event was compared between groups via a log-rank test.|Log Rank|||Secondary endpoint -- Time to event for evaluable ITT population who had a primary event.||||0.574
91677105|NCT04972123|183248549|SUPERIORITY|Incidence of asystole were compared between groups using Fisher exact test.||||||1||||||Incidence of asystole were compared between groups using Fisher exact test.|Fisher Exact|Incidence of asystole were compared between groups using Fisher exact test.||Secondary endpoint -- Incidence of asystolic pause \> 3 seconds for evaluable ITT population who had a primary event.||||1.000
91677106|NCT04972123|183248550|SUPERIORITY|Reporting for the 1 hour fatigue score only.||||||0.732||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.732
91677107|NCT04972123|183248550|SUPERIORITY|Reporting for the 4 hour fatigue score only.||||||0.591||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.591
91677108|NCT04972123|183248550|SUPERIORITY|Reporting for the 8 hour fatigue score only.||||||0.034||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.034
91677109|NCT01156142|183248561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.7|-2.1|||Wilcoxon (Mann-Whitney)|||||-2.1|-6.7|<0.001
91677110|NCT01156142|183248562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0018|TWO_SIDED|95.0|0.1|5.1|||Wilcoxon (Mann-Whitney)|||||5.1|0.1|0.0018
91677111|NCT01156142|183248563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6||||0.001|TWO_SIDED|95.0|2.9|8.3|||Wilcoxon (Mann-Whitney)|||||8.3|2.9|0.001
91677112|NCT01156142|183248564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.0297|TWO_SIDED|95.0|-1.2|4.6|||Wilcoxon (Mann-Whitney)|||||4.6|-1.2|0.0297
91717353|NCT00977197|183327465|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.024
91677113|NCT01156142|183248565|SUPERIORITY_OR_OTHER|||||||0.1392|||||||Chi-squared|||At 2 hours after initial mouthwash||||0.1392
91677114|NCT01156142|183248565|SUPERIORITY_OR_OTHER|||||||0.6989|||||||Chi-squared|||At 4 hours after initial mouthwash||||0.6989
91486723|NCT02718300|182846296|SUPERIORITY|||||||0.1601|||||||ANOVA|||Week 4||||0.1601
91527555|NCT04249336|182930406|SUPERIORITY||Median Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
91677115|NCT01156142|183248566|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Chi-squared|||||||0.0018
91677116|NCT02337959|183248621|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.028
91677117|NCT02337959|183248622|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05|t-test, 1 sided|||Both the predicate and investigational images were randomized for the monitors. Predicate images could display on the left or the right and vice versa with the investigational. There were formulas in the spreadsheet that gave the preferences a numerical value, and subsequently became part of the analysis.||||0.000
91677118|NCT02623348|183248627|SUPERIORITY||||||<|0.01||||||Threshold for significance: \<0.05|linear mixed modeling|||||||<0.01
91717354|NCT00977197|183327466|SUPERIORITY_OR_OTHER|||||||0.417|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.417
91486724|NCT02718300|182846296|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.773|1.274|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.274|0.773|
91486725|NCT02718300|182846296|SUPERIORITY||GMR|1.177|||||TWO_SIDED|95.0|0.955|1.452|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.452|0.955|
91486726|NCT02718300|182846300|SUPERIORITY|||||||0.083|||||||ANOVA|||Day 1||||0.0830
91486727|NCT02718300|182846300|SUPERIORITY||GMR|1.218|||||TWO_SIDED|95.0|0.846|1.753|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.753|0.846|
91486728|NCT02718300|182846300|SUPERIORITY||GMR|0.957|||||TWO_SIDED|95.0|0.654|1.399|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.399|0.654|
91677119|NCT04647721|183248657|NON_INFERIORITY|Non-inferiority margin of 0.5. The two-sided 95% confidence interval (CI) for the treatment difference was constructed using the repeated-measures analysis of covariance (ANCOVA).|Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.07|0.12||||||||0.12|-0.07|
91677120|NCT04647721|183248658|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.35|6.35||||||||6.35|-6.35|
91677121|NCT04647721|183248659|OTHER||Risk Difference (RD)|1.75|||||TWO_SIDED|95.0|-3.08|6.74||||||||6.74|-3.08|
91677122|NCT04380090|183248661|SUPERIORITY||Odds Ratio (OR)|1.37||||0.41|TWO_SIDED|95.0|0.65|2.86|||Regression, Logistic||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.86|0.65|0.41
91677123|NCT04380090|183248662|SUPERIORITY||Odds Ratio (OR)|0.79||||0.66|TWO_SIDED|95.0|0.28|2.24|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.24|0.28|0.66
91677124|NCT04380090|183248663|SUPERIORITY||Odds Ratio (OR)|1.28||||0.65|TWO_SIDED|95.0|0.45|3.63|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||3.63|0.45|0.65
91677125|NCT04380090|183248664|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.47|||||||Chi-squared|||||||0.47
91677126|NCT04380090|183248665|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.99|||||||Fisher Exact|||||||0.99
91677127|NCT01974440|183248666|SUPERIORITY||Hazard Ratio (HR)|0.806||||0.0922|TWO_SIDED|95.0|0.626|1.037|||Log Rank|||||1.037|0.626|0.0922
91677128|NCT01974440|183248667|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.4505|TWO_SIDED|95.0|0.312|1.682|||Log Rank|||||1.682|0.312|0.4505
91677129|NCT02749292|183248705|EQUIVALENCE|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|0.37||||0.045|TWO_SIDED|95.0|0.15|0.9|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant. Both rows were included and combined in the statistical analysis (ANCA-PR3 and ANCA-MPO) to assess the difference in treatment strategies.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses."||0.90|0.15|0.045
91677130|NCT02749292|183248706|OTHER|chi square test||||||0.87|||||||Chi-squared|||"Null hypothesis: No difference in the proportion of patients with SAEs in each arm"||||0.87
91677131|NCT02749292|183248711|OTHER||||||<|1|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: no difference in the mean number of infusions per patient in each arm.||||<0001
91677132|NCT02749292|183248712|OTHER||Mean Difference (Final Values)|-0.14||||0.17|TWO_SIDED|95.0|-0.34|-0.06|||t-test, 2 sided|||Null hypothesis: there is no difference in the mean change from baseline Vasculitis Damage Index between each arm. A t-test was used.||-0.06|-0.34|0.17
91677133|NCT02749292|183248713|OTHER|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|1.64||||0.42|TWO_SIDED|95.0|0.5|5.36|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses"||5.36|0.50|0.42
91677134|NCT00251641|183248715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|Pearson's chi-square test||The treatment comparison for this endpoint was carried at the 4.9% level of significance.||||<0.001
91677135|NCT00251641|183248716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
91677136|NCT00251641|183248717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
91677137|NCT00251641|183248718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
91677138|NCT00876018|183248719|OTHER|||||||0.004||95.0|||||Mann Whitney U test|||||||0.004
91677139|NCT00876018|183248719|OTHER|||||||0.147||95.0|||||Mann Whitney U test|||||||0.147
91677140|NCT00876018|183248720|OTHER|||||||0.002||95.0|||||Mann Whitney U test|||||||0.002
91677141|NCT00876018|183248720|OTHER|||||||0.003||95.0|||||Mann Whitney U test|||||||0.003
91677142|NCT00876018|183248721|OTHER|||||||0.153||95.0|||||Mann Whitney U test|||||||0.153
91486729|NCT02718300|182846300|SUPERIORITY||GMR|0.943|||||TWO_SIDED|95.0|0.656|1.354|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.354|0.656|
91677143|NCT00876018|183248721|OTHER|||||||0.903||95.0|||||Mann Whitney U test|||||||0.903
91677144|NCT00876018|183248722|OTHER|||||||0.143||95.0|||||Mann Whitney U test|||||||0.143
91677145|NCT00876018|183248722|OTHER|||||||0.678||95.0|||||Mann Whitney U test|||||||0.678
91677146|NCT00888459|183248735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||Chi-squared|||||||.432
91677147|NCT01000493|183248736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.62||||0.3624|TWO_SIDED|95.0|-17.9|6.65||The mixed effects model repeated measures (MMRM) analysis included treatment, week, Baseline total CAPS score and the treatment by week and Baseline. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between Placebo and Orvepitant 60 mg at Week 12.|||6.65|-17.9|0.3624
91677148|NCT01000493|183248737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.3156|TWO_SIDED|95.0|0.54|6.76|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||6.76|0.54|0.3156
91677149|NCT01000493|183248737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.3024|TWO_SIDED|95.0|0.27|1.5|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||1.50|0.27|0.3024
91486730|NCT02718300|182846300|SUPERIORITY||GMR|0.867|||||TWO_SIDED|95.0|0.579|1.298|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.298|0.579|
91486731|NCT02718300|182846300|SUPERIORITY|||||||0.2402|||||||ANOVA|||Week 4||||0.2402
91677150|NCT01000493|183248737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.1208|TWO_SIDED|95.0|0.79|7.28|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 8. Odds ratios represent the odds of improvement, relative to placebo.|||7.28|0.79|0.1208
91677151|NCT01000493|183248737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.1331|TWO_SIDED|95.0|0.7|15.4|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||15.4|0.70|0.1331
91677152|NCT01000493|183248739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.7015|TWO_SIDED|95.0|-5.35|3.61||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||3.61|-5.35|0.7015
91677153|NCT01000493|183248739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.81||||0.4292|TWO_SIDED|95.0|-4.22|9.84||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||9.84|-4.22|0.4292
91486732|NCT02718300|182846300|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.461|1.069|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.069|0.461|
91677154|NCT01000493|183248739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64||||0.3702|TWO_SIDED|95.0|-14.9|5.62||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.62|-14.9|0.3702
91677155|NCT01000493|183248740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.5719|TWO_SIDED|95.0|0.04|5.82|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||5.82|0.04|0.5719
91677156|NCT01000493|183248740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.908||95.0|0.07|20.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||20.1|0.07|0.9080
91486733|NCT02718300|182846300|SUPERIORITY||GMR|0.7|||||TWO_SIDED|95.0|0.456|1.073|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.073|0.456|
91486734|NCT02718300|182846300|SUPERIORITY||GMR|0.638|||||TWO_SIDED|95.0|0.428|0.951|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.951|0.428|
91677157|NCT01000493|183248740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9486|TWO_SIDED|95.0|0.07|12.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||12.5|0.07|0.9486
91677158|NCT01000493|183248742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.5426|TWO_SIDED|95.0|-1.51|2.85||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||2.85|-1.51|0.5426
91677159|NCT01000493|183248742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7552|TWO_SIDED|95.0|-2.73|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||3.75|-2.73|0.7552
91677160|NCT01000493|183248742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.3827|TWO_SIDED|95.0|-7.27|2.83||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||2.83|-7.27|0.3827
91677161|NCT01000493|183248742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98||||0.4915|TWO_SIDED|95.0|-7.71|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.75|-7.71|0.4915
91677162|NCT01000493|183248743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.919|TWO_SIDED|95.0|-1.93|1.74||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||1.74|-1.93|0.9190
91677163|NCT01000493|183248743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.3326|TWO_SIDED|95.0|-1.37|4.0||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||4.00|-1.37|0.3326
91677164|NCT01000493|183248743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9712|TWO_SIDED|95.0|-3.91|3.77||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||3.77|-3.91|0.9712
91677165|NCT01000493|183248743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.6711|TWO_SIDED|95.0|-5.22|3.39||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.39|-5.22|0.6711
91677166|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5532|TWO_SIDED|95.0|0.36|6.92||The analysis method was logistic regression adjusted for Baseline total Clinical Global Impression-Severity of Illness scales (CGI-S) score.|Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||6.92|0.36|0.5532
91677167|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.4508|TWO_SIDED|95.0|0.54|3.93|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||3.93|0.54|0.4508
91677168|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9234|TWO_SIDED|95.0|0.42|2.62|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||2.62|0.42|0.9234
91677169|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0662|TWO_SIDED|95.0|0.94|6.53|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 1|||6.53|0.94|0.0662
91677170|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.2767|TWO_SIDED|95.0|0.61|5.48|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.48|0.61|0.2767
91692363|NCT01436370|183279664|SUPERIORITY_OR_OTHER|||||||0.317|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.317
91526746|NCT02395133|182928900|SUPERIORITY||Percent Change Difference|-21.61|||<|0.0001|TWO_SIDED|95.0|-28.36|-14.87|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-14.87|-28.36|<0.0001
91677171|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17||||0.0588|TWO_SIDED|95.0|0.96|10.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||10.5|0.96|0.0588
91677172|NCT01000493|183248744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33||||0.1032|TWO_SIDED|95.0|0.78|14.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||14.1|0.78|0.1032
91677173|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.1743|TWO_SIDED|95.0|-0.29|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||0.05|-0.29|0.1743
91677174|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.1181|TWO_SIDED|95.0|-0.46|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||0.05|-0.46|0.1181
91677175|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.9698|TWO_SIDED|95.0|-0.35|0.34||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.34|-0.35|0.9698
91677176|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1341|TWO_SIDED|95.0|-0.69|0.09||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||0.09|-0.69|0.1341
91677177|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.0064|TWO_SIDED|95.0|-1.04|-0.18||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||-0.18|-1.04|0.0064
91677178|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.1095|TWO_SIDED|95.0|-0.98|0.1||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.10|-0.98|0.1095
91677179|NCT01000493|183248745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2814|TWO_SIDED|95.0|-0.9|0.27||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||0.27|-0.90|0.2814
91677180|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92||||0.0083|TWO_SIDED|95.0|-3.33|-0.5||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1|||-0.50|-3.33|0.0083
91677181|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94||||0.0311|TWO_SIDED|95.0|-3.71|-0.18||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||-0.18|-3.71|0.0311
91677182|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.1155|TWO_SIDED|95.0|-4.26|0.47||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.47|-4.26|0.1155
91677183|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.89||||0.021|TWO_SIDED|95.0|-5.33|-0.45||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||-0.45|-5.33|0.0210
91677184|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0582|TWO_SIDED|95.0|-5.83|0.1||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||0.10|-5.83|0.0582
91677185|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88||||0.0927|TWO_SIDED|95.0|-6.25|0.49||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.49|-6.25|0.0927
91677186|NCT01000493|183248752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.8954|TWO_SIDED|95.0|-4.36|3.83||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.83|-4.36|0.8954
91692364|NCT01436370|183279664|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.564
91692365|NCT01436370|183279664|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.999
91486735|NCT02718300|182846300|SUPERIORITY||GMR|0.627|||||TWO_SIDED|95.0|0.397|0.99|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.990|0.397|
91486736|NCT02718300|182846301|SUPERIORITY|||||||0.0756|||||||Kruskal-Wallis|||Day 1||||0.0756
91486737|NCT02718300|182846301|SUPERIORITY|||||||0.0866|||||||Kruskal-Wallis|||Week 4||||0.0866
91677187|NCT03629028|183248759|NON_INFERIORITY|Data compared to meta-analysis conducted in Sardo et al., 2017||||||0.05|||||||Chi-squared|Chi-squared or Fisher's test statistic was used to compare the categorical variables.||The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group.||||0.05
91677188|NCT02192164|183248774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.757334|STANDARD_ERROR_OF_MEAN|1.594019|||TWO_SIDED|95.0|-5.916307|0.401638||||||||0.401638|-5.916307|
91677189|NCT02192164|183248775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.911449|STANDARD_ERROR_OF_MEAN|1.426517|||TWO_SIDED|95.0|-3.73847|1.915572||||||||1.915572|-3.73847|
91677190|NCT03123861|183248781|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91677191|NCT03123861|183248782|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91677192|NCT03123861|183248783|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91677193|NCT03123861|183248784|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91677194|NCT05011123|183248787|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-3.4|1.8|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||1.8|-3.4|
91677195|NCT05011123|183248788|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-5%|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.0|3.0|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.0|-4.0|
91677196|NCT00461253|183248800|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.12|0.88|
91677197|NCT00461253|183248800|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.93|1.17|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.17|0.93|
91677198|NCT00461253|183248800|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.52|1.39|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.39|0.52|
91677199|NCT00461253|183248800|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.58|1.41|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.41|0.58|
91692366|NCT01436370|183279664|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.564
91486738|NCT02718300|182846302|SUPERIORITY|||||||0.4287|||||||ANOVA|||Day 1||||0.4287
91486739|NCT02718300|182846302|SUPERIORITY||GMR|1.272|||||TWO_SIDED|95.0|0.329|4.914|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.914|0.329|
91486740|NCT02718300|182846302|SUPERIORITY||GMR|1.036|||||TWO_SIDED|95.0|0.252|4.251|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.251|0.252|
91677200|NCT02297438|183248802|SUPERIORITY||Hazard Ratio (HR)|0.677||||0.0012|TWO_SIDED|95.0|0.529|0.867||1-sided p-value from the adjusted log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral vs. non-visceral) per Randomization.||0.867|0.529|0.0012
91527556|NCT04249336|182930406|SUPERIORITY||Mean Difference (Net)|28.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
91677201|NCT02297438|183248803|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.14778|TWO_SIDED|95.0|0.651|1.139||1-sided p-value from the log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.139|0.651|0.14778
91677202|NCT02297438|183248804|SUPERIORITY||Odds Ratio (OR)|1.301||||0.154|TWO_SIDED|95.0|0.805|2.1||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.100|0.805|0.154
91677203|NCT02297438|183248805|SUPERIORITY||Odds Ratio (OR)|1.255||||0.206|TWO_SIDED|95.0|0.762|2.066||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.066|0.762|0.206
91677204|NCT02297438|183248806|SUPERIORITY||Odds Ratio (OR)|1.315||||0.135|TWO_SIDED|95.0|0.825|2.095||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.095|0.825|0.135
91677205|NCT02297438|183248807|SUPERIORITY||Odds Ratio (OR)|1.392||||0.117|TWO_SIDED|95.0|0.825|2.346||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.346|0.825|0.117
91677206|NCT02297438|183248810|SUPERIORITY||Odds Ratio (OR)|0.945||||0.471|TWO_SIDED|95.0|0.533|1.673||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.673|0.533|0.471
91677207|NCT02297438|183248811|SUPERIORITY||Odds Ratio (OR)|0.878||||0.383|TWO_SIDED|95.0|0.474|1.621||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.621|0.474|0.383
91677208|NCT02297438|183248812|SUPERIORITY||Odds Ratio (OR)|1.227||||0.248|TWO_SIDED|95.0|0.725|2.082||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.082|0.725|0.248
91677209|NCT02297438|183248813|SUPERIORITY||Odds Ratio (OR)|1.349||||0.189|TWO_SIDED|95.0|0.731|2.509||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.509|0.731|0.189
91677210|NCT02297438|183248814|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.36502|TWO_SIDED|95.0|0.698|1.286||1-sided p-value was from exact test.|Log Rank||Assuming Cox proportional hazards, hazard ratio less than 1 indicates reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.286|0.698|0.36502
91677211|NCT02297438|183248821|SUPERIORITY||Mean|0.031||||0.1914|TWO_SIDED|95.0|-0.02|0.08|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.08|-0.02|0.1914
91677212|NCT02297438|183248822|SUPERIORITY||Mean|3.358||||0.0078|TWO_SIDED|95.0|0.88|5.83|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||5.83|0.88|0.0078
91677213|NCT02297438|183248823|SUPERIORITY||Mean|0.476||||0.7862|TWO_SIDED|95.0|-2.97|3.92|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.92|-2.97|0.7862
91677214|NCT02440022|183248838|SUPERIORITY|||||||0.0562|||||||Kaplan-Meier|||||||0.0562
91677215|NCT02440022|183248839|NON_INFERIORITY|Where δ = 10% is the non-inferiority margin, which is the range of difference that is considered not clinically important. A non-inferiority Farrington and Manning Test was used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. In addition to the p-value of the test, the confidence intervals of the rate in each group and the difference between the two groups is calculated.||||||0.002|||||||Binary Analysis|||"H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 \> p2 - δ)"||||0.002
91677216|NCT02440022|183248845|OTHER|||||||0.716||||||P-value was type 3 test of the interaction of treatment group and pre-dilation balloon type.|Regression, Cox|||||||0.7160
91677217|NCT02358343|183248860|SUPERIORITY|||||||0.77||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood ratio test obtained from logistic regression analysis adjusting for site||||||0.77
91677218|NCT02358343|183248861|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.035|TWO_SIDED|95.0|-3.54|-0.13||a priori threshold for significance is 0.05.|Wald Test|The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.|The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT).|All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.||-0.13|-3.54|0.035
91486741|NCT02718300|182846302|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.18|2.731|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.731|0.180|
91486742|NCT02718300|182846302|SUPERIORITY||GMR|0.525|||||TWO_SIDED|95.0|0.118|2.348|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.348|0.118|
91486743|NCT02718300|182846302|SUPERIORITY|||||||0.9788|||||||ANOVA|||Week 4||||0.9788
91486744|NCT02718300|182846302|SUPERIORITY||GMR|0.879|||||TWO_SIDED|95.0|0.198|3.896|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.896|0.198|
91486745|NCT02718300|182846302|SUPERIORITY||GMR|1.225|||||TWO_SIDED|95.0|0.27|5.56|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||5.560|0.270|
91486746|NCT02718300|182846302|SUPERIORITY||GMR|0.918|||||TWO_SIDED|95.0|0.221|3.821|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.821|0.221|
91486747|NCT02718300|182846302|SUPERIORITY||GMR|0.853|||||TWO_SIDED|95.0|0.169|4.299|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||4.299|0.169|
91486748|NCT02718300|182846303|SUPERIORITY|||||||0.1208|||||||ANOVA|||Day 1||||0.1208
91526747|NCT02395133|182928901|SUPERIORITY||Percentage difference|24.5|||=|0.004|TWO_SIDED|95.0|9.7|39.29||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||39.29|9.70|= 0.0040
91677219|NCT02358343|183248862|SUPERIORITY|||||||0.96||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood Ratio Test from logistic regression analysis adjusting for clinical site.||||||0.96
91677220|NCT02358343|183248863|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-7.4|-0.02|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.02|-7.4|
91677221|NCT02358343|183248864|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.1|0.8|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.8|-3.1|
91677222|NCT02358343|183248865|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-6.2|-0.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.1|-6.2|
91677223|NCT02358343|183248866|SUPERIORITY||Mean Difference (Final Values)|10.2|||||TWO_SIDED|95.0|1.3|19.0|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||19.0|1.3|
91677224|NCT02358343|183248867|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.2|1.4|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||1.4|-0.2|
91677225|NCT02358343|183248868|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|0.1|5.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||5.1|0.1|
91677226|NCT02358343|183248869|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.5|0.5|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.5|-0.5|
91677227|NCT02358343|183248871|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.5|0.7|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.7|-0.5|
91677228|NCT02358343|183248872|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.55|1.1|||||The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator).|||1.10|0.55|
91677229|NCT02358343|183248873|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.54|0.34|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.34|-0.54|
91677230|NCT02358343|183248874|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.25|0.75|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.75|-0.25|
91677231|NCT00792935|183248894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|4.4||0.847|TWO_SIDED|95.0|-7.9|9.6|||Constrained longitudinal analysis|||Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.||9.6|-7.9|0.847
91677232|NCT00792935|183248895|SUPERIORITY_OR_OTHER||Proportions|-7.7||||0.361|TWO_SIDED|95.0|-23.6|8.7|||Miettinen & Nurminen method.||The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.|||8.7|-23.6|0.361
91677233|NCT00368979|183248965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.003||95.0|-2.7|-0.5|||ANCOVA|||||-0.5|-2.7|0.003
91677234|NCT00912093|183248973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
91677235|NCT00912093|183248974|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
91677236|NCT00912093|183248975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Peto Peto Wilcoxon|||||||0.012
91677237|NCT00912093|183248976|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
91677238|NCT00912093|183248977|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
91486749|NCT02718300|182846303|SUPERIORITY||GMR|1.251|||||TWO_SIDED|95.0|0.832|1.879|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.879|0.832|
91677239|NCT01462318|183248982|SUPERIORITY_OR_OTHER||ratio|1.015|||||TWO_SIDED|90.0|0.894|1.153|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.153|0.894|
91677240|NCT01462318|183248982|SUPERIORITY_OR_OTHER||ratio|1.005|||||TWO_SIDED|90.0|0.951|1.063|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.063|0.951|
91677241|NCT01462318|183248982|SUPERIORITY_OR_OTHER||ratio|0.996|||||TWO_SIDED|90.0|0.88|1.127|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.127|0.880|
91677242|NCT01462318|183248982|SUPERIORITY_OR_OTHER||ratio|1.032|||||TWO_SIDED|90.0|0.93|1.145|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of maximum observed concentration \[Cmax\]).||1.145|0.930|
91677243|NCT01462318|183248983|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.764|1.342|||||test/reference = dextromethorphan+DAC HYP/dextromethorphan|Pairwise comparison: dextromethorphan. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.342|0.764|
91677244|NCT01462318|183248991|SUPERIORITY_OR_OTHER||ratio|1.079|||||TWO_SIDED|90.0|0.912|1.276|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.276|0.912|
91677245|NCT01462318|183248991|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.952|1.075|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.075|0.952|
91677246|NCT01462318|183248991|SUPERIORITY_OR_OTHER||ratio|1.058|||||TWO_SIDED|90.0|0.804|1.392|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.392|0.804|
91677247|NCT01462318|183248991|SUPERIORITY_OR_OTHER||ratio|1.116|||||TWO_SIDED|90.0|1.005|1.238|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of Cmax).||1.238|1.005|
91677248|NCT01462318|183248993|SUPERIORITY_OR_OTHER||ratio|0.878|||||TWO_SIDED|90.0|0.697|1.105|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.105|0.697|
91677249|NCT00270257|183248994|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|1.5|||||TWO_SIDED|95.0|0.7|2.8||||||||2.8|0.7|
91677250|NCT00270257|183248994|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|2.2|||||TWO_SIDED|95.0|1.2|3.7||||||||3.7|1.2|
91677251|NCT00270257|183248994|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.694||||0.3769|TWO_SIDED|95.0|0.308|1.562|||Regression, Cox|||||1.562|0.308|0.3769
91677252|NCT00270257|183248995|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.844||||0.4325|TWO_SIDED|95.0|0.553|1.289||P value applies for the comparison at visit 104.|Regression, Logistic|adjusted for site||||1.289|0.553|0.4325
91486750|NCT02718300|182846303|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.649|1.518|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.518|0.649|
91677253|NCT00270257|183248996|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.2749|TWO_SIDED|95.0|0.536|1.194||P value applies for the comparison at visit 104 only.|Regression, Logistic|||||1.194|0.536|0.2749
91677254|NCT00270257|183248997|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.746||||0.3446|TWO_SIDED|95.0|0.407|1.369||Analysis is done for visit 104|Regression, Logistic|Adjusted for site||||1.369|0.407|0.3446
91677255|NCT00270257|183248998|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8712||||0.362|TWO_SIDED|95.0|0.6477|1.1718||P value applies for the comparison at visit 104 only. See the estimation comments for the other visits|Generalized linear model|adjusted for site.||||1.1718|0.6477|0.3620
91677256|NCT00270257|183248999|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|22.0|||||TWO_SIDED|95.0|14.7|31.6|||||29 events over 132 person-years|||31.6|14.7|
91677257|NCT00270257|183248999|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|4.59|||||TWO_SIDED|95.0|2.0|9.0|||||8 events over 174 person-years|||9.0|2.0|
91677258|NCT00270257|183249000|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|2.7|||||TWO_SIDED|95.0|1.22|5.08|||||9 events over 336 person-years|||5.08|1.22|
91677259|NCT00270257|183249000|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|0.0|||||TWO_SIDED|95.0|0.0|10.1|||||0 events over 37 person-years|||10.1|0.00|
91677260|NCT01155024|183249018|NON_INFERIORITY_OR_EQUIVALENCE|10 participants required to detect one value change in rating for the SCS scale, with 80% power.|||||>|0.4||95.0||||Two-Sided|t-test, 2 sided|||Alpha level of 0.05||||>0.4
91677261|NCT00302081|183249061|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.02||||0.041||95.0|-0.1|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks)\]-\[PEG2b 1.5/R(24 weeks)\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 1.5-dose group and 0.643 (144/224 subjects) in the 1.0-dose group, for a risk difference of -0.02.||This is an evaluation of the effect of the peginterferon alfa-2b dose (1.0 vs 1.5 micrograms/kg/week) on the primary outcome measure.||1|-0.10|0.041
91486751|NCT02718300|182846303|SUPERIORITY||GMR|0.967|||||TWO_SIDED|95.0|0.645|1.45|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.450|0.645|
91486752|NCT02718300|182846303|SUPERIORITY||GMR|0.86|||||TWO_SIDED|95.0|0.548|1.35|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.350|0.548|
91486753|NCT02718300|182846303|SUPERIORITY|||||||0.3218|||||||ANOVA|||Week 4||||0.3218
91677262|NCT00302081|183249061|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.1||||0.495||95.0|-0.17|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks\]-\[PEG2b 1.5/R(24 weeks\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 24-week group and 0.566 (129/228 subjects) in the 16-week group, for a risk difference of -0.10.||This is an evaluation of the effect of treatment duration (24 weeks vs 16 weeks) on the primary outcome measure.||1|-0.17|0.495
91486754|NCT02718300|182846303|SUPERIORITY||GMR|0.761|||||TWO_SIDED|95.0|0.482|1.2|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.200|0.482|
91486755|NCT02718300|182846303|SUPERIORITY||GMR|0.803|||||TWO_SIDED|95.0|0.506|1.277|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.277|0.506|
91677263|NCT02701413|183249063|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91677264|NCT02701413|183249067|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91677265|NCT00535587|183249072|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.94|<|0.02|TWO_SIDED|95.0|||||ANCOVA|||||||<0.02
91677266|NCT00536263|183249076|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.008||||0.86|TWO_SIDED|95.0|-0.063|0.079||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.079|-0.063|0.860
91677267|NCT00536263|183249076|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.061|0.217||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.217|0.061|<0.001
91677268|NCT00536263|183249076|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of PEG 1.5 mcg/kg\*24 weeks with respect to PEG 1.5 mcg/kg\*48 weeks was to be concluded if the lower bound of the one-sided 95% confidence interval of the difference of the rates (PEG 1.5 mcg/kg\*24 weeks minus PEG 1.5 mcg/kg\*48 weeks) was greater than the noninferiority margin of -10%.|Pairwise rate difference|-0.132|||||TWO_SIDED|90.0|-0.198|-0.065||||||||-0.065|-0.198|
91677269|NCT00536263|183249077|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.011||||0.7|TWO_SIDED|95.0|-0.074|0.052|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.052|-0.074|0.700
91486756|NCT02718300|182846303|SUPERIORITY||GMR|0.667|||||TWO_SIDED|95.0|0.432|1.028|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.028|0.432|
91486757|NCT02718300|182846303|SUPERIORITY||GMR|0.64|||||TWO_SIDED|95.0|0.39|1.051|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.051|0.390|
91486758|NCT04063384|182846310|OTHER||||||<|0.05||||||The p-value was not adjusted for multiple comparisons.|Mixed Models Analysis||||Group (bipolar, healthy)-by-condition (alcohol, placebo)-by-time of subjective response interactions on subjective response to alcohol were modeled, covarying beverage condition order, biological sex, and age, with SEAS and DEQ subscale scores as the dependent variables. Time of subjective response (pre- and post-scan) and beverage condition (alcohol, placebo) were within-subject factors and group was an independent between-subject factor.|||<0.05
91486759|NCT04063384|182846311|OTHER||||||<|0.004||||||Results of primary models were considered significant at p ≤ 0.004 (Bonferroni correction for twelve ROI-to-ROI connections).|Mixed Models Analysis|||Power analysis suggests this sample size (n = 23 with bipolar disorder, n = 24 healthy comparison participants), at an alpha = 0.05, provides \> 80% statistical power to detect a within subject effect size (ES) d ≥ 0.6 in both subgroups and a between group ES d ≥ 0.8 in this fMRI analysis.|We used a mixed model to examine group by condition by hemisphere (left, right) interactions on ROI-to-ROI FC response to emotional stimuli (contrast: emotional stimuli - squares). Group was an independent between-subject factor, condition and hemisphere were within-subject factors, and ROI-to-ROI FC was the dependent variable.|||<0.004
91486760|NCT03894046|182846316|NON_INFERIORITY|"Non-inferiority was concluded if the upper limit of the 2-sided 95% CI was less than +20%.~Superiority was concluded if the upper limit of the 2-sided 95% CI was less than 0."|Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-30.0|3.5||||||The non-inferiority assessment was based on the 2-sided 95% CIs computed using a continuity-corrected Z-statistic for the difference (\[sulbactam-durlobactam + imipenem/cilastatin\] - \[colistin + imipenem/cilastatin\]) in 28-day all-cause mortality rates between the treatment groups.||3.5|-30|
91527557|NCT04249336|182930406|SUPERIORITY||Mean Difference (Net)|25.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
91677270|NCT00536263|183249077|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.125|TWO_SIDED|95.0|-0.014|0.123|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.123|-0.014|0.125
91677271|NCT00536263|183249077|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.065|||||TWO_SIDED|90.0|-0.122|-0.008||||||||-0.008|-0.122|
91677272|NCT00536263|183249078|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.016||||0.598|TWO_SIDED|95.0|-0.078|0.047|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.047|-0.078|0.598
91677273|NCT00536263|183249078|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.041||||0.24|TWO_SIDED|95.0|-0.027|0.108|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.108|-0.027|0.24
91486761|NCT03894046|182846317|OTHER|||||||0.0002||||||p-value was obtained based on a Chi-Square test for treatment group differences.|Chi-squared|||Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline baseline.||||0.0002
91677274|NCT00536263|183249078|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.056|||||TWO_SIDED|90.0|-0.112|-0.001||||||End of treatment||-0.001|-0.112|
91677275|NCT00536263|183249078|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.006||||0.83|TWO_SIDED|95.0|-0.075|0.063|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.063|-0.075|0.830
91677276|NCT00536263|183249078|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.13||||0.001|TWO_SIDED|95.0|0.053|0.208|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.208|0.053|0.001
91677277|NCT00536263|183249078|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.136||||||90.0|-0.201|-0.071||||||24 weeks after EOT||-0.071|-0.201|
91677278|NCT00536263|183249079|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.072||||0.076|TWO_SIDED|95.0|-0.007|0.151|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.151|-0.007|0.076
91677279|NCT00536263|183249079|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.135||||0.001|TWO_SIDED|95.0|0.053|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.053|0.001
91677280|NCT00536263|183249079|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.063|||||TWO_SIDED|90.0|-0.135|0.009||||||End of treatment||0.009|-0.135|
91677281|NCT00536263|183249079|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.017||||0.662|TWO_SIDED|95.0|-0.058|0.092|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.092|-0.058|0.662
91677282|NCT00536263|183249079|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.059|0.22|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.220|0.059|<0.001
91486762|NCT03270644|182846318|OTHER||Difference of LSMeans|-5.45|||||TWO_SIDED|90.0|-7.27|-3.64||||||Mean hourly HR was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-3.64|-7.27|
91486763|NCT03270644|182846319|OTHER||Ratio of Geometric LSMeans|0.884|||||TWO_SIDED|90.0|0.832|0.939||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||0.939|0.832|
91486764|NCT03270644|182846320|OTHER||Ratio of Geometric LSMeans|0.958|||||TWO_SIDED|90.0|0.917|1.0||||||Ratio of geometric LSMeans of Cmax used a mixed-effects repeated measures model adjusted for fixed effects for treatment, time point, time point by treatment, and random effect for subjects.||1.00|0.917|
91677283|NCT00536263|183249079|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.122|||||TWO_SIDED|90.0|-0.191|-0.053||||||24 weeks after EOT||-0.053|-0.191|
91677284|NCT00536263|183249080|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.019||||0.373|TWO_SIDED|95.0|-0.023|0.061|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.061|-0.023|0.373
91677285|NCT00536263|183249080|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.049||||0.04|TWO_SIDED|95.0|0.003|0.096|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.096|0.003|0.040
91677286|NCT00536263|183249080|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.03|||||TWO_SIDED|90.0|-0.072|0.011||||||End of treatment||0.011|-0.072|
91677287|NCT00536263|183249080|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.969|TWO_SIDED|95.0|-0.041|0.043|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.043|-0.041|0.969
91677288|NCT00536263|183249080|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.045||||0.074|TWO_SIDED|95.0|-0.004|0.094|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.094|-0.004|0.074
91677289|NCT00536263|183249080|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.044|||||TWO_SIDED|90.0|-0.085|-0.003||||||24 weeks after EOT||-0.003|-0.085|
91677290|NCT00536263|183249081|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.019|-0.027|0.724
91677291|NCT00536263|183249081|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.243|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.048|-0.012|0.243
91677292|NCT00536263|183249081|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||End of treatment||0.002|-0.046|
91677293|NCT00536263|183249081|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.019|-0.027|0.724
91677294|NCT00536263|183249081|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.232|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.048|-0.012|0.232
91677295|NCT00536263|183249081|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||24 weeks after EOT||0.002|-0.046|
91677296|NCT00536263|183249082|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.056||||0.219|TWO_SIDED|95.0|-0.033|0.145|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.145|-0.033|0.219
91677297|NCT00536263|183249082|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.126||||0.006|TWO_SIDED|95.0|0.037|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.037|0.006
91677298|NCT00536263|183249082|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.071|||||TWO_SIDED|90.0|-0.148|0.006||||||End of treatment||0.006|-0.148|
91677299|NCT00536263|183249082|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.082||||0.067|TWO_SIDED|95.0|-0.004|0.168|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.168|-0.004|0.067
91677300|NCT00536263|183249082|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.18|||<|0.001|TWO_SIDED|95.0|0.092|0.268|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.268|0.092|<0.001
91677301|NCT00536263|183249082|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.098|||||TWO_SIDED|90.0|-0.174|-0.021||||||24 weeks after EOT||-0.021|-0.174|
91677302|NCT00536263|183249083|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.995|TWO_SIDED|95.0|-0.039|0.041|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.041|-0.039|0.995
91677303|NCT00536263|183249083|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.031|TWO_SIDED|95.0|0.005|0.103|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.103|0.005|0.031
91677304|NCT00536263|183249083|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.053|||||TWO_SIDED|90.0|-0.094|-0.012||||||End of treatment||-0.012|-0.094|
91486765|NCT03270644|182846321|OTHER||Ratio of Geometric LSMeans|1.01|||||TWO_SIDED|90.0|0.967|1.04||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.04|0.967|
91677305|NCT00536263|183249083|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.024||||0.389|TWO_SIDED|95.0|-0.03|0.078|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.078|-0.030|0.389
91677306|NCT00536263|183249083|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.121|||<|0.001|TWO_SIDED|95.0|0.058|0.184|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.184|0.058|<0.001
91677307|NCT00536263|183249083|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.097|||||TWO_SIDED|90.0|-0.152|-0.041||||||24 weeks after EOT||-0.041|-0.152|
91677308|NCT00536263|183249084|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.991|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.012|-0.012|0.991
91677309|NCT00536263|183249084|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.181|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.033|-0.006|0.181
91677310|NCT00536263|183249084|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||End of treatment||0.003|-0.030|
91677311|NCT00536263|183249084|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.971|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.012|-0.012|0.971
91677312|NCT00536263|183249084|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.179|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.033|-0.006|0.179
91677313|NCT00536263|183249084|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||24 weeks after EOT||0.003|-0.030|
91677314|NCT00536263|183249085|SUPERIORITY_OR_OTHER|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||End of treatment||||0.991
91677315|NCT00536263|183249085|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.004||||0.322|TWO_SIDED|95.0|-0.004|0.013|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.013|-0.004|0.322
91677316|NCT00536263|183249085|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004|||||TWO_SIDED|90.0|-0.012|0.003||||||End of treatment||0.003|-0.012|
91677317|NCT00536263|183249085|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||24 weeks after EOT||||0.991
91486766|NCT03270644|182846322|OTHER||Ratio of Geometric LSMeans|0.999|||||TWO_SIDED|90.0|0.967|1.03||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.03|0.967|
91486767|NCT03270644|182846323|OTHER||Difference of LSMeans|-3.51|||||TWO_SIDED|90.0|-6.39|-0.64||||||PR interval was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-0.64|-6.39|
91677318|NCT00536263|183249085|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.009||||0.157|TWO_SIDED|95.0|-0.003|0.021|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.021|-0.003|0.157
91677319|NCT00536263|183249085|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.009|||||TWO_SIDED|90.0|-0.019|0.001||||||24 weeks after EOT||0.001|-0.019|
91677320|NCT00536263|183249086|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.014
91677321|NCT00536263|183249086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||<0.001
91677322|NCT00536263|183249086|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.010
91677323|NCT00536263|183249086|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.2|0.631
91677324|NCT00536263|183249086|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.3||||0.617|TWO_SIDED|95.0|-1.4|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.4|0.617
91677325|NCT00536263|183249086|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||||1.1|-1.1|
91677326|NCT01640873|183249131|OTHER||Least Squares Mean Difference|-8.5||||0.356|TWO_SIDED|90.0|-47.4|30.4||The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met.|Constrained longitudinal data analysis|||||30.4|-47.4|0.356
91677327|NCT01640873|183249133|OTHER||Geometric Mean Ratio|1.05||||0.2714|TWO_SIDED|90.0|0.92|1.19||The posterior probability that the reduction in 24h-WMG is ≥ 20 mg/dL is \< 0.01, and hence, the 24h- WMG hypothesis was not met.|Constrained longitudinal data analysis|||||1.19|0.92|0.2714
91677328|NCT01640873|183249134|OTHER|Day 1|Geometric Mean Ratio|1.22||||0.06|TWO_SIDED|95.0|0.99|1.55|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.55|0.99|0.060
91677329|NCT01640873|183249134|OTHER|Day 3|Geometric mean Ratio|1.2||||0.065|TWO_SIDED|95.0|0.98|1.47|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.47|0.98|0.065
91677330|NCT01640873|183249134|OTHER|Day 16|Geometric Mean Ratio|1.1||||0.217|TWO_SIDED|95.0|0.89|1.37|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.37|0.89|0.217
91677331|NCT00534794|183249143|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|||ITT (Intent to Treat)||||0.532
91677332|NCT00534794|183249144|SUPERIORITY_OR_OTHER|||||||0.927||95.0|||||Student's t-test|||ITT (Intent to Treat)||||0.927
91677333|NCT03431974|183249145|SUPERIORITY|||||||0.43|||||||Fisher Exact|||The efficacy of LD-AMT established using a step-down analysis approach with one-sided Fisher's exact tests. First, the analysis for subjects attaining PASI 75 will be performed, then, if that analysis shows a significant treatment effect, analysis for subjects attaining a sPGA success will be performed.||||0.43
91677334|NCT01301508|183249153|SUPERIORITY_OR_OTHER|||||||0.008||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.|Two-sided sign test|||||||0.008
91677335|NCT01301508|183249153|SUPERIORITY_OR_OTHER|||||||0.017||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.|Two-sided sign test|||||||0.017
91677336|NCT01929031|183249167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.738|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|33.767|49.708|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||49.708|33.767|<0.0001
91486768|NCT03270644|182846324|OTHER||Difference of LSMeans|5.57|||||TWO_SIDED|90.0|3.57|7.57||||||Systolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||7.57|3.57|
91486769|NCT03270644|182846325|OTHER||Difference of LSMeans|3.47|||||TWO_SIDED|90.0|1.99|4.95||||||Diastolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||4.95|1.99|
91486770|NCT02476201|182846326|SUPERIORITY|Using a one-sided, one sample Exact Binomial Test and a significance level of 2.5%, the study required 74 patients to reach a power of 90%. With the MPP feature activated at baseline, it was assumed that the proportion of responders at 6 months was 75%. The MPP responder rate was compared to 57%, which is the responder rate obtained from literature for patients without the MPP feature activated.|Percentage|67.1||||0.0435|ONE_SIDED|97.5|55.6||||Exact binomial||||||55.6|0.0435
91486771|NCT00333801|182846331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91486772|NCT00333801|182846332|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91486773|NCT00333801|182846333|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d|0.93|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91486774|NCT00777205|182846338|SUPERIORITY_OR_OTHER||Slope|0.22|||<|0.05|TWO_SIDED|95.0|-1.57|2.01|||Mixed Models Analysis|||||2.01|-1.57|<0.05
91677337|NCT01929031|183249167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.467|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|28.497|44.437|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||44.437|28.497|<0.0001
91677338|NCT01929031|183249167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.126|STANDARD_ERROR_OF_MEAN|2.868|<|0.0001|TWO_SIDED|95.0|6.493|17.759|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||17.759|6.493|<0.0001
91677339|NCT01929031|183249168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.525|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.937|10.113|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||10.113|6.937|<0.0001
91677340|NCT01929031|183249168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.972|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.384|9.559|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||9.559|6.384|<0.0001
91677341|NCT01929031|183249168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.594|STANDARD_ERROR_OF_MEAN|0.571|<|0.0001|TWO_SIDED|95.0|2.472|4.716|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||4.716|2.472|<0.0001
91677342|NCT01929031|183249169|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
91677343|NCT01929031|183249169|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
91677344|NCT01929031|183249169|SUPERIORITY_OR_OTHER|||||||0.2389|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.2389
91677345|NCT01929031|183249170|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
91677346|NCT01929031|183249170|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
91677347|NCT01929031|183249170|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.0001
91677348|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Sensitivity|0.85|||||TWO_SIDED|95.0|0.79|0.89|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||0.89|0.79|
91677349|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Specificity|0.98|||||TWO_SIDED|95.0|0.93|0.99|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.99|0.93|
91486775|NCT00777205|182846339|SUPERIORITY_OR_OTHER||Slope|-0.39|||<|0.05|TWO_SIDED|95.0|-2.03|1.24|||Mixed Models Analysis|||||1.24|-2.03|<0.05
91677350|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.99|||||TWO_SIDED|95.0|0.96|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||1.00|0.96|
91677351|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.77|||||TWO_SIDED|95.0|0.69|0.84|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||0.84|0.69|
91677352|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Sensitivity|0.99|||||TWO_SIDED|95.0|0.97|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||1.00|0.97|
91677353|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Specificity|0.91|||||TWO_SIDED|95.0|0.83|0.95|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.95|0.83|
91677354|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.95|||||TWO_SIDED|95.0|0.9|0.98|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||0.98|0.90|
91486776|NCT00777205|182846340|SUPERIORITY_OR_OTHER||Slope|0.81|||<|0.05|TWO_SIDED|95.0|-0.93|2.55|||Mixed Models Analysis|||||2.55|-0.93|<0.05
91677355|NCT01366443|183249171|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.99|||||TWO_SIDED|95.0|0.94|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||1.00|0.94|
91677356|NCT00321594|183249172|OTHER||Maximum Tolerated Dose|1400.0|||||TWO_SIDED||||||||MTD was not reached and the maximum dose of 1400 mg/m2 is used in Phase II portion|MTD is defined as the dose below which \>=2 of 3 or \>= 2 of 6 patients experience DLT||||
91677357|NCT00369382|183249174|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||two-sided alpha = 0.05|ANCOVA|Analysis of covariance (ANCOVA) with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.004
91677358|NCT00369382|183249176|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.018
91486777|NCT00777205|182846341|SUPERIORITY_OR_OTHER||Slope|-0.039|||<|0.05|TWO_SIDED|95.0|-2.66|1.89|||Mixed Models Analysis|||||1.89|-2.66|<0.05
91486778|NCT00777205|182846342|SUPERIORITY_OR_OTHER||Slope|-0.08|||||TWO_SIDED|95.0|-3.31|3.16||||||||3.16|-3.31|
91486779|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|-10.59|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
91486780|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|2.18|STANDARD_ERROR_OF_MEAN|2.42||0.1858|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.1858
91486781|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|8.66|STANDARD_ERROR_OF_MEAN|2.55||0.0007|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0007
91486782|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|14.45|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
91486783|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|-14.14|STANDARD_ERROR_OF_MEAN|4.55|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
91677359|NCT00369382|183249176|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<.001
91677360|NCT00369382|183249176|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.012
91677361|NCT00369382|183249176|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.072
91677362|NCT00369382|183249176|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.175
91677363|NCT00369382|183249177|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.031
91677364|NCT00369382|183249177|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
91677365|NCT00369382|183249177|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.020
91677366|NCT00369382|183249177|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.151
91677367|NCT00369382|183249177|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.295
91677368|NCT00369382|183249177|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.010
91677369|NCT00369382|183249179|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.009
91677370|NCT00369382|183249179|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
91677371|NCT00369382|183249179|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.002
91677372|NCT00369382|183249179|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.030
91677373|NCT00369382|183249179|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.121
91677374|NCT00369382|183249179|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.001
91677375|NCT00369382|183249181|SUPERIORITY_OR_OTHER||slope difference (CNI - SRL)|-2.311||||0.126|TWO_SIDED|95.0|-5.282|0.66||alpha is unadjusted|Random coefficient model||Random coefficient model with each participant's creatinine clearance function of time on treatment; intra-subject regression coefficients considered random.|||0.660|-5.282|0.126
91677376|NCT00369382|183249183|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||For-cause Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.206
91677377|NCT00369382|183249183|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||Standard of Care Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.476
91677378|NCT01565616|183249195|OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|10.4||0.52|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the anxiety domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.52
91677379|NCT01565616|183249195|OTHER||Mean Difference (Net)|2.7|STANDARD_DEVIATION|6.4||0.12|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the depression domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.12
91486784|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|1.91|STANDARD_ERROR_OF_MEAN|4.56||0.3384|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3384
91486785|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|19.38|STANDARD_ERROR_OF_MEAN|3.94|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
91677380|NCT01565616|183249195|OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|8.5||0.54|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the fatigue domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.54
91677381|NCT01565616|183249195|OTHER||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|9.3||0.006|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the pain interference domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.006
91677382|NCT01565616|183249195|OTHER||Mean Difference (Net)|5.8|STANDARD_DEVIATION|10.5||0.044|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the physical function domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.044
91677383|NCT01565616|183249195|OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|11.8||0.85|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the satisfaction with social role domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.85
91677384|NCT01565616|183249195|OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|13.5||0.88|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the sleep disturbances domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.88
91677385|NCT01565616|183249195|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.1||0.53|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in raw scores of the pain intensity domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.53
91677386|NCT00986453|183249196|SUPERIORITY_OR_OTHER|||||||0.4697||95.0|||||t-test, 2 sided|||||||0.4697
91486786|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|38.37|STANDARD_ERROR_OF_MEAN|9.76||0.0002|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0002
91486787|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|-23.96|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
91486788|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|2.47|STANDARD_ERROR_OF_MEAN|5.4||0.3249|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3249
91486789|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|29.23|STANDARD_ERROR_OF_MEAN|6.53|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
91486790|NCT02633501|182846354|SUPERIORITY||Least Squares Mean|51.96|STANDARD_ERROR_OF_MEAN|10.68|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
91486791|NCT01104155|182846365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|||||||1-sided exact binomial|Based on a one-sided exact binomial test compared to 9%.||||||0.204
91486792|NCT01104155|182846365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||1-sided exact binomial|||||||0.041
91486793|NCT00464269|182846413|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|12.8|||=|0.025|TWO_SIDED|95.0|1.7|22.6|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.||22.6|1.7|=0.025
91527558|NCT01189890|182930408|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.4%.|Difference in LS Means|0.19|||||TWO_SIDED|95.0|0.03|0.34|||ANCOVA|Controlled for treatment, estimated glomerular filtration rate (eGFR) stratum, age stratum, and baseline HbA1C.||||0.34|0.03|
91677387|NCT00986453|183249197|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||t-test, 2 sided|||||||0.1470
91677388|NCT00986453|183249198|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
91677389|NCT00986453|183249199|SUPERIORITY_OR_OTHER|||||||0.0776||95.0|||||t-test, 2 sided|||||||0.0776
91677390|NCT00986453|183249200|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
91677391|NCT00922987|183249227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||||||<0.0001
91677392|NCT00586482|183249250|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||A two-sided p value of less than or equal to 0.05 was considered statistically significant.||||0.12
91677393|NCT00586482|183249251|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
91677394|NCT00586482|183249252|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
91677395|NCT00586482|183249253|SUPERIORITY_OR_OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
91677396|NCT00586482|183249254|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
91677397|NCT04221789|183249266|OTHER|differences in proportions|Risk Ratio (RR)|1.12||||0.049|TWO_SIDED|95.0|1.02|1.2||Statistical significance threshold p \<0.05|Chi-squared|||Ho no difference in treatment success between groups. The study was originally powered to detect a 15% difference between groups||1.20|1.02|0.049
91677398|NCT04221789|183249267|OTHER|comparison of proportions and relative risk with 95% CI|Risk Ratio (RR)|0.7|||<|0.043|TWO_SIDED|95.0|0.5|0.97||statistical significance if p value \<0.05|Chi-squared||intervention / control|Ho No difference between arms. 80% power to detect a 10% difference||0.97|0.50|<0.043
91677399|NCT04394351|183249269|SUPERIORITY||Odds Ratio (OR)|53.8|||<|0.0001|TWO_SIDED|95.0|7.37|392.82|||Cochran-Mantel-Haenszel|p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline weight group.|Odds ratio and corresponding Confidence Interval (CI) are based on CMH test stratified by baseline weight group.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||392.82|7.37|<0.0001
91677400|NCT04394351|183249269|SUPERIORITY||Odds Ratio (OR)|46.7|||<|0.0001|TWO_SIDED|95.0|5.47|399.54|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group.|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||399.54|5.47|<0.0001
91677401|NCT04394351|183249270|SUPERIORITY||Odds Ratio (OR)|178.0|||<|0.0001|TWO_SIDED|95.0|18.84|1682.4|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1682.4|18.84|<0.0001
91677402|NCT04394351|183249270|SUPERIORITY||Odds Ratio (OR)|55.3|||<|0.0001|TWO_SIDED|95.0|7.45|410.23||P-value is not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||410.23|7.45|<0.0001
91677403|NCT04394351|183249271|SUPERIORITY||LS mean difference|-107.07|||<|0.0001|TWO_SIDED|95.0|-139.249|-74.9|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-74.900|-139.249|<0.0001
91677404|NCT04394351|183249271|SUPERIORITY||LS mean difference|-98.92|||<|0.0001|TWO_SIDED|95.0|-132.463|-65.37||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-65.370|-132.463|<0.0001
91677405|NCT04394351|183249272|SUPERIORITY||LS mean difference|-0.902|||<|0.0001|TWO_SIDED|95.0|-1.0325|-0.7714|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7714|-1.0325|<0.0001
91677406|NCT04394351|183249272|SUPERIORITY||LS mean difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-0.917|-0.644||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6440|-0.9170|<0.0001
91526748|NCT02395133|182928901|SUPERIORITY||Percentage difference|28.0|||=|0.0004|TWO_SIDED|95.0|13.32|42.58||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||42.58|13.32|= 0.0004
91677407|NCT04394351|183249273|SUPERIORITY||LS mean difference|-0.883|||<|0.0001|TWO_SIDED|95.0|-1.0095|-0.7568|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7568|-1.0095|<0.0001
91677408|NCT04394351|183249273|SUPERIORITY||LS mean difference|-0.769|||<|0.0001|TWO_SIDED|95.0|-0.9013|-0.6362||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6362|-0.9013|<0.0001
91677409|NCT04394351|183249274|SUPERIORITY||Hodges-Lehmann estimator|-2.22|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.95|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9500|-2.4400|<0.0001
91677410|NCT04394351|183249274|SUPERIORITY||Hodges-Lehmann estimator|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.82||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.8200|-2.4500|<0.0001
91677411|NCT04394351|183249275|SUPERIORITY||Hodges-Lehmann estimator|-2.84|||<|0.0001|TWO_SIDED|95.0|-3.35|-1.96|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9600|-3.3500|<0.0001
91677412|NCT04394351|183249275|SUPERIORITY||Hodges-Lehmann estimator|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.31|-1.62||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.6200|-3.3100|<0.0001
91677413|NCT04394351|183249276|SUPERIORITY||LS mean difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.94|-2.63|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-2.63|-4.94|<0.0001
91692367|NCT01436370|183279664|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.999
91692368|NCT01436370|183279664|SUPERIORITY_OR_OTHER|||||||0.655|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.655
91486794|NCT00464269|182846413|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|4.1|||=|0.492|TWO_SIDED|95.0|-8.1|15.0|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.||15.0|-8.1|=0.492
91486795|NCT03467048|182846454|NON_INFERIORITY|Null hypothesis: McGrath Video Laryngoscopy is non-inferior to Macintosh direct laryngoscopy.|Odds Ratio (OR)|4.65|||<|0.01|TWO_SIDED|95.0|2.22|9.75|||t-test, 1 sided|||||9.75|2.22|<0.01
91486796|NCT03467048|182846455|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.3||||0.08|TWO_SIDED|0.975|0.04|2.28|||t-test, 1 sided|||||2.28|0.04|0.08
91526749|NCT02395133|182928901|SUPERIORITY||Percentage difference|41.2|||<|0.0001|TWO_SIDED|95.0|28.93|53.52||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||53.52|28.93|<0.0001
91677414|NCT04394351|183249276|SUPERIORITY||LS mean difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.59|-2.1||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-2.10|-4.59|<0.0001
91677415|NCT04394351|183249277|SUPERIORITY||LS mean difference|-0.1||||0.1526|TWO_SIDED|95.0|-0.244|0.038|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.038|-0.244|0.1526
91677416|NCT04394351|183249277|SUPERIORITY||LS mean difference|0.0||||0.9533|TWO_SIDED|95.0|-0.155|0.146||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.146|-0.155|0.9533
91677417|NCT04394351|183249278|SUPERIORITY||LS mean difference|1.45||||0.1507|TWO_SIDED|95.0|-0.527|3.422||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||3.422|-0.527|0.1507
91677418|NCT04394351|183249278|SUPERIORITY||LS mean difference|0.0||||0.9965|TWO_SIDED|95.0|-2.107|2.117||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||2.117|-2.107|0.9965
91677419|NCT04394351|183249279|SUPERIORITY||LS mean difference|-0.05||||0.2064|TWO_SIDED|95.0|-0.139|0.03||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.030|-0.139|0.2064
91677420|NCT04394351|183249279|SUPERIORITY||LS mean difference|0.02||||0.6361|TWO_SIDED|95.0|-0.069|0.112||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.112|-0.069|0.6361
91677421|NCT04394351|183249280|SUPERIORITY||LS mean difference|0.13||||0.2086|TWO_SIDED|95.0|-0.072|0.33||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.330|-0.072|0.2086
91677422|NCT04394351|183249280|SUPERIORITY||LS mean difference|0.1||||0.2975|TWO_SIDED|95.0|-0.088|0.286||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.286|-0.088|0.2975
91677423|NCT04394351|183249281|SUPERIORITY||LS mean difference|-1.8||||0.2085|TWO_SIDED|95.0|-4.615|1.007||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1.007|-4.615|0.2085
91677424|NCT04394351|183249281|SUPERIORITY||LS mean difference|-1.36||||0.3098|TWO_SIDED|95.0|-3.972|1.26||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||1.260|-3.972|0.3098
91692369|NCT01436370|183279665|SUPERIORITY_OR_OTHER|||||||0.18|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.||||0.180
91486797|NCT03467048|182846456|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.87||||0.41|TWO_SIDED|97.5|0.1|7.77|||t-test, 1 sided|||||7.77|0.1|0.41
91486798|NCT04308304|182846468|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
91486799|NCT04308304|182846468|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
91486800|NCT04308304|182846468|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
91486801|NCT04308304|182846468|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
91486802|NCT04308304|182846469|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
91677425|NCT04394351|183249282|SUPERIORITY||LS mean difference|0.07||||0.236|TWO_SIDED|95.0|-0.046|0.186||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.186|-0.046|0.2360
91677426|NCT04394351|183249282|SUPERIORITY||LS mean difference|0.07||||0.1939|TWO_SIDED|95.0|-0.037|0.181||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.181|-0.037|0.1939
91677427|NCT03653507|183249338|SUPERIORITY||Hazard Ratio (HR)|0.689||||0.0005|TWO_SIDED|95.0|0.552|0.86|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.860|0.552|0.0005
91677428|NCT03653507|183249339|SUPERIORITY||Hazard Ratio (HR)|0.763||||0.0047|TWO_SIDED|95.0|0.622|0.936|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.936|0.622|0.0047
91677429|NCT03653507|183249340|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.4654|TWO_SIDED|95.0|0.772|1.328|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.328|0.772|0.4654
91677430|NCT03653507|183249341|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.4478|TWO_SIDED|95.0|0.673|1.577|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.577|0.673|0.4478
91677431|NCT03653507|183249342|SUPERIORITY||Hazard Ratio (HR)|0.869||||0.167|TWO_SIDED|95.0|0.655|1.153|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.153|0.655|0.1670
91677432|NCT03653507|183249343|SUPERIORITY|||||||0.2219||||||Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.|Cochran-Mantel-Haenszel|||||||0.2219
91677433|NCT03653507|183249344|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0826|TWO_SIDED|95.0|0.552|1.105|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.105|0.552|0.0826
91677434|NCT05205772|183249353|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91677435|NCT05205772|183249353|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91677436|NCT05205772|183249353|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91677437|NCT05205772|183249353|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
91486803|NCT04308304|182846469|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
91486804|NCT04308304|182846469|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
91486805|NCT04308304|182846469|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
91486806|NCT04308304|182846470|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.67|||||TWO_SIDED|90.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
91486807|NCT04308304|182846470|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
91486808|NCT04308304|182846470|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.79|||||TWO_SIDED|95.0|0.59|1.06||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.06|0.59|
91486809|NCT04308304|182846470|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.08|0.51|
91486810|NCT04308304|182846471|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.62|||||TWO_SIDED|90.0|0.48|0.8||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.80|0.48|
91677438|NCT05205772|183249353|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
91677439|NCT05205772|183249353|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
91677440|NCT05205772|183249354|OTHER|||||||0.38||||||Adjusted for age.|Regression, Linear|||||||0.38
91677441|NCT05205772|183249355|OTHER|||||||0.67||||||Adjusted for age.|Regression, Linear|||||||0.67
91677442|NCT05205772|183249356|OTHER|||||||0.156|||||||Regression, Linear|||||||0.156
91677443|NCT03696953|183249365|OTHER|t test comparing||||||0.05|||||||t-test, 2 sided|||||||0.05
91677444|NCT03696953|183249366|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
91677445|NCT03696953|183249366|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
91677446|NCT03696953|183249367|OTHER|T test||||||0.01|||||||t-test, 2 sided|||Comparison of 36 week AP-GI-SA Scores between probiotic and placebo groups at 36 weeks||||0.01
91677447|NCT03696953|183249368|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
91677448|NCT03696953|183249369|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
91677449|NCT01106014|183249410|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|99.0|0.46|0.78||one-sided p-value|Log Rank|||The primary analysis was performed on the Full Analysis Set by a one-sided unstratified log-rank test||0.78|0.46|<0.0001
91692370|NCT01436370|183279665|SUPERIORITY_OR_OTHER|||||||0.763|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.763
91692371|NCT01436370|183279665|SUPERIORITY_OR_OTHER|||||||0.096|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.096
91717355|NCT00977197|183327467|SUPERIORITY_OR_OTHER|||||||0.03||||||Intent to Treat analysis; adjusted for age and gender, rank scale.|ANCOVA|||||||0.030
91486811|NCT04308304|182846471|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.67|||||TWO_SIDED|95.0|0.55|0.81||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.81|0.55|
91486812|NCT04308304|182846471|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.49|0.93||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.93|0.49|
91486813|NCT04308304|182846471|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.72|||||TWO_SIDED|95.0|0.54|0.98||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.98|0.54|
91717356|NCT00977197|183327468|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.016
91717357|NCT00977197|183327469|SUPERIORITY_OR_OTHER|||||||0.097||||||Intent to Treat analysis; not adjusted for age and gender.|Chi-squared|||||||0.097
91486814|NCT04308304|182846476|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.34|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
91486815|NCT04308304|182846477|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.22|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
91677450|NCT01106014|183249411|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|12.0||||0.0027|TWO_SIDED|99.0|1.0|24.0||One-sided p-value of the nonparametric ANCOVA, adjusted for 6-minute walk distance at baseline|ANCOVA||Point estimate and 2-sided 99% CI for location shift using the HodgesLehmann method|Non-parametric ANCOVA with 6MWD as covariate at baseline. Missing values were imputed based on the following imputation rules: 1) if patient was unable to walk at week 26, 0 meter was imputed, 2) if rule 1 did not apply, the second lowest observed 6MWD value (10 meters) at Week 26 was imputed. Missing values were imputed for 21.6% of the subjects.||24|1|0.0027
91677451|NCT01106014|183249412|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|It was assumed that the probabilities for absence of worsening in WHO FC at Week 26 were the same for both treatment groups|Odds Ratio, log|1.161||||0.2843|TWO_SIDED|99.0|0.811|1.664||Cochran-Mantel-Haenszel test stratified by WHO FC at baseline. For patients with missing NYHA/WHO FC at Week 26, the NYHA/WHO FC is considered as having worsened from baseline at Week 26. Missing values were imputed for 18.3% of subjects .|Cochran-Mantel-Haenszel|||||1.664|0.811|0.2843
91677452|NCT00062010|183249464|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percentage|8.8|||||TWO_SIDED|90.0|2.4|21.3||||||The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.||21.3|2.4|
91677453|NCT02766374|183249467|SUPERIORITY||||||>|0.1|||||||GEE regression|||||||>0.1
91677454|NCT00852969|183249468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.71|TWO_SIDED|95.0|-10.79|7.41|||t-test, 2 sided|||||7.41|-10.79|0.71
91677455|NCT00852969|183249469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.29|TWO_SIDED|95.0|-7.2|2.24|||t-test, 2 sided|||||2.24|-7.20|0.29
91677456|NCT01951885|183249483|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|47 patients per arm were needed to detect a 25% improvement in mucositis based on a one-sided test with 5% significance and 80% power.||||||0.05
91717358|NCT02295644|183327485|SUPERIORITY_OR_OTHER|||||||0.17||||||Interaction test of duty cycle and intensity for self reported pain score|ANOVA|||||||0.17
91717359|NCT02295644|183327485|SUPERIORITY_OR_OTHER|||||||0.14||||||Main effect of duty cycle on self reported pain score.|ANOVA|||||||0.14
91717360|NCT02295644|183327485|SUPERIORITY_OR_OTHER|||||||1||||||Main effect of intensity on self reported pain score.|ANOVA|||||||1.0
91717361|NCT02295644|183327486|SUPERIORITY_OR_OTHER|||||||0.24||||||Main effect for duty cycle.|ANOVA|||||||.24
91717362|NCT02295644|183327486|SUPERIORITY_OR_OTHER|||||||0.019||||||Main effect for intensity.|ANOVA|||||||0.019
91486816|NCT04308304|182846478|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.46|STANDARD_ERROR_OF_MEAN|60.8||||||||||||||||
91486817|NCT03950791|182846656|SUPERIORITY||Mann-Whitney U|3864.0|STANDARD_ERROR_OF_MEAN|302.0||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons, p \< .05 used as threshold for statistical significance|Independent-samples Mann-Whitney U|No adjustments for multiple comparisons|Standardized Test Statistic = .139|Morphine equivalent dosage outcome variables were not normally distributed (skewness values between 4.5 and 4.8, kurtosis values between 25.7 and 30.0), which necessitated non-parametric analysis using independent-samples Mann-Whitney U Test||||.89
91486818|NCT04191187|182846658|SUPERIORITY||PFS at 18 Months|70.8||||0.002|ONE_SIDED|90.0|59.2|||One sided log rank test|Log Rank||||||59.2|0.002
91486819|NCT02719327|182846664|SUPERIORITY||Slope|-2.18||||0.17|TWO_SIDED|95.0|-5.36|0.99||ASL values at 18 months were regressed on treatment group (IPE vs placebo) statistically controlling for age at baseline visit and ASL measured at baseline visit.|Regression, Linear|||The proposed study aims to investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow in the bilateral posterior cingulate gyrus as measured by arterial spin-labeling MRI . IPE was hypothesized to improve regional cerebral blood flow over placebo after 18 months.||0.99|-5.36|0.17
91486820|NCT02719327|182846665|SUPERIORITY||Slope|0.11||||0.12|TWO_SIDED|95.0|-0.04|0.25|||Regression, Linear|18 month Beta-amyloid(1-42) was regressed on group (IPE vs placebo) and covariates age at baseline visit and Beta-amyloid(1-42) at baseline visit.|Placebo group is the reference group.|Beta-amyloid(1-42) concentration in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.25|-0.04|.12
91486821|NCT02719327|182846665|SUPERIORITY||Slope|0.045||||0.05|TWO_SIDED|95.0|0.004|0.061|||Regression, Linear|log-transformed 18 month pTau181 was regressed on group (IPE vs placebo) and covariates age at baseline and log-transformed ptau181at baseline visit.|Placebo group is the reference group.|Phosphorylated tau (pTau181) measured in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.061|0.004|0.05
91677457|NCT01951885|183249486|NON_INFERIORITY|Cumulative incidence methods are compared using the Gray test with a p-value \<0.05|||||<|0.05|||||||Log Rank|||||||<0.05
91717363|NCT02295644|183327486|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANOVA|||Interaction of intensity and duty cycle.||||0.17
91717364|NCT02295644|183327487|SUPERIORITY_OR_OTHER|||||||0.034||||||Main effect for duty cycle.|ANOVA|||||||0.034
91717365|NCT02295644|183327487|SUPERIORITY_OR_OTHER|||||||0.475|||||||ANOVA|||Main effect for intensity.||||0.475
91717366|NCT02295644|183327487|SUPERIORITY_OR_OTHER|||||||0.178|||||||ANOVA|||Interaction of intensity and duty cycle.||||.178
91677458|NCT01951885|183249487|NON_INFERIORITY|Hospital stay will be compared between groups using the Wilcoxon rank sum test with a p value of 0.05.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91677459|NCT01951885|183249488|NON_INFERIORITY|TPN use will be compared using the Chi-square test.|||||<|0.05|||||||Chi-squared|||||||<0.05
91677460|NCT01951885|183249489|NON_INFERIORITY|Overall survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
91677461|NCT01951885|183249490|NON_INFERIORITY|Progression-free survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
91677462|NCT01951885|183249493|NON_INFERIORITY|Infusion times will be compared using the Wilcoxon rank sum test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91677463|NCT01951885|183249494|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
91677464|NCT01951885|183249495|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
91677465|NCT01951885|183249496|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Chi-squared|||||||<0.05
91677466|NCT01951885|183249497|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
91677467|NCT01951885|183249499|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
91677468|NCT01951885|183249500|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
91677469|NCT01951885|183249501|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
91677470|NCT01687478|183249503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.62|||||TWO_SIDED|95.0|-5.04|1.8|||||The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.|||1.80|-5.04|
91486822|NCT02719327|182846665|SUPERIORITY||Slope|0.046||||0.07|TWO_SIDED|95.0|-0.0008|0.106||18 months total Tau was regressed on Group (IPE vs placebo) and covariates age at baseline and total Tau at baseline.|Regression, Linear||Placebo group was the reference group.|Total tau was log-transformed prior to analysis to better approximate a normal distribution.||0.106|-0.0008|.07
91677471|NCT03716076|183249521|OTHER|mixed-effects linear regression|||||||||||||||||To compare time values to baseline, post-hoc Tukey's test was applied|||
91677472|NCT01276301|183249528|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.95|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|98.87|107.02|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||107.02|98.87|
91677473|NCT01276301|183249529|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|92.39|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|85.38|99.97|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||99.97|85.38|
91527559|NCT01189890|182930409|SUPERIORITY_OR_OTHER||Difference in Percent Incidence|-3.9||||0.009|TWO_SIDED|95.0|-7.5|-1.2|||Miettinen & Nurminen|Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.||||-1.2|-7.5|0.009
91677474|NCT01276301|183249530|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.77|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|90.0|98.87|106.83|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||106.83|98.87|
91677475|NCT01971970|183249562|EQUIVALENCE|The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.|||||<|0.05|||||||Paired t-test,FDR 1.5fold,FDRvalue≤ 0.05|||The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.||||< 0.05
91677476|NCT01971970|183249563|OTHER|||||||0.2616||||||Kaplan-Meier curve comparing the percentage of children and adults on continued anti-TNF therapy over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding continued anti-TNF therapy, reflecting maintenance of response at 12 and 18 months.||||0.2616
91677477|NCT01971970|183249564|OTHER|||||||0.0177||||||Kaplan-Meier curve comparing the percentage of children and adults with therapy intensification over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding the escalation of anti-TNF therapy (dose increase above 5 mg/kg and/or interval shortening to less than 8 weeks)||||0.0177
91677478|NCT01831765|183249571|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.23|-0.07||||||Change from baseline in HbA1c analysed using a mixed effect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.07|-0.23|
91692372|NCT01436370|183279665|SUPERIORITY_OR_OTHER|||||||0.157|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21||||0.157
91692373|NCT01436370|183279665|SUPERIORITY_OR_OTHER|||||||0.705|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.705
91692374|NCT01436370|183279665|SUPERIORITY_OR_OTHER|||||||0.132|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.132
91486823|NCT02719327|182846666|SUPERIORITY||Slope|0.006||||0.48|TWO_SIDED|95.0|-0.009|0.023|||Linear Mixed Effects model|Covariates included education level, gender, and age at baseline visit.|Placebo group was the reference group.|Four cognitive tests were standardized (baseline mean and standard deviation) prior to averaging to create the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) score. The final composite score was standardized again using baseline mean and standard deviation (range -3.15 to 3.10). Higher scores indicate better cognitive performance. A linear mixed effects model was used to determine if change in ADCS-PACC composite scores was modified by treatment group.||0.023|-0.009|.48
91486824|NCT03924869|182846674|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2932|TWO_SIDED|95.0|0.69|1.24||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|||"Hazard ratio and 95% confidence intervals (CIs) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||1.24|0.69|0.29320
91526750|NCT02395133|182928902|SUPERIORITY||Percentage difference|21.4|||=|0.013|TWO_SIDED|95.0|4.86|38.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||38.00|4.86|= 0.0130
91527560|NCT01189890|182930412|SUPERIORITY_OR_OTHER||Difference in LS Means|6.7|||||TWO_SIDED|95.0|0.7|12.7|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline FPG.||||12.7|0.7|
91677479|NCT01831765|183249571|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.04|0.12||||||Change from baseline in HbA1c analysed using a mixedeffect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.12|-0.04|
91677480|NCT04561375|183249594|SUPERIORITY||Proportional odds ratio|0.37||||0.067|TWO_SIDED|95.0|0.13|1.07|||proportional odds logistic regression|In the analysis, 100 µg and 150 µg were merged as one level since too few cases used 150 µg.||||1.07|0.13|0.067
91677481|NCT04561375|183249595|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.147|TWO_SIDED|97.5|-5.8|26.0|||Regression, Linear|||||26|-5.8|0.147
91677482|NCT04561375|183249596|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.463|TWO_SIDED|97.5|-18.0|34.0|||Regression, Linear|||||34|-18|0.463
91677483|NCT04561375|183249597|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.032|TWO_SIDED|95.0|-25.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-25|0.032
91677484|NCT00117325|183249630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.335||||0.05|TWO_SIDED|95.0|-0.67|0.0|||ANCOVA|Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.67|0.050
91677485|NCT00117325|183249631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.027|TWO_SIDED|95.0|-0.74|-0.05||Week 1-4|ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.05|-0.74|0.027
91677486|NCT00117325|183249632|SUPERIORITY_OR_OTHER|||||||0.184|||||||Regression, Logistic|logistic regression adjusting for age, gender, investigator, and treatment.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.|Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.|||0.184
91677487|NCT00117325|183249633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.051|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.70|0.051
91677488|NCT00117325|183249634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.304||||0.076|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis||0.03|-0.64|0.076
91677489|NCT00117325|183249635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.51||||0.093|TWO_SIDED|95.0|-9.77|0.75|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.75|-9.77|0.093
91677490|NCT00117325|183249636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.372||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.90|-11.8|0.023
91677491|NCT00117325|183249637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.118||||0.061|TWO_SIDED|95.0|-0.24|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.01|-0.24|0.061
91677492|NCT00117325|183249637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.061|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion||0.01|-0.25|0.061
91677493|NCT00117325|183249637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.095||||0.138|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.03|-0.22|0.138
91677494|NCT00117325|183249638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.113||||0.087|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.02|-0.24|0.087
91677495|NCT00117325|183249638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||-0.03|-0.30|0.015
91677496|NCT00117325|183249638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.112||||0.106|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.25|0.106
91677497|NCT00117325|183249639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.132||||0.048|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea||-0.00|-0.26|0.048
91677498|NCT00117325|183249639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.076|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion||0.01|-0.26|0.076
91677499|NCT00117325|183249639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.164|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip||0.04|-0.22|0.164
91677500|NCT00117325|183249640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.136|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.03|-0.22|0.136
91677501|NCT00117325|183249640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1||95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||0.02|-0.24|0.100
91677502|NCT00117325|183249640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.24|0.100
91717367|NCT00477685|183327496|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.||||0.01
91717368|NCT01038687|183327528|SUPERIORITY|||||||0.059|||||||ANCOVA|||||||0.059
91489397|NCT02484690|182851577|SUPERIORITY||Difference in Least Squares Means|19.45||||0.1624|TWO_SIDED|80.0|1.61|37.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||37.29|1.61|0.1624
91677503|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.011|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1||-0.10|-0.80|0.011
91677504|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.325||||0.089|TWO_SIDED|95.0|-0.7|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2||0.05|-0.70|0.089
91677505|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.052|TWO_SIDED|95.0|-0.79|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3||0.00|-0.79|0.052
91717369|NCT01038687|183327528|SUPERIORITY|||||||0.18|||||||Dunnett's test|||15mg dose vs placebo||||0.18
91717370|NCT01038687|183327528|SUPERIORITY|||||||0.04|||||||Dunnett's test|||20mg dose vs placebo||||0.04
91717371|NCT01038687|183327529|SUPERIORITY|||||||0.81|||||||ANCOVA|||||||0.81
91677506|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.187|TWO_SIDED|95.0|-0.65|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4||0.13|-0.65|0.187
91677507|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.298||||0.164|TWO_SIDED|95.0|-0.72|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5||0.12|-0.72|0.164
91677508|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.573||||0.008|TWO_SIDED|95.0|-1.0|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6||-0.15|-1.00|0.008
91677509|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.376||||0.082|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7||0.05|-0.80|0.082
91677510|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.296|TWO_SIDED|95.0|-0.67|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8||0.20|-0.67|0.296
91677511|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.191||||0.383|TWO_SIDED|95.0|-0.62|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9||0.24|-0.62|0.383
91717372|NCT01038687|183327529|SUPERIORITY|||||||0.89|||||||Dunnett's test|||15mg dose vs placebo||||0.89
91717373|NCT01038687|183327529|SUPERIORITY|||||||0.76|||||||Dunnett's test|||20mg dose vs placebo||||0.76
91717374|NCT01038687|183327530|SUPERIORITY|||||||0.075|||||||ANCOVA|||||||0.075
91677512|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.048|TWO_SIDED|95.0|-0.92|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10||-0.00|-0.92|0.048
91677513|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.172||||0.469|TWO_SIDED|95.0|-0.64|0.29|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11||0.29|-0.64|0.469
91677514|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.151|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12||0.12|-0.80|0.151
91677515|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.344||||0.145|TWO_SIDED|95.0|-0.81|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13||0.12|-0.81|0.145
91677516|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.297|TWO_SIDED|95.0|-0.68|0.21|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14||0.21|-0.68|0.297
91677517|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.094|TWO_SIDED|95.0|-0.82|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15||0.07|-0.82|0.094
91677518|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.064|TWO_SIDED|95.0|-0.89|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16||0.03|-0.89|0.064
91677519|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.563||||0.019|TWO_SIDED|95.0|-1.03|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17||-0.09|-1.03|0.019
91677520|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.457||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18||-0.01|-0.90|0.044
91677521|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.633||||0.007|TWO_SIDED|95.0|-1.09|-0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19||-0.17|-1.09|0.007
91677522|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.348|TWO_SIDED|95.0|-0.69|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20||0.24|-0.69|0.348
91677523|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.281||||0.243|TWO_SIDED|95.0|-0.76|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21||0.19|-0.76|0.243
91677524|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595||||0.014|TWO_SIDED|95.0|-1.07|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22||-0.12|-1.07|0.014
91677525|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.474||||0.055|TWO_SIDED|95.0|-0.96|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23||0.01|-0.96|0.055
91677526|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.062|TWO_SIDED|95.0|-0.95|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24||0.02|-0.95|0.062
91677527|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.079|TWO_SIDED|95.0|-0.91|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25||0.05|-0.91|0.079
91677528|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.019|TWO_SIDED|95.0|-1.06|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26||-0.10|-1.06|0.019
91677529|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.056|TWO_SIDED|95.0|-0.97|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27||0.01|-0.97|0.056
91677530|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.659||||0.018|TWO_SIDED|95.0|-1.2|-0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28||-0.11|-1.20|0.018
91677531|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.194|TWO_SIDED|95.0|-0.56|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1||0.1|-0.56|0.194
91677532|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.263||||0.134|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2||0.08|-0.61|0.134
91677533|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.091|TWO_SIDED|95.0|-0.67|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3||0.05|-0.67|0.091
91677534|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278||||0.131|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4||0.08|-0.64|0.131
91526751|NCT02395133|182928902|SUPERIORITY||Percentage difference|33.5|||=|0.0003|TWO_SIDED|95.0|17.38|49.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||49.72|17.38|= 0.0003
91677535|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.483|TWO_SIDED|95.0|-0.49|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5||0.23|-0.49|0.483
91677536|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.137|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6||0.10|-0.70|0.137
91677537|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.142|TWO_SIDED|95.0|-0.69|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7||0.10|-0.69|0.142
91677538|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.22|TWO_SIDED|95.0|-0.64|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8||0.15|-0.64|0.220
91677539|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.081|TWO_SIDED|95.0|-0.79|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9||0.05|-0.79|0.081
91677540|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.453||||0.034|TWO_SIDED|95.0|-0.87|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10||-0.04|-0.87|0.034
91677541|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.314||||0.15|TWO_SIDED|95.0|-0.74|0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11||0.11|-0.74|0.150
91677542|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.333||||0.111|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12||0.08|-0.74|0.111
91677543|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.261|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13||0.19|-0.69|0.261
91677544|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.123|TWO_SIDED|95.0|-0.78|0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14||0.09|-0.78|0.123
91677545|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.415||||0.056|TWO_SIDED|95.0|-0.84|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15||0.01|-0.84|0.056
91677546|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.566||||0.011|TWO_SIDED|95.0|-1.0|-0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16||-0.13|-1.00|0.011
91677547|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.009|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17||-0.15|-1.03|0.009
91677548|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.175|TWO_SIDED|95.0|-0.74|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18||0.13|-0.74|0.175
91677549|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.449||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19||-0.02|-0.87|0.039
91677550|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.315||||0.152|TWO_SIDED|95.0|-0.75|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20||0.12|-0.75|0.152
91677551|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.424||||0.063|TWO_SIDED|95.0|-0.87|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21||0.02|-0.87|0.063
91677552|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.454||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22||-0.01|-0.90|0.044
91677553|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312||||0.179|TWO_SIDED|95.0|-0.77|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23||0.14|-0.77|0.179
91677554|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.479||||0.034|TWO_SIDED|95.0|-0.92|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24||-0.04|-0.92|0.034
91677555|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.157||||0.505|TWO_SIDED|95.0|-0.62|0.31|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25||0.31|-0.62|0.505
91677556|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.317||||0.186|TWO_SIDED|95.0|-0.79|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26||0.15|-0.79|0.186
91717375|NCT01038687|183327530|SUPERIORITY|||||||0.058|||||||Dunnett's test|||15mg dose vs placebo||||0.058
91717376|NCT01038687|183327530|SUPERIORITY|||||||0.164|||||||Dunnett's test|||20mg dose vs placebo||||0.164
91486825|NCT03924869|182846675|OTHER||Hazard Ratio (HR)|1.33||||0.93971|TWO_SIDED|95.0|0.93|1.9||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|Per protocol, since the EFS null hypothesis was not rejected, the OS hypothesis was not formally tested and the p-value should be considered nominal.||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.90|0.93|0.93971
91717377|NCT01038687|183327531|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
91717378|NCT01038687|183327531|SUPERIORITY|||||||0.98|||||||Dunnett's test|||15mg vs placebo||||0.98
91717379|NCT01038687|183327531|SUPERIORITY|||||||0.079|||||||Dunnett's test|||20mg vs placebo||||0.079
91717380|NCT01038687|183327532|SUPERIORITY|||||||0.058|||||||ANCOVA|||||||0.058
91717381|NCT01038687|183327532|SUPERIORITY|||||||0.32|||||||Dunnett's test|||15mg dose vs placebo||||0.32
91717382|NCT01038687|183327532|SUPERIORITY|||||||0.034|||||||Dunnett's test|||20mg dose vs placebo||||0.034
91717383|NCT01038687|183327533|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
91717384|NCT01038687|183327533|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
91717385|NCT01038687|183327533|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg vs placebo||||0.001
91717386|NCT01038687|183327534|SUPERIORITY|||||||0.091|||||||ANCOVA|||||||0.091
91717387|NCT01038687|183327534|SUPERIORITY|||||||0.99|||||||Dunnett's test|||15mg dose vs placebo||||0.99
91717388|NCT01038687|183327534|SUPERIORITY|||||||0.103|||||||Dunnett's test|||20mg vs placebo||||0.103
91486826|NCT03924869|182846676|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.74|1.42||Per protocol, there was no hypothesis pre-specified for TDDM to be formally tested.||||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.42|0.74|
91717389|NCT01038687|183327535|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
91717390|NCT01038687|183327535|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
91717391|NCT01038687|183327535|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg dose vs placebo||||0.001
91717392|NCT01038687|183327536|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91717393|NCT01038687|183327536|SUPERIORITY|||||||0.053|||||||Dunnett's test|||15mg dose vs placebo||||0.053
91717394|NCT01038687|183327536|SUPERIORITY|||||||0.002|||||||Dunnett's test|||20mg dose vs placebo||||0.002
91717395|NCT02783911|183327537|SUPERIORITY|||||||0.808|||||||Chi-squared|||||||0.808
91717396|NCT02616783|183327538|SUPERIORITY||Difference in Percentages|2.427|||<|0.001|TWO_SIDED|95.0|1.337|3.517|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||3.517|1.337|<0.001
91717397|NCT02616783|183327539|SUPERIORITY||Difference in percentages|2.036|||<|0.001|TWO_SIDED|95.0|1.168|2.904|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.904|1.168|<0.001
91717398|NCT02616783|183327540|SUPERIORITY||Difference in percentages|1.749|||<|0.001|TWO_SIDED|95.0|0.726|2.771|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||2.771|0.726|<0.001
91717399|NCT02616783|183327541|SUPERIORITY||Difference in percentages|1.351|||<|0.001|TWO_SIDED|95.0|0.602|2.099|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.099|0.602|<0.001
91717400|NCT02616783|183327542|SUPERIORITY||Difference in percentages|-5.5||||0.18|TWO_SIDED|95.0|-11.8|1.6||P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Fisher Exact||Differences in percentages and 95% CI were generated based on exact method.|||1.6|-11.8|0.18
91717401|NCT02616783|183327543|SUPERIORITY||Difference in percentages|-1.0||||1|TWO_SIDED|95.0|-8.5|9.3|||Fisher Exact|P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Differences in percentages and 95% CI were generated based on exact method.|||9.3|-8.5|1.00
91717402|NCT02616783|183327544|SUPERIORITY||Difference in LSM|52.0||||0.053|TWO_SIDED|95.0|-1.0|106.0|||ANOVA|The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.||||106|-1|0.053
91717403|NCT02616783|183327545|SUPERIORITY||Difference in LSM|57.0||||0.051|TWO_SIDED|95.0|0.0|115.0|||ANOVA|The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.||||115|0|0.051
91717404|NCT01614470|183327553|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|10.678|||<|0.0001|TWO_SIDED|95.0|7.2559|14.1|||Mixed Models Analysis|||||14.1000|7.2559|<0.0001
91717405|NCT01614470|183327554|SUPERIORITY_OR_OTHER||LS mean difference|0.6624|||<|0.0001|TWO_SIDED|95.0|0.3366|0.9881|||Mixed Models Analysis|||||0.9881|0.3366|<0.0001
91717406|NCT01614470|183327556|SUPERIORITY_OR_OTHER||LS mean difference|-49.1667|||<|0.0001|TWO_SIDED|95.0|-56.9527|-41.3807|||Mixed Models Analysis|||||-41.3807|-56.9527|<0.0001
91717407|NCT01614470|183327559|SUPERIORITY_OR_OTHER||LS mean difference|9.6105||||0.0004|TWO_SIDED|95.0|4.4874|14.7336|||Mixed Models Analysis|||||14.7336|4.4874|0.0004
91717408|NCT01328964|183327568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.974||The p-value is a comparison of the combined hospitalization/emergency department visit endpoint|Regression, Cox|||||0.974|0.51|<0.0001
91486827|NCT03924869|182846679|OTHER||Mean Difference (Final Values)|-1.21||||0.5187|TWO_SIDED|95.0|-4.9|2.48|||cLDA model|||"Stats:~LS Mean change and 95% CIs were based on a constrained longitudinal data analysis (cLDA) model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||2.48|-4.90|0.5187
91527561|NCT01189890|182930413|SUPERIORITY_OR_OTHER||Relative Risk|0.7|||||TWO_SIDED|95.0|0.6|0.9|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.9|0.6|
91527562|NCT01189890|182930414|SUPERIORITY_OR_OTHER||Relative Risk|0.4|||||TWO_SIDED|95.0|0.3|0.7|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.7|0.3|
91677557|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.283||||0.234|TWO_SIDED|95.0|-0.75|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27||0.18|-0.75|0.234
91677558|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.645||||0.017|TWO_SIDED|95.0|-1.17|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28||-0.12|-1.17|0.017
91677559|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.095|TWO_SIDED|95.0|-0.7|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1||0.06|-0.70|0.095
91677560|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.236|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2||0.15|-0.61|0.236
91677561|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.255||||0.205|TWO_SIDED|95.0|-0.65|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3||0.14|-0.65|0.205
91677562|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.084|TWO_SIDED|95.0|-0.73|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4||0.05|-0.73|0.084
91677563|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.475|TWO_SIDED|95.0|-0.55|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5||0.26|-0.55|0.475
91677564|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296||||0.178|TWO_SIDED|95.0|-0.73|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6||0.14|-0.73|0.178
91677565|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.406||||0.071|TWO_SIDED|95.0|-0.85|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7||0.04|-0.85|0.071
91677566|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.621|TWO_SIDED|95.0|-0.55|0.33|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8||0.33|-0.55|0.621
91677567|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.372|TWO_SIDED|95.0|-0.66|0.25|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9||0.25|-0.66|0.372
91677568|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.452||||0.046|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10||-0.01|-0.90|0.046
91677569|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.302||||0.183|TWO_SIDED|95.0|-0.75|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11||0.14|-0.75|0.183
91677570|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.226||||0.32|TWO_SIDED|95.0|-0.67|0.22|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12||0.22|-0.67|0.320
91677571|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.188||||0.431|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13||0.28|-0.66|0.431
91677572|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.191|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14||0.15|-0.75|0.191
91677573|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.475||||0.043|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15||-0.02|-0.94|0.043
91677574|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.619||||0.009|TWO_SIDED|95.0|-1.08|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16||-0.16|-1.08|0.009
91677575|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.495||||0.04|TWO_SIDED|95.0|-0.97|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17||-0.02|-0.97|0.040
91677576|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.249|TWO_SIDED|95.0|-0.71|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18||0.18|-0.71|0.249
91677577|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.536||||0.023|TWO_SIDED|95.0|-1.0|-0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19||-0.07|-1.00|0.023
91717409|NCT01328964|183327569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-19.0|-9.0||P-value is based on the differences in the total monthly asthma costs|Regression, Linear|||||-9|-19|<0.001
91717410|NCT01328964|183327570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0495|TWO_SIDED|95.0|0.565|0.999||P-value is based on the comparison of combined endpoint of hospitalization/emergency department visits|Regression, Cox|||||0.999|0.565|0.0495
91717411|NCT01328964|183327571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-27.0||P-value is based on difference in total monthly asthma costs|Regression, Linear|||||-27|-28|<0.0001
91717412|NCT03669588|183327624|SUPERIORITY||Odds Ratio (OR)|4.951|||<|0.0001|TWO_SIDED|95.0|2.213|11.528|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese versus (vs) non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||11.528|2.213|<0.0001
91717413|NCT03669588|183327625|SUPERIORITY||Odds Ratio (OR)|10.842|||<|0.0001|TWO_SIDED|95.0|4.179|31.2|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline QMG total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||31.200|4.179|<0.0001
91717414|NCT03669588|183327626|SUPERIORITY||Odds Ratio (OR)|3.699|||<|0.0001|TWO_SIDED|95.0|1.854|7.578|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the overall population, stratified by AChR-Ab status (seropositive vs seronegative), Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||7.578|1.854|<0.0001
91717415|NCT03669588|183327627|SUPERIORITY||Least square means difference|22.065|STANDARD_ERROR_OF_MEAN|5.616||0.0001|TWO_SIDED|95.0|10.949|33.181|||ANCOVA|||Analysis of covariance (ANCOVA) in the AChR-Ab seropositive population with treatment, baseline MG-ADL total score, Japanese vs non-Japanese, and NSID vs no NSID as concomitant gMG treatment as the covariates.||33.181|10.949|0.0001
91717416|NCT03669588|183327628|SUPERIORITY|||||||0.2604|||||||Log Rank|||Analysis was performed in the AChR-Ab seropositive population and the p-value was calculated using the log-rank test, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment.||||0.2604
91717417|NCT01721447|183327630|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
91486828|NCT03924869|182846680|OTHER||Mean Difference (Final Values)|-4.34||||0.0906|TWO_SIDED|95.0|-9.38|0.69|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||0.69|-9.38|0.0906
91717418|NCT01721447|183327631|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
91717419|NCT00794664|183327640|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C was approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Enrollment was to be conducted such that at least 51 patients were randomized to allow for potential exclusions from an analysis set.||||<0.001
91717420|NCT00794664|183327642|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91717421|NCT00794664|183327644|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
91717422|NCT00794664|183327646|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
91677578|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.321|TWO_SIDED|95.0|-0.71|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20||0.23|-0.71|0.321
91677579|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.568||||0.019|TWO_SIDED|95.0|-1.04|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21||-0.09|-1.04|0.019
91677580|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.419||||0.092|TWO_SIDED|95.0|-0.91|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22||0.07|-0.91|0.092
91677581|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.404|TWO_SIDED|95.0|-0.69|0.28|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23||0.28|-0.69|0.404
91677582|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.546||||0.027|TWO_SIDED|95.0|-1.03|-0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24||-0.06|-1.03|0.027
91677583|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.227||||0.357|TWO_SIDED|95.0|-0.71|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25||0.26|-0.71|0.357
91677584|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.403||||0.114|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26||0.10|-0.90|0.114
91677585|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.307||||0.228|TWO_SIDED|95.0|-0.81|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27||0.19|-0.81|0.228
91677586|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.725||||0.012|TWO_SIDED|95.0|-1.29|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28||-0.16|-1.29|0.012
91677587|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.643|TWO_SIDED|95.0|-0.49|0.3|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1||0.30|-0.49|0.643
91677588|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279||||0.15|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2||0.10|-0.66|0.150
91677589|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291||||0.162|TWO_SIDED|95.0|-0.7|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3||0.12|-0.70|0.162
91677590|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.244||||0.242|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4||0.17|-0.65|0.242
91677591|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.223||||0.278|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5||0.18|-0.63|0.278
91677592|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.282||||0.2|TWO_SIDED|95.0|-0.71|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6||0.15|-0.71|0.200
91677593|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.456|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7||0.27|-0.60|0.456
91677594|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.076|TWO_SIDED|95.0|-0.81|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8||0.04|-0.81|0.076
91677595|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.396||||0.084|TWO_SIDED|95.0|-0.85|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9||0.05|-0.85|0.084
91677596|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.481||||0.04|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10||-0.02|-0.94|0.040
91677597|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.405||||0.09|TWO_SIDED|95.0|-0.87|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11||0.06|-0.87|0.090
91677598|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.432||||0.06|TWO_SIDED|95.0|-0.88|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12||0.02|-0.88|0.060
91677599|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.277||||0.252|TWO_SIDED|95.0|-0.75|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13||0.20|-0.75|0.252
91677600|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.229|TWO_SIDED|95.0|-0.79|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14||0.19|-0.79|0.229
91677601|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.109|TWO_SIDED|95.0|-0.83|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15||0.08|-0.83|0.109
91677602|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.484|||||TWO_SIDED|95.0|-0.96|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16||-0.01|-0.96|
91677603|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.003|TWO_SIDED|95.0|-1.17|-0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17||-0.23|-1.17|0.003
91677604|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.326||||0.182|TWO_SIDED|95.0|-0.81|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18||0.15|-0.81|0.182
91677605|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.194|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19||0.15|-0.75|0.194
91677606|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.129|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20||0.10|-0.80|0.129
91677607|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.292||||0.232|TWO_SIDED|95.0|-0.77|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21||0.19|-0.77|0.232
91677608|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.499||||0.042|TWO_SIDED|95.0|-0.98|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22||-0.02|-0.98|0.042
91677609|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.356||||0.15|TWO_SIDED|95.0|-0.84|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23||0.13|-0.84|0.150
91677610|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.398||||0.09|TWO_SIDED|95.0|-0.86|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24||0.06|-0.86|0.090
91677611|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.909|TWO_SIDED|95.0|-0.52|0.46|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25||0.46|-0.52|0.909
91677612|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.233||||0.354|TWO_SIDED|95.0|-0.73|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26||0.26|-0.73|0.354
91677613|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.245|TWO_SIDED|95.0|-0.78|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27||0.20|-0.78|0.245
91677614|NCT00117325|183249641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.601||||0.038|TWO_SIDED|95.0|-1.17|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28||-0.03|-1.17|0.038
91677615|NCT00759187|183249642|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors)|ANOVA|||||||<0.05
91677616|NCT02666352|183249647|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
91677617|NCT02666352|183249647|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
91526752|NCT02395133|182928902|SUPERIORITY||Percentage difference|42.1|||<|0.0001|TWO_SIDED|95.0|28.36|55.76||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||55.76|28.36|<0.0001
91677618|NCT02666352|183249648|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.88|2.31||||||||2.31|0.88|
91677619|NCT02666352|183249648|OTHER||Geometric least-squares mean ratio|2.15||||||90.0|1.33|3.48||||||||3.48|1.33|
91677620|NCT02666352|183249649|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
91677621|NCT02666352|183249649|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
91677622|NCT02666352|183249650|OTHER||Geometric least-squares mean ratio|1.32|||||TWO_SIDED|90.0|0.81|2.15||||||||2.15|0.81|
91677623|NCT02666352|183249650|OTHER||Geometric least-squares mean ratio|1.81|||||TWO_SIDED|90.0|1.11|2.94||||||||2.94|1.11|
91677624|NCT02666352|183249656|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.1||||||||1.10|0.58|
91677625|NCT02666352|183249656|OTHER||Geometric least-squares mean ratio|0.84|||||TWO_SIDED|90.0|0.61|1.16||||||||1.16|0.61|
91677626|NCT02666352|183249657|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.11||||||||1.11|0.58|
91677627|NCT02666352|183249657|OTHER||Geometric least-squares mean ratio|0.86||||||90.0|0.62|1.18||||||||1.18|0.62|
91677628|NCT02666352|183249658|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.57|1.05||||||||1.05|0.57|
91677629|NCT02666352|183249658|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.54|0.99||||||||0.99|0.54|
91677630|NCT02666352|183249659|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.13||||||||1.13|0.61|
91677631|NCT02666352|183249659|OTHER||Geometric least-squares mean ratio|0.75|||||TWO_SIDED|90.0|0.55|1.01||||||||1.01|0.55|
91677632|NCT02666352|183249660|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||||1.15|0.60|
91677633|NCT02666352|183249660|OTHER||Geometric least-squares mean ratio|0.82|||||TWO_SIDED|90.0|0.59|1.13||||||||1.13|0.59|
91677634|NCT02666352|183249664|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.52|0.9||||||||0.90|0.52|
91677635|NCT02666352|183249664|OTHER||Geometric least-squares mean ratio|0.66|||||TWO_SIDED|90.0|0.5|0.86||||||||0.86|0.50|
91677636|NCT02666352|183249665|OTHER||Geometric least-squares mean ratio|0.64|||||TWO_SIDED|90.0|0.48|0.86||||||||0.86|0.48|
91677637|NCT02666352|183249665|OTHER||Geometric least-squares mean ratio|0.61||||||90.0|0.46|0.82||||||||0.82|0.46|
91677638|NCT02666352|183249666|OTHER||Geometric least-squares mean ratio|0.79|||||TWO_SIDED|90.0|0.62|1.01||||||||1.01|0.62|
91677639|NCT02666352|183249666|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.63|1.02||||||||1.02|0.63|
91677640|NCT02666352|183249667|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.61|1.05||||||||1.05|0.61|
91677641|NCT02666352|183249667|OTHER||Geometric least-squares mean ratio|0.78|||||TWO_SIDED|90.0|0.6|1.03||||||||1.03|0.60|
91677642|NCT02666352|183249668|OTHER||Geometric least-squares mean ratio|0.71|||||TWO_SIDED|90.0|0.57|0.89||||||||0.89|0.57|
91677643|NCT02666352|183249668|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.58|0.91||||||||0.91|0.58|
91677644|NCT02666352|183249671|OTHER||Geometric least-squares mean ratio (GMR)|1.16|||||TWO_SIDED|90.0|0.85|1.58||||||||1.58|0.85|
91677645|NCT02666352|183249671|OTHER||Geometric least-squares mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.85||||||||1.85|1.00|
91677646|NCT02666352|183249672|OTHER||Geometric least-squares mean ratio|1.24|||||TWO_SIDED|90.0|0.91|1.68||||||||1.68|0.91|
91677647|NCT02666352|183249672|OTHER||Geometric least-squares mean ratio|1.58||||||90.0|1.17|2.14||||||||2.14|1.17|
91486829|NCT03924869|182846681|OTHER||Mean Difference (Final Values)|1.24||||0.5482|TWO_SIDED|95.0|-2.83|5.31|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||5.31|-2.83|0.5482
91677648|NCT02666352|183249673|OTHER||Geometric least-squares mean ratio|0.89|||||TWO_SIDED|90.0|0.6|1.33||||||||1.33|0.60|
91486830|NCT03924869|182846682|OTHER||Mean Difference (Final Values)|-0.99||||0.7253|TWO_SIDED|95.0|-6.5|4.53|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||4.53|-6.50|0.7253
91677649|NCT02666352|183249673|OTHER||Geometric least-squares mean ratio|0.9|||||TWO_SIDED|90.0|0.6|1.34||||||||1.34|0.60|
91677650|NCT02666352|183249674|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.45|1.3||||||||1.30|0.45|
91677651|NCT02666352|183249674|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.4|1.14||||||||1.14|0.40|
91677652|NCT02666352|183249675|OTHER||Geometric least-squares mean ratio|1.2|||||TWO_SIDED|90.0|0.9|1.6||||||||1.60|0.90|
91677653|NCT02666352|183249675|OTHER||Geometric least-squares mean ratio|1.41|||||TWO_SIDED|90.0|1.06|1.87||||||||1.87|1.06|
91677654|NCT04795908|183249700|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.1997|||||||ANOVA|||||||0.1997
91677655|NCT04795908|183249701|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.076|||||||ANOVA|||||||0.076
91677656|NCT04795908|183249702|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.6228|||||||ANOVA|||||||0.6228
91677657|NCT04795908|183249703|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8984|||||||ANOVA|||||||0.8984
91677658|NCT04795908|183249704|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8188|||||||ANOVA|||||||0.8188
91677659|NCT04795908|183249705|NON_INFERIORITY|Looking for statistically significant differences between groups||||||0.0288|||||||ANOVA|||||||0.0288
91677660|NCT04795908|183249706|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.0524|||||||ANOVA|||||||0.0524
91677661|NCT00311311|183249710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0445|TWO_SIDED|95.0|0.001|0.07||P-value and 95% CI for least square (LS) mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|12 months post-transplant||0.070|0.001|0.0445
91677662|NCT00311311|183249710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.0288|TWO_SIDED|95.0|0.004|0.064||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||0.064|0.004|0.0288
91677663|NCT00311311|183249710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0269|TWO_SIDED|95.0|0.004|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||0.060|0.004|0.0269
91677664|NCT00311311|183249710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.097|TWO_SIDED|95.0|-0.005|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||0.060|-0.005|0.0970
91677665|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.39|1.09||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 12 Months Post-transplant||1.09|0.39|<.0001
91677666|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.0022|TWO_SIDED|95.0|0.15|0.67||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 12 Months Post-transplant||0.67|0.15|0.0022
91677667|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.1612|TWO_SIDED|95.0|-0.03|0.19||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 12 Months Post-transplant||0.19|-0.03|0.1612
91677668|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.26|0.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 12 Months Post-transplant||0.86|0.26|0.0005
91677669|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0006|TWO_SIDED|95.0|0.3|1.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 18 Months Post-transplant||1.02|0.30|0.0006
91677670|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.0126|TWO_SIDED|95.0|0.08|0.61||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 18 Months Post-transplant||0.61|0.08|0.0126
91677671|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.238|TWO_SIDED|95.0|-0.04|0.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 18 Months Post-transplant||0.17|-0.04|0.2380
91677672|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0003|TWO_SIDED|95.0|0.27|0.88||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 18 Months Post-transplant||0.88|0.27|0.0003
91677673|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0065|TWO_SIDED|95.0|0.17|1.0||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 24 Months Post-transplant||1.00|0.17|0.0065
91677674|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0845|TWO_SIDED|95.0|-0.04|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 24 Months Post-transplant||0.60|-0.04|0.0845
91677675|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3742|TWO_SIDED|95.0|-0.06|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 24 Months Post-transplant||0.16|-0.06|0.3742
91677676|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0006|TWO_SIDED|95.0|0.27|0.92||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 24 Months Post-transplant||0.92|0.27|0.0006
91677677|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.1488|TWO_SIDED|95.0|-0.16|1.03||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 36 Months Post-transplant||1.03|-0.16|0.1488
91677678|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.546|TWO_SIDED|95.0|-0.33|0.62||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 36 Months Post-transplant||0.62|-0.33|0.5460
91677679|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.7511|TWO_SIDED|95.0|-0.12|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 36 Months Post-transplant||0.16|-0.12|0.7511
91526753|NCT02395133|182928903|SUPERIORITY||Percentage difference|18.5|||=|0.0209|TWO_SIDED|95.0|4.14|32.91||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||32.91|4.14|= 0.0209
91677680|NCT00311311|183249713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.0048|TWO_SIDED|95.0|0.2|1.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 36 Months Post-transplant||1.06|0.20|0.0048
91677681|NCT00311311|183249714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78||||0.1757|TWO_SIDED|95.0|-0.36|1.91||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.91|-0.36|0.1757
91677682|NCT00311311|183249714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0509|TWO_SIDED|95.0|0.0|1.89||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.89|-0.00|0.0509
91677683|NCT00311311|183249714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11||||0.0683|TWO_SIDED|95.0|-0.09|2.31||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.31|-0.09|0.0683
91677684|NCT00311311|183249715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.47||||0.2741|TWO_SIDED|95.0|-105.79|30.85||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.85|-105.79|0.2741
91677685|NCT00311311|183249715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.97||||0.4865|TWO_SIDED|95.0|-77.48|37.53||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||37.53|-77.48|0.4865
91692375|NCT02770170|183279666|OTHER|||||||0.7271||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod quadratic model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7271
91526754|NCT02395133|182928903|SUPERIORITY||Percentage difference|29.7|||=|0.0007|TWO_SIDED|95.0|14.89|44.42||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||44.42|14.89|= 0.0007
91677686|NCT00311311|183249715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48||||0.9339|TWO_SIDED|95.0|-62.54|57.59||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||57.59|-62.54|0.9339
91677687|NCT00311311|183249716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.4892|TWO_SIDED|95.0|-0.005|0.011||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.011|-0.005|0.4892
91677688|NCT00311311|183249716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.0514|TWO_SIDED|95.0|0.0|0.012||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||0.012|-0.000|0.0514
91677689|NCT00311311|183249716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.009||||0.118|TWO_SIDED|95.0|-0.002|0.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.020|-0.002|0.1180
91677690|NCT00311311|183249717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56||||0.0016|TWO_SIDED|95.0|2.2|8.93||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||8.93|2.20|0.0016
91677691|NCT00311311|183249717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91||||0.0091|TWO_SIDED|95.0|1.01|6.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||6.80|1.01|0.0091
91677692|NCT00311311|183249717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.2468|TWO_SIDED|95.0|-1.6|6.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||6.10|-1.60|0.2468
91677693|NCT00311311|183249718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.5282|TWO_SIDED|95.0|-2.05|3.94||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||3.94|-2.05|0.5282
91677694|NCT00311311|183249718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.5057|TWO_SIDED|95.0|-2.53|5.07||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||5.07|-2.53|0.5057
91677695|NCT00311311|183249718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.5701|TWO_SIDED|95.0|-4.0|7.18||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||7.18|-4.00|0.5701
91677696|NCT00311311|183249720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.028|TWO_SIDED|95.0|0.03|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||12 months post-transplant||0.48|0.03|0.0280
91677697|NCT00311311|183249720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.019|TWO_SIDED|95.0|0.04|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||24 months post-transplant||0.48|0.04|0.0190
91677698|NCT00311311|183249720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.1182|TWO_SIDED|95.0|-0.07|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||36 months post-transplant||0.60|-0.07|0.1182
91677699|NCT00311311|183249721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7361|TWO_SIDED|95.0|-2.09|1.49||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.49|-2.09|0.7361
91677700|NCT00311311|183249721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.5549|TWO_SIDED|95.0|-2.32|1.26||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.26|-2.32|0.5549
91677701|NCT00311311|183249721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.6058|TWO_SIDED|95.0|-3.69|2.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.17|-3.69|0.6058
91677702|NCT00311311|183249722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5902|TWO_SIDED|95.0|-1.63|2.84||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||2.84|-1.63|0.5902
91677703|NCT00311311|183249722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.7536|TWO_SIDED|95.0|-2.68|1.95||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.95|-2.68|0.7536
91677704|NCT00311311|183249722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33||||0.4066|TWO_SIDED|95.0|-4.53|1.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||1.86|-4.53|0.4066
91677705|NCT00311311|183249723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.47||||0.3678|TWO_SIDED|95.0|-11.46|30.4||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.40|-11.46|0.3678
91677706|NCT00311311|183249723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.72||||0.2179|TWO_SIDED|95.0|-6.53|27.97||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||27.97|-6.53|0.2179
91677707|NCT00311311|183249723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.96||||0.3663|TWO_SIDED|95.0|-14.39|38.32||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||38.32|-14.39|0.3663
91677708|NCT00311311|183249724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.041|TWO_SIDED|95.0|0.0|0.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.8|0.0|0.0410
91677709|NCT00311311|183249724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0275|TWO_SIDED|95.0|0.0|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||0.6|0.0|0.0275
91677710|NCT00311311|183249724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1841|TWO_SIDED|95.0|-0.1|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.6|-0.1|0.1841
91527563|NCT01189890|182930415|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.011|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline body weight.||||-0.2|-1.3|0.011
91677711|NCT00311311|183249725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.3||||0.0797|TWO_SIDED|95.0|-108.9|6.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||12 months post-transplant||6.3|-108.9|0.0797
91677712|NCT00311311|183249725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.3||||0.2341|TWO_SIDED|95.0|-88.7|22.2||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||22.2|-88.7|0.2341
91677713|NCT00311311|183249725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2||||0.6854|TWO_SIDED|95.0|-90.3|59.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||59.8|-90.3|0.6854
91692376|NCT02770170|183279666|OTHER|||||||0.6415||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod sigmoidal Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6415
91677714|NCT00311311|183249726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.8||||0.0002|TWO_SIDED|95.0|-108.6|-36.9||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||-36.9|-108.6|0.0002
91677715|NCT00311311|183249726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.6||||0.0017|TWO_SIDED|95.0|-108.5|-26.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||-26.6|-108.5|0.0017
91677716|NCT00311311|183249726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.3||||0.0293|TWO_SIDED|95.0|-118.2|-6.5||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||-6.5|-118.2|0.0293
91677717|NCT00311311|183249728|SUPERIORITY_OR_OTHER|||||||0.2573|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Consent to Conversion||||0.2573
91677718|NCT00311311|183249728|SUPERIORITY_OR_OTHER|||||||0.6386|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Conversion to Month 12||||0.6386
91677719|NCT00311311|183249728|SUPERIORITY_OR_OTHER|||||||0.0709|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 12 to Month 24||||0.0709
91677720|NCT00311311|183249728|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 24 to Month 36||||1.0000
91677721|NCT00311311|183249729|SUPERIORITY_OR_OTHER|||||||0.4286|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Consent to Conversion||||0.4286
91677722|NCT00311311|183249729|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Conversion to Month 12||||1.0000
91677723|NCT00311311|183249729|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 12 to Month 24||||1.0000
91677724|NCT00311311|183249729|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 24 to Month 36||||1.0000
91677725|NCT00311311|183249730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0||||0.2718|TWO_SIDED|95.0|-50.7|14.7||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||14.7|-50.7|0.2718
91677726|NCT00311311|183249730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.2729|TWO_SIDED|95.0|-41.6|12.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||12.1|-41.6|0.2729
91677727|NCT00311311|183249730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.2902|TWO_SIDED|95.0|-23.8|7.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||7.3|-23.8|0.2902
91677728|NCT00507546|183249789|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED|95.0|||||Friedman|||||||0.70
91677729|NCT00507546|183249790|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Friedman|||||||0.35
91677730|NCT03736213|183249794|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.13|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Ultrasound biofeedback treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower normalized acoustic values, a negative difference indicates an advantage for US biofeedback.|||||.13
91677731|NCT00609466|183249795|SUPERIORITY_OR_OTHER||Least square mean|70.8|||<|0.0001||95.0|35.9|105.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||105.6|35.9|<0.0001
91677732|NCT00609466|183249796|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Test for time (in hours) to first rescue medication use. No multiplicity adjustment.|Log Rank|Adjusted for site||||||<0.0001
91677733|NCT00609466|183249797|SUPERIORITY_OR_OTHER||Least square mean|37.5|||<|0.0001||95.0|22.7|52.2||No multiplicity adjustment used|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.2|22.7|<0.0001
91677734|NCT00609466|183249798|SUPERIORITY_OR_OTHER||Least square means|9.9|||<|0.0001||95.0|6.2|13.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||13.6|6.2|<0.0001
91677735|NCT00609466|183249799|SUPERIORITY_OR_OTHER||Least square mean|20.6|||<|0.0001||95.0|13.2|28.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||28.0|13.2|<0.0001
91677736|NCT00609466|183249800|SUPERIORITY_OR_OTHER||Least square mean|36.4|||<|0.0001||95.0|20.7|52.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.0|20.7|<0.0001
91717423|NCT00794664|183327648|SUPERIORITY_OR_OTHER|||||||0.034||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.034
91486831|NCT03924869|182846683|OTHER||Mean Difference (Final Values)|-0.21||||0.9055|TWO_SIDED|95.0|-3.7|3.28|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||3.28|-3.70|0.9055
91486832|NCT01470859|182846684|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.||||||0.84
91486833|NCT01470859|182846684|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1||||||0.93
91486834|NCT01470859|182846684|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5||||||0.31
91677737|NCT00609466|183249801|SUPERIORITY_OR_OTHER||Least square means|108.2||||0.0002||95.0|51.9|164.5||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||164.5|51.9|0.0002
91677738|NCT03512262|183249802|SUPERIORITY||Least Squares (LSM) Means Difference|7.3165|||<|0.0001|TWO_SIDED|99.0|5.0668|9.5663||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||9.5663|5.0668|<0.0001
91677739|NCT03512262|183249803|SUPERIORITY||LSM Difference|2.1209|||<|0.0001|TWO_SIDED|99.0|0.9948|3.2469||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||3.2469|0.9948|<0.0001
91677740|NCT03512262|183249804|SUPERIORITY||LSM Difference|2.8221|||<|0.0001|TWO_SIDED|99.0|1.3972|4.2471||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||4.2471|1.3972|<0.0001
91677741|NCT03188666|183249836|SUPERIORITY||Least Square Mean Difference|-24.6||||0.0741|TWO_SIDED|95.0|-51.8|2.5|||ANCOVA|||||2.5|-51.8|0.0741
91677742|NCT03188666|183249837|SUPERIORITY||Least Square Mean Difference|-24.9||||0.3726|TWO_SIDED|95.0|-80.8|30.9|||Mixed Model with Repeated Measure (MMRM)|||||30.9|-80.8|0.3726
91677743|NCT03188666|183249838|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
91677744|NCT03188666|183249839|SUPERIORITY||Least Square Mean Difference|-25.6||||0.0756|TWO_SIDED|95.0|-53.9|2.8|||ANCOVA|||||2.8|-53.9|0.0756
91677745|NCT03188666|183249840|SUPERIORITY||Least Square Mean Difference|-27.8||||0.3407|TWO_SIDED|95.0|-86.1|30.5|||Mixed Model with Repeated Measure (MMRM)|||||30.5|-86.1|0.3407
91677746|NCT03188666|183249841|SUPERIORITY||Least Square Mean Difference|-0.34||||0.2656|TWO_SIDED|95.0|-0.96|0.27|||ANCOVA|||||0.27|-0.96|0.2656
91677747|NCT03188666|183249842|SUPERIORITY||Least Square Mean Difference|-0.36||||0.2651|TWO_SIDED|95.0|-1.01|0.29|||ANCOVA|||||0.29|-1.01|0.2651
91677748|NCT03188666|183249849|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
91677749|NCT03188666|183249850|SUPERIORITY|||||||0.0027||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0027
91677750|NCT03188666|183249851|SUPERIORITY|||||||0.0047||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0047
91677751|NCT03188666|183249854|SUPERIORITY|||||||0.3663||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.3663
91677752|NCT03188666|183249855|SUPERIORITY|||||||0.001||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.0010
91677753|NCT03188666|183249861|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total new lesion volume per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
91677754|NCT03188666|183249862|SUPERIORITY|||||||0.0273||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total lesion activity per participant in new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0273
91677755|NCT03188666|183249863|SUPERIORITY|||||||0.2123||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.2123
91677756|NCT03188666|183249864|SUPERIORITY|||||||0.1528||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.1528
91677757|NCT05071313|183249904|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.14||||||A/Victoria||1.14|0.89|
91677758|NCT05071313|183249904|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.28||||||A/Tasmania||1.28|0.97|
91677759|NCT05071313|183249904|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.05||||||B/Washington||1.05|0.79|
91677760|NCT05071313|183249904|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.97||||||95.0|0.85|1.1||||||B/Phuket||1.10|0.85|
91486835|NCT01470859|182846685|SUPERIORITY_OR_OTHER|||||||0.691|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups||||||0.691
91486836|NCT01470859|182846685|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups||||||0.706
91677761|NCT03107026|183249955|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.187||0.1187|TWO_SIDED|95.0|-0.66|0.08|||Mixed Models Analysis|||||0.08|-0.66|0.1187
91677762|NCT03107026|183249955|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.192||0.0045|TWO_SIDED|95.0|-0.93|-0.17|||Mixed Models Analysis|||||-0.17|-0.93|0.0045
91677763|NCT03107026|183249956|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.162||0.0256|TWO_SIDED|95.0|-0.68|-0.04|||Mixed Models Analysis|||||-0.04|-0.68|0.0256
91677764|NCT03107026|183249956|SUPERIORITY||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.166||0.0025|TWO_SIDED|95.0|-0.83|-0.18|||Mixed Models Analysis|||||-0.18|-0.83|0.0025
91677765|NCT03107026|183249957|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5342|TWO_SIDED|95.0|0.726|1.854|||Regression, Logistic|||||1.854|0.726|0.5342
91677766|NCT03107026|183249957|SUPERIORITY||Odds Ratio (OR)|1.179||||0.4905|TWO_SIDED|95.0|0.738|1.882|||Regression, Logistic|||||1.882|0.738|0.4905
91677767|NCT03107026|183249958|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.946||0.0154|TWO_SIDED|95.0|-4.16|-0.44|||Mixed Models Analysis|||||-0.44|-4.16|0.0154
91717424|NCT00794664|183327650|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
91717425|NCT00794664|183327652|SUPERIORITY_OR_OTHER||||||<|0.032||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.032
91486837|NCT01470859|182846685|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups||||||0.635
91486838|NCT01470859|182846685|SUPERIORITY_OR_OTHER|||||||0.341|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups||||||0.341
91677768|NCT03107026|183249958|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|0.969||0.0005|TWO_SIDED|95.0|-5.31|-1.5|||Mixed Models Analysis|||||-1.50|-5.31|0.0005
91677769|NCT04763564|183249971|SUPERIORITY||||||<|0.03||||||A priori threshold for significance was \< 0.05. Significance level liraglutide vs. placebo in percent reduction of bowel frequency at week 4 vs. baseline.|Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||<0.03
91677770|NCT04763564|183249974|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||0.01
91486839|NCT01470859|182846685|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups||||||0.049
91486840|NCT01470859|182846685|SUPERIORITY_OR_OTHER|||||||0.874|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups||||||0.874
91677771|NCT00807248|183249998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.96||0.6405|TWO_SIDED|95.0|-2.34|1.44|||ANCOVA|||||1.44|-2.34|0.6405
91677772|NCT00807248|183249998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.96||0.6227|TWO_SIDED|95.0|-1.41|2.35|||ANCOVA|||||2.35|-1.41|0.6227
91677773|NCT00807248|183249999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.98|-3.11|||ANCOVA|||||-3.11|-7.98|<0.0001
91677774|NCT00807248|183249999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.53|-2.66|||ANCOVA|||||-2.66|-7.53|<0.0001
91677775|NCT00807248|183249999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-8.43|-3.56|||ANCOVA|||||-3.56|-8.43|<0.0001
91677776|NCT00807248|183250000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.98|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.13|-2.84|||ANCOVA|||||-2.84|-7.13|<0.0001
91677777|NCT00807248|183250000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-6.6|-2.32|||ANCOVA|||||-2.32|-6.60|<0.0001
91677778|NCT00807248|183250000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.27|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.41|-3.13|||ANCOVA|||||-3.13|-7.41|<0.0001
91677779|NCT00807248|183250001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58|||ANCOVA|||||-1.58|-4.59|<0.0001
91677780|NCT00807248|183250001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.15|-1.14|||ANCOVA|||||-1.14|-4.15|0.0006
91717426|NCT00794664|183327654|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||<0.001
91717427|NCT00794664|183327656|SUPERIORITY_OR_OTHER|||||||0.278||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.278
91717428|NCT00794664|183327658|SUPERIORITY_OR_OTHER|||||||0.647||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.647
91486841|NCT01470859|182846686|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1||||||0.720
91677781|NCT00807248|183250001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-5.13|-2.1|||ANCOVA|||||-2.10|-5.13|<0.0001
91677782|NCT00807248|183250002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.85|-0.64|||ANCOVA|||||-0.64|-1.85|<0.0001
91677783|NCT00807248|183250002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.72|-0.5|||ANCOVA|||||-0.50|-1.72|0.0004
91677784|NCT00807248|183250002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.87|-0.65|||ANCOVA|||||-0.65|-1.87|<0.0001
91677785|NCT00807248|183250003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.72|-0.46|||ANCOVA|||||-0.46|-1.72|0.0007
91677786|NCT00807248|183250003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.33||0.0013|TWO_SIDED|95.0|-1.69|-0.41|||ANCOVA|||||-0.41|-1.69|0.0013
91677787|NCT00807248|183250003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.92|-0.66|||ANCOVA|||||-0.66|-1.92|<0.0001
91677788|NCT00807248|183250004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.31||0.0002|TWO_SIDED|95.0|-1.82|-0.58|||ANCOVA|||||-0.58|-1.82|0.0002
91677789|NCT00807248|183250004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.32||0.0006|TWO_SIDED|95.0|-1.72|-0.48|||ANCOVA|||||-0.48|-1.72|0.0006
91677790|NCT00807248|183250004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.0|-0.76|||ANCOVA|||||-0.76|-2.00|<0.0001
91677791|NCT00807248|183250005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.34|||ANCOVA|||||-0.34|-0.89|<0.0001
91677792|NCT00807248|183250005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.82|-0.26|||ANCOVA|||||-0.26|-0.82|0.0001
91677793|NCT00807248|183250005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||||-0.44|-0.99|<0.0001
91677794|NCT00807248|183250006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5|||ANCOVA|||||-0.50|-1.02|<0.0001
91677795|NCT00807248|183250006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.88|-0.36|||ANCOVA|||||-0.36|-0.88|<0.0001
91677796|NCT00807248|183250006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.97|-0.45|||ANCOVA|||||-0.45|-0.97|<0.0001
91677797|NCT02504671|183250054|OTHER||Odds Ratio (OR)|2.12||||0.547|TWO_SIDED|95.0|0.18|24.52|||Regression, Logistic||95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.|||24.52|0.18|0.547
91677798|NCT02504671|183250054|OTHER||Odds Ratio (OR)|7.11||||0.077|TWO_SIDED|95.0|0.81|62.44|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.44|0.81|0.077
91677799|NCT02504671|183250054|OTHER||Odds Ratio (OR)|8.39||||0.053|TWO_SIDED|95.0|0.98|72.14|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||72.14|0.98|0.053
91677800|NCT02504671|183250054|OTHER||Odds Ratio (OR)|5.69||||0.122|TWO_SIDED|95.0|0.63|51.4|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.40|0.63|0.122
91677801|NCT02504671|183250054|OTHER||Odds Ratio (OR)|5.4||||0.134|TWO_SIDED|95.0|0.6|48.83|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.83|0.60|0.134
91677802|NCT02504671|183250055|OTHER||Mean Difference (Net)|0.46||||0.905|TWO_SIDED|95.0|-7.13|8.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|Mixed Model Repeated Measures (MMRM)||CRP, Week 12|||8.05|-7.13|0.905
91677803|NCT02504671|183250055|OTHER||Mean Difference (Net)|-3.36||||0.387|TWO_SIDED|95.0|-11.0|4.28||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.28|-11.00|0.387
91677804|NCT02504671|183250055|OTHER||Mean Difference (Net)|-2.58||||0.495|TWO_SIDED|95.0|-10.04|4.87||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.87|-10.04|0.495
91677805|NCT02504671|183250055|OTHER||Mean Difference (Net)|-7.68||||0.14|TWO_SIDED|95.0|-17.92|2.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||2.55|-17.92|0.140
91677806|NCT02504671|183250055|OTHER||Mean Difference (Net)|-13.68||||0.009|TWO_SIDED|95.0|-23.85|-3.52||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-3.52|-23.85|0.009
91677807|NCT02504671|183250055|OTHER||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-27.44|-7.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.35|-27.44|<0.001
91677808|NCT02504671|183250055|OTHER||Mean Difference (Net)|-2.42||||0.118|TWO_SIDED|95.0|-5.45|0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.62|-5.45|0.118
91677809|NCT02504671|183250055|OTHER||Mean Difference (Net)|-3.17||||0.041|TWO_SIDED|95.0|-6.2|-0.14||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-0.14|-6.20|0.041
91717429|NCT00720499|183327668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.017||0.8937|TWO_SIDED|95.0|-0.035|0.031|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.031|-0.035|0.8937
91717430|NCT00720499|183327669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.019||0.2425|TWO_SIDED|95.0|-0.015|0.061|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.061|-0.015|0.2425
91717431|NCT00720499|183327671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.008||0.5198|TWO_SIDED|95.0|-0.01|0.021|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.021|-0.010|0.5198
91717432|NCT00720499|183327671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.211|TWO_SIDED|95.0|-0.011|0.051|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.051|-0.011|0.2110
91717433|NCT00720499|183327671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.014||0.9368|TWO_SIDED|95.0|-0.029|0.027|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.027|-0.029|0.9368
91717434|NCT00720499|183327672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.5339|TWO_SIDED|95.0|-0.027|0.014|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.014|-0.027|0.5339
91717435|NCT00720499|183327672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.019||0.2408|TWO_SIDED|95.0|-0.015|0.058|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.058|-0.015|0.2408
91717436|NCT00720499|183327672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.018||0.7139|TWO_SIDED|95.0|-0.029|0.042|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.042|-0.029|0.7139
91717437|NCT00720499|183327673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.015||0.7906|TWO_SIDED|95.0|-0.026|0.034|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.034|-0.026|0.7906
91717438|NCT00720499|183327674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.038||0.8473|TWO_SIDED|95.0|-0.067|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.067|0.8473
91717439|NCT00720499|183327675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.031||0.2944|TWO_SIDED|95.0|-0.029|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.029|0.2944
91717440|NCT00720499|183327675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||0.718|TWO_SIDED|95.0|-0.046|0.066|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.066|-0.046|0.7180
91717441|NCT00720499|183327677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.015||0.9384|TWO_SIDED|95.0|-0.029|0.032|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.032|-0.029|0.9384
91717442|NCT00720499|183327677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1583|TWO_SIDED|95.0|-0.014|0.088|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.088|-0.014|0.1583
91717443|NCT00720499|183327677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.027||0.2914|TWO_SIDED|95.0|-0.025|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.025|0.2914
91717444|NCT00720499|183327678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03||0.2485|TWO_SIDED|95.0|-0.024|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.024|0.2485
91717445|NCT00720499|183327679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.043||0.2875|TWO_SIDED|95.0|-0.039|0.13|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.130|-0.039|0.2875
91717446|NCT00720499|183327680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.984|STANDARD_ERROR_OF_MEAN|2.038||0.6299|TWO_SIDED|95.0|-3.046|5.015|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.015|-3.046|0.6299
91717447|NCT00720499|183327680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.311|STANDARD_ERROR_OF_MEAN|3.156||0.0475|TWO_SIDED|95.0|0.07|12.553|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||12.553|0.070|0.0475
91717448|NCT00720499|183327680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.552|STANDARD_ERROR_OF_MEAN|2.67||0.562|TWO_SIDED|95.0|-3.729|6.833|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.833|-3.729|0.5620
91717449|NCT00720499|183327681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|STANDARD_ERROR_OF_MEAN|2.342||0.9391|TWO_SIDED|95.0|-4.812|4.454|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||4.454|-4.812|0.9391
91717450|NCT00720499|183327681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48|STANDARD_ERROR_OF_MEAN|3.559||0.0709|TWO_SIDED|95.0|-0.56|13.52|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||13.520|-0.560|0.0709
91717451|NCT00720499|183327681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.099|STANDARD_ERROR_OF_MEAN|3.134||0.3245|TWO_SIDED|95.0|-3.1|9.298|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||9.298|-3.100|0.3245
91717452|NCT00720499|183327682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|4.655||0.8808|TWO_SIDED|95.0|-9.914|8.514|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.514|-9.914|0.8808
91717453|NCT00720499|183327683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.119|STANDARD_ERROR_OF_MEAN|2.177||0.6081|TWO_SIDED|95.0|-3.19|5.429|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.429|-3.190|0.6081
91717454|NCT00720499|183327683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.339|STANDARD_ERROR_OF_MEAN|2.342||0.5686|TWO_SIDED|95.0|-3.296|5.973|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.973|-3.296|0.5686
91717455|NCT00720499|183327683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.653|STANDARD_ERROR_OF_MEAN|2.294||0.7765|TWO_SIDED|95.0|-3.888|5.194|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.194|-3.888|0.7765
91717456|NCT00720499|183327683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.654|STANDARD_ERROR_OF_MEAN|2.543||0.5166|TWO_SIDED|95.0|-3.379|6.686|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.686|-3.379|0.5166
91717457|NCT00720499|183327684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.303|STANDARD_ERROR_OF_MEAN|2.585||0.2037|TWO_SIDED|95.0|-1.813|8.418|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.418|-1.813|0.2037
91717458|NCT00720499|183327684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.393|STANDARD_ERROR_OF_MEAN|2.738||0.6118|TWO_SIDED|95.0|-4.027|6.813|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.813|-4.027|0.6118
91717459|NCT00720499|183327684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.695|STANDARD_ERROR_OF_MEAN|2.498||0.4988|TWO_SIDED|95.0|-3.251|6.64|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.640|-3.251|0.4988
91717460|NCT00720499|183327684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.039|STANDARD_ERROR_OF_MEAN|2.478||0.6757|TWO_SIDED|95.0|-5.944|3.865|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||3.865|-5.944|0.6757
91717461|NCT00720499|183327685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.08||0.8901|TWO_SIDED|95.0|-0.147|0.169|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.169|-0.147|0.8901
91717462|NCT00720499|183327685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.1647|TWO_SIDED|95.0|-0.29|0.05|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.050|-0.290|0.1647
91717463|NCT00720499|183327685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.09||0.9822|TWO_SIDED|95.0|-0.18|0.176|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.176|-0.180|0.9822
91717464|NCT00720499|183327685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6542|TWO_SIDED|95.0|-0.218|0.137|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.137|-0.218|0.6542
91717465|NCT00720499|183327686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.116||0.3269|TWO_SIDED|95.0|-0.342|0.115|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for treatment, centre, patient within centre and period (all effects fixed).||0.115|-0.342|0.3269
91717466|NCT00720499|183327687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.089||0.9557|TWO_SIDED|95.0|-0.181|0.171|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.171|-0.181|0.9557
91717467|NCT00720499|183327687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.08||0.8096|TWO_SIDED|95.0|-0.178|0.14|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.140|-0.178|0.8096
91717468|NCT00492726|183327705|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.|Difference of cure rates (in percent)|-3.8||||||95.0|-7.9|0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||0.4|-7.9|
91717469|NCT00492726|183327706|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in improvement rates (in %)|1.1||||||95.0|-0.4|2.7|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||2.7|-0.4|
91717470|NCT00492726|183327707|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
91677810|NCT02504671|183250055|OTHER||Mean Difference (Net)|-4.56||||0.003|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.003
91677811|NCT02504671|183250055|OTHER||Mean Difference (Net)|-2.3||||0.172|TWO_SIDED|95.0|-5.61|1.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TC28, Week 12|||1.01|-5.61|0.172
91677812|NCT02504671|183250055|OTHER||Mean Difference (Net)|-3.92||||0.02|TWO_SIDED|95.0|-7.22|-0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.62|-7.22|0.020
91677813|NCT02504671|183250055|OTHER||Mean Difference (Net)|-5.72|||<|0.001|TWO_SIDED|95.0|-8.98|-2.45||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-2.45|-8.98|<0.001
91677814|NCT02504671|183250055|OTHER||Mean Difference (Net)|-2.51||||0.518|TWO_SIDED|95.0|-10.13|5.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.12|-10.13|0.518
91677815|NCT02504671|183250055|OTHER||Mean Difference (Net)|-2.0||||0.599|TWO_SIDED|95.0|-9.5|5.49||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.49|-9.50|0.599
91677816|NCT02504671|183250055|OTHER||Mean Difference (Net)|-12.63||||0.015|TWO_SIDED|95.0|-22.78|-2.48||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-2.48|-22.78|0.015
91677817|NCT02504671|183250055|OTHER||Mean Difference (Net)|-17.18|||<|0.001|TWO_SIDED|95.0|-27.27|-7.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.10|-27.27|<0.001
91677818|NCT02504671|183250055|OTHER||Mean Difference (Net)|-2.98||||0.054|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.054
91677819|NCT02504671|183250055|OTHER||Mean Difference (Net)|-6.04|||<|0.001|TWO_SIDED|95.0|-9.05|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-3.02|-9.05|<0.001
91677820|NCT02504671|183250055|OTHER||Mean Difference (Net)|-3.63||||0.031|TWO_SIDED|95.0|-6.92|-0.33||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.33|-6.92|0.031
91677821|NCT02504671|183250055|OTHER||Mean Difference (Net)|-6.32|||<|0.001|TWO_SIDED|95.0|-9.61|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-3.02|-9.61|<0.001
91677822|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91677823|NCT02504671|183250056|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
91677824|NCT02504671|183250056|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-12.7|1.9|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||1.9|-12.7|
91486842|NCT01470859|182846686|SUPERIORITY_OR_OTHER|||||||0.867|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5||||||0.867
91677825|NCT02504671|183250056|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
91677826|NCT02504671|183250056|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91677827|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677828|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677829|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677830|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677831|NCT02504671|183250056|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
91677832|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91677833|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91677834|NCT02504671|183250056|OTHER||Difference|27.0|||||TWO_SIDED|95.0|12.7|41.3|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.3|12.7|
91677835|NCT02504671|183250056|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91677836|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677837|NCT02504671|183250056|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677838|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677839|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677840|NCT02504671|183250056|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677841|NCT02504671|183250056|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91677842|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677843|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677844|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677845|NCT02504671|183250056|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91677846|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677847|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677848|NCT02504671|183250056|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677849|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677850|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91677851|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91677852|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91677853|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677854|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677855|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677856|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91677857|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91677858|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91677859|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677860|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677861|NCT02504671|183250056|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91677862|NCT02504671|183250056|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91677863|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677864|NCT02504671|183250056|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91677865|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91677866|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91677867|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91717471|NCT00492726|183327708|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-1.5||||||95.0|-5.0|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-5.0|
91486843|NCT01470859|182846687|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|indenpendent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole group at V1||||||0.793
91486844|NCT01470859|182846687|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole groups at V5||||||0.430
91486845|NCT01470859|182846688|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2||||||0.345
91486846|NCT01470859|182846688|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5||||||0.410
91486847|NCT03708770|182846707|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis."|The Secondary Patency rate was determined via Kaplan-Meier methods.|||
91677868|NCT02504671|183250056|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
91677869|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
91677870|NCT02504671|183250056|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677871|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677872|NCT02504671|183250056|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91677873|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677874|NCT02504671|183250056|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91677875|NCT02504671|183250056|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91677876|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677877|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677878|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677879|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677880|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677881|NCT02504671|183250056|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91677882|NCT02504671|183250056|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91677883|NCT02504671|183250056|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677884|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677885|NCT02504671|183250056|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677886|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91677887|NCT02504671|183250056|OTHER||Difference|24.3|||||TWO_SIDED|95.0|10.5|38.1|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.1|10.5|
91677888|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677889|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677890|NCT02504671|183250056|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91677891|NCT02504671|183250056|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91677892|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677893|NCT02504671|183250056|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91677894|NCT02504671|183250056|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91677895|NCT02504671|183250056|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677896|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.32||||0.046|TWO_SIDED|95.0|-0.64|-0.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.01|-0.64|0.046
91486848|NCT03708770|182846708|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis."|The primary patency rate was determined via Kaplan-Meier methods.|||
91677897|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.3||||0.071|TWO_SIDED|95.0|-0.62|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||0.03|-0.62|0.071
91677898|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.37||||0.022|TWO_SIDED|95.0|-0.69|-0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.05|-0.69|0.022
91677899|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.28||||0.16|TWO_SIDED|95.0|-0.67|0.11||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.11|-0.67|0.160
91677900|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.32||||0.103|TWO_SIDED|95.0|-0.71|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.07|-0.71|0.103
91677901|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.42||||0.034|TWO_SIDED|95.0|-0.8|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.03|-0.80|0.034
91677902|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.4||||0.096|TWO_SIDED|95.0|-0.87|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||0.07|-0.87|0.096
91677903|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.56||||0.02|TWO_SIDED|95.0|-1.02|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.09|-1.02|0.020
91677904|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.76||||0.001|TWO_SIDED|95.0|-1.22|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.29|-1.22|0.001
91677905|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.42||||0.11|TWO_SIDED|95.0|-0.93|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.10|-0.93|0.110
91677906|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.47||||0.076|TWO_SIDED|95.0|-0.98|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.05|-0.98|0.076
91677907|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.61||||0.02|TWO_SIDED|95.0|-1.11|-0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.10|-1.11|0.020
91677908|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.42||||0.128|TWO_SIDED|95.0|-0.97|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||0.12|-0.97|0.128
91677909|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.78||||0.005|TWO_SIDED|95.0|-1.33|-0.24||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.24|-1.33|0.005
91677910|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.82||||0.003|TWO_SIDED|95.0|-1.36|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.29|-1.36|0.003
91677911|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.53||||0.11|TWO_SIDED|95.0|-1.17|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||0.12|-1.17|0.110
91677912|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.88||||0.008|TWO_SIDED|95.0|-1.53|-0.23||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.23|-1.53|0.008
91677913|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.24|||<|0.001|TWO_SIDED|95.0|-1.88|-0.6||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.60|-1.88|<0.001
91677914|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.29||||0.5|TWO_SIDED|95.0|-1.15|0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.56|-1.15|0.500
91677915|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.99||||0.021|TWO_SIDED|95.0|-1.83|-0.15||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.15|-1.83|0.021
91677916|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.0||||0.017|TWO_SIDED|95.0|-1.83|-0.18||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.18|-1.83|0.017
91677917|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.07||||0.871|TWO_SIDED|95.0|-0.98|0.83||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.83|-0.98|0.871
91677918|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.58||||0.19|TWO_SIDED|95.0|-1.46|0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.29|-1.46|0.190
91677919|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.66||||0.13|TWO_SIDED|95.0|-1.51|0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.20|-1.51|0.130
91677920|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.22||||0.019|TWO_SIDED|95.0|-2.24|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.20|-2.24|0.019
91677921|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.53||||0.002|TWO_SIDED|95.0|-2.51|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.55|-2.51|0.002
91677922|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.39||||0.005|TWO_SIDED|95.0|-2.34|-0.43||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.43|-2.34|0.005
91677923|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.41||||0.013|TWO_SIDED|95.0|-0.73|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.09|-0.73|0.013
91677924|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.49||||0.003|TWO_SIDED|95.0|-0.8|-0.17||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.17|-0.80|0.003
91677925|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.47||||0.017|TWO_SIDED|95.0|-0.86|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.09|-0.86|0.017
91677926|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.52||||0.009|TWO_SIDED|95.0|-0.9|-0.13||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.13|-0.90|0.009
91677927|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.67||||0.005|TWO_SIDED|95.0|-1.13|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.20|-1.13|0.005
91677928|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.48|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.55|-1.48|<0.001
91677929|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.47||||0.073|TWO_SIDED|95.0|-0.99|0.04||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.04|-0.99|0.073
91677930|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.85||||0.001|TWO_SIDED|95.0|-1.36|-0.34||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.34|-1.36|0.001
91677931|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.89||||0.001|TWO_SIDED|95.0|-1.43|-0.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.35|-1.43|0.001
91677932|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.65|-0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.56|-1.65|<0.001
91677933|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.68||||0.039|TWO_SIDED|95.0|-1.32|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.03|-1.32|0.039
91677934|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.91|-0.63||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.63|-1.91|<0.001
91677935|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.77||||0.073|TWO_SIDED|95.0|-1.61|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.07|-1.61|0.073
91677936|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.11||||0.007|TWO_SIDED|95.0|-1.91|-0.3||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.30|-1.91|0.007
91677937|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.77||||0.083|TWO_SIDED|95.0|-1.65|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.10|-1.65|0.083
91677938|NCT02504671|183250057|OTHER||Mean Difference (Net)|-0.8||||0.059|TWO_SIDED|95.0|-1.63|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.03|-1.63|0.059
91677939|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.48||||0.003|TWO_SIDED|95.0|-2.46|-0.5||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.50|-2.46|0.003
91486849|NCT05268055|182846712|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||Group comparison of all participants.||||0.525
91677940|NCT02504671|183250057|OTHER||Mean Difference (Net)|-1.82|||<|0.001|TWO_SIDED|95.0|-2.75|-0.89||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.89|-2.75|<0.001
91677941|NCT02504671|183250059|OTHER||Difference|16.2||||0.037|TWO_SIDED|95.0|1.1|31.4|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.4|1.1|0.037
91677942|NCT02504671|183250059|OTHER||Difference|10.8||||0.144|TWO_SIDED|95.0|-3.1|24.7|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|0.144
91677943|NCT02504671|183250059|OTHER||Difference|18.9||||0.033|TWO_SIDED|95.0|3.3|34.5|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|0.033
91677944|NCT02504671|183250059|OTHER||Difference|5.4||||0.437|TWO_SIDED|95.0|-11.3|22.2|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||22.2|-11.3|0.437
91677945|NCT02504671|183250059|OTHER||Difference|2.7||||0.755|TWO_SIDED|95.0|-13.5|18.9|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||18.9|-13.5|0.755
91677946|NCT02504671|183250059|OTHER||Difference|24.3||||0.023|TWO_SIDED|95.0|5.2|43.4|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|0.023
91677947|NCT02504671|183250059|OTHER||Difference|29.7||||0.006|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.006
91677948|NCT02504671|183250059|OTHER||Difference|21.6||||0.039|TWO_SIDED|95.0|2.0|41.2|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|0.039
91677949|NCT02504671|183250059|OTHER||Difference|29.7||||0.008|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.008
91677950|NCT02504671|183250059|OTHER||Difference|21.6||||0.044|TWO_SIDED|95.0|0.4|42.8|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|0.044
91677951|NCT02504671|183250059|OTHER||Difference|18.9||||0.083|TWO_SIDED|95.0|-2.2|40.0|||Regression, Logistic||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||40.0|-2.2|0.083
91677952|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.8|48.3|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.3|5.8|
91677953|NCT02504671|183250059|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-11.2|32.8|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.Wald confidence limits without correction.|||32.8|-11.2|
91677954|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
91677955|NCT02504671|183250059|OTHER||Difference|32.4|||||TWO_SIDED|95.0|10.9|54.0|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||54.0|10.9|
91677956|NCT02504671|183250059|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
91677957|NCT02504671|183250059|OTHER||Difference|29.7|||||TWO_SIDED|95.0|8.9|50.6|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||50.6|8.9|
91677958|NCT02504671|183250059|OTHER||Difference|45.9|||||TWO_SIDED|95.0|25.9|66.0|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||66.0|25.9|
91677959|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
91677960|NCT02504671|183250059|OTHER||Difference|32.4|||||TWO_SIDED|95.0|11.6|53.3|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||53.3|11.6|
91677961|NCT02504671|183250059|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.2|58.5|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||58.5|17.2|
91677962|NCT02504671|183250059|OTHER||Difference|18.9|||||TWO_SIDED|95.0|-0.5|38.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.4|-0.5|
91677963|NCT02504671|183250059|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
91526755|NCT02395133|182928903|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|27.42|51.95||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||51.95|27.42|<0.0001
91527564|NCT00077636|182930416|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.76|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.76|0.46|<.0001
91677964|NCT02504671|183250059|OTHER||Difference|48.6|||||TWO_SIDED|95.0|29.2|68.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.1|29.2|
91677965|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-3.0|35.4|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.4|-3.0|
91677966|NCT02504671|183250059|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
91677967|NCT02504671|183250059|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
91677968|NCT02504671|183250059|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677969|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677970|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677971|NCT02504671|183250059|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677972|NCT02504671|183250059|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91677973|NCT02504671|183250059|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91677974|NCT02504671|183250059|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677975|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677976|NCT02504671|183250059|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91677977|NCT02504671|183250059|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677978|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677979|NCT02504671|183250059|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91677980|NCT02504671|183250059|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677981|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677982|NCT02504671|183250059|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91677983|NCT02504671|183250059|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91677984|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677985|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677986|NCT02504671|183250059|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91677987|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677988|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91677989|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91486850|NCT05268055|182846712|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.045
91717472|NCT00492726|183327709|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
91717473|NCT00492726|183327710|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.8||||||95.0|-9.0|1.5|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.5|-9.0|
91717474|NCT00492726|183327711|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-2.9||||||95.0|-7.6|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-7.6|
91717475|NCT01100502|183327715|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.001|TWO_SIDED|95.0|0.4|0.81|||Log Rank|||||0.81|0.40|0.001
91717476|NCT01621009|183327727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||>|0.05|TWO_SIDED|95.0|0.78|3.36|||Regression, Logistic|||||3.36|.78|>0.05
91717477|NCT01621009|183327727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.52|2.44|||Regression, Logistic|||||2.44|.52|>0.05
91717478|NCT04356937|183327740|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.64|TWO_SIDED|95.0|0.38|1.81|||Log Rank|||||1.81|0.38|0.64
91717479|NCT04356937|183327741|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.73|TWO_SIDED|95.0|0.59|2.1|||Log Rank|||||2.10|0.59|0.73
91717480|NCT04356937|183327742|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.69|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.69
91717481|NCT02557399|183327764|SUPERIORITY_OR_OTHER||difference in percent|-6.83||||0.008|TWO_SIDED|95.0|-11.88|-1.78||The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.78|-11.88|0.008
91717482|NCT02557399|183327765|SUPERIORITY_OR_OTHER||difference in percent|-0.25||||0.916|TWO_SIDED|95.0|-4.85|4.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1|||4.35|-4.85|0.916
91717483|NCT02557399|183327765|SUPERIORITY_OR_OTHER||difference in percent|-5.85||||0.01|TWO_SIDED|95.0|-10.29|-1.42||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4|||-1.42|-10.29|0.010
91717484|NCT02557399|183327765|SUPERIORITY_OR_OTHER||difference in percent|-2.35||||0.257|TWO_SIDED|95.0|-6.42|1.72||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8|||1.72|-6.42|0.257
91486851|NCT05268055|182846712|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.046
91717485|NCT02557399|183327765|SUPERIORITY_OR_OTHER||difference in percent|-3.24||||0.062|TWO_SIDED|95.0|-6.64|0.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12|||0.16|-6.64|0.062
91486852|NCT05268055|182846713|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Group comparison of all participants.||||0.200
91486853|NCT05268055|182846713|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.075
91486854|NCT05268055|182846713|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.015
91486855|NCT05268055|182846714|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Group comparison of all participants.||||0.246
91486856|NCT05268055|182846714|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.151
91486857|NCT05268055|182846714|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.033
91486858|NCT05268055|182846715|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Group comparison of all participants.||||0.212
91486859|NCT05268055|182846715|SUPERIORITY|||||||0.893|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.893
91486860|NCT05268055|182846715|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.160
91486861|NCT05268055|182846716|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Healthcare Provider Cultural Competence measure.||||0.752
91486862|NCT05268055|182846716|SUPERIORITY|||||||0.493|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Ask, Understand, Remember Assessment.||||0.493
91486863|NCT05268055|182846716|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Wake Forest Physician Trust Scale.||||0.085
91486864|NCT03507400|182846717|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91486865|NCT03507400|182846717|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||pooled comparison of the participants of the non-waiting list and the waiting list before and after Introvision||||0.003
91486866|NCT03507400|182846719|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91486867|NCT03507400|182846720|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.003
91717486|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-5.08||||0.115|TWO_SIDED|95.0|-11.41|1.25||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.25|-11.41|0.115
91717487|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-8.43||||0.005|TWO_SIDED|95.0|-14.35|-2.51||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.51|-14.35|0.005
91717488|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-9.37|||<|0.001|TWO_SIDED|95.0|-14.42|-4.33||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-4.33|-14.42|<0.001
91717489|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-6.69||||0.004|TWO_SIDED|95.0|-11.21|-2.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.16|-11.21|0.004
91717490|NCT02557399|183327766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.015|TWO_SIDED|95.0|-8.1|-0.89||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs|||-0.89|-8.10|0.015
91717491|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|2.71||||0.382|TWO_SIDED|95.0|-3.38|8.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||8.80|-3.38|0.382
91717492|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-5.69||||0.085|TWO_SIDED|95.0|-12.17|0.78||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.78|-12.17|0.085
91717493|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-3.89||||0.186|TWO_SIDED|95.0|-9.67|1.88||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.88|-9.67|0.186
91717494|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-0.59||||0.818|TWO_SIDED|95.0|-5.61|4.44||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.44|-5.61|0.818
91717495|NCT02557399|183327766|SUPERIORITY_OR_OTHER||difference in percent|-3.78||||0.073|TWO_SIDED|95.0|-7.92|0.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.35|-7.92|0.073
91526756|NCT02395133|182928904|SUPERIORITY||Percentage difference|-14.4||||0.1048|TWO_SIDED|95.0|-29.21|0.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||0.32|-29.21|0.1048
91526757|NCT02395133|182928904|SUPERIORITY||Percentage difference|-20.6|||=|0.0107|TWO_SIDED|95.0|-35.32|-5.89||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-5.89|-35.32|= 0.0107
91526758|NCT02395133|182928904|SUPERIORITY||Percentage difference|-36.1|||<|0.0001|TWO_SIDED|95.0|-48.4|-23.74||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-23.74|-48.40|<0.0001
91717496|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.961|TWO_SIDED|95.0|-4.6|4.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.4|-4.6|0.961
91717497|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.2||||0.015|TWO_SIDED|95.0|-11.2|-1.2||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.2|-11.2|0.015
91486868|NCT03507400|182846721|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
91677990|NCT02504671|183250059|OTHER||Difference|21.6|||||TWO_SIDED|95.0|5.6|37.7|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.7|5.6|
91677991|NCT02504671|183250059|OTHER||Difference|18.9|||||TWO_SIDED|95.0|0.2|37.6|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.6|0.2|
91677992|NCT02504671|183250059|OTHER||Difference|24.3|||||TWO_SIDED|95.0|5.2|43.4|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|
91677993|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
91677994|NCT02504671|183250059|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
91677995|NCT02504671|183250059|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
91677996|NCT02504671|183250059|OTHER||Difference|40.5|||||TWO_SIDED|95.0|19.9|61.2|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||61.2|19.9|
91677997|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
91677998|NCT02504671|183250059|OTHER||Difference|35.1|||||TWO_SIDED|95.0|13.8|56.5|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.5|13.8|
91677999|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|6.2|47.9|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||47.9|6.2|
91678000|NCT02504671|183250059|OTHER||Difference|54.1|||||TWO_SIDED|95.0|34.9|73.2|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.2|34.9|
91678001|NCT02504671|183250059|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
91678002|NCT02504671|183250059|OTHER||Difference|51.4|||||TWO_SIDED|95.0|31.8|70.9|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|31.8|
91678003|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
91486869|NCT03507400|182846722|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
91678004|NCT02504671|183250059|OTHER||Difference|56.8|||||TWO_SIDED|95.0|38.2|75.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||75.4|38.2|
91678005|NCT02504671|183250059|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
91678006|NCT02504671|183250059|OTHER||Difference|54.1|||||TWO_SIDED|95.0|35.1|73.0|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.0|35.1|
91678007|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678008|NCT02504671|183250059|OTHER||Difference|75.7|||||TWO_SIDED|95.0|61.4|89.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||89.9|61.4|
91678009|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678010|NCT02504671|183250059|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
91678011|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678012|NCT02504671|183250059|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
91678013|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678014|NCT02504671|183250059|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
91678015|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678016|NCT02504671|183250059|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
91678017|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91486870|NCT03507400|182846726|SUPERIORITY|Wilcoxon paired test||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91486871|NCT03507400|182846726|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91486872|NCT03507400|182846726|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91486873|NCT01555983|182846727|SUPERIORITY_OR_OTHER||Cochran-Armitage trend tes|0.0001|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.||||<.05
91526759|NCT00510458|182928934|OTHER|It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).|mean linear wear rate at 5 yrs|0.008|||||TWO_SIDED|90.0|-0.0107|0.0267||||||||.0267|-0.0107|
91678018|NCT02504671|183250059|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
91678019|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678020|NCT02504671|183250059|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
91678021|NCT02504671|183250059|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678022|NCT02504671|183250059|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
91678023|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678024|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91717498|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.044|TWO_SIDED|95.0|-9.2|-0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.1|-9.2|0.044
91486874|NCT04026711|182846734|SUPERIORITY|||||||0.81|||||||Wilcoxon rank sum|||||||0.81
91486875|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.79|||||TWO_SIDED|95.0|-0.16|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.95|-0.16|
91486876|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.606|||||TWO_SIDED|95.0|-0.1|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.91|-0.10|
91486877|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.637|||||TWO_SIDED|95.0|-0.05|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.92|-0.05|
91526760|NCT00510458|182928935|OTHER|To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91678025|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91486878|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.741|||||TWO_SIDED|95.0|0.33|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.91|0.33|
91486879|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.88|||||TWO_SIDED|95.0|0.65|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.96|0.65|
91526761|NCT00510458|182928936|OTHER|To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91526762|NCT00510458|182928937|OTHER|To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91678026|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 1, ACR50. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678027|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91678028|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
91678029|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
91678030|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678031|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678032|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678033|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
91678034|NCT02504671|183250060|OTHER||Difference|27.0|||||TWO_SIDED|95.0|9.3|44.7|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.7|9.3|
91678035|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
91678036|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
91678037|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
91678038|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
91678039|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4, ACR70. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678040|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
91678041|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-11.7|27.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||27.9|-11.7|
91678042|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
91678043|NCT02504671|183250060|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-17.8|7.0|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.0|-17.8|
91678044|NCT02504671|183250060|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-16.0|10.6|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.6|-16.0|
91678045|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
91678046|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678047|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678048|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
91678049|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
91678050|NCT02504671|183250060|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
91678051|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678052|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678053|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678054|NCT02504671|183250060|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678055|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678056|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678057|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.0|42.7|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|6.0|
91678058|NCT02504671|183250060|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
91678059|NCT02504671|183250060|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
91678060|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
91678061|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
91678062|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
91678063|NCT02504671|183250060|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
91678064|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
91678065|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91678066|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-5.4|32.4|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.4|-5.4|
91678067|NCT02504671|183250060|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
91678068|NCT02504671|183250060|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
91678069|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
91678070|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
91678071|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
91678072|NCT02504671|183250060|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
91678073|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
91678074|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91678075|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
91678076|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
91678077|NCT02504671|183250060|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
91678078|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
91678079|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
91678080|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
91678081|NCT02504671|183250060|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
91678082|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
91678083|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
91678084|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-6.9|28.5|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.5|-6.9|
91678085|NCT02504671|183250060|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
91678086|NCT02504671|183250060|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.8|62.6|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.6|23.8|
91678087|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
91678088|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
91678089|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|1.1|36.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.7|1.1|
91678090|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
91678091|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
91678092|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
91678093|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678094|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678095|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678096|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678097|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678098|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678099|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678100|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678101|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678102|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678103|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91678104|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91678105|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678106|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91678107|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678108|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91678109|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678110|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678111|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678112|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678113|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678114|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91678115|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678116|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678117|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678118|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91678119|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678120|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678121|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678122|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
91678123|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678124|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678125|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678126|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91678127|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678128|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678129|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678130|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678131|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678132|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678133|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678134|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678135|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678136|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91678137|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678138|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678139|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678140|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678141|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678142|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678143|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91486880|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.892|||||TWO_SIDED|95.0|-0.16|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.98|-0.16|
91486881|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.77|||||TWO_SIDED|95.0|0.36|0.93|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.93|0.36|
91486882|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.715|||||TWO_SIDED|95.0|-0.08|0.94|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.94|-0.08|
91486883|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.767|||||TWO_SIDED|95.0|-0.04|0.96|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.96|-0.04|
91486884|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.428|||||TWO_SIDED|95.0|-0.17|0.84|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.84|-0.17|
91486885|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.335|||||TWO_SIDED|95.0|-0.16|0.77|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.77|-0.16|
91486886|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.273|||||TWO_SIDED|95.0|-0.07|0.74|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.74|-0.07|
91486887|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.854|||||TWO_SIDED|95.0|0.58|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.95|0.58|
91486888|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.537|||||TWO_SIDED|95.0|-0.13|0.85|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.85|-0.13|
91486889|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.536|||||TWO_SIDED|95.0|-0.15|0.89|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.89|-0.15|
91486890|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.527|||||TWO_SIDED|95.0|-0.1|0.87|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.87|-0.10|
91486891|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.574|||||TWO_SIDED|95.0|-0.1|0.88|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.88|-0.10|
91486892|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.454|||||TWO_SIDED|95.0|-0.05|0.85|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.85|-0.05|
91678144|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91486893|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.834|||||TWO_SIDED|95.0|0.54|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.95|0.54|
91486894|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.317|||||TWO_SIDED|95.0|-0.27|0.72|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.72|-0.27|
91486895|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.789|||||TWO_SIDED|95.0|-0.18|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.96|-0.18|
91678145|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91678146|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678147|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678148|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91486896|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.737|||||TWO_SIDED|95.0|0.09|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.92|0.09|
91486897|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.3|||||TWO_SIDED|95.0|-0.19|0.69|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.69|-0.19|
91486898|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.936|||||TWO_SIDED|95.0|0.81|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.98|0.81|
91486899|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.82|||||TWO_SIDED|95.0|0.42|0.95|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.95|0.42|
91486900|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.521|||||TWO_SIDED|95.0|0.19|0.79|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.79|0.19|
91486901|NCT04823650|182846743|OTHER||Intraclass correlation coefficient|0.871|||||TWO_SIDED|95.0|-0.09|0.98|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.98|-0.09|
91486902|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.548|||||TWO_SIDED|95.0|0.02|0.84|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.84|0.02|
91486903|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.731|||||TWO_SIDED|95.0|0.35|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.91|0.35|
91486904|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.623|||||TWO_SIDED|95.0|0.14|0.87|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.87|0.14|
91486905|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.491|||||TWO_SIDED|95.0|-0.11|0.82|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.82|-0.11|
91678149|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678150|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678151|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678152|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678153|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678154|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
91678155|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678156|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678157|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91486906|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.136|||||TWO_SIDED|95.0|-0.01|0.52|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.52|-0.01|
91486907|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.157|||||TWO_SIDED|95.0|-0.04|0.59|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.59|-0.04|
91486908|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.649|||||TWO_SIDED|95.0|0.17|0.88|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.88|0.17|
91486909|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.259|||||TWO_SIDED|95.0|-0.04|0.71|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.71|-0.04|
91526763|NCT00510458|182928938|OTHER|To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91678158|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678159|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91678160|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678161|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678162|NCT02504671|183250060|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678163|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678164|NCT02504671|183250060|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678165|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678166|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91678167|NCT02504671|183250060|OTHER||Difference|29.7|||||TWO_SIDED|95.0|12.7|46.8|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.8|12.7|
91678168|NCT02504671|183250060|OTHER||Difference|37.8|||||TWO_SIDED|95.0|20.3|55.4|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.4|20.3|
91678169|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678170|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678171|NCT02504671|183250060|OTHER||Difference|37.8|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
91678172|NCT02504671|183250060|OTHER||Difference|51.4|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
91678173|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
91678174|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
91678175|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4, ACR70. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678176|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
91678177|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|3.5|45.2|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.2|3.5|
91678178|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
91678179|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
91678180|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678181|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678182|NCT02504671|183250060|OTHER||Difference|32.4|||||TWO_SIDED|95.0|12.4|52.4|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||52.4|12.4|
91678183|NCT02504671|183250060|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
91678184|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
91486910|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.242|||||TWO_SIDED|95.0|-0.04|0.7|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.70|-0.04|
91486911|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.24|||||TWO_SIDED|95.0|-0.18|0.66|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.66|-0.18|
91486912|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.481|||||TWO_SIDED|95.0|-0.21|0.83|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.83|-0.21|
91486913|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.31|||||TWO_SIDED|95.0|-0.19|0.72|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.72|-0.19|
91486914|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.096|||||TWO_SIDED|95.0|-0.07|0.46|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.46|-0.07|
91678185|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678186|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678187|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
91678188|NCT02504671|183250060|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
91678189|NCT02504671|183250060|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
91678190|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
91678191|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
91678192|NCT02504671|183250060|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
91678193|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
91678194|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
91678195|NCT02504671|183250060|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
91678196|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
91678197|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
91678198|NCT02504671|183250060|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 16, ACR70. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
91678199|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
91678200|NCT02504671|183250060|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.5|63.0|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||63.0|23.5|
91678201|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
91678202|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
91678203|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|3.3|34.5|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|
91678204|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91678205|NCT02504671|183250060|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
91678206|NCT02504671|183250060|OTHER||Difference|45.9|||||TWO_SIDED|95.0|26.7|65.2|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.2|26.7|
91486915|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.1|||||TWO_SIDED|95.0|-0.01|0.44|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.44|-0.01|
91526764|NCT00510458|182928938|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.||||||0.0394|||||||t-test, 2 sided|||||||0.0394
91526765|NCT00510458|182928938|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.||||||0.4974|||||||t-test, 2 sided|||||||0.4974
91486916|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.058|||||TWO_SIDED|95.0|-0.02|0.35|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.35|-0.02|
91526766|NCT00510458|182928938|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.||||||0.677|||||||t-test, 2 sided|||||||0.6770
91526767|NCT00510458|182928939|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91526768|NCT00510458|182928939|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.||||||0.0006|||||||t-test, 2 sided|||||||0.0006
91678207|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-3.6|30.6|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.6|-3.6|
91678208|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
91678209|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91678210|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
91678211|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678212|NCT02504671|183250060|OTHER||Difference|64.9|||||TWO_SIDED|95.0|48.9|80.8|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||80.8|48.9|
91678213|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678214|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
91678215|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678216|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678217|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678218|NCT02504671|183250060|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
91678219|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678220|NCT02504671|183250060|OTHER||Difference|27.0|||||TWO_SIDED|95.0|11.4|42.7|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|11.4|
91678221|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678222|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678223|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678224|NCT02504671|183250060|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
91678225|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678226|NCT02504671|183250060|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
91678227|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
91678228|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91717499|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.747|TWO_SIDED|95.0|-4.9|3.5||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||3.5|-4.9|0.747
91486917|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.206|||||TWO_SIDED|95.0|-0.08|0.59|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.59|-0.08|
91678229|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678230|NCT02504671|183250060|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
91678231|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678232|NCT02504671|183250060|OTHER||Difference|29.7|||||TWO_SIDED|95.0|13.8|45.7|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.7|13.8|
91678233|NCT02504671|183250060|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678234|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678235|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678236|NCT02504671|183250060|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
91678237|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678238|NCT02504671|183250060|OTHER||Difference|35.1|||||TWO_SIDED|95.0|18.7|51.6|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.6|18.7|
91678239|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678240|NCT02504671|183250060|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
91678241|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678242|NCT02504671|183250060|OTHER||Difference|51.4|||||TWO_SIDED|95.0|37.3|70.9|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|37.3|
91678243|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678244|NCT02504671|183250060|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
91678245|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678246|NCT02504671|183250060|OTHER||Difference|21.6|||||TWO_SIDED|95.0|8.4|34.9|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.9|8.4|
91678247|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678248|NCT02504671|183250060|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
91678249|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678250|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
91678251|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91486918|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.247|||||TWO_SIDED|95.0|-0.05|0.7|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.70|-0.05|
91526769|NCT03535337|182929034|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED|95.0|0.28|4.59|||Mixed Models Analysis|||||4.59|0.28|0.03
91486919|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.127|||||TWO_SIDED|95.0|-0.03|0.53|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.53|-0.03|
91678252|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91486920|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|-0.031|||||TWO_SIDED|95.0|-0.25|0.34|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.34|-0.25|
91486921|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.004|||||TWO_SIDED|95.0|-0.13|0.27|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.27|-0.13|
91678253|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678254|NCT02504671|183250060|OTHER||Difference|40.5|||||TWO_SIDED|95.0|23.7|57.3|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.3|23.7|
91678255|NCT02504671|183250060|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
91678256|NCT02504671|183250060|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
91678257|NCT02504671|183250060|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
91678258|NCT02504671|183250060|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
91678259|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678260|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678261|NCT02504671|183250061|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678262|NCT02504671|183250061|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678263|NCT02504671|183250061|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678264|NCT02504671|183250061|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678265|NCT02504671|183250061|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678266|NCT02504671|183250061|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678267|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678268|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678269|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678270|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678271|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678272|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678273|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678274|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678275|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91486922|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|-0.085|||||TWO_SIDED|95.0|-0.21|0.21|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.21|-0.21|
91486923|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|-0.077|||||TWO_SIDED|95.0|-0.5|0.44|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.44|-0.50|
91526770|NCT03535337|182929035|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.76||0.82|TWO_SIDED|95.0|-1.32|1.66|||Mixed Models Analysis|||||1.66|-1.32|0.82
91526771|NCT05879198|182929037|SUPERIORITY|||||||0.473|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.473
91678276|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678277|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678278|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678279|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678280|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678281|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678282|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678283|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678284|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678285|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678286|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678287|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678288|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678289|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678290|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678291|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678292|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678293|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678294|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678295|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678296|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678297|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678298|NCT02504671|183250061|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678299|NCT02504671|183250061|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678300|NCT02504671|183250061|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678301|NCT02504671|183250061|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678302|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678303|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678304|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-2.5|
91678305|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|68.2|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|-1.9|
91678306|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678307|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678308|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678309|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678310|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678311|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678312|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678313|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678314|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678315|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91486924|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.063|||||TWO_SIDED|95.0|-0.31|0.5|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.50|-0.31|
91678316|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678317|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678318|NCT02504671|183250061|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678319|NCT02504671|183250061|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91486925|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|-0.248|||||TWO_SIDED|95.0|-0.62|0.29|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.29|-0.62|
91678320|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678321|NCT02504671|183250061|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678322|NCT02504671|183250061|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678323|NCT02504671|183250061|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91486926|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.331|||||TWO_SIDED|95.0|-0.02|0.69|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.69|-0.02|
91717500|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.338|TWO_SIDED|95.0|-5.3|1.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.8|-5.3|0.338
91717501|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.068|TWO_SIDED|95.0|-3.8|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-3.8|0.068
91717502|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.002|TWO_SIDED|95.0|-4.8|-1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.1|-4.8|0.002
91717503|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.3|-1.0||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.0|-4.3|0.002
91717504|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.012|TWO_SIDED|95.0|-3.4|-0.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.4|-3.4|0.012
91486927|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.217|||||TWO_SIDED|95.0|-0.08|0.59|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.59|-0.08|
91486928|NCT04823650|182846744|OTHER||Intraclass correlation coefficient|0.169|||||TWO_SIDED|95.0|-0.07|0.52|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.52|-0.07|
91486929|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.79|||||TWO_SIDED|95.0|0.45|0.93|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.93|0.45|
91486930|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.876|||||TWO_SIDED|95.0|0.66|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.96|0.66|
91678324|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678325|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678326|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678327|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678328|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678329|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678330|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678331|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678332|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678333|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678334|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678335|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678336|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678337|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678338|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91486931|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.783|||||TWO_SIDED|95.0|0.17|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.94|0.17|
91486932|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.849|||||TWO_SIDED|95.0|-0.13|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.97|-0.13|
91526772|NCT05879198|182929038|SUPERIORITY|||||||0.469|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.469
91678339|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678340|NCT02504671|183250062|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678341|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678342|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678343|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678344|NCT02504671|183250062|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
91678345|NCT02504671|183250062|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678346|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678347|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678348|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678349|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678350|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678351|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678352|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678353|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678354|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678355|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678356|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678357|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678358|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91717505|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.078|TWO_SIDED|95.0|-2.4|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-2.4|0.078
91717506|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.367|TWO_SIDED|95.0|-2.1|5.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||5.7|-2.1|0.367
91717507|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.148|TWO_SIDED|95.0|-7.4|1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.1|-7.4|0.148
91717508|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.314|TWO_SIDED|95.0|-5.9|1.9||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.9|-5.9|0.314
91717509|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2||||0.494|TWO_SIDED|95.0|-2.3|4.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.7|-2.3|0.494
91717510|NCT02557399|183327767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.684|TWO_SIDED|95.0|-3.5|2.3||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||2.3|-3.5|0.684
91717511|NCT02557399|183327768|SUPERIORITY_OR_OTHER||Difference in percentage|2.3||||0.047|TWO_SIDED|95.0|0.1|4.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.6|0.1|0.047
91486933|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.658|||||TWO_SIDED|95.0|-0.06|0.93|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.93|-0.06|
91717512|NCT02557399|183327768|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.185|TWO_SIDED|95.0|-1.3|7.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.3|-1.3|0.185
91717513|NCT02557399|183327768|SUPERIORITY_OR_OTHER||Difference in percentage|3.7||||0.251|TWO_SIDED|95.0|-2.5|9.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.9|-2.5|0.251
91717514|NCT02557399|183327768|SUPERIORITY_OR_OTHER||Difference in percentage|10.2||||0.006|TWO_SIDED|95.0|2.4|18.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||18.0|2.4|0.006
91486934|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.398|||||TWO_SIDED|95.0|-0.05|0.82|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.82|-0.05|
91717515|NCT02557399|183327768|SUPERIORITY_OR_OTHER||Difference in percentage|10.7||||0.022|TWO_SIDED|95.0|0.9|20.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.4|0.9|0.022
91486935|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.776|||||TWO_SIDED|95.0|-0.02|0.95|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.95|-0.02|
91678359|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678360|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678361|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678362|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678363|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678364|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678365|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678366|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678367|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678368|NCT02504671|183250062|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678369|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678370|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678371|NCT02504671|183250062|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678372|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678373|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678374|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678375|NCT02504671|183250062|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678376|NCT02504671|183250062|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678377|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 4, Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678378|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678379|NCT02504671|183250063|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678380|NCT02504671|183250063|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678381|NCT02504671|183250063|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678382|NCT02504671|183250063|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678383|NCT02504671|183250063|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
91678384|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
91678385|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678386|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678387|NCT02504671|183250063|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
91678388|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678389|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678390|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678391|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678392|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678393|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678394|NCT02504671|183250063|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678395|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678396|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678397|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678398|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678399|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91486936|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.681|||||TWO_SIDED|95.0|-0.06|0.93|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.93|-0.06|
91717516|NCT02557399|183327769|SUPERIORITY_OR_OTHER||Difference in percentage|1.8||||0.129|TWO_SIDED|95.0|-0.7|4.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.3|-0.7|0.129
91678400|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678401|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678402|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678403|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678404|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678405|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678406|NCT02504671|183250063|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678407|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678408|NCT02504671|183250063|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678409|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678410|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678411|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678412|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678413|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.6|||7.9|-2.5|
91678414|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678415|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678416|NCT02504671|183250063|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678417|NCT02504671|183250063|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678418|NCT02504671|183250063|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
91678419|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
91678420|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678421|NCT02504671|183250063|OTHER||5.4|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678422|NCT02504671|183250063|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
91678423|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678424|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678425|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678426|NCT02504671|183250063|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678427|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678428|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678429|NCT02504671|183250063|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678430|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678431|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678432|NCT02504671|183250063|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
91678433|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678434|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678435|NCT02504671|183250063|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
91678436|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678437|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678438|NCT02504671|183250063|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
91678439|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91717517|NCT02557399|183327769|SUPERIORITY_OR_OTHER||Difference in percentage|1.3||||0.612|TWO_SIDED|95.0|-3.4|5.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.9|-3.4|0.612
91717518|NCT02557399|183327769|SUPERIORITY_OR_OTHER||Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.1|13.2||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.2|1.1|0.016
91717519|NCT02557399|183327769|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.034|TWO_SIDED|95.0|0.3|15.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.5|0.3|0.034
91717520|NCT02557399|183327769|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.018|TWO_SIDED|95.0|1.4|21.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||21.3|1.4|0.018
91717521|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.379|TWO_SIDED|95.0|-4.5|12.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||12.3|-4.5|0.379
91717522|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|4.7||||0.409|TWO_SIDED|95.0|-5.7|15.1||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.1|-5.7|0.409
91717523|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.18|TWO_SIDED|95.0|-3.1|17.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||17.0|-3.1|0.180
91717524|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5||||0.81|TWO_SIDED|95.0|-8.8|7.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.7|-8.8|0.810
91678440|NCT02504671|183250063|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
91678441|NCT02504671|183250063|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
91678442|NCT02504671|183250064|OTHER||Mean Difference (Net)|-4.09||||0.05|TWO_SIDED|95.0|-8.18|0.0||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, SDAI|||0.00|-8.18|0.050
91717525|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|1.9||||0.648|TWO_SIDED|95.0|-5.2|9.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.0|-5.2|0.648
91486937|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.41|||||TWO_SIDED|95.0|-0.05|0.83|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.83|-0.05|
91678443|NCT02504671|183250064|OTHER||Mean Difference (Net)|-3.66||||0.086|TWO_SIDED|95.0|-7.84|0.52||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||0.52|-7.84|0.086
91678444|NCT02504671|183250064|OTHER||Mean Difference (Net)|-4.33||||0.038|TWO_SIDED|95.0|-8.43|-0.23||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.23|-8.43|0.038
91678445|NCT02504671|183250064|OTHER||Mean Difference (Net)|-4.06||||0.119|TWO_SIDED|95.0|-9.18|1.05||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||1.05|-9.18|0.119
91678446|NCT02504671|183250064|OTHER||Mean Difference (Net)|-4.72||||0.071|TWO_SIDED|95.0|-9.85|0.4||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||0.40|-9.85|0.071
91678447|NCT02504671|183250064|OTHER||Mean Difference (Net)|-5.48||||0.034|TWO_SIDED|95.0|-10.53|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-0.42|-10.53|0.034
91678448|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.78||||0.023|TWO_SIDED|95.0|-12.61|-0.94||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-0.94|-12.61|0.023
91486938|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.044|||||TWO_SIDED|95.0|-0.48|0.56|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.56|-0.48|
91486939|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.938|||||TWO_SIDED|95.0|0.82|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.98|0.82|
91486940|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.861|||||TWO_SIDED|95.0|0.58|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.96|0.58|
91678449|NCT02504671|183250064|OTHER||Mean Difference (Net)|-7.28||||0.014|TWO_SIDED|95.0|-13.09|-1.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-1.47|-13.09|0.014
91486941|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.392|||||TWO_SIDED|95.0|-0.14|0.83|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.83|-0.14|
91678450|NCT02504671|183250064|OTHER||Mean Difference (Net)|-9.23||||0.002|TWO_SIDED|95.0|-14.99|-3.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-3.47|-14.99|0.002
91678451|NCT02504671|183250064|OTHER||Mean Difference (Net)|-5.65||||0.063|TWO_SIDED|95.0|-11.62|0.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||0.32|-11.62|0.063
91678452|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.29||||0.04|TWO_SIDED|95.0|-12.28|-0.3||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.30|-12.28|0.040
91678453|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.79||||0.024|TWO_SIDED|95.0|-12.69|-0.9||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.90|-12.69|0.024
91678454|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.58||||0.05|TWO_SIDED|95.0|-13.15|-0.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-0.01|-13.15|0.050
91486942|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.568|||||TWO_SIDED|95.0|-0.05|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.90|-0.05|
91486943|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.284|||||TWO_SIDED|95.0|-0.03|0.74|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.74|-0.03|
91526773|NCT05879198|182929039|SUPERIORITY|||||||0.155|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.155
91678455|NCT02504671|183250064|OTHER||Mean Difference (Net)|-9.15||||0.006|TWO_SIDED|95.0|-15.71|-2.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.60|-15.71|0.006
91678456|NCT02504671|183250064|OTHER||Mean Difference (Net)|-8.86||||0.007|TWO_SIDED|95.0|-15.32|-2.41||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.41|-15.32|0.007
91678457|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.91||||0.074|TWO_SIDED|95.0|-14.49|0.68||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||0.68|-14.49|0.074
91678458|NCT02504671|183250064|OTHER||Mean Difference (Net)|-10.37||||0.008|TWO_SIDED|95.0|-17.99|-2.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.74|-17.99|0.008
91678459|NCT02504671|183250064|OTHER||Mean Difference (Net)|-14.15|||<|0.001|TWO_SIDED|95.0|-21.64|-6.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-6.67|-21.64|<0.001
91678460|NCT02504671|183250064|OTHER||Mean Difference (Net)|-1.88||||0.656|TWO_SIDED|95.0|-10.19|6.43||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||6.43|-10.19|0.656
91678461|NCT02504671|183250064|OTHER||Mean Difference (Net)|-7.0||||0.093|TWO_SIDED|95.0|-15.19|1.19||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||1.19|-15.19|0.093
91678462|NCT02504671|183250064|OTHER||Mean Difference (Net)|-7.26||||0.076|TWO_SIDED|95.0|-15.3|0.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||0.78|-15.30|0.076
91678463|NCT02504671|183250064|OTHER||Mean Difference (Net)|0.8||||0.86|TWO_SIDED|95.0|-8.14|9.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||9.74|-8.14|0.860
91678464|NCT02504671|183250064|OTHER||Mean Difference (Net)|-5.71||||0.196|TWO_SIDED|95.0|-14.4|2.99||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.99|-14.40|0.196
91678465|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.0||||0.164|TWO_SIDED|95.0|-14.48|2.48||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.48|-14.48|0.164
91717526|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|9.1||||0.048|TWO_SIDED|95.0|-1.3|19.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||19.6|-1.3|0.048
91486944|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.199|||||TWO_SIDED|95.0|-0.07|0.56|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.56|-0.07|
91678466|NCT02504671|183250064|OTHER||Mean Difference (Net)|-10.65||||0.066|TWO_SIDED|95.0|-21.99|0.69||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||0.69|-21.99|0.066
91678467|NCT02504671|183250064|OTHER||Mean Difference (Net)|-16.37||||0.003|TWO_SIDED|95.0|-27.25|-5.49||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.49|-27.25|0.003
91678468|NCT02504671|183250064|OTHER||Mean Difference (Net)|-15.67||||0.004|TWO_SIDED|95.0|-26.3|-5.03||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.03|-26.30|0.004
91678469|NCT02504671|183250064|OTHER||Mean Difference (Net)|-4.78||||0.024|TWO_SIDED|95.0|-8.91|-0.65||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.65|-8.91|0.024
91678470|NCT02504671|183250064|OTHER||Mean Difference (Net)|-7.77|||<|0.001|TWO_SIDED|95.0|-11.84|-3.7||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-3.70|-11.84|<0.001
91678471|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.67||||0.01|TWO_SIDED|95.0|-11.74|-1.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.60|-11.74|0.010
91678472|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.85||||0.008|TWO_SIDED|95.0|-11.91|-1.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.78|-11.91|0.008
91678473|NCT02504671|183250064|OTHER||Mean Difference (Net)|-8.44||||0.004|TWO_SIDED|95.0|-14.2|-2.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-2.67|-14.20|0.004
91678474|NCT02504671|183250064|OTHER||Mean Difference (Net)|-12.51|||<|0.001|TWO_SIDED|95.0|-18.26|-6.75||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-6.75|-18.26|<0.001
91678475|NCT02504671|183250064|OTHER||Mean Difference (Net)|-7.0||||0.022|TWO_SIDED|95.0|-12.99|-1.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-1.01|-12.99|0.022
91678476|NCT02504671|183250064|OTHER||Mean Difference (Net)|-10.16|||<|0.001|TWO_SIDED|95.0|-16.07|-4.24||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-4.24|-16.07|<0.001
91678477|NCT02504671|183250064|OTHER||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-17.7|-4.66||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-4.66|-17.70|<0.001
91678478|NCT02504671|183250064|OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.57|-7.44||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-7.44|-20.57|<0.001
91678479|NCT02504671|183250064|OTHER||Mean Difference (Net)|-9.68||||0.013|TWO_SIDED|95.0|-17.26|-2.11||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.11|-17.26|0.013
91717527|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|11.2||||0.016|TWO_SIDED|95.0|1.8|20.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.6|1.8|0.016
91486945|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.657|||||TWO_SIDED|95.0|-0.04|0.93|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.93|-0.04|
91678480|NCT02504671|183250064|OTHER||Mean Difference (Net)|-16.86|||<|0.001|TWO_SIDED|95.0|-24.39|-9.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-9.32|-24.39|<0.001
91678481|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.03||||0.149|TWO_SIDED|95.0|-14.24|2.18||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||2.18|-14.24|0.149
91678482|NCT02504671|183250064|OTHER||Mean Difference (Net)|-9.43||||0.019|TWO_SIDED|95.0|-17.32|-1.55||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||-1.55|-17.32|0.019
91678483|NCT02504671|183250064|OTHER||Mean Difference (Net)|-6.59||||0.138|TWO_SIDED|95.0|-15.32|2.14||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.14|-15.32|0.138
91678484|NCT02504671|183250064|OTHER||Mean Difference (Net)|-8.7||||0.04|TWO_SIDED|95.0|-16.99|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||-0.42|-16.99|0.040
91678485|NCT02504671|183250064|OTHER||Mean Difference (Net)|-15.88||||0.005|TWO_SIDED|95.0|-26.77|-4.98||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-4.98|-26.77|0.005
91717528|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|8.6||||0.044|TWO_SIDED|95.0|0.4|16.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||16.9|0.4|0.044
91678486|NCT02504671|183250064|OTHER||Mean Difference (Net)|-20.87|||<|0.001|TWO_SIDED|95.0|-31.2|-10.53||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-10.53|-31.20|<0.001
91678487|NCT02504671|183250065|OTHER||Mean Difference (Net)|-3.84||||0.063|TWO_SIDED|95.0|-7.89|0.2||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.20|-7.89|0.063
91678488|NCT02504671|183250065|OTHER||Mean Difference (Net)|-3.84||||0.067|TWO_SIDED|95.0|-7.95|0.28||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.28|-7.95|0.067
91678489|NCT02504671|183250065|OTHER||Mean Difference (Net)|-4.43||||0.032|TWO_SIDED|95.0|-8.46|-0.39||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-0.39|-8.46|0.032
91678490|NCT02504671|183250065|OTHER||Mean Difference (Net)|-4.17||||0.102|TWO_SIDED|95.0|-9.17|0.84||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||0.84|-9.17|0.102
91678491|NCT02504671|183250065|OTHER||Mean Difference (Net)|-3.47||||0.17|TWO_SIDED|95.0|-8.43|1.49||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||1.49|-8.43|0.170
91678492|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.2||||0.039|TWO_SIDED|95.0|-10.13|-0.27||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-0.27|-10.13|0.039
91678493|NCT02504671|183250065|OTHER||Mean Difference (Net)|-7.2||||0.012|TWO_SIDED|95.0|-12.82|-1.57||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.57|-12.82|0.012
91678494|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.73||||0.018|TWO_SIDED|95.0|-12.3|-1.16||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.16|-12.30|0.018
91678495|NCT02504671|183250065|OTHER||Mean Difference (Net)|-9.19||||0.001|TWO_SIDED|95.0|-14.73|-3.66||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-3.66|-14.73|0.001
91678496|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.48||||0.065|TWO_SIDED|95.0|-11.31|0.35||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.35|-11.31|0.065
91678497|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.85||||0.05|TWO_SIDED|95.0|-11.69|0.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.00|-11.69|0.050
91678498|NCT02504671|183250065|OTHER||Mean Difference (Final Values)|-6.63||||0.024|TWO_SIDED|95.0|-12.38|-0.87||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.87|-12.38|0.024
91717529|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|3.6||||0.345|TWO_SIDED|95.0|-3.8|11.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||11.0|-3.8|0.345
91717530|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|2.6||||0.424|TWO_SIDED|95.0|-3.5|8.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.7|-3.5|0.424
91678499|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.41||||0.051|TWO_SIDED|95.0|-12.84|0.02||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||0.02|-12.84|0.051
91678500|NCT02504671|183250065|OTHER||Mean Difference (Net)|-8.6||||0.008|TWO_SIDED|95.0|-14.97|-2.22||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.22|-14.97|0.008
91678501|NCT02504671|183250065|OTHER||Mean Difference (Net)|-8.74||||0.007|TWO_SIDED|95.0|-15.06|-2.43||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.43|-15.06|0.007
91678502|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.8||||0.071|TWO_SIDED|95.0|-14.19|0.58||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||0.58|-14.19|0.071
91678503|NCT02504671|183250065|OTHER||Mean Difference (Net)|-9.8||||0.009|TWO_SIDED|95.0|-17.17|-2.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.44|-17.17|0.009
91678504|NCT02504671|183250065|OTHER||Mean Difference (Net)|-13.88|||<|0.001|TWO_SIDED|95.0|-21.17|-6.59||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-6.59|-21.17|<0.001
91678505|NCT02504671|183250065|OTHER||Mean Difference (Net)|-1.68||||0.676|TWO_SIDED|95.0|-9.63|6.26||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||6.26|-9.63|0.676
91678506|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.33||||0.11|TWO_SIDED|95.0|-14.11|1.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.44|-14.11|0.110
91678507|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.44||||0.099|TWO_SIDED|95.0|-14.12|1.23||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.23|-14.12|0.099
91678508|NCT02504671|183250065|OTHER||Mean Difference (Net)|1.04||||0.812|TWO_SIDED|95.0|-7.61|9.69||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||9.69|-7.61|0.812
91678509|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.39||||0.204|TWO_SIDED|95.0|-13.75|2.96||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.96|-13.75|0.204
91678510|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.9||||0.157|TWO_SIDED|95.0|-14.09|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.30|-14.09|0.157
91678511|NCT02504671|183250065|OTHER||Mean Difference (Net)|-9.37||||0.088|TWO_SIDED|95.0|-20.15|1.42||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||1.42|-20.15|0.088
91678512|NCT02504671|183250065|OTHER||Mean Difference (Net)|-15.12||||0.004|TWO_SIDED|95.0|-25.4|-4.83||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.83|-25.40|0.004
91678513|NCT02504671|183250065|OTHER||Mean Difference (Net)|-14.91||||0.004|TWO_SIDED|95.0|-25.01|-4.8||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.80|-25.01|0.004
91678514|NCT02504671|183250065|OTHER||Mean Difference (Net)|-3.89||||0.06|TWO_SIDED|95.0|-7.96|0.17||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.17|-7.96|0.060
91678515|NCT02504671|183250065|OTHER||Mean Difference (Net)|-7.39|||<|0.001|TWO_SIDED|95.0|-11.42|-3.36||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-3.36|-11.42|<0.001
91678516|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.1||||0.016|TWO_SIDED|95.0|-11.06|-1.14||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.14|-11.06|0.016
91678517|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.85||||0.007|TWO_SIDED|95.0|-11.78|-1.91||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.91|-11.78|0.007
91678518|NCT02504671|183250065|OTHER||Mean Difference (Net)|-7.92||||0.005|TWO_SIDED|95.0|-13.48|-2.37||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-2.37|-13.48|0.005
91678519|NCT02504671|183250065|OTHER||Mean Difference (Net)|-12.19|||<|0.001|TWO_SIDED|95.0|-17.74|-6.64||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-6.64|-17.74|<0.001
91678520|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.62||||0.059|TWO_SIDED|95.0|-11.45|0.21||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.21|-11.45|0.059
91678521|NCT02504671|183250065|OTHER||Mean Difference (Net)|-10.17|||<|0.001|TWO_SIDED|95.0|-15.97|-4.38||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-4.38|-15.97|<0.001
91678522|NCT02504671|183250065|OTHER||Mean Difference (Net)|-10.37||||0.002|TWO_SIDED|95.0|-16.75|-4.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-4.00|-16.75|0.002
91678523|NCT02504671|183250065|OTHER||Mean Difference (Net)|-13.79|||<|0.001|TWO_SIDED|95.0|-20.18|-7.41||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-7.41|-20.18|<0.001
91678524|NCT02504671|183250065|OTHER||Mean Difference (Net)|-9.67||||0.01|TWO_SIDED|95.0|-17.03|-2.31||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.31|-17.03|0.010
91678525|NCT02504671|183250065|OTHER||Mean Difference (Net)|-16.63|||<|0.001|TWO_SIDED|95.0|-23.97|-9.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-9.30|-23.97|<0.001
91678526|NCT02504671|183250065|OTHER||Mean Difference (Net)|-5.53||||0.165|TWO_SIDED|95.0|-13.37|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||2.30|-13.37|0.165
91678527|NCT02504671|183250065|OTHER||Mean Difference (Net)|-8.85||||0.022|TWO_SIDED|95.0|-16.39|-1.32||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||-1.32|-16.39|0.022
91678528|NCT02504671|183250065|OTHER||Mean Difference (Net)|-6.55||||0.127|TWO_SIDED|95.0|-14.99|1.89||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||1.89|-14.99|0.127
91678529|NCT02504671|183250065|OTHER||Mean Difference (Net)|-8.67||||0.034|TWO_SIDED|95.0|-16.67|-0.67||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||-0.67|-16.67|0.034
91678530|NCT02504671|183250065|OTHER||Mean Difference (Net)|-15.43||||0.004|TWO_SIDED|95.0|-25.78|-5.07||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-5.07|-25.78|0.004
91678531|NCT02504671|183250065|OTHER||Mean Difference (Net)|-19.88|||<|0.001|TWO_SIDED|95.0|-29.7|-10.06||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-10.06|-29.70|<0.001
91678532|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.01||||0.938|TWO_SIDED|95.0|-0.14|0.16||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.16|-0.14|0.938
91717531|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0||||0.527|TWO_SIDED|95.0|-9.4|5.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.5|-9.4|0.527
91717532|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|3.3||||0.584|TWO_SIDED|95.0|-6.7|13.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.4|-6.7|0.584
91486946|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.409|||||TWO_SIDED|95.0|-0.04|0.83|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.83|-0.04|
91678533|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.0||||0.981|TWO_SIDED|95.0|-0.15|0.15||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.15|-0.15|0.981
91678534|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.01||||0.857|TWO_SIDED|95.0|-0.16|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.14|-0.16|0.857
91678535|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.05||||0.592|TWO_SIDED|95.0|-0.13|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.22|-0.13|0.592
91678536|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.01||||0.917|TWO_SIDED|95.0|-0.16|0.18||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.18|-0.16|0.917
91678537|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.05||||0.545|TWO_SIDED|95.0|-0.23|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.12|-0.23|0.545
91678538|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.04||||0.707|TWO_SIDED|95.0|-0.16|0.24||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.24|-0.16|0.707
91678539|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.05||||0.603|TWO_SIDED|95.0|-0.15|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.26|-0.15|0.603
91678540|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.27|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.27|0.473
91678541|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.21|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.22|-0.21|0.987
91678542|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.04||||0.713|TWO_SIDED|95.0|-0.25|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.17|-0.25|0.713
91678543|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.31|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.11|-0.31|0.357
91678544|NCT02504671|183250066|OTHER||Mean Difference (Final Values)|0.04||||0.748|TWO_SIDED|95.0|-0.19|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.26|-0.19|0.748
91678545|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.11||||0.327|TWO_SIDED|95.0|-0.34|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.11|-0.34|0.327
91678546|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.1||||0.395|TWO_SIDED|95.0|-0.32|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.13|-0.32|0.395
91678547|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.05||||0.71|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.710
91678548|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.04||||0.74|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.740
91678549|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.11||||0.398|TWO_SIDED|95.0|-0.36|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.14|-0.36|0.398
91678550|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.16||||0.364|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.52|-0.19|0.364
91678551|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.12||||0.503|TWO_SIDED|95.0|-0.23|0.46||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.46|-0.23|0.503
91678552|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.08||||0.647|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.26|-0.42|0.647
91486947|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.733|||||TWO_SIDED|95.0|-0.18|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.94|-0.18|
91486948|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.594|||||TWO_SIDED|95.0|-0.21|0.89|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.89|-0.21|
91486949|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.392|||||TWO_SIDED|95.0|-0.21|0.79|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.79|-0.21|
91486950|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.903|||||TWO_SIDED|95.0|0.71|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.97|0.71|
91486951|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.862|||||TWO_SIDED|95.0|0.62|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.95|0.62|
91486952|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.694|||||TWO_SIDED|95.0|0.26|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.90|0.26|
91678553|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.02||||0.91|TWO_SIDED|95.0|-0.37|0.33||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.33|-0.37|0.910
91486953|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.786|||||TWO_SIDED|95.0|-0.07|0.95|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.95|-0.07|
91486954|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.694|||||TWO_SIDED|95.0|0.02|0.91|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.91|0.02|
91486955|NCT04823650|182846745|OTHER||Intraclass correlation coefficient|0.505|||||TWO_SIDED|95.0|-0.06|0.83|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.83|-0.06|
91486956|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.902|||||TWO_SIDED|95.0|0.71|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.97|0.71|
91486957|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.969|||||TWO_SIDED|95.0|0.9|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.99|0.90|
91678554|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.08||||0.66|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.26|-0.42|0.660
91486958|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.963|||||TWO_SIDED|95.0|0.88|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.99|0.88|
91486959|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.892|||||TWO_SIDED|95.0|0.58|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.97|0.58|
91486960|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.731|||||TWO_SIDED|95.0|-0.02|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.95|-0.02|
91486961|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.637|||||TWO_SIDED|95.0|-0.04|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.92|-0.04|
91526774|NCT05879198|182929040|SUPERIORITY|||||||0.346|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.346
91526775|NCT05879198|182929042|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-positive scale scores.||||.075
91526776|NCT05879198|182929042|SUPERIORITY|||||||0.32|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-negative scale scores.||||.320
91678555|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.16||||0.34|TWO_SIDED|95.0|-0.5|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.17|-0.50|0.340
91678556|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.02||||0.902|TWO_SIDED|95.0|-0.34|0.39||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.39|-0.34|0.902
91678557|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.28|-0.42|0.687
91678558|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.09||||0.599|TWO_SIDED|95.0|-0.44|0.25||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.25|-0.44|0.599
91678559|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.04||||0.588|TWO_SIDED|95.0|-0.19|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.11|-0.19|0.588
91678560|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.09||||0.259|TWO_SIDED|95.0|-0.23|0.06||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.06|-0.23|0.259
91678561|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.08||||0.358|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.358
91678562|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.09||||0.325|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.325
91678563|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.28|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.28|0.473
91678564|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.18||||0.085|TWO_SIDED|95.0|-0.38|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.02|-0.38|0.085
91678565|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.01||||0.897|TWO_SIDED|95.0|-0.2|0.23||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.23|-0.20|0.897
91678566|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.2||||0.065|TWO_SIDED|95.0|-0.42|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.01|-0.42|0.065
91678567|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.14||||0.238|TWO_SIDED|95.0|-0.36|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.09|-0.36|0.238
91678568|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.21||||0.071|TWO_SIDED|95.0|-0.44|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.02|-0.44|0.071
91678569|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.12||||0.34|TWO_SIDED|95.0|-0.38|0.13||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.13|-0.38|0.340
91678570|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.24||||0.059|TWO_SIDED|95.0|-0.49|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.01|-0.49|0.059
91678571|NCT02504671|183250066|OTHER||Mean Difference (Net)|0.09||||0.607|TWO_SIDED|95.0|-0.26|0.44||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.44|-0.26|0.607
91678572|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.01||||0.959|TWO_SIDED|95.0|-0.34|0.32||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.32|-0.34|0.959
91526777|NCT05879198|182929042|SUPERIORITY|||||||0.049|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-positive scale scores.||||.049
91678573|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.15||||0.401|TWO_SIDED|95.0|-0.49|0.2||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.20|-0.49|0.401
91678574|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.21||||0.207|TWO_SIDED|95.0|-0.54|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.12|-0.54|0.207
91678575|NCT02504671|183250066|OTHER||Mean Difference (Net)|-0.08||||0.637|TWO_SIDED|95.0|-0.44|0.27||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.27|-0.44|0.637
91678576|NCT02504671|183250066|OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.53|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.14|-0.53|0.251
91678577|NCT02504671|183250067|OTHER||Mean Difference (Net)|-2.45||||0.511|TWO_SIDED|95.0|-9.81|4.9||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.90|-9.81|0.511
91678578|NCT02504671|183250067|OTHER||Mean Difference (Net)|-2.76||||0.461|TWO_SIDED|95.0|-10.13|4.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.60|-10.13|0.461
91678579|NCT02504671|183250067|OTHER||Mean Difference (Net)|-7.71||||0.039|TWO_SIDED|95.0|-15.03|-0.39||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||-0.39|-15.03|0.039
91678580|NCT02504671|183250067|OTHER||Mean Difference (Net)|-2.92||||0.469|TWO_SIDED|95.0|-10.86|5.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||5.01|-10.86|0.469
91678581|NCT02504671|183250067|OTHER||Mean Difference (Net)|-5.99||||0.133|TWO_SIDED|95.0|-13.82|1.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||1.85|-13.82|0.133
91678582|NCT02504671|183250067|OTHER||Mean Difference (Net)|-7.58||||0.057|TWO_SIDED|95.0|-15.4|0.23||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.23|-15.40|0.057
91678583|NCT02504671|183250067|OTHER||Mean Difference (Net)|-3.03||||0.49|TWO_SIDED|95.0|-11.67|5.61||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||5.61|-11.67|0.490
91678584|NCT02504671|183250067|OTHER||Mean Difference (Net)|-9.38||||0.031|TWO_SIDED|95.0|-17.91|-0.86||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-0.86|-17.91|0.031
91678585|NCT02504671|183250067|OTHER||Mean Difference (Net)|-12.21||||0.005|TWO_SIDED|95.0|-20.67|-3.74||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-3.74|-20.67|0.005
91678586|NCT02504671|183250067|OTHER||Mean Difference (Net)|-4.49||||0.345|TWO_SIDED|95.0|-13.83|4.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||4.85|-13.83|0.345
91678587|NCT02504671|183250067|OTHER||Mean Difference (Net)|-8.02||||0.09|TWO_SIDED|95.0|-17.3|1.26||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.26|-17.30|0.090
91678588|NCT02504671|183250067|OTHER||Mean Difference (Net)|-8.36||||0.074|TWO_SIDED|95.0|-17.55|0.83||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||0.83|-17.55|0.074
91678589|NCT02504671|183250067|OTHER||Mean Difference (Net)|-5.61||||0.268|TWO_SIDED|95.0|-15.57|4.34||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||4.34|-15.57|0.268
91678590|NCT02504671|183250067|OTHER||Mean Difference (Net)|-14.57||||0.004|TWO_SIDED|95.0|-24.43|-4.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.70|-24.43|0.004
91678591|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.94||||0.005|TWO_SIDED|95.0|-23.72|-4.16||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.16|-23.72|0.005
91678592|NCT02504671|183250067|OTHER||Mean Difference (Net)|-7.02||||0.182|TWO_SIDED|95.0|-17.36|3.32||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||3.32|-17.36|0.182
91678593|NCT02504671|183250067|OTHER||Mean Difference (Net)|-14.15||||0.007|TWO_SIDED|95.0|-24.42|-3.87||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-3.87|-24.42|0.007
91678594|NCT02504671|183250067|OTHER||Mean Difference (Net)|-18.18|||<|0.001|TWO_SIDED|95.0|-28.35|-8.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-8.01|-28.35|<0.001
91526778|NCT05879198|182929042|SUPERIORITY|||||||0.089|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-negative scale scores.||||.089
91678595|NCT02504671|183250067|OTHER||Mean Difference (Net)|-4.89||||0.527|TWO_SIDED|95.0|-20.15|10.36||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||10.36|-20.15|0.527
91678596|NCT02504671|183250067|OTHER||Mean Difference (Net)|-15.95||||0.034|TWO_SIDED|95.0|-30.72|-1.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||-1.19|-30.72|0.034
91678597|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.86||||0.062|TWO_SIDED|95.0|-28.42|0.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||0.70|-28.42|0.062
91678598|NCT02504671|183250067|OTHER||Mean Difference (Net)|-0.69||||0.924|TWO_SIDED|95.0|-14.85|13.47||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||13.47|-14.85|0.924
91678599|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.17||||0.058|TWO_SIDED|95.0|-26.82|0.48||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||0.48|-26.82|0.058
91678600|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.49||||0.049|TWO_SIDED|95.0|-26.91|-0.08||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.08|-26.91|0.049
91678601|NCT02504671|183250067|OTHER||Mean Difference (Net)|-6.38||||0.445|TWO_SIDED|95.0|-22.84|10.07||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||10.07|-22.84|0.445
91678602|NCT02504671|183250067|OTHER||Mean Difference (Net)|-10.14||||0.205|TWO_SIDED|95.0|-25.87|5.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||5.58|-25.87|0.205
91678603|NCT02504671|183250067|OTHER||Mean Difference (Net)|-12.07||||0.125|TWO_SIDED|95.0|-27.55|3.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||3.41|-27.55|0.125
91678604|NCT02504671|183250067|OTHER||Mean Difference (Net)|-4.93||||0.187|TWO_SIDED|95.0|-12.26|2.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||2.41|-12.26|0.187
91678605|NCT02504671|183250067|OTHER||Mean Difference (Net)|-5.63||||0.13|TWO_SIDED|95.0|-12.93|1.67||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||1.67|-12.93|0.130
91678606|NCT02504671|183250067|OTHER||Mean Difference (Net)|-7.85||||0.051|TWO_SIDED|95.0|-15.72|0.03||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.03|-15.72|0.051
91486962|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.77|||||TWO_SIDED|95.0|0.36|0.93|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.93|0.36|
91486963|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.715|||||TWO_SIDED|95.0|-0.08|0.94|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.94|-0.08|
91486964|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.767|||||TWO_SIDED|95.0|0.04|0.96|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.96|0.04|
91678607|NCT02504671|183250067|OTHER||Mean Difference (Net)|-10.44||||0.009|TWO_SIDED|95.0|-18.27|-2.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||-2.60|-18.27|0.009
91678608|NCT02504671|183250067|OTHER||Mean Difference (Net)|-7.94||||0.068|TWO_SIDED|95.0|-16.47|0.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||0.58|-16.47|0.068
91678609|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.96||||0.001|TWO_SIDED|95.0|-22.47|-5.44||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-5.44|-22.47|0.001
91678610|NCT02504671|183250067|OTHER||Mean Difference (Net)|-7.36||||0.118|TWO_SIDED|95.0|-16.62|1.89||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.89|-16.62|0.118
91678611|NCT02504671|183250067|OTHER||Mean Difference (Net)|-12.43||||0.009|TWO_SIDED|95.0|-21.68|-3.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||-3.19|-21.68|0.009
91486965|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.24|||||TWO_SIDED|95.0|-0.18|0.66|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.66|-0.18|
91486966|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.66|||||TWO_SIDED|95.0|-0.21|0.83|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.83|-0.21|
91486967|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.31|||||TWO_SIDED|95.0|-0.19|0.72|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.72|-0.19|
91486968|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.096|||||TWO_SIDED|95.0|-0.07|0.46|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.46|-0.07|
91486969|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.1|||||TWO_SIDED|95.0|-0.01|0.44|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.44|-0.01|
91486970|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.058|||||TWO_SIDED|95.0|-0.02|0.35|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.35|-0.02|
91678612|NCT02504671|183250067|OTHER||Mean Difference (Net)|-16.51||||0.001|TWO_SIDED|95.0|-26.38|-6.65||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-6.65|-26.38|0.001
91678613|NCT02504671|183250067|OTHER||Mean Difference (Net)|-20.39|||<|0.001|TWO_SIDED|95.0|-30.27|-10.52||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-10.52|-30.27|<0.001
91678614|NCT02504671|183250067|OTHER||Mean Difference (Net)|-12.0||||0.022|TWO_SIDED|95.0|-22.27|-1.73||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-1.73|-22.27|0.022
91678615|NCT02504671|183250067|OTHER||Mean Difference (Net)|-17.94|||<|0.001|TWO_SIDED|95.0|-28.18|-7.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-7.70|-28.18|<0.001
91678616|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.2||||0.084|TWO_SIDED|95.0|-28.18|1.79||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||1.79|-28.18|0.084
91678617|NCT02504671|183250067|OTHER||Mean Difference (Net)|-11.87||||0.099|TWO_SIDED|95.0|-26.02|2.27||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||2.27|-26.02|0.099
91678618|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.91||||0.048|TWO_SIDED|95.0|-27.68|-0.14||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.14|-27.68|0.048
91678619|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.22||||0.048|TWO_SIDED|95.0|-26.32|-0.13||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.13|-26.32|0.048
91678620|NCT02504671|183250067|OTHER||Mean Difference (Net)|-13.23||||0.102|TWO_SIDED|95.0|-29.11|2.64||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||2.64|-29.11|0.102
91486971|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.206|||||TWO_SIDED|95.0|-0.08|0.59|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.59|-0.08|
91486972|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.247|||||TWO_SIDED|95.0|-0.05|0.7|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.70|-0.05|
91678621|NCT02504671|183250067|OTHER||Mean Difference (Net)|-16.7||||0.03|TWO_SIDED|95.0|-31.79|-1.62||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||-1.62|-31.79|0.030
91486973|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.127|||||TWO_SIDED|95.0|-0.03|0.53|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.53|-0.03|
91678622|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.6||||0.683|TWO_SIDED|95.0|-2.31|3.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||3.52|-2.31|0.683
91678623|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.19||||0.03|TWO_SIDED|95.0|0.31|6.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||6.07|0.31|0.030
91678624|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.61||||0.074|TWO_SIDED|95.0|-0.25|5.47||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.47|-0.25|0.074
91678625|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.46||||0.39|TWO_SIDED|95.0|-1.88|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||4.80|-1.88|0.390
91678626|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.42||||0.154|TWO_SIDED|95.0|-0.91|5.75||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.75|-0.91|0.154
91678627|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.73||||0.302|TWO_SIDED|95.0|-1.56|5.02||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.02|-1.56|0.302
91678628|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.69||||0.521|TWO_SIDED|95.0|-3.5|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.88|-3.50|0.521
91678629|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.28||||0.606|TWO_SIDED|95.0|-3.63|6.2||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.20|-3.63|0.606
91678630|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.46||||0.32|TWO_SIDED|95.0|-2.41|7.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.32|-2.41|0.320
91678631|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.5||||0.811|TWO_SIDED|95.0|-4.65|3.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.64|-4.65|0.811
91678632|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.45||||0.83|TWO_SIDED|95.0|-3.65|4.55||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.55|-3.65|0.830
91678633|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.54||||0.795|TWO_SIDED|95.0|-4.61|3.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.54|-4.61|0.795
91678634|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.32||||0.548|TWO_SIDED|95.0|-3.0|5.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.64|-3.00|0.548
91678635|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.46||||0.505|TWO_SIDED|95.0|-2.85|5.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.77|-2.85|0.505
91678636|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.12||||0.605|TWO_SIDED|95.0|-3.15|5.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.39|-3.15|0.605
91678637|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.43||||0.895|TWO_SIDED|95.0|-6.03|6.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||6.90|-6.03|0.895
91678638|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.29||||0.461|TWO_SIDED|95.0|-3.84|8.42||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||8.42|-3.84|0.461
91678639|NCT02504671|183250068|OTHER||Mean Difference (Net)|-1.05||||0.732|TWO_SIDED|95.0|-7.1|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||4.99|-7.10|0.732
91678640|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.11||||0.941|TWO_SIDED|95.0|-3.11|2.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||2.88|-3.11|0.941
91678641|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.73||||0.013|TWO_SIDED|95.0|0.78|6.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||6.67|0.78|0.013
91678642|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.92||||0.051|TWO_SIDED|95.0|-0.01|5.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||5.84|-0.01|0.051
91486974|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.377|||||TWO_SIDED|95.0|-0.15|0.75|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.75|-0.15|
91486975|NCT04823650|182846746|OTHER||Intra-class correlation coefficient|0.44|||||TWO_SIDED|95.0|-0.21|0.81|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.81|-0.21|
91678643|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.53||||0.403|TWO_SIDED|95.0|-2.07|5.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.12|-2.07|0.403
91678644|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.82||||0.122|TWO_SIDED|95.0|-0.76|6.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||6.40|-0.76|0.122
91678645|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.08||||0.247|TWO_SIDED|95.0|-1.45|5.62||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.62|-1.45|0.247
91678646|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.85||||0.384|TWO_SIDED|95.0|-3.61|9.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.32|-3.61|0.384
91678647|NCT02504671|183250068|OTHER||Mean Difference (Net)|5.05||||0.105|TWO_SIDED|95.0|-1.07|11.16||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||11.16|-1.07|0.105
91678648|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.21||||0.29|TWO_SIDED|95.0|-2.76|9.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.17|-2.76|0.290
91678649|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.51||||0.738|TWO_SIDED|95.0|-3.52|2.5||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||2.50|-3.52|0.738
91678650|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.99||||0.513|TWO_SIDED|95.0|-1.99|3.97||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.97|-1.99|0.513
91678651|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.12||||0.934|TWO_SIDED|95.0|-2.83|3.08||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.08|-2.83|0.934
91678652|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.63||||0.687|TWO_SIDED|95.0|-2.43|3.68||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.68|-2.43|0.687
91678653|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.85||||0.233|TWO_SIDED|95.0|-1.2|4.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||4.91|-1.20|0.233
91678654|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.57||||0.708|TWO_SIDED|95.0|-2.44|3.59||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.59|-2.44|0.708
91678655|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.29||||0.25|TWO_SIDED|95.0|-2.34|8.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.93|-2.34|0.250
91678656|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.76||||0.307|TWO_SIDED|95.0|-2.57|8.09||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.09|-2.57|0.307
91678657|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.53||||0.345|TWO_SIDED|95.0|-2.74|7.79||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||7.79|-2.74|0.345
91678658|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.16||||0.95|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||0.52|-0.19|0.950
91678659|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.88||||0.664|TWO_SIDED|95.0|-3.11|4.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||4.87|-3.11|0.664
91678660|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.01||||0.994|TWO_SIDED|95.0|-3.99|3.96||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||3.96|-3.99|0.994
91678661|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.6||||0.25|TWO_SIDED|95.0|-1.84|7.03||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.03|-1.84|0.250
91678662|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.21||||0.154|TWO_SIDED|95.0|-1.22|7.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.64|-1.22|0.154
91678663|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.5||||0.262|TWO_SIDED|95.0|-1.88|6.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||6.89|-1.88|0.262
91678664|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.32||||0.693|TWO_SIDED|95.0|-5.28|7.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||7.93|-5.28|0.693
91678665|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.28||||0.302|TWO_SIDED|95.0|-2.98|9.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||9.54|-2.98|0.302
91678666|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.61||||0.844|TWO_SIDED|95.0|-5.54|6.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||6.77|-5.54|0.844
91678667|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.66||||0.698|TWO_SIDED|95.0|-2.71|4.04||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.04|-2.71|0.698
91678668|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.38||||0.159|TWO_SIDED|95.0|-0.94|5.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||5.70|-0.94|0.159
91678669|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.53||||0.36|TWO_SIDED|95.0|-1.76|4.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.83|-1.76|0.360
91678670|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.82||||0.151|TWO_SIDED|95.0|-1.04|6.69||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.69|-1.04|0.151
91678671|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.01||||0.124|TWO_SIDED|95.0|-0.83|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.86|-0.83|0.124
91678672|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.0||||0.12|TWO_SIDED|95.0|-0.79|6.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.80|-0.79|0.120
91678673|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.64||||0.814|TWO_SIDED|95.0|-5.98|4.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.70|-5.98|0.814
91678674|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.41||||0.873|TWO_SIDED|95.0|-5.49|4.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.67|-5.49|0.873
91678675|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.23||||0.928|TWO_SIDED|95.0|-4.8|5.26||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||5.26|-4.80|0.928
91678676|NCT02504671|183250068|OTHER||Mean Difference (Net)|-1.29||||0.541|TWO_SIDED|95.0|-5.44|2.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.86|-5.44|0.541
91678677|NCT02504671|183250068|OTHER||Mean Difference (Net)|-1.29||||0.535|TWO_SIDED|95.0|-5.39|2.81||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.81|-5.39|0.535
91678678|NCT02504671|183250068|OTHER||Mean Difference (Net)|-1.03||||0.62|TWO_SIDED|95.0|-5.1|3.05||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||3.05|-5.10|0.620
91678679|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.34||||0.881|TWO_SIDED|95.0|-4.08|4.76||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.76|-4.08|0.881
91678680|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.66||||0.767|TWO_SIDED|95.0|-3.74|5.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,Role Emotional|||5.07|-3.74|0.767
91678681|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.24||||0.913|TWO_SIDED|95.0|-4.12|4.61||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.61|-4.12|0.913
91678682|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.91||||0.79|TWO_SIDED|95.0|-5.81|7.63||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||7.63|-5.81|0.790
91678683|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.5||||0.876|TWO_SIDED|95.0|-5.86|6.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||6.87|-5.86|0.876
91678684|NCT02504671|183250068|OTHER||Mean Difference (Net)|-1.3||||0.684|TWO_SIDED|95.0|-7.59|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||4.99|-7.59|0.684
91678685|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.86||||0.588|TWO_SIDED|95.0|-2.28|4.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||4.01|-2.28|0.588
91678686|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.21|5.0||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.00|-1.21|0.229
91678687|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.41||||0.125|TWO_SIDED|95.0|-0.67|5.49||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.49|-0.67|0.125
91678688|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.6||||0.736|TWO_SIDED|95.0|-2.92|4.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.12|-2.92|0.736
91678689|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.72||||0.338|TWO_SIDED|95.0|-1.8|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||5.23|-1.80|0.338
91678690|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.92||||0.6|TWO_SIDED|95.0|-2.55|4.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.40|-2.55|0.600
91678691|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.26||||0.657|TWO_SIDED|95.0|-4.34|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.86|-4.34|0.657
91486976|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.08|||||TWO_SIDED|95.0|-0.23|0.5|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.50|-0.23|
91486977|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.398|||||TWO_SIDED|95.0|-0.12|0.76|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.76|-0.12|
91486978|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.651|||||TWO_SIDED|95.0|0.04|0.89|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.89|0.04|
91678692|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.12||||0.965|TWO_SIDED|95.0|-5.41|5.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||5.17|-5.41|0.965
91678693|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.12||||0.675|TWO_SIDED|95.0|-4.14|6.37||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.37|-4.14|0.675
91678694|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.32||||0.88|TWO_SIDED|95.0|-4.54|3.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||3.89|-4.54|0.880
91678695|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.17||||0.135|TWO_SIDED|95.0|-1.0|7.33||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||7.33|-1.00|0.135
91678696|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.57||||0.785|TWO_SIDED|95.0|-3.56|4.71||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||4.71|-3.56|0.785
91678697|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.55||||0.797|TWO_SIDED|95.0|-3.69|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.80|-3.69|0.797
91678698|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-4.23|4.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.23|-4.23|>0.999
91678699|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.28||||0.896|TWO_SIDED|95.0|-3.91|4.46||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.46|-3.91|0.896
91678700|NCT02504671|183250068|OTHER||Mean Difference (Net)|-2.89||||0.424|TWO_SIDED|95.0|-10.02|4.24||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||4.24|-10.02|0.424
91678701|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.44||||0.898|TWO_SIDED|95.0|-7.16|6.29||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.29|-7.16|0.898
91678702|NCT02504671|183250068|OTHER||Mean Difference (Net)|-3.79||||0.26|TWO_SIDED|95.0|-10.42|2.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||2.84|-10.42|0.260
91678703|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.02||||0.603|TWO_SIDED|95.0|-2.85|4.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||4.90|-2.85|0.603
91678704|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.56||||0.068|TWO_SIDED|95.0|-0.26|7.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||7.39|-0.26|0.068
91678705|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.63||||0.174|TWO_SIDED|95.0|-1.17|6.43||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||6.43|-1.17|0.174
91678706|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.97||||0.334|TWO_SIDED|95.0|-2.04|5.98||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||5.98|-2.04|0.334
91678707|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.91||||0.153|TWO_SIDED|95.0|-1.09|6.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.91|-1.09|0.153
91678708|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.18||||0.279|TWO_SIDED|95.0|-1.78|6.13||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.13|-1.78|0.279
91678709|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.94||||0.584|TWO_SIDED|95.0|-5.04|8.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,Vitality|||8.91|-5.04|0.584
91678710|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.15||||0.346|TWO_SIDED|95.0|-3.44|9.73||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.73|-3.44|0.346
91678711|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.97||||0.37|TWO_SIDED|95.0|-3.55|9.48||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.48|-3.55|0.370
91678712|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.94||||0.045|TWO_SIDED|95.0|0.06|5.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.83|0.06|0.045
91678713|NCT02504671|183250068|OTHER||Mean Difference (Net)|4.11||||0.006|TWO_SIDED|95.0|1.22|7.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||7.01|1.22|0.006
91678714|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.89||||0.264|TWO_SIDED|95.0|-1.44|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||5.23|-1.44|0.264
91678715|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.55||||0.037|TWO_SIDED|95.0|0.22|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||6.88|0.22|0.037
91486979|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.13|||||TWO_SIDED|95.0|-0.34|0.59|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.59|-0.34|
91678716|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.16||||0.392|TWO_SIDED|95.0|-2.81|7.14||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.14|-2.81|0.392
91678717|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.65||||0.493|TWO_SIDED|95.0|-3.09|6.39||MMRM analysis adjusted for PCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.39|-3.09|0.493
91678718|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.16||||0.577|TWO_SIDED|95.0|-2.94|5.26||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||5.26|-2.94|0.577
91678719|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.1||||0.964|TWO_SIDED|95.0|-4.01|4.2||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.20|-4.01|0.964
91678720|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.97||||0.37|TWO_SIDED|95.0|-2.35|6.28||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||6.28|-2.35|0.370
91678721|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.25||||0.138|TWO_SIDED|95.0|-1.05|7.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||7.54|-1.05|0.138
91678722|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.36||||0.667|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.667
91678723|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.79||||0.203|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.203
91678724|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.45||||0.023|TWO_SIDED|95.0|0.49|6.41||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||6.41|0.49|0.023
91678725|NCT02504671|183250068|OTHER||Mean Difference (Net)|5.08|||<|0.001|TWO_SIDED|95.0|2.14|8.03||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||8.03|2.14|<0.001
91486980|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.639|||||TWO_SIDED|95.0|0.25|0.87|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.87|0.25|
91678726|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.11||||0.249|TWO_SIDED|95.0|-1.49|5.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||5.70|-1.49|0.249
91678727|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.43||||0.059|TWO_SIDED|95.0|-0.13|6.99||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||6.99|-0.13|0.059
91678728|NCT02504671|183250068|OTHER||Mean Difference (Net)|4.72||||0.134|TWO_SIDED|95.0|-1.47|10.9||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.90|-1.47|0.134
91678729|NCT02504671|183250068|OTHER||Mean Difference (Net)|5.2||||0.078|TWO_SIDED|95.0|-0.58|10.97||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.97|-0.58|0.078
91678730|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.65||||0.275|TWO_SIDED|95.0|-1.32|4.62||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.62|-1.32|0.275
91678731|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.94||||0.199|TWO_SIDED|95.0|-1.03|4.91||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.91|-1.03|0.199
91678732|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.69||||0.654|TWO_SIDED|95.0|-2.36|3.74||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||3.74|-2.36|0.654
91678733|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.29||||0.138|TWO_SIDED|95.0|-0.74|5.33||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||5.33|-0.74|0.138
91678734|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.77||||0.516|TWO_SIDED|95.0|-3.62|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||7.17|-3.62|0.516
91678735|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.35||||0.198|TWO_SIDED|95.0|-1.77|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||8.46|-1.77|0.198
91678736|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.15||||0.941|TWO_SIDED|95.0|-4.15|3.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||3.84|-4.15|0.941
91678737|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.05||||0.979|TWO_SIDED|95.0|-3.94|4.05||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||4.05|-3.94|0.979
91486981|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.666|||||TWO_SIDED|95.0|0.01|0.9|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.90|0.01|
91678738|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.4||||0.287|TWO_SIDED|95.0|-2.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||6.84|-2.03|0.287
91678739|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.45||||0.125|TWO_SIDED|95.0|-0.96|7.85||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||7.85|-0.96|0.125
91678740|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.15||||0.503|TWO_SIDED|95.0|-4.18|8.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Mental health|||8.49|-4.18|0.503
91678741|NCT02504671|183250068|OTHER||Mean Difference (Net)|5.01||||0.099|TWO_SIDED|95.0|-0.96|10.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24,Mental health|||10.98|-0.96|0.099
91678742|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.88||||0.268|TWO_SIDED|95.0|-1.45|5.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.21|-1.45|0.268
91678743|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.45||||0.147|TWO_SIDED|95.0|-0.87|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.77|-0.87|0.147
91678744|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.87||||0.145|TWO_SIDED|95.0|-0.99|6.73||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||6.73|-0.99|0.145
91678745|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.54||||0.014|TWO_SIDED|95.0|0.97|8.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||8.61|0.97|0.014
91678746|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.47||||0.856|TWO_SIDED|95.0|-4.66|5.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.61|-4.66|0.856
91678747|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.65||||0.793|TWO_SIDED|95.0|-4.24|5.55||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.55|-4.24|0.793
91486982|NCT04823650|182846746|OTHER||Intraclass correlation coefficient|0.346|||||TWO_SIDED|95.0|0.0|0.69|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.69|0.00|
91527565|NCT00077636|182930417|NON_INFERIORITY_OR_EQUIVALENCE|In the analysis based on the standard population, end of treatment virological response was equivalent in the two treatment arms (94% in the 16-week arm and 92% in the 24-week arm).|Odds Ratio (OR)|1.32||||0.1941|TWO_SIDED|95.0|0.86|2.03|||Cochran-Mantel-Haenszel|stratified by country.||||2.03|0.86|0.1941
91678748|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.59||||0.778|TWO_SIDED|95.0|-3.51|4.69||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||4.69|-3.51|0.778
91678749|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.6||||0.773|TWO_SIDED|95.0|-4.7|3.5||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||3.50|-4.70|0.773
91678750|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.08||||0.631|TWO_SIDED|95.0|-3.34|5.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||5.49|-3.34|0.631
91678751|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.68||||0.23|TWO_SIDED|95.0|-1.71|7.07||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||7.07|-1.71|0.230
91678752|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.41||||0.901|TWO_SIDED|95.0|-6.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||6.84|-6.03|0.901
91678753|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.52||||0.412|TWO_SIDED|95.0|-3.54|8.59||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||8.59|-3.54|0.412
91678754|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.88||||0.234|TWO_SIDED|95.0|-1.22|4.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||4.98|-1.22|0.234
91678755|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.66||||0.094|TWO_SIDED|95.0|-0.46|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||5.77|-0.46|0.094
91678756|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.43||||0.423|TWO_SIDED|95.0|-2.08|4.94||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||4.94|-2.08|0.423
91678757|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.35||||0.061|TWO_SIDED|95.0|-0.16|6.86||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||6.86|-0.16|0.061
91486983|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.827|||||TWO_SIDED|95.0|0.53|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.94|0.53|
91486984|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.877|||||TWO_SIDED|95.0|0.66|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.96|0.66|
91486985|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.783|||||TWO_SIDED|95.0|0.17|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.94|0.17|
91678758|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.21||||0.657|TWO_SIDED|95.0|-4.16|6.57||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||6.57|-4.16|0.657
91678759|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.87||||0.737|TWO_SIDED|95.0|-4.22|5.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||5.95|-4.22|0.737
91678760|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.95||||0.165|TWO_SIDED|95.0|-1.22|7.11||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.11|-1.22|0.165
91678761|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.4||||0.109|TWO_SIDED|95.0|-0.77|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.56|-0.77|0.109
91486986|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.833|||||TWO_SIDED|95.0|-0.14|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.97|-0.14|
91486987|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.644|||||TWO_SIDED|95.0|-0.05|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.92|-0.05|
91486988|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.383|||||TWO_SIDED|95.0|-0.06|0.81|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.81|-0.06|
91678762|NCT02504671|183250068|OTHER||Mean Difference (Net)|1.98||||0.359|TWO_SIDED|95.0|-2.26|6.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||6.21|-2.26|0.359
91678763|NCT02504671|183250068|OTHER||Mean Difference (Net)|4.35||||0.043|TWO_SIDED|95.0|0.14|8.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||8.56|0.14|0.043
91678764|NCT02504671|183250068|OTHER||Mean Difference (Net)|-0.33||||0.923|TWO_SIDED|95.0|-7.15|6.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Social Functioning|||6.49|-7.15|0.923
91678765|NCT02504671|183250068|OTHER||Mean Difference (Net)|0.3||||0.927|TWO_SIDED|95.0|-6.11|6.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.70|-6.11|0.927
91678766|NCT02504671|183250068|OTHER||Mean Difference (Net)|4.64||||0.018|TWO_SIDED|95.0|0.82|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||8.46|0.82|0.018
91486989|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.785|||||TWO_SIDED|95.0|-0.02|0.95|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.95|-0.02|
91486990|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.679|||||TWO_SIDED|95.0|-0.06|0.93|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.93|-0.06|
91678767|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.34||||0.087|TWO_SIDED|95.0|-0.49|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Vitality|||7.17|-0.49|0.087
91678768|NCT02504671|183250068|OTHER||Mean Difference (Net)|2.64||||0.193|TWO_SIDED|95.0|-1.35|6.64||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||6.64|-1.35|0.193
91678769|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.97||||0.051|TWO_SIDED|95.0|-0.01|7.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||7.95|-0.01|0.051
91678770|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.36||||0.321|TWO_SIDED|95.0|-3.31|10.02||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Vitality|||10.02|-3.31|0.321
91678771|NCT02504671|183250068|OTHER||Mean Difference (Net)|3.13||||0.328|TWO_SIDED|95.0|-3.18|9.44||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.44|-3.18|0.328
91678772|NCT02504671|183250069|OTHER||Mean Difference (Net)|-0.65||||0.701|TWO_SIDED|95.0|-3.97|2.67||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||2.67|-3.97|0.701
91678773|NCT02504671|183250069|OTHER||Mean Difference (Net)|1.5||||0.37|TWO_SIDED|95.0|-1.79|4.78||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||4.78|-1.79|0.370
91678774|NCT02504671|183250069|OTHER||Mean Difference (Net)|2.55||||0.125|TWO_SIDED|95.0|-0.71|5.81||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||5.81|-0.71|0.125
91678775|NCT02504671|183250069|OTHER||Mean Difference (Net)|1.92||||0.292|TWO_SIDED|95.0|-1.66|5.5||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||5.50|-1.66|0.292
91678776|NCT02504671|183250069|OTHER||Mean Difference (Net)|6.11||||0.163|TWO_SIDED|95.0|-1.04|6.11||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT sscore|||6.11|-1.04|0.163
91678777|NCT02504671|183250069|OTHER||Mean Difference (Net)|3.08||||0.087|TWO_SIDED|95.0|-0.46|6.61||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||6.61|-0.46|0.087
91678778|NCT02504671|183250069|OTHER||Mean Difference (Net)|0.76||||0.808|TWO_SIDED|95.0|-5.4|6.92||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.92|-5.40|0.808
91678779|NCT02504671|183250069|OTHER||Mean Difference (Net)|-0.47||||0.874|TWO_SIDED|95.0|-6.31|5.38||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||5.38|-6.31|0.874
91678780|NCT02504671|183250069|OTHER||Mean Difference (Net)|-0.81||||0.78|TWO_SIDED|95.0|-6.58|4.95||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,FACIT score|||4.95|-6.58|0.780
91678781|NCT02504671|183250069|OTHER||Mean Difference (Net)|3.57||||0.033|TWO_SIDED|95.0|0.29|6.85||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.85|0.29|0.033
91678782|NCT02504671|183250069|OTHER||Mean Difference (Net)|2.81||||0.094|TWO_SIDED|95.0|-0.48|6.1||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.10|-0.48|0.094
91678783|NCT02504671|183250069|OTHER||Mean Difference (Net)|3.92||||0.032|TWO_SIDED|95.0|0.34|7.49||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||7.49|0.34|0.032
91678784|NCT02504671|183250069|OTHER||Mean Difference (Net)|5.33||||0.004|TWO_SIDED|95.0|1.77|8.89||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||8.89|1.77|0.004
91678785|NCT02504671|183250069|OTHER||Mean Difference (Net)|0.73||||0.808|TWO_SIDED|95.0|-5.19|6.64||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.64|-5.19|0.808
91678786|NCT02504671|183250069|OTHER||Mean Difference (Net)|1.87||||0.511|TWO_SIDED|95.0|-3.74|7.48||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||7.48|-3.74|0.511
91678787|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.07||||0.888|TWO_SIDED|95.0|-1.04|0.9||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.90|-1.04|0.888
91678788|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.5||||0.307|TWO_SIDED|95.0|-1.46|0.46||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.46|-1.46|0.307
91678789|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.99||||0.041|TWO_SIDED|95.0|-1.95|-0.04||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.04|-1.95|0.041
91678790|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.64||||0.191|TWO_SIDED|95.0|-1.6|0.32||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||0.32|-1.60|0.191
91678791|NCT02504671|183250070|OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|-2.16|-0.24||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.24|-2.16|0.014
91678792|NCT02504671|183250070|OTHER||Mean Difference (Net)|-1.39||||0.004|TWO_SIDED|95.0|-2.34|-0.45||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.45|-2.34|0.004
91678793|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.36||||0.656|TWO_SIDED|95.0|-1.94|1.23||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.23|-1.94|0.656
91678794|NCT02504671|183250070|OTHER||Mean Difference (Net)|0.07||||0.928|TWO_SIDED|95.0|-1.43|1.57||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.57|-1.43|0.928
91678795|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.2||||0.788|TWO_SIDED|95.0|-1.68|1.28||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.28|-1.68|0.788
91678796|NCT02504671|183250070|OTHER||Mean Difference (Net)|-1.26||||0.01|TWO_SIDED|95.0|-2.22|-0.3||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.30|-2.22|0.010
91678797|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.93||||0.059|TWO_SIDED|95.0|-1.89|0.03||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.03|-1.89|0.059
91678798|NCT02504671|183250070|OTHER||Mean Difference (Net)|-1.44||||0.003|TWO_SIDED|95.0|-2.4|-0.48||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.48|-2.40|0.003
91678799|NCT02504671|183250070|OTHER||Mean Difference (Net)|-1.57||||0.001|TWO_SIDED|95.0|-2.53|-0.62||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.62|-2.53|0.001
91486991|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.405|||||TWO_SIDED|95.0|-0.05|0.83|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.83|-0.05|
91486992|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.257|||||TWO_SIDED|95.0|-0.32|0.69|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.69|-0.32|
91678800|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.76||||0.324|TWO_SIDED|95.0|-2.28|0.76||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.76|-2.28|0.324
91678801|NCT02504671|183250070|OTHER||Mean Difference (Net)|-0.58||||0.432|TWO_SIDED|95.0|-2.02|0.87||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.87|-2.02|0.432
91486993|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.892|||||TWO_SIDED|95.0|0.69|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.96|0.69|
91486994|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.837|||||TWO_SIDED|95.0|0.47|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.95|0.47|
91678802|NCT04280705|183250077|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.49|||Log Rank|||||1.49|1.12|<0.001
91678803|NCT04280705|183250101|SUPERIORITY|||||||0.058|||||||Barnard's Exact Test|||||||0.058
91678804|NCT04280705|183250102|SUPERIORITY|||||||0.01|||||||Barnard's Exact Test|||||||0.010
91678805|NCT04280705|183250114|SUPERIORITY||Cox Proportional Hazard|1.23||||0.002|TWO_SIDED|95.0|1.08|1.41|||Log Rank|||||1.41|1.08|0.002
91678806|NCT04280705|183250115|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.48|||Log Rank|||||1.48|1.12|<0.001
91486995|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.341|||||TWO_SIDED|95.0|-0.13|0.8|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.80|-0.13|
91486996|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.536|||||TWO_SIDED|95.0|-0.05|0.88|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.88|-0.05|
91486997|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.264|||||TWO_SIDED|95.0|-0.03|0.71|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.71|-0.03|
91678807|NCT04280705|183250116|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.001|TWO_SIDED|95.0|1.1|1.46|||Log Rank|||||1.46|1.10|<0.001
91678808|NCT04280705|183250117|SUPERIORITY||Cox Proportional Hazard|1.07|||||TWO_SIDED|95.0|0.73|1.58||||||This analysis is for Asian participants||1.58|0.73|
91678809|NCT04280705|183250117|SUPERIORITY||Cox Proportional Hazard|1.25|||||TWO_SIDED|95.0|0.91|1.72||||||This analysis is for Black or African American participants||1.72|0.91|
91678810|NCT04280705|183250117|SUPERIORITY||Cox Proportional Hazard|1.29|||||TWO_SIDED|95.0|1.06|1.57||||||This analysis is for White participants||1.57|1.06|
91678811|NCT04280705|183250117|SUPERIORITY||Cox Proportional Hazard|1.68|||||TWO_SIDED|95.0|1.1|2.58||||||This analysis is for Race of Other participants||2.58|1.10|
91678812|NCT04280705|183250118|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.1|1.55||||||This analysis is for Not Hispanic or Latino participants||1.55|1.10|
91678813|NCT04280705|183250118|SUPERIORITY||Cox Proportional Hazard|1.28|||||TWO_SIDED|95.0|0.94|1.73||||||This analysis is for Hispanic or Latino participants||1.73|0.94|
91678814|NCT04280705|183250119|SUPERIORITY||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||This analysis is for Male participants||1.56|1.09|
91678815|NCT04280705|183250119|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.03|1.66||||||This analysis is for Female participants||1.66|1.03|
91678816|NCT03222583|183250127|NON_INFERIORITY|The percentage of participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 96% if the lower confidence bound (LCB) of the 2-sided 95% confidence interval (CI) for the percentage was \> 90%.|Percentage of Participants with SVR12|97.2|||||TWO_SIDED|95.0|95.5|98.9||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||98.9|95.5|
91678817|NCT03222583|183250128|NON_INFERIORITY|The percentage of GT1-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 97% if the LCB of the 2-sided 95% CI for the percentage was \> 91%.|Percentage of Participants with SVR12|99.4|||||TWO_SIDED|95.0|98.3|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|98.3|
91678818|NCT03222583|183250129|NON_INFERIORITY|The percentage of GT2-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 95% if the LCB of the 2-sided 95% CI for the percentage was \> 89%.|Percentage of Participants with SVR12|97.8|||||TWO_SIDED|95.0|95.4|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|95.4|
91678819|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.46|1.6||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.60|1.46|< 0.0001
91678820|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.36|0.58||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||0.58|0.36|<0.0001
91678821|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|1.71|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.65|1.78||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.78|1.65|<0.0001
91678822|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|1.76|1.87||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.87|1.76|<0.0001
91678823|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.42|0.64||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||0.64|0.42|<0.0001
91678824|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|2.03|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.95|2.11||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||2.11|1.95|<0.0001
91678825|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.56|2.72||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||2.72|2.56|<0.0001
91692377|NCT02770170|183279666|OTHER|||||||0.7367||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7367
91692378|NCT02770170|183279666|OTHER|||||||0.6624||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod exponential model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6624
91486998|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.275|||||TWO_SIDED|95.0|-0.08|0.66|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.66|-0.08|
91486999|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.631|||||TWO_SIDED|95.0|-0.05|0.92|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.92|-0.05|
91678826|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|1.68|1.96||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.96|1.68|<0.0001
91678827|NCT03986138|183250139|SUPERIORITY||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.26|2.41||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||2.41|2.26|<0.0001
91678828|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.05|0.05||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.05|-0.05|<0.0001
91678829|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.05|0.1||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.10|-0.05|<0.0001
91678830|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.1|0.01||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.01|-0.10|<0.0001
91678831|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.06|0.05|||t-test, 2 sided|||Criterion: Internal morphology; Reader 1||0.05|-0.06|<0.0001
91678832|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.07|0.07|||t-test, 2 sided|||Criterion: Internal morphology; Reader 2||0.07|-0.07|<0.0001
91678833|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.08|0.02|||t-test, 2 sided|||Criterion: Internal morphology; Reader 3||0.02|-0.08|<0.0001
91678834|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.06|0.09|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1||0.09|-0.06|<0.0001
91678835|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.07|0.12|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2||0.12|-0.07|<0.0001
91678836|NCT03986138|183250140|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.08|0.04|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3||0.04|-0.08|<0.0001
91678837|NCT03182244|183250155|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.00152|TWO_SIDED|95.0|0.451|0.832|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per interactive response technology (IRT).|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.832|0.451|0.00152
91487000|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.379|||||TWO_SIDED|95.0|-0.03|0.81|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.81|-0.03|
91678838|NCT03182244|183250156|SUPERIORITY||Hazard Ratio (HR)|0.589||||5e-05|TWO_SIDED|95.0|0.438|0.792|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.792|0.438|0.00005
91678839|NCT03182244|183250157|SUPERIORITY||Treatment difference|8.9||||0.04256|TWO_SIDED|95.0|0.3|17.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||17.5|0.3|0.04256
91678840|NCT03182244|183250158|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.8871|TWO_SIDED|95.0|0.131|10.338|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||10.338|0.131|0.88710
91678841|NCT03182244|183250159|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.55969|TWO_SIDED|95.0|0.209|2.414|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||2.414|0.209|0.55969
91678842|NCT03182244|183250160|SUPERIORITY||Hazard Ratio (HR)|1.583||||0.66261|TWO_SIDED|95.0|0.192|13.048|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||13.048|0.192|0.66261
91678843|NCT03182244|183250161|SUPERIORITY||Hazard Ratio (HR)|0.756||||0.55731|TWO_SIDED|95.0|0.286|1.999|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.999|0.286|0.55731
91487001|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.606|||||TWO_SIDED|95.0|0.11|0.86|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.86|0.11|
91678844|NCT03182244|183250162|SUPERIORITY||Treatment difference|17.7||||0.00049|TWO_SIDED|95.0|7.9|27.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||27.5|7.9|0.00049
91678845|NCT03182244|183250164|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.56944|TWO_SIDED|95.0|0.494|1.487|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.487|0.494|0.56944
91678846|NCT03182244|183250165|SUPERIORITY||Treatment difference|31.2|||<|1e-05|TWO_SIDED|95.0|20.2|42.3|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||42.3|20.2|<0.00001
91678847|NCT03182244|183250171|SUPERIORITY||Treatment difference|14.7||||0.00055|TWO_SIDED|95.0|6.5|22.8|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||22.8|6.5|0.00055
91678848|NCT03182244|183250172|SUPERIORITY||Least square mean difference|0.6||||0.14841||||||Analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. LS Mean difference was estimated using chemotherapy as control.|ANCOVA|||||||0.14841
91678849|NCT04709835|183250200|SUPERIORITY||Difference in Adjusted Means|-0.11|STANDARD_ERROR_OF_MEAN|0.292||0.7144|TWO_SIDED|80.0|-0.49|0.27|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.27|-0.49|0.7144
91678850|NCT04709835|183250200|SUPERIORITY||Difference in Adjusted Means|0.32|STANDARD_ERROR_OF_MEAN|0.327||0.3373|TWO_SIDED|80.0|-0.11|0.74|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.74|-0.11|0.3373
91678851|NCT04709835|183250200|SUPERIORITY||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.315||0.426|TWO_SIDED|80.0|-0.66|0.16|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.16|-0.66|0.4260
91678852|NCT04709835|183250201|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|80.0|0.53|1.74|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.74|0.53|
91487002|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.714|||||TWO_SIDED|95.0|0.29|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.90|0.29|
91678853|NCT04709835|183250201|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|80.0|0.76|2.32|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.32|0.76|
91678854|NCT04709835|183250202|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|80.0|0.44|1.7|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.70|0.44|
91678855|NCT04709835|183250202|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|80.0|0.56|2.03|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.03|0.56|
91487003|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.39|||||TWO_SIDED|95.0|-0.2|0.78|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.78|-0.20|
91487004|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.703|||||TWO_SIDED|95.0|0.23|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.90|0.23|
91487005|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.555|||||TWO_SIDED|95.0|0.0|0.84|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.84|0.00|
91487006|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.563|||||TWO_SIDED|95.0|0.03|0.84|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.84|0.03|
91487007|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.687|||||TWO_SIDED|95.0|0.2|0.9|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.90|0.20|
91487008|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.603|||||TWO_SIDED|95.0|0.04|0.87|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.87|0.04|
91487009|NCT04823650|182846747|OTHER||Intraclass correlation coefficient|0.459|||||TWO_SIDED|95.0|-0.02|0.79|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.79|-0.02|
91487010|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.569|||||TWO_SIDED|95.0|-0.19|0.87|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.87|-0.19|
91487011|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.612|||||TWO_SIDED|95.0|-0.11|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.91|-0.11|
91678856|NCT04709835|183250203|SUPERIORITY||Difference in Percentage of Positivity|5.0|||||TWO_SIDED|80.0|-0.16|10.16|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||10.16|-0.16|
91678857|NCT04709835|183250203|SUPERIORITY||Difference in Percentage of Positivity|-1.9|||||TWO_SIDED|80.0|-9.2|5.41|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||5.41|-9.20|
91487012|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.444|||||TWO_SIDED|95.0|-0.06|0.85|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.85|-0.06|
91678858|NCT04709835|183250203|SUPERIORITY||Difference in Percentage of Positivity|5.79|||||TWO_SIDED|80.0|-4.82|16.4|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||16.40|-4.82|
91487013|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.254|||||TWO_SIDED|95.0|-0.35|0.7|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.70|-0.35|
91487014|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.875|||||TWO_SIDED|95.0|0.66|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.96|0.66|
91487015|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.793|||||TWO_SIDED|95.0|0.02|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.95|0.02|
91487016|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.467|||||TWO_SIDED|95.0|0.08|0.78|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.78|0.08|
91487017|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.705|||||TWO_SIDED|95.0|-0.08|0.94|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.94|-0.08|
91487018|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.585|||||TWO_SIDED|95.0|-0.05|0.9|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.90|-0.05|
91678859|NCT04709835|183250203|SUPERIORITY||Difference in Percentage of Positivity|-0.88|||||TWO_SIDED|80.0|-12.4|10.65|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||10.65|-12.40|
91678860|NCT04709835|183250203|SUPERIORITY||Difference in Percentage of Positivity|2.39|||||TWO_SIDED|80.0|-10.64|15.42|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||15.42|-10.64|
91678861|NCT04709835|183250203|SUPERIORITY||Difference in Percentage of Positivity|-0.26|||||TWO_SIDED|80.0|-13.39|12.88|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||12.88|-13.39|
91487019|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.558|||||TWO_SIDED|95.0|-0.15|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.90|-0.15|
91487020|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.486|||||TWO_SIDED|95.0|-0.15|0.87|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.87|-0.15|
91487021|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.222|||||TWO_SIDED|95.0|-0.04|0.68|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.68|-0.04|
91526779|NCT01598298|182929043|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.||-0.40|-1.24|0.0002
91678862|NCT04709835|183250215|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.294||0.7351|TWO_SIDED|80.0|-0.48|0.28|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.28|-0.48|0.7351
91678863|NCT04709835|183250215|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7524|TWO_SIDED|80.0|-0.5|0.3|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.30|-0.50|0.7524
91678864|NCT04709835|183250215|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.314||0.8083|TWO_SIDED|80.0|-0.48|0.33|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.33|-0.48|0.8083
91678865|NCT03347422|183250230|SUPERIORITY||Odds Ratio (OR)|15.94|||<|0.001|TWO_SIDED|95.0|2.88|88.04||Threshold for significance was 0.05.|Cochran-Mantel-Haenszel||Stratified by baseline hemoglobin (\< median versus \>=median) and geographic region (Asia/Other, North America, and Europe).|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||88.04|2.88|<0.001
91678866|NCT03347422|183250232|SUPERIORITY||LS mean difference|2.56|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|TWO_SIDED|95.0|1.75|3.38||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||3.38|1.75|<0.001
91678867|NCT03347422|183250233|SUPERIORITY||LS mean difference|8.93|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|4.0|13.85||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||13.85|4.00|<0.001
91487022|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.729|||||TWO_SIDED|95.0|0.31|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.91|0.31|
91678868|NCT02633488|183250275|EQUIVALENCE|equivalence defined as less that 2 SD in FMD between 2 treatments|||||>|0.05||||||FMD % change exceeded the threshold of our statistical significance test, i.e. the null hypothesis that there was no effect of metformin remained tenable.|t-test, 2 sided|||||||>0.05
91678869|NCT01383135|183250301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||GraphPad (GraphPad Software, San Diego, Calif) was used for the paired two-sample t test and was performed to compare SUVmax values. P \< .05 was considered to indicate a significant difference|t-test, 2 sided|||Comparison made between baseline tumor values and tumor values 6-weeks post-bevacizumab therapy||||.034
91487023|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.727|||||TWO_SIDED|95.0|0.2|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.91|0.20|
91678870|NCT03397771|183250319|OTHER||Odds Ratio (OR)|1.0||||0.963|TWO_SIDED||||||Regression, Logistic|||||||0.963
91678871|NCT03397771|183250320|NON_INFERIORITY|The analysis was conducted according to the nul hypothesis, assuming no difference between treatment arms||||||0.022|||||||ANCOVA|||||||0.022
91678872|NCT02605993|183250374|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|Mixed Model for Repeated Measures (MMRM)|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 253 for Cohorts 1 to 4, with an estimated standard deviation (SD) of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
91692379|NCT02770170|183279666|OTHER||Risk Difference (RD)|-10.0||||0.4645|TWO_SIDED|80.0|-27.292|7.288|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||7.288|-27.292|0.4645
91717533|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.519|TWO_SIDED|95.0|-6.5|14.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||14.3|-6.5|0.519
91717534|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Difference in percentage|-0.8||||0.766|TWO_SIDED|95.0|-10.1|8.5||The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.5|-10.1|0.766
91487024|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.592|||||TWO_SIDED|95.0|-0.19|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.91|-0.19|
91487025|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.624|||||TWO_SIDED|95.0|-0.1|0.9|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.90|-0.10|
91487026|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.669|||||TWO_SIDED|95.0|-0.1|0.92|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.92|-0.10|
91487027|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.376|||||TWO_SIDED|95.0|-0.04|0.81|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.81|-0.04|
91487028|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.755|||||TWO_SIDED|95.0|0.26|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.92|0.26|
91678873|NCT02605993|183250374|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 281 for Cohort 4 only, with an estimated SD of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
91678874|NCT02605993|183250375|OTHER|||||||0.0214||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0214
91487029|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.614|||||TWO_SIDED|95.0|0.05|0.87|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.87|0.05|
91678875|NCT02605993|183250375|OTHER|||||||0.0313||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.0313
91678876|NCT02605993|183250376|OTHER|||||||0.0625||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||tatistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0625
91487030|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.424|||||TWO_SIDED|95.0|-0.18|0.83|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.83|-0.18|
91487031|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.648|||||TWO_SIDED|95.0|0.06|0.89|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.89|0.06|
91487032|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.586|||||TWO_SIDED|95.0|-0.07|0.86|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.86|-0.07|
91487033|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.759|||||TWO_SIDED|95.0|0.38|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.92|0.38|
91678877|NCT02605993|183250376|OTHER|MMRM||||||0.5||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.||||0.5000
91678878|NCT02605993|183250377|OTHER|||||||0.4871||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.4871
91678879|NCT02605993|183250377|OTHER|||||||0.4688||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.4688
91678880|NCT02605993|183250378|OTHER|||||||0.0023||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0023
91487034|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.692|||||TWO_SIDED|95.0|0.01|0.91|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.91|0.01|
91678881|NCT02605993|183250379|OTHER|||||||0.0029||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0029
91678882|NCT02605993|183250379|OTHER|||||||0.125||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.1250
91678883|NCT03493386|183250383|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC (0-t)|||1.07|0.97|
91678884|NCT03493386|183250383|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC(0-inf)|||1.07|0.97|
91678885|NCT03493386|183250384|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Cmax|||1.12|0.97|
91678886|NCT03493386|183250391|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-t)|||1.01|0.82|
91678887|NCT03493386|183250391|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-inf)|||1.01|0.82|
91678888|NCT03493386|183250392|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geomtric mean|0.89||||||90.0|0.73|1.08||||||||1.08|0.73|
91678889|NCT00988442|183250447|SUPERIORITY_OR_OTHER|||||||1||||||Two-sided 5% significance level.|Fisher Exact|||A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.||||1.000
91678890|NCT00271154|183250475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.||||<0.0001
91717535|NCT02557399|183327770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.666|TWO_SIDED|95.0|-5.8|10.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||10.5|-5.8|0.666
91717536|NCT02557399|183327774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
91678891|NCT00271154|183250476|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group||||0.10
91717537|NCT02557399|183327774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
91487035|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.614|||||TWO_SIDED|95.0|-0.08|0.89|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.89|-0.08|
91487036|NCT04823650|182846748|OTHER||Intraclass correlation coefficient|0.605|||||TWO_SIDED|95.0|-0.11|0.9|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.90|-0.11|
91678892|NCT04620135|183250477|SUPERIORITY||The least squares (LS) mean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.221|<|1e-05|TWO_SIDED|95.0|-2.17|-1.31||Analyzed as ANCOVA with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with MCMC and regression-based multiple imputation to impute missing data.|ANCOVA||||The primary analysis of the primary endpoint employed an analysis of covariance (ANCOVA) with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with Markov Chain Monte Carlo (MCMC) and regression based multiple imputation (MI) techniques to impute missing data. The least squares (LS) mean difference (netarsudil - ripasudil) was presented with a 2-sided p-value and 95% confidence intervals (CIs). A success criterion for the superiority of netarsudil to ripasudil was defined as the 2-sided p value ≤ 0.05 for testing the difference (netarsudil QD - ripasudil BID) to 0 and the point estimate of the LS mean difference of \< 0.|-1.31|-2.17|<0.00001
91678893|NCT01442688|183250481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.995|1.04|||ANOVA|||||1.04|0.995|
91678894|NCT01442688|183250482|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.94|1.04|||ANOVA|||||1.04|0.940|
91717538|NCT02557399|183327774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.024|TWO_SIDED|95.0|-0.41|-0.03|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.03|-0.41|0.024
91717539|NCT02557399|183327774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.08|TWO_SIDED|95.0|-0.36|0.02|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.02|-0.36|0.080
91717540|NCT00490919|183327810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.225||0.0104|TWO_SIDED|95.0|-1.02|-0.14|||Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Double-blind analysis (comparison between BTDS and placebo TDS) at week 12 of the double-blind phase.|Missing average pain over the last 24 hours scores after treatment discontinuation were imputed using BOCF for adverse event-related withdrawals and LOCF for withdrawals due to other reasons.||-0.14|-1.02|.0104
91717541|NCT00490919|183327811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0874||0.1586|TWO_SIDED|95.0|-0.296|0.048||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||Mean comparison from weeks 2-12 of the double-blind phase.|||0.048|-0.296|.1586
91717542|NCT00490919|183327812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.605||0.0062|TWO_SIDED|95.0|-7.55|-1.25||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Treatment comparison over Weeks 4, 8, and 12.|The primary comparison between groups was based on estimates and contrasts for the weeks 4, 8, and 12 mean values.||-1.25|-7.55|.0062
91717543|NCT02100124|183327814|SUPERIORITY||Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.56|1.36|||Regression, Logistic|||||1.36|0.56|1.0
91717544|NCT02100124|183327814|SUPERIORITY||Odds Ratio (OR)|1.13||||1|TWO_SIDED|95.0|0.7|1.83|||Regression, Logistic|||||1.83|0.70|1.0
91717545|NCT02100124|183327814|SUPERIORITY||Odds Ratio (OR)|1.3||||0.53|TWO_SIDED|95.0|0.82|2.08|||Regression, Logistic|||||2.08|0.82|0.53
91717546|NCT02100124|183327815|SUPERIORITY||Odds Ratio (OR)|0.88||||0.48|TWO_SIDED|95.0|0.71|1.09|||Regression, Logistic|||||1.09|0.71|0.48
91717547|NCT02100124|183327815|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||||1.35|0.87|1.0
91717548|NCT02100124|183327815|SUPERIORITY||Odds Ratio (OR)|1.23||||0.07|TWO_SIDED|95.0|0.99|1.53|||Regression, Logistic|||||1.53|0.99|0.07
91527566|NCT00077636|182930418|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.65||||0.0003|TWO_SIDED|95.0|0.52|0.82|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.82|0.52|0.0003
91717549|NCT02100124|183327816|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.84|1.29|||Regression, Logistic|||||1.29|0.84|1.0
91717550|NCT02100124|183327816|SUPERIORITY||Odds Ratio (OR)|1.02||||1|TWO_SIDED|95.0|0.82|1.26|||Regression, Logistic|||||1.26|0.82|1.0
91717551|NCT02100124|183327816|SUPERIORITY||Odds Ratio (OR)|0.98||||1|TWO_SIDED|95.0|0.79|1.22|||Regression, Logistic|||||1.22|0.79|1.0
91717552|NCT02100124|183327817|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|95.0|0.83|1.37|||Regression, Logistic|||||1.37|0.83|1.0
91717553|NCT02100124|183327817|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.81|1.33|||Regression, Logistic|||||1.33|0.81|1.0
91717554|NCT02100124|183327817|SUPERIORITY||Odds Ratio (OR)|0.97||||1|TWO_SIDED|95.0|0.75|1.25|||Regression, Logistic|||||1.25|0.75|1.0
91717555|NCT04350827|183327818|SUPERIORITY|||||||0.433|||||||ANOVA|||||||0.433
91717556|NCT00737178|183327834|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<.01
91717557|NCT00737178|183327836|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Chi-squared|||||||0.24
91717558|NCT02034006|183327837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.37|||<|0.0001|TWO_SIDED|95.0|23.44|223.42|||Regression, Logistic|||Presence vs. absence of active leakage.||223.42|23.44|<0.0001
91717559|NCT02034006|183327843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.33|||<|0.0001|TWO_SIDED|95.0|3.18|27.36|||Regression, Logistic|||Presence vs. absence of macular edema.||27.36|3.18|<0.0001
91717560|NCT02034006|183327844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.66|||<|0.0001|TWO_SIDED|95.0|3.76|42.67|||Regression, Logistic|||Presence vs. absence of cysts.||42.67|3.76|<0.0001
91717561|NCT02034006|183327845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.8|||<|0.0001|TWO_SIDED|95.0|11.62|213.5|||Regression, Logistic|||Presence vs. absence of intra-retinal fluid.||213.50|11.62|<0.0001
91717562|NCT02034006|183327846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.1514|TWO_SIDED|95.0|0.99|1.0|||Regression, Logistic|||Change in Central subfield thickness vs previous visit.||1.00|0.99|0.1514
91717563|NCT02034006|183327847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.1265|TWO_SIDED|95.0|0.0|5.63|||Regression, Logistic|||Change in Central subfield volume vs previous visit.||5.63|0.00|0.1265
91717564|NCT02034006|183327849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.91||||0.0103|TWO_SIDED|95.0|1.58|30.23|||Regression, Logistic|||Presence vs. absence of clinically significant abnormalities.||30.23|1.58|0.0103
91717565|NCT02034006|183327850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0854|TWO_SIDED|95.0|0.9|5.33|||Regression, Logistic|||Gain \< 5 letters vs. Gain \>= 5 letters.||5.33|0.90|0.0854
91717566|NCT02034006|183327851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52||||0.0114|TWO_SIDED|95.0|1.23|5.17|||Regression, Logistic|||Gain \< 10 letters vs. Gain \>= 10 letters.||5.17|1.23|0.0114
91717567|NCT02034006|183327852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.0049|TWO_SIDED|95.0|0.25|0.91|||Regression, Logistic|||Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.||0.91|0.25|0.0049
91717568|NCT02034006|183327852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.0461|TWO_SIDED|95.0|0.69|44.52|||Regression, Logistic|||Change from baseline in BCVA: Worsened vs. No change||44.52|0.69|0.0461
91487037|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.985|||||TWO_SIDED|95.0|0.94|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||1.00|0.94|
91678895|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.17|1.88|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.88|1.17|
91678896|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.35|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.35|0.91|
91678897|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.93|3.74|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.74|1.93|
91678898|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.55|2.63|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.63|1.55|
91678899|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.0|||||TWO_SIDED|95.0|2.21|4.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||4.13|2.21|
91678900|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.07|2.18|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.18|1.07|
91678901|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.36|2.97|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.||2.97|1.36|
91487038|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.976|||||TWO_SIDED|95.0|0.72|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.99|0.72|
91692380|NCT02770170|183279666|OTHER||Risk Difference (RD)|-3.38||||0.8084|TWO_SIDED|80.0|-21.204|14.451|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||14.451|-21.204|0.8084
91692381|NCT02770170|183279666|OTHER||Risk Difference (RD)|-3.77||||0.7398|TWO_SIDED|80.0|-18.364|10.832|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||10.832|-18.364|0.7398
91527567|NCT01976364|182930433|OTHER||Least Squares (LS) Mean difference|0.0255|||||TWO_SIDED|95.0|-0.0513|0.1022||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1022|-0.0513|
91692382|NCT02770170|183279667|OTHER||Risk Difference (RD)|-8.93||||0.5773|TWO_SIDED|80.0|-23.66|7.64|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.64|-23.66|0.5773
91487039|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.973|||||TWO_SIDED|95.0|-0.01|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||1.00|-0.01|
91487040|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.984|||||TWO_SIDED|95.0|0.95|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|0.95|
91487041|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.963|||||TWO_SIDED|95.0|0.75|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|0.75|
91487042|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.945|||||TWO_SIDED|95.0|-0.16|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|-0.16|
91527568|NCT01976364|182930434|OTHER||LS mean difference|0.091|||||TWO_SIDED|95.0|-0.131|0.313||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.313|-0.131|
91678902|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.73|1.33|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.33|0.73|
91678903|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.42|2.5|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.50|1.42|
91678904|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.43|2.2|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.20|1.43|
91678905|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.17|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.17|
91678906|NCT00546572|183250488|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.7|||||TWO_SIDED|95.0|2.69|5.09|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.09|2.69|
91678907|NCT00546572|183250489|SUPERIORITY_OR_OTHER||difference in proportions|43.8|||||TWO_SIDED|95.0|37.4|49.9|||||Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC - 23vPS expressed as a percentage.|"Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was \> 0."||49.9|37.4|
91678908|NCT00546572|183250490|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|9.6|||||TWO_SIDED|95.0|7.0|13.26|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|"Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||13.26|7.00|
91692383|NCT02770170|183279667|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.59|29.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||29.03|-4.59|0.4013
91692384|NCT02770170|183279667|OTHER||Risk Difference (RD)|-2.5||||0.8965|TWO_SIDED|80.0|-15.98|11.1|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||11.10|-15.98|0.8965
91692385|NCT02770170|183279668|OTHER||Risk Difference (RD)|-19.64||||0.1476|TWO_SIDED|80.0|-35.38|-2.48|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-2.48|-35.38|0.1476
91487043|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.985|||||TWO_SIDED|95.0|0.96|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.99|0.96|
91692386|NCT02770170|183279668|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.2|26.86|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||26.86|-4.20|0.4013
91717569|NCT02470741|183327860|SUPERIORITY||Mean Difference (Net)|-11.85||||0.24|TWO_SIDED|95.0|-32.92|9.23|||Mixed Models Analysis|Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|Null hypotheses: Letrozole is not associated with an improvement in the UFSQOL Overall Score.||9.23|-32.92|0.24
91717570|NCT00485836|183327861|SUPERIORITY_OR_OTHER||Difference in Least Squares means|11.5|||<|0.0001||95.0|7.7|15.3||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||15.3|7.7|<0.0001
91717571|NCT00485836|183327861|SUPERIORITY_OR_OTHER||Difference in Least Squares means|13.8|||<|0.0001||95.0|10.3|17.4||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||17.4|10.3|<0.0001
91717572|NCT00485836|183327862|SUPERIORITY_OR_OTHER||Difference in percentage|29.3|||<|0.0001||95.0|18.8|39.7|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||39.7|18.8|<0.0001
91717573|NCT00485836|183327862|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001||95.0|19.6|40.9|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||40.9|19.6|<0.0001
91717574|NCT00485836|183327863|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.0019||95.0|4.3|18.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||18.2|4.3|0.0019
91717575|NCT00485836|183327863|SUPERIORITY_OR_OTHER||Difference in percentage|13.6|||<|0.0001||95.0|7.2|20.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||20.1|7.2|<0.0001
91717576|NCT00485836|183327864|SUPERIORITY_OR_OTHER||Difference in percentage|51.9|||<|0.0001||95.0|41.6|62.3|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||62.3|41.6|<0.0001
91717577|NCT00485836|183327864|SUPERIORITY_OR_OTHER||Difference in percentage|54.0|||<|0.0001||95.0|44.0|64.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||64.1|44.0|<0.0001
91717578|NCT00485836|183327865|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-272.2|||<|0.0001||95.0|-329.9|-214.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-214.5|-329.9|<0.0001
91717579|NCT00485836|183327865|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-283.8|||<|0.0001||95.0|-337.8|-229.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-229.8|-337.8|<0.0001
91717580|NCT00485836|183327866|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.8||||0.0019||95.0|2.1|9.4|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.4|2.1|0.0019
91717581|NCT00485836|183327866|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.9||||0.0099||95.0|1.2|8.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||8.6|1.2|0.0099
91717582|NCT00485836|183327867|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.3||||0.0002||95.0|3.1|9.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||9.5|3.1|0.0002
91717583|NCT00485836|183327867|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0199||95.0|0.7|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.6|0.7|0.0199
91717584|NCT01898078|183327877|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.||1.12|0.85|
91717585|NCT01898078|183327878|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.16|||||TWO_SIDED|90.0|1.01|1.34|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.||1.34|1.01|
91487044|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.974|||||TWO_SIDED|95.0|0.91|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.99|0.91|
91487045|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.968|||||TWO_SIDED|95.0|0.47|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.99|0.47|
91678909|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.1|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 1: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.10|0.85|
91678910|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 3: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.11|0.91|
91678911|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.68|0.92|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 4: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.92|0.68|
91678912|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.73|0.94|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 5: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.94|0.73|
91678913|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.4|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.40|1.03|
91678914|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.02|1.35|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6B: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.35|1.02|
91678915|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.65|1.01|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 7F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.01|0.65|
91678916|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 9V: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
91678917|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.05|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 14: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.05|0.79|
91678918|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.97|1.23|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 18C: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.23|0.97|
91678919|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.07|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.07|0.89|
91678920|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.83|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.83|
91487046|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|-0.019|||||TWO_SIDED|95.0|-0.39|0.45|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.45|-0.39|
91487047|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.977|||||TWO_SIDED|95.0|-0.07|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||1.00|-0.07|
91678921|NCT00546572|183250491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.14|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 23F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||2.14|1.60|
91678922|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.1|1.76|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.76|1.10|
91678923|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.34|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.34|0.91|
91678924|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.3|||||TWO_SIDED|95.0|1.66|3.25|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.25|1.66|
91678925|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.21|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.21|
91678926|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|3.8|||||TWO_SIDED|95.0|2.78|5.07|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.07|2.78|
91678927|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.8|1.67|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.67|0.80|
91678928|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.18|2.62|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.62|1.18|
91678929|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.62|1.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.13|0.62|
91692387|NCT02770170|183279668|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-13.63|13.63|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||13.63|-13.63|
91692388|NCT02770170|183279669|OTHER||Risk Difference (RD)|-26.67||||0.0512|TWO_SIDED|80.0|-41.52|-9.42|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-9.42|-41.52|0.0512
91692389|NCT02770170|183279669|OTHER||Risk Difference (RD)|5.0||||0.7597|TWO_SIDED|80.0|-12.1|20.74|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||20.74|-12.10|0.7597
91692390|NCT02770170|183279669|OTHER||Risk Difference (RD)|-5.0||||0.7505|TWO_SIDED|80.0|-18.74|9.02|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||9.02|-18.74|0.7505
91692391|NCT02770170|183279670|OTHER||Risk Difference (RD)|-21.43||||0.1269|TWO_SIDED|80.0|-36.03|-4.41|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-4.41|-36.03|0.1269
91717586|NCT01898078|183327879|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.15|||||TWO_SIDED|90.0|0.96|1.39|||||Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean||1.39|0.96|
91717587|NCT02351934|183327895|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.564
91717588|NCT02351934|183327896|SUPERIORITY|||||||0.675|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.675
91717589|NCT02351934|183327897|SUPERIORITY|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.125
91717590|NCT02351934|183327899|SUPERIORITY|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.595
91717591|NCT02351934|183327900|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.985
91717592|NCT01115452|183327917|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.32||||0.9347|TWO_SIDED|95.0|-8.14|7.5||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis was no difference between treatments.||7.50|-8.14|0.9347
91717593|NCT01115452|183327918|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02||||0.9963|TWO_SIDED|95.0|-8.2|8.24||Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.24|-8.20|0.9963
91717594|NCT01115452|183327918|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.3582|TWO_SIDED|95.0|-4.45|12.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.25|-4.45|0.3582
91717595|NCT01115452|183327918|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.88||||0.36|TWO_SIDED|95.0|-4.46|12.22||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.22|-4.46|0.3600
91717596|NCT01115452|183327919|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91||||0.8265|TWO_SIDED|95.0|-9.13|7.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.30|-9.13|0.8265
91717597|NCT01115452|183327919|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9||||0.8314|TWO_SIDED|95.0|-9.25|7.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.45|-9.25|0.8314
91487048|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.886|||||TWO_SIDED|95.0|-0.21|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.98|-0.21|
91717598|NCT01115452|183327919|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01||||0.9978|TWO_SIDED|95.0|-8.33|8.35||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.35|-8.33|0.9978
91717599|NCT01115452|183327920|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22||||0.3122|TWO_SIDED|95.0|-4.0|12.44|||ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.44|-4.00|0.3122
91717600|NCT01115452|183327920|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.7646|TWO_SIDED|95.0|-9.62|7.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.08|-9.62|0.7646
91678930|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.53|2.69|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.69|1.53|
91678931|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.37|2.1|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.10|1.37|
91678932|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|1.93|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.93|1.09|
91678933|NCT00546572|183250492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|7.3|||||TWO_SIDED|95.0|5.36|9.82|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||9.82|5.36|
91678934|NCT00546572|183250493|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|12.1|||||TWO_SIDED|95.0|8.92|16.44|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|"Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||16.44|8.92|
91678935|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||<|0.001|TWO_SIDED|95.0|-17.3|-5.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.6|-17.3|<0.001
91678936|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.129|TWO_SIDED|95.0|-9.1|1.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.1|-9.1|0.129
91678937|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-6.8||||0.002|TWO_SIDED|95.0|-11.3|-2.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.3|-11.3|0.002
91678938|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-3.2||||0.028|TWO_SIDED|95.0|-6.3|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-6.3|0.028
91678939|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-12.7|||<|0.001|TWO_SIDED|95.0|-18.5|-7.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-7.0|-18.5|<0.001
91678940|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-5.1||||0.048|TWO_SIDED|95.0|-10.2|-0.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-10.2|0.048
91678941|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||<|0.001|TWO_SIDED|95.0|-14.2|-5.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.1|-14.2|<0.001
91678942|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-4.8|||<|0.001|TWO_SIDED|95.0|-7.9|-2.7|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.7|-7.9|<0.001
91678943|NCT00546572|183250494|SUPERIORITY_OR_OTHER||Chan & Zhang|-6.8||||0.062|TWO_SIDED|95.0|-14.0|0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||0.4|-14.0|0.062
91678944|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.284|TWO_SIDED|95.0|-11.3|3.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||3.3|-11.3|0.284
91692392|NCT02770170|183279670|OTHER||Risk Difference (RD)|5.0||||0.7889|TWO_SIDED|80.0|-12.24|21.62|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||21.62|-12.24|0.7889
91717601|NCT01115452|183327920|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.49||||0.1957||95.0|-13.83|2.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.85|-13.83|0.1957
91717602|NCT01115452|183327921|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.35||||0.7472|TWO_SIDED|95.0|-9.62|6.92||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.92|-9.62|0.7472
91678945|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-16.1|||<|0.001|TWO_SIDED|95.0|-21.7|-10.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-10.6|-21.7|<0.001
91678946|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-0.9||||0.539|TWO_SIDED|95.0|-3.5|1.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.4|-3.5|0.539
91678947|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-17.1|||<|0.001|TWO_SIDED|95.0|-23.1|-11.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-11.1|-23.1|<0.001
91678948|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-14.9|||<|0.001|TWO_SIDED|95.0|-20.8|-9.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-9.0|-20.8|<0.001
91678949|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.02|TWO_SIDED|95.0|-4.8|-0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.4|-4.8|0.020
91678950|NCT00546572|183250494|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.042|TWO_SIDED|95.0|-4.9|-0.1|||Limitation of arm movement: any; differe||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-4.9|0.042
91678951|NCT00546572|183250499|SUPERIORITY_OR_OTHER||difference in proportions|-7.9||||0.034|TWO_SIDED|95.0|-15.2|-0.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|New generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.6|-15.2|0.034
91678952|NCT00546572|183250499|SUPERIORITY_OR_OTHER||difference in proportions|-6.9||||0.039|TWO_SIDED|95.0|-13.6|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Aggravated generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-13.6|0.039
91678953|NCT03979820|183250504|OTHER||Ratio of geometric mean TSFs|544.36|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|340.57|870.09|||ANOVA||"The arm Phenelzine/Phenelzine + Tyramine represented the numerator. The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||870.09|340.57|
91678954|NCT03979820|183250504|OTHER||Ratio of geometric mean TSFs|123.22|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|77.09|196.95|||ANOVA||"The arm 10 mg BI 1467335/10 mg BI 1467335 + Tyramine represented the numerator.~The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||196.95|77.09|
91678955|NCT01229735|183250508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||=|0.7007|TWO_SIDED|95.0|0.7|1.7||P-value is from likelihood ratio test of treatment group regression coefficient against 0.|Regression, Logistic|||The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.||1.7|0.7|=0.7007
91678956|NCT01355159|183250555|SUPERIORITY||Risk Ratio (RR)|1.1||||0.37|TWO_SIDED|95.0|0.9|1.34|||Chi-squared|||||1.34|0.90|0.37
91678957|NCT01355159|183250557|SUPERIORITY||Risk Ratio (RR)|1.29||||0.37|TWO_SIDED|95.0|0.74|2.28|||Chi-squared|||||2.28|0.74|0.37
91678958|NCT01355159|183250558|SUPERIORITY||Risk Ratio (RR)|0.64||||0.21|TWO_SIDED|95.0|0.31|1.31|||Chi-squared|||||1.31|0.31|0.21
91678959|NCT01355159|183250559|SUPERIORITY||Risk Ratio (RR)|0.97||||0.71|TWO_SIDED|95.0|0.82|1.15|||Chi-squared|||||1.15|0.82|0.71
91678960|NCT01355159|183250560|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.13|||Chi-squared|||||1.13|0.86|0.87
91678961|NCT01355159|183250561|SUPERIORITY||Risk Ratio (RR)|1.21||||0.75|TWO_SIDED|95.0|0.37|3.96|||Chi-squared|||||3.96|0.37|0.75
91678962|NCT01355159|183250562|SUPERIORITY||Risk Ratio (RR)|1.52||||0.19|TWO_SIDED|95.0|0.81|2.84|||Chi-squared|||||2.84|0.81|0.19
91678963|NCT01355159|183250563|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|7.0||0.61|TWO_SIDED|95.0|-0.96|1.63|||t-test, 2 sided|||||1.63|-0.96|0.61
91678964|NCT01355159|183250564|SUPERIORITY||Risk Ratio (RR)|0.6||||0.14|TWO_SIDED|95.0|0.3|1.19|||Chi-squared|||||1.19|0.30|0.14
91678965|NCT01355159|183250565|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.41|1.39|||Chi-squared|||||1.39|0.41|0.37
91678966|NCT01355159|183250566|SUPERIORITY||Risk Ratio (RR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.3|||Chi-squared|||||1.30|0.81|0.82
91678967|NCT01355159|183250567|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
91678968|NCT01355159|183250568|SUPERIORITY||Risk Ratio (RR)|0.63||||0.07|TWO_SIDED|95.0|0.37|1.05|||Chi-squared|||||1.05|0.37|0.07
91678969|NCT01355159|183250569|SUPERIORITY||Risk Ratio (RR)|1.2||||0.65|TWO_SIDED|95.0|0.54|2.66|||Chi-squared|||||2.66|0.54|0.65
91678970|NCT01355159|183250570|SUPERIORITY||Risk Ratio (RR)|0.34||||0.1|TWO_SIDED|95.0|0.09|1.23|||Chi-squared|||||1.23|0.09|0.10
91678971|NCT01355159|183250571|SUPERIORITY||Risk Ratio (RR)|2.04||||0.33|TWO_SIDED|95.0|0.49|8.57|||Chi-squared|||||8.57|0.49|0.33
91678972|NCT01355159|183250572|SUPERIORITY||Risk Ratio (RR)|0.97||||0.94|TWO_SIDED|95.0|0.47|2.0|||Chi-squared|||||2.00|0.47|0.94
91678973|NCT01355159|183250573|SUPERIORITY||Risk Ratio (RR)|1.61||||0.06|TWO_SIDED|95.0|0.97|2.66|||Chi-squared|||||2.66|0.97|0.06
91678974|NCT01355159|183250574|SUPERIORITY||Risk Ratio (RR)|2.37||||0.21|TWO_SIDED|95.0|0.61|9.14|||Chi-squared|||||9.14|0.61|0.21
91678975|NCT01355159|183250575|SUPERIORITY||Risk Ratio (RR)|1.2||||0.38|TWO_SIDED|95.0|0.8|1.8|||Chi-squared|||||1.80|0.80|0.38
91678976|NCT01355159|183250576|SUPERIORITY||Mean Difference (Net)|-1.6||||46|TWO_SIDED|95.0|-5.84|2.64|||t-test, 2 sided|||||2.64|-5.84|046
91678977|NCT01355159|183250577|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
91678978|NCT01355159|183250578|SUPERIORITY||Risk Ratio (RR)|2.0||||0.42|TWO_SIDED|95.0|0.37|10.92|||Chi-squared|||||10.92|0.37|0.42
91678979|NCT03276221|183250580|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.215
91678980|NCT03276221|183250581|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.495|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of picking the correct box for the abstinence group above and beyond the monitoring group (positive values indicate better memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.495
91678981|NCT03276221|183250582|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.050
91678982|NCT03276221|183250583|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.532|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.532
91692393|NCT02770170|183279670|OTHER||Risk Difference (RD)|-12.5||||0.2906|TWO_SIDED|80.0|-25.99|1.68|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||1.68|-25.99|0.2906
91692394|NCT02770170|183279671|OTHER||Risk Difference (RD)|-9.64||||0.5687|TWO_SIDED|80.0|-25.79|7.45|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.45|-25.79|0.5687
91692395|NCT02770170|183279671|OTHER||Risk Difference (RD)|2.5||||0.9217|TWO_SIDED|80.0|-14.67|19.17|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||19.17|-14.67|0.9217
91717603|NCT01115452|183327921|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.66||||0.8767||95.0|-7.75|9.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.08|-7.75|0.8767
91717604|NCT01115452|183327921|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.6367||95.0|-6.39|10.42||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.42|-6.39|0.6367
91717605|NCT01115452|183327922|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.95||||0.6417|TWO_SIDED|95.0|-10.22|6.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.32|-10.22|0.6417
91717606|NCT01115452|183327922|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.92|TWO_SIDED|95.0|-7.99|8.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.85|-7.99|0.9200
91717607|NCT01115452|183327922|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.38||||0.5766||95.0|-6.02|10.78||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.78|-6.02|0.5766
91717608|NCT01115452|183327923|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.58||||0.393|TWO_SIDED|95.0|-11.65|4.68||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.68|-11.65|0.3930
91487049|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.781|||||TWO_SIDED|95.0|0.42|0.93|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.93|0.42|
91487050|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.962|||||TWO_SIDED|95.0|0.48|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.99|0.48|
91717609|NCT01115452|183327923|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7||||0.6896|TWO_SIDED|95.0|-10.12|6.71||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.71|-10.12|0.6896
91717610|NCT01115452|183327923|SUPERIORITY_OR_OTHER||Adjustes mean difference|1.88||||0.6591|TWO_SIDED|95.0|-6.52|10.28||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.28|-6.52|0.6591
91717611|NCT01115452|183327924|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.08||||0.6301||95.0|-10.6|6.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.45|-10.60|0.6301
91717612|NCT01115452|183327924|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.76||||0.6888|TWO_SIDED|95.0|-10.46|6.93||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.93|-10.46|0.6888
91717613|NCT01115452|183327924|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.32||||0.9428|TWO_SIDED|95.0|-8.37|9.0||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.00|-8.37|0.9428
91717614|NCT01115452|183327925|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.58||||0.5504|TWO_SIDED|95.0|-11.1|5.95||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.95|-11.10|0.5504
91717615|NCT01115452|183327925|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1||||0.634|TWO_SIDED|95.0|-10.8|6.6||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.60|-10.80|0.6340
91717616|NCT01115452|183327925|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.48||||0.9127|TWO_SIDED|95.0|-8.2|9.16|||ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.16|-8.20|0.9127
91717617|NCT01115452|183327926|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.15||||0.6192|TWO_SIDED|95.0|-10.67|6.38||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.38|-10.67|0.6192
91717618|NCT01115452|183327926|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6||||0.8912|TWO_SIDED|95.0|-8.1|9.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.30|-8.10|0.8912
91717619|NCT01115452|183327926|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.75||||0.5321|TWO_SIDED|95.0|-5.93|11.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution|Null hypothesis is no difference between treatments.||11.43|-5.93|0.5321
91487051|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.902|||||TWO_SIDED|95.0|-0.2|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.98|-0.20|
91487052|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.21|||||TWO_SIDED|95.0|-0.07|0.58|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.58|-0.07|
91717620|NCT01115452|183327927|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.37||||0.4055|TWO_SIDED|95.0|-11.37|4.63||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.63|-11.37|0.4055
91717621|NCT01115452|183327927|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.74||||0.8573|TWO_SIDED|95.0|-7.42|8.91||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.91|-7.42|0.8573
91717622|NCT01115452|183327927|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.3193|TWO_SIDED|95.0|-4.03|12.27||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.27|-4.03|0.3193
91717623|NCT01115452|183327928|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.23||||0.4264||95.0|-4.77|11.23||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||11.23|-4.77|0.4264
91717624|NCT01115452|183327928|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.04||||0.8008|TWO_SIDED|95.0|-7.42|9.21||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.21|-7.42|0.8008
91678983|NCT03276221|183250584|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.07||0.226|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.226
91678984|NCT03276221|183250585|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.369|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.369
91678985|NCT03276221|183250586|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.647|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.647
91678986|NCT03276221|183250587|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.511|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.511
91678987|NCT03276221|183250588|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.312|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.312
91678988|NCT03276221|183250589|SUPERIORITY||Slope|1.92|STANDARD_ERROR_OF_MEAN|9.27||0.836|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate higher slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.836
91678989|NCT03276221|183250590|SUPERIORITY||Slope|-0.5|STANDARD_ERROR_OF_MEAN|3.93||0.898|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median incongruency cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for incongruent trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.898
91487053|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.978|||||TWO_SIDED|95.0|0.8|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.99|0.80|
91487054|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.92|||||TWO_SIDED|95.0|0.12|0.98|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.98|0.12|
91717625|NCT01115452|183327928|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.18||||0.5969|TWO_SIDED|95.0|-10.33|5.97||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.97|-10.33|0.5969
91717626|NCT01115452|183327929|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.14||||0.2059|TWO_SIDED|95.0|-13.14|2.86||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.86|-13.14|0.2059
91717627|NCT01115452|183327929|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.9248|TWO_SIDED|95.0|-8.56|7.77||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.77|-8.56|0.9248
91717628|NCT01115452|183327929|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.75||||0.2508|TWO_SIDED|95.0|-3.4|12.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.90|-3.40|0.2508
91717629|NCT01115452|183327930|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.12||||0.7822|TWO_SIDED|95.0|-6.86|9.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.10|-6.86|0.7822
91717630|NCT01115452|183327930|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.44||||0.7208|TWO_SIDED|95.0|-6.52|9.41||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.41|-6.52|0.7208
91717631|NCT01115452|183327931|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.36||||0.7318|TWO_SIDED|95.0|-9.18|6.46||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.46|-9.18|0.7318
91717632|NCT01115452|183327931|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.05||||0.7949|TWO_SIDED|95.0|-6.93|9.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.03|-6.93|0.7949
91717633|NCT01115452|183327931|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.41||||0.5507|TWO_SIDED|95.0|-5.56|10.37||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.37|-5.56|0.5507
91487055|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.855|||||TWO_SIDED|95.0|0.58|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.95|0.58|
91487056|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.886|||||TWO_SIDED|95.0|0.52|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.97|0.52|
91717634|NCT01115452|183327932|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72||||0.8549|TWO_SIDED|95.0|-8.54|7.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period|Null hypothesis is no difference between treatments.||7.10|-8.54|0.8549
91678990|NCT03276221|183250591|SUPERIORITY||Slope|16.54|STANDARD_ERROR_OF_MEAN|9.05||0.068|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the multitasking cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for multitasking trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.068
91678991|NCT03276221|183250592|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.15|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct response for the abstinence group above and beyond the monitoring group (positive values indicate higher accuracy for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.150
91678992|NCT03276221|183250593|SUPERIORITY||Slope|179.11|STANDARD_ERROR_OF_MEAN|281.76||0.525|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.525
91678993|NCT03276221|183250594|SUPERIORITY||Slope|-10.86|STANDARD_ERROR_OF_MEAN|5.24||0.038|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the stop signal task module. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the inhibition latency for the abstinence group above and beyond the monitoring group (positive values indicate slower inhibition for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.038
91678994|NCT03276221|183250595|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.576|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.576
91678995|NCT03276221|183250596|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.296|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of trials with strategic responding for the abstinence group above and beyond the monitoring group (positive values indicate higher rates of strategic responding for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.296
91678996|NCT03276221|183250597|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.65|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the discriminability measure for the abstinence group above and beyond the monitoring group (positive values indicate higher discriminability rates for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.650
91692142|NCT00406367|183279070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||No type I-error adjustment was necessary in this study.|ANCOVA|Indepent variables in the model were treatment, baseline JRS-Severity score, gender, age, dose, and pooled center.||The null hypothesis in the analysis of covariance (ANCOVA) model was the absence of difference in the change from baseline in the JRS severity subscore between incobotulinumtoxinA (Xeomin) and placebo. The ANCOVA model was performed 2-sided (type-I error=5 percent) and change from baseline in the JRS Severity subscore assessed by a blinded Independent Rater as dependent variable. The independent variables were treatment, baseline JRS Severity subscore, gender, age, dose group, and pooled center.||-0.5|-1.4|<0.001
91487057|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.98|||||TWO_SIDED|95.0|0.94|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.99|0.94|
91487058|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.801|||||TWO_SIDED|95.0|0.42|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.94|0.42|
91487059|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.878|||||TWO_SIDED|95.0|0.53|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.96|0.53|
91678997|NCT03276221|183250598|SUPERIORITY||Slope|-11.64|STANDARD_ERROR_OF_MEAN|9.55||0.223|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.223
91678998|NCT02615171|183250605|OTHER|||||||0.0106|||||||t-test, 2 sided|||||||0.0106
91678999|NCT02615171|183250606|OTHER|||||||0.0027|||||||Chi-squared|||||||0.0027
91679000|NCT02615171|183250607|OTHER|||||||0.7829|||||||Wilcoxon rank sum test|||||||0.7829
91679001|NCT00975286|183250611|SUPERIORITY_OR_OTHER||[Least squares (LS) mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.463|-0.171||Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (\<8.0,\>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.171|-0.463|<0.0001
91679002|NCT01781481|183250667|SUPERIORITY_OR_OTHER||Inter-rater reliability|0.87|||||TWO_SIDED||||||||Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.|||||
91679003|NCT01781481|183250667|SUPERIORITY_OR_OTHER||Cronbach's Alpha|0.91|||||TWO_SIDED||||||||Overall internal consistency of the overall Pediatric INTERMED scale (34 items).|||||
91679004|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.05||||||Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p\< .05.|Pearson Correlation Coefficients|||||||<0.05
91679005|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Social domain scores on the Pediatric INTERMED.||||<0.01
91679006|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
91679007|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Biological and Health Service Pediatric INTERMED domain scores.||||<0.01
91487060|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.983|||||TWO_SIDED|95.0|0.94|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.99|0.94|
91679008|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Psychology and Social Pediatric INTERMED domain scores.||||<0.01
91679009|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||||||<0.01
91679010|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.||||<0.01
91679011|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
91487061|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.891|||||TWO_SIDED|95.0|0.73|0.96|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.96|0.73|
91679012|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Health Service Pediatric INTERMED domain scores.||||<0.01
91679013|NCT01781481|183250668|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.||||<0.01
91679014|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis||||>0.05
91692143|NCT02632409|183279127|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0008|TWO_SIDED|98.22|0.55|0.9|||Stratified Cox Proportional hazard model|||||0.90|0.55|0.0008
91487062|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.923|||||TWO_SIDED|95.0|0.77|0.98|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.98|0.77|
91679015|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).||||<0.01
91679016|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).||||<0.01
91679017|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).||||<0.01
91679018|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.||||<0.01
91679019|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.||||>0.05
91679020|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.||||>0.05
91679021|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.||||>0.05
91679022|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.||||>0.05
91679023|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.||||>0.05
91679024|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).||||>0.05
91679025|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)||||>0.05
91679026|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)||||<0.01
91679027|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.||||>0.05
91679028|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.||||>0.05
91679029|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.||||>0.05
91679030|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\< 0.05.|Spearman Correlation Coefficent|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)||||<0.05
91679031|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.||||>0.05
91679032|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis."||||>0.05
91679033|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.01
91679034|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating)."||||<0.01
91679035|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||<0.01
91679036|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scale"||||<0.01
91679037|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeries"||||>0.05
91679038|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone."||||>0.05
91679039|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators."||||>0.05
91679040|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications."||||>0.05
91487063|NCT04823650|182846749|OTHER||Intraclass correlation coefficient|0.987|||||TWO_SIDED|95.0|0.97|1.0|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||1.00|0.97|
91717635|NCT01115452|183327932|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.15||||0.9705|TWO_SIDED|95.0|-8.13|7.83||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.83|-8.13|0.9705
91487064|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.976|||||TWO_SIDED|95.0|0.74|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.99|0.74|
91487065|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.972|||||TWO_SIDED|95.0|0.92|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.99|0.92|
91487066|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.899|||||TWO_SIDED|95.0|0.66|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||0.97|0.66|
91679041|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05. The P-Value indicated above was found for all the correlations which were examined.|Spearman Correlation Coefficient|||"Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications."||||>0.05
91679042|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis."||||>0.05
91679043|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.05
91679044|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)"||||<0.05
91679045|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating)."||||>0.05
91679046|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale"||||<0.01
91679047|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries."||||>0.05
91717636|NCT01115452|183327932|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.57||||0.8867|TWO_SIDED|95.0|-7.39|8.54||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.54|-7.39|0.8867
91487067|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.975|||||TWO_SIDED|95.0|0.92|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|0.92|
91487068|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.974|||||TWO_SIDED|95.0|0.8|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|0.80|
91487069|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.952|||||TWO_SIDED|95.0|-0.19|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|-0.19|
91487070|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.969|||||TWO_SIDED|95.0|0.89|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.99|0.89|
91679048|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone."||||>0.05
91679049|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. ."||||>0.05
91679050|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medications"||||>0.05
91487071|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.968|||||TWO_SIDED|95.0|0.91|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.99|0.91|
91487072|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.893|||||TWO_SIDED|95.0|0.5|0.97|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.97|0.50|
91487073|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|-0.15|||||TWO_SIDED|95.0|-0.64|0.42|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.42|-0.64|
91487074|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.891|||||TWO_SIDED|95.0|0.64|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.97|0.64|
91679051|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis."||||>0.05
91679052|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview)."||||>0.05
91679053|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating)."||||>0.05
91679054|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||>0.05
91679055|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Being"||||>0.05
91679056|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries."||||>0.05
91487075|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.561|||||TWO_SIDED|95.0|0.0|0.85|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.85|0.00|
91487076|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.81|||||TWO_SIDED|95.0|0.49|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.94|0.49|
91679057|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis."||||<0.05
91679058|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significiance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.01
91679059|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The Threshold for significance is p\<0.05)|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab)."||||<0.01
91679060|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis."||||>0.05
91679061|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation."||||<0.05
91679062|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating)."||||<0.01
91679063|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating)."||||<0.01
91679064|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale."||||<0.05
91679065|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries."||||>0.05
91679066|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone."||||>0.05
91679067|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.05
91679068|NCT01781481|183250682|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications."||||>0.05
91487077|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.967|||||TWO_SIDED|95.0|0.68|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.99|0.68|
91487078|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.885|||||TWO_SIDED|95.0|-0.11|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.98|-0.11|
91717637|NCT00288912|183327933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.007|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.2|-1.0|0.007
91487079|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.134|||||TWO_SIDED|95.0|-0.17|0.53|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.53|-0.17|
91679069|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
91679070|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
91679071|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score||||<0.01
91679072|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
91679073|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
91679074|NCT01781481|183250683|SUPERIORITY_OR_OTHER|||||||0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).||||0.01
91679075|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.05
91679076|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
91679077|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale||||<0.01
91679078|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.05
91679079|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
91679080|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
91679081|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
91679082|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
91679083|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score||||<0.01
91679084|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
91679085|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale||||<0.01
91679086|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
91679087|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
91679088|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
91679089|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale||||<0.01
91679090|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
91679091|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).||||<0.01
91679092|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
91679093|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
91679094|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
91679095|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score||||<0.01
91679096|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.||||>0.05
91679097|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
91679098|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
91679099|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
91679100|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
91679101|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale||||<0.01
91679102|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
91679103|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
91679104|NCT01781481|183250683|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
91679105|NCT01781481|183250684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.33|||||TWO_SIDED|95.0|2.02|34.47||||||||34.47|2.02|
91679106|NCT01781481|183250685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.52|||||TWO_SIDED|95.0|1.7|43.02||||||||43.02|1.70|
91679107|NCT01781481|183250686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.27|||||TWO_SIDED|95.0|2.17|24.36||||||||24.36|2.17|
91679108|NCT01781481|183250687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.79|||||TWO_SIDED|95.0|5.0|122.84||||||||122.84|5.00|
91679109|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.||||<0.01
91679110|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.||||<0.01
91679111|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.||||<0.01
91679112|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being||||<0.01
91679113|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
91487080|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.896|||||TWO_SIDED|95.0|0.65|0.97|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.97|0.65|
91487081|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.598|||||TWO_SIDED|95.0|0.04|0.87|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.87|0.04|
91487082|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.849|||||TWO_SIDED|95.0|-0.09|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.97|-0.09|
91679114|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||<0.01
91679115|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis."||||<0.01
91679116|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being."||||<0.01
91679117|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
91679118|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
91679119|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis."||||>0.05
91679120|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being."||||>0.05
91679121|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
91679122|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis."||||>0.05
91679123|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
91679124|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being."||||<0.01
91679125|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
91679126|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
91679127|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis."||||>0.05
91679128|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being."||||>0.05
91679129|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
91679130|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care."||||<0.01
91679131|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
91679132|NCT01781481|183250688|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being."||||<0.01
91692144|NCT02632409|183279128|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0005|TWO_SIDED|98.72|0.35|0.84|||Stratified Cox Proportional hazard model|||||0.84|0.35|0.0005
91692396|NCT02770170|183279671|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-14.03|14.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||14.03|-14.03|
91692397|NCT00162981|183279675|SUPERIORITY_OR_OTHER||||||<|0.0182||95.0|||||1-sided Wilcoxon signed rank test|1-sided Wilcoxon signed rank test was used to assess the difference from baseline.||||||<0.0182
91487083|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.907|||||TWO_SIDED|95.0|0.34|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.98|0.34|
91487084|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.98|||||TWO_SIDED|95.0|0.92|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.99|0.92|
91487085|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.922|||||TWO_SIDED|95.0|0.63|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.98|0.63|
91487086|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.939|||||TWO_SIDED|95.0|0.76|0.98|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.98|0.76|
91679133|NCT01781481|183250689|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.08|||<|0.01|TWO_SIDED|||||p\<0.05 Threshold for statistical significance|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
91487087|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.988|||||TWO_SIDED|95.0|0.96|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||1.00|0.96|
91487088|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.911|||||TWO_SIDED|95.0|0.61|0.98|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.98|0.61|
91487089|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.942|||||TWO_SIDED|95.0|0.79|0.98|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.98|0.79|
91487090|NCT04823650|182846750|OTHER||Intraclass correlation coefficient|0.987|||||TWO_SIDED|95.0|0.96|1.0|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||1.00|0.96|
91487091|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.985|||||TWO_SIDED|95.0|0.95|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||1.00|0.95|
91487092|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.995|||||TWO_SIDED|95.0|0.09|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||1.00|0.09|
91692398|NCT00162981|183279675|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|1-sided Wilcoxon signed rank test|||||||0.0001
91692399|NCT00162981|183279678|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.|||||<|0.0001||95.0|||||1-sided Wilcoxon Rank-Sum Test|1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.||||||<0.0001
91692400|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% confidence intervals (CIs) for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.5|7.4||||||15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The mixed model for repeated measurements (MMRM) included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.4|0.5|
91692401|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-0.5|6.5||||||30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||6.5|-0.5|
91692402|NCT03187301|183279684|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.2|7.2||||||45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.2|0.2|
91679134|NCT01781481|183250690|SUPERIORITY_OR_OTHER||R2Change|0.05|||<|0.01|TWO_SIDED|||||Threshold for statistical significance is p\<0.01|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
91679135|NCT01781481|183250691|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.05|||<|0.01|TWO_SIDED|||||p\<.05 threshold for statistical significance|Regression, Linear|Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).||||<0.01
91679136|NCT01781481|183250692|SUPERIORITY_OR_OTHER||R2Change|0.03|||<|0.05|TWO_SIDED|||||Threshold for statistical significance is p \<0.05.|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.05
91526780|NCT01598298|182929044|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.57|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.||-0.55|-1.57|<0.0001
91679137|NCT01781481|183250693|SUPERIORITY_OR_OTHER||R2Change|0.07|||<|0.01|TWO_SIDED||||||Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
91679138|NCT00372411|183250694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.08|TWO_SIDED|95.0|-0.23|4.58||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||4.58|-0.23|0.08
91679139|NCT00372411|183250694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.02|TWO_SIDED|95.0|0.57|5.18||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||5.18|0.57|0.02
91679140|NCT00372411|183250694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.92|TWO_SIDED|95.0|-2.94|2.65||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||2.65|-2.94|0.92
91679141|NCT00372411|183250694|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.58||||0.63|TWO_SIDED|95.0|-2.97|1.81||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||1.81|-2.97|0.63
91679142|NCT00372411|183250695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64||||0.009|TWO_SIDED|95.0|2.03|13.24||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||13.24|2.03|0.009
91679143|NCT00372411|183250695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.95||||0.04|TWO_SIDED|95.0|0.34|11.56||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||11.56|0.34|0.04
91717638|NCT00288912|183327933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.105|TWO_SIDED|95.0|-0.8|0.1|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.1|-0.8|0.105
91717639|NCT00288912|183327934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.093|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.0|-0.5|0.093
91717640|NCT00288912|183327934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.43|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.2|-0.2|0.43
91717641|NCT00288912|183327935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.78
91717642|NCT00288912|183327935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.79
91717643|NCT00288912|183327936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.043|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.8|0.0|0.043
91717644|NCT00288912|183327936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.066|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.7|0.0|0.066
91717645|NCT03312738|183327937|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|90.0|0.4|0.71||||||||0.71|0.40|
91679144|NCT00372411|183250695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.81|TWO_SIDED|95.0|-3.87|4.94||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.94|-3.87|0.81
91717646|NCT03312738|183327938|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.32|0.67||||||||0.67|0.32|
91717647|NCT03312738|183327939|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|90.0|0.69|1.89||||||||1.89|0.69|
91717648|NCT00607893|183327970|OTHER||Mean Difference (Final Values)|0.071||||0.38|TWO_SIDED|95.0|-0.09|0.23|||Regression, Linear||F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.23|-0.090|0.38
91717649|NCT00607893|183327971|OTHER||Mean Difference (Final Values)|1.83||||0.85|TWO_SIDED|95.0|-17.42|21.07|||Regression, Linear|||||21.07|-17.42|0.85
91717650|NCT00607893|183327972|OTHER||Mean Difference (Final Values)|0.14||||0.92|TWO_SIDED|95.0|-2.6|2.87|||Regression, Linear|||||2.87|-2.60|0.92
91717651|NCT00607893|183327973|OTHER||Mean Difference (Final Values)|0.21||||0.55|TWO_SIDED|95.0|-0.48|0.91|||Regression, Linear|||||0.91|-0.48|0.55
91717652|NCT00607893|183327974|OTHER||Mean Difference (Final Values)|0.38||||0.17|TWO_SIDED|95.0|-0.16|0.92|||Regression, Linear|||||0.92|-0.16|0.17
91717653|NCT00607893|183327975|OTHER||Mean Difference (Final Values)|2.4||||0.076|TWO_SIDED|95.0|-0.26|5.07|||Regression, Linear|||||5.07|-0.26|0.076
91717654|NCT00607893|183327976|OTHER||Mean Difference (Final Values)|0.062||||0.019|TWO_SIDED|95.0|0.01|0.11|||Regression, Linear||sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.11|0.010|0.019
91717655|NCT00607893|183327977|OTHER||Mean Difference (Final Values)|0.17||||0.68|TWO_SIDED|95.0|-0.64|0.99|||Regression, Linear|||||0.99|-0.64|0.68
91717656|NCT00607893|183327978|OTHER||Mean Difference (Final Values)|1.35||||0.59|TWO_SIDED|95.0|-3.6|6.31|||Regression, Linear|||||6.31|-3.60|0.59
91717657|NCT00607893|183327979|OTHER||Mean Difference (Final Values)|6.93|||<|0.001|TWO_SIDED|95.0|3.04|10.81|||Regression, Linear|||||10.81|3.04|<0.001
91717658|NCT03073486|183328041|OTHER|||||||0.2301|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.2301
91717659|NCT03073486|183328042|OTHER|||||||0.6888|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.6888
91717660|NCT03073486|183328043|OTHER|||||||0.1361|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.1361
91717661|NCT01079780|183328051|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|||||||||||||
91717662|NCT01079780|183328052|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
91717663|NCT01079780|183328054|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.55|TWO_SIDED||||||Log Rank|||||||0.55
91487093|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.989|||||TWO_SIDED|95.0|0.96|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite||1.00|0.96|
91679145|NCT00372411|183250695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19||||0.55|TWO_SIDED|95.0|-2.74|5.12||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||5.12|-2.74|0.55
91679146|NCT00372411|183250696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41||||0.22|TWO_SIDED|95.0|-11.52|2.7||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||2.70|-11.52|0.22
91679147|NCT00372411|183250696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1||||0.005|TWO_SIDED|95.0|-13.61|-2.6||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||-2.60|-13.61|0.005
91679148|NCT00372411|183250696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.93||||0.82|TWO_SIDED|95.0|-7.03|8.89||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||8.89|-7.03|0.82
91679149|NCT00372411|183250696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.13||||0.55|TWO_SIDED|95.0|-9.2|4.93||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.93|-9.20|0.55
91679150|NCT00372411|183250697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.08|TWO_SIDED|95.0|-1.73|0.11||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.11|-1.73|0.08
91679151|NCT00372411|183250697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.03|TWO_SIDED|95.0|-1.62|-0.06||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||-0.06|-1.62|0.03
91679152|NCT00372411|183250698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.25|0.26||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.26|-0.25|0.95
91679153|NCT00372411|183250698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.1|TWO_SIDED|95.0|-0.42|0.04||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||0.04|-0.42|0.10
91679154|NCT00667810|183250707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||0.057|TWO_SIDED|95.0|-3.71|0.05||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||0.05|-3.71|0.057
91487094|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.983|||||TWO_SIDED|95.0|0.95|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||0.99|0.95|
91679155|NCT00667810|183250707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.848|TWO_SIDED|95.0|-1.73|2.1||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||2.10|-1.73|0.848
91487095|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.989|||||TWO_SIDED|95.0|0.9|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||1.00|0.90|
91487096|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.982|||||TWO_SIDED|95.0|0.28|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs APDM||1.00|0.28|
91679156|NCT00667810|183250708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.459|TWO_SIDED|95.0|-2.48|5.49||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.49|-2.48|0.459
91679157|NCT00667810|183250708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.623|TWO_SIDED|95.0|-3.04|5.07||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.07|-3.04|0.623
91679158|NCT00667810|183250709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.654|TWO_SIDED|95.0|-0.15|0.09|||Mixed Models Analysis|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||0.09|-0.15|0.654
91679159|NCT00667810|183250710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.18||||0.085|TWO_SIDED|95.0|-15.38|1.02|||ANCOVA|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||1.02|-15.38|0.085
91679160|NCT00667810|183250711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.437|TWO_SIDED|95.0|-1.55|3.57|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.57|-1.55|0.437
91679161|NCT00667810|183250711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.423|TWO_SIDED|95.0|-1.54|3.66|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.66|-1.54|0.423
91679162|NCT00667810|183250712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.212|TWO_SIDED|95.0|-3.4|0.76|||Mixed Models Analysis|||||0.76|-3.40|0.212
91679163|NCT00667810|183250712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.725|TWO_SIDED|95.0|-1.76|2.52|||Mixed Models Analysis|||||2.52|-1.76|0.725
91679164|NCT00667810|183250713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.149|TWO_SIDED|95.0|-1.15|7.56|||Mixed Models Analysis|||||7.56|-1.15|0.149
91679165|NCT00667810|183250713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01||||0.375|TWO_SIDED|95.0|-2.44|6.46|||Mixed Models Analysis|||||6.46|-2.44|0.375
91679166|NCT00667810|183250714|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not specifed.|Log Rank|||||||0.030
91679167|NCT00667810|183250714|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Log Rank|||||||0.567
91679168|NCT00667810|183250715|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Log Rank|||||||0.079
91679169|NCT00667810|183250715|SUPERIORITY_OR_OTHER|||||||0.675|TWO_SIDED||||||Log Rank|||||||0.675
91679170|NCT00667810|183250716|SUPERIORITY_OR_OTHER|||||||0.846|TWO_SIDED||||||Log Rank|||Not spsecified.||||0.846
91679171|NCT00667810|183250716|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Log Rank|||||||0.797
91679172|NCT00667810|183250717|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Log Rank|||||||0.933
91679173|NCT00667810|183250717|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Log Rank|||||||0.714
91679174|NCT00667810|183250719|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.277
91679175|NCT00667810|183250719|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.996
91679176|NCT00667810|183250721|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.855
91679177|NCT00667810|183250721|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.423
91679178|NCT00667810|183250722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.516|TWO_SIDED|95.0|-0.65|0.33|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.33|-0.65|0.516
91679179|NCT00667810|183250722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.21|-0.79|0.257
91679180|NCT00667810|183250723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.238|TWO_SIDED|95.0|-0.96|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.24|-0.96|0.238
91679181|NCT00667810|183250723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.564|TWO_SIDED|95.0|-0.78|0.43|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.43|-0.78|0.564
91679182|NCT02227147|183250748|SUPERIORITY||Difference in percentage|40.4|||=|0.006|TWO_SIDED|90.0|14.2|66.6|||Chi-squared|||||66.6|14.2|=0.006
91679183|NCT02227147|183250749|SUPERIORITY||Difference in percentage|36.1|||=|0.013|TWO_SIDED|95.0|9.4|62.7|||Chi-squared|||||62.7|9.4|=0.013
91679184|NCT02227147|183250750|SUPERIORITY||difference in percentage|19.0|||=|0.191|TWO_SIDED|95.0|-9.0|47.1|||Chi-squared|||week 4 - central reviewer||47.1|-9.0|=0.191
91679185|NCT02227147|183250750|SUPERIORITY||difference in percentage|10.7|||=|0.464|TWO_SIDED|95.0|-17.7|39.1|||Chi-squared|||week 6 - central reviewer||39.1|-17.7|=0.464
91679186|NCT02227147|183250750|SUPERIORITY||difference in percentage|14.9|||=|0.308|TWO_SIDED|95.0|-13.4|43.1|||Chi-squared|||week 4 - investigator||43.1|-13.4|=0.308
91679187|NCT02227147|183250750|SUPERIORITY||difference in percentage|23.6|||=|0.106|TWO_SIDED|95.0|-4.2|51.3|||Chi-squared|||week 6 - investigator||51.3|-4.2|=0.106
91679188|NCT02227147|183250751|SUPERIORITY||difference in percentage|9.5|||=|0.255|TWO_SIDED|95.0|-6.9|25.9|||Chi-squared|||week 4||25.9|-6.9|=0.255
91679189|NCT02227147|183250751|SUPERIORITY||difference in percentage|0.8|||=|0.927|TWO_SIDED|95.0|-15.6|17.1|||Chi-squared|||week 6||17.1|-15.6|=0.927
91679190|NCT02227147|183250751|SUPERIORITY||difference in percentage|18.6|||=|0.062|TWO_SIDED|95.0|-0.7|37.8|||Chi-squared|||week 8||37.8|-0.7|=0.062
91487097|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.984|||||TWO_SIDED|95.0|0.96|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||0.99|0.96|
91487098|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.992|||||TWO_SIDED|95.0|0.97|1.0|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||1.00|0.97|
91679191|NCT02227147|183250752|SUPERIORITY||difference in least square means|1.1|||=|0.745|TWO_SIDED|95.0|-5.6|7.7|||ANCOVA|||||7.7|-5.6|=0.745
91679192|NCT02227147|183250753|SUPERIORITY||difference in percentage|-3.8|||=|0.672|TWO_SIDED|95.0|-21.3|13.7|||Chi-squared|||week 4||13.7|-21.3|=0.672
91679193|NCT02227147|183250753|SUPERIORITY||difference in percentage|0.5|||=|0.955|TWO_SIDED|95.0|-18.5|19.6|||Chi-squared|||week 6||19.6|-18.5|=0.955
91679194|NCT02227147|183250753|SUPERIORITY||difference in percentage|-3.6|||=|0.727|TWO_SIDED|95.0|-23.9|16.7|||Chi-squared|||week 8||16.7|-23.9|=0.727
91679195|NCT02227147|183250754|SUPERIORITY||least square mean difference|0.6|||=|0.207|TWO_SIDED|95.0|-0.4|1.5|||ANCOVA|||||1.5|-0.4|=0.207
91679196|NCT02227147|183250755|SUPERIORITY||difference in percentage|-13.3|||=|0.11|TWO_SIDED|95.0|-30.5|3.9|||Chi-squared|||||3.9|-30.5|=0.110
91679197|NCT03514641|183250757|SUPERIORITY||LS Means difference|-2.72||||0.0025|TWO_SIDED|95.0|-4.47|-0.96|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.96|-4.47|0.0025
91679198|NCT03514641|183250758|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.0117|TWO_SIDED|95.0|-4.32|-0.54|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.54|-4.32|0.0117
91679199|NCT03514641|183250759|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1317|TWO_SIDED|95.0|0.92|1.83||Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP|Covariance|||||1.83|0.92|0.1317
91679200|NCT03514641|183250760|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0113|TWO_SIDED|95.0|1.11|2.3|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.30|1.11|0.0113
91679201|NCT03514641|183250761|SUPERIORITY||Mean Difference (Final Values)|-4.63|||<|0.0001|TWO_SIDED|95.0|-6.83|-2.42|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-2.42|-6.83|<0.0001
91679202|NCT03514641|183250762|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0004|TWO_SIDED|95.0|1.32|2.62|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.62|1.32|0.0004
91679203|NCT03514641|183250763|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.0863|TWO_SIDED|95.0|-1.79|0.12|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.12|-1.79|0.0863
91679204|NCT03514641|183250764|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0232|TWO_SIDED|95.0|1.06|2.08|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.08|1.06|0.0232
91679205|NCT03514641|183250765|SUPERIORITY||Odds Ratio (OR)|1.81||||0.014|TWO_SIDED|95.0|1.13|2.91|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.91|1.13|0.0140
91679206|NCT03514641|183250766|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.0011|TWO_SIDED|95.0|-3.7|-0.92|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.92|-3.70|0.0011
91679207|NCT03514641|183250767|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0094|TWO_SIDED|95.0|1.13|2.35|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.35|1.13|0.0094
91679208|NCT03514641|183250768|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.0083|TWO_SIDED|95.0|-5.57|-0.83|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.83|-5.57|0.0083
91679209|NCT03514641|183250769|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.1085|TWO_SIDED|95.0|-1.87|0.19|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.19|-1.87|0.1085
91679210|NCT03514641|183250770|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0837|TWO_SIDED|95.0|-2.67|0.17|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.17|-2.67|0.0837
91679211|NCT03688282|183250778|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91679212|NCT04796779|183250805|SUPERIORITY||||||<|0.001|||||||Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
91679213|NCT04796779|183250806|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||<0.001
91679214|NCT04796779|183250807|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
91679215|NCT04796779|183250808|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
91679216|NCT04796779|183250809|SUPERIORITY|||||||0.57||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||0.57
91679217|NCT01055132|183250857|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.|Least-square mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.0072|||TWO_SIDED|95.0|-0.041|-0.0013|||linear mixed model|Sequence of wear, period and lens were included as fixed effects; site, patient, eye\*patient, period\*patient and period\*eye\*patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.0013|-0.041|
91679218|NCT01055132|183250858|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0062|||TWO_SIDED|95.0|-0.027|-0.003|||linear mixed model|Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period\*patient were included as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.003|-0.027|
91679219|NCT01055132|183250859|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|11.9|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|95.0|4.05|19.79|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.||19.79|4.05|
91679220|NCT01055132|183250860|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|least-square mean difference|7.7|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|0.58|14.8|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.||14.80|0.58|
91679221|NCT00158600|183250862|SUPERIORITY_OR_OTHER||Difference|28.12||||0.0347||95.0|2.07|54.17||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in distance walked from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||54.17|2.07|0.0347
91679222|NCT00158600|183250863|SUPERIORITY_OR_OTHER||Difference|3.4||||0.0055||95.0|1.03|5.77||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in % predicted FVC from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||5.77|1.03|0.0055
91487099|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.987|||||TWO_SIDED|95.0|0.94|1.0|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Natural Speed: ActiGraph vs GAITRite vs APDM||1.00|0.94|
91487100|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|-0.092|||||TWO_SIDED|95.0|-0.44|0.39|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.39|-0.44|
91679223|NCT00158600|183250864|SUPERIORITY_OR_OTHER||Difference|3.18||||0.1093||95.0|-0.73|7.08||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in QMT from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||7.08|-0.73|0.1093
91679224|NCT00158600|183250865|SUPERIORITY_OR_OTHER||Difference|-0.37||||0.8333||95.0|-3.83|3.09||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in PCS from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||3.09|-3.83|0.8333
91679225|NCT00910091|183250938|SUPERIORITY_OR_OTHER|||||||0.1895|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.1895
91679226|NCT00910091|183250939|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0203
91679227|NCT00910091|183250941|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.6980
91717664|NCT01178294|183328055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||one-sided binomial exact test|||Summary statistics for the percentage of participants with serious bleeding episodes responsive at 24 hours after the initiation of treatment are presented, along with the 95% confidence interval (two-sided 95% Clopper-Pearson confidence interval).||||<0.001
91487101|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.971|||||TWO_SIDED|95.0|0.53|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||0.99|0.53|
91487102|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.972|||||TWO_SIDED|95.0|-0.06|1.0|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite||1.00|-0.06|
91487103|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.725|||||TWO_SIDED|95.0|0.3|0.91|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.91|0.30|
91679228|NCT00910091|183250942|SUPERIORITY_OR_OTHER|||||||0.3078|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.3078
91679229|NCT00910091|183250943|SUPERIORITY_OR_OTHER|||||||0.0484|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0484
91679230|NCT01659866|183250944|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91679231|NCT02618408|183250952|SUPERIORITY||Median Difference (Net)|-7.08||||0.0916|TWO_SIDED|95.0|-15.38|1.22|||Wilcoxon (Mann-Whitney)|||||1.22|-15.38|0.0916
91679232|NCT02618408|183250952|SUPERIORITY||Median Difference (Net)|-1.76||||0.7136|TWO_SIDED|95.0|-11.78|8.27|||Wilcoxon (Mann-Whitney)|||Based on the results of a prespecified interim analysis, the enrollment of the low dose SPN-810 arm was halted, and this treatment arm was dropped. Accordingly, all analysis of primary and secondary endpoints focused on the comparison of SPN-810 high dose and placebo||8.27|-11.78|0.7136
91487104|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.946|||||TWO_SIDED|95.0|0.44|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.99|0.44|
91679233|NCT02618408|183250953|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0238|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||||-0.03|-0.46|0.0238
91679234|NCT02618408|183250953|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0683|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.02|-0.47|0.0683
91679235|NCT02618408|183250953|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.136||0.0742|TWO_SIDED|95.0|-0.51|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.02|-0.51|0.0742
91679236|NCT02618408|183250954|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.105||0.3713|TWO_SIDED|95.0|-0.3|0.11|||Mixed Models Analysis|||||0.11|-0.30|0.3713
91679237|NCT02618408|183250954|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.1367|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.06|-0.45|0.1367
91679238|NCT02618408|183250954|SUPERIORITY||Median Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.146||0.1729|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.09|-0.49|0.1729
91679239|NCT02618408|183250955|SUPERIORITY||Mean Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|1.456||0.1407|TWO_SIDED|95.0|-0.72|5.02|||ANCOVA|||This analysis pertains to the physical functioning summary score at Visit 6.||5.02|-0.72|0.1407
91679240|NCT02618408|183250955|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.898||0.5586|TWO_SIDED|95.0|-2.29|1.24|||ANCOVA|||This analysis pertains to the psychosocial health summary score at Visit 6||1.24|-2.29|0.5586
91717665|NCT01663623|183328094|OTHER||Hazard Ratio (HR)|1.07||||0.884|TWO_SIDED|95.0|0.44|2.59||Cox proportional Hazards (Wald Chi Square)|Cox Proportional Hazards model|Analysis was adjusted for ANCA type, disease stage at induction and induction regimen|Analysis performed using a Cox Proportional Hazards model with covariates treatment group, Actual ANCA type, Actual disease stage at induction and Actual induction regimen.|||2.59|0.44|0.884
91679241|NCT02618408|183250956|SUPERIORITY||Median Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|2.07||0.7637|TWO_SIDED|95.0|-4.7|3.45|||ANCOVA|||This analysis pertains to the Total Stress summary score Visit 6.||3.45|-4.70|0.7637
91679242|NCT02618408|183250956|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.895||0.8365|TWO_SIDED|95.0|-1.95|1.58|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.58|-1.95|0.8365
91679243|NCT02618408|183250956|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.829||0.4606|TWO_SIDED|95.0|-2.24|1.02|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.02|-2.24|0.4606
91679244|NCT02618408|183250956|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.837||0.8222|TWO_SIDED|95.0|-1.84|1.46|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||1.46|-1.84|0.8222
91679245|NCT02618408|183250957|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.1031|TWO_SIDED|95.0|-0.43|0.04|||Mixed Models Analysis|||||0.04|-0.43|0.1031
91487105|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.939|||||TWO_SIDED|95.0|-0.12|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs APDM||0.99|-0.12|
91527569|NCT01976364|182930468|OTHER||LS Mean Difference|0.0486|||||TWO_SIDED|95.0|-0.0192|0.1163||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1163|-0.0192|
91679246|NCT02618408|183250957|SUPERIORITY|This analysis pertains to Visit 5|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.132||0.025|TWO_SIDED|95.0|-0.56|-0.04|||Mixed Models Analysis|||||-0.04|-0.56|0.0250
91679247|NCT02618408|183250957|SUPERIORITY|This analysis pertains to Visit 6|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.158||0.0384|TWO_SIDED|95.0|-0.64|-0.02|||Mixed Models Analysis|||||-0.02|-0.64|0.0384
91679248|NCT02618408|183250958|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1935|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||This analysis pertains to the inattention subscale at Visit 6.||0.06|-0.27|0.1935
91679249|NCT02618408|183250958|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.092||0.1445|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|||This analysis pertains to hyperactivity/Impulsivity subscale at Visit 6||0.05|-0.32|0.1445
91679250|NCT02618408|183250958|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1064|TWO_SIDED|95.0|-0.36|0.03|||ANCOVA|||This analysis pertains to the oppositional defiant disorder subscale at Visit 6||0.03|-0.36|0.1064
91679251|NCT02618408|183250958|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.082||0.1418|TWO_SIDED|95.0|-0.28|0.04|||ANCOVA|||This analysis pertains to the combined scale score at Visit 6||0.04|-0.28|0.1418
91679252|NCT04870138|183250959|OTHER|||||||1||||||One-sided Fisher's Exact Test with alpha = 0.05|Fisher Exact|||||||1.000
91487106|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.152|||||TWO_SIDED|95.0|-0.11|0.52|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.52|-0.11|
91679253|NCT04870138|183250961|OTHER||||||<|0.0001|||||||t-test, 1 sided|One-sided single sample t-test with alpha=0.05||Null hypothesis: The proportion of the strain in the inoculum = 0.5||||<0.0001
91679254|NCT03914950|183251009|OTHER|"The calculation of power and sample size is based on a formula that selects the sample size so that the lower limit of the 95% confidence interval by the expected specificity of the new method most probably exceeds the specificity value of the current method.~Receiver operating characteristics (ROC) analysis of the values of SUVmax of the early and delayed images with and without TOF of all pancreatic lesions was done in correlation with the histopathological findings."||||||0.78|||||||DeLong-test|The threshold for statistical significance was p=0.05.||It was calculated that 118 participants would have at least 90% power to demonstrate an improvement in specificity of 25% (to 70%) with the new method assuming a specificity of the current method of 45% at a prevalence of malignant lesions of 70% (corresponding to 30% benign lesions). Assumptions included a discontinuation rate of 25%.||||0.78
91679255|NCT03914950|183251009|OTHER|||||||0.95|||||||DeLong-test|The threshold for statistical significance was p=0.05.||||||0.95
91679256|NCT03167723|183251013|NON_INFERIORITY|15% Non-Inferiority||||||0.036|||||||Farrington-Manning|||||||0.036
91679257|NCT04040322|183251023|SUPERIORITY||Least squares mean difference in change|-1.26||||0.421|TWO_SIDED|95.0|-4.34|1.82||Threshold for statistical significance was p \< 0.05|ANCOVA|||||1.82|-4.34|0.4210
91679258|NCT04536935|183251049|SUPERIORITY|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the PHQ-9 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.8|-1.1|||Mixed Models Analysis|||||-1.1|-1.8|<.001
91679259|NCT04536935|183251050|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the GAD-7 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.6|-1.0|||Mixed Models Analysis|||||-1.0|-1.6|<.001
91679260|NCT04536935|183251051|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the DERS and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.||||||0.73|||||||Mixed Models Analysis|||||||.73
91679261|NCT04536935|183251052|OTHER|||||||0.25|||||||Mixed Models Analysis|||||||.25
91679262|NCT04536935|183251053|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.22
91679263|NCT04536935|183251054|SUPERIORITY|||||||0.48|||||||ANOVA|||||||.48
91679264|NCT04536935|183251055|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<.0001
91679265|NCT02731326|183251072|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05).|Hazard Ratio (HR)|1.56||||0.05|TWO_SIDED|95.0|1.06|2.3|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05). Kaplan-Meier curves were created for recurrence detection in the intervention and control groups over the 6-month follow-up period. Differences in time to recurrence between groups were assessed using a Cox proportional hazards model. Baseline variables that differed significantly between groups were included as covariates and adjusted Kaplan-Meier curves were constructed.||2.30|1.06|0.05
91679266|NCT02731326|183251073|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 (α = .05).|Hazard Ratio (HR)|0.33||||0.05|TWO_SIDED|95.0|0.09|0.58|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|Kaplan-Meier curves were created for assessing time to treatment for intervention and control groups. Time to treatment was defined as the time interval from detection of a recurrent arrhythmia to treatment for that arrhythmia.||0.58|0.09|0.05
91679267|NCT02731326|183251074|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.58|||Regression, Cox|||||0.58|0.19|<.0001
91679268|NCT02731326|183251075|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91679269|NCT02731326|183251076|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
91679270|NCT02994940|183251084|SUPERIORITY||Hodges Lehman estimator|21.3||||0.127|TWO_SIDED|95.0|-2.5|44.2|||Wilcoxon (Mann-Whitney)|||||44.2|-2.5|0.127
91679271|NCT02994940|183251085|SUPERIORITY|||||||0.851|||||||Chi-squared|||||||0.851
91679272|NCT02994940|183251086|SUPERIORITY||Hodges Lehman estimator|2.0||||0.109|TWO_SIDED|95.0|-1.0|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-1.0|0.109
91679273|NCT02994940|183251087|SUPERIORITY||Hodges Lehman estimator|7.0||||0.0001|TWO_SIDED|95.0|4.0|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|4.0|0.0001
91679274|NCT00899470|183251140|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.011|||||TWO_SIDED|90.0|0.94|1.088|||Mixed Models Analysis|Bioequivalence=90% confidence intervals (CIs) for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.940|
91679275|NCT00899470|183251140|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs Reference|0.999|||||TWO_SIDED|90.0|0.929|1.075||||Bioequivalence=90% CIs for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.075|0.929|
91717666|NCT01329198|183328099|SUPERIORITY||Mean Difference (Final Values)|-17.8|STANDARD_DEVIATION|9.4||0.013|TWO_SIDED||||||ANOVA||Mean change in YGTSS scores from Baseline to 6 Months across all study participants presented.|||||0.013
91487107|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.967|||||TWO_SIDED|95.0|0.84|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.99|0.84|
91679276|NCT00899470|183251141|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.993|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.993|
91679277|NCT00899470|183251141|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio|1.021|||||TWO_SIDED|90.0|0.986|1.058|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.058|0.986|
91679278|NCT00899470|183251142|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.027|||||TWO_SIDED|90.0|0.99|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.990|
91679279|NCT00899470|183251142|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio Test vs. Reference|1.022|||||TWO_SIDED|95.0|0.985|1.06|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.060|0.985|
91679280|NCT00899470|183251144|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.|Geometric Mean Ratio, Test vs. Reference|1.009|||||TWO_SIDED|90.0|0.939|1.084|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.084|0.939|
91679281|NCT00899470|183251144|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.|Geometric Mean Ratio, Test vs. Reference|1.034|||||TWO_SIDED|90.0|0.962|1.111|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.111|0.962|
91487108|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.965|||||TWO_SIDED|95.0|-0.04|0.99|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Fast Speed: ActiGraph vs GAITRite vs APDM||0.99|-0.04|
91487109|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.709|||||TWO_SIDED|95.0|0.26|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.90|0.26|
91679282|NCT00899470|183251145|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.024|||||TWO_SIDED|90.0|0.964|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.964|
91679283|NCT00899470|183251145|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.981|1.108|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.108|0.981|
91679284|NCT00899470|183251146|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.973|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.973|
91679285|NCT00899470|183251146|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.986|1.102|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.102|0.986|
91679286|NCT03456960|183251165|EQUIVALENCE|The difference in the least square means (LSM) between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0059|||||TWO_SIDED|90.0|-0.034|0.0458||||||||0.0458|-0.0340|
91679287|NCT03456960|183251166|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0508|||||TWO_SIDED|90.0|-0.0079|0.1096||||||||0.1096|-0.0079|
91679288|NCT03456960|183251167|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0546|||||TWO_SIDED|90.0|-0.0941|0.2034||||||||0.2034|-0.0941|
91487110|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.48|||||TWO_SIDED|95.0|-0.07|0.8|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.80|-0.07|
91487111|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.655|||||TWO_SIDED|95.0|0.15|0.88|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite||0.88|0.15|
91487112|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.692|||||TWO_SIDED|95.0|0.18|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.90|0.18|
91527570|NCT01976364|182930468|OTHER||LS Mean Difference|0.0325|||||TWO_SIDED|95.0|-0.0372|0.1021||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1021|-0.0372|
91679289|NCT03456960|183251167|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model will include a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0912|||||TWO_SIDED|90.0|0.0399|0.1424||||||||0.1424|0.0399|
91679290|NCT03456960|183251168|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0916|||||TWO_SIDED|90.0|-0.133|0.3162||||||||0.3162|-0.1330|
91679291|NCT03456960|183251168|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.2293|||||TWO_SIDED|90.0|0.1519|0.3068||||||||0.3068|0.1519|
91679292|NCT03456960|183251169|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.01|||||TWO_SIDED|90.0|-0.0299|0.05||||||||0.0500|-0.0299|
91679293|NCT03456960|183251170|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0281|||||TWO_SIDED|90.0|-0.1662|0.11||||||||0.1100|-0.1662|
91679294|NCT03456960|183251171|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.015|||||TWO_SIDED|90.0|-0.0448|0.0149||||||||0.0149|-0.0448|
91679295|NCT03456960|183251172|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0195|||||TWO_SIDED|90.0|-0.0676|0.0286||||||||0.0286|-0.0676|
91679296|NCT03456960|183251173|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0547|||||TWO_SIDED|90.0|-0.0937|0.2032||||||||0.2032|-0.0937|
91679297|NCT03456960|183251173|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0654|||||TWO_SIDED|90.0|0.0141|0.1167||||||||0.1167|0.0141|
91679298|NCT03456960|183251174|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.146|||||TWO_SIDED|90.0|-0.2478|-0.0443||||||||-0.0443|-0.2478|
91679299|NCT03456960|183251174|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1674|||||TWO_SIDED|90.0|-0.2084|-0.1264||||||||-0.1264|-0.2084|
91679300|NCT03456960|183251175|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1193|||||TWO_SIDED|90.0|-0.2179|-0.0206||||||||-0.0206|-0.2179|
91679301|NCT03456960|183251175|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1366|||||TWO_SIDED|90.0|-0.173|-0.1002||||||||-0.1002|-0.1730|
91679302|NCT03456960|183251176|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0148|||||TWO_SIDED|90.0|-0.0734|0.103||||||||0.1030|-0.0734|
91487113|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.494|||||TWO_SIDED|95.0|-0.05|0.81|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.81|-0.05|
91527571|NCT01976364|182930468|OTHER||LS Mean Difference|-0.0058|||||TWO_SIDED|95.0|-0.0941|0.0825||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0825|-0.0941|
91679303|NCT03456960|183251176|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.002|||||TWO_SIDED|90.0|-0.0463|0.0424||||||||0.0424|-0.0463|
91679304|NCT03456960|183251177|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2138|||||TWO_SIDED|90.0|0.1609|0.2667||||||||0.2667|0.1609|
91679305|NCT03456960|183251178|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2161|||||TWO_SIDED|90.0|0.1652|0.2671||||||||0.2671|0.1652|
91679306|NCT03456960|183251179|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.219|||||TWO_SIDED|90.0|0.1675|0.2706||||||||0.2706|0.1675|
91679307|NCT03456960|183251180|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.3653|||||TWO_SIDED|90.0|0.218|0.5126||||||||0.5126|0.2180|
91679308|NCT03456960|183251183|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2089|||||TWO_SIDED|90.0|-0.0061|0.4239||||||||0.4239|-0.0061|
91679309|NCT03456960|183251183|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.014|||||TWO_SIDED|90.0|-0.0639|0.0918||||||||0.0918|-0.0639|
91679310|NCT03456960|183251184|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2099|||||TWO_SIDED|90.0|-0.0048|0.4246||||||||0.4246|-0.0048|
91679311|NCT03456960|183251184|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0137|||||TWO_SIDED|90.0|-0.0712|0.0986||||||||0.0986|-0.0712|
91679312|NCT03456960|183251185|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2096|||||TWO_SIDED|90.0|-0.0054|0.4246||||||||0.4246|-0.0054|
91487114|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.648|||||TWO_SIDED|95.0|0.16|0.88|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs APDM||0.88|0.16|
91487115|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.82|||||TWO_SIDED|95.0|0.57|0.94|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.94|0.57|
91679313|NCT03456960|183251185|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0201|||||TWO_SIDED|90.0|-0.069|0.1092||||||||0.1092|-0.0690|
91487116|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.689|||||TWO_SIDED|95.0|0.3|0.89|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.89|0.30|
91679314|NCT03456960|183251186|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.4058|||||TWO_SIDED|90.0|0.0803|0.7312||||||||0.7312|0.0803|
91679315|NCT03456960|183251186|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.1969|||||TWO_SIDED|90.0|0.1065|0.2873||||||||0.2873|0.1065|
91679316|NCT00446199|183251223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679317|NCT00446199|183251223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679318|NCT00446199|183251223|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
91679319|NCT00446199|183251224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/ van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679320|NCT00446199|183251224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679321|NCT00446199|183251224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679322|NCT00446199|183251225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679323|NCT00446199|183251225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91487117|NCT04823650|182846751|OTHER||Intraclass correlation coefficient|0.79|||||TWO_SIDED|95.0|0.53|0.93|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Walk at Slow Speed: ActiGraph vs GAITRite vs APDM||0.93|0.53|
91679324|NCT00446199|183251225|SUPERIORITY_OR_OTHER|||||||0.0096||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0096
91679325|NCT00446199|183251226|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91487118|NCT04823650|182846752|OTHER||Intraclass correlation coefficient|0.03|||||TWO_SIDED|95.0|-0.2|0.4|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.40|-0.20|
91487119|NCT04823650|182846752|OTHER||Intraclass correlation coefficient|0.096|||||TWO_SIDED|95.0|-0.22|0.5|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.50|-0.22|
91487120|NCT04823650|182846752|OTHER||Intraclass correlation coefficient|0.188|||||TWO_SIDED|95.0|-0.05|0.64|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.64|-0.05|
91487121|NCT04823650|182846752|OTHER||Intraclass correlation coefficient|0.026|||||TWO_SIDED|95.0|-0.18|0.39|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.39|-0.18|
91487122|NCT04823650|182846752|OTHER||Intraclass correlation coefficient|0.049|||||TWO_SIDED|95.0|-0.07|0.3|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.30|-0.07|
91487123|NCT04823650|182846752|OTHER||Intraclass correlation coefficient|0.144|||||TWO_SIDED|95.0|-0.04|0.57|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.57|-0.04|
91487124|NCT04823650|182846753|OTHER||Intraclass correlation coefficient|0.123|||||TWO_SIDED|95.0|-0.16|0.51|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.51|-0.16|
91487125|NCT04823650|182846753|OTHER||Intraclass correlation coefficient|0.473|||||TWO_SIDED|95.0|-0.04|0.86|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.86|-0.04|
91487126|NCT04823650|182846753|OTHER||Intraclass correlation coefficient|0.293|||||TWO_SIDED|95.0|-0.03|0.74|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.74|-0.03|
91487127|NCT04823650|182846753|OTHER||Intraclass correlation coefficient|0.277|||||TWO_SIDED|95.0|-0.15|0.73|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.73|-0.15|
91487128|NCT04823650|182846753|OTHER||Intraclass correlation coefficient|0.377|||||TWO_SIDED|95.0|-0.04|0.8|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.80|-0.04|
91487129|NCT04823650|182846753|OTHER||Intraclass correlation coefficient|0.279|||||TWO_SIDED|95.0|-0.03|0.73|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.73|-0.03|
91487130|NCT04823650|182846754|OTHER||Intraclass correlation coefficient|0.252|||||TWO_SIDED|95.0|-0.31|0.69|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: Actigraph Lumbar vs APDM||0.69|-0.31|
91487131|NCT04823650|182846754|OTHER||Intraclass correlation coefficient|0.704|||||TWO_SIDED|95.0|0.3|0.89|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: Actigraph Lumbar vs APDM||0.89|0.30|
91527572|NCT01976364|182930468|OTHER||LS Mean Difference|0.0096|||||TWO_SIDED|95.0|-0.0734|0.0927||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0927|-0.0734|
91487132|NCT04823650|182846754|OTHER||Intraclass correlation coefficient|0.631|||||TWO_SIDED|95.0|-0.09|0.92|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: Actigraph Lumbar vs APDM||0.92|-0.09|
91487133|NCT04823650|182846754|OTHER||Intraclass correlation coefficient|0.292|||||TWO_SIDED|95.0|-0.18|0.69|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: Actigraph Lumbar vs APDM||0.69|-0.18|
91487134|NCT04823650|182846754|OTHER||Intraclass correlation coefficient|0.516|||||TWO_SIDED|95.0|-0.07|0.82|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: Actigraph Lumbar vs APDM||0.82|-0.07|
91487135|NCT04823650|182846754|OTHER||Intraclass correlation coefficient|0.566|||||TWO_SIDED|95.0|-0.04|0.9|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: Actigraph Lumbar vs APDM||0.90|-0.04|
91487136|NCT04823650|182846755|OTHER||Intra-class correlation coefficient|0.132|||||TWO_SIDED|95.0|-0.16|0.52|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.52|-0.16|
91487137|NCT04823650|182846755|OTHER||Intra-class correlation coefficient|0.522|||||TWO_SIDED|95.0|-0.06|0.88|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.88|-0.06|
91487138|NCT04823650|182846755|OTHER||Intra-class correlation coefficient|0.363|||||TWO_SIDED|95.0|-0.06|0.8|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.80|-0.06|
91487139|NCT04823650|182846755|OTHER||Intraclass correlation coefficient|0.456|||||TWO_SIDED|95.0|-0.21|0.84|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.84|-0.21|
91526781|NCT01598298|182929045|OTHER|Two-sided test at the alpha=0.05 level|Coefficient fro treatment term|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.||-0.55|-1.35|<0.0001
91526782|NCT04105972|182929048|SUPERIORITY||Least Squares (LS) Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.7|20.1|||Mixed-effects Model for Repeated Measure|||||20.1|11.7|< 0.0001
91526783|NCT04105972|182929049|SUPERIORITY||LS Mean Difference|10.2|||<|0.0001|TWO_SIDED|95.0|8.2|12.1|||Mixed-effects Model for Repeated Measure|||||12.1|8.2|<0.0001
91526784|NCT04105972|182929050|SUPERIORITY||LS Mean Difference|-42.8|||||TWO_SIDED|95.0|-46.2|-39.3||||||||-39.3|-46.2|
91487140|NCT04823650|182846755|OTHER||Intraclass correlation coefficient|0.461|||||TWO_SIDED|95.0|-0.02|0.85|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.85|-0.02|
91679326|NCT00446199|183251226|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91487141|NCT04823650|182846755|OTHER||Intraclass correlation coefficient|0.292|||||TWO_SIDED|95.0|-0.06|0.75|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.75|-0.06|
91487142|NCT04823650|182846756|OTHER||Intraclass correlation coefficient|-0.043|||||TWO_SIDED|95.0|-0.24|0.31|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.31|-0.24|
91487143|NCT04823650|182846756|OTHER||Intraclass correlation coefficient|0.284|||||TWO_SIDED|95.0|-0.19|0.68|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.68|-0.19|
91526785|NCT00474929|182929101|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose (MTD) Level|1.0|||||TWO_SIDED||||||||Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).||||
91526786|NCT03029247|182929107|SUPERIORITY||LS Mean Difference|-0.17||||0.9694|TWO_SIDED|95.0|-8.8|8.47||p-value for the difference between treatment groups were presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% confidence interval (CI) has been presented.|||8.47|-8.80|0.9694
91526787|NCT03029247|182929108|SUPERIORITY||LS Mean Difference|-1.32||||0.7745|TWO_SIDED|95.0|-10.46|7.83||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of SBP and its corresponding 95% CI has been presented.|||7.83|-10.46|0.7745
91526788|NCT03029247|182929108|SUPERIORITY||LS Mean Difference|-1.95||||0.291|TWO_SIDED|95.0|-5.62|1.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||1.71|-5.62|0.2910
91679327|NCT00446199|183251226|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
91679328|NCT00446199|183251227|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679329|NCT00446199|183251227|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91487144|NCT04823650|182846756|OTHER||Intraclass correlation coefficient|0.332|||||TWO_SIDED|95.0|-0.17|0.72|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.72|-0.17|
91679330|NCT00446199|183251227|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3 mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91487145|NCT04823650|182846756|OTHER||Intraclass correlation coefficient|0.041|||||TWO_SIDED|95.0|-0.22|0.44|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.44|-0.22|
91679331|NCT00446199|183251228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679332|NCT00446199|183251228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679333|NCT00446199|183251228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
91679334|NCT00446199|183251229|SUPERIORITY_OR_OTHER|||||||0.0314||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0314
91679335|NCT00446199|183251229|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8780
91679336|NCT00446199|183251229|SUPERIORITY_OR_OTHER|||||||0.5908||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.5908
91679337|NCT00446199|183251230|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0027
91679338|NCT00446199|183251230|SUPERIORITY_OR_OTHER|||||||0.4463||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4463
91679339|NCT00446199|183251230|SUPERIORITY_OR_OTHER|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0303
91487146|NCT04823650|182846756|OTHER||Intraclass correlation coefficient|0.289|||||TWO_SIDED|95.0|-0.18|0.68|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.68|-0.18|
91487147|NCT04823650|182846756|OTHER||Intraclass correlation coefficient|0.306|||||TWO_SIDED|95.0|-0.18|0.7|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.70|-0.18|
91487148|NCT04823650|182846757|OTHER||Intraclass correlation coefficient|0.596|||||TWO_SIDED|95.0|0.08|0.86|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.86|0.08|
91487149|NCT04823650|182846757|OTHER||Intraclass correlation coefficient|0.902|||||TWO_SIDED|95.0|0.72|0.97|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.97|0.72|
91679340|NCT00446199|183251231|SUPERIORITY_OR_OTHER|||||||0.4397||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4397
91679341|NCT00446199|183251231|SUPERIORITY_OR_OTHER|||||||0.0132||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0132
91679342|NCT00446199|183251231|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.3250
91679343|NCT00446199|183251232|SUPERIORITY_OR_OTHER|||||||0.9555||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.9555
91679344|NCT00446199|183251232|SUPERIORITY_OR_OTHER|||||||0.1743||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.1743
91679345|NCT00446199|183251232|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4395
91679346|NCT00446199|183251233|SUPERIORITY_OR_OTHER|||||||0.8966||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8966
91679347|NCT00446199|183251233|SUPERIORITY_OR_OTHER|||||||0.7512||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.7512
91679348|NCT00446199|183251233|SUPERIORITY_OR_OTHER|||||||0.8751||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8751
91679349|NCT00446199|183251234|SUPERIORITY_OR_OTHER|||||||0.1067||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.1067
91679350|NCT00446199|183251234|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.6011
91487150|NCT04823650|182846757|OTHER||Intraclass correlation coefficient|0.944|||||TWO_SIDED|95.0|-0.15|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.99|-0.15|
91679351|NCT00446199|183251234|SUPERIORITY_OR_OTHER|||||||0.4408||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.4408
91679352|NCT00446199|183251235|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.0144
91679353|NCT00446199|183251235|SUPERIORITY_OR_OTHER|||||||0.5589||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5589
91679354|NCT00446199|183251235|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5500
91679355|NCT00446199|183251236|SUPERIORITY_OR_OTHER|||||||0.2179||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.2179
91679356|NCT00446199|183251236|SUPERIORITY_OR_OTHER|||||||0.7749||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.7749
91679357|NCT00446199|183251236|SUPERIORITY_OR_OTHER|||||||0.8307||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.8307
91679358|NCT00446199|183251237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|||<|0.0001||95.0|-33.2|-22.0||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-22.0|-33.2|<0.0001
91679359|NCT00446199|183251237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||<|0.0001||95.0|-27.8|-16.6||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-16.6|-27.8|<0.0001
91679360|NCT00446199|183251237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8||||0.0007||95.0|-15.4|-4.2||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline||-4.2|-15.4|0.0007
91679361|NCT00446199|183251238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||<|0.0001||95.0|-29.9|17.8||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||17.8|-29.9|<0.0001
91679362|NCT00446199|183251238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.0001||95.0|-20.2|-8.1||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-8.1|-20.2|<0.0001
91679363|NCT00446199|183251238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0054||95.0|-14.6|-2.5||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-2.5|-14.6|0.0054
91679364|NCT00446199|183251239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|||<|0.0001||95.0|-1.28|-0.859||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.859|-1.280|<0.0001
91679365|NCT00446199|183251239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803|||<|0.0001||95.0|-1.013|-0.593||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.593|-1.013|<0.0001
91679366|NCT00446199|183251239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361||||0.0007||95.0|-0.57|-0.152||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.152|-0.570|0.0007
91679367|NCT00446199|183251240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||<|0.0001||95.0|-0.813|-0.458||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.458|-0.813|<0.0001
91679368|NCT00446199|183251240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|||<|0.0001||95.0|-0.56|-0.205||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.205|-0.560|<0.0001
91679369|NCT00446199|183251240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0233||95.0|-0.381|-0.028||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between E2 (0.3) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.028|-0.381|0.0233
91679370|NCT01822574|183251241|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.001
91679371|NCT01822574|183251242|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||<0.001
91679372|NCT01822574|183251243|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.240
91679373|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.308|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.308
91679374|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.415|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.415
91679375|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.335|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.335
91679376|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.120
91679377|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.061|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.061
91487151|NCT04823650|182846757|OTHER||Intraclass correlation coefficient|0.614|||||TWO_SIDED|95.0|0.1|0.87|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.87|0.10|
91679378|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.031
91679379|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.131
91679380|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.202|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.202
91679381|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.484|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.484
91679382|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.047
91679383|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.285|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.285
91679384|NCT01195272|183251269|SUPERIORITY_OR_OTHER|||||||0.315|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.315
91679385|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.288|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.288
91679386|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.318|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.318
91679387|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.400
91679388|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.317|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.317
91679389|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.137
91679390|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.052
91679391|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.354|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.354
91679392|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.266|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.266
91679393|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.378|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.378
91679394|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.422|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.422
91679395|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.444|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.444
91679396|NCT01195272|183251270|SUPERIORITY_OR_OTHER|||||||0.345|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.345
91679397|NCT01195272|183251271|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||Visit 3 versus Visit 2||||0.39
91679398|NCT01195272|183251271|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Visit 5 versus Visit 3||||0.08
91679399|NCT01195272|183251271|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
91679400|NCT01195272|183251272|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
91679401|NCT01195272|183251272|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||Visit 5 versus Visit 2||||0.30
91679402|NCT01195272|183251272|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANOVA|||Visit 5 versus Visit 3||||0.34
91679403|NCT01195272|183251273|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
91679404|NCT01195272|183251273|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 2||||0.44
91679405|NCT01195272|183251273|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANOVA|||Visit 5 versus Visit 3||||0.23
91679406|NCT01195272|183251274|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
91679407|NCT01195272|183251274|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Visit 5 versus Visit 2||||0.46
91679408|NCT01195272|183251274|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||Visit 5 versus Visit 3||||0.24
91679409|NCT01195272|183251275|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Visit 3 versus Visit 2||||0.05
91679410|NCT01195272|183251275|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||Visit 5 versus Visit 2||||0.01
91679411|NCT01195272|183251275|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
91679412|NCT01195272|183251276|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
91679413|NCT01195272|183251276|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||Visit 5 versus Visit 2||||0.43
91679414|NCT01195272|183251276|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 3||||0.44
91679415|NCT01195272|183251277|SUPERIORITY_OR_OTHER|||||||0.313|||||||ANOVA|||Visit 3 versus Visit 2||||0.313
91679416|NCT01195272|183251277|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||Visit 5 versus Visit 2||||0.083
91679417|NCT01195272|183251277|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|||Visit 5 versus Visit 3||||0.092
91679418|NCT01195272|183251277|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|||Visit 8 versus Visit 2||||0.145
91679419|NCT01195272|183251277|SUPERIORITY_OR_OTHER|||||||0.398|||||||ANOVA|||Visit 8 versus Visit 3||||0.398
91679420|NCT01195272|183251277|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANOVA|||Visit 8 versus Visit 5||||0.138
91487152|NCT04823650|182846757|OTHER||Intraclass correlation coefficient|0.882|||||TWO_SIDED|95.0|0.67|0.96|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.96|0.67|
91679421|NCT01195272|183251278|SUPERIORITY_OR_OTHER|||||||0.467|||||||ANOVA|||Visit 3 versus Visit 2||||0.467
91679422|NCT01195272|183251278|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Visit 5 versus Visit 2||||0.250
91679423|NCT01195272|183251278|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Visit 5 versus Visit 3||||0.060
91679424|NCT01195272|183251278|SUPERIORITY_OR_OTHER|||||||0.149|||||||ANOVA|||Visit 8 versus Visit 2||||0.149
91679425|NCT01195272|183251278|SUPERIORITY_OR_OTHER|||||||0.061|||||||ANOVA|||Visit 8 versus Visit 3||||0.061
91679426|NCT01195272|183251278|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANOVA|||Visit 8 versus Visit 5||||0.047
91679427|NCT01195272|183251279|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANOVA|||Visit 3 versus Visit 2||||0.169
91679428|NCT01195272|183251279|SUPERIORITY_OR_OTHER|||||||0.165|||||||ANOVA|||Visit 5 versus Visit 2||||0.165
91679429|NCT01195272|183251279|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANOVA|||Visit 5 versus Visit 3||||0.471
91679430|NCT01195272|183251279|SUPERIORITY_OR_OTHER|||||||0.243|||||||ANOVA|||Visit 8 versus Visit 2||||0.243
91679431|NCT01195272|183251279|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANOVA|||Visit 8 versus Visit 3||||0.396
91679432|NCT01195272|183251279|SUPERIORITY_OR_OTHER|||||||0.375|||||||ANOVA|||Visit 8 versus Visit 5||||0.375
91679433|NCT01195272|183251280|SUPERIORITY_OR_OTHER|||||||0.496|||||||ANOVA|||Visit 3 versus Visit 2||||0.496
91679434|NCT01195272|183251280|SUPERIORITY_OR_OTHER|||||||0.122|||||||ANOVA|||Visit 5 versus Visit 2||||0.122
91679435|NCT01195272|183251280|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Visit 5 versus Visit 3||||0.070
91679436|NCT01195272|183251280|SUPERIORITY_OR_OTHER|||||||0.135|||||||ANOVA|||Visit 8 versus Visit 2||||0.135
91679437|NCT01195272|183251280|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANOVA|||Visit 8 versus Visit 3||||0.082
91679438|NCT01195272|183251280|SUPERIORITY_OR_OTHER|||||||0.461|||||||ANOVA|||Visit 8 versus Visit 5||||0.461
91679439|NCT01769339|183251296|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91679440|NCT00290251|183251304|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|performed on log-transformed delta change in total fibroid volume from baseline to end of treatment||||||0.43
91679441|NCT00290251|183251304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|95.0|||||ANOVA|Performed on log-transformed delta change||Ulipristal acetate groups one and two were first compared and found to be similar (see statistical analysis 1), so they were combined into a single treatment group for comparison to placebo group||||0.003
91679442|NCT00290251|183251305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||The Delta of scores from treatment end to baseline was used to compare by ANOVA.|ANOVA|Adjustment for age||No sample size calculation was made.||||< 0.05
91679443|NCT04732221|183251325|SUPERIORITY||Treatment difference|-9.2||||0.068|TWO_SIDED|95.0|-21.3|2.9||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||2.9|-21.3|0.068
91679444|NCT04732221|183251325|SUPERIORITY||Treatment difference|-22.0|||<|0.001|TWO_SIDED|95.0|-33.7|-10.3||based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-10.3|-33.7|<0.001
91679445|NCT04732221|183251325|SUPERIORITY||Treatment difference|-19.9||||0.002|TWO_SIDED|95.0|-33.4|-6.4||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-6.4|-33.4|0.002
91679446|NCT03611543|183251337|SUPERIORITY||||||<|0.0001||||||Information related to the INVESTIGATIONAL group.|Wilcoxon Rank-Sum test|||||||<0.0001
91679447|NCT05538065|183251368|SUPERIORITY||Risk Ratio (RR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.78||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.78|1.10|0.002
91679448|NCT05538065|183251368|SUPERIORITY||Risk Ratio (RR)|1.26||||0.039|TWO_SIDED|95.0|1.01|1.57||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.57|1.01|0.039
91679449|NCT05538065|183251369|SUPERIORITY||Mean Difference (Final Values)|29.0||||0.386|TWO_SIDED|95.0|-36.6|94.6||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||94.6|-36.6|0.386
91679450|NCT05538065|183251369|SUPERIORITY||Mean Difference (Final Values)|38.1||||272|TWO_SIDED|95.0|-29.9|106.1||Adjusted for multiple comparisons|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||106.1|-29.9|272
91679451|NCT05538065|183251370|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.657|TWO_SIDED|95.0|-74.5|47.0||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||47.0|-74.5|0.657
91679452|NCT05538065|183251370|SUPERIORITY||Mean Difference (Final Values)|15.1||||0.696|TWO_SIDED|95.0|-60.7|91.0|||Regression, Linear|Adjusted for multiple testing||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||91.0|-60.7|0.696
91679453|NCT00292188|183251411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.01||95.0|-1.09|-0.15|||ANCOVA|ANCOVA adjusted for treatment group, baseline mean pain score and pooled country||The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.||-0.15|-1.09|0.010
91679454|NCT00292188|183251412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.39||0.031||95.0|-1.6|-0.08|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.08|-1.60|0.031
91679455|NCT00292188|183251413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.003||95.0|-1.61|-0.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.33|-1.61|0.003
91679456|NCT00292188|183251414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|1.0||0.099||95.0|-3.69|0.32|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||0.32|-3.69|0.099
91679457|NCT00292188|183251415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|1.03||0.819||95.0|-1.87|2.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||2.34|-1.87|0.819
91679458|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.099||95.0|-0.56|0.05|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 1||0.05|-0.56|0.099
91679459|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.15||95.0|-0.62|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 2: FAS||0.10|-0.62|0.150
91679460|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01||95.0|-0.93|-0.13|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 3: FAS||-0.13|-0.93|0.010
91679461|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.137||95.0|-0.74|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 4: FAS||0.10|-0.74|0.137
91679462|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.041||95.0|-0.9|-0.02|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 5: FAS||-0.02|-0.90|0.041
91679463|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.009||95.0|-1.03|-0.15|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 6: FAS||-0.15|-1.03|0.009
91679464|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.25||0.035||95.0|-1.01|-0.04|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 7: FAS||-0.04|-1.01|0.035
91679465|NCT00292188|183251416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.019||95.0|-1.1|-0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 8: FAS||-0.10|-1.10|0.019
91679466|NCT00292188|183251417|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.032||95.0|1.05|3.21|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||30% responder||3.21|1.05|0.032
91679467|NCT00292188|183251417|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.78||||0.088||95.0|0.92|3.46|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||50% responder||3.46|0.92|0.088
91679468|NCT00292188|183251418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|-1.25|-0.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.34|-1.25|0.001
91679469|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|2.62||0||95.0|-15.89|-5.55|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Disturbance||-5.55|-15.89|0.000
91679470|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|2.71||0.7||95.0|-4.3|6.4|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Snoring||6.40|-4.30|0.700
91679471|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|2.88||0.04||95.0|-11.62|-0.28|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Awaken Short of Breath/Headache||-0.28|-11.62|0.040
91679472|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.846||95.0|-0.92|0.76|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Quantity||0.76|-0.92|0.846
91679473|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.27||0.001||95.0|4.19|17.07|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Adequacy||17.07|4.19|0.001
91679474|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|2.34||0.324||95.0|-2.3|6.92|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Somnolence||6.92|-2.30|0.324
91679475|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|2.63||0||95.0|-14.71|-4.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-6||-4.33|-14.71|0.000
91679476|NCT00292188|183251419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.02||0||95.0|-11.52|-3.56|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-9||-3.56|-11.52|0.000
91679477|NCT00292188|183251420|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.267||95.0|0.76|2.64|||Regression, Logistic|Logistic regression adjusted for treatment group, baseline score and pooled country.||||2.64|0.76|0.267
91679478|NCT00292188|183251428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.84|STANDARD_ERROR_OF_MEAN|2.25||0.09||95.0|-8.28|0.61|||ANCOVA|||||0.61|-8.28|0.090
91679479|NCT00824616|183251438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.745|TWO_SIDED|95.0|-0.81|0.58|||Longitudinal Data Analysis (LDA) model|||||0.58|-0.81|0.745
91679480|NCT00824616|183251439|SUPERIORITY_OR_OTHER||Proportions|5.9||||0.537|TWO_SIDED|95.0|-13.7|25.4|||Miettinen & Nurminen method|||Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.||25.4|-13.7|0.537
91679481|NCT04711902|183251449|OTHER|estimation and confidence interval|Marginal difference|39.91|||||TWO_SIDED|95.0|10.87|68.95|||Regression, Logistic|||||68.95|10.87|
91679482|NCT04711902|183251450|OTHER|estimation and confidence interval|Marginal difference|11.86|||||TWO_SIDED|95.0|-7.18|30.91|||Regression, Logistic|||||30.91|-7.18|
91679483|NCT04711902|183251451|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.1|||||TWO_SIDED|95.0|-1.68|-0.52|||Mixed Models Analysis|||||-0.52|-1.68|
91679484|NCT04711902|183251452|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.65|||||TWO_SIDED|95.0|-2.35|-0.94|||Mixed Models Analysis|||||-0.94|-2.35|
91679485|NCT04711902|183251453|OTHER|estimation and confidence interval|Mixed model repeated scores (MMRM)|4.2|||||TWO_SIDED|95.0|0.94|7.46|||Mixed Models Analysis|||||7.46|0.94|
91679486|NCT04711902|183251454|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-0.4|||||TWO_SIDED|95.0|-0.58|-0.21|||Mixed Models Analysis|||||-0.21|-0.58|
91679487|NCT03786718|183251455|OTHER||||||<|0.001|||||||One sample median test|||Due to nonnormality, we used nonparametric tests to analyze the data. This analysis is a one sample median test of participants' median SUS score compared to the threshold score of 68 indicative of 'above average' usability.||||<0.001
91487153|NCT04823650|182846757|OTHER||Intraclass correlation coefficient|0.939|||||TWO_SIDED|95.0|-0.05|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.99|-0.05|
91679488|NCT03786718|183251459|OTHER|||||||0.77|||||||Wilcoxon Signed Rank Sum test|||||||0.77
91679489|NCT03786718|183251460|OTHER|||||||0.02|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in General Diet sub-scale score||||0.02
91679490|NCT03786718|183251460|OTHER|||||||0.13|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Specific Diet sub-scale score||||0.13
91679491|NCT03786718|183251460|OTHER|||||||0.35|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Exercise sub-scale score||||0.35
91679492|NCT03786718|183251460|OTHER|||||||0.67|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Blood-glucose Testing sub-scale score||||0.67
91679493|NCT03786718|183251460|OTHER|||||||0.65|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Foot Care sub-scale score||||0.65
91679494|NCT03786718|183251461|OTHER|||||||0.001|||||||Wilcoxon Signed Rank Sum test|||||||0.001
91679495|NCT03786718|183251462|OTHER|||||||0.86|||||||Wilcoxon Signed Rank Sum test|||||||0.86
91679496|NCT03786718|183251463|OTHER|||||||0.3|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.30
91679497|NCT03786718|183251463|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||1.00
91679498|NCT03786718|183251463|OTHER|||||||0.63|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.63
91679499|NCT03786718|183251463|OTHER|||||||0.02|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.02
91679500|NCT03786718|183251463|OTHER|||||||0.55|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.55
91679501|NCT03786718|183251463|OTHER|||||||0.0009|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.0009
91679502|NCT03786718|183251463|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
91679503|NCT03786718|183251463|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||1.00
91679504|NCT03786718|183251464|OTHER|||||||0.15|||||||Wilcoxon Signed Rank Sum test|||||||0.15
91679505|NCT03786718|183251465|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.23
91679506|NCT03786718|183251465|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||1.00
91679507|NCT03786718|183251465|OTHER|||||||0.51|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.'||||0.51
91679508|NCT03786718|183251465|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.63
91679509|NCT03786718|183251466|OTHER|||||||0.01|||||||Wilcoxon Signed Rank Sum test|||||||0.01
91679510|NCT03244644|183251467|SUPERIORITY||Treatment Difference|13.1|||||TWO_SIDED|95.0|2.3|24.0|||||The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).|A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.||24.0|2.3|
91679511|NCT03244644|183251468|SUPERIORITY|||||||0.156||||||P-value for secondary outcome evaluated from baseline through 6 months|Chi-squared|||||||0.156
91679512|NCT00123474|183251484|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-6.0|11.6||||||6 Month Analysis||11.6|-6.0|
91679513|NCT00123474|183251485|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-6.8|10.6||||||||10.6|-6.8|
91679514|NCT00123474|183251485|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-8.9|8.5||||||||8.5|-8.9|
91679515|NCT00123474|183251496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-11.7|15.3||||||6 Month Analysis||15.3|-11.7|
91679516|NCT00123474|183251496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-9.3|17.6||||||6 Month Analysis||17.6|-9.3|
91679517|NCT00123474|183251496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
91679518|NCT00123474|183251496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
91679519|NCT01059344|183251506|SUPERIORITY_OR_OTHER|||||||0.069|||||||Chi-squared|||||||0.069
91679520|NCT01059344|183251507|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91679521|NCT01059344|183251508|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91679522|NCT01059344|183251509|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
91679523|NCT01059344|183251510|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91679524|NCT01059344|183251511|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91679525|NCT01059344|183251512|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
91679526|NCT05472662|183251520|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|1.86||||0.113|TWO_SIDED|95.0|-0.48|4.2|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||4.20|-0.48|0.113
91679527|NCT05472662|183251521|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.58||||0.483|TWO_SIDED|95.0|-1.1|2.25|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||2.25|-1.10|0.483
91679528|NCT05472662|183251521|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.23||||0.782|TWO_SIDED|95.0|-1.45|1.9|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.90|-1.45|0.782
91679529|NCT05472662|183251521|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.4||||0.599|TWO_SIDED|95.0|-1.97|1.16|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.16|-1.97|0.599
91679530|NCT05472662|183251521|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.13||||0.815|TWO_SIDED|95.0|-1.24|0.99|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.99|-1.24|0.815
91487154|NCT04823650|182846758|OTHER||Intraclass correlation coefficient|0.487|||||TWO_SIDED|95.0|-0.06|0.81|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.81|-0.06|
91679531|NCT05472662|183251521|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.69||||0.294|TWO_SIDED|95.0|-2.01|0.64|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.64|-2.01|0.294
91679532|NCT05472662|183251522|OTHER||Adjusted mean difference|0.015||||0.519|TWO_SIDED|95.0|-0.032|0.061|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.061|-0.032|0.519
91679533|NCT05472662|183251522|OTHER||Adjusted mean difference|0.061||||0.085|TWO_SIDED|95.0|-0.009|0.13|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.130|-0.009|0.085
91679534|NCT05472662|183251522|OTHER||Adjusted mean difference|0.004||||0.858|TWO_SIDED|95.0|-0.045|0.054|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.054|-0.045|0.858
91679535|NCT05472662|183251522|OTHER||Adjusted mean difference|-0.011||||0.632|TWO_SIDED|95.0|-0.058|0.036|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.036|-0.058|0.632
91679536|NCT05472662|183251522|OTHER||Adjusted mean difference|-0.003||||0.846|TWO_SIDED|95.0|-0.038|0.031|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.031|-0.038|0.846
91679537|NCT05472662|183251522|OTHER||Adjusted mean difference|-0.024||||0.282|TWO_SIDED|95.0|-0.068|0.021|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.021|-0.068|0.282
91679538|NCT04558918|183251575|SUPERIORITY||Odds Ratio (OR)|338.25|||<|0.0001|TWO_SIDED|95.0|25.07|4564.14||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||4564.14|25.07|<0.0001
91679539|NCT04558918|183251575|SUPERIORITY||Difference in marginal proportion|80.2|||||TWO_SIDED|95.0|71.2|87.6||||||||87.6|71.2|
91679540|NCT04558918|183251576|SUPERIORITY||Odds Ratio (OR)|495.74|||<|0.0001|TWO_SIDED|95.0|24.41|10066.53||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||10066.53|24.41|<0.0001
91679541|NCT04558918|183251576|SUPERIORITY||Diff. in marginal proportion|67.0|||||TWO_SIDED|95.0|56.4|76.9||||||||76.9|56.4|
91679542|NCT04558918|183251579|OTHER||Adjusted mean difference|-0.01|||||TWO_SIDED|95.0|-0.53|0.51||||||||0.51|-0.53|
91679543|NCT04558918|183251580|OTHER||Adjusted mean difference|-1.17|||||TWO_SIDED|95.0|-4.01|1.68||||||||1.68|-4.01|
91679544|NCT04558918|183251581|SUPERIORITY||Odds Ratio (OR)|108.41|||<|0.0001|TWO_SIDED|95.0|17.25|681.24||two sided unadjusted p-value|Conditional logistic regression|||||681.24|17.25|<0.0001
91679545|NCT04558918|183251581|SUPERIORITY||Diff. in marginal proportion|68.9|||||TWO_SIDED|95.0|51.4|83.9||||||logistic regression model||83.9|51.4|
91679546|NCT04558918|183251582|SUPERIORITY||Adjusted mean diff.|3.66|||<|0.0001|TWO_SIDED|95.0|3.2|4.12||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||4.12|3.20|<0.0001
91679547|NCT04558918|183251583|SUPERIORITY||Mean Difference (Net)|8.29|||<|0.0001|TWO_SIDED|95.0|5.28|11.29||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||11.29|5.28|<0.0001
91679548|NCT04558918|183251584|SUPERIORITY||Mean Difference (Net)|-116.15|||<|0.0001|TWO_SIDED|95.0|-132.04|-100.26||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||-100.26|-132.04|<0.0001
91679549|NCT04558918|183251585|SUPERIORITY||Geometric mean ratio|0.99||||0.8361|TWO_SIDED|95.0|0.89|1.1||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||1.10|0.89|0.8361
91679550|NCT04558918|183251586|SUPERIORITY||Rate ratio|0.1||||0.01183|TWO_SIDED|95.0|0.02|0.61||two sided unadjusted p-value|Negative binomial model|||||0.61|0.02|0.01183
91679551|NCT04558918|183251586|SUPERIORITY||Rate difference|-0.6|||||TWO_SIDED|95.0|-1.24|0.04||||||||0.04|-1.24|
91679552|NCT04558918|183251587|SUPERIORITY||rate difference|0.03||||0.31731|TWO_SIDED|95.0|-0.03|0.1||two sided unadjusted p-value|Poisson model|||||0.10|-0.03|0.31731
91679553|NCT04558918|183251588|OTHER||Adjusted mean difference|1.69|||||TWO_SIDED|95.0|-16.86|20.23||||||||20.23|-16.86|
91679554|NCT04558918|183251589|OTHER||Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.97|1.3||||||||1.30|0.97|
91679555|NCT02256436|183251592|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.41648|TWO_SIDED|95.0|0.81|1.19||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - All Participants||1.19|0.81|0.41648
91679556|NCT02256436|183251593|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.00224|TWO_SIDED|95.0|0.59|0.91||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)||0.91|0.59|0.00224
91679557|NCT02256436|183251594|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.26443|TWO_SIDED|95.0|0.68|1.24||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - PD-L1 positive participants||1.24|0.68|0.26443
91679558|NCT02256436|183251595|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61||||0.00239|TWO_SIDED|95.0|0.43|0.86||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - PD-L1 positive participants||0.86|0.43|0.00239
91679559|NCT02256436|183251596|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.23958|TWO_SIDED|95.0|0.61|1.28||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - Strongly PD-L1 positive participants||1.28|0.61|0.23958
91679560|NCT02256436|183251597|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.00483|TWO_SIDED|95.0|0.37|0.88||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - Strongly PD-L1 positive participants||0.88|0.37|0.00483
91679561|NCT02256436|183251600|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|17.2||||0.00061|TWO_SIDED|95.0|6.8|29.4||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - Strongly PD-L1 Positive Participants||29.4|6.8|0.00061
91679562|NCT02256436|183251601|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|15.6||||0.00049|TWO_SIDED|95.0|6.5|25.7||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - PD-L1 Positive Participants||25.7|6.5|0.00049
91679563|NCT02256436|183251602|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|10.0||||0.00068|TWO_SIDED|95.0|3.9|16.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - All Participants||16.2|3.9|0.00068
91679564|NCT02256436|183251603|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.07066|TWO_SIDED|95.0|0.53|1.11||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - Strongly PD-L1 Positive Participants||1.11|0.53|0.07066
91679565|NCT02256436|183251604|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.08745|TWO_SIDED|95.0|0.6|1.1||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - PD-L1 Positive Participants||1.10|0.60|0.08745
91679566|NCT02256436|183251605|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.05328|TWO_SIDED|95.0|0.71|1.04||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - All Participants||1.04|0.71|0.05328
91679567|NCT02256436|183251606|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.5||||9e-05|TWO_SIDED|95.0|10.1|34.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - Strongly PD-L1 Positive Participants||34.2|10.1|0.00009
91679568|NCT02256436|183251607|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.0||||2e-05|TWO_SIDED|95.0|11.1|31.5||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - PD-L1 Positive Participants||31.5|11.1|0.00002
91679569|NCT02256436|183251608|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|13.8||||1e-05|TWO_SIDED|95.0|7.4|20.3||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - All Participants||20.3|7.4|0.00001
91679570|NCT01394952|183251614|SUPERIORITY|"Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis).~Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467."|Hazard Ratio (HR)|0.88||||0.026|TWO_SIDED|95.33|0.79|0.99|||Regression, Cox|||Primary CV endpoint||0.99|0.79|0.026
91679571|NCT01394952|183251615|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.91||||0.211|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||Death from CV causes||1.06|0.78|0.211
91679572|NCT01394952|183251615|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.96||||0.652|TWO_SIDED|95.0|0.79|1.16|||Regression, Cox|||Nonfatal MI||1.16|0.79|0.652
91679573|NCT01394952|183251615|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.76||||0.017|TWO_SIDED|95.0|0.61|0.95|||Regression, Cox|||Nonfatal stroke||0.95|0.61|0.017
91679574|NCT01394952|183251616|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.9||||0.067|TWO_SIDED|95.0|0.8|1.01|||Regression, Cox|||Time to all cause mortality||1.01|0.80|0.067
91487155|NCT04823650|182846758|OTHER||Intraclass correlation coefficient|0.805|||||TWO_SIDED|95.0|0.37|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.94|0.37|
91487156|NCT04823650|182846758|OTHER||Intraclass correlation coefficient|0.953|||||TWO_SIDED|95.0|0.73|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.99|0.73|
91487157|NCT04823650|182846758|OTHER||Intraclass correlation coefficient|0.584|||||TWO_SIDED|95.0|0.06|0.85|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.85|0.06|
91679575|NCT01394952|183251617|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Regression, Cox|||microvascular endpoint||0.93|0.79|<0.001
91679576|NCT01394952|183251618|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.93||||0.456|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox|||Heart failure requiring hospitalization or an urgent heart failure clinic visit||1.12|0.77|0.456
91679577|NCT01394952|183251619|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|1.14||||0.413|TWO_SIDED|95.0|0.84|1.54|||Regression, Cox|||Hospitalization for unstable angina||1.54|0.84|0.413
91679578|NCT01986010|183251627|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.8|2.6||||||GMT Ratio: GMT V160/GMT placebo||2.6|0.8|
91679579|NCT01986010|183251627|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.1|3.2||||||GMT Ratio: GMT V160/GMT placebo||3.2|1.1|
91679580|NCT01986010|183251627|OTHER||GMT Ratio|3.5|||||TWO_SIDED|95.0|1.6|7.4||||||GMT Ratio: GMT V160/GMT placebo||7.4|1.6|
91679581|NCT01986010|183251627|OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.4|4.6||||||GMT Ratio: GMT V160/GMT placebo||4.6|1.4|
91679582|NCT01986010|183251627|OTHER||GMT Ratio|1.6|||||TWO_SIDED|95.0|0.9|3.0||||||GMT Ratio: GMT V160/GMT placebo||3.0|0.9|
91679583|NCT01986010|183251627|OTHER||GMT Ratio|3.9|||||TWO_SIDED|95.0|2.2|7.0||||||GMT Ratio: GMT V160/GMT placebo||7.0|2.2|
91679584|NCT01986010|183251627|OTHER||GMT Ratio|16.4|||<|0.001|TWO_SIDED|95.0|9.5|28.4||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||28.4|9.5|<0.001
91679585|NCT01986010|183251627|OTHER||GMT Ratio|76.6|||<|0.001|TWO_SIDED|95.0|49.5|118.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||118.6|49.5|<0.001
91679586|NCT01986010|183251627|OTHER||GMT Ratio|68.1|||<|0.001|TWO_SIDED|95.0|40.1|115.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||115.6|40.1|<0.001
91679587|NCT01986010|183251627|OTHER||GMT Ratio|41.0|||<|0.001|TWO_SIDED|95.0|23.8|70.7||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||70.7|23.8|<0.001
91679588|NCT01986010|183251627|OTHER||GMT Ratio|128.6|||<|0.001|TWO_SIDED|95.0|87.0|190.3||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||190.3|87.0|<0.001
91679589|NCT01986010|183251627|OTHER||GMT Ratio|62.0|||<|0.001|TWO_SIDED|95.0|30.5|126.1||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||126.1|30.5|<0.001
91679590|NCT01986010|183251627|OTHER||GMT Ratio|63.0|||<|0.001|TWO_SIDED|95.0|31.9|124.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||124.6|31.9|<0.001
91679591|NCT02800213|183251648|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.280
91679592|NCT01948986|183251649|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.07|||||TWO_SIDED|90.0|80.32|132.27|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.27|80.32|
91679593|NCT01948986|183251649|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|156.34|||||TWO_SIDED|90.0|127.83|191.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||191.23|127.83|
91679594|NCT01948986|183251649|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|170.04|||||TWO_SIDED|90.0|139.02|207.98|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||207.98|139.02|
91679595|NCT01948986|183251649|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|155.26|||||TWO_SIDED|90.0|124.38|193.8|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||193.80|124.38|
91679596|NCT01948986|183251650|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.42|||||TWO_SIDED|90.0|80.66|132.61|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.61|80.66|
91679597|NCT01948986|183251650|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|151.63|||||TWO_SIDED|90.0|124.05|185.34|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||185.34|124.05|
91679598|NCT01948986|183251650|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|168.11|||||TWO_SIDED|90.0|137.53|205.49|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||205.49|137.53|
91679599|NCT01948986|183251650|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|151.8|||||TWO_SIDED|90.0|121.69|189.36|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||189.36|121.69|
91679600|NCT01948986|183251652|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|101.57|||||TWO_SIDED|90.0|78.83|130.87|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||130.87|78.83|
91679601|NCT01948986|183251652|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|143.74|||||TWO_SIDED|90.0|117.15|176.37|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||176.37|117.15|
91679602|NCT01948986|183251652|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|140.37|||||TWO_SIDED|90.0|114.4|172.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||172.23|114.40|
91679603|NCT01948986|183251652|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|90.18|||||TWO_SIDED|90.0|71.99|112.96|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||112.96|71.99|
91679604|NCT01948986|183251659|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|80.39|||||TWO_SIDED|90.0|59.41|108.76|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||108.76|59.41|
91679605|NCT01948986|183251659|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|53.46|||||TWO_SIDED|90.0|41.64|68.63|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||68.63|41.64|
91679606|NCT01948986|183251659|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|43.45|||||TWO_SIDED|90.0|33.85|55.78|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||55.78|33.85|
91679607|NCT01948986|183251659|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|29.02|||||TWO_SIDED|90.0|22.04|38.21|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||38.21|22.04|
91679608|NCT01948986|183251676|SUPERIORITY_OR_OTHER||Ratio: Mild Ren. Impa./T2DM Norm. Renal|76.73|||||TWO_SIDED|95.0|48.58|121.19|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||121.19|48.58|
91487158|NCT04823650|182846758|OTHER||Intraclass correlation coefficient|0.785|||||TWO_SIDED|95.0|0.45|0.93|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.93|0.45|
91679609|NCT01948986|183251676|SUPERIORITY_OR_OTHER||Ratio: Mod. Ren. Impa./T2DM Norm. Renal|86.52|||||TWO_SIDED|95.0|54.78|136.65|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||136.65|54.78|
91679610|NCT01948986|183251676|SUPERIORITY_OR_OTHER||Ratio: Sev. Ren. Impa./T2DM Norm. Renal|72.74|||||TWO_SIDED|95.0|44.63|118.58|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||118.58|44.63|
91679611|NCT01948986|183251678|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./T2DM Norm. Ren|49.75|||||TWO_SIDED|90.0|27.22|90.93|||||The model was an ANOVA model with renal function group as a fixed effect.|||90.93|27.22|
91679612|NCT01948986|183251678|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./T2DM Norm. Ren|38.1|||||TWO_SIDED|90.0|20.85|69.64|||||The model was an ANOVA model with renal function group as a fixed effect.|||69.64|20.85|
91679613|NCT01948986|183251678|SUPERIORITY_OR_OTHER||Ratio (Sev. Renal Impair./T2DM Norm. Ren|13.95|||||TWO_SIDED|90.0|7.32|26.58|||||The model was an ANOVA model with renal function group as a fixed effect.|||26.58|7.32|
91679614|NCT00392236|183251679|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||||||0.083
91679615|NCT01898650|183251766|SUPERIORITY|||||||0.004||||||no adjustments for multiple comparisons were made. the threshold for significance was set a priori at 0.05.|t-test, 1 sided|||Null hypothesis was that blood flow would be equivalent on the unaffected and affected sides.||||0.004
91679616|NCT02912650|183251768|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.08|||<|0.001|TWO_SIDED|95.0|24.14|36.02|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||36.02|24.14|<0.001
91679617|NCT02912650|183251768|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.008|TWO_SIDED|95.0|1.51|9.8|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||9.80|1.51|0.008
91679618|NCT02912650|183251768|SUPERIORITY_OR_OTHER||LS Mean Difference|14.76|||<|0.001|TWO_SIDED|95.0|10.55|18.97|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||18.97|10.55|<0.001
91679619|NCT02912650|183251768|SUPERIORITY_OR_OTHER||LS Mean Difference|24.42|||<|0.001|TWO_SIDED|95.0|18.5|30.35|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||30.35|18.50|<0.001
91679620|NCT02912650|183251768|SUPERIORITY_OR_OTHER||LS Mean Difference|15.32|||<|0.001|TWO_SIDED|95.0|9.35|21.29|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||21.29|9.35|<0.001
91679621|NCT02912650|183251768|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1|||<|0.001|TWO_SIDED|95.0|4.9|13.31|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||13.31|4.90|<0.001
91679622|NCT02912650|183251769|SUPERIORITY_OR_OTHER||LS Mean Difference|9.26|||<|0.001|TWO_SIDED|95.0|6.59|11.94|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.94|6.59|<0.001
91679623|NCT02912650|183251769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.84||||0.053|TWO_SIDED|95.0|-0.03|3.71|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.71|-0.03|0.053
91679624|NCT02912650|183251769|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|||<|0.001|TWO_SIDED|95.0|3.69|7.49|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.49|3.69|<0.001
91717667|NCT01004614|183328101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|98.61|||||TWO_SIDED|90.0|93.09|104.46|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||104.46|93.09|
91717668|NCT01004614|183328101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|101.29|||||TWO_SIDED|90.0|97.28|105.45|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||105.45|97.28|
91717669|NCT01004614|183328102|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|99.3|||||TWO_SIDED|90.0|92.28|106.28||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.28|92.28|
91717670|NCT01004614|183328102|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|100.84|||||TWO_SIDED|90.0|95.93|106.0||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.00|95.93|
91717671|NCT02175121|183328124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.33|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|90.0|-51.49|-29.16||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-29.16|-51.49|<0.0001
91717672|NCT02175121|183328124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.53|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|90.0|-57.08|-33.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-33.99|-57.08|<0.0001
91717673|NCT02175121|183328124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.79|STANDARD_ERROR_OF_MEAN|6.73|<|0.0001|TWO_SIDED|90.0|-79.92|-57.65||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-57.65|-79.92|<0.0001
91717674|NCT02175121|183328124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.12|STANDARD_ERROR_OF_MEAN|6.86|<|0.0001|TWO_SIDED|90.0|-79.46|-56.78||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-56.78|-79.46|<0.0001
91717675|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.25|STANDARD_ERROR_OF_MEAN|5.83||0.006|TWO_SIDED|90.0|-25.9|-6.6||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-6.60|-25.90|0.0060
91717676|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.98|STANDARD_ERROR_OF_MEAN|5.94|<|0.0001|TWO_SIDED|90.0|-36.81|-17.15||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-17.15|-36.81|<0.0001
91717677|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.6|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|90.0|-49.2|-30.0||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-30.00|-49.20|<0.0001
91717678|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.72|STANDARD_ERROR_OF_MEAN|5.89|<|0.0001|TWO_SIDED|90.0|-56.46|-36.98||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-36.98|-56.46|<0.0001
91717679|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.07|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-35.89|-18.25||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-18.25|-35.89|<0.0001
91717680|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.18|STANDARD_ERROR_OF_MEAN|5.46|<|0.0001|TWO_SIDED|90.0|-45.21|-27.14||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-27.14|-45.21|<0.0001
91717681|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-51.47|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-60.29|-42.65||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-42.65|-60.29|<0.0001
91717682|NCT02175121|183328125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.17|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|90.0|-66.12|-48.22||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-48.22|-66.12|<0.0001
91717683|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.86|STANDARD_ERROR_OF_MEAN|10.13||0.2063|TWO_SIDED|90.0|-3.91|29.62||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||29.62|-3.91|0.2063
91717684|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.03|STANDARD_ERROR_OF_MEAN|10.33||0.2087|TWO_SIDED|90.0|-4.05|30.11||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||30.11|-4.05|0.2087
91717685|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|10.1||0.5802|TWO_SIDED|90.0|-11.11|22.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||22.30|-11.11|0.5802
91717686|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.64|STANDARD_ERROR_OF_MEAN|10.25||0.1553|TWO_SIDED|90.0|-2.32|31.59||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||31.59|-2.32|0.1553
91717687|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|7.66||0.7741|TWO_SIDED|90.0|-14.87|10.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.47|-14.87|0.7741
91717688|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|7.78||0.9588|TWO_SIDED|90.0|-13.28|12.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||12.47|-13.28|0.9588
91717689|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.42|STANDARD_ERROR_OF_MEAN|7.61||0.8523|TWO_SIDED|90.0|-11.17|14.01||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.01|-11.17|0.8523
91717690|NCT02175121|183328126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|7.73||0.4166|TWO_SIDED|90.0|-6.49|19.08||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.08|-6.49|0.4166
91717691|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.22||0.8516|TWO_SIDED|90.0|-4.73|5.93||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.93|-4.73|0.8516
91717692|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.97|STANDARD_ERROR_OF_MEAN|3.29||0.2303|TWO_SIDED|90.0|-1.48|9.42||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||9.42|-1.48|0.2303
91717693|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|STANDARD_ERROR_OF_MEAN|3.22||0.7132|TWO_SIDED|90.0|-4.15|6.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.52|-4.15|0.7132
91487159|NCT04823650|182846758|OTHER||Intraclass correlation coefficient|0.964|||||TWO_SIDED|95.0|0.63|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.99|0.63|
91487160|NCT04823650|182846759|OTHER||Intraclass correlation coefficient|-0.023|||||TWO_SIDED|95.0|-0.16|0.26|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.26|-0.16|
91717694|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.0034|TWO_SIDED|90.0|4.32|15.16||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||15.16|4.32|0.0034
91487161|NCT04823650|182846759|OTHER||Intraclass correlation coefficient|0.094|||||TWO_SIDED|95.0|-0.21|0.49|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.49|-0.21|
91487162|NCT04823650|182846759|OTHER||Intraclass correlation coefficient|0.45|||||TWO_SIDED|95.0|-0.14|0.8|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.80|-0.14|
91487163|NCT04823650|182846759|OTHER||Intraclass correlation coefficient|-0.014|||||TWO_SIDED|95.0|-0.22|0.35|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.35|-0.22|
91487164|NCT04823650|182846759|OTHER||Intraclass correlation coefficient|-0.13|||||TWO_SIDED|95.0|-0.35|0.26|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.26|-0.35|
91717695|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99|STANDARD_ERROR_OF_MEAN|2.96||0.7394|TWO_SIDED|90.0|-5.89|3.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||3.92|-5.89|0.7394
91717696|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.03||0.8652|TWO_SIDED|90.0|-4.5|5.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.53|-4.50|0.8652
91487165|NCT04823650|182846759|OTHER||Intraclass correlation coefficient|0.284|||||TWO_SIDED|95.0|-0.32|0.71|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.71|-0.32|
91717697|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|2.97||0.837|TWO_SIDED|90.0|-4.3|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-4.30|0.8370
91717698|NCT02175121|183328127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|3.01||0.0018|TWO_SIDED|90.0|4.6|14.58||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.58|4.60|0.0018
91717699|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|4.25||0.6182|TWO_SIDED|90.0|-9.15|4.91||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||4.91|-9.15|0.6182
91487166|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.135|||||TWO_SIDED|95.0|-0.16|0.53|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs APDM||0.53|-0.16|
91487167|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.197|||||TWO_SIDED|95.0|-0.114|0.64|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs APDM||0.64|-0.114|
91487168|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.341|||||TWO_SIDED|95.0|-0.17|0.73|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs APDM||0.73|-0.17|
91487169|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.38|||||TWO_SIDED|95.0|-0.23|0.76|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.76|-0.23|
91487170|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.371|||||TWO_SIDED|95.0|-0.12|0.74|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.74|-0.12|
91717700|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|4.34||0.7028|TWO_SIDED|90.0|-5.52|8.84||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.84|-5.52|0.7028
91717701|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|4.25||0.9445|TWO_SIDED|90.0|-7.33|6.73||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.73|-7.33|0.9445
91717702|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.07|STANDARD_ERROR_OF_MEAN|4.32||0.0373|TWO_SIDED|90.0|1.93|16.21||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.21|1.93|0.0373
91717703|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|4.21||0.9448|TWO_SIDED|90.0|-7.25|6.67||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.67|-7.25|0.9448
91717704|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|4.3||0.9312|TWO_SIDED|90.0|-6.74|7.49||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.49|-6.74|0.9312
91717705|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|4.21||0.9791|TWO_SIDED|90.0|-7.07|6.85||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.85|-7.07|0.9791
91717706|NCT02175121|183328128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.34|STANDARD_ERROR_OF_MEAN|4.28||0.0044|TWO_SIDED|90.0|5.26|19.41||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.41|5.26|0.0044
91717707|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|3.96||0.6553|TWO_SIDED|90.0|-4.78|8.33||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.33|-4.78|0.6553
91717708|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.61|STANDARD_ERROR_OF_MEAN|4.05||0.2569|TWO_SIDED|90.0|-2.09|11.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||11.30|-2.09|0.2569
91717709|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64|STANDARD_ERROR_OF_MEAN|3.96||0.0553|TWO_SIDED|90.0|1.09|14.18||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||14.18|1.09|0.0553
91717710|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.89|STANDARD_ERROR_OF_MEAN|4.01||0.0016|TWO_SIDED|90.0|6.26|19.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||19.53|6.26|0.0016
91717711|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|3.58||0.8717|TWO_SIDED|90.0|-5.35|6.51||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.51|-5.35|0.8717
91717712|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|3.66||0.743|TWO_SIDED|90.0|-4.86|7.26||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.26|-4.86|0.7430
91717713|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.58||0.2041|TWO_SIDED|90.0|-1.36|10.48||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.48|-1.36|0.2041
91717714|NCT02175121|183328129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.92|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|90.0|8.92|20.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||20.92|8.92|<0.0001
91717715|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|4.08||0.975|TWO_SIDED|90.0|-6.62|6.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.87|-6.62|0.9750
91717716|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.99|STANDARD_ERROR_OF_MEAN|4.16||0.3396|TWO_SIDED|90.0|-2.9|10.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||10.87|-2.90|0.3396
91717717|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|4.07||0.7142|TWO_SIDED|90.0|-8.23|5.24||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.24|-8.23|0.7142
91487171|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.364|||||TWO_SIDED|95.0|-0.15|0.74|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.74|-0.15|
91487172|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.234|||||TWO_SIDED|95.0|-0.18|0.65|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar||0.65|-0.18|
91717718|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.78|STANDARD_ERROR_OF_MEAN|4.14||0.0192|TWO_SIDED|90.0|2.94|16.63||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.63|2.94|0.0192
91487173|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.493|||||TWO_SIDED|95.0|-0.17|0.87|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar||0.87|-0.17|
91487174|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.333|||||TWO_SIDED|95.0|-0.2|0.75|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar||0.75|-0.20|
91717719|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|3.85||0.8277|TWO_SIDED|90.0|-7.2|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-7.20|0.8277
91717720|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|3.93||0.8857|TWO_SIDED|90.0|-5.93|7.06||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.06|-5.93|0.8857
91717721|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|3.84||0.8824|TWO_SIDED|90.0|-6.93|5.79||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.79|-6.93|0.8824
91717722|NCT02175121|183328130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.23|STANDARD_ERROR_OF_MEAN|3.9||0.0192|TWO_SIDED|90.0|2.77|15.69||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||15.69|2.77|0.0192
91717723|NCT00931632|183328156|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Mantel Haenszel|||||||0.427
91717724|NCT01419314|183328165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.19|STANDARD_DEVIATION|20.25||0.001|TWO_SIDED|95.0|38.33|52.05|||ANOVA|Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).||A repeated measure ANOVA was performed to evaluate the contrasts of interest.||52.05|38.33|0.001
91717725|NCT01419314|183328165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.09|STANDARD_ERROR_OF_MEAN|3.6|<|0.0005|TWO_SIDED|95.0|8.8|23.39||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided||Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.|Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?||23.39|8.80|<0.0005
91717726|NCT01419314|183328165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|5.27||0.155|TWO_SIDED|95.0|-13.93|7.47||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided|df(35)|The statistical power for the between intervention contrast was calculated to be 0.26|Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.||7.47|-13.93|0.155
91717727|NCT01419314|183328165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|STANDARD_ERROR_OF_MEAN|6.66||0.155|TWO_SIDED|95.0|-23.2|3.85|||t-test, 2 sided|df(35)||Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.||3.85|-23.20|0.155
91717728|NCT00843492|183328178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.15|0.54|||Fisher Exact|||||0.54|0.15|<0.001
91717729|NCT00457730|183328203|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
91717730|NCT00457730|183328204|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
91487175|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.228|||||TWO_SIDED|95.0|-0.06|0.59|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM||0.59|-0.06|
91717731|NCT00457730|183328205|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
91717732|NCT00721799|183328206|OTHER||Hazard Ratio (HR)|0.47||||0.08|TWO_SIDED||||||Regression, Cox|||||||0.08
91717733|NCT00721799|183328206|OTHER||C-statistic|0.73||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
91717734|NCT00721799|183328207|OTHER||Hazard Ratio (HR)|0.42||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
91717735|NCT00721799|183328207|OTHER||C-statistic|0.75||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
91717736|NCT00721799|183328208|OTHER||Hazard Ratio (HR)|2.44|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
91717737|NCT00721799|183328208|OTHER||C-statistic|0.74||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
91717738|NCT00721799|183328209|OTHER||Hazard Ratio (HR)|1.12||||0.73|TWO_SIDED||||||Regression, Cox|||||||0.73
91717739|NCT00721799|183328209|OTHER||C-statistic|0.52||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
91717740|NCT00721799|183328210|OTHER||Hazard Ratio (HR)|1.11||||0.78|TWO_SIDED||||||Regression, Cox|||||||0.78
91717741|NCT00721799|183328210|OTHER||C-statistic|0.45||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
91717742|NCT00721799|183328211|OTHER||Hazard Ratio (HR)|2.25||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
91717743|NCT00721799|183328211|OTHER||C-statistic|0.7||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
91717744|NCT00721799|183328212|OTHER||Hazard Ratio (HR)|0.83||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
91717745|NCT00721799|183328212|OTHER||C-statistic|0.58||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
91717746|NCT00721799|183328213|OTHER||Hazard Ratio (HR)|0.81||||0.58|TWO_SIDED||||||Regression, Cox|||||||0.58
91717747|NCT00721799|183328213|OTHER||C-statistic|0.6||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
91717748|NCT00721799|183328214|OTHER||Hazard Ratio (HR)|0.94||||0.89|TWO_SIDED||||||Regression, Cox|||||||0.89
91717749|NCT00721799|183328214|OTHER||C-statistic|0.59||||0.42|TWO_SIDED||||||Regression, Cox|||||||0.42
91717750|NCT00721799|183328215|OTHER||Hazard Ratio (HR)|1.29||||0.43|TWO_SIDED||||||Regression, Cox|||||||0.43
91717751|NCT00721799|183328215|OTHER||C-statistic|0.47||||0.8|TWO_SIDED||||||Regression, Cox|||||||0.80
91717752|NCT00721799|183328216|OTHER||Hazard Ratio (HR)|2.01||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
91717753|NCT00721799|183328216|OTHER||C-statistic|0.69||||0.07|TWO_SIDED||||||Regression, Cox|||||||0.07
91717754|NCT00721799|183328217|OTHER||Hazard Ratio (HR)|1.58||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
91717755|NCT00721799|183328217|OTHER||C-statistic|0.63||||0.25|TWO_SIDED||||||Regression, Cox|||||||0.25
91717756|NCT00721799|183328218|OTHER||Hazard Ratio (HR)|1.49||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
91717757|NCT00721799|183328218|OTHER||C-statistic|0.62||||0.27|TWO_SIDED||||||Regression, Cox|||||||0.27
91717758|NCT00721799|183328219|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED||||||Regression, Cox|||||||0.99
91717759|NCT00721799|183328219|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
91717760|NCT00721799|183328220|OTHER||Hazard Ratio (HR)|1.3||||0.41|TWO_SIDED||||||Regression, Cox|||||||0.41
91717761|NCT00721799|183328220|OTHER||C-statistic|0.54||||0.69|TWO_SIDED||||||Regression, Cox|||||||0.69
91717762|NCT00721799|183328221|OTHER||Hazard Ratio (HR)|1.56||||0.17|TWO_SIDED||||||Regression, Cox|||||||0.17
91717763|NCT00721799|183328221|OTHER||C-statistic|0.64||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
91717764|NCT00721799|183328222|OTHER||Hazard Ratio (HR)|0.42||||0.09|TWO_SIDED||||||Regression, Cox|||||||0.09
91717765|NCT00721799|183328222|OTHER||Hazard Ratio (HR)|0.72||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
91717766|NCT00721799|183328223|OTHER||Hazard Ratio (HR)|0.36||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
91487176|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.335|||||TWO_SIDED|95.0|-0.1|0.74|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM||0.74|-0.10|
91717767|NCT00721799|183328223|OTHER||C-statistic|0.74||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
91717768|NCT00721799|183328224|OTHER||Hazard Ratio (HR)|3.01|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
91717769|NCT00721799|183328224|OTHER||C-statistic|0.82|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
91717770|NCT00721799|183328225|OTHER||Hazard Ratio (HR)|1.03||||0.92|TWO_SIDED||||||Regression, Cox|||||||0.92
91717771|NCT00721799|183328225|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
91717772|NCT00721799|183328226|OTHER||Hazard Ratio (HR)|1.11||||0.76|TWO_SIDED||||||Regression, Cox|||||||0.76
91717773|NCT00721799|183328226|OTHER||C-statistic|0.45||||0.68|TWO_SIDED||||||Regression, Cox|||||||0.68
91717774|NCT00721799|183328227|OTHER||Hazard Ratio (HR)|2.99|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
91717775|NCT00721799|183328227|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
91717776|NCT00721799|183328228|OTHER||Hazard Ratio (HR)|0.78||||0.55|TWO_SIDED||||||Regression, Cox|||||||0.55
91717777|NCT00721799|183328228|OTHER||C-statistic|0.61||||0.35|TWO_SIDED||||||Regression, Cox|||||||0.35
91717778|NCT00721799|183328229|OTHER||Hazard Ratio (HR)|0.74||||0.48|TWO_SIDED||||||Regression, Cox|||||||0.48
91717779|NCT00721799|183328229|OTHER||C-statistic|0.63||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
91717780|NCT00721799|183328230|OTHER||Hazard Ratio (HR)|0.81||||0.67|TWO_SIDED||||||Regression, Cox|||||||0.67
91717781|NCT00721799|183328230|OTHER||C-statistic|0.71||||0.11|TWO_SIDED||||||Regression, Cox|||||||0.11
91717782|NCT00721799|183328231|OTHER||Hazard Ratio (HR)|1.32||||0.4|TWO_SIDED||||||Regression, Cox|||||||0.40
91717783|NCT00721799|183328231|OTHER||C-statistic|0.48||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
91717784|NCT00721799|183328232|OTHER||Hazard Ratio (HR)|2.39|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
91717785|NCT00721799|183328232|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
91717786|NCT00721799|183328233|OTHER||Hazard Ratio (HR)|1.51||||0.26|TWO_SIDED||||||Regression, Cox|||||||0.26
91717787|NCT00721799|183328233|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
91717788|NCT00721799|183328234|OTHER||Hazard Ratio (HR)|1.38||||0.37|TWO_SIDED||||||Regression, Cox|||||||0.37
91717789|NCT00721799|183328234|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
91717790|NCT00721799|183328235|OTHER||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED||||||Regression, Cox|||||||0.90
91717791|NCT00721799|183328235|OTHER||C-statistic|0.52||||0.87|TWO_SIDED||||||Regression, Cox|||||||0.87
91717792|NCT00721799|183328236|OTHER||Hazard Ratio (HR)|1.35||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
91717793|NCT00721799|183328236|OTHER||C-statistic|0.56||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
91717794|NCT00721799|183328237|OTHER||Hazard Ratio (HR)|1.56||||0.2|TWO_SIDED||||||Regression, Cox|||||||0.20
91717795|NCT00721799|183328237|OTHER||C-statistic|0.63||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
91717796|NCT01926028|183328245|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.39||||0.03|TWO_SIDED|95.0|0.17|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|0.17|0.03
91717797|NCT01926028|183328246|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.55||||0.1|TWO_SIDED|95.0|0.27|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.27|0.10
91717798|NCT04539275|183328255|SUPERIORITY||Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.15|0.14|||Fisher Exact|||||0.14|-0.15|1.00
91717799|NCT04539275|183328256|SUPERIORITY||Improvement Rate Ratio|1.08||||0.749|TWO_SIDED|95.0|0.65|1.78|||Log Rank|||||1.78|0.65|0.749
91717800|NCT04539275|183328257|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.943|TWO_SIDED|95.0|0.21|4.23|||Log Rank|||||4.23|0.21|0.943
91717801|NCT04539275|183328258|SUPERIORITY||Risk Difference (RD)|-0.08||||0.4014|TWO_SIDED|95.0|-0.25|0.1|||Chi-squared|||||0.10|-0.25|0.4014
91717802|NCT04539275|183328259|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.3762|TWO_SIDED|95.0|0.18|1.96|||Log Rank|||||1.96|0.18|0.3762
91717803|NCT04539275|183328260|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6867|TWO_SIDED|95.0|-0.17|0.09|||Fisher Exact|||||0.09|-0.17|0.6867
91717804|NCT04539275|183328261|SUPERIORITY||Improvement Rate Ratio|1.11||||0.6494|TWO_SIDED|95.0|0.68|1.83|||Log Rank|||||1.83|0.68|0.6494
91717805|NCT04539275|183328262|SUPERIORITY||Improvement Rate Ratio|0.98||||0.9338|TWO_SIDED|95.0|0.59|1.63|||Log Rank|||||1.63|0.59|0.9338
91717806|NCT04539275|183328266|SUPERIORITY||Improvement Rate Ratio|1.14||||0.5682|TWO_SIDED|95.0|0.7|1.86|||Log Rank|||||1.86|0.70|0.5682
91717807|NCT04539275|183328268|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8642|TWO_SIDED|95.0|-2.3|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|-2.3|0.8642
91717808|NCT01799941|183328270|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
91717809|NCT01799941|183328270|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||one-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
91717810|NCT01799941|183328270|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
91717811|NCT01799941|183328270|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
91717812|NCT01799941|183328270|SUPERIORITY_OR_OTHER||Analysis of covariance (ANCOVA)|0.04|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-1.37|1.45|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||1.45|-1.37|
91717813|NCT01799941|183328270|SUPERIORITY_OR_OTHER||ANCOVA|1.11|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.46|2.68|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.68|-0.46|
91717814|NCT01799941|183328270|SUPERIORITY_OR_OTHER||ANCOVA|1.15|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.39|2.69|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.69|-0.39|
91717815|NCT01799941|183328271|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717816|NCT01799941|183328271|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717817|NCT01799941|183328271|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717818|NCT01799941|183328271|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717819|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
91717820|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
91717821|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
91717822|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 assessment||||<0.0001
91717823|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
91717824|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
91717825|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
91717826|NCT01799941|183328272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
91717827|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.425|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.407|0.445|||Mixed Effects Poisson Regreesion Model||Number of observations = 854, Number of participants = 298|Day 30 assessment||0.445|0.407|<0.0001
91717828|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.277|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.262|0.293|||Mixed Effects Poisson Regression Model||Number of observations = 854, Number of participants = 298|Day 90 assessment||0.293|0.262|<0.0001
91717829|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.5|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.469|0.534|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 30 assessment||0.534|0.469|<0.0001
91717830|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.299|0.349|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 90 assessment||0.349|0.299|<0.0001
91717831|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.351|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.323|0.383|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 30 assessment||0.383|0.323|<0.0001
91717832|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.255|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.231|0.282|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 90 assessment||0.282|0.231|<0.0001
91717833|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.387|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|0.352|0.425|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 30 assessment||0.425|0.352|<0.0001
91717834|NCT01799941|183328274|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.215|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.189|0.245|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 90 assessment||0.245|0.189|<0.0001
91717835|NCT01799941|183328277|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717836|NCT01799941|183328277|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717837|NCT01799941|183328277|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717838|NCT01799941|183328277|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
91717839|NCT01569022|183328319|EQUIVALENCE|The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91717840|NCT01569022|183328320|EQUIVALENCE|t test assuming unequal variance||||||0.97|||||||t-test, 2 sided|||ESS||||0.97
91717841|NCT01569022|183328320|EQUIVALENCE|t test assuming unequal variance||||||0.98|||||||t-test, 2 sided|||PCL||||0.98
91717842|NCT01569022|183328320|EQUIVALENCE|t-test assuming non unequal variance||||||0.31|||||||t-test, 2 sided|||PSQI||||0.31
91717843|NCT01569022|183328321|EQUIVALENCE|t test assuming unequal variance||||||0.54|||||||t-test, 2 sided|||||||0.54
91717844|NCT01569022|183328322|EQUIVALENCE|t test assuming unequal variance|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91717845|NCT00644059|183328325|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|97.66|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
91717846|NCT00644059|183328328|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|95.0|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
91717847|NCT00644059|183328328|SUPERIORITY_OR_OTHER||Vaccine Efficacy|95.5|||||TWO_SIDED|95.0|80.92|98.94|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||98.94|80.92|
91717848|NCT00644059|183328328|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.32|||||TWO_SIDED|95.0|0.13|0.73|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.73|0.13|
91717849|NCT00644059|183328328|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.09|||||TWO_SIDED|95.0|0.02|0.38|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.38|0.02|
91717850|NCT00644059|183328329|SUPERIORITY_OR_OTHER||vaccine Efficacy|79.18|||||TWO_SIDED|95.0|54.78|90.42|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||90.42|54.78|
91717851|NCT00644059|183328329|SUPERIORITY_OR_OTHER||Vaccine Efficacy|92.1|||||TWO_SIDED|95.0|77.35|97.24|||Poisson Regression Model|||Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)||97.24|77.35|
91487177|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.343|||||TWO_SIDED|95.0|-0.03|0.7|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Wrist vs ActiGraph Lumbar vs APDM||0.70|-0.03|
91717852|NCT00644059|183328329|SUPERIORITY_OR_OTHER||Vaccine Efficacy|64.16|||||TWO_SIDED|95.0|23.21|83.28|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||83.28|23.21|
91717853|NCT00644059|183328329|SUPERIORITY_OR_OTHER||Vaccine Efficacy|85.66|||||TWO_SIDED|95.0|58.95|94.99|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||94.99|58.95|
91717854|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|0.83|||||TWO_SIDED|95.0|0.67|1.02|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.02|0.67|
91717855|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|7.63|||||TWO_SIDED|95.0|5.42|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.42|
91717856|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|15.0|||||TWO_SIDED|95.0|11.0|21.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||21|11|
91487178|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.376|||||TWO_SIDED|95.0|-0.2|0.77|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs APDM||0.77|-0.20|
91717857|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|6.48|||||TWO_SIDED|95.0|4.83|8.68|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||8.68|4.83|
91717858|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.21|0.85|
91487179|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.15|||||TWO_SIDED|95.0|-0.12|0.56|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs APDM||0.56|-0.12|
91487180|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.315|||||TWO_SIDED|95.0|-0.18|0.71|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs APDM||0.71|-0.18|
91487181|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.449|||||TWO_SIDED|95.0|-0.14|0.8|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.80|-0.14|
91487182|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.241|||||TWO_SIDED|95.0|-0.22|0.65|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.65|-0.22|
91487183|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.399|||||TWO_SIDED|95.0|-0.14|0.77|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.77|-0.14|
91487184|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.507|||||TWO_SIDED|95.0|-0.22|0.86|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar||0.86|-0.22|
91487185|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.299|||||TWO_SIDED|95.0|-0.18|0.72|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar||0.72|-0.18|
91679625|NCT02912650|183251769|SUPERIORITY_OR_OTHER||LS Mean Difference|7.42|||<|0.001|TWO_SIDED|95.0|4.75|10.09|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.09|4.75|<0.001
91487186|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.3|||||TWO_SIDED|95.0|-0.17|0.74|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar||0.74|-0.17|
91487187|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.444|||||TWO_SIDED|95.0|-0.02|0.78|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar vs APDM||0.78|-0.02|
91526789|NCT03029247|182929108|SUPERIORITY||LS Mean Difference|-2.4||||0.4611|TWO_SIDED|95.0|-8.88|4.07||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||4.07|-8.88|0.4611
91679626|NCT02912650|183251769|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67||||0.008|TWO_SIDED|95.0|0.98|6.36|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.36|0.98|0.008
91679627|NCT02912650|183251769|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.85|5.64|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|1.85|<0.001
91679628|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|13.05|||<|0.001|TWO_SIDED|95.0|10.39|15.71|||ANOVA|||0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.||15.71|10.39|<0.001
91679629|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|3.01||||0.002|TWO_SIDED|95.0|1.15|4.86|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.86|1.15|0.002
91679630|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|6.94|||<|0.001|TWO_SIDED|95.0|5.06|8.83|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.83|5.06|<0.001
91679631|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|10.05|||<|0.001|TWO_SIDED|95.0|7.39|12.7|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.70|7.39|<0.001
91679632|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|6.11|||<|0.001|TWO_SIDED|95.0|3.44|8.78|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.78|3.44|<0.001
91679633|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|3.94|||<|0.001|TWO_SIDED|95.0|2.06|5.81|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.81|2.06|<0.001
91679634|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|3.84|||<|0.001|TWO_SIDED|95.0|2.63|5.05|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.05|2.63|<0.001
91679635|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.013|TWO_SIDED|95.0|0.23|1.92|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.23|0.013
91679636|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|1.83|3.55|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.55|1.83|<0.001
91526790|NCT03029247|182929109|SUPERIORITY||LS Mean Difference|-2.95||||0.1648|TWO_SIDED|95.0|-7.14|1.24||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||1.24|-7.14|0.1648
91717859|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|9.82|||||TWO_SIDED|95.0|7.76|12.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||12|7.76|
91717860|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|16.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||20|12|
91717861|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|4.92|||||TWO_SIDED|95.0|3.64|6.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||6.65|3.64|
91717862|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.0|||||TWO_SIDED|95.0|0.91|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.91|
91717863|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.5|||||TWO_SIDED|95.0|1.19|1.9|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.9|1.19|
91717864|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|6.99|||||TWO_SIDED|95.0|5.72|8.53|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||8.53|5.72|
91717865|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|2.92|||||TWO_SIDED|95.0|2.44|3.5|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||3.5|2.44|
91717866|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.81|||||TWO_SIDED|95.0|0.64|1.04|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.04|0.64|
91717867|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|1.21|||||TWO_SIDED|95.0|0.83|1.78|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.78|0.83|
91679637|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.56|3.98|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.98|1.56|<0.001
91717868|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1]|7.54|||||TWO_SIDED|95.0|5.33|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.33|
91717869|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|3.31|||||TWO_SIDED|95.0|2.4|4.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.55|2.4|
91717870|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.74|
91717871|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT[A/Wisconsin/2009 (A/H3N2)]|3.54|||||TWO_SIDED|95.0|2.78|4.51|||GMT|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.51|2.78|
91717872|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|13.0|||||TWO_SIDED|95.0|10.0|16.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||16|10|
91717873|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.6|||||TWO_SIDED|95.0|2.61|4.95|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.95|2.61|
91717874|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|1.0|1.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1|1|
91527573|NCT01976364|182930469|OTHER||LS Mean Difference|0.032|||||TWO_SIDED|95.0|-0.163|0.227||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.227|-0.163|
91679638|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.064|TWO_SIDED|95.0|-0.07|2.37|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.37|-0.07|0.064
91679639|NCT02912650|183251770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|0.76|2.47|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|0.76|<0.001
91679640|NCT02912650|183251771|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679641|NCT02912650|183251771|SUPERIORITY_OR_OTHER|||||||0.069|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.069
91679642|NCT02912650|183251771|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91717875|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.06|||||TWO_SIDED|95.0|1.02|1.11|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.11|1.02|
91717876|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.74|||||TWO_SIDED|95.0|1.57|1.92|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.92|1.57|
91717877|NCT00644059|183328335|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.08|0.92|
91717878|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.78|1.19|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.19|0.78|
91679643|NCT02912650|183251771|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679644|NCT02912650|183251771|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679645|NCT02912650|183251771|SUPERIORITY_OR_OTHER|||||||0.005|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.005
91679646|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
91679647|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
91679648|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||ANOVA|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
91717879|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|6.41|||||TWO_SIDED|95.0|4.69|8.76|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.76|4.69|
91717880|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|8.26|||||TWO_SIDED|95.0|6.36|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||11|6.36|
91717881|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|4.37|||||TWO_SIDED|95.0|3.38|5.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.65|3.38|
91717882|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \<72 months by HI assay.||1.35|0.82|
91717883|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|6.42|||||TWO_SIDED|95.0|4.72|8.73|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.73|4.72|
91679649|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
91679650|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
91679651|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
91679652|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
91679653|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
91679654|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
91679655|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
91487188|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.217|||||TWO_SIDED|95.0|-0.08|0.59|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs Actigraph Lumbar vs APDM||0.59|-0.08|
91487189|NCT04823650|182846760|OTHER||Intraclass correlation coefficient|0.321|||||TWO_SIDED|95.0|-0.07|0.7|||||Agreement between devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Wrist vs ActiGraph Lumbar vs APDM||0.70|-0.07|
91487190|NCT04823650|182846761|OTHER||Intraclass correlation coefficient|0.323|||||TWO_SIDED|95.0|-0.28|0.73|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.73|-0.28|
91526791|NCT03029247|182929110|SUPERIORITY||LS Mean Difference|-13.42||||0.9142|TWO_SIDED|95.0|-261.75|234.92||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||234.92|-261.75|0.9142
91526792|NCT03029247|182929110|SUPERIORITY||LS Mean Difference|-71.7||||0.2266|TWO_SIDED|95.0|-189.21|45.8||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||45.80|-189.21|0.2266
91679656|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
91679657|NCT02912650|183251772|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
91679658|NCT02912650|183251773|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679659|NCT02912650|183251773|SUPERIORITY_OR_OTHER|||||||0.003|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.003
91679660|NCT02912650|183251773|SUPERIORITY_OR_OTHER|||||||0.031|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.031
91679661|NCT02912650|183251773|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91487191|NCT04823650|182846761|OTHER||Intraclass correlation coefficient|0.822|||||TWO_SIDED|95.0|0.23|0.95|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.95|0.23|
91679662|NCT02912650|183251773|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679663|NCT02912650|183251773|SUPERIORITY_OR_OTHER|||||||0.631|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.631
91487192|NCT04823650|182846761|OTHER||Intraclass correlation coefficient|0.973|||||TWO_SIDED|95.0|0.91|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 1: ActiGraph Lumbar vs APDM||0.99|0.91|
91487193|NCT04823650|182846761|OTHER||Intraclass correlation coefficient|0.644|||||TWO_SIDED|95.0|0.16|0.88|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.88|0.16|
91679664|NCT02912650|183251774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679665|NCT02912650|183251774|SUPERIORITY_OR_OTHER|||||||0.088|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.088
91679666|NCT02912650|183251774|SUPERIORITY_OR_OTHER|||||||0.133|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.133
91679667|NCT02912650|183251774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679668|NCT02912650|183251774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
91679669|NCT02912650|183251774|SUPERIORITY_OR_OTHER|||||||0.887|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.887
91679670|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.14|<0.001
91679671|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.034|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.034
91679672|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.963|TWO_SIDED|95.0|-0.13|0.14|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.13|0.963
91679673|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.062|TWO_SIDED|95.0|-0.01|0.37|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.01|0.062
91717884|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|7.98|||||TWO_SIDED|95.0|6.2|10.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||10|6.2|
91717885|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|3.13|||||TWO_SIDED|95.0|2.42|4.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.05|2.42|
91717886|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.05|0.9|
91717887|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|1.56|||||TWO_SIDED|95.0|1.26|1.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.93|1.26|
91717888|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|5.0|||||TWO_SIDED|95.0|4.25|5.88|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.88|4.25|
91717889|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|2.55|||||TWO_SIDED|95.0|2.22|2.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.93|2.22|
91717890|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.75|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|0.75|
91717891|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|1.72|||||TWO_SIDED|95.0|1.17|2.51|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.51|1.17|
91717892|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|5.58|||||TWO_SIDED|95.0|4.08|7.63|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||7.63|4.08|
91717893|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|3.11|||||TWO_SIDED|95.0|2.3|4.2|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.2|2.3|
91717894|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.98|||||TWO_SIDED|95.0|0.74|1.3|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.3|0.74|
91717895|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.14|||||TWO_SIDED|95.0|2.19|4.49|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.49|2.19|
91717896|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|7.36|||||TWO_SIDED|95.0|5.51|9.82|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||9.82|5.51|
91717897|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|2.66|||||TWO_SIDED|95.0|2.0|3.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||3.55|2|
91526793|NCT03029247|182929110|SUPERIORITY||LS Mean Difference|-54.24||||0.5246|TWO_SIDED|95.0|-223.99|115.51||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||115.51|-223.99|0.5246
91717898|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.01|0.98|
91717899|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.13|||||TWO_SIDED|95.0|1.05|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|1.05|
91717900|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.79|||||TWO_SIDED|95.0|1.63|1.97|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.97|1.63|
91717901|NCT00644059|183328338|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.08|||||TWO_SIDED|95.0|1.0|1.17|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.17|1|
91717902|NCT02497469|183328363|SUPERIORITY||Adjusted Difference|8.8||||0.0061|TWO_SIDED|95.0|2.5|15.0|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|15.0|2.5|0.0061
91717903|NCT02497469|183328364|SUPERIORITY||Adjusted Difference|11.9||||0.0005|TWO_SIDED|95.0|5.3|18.5|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|18.5|5.3|0.0005
91717904|NCT02497469|183328365|SUPERIORITY||Adjusted Difference|-9.3||||0.0641|TWO_SIDED|95.0|-18.9|0.4|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|0.4|-18.9|0.0641
91717905|NCT03558516|183328366|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||||||0.315
91487194|NCT04823650|182846761|OTHER||Intraclass correlation coefficient|0.829|||||TWO_SIDED|95.0|0.55|0.94|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.94|0.55|
91526794|NCT03029247|182929111|SUPERIORITY||LS Mean Difference|-74.4||||0.1563|TWO_SIDED|95.0|-178.15|29.34||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||29.34|-178.15|0.1563
91679674|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.001|TWO_SIDED|95.0|0.13|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.13|0.001
91679675|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.04|TWO_SIDED|95.0|-0.28|-0.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.01|-0.28|0.040
91487195|NCT04823650|182846761|OTHER||Intraclass correlation coefficient|0.98|||||TWO_SIDED|95.0|0.93|0.99|||||Agreement between two devices' measurements was assessed by the intraclass correlation coefficient as: \<= 0.4 (poor), 0.4 to 0.59 (moderate), 0.6 to 0.74 (good), and 0.75 to 1 (excellent) agreement.|Activity Block 2: ActiGraph Lumbar vs APDM||0.99|0.93|
91679676|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
91679677|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.095|TWO_SIDED|95.0|-0.03|0.37|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.03|0.095
91679678|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.414|TWO_SIDED|95.0|-0.12|0.29|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.29|-0.12|0.414
91679679|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81|||<|0.001|TWO_SIDED|95.0|0.52|1.1|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.52|<0.001
91679680|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.61|1.19|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.61|<0.001
91487196|NCT06350474|182846808|NON_INFERIORITY|The non-inferiority margin is -3.|Mean Difference (Final Values)|0.346|||<|0.0001|TWO_SIDED|95.0|-0.5|1.1||One-sided test for non-inferiority.|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||1.1|-0.5|<0.0001
91487197|NCT06350474|182846809|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.414|TWO_SIDED|95.0|-0.4|0.2|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.2|-0.4|0.414
91526795|NCT03029247|182929112|SUPERIORITY||LS Mean Difference|-2.06||||0.3247|TWO_SIDED|95.0|-6.23|2.1||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||2.10|-6.23|0.3247
91526796|NCT03029247|182929112|SUPERIORITY||LS Mean Difference|-2.51||||0.4235|TWO_SIDED|95.0|-8.76|3.74||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||3.74|-8.76|0.4235
91679681|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.29|0.406
91679682|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.4|2.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.09|1.40|<0.001
91679683|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.006|TWO_SIDED|95.0|0.1|0.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.10|0.006
91679684|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33||||0.009|TWO_SIDED|95.0|0.08|0.57|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.57|0.08|0.009
91679685|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|1.07|1.75|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|1.07|<0.001
91679686|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.08|1.77|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.77|1.08|<0.001
91679687|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.908|TWO_SIDED|95.0|-0.26|0.23|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.23|-0.26|0.908
91679688|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.99|||<|0.001|TWO_SIDED|95.0|1.64|2.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.35|1.64|<0.001
91679689|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.002|TWO_SIDED|95.0|0.15|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.15|0.002
91679690|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.32|0.82|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.82|0.32|<0.001
91679691|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.25|1.95|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|1.25|<0.001
91487198|NCT06350474|182846810|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.241|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||2.9|-1.0|0.241
91487199|NCT06350474|182846811|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.233|TWO_SIDED|95.0|-2.5|0.6|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.6|-2.5|0.233
91487200|NCT06350474|182846812|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.42|TWO_SIDED|95.0|-0.4|0.97|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.97|-0.4|0.42
91487201|NCT06350474|182846813|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.69|TWO_SIDED|95.0|-0.92|0.61|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.61|-0.92|0.69
91679692|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.07|1.78|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.78|1.07|<0.001
91679693|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.157|TWO_SIDED|95.0|-0.07|0.43|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.07|0.157
91679694|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.73|2.48|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.48|1.73|<0.001
91679695|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.005|TWO_SIDED|95.0|0.11|0.63|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|0.11|0.005
91679696|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.52|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.52|<0.001
91679697|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.1|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.10|1.36|<0.001
91679698|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.94|<0.001
91679699|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.002|TWO_SIDED|95.0|0.15|0.68|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.15|0.002
91679700|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|2.06|||<|0.001|TWO_SIDED|95.0|1.67|2.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.45|1.67|<0.001
91679701|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.004|TWO_SIDED|95.0|0.13|0.67|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.13|0.004
91679702|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.37|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.82|<0.001
91679703|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.27|2.04|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.04|1.27|<0.001
91679704|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|||<|0.001|TWO_SIDED|95.0|0.58|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.58|<0.001
91679705|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.42|0.96|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.96|0.42|<0.001
91679706|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.001|TWO_SIDED|95.0|1.6|2.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.40|1.60|<0.001
91679707|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.72|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|0.16|0.002
91679708|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.88|1.44|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.88|<0.001
91679709|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.96|1.16|<0.001
91679710|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.44|1.24|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.44|<0.001
91679711|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.44|1.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.44|<0.001
91679712|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.5|2.31|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.50|<0.001
91679713|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.74|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.74|0.18|0.001
91679714|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.85|1.43|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.85|<0.001
91679715|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|1.04|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.85|1.04|<0.001
91487202|NCT06350474|182846814|SUPERIORITY||Difference in % Participants|2.5||||0.275|TWO_SIDED|95.0|-1.5|6.5|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||6.5|-1.5|0.275
91679716|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.77|||<|0.001|TWO_SIDED|95.0|0.36|1.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.17|0.36|<0.001
91679717|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.39|0.97|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|0.39|<0.001
91679718|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|1.13|1.98|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.98|1.13|<0.001
91679719|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.017
91679720|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|||<|0.001|TWO_SIDED|95.0|0.77|1.37|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.77|<0.001
91679721|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.78|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.78|<0.001
91679722|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.026|TWO_SIDED|95.0|0.06|0.91|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.06|0.026
91679723|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.01|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.01|0.42|<0.001
91679724|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|||<|0.001|TWO_SIDED|95.0|0.84|1.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.84|<0.001
91679725|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.017
91679726|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.6|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.60|<0.001
91487203|NCT06350474|182846816|SUPERIORITY||Difference in % Participants|0.8||||0.686|TWO_SIDED|95.0|-1.6|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||3.4|-1.6|0.686
91487204|NCT06350474|182846817|SUPERIORITY||Difference in % Participants|13.9||||0.001|TWO_SIDED|95.0|5.6|21.8|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||21.8|5.6|0.0010
91679727|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.48|1.33|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.48|<0.001
91679728|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.089|TWO_SIDED|95.0|-0.06|0.8|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.80|-0.06|0.089
91679729|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.83|0.24|<0.001
91679730|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|||<|0.001|TWO_SIDED|95.0|0.6|1.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.60|<0.001
91679731|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
91679732|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.02|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.02|0.42|<0.001
91679733|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.002|TWO_SIDED|95.0|0.25|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.25|0.002
91679734|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.163|TWO_SIDED|95.0|-0.12|0.72|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|-0.12|0.163
91679735|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.016|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.016
91679736|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68||||0.002|TWO_SIDED|95.0|0.26|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.26|0.002
91679737|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.496|TWO_SIDED|95.0|-0.19|0.4|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.19|0.496
91679738|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.003|TWO_SIDED|95.0|0.16|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.16|0.003
91717906|NCT03558516|183328367|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
91717907|NCT03558516|183328368|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
91487205|NCT06350474|182846818|SUPERIORITY||Rate Ratio|1.95|||<|0.0001|TWO_SIDED|95.0|1.51|2.53|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the DA-discontinue and DA-continue arms are 1486.3 and 1471.4 weeks, respectively. Ratio is Discontinue / Continue.||2.53|1.51|<0.0001
91717908|NCT02065557|183328376|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
91717909|NCT02065557|183328376|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
91717910|NCT02065557|183328376|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.382
91717911|NCT02065557|183328376|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
91717912|NCT02065557|183328376|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
91717913|NCT02065557|183328376|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.344
91487206|NCT06350474|182846819|SUPERIORITY||Difference in % Participants|2.03||||0.1758|TWO_SIDED|95.0|-0.6|5.0|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.0|-0.6|0.1758
91487207|NCT00546104|182846822|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|9.0||0.3|TWO_SIDED|95.0|-30.0|9.0||The p-value is from a paired t-test to test the null hypothesis the mean relative change in Src from baseline to 4 weeks is equal to zero.|t-test, 2 sided|||The median change in SRC from baseline to 4 weeks was estimated.||9|-30|0.3
91487208|NCT00546104|182846823|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.3|TWO_SIDED|95.0|-0.3|0.1|||t-test, 1 sided|||||.10|-.30|0.3
91487209|NCT02699697|182846832|SUPERIORITY||Hazard Ratio (HR)|0.869||||0.8325|TWO_SIDED||||||t-test, 2 sided|||||||0.8325
91487210|NCT02699697|182846833|SUPERIORITY|||||||0.5593|||||||t-test, 2 sided|||Continuous pain scale p-value at 3 months||||0.5593
91487211|NCT02699697|182846833|SUPERIORITY|||||||0.8133|||||||t-test, 2 sided|||Continuous pain scale p-value at 6 months||||0.8133
91487212|NCT02699697|182846834|SUPERIORITY|||||||0.3058|||||||t-test, 2 sided|||Narcotic use at 3 months||||0.3058
91487213|NCT02699697|182846834|SUPERIORITY|||||||0.5337|||||||t-test, 2 sided|||Narcotic use at 6 months||||0.5337
91526797|NCT03029247|182929113|SUPERIORITY||LS Mean Difference|-0.13||||0.9353|TWO_SIDED|95.0|-3.41|3.14||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||3.14|-3.41|0.9353
91527574|NCT01976364|182930469|OTHER||LS Mean Difference|-0.024|||||TWO_SIDED|95.0|-0.266|0.219||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.219|-0.266|
91679739|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.008|TWO_SIDED|95.0|0.15|1.0|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.15|0.008
91679740|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.315|TWO_SIDED|95.0|-0.21|0.64|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.21|0.315
91679741|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.019|TWO_SIDED|95.0|0.06|0.66|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.06|0.019
91679742|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.038|TWO_SIDED|95.0|0.02|0.87|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.87|0.02|0.038
91679743|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.918|TWO_SIDED|95.0|-0.28|0.31|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.28|0.918
91679744|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.105|TWO_SIDED|95.0|-0.05|0.55|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|-0.05|0.105
91679745|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.045|TWO_SIDED|95.0|0.01|0.85|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.01|0.045
91679746|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.355|TWO_SIDED|95.0|-0.22|0.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.22|0.355
91679747|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.127|TWO_SIDED|95.0|-0.07|0.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.07|0.127
91679748|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.171|TWO_SIDED|95.0|-0.12|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.12|0.171
91679749|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.79|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.25|0.790
91717914|NCT02065557|183328377|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91679750|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.235|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.47|-0.12|0.235
91679751|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.236|TWO_SIDED|95.0|-0.16|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|-0.16|0.236
91487214|NCT02699697|182846835|SUPERIORITY|||||||0.4182|||||||t-test, 2 sided|||Physical Functioning p-value at 3 months||||0.4182
91487215|NCT02699697|182846835|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Emotional functioning p-value at 3 months||||0.8700
91487216|NCT02699697|182846835|SUPERIORITY|||||||0.7008|||||||t-test, 2 sided|||Symptom Scales - Dyspnea at 3 months||||0.7008
91487217|NCT02699697|182846835|SUPERIORITY|||||||0.9562|||||||t-test, 2 sided|||Symptom Scale Pain at 3 months||||0.9562
91487218|NCT02699697|182846835|SUPERIORITY|||||||0.4951|||||||t-test, 2 sided|||Symptom Scale Insomnia at 3 months||||0.4951
91487219|NCT02699697|182846835|SUPERIORITY|||||||0.7868|||||||t-test, 2 sided|||Symptom Scale Fatigue at 3 months||||0.7868
91487220|NCT02699697|182846835|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||Symptom Scale Appetite loss at 3 months||||0.2200
91679752|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.599|TWO_SIDED|95.0|-0.3|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.30|0.599
91679753|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.353|TWO_SIDED|95.0|-0.15|0.43|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.15|0.353
91679754|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.293|TWO_SIDED|95.0|-0.19|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.19|0.293
91679755|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.986|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.28|0.986
91679756|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.459|TWO_SIDED|95.0|-0.18|0.39|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|-0.18|0.459
91717915|NCT02065557|183328377|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717916|NCT02065557|183328377|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
91717917|NCT02065557|183328377|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717918|NCT02065557|183328377|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717919|NCT02065557|183328377|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
91717920|NCT02065557|183328378|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717921|NCT02065557|183328378|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717922|NCT02065557|183328378|SUPERIORITY|one-sample two-sided Chi-square test||||||0.008||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.008
91679757|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.287|TWO_SIDED|95.0|-0.18|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.18|0.287
91679758|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6|TWO_SIDED|95.0|-0.3|0.51|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.30|0.600
91679759|NCT02912650|183251775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.447|TWO_SIDED|95.0|-0.17|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.17|0.447
91679760|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.001|TWO_SIDED|95.0|0.23|0.96|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|0.23|0.001
91679761|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.297|TWO_SIDED|95.0|-0.12|0.39|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.39|-0.12|0.297
91487221|NCT02699697|182846835|SUPERIORITY|||||||0.7998|||||||t-test, 2 sided|||Symptom Scale Nausea/vomiting at 3 months||||0.7998
91679762|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.457|TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.16|-0.35|0.457
91679763|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.012|TWO_SIDED|95.0|0.1|0.82|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.82|0.10|0.012
91679764|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.33|1.06|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|0.33|<0.001
91679765|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.076|TWO_SIDED|95.0|-0.49|0.02|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.02|-0.49|0.076
91679766|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.03|||<|0.001|TWO_SIDED|95.0|1.42|2.63|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.63|1.42|<0.001
91679767|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.016|TWO_SIDED|95.0|0.1|0.93|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.93|0.10|0.016
91487222|NCT02699697|182846835|SUPERIORITY|||||||0.7998|||||||t-test, 2 sided|||Symptom Scale Constipation at 3 months||||0.7998
91487223|NCT02699697|182846835|SUPERIORITY|||||||0.7409|||||||t-test, 2 sided|||Symptom Scale Quality of Life at 3 months||||0.7409
91487224|NCT02699697|182846835|SUPERIORITY|||||||0.0128|||||||t-test, 2 sided|||Physical Functioning at 6 months||||0.0128
91487225|NCT02699697|182846835|SUPERIORITY|||||||0.5861|||||||t-test, 2 sided|||Emotional Functioning at 6 months||||0.5861
91487226|NCT02699697|182846835|SUPERIORITY|||||||0.3561|||||||t-test, 2 sided|||Symptom Scales - Dyspnea at 6 months||||0.3561
91487227|NCT02699697|182846835|SUPERIORITY|||||||0.1647|||||||t-test, 2 sided|||Symptom Scales - Pain at 6 months||||0.1647
91526798|NCT03029247|182929114|SUPERIORITY||LS Mean Difference|-144.97||||0.2573|TWO_SIDED|95.0|-399.71|109.76||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||109.76|-399.71|0.2573
91679768|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.33|TWO_SIDED|95.0|-0.21|0.64|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.64|-0.21|0.330
91679769|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.11|0.91|<0.001
91679770|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.21|2.42|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|1.21|<0.001
91679771|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.163|TWO_SIDED|95.0|-0.73|0.12|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.12|-0.73|0.163
91679772|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.91|||<|0.001|TWO_SIDED|95.0|3.18|4.65|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.65|3.18|<0.001
91679773|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.001|TWO_SIDED|95.0|0.35|1.38|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.35|0.001
91679774|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.003|TWO_SIDED|95.0|0.26|1.31|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.31|0.26|0.003
91679775|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.32|3.79|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.79|2.32|<0.001
91679776|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|||<|0.001|TWO_SIDED|95.0|2.39|3.87|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.87|2.39|<0.001
91526799|NCT03029247|182929114|SUPERIORITY||LS Mean Difference|-117.49||||0.045|TWO_SIDED|95.0|-232.26|-2.72||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||-2.72|-232.26|0.0450
91679777|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.769|TWO_SIDED|95.0|-0.6|0.44|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.44|-0.60|0.769
91679778|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|4.65|||<|0.001|TWO_SIDED|95.0|3.88|5.42|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.42|3.88|<0.001
91679779|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.002|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.40|0.32|0.002
91679780|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|0.83|1.93|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.93|0.83|<0.001
91679781|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.79|||<|0.001|TWO_SIDED|95.0|3.02|4.56|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.56|3.02|<0.001
91679782|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.001|TWO_SIDED|95.0|2.49|4.04|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.04|2.49|<0.001
91679783|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.062|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|-0.03|0.062
91679784|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|4.83|||<|0.001|TWO_SIDED|95.0|4.01|5.64|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|4.01|<0.001
91679785|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.009|TWO_SIDED|95.0|0.19|1.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.33|0.19|0.009
91679786|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.17|2.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.33|1.17|<0.001
91679787|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|4.06|||<|0.001|TWO_SIDED|95.0|3.25|4.88|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.88|3.25|<0.001
91679788|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08|||<|0.001|TWO_SIDED|95.0|2.26|3.9|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.90|2.26|<0.001
91679789|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.41|1.56|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.41|<0.001
91679790|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|4.67|||<|0.001|TWO_SIDED|95.0|3.82|5.52|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.52|3.82|<0.001
91679791|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.38|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.19|0.010
91679792|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.41|||<|0.001|TWO_SIDED|95.0|1.81|3.01|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.01|1.81|<0.001
91679793|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.89|||<|0.001|TWO_SIDED|95.0|3.04|4.74|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.74|3.04|<0.001
91487228|NCT02699697|182846835|SUPERIORITY|||||||0.3571|||||||t-test, 2 sided|||Symptom Scales - Insomnia at 6 months||||0.3571
91717923|NCT02065557|183328378|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91487229|NCT02699697|182846835|SUPERIORITY|||||||0.1494|||||||t-test, 2 sided|||Symptom Scales - Fatigue at 6 months||||0.1494
91526800|NCT03029247|182929114|SUPERIORITY||LS Mean Difference|-131.94||||0.1341|TWO_SIDED|95.0|-306.24|42.36||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||42.36|-306.24|0.1341
91679794|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.11|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.11|1.40|<0.001
91679795|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|1.02|2.23|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.23|1.02|<0.001
91679796|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|4.53|||<|0.001|TWO_SIDED|95.0|3.65|5.4|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.40|3.65|<0.001
91679797|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.009|TWO_SIDED|95.0|0.21|1.43|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.43|0.21|0.009
91679798|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.42|||<|0.001|TWO_SIDED|95.0|1.79|3.04|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.04|1.79|<0.001
91679799|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|||<|0.001|TWO_SIDED|95.0|2.83|4.58|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.58|2.83|<0.001
91487230|NCT02699697|182846835|SUPERIORITY|||||||0.8424|||||||t-test, 2 sided|||Symptom Scales - Appetite loss at 6 months||||0.8424
91487231|NCT02699697|182846835|SUPERIORITY|||||||0.3287|||||||t-test, 2 sided|||Symptom Scales - Nausea/vomiting at 6 months||||0.3287
91487232|NCT02699697|182846835|SUPERIORITY|||||||0.0961|||||||t-test, 2 sided|||Symptom Scales - Constipation at 6 months||||0.0961
91487233|NCT02699697|182846837|SUPERIORITY|||||||0.8444|||||||t-test, 2 sided|||At 3 months, total score for PSCC-18||||0.8444
91487234|NCT02699697|182846837|SUPERIORITY|||||||0.8946|||||||t-test, 2 sided|||At 6 months, total score for PSCC-18||||0.8946
91487235|NCT02699697|182846838|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Perceived helplessness total at 3 months||||0.6700
91487236|NCT02699697|182846838|SUPERIORITY|||||||0.435|||||||t-test, 2 sided|||Perceived self-efficacy total at 3 months||||0.4350
91679800|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.23|2.99|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.99|1.23|<0.001
91679801|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.97|2.22|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.22|0.97|<0.001
91679802|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|4.27|||<|0.001|TWO_SIDED|95.0|3.37|5.17|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.17|3.37|<0.001
91679803|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.012|TWO_SIDED|95.0|0.18|1.44|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.44|0.18|0.012
91679804|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.72|3.0|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.00|1.72|<0.001
91679805|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.47|||<|0.001|TWO_SIDED|95.0|2.57|4.36|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.36|2.57|<0.001
91679806|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.82|1.00|<0.001
91679807|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|0.92|2.19|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.19|0.92|<0.001
91679808|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.68|||<|0.001|TWO_SIDED|95.0|2.76|4.6|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.60|2.76|<0.001
91679809|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.055|TWO_SIDED|95.0|-0.01|1.27|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.27|-0.01|0.055
91679810|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.19|||<|0.001|TWO_SIDED|95.0|1.54|2.84|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.54|<0.001
91679811|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.14|3.97|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.97|2.14|<0.001
91679812|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.002|TWO_SIDED|95.0|0.57|2.42|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|0.57|0.002
91679813|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|0.91|2.21|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.21|0.91|<0.001
91679814|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.17|4.03|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.03|2.17|<0.001
91679815|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.049|TWO_SIDED|95.0|0.0|1.3|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.30|0.00|0.049
91679816|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|||<|0.001|TWO_SIDED|95.0|1.27|2.59|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.59|1.27|<0.001
91679817|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.44|||<|0.001|TWO_SIDED|95.0|1.52|3.37|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.37|1.52|<0.001
91679818|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.015|TWO_SIDED|95.0|0.23|2.1|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.10|0.23|0.015
91679819|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|0.62|1.94|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.62|<0.001
91679820|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.56|3.4|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.40|1.56|<0.001
91679821|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.087|TWO_SIDED|95.0|-0.08|1.2|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.20|-0.08|0.087
91679822|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.47|||<|0.001|TWO_SIDED|95.0|0.82|2.12|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.82|<0.001
91487237|NCT02699697|182846838|SUPERIORITY|||||||0.6131|||||||t-test, 2 sided|||Total PSS-10 score at 3 months||||0.6131
91487238|NCT02699697|182846838|SUPERIORITY|||||||0.2518|||||||t-test, 2 sided|||Perceived helplessness total at 6 months||||0.2518
91487239|NCT02699697|182846838|SUPERIORITY|||||||0.5529|||||||t-test, 2 sided|||Perceived self-efficacy total||||0.5529
91487240|NCT02699697|182846838|SUPERIORITY|||||||0.2833|||||||t-test, 2 sided|||Total PSS-10 score at 6 months||||0.2833
91487241|NCT02699697|182846839|SUPERIORITY|||||||0.3784|||||||t-test, 2 sided|||Appraisal Support subscale total at 3 months||||0.3784
91487242|NCT02699697|182846839|SUPERIORITY|||||||0.664|||||||t-test, 2 sided|||Belonging Support subscale total at 3 months||||0.6640
91487243|NCT02699697|182846839|SUPERIORITY|||||||0.1745|||||||t-test, 2 sided|||Tangible Support subscale total at 3 months||||0.1745
91679823|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|||<|0.001|TWO_SIDED|95.0|1.0|2.84|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.00|<0.001
91717924|NCT02065557|183328378|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717925|NCT02065557|183328378|SUPERIORITY|one-sample two-sided Chi-square test||||||0.038||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.038
91717926|NCT02065557|183328379|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717927|NCT02065557|183328379|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717928|NCT02065557|183328379|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
91487244|NCT02699697|182846839|SUPERIORITY|||||||0.5792|||||||t-test, 2 sided|||Total ISEL score at 3 months||||0.5792
91679824|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01||||0.032|TWO_SIDED|95.0|0.09|1.94|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.09|0.032
91679825|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.006|TWO_SIDED|95.0|0.26|1.56|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.26|0.006
91679826|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|0.85|2.66|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.66|0.85|<0.001
91679827|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.77|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.77|-0.49|0.669
91679828|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.89||||0.007|TWO_SIDED|95.0|0.24|1.53|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|0.24|0.007
91526801|NCT03029247|182929115|SUPERIORITY||LS Mean Difference|-97.67||||0.1119|TWO_SIDED|95.0|-219.05|23.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||23.71|-219.05|0.1119
91679829|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.71|2.52|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.52|0.71|<0.001
91487245|NCT02699697|182846839|SUPERIORITY|||||||0.6814|||||||t-test, 2 sided|||Appraisal Support subscale total at 6 months||||0.6814
91487246|NCT02699697|182846839|SUPERIORITY|||||||0.5219|||||||t-test, 2 sided|||Belonging Support subscale total at 6 months||||0.5219
91487247|NCT02699697|182846839|SUPERIORITY|||||||0.5516|||||||t-test, 2 sided|||Tangible Support subscale total||||0.5516
91487248|NCT02699697|182846839|SUPERIORITY|||||||0.4329|||||||t-test, 2 sided|||Total ISEL score at 6 months||||0.4329
91487249|NCT00191906|182846864|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.504
91526802|NCT00999661|182929183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.8|STANDARD_DEVIATION|25.12|<|0.0001||95.0|36.6|43.1||One-sample t-test for change from baseline|t-test, 2 sided|||||43.1|36.6|<0.0001
91679830|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.063|TWO_SIDED|95.0|-0.05|1.78|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.78|-0.05|0.063
91679831|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75||||0.022|TWO_SIDED|95.0|0.11|1.39|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|0.11|0.022
91679832|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.008|TWO_SIDED|95.0|0.32|2.12|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.32|0.008
91679833|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.876|TWO_SIDED|95.0|-0.58|0.68|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.68|-0.58|0.876
91679834|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49||||0.134|TWO_SIDED|95.0|-0.15|1.13|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.13|-0.15|0.134
91679835|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.011|TWO_SIDED|95.0|0.27|2.07|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.07|0.27|0.011
91679836|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.112|TWO_SIDED|95.0|-0.17|1.64|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.64|-0.17|0.112
91679837|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.179|TWO_SIDED|95.0|-0.2|1.08|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.08|-0.20|0.179
91679838|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97||||0.032|TWO_SIDED|95.0|0.09|1.85|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.85|0.09|0.032
91679839|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.85|TWO_SIDED|95.0|-0.56|0.67|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.67|-0.56|0.850
91679840|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.311|TWO_SIDED|95.0|-0.3|0.95|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.95|-0.30|0.311
91679841|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.043|TWO_SIDED|95.0|0.03|1.79|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.79|0.03|0.043
91679842|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.154||95.0|-0.24|1.53|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|-0.24|0.154
91679843|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.408|TWO_SIDED|95.0|-0.36|0.89|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.89|-0.36|0.408
91679844|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.065|TWO_SIDED|95.0|-0.05|1.68|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.68|-0.05|0.065
91526803|NCT00999661|182929184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6|STANDARD_DEVIATION|19.79|<|0.0001||95.0|34.0|39.2|||t-test, 2 sided|||||39.2|34.0|<0.0001
91526804|NCT00999661|182929185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|STANDARD_DEVIATION|5.233|<|0.0001||95.0|-8.65|-7.29|||t-test, 2 sided|||||-7.29|-8.65|<0.0001
91527575|NCT01976364|182930469|OTHER||LS Mean Difference|0.213|||||TWO_SIDED|95.0|-0.045|0.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.470|-0.045|
91679845|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.862|TWO_SIDED|95.0|-0.66|0.55|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.55|-0.66|0.862
91679846|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.352|TWO_SIDED|95.0|-0.32|0.9|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.90|-0.32|0.352
91679847|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.87||||0.049|TWO_SIDED|95.0|0.0|1.73|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.73|0.00|0.049
91717929|NCT02065557|183328379|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717930|NCT02065557|183328379|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717931|NCT02065557|183328379|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
91717932|NCT02065557|183328380|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717933|NCT02065557|183328380|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717934|NCT02065557|183328380|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
91717935|NCT02065557|183328380|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717936|NCT02065557|183328380|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
91717937|NCT02065557|183328380|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
91717938|NCT02065557|183328381|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
91526805|NCT00312858|182929186|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|0.7|||<|0.001||95.0|-1.4|3.8||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.||3.8|-1.4|<0.001
91679848|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.239|TWO_SIDED|95.0|-0.35|1.39|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|-0.35|0.239
91679849|NCT02912650|183251776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.27|TWO_SIDED|95.0|-0.27|0.96|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|-0.27|0.270
91679850|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.031|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.031
91679851|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.527|TWO_SIDED|95.0|-0.06|0.12|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.06|0.527
91679852|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.386|TWO_SIDED|95.0|-0.14|0.05|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.05|-0.14|0.386
91679853|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.084|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.25|-0.02|0.084
91679854|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.006|TWO_SIDED|95.0|0.06|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|0.06|0.006
91679855|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.135|TWO_SIDED|95.0|-0.17|0.02|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.02|-0.17|0.135
91679856|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
91679857|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.062|TWO_SIDED|95.0|-0.01|0.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.27|-0.01|0.062
91679858|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.977|TWO_SIDED|95.0|-0.14|0.14|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.14|0.977
91679859|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.6|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.21|<0.001
91679860|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
91679861|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.069|TWO_SIDED|95.0|-0.27|0.01|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.01|-0.27|0.069
91679862|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.9|1.38|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.90|<0.001
91679863|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.46|0.12|<0.001
91679864|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.011|TWO_SIDED|95.0|0.05|0.39|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|0.05|0.011
91679865|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.61|1.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.61|< 0.001
91679866|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|||<|0.001|TWO_SIDED|95.0|0.67|1.16|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.16|0.67|<0.001
91679867|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.427|TWO_SIDED|95.0|-0.24|0.1|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.10|-0.24|0.427
91487250|NCT00191906|182846865|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.||||0.970
91487251|NCT00191906|182846866|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.579
91487252|NCT00191906|182846866|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.||||0.144
91679868|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|1.11|1.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.60|1.11|<0.001
91679869|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.002|TWO_SIDED|95.0|0.1|0.44|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.10|0.002
91679870|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.23|0.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.23|<0.001
91717939|NCT02065557|183328381|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
91717940|NCT02065557|183328381|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
91717941|NCT02065557|183328381|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
91717942|NCT02065557|183328381|SUPERIORITY|one-sample two-sided Chi-square test||||||0.559||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.559
91717943|NCT02065557|183328381|SUPERIORITY|one-sample two-sided Chi-square test||||||0.815||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.815
91717944|NCT01462942|183328392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125|||<|0.0001|TWO_SIDED|95.0|0.09|0.16|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.160|0.090|<0.0001
91717945|NCT01462942|183328392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.069||||0.0001|TWO_SIDED|95.0|0.034|0.105|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.105|0.034|0.0001
91717946|NCT01462942|183328393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085|||<|0.0001|TWO_SIDED|95.0|0.051|0.119|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.119|0.051|<0.0001
91717947|NCT01462942|183328393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.053||||0.0022|TWO_SIDED|95.0|0.019|0.087|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.087|0.019|0.0022
91487253|NCT00191906|182846867|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.005
91527576|NCT01976364|182930469|OTHER||LS Mean Difference|-0.061|||||TWO_SIDED|95.0|-0.309|0.188||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.188|-0.309|
91487254|NCT00191906|182846868|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.097
91717948|NCT01462942|183328394|SUPERIORITY_OR_OTHER||Least squares mean difference|1.293|||<|0.0001|TWO_SIDED|95.0|0.728|1.859|||Mixed Models Analysis|Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.859|0.728|<0.0001
91679871|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.84|1.33|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.84|<0.001
91679872|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95|||<|0.001|TWO_SIDED|95.0|0.7|1.2|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.70|<0.001
91679873|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.123|TWO_SIDED|95.0|-0.04|0.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.04|0.123
91679874|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|1.14|1.67|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|1.14|<0.001
91679875|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.012|TWO_SIDED|95.0|0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.05|0.012
91679876|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.38|0.75|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.75|0.38|<0.001
91679877|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|||<|0.001|TWO_SIDED|95.0|0.9|1.43|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.90|<0.001
91679878|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.11|0.57|<0.001
91679879|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|0.14|<0.001
91527577|NCT01976364|182930470|OTHER||Difference in percentage of participants|-0.14|||||TWO_SIDED|95.0|-9.76|9.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||9.48|-9.76|
91679880|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|1.11|1.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|1.11|<0.001
91679881|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.002|TWO_SIDED|95.0|0.11|0.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.48|0.11|0.002
91679882|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.56|0.95|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.56|<0.001
91679883|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.82|<0.001
91679884|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|||<|0.001|TWO_SIDED|95.0|0.35|0.9|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|0.35|<0.001
91679885|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||<|0.001|TWO_SIDED|95.0|0.27|0.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.27|<0.001
91679886|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|1.06|1.61|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|1.06|<0.001
91679887|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.49|0.10|0.003
91679888|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|||<|0.001|TWO_SIDED|95.0|0.58|0.98|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.98|0.58|<0.001
91679889|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.76|1.32|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|0.76|<0.001
91679890|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|<0.001
91679891|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.29|0.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.29|<0.001
91679892|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|1.00|<0.001
91679893|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.50|0.10|0.003
91679894|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.51|0.91|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.51|<0.001
91679895|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
91679896|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.29|0.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.29|<0.001
91679897|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
91679898|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.001|TWO_SIDED|95.0|0.81|1.38|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.81|<0.001
91679899|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.014|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.014
91679900|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.45|0.86|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.45|<0.001
91679901|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.56|1.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.13|0.56|<0.001
91679902|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.003|TWO_SIDED|95.0|0.15|0.73|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.15|0.003
91679903|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
91679904|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|||<|0.001|TWO_SIDED|95.0|0.62|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.62|<0.001
91679905|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.041|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.01|0.041
91679906|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.35|0.76|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.35|<0.001
91679907|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.41|0.99|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.99|0.41|<0.001
91527578|NCT01976364|182930470|OTHER||Difference in percentage of participants|-4.57|||||TWO_SIDED|95.0|-12.91|3.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||3.77|-12.91|
91679908|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
91679909|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.001|TWO_SIDED|95.0|0.14|0.55|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|0.14|0.001
91679910|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.48|1.05|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.48|<0.001
91679911|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.045|TWO_SIDED|95.0|0.0|0.4|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|0.00|0.045
91679912|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.24|0.64|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.24|<0.001
91679913|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|< 0.001
91679914|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.027|TWO_SIDED|95.0|0.04|0.61|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.04|0.027
91679915|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.04|0.020
91679916|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.29|0.85|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.29|<0.001
91679917|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.374|TWO_SIDED|95.0|-0.11|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.11|0.374
91679918|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.14|0.54|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|0.14|<0.001
91679919|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.2|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.20|<0.001
91679920|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.106|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.106
91679921|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.013|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.013
91679922|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.006|TWO_SIDED|95.0|0.11|0.67|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.11|0.006
91679923|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.796|TWO_SIDED|95.0|-0.17|0.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.22|-0.17|0.796
91679924|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.104|TWO_SIDED|95.0|-0.03|0.36|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.36|-0.03|0.104
91679925|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.01|TWO_SIDED|95.0|0.09|0.65|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.09|0.010
91679926|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.114|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.114
91679927|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.168|TWO_SIDED|95.0|-0.06|0.34|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.34|-0.06|0.168
91679928|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.022|TWO_SIDED|95.0|0.05|0.59|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.59|0.05|0.022
91679929|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.62|TWO_SIDED|95.0|-0.14|0.24|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.24|-0.14|0.620
91679930|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.164|TWO_SIDED|95.0|-0.06|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.06|0.164
91527579|NCT01976364|182930470|OTHER||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.26|2.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||2.87|-14.26|
91679931|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.052|TWO_SIDED|95.0|0.0|0.54|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|-0.00|0.052
91679932|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.196|TWO_SIDED|95.0|-0.09|0.45|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|-0.09|0.196
91679933|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.364|TWO_SIDED|95.0|-0.1|0.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.10|0.364
91679934|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.071|TWO_SIDED|95.0|-0.02|0.52|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.02|0.071
91679935|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.865||95.0|-0.2|0.17|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.20|0.865
91679936|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.238|TWO_SIDED|95.0|-0.08|0.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.30|-0.08|0.238
91679937|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.054|TWO_SIDED|95.0|0.0|0.53|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.00|0.054
91679938|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.335|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.14|0.335
91679939|NCT02912650|183251777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.176|TWO_SIDED|95.0|-0.06|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.06|0.176
91679940|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.77|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.77|0.18|0.002
91679941|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.098|TWO_SIDED|95.0|-0.03|0.38|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.38|-0.03|0.098
91679942|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.719|TWO_SIDED|95.0|-0.25|0.17|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.25|0.719
91679943|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.048|TWO_SIDED|95.0|0.0|0.6|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.00|0.048
91679944|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|||<|0.001|TWO_SIDED|95.0|0.21|0.81|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.81|0.21|<0.001
91679945|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.046|TWO_SIDED|95.0|-0.42|0.0|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.00|-0.42|0.046
91487255|NCT00191906|182846869|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.003
91679946|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.52|||<|0.001|TWO_SIDED|95.0|1.05|1.99|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.99|1.05|<0.001
91679947|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.069|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|-0.02|0.069
91679948|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.604|TWO_SIDED|95.0|-0.24|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|-0.24|0.604
91679949|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.75|1.69|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.75|<0.001
91679950|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|||<|0.001|TWO_SIDED|95.0|0.96|1.9|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.90|0.96|<0.001
91679951|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.2|TWO_SIDED|95.0|-0.54|0.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.11|-0.54|0.200
91679952|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.89|||<|0.001|TWO_SIDED|95.0|2.32|3.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.46|2.32|<0.001
91679953|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
91679954|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.008|TWO_SIDED|95.0|0.14|0.95|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.14|0.008
91679955|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.83|1.69|<0.001
91679956|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|||<|0.001|TWO_SIDED|95.0|1.77|2.91|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.91|1.77|<0.001
91679957|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.685|TWO_SIDED|95.0|-0.49|0.32|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.49|0.685
91679958|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|2.77|3.93|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.93|2.77|<0.001
91679959|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.001|TWO_SIDED|95.0|0.26|1.07|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.07|0.26|0.001
91679960|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.57|1.39|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.39|0.57|<0.001
91679961|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|2.11|3.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.27|2.11|<0.001
91679962|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.79|2.96|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.79|<0.001
91679963|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.132|TWO_SIDED|95.0|-0.1|0.73|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|-0.10|0.132
91679964|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|||<|0.001|TWO_SIDED|95.0|2.88|4.13|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.13|2.88|<0.001
91679965|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.007|TWO_SIDED|95.0|0.17|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.17|0.007
91679966|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35|||<|0.001|TWO_SIDED|95.0|0.91|1.8|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.80|0.91|<0.001
91679967|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.27|3.52|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.52|2.27|<0.001
91679968|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.001|TWO_SIDED|95.0|1.52|2.79|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.79|1.52|<0.001
91487256|NCT00191906|182846870|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
91717949|NCT01462942|183328394|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.162|||<|0.0001|TWO_SIDED|95.0|0.593|1.73|||Mixed Models Analysis|||Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||1.730|0.593|<0.0001
91717950|NCT01462942|183328395|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.653||||0.598|TWO_SIDED|95.0|-3.082|1.776|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.776|-3.082|0.5980
91717951|NCT01462942|183328395|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.828||||0.1406|TWO_SIDED|95.0|-4.259|0.604|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||0.604|-4.259|0.1406
91717952|NCT02737722|183328397|SUPERIORITY|||||||0.5152|||||||Fisher Exact|||Day 1 (Visit 2)||||0.5152
91717953|NCT02737722|183328397|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 1 (Visit 2)||||1.0000
91717954|NCT02737722|183328397|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
91679969|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.001|TWO_SIDED|95.0|0.3|1.19|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.30|0.001
91679970|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|||<|0.001|TWO_SIDED|95.0|2.79|4.09|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.09|2.79|<0.001
91679971|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.003|TWO_SIDED|95.0|0.24|1.15|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.15|0.24|0.003
91679972|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.39|2.31|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.39|<0.001
91679973|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.74|||<|0.001|TWO_SIDED|95.0|2.1|3.39|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.39|2.10|<0.001
91679974|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.94|2.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|0.94|< 0.001
91527580|NCT01976364|182930470|OTHER||Difference in percentage of participants|-2.36|||||TWO_SIDED|95.0|-11.59|6.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||6.87|-11.59|
91679975|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|||<|0.001|TWO_SIDED|95.0|0.69|1.61|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.69|<0.001
91679976|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|||<|0.001|TWO_SIDED|95.0|2.67|4.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|2.67|<0.001
91679977|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.002|TWO_SIDED|95.0|0.27|1.2|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.27|0.002
91679978|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|1.47|2.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.41|1.47|<0.001
91717955|NCT02737722|183328397|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
91717956|NCT02737722|183328397|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
91717957|NCT02737722|183328397|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
91717958|NCT02737722|183328397|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 15 (Visit 5)||||1.0000
91717959|NCT02737722|183328397|SUPERIORITY|||||||0.3636|||||||Fisher Exact|||Day 15 (Visit 5)||||0.3636
91717960|NCT02737722|183328398|SUPERIORITY|||||||0.172|||||||Wilcoxon Rank Sum Test|||||||0.172
91717961|NCT02737722|183328398|SUPERIORITY|||||||0.365|||||||Wilcoxon Rank Sum Test|||||||0.365
91717962|NCT02737722|183328398|SUPERIORITY|||||||0.619|||||||Wilcoxon Rank Sum Test|||||||0.619
91717963|NCT02737722|183328399|SUPERIORITY|||||||0.432|||||||Wilcoxon Rank Sum Test|||||||0.432
91717964|NCT02737722|183328399|SUPERIORITY|||||||0.435|||||||Wilcoxon Rank Sum Test|||||||0.435
91717965|NCT02737722|183328399|SUPERIORITY|||||||0.715|||||||Wilcoxon Rank Sum Test|||||||0.715
91717966|NCT02737722|183328400|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
91717967|NCT02737722|183328400|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
91717968|NCT02737722|183328400|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
91717969|NCT02737722|183328401|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
91717970|NCT02737722|183328401|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
91717971|NCT02737722|183328401|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
91717972|NCT02737722|183328402|SUPERIORITY|||||||0.361|||||||Wilcoxon Rank Sum Test|||||||0.361
91717973|NCT02737722|183328402|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
91526806|NCT00312858|182929187|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|-5.1||||0.013||95.0|-9.3|-1.4||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \<1.25 gpELISA units/mL||-1.4|-9.3|0.013
91679979|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.93|3.26|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|1.93|<0.001
91679980|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|0.73|2.07|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.07|0.73|<0.001
91679981|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.73|1.67|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|0.73|<0.001
91679982|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|2.51|3.87|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.87|2.51|<0.001
91679983|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.002|TWO_SIDED|95.0|0.29|1.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.23|0.29|0.002
91679984|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.37|2.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.33|1.37|< 0.001
91679985|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.43|||<|0.001|TWO_SIDED|95.0|1.75|3.11|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.11|1.75|<0.001
91679986|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|0.66|2.03|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.03|0.66|<0.001
91679987|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.61|1.56|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.56|0.61|<0.001
91679988|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.65|||<|0.001|TWO_SIDED|95.0|1.95|3.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.35|1.95|<0.001
91679989|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
91679990|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.24|2.22|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.22|1.24|<0.001
91679991|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.05|||<|0.001|TWO_SIDED|95.0|1.35|2.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.74|1.35|<0.001
91679992|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92||||0.01|TWO_SIDED|95.0|0.22|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.22|0.010
91679993|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12|||<|0.001|TWO_SIDED|95.0|0.63|1.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.63|<0.001
91679994|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||<|0.001|TWO_SIDED|95.0|1.47|2.88|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.88|1.47|<0.001
91679995|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.022|TWO_SIDED|95.0|0.08|1.06|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.06|0.08|0.022
91679996|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.95|1.95|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|0.95|<0.001
91679997|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.9|2.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.30|0.90|<0.001
91679998|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.045|TWO_SIDED|95.0|0.02|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.02|0.045
91679999|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.88|||<|0.001|TWO_SIDED|95.0|0.38|1.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.38|<0.001
91680000|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78|||<|0.001|TWO_SIDED|95.0|1.09|2.47|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|1.09|<0.001
91680001|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.024|TWO_SIDED|95.0|0.07|1.04|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.04|0.07|0.024
91680002|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.67|1.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|0.67|<0.001
91717974|NCT02737722|183328402|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
91487257|NCT00191906|182846871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
91680003|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23|||<|0.001|TWO_SIDED|95.0|0.54|1.92|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.54|<0.001
91680004|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62||||0.079|TWO_SIDED|95.0|-0.07|1.32|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|-0.07|0.079
91680005|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
91680006|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|||<|0.001|TWO_SIDED|95.0|0.56|1.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.56|<0.001
91680007|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.438|TWO_SIDED|95.0|-0.29|0.67|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|-0.29|0.438
91680008|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.001|TWO_SIDED|95.0|0.31|1.29|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.29|0.31|0.001
91680009|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.003|TWO_SIDED|95.0|0.37|1.75|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|0.37|0.003
91680010|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.204|TWO_SIDED|95.0|-0.25|1.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.25|0.204
91680011|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.014|TWO_SIDED|95.0|0.12|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.12|0.014
91680012|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.018|TWO_SIDED|95.0|0.15|1.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.53|0.15|0.018
91680013|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.867|TWO_SIDED|95.0|-0.44|0.52|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.44|0.867
91526807|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 4||1.3|0.9|<0.001
91680014|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.08|0.099
91680015|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.024|TWO_SIDED|95.0|0.11|1.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.49|0.11|0.024
91680016|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.228|TWO_SIDED|95.0|-0.27|1.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.27|0.228
91680017|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.136|TWO_SIDED|95.0|-0.12|0.86|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|-0.12|0.136
91680018|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.078|TWO_SIDED|95.0|-0.07|1.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.28|-0.07|0.078
91680019|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.716|TWO_SIDED|95.0|-0.38|0.56|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.56|-0.38|0.716
91680020|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.197|TWO_SIDED|95.0|-0.16|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.79|-0.16|0.197
91680021|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.131|TWO_SIDED|95.0|-0.15|1.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|-0.15|0.131
91680022|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.399|TWO_SIDED|95.0|-0.39|0.97|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|-0.39|0.399
91680023|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.349|TWO_SIDED|95.0|-0.25|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.25|0.349
91680024|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.169|TWO_SIDED|95.0|-0.2|1.12|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.20|0.169
91680025|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.937|TWO_SIDED|95.0|-0.48|0.44|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|-0.48|0.937
91680026|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.351|TWO_SIDED|95.0|-0.25|0.69|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.69|-0.25|0.351
91680027|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.151|TWO_SIDED|95.0|-0.18|1.14|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.18|0.151
91680028|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.476|TWO_SIDED|95.0|-0.42|0.9|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.42|0.476
91680029|NCT02912650|183251778|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.31|TWO_SIDED|95.0|-0.22|0.71|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|-0.22|0.310
91680030|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|7.35|||<|0.001|TWO_SIDED|95.0|6.09|8.61|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||8.61|6.09|<0.001
91680031|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41||||0.002|TWO_SIDED|95.0|0.53|2.28|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.28|0.53|0.002
91680032|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.09|2.88|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.88|1.09|<0.001
91680033|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|5.94|||<|0.001|TWO_SIDED|95.0|4.69|7.2|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.20|4.69|<0.001
91680034|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.1|6.63|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.63|4.10|<0.001
91680035|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58||||0.203|TWO_SIDED|95.0|-0.31|1.47|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.47|-0.31|0.203
91680036|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.001|TWO_SIDED|95.0|20.1|28.9|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||28.90|20.10|<0.001
91717975|NCT02737722|183328403|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
91717976|NCT02737722|183328403|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
91680037|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44||||0.005|TWO_SIDED|95.0|1.37|7.52|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.52|1.37|0.005
91680038|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|11.36|||<|0.001|TWO_SIDED|95.0|8.23|14.48|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||14.48|8.23|<0.001
91680039|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|20.06|||<|0.001|TWO_SIDED|95.0|15.66|24.45|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||24.45|15.66|<0.001
91717977|NCT02737722|183328403|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
91717978|NCT02737722|183328405|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
91717979|NCT02737722|183328405|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
91717980|NCT02737722|183328405|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
91722500|NCT06001021|183337810|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008). Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis.~2008;66(2):150-4. PMID: 18537788"|Mean Difference (Final Values)|23.96|STANDARD_DEVIATION|23.14||0|TWO_SIDED|90.0|19.59|28.32||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||28.32|19.59|0.000
91527581|NCT01976364|182930470|OTHER||Difference in percentage of participants|-10.15|||||TWO_SIDED|95.0|-18.16|-2.14||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||-2.14|-18.16|
91717981|NCT02449434|183328406|OTHER|Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).|Odds Ratio (OR)|2.25|||<|0.05|TWO_SIDED|95.0||||Only results from fully adjusted regression models will be deemed as significant|Regression, Logistic|Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals||A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.||||<0.05
91717982|NCT01026493|183328410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.66|1.48|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-NAIVE|||1.48|0.66|0.95
91717983|NCT01026493|183328410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.93|TWO_SIDED|95.0|0.57|1.53|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-FAILURE|||1.53|0.57|0.93
91717984|NCT02662569|183328411|SUPERIORITY||LS Mean Treatment Difference|-70.29|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-75.43|-65.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.16|-75.43|<0.0001
91717985|NCT02662569|183328411|SUPERIORITY||LS Mean Treatment Difference|-70.04|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-74.67|-65.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-65.41|-74.67|<0.0001
91717986|NCT02662569|183328412|SUPERIORITY||LS Mean Treatment Difference|-71.77|STANDARD_ERROR_OF_MEAN|2.97|<|0.0001|TWO_SIDED|95.0|-77.61|-65.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.93|-77.61|<0.0001
91717987|NCT02662569|183328412|SUPERIORITY||LS Mean Treatment Difference|-64.93|STANDARD_ERROR_OF_MEAN|2.56|<|0.0001|TWO_SIDED|95.0|-69.97|-59.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-59.89|-69.97|<0.0001
91717988|NCT02662569|183328413|SUPERIORITY||LS Mean Treatment Difference|-62.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-68.2|-56.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.9|-68.2|<0.0001
91717989|NCT02662569|183328413|SUPERIORITY||LS Mean Treatment Difference|-63.1|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-68.4|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-57.8|-68.4|<0.0001
91717990|NCT02662569|183328414|SUPERIORITY||LS Mean Treatment Difference|-63.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-69.7|-57.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-57.6|-69.7|<0.0001
91717991|NCT02662569|183328414|SUPERIORITY||LS Mean Treatment Difference|-58.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-64.3|-53.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-53.3|-64.3|<0.0001
91717992|NCT02662569|183328415|SUPERIORITY||LS Mean Treatment Difference|-60.9|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-65.51|-56.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.29|-65.51|<0.0001
91526808|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.8|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 6B||1.2|0.8|<0.001
91526809|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 9V||1.0|0.8|<0.001
91717993|NCT02662569|183328415|SUPERIORITY||LS Mean Treatment Difference|-59.4|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-63.52|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-55.29|-63.52|<0.0001
91717994|NCT02662569|183328416|SUPERIORITY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.64|<|0.0001|TWO_SIDED|95.0|-66.82|-56.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.45|-66.82|<0.0001
91717995|NCT02662569|183328416|SUPERIORITY||LS Mean Treatment Difference|-54.22|STANDARD_ERROR_OF_MEAN|2.28|<|0.0001|TWO_SIDED|95.0|-58.7|-49.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-49.74|-58.70|<0.0001
91717996|NCT02662569|183328417|SUPERIORITY||LS Mean Treatment Difference|-56.93|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-60.93|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.93|-60.93|<0.0001
91717997|NCT02662569|183328417|SUPERIORITY||LS Mean Treatment Difference|-54.85|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-58.52|-51.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-51.18|-58.52|<0.0001
91717998|NCT02662569|183328418|SUPERIORITY||LS Mean Treatment Difference|-57.06|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-61.59|-52.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.54|-61.59|<0.0001
91717999|NCT02662569|183328418|SUPERIORITY||LS Mean Treatment Difference|-49.42|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-53.31|-45.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-45.53|-53.31|<0.0001
91718000|NCT02662569|183328419|SUPERIORITY||LS Mean Treatment Difference|-41.53|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-44.95|-38.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.10|-44.95|<0.0001
91718001|NCT02662569|183328419|SUPERIORITY||LS Mean Treatment Difference|-39.5|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-42.47|-36.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-36.53|-42.47|<0.0001
91718002|NCT02662569|183328420|SUPERIORITY||LS Mean Treatment Difference|-42.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-46.02|-38.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.42|-46.02|<0.0001
91718003|NCT02662569|183328420|SUPERIORITY||LS Mean Treatment Difference|-35.89|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-39.12|-32.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-32.67|-39.12|<0.0001
91718004|NCT02662569|183328421|SUPERIORITY||LS Mean Treatment Difference|-44.09|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|-47.64|-40.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-40.54|-47.64|<0.0001
91526810|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 14||1.2|0.9|<0.001
91718005|NCT02662569|183328421|SUPERIORITY||LS Mean Treatment Difference|-43.67|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-46.9|-40.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-40.44|-46.90|<0.0001
91526811|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 18C||1.3|0.9|<0.001
91680040|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|13.14|||<|0.001|TWO_SIDED|95.0|8.71|17.57|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.57|8.71|<0.001
91680041|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|6.92|||<|0.001|TWO_SIDED|95.0|3.8|10.04|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.04|3.80|<0.001
91526812|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 19F||1.2|0.9|<0.001
91526813|NCT00312858|182929188|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|1.0|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 23F||1.3|1.0|<0.001
91680042|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|34.83|||<|0.001|TWO_SIDED|95.0|26.09|43.57|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||43.57|26.09|<0.001
91680043|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|5.85||||0.06|TWO_SIDED|95.0|-0.25|11.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.95|-0.25|0.060
91680044|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|16.75|||<|0.001|TWO_SIDED|95.0|10.54|22.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||22.95|10.54|<0.001
91680045|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|28.98|||<|0.001|TWO_SIDED|95.0|20.26|37.71|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||37.71|20.26|<0.001
91680046|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|18.08|||<|0.001||95.0|9.29|26.88|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||26.88|9.29|<0.001
91680047|NCT02912650|183251779|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9|||<|0.001|TWO_SIDED|95.0|4.7|17.1|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.10|4.70|<0.001
91680048|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|2.12|||<|0.001|TWO_SIDED|95.0|1.72|2.51|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.51|1.72|<0.001
91680049|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.71|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|0.16|0.002
91680050|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.3|0.86|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.30|<0.001
91680051|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.08|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.08|1.29|<0.001
91680052|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|1.14|1.93|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.93|1.14|<0.001
91680053|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.303|TWO_SIDED|95.0|-0.13|0.43|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.13|0.303
91680054|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|7.22|||<|0.001|TWO_SIDED|95.0|5.86|8.58|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.58|5.86|<0.001
91680055|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|1.58||||0.001|TWO_SIDED|95.0|0.63|2.53|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.53|0.63|0.001
91680056|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|3.48|||<|0.001|TWO_SIDED|95.0|2.52|4.45|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.45|2.52|<0.001
91680057|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|||<|0.001|TWO_SIDED|95.0|4.28|6.99|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.99|4.28|<0.001
91680058|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|3.73|||<|0.001|TWO_SIDED|95.0|2.37|5.1|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.10|2.37|<0.001
91680059|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.001|TWO_SIDED|95.0|0.95|2.86|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.86|0.95|<0.001
91680060|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|8.89|||<|0.001|TWO_SIDED|95.0|7.08|10.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|7.08|<0.001
91680061|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.002|TWO_SIDED|95.0|0.73|3.26|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|0.73|0.002
91680062|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|4.48|||<|0.001|TWO_SIDED|95.0|3.2|5.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.77|3.20|<0.001
91680063|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9|||<|0.001|TWO_SIDED|95.0|5.08|8.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.71|5.08|<0.001
91680064|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|4.41|||<|0.001|TWO_SIDED|95.0|2.58|6.24|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.24|2.58|<0.001
91680065|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|2.49|||<|0.001|TWO_SIDED|95.0|1.21|3.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.77|1.21|<0.001
91718006|NCT02662569|183328422|SUPERIORITY||LS Mean Treatment Difference|-43.94|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-47.9|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.97|-47.90|<0.0001
91718007|NCT02662569|183328422|SUPERIORITY||LS Mean Treatment Difference|-40.56|STANDARD_ERROR_OF_MEAN|1.79|<|0.0001|TWO_SIDED|95.0|-44.08|-37.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.04|-44.08|<0.0001
91718008|NCT02662569|183328423|SUPERIORITY||LS Mean Treatment Difference|-58.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-62.15|-54.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.25|-62.15|<0.0001
91718009|NCT02662569|183328423|SUPERIORITY||LS Mean Treatment Difference|-56.73|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-60.53|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-52.93|-60.53|<0.0001
91718010|NCT02662569|183328424|SUPERIORITY||LS Mean Treatment Difference|-58.21|STANDARD_ERROR_OF_MEAN|2.23|<|0.0001|TWO_SIDED|95.0|-62.59|-53.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.84|-62.59|<0.0001
91680066|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|10.42|||<|0.001|TWO_SIDED|95.0|7.76|13.08|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||13.08|7.76|<0.001
91718011|NCT02662569|183328424|SUPERIORITY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-55.81|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-47.59|-55.81|<0.0001
91526814|NCT00252590|182929210|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
91680067|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14||||0.024|TWO_SIDED|95.0|0.28|4.0|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|0.28|0.024
91680068|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|5.24|||<|0.001|TWO_SIDED|95.0|3.35|7.12|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.12|3.35|<0.001
91680069|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|8.28|||<|0.001|TWO_SIDED|95.0|5.62|10.93|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.93|5.62|<0.001
91680070|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|5.18|||<|0.001|TWO_SIDED|95.0|2.51|7.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.86|2.51|<0.001
91680071|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.001|TWO_SIDED|95.0|1.22|4.97|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.97|1.22|0.001
91680072|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.95|3.59|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.59|1.95|<0.001
91680073|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.023|TWO_SIDED|95.0|0.09|1.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.09|0.023
91680074|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.07|2.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|1.07|<0.001
91680075|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.29|2.92|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.92|1.29|<0.001
91680076|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11||||0.008|TWO_SIDED|95.0|0.29|1.94|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.29|0.008
91680077|NCT02912650|183251780|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.41|1.57|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|0.41|<0.001
91680078|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|2.68|3.82|||ANOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.82|2.68|<0.001
91680079|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
91526815|NCT01355419|182929255|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.||||<0.05
91680080|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.27|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.46|<0.001
91680081|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|||<|0.001|TWO_SIDED|95.0|2.05|3.19|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.19|2.05|<0.001
91680082|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|2.39|||<|0.001|TWO_SIDED|95.0|1.81|2.96|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.81|<0.001
91680083|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.258|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.17|0.258
91527582|NCT01976364|182930471|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.1|
91680084|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|10.77|||<|0.001|TWO_SIDED|95.0|8.79|12.74|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.74|8.79|<0.001
91680085|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|2.29||||0.001|TWO_SIDED|95.0|0.91|3.67|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.67|0.91|0.001
91680086|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|5.33|||<|0.001|TWO_SIDED|95.0|3.93|6.73|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.73|3.93|<0.001
91680087|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|8.48|||<|0.001|TWO_SIDED|95.0|6.51|10.44|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.44|6.51|<0.001
91680088|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|5.44|||<|0.001|TWO_SIDED|95.0|3.46|7.42|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.42|3.46|<0.001
91680089|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|3.04|||<|0.001|TWO_SIDED|95.0|1.65|4.43|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.43|1.65|<0.001
91680090|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|14.68|||<|0.001|TWO_SIDED|95.0|10.74|18.62|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.62|10.74|<0.001
91680091|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|3.16||||0.024|TWO_SIDED|95.0|0.41|5.91|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.91|0.41|0.024
91680092|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|7.94|||<|0.001|TWO_SIDED|95.0|5.15|10.73|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.73|5.15|<0.001
91680093|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|||<|0.001|TWO_SIDED|95.0|7.59|15.45|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||15.45|7.59|<0.001
91680094|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|6.75|||<|0.001||95.0|2.79|10.71|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|2.79|<0.001
91680095|NCT02912650|183251781|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|2.0|7.56|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.56|2.0|<0.001
91680096|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.42|6.32|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.32|4.42|<0.001
91680097|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.4|1.74|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.74|0.40|0.002
91680098|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.77|2.13|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.13|0.77|<0.001
91718012|NCT02662569|183328425|SUPERIORITY||Treatment Difference|68.4|||<|0.0001|TWO_SIDED|95.0|60.4|74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||74.8|60.4|<0.0001
91718013|NCT02662569|183328425|SUPERIORITY||Treatment Difference|71.9|||<|0.0001|TWO_SIDED|95.0|64.1|77.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||77.9|64.1|<0.0001
91718014|NCT02662569|183328426|SUPERIORITY||Treatment Difference|67.2|||<|0.0001|TWO_SIDED|95.0|58.9|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||73.9|58.9|<0.0001
91718015|NCT02662569|183328426|SUPERIORITY||Treatment Difference|68.8|||<|0.0001|TWO_SIDED|95.0|60.6|75.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||75.3|60.6|<0.0001
91718016|NCT02662569|183328427|SUPERIORITY||LS Mean Treatment Difference|-55.52|STANDARD_ERROR_OF_MEAN|18.85|<|0.0001|TWO_SIDED|95.0|-92.64|-18.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-18.40|-92.64|<0.0001
91718017|NCT02662569|183328427|SUPERIORITY||LS Mean Treatment Difference|-50.77|STANDARD_ERROR_OF_MEAN|6.63|<|0.0001|TWO_SIDED|95.0|-63.82|-37.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.72|-63.82|<0.0001
91718018|NCT02662569|183328428|SUPERIORITY||LS Mean Treatment Difference|-62.46|STANDARD_ERROR_OF_MEAN|24.64|<|0.0001|TWO_SIDED|95.0|-110.89|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-14.03|-110.89|<0.0001
91718019|NCT02662569|183328428|SUPERIORITY||LS Mean Treatment Difference|-45.32|STANDARD_ERROR_OF_MEAN|8.42|<|0.0001|TWO_SIDED|95.0|-61.87|-28.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-28.77|-61.87|<0.0001
91718020|NCT02662569|183328429|SUPERIORITY||LS Mean Treatment Difference|-18.02|STANDARD_ERROR_OF_MEAN|4.01||0.0002|TWO_SIDED|95.0|-25.89|-10.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-10.14|-25.89|0.0002
91718021|NCT02662569|183328429|SUPERIORITY||LS Mean Treatment Difference|-15.63|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-21.69|-9.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-9.58|-21.69|<0.0001
91718022|NCT02662569|183328430|SUPERIORITY||LS Mean Treatment Difference|-16.41|STANDARD_ERROR_OF_MEAN|14.18||0.0002|TWO_SIDED|95.0|-24.63|-8.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-8.19|-24.63|0.0002
91718023|NCT02662569|183328430|SUPERIORITY||LS Mean Treatment Difference|-12.31|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-18.76|-5.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-5.86|-18.76|<0.0001
91526816|NCT01355419|182929256|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|Regression, Linear|||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.||||<0.05
91718024|NCT02662569|183328431|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|1.52||0.0003|TWO_SIDED|95.0|3.36|9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.33|3.36|0.0003
91718025|NCT02662569|183328431|SUPERIORITY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|5.1|10.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||10.65|5.10|<0.0001
91526817|NCT02951351|182929257|NON_INFERIORITY|By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin.||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
91526818|NCT02951351|182929258|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91526819|NCT02951351|182929259|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
91680099|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||<|0.001|TWO_SIDED|95.0|3.35|5.25|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.25|3.35|<0.001
91680100|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|||<|0.001|TWO_SIDED|95.0|2.96|4.88|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.88|2.96|<0.001
91680101|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.268|TWO_SIDED|95.0|-0.29|1.05|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|-0.29|0.268
91680102|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|17.99|||<|0.001|TWO_SIDED|95.0|14.69|21.28|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.28|14.69|<0.001
91680103|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|||<|0.001|TWO_SIDED|95.0|1.57|6.17|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.17|1.57|<0.001
91680104|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|8.81|||<|0.001|TWO_SIDED|95.0|6.48|11.15|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||11.15|6.48|<0.001
91680105|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|14.12|||<|0.001|TWO_SIDED|95.0|10.83|17.4|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.40|10.83|<0.001
91680106|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|9.17|||<|0.001|TWO_SIDED|95.0|5.86|12.48|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|5.86|<0.001
91680107|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|4.94|||<|0.001|TWO_SIDED|95.0|2.62|7.27|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.27|2.62|<0.001
91680108|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|21.94|||<|0.001|TWO_SIDED|95.0|17.52|26.37|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.37|17.52|<0.001
91680109|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.002|TWO_SIDED|95.0|1.91|8.09|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.09|1.91|0.002
91680110|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|11.43|||<|0.001|TWO_SIDED|95.0|8.29|14.56|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.56|8.29|<0.001
91680111|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|16.94|||<|0.001|TWO_SIDED|95.0|12.53|21.36|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.36|12.53|<0.001
91680112|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|10.52|||<|0.001|TWO_SIDED|95.0|6.07|14.97|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.97|6.07|<0.001
91680113|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|6.43|||<|0.001|TWO_SIDED|95.0|3.3|9.55|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.55|3.30|<0.001
91680114|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|||<|0.001|TWO_SIDED|95.0|18.57|31.63|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||31.63|18.57|<0.001
91680115|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.023|TWO_SIDED|95.0|0.74|9.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.86|0.74|0.023
91680116|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|13.17|||<|0.001|TWO_SIDED|95.0|8.55|17.8|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.80|8.55|<0.001
91680117|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.28|26.31|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.31|13.28|<0.001
91680118|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|11.93|||<|0.001|TWO_SIDED|95.0|5.36|18.49|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.49|5.36|<0.001
91680119|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|7.87|||<|0.001|TWO_SIDED|95.0|3.27|12.48|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|3.27|<0.001
91680120|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|6.61|||<|0.001|TWO_SIDED|95.0|4.61|8.62|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.62|4.61|<0.001
91680121|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|1.74||||0.015|TWO_SIDED|95.0|0.34|3.14|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.14|0.34|0.015
91718026|NCT02662569|183328432|SUPERIORITY||LS Mean Treatment Difference|5.88|STANDARD_ERROR_OF_MEAN|1.72||0.0003|TWO_SIDED|95.0|2.49|9.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.27|2.49|0.0003
91718027|NCT02662569|183328432|SUPERIORITY||LS Mean Treatment Difference|8.14|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|5.03|11.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||11.25|5.03|<0.0001
91526820|NCT02951351|182929260|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91680122|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|2.92|5.76|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.76|2.92|<0.001
91680123|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|4.87|||<|0.001|TWO_SIDED|95.0|2.87|6.88|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.88|2.87|<0.001
91680124|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|2.27||||0.028|TWO_SIDED|95.0|0.25|4.28|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.28|0.25|0.028
91680125|NCT02912650|183251782|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|||<|0.001|TWO_SIDED|95.0|1.19|4.02|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.02|1.19|<0.001
91680126|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.56|||<|0.001|TWO_SIDED|95.0|-49.41|-23.71|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.71|-49.41|<0.001
91680127|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.95||||0.086|TWO_SIDED|95.0|-8.45|0.56|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.56|-8.45|0.086
91680128|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.71||||0.112|TWO_SIDED|95.0|-8.28|0.86|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.86|-8.28|0.112
91718028|NCT02662569|183328433|SUPERIORITY||LS Mean Treatment Difference|-27.18|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-34.2|-20.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-20.17|-34.20|<0.0001
91526821|NCT02951351|182929261|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91526822|NCT02951351|182929262|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91680129|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.52|||<|0.001|TWO_SIDED|95.0|-45.86|-19.17|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.17|-45.86|<0.001
91680130|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.88|||<|0.001|TWO_SIDED|95.0|-46.22|-19.55|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.55|-46.22|<0.001
91680131|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.11||||0.968|TWO_SIDED|95.0|-5.2|5.42|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.42|-5.20|0.968
91680132|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.88|||<|0.001|TWO_SIDED|95.0|-61.18|-34.58|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-34.58|-61.18|<0.001
91680133|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.023|TWO_SIDED|95.0|-11.61|-0.84|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.84|-11.61|0.023
91680134|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.026|TWO_SIDED|95.0|-11.73|-0.73|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.73|-11.73|0.026
91680135|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.51|||<|0.001|TWO_SIDED|95.0|-55.51|-27.52|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.52|-55.51|<0.001
91680136|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.77|||<|0.001|TWO_SIDED|95.0|-55.65|-27.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.89|-55.65|<0.001
91718029|NCT02662569|183328433|SUPERIORITY||LS Mean Treatment Difference|-24.01|STANDARD_ERROR_OF_MEAN|2.99|<|0.0001|TWO_SIDED|95.0|-29.88|-18.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-18.14|-29.88|<0.0001
91718030|NCT03154086|183328496|OTHER||Ratio|0.8||||0.204|TWO_SIDED|90.0|0.594|1.077|||ANOVA|||||1.077|0.5940|0.204
91718031|NCT03154086|183328497|OTHER||Ratio|0.7325||||0.118|TWO_SIDED|90.0|0.5267|1.019|||ANOVA|||||1.019|0.5267|0.118
91526823|NCT02951351|182929263|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91680137|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.16||||0.96|TWO_SIDED|95.0|-6.56|6.23|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.23|-6.56|0.960
91680138|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.73|||<|0.001|TWO_SIDED|95.0|-68.81|-42.65|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-42.65|-68.81|<0.001
91680139|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.16||||0.055|TWO_SIDED|95.0|-12.46|0.13|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.13|-12.46|0.055
91680140|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.7||||0.001|TWO_SIDED|95.0|-18.7|-4.7|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.70|-18.70|0.001
91680141|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-49.41|||<|0.001|TWO_SIDED|95.0|-63.21|-35.6|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-35.60|-63.21|<0.001
91680142|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-44.3|||<|0.001|TWO_SIDED|95.0|-58.04|-30.55|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-30.55|-58.04|<0.001
91718032|NCT03154086|183328498|OTHER||Ratio|0.6502||||0.157|TWO_SIDED|90.0|0.3876|1.091|||ANOVA|||||1.091|0.3876|0.157
91718033|NCT04465422|183328554|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|1.65|5.55|||Mixed Models Analysis|||Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.||5.55|1.65|<0.001
91526824|NCT02951351|182929264|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
91527583|NCT01976364|182930471|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.1|
91680143|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.69||||0.151|TWO_SIDED|95.0|-13.46|2.08|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.08|-13.46|0.151
91680144|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-56.94|||<|0.001|TWO_SIDED|95.0|-69.96|-43.91|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-43.91|-69.96|<0.001
91680145|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-9.0||||0.01|TWO_SIDED|95.0|-15.8|-2.19|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.19|-15.80|0.010
91680146|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.11|||<|0.001|TWO_SIDED|95.0|-27.97|-12.24|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.24|-27.97|<0.001
91680147|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.73|||<|0.001|TWO_SIDED|95.0|-61.64|-33.83|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.83|-61.64|<0.001
91680148|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-37.18|||<|0.001|TWO_SIDED|95.0|-50.96|-23.4|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.40|-50.96|<0.001
91718034|NCT04465422|183328554|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.019|TWO_SIDED|95.0|0.23|2.37|||Mixed Models Analysis|||Statistical Analysis 2 is based on Occupational Identity(range 11\~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)||2.37|0.23|0.019
91718035|NCT04465422|183328554|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.43||0.006|TWO_SIDED|95.0|0.38|2.11|||Mixed Models Analysis|||Statistical Analysis 3 is based on Occupational Competence(range 9\~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.||2.11|0.38|0.006
91718036|NCT04465422|183328554|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.38||0.136|TWO_SIDED|95.0|-0.19|1.35|||Mixed Models Analysis|||Statistical Analysis 4 is based on Occupational Behavior Settings(range 9\~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.||1.35|-0.19|0.136
91718037|NCT04465422|183328555|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.592|TWO_SIDED|95.0|-3.9|2.25|||Mixed Models Analysis|||Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0\~23；the higher scores indicate greater performance) total scores.||2.25|-3.90|0.592
91718038|NCT04465422|183328555|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.37||0.302|TWO_SIDED|95.0|-2.29|7.23|||Mixed Models Analysis|||Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20\~100；the higher scores indicate greater performance) total scores.||7.23|-2.29|0.302
91718039|NCT04465422|183328555|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.25||0.931|TWO_SIDED|95.0|-6.25|6.82|||Mixed Models Analysis|||Statistical Analysis 3 is based on Personal and Social Performance scale (range 1\~100；the higher scores indicate greater performance) total scores.||6.82|-6.25|0.931
91718040|NCT04465422|183328555|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.85||0.981|TWO_SIDED|95.0|-1.73|1.69|||Mixed Models Analysis|||Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1\~10；the higher scores indicate greater performance) total scores.||1.69|-1.73|0.981
91718041|NCT00572832|183328619|NON_INFERIORITY_OR_EQUIVALENCE|The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /\[log (RGMC) -δ0\] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.||||||0.025||95.0||||Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,\& 18.|ANOVA|Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||||.025
91718042|NCT01041859|183328665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.234|<|0.001|TWO_SIDED|95.0|-1.415|-0.493||Analysis of covariance (ANCOVA) model was used with treatment, dose level, and pooled analysis center as factors and baseline pain intensity score as a covariate|ANCOVA||Mean Difference is least squares mean change in DB Tapentadol ER group minus least squares mean change in DB Placebo group (based on ANCOVA model)|The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 1.0 with an SD of 2.6, 144 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a DB treatment group for the study was 300.||-0.493|-1.415|<0.001
91718043|NCT02753881|183328704|OTHER|||||||0.036||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicin.||||.036
91718044|NCT02753881|183328704|OTHER|||||||0.002||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicinol.||||0.002
91718045|NCT02753881|183328706|OTHER|||||||0.023||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicin.||||0.023
91718046|NCT02753881|183328706|OTHER|||||||0.041||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicinol.||||0.041
91718047|NCT05471505|183328780|OTHER||Hazard Ratio (HR)|0.752|||<|0.001|TWO_SIDED|95.0|0.719|0.787|||COX Proportional Hazards Regression|||||0.787|0.719|<0.001
91718048|NCT05471505|183328781|OTHER||Hazard Ratio (HR)|0.747|||<|0.001|TWO_SIDED|95.0|0.687|0.813|||COX Proportional Hazards Regression|||||0.813|0.687|<0.001
91718049|NCT05471505|183328782|OTHER||Hazard Ratio (HR)|0.909|||<|0.001|TWO_SIDED|95.0|0.862|0.958|||COX Proportional Hazards Regression|||||0.958|0.862|<0.001
91718050|NCT05471505|183328783|OTHER||Hazard Ratio (HR)|0.948||||0.378|TWO_SIDED|95.0|0.842|1.067|||COX Proportional Hazards Regression|||||1.067|0.842|0.378
91718051|NCT05471505|183328784|OTHER||Hazard Ratio (HR)|0.259|||<|0.001|TWO_SIDED|95.0|0.229|0.294|||COX Proportional Hazards Regression|||||0.294|0.229|<0.001
91718052|NCT05471505|183328785|OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.7|0.84|||COX Proportional Hazards Regression|||||0.840|0.700|<0.001
91718053|NCT05471505|183328786|OTHER||Hazard Ratio (HR)|0.932||||0.022|TWO_SIDED|95.0|0.877|0.99|||COX Proportional Hazards Regression|||||0.990|0.877|0.022
91718054|NCT03427892|183328807|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
91718055|NCT03427892|183328808|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.93||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.93
91718056|NCT03427892|183328809|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.49||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is RAVLT Score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.49
91718057|NCT03427892|183328809|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.56||||||Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.Reported is delay score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.56
91718058|NCT03427892|183328810|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.221||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. Reported is CW score.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.221
91718059|NCT03427892|183328810|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.306||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.Reported is Inter. score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.306
91718060|NCT03427892|183328811|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.07||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is TMT A.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.07
91722501|NCT06001021|183337811|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|86.89|STANDARD_DEVIATION|45.43||0|TWO_SIDED|90.0|78.33|95.46||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||95.46|78.33|0.00
91680149|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.19||||0.013|TWO_SIDED|95.0|-20.02|-2.36|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.36|-20.02|0.013
91680150|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-58.14|||<|0.001|TWO_SIDED|95.0|-71.03|-45.26|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-45.26|-71.03|<0.001
91680151|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.15||||0.005|TWO_SIDED|95.0|-17.24|-3.06|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.06|-17.24|0.005
91680152|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.77|||<|0.001|TWO_SIDED|95.0|-35.1|-18.44|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-18.44|-35.10|<0.001
91680153|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.74|||<|0.001|TWO_SIDED|95.0|-61.76|-33.72|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.72|-61.76|<0.001
91680154|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-31.69|||<|0.001|TWO_SIDED|95.0|-45.61|-17.76|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.76|-45.61|<0.001
91680155|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.76|||<|0.001|TWO_SIDED|95.0|-26.1|-7.42|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.42|-26.10|<0.001
91680156|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
91680157|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
91680158|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
91680159|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
91680160|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
91680161|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
91680162|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-52.9|||<|0.001|TWO_SIDED|95.0|-66.06|-39.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-39.75|-66.06|<0.001
91680163|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.93||||0.042|TWO_SIDED|95.0|-17.53|-0.34|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.34|-17.53|0.042
91680164|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.25|||<|0.001|TWO_SIDED|95.0|-36.65|-17.86|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.86|-36.65|<0.001
91680165|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-43.78|||<|0.001|TWO_SIDED|95.0|-57.83|-29.72|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-29.72|-57.83|<0.001
91680166|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-25.75|||<|0.001|TWO_SIDED|95.0|-39.93|-11.57|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-11.57|-39.93|<0.001
91680167|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.49|||<|0.001|TWO_SIDED|95.0|-28.39|-8.59|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-8.59|-28.39|<0.001
91680168|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
91680169|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
91680170|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
91680171|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
91680172|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
91680173|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
91680174|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-34.21|||<|0.001|TWO_SIDED|95.0|-48.21|-20.21|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-20.21|-48.21|<0.001
91680175|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.97||||0.179|TWO_SIDED|95.0|-17.12|3.19|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.19|-17.12|0.179
91680176|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.7|||<|0.001|TWO_SIDED|95.0|-31.04|-10.35|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-10.35|-31.04|<0.001
91680177|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.2|||<|0.001|TWO_SIDED|95.0|-41.44|-12.96|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.96|-41.44|<0.001
91680178|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.9||||0.051|TWO_SIDED|95.0|-27.84|0.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.04|-27.84|0.051
91680179|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.76||||0.01|TWO_SIDED|95.0|-24.21|-3.31|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.31|-24.21|0.010
91680180|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-23.25||||0.001|TWO_SIDED|95.0|-37.31|-9.2|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-9.20|-37.31|0.001
91680181|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-2.22||||0.676|TWO_SIDED|95.0|-12.63|8.19|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.19|-12.63|0.676
91680182|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.15||||0.013|TWO_SIDED|95.0|-23.57|-2.74|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.74|-23.57|0.013
91680183|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.94||||0.004|TWO_SIDED|95.0|-35.18|-6.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-6.69|-35.18|0.004
91680184|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.39||||0.14|TWO_SIDED|95.0|-24.19|3.4|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.40|-24.19|0.140
91680185|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.06||||0.038|TWO_SIDED|95.0|-21.51|-0.61|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.61|-21.51|0.038
91680186|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-17.9||||0.013||95.0|-32.13|-3.79|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-3.79|-32.13|0.013
91680187|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.85||||0.467||95.0|-14.23|6.53|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.53|-14.23|0.467
91680188|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.38||||0.049||95.0|-20.73|-0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.02|-20.73|0.049
91680189|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-14.1||||0.05||95.0|-28.22|0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.02|-28.22|0.050
91680190|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.99||||0.255||95.0|-21.73|5.76|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||5.76|-21.73|0.255
91680191|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.57||||0.212||95.0|-16.89|3.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.75|-16.89|0.212
91680192|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-15.68||||0.027||95.0|-29.59|-1.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-1.77|-29.59|0.027
91718061|NCT03427892|183328811|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.19||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.The above reported is TMT B.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.19
91680193|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-4.39||||0.399|TWO_SIDED|95.0|-14.59|5.82|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.82|-14.59|0.399
91680194|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.5||||0.152||95.0|-17.76|2.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.77|-17.76|0.152
91680195|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.32||||0.106|TWO_SIDED|95.0|-25.05|2.4|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.40|-25.05|0.106
91680196|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.59||||0.21||95.0|-22.0|4.83|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.83|-22.00|0.210
91680197|NCT02912650|183251783|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.13||||0.545||95.0|-13.26|7.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||7.00|-13.26|0.545
91680198|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|20.74|||<|0.001|TWO_SIDED|95.0|10.54|30.94|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||30.94|10.54|<0.001
91680199|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.52||||0.342|TWO_SIDED|95.0|-4.81|13.86|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.86|-4.81|0.342
91680200|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.62||||0.459|TWO_SIDED|95.0|-5.98|13.22|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.22|-5.98|0.459
91680201|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.2||||0.001|TWO_SIDED|95.0|6.24|26.17|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||26.17|6.24|0.001
91680202|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|17.37|||<|0.001|TWO_SIDED|95.0|7.42|27.31|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.31|7.42|<0.001
91680203|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.91||||0.849|TWO_SIDED|95.0|-10.2|8.42|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.42|-10.2|0.849
91680204|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.08|||<|0.001|TWO_SIDED|95.0|39.53|62.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||62.62|39.53|<0.001
91680205|NCT02912650|183251784|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|5.16||||0.318|TWO_SIDED|95.0|-4.97|15.3|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.30|-4.97|0.318
91680206|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.062|TWO_SIDED|95.0|-0.49|20.21|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.21|-0.49|0.062
91526825|NCT00474175|182929274|SUPERIORITY_OR_OTHER||Treatment difference|16.46|||<|0.001|TWO_SIDED|95.0|7.2|25.7||Alternative hypotheses tested in the study was that benzocaine 20% was significantly (p less than or equal to \[=\<\] 0.05) more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and its associated confidence interval (C.I.) was calculated based on CMH weighted percentages and the corresponding standard error.||25.7|7.2|<0.001
91680207|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.6|||<|0.001|TWO_SIDED|95.0|33.45|57.76|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.76|33.45|<0.001
91680208|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|41.07|||<|0.001|TWO_SIDED|95.0|28.76|53.38|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||53.38|28.76|<0.001
91680209|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.74||||0.374|TWO_SIDED|95.0|-5.7|15.17|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.17|-5.70|0.374
91680210|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.09|||<|0.001|TWO_SIDED|95.0|47.93|72.26|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.26|47.93|<0.001
91680211|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.3||||0.323|TWO_SIDED|95.0|-4.22|12.81|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.81|-4.22|0.323
91680212|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.032|TWO_SIDED|95.0|0.86|18.86|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.86|0.86|0.032
91680213|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.66|||<|0.001|TWO_SIDED|95.0|43.11|68.2|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||68.20|43.11|<0.001
91680214|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.38|||<|0.001|TWO_SIDED|95.0|37.71|63.05|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.05|37.71|<0.001
91680215|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.61||||0.232|TWO_SIDED|95.0|-3.58|14.8|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.80|-3.58|0.232
91680216|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.92|||<|0.001|TWO_SIDED|95.0|47.39|72.46|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.46|47.39|<0.001
91680217|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.51||||0.179|TWO_SIDED|95.0|-2.52|13.53|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.53|-2.52|0.179
91680218|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.37||||0.003|TWO_SIDED|95.0|4.65|22.1|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.10|4.65|0.003
91680219|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
91680220|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
91680221|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680222|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.51|||<|0.001|TWO_SIDED|95.0|47.99|73.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||73.03|47.99|<0.001
91680223|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.08||||0.135|TWO_SIDED|95.0|-1.89|14.05|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.89|0.135
91680224|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.97||||0.002|TWO_SIDED|95.0|5.3|22.64|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.64|5.30|0.002
91526826|NCT00474175|182929274|SUPERIORITY_OR_OTHER||Treatment difference|9.8||||0.038|TWO_SIDED|95.0|0.3|19.3||Alternative hypotheses tested in the study was that benzocaine 10% was significantly (p=\<0.05) more effective than placebo provided that benzocaine 20% was more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||19.3|0.3|0.038
91526827|NCT00474175|182929274|SUPERIORITY_OR_OTHER||Treatment difference|6.72||||0.047|TWO_SIDED|95.0|0.2|13.3|||Cochran-Mantel-Haenszel|Dose response was considered established if the percentage of responders between the 20% and 10% was greater than or equal to 5%.||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||13.3|0.2|0.047
91680225|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
91680226|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
91680227|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680228|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680229|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680230|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680231|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91526828|NCT00474175|182929275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.55|2.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. Hazard Ratio (HR) of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.64|1.55|<0.001
91680232|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680233|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680234|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680235|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680236|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680237|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680238|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680239|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680240|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680241|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680242|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680243|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680244|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91526829|NCT00474175|182929275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.12||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.12|1.26|<0.001
91680245|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680246|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680247|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680248|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680249|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91527584|NCT01976364|182930471|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.0|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|0.0|
91680250|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680251|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680252|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680253|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680254|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680255|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680256|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680257|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680258|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680259|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680260|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680261|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680262|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|< 0.001
91680263|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680264|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001||95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.00|45.24|< 0.001
91680265|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680266|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|< 0.001
91680267|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||64.09|37.39|<0.001
91680268|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680269|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||16.97|-1.15|0.087
91680270|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680271|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680272|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680273|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91718062|NCT03427892|183328812|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
91718063|NCT03427892|183328813|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.022||||||To analyze separate one-way repeated measures analyses of variance (ANOVA) were performed. Time (baseline, week 4, week 8) was included as the within-subject factor.Above is from baseline to week 8 for C-SSRS AA, IA, and ABA.|ANOVA|One-way repeated measures (ANOVA) were performed. Time (baseline, wk 4, wk 8) included as within-subject factor. Above is for C-SSRS AA,IA, and ABA.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.022
91718064|NCT03427892|183328813|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.163||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.163
91680274|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680275|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91718065|NCT03427892|183328814|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.133||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.133
91680276|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680277|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680278|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680279|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680280|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680281|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680282|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
91680283|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
91680284|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
91680285|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680286|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680287|NCT02912650|183251784|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680288|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.156|TWO_SIDED|95.0|-0.44|2.75|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.75|-0.44|0.156
91680289|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.155|TWO_SIDED|95.0|-0.44|2.76|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.76|-0.44|0.155
91680290|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.68||||0.605|TWO_SIDED|95.0|-3.27|1.9|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||1.90|-3.27|0.605
91680291|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.84||||0.079|TWO_SIDED|95.0|-0.21|3.89|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.89|-0.21|0.079
91718066|NCT03427892|183328815|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
91718067|NCT03427892|183328816|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
91718068|NCT03427892|183328817|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.005||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.005
91718069|NCT03427892|183328818|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
91718070|NCT03427892|183328819|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.295||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.295
91718071|NCT01287936|183328909|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed Rank test|||||||<0.001
91718072|NCT01287936|183328911|SUPERIORITY|||||||0.004|||||||Wilcoxon Signed Rank test|||||||0.004
91718073|NCT00427934|183328921|SUPERIORITY_OR_OTHER||Percentage Difference|-1.73||||0.79||90.0|-15.13|8.68|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||8.68|-15.13|0.790
91526830|NCT00474175|182929275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.03|TWO_SIDED|95.0|1.02|1.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.51|1.02|0.030
91718074|NCT00427934|183328921|SUPERIORITY_OR_OTHER||Percentage Difference|0.43||||0.477||90.0|-13.67|11.64|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||11.64|-13.67|0.477
91718075|NCT00427934|183328921|SUPERIORITY_OR_OTHER||Percentage Difference|3.03||||0.37||90.0|-12.85|16.77|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||16.77|-12.85|0.370
91718076|NCT00427934|183328921|SUPERIORITY_OR_OTHER||Percentage Difference|8.66||||0.175||90.0|-7.07|22.03|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||22.03|-7.07|0.175
91526831|NCT00474175|182929276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04|||<|0.001|TWO_SIDED|95.0|1.57|2.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.66|1.57|<0.001
91680292|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-1.85||||0.078|TWO_SIDED|95.0|-3.9|0.21|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.21|-3.90|0.078
91680293|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.47|||<|0.001|TWO_SIDED|95.0|15.33|27.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.62|15.33|<0.001
91680294|NCT02912650|183251785|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|7.79||||0.056|TWO_SIDED|95.0|-0.19|15.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.77|-0.19|0.056
91680295|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.37||||0.934|TWO_SIDED|95.0|-9.18|8.43|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.43|-9.18|0.934
91680296|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.67|||<|0.001|TWO_SIDED|95.0|8.58|18.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.77|8.58|<0.001
91680297|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.96|||<|0.001|TWO_SIDED|95.0|15.64|28.28|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||28.28|15.64|<0.001
91680298|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.21||||0.05|TWO_SIDED|95.0|-16.4|-0.01|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.01|-16.40|0.050
91680299|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.89|||<|0.001|TWO_SIDED|95.0|47.05|64.73|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.73|47.05|<0.001
91680300|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|12.99||||0.015|TWO_SIDED|95.0|2.5|23.49|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.49|2.50|0.015
91680301|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.16||||0.188|TWO_SIDED|95.0|-3.51|17.82|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.82|-3.51|0.188
91680302|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.61|||<|0.001|TWO_SIDED|95.0|33.85|51.38|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||51.38|33.85|<0.001
91680303|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.58|||<|0.001|TWO_SIDED|95.0|39.63|57.54|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.54|39.63|<0.001
91526832|NCT00474175|182929276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73|||<|0.001|TWO_SIDED|95.0|1.34|2.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.25|1.34|<0.001
91680304|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.98||||0.266|TWO_SIDED|95.0|-16.51|4.55|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.55|-16.51|0.266
91680305|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.77|||<|0.001|TWO_SIDED|95.0|49.63|69.9|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.90|49.63|<0.001
91680306|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.62||||0.094|TWO_SIDED|95.0|-1.46|18.69|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.69|-1.46|0.094
91718077|NCT00427934|183328922|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.42||90.0|-6.34|6.01|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||6.01|-6.34|0.420
91718078|NCT00427934|183328922|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||7.95|-5.08|0.258
91718079|NCT00427934|183328922|SUPERIORITY_OR_OTHER||Percentage Difference|-3.46||||1||90.0|-14.39|3.42|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||3.42|-14.39|1.000
91718080|NCT00427934|183328922|SUPERIORITY_OR_OTHER||Percentage Difference|-1.3||||0.899||90.0|-13.56|7.92|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.92|-13.56|0.899
91718081|NCT00427934|183328922|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.489||90.0|-11.24|10.96|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||10.96|-11.24|0.489
91718082|NCT00427934|183328923|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||1.28|-13.59|1.000
91718083|NCT00427934|183328923|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.95|-5.08|0.258
91526833|NCT00474175|182929276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.1|TWO_SIDED|95.0|0.97|1.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.43|0.97|0.100
91527585|NCT01976364|182930471|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|0.1|
91718084|NCT00427934|183328923|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||1.28|-13.59|1.000
91718085|NCT00427934|183328924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.335||90.0|-0.79|2.99||This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.99|-0.79|0.335
91718086|NCT00427934|183328924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.816||90.0|-1.82|2.41||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.41|-1.82|0.816
91718087|NCT00427934|183328924|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.996||90.0|-2.35|2.36||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||2.36|-2.35|0.996
91718088|NCT00427934|183328924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.263||90.0|-3.98|0.76||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.76|-3.98|0.263
91718089|NCT00427934|183328924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.294||90.0|-3.82|0.85||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.85|-3.82|0.294
91718090|NCT00427934|183328925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7||90.0|-1.7|1.06||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||1.06|-1.70|0.700
91718091|NCT00427934|183328925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.799||90.0|-1.45|1.97||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||1.97|-1.45|0.799
91718092|NCT00427934|183328925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.867||90.0|-1.35|1.66||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||1.66|-1.35|0.867
91680307|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.43||||0.047|TWO_SIDED|95.0|0.15|20.72|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.72|0.15|0.047
91718093|NCT00427934|183328925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.167||90.0|-3.17|0.28||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.28|-3.17|0.167
91680308|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.95|||<|0.001|TWO_SIDED|95.0|40.5|61.4|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.40|40.50|<0.001
91680309|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.34|||<|0.001|TWO_SIDED|95.0|38.79|59.89|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.89|38.79|<0.001
91680310|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.79||||0.734|TWO_SIDED|95.0|-8.56|12.14|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.14|-8.56|0.734
91680311|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.46|||<|0.001|TWO_SIDED|95.0|46.88|70.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.03|46.88|<0.001
91680312|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.01||||0.152|TWO_SIDED|95.0|-2.57|16.59|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.59|-2.57|0.152
91680313|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.0||||0.073|TWO_SIDED|95.0|-0.83|19.82|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||19.82|-0.83|0.073
91680314|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.3|||<|0.001|TWO_SIDED|95.0|39.38|63.21|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.21|39.38|<0.001
91680315|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.49|||<|0.001|TWO_SIDED|95.0|37.5|61.47|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.47|37.50|<0.001
91680316|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.99||||0.694|TWO_SIDED|95.0|-7.91|11.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||11.89|-7.91|0.694
91680317|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.61|||<|0.001|TWO_SIDED|95.0|48.37|72.84|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.84|48.37|<0.001
91718094|NCT00427934|183328925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.966||90.0|-1.91|1.81||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.81|-1.91|0.966
91527586|NCT01976364|182930471|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.1|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.1|
91680318|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.58||||0.135|TWO_SIDED|95.0|-2.05|15.2|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.20|-2.05|0.135
91680319|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|14.74||||0.002|TWO_SIDED|95.0|5.5|23.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|5.50|0.002
91680320|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.82|||<|0.001|TWO_SIDED|95.0|41.31|66.32|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.32|41.31|<0.001
91680321|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.93|||<|0.001|TWO_SIDED|95.0|33.21|58.66|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.66|33.21|<0.001
91718095|NCT00427934|183328926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.925||90.0|-6.41|5.72||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||5.72|-6.41|0.925
91718096|NCT00427934|183328926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.26||||0.239||90.0|-12.62|2.11||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.11|-12.62|0.239
91718097|NCT00427934|183328926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.872||90.0|-6.79|8.25||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||8.25|-6.79|0.872
91718098|NCT00427934|183328926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.745||90.0|-9.91|6.65||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||6.65|-9.91|0.745
91718099|NCT00427934|183328926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.644||90.0|-10.14|5.71||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||5.71|-10.14|0.644
91718100|NCT00427934|183328927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.524||90.0|-8.49|3.77||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||3.77|-8.49|0.524
91718101|NCT00427934|183328927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.96||||0.338||90.0|-10.8|2.87||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.87|-10.80|0.338
91718102|NCT00427934|183328927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.83||90.0|-8.55|6.58||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||6.58|-8.55|0.830
91718103|NCT00427934|183328927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68||||0.118||90.0|-15.76|0.4||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.40|-15.76|0.118
91718104|NCT00427934|183328927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.712||90.0|-9.73|6.18||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.18|-9.73|0.712
91718105|NCT00427934|183328928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.54||90.0|-0.28|0.13||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.13|-0.28|0.540
91680322|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.18||||0.091|TWO_SIDED|95.0|-1.32|17.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.69|-1.32|0.091
91718106|NCT00427934|183328928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.757||90.0|-0.28|0.19||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||0.19|-0.28|0.757
91718107|NCT00427934|183328928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.767||90.0|-0.31|0.21||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.21|-0.31|0.767
91680323|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.0|||<|0.001|TWO_SIDED|95.0|47.59|72.42|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.42|47.59|<0.001
91680324|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.03||||0.159|TWO_SIDED|95.0|-2.36|14.43|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.43|-2.36|0.159
91718108|NCT00427934|183328928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.112||90.0|-0.52|0.01||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.01|-0.52|0.112
91718109|NCT00427934|183328928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.49||90.0|-0.42|0.17||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.17|-0.42|0.490
91718110|NCT00427934|183328929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.464||90.0|-0.19|0.07||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.07|-0.19|0.464
91718111|NCT00427934|183328929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.068||90.0|-0.35|-0.02||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||-0.02|-0.35|0.068
91718112|NCT00427934|183328929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.532||90.0|-0.23|0.11||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.11|-0.23|0.532
91718113|NCT00427934|183328929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.063||90.0|-0.41|-0.03||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||-0.03|-0.41|0.063
91718114|NCT00427934|183328929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.396||90.0|-0.36|0.12||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.12|-0.36|0.396
91718115|NCT00427934|183328930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.481||90.0|-7.36|2.96||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.96|-7.36|0.481
91718116|NCT00427934|183328930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.698||90.0|-4.34|6.99||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||6.99|-4.34|0.698
91680325|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.32|||<|0.001|TWO_SIDED|95.0|6.23|24.41|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.41|6.23|<0.001
91680326|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.79|||<|0.001|TWO_SIDED|95.0|41.08|66.5|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.50|41.08|<0.001
91680327|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.76|||<|0.001|TWO_SIDED|95.0|31.72|57.81|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.81|31.72|<0.001
91680328|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.28||||0.052|TWO_SIDED|95.0|-0.08|18.64|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.64|-0.08|0.052
91680329|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.57|||<|0.001|TWO_SIDED|95.0|44.75|70.39|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.39|44.75|<0.001
91680330|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.06||||0.147|TWO_SIDED|95.0|-2.13|14.25|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.25|-2.13|0.147
91680331|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.3|||<|0.001|TWO_SIDED|95.0|6.39|24.21|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.21|6.39|<0.001
91680332|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.32|||<|0.001|TWO_SIDED|95.0|38.16|64.48|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.48|38.16|<0.001
91680333|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.28|||<|0.001|TWO_SIDED|95.0|28.74|55.82|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||55.82|28.74|<0.001
91680334|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.27||||0.049|TWO_SIDED|95.0|0.04|18.49|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.49|0.04|0.049
91680335|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
91680336|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
91680337|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
91680338|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
91680339|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
91680340|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
91680341|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
91680342|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
91680343|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
91680344|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
91680345|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
91680346|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
91680347|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.49|45.93|<0.001
91718117|NCT00427934|183328930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.233||90.0|-1.79|11.1||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||11.10|-1.79|0.233
91718118|NCT00427934|183328930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48||||0.32||90.0|-2.29|9.25||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||9.25|-2.29|0.320
91718119|NCT00427934|183328930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.912||90.0|-5.81|6.64||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.64|-5.81|0.912
91718120|NCT00427934|183328931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.653||90.0|-0.31|0.18||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 1||0.18|-0.31|0.653
91718121|NCT00427934|183328931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.703||90.0|-0.41|0.26||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 2||0.26|-0.41|0.703
91718122|NCT00427934|183328931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.968||90.0|-0.37|0.39||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 4||0.39|-0.37|0.968
91718123|NCT00427934|183328931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.21||90.0|-0.72|0.1||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 8||0.10|-0.72|0.210
91718124|NCT00427934|183328931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.696||90.0|-0.53|0.33||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 12||0.33|-0.53|0.696
91718125|NCT00427934|183328933|SUPERIORITY_OR_OTHER||Percentage Difference|9.09||||0.155||90.0|-6.16|21.83||p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were \< 5 otherwise Pearson chi-square test.|Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|||21.83|-6.16|0.155
91527587|NCT01976364|182930472|OTHER||LS mean difference|-19.43|||||TWO_SIDED|95.0|-58.06|19.21||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||19.21|-58.06|
91718126|NCT00427934|183328939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.698||90.0|-1.87|3.01||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||3.01|-1.87|0.698
91718127|NCT00427934|183328939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68||||0.344||90.0|-4.62|1.26||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.26|-4.62|0.344
91718128|NCT00427934|183328940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.734||90.0|-2.71|4.11||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||4.11|-2.71|0.734
91718129|NCT00427934|183328940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.818||90.0|-3.5|4.62||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||4.62|-3.50|0.818
91718130|NCT00427934|183328941|SUPERIORITY_OR_OTHER|||||||0.649||95.0|||||Fisher Exact|||||||0.649
91718131|NCT00427934|183328942|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Log Rank|||||||0.9826
91718132|NCT02683109|183328952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the Tio+Olo FDC versus the Tio/Olo free combination was tested at the one-sided α-level of 0.025 using a non-inferiority margin of 0.1 L.|Adjusted mean|0.024|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|-0.02|0.067|||ANCOVA|||The primary analysis was conducted using an Analysis of Covariance \[ANCOVA\] model including treatment as fixed categorical effect and baseline as continuous covariate.||0.067|-0.020|<0.0001
91718133|NCT02683109|183328953|SUPERIORITY_OR_OTHER||Adjusted mean|0.006|STANDARD_ERROR_OF_MEAN|0.034||0.8648|TWO_SIDED|95.0|-0.061|0.073|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.073|-0.061|0.8648
91718134|NCT02683109|183328954|SUPERIORITY_OR_OTHER||Adjusted mean|-0.327|STANDARD_ERROR_OF_MEAN|0.536||0.542|TWO_SIDED|95.0|-1.384|0.729|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.729|-1.384|0.5420
91718135|NCT00368251|183328955|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.15|||=|0.942|TWO_SIDED|95.0|-26.12|24.96||All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo was calculated.|"The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.~The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.~The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power."||24.96|-26.12|=0.942
91718136|NCT00368251|183328955|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|-18.05|||=|0.105|TWO_SIDED|95.0|-39.31|4.86||Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||4.86|-39.31|=0.105
91718137|NCT00368251|183328956|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|1.24|||=|0.672|TWO_SIDED|95.0|-21.9|31.06||Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).|Difference versus Placebo.|If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.||31.06|-21.90|=0.672
91718138|NCT00368251|183328956|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.806|TWO_SIDED|95.0|-33.33|18.75||Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|"In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:~* Functional Disability~* Stimulus Sensitivity~* Myoclonus Patient Questionnaire"||18.75|-33.33|=0.806
91718139|NCT00368251|183328957|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.549|TWO_SIDED|95.0|-25.0|100.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Willcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||100.00|-25.00|=0.549
91718140|NCT00368251|183328957|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.654|TWO_SIDED|95.0|-50.0|66.67||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||66.67|-50.00|=0.654
91718141|NCT00368251|183328958|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|14.29|||=|0.037|TWO_SIDED|95.0|-1.76|39.39||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||39.39|-1.76|=0.037
91718142|NCT00368251|183328958|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|10.0|||=|0.111|TWO_SIDED|95.0|-5.56|30.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||30.00|-5.56|=0.111
91718143|NCT00368251|183328959|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||||||=0.931
91718144|NCT00368251|183328959|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.253||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||P-value for pairwise comparison of each Brivaracetam dose versus Placebo.||||=0.253
91526834|NCT00474175|182929278|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.035|TWO_SIDED|95.0|0.03|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using Analysis of Variance (ANOVA) which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|0.03|0.035
91718145|NCT02202252|183329001|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.490
91718146|NCT02202252|183329002|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
91718147|NCT02202252|183329003|SUPERIORITY_OR_OTHER|||||||0.819|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.819
91718148|NCT02111083|183329053|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.965|1.01||||||||1.01|0.965|
91718149|NCT02111083|183329054|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.872|||||TWO_SIDED|90.0|0.828|0.919||||||||0.919|0.828|
91718150|NCT02111083|183329055|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|0.0|0.375||||||||0.375|0|
91718151|NCT02111083|183329056|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.954|1.02||||||||1.02|0.954|
91680348|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||14.67|-1.38|0.105
91680349|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.23|||<|0.001|TWO_SIDED|95.0|6.48|23.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|6.48|<0.001
91680350|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001||95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
91680351|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.61|||<|0.001|TWO_SIDED|95.0|30.15|57.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.07|30.15|<0.001
91680352|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.61||||0.065|TWO_SIDED|95.0|-0.55|17.76|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.76|-0.55|0.065
91680353|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
91680354|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
91680355|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
91680356|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
91680357|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.89|||<|0.001||95.0|31.51|58.26|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.26|31.51|<0.001
91680358|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.36||||0.113|TWO_SIDED|95.0|-1.73|16.45|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.45|-1.73|0.113
91680359|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
91680360|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
91680361|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
91680362|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680363|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680364|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680365|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
91680366|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
91718152|NCT02111083|183329057|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.95|||||TWO_SIDED|90.0|0.901|1.0||||||||1.00|0.901|
91680367|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
91680368|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680369|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680370|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680371|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
91680372|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
91680373|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
91680374|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
91680375|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
91680376|NCT02912650|183251785|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
91680377|NCT02912650|183251786|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
91680378|NCT02912650|183251786|SUPERIORITY_OR_OTHER|||||||0.004|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.004
91680379|NCT02912650|183251786|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
91680380|NCT02912650|183251786|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
91680381|NCT02912650|183251786|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
91680382|NCT02912650|183251786|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.003
91680383|NCT01674647|183251790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.15|1.73|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.73|0.15|
91680384|NCT01674647|183251791|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.21|2.67|||no test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.26% - 1.27%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.80% (0.27% - 2.00%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.67|0.21|
91680385|NCT01674647|183251792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.06|2.0|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.20% (0.04% - 0.71%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.00|0.06|
91680386|NCT01674647|183251793|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.16|1.55|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.27% - 1.29%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.22% (0.53% - 2.51%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.55|0.16|
91718153|NCT02111083|183329058|SUPERIORITY_OR_OTHER||Difference of least squares means|0.424|||||TWO_SIDED|90.0|0.164|0.685||||||||0.685|0.164|
91718154|NCT02111083|183329059|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.992|||||TWO_SIDED|90.0|0.975|1.01||||||||1.01|0.975|
91718155|NCT00447083|183329069|OTHER|||||||0.1811|||||||t-test, 2 sided|||||||.1811
91718156|NCT03363906|183329080|SUPERIORITY||Ratio Geometric Least Squares (LS) Mean|1.04||||0.473|TWO_SIDED|90.0|0.949|1.14|||Mixed Models Analysis|||||1.14|0.949|0.473
91718157|NCT03363906|183329081|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.119|TWO_SIDED|90.0|0.993|1.3|||ANOVA|||||1.30|0.993|0.119
91718158|NCT00676143|183329082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.979|TWO_SIDED|95.0|-1.18|1.22||Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||1.22|-1.18|0.979
91718159|NCT00676143|183329083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.973|TWO_SIDED|95.0|-2.51|2.6||Primary variable DAD total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||2.60|-2.51|0.973
91718160|NCT00676143|183329084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.159|TWO_SIDED|95.0|-0.17|0.03|||Mixed Models Analysis|||"Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||0.03|-0.17|0.159
91718161|NCT00676143|183329085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.62|TWO_SIDED|95.0|-6.89|4.13|||ANCOVA|||Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.||4.13|-6.89|0.620
91718162|NCT00676143|183329086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.884|TWO_SIDED|95.0|-1.89|1.63|||Mixed Models Analysis|||"Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||1.63|-1.89|0.884
91718163|NCT00676143|183329087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.7|TWO_SIDED|95.0|-0.97|1.45|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||1.45|-0.97|0.700
91527588|NCT01976364|182930472|OTHER||LS mean difference|-30.11|||||TWO_SIDED|95.0|-83.58|23.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||23.37|-83.58|
91680387|NCT01674647|183251798|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.18|5.47|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.41% (0.14% - 1.02%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.41% (0.07% - 1.41%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||5.47|0.18|
91680388|NCT01674647|183251799|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.2|3.49|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||3.49|0.20|
91680389|NCT03923530|183251812|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.12
91680390|NCT03923530|183251813|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.49
91680391|NCT03923530|183251814|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.03
91680392|NCT03923530|183251815|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.27
91718164|NCT00676143|183329088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.949|TWO_SIDED|95.0|-2.61|2.78|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||2.78|-2.61|0.949
91718165|NCT00676143|183329089|SUPERIORITY_OR_OTHER|||||||0.684|||||||Log Rank|||||||0.684
91718166|NCT00676143|183329090|SUPERIORITY_OR_OTHER|||||||0.383|||||||Log Rank|||||||0.383
91718167|NCT00676143|183329091|SUPERIORITY_OR_OTHER|||||||0.191|||||||Log Rank|||||||0.191
91718168|NCT00676143|183329092|SUPERIORITY_OR_OTHER|||||||0.478|||||||Log Rank|||||||0.478
91718169|NCT00676143|183329093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.462|TWO_SIDED|95.0|-0.41|0.13|||Mixed Models Analysis|||Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.13|-0.41|0.462
91680393|NCT03923530|183251816|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.18
91680394|NCT03923530|183251817|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.8
91680395|NCT03923530|183251818|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.76
91680396|NCT00741936|183251819|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
91680397|NCT00741936|183251820|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
91718170|NCT00676143|183329095|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.086
91718171|NCT00676143|183329097|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.120
91718172|NCT00676143|183329098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.448|TWO_SIDED|95.0|-0.55|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.24|-0.55|0.448
91718173|NCT00250588|183329123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.05|TWO_SIDED|95.0|0.63|7.4||Bonferroni adjustment.|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||7.4|0.63|0.05
91718174|NCT00250588|183329123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1||||0.05|TWO_SIDED|95.0|-0.21|6.4||Bonferroni adjustment|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||6.4|-0.21|0.05
91718175|NCT00250588|183329124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.21|TWO_SIDED|95.0|0.18|1.38|||Regression, Logistic|Adjustment for age, race/ethnicity, Spanish language and mother's education||||1.38|0.18|0.21
91718176|NCT00250588|183329124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.85|TWO_SIDED|95.0|0.53|2.83||adjustment for age, race/ethnicity, Spanish language and mother's education|Regression, Logistic|||||2.83|0.53|0.85
91718177|NCT00250588|183329125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.011|TWO_SIDED|95.0|0.13|0.82|||Regression, Logistic|All analyses accounted for repeated measures and included the same terms in the model described previously.||Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.||0.82|0.13|0.011
91718178|NCT02330341|183329144|SUPERIORITY|||||||0.38||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus group||||0.380
91718179|NCT02330341|183329144|SUPERIORITY|||||||0.695|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was p=0.05||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo group||||0.695
91718180|NCT02330341|183329145|SUPERIORITY|||||||0.11||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus group||||0.110
91718181|NCT02330341|183329145|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.910
91718182|NCT02330341|183329146|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus group||||0.010
91718183|NCT02330341|183329146|SUPERIORITY|||||||0.938||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group||||0.938
91718184|NCT02330341|183329147|SUPERIORITY|||||||0.733||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus group||||0.733
91718185|NCT02330341|183329147|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||1.0
91718186|NCT02330341|183329148|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus group||||0.03
91718187|NCT02330341|183329148|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.900
91527589|NCT01976364|182930472|OTHER||LS mean difference|-24.33|||||TWO_SIDED|95.0|-83.35|34.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||34.69|-83.35|
91680398|NCT00741936|183251821|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline||||||<0.05
91680399|NCT00741936|183251822|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
91680400|NCT00741936|183251823|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between two treatment groups in each time frame.||||||<0.05
91680401|NCT00741936|183251824|SUPERIORITY_OR_OTHER|||||||0||95.0|||||simple percentage|||||||0
91680402|NCT00741936|183251825|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
91680403|NCT00741936|183251826|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-samples t-test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91680404|NCT00741936|183251827|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91680405|NCT00741936|183251828|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91680406|NCT00741936|183251829|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91680407|NCT01941940|183251830|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680408|NCT01941940|183251836|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680409|NCT01941940|183251838|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680410|NCT01941940|183251838|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680411|NCT01941940|183251838|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680412|NCT01941940|183251839|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680413|NCT01941940|183251839|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680414|NCT01941940|183251839|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680415|NCT01941940|183251842|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680416|NCT01941940|183251842|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680417|NCT01941940|183251842|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680418|NCT01941940|183251842|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680419|NCT01941940|183251842|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680420|NCT01941940|183251842|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680421|NCT01941940|183251843|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680422|NCT01941940|183251843|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680423|NCT01941940|183251843|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91526835|NCT00474175|182929278|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.173|TWO_SIDED|95.0|-0.14|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.14|0.173
91680424|NCT01941940|183251843|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680425|NCT01941940|183251843|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680426|NCT01941940|183251843|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680427|NCT01941940|183251844|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 2||||<0.0001
91680428|NCT01941940|183251844|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 24||||<0.0001
91680429|NCT01941940|183251844|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 52||||<0.0001
91680430|NCT01941940|183251845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 2||||<0.0001
91680431|NCT01941940|183251845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 24||||<0.0001
91680432|NCT01941940|183251845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 52||||<0.0001
91680433|NCT01941940|183251846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 2||||<0.0001
91680434|NCT01941940|183251846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 24||||<0.0001
91680435|NCT01941940|183251846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 52||||<0.0001
91680436|NCT01941940|183251847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 2||||<0.0001
91680437|NCT01941940|183251847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 2||||<0.0001
91680438|NCT01941940|183251847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 2||||<0.0001
91487258|NCT00191906|182846872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
91680439|NCT01941940|183251847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 24||||<0.0001
91680440|NCT01941940|183251847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 24||||<0.0001
91680441|NCT01941940|183251847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 24||||<0.0001
91680442|NCT01941940|183251847|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 52||||0.0004
91680443|NCT01941940|183251847|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 52||||0.0004
91680444|NCT01941940|183251847|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 52||||0.0004
91680445|NCT01941940|183251848|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 2||||<0.0001
91680446|NCT01941940|183251848|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 24||||<0.0001
91680447|NCT01941940|183251848|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 52||||<0.0001
91680448|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 2||||<0.0001
91680449|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 2||||<0.0001
91680450|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 2||||<0.0001
91680451|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 24||||<0.0001
91680452|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 24||||<0.0001
91680453|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 24||||<0.0001
91680454|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 52||||<0.0001
91680455|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 52||||<0.0001
91680456|NCT01941940|183251849|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 52||||<0.0001
91487259|NCT00191906|182846873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
91680457|NCT01941940|183251850|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 2||||<0.0001
91680458|NCT01941940|183251850|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 24||||<0.0001
91680459|NCT01941940|183251850|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 52||||<0.0001
91680460|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 2||||<0.0001
91680461|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 2||||<0.0001
91680462|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 2||||<0.0001
91680463|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 24||||<0.0001
91680464|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 24||||<0.0001
91680465|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 24||||<0.0001
91680466|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 52||||<0.0001
91680467|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 52||||<0.0001
91680468|NCT01941940|183251851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 52||||<0.0001
91680469|NCT01941940|183251852|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 2||||<0.0001
91680470|NCT01941940|183251852|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 24||||<0.0001
91680471|NCT01941940|183251852|SUPERIORITY_OR_OTHER|||||||0.0016|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 52||||0.0016
91680472|NCT01941940|183251855|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680473|NCT01941940|183251855|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680474|NCT01941940|183251855|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680475|NCT01941940|183251856|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680476|NCT01941940|183251856|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91718188|NCT02330341|183329149|SUPERIORITY|||||||0.519||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus group||||0.519
91718189|NCT02330341|183329149|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.922
91718190|NCT02330341|183329150|SUPERIORITY|||||||0.605||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus group||||0.605
91718191|NCT02330341|183329150|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on placebo group||||0.105
91718192|NCT02330341|183329151|SUPERIORITY|||||||0.687||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus group||||0.687
91718193|NCT02330341|183329151|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.021
91718194|NCT02330341|183329152|SUPERIORITY|||||||0.339||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus group||||0.339
91718195|NCT02330341|183329152|SUPERIORITY|||||||0.246||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.246
91718196|NCT02330341|183329153|SUPERIORITY|||||||0.775||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus group||||0.775
91718197|NCT02330341|183329153|SUPERIORITY|||||||0.195||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.195
91718198|NCT02330341|183329154|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus group||||0.040
91718199|NCT02330341|183329154|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||1.000
91718200|NCT02330341|183329155|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus group||||0.021
91718201|NCT02330341|183329155|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.080
91718202|NCT02330341|183329156|SUPERIORITY|||||||0.465||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus group||||0.465
91718203|NCT02330341|183329156|SUPERIORITY|||||||0.574||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.574
91718204|NCT02330341|183329157|SUPERIORITY|||||||0.48||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus group||||0.480
91718205|NCT02330341|183329157|SUPERIORITY|||||||0.383||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.383
91718206|NCT02330341|183329158|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus group||||0.034
91718207|NCT02330341|183329158|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.080
91718208|NCT02330341|183329159|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus group||||0.017
91718209|NCT02330341|183329159|SUPERIORITY|||||||0.082||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.082
91718210|NCT02330341|183329160|SUPERIORITY|||||||0.17||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus group||||0.170
91718211|NCT02330341|183329160|SUPERIORITY|||||||0.199||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group||||0.199
91718212|NCT03555149|183329177|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
91718213|NCT03555149|183329177|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib + AB928) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
91718214|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.67|2.73||||||||2.73|0.67|
91718215|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|2.3|||||TWO_SIDED|95.0|1.08|4.88||||||||4.88|1.08|
91680477|NCT01941940|183251856|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680478|NCT01941940|183251857|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680479|NCT01941940|183251857|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680480|NCT01941940|183251857|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680481|NCT01941940|183251858|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680482|NCT01941940|183251858|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680483|NCT01941940|183251858|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91718216|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.18||||||||2.18|0.29|
91680484|NCT01941940|183251860|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680485|NCT01941940|183251860|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680486|NCT01941940|183251860|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
91680487|NCT01941940|183251861|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.0045
91680488|NCT01941940|183251861|SUPERIORITY_OR_OTHER|||||||0.1992|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.1992
91680489|NCT04135196|183251867|OTHER|||||||0.119|||||||Regression, Linear|||"The power analysis for the overall study was based on 12-month change in UD iBMC. The power calculation, based on pilot data, determined that 20 participants per group would have 80% power to detect a 1.0±1.1% change.~The null hypothesis was that change in UD iBMC was not proportional to strain magnitude. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group."|"Overall model fit: R\^2=0.101, F=2.244, df1=2, df2=40, p=0.119~Contrast between the low strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.007, Beta=0.374, t=2.114, p=0.041, 95% CI of B: \[0.001, 0.030\]~Contrast between the high strain magnitude group and the control group: B=0.009, Std. Error of estimate of B=0.007, Beta=0.221, t=1.247, p=0.220, 95% CI of B: \[-0.005, 0.022\]"|||0.119
91680490|NCT04135196|183251867|OTHER||||||<|0.01|||||||Regression, Linear|||The null hypothesis was that change in UD iBMC was not proportional to strain rate. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.438, F=12.836, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.009, Beta=0.599, t=4.050, p=\<0.001, 95% CI of B: \[0.018, 0.055\]~Contrast between the high strain rate group and the control group: B=0.041, Std. Error of estimate of B=0.009, Beta=0.678, t=4.589, p=\<0.001, 95% CI of B: \[0.023, 0.060\]"|||<0.01
91718217|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.64|6.24||||||||6.24|0.64|
91680491|NCT04135196|183251868|OTHER|||||||0.809|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain magnitude. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.011, F=0.213, df1=2, df2=40, p=0.809~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.006, Beta=0.039, t=0.209, p=0.836, 95% CI of B: \[-0.012, 0.014\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.006, Beta=-0.077, t=-0.412, p=0.682, 95% CI of B: \[-0.015, 0.010\]"|||0.809
91718218|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|1.74|||||TWO_SIDED|95.0|0.83|3.63||||||||3.63|0.83|
91718219|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.39|1.63||||||||1.63|0.39|
91718220|NCT03555149|183329178|OTHER||Hazard Ratio (HR)|5.64|||||TWO_SIDED|95.0|0.94|33.82||||||||33.82|0.94|
91718221|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.71|2.93||||||Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.93|0.71|
91718222|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.68|2.81||||||Atezolizumab + Isatuximab vs. Regorafenib (Control) Hazard Ratio for OS||2.81|0.68|
91718223|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.72||||||Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.72|0.30|
91718224|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.42|3.84||||||Atezolizumab + Idasanutlin vs. Regorafenib (Control) Hazard Ratio for OS||3.84|0.42|
91718225|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.88||||||Atezolizumab + Regorafenib vs. Regorafenib (Control) Hazard Ratio for OS||1.88|0.39|
91718226|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.43|1.96||||||Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) Hazard Ratio for OS||1.96|0.43|
91718227|NCT03555149|183329179|OTHER|Kaplan-Meier|Hazard Ratio (HR)|2.88|||||TWO_SIDED|95.0|0.33|24.85||||||Atezolizumab + LOAd703 vs. Regorafenib (Control) Hazard Ratio for OS||24.85|0.33|
91718228|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
91718229|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-16.49|||||TWO_SIDED|95.0|-49.78|16.79||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||16.79|-49.78|
91718230|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-14.45|||||TWO_SIDED|95.0|-44.37|15.47||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||15.47|-44.37|
91718231|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-10.56|||||TWO_SIDED|95.0|-32.25|11.14||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||11.14|-32.25|
91718232|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-10.88|||||TWO_SIDED|95.0|-38.62|16.87||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||16.87|-38.62|
91718233|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-23.16|||||TWO_SIDED|95.0|-56.1|9.78||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||9.78|-56.10|
91718234|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-7.78|||||TWO_SIDED|95.0|-39.19|23.62||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||23.62|-39.19|
91718235|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|2.78|||||TWO_SIDED|95.0|-24.08|29.63||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||29.63|-24.08|
91718236|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
91718237|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|16.84|||||TWO_SIDED|95.0|-24.39|58.07||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||58.07|-24.39|
91718238|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|18.88|||||TWO_SIDED|95.0|-34.53|72.3||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||72.30|-34.53|
91718239|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-38.19|57.08||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||57.08|-38.19|
91718240|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-9.21|||||TWO_SIDED|95.0|-54.7|36.28||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||36.28|-54.70|
91718241|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-13.16|||||TWO_SIDED|95.0|-66.74|40.43||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||40.43|-66.74|
91718242|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-9.45|||||TWO_SIDED|95.0|-57.26|38.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||38.36|-57.26|
91718243|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|7.78|||||TWO_SIDED|95.0|-38.18|53.73||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||53.73|-38.18|
91718244|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-5.24|||||TWO_SIDED|95.0|-32.03|21.56||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||21.56|-32.03|
91718245|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|8.64|||||TWO_SIDED|95.0|-23.33|40.6||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.60|-23.33|
91718246|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|5.44|||||TWO_SIDED|95.0|-29.19|40.06||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.06|-29.19|
91680492|NCT04135196|183251868|OTHER|||||||0.155|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain rate. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.107, F=1.971, df1=2, df2=33, p=0.155~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.008, Beta=0.284, t=1.526, p=0.137, 95% CI of B: \[-0.004, 0.027\]~Contrast between the high strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.008, Beta=0.342, t=1.837, p=0.075, 95% CI of B: \[-0.002, 0.030\]"|||0.155
91718247|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|6.71|||||TWO_SIDED|95.0|-22.64|36.06||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||36.06|-22.64|
91718248|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|2.46|||||TWO_SIDED|95.0|-21.31|26.22||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||26.22|-21.31|
91718249|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|10.18|||||TWO_SIDED|95.0|-20.99|41.34||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||41.34|-20.99|
91718250|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|-1.12|||||TWO_SIDED|95.0|-33.59|31.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||31.36|-33.59|
91718251|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-19.06|37.94||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||37.94|-19.06|
91718252|NCT03555149|183329180|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab +LOAd703 vs. Regorafenib (Control) arms||32.19|-0.61|
91718253|NCT02965924|183329184|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91527590|NCT01976364|182930472|OTHER||LS mean difference|-11.64|||||TWO_SIDED|95.0|-60.87|37.58||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||37.58|-60.87|
91680493|NCT04135196|183251869|OTHER|||||||0.991|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain magnitude. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=\<0.001, F=0.009, df1=2, df2=40, p=0.991~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.009, Beta=0.025, t=0.133, p=0.894, 95% CI of B: \[-0.016, 0.018\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.008, Beta=0.012, t=0.063, p=0.950, 95% CI of B: \[-0.016, 0.017\]"|||0.991
91680494|NCT04135196|183251869|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain rate. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.216, F=4.548, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.455, t=2.607, p=0.014, 95% CI of B: \[0.006, 0.052\]~Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.447, t=2.563, p=0.015, 95% CI of B: \[0.006, 0.052\]"|||0.018
91680495|NCT04135196|183251870|OTHER|||||||0.153|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain magnitude. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.090, F=1.968, df1=2, df2=40, p=0.153~Contrast between the low strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.003, Beta=0.352, t=1.973, p=0.055, 95% CI of B: \[0.000, 0.013\]~Contrast between the high strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.003, Beta=0.156, t=0.874, p=0.387, 95% CI of B: \[-0.004, 0.009\]"|||0.153
91680496|NCT04135196|183251870|OTHER|||||||0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain rate. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.331, F=8.152, df1=2, df2=33, p=0.001~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.004, Beta=0.473, t=2.930, p=0.006, 95% CI of B: \[0.004, 0.020\]~Contrast between the high strain rate group and the control group: B=0.016, Std. Error of estimate of B=0.004, Beta=0.617, t=3.828, p=0.001, 95% CI of B: \[0.008, 0.025\]"|||0.001
91680497|NCT04135196|183251871|OTHER|||||||0.84|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain magnitude. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.009, F=0.176, df1=2, df2=40, p=0.840~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.091, t=0.489, p=0.628, 95% CI of B: \[-0.002, 0.003\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.101, t=0.544, p=0.589, 95% CI of B: \[-0.002, 0.003\]"|||0.840
91680498|NCT04135196|183251871|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain rate. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.563, F=21.225, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.009, Std. Error of estimate of B=0.002, Beta=0.739, t=5.669, p=\<0.001, 95% CI of B: \[0.005, 0.012\]~Contrast between the high strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.716, t=5.495, p=\<0.001, 95% CI of B: \[0.005, 0.012\]"|||<0.001
91680499|NCT04135196|183251872|OTHER|||||||0.202|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain magnitude. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.077, F=1.665, df1=2, df2=40, p=0.202~Contrast between the low strain magnitude group and the control group: B=-0.005, Std. Error of estimate of B=0.003, Beta=-0.303, t=-1.689, p=0.099, 95% CI of B: \[-0.012, 0.001\]~Contrast between the high strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.003, Beta=-0.266, t=-1.484, p=0.146, 95% CI of B: \[-0.010, 0.002\]"|||0.202
91680500|NCT04135196|183251872|OTHER|||||||0.381|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain rate. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.057, F=0.995, df1=2, df2=33, p=0.381~Contrast between the low strain rate group and the control group: B=0.004, Std. Error of estimate of B=0.003, Beta=0.254, t=1.327, p=0.194, 95% CI of B: \[-0.002, 0.011\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.003, Beta=0.038, t=0.200, p=0.843, 95% CI of B: \[-0.006, 0.008\]"|||0.381
91680501|NCT04135196|183251873|OTHER|||||||0.697|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain magnitude. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.018, F=0.365, df1=2, df2=40, p=0.697~Contrast between the low strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.004, Beta=-0.158, t=-0.854, p=0.398, 95% CI of B: \[-0.012, 0.005\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.004, Beta=-0.078, t=-0.423, p=0.675, 95% CI of B: \[-0.010, 0.006\]"|||0.697
91718254|NCT00808340|183329219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5.|Mean Difference (Final Values)|-0.1249|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.4143|0.1644|||Mixed Models Analysis||Mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1644|-0.4143|
91680502|NCT04135196|183251873|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain rate. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.215, F=4.516, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.005, Beta=0.484, t=2.773, p=0.009, 95% CI of B: \[0.004, 0.0524\]~Contrast between the high strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.005, Beta=0.406, t=2.325, p=0.026, 95% CI of B: \[0.001, 0.022\]"|||0.018
91680503|NCT04135196|183251874|OTHER|||||||0.073|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain magnitude. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.123, F=2.799, df1=2, df2=40, p=0.073~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.413, t=2.361, p=0.023, 95% CI of B: \[0.000, 0.006\]~Contrast between the high strain magnitude group and the control group: B=0.002, Std. Error of estimate of B=0.001, Beta=0.198, t=1.129, p=0.265, 95% CI of B: \[-0.001, 0.004\]"|||0.073
91680504|NCT04135196|183251874|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain rate. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.480, F=15.256, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.590, t=4.153, p=\<0.001, 95% CI of B: \[0.004, 0.012\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.002, Beta=0.734, t=5.164, p=\<0.001, 95% CI of B: \[0.006, 0.014\]"|||<0.001
91680505|NCT04135196|183251875|OTHER|||||||0.101|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain magnitude. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.108, F=2.428, df1=2, df2=40, p=0.101~Contrast between the low strain magnitude group and the control group: B=0.053, Std. Error of estimate of B=0.024, Beta=0.388, t=2.200, p=0.034, 95% CI of B: \[0.004, 0.101\]~Contrast between the high strain magnitude group and the control group: B=0.029, Std. Error of estimate of B=0.022, Beta=0.226, t=1.280, p=0.208, 95% CI of B: \[-0.017, 0.074\]"|||0.101
91680506|NCT04135196|183251875|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain rate. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=01.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.015, Std. Error of estimate of B=0.025, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
91680507|NCT04135196|183251876|OTHER|||||||0.676|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain magnitude. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.019, F=0.395, df1=2, df2=40, p=0.676~Contrast between the low strain magnitude group and the control group: B=0.012, Std. Error of estimate of B=0.015, Beta=0.146, t=0.787, p=0.436, 95% CI of B: \[-0.019, 0.042\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.014, Beta=0.013, t=0.070, p=0.945, 95% CI of B: \[-0.028, 0.029\]"|||0.676
91680508|NCT04135196|183251876|OTHER|||||||0.289|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain rate. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|Overall model fit: R\^2=0.072, F=1.288, df1=2, df2=33, p=0.289 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.018, Beta=0.154, t=0.814, p=0.422, 95% CI of B: \[-0.022, 0.051\] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.018, Beta=0.304, t=1.604, p=0.118, 95% CI of B: \[-0.008, 0.066\]|||0.289
91680509|NCT04135196|183251877|OTHER|||||||0.096|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain magnitude. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.111, F=2.491, df1=2, df2=40, p=0.096~Contrast between the low strain magnitude group and the control group: B=0.026, Std. Error of estimate of B=0.012, Beta=0.391, t=2.222, p=0.032, 95% CI of B: \[0.032, 0.049\]~Contrast between the high strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.011, Beta=0.240, t=1.362, p=0.181, 95% CI of B: \[-0.007, 0.037\]"|||0.096
91680510|NCT04135196|183251877|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain rate. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=1.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.015, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
91527591|NCT01976364|182930472|OTHER||LS mean difference|7.02|||||TWO_SIDED|95.0|-49.73|63.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||63.77|-49.73|
91718255|NCT00808340|183329219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3693|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.6587|-0.07996|||Mixed Models Analysis||The mean difference was calculated as balafilcon A multifocal minus senofilcon A multifocal prod.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.07996|-0.6587|
91718256|NCT00808340|183329220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.04083|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.2485|0.3302|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.3302|-0.2485|
91718257|NCT00808340|183329220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.4608|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.7502|-0.1714|||Mixed Models Analysis||The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.1714|-0.7502|
91718258|NCT00808340|183329221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.02941|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.08153|0.02271|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.02271|-0.08153|
91718259|NCT00808340|183329221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.06765|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.1198|-0.01553|||Mixed Models Analysis||The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.01553|-0.1198|
91718260|NCT00808340|183329222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3304|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.779|0.1183|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1183|-0.779|
91718261|NCT00808340|183329222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.2281|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.6767|0.2206|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||0.2206|-0.6767|
91718262|NCT02027025|183329242|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.64||0.4532|TWO_SIDED|95.0|-1.73|0.78|||ANCOVA|||||0.78|-1.73|0.4532
91718263|NCT02027025|183329242|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.65||0.4704|TWO_SIDED|95.0|-1.76|0.82|||ANCOVA|||||0.82|-1.76|0.4704
91718264|NCT02027025|183329243|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3013|TWO_SIDED|95.0|-0.56|0.17|||ANCOVA|||||0.17|-0.56|0.3013
91718265|NCT02027025|183329243|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2994|TWO_SIDED|95.0|-0.58|0.18|||ANCOVA|||||0.18|-0.58|0.2994
91718266|NCT02027025|183329244|SUPERIORITY|||||||0.3815|||||||Chi-squared|||||||0.3815
91718267|NCT02027025|183329244|SUPERIORITY|||||||0.7491|||||||Chi-squared|||||||0.7491
91718268|NCT02027025|183329245|SUPERIORITY|||||||0.8991|||||||Chi-squared|||||||0.8991
91718269|NCT02027025|183329245|SUPERIORITY|||||||0.8829|||||||Chi-squared|||||||0.8829
91718270|NCT00828711|183329246|SUPERIORITY_OR_OTHER||Difference in Proportions|12.2||||0.057|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure \>80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours||||0.057
91718271|NCT00828711|183329247|SUPERIORITY_OR_OTHER||Median Difference (Net)|-563.0||||0.018|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.018
91718272|NCT00828711|183329249|SUPERIORITY_OR_OTHER||Difference in Proportions|-8.46||||0.153|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - MVI 100|||||0.153
91718273|NCT00828711|183329250|SUPERIORITY_OR_OTHER||Difference in Proportions|2.37||||0.65|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||0.65
91718274|NCT00828711|183329251|SUPERIORITY_OR_OTHER||Difference in Proportions|-22.09|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||<.001
91718275|NCT00828711|183329253|SUPERIORITY_OR_OTHER||Median Difference (Net)|-368.0||||0.007|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdraw consent prior to delivery will be censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.007
91718276|NCT01618968|183329254|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.99|||||TWO_SIDED|90.0|121.61|134.7||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).||134.70|121.61|
91718277|NCT01618968|183329254|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|125.48|||||TWO_SIDED|90.0|119.43|131.84||||||To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).||131.84|119.43|
91526836|NCT00474175|182929278|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.358|TWO_SIDED|95.0|-0.2|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.20|0.358
91526837|NCT00474175|182929278|SUPERIORITY_OR_OTHER||Treatment difference|0.75||||0.135|TWO_SIDED|95.0|-0.23|1.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.72|-0.23|0.135
91680511|NCT04135196|183251878|OTHER|||||||0.332|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain magnitude. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=1.132, df1=2, df2=40, p=0.332~Contrast between the low strain magnitude group and the control group: B=0.016, Std. Error of estimate of B=0.011, Beta=0.271, t=1.493, p=0.143, 95% CI of B: \[-0.006, 0.039\]~Contrast between the high strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.010, Beta=0.115, t=635, p=0.529, 95% CI of B: \[-0.014, 0.028\]"|||0.332
91680512|NCT04135196|183251878|OTHER|||||||0.399|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain rate. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=0.946, df1=2, df2=33, p=0.399~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.012, Beta=0.119, t=0.619, p=0.540, 95% CI of B: \[-0.017, 0.032\]~Contrast between the high strain rate group and the control group: B=0.017, Std. Error of estimate of B=0.012, Beta=0.264, t=1.375, p=0.178, 95% CI of B: \[-0.008, 0.042\]"|||0.399
91680513|NCT04135196|183251879|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~There were no significant relationships found between change in cortical thickness and strain magnitude group at any time point (p\>0.05)."|||
91680514|NCT04135196|183251879|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 3 months, there was a significant overall linear relationship between change in cortical thickness and strain rate group. Additionally, the coefficient representing the contrast between the control group and the high strain rate group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 3 months:~Overall model fit: R\^2=0.258, F=4.519, df1=2, df2=26, p=0.021~Contrast between the high strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.012, Beta=0.574, t=2.967, p=0.006, 95% CI of B: \[0.011, 0.061\]"|||
91680515|NCT04135196|183251880|OTHER|||||||||||||||||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 9 months, there was a significant overall linear relationship between change in BV/TV and strain magnitude group. Additionally, the coefficient representing the contrast between the control group and the low strain magnitude group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 9 months:~Overall model fit: R\^2=0.240, F=5.057, df1=2, df2=32, p=0.012~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.562, t=3.180, p=0.003, 95% CI of B: \[0.001, 0.006\]"|||
91680516|NCT04135196|183251880|OTHER||||||>|0.05|||||||Regression, Linear|||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.|||>0.05
91526838|NCT00474175|182929278|SUPERIORITY_OR_OTHER||Treatment difference|0.48||||0.332|TWO_SIDED|95.0|-0.49|1.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.46|-0.49|0.332
91718278|NCT01618968|183329254|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference ratio|101.85|||||TWO_SIDED|90.0|99.41|104.36||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)||104.36|99.41|
91680517|NCT00006721|183251942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.11|TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||1.05|0.6|0.11
91680518|NCT00006721|183251946|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55||||0.08|TWO_SIDED|95.0|0.95|2.54|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||2.54|0.95|0.08
91680519|NCT05091307|183251974|NON_INFERIORITY|The criterion for non-inferiority (NI) was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.53|||ANOVA|||A/Victoria (H1N1): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.53|1.09|
91680520|NCT05091307|183251974|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.23|||||TWO_SIDED|95.0|1.05|1.45|||ANOVA|||A/Cambodia (H3N2): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.45|1.05|
91680521|NCT05091307|183251974|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.19|||ANOVA|||B/Victoria (B/Victoria): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.19|0.84|
91680522|NCT05091307|183251974|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21|||ANOVA|||B/Phuket (B/Yamagata): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.21|0.88|
91680523|NCT05091307|183251975|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||ANOVA|||Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.26|0.97|
91680524|NCT02752906|183252019|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non- inferiority assumption was rejected.|Percentage Difference|5.0|||||TWO_SIDED|95.0|0.735|9.38||||||Serogroup A||9.38|0.735|
91680525|NCT02752906|183252019|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.16|8.76||||||Serogroup C||8.76|2.16|
91680526|NCT02752906|183252019|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.907|4.55||||||Serogroup Y||4.55|-0.907|
91527592|NCT01976364|182930474|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
91680527|NCT02752906|183252019|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|7.4|||||TWO_SIDED|95.0|4.3|10.9||||||Serogroup W||10.9|4.30|
91680528|NCT00642694|183252092|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91680529|NCT01007942|183252109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0067|TWO_SIDED|95.0|0.65|0.95|||Log Rank|||||0.95|0.65|0.0067
91680530|NCT04492020|183252118|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.0001|TWO_SIDED|95.0|1.63|2.69|||generalized linear mixed model (GLMM)|||||2.69|1.63|<.0001
91680531|NCT04492020|183252119|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.63|2.78|||generalized linear mixed model (GLMM)|||||2.78|1.63|<.0001
91680532|NCT04492020|183252120|SUPERIORITY||Geometric Mean Odds Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.4|1.96|||generalized estimating equation (GEE)|||||1.96|1.40|<.0001
91680533|NCT04492020|183252121|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.39|2.66|||generalized linear mixed model (GLMM)|||||2.66|1.39|<.0001
91680534|NCT01175811|183252126|SUPERIORITY_OR_OTHER||LSmean difference|0.01|||||TWO_SIDED|95.0|-0.14|0.16||||||||0.16|-0.14|
91680535|NCT01175811|183252127|SUPERIORITY_OR_OTHER||LSmean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.16||||||||0.16|-0.15|
91680536|NCT01175811|183252128|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.344
91718279|NCT01618968|183329255|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.65|||||TWO_SIDED|90.0|121.28|134.36||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||134.36|121.28|
91680537|NCT01175811|183252128|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.822
91680538|NCT01175811|183252128|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.417
91680539|NCT01175811|183252128|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.392
91680540|NCT02109419|183252137|OTHER||Pearson Test-retest reliability coeff.|0.8|||<|0.0001|TWO_SIDED||||||Pearson Test-retest reliability coeff.|||HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
91680541|NCT02109419|183252137|OTHER||Pearson test-retest reliability coeff|0.87|||<|0.0001|TWO_SIDED||||||Pearson test-retest reliability coeff|||HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
91680542|NCT02109419|183252137|OTHER||Pearson correlation coefficient|0.6|||<|0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.||||<.0001
91680543|NCT02109419|183252137|OTHER||Pearson correlation coefficient|0.71||||0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.||||0.0001
91680544|NCT02109419|183252137|OTHER||Chronbach's alpha|0.73|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
91680545|NCT02109419|183252137|OTHER||Chronbach's alpha|0.7|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
91680546|NCT04715932|183252138|SUPERIORITY||Odds Ratio (OR)|1.49||||0.3849|TWO_SIDED|95.0|0.6|3.69|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression).||||3.69|0.60|0.3849
91680547|NCT04715932|183252139|SUPERIORITY||Odds Ratio (OR)|1.43||||0.3139|TWO_SIDED|95.0|0.71|2.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.88|0.71|0.3139
91680548|NCT04715932|183252140|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5886|TWO_SIDED|95.0|0.65|2.14|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.14|0.65|0.5886
91680549|NCT04715932|183252141|SUPERIORITY||Odds Ratio (OR)|0.69||||0.2328|TWO_SIDED|95.0|0.38|1.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.27|0.38|0.2328
91487260|NCT00191906|182846874|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||||||0.094
91680550|NCT04715932|183252142|SUPERIORITY||Rate Ratio|1.14||||0.156|TWO_SIDED|95.0|0.95|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression).||||1.37|0.95|0.1560
91680551|NCT04715932|183252143|SUPERIORITY||Rate Ratio|1.06||||0.6233|TWO_SIDED|95.0|0.84|1.33|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.33|0.84|0.6233
91680552|NCT04715932|183252144|SUPERIORITY||Rate Ratio|1.03||||0.829|TWO_SIDED|95.0|0.78|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.37|0.78|0.8290
91680553|NCT04715932|183252145|SUPERIORITY||Rate Ratio|0.98||||0.9222|TWO_SIDED|95.0|0.69|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.40|0.69|0.9222
91680554|NCT04715932|183252146|SUPERIORITY|||||||0.8834|||||||Log Rank|||||||0.8834
91680555|NCT04715932|183252147|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9416|TWO_SIDED|95.0|0.59|1.77|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.77|0.59|0.9416
91680556|NCT04715932|183252148|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6296|TWO_SIDED|95.0|0.49|1.55|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.55|0.49|0.6296
91680557|NCT04715932|183252149|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3711|TWO_SIDED|95.0|0.41|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.41|0.3711
91680558|NCT04715932|183252150|SUPERIORITY||Odds Ratio (OR)|0.82||||0.5696|TWO_SIDED|95.0|0.42|1.61|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.61|0.42|0.5696
91680559|NCT04715932|183252151|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7583|TWO_SIDED|95.0|0.26|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.26|0.7583
91680560|NCT04715932|183252152|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8091|TWO_SIDED|95.0|0.2|3.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.58|0.20|0.8091
91680561|NCT04715932|183252153|SUPERIORITY||Odds Ratio (OR)|1.67||||0.5591|TWO_SIDED|95.0|0.3|9.42|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||9.42|0.30|0.5591
91680562|NCT04715932|183252154|SUPERIORITY|||||||0.9983|||||||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||||0.9983
91680563|NCT04715932|183252155|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1068|TWO_SIDED|95.0|0.9|2.82|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.82|0.90|0.1068
91680564|NCT04715932|183252156|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8382|TWO_SIDED|95.0|0.57|1.98|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.98|0.57|0.8382
91680565|NCT04715932|183252157|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5912|TWO_SIDED|95.0|0.59|2.51|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.51|0.59|0.5912
91487261|NCT00191906|182846875|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction||||||0.312
91527593|NCT01976364|182930474|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
91680566|NCT04715932|183252159|SUPERIORITY||Odds Ratio (OR)|0.78||||0.3686|TWO_SIDED|95.0|0.45|1.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.35|0.45|0.3686
91680567|NCT04715932|183252160|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8711|TWO_SIDED|95.0|0.59|1.86|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.86|0.59|0.8711
91680568|NCT04715932|183252161|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9124|TWO_SIDED|95.0|0.57|1.87|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.87|0.57|0.9124
91680569|NCT04715932|183252162|SUPERIORITY||Odds Ratio (OR)|0.7||||0.2952|TWO_SIDED|95.0|0.36|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.37|0.36|0.2952
91680570|NCT04715932|183252163|SUPERIORITY||Odds Ratio (OR)|1.2||||0.5894|TWO_SIDED|95.0|0.62|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.62|0.5894
91680571|NCT04715932|183252164|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7887|TWO_SIDED|95.0|0.45|2.89|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.89|0.45|0.7887
91680572|NCT04715932|183252165|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6348|TWO_SIDED|95.0|0.2|2.7|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.70|0.20|0.6348
91680573|NCT04715932|183252166|SUPERIORITY||Odds Ratio (OR)|0.39||||0.4257|TWO_SIDED|95.0|0.04|3.92|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.92|0.04|0.4257
91680574|NCT04715932|183252167|SUPERIORITY||Odds Ratio (OR)|1.66||||0.1113|TWO_SIDED|95.0|0.89|3.11|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.11|0.89|0.1113
91680575|NCT04715932|183252168|SUPERIORITY||Odds Ratio (OR)|1.57||||0.2613|TWO_SIDED|95.0|0.71|3.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.47|0.71|0.2613
91680576|NCT04715932|183252169|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7273|TWO_SIDED|95.0|0.27|2.49|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.49|0.27|0.7273
91680577|NCT04715932|183252170|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8909|TWO_SIDED|95.0|0.19|4.19|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.19|0.19|0.8909
91680578|NCT04715932|183252171|SUPERIORITY||Odds Ratio (OR)|1.52||||0.1438|TWO_SIDED|95.0|0.87|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.87|0.1438
91680579|NCT04715932|183252172|SUPERIORITY||Odds Ratio (OR)|1.38||||0.344|TWO_SIDED|95.0|0.71|2.68|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.68|0.71|0.3440
91680580|NCT04715932|183252173|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5968|TWO_SIDED|95.0|0.58|2.56|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.56|0.58|0.5968
91718280|NCT01618968|183329255|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|125.2|||||TWO_SIDED|90.0|119.16|131.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||131.55|119.16|
91487262|NCT00191906|182846876|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.||||0.508
91680581|NCT04715932|183252174|SUPERIORITY||Odds Ratio (OR)|1.52||||0.362|TWO_SIDED|95.0|0.62|3.76|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.76|0.62|0.3620
91680582|NCT04715932|183252175|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0875|TWO_SIDED|95.0|0.91|4.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.27|0.91|0.0875
91487263|NCT00191906|182846877|SUPERIORITY_OR_OTHER|||||||0.769||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls||||0.769
91680583|NCT04715932|183252176|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8397|TWO_SIDED|95.0|0.36|2.32|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.32|0.36|0.8397
91680584|NCT04715932|183252177|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6265|TWO_SIDED|95.0|0.4|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.40|0.6265
91680585|NCT04715932|183252178|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8528|TWO_SIDED|95.0|0.16|8.91|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||8.91|0.16|0.8528
91680586|NCT04715932|183252179|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2983|TWO_SIDED|95.0|0.77|2.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.35|0.77|0.2983
91680587|NCT04715932|183252180|SUPERIORITY||Odds Ratio (OR)|1.19||||0.5611|TWO_SIDED|95.0|0.66|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.66|0.5611
91680588|NCT04715932|183252181|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4643|TWO_SIDED|95.0|0.65|2.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.58|0.65|0.4643
91680589|NCT04715932|183252182|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5063|TWO_SIDED|95.0|0.53|3.62|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.62|0.53|0.5063
91680590|NCT04715932|183252183|SUPERIORITY||Odds Ratio (OR)|1.41||||0.2292|TWO_SIDED|95.0|0.8|2.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.47|0.80|0.2292
91680591|NCT04715932|183252184|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6097|TWO_SIDED|95.0|0.65|2.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.07|0.65|0.6097
91680592|NCT04715932|183252185|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8389|TWO_SIDED|95.0|0.54|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.54|0.8389
91718281|NCT01618968|183329255|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|101.82|||||TWO_SIDED|90.0|99.39|104.31||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||104.31|99.39|
91718282|NCT01618968|183329256|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|94.83|||||TWO_SIDED|90.0|86.42|104.06||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||104.06|86.42|
91718283|NCT01618968|183329256|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|82.12|||||TWO_SIDED|90.0|76.16|88.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||88.55|76.16|
91718284|NCT01618968|183329256|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|115.63|||||TWO_SIDED|90.0|108.83|122.86||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||122.86|108.83|
91718285|NCT00251758|183329262|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91718286|NCT00251758|183329262|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91718287|NCT00251758|183329262|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
91526839|NCT00474175|182929278|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.517|TWO_SIDED|95.0|-0.53|1.06||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.06|-0.53|0.517
91680593|NCT04715932|183252186|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9764|TWO_SIDED|95.0|0.45|2.17|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.17|0.45|0.9764
91680594|NCT04715932|183252187|SUPERIORITY||Odds Ratio (OR)|0.8||||0.4403|TWO_SIDED|95.0|0.46|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.46|0.4403
91680595|NCT04715932|183252188|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5112|TWO_SIDED|95.0|0.39|1.6|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.60|0.39|0.5112
91680596|NCT04715932|183252189|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9306|TWO_SIDED|95.0|0.46|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.46|0.9306
91680597|NCT04715932|183252190|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6046|TWO_SIDED|95.0|0.23|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.23|0.6046
91680598|NCT04715932|183252191|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6963|TWO_SIDED|95.0|0.57|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.57|0.6963
91680599|NCT04715932|183252192|SUPERIORITY||Odds Ratio (OR)|0.65||||0.425|TWO_SIDED|95.0|0.22|1.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.88|0.22|0.4250
91680600|NCT04715932|183252193|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8797|TWO_SIDED|95.0|0.27|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.27|0.8797
91680601|NCT04715932|183252194|SUPERIORITY||Odds Ratio (OR)|3.71||||0.2634|TWO_SIDED|95.0|0.37|37.03|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||37.03|0.37|0.2634
91680602|NCT04715932|183252195|SUPERIORITY||Odds Ratio (OR)|1.5||||0.271|TWO_SIDED|95.0|0.73|3.06|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.06|0.73|0.2710
91680603|NCT04715932|183252196|SUPERIORITY||Odds Ratio (OR)|1.82||||0.1748|TWO_SIDED|95.0|0.77|4.3|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.30|0.77|0.1748
91680604|NCT04715932|183252197|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8513|TWO_SIDED|95.0|0.34|3.63|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.63|0.34|0.8513
91680605|NCT04715932|183252198|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7906|TWO_SIDED|95.0|0.29|5.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||5.07|0.29|0.7906
91680606|NCT03560986|183252199|SUPERIORITY||Mean Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.372||0.2522|TWO_SIDED|95.0|-0.31|1.17||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||1.17|-0.31|0.2522
91680607|NCT00655876|183252206|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.47|TWO_SIDED|95.0|0.7|1.16|||Log Rank|||The sample size was based on the primary hypothesis of a 29% reduction in the hazard rate of death with cetuximab, corresponding to an increase in 2-year overall survival (OS) from 41% to 53% and a hazard ratio (λ\[exp\]/λ\[cont\]) of 0.71 in favor of the cetuximab arm. Assuming an exponential distribution and constant hazards, 400 patients were required to reach 281 OS events, with 80% statistical power, a 1-sided α of 0.025, 4.5 years of accrual, 2 years of follow-up, and 4 interim analyses.||1.16|0.70|0.47
91680608|NCT00655876|183252207|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.66|1.28|||Log Rank|One-sided significance level = 0.025||||1.28|0.66|0.65
91680609|NCT00655876|183252209|SUPERIORITY|||||||0.66|||||||Fisher Exact|One-sided significance level = 0.025||||||0.66
91680610|NCT00655876|183252210|SUPERIORITY|||||||0.04|||||||Chi-squared|Two-sided significance level = 0.05||6-8 weeks post-treatment||||0.04
91680611|NCT00655876|183252210|SUPERIORITY|||||||0.77|||||||Chi-squared|Two-sided significance level = 0.05||1 year||||0.77
91680612|NCT00655876|183252210|SUPERIORITY|||||||0.17|||||||Chi-squared|Two-sided significance level = 0.05||2 years||||0.17
91680613|NCT00699374|183252232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.9993|TWO_SIDED|95.0|1.14|1.5||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.|Log Rank|||||1.50|1.14|0.9993
91680614|NCT00699374|183252233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8857|TWO_SIDED|95.0|0.99|1.3||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition|Log Rank|||||1.30|0.99|0.8857
91680615|NCT00699374|183252234|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8459|TWO_SIDED|95.0|0.98|1.31||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition|Log Rank|||||1.31|0.98|0.8459
91680616|NCT01783548|183252244|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.66||||0.002|TWO_SIDED|95.0|-1.08|-0.24||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.24|-1.08|0.002
91680617|NCT01783548|183252245|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.58||||0.004|TWO_SIDED|95.0|-0.99|-0.18||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.18|-0.99|0.004
91680618|NCT01783548|183252246|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.62||||0.002|TWO_SIDED|95.0|-1.0|-0.23||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.23|-1.00|0.002
91680619|NCT01783548|183252247|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.54||||0.004|TWO_SIDED|95.0|-0.91|-0.17||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.17|-0.91|0.004
91680620|NCT00552578|183252284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17||||0.523||95.0|0.0098|2.8215|||Fisher Exact|||Intent to treat||2.8215|0.0098|0.523
91680621|NCT00552578|183252286|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||No adjustment|Fisher Exact|||Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.||||0.015
91680622|NCT01992523|183252287|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). Data were compared by means of the chi-2 test or Fisher exact test for categorical variables and unpaired t test or Mann-Whitney U-test for continuous variables, as appropriate. A P value \< .05 was considered statistically significant. All tests were two-sided.||||0.006
91680623|NCT00296231|183252318|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||Paired Student's t-test was used to compare pre and post intervention pCO2 values.||||0.011
91680624|NCT04091659|183252320|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|-0.18||||0.65|TWO_SIDED|95.0|-0.85|0.49|||SEM||||The control group, standard education was the reference for this model.|0.49|-0.85|0.65
91680625|NCT04091659|183252321|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|0.26||||0.02|TWO_SIDED|95.0|0.02|0.5|||SEM||The control group, standard education, was the reference|||0.50|0.02|0.02
91718288|NCT00251758|183329264|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
91718289|NCT00251758|183329264|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
91680626|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Overall comparison of treatment groups for incidence of ILI|Chi-squared|||||||0.25
91680627|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparision of ILI incidence in subjects age 50 and older at baseline.|Chi-squared|||||||0.01
91680628|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Comparison of ILI in subjects age \< 50 at baseline|Chi-squared|||||||0.32
91680629|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.|Chi-squared|||||||0.01
91680630|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment|Chi-squared|||||||0.45
91680631|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Comparison of ILI incidence in male subjects|Chi-squared|||||||0.03
91680632|NCT00895947|183252322|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Comparison of ILI incidence in female subjects|Chi-squared|||||||0.99
91680633|NCT00895947|183252323|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Proportion of subjects reporting any cold/flu symptoms during treatment|Chi-squared|||||||0.16
91680634|NCT00895947|183252323|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects reporting moderate to severe feverishness|Chi-squared|||||||0.03
91680635|NCT00895947|183252323|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Proportion of subjects reporting moderate to severe head congestion|Chi-squared|||||||0.04
91680636|NCT00895947|183252323|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Proportion of subjects reporting moderate to severe sore throat|Chi-squared|||||||0.07
91680637|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly|Chi-squared|||||||0.39
91680638|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well|Chi-squared|||||||0.15
91680639|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily|Chi-squared|||||||0.66
91680640|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise|Chi-squared|||||||0.48
91680641|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities|Chi-squared|||||||0.26
91680642|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home|Chi-squared|||||||0.25
91718290|NCT00251758|183329264|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
91680643|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home|Chi-squared|||||||0.20
91680644|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others|Chi-squared|||||||0.20
91680645|NCT00895947|183252324|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life|Chi-squared|||||||0.32
91680646|NCT00895947|183252325|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects in each group reporting one or more days they felt sick|Chi-squared|||||||0.66
91680647|NCT00895947|183252325|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Proportion of subjects in each group reporting one or more days they missed work|Chi-squared|||||||0.88
91680648|NCT00895947|183252325|SUPERIORITY_OR_OTHER|||||||1||95.0||||Proportion of subjects in each group reporting one or more days they visited the doctor|Chi-squared|||||||1.0
91680649|NCT00895947|183252325|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects in each group reporting one or more days they visited the pharmacy|Chi-squared|||||||0.54
91680650|NCT00895947|183252325|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||Proportion of subjects in each group reporting one or more days they took cold/flu medication|Chi-squared|||||||0.24
91680651|NCT00895947|183252325|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||Proportion of subjects in each group reporting one or more days they skipped a planned activity|Chi-squared|||||||0.89
91680652|NCT00895947|183252326|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Proportion of subjects in each group with a confirmed viral respiratory infection|Chi-squared|||||||0.61
91680653|NCT00895947|183252326|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection|Chi-squared|||||||0.003
91680654|NCT00895947|183252326|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe influenza infection|Chi-squared|||||||0.03
91680655|NCT00895947|183252326|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza|Chi-squared|||||||0.03
91680656|NCT00895947|183252327|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects meeting the definition of acute respiratory illness during treatment|Chi-squared|||||||0.54
91680657|NCT00895947|183252327|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment|Chi-squared|||||||0.06
91680658|NCT00895947|183252327|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment|Chi-squared|||||||0.03
91680659|NCT00895947|183252327|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment|Chi-squared|||||||0.60
91680660|NCT01243112|183252336|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||ANOVA|||Null Hypothesis is that no difference would be measured between treatment arms.||||0.359
91680661|NCT01243112|183252337|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANOVA|||||||0.490
91680662|NCT01739348|183252359|SUPERIORITY||Difference in Least Squares Mean|0.2||||0.6287|TWO_SIDED|97.51|-0.9|1.3|||Longitudinal ANCOVA|||||1.3|-0.9|0.6287
91680663|NCT01739348|183252359|SUPERIORITY||Difference in Least Squares Mean|0.4||||0.4625|TWO_SIDED|97.51|-0.8|1.5|||Longitudinal ANCOVA|||||1.5|-0.8|0.4625
91680664|NCT01739348|183252360|SUPERIORITY||Difference in Least Squares Means|0.5||||0.4925|TWO_SIDED|97.51|-1.1|2.1|||Longitudinal ANCOVA|||||2.1|-1.1|0.4925
91680665|NCT01739348|183252360|SUPERIORITY||Difference in Least Squares Means|0.7||||0.3221|TWO_SIDED|97.51|-0.9|2.3|||Longitudinal ANCOVA|||||2.3|-0.9|0.3221
91680666|NCT01739348|183252367|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8426|TWO_SIDED|97.51|-0.4|0.3|||Longitudinal ANCOVA|||||0.3|-0.4|0.8426
91680667|NCT01739348|183252367|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8264|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA|||||0.4|-0.3|0.8264
91680668|NCT01739348|183252368|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.0005|TWO_SIDED|97.51|-1.0|-0.2|||Longitudinal ANCOVA|||||-0.2|-1.0|0.0005
91718291|NCT01387269|183329314|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
91680669|NCT01739348|183252368|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.0002|TWO_SIDED|97.51|-1.1|-0.3|||Longitudinal ANCOVA|||||-0.3|-1.1|0.0002
91680670|NCT01739348|183252369|SUPERIORITY||Ratio of Fold Change from Baseline|0.95||||0.2138|TWO_SIDED|95.0|0.87|1.04|||Longitudinal ANCOVA|||||1.04|0.87|0.2138
91680671|NCT01739348|183252369|SUPERIORITY||Ratio of Fold Change from Baseline|0.97||||0.433|TWO_SIDED|95.0|0.9|1.05|||Longitudinal ANCOVA|||||1.05|0.90|0.4330
91680672|NCT01739348|183252370|SUPERIORITY||Difference in Least Squares Means|-0.03||||0.0066|TWO_SIDED|95.0|-0.05|0.0|||Longitudinal ANCOVA|||||0.00|-0.05|0.0066
91680673|NCT01739348|183252370|SUPERIORITY||Difference in Least Squares Means|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Longitudinal ANCOVA|||||-0.02|-0.06|<0.0001
91680674|NCT01739348|183252372|SUPERIORITY||Difference in Least Squares Means|0.7||||0.2949|TWO_SIDED|95.0|-0.6|2.1|||Longitudinal ANCOVA|||||2.1|-0.6|0.2949
91680675|NCT01739348|183252372|SUPERIORITY||Difference in Least Squares Means|1.1||||0.1372|TWO_SIDED|95.0|-0.4|2.6|||Longitudinal ANCOVA|||||2.6|-0.4|0.1372
91680676|NCT01739348|183252373|SUPERIORITY||Difference in Least Squares Means|0.2||||0.4721|TWO_SIDED|95.0|-0.3|0.7|||Longitudinal ANCOVA|||||0.7|-0.3|0.4721
91680677|NCT01739348|183252373|SUPERIORITY||Difference in Least Squares Means|0.5||||0.0599|TWO_SIDED|95.0|0.0|1.0|||Longitudinal ANCOVA|||||1.0|0.0|0.0599
91680678|NCT01447420|183252377|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Chi-squared|Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.||IL28B Genotypes (CC, CT or TT)||||0.0007
91680679|NCT01447420|183252380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.69|4.14|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia after the first month of treatment vs No anemia||4.14|0.69|
91680680|NCT01447420|183252380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.28|2.59|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia in the first month of treatment vs No anemia||2.59|0.28|
91680681|NCT01447420|183252380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.45|||||TWO_SIDED|95.0|2.27|13.12|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs CT||13.12|2.27|
91680682|NCT01447420|183252380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||||TWO_SIDED|95.0|1.19|13.61|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs TT||13.61|1.19|
91680683|NCT00790335|183252393|SUPERIORITY||Risk Ratio (RR)|0.96||||0.56|TWO_SIDED|95.0|0.82|1.11|||Cochran-Mantel-Haenszel|Adjusted for extent of DVT and for clinical center|Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.|||1.11|0.82|0.56
91680684|NCT00790335|183252394|SUPERIORITY||Risk Ratio (RR)|0.58||||0.38|TWO_SIDED|95.0|0.17|1.98|||Cochran-Mantel-Haenszel|Adjusted by extent of thrombus and clinical center|Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.|||1.98|0.17|0.38
91680685|NCT00790335|183252395|SUPERIORITY||Risk Ratio (RR)|0.94||||0.39|TWO_SIDED|95.0|0.8|1.09|||Cochran-Mantel-Haenszel|Adjusted for thrombus extent and clinical center|No statistically significant difference was seen.|||1.09|0.80|0.39
91680686|NCT00790335|183252396|SUPERIORITY||Risk Ratio (RR)|0.73||||0.04|TWO_SIDED|95.0|0.54|0.98|||Cochran-Mantel-Haenszel|Adjusted by extent of DVT and clinical center|Numerator: PCDT Arm; Denominator: Control Arm|||0.98|0.54|0.04
91680687|NCT00790335|183252397|SUPERIORITY||Risk Ratio (RR)|6.18||||0.049|TWO_SIDED|95.0|0.78|49.2|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.|||49.2|0.78|0.049
91680688|NCT00790335|183252398|SUPERIORITY||Risk Ratio (RR)|1.52||||0.23|TWO_SIDED|95.0|0.76|3.01|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||3.01|0.76|0.23
91680689|NCT00790335|183252399|SUPERIORITY||Risk Ratio (RR)|2.64||||0.03|TWO_SIDED|95.0|1.04|6.68|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.|||6.68|1.04|0.03
91680690|NCT00790335|183252400|SUPERIORITY||Risk Ratio (RR)|1.26||||0.25|TWO_SIDED|95.0|0.85|1.89|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||1.89|0.85|0.25
91680691|NCT00790335|183252401|SUPERIORITY||Risk Ratio (RR)|1.53||||0.5|TWO_SIDED|95.0|0.44|5.28|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm|||5.28|0.44|0.50
91680692|NCT00790335|183252402|SUPERIORITY||Risk Ratio (RR)|1.47||||0.09|TWO_SIDED|95.0|0.94|2.29|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||2.29|0.94|0.09
91680693|NCT00790335|183252404|SUPERIORITY||Risk Ratio (RR)|0.89||||0.83|TWO_SIDED|95.0|0.33|2.44|||Cochran-Mantel-Haenszel|||||2.44|0.33|0.83
91680694|NCT00790335|183252405|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
91680695|NCT00790335|183252406|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
91680696|NCT00790335|183252407|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
91680697|NCT00790335|183252408|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.005|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.005
91680698|NCT00790335|183252409|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
91680699|NCT00790335|183252410|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.23||0.01|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.01
91718292|NCT01387269|183329315|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Wilcoxon rank sum test|||Superiority analysis||||0.1475
91718293|NCT01387269|183329316|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||Superiority analysis||||0.0004
91718294|NCT01387269|183329317|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Mixed Models Analysis|||Superiority analysis||||0.0544
91718295|NCT01387269|183329318|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
91718296|NCT02858908|183329346|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6696||||0.0484|TWO_SIDED|95.0|-1.334|-0.0051|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||-0.0051|-1.3340|0.0484
91718297|NCT02858908|183329346|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6449||||0.0565|TWO_SIDED|95.0|-1.3094|0.0195|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||0.0195|-1.3094|0.0565
91718298|NCT02858908|183329347|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.9102||||0.3732|TWO_SIDED|95.0|-1.1526|2.973|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||2.9730|-1.1526|0.3732
91718299|NCT02858908|183329347|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.3897||||0.1782|TWO_SIDED|95.0|-3.4525|0.6731|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||0.6731|-3.4525|0.1782
91718300|NCT02858908|183329348|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.0213||||0.8886|TWO_SIDED|95.0|-0.3368|0.2941|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.2941|-0.3368|0.8886
91718301|NCT02858908|183329348|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.0152||||0.9204|TWO_SIDED|95.0|-0.3003|0.3307|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.3307|-0.3003|0.9204
91718302|NCT02858908|183329349|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|-42.75||||1|TWO_SIDED|95.0|-1270.0|2178.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||2178.50|-1270.00|1.0000
91718303|NCT02858908|183329349|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|426.75||||0.3125|TWO_SIDED|95.0|-289.5|1198.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||1198.50|-289.50|0.3125
91718304|NCT02858908|183329351|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.1||||0.003|TWO_SIDED|95.0|2.6|3.7||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.7|2.6|0.0030
91718305|NCT02858908|183329351|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.0||||0.0009|TWO_SIDED|95.0|2.4|3.6||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.6|2.4|0.0009
91526840|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.35|0.50|<0.001
91680700|NCT00790335|183252411|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
91680701|NCT00790335|183252412|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.03
91680702|NCT00790335|183252413|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.26||0.37|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.|||||0.37
91680703|NCT00790335|183252414|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.16||0.99|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.|||||0.99
91680704|NCT00790335|183252415|SUPERIORITY||Mean Difference (Net)|4.2|STANDARD_ERROR_OF_MEAN|2.39||0.08|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference in the change from baseline to 24 months between the two treatment arms.|||||0.08
91680705|NCT00790335|183252416|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
91680706|NCT00790335|183252417|SUPERIORITY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.03|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.03
91680707|NCT00790335|183252418|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.23||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
91680708|NCT00790335|183252419|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.05
91680709|NCT02695537|183252472|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
91680710|NCT02695537|183252473|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
91680711|NCT02792699|183252478|OTHER||Geometric LS Mean|152371.4|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680712|NCT02792699|183252478|OTHER||LS Geometric Mean|159236.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680713|NCT02792699|183252478|OTHER||LS Geometric Mean|172213.2|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680714|NCT02792699|183252478|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9569|||||TWO_SIDED|90.0|0.887|1.0323||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0323|0.8870|
91680715|NCT02792699|183252478|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8848|||||TWO_SIDED|90.0|0.8204|0.9542||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9542|0.8204|
91526841|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.55||||0.011|TWO_SIDED|95.0|0.13|0.97||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.97|0.13|0.011
91487264|NCT00191906|182846878|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.302
91680716|NCT02792699|183252478|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9246|||||TWO_SIDED|90.0|0.8575|0.997||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9970|0.8575|
91680717|NCT02792699|183252479|OTHER||Geometric LS Mean|368.43|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91718306|NCT02858908|183329352|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.132||||0.1857|TWO_SIDED|95.0|-0.33|0.066|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||0.066|-0.330|0.1857
91526842|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.72|0.03|0.031
91680718|NCT02792699|183252479|OTHER||LS Geometric Mean|374.44|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680719|NCT02792699|183252479|OTHER||LS Geometric Mean|393.29|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680720|NCT02792699|183252479|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.9356|1.0348||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0348|0.9356|
91680721|NCT02792699|183252479|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9368|||||TWO_SIDED|90.0|0.8912|0.9848||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9848|0.8912|
91680722|NCT02792699|183252479|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9521|||||TWO_SIDED|90.0|0.9055|1.001||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0010|0.9055|
91680723|NCT02792699|183252480|OTHER||Geometric LS Mean|42203.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680724|NCT02792699|183252480|OTHER||LS Geometric Mean|43378.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680725|NCT02792699|183252480|OTHER||LS Geometric Mean|44925.3|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680726|NCT02792699|183252480|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9729|||||TWO_SIDED|90.0|0.9174|1.0318||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0318|0.9174|
91680727|NCT02792699|183252480|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9394|||||TWO_SIDED|90.0|0.8863|0.9958||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9958|0.8863|
91487265|NCT00191906|182846878|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.663
91487266|NCT00191906|182846879|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.||||0.070
91680728|NCT02792699|183252480|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9656|||||TWO_SIDED|90.0|0.9104|1.024||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0240|0.9104|
91527594|NCT01976364|182930474|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
91680729|NCT02792699|183252481|OTHER||Geometric LS Mean|149590.5|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680730|NCT02792699|183252481|OTHER||LS Geometric Mean|155778.7|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680731|NCT02792699|183252481|OTHER||LS Geometric Mean|166811.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680732|NCT02792699|183252481|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.895|1.0303||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0303|0.8950|
91680733|NCT02792699|183252481|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8968|||||TWO_SIDED|90.0|0.8363|0.9616||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9616|0.8363|
91680734|NCT02792699|183252481|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9339|||||TWO_SIDED|90.0|0.8707|1.0016||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0016|0.8707|
91680735|NCT02792699|183252482|OTHER||Geometric LS Mean|304.04|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680736|NCT02792699|183252482|OTHER||LS Geometric Mean|305.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680737|NCT02792699|183252482|OTHER||LS Geometric Mean|320.87|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
91680738|NCT02792699|183252482|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9942|||||TWO_SIDED|90.0|0.9461|1.0448||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0448|0.9461|
91680739|NCT02792699|183252482|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9475|||||TWO_SIDED|90.0|0.9021|0.9953||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9953|0.9021|
91680740|NCT02792699|183252482|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9531|||||TWO_SIDED|90.0|0.907|1.0015||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0015|0.9070|
91680741|NCT02792699|183252491|EQUIVALENCE|Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).|LS Mean Difference|0.02|||||TWO_SIDED|90.0|-0.225|0.264||||||If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.||0.264|-0.225|
91680742|NCT02792699|183252491|OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.353|0.213||||||||0.213|-0.353|
91680743|NCT02792699|183252491|OTHER||LS Mean Difference|0.11|||||TWO_SIDED|90.0|-0.171|0.392||||||||0.392|-0.171|
91680744|NCT02792699|183252492|OTHER||LS Mean Difference|0.064|||||TWO_SIDED|90.0|-0.203|0.33||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.330|-0.203|
91680745|NCT02792699|183252492|OTHER||LS Mean Difference|-0.147|||||TWO_SIDED|90.0|-0.411|0.117||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.117|-0.411|
91680746|NCT02792699|183252492|OTHER||LS Mean Difference|0.502|||||TWO_SIDED|90.0|0.233|0.772||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.772|0.233|
91680747|NCT02792699|183252492|OTHER||LS Mean Difference|0.27|||||TWO_SIDED|90.0|0.0|0.539||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.539|0.000|
91680748|NCT02792699|183252492|OTHER||LS Mean Difference|0.255|||||TWO_SIDED|90.0|-0.04|0.55||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.550|-0.040|
91680749|NCT02792699|183252492|OTHER||LS Mean Difference|0.16|||||TWO_SIDED|90.0|-0.135|0.455||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.455|-0.135|
91680750|NCT02792699|183252492|OTHER||LS Mean Difference|0.262|||||TWO_SIDED|90.0|-0.04|0.564||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.564|-0.040|
91680751|NCT02792699|183252492|OTHER||LS Mean Difference|0.08|||||TWO_SIDED|90.0|-0.216|0.376||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.376|-0.216|
91680752|NCT02792699|183252493|OTHER||Risk Ratio (RR)|0.9339|||||TWO_SIDED|90.0|0.7696|1.1332||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1332|0.7696|
91680753|NCT02792699|183252493|OTHER||Risk Difference (RD)|-0.036|||||TWO_SIDED|90.0|-0.1495|0.0775||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0775|-0.1495|
91680754|NCT02792699|183252493|OTHER||Risk Ratio (RR)|1.0392|||||TWO_SIDED|90.0|0.8436|1.2801||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2801|0.8436|
91487267|NCT00191906|182846879|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.179
91680755|NCT02792699|183252493|OTHER||Risk Difference (RD)|0.0246|||||TWO_SIDED|90.0|-0.091|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0910|
91680756|NCT02792699|183252493|OTHER||Risk Ratio (RR)|0.878|||||TWO_SIDED|90.0|0.7573|1.0179||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0179|0.7573|
91680757|NCT02792699|183252493|OTHER||Risk Difference (RD)|-0.0794|||||TWO_SIDED|90.0|-0.1834|0.0247||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0247|-0.1834|
91680758|NCT02792699|183252493|OTHER||Risk Ratio (RR)|1.0426|||||TWO_SIDED|90.0|0.877|1.2394||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2394|0.8770|
91680759|NCT02792699|183252493|OTHER||Risk Difference (RD)|0.0348|||||TWO_SIDED|90.0|-0.0758|0.1454||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1454|-0.0758|
91680760|NCT02792699|183252493|OTHER||Risk Ratio (RR)|1.0102|||||TWO_SIDED|90.0|0.8743|1.1671||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1671|0.8743|
91680761|NCT02792699|183252493|OTHER||Risk Difference (RD)|0.0199|||||TWO_SIDED|90.0|-0.0835|0.1234||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1234|-0.0835|
91680762|NCT02792699|183252493|OTHER||Risk Ratio (RR)|1.0793|||||TWO_SIDED|90.0|0.9244|1.2601||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2601|0.9244|
91680763|NCT02792699|183252493|OTHER||Risk Difference (RD)|0.0561|||||TWO_SIDED|90.0|-0.0493|0.1615||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1615|-0.0493|
91718307|NCT02858908|183329352|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.325||||0.0054|TWO_SIDED|95.0|-0.549|-0.102|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||-0.102|-0.549|0.0054
91718308|NCT02858908|183329355|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.162||||0.0111|TWO_SIDED|95.0|-3.731|-0.593|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||-0.593|-3.731|0.0111
91718309|NCT02858908|183329355|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.955||||0.2088|TWO_SIDED|95.0|-2.525|0.614|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||0.614|-2.525|0.2088
91718310|NCT02858908|183329356|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.77||||0.0728|TWO_SIDED|95.0|-3.71|0.18|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||0.18|-3.71|0.0728
91718311|NCT02858908|183329356|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.99||||0.0456|TWO_SIDED|95.0|-3.94|-0.04|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||-0.04|-3.94|0.0456
91718312|NCT02858908|183329356|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.41||||0.0058|TWO_SIDED|95.0|-4.03|-0.8|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.80|-4.03|0.0058
91718313|NCT02858908|183329356|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.95||||0.0208|TWO_SIDED|95.0|-3.56|-0.34|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.34|-3.56|0.0208
91718314|NCT02858908|183329357|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.054||||0.0068|TWO_SIDED|95.0|-0.092|-0.017|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||-0.017|-0.092|0.0068
91718315|NCT02858908|183329357|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.009||||0.609|TWO_SIDED|95.0|-0.047|0.028|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||0.028|-0.047|0.6090
91526843|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.78|||<|0.001|TWO_SIDED|95.0|0.33|1.23||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.23|0.33|<0.001
91487268|NCT01188421|182846887|SUPERIORITY||F-value for main effect of Group|1.31||||0.275|TWO_SIDED|||||Main effect of Group (e.g., Buprenorphine, Tramadol, Clonidine) on COWS Total Score Ratings|ANOVA|||A power analysis determined 40 participants in each group would detect a moderate effect size, assuming an alpha of 0.05 and 80% power. Due to the expiration of buprenorphine tablets, recruitment was terminated after enrolling 103 participants. This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.||||.275
91718316|NCT02858908|183329358|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|3.4||||0.0011|TWO_SIDED|95.0|3.0|3.7||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||3.7|3.0|0.0011
91718317|NCT02858908|183329358|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|4.0||||1|TWO_SIDED|95.0|3.6|4.4||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||4.4|3.6|1.0000
91718318|NCT02858908|183329359|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-5.91|||<|0.0001|TWO_SIDED|95.0|-8.35|-3.47|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-3.47|-8.35|<0.0001
91718319|NCT02858908|183329359|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-3.27||||0.0116|TWO_SIDED|95.0|-5.71|-0.83|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-0.83|-5.71|0.0116
91718320|NCT02858908|183329360|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-1.1||||0.6631|TWO_SIDED|95.0|-6.5|4.3|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||4.3|-6.5|0.6631
91718321|NCT02858908|183329360|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-0.1||||0.9546|TWO_SIDED|95.0|-5.5|5.2|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||5.2|-5.5|0.9546
91718322|NCT05994963|183329393|OTHER||Ratio of adjusted geometric means|58.84|||||TWO_SIDED|90.0|40.45|85.6|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||85.60|40.45|
91718323|NCT05994963|183329394|OTHER||Ratio of adjusted geometric means|56.93|||||TWO_SIDED|90.0|38.71|83.73|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||83.73|38.71|
91718324|NCT05994963|183329395|OTHER||Ratio of adjusted geometric means|50.13|||||TWO_SIDED|90.0|33.01|76.13|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||76.13|33.01|
91718325|NCT05994963|183329396|OTHER||Ratio of adjusted geometric means|202.52|||||TWO_SIDED|90.0|138.43|296.27|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||296.27|138.43|
91718326|NCT05994963|183329397|OTHER||Ratio of adjusted geometric means|196.11|||||TWO_SIDED|90.0|131.01|293.55|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||293.55|131.01|
91487269|NCT01188421|182846887|SUPERIORITY||F-value for main effect of Phase|3.57||||0.03|TWO_SIDED|||||Main effect for Phase (e.g., Stabilization, Taper, Post-Taper) on COWS total score.|ANOVA|||||||0.03
91487270|NCT01188421|182846887|SUPERIORITY||F-value for the main effect of Group x P|2.03||||0.092|TWO_SIDED|||||Main effect for Group x Phase interaction on COWS Total Score|ANOVA|||||||0.092
91487271|NCT01604408|182846890|SUPERIORITY_OR_OTHER||LS Mean Difference|0.426|||<|0.001|TWO_SIDED|95.0|0.192|0.66|||Mixed Model Repeated Measures|||||0.660|0.192|<0.001
91680764|NCT02792699|183252493|OTHER||Risk Ratio (RR)|0.8848|||||TWO_SIDED|90.0|0.7759|1.0091||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0091|0.7759|
91487272|NCT01604408|182846891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.461||||0.073|TWO_SIDED|90.0|-0.883|-0.039|||Mixed Model Repeated Measures|||||-0.039|-0.883|0.073
91680765|NCT02792699|183252493|OTHER||Risk Difference (RD)|-0.0776|||||TWO_SIDED|90.0|-0.1789|0.0237||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0237|-0.1789|
91680766|NCT02792699|183252493|OTHER||Risk Ratio (RR)|0.9982|||||TWO_SIDED|90.0|0.8585|1.1605||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1605|0.8585|
91680767|NCT02792699|183252493|OTHER||Risk Difference (RD)|0.0008|||||TWO_SIDED|90.0|-0.1038|0.1054||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1054|-0.1038|
91680768|NCT02792699|183252493|OTHER||Risk Ratio (RR)|0.7862|||||TWO_SIDED|90.0|0.6722|0.9196||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9196|0.6722|
91680769|NCT02792699|183252493|OTHER||Risk Difference (RD)|-0.2004|||||TWO_SIDED|90.0|-0.3066|-0.0941||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0941|-0.3066|
91680770|NCT02792699|183252493|OTHER||Risk Ratio (RR)|0.8804|||||TWO_SIDED|90.0|0.7587|1.0215||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0215|0.7587|
91680771|NCT02792699|183252493|OTHER||Risk Difference (RD)|-0.1037|||||TWO_SIDED|90.0|-0.2066|-0.0007||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0007|-0.2066|
91680772|NCT02792699|183252494|OTHER||Risk Ratio (RR)|0.9256|||||TWO_SIDED|90.0|0.64|1.3388||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3388|0.6400|
91680773|NCT02792699|183252494|OTHER||Risk Difference (RD)|-0.0181|||||TWO_SIDED|90.0|-0.1209|0.0847||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0847|-0.1209|
91680774|NCT02792699|183252494|OTHER||Risk Ratio (RR)|1.0868|||||TWO_SIDED|90.0|0.7328|1.6119||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6119|0.7328|
91680775|NCT02792699|183252494|OTHER||Risk Difference (RD)|0.0201|||||TWO_SIDED|90.0|-0.0803|0.1205||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1205|-0.0803|
91680776|NCT02792699|183252494|OTHER||Risk Ratio (RR)|0.7095|||||TWO_SIDED|90.0|0.5387|0.9346||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9346|0.5387|
91680777|NCT02792699|183252494|OTHER||Risk Difference (RD)|-0.1109|||||TWO_SIDED|90.0|-0.2231|0.0013||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0013|-0.2231|
91680778|NCT02792699|183252494|OTHER||Risk Ratio (RR)|1.0882|||||TWO_SIDED|90.0|0.7829|1.5127||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.5127|0.7829|
91680779|NCT02792699|183252494|OTHER||Risk Difference (RD)|0.0441|||||TWO_SIDED|90.0|-0.0626|0.1508||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1508|-0.0626|
91680780|NCT02792699|183252494|OTHER||Risk Ratio (RR)|0.9612|||||TWO_SIDED|90.0|0.7273|1.2705||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2705|0.7273|
91680781|NCT02792699|183252494|OTHER||Risk Difference (RD)|0.002|||||TWO_SIDED|90.0|-0.1081|0.1122||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1122|-0.1081|
91680782|NCT02792699|183252494|OTHER||Risk Ratio (RR)|1.0029|||||TWO_SIDED|90.0|0.756|1.3305||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3305|0.7560|
91680783|NCT02792699|183252494|OTHER||Risk Difference (RD)|0.0039|||||TWO_SIDED|90.0|-0.1056|0.1135||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1135|-0.1056|
91680784|NCT02792699|183252494|OTHER||Risk Ratio (RR)|0.8373|||||TWO_SIDED|90.0|0.6797|1.0316||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0316|0.6797|
91680785|NCT02792699|183252494|OTHER||Risk Difference (RD)|-0.0863|||||TWO_SIDED|90.0|-0.2029|0.0302||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0302|-0.2029|
91680786|NCT02792699|183252494|OTHER||Risk Ratio (RR)|1.1191|||||TWO_SIDED|90.0|0.878|1.4264||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4264|0.8780|
91680787|NCT02792699|183252494|OTHER||Risk Difference (RD)|0.0288|||||TWO_SIDED|90.0|-0.0827|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0827|
91680788|NCT02792699|183252494|OTHER||Risk Ratio (RR)|0.8376|||||TWO_SIDED|90.0|0.6807|1.0307||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0307|0.6807|
91680789|NCT02792699|183252494|OTHER||Risk Difference (RD)|-0.0781|||||TWO_SIDED|90.0|-0.2014|0.0452||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0452|-0.2014|
91680790|NCT02792699|183252494|OTHER||Risk Ratio (RR)|1.0548|||||TWO_SIDED|90.0|0.8351|1.3321||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3321|0.8351|
91680791|NCT02792699|183252494|OTHER||Risk Difference (RD)|0.0141|||||TWO_SIDED|90.0|-0.1021|0.1303||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1303|-0.1021|
91680792|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.5926|||||TWO_SIDED|90.0|0.2818|1.2462||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2462|0.2818|
91680793|NCT02792699|183252495|OTHER||Risk Difference (RD)|-0.0574|||||TWO_SIDED|90.0|-0.1285|0.0136||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0136|-0.1285|
91680794|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.7476|||||TWO_SIDED|90.0|0.3383|1.6519||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6519|0.3383|
91680795|NCT02792699|183252495|OTHER||Risk Difference (RD)|-0.0327|||||TWO_SIDED|90.0|-0.0962|0.0308||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0308|-0.0962|
91680796|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.6346|||||TWO_SIDED|90.0|0.3704|1.0872||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0872|0.3704|
91680797|NCT02792699|183252495|OTHER||Risk Difference (RD)|-0.0569|||||TWO_SIDED|90.0|-0.1448|0.031||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0310|-0.1448|
91680798|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.7857|||||TWO_SIDED|90.0|0.445|1.3874||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3874|0.4450|
91680799|NCT02792699|183252495|OTHER||Risk Difference (RD)|-0.0417|||||TWO_SIDED|90.0|-1237.0|0.0403||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0403|-1237|
91487273|NCT01604408|182846892|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.062||||0.191|TWO_SIDED|90.0|-2.4|0.276|||Mixed Model Repeated Measures|||||0.276|-2.400|0.191
91680800|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.9254|||||TWO_SIDED|90.0|0.5772|1.4838||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4838|0.5772|
91680801|NCT02792699|183252495|OTHER||Risk Difference (RD)|0.0156|||||TWO_SIDED|90.0|-0.078|0.1092||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1092|-0.0780|
91680802|NCT02792699|183252495|OTHER||Risk Ratio (RR)|1.112|||||TWO_SIDED|90.0|0.6722|1.8398||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.8398|0.6722|
91680803|NCT02792699|183252495|OTHER||Risk Difference (RD)|0.0244|||||TWO_SIDED|90.0|-0.063|0.1119||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1119|-0.0630|
91487274|NCT01604408|182846893|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.478|TWO_SIDED|90.0|-0.023|0.057|||Mixed Model Repeated Measures|||||0.057|-0.023|0.478
91487275|NCT02664610|182846929|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
91487276|NCT02664610|182846930|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91487277|NCT04102098|182846940|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.012|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||Stratification factors include geographic region (Asia Pacific excluding Japan vs. rest of world) and High risk features/curative procedure (Ablation vs. Resection with 1 high risk feature vs. Resection with 2 or more high risk features).||0.93|0.56|0.0120
91526844|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.031|TWO_SIDED|95.0|0.04|0.94||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.94|0.04|0.031
91487278|NCT03150173|182846955|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
91487279|NCT03150173|182846956|SUPERIORITY|||||||0.148|||||||Chi-squared|||||||0.148
91487280|NCT03150173|182846957|SUPERIORITY||Odds Ratio (OR)|1.445||||0.6132|TWO_SIDED|95.0|0.347|6.018|||Regression, Logistic|Adjustment for baseline self-report of injection-related HIV risk behaviors in the past 30 days||||6.018|0.347|0.6132
91487281|NCT03150173|182846958|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||.051
91487282|NCT03150173|182846959|SUPERIORITY||probability of cost effectiveness|0.94|||||TWO_SIDED||||||||||Data generated from the bootstrapping process were used to construct cost-effectiveness acceptability curves (CEACs), which effectively measure the uncertainty around the ICER point estimate.|||
91527595|NCT01976364|182930474|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
91680804|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.9798|||||TWO_SIDED|90.0|0.6675|1.4384||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4384|0.6675|
91680805|NCT02792699|183252495|OTHER||Risk Difference (RD)|0.0375|||||TWO_SIDED|90.0|-0.0707|0.1456||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1456|-0.0707|
91680806|NCT02792699|183252495|OTHER||Risk Ratio (RR)|1.1831|||||TWO_SIDED|90.0|0.7833|1.787||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7870|0.7833|
91680807|NCT02792699|183252495|OTHER||Risk Difference (RD)|0.0752|||||TWO_SIDED|90.0|-0.0297|0.1802||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1802|-0.0297|
91680808|NCT02792699|183252495|OTHER||Risk Ratio (RR)|0.7027|||||TWO_SIDED|90.0|0.493|1.0017||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0017|0.4930|
91680809|NCT02792699|183252495|OTHER||Risk Difference (RD)|-0.0908|||||TWO_SIDED|90.0|-0.211|0.0294||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0294|-0.2110|
91680810|NCT02792699|183252495|OTHER||Risk Ratio (RR)|1.1449|||||TWO_SIDED|90.0|0.7601|1.7246||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7246|0.7601|
91680811|NCT02792699|183252495|OTHER||Risk Difference (RD)|0.0277|||||TWO_SIDED|90.0|-0.0804|0.1357||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1357|-0.0804|
91680812|NCT02792699|183252496|OTHER||LS Mean Difference|-1.999|||||TWO_SIDED|90.0|-7.673|3.675||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.675|-7.673|
91680813|NCT02792699|183252496|OTHER||LS Mean Difference|0.544|||||TWO_SIDED|90.0|-5.185|6.274||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.274|-5.185|
91680814|NCT02792699|183252496|OTHER||LS Mean Difference|-8.224|||||TWO_SIDED|90.0|-14.102|-2.346||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||-2.346|-14.102|
91680815|NCT02792699|183252496|OTHER||LS Mean Difference|-2.06|||||TWO_SIDED|90.0|-8.052|3.933||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.933|-8.052|
91680816|NCT02792699|183252496|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|90.0|-7.62|4.979||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||4.979|-7.620|
91718327|NCT05994963|183329398|OTHER||Ratio of adjusted geometric means|230.22|||||TWO_SIDED|90.0|145.53|364.2|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||364.20|145.53|
91718328|NCT05994963|183329399|OTHER||Ratio of adjusted geometric means|122.84|||||TWO_SIDED|90.0|93.61|161.19|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||161.19|93.61|
91680817|NCT02792699|183252496|OTHER||LS Mean Difference|0.73|||||TWO_SIDED|90.0|-5.691|7.15||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||7.150|-5.691|
91680818|NCT02792699|183252496|OTHER||LS Mean Difference|-2.207|||||TWO_SIDED|90.0|-8.562|1.417||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||1.417|-8.562|
91487283|NCT03150173|182846960|SUPERIORITY|||||||0.1||||||This is an actual calculated value not a threshold value|non-parametric bootstrapping|Non-parametric bootstrapping of adjusted mean values with 1000 iterations||||||0.10
91680819|NCT02792699|183252496|OTHER||LS Mean Difference|-0.036|||||TWO_SIDED|90.0|-6.497|6.424||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.424|-6.497|
91680820|NCT02792699|183252496|OTHER||LS Mean Difference|-6.629|||||TWO_SIDED|90.0|-13.455|0.197||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.197|-13.455|
91680821|NCT02792699|183252496|OTHER||LS Mean Difference|-3.096|||||TWO_SIDED|90.0|-9.883|3.691||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.691|-9.883|
91680822|NCT02792699|183252497|OTHER||Risk Difference (RD)|-0.0245|||||TWO_SIDED|90.0|-0.1083|0.0593|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0593|-0.1083|
91680823|NCT02792699|183252497|OTHER||Risk Difference (RD)|0.0187|||||TWO_SIDED|90.0|-0.061|0.0984|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0984|-0.0610|
91680824|NCT04420273|183252510|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||1-month survey||||<0.001
91680825|NCT04420273|183252510|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||2- months||||<0.001
91680826|NCT04420273|183252510|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||3-months||||<0.001
91680827|NCT04420273|183252511|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91680828|NCT04420273|183252512|OTHER||||||<|0.1|||||||Chi-squared|||||||< 0.1
91680829|NCT04420273|183252513|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91680830|NCT04420273|183252514|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91680831|NCT04420273|183252515|OTHER|||||||0.459|||||||Chi-squared|||||||0.459
91680832|NCT04420273|183252515|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91680833|NCT04420273|183252516|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91680834|NCT01584843|183252561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83||||0.091|TWO_SIDED|95.0|-21.81|2.14||LSD=Least Significant Difference|Fisher LSD method|||||2.14|-21.81|0.091
91680835|NCT01584843|183252561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.08||||0.338|TWO_SIDED|95.0|-20.39|8.23|||Fisher LSD method|||||8.23|-20.39|0.338
91680836|NCT01584843|183252561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.524|TWO_SIDED|95.0|-9.83|17.33|||Fisher LSD method|||||17.33|-9.83|0.524
91680837|NCT01584843|183252561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85||||0.031|TWO_SIDED|95.0|-24.46|-1.24|||Fisher LSD method|||||-1.24|-24.46|0.031
91680838|NCT01584843|183252561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.72||||0.005|TWO_SIDED|95.0|-28.06|-5.38|||Fisher LSD method|||||-5.38|-28.06|0.005
91680839|NCT01584843|183252561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.87||||0.49|TWO_SIDED|95.0|-15.21|7.47|||Fisher LSD method|||||7.47|-15.21|0.490
91680840|NCT00643565|183252583|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.7189|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.41|0.61|0.7189
91680841|NCT00643565|183252584|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3211|TWO_SIDED|95.0|0.51|1.25|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.25|0.51|0.3211
91680842|NCT02283983|183252607|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91680843|NCT03275064|183252608|SUPERIORITY||Mean Difference (Net)|0.48|||||TWO_SIDED|90.0|-30.73|31.69|||Mixed Models Analysis|||Week 16||31.69|-30.73|
91680844|NCT03275064|183252608|SUPERIORITY||Mean Difference (Net)|3.68|||||TWO_SIDED|90.0|-27.04|34.4|||Mixed Models Analysis|||Week 28||34.40|-27.04|
91680845|NCT03275064|183252609|SUPERIORITY||Mean Difference (Final Values)|1.69|||||TWO_SIDED|90.0|-27.7|31.08|||Mixed Models Analysis|||Week 16||31.08|-27.70|
91680846|NCT03275064|183252609|SUPERIORITY||Mean Difference (Net)|5.97|||||TWO_SIDED|90.0|-23.03|34.97|||Mixed Models Analysis|||Week 28||34.97|-23.03|
91680847|NCT03275064|183252610|SUPERIORITY||Mean Difference (Net)|0.88|||||TWO_SIDED|90.0|-47.27|49.04|||Mixed Models Analysis|||Week 16||49.04|-47.27|
91680848|NCT03275064|183252610|SUPERIORITY||Mean Difference (Net)|2.27|||||TWO_SIDED|90.0|-43.11|47.65|||Mixed Models Analysis|||Week 28||47.65|-43.11|
91718329|NCT05994963|183329400|OTHER||Ratio of adjusted geometric means|104.69|||||TWO_SIDED|90.0|94.54|115.94|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||115.94|94.54|
91718330|NCT05994963|183329401|OTHER||Ratio of adjusted geometric means|124.59|||||TWO_SIDED|90.0|93.46|166.09|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||166.09|93.46|
91487284|NCT03150173|182846961|SUPERIORITY||||||<|0.01||||||This is an actual calculated value not a threshold value.|non-parametric bootstrapping|Non-parametric bootstrapping of adjusted mean values with 1000 iterations||||||< 0.01
91680849|NCT03275064|183252611|SUPERIORITY|Week 29|Mean Difference (Net)|200.18||||0.0131|TWO_SIDED|90.0|54.53|345.83|||Mixed Models Analysis|||||345.83|54.53|0.0131
91680850|NCT03275064|183252611|SUPERIORITY||Mean Difference (Net)|141.87||||0.0544|TWO_SIDED|90.0|-3.83|287.56|||Mixed Models Analysis|||Week 29||287.56|-3.83|0.0544
91680851|NCT03275064|183252611|SUPERIORITY||Mean Difference (Net)|228.27||||0.0067|TWO_SIDED|90.0|80.87|375.67|||Mixed Models Analysis|||Week 53||375.67|80.87|0.0067
91680852|NCT03275064|183252611|SUPERIORITY||Mean Difference (Net)|116.21||||0.0931|TWO_SIDED|90.0|-29.52|261.94|||Mixed Models Analysis|||Week 53||261.94|-29.52|0.0931
91680853|NCT03275064|183252612|SUPERIORITY||Mean Difference (Net)|0.05||||0.0574|TWO_SIDED|90.0|0.0|0.1|||Mixed Models Analysis|||Week 29||0.10|-0.00|0.0574
91680854|NCT03275064|183252612|SUPERIORITY||Mean Difference (Net)|0.06||||0.0248|TWO_SIDED|90.0|0.01|0.11|||Mixed Models Analysis|||Week 29||0.11|0.01|0.0248
91680855|NCT03275064|183252612|SUPERIORITY||Mean Difference (Net)|0.01||||0.3864|TWO_SIDED|90.0|-0.05|0.07|||Mixed Models Analysis|||Week 53||0.07|-0.05|0.3864
91680856|NCT03275064|183252612|SUPERIORITY||Mean Difference (Net)|0.02||||0.329|TWO_SIDED|90.0|-0.05|0.08|||Mixed Models Analysis|||Week 53||0.08|-0.05|0.3290
91680857|NCT03275064|183252613|SUPERIORITY||Mean Difference (Net)|4.75||||0.6184|TWO_SIDED|90.0|-21.36|30.85|||Mixed Models Analysis|||Week 16||30.85|-21.36|0.6184
91680858|NCT03275064|183252613|OTHER||Mean Difference (Net)|-7.32||||0.3194|TWO_SIDED|90.0|-33.16|18.53|||Mixed Models Analysis|||Week 28||18.53|-33.16|0.3194
91680859|NCT03275064|183252614|SUPERIORITY||Mean Difference (Net)|3.38|||||TWO_SIDED|90.0|-1.72|8.47|||Mixed Models Analysis|||Week 29||8.47|-1.72|
91680860|NCT03275064|183252614|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|90.0|-5.22|5.01|||Mixed Models Analysis|||Week 29||5.01|-5.22|
91487285|NCT03150173|182846962|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
91487286|NCT03150173|182846963|SUPERIORITY|||||||0.098|||||||Chi-squared|||||||0.098
91487287|NCT03150173|182846964|SUPERIORITY|||||||0.256|||||||t-test, 2 sided|||||||0.256
91487288|NCT05055453|182846986|OTHER|A Shapiro Wilks test was used to test for normal distribution of the data.|||||<|0.001||||||"Result for comparison between automatic only and preferred app settings."|Durbin-Conover Pairwise Comparison|||||||<0.001
91680861|NCT03275064|183252614|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|90.0|-6.42|4.15|||Mixed Models Analysis|||Week 53||4.15|-6.42|
91680862|NCT03275064|183252614|SUPERIORITY||Mean Difference (Net)|-7.44|||||TWO_SIDED|90.0|-12.68|-2.2|||Mixed Models Analysis|||Week 53||-2.20|-12.68|
91680863|NCT03275064|183252615|SUPERIORITY||Mean Difference (Net)|2.09|||||TWO_SIDED|90.0|-3.49|7.66|||Mixed Models Analysis|||Week 29||7.66|-3.49|
91680864|NCT03275064|183252615|SUPERIORITY||Mean Difference (Net)|0.82|||||TWO_SIDED|90.0|-4.82|6.45|||Mixed Models Analysis|||Week 29||6.45|-4.82|
91680865|NCT03275064|183252615|SUPERIORITY||Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-3.54|8.11|||Mixed Models Analysis|||Week 53||8.11|-3.54|
91680866|NCT03275064|183252615|SUPERIORITY||Mean Difference (Net)|-5.96|||||TWO_SIDED|90.0|-11.81|-0.1|||Mixed Models Analysis|||Week 53||-0.10|-11.81|
91680867|NCT03275064|183252616|SUPERIORITY||Mean Difference (Net)|3.47|||||TWO_SIDED|90.0|-2.21|9.15|||Mixed Models Analysis|||Week 29||9.15|-2.21|
91680868|NCT03275064|183252616|SUPERIORITY||Mean Difference (Net)|-0.63|||||TWO_SIDED|90.0|-6.31|5.04|||Mixed Models Analysis|||Week 29||5.04|-6.31|
91680869|NCT03275064|183252616|SUPERIORITY||Mean Difference (Net)|-2.63|||||TWO_SIDED|90.0|-8.07|2.82|||Mixed Models Analysis|||Week 53||2.82|-8.07|
91680870|NCT03275064|183252616|SUPERIORITY||Mean Difference (Net)|-8.16|||||TWO_SIDED|90.0|-13.61|-2.72|||Mixed Models Analysis|||Week 53||-2.72|-13.61|
91680871|NCT03055650|183252631|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Week 1||||<0.0001
91680872|NCT03055650|183252631|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Month 1||||<0.0001
91680873|NCT03055650|183252632|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Week 1||||<0.0001
91680874|NCT03055650|183252632|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Month 1||||<0.0001
91680875|NCT03055650|183252633|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1||||<0.0001
91680876|NCT03055650|183252633|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1||||<0.0001
91680877|NCT03055650|183252634|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||||||<0.0001
91680878|NCT04305496|183252650|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Stratified log rank test|||||0.71|0.51|<0.001
91680879|NCT04305496|183252651|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Stratified log rank test|||||0.71|0.51|<0.001
91680880|NCT04305496|183252652|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Stratified log-rank test|||||0.65|0.38|<0.001
91680881|NCT04305496|183252653|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Stratified log-rank test|||||0.65|0.38|<0.001
91527596|NCT01976364|182930474|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
91680882|NCT04305496|183252654|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.34|0.76|||Stratified log rank test|||||0.76|0.34|<0.001
91680883|NCT04305496|183252655|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.34|0.76|||Stratified log rank test|||||0.76|0.34|<0.001
91680884|NCT04305496|183252656|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.016|TWO_SIDED|95.0|0.19|0.85|||Stratified log rank test|||||0.85|0.19|0.016
91680885|NCT04305496|183252657|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.016|TWO_SIDED|95.0|0.19|0.85|||Stratified log rank test|||||0.85|0.19|0.016
91680886|NCT00532935|183252660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline A1C value.||||-0.28|-0.66|<0.001
91680887|NCT00532935|183252661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.6|STANDARD_DEVIATION|29.1|<|0.001|TWO_SIDED|95.0|-32.7|-22.4|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-22.4|-32.7|<0.001
91680888|NCT00532935|183252662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.2|STANDARD_DEVIATION|59.7|<|0.001|TWO_SIDED|95.0|-32.1|-8.3|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline 2-hour PMG value.||||-8.3|-32.1|<0.001
91680889|NCT00532935|183252663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|STANDARD_DEVIATION|40.3|<|0.001|TWO_SIDED|95.0|-19.0|-4.9|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-4.9|-19.0|<0.001
91680890|NCT00532935|183252664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.3|2.8||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|Regression, Logistic|logistic regression model included a term for treatment and a covariate for the baseline A1C value.|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|||2.8|1.3|<0.001
91680891|NCT03176459|183252691|SUPERIORITY||LSM treatment difference|-16.5||||0.0117|TWO_SIDED|95.0|-30.8|-2.2|||ANCOVA|||||-2.2|-30.8|0.0117
91680892|NCT03176459|183252692|NON_INFERIORITY|Pre-specified non-inferiority margin of 36|LSM treatment difference (SE)|-30.6||||0.002|TWO_SIDED|95.0|-75.9|14.7|||ANCOVA|||||14.7|-75.9|0.0020
91680893|NCT03176459|183252693|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0012|TWO_SIDED|95.0|1.557|7.906|||LSM probability from logistic regression|||||7.906|1.557|0.0012
91680894|NCT03176459|183252694|SUPERIORITY||Least squares treatment difference|-3.2||||0.0543|TWO_SIDED||||||ANCOVA|||||||.0543
91680895|NCT03176459|183252695|SUPERIORITY||Least squares treatment difference|-11.4||||0.0096|ONE_SIDED||||||ANCOVA|||||||.0096
91680896|NCT03176459|183252696|SUPERIORITY||Least squares treatment difference|-22.4||||0.0175|TWO_SIDED||||||ANCOVA|||||||.0175
91680897|NCT03176459|183252697|SUPERIORITY||Least squares treatment difference|-19.6||||0.0542|TWO_SIDED||||||ANCOVA|||||||.0542
91680898|NCT03176459|183252698|SUPERIORITY|||||||0.7536|||||||Regression, Cox|||||||0.7536
91680899|NCT03176459|183252699|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3609|TWO_SIDED||||||Regression, Logistic|||||||0.3609
91680900|NCT02081209|183252705|OTHER||sucess percentage|82.4|||||TWO_SIDED|95.0|76.4|87.3||||||||87.3|76.4|
91680901|NCT02081209|183252705|OTHER||sucess percentage|77.4|||||TWO_SIDED|95.0|68.1|85.1||||||||85.1|68.1|
91680902|NCT02081209|183252705|OTHER||sucess percentage|79.2|||||TWO_SIDED|95.0|65.0|89.5||||||||89.5|65.0|
91680903|NCT02081209|183252705|OTHER||sucess percentage|94.0|||||TWO_SIDED|95.0|84.6|98.8||||||||98.8|84.6|
91680904|NCT02081209|183252706|OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|1.9|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91680905|NCT02081209|183252706|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.5|2.1||||||||2.1|0.5|
91680906|NCT02081209|183252706|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|2.0|4.1||||||||4.1|2.0|
91680907|NCT02081209|183252707|OTHER||||||||||||||||||Data from the 16-week follow-up questionnaire were tabulated for all subjects with completed questionnaires.. All confidence intervals were calculated at 95%. Alpha was calculated to be 0.05, critical probability (p\*) was calculated to be 0.975. Assuming normal distribution of survey recipients, a standard deviation of 1.96 is used to calculate the standard margin of error.|||
91680908|NCT02022748|183252713|OTHER||Ratio of Geometric Least Square Means|151.13|||||TWO_SIDED|90.0|112.03|203.86|||||Treatment H is the reference treatment.|||203.86|112.03|
91680909|NCT02022748|183252713|OTHER||Ratio of Geometric Least Square Means|161.38|||||TWO_SIDED|90.0|122.52|212.58|||||Treatment H is the reference treatment.|||212.58|122.52|
91680910|NCT02022748|183252713|OTHER||Ratio of Geometric Least Square Means|90.1|||||TWO_SIDED|90.0|78.07|103.98|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||103.98|78.07|
91680911|NCT02022748|183252714|OTHER||Ratio of Geometric Least Square Means|117.09|||||TWO_SIDED|90.0|84.51|162.22|||||Treatment H is the reference treatment.|||162.22|84.51|
91680912|NCT02022748|183252714|OTHER||Ratio of Geometric Least Square Means|136.27|||||TWO_SIDED|90.0|95.38|194.7|||||Treatment H is the reference treatment.|||194.70|95.38|
91680913|NCT02022748|183252714|OTHER||Ratio of Geometric Least Square Means|82.29|||||TWO_SIDED|90.0|68.43|98.96|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||98.96|68.43|
91680914|NCT02022748|183252715|OTHER||Ratio of Geometric Least Square Means|137.75|||||TWO_SIDED|90.0|105.7|179.52|||||Treatment H is the reference treatment.|||179.52|105.70|
91680915|NCT02022748|183252715|OTHER||Ratio of Geometric Least Square Means|148.76|||||TWO_SIDED|90.0|115.07|192.32|||||Treatment H is the reference treatment.|||192.32|115.07|
91680916|NCT02022748|183252715|OTHER||Ratio of Geometric Least Square Means|90.35|||||TWO_SIDED|90.0|77.55|105.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||105.27|77.55|
91680917|NCT02022748|183252716|OTHER||Ratio of Geometric Least Square Means|112.73|||||TWO_SIDED|90.0|88.61|143.42|||||Treatment H is the reference treatment.|||143.42|88.61|
91680918|NCT02022748|183252716|OTHER||Ratio of Geometric Least Square Means|114.37|||||TWO_SIDED|90.0|91.19|143.45|||||Treatment H is the reference treatment.|||143.45|91.19|
91680919|NCT02022748|183252716|OTHER||Ratio of Geometric Least Square Means|93.13|||||TWO_SIDED|90.0|80.31|108.0|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||108.00|80.31|
91680920|NCT02022748|183252717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|90.0|-0.97|0.75|||||Treatment A - Treatment H.|||0.75|-0.97|
91680921|NCT02022748|183252717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|90.0|-0.96|1.52|||||Treatment B - Treatment H.|||1.52|-0.96|
91680922|NCT02022748|183252717|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36|||||TWO_SIDED|90.0|-1.73|1.02|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||1.02|-1.73|
91680923|NCT02022748|183252718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||||TWO_SIDED|90.0|-2.62|0.48|||||Treatment A - Treatment H.|||0.48|-2.62|
91680924|NCT02022748|183252718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|||||TWO_SIDED|90.0|-2.46|0.37|||||Treatment B - Treatment H.|||0.37|-2.46|
91680925|NCT02022748|183252718|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.5|||||TWO_SIDED|90.0|-1.27|0.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||0.27|-1.27|
91680926|NCT06378749|183252731|OTHER|||||||0.029|||||||t-test, 2 sided|||||||.029
91680927|NCT06378749|183252732|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91680928|NCT06378749|183252733|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91680929|NCT06378749|183252734|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91680930|NCT06378749|183252735|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91680931|NCT04663295|183252786|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.3|7.9||One-sided test at significant level of 0.025.|Wilcoxon (Mann-Whitney)|Wilcoxon Signed rank test comparing baseline and study period.||||7.9|3.3|<0.001
91680932|NCT05958888|183252804|SUPERIORITY||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<0.001
91680933|NCT05958888|183252804|SUPERIORITY||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome.The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<0.001
91680934|NCT05958888|183252804|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
91680935|NCT05958888|183252804|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.10
91680936|NCT05958888|183252804|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
91680937|NCT05958888|183252804|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.25|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.25
91680938|NCT05958888|183252805|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
91680939|NCT05958888|183252805|SUPERIORITY||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
91680940|NCT05958888|183252805|SUPERIORITY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
91680941|NCT05958888|183252805|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.85||0.12|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.12
91487289|NCT05055453|182846986|OTHER||||||<|0.001||||||"Result of comparison between preferred app setting and extreme app setting"|Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||< 0.001
91487290|NCT05055453|182846986|OTHER|"Result of comparison between automatic only and extreme app setting."||||||0.002|||||||Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||0.002
91487291|NCT05055453|182846987|OTHER|Analysis of first home trial|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91680942|NCT05958888|183252805|SUPERIORITY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
91680943|NCT05958888|183252805|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.85||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
91680944|NCT05958888|183252806|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||.01
91680945|NCT05958888|183252806|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.23|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||.23
91680946|NCT05958888|183252806|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.01
91680947|NCT05958888|183252806|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.58
91680948|NCT05958888|183252806|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.85|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.85
91680949|NCT05958888|183252806|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.58
91680950|NCT05958888|183252807|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||>.99
91487292|NCT05055453|182846987|OTHER||||||<|0.001|||||||t-test, 2 sided|||Analysis of second home trial||||<.001
91487293|NCT01209923|182846988|OTHER|||||||0.001|||||||t-test, 2 sided|Independent t-test||Children BIA was compared to hydrostatic weighing; adults were compared to DEXA.||||0.001
91487294|NCT02955797|182846996|NON_INFERIORITY|95% confidence interval (CI) was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was greater than (\>) -10%.|Percentage difference|-2.03|||||TWO_SIDED|95.0|-5.84|1.78||||||Serogroup A||1.78|-5.84|
91680951|NCT05958888|183252807|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||>.99
91680952|NCT05958888|183252807|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.47|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.47
91680953|NCT05958888|183252807|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||>.99
91680954|NCT05958888|183252807|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.45|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.45
91718331|NCT01296412|183329430|NON_INFERIORITY_OR_EQUIVALENCE|The sitagliptin-based treatment paradigm was to be declared non-inferior to the liraglutide-based treatment paradigm in lowering A1C at Week 26 if the upper bound of 95% confidence intervals of between group difference was less than the non-inferiority margin of 0.4%.|Difference in least squares mean|0.09|||||TWO_SIDED|95.0|-0.05|0.23|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||0.23|-0.05|
91718332|NCT01296412|183329431|SUPERIORITY_OR_OTHER||Difference in least squares mean|5.9|||||TWO_SIDED|95.0|0.5|11.4|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||11.4|0.5|
91718333|NCT01296412|183329432|SUPERIORITY_OR_OTHER||Difference in percent|-9.5|||||TWO_SIDED|95.0|-17.4|-1.5|||Miettinen & Nurminen|||||-1.5|-17.4|
91718334|NCT01296412|183329433|SUPERIORITY_OR_OTHER||Difference in percent|-4.5|||||TWO_SIDED|95.0|-12.7|3.7|||Miettinen & Nurminen|||||3.7|-12.7|
91718335|NCT02160626|183329434|OTHER|||||||0.0003|||||||ANOVA|||||||0.0003
91718336|NCT02160626|183329434|OTHER|||||||0.0001|||||||ANOVA|||||||.0001
91718337|NCT02160626|183329435|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
91718338|NCT02160626|183329435|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
91718339|NCT02160626|183329436|OTHER|||||||0.0016||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||"Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.~A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site."||||0.0016
91487295|NCT02955797|182846996|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|12.1|||||TWO_SIDED|95.0|8.16|16.1||||||Serogroup C||16.1|8.16|
91718340|NCT02160626|183329436|OTHER|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||||||0.0004||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.0004
91718341|NCT00720278|183329490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_DEVIATION|0.47|<|0.001||95.0|-2.98|-1.14|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.14|-2.98|<0.001
91718342|NCT00720278|183329490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|0.465|<|0.001||95.0|-3.91|-2.09|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-2.09|-3.91|<0.001
91718343|NCT00720278|183329491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|0.479|<|0.001||95.0|-2.72|-0.84|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.84|-2.72|<0.001
91718344|NCT00720278|183329491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.668|STANDARD_DEVIATION|0.4735|<|0.001||95.0|-3.6|-1.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.74|-3.60|<0.001
91718345|NCT00720278|183329492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.376|STANDARD_DEVIATION|0.418||0.001||95.0|-2.2|-0.56|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.56|-2.20|0.001
91718346|NCT00720278|183329492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.432|STANDARD_DEVIATION|0.4145|<|0.001||95.0|-3.24|-1.62|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.62|-3.24|<0.001
91718347|NCT01075048|183329495|SUPERIORITY|||||||0.3815|||||||Log Rank|||||||0.3815
91718348|NCT01075048|183329495|SUPERIORITY|||||||0.19|||||||Peto-Peto-Prentice|||||||0.1900
91718349|NCT01075048|183329495|SUPERIORITY|||||||0.1986|||||||Generalized Wilcoxon|||||||0.1986
91718350|NCT01075048|183329495|SUPERIORITY|||||||0.2617|||||||Tarone-Ware|||||||0.2617
91718351|NCT01075048|183329496|SUPERIORITY|||||||0.4488|||||||Log Rank|||||||0.4488
91718352|NCT01075048|183329496|SUPERIORITY|||||||0.2887|||||||Peto-Peto-Prentice|||||||0.2887
91718353|NCT01075048|183329496|SUPERIORITY|||||||0.1851|||||||Generalized Wilcoxon|||||||0.1851
91718354|NCT01075048|183329496|SUPERIORITY|||||||0.2495|||||||Tarone-Ware|||||||0.2495
91718355|NCT01075048|183329498|SUPERIORITY|||||||0.2804|||||||Log Rank|||OS data cutoff as of 12 Oct 2012||||0.2804
91718356|NCT01075048|183329498|SUPERIORITY|||||||0.2469|||||||Log Rank|||OS data cutoff as of 29 Mar 2013||||0.2469
91718357|NCT01075048|183329498|SUPERIORITY|||||||0.1334|||||||Log Rank|||OS data cutoff as of 25 Jul 2013||||0.1334
91718358|NCT01075048|183329498|SUPERIORITY|||||||0.2159|||||||Log Rank|||OS data cutoff as of 20 Feb 2015||||0.2159
91718359|NCT01677286|183329502|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|171.0||||0.035|TWO_SIDED|95.0|14.1|328.0|||Mixed Models Analysis|degrees of freedom = 12||BNP pg/mL, baseline versus end study values||328|14.1|0.035
91718360|NCT01677286|183329503|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|0.0072||||0.34|TWO_SIDED|95.0|-0.009|0.0234|||Mixed Models Analysis|degrees of freedom = 12||Troponin I ng/mL, baseline versus end study levels.||0.0234|-0.009|0.340
91718361|NCT01677286|183329504|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|-7.39||||0.017|TWO_SIDED|95.0|-13.12|-1.67|||Mixed Models Analysis|degrees of freedom = 10||Creatinine clearance, baseline versus end study levels.||-1.67|-13.12|0.017
91718362|NCT01677286|183329505|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|0.091||||0.603|TWO_SIDED|95.0|-0.285|0.466|||Mixed Models Analysis|degrees of freedom = 10||Proteinuria (g/24 hours), baseline versus end study levels.||0.466|-0.285|0.603
91680955|NCT05958888|183252807|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.7|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.70
91680956|NCT05958888|183252808|SUPERIORITY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
91680957|NCT05958888|183252808|SUPERIORITY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
91680958|NCT05958888|183252808|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
91680959|NCT05958888|183252808|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
91680960|NCT05958888|183252808|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
91680961|NCT05958888|183252808|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.72|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.72
91680962|NCT05958888|183252809|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
91680963|NCT05958888|183252809|SUPERIORITY||Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
91680964|NCT05958888|183252809|SUPERIORITY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
91680965|NCT05958888|183252809|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
91680966|NCT05958888|183252809|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
91680967|NCT05958888|183252809|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
91680968|NCT05958888|183252810|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
91680969|NCT05958888|183252810|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
91680970|NCT05958888|183252810|SUPERIORITY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
91680971|NCT05958888|183252810|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.15||0.43|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.43
91680972|NCT05958888|183252810|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.81
91680973|NCT05958888|183252810|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.81
91680974|NCT00325195|183252811|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91680975|NCT00325195|183252811|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91680976|NCT00325195|183252812|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||Fisher Exact|||||||<0.002
91680977|NCT00325195|183252812|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.200
91718363|NCT00408499|183329506|OTHER|Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.|Maximum tolerated dose|4.0|||||TWO_SIDED||||||||Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab|||||
91718364|NCT04596293|183329510|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91718365|NCT04596293|183329510|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91718366|NCT04596293|183329511|OTHER|||||||0.6351|||||||Fisher Exact|||||||0.6351
91718367|NCT04596293|183329511|OTHER|||||||0.3108|||||||Fisher Exact|||||||0.3108
91718368|NCT04596293|183329512|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91526845|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.29||||0.119|TWO_SIDED|95.0|-0.07|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.07|0.119
91718369|NCT04596293|183329512|OTHER|||||||0.6594|||||||Fisher Exact|||||||0.6594
91718370|NCT04596293|183329513|OTHER|||||||0.5808|||||||ANCOVA|||||||0.5808
91718371|NCT04596293|183329513|OTHER|||||||0.2143|||||||ANCOVA|||||||0.2143
91718372|NCT01258374|183329522|OTHER||||||<|0.01||||||The PK paramaters reported as geometric means, were calculated using noncompartmental modelinf techniques (WinNolin; Pharsight Corporation, Mountain View, CA)|Noncompartmental modeling techniques||||The pharmacokinetic parameters calculated for DRV, RTV and RAL were trough plasma concentration (C trough), defined as the concentration at 24 or 12 h after observed dose, the maximum observed plasma concentration (C max), the area under the plasma concentration-time curve from 0 to 24 H (AUC 0-24) or 0 to 12 h (AUC 0-12) and the elimination half-life (t1/2). AUC and t1/2 were calculated using non using noncompartmental modeling techniques (WinNolin; Pharsight Corporation, Mountain View, CA). All of these PK parameters are reported as geometric means.|||<0.01
91718373|NCT01125930|183329567|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.93
91680978|NCT00325195|183252813|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Fisher Exact|||% of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.007
91680979|NCT00325195|183252813|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Fisher Exact|||% of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.321
91680980|NCT00325195|183252814|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||t-test, 2 sided|||||||0.166
91680981|NCT00325195|183252814|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||||||0.170
91718374|NCT01125930|183329568|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.79
91680982|NCT00325195|183252815|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
91680983|NCT00325195|183252815|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
91680984|NCT03469336|183252882|OTHER|Ratio|Mean Ratio (Test/Reference)|1.0109|STANDARD_ERROR_OF_MEAN|0.732||0.9883|TWO_SIDED|95.0|0.2364|4.3226|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.3226|0.2364|0.9883
91680985|NCT03469336|183252882|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.732||0.9977|TWO_SIDED|95.0|0.2334|4.2671|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.2671|0.2334|0.9977
91680986|NCT03469336|183252882|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1382|STANDARD_ERROR_OF_MEAN|0.732||0.86|TWO_SIDED|95.0|0.2662|4.867|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.8670|0.2662|0.8600
91680987|NCT03469336|183252887|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.071||0.9763|TWO_SIDED|95.0|0.8588|1.1594|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.1594|0.8588|0.9763
91680988|NCT03469336|183252887|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9664|STANDARD_ERROR_OF_MEAN|0.051||0.5081|TWO_SIDED|95.0|0.8686|1.0752|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.0752|0.8686|0.5081
91680989|NCT03469336|183252887|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1155|STANDARD_ERROR_OF_MEAN|0.044||0.0249|TWO_SIDED|95.0|1.0157|1.2252|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.2252|1.0157|0.0249
91718375|NCT01125930|183329569|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.94
91718376|NCT01125930|183329569|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.57
91680990|NCT03469336|183252888|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7946|STANDARD_ERROR_OF_MEAN|0.732||0.754|TWO_SIDED|95.0|0.1858|3.3977|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3977|0.1858|0.7540
91680991|NCT03469336|183252888|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7844|STANDARD_ERROR_OF_MEAN|0.732||0.7407|TWO_SIDED|95.0|0.1834|3.354|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3540|0.1834|0.7407
91680992|NCT03469336|183252888|OTHER|Ratio|Mean Ratio (Test/Reference)|0.8946|STANDARD_ERROR_OF_MEAN|0.732||0.8793|TWO_SIDED|95.0|0.2092|3.8256|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.8256|0.2092|0.8793
91680993|NCT03469336|183252889|OTHER|Ratio|Mean Ratio (Test/Reference)|1.081321|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.25287|4.623941|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.623941|0.25287|<0.0001
91680994|NCT03469336|183252889|OTHER|Ratio|Mean Ratio (Test/Reference)|1.067453|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.249631|4.564555|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.564555|0.249631|<0.0001
91680995|NCT03469336|183252889|OTHER|Ratio|Mean Ratio (Test/Reference)|1.217483|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.284708|5.206258|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||5.206258|0.284708|<0.0001
91680996|NCT02740699|183252915|SUPERIORITY|||||||0.0256|||||||Wilcoxon Signed Rank Tests|||||||0.0256
91680997|NCT02740699|183252916|SUPERIORITY|||||||0.0254|||||||Wilcoxon Signed Rank Tests|||||||0.0254
91680998|NCT02740699|183252917|SUPERIORITY|||||||0.58|||||||Regression, Linear|||||||0.58
91680999|NCT02740699|183252918|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
91681000|NCT02740699|183252919|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
91681001|NCT02740699|183252920|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
91681002|NCT02393248|183252933|SUPERIORITY|||||||0.2841|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2841
91681003|NCT02393248|183252933|SUPERIORITY|||||||0.3042|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.3042
91681004|NCT02393248|183252933|SUPERIORITY|||||||0.1259|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1259
91681005|NCT02393248|183252933|SUPERIORITY|||||||0.8214|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8214
91681006|NCT02393248|183252933|SUPERIORITY|||||||0.4315|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.4315
91681007|NCT02393248|183252933|SUPERIORITY|||||||0.2595|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2595
91681008|NCT02393248|183252937|SUPERIORITY|||||||0.8577|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8577
91681009|NCT02393248|183252937|SUPERIORITY|||||||0.7238|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7238
91681010|NCT02393248|183252937|SUPERIORITY|||||||0.5923|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5923
91718377|NCT01125930|183329569|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
91681011|NCT02393248|183252937|SUPERIORITY|||||||0.7634|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7634
91681012|NCT02393248|183252937|SUPERIORITY|||||||0.5749|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5749
91681013|NCT02393248|183252937|SUPERIORITY|||||||0.6877|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6877
91681014|NCT02393248|183252941|SUPERIORITY|||||||0.143|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.143
91681015|NCT02393248|183252942|SUPERIORITY|||||||0.0013|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.0013
91681016|NCT02393248|183252943|SUPERIORITY|||||||0.319|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.319
91681017|NCT02393248|183252944|SUPERIORITY|||||||0.128|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.128
91681018|NCT02393248|183252945|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
91681019|NCT02393248|183252946|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
91681020|NCT02393248|183252947|SUPERIORITY|||||||0.772|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.772
91681021|NCT02585934|183252960|SUPERIORITY||least square mean difference|-0.36||||0.2249|TWO_SIDED|95.0|-0.95|0.22||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.22|-0.95|0.2249
91681022|NCT02585934|183252961|SUPERIORITY||least square mean difference|-0.09||||0.826|TWO_SIDED|95.0|-0.9|0.72||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.72|-0.90|0.8260
91681023|NCT02585934|183252962|SUPERIORITY||least square mean difference|-0.12||||0.0234|TWO_SIDED|95.0|-0.22|-0.02||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||-0.02|-0.22|0.0234
91681024|NCT02585934|183252963|SUPERIORITY||least square mean difference|0.12||||0.2096|TWO_SIDED|95.0|-0.07|0.32||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.32|-0.07|0.2096
91681025|NCT02585934|183252964|SUPERIORITY||least square mean difference|-0.14||||0.765|TWO_SIDED|95.0|-1.09|0.8||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.80|-1.09|0.7650
91681026|NCT02585934|183252965|SUPERIORITY||least square mean difference|-0.38||||0.2472|TWO_SIDED|95.0|-1.03|0.27||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.27|-1.03|0.2472
91681027|NCT00593736|183252985|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.||||0.646
91681028|NCT00593736|183252985|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.084
91681029|NCT00593736|183252985|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.929
91681030|NCT00593736|183252986|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.854
91681031|NCT00593736|183252986|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.383
91681032|NCT00593736|183252986|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.883
91681033|NCT00593736|183252987|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
91681034|NCT00593736|183252987|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
91681035|NCT00593736|183252987|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.269
91681036|NCT00593736|183252988|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.920
91681037|NCT00593736|183252988|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.382
91681038|NCT00593736|183252988|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.439
91681039|NCT00593736|183252989|SUPERIORITY_OR_OTHER|||||||0.973||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.973
91681040|NCT00593736|183252989|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
91681041|NCT00593736|183252989|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.816
91681042|NCT00593736|183252990|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.661
91681043|NCT00593736|183252990|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.341
91681044|NCT00593736|183252990|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
91487296|NCT02955797|182846996|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|2.42|||||TWO_SIDED|95.0|-1.34|6.19||||||Serogroup Y||6.19|-1.34|
91681045|NCT00593736|183252991|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
91681046|NCT00593736|183252991|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
91681047|NCT00593736|183252991|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.268
91681048|NCT00593736|183252992|SUPERIORITY_OR_OTHER|||||||0.9||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.900
91681049|NCT00593736|183252992|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.525
91681050|NCT00593736|183252992|SUPERIORITY_OR_OTHER|||||||0.418||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.418
91681051|NCT00593736|183252993|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.051
91681052|NCT00593736|183252993|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.926
91681053|NCT00593736|183252993|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.166
91718378|NCT01125930|183329569|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.38
91681054|NCT00593736|183252994|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.511
91681055|NCT00593736|183252994|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
91681056|NCT00593736|183252994|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.188
91681057|NCT00593736|183252995|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.691
91681058|NCT00593736|183252995|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.323
91681059|NCT00593736|183252995|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.324
91681060|NCT00593736|183252996|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.197
91681061|NCT00593736|183252996|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.871
91681062|NCT00593736|183252996|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.737
91681063|NCT00593736|183252997|SUPERIORITY_OR_OTHER|||||||0.972||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.972
91681064|NCT00593736|183252997|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
91681065|NCT00593736|183252997|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.811
91681066|NCT00593736|183252998|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.659
91681067|NCT00593736|183252998|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.337
91681068|NCT00593736|183252998|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
91681069|NCT00593736|183252999|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
91681070|NCT00593736|183252999|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.495
91718379|NCT01125930|183329569|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.24
91718380|NCT01125930|183329570|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.||||0.87
91681071|NCT00593736|183252999|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.800
91681072|NCT00593736|183253000|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
91681073|NCT00593736|183253000|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.134
91681074|NCT00593736|183253000|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.130
91681075|NCT00593736|183253001|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.063
91681076|NCT00593736|183253001|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
91681077|NCT00593736|183253001|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.521
91681078|NCT00593736|183253002|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.675
91718381|NCT01125930|183329571|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.||||1.00
91681079|NCT00593736|183253002|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
91681080|NCT00593736|183253002|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.205
91681081|NCT00593736|183253003|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.643
91681082|NCT00593736|183253003|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.032
91681083|NCT00593736|183253003|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.875
91681084|NCT00593736|183253004|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.286
91681085|NCT00593736|183253004|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.318
91681086|NCT00593736|183253004|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.483
91681087|NCT00593736|183253005|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.040
91681088|NCT00593736|183253005|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.610
91681089|NCT00593736|183253005|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.368
91681090|NCT00593736|183253006|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.352
91681091|NCT00593736|183253006|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
91681092|NCT00593736|183253006|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.297
91681093|NCT00593736|183253007|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.053
91681094|NCT00593736|183253007|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
91681095|NCT00593736|183253007|SUPERIORITY_OR_OTHER|||||||0.783||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.783
91681096|NCT00593736|183253008|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
91681097|NCT00593736|183253008|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.543
91681098|NCT00593736|183253008|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.847
91681099|NCT00593736|183253009|SUPERIORITY_OR_OTHER|||||||0.356||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.356
91681100|NCT00593736|183253009|SUPERIORITY_OR_OTHER|||||||0.964||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.964
91681101|NCT00593736|183253009|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.799
91681102|NCT00593736|183253010|SUPERIORITY_OR_OTHER|||||||0.698||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.698
91681103|NCT00593736|183253010|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.385
91681104|NCT00593736|183253010|SUPERIORITY_OR_OTHER|||||||0.641||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.641
91681105|NCT00593736|183253011|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.979
91681106|NCT00593736|183253011|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
91527597|NCT01976364|182930475|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
91681107|NCT00593736|183253011|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
91681108|NCT00593736|183253012|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.975
91681109|NCT00593736|183253012|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.639
91681110|NCT00593736|183253012|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.109
91681111|NCT00593736|183253013|SUPERIORITY_OR_OTHER|||||||0.823||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.823
91681112|NCT00593736|183253013|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
91681113|NCT00593736|183253013|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.296
91681114|NCT00593736|183253014|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.092
91681115|NCT00593736|183253014|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.025
91681116|NCT00593736|183253014|SUPERIORITY_OR_OTHER|||||||0.732||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.732
91681117|NCT00593736|183253015|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.298
91718382|NCT01125930|183329571|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.62
91681118|NCT00593736|183253015|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.276
91681119|NCT00593736|183253015|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.430
91681120|NCT00593736|183253016|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.349
91681121|NCT00593736|183253016|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.203
91681122|NCT00593736|183253016|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.444
91681123|NCT00593736|183253017|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.581
91681124|NCT00593736|183253017|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.257
91681125|NCT00593736|183253017|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.688
91681126|NCT00593736|183253018|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.561
91681127|NCT00593736|183253018|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.595
91681128|NCT00593736|183253018|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.795
91681129|NCT00593736|183253019|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
91526846|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.25|0.28|0.002
91681130|NCT00593736|183253019|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.177
91681131|NCT00593736|183253019|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.044
91681132|NCT00593736|183253020|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.475
91681133|NCT00593736|183253020|SUPERIORITY_OR_OTHER|||||||0.635||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.635
91718383|NCT01125930|183329571|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
91681134|NCT00593736|183253020|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.782
91487297|NCT02955797|182846996|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.458|||||TWO_SIDED|95.0|-4.37|5.28||||||Serogroup W||5.28|-4.37|
91487298|NCT02955797|182846997|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.3|||||TWO_SIDED|95.0|-3.6|6.2||||||Serogroup A||6.2|-3.6|
91681135|NCT00593736|183253021|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.192
91681136|NCT00593736|183253021|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.618
91681137|NCT00593736|183253021|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.152
91681138|NCT00593736|183253022|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.379
91681139|NCT00593736|183253022|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.057
91681140|NCT00593736|183253022|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.808
91681141|NCT00593736|183253023|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.284
91681142|NCT00593736|183253023|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.344
91681143|NCT00593736|183253023|SUPERIORITY_OR_OTHER|||||||0.558||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.558
91681144|NCT00593736|183253024|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.867
91487299|NCT02955797|182846997|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|18.0|||||TWO_SIDED|95.0|13.6|22.8||||||Serogroup C||22.8|13.6|
91681145|NCT00593736|183253024|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.244
91681146|NCT00593736|183253024|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.620
91681147|NCT00593736|183253025|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
91681148|NCT00593736|183253025|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.559
91681149|NCT00593736|183253025|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.074
91487300|NCT02955797|182846997|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.6|||||TWO_SIDED|95.0|-2.76|6.03||||||Serogroup Y||6.03|-2.76|
91681150|NCT00593736|183253026|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.796
91681151|NCT00593736|183253026|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.546
91681152|NCT00593736|183253026|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.479
91681153|NCT00593736|183253027|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.766
91681154|NCT00593736|183253027|SUPERIORITY_OR_OTHER|||||||0.912||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.912
91681155|NCT00593736|183253027|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.952
91681156|NCT00593736|183253028|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.722
91681157|NCT00593736|183253028|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.262
91681158|NCT00593736|183253028|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.717
91681159|NCT00593736|183253029|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.498
91681160|NCT00593736|183253029|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.664
91681161|NCT00593736|183253029|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.428
91681162|NCT00593736|183253030|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.519
91527598|NCT01976364|182930475|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
91681163|NCT00593736|183253030|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.179
91681164|NCT00593736|183253030|SUPERIORITY_OR_OTHER|||||||0.935||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.935
91681165|NCT00593736|183253031|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.425
91681166|NCT00593736|183253031|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.406
91681167|NCT00593736|183253031|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.720
91681168|NCT00593736|183253032|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.294
91681169|NCT00593736|183253032|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.474
91681170|NCT00593736|183253032|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.999
91681171|NCT00593736|183253033|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
91681172|NCT00593736|183253033|SUPERIORITY_OR_OTHER|||||||0.331||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.331
91681173|NCT00593736|183253033|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.362
91681174|NCT00593736|183253034|SUPERIORITY_OR_OTHER|||||||0.684||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.684
91681175|NCT00593736|183253034|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.399
91681176|NCT00593736|183253034|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.611
91681177|NCT00593736|183253035|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.157
91681178|NCT00593736|183253035|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.463
91681179|NCT00593736|183253035|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.774
91681180|NCT00593736|183253036|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.413
91681181|NCT00593736|183253036|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.093
91681182|NCT00593736|183253036|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.982
91718384|NCT01125930|183329571|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
91681183|NCT00593736|183253037|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.441
91681184|NCT00593736|183253037|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
91681185|NCT00593736|183253037|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.549
91681186|NCT00593736|183253038|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
91681187|NCT00593736|183253038|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.997
91681188|NCT00593736|183253038|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.834
91718385|NCT01125930|183329571|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.45
91487301|NCT02955797|182846997|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.2|||||TWO_SIDED|95.0|-5.85|6.18||||||Serogroup W||6.18|-5.85|
91681189|NCT00593736|183253039|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
91681190|NCT00593736|183253039|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.321
91681191|NCT00593736|183253039|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.978
91681192|NCT00593736|183253040|SUPERIORITY_OR_OTHER|||||||0.513||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.513
91681193|NCT00593736|183253040|SUPERIORITY_OR_OTHER|||||||0.751||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.751
91681194|NCT00593736|183253040|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.242
91681195|NCT00593736|183253041|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.307
91681196|NCT00593736|183253041|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.765
91681197|NCT00593736|183253041|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.727
91681198|NCT00593736|183253042|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.902
91681199|NCT00593736|183253042|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.590
91681200|NCT00593736|183253042|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.290
91681201|NCT00593736|183253043|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.685
91681202|NCT00593736|183253043|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.214
91681203|NCT00593736|183253043|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.055
91681204|NCT00593736|183253044|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.589
91681205|NCT00593736|183253044|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
91681206|NCT00593736|183253044|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.041
91487302|NCT02955797|182846998|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an analysis of variance (ANOVA) model of log10-transformed titers.|GMT Ratio|0.819|||||TWO_SIDED|95.0|0.697|0.963||||||Serogroup A||0.963|0.697|
91718386|NCT01125930|183329572|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
91718387|NCT01125930|183329572|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
91681207|NCT01853930|183253049|SUPERIORITY|The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option.||||||0.876|||||||t-test, 2 sided|t= -0.157 df= 30||||||0.876
91681208|NCT00110136|183253077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_DEVIATION|2.02||0.2629|TWO_SIDED|95.0|-2.36|0.74||Paired t-test; no adjustments for multiple comparisons|paired t-test||The difference is post minus pre so negative values represents fewer hot flashes after treatment.|Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.||0.74|-2.36|0.2629
91681209|NCT00110136|183253078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.37|STANDARD_DEVIATION|7.91||0.1365|TWO_SIDED|95.0|-10.45|1.72||Paired t-test; unadjusted for multiple comparisons.|paired t-test||Difference in hot flash score is post minus pre so a negative value represents a decrease in the frequency and/or severity of the hot flashes.|Assessment of the change in the hot flash score over time||1.72|-10.45|0.1365
91681210|NCT00110136|183253080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|7.0||0.832|TWO_SIDED|95.0|-4.84|5.92||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in MCS from baseline to four weeks (post minus pre) so values greater than zero reflect improvement in QOL.|Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.||5.92|-4.84|0.8320
91681211|NCT00110136|183253081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.43||0.9995|TWO_SIDED|95.0|-5.71|5.71||Paired t-test on the change in PCS from baseline to four weeks; unadjusted for multiple comparisons.|paired t-test||This is the change in PCS from baseline to four weeks (post minus pre), so positive numbers represent improvement in QOL.|Assess the change in PCS from baseline to four weeks; null hypothesis is no change.||5.71|-5.71|0.9995
91681212|NCT00110136|183253082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.35|STANDARD_DEVIATION|7.12||0.1042|TWO_SIDED|95.0|-1.12|9.822||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in mood from baseline to four weeks (post minus pre). Mood is scored so that higher numbers represent better mood so positive changes represent an improvement in mood.|Assess the change in mood from baseline to four weeks. Null hypothesis is no change.||9.822|-1.12|0.1042
91681213|NCT02737748|183253103|OTHER|||||||0.2217|||||||Cochran-Mantel-Haenszel|||||||0.2217
91681214|NCT02737748|183253104|OTHER|||||||0.0324|||||||Cochran-Mantel-Haenszel|||||||0.0324
91681215|NCT02737748|183253105|OTHER|||||||0.3975|||||||Log Rank|||||||0.3975
91681216|NCT06354998|183253155|OTHER||Geometric Mean Ratio (GMR)|0.908|||||TWO_SIDED|95.0|0.662|1.245|||||GMR was a secondary endpoint.|GMR (mRNA-1273.815 versus licensed Spikevax) at Day 15 and its 95% CI was calculated based on the t-distribution for the mean difference of log-transformed antibody values and then back transformed to the original scale for presentation.||1.245|0.662|
91681217|NCT01791153|183253253|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|42.0|||<|0.0001|TWO_SIDED|99.5|18.0|66.0|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to \[\</=\] 30 mg/day, greater than \[\>\] 30 mg/day).||66.00|18.00|<0.0001
91681218|NCT01791153|183253253|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|39.06|||<|0.0001|TWO_SIDED|99.5|12.46|65.66|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||65.66|12.46|< 0.0001
91681219|NCT01791153|183253254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||< 0.0001
91681220|NCT01791153|183253254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|38.35|||||TWO_SIDED|99.5|17.89|58.81||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||58.81|17.89|
91681221|NCT01791153|183253254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||0.0002
91681222|NCT01791153|183253254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|35.41|||||TWO_SIDED|99.5|10.41|60.41||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||60.41|10.41|
91681223|NCT01791153|183253255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|99.0|0.11|0.46|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.46|0.11|<0.0001
91681224|NCT01791153|183253255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39||||0.0011|TWO_SIDED|99.0|0.18|0.82|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.82|0.18|0.0011
91681225|NCT01791153|183253255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.0001|TWO_SIDED|99.0|0.12|0.66|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.66|0.12|0.0001
91681226|NCT01791153|183253255|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.0316|TWO_SIDED|99.0|0.2|1.16|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||1.16|0.20|0.0316
91681227|NCT01791153|183253256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
91681228|NCT01791153|183253256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
91681229|NCT01791153|183253256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30mg/day, \>30mg/day).||||0.0003
91681230|NCT01791153|183253256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
91681231|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|0.61||||0.8067|TWO_SIDED|99.0|-5.86|7.07|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||7.07|-5.86|0.8067
91681232|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.44||||0.0252|TWO_SIDED|99.0|-0.69|9.56|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.56|-0.69|0.0252
91681233|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-0.56||||0.8374|TWO_SIDED|99.0|-7.64|6.53|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||6.53|-7.64|0.8374
91681234|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.27||||0.1468|TWO_SIDED|99.0|-2.59|9.14|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.14|-2.59|0.1468
91681235|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.38||||0.057|TWO_SIDED|99.0|-1.58|10.34|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.34|-1.58|0.0570
91681236|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|5.59||||0.0024|TWO_SIDED|99.0|0.86|10.32|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.32|0.86|0.0024
91681237|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.04||||0.2218|TWO_SIDED|99.0|-3.43|9.51|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.51|-3.43|0.2218
91681238|NCT01791153|183253257|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.25||||0.0412|TWO_SIDED|99.0|-1.14|9.64|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.64|-1.14|0.0412
91681239|NCT01791153|183253258|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-15.6||||0.0312|TWO_SIDED|99.0|-34.3|3.1|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.1|-34.3|0.0312
91681240|NCT01791153|183253258|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-11.8||||0.0476|TWO_SIDED|99.0|-27.2|3.6|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.6|-27.2|0.0476
91681241|NCT01791153|183253258|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-21.9||||0.0059|TWO_SIDED|99.0|-42.4|-1.4|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-1.4|-42.4|0.0059
91681242|NCT01791153|183253258|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-18.2||||0.0081|TWO_SIDED|99.0|-35.8|-0.5|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-0.5|-35.8|0.0081
91681243|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.11|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.09|-0.11|
91681244|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.38|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.38|
91681245|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.37|-0.16|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.16|-0.37|
91681246|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.3|||||TWO_SIDED|95.0|0.13|0.46|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.46|0.13|
91681247|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.29|-0.04|
91681248|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.17|||||TWO_SIDED|95.0|-0.33|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||-0.01|-0.33|
91681249|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
91681250|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
91681251|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.10|-0.10|
91681252|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.09|-0.15|
91681253|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.16|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.16|
91681254|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.11|-0.13|
91681255|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.13|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.07|-0.13|
91527599|NCT01976364|182930475|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.1|
91681256|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.23|-0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.03|-0.23|
91681257|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.1|||||TWO_SIDED|95.0|-0.2|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.00|-0.20|
91681258|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.22|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.01|-0.22|
91681259|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.34|||||TWO_SIDED|95.0|-0.44|-0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.23|-0.44|
91681260|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.22|||||TWO_SIDED|95.0|-0.33|-0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.11|-0.33|
91681261|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.16|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.16|
91681262|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.04|0.31|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.31|0.04|
91681263|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.2|||||TWO_SIDED|95.0|0.07|0.34|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.34|0.07|
91681264|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.23|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.01|-0.23|
91681265|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.16|||||TWO_SIDED|95.0|-0.28|-0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||-0.04|-0.28|
91526847|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.061|TWO_SIDED|95.0|-0.02|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|-0.02|0.061
91681266|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.17|
91681267|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
91681268|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.18|||||TWO_SIDED|95.0|-0.28|-0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.07|-0.28|
91681269|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
91681270|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.25|||||TWO_SIDED|95.0|0.13|0.37|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.37|0.13|
91681271|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.12|0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.12|-0.12|
91681272|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.25|||||TWO_SIDED|95.0|-0.37|-0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||-0.13|-0.37|
91681273|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.14|||||TWO_SIDED|95.0|0.02|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.25|0.02|
91681274|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.01|0.24|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.24|0.01|
91681275|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.11|-0.13|
91681276|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.09|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.10|-0.09|
91681277|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.14|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.14|
91487303|NCT02955797|182846998|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|7.59|||||TWO_SIDED|95.0|6.05|9.52||||||Serogroup C||9.52|6.05|
91681278|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.15|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.15|
91681279|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.19|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.03|-0.19|
91681280|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.12|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.09|-0.12|
91681281|NCT00444457|183253329|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.05|0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.17|-0.05|
91681282|NCT00444457|183253330|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.1|||||TWO_SIDED|95.0|-3.3|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-3.3|
91681283|NCT00444457|183253331|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-2.1|
91681284|NCT00444457|183253331|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.6|||||TWO_SIDED|95.0|-3.4|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-3.4|
91681285|NCT00444457|183253331|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.5|||||TWO_SIDED|95.0|-1.5|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-1.5|
91681286|NCT00444457|183253332|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.4|2.2|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.2|-2.4|
91681287|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.0|||||TWO_SIDED|95.0|-0.51|4.75||||||Common serotypes - serotype 4||4.75|-0.51|
91681288|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.09|1.1||||||Common serotypes - serotype 4||1.10|-3.09|
91487304|NCT02955797|182846998|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Serogroup Y||1.51|1.09|
91487305|NCT02955797|182846998|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.32|||||TWO_SIDED|95.0|1.12|1.56||||||Serogroup W||1.56|1.12|
91681289|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.9|||||TWO_SIDED|95.0|-5.58|-0.58||||||Common serotypes - serotype 4||-0.58|-5.58|
91681290|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|5.3|||||TWO_SIDED|95.0|1.55|9.19||||||Common serotypes - serotype 6B||9.19|1.55|
91681291|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.4|||||TWO_SIDED|95.0|-2.77|3.66||||||Common serotypes - serotype 6B||3.66|-2.77|
91681292|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.9|||||TWO_SIDED|95.0|-8.82|-1.1||||||Common serotypes - serotype 6B||-1.10|-8.82|
91681293|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.13|2.83||||||Common serotypes - serotype 9V||2.83|-3.13|
91681294|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.1|||||TWO_SIDED|95.0|-3.97|1.73||||||Common serotypes - serotype 9V||1.73|-3.97|
91681295|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.81|1.88||||||Common serotypes - serotype 9V||1.88|-3.81|
91681296|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.27|1.95||||||Common serotypes - serotype 14||1.95|-1.27|
91681297|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.1|||||TWO_SIDED|95.0|-0.6|3.01||||||Common serotypes - serotype 14||3.01|-0.60|
91681298|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.04|2.76||||||Common serotypes - serotype 14||2.76|-1.04|
91681299|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.1|||||TWO_SIDED|95.0|-0.38|4.74||||||Common serotypes - serotype 18C||4.74|-0.38|
91681300|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.33|1.99||||||Common serotypes - serotype 18C||1.99|-2.33|
91681301|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.2|||||TWO_SIDED|95.0|-4.89|0.23||||||Common serotypes - serotype 18C||0.23|-4.89|
91681302|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.93|2.6||||||Common serotypes - serotype 19F||2.60|-1.93|
91526848|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.3||||0.131|TWO_SIDED|95.0|-0.09|0.7||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.70|-0.09|0.131
91527600|NCT01976364|182930475|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.6|
91681303|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.46|0.28||||||Common serotypes - serotype 19F||0.28|-3.46|
91681304|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.8|||||TWO_SIDED|95.0|-3.87|0.02||||||Common serotypes - serotype 19F||0.02|-3.87|
91681305|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.2|||||TWO_SIDED|95.0|-1.03|7.46||||||Common serotypes - serotype 23F||7.46|-1.03|
91718388|NCT01125930|183329572|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
91681306|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|4.0|||||TWO_SIDED|95.0|-0.27|8.39||||||Common serotypes - serotype 23F||8.39|-0.27|
91681307|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-3.75|5.46||||||Common serotypes - serotype 23F||5.46|-3.75|
91681308|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.48|3.18||||||Additional serotypes - serotype 1||3.18|-1.48|
91681309|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.78|1.34||||||Additional serotypes - serotype 1||1.34|-2.78|
91681310|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.77|0.67||||||Additional serotypes - serotype 1||0.67|-3.77|
91681311|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-3.9|||||TWO_SIDED|95.0|-10.27|2.45||||||Additional serotypes - serotype 3||2.45|-10.27|
91681312|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-10.7|||||TWO_SIDED|95.0|-16.8|-4.57||||||Additional serotypes - serotype 3||-4.57|-16.80|
91681313|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-6.8|||||TWO_SIDED|95.0|-12.76|-0.74||||||Additional serotypes - serotype 3||-0.74|-12.76|
91681314|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.9|||||TWO_SIDED|95.0|0.15|7.69||||||Additional serotypes - serotype 5||7.69|0.15|
91681315|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.52|3.09||||||Additional serotypes - serotype 5||3.09|-3.52|
91681316|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.1|||||TWO_SIDED|95.0|-7.92|-0.36||||||Additional serotypes - serotype 5||-0.36|-7.92|
91681317|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.5|||||TWO_SIDED|95.0|0.12|5.23||||||Additional serotypes - serotype 6A||5.23|0.12|
91681318|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.22|1.86||||||Additional serotypes - serotype 6A||1.86|-2.22|
91681319|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.7|||||TWO_SIDED|95.0|-5.39|-0.27||||||Additional serotypes - serotype 6A||-0.27|-5.39|
91681320|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-0.47|2.3||||||Additional serotypes - serotype 7F||2.30|-0.47|
91681321|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-1.12|1.18||||||Additional serotypes - serotype 7F||1.18|-1.12|
91681322|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.3|0.52||||||Additional serotypes - serotype 7F||0.52|-2.30|
91681323|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.0|||||TWO_SIDED|95.0|-2.91|0.8||||||Additional serotypes - serotype 19A||0.80|-2.91|
91681324|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.69|1.19||||||Additional serotypes - serotype 19A||1.19|-2.69|
91487306|NCT02955797|182846999|OTHER||GMT Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.24||||||Serogroup A||1.24|0.85|
91487307|NCT02955797|182846999|OTHER||GMT Ratio|16.5|||||TWO_SIDED|95.0|13.4|20.4||||||Serogroup C||20.4|13.4|
91487308|NCT02955797|182846999|OTHER||GMT Ratio|1.18|||||TWO_SIDED|95.0|0.97|1.44||||||Serogroup Y||1.44|0.97|
91681325|NCT00444457|183253333|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.4|2.04||||||Additional serotypes - serotype 19A||2.04|-1.40|
91681326|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.1|||||TWO_SIDED|95.0|-1.61|1.81|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||1.81|-1.61|
91681327|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-2.39|0.23|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.23|-2.39|
91681328|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.54|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.20|-2.54|
91681329|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.02|1.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.11|-1.02|
91681330|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.04|-1.03|
91681331|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.13|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.13|
91681332|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.25|1.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.37|-1.25|
91681333|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.76|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.76|
91681334|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-0.87|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.87|
91681335|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.74|1.62|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.62|-0.74|
91487309|NCT02955797|182846999|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.1|1.63||||||Serogroup W||1.63|1.1|
91487310|NCT02955797|182847000|OTHER||GMT Ratio|0.496|||||TWO_SIDED|95.0|0.367|0.672||||||Serogroup A||0.672|0.367|
91487311|NCT02955797|182847000|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|0.814|2.19||||||Serogroup C||2.19|0.814|
91487312|NCT02955797|182847000|OTHER||GMT Ratio|1.53|||||TWO_SIDED|95.0|1.15|2.04||||||Serogroup Y||2.04|1.15|
91487313|NCT02955797|182847000|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|0.944|1.75||||||Serogroup W||1.75|0.944|
91487314|NCT01739361|182847053|SUPERIORITY_OR_OTHER|||||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
91487315|NCT05535972|182847056|OTHER||Least Square Mean|-6.81|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-7.28|-6.33|||||CFB in CAT score was analyzed using Mixed Model Repeated Measures(MMRM) model with covariates of smoking status, CAT score at Baseline, visit, interaction of CAT score at Baseline\*visit. Estimates derived from inverse probability weighted MMRM model.|||-6.33|-7.28|
91487316|NCT04590963|182847073|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.989|TWO_SIDED|95.0|0.66|1.537|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.537|0.660|0.989
91681336|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.04|-1.03|
91681337|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.61|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||0.76|-1.61|
91681338|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.4|||||TWO_SIDED|95.0|-1.52|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||2.39|-1.52|
91681339|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||1.04|-2.30|
91681340|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.87|0.74|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.74|-2.87|
91718389|NCT01125930|183329572|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
91487317|NCT04590963|182847074|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.704|1.528|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.528|0.704|0.891
91487318|NCT04590963|182847075|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.574|TWO_SIDED|95.0|0.79|1.568|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.568|0.790|0.574
91487319|NCT04590963|182847076|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.53|TWO_SIDED|95.0|0.818|1.512|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.512|0.818|0.530
91681341|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.55|1.5|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.50|-2.55|
91681342|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.1|||||TWO_SIDED|95.0|-3.06|0.57|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.57|-3.06|
91681343|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.44|1.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.00|-2.44|
91681344|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.21|2.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.05|-1.21|
91681345|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.1|||||TWO_SIDED|95.0|-0.52|3.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||3.16|-0.52|
91681346|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-1.05|2.87|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.87|-1.05|
91487320|NCT04590963|182847077|SUPERIORITY||Odds Ratio (OR)|0.56||||0.115|TWO_SIDED|95.0|0.274|1.154|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.154|0.274|0.115
91681347|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.17|2.53|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.53|-0.17|
91681348|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-0.2|2.44|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.44|-0.20|
91681349|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.79|1.66|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.66|-1.79|
91681350|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|2.8|||||TWO_SIDED|95.0|-2.85|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-2.85|
91681351|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.9|||||TWO_SIDED|95.0|-9.99|0.21|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.21|-9.99|
91681352|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-7.7|||||TWO_SIDED|95.0|-13.14|-2.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||-2.37|-13.14|
91718390|NCT01125930|183329572|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||1.00
91718391|NCT01125930|183329573|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
91718392|NCT01125930|183329573|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.41
91718393|NCT01125930|183329573|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
91718394|NCT01125930|183329573|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.92
91718395|NCT01125930|183329573|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.80
91718396|NCT01125930|183329574|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TAC1 at Week 24 visit were made using fold change data.||||0.003
91487321|NCT04590963|182847078|SUPERIORITY||Odds Ratio (OR)|0.6||||0.162|TWO_SIDED|95.0|0.297|1.231|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for HPV Status, WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.231|0.297|0.162
91718397|NCT01125930|183329574|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCR4 at Week 24 visit were made using fold change data.||||0.35
91718398|NCT01125930|183329574|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCL12 at Week 24 visit were made using fold change data.||||0.68
91718399|NCT01125930|183329574|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TNFa at Week 24 visit were made using fold change data.||||0.76
91718400|NCT01125930|183329575|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-1 at Week 24 visit were made using fold change data.||||1.00
91718401|NCT01125930|183329575|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-3 at Week 24 visit were made using fold change data.||||0.25
91718402|NCT01125930|183329575|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-1 at Week 24 visit were made using fold change data.||||0.41
91718403|NCT01125930|183329575|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-3 at Week 24 visit were made using fold change data.||||0.02
91718404|NCT01125930|183329575|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-9 at Week 24 visit were made using fold change data.||||0.61
91718405|NCT01125930|183329576|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||1.00
91718406|NCT01125930|183329576|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.44
91718407|NCT01125930|183329576|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.41
91718408|NCT01125930|183329576|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.94
91718409|NCT01125930|183329577|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
91718410|NCT01125930|183329578|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.13
91718411|NCT01125930|183329579|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
91527601|NCT01976364|182930475|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-0.6|
91681353|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.84|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.84|-1.00|
91681354|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.27|1.3|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.30|-1.27|
91681355|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.84|1.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.02|-1.84|
91681356|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.08|-1.04|
91681357|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.76|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.76|
91681358|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.83|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.83|
91681359|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.47|2.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.09|-0.47|
91681360|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.48|2.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.00|-0.48|
91681361|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.59|1.49|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.49|-1.59|
91681362|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.09|-1.04|
91681363|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.05|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.04|-1.05|
91681364|NCT00444457|183253334|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.09|1.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.07|-1.09|
91681365|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.4|||||TWO_SIDED|95.0|-6.52|3.63|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||3.63|-6.52|
91681366|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.7|||||TWO_SIDED|95.0|-11.3|-2.15|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-2.15|-11.30|
91681367|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.2|||||TWO_SIDED|95.0|-9.85|-0.79|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-0.79|-9.85|
91681368|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.19|2.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||2.07|-1.19|
91681369|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.69|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.69|
91681370|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.27|0.75|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||0.75|-2.27|
91681371|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.8|||||TWO_SIDED|95.0|-9.46|1.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.82|-9.46|
91681372|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.7|||||TWO_SIDED|95.0|-10.24|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||0.76|-10.24|
91681373|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-6.3|4.41|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||4.41|-6.30|
91681374|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.2|||||TWO_SIDED|95.0|-2.14|1.73|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.73|-2.14|
91681375|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.69|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.39|-1.69|
91681376|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-1.46|2.59|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.59|-1.46|
91681377|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.5|||||TWO_SIDED|95.0|-11.17|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.20|-11.17|
91681378|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-10.0|||||TWO_SIDED|95.0|-15.31|-4.7|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||-4.70|-15.31|
91681379|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.5|||||TWO_SIDED|95.0|-9.55|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.46|-9.55|
91681380|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-4.23|2.52|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||2.52|-4.23|
91681381|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.3|||||TWO_SIDED|95.0|-6.35|-0.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||-0.40|-6.35|
91681382|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.44|0.33|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.33|-5.44|
91681383|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.67|4.8|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||4.80|-3.67|
91681384|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-2.38|6.28|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||6.28|-2.38|
91681385|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.4|||||TWO_SIDED|95.0|-3.06|5.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||5.82|-3.06|
91681386|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-3.34|5.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||5.08|-3.34|
91681387|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.39|1.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.18|-6.39|
91527602|NCT01976364|182930477|OTHER||Difference in percentage of participants|11.67|||||TWO_SIDED|95.0|-15.65|38.98||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||38.98|-15.65|
91681388|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.4|||||TWO_SIDED|95.0|-7.45|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||0.46|-7.45|
91681389|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.6|||||TWO_SIDED|95.0|-5.2|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-5.20|
91681390|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.8|||||TWO_SIDED|95.0|-11.79|2.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||2.16|-11.79|
91681391|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.5|||||TWO_SIDED|95.0|-13.51|0.54|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.54|-13.51|
91681392|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|3.1|||||TWO_SIDED|95.0|-0.84|7.13|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||7.13|-0.84|
91718412|NCT01125930|183329580|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.75
91718413|NCT01125930|183329581|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.68
91718414|NCT01125930|183329582|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.77
91718415|NCT01125930|183329583|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.41
91718416|NCT01125930|183329583|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||1.00
91718417|NCT01125930|183329583|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.96
91718418|NCT01125930|183329583|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.91
91718419|NCT01125930|183329584|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
91718420|NCT01125930|183329584|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
91718421|NCT01125930|183329584|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
91718422|NCT01125930|183329584|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
91718423|NCT01125930|183329585|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.54
91526849|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.52||||0.044|TWO_SIDED|95.0|0.01|1.03||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.03|0.01|0.044
91718424|NCT01125930|183329585|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.06
91718425|NCT01125930|183329585|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.02
91718426|NCT01125930|183329585|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.09
91718427|NCT01125930|183329586|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.18
91718428|NCT01125930|183329586|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
91718429|NCT01125930|183329586|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
91718430|NCT01125930|183329586|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.35
91718431|NCT01125930|183329587|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.80
91718432|NCT01125930|183329587|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.31
91718433|NCT01125930|183329587|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.25
91718434|NCT01125930|183329587|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.46
91718435|NCT01125930|183329588|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.41
91718436|NCT01125930|183329588|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.05
91718437|NCT01125930|183329588|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.16
91718438|NCT01125930|183329588|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.14
91718439|NCT01125930|183329589|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.36
91718440|NCT01125930|183329589|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.88
91718441|NCT01125930|183329589|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.18
91718442|NCT01125930|183329589|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.17
91527603|NCT01976364|182930477|OTHER||Difference in percentage of participants|30.42|||||TWO_SIDED|95.0|0.64|60.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||60.20|0.64|
91681393|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.14|4.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||4.11|-3.14|
91681394|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.72|1.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.40|-6.72|
91681395|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.87|3.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||3.02|-0.87|
91681396|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.62|1.71|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.71|-1.62|
91681397|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-3.0|0.92|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||0.92|-3.00|
91681398|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-0.62|4.67|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||4.67|-0.62|
91681399|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.67|1.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.55|-2.67|
91681400|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.11|-0.01|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||-0.01|-5.11|
91681401|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.45|2.1|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||2.10|-0.45|
91681402|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.75|1.58|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.58|-0.75|
91681403|NCT00444457|183253336|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.86|1.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.05|-1.86|
91681404|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.13|-0.10|
91681405|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.29|||||TWO_SIDED|95.0|-0.41|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.41|
91681406|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.31|||||TWO_SIDED|95.0|-0.43|-0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.19|-0.43|
91681407|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.30|0.06|
91681408|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.0|0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.23|-0.00|
91681409|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.18|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.06|-0.18|
91681410|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
91681411|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.15|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.07|-0.15|
91681412|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
91681413|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.19|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.06|-0.19|
91526850|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.43||||0.099|TWO_SIDED|95.0|-0.08|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.08|0.099
91718443|NCT01125930|183329590|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.21
91718444|NCT01125930|183329590|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||<0.01
91718445|NCT01125930|183329590|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.04
91681414|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.17|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.17|
91681415|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.11|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.15|-0.11|
91681416|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.00|-0.25|
91681417|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.24|||||TWO_SIDED|95.0|-0.37|-0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.12|-0.37|
91681418|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.01|-0.25|
91681419|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.18|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||0.11|-0.18|
91681420|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.37|||||TWO_SIDED|95.0|-0.51|-0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.22|-0.51|
91718446|NCT01125930|183329590|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.10
91718447|NCT01125930|183329591|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||1.00
91681421|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.33|||||TWO_SIDED|95.0|-0.47|-0.2|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.20|-0.47|
91681422|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.17|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.17|
91681423|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.22|-0.07|
91681424|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.25|-0.03|
91681425|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.2|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.20|
91681426|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.21|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.03|-0.21|
91718448|NCT01125930|183329591|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.02
91681427|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.15|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.11|-0.15|
91681428|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.06|0.18|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.18|-0.06|
91681429|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.18|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.04|-0.18|
91681430|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.25|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.01|-0.25|
91681431|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.17|||||TWO_SIDED|95.0|0.05|0.28|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.28|0.05|
91681432|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|0.0|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.21|-0.00|
91681433|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.17|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.05|-0.17|
91681434|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.19|-0.04|
91681435|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|-0.02|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.21|-0.02|
91681436|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.14|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.14|-0.10|
91681437|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.03|||||TWO_SIDED|95.0|-0.1|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.15|-0.10|
91681438|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.07|-0.17|
91681439|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.2|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.05|-0.20|
91681440|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.11|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.13|-0.11|
91681441|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.14|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.10|-0.14|
91681442|NCT00444457|183253337|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.08|-0.15|
91681443|NCT03970837|183253371|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.87|3.53|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.53|1.87|<0.0001
91681444|NCT03970837|183253371|SUPERIORITY||Odds Ratio (OR)|2.55|||<|0.0001|TWO_SIDED|95.0|1.85|3.5|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.50|1.85|<0.0001
91526851|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.647|TWO_SIDED|95.0|-0.32|0.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.51|-0.32|0.647
91681445|NCT03970837|183253371|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.66|7.9|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||7.90|3.66|<0.0001
91681446|NCT03970837|183253371|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90 mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
91681447|NCT03970837|183253371|SUPERIORITY||Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
91681448|NCT03970837|183253375|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-14.7|||||TWO_SIDED|95.0|-21.3|-8.1|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-8.1|-21.3|
91681449|NCT03970837|183253375|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-17.2|||||TWO_SIDED|95.0|-23.9|-10.6|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-10.6|-23.9|
91681450|NCT02304991|183253580|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.002
91681451|NCT02304991|183253581|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.0005
91681452|NCT02304991|183253582|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91681453|NCT02304991|183253583|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||0.01
91681454|NCT02304991|183253584|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||<0.0001
91681455|NCT02304991|183253585|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
91681456|NCT00786994|183253586|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Mantel Haenszel|||A vs C/D||||0.60
91681457|NCT00786994|183253586|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Mantel Haenszel|||B vs. C/D||||0.83
91681458|NCT01193127|183253589|SUPERIORITY_OR_OTHER||least-squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.6|1.1||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates|repeated measures model|All data time points collected used in the analysis.|OMS302 - Vehicle (BSS)|||1.1|0.6|0.0000
91681459|NCT01193127|183253589|SUPERIORITY_OR_OTHER||least-squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.5|0.9||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.|repeated measures model|OMS302 - ketorolac tromethamine||||0.9|0.5|0.0000
91681460|NCT01193127|183253590|SUPERIORITY_OR_OTHER||least-squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.2||0.0421||95.0|-8.9|-0.2||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates|repeated measures model||OMS302 - Vehicle (BSS)|||-0.2|-8.9|0.0421
91681461|NCT01193127|183253590|SUPERIORITY_OR_OTHER||least-squares mean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.2||0.0093||95.0|-10.3|-1.5||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.|repeated measures model||OMS302 - PE|||-1.5|-10.3|0.0093
91681462|NCT01193127|183253591|SUPERIORITY_OR_OTHER|||||||0.63||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.630
91681463|NCT01193127|183253591|SUPERIORITY_OR_OTHER|||||||0.769||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.769
91681464|NCT01193127|183253591|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.025
91681465|NCT01193127|183253592|SUPERIORITY_OR_OTHER|||||||0.229||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.229
91681466|NCT01193127|183253592|SUPERIORITY_OR_OTHER|||||||0.162||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.162
91681467|NCT01193127|183253592|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
91681468|NCT01193127|183253593|SUPERIORITY_OR_OTHER|||||||0.177||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.177
91681469|NCT01193127|183253593|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.051
91681470|NCT01193127|183253593|SUPERIORITY_OR_OTHER|||||||0.497||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.497
91681471|NCT01193127|183253594|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
91681472|NCT01193127|183253594|SUPERIORITY_OR_OTHER|||||||0.09||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.090
91681473|NCT01193127|183253594|SUPERIORITY_OR_OTHER|||||||0.439||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.439
91681474|NCT01193127|183253595|SUPERIORITY_OR_OTHER|||||||0.812||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.812
91681475|NCT01193127|183253595|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
91681476|NCT01193127|183253595|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
91681477|NCT01193127|183253596|SUPERIORITY_OR_OTHER|||||||0.085||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.085
91681478|NCT01193127|183253596|SUPERIORITY_OR_OTHER|||||||0.742||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.742
91681479|NCT01193127|183253596|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.021
91681480|NCT01193127|183253597|SUPERIORITY_OR_OTHER|||||||0.081||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.081
91681481|NCT01193127|183253597|SUPERIORITY_OR_OTHER|||||||0.202||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.202
91681482|NCT01193127|183253597|SUPERIORITY_OR_OTHER|||||||0.606||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.606
91681483|NCT01193127|183253598|SUPERIORITY_OR_OTHER|||||||0.893||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.893
91681484|NCT01193127|183253598|SUPERIORITY_OR_OTHER|||||||0.553||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.553
91681485|NCT01193127|183253598|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.412
91681486|NCT01193127|183253599|SUPERIORITY_OR_OTHER|||||||0.186||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.186
91681487|NCT01193127|183253599|SUPERIORITY_OR_OTHER|||||||0.191||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.191
91681488|NCT01193127|183253599|SUPERIORITY_OR_OTHER|||||||0.167||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.167
91681489|NCT01193127|183253600|SUPERIORITY_OR_OTHER|||||||0.663||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.663
91681490|NCT01193127|183253600|SUPERIORITY_OR_OTHER|||||||0.326||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.326
91681491|NCT01193127|183253600|SUPERIORITY_OR_OTHER|||||||0.045||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.045
91681492|NCT01193127|183253601|SUPERIORITY_OR_OTHER|||||||0.106||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.106
91681493|NCT01193127|183253601|SUPERIORITY_OR_OTHER|||||||0.519||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.519
91681494|NCT01193127|183253601|SUPERIORITY_OR_OTHER|||||||0.039||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.039
91681495|NCT01193127|183253602|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.100
91681496|NCT01193127|183253602|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.029
91681497|NCT01193127|183253602|SUPERIORITY_OR_OTHER|||||||0.525||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.525
91681498|NCT01193127|183253603|SUPERIORITY_OR_OTHER|||||||0.642||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.642
91681499|NCT01193127|183253603|SUPERIORITY_OR_OTHER|||||||0.442||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.442
91681500|NCT01193127|183253603|SUPERIORITY_OR_OTHER|||||||0.467||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.467
91681501|NCT01193127|183253604|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.695
91681502|NCT01193127|183253604|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
91681503|NCT01193127|183253604|SUPERIORITY_OR_OTHER|||||||0.369||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.369
91681504|NCT01193127|183253605|SUPERIORITY_OR_OTHER|||||||0.124||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.124
91681505|NCT01193127|183253605|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
91681506|NCT01193127|183253605|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
91681507|NCT01193127|183253606|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.825
91681508|NCT01193127|183253606|SUPERIORITY_OR_OTHER|||||||0.211||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.211
91527604|NCT01976364|182930477|OTHER||Difference in percentage of participants|29.58|||||TWO_SIDED|95.0|-3.46|62.62||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||62.62|-3.46|
91681509|NCT01193127|183253606|SUPERIORITY_OR_OTHER|||||||0.589||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.589
91681510|NCT01193127|183253607|SUPERIORITY_OR_OTHER|||||||0.401||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.401
91681511|NCT01193127|183253607|SUPERIORITY_OR_OTHER|||||||0.2||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Chi-squared, Corrected|||||||0.200
91681512|NCT01193127|183253607|SUPERIORITY_OR_OTHER|||||||0.478||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.478
91681513|NCT01193127|183253608|SUPERIORITY_OR_OTHER|||||||0.758||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.758
91681514|NCT01193127|183253608|SUPERIORITY_OR_OTHER|||||||0.521||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.521
91681515|NCT01193127|183253608|SUPERIORITY_OR_OTHER|||||||0.432||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.432
91681516|NCT01193127|183253609|SUPERIORITY_OR_OTHER|||||||0.148||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.148
91681517|NCT01193127|183253609|SUPERIORITY_OR_OTHER|||||||0.156||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.156
91681518|NCT01193127|183253609|SUPERIORITY_OR_OTHER|||||||0.381||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.381
91681519|NCT01193127|183253610|SUPERIORITY_OR_OTHER|||||||0.646||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.646
91681520|NCT01193127|183253610|SUPERIORITY_OR_OTHER|||||||0.95||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.950
91681521|NCT01193127|183253610|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
91681522|NCT01193127|183253611|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
91681523|NCT01193127|183253611|SUPERIORITY_OR_OTHER|||||||0.667||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.667
91681524|NCT01193127|183253611|SUPERIORITY_OR_OTHER|||||||0.303||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.303
91681525|NCT01193127|183253612|SUPERIORITY_OR_OTHER|||||||0.789||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.789
91681526|NCT01193127|183253612|SUPERIORITY_OR_OTHER|||||||0.977||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.977
91681527|NCT01193127|183253612|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
91681528|NCT01193127|183253613|SUPERIORITY_OR_OTHER|||||||0.632||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.632
91681529|NCT01193127|183253613|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
91681530|NCT01193127|183253613|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
91718449|NCT01125930|183329591|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.08
91718450|NCT01125930|183329591|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.15
91718451|NCT01125930|183329592|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.67
91681531|NCT01193127|183253614|SUPERIORITY_OR_OTHER|||||||0.528||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.528
91681532|NCT01193127|183253614|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
91681533|NCT01193127|183253614|SUPERIORITY_OR_OTHER|||||||0.353||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.353
91681534|NCT01193127|183253615|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.463
91681535|NCT01193127|183253615|SUPERIORITY_OR_OTHER|||||||0.406||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.406
91681536|NCT01193127|183253615|SUPERIORITY_OR_OTHER|||||||0.245||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.245
91681537|NCT01193127|183253616|SUPERIORITY_OR_OTHER|||||||0.945||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.945
91681538|NCT01193127|183253616|SUPERIORITY_OR_OTHER|||||||0.438||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.438
91681539|NCT01193127|183253616|SUPERIORITY_OR_OTHER|||||||0.596||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.596
91681540|NCT01193127|183253617|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.811
91527605|NCT01976364|182930477|OTHER||Difference in percentage of participants|24.17|||||TWO_SIDED|95.0|-5.14|53.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||53.47|-5.14|
91681541|NCT01193127|183253617|SUPERIORITY_OR_OTHER|||||||0.552||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.552
91681542|NCT01193127|183253617|SUPERIORITY_OR_OTHER|||||||0.549||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.549
91681543|NCT01193127|183253618|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.173
91527606|NCT01976364|182930477|OTHER||Difference in percentage of participants|17.08|||||TWO_SIDED|95.0|-15.96|50.12||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||50.12|-15.96|
91681544|NCT01193127|183253618|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
91681545|NCT01193127|183253618|SUPERIORITY_OR_OTHER|||||||0.559|||||||Cochran-Mantel-Haenszel|||||||0.559
91681546|NCT01193127|183253619|SUPERIORITY_OR_OTHER|||||||0.681||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.681
91681547|NCT01193127|183253619|SUPERIORITY_OR_OTHER|||||||0.429||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.429
91681548|NCT01193127|183253619|SUPERIORITY_OR_OTHER|||||||0.306||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.306
91681549|NCT01193127|183253620|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
91681550|NCT01193127|183253620|SUPERIORITY_OR_OTHER|||||||0.602||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.602
91681551|NCT01193127|183253620|SUPERIORITY_OR_OTHER|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||0.290
91681552|NCT01193127|183253621|SUPERIORITY_OR_OTHER|||||||0.244||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.244
91681553|NCT01193127|183253621|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.122
91681554|NCT01193127|183253621|SUPERIORITY_OR_OTHER|||||||0.79||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.790
91681555|NCT01193127|183253622|SUPERIORITY_OR_OTHER|||||||0.752||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.752
91681556|NCT01193127|183253622|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
91681557|NCT01193127|183253622|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
91681558|NCT01193127|183253623|SUPERIORITY_OR_OTHER|||||||0.228||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.228
91681559|NCT01193127|183253623|SUPERIORITY_OR_OTHER|||||||0.564||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.564
91681560|NCT01193127|183253623|SUPERIORITY_OR_OTHER|||||||0.755||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.755
91681561|NCT01193127|183253624|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.018
91681562|NCT01193127|183253624|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
91681563|NCT01193127|183253624|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
91681564|NCT01193127|183253625|SUPERIORITY_OR_OTHER|||||||0.271||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.271
91681565|NCT01193127|183253625|SUPERIORITY_OR_OTHER|||||||0.345||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.345
91681566|NCT01193127|183253625|SUPERIORITY_OR_OTHER|||||||0.096||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.096
91681567|NCT01193127|183253626|SUPERIORITY_OR_OTHER|||||||0.32||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.320
91681568|NCT01193127|183253626|SUPERIORITY_OR_OTHER|||||||0.39||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.390
91681569|NCT01193127|183253626|SUPERIORITY_OR_OTHER|||||||0.23||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.230
91681570|NCT01193127|183253627|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
91681571|NCT01193127|183253627|SUPERIORITY_OR_OTHER|||||||0.348||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.348
91681572|NCT01193127|183253627|SUPERIORITY_OR_OTHER|||||||0.477||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.477
91681573|NCT01193127|183253628|SUPERIORITY_OR_OTHER|||||||0.374||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.374
91681574|NCT01193127|183253628|SUPERIORITY_OR_OTHER|||||||0.265||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.265
91681575|NCT01193127|183253628|SUPERIORITY_OR_OTHER|||||||0.555||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.555
91681576|NCT01193127|183253629|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.031
91681577|NCT01193127|183253629|SUPERIORITY_OR_OTHER|||||||0.059||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.059
91681578|NCT01193127|183253629|SUPERIORITY_OR_OTHER|||||||0.472||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.472
91681579|NCT01193127|183253630|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
91681580|NCT01193127|183253630|SUPERIORITY_OR_OTHER|||||||0.169||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.169
91681581|NCT01193127|183253630|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.310
91681582|NCT01193127|183253631|SUPERIORITY_OR_OTHER|||||||0.075||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.075
91681583|NCT01193127|183253631|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.005
91681584|NCT01193127|183253631|SUPERIORITY_OR_OTHER|||||||0.078||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.078
91681585|NCT01193127|183253632|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
91681586|NCT01193127|183253632|SUPERIORITY_OR_OTHER|||||||0.357||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.357
91681587|NCT01193127|183253632|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
91681588|NCT01193127|183253633|SUPERIORITY_OR_OTHER|||||||0.172||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.172
91681589|NCT01193127|183253633|SUPERIORITY_OR_OTHER|||||||0.547||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.547
91681590|NCT01193127|183253633|SUPERIORITY_OR_OTHER|||||||0.921||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.921
91681591|NCT01193127|183253634|SUPERIORITY_OR_OTHER|||||||0.701||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.701
91681592|NCT01193127|183253634|SUPERIORITY_OR_OTHER|||||||0.089||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.089
91681593|NCT01193127|183253634|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.095
91681594|NCT01193127|183253635|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.086
91681595|NCT01193127|183253635|SUPERIORITY_OR_OTHER|||||||0.092||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.092
91681596|NCT01193127|183253635|SUPERIORITY_OR_OTHER|||||||0.12||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.120
91681597|NCT01193127|183253636|SUPERIORITY_OR_OTHER|||||||0.626||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.626
91681598|NCT01193127|183253636|SUPERIORITY_OR_OTHER|||||||0.736||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.736
91681599|NCT01193127|183253636|SUPERIORITY_OR_OTHER|||||||0.725||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.725
91681600|NCT01193127|183253637|SUPERIORITY_OR_OTHER|||||||0.22||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.220
91681601|NCT01193127|183253637|SUPERIORITY_OR_OTHER|||||||0.903||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.903
91681602|NCT01193127|183253637|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.463
91681603|NCT01193127|183253638|SUPERIORITY_OR_OTHER|||||||0.675||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.675
91718452|NCT01125930|183329592|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.18
91718453|NCT01125930|183329592|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.02
91718454|NCT01125930|183329592|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.42
91718455|NCT02741284|183329593|NON_INFERIORITY|A noninferiority margin of 30% (mean difference \<1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity|Mean Difference (Final Values)|0.1||||0.69|TWO_SIDED|95.0|-0.5|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.5|0.69
91718456|NCT02741284|183329594|NON_INFERIORITY|Noninferiority margin 30%|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.03|||t-test, 2 sided|||pH||0.03|-0.01|<0.05
91718457|NCT02741284|183329595|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.05|TWO_SIDED|95.0|0.07|1.48|||Chi-squared|||Cesarean delivery||1.48|0.07|<0.05
91718458|NCT02741284|183329595|SUPERIORITY||Risk Ratio (RR)|0.0|||<|0.05|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Cesarean delivery for non reassuring fetal status||0|0|<0.05
91718459|NCT02741284|183329595|SUPERIORITY||Risk Ratio (RR)|5.65|||<|0.05|TWO_SIDED|95.0|0.71|45.2|||Chi-squared|||Operative vaginal delivery||45.20|0.71|<0.05
91718460|NCT02741284|183329596|SUPERIORITY||Mean Difference (Net)|-1.5||||0.44|TWO_SIDED|95.0|-5.4|2.4|||t-test, 2 sided|||||2.4|-5.4|0.44
91718461|NCT02741284|183329597|SUPERIORITY||Mean Difference (Net)|-4.7||||0.06|TWO_SIDED|95.0|-9.6|0.1|||t-test, 2 sided|||||0.1|-9.6|0.06
91718462|NCT02741284|183329598|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1.0|-1.0|0.99
91718463|NCT01516216|183329659|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
91718464|NCT01516216|183329660|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
91718465|NCT01516216|183329661|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
91718466|NCT01516216|183329663|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
91681604|NCT01193127|183253638|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|WIlcoxon rank-sum test|||||||0.825
91718467|NCT01516216|183329666|SUPERIORITY|||||||0.9801|||||||Chi-squared|||||||0.9801
91718468|NCT01516216|183329667|SUPERIORITY|||||||0.7444|||||||Chi-squared|||||||0.7444
91718469|NCT03098979|183329668|SUPERIORITY|||||||0.5183||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques.||||||0.5183
91681605|NCT01193127|183253638|SUPERIORITY_OR_OTHER|||||||0.668||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.668
91718470|NCT03098979|183329668|SUPERIORITY|||||||0.33||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.3300
91718471|NCT03098979|183329668|SUPERIORITY|||||||0.6232||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.6232
91718472|NCT03098979|183329668|SUPERIORITY|||||||0.0918||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.0918
91718473|NCT03098979|183329668|SUPERIORITY|||||||0.2701||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.2701
91718474|NCT02419807|183329689|EQUIVALENCE|Equivalence is defined as the difference in the proportions of nodes flagged between the Tc and ICG methods falling within an interval (-δ, +δ), where δ is taken to be 5%.|Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|0.036|0.151||||||||0.151|0.036|
91718475|NCT01499511|183329698|SUPERIORITY|||||||0.624|||||||ANOVA|||||||0.624
91718476|NCT01499511|183329699|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
91718477|NCT01499511|183329700|SUPERIORITY|||||||0.304|||||||ANOVA|||||||0.304
91718478|NCT01499511|183329701|SUPERIORITY|||||||0.641|||||||ANOVA|||||||0.641
91718479|NCT01499511|183329702|SUPERIORITY|||||||0.915|||||||ANOVA|||||||0.915
91718480|NCT04459338|183329727|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||All continuous data are summarized as means ± SEM. Area Under the Curve (AUC) was calculated using the trapezoidal rule. A paired, two-way Student t-test (parametric) or a Wilcoxon matched-pairs signed rank test (non-parametric) was used to examine differences between study days. A p-value \<0.05 was considered statistically significant.||||0.02
91718481|NCT00853385|183329740|SUPERIORITY_OR_OTHER||Percent difference|24.24|||<|0.0001|TWO_SIDED|95.0|13.18|35.31||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||35.31|13.18|<0.0001
91718482|NCT00853385|183329740|SUPERIORITY_OR_OTHER||Percent difference|23.22|||<|0.0001|TWO_SIDED|95.0|12.16|34.29||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||34.29|12.16|<0.0001
91718483|NCT00853385|183329740|SUPERIORITY_OR_OTHER||Percent difference|18.93||||0.0007|TWO_SIDED|95.0|7.9|29.96||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||29.96|7.90|0.0007
91718484|NCT00853385|183329741|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.5|-0.25||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.25|-0.50|<0.0001
91718485|NCT00853385|183329741|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.19||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.19|-0.43|<0.0001
91718486|NCT00853385|183329741|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.13||Statistical testing was done at 5% significance level (2-sided).|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.13|-0.37|<0.0001
91718487|NCT00853385|183329742|SUPERIORITY_OR_OTHER||Percent difference|11.41|||<|0.0001|TWO_SIDED|95.0|6.08|16.73||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||16.73|6.08|<0.0001
91718488|NCT00853385|183329742|SUPERIORITY_OR_OTHER||Percent difference|5.12||||0.0151|TWO_SIDED|95.0|0.98|9.26||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.26|0.98|0.0151
91718489|NCT00853385|183329742|SUPERIORITY_OR_OTHER||Percent difference|5.65||||0.0091|TWO_SIDED|95.0|1.4|9.9||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.90|1.40|0.0091
91718490|NCT01829347|183329837|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.076|TWO_SIDED|95.0|0.085|1.133|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-Treat (ITT) population utilizing a log-rank test.||1.133|0.085|0.076
91718491|NCT01829347|183329838|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91718492|NCT03435055|183329839|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that the results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.001
91718493|NCT03435055|183329840|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.006
91681606|NCT01193127|183253639|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
91681607|NCT01193127|183253639|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
91681608|NCT01193127|183253639|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5263
91681609|NCT01193127|183253640|SUPERIORITY_OR_OTHER|||||||0.4222||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4222
91681610|NCT01193127|183253640|SUPERIORITY_OR_OTHER|||||||0.2712||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2712
91681611|NCT01193127|183253640|SUPERIORITY_OR_OTHER|||||||0.8819||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8819
91681612|NCT01193127|183253641|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0510
91681613|NCT01193127|183253641|SUPERIORITY_OR_OTHER|||||||0.8084||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8084
91681614|NCT01193127|183253641|SUPERIORITY_OR_OTHER|||||||0.1495||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1495
91681615|NCT01193127|183253642|SUPERIORITY_OR_OTHER|||||||0.4099||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4099
91681616|NCT01193127|183253642|SUPERIORITY_OR_OTHER|||||||0.6499||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6499
91681617|NCT01193127|183253642|SUPERIORITY_OR_OTHER|||||||0.0765||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0765
91681618|NCT01193127|183253643|SUPERIORITY_OR_OTHER|||||||0.0688||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0688
91718494|NCT03435055|183329841|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Paired-t tests were conducted to determine whether changes in stimulus intensity: post stimulus at baseline and under subanesthetic dose of nitrous oxide. Statistical tests were completed in SPSS 26 and determined by p \< 0.05.||||<0.01
91527607|NCT01976364|182930478|OTHER||Difference in percentage of participants|4.99|||||TWO_SIDED|95.0|-9.61|19.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||19.60|-9.61|
91681619|NCT01193127|183253643|SUPERIORITY_OR_OTHER|||||||0.0314||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0314
91681620|NCT01193127|183253643|SUPERIORITY_OR_OTHER|||||||0.0775||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0775
91681621|NCT01193127|183253644|SUPERIORITY_OR_OTHER|||||||0.5369||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5369
91681622|NCT01193127|183253644|SUPERIORITY_OR_OTHER|||||||0.3763||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.3763
91681623|NCT01193127|183253644|SUPERIORITY_OR_OTHER|||||||0.6144||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6144
91681624|NCT01193127|183253645|SUPERIORITY_OR_OTHER|||||||0.1374||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1374
91681625|NCT01193127|183253645|SUPERIORITY_OR_OTHER|||||||0.9146||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.9146
91681626|NCT01193127|183253645|SUPERIORITY_OR_OTHER|||||||0.7599||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.7599
91681627|NCT01193127|183253646|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
91681628|NCT01193127|183253646|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
91681629|NCT01193127|183253646|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
91681630|NCT01193127|183253647|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
91681631|NCT01193127|183253647|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.647
91718495|NCT03435055|183329842|OTHER|Paired T-test comparing baseline to nitrous||||||0.0622|||||||Paired t-test|||Delta||||0.0622
91718496|NCT03435055|183329842|OTHER|Paired T-test comparing baseline to nitrous||||||0.0292|||||||Paired t-test|||Theta||||0.0292
91718497|NCT03435055|183329842|OTHER|Paired T-test comparing baseline to nitrous||||||0.5905|||||||Paired t-test|||Alpha comparison||||0.5905
91681632|NCT01193127|183253647|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
91681633|NCT01193127|183253648|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
91681634|NCT01193127|183253648|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.335
91681635|NCT01193127|183253648|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
91681636|NCT01193127|183253649|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
91681637|NCT01193127|183253649|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
91681638|NCT01193127|183253649|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
91681639|NCT01193127|183253650|SUPERIORITY_OR_OTHER|||||||0.824||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.824
91681640|NCT01193127|183253650|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
91681641|NCT01193127|183253650|SUPERIORITY_OR_OTHER|||||||0.281||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.281
91681642|NCT01193127|183253651|SUPERIORITY_OR_OTHER|||||||0.842||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.842
91681643|NCT01193127|183253651|SUPERIORITY_OR_OTHER|||||||0.619||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.619
91681644|NCT01193127|183253651|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
91681645|NCT01193127|183253652|SUPERIORITY_OR_OTHER|||||||0.773||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.773
91681646|NCT01193127|183253652|SUPERIORITY_OR_OTHER|||||||0.592||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.592
91681647|NCT01193127|183253652|SUPERIORITY_OR_OTHER|||||||0.787||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.787
91681648|NCT01193127|183253653|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
91681649|NCT01193127|183253653|SUPERIORITY_OR_OTHER|||||||0.166||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.166
91681650|NCT01193127|183253653|SUPERIORITY_OR_OTHER|||||||0.987||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.987
91681651|NCT01193127|183253654|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.134
91681652|NCT01193127|183253654|SUPERIORITY_OR_OTHER|||||||0.71||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.710
91681653|NCT01193127|183253654|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.310
91681654|NCT01193127|183253655|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.086
91681655|NCT01193127|183253655|SUPERIORITY_OR_OTHER|||||||0.183||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.183
91681656|NCT01193127|183253655|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.029
91681657|NCT01193127|183253656|SUPERIORITY_OR_OTHER|||||||0.206||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.206
91681658|NCT01193127|183253656|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.021
91718498|NCT01668797|183329859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.||The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 1:1 (brexpiprazole:placebo) randomization ratio.||||<0.0001
91718499|NCT01668797|183329860|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||The percentage of participants with impending relapse in treatment groups (Brexpiprazole and placebo) in final analysis for participants meeting at least one of the criteria.||||<0.0001
91718500|NCT01668797|183329861|SUPERIORITY_OR_OTHER|||||||0.2296|||||||Chi-squared|||Statistical analysis at Week 6.||||0.2296
91718501|NCT01668797|183329861|SUPERIORITY_OR_OTHER|||||||0.2051|||||||Chi-squared|||Statistical analysis at Week 12.||||0.2051
91718502|NCT01668797|183329861|SUPERIORITY_OR_OTHER|||||||0.7354|||||||Chi-squared|||Statistical analysis at Week 24.||||0.7354
91718503|NCT01668797|183329861|SUPERIORITY_OR_OTHER|||||||0.1977|||||||Chi-squared|||Statistical analysis at Week 36.||||0.1977
91718504|NCT01668797|183329861|SUPERIORITY_OR_OTHER|||||||0.8734|||||||Chi-squared|||Statistical analysis at Week 52.||||0.8734
91718505|NCT01668797|183329861|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||Statistical analysis at Last Visit.||||0.0007
91718506|NCT01668797|183329862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.0664|TWO_SIDED|95.0|-6.82|0.23|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 6.||0.23|-6.82|0.0664
91718507|NCT01668797|183329862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31||||0.0301|TWO_SIDED|95.0|-10.1|-0.52|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 12.||-0.52|-10.1|0.0301
91718508|NCT01668797|183329862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.77||||0.0226|TWO_SIDED|95.0|-8.86|-0.68|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 24.||-0.68|-8.86|0.0226
91718509|NCT01668797|183329862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.0086|TWO_SIDED|95.0|-10.5|-1.59|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 36.||-1.59|-10.5|0.0086
91718510|NCT01668797|183329862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.31||||0.28|TWO_SIDED|95.0|-18.1|5.46|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 52.||5.46|-18.1|0.2800
91718511|NCT01668797|183329862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42||||0.0011|TWO_SIDED|95.0|-7.01|-1.82|||Mixed Models Analysis|||Statistical analysis at across visits||-1.82|-7.01|0.0011
91718512|NCT01668797|183329863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0683|TWO_SIDED|95.0|-6.31|0.23|||ANCOVA|||Statistical analysis at Week 6.||0.23|-6.31|0.0683
91718513|NCT01668797|183329863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.05||||0.0174|TWO_SIDED|95.0|-9.2|-0.9|||ANCOVA|||Statistical analysis at Week 12.||-0.90|-9.20|0.0174
91718514|NCT01668797|183329863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59||||0.0008|TWO_SIDED|95.0|-12.0|-3.18|||ANCOVA|||Statistical analysis at Week 24.||-3.18|-12.0|0.0008
91718515|NCT01668797|183329863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.0005|TWO_SIDED|95.0|-12.4|-3.59|||ANCOVA|||Statistical analysis at Week 36.||-3.59|-12.4|0.0005
91718516|NCT01668797|183329863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.95||||0.0007|TWO_SIDED|95.0|-12.5|-3.41|||ANCOVA|||Statistical analysis at Week 52.||-3.41|-12.5|0.0007
91718517|NCT01668797|183329864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.0507|TWO_SIDED|95.0|-2.23|0.0|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.00|-2.23|0.0507
91718518|NCT01668797|183329864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.008|TWO_SIDED|95.0|-3.24|-0.5|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.50|-3.24|0.0080
91718519|NCT01668797|183329864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0215|TWO_SIDED|95.0|-2.89|-0.24|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.24|-2.89|0.0215
91718520|NCT01668797|183329864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.0053|TWO_SIDED|95.0|-3.19|-0.58|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.58|-3.19|0.0053
91718521|NCT01668797|183329864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.339|TWO_SIDED|95.0|-5.2|-0.22|||Mixed Models Analysis|||Statistical analysis at Week 52.||-0.22|-5.20|0.339
91718522|NCT01668797|183329864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.32|-0.88|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.88|-2.32|< 0.0001
91718523|NCT01668797|183329865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.1093|TWO_SIDED|95.0|-2.1|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-2.10|0.1093
91718524|NCT01668797|183329865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0089|TWO_SIDED|95.0|-3.25|-0.47|||ANOVA|||Statistical analysis at Week 12.||-0.47|-3.25|0.0089
91718525|NCT01668797|183329865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.0005|TWO_SIDED|95.0|-4.26|-1.22|||ANCOVA|||Statistical analysis at Week 24.||-1.22|-4.26|0.0005
91718526|NCT01668797|183329865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.0001|TWO_SIDED|95.0|-4.43|-1.44|||ANCOVA|||Statistical analysis at Week 36.||-1.44|-4.43|0.0001
91718527|NCT01668797|183329865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.66|||ANCOVA|||Statistical analysis at Week 52||-1.66|-4.70|<0.0001
91718528|NCT01668797|183329866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.165|TWO_SIDED|95.0|-1.66|0.29|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.29|-1.66|0.1650
91681659|NCT01193127|183253656|SUPERIORITY_OR_OTHER|||||||0.026||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.026
91681660|NCT01193127|183253657|SUPERIORITY_OR_OTHER|||||||0.822||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.822
91681661|NCT01193127|183253657|SUPERIORITY_OR_OTHER|||||||0.424||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.424
91681662|NCT01193127|183253657|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
91681663|NCT01193127|183253658|SUPERIORITY_OR_OTHER|||||||0.489||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.489
91681664|NCT01193127|183253658|SUPERIORITY_OR_OTHER|||||||0.459||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.459
91681665|NCT01193127|183253658|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.990
91681666|NCT01193127|183253660|SUPERIORITY_OR_OTHER|||||||0.4575||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.4575
91681667|NCT01193127|183253660|SUPERIORITY_OR_OTHER|||||||0.8318||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8318
91681668|NCT01193127|183253660|SUPERIORITY_OR_OTHER|||||||0.8946||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8946
91681669|NCT01193127|183253661|SUPERIORITY_OR_OTHER|||||||0.157||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.1570
91681670|NCT01193127|183253661|SUPERIORITY_OR_OTHER|||||||0.0839||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0839
91681671|NCT01193127|183253661|SUPERIORITY_OR_OTHER|||||||0.092||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0920
91681672|NCT01193127|183253662|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
91681673|NCT01193127|183253662|SUPERIORITY_OR_OTHER|||||||0.253||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.253
91681674|NCT01193127|183253662|SUPERIORITY_OR_OTHER|||||||0.104||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.104
91681675|NCT00321737|183253680|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
91681676|NCT00321737|183253680|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
91681677|NCT00321737|183253680|SUPERIORITY_OR_OTHER||||||>|0.99999||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.99999
91681678|NCT00321737|183253681|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91718529|NCT01668797|183329866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2001|TWO_SIDED|95.0|-1.97|0.42|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.42|-1.97|0.2001
91681679|NCT00321737|183253681|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91681680|NCT00321737|183253681|SUPERIORITY_OR_OTHER|||||||0.0673||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.06730
91681681|NCT00321737|183253683|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
91681682|NCT00321737|183253683|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
91681683|NCT00321737|183253683|SUPERIORITY_OR_OTHER|||||||0.13932||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.13932
91681684|NCT00321737|183253684|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91681685|NCT00321737|183253684|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
91681686|NCT00321737|183253684|SUPERIORITY_OR_OTHER|||||||0.11257||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.11257
91681687|NCT04994483|183253708|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4308|TWO_SIDED|95.0|-1.37|0.59|||Mixed Models Analysis|||||0.59|-1.37|0.4308
91681688|NCT04994483|183253709|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.4034|TWO_SIDED|95.0|-0.68|1.7|||Mixed Models Analysis|||||1.70|-0.68|0.4034
91681689|NCT00759902|183253717|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|123.0||||||90.0|112.9|134.1|||ANOVA|log-transformation||||134.1|112.9|
91681690|NCT00759902|183253719|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|98.5|104.9|||ANOVA|log-transformation||||104.9|98.5|
91681691|NCT00759902|183253720|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|102.9||||||90.0|99.3|106.5|||ANOVA|log-transformation||||106.5|99.3|
91681692|NCT02213510|183253721|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91681693|NCT02213510|183253722|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||t-test, 2 sided|||||||0.655
91681694|NCT02213510|183253723|SUPERIORITY_OR_OTHER|||||||0.811|TWO_SIDED||||||t-test, 2 sided|||||||0.811
91718530|NCT01668797|183329866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.0939|TWO_SIDED|95.0|-2.07|0.16|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.16|-2.07|0.0939
91681695|NCT02213510|183253724|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
91681696|NCT02213510|183253725|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||t-test, 2 sided|||||||0.462
91681697|NCT02213510|183253726|SUPERIORITY_OR_OTHER|||||||0.646|TWO_SIDED||||||t-test, 2 sided|||||||0.646
91681698|NCT02213510|183253727|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.510
91681699|NCT02213510|183253728|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||t-test, 2 sided|||||||0.651
91681700|NCT02213510|183253729|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.588
91681701|NCT02213510|183253730|SUPERIORITY_OR_OTHER|||||||0.858|TWO_SIDED||||||t-test, 2 sided|||||||0.858
91681702|NCT02213510|183253731|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
91681703|NCT03954834|183253732|SUPERIORITY||LS Mean Difference|-1.91|||<|0.001|TWO_SIDED|95.0|-2.18|-1.63|||Mixed Models Analysis|||||-1.63|-2.18|<0.001
91681704|NCT03954834|183253732|SUPERIORITY||LS Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.21|-1.65|||Mixed Models Analysis|||||-1.65|-2.21|<0.001
91681705|NCT03954834|183253732|SUPERIORITY||LS Mean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||Mixed Models Analysis|||||-1.83|-2.39|<0.001
91681706|NCT03954834|183253733|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-7.8|-4.7|||Mixed Models Analysis|||||-4.7|-7.8|<0.001
91681707|NCT03954834|183253733|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.6|-5.5|||Mixed Models Analysis|||||-5.5|-8.6|<0.001
91681708|NCT03954834|183253733|SUPERIORITY||LS Mean Difference|-8.8|||<|0.001|TWO_SIDED|95.0|-10.3|-7.2|||Mixed Models Analysis|||||-7.2|-10.3|<0.001
91681709|NCT03954834|183253734|SUPERIORITY||Odds Ratio (OR)|49.0|||<|0.001|TWO_SIDED|95.0|21.12|113.67|||Regression, Logistic|||||113.67|21.12|<0.001
91681710|NCT03954834|183253734|SUPERIORITY||Odds Ratio (OR)|80.39|||<|0.001|TWO_SIDED|95.0|31.8|203.19|||Regression, Logistic|||||203.19|31.80|<0.001
91681711|NCT03954834|183253734|SUPERIORITY||Odds Ratio (OR)|52.95|||<|0.001|TWO_SIDED|95.0|22.3|125.73|||Regression, Logistic|||||125.73|22.30|<0.001
91681712|NCT03954834|183253735|SUPERIORITY||LS Mean Difference|-1.5||||0.776|TWO_SIDED|95.0|-11.9|8.9|||Mixed Models Analysis|||||8.9|-11.9|0.776
91681713|NCT03954834|183253735|SUPERIORITY||LS Mean Difference|-2.6||||0.622|TWO_SIDED|95.0|-13.0|7.8|||Mixed Models Analysis|||||7.8|-13.0|0.622
91681714|NCT03954834|183253735|SUPERIORITY||LS Mean Difference|-0.6||||0.908|TWO_SIDED|95.0|-11.1|9.8|||Mixed Models Analysis|||||9.8|-11.1|0.908
91681715|NCT03954834|183253736|SUPERIORITY||Odds Ratio (OR)|40.28|||<|0.001|TWO_SIDED|95.0|7.74|209.71|||Regression, Logistic|||||209.71|7.74|<0.001
91681716|NCT03954834|183253736|SUPERIORITY||Odds Ratio (OR)|34.12|||<|0.001|TWO_SIDED|95.0|6.53|178.19|||Regression, Logistic|||||178.19|6.53|<0.001
91681717|NCT03954834|183253736|SUPERIORITY||Odds Ratio (OR)|85.13|||<|0.001|TWO_SIDED|95.0|16.36|443.13|||Regression, Logistic|||||443.13|16.36|<0.001
91681718|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.1|-31.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-31.2|-44.1|<0.001
91681719|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-38.6|||<|0.001|TWO_SIDED|95.0|-45.1|-32.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-32.2|-45.1|<0.001
91681720|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-36.5|||<|0.001|TWO_SIDED|95.0|-43.1|-29.8|||Mixed Models Analysis|||Morning Premeal - Fasting||-29.8|-43.1|<0.001
91681721|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-57.9|||<|0.001|TWO_SIDED|95.0|-68.4|-47.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-47.4|-68.4|<0.001
91681722|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-49.7|||<|0.001|TWO_SIDED|95.0|-60.3|-39.2|||Mixed Models Analysis|||Morning 2-hour Postmeal||-39.2|-60.3|<0.001
91681723|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-57.3|||<|0.001|TWO_SIDED|95.0|-68.1|-46.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-46.4|-68.1|<0.001
91681724|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-40.9|||<|0.001|TWO_SIDED|95.0|-49.6|-32.2|||Mixed Models Analysis|||Midday Premeal||-32.2|-49.6|<0.001
91681725|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-39.9|||<|0.001|TWO_SIDED|95.0|-48.6|-31.2|||Mixed Models Analysis|||Midday Premeal||-31.2|-48.6|<0.001
91681726|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-40.0|||<|0.001|TWO_SIDED|95.0|-49.0|-31.1|||Mixed Models Analysis|||Midday Premeal||-31.1|-49.0|<0.001
91681727|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-51.4|||<|0.001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||Midday 2-hour Postmeal||-40.4|-62.5|<0.001
91681728|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-47.3|||<|0.001|TWO_SIDED|95.0|-58.4|-36.2|||Mixed Models Analysis|||Midday 2-hour Postmeal||-36.2|-58.4|<0.001
91681729|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-62.1|-39.3|||Mixed Models Analysis|||Midday 2-hour Postmeal||-39.3|-62.1|<0.001
91718531|NCT01668797|183329866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.1396|TWO_SIDED|95.0|-2.44|0.35|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.35|-2.44|0.1396
91718532|NCT01668797|183329866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.847|TWO_SIDED|95.0|-4.14|5.0|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.00|-4.14|0.8470
91718533|NCT01668797|183329866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.2258|TWO_SIDED|95.0|-1.24|0.3|||Mixed Models Analysis|||Statistical analysis at across visits.||0.3|-1.24|0.2258
91718534|NCT01668797|183329867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0981|TWO_SIDED|95.0|-1.65|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.65|0.0981
91718535|NCT01668797|183329867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0264|TWO_SIDED|95.0|-2.3|-0.15|||ANCOVA|||Statistical analysis at Week 12.||-0.15|-2.30|0.0264
91718536|NCT01668797|183329867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.0078|TWO_SIDED|95.0|-2.69|-0.42|||ANCOVA|||Statistical analysis at Week 24.||-0.42|-2.69|0.0078
91718537|NCT01668797|183329867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0101|TWO_SIDED|95.0|-2.77|-0.38|||ANCOVA|||Statistical analysis at Week 36.||-0.38|-2.77|0.0101
91718538|NCT01668797|183329867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0516|TWO_SIDED|95.0|-2.5|0.01|||ANCOVA|||Statistical analysis at Week 52||0.01|-2.50|0.0516
91718539|NCT01668797|183329868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0279|TWO_SIDED|95.0|-0.53|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.03|-0.53|0.0279
91681730|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-39.0|||<|0.001|TWO_SIDED|95.0|-47.6|-30.4|||Mixed Models Analysis|||Evening Premeal||-30.4|-47.6|<0.001
91681731|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-39.2|||<|0.001|TWO_SIDED|95.0|-47.9|-30.6|||Mixed Models Analysis|||Evening Premeal||-30.6|-47.9|<0.001
91681732|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-36.4|||<|0.001|TWO_SIDED|95.0|-45.3|-27.5|||Mixed Models Analysis|||Evening Premeal||-27.5|-45.3|<0.001
91681733|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-63.2|-40.1|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.1|-63.2|<0.001
91681734|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-52.5|||<|0.001|TWO_SIDED|95.0|-64.1|-40.9|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.9|-64.1|<0.001
91681735|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-53.2|||<|0.001|TWO_SIDED|95.0|-65.1|-41.3|||Mixed Models Analysis|||Evening 2-hour Postmeal||-41.3|-65.1|<0.001
91681736|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-48.0|||<|0.001|TWO_SIDED|95.0|-58.6|-37.4|||Mixed Models Analysis|||Bedtime||-37.4|-58.6|<0.001
91681737|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-61.3|-40.1|||Mixed Models Analysis|||Bedtime||-40.1|-61.3|<0.001
91681738|NCT03954834|183253737|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-62.6|-40.9|||Mixed Models Analysis|||||-40.9|-62.6|<0.001
91681739|NCT03954834|183253738|SUPERIORITY||Odds Ratio (OR)|12.4|||<|0.001|TWO_SIDED|95.0|6.43|23.94|||Regression, Logistic|||||23.94|6.43|<0.001
91681740|NCT03954834|183253738|SUPERIORITY||Odds Ratio (OR)|21.13|||<|0.001|TWO_SIDED|95.0|10.59|42.18|||Regression, Logistic|||||42.18|10.59|<0.001
91681741|NCT03954834|183253738|SUPERIORITY||Odds Ratio (OR)|20.1|||<|0.001|TWO_SIDED|95.0|10.09|40.04|||Regression, Logistic|||||40.04|10.09|<0.001
91681742|NCT01404923|183253748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
91681743|NCT00945100|183253757|SUPERIORITY_OR_OTHER||Risk difference (unadjusted)|22.0||||0.003|TWO_SIDED|95.0|8.0|35.0|||Regression, Logistic|The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||35|8|0.003
91681744|NCT00945100|183253758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.01|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|The ANCOVA model included interocular difference at randomization as an adjustment covariate.||||1.0|0.1|0.01
91681745|NCT00945100|183253760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.002|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||1.0|0.3|0.002
91718540|NCT01668797|183329868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0117|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.09|-0.68|0.0117
91718541|NCT01668797|183329868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0105|TWO_SIDED|95.0|-0.64|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.09|-0.64|0.0105
91718542|NCT01668797|183329868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0007|TWO_SIDED|95.0|-0.87|-0.25|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.25|-0.87|0.0007
91718543|NCT01668797|183329868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.078|TWO_SIDED|95.0|-1.09|0.06|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.06|-1.09|0.0780
91718544|NCT01668797|183329868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0006|TWO_SIDED|95.0|-0.54|-0.15|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.15|-0.54|0.0006
91718545|NCT01668797|183329869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0284|TWO_SIDED|95.0|-0.47|-0.03|||ANCOVA|||Statistical analysis at Week 6.||-0.03|-0.47|0.0284
91718546|NCT01668797|183329869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0056|TWO_SIDED|95.0|-0.62|-0.11|||ANCOVA|||Statistical analysis at Week 12.||-0.11|-0.62|0.0056
91718547|NCT01668797|183329869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0002|TWO_SIDED|95.0|-0.76|-0.24|||ANCOVA|||Statistical analysis at Week 24.||-0.24|-0.76|0.0002
91718548|NCT01668797|183329869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.3|||ANCOVA|||Statistical analysis at Week 36.||-0.30|-0.82|<.0001
91718549|NCT01668797|183329869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0002|TWO_SIDED|95.0|-0.79|-0.26|||ANCOVA|||Statistical analysis at Week 52||-0.26|-0.79|0.0002
91718550|NCT01668797|183329870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0387|TWO_SIDED|95.0|-0.6|-0.2|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 6.||-0.20|-0.60|0.0387
91718551|NCT01668797|183329870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0185|TWO_SIDED|95.0|-0.75|-0.07|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 12.||-0.07|-0.75|0.0185
91718552|NCT01668797|183329870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.97|-0.24|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 24.||-0.24|-0.97|0.0010
91718553|NCT01668797|183329870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0004|TWO_SIDED|95.0|-1.02|-0.3|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 36.||-0.30|-1.02|0.0004
91718554|NCT01668797|183329870|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 52.||-0.25|-0.96|0.0009
91718555|NCT01668797|183329871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.6525|TWO_SIDED|95.0|-3.47|5.49|||Mixed Models Analysis|||Statistical analysis at Week 24.||5.49|-3.47|0.6525
91718556|NCT01668797|183329871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08||||0.1677|TWO_SIDED|95.0|-2.71|14.87|||Mixed Models Analysis|||Statistical analysis at Week 52.||14.87|-2.71|0.1677
91718557|NCT01668797|183329871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.55||||0.2347|TWO_SIDED|95.0|-2.41|9.5|||Mixed Models Analysis|||Statistical analysis at across visits.||9.5|-2.41|0.2347
91527608|NCT01976364|182930478|OTHER||Difference in percentage of participants|3.88|||||TWO_SIDED|95.0|-10.74|18.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.50|-10.74|
91718558|NCT01668797|183329872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.0285|TWO_SIDED|95.0|0.4|7.17|||ANCOVA|||Statistical analysis at Week 24.||7.17|0.40|0.0285
91718559|NCT01668797|183329872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.0071|TWO_SIDED|95.0|1.31|8.18|||ANCOVA|||Statistical analysis at Week 52.||8.18|1.31|0.0071
91718560|NCT01668797|183329873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.329|TWO_SIDED|95.0|-1.65|4.88|||Mixed Models Analysis|||Statistical analysis at Week 12.||4.88|-1.65|0.3290
91718561|NCT01668797|183329873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||0.1765|TWO_SIDED|95.0|-1.22|6.54|||Mixed Models Analysis|||Statistical analysis at Week 24.||6.54|-1.22|0.1765
91718562|NCT01668797|183329873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5||||0.0331|TWO_SIDED|95.0|0.38|8.63|||Mixed Models Analysis|||Statistical analysis at Week 36.||8.63|0.38|0.0331
91718563|NCT01668797|183329873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88||||0.0522|TWO_SIDED|95.0|-0.06|11.82|||Mixed Models Analysis|||Statistical analysis at Week 52.||11.82|-0.06|0.0522
91718564|NCT01668797|183329873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66||||0.0281|TWO_SIDED|95.0|0.41|6.92|||Mixed Models Analysis|||Statistical analysis at across visits.||6.92|0.41|0.0281
91718565|NCT01668797|183329874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.0111|TWO_SIDED|95.0|0.9|6.86|||ANCOVA|||Statistical analysis at Week 12.||6.86|0.90|0.0111
91718566|NCT01668797|183329874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36||||0.0014|TWO_SIDED|95.0|2.1|8.62|||ANCOVA|||Statistical analysis at Week 24.||8.62|2.10|0.0014
91718567|NCT01668797|183329874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81|||<|0.0001|TWO_SIDED|95.0|3.61|10.0|||ANCOVA|||Statistical analysis at Week 36.||10.00|3.61|<.0001
91718568|NCT01668797|183329874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.55||||0.0001|TWO_SIDED|95.0|3.28|9.83|||ANCOVA|||Statistical analysis at Week 52.||9.83|3.28|0.0001
91718569|NCT01668797|183329875|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Log Rank|||||||0.0014
91718570|NCT01668797|183329876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.1577|TWO_SIDED|95.0|-1.02|0.17|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.17|-1.02|0.1577
91718571|NCT01668797|183329876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1685|TWO_SIDED|95.0|-1.61|0.28|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.28|-1.61|0.1685
91718572|NCT01668797|183329876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.2815|TWO_SIDED|95.0|-1.43|0.42|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.42|-1.43|0.2815
91718573|NCT01668797|183329876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0286|TWO_SIDED|95.0|-2.16|-0.12|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.12|-2.16|0.0286
91681746|NCT00945100|183253764|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.04
91718574|NCT01668797|183329876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.1803|TWO_SIDED|95.0|-2.58|0.51|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.51|-2.58|0.1803
91681747|NCT00945100|183253764|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.89
91681748|NCT00945100|183253764|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.49
91681749|NCT00945100|183253764|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANCOVA|||The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term.||||0.37
91681750|NCT00945100|183253764|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.50
91681751|NCT00945100|183253766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.04|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||1.0|0.04|
91681752|NCT00945100|183253774|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.||||>0.99
91681753|NCT00945100|183253776|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.||||0.12
91681754|NCT00945100|183253780|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.28
91681755|NCT00945100|183253783|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.45
91718575|NCT01668797|183329876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0077|TWO_SIDED|95.0|-1.12|-0.17|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.17|-1.12|0.0077
91681756|NCT02684630|183253789|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
91681757|NCT02684630|183253790|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
91681758|NCT00000378|183253797|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||actual calculation|Regression, Logistic|||logistic regression and mixed effects model||||<0.05
91681759|NCT01284361|183253818|SUPERIORITY_OR_OTHER||Proportion|91.5|||||TWO_SIDED|95.0|84.5|97.5|||||Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.|The sample size of 81 subjects provides a 10.8% margin of error.||97.5|84.5|
91681760|NCT00505375|183253859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.0014
91718576|NCT01668797|183329877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1852|TWO_SIDED|95.0|-1.06|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-1.06|0.1852
91718577|NCT01668797|183329877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.143|TWO_SIDED|95.0|-1.47|0.21|||ANCOVA|||Statistical analysis at Week 12.||0.21|-1.47|0.1430
91718578|NCT01668797|183329877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0323|TWO_SIDED|95.0|-2.06|-0.09|||ANCOVA|||Statistical analysis at Week 24.||-0.09|-2.06|0.0323
91681761|NCT02906930|183253860|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.3|<0.0001
91681762|NCT02906930|183253860|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.1|<0.0001
91681763|NCT02906930|183253860|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.8|<0.0001
91681764|NCT02906930|183253860|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 3 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.9|<0.0001
91681765|NCT02906930|183253860|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.5|<0.0001
91681766|NCT02906930|183253860|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
91681767|NCT02906930|183253861|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.5|-3.1|<0.0001
91718579|NCT01668797|183329877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0071|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis at Week 36.||-0.37|-2.31|0.0071
91718580|NCT01668797|183329877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.0023|TWO_SIDED|95.0|-2.52|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.52|0.0023
91681768|NCT02906930|183253861|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0866|TWO_SIDED|95.0|-1.9|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-1.9|0.0866
91681769|NCT02906930|183253861|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.8692|TWO_SIDED|95.0|-0.9|0.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.8|-0.9|0.8692
91681770|NCT02906930|183253861|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.2||||0.7075|TWO_SIDED|95.0|-1.0|0.6|||MMRM||Oral Semaglutide 3 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-1.0|0.7075
91681771|NCT02906930|183253861|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.0||||0.0138|TWO_SIDED|95.0|-1.8|-0.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.8|0.0138
91681772|NCT02906930|183253861|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.4|<0.0001
91681773|NCT02906930|183253884|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.45||||0.0043|TWO_SIDED|95.0|0.26|0.78||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.78|0.26|0.0043
91681774|NCT02906930|183253884|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.18|0.59||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.59|0.18|0.0002
91681775|NCT02906930|183253884|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.19|0.6||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.60|0.19|0.0002
91681776|NCT02906930|183253885|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.03|TWO_SIDED|95.0|0.25|0.93||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.93|0.25|0.0300
91718581|NCT01668797|183329878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0288|TWO_SIDED|95.0|-2.54|-0.14|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.14|-2.54|0.0288
91718582|NCT01668797|183329878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.0128|TWO_SIDED|95.0|-3.6|-0.44|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.44|-3.60|0.0128
91527609|NCT01976364|182930478|OTHER||Difference in percentage of participants|2.82|||||TWO_SIDED|95.0|-11.8|17.45||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.45|-11.80|
91681777|NCT02906930|183253885|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.13||||0.0001|TWO_SIDED|95.0|0.04|0.36||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.36|0.04|0.0001
91681778|NCT02906930|183253885|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.06||||0.0001|TWO_SIDED|95.0|0.01|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg /Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.01|0.0001
91681779|NCT02603393|183253938|NON_INFERIORITY|Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) -50 mL.|Mean Difference (Final Values)|-0.026||||0.0404||95.0|-0.053|0.001||1 sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0404
91681780|NCT02603393|183253939|SUPERIORITY||Ratio of rates|1.08||||0.5802||95.0|0.83|1.4||2 sided|Generalized Linear Model Analysis|||||1.40|0.83|0.5802
91681781|NCT02603393|183253940|SUPERIORITY||Ratio of rates|1.08||||0.5651|TWO_SIDED|95.0|0.82|1.43||2-sided|Generalized Linear Model Analysis|||||1.43|0.82|0.5651
91681782|NCT02603393|183253941|SUPERIORITY||Ratio of rates|1.02||||0.9665|TWO_SIDED|95.0|0.44|2.34||2-sided|Generalized Linear Model Analysis|||||2.34|0.44|0.9665
91681783|NCT02603393|183253942|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.0573||95.0|-0.053|0.001||2-Sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0573
91681784|NCT02603393|183253943|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.0022||95.0|0.7|3.0||2-Sided|Mixed Model for Repeated Measures Analys|||||3.0|0.7|0.0022
91681785|NCT02603393|183253944|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.0221|TWO_SIDED|95.0|0.2|2.6||2-Sided|Mixed Model for Repeated measures Analys|||||2.6|0.2|0.0221
91681786|NCT02603393|183253945|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.1724||95.0|-0.587|0.105|||Mixed Model for Repeated Measures Analys|||||0.105|-0.587|0.1724
91681787|NCT02603393|183253946|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.1055||95.0|-0.638|0.061||2-Sided|Mixed Model for Repated Measures Analysi|||||0.061|-0.638|0.1055
91681788|NCT02603393|183253947|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.0641||95.0|-0.01|0.365||2-Sided|Linear Mixed Model Analysis|||||0.365|-0.010|0.0641
91681789|NCT02603393|183253948|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.4107|TWO_SIDED|95.0|-0.025|0.061||2-Sided|Mixed Model for Repeated Measures Analys|||||0.061|-0.025|0.4107
91681790|NCT04540406|183253974|OTHER|We employed covariate-adjusted Principal Coordinates Analysis and a subject-stratified PERMANOVA test to assess the overall gut microbiota structural change. These tests are generally neither superiority, non-inferiority, nor equivalence tests. Instead, they are used to detect and evaluate overall differences in the microbial community structure between groups or conditions.||||||||||||||||PCoA (Principal Coordinates Analysis) + PERMANOVA (Permutational Multivariate Analysis of Variance) are exploratory multivariate techniques commonly used in microbiome research to assess and visualize differences in community composition. The null hypothesis for PERMANOVA is that there are no differences in the centroids (multivariate means) of the groups being compared. The microbial communities in different groups or conditions are not significantly different from each other.|To assess the overall structural changes in gut microbiota, we employed covariate-adjusted Principal Coordinates Analysis (PCoA) and a subject-stratified PERMANOVA test. PCoA, an exploratory multivariate technique, helps visualize and interpret patterns in complex microbiome data by reducing dimensionality, with the first principal coordinate (PC1) capturing the largest variation among samples. PERMANOVA, which does not rely on standard parametric assumptions, was used to determine if there are statistically significant differences in the overall composition of microbial communities between groups based on a chosen distance metric. Our analysis aimed to explore whether microbial community compositions differed significantly between Day 0 and Day 28 within the Treatment group, accounting for inter-individual variability. Similarly, we investigated if such differences existed over the same time points in the Control group. The unit of measure was distance metrics.|||
91681791|NCT01517373|183254001|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.145||0.4468|TWO_SIDED|80.0|-0.21|0.17||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.17|-0.21|0.4468
91681792|NCT01517373|183254001|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.0218|TWO_SIDED|80.0|-0.48|-0.11||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.11|-0.48|0.0218
91718583|NCT01668797|183329878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0462|TWO_SIDED|95.0|-3.15|0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.03|-3.15|0.0462
91718584|NCT01668797|183329878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0074|TWO_SIDED|95.0|-3.94|-0.64|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.64|-3.94|0.0074
91681793|NCT01517373|183254001|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.144||0.0006|TWO_SIDED|80.0|-0.65|-0.28||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.28|-0.65|0.0006
91681794|NCT01517373|183254001|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|80.0|-1.02|-0.65||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.65|-1.02|<0.0001
91681795|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.087||0.6112|TWO_SIDED|80.0|-0.09|0.14||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.14|-0.09|0.6112
91681796|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.088||0.055|TWO_SIDED|80.0|-0.25|-0.03||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.03|-0.25|0.0550
91681797|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.086||0.0032|TWO_SIDED|80.0|-0.35|-0.13||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.13|-0.35|0.0032
91681798|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.086|<|0.0001|TWO_SIDED|80.0|-0.55|-0.33||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.33|-0.55|<0.0001
91681799|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.101||0.6146|TWO_SIDED|80.0|-0.1|0.16||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.16|-0.10|0.6146
91681800|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.2606|TWO_SIDED|80.0|-0.19|0.06||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.19|0.2606
91681801|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.099||0.0006|TWO_SIDED|80.0|-0.45|-0.2||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0006
91681802|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|80.0|-0.7|-0.44||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.44|-0.70|<0.0001
91681803|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.118||0.6618|TWO_SIDED|80.0|-0.1|0.2||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.20|-0.10|0.6618
91681804|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.119||0.0878|TWO_SIDED|80.0|-0.31|-0.01||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-0.31|0.0878
91487322|NCT00717093|182847168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.59|3.58||p-values obtained from logistic regression model including main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values imputed as negative|Odds ratio obtained from logistic regression model including main effects of treatment and center|||3.58|1.59|<0.0001
91681805|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.117||0.0022|TWO_SIDED|80.0|-0.49|-0.19||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.19|-0.49|0.0022
91681806|NCT01517373|183254002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.117|<|0.0001|TWO_SIDED|80.0|-0.81|-0.51||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.51|-0.81|<0.0001
91681807|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|5.222||0.3446|TWO_SIDED|80.0|-8.8|4.62||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.62|-8.80|0.3446
91718585|NCT01668797|183329878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0136|TWO_SIDED|95.0|-6.05|-0.75|||Mixed Models Analysis|||Statistical analysis at Week 52||-0.75|-6.05|0.0136
91526852|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.6||||0.023|TWO_SIDED|95.0|0.08|1.11||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.11|0.08|0.023
91681808|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.12|STANDARD_ERROR_OF_MEAN|5.21||0.1204|TWO_SIDED|80.0|-12.81|0.57||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-12.81|0.1204
91681809|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.74|STANDARD_ERROR_OF_MEAN|5.166||0.0041|TWO_SIDED|80.0|-20.37|-7.1||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.10|-20.37|0.0041
91681810|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.34|STANDARD_ERROR_OF_MEAN|5.192|<|0.0001|TWO_SIDED|80.0|-28.01|-14.67||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-14.67|-28.01|<0.0001
91681811|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.14|STANDARD_ERROR_OF_MEAN|5.191||0.1616|TWO_SIDED|80.0|-11.8|1.53||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.53|-11.80|0.1616
91681812|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|STANDARD_ERROR_OF_MEAN|5.219||0.1974|TWO_SIDED|80.0|-11.15|2.26||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.26|-11.15|0.1974
91681813|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|5.14||0.0122|TWO_SIDED|80.0|-18.22|-5.02||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.02|-18.22|0.0122
91681814|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.79|STANDARD_ERROR_OF_MEAN|5.129|<|0.0001|TWO_SIDED|80.0|-31.37|-18.2||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-18.20|-31.37|<0.0001
91681815|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|5.674||0.3645|TWO_SIDED|80.0|-9.26|5.32||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.32|-9.26|0.3645
91681816|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|5.676||0.3672|TWO_SIDED|80.0|-9.22|5.36||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.22|0.3672
91681817|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|5.598||0.0906|TWO_SIDED|80.0|-14.69|-0.31||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.31|-14.69|0.0906
91681818|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.69|STANDARD_ERROR_OF_MEAN|5.624||0.0003|TWO_SIDED|80.0|-26.91|-12.46||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.46|-26.91|0.0003
91681819|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.18|STANDARD_ERROR_OF_MEAN|5.534||0.1748|TWO_SIDED|80.0|-12.29|1.93||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.93|-12.29|0.1748
91681820|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.54|STANDARD_ERROR_OF_MEAN|5.566||0.0297|TWO_SIDED|80.0|-17.69|-3.38||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.38|-17.69|0.0297
91718586|NCT01668797|183329878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.0001|TWO_SIDED|95.0|-2.84|-0.97|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.97|-2.84|0.0001
91718587|NCT01668797|183329879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0695|TWO_SIDED|95.0|-2.26|0.09|||ANCOVA|||Statistical analysis at Week 6.||0.09|-2.26|0.0695
91718588|NCT01668797|183329879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.0089|TWO_SIDED|95.0|-3.38|-0.49|||ANCOVA|||Statistical analysis at Week 12.||-0.49|-3.38|0.0089
91718589|NCT01668797|183329879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83||||0.0004|TWO_SIDED|95.0|-4.39|-1.27|||ANCOVA|||Statistical analysis at Week 24.||-1.27|-4.39|0.0004
91681821|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|5.469||0.0118|TWO_SIDED|80.0|-19.47|-5.41||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.41|-19.47|0.0118
91681822|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.0|STANDARD_ERROR_OF_MEAN|5.48|<|0.0001|TWO_SIDED|80.0|-34.04|-19.96||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-19.96|-34.04|<0.0001
91681823|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.03|STANDARD_ERROR_OF_MEAN|6.281||0.1012|TWO_SIDED|80.0|-16.1|0.04||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.04|-16.10|0.1012
91681824|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.99|STANDARD_ERROR_OF_MEAN|6.287||0.0409|TWO_SIDED|80.0|-19.07|-2.91|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.91|-19.07|0.0409
91681825|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.87|STANDARD_ERROR_OF_MEAN|6.232||0.0089|TWO_SIDED|80.0|-22.88|-6.86|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-6.86|-22.88|0.0089
91681826|NCT01517373|183254003|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.93|STANDARD_ERROR_OF_MEAN|6.233|<|0.0001|TWO_SIDED|80.0|-33.93|-17.92||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-17.92|-33.93|<0.0001
91681827|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.196||0.0898|TWO_SIDED|80.0|0.08|0.59||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|0.08|0.0898
91681828|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.195||0.0555|TWO_SIDED|80.0|0.12|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|0.12|0.0555
91681829|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0585|TWO_SIDED|80.0|0.12|0.61||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.61|0.12|0.0585
91681830|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.194||0.0454|TWO_SIDED|80.0|0.14|0.64||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.64|0.14|0.0454
91681831|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.235||0.2819|TWO_SIDED|80.0|-0.05|0.55||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-0.05|0.2819
91681832|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.235||0.0319|TWO_SIDED|80.0|0.2|0.81||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.81|0.20|0.0319
91681833|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.231||0.1835|TWO_SIDED|80.0|0.01|0.6||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.60|0.01|0.1835
91681834|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|0.231||0.0001|TWO_SIDED|80.0|0.63|1.22||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.22|0.63|0.0001
91681835|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.9689|TWO_SIDED|80.0|-0.35|0.33||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.33|-0.35|0.9689
91681836|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.265||0.2221|TWO_SIDED|80.0|-0.02|0.67||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.02|0.2221
91718590|NCT01668797|183329879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.0001|TWO_SIDED|95.0|-4.63|-1.54|||ANCOVA|||Statistical analysis at Week 36.||-1.54|-4.63|0.0001
91718591|NCT01668797|183329879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|||<|0.0001|TWO_SIDED|95.0|-4.99|-1.89|||ANCOVA|||Statistical analysis at Week 52.||-1.89|-4.99|<0.0001
91681837|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.261||0.2774|TWO_SIDED|80.0|-0.05|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.05|0.2774
91681838|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|80.0|0.76|1.43||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.43|0.76|<0.0001
91681839|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.314||0.0667|TWO_SIDED|80.0|0.17|0.98||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.98|0.17|0.0667
91681840|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.314||0.0133|TWO_SIDED|80.0|0.38|1.19||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.19|0.38|0.0133
91681841|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.308||0.026|TWO_SIDED|80.0|0.29|1.08||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|0.29|0.0260
91681842|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|80.0|1.23|2.02||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.02|1.23|<0.0001
91681843|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.374||0.0335|TWO_SIDED|80.0|0.32|1.28||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.28|0.32|0.0335
91681844|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.373||0.1557|TWO_SIDED|80.0|0.05|1.01||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.01|0.05|0.1557
91681845|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|0.368||0.0132|TWO_SIDED|80.0|0.45|1.39||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.39|0.45|0.0132
91681846|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|80.0|2.2|3.15||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.15|2.20|<0.0001
91718592|NCT01668797|183329880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1969|TWO_SIDED|95.0|-1.66|0.35|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.35|-1.66|0.1969
91718593|NCT01668797|183329880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.2007|TWO_SIDED|95.0|-2.04|0.43|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.43|-2.04|0.2007
91526853|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.47||||0.072|TWO_SIDED|95.0|-0.04|0.98||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.98|-0.04|0.072
91681847|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.394||0.0158|TWO_SIDED|80.0|0.45|1.46||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.46|0.45|0.0158
91681848|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.392||0.2132|TWO_SIDED|80.0|-0.01|0.99||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.99|-0.01|0.2132
91681849|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.387||0.0263|TWO_SIDED|80.0|0.37|1.36||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.36|0.37|0.0263
91718594|NCT01668797|183329880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0436|TWO_SIDED|95.0|-2.3|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.03|-2.30|0.0436
91718595|NCT01668797|183329880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0444|TWO_SIDED|95.0|-2.97|-0.04|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.04|-2.97|0.0444
91718596|NCT01668797|183329880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.8927|TWO_SIDED|95.0|-4.4|5.02|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.02|-4.40|0.8927
91718597|NCT01668797|183329880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2154|TWO_SIDED|95.0|-1.34|0.31|||Mixed Models Analysis|||Statistical analysis at across visits.||0.31|-1.34|0.2154
91718598|NCT01668797|183329881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0707|TWO_SIDED|95.0|-1.78|0.07|||ANCOVA|||Statistical analysis at Week 6.||0.07|-1.78|0.0707
91718599|NCT01668797|183329881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0276|TWO_SIDED|95.0|-2.35|-0.14|||ANCOVA|||Statistical analysis at Week 12.||-0.14|-2.35|0.0276
91718600|NCT01668797|183329881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0065|TWO_SIDED|95.0|-2.72|-0.45|||ANCOVA|||Statistical analysis at Week 24.||-0.45|-2.72|0.0065
91718601|NCT01668797|183329881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0085|TWO_SIDED|95.0|-2.84|-0.42|||ANCOVA|||Statistical analysis at Week 36.||-0.42|-2.84|0.0085
91718602|NCT01668797|183329881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.063|TWO_SIDED|95.0|-2.52|0.07|||ANCOVA|||Statistical analysis at Week 52.||0.07|-2.52|0.0630
91718603|NCT01668797|183329882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.2251|TWO_SIDED|95.0|-1.33|0.31|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.31|-1.33|0.2251
91718604|NCT01668797|183329882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.0368|TWO_SIDED|95.0|-2.19|-0.07|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.07|-2.19|0.0368
91718605|NCT01668797|183329882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0024|TWO_SIDED|95.0|-2.51|-0.56|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.56|-2.51|0.0024
91718606|NCT01668797|183329882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.0293|TWO_SIDED|95.0|-2.8|-0.15|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.15|-2.80|0.0293
91718607|NCT01668797|183329882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.9632|TWO_SIDED|95.0|-3.32|3.17|||Mixed Models Analysis|||Statistical analysis at Week 52.||3.17|-3.32|0.9632
91718608|NCT01668797|183329882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.0029|TWO_SIDED|95.0|-1.63|-0.34|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.34|-1.63|0.0029
91718609|NCT01668797|183329883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.1062|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.44|0.1062
91718610|NCT01668797|183329883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.0051|TWO_SIDED|95.0|-2.33|-0.42|||ANCOVA|||Statistical analysis at Week 12.||-0.42|-2.33|0.0051
91718611|NCT01668797|183329883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.0001|TWO_SIDED|95.0|-3.08|-1.01|||ANCOVA|||Statistical analysis at Week 24.||-1.01|-3.08|0.0001
91718612|NCT01668797|183329883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.0004|TWO_SIDED|95.0|-3.0|-0.89|||ANCOVA|||Statistical analysis at Week 36.||-0.89|-3.00|0.0004
91718613|NCT01668797|183329883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.0035|TWO_SIDED|95.0|-2.81|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.81|0.0035
91718614|NCT01668797|183329884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1465|TWO_SIDED|95.0|-0.85|0.13|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.13|-0.85|0.1465
91718615|NCT01668797|183329884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2154|TWO_SIDED|95.0|-1.27|0.29|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.29|-1.27|0.2154
91718616|NCT01668797|183329884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2696|TWO_SIDED|95.0|-1.23|0.35|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.35|-1.23|0.2696
91718617|NCT01668797|183329884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0179|TWO_SIDED|95.0|-1.95|-0.19|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.19|-1.95|0.0179
91718618|NCT01668797|183329884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0875|TWO_SIDED|95.0|-2.46|0.18|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.18|-2.46|0.0875
91718619|NCT01668797|183329884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0021|TWO_SIDED|95.0|-1.08|-0.24|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.24|-1.08|0.0021
91718620|NCT01668797|183329885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2135|TWO_SIDED|95.0|-0.86|0.19|||ANCOVA|||Statistical analysis at Week 6.||0.19|-0.86|0.2135
91718621|NCT01668797|183329885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.2437|TWO_SIDED|95.0|-1.13|0.29|||ANCOVA|||Statistical analysis at Week 12.||0.29|-1.13|0.2437
91718622|NCT01668797|183329885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0635|TWO_SIDED|95.0|-1.66|0.05|||ANCOVA|||Statistical analysis at Week 24.||0.05|-1.66|0.0635
91718623|NCT01668797|183329885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0144|TWO_SIDED|95.0|-1.92|-0.22|||ANCOVA|||Statistical analysis at Week 36.||-0.22|-1.92|0.0144
91718624|NCT01668797|183329885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0046|TWO_SIDED|95.0|-2.12|-0.39|||ANCOVA|||Statistical analysis at Week 52.||-0.39|-2.12|0.0046
91718625|NCT01668797|183329886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.164|TWO_SIDED|95.0|-1.14|0.19|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.19|-1.14|0.1640
91718626|NCT01668797|183329886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5466|TWO_SIDED|95.0|-1.04|0.55|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.55|-1.04|0.5466
91718627|NCT01668797|183329886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9417|TWO_SIDED|95.0|-0.81|0.87|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.87|-0.81|0.9417
91718628|NCT01668797|183329886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6257|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.76|-1.25|0.6257
91718629|NCT01668797|183329886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7437|TWO_SIDED|95.0|-1.68|1.21|||Mixed Models Analysis|||Statistical analysis at Week 52.||1.21|-1.68|0.7437
91718630|NCT01668797|183329886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.4506|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||Statistical analysis at across visits.||0.28|-0.62|0.4506
91718631|NCT01668797|183329887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0467|TWO_SIDED|95.0|-1.32|-0.06|||ANCOVA|||Statistical analysis at Week 6.||-0.06|-1.32|0.0467
91718632|NCT01668797|183329887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1599|TWO_SIDED|95.0|-1.33|0.22|||ANCOVA|||Statistical analysis at Week 12.||0.22|-1.33|0.1599
91718633|NCT01668797|183329887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.1417|TWO_SIDED|95.0|-1.35|0.19|||ANCOVA|||Statistical analysis at Week 24.||0.19|-1.35|0.1417
91718634|NCT01668797|183329887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0724|TWO_SIDED|95.0|-1.47|0.06|||ANCOVA|||Statistical analysis at Week 36.||0.06|-1.47|0.0724
91718635|NCT01668797|183329887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0608|TWO_SIDED|95.0|-1.47|0.03|||ANCOVA|||Statistical analysis at Week 52.||0.03|-1.47|0.0608
91718636|NCT00062166|183329918|NON_INFERIORITY|Time dependent risk for requiring an intervention for pancreatic neuroendocrine tumors (PNET), among 63 patients with PNETs with diameter \>1.2 and \<3 cm, and a known position of germline VHL pathogenic variant (n=63). Comparison between exon 3 vs exon 1 and 2.|Hazard Ratio (HR)|3.3||||0.02|TWO_SIDED|95.0|1.2|9.1|||Regression, Cox|||||9.1|1.2|0.02
91718637|NCT06119854|183329935|OTHER||Risk Ratio (RR)|1.207|||||TWO_SIDED|95.0|0.406|3.59|||||The CBT arm is the numerator and the standard arm is the denominator.|||3.590|0.406|
91681850|NCT01517373|183254011|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|80.0|2.12|3.12||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|2.12|<0.0001
91681851|NCT03149445|183254016|SUPERIORITY||LS Mean Difference|-5.4||||0.1045|TWO_SIDED|95.0|-12.3|1.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||1.5|-12.3|0.1045
91681852|NCT03149445|183254016|SUPERIORITY||LS Mean Difference|0.7||||0.7422|TWO_SIDED|95.0|-4.0|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-4.0|0.7422
91681853|NCT03149445|183254016|SUPERIORITY||LS Mean Difference|5.6||||0.046|TWO_SIDED|95.0|0.1|11.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.0|0.1|0.0460
91681854|NCT03149445|183254016|SUPERIORITY||LS Mean Difference|4.3||||0.3847|TWO_SIDED|95.0|-9.2|17.8||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||17.8|-9.2|0.3847
91681855|NCT03149445|183254017|SUPERIORITY||LS Mean Difference|-6.2||||0.1326|TWO_SIDED|95.0|-14.9|2.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||2.5|-14.9|0.1326
91681856|NCT03149445|183254017|SUPERIORITY||LS Mean Difference|1.2||||0.5148|TWO_SIDED|95.0|-2.9|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-2.9|0.5148
91681857|NCT03149445|183254017|SUPERIORITY||LS Mean Difference|4.5||||0.0605|TWO_SIDED|95.0|-0.3|9.4||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.4|-0.3|0.0605
91681858|NCT03149445|183254017|SUPERIORITY||LS Mean Difference|2.6||||0.5198|TWO_SIDED|95.0|-8.8|14.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||14.0|-8.8|0.5198
91681859|NCT03149445|183254018|SUPERIORITY||LS Mean Difference|-8.1||||0.0058|TWO_SIDED|95.0|-12.5|-3.6||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||-3.6|-12.5|0.0058
91681860|NCT03149445|183254018|SUPERIORITY||LS Mean Difference|2.1||||0.5142|TWO_SIDED|95.0|-5.3|9.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.5|-5.3|0.5142
91681861|NCT03149445|183254018|SUPERIORITY||LS Mean Difference|3.1||||0.3794|TWO_SIDED|95.0|-5.1|11.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.3|-5.1|0.3794
91681862|NCT03149445|183254018|SUPERIORITY||LS Mean Difference|1.0||||0.685|TWO_SIDED|95.0|-6.1|8.1||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||8.1|-6.1|0.6850
91681863|NCT02699060|183254032|SUPERIORITY||Median Difference (Net)|-1.76|STANDARD_DEVIATION|0.8||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
91527610|NCT01976364|182930478|OTHER||Difference in percentage of participants|3.97|||||TWO_SIDED|95.0|-10.58|18.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.52|-10.58|
91681864|NCT04916444|183254033|SUPERIORITY|||||||0.691|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the TWSTRS scores.||||0.691
91681865|NCT04916444|183254034|SUPERIORITY|||||||0.816|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the BDI scores.||||0.816
91718638|NCT06119854|183329935|OTHER||Risk Difference (RD)|0.003|||||TWO_SIDED|95.0|-0.013|0.018|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.018|-0.013|
91718639|NCT06119854|183329935|OTHER||Risk Ratio (RR)|0.687|||||TWO_SIDED|95.0|0.194|2.436|||||The inoculation arm is the numerator and the standard arm is the denominator.|||2.436|0.194|
91718640|NCT06119854|183329935|OTHER||Risk Difference (RD)|-0.004|||||TWO_SIDED|95.0|-0.018|0.01|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.010|-0.018|
91718641|NCT06119854|183329936|OTHER||Risk Ratio (RR)|0.992|||||TWO_SIDED|95.0|0.785|1.253|||||The CBT arm is the numerator and the standard arm is the denominator.|||1.253|0.785|
91718642|NCT06119854|183329936|OTHER||Risk Difference (RD)|-0.003|||||TWO_SIDED|95.0|-0.063|0.058|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.058|-0.063|
91718643|NCT06119854|183329936|OTHER||Risk Ratio (RR)|1.227|||||TWO_SIDED|95.0|0.981|1.534|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.534|0.981|
91718644|NCT06119854|183329936|OTHER||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|0.008|0.133|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.133|0.008|
91681866|NCT04916444|183254035|SUPERIORITY|||||||0.167|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.167
91681867|NCT04916444|183254036|SUPERIORITY|||||||0.507|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.507
91681868|NCT04916444|183254037|SUPERIORITY|||||||0.056|||||||ANOVA|Two-way repeated measures ANOVA||||||0.056
91681869|NCT04916444|183254038|SUPERIORITY|||||||0.646|||||||ANOVA|Two-way repeated measures ANOVA||||||0.646
91681870|NCT05005312|183254039|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|101.96|||||TWO_SIDED|90.0|74.2|140.11|||ANOVA|||||140.11|74.20|
91681871|NCT05005312|183254040|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|99.29|||||TWO_SIDED|90.0|70.81|139.21|||ANOVA|||||139.21|70.81|
91681872|NCT05005312|183254041|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|98.78|||||TWO_SIDED|90.0|70.65|138.12|||ANOVA|||||138.12|70.65|
91718645|NCT06119854|183329937|OTHER||Risk Ratio (RR)|1.063|||||TWO_SIDED|95.0|0.74|1.527|||||CBT group represents the numerator and standard (conventional) represents the denominator|||1.527|0.740|
91718646|NCT06119854|183329937|OTHER||Risk Difference (RD)|0.008|||||TWO_SIDED|95.0|-0.037|0.053|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm|||0.053|-0.037|
91718647|NCT06119854|183329937|OTHER||Risk Ratio (RR)|1.262|||||TWO_SIDED|95.0|0.892|1.784|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.784|0.892|
91718648|NCT06119854|183329937|OTHER||Risk Difference (RD)|0.034|||||TWO_SIDED|95.0|-0.013|0.08|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.080|-0.013|
91718649|NCT06119854|183329938|OTHER||Risk Ratio (RR)|1.131|||||TWO_SIDED|95.0|0.911|1.406|||||CBT arm is the numerator and the standard arm is the denominator.|||1.406|0.911|
91718650|NCT06119854|183329938|OTHER||Risk Difference (RD)|0.045|||||TWO_SIDED|95.0|-0.019|0.109|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.109|-0.019|
91718651|NCT06119854|183329938|OTHER||Risk Ratio (RR)|1.323|||||TWO_SIDED|95.0|1.074|1.631|||||the inoculation arm is the numerator and the standard arm is the denominator.|||1.631|1.074|
91718652|NCT06119854|183329938|OTHER||Risk Difference (RD)|0.111|||||TWO_SIDED|95.0|0.045|0.176|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.176|0.045|
91718653|NCT06494761|183329940|OTHER||Ratios of adjusted geometric means [%]|110.98|||||TWO_SIDED|90.0|96.9|127.1|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 22.1|The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered with a single dose of zongertinib (Test Treatment 1) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||127.10|96.90|
91718654|NCT06494761|183329940|OTHER||Ratios of adjusted geometric means [%]|130.1|||||TWO_SIDED|90.0|110.35|153.39|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 25.2|The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered after multiple doses of zongertinib (Test Treatment 3) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||153.39|110.35|
91718655|NCT06494761|183329941|OTHER||Ratios of adjusted geometric means [%]|107.8|||||TWO_SIDED|90.0|98.57|117.9|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 13.5|The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||117.90|98.57|
91718656|NCT06494761|183329941|OTHER||Ratios of adjusted geometric means [%]|105.62|||||TWO_SIDED|90.0|95.41|116.93|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.4|The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||116.93|95.41|
91718657|NCT06494761|183329942|OTHER||Ratios of adjusted geometric means [%]|96.55|||||TWO_SIDED|90.0|75.96|122.72|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 24.5|The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||122.72|75.96|
91718658|NCT06494761|183329942|OTHER||Ratios of adjusted geometric means [%]|89.75|||||TWO_SIDED|90.0|61.86|130.2|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 39.6|The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||130.20|61.86|
91718659|NCT06494761|183329943|OTHER||Ratios of adjusted geometric means [%]|117.07|||||TWO_SIDED|90.0|105.56|129.84|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 16.8|The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered with a single dose of zongertinib (Test Treatment 1) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||129.84|105.56|
91718660|NCT06494761|183329943|OTHER||Ratios of adjusted geometric means [%]|144.36|||||TWO_SIDED|90.0|123.53|168.71|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 23.9|The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered after multiple doses of zongertinib (Test Treatment 3) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||168.71|123.53|
91527611|NCT01976364|182930478|OTHER||Difference in percentage of participants|2.87|||||TWO_SIDED|95.0|-11.63|17.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.37|-11.63|
91681873|NCT06077149|183254048|NON_INFERIORITY|The primary outcome of the study was to demonstrate the noninferiority in antibody response at 30 days for any RSV vaccine between the LTCF group and the community group. A sample size of 152 participants (76 per group) was expected to provide 80% power to demonstrate noninferiority of 1 month GMT to within a relative noninferiority margin of 1.5-fold using a 1-sided 0.05-level linear model-based t test comparing log (1-month titer) by population, adjusted for vaccine and log (baseline titer).||||||0.14|||||||t-test, 2 sided|||||||0.14
91681874|NCT06077149|183254049|NON_INFERIORITY|The primary outcome of the study was to demonstrate the noninferiority in antibody response at 30 days for any RSV vaccine between the LTCF group and the community group. A sample size of 152 participants (76 per group) was expected to provide 80% power to demonstrate noninferiority of 1 month GMT to within a relative noninferiority margin of 1.5-fold using a 1-sided 0.05-level linear model-based t test comparing log (1-month titer) by population, adjusted for vaccine and log (baseline titer).||||||0.17|||||||t-test, 2 sided|||||||0.17
91681875|NCT06077149|183254050|NON_INFERIORITY|The primary outcome of the study was to demonstrate the noninferiority in antibody response at 30 days for any RSV vaccine between the LTCF group and the community group. A sample size of 152 participants (76 per group) was expected to provide 80% power to demonstrate noninferiority of 1 month GMT to within a relative noninferiority margin of 1.5-fold using a 1-sided 0.05-level linear model-based t test comparing log (1-month titer) by population, adjusted for vaccine and log (baseline titer).||||||0.32|||||||t-test, 2 sided|||||||0.32
91681876|NCT06077149|183254051|NON_INFERIORITY|The primary outcome of the study was to demonstrate the noninferiority in antibody response at 30 days for any RSV vaccine between the LTCF group and the community group. A sample size of 152 participants (76 per group) was expected to provide 80% power to demonstrate noninferiority of 1 month GMT to within a relative noninferiority margin of 1.5-fold using a 1-sided 0.05-level linear model-based t test comparing log (1-month titer) by population, adjusted for vaccine and log (baseline titer).||||||0.82|||||||t-test, 2 sided|||||||0.82
91681877|NCT02970318|183254058|OTHER||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.2|0.49||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.49|0.20|<0.0001
91681878|NCT02970318|183254059|OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.38||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.38|0.20|<0.0001
91681879|NCT02970318|183254060|OTHER||Risk Difference (RD)|5.8||||0.2248|TWO_SIDED|95.0|-3.3|14.9|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||14.9|-3.3|0.2248
91681880|NCT02970318|183254061|OTHER||Risk Difference (RD)|-1.3||||0.734|TWO_SIDED|95.0|-9.6|7.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||7.0|-9.6|0.7340
91681881|NCT02970318|183254062|OTHER||Hazard Ratio (HR)|0.69||||0.0783|TWO_SIDED|95.0|0.46|1.04|||Log Rank|Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).||1.04|0.46|0.0783
91681882|NCT02970318|183254063|OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.59||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.59|0.19|<0.0001
91681883|NCT02970318|183254064|OTHER||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.16|0.33||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.33|0.16|<0.0001
91681884|NCT02970318|183254065|OTHER||Hazard Ratio (HR)|0.29|||<|0.0001|TWO_SIDED|95.0|0.21|0.4||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.40|0.21|<0.0001
91681885|NCT02500641|183254100|SUPERIORITY|||||||0.5298|||||||ANCOVA|||||||0.5298
91681886|NCT02036775|183254137|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|110.68|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|99.84|122.69|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||122.69|99.84|
91681887|NCT02036775|183254137|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
91681888|NCT02036775|183254137|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|106.93|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|100.29|114.02|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||114.02|100.29|
91681889|NCT02036775|183254138|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|84.72|STANDARD_DEVIATION|19.01|||TWO_SIDED|90.0|76.96|93.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||93.25|76.96|
91681890|NCT02036775|183254138|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|103.87|STANDARD_DEVIATION|17.19|||TWO_SIDED|90.0|95.22|113.31|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||113.31|95.22|
91681891|NCT02036775|183254138|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|80.94|STANDARD_DEVIATION|17.95|||TWO_SIDED|90.0|73.92|88.62|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||88.62|73.92|
91681892|NCT02036775|183254139|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|88.54|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|79.87|98.15|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||98.15|79.87|
91681893|NCT02036775|183254139|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
91681894|NCT02036775|183254139|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|85.55|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|80.23|91.22|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||91.22|80.23|
91681895|NCT02036775|183254140|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|76.55|STANDARD_DEVIATION|14.55|||TWO_SIDED|90.0|71.1|82.4|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||82.40|71.10|
91681896|NCT02036775|183254140|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|100.46|STANDARD_DEVIATION|11.65|||TWO_SIDED|90.0|94.69|106.58|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||106.58|94.69|
91681897|NCT02036775|183254140|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|75.69|STANDARD_DEVIATION|15.64|||TWO_SIDED|90.0|69.92|81.93|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||81.93|69.92|
91526854|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.13||||0.551|TWO_SIDED|95.0|-0.29|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.29|0.551
91681898|NCT04181723|183254150|SUPERIORITY||LSM difference|-3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0175|TWO_SIDED|95.0|-5.7|-0.6|||Mixed-effects model for repeated measure|||||-0.6|-5.7|0.0175
91681899|NCT04181723|183254151|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.5|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-0.5|0.0030
91681900|NCT04181723|183254152|SUPERIORITY||LSM difference|1.0|STANDARD_ERROR_OF_MEAN|0.37||0.0064|TWO_SIDED|95.0|0.3|1.7|||Mixed-effects model for repeated measure|||||1.7|0.3|0.0064
91681901|NCT04181723|183254153|SUPERIORITY||LSM difference|-4.5|STANDARD_ERROR_OF_MEAN|4.67||0.3376|TWO_SIDED|95.0|-13.8|4.8|||ANCOVA|||||4.8|-13.8|0.3376
91681902|NCT04181723|183254154|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3649|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.3649
91681903|NCT04181723|183254155|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2114|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.2114
91681904|NCT04181723|183254156|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0257|TWO_SIDED|95.0|-0.6|0.0|||Mixed-effects model for repeated measure|||||0.0|-0.6|0.0257
91681905|NCT04181723|183254157|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9799|TWO_SIDED|95.0|-0.2|0.2|||Mixed-effects model for repeated measure|||||0.2|-0.2|0.9799
91681906|NCT04181723|183254158|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5304|TWO_SIDED|95.0|-0.1|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.1|0.5304
91681907|NCT04181723|183254159|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|1.4||0.5855|TWO_SIDED|95.0|-3.5|2.0|||ANCOVA|||||2.0|-3.5|0.5855
91681908|NCT04181723|183254160|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2507|TWO_SIDED|95.0|-0.1|0.4|||Mixed-effects model for repeated measure|||||0.4|-0.1|0.2507
91681909|NCT03496610|183254161|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed given non-normal distribution of data by Shapiro Wilks Test. Null hypothesis is that there is no difference in oral morphine equivalent consumption between the two groups in the first 24hrs after surgery. Original sample size calculation based on α=0.05, β=0.8, difference in means=2, and effect size of 1.0.||||0.81
91487323|NCT00717093|182847169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0118|TWO_SIDED|95.0|1.12|2.58||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values were imputed as negative|Odds Ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.58|1.12|0.0118
91527612|NCT01976364|182930479|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.5|
91718661|NCT06494761|183329944|OTHER||Ratios of adjusted geometric means [%]|110.74|||||TWO_SIDED|90.0|100.92|121.52|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 14.1|The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||121.52|100.92|
91681910|NCT03496610|183254162|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference between the two groups in pain on postoperative day 7.||||0.40
91681911|NCT03496610|183254163|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference in bloating severity between the two groups.||||0.74
91681912|NCT03496610|183254164|OTHER|||||||0.38|||||||Chi-squared|Degrees of freedom = 1||Compared using the Likelihood ratio test with α=0.05. The null hypothesis was that there is no difference between the groups.||||0.38
91681913|NCT04156620|183254194|SUPERIORITY||Marginal difference|17.91|||<|0.0001|TWO_SIDED|95.0|10.12|25.71|||Regression, Logistic|||Week 16||25.71|10.12|<0.0001
91681914|NCT04156620|183254195|SUPERIORITY||Marginal difference|20.45|||<|0.0001|TWO_SIDED|95.0|14.45|26.44|||Regression, Logistic|||||26.44|14.45|<0.0001
91681915|NCT04156620|183254196|SUPERIORITY||LS mean change|-1.01|STANDARD_ERROR_OF_MEAN|0.189|<|0.0001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|||Week 16||-0.64|-1.38|<0.0001
91681916|NCT04156620|183254197|SUPERIORITY||Marginal difference|22.15|||<|0.0001|TWO_SIDED|95.0|14.36|29.95|||Regression, Logistic|||||29.95|14.36|<0.0001
91681917|NCT04156620|183254198|SUPERIORITY||LS mean change|-0.94|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|-1.33|-0.56|||Mixed Models Analysis|||Week 16||-0.56|-1.33|<0.0001
91681918|NCT04156620|183254199|SUPERIORITY||LS mean change|3.01|STANDARD_ERROR_OF_MEAN|0.615|<|0.0001|TWO_SIDED|95.0|1.8|4.22|||Mixed Models Analysis|||Week 16||4.22|1.80|<0.0001
91681919|NCT04156620|183254200|SUPERIORITY||LS mean change|-1.77|STANDARD_ERROR_OF_MEAN|0.373|<|0.0001|TWO_SIDED|95.0|-2.51|-1.04|||Mixed Models Analysis|||Week 16||-1.04|-2.51|<0.0001
91681920|NCT04156620|183254201|SUPERIORITY||Relative LS mean change|0.44|||<|0.0001|TWO_SIDED|95.0|0.37|0.51|||Mixed Models Analysis|||Week 16||0.51|0.37|<0.0001
91681921|NCT04156620|183254202|SUPERIORITY||Marginal difference|23.41|||<|0.0001|TWO_SIDED|95.0|15.61|31.66|||Regression, Logistic|||||31.66|15.61|<0.0001
91681922|NCT04156620|183254203|SUPERIORITY||Marginal difference|12.58|||<|0.0001|TWO_SIDED|95.0|7.96|17.19|||Regression, Logistic|||Week 16||17.19|7.96|<0.0001
91681923|NCT04156620|183254204|SUPERIORITY||Marginal difference|10.56|||<|0.0001|TWO_SIDED|95.0|5.64|15.47|||Regression, Logistic|||||15.47|5.64|<0.0001
91681924|NCT04156620|183254205|SUPERIORITY||LS mean change|-0.66|STANDARD_ERROR_OF_MEAN|0.292||0.0234|TWO_SIDED|95.0|-1.24|-0.09|||Regression, Logistic|||||-0.09|-1.24|0.0234
91718662|NCT06494761|183329944|OTHER||Ratios of adjusted geometric means [%]|117.19|||||TWO_SIDED|90.0|108.3|126.81|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 11.9|The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||126.81|108.30|
91718663|NCT06494761|183329945|OTHER||Ratios of adjusted geometric means [%]|79.39|||||TWO_SIDED|90.0|49.9|126.3|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 77.6|The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||126.30|49.90|
91718664|NCT06494761|183329945|OTHER||Ratios of adjusted geometric means [%]|62.07|||||TWO_SIDED|90.0|44.69|86.2|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 49.1|The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||86.20|44.69|
91681925|NCT01121666|183254206|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED|||||This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.|Shuirmann's TOST|||This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.||||0.0003
91681926|NCT01121666|183254207|SUPERIORITY_OR_OTHER|||||||0.2357|TWO_SIDED|||||Follicles of 12 mm|Wilcoxon (Mann-Whitney)|||||||0.2357
91681927|NCT01121666|183254207|SUPERIORITY_OR_OTHER|||||||0.1395|TWO_SIDED|||||Follicles of 15 mm|Wilcoxon (Mann-Whitney)|||||||0.1395
91681928|NCT01121666|183254207|SUPERIORITY_OR_OTHER|||||||0.3992|TWO_SIDED|||||Follicles of 17 mm|Wilcoxon (Mann-Whitney)|||||||0.3992
91681929|NCT01121666|183254209|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9638
91681930|NCT01121666|183254214|SUPERIORITY_OR_OTHER|||||||0.8926|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8926
91681931|NCT01121666|183254221|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED||||||Shuirmann's TOST|||||||0.0003
91681932|NCT01629966|183254303|SUPERIORITY||Least Squares Mean Difference|-1.27||||0.083|TWO_SIDED|95.0|-2.71|0.17|||MMRM|||||0.17|-2.71|0.0830
91681933|NCT01629966|183254303|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.0156|TWO_SIDED|95.0|-3.26|-0.34|||MMRM|||||-0.34|-3.26|0.0156
91526855|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.54||||0.047|TWO_SIDED|95.0|0.01|1.08||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.08|0.01|0.047
91681934|NCT01629966|183254304|SUPERIORITY||Least Squares Mean Difference|-1.37||||0.0536|TWO_SIDED|95.0|-2.75|0.02|||MMRM|||||0.02|-2.75|0.0536
91681935|NCT01629966|183254304|SUPERIORITY||Least Squares Mean Difference|-1.52||||0.0349|TWO_SIDED|95.0|-2.94|-0.11|||MMRM|||||-0.11|-2.94|0.0349
91487324|NCT00717093|182847170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0063|TWO_SIDED|95.0|1.17|2.67|||Regression, Logistic|Missing salivary cotinine values were imputed as negative.||||2.67|1.17|0.0063
91681936|NCT01150890|183254305|SUPERIORITY|||||||0.1941|||||||Overall Trend test|||The primary null hypothesis was tested sequentially using a linear trend test at the significance level of 0.05 (two-sided) using logistic regression modeling.||||0.1941
91681937|NCT01150890|183254305|SUPERIORITY||Difference in Response Rate|0.0||||1|TWO_SIDED|95.0|-0.09|0.09|||Chi-squared|||||0.09|-0.09|1.0000
91681938|NCT01150890|183254305|SUPERIORITY||Difference in Response Rate|0.1203||||0.0966|TWO_SIDED|95.0|-0.02|0.26|||Chi-squared|||||0.26|-0.02|0.0966
91681939|NCT01150890|183254305|SUPERIORITY||Difference in Response Rate|0.0597||||0.3208|TWO_SIDED|95.0|-0.06|0.17|||Chi-squared|||||0.17|-0.06|0.3208
91681940|NCT01150890|183254306|SUPERIORITY||Difference in Response Rate|0.0363||||0.6831|TWO_SIDED|95.0|-0.14|0.21|||Chi-squared|||||0.21|-0.14|0.6831
91681941|NCT01150890|183254306|SUPERIORITY||Difference in Response Rate|0.1477||||0.1396|TWO_SIDED|95.0|-0.04|0.34|||Chi-squared|||||0.34|-0.04|0.1396
91681942|NCT01150890|183254306|SUPERIORITY||Difference in Response Rate|0.0265||||0.7588|TWO_SIDED|95.0|-0.14|0.19|||Chi-squared|||||0.19|-0.14|0.7588
91681943|NCT01150890|183254307|SUPERIORITY|||||||0.4161|||||||ANCOVA|Analysis of covariance (ANCOVA) model adjusted for baseline CDAI score.||||||0.4161
91681944|NCT01150890|183254307|SUPERIORITY|||||||0.8094|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.8094
91681945|NCT01150890|183254307|SUPERIORITY|||||||0.304|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.3040
91681946|NCT03118570|183254313|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed analysis of covariance (ANCOVA) model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.644
91527613|NCT01976364|182930479|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.6|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-1.6|
91681947|NCT03118570|183254313|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.485
91681948|NCT03118570|183254313|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.404
91681949|NCT03118570|183254314|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.006
91681950|NCT03118570|183254314|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.190
91681951|NCT03118570|183254314|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.704
91681952|NCT03118570|183254315|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.011
91681953|NCT03118570|183254315|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.047
91681954|NCT03118570|183254315|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.756
91681955|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.329||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.329
91681956|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.953||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.953
91681957|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
91681958|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.644
91681959|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.485
91681960|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.404
91681961|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.827||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.827
91681962|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.459||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.459
91681963|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.022||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.022
91681964|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.821||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.821
91681965|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.911||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.911
91681966|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.152||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.152
91681967|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.668||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.668
91681968|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.109
91681969|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.358||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.358
91681970|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.742||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.742
91681971|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.567||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.567
91681972|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.430
91681973|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.634||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.634
91681974|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.146||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.146
91681975|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.521||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.521
91681976|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.991||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.991
91526856|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.316|TWO_SIDED|95.0|-0.26|0.81||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.81|-0.26|0.316
91681977|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.069||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.069
91681978|NCT03118570|183254316|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.625||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.625
91681979|NCT03118570|183254317|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
91681980|NCT03118570|183254317|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.376||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.376
91681981|NCT03118570|183254317|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.259||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.259
91681982|NCT03118570|183254317|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.253||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.253
91681983|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.064||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.064
91681984|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.019||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.019
91718665|NCT06494761|183329946|OTHER||Ratios of adjusted geometric means [%]|110.86|||||TWO_SIDED|90.0|96.58|127.24|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 22.5|The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered with a single dose of zongertinib (Test Treatment 1) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||127.24|96.58|
91718666|NCT06494761|183329946|OTHER||Ratios of adjusted geometric means [%]|129.8|||||TWO_SIDED|90.0|109.7|153.59|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 25.8|The relative bioavailability of Repaglinide was assessed by comparing Repaglinide administered after multiple doses of zongertinib (Test Treatment 3) to Repaglinide administered alone (Reference Treatment 1). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||153.59|109.70|
91681985|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.845||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.845
91681986|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.006
91681987|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.190
91681988|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.704
91681989|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.002
91681990|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.021||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.021
91681991|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.504||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.504
91681992|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.462||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.462
91681993|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.134||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.134
91681994|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.086
91681995|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.199||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.199
91681996|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.219||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.219
91681997|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.112||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.112
91681998|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.086
91526857|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.224|TWO_SIDED|95.0|-0.17|0.71||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.71|-0.17|0.224
91681999|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.245||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.245
91682000|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.232||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.232
91682001|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.237||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.237
91682002|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.088
91682003|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.302||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.302
91682004|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.626||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.626
91682005|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.517||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.517
91682006|NCT03118570|183254318|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.262
91682007|NCT03118570|183254319|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
91682008|NCT03118570|183254319|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.004
91682009|NCT03118570|183254319|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.080
91682010|NCT03118570|183254319|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
91682011|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.06||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.060
91682012|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.015
91682013|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
91682014|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.011
91682015|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.047
91487325|NCT00717093|182847171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.52|3.41||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 12||3.41|1.52|<0.0001
91682016|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.756
91682017|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.006
91682018|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.137||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.137
91682019|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.639||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.639
91682020|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.325||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.325
91682021|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.108||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.108
91682022|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.078
91682023|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.106||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.106
91682024|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.236||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.236
91682025|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.164||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.164
91682026|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
91682027|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.224||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.224
91682028|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.291||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.291
91682029|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
91682030|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.188||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.188
91682031|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.503||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.503
91682032|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.385
91527614|NCT01976364|182930479|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-1.0|
91682033|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.727||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.727
91682034|NCT03118570|183254320|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.338||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.338
91682035|NCT03118570|183254321|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
91682036|NCT03118570|183254321|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||< 0.001
91682037|NCT03118570|183254321|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||< 0.001
91718667|NCT06494761|183329947|OTHER||Ratios of adjusted geometric means [%]|108.61|||||TWO_SIDED|90.0|98.79|119.41|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 14.3|The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||119.41|98.79|
91718668|NCT06494761|183329947|OTHER||Ratios of adjusted geometric means [%]|106.03|||||TWO_SIDED|90.0|95.49|117.73|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.9|The relative bioavailability of midazolam was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||117.73|95.49|
91718669|NCT06494761|183329948|OTHER||Ratios of adjusted geometric means [%]|108.13|||||TWO_SIDED|90.0|79.9|146.35|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 44.9|The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole with a single dose of zongertinib (Test Treatment 2) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||146.35|79.90|
91718670|NCT06494761|183329948|OTHER||Ratios of adjusted geometric means [%]|97.81|||||TWO_SIDED|90.0|75.01|127.53|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 38.5|The relative bioavailability of omeprazole was assessed by comparing Midazolam + Omeprazole after multiple doses of zongertinib (Test Treatment 4) to Midazolam + Omeprazole (Reference Treatment 2). The ratio of geometric means (Test/Reference) with 90% two-sided confidence intervals (CIs) was calculated. The log-transformed difference (log\[T\]-log\[R\]) was estimated using least squares means from ANOVA and then back-transformed to the original scale.||127.53|75.01|
91718671|NCT04865289|183329949|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.51|1.41||||||||1.41|0.51|
91718672|NCT04865289|183329950|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.48|1.21||||||||1.21|0.48|
91718673|NCT04865289|183329951|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.17||||0.5831415|TWO_SIDED|95.0|0.64|2.15|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||2.15|0.64|0.5831415
91526858|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.099|TWO_SIDED|95.0|-0.09|1.01||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.01|-0.09|0.099
91527615|NCT01976364|182930479|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.9|-0.9|
91682038|NCT03118570|183254321|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
91682039|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682040|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682041|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.080
91682042|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
91682043|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
91682044|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.035
91718674|NCT04865289|183329951|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6980186|TWO_SIDED|95.0|0.64|2.15|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||2.15|0.64|0.6980186
91718675|NCT04865289|183329952|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.52046|TWO_SIDED|95.0|0.57|1.8|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.80|0.57|0.52046
91718676|NCT04865289|183329953|OTHER||Difference in Percentage|-10.5||||0.8497|TWO_SIDED|95.0|-29.2|9.3|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||9.3|-29.2|0.8497
91682045|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.687||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.687
91682046|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.107||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.107
91682047|NCT03118570|183254323|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.128||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.128
91682048|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682049|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682050|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.088
91682051|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.184||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.184
91682052|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.144||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.144
91682053|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.028||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.028
91682054|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.694||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.694
91682055|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.143||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.143
91682056|NCT03118570|183254324|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.111||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.111
91682057|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682058|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91527616|NCT01976364|182930479|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.7|
91682059|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.026||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.026
91682060|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.007
91682061|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.004
91682062|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.085||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.085
91682063|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.040
91682064|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.061||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.061
91682065|NCT03118570|183254325|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.189||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.189
91682066|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682067|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
91682068|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.035
91682069|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
91682070|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
91682071|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.088
91682072|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.016||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.016
91682073|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.068
91682074|NCT03118570|183254326|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.16||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.160
91682075|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.065||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.065
91682076|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.405||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.405
91682077|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.966||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.966
91682078|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.003
91682079|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.229||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.229
91682080|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.807||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.807
91682081|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.042||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.042
91682082|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.283
91682083|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.536||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.536
91682084|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.765||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.765
91682085|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.247||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.247
91682086|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.050
91682087|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.037
91682088|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.174||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.174
91682089|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.558||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.558
91682090|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.02||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.020
91682091|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.346||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.346
91682092|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.387||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.387
91682093|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.093||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.093
91682094|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.156||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.156
91682095|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
91682096|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.92||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.920
91682097|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.040
91682098|NCT03118570|183254327|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.643||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.643
91682099|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.285||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.285
91682100|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.544||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.544
91682101|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
91682102|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.179||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.179
91682103|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.513||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.513
91527617|NCT01976364|182930480|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.3|
91682104|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.849||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.849
91682105|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.037
91682106|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.88||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.880
91718677|NCT04865289|183329954|OTHER||Difference in Percentage|-9.1||||0.8522|TWO_SIDED|95.0|-25.5|8.0|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||8.0|-25.5|0.8522
91718678|NCT04865289|183329955|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-2.14||||0.6138|TWO_SIDED|95.0|-10.54|6.27|||cLDA model|||||6.27|-10.54|0.6138
91718679|NCT04865289|183329956|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-0.73||||0.8398|TWO_SIDED|95.0|-7.93|6.46|||cLDA model|||||6.46|-7.93|0.8398
91718680|NCT03104374|183329961|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|32.8|||<|0.0001|TWO_SIDED|95.0|24.0|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||41.6|24.0|<0.0001
91718681|NCT03104374|183329961|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.7|||<|0.0001|TWO_SIDED|95.0|31.1|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|31.1|<0.0001
91718682|NCT03104374|183329962|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.12|-0.30|<0.0001
91718683|NCT03104374|183329962|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.40|<0.0001
91718684|NCT03104374|183329963|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|27.6|||<|0.0001|TWO_SIDED|95.0|19.2|36.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||36.1|19.2|<0.0001
91718685|NCT03104374|183329963|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.0|||<|0.0001|TWO_SIDED|95.0|22.3|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.8|22.3|<0.0001
91718686|NCT03104374|183329964|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.3|||<|0.0001|TWO_SIDED|95.0|25.6|46.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||46.9|25.6|<0.0001
91718687|NCT03104374|183329964|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|40.5|||<|0.0001|TWO_SIDED|95.0|29.9|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||51.0|29.9|<0.0001
91718688|NCT03104374|183329965|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.52|||<|0.0001|TWO_SIDED|95.0|2.07|4.98|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.98|2.07|<0.0001
91487326|NCT00717093|182847171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0919|TWO_SIDED|95.0|0.94|2.13||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.13|0.94|0.0919
91487327|NCT00418015|182847187|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||Log rank test||||0.54
91487328|NCT00418015|182847188|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Log Rank|||||||0.15
91487329|NCT00418015|182847189|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared, Corrected|||||||0.06
91487330|NCT00418015|182847190|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared, Corrected|||||||0.02
91487331|NCT00418015|182847191|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
91718689|NCT03104374|183329965|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.44|||<|0.0001|TWO_SIDED|95.0|3.99|6.88|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.88|3.99|<0.0001
91718690|NCT03104374|183329966|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.7|||<|0.0001|TWO_SIDED|95.0|2.0|5.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.4|2.0|<0.0001
91718691|NCT03104374|183329966|SUPERIORITY||LS Mean Difference|4.8|||<|0.0001|TWO_SIDED|95.0|3.1|6.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.||6.4|3.1|<0.0001
91718692|NCT03104374|183329967|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|22.3|||<|0.0001|TWO_SIDED|95.0|16.0|28.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||28.6|16.0|<0.0001
91718693|NCT03104374|183329967|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|26.1|||<|0.0001|TWO_SIDED|95.0|19.7|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||32.5|19.7|<0.0001
91718694|NCT03104374|183329968|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-27.4|-18.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-18.4|-27.4|<0.0001
91718695|NCT03104374|183329968|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.7|-23.8|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.8|-32.7|<0.0001
91718696|NCT03104374|183329969|SUPERIORITY||Response Rate Difference|27.0|||<|0.0001|TWO_SIDED|95.0|20.1|33.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.9|20.1|<0.0001
91718697|NCT03104374|183329969|SUPERIORITY||Response Rate Difference|32.9|||<|0.0001|TWO_SIDED|95.0|25.9|39.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.9|25.9|<0.0001
91718698|NCT03104374|183329970|SUPERIORITY||Response Rate Difference|8.1|||<|0.0001|TWO_SIDED|95.0|4.2|11.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||11.9|4.2|<0.0001
91718699|NCT03104374|183329970|SUPERIORITY||Response Rate Difference|16.0|||<|0.0001|TWO_SIDED|95.0|11.0|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.0|<0.0001
91718700|NCT03104374|183329971|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|14.3|29.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.4|14.3|<0.0001
91487332|NCT00418015|182847191|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
91487333|NCT02903355|182847198|SUPERIORITY|||||||0.4385|||||||Fisher Exact|||||||.4385
91487334|NCT02903355|182847199|SUPERIORITY|||||||0.5562|||||||Fisher Exact|||||||.5562
91487335|NCT02903355|182847200|SUPERIORITY|||||||0.5441|||||||Fisher Exact|||||||.5441
91487336|NCT02903355|182847201|SUPERIORITY|||||||0.3666|||||||Fisher Exact|||||||.3666
91487337|NCT02903355|182847202|SUPERIORITY|||||||0.4446|||||||Fisher Exact|||||||.4446
91487338|NCT02903355|182847203|SUPERIORITY|||||||0.5431|||||||Fisher Exact|||||||.5431
91487339|NCT02903355|182847204|SUPERIORITY|||||||0.7409|||||||Fisher Exact|||||||.7409
91487340|NCT02903355|182847205|SUPERIORITY|||||||0.1597|||||||Fisher Exact|||||||.1597
91487341|NCT02903355|182847206|SUPERIORITY|||||||0.2784|||||||t-test, 1 sided|||||||.2784
91682107|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.153||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.153
91682108|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.073||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.073
91682109|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.007
91682110|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.791||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.791
91682111|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.01||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.010
91682112|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.553||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.553
91682113|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.652||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.652
91682114|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
91682115|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.482
91682116|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.685||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.685
91682117|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.002
91682118|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.672||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.672
91682119|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.377||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.377
91682120|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.015
91682121|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.086
91682122|NCT03118570|183254328|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.712||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.712
91682123|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.045||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.045
91682124|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.101||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.101
91682125|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.482
91487342|NCT02903355|182847207|SUPERIORITY|||||||0.2303|||||||Fisher Exact|||||||.2303
91487343|NCT01314703|182847230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.85|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.66|3.02|||ANOVA||ChloraPrep 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.02|2.66|
91682126|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.011
91682127|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.508||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.508
91682128|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.563
91682129|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.917||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.917
91682130|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.789||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.789
91682131|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.262
91682132|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.426||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.426
91682133|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.871||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.871
91682134|NCT03118570|183254330|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.113||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.113
91682135|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
91682136|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
91682137|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.984||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||0.984
91682138|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||< 0.001
91682139|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
91526859|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.92||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.92|-0.18|0.186
91682140|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.857||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.857
91682141|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.001
91682142|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.079||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.079
91682143|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.912||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.912
91682144|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.054||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.054
91682145|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.95||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.950
91682146|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.555||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.555
91682147|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.221||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.221
91682148|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.393||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.393
91682149|NCT03118570|183254331|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.385
91682150|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
91682151|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
91682152|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
91682153|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.003
91718701|NCT03104374|183329971|SUPERIORITY||Response Rate Difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.1|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||30.2|15.1|<0.0001
91718702|NCT04609514|183330043|SUPERIORITY||Median Difference (Final Values)|10.95||||0.51|TWO_SIDED||||||Wilcoxon Rank Sum Test|||||||0.51
91682154|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
91682155|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.006
91682156|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.519||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.519
91718703|NCT04609514|183330044|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank Sum Test|||||||<0.001
91526860|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.684|TWO_SIDED|95.0|-0.35|0.54||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.54|-0.35|0.684
91682157|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.226||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.226
91682158|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.190
91682159|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.388||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.388
91718704|NCT04609514|183330049|SUPERIORITY|||||||0.39||||||A robust Yuen's test was conducted with an apriori threshold of 0.05 for statistical significance. No covariates were introduced in the model.|Robust Yuen's test|||||||0.39
91718705|NCT04609514|183330050|SUPERIORITY|||||||0.4|||||||Robust Yuen's test|||||||0.40
91718706|NCT04609514|183330051|SUPERIORITY|||||||0.478|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.478
91718707|NCT04609514|183330052|SUPERIORITY|||||||0.51|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.51
91682160|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.109
91718708|NCT04609514|183330054|SUPERIORITY||Odds Ratio (OR)|1.185||||0.8392|TWO_SIDED|95.0|0.23|6.119|||Regression, Logistic|||||6.119|0.23|0.8392
91526861|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.452|TWO_SIDED|95.0|-0.34|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.34|0.452
91682161|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.204
91682162|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.119||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.119
91682163|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.925||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.925
91682164|NCT03118570|183254332|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.204
91682165|NCT03118570|183254333|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.588||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.588
91682166|NCT03118570|183254333|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.697||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.697
91682167|NCT03118570|183254333|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.283
91682168|NCT03118570|183254333|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.354||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.354
91682169|NCT03118570|183254333|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.430
91682170|NCT03118570|183254333|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.091||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.091
91682171|NCT03118570|183254334|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.527||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.527
91682172|NCT03118570|183254334|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.738||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.738
91682173|NCT03118570|183254334|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.465||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.465
91682174|NCT03118570|183254334|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.068
91682175|NCT03118570|183254334|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.328||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.328
91682176|NCT03118570|183254334|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.277||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.277
91682177|NCT03118570|183254335|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.092||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.092
91682178|NCT03118570|183254335|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.31||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.310
91718709|NCT04609514|183330055|SUPERIORITY|||||||1|||||||Pearson's Chi-squared test|Pearson's Chi-squared test with Yates' continuity correction.||||||1.00
91682179|NCT03118570|183254335|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.304||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.304
91682180|NCT03118570|183254335|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.155||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.155
91682181|NCT03118570|183254335|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.392||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.392
91682182|NCT03118570|183254335|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.464||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.464
91682183|NCT03118570|183254336|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.15||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.150
91682184|NCT03118570|183254336|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.468||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.468
91682185|NCT03118570|183254336|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.8||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.800
91682186|NCT03118570|183254336|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.563
91682187|NCT03118570|183254336|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.839||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.839
91682188|NCT03118570|183254336|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.186||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.186
91682189|NCT03118570|183254337|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.278||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.278
91682190|NCT03118570|183254337|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.292||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.292
91682191|NCT03118570|183254337|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.115||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.115
91682192|NCT03118570|183254337|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.356||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.356
91682193|NCT03118570|183254337|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.205||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.205
91682194|NCT03118570|183254337|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.078
91682195|NCT03118570|183254338|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.037
91682196|NCT03118570|183254338|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.342||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.342
91682197|NCT03118570|183254338|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.515||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.515
91487344|NCT01314703|182847230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.038|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.74|4.33|||ANOVA||ChloraPrep 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||4.33|3.74|
91487345|NCT01314703|182847230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.36|2.7|||ANOVA||70%Isopropyl Alcohol 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||2.70|2.36|
91487346|NCT01314703|182847230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.53|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.24|3.82|||ANOVA||70% Isopropyl Alcohol 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.82|3.24|
91487347|NCT04195906|182847251|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.328||0.877|TWO_SIDED|96.0|-2.46|3.0||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline BWAT-CUA score and visit by randomized treatment interaction.|MMRM|MMRM=Mixed model for repeated measures Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||3.00|-2.46|0.877
91682198|NCT03118570|183254338|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.786||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.786
91682199|NCT03118570|183254338|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.212||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.212
91682200|NCT03118570|183254338|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.655||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.655
91682201|NCT01672970|183254356|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical analysis at Month 3||||0.000
91682202|NCT01672970|183254356|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
91682203|NCT01672970|183254357|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.001
91682204|NCT01672970|183254357|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.005
91682205|NCT01672970|183254358|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
91682206|NCT01672970|183254358|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
91682207|NCT01672970|183254359|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
91682208|NCT01672970|183254359|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.001
91682209|NCT01672970|183254362|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
91682210|NCT01672970|183254362|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
91682211|NCT01672970|183254363|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
91682212|NCT01672970|183254363|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
91682213|NCT01672970|183254368|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
91682214|NCT01672970|183254368|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
91682215|NCT01672970|183254369|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
91682216|NCT01672970|183254369|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
91682217|NCT01672970|183254370|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
91682218|NCT01672970|183254370|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
91682219|NCT01672970|183254371|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
91682220|NCT01672970|183254371|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
91682221|NCT01672970|183254372|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
91682222|NCT01672970|183254372|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
91682223|NCT01672970|183254373|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
91682224|NCT01672970|183254373|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
91682225|NCT04430855|183254374|SUPERIORITY||Response Rate Difference|13.3||||0.018|TWO_SIDED|95.0|-0.6|27.2|||Chi-squared||Response rate difference compared to historical placebo = upadacitinib 30 mg - historical placebo|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved HiSCR response to that of a prespecified, single historical placebo rate (25%). The historical placebo rate of 25% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||27.2|-0.6|0.018
91718710|NCT00885118|183330057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42828.482|STANDARD_ERROR_OF_MEAN|6487.174|<|0.0001|TWO_SIDED|95.0|29936.586|55720.378|||ANCOVA|The baseline value was included as a continuous covariate.||Difference calculated as empa 1mg minus placebo||55720.378|29936.586|<0.0001
91718711|NCT00885118|183330057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80964.677|STANDARD_ERROR_OF_MEAN|6303.82|<|0.0001|TWO_SIDED|95.0|68437.16|93492.194|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||93492.194|68437.160|<0.0001
91718712|NCT00885118|183330057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88589.764|STANDARD_ERROR_OF_MEAN|6544.604|<|0.0001|TWO_SIDED|95.0|75583.738|101595.79|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||101595.790|75583.738|<0.0001
91718713|NCT00885118|183330057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85620.348|STANDARD_ERROR_OF_MEAN|6610.091|<|0.0001|TWO_SIDED|95.0|72484.181|98756.515|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||98756.515|72484.181|<0.0001
91718714|NCT00885118|183330058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_ERROR_OF_MEAN|4.155||0.003|TWO_SIDED|95.0|-20.936|-4.424|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-4.424|-20.936|0.0030
91718715|NCT00885118|183330058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.92|STANDARD_ERROR_OF_MEAN|4.025|<|0.0001|TWO_SIDED|95.0|-27.919|-11.921|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.921|-27.919|<0.0001
91718716|NCT00885118|183330058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.208|STANDARD_ERROR_OF_MEAN|4.168|<|0.0001|TWO_SIDED|95.0|-34.49|-17.925|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-17.925|-34.490|<0.0001
91718717|NCT00885118|183330058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.235|STANDARD_ERROR_OF_MEAN|4.202|<|0.0001|TWO_SIDED|95.0|-35.586|-18.884|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-18.884|-35.586|<0.0001
91718718|NCT00885118|183330059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.883|STANDARD_ERROR_OF_MEAN|5.861||0.003|TWO_SIDED|95.0|-29.529|-6.236|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-6.236|-29.529|0.0030
91718719|NCT00885118|183330059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.487|STANDARD_ERROR_OF_MEAN|5.445|<|0.0001|TWO_SIDED|95.0|-33.308|-11.665|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.665|-33.308|<0.0001
91718720|NCT00885118|183330059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.265|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-37.762|-14.768|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-14.768|-37.762|<0.0001
91718721|NCT00885118|183330059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.34|STANDARD_ERROR_OF_MEAN|5.699|<|0.0001|TWO_SIDED|95.0|-39.665|-17.015|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-17.015|-39.665|<0.0001
91718722|NCT00885118|183330060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|STANDARD_ERROR_OF_MEAN|0.13||0.0705|TWO_SIDED|95.0|-0.498|-0.02|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.020|-0.498|0.0705
91718723|NCT00885118|183330060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.125||0.0203|TWO_SIDED|95.0|-0.545|-0.047|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-0.047|-0.545|0.0203
91718724|NCT00885118|183330060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.429|STANDARD_ERROR_OF_MEAN|0.13||0.0014|TWO_SIDED|95.0|-0.687|-0.17|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.170|-0.687|0.0014
91527618|NCT01976364|182930480|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.6|
91718725|NCT00885118|183330060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.131||0.0033|TWO_SIDED|95.0|-0.654|-0.135|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.135|-0.654|0.0033
91718726|NCT00885118|183330061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.527|STANDARD_ERROR_OF_MEAN|17.755||0.4823|TWO_SIDED|95.0|-22.757|47.811|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||47.811|-22.757|0.4823
91718727|NCT00885118|183330061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.984|STANDARD_ERROR_OF_MEAN|17.313||0.7305|TWO_SIDED|95.0|-28.422|40.39|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||40.390|-28.422|0.7305
91718728|NCT00885118|183330061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.858|STANDARD_ERROR_OF_MEAN|17.903||0.3213|TWO_SIDED|95.0|-53.438|17.721|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||17.721|-53.438|0.3213
91718729|NCT00885118|183330061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.838|STANDARD_ERROR_OF_MEAN|18.13||0.2768|TWO_SIDED|95.0|-55.869|16.192|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||16.192|-55.869|0.2768
91718730|NCT00885118|183330062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.192|STANDARD_ERROR_OF_MEAN|0.728|<|0.0001|TWO_SIDED|95.0|-5.653|-2.731|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-2.731|-5.653|<0.0001
91718731|NCT00885118|183330062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.609|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001||95.0|-6.126|-3.091|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-3.091|-6.126|<0.0001
91718732|NCT00885118|183330062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.036|STANDARD_ERROR_OF_MEAN|0.762|<|0.0001|TWO_SIDED|95.0|-5.565|-2.508|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-2.508|-5.565|<0.0001
91682226|NCT04430855|183254374|SUPERIORITY||Adjusted Response Rate Difference|9.2||||0.142|TWO_SIDED|95.0|-7.6|25.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%.||25.9|-7.6|0.142
91682227|NCT04430855|183254374|SUPERIORITY||Adjusted Response Rate Difference|14.7||||0.087|TWO_SIDED|95.0|-6.6|36.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||36.0|-6.6|0.087
91682228|NCT04430855|183254375|SUPERIORITY||Response Rate Difference|13.9||||0.028|TWO_SIDED|95.0|-2.5|30.3|||Chi-squared||Response rate difference compared to historical placebo (upadacitinib 30 mg - historical placebo)|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved NRS30 response to that of a prespecified, single historical placebo rate (22.5%). The historical placebo rate of 22.5% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||30.3|-2.5|0.028
91682229|NCT04430855|183254375|SUPERIORITY||Adjusted Response Rate Difference|4.5||||0.323|TWO_SIDED|95.0|-14.6|23.5||Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Cochran-Mantel-Haenszel||Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo NRS30 data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic NRS30 was 31.3%.||23.5|-14.6|0.323
91682230|NCT04430855|183254375|SUPERIORITY||Adjusted Response Rate Difference|2.2||||0.421|TWO_SIDED|95.0|-19.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||24.0|-19.6|0.421
91682231|NCT03801382|183254376|EQUIVALENCE|Validity and test-retest reliability were explored|Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED||||||t-test, 2 sided||||Validity and test-retest reliability were explored|||>.05
91682232|NCT00390221|183254384|SUPERIORITY_OR_OTHER||Rate Ratio|0.461|||<|0.0001|TWO_SIDED|95.0|0.318|0.668||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.668|0.318|<0.0001
91682233|NCT00390221|183254384|SUPERIORITY_OR_OTHER||Rate Ratio|0.503||||0.0002|TWO_SIDED|95.0|0.352|0.721||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.721|0.352|0.0002
91682234|NCT00390221|183254385|SUPERIORITY_OR_OTHER||Percent Reduction|78.44|||<|0.0001|TWO_SIDED|95.0|65.97|86.35|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||86.35|65.97|<0.0001
91682235|NCT00390221|183254385|SUPERIORITY_OR_OTHER||Percent Reduction|69.47|||<|0.0001|TWO_SIDED|95.0|52.4|80.41|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||80.41|52.40|<0.0001
91682236|NCT00390221|183254386|SUPERIORITY_OR_OTHER||Percent Reduction|78.73|||<|0.0001|TWO_SIDED|95.0|71.33|84.22|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||84.22|71.33|<0.0001
91682237|NCT00390221|183254386|SUPERIORITY_OR_OTHER||Percent Reduction|70.23|||<|0.0001|TWO_SIDED|95.0|59.94|77.88|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||77.88|59.94|<0.0001
91718733|NCT00885118|183330062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.887|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001|TWO_SIDED|95.0|-7.048|-2.726|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-2.726|-7.048|<0.0001
91718734|NCT00885118|183330063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.414||0.2498|TWO_SIDED|95.0|-1.302|0.343|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||0.343|-1.302|0.2498
91682238|NCT00390221|183254387|SUPERIORITY_OR_OTHER||Hazard Ratio|0.49||||0.0003|TWO_SIDED|95.0|0.33|0.72||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.72|0.33|0.0003
91682239|NCT00390221|183254387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.67||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.67|0.30|<0.0001
91682240|NCT00390221|183254388|SUPERIORITY_OR_OTHER||Relative Mean Change|-1.93||||0.1284|TWO_SIDED|95.0|-4.42|0.56||Analysis of variance for difference between treatment groups, controlling for baseline score.|Analysis of Variance|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.56|-4.42|0.1284
91682241|NCT00390221|183254388|SUPERIORITY_OR_OTHER||Relative Mean Change|-4.27||||0.0008|TWO_SIDED|95.0|-6.76|-1.78|||Analysis of Variance|Analysis of variance for difference between treatment groups, controlling for baseline score.||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||-1.78|-6.76|0.0008
91682242|NCT00918138|183254439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|7.01||0.1278|TWO_SIDED|95.0|-24.8|3.2||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|With at least 36 participants per treatment group (72 total), there is 90% power to detect a difference of 18 mg/dL between the two treatment groups. Assuming approximately 20% of participants will discontinue without any valid post-randomization assessment at Week 4, a total of 90 participants (45 participants per treatment group) needed to be randomized.||3.2|-24.8|0.1278
91682243|NCT00918138|183254440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|STANDARD_ERROR_OF_MEAN|11.8|||TWO_SIDED|95.0|-54.6|-7.7||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg.|||-7.7|-54.6|
91682244|NCT00918138|183254441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|7.18|||TWO_SIDED|95.0|-20.0|8.5||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model.|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|||8.5|-20.0|
91682245|NCT02885181|183254470|SUPERIORITY||Least Squares (LS) Means of Differences|0.01||||0.978|TWO_SIDED|95.0||0.76|||Cochran-Mantel-Haenszel|||||0.76|- 0.74|0.978
91682246|NCT02885181|183254470|SUPERIORITY||LS Means of Differences|0.4||||0.3|TWO_SIDED|95.0||1.16|||Cochran-Mantel-Haenszel|||||1.16|- 0.36|0.300
91682247|NCT02885181|183254470|SUPERIORITY||LS Means of Differences|0.0||||0.002|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||- 0.43|- 1.92|0.002
91718735|NCT00885118|183330063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.379|STANDARD_ERROR_OF_MEAN|0.408||0.3544|TWO_SIDED|95.0|-1.189|0.43|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||0.430|-1.189|0.3544
91682248|NCT02885181|183254471|SUPERIORITY||Difference in Response Rates|-5.9||||0.66|TWO_SIDED|95.0|-36.0|24.0|||Cochran-Mantel-Haenszel|||||24.0|-36.0|0.660
91682249|NCT02885181|183254471|SUPERIORITY||Difference in Response Rates|-15.9||||0.277|TWO_SIDED|95.0|-44.7|13.8|||Cochran-Mantel-Haenszel|||||13.8|-44.7|0.277
91682250|NCT02885181|183254471|SUPERIORITY||Difference in Response Rates|40.0||||0.009|TWO_SIDED|95.0|10.7|65.6|||Cochran-Mantel-Haenszel|||||65.6|10.7|0.009
91682251|NCT02885181|183254472|SUPERIORITY||Difference in Response Rates|-2.7||||0.853|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.853
91682252|NCT02885181|183254472|SUPERIORITY||Difference in Response Rates|-2.7||||0.852|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.852
91487348|NCT04195906|182847252|SUPERIORITY||Least Squares Mean Difference|11.49|STANDARD_ERROR_OF_MEAN|7.93||0.146|TWO_SIDED|96.0|-4.8|27.78||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||27.78|-4.80|0.146
91718736|NCT00885118|183330063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343|STANDARD_ERROR_OF_MEAN|0.416||0.0018|TWO_SIDED|95.0|-2.171|-0.516|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.516|-2.171|0.0018
91718737|NCT00885118|183330063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.257|STANDARD_ERROR_OF_MEAN|0.421||0.0037|TWO_SIDED|95.0|-2.094|-0.419|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.419|-2.094|0.0037
91718738|NCT00885118|183330064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-95.414|STANDARD_ERROR_OF_MEAN|15.388|<|0.0001|TWO_SIDED|95.0|-125.995|-64.833|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-64.833|-125.995|<0.0001
91718739|NCT00885118|183330064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.48|STANDARD_ERROR_OF_MEAN|14.67|<|0.0001|TWO_SIDED|95.0|-138.633|-80.327|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-80.327|-138.633|<0.0001
91718740|NCT00885118|183330064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.336|STANDARD_ERROR_OF_MEAN|15.354|<|0.0001|TWO_SIDED|95.0|-161.848|-100.824|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-100.824|-161.848|<0.0001
91718741|NCT00885118|183330064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-136.341|STANDARD_ERROR_OF_MEAN|15.357|<|0.0001|TWO_SIDED|95.0|-166.86|-105.823|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-105.823|-166.860|<0.0001
91718742|NCT00885118|183330065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.668|STANDARD_ERROR_OF_MEAN|13.152||0.0883|TWO_SIDED|95.0|-3.47|48.805|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||48.805|-3.470|0.0883
91526862|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.479|TWO_SIDED|95.0|-0.35|0.75||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.75|-0.35|0.479
91718743|NCT00885118|183330065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.576|STANDARD_ERROR_OF_MEAN|12.941||0.0203|TWO_SIDED|95.0|4.859|56.293|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||56.293|4.859|0.0203
91718744|NCT00885118|183330065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.974|STANDARD_ERROR_OF_MEAN|13.289||0.6541|TWO_SIDED|95.0|-20.434|32.382|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||32.382|-20.434|0.6541
91718745|NCT00885118|183330065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.015|STANDARD_ERROR_OF_MEAN|13.612||0.4206|TWO_SIDED|95.0|-16.036|38.066|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||38.066|-16.036|0.4206
91718746|NCT00885118|183330066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.869|STANDARD_ERROR_OF_MEAN|4.066||0.0318|TWO_SIDED|95.0|-16.949|-0.789|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.789|-16.949|0.0318
91718747|NCT00885118|183330066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.344|STANDARD_ERROR_OF_MEAN|3.966||0.0005|TWO_SIDED|95.0|-22.225|-6.462|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-6.462|-22.225|0.0005
91718748|NCT00885118|183330066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.642|STANDARD_ERROR_OF_MEAN|4.131||0.0003|TWO_SIDED|95.0|-23.853|-7.432|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-7.432|-23.853|0.0003
91718749|NCT00885118|183330066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.118|STANDARD_ERROR_OF_MEAN|4.137||0.0164|TWO_SIDED|95.0|-18.339|-1.897|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-1.897|-18.339|0.0164
91718750|NCT01265498|183330109|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.9||||0.0002|TWO_SIDED|95.0|1.3|2.8|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status.|obeticholic acid vs placebo|||2.8|1.3|0.0002
91718751|NCT01265498|183330110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.08|TWO_SIDED|95.0|0.9|2.6|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.6|0.9|0.08
91718752|NCT01265498|183330111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8||||0.004|TWO_SIDED|95.0|1.1|2.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.7|1.1|0.004
91718753|NCT01265498|183330112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.01|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.6|0.01
91487349|NCT04195906|182847253|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.237||0.706|TWO_SIDED|96.0|-0.38|0.56||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||0.56|-0.38|0.706
91526863|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.01||||0.955|TWO_SIDED|95.0|-0.44|0.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.46|-0.44|0.955
91718754|NCT01265498|183330113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-1.3|<0.0001
91527619|NCT01976364|182930480|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.4|
91682253|NCT02885181|183254472|SUPERIORITY||Difference in Response Rates|24.9||||0.092|TWO_SIDED|95.0|-6.6|51.5|||Cochran-Mantel-Haenszel|||||51.5|-6.6|0.092
91682254|NCT02885181|183254473|SUPERIORITY||Difference in Response Rates|-8.6||||0.36|TWO_SIDED|95.0|-37.9|22.5|||Cochran-Mantel-Haenszel|||||22.5|-37.9|0.360
91682255|NCT02885181|183254473|SUPERIORITY||Difference in Response Rates|1.4||||0.896|TWO_SIDED|95.0|-28.0|31.7|||Cochran-Mantel-Haenszel|||||31.7|-28.0|0.896
91682256|NCT02885181|183254473|SUPERIORITY||Difference in Response Rates|24.5||||0.072|TWO_SIDED|95.0|-6.6|50.1|||Cochran-Mantel-Haenszel|||||50.1|-6.6|0.072
91682257|NCT02885181|183254474|SUPERIORITY||LS Means of Differences|-0.12||||0.528|TWO_SIDED|95.0|-0.49|0.25|||Cochran-Mantel-Haenszel|||||0.25|-0.49|0.528
91682258|NCT02885181|183254474|SUPERIORITY||LS Means of Differences|0.2||||0.293|TWO_SIDED|95.0|-0.17|0.57|||Cochran-Mantel-Haenszel|||||0.57|-0.17|0.293
91682259|NCT02885181|183254474|SUPERIORITY||LS Means of Differences|-0.33||||0.072|TWO_SIDED|95.0|-0.7|0.03|||Cochran-Mantel-Haenszel|||||0.03|-0.70|0.072
91682260|NCT04562155|183254521|SUPERIORITY||||||=|0.0345||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=30) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0345
91682261|NCT04562155|183254521|SUPERIORITY||||||=|0.0376||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=50) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0376
91682262|NCT04562155|183254521|SUPERIORITY||||||=|0.0319||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=30, h=3) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0319
91682263|NCT04562155|183254521|SUPERIORITY||||||=|0.0603||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=60, h=5) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0603
91682264|NCT04005352|183254546|SUPERIORITY||||||<|0.0001|ONE_SIDED|||||with significance level of 0.025|Wilcoxon (Mann-Whitney)|||||||<0.0001
91682265|NCT04005352|183254547|NON_INFERIORITY|4 letter margin (1-sided)|Difference|0.1|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-1.3|1.5|||ANOVA|||||1.5|-1.3|<0.0001
91682266|NCT04005352|183254548|SUPERIORITY||||||<|0.0001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91682267|NCT04005352|183254549|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91718755|NCT01265498|183330114|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.03|TWO_SIDED|95.0|1.0|2.1|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.1|1.0|0.03
91682268|NCT04005352|183254550|SUPERIORITY|Week 14|Odds Ratio (OR)|1.6||||0.051|TWO_SIDED|95.0|0.9|2.7|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||2.7|0.9|0.0510
91682269|NCT04005352|183254550|SUPERIORITY|Week 16|Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||3.9|1.7|<0.0001
91682270|NCT04005352|183254553|SUPERIORITY||Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.84||0.8137|TWO_SIDED|95.0|-1.9|1.5||p-value for treatment difference|ANOVA|||||1.5|-1.9|0.8137
91682271|NCT04005352|183254554|SUPERIORITY|Week 32|Odds Ratio (OR)|1.0||||0.4106|TWO_SIDED|95.0|0.7|1.3|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.3|0.7|0.4106
91682272|NCT04005352|183254554|SUPERIORITY|Week 64|Odds Ratio (OR)|1.0||||0.4667|TWO_SIDED|95.0|0.7|1.4|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.4|0.7|0.4667
91682273|NCT04005352|183254555|SUPERIORITY|Week 32|Odds Ratio (OR)|1.1||||0.2397|TWO_SIDED|95.0|0.8|1.7|||likelihood ratio test|assessed at the 0.025 significance level||||1.7|0.8|0.2397
91682274|NCT04005352|183254555|SUPERIORITY|Week 64|Odds Ratio (OR)|1.2||||0.115|TWO_SIDED|95.0|0.9|1.8|||likelihood ratio test|assessed at the 0.025 significance level||||1.8|0.9|0.1150
91682275|NCT04005352|183254556|SUPERIORITY|Weeks 28 and 32|Difference|-26.9|STANDARD_ERROR_OF_MEAN|9.87||0.0066|TWO_SIDED|95.0|-46.3|-7.5|||ANOVA|||||-7.5|-46.3|0.0066
91682276|NCT04005352|183254556|SUPERIORITY|Weeks 60 and 64|Difference|-15.4|STANDARD_ERROR_OF_MEAN|11.26||0.1714|TWO_SIDED|95.0|-37.6|6.7|||ANOVA|||||6.7|-37.6|0.1714
91682277|NCT04005352|183254559|SUPERIORITY|Week 32|LS Mean Difference|0.37||||0.193|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.193
91682278|NCT04005352|183254559|SUPERIORITY|Week 64|LS Mean Difference|-2.0||||0.052|TWO_SIDED|95.0|-3.9|0.0|||ANCOVA|||||0.0|-3.9|0.052
91682279|NCT04005352|183254560|SUPERIORITY|Week 32|LS Mean Difference|2.16||||0.081|TWO_SIDED|95.0|-0.3|4.6|||ANCOVA|||||4.6|-0.3|0.081
91682280|NCT04005352|183254560|SUPERIORITY|Week 64|LS Mean Difference|-0.7||||0.59|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.590
91682281|NCT04005352|183254561|SUPERIORITY|Week 32|LS Mean Difference|0.77||||0.558|TWO_SIDED|95.0|-1.8|3.4|||ANCOVA|||||3.4|-1.8|0.558
91682282|NCT04005352|183254561|SUPERIORITY|Week 64|LS Mean Difference|-1.9||||0.138|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|||||0.6|-4.5|0.138
91682283|NCT04005352|183254562|SUPERIORITY|Week 32|LS Mean Difference|1.6||||0.287|TWO_SIDED|95.0|-1.4|4.6|||ANCOVA|||||4.6|-1.4|0.287
91682284|NCT04005352|183254562|SUPERIORITY|Week 64|LS Mean Difference|-3.0||||0.07|TWO_SIDED|95.0|-6.2|0.2|||ANCOVA|||||0.2|-6.2|0.070
91682285|NCT04005352|183254563|SUPERIORITY|Week 32|LS Mean Difference|-0.71||||0.602|TWO_SIDED|95.0|-3.4|2.0|||ANCOVA|||||2.0|-3.4|0.602
91682286|NCT04005352|183254563|SUPERIORITY|Week 64|LS Mean Difference|-2.5||||0.086|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.086
91682287|NCT04005352|183254564|SUPERIORITY|Week 32|LS Mean Difference|1.55||||0.174|TWO_SIDED|95.0|-0.7|3.8|||ANCOVA|||||3.8|-0.7|0.174
91682288|NCT04005352|183254564|SUPERIORITY|Week 64|LS Mean Difference|-1.5||||0.21|TWO_SIDED|95.0|-3.8|0.8|||ANCOVA|||||0.8|-3.8|0.210
91682289|NCT04005352|183254565|SUPERIORITY|Week 32|LS Mean Difference|-0.96||||0.499|TWO_SIDED|95.0|-3.8|1.8|||ANCOVA|||||1.8|-3.8|0.499
91682290|NCT04005352|183254565|SUPERIORITY|Week 64|LS Mean Difference|-2.3||||0.147|TWO_SIDED|95.0|-5.4|0.8|||ANCOVA|||||0.8|-5.4|0.147
91682291|NCT04005352|183254566|SUPERIORITY|Week 32|LS Mean Difference|0.88||||0.643|TWO_SIDED|95.0|-2.8|4.6|||ANCOVA|||||4.6|-2.8|0.643
91682292|NCT04005352|183254566|SUPERIORITY|Week 64|LS Mean Difference|-1.3||||0.507|TWO_SIDED|95.0|-5.0|2.5|||ANCOVA|||||2.5|-5.0|0.507
91718756|NCT01265498|183330115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.03|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.0|-0.5|0.03
91682293|NCT04005352|183254567|SUPERIORITY|Week 32|LS Mean Difference|0.49||||0.7|TWO_SIDED|95.0|-2.0|3.0|||ANCOVA|||||3.0|-2.0|0.700
91682294|NCT04005352|183254567|SUPERIORITY|Week 64|LS Mean Difference|-2.9||||0.07|TWO_SIDED|95.0|-6.0|0.2|||ANCOVA|||||0.2|-6.0|0.070
91682295|NCT04005352|183254568|SUPERIORITY|Week 32|LS Mean Difference|0.73||||0.741|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||||5.1|-3.6|0.741
91682296|NCT04005352|183254568|SUPERIORITY|Week 64|LS Mean Difference|-1.7||||0.494|TWO_SIDED|95.0|-6.6|3.2|||ANCOVA|||||3.2|-6.6|0.494
91682297|NCT04005352|183254569|SUPERIORITY|Week 32|LS Mean Difference|1.76||||0.054|TWO_SIDED|95.0|0.0|3.5|||ANCOVA|||||3.5|-0.0|0.054
91682298|NCT04005352|183254569|SUPERIORITY|Week 64|LS Mean Difference|-1.1||||0.331|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.331
91682299|NCT04005352|183254570|SUPERIORITY|Week 32|LS Mean Difference|1.24||||0.394|TWO_SIDED|95.0|-1.6|4.1|||ANCOVA|||||4.1|-1.6|0.394
91682300|NCT04005352|183254570|SUPERIORITY|Week 64|LS Mean Difference|-0.5||||0.728|TWO_SIDED|95.0|-3.6|2.5|||ANCOVA|||||2.5|-3.6|0.728
91682301|NCT00176423|183254580|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91682302|NCT00176423|183254581|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91682303|NCT00176423|183254582|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91682304|NCT00176423|183254583|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91682305|NCT01755767|183254589|SUPERIORITY|||||||0.8006|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.8006
91682306|NCT01755767|183254589|SUPERIORITY||Hazard Ratio (HR)|0.9682||||0.8061|TWO_SIDED|95.0|0.7483|1.2529|||Regression, Cox|Stratified Cox Regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2529|0.7483|0.8061
91682307|NCT01755767|183254591|SUPERIORITY|||||||0.7509|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.7509
91682308|NCT01755767|183254591|SUPERIORITY||Hazard Ratio (HR)|0.9557||||0.716|TWO_SIDED|95.0|0.7487|1.22|||Regression, Cox|Stratified Cox regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2200|0.7487|0.7160
91682309|NCT00998309|183254603|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders."||||=0.001
91682310|NCT00998309|183254604|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the participatns of responders."||||=1.000
91682311|NCT00998309|183254605|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders."||||<0.001
91682312|NCT00998309|183254606|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders."||||=0.556
91682313|NCT00998309|183254607|SUPERIORITY_OR_OTHER||||||=|0.074|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders."||||=0.074
91682314|NCT00998309|183254608|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders."||||=1.000
91682315|NCT00998309|183254609|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders."||||=1.000
91682316|NCT00998309|183254610|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications  in the participatns of responders."||||=1.000
91682317|NCT00998309|183254611|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders."||||=1.000
91526864|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.465|TWO_SIDED|95.0|-0.36|0.79||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.79|-0.36|0.465
91682318|NCT00998309|183254612|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders."||||=0.470
91682319|NCT00998309|183254613|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders."||||=1.000
91682320|NCT00998309|183254616|SUPERIORITY_OR_OTHER||||||=|0.657|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.657
91682321|NCT00998309|183254617|SUPERIORITY_OR_OTHER||||||=|0.145|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years or \>=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.145
91682322|NCT00998309|183254618|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.005
91682323|NCT00998309|183254619|SUPERIORITY_OR_OTHER||||||=|0.213|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.213
91682324|NCT00998309|183254620|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=1.000
91682325|NCT00998309|183254621|SUPERIORITY_OR_OTHER||||||=|0.116|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.116
91682326|NCT00998309|183254622|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||<0.001
91682327|NCT00998309|183254623|SUPERIORITY_OR_OTHER||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.645
91682328|NCT00998309|183254624|SUPERIORITY_OR_OTHER||||||=|0.679|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.679
91682329|NCT00998309|183254625|SUPERIORITY_OR_OTHER||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.234
91682330|NCT00998309|183254626|SUPERIORITY_OR_OTHER||||||=|0.039|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.039
91682331|NCT00998309|183254627|SUPERIORITY_OR_OTHER||||||=|0.605|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female."||||=0.605
91682332|NCT04154631|183254694|SUPERIORITY||Time by treatment interaction coeff.|-10.91|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.||||<0.001
91682333|NCT04154631|183254694|SUPERIORITY||Coefficient of indirect effect|0.17||||0.95|TWO_SIDED|95.0|-4.62|4.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||4.95|-4.62|0.95
91718757|NCT01265498|183330116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.3|1.2|0.001
91682334|NCT04154631|183254694|SUPERIORITY||Coefficient of indirect effect|0.09||||0.95|TWO_SIDED|95.0|-2.39|2.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.56|-2.39|0.95
91682335|NCT04154631|183254694|SUPERIORITY||Coefficient of indirect effect|-0.16||||0.88|TWO_SIDED|95.0|-2.31|1.98|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.98|-2.31|0.88
91682336|NCT04154631|183254694|SUPERIORITY||Coefficient of indirect effect|-0.13||||0.88|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.88
91718758|NCT01265498|183330117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-0.6|0.0004
91718759|NCT01265498|183330118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6||||0.006|TWO_SIDED|95.0|1.1|2.2|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.2|1.1|0.006
91682337|NCT04154631|183254694|SUPERIORITY||Coefficient of indirect effect|-0.5||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
91682338|NCT04154631|183254694|SUPERIORITY||Coefficient of indirect effect|-0.26||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
91682339|NCT04154631|183254695|SUPERIORITY||time by treatment interaction coeff.|-0.03||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Acceptability Intervention Measure (AIM) from baseline (post-training) to post-treatment.||||0.77
91682340|NCT04154631|183254696|SUPERIORITY||Time by treatment interaction coeff.|-9.52|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep-related impairment from pre to post.||||<0.001
91682341|NCT04154631|183254696|SUPERIORITY||Coefficient of indirect effect|0.26||||0.92|TWO_SIDED|95.0|-5.04|5.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||5.56|-5.04|0.92
91682342|NCT04154631|183254696|SUPERIORITY||Coefficient of indirect effect|0.1||||0.92|TWO_SIDED|95.0|-2.04|2.24|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.24|-2.04|0.92
91682343|NCT04154631|183254696|SUPERIORITY||Coefficient of indirect effect|-0.39||||0.78|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.78
91682344|NCT04154631|183254696|SUPERIORITY||Coefficient of indirect effect|-0.3||||0.78|TWO_SIDED|95.0|-2.35|1.75|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.75|-2.35|0.78
91682345|NCT04154631|183254696|SUPERIORITY||Coefficient of indirect effect|-0.43||||0.84|TWO_SIDED|95.0|-4.66|3.8|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||3.80|-4.66|0.84
91682346|NCT04154631|183254696|SUPERIORITY||Coefficient of indirect effect|-0.18||||0.84|TWO_SIDED|95.0|-1.94|1.58|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.58|-1.94|0.84
91682347|NCT04154631|183254697|SUPERIORITY||Time by treatment interaction coeff.|1.63|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.||||<0.001
91682348|NCT04154631|183254698|SUPERIORITY||Time by treatment interaction coeff.|-5.12|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.||||<0.001
91682349|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|-3.12|||<|0.001|TWO_SIDED|95.0|-4.58|-1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-1.66|-4.58|<0.001
91682350|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|-3.81|||<|0.001|TWO_SIDED|95.0|-5.41|-2.22|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at post||-2.22|-5.41|<0.001
91682351|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|0.07||||0.94|TWO_SIDED|95.0|-1.78|1.92|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.92|-1.78|0.94
91682352|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|0.05||||0.94|TWO_SIDED|95.0|-1.16|1.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.25|-1.16|0.94
91682353|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|0.03||||0.85|TWO_SIDED|95.0|-0.3|0.37|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.37|-0.30|0.85
91718760|NCT01265498|183330119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.5|0.0006
91718761|NCT01265498|183330120|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.9|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||1.7|0.6|0.90
91718762|NCT01265498|183330121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.59|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-0.1|0.59
91718763|NCT01265498|183330122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-11.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-11|-28|<0.0001
91718764|NCT01265498|183330123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.0001|TWO_SIDED|95.0|-18.0|-6.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-6|-18|0.0001
91718765|NCT01265498|183330124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|||<|0.0001|TWO_SIDED|95.0|13.0|24.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||24|13|<0.0001
91718766|NCT01265498|183330125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-14.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-14|-35|<0.0001
91718767|NCT01265498|183330126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.002|TWO_SIDED|95.0|-2.4|-0.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-2.4|0.002
91718768|NCT01265498|183330127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.0009|TWO_SIDED|95.0|0.16|0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.60|0.16|0.0009
91718769|NCT01265498|183330128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.01|TWO_SIDED|95.0|-0.1|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.10|0.01
91718770|NCT01265498|183330129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.65|0.26|<0.0001
91718771|NCT01265498|183330130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.30|-0.35|0.88
91718772|NCT01265498|183330131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.72|TWO_SIDED|95.0|-1.8|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.8|0.72
91718773|NCT01265498|183330132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.01|-0.01|0.71
91718774|NCT01265498|183330133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.002|TWO_SIDED|95.0|-1.8|-0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.4|-1.8|0.002
91718775|NCT01265498|183330134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.4|-0.2|0.40
91718776|NCT01265498|183330135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.001|TWO_SIDED|95.0|7.0|26.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||26|7|0.001
91718777|NCT01265498|183330136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.03|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-1.4|0.03
91526865|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.992|TWO_SIDED|95.0|-0.57|0.58||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.58|-0.57|0.992
91718778|NCT01265498|183330137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.04|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.04|0.00|0.04
91718779|NCT01265498|183330138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.53|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.05|-0.03|0.53
91718780|NCT01265498|183330139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.03|TWO_SIDED|95.0|0.2|5.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||5.0|0.2|0.03
91718781|NCT01265498|183330140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.05|TWO_SIDED|95.0|0.0|29.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||29|0|0.05
91718782|NCT01265498|183330141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.13|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-1.2|0.13
91718783|NCT01265498|183330142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.31|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.6|-0.5|0.31
91718784|NCT01265498|183330143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.1|-0.6|0.16
91718785|NCT01265498|183330144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.002|TWO_SIDED|95.0|-0.04|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.04|0.002
91718786|NCT01265498|183330145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.26|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.8|-0.2|0.26
91718787|NCT01265498|183330146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.02|TWO_SIDED|95.0|6.0|69.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||69|6|0.02
91718788|NCT01265498|183330147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.01|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||23|3|0.01
91718789|NCT01265498|183330148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71|TWO_SIDED|95.0|-1.7|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.7|0.71
91718790|NCT01265498|183330149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.6|-3.7|0.008
91718791|NCT01265498|183330150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.01|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-1.3|0.01
91718792|NCT01265498|183330151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.5|-2.2|0.70
91718793|NCT01265498|183330152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.57|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.02|-0.01|0.57
91487350|NCT04195906|182847254|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|2.63||0.995|TWO_SIDED|96.0|-5.27|5.24||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||5.24|-5.27|0.995
91718794|NCT01265498|183330153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.05|TWO_SIDED|95.0|-7.0|0.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0|-7|0.05
91718795|NCT01265498|183330154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1|-4|0.23
91718796|NCT01265498|183330155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.22|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||3|-1|0.22
91718797|NCT01265498|183330156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.65|TWO_SIDED|95.0|-3.0|2.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2|-3|0.65
91718798|NCT01373164|183330196|SUPERIORITY|The planned primary analysis for this study utilized a Bayesian exponential-likelihood model, incorporating historical overall survival (OS) data from 2 studies (Oettle et al. 2005; Saif et al. 2009). The primary analysis was performed using strong borrowing from the historical data. The model was estimated to borrow approximately 37 events from the historical studies.|Hazard Ratio (HR)|0.794|||||TWO_SIDED|95.0|0.59|1.085|||Bayesian Analysis|Primary comparison was to be considered successful if there was at least 0.85 posterior probability that the hazard ratio (HR) for OS of LY+Gem is \<1.|This is a Credible Interval estimated from the Bayesian analysis.|||1.085|0.590|
91718799|NCT03055013|183330214|SUPERIORITY||Cox Proportional Hazard|0.95||||0.34|TWO_SIDED|95.0|0.74|1.22|||Log Rank|stratified logrank test (one-sided)|hazard ratio : arm A vs. arm B|||1.22|0.74|0.34
91718800|NCT02765035|183330250|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||C-Leg 3 vs. NMPK (Baseline)||||0.01
91718801|NCT02765035|183330250|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||C-Leg 4 vs. NMPK (Baseline)||||0.04
91718802|NCT01259245|183330274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017||||0.252|TWO_SIDED|95.0|-0.046|0.012||Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education|ANCOVA|||||0.012|-0.046|0.252
91718803|NCT01259245|183330275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_DEVIATION|0.442||0.984|TWO_SIDED|95.0|-0.438|0.447|||ANCOVA|Adjusted for baseline values, age, sex, education, BMI and smoking||power0.80 for a medium effect size at 5% level of significance||0.447|-0.438|0.984
91718804|NCT01259245|183330276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372|STANDARD_DEVIATION|4.433||0.869|TWO_SIDED|95.0|-4.061|4.805|||ANCOVA|adjusted for baseline values, age, sex, education, BMI and education||power of 0.80 for a medium effect size at 5% level of significance||4.805|-4.061|0.869
91487351|NCT04195906|182847255|SUPERIORITY||Odds Ratio, log|1.54|STANDARD_ERROR_OF_MEAN|0.498||0.384|TWO_SIDED|95.0|0.58|4.09||This model includes the stratification factor sodium thiosulfate use at baseline and the treatment as covariates|Regression, Logistic|As there is only a measure post-baseline, a logistic regression model was run instead of a generalized estimating equations model.|The odds ratio displayed is the odds ratio of having an improved result of SNF472 versus Placebo. The results 'Worsened', 'Equal', and 'Missing' are combined in one category and it is the reference for the odds ratio calculation.|||4.09|0.58|0.384
91682354|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|-0.23||||0.7|TWO_SIDED|95.0|-1.41|0.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.95|-1.41|0.70
91682355|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.23|0.92
91682356|NCT04154631|183254698|SUPERIORITY||Coefficient of indirect effect|-0.07||||0.82|TWO_SIDED|95.0|-0.68|0.54|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.54|-0.68|0.82
91682357|NCT04154631|183254699|SUPERIORITY||Time by treatment interaction coeff.|-6.72|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.||||<0.001
91682358|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|-1.86||||0.08|TWO_SIDED|95.0|-3.93|-0.21|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.21|-3.93|0.08
91682359|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|-2.51||||0.02|TWO_SIDED|95.0|-4.58|-0.44|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.||-0.44|-4.58|0.02
91682360|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|0.05||||0.97|TWO_SIDED|95.0|-1.99|2.08|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.08|-1.99|0.97
91682361|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|0.004||||0.97|TWO_SIDED|95.0|-0.18|0.19|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||0.19|-0.18|0.97
91682362|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|0.02||||0.9|TWO_SIDED|95.0|-0.27|0.3|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.30|-0.27|0.90
91682363|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|0.01||||0.94|TWO_SIDED|95.0|-0.19|0.2|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.20|-0.19|0.94
91682364|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|-0.19||||0.8|TWO_SIDED|95.0|-1.67|1.28|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.28|-1.67|0.80
91682365|NCT04154631|183254699|SUPERIORITY||Coefficient of indirect effect|-0.04||||0.77|TWO_SIDED|95.0|-0.33|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.33|0.77
91682366|NCT04154631|183254700|SUPERIORITY||time by treatment interaction coeff.|-0.01||||0.94|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Intervention Appropriateness Measure (IAM) from baseline (post-training) to post-treatment.||||0.94
91682367|NCT04154631|183254701|SUPERIORITY||Time by treatment interaction coeff.|-0.11||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Feasibility of Intervention Measure (FIM) from baseline (post-training) to post-treatment.||||0.34
91682368|NCT05187013|183254723|SUPERIORITY||Mean Difference (Net)|-7.16|STANDARD_ERROR_OF_MEAN|2.72||0.006|TWO_SIDED|95.0|-12.59|-1.73|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final SBP, i.e., Final SBP - Baseline SBP \>= 0 Alternative Hypothesis: Final SBP - Baseline SBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -7.16 and 21.40, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 83.16%||-1.73|-12.59|0.006
91682369|NCT05187013|183254723|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|1.32||0.056|TWO_SIDED|95.0|-4.79|0.49|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final DBP, i.e., Final DBP - Baseline DBP \>= 0 Alternative Hypothesis: Final DBP - Baseline DBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -2.15 and 10.49, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 51.48%||0.49|-4.79|0.056
91682370|NCT05187013|183254723|EQUIVALENCE|The margin was considered to be 0.|Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|4.13||0.87|TWO_SIDED|95.0|-8.76|7.42|||ANCOVA|Adjusted for baseline SBP and follow-up time|The parameter was defined as the change in SBP for the general health education arm - the change in SBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in SBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||7.42|-8.76|0.87
91682371|NCT05187013|183254723|EQUIVALENCE|The margin was taken to be 0|Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.04||0.63|TWO_SIDED|95.0|-3.02|4.98|||ANCOVA|Adjusted for baseline DBP and follow-up time|The parameter was defined as the change in DBP for the general health education arm - the change in DBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in DBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||4.98|-3.02|0.63
91682372|NCT05187013|183254724|EQUIVALENCE|The margin is taken to be 0|Odds Ratio, log|0.89|STANDARD_ERROR_OF_MEAN|0.61||0.14|TWO_SIDED|95.0|-0.26|2.29|||Regression, Logistic|A mixed effect model with study arm as a fixed effect and subject-specific random effect.|For OR: the general education arm was taken as the baseline (denominator)|Null hypothesis: There is no difference in medicine adherence between the two groups||2.29|-0.26|0.14
91682373|NCT05187013|183254725|EQUIVALENCE|The margin was taken to be 0.|Odds Ratio, log|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.32|TWO_SIDED|95.0|-0.58|0.19|||Regression, Logistic|Binomial regression for appointment attended/appointment scheduled.|The baseline (denominator) was taken to be the general education arm.|Null hypothesis: No difference in appointment adherence between the study arms||0.19|-0.58|0.32
91682374|NCT01568320|183254734|SUPERIORITY_OR_OTHER_LEGACY||Freedom from Major adverse events (%)|71.6|||||TWO_SIDED|95.0|59.0|82.0|||||Clopper-Pearson (Exact) Method|||82|59|
91682375|NCT01568320|183254735|SUPERIORITY_OR_OTHER_LEGACY||Survival rate (%)|95.5|||||TWO_SIDED|95.0|87.0|99.0|||||Clopper-Pearson (Exact) Method|||99|87|
91682376|NCT03233230|183254736|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1746|TWO_SIDED|95.0|0.84|2.61|||Regression, Logistic|||||2.61|0.84|0.1746
91682377|NCT03233230|183254736|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8283|TWO_SIDED|95.0|0.61|1.87|||Regression, Logistic|||||1.87|0.61|0.8283
91682378|NCT03233230|183254736|SUPERIORITY||Odds Ratio (OR)|1.55||||0.1298|TWO_SIDED|95.0|0.88|2.74|||Regression, Logistic|||||2.74|0.88|0.1298
91682379|NCT03233230|183254737|SUPERIORITY||Response rate difference|0.13||||0.0077|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0077
91682380|NCT03233230|183254737|SUPERIORITY||Response rate difference|0.17||||0.0013|TWO_SIDED|95.0|0.07|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.07|0.0013
91682381|NCT03233230|183254737|SUPERIORITY||Response rate difference|0.13||||0.008|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0080
91682382|NCT03233230|183254738|SUPERIORITY||Response rate difference|0.09||||0.0056|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0056
91682383|NCT03233230|183254738|SUPERIORITY||Response rate difference|0.09||||0.005|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0050
91682384|NCT03233230|183254738|SUPERIORITY||Response rate difference|0.09||||0.0053|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0053
91682385|NCT03233230|183254739|SUPERIORITY||Response rate difference|0.09||||0.1419|TWO_SIDED|95.0|-0.03|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.03|0.1419
91682386|NCT03233230|183254739|SUPERIORITY||Response rate difference|0.07||||0.2202|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2202
91682387|NCT03233230|183254739|SUPERIORITY||Response rate difference|0.07||||0.2328|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2328
91682388|NCT03233230|183254740|SUPERIORITY||Response rate difference|0.06||||0.1232|TWO_SIDED|95.0|-0.02|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.02|0.1232
91682389|NCT03233230|183254740|SUPERIORITY||Response rate difference|0.05||||0.1725|TWO_SIDED|95.0|-0.03|0.14|||Cochran-Mantel-Haenszel|||||0.14|-0.03|0.1725
91682390|NCT03233230|183254740|SUPERIORITY||Response rate difference|0.05||||0.1795|TWO_SIDED|95.0|-0.03|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.03|0.1795
91682391|NCT03233230|183254748|SUPERIORITY||Response rate difference|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
91682392|NCT03233230|183254748|SUPERIORITY||Response rate difference|0.01|||||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
91682393|NCT03233230|183254748|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
91682394|NCT03233230|183254749|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.02|0.09||||||||0.09|-0.02|
91682395|NCT03233230|183254749|SUPERIORITY||Response rate difference|0.05|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|-0.00|
91682396|NCT03233230|183254749|SUPERIORITY||Response rate difference|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||||0.08|-0.03|
91682397|NCT03233230|183254750|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
91682398|NCT03233230|183254750|SUPERIORITY||Response rate difference|0.04|||||TWO_SIDED|95.0|0.0|0.1||||||||0.10|0.00|
91682399|NCT03233230|183254750|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
91682400|NCT03233230|183254751|SUPERIORITY||Response rate difference|0.11|||||TWO_SIDED|95.0|-0.03|0.24||||||||0.24|-0.03|
91682401|NCT03233230|183254751|SUPERIORITY||Response rate difference|0.12|||||TWO_SIDED|95.0|-0.02|0.25||||||||0.25|-0.02|
91682402|NCT03233230|183254751|SUPERIORITY||Response rate difference|0.18|||||TWO_SIDED|95.0|0.05|0.31||||||||0.31|0.05|
91682403|NCT04159935|183254773|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
91682404|NCT04159935|183254774|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||||||0.057
91682405|NCT04159935|183254775|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91682406|NCT04159935|183254777|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
91682407|NCT04159935|183254778|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
91682408|NCT04159935|183254779|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
91682409|NCT04159935|183254780|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91682410|NCT04159935|183254781|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
91682411|NCT04159935|183254783|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
91682412|NCT04159935|183254784|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.700
91682413|NCT04159935|183254785|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
91526866|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.376|TWO_SIDED|95.0|-0.26|0.68||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.68|-0.26|0.376
91682414|NCT02472223|183254800|SUPERIORITY||Median Difference (Final Values)|90.0||||0.02|TWO_SIDED|||||p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
91682415|NCT00206323|183254825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0259|||||||t-test, 2 sided|||"Primary variable change of TTS/YGTSS at the BSL to Day 70. Changes of YGTSS compared using analysis of covariance with score at day 1 as a covariate. Groups compared for incidence of AE's and of AESI based on Fisher's Exact Test. All tests were two-sided at the 5% level of significance.~The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)"||||0.0259
91682416|NCT03657342|183254870|SUPERIORITY||LS Mean Difference|-0.095||||0.731|TWO_SIDED|95.0|-0.405|0.214||1-sided p value.|Mixed Models Analysis|||at V9.||0.214|-0.405|0.7310
91682417|NCT03657342|183254871|SUPERIORITY||least suare mean difference|-0.064||||0.8041|TWO_SIDED|95.0|-0.212|0.084||1-sided p value|Mixed Models Analysis|||Estimates were from a Linear Mixed Model on the response variable change from baseline in FEV1/FVC with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1/FVC, the interactions of time splines with baseline FEV1/FVC, region (North America versus all other countries together), underlying indication for lung transplant (COPD versus all others), use of azithromycin at randomization, and time as random effect.||0.084|-0.212|0.8041
91682418|NCT03657342|183254872|SUPERIORITY||adjusted hazard ratio|2.601||||0.1559|TWO_SIDED|95.0|0.408|16.585||1-sided p value. Adjusted Hazard Ratio calculated using Cox proportional hazards model with covariates of Treatment, Baseline FEV1, with Efron's method of tie handling.|Regression, Cox|||||16.585|0.408|0.1559
91682419|NCT01753336|183254878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|STANDARD_DEVIATION|8.94|||TWO_SIDED|95.0|-9.79|-6.28||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.||-6.28|-9.79|
91682420|NCT01753336|183254878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|11.68|||TWO_SIDED|95.0|-7.36|-2.68||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.||-2.68|-7.36|
91682421|NCT01753336|183254878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|STANDARD_DEVIATION|7.29|||TWO_SIDED|95.0|-7.42|-4.47||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.||-4.47|-7.42|
91682422|NCT01753336|183254878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|7.49|||TWO_SIDED|95.0|-3.37|-0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.||-0.27|-3.37|
91682423|NCT01753336|183254878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_DEVIATION|9.03|||TWO_SIDED|95.0|-5.99|-2.2||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-2.20|-5.99|
91682424|NCT01753336|183254878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|9.42|||TWO_SIDED|95.0|-3.11|0.81||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.81|-3.11|
91682425|NCT01753336|183254879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|9.74|||TWO_SIDED|95.0|-13.38|-9.56||||||Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.||-9.56|-13.38|
91682426|NCT01753336|183254879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|STANDARD_DEVIATION|10.89|||TWO_SIDED|95.0|-11.08|-6.71||||||Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.||-6.71|-11.08|
91682427|NCT01753336|183254879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|STANDARD_DEVIATION|11.43|||TWO_SIDED|95.0|-16.74|-12.11||||||Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.||-12.11|-16.74|
91682428|NCT01753336|183254879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|STANDARD_DEVIATION|11.33|||TWO_SIDED|95.0|-12.92|-8.22||||||Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.||-8.22|-12.92|
91718805|NCT01259245|183330277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.295|STANDARD_DEVIATION|4.706||0.588|TWO_SIDED|95.0|-6.001|3.411|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium size effect at 5% level of significance||3.411|-6.001|0.588
91682429|NCT01753336|183254879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|STANDARD_DEVIATION|12.19|||TWO_SIDED|95.0|-17.18|-12.1||||||Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.||-12.10|-17.18|
91682430|NCT01753336|183254879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|STANDARD_DEVIATION|11.17|||TWO_SIDED|95.0|-14.02|-9.39||||||Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.||-9.39|-14.02|
91682431|NCT01753336|183254881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.95|||TWO_SIDED|95.0|-4.46|-2.52||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.52|-4.46|
91682432|NCT01753336|183254881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|5.24|||TWO_SIDED|95.0|-2.81|-0.7||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.70|-2.81|
91682433|NCT01753336|183254881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.77|||TWO_SIDED|95.0|-3.75|-2.23||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-2.23|-3.75|
91682434|NCT01753336|183254881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-1.33|0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.27|-1.33|
91682435|NCT01753336|183254881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_DEVIATION|4.32|||TWO_SIDED|95.0|-3.64|-1.83||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-1.83|-3.64|
91682436|NCT01753336|183254881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|4.77|||TWO_SIDED|95.0|-2.0|-0.02||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||-0.02|-2.00|
91682437|NCT01753336|183254882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-3.64|-2.12||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.12|-3.64|
91682438|NCT01753336|183254882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|4.82|||TWO_SIDED|95.0|-2.79|-0.86||||||Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.86|-2.79|
91682439|NCT01753336|183254882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.47|||TWO_SIDED|95.0|-2.44|-1.04||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-1.04|-2.44|
91682440|NCT01753336|183254882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-1.55|-0.12||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||-0.12|-1.55|
91682441|NCT01753336|183254882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|3.75|||TWO_SIDED|95.0|-1.45|0.12||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.12|-1.45|
91682442|NCT01753336|183254882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.73|||TWO_SIDED|95.0|-0.85|0.7||||||Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.70|-0.85|
91682443|NCT01753336|183254883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.74|||TWO_SIDED|95.0|-2.39|-0.92||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-0.92|-2.39|
91682444|NCT01753336|183254883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.88|||TWO_SIDED|95.0|-2.22|-0.66||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.66|-2.22|
91682445|NCT01753336|183254883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|3.12|||TWO_SIDED|95.0|-1.84|-0.58||||||Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-0.58|-1.84|
91526867|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.36||||0.229|TWO_SIDED|95.0|-0.22|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.22|0.229
91682446|NCT01753336|183254883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.04|||TWO_SIDED|95.0|-1.08|0.18||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.18|-1.08|
91682447|NCT01753336|183254883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-1.57|0.19||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.19|-1.57|
91682448|NCT01753336|183254883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.78|||TWO_SIDED|95.0|-0.85|0.73||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.73|-0.85|
91682449|NCT01770392|183254910|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|50.12|STANDARD_DEVIATION|12.7||1|TWO_SIDED|90.0|47.155|53.275||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)"|||53.275|47.155|1.0000
91682450|NCT01770392|183254911|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|59.76|STANDARD_DEVIATION|21.9||1|TWO_SIDED|90.0|53.829|66.348||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||66.348|53.829|1.0000
91682451|NCT01770392|183254912|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|49.98|STANDARD_DEVIATION|13.3||1|TWO_SIDED|90.0|46.886|53.286||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||53.286|46.886|1.0000
91682452|NCT04682730|183254921|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.18|TWO_SIDED|95.0|0.58|1.11|||Mixed Models Analysis|||||1.11|0.58|0.18
91682453|NCT04682730|183254923|OTHER|single intervention group across 16 clinics|mean total program costs in 2021 dollars|7845.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|6378.0|9312.0|||||An opportunity cost approach was used. Costs estimated: Develop workbook- guideline, EHR data analyses, survey, evidence review- \& print; facilitator training/delivery/program tailoring; staff time; implemented strategies; dental sealant placements.|Mean Total Program costs per clinic for the KPNW Dental system.||9312|6378|
91682454|NCT04682730|183254927|OTHER|single intervention group across 16 clinics|mean total costs/per clinic per sealant|1321.0|STANDARD_DEVIATION|1245.0|||TWO_SIDED|95.0|845.0|3208.0|||||Total cost per sealant calculated as quotient of total intervention costs ($125,521) \& total sealants placed (95), is = to mean cost/sealant across each clinic ($7845/5.938).|Mean Total Program costs per sealant per clinic for the KPNW Dental system.||3208|845|
91682455|NCT04682730|183254929|OTHER|descriptive analysis|percentage|100.0|||||TWO_SIDED||||||||||89/89 treatment plans completed by the end of the period.|||
91682456|NCT00620659|183254970|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.615
91682457|NCT00620659|183254971|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-4.11|||||TWO_SIDED|90.0|-5.92|-2.3||||||||-2.30|-5.92|
91682458|NCT00620659|183254972|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-3.8|||||TWO_SIDED|90.0|-5.23|-2.38||||||||-2.38|-5.23|
91682459|NCT00620659|183254973|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.079
91682460|NCT00620659|183254974|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.003
91682461|NCT02352779|183254975|OTHER||Mean Difference (Final Values)|0.6763|STANDARD_ERROR_OF_MEAN|0.4843||0.1666|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1666
91682462|NCT02352779|183254975|OTHER||Mean Difference (Final Values)|0.6936|STANDARD_ERROR_OF_MEAN|0.4567||0.1329|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1329
91682463|NCT02352779|183254975|OTHER||Mean Difference (Final Values)|0.0831|STANDARD_ERROR_OF_MEAN|3.8065||0.9826|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.9826
91682464|NCT02352779|183254975|OTHER||Mean Difference (Final Values)|2.9898|STANDARD_ERROR_OF_MEAN|3.5448||0.4016|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.4016
91682465|NCT01540773|183254985|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91682466|NCT01540773|183254986|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91682467|NCT03867097|183255007|SUPERIORITY||LS mean difference in change|-0.77|STANDARD_ERROR_OF_MEAN|4.047||0.8498|TWO_SIDED|95.0|-9.04|7.49|||ANCOVA||The Shapiro-Wilk normality test of residuals indicated that the data did not have a normal distribution (p-value 0.0108).|"Treatment comparison of change versus placebo. LS mean difference in change. When a subject had no RP attacks in the past 24 hours, the frequency was considered as zero for that day.~The LS means, SEs, CIs, and p-values came from an ANCOVA model with randomized treatment group and use of phosphodiesterase inhibitors at screening (yes, no) as factors and baseline as a covariate."||7.49|-9.04|0.8498
91682468|NCT03867097|183255007|SUPERIORITY||Median Difference (Final Values)|-0.24||||0.9729|TWO_SIDED|95.0|-9.97|9.32|||Wilcoxon (Mann-Whitney)|||"Change in the Weekly Frequency of Symptomatic Raynaud's Phenomenon Attacks From Baseline to the Double-Blind Endpoint Using Nonparametric Analysis - Modified Intent-to-Treat Population.~Treatment comparison of change versus placebo."||9.32|-9.97|0.9729
91682469|NCT01398943|183255010|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91682470|NCT01398943|183255010|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91682471|NCT01398943|183255011|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91682472|NCT01398943|183255011|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91682473|NCT00191113|183255054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001||95.0|0.7|1.1|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interaction terms removed when not significant.|"Effect direction is As-Randomized Humatrope minus As-Randomized Control"|This component of the primary analysis is inferential i.e. to ascertain definitively whether Humatrope treatment affects change in Height SDS (NCHS). Null hypothesis is no effect of Humatrope treatment.||1.1|0.7|<0.001
91682474|NCT00191113|183255055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001||95.0|0.9|1.2|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interactions terms removed when not significant.|"Effect direction is As-Treated Growth Hormone minus As-Treated No Growth Hormone"|Estimation analysis of the magnitude of effect of treatment with growth hormone upon Final Height. Null hypothesis is no effect of growth hormone upon attained height standard deviation score (National Center for Health Statistics).||1.2|0.9|<0.001
91682475|NCT00191113|183255056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.001||95.0|0.9|1.3|||ANCOVA|||||1.3|0.9|<0.001
91682476|NCT00191113|183255057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9|||<|0.001||95.0|5.7|8.1|||ANCOVA|||||8.1|5.7|<0.001
91682477|NCT00191113|183255058|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
91682478|NCT00191113|183255059|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
91682479|NCT00191113|183255060|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Fisher Exact|||||||0.073
91682480|NCT00191113|183255061|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||Comparison of proportion of patients with any category of hearing loss between As-Treated Growth Hormone group and As-Treated No Growth Hormone.||||>0.999
91682481|NCT00191113|183255062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.492||||0.419||95.0|-8.631|3.646|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||3.646|-8.631|0.419
91682482|NCT00191113|183255064|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||Fisher Exact|||||||0.545
91682483|NCT00191113|183255066|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
91682484|NCT00191113|183255068|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
91682485|NCT00191113|183255069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.945||95.0|-0.199|0.186|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||0.186|-0.199|0.945
91682486|NCT00191113|183255071|SUPERIORITY_OR_OTHER|||||||||95.0||||P-value cannot be computed since no patients had abnormal result in either comparison group.|Fisher Exact|||||||
91682487|NCT01555671|183255076|OTHER||Mean Difference (Net)|30.0||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.029
91682488|NCT00631657|183255079|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|48.7|||<|0.0001|TWO_SIDED|95.0|35.0|62.5|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.|||62.5|35.0|<0.0001
91682489|NCT00631657|183255082|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.9||||0.2145|TWO_SIDED|95.0|-12.6|2.8|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.|||2.8|-12.6|0.2145
91682490|NCT00631657|183255083|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.0|||<|0.0001|TWO_SIDED|95.0|-34.5|-15.4|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.|||-15.4|-34.5|<0.0001
91682491|NCT00806286|183255117|SUPERIORITY||Mean Difference (Final Values)|-23.2|||<|0.0001|TWO_SIDED|||||Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
91682492|NCT00806286|183255117|SUPERIORITY||Cox Proportional Hazard|1.579||||0.0499|TWO_SIDED|95.0|1.0|2.5|||Regression, Cox|||||2.5|1.0|0.0499
91682493|NCT00806286|183255118|SUPERIORITY|Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Mean Difference (Final Values)|-25.5|||<|0.0001|TWO_SIDED||||||Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
91682494|NCT04713553|183255140|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.13|0.91|
91682495|NCT04713553|183255140|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.04|0.83|
91682496|NCT04713553|183255140|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.92|||||TWO_SIDED|95.0|0.82|1.03|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.03|0.82|
91682497|NCT04713553|183255141|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.07|0.84|
91682498|NCT04713553|183255142|NON_INFERIORITY|Noninferiority of the 20 mcg dose to the corresponding 30 mcg dose was said to be achieved if the lower limit of the 2-sided 95% CI for the GMR is \>0.67.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||GMRs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group|||1.02|0.84|
91682499|NCT03151408|183255198|SUPERIORITY|||||||0.8275||||||P-value stratified by cytogenetic risk factor and ECOG performance status|Log Rank|||||||0.8275
91682500|NCT03151408|183255199|OTHER|||||||0.1244|||||||Cochran-Mantel-Haenszel|||||||0.1244
91682501|NCT03151408|183255200|OTHER|||||||0.143|||||||Cochran-Mantel-Haenszel|||||||0.1430
91526868|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.581|TWO_SIDED|95.0|-0.41|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.41|0.581
91682502|NCT03151408|183255201|SUPERIORITY|||||||0.9977|||||||Cochran-Mantel-Haenszel|||||||0.9977
91682503|NCT03151408|183255202|OTHER|||||||0.9959|||||||Cochran-Mantel-Haenszel|||||||0.9959
91682504|NCT03151408|183255203|OTHER|||||||0.3502|||||||Cochran-Mantel-Haenszel|||||||0.3502
91682505|NCT03151408|183255204|OTHER|||||||0.0502|||||||Log Rank|||||||0.0502
91682506|NCT03151408|183255206|OTHER|||||||0.4656|||||||Log Rank|||||||0.4656
91682507|NCT03151408|183255207|OTHER|||||||0.7063|||||||Log Rank|||||||0.7063
91682508|NCT03151408|183255208|OTHER|||||||0.0592|||||||Log Rank|||||||0.0592
91682509|NCT03151408|183255209|OTHER|||||||0.3835|||||||Log Rank|||||||0.3835
91682510|NCT03151408|183255210|OTHER|||||||0.7099|||||||Cochran-Mantel-Haenszel|||||||0.7099
91682511|NCT00265395|183255211|SUPERIORITY_OR_OTHER||SVR Rate Difference|-4.9||||0.6445||95.0|-20.4|10.6|||Asymptotic Z-test|||||10.6|-20.4|0.6445
91682512|NCT03400943|183255212|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.0001|TWO_SIDED|95.0|0.33|0.78|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 41 (Vilaprisan) / 20 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.78|0.33|<.0001
91682513|NCT02045147|183255232|OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|3.82||0.463|TWO_SIDED|95.0|-4.98|10.65|||t-test, 2 sided|||||10.65|-4.98|0.463
91682514|NCT02045147|183255232|OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.4||0.634|TWO_SIDED|95.0|-5.23|8.49|||t-test, 2 sided|||||8.49|-5.23|0.634
91682515|NCT02045147|183255232|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.15||0.259|TWO_SIDED|95.0|-3.74|13.32|||t-test, 2 sided|||||13.32|-3.74|0.259
91682516|NCT02045147|183255232|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED|95.0|-3.21|6.84|||t-test, 2 sided|||||6.84|-3.21|0.472
91682517|NCT02045147|183255233|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.15||0.532|TWO_SIDED|95.0|-8.5|4.5|||t-test, 2 sided|||||4.5|-8.5|0.532
91682518|NCT02045147|183255233|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0|-7.5|4.2|||t-test, 2 sided|||||4.2|-7.5|0.574
91682519|NCT02045147|183255233|OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.254|TWO_SIDED|95.0|-12.3|3.4|||t-test, 2 sided|||||3.4|-12.3|0.254
91682520|NCT02045147|183255233|OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.7||0.759|TWO_SIDED|95.0|-6.3|4.6|||t-test, 2 sided|||||4.6|-6.3|0.759
91682521|NCT02045147|183255234|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|3.6||0.153|TWO_SIDED|95.0|-2.1|12.7|||t-test, 2 sided|||||12.7|-2.1|0.153
91682522|NCT02045147|183255234|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|3.3||0.729|TWO_SIDED|95.0|-7.9|5.5|||t-test, 2 sided|||||5.5|-7.9|0.729
91682523|NCT02045147|183255234|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.886|TWO_SIDED|95.0|-6.6|7.6|||t-test, 2 sided|||||7.6|-6.6|0.886
91682524|NCT02045147|183255234|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.1||0.446|TWO_SIDED|95.0|-8.7|3.9|||t-test, 2 sided|||||3.9|-8.7|0.446
91682525|NCT02045147|183255235|OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.1||0.521|TWO_SIDED|95.0|-5.7|11.1|||t-test, 2 sided|||||11.1|-5.7|0.521
91682526|NCT02045147|183255235|OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.7||0.146|TWO_SIDED|95.0|-1.5|9.5|||t-test, 2 sided|||||9.5|-1.5|0.146
91682527|NCT02045147|183255235|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.3||0.926|TWO_SIDED|95.0|-8.5|9.3|||t-test, 2 sided|||||9.3|-8.5|0.926
91682528|NCT02045147|183255235|OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|2.4||0.526|TWO_SIDED|95.0|-6.4|3.3|||t-test, 2 sided|||||3.3|-6.4|0.526
91682529|NCT02045147|183255236|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|3.9||0.776|TWO_SIDED|95.0|-9.2|6.9|||t-test, 2 sided|||||6.9|-9.2|0.776
91682530|NCT02045147|183255236|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.135|TWO_SIDED|95.0|-1.6|11.7|||t-test, 2 sided|||||11.7|-1.6|0.135
91682531|NCT02045147|183255236|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.1||0.556|TWO_SIDED|95.0|-10.9|6.0|||t-test, 2 sided|||||6.0|-10.9|0.556
91682532|NCT02045147|183255236|OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|2.7||0.361|TWO_SIDED|95.0|-2.9|7.9|||t-test, 2 sided|||||7.9|-2.9|0.361
91682533|NCT02045147|183255237|OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.4||0.564|TWO_SIDED|95.0|-6.4|11.6|||t-test, 2 sided|||||11.6|-6.4|0.564
91682534|NCT02045147|183255237|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.1||0.307|TWO_SIDED|95.0|-3.0|9.3|||t-test, 2 sided|||||9.3|-3.0|0.307
91682535|NCT02045147|183255237|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.8||0.768|TWO_SIDED|95.0|-6.7|8.9|||t-test, 2 sided|||||8.9|-6.7|0.768
91682536|NCT02045147|183255237|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.785|TWO_SIDED|95.0|-4.2|5.5|||t-test, 2 sided|||||5.5|-4.2|0.785
91682537|NCT02045147|183255238|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.5||0.917|TWO_SIDED|95.0|-7.5|6.8|||t-test, 2 sided|||||6.8|-7.5|0.917
91682538|NCT02045147|183255238|OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|3.3||0.181|TWO_SIDED|95.0|-2.2|11.3|||t-test, 2 sided|||||11.3|-2.2|0.181
91682539|NCT02045147|183255238|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.6||0.772|TWO_SIDED|95.0|-6.3|8.3|||t-test, 2 sided|||||8.3|-6.3|0.772
91682540|NCT02045147|183255238|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.8||0.526|TWO_SIDED|95.0|-3.8|7.3|||t-test, 2 sided|||||7.3|-3.8|0.526
91682541|NCT02045147|183255239|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.42||0.872|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided|||||.9|-.8|0.872
91682542|NCT02045147|183255239|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.387|TWO_SIDED|95.0|-0.87|0.34|||t-test, 2 sided|||||.34|-.87|0.387
91682543|NCT02045147|183255239|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.916|TWO_SIDED|95.0|-0.37|0.81|||t-test, 2 sided|||||.81|-.37|0.916
91682544|NCT02045147|183255239|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.189|TWO_SIDED|95.0|-0.19|0.94|||t-test, 2 sided|||||.94|-.19|0.189
91682545|NCT02045147|183255240|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.627|TWO_SIDED|95.0|-0.21|0.13|||t-test, 2 sided|||||.13|-.21|0.627
91682546|NCT02045147|183255240|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.84|TWO_SIDED|95.0|-0.11|0.09|||t-test, 2 sided|||||.09|-.11|0.840
91682547|NCT02045147|183255240|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|-0.22|0.0|||t-test, 2 sided|||||-.00|-.22|0.049
91682548|NCT02045147|183255240|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.952|TWO_SIDED|95.0|-0.06|0.06|||t-test, 2 sided|||||.06|-.06|0.952
91682549|NCT02045147|183255241|OTHER||Mean Difference (Final Values)|6.9||||0.436|TWO_SIDED|95.0|-11.07|25.0|||t-test, 2 sided|||||25.00|-11.07|.436
91682550|NCT02045147|183255241|OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|6.71||0.088|TWO_SIDED|95.0|-25.24|1.8|||t-test, 2 sided|||||1.80|-25.24|.088
91682551|NCT02045147|183255241|OTHER||Median Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.45||0.169|TWO_SIDED|95.0|-25.86|4.77|||t-test, 2 sided|||||4.77|-25.86|0.169
91682552|NCT02045147|183255241|OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|4.52||0.416|TWO_SIDED|95.0|-12.79|5.37|||t-test, 2 sided|||||5.37|-12.79|0.416
91682553|NCT00049530|183255242|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||bionomial proportion test|||It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.||||<0.001
91682554|NCT06017479|183255260|OTHER|"Chi-square test as the study used chi-square analysis to compare the incidence of UTIs between the groups (p = 0.660) For this non-inferiority analysis, the study demonstrated that the odds ratio (OR) between the two groups was 0.8 (95% CI: 0.4-1.95), indicating no significant difference. Further details are provided in the study's discussion section."|Odds Ratio (OR)|0.8|STANDARD_DEVIATION|18.125||0.66|TWO_SIDED|95.0|0.4|1.95||The p-value was not adjusted for multiple comparisons as there were no multiple outcome measures being compared in this analysis. The significance threshold (alpha) was set at 0.05.|Chi-squared||"The standard deviations (SD) for the groups are as follows:~For the group receiving 3g fosfomycin: 19.08 For the group receiving 500mg levofloxacin: 17.17"|This randomized controlled trial compared the incidence of UTI between two groups: patients receiving a single dose of 500 mg levofloxacin and patients receiving a single dose of 3 g fosfomycin one hour before a urodynamic study. The null hypothesis is that there is no significant difference in UTI incidence between the two groups. The power calculation was based on a sample size of 126 patients.|A chi-square test was performed to compare the incidence of UTIs between the two groups: patients receiving a single dose of 500 mg levofloxacin and those receiving a single dose of 3 g fosfomycin, both administered one hour before the urodynamic study (UDS). The result showed no statistically significant difference between the two groups (p = 0.660). An odds ratio was also calculated (OR = 0.8, 95% CI: 0.4-1.95), indicating a slightly lower likelihood of UTI in the fosfomycin group, but the difference was not significant.|1.95|0.4|0.660
91682555|NCT00936897|183255261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.8|||ANCOVA||Denosumab - Ibandronate|||1.8|1.0|<0.0001
91682556|NCT00936897|183255262|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91682557|NCT00936897|183255263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||<|0.0001|TWO_SIDED|95.0|0.7|1.7|||ANCOVA||Denosumab - Ibandronate|||1.7|0.7|<0.0001
91682558|NCT00936897|183255264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.5|||ANCOVA||Denosumab - Ibandronate|||2.5|1.5|<0.0001
91682559|NCT04058067|183255270|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.013|TWO_SIDED|95.0|-3.7|1.1|||ANOVA|||||1.1|-3.7|0.013
91682560|NCT04058067|183255271|SUPERIORITY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.15||0.035|TWO_SIDED|95.0|-4.2|0.4|||ANOVA|||||0.4|-4.2|0.035
91682561|NCT04058067|183255273|SUPERIORITY||Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.0|0.8|||ANOVA|||||0.8|-3.0|
91682562|NCT04058067|183255274|SUPERIORITY||Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-4.0|0.2|||ANOVA|||||0.2|-4.0|
91682563|NCT04058067|183255275|SUPERIORITY||Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-4.3|0.2|||ANOVA|||||0.2|-4.3|
91682564|NCT04058067|183255278|SUPERIORITY||DIfference|-3.0|||||TWO_SIDED|95.0|-13.7|6.7|||Regression, Logistic|||Proportion of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.7|-13.7|
91682565|NCT04058067|183255278|SUPERIORITY||Difference|-2.6|||||TWO_SIDED|95.0|-14.7|9.4|||Regression, Logistic|||Proportion of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||9.4|-14.7|
91682566|NCT04058067|183255278|SUPERIORITY||Difference|-3.8|||||TWO_SIDED|95.0|-15.5|6.9|||Regression, Logistic|||Proportion of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.9|-15.5|
91682567|NCT04058067|183255282|SUPERIORITY||DIfference|0.1|||||TWO_SIDED|95.0|-4.2|4.4|||Regression, Logistic|||Proportion of subjects with ≥5 letters loss from baseline at Week 52||4.4|-4.2|
91682568|NCT04058067|183255282|SUPERIORITY||Difference|0.8|||||TWO_SIDED|95.0|-1.6|3.8|||Regression, Logistic|||Proportion of subjects with ≥10 letters loss from baseline at Week 52||3.8|-1.6|
91682569|NCT04058067|183255282|SUPERIORITY||Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.3|||Regression, Logistic|||Proportion of subjects with ≥15 letters loss from baseline at Week 52||2.3|-2.2|
91682570|NCT04058067|183255283|OTHER|Descriptive, Week 4|Difference - %|0.4|||||TWO_SIDED|95.0|-7.9|8.6|||Clopper-Pearson exact method|||Week 4||8.6|-7.9|
91682571|NCT04058067|183255283|OTHER|Descriptive, Week 6|Difference - %|-5.1|||||TWO_SIDED|95.0|-14.3|2.9|||Clopper-Pearson exact method|||Week 6||2.9|-14.3|
91682572|NCT04058067|183255283|OTHER|Descriptive, Week 8|Difference - %|-4.0||||||95.0|-13.3|4.4|||Clopper-Pearson exact method|||Week 8||4.4|-13.3|
91682573|NCT04058067|183255283|OTHER|Descriptive, Week 12|Difference - %|-7.0|||||TWO_SIDED|95.0|-16.4|2.3|||Clopper-Pearson exact method|||Week 12||2.3|-16.4|
91682574|NCT04058067|183255283|OTHER|Descriptive, Week 16|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.2|0.0|||Clopper-Pearson exact method|||Week 16||-0.0|-19.2|
91526869|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.19||||0.422|TWO_SIDED|95.0|-0.28|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.28|0.422
91682575|NCT04058067|183255283|OTHER|Descriptive, Week 18|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.0|0.0|||Clopper-Pearson exact method|||Week 18||-0.0|-19.0|
91682576|NCT04058067|183255283|OTHER|Descriptive, Week 20|Difference - %|-5.7|||||TWO_SIDED|95.0|-15.8|3.9|||Clopper-Pearson exact method|||Week 20||3.9|-15.8|
91682577|NCT04058067|183255283|OTHER|Descriptive, Week 24|Difference - %|-13.4|||||TWO_SIDED|95.0|-23.9|-3.1|||Clopper-Pearson exact method|||Week 24||-3.1|-23.9|
91682578|NCT04058067|183255283|OTHER|Descriptive, Week 28|Difference - %|-12.4|||||TWO_SIDED|95.0|-22.0|-2.1|||Clopper-Pearson exact method|||Week 28||-2.1|-22.0|
91682579|NCT04058067|183255283|OTHER|Descriptive, Week 32|Difference - %|-15.4|||||TWO_SIDED|95.0|-26.0|-4.8|||Clopper-Pearson exact method|||Week 32||-4.8|-26.0|
91682580|NCT04058067|183255283|OTHER|Descriptive, Week 36|Difference - %|-18.8|||||TWO_SIDED|95.0|-29.5|-8.9|||Clopper-Pearson exact method.|||Week 36||-8.9|-29.5|
91682581|NCT04058067|183255283|OTHER|Descriptive, Week 40|Difference - %|-18.4|||||TWO_SIDED|95.0|-28.7|-8.6|||Clopper-Pearson exact method|||Week 40||-8.6|-28.7|
91682582|NCT04058067|183255283|OTHER|Descriptive, Week 44|Difference - %|-14.9|||||TWO_SIDED|95.0|-25.6|-4.4|||Clopper-Pearson exact method|||Week 44||-4.4|-25.6|
91682583|NCT04058067|183255283|OTHER|Descriptive, Week 48|Difference - %|-13.3|||||TWO_SIDED|95.0|-23.6|-3.4|||Clopper-Pearson exact method|||Week 48||-3.4|-23.6|
91682584|NCT04058067|183255283|OTHER|Descriptive, Week 52|Difference - %|-12.6|||||TWO_SIDED|95.0|-23.5|-2.9|||Clopper-Pearson exact method|||Week 52||-2.9|-23.5|
91682585|NCT04058067|183255284|SUPERIORITY||Difference|-1.3|||||TWO_SIDED|95.0|-13.6|11.2|||Clopper-Pearson exact method|||||11.2|-13.6|
91682586|NCT04058067|183255286|SUPERIORITY||Difference|-10.2|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-37.3|17.0|||ANOVA|||||17.0|-37.3|
91682587|NCT04058067|183255287|SUPERIORITY||Difference|-2.5|STANDARD_ERROR_OF_MEAN|12.34|||TWO_SIDED|95.0|-26.8|21.9|||ANOVA|||||21.9|-26.8|
91682588|NCT04058067|183255288|SUPERIORITY||Difference|-8.5|STANDARD_ERROR_OF_MEAN|11.03|||TWO_SIDED|95.0|-30.3|13.2|||ANOVA|||||13.2|-30.3|
91682589|NCT04058067|183255289|SUPERIORITY||Difference - %|5.3|||||TWO_SIDED|95.0|-3.3|13.5|||Clopper-Pearson exact method|||Week 4||13.5|-3.3|
91682590|NCT04058067|183255289|SUPERIORITY||Difference - %|10.8|||||TWO_SIDED|95.0|1.4|20.6|||Clopper-Pearson exact method|||Week 6||20.6|1.4|
91682591|NCT04058067|183255289|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|3.9|25.3|||Clopper-Pearson exact method|||Week 8||25.3|3.9|
91682592|NCT04058067|183255289|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|2.8|24.9|||Clopper-Pearson exact method||Proportion estimates (%) = 39.3|Week 12||24.9|2.8|
91682593|NCT04058067|183255289|SUPERIORITY||Difference - %|16.8||||||95.0|5.1|28.6|||Clopper-Pearson exact method|||Week 16||28.6|5.1|
91682594|NCT04058067|183255289|SUPERIORITY||Difference - %|15.4|||||TWO_SIDED|95.0|3.1|26.6|||Clopper-Pearson exact method|||Week 18||26.6|3.1|
91682595|NCT04058067|183255289|SUPERIORITY||Difference - %|15.7|||||TWO_SIDED|95.0|3.5|27.1|||Clopper-Pearson exact method|||Week 20||27.1|3.5|
91682596|NCT04058067|183255289|SUPERIORITY||Difference - %|19.1|||||TWO_SIDED|95.0|7.2|30.2|||Clopper-Pearson exact method|||Week 24||30.2|7.2|
91682597|NCT04058067|183255289|SUPERIORITY||Difference - %|16.4|||||TWO_SIDED|95.0|4.9|27.9|||Clopper-Pearson exact method|||Week 28||27.9|4.9|
91682598|NCT04058067|183255289|SUPERIORITY||Difference - %|12.1|||||TWO_SIDED|95.0|0.4|24.4|||Clopper-Pearson exact method|||Week 32||24.4|0.4|
91682599|NCT04058067|183255289|SUPERIORITY||Difference - %|6.0|||||TWO_SIDED|95.0|-5.9|18.0|||Clopper-Pearson exact method|||Week 36||18.0|-5.9|
91682600|NCT04058067|183255289|SUPERIORITY||Difference - %|15.2|||||TWO_SIDED|95.0|3.3|26.1|||Clopper-Pearson exact method|||Week 40||26.1|3.3|
91682601|NCT04058067|183255289|SUPERIORITY||Difference - %|13.2|||||TWO_SIDED|95.0|1.9|25.7|||Clopper-Pearson exact method|||Week 44||25.7|1.9|
91682602|NCT04058067|183255289|SUPERIORITY||Difference - %|11.9|||||TWO_SIDED|95.0|-0.8|23.6|||Clopper-Pearson exact method|||Week 48||23.6|-0.8|
91682603|NCT04058067|183255289|SUPERIORITY||Difference - %|17.9|||||TWO_SIDED|95.0|5.8|30.5|||Clopper-Pearson exact method|||Week 52||30.5|5.8|
91682604|NCT04058067|183255290|SUPERIORITY||Difference|0.9|||||TWO_SIDED|95.0|0.8|3.6|||Clopper-Pearson exact method|||||3.6|0.8|
91682605|NCT04058067|183255291|SUPERIORITY||Difference|-4.3|||||TWO_SIDED|95.0|-13.2|4.6|||Clopper-Pearson exact method|||||4.6|-13.2|
91682606|NCT04058067|183255292|SUPERIORITY||Difference|1.0|||||TWO_SIDED|95.0|-10.5|12.4|||Clopper-Pearson exact method|||||12.4|-10.5|
91682607|NCT04058067|183255297|OTHER|Descriptive, Week 28|Difference - %|-2.4|||||TWO_SIDED|95.0|-13.9|8.8|||Clopper-Pearson exact method|||Week 28||8.8|-13.9|
91682608|NCT04058067|183255297|OTHER|Descriptive, Week 52|Difference - %|-2.8|||||TWO_SIDED|95.0|-14.1|9.0|||Clopper-Pearson exact method|||Week 52||9.0|-14.1|
91682609|NCT04058067|183255299|OTHER|Descriptive, Week 28|Difference - %|4.2|||||TWO_SIDED|95.0|-4.1|12.6|||Clopper-Pearson exact method|||Week 28||12.6|-4.1|
91682610|NCT04058067|183255299|OTHER|Descriptive, Week 52|Difference - %|-0.5|||||TWO_SIDED|95.0|-10.5|9.3|||Clopper-Pearson exact method|||Week 52||9.3|-10.5|
91682611|NCT04058067|183255301|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
91682612|NCT04058067|183255303|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
91682613|NCT04058067|183255304|SUPERIORITY||LS mean difference|-0.9||||||95.0|-4.1|2.3|||ANCOVA|||Week 28||2.3|-4.1|
91682614|NCT04058067|183255304|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|95.0|-3.1|3.3|||ANCOVA|||Week 52||3.3|-3.1|
91682615|NCT05502081|183255341|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682616|NCT05502081|183255341|SUPERIORITY|||||||0.176|||||||Kruskal-Wallis|||||||0.176
91682617|NCT05502081|183255341|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682618|NCT05502081|183255341|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682619|NCT05502081|183255342|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
91682620|NCT05502081|183255342|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|||||||0.021
91718806|NCT01259245|183330278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_DEVIATION|4.477||0.345|TWO_SIDED|95.0|-6.627|2.327|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.327|-6.627|0.345
91718807|NCT01259245|183330279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|4.062||0.413|TWO_SIDED|95.0|-5.753|2.372|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.372|-5.753|0.413
91718808|NCT01259245|183330280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.049|STANDARD_DEVIATION|8.89||0.004|TWO_SIDED|95.0|4.159|21.939|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||21.939|4.159|0.004
91718809|NCT01259245|183330281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_DEVIATION|0.226||0.56|TWO_SIDED|95.0|-0.1|0.184|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.184|-0.100|0.560
91718810|NCT01259245|183330282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_DEVIATION|0.088||0.425|TWO_SIDED|95.0|-0.054|0.128|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.128|-0.054|0.425
91718811|NCT01259245|183330283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|5.2||0.528|TWO_SIDED|95.0|-3.5|6.8|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||6.8|-3.5|0.528
91718812|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).|GMC ratio|0.16|||||TWO_SIDED|95.0|0.14|0.18||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1."||0.18|0.14|
91718813|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1106 in the 105553 10Pn Group; GMC= 1.45 µg/mL with 95% CI = (1.38 to 1.53).|GMC ratio|0.22|||||TWO_SIDED|95.0|0.2|0.25||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4."||0.25|0.2|
91718814|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.70 µg/mL with 95% CI = (1.62 to 1.78).|GMC ratio|0.26|||||TWO_SIDED|95.0|0.23|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5."||0.29|0.23|
91718815|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 0.33 µg/mL with 95% CI = (0.30 to 0.36).|GMC ratio|0.19|||||TWO_SIDED|95.0|0.16|0.23||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B."||0.23|0.16|
91718816|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1107 in the 105553 10Pn Group; GMC= 1.72 µg/mL with 95% CI = (1.64 to 1.80).|GMC ratio|0.28|||||TWO_SIDED|95.0|0.25|0.31||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F."||0.31|0.25|
91527620|NCT01976364|182930480|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.3|
91682621|NCT05502081|183255342|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||0.42
91682622|NCT05502081|183255342|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
91682623|NCT05502081|183255343|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
91682624|NCT05502081|183255344|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
91682625|NCT05502081|183255344|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
91682626|NCT05502081|183255344|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91682627|NCT05502081|183255344|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91682628|NCT05502081|183255345|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682629|NCT05502081|183255345|SUPERIORITY|||||||0.119|||||||Kruskal-Wallis|||||||0.119
91682630|NCT05502081|183255345|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682631|NCT05502081|183255345|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682632|NCT05502081|183255346|SUPERIORITY|||||||0.933|||||||Kruskal-Wallis|||||||0.933
91682633|NCT05502081|183255347|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
91682634|NCT05502081|183255347|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
91682635|NCT05502081|183255347|SUPERIORITY|||||||0.185|||||||Kruskal-Wallis|||||||0.185
91682636|NCT05502081|183255347|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91722502|NCT06001021|183337812|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|15.15||0|TWO_SIDED|90.0|19.41|25.12||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||25.12|19.41|0.000
91527621|NCT01976364|182930480|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.3|-0.5|
91682637|NCT05502081|183255348|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682638|NCT05502081|183255348|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91682639|NCT05502081|183255348|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682640|NCT05502081|183255348|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682641|NCT05502081|183255349|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682642|NCT05502081|183255349|SUPERIORITY|||||||0.758|||||||Kruskal-Wallis|||||||0.758
91682643|NCT05502081|183255349|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682644|NCT05502081|183255349|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682645|NCT05502081|183255350|SUPERIORITY|||||||0.412|||||||Kruskal-Wallis|||||||0.412
91682646|NCT05502081|183255351|SUPERIORITY|||||||0.106|||||||Kruskal-Wallis|||||||0.106
91682647|NCT05502081|183255352|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91682648|NCT05502081|183255352|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
91682649|NCT05502081|183255352|SUPERIORITY|||||||0.156|||||||Kruskal-Wallis|||||||0.156
91682650|NCT05502081|183255352|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91682651|NCT05502081|183255353|SUPERIORITY|||||||0.219|||||||Kruskal-Wallis|||||||0.219
91682652|NCT05502081|183255354|SUPERIORITY|||||||0.298|||||||Kruskal-Wallis|||||||0.298
91682653|NCT05502081|183255355|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
91682654|NCT05502081|183255355|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
91682655|NCT05502081|183255355|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91682656|NCT05502081|183255355|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
91682657|NCT05502081|183255356|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
91682658|NCT05502081|183255356|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
91682659|NCT05502081|183255356|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91682660|NCT05502081|183255356|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
91682661|NCT05502081|183255357|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
91682662|NCT05502081|183255357|SUPERIORITY|||||||0.557|||||||Kruskal-Wallis|||||||0.557
91682663|NCT05502081|183255357|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91682664|NCT05502081|183255357|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91682665|NCT05502081|183255358|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682666|NCT05502081|183255358|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
91682667|NCT05502081|183255358|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682668|NCT05502081|183255358|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682669|NCT05502081|183255359|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682670|NCT05502081|183255359|SUPERIORITY|||||||0.891|||||||Kruskal-Wallis|||||||0.891
91682671|NCT05502081|183255359|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682672|NCT05502081|183255359|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682673|NCT05502081|183255360|SUPERIORITY|||||||0.516|||||||Kruskal-Wallis|||||||0.516
91682674|NCT05502081|183255361|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||||||0.264
91682675|NCT05502081|183255362|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682676|NCT05502081|183255362|SUPERIORITY|||||||0.256|||||||Kruskal-Wallis|||||||0.256
91682677|NCT05502081|183255362|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682678|NCT05502081|183255362|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682679|NCT05502081|183255363|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
91682680|NCT05502081|183255363|SUPERIORITY|||||||0.797|||||||Kruskal-Wallis|||||||0.797
91682681|NCT05502081|183255363|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91682682|NCT05502081|183255363|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91682683|NCT05502081|183255364|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91682684|NCT05502081|183255365|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682685|NCT05502081|183255365|SUPERIORITY|||||||0.982|||||||Kruskal-Wallis|||||||0.982
91682686|NCT05502081|183255365|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682687|NCT05502081|183255365|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682688|NCT05502081|183255366|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
91682689|NCT05502081|183255366|SUPERIORITY|||||||0.136|||||||Kruskal-Wallis|||||||0.136
91682690|NCT05502081|183255366|SUPERIORITY|||||||0.062|||||||Kruskal-Wallis|||||||0.062
91682691|NCT05502081|183255366|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
91682692|NCT05502081|183255367|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
91682693|NCT05502081|183255368|SUPERIORITY|||||||0.687|||||||Kruskal-Wallis|||||||0.687
91682694|NCT05502081|183255369|SUPERIORITY|||||||0.278|||||||Kruskal-Wallis|||||||0.278
91682695|NCT05502081|183255370|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
91682696|NCT05502081|183255371|SUPERIORITY|||||||0.574|||||||Kruskal-Wallis|||||||0.574
91682697|NCT05502081|183255372|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
91682698|NCT05502081|183255372|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
91682699|NCT05502081|183255372|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||||||0.041
91682700|NCT05502081|183255372|SUPERIORITY|||||||0.616|||||||Kruskal-Wallis|||||||0.616
91682701|NCT05502081|183255373|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
91682702|NCT05502081|183255374|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682703|NCT05502081|183255374|SUPERIORITY|||||||0.208|||||||Kruskal-Wallis|||||||0.208
91682704|NCT05502081|183255374|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682705|NCT05502081|183255374|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91682706|NCT05502081|183255375|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||0.088
91682707|NCT05502081|183255376|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91682708|NCT05502081|183255377|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
91682709|NCT05502081|183255377|SUPERIORITY|||||||0.151|||||||Kruskal-Wallis|||||||0.151
91682710|NCT05502081|183255377|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91682711|NCT05502081|183255377|SUPERIORITY|||||||0.035|||||||Kruskal-Wallis|||||||0.035
91682712|NCT05502081|183255378|SUPERIORITY|||||||0.037|||||||Kruskal-Wallis|||||||0.037
91682713|NCT05502081|183255378|SUPERIORITY|||||||0.997|||||||Kruskal-Wallis|||||||0.997
91682714|NCT05502081|183255378|SUPERIORITY|||||||0.016|||||||Kruskal-Wallis|||||||0.016
91682715|NCT05502081|183255378|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
91682716|NCT05502081|183255379|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91682717|NCT05502081|183255380|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||||||0.047
91682718|NCT05502081|183255380|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||||||0.04
91682719|NCT05502081|183255380|SUPERIORITY|||||||0.036|||||||Kruskal-Wallis|||||||0.036
91682720|NCT05502081|183255380|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
91682721|NCT05502081|183255381|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
91682722|NCT05502081|183255381|SUPERIORITY|||||||0.027|||||||Kruskal-Wallis|||||||0.027
91682723|NCT05502081|183255381|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
91682724|NCT05502081|183255381|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
91682725|NCT05502081|183255382|SUPERIORITY|||||||0.814|||||||Kruskal-Wallis|||||||0.814
91682726|NCT05502081|183255383|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91682727|NCT05502081|183255384|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682728|NCT05502081|183255384|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682729|NCT05502081|183255384|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682730|NCT05502081|183255384|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||||||0.971
91682731|NCT05502081|183255385|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91682732|NCT05502081|183255385|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682733|NCT05502081|183255386|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
91682734|NCT05502081|183255386|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
91682735|NCT05502081|183255386|SUPERIORITY|||||||0.452|||||||Kruskal-Wallis|||||||0.452
91682736|NCT05502081|183255386|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
91682737|NCT05502081|183255387|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91682738|NCT05502081|183255388|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
91682739|NCT05502081|183255388|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
91682740|NCT05502081|183255388|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91682741|NCT05502081|183255388|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
91682742|NCT05502081|183255389|SUPERIORITY|||||||0.423|||||||Kruskal-Wallis|||||||0.423
91682743|NCT05502081|183255390|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||||||0.429
91682744|NCT05502081|183255391|SUPERIORITY|||||||0.089|||||||Kruskal-Wallis|||||||0.089
91682745|NCT05502081|183255392|SUPERIORITY|||||||0.222|||||||Kruskal-Wallis|||||||0.222
91682746|NCT05502081|183255393|SUPERIORITY|||||||0.252|||||||Kruskal-Wallis|||||||0.252
91682747|NCT05502081|183255394|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91682748|NCT05502081|183255395|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
91682749|NCT05502081|183255395|SUPERIORITY|||||||0.382|||||||Kruskal-Wallis|||||||0.382
91682750|NCT05502081|183255395|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
91682751|NCT05502081|183255395|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
91682752|NCT05502081|183255396|SUPERIORITY|||||||0.457|||||||Kruskal-Wallis|||||||0.457
91682753|NCT05502081|183255397|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91682754|NCT05502081|183255398|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91682755|NCT05502081|183255398|SUPERIORITY|||||||0.605|||||||Kruskal-Wallis|||||||0.605
91682756|NCT05502081|183255398|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91526870|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.271|TWO_SIDED|95.0|-0.26|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.26|0.271
91682757|NCT05502081|183255398|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91682758|NCT05502081|183255399|SUPERIORITY|||||||0.293|||||||Kruskal-Wallis|||||||0.293
91682759|NCT05502081|183255400|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91682760|NCT05502081|183255401|SUPERIORITY|||||||0.36|||||||Kruskal-Wallis|||||||0.36
91682761|NCT05502081|183255402|SUPERIORITY|||||||0.404|||||||Kruskal-Wallis|||||||0.404
91682762|NCT05502081|183255403|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682763|NCT05502081|183255403|SUPERIORITY|||||||0.234|||||||Kruskal-Wallis|||||||0.234
91682764|NCT05502081|183255403|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682765|NCT05502081|183255403|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682766|NCT05502081|183255404|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682767|NCT05502081|183255404|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
91682768|NCT05502081|183255404|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682769|NCT05502081|183255404|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682770|NCT05502081|183255405|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682771|NCT05502081|183255405|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
91682772|NCT05502081|183255405|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682773|NCT05502081|183255405|SUPERIORITY|||||||0.213|||||||Kruskal-Wallis|||||||0.213
91682774|NCT05502081|183255406|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682775|NCT05502081|183255406|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||0.478
91682776|NCT05502081|183255406|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682777|NCT05502081|183255406|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682778|NCT05502081|183255407|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682779|NCT05502081|183255407|SUPERIORITY|||||||0.413|||||||Kruskal-Wallis|||||||0.413
91682780|NCT05502081|183255407|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682781|NCT05502081|183255407|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682782|NCT05502081|183255408|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
91682783|NCT05502081|183255408|SUPERIORITY|||||||0.155|||||||Kruskal-Wallis|||||||0.155
91682784|NCT05502081|183255408|SUPERIORITY|||||||0.022|||||||Kruskal-Wallis|||||||0.022
91682785|NCT05502081|183255408|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91682786|NCT05502081|183255409|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91682787|NCT05502081|183255410|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682788|NCT05502081|183255410|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
91682789|NCT05502081|183255410|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91682790|NCT05502081|183255410|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
91682791|NCT05502081|183255411|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
91682792|NCT05502081|183255412|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
91682793|NCT00191165|183255423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.34||95.0|-0.5|1.4|||ANOVA||Mean Difference = High Dose - Label Dose|||1.40|-0.50|0.340
91682794|NCT00191165|183255424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.388||95.0|-0.21|0.53||P-value for 12-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.53|-0.21|0.388
91682795|NCT00191165|183255424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.061||95.0|-0.02|0.99||P-value for 24-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.99|-0.02|0.061
91682796|NCT00191165|183255425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.088||95.0|-0.18|2.44|||ANOVA||Mean Difference = High Dose - Label Dose|||2.44|-0.18|0.088
91682797|NCT03200912|183255426|EQUIVALENCE|Primary Efficacy Endpoint - AK Complete Clearance Rates at Day 57 (PP and mITT Populations)|Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-7.55|12.14||||||||12.14|-7.55|
91682798|NCT03421730|183255431|OTHER||Geometric mean ratio (%)|8.69|||||TWO_SIDED||||||||A: n=6; D: n=5||The intra-subject coefficient of variation was 25.33%.|||
91682799|NCT03421730|183255431|OTHER||Geometric mean ratio (%)|28.18|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
91682800|NCT03421730|183255431|OTHER||Geometric mean ratio (%)|59.51|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
91682801|NCT03421730|183255432|OTHER||Geometric mean ratio (%)|13.35|||||TWO_SIDED||||||||A: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%.|||
91682802|NCT03421730|183255432|OTHER||Geometric mean ratio (%)|35.97|||||TWO_SIDED||||||||B: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
91682803|NCT03421730|183255432|OTHER||Geometric mean ratio (%)|76.98|||||TWO_SIDED||||||||C: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
91682804|NCT03421730|183255433|OTHER||Geometric mean ratio (%)|9.55|||||TWO_SIDED||||||||A: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
91682805|NCT03421730|183255433|OTHER||Geometric mean ratio (%)|32.42|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
91682806|NCT03421730|183255433|OTHER||Geometric mean ratio (%)|59.75|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
91682807|NCT00555152|183255448|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
91722503|NCT06001021|183337813|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.44|STANDARD_DEVIATION|7.55||0|TWO_SIDED|90.0|15.02|17.87||The significance level is 0.10 with 90% confidence interval|ANCOVA|||Physical Domain of Quality of Life||17.87|15.02|0.000
91682808|NCT01096368|183255471|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.229|TWO_SIDED|90.46|0.627|1.197||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|The study was designed to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 1-sided log-rank test. The planned sample size was 160 subjects per arm. 85 EFS events were needed, which were expected after 8 years of accrual and 2 years of follow-up. At 5% type 1 error, the study had 93% power to detect an increase in 2-year EFS from 75% (RT alone) to 87% (RT+maintenance). The design also incorporated interim analyses for futility and efficacy.||1.197|0.627|0.229
91682809|NCT01096368|183255472|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.172|TWO_SIDED|90.46|0.463|1.238||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|It was planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 1-sided log-rank test using the planned sample size of 160 subjects per arm which was optimized for the EFS outcome. A one-sided significance threshold of 5% was planned for this comparison as well.||1.238|0.463|0.172
91682810|NCT01096368|183255473|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.096|TWO_SIDED|95.0|0.461|1.068||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.068|0.461|0.096
91682811|NCT01096368|183255474|SUPERIORITY||Hazard Ratio (HR)|2.684||||0.041|TWO_SIDED|95.0|1.004|7.175||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||7.175|1.004|0.041
91682812|NCT01096368|183255475|SUPERIORITY||Hazard Ratio (HR)|0.547||||0.067|TWO_SIDED|95.0|0.284|1.053||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over death of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.053|0.284|0.067
91682813|NCT01096368|183255476|SUPERIORITY||Hazard Ratio (HR)|3.601||||0.094|TWO_SIDED|95.0|0.724|17.902||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||17.902|0.724|0.094
91682814|NCT02373189|183255481|SUPERIORITY|||||||0.05||||||The P-value indicated above is calculated.|paired t-test|means at pre and post treatment were compared within subject.||||||0.05
91682815|NCT02373189|183255482|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91682816|NCT02151877|183255483|OTHER||||||>|0.05||||||This test applies to the first marker, cardiac troponin I.|t-test, 2 sided|||Null: mean cardiac troponin I changes in the NO group = mean cardiac troponin I changes in the control||||>0.05
91682817|NCT02151877|183255484|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null: NO group fluid balances are the same as the control||||>0.05
91682818|NCT03095638|183255491|OTHER||Ratio|1.0084|||||TWO_SIDED|90.0|0.8626|1.1789||||||||1.1789|0.8626|
91682819|NCT03095638|183255492|OTHER||Ratio|1.0121|||||TWO_SIDED|90.0|0.8648|1.1845||||||||1.1845|0.8648|
91682820|NCT03095638|183255493|OTHER||Ration|1.0329|||||TWO_SIDED|90.0|0.8623|1.2373||||||||1.2373|0.8623|
91682821|NCT03095638|183255494|OTHER||Ratio|1.6242|||||TWO_SIDED|90.0|1.4986|1.7604||||||||1.7604|1.4986|
91682822|NCT03095638|183255494|OTHER||Ratio|1.5448|||||TWO_SIDED|90.0|1.4253|1.6743||||||||1.6743|1.4253|
91682823|NCT03095638|183255495|OTHER||Ratio|1.6292|||||TWO_SIDED|90.0|1.503|1.7661||||||||1.7661|1.5030|
91682824|NCT03095638|183255495|OTHER||Ratio|1.5519|||||TWO_SIDED|90.0|1.4317|1.6822||||||||1.6822|1.4317|
91682825|NCT03095638|183255496|OTHER||Ratio|1.7933|||||TWO_SIDED|90.0|1.6226|1.9819||||||||1.9819|1.6226|
91682826|NCT03095638|183255496|OTHER||Ratio|1.7974|||||TWO_SIDED|90.0|1.6263|1.9865||||||||1.9865|1.6263|
91682827|NCT01158573|183255558|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Hypothesis that leptin levels in OA is not different from the other 3 groups.|ANOVA|||||||<0.0001
91682828|NCT01158573|183255559|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.002
91682829|NCT01158573|183255560|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANOVA|||||||0.725
91682830|NCT01158573|183255561|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||||||0.16
91682831|NCT02980874|183255564|SUPERIORITY||Difference in percentages|-6.1||||0.187|TWO_SIDED|95.0|-15.2|3.0||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.0|-15.2|0.187
91682832|NCT02450526|183255567|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|94.3|||<|0.0001|TWO_SIDED|95.0|90.8|97.7||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||97.7|90.8|<0.0001
91682833|NCT02450526|183255568|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|87.5|||<|0.0001|TWO_SIDED|95.0|82.5|92.4||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||92.4|82.5|<0.0001
91682834|NCT02450526|183255569|NON_INFERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment Difference|-2.4|||||TWO_SIDED|95.0|-6.7|1.9||||||The non-inferiority of Dysport® to Botox on the ILA at maximum frown was tested using a multivariate logistic regression model||1.9|-6.7|
91682835|NCT02450526|183255570|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|73.8|||<|0.0001|TWO_SIDED|95.0|59.1|88.4|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.4|59.1|<0.0001
91682836|NCT02450526|183255571|SUPERIORITY|The comparison between mean scores of SGA at Treatment Cycle 1, Day 29 is based on 2 separate linear mixed models, adjusting on the two stratification parameters, gender and baseline ILA severity score, and the centre.|Treatment Difference|2.603|||<|0.0001|TWO_SIDED|95.0|2.327|2.878||The test was two-sided at the significance level of 0.05|Mixed Models Analysis|||Superiority analysis of Dysport® to placebo was tested using a linear mixed model.||2.878|2.327|<0.0001
91682837|NCT02450526|183255572|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|83.7|||<|0.0001|TWO_SIDED|95.0|78.7|88.7|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.7|78.7|<0.0001
91682838|NCT00911807|183255587|SUPERIORITY_OR_OTHER||Mean Square (Factor Treatment)|19.59||||0.6348||||||ANCOVA F-test. The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|ANCOVA|ANCOVA with the week 28 ADAS-cog+ change score as dependent variable and the ADAS-cog+ baseline score as a covariate.||The null-hypothesis stated no differences between the three treatment groups regarding the mean change from baseline in ADAS-cog+ at week 28. A sample size of approximately 60 evaluable patients per treatment arm was estimated to allow for the detection of a significant group difference of two points in ADAS-cog+ week 28 change score (standard deviation \[SD\] 3.3) between the three groups with a power of \> 80% and a probability level of alpha = 0.05 (two-sided).||||0.6348
91682839|NCT00911807|183255587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.583||95.0|-2.891|1.63||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'||1.630|-2.891|0.5830
91682840|NCT00911807|183255587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3434||95.0|-3.324|1.163||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.163|-3.324|0.3434
91682841|NCT00911807|183255587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.6962||95.0|-2.719|1.819||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.819|-2.719|0.6962
91682842|NCT01997229|183255641|SUPERIORITY||Mean Difference (Net)|-11.7||||0.0698|TWO_SIDED|95.0|-24.33|0.96|||ANCOVA|||||0.96|-24.33|0.0698
91682843|NCT04568031|183255647|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91682844|NCT04568031|183255647|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91682845|NCT04568031|183255652|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91682846|NCT04568031|183255652|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91682847|NCT04568031|183255655|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91682848|NCT04568031|183255655|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91526871|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.612|TWO_SIDED|95.0|-0.43|0.73||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.73|-0.43|0.612
91526872|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.465|TWO_SIDED|95.0|-0.3|0.65||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.65|-0.30|0.465
91682849|NCT02304458|183255659|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|3.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is 3 mg/kg Nivolumab|||||
91682850|NCT04874636|183255672|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.59|0.75|||||Posterior mean difference with 95% credible interval is reported.|||0.75|-0.59|
91682851|NCT04874636|183255673|SUPERIORITY||Posterior Mean Difference|0.49|||||TWO_SIDED|95.0|-1.02|2.0|||||Posterior mean difference with 95% credible interval is reported.|||2.00|-1.02|
91682852|NCT04874636|183255674|SUPERIORITY||Posterior Mean Difference|0.14|||||TWO_SIDED|95.0|-0.27|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.27|
91682853|NCT04874636|183255675|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.43|1.02|||||Posterior mean difference with 95% credible interval is reported.|||1.02|-0.43|
91682854|NCT04874636|183255676|SUPERIORITY||Posterior Mean Difference|7.9|||||TWO_SIDED|95.0|-0.32|16.14|||||Posterior mean difference with 95% credible interval is reported.|||16.14|-0.32|
91682855|NCT04874636|183255677|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.65|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.65|
91682856|NCT04874636|183255678|SUPERIORITY||Posterior Mean Difference|-34.98|||||TWO_SIDED|95.0|-176.34|106.69|||||Posterior mean difference with 95% credible interval is reported.|||106.69|-176.34|
91682857|NCT04874636|183255679|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.1|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-0.10|
91682858|NCT04188301|183255684|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
91682859|NCT04188301|183255684|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
91682860|NCT04188301|183255684|SUPERIORITY|IA vs IDA treatment groups for living female O. volvulus worms in nodules after treatment.|Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||||2.15|0.97|0.068
91682861|NCT04188301|183255684|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
91682862|NCT04188301|183255687|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
91682863|NCT04188301|183255687|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
91682864|NCT04188301|183255687|SUPERIORITY||Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA groups for living female O. volvulus worms in nodules after treatment.||2.15|0.97|0.068
91682865|NCT04188301|183255687|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
91682866|NCT04188301|183255690|SUPERIORITY||Odds Ratio (OR)|1.66||||0.134|TWO_SIDED|95.0|0.85|3.21||Adjusted p values were model-adjusted for repeated measurements per person. Participant level random effects were included in the model to adjust for multiple worms/person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA in fertile female O. volvulus worms in nodules after treatment.||3.21|0.85|0.134
91682867|NCT04188301|183255690|SUPERIORITY||Odds Ratio (OR)|2.23||||0.023|TWO_SIDED|95.0|1.12|4.44||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||4.44|1.12|0.023
91682868|NCT04188301|183255690|SUPERIORITY||Odds Ratio (OR)|1.32||||0.43|TWO_SIDED|95.0|0.64|2.85||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA1 vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||2.85|.64|0.430
91682869|NCT04188301|183255690|SUPERIORITY||Odds Ratio (OR)|1.91||||0.023|TWO_SIDED|95.0|1.09|3.34||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA treatment groups for fertile female O. volvulus worms in nodules after treatment.||3.34|1.09|0.023
91682870|NCT03564444|183255722|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
91682871|NCT03246646|183255728|SUPERIORITY||Z test of proportions|0.66|||>|0.05|ONE_SIDED||||||Z test of independent proportions|||||||>.05
91682872|NCT02569112|183255729|SUPERIORITY|A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Used Wilcoxon Matched-Pairs Signed-Ranks test||The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.||||<0.01
91682873|NCT00319982|183255730|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in E' Velocity comparing baseline and final study visits||||0.75
91682874|NCT00319982|183255731|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Fisher Exact|||Adverse Events||||0.99
91682875|NCT00319982|183255732|SUPERIORITY_OR_OTHER||||||>|0.06|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||>0.06
91682876|NCT00319982|183255733|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in LV End-Diastolic Diameter z-score from baseline to final visit||||<0.001
91682877|NCT00319982|183255735|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Percentage adherent to study medication||||0.08
91682878|NCT00319982|183255736|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||0.15
91682879|NCT00758680|183255738|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|37.63||||0.015|TWO_SIDED|95.0|12.58|62.68|||Mixed Effect Model|||||62.68|12.58|0.015
91682880|NCT00758680|183255738|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|92.3|||<|0.001|TWO_SIDED|95.0|67.56|117.04|||Mixed Effect Model|||||117.04|67.56|<0.001
91682881|NCT03480386|183255742|SUPERIORITY|||||||0.0788|||||||t-test, 2 sided|||Daily Light Physical Activity||||0.0788
91682882|NCT03480386|183255742|SUPERIORITY|||||||0.0742|||||||t-test, 2 sided|||Daily Moderate Physical Activity||||0.0742
91682883|NCT03480386|183255743|SUPERIORITY|||||||0.0113|||||||t-test, 2 sided|||||||0.0113
91682884|NCT03480386|183255744|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
91682885|NCT03480386|183255745|SUPERIORITY|||||||0.2216|||||||t-test, 2 sided|||||||0.2216
91682886|NCT03480386|183255746|SUPERIORITY|||||||0.4762|||||||t-test, 2 sided|||||||0.4762
91682887|NCT03480386|183255747|SUPERIORITY|||||||0.0068|||||||t-test, 2 sided|||||||0.0068
91682888|NCT03480386|183255748|SUPERIORITY|||||||0.1548|||||||t-test, 2 sided|||||||0.1548
91682889|NCT03589768|183255765|OTHER|N/A, Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-11.9|10.3|||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||10.3|-11.9|
91682890|NCT03589768|183255766|SUPERIORITY||Risk Difference (RD)|4.62||||0.559|TWO_SIDED|95.0|-6.25|15.5|||Fisher Exact||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||15.5|-6.25|0.559
91682891|NCT03589768|183255767|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-9.3|9.8|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|9.8|-9.3|
91682892|NCT03589768|183255768|SUPERIORITY||Risk Difference (RD)|6.06||||0.29|TWO_SIDED|95.0|-3.82|15.9|||Fisher Exact||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|15.9|-3.82|0.290
91682893|NCT03589768|183255770|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-6.4|7.3|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|7.3|-6.4|
91682894|NCT03589768|183255771|SUPERIORITY||Ratio|7.0|||<|0.0001|TWO_SIDED|95.0|4.6|10.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth day timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|10.7|4.6|<0.0001
91682895|NCT03589768|183255771|SUPERIORITY||Ratio|4.8|||<|0.0001|TWO_SIDED|95.0|3.2|7.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for Prior to receipt of first dose of DTwP (approximately 6 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|7.3|3.2|<0.0001
91682896|NCT03589768|183255771|SUPERIORITY||Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.8|4.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of first dose of DTwP (approximately 10 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|4.8|1.8|<0.0001
91682897|NCT03589768|183255771|SUPERIORITY||Ratio|0.3||||0.0068|TWO_SIDED|95.0|0.1|0.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.7|0.1|0.0068
91682898|NCT03589768|183255771|SUPERIORITY||Ratio|0.3||||0.0003|TWO_SIDED|95.0|0.1|0.5|||t-test, 2 sided|Test compares differences in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.5|0.1|0.0003
91682899|NCT03589768|183255772|SUPERIORITY||Ratio|0.9||||0.7102|TWO_SIDED|95.0|0.7|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.7|0.7102
91682900|NCT03589768|183255772|SUPERIORITY||Ratio|8.7|||<|0.0001|TWO_SIDED|95.0|6.2|12.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|12.0|6.2|<0.0001
91682901|NCT03589768|183255772|SUPERIORITY||Ratio|4.7|||<|0.0001|TWO_SIDED|95.0|3.3|6.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|6.6|3.3|<0.0001
91682902|NCT03589768|183255772|SUPERIORITY||Ratio|3.3|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|5.2|2.1|<0.0001
91682903|NCT03589768|183255773|SUPERIORITY||Ratio|1.1||||0.7039|TWO_SIDED|95.0|0.8|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.8|0.7039
91682904|NCT03589768|183255773|SUPERIORITY||Ratio|18.5|||<|0.0001|TWO_SIDED|95.0|14.0|24.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|24.3|14.0|<0.0001
91682905|NCT03589768|183255773|SUPERIORITY||Ratio|10.5|||<|0.0001|TWO_SIDED|95.0|8.1|13.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|13.7|8.1|<0.0001
91682906|NCT03589768|183255773|SUPERIORITY||Ratio|7.4|||<|0.0001|TWO_SIDED|95.0|5.0|11.1|||t-test, 2 sided|Difference in log values back transformed into ratio.||Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|11.1|5.0|<0.0001
91682907|NCT03589768|183255774|SUPERIORITY||Ratio|1.2||||0.2897|TWO_SIDED|95.0|0.8|1.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.8|0.8|0.2897
91682908|NCT03589768|183255774|SUPERIORITY||Ratio|54.2|||<|0.0001|TWO_SIDED|95.0|35.6|82.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|82.4|35.6|<0.0001
91682909|NCT03589768|183255774|SUPERIORITY||Ratio|32.0|||<|0.0001|TWO_SIDED|95.0|20.6|49.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|49.7|20.6|<0.0001
91682910|NCT03589768|183255774|SUPERIORITY||Ratio|18.9|||<|0.0001|TWO_SIDED|95.0|10.4|34.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|34.2|10.4|<0.0001
91682911|NCT03589768|183255775|SUPERIORITY||Ratio|1.0||||0.837|TWO_SIDED|95.0|0.6|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.6|0.8370
91682912|NCT03589768|183255775|SUPERIORITY||Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|<0.0001
91682913|NCT03589768|183255775|SUPERIORITY||Ratio|0.7||||0.005|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0050
91682914|NCT03589768|183255775|SUPERIORITY||Ratio|0.8||||0.0689|TWO_SIDED|95.0|0.6|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.6|0.0689
91682915|NCT03589768|183255776|SUPERIORITY||Ratio|1.0||||0.8361|TWO_SIDED|95.0|0.7|1.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.6|0.7|0.8361
91682916|NCT03589768|183255776|SUPERIORITY||Ratio|0.9||||0.5136|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5136
91682917|NCT03589768|183255776|SUPERIORITY||Ratio|0.9||||0.4237|TWO_SIDED|95.0|0.6|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.6|0.4237
91682918|NCT03589768|183255776|SUPERIORITY||Ratio|0.7||||0.1607|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.4|0.1607
91682919|NCT03589768|183255777|SUPERIORITY||Ratio|13.7|||<|0.0001|TWO_SIDED|95.0|10.2|18.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|18.3|10.2|<0.0001
91682920|NCT03589768|183255777|SUPERIORITY||Ratio|10.8|||<|0.0001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|14.5|8.0|<0.0001
91682921|NCT03589768|183255777|SUPERIORITY||Ratio|10.2|||<|0.0001|TWO_SIDED|95.0|6.9|15.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio. Test compares difference in log values.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|15.2|6.9|<0.0001
91682922|NCT03589768|183255777|SUPERIORITY||Ratio|2.1||||0.0002|TWO_SIDED|95.0|1.4|3.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|3.0|1.4|0.0002
91682923|NCT03589768|183255777|SUPERIORITY||Ratio|1.2||||0.4828|TWO_SIDED|95.0|0.8|1.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.7|0.8|0.4828
91682924|NCT03589768|183255778|SUPERIORITY||Ratio|46.4|||<|0.0001|TWO_SIDED|95.0|26.6|81.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|81.0|26.6|<0.0001
91682925|NCT03589768|183255778|SUPERIORITY||Ratio|39.5|||<|0.0001|TWO_SIDED|95.0|24.0|65.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|65.0|24.0|<0.0001
91682926|NCT03589768|183255778|SUPERIORITY||Ratio|10.4|||<|0.0001|TWO_SIDED|95.0|6.1|17.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|17.9|6.1|<0.0001
91682927|NCT03589768|183255778|SUPERIORITY||Ratio|0.6||||0.0746|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0746
91682928|NCT03589768|183255778|SUPERIORITY||Ratio|0.7||||0.1532|TWO_SIDED|95.0|0.5|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.5|0.1532
91682929|NCT03589768|183255779|SUPERIORITY||Ratio|0.7||||0.0022|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0022
91682930|NCT03589768|183255779|SUPERIORITY||Ratio|0.7||||0.0008|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|0.0008
91682931|NCT03589768|183255779|SUPERIORITY||Ratio|0.7||||0.0261|TWO_SIDED|95.0|0.5|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.5|0.0261
91682932|NCT03589768|183255779|SUPERIORITY||Ratio|0.6||||0.0532|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0532
91682933|NCT03589768|183255779|SUPERIORITY||Ratio|0.9||||0.5587|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.5|0.5587
91682934|NCT03589768|183255780|SUPERIORITY||Ratio|0.9||||0.5056|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5056
91682935|NCT03589768|183255780|SUPERIORITY||Ratio|1.0||||0.9466|TWO_SIDED|95.0|0.7|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.7|0.9466
91718817|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1103 in the 105553 10Pn Group; GMC= 1.32 µg/mL with 95% CI = (1.25 to 1.38).|GMC ratio|0.24|||||TWO_SIDED|95.0|0.22|0.27||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V."||0.27|0.22|
91718818|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 2.90 µg/mL with 95% CI = (2.75 to 3.05).|GMC ratio|0.29|||||TWO_SIDED|95.0|0.25|0.33||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14."||0.33|0.25|
91718819|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 1.66 µg/mL with 95% CI = (1.56 to 1.77).|GMC ratio|0.1|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C."||0.12|0.09|
91718820|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.84 µg/mL with 95% CI = (1.71 to 1.98).|GMC ratio|0.11|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F."||0.12|0.09|
91718821|NCT01027845|183330314|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 0.53 µg/mL with 95% CI = (0.50 to 0.57).|GMC ratio|0.25|||||TWO_SIDED|95.0|0.21|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F."||0.29|0.21|
91718822|NCT03040726|183330391|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
91718823|NCT03040726|183330392|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
91718824|NCT03040726|183330393|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91718825|NCT03040726|183330394|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91718826|NCT05063448|183330401|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±2.47. Cases that fall outside of the confidence interval are considered to show reliable change.|Slope|1.0|||||TWO_SIDED|95.0|-1.47|3.47|||||Five cases fell outside of the upper confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score.||3.47|-1.47|
91718827|NCT05063448|183330401|SUPERIORITY|||||||0.022||||||This is not adjusted for multiple comparisons. A priori alpha is set at 95% with two tails.|t-test, 2 sided|t = 2.547, df = 16. N at time 3 = 18.||Paired samples t-test was used to compare group average pretest (time 1) and posttest (time 3) scores of self-perceptions of the parental role, a measure of parenting confidence.||||0.022
91527622|NCT01976364|182930481|OTHER||LS mean difference|0.26|||||TWO_SIDED|95.0|-2.51|3.02||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.02|-2.51|
91718828|NCT05063448|183330402|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±1.84. Cases that fall outside of the confidence interval are considered to show reliable change.|Slope|1.0|||||TWO_SIDED|95.0|-0.84|2.84|||||Three cases fell outside of the upper confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score.||2.84|-0.84|
91718829|NCT05063448|183330403|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±5.97. Cases that fall outside of the confidence interval are considered to show reliable change.|Slope|1.0|||||TWO_SIDED|95.0|-4.97|6.97||||Two cases demonstrated reliable and one case demonstrated a reliable increase in work-family role conflict at posttest.|Two cases fell outside of the upper confidence interval and one case fell outside of the lower confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score.||6.97|-4.97|
91718830|NCT05063448|183330404|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±4.78.|Slope|1.0|||||TWO_SIDED|95.0|-3.78|5.78|||||Three cases fell below the confidence interval and two cases fell above the confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score..||5.78|-3.78|
91718831|NCT05063448|183330405|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±3.37. Cases that fall outside of the confidence interval are considered to show reliable change.|Slope|1.0|||||TWO_SIDED|95.0|-2.27|4.37|||||Three cases fell below the lower confidence interval and two cases fell above the upper confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score.||4.37|-2.27|
91718832|NCT05063448|183330406|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±2.80. Cases that fall outside of the confidence interval are considered to show reliable change.|Slope|1.0|||||TWO_SIDED|95.0|-1.8|3.8|||||Two cases fell below the lower confidence interval and two cases fell above the upper confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score.||3.80|-1.80|
91526873|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.29|TWO_SIDED|95.0|-0.27|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.27|0.290
91526874|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.412|TWO_SIDED|95.0|-0.34|0.83||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.83|-0.34|0.412
91526875|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.07||||0.769|TWO_SIDED|95.0|-0.41|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.41|0.769
91526876|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.61|TWO_SIDED|95.0|-0.43|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.43|0.610
91682936|NCT03589768|183255780|SUPERIORITY||Ratio|1.1||||0.6911|TWO_SIDED|95.0|0.6|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.6|0.6911
91682937|NCT03589768|183255780|SUPERIORITY||Ratio|0.6||||0.0952|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0952
91682938|NCT03589768|183255780|SUPERIORITY||Ratio|1.2||||0.4134|TWO_SIDED|95.0|0.8|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.8|0.4134
91682939|NCT03589768|183255781|SUPERIORITY||Ratio|1.6||||0.0859|TWO_SIDED|95.0|0.9|2.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.6|0.9|0.0859
91682940|NCT03589768|183255781|SUPERIORITY||Ratio|1.4||||0.204|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.3|0.8|0.2040
91682941|NCT03589768|183255781|SUPERIORITY||Ratio|1.6||||0.0763|TWO_SIDED|95.0|1.0|2.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.7|1.0|0.0763
91682942|NCT03589768|183255781|SUPERIORITY||Ratio|0.5||||0.0836|TWO_SIDED|95.0|0.2|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.2|0.0836
91682943|NCT03589768|183255781|SUPERIORITY||Ratio|0.6||||0.0672|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0672
91682944|NCT03047330|183255798|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
91682945|NCT03047330|183255798|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91682946|NCT03047330|183255799|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
91682947|NCT03047330|183255799|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
91682948|NCT05773794|183255800|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
91682949|NCT05773794|183255800|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|||||||0.366
91682950|NCT05773794|183255800|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91682951|NCT05773794|183255801|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
91682952|NCT05773794|183255801|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91682953|NCT05773794|183255801|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91682954|NCT05773794|183255802|SUPERIORITY|||||||0.0196|||||||t-test, 2 sided|||||||0.0196
91682955|NCT05773794|183255802|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91682956|NCT05773794|183255802|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91682957|NCT01392963|183255816|OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91682958|NCT03783039|183255818|NON_INFERIORITY|10% margin|Risk Difference (RD)|0.0605|||<|0.0001|ONE_SIDED|97.5|-0.0189|||Testing whether the group difference in proportion of successes is \>-0.1 (Test Group - Control Group)|Farrington-Manning method||||||-0.0189|<0.0001
91682959|NCT03783039|183255819|OTHER||Difference in proportion of successes|0.0992|||||TWO_SIDED|95.0|0.0078|0.1906|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.1906|0.0078|
91682960|NCT03783039|183255820|OTHER||Difference in proportion of successes|0.0275|||||TWO_SIDED|95.0|-0.0312|0.0863|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.0863|-0.0312|
91682961|NCT01955837|183255829|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.035|TWO_SIDED|95.0|0.62|0.99|||Log Rank|||||0.99|0.62|0.035
91682962|NCT01955837|183255830|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.001|TWO_SIDED|95.0|0.34|0.54|||Log Rank|||||0.54|0.34|<0.001
91682963|NCT01955837|183255831|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.37|0.58|||Log Rank|||||0.58|0.37|<0.001
91682964|NCT01955837|183255832|SUPERIORITY||Difference in ORR|1.1||||0.554|TWO_SIDED|95.0|-0.1|2.4|||Fisher Exact|||||2.4|-0.1|0.554
91682965|NCT01955837|183255833|SUPERIORITY||Difference in DCR|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
91682966|NCT01955837|183255834|SUPERIORITY||Odds Ratio (OR)|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
91682967|NCT01955837|183255837|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.083|TWO_SIDED|95.0|0.57|1.04|||Log Rank|||||1.04|0.57|0.083
91526877|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.511|TWO_SIDED|95.0|-0.39|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.39|0.511
91682968|NCT01955837|183255838|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.228|TWO_SIDED|95.0|0.57|1.2|||Log Rank|||||1.20|0.57|0.228
91682969|NCT01955837|183255839|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.32|0.59||||||||0.59|0.32|
91682970|NCT01955837|183255840|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.31|0.65||||||||0.65|0.31|
91682971|NCT02563106|183255851|OTHER|The analysis of the primary endpoint was based on the mITT analysis set. Per-protocol and worse case analyses were performed as sensitivity analyses.The P-value was based on a one-sided z-test for the comparison of the treatment difference between the SYN-004 group and the Placebo group.|Relative Risk Reduction (%)|71.4||||0.045|TWO_SIDED|95.0|-35.9|94.0||Study was designed to provide 80% power to detect treatment effect with one-sided alpha = 0.05 on the primary endpoint. Based on the pre-specified z-test the one-sided P=0.045.|z-test|1-sided P=0.045.|Relative Risk Reduction in SYN-004 group compared to Placebo group.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1 dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.||94.0|-35.9|0.045
91682972|NCT02338193|183255852|SUPERIORITY||||||<|0.032|||||||ANOVA|||One Way ANOVA with Bonferroni contrast if p\>0.05||||<0.032
91682973|NCT02338193|183255853|SUPERIORITY||||||<|0.05|||||||ANOVA|One Way ANOVA with Bonferoni contrast test||||||<0.05
91682974|NCT02338193|183255854|SUPERIORITY||||||<|0.01|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.01
91682975|NCT02338193|183255855|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
91682976|NCT02338193|183255856|SUPERIORITY|||||||0.007|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.007
91682977|NCT02338193|183255857|SUPERIORITY|||||||0.023|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||0.023
91682978|NCT02338193|183255858|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
91682979|NCT02338193|183255859|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
91682980|NCT02338193|183255860|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||<0.001
91682981|NCT02338193|183255861|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.001
91682982|NCT02338193|183255862|SUPERIORITY||||||<|0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.004
91682983|NCT02338193|183255863|SUPERIORITY||||||<|0.02|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.02
91682984|NCT02338193|183255864|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
91682985|NCT02338193|183255865|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||>0.05
91682986|NCT02338193|183255866|SUPERIORITY||||||<|0.028|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.028
91682987|NCT02338193|183255867|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<.03
91682988|NCT05084716|183255901|SUPERIORITY||Odds Ratio (OR)|5.03|||<|0.0001|TWO_SIDED|95.0|2.08|12.13|||Regression, Logistic|||||12.13|2.08|<.0001
91682989|NCT05084716|183255901|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|3.48|16.59|||Regression, Logistic|||||16.59|3.48|<.0001
91682990|NCT05084716|183255902|SUPERIORITY||Odds Ratio (OR)|12.88|||<|0.0001|TWO_SIDED|95.0|5.96|27.85|||Regression, Logistic|||||27.85|5.96|<.0001
91682991|NCT05084716|183255902|SUPERIORITY||Odds Ratio (OR)|1.78||||0.001|TWO_SIDED|95.0|1.26|2.52|||Regression, Logistic|||||2.52|1.26|.001
91682992|NCT05084716|183255903|SUPERIORITY||Cohen's d for difference in proportions|1.28|||<|0.0001|TWO_SIDED|||||Odds Ratio is undefined and p-value from Fisher's Exact test is reported because 0% of PrEP users had ≥80% medication coverage pre-intervention.|Fisher Exact|||||||<.0001
91682993|NCT05084716|183255903|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.34|||Regression, Logistic|||||0.34|0.16|<.0001
91682994|NCT03839823|183255904|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.003|TWO_SIDED|95.0|0.429|0.87|||one-sided stratified logrank test|||||0.870|0.429|0.003
91682995|NCT03839823|183255905|SUPERIORITY||Hazard Ratio (HR)|0.497||||||95.0|0.363|0.68||||||||0.680|0.363|
91682996|NCT03839823|183255906|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
91682997|NCT03839823|183255907|SUPERIORITY|||||||0.255|||||||Cochran-Mantel-Haenszel|||||||0.255
91682998|NCT03839823|183255908|SUPERIORITY|||||||0.116|||||||Cochran-Mantel-Haenszel|||||||0.116
91682999|NCT03839823|183255909|SUPERIORITY||Hazard Ratio (HR)|0.762|||||TWO_SIDED|95.0|0.546|1.064||||||||1.064|0.546|
91683000|NCT04228783|183255923|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
91683001|NCT04228783|183255923|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
91683002|NCT04228783|183255923|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.9|1.2||||||||1.2|0.9|
91683003|NCT04228783|183255924|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.2||||||||1.2|0.8|
91683004|NCT04228783|183255924|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
91683005|NCT04228783|183255924|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
91683006|NCT00626392|183255929|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Cochran-Mantel-Haenszel|||||||0.010
91718833|NCT05063448|183330408|OTHER|Reliable change is calculated by multiplying the standard deviation of the measure by Cronbach's alpha reliability to determine the standard error of the measure. The standard error of the measure is multiplied by 1.96 to calculate a confidence interval around the line of no change, when the slope of pre-test to post-test = 1. Using time 3 parameters, the reliable change index for this scale was ±4.03. Cases that fall outside of the confidence interval are considered to show reliable change.|Slope|1.0|||||TWO_SIDED|95.0|-3.03|5.03|||||One case fell outside of the upper confidence interval, while 5 participants fell below the lower confidence interval.|Reliable change indices compare participants to themselves from Time 1 (baseline) and Time 3 (post-intervention). Reliable change indices measure whether the score change of individual participants is more than would be expected based on measurement error alone. Reliable change results are presented as number of participants who fell outside of the reliable change confidence interval in each direction indicating reliable increases or decreases in score.||5.03|-3.03|
91683007|NCT03151811|183255941|SUPERIORITY|||||||0.0311|||||||Log Rank|||||||0.0311
91683008|NCT01081834|183255952|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.088|-0.729|||ANCOVA|||||-0.729|-1.088|<0.001
91683009|NCT01081834|183255952|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.342|-0.985|||ANCOVA|||||-0.985|-1.342|<0.001
91683010|NCT01081834|183255954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|3.1|9.23|||Regression, Logistic|||||9.23|3.10|<0.001
91683011|NCT01081834|183255954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.61|||<|0.001|TWO_SIDED|95.0|8.14|26.25|||Regression, Logistic|||||26.25|8.14|<0.001
91683012|NCT01081834|183255955|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.5|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-42.22|-28.78|||ANCOVA|||||-28.78|-42.22|<0.001
91683013|NCT01081834|183255955|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-43.4|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-50.06|-36.69|||ANCOVA|||||-36.69|-50.06|<0.001
91683014|NCT01081834|183255956|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|5.629|<|0.001|TWO_SIDED|95.0|-59.12|-36.99|||ANCOVA|||||-36.99|-59.12|<0.001
91683015|NCT01081834|183255956|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-64.0|STANDARD_ERROR_OF_MEAN|5.616|<|0.001|TWO_SIDED|95.0|-75.02|-52.94|||ANCOVA|||||-52.94|-75.02|<0.001
91683016|NCT01081834|183255957|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.6|||ANCOVA|||||-1.6|-2.9|<0.001
91683017|NCT01081834|183255957|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-4.0|-2.6|||ANCOVA|||||-2.6|-4.0|<0.001
91683018|NCT01081834|183255958|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|1.093|<|0.001|TWO_SIDED|95.0|-5.86|-1.568|||ANCOVA|||||-1.568|-5.860|<0.001
91683019|NCT01081834|183255958|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.088|<|0.001|TWO_SIDED|95.0|-7.556|-3.28|||ANCOVA|||||-3.280|-7.556|<0.001
91683020|NCT01081834|183255959|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|4.8||0.267|TWO_SIDED|95.0|-14.8|4.1|||ANCOVA|||||4.1|-14.8|0.267
91683021|NCT01081834|183255959|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.8||0.034|TWO_SIDED|95.0|-19.6|-0.8|||ANCOVA|||||-0.8|-19.6|0.034
91683022|NCT01081834|183255960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.9|10.6|||ANCOVA|||||10.6|2.9|<0.001
91683023|NCT01081834|183255960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.9||0.002|TWO_SIDED|95.0|2.2|9.9|||ANCOVA|||||9.9|2.2|0.002
91683024|NCT00492024|183255975|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|Adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.189
91683025|NCT00492024|183255980|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.075
91683026|NCT00926783|183256011|SUPERIORITY_OR_OTHER|||||||0.048||||||The p-value was based on Fisher's exact test. There were no adjustments for multiple comparisons.|Fisher Exact|||The null hypothesis is that rates of free from atrial arrhythmia for the two arms, Targeted and Generalized, are the same. The alternative hypothesis is that the rates are not the same. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.048
91683027|NCT00926783|183256012|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the total RF delivery times for both arms are equal. The alternative hypothesis is that the total RF delivery times are not equal. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.002
91683028|NCT00696787|183256030|SUPERIORITY_OR_OTHER||Adjusted mean|-0.38||||0.471|TWO_SIDED|95.0|-1.42|0.66|||ANCOVA|||||0.66|-1.42|0.471
91683029|NCT00696787|183256030|SUPERIORITY_OR_OTHER||Adjusted mean|-0.28||||0.604|TWO_SIDED|95.0|-1.33|0.77|||ANCOVA|||||0.77|-1.33|0.604
91683030|NCT00696787|183256031|SUPERIORITY_OR_OTHER||Adjusted mean|-0.35||||0.51|TWO_SIDED|95.0|-1.42|0.71|||ANCOVA|||||0.71|-1.42|0.510
91683031|NCT00696787|183256031|SUPERIORITY_OR_OTHER||Adjusted mean|-0.55||||0.317|TWO_SIDED|95.0|-1.64|0.54|||ANCOVA|||||0.54|-1.64|0.317
91683032|NCT02704403|183256040|SUPERIORITY||Mean Difference (Net)|0.043||||0.0659|TWO_SIDED|95.0|-0.003|0.09|||Regression, Logistic|test is 2-sided, alpha=0.01||The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.||0.090|-0.003|0.0659
91683033|NCT02704403|183256041|SUPERIORITY||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.619|1.457|||||No formal test due to the early termination of the study.|||1.457|0.619|
91683034|NCT02922738|183256080|SUPERIORITY||Cox Proportional Hazard|0.92||||0.54|TWO_SIDED|95.0|0.7|1.21|||Regression, Cox|||||1.21|0.70|0.54
91683035|NCT02922738|183256081|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91683036|NCT01346293|183256096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were \> -10%.|Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.7|10.2||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||10.2|0.7|
91683037|NCT01346293|183256096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were \> -10%.|Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|2.5|21.5||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||21.5|2.5|
91683038|NCT01346293|183256096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were \> -10%.|Mean Difference (Final Values)|3.7|||||TWO_SIDED|3.7|-0.2|7.9||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||7.9|-0.2|
91683039|NCT01346293|183256096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were \> -10%.|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|0.9|9.1||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||9.1|0.9|
91683040|NCT01346293|183256097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.68|2.31||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.||2.31|1.68|
91683041|NCT01346293|183256097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.3|1.88||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.88|1.30|
91683042|NCT01346293|183256097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.51|||||TWO_SIDED|95.0|1.27|1.79||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.79|1.27|
91683043|NCT01346293|183256097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.33|||||TWO_SIDED|95.0|1.12|1.6||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.60|1.12|
91683044|NCT02687217|183256120|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91683045|NCT02687217|183256121|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
91683046|NCT02687217|183256122|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
91683047|NCT01844505|183256123|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|99.5|0.43|0.76|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.|||0.76|0.43|<0.0001
91683048|NCT01844505|183256123|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|99.5|0.31|0.57|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.57|0.31|<0.0001
91683049|NCT01844505|183256124|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|98.0|0.5|0.78|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).|Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab|||0.78|0.50|<0.0001
91683050|NCT01844505|183256124|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|98.0|0.42|0.72|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.|Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.72|0.42|<0.0001
91683051|NCT01844505|183256127|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.65|0.96|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||0.96|0.65|
91683052|NCT01844505|183256128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.05|0.69|
91683053|NCT01844505|183256129|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.49|5.16|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.|||5.16|2.49|<0.0001
91683054|NCT01844505|183256129|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.35|||<|0.0001|TWO_SIDED|95.0|4.38|9.22|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.|||9.22|4.38|<0.0001
91683055|NCT01844505|183256129|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|26.0|||||TWO_SIDED|95.0|19.1|32.8|||||Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.|||32.8|19.1|
91683056|NCT01844505|183256129|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|39.0|||||TWO_SIDED|95.0|32.2|45.9|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.|||45.9|32.2|
91683057|NCT01844505|183256129|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.26|2.42|||||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab|||2.42|1.26|
91683058|NCT01844505|183256129|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|13.2|||||TWO_SIDED|95.0|5.7|20.7|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.|||20.7|5.7|
91683059|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.46|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.85|0.46|
91683060|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.28|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.54|0.28|
91683061|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.45|0.87|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||0.87|0.45|
91683062|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.34|0.59|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.59|0.34|
91683063|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.3|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.53|0.30|
91683064|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.21|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.21|0.66|
91683065|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.45|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.71|0.45|
91683066|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.33|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.53|0.33|
91683067|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.57|0.94|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||0.94|0.57|
91683068|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.27|0.6|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.60|0.27|
91683069|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.22|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.54|0.22|
91683070|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.54|1.38|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.38|0.54|
91683071|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.67|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.67|0.43|
91683072|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.54|0.34|
91683073|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.63|1.01|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.01|0.63|
91683074|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.28|0.73|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.73|0.28|
91683075|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.16|0.49|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.49|0.16|
91683076|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.34|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.09|0.34|
91683077|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.49|1.52|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.52|0.49|
91683078|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.3|0.89|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.89|0.30|
91683079|NCT01844505|183256130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.33|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.09|0.33|
91683080|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.57|1.05|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||1.05|0.57|
91683081|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.43|0.81|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.81|0.43|
91683082|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||||95.0|0.55|1.04|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||1.04|0.55|
91683083|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.39|0.68|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.68|0.39|
91683084|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.38|0.67|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.67|0.38|
91683085|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.72|1.31|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.31|0.72|
91683086|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.49|0.78|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.78|0.49|
91683087|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.41|0.66|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.66|0.41|
91683088|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.66|1.08|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||1.08|0.66|
91683089|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.41|0.91|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.41|
91683090|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.38|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.38|
91683091|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.62|1.53|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.53|0.62|
91683092|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.48|0.75|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.75|0.48|
91683093|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.68|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.68|0.43|
91683094|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.71|1.14|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.14|0.71|
91683095|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.44|1.1|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||1.10|0.44|
91683096|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.32|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.91|0.32|
91683097|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.45|1.32|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.32|0.45|
91683098|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.37|1.34|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.34|0.37|
91683099|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.26|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.91|0.26|
91683100|NCT01844505|183256131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.34|1.39|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.39|0.34|
91683101|NCT02730351|183256148|OTHER||Mean Difference (Final Values)|-1.69||||0.109|TWO_SIDED|95.0|-3.76|0.39||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.39|-3.76|0.109
91683102|NCT02730351|183256149|OTHER||Mean Difference (Final Values)|-2.15||||0.051|TWO_SIDED|95.0|-4.31|0.01||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.01|-4.31|0.051
91683103|NCT02730351|183256150|OTHER||Odds Ratio (OR)|1.34||||0.266|TWO_SIDED|95.0|0.8|2.26||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method. Covariates of treatment, sex, age, treatment period, and period baseline FEV1 were included.|Regression, Logistic||12 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.26|0.80|0.266
91683104|NCT02730351|183256150|OTHER||Odds Ratio (OR)|1.37||||0.322|TWO_SIDED|95.0|0.73|2.58||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method|Regression, Logistic||23 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.58|0.73|0.322
91683105|NCT02730351|183256151|OTHER||Mean Difference (Final Values)|-0.65||||0.342|TWO_SIDED|95.0|-2.01|0.71||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||12 hrs post-dose|||0.71|-2.01|0.342
91683106|NCT02730351|183256151|OTHER||Mean Difference (Final Values)|-1.75||||0.041|TWO_SIDED|95.0|-3.42|-0.07||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values.|Mixed Models Analysis||23 hrs post-dose|||-0.07|-3.42|0.041
91683107|NCT00311402|183256152|NON_INFERIORITY_OR_EQUIVALENCE|The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.|Cox Proportional Hazard|1.47||||0.097||95.0|0.93|2.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.31|0.93|0.097
91683108|NCT00311402|183256153|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.79||||0.223||95.0|0.7|4.54|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||4.54|0.70|0.223
91683109|NCT00311402|183256154|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.0||||0.998|ONE_SIDED|95.0|0.0||||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|||0|0.998
91487352|NCT04195906|182847256|SUPERIORITY||Difference in slopes between arms|0.57|STANDARD_ERROR_OF_MEAN|0.68||0.406|TWO_SIDED|95.0|-0.79|1.93||MMRM model includes fixed effect terms for randomized treatment, continuous variables maintenance opioid dose, Week (1 to 12) and Week by randomized treatment interaction. The random coefficients are the intercept and Week as a continuous variable.|MMRM|MMRM: mixed model repeated measures. An unstructured variance-covariance matrix is used||||1.93|-0.79|0.406
91683110|NCT00311402|183256155|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.977||95.0|0.21|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.21|0.977
91683111|NCT00311402|183256156|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58||||0.192||95.0|0.26|1.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.31|0.26|0.192
91683112|NCT00311402|183256157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.88||||0.215||95.0|0.69|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.69|0.215
91683113|NCT00311402|183256158|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.16||||0.443||95.0|0.79|1.69|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.69|0.79|0.443
91683114|NCT00311402|183256159|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.52||||0.043||95.0|1.01|2.29|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.29|1.01|0.043
91683115|NCT00311402|183256160|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.919||95.0|0.48|2.25|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.25|0.48|0.919
91683116|NCT00311402|183256161|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.34||||0.101||95.0|0.94|1.91|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.91|0.94|0.101
91683117|NCT02640053|183256162|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91683118|NCT02640053|183256163|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91683119|NCT02640053|183256164|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91487353|NCT02024529|182847268|SUPERIORITY|||||||0.97||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.97
91487354|NCT02024529|182847269|SUPERIORITY|||||||0.75||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.75
91487355|NCT02024529|182847270|SUPERIORITY|||||||0.18|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.18
91487356|NCT02024529|182847271|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.81
91683120|NCT02640053|183256165|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91683121|NCT02640053|183256166|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91683122|NCT02640053|183256167|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91683123|NCT02640053|183256168|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
91683124|NCT02640053|183256169|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
91683125|NCT01798316|183256184|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91683126|NCT06281171|183256212|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
91683127|NCT06281171|183256213|SUPERIORITY|||||||0.996|||||||t-test, 2 sided|||||||.996
91683128|NCT06281171|183256214|SUPERIORITY|||||||0.782|||||||t-test, 2 sided|||||||.782
91683129|NCT06281171|183256215|SUPERIORITY|||||||0.54|||||||Regression, Linear|||||||0.54
91683130|NCT06281171|183256216|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
91683131|NCT06281171|183256217|SUPERIORITY|||||||0.3|||||||Regression, Linear|||||||0.30
91683132|NCT06281171|183256218|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
91683133|NCT00513682|183256221|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||t-test, 1 sided|||||||0.0013
91683134|NCT00513682|183256222|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 1 sided|||||||0.0009
91683135|NCT03258853|183256225|SUPERIORITY|||||||0.001|||||||paired 2-sided t-test|||||||0.001
91683136|NCT03258853|183256226|SUPERIORITY|||||||1||||||Secondary outcomes were adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
91683137|NCT03258853|183256227|SUPERIORITY|||||||0.04||||||Secondary outcomes are adjusted for multiple comparisons|paired 2-sided t-test|||||||0.04
91683138|NCT03258853|183256228|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wicoxon signed rank test|||||||1.0
91683139|NCT03258853|183256229|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
91683140|NCT03258853|183256230|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
91683141|NCT03258853|183256231|SUPERIORITY|||||||0.14||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.14
91683142|NCT03258853|183256232|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
91683143|NCT03258853|183256233|SUPERIORITY|||||||0.01|||||||Wilcoxon signed rank test|||||||0.01
91683144|NCT03258853|183256234|SUPERIORITY|||||||0.08|||||||McNemar|||||||0.08
91683145|NCT03258853|183256235|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
91683146|NCT03258853|183256236|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
91683147|NCT03258853|183256237|SUPERIORITY|||||||0.15|||||||McNemar|||||||0.15
91683148|NCT00070499|183256238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Fisher Exact|||||||0.073
91683149|NCT00070499|183256238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Fisher Exact|||||||0.31
91683150|NCT00070499|183256240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of overall survival||||0.29
91683151|NCT00070499|183256240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Log Rank|||Log-rank test of overall survival||||0.55
91683152|NCT00070499|183256241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.074
91683153|NCT00070499|183256241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.29
91718834|NCT02717195|183330425|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.9196|TWO_SIDED|95.0|-2.37|2.13||Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.13|-2.37|0.9196
91683154|NCT04036799|183256246|OTHER|Categorical variables were summarized using frequencies and proportions.|Cumulative proportion of events at 5 yrs|9.1|||||TWO_SIDED|95.0||||||||||||
91718835|NCT02717195|183330425|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.1474|TWO_SIDED|95.0|-0.59|3.94||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||3.94|-0.59|0.1474
91718836|NCT02717195|183330426|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.2998|TWO_SIDED|95.0|-0.86|2.78||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.78|-0.86|0.2998
91718837|NCT02717195|183330426|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.4478|TWO_SIDED|95.0|-2.54|1.12||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||1.12|-2.54|0.4478
91487357|NCT02642029|182847276|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexiTBS interact|-0.099|STANDARD_ERROR_OF_MEAN|0.051||0.51|TWO_SIDED|95.0|-0.1989|0.0002||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the iTBS (vs. sham) x time interaction.||.0002|-.1989|0.51
91526878|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.859|TWO_SIDED|95.0|-0.52|0.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.43|-0.52|0.859
91527623|NCT01976364|182930481|OTHER||LS mean difference|0.77|||||TWO_SIDED|95.0|-2.64|4.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.18|-2.64|
91683155|NCT04240392|183256247|SUPERIORITY||Odds Ratio (OR)|1.369||||0.534|TWO_SIDED|95.0|0.462|4.055|||Mixed Models Analysis|Generalized Linear Mixed Model||||4.055|0.462|0.5340
91683156|NCT04240392|183256248|SUPERIORITY||Odds Ratio (OR)|0.803||||0.6|TWO_SIDED|95.0|0.326|1.979|||Mixed Models Analysis|Generalized Linear Mixed Model||At delivery||1.979|0.326|0.600
91683157|NCT04240392|183256248|SUPERIORITY||Odds Ratio (OR)|0.709||||0.471|TWO_SIDED|95.0|0.254|1.975|||Mixed Models Analysis|Generalized Linear Mixed Model||At 3 months post partum||1.975|0.254|0.471
91718838|NCT01773928|183330457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The probability that the modified process is noninferior to the current one (i.e. lower limit of the 95% CI of the ratio of geometric means \[modified vs. current\] is greater than or equal to 0.67) is above 99% for one strain, and it is around 97% for all three strains (considering the three strains to be independent, 0.99 x 0.99 x 0.99=0.97)|ANCOVA|0.67|||||ONE_SIDED|95.0|0.67||||||||||0.67|
91683158|NCT04240392|183256249|SUPERIORITY||Beta-coefficient|1.53||||0.518|TWO_SIDED|95.0|-3.13|6.19|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At week 36||6.19|-3.13|0.518
91683159|NCT04240392|183256249|SUPERIORITY||Beta-coefficient|0.32||||0.893|TWO_SIDED|95.0|-4.41|5.06|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At 3 months post partum||5.06|-4.41|0.893
91683160|NCT03785600|183256250|OTHER||||||<|0.02||||||a priori threshold is \<0.05.|t-test, 2 sided|||||||<0.02
91683161|NCT04086407|183256268|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
91683162|NCT04086407|183256269|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
91683163|NCT04086407|183256270|OTHER||||||||||||||||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||
91683164|NCT04086407|183256271|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
91718839|NCT01773928|183330459|SUPERIORITY_OR_OTHER_LEGACY||ANCOVA|0.67|||||TWO_SIDED|95.0|0.67|1.5||||||"The overall power to prove the similarity between the three lots for all three strains is approximately 99%.~For the two primary co-analyses (Noninferiority and Lot Consistency), the overall power of the immunogenicity analyses is approximately 96% (calculated as 0.97 x 0.99=0.96)."||1.5|0.67|
91718840|NCT01773928|183330460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Differences between fever incidences (95% CI) between treatment groups VCIV Modified (Total) and TIV was computed for each age cohort separately. The Confidence Interval estimation method was the method of Miettinen \& Nurminen, as described in the StatXact User Manual (i.e. the score statistics, also called Chan's method, page 283).~Noninferiority will be concluded if the upper limit of the 95% CI (VCIV modified-TIV) is \<5%."|Method of Miettinen & Nurminen|1.8||||||95.0|0.1|3.3||||||||3.3|0.1|
91718841|NCT01149655|183330466|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.461||||0.0161|TWO_SIDED|95.0|0.242|0.879|||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.|Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio \< 1 is in favor of oral aripiprazole 10-30 mg group for superiority test.|The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||0.879|0.242|0.0161
91718842|NCT01149655|183330468|SUPERIORITY_OR_OTHER|||||||0.0962|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0962
91718843|NCT01149655|183330469|SUPERIORITY_OR_OTHER|||||||0.9025|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9025
91718844|NCT01149655|183330470|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Log Rank|p-value was derived from the log-rank tests.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
91718845|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.3862|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis at Baseline. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3862
91718846|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.8861|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 1. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8861
91718847|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.8189|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 2. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8189
91718848|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.3689|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 3. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3689
91526879|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.386|TWO_SIDED|95.0|-0.33|0.84||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.84|-0.33|0.386
91718849|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.9723|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 4. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9723
91718850|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.2985|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 6. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.2985
91718851|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 8. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0883
91718852|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 10. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0228
91718853|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 12. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0274
91683165|NCT00660907|183256272|NON_INFERIORITY_OR_EQUIVALENCE|non-inferior margin delta = 0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0569|<|0.0001|TWO_SIDED|95.0|-0.11|0.11||Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||The null hypothesis is given as H0: mean(treat) minus mean(reference) \>= delta versus the alternative HA: mean(treat) minus mean(reference) \< delta (with alpha = 0.025, one-sided)||0.11|-0.11|<0.0001
91683166|NCT00660907|183256273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65|STANDARD_ERROR_OF_MEAN|0.2483|<|0.0001|TWO_SIDED|95.0|-5.14|-4.17||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0||-4.17|-5.14|<0.0001
91718854|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0135|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 14. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0135
91683167|NCT00660907|183256274|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-37.2|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|-42.3|-32.2||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||-32.2|-42.3|<0.0001
91683168|NCT00660907|183256275|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.8|STANDARD_ERROR_OF_MEAN|2.48|<|0.0001|TWO_SIDED|95.0|26.0|35.7||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||35.7|26.0|<0.0001
91718855|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 16. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0059
91718856|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 18. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
91718857|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 20. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0065
91718858|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 22. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0175
91718859|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 24. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0107
91718860|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0118|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 26. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0118
91718861|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 28. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0232
91718862|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 30. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0337
91718863|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 32. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0507
91683169|NCT01908907|183256276|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.07|TWO_SIDED|95.0|0.2|28.7|||Regression, Linear|Outcome was transformed using a natural logarithm transformation. Models included gestational age group since the randomization was blocked.|Since analyzed on the log scale, estimates provide are % change rather than absolute change between group.|All analyses used the intent-to-treat study population. A linear mixed model was used to assess differences in time to full feeds, days on study drug, and gestational age at discharge. These models included a random effect for multiples, which was maintained in the model after testing. Fixed effects included treatment and GA group for time to full feeds and days on study drug and treatment effect for gestational age at discharge.||28.7|0.2|0.07
91683170|NCT01908907|183256277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.008||0.048|TWO_SIDED||||||Regression, Linear|This is a complex regression model including linear and quadratic growth and interactions as specified above.||Linear mixed models were used to explore growth over time (weight, length and head circumference). These models included a random effect for intercepts and slopes to account for subject specific growth over time as well as a random effect for possible correlation between twins and triplets present in the data set. Fixed effects included both a linear and quadratic time effect, GA at birth, treatment group, full feeds (yes/no), and interactions. Non-significant interactions were eliminated.||||0.048
91683171|NCT04684238|183256291|OTHER|Least square means of the difference between the treatment groups, including a 2-sided 95% confidence interval was reported in the statistical analysis. The noninferiority criterion was a relative difference of less than 15% between treatment groups.|Least square means|6.57|||||TWO_SIDED|95.0|-8.99|22.13||Noninferiority was defined as the entire 95% CI for the difference being above the noninferiority margin for the relative difference of -15%. Testing the hypothesis of no difference between isoflurane and midazolam.|Mixed Models Analysis|||||22.13|-8.99|
91683172|NCT04684238|183256292|NON_INFERIORITY|The non-inferiority margin was set to a relative difference of -15%.|Least square means|5.34|||||TWO_SIDED|95.0|-10.48|21.17||Testing the hypothesis of no difference between isoflurane and midazolam.||||||21.17|-10.48|
91683173|NCT04684238|183256293|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0004|TWO_SIDED|95.0|-3.8|-1.1|||ANCOVA|||||-1.1|-3.8|0.0004
91683174|NCT04684238|183256294|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on an analysis of variance model with treatment group as fixed effect and baseline opioid dose as covariate.|Mean Difference (Final Values)|-0.77||||0.096|TWO_SIDED|95.0|-1.69|0.14|||ANCOVA|||||0.14|-1.69|0.096
91683175|NCT04684238|183256295|SUPERIORITY||Hazard Ratio (HR)|3.3||||0.0021|TWO_SIDED|95.0|1.54|7.07|||Regression, Cox|||Time to extubation||7.07|1.54|0.0021
91683176|NCT04684238|183256296|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.636|TWO_SIDED|95.0|-0.15|0.25|||ANOVA|||Spontaneous breathing efforts. Results display a comparison between isoflurane and midazolam and are based on a mixed effects analysis of variance model with treatment group as fixed effect.||0.25|-0.15|0.636
91683177|NCT04684238|183256297|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on a Wilcoxon ranksum test.||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at ≤24 hours.||||0.55
91683178|NCT04684238|183256297|SUPERIORITY|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at \>24 hours.||||0.637
91683179|NCT02152605|183256328|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.03|||<|0.001|TWO_SIDED|95.0|-6.28|-1.79|||Mixed Models Analysis|||||-1.79|-6.28|<0.001
91683180|NCT02152605|183256329|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.122|||<|0.001|TWO_SIDED|95.0|0.071|0.172|||Mixed Models Analysis|||||0.172|0.071|<0.001
91683181|NCT02152605|183256330|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
91683182|NCT00537303|183256335|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set|Mean Difference (Final Values)|0.06||||0.606||95.0|-0.17|0.29||P-value for test of difference between treatments.|ANCOVA|Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.29|-0.17|0.606
91683183|NCT00537303|183256336|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.|Mean Difference (Final Values)|0.03||||0.816||95.0|-0.21|0.26||P-value for test of difference between treatments.|ANCOVA|||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.26|-0.21|0.816
91683184|NCT01473524|183256344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
91683185|NCT01473524|183256346|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
91683186|NCT01473524|183256347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
91683187|NCT01473524|183256348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
91683188|NCT01473524|183256349|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683189|NCT01473524|183256349|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683190|NCT01473524|183256350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0004
91683191|NCT01473524|183256350|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683192|NCT01473524|183256351|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683193|NCT01473524|183256351|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683194|NCT01473524|183256352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683195|NCT01473524|183256352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683196|NCT01473524|183256353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0003
91683197|NCT01473524|183256353|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor||||||<0.0001
91683198|NCT01473524|183256354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683199|NCT01473524|183256354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
91683200|NCT01544179|183256357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.273|TWO_SIDED|95.0|0.65|1.13|||Cox Proportional Hazards|||||1.13|0.65|0.273
91683201|NCT01544179|183256360|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.62||||0.029|TWO_SIDED|95.0|1.05|2.52|||Cox Proportional Hazards|||||2.52|1.05|0.029
91683202|NCT01544179|183256361|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.76|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||||1.55|0.55|0.760
91683203|NCT01544179|183256362|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.308|TWO_SIDED|95.0|0.74|2.62|||Regression, Logistic|||||2.62|0.74|0.308
91683204|NCT01544179|183256363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.77|TWO_SIDED|95.0|0.53|1.59|||Regression, Logistic|||||1.59|0.53|0.770
91683205|NCT01544179|183256364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.507|TWO_SIDED|95.0|0.68|1.21|||Cox Proportional Hazards|||||1.21|0.68|0.507
91683206|NCT01544179|183256365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.725|TWO_SIDED|95.0|0.54|1.53|||Regression, Logistic|||||1.53|0.54|0.725
91683207|NCT01544179|183256366|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.575|TWO_SIDED|95.0|0.69|1.23|||Cox Proportional Hazards|||||1.23|0.69|0.575
91683208|NCT01544179|183256367|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.959|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||||1.68|0.61|0.959
91683209|NCT01544179|183256368|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.437|TWO_SIDED|95.0|0.66|1.2|||Cox Proportional Hazards|||||1.20|0.66|0.437
91683210|NCT04314648|183256379|SUPERIORITY||Odds Ratio (OR)|6.26|||<|0.001|TWO_SIDED|95.0|2.38|16.48|||Regression, Logistic|||||16.48|2.38|<.001
91683211|NCT04314648|183256380|SUPERIORITY||Odds Ratio, log|5.76|||<|0.01|TWO_SIDED|95.0|1.86|17.86|||Regression, Logistic|||||17.86|1.86|<.01
91683212|NCT04314648|183256381|SUPERIORITY||Odds Ratio (OR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||2.64|.21|.64
91683213|NCT04314648|183256382|SUPERIORITY||Odds Ratio (OR)|2.67||||0.35|TWO_SIDED|95.0|0.35|20.51|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||20.51|.35|.35
91683214|NCT04314648|183256383|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.32||0.43|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a linear regression model, adjusted for baseline use.|||||.43
91683215|NCT04314648|183256384|SUPERIORITY||Mean Difference (Net)|2.35|STANDARD_ERROR_OF_MEAN|3.0||0.44|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a liner regression model, adjusted for baseline use.|||||.44
91683216|NCT04314648|183256385|SUPERIORITY||Odds Ratio (OR)|1.19||||0.77|TWO_SIDED|95.0|0.39|3.62|||Regression, Logistic|||||3.62|.39|.77
91683217|NCT04623086|183256421|OTHER|Comparison of two groups|Mean Difference (Net)|8.1||||0.14|TWO_SIDED||||||t-test, 2 sided|||For our power calculations, we assumed the true change in TIR to be 0% for the bridging group and 15% for the direct-conversion group, and we assumed a common standard deviation of 15% (meaning the distributions of change in TIR are separated by 1 standard-deviation unit), and thereby obtained that 20 patients in each group would provide 87% power to observe a statistically significant (at the two-sided level of .05) difference in mean change of TIR.||||0.14
91683218|NCT04623086|183256422|OTHER|Comparison of two groups|Mean Difference (Net)|4.1||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
91683219|NCT04623086|183256423|OTHER|Comparison of two groups|Mean Difference (Net)|12.1||||0.29|TWO_SIDED||||||t-test, 2 sided|||||||0.29
91683220|NCT04623086|183256424|OTHER|Comparison of two groups|Mean Difference (Net)|-11.9||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||0.015
91683221|NCT04623086|183256425|OTHER||Mean Difference (Net)|0.3||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
91683222|NCT04623086|183256426|OTHER|Comparison of two groups|Mean Difference (Net)|2.6||||0.031|TWO_SIDED||||||t-test, 2 sided|||||||0.031
91683223|NCT04623086|183256427|OTHER|Comparison of two groups|Mean Difference (Net)|1.1||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
91683224|NCT04623086|183256428|OTHER|Comparison of two groups|Mean Difference (Net)|0.0|||>|0.99|TWO_SIDED||||||t-test, 2 sided|||||||>0.99
91683225|NCT03464630|183256429|SUPERIORITY|||||||0.503||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.503
91683226|NCT03464630|183256430|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
91683227|NCT03464630|183256431|SUPERIORITY|||||||0.059||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.059
91683228|NCT03464630|183256432|SUPERIORITY|||||||0.702||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.702
91683229|NCT03464630|183256433|SUPERIORITY|||||||0.08||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.08
91683230|NCT03464630|183256434|SUPERIORITY|||||||0.09||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.09
91683231|NCT03464630|183256435|SUPERIORITY|||||||0.898||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.898
91683232|NCT03464630|183256436|SUPERIORITY|||||||0.349||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.349
91683233|NCT03464630|183256437|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
91683234|NCT00715624|183256438|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.096||0.0002|TWO_SIDED|95.0|-0.55|-0.174||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.174|-0.550|0.0002
91683235|NCT02309138|183256459|SUPERIORITY||Risk Ratio (RR)|0.903||||0.668|TWO_SIDED|97.5|0.538|1.516||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.|A relative risk \< 1 represents a benefit in the direction of the IADPSG group, while a value \> 1 represents a benefit towards the CC group.|Co-primary hypotheses #1: women diagnosed using the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those diagnosed using the Carpenter-Coustan criteria.||1.516|0.538|0.668
91683236|NCT02309138|183256459|SUPERIORITY||Risk Ratio (RR)|0.853||||0.853|TWO_SIDED|97.5|0.493|1.475||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.||"Co-primary hypothesis #2: women classified as no gestational diabetes by the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those classified in the Carpenter-Coustan criteria."||1.475|0.493|0.853
91683237|NCT02309138|183256460|SUPERIORITY||Risk Ratio (RR)|1.046||||0.6669|TWO_SIDED|95.0|0.847|1.291|||Regression, Logistic|||||1.291|0.847|0.6669
91683238|NCT02309138|183256460|SUPERIORITY||Risk Ratio (RR)|1.033||||0.8394|TWO_SIDED|95.0|0.816|1.307|||Regression, Logistic|||||1.307|0.816|0.8394
91683239|NCT02309138|183256461|SUPERIORITY||Risk Ratio (RR)|0.987||||0.9335|TWO_SIDED|95.0|0.74|1.318|||Regression, Logistic|||||1.318|0.740|0.9335
91683240|NCT02309138|183256461|SUPERIORITY||Risk Ratio (RR)|1.022||||0.926|TWO_SIDED|95.0|0.742|1.407|||Regression, Logistic|||||1.407|0.742|0.9260
91683241|NCT02309138|183256462|SUPERIORITY||Risk Ratio (RR)|1.4||||0.0322|TWO_SIDED|95.0|1.027|1.909|||Regression, Logistic|||||1.909|1.027|0.0322
91527624|NCT01976364|182930481|OTHER||LS mean difference|0.47|||||TWO_SIDED|95.0|-2.26|3.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.20|-2.26|
91683242|NCT02309138|183256462|SUPERIORITY||Risk Ratio (RR)|1.233||||0.2643|TWO_SIDED|95.0|0.864|1.76|||Regression, Logistic|||||1.760|0.864|0.2643
91683243|NCT01955083|183256477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|16.0|<|0.05|TWO_SIDED|95.0|-14.4|48.4|||Wilcoxon (Mann-Whitney)|||We hypothesized that pillar implant provide a better efficacy in the treatment of snoring than radiofrequency surgery. The sample size was estimated using the primary outcome effects (VAS) in two previously published studies (Friedman 2008; Fang 2004). Using a two-tailed Wilcoxon signed-rank test (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate, we needed at least 14 participants.||48.4|-14.4|<0.05
91683244|NCT01955083|183256478|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683245|NCT01955083|183256479|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683246|NCT01955083|183256480|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683247|NCT01955083|183256481|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683248|NCT01955083|183256482|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683249|NCT01955083|183256483|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683250|NCT01955083|183256484|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683251|NCT01955083|183256485|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683252|NCT01955083|183256486|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683253|NCT01955083|183256487|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683254|NCT01955083|183256488|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91683255|NCT01955083|183256489|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
91683256|NCT01559389|183256504|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_DEVIATION|2.5||0.16|TWO_SIDED|95.0|-1.23|0.21||P-values less than 0.05 were considered statistically significant.|t-test, 2 sided|The method was a paired t-test||The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners||0.21|-1.23|.16
91683257|NCT01559389|183256505|SUPERIORITY||z-score|2.97||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact test|The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment|The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.||||.003
91683258|NCT01559389|183256506|SUPERIORITY||z-score|0.89||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups|The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin||||.37
91683259|NCT02871492|183256507|SUPERIORITY|||||||0.4294|||||||Cochran-Mantel-Haenszel|||||||0.4294
91683260|NCT03201445|183256547|OTHER||Difference in Percentage|-7.8|||||TWO_SIDED|95.0|-16.3|0.7|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||0.7|-16.3|
91683261|NCT03201445|183256549|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1.8|-2.1|
91683262|NCT03201445|183256551|OTHER||Median Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-13.4|24.7|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||24.7|-13.4|
91683263|NCT03201445|183256553|OTHER||Median Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4.9|-2.8|
91683264|NCT03201445|183256555|OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.3|-0.1|
91683265|NCT03201445|183256557|OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|0.0|4.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4|0|
91683266|NCT00724048|183256572|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.078|TWO_SIDED|95.0|-2.47|0.13|||ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.13|-2.47|0.078
91683267|NCT00724048|183256572|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.084|TWO_SIDED|95.0|-2.53|0.16||Hypothesis testing was completed only if ACR16 45 mg BID (90 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.16|-2.53|0.084
91718864|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0791|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 34. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0791
91718865|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0898|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 36. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0898
91527625|NCT01976364|182930481|OTHER||LS mean difference|2.18|||||TWO_SIDED|95.0|-1.46|5.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.81|-1.46|
91683268|NCT00724048|183256572|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.982|TWO_SIDED|95.0|-1.35|1.32||Hypothesis testing was completed only if ACR16 22.5 mg BID (45 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||1.32|-1.35|0.982
91683269|NCT00474266|183256592|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|2.2|||||TWO_SIDED|95.0|0.29|6.78||||||||6.78|0.29|
91683270|NCT00474266|183256592|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.78|1.58||||||||1.58|-0.78|
91683271|NCT00474266|183256592|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.79|1.58||||||||1.58|-0.79|
91683272|NCT00474266|183256592|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|1.07||||||||1.07|-1.06|
91683273|NCT00474266|183256593|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.17||||||||3.17|-1.06|
91683274|NCT00474266|183256594|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|4.06|||||TWO_SIDED|95.0|-2.82|12.46||||||||12.46|-2.82|
91683275|NCT00474266|183256595|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.18||||||||3.18|-1.06|
91683276|NCT00474266|183256596|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|3.36|||||TWO_SIDED|95.0|-0.28|9.5||||||||9.5|-0.28|
91683277|NCT03316378|183256680|SUPERIORITY||Mean Difference (Final Values)|73.8||||0.44|TWO_SIDED|||||Adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||0.44
91683278|NCT03316378|183256680|SUPERIORITY||Mean Difference (Final Values)|31.7||||0.08|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.08
91683279|NCT03316378|183256681|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||<0.001
91683280|NCT03316378|183256681|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.012|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.012
91683281|NCT03316378|183256682|SUPERIORITY||Mean Difference (Final Values)|0.15||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||1.0
91683282|NCT03316378|183256682|SUPERIORITY||Mean Difference (Final Values)|0.05||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||1.0
91683283|NCT01197755|183256720|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.17||||0.004|TWO_SIDED|95.0|0.05|0.28||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.28|0.05|0.004
91683284|NCT01197755|183256720|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.07||||0.168|TWO_SIDED|95.0|-0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|-0.03|0.168
91683285|NCT01197755|183256721|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.22|||<|0.001|TWO_SIDED|95.0|0.16|0.29|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.16|<0.001
91683286|NCT01197755|183256722|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.1||||0.014|TWO_SIDED|95.0|0.02|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.02|0.014
91683287|NCT01197755|183256722|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.05||||0.18|TWO_SIDED|95.0|-0.02|0.12||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.02|0.180
91683288|NCT01197755|183256723|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.12|||<|0.001|TWO_SIDED|95.0|0.06|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.06|<0.001
91683289|NCT01197755|183256723|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.0||||0.891|TWO_SIDED|95.0|-0.04|0.04||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.04|-0.04|0.891
91683290|NCT01197755|183256724|SUPERIORITY_OR_OTHER||Treatment difference|||||0.01||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.010
91683291|NCT01197755|183256724|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.019
91683292|NCT01197755|183256725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.023|TWO_SIDED|95.0|1.21|13.91|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||13.91|1.21|0.023
91683293|NCT01197755|183256725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.197|TWO_SIDED|95.0|0.65|8.23||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.23|0.65|0.197
91683294|NCT01197755|183256726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.005|TWO_SIDED|95.0|1.54|10.92|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||10.92|1.54|0.005
91683295|NCT01197755|183256726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.002|TWO_SIDED|95.0|1.79|12.3||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||12.30|1.79|0.002
91683296|NCT01197755|183256727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.86|5.76||Nominal p value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||5.76|1.86|<0.001
91683297|NCT01197755|183256727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.028|TWO_SIDED|95.0|1.07|3.31||Nominal p-value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||3.31|1.07|0.028
91683298|NCT01197755|183256728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.33|4.45|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.45|1.33|0.004
91683299|NCT01197755|183256728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.186|TWO_SIDED|95.0|0.82|2.79||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.79|0.82|0.186
91683300|NCT01197755|183256729|SUPERIORITY_OR_OTHER|||||||0.729||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.729
91683301|NCT01197755|183256729|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.019
91683302|NCT01197755|183256730|SUPERIORITY_OR_OTHER||Treatment difference|2.6||||0.009||95.0|0.65|4.56|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.56|0.65|0.009
91683303|NCT01197755|183256730|SUPERIORITY_OR_OTHER||Treatment difference|1.53||||0.118|TWO_SIDED|95.0|-0.39|3.44|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.44|-0.39|0.118
91683304|NCT01197755|183256731|SUPERIORITY_OR_OTHER||Treatment difference|0.67||||0.487||95.0|-1.23|2.58|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.58|-1.23|0.487
91683305|NCT01197755|183256731|SUPERIORITY_OR_OTHER||Treatment difference|0.62||||0.516|TWO_SIDED|95.0|-1.26|2.51|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.51|-1.26|0.516
91683306|NCT03395405|183256741|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.459|TWO_SIDED|95.0|0.33|1.64||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|Likelihood Ratio Test|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.|HR estimated from a Cox model|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||1.64|0.33|0.459
91683307|NCT03395405|183256743|SUPERIORITY|||||||0.735||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|ANCOVA|Titer values were log-transformed||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||||0.735
91683308|NCT03395405|183256747|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.873|TWO_SIDED|95.0|0.19|4.06||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Likelihood Ratio Test|||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until first negative viral load between study arms, with a two-sided alternative.||4.06|0.19|0.873
91683309|NCT04308226|183256756|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91683310|NCT04308226|183256758|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91683311|NCT05307510|183256759|SUPERIORITY|Statistical analysis is under powered. N is too low.||||||0.135||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at rest||||0.135
91683312|NCT05307510|183256759|SUPERIORITY|Statistical analysis is underpowered. N is too low||||||0.716||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at Night||||.716
91683313|NCT05307510|183256759|SUPERIORITY|Statistical Analysis underpowered. N is too small.||||||0.509||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain in use||||.509
91683314|NCT05307510|183256760|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
91683315|NCT05307510|183256761|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.635||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Palmar abduction of surgical hand||||.635
91683316|NCT05307510|183256761|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|-3.1||||0.521|TWO_SIDED|95.0|-13.6|7.4|||t-test, 2 sided|||Radial Abduction Surgical Hand||7.4|-13.6|.521
91683317|NCT05307510|183256762|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|7.42||||0.495|TWO_SIDED|95.0|-16.16|32.0|||t-test, 2 sided|||||32.0|-16.16|.495
91683318|NCT05307510|183256763|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.953||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Buttoning Buttons||||.953
91683319|NCT05307510|183256763|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.947||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Lacing and tying a shoe||||.947
91683320|NCT05307510|183256763|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.828||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Opening and closing safety pins||||.828
91683321|NCT05307510|183256763|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.169||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Managing coins||||.169
91683322|NCT05307510|183256764|SUPERIORITY|Statistical analysis underpowered. N too small.||||||0.917||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.917
91683323|NCT05307510|183256764|SUPERIORITY|Statistical analysis is underpowered. N is too small||||||0.837||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.837
91527626|NCT01976364|182930481|OTHER||LS mean difference|-0.12|||||TWO_SIDED|95.0|-3.25|3.01||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.01|-3.25|
91683324|NCT00761657|183256773|OTHER|||||||0.2073||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.2073
91683325|NCT00761657|183256773|OTHER|||||||0.0046||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0046
91683326|NCT00761657|183256773|OTHER|||||||0.086||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0860
91683327|NCT00761657|183256773|OTHER|||||||0.4005||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4005
91683328|NCT00761657|183256773|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
91683329|NCT00761657|183256773|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
91683330|NCT00761657|183256773|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
91683331|NCT00761657|183256773|OTHER||||||<|0.0001|||||||t-test, 2 sided|Threshold for significance at 0.05 level.||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
91683332|NCT00761657|183256774|OTHER|||||||0.0507||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0507
91683333|NCT00761657|183256774|OTHER|||||||0.4502||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4502
91683334|NCT00761657|183256774|OTHER|Threshold for significance at 0.05 level.||||||0.1603|||||||t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.1603
91683335|NCT00761657|183256774|OTHER|||||||0.9816||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.9816
91683336|NCT00761657|183256774|OTHER|||||||0.0139||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0139
91683337|NCT00761657|183256774|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
91683338|NCT00761657|183256774|OTHER|||||||0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0001
91718866|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 38. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
91718867|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0833|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 40. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0833
91718868|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 42. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0824
91718869|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 44. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
91683339|NCT00761657|183256774|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
91683340|NCT00618332|183256792|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||t-test, 2 sided|||||||0.372
91683341|NCT00618332|183256793|SUPERIORITY_OR_OTHER|||||||0.775||95.0|||||t-test, 2 sided|||||||0.775
91683342|NCT00618332|183256794|SUPERIORITY_OR_OTHER|||||||0.737||95.0|||||t-test, 2 sided|||||||0.737
91683343|NCT00618332|183256795|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||t-test, 2 sided|||||||0.117
91683344|NCT00618332|183256796|SUPERIORITY_OR_OTHER|||||||0.676||95.0|||||t-test, 2 sided|||||||0.676
91683345|NCT00618332|183256797|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||t-test, 2 sided|||||||0.795
91683346|NCT00618332|183256798|SUPERIORITY_OR_OTHER|||||||0.638||95.0|||||t-test, 2 sided|||||||0.638
91683347|NCT00618332|183256799|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.800
91683348|NCT00618332|183256800|SUPERIORITY_OR_OTHER|||||||0.968||95.0|||||t-test, 2 sided|||||||0.968
91683349|NCT01564537|183256821|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.742||||0.012|TWO_SIDED|95.0|0.587|0.939|||Log Rank||HR is estimated from Cox Regression.|||0.939|0.587|0.012
91526880|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.563|TWO_SIDED|95.0|-0.41|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.41|0.563
91683350|NCT01564537|183256822|SUPERIORITY||Hazard Ratio (HR)|0.939|||=|0.495|TWO_SIDED|95.0|0.784|1.125|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.125|0.784|=0.495
91683351|NCT01564537|183256823|SUPERIORITY||Hazard Ratio (HR)|0.916|||=|0.764|TWO_SIDED|95.0|0.516|1.626|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.626|0.516|=0.764
91683352|NCT01564537|183256835|SUPERIORITY||Odds Ratio (OR)|1.3|||=|0.332|TWO_SIDED|95.0|0.69|2.45||P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).|Cochran-Mantel-Haenszel||Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.|||2.45|0.69|=0.332
91683353|NCT02784444|183256885|SUPERIORITY||Odds Ratio (OR)|0.89||||0.747|TWO_SIDED|95.0|0.44|1.81||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||1.81|0.44|0.747
91683354|NCT02784444|183256885|SUPERIORITY||Odds Ratio (OR)|1.22||||0.575|TWO_SIDED|95.0|0.6|2.48||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.48|0.60|0.575
91683355|NCT02784444|183256885|SUPERIORITY||Odds Ratio (OR)|1.64||||0.158|TWO_SIDED|95.0|0.83|3.27||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.27|0.83|0.158
91718870|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0737|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 46. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0737
91683356|NCT02784444|183256886|SUPERIORITY||Odds Ratio (OR)|1.09||||0.828|TWO_SIDED|95.0|0.49|2.42||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.42|0.49|0.828
91527627|NCT01976364|182930482|OTHER||LS mean difference|-2.03|||||TWO_SIDED|95.0|-5.58|1.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.52|-5.58|
91683357|NCT02784444|183256886|SUPERIORITY||Odds Ratio (OR)|1.5||||0.299|TWO_SIDED|95.0|0.7|3.21||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.21|0.70|0.299
91683358|NCT02784444|183256886|SUPERIORITY||Odds Ratio (OR)|1.82||||0.116|TWO_SIDED|95.0|0.86|3.82||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.82|0.86|0.116
91683359|NCT02784444|183256887|SUPERIORITY||Odds Ratio (OR)|1.19||||0.657|TWO_SIDED|95.0|0.55|2.55||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.55|0.55|0.657
91683360|NCT02784444|183256887|SUPERIORITY||Odds Ratio (OR)|1.45||||0.332|TWO_SIDED|95.0|0.69|3.06||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.06|0.69|0.332
91683361|NCT02784444|183256887|SUPERIORITY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.16||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.16|0.72|0.270
91683362|NCT02784444|183256888|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.392|TWO_SIDED|95.0|-0.7|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.7|0.392
91683363|NCT02784444|183256888|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.023|TWO_SIDED|95.0|-1.1|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.1|0.023
91683364|NCT02784444|183256888|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.028|TWO_SIDED|95.0|-1.0|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.0|0.028
91683365|NCT02784444|183256889|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.224|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.224
91683366|NCT02784444|183256889|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.096|TWO_SIDED|95.0|-0.4|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.4|0.096
91683367|NCT02784444|183256889|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.007|TWO_SIDED|95.0|-0.6|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-0.6|0.007
91683368|NCT02784444|183256890|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.488|TWO_SIDED|95.0|-0.1|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.1|0.488
91683369|NCT02784444|183256890|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.291|TWO_SIDED|95.0|-0.3|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.3|0.291
91683370|NCT02784444|183256890|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.595|TWO_SIDED|95.0|-0.2|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.2|0.595
91683371|NCT02784444|183256891|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.416|TWO_SIDED|95.0|-0.4|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.4|0.416
91683372|NCT02784444|183256891|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.056|TWO_SIDED|95.0|-0.5|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.5|0.056
91683373|NCT02784444|183256891|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.220
91683374|NCT02784444|183256892|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.3|0.928
91683375|NCT02784444|183256892|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.244|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.244
91683376|NCT02784444|183256892|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.228|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.228
91683377|NCT00843479|183256919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91683378|NCT00843479|183256920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
91683379|NCT00843479|183256921|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
91683380|NCT00843479|183256922|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
91683381|NCT00843479|183256923|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
91683382|NCT00843479|183256924|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
91683383|NCT01386983|183256925|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.406||||0.0128|TWO_SIDED|95.0|1.297|8.941|||Regression, Cox|||||8.941|1.297|0.0128
91683384|NCT01386983|183256926|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Generalized linear model|Gamma distribution with log-link function was used.||||||0.0002
91683385|NCT02383810|183256938|SUPERIORITY|The overall hypothesis system was represented by the following pool of partial hypothesis systems: Hok: πGi = πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j HAk: πGi ≠πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j where πG is the probability of absence of Grade ≥2 CID for the Group. Each Ho involved 2 groups.|||||<|0.1||||||Overall alpha level 0.10 was maintained by correction for multiplicity according to Hommel's procedure.|Chi-squared|||Overall null hypothesis: All elsiglutide dose groups had equal proportion of subjects with max Grade≥2 diarrhea and this was equal to the one in the placebo group. This includes 6 individual hypotheses (i.e., 3 to compare each dose group vs. placebo and 3 to compare dose groups vs. each other). Raw p-values from Chi square tests were corrected for multiplicity according to the Hommel's procedure. Each of 6 hypotheses was then evaluated based on corrected p-value at alpha 0.10 (two-sided).||||<0.1
91683386|NCT04516759|183256965|SUPERIORITY||Risk Ratio (RR)|1.09||||0.1854|TWO_SIDED|95.0|0.9|1.32|||Chi-squared|Chi-squared test on the one-sided significance level of 2.5%||||1.32|0.9|0.1854
91683387|NCT04516759|183256966|OTHER|||||||0.0286||||||Baseline p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0286
91683388|NCT04516759|183256966|OTHER|||||||0.0786||||||Day 7 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0786
91683389|NCT04516759|183256966|OTHER|||||||0.2169||||||Day 14 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.2169
91683390|NCT04516759|183256966|OTHER|||||||0.186||||||Day 21 p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.1860
91683391|NCT04516759|183256966|OTHER|||||||0.2256||||||Study Drug Discontinuation (SDD) p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.2256
91683392|NCT04516759|183256967|OTHER|||||||0.4006||||||Increase in Diabetic Medication needed equal or more than 3 days|Fisher Exact|||||||0.4006
91683393|NCT04516759|183256967|OTHER|||||||0.7482||||||Diabetic Medication is stable/reduced equal or more than 3 days|Fisher Exact|||||||0.7482
91683394|NCT04516759|183256967|OTHER|||||||0.6949||||||Increase in Diabetic Medication needed at any time during the study|Fisher Exact|||||||0.6949
91527628|NCT01976364|182930482|OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-4.69|3.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.84|-4.69|
91683395|NCT04516759|183256967|OTHER|||||||0.5521||||||Diabetic Medication is stable/reduced at any time during the study|Fisher Exact|||||||0.5521
91683396|NCT04516759|183256968|OTHER|||||||0.5875|||||||Fisher Exact|||||||0.5875
91683397|NCT04516759|183256969|OTHER|||||||0.1129|||||||Fisher Exact|||||||0.1129
91683398|NCT04516759|183256970|SUPERIORITY|||||||0.1556|||||||Log Rank|||||||0.1556
91683399|NCT04516759|183256971|OTHER||Risk Ratio (RR)|0.41||||0.0903|TWO_SIDED|95.0|0.13|1.26|||Fisher Exact|The p-value is assessed by means of an Fisher's exact test on the one-sided significance level of 2.5%||||1.26|0.13|0.0903
91683400|NCT04516759|183256972|OTHER|||||||0.6144|||||||Fisher Exact|One-sided significance level of 2.5%||||||0.6144
91683401|NCT04516759|183256973|OTHER|||||||0.0105|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.0105
91683402|NCT04516759|183256974|OTHER|||||||0.062|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.062
91683403|NCT01338870|183256996|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.145||0.7606|TWO_SIDED|80.0|-0.08|0.29|||Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.08|0.7606
91683404|NCT01338870|183256996|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0266|TWO_SIDED|80.0|-0.46|-0.09|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.46|0.0266
91683405|NCT01338870|183256996|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.044|TWO_SIDED|80.0|-0.42|-0.06|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.06|-0.42|0.0440
91683406|NCT01338870|183256996|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.137||0.0001|TWO_SIDED|80.0|-0.71|-0.36|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.71|0.0001
91683407|NCT01338870|183256996|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.0013|TWO_SIDED|80.0|-0.6|-0.25|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.25|-0.60|0.0013
91683408|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-5.21|STANDARD_ERROR_OF_MEAN|5.7||0.3611|TWO_SIDED|95.0|-16.4|5.98|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.98|-16.40|0.3611
91683409|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-9.45|STANDARD_ERROR_OF_MEAN|5.686||0.0969|TWO_SIDED|95.0|-20.61|1.71|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.71|-20.61|0.0969
91683410|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|5.71||0.1566|TWO_SIDED|95.0|-19.3|3.11|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.11|-19.30|0.1566
91683411|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-15.92|STANDARD_ERROR_OF_MEAN|5.678||0.0052|TWO_SIDED|95.0|-27.06|-4.77|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.77|-27.06|0.0052
91683412|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-21.09|STANDARD_ERROR_OF_MEAN|5.712||0.0002|TWO_SIDED|95.0|-32.3|-9.88|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-9.88|-32.30|0.0002
91683413|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|5.852||0.9893|TWO_SIDED|95.0|-11.41|11.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.56|-11.41|0.9893
91683414|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.814||0.4767|TWO_SIDED|95.0|-15.55|7.27|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.27|-15.55|0.4767
91683415|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-2.87|STANDARD_ERROR_OF_MEAN|5.816||0.6222|TWO_SIDED|95.0|-14.28|8.55|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.55|-14.28|0.6222
91683416|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-13.88|STANDARD_ERROR_OF_MEAN|5.744||0.0159|TWO_SIDED|95.0|-25.16|-2.61|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.61|-25.16|0.0159
91683417|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-18.69|STANDARD_ERROR_OF_MEAN|5.735||0.0012|TWO_SIDED|95.0|-29.95|-7.44|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.44|-29.95|0.0012
91683418|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|3.86|STANDARD_ERROR_OF_MEAN|5.895||0.5125|TWO_SIDED|95.0|-7.71|15.43|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||15.43|-7.71|0.5125
91526881|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.56|-0.39|0.721
91683419|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|5.815||0.1455|TWO_SIDED|95.0|-19.89|2.94|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.94|-19.89|0.1455
91683420|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|5.794||0.8712|TWO_SIDED|95.0|-10.43|12.31|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.31|-10.43|0.8712
91527629|NCT01976364|182930482|OTHER||LS mean difference|1.29|||||TWO_SIDED|95.0|-3.48|6.06||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.06|-3.48|
91683421|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-19.57|STANDARD_ERROR_OF_MEAN|5.707||0.0006|TWO_SIDED|95.0|-30.77|-8.36|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.36|-30.77|0.0006
91683422|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-19.08|STANDARD_ERROR_OF_MEAN|5.696||0.0008|TWO_SIDED|95.0|-30.26|-7.9|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.90|-30.26|0.0008
91683423|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|6.99|STANDARD_ERROR_OF_MEAN|6.055||0.2488|TWO_SIDED|95.0|-4.9|18.87|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.87|-4.90|0.2488
91683424|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-7.56|STANDARD_ERROR_OF_MEAN|6.004||0.2084|TWO_SIDED|95.0|-19.34|4.23|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.23|-19.34|0.2084
91683425|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|5.971||0.9053|TWO_SIDED|95.0|-11.01|12.43|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.43|-11.01|0.9053
91683426|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.853||0.0091|TWO_SIDED|95.0|-26.79|-3.81|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.81|-26.79|0.0091
91683427|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-18.62|STANDARD_ERROR_OF_MEAN|5.875||0.0016|TWO_SIDED|95.0|-30.15|-7.09|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.09|-30.15|0.0016
91683428|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.217||0.2963|TWO_SIDED|95.0|-5.71|18.7|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.70|-5.71|0.2963
91683429|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-9.71|STANDARD_ERROR_OF_MEAN|6.17||0.1159|TWO_SIDED|95.0|-21.82|2.4|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.40|-21.82|0.1159
91683430|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|6.103||0.4413|TWO_SIDED|95.0|-7.28|16.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||16.68|-7.28|0.4413
91683431|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.918||0.0099|TWO_SIDED|95.0|-26.91|-3.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.68|-26.91|0.0099
91683432|NCT01338870|183256997|SUPERIORITY_OR_OTHER||LS mean difference|-14.95|STANDARD_ERROR_OF_MEAN|5.981||0.0126|TWO_SIDED|95.0|-26.69|-3.21|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.21|-26.69|0.0126
91683433|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.1797|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1797
91683434|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.058||0.0234|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.04|-0.19|0.0234
91683435|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.058||0.04|TWO_SIDED|80.0|-0.18|-0.03|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.18|0.0400
91683436|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.057||0.1568|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1568
91683437|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.058||0.001|TWO_SIDED|80.0|-0.25|-0.11|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.11|-0.25|0.0010
91683438|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0695|TWO_SIDED|80.0|-0.19|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.01|-0.19|0.0695
91683439|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0636|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0636
91683440|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0512|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0512
91683441|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.068||0.0051|TWO_SIDED|80.0|-0.26|-0.09|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.26|0.0051
91683442|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.069||0.0009|TWO_SIDED|80.0|-0.3|-0.13|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.30|0.0009
91683443|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.2392|TWO_SIDED|80.0|-0.19|0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.05|-0.19|0.2392
91683444|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.091||0.0308|TWO_SIDED|80.0|-0.29|-0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.05|-0.29|0.0308
91683445|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.0019|TWO_SIDED|80.0|-0.38|-0.15|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.38|0.0019
91683446|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.089||0.0034|TWO_SIDED|80.0|-0.36|-0.13|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.36|0.0034
91683447|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|80.0|-0.44|-0.21|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.44|0.0002
91718871|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0893|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 48. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0893
91718872|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0706|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 50. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0706
91718873|NCT01149655|183330473|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 52. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0657
91718874|NCT00921024|183330493|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|||||||||||||
91718875|NCT00921024|183330494|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.1|||||TWO_SIDED|||||||||||||
91718876|NCT04030598|183330503|SUPERIORITY||Percentage Difference|-90.0||||0.001|TWO_SIDED|95.0|-96.0|-76.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100 percentage (%) × (mean rate ratio -1).|||-76.00|-96.00|0.001
91718877|NCT04030598|183330504|SUPERIORITY||Percentage Difference|-89.0||||0.003|TWO_SIDED|95.0|-95.0|-77.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-77.00|-95.00|0.003
91718878|NCT04030598|183330505|SUPERIORITY||Percentage Difference|-96.0||||0.004|TWO_SIDED|95.0|-100.0|-65.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-65.00|-100.00|0.004
91718879|NCT04030598|183330506|SUPERIORITY||Risk Difference (RD)|66.7||||0.004|TWO_SIDED|95.0|17.5|95.7|||Fisher Exact|||For ≥ 50% reduction from Baseline in the HAE attack rate.||95.7|17.5|0.004
91718880|NCT04030598|183330506|SUPERIORITY||Risk Difference (RD)|75.6||||0.003|TWO_SIDED|95.0|26.8|96.5|||Fisher Exact|||For ≥ 70% reduction from Baseline in the HAE attack rate.||96.5|26.8|0.003
91718881|NCT04030598|183330506|SUPERIORITY||Risk Difference (RD)|92.3|||<|0.001|TWO_SIDED|95.0|48.0|99.8|||Fisher Exact|||For ≥ 90% reduction from Baseline in the HAE attack rate.||99.8|48.0|<0.001
91718882|NCT04030598|183330507|SUPERIORITY||Percentage Difference|-95.0||||0.009|TWO_SIDED|95.0|-99.0|-52.0|||Wald Chi-Square|||||-52.00|-99.00|0.009
91718883|NCT04030598|183330510|SUPERIORITY||Risk Difference (RD)|-14.3||||1|TWO_SIDED|95.0|-59.1|33.9|||Fisher Exact|||Week 9||33.9|-59.1|1.000
91526882|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.725|TWO_SIDED|95.0|-0.48|0.69||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.69|-0.48|0.725
91527630|NCT01976364|182930482|OTHER||LS mean difference|0.64|||||TWO_SIDED|95.0|-4.03|5.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.32|-4.03|
91718884|NCT04030598|183330510|SUPERIORITY||Risk Difference (RD)|-21.4||||0.521|TWO_SIDED|95.0|-64.9|27.1|||Fisher Exact|||Week 17||27.1|-64.9|0.521
91718885|NCT04030598|183330511|SUPERIORITY||Treatment Difference|-25.92|||||TWO_SIDED|95.0|-37.1|-14.74||||||Week 9||-14.74|-37.10|
91718886|NCT04030598|183330511|SUPERIORITY||Treatment Difference|-20.69|||||TWO_SIDED|95.0|-32.7|-8.68||||||Week 17||-8.68|-32.70|
91718887|NCT01419535|183330518|SUPERIORITY|||||||0.6|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.60
91718888|NCT01419535|183330519|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
91718889|NCT01419535|183330520|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
91718890|NCT01419535|183330521|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
91718891|NCT01419535|183330522|SUPERIORITY|||||||0.004|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.004
91718892|NCT01419535|183330523|SUPERIORITY|||||||0.002|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.002
91718893|NCT02543840|183330524|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.01|TWO_SIDED|95.0|-1.26|1.5||Adjusted for multiple comparisons (Bonferroni four comparisons).|Mixed Models Analysis|||||1.5|-1.26|<0.01
91718894|NCT02543840|183330524|SUPERIORITY||Mean Difference (Final Values)|5.03|||<|0.001|TWO_SIDED|95.0|2.24|7.82||Adjusted for comparisons (Bonferroni for 4 comparisons.)|Regression, Linear|||Among Veteran participants,we used a linear contrast comparing a) those with complex clinical presentations, defined as receiving treatment for three or more mental health diagnoses in the prior year to b) those with two or fewer diagnoses during the facilitation year from T0 to T12..||7.82|2.24|<0.001
91718895|NCT02543840|183330525|SUPERIORITY||Mean Difference (Final Values)|1.2|||<|0.04|TWO_SIDED|95.0|0.04|2.3||Adjusted for comparison (Bonferroni for four comparisons.)|Mixed Models Analysis|||||2.3|0.04|<0.04
91718896|NCT02543840|183330526|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||||0.9|-0.2|>0.05
91718897|NCT02543840|183330527|SUPERIORITY||Mean Difference (Final Values)|0.5|||>|0.05|TWO_SIDED|95.0|-1.3|2.3|||Mixed Models Analysis|||||2.3|-1.3|>0.05
91718898|NCT02543840|183330528|SUPERIORITY||Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.6|0.8|||Mixed Models Analysis|||||0.8|-0.6|>0.05
91718899|NCT02543840|183330529|SUPERIORITY||Mean Difference (Final Values)|0.005|||>|0.05|TWO_SIDED|95.0|-0.074|0.084|||t-test, 2 sided|Paired.||||0.084|-0.074|>0.05
91718900|NCT02543840|183330530|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_DEVIATION|0.206|>|0.05|TWO_SIDED|95.0|-0.056|0.077|||t-test, 2 sided|Paired.||||0.077|-0.056|>0.05
91683448|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.126||0.7854|TWO_SIDED|80.0|-0.06|0.26|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.26|-0.06|0.7854
91683449|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.123||0.0778|TWO_SIDED|80.0|-0.33|-0.02|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.33|0.0778
91683450|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.122||0.0065|TWO_SIDED|80.0|-0.46|-0.15|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.46|0.0065
91683451|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.119||0.0011|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0011
91683452|NCT01338870|183256998|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.121||0.0013|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0013
91683453|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.272||0.5636|TWO_SIDED|95.0|-0.69|0.38|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.69|0.5636
91683454|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.271||0.4889|TWO_SIDED|95.0|-0.35|0.72|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.72|-0.35|0.4889
91683455|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.272||0.5849|TWO_SIDED|95.0|-0.68|0.39|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.39|-0.68|0.5849
91683456|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.268||0.5104|TWO_SIDED|95.0|-0.7|0.35|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.70|0.5104
91683457|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.269||0.264|TWO_SIDED|95.0|-0.83|0.23|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-0.83|0.2640
91683458|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.357||0.0464|TWO_SIDED|95.0|-1.42|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-1.42|0.0464
91683459|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.353||0.7107|TWO_SIDED|95.0|-0.83|0.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.56|-0.83|0.7107
91683460|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.352||0.1564|TWO_SIDED|95.0|-1.19|0.19|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-1.19|0.1564
91683461|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.345||0.3834|TWO_SIDED|95.0|-0.98|0.38|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.98|0.3834
91683462|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.346||0.1279|TWO_SIDED|95.0|-1.21|0.15|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.15|-1.21|0.1279
91683463|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.339||0.252|TWO_SIDED|95.0|-1.06|0.28|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.28|-1.06|0.2520
91683464|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.336||0.2772|TWO_SIDED|95.0|-0.3|1.03|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.03|-0.30|0.2772
91683465|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.335||0.7038|TWO_SIDED|95.0|-0.79|0.53|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.53|-0.79|0.7038
91683466|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.329||0.2031|TWO_SIDED|95.0|-1.07|0.23|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-1.07|0.2031
91683467|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.33||0.6948|TWO_SIDED|95.0|-0.78|0.52|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.78|0.6948
91683468|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.421||0.5691|TWO_SIDED|95.0|-1.07|0.59|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.07|0.5691
91683469|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.415||0.3447|TWO_SIDED|95.0|-0.42|1.21|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.21|-0.42|0.3447
91683470|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.5769|TWO_SIDED|95.0|-1.04|0.58|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.58|-1.04|0.5769
91683471|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.402||0.3599|TWO_SIDED|95.0|-1.16|0.42|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-1.16|0.3599
91683472|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.407||0.46|TWO_SIDED|95.0|-1.1|0.5|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.50|-1.10|0.4600
91683473|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.504||0.4253|TWO_SIDED|95.0|-1.39|0.59|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.39|0.4253
91683474|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.497||0.4349|TWO_SIDED|95.0|-0.59|1.37|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.37|-0.59|0.4349
91683475|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.492||0.6697|TWO_SIDED|95.0|-1.18|0.76|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.76|-1.18|0.6697
91683476|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.476||0.5501|TWO_SIDED|95.0|-1.22|0.65|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.65|-1.22|0.5501
91683477|NCT01338870|183257000|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.484||0.4081|TWO_SIDED|95.0|-1.35|0.55|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-1.35|0.4081
91683478|NCT02288182|183257051|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.||||0.001
91683479|NCT03582826|183257066|SUPERIORITY|Paired Wilcoxon Signed-Rank Tests|Median Difference (Final Values)|79.0||||0.02|TWO_SIDED|95.0|26.0|163.0||Original p-value for dermatological bacteria was 6e-05. It was adjusted first by applying centered log-ratio (CLR) transformation approach then by false discovery rate (FDR) correction for multiple comparisons by using Benjamini-Hochberg Procedure.|Wilcoxon (Mann-Whitney)|||||163|26|0.02
91683480|NCT00574912|183257075|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91526883|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.839|TWO_SIDED|95.0|-0.52|0.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.64|-0.52|0.839
91683481|NCT01282723|183257076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0093|TWO_SIDED|95.0|1.1|1.95|||Mixed Models Analysis|||"Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®."||1.95|1.10|0.0093
91718901|NCT02543840|183330531|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.044|0.262|||t-test, 2 sided|Paired||||0.262|0.044|<0.001
91526884|NCT00474175|182929280|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.855|TWO_SIDED|95.0|-0.43|0.52||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.52|-0.43|0.855
91526885|NCT00474175|182929281|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.035|TWO_SIDED|95.0|0.01|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|0.01|0.035
91683482|NCT01282723|183257076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.3204|TWO_SIDED|95.0|0.61|1.17|||Mixed Models Analysis|||"Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®."||1.17|0.61|0.3204
91683483|NCT00469911|183257078|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91683484|NCT00371397|183257115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75||||0.009||95.0|||||Regression, Logistic|||hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.||||.009
91683485|NCT03753763|183257130|SUPERIORITY||Least square mean difference|0.1||||0.9697|TWO_SIDED|95.0|-6.3|6.5|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||6.5|-6.3|0.9697
91683486|NCT03753763|183257131|SUPERIORITY||least square mean difference|0.5||||0.7751|TWO_SIDED|95.0|-3.1|4.1||A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline.|Mixed Models Analysis|||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate||4.1|-3.1|0.7751
91683487|NCT03753763|183257132|SUPERIORITY||least square mean difference|0.2||||0.9076|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||3.7|-3.3|0.9076
91683488|NCT03753763|183257133|SUPERIORITY||least square mean difference|-1.1||||0.5386|TWO_SIDED|95.0|-4.8|2.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||2.6|-4.8|0.5386
91683489|NCT03753763|183257134|SUPERIORITY||Least square mean difference|6.0||||0.3364|TWO_SIDED|95.0|-6.5|18.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in MSA-QoL scale.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||18.6|-6.5|0.3364
91683490|NCT03753763|183257135|SUPERIORITY||Least square mean difference|0.2||||0.7574|TWO_SIDED|95.0|-1.1|1.5|||ANCOVA|||The ANCOVA included change from baseline as the response variable, treatment group as a factor, and baseline score as a covariate||1.5|-1.1|0.7574
91683491|NCT03753763|183257136|SUPERIORITY||Least square mean difference|0.8||||0.6393|TWO_SIDED|95.0|-2.5|4.0|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change from baseline in UDRS.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||4.0|-2.5|0.6393
91683492|NCT01104779|183257137|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0029|TWO_SIDED|95.0|-11.3|-2.4|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-2.4|-11.3|0.0029
91683493|NCT01104779|183257137|SUPERIORITY||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.5|-5.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-5.3|-14.5|<0.0001
91683494|NCT01104779|183257138|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0115|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-0.1|-0.6|0.0115
91683495|NCT01104779|183257138|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-0.3|-0.8|<0.0001
91683496|NCT01372774|183257154|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.63|0.35|<0.0001
91683497|NCT01372774|183257155|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7|TWO_SIDED|95.0|0.76|1.5|||Log Rank|||||1.50|0.76|0.70
91683498|NCT01372774|183257156|SUPERIORITY|||||||0.00068||||||Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Gray's K-sample|||||||0.00068
91683499|NCT01372774|183257158|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
91683500|NCT01565850|183257164|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 150 HIV-1 infected participants, randomized in a 2:1 ratio to 2 groups, would achieve 56% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 0.88 for both arms, a noninferiority margin of 0.12, and the significance level of the test at a one-sided 0.025 level were assumed.|Difference in proportions|3.3||||0.64|TWO_SIDED|95.0|-11.4|18.1||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 24; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.||18.1|-11.4|0.64
91683501|NCT01565850|183257165|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|Difference in proportions|-6.2||||0.35|TWO_SIDED|95.0|-19.9|7.4||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|||7.4|-19.9|0.35
91683502|NCT01565850|183257166|SUPERIORITY_OR_OTHER||Difference in LSM|0.04||||0.67|TWO_SIDED|95.0|-0.14|0.21||The p-value, difference in least squares mean (LSM), and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.21|-0.14|0.67
91683503|NCT01565850|183257167|SUPERIORITY_OR_OTHER||Difference in LSM|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.23|-0.11|0.50
91683504|NCT01565850|183257168|SUPERIORITY_OR_OTHER||Difference in LSM|45.0||||0.11|TWO_SIDED|95.0|-10.0|101.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||101|-10|0.11
91683505|NCT01565850|183257169|SUPERIORITY_OR_OTHER||Difference in LSM|18.0||||0.5|TWO_SIDED|95.0|-35.0|72.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||72|-35|0.50
91683506|NCT04324073|183257193|SUPERIORITY||Median posterior absolute risk differenc|0.2|||||TWO_SIDED|90.0|-11.7|12.2||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||12.2|-11.7|
91683507|NCT04324073|183257194|SUPERIORITY||Median posterior Hazard Ratio|1.1|||||TWO_SIDED|90.0|0.69|1.74||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible interval here|||1.74|0.69|
91683508|NCT04324073|183257195|SUPERIORITY||Median posterior absolute risk differenc|-7.3|||||TWO_SIDED|90.0|-22.5|8.7||Posterior probability|Bayesian analysis|Adjusted on age and centre|% Confidence Interval is %Credible Interval here. Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||8.7|-22.5|
91683509|NCT04324073|183257196|SUPERIORITY||Median posterior Hazard Ratio|1.05|||||TWO_SIDED|90.0|0.55|2.07||Posterior probability|Bayesian analysis||% Confidence Interval is % Credible Interval here|||2.07|0.55|
91683510|NCT04324073|183257197|SUPERIORITY|Day 14|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.23|2.03|||Regression, Cox|adjusted for age and sex||||2.03|0.23|
91683511|NCT04324073|183257197|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.27|1.59|||Regression, Cox|||Day 28||1.59|0.27|
91683512|NCT04324073|183257197|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.58|||Regression, Cox|||Day 90||1.58|0.31|
91683513|NCT04324073|183257197|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.4|2.25|||Regression, Cox|||Day 14||2.25|0.40|
91683514|NCT04324073|183257197|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|1.96|||Regression, Cox|||Day 28||1.96|0.40|
91683515|NCT04324073|183257197|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.35|1.58|||Regression, Cox|||Day 90||1.58|0.35|
91683516|NCT04324073|183257198|SUPERIORITY||Median posterior OR|1.11|||||TWO_SIDED|95.0|0.53|2.34|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.34|0.53|
91683517|NCT04324073|183257198|SUPERIORITY||Median posterior OR|1.02|||||TWO_SIDED|95.0|0.49|2.08|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 7||2.08|0.49|
91683518|NCT04324073|183257198|SUPERIORITY||Median posterior OR|0.79|||||TWO_SIDED|95.0|0.42|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||1.47|0.42|
91683519|NCT04324073|183257198|SUPERIORITY||Median posterior OR|0.88|||||TWO_SIDED|95.0|0.38|2.02|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.02|0.38|
91683520|NCT04324073|183257198|SUPERIORITY||Median posterior OR|1.07|||||TWO_SIDED|95.0|0.47|2.4|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||2.40|0.47|
91683521|NCT04324073|183257198|SUPERIORITY||Median posterior OR|1.13|||||TWO_SIDED|95.0|0.5|2.57|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 90||2.57|0.50|
91683522|NCT04324073|183257199|SUPERIORITY||Median Difference (Net)|-1.5|||||TWO_SIDED|95.0|-6.1|3.9||||adjusted on age and centre||||3.9|-6.1|
91683523|NCT04324073|183257200|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.72|1.57|||Fine-Gray model|adjusted for age and centre||Day 28||1.57|0.72|
91683524|NCT04324073|183257200|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.25|||Fine-Gray model|Adjusted for age and centre||Day 90||2.25|0.74|
91683525|NCT04324073|183257200|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.59|2.44|||Fine-Gray model|adjusted for age and centre||Day 28||2.44|0.59|
91683526|NCT04324073|183257200|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.74|1.55|||Fine-Gray model|Adjusted for age and centre||Day 90||1.55|0.74|
91683527|NCT04324073|183257201|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.81|1.75|||Fine-Gray model|Adjusted on age and centre||Day 28||1.75|0.81|
91683528|NCT04324073|183257201|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.8|1.67|||Fine-Gray model|Adjusted on age and centre||Day 90||1.67|0.80|
91683529|NCT04324073|183257201|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.55|2.66|||Fine-Gray model|Adjusted on age and centre||Day 28||2.66|0.55|
91683530|NCT04324073|183257201|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.71|2.37|||Fine-Gray model|Adjusted on age and centre||Day 90||2.37|0.71|
91683531|NCT04324073|183257202|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.42|1.44|||Fine-Gray model|Adjusted for age and centre||Day 28||1.44|0.42|
91683532|NCT04324073|183257202|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.49|1.47|||Fine-Gray model|adjusted for age and centre||Day 90||1.47|0.49|
91683533|NCT03610516|183257212|OTHER|A repeated measures mixed model was fitted with factors for treatment group (CFZ533 or placebo) and visit.|Ratio of geometric means CFZ533/placebo|0.579||||0.0788|TWO_SIDED|95.0|0.267|1.256||one-sided p-value|Repeated measures Mixed Model|||||1.256|0.267|0.0788
91683534|NCT02657928|183257230|SUPERIORITY|||||||0.5004|||||||Log Rank|||||||0.5004
91683535|NCT02657928|183257231|SUPERIORITY|||||||0.9127|||||||Log Rank|||||||0.9127
91683536|NCT01988129|183257237|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'sick' days||||0.66
91683537|NCT01988129|183257237|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'disability/injury' days||||0.033
91683538|NCT01988129|183257237|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)||Mixed model analysis was conducted for 'disability/injury' days||||0.003
91683539|NCT01988129|183257238|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
91683540|NCT01988129|183257239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.31|TWO_SIDED|95.0|0.6|0.98|||t-test, 2 sided||The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).|||0.98|0.60|0.31
91683541|NCT01988129|183257240|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time points||||0.22
91683542|NCT01988129|183257241|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||paired t-test|||||||0.65
91683543|NCT01988129|183257242|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||paired t-test|||||||0.71
91683544|NCT01988129|183257244|SUPERIORITY_OR_OTHER||Percentage of firefighters screened|41.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group||||
91683545|NCT01988129|183257244|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|31.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group||||
91683546|NCT01988129|183257244|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|7.7|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of insomnia; there is no comparison group||||
91683547|NCT01988129|183257244|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|3.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group||||
91683548|NCT01988129|183257244|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|9.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group||||
91683549|NCT01988129|183257245|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||paired t-test|||||||0.31
91683550|NCT01988129|183257246|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Paired t-test, 2-sided|||Sleeping while stopped in traffic||||0.16
91683551|NCT01988129|183257247|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Paired t-test, 2-sided|||||||0.46
91683552|NCT02500043|183257249|OTHER||Hazard Ratio (HR)|0.6917||||0.0003|TWO_SIDED|95.0|0.5597|0.8548||One-sided P-Value.|Log Rank|||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified Cox's proportional hazard (CPH) model and survival was summarized using Kaplan Meier estimates.||0.8548|0.5597|0.0003
91683553|NCT02500043|183257250|OTHER||Hazard Ratio (HR)|0.5723|||||TWO_SIDED|95.0|0.4674|0.7008||||||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.||0.7008|0.4674|
91683554|NCT00580788|183257258|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
91683555|NCT00580788|183257258|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
91683556|NCT00580788|183257260|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to all Arms/Groups at all time points compared to baseline|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.61
91683557|NCT00580788|183257261|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|Value The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
91683558|NCT00580788|183257262|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
91718902|NCT02543840|183330532|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.01|TWO_SIDED|95.0|0.083|0.289|||t-test, 2 sided|Paired.||||0.289|0.083|<0.01
91718903|NCT02543840|183330533|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.16|-0.07||Repeated patient binary outcome models for hospitalized (0/1) across 8 quarters.|Mixed Models Analysis|Adjusted (Bonferroni four comparisons).||||-0.07|-0.16|<0.001
91718904|NCT03114150|183330534|SUPERIORITY||Slope|-0.02|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of group, learning rate, and session.|We tested the prediction that learning rate would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.01|-.04|<.05
91718905|NCT03114150|183330535|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of exercise condition (intensity) and session.|We tested the prediction that hippocampal-cortical functional connectivity would change more for the moderate-to-vigorous acute condition compared to the light intensity condition. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.02|-.01|<.05
91718906|NCT03114150|183330536|SUPERIORITY||Mean Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom||We tested the prediction that functional connectivity strength would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.|Parameter is the interaction term for the interaction of group and session.|.02|-.03|<.05
91718907|NCT03114150|183330537|SUPERIORITY||Mean Difference (Final Values)|1.42|||<|0.05|TWO_SIDED|95.0|0.27|2.59|||Mixed Models Analysis|Residualized change model, as reported in our protocol paper.||We tested the prediction that cardiorespiratory fitness would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, as reported in our protocol paper.||2.59|.27|<.05
91718908|NCT02325414|183330543|SUPERIORITY||Median Difference (Final Values)|10.61||||0.05|TWO_SIDED||||||Mixed Models Analysis||||One-year data analysis were carried out using linear mixed-effects models. Covariate adjustments for baseline value of the corresponding outcome and ambulatory status (measured by WISCI) were performed by fitting these variables as fixed factors. The repeated measures were addressed using participant identification as random intercepts in the model.|||0.05
91718909|NCT04817189|183330547|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.05|TWO_SIDED|95.0|1.12|2.49|||generalized linear model||||"The model-based statistics were used to calculate the difference in the probability to experience a per cycle complete response between the treatment arms."|2.49|1.12|<0.05
91718910|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|0.89||||0.412|TWO_SIDED|95.0|0.68|1.17|||generalized linear model||Reference category is set to Sleep ≥ 7 h, compared to Sleep \< 7 h.|"The hypothesis states that the potential risk factor of \< 7 h of sleep the night before chemotherapy increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||1.17|0.68|0.412
91718911|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|1.14||||0.592|TWO_SIDED|95.0|0.71|1.8|||generalized linear model||Reference category is set to Without history, compared to With history.|"The hypothesis states that the potential risk factor of History of any nausea and vomiting such as motion sickness, vestibular dysfunction, … increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||1.80|0.71|0.592
91718912|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|1.15||||0.458|TWO_SIDED|95.0|0.8|1.65|||generalized linear model||Reference category is set to No anticipatory, compared to Anticipatory.|"The hypothesis states that the potential risk factor of Anticipatory nausea and/or vomiting increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||1.65|0.80|0.458
91718913|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|1.08||||0.663|TWO_SIDED|95.0|0.75|1.56|||generalized linear model||Reference category is set to No anxiety, compared to Anxiety.|"The hypothesis states that the potential risk factor of Anxiety over the past 24hrs increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||1.56|0.75|0.663
91718914|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|0.88||||0.691|TWO_SIDED|95.0|0.46|1.68|||generalized linear model||Reference category is set to \< 10 units per week, compared to \>= 10 units per week.|"The hypothesis states that the potential risk factor of Alcohol intake (\>= 10 units per week vs \< 10 units per week) increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratio."||1.68|0.46|0.691
91527631|NCT01976364|182930482|OTHER||LS mean difference|-0.13|||||TWO_SIDED|95.0|-4.64|4.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.38|-4.64|
91718915|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|1.48||||0.037|TWO_SIDED|95.0|1.02|2.14|||generalized linear model||Reference category is set to Male, compared to Female.|"The hypothesis states that the potential risk factor of Gender increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||2.14|1.02|0.037
91718916|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|1.09||||0.514|TWO_SIDED|95.0|0.84|1.42|||generalized linear model||Reference category is set to No fatigue experience, compared to Fatigue experience.|"The hypothesis states that the potential risk factor of Fatigue experience (symptom) increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||1.42|0.84|0.514
91683559|NCT00580788|183257263|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time from baseline for all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
91683560|NCT00580788|183257264|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
91683561|NCT00580788|183257264|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
91683562|NCT00580788|183257265|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
91683563|NCT00580788|183257265|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
91683564|NCT00580788|183257266|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
91683565|NCT00580788|183257266|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
91683566|NCT00580788|183257267|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.001|TWO_SIDED|||||the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.001
91683567|NCT00580788|183257267|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p=value corresponds to % change compared to baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
91683568|NCT00580788|183257268|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.05
91683569|NCT00580788|183257269|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
91683570|NCT01403051|183257270|SUPERIORITY_OR_OTHER|||||||0.001||||||2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.|Stratified Wilcoxon rank sum test|Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (\<=20 vs. \>20 ng/mL)||The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.||||0.001
91683571|NCT01701011|183257292|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
91683572|NCT01701011|183257292|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.||||<0.05
91683573|NCT01701011|183257293|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
91526886|NCT00474175|182929281|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.039|TWO_SIDED|95.0|0.0|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|-0.00|0.039
91527632|NCT01976364|182930483|OTHER||LS mean difference|-1.11|||||TWO_SIDED|95.0|-4.96|2.74||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.74|-4.96|
91683574|NCT02932306|183257294|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
91683575|NCT02932306|183257295|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
91683576|NCT02932306|183257296|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||<0.001
91683577|NCT01635218|183257327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|3.1|7.0||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.0|3.1|<0.05
91683578|NCT01635218|183257327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED|95.0|1.31|5.25||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.25|1.31|<0.05
91683579|NCT01635218|183257328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.71||0.14|TWO_SIDED|95.0|-0.73|7.61||The statistical significant ANOVA result (p\<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.61|-0.73|0.14
91683580|NCT01635218|183257328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|1.73||0.99|TWO_SIDED|95.0|-2.93|5.5||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.5|-2.93|0.99
91683581|NCT01635218|183257329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.11|||<|0.05|TWO_SIDED|95.0|0.03|0.34|||Chi-squared|||||0.34|0.03|<0.05
91683582|NCT01635218|183257329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.05|TWO_SIDED|95.0|0.06|0.56|||Chi-squared|||||0.56|0.06|<0.05
91683583|NCT01635218|183257330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.42||0.002|TWO_SIDED|95.0|2.72|14.52||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||14.52|2.72|0.002
91683584|NCT01635218|183257330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|2.37||0.424|TWO_SIDED|95.0|-2.33|9.6||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||9.6|-2.33|0.424
91683585|NCT01635218|183257331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.1||95.0|0.05|1.32|||Chi-squared|||||1.32|0.05|0.10
91683586|NCT01635218|183257331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.11|TWO_SIDED|95.0|0.05|1.39|||Chi-squared|||||1.39|0.05|0.11
91683587|NCT03262038|183257332|SUPERIORITY|||||||0.412|||||||Chi-squared|||||||.412
91683588|NCT03262038|183257333|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||.633
91683589|NCT03262038|183257334|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||.007
91683590|NCT03262038|183257335|SUPERIORITY|||||||0.634|||||||Chi-squared|||||||.634
91683591|NCT01934335|183257353|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
91683592|NCT01934335|183257354|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
91683593|NCT01934335|183257355|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
91683594|NCT00811928|183257391|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% Confidence Interval for the difference in incidence defined as (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100% (posaconazole minus fluconazole) had to be \< 4 in order to be considered non-inferior. IFI occurred: proven+probable|Difference for the incidence|-5.88|||||TWO_SIDED|95.0|-12.21|0.25|||||Posaconazole minus fluconazole|||0.25|-12.21|
91683595|NCT00811928|183257392|SUPERIORITY_OR_OTHER||Percentage of Participants|4.27|||||TWO_SIDED|95.0|1.4|9.7|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||9.7|1.4|
91683596|NCT00811928|183257392|SUPERIORITY_OR_OTHER||Percentage of Participants|13.68|||||TWO_SIDED|95.0|8.0|21.3|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||21.3|8.0|
91683597|NCT00811928|183257395|SUPERIORITY_OR_OTHER||Percentage of Participants|31.62|||||TWO_SIDED|95.0|23.3|40.9|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%.|||40.9|23.3|
91683598|NCT00811928|183257395|SUPERIORITY_OR_OTHER||Percentage of Participants|41.88|||||TWO_SIDED|95.0|32.8|51.4|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||51.4|32.8|
91683599|NCT00811928|183257396|SUPERIORITY_OR_OTHER||Percentage of Participants|2.56|||||TWO_SIDED|95.0|0.5|7.3|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||7.3|0.5|
91683600|NCT00811928|183257396|SUPERIORITY_OR_OTHER||Percentage of Participants|5.98|||||TWO_SIDED|95.0|2.4|11.9|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||11.9|2.4|
91683601|NCT00838435|183257404|OTHER|Coefficient estimates from a random coefficient model and associated p-values.|Slope|-0.5768|||||TWO_SIDED|95.0|-1.6004|0.4468|||||The slope shown above is based on a 2-year window.|A random coefficient model was used to calculate the slope (per year) of FSIQ over the entire study period. Factors in the model included visit and testing sequence, with change in FSIQ score as the dependent variable. Random terms include both intercept and visit. The treatment was considered successful if the lower 95% confidence limit of the mean change excluded a decline of greater than 5 points over a 2-year window.||0.4468|-1.6004|
91683602|NCT02348723|183257414|SUPERIORITY_OR_OTHER||Risk Difference (RD) %|-5.3||||0.0009|TWO_SIDED|95.0|-8.4|-2.2|||Chi-squared|||The risk difference between dabigatran etexilate vs. warfarin, its 2-sided 95% CI, and corresponding p-value are presented.||-2.2|-8.4|0.0009
91683603|NCT00678886|183257418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.813|TWO_SIDED|95.0|-0.06|0.08|||Mixed effects repeated measures model|||Mixed meal-stimulated C-peptide AUC, Placebo Vs Otelixizumab at Month 12||0.08|-0.06|0.813
91683604|NCT00678886|183257419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.737|TWO_SIDED|95.0|0.47|1.7|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Week 12||1.70|0.47|0.737
91683605|NCT00678886|183257419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.737|TWO_SIDED|95.0|0.42|1.39|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 6||1.39|0.42|0.737
91683606|NCT00678886|183257419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.481|TWO_SIDED|95.0|0.45|1.46|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 12||1.46|0.45|0.481
91683607|NCT00678886|183257420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.281|TWO_SIDED|95.0|-0.07|0.01|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Week 12||0.01|-0.07|0.281
91683608|NCT00678886|183257420|SUPERIORITY||Mean Difference (Net)|0.0||||0.969|TWO_SIDED|95.0|-0.05|0.05|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 6||0.05|-0.05|0.969
91683609|NCT00678886|183257420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.272|TWO_SIDED|95.0|-0.08|0.02|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 12||0.02|-0.08|0.272
91683610|NCT00678886|183257421|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18||||0.289|TWO_SIDED|95.0|-0.16|0.52|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 12||0.52|-0.16|0.289
91683611|NCT00678886|183257421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.538|TWO_SIDED|95.0|-0.15|0.49|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 6||0.49|-0.15|0.538
91683612|NCT00678886|183257421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.538|TWO_SIDED|95.0|-0.19|0.36|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Week 12||0.36|-0.19|0.538
91683613|NCT00678886|183257430|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.12||||0.54|TWO_SIDED|95.0|-0.88|3.11|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Week 12||3.11|-0.88|0.540
91683614|NCT00678886|183257430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.546|TWO_SIDED|95.0|-1.89|3.56|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 6||3.56|-1.89|0.546
91683615|NCT00678886|183257430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.462|TWO_SIDED|95.0|-1.56|3.42|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 12||3.42|-1.56|0.462
91683616|NCT00678886|183257431|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.957
91683617|NCT00678886|183257431|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.957
91683618|NCT00678886|183257432|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.653
91683619|NCT00678886|183257432|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.653
91683620|NCT04693416|183257454|OTHER|||||||0.252|||||||t-test, 2 sided|||Pre/post scores within arm||||0.252
91683621|NCT04693416|183257455|OTHER|||||||0.546|||||||t-test, 2 sided|||Pre/post score within arm||||0.546
91683622|NCT04693416|183257456|OTHER|||||||0.005|||||||t-test, 2 sided|||Pre/post scores within arm||||0.005
91683623|NCT04693416|183257457|OTHER|||||||0.188|||||||t-test, 2 sided|||Pre/post scores within arm||||0.188
91683624|NCT04693416|183257458|OTHER|||||||0.049|||||||t-test, 2 sided|||Pre/post score within arm||||0.049
91683625|NCT04693416|183257459|OTHER|||||||0.036|||||||t-test, 2 sided|||Pre/post scores within arm||||0.036
91683626|NCT01695863|183257497|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.269|0.816|||t-test, 2 sided|||Right Colon||0.816|0.269|<0.0001
91683627|NCT01695863|183257497|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.005|TWO_SIDED|95.0|0.122|0.655|||t-test, 2 sided|||Transverse Colon||0.655|0.122|0.005
91683628|NCT01695863|183257497|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.08|TWO_SIDED|95.0|-0.029|0.484|||t-test, 2 sided|||Left Colon||0.484|-0.029|0.08
91683629|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.093|TWO_SIDED||||||t-test, 2 sided|||Calcium||||0.093
91683630|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.801|TWO_SIDED||||||t-test, 2 sided|||Glucose||||0.801
91683631|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.599|TWO_SIDED||||||t-test, 2 sided|||Blood Urea Nitrogen||||0.599
91683632|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.696|TWO_SIDED||||||t-test, 2 sided|||Creatinine||||0.696
91683633|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.042|TWO_SIDED||||||t-test, 2 sided|||Sodium||||.042
91527633|NCT01976364|182930483|OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-5.11|2.65||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.65|-5.11|
91683634|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.596|TWO_SIDED||||||t-test, 2 sided|||Potassium||||0.596
91683635|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.107|TWO_SIDED||||||t-test, 2 sided|||Chloride||||0.107
91683636|NCT01695863|183257498|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.351|TWO_SIDED||||||t-test, 2 sided|||Bicarbonate||||0.351
91683637|NCT01695863|183257499|SUPERIORITY||Mean Difference (Final Values)|-0.0438||||0.772|TWO_SIDED||||||t-test, 2 sided|||Nausea||||0.772
91683638|NCT01695863|183257499|SUPERIORITY||Mean Difference (Final Values)|-0.2821||||0.028|TWO_SIDED||||||t-test, 2 sided|||Vomiting||||0.028
91683639|NCT01695863|183257499|SUPERIORITY||Mean Difference (Final Values)|-0.2102||||0.235|TWO_SIDED||||||t-test, 2 sided|||Bloating||||0.235
91683640|NCT01695863|183257499|SUPERIORITY||Mean Difference (Final Values)|-0.0547||||0.707|TWO_SIDED||||||t-test, 2 sided|||Abdominal pain or cramping||||0.707
91683641|NCT01695863|183257499|SUPERIORITY||Mean Difference (Final Values)|-0.0269||||0.773|TWO_SIDED||||||t-test, 2 sided|||Ability to complete entire prep||||0.773
91683642|NCT01695863|183257499|SUPERIORITY||Mean Difference (Final Values)|0.0498||||0.766|TWO_SIDED||||||t-test, 2 sided|||Difficulty/Inconvenience in completing prep||||0.766
91683643|NCT01687244|183257507|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|33.3|||||TWO_SIDED|90.0|16.8|53.6||Not applicable: the primary analysis was a calculation of a confidence interval||||The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion||53.6|16.8|
91683644|NCT01687244|183257507|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|36.8|||||TWO_SIDED|90.0|18.8|58.2|||||The proportion of subjects achieving high-grade recurrence-free survival at 12 months|The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.||58.2|18.8|
91683645|NCT01330420|183257520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
91683646|NCT01330420|183257521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
91683647|NCT01330420|183257522|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
91683648|NCT01330420|183257524|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
91683649|NCT00073021|183257537|SUPERIORITY_OR_OTHER||Difference in Success Rates|12.543||||0.0357|TWO_SIDED|95.0|0.96|24.12|||Chi-squared|||It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.||24.12|0.96|0.0357
91683650|NCT00073021|183257538|SUPERIORITY_OR_OTHER||Difference Between Means|-0.5||||0.1594|TWO_SIDED|95.0|-1.28|0.21|||ANOVA|||||0.21|-1.28|0.1594
91683651|NCT00073021|183257538|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|The 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
91683652|NCT00073021|183257538|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|Teh 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
91683653|NCT00073021|183257539|SUPERIORITY_OR_OTHER||Difference in Success Rates|3.75||||0.5774|TWO_SIDED|95.0|-9.43|16.93|||Chi-squared|||||16.93|-9.43|0.5774
91683654|NCT00073021|183257540|SUPERIORITY_OR_OTHER||Difference in Success Rates|6.19||||0.2991|TWO_SIDED|95.0|-5.47|17.86|||Chi-squared|||||17.86|-5.47|0.2991
91683655|NCT00073021|183257541|SUPERIORITY_OR_OTHER||Difference in Success Rates|2.74||||0.6543|TWO_SIDED|95.0|-9.25|14.73|||Chi-squared|||||14.73|-9.25|0.6543
91683656|NCT00073021|183257542|SUPERIORITY_OR_OTHER||Difference in Success Rates|1.05||||0.8542|TWO_SIDED|95.0|-10.19|12.29|||Chi-squared|||||12.29|-10.19|0.8542
91683657|NCT00073021|183257543|SUPERIORITY_OR_OTHER||Difference in Success Rates|-0.96||||0.8859|TWO_SIDED|95.0|-14.09|12.17|||Chi-squared|||||12.17|-14.09|0.8859
91683658|NCT00073021|183257544|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.73||||0.0758|TWO_SIDED|95.0|-0.94|20.4|||Chi-squared|||||20.40|-0.94|0.0758
91683659|NCT00073021|183257545|SUPERIORITY_OR_OTHER|||||||0.8308||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8308
91683660|NCT00073021|183257545|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
91683661|NCT00073021|183257545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline.|t-test, 2 sided|||||||<0.0001
91683662|NCT00073021|183257546|SUPERIORITY_OR_OTHER|||||||0.534||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5340
91683663|NCT00073021|183257546|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
91683664|NCT00073021|183257546|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
91683665|NCT00073021|183257547|SUPERIORITY_OR_OTHER||Difference in Success Rates|11.1||||0.0966|TWO_SIDED|95.0|-1.87|24.14|||Chi-squared|||||24.14|-1.87|0.0966
91683666|NCT00073021|183257548|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.75||||0.1173|TWO_SIDED|95.0|-2.39|21.89|||Chi-squared|||||21.89|-2.39|0.1173
91683667|NCT02629354|183257591|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|113.77|||||TWO_SIDED|90.0|98.99|130.75|||ANOVA||Analysis of variance (ANOVA) with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% confidence interval (CI) was provided.||130.75|98.99|
91683668|NCT02629354|183257592|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|110.16|||||TWO_SIDED|90.0|96.32|125.97|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||125.97|96.32|
91683669|NCT02629354|183257593|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|112.69|||||TWO_SIDED|90.0|98.49|128.94|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||128.94|98.49|
91683670|NCT02629354|183257594|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.36|||||TWO_SIDED|90.0|94.61|100.19|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.19|94.61|
91683671|NCT02629354|183257595|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.47|||||TWO_SIDED|90.0|93.74|99.28|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||99.28|93.74|
91683672|NCT02629354|183257596|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.55|||||TWO_SIDED|90.0|92.57|102.8|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.80|92.57|
91683673|NCT02629354|183257597|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.57|||||TWO_SIDED|90.0|94.5|100.73|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.73|94.50|
91683674|NCT02629354|183257598|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.21|||||TWO_SIDED|90.0|92.22|102.46|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.46|92.22|
91683675|NCT02629354|183257599|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.83|||||TWO_SIDED|90.0|93.75|100.01|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.01|93.75|
91683676|NCT03982199|183257600|SUPERIORITY||Event Rate|80.0||||4e-05|TWO_SIDED|94.211|52.2|92.9|||Poisson regression|||Case Definition 1||92.9|52.2|0.00004
91683677|NCT03982199|183257600|SUPERIORITY||Event Rate|75.0||||1e-05|TWO_SIDED|94.211|50.1|88.5|||Poisson regression|||Case Definition 2||88.5|50.1|0.00001
91683678|NCT03982199|183257600|SUPERIORITY||Event Rate|69.8||||4e-05|TWO_SIDED|94.211|43.7|84.7|||Poisson regression|||Case Definition 3||84.7|43.7|0.00004
91683679|NCT03433755|183257617|SUPERIORITY||Treatment difference|-70.73|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-77.98|-63.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-63.48|-77.98|< 0.0001
91683680|NCT03433755|183257617|SUPERIORITY||Treatment difference|-69.74|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-76.51|-62.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-62.97|-76.51|< 0.0001
91683681|NCT03433755|183257618|SUPERIORITY||Treatment difference|-70.87|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-79.47|-62.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-62.27|-79.47|< 0.0001
91526887|NCT00474175|182929281|SUPERIORITY_OR_OTHER||Treatment difference|-0.01||||0.944|TWO_SIDED|95.0|-0.15|0.13||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.13|-0.15|0.944
91526888|NCT00058019|182929338|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
91526889|NCT00058019|182929339|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91526890|NCT00058019|182929341|SUPERIORITY_OR_OTHER|||||||0.695|TWO_SIDED|95.0|||||Log Rank|||||||0.695
91526891|NCT00058019|182929342|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Log Rank|||||||0.55
91527634|NCT01976364|182930483|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-3.78|5.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.69|-3.78|
91527635|NCT01976364|182930483|OTHER||LS mean difference|2.01|||||TWO_SIDED|95.0|-2.92|6.93||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.93|-2.92|
91527636|NCT01976364|182930483|OTHER||LS mean difference|0.66|||||TWO_SIDED|95.0|-4.03|5.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.35|-4.03|
91683682|NCT03433755|183257618|SUPERIORITY||Treatment difference|-65.81|STANDARD_ERROR_OF_MEAN|4.11|<|0.0001|TWO_SIDED|95.0|-73.97|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-57.66|-73.97|< 0.0001
91683683|NCT03433755|183257619|SUPERIORITY||Treatment difference|-76.5|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-86.6|-66.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-66.4|-86.6|< 0.0001
91683684|NCT03433755|183257619|SUPERIORITY||Treatment difference|-77.2|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|95.0|-87.7|-66.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-66.7|-87.7|< 0.0001
91683685|NCT03433755|183257620|SUPERIORITY||Treatment difference|-75.9|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-87.1|-64.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-64.7|-87.1|< 0.0001
91683686|NCT03433755|183257620|SUPERIORITY||Treatment difference|-73.0|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-84.1|-61.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-61.8|-84.1|< 0.0001
91683687|NCT03433755|183257621|SUPERIORITY||Treatment difference|-61.2|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-68.04|-54.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.37|-68.04|< 0.0001
91683688|NCT03433755|183257621|SUPERIORITY||Treatment difference|-62.15|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-67.97|-56.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-56.32|-67.97|< 0.0001
91683689|NCT03433755|183257622|SUPERIORITY||Treatment difference|-61.45|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-69.25|-53.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.65|-69.25|< 0.0001
91683690|NCT03433755|183257622|SUPERIORITY||Treatment difference|-56.65|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-63.66|-49.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-49.63|-63.66|< 0.0001
91683691|NCT03433755|183257623|SUPERIORITY||Treatment Difference|-56.26|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|95.0|-62.44|-50.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-50.07|-62.44|< 0.0001
91683692|NCT03433755|183257623|SUPERIORITY||Treatment Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-62.35|-51.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-51.65|-62.35|< 0.0001
91683693|NCT03433755|183257624|SUPERIORITY||Treatment difference|-55.69|STANDARD_ERROR_OF_MEAN|3.67|<|0.0001|TWO_SIDED|95.0|-62.98|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-48.41|-62.98|< 0.0001
91683694|NCT03433755|183257624|SUPERIORITY||Treatment difference|-51.21|STANDARD_ERROR_OF_MEAN|3.45|<|0.0001|TWO_SIDED|95.0|-58.06|-44.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-44.37|-58.06|< 0.0001
91683695|NCT03433755|183257625|SUPERIORITY||Treatment difference|-42.74|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-48.06|-37.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.41|-48.06|< 0.0001
91683696|NCT03433755|183257625|SUPERIORITY||Treatment difference|-44.3|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-49.02|-39.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-39.58|-49.02|< 0.0001
91683697|NCT03433755|183257626|SUPERIORITY||Treatment difference|-43.05|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001|TWO_SIDED|95.0|-49.09|-37.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.00|-49.09|< 0.0001
91683698|NCT03433755|183257626|SUPERIORITY||Treatment difference|-40.42|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-45.98|-34.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-34.87|-45.98|< 0.0001
91683699|NCT03433755|183257627|SUPERIORITY||Treatment difference|87.2|||<|0.0001|TWO_SIDED|95.0|72.6|92.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||92.8|72.6|< 0.0001
91683700|NCT03433755|183257627|SUPERIORITY||Treatment difference|91.5|||<|0.0001|TWO_SIDED|95.0|76.9|96.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||96.1|76.9|< 0.0001
91683701|NCT03433755|183257628|SUPERIORITY||Treatment difference|90.6|||<|0.0001|TWO_SIDED|95.0|76.6|95.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||95.6|76.6|< 0.0001
91683702|NCT03433755|183257628|SUPERIORITY||Treatment difference|85.7|||<|0.0001|TWO_SIDED|95.0|68.2|91.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||91.9|68.2|< 0.0001
91683703|NCT03433755|183257629|SUPERIORITY||Treatment difference|87.0|||<|0.0001|TWO_SIDED|95.0|73.3|93.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||93.0|73.3|< 0.0001
91683704|NCT03433755|183257629|SUPERIORITY||Treatment difference|88.7|||<|0.0001|TWO_SIDED|95.0|73.5|94.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||94.0|73.5|< 0.0001
91683705|NCT03433755|183257630|SUPERIORITY||Treatment difference|82.8|||<|0.0001|TWO_SIDED|95.0|67.8|90.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||90.1|67.8|< 0.0001
91683706|NCT03433755|183257630|SUPERIORITY||Treatment difference|82.7|||<|0.0001|TWO_SIDED|95.0|64.8|89.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||89.7|64.8|< 0.0001
91683707|NCT03433755|183257631|SUPERIORITY||Treatment difference|-48.45|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.78|-39.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.11|-57.78|< 0.0001
91683708|NCT03433755|183257631|SUPERIORITY||Treatment difference|-40.43|STANDARD_ERROR_OF_MEAN|4.13|<|0.0001|TWO_SIDED|95.0|-48.62|-32.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-32.24|-48.62|< 0.0001
91683709|NCT03433755|183257632|SUPERIORITY||Treatment difference|-44.7|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-54.76|-34.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-34.65|-54.76|< 0.0001
91683710|NCT03433755|183257632|SUPERIORITY||Treatment difference|-38.26|STANDARD_ERROR_OF_MEAN|5.88|<|0.0001|TWO_SIDED|95.0|-49.94|-26.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-26.59|-49.94|< 0.0001
91683711|NCT03433755|183257633|SUPERIORITY||Treatment difference|-15.09|STANDARD_ERROR_OF_MEAN|4.71||0.008|TWO_SIDED|95.0|-24.44|-5.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.75|-24.44|0.008
91683712|NCT03433755|183257633|SUPERIORITY||Treatment difference|-19.67|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-28.3|-11.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-11.05|-28.30|< 0.0001
91683713|NCT03433755|183257634|SUPERIORITY||Treatment difference|-17.56|STANDARD_ERROR_OF_MEAN|5.98||0.008|TWO_SIDED|95.0|-29.42|-5.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.69|-29.42|0.008
91683714|NCT03433755|183257634|SUPERIORITY||Treatment difference|-12.35|STANDARD_ERROR_OF_MEAN|5.38|<|0.0001|TWO_SIDED|95.0|-23.04|-1.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-1.67|-23.04|< 0.0001
91683715|NCT03433755|183257635|SUPERIORITY||Treatment difference|8.44|STANDARD_ERROR_OF_MEAN|2.56||0.008|TWO_SIDED|95.0|3.35|13.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.52|3.35|0.008
91683716|NCT03433755|183257635|SUPERIORITY||Treatment difference|6.8|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|2.1|11.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.50|2.10|0.017
91683717|NCT03433755|183257636|SUPERIORITY||Treatment difference|7.94|STANDARD_ERROR_OF_MEAN|2.91||0.008|TWO_SIDED|95.0|2.18|13.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.71|2.18|0.008
91683718|NCT03433755|183257636|SUPERIORITY||Treatment difference|6.17|STANDARD_ERROR_OF_MEAN|0.036||0.017|TWO_SIDED|95.0|0.42|11.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.92|0.42|0.017
91683719|NCT03433755|183257637|SUPERIORITY||Treatment difference|-22.96|STANDARD_ERROR_OF_MEAN|4.44||0.0002|TWO_SIDED|95.0|-33.12|-12.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-12.81|-33.12|0.0002
91683720|NCT03433755|183257637|SUPERIORITY||Treatment difference|-27.81|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|-36.6|-19.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-19.02|-36.60|< 0.0001
91683721|NCT03433755|183257638|SUPERIORITY||Treatment difference|-21.78|STANDARD_ERROR_OF_MEAN|6.32||0.0002|TWO_SIDED|95.0|-34.31|-9.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-9.25|-34.31|0.0002
91683722|NCT03433755|183257638|SUPERIORITY||Treatment difference|-15.74|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|95.0|-26.31|-5.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-5.18|-26.31|< 0.0001
91683723|NCT00826007|183257713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.09|0.18|||Regression, Logistic|||||.18|.09|<0.001
91683724|NCT01056289|183257732|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|1.16|||||TWO_SIDED|95.0|-0.51|2.83|||ANCOVA|||Difference: Placebo versus DVS SR 50 mg||2.83|-0.51|
91527637|NCT01976364|182930484|OTHER||LS mean difference|-0.1535|||||TWO_SIDED|95.0|-2.1444|1.8374||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.8374|-2.1444|
91683725|NCT01056289|183257732|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.03|2.35|||ANCOVA|||Difference: DVS SR 25 mg versus DVS SR 50 mg||2.35|-1.03|
91683726|NCT01056289|183257732|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.88|1.89|||ANCOVA|||Difference: Placebo versus DVS SR 25 mg||1.89|-0.88|
91683727|NCT01917916|183257736|OTHER||Slope|2.4386|STANDARD_ERROR_OF_MEAN|0.3417|||TWO_SIDED|95.0|1.7504|3.1267|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter Cmax, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1267|1.7504|
91683728|NCT01917916|183257737|OTHER||Slope|2.6033|STANDARD_ERROR_OF_MEAN|0.2499|||TWO_SIDED|95.0|2.0993|3.1073|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-∞, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1073|2.0993|
91683729|NCT01917916|183257738|OTHER||Slope|3.1291|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|2.3395|3.9187|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-tz, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.9187|2.3395|
91683730|NCT00270855|183257743|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)||||>0.05
91683731|NCT00270855|183257743|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)||||>0.05
91683732|NCT00270855|183257744|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683733|NCT00270855|183257744|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683734|NCT00270855|183257745|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.519|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.||||0.519
91683735|NCT00270855|183257745|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683736|NCT00270855|183257746|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.615|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||0.615
91683737|NCT00270855|183257746|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683738|NCT00270855|183257747|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683739|NCT00270855|183257747|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683740|NCT00270855|183257748|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683741|NCT00270855|183257749|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683742|NCT00270855|183257750|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683743|NCT00270855|183257751|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683744|NCT00270855|183257752|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683745|NCT00270855|183257753|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683746|NCT00270855|183257753|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91718917|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|0.75||||0.127|TWO_SIDED|95.0|0.52|1.08|||generalized linear model||Reference category is set to Non smoker, compared to Former smoker or smoker.|"The hypothesis states that the potential risk factor of Smoking status increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||1.08|0.52|0.127
91718918|NCT04817189|183330549|SUPERIORITY||Odds Ratio (OR)|0.87||||0.014|TWO_SIDED|95.0|0.77|0.97|||generalized linear model||The OR was calculated as the change in weight per 10 kg.|"The hypothesis states that the potential risk factor of Weight increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios."||0.97|0.77|0.014
91718919|NCT04817189|183330556|SUPERIORITY||Mean Difference (Net)|3.5|||<|0.05|TWO_SIDED|95.0|0.05|6.96|||generalized linear model||||"The model-based statistics were used to calculate the difference in the score per cycle between the treatment arms."|6.96|0.05|<0.05
91718920|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.06|||<|0.05|TWO_SIDED|95.0|-0.13|0.01|||generalized linear model||Number of vomiting episodes - acute phase|||0.01|-0.13|<0.05
91718921|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.31|||<|0.05|TWO_SIDED|95.0|-0.5|-0.12|||generalized linear model||Number of vomiting episodes - delayed phase|||-0.12|-0.50|<0.05
91718922|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.12|||<|0.05|TWO_SIDED|95.0|-0.21|-0.02|||generalized linear model||||Number of vomiting episodes - Day 2|-0.02|-0.21|<0.05
91718923|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.05|TWO_SIDED|95.0|-0.17|0.04|||generalized linear model||Number of vomiting episodes - Day 3|||0.04|-0.17|<0.05
91718924|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.05|||<|0.05|TWO_SIDED|95.0|-0.16|0.05|||generalized linear model||Number of vomiting episodes - Day 4|||0.05|-0.16|<0.05
91718925|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.04|||<|0.05|TWO_SIDED|95.0|-0.13|0.05|||generalized linear model||Number of vomiting episodes - Day 5|||0.05|-0.13|<0.05
91718926|NCT04817189|183330567|SUPERIORITY||Mean Difference (Net)|-0.37|||<|0.05|TWO_SIDED|95.0|-0.6|-0.14|||generalized linear model||Number of vomiting episodes - overall phase|||-0.14|-0.60|<0.05
91718927|NCT02775851|183330568|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null pCR rate of 5% and powered the study assuming an alternative hypothesis of 25%. This single stage design had an alpha of 3.4% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 90% (probability of declaring the regimen warrants further study when the true pCR is 25%) with 25 eligible participants.||||<0.001
91718928|NCT02775851|183330569|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null CR rate of 5% and powered the study assuming an alternative hypothesis of 20%. This single stage design had an alpha of 8.5% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 82% (probability of declaring the regimen warrants further study when the true CR is 20%) with 21 eligible participants.||||<0.001
91718929|NCT02058095|183330672|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91718930|NCT02058095|183330674|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91718931|NCT00148798|183330681|SUPERIORITY_OR_OTHER|||||||0.0441|TWO_SIDED|95.0|||||Stratified Log Rank|||Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).||||0.0441
91718932|NCT00148798|183330682|SUPERIORITY_OR_OTHER|||||||0.3869|TWO_SIDED|95.0|||||Stratified Log Rank|||To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).||||0.3869
91718933|NCT00148798|183330683|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.0101
91718934|NCT00148798|183330684|SUPERIORITY_OR_OTHER|||||||0.6801|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.6801
91718935|NCT02842866|183330718|NON_INFERIORITY|The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (\>) -10 percent (%) for all four serogroups.|Difference in percentage|15.7|||||TWO_SIDED|95.0|9.08|22.2||||||Serogroup A||22.2|9.08|
91718936|NCT02842866|183330718|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|27.5|||||TWO_SIDED|95.0|21.2|33.5||||||Serogroup C||33.5|21.2|
91718937|NCT02842866|183330718|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|31.0|||||TWO_SIDED|95.0|24.6|37.0||||||Serogroup Y||37.0|24.6|
91718938|NCT02842866|183330718|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|17.8|||||TWO_SIDED|95.0|11.2|24.2||||||Serogroup W||24.2|11.2|
91718939|NCT02842866|183330719|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.4|2.2||||||Serogroup A||2.20|1.40|
91718940|NCT02842866|183330719|OTHER||GMT Ratio|4.1|||||TWO_SIDED|95.0|3.16|5.33||||||Serogroup C||5.33|3.16|
91718941|NCT02842866|183330719|OTHER||GMT Ratio|3.3|||||TWO_SIDED|95.0|2.57|4.23||||||Serogroup Y||4.23|2.57|
91718942|NCT02842866|183330719|OTHER||GMT Ratio|1.81|||||TWO_SIDED|95.0|1.42|2.31||||||Serogroup W||2.31|1.42|
91718943|NCT03720119|183330727|OTHER|Analysis of Variance for repeated measurements.|day effect F|27.83||||0.0001|TWO_SIDED|||||The calculated P-Value represents the repeated measurement/Day (all times versus Day 1)|Dunnett's post-hoc test|||||||0.0001
91683747|NCT00270855|183257754|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683748|NCT00270855|183257754|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91527638|NCT01976364|182930484|OTHER||LS mean difference|-0.566|||||TWO_SIDED|95.0|-1.9054|0.7735||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7735|-1.9054|
91683749|NCT00270855|183257755|NON_INFERIORITY_OR_EQUIVALENCE|Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683750|NCT00270855|183257755|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683751|NCT00270855|183257756|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683752|NCT00270855|183257756|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683753|NCT00270855|183257757|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683754|NCT00270855|183257757|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683755|NCT00270855|183257758|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683756|NCT00270855|183257758|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683757|NCT00270855|183257759|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683758|NCT00270855|183257759|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683759|NCT00270855|183257760|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683760|NCT00270855|183257761|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683761|NCT00270855|183257762|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683762|NCT00270855|183257763|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91527639|NCT01976364|182930484|OTHER||LS mean difference|-0.7991|||||TWO_SIDED|95.0|-3.0053|1.4071||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.4071|-3.0053|
91683763|NCT00270855|183257764|OTHER|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683764|NCT00270855|183257765|NON_INFERIORITY_OR_EQUIVALENCE|We used a Mann-Whitney U test.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683765|NCT00270855|183257766|NON_INFERIORITY_OR_EQUIVALENCE|A mann-whitney u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683766|NCT00270855|183257767|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
91683767|NCT00270855|183257767|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
91683768|NCT00270855|183257768|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
91683769|NCT00324649|183257817|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0014
91683770|NCT00324649|183257818|SUPERIORITY_OR_OTHER|||||||0.9713||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9713
91683771|NCT00324649|183257819|SUPERIORITY_OR_OTHER|||||||0.9725||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9725
91683772|NCT00324649|183257820|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0078
91683773|NCT00324649|183257821|SUPERIORITY_OR_OTHER|||||||0.6984||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).||||0.6984
91683774|NCT00324649|183257822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.1165||95.0|-0.9|29.4||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.|The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.|"Null Hypothesis: treatment is not associated with the observed virologic response.~Alternative Hypothesis: treatment is associated with the observed virologic response."||29.4|-0.9|0.1165
91683775|NCT00324649|183257825|SUPERIORITY_OR_OTHER|||||||0.0789||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0789
91683776|NCT00324649|183257826|SUPERIORITY_OR_OTHER|||||||0.9633||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9633
91683777|NCT00324649|183257827|SUPERIORITY_OR_OTHER|||||||0.9686||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9686
91683778|NCT00324649|183257828|SUPERIORITY_OR_OTHER|||||||0.6638||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.6638
91683779|NCT00324649|183257829|SUPERIORITY_OR_OTHER|||||||0.2907||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.2907
91683780|NCT00324649|183257830|SUPERIORITY_OR_OTHER|||||||0.0072||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0072
91683781|NCT00324649|183257831|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0006
91683782|NCT00324649|183257832|SUPERIORITY_OR_OTHER|||||||0.1785||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.1785
91683783|NCT02618759|183257835|SUPERIORITY|||||||0.0745|||||||Cochran-Mantel-Haenszel|||||||0.0745
91683784|NCT02618759|183257836|SUPERIORITY|||||||0.231|||||||Cochran-Mantel-Haenszel|||||||0.2310
91683785|NCT02618759|183257837|SUPERIORITY|||||||0.1059|||||||Cochran-Mantel-Haenszel|||||||0.1059
91683786|NCT02618759|183257838|SUPERIORITY|||||||0.6962|||||||Cochran-Mantel-Haenszel|||||||0.6962
91683787|NCT02618759|183257839|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
91683788|NCT02618759|183257840|SUPERIORITY|||||||0.1044|||||||Cochran-Mantel-Haenszel|||||||0.1044
91683789|NCT03301649|183257844|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|1.9|||||TWO_SIDED|90.0|-3.9|7.8||||||If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||7.8|-3.9|
91683790|NCT03301649|183257845|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward \[LOCF\] method).||||<0.0001
91683791|NCT03301649|183257845|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
91683792|NCT03301649|183257846|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|0.9|||||TWO_SIDED|90.0|-2.6|4.5||||||If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||4.5|-2.6|
91683793|NCT03301649|183257847|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
91683794|NCT03301649|183257847|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
91683795|NCT03323437|183257860|OTHER|two way anova|||||<|0.01|||||||ANOVA|||||||<0.01
91683796|NCT03323437|183257861|OTHER|two way anova||||||0.68|||||||ANOVA|||||||.68
91683797|NCT03323437|183257862|OTHER|two way anova||||||0.03|||||||ANOVA|||||||.03
91683798|NCT03323437|183257863|OTHER|two way anova||||||0.01|||||||ANOVA|||||||.01
91683799|NCT03323437|183257864|OTHER|two sided t test||||||0.59|||||||t-test, 2 sided|||||||.59
91683800|NCT03323437|183257865|OTHER|two sided t test||||||0.45|||||||t-test, 2 sided|||||||.45
91683801|NCT03323437|183257866|OTHER|two way anova||||||0.32|||||||ANOVA|||||||.32
91683802|NCT03323437|183257867|OTHER|two way anova||||||0.6|||||||ANOVA|||||||.60
91683803|NCT03323437|183257868|OTHER|two way anova||||||0.34|||||||ANOVA|||||||.34
91683804|NCT03323437|183257869|OTHER|two way anova||||||0.35|||||||ANOVA|||||||.35
91683805|NCT03323437|183257870|OTHER|fisher's exact||||||0.66|||||||Fisher Exact|||||||.66
91683806|NCT03323437|183257871|OTHER|two sided t test||||||0.04|||||||t-test, 2 sided|||||||.04
91683807|NCT03323437|183257872|OTHER|fisher's exact test||||||1|||||||Fisher Exact|||||||1
91683808|NCT03257865|183257895|SUPERIORITY||Treatment difference|-1.62|||=|0.1011|TWO_SIDED|95.0|-3.56|0.32|||mixed-effect model repeated measure||"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||0.32|-3.56|=0.1011
91683809|NCT03857750|183257897|OTHER||Mean Difference (Final Values)|82.0|||<|0.001|TWO_SIDED|95.0|40.0|124.0|||t-test, 2 sided|||Comparing onset time of rocuronium||124|40|<0.001
91683810|NCT03857750|183257897|OTHER||Odds|19.48|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Mann-Whitney odd||95 % confidence interval is 7.63 to infinity|82||||<0.001
91683811|NCT03857750|183257899|OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|14.0|48.0|||t-test, 2 sided|||Comparing duration of action of rocuronium||48|14|<0.001
91683812|NCT03857750|183257899|OTHER||Odds|6.35||||0.001|TWO_SIDED||||||Wilcoxon Mann-Whitney odd||95% Confidence interval is 2.59 to infinity.|Comparing duration of action of rocuronium||||0.001
91683813|NCT02549027|183257900|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.24|||||TWO_SIDED|90.0|0.12|0.47|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.47|0.12|
91683814|NCT02549027|183257900|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.21|||||TWO_SIDED|90.0|0.1|0.41|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.41|0.10|
91683815|NCT02549027|183257900|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.15|||||TWO_SIDED|90.0|0.08|0.3|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.30|0.08|
91683816|NCT02549027|183257901|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.05|||||TWO_SIDED|90.0|0.02|0.11|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.||0.11|0.02|
91683817|NCT02549027|183257904|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.67|1.07|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||1.07|0.67|
91683818|NCT02549027|183257904|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.68|||||TWO_SIDED|90.0|0.54|0.86|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.86|0.54|
91683819|NCT02549027|183257904|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.95|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.95|0.60|
91683820|NCT02549027|183257905|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.5|0.79|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.||0.79|0.50|
91683821|NCT02549027|183257906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|90.0|-12.01|17.2|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||17.20|-12.01|
91683822|NCT02549027|183257906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.28|||||TWO_SIDED|90.0|-9.33|19.88|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||19.88|-9.33|
91683823|NCT02549027|183257906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.38|||||TWO_SIDED|90.0|-8.23|20.98|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||20.98|-8.23|
91683824|NCT02549027|183257907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|||||TWO_SIDED|90.0|-7.1|25.7|||||Difference is MK-6096 - placebo|Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed.||25.70|-7.10|
91683825|NCT00168818|183257919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-0.7||||0.5648||95.0|-2.9|1.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.6|-2.9|0.5648
91683826|NCT00168818|183257919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|1.9||||0.1339||95.0|-0.6|4.4||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.4|-0.6|0.1339
91683827|NCT00168818|183257920|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.3256||95.0|-2.5|0.8|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.8|-2.5|0.3256
91683828|NCT00168818|183257920|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.4||||0.7052||95.0|-1.5|2.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.2|-1.5|0.7052
91683829|NCT00168818|183257921|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.1863||95.0|-2.7|0.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.5|-2.7|0.1863
91683830|NCT00168818|183257921|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.702||95.0|-1.4|2.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.1|-1.4|0.7020
91683831|NCT00168818|183257922|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.3173||95.0|-3.3|1.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.1|-3.3|0.3173
91683832|NCT00168818|183257922|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.9||||0.1274||95.0|-0.5|4.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.3|-0.5|0.1274
91683833|NCT00168818|183257923|SUPERIORITY_OR_OTHER|||||||0.0694||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0694
91683834|NCT00168818|183257923|SUPERIORITY_OR_OTHER|||||||0.0212||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0212
91683835|NCT00168818|183257924|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5062
91683836|NCT00168818|183257924|SUPERIORITY_OR_OTHER|||||||0.3717||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.3717
91683837|NCT00168818|183257925|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1240
91683838|NCT00168818|183257925|SUPERIORITY_OR_OTHER|||||||0.2497||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.2497
91683839|NCT00168818|183257927|SUPERIORITY_OR_OTHER|||||||0.4352||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4352
91683840|NCT00168818|183257927|SUPERIORITY_OR_OTHER|||||||0.6037||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6037
91683841|NCT00469144|183257931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants in CR||||0.9
91683842|NCT00469144|183257931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants not in CR||||0.4
91683843|NCT00469144|183257931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants in CR||||0.7
91683844|NCT00469144|183257931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants not in CR||||0.05
91527640|NCT01976364|182930484|OTHER||LS mean difference|0.0626|||||TWO_SIDED|95.0|-1.5767|1.7018||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7018|-1.5767|
91527641|NCT01976364|182930484|OTHER||LS mean difference|0.3672|||||TWO_SIDED|95.0|-1.8107|2.545||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5450|-1.8107|
91683845|NCT01994291|183257933|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.32|STANDARD_ERROR_OF_MEAN|1.52||0.1271|TWO_SIDED|80.0|-4.27|-0.37|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.37|-4.27|0.1271
91683846|NCT01994291|183257933|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.48|STANDARD_ERROR_OF_MEAN|1.36||0.0699|TWO_SIDED|80.0|-4.24|-0.73|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.73|-4.24|0.0699
91683847|NCT01994291|183257933|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.41|STANDARD_ERROR_OF_MEAN|1.17||0.0399|TWO_SIDED|80.0|-3.91|-0.91|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.91|-3.91|0.0399
91683848|NCT01994291|183257934|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1416||||0.0218|TWO_SIDED|80.0|-0.2483|-0.0467|||Barnard test|||||-0.0467|-0.2483|0.0218
91683849|NCT01994291|183257934|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0442||||0.4209|TWO_SIDED|80.0|-0.1217|0.0261|||Barnard test.|||baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||0.0261|-0.1217|0.4209
91683850|NCT01994291|183257934|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0849||||0.0778|TWO_SIDED|80.0|-0.1516|-0.0168|||Barnard test.|||||-0.0168|-0.1516|0.0778
91683851|NCT01994291|183257935|SUPERIORITY_OR_OTHER||Difference in LS means|114.07|STANDARD_ERROR_OF_MEAN|19.84|<|0.0001|TWO_SIDED|80.0|88.56|139.59|||Mixed Models Analysis|||||139.59|88.56|<0.0001
91683852|NCT01994291|183257935|SUPERIORITY_OR_OTHER||Difference in LS means|65.81|STANDARD_ERROR_OF_MEAN|18.36||0.0004|TWO_SIDED|80.0|42.2|89.43|||Mixed Models Analysis|||||89.43|42.20|0.0004
91683853|NCT01994291|183257935|SUPERIORITY_OR_OTHER||Difference in LS means|87.32|STANDARD_ERROR_OF_MEAN|15.44|<|0.0001|TWO_SIDED|80.0|67.45|107.19|||Mixed Models Analysis|||||107.19|67.45|<0.0001
91683854|NCT01994291|183257936|SUPERIORITY_OR_OTHER||Difference in LS means|7.98|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|80.0|6.13|9.83|||ANCOVA|||||9.83|6.13|<0.0001
91683855|NCT01994291|183257936|SUPERIORITY_OR_OTHER||Difference in LS means|6.34|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|80.0|4.7|7.98|||ANCOVA|||||7.98|4.70|<0.0001
91683856|NCT01994291|183257936|SUPERIORITY_OR_OTHER||Difference in LS means|7.07|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|80.0|5.66|8.48|||ANCOVA|||||8.48|5.66|<0.0001
91683857|NCT01994291|183257937|SUPERIORITY_OR_OTHER||Difference in LS means|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.0423|TWO_SIDED|80.0|0.13|0.55|||ANCOVA|||||0.55|0.13|0.0423
91683858|NCT01994291|183257937|SUPERIORITY_OR_OTHER||Difference in LS means|0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|80.0|0.36|0.75|||ANCOVA|||||0.75|0.36|0.0004
91683859|NCT01994291|183257937|SUPERIORITY_OR_OTHER||Difference in LS means|0.46|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|80.0|0.3|0.63|||ANCOVA|||||0.63|0.30|0.0004
91683860|NCT01775189|183257946|SUPERIORITY_OR_OTHER||Least Squares (LS) mean Difference|9.5||||0.0001|TWO_SIDED|95.0|4.8|14.2||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.2|4.8|0.0001
91683861|NCT01775189|183257946|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|95.0|-37.0|-27.6||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-27.6|-37.0|<0.0001
91683862|NCT01775189|183257946|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1||||0.0002|TWO_SIDED|95.0|4.5|13.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.8|4.5|0.0002
91683863|NCT01775189|183257946|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.8806|TWO_SIDED|95.0|-5.0|4.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|-5.0|0.8806
91683864|NCT01775189|183257946|SUPERIORITY_OR_OTHER||LS Mean Difference|41.4|||<|0.0001|TWO_SIDED|95.0|36.8|46.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.1|36.8|<0.0001
91683865|NCT01775189|183257946|SUPERIORITY_OR_OTHER||LS Mean Difference|41.8|||<|0.0001|TWO_SIDED|95.0|37.1|46.4||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|37.1|<0.0001
91683866|NCT01775189|183257947|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6||||0.2176|TWO_SIDED|95.0|-4.0|17.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-4.0|0.2176
91683867|NCT01775189|183257947|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-65.1|-44.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-44.1|-65.1|<0.0001
91683868|NCT01775189|183257947|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.3502|TWO_SIDED|95.0|-5.6|15.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.5|-5.6|0.3502
91683869|NCT01775189|183257947|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.7624|TWO_SIDED|95.0|-12.1|8.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.9|-12.1|0.7624
91683870|NCT01775189|183257947|SUPERIORITY_OR_OTHER||LS Mean Difference|59.6|||<|0.0001|TWO_SIDED|95.0|49.0|70.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|49.0|<0.0001
91683871|NCT01775189|183257947|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|50.6|71.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.7|50.6|<0.0001
91683872|NCT01775189|183257948|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|13.8|35.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.3|13.8|<0.0001
91683873|NCT01775189|183257948|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.7|||<|0.0001|TWO_SIDED|95.0|-72.6|-50.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-50.9|-72.6|<0.0001
91683874|NCT01775189|183257948|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0012|TWO_SIDED|95.0|7.4|29.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.1|7.4|0.0012
91718944|NCT02897349|183330729|SUPERIORITY||Adjusted Mean Difference (%)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0016|TWO_SIDED|95.0|-0.65|-0.16|||Mixed model repeated measures|||Based on Mixed-effect Model Repeated Measures (MMRM) including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||-0.16|-0.65|0.0016
91527642|NCT01976364|182930485|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-0.85|1.51||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.51|-0.85|
91683875|NCT01775189|183257948|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.2507|TWO_SIDED|95.0|-17.2|4.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.5|-17.2|0.2507
91683876|NCT01775189|183257948|SUPERIORITY_OR_OTHER||LS Mean Difference|79.9|||<|0.0001|TWO_SIDED|95.0|69.2|90.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.7|69.2|<0.0001
91683877|NCT01775189|183257948|SUPERIORITY_OR_OTHER||LS Mean Difference|86.3|||<|0.0001|TWO_SIDED|95.0|75.4|97.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.1|75.4|<0.0001
91683878|NCT01775189|183257949|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.0015|TWO_SIDED|95.0|10.6|43.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.1|10.6|0.0015
91683879|NCT01775189|183257949|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-125.7|-93.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-93.0|-125.7|<0.0001
91683880|NCT01775189|183257949|SUPERIORITY_OR_OTHER||LS Mean Difference|21.4||||0.0109|TWO_SIDED|95.0|5.1|37.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|5.1|0.0109
91683881|NCT01775189|183257949|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.4||||0.5117|TWO_SIDED|95.0|-21.8|10.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-21.8|0.5117
91683882|NCT01775189|183257949|SUPERIORITY_OR_OTHER||LS Mean Difference|130.8|||<|0.0001|TWO_SIDED|95.0|114.5|147.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.0|114.5|<0.0001
91683883|NCT01775189|183257949|SUPERIORITY_OR_OTHER||LS Mean Difference|136.2|||<|0.0001|TWO_SIDED|95.0|119.8|152.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||152.5|119.8|<0.0001
91683884|NCT00118534|183258015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.007|TWO_SIDED|95.0|1.22|3.59|||Regression, Logistic|||The target sample size (n=1400)was designed to have 90% power to detect the difference between 6% and 11% prolonged abstinence rates in SCC and IC, respectively, using a 2-sided .05 level Chi-square test. Final enrollment was 943. The recruitment period was not extended because the achieved sample size provided 78% power to detect the hypothesized prolonged abstinence rates, and the study continued to the end of planned follow-up.||3.59|1.22|0.007
91683885|NCT00118534|183258016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.58|3.74|||Regression, Logistic|||||3.74|1.58|<0.001
91683886|NCT02639052|183258083|SUPERIORITY_OR_OTHER|||||||0.9704||||||Significance defined a priori as p\<0.05. P-values not adjusted for multiple comparisons.|ANOVA with Repeated Measures|||Baseline assessment of itch VAS after itch induction but prior to Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.9704
91683887|NCT02639052|183258084|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 week (Visit 2) was the first assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
91683888|NCT02639052|183258085|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistically significant difference in mean itch VAS between the two treatments (Botox mean=2.45 versus saline mean=3.20, p\<0.0001). Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 month (Visit 3) was the second assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
91683889|NCT02639052|183258086|SUPERIORITY_OR_OTHER|||||||0.0004||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|Analyzed using ANOVA with repeated measures to compare treatment (Botox vs saline), time, and interaction effect between treatment \& time||3 months (Visit 4) was the third assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.0004
91683890|NCT02639052|183258087|SUPERIORITY_OR_OTHER|||||||0.1306||||||Statistical significance defined a priori as p\<0.05.|ANOVA with Repeated Measures|||Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and visit, and interaction effect between treatment and visit.||||0.1306
91683891|NCT03203564|183258103|OTHER||Mean Difference (Final Values)|7.4|||||TWO_SIDED|90.0|0.68|14.12|||||Parameter estimate is done for Placebo-corrected change-from baseline QTcF (ΔΔQTcF) for Modufolin 500 mg/m2 at end of infusion.|"The primary analysis of QTcF was based on a linear mixed-effects model with change-from-baseline QTcF as the dependent variable, time (categorical), treatment, and time-by-treatment interaction as fixed effects, and baseline QTcF as a covariate. The least-squares (LS) mean and 2-sided 90 % CIs have been calculated for the contrast Modufolin® versus placebo at each dose of Modufolin® and each post-dose time point."||14.12|0.68|
91683892|NCT00789737|183258129|SUPERIORITY_OR_OTHER|||||||0.0369||95.0|||||ANCOVA|||least squares mean; 80% power to detect a 0.3% change||||0.0369
91683893|NCT00789737|183258130|SUPERIORITY_OR_OTHER|||||||0.0373||95.0|||||ANCOVA|||||||0.0373
91683894|NCT00789737|183258135|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0|||||ANCOVA|||||||<0.00001
91683895|NCT02458287|183258142|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-72.0|-54.7|||Mixed Models Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction as covariates.||-54.7|-72.0|<0.001
91683896|NCT02458287|183258151|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|STANDARD_ERROR_OF_MEAN|4.53|<|0.001|TWO_SIDED|95.0|-51.9|-34.0|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.0|-51.9|<0.001
91683897|NCT02458287|183258152|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.7|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-45.4|-34.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.1|-45.4|<0.001
91683898|NCT02458287|183258152|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-32.5|-20.8|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-20.8|-32.5|<0.001
91683899|NCT02458287|183258153|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-66.2|-49.5|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-49.5|-66.2|<0.001
91683900|NCT02458287|183258153|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-44.4|-27.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-27.1|-44.4|<0.001
91683901|NCT02458287|183258154|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-63.7|-48.6|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-48.6|-63.7|<0.001
91683902|NCT02458287|183258154|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-45.0|-29.3|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-29.3|-45.0|<0.001
91683903|NCT02823652|183258215|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
91683904|NCT02823652|183258216|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91683905|NCT02823652|183258217|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|||||||0.312
91683906|NCT02823652|183258218|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91683907|NCT04428333|183258231|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and Human Papilloma Virus (HPV) status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
91683908|NCT04428333|183258232|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥ 20 vs 1≤ CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
91683909|NCT04428333|183258233|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
91683910|NCT04428333|183258234|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
91683911|NCT04428333|183258237|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-20.8|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-20.8|
91683912|NCT04428333|183258238|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-21.4|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-21.4|
91683913|NCT04428333|183258239|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-22.2|13.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.1|-22.2|
91683914|NCT04428333|183258240|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-22.8|13.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.3|-22.8|
91718945|NCT02897349|183330730|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-6.2|STANDARD_ERROR_OF_MEAN|5.1||0.2241|TWO_SIDED|95.0|-16.2|3.8|||Mixed model repeated measures|||Based on MMRM including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline FPG baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||3.8|-16.2|0.2241
91718946|NCT02897349|183330731|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-31.95|STANDARD_ERROR_OF_MEAN|8.2||0.0001|TWO_SIDED|95.0|-48.15|-15.75|||ANCOVA|||Based on analysis of covariance (ANCOVA) model including fixed effect treatment and type of insulin, and linear covariates baseline HbA1c and baseline 2-h PPG.||-15.75|-48.15|0.0001
91718947|NCT02897349|183330732|SUPERIORITY||Odds Ratio (OR)|1.793||||0.2431|TWO_SIDED|95.0|0.673|4.78|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.780|0.673|0.2431
91718948|NCT02897349|183330733|SUPERIORITY||Odds Ratio (OR)|1.481||||0.6235|TWO_SIDED|95.0|0.309|7.105|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||7.105|0.309|0.6235
91718949|NCT02897349|183330734|SUPERIORITY||Odds Ratio (OR)|2.293||||0.0049|TWO_SIDED|95.0|1.286|4.091|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.091|1.286|0.0049
91718950|NCT01142336|183330768|SUPERIORITY|||||||0.53||||||Threshold for significance: 0.05, adjust for 3 primary outcomes using Holm Correction|ANCOVA|Response variable was Aβ42 in CSF at 1 year, and predictor variables were Aβ42 in CSF at baseline, treatment group, age, sex, and APOE e4 allele.||||||0.53
91718951|NCT01142336|183330769|SUPERIORITY|||||||0.36||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction|ANCOVA|Response variable was total tau in CSF at 1 year, and predictor were total tau in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.36
91718952|NCT01142336|183330770|SUPERIORITY|||||||0.25||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction.|ANCOVA|Response variable was p-tau181 in CSF at 1 year, and predictor were p-tau181 in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.25
91718953|NCT01225055|183330774|SUPERIORITY|||||||0.84||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.84
91718954|NCT01225055|183330774|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.64
91718955|NCT01225055|183330774|SUPERIORITY|||||||0.26||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.26
91718956|NCT01225055|183330775|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.64
91527643|NCT01976364|182930485|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-1.04|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-1.04|
91527644|NCT01976364|182930485|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.09|0.55||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.55|-2.09|
91718957|NCT01225055|183330775|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.00
91718958|NCT01225055|183330775|SUPERIORITY|||||||0.09||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.09
91718959|NCT01225055|183330776|SUPERIORITY|||||||0.72||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.72
91718960|NCT01225055|183330776|SUPERIORITY|||||||0.58||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.58
91718961|NCT01225055|183330776|SUPERIORITY|||||||0.44||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.44
91718962|NCT01225055|183330777|SUPERIORITY|||||||0.02||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.02
91718963|NCT01225055|183330777|SUPERIORITY|||||||0.1||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.10
91718964|NCT01225055|183330777|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
91718965|NCT01225055|183330778|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.01
91718966|NCT01225055|183330778|SUPERIORITY|||||||0.34||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.34
91718967|NCT01225055|183330778|SUPERIORITY|||||||0.2||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.20
91718968|NCT01225055|183330779|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.00
91718969|NCT01225055|183330779|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.01
91718970|NCT01225055|183330779|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
91718971|NCT01123655|183330805|EQUIVALENCE|P less than 0.05 was the criteria for equivalence.||||||0.5179|||||||Fisher Exact|||Specified to be a reduction from baseline values of net IFNƔ concentration of ≥ 25% in αl(ll)-stimulated PBMC culture supernatants (calculated as αI(II)-IFNƔ-PBS IFNƔ in patients receiving APL A12 compared to placebo.||||0.5179
91718972|NCT01123655|183330805|EQUIVALENCE|Null hypothesis was that the response rate in the APL treated groups is not significantly difference from the 50% spontaneous response rate.||||||0.0114|||||||Exact Test|||||||0.0114
91718973|NCT01123655|183330805|EQUIVALENCE|Null hypothesis was that the response rate in the placebo group is not significantly difference from the 50% spontaneous response rate.||||||0.4142|||||||Exact Test|||||||0.4142
91718974|NCT01123655|183330807|EQUIVALENCE|P greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable for baseline and follow-up data.|Mixed Models Analysis|||||||>0.05
91718975|NCT01123655|183330808|EQUIVALENCE|p value greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable to IL-17a, IL-10, IL-1b, IL-9, IL-13, IL-5, IL-21, IL-6, TNFa, TGFb, MIP3a.|t-test, 2 sided|||||||>0.05
91718976|NCT05469438|183330842|OTHER|We assessed prediction accuracy of our system using the R\^2 from leave-one-out cross-validation of predicted Fugl-Meyer scores, which were obtained from models predicting recovery based on baseline data.|||||||||||||||||We assessed prediction accuracy of our system using the R\^2 from leave-one-out cross-validation of predicted Fugl-Meyer scores, which were obtained from models predicting recovery based on baseline data.|||
91718977|NCT02368132|183330843|SUPERIORITY||Least squares mean difference|-8.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Group Delivered TEP arm at 3 months.|||||<0.001
91718978|NCT02368132|183330843|SUPERIORITY||Least squares mean difference|-5.15|STANDARD_ERROR_OF_MEAN|2.42||0.04|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Individual Delivered TEP arm at 3 months.|||||0.04
91718979|NCT02475369|183330846|SUPERIORITY|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||0.271
91718980|NCT02475369|183330847|OTHER|In order to calculate a correlation between baseline fecal elastase-1 and total CeD-GSRS score on PES treatment vs. placebo treatment, we calculated a Spearman's rank correlation coefficient between the two independent variables.||||||0.995|||||||Spearman rank coefficient|||||||0.995
91718981|NCT02475369|183330848|OTHER|In order to evaluate the estimated difference of the effect of Pancreatic Enzyme Supplement versus Placebo for the Celiac Symptom Index (CSI) scores, we used a linear mixed effects model with the nlme package.||||||0.08|||||||Linear Mixed Effects model|||||||0.08
91718982|NCT00471497|183330849|OTHER||Difference in response rate|22.1|||<|0.0001|TWO_SIDED|95.0|14.5|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.5|<0.0001
91718983|NCT00471497|183330849|OTHER||Difference in response rate|20.4|||<|0.0001|TWO_SIDED|95.0|12.9|28.0|||Cochran-Mantel-Haenszel|||||28.0|12.9|<0.0001
91718984|NCT00471497|183330850|OTHER||Difference in response rate|14.8|||||TWO_SIDED|95.0|2.1|27.5||||||(Low)||27.5|2.1|
91718985|NCT00471497|183330850|OTHER||Difference in response rate|27.4|||||TWO_SIDED|95.0|14.6|40.2||||||(Low)||40.2|14.6|
91527645|NCT01976364|182930485|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.44|0.91||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.91|-2.44|
91718986|NCT00471497|183330850|OTHER||Difference in response rate|27.7|||||TWO_SIDED|95.0|15.0|40.4||||||(Intermediate)||40.4|15.0|
91718987|NCT00471497|183330850|OTHER||Difference in response rate|17.2|||||TWO_SIDED|95.0|4.6|29.8||||||(Intermediate)||29.8|4.6|
91718988|NCT00471497|183330850|OTHER||Difference in response rate|24.4|||||TWO_SIDED|95.0|10.7|38.1||||||(High)||38.1|10.7|
91718989|NCT00471497|183330850|OTHER||Difference in response rate|15.4|||||TWO_SIDED|95.0|2.1|28.6||||||(High)||28.6|2.1|
91718990|NCT00471497|183330851|OTHER||Difference in response rate|21.3|||||TWO_SIDED|95.0|13.9|28.8||||||||28.8|13.9|
91718991|NCT00471497|183330851|OTHER||Difference in response rate|18.7|||||TWO_SIDED|95.0|11.3|26.0||||||||26.0|11.3|
91718992|NCT00471497|183330853|OTHER||Absolute difference|-1.6||||0.6987|TWO_SIDED|95.0|-9.8|6.6|||Cochran-Mantel-Haenszel|||||6.6|-9.8|0.6987
91718993|NCT01991795|183330905|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0378|TWO_SIDED|95.0|0.81|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.81|0.0378
91718994|NCT01991795|183330906|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.7883|TWO_SIDED|95.0|0.88|1.18||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.18|0.88|0.7883
91718995|NCT01991795|183330907|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0294|TWO_SIDED|95.0|0.71|0.98||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.98|0.71|0.0294
91718996|NCT01991795|183330908|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0375|TWO_SIDED|95.0|0.64|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.64|0.0375
91718997|NCT01991795|183330909|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.6846|TWO_SIDED|95.0|0.87|1.1|||Regression, Cox|||||1.10|0.87|0.6846
91718998|NCT01991795|183330910|SUPERIORITY||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.82|2.94|||Regression, Cox|||||2.94|1.82|<0.0001
91718999|NCT01991795|183330911|SUPERIORITY||Hazard Ratio (HR)|2.49|||<|0.0001|TWO_SIDED|95.0|2.02|3.07|||Regression, Cox|||||3.07|2.02|<0.0001
91719000|NCT01991795|183330912|SUPERIORITY||Hazard Ratio (HR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.98|2.93|||Regression, Cox|||||2.93|1.98|<0.0001
91719001|NCT01991795|183330913|SUPERIORITY||Hazard Ratio (HR)|4.04|||<|0.0001|TWO_SIDED|95.0|3.32|4.92|||Regression, Cox|||||4.92|3.32|<0.0001
91719002|NCT01232283|183330932|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.0|||<|0.0001|TWO_SIDED|95.0|16.3|29.6|||Chi-squared|||||29.6|16.3|<0.0001
91719003|NCT01232283|183330933|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.2|21.9|||Chi-squared|||||21.9|10.2|<0.0001
91719004|NCT01232283|183330934|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-42.15|||<|0.0001|TWO_SIDED|95.0|-51.11|-33.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-33.20|-51.11|<0.0001
91683915|NCT04428333|183258257|SUPERIORITY|Other|Hazard Ratio (HR)|0.85||||0.329|TWO_SIDED|95.0|0.42|1.71||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.71|0.42|0.329
91683916|NCT04428333|183258258|SUPERIORITY|Other|Hazard Ratio (HR)|0.82||||0.302|TWO_SIDED|95.0|0.4|1.69||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.69|0.40|0.302
91683917|NCT04428333|183258259|SUPERIORITY|Other|Hazard Ratio (HR)|0.96||||0.472|TWO_SIDED|95.0|0.44|2.11||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.11|0.44|0.472
91683918|NCT04428333|183258260|SUPERIORITY|Other|Hazard Ratio (HR)|0.83||||0.335|TWO_SIDED|95.0|0.36|1.9||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.90|0.36|0.335
91683919|NCT04853992|183258261|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.5||0.277|TWO_SIDED|95.0|-1.69|0.53|||Mixed Models Analysis|||The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate.||0.53|-1.69|0.277
91683920|NCT02135614|183258297|SUPERIORITY||Treatment difference|0.12||||0.46|TWO_SIDED|95.0|-0.2|0.43||P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates.|ANCOVA|||||0.43|-0.20|0.46
91683921|NCT02135614|183258298|SUPERIORITY||Treatment difference|0.08||||0.046|TWO_SIDED|95.0|0.0|0.16||P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates.|ANCOVA|||||0.16|0.00|0.046
91683922|NCT02135614|183258299|SUPERIORITY|||||||0.39||||||P-value was calculated from the negative binomial model with the stratification factor as covariate.|Negative Binomial Model|||||||0.39
91683923|NCT02135614|183258300|SUPERIORITY|||||||0.004||||||P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor.|Negative Binomial Model|||||||0.004
91683924|NCT01421511|183258327|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-3.0|8.2|||||Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.|||8.2|-3.0|
91683925|NCT01421511|183258328|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-6.1|4.1||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.1|-6.1|
91683926|NCT01421511|183258329|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-8.8|0.3|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||0.3|-8.8|
91683927|NCT01421511|183258330|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-4.8|5.3|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||5.3|-4.8|
91527646|NCT01976364|182930485|OTHER||LS mean difference|0.52|||||TWO_SIDED|95.0|-0.96|2.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.00|-0.96|
91527647|NCT01976364|182930486|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.22|1.29||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.29|-2.22|
91683928|NCT01421511|183258331|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.7|0.2|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||0.2|-7.7|
91683929|NCT01421511|183258332|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-3.3|5.6|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.||5.6|-3.3|
91683930|NCT01421511|183258333|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-3.2|4.9|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.||4.9|-3.2|
91683931|NCT00106964|183258352|SUPERIORITY_OR_OTHER|||||||0.044|||||||Chi-squared|||||||0.0440
91683932|NCT00106964|183258352|SUPERIORITY_OR_OTHER|||||||0.0157|||||||Chi-squared|||||||0.0157
91683933|NCT00106964|183258356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.5822||95.0|||||Regression, Cox|||||||0.5822
91683934|NCT00106964|183258356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.8698||95.0|||||Regression, Cox|||||||0.8698
91683935|NCT00106964|183258357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.29||||0.0853|TWO_SIDED|95.0|0.07|1.19|||Regression, Logistic||Adjusted odds ratio (OR) Odds ratio depends on CD4 count resulting from interaction. For example, OR=0.29 for CD4 count = 0; OR= 2.91 for CD4 count = 460 (median CD4 count for the evaluable study population).|||1.19|0.07|0.0853
91683936|NCT00106964|183258357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.0244|TWO_SIDED|95.0|1.09|3.63|||Regression, Logistic||Adjusted odds ratio|||3.63|1.09|0.0244
91683937|NCT04040192|183258358|OTHER|||||||0.0034||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.0034
91683938|NCT04040192|183258360|OTHER|Analysis of covariance (ANCOVA) model included fixed effects of treatment group, age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Least square mean difference|34.59|STANDARD_ERROR_OF_MEAN|16.274||0.0346|TWO_SIDED|95.0|2.53|66.64|||ANCOVA|||||66.64|2.53|0.0346
91683939|NCT04040192|183258361|OTHER||Median Difference (Final Values)|-0.5||||0.0042|TWO_SIDED|95.0|-1.0|0.0||p-value was estimated by Wilcoxon rank sum test stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Wilcoxon (Mann-Whitney)||Median difference and 95%CI were estimated using Hodges-Lehmann method.|||0.00|-1.00|0.0042
91683940|NCT04040192|183258362|OTHER|||||||0.6815||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=3 and \>=3 point reduction in PP NRS||||0.6815
91683941|NCT04040192|183258362|OTHER|||||||0.1518||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=4 and \>=4 point reduction in PP NRS||||0.1518
91683942|NCT04040192|183258363|OTHER|||||||0.1933||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization|Log Rank|||||||0.1933
91683943|NCT04040192|183258364|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.3778|||||||Log Rank|||Baseline ORIS Scale \>=3 and \>=3 point reduction||||0.3778
91683944|NCT04040192|183258364|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.487|||||||Log Rank|||Baseline ORIS Scale \>=4 and \>=4 point reduction||||0.4870
91683945|NCT04040192|183258365|OTHER|||||||0.1159||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.1159
91683946|NCT04040192|183258366|OTHER|||||||0.6973||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||DLQI for participants \>=16 years of age||||0.6973
91683947|NCT04040192|183258366|OTHER|||||||0.7456||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Children's DLQI: participants 4-\<16 yrs of age||||0.7456
91683948|NCT04040192|183258367|OTHER|||||||0.0513||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||POEM||||0.0513
91683949|NCT04040192|183258367|OTHER|||||||0.0217||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Proxy POEM||||0.0217
91683950|NCT03207243|183258460|OTHER||Median Rate Ratio|0.82|||||TWO_SIDED|95.0|0.66|0.99|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||0.99|0.66|
91719005|NCT01232283|183330935|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.8|||<|0.0001|TWO_SIDED|95.0|-42.4|-27.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-27.2|-42.4|<0.0001
91719006|NCT01232283|183330936|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.8|||<|0.0001|TWO_SIDED|95.0|26.9|44.7|||Chi-squared|||||44.7|26.9|< 0.0001
91719007|NCT01232283|183330937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.3|||<|0.0001|TWO_SIDED|95.0|-28.4|-14.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-14.2|-28.4|<0.0001
91719008|NCT01232283|183330938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.8|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-2.8|-5.3|<0.0001
91719009|NCT01232283|183330939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.63||||0.0078|TWO_SIDED|95.0|0.69|4.56|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.56|0.69|0.0078
91719010|NCT01232283|183330940|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2|||<|0.0001|TWO_SIDED|95.0|8.5|20.0|||Chi-squared|||||20.0|8.5|<0.0001
91719011|NCT01232283|183330941|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.7|||<|0.0001|TWO_SIDED|95.0|3.408|17.399|||Log Rank|||||17.399|3.408|<0.0001
91719012|NCT01141608|183330948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Linear mixed effects model|||||||<0.05
91719013|NCT00855218|183330955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.072||95.0|0.588|1.08||stratified one-sided (alpha=0.15). adjusted for region and Alfa-fetoprotein (AFP) level at baseline.|Log Rank|||||1.080|0.588|0.072
91719014|NCT00855218|183330956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.295||95.0|0.606|1.33|||Log Rank|stratified one-sided (alpha=0.15). adjusted for region and AFP level at baseline.||||1.330|0.606|0.295
91527648|NCT01976364|182930486|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.65|0.92||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.92|-2.65|
91719015|NCT00855218|183330957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.586||||0.999||95.0|1.2|2.096|||Log Rank|startified one-sided (alpha=0.15), adjusted for region and AFP level at baseline||||2.096|1.200|0.999
91719016|NCT00855218|183330958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.076||95.0|0.321|1.2|||Log Rank|stratified one sided (alpha=0.15), adjusted on region and AFP level at baseline||||1.200|0.321|0.076
91719017|NCT02941640|183330967|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05|ANOVA|||||||<0.0001
91719018|NCT02941640|183330967|OTHER|||||||0.001||||||Significant when P\<0.05.|Tukey post hoc test|||Post hoc analysis was done by Tukey test.||||0.001
91719019|NCT02941640|183330967|OTHER|Tukey post hoc test|||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
91719020|NCT02941640|183330967|OTHER|||||||0.044||||||Significant when P\<0.05|Tukey post hoc test|||||||0.044
91719021|NCT02941640|183330967|OTHER||||||<|0.272||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.272
91719022|NCT02941640|183330967|OTHER|||||||0.835||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.835
91719023|NCT02941640|183330967|OTHER|||||||0.199||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.199
91719024|NCT02941640|183330968|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05.|ANOVA|||||||<0.0001
91719025|NCT02941640|183330968|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
91719026|NCT02941640|183330968|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
91719027|NCT02941640|183330968|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
91719028|NCT02941640|183330968|OTHER||||||<|0.0001|||||||Tukey post hoc test|||||||<0.0001
91719029|NCT02941640|183330968|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
91719030|NCT02941640|183330968|OTHER|||||||1||||||Significant when P\<0.05|Tukey post hoc test|||||||1.00
91719031|NCT00506675|183330970|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
91719032|NCT00506675|183330971|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|||||||0.30
91719033|NCT00506675|183330972|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
91719034|NCT03658980|183330991|SUPERIORITY||Odds Ratio (OR)|0.233|||<|0.001|TWO_SIDED|95.0|0.131|0.415|||Regression, Logistic|||||0.415|0.131|<0.001
91719035|NCT03141359|183330995|SUPERIORITY||Rate|0.627||||0.388|TWO_SIDED|95.0|0.492|0.75|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|We used a single-stage design to test null hypothesis (H0) that 1-yr PFS is \<= 0.60. Assuming one-sided α= 0.10, 60 patients provided 98% power to reject H0, assuming the true 1-yr PFS is 0.80. Since not all enrolled subjects received durva, study power was affected. For patients who did not receive durva, H0 was assumed to be 0.40 versus an alternative of 0.60. Including these subjects reduced power from 98%. The conditional power given that 13 evaluable subjects didn't receive durva was 88%.||0.750|0.492|.388
91719036|NCT03141359|183330998|OTHER|Estimation only|Rate|0.571|||||TWO_SIDED|95.0|0.422|0.712|||||Confidence interval estimated using the Clopper Pearson method.|||0.712|0.422|
91719037|NCT03141359|183330999|OTHER|Estimation only|Rate|0.75|||||TWO_SIDED|95.0|0.621|0.853|||||Confidence interval estimated using the Clopper Pearson method.|||0.853|0.621|
91719038|NCT03141359|183331007|OTHER|Estimation only|Rate|0.164|||||TWO_SIDED|95.0|0.082|0.281|||||Confidence interval estimated using the Clopper Pearson method.|||0.281|0.082|
91719039|NCT03141359|183331008|OTHER|Estimation only|Rate|0.246|||||TWO_SIDED|95.0|0.145|0.373|||||Confidence interval estimated using the Clopper Pearson method.|||0.373|0.145|
91722504|NCT06001021|183337813|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|7.62||0|TWO_SIDED|90.0|15.16|18.04||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Psychological Domain of Quality of Life||18.04|15.16|0.000
91527649|NCT01976364|182930486|OTHER||LS mean difference|-0.66|||||TWO_SIDED|95.0|-2.68|1.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.36|-2.68|
91683951|NCT03207243|183258465|OTHER||Median Rate Ratio|0.71|||||TWO_SIDED|95.0|0.44|1.01|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||1.01|0.44|
91683952|NCT03207243|183258466|OTHER|||||||0.044|||||||Log Rank|||||||0.044
91683953|NCT03207243|183258510|OTHER||Percent change|-93.4|||<|0.001|TWO_SIDED|95.0|-94.9|-91.7||Week 4|mixed model repeated measures analysis|||||-91.7|-94.9|<0.001
91683954|NCT03207243|183258510|OTHER||Percent change|-92.9|||<|0.001|TWO_SIDED|95.0|-94.8|-90.3||Week 8|mixed model repeated measures analysis|||||-90.3|-94.8|<0.001
91683955|NCT03207243|183258510|OTHER||Percent change|-93.2|||<|0.001|TWO_SIDED|95.0|-95.4|-90.0||Week 12|mixed model repeated measures analysis|||||-90.0|-95.4|<0.001
91683956|NCT03207243|183258510|OTHER||Percent change|-93.3|||<|0.001|TWO_SIDED|95.0|-95.3|-90.4||Week 16|mixed model repeated measures analysis|||||-90.4|-95.3|<0.001
91683957|NCT03207243|183258511|OTHER||Percent change|2300.4|||<|0.001|TWO_SIDED|95.0|1833.9|2879.3||Week 4|mixed model repeated measures analysis|||||2879.3|1833.9|<0.001
91683958|NCT03207243|183258511|OTHER||Percent change|2507.7|||<|0.001|TWO_SIDED|95.0|1924.2|3259.4||Week 8|mixed model repeated measures analysis|||||3259.4|1924.2|<0.001
91683959|NCT03207243|183258511|OTHER||Percent change|2162.2|||<|0.001|TWO_SIDED|95.0|1489.1|3120.3||Week 12|mixed model repeated measures analysis|||||3120.3|1489.1|<0.001
91683960|NCT03207243|183258511|OTHER||Percent change|2663.0|||<|0.001|TWO_SIDED|95.0|1994.6|3544.8||Week 16|mixed model repeated measures analysis|||||3544.8|1994.6|<0.001
91683961|NCT00603837|183258521|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||t-test, 1 sided|||||||0.445
91683962|NCT02318303|183258527|SUPERIORITY||Mean Difference (Final Values)|-1.1087|||<|0.0001|TWO_SIDED|97.5|-1.669|-0.5485|||ANCOVA|||||-0.5485|-1.6690|<0.0001
91683963|NCT02318303|183258527|SUPERIORITY||Mean Difference (Final Values)|-1.1703|||<|0.0001|TWO_SIDED|97.5|-1.7315|-0.609|||ANCOVA|||||-0.6090|-1.7315|<0.0001
91683964|NCT02318303|183258527|SUPERIORITY||Mean Difference (Final Values)|-0.7718||||0.002|TWO_SIDED|95.0|-1.2616|-0.282|||ANCOVA|||||-0.2820|-1.2616|0.0020
91683965|NCT02318303|183258527|SUPERIORITY||Mean Difference (Final Values)|-0.3563||||0.1524|TWO_SIDED|95.0|-0.8445|0.1319|||ANCOVA|||||0.1319|-0.8445|0.1524
91683966|NCT02318303|183258527|SUPERIORITY||Mean Difference (Final Values)|-0.4918||||0.0488|TWO_SIDED|95.0|-0.981|-0.0025|||ANCOVA|||||-0.0025|-0.9810|0.0488
91683967|NCT02318303|183258527|SUPERIORITY||Mean Difference (Final Values)|-0.7133||||0.0043|TWO_SIDED|95.0|-1.2031|-0.2235|||ANCOVA|||||-0.2235|-1.2031|0.0043
91683968|NCT02960490|183258532|SUPERIORITY||Difference from Placebo|-4.7||||0.621|TWO_SIDED|95.0|-25.85|16.46|||Regression, Logistic|||||16.46|-25.85|0.621
91683969|NCT02368314|183258581|SUPERIORITY_OR_OTHER|||||||0.226|||||||Fisher Exact|||||||0.226
91683970|NCT01266031|183258600|SUPERIORITY_OR_OTHER|||||||0.26||||||Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|Chi-squared|||Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.||||0.26
91683971|NCT02047734|183258649|SUPERIORITY||Rate Ratio|0.623|||<|0.0001|TWO_SIDED|95.0|0.506|0.768||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.768|0.506|<0.0001
91683972|NCT02047734|183258649|SUPERIORITY||Rate Ratio|0.791||||0.0167|TWO_SIDED|95.0|0.652|0.958||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.958|0.652|0.0167
91683973|NCT02047734|183258650|SUPERIORITY||Rate Ratio|0.576|||<|0.0001|TWO_SIDED|95.0|0.465|0.714||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions, and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.714|0.465|<0.0001
91683974|NCT02047734|183258650|SUPERIORITY||Rate Ratio|0.657||||0.0001|TWO_SIDED|95.0|0.531|0.813||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, age, and Baseline GdE lesions and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.813|0.531|0.0001
91683975|NCT02047734|183258651|SUPERIORITY||Rate Ratio|0.471||||0.0006|TWO_SIDED|95.0|0.306|0.725||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.725|0.306|0.0006
91683976|NCT02047734|183258651|SUPERIORITY||Rate Ratio|0.528||||0.003|TWO_SIDED|95.0|0.346|0.805||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model,|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.805|0.346|0.0030
91683977|NCT02047734|183258652|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.8224|TWO_SIDED|95.0|0.711|1.537||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World) age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.537|0.711|0.8224
91683978|NCT02047734|183258652|SUPERIORITY||Hazard Ratio (HR)|0.798||||0.2849|TWO_SIDED|95.0|0.528|1.206||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.206|0.528|0.2849
91683979|NCT02047734|183258653|SUPERIORITY||Hazard Ratio (HR)|1.435||||0.1353|TWO_SIDED|95.0|0.893|2.305||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||2.305|0.893|0.1353
91683980|NCT02047734|183258653|SUPERIORITY||Hazard Ratio (HR)|1.098||||0.7154|TWO_SIDED|95.0|0.664|1.815||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.815|0.664|0.7154
91683981|NCT02047734|183258654|SUPERIORITY||Difference|9.4||||0.0047|TWO_SIDED|95.0|2.9|15.8|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||15.8|2.9|0.0047
91683982|NCT02047734|183258654|SUPERIORITY||Difference|7.1||||0.032|TWO_SIDED|95.0|0.6|13.6|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||13.6|0.6|0.0320
91683983|NCT02047734|183258655|SUPERIORITY||Difference|5.4||||0.0466|TWO_SIDED|95.0|0.0|10.8|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.8|0.0|0.0466
91683984|NCT02047734|183258655|SUPERIORITY||Difference|5.1||||0.0581|TWO_SIDED|95.0|-0.3|10.5|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.5|-0.3|0.0581
91683985|NCT02047734|183258656|SUPERIORITY||Difference in means|0.244|||<|0.0001|TWO_SIDED|95.0|0.125|0.363||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.363|0.125|<0.0001
91683986|NCT02047734|183258656|SUPERIORITY||Difference in means|0.224||||0.0002|TWO_SIDED|95.0|0.106|0.342||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.342|0.106|0.0002
91683987|NCT02047734|183258657|SUPERIORITY||Difference in means|0.043||||0.248|TWO_SIDED|95.0|-0.03|0.116|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means are based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.116|-0.030|0.2480
91683988|NCT02047734|183258657|SUPERIORITY||Difference in means|0.093||||0.0123|TWO_SIDED|95.0|0.02|0.165|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.165|0.020|0.0123
91683989|NCT02047734|183258658|SUPERIORITY||Difference in means|1.345||||0.0988|TWO_SIDED|95.0|-0.252|2.943|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||2.943|-0.252|0.0988
91683990|NCT02047734|183258658|SUPERIORITY||Difference in means|1.849||||0.0228|TWO_SIDED|95.0|0.258|3.44|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score.|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||3.440|0.258|0.0228
91683991|NCT02047734|183258658|SUPERIORITY||Difference in means|0.38||||0.6997|TWO_SIDED|95.0|-1.553|2.313|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.313|-1.553|0.6997
91719040|NCT03675308|183331014|SUPERIORITY||Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.0|30.0||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of baseline psoriasis (≥ 3%/\< 3% body surface area), presence of dactylitis (yes/no), presence of enthesitis (yes/no) and current csDMARD use (0/≥ 1).||30.0|18.0|<0.001
91719041|NCT03675308|183331015|SUPERIORITY||Least Squares (LS) Mean Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-0.26|-0.14||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.14|-0.26|<0.001
91719042|NCT03675308|183331016|SUPERIORITY||Response Rate Difference|42.5|||<|0.001|TWO_SIDED|95.0|35.6|49.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||49.3|35.6|<0.001
91719043|NCT03675308|183331017|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|16.8|29.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||29.4|16.8|<0.001
91719044|NCT03675308|183331018|SUPERIORITY||Response Rate Difference|14.8|||<|0.001|TWO_SIDED|95.0|10.2|19.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||19.4|10.2|<0.001
91719045|NCT03675308|183331019|SUPERIORITY||LS Mean Difference|-4.19|||<|0.001|TWO_SIDED|95.0|-5.7|-2.68||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-2.68|-5.70|<0.001
91719046|NCT03675308|183331020|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.3|-0.6|<0.001
91719047|NCT03675308|183331021|SUPERIORITY||Response Rate Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.6|20.2||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use and extent of psoriasis at Baseline and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||20.2|7.6|<0.001
91719048|NCT03675308|183331022|SUPERIORITY||Response Rate Difference|16.9|||<|0.001|TWO_SIDED|95.0|7.5|26.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, extent of psoriasis at Baseline, and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||26.4|7.5|<0.001
91719049|NCT03675308|183331023|SUPERIORITY||LS Mean Difference|-0.09||||0.496|TWO_SIDED|95.0|-0.36|0.17||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|ANCOVA|ANCOVA model including treatment and the stratification factors and baseline value as covariates.|Difference = Risankizumab - Placebo|||0.17|-0.36|0.496
91719050|NCT03675308|183331024|OTHER||LS Mean Difference|3.32|||<|0.001|TWO_SIDED|95.0|2.42|4.22||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||4.22|2.42|<0.001
91527650|NCT01976364|182930486|OTHER||LS mean difference|0.76|||||TWO_SIDED|95.0|-1.31|2.83||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.83|-1.31|
91527651|NCT01976364|182930486|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.01|1.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.84|-2.01|
91683992|NCT02047734|183258658|SUPERIORITY||Difference in means|0.587||||0.5501|TWO_SIDED|95.0|-1.339|2.513|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and the Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.513|-1.339|0.5501
91683993|NCT02047734|183258660|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
91683994|NCT02047734|183258660|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
91683995|NCT01333397|183258661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 20 U Vs Placebo||||<0.0001
91683996|NCT01333397|183258661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 50 U Vs Placebo||||<0.0001
91683997|NCT01333397|183258661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 75 U Vs Placebo||||<0.0001
91683998|NCT01333397|183258661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 20 U Vs Placebo||||<0.0001
91683999|NCT01333397|183258661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 50 U Vs Placebo||||<0.0001
91684000|NCT01333397|183258661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 75 U Vs Placebo||||<0.0001
91684001|NCT00314951|183258683|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-2.9|8.0||||||H0: C(fidaxomicin) - C(Vancomycin) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||8.0|-2.9|
91684002|NCT00314951|183258684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.4||||0.008|TWO_SIDED|95.0|-16.2|-2.5|||Chi-squared|||||-2.5|-16.2|0.008
91684003|NCT00314951|183258685|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.2||||0.007|TWO_SIDED|95.0|2.8|17.5|||Chi-squared|||||17.5|2.8|0.007
91684004|NCT04411914|183258686|SUPERIORITY|||||||0.0009|||||||Spearman Correlation Coefficient|||||||0.0009
91684005|NCT04411914|183258687|OTHER|||||||0.0053|||||||Spearman Correlation Coefficient|"Spearman Correlation Coefficient, N=9 Prob \> \|r\| under H0: Rho=0"||||||0.0053
91684006|NCT00423319|183258722|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.22|0.54||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.54|0.22|<0.0001
91684007|NCT00423319|183258722|SUPERIORITY_OR_OTHER||Risk Difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.54|1.5||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||1.50|-3.54|<0.0001
91684008|NCT00423319|183258723|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.15|0.8||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.80|0.15|<0.0001
91684009|NCT00423319|183258723|SUPERIORITY_OR_OTHER||Risk difference|-0.68||||0.0054|TWO_SIDED|95.0|-1.27|-0.17||Statistically significant at the 1-sided 0.025 level|Chi-squared||Apixaban-enoxaparin|||-0.17|-1.27|0.0054
91684010|NCT00423319|183258725|SUPERIORITY_OR_OTHER||Difference in event rates|0.15||||0.54|TWO_SIDED|95.0|-0.33|0.64||2-sided P-Value|Chi-squared||Major bleeding. Apixaban-enoxaparin|||0.64|-0.33|0.54
91684011|NCT00423319|183258725|SUPERIORITY_OR_OTHER||Difference in event rates|-0.44||||0.43|TWO_SIDED|95.0|-1.53|0.66||2-sided P-Value|Chi-squared||CRNM. Apixaban-enoxaparin|||0.66|-1.53|0.43
91684012|NCT00423319|183258725|SUPERIORITY_OR_OTHER||Difference in event rates|-0.21||||0.72|TWO_SIDED|95.0|-1.38|0.95||2-sided P-Value|Chi-squared||Major or CRNM. Apixaban-enoxaparin|||0.95|-1.38|0.72
91684013|NCT00423319|183258725|SUPERIORITY_OR_OTHER||Difference in event rate|-0.85||||0.34|TWO_SIDED|95.0|-2.61|0.9||2-sided P-Value|Chi-squared||Any bleeding. Apixaban-enoxaparin|||0.90|-2.61|0.34
91684014|NCT00423319|183258735|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||Apixaban-enoxaparin. MI/stroke|||0.26|-0.34|
91684015|NCT00423319|183258735|SUPERIORITY_OR_OTHER||Difference in event rates|0.07|||||TWO_SIDED|95.0|-0.17|0.34|||||Apixaban-enoxaparin. MI|||0.34|-0.17|
91684016|NCT00423319|183258735|SUPERIORITY_OR_OTHER||Difference in event rates|-0.11|||||TWO_SIDED|95.0|-0.35|0.07|||||Apixaban-enoxaparin. Stroke|||0.07|-0.35|
91684017|NCT00423319|183258735|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.26|0.17|||||Apixaban-enoxaparin. Thrombocytopenia|||0.17|-0.26|
91684018|NCT04630158|183258751|SUPERIORITY||Least Square (LS) mean difference|1.6|STANDARD_ERROR_OF_MEAN|5.1||0.93|TWO_SIDED|95.0|-8.5|11.7||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||11.7|-8.5|0.930
91684019|NCT04630158|183258751|SUPERIORITY||Least Square (LS) mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.11||0.699|TWO_SIDED|95.0|-6.4|13.8||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||13.8|-6.4|0.699
91684020|NCT05162014|183258768|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|Cox proportional hazards regression models based on time-to-first acute pancreatitis used to estimate the hazard ratios.||||1.02|0.76|
91684021|NCT01943994|183258792|SUPERIORITY||Odds Ratio (OR)|6.12||||0.003|TWO_SIDED|95.0|1.99|23.26|||Regression, Logistic|||||23.26|1.99|0.003
91684022|NCT00642278|183258798|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.747|-0.148||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.148|-0.747|<0.001
91684023|NCT00642278|183258798|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.804|-0.207||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.207|-0.804|<0.001
91684024|NCT00642278|183258798|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.841|-0.244||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.244|-0.841|<0.001
91684025|NCT00642278|183258798|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.006|-0.405||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.405|-1.006|<0.001
91684026|NCT00642278|183258798|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-1.029|-0.432||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.432|-1.029|<0.001
91684027|NCT00642278|183258798|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.862|-0.265||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.265|-0.862|<0.001
91684028|NCT00642278|183258799|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.34|-1.39|0.001
91684029|NCT00642278|183258799|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.98|-0.92|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.92|-1.98|<0.001
91684030|NCT00642278|183258799|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.33|-1.27|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.27|-2.33|<0.001
91684031|NCT00642278|183258799|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.32|-1.26|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.26|-2.32|<0.001
91684032|NCT00642278|183258799|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.25|-1.19|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.19|-2.25|<0.001
91684033|NCT00642278|183258799|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.46|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.46|-1.51|<0.001
91684034|NCT00642278|183258801|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|26.07|46.13|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||46.13|26.07|<0.001
91684035|NCT00642278|183258801|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|49.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|39.17|59.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.34|39.17|<0.001
91684036|NCT00642278|183258801|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|48.2|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|37.98|58.42|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||58.42|37.98|<0.001
91684037|NCT00642278|183258801|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|49.0|STANDARD_ERROR_OF_MEAN|5.11|<|0.001|TWO_SIDED|95.0|38.91|59.01|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.01|38.91|<0.001
91684038|NCT00642278|183258801|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|60.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|50.17|70.35|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||70.35|50.17|<0.001
91684039|NCT00642278|183258801|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|5.09||0.513|TWO_SIDED|95.0|-13.33|6.67|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||6.67|-13.33|0.513
91684040|NCT00642278|183258803|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.5||0.009|TWO_SIDED|95.0|-2.2|-0.3|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.3|-2.2|0.009
91684041|NCT00642278|183258803|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.002|TWO_SIDED|95.0|-2.5|-0.6|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.6|-2.5|0.002
91684042|NCT00642278|183258803|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.||||-0.7|-2.6|<0.001
91684043|NCT00642278|183258803|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
91684044|NCT00642278|183258803|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
91684045|NCT00642278|183258803|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.371|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||1.4|-0.5|0.371
91684046|NCT03713619|183258804|SUPERIORITY||Odds Ratio, log|1.75||||0.007|TWO_SIDED|95.0|1.12|2.73|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.73|1.12|0.0070
91719051|NCT03675308|183331025|OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.5|3.7||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.7|1.5|<0.001
91719052|NCT03675308|183331026|SUPERIORITY||Response Rate Difference|22.2|||<|0.001|TWO_SIDED|95.0|17.3|27.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||27.2|17.3|<0.001
91719053|NCT03675308|183331027|SUPERIORITY||Response Rate Difference|10.5|||<|0.001|TWO_SIDED|95.0|6.9|14.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||14.2|6.9|<0.001
91719054|NCT04953338|183331064|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.92|1.32|||||Calculated as the relative risk of a person diagnosed with vitiligo having a depression episode versus people not diagnosed with vitiligo|||1.32|0.92|
91719055|NCT04953338|183331067|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|1.01|1.51|||||Calculated as the relative risk of a person diagnosed with vitiligo having with anxiety disorder versus people not diagnosed with vitiligo|||1.51|1.01|
91719056|NCT04953338|183331068|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.56|||||Calculated as the relative risk of a person diagnosed with vitiligo having with recurrent depressive disorder versus people not diagnosed with vitiligo|||1.56|1.01|
91719057|NCT01721798|183331069|NON_INFERIORITY|Primary Outcome Analysis: Proportion of women with detectable genital viral load across 24 months|Odds Ratio (OR)|0.87||||0.66|TWO_SIDED|95.0|0.47|1.62|||GEE|||C-IUD is comparator group.||1.62|0.47|0.66
91719058|NCT01721798|183331070|NON_INFERIORITY|Secondary Outcome Analysis of Proportion with Detectable plasma viral load users at 24 months|Odds Ratio (OR)|0.83||||0.64|TWO_SIDED|95.0|0.37|1.86|||GEE|Adjusted as-treated analysis||C-IUD is comparator group.||1.86|0.37|0.64
91719059|NCT01721798|183331072|NON_INFERIORITY|Secondary Outcome Analysis of Allocated IUC continuation at 24 months|Hazard Ratio (HR)|8.61|||<|0.001|TWO_SIDED|95.0|3.03|24.4|||Regression, Cox|||C-IUD is comparator group.||24.4|3.03|<0.001
91719060|NCT00089648|183331089|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|23.0||||||95.0|13.2|35.5|||||ORR=proportion of subjects with confirmed CR or PR, relative to total number of subjects who received at least 1 dose of study medication, were refractory to bevacizumab, had a baseline disease assessment and had the correct histological cancer type.|||35.5|13.2|
91719061|NCT03979313|183331102|SUPERIORITY||Relative Risk Reduction (RRR)|62.15||||0.0708|TWO_SIDED|95.0|-8.57|86.8|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||86.80|-8.57|0.0708
91719062|NCT03979313|183331103|SUPERIORITY||Relative Risk Reduction (RRR)|74.53|||<|0.0001|TWO_SIDED|95.0|49.63|87.12|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||87.12|49.63|<0.0001
91719063|NCT03979313|183331104|SUPERIORITY||Relative Risk Reduction (RRR)|76.36|||<|0.0001|TWO_SIDED|95.0|62.27|85.18|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||85.18|62.27|<0.0001
91527652|NCT01976364|182930487|OTHER||LS mean difference|0.22|||||TWO_SIDED|95.0|-1.09|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.09|
91719064|NCT03979313|183331105|SUPERIORITY||Relative Risk Reduction (RRR)|76.84||||0.0002|TWO_SIDED|95.0|49.36|89.41|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||89.41|49.36|0.0002
91719065|NCT03183908|183331110|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 5%, stratified by site.|Difference in proportions|-2.7|||||TWO_SIDED|95.0|-5.8|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|The null hypothesis is allV3 is inferior (i.e., allV3 will have higher rates of moderate/severe injection site pain) to IIV3-HD in regards to the proportion of subjects having moderate or severe injection site pain in the first week post vaccination.||0.4|-5.8|
91719066|NCT03183908|183331112|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|2.38|||||TWO_SIDED|95.0|1.09|4.47||||||||4.47|1.09|
91719067|NCT03183908|183331112|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|0.79|||||TWO_SIDED|95.0|0.16|2.23||||||||2.23|0.16|
91719068|NCT03183908|183331113|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 and noninferiority margin of 10%. The null hypothesis is the allV3 H3N2 seroconversion rate is inferior to IIV3-HD seroconversion rate.|Difference in Proportions|-0.0579||||0.1245|ONE_SIDED|97.5|-0.1291||||Cochran-Mantel-Haenszel||The directional comparison was the lower bound of the confidence interval using a 10% non-inferiority margin.||||-.1291|0.1245
91719069|NCT03183908|183331114|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.9|||||TWO_SIDED|98.0|-5.0|1.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||1.0|-5.0|
91684047|NCT03713619|183258804|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0418|TWO_SIDED|95.0|0.95|2.32|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.32|0.95|0.0418
91684048|NCT03713619|183258805|SUPERIORITY||Least square Mean Difference|-23.05|||<|0.0001|TWO_SIDED|95.0|-33.9|-12.21|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-12.21|-33.90|<0.0001
91684049|NCT03713619|183258805|SUPERIORITY||Least Square Mean difference|-18.46||||0.0004|TWO_SIDED|95.0|-29.32|-7.6|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-7.60|-29.32|0.0004
91684050|NCT03713619|183258806|SUPERIORITY||Odds Ratio, log|0.42||||0.001|TWO_SIDED|95.0|0.25|0.73|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||0.73|0.25|0.0010
91684051|NCT03713619|183258806|SUPERIORITY||Odds Ratio (OR)|0.71||||0.0926|TWO_SIDED|95.0|0.43|1.17|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||1.17|0.43|0.0926
91684052|NCT03713619|183258807|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0248|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||3.40|1.00|0.0248
91684053|NCT03713619|183258807|SUPERIORITY||Odds Ratio, log|1.77||||0.0044|TWO_SIDED|95.0|1.15|2.0|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||2.0|1.15|0.0044
91684054|NCT02552212|183258823|OTHER||Odds Ratio (OR)|15.231|||<|0.001|TWO_SIDED|95.0|7.336|31.623|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and Magnetic Resonance Imaging/C- Reactive Protein (MRI/CRP) classification.||31.623|7.336|<0.001
91684055|NCT02552212|183258824|OTHER||Odds Ratio (OR)|7.436|||<|0.001|TWO_SIDED|95.0|4.127|13.401|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||13.401|4.127|<0.001
91684056|NCT02552212|183258834|OTHER||Odds Ratio (OR)|7.359|||<|0.001|TWO_SIDED|95.0|4.286|12.636|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.||12.636|4.286|<0.001
91684057|NCT02552212|183258835|OTHER||Difference|-1.696|||<|0.001|TWO_SIDED|95.0|-2.11|-1.282|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.282|-2.110|<0.001
91684058|NCT02552212|183258836|OTHER||Difference|-1.585|||<|0.0001|TWO_SIDED|95.0|-2.132|-1.038|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.038|-2.132|<0.0001
91684059|NCT02552212|183258837|OTHER||Difference|-1.819|||<|0.001|TWO_SIDED|95.0|-2.25|-1.388|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.388|-2.250|<0.001
91684060|NCT02552212|183258838|OTHER||Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.909|-0.672|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.672|-1.909|<0.001
91684061|NCT02552212|183258839|OTHER||Difference|-4.8687|||<|0.001|TWO_SIDED|95.0|-6.4014|-3.336|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-3.3360|-6.4014|<0.001
91684062|NCT02552212|183258840|OTHER||Odds Ratio (OR)|6.223|||<|0.001|TWO_SIDED|95.0|3.8|10.191|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||10.191|3.800|<0.001
91684063|NCT02552212|183258841|OTHER||Difference|-0.183|||<|0.001|TWO_SIDED|95.0|-0.25|-0.117|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.117|-0.250|<0.001
91684064|NCT02552212|183258849|OTHER||Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.62|-1.18|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.18|-2.62|<0.001
91684065|NCT02552212|183258850|OTHER||Odds Ratio (OR)|0.484|||=|0.247|TWO_SIDED|95.0|0.142|1.653|||Regression, Logistic|||Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||1.653|0.142|=0.247
91684066|NCT03020589|183258854|SUPERIORITY||Risk Ratio (RR)|1.27||||0.58|TWO_SIDED|95.0|0.67|2.05|||Fisher Exact|||||2.05|0.67|0.58
91684067|NCT03020589|183258855|SUPERIORITY||Risk Ratio (RR)|1.26||||0.46|TWO_SIDED|95.0|0.72|2.02|||Fisher Exact|||||2.02|0.72|0.46
91684068|NCT01094886|183258862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.5||0.008|TWO_SIDED|95.0|-0.05|0.34|||t-test, 2 sided|||||0.34|-0.05|.008
91684069|NCT01094886|183258863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_DEVIATION|-1.1||0.111|TWO_SIDED|95.0|-2.048|0.219|||t-test, 2 sided|||||0.219|-2.048|0.111
91684070|NCT01094886|183258864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|6.977||0.87|TWO_SIDED|95.0|-2.77|2.35|||t-test, 2 sided|||||2.35|-2.77|0.87
91684071|NCT01094886|183258865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.13|STANDARD_DEVIATION|36.316|<|0.001|TWO_SIDED|95.0|-48.01|-22.26|||t-test, 2 sided|||||-22.26|-48.01|<0.001
91684072|NCT02092467|183258910|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.04|2.09|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||2.09|1.04|
91719070|NCT03183908|183331114|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.3|-3.1|
91684073|NCT02092467|183258910|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.43|||||Secondary comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \< 2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.43|0.70|
91684074|NCT02092467|183258910|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|1.0|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||2.18|1.00|
91684075|NCT02092467|183258910|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.0|2.19|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.19|1.00|
91684076|NCT02092467|183258911|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.91|1.94|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||1.94|0.91|
91684077|NCT02092467|183258911|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.77|1.71|||||Secondary Comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \<2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.71|0.77|
91684078|NCT02092467|183258911|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.81|1.91|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||1.91|0.81|
91684079|NCT02092467|183258911|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.94|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.18|0.94|
91684080|NCT01284621|183258934|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|96.55|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|93.05|100.18|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||100.18|93.05|
91684081|NCT01284621|183258935|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|104.47|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|97.65|111.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||111.77|97.65|
91684082|NCT01284621|183258936|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|108.14|STANDARD_DEVIATION|14.0|||TWO_SIDED|90.0|100.51|116.35|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||116.35|100.51|
91684083|NCT01284621|183258937|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|103.61|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|89.73|119.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||119.64|89.73|
91684084|NCT01284621|183258938|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|98.67|STANDARD_DEVIATION|5.2|||TWO_SIDED|90.0|96.0|101.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||101.42|96.00|
91684085|NCT01284621|183258939|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|98.29|STANDARD_DEVIATION|11.3|||TWO_SIDED|90.0|92.67|104.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||104.25|92.67|
91684086|NCT02293863|183258997|OTHER||Hazard Ratio (HR)|1.08||||0.605|TWO_SIDED|80.0|0.83|1.4|||Wilcoxon (Mann-Whitney)|||||1.40|0.83|0.6050
91719071|NCT03183908|183331114|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-3.7|||||TWO_SIDED|98.0|-7.5|-0.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-0.3|-7.5|
91684087|NCT02293863|183258997|OTHER||Hazard Ratio (HR)|1.13||||0.2028|TWO_SIDED|80.0|0.85|1.51|||Wilcoxon (Mann-Whitney)|||||1.51|0.85|0.2028
91684088|NCT02293863|183258999|OTHER||Difference in event rates|10.19||||0.1905|TWO_SIDED|80.0|-0.15|20.52|||Cochran-Mantel-Haenszel|||||20.52|-0.15|0.1905
91719072|NCT03183908|183331114|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.6|||||TWO_SIDED|98.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
91684089|NCT02293863|183258999|OTHER||Difference in event rates|7.91||||0.3168|TWO_SIDED|80.0|-2.64|18.47|||Cochran-Mantel-Haenszel|||||18.47|-2.64|0.3168
91684090|NCT02293863|183259000|OTHER||Difference in event rates|-7.92||||0.6043|TWO_SIDED|80.0|-27.5|11.66|||Cochran-Mantel-Haenszel|||||11.66|-27.50|0.6043
91719073|NCT03183908|183331115|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-5.2|0.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||0.2|-5.2|
91719074|NCT03183908|183331115|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.9|-2.3|
91719075|NCT03183908|183331115|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-4.5|||||TWO_SIDED|95.0|-8.1|-1.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-1.1|-8.1|
91719076|NCT03183908|183331115|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
91719077|NCT03183908|183331115|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-3.1|||||TWO_SIDED|95.0|-6.9|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||0.4|-6.9|
91719078|NCT03183908|183331116|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||7.3|-7.3|
91719079|NCT03183908|183331116|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.5|5.7|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||5.7|-9.5|
91719080|NCT03183908|183331116|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.6|6.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||6.1|-8.6|
91719081|NCT03183908|183331116|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.7|8.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||8.3|-5.7|
91719082|NCT03183908|183331116|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||5.4|-7.9|
91487358|NCT02642029|182847276|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexcTBS interact|-0.0757|STANDARD_ERROR_OF_MEAN|0.052||0.143|TWO_SIDED|95.0|-0.177|0.0256||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the cTBS (vs. sham) x time interaction.||.0256|-.1770|0.143
91526892|NCT00007475|182929348|SUPERIORITY_OR_OTHER||Proportion with reduced proteinuria|0.6363|STANDARD_ERROR_OF_MEAN|0.0698|<|0.0001|TWO_SIDED|95.0|0.3079|0.8907||Exact binomial test of proportion of participants exhibiting reduction in proteinuria (see definition below), under null hypothesis that the overall proportion is zero.|Exact binomial test|Tested under null hypothesis that the overall proportion is zero.|Proportion event definition: exhibiting reduction in proteinuria post-cyclophosphamide (complete- \[urine protein {UP} \<0.3\] or or partial-remission \[between 0.3 \& 2.0, inclusive\], limited response \[UP between 2.0 \& 3.5\] yet no relapse \[UP 3.5+\]).|No groups compared, yet null hypothesis: pooled proportion = 0, tested using counts pooled across baseline FPF assay-availability groups (7 across 3 arms) excluding 4 non-completers (yielding 7/11 with event below). Given the modest group-specific sample sizes and tendency for zero outcomes to be observed in a group, we employ exact binomial 95% confidence intervals using the method of Clopper and Pearson (1934; calculated along with corresponding tests using Michael Fay's exactci package in R).||0.8907|0.3079|<0.0001
91719083|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.4|-1.7|
91719084|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.5|||||TWO_SIDED|98.0|-2.8|2.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.3|-2.8|
91719085|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.1|||||TWO_SIDED|98.0|-4.0|1.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.5|-4.0|
91719086|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|3.2|||||TWO_SIDED|98.0|-0.8|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.3|-0.8|
91719087|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-2.5|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||2.0|-2.5|
91526893|NCT00737061|182929359|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.9|100.0||||||1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||100|97.9|
91526894|NCT00737061|182929359|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.6|99.5||||||2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||99.5|97.6|
91526895|NCT00737061|182929369|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|97.2|100.0||||No statistical hypothesis testing was performed.||"1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||100|97.2|
91526896|NCT00737061|182929369|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|96.9|99.1||||No statistical hypothesis testing was performed.||"2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||99.1|96.9|
91526897|NCT00692406|182929392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0023|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526898|NCT00692406|182929393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1167|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526899|NCT00692406|182929394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0253|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526900|NCT00692406|182929395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1432|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526901|NCT00692406|182929396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0489|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526902|NCT00692406|182929397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0096|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526903|NCT00692406|182929398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0372|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526904|NCT00692406|182929399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
91526905|NCT01407354|182929416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
91526906|NCT01407354|182929416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|threshold p value for statistical significance=0.05||||||0.024
91526907|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.0||||0.4788|TWO_SIDED|95.0|-284.8|134.9|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 1||134.9|-284.8|0.4788
91526908|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.1||||0.2309|TWO_SIDED|95.0|-80.6|328.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 1||328.9|-80.6|0.2309
91526909|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-185.1||||0.0758|TWO_SIDED|95.0|-389.8|19.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 1||19.7|-389.8|0.0758
91526910|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Median Difference (Net)|130.4||||0.2084|TWO_SIDED|95.0|-74.4|335.1|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 1||335.1|-74.4|0.2084
91526911|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|132.6||||0.1684|TWO_SIDED|95.0|-57.4|322.6|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 1||322.6|-57.4|0.1684
91526912|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-90.4||||0.5122|TWO_SIDED|95.0|-364.7|184.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 2||184.0|-364.7|0.5122
91526913|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.5||||0.5417|TWO_SIDED|95.0|-321.7|170.7|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 2||170.7|-321.7|0.5417
91526914|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.4||||0.6511|TWO_SIDED|95.0|-294.2|185.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 2||185.3|-294.2|0.6511
91526915|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.7||||0.6117|TWO_SIDED|95.0|-189.1|318.5|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 2||318.5|-189.1|0.6117
91526916|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-99.7||||0.3882|TWO_SIDED|95.0|-329.3|129.9|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 2||129.9|-329.3|0.3882
91684091|NCT02293863|183259000|OTHER||Difference in event rates|-14.58||||0.3865|TWO_SIDED|80.0|-36.13|6.97|||Cochran-Mantel-Haenszel|||||6.97|-36.13|0.3865
91684092|NCT02293863|183259001|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||Day 14||9.56|-5.57|0.5379
91684093|NCT02293863|183259001|OTHER||Difference in event rates|4.97||||0.2189|TWO_SIDED|80.0|-3.12|13.05|||Cochran-Mantel-Haenszel|||Day 14||13.05|-3.12|0.2189
91684094|NCT02293863|183259001|OTHER||Difference in event rates|2.14||||0.6594|TWO_SIDED|80.0|-6.04|10.31|||Cochran-Mantel-Haenszel|||Day 30||10.31|-6.04|0.6594
91684095|NCT02293863|183259001|OTHER||Difference in event rates|3.54||||0.5013|TWO_SIDED|80.0|-5.24|12.31|||Cochran-Mantel-Haenszel|||Day 30||12.31|-5.24|0.5013
91684096|NCT02293863|183259001|OTHER||Difference in event rates|2.21||||0.6849|TWO_SIDED|80.0|-6.28|10.69|||Cochran-Mantel-Haenszel|||Day 60||10.69|-6.28|0.6849
91526917|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.5||||0.4781|TWO_SIDED|95.0|-477.5|226.5|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH effect||226.5|-477.5|0.4781
91684097|NCT02293863|183259001|OTHER||Difference in event rates|1.68||||0.7633|TWO_SIDED|80.0|-7.38|10.74|||Cochran-Mantel-Haenszel|||Day 60||10.74|-7.38|0.7633
91684098|NCT02293863|183259002|OTHER||Mean Difference (Final Values)|-3.73||||0.2407|TWO_SIDED|80.0|-6.41|-1.06|||ANOVA|||||-1.06|-6.41|0.2407
91684099|NCT02293863|183259002|OTHER||Mean Difference (Final Values)|-0.7||||0.8339|TWO_SIDED|80.0|-3.49|2.1|||ANOVA|||||2.10|-3.49|0.8339
91684100|NCT02293863|183259003|OTHER||Mean Difference (Final Values)|-0.33||||0.279|TWO_SIDED|80.0|-0.6|-0.07|||ANOVA|||||-0.07|-0.60|0.2790
91684101|NCT02293863|183259003|OTHER||Mean Difference (Final Values)|-0.42||||0.1909|TWO_SIDED|80.0|-0.7|-0.15|||ANOVA|||||-0.15|-0.70|0.1909
91684102|NCT02293863|183259004|OTHER||Hazard Ratio (HR)|1.01||||0.7413|TWO_SIDED|80.0|0.77|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.77|0.7413
91684103|NCT02293863|183259004|OTHER||Hazard Ratio (HR)|1.32||||0.4763|TWO_SIDED|80.0|0.99|1.77|||Wilcoxon (Mann-Whitney)|||||1.77|0.99|0.4763
91684104|NCT02293863|183259005|OTHER||Hazard Ratio (HR)|1.01||||0.8806|TWO_SIDED|80.0|0.78|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.78|0.8806
91684105|NCT02293863|183259005|OTHER||Hazard Ratio (HR)|1.05||||0.5447|TWO_SIDED|80.0|0.8|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.80|0.5447
91684106|NCT02293863|183259006|OTHER||Hazard Ratio (HR)|0.7||||0.4171|TWO_SIDED|80.0|0.47|1.03|||Wilcoxon (Mann-Whitney)|||||1.03|0.47|0.4171
91684107|NCT02293863|183259006|OTHER||Hazard Ratio (HR)|0.9||||0.8322|TWO_SIDED|80.0|0.61|1.34|||Wilcoxon (Mann-Whitney)|||||1.34|0.61|0.8322
91684108|NCT02293863|183259007|OTHER||Difference in event rates|-1.42||||0.824|TWO_SIDED|80.0|-10.61|7.76|||Cochran-Mantel-Haenszel|||||7.76|-10.61|0.8240
91684109|NCT02293863|183259007|OTHER||Difference in event rates|-1.6||||0.8111|TWO_SIDED|80.0|-11.48|8.28|||Cochran-Mantel-Haenszel|||||8.28|-11.48|0.8111
91684110|NCT02293863|183259008|OTHER||Difference in event rates|2.42||||0.7219|TWO_SIDED|80.0|-6.96|11.8|||Cochran-Mantel-Haenszel|||||11.80|-6.96|0.7219
91684111|NCT02293863|183259008|OTHER||Difference in event rates|0.67||||0.9225|TWO_SIDED|80.0|-9.29|10.64|||Cochran-Mantel-Haenszel|||||10.64|-9.29|0.9225
91684112|NCT02293863|183259009|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||||9.56|-5.57|0.5379
91684113|NCT02293863|183259009|OTHER||Difference in event rates|-1.85||||0.3667|TWO_SIDED|80.0|-9.88|6.18|||Cochran-Mantel-Haenszel|||||6.18|-9.88|0.3667
91684114|NCT02293863|183259010|OTHER||Hazard Ratio (HR)|0.66||||0.7827|TWO_SIDED|80.0|0.41|1.07|||Wilcoxon (Mann-Whitney)|||||1.07|0.41|0.7827
91684115|NCT02293863|183259010|OTHER||Hazard Ratio (HR)|0.58||||0.2522|TWO_SIDED|80.0|0.36|0.96|||Wilcoxon (Mann-Whitney)|||||0.96|0.36|0.2522
91684116|NCT00213135|183259084|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.35|0.54|||Wald Chi-square test|||||0.54|0.35|<0.001
91684117|NCT00213135|183259084|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.34|0.54|||Wald Chi-square test|||||0.54|0.34|<0.001
91684118|NCT01328379|183259088|SUPERIORITY_OR_OTHER||least squares mean|0.054|STANDARD_ERROR_OF_MEAN|0.0724||0.457|TWO_SIDED|95.0|-0.088|0.196||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.196|-0.088|0.457
91684119|NCT01328379|183259088|SUPERIORITY_OR_OTHER||least squares mean|0.118|STANDARD_ERROR_OF_MEAN|0.0732||0.107|TWO_SIDED|95.0|-0.026|0.262|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.262|-0.026|0.107
91684120|NCT01328379|183259088|SUPERIORITY_OR_OTHER||least squares mean|0.064|STANDARD_ERROR_OF_MEAN|0.0724||0.375|TWO_SIDED|95.0|-0.078|0.207|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.207|-0.078|0.375
91526918|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-277.9||||0.0834|TWO_SIDED|95.0|-593.7|37.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH effect||37.9|-593.7|0.0834
91684121|NCT01328379|183259089|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0666||0.832|TWO_SIDED|95.0|-0.145|0.117||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.117|-0.145|0.832
91684122|NCT01328379|183259089|SUPERIORITY_OR_OTHER||Least Squares Mean|0.093|STANDARD_ERROR_OF_MEAN|0.0674||0.167|TWO_SIDED|95.0|-0.039|0.226|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.226|-0.039|0.167
91684123|NCT01328379|183259089|SUPERIORITY_OR_OTHER||Least Squares Mean|0.107|STANDARD_ERROR_OF_MEAN|0.0666||0.108|TWO_SIDED|95.0|-0.024|0.238|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.238|-0.024|0.108
91684124|NCT01328379|183259090|SUPERIORITY_OR_OTHER||Lease Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|2.367||0.866|TWO_SIDED|95.0|-5.05|4.25|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||4.25|-5.05|0.866
91684125|NCT01328379|183259090|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.56|STANDARD_ERROR_OF_MEAN|2.393||0.286|TWO_SIDED|95.0|-7.26|2.15|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||2.15|-7.26|0.286
91684126|NCT01328379|183259090|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.16|STANDARD_ERROR_OF_MEAN|2.366||0.362|TWO_SIDED|95.0|-6.81|2.49|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 3||2.49|-6.81|0.362
91684127|NCT01328379|183259091|SUPERIORITY_OR_OTHER||Least Squares Mean|0.84|STANDARD_ERROR_OF_MEAN|2.237||0.708|TWO_SIDED|95.0|-3.56|5.24|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||5.24|-3.56|0.708
91684128|NCT01328379|183259091|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.38|STANDARD_ERROR_OF_MEAN|2.258||0.868|TWO_SIDED|95.0|-4.81|4.06|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||4.06|-4.81|0.868
91684129|NCT01328379|183259091|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.21|STANDARD_ERROR_OF_MEAN|2.236||0.588|TWO_SIDED|95.0|-5.61|3.18|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 2||3.18|-5.61|0.588
91684130|NCT01328379|183259092|SUPERIORITY_OR_OTHER||Least Squares Mean|35.4|STANDARD_ERROR_OF_MEAN|34.57||0.308|TWO_SIDED|95.0|-33.0|103.7|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||103.7|-33.0|0.308
91684131|NCT01328379|183259092|SUPERIORITY_OR_OTHER||Least Squares Mean|87.1|STANDARD_ERROR_OF_MEAN|34.9||0.014|TWO_SIDED|95.0|18.2|156.1|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||156.1|18.2|0.014
91684132|NCT01328379|183259092|SUPERIORITY_OR_OTHER||Least Squares Mean|51.7|STANDARD_ERROR_OF_MEAN|34.21||0.133|TWO_SIDED|95.0|-15.9|119.3|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||119.3|-15.9|0.133
91684133|NCT01328379|183259093|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.32|TWO_SIDED|95.0|0.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.1|-0.0|0.320
91684134|NCT01328379|183259093|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.734|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.734
91684135|NCT01328379|183259093|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.185|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.185
91719088|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.3|||||TWO_SIDED|98.0|-3.0|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.0|
91487359|NCT02642029|182847277|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-0.0446||||0.626|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||.626
91526919|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|121.7||||0.4313|TWO_SIDED|95.0|-185.8|429.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH effect||429.3|-185.8|0.4313
91684136|NCT01328379|183259094|SUPERIORITY_OR_OTHER||Least Squares Mean|-3.4|STANDARD_ERROR_OF_MEAN|1.79||0.055|TWO_SIDED|95.0|-7.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||0.1|-7.0|0.055
91684137|NCT01328379|183259094|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.83||0.53|TWO_SIDED|95.0|-4.7|2.4|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||2.4|-4.7|0.530
91526920|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-73.5||||0.6528|TWO_SIDED|95.0|-399.1|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH effect||252.0|-399.1|0.6528
91526921|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.5||||0.0966|TWO_SIDED|95.0|-542.9|46.0|||Mixed Models Analysis|||Placebo versus Asacol for ACTH effect||46.0|-542.9|0.0966
91684138|NCT01328379|183259094|SUPERIORITY_OR_OTHER||Least Squares Mean|2.3|STANDARD_ERROR_OF_MEAN|1.8||0.203|TWO_SIDED|95.0|-1.2|5.8|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in EQ-5D VAS score at Visit 3||5.8|-1.2|0.203
91684139|NCT03452137|183259148|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6804|TWO_SIDED|95.0|0.7|1.26|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, human papillomavirus (HPV) status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.26|0.70|0.6804
91684140|NCT03452137|183259149|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8371|TWO_SIDED|95.0|0.68|1.36|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.36|0.68|0.8371
91684141|NCT03452137|183259150|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.73|1.32|||Log Rank||HR was estimated by Cox regression|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.32|0.73|0.9115
91684142|NCT03452137|183259151|SUPERIORITY||Difference in Event Free Rate|-0.67||||0.8816|TWO_SIDED|95.0|-9.45|8.11|||Z test|||Difference in EFS Event-Free Rates at 1 year||8.11|-9.45|0.8816
91684143|NCT03452137|183259151|SUPERIORITY||Difference in Event Free Rate|0.46||||0.9234|TWO_SIDED|95.0|-8.86|9.78|||Z test|||Difference in EFS Event-Free Rates at 2 years||9.78|-8.86|0.9234
91684144|NCT03452137|183259151|SUPERIORITY||Difference in Event Free Rate|1.19||||0.809|TWO_SIDED|95.0|-8.49|10.88|||Z test|||Difference in EFS Event-Free Rates at 3 years||10.88|-8.49|0.8090
91684145|NCT03452137|183259151|SUPERIORITY||Difference in Event Free Rate|0.01||||0.9985|TWO_SIDED|95.0|-10.17|10.19|||Z test|||Difference in EFS Event-Free Rates at 4 years||10.19|-10.17|0.9985
91684146|NCT03452137|183259152|SUPERIORITY||Difference in Event Free Rate|5.17||||0.2393|TWO_SIDED|95.0|-3.44|13.79|||Z test|||Difference in EFS Event-Free Rates at 1 year||13.79|-3.44|0.2393
91684147|NCT03452137|183259152|SUPERIORITY||Difference in Event Free Rate|3.61||||0.4472|TWO_SIDED|95.0|-5.69|12.9|||Z test|||Difference in EFS Event-Free Rates at 2 years||12.90|-5.69|0.4472
91684148|NCT03452137|183259152|SUPERIORITY||Difference in Event Free Rate|3.14||||0.5222|TWO_SIDED|95.0|-6.49|12.77|||Z test|||Difference in EFS Event-Free Rates at 3 years||12.77|-6.49|0.5222
91684149|NCT03452137|183259152|SUPERIORITY||Difference in Event Free Rate|1.31||||0.7967|TWO_SIDED|95.0|-8.64|11.26|||Z test|||Difference in EFS Event-Free Rates at 4 years||11.26|-8.64|0.7967
91684150|NCT03452137|183259153|SUPERIORITY||Difference in Event Free Rate|2.77||||0.4819|TWO_SIDED|95.0|-4.95|10.49|||Z test|||Difference in OS Event-Free Rates at 2 years||10.49|-4.95|0.4819
91684151|NCT03452137|183259153|SUPERIORITY||Difference in Event Free Rate|-1.25||||0.7783|TWO_SIDED|95.0|-9.97|7.47|||Z test|||Difference in OS Event-Free Rates at 3 years||7.47|-9.97|0.7783
91684152|NCT03452137|183259153|SUPERIORITY||Difference in Event Free Rate|-1.07||||0.8924|TWO_SIDED|95.0|-16.56|14.42|||Z test|||Difference in OS Event-Free Rates at 5 years||14.42|-16.56|0.8924
91684153|NCT02856802|183259159|NON_INFERIORITY|Assumption that 15% of placebo and 42% of DFN 02 10 mg (treated) subjects would be pain-free at 2 hours. A sample size of 50 subjects in each DB1 dosing arm provided 86% power to detect this assumed difference between placebo and DFN-02 10 mg at a 5% (2-sided) level of significance.|Odds Ratio (OR)|2.68||||0.044|TWO_SIDED|95.0|1.05|6.83|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the statistical analysis system (SAS)® software package (version 9.3).||6.83|1.05|0.044
91684154|NCT02856802|183259160|NON_INFERIORITY|Non-inferiority conducted as specified in the statistical analysis plan (SAP).||||||0.007||||||The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups.|Fisher Exact|||||||0.007
91684155|NCT02856802|183259161|NON_INFERIORITY|No assumptions made.|Odds Ratio (OR)|1.31||||0.642|TWO_SIDED|95.0|0.52|3.3|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the SAS® software package (version 9.3).||3.30|0.52|0.642
91684156|NCT00261443|183259199|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.544||||0.014|TWO_SIDED|95.0|0.332|0.893||Stratified Log-rank Test, controlling for type of mood stabilizer and type of mood episode|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.893|0.332|0.014
91684157|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.911|TWO_SIDED|95.0|-0.16|0.15||ANOVA model, controlling for treatment, mood stabilizer, and index mood episode used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value used for mean change from baseline.|ANOVA/ANCOVA|Means, difference in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.15|-0.16|0.911
91684158|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.557|TWO_SIDED|95.0|-0.09|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.18|-0.09|0.557
91684159|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.596|TWO_SIDED|95.0|-0.18|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.18|0.596
91719089|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||5.4|-1.7|
91526922|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.2||||0.7704|TWO_SIDED|95.0|-187.6|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH morning||252.0|-187.6|0.7704
91684160|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.05||||0.522|TWO_SIDED|95.0|-0.22|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.11|-0.22|0.522
91684161|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.142|TWO_SIDED|95.0|-0.3|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.04|-0.30|0.142
91684162|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.16||||0.092|TWO_SIDED|95.0|-0.35|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.03|-0.35|0.092
91684163|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.039|TWO_SIDED|95.0|-0.4|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.01|-0.40|0.039
91684164|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.05|TWO_SIDED|95.0|-0.43|0.0||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.00|-0.43|0.050
91684165|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.064|TWO_SIDED|95.0|-0.4|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.40|0.064
91684166|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.25||||0.017|TWO_SIDED|95.0|-0.46|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.05|-0.46|0.017
91684167|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.039|TWO_SIDED|95.0|-0.43|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.01|-0.43|0.039
91684168|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.015|TWO_SIDED|95.0|-0.48|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.05|-0.48|0.015
91684169|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.009|TWO_SIDED|95.0|-0.5|-0.07||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.07|-0.50|0.009
91684170|NCT00261443|183259200|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.28||||0.013|TWO_SIDED|95.0|-0.5|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.50|0.013
91719090|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.3|4.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.4|-3.3|
91719091|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.8|||||TWO_SIDED|98.0|-3.1|1.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.6|-3.1|
91719092|NCT03183908|183331117|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.0|||||TWO_SIDED|98.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
91526923|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|165.3||||0.0988|TWO_SIDED|95.0|-32.0|362.5|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH morning||362.5|-32.0|0.0988
91719093|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.1|5.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.8|-1.1|
91526924|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-153.4||||0.1153|TWO_SIDED|95.0|-345.5|38.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH morning||38.7|-345.5|0.1153
91684171|NCT00261443|183259201|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348||||0.013|TWO_SIDED|95.0|0.146|0.829||Stratified Log-rank Test, controlling for type of mood stabilizer and type of index mood episode.|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.829|0.146|0.013
91684172|NCT00261443|183259202|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.733||||0.384|TWO_SIDED|95.0|0.364|1.479||Stratified Log-rank Test P-value for Equality of Survival Curves|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||1.479|0.364|0.384
91684173|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.955|TWO_SIDED|95.0|-0.73|0.77||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.77|-0.73|0.955
91684174|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.06||||0.895|TWO_SIDED|95.0|-0.83|0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.95|-0.83|0.895
91684175|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.69||||0.144|TWO_SIDED|95.0|-1.61|0.24||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.24|-1.61|0.144
91684176|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.1||||0.047|TWO_SIDED|95.0|-2.19|-0.01||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||-0.01|-2.19|0.047
91684177|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.39||||0.017|TWO_SIDED|95.0|-2.52|-0.25||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||-0.25|-2.52|0.017
91684178|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.68||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||-0.68|-3.15|0.003
91684179|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.18|||<|0.001|TWO_SIDED|95.0|-3.47|-0.89||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.89|-3.47|<0.001
91684180|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.62|||<|0.001|TWO_SIDED|95.0|-4.06|-1.19||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-1.19|-4.06|<0.001
91684181|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.7|-0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.95|-3.70|<0.001
91526925|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.7||||0.9636|TWO_SIDED|95.0|-198.7|208.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH morning||208.0|-198.7|0.9636
91719094|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.0|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.0|-3.0|
91526926|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|119.8||||0.1972|TWO_SIDED|95.0|-64.1|303.8|||Mixed Models Analysis|||Placebo versus Asacol for ACTH morning||303.8|-64.1|0.1972
91684182|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.78|||<|0.001|TWO_SIDED|95.0|-4.19|-1.37||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-1.37|-4.19|<0.001
91684183|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-4.13|-1.29||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-1.29|-4.13|<0.001
91684184|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.38|-1.46||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-1.46|-4.38|<0.001
91684185|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.08|||<|0.001|TWO_SIDED|95.0|-4.59|-1.57||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-1.57|-4.59|<0.001
91684186|NCT00261443|183259204|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.04|||<|0.001|TWO_SIDED|95.0|-4.55|-1.54||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-1.54|-4.55|<0.001
91684187|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.2||||0.59|TWO_SIDED|95.0|-0.54|0.94||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.94|-0.54|0.590
91684188|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.5||||0.371|TWO_SIDED|95.0|-1.59|0.6||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.60|-1.59|0.371
91684189|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.04||||0.113|TWO_SIDED|95.0|-2.33|0.25||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.25|-2.33|0.113
91684190|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.0||||0.128|TWO_SIDED|95.0|-2.28|0.29||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.29|-2.28|0.128
91684191|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.85||||0.205|TWO_SIDED|95.0|-2.16|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.47|-2.16|0.205
91684192|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.13||||0.125|TWO_SIDED|95.0|-2.59|0.32||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.32|-2.59|0.125
91684193|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.43||||0.061|TWO_SIDED|95.0|-2.92|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.06|-2.92|0.061
91684194|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.51||||0.06|TWO_SIDED|95.0|-3.07|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.06|-3.07|0.060
91684195|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.62||||0.046|TWO_SIDED|95.0|-3.21|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.03|-3.21|0.046
91684196|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.15||||0.164|TWO_SIDED|95.0|-2.77|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.47|-2.77|0.164
91719095|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.5|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.8|-3.5|
91526927|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-207.6||||0.0495|TWO_SIDED|95.0|-414.6|-0.5|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 1||-0.5|-414.6|0.0495
91684197|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.53||||0.066|TWO_SIDED|95.0|-3.16|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.10|-3.16|0.066
91684198|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.57||||0.066|TWO_SIDED|95.0|-3.24|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.10|-3.24|0.066
91684199|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.08||||0.014|TWO_SIDED|95.0|-3.73|-0.43||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.43|-3.73|0.014
91684200|NCT00261443|183259206|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.01||||0.019|TWO_SIDED|95.0|-3.68|-0.34||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.34|-3.68|0.019
91684201|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.05||||0.597|TWO_SIDED|95.0|-0.13|0.22||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.22|-0.13|0.597
91684202|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.838|TWO_SIDED|95.0|-0.17|0.21||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.21|-0.17|0.838
91684203|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.291|TWO_SIDED|95.0|-0.32|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.32|0.291
91684204|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.219|TWO_SIDED|95.0|-0.37|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.08|-0.37|0.219
91684205|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.133|TWO_SIDED|95.0|-0.41|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.05|-0.41|0.133
91684206|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.092|TWO_SIDED|95.0|-0.46|0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.04|-0.46|0.092
91684207|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.018|TWO_SIDED|95.0|-0.56|-0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.05|-0.56|0.018
91684208|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.029|TWO_SIDED|95.0|-0.56|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.56|0.029
91684209|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.024|TWO_SIDED|95.0|-0.57|-0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.04|-0.57|0.024
91684210|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.035|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.02|-0.56|0.035
91526928|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5||||0.9333|TWO_SIDED|95.0|-210.4|193.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 1||193.4|-210.4|0.9333
91684211|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.038|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.02|-0.56|0.038
91684212|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.07|-0.62|0.015
91684213|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.39||||0.006|TWO_SIDED|95.0|-0.67|-0.12||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.12|-0.67|0.006
91684214|NCT00261443|183259208|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.35||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.07|-0.62|0.015
91684215|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.588|TWO_SIDED|95.0|-0.09|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.16|-0.09|0.588
91684216|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.922|TWO_SIDED|95.0|-0.18|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.16|-0.18|0.922
91684217|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.266|TWO_SIDED|95.0|-0.3|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.08|-0.30|0.266
91684218|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.159|TWO_SIDED|95.0|-0.34|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.06|-0.34|0.159
91684219|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.305|TWO_SIDED|95.0|-0.31|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.10|-0.31|0.305
91684220|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.251|TWO_SIDED|95.0|-0.35|0.09||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.09|-0.35|0.251
91684221|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.05|-0.40|0.135
91684222|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.073|TWO_SIDED|95.0|-0.46|0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.02|-0.46|0.073
91684223|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.26||||0.034|TWO_SIDED|95.0|-0.5|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.02|-0.50|0.034
91684224|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.174|TWO_SIDED|95.0|-0.41|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.07|-0.41|0.174
91684225|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.132|TWO_SIDED|95.0|-0.43|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.06|-0.43|0.132
91684226|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.152|TWO_SIDED|95.0|-0.42|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.07|-0.42|0.152
91684227|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.23||||0.06|TWO_SIDED|95.0|-0.48|0.01||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.01|-0.48|0.060
91684228|NCT00261443|183259210|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.085|TWO_SIDED|95.0|-0.46|0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.46|0.085
91684229|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.774|TWO_SIDED|95.0|-0.25|0.33||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.33|-0.25|0.774
91684230|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.213|TWO_SIDED|95.0|-0.49|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.11|-0.49|0.213
91684231|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.465|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.20|-0.43|0.465
91684232|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.068|TWO_SIDED|95.0|-0.59|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.02|-0.59|0.068
91684233|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.095|TWO_SIDED|95.0|-0.58|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.05|-0.58|0.095
91684234|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.082|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.082
91684235|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.033|TWO_SIDED|95.0|-0.69|-0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.69|0.033
91684236|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.062|TWO_SIDED|95.0|-0.64|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.02|-0.64|0.062
91684237|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.43||||0.011|TWO_SIDED|95.0|-0.76|-0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.10|-0.76|0.011
91684238|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.027|TWO_SIDED|95.0|-0.7|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.04|-0.70|0.027
91684239|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.029|TWO_SIDED|95.0|-0.71|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.04|-0.71|0.029
91684240|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.022|TWO_SIDED|95.0|-0.74|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.06|-0.74|0.022
91684241|NCT00261443|183259213|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.023|TWO_SIDED|95.0|-0.75|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.75|0.023
91684242|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.09||||0.486|TWO_SIDED|95.0|-0.17|0.36||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.36|-0.17|0.486
91684243|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.793|TWO_SIDED|95.0|-0.3|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.23|-0.30|0.793
91684244|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.665|TWO_SIDED|95.0|-0.34|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.22|-0.34|0.665
91684245|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.65|TWO_SIDED|95.0|-0.35|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.22|-0.35|0.650
91684246|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.705|TWO_SIDED|95.0|-0.34|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.23|-0.34|0.705
91684247|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.08||||0.572|TWO_SIDED|95.0|-0.38|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.21|-0.38|0.572
91684248|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.418|TWO_SIDED|95.0|-0.43|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.18|-0.43|0.418
91684249|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.185|TWO_SIDED|95.0|-0.51|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.10|-0.51|0.185
91684250|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.1||||0.536|TWO_SIDED|95.0|-0.41|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.21|-0.41|0.536
91684251|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.637|TWO_SIDED|95.0|-0.39|0.24||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.24|-0.39|0.637
91684252|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.34|0.29||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.29|-0.34|0.875
91719096|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.1|7.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.0|-1.1|
91526929|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-317.7||||0.0025|TWO_SIDED|95.0|-519.6|-115.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 1||-115.8|-519.6|0.0025
91526930|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.9823|TWO_SIDED|95.0|-204.1|199.6|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 1||199.6|-204.1|0.9823
91684253|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.378|TWO_SIDED|95.0|-0.46|0.17||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.17|-0.46|0.378
91684254|NCT00261443|183259215|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.474|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.20|-0.43|0.474
91684255|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.488|TWO_SIDED|95.0|-0.19|0.4||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.40|-0.19|0.488
91684256|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.15||||0.349|TWO_SIDED|95.0|-0.46|0.16||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.16|-0.46|0.349
91684257|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.653|TWO_SIDED|95.0|-0.39|0.25||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.25|-0.39|0.653
91684258|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.24||||0.141|TWO_SIDED|95.0|-0.56|0.08||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.08|-0.56|0.141
91684259|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.196|TWO_SIDED|95.0|-0.54|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.11|-0.54|0.196
91684260|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.088|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.088
91684261|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.047|TWO_SIDED|95.0|-0.68|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.01|-0.68|0.047
91684262|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.057|TWO_SIDED|95.0|-0.67|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.67|0.057
91684263|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.063|TWO_SIDED|95.0|-0.68|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.02|-0.68|0.063
91684264|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.3||||0.091|TWO_SIDED|95.0|-0.65|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.05|-0.65|0.091
91526931|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||0.946|TWO_SIDED|95.0|-265.0|283.7|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 2||283.7|-265.0|0.9460
91526932|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.2||||0.8445|TWO_SIDED|95.0|-222.0|270.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 2||270.4|-222.0|0.8445
91719097|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.0|-0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||-0.4|-3.0|
91719098|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.2|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.2|
91719099|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||4.5|-2.5|
91719100|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.3|-3.1|
91719101|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.3|-3.3|
91487360|NCT02642029|182847277|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-0.0903||||0.322|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.322
91487361|NCT02642029|182847278|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-9.797||||0.1118|TWO_SIDED|||||Significance threshold of p \< 0.05, two-sided|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||0.1118
91487362|NCT02642029|182847278|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-47.764||||9e-08|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.00000009
91719102|NCT03183908|183331118|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
91719103|NCT03183908|183331119|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.05|||||TWO_SIDED|95.0|-7.2|6.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||6.4|-7.2|
91719104|NCT03183908|183331119|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.1|-0.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||-0.6|-8.1|
91719105|NCT03183908|183331119|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.6|10.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||10.9|-3.6|
91526933|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.3||||0.7069|TWO_SIDED|95.0|-194.5|285.0|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 2||285.0|-194.5|0.7069
91684265|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.105|TWO_SIDED|95.0|-0.64|0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.06|-0.64|0.105
91684266|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.047|TWO_SIDED|95.0|-0.72|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.01|-0.72|0.047
91684267|NCT00261443|183259217|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.073|TWO_SIDED|95.0|-0.69|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.69|0.073
91684268|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.0||||0.91|TWO_SIDED|95.0|0.92|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 4||1.08|0.92|0.910
91684269|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.04||||0.3|TWO_SIDED|95.0|0.97|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 8||1.11|0.97|0.300
91684270|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.01||||0.744|TWO_SIDED|95.0|0.95|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 12||1.08|0.95|0.744
91684271|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.09||||0.015|TWO_SIDED|95.0|1.02|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 16||1.17|1.02|0.015
91684272|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.264|TWO_SIDED|95.0|0.97|1.14||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 20||1.14|0.97|0.264
91684273|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.09|TWO_SIDED|95.0|0.99|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 24||1.11|0.99|0.090
91684274|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.08||||0.056|TWO_SIDED|95.0|1.0|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 28||1.17|1.00|0.056
91684275|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|0.99||||0.756|TWO_SIDED|95.0|0.93|1.05||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 32||1.05|0.93|0.756
91684276|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.177|TWO_SIDED|95.0|0.98|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 36||1.13|0.98|0.177
91684277|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.021|TWO_SIDED|95.0|1.01|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 40||1.13|1.01|0.021
91684278|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.216|TWO_SIDED|95.0|0.96|1.16||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 44||1.16|0.96|0.216
91684279|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.017|TWO_SIDED|95.0|1.01|1.15||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 48||1.15|1.01|0.017
91684280|NCT00261443|183259218|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.083|TWO_SIDED|95.0|0.99|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 52||1.13|0.99|0.083
91684281|NCT00261443|183259219|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78||||0.132|TWO_SIDED|95.0|0.56|1.08|||Stratified Log Rank Test|Stratified Log Rank Test p-value for equality of survival curves.||||1.08|0.56|0.132
91684282|NCT00261443|183259260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.640
91684283|NCT00261443|183259260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.423
91684284|NCT00261443|183259260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.297
91684285|NCT00261443|183259260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.707
91684286|NCT00261443|183259261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.656
91684287|NCT00261443|183259261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.045
91719106|NCT03183908|183331119|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|6.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||6.6|-2.4|
91684288|NCT00261443|183259261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.532
91684289|NCT00261443|183259261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.578
91684290|NCT00261443|183259262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.619
91684291|NCT00261443|183259262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.868
91684292|NCT00261443|183259262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.284
91684293|NCT00261443|183259262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.481||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.481
91684294|NCT00261443|183259263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.184
91684295|NCT00261443|183259263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.073
91684296|NCT00261443|183259263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.020
91684297|NCT00261443|183259263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.206
91684298|NCT00261443|183259264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.142
91684299|NCT00261443|183259264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.110
91684300|NCT00261443|183259264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.022
91684301|NCT00261443|183259264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.542
91684302|NCT00261443|183259265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.916||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.916
91684303|NCT00261443|183259265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.707
91684304|NCT00261443|183259265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.665
91719107|NCT03183908|183331119|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|5.0|||||TWO_SIDED|95.0|2.0|12.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||12.2|2.0|
91719108|NCT03183908|183331119|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||7.3|-7.3|
91684305|NCT00261443|183259265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.757
91684306|NCT00261443|183259266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.871
91684307|NCT00261443|183259266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.362
91719109|NCT03183908|183331120|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5862|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.5862
91526934|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|164.4||||0.1998|TWO_SIDED|95.0|-89.4|418.2|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 2||418.2|-89.4|0.1998
91684308|NCT00261443|183259266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.295
91684309|NCT00261443|183259266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.519||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.519
91684310|NCT00261443|183259267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.935
91684311|NCT00261443|183259267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.174
91684312|NCT00261443|183259267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.527
91684313|NCT00261443|183259267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.753
91684314|NCT00261443|183259268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.850
91684315|NCT00261443|183259268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.709
91684316|NCT00261443|183259268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.326
91684317|NCT00261443|183259268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.201
91719110|NCT03183908|183331120|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5648|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5648
91684318|NCT00261443|183259269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47||||0.491|TWO_SIDED|95.0|-0.87|1.81||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 (LOCF) Treatment Difference||1.81|-0.87|0.491
91684319|NCT00261443|183259269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.945|TWO_SIDED|95.0|-1.21|1.12||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value Treatment Difference||1.12|-1.21|0.945
91684320|NCT00261443|183259270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.279
91684321|NCT00261443|183259270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.247||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.247
91684322|NCT00261443|183259270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.329
91684323|NCT00261443|183259270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.928||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.928
91684324|NCT00261443|183259270|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.584|TWO_SIDED|95.0|0.66|2.09||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||2.09|0.66|0.584
91684325|NCT00261443|183259270|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.26||||0.369|TWO_SIDED|95.0|0.76|2.08||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||2.08|0.76|0.369
91684326|NCT00261443|183259271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.685
91684327|NCT00261443|183259271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.792
91684328|NCT00261443|183259271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.805
91684329|NCT00261443|183259271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.533
91684330|NCT00261443|183259271|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.545|TWO_SIDED|95.0|0.35|1.74||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||1.74|0.35|0.545
91684331|NCT00261443|183259271|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01||||0.987|TWO_SIDED|95.0|0.54|1.86||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||1.86|0.54|0.987
91684332|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.646||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Treatment Comparison Baseline||||0.646
91684333|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 12 Treatment Comparison||||0.006
91684334|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 24 Treatment Comparison||||0.485
91684335|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 36 Treatment Comparison||||0.325
91684336|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 Treatment Comparison||||0.374
91684337|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 (LOCF) Treatment Comparison||||0.064
91684338|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Highest Value Treatment Comparison||||0.310
91684339|NCT00261443|183259272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Lowest Value Treatment Comparison||||0.046
91684340|NCT00261443|183259274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALP||||0.331
91684341|NCT00261443|183259274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)||||0.353
91684342|NCT00261443|183259274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.298||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALP Highest Change Value During Phase 3||||0.298
91684343|NCT00261443|183259275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALT||||0.111
91684344|NCT00261443|183259275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in ALT at Week 52 (LOCF)||||0.948
91684345|NCT00261443|183259275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALT Highest Change Value During Phase 3||||0.559
91684346|NCT00261443|183259276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline AST||||0.077
91684347|NCT00261443|183259276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in AST at Week 52 (LOCF)||||0.255
91684348|NCT00261443|183259276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.918||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison AST Highest Change Value During Phase 3||||0.918
91684349|NCT00261443|183259277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline BUN||||0.118
91684350|NCT00261443|183259277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)||||0.532
91487363|NCT02642029|182847279|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.91||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.910
91684351|NCT00261443|183259277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison BUN Highest Value of Change During Phase 3||||0.169
91684352|NCT00261443|183259278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Cholesterol (fasting)||||0.878
91684353|NCT00261443|183259278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)||||0.544
91684354|NCT00261443|183259278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.658||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3||||0.658
91684355|NCT00261443|183259279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatine Kinase||||0.043
91684356|NCT00261443|183259279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)||||0.019
91684357|NCT00261443|183259279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3||||0.176
91684358|NCT00261443|183259280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatinine||||0.105
91684359|NCT00261443|183259280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.634||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)||||0.634
91684360|NCT00261443|183259280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatinine During Phase 3||||0.958
91684361|NCT00261443|183259281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Eosinophils (relative)||||0.507
91684362|NCT00261443|183259281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.834||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)||||0.834
91684363|NCT00261443|183259281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.511||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3||||0.511
91684364|NCT00261443|183259282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Glucose (fasting)||||0.741
91684365|NCT00261443|183259282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.962||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)||||0.962
91684366|NCT00261443|183259282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3||||0.592
91684367|NCT00261443|183259283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hemoglobin||||0.080
91684368|NCT00261443|183259283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)||||0.868
91684369|NCT00261443|183259283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3||||0.299
91684370|NCT00261443|183259284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hematocrit||||0.187
91684371|NCT00261443|183259284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)||||0.377
91684372|NCT00261443|183259284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3||||0.494
91684373|NCT00261443|183259285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HDL Cholesterol (fasting)||||0.180
91684374|NCT00261443|183259285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)||||0.950
91684375|NCT00261443|183259285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3||||0.342
91684376|NCT00261443|183259286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-Percent Beta||||0.349
91684377|NCT00261443|183259286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.624||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)||||0.624
91684378|NCT00261443|183259286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3||||0.329
91684379|NCT00261443|183259287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-IR||||0.550
91684380|NCT00261443|183259287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)||||0.554
91684381|NCT00261443|183259287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample||||0.870
91684382|NCT00261443|183259288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.004
91684383|NCT00261443|183259288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.034
91684384|NCT00261443|183259288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3||||0.091
91684385|NCT00261443|183259289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline LDL Cholesterol (fasting)||||0.808
91684386|NCT00261443|183259289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.507
91684387|NCT00261443|183259289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)||||0.948
91684388|NCT00261443|183259290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.967||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Neutrophils (relative)||||0.967
91684389|NCT00261443|183259290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.486||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)||||0.486
91684390|NCT00261443|183259290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Sample||||0.323
91684391|NCT00261443|183259291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline in Platelet Count||||0.663
91684392|NCT00261443|183259291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.322
91684393|NCT00261443|183259291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.358||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.358
91684394|NCT00261443|183259291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.541||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.541
91684395|NCT00261443|183259292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.412||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Prolactin||||0.412
91684396|NCT00261443|183259292|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline at Week 52 (LOCF)||||<0.001
91684397|NCT00261443|183259292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Sample||||0.004
91684398|NCT00261443|183259293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Bilirubin||||0.630
91684399|NCT00261443|183259293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.675
91684400|NCT00261443|183259293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||||0.592
91684401|NCT00261443|183259294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Triglycerides (fasting)||||0.273
91526935|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|123.0||||0.4871|TWO_SIDED|95.0|-229.0|474.9|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH effect||474.9|-229.0|0.4871
91684402|NCT00261443|183259294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.489
91684403|NCT00261443|183259294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Sample||||0.415
91684404|NCT00261443|183259295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Uric Acid||||0.189
91684405|NCT00261443|183259295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.350
91684406|NCT00261443|183259295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Sample||||0.799
91684407|NCT00261443|183259296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.124||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Leukocytes||||0.124
91684408|NCT00261443|183259296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.295
91684409|NCT00261443|183259296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Highest Value of Change in Leukocytes, Phase 3||||0.735
91684410|NCT00261443|183259296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Lowest Value of Change in Leukocytes, Phase 3||||0.505
91526936|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.4||||0.8527|TWO_SIDED|95.0|-345.2|286.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH effect||286.4|-345.2|0.8527
91684411|NCT00261443|183259298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc Bazett||||0.213
91684412|NCT00261443|183259298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)||||0.708
91684413|NCT00261443|183259298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3||||0.107
91684414|NCT00261443|183259299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc (0.33)||||0.205
91684415|NCT00261443|183259299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.669||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)||||0.669
91684416|NCT00261443|183259299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3||||0.072
91684417|NCT00261443|183259300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline PR||||0.012
91684418|NCT00261443|183259300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)||||0.027
91684419|NCT00261443|183259300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in PR, Phase 3||||0.128
91684420|NCT00261443|183259301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.571||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline RR||||0.571
91684421|NCT00261443|183259301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)||||0.353
91684422|NCT00261443|183259301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Sample||||0.204
91719111|NCT03183908|183331120|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.4196|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes from Day 1 to Day 3 Group Comparisons||||0.4196
91526937|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|370.2||||0.0192|TWO_SIDED|95.0|62.6|677.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH effect||677.8|62.6|0.0192
91684423|NCT00261443|183259301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Sample||||0.435
91684424|NCT00261443|183259302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QRS||||0.826
91684425|NCT00261443|183259302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)||||0.545
91684426|NCT00261443|183259302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QRS, Phase 3||||0.372
91684427|NCT00261443|183259303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.235|TWO_SIDED|95.0|-0.07|0.27||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.27|-0.07|0.235
91684428|NCT00261443|183259303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36||||0.012|TWO_SIDED|95.0|0.08|0.64||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value in Change Treatment Difference||0.64|0.08|0.012
91719112|NCT03183908|183331120|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.2418|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2418
91684429|NCT00261443|183259304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.587||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Heart Rate||||0.587
91684430|NCT00261443|183259304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)||||0.386
91684431|NCT00261443|183259304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.405||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Heart Rate, Phase 3||||0.405
91684432|NCT00261443|183259304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3||||0.253
91684433|NCT00261443|183259305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.514|TWO_SIDED|95.0|-0.12|0.23||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.23|-0.12|0.514
91684434|NCT00261443|183259305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.362|TWO_SIDED|95.0|-0.14|0.38||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.38|-0.14|0.362
91684435|NCT00261443|183259306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.904|TWO_SIDED|95.0|-0.04|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.04|0.904
91684436|NCT00261443|183259306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.222|TWO_SIDED|95.0|-0.03|0.11||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.11|-0.03|0.222
91684437|NCT00261443|183259307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.808|TWO_SIDED|95.0|-0.03|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.03|0.808
91684438|NCT00261443|183259307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.771||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||||0.771
91684439|NCT00261443|183259308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01||||0.576|TWO_SIDED|95.0|-0.05|0.03||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.03|-0.05|0.576
91684440|NCT00261443|183259308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.636|TWO_SIDED|95.0|-0.05|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value treatment Difference||0.08|-0.05|0.636
91684441|NCT00261443|183259309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774|TWO_SIDED|95.0|-0.06|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.08|-0.06|0.774
91684442|NCT00261443|183259309|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.04||||0.444|TWO_SIDED|95.0|-0.06|0.14||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change, Treatment Difference||0.14|-0.06|0.444
91719113|NCT03183908|183331120|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.0746|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.0746
91719114|NCT03183908|183331120|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5497|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.5497
91684443|NCT02755649|183259323|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|16.87|42.05||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||42.05|16.87|< 0.0001
91684444|NCT02755649|183259323|SUPERIORITY||difference in percentages|33.0|||<|0.0001|TWO_SIDED|95.0|20.41|45.57||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||45.57|20.41|< 0.0001
91684445|NCT02755649|183259324|SUPERIORITY||Least square (LS) mean difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-38.85|-24.3||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach to control Type-1 error rate at 0.05 across 2 dose regimens.CI w/p-value based on treatment difference(dupilumab vs placebo) of LS mean percent change using multiple imputation (MI) w/ANCOVA model w/baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-24.3|-38.85|< 0.0001
91684446|NCT02755649|183259324|SUPERIORITY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-40.42|-25.88||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue \& then imputed by MI.||-25.88|-40.42|< 0.0001
91684447|NCT02755649|183259325|SUPERIORITY||LS mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.07|-17.41||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-17.41|-35.07|< 0.0001
91684448|NCT02755649|183259325|SUPERIORITY||LS Mean Difference]|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.34|-19.68||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-19.68|-37.34|< 0.0001
91684449|NCT02755649|183259326|SUPERIORITY||LS Mean Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.56|-21.93||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-21.93|-35.56|< 0.0001
91684450|NCT02755649|183259326|SUPERIORITY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.7|-26.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-26.06|-39.7|< 0.0001
91684451|NCT02755649|183259327|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|13.89|38.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||38.39|13.89|< 0.0001
91684452|NCT02755649|183259327|SUPERIORITY||difference in percentages|31.5|||<|0.0001|TWO_SIDED|95.0|19.08|43.83||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||43.83|19.08|< 0.0001
91719115|NCT03183908|183331121|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6278|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.6278
91684453|NCT02755649|183259328|SUPERIORITY||LS Mean Difference|-17.95|||<|0.0001|TWO_SIDED|95.0|-22.706|-13.197||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value is based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-13.197|-22.706|< 0.0001
91684454|NCT02755649|183259328|SUPERIORITY||LS Mean Difference|-19.66|||<|0.0001|TWO_SIDED|95.0|-24.431|-14.895||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-14.895|-24.431|< 0.0001
91684455|NCT02755649|183259329|SUPERIORITY||Difference in Percentages|25.2|||<|0.0001|TWO_SIDED|95.0|13.99|36.41||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||36.41|13.99|< 0.0001
91684456|NCT02755649|183259329|SUPERIORITY||Difference in Percentages|26.3|||<|0.0001|TWO_SIDED|95.0|14.95|37.65||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||37.65|14.95|< 0.0001
91684457|NCT02755649|183259330|SUPERIORITY||LS Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.6|-3.04||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.04|-5.6|< 0.0001
91684458|NCT02755649|183259330|SUPERIORITY||LS Mean Difference|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.31|-3.74||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.74|-6.31|< 0.0001
91684459|NCT02755649|183259331|SUPERIORITY||LS Mean Difference|-7.1|||<|0.0001|TWO_SIDED|95.0|-8.78|-5.47||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.47|-8.78|< 0.0001
91684460|NCT02755649|183259331|SUPERIORITY||LS Mean Difference|-7.6|||<|0.0001|TWO_SIDED|95.0|-9.29|-5.97||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.97|-9.29|< 0.0001
91684461|NCT02755649|183259332|SUPERIORITY||Difference in Percentages|30.1|||=|0.0002|TWO_SIDED|95.0|14.63|45.64||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||45.64|14.63|= 0.0002
91684462|NCT02755649|183259332|SUPERIORITY||Difference in Percentages|31.6|||=|0.0001|TWO_SIDED|95.0|16.11|47.05||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||47.05|16.11|= 0.0001
91684463|NCT02755649|183259333|SUPERIORITY||LS Mean Difference|-7.6|||=|0.0003|TWO_SIDED|95.0|-11.64|-3.51||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.51|-11.64|= 0.0003
91684464|NCT02755649|183259333|SUPERIORITY||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.15|-5.95||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.95|-14.15|< 0.0001
91684465|NCT02755649|183259334|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0001|TWO_SIDED|95.0|-4.41|-1.43||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.43|-4.41|= 0.0001
91684466|NCT02755649|183259334|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.38|-2.4||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-2.4|-5.38|< 0.0001
91684467|NCT02755649|183259335|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|17.1|41.96||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||41.96|17.1|< 0.0001
91684468|NCT02755649|183259335|SUPERIORITY||Difference in Percentages|40.4|||<|0.0001|TWO_SIDED|95.0|28.24|52.61||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||52.61|28.24|< 0.0001
91684469|NCT02755649|183259336|SUPERIORITY||LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-31.63|-16.88||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab group vs. placebo)of LS mean percent change using MI with ANCOVA with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\])as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-16.88|-31.63|< 0.0001
91684470|NCT02755649|183259336|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-33.49|-18.86||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata (disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-18.86|-33.49|< 0.0001
91684471|NCT02755649|183259337|SUPERIORITY||LS Mean Difference|-9.7|||=|0.0017|TWO_SIDED|95.0|-15.8|-3.66||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens. CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.66|-15.8|= 0.0017
91684472|NCT02755649|183259337|SUPERIORITY||LS Mean Difference|-7.2|||=|0.0214|TWO_SIDED|95.0|-13.31|-1.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.06|-13.31|= 0.0214
91684473|NCT02755649|183259338|SUPERIORITY||Difference in Percentages|-4.7|||=|0.1486|TWO_SIDED|95.0|-10.97|1.58|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||1.58|-10.97|= 0.1486
91684474|NCT02755649|183259338|SUPERIORITY||Difference in Percentages|-6.5|||=|0.0319|TWO_SIDED|95.0|-12.27|-0.65|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||-0.65|-12.27|= 0.0319
91719116|NCT03183908|183331121|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5622|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5622
91684475|NCT02755649|183259339|SUPERIORITY||difference in percentages|0.0|||=|0.9829|TWO_SIDED|95.0|-3.6|3.53|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.53|-3.6|= 0.9829
91684476|NCT02755649|183259339|SUPERIORITY||difference in percentages|0.0|||=|1|TWO_SIDED|95.0|-3.6|3.63|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.63|-3.6|= 1
91684477|NCT02755649|183259340|SUPERIORITY||difference in percentages|0.9|||=|0.5619|TWO_SIDED|95.0|-2.19|3.97|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.97|-2.19|= 0.5619
91684478|NCT02755649|183259340|SUPERIORITY||difference in percentages|-0.9|||=|0.3241|TWO_SIDED|95.0|-2.73|0.88|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||0.88|-2.73|= 0.3241
91684479|NCT02755649|183259341|SUPERIORITY||difference in percentages|-0.4|||=|0.9518|TWO_SIDED|95.0|-12.6|11.9|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||11.9|-12.6|= 0.9518
91684480|NCT02755649|183259341|SUPERIORITY||difference in percentages|2.5|||=|0.6833|TWO_SIDED|95.0|-9.64|14.68|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||14.68|-9.64|= 0.6833
91684481|NCT02089659|183259350|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.72|1.35|||||Moderate hepatic insufficiency / Healthy controls|||1.35|0.72|
91684482|NCT02089659|183259351|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.66|1.24|||||Moderate hepatic insufficiency / Healthy controls|||1.24|0.66|
91684483|NCT02089659|183259352|OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|90.0|0.74|1.18|||||Moderate hepatic insufficiency / Healthy controls|||1.18|0.74|
91684484|NCT02089659|183259353|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.74|1.33|||||Moderate hepatic insufficiency / Healthy controls|||1.33|0.74|
91526938|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|174.9||||0.2865|TWO_SIDED|95.0|-150.6|500.5|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH effect||500.5|-150.6|0.2865
91684485|NCT02126826|183259355|SUPERIORITY_OR_OTHER||Slope|0.7865|||||TWO_SIDED|90.0|0.6193|0.9537|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9537|0.6193|
91684486|NCT02126826|183259355|SUPERIORITY_OR_OTHER||Slope|1.0171|||||TWO_SIDED|90.0|0.8378|1.1964|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.1964|0.8378|
91684487|NCT02126826|183259357|SUPERIORITY_OR_OTHER||Slope|0.9511|||||TWO_SIDED|90.0|0.7654|1.1367|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1367|0.7654|
91684488|NCT02126826|183259357|SUPERIORITY_OR_OTHER||Slope|1.0834|||||TWO_SIDED|90.0|0.8655|1.3013|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3013|0.8655|
91684489|NCT02126826|183259359|SUPERIORITY_OR_OTHER||Slope|0.7832|||||TWO_SIDED|90.0|0.6235|0.9428|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9428|0.6235|
91684490|NCT02126826|183259359|SUPERIORITY_OR_OTHER||Slope|1.0365|||||TWO_SIDED|90.0|0.8593|1.2137|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.2137|0.8593|
91684491|NCT02126826|183259361|SUPERIORITY_OR_OTHER||Slope|0.9433|||||TWO_SIDED|90.0|0.7744|1.1122|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1122|0.7744|
91684492|NCT02126826|183259361|SUPERIORITY_OR_OTHER||Slope|1.081|||||TWO_SIDED|90.0|0.8583|1.3037|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3037|0.8583|
91684493|NCT01371747|183259362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91719117|NCT03183908|183331121|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5538|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.5538
91526939|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.6||||0.4279|TWO_SIDED|95.0|-307.5|132.2|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH morning||132.2|-307.5|0.4279
91526940|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.4||||0.6464|TWO_SIDED|95.0|-151.8|242.7|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH morning||242.7|-151.8|0.6464
91684494|NCT01371747|183259362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684495|NCT01371747|183259362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684496|NCT01371747|183259362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684497|NCT01371747|183259362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684498|NCT01371747|183259362|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684499|NCT01371747|183259363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684500|NCT01371747|183259363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684501|NCT01371747|183259363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684502|NCT01371747|183259363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684503|NCT01371747|183259363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684504|NCT01371747|183259363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684505|NCT01371747|183259364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684506|NCT01371747|183259364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684507|NCT01371747|183259364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684508|NCT01371747|183259364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684509|NCT01371747|183259364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684510|NCT01371747|183259364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
91684511|NCT01371747|183259365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.54|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684512|NCT01371747|183259365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684513|NCT01371747|183259365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684514|NCT01371747|183259365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.0|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684515|NCT01371747|183259365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.96|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684516|NCT01371747|183259365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684517|NCT01371747|183259366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684518|NCT01371747|183259366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.22|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684519|NCT01371747|183259366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684520|NCT01371747|183259366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.41|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684521|NCT01371747|183259366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684522|NCT01371747|183259366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.58|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
91684523|NCT01371747|183259367|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.3|100.0|||||2-sided 95% exact binomial CI|||100.0|94.3|
91684524|NCT01371747|183259367|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.5|100.0|||||2-sided 95% exact binomial CI|||100|94.5|
91684525|NCT01371747|183259367|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|98.4|||||TWO_SIDED|95.0|91.6|100.0|||||2-sided 95% exact binomial CI|||100|91.6|
91684526|NCT01371747|183259367|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
91684527|NCT01371747|183259367|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.8|||||TWO_SIDED|95.0|78.9|99.9|||||2-sided 95% exact binomial CI|||99.9|78.9|
91684528|NCT01371747|183259367|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.5|||||TWO_SIDED|95.0|77.2|99.9|||||2-sided 95% exact binomial CI|||99.9|77.2|
91684529|NCT01371747|183259368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.2|||||TWO_SIDED|95.0|86.7|99.0|||||2-sided 95% exact binomial CI|||99.0|86.7|
91684530|NCT01371747|183259368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.8|||||TWO_SIDED|95.0|81.0|96.5|||||2-sided 95% exact binomial CI|||96.5|81.0|
91526941|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-273.3||||0.0061|TWO_SIDED|95.0|-465.4|-81.2|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH morning||-81.2|-465.4|0.0061
91526942|NCT01036022|182929423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-115.2||||0.2614|TWO_SIDED|95.0|-318.5|88.1|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH morning||88.1|-318.5|0.2614
91684531|NCT01371747|183259368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.3|||||TWO_SIDED|95.0|69.5|89.9|||||2-sided 95% exact binomial CI|||89.9|69.5|
91684532|NCT01371747|183259368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|79.2|||||TWO_SIDED|95.0|57.8|92.9|||||2-sided 95% exact binomial CI|||92.9|57.8|
91684533|NCT01371747|183259368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
91684534|NCT01371747|183259368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|77.3|||||TWO_SIDED|95.0|54.6|92.2|||||2-sided 95% exact binomial CI|||92.2|54.6|
91684535|NCT01371747|183259370|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.3|||||TWO_SIDED|95.0|73.7|94.3|||||2-sided 95% exact binomial CI|||94.3|73.7|
91684536|NCT01371747|183259370|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.6|||||TWO_SIDED|95.0|68.0|91.2|||||2-sided 95% exact binomial CI|||91.2|68.0|
91684537|NCT01371747|183259370|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|88.9|||||TWO_SIDED|95.0|75.9|96.3|||||2-sided 95% exact binomial CI|||96.3|75.9|
91684538|NCT01371747|183259370|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.7|||||TWO_SIDED|95.0|59.5|98.3|||||2-sided 95% exact binomial CI|||98.3|59.5|
91684539|NCT01371747|183259370|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|89.5|||||TWO_SIDED|95.0|66.9|98.7|||||2-sided 95% exact binomial CI|||98.7|66.9|
91684540|NCT01371747|183259370|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|93.3|||||TWO_SIDED|95.0|68.1|99.8|||||2-sided 95% exact binomial CI|||99.8|68.1|
91684541|NCT03092219|183259371|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher Exact|For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.||||||0.0001
91684542|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.001||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrilysin (P09237) was analyzed.||||= 0.001
91684543|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.002||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of von Willebrand factor (P04275) was analyzed.||||= 0.002
91684544|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 4 (O95388) was analyzed.||||= 0.044
91684545|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta-1 proprotein (P01137) was analyzed.||||= 0.044
91684546|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.127||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta receptor type 3 (Q03167) was analyzed.||||= 0.127
91684547|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.21||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of IL-15 receptor subunit alpha (Q13261) was analyzed.||||= 0.210
91684548|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Metalloproteinase inhibitor 1 (P01033) was analyzed.||||= 0.215
91684549|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Pappalysin-1 (Q13219) was analyzed.||||= 0.215
91684550|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.745||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Proto-oncogene c-Src (P12931) was analyzed.||||= 0.745
91684551|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Protein AMBP (P02760) was analyzed.||||= 0.762
91684552|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Uromodulin (P07911) was analyzed.||||= 0.762
91684553|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Aminopeptidase N (P15144) was analyzed.||||= 0.762
91684554|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TNFRSF1A (P19438) was analyzed.||||= 0.762
91684555|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Plasminogen activator inhibitor 1 (P05121) was analyzed.||||= 0.917
91684556|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 2 (P29279) was analyzed.||||= 0.917
91684557|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of uPAR (Q03405) was analyzed.||||= 0.917
91684558|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 14 (Q16627) was analyzed.||||= 0.917
91684559|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 16 (O15467) was analyzed.||||= 0.979
91719118|NCT03183908|183331121|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.231|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2310
91684560|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Collagen alpha-1(I) chain (P02452) was analyzed.||||= 0.979
91684561|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Decorin (P07585) was analyzed.||||= 0.979
91684562|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 2 (P13500) was analyzed.||||= 0.979
91684563|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrix metalloproteinase-9 (P14780) was analyzed.||||= 0.979
91684564|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of E-selectin (P16581) was analyzed.||||= 0.979
91684565|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Thrombospondin-2 (P35442) was analyzed.||||= 0.979
91684566|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of RARRES2 (Q99969) was analyzed.||||= 0.979
91684567|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-X-C motif chemokine 16 (Q9H2A7) was analyzed.||||= 0.979
91684568|NCT05013008|183259422|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Dickkopf-related protein 3 (Q9UBP4) was analyzed.||||= 0.979
91684569|NCT00591773|183259453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.86|||<|0.001|TWO_SIDED|95.0|-18.54|-13.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-13.19|-18.54|<0.001
91684570|NCT00591773|183259453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-18.13|-12.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-12.76|-18.13|<0.001
91684571|NCT00591773|183259454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|||<|0.001|TWO_SIDED|95.0|-17.81|-10.99||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-10.99|-17.81|<0.001
91684572|NCT00591773|183259454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-16.1|-9.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.25|-16.10|<0.001
91684573|NCT00591773|183259455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.29|||<|0.001|TWO_SIDED|95.0|-12.02|-8.56||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.56|-12.02|<0.001
91684574|NCT00591773|183259455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|||<|0.001|TWO_SIDED|95.0|-12.23|-8.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.76|-12.23|<0.001
91684575|NCT00591773|183259456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.25|-5.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.25|-9.25|<0.001
91684576|NCT00591773|183259456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-9.06|-5.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.05|-9.06|<0.001
91684577|NCT00591773|183259457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-19.56|-14.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.04|-19.56|<0.001
91684578|NCT00591773|183259457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.24|||<|0.001|TWO_SIDED|95.0|-19.01|-13.47||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.47|-19.01|<0.001
91526943|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7559|TWO_SIDED|95.0|-2.0|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 1 SCCAI score||1.5|-2.0|0.7559
91684579|NCT00591773|183259458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-12.86|-9.18||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.18|-12.86|<0.001
91684580|NCT00591773|183259458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.04|-9.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.35|-13.04|<0.001
91684581|NCT00591773|183259459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.93|||<|0.001|TWO_SIDED|95.0|-15.92|-9.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.94|-15.92|<0.001
91684582|NCT00591773|183259459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.83|-9.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.84|-15.83|<0.001
91684583|NCT00591773|183259460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-10.14|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.14|<0.001
91684584|NCT00591773|183259460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|||<|0.001|TWO_SIDED|95.0|-10.15|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.15|<0.001
91684585|NCT00591773|183259461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-20.39|-14.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.64|-20.39|<0.001
91684586|NCT00591773|183259461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-19.84|-14.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.05|-19.84|<0.001
91684587|NCT00591773|183259462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54|||<|0.001|TWO_SIDED|95.0|-13.49|-9.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.59|-13.49|<0.001
91684588|NCT00591773|183259462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.68|||<|0.001|TWO_SIDED|95.0|-13.64|-9.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.72|-13.64|<0.001
91684589|NCT00591773|183259463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.04|||<|0.001|TWO_SIDED|95.0|-17.13|-10.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.94|-17.13|<0.001
91684590|NCT00591773|183259463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.48|||<|0.001|TWO_SIDED|95.0|-16.58|-10.37||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.37|-16.58|<0.001
91684591|NCT00591773|183259464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.42|||<|0.001|TWO_SIDED|95.0|-11.65|-7.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-11.65|<0.001
91684592|NCT00591773|183259464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69|||<|0.001|TWO_SIDED|95.0|-11.92|-7.46||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.46|-11.92|<0.001
91684593|NCT00591773|183259465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.38|7.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.03|2.38|<0.001
91684594|NCT00591773|183259465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.82|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|1.82|<0.001
91684595|NCT00591773|183259466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|1.9|7.27||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.27|1.90|<0.001
91684596|NCT00591773|183259466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.002|TWO_SIDED|95.0|1.46|5.0||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.00|1.46|0.002
91684597|NCT00591773|183259467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.41|6.64||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.64|2.41|<0.001
91684598|NCT00591773|183259467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.79||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.79|1.83|<0.001
91684599|NCT03022084|183259468|NON_INFERIORITY|The probability that Desyncra is non-inferior to CBT, defined by the sponsor as the event that mean TQ score change from baseline in the Desyncra arm is no more than 3.5 points worse than the mean TQ change in the CBT arm.|||||||||||||Bayesian|Data collected to date were analyzed using a Bayesian approach.|||Data collected to date were analyzed using a Bayesian approach.|||
91719119|NCT03183908|183331121|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.0435|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes from Day 1 to Day 3 Group Comparisons||||0.0435
91719120|NCT03183908|183331121|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6519|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes from Day 1 to Day 3 Group Comparisons||||0.6519
91719121|NCT03183908|183331122|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes from Day 1 to Day 3 Group Comparisons||||0.7483
91719122|NCT03183908|183331122|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.7483
91719123|NCT03183908|183331122|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4953|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.4953
91719124|NCT03183908|183331122|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8669|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes for Day 1 to Day 3 Group Comparisons||||0.8669
91719125|NCT03183908|183331122|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8451|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.8451
91719126|NCT03183908|183331122|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7376|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.7376
91719127|NCT03183908|183331123|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7407|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.7407
91719128|NCT03183908|183331124|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4032|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.4032
91719129|NCT03183908|183331125|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4079|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes from Day 1 to Day 3 Group Comparisons||||0.4079
91719130|NCT03183908|183331126|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7948|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes for Day 1 to Day 3 Group Comparisons||||0.7948
91719131|NCT03183908|183331127|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. Alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7953|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.7953
91719132|NCT03183908|183331128|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.9329|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.9329
91719133|NCT01588509|183331148|SUPERIORITY||Percent Change from Baseline|2.13||||0.002|TWO_SIDED|90.0|1.05|3.2|||ANOVA|||||3.20|1.05|0.002
91719134|NCT01588509|183331148|SUPERIORITY||Percent Change from Baseline|2.08||||0.002|TWO_SIDED|90.0|1.02|3.14|||ANOVA|||||3.14|1.02|0.002
91719135|NCT01588509|183331149|SUPERIORITY||Percent Change from Baseline|2.06|||<|0.001|TWO_SIDED|90.0|1.07|3.05|||ANOVA|||||3.05|1.07|<0.001
91719136|NCT01588509|183331149|SUPERIORITY||Percent Change from Baseline|1.92||||0.002|TWO_SIDED|90.0|0.95|2.89|||ANOVA|||||2.89|0.95|0.002
91719137|NCT01588509|183331150|SUPERIORITY||Percent Change from Baseline|1.38|||<|0.001|TWO_SIDED|90.0|0.81|1.95|||ANOVA|||||1.95|0.81|<0.001
91719138|NCT01588509|183331150|SUPERIORITY||Percent Change from Baseline|1.4|||<|0.001|TWO_SIDED|90.0|0.84|1.96|||ANOVA|||||1.96|0.84|<0.001
91719139|NCT00393367|183331156|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||The difference in median improvement between treatment groups was expected to be greater than 2.|Wilcoxon (Mann-Whitney)|||||||0.44
91719140|NCT00393367|183331157|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.97|TWO_SIDED|95.0|-0.14|0.14|||Chi-squared|||||0.14|-0.14|0.97
91719141|NCT00393367|183331158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.0|6.0|||t-test, 2 sided|||||6|-7|
91719142|NCT00393367|183331159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-3.0|3.0|||t-test, 2 sided|||||3|-3|
91719143|NCT00393367|183331160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1|-1|
91719144|NCT00393367|183331161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03||||0.69||95.0|-0.2|0.14|||Chi-squared|||||0.14|-0.20|0.69
91719145|NCT00393367|183331162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.08|TWO_SIDED|95.0|-0.02|0.47|||Chi-squared|||||0.47|-0.02|0.08
91719146|NCT00393367|183331163|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.22|TWO_SIDED|95.0|-0.37|0.08|||Chi-squared|||||0.08|-0.37|0.22
91719147|NCT00393367|183331165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.78|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||||0.8|-0.6|0.78
91719148|NCT01944423|183331168|SUPERIORITY||Logit difference (final values)|0.64|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.25|0.97||p=ns 2-sided|two-phase growth curve model|||||0.97|-2.25|
91719149|NCT01944423|183331169|SUPERIORITY||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|1.87||0.038|TWO_SIDED|95.0|0.25|7.94||2-sided|two-phase growth curve model|||At end-of-treatment||7.94|0.25|.038
91526944|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.1238|TWO_SIDED|95.0|-0.4|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 1 SCCAI score||3.2|-0.4|0.1238
91684600|NCT00605540|183259469|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.||||0.09
91684601|NCT01235195|183259478|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|104.86|||||TWO_SIDED|90.0|100.12|109.83|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||109.83|100.12|
91684602|NCT01235195|183259479|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|105.34|||||TWO_SIDED|90.0|98.46|112.69|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.69|98.46|
91684603|NCT01235195|183259481|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|106.1|||||TWO_SIDED|90.0|100.16|112.39|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.39|100.16|
91684604|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16||0.459|TWO_SIDED|90.0|-1.05|-0.52|||Bayesian|||||-0.52|-1.05|0.459
91684605|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.16||0.511|TWO_SIDED|90.0|-1.07|-0.54|||Bayesian|||||-0.54|-1.07|0.511
91684606|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.16||0.988|TWO_SIDED|90.0|-1.41|-0.89|||Bayesian|||||-0.89|-1.41|0.988
91684607|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.16||0.934|TWO_SIDED|90.0|-1.3|-0.78|||Bayesian|||||-0.78|-1.30|0.934
91684608|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.16||0.373|TWO_SIDED|90.0|0.08|0.61|||Bayesian|||||0.61|0.08|0.373
91684609|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.433|TWO_SIDED|90.0|0.07|0.59|||Bayesian|||||0.59|0.07|0.433
91684610|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.978|TWO_SIDED|90.0|-0.28|0.24|||Bayesian|||||0.24|-0.28|0.978
91684611|NCT02119819|183259484|SUPERIORITY||Posterior Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.904|TWO_SIDED|90.0|-0.17|0.35|||Bayesian|||||0.35|-0.17|0.904
91684612|NCT05384171|183259511|SUPERIORITY||Partial Eta Squared (effect size)|0.02||||0.617|TWO_SIDED||||||ANCOVA|||||||.617
91684613|NCT05384171|183259513|SUPERIORITY||Partial Eta Squared (effect size)|0.089||||0.214|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group intention follow-up means are equal when controlling for covariates (i.e., baseline intention scores and age)||||.214
91684614|NCT05384171|183259513|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.894|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group attitude follow-up means are equal when controlling for covariates (i.e., baseline attitude scores and age)||||.894
91719150|NCT01944423|183331170|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.15|5.26||2-sided|two-phase growth curve model|||At 6 month follow-up||5.26|1.15|.003
91719151|NCT00204737|183331186|OTHER|||||||0.06|||||||Fisher Exact|||comparison at 2 Weeks||||0.06
91719152|NCT00204737|183331186|OTHER|||||||0.18|||||||Fisher Exact|||Comparison at 6 Weeks||||0.18
91684615|NCT05384171|183259513|SUPERIORITY||Partial Eta Squared (Effect Size)|0.053||||0.359|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group social norms follow-up means are equal when controlling for covariates (i.e., baseline social norms scores and age)||||.359
91684616|NCT05384171|183259513|SUPERIORITY||Partial Eta Squared (Effect Size)|0.058||||0.322|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group perceived behavioral control follow-up means are equal when controlling for covariates (i.e., baseline perceived behavioral control scores and age)||||.322
91684617|NCT05384171|183259514|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.891|TWO_SIDED||||||ANCOVA|||||||.891
91684618|NCT02052011|183259572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.08|0.62||||||||0.62|-0.08|
91684619|NCT01851330|183259573|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91684620|NCT01851330|183259573|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91684621|NCT01851330|183259573|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91719153|NCT00204737|183331186|OTHER|||||||0.5|||||||Fisher Exact|||Comparison at 12 weeks||||0.5
91719154|NCT00486044|183331219|SUPERIORITY_OR_OTHER|||||||0.966||95.0|||||Kruskal-Wallis|||||||0.966
91719155|NCT00486044|183331220|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
91719156|NCT00486044|183331221|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Kruskal-Wallis|||||||0.113
91487364|NCT02642029|182847279|OTHER|Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|beta coefficient for depressed mood|0.00071||||0.243|TWO_SIDED|95.0|-0.00048|0.0019|||Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, depressed mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00190|-0.00048|0.243
91487365|NCT02642029|182847280|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.83||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.830
91719157|NCT00486044|183331222|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal-Wallis|||||||0.210
91719158|NCT02701634|183331223|SUPERIORITY|||||||0.99||||||P-value was calculated using the stratified Cochran-Mantel-Haenszel Chi-square test.|Chi-squared|||||||0.99
91487366|NCT02642029|182847280|OTHER||beta coefficient for anxiety|-0.00063||||0.284|TWO_SIDED|95.0|-0.00179|0.00052||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, anxiety). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00052|-0.00179|0.284
91719159|NCT02701634|183331228|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
91719160|NCT02701634|183331229|SUPERIORITY|||||||0.33||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.33
91719161|NCT02701634|183331230|SUPERIORITY|||||||0.49||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.49
91719162|NCT02701634|183331231|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.55|2.18||P-value was calculated using the log-rank test and stratified for disease severity and usage of calcineurin inhibitor or mycophenolate mofetil (MMF).|Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for disease severity and usage of calcineurin inhibitor or MMF|||2.18|0.55|0.800
91719163|NCT01206764|183331235|OTHER|Kaplan Meier|Median Difference (Net)|27.71|||||TWO_SIDED|95.0|21.86|35.29||||||Single arm open label study||35.29|21.86|
91719164|NCT01206764|183331239|OTHER|Kaplan Meier|Median Difference (Net)|45.71|||||TWO_SIDED|95.0|31.29|106.43||||||The median overall survival was not evaluable, this presents the 25th percentile of overall survival||106.43|31.29|
91719165|NCT00997893|183331243|OTHER|||||||0.004||||||treatment x time p=.004|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo. Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.004
91719166|NCT00997893|183331244|OTHER|||||||0.98||||||visit x time x treatment interaction p=.98|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo before and after a psychosocial stressor. Predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.98
91684622|NCT01851330|183259573|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.|Difference in proportions|-3.2|||||TWO_SIDED|97.5|-8.3|1.8|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||1.8|-8.3|
91684623|NCT01851330|183259573|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|-2.3|||||TWO_SIDED|97.5|-7.2|2.5|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||2.5|-7.2|
91684624|NCT01851330|183259573|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||5.7|-3.9|
91684625|NCT01590797|183259586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.5|-0.19|||Robust Regression|Robust regression using M-estimation with terms for treatment and the metformin stratum and type of insulin, and baseline A1C (%) as a covariate.||||-0.19|-0.50|<0.001
91487367|NCT02642029|182847281|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.755||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.755
91684626|NCT01590797|183259587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Robust Regression|Robust regression using M-estimation with terms for treatment and type of insulin, and baseline A1C (%) as a covariate.||||-0.14|-0.61|0.002
91684627|NCT01590797|183259588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|||<|0.001|TWO_SIDED|95.0|-38.4|-14.7|||ANCOVA|ANCOVA model with terms for treatment and the metformin stratum and type of insulin, and baseline 2-hr Post- Meal Glucose (mg/dL) as a covariate.||||-14.7|-38.4|<0.001
91684628|NCT03106987|183259591|OTHER||Hazard Ratio (HR)|0.566||||0.022|TWO_SIDED|95.0|0.372|0.868|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.868|0.372|0.0220
91684629|NCT03106987|183259591|OTHER||Hazard Ratio (HR)|0.43||||0.0023|TWO_SIDED|95.0|0.264|0.708|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.708|0.264|0.0023
91684630|NCT02114385|183259615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.04|1.45|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 6||1.45|1.04|<0.001
91684631|NCT02114385|183259615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 11||1.04|0.76|<0.001
91684632|NCT02114385|183259615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.21|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.21|0.89|<0.001
91684633|NCT02114385|183259615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.91|1.37|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.37|0.91|<0.001
91684634|NCT01651793|183259655|SUPERIORITY|||||||0.05||||||P value reference to the beverage x time interaction effect|ANCOVA|||Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night's sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.||||0.05
91684635|NCT01120704|183259665|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.906||||0.045|TWO_SIDED|95.0|0.822|0.998|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||.998|.822|.045
91684636|NCT01120704|183259665|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.982||||0.705|TWO_SIDED|95.0|0.892|1.081|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.081|.892|.705
91684637|NCT01120704|183259665|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.044||||0.382|TWO_SIDED|95.0|0.948|1.149|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.149|.948|.382
91684638|NCT01120704|183259665|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.339|TWO_SIDED|95.0|0.867|1.05|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.050|.867|.339
91684639|NCT01120704|183259665|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.945||||0.248|TWO_SIDED|95.0|0.858|1.04|||Regression, Cox|||||1.040|.858|.248
91684640|NCT01120704|183259666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.402||||0.011|TWO_SIDED|95.0|1.08|1.821|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.||1.821|1.080|.011
91684641|NCT01120704|183259666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.956|TWO_SIDED|95.0|0.769|1.321|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.321|.769|.956
91684642|NCT01120704|183259666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.885|TWO_SIDED|95.0|0.797|1.301|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.301|.797|.885
91684643|NCT01120704|183259666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.852||||0.205|TWO_SIDED|95.0|0.664|1.092|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.||1.092|.664|.205
91684644|NCT01120704|183259666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.514|TWO_SIDED|95.0|0.842|1.411|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.||1.411|.842|.514
91684645|NCT01292226|183259710|SUPERIORITY_OR_OTHER|||||||0.4505||||||Free MPA, time 0 \[trough\]|ANOVA|Analysis of variance (ANOVA)||||||0.4505
91684646|NCT01292226|183259710|SUPERIORITY_OR_OTHER|||||||0.7322||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7322
91684647|NCT01292226|183259710|SUPERIORITY_OR_OTHER|||||||0.6798||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6798
91684648|NCT01292226|183259710|SUPERIORITY_OR_OTHER|||||||0.541||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.5410
91684649|NCT01292226|183259711|SUPERIORITY_OR_OTHER|||||||0.3892||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.3892
91684650|NCT01292226|183259711|SUPERIORITY_OR_OTHER|||||||0.6564||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6564
91684651|NCT01292226|183259711|SUPERIORITY_OR_OTHER|||||||0.7772||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7772
91684652|NCT01292226|183259711|SUPERIORITY_OR_OTHER|||||||0.0958||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.0958
91684653|NCT01292226|183259712|SUPERIORITY_OR_OTHER|||||||0.5796||||||Time 0 \[trough\]|ANOVA|||||||0.5796
91684654|NCT01292226|183259712|SUPERIORITY_OR_OTHER|||||||0.3428||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3428
91684655|NCT01292226|183259713|SUPERIORITY_OR_OTHER|||||||0.9372||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.9372
91684656|NCT01292226|183259713|SUPERIORITY_OR_OTHER|||||||0.9904||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.9904
91684657|NCT01292226|183259713|SUPERIORITY_OR_OTHER|||||||0.3658||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3658
91684658|NCT01292226|183259713|SUPERIORITY_OR_OTHER|||||||0.2987||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.2987
91684659|NCT01292226|183259714|SUPERIORITY_OR_OTHER|||||||0.7455||||||time 0 \[trough\]|ANOVA|||||||0.7455
91684660|NCT01292226|183259714|SUPERIORITY_OR_OTHER|||||||0.8504||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.8504
91684661|NCT01292226|183259715|SUPERIORITY_OR_OTHER|||||||0.6847||||||IMPDH I, time 0 \[trough\]|ANOVA|||||||0.6847
91684662|NCT01292226|183259715|SUPERIORITY_OR_OTHER|||||||0.3184||||||IMPDH I, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3184
91684663|NCT01292226|183259715|SUPERIORITY_OR_OTHER|||||||0.3862||||||IMPDH II, time 0 \[trough\]|ANOVA|||||||0.3862
91684664|NCT01292226|183259715|SUPERIORITY_OR_OTHER|||||||0.904||||||IMPDH II, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9040
91684665|NCT01292226|183259715|SUPERIORITY_OR_OTHER|||||||0.0907||||||IMPDH activity, time 0 \[trough\]|ANOVA|||||||0.0907
91684666|NCT01292226|183259715|SUPERIORITY_OR_OTHER|||||||0.963||||||IMPDH activity, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9630
91684667|NCT01292226|183259716|SUPERIORITY_OR_OTHER|||||||0.413||||||IMPDH I|ANOVA|||||||0.4130
91684668|NCT01292226|183259716|SUPERIORITY_OR_OTHER|||||||0.3823||||||IMPDH II|ANOVA|||||||0.3823
91684669|NCT01292226|183259717|SUPERIORITY_OR_OTHER|||||||0.0316||||||IMPDH I|ANOVA|||||||0.0316
91684670|NCT01292226|183259717|SUPERIORITY_OR_OTHER|||||||0.944||||||IMPDH II|ANOVA|||||||0.9440
91684671|NCT01292226|183259718|SUPERIORITY_OR_OTHER|||||||0.1328||||||IMPDH I|ANOVA|||||||0.1328
91684672|NCT01292226|183259718|SUPERIORITY_OR_OTHER|||||||0.576||||||IMPDH II|ANOVA|||||||0.5760
91684673|NCT01292226|183259719|SUPERIORITY_OR_OTHER|||||||0.7332||||||Free MPA|ANOVA|||||||0.7332
91684674|NCT01292226|183259719|SUPERIORITY_OR_OTHER|||||||0.2681||||||Total MPA|ANOVA|||||||0.2681
91684675|NCT01292226|183259719|SUPERIORITY_OR_OTHER|||||||0.7087||||||AUC MPA|ANOVA|||||||0.7087
91684676|NCT01292226|183259720|SUPERIORITY_OR_OTHER|||||||0.9432||||||Free MPA|ANOVA|||||||0.9432
91684677|NCT01292226|183259720|SUPERIORITY_OR_OTHER|||||||0.5177||||||Total MPA|ANOVA|||||||0.5177
91684678|NCT01292226|183259720|SUPERIORITY_OR_OTHER|||||||0.6398||||||AUC MPA|ANOVA|||||||0.6398
91684679|NCT01292226|183259721|SUPERIORITY_OR_OTHER|||||||0.0656||||||Free MPA|ANOVA|||||||0.0656
91684680|NCT01292226|183259721|SUPERIORITY_OR_OTHER|||||||0.0131||||||Total MPA|ANOVA|||||||0.0131
91684681|NCT01292226|183259721|SUPERIORITY_OR_OTHER|||||||0.0515||||||AUC MPA|ANOVA|||||||0.0515
91684682|NCT03898908|183259737|SUPERIORITY|||||||0.015||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and Week 8||||0.015
91719167|NCT00997893|183331245|OTHER|||||||0.68||||||treatment x time (before and after the psychosocial stressor) x visit p=.68|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on emotional memory following a laboratory induced stress. Primary predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.68
91719168|NCT00997893|183331246|OTHER|||||||0.11||||||treatment x time p=.11|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate). Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.11
91719169|NCT00997893|183331247|OTHER|||||||0.86||||||treatment x time p=.86|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate)Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.86
91719170|NCT03620162|183331248|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.525|TWO_SIDED|95.0|-13.6|7.0|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 5 vs 1)||7.0|-13.6|= 0.525
91719171|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.5|||=|0.396|TWO_SIDED|95.0|-14.7|5.8|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 4 vs 1)||5.8|-14.7|= 0.396
91719172|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.097|TWO_SIDED|95.0|-18.8|1.6|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 3 vs 1)||1.6|-18.8|= 0.097
91719173|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.9|||=|0.057|TWO_SIDED|95.0|-19.9|0.3|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 2 vs 1)||0.3|-19.9|= 0.057
91526945|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6302|TWO_SIDED|95.0|-1.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 1 SCCAI score||2.2|-1.3|0.6302
91684683|NCT03898908|183259738|SUPERIORITY|||||||0.754||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and W24||||0.754
91684684|NCT00468650|183259740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.96|STANDARD_DEVIATION|5.19|<|0.001||95.0|10.0|11.93||"Statistical significance will be declared if the p-value is \<0.05.~Change from Baseline: Week 6 (LOCF) minus Baseline"|t-test, 2 sided|single sample t-test||Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.||11.93|10.00|<0.001
91684685|NCT00468650|183259741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.14|STANDARD_DEVIATION|5.21|<|0.001||95.0|6.17|8.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||8.11|6.17|<0.001
91684686|NCT00468650|183259741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.57|STANDARD_DEVIATION|5.43|<|0.001||95.0|9.56|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||11.59|9.56|<0.001
91684687|NCT00468650|183259741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.93|STANDARD_DEVIATION|5.26|<|0.001||95.0|9.93|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||11.92|9.93|<0.001
91684688|NCT00468650|183259741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.95|STANDARD_DEVIATION|5.21|<|0.001||95.0|9.97|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 endpoint minus baseline||11.92|9.97|<0.001
91719174|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.4|||=|0.085|TWO_SIDED|95.0|-17.8|1.2|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 5 vs 1)||1.2|-17.8|= 0.085
91719175|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.5|||=|0.05|TWO_SIDED|95.0|-18.9|0.0|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 4 vs 1)||-0.0|-18.9|= 0.050
91719176|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.5|||=|0.183|TWO_SIDED|95.0|-16.1|3.1|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 3 vs 1)||3.1|-16.1|= 0.183
91719177|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.074|TWO_SIDED|95.0|-18.1|0.8|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 2 vs 1)||0.8|-18.1|= 0.074
91684689|NCT00468650|183259742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.48|STANDARD_DEVIATION|3.97|<|0.001||95.0|2.74|4.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.23|2.74|<0.001
91684690|NCT00468650|183259742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.88|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.05|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.71|3.05|<0.001
91684691|NCT00468650|183259742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
91684692|NCT00468650|183259742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
91684693|NCT00468650|183259743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.89|STANDARD_DEVIATION|2.4|<|0.001||95.0|1.45|2.34||p-value not adjusted for multiple comparisons. Threshold for significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||2.34|1.45|<0.001
91684694|NCT00468650|183259743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.46|STANDARD_DEVIATION|2.32|<|0.001||95.0|2.02|2.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.89|2.02|<0.001
91684695|NCT00468650|183259743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.13|3.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||3.05|2.13|<0.001
91684696|NCT00468650|183259743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.63|STANDARD_DEVIATION|2.45|<|0.001||95.0|2.17|3.08||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||3.08|2.17|<0.001
91684697|NCT00468650|183259743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.14|3.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||3.04|2.14|<0.001
91684698|NCT00468650|183259744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.61|STANDARD_DEVIATION|1.51|<|0.001||95.0|0.32|0.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.89|0.32|<0.001
91684699|NCT00468650|183259744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|1.46|<|0.001||95.0|0.47|1.02||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.02|0.47|<0.001
91684700|NCT00468650|183259744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.01|0.47|<0.001
91719178|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.525|TWO_SIDED|95.0|-7.0|13.6|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 5 vs 1)||13.6|-7.0|= 0.525
91684701|NCT00468650|183259744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.01|0.47|<0.001
91684702|NCT00468650|183259745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.43|STANDARD_DEVIATION|1.87|<|0.001||95.0|1.09|1.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||1.78|1.09|<0.001
91684703|NCT00468650|183259745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.86|<|0.001||95.0|1.65|2.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.35|1.65|<0.001
91684704|NCT00468650|183259745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.89|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||2.62|1.89|<0.001
91684705|NCT00468650|183259745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.26|STANDARD_DEVIATION|1.94|<|0.001||95.0|1.9|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||2.62|1.90|<0.001
91684706|NCT00468650|183259745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|1.93|<|0.001||95.0|1.91|2.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||2.64|1.91|<0.001
91684707|NCT00468650|183259746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.55|STANDARD_DEVIATION|1.41|<|0.001||95.0|0.29|0.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.82|0.29|<0.001
91684708|NCT00468650|183259746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.81|STANDARD_DEVIATION|1.47|<|0.001||95.0|0.53|1.09||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.09|0.53|<0.001
91684709|NCT00468650|183259746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.11|0.55|<0.001
91684710|NCT00468650|183259746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.11|0.55|<0.001
91684711|NCT00468650|183259747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.18|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.73|3.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.63|2.73|<0.001
91684712|NCT00468650|183259747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.38|STANDARD_DEVIATION|2.39|<|0.001||95.0|3.94|4.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.83|3.94|<0.001
91684713|NCT00468650|183259747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.73|STANDARD_DEVIATION|2.53|<|0.001||95.0|4.25|5.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.21|4.25|<0.001
91684714|NCT00468650|183259747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.7|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.23|5.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.17|4.23|<0.001
91684715|NCT00468650|183259747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.72|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.25|5.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.19|4.25|<0.001
91684716|NCT00468650|183259748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.1|<|0.001||95.0|0.8|1.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.59|0.80|<0.001
91684717|NCT00468650|183259748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.2|<|0.001||95.0|1.12|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.95|1.12|<0.001
91684718|NCT00468650|183259748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.95|1.13|<0.001
91684719|NCT00468650|183259748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.95|1.13|<0.001
91684720|NCT00468650|183259749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.73|STANDARD_DEVIATION|2.38|<|0.001||95.0|2.28|3.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.17|2.28|<0.001
91684721|NCT00468650|183259749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.49|<|0.001||95.0|3.2|4.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.14|3.20|<0.001
91684722|NCT00468650|183259749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.92|STANDARD_DEVIATION|2.52|<|0.001||95.0|3.44|4.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||4.40|3.44|<0.001
91684723|NCT00468650|183259749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.44|4.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||4.38|3.44|<0.001
91684724|NCT00468650|183259749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.89|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.42|4.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||4.37|3.42|<0.001
91684725|NCT00468650|183259750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.97|STANDARD_DEVIATION|1.88|<|0.001||95.0|0.62|1.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.32|0.62|<0.001
91684726|NCT00468650|183259750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.21|STANDARD_DEVIATION|1.92|<|0.001||95.0|0.85|1.57||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.57|0.85|<0.001
91684727|NCT00468650|183259750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.55|0.84|<0.001
91684728|NCT00468650|183259750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.55|0.84|<0.001
91684729|NCT00468650|183259751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.71|STANDARD_DEVIATION|25.36|<|0.001||95.0|27.98|37.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||37.43|27.98|<0.001
91684730|NCT00468650|183259751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|46.21|STANDARD_DEVIATION|26.27|<|0.001||95.0|41.29|51.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||51.12|41.29|<0.001
91684731|NCT00468650|183259751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.53|STANDARD_DEVIATION|26.96|<|0.001||95.0|40.44|50.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||50.63|40.44|<0.001
91526946|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.2777|TWO_SIDED|95.0|-0.8|2.8|||Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 1 SCCAI score||2.8|-0.8|0.2777
91684732|NCT00468650|183259751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.28|STANDARD_DEVIATION|27.01|<|0.001||95.0|40.25|50.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||50.31|40.25|<0.001
91684733|NCT00468650|183259751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.05|STANDARD_DEVIATION|27.02|<|0.001||95.0|39.99|50.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||50.11|39.99|<0.001
91719179|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.915|TWO_SIDED|95.0|-10.8|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 4 vs 1)||9.7|-10.8|= 0.915
91684734|NCT00468650|183259752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.84|STANDARD_DEVIATION|21.1|<|0.001||95.0|9.89|17.79||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||17.79|9.89|<0.001
91684735|NCT00468650|183259752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.07|STANDARD_DEVIATION|24.25|<|0.001||95.0|8.49|17.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||17.65|8.49|<0.001
91684736|NCT00468650|183259752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||17.23|8.14|<0.001
91684737|NCT00468650|183259752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||17.23|8.14|<0.001
91684738|NCT00468650|183259753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.41|STANDARD_DEVIATION|4.4|<|0.001||95.0|4.59|6.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||6.23|4.59|<0.001
91684739|NCT00468650|183259753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.85|STANDARD_DEVIATION|4.96|<|0.001||95.0|7.92|9.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||9.78|7.92|<0.001
91684740|NCT00468650|183259753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.21|STANDARD_DEVIATION|5.19|<|0.001||95.0|8.23|10.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||10.19|8.23|<0.001
91684741|NCT00468650|183259753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.28|STANDARD_DEVIATION|5.14|<|0.001||95.0|8.32|10.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||10.24|8.32|<0.001
91684742|NCT00468650|183259753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.25|STANDARD_DEVIATION|5.15|<|0.001||95.0|8.28|10.22||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||10.22|8.28|<0.001
91684743|NCT00468650|183259754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.51|STANDARD_DEVIATION|3.89|<|0.001||95.0|2.78|4.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.24|2.78|<0.001
91684744|NCT00468650|183259754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.41|<|0.001||95.0|3.08|4.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||4.74|3.08|<0.001
91684745|NCT00468650|183259754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.73|3.09|<0.001
91684746|NCT00468650|183259754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.73|3.09|<0.001
91684747|NCT00468650|183259755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.68|STANDARD_DEVIATION|4.86|<|0.001||95.0|5.77|7.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||7.59|5.77|<0.001
91684748|NCT00468650|183259755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.94|STANDARD_DEVIATION|5.21|<|0.001||95.0|8.96|10.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||10.91|8.96|<0.001
91684749|NCT00468650|183259755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.59|STANDARD_DEVIATION|5.08|<|0.001||95.0|9.62|11.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||11.56|9.62|<0.001
91684750|NCT00468650|183259755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.63|STANDARD_DEVIATION|5.03|<|0.001||95.0|9.68|11.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||11.58|9.68|<0.001
91684751|NCT00468650|183259755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.64|STANDARD_DEVIATION|5.06|<|0.001||95.0|9.68|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||11.59|9.68|<0.001
91684752|NCT00468650|183259756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.29|STANDARD_DEVIATION|4.1|<|0.001||95.0|2.52|4.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.05|2.52|<0.001
91684753|NCT00468650|183259756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.03|STANDARD_DEVIATION|5.09|<|0.001||95.0|3.06|5.0||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.00|3.06|<0.001
91684754|NCT00468650|183259756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.96|3.06|<0.001
91684755|NCT00468650|183259756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.96|3.06|<0.001
91684756|NCT00468650|183259757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.33|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.24|2.33|<0.001
91684757|NCT00468650|183259757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.23|STANDARD_DEVIATION|2.56|<|0.001||95.0|3.74|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.71|3.74|<0.001
91684758|NCT00468650|183259757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.74|STANDARD_DEVIATION|2.84|<|0.001||95.0|4.2|5.28||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.28|4.20|<0.001
91684759|NCT00468650|183259757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.78|STANDARD_DEVIATION|2.81|<|0.001||95.0|4.25|5.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.31|4.25|<0.001
91684760|NCT00468650|183259757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.76|STANDARD_DEVIATION|2.82|<|0.001||95.0|4.23|5.3||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.30|4.23|<0.001
91684761|NCT00468650|183259758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.13|1.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.85|1.13|<0.001
91684762|NCT00468650|183259758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.96|STANDARD_DEVIATION|2.08|<|0.001||95.0|1.57|2.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.36|1.57|<0.001
91684763|NCT00468650|183259758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||2.37|1.59|<0.001
91684764|NCT00468650|183259758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||2.37|1.59|<0.001
91684765|NCT00468650|183259759|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|8.84|STANDARD_DEVIATION|28.7||0.0016||95.0|3.42|14.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||14.26|3.42|0.0016
91684766|NCT00468650|183259759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.18|STANDARD_DEVIATION|27.51|<|0.001||95.0|4.93|15.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||15.43|4.93|<0.001
91684767|NCT00468650|183259759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.29|STANDARD_DEVIATION|28.88|<|0.001||95.0|6.7|17.88||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||17.88|6.70|<0.001
91684768|NCT00468650|183259759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.96|STANDARD_DEVIATION|28.33|<|0.001||95.0|6.61|17.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||17.32|6.61|<0.001
91684769|NCT00468650|183259759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.95|STANDARD_DEVIATION|28.55|<|0.001||95.0|6.51|17.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||17.40|6.51|<0.001
91684770|NCT00468650|183259760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.37|STANDARD_DEVIATION|14.85||0.3324||95.0|-1.42|4.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.17|-1.42|0.3324
91684771|NCT00468650|183259760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.12|STANDARD_DEVIATION|14.26||0.0249||95.0|0.4|5.84||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.84|0.40|0.0249
91684772|NCT00468650|183259760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.98|STANDARD_DEVIATION|13.95||0.0249||95.0|0.37|5.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||5.58|0.37|0.0249
91684773|NCT00468650|183259760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.04|STANDARD_DEVIATION|14.07||0.0249||95.0|0.39|5.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||5.68|0.39|0.0249
91487368|NCT02642029|182847281|OTHER||beta coefficient for elated mood|-0.0007||||0.317|TWO_SIDED|95.0|-0.00208|0.00067||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, elated mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00067|-0.00208|0.317
91684774|NCT00468650|183259761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.37|STANDARD_DEVIATION|30.51|<|0.001||95.0|9.38|21.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||21.36|9.38|<0.001
91684775|NCT00468650|183259761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.15|STANDARD_DEVIATION|32.22|<|0.001||95.0|10.76|23.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||23.55|10.76|<0.001
91684776|NCT00468650|183259761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.22|STANDARD_DEVIATION|32.44|<|0.001||95.0|11.68|24.76||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||24.76|11.68|<0.001
91684777|NCT00468650|183259761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.33|STANDARD_DEVIATION|31.87|<|0.001||95.0|11.07|23.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||23.59|11.07|<0.001
91684778|NCT00468650|183259761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.68|STANDARD_DEVIATION|32.1|<|0.001||95.0|11.31|24.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||24.04|11.31|<0.001
91684779|NCT00468650|183259762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.46|STANDARD_DEVIATION|9.41||0.1061||95.0|-0.32|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||3.24|-0.32|0.1061
91684780|NCT00468650|183259762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.18|STANDARD_DEVIATION|12.33||0.3237||95.0|-1.18|3.54||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||3.54|-1.18|0.3237
91684781|NCT00468650|183259762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.13|STANDARD_DEVIATION|12.05||0.3236||95.0|-1.13|3.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||3.38|-1.13|0.3236
91684782|NCT00468650|183259762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.15|STANDARD_DEVIATION|12.16||0.3236||95.0|-1.15|3.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||3.45|-1.15|0.3236
91684783|NCT00468650|183259763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||64.60|49.31|<0.001
91684784|NCT00468650|183259763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
91684785|NCT00468650|183259763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
91684786|NCT00468650|183259763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
91684787|NCT00468650|183259763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
91684788|NCT00468650|183259764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
91684789|NCT00468650|183259764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
91684790|NCT00468650|183259764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
91684791|NCT00468650|183259764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
91684792|NCT00468650|183259765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.58|STANDARD_DEVIATION|41.24|<|0.001||95.0|50.48|66.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||66.68|50.48|<0.001
91684793|NCT00468650|183259765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|76.29|STANDARD_DEVIATION|37.21|<|0.001||95.0|68.9|83.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||83.67|68.90|<0.001
91684794|NCT00468650|183259765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|77.69|STANDARD_DEVIATION|37.26|<|0.001||95.0|70.18|85.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||85.21|70.18|<0.001
91526947|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8069|TWO_SIDED|95.0|-1.4|1.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 1 SCCAI score||1.8|-1.4|0.8069
91684795|NCT00468650|183259765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.79|STANDARD_DEVIATION|36.65|<|0.001||95.0|71.59|85.99||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||85.99|71.59|<0.001
91684796|NCT00468650|183259765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.36|STANDARD_DEVIATION|36.89|<|0.001||95.0|71.04|85.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||85.68|71.04|<0.001
91684797|NCT00468650|183259766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.9|STANDARD_DEVIATION|36.63|<|0.001||95.0|10.98|24.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||24.83|10.98|<0.001
91684798|NCT00468650|183259766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.5|STANDARD_DEVIATION|36.84|<|0.001||95.0|12.44|26.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||26.56|12.44|<0.001
91684799|NCT00468650|183259766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.52|STANDARD_DEVIATION|36.99|<|0.001||95.0|12.59|26.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||26.45|12.59|<0.001
91684800|NCT00468650|183259766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.88|STANDARD_DEVIATION|37.23|<|0.001||95.0|12.84|26.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||26.91|12.84|<0.001
91684801|NCT00468650|183259767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|57.34|STANDARD_DEVIATION|42.6|<|0.001||95.0|48.93|65.75||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||65.75|48.93|<0.001
91684802|NCT00468650|183259767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.72|STANDARD_DEVIATION|40.3|<|0.001||95.0|62.72|78.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||78.71|62.72|<0.001
91684803|NCT00468650|183259767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.63|STANDARD_DEVIATION|40.78|<|0.001||95.0|62.41|78.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.85|62.41|<0.001
91684804|NCT00468650|183259767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.07|STANDARD_DEVIATION|40.27|<|0.001||95.0|64.16|79.98||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.98|64.16|<0.001
91684805|NCT00468650|183259767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.51|STANDARD_DEVIATION|40.48|<|0.001||95.0|63.48|79.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||79.55|63.48|<0.001
91684806|NCT00468650|183259768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.1|STANDARD_DEVIATION|29.11|<|0.001||95.0|7.58|18.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||18.63|7.58|<0.001
91684807|NCT00468650|183259768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.11|STANDARD_DEVIATION|32.53|<|0.001||95.0|7.84|20.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.37|7.84|<0.001
91684808|NCT00468650|183259768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.47|STANDARD_DEVIATION|31.92|<|0.001||95.0|7.47|19.47||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||19.47|7.47|<0.001
91684809|NCT00468650|183259768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.72|STANDARD_DEVIATION|32.16|<|0.001||95.0|7.61|19.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||19.82|7.61|<0.001
91684810|NCT00468650|183259769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||64.60|49.31|<0.001
91684811|NCT00468650|183259769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
91684812|NCT00468650|183259769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
91684813|NCT00468650|183259769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
91684814|NCT00468650|183259769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
91526948|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7699|TWO_SIDED|95.0|-1.6|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 2 SCCAI score||2.2|-1.6|0.7699
91719180|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.9|||=|0.714|TWO_SIDED|95.0|-8.4|12.2|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 3 vs 1)||12.2|-8.4|= 0.714
91719181|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.5|||=|0.926|TWO_SIDED|95.0|-10.7|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 2 vs 1)||9.7|-10.7|= 0.926
91719182|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-8.7|8.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 5 vs 1)||8.7|-8.7|> 0.999
91719183|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-2.2|||=|0.609|TWO_SIDED|95.0|-10.8|6.4|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 4 vs 1)||6.4|-10.8|= 0.609
91719184|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.8|||=|0.688|TWO_SIDED|95.0|-7.1|10.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 3 vs 1)||10.7|-7.1|= 0.688
91719185|NCT03620162|183331248|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.1|||=|0.336|TWO_SIDED|95.0|-12.6|4.3|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 2 vs 1)||4.3|-12.6|= 0.336
91719186|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.1|||=|0.825|TWO_SIDED|95.0|-11.0|8.8|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group5 vs1)||8.8|-11.0|= 0.825
91719187|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.912|TWO_SIDED|95.0|-10.4|9.3|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group4 vs1)||9.3|-10.4|= 0.912
91719188|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.8|||=|0.074|TWO_SIDED|95.0|-18.3|0.9|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group3 vs1)||0.9|-18.3|= 0.074
91719189|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Percentage of Participants|-3.7|||=|0.458|TWO_SIDED|95.0|-13.4|6.1|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group2 vs1)||6.1|-13.4|= 0.458
91719190|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|2.8|||=|0.568|TWO_SIDED|95.0|-6.8|12.3|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 5 vs1)||12.3|-6.8|= 0.568
91719191|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||=|0.91|TWO_SIDED|95.0|-9.1|10.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 4 vs1)||10.2|-9.1|= 0.910
91719192|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.7|||=|0.354|TWO_SIDED|95.0|-14.5|5.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 3 vs1)||5.2|-14.5|= 0.354
91719193|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.8|||=|0.178|TWO_SIDED|95.0|-16.6|3.1|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 2 vs1)||3.1|-16.6|= 0.178
91719194|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.52|TWO_SIDED|95.0|-6.8|13.5|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 5 vs 1)||13.5|-6.8|= 0.520
91719195|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-10.2|10.2|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 4 vs 1)||10.2|-10.2|> 0.999
91719196|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.2|||=|0.963|TWO_SIDED|95.0|-10.5|10.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 3 vs 1)||10.0|-10.5|= 0.963
91719197|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.2|||=|0.821|TWO_SIDED|95.0|-11.4|9.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 2 vs 1)||9.0|-11.4|= 0.821
91719198|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.836|TWO_SIDED|95.0|-6.1|5.0|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 5 vs 1)||5.0|-6.1|= 0.836
91719199|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.7|||=|0.562|TWO_SIDED|95.0|-4.2|7.6|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 4 vs 1)||7.6|-4.2|= 0.562
91719200|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.6|||=|0.527|TWO_SIDED|95.0|-7.1|3.7|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 3 vs 1)||3.7|-7.1|= 0.527
91719201|NCT03620162|183331249|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.16|TWO_SIDED|95.0|-8.6|1.5|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 2 vs 1)||1.5|-8.6|= 0.160
91719202|NCT03620162|183331250|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 5 vs 1)||2.1|-2.1|
91719203|NCT03620162|183331250|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 4 vs 1)||2.1|-2.1|
91719204|NCT03620162|183331250|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||||TWO_SIDED|95.0|-1.6|3.1||||||Difference in Percentage (Group 3 vs 1)||3.1|-1.6|
91719205|NCT03620162|183331250|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 2 vs 1)||2.1|-2.1|
91719206|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||GMC Ratio: Serotype 1 (Group 4 vs 1)||1.00|0.69|
91719207|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||GMC Ratio: Serotype 1 (Group 3 vs 1)||1.12|0.77|
91719208|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|1.0||||||GMC Ratio: Serotype 1 (Group 2 vs 1)||1.00|0.70|
91719209|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.86|1.19||||||GMC Ratio: Serotype 3 (Group 4 vs 1)||1.19|0.86|
91719210|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.12||||||GMC Ratio: Serotype 3 (Group 3 vs 1)||1.12|0.80|
91719211|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||GMC Ratio: Serotype 3 (Group 2 vs 1)||1.25|0.90|
91719212|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.66|1.0||||||GMC Ratio: Serotype 4 (Group 4 vs 1)||1.00|0.66|
91719213|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.68|1.03||||||GMC Ratio: Serotype 4 (Group 3 vs 1)||1.03|0.68|
91719214|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||GMC Ratio: Serotype 4 (Group 2 vs 1)||1.08|0.72|
91719215|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.98||||||GMC Ratio: Serotype 5 (Group 4 vs 1)||0.98|0.64|
91719216|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||GMC Ratio: Serotype 5 (Group 3 vs 1)||1.29|0.84|
91719217|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.14||||||GMC Ratio: Serotype 5 (Group 2 vs 1)||1.14|0.75|
91719218|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||GMC Ratio: Serotype 6A (Group 4 vs 1)||0.98|0.66|
91719219|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||GMC Ratio: Serotype 6A (Group 3 vs 1)||1.37|0.91|
91719220|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.92|1.36||||||GMC Ratio: Serotype 6A (Group 2 vs 1)||1.36|0.92|
91719221|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.31||||||GMC Ratio: Serotype 6B (Group 4 vs 1)||1.31|0.88|
91684815|NCT00468650|183259770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
91684816|NCT00468650|183259770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
91684817|NCT00468650|183259770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
91684818|NCT00468650|183259770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
91684819|NCT00468650|183259771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.58|STANDARD_DEVIATION|37.77||0.001||95.0|-19.96|-5.2||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-5.20|-19.96|0.0010
91684820|NCT00468650|183259771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.55|STANDARD_DEVIATION|35.04|<|0.001||95.0|-27.47|-13.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-13.64|-27.47|<0.001
91684821|NCT00468650|183259771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.53|STANDARD_DEVIATION|36.64|<|0.001||95.0|-29.88|-15.18||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-15.18|-29.88|<0.001
91684822|NCT00468650|183259771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.44|STANDARD_DEVIATION|36.06|<|0.001||95.0|-28.49|-14.39||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-14.39|-28.49|<0.001
91684823|NCT00468650|183259771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.86|STANDARD_DEVIATION|36.29|<|0.001||95.0|-29.03|-14.7||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-14.70|-29.03|<0.001
91684824|NCT00468650|183259772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.79|STANDARD_DEVIATION|22.58||0.0021||95.0|-11.06|-2.52||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-2.52|-11.06|0.0021
91684825|NCT00468650|183259772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|STANDARD_DEVIATION|23.02||0.0027||95.0|-11.26|-2.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-2.43|-11.26|0.0027
91684826|NCT00468650|183259772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.43|STANDARD_DEVIATION|24.2||0.0015||95.0|-11.97|-2.9||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-2.90|-11.97|0.0015
91684827|NCT00468650|183259772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.57|STANDARD_DEVIATION|24.4||0.0015||95.0|-12.18|-2.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-2.96|-12.18|0.0015
91684828|NCT00468650|183259773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.87|STANDARD_DEVIATION|34.44||0.0045||95.0|-16.6|-3.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-3.14|-16.60|0.0045
91684829|NCT00468650|183259773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.74|STANDARD_DEVIATION|32.8|<|0.001||95.0|-18.22|-5.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-5.27|-18.22|<0.001
91684830|NCT00468650|183259773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.78|STANDARD_DEVIATION|33.56|<|0.001||95.0|-19.51|-6.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-6.05|-19.51|<0.001
91684831|NCT00468650|183259773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.13|STANDARD_DEVIATION|33.94|<|0.001||95.0|-19.76|-6.5||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-6.50|-19.76|<0.001
91684832|NCT00468650|183259773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.4|STANDARD_DEVIATION|33.13|<|0.001||95.0|-18.94|-5.86||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-5.86|-18.94|<0.001
91487369|NCT02642029|182847282|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.035||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.035
91684833|NCT00468650|183259774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|STANDARD_DEVIATION|22.0||0.2567||95.0|-6.55|1.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.77|-6.55|0.2567
91684834|NCT00468650|183259774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.91|STANDARD_DEVIATION|20.73||0.3435||95.0|-5.88|2.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.07|-5.88|0.3435
91684835|NCT00468650|183259774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.71|STANDARD_DEVIATION|22.28||0.2||95.0|-6.89|1.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.46|-6.89|0.2000
91684836|NCT00468650|183259774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.76|STANDARD_DEVIATION|22.48||0.2||95.0|-7.01|1.48||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.48|-7.01|0.2000
91684837|NCT00468650|183259775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.82|STANDARD_DEVIATION|56.75||0.0558||95.0|-21.91|0.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||0.27|-21.91|0.0558
91684838|NCT00468650|183259775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-29.16|STANDARD_DEVIATION|59.81|<|0.001||95.0|-40.96|-17.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-17.35|-40.96|<0.001
91684839|NCT00468650|183259775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.79|STANDARD_DEVIATION|60.9|<|0.001||95.0|-43.0|-18.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-18.58|-43.00|<0.001
91684840|NCT00468650|183259775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.27|STANDARD_DEVIATION|61.7|<|0.001||95.0|-42.33|-18.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-18.21|-42.33|<0.001
91684841|NCT00468650|183259775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.87|STANDARD_DEVIATION|60.54|<|0.001||95.0|-42.82|-18.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-18.92|-42.82|<0.001
91684842|NCT00468650|183259776|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-18.36|STANDARD_DEVIATION|46.03|<|0.001||95.0|-27.05|-9.66||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-9.66|-27.05|<0.001
91684843|NCT00468650|183259776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.16|STANDARD_DEVIATION|45.24|<|0.001||95.0|-30.84|-13.49||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-13.49|-30.84|<0.001
91684844|NCT00468650|183259776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.28|STANDARD_DEVIATION|45.86|<|0.001||95.0|-28.87|-11.69||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-11.69|-28.87|<0.001
91684845|NCT00468650|183259776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.65|STANDARD_DEVIATION|46.2|<|0.001||95.0|-29.38|-11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-11.92|-29.38|<0.001
91684846|NCT00468650|183259777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|33.27|STANDARD_DEVIATION|41.43|<|0.001||95.0|25.17|41.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||41.36|25.17|<0.001
91684847|NCT00468650|183259777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|61.45|STANDARD_DEVIATION|44.77|<|0.001||95.0|52.61|70.29||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||70.29|52.61|<0.001
91684848|NCT00468650|183259777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|66.1|STANDARD_DEVIATION|45.15|<|0.001||95.0|57.05|75.16||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||75.16|57.05|<0.001
91684849|NCT00468650|183259777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|64.84|STANDARD_DEVIATION|45.7|<|0.001||95.0|55.91|73.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||73.77|55.91|<0.001
91684850|NCT00468650|183259777|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.13|STANDARD_DEVIATION|45.56|<|0.001||95.0|56.14|74.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||74.12|56.14|<0.001
91684851|NCT00468650|183259778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.53|STANDARD_DEVIATION|40.19|<|0.001||95.0|19.94|35.13||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||35.13|19.94|<0.001
91684852|NCT00468650|183259778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.92|STANDARD_DEVIATION|41.9|<|0.001||95.0|22.89|38.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||38.95|22.89|<0.001
91684853|NCT00468650|183259778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.43|STANDARD_DEVIATION|41.88|<|0.001||95.0|22.59|38.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||38.27|22.59|<0.001
91684854|NCT00468650|183259778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.98|STANDARD_DEVIATION|42.06|<|0.001||95.0|23.04|38.93||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||38.93|23.04|<0.001
91684855|NCT00468650|183259779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.45|STANDARD_DEVIATION|46.1|<|0.001||95.0|13.44|31.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||31.46|13.44|<0.001
91684856|NCT00468650|183259779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.3|STANDARD_DEVIATION|42.15|<|0.001||95.0|23.97|40.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||40.62|23.97|<0.001
91719222|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.32||||||GMC Ratio: Serotype 6B (Group 3 vs 1)||1.32|0.88|
91719223|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.02|1.49||||||GMC Ratio: Serotype 6B (Group 2 vs 1)||1.49|1.02|
91719224|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.64|0.95||||||GMC Ratio: Serotype 7F (Group 4 vs 1)||0.95|0.64|
91719225|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||GMC Ratio: Serotype 7F (Group 3 vs 1)||1.21|0.81|
91719226|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.92|1.35||||||GMC Ratio: Serotype 7F (Group 2 vs 1)||1.35|0.92|
91719227|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||GMC Ratio: Serotype 9V (Group 4 vs 1)||1.01|0.70|
91719228|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||GMC Ratio: Serotype 9V (Group 3 vs 1)||1.06|0.73|
91719229|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.79|1.13||||||GMC Ratio: Serotype 9V (Group 2 vs 1)||1.13|0.79|
91684857|NCT00468650|183259779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.31|STANDARD_DEVIATION|43.52|<|0.001||95.0|26.59|44.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||44.04|26.59|<0.001
91684858|NCT00468650|183259779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.57|STANDARD_DEVIATION|43.48|<|0.001||95.0|26.07|43.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||43.07|26.07|<0.001
91684859|NCT00468650|183259779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.26|STANDARD_DEVIATION|43.29|<|0.001||95.0|25.72|42.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||42.81|25.72|<0.001
91684860|NCT00468650|183259780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.18|STANDARD_DEVIATION|29.45||0.0014||95.0|3.61|14.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||14.74|3.61|0.0014
91684861|NCT00468650|183259780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.75|STANDARD_DEVIATION|29.26||0.0025||95.0|3.15|14.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||14.36|3.15|0.0025
91684862|NCT00468650|183259780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.15|STANDARD_DEVIATION|31.11|<|0.001||95.0|4.32|15.97||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||15.97|4.32|<0.001
91684863|NCT00468650|183259780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.33|STANDARD_DEVIATION|31.36|<|0.001||95.0|4.41|16.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||16.26|4.41|<0.001
91719230|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.83|1.28||||||GMC Ratio: Serotype 14 (Group 4 vs 1)||1.28|0.83|
91684864|NCT00345943|183259783|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.|BN versus HC group effect|Growth curve models examined the following: group (BN versus HC) differences in cortical thickness (CT) at baseline; group differences in the rate of change in CT over time; and the persistence of group differences in CT over time.||||.03
91684865|NCT00345943|183259783|OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.047|<|0.05|TWO_SIDED|95.0|-0.04|0.15|||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.||Growth curve models examined the following: group (BN versus HC) differences in conflict-related BOLD signal at baseline; group differences in the rate of change in conflict-related BOLD signal over time; and the persistence of group differences in conflict-related BOLD signal over time.||0.15|-0.04|<.05
91684866|NCT00673387|183259838|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||<0.0001
91719231|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.15|1.78||||||GMC Ratio: Serotype 14 (Group 3 vs 1)||1.78|1.15|
91719232|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.13|1.71||||||GMC Ratio: Serotype 14 (Group 2 vs 1)||1.71|1.13|
91719233|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.07|||||TWO_SIDED|95.0|0.88|1.3||||||GMC Ratio: Serotype 18C (Group 4 vs 1)||1.30|0.88|
91719234|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.44|||||TWO_SIDED|95.0|1.18|1.76||||||GMC Ratio: Serotype 18C (Group 3 vs 1)||1.76|1.18|
91684867|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.0002||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0002
91684868|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.0004||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0004
91684869|NCT00673387|183259838|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||<0.0001
91684870|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||0.0001
91684871|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.251||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2510
91684872|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.3433||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3433
91684873|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.4503||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4503
91684874|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.2122||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2122
91684875|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.2232||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2232
91526949|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3869|TWO_SIDED|95.0|-1.1|2.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 2 SCCAI score||2.8|-1.1|0.3869
91684876|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.4207||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4207
91684877|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.5375||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.5375
91719235|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.25|1.83||||||GMC Ratio: Serotype 18C (Group 2 vs 1)||1.83|1.25|
91719236|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.69|1.01||||||GMC Ratio: Serotype 19A (Group 4 vs 1)||1.01|0.69|
91526950|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.6695|TWO_SIDED|95.0|-2.4|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 2 SCCAI score||1.5|-2.4|0.6695
91684878|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.6633||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.6633
91684879|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.3667||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3667
91684880|NCT00673387|183259838|SUPERIORITY_OR_OTHER|||||||0.372||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3720
91684881|NCT00673387|183259842|SUPERIORITY_OR_OTHER|||||||0.0404|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate||||0.0404
91684882|NCT00673387|183259842|SUPERIORITY_OR_OTHER|||||||0.0265|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0265
91684883|NCT00673387|183259842|SUPERIORITY_OR_OTHER|||||||0.1357|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.1357
91684884|NCT00673387|183259842|SUPERIORITY_OR_OTHER|||||||0.0409|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0409
91684885|NCT00673387|183259842|SUPERIORITY_OR_OTHER|||||||0.0082|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0082
91684886|NCT00673387|183259846|SUPERIORITY_OR_OTHER|||||||0.0464|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0464
91684887|NCT00673387|183259846|SUPERIORITY_OR_OTHER|||||||0.0647|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0647
91684888|NCT00673387|183259846|SUPERIORITY_OR_OTHER|||||||0.069|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0690
91684889|NCT00673387|183259846|SUPERIORITY_OR_OTHER|||||||0.3717|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.3717
91684890|NCT00673387|183259846|SUPERIORITY_OR_OTHER|||||||0.0327|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0327
91684891|NCT00673387|183259847|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0049
91684892|NCT00673387|183259847|SUPERIORITY_OR_OTHER|||||||0.0047|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0047
91684893|NCT00673387|183259847|SUPERIORITY_OR_OTHER|||||||0.0046|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0046
91684894|NCT00673387|183259847|SUPERIORITY_OR_OTHER|||||||0.0257|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0257
91684895|NCT00673387|183259847|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0014
91684896|NCT00673387|183259848|SUPERIORITY_OR_OTHER|||||||0.0222|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0222
91684897|NCT00673387|183259848|SUPERIORITY_OR_OTHER|||||||0.0128|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0128
91684898|NCT00673387|183259848|SUPERIORITY_OR_OTHER|||||||0.0122|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0122
91684899|NCT00673387|183259848|SUPERIORITY_OR_OTHER|||||||0.0073|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0073
91719237|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||GMC Ratio: Serotype 19A (Group 3 vs 1)||1.07|0.72|
91719238|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.13||||||GMC Ratio: Serotype 19A (Group 2 vs 1)||1.13|0.77|
91684900|NCT00673387|183259848|SUPERIORITY_OR_OTHER|||||||0.0034|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0034
91684901|NCT00960115|183259865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.828|TWO_SIDED|95.0|0.614|1.479||This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05.|Log Rank||Cox proportional hazards regression model|||1.479|0.614|0.828
91684902|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|1.76|1.88||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.88|1.76|<.0001
91684903|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.81|2.0||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.00|1.81|<.0001
91684904|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.29|1.44||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.44|1.29|<.0001
91684905|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.2|2.33||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.33|2.20|<.0001
91684906|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.69|1.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.85|1.69|<.0001
91684907|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.85|2.06||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.06|1.85|<.0001
91684908|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|2.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.69|2.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.85|2.69|<.0001
91487370|NCT02642029|182847282|OTHER||beta coefficient for auditory hallucinat|0.00195||||0.028|TWO_SIDED|95.0|0.00021|0.00369||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, auditory hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00369|0.00021|0.028
91684909|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|2.49|2.67||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement - Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.67|2.49|<.0001
91684910|NCT03996447|183259892|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.84|2.95||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.95|2.84|<.0001
91684911|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.06|0.02||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.02|-0.06|<0.0001
91684912|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.04|0.11||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.11|-0.04|<0.0001
91684913|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.01|0.05|||t-test, 2 sided|||Criterion: Border delineation; Reader 3||0.05|-0.01|<0.0001
91684914|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.04|0.03|||t-test, 2 sided|||Criterion: Internal morphology; Reader 1||0.03|-0.04|<0.0001
91684915|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.05|0.09|||t-test, 2 sided|||Criterion: Internal morphology; Reader 2||0.09|-0.05|<0.0001
91684916|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.01|0.08|||t-test, 2 sided|||Criterion: Internal morphology; Reader 3||0.08|0.01|<0.0001
91684917|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.0001|TWO_SIDED|95.0|-0.04|0.07|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1||0.07|-0.04|0.0001
91684918|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.03|0.12|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2||0.12|-0.03|<0.0001
91684919|NCT03996447|183259893|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.03|0.15|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3||0.15|0.03|<0.0001
91684920|NCT00369486|183259911|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||Adjusted for baseline central subfield thickness|repeated measures least sq. regression|Models adjusted for baseline values and for correlated data from subjects with two study eyes.||Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.||||0.46
91684921|NCT00369486|183259912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.04||95.0|0.2|1.0|||generalized estimating equations|||Analysis combined posterior and anterior injection + laser groups to compare with laser only.||1.0|0.2|0.04
91684922|NCT00369486|183259912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.63||95.0|0.5|2.9|||generalized estimating equations|||Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.||2.9|0.5|0.63
91719239|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.96|||||TWO_SIDED|95.0|0.81|1.15||||||GMC Ratio: Serotype 19F (Group 4 vs 1)||1.15|0.81|
91719240|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||GMC Ratio: Serotype 19F (Group 3 vs 1)||1.26|0.88|
91719241|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||GMC Ratio: Serotype 19F (Group 2 vs 1)||1.21|0.86|
91719242|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||GMC Ratio: Serotype 23F (Group 4 vs 1)||0.96|0.61|
91719243|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99||||||GMC Ratio: Serotype 23F (Group 3 vs 1)||0.99|0.63|
91719244|NCT03620162|183331251|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||GMC Ratio: Serotype 23F (Group 2 vs 1)||1.17|0.76|
91719245|NCT03620162|183331252|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (Group 5/Group 1+Group 2) to be \>-10 percentage points.|Difference in Percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-3.7|2.0|||Miettinen & Nurminen method|||Difference in Percentage (Group 5 vs Group 1+2)||2.0|-3.7|< 0.001
91719246|NCT03620162|183331253|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT ratio (Group 5/Group 1+Group 2) to be \>0.5.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.7|1.34|||ANCOVA|||GMT Ratio (Group 5 vs Group 1+2)||1.34|0.70|< 0.001
91719247|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.86||||||GMC Ratio: Serotype 1 (Group 5 vs 1)||0.86|0.60|
91719248|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.04|1.44||||||GMC Ratio: Serotype 3 (Group 5 vs 1)||1.44|1.04|
91719249|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.73|1.1||||||GMC Ratio: Serotype 4 (Group 5 vs 1)||1.10|0.73|
91719250|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||GMC Ratio: Serotype 5 (Group 5 vs 1)||0.97|0.64|
91719251|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.69|||||TWO_SIDED|95.0|0.57|0.84||||||GMC Ratio: Serotype 6A (Group 5 vs 1)||0.84|0.57|
91719252|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.15||||||GMC Ratio: Serotype 6B (Group 5 vs 1)||1.15|0.78|
91719253|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.55|0.82||||||GMC Ratio: Serotype 7F (Group 5 vs 1)||0.82|0.55|
91719254|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.18||||||GMC Ratio: Serotype 9V (Group 5 vs 1)||1.18|0.82|
91719255|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||GMC Ratio: Serotype 14 (Group 5 vs 1)||1.07|0.70|
91719256|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||GMC Ratio: Serotype 18C (Group 5 vs 1)||1.25|0.85|
91719257|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||GMC Ratio: Serotype 19A (Group 5 vs 1)||0.95|0.65|
91719258|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||GMC Ratio: Serotype 19F (Group 5 vs 1)||1.02|0.72|
91719259|NCT03620162|183331256|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.59|0.91||||||GMC Ratio: Serotype 23F (Group 5 vs 1)||0.91|0.59|
91719260|NCT01258049|183331295|SUPERIORITY_OR_OTHER||Percentage Difference|54.85|||<|0.005|TWO_SIDED|95.0|42.25|67.45|||Regression, Logistic|||In ART003, the parasite success rate for quinine was 67.7%. On the assumption that the parasite success rate was 70% for quinine in this study and in order to demonstrate that ArTiMist™ is superior to quinine by at least 20% the success rate for ArTiMist™ should be at least 90%. Using these figures, and assuming a power of 80%, an alpha of 0.05 (two sided) and based on an equal allocation to the ArTiMist™ and quinine treatment arms, the number of subjects (n) required on each treatment was 59.||67.45|42.25|<0.005
91719261|NCT01258049|183331296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.97|||<|0.05|TWO_SIDED|95.0|-62.22|-15.72|||ANCOVA|||||-15.72|-62.22|<0.05
91719262|NCT01258049|183331297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.91|||<|0.005|TWO_SIDED|95.0|-17.38|-8.44|||ANCOVA|||||-8.44|-17.38|<0.005
91719263|NCT01258049|183331298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.16|||<|0.005|TWO_SIDED|95.0|-11.71||||Regression, Cox|||||- 6.61|-11.71|<0.005
91719264|NCT01258049|183331299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.02|||<|0.005|TWO_SIDED|95.0|27.05|80.98|||ANCOVA|||||80.98|27.05|<0.005
91719265|NCT01258049|183331300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|174.09||||0.06|TWO_SIDED|95.0|-10.44|358.61|||ANCOVA||mean parasite counts increased in the first 12 hours for patients on quinine treatment|||358.61|-10.44|0.06
91719266|NCT01258049|183331301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.86|TWO_SIDED|95.0|-10.16|12.08|||Regression, Cox|||||12.08|-10.16|0.86
91719267|NCT01258049|183331302|SUPERIORITY_OR_OTHER||Percentage Difference|0.99||||0.99|TWO_SIDED|95.0|0.42|2.36|||Regression, Logistic|||||2.36|0.42|0.99
91719268|NCT01258049|183331305|SUPERIORITY_OR_OTHER||Percentage Difference|55.01|||<|0.005|TWO_SIDED|95.0|42.44|67.58|||Regression, Linear|||||67.58|42.44|<0.005
91719269|NCT00961415|183331311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.69|||Log Rank|||||0.69|0.37|<0.001
91719270|NCT00961415|183331312|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.23|TWO_SIDED|95.0|0.47|1.2|||Log Rank|||||1.20|0.47|0.230
91719271|NCT00961415|183331314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.006|TWO_SIDED|95.0|0.34|0.84|||Log Rank|||||0.84|0.34|0.006
91719272|NCT00961415|183331315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.38|0.7|||Log Rank|||||0.70|0.38|<0.001
91719273|NCT02309359|183331319|OTHER|Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).||||||0.172|||||||Cochran-Armitage trend test|||The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.||||0.172
91719274|NCT04649359|183331376|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 30%.||||<0.0001
91719275|NCT04649359|183331376|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort B was 15%.||||<0.0001
91719276|NCT04649359|183331377|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 12%.||||<0.0001
91719277|NCT04649359|183331378|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 38%.||||<0.0001
91719278|NCT03307174|183331398|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91719279|NCT05911841|183331412|SUPERIORITY||Mean Difference (Final Values)|-12.0|||||TWO_SIDED|95.0|-30.6|6.6||||||||6.6|-30.6|
91719280|NCT05911841|183331412|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-19.4|19.2||||||||19.2|-19.4|
91719281|NCT05911841|183331412|SUPERIORITY||Mean Difference (Final Values)|-14.9|||||TWO_SIDED|95.0|-31.6|1.7||||||||1.7|-31.6|
91719282|NCT05911841|183331413|SUPERIORITY||Mean Difference (Final Values)|-4.4|||||TWO_SIDED|95.0|-17.6|8.7||||||||8.7|-17.6|
91719283|NCT05911841|183331413|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-12.3|15.1||||||||15.1|-12.3|
91719284|NCT05911841|183331413|SUPERIORITY||Mean Difference (Final Values)|-9.9|||||TWO_SIDED|95.0|-21.8|1.9||||||||1.9|-21.8|
91719285|NCT01981616|183331446|NON_INFERIORITY_OR_EQUIVALENCE|"With 55 evaluable participants in each group, the study would have at least 80% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% confidence interval (CI) on the difference in proportions between vedolizumab- and placebo-treated participants, assuming a 90% seroconversion rate (anti-HBs of 10 IU/L) for hepatitis B vaccine.~If the lower bound of this interval was less than -15% (ie, more negative), then the null hypothesis was accepted."|Difference from placebo|-1.8|||||TWO_SIDED|95.0|-12.7|9.1||||||||9.1|-12.7|
91719286|NCT01981616|183331447|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 55 evaluable subjects in the vedolizumab 750 mg IV group and 55 evaluable participants in the placebo group provided at least 71% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% CI on the difference in proportions between vedolizumab- and placebo-treated participants, assuming an 85% seroconversion rate to the oral cholera vaccine (Dukoral).|Difference from placebo|-14.2|||||TWO_SIDED|95.0|-24.6|-3.9||||||||-3.9|-24.6|
91719287|NCT05079321|183331505|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
91719288|NCT05079321|183331506|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
91719289|NCT05079321|183331507|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
91719290|NCT05079321|183331508|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
91719291|NCT05079321|183331509|OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
91719292|NCT05079321|183331510|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
91719293|NCT05079321|183331511|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
91719294|NCT05079321|183331512|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
91719295|NCT05079321|183331514|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
91719296|NCT05079321|183331515|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
91719297|NCT05079321|183331516|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
91719298|NCT05079321|183331517|OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
91719299|NCT05079321|183331518|OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
91719300|NCT05079321|183331519|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
91487371|NCT02642029|182847283|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.748||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.748
91684923|NCT00369486|183259913|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||repeated measures least sq. regression|Adjusted for baseline values and for the correlated data from subjects with two study eyes.||Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.||||0.94
91684924|NCT03888066|183259923|SUPERIORITY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.015|<|0.001|TWO_SIDED|95.0|-0.128|-0.067|||Mixed model for repeated measures (MMRM)|||Difference in adjusted mean changes (SE)||-0.067|-0.128|< 0.001
91684925|NCT03888066|183259924|SUPERIORITY||Hazard Ratio (HR)|0.63|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
91684926|NCT03888066|183259925|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
91684927|NCT03888066|183259926|SUPERIORITY||Annualized event rate ratio|0.658|||<|0.001|TWO_SIDED|95.0|0.534|0.81|||Negative binomial model adjusted for cov|||"NBMAC Annualized event RR patiromer vs placebo.~NBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer.~NBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.81|0.534|< 0.001
91684928|NCT03888066|183259927|SUPERIORITY||Win Ratio|1.526|||<|0.001|TWO_SIDED|95.0|1.231|1.906|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers."||1.906|1.231|<0.001
91684929|NCT03888066|183259927|SUPERIORITY||Win Ratio|0.914|||=|0.744|TWO_SIDED|95.0|0.526|1.578|||Win Ratio|||"Win ratio CV death and hospitalization.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.578|0.526|= 0.744
91684930|NCT03888066|183259928|SUPERIORITY||Win Ratio|1.248|||=|0.048|TWO_SIDED|95.0|1.003|1.564|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.564|1.003|= 0.048
91684931|NCT02207634|183259980|NON_INFERIORITY|The non-inferiority margin was 0.19, calculated as 20% of the observed common standard deviation, which was estimated from observations in the placebo group by a repeated measured mixed-effect linear model with visit as a covariate. If the upper bound of the 95% CI for the difference between the placebo and evolocumab group in mean change from baseline for Z score averaged across the visits was less than the non-inferiority margin non-inferiority criteria were met.|Treatment Difference|0.0072|STANDARD_ERROR_OF_MEAN|0.0375|||TWO_SIDED|95.0|-0.0664|0.0808||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening low-density lipoprotein cholesterol \[LDL-C\] and geographical region), age, education level, baseline SWM strategy index Z score, treatment group, visit, and treatment by visit interaction.||0.0808|-0.0664|
91684932|NCT02207634|183259981|OTHER||Treatment Difference|0.0333|STANDARD_ERROR_OF_MEAN|0.0363|||TWO_SIDED|95.0|-0.0378|0.1045||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline SWM between-errors Z score, treatment group, visit, and treatment by visit interaction.||0.1045|-0.0378|
91684933|NCT02207634|183259982|OTHER||Treatment Difference|0.0226|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.0422|0.0873||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline PAL total errors adjusted Z score, treatment group, visit, and treatment by visit interaction.||0.0873|-0.0422|
91719301|NCT01081626|183331520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0135||||0.956|TWO_SIDED|95.0|-0.1325|0.1637|||Chi-squared, Corrected|||||0.1637|-0.1325|0.9560
91719302|NCT01081626|183331521|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.7924|TWO_SIDED|95.0|0.7642|1.549|||Chi-squared|||||1.5490|0.7642|0.7924
91526951|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.5152|TWO_SIDED|95.0|-1.4|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 2 SCCAI score||2.7|-1.4|0.5152
91719303|NCT01081626|183331525|SUPERIORITY_OR_OTHER|||||||0.5331||95.0|||||Chi-squared|||||||0.5331
91719304|NCT01081626|183331526|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.015||||0.9351|TWO_SIDED|95.0|0.7175|1.435|||Chi-squared|||||1.4350|0.7175|0.9351
91719305|NCT00032591|183331551|NON_INFERIORITY_OR_EQUIVALENCE|A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years.|Hazard Ratio (HR)|0.88||||0.14|||||||Log Rank|||The null hypothesis was the hazard ratio was equal to 1.||||0.14
91719306|NCT05172609|183331628|EQUIVALENCE|Margin difference of 1 standard deviation (SD) or higher was considered evidence of non-equivalence comparison||||||0.47|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for AIM||||.47
91719307|NCT05172609|183331629|EQUIVALENCE|Margin difference of 1 SD or higher was considered evidence of non-equivalence comparison||||||0.88|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for FIM||||.88
91719308|NCT05172609|183331630|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 3: two weeks after completing the training||||.46
91719309|NCT05172609|183331630|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 4: 12 weeks after completing the training||||.40
91719310|NCT05172609|183331630|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 3: two weeks after completing the training||||.56
91719311|NCT05172609|183331630|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 4: 12 weeks after completing the training||||.68
91719312|NCT05172609|183331630|SUPERIORITY|||||||0.87|||||||ANCOVA|||Repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS screening at timepoints 1, 3, and 4||||.87
91719313|NCT05172609|183331630|SUPERIORITY|||||||0.43|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS planning at timepoints 1, 3, and 4||||.43
91719314|NCT05172609|183331631|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 3: two weeks after completing the training||||.59
91719315|NCT05172609|183331631|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 4: 12 weeks after completing the training||||.59
91719316|NCT05172609|183331631|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 3: two weeks after completing the training||||.25
91719317|NCT05172609|183331631|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 4: 12 weeks after completing the training||||.35
91719318|NCT05172609|183331631|SUPERIORITY|||||||0.88|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy screening at timepoints 1, 3, and 4||||.88
91719319|NCT05172609|183331631|SUPERIORITY|||||||0.71|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy intervening at timepoints 1, 3, and 4||||.71
91719320|NCT05172609|183331632|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 3: two weeks after completing the training||||.88
91719321|NCT05172609|183331632|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 4: 12 weeks after completing the training||||.55
91719322|NCT05172609|183331632|SUPERIORITY|||||||0.36|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: CSR screening at timepoints 1, 3, and 4||||.36
91719323|NCT05172609|183331633|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 3: two weeks after completing the training||||.24
91719324|NCT05172609|183331633|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 4: 12 weeks after completing the training||||.88
91719325|NCT05172609|183331633|SUPERIORITY|||||||0.1|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SPIRS at timepoints 3 and 4||||.10
91719326|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.62||||0.055|TWO_SIDED|90.0|0.44|0.88||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.44|0.055
91719327|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.64|||<|0.001|TWO_SIDED|90.0|0.55|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.55|<0.001
91719328|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.68||||0.22|TWO_SIDED|90.0|0.44|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.44|0.22
91719329|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.6|||<|0.001|TWO_SIDED|90.0|0.49|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.49|<0.001
91719330|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.76|||<|0.05|TWO_SIDED|90.0|0.64|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.64|<0.05
91719331|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.71|||<|0.05|TWO_SIDED|90.0|0.57|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.57|<0.05
91719332|NCT00042289|183331653|SUPERIORITY||Geometric mean ratio|0.98||||0.78|TWO_SIDED|90.0|0.71|1.35||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.35|0.71|0.78
91719333|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.42|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.42|<0.05
91719334|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.63|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.63|<0.05
91719335|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|0.58||||0.03|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.03
91719336|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|0.67||||0.001|TWO_SIDED|90.0|0.51|0.89||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.51|0.001
91684934|NCT02207634|183259983|OTHER||Treatment Difference|0.0727|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.0022|0.1477||||||A repeated measures mixed-effect linear model was used to estimate treatment difference ( placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline RTI median 5-choice reaction time Z score, treatment group, visit, and treatment by visit interaction.||0.1477|-0.0022|
91684935|NCT02640482|183260047|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate noninferiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of using a single binomial proportion a one-sample test for superiority).||100.0|98.5|
91684936|NCT02640482|183260048|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 95% to achieve superiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate superiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of a single binomial proportion using a one-sample test for superiority).||100.0|98.5|
91684937|NCT00113763|183260059|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||<0.0001
91684938|NCT00113763|183260060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.806||||||This analysis was conducted contingent on a statistically significant difference in the primary outcome, and adjusted to an a priori threshold for statistical significance at a 4% level for a multiple comparison involving objective tumor response|Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||0.806
91684939|NCT03743415|183260081|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.16||0.81|TWO_SIDED|95.0|-2.5|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of the symptom index, adjusting for baseline value.|Mean of SMSH alone minus mean of SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||1.96|-2.50|.81
91684940|NCT03743415|183260081|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|2.07||0.78|TWO_SIDED|95.0|-4.65|3.49||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|The model included adjustment for baseline value of the symptom index.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||3.49|-4.65|.78
91684941|NCT03743415|183260081|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.76||0.27|TWO_SIDED|95.0|-0.66|2.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||2.32|-0.66|.27
91684942|NCT03743415|183260081|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|1.35||0.19|TWO_SIDED|95.0|-0.88|4.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||4.39|-0.88|.19
91684943|NCT03743415|183260082|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|2.46||0.53|TWO_SIDED|95.0|-3.3|6.36||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||6.36|-3.30|.53
91684944|NCT03743415|183260082|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|3.92||0.97|TWO_SIDED|95.0|-5.7|9.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||9.68|-5.70|.97
91684945|NCT03743415|183260082|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.94||0.31|TWO_SIDED|95.0|-1.83|5.75||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||5.75|-1.83|.31
91684946|NCT03743415|183260082|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED|95.0|-2.13|8.74||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||8.74|-2.13|.61
91684947|NCT03743415|183260083|SUPERIORITY|Key parameter was the difference between arms at week 13.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.14||0.44|TWO_SIDED|95.0|-3.12|1.35||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.35|-3.12|.44
91684948|NCT03743415|183260083|SUPERIORITY|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|1.15||0.95|TWO_SIDED|95.0|-2.32|2.18||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.||2.18|-2.32|.95
91719337|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|1.34||||0.0684|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.0684
91719338|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|0.58|||<|0.05|TWO_SIDED|90.0|0.49|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.49|<0.05
91719339|NCT00042289|183331654|SUPERIORITY||Geometric mean ratio|0.6|||<|0.05|TWO_SIDED|90.0|0.53|0.68||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.53|<0.05
91719340|NCT00042289|183331655|SUPERIORITY||Geometric mean ratio|0.72||||0.008|TWO_SIDED|90.0|0.6|0.88||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||0.88|0.60|0.008
91719341|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.63||||0.002|TWO_SIDED|90.0|0.52|0.75||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.75|0.52|0.002
91719342|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.71||||0.0003|TWO_SIDED|90.0|0.63|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.63|0.0003
91719343|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.57||||0.09|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.09
91719344|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.67||||0.004|TWO_SIDED|90.0|0.54|0.82||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.82|0.54|0.004
91719345|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.79||||0.27|TWO_SIDED|90.0|0.5|1.27||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.27|0.50|0.27
91719346|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.86||||0.7|TWO_SIDED|90.0|0.66|1.12||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.66|0.70
91719347|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.62||||0.46|TWO_SIDED|90.0|0.29|1.34||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.34|0.29|0.46
91719348|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.94||||0.5|TWO_SIDED|90.0|0.63|1.39||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.39|0.63|0.50
91526952|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.4507|TWO_SIDED|95.0|-2.4|1.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 2 SCCAI score||1.1|-2.4|0.4507
91719349|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.76|||<|0.1|TWO_SIDED|90.0|0.57|1.0||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.0|0.57|<0.10
91719350|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.56|||<|0.1|TWO_SIDED|90.0|0.42|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.42|<0.10
91719351|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.47|||<|0.1|TWO_SIDED|90.0|0.33|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.33|<0.10
91719352|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.44|||<|0.1|TWO_SIDED|90.0|0.36|0.54||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.54|0.36|<0.10
91719353|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.74||||0.1875|TWO_SIDED|90.0|0.53|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.53|0.1875
91719354|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.46||||0.1563|TWO_SIDED|90.0|0.19|1.11||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.11|0.19|0.1563
91684949|NCT03743415|183260083|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.96||0.97|TWO_SIDED|95.0|-1.85|1.93||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.93|-1.85|.97
91684950|NCT03743415|183260083|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.96||0.74|TWO_SIDED|95.0|-1.56|2.2||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.20|-1.56|.74
91684951|NCT03743415|183260084|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|2.31||0.98|TWO_SIDED|95.0|-4.49|4.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus mean of SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.58|-4.49|.98
91684952|NCT03743415|183260084|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.34||0.7|TWO_SIDED|95.0|-5.48|3.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.68|-5.48|.70
91684953|NCT03743415|183260084|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.85||0.27|TWO_SIDED|95.0|-5.62|1.62||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.62|-5.62|.27
91684954|NCT03743415|183260084|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.84||0.91|TWO_SIDED|95.0|-3.4|3.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.81|-3.40|.91
91684955|NCT03743415|183260085|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|1.06||0.06|TWO_SIDED|95.0|-3.98|0.19||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.19|-3.98|.06
91684956|NCT03743415|183260085|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.0||0.09|TWO_SIDED|95.0|-3.81|0.11||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.11|-3.81|.09
91684957|NCT03743415|183260085|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.97||0.89|TWO_SIDED|95.0|-1.77|2.04||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.04|-1.77|.89
91719355|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.94||||0.241|TWO_SIDED|90.0|0.85|1.03||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.85|0.241
91719356|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|1.09||||0.837|TWO_SIDED|90.0|0.9|1.32||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.32|0.90|0.837
91526953|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8707|TWO_SIDED|95.0|-1.9|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 3 SCCAI score||2.3|-1.9|0.8707
91684958|NCT03743415|183260085|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.96||0.47|TWO_SIDED|95.0|-1.2|2.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.58|-1.20|.47
91684959|NCT03743415|183260086|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|1.94||0.45|TWO_SIDED|95.0|-5.22|2.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.39|-5.22|.45
91684960|NCT03743415|183260086|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.97||0.82|TWO_SIDED|95.0|-3.59|4.12||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.12|-3.59|.82
91684961|NCT03743415|183260086|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.13|4.23||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.23|-3.13|.77
91684962|NCT03743415|183260086|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|1.87||0.86|TWO_SIDED|95.0|-3.98|3.34||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.34|-3.98|.86
91684963|NCT01917214|183260092|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Log Rank|||||||0.0308
91684964|NCT01696058|183260096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.135|||Mixed Model Repeated Measure|||Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).||0.135|0.078|<.0001
91684965|NCT01696058|183260097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.014|0.065|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).||0.065|0.014|0.0029
91684966|NCT01696058|183260098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.854|STANDARD_ERROR_OF_MEAN|0.461|<|0.0001|TWO_SIDED|95.0|-2.757|-0.951|||ANCOVA|||"Results are from ANCOVA model. Fixed effects include study, treatment and baseline.~Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039)."||-0.951|-2.757|<.0001
91684967|NCT01696058|183260099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.071|0.129|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.129|0.071|<.0001
91684968|NCT01696058|183260100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.072|0.164|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.164|0.072|<.0001
91684969|NCT01696058|183260101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.057|0.152|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.152|0.057|<.0001
91684970|NCT01696058|183260102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.022||0.1156|TWO_SIDED|95.0|-0.008|0.076|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550)."||0.076|-0.008|0.1156
91719357|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.88||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.88|0.55|<0.05
91719358|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.8||||0.0046|TWO_SIDED|90.0|0.72|0.89||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.89|0.72|0.0046
91684971|NCT01696058|183260103|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|7.237|STANDARD_ERROR_OF_MEAN|2.145||0.0008|TWO_SIDED|95.0|3.028|11.446|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)."||11.446|3.028|0.0008
91684972|NCT01696058|183260104|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.568|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.8|-0.336|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.336|-0.800|<.0001
91684973|NCT01696058|183260105|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 1|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.0467|TWO_SIDED|95.0|-0.178|-0.001|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.001|-0.178|0.0467
91684974|NCT01696058|183260106|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.483|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.668|-0.298|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.298|-0.668|<.0001
91684975|NCT04746794|183260143|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
91684976|NCT04746794|183260144|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91684977|NCT00856375|183260152|OTHER|Hazard Ratio and 95% CI from univariate Cox regression model|Hazard Ratio (HR)|0.645|||=|0.07|TWO_SIDED|95.0|0.4|1.041|||Log Rank|||||1.041|0.4|= 0.07
91684978|NCT00856375|183260153|OTHER|Hazard ratio and 95% CI from univariate Cox regression model.|Hazard Ratio (HR)|0.91|||=|0.706|TWO_SIDED|95.0|0.557|1.486|||Log Rank|||||1.486|0.557|= 0.706
91684979|NCT00856375|183260154|OTHER|ORR 95% CI based on Exact (Clopper-Pearson) confidence limits. Odds ratio 95% CI based on asymptotic confidence limits.|Odds Ratio (OR)|2.054|||=|0.676|TWO_SIDED|95.0|0.355|11.9|||Fisher Exact|||||11.9|0.355|= 0.676
91684980|NCT00856375|183260155|SUPERIORITY||||||=|0.018|||||||Log Rank|||||||= 0.018
91684981|NCT04414345|183260158|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.797|1.188||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. CNM-Au8 slowed progression) was 0.59059. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by CNM-Au8 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||"The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality.~The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes."|1.188|0.797|
91684982|NCT04414345|183260160|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.766||0.657|TWO_SIDED|95.0|-4.25|2.68|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||2.68|-4.25|0.6570
91684983|NCT04414345|183260161|SUPERIORITY||Mean Difference (Net)|-3.1|STANDARD_ERROR_OF_MEAN|3.403||0.3621|TWO_SIDED|95.0|-9.78|3.58|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||3.58|-9.78|0.3621
91684984|NCT04414345|183260162|SUPERIORITY|||||||0.7398|||||||Log Rank|||||||0.7398
91684985|NCT00875797|183260179|NON_INFERIORITY_OR_EQUIVALENCE|t-test||||||0.05|TWO_SIDED|95.0||||p\<0.05|t-test, 2 sided|||||||0.05
91684986|NCT00875797|183260180|NON_INFERIORITY_OR_EQUIVALENCE|χ2 test|percentage of infection|20.0|STANDARD_DEVIATION|10.0||0.05|TWO_SIDED|95.0||||p\<0.05|Chi-squared|2 degrees of freedom||||||0.05
91684987|NCT00875797|183260181|SUPERIORITY_OR_OTHER||percentage of survivers|80.0|||<|0.05||95.0||||p\<0.05|Chi-squared, Corrected|2-degrees of freedom||Chi-square||||<0.05
91684988|NCT00000620|183260182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.12|TWO_SIDED|95.0|0.81|1.03||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.03|0.81|0.12
91684989|NCT00000620|183260183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.02|TWO_SIDED|95.0|1.03|1.38||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.38|1.03|0.02
91684990|NCT00000620|183260184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2|TWO_SIDED|95.0|0.73|1.06||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.||1.06|0.73|0.20
91684991|NCT00000620|183260185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.01|TWO_SIDED|95.0|0.39|0.89||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||0.89|0.39|0.01
91719359|NCT00042289|183331656|SUPERIORITY||Geometric mean ratio|0.66|||<|0.05|TWO_SIDED|90.0|0.52|0.85||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.85|0.52|<0.05
91684992|NCT00000620|183260186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.32|TWO_SIDED|95.0|0.79|1.08||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.||1.08|0.79|0.32
91684993|NCT00000620|183260187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3|TWO_SIDED|95.0|0.85|1.05||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||1.05|0.85|0.30
91684994|NCT05084924|183260188|SUPERIORITY|||||||0.049|||||||ANOVA|Main effect of stimulation: F(2,32) = 3.32||||||0.049
91684995|NCT05084924|183260189|SUPERIORITY|||||||0.004||||||Main effect of stimulation: F(2,32) = 6.67|ANOVA|||||||0.004
91684996|NCT03774407|183260190|OTHER|||||||0.002||||||This P value reported was for bladder urinary frequency change from baseline to 9 months|p value|||||||0.002
91684997|NCT00182325|183260193|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91684998|NCT00182325|183260194|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91684999|NCT00182325|183260195|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
91685000|NCT00182325|183260196|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91685001|NCT00182325|183260197|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
91685002|NCT00182325|183260198|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91685003|NCT00182325|183260199|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91685004|NCT00182325|183260200|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
91685005|NCT00182325|183260201|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
91719360|NCT00042289|183331656|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91685006|NCT00182325|183260202|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
91719361|NCT00042289|183331656|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719362|NCT00042289|183331656|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
91719363|NCT00042289|183331656|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
91685007|NCT03322930|183260213|OTHER||||||<|0.05||||||calculated from data|t-test, 2 sided||||mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient|||<0.05
91685008|NCT03344861|183260214|OTHER|No comparator arm.|Clopper-Pearson (binomial proportion)|0.05|||<|0.05|TWO_SIDED||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion|Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.||||<0.05
91685009|NCT03344861|183260239|OTHER||||||<|0.05|||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.||"All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as reasonable possibility on the CRF (Case Report Form)."||||<0.05
91685010|NCT02728843|183260257|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685011|NCT02728843|183260258|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685012|NCT02728843|183260259|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685013|NCT02728843|183260260|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685014|NCT02728843|183260261|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685015|NCT02728843|183260262|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685016|NCT02728843|183260263|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91685017|NCT03185013|183260268|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in percentage|11.4||||0.029|TWO_SIDED|95.0|-0.4|21.2|||Miettinen and Nurminen method|||||21.2|-0.4|0.029
91685018|NCT03185013|183260270|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|12.8|||||TWO_SIDED|95.0|-0.6|24.5||||||||24.5|-0.6|
91685019|NCT03185013|183260271|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|18.2|||||TWO_SIDED|95.0|5.1|29.4||||||||29.4|5.1|
91685020|NCT03185013|183260272|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|13.5|||||TWO_SIDED|95.0|1.7|23.5||||||||23.5|1.7|
91685021|NCT03185013|183260273|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|11.8|||||TWO_SIDED|95.0|1.5|20.3||||||||20.3|1.5|
91685022|NCT03185013|183260274|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|-1.7|||||TWO_SIDED|95.0|-11.5|10.3||||||||10.3|-11.5|
91685023|NCT03185013|183260275|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|10.8|||||TWO_SIDED|95.0|-0.5|20.1||||||||20.1|-0.5|
91685024|NCT03185013|183260276|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|224.0|||||TWO_SIDED|95.0|24.0|224.0||||||Week 15: HPV-16 E7||224.0|24.0|
91685025|NCT03185013|183260276|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 36: HPV-16 E7||0.0|0.0|
91685026|NCT03185013|183260276|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|2024.0|||||TWO_SIDED|95.0|2000.0|6050.0||||||Week 15: HPV-18 E7||6050.0|2000.0|
91685027|NCT03185013|183260276|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|224.0|||||TWO_SIDED|95.0|74.0|674.0||||||Week 36: HPV-18 E7||674.0|74.0|
91685028|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|11.67|||||TWO_SIDED|95.0|8.33|20.0||||||HPV-16 E6: Week 15||20.00|8.33|
91487372|NCT02642029|182847283|OTHER||beta coefficient for visual hallucinatio|-0.00039||||0.685|TWO_SIDED|95.0|-0.0023|0.00151||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, visual hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00151|-0.00230|0.685
91487373|NCT02642029|182847284|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.02||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.020
91487374|NCT02642029|182847284|OTHER||beta coefficient for paranoid ideation|0.0004||||0.597|TWO_SIDED|95.0|-0.00108|0.00188||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, paranoid ideation). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00188|-0.00108|0.597
91487375|NCT02642029|182847285|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.237||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.237
91685029|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
91685030|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.83|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-16 E7: Week 15||15.00|5.00|
91685031|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|7.5|||||TWO_SIDED|95.0|1.67|10.0||||||HPV-16 E7: Week 36||10.00|1.67|
91685032|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|50.83|||||TWO_SIDED|95.0|31.67|66.67||||||HPV-18 E6: Week 15||66.67|31.67|
91685033|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|38.33|||||TWO_SIDED|95.0|18.33|51.67||||||HPV-18 E6: Week 36||51.67|18.33|
91685034|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|14.17|||||TWO_SIDED|95.0|6.67|18.33||||||HPV-18 E7: Week 15||18.33|6.67|
91685035|NCT03185013|183260277|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.0|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-18 E7: Week 36||15.00|5.00|
91685036|NCT03185013|183260278|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.025|||||TWO_SIDED|95.0|0.002|0.046||||||Parameter: CD8+CD137+Perforin+||0.046|0.002|
91685037|NCT03185013|183260278|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.011|||||TWO_SIDED|95.0|0.0|0.014||||||Parameter: CD8+CD38+Perforin+||0.014|0.000|
91685038|NCT03185013|183260278|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.044|||||TWO_SIDED|95.0|0.017|0.058||||||Parameter: CD8+CD69+Perforin+||0.058|0.017|
91719364|NCT00042289|183331656|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91685039|NCT00197496|183260286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.3|||<|0.05|TWO_SIDED|95.0|-72.1|19.6|||Regression, Linear|||||19.6|-72.1|<0.05
91685040|NCT00197496|183260289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.4|TWO_SIDED|95.0|-3.6|9.2|||Regression, Linear|||||9.2|-3.6|0.40
91685041|NCT01175031|183260360|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||signed-rank tests|||||||0.003
91685042|NCT02056392|183260364|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
91685043|NCT02056392|183260364|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|6.1|||||TWO_SIDED|90.0|4.4|7.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||7.7|4.4|
91685044|NCT02056392|183260365|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|90.0|-2.0|1.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.3|-2.0|
91685045|NCT02056392|183260365|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.2|||||TWO_SIDED|90.0|7.6|10.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.8|7.6|
91719365|NCT00042289|183331656|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719366|NCT00042289|183331657|SUPERIORITY||Geometric mean ratio|0.97||||0.07|TWO_SIDED|90.0|0.83|1.13||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.13|0.83|0.07
91719367|NCT00042289|183331657|SUPERIORITY||Geometric mean ratio|0.77|||<|0.05|TWO_SIDED|90.0|0.61|0.96||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.96|0.61|<0.05
91719368|NCT00042289|183331657|SUPERIORITY||Geometric mean ratio|0.8|||<|0.05|TWO_SIDED|90.0|0.62|1.03||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.62|<0.05
91719369|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.81||||0.148|TWO_SIDED|90.0|0.64|1.01||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.01|0.64|0.148
91719370|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.62|<0.001
91719371|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.74||||0.0098|TWO_SIDED|90.0|0.61|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.61|0.0098
91719372|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.75||||0.0025|TWO_SIDED|90.0|0.64|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.88|0.64|0.0025
91719373|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.54|||<|0.0001|TWO_SIDED|90.0|0.46|0.64||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.64|0.46|<0.0001
91719374|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.56||||0.0024|TWO_SIDED|90.0|0.41|0.76||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.76|0.41|0.0024
91719375|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.795||||0.438|TWO_SIDED|90.0|0.499|1.269||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.269|0.499|0.438
91719376|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.531||||0.219|TWO_SIDED|90.0|0.186|1.512||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.512|0.186|0.219
91719377|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|1.05||||0.296|TWO_SIDED|90.0|0.94|1.18||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.18|0.94|0.296
91719378|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|1.26||||0.007|TWO_SIDED|90.0|1.01|1.56||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.56|1.01|0.007
91719379|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.83||||0.16|TWO_SIDED|90.0|0.56|1.22||2nd Trimester vs Postpartum|Wilcoxon signed rank test|||FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.||1.22|0.56|0.16
91719380|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.74||||0.03|TWO_SIDED|90.0|0.58|0.93|||Wilcoxson signed rank test|||FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.||0.93|0.58|0.03
91719381|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.86|||>|0.05|TWO_SIDED|90.0|0.68|1.08||3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)|Wilcoxon signed rank test|||This analysis was for ATV.||1.08|0.68|>0.05
91719382|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.89||||0.1636|TWO_SIDED|90.0|0.79|1.01||Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||||1.01|0.79|0.1636
91719383|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.69|||<|0.05|TWO_SIDED|90.0|0.53|0.91||3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||This analysis was for ATV.||0.91|0.53|<0.05
91719384|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|1.11||||0.16|TWO_SIDED|90.0|0.99|1.24||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)|Wilcoxon signed rank test|||||1.24|0.99|0.16
91719385|NCT00042289|183331658|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719386|NCT00042289|183331658|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719387|NCT00042289|183331658|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719388|NCT00042289|183331658|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719389|NCT00042289|183331658|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
91719390|NCT00042289|183331658|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
91719391|NCT00042289|183331658|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719392|NCT00042289|183331658|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719393|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|1.06||||0.67|TWO_SIDED|90.0|0.85|1.34||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 2 participants had Second Trimester data)|Wilcoxon signed-rank test|||||1.34|0.85|0.67
91719394|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.73||||0.08|TWO_SIDED|90.0|0.59|0.91||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.91|0.59|0.08
91719395|NCT00042289|183331658|SUPERIORITY||Geometric mean of ratio|0.63|||<|0.01|TWO_SIDED|90.0|0.55|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.72|0.55|<0.01
91719396|NCT00042289|183331659|SUPERIORITY||Geometric mean of ratio|0.57|||<|0.05|TWO_SIDED|90.0|0.48|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.68|0.48|<0.05
91719397|NCT00042289|183331659|SUPERIORITY||Geometric mean of ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.62|0.85||3rd Trimester vs.Postpartum|Wilcoxon signed rank test|||||0.85|0.62|<0.05
91719398|NCT00042289|183331659|SUPERIORITY|||||||0.09||||||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.09
91719399|NCT00042289|183331659|SUPERIORITY|||||||0.003||||||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.003
91719400|NCT00042289|183331659|SUPERIORITY||Geometric mean of ratio|1.34||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 5 participants had Second Trimester data)|Wilcoxon signed rank test|||||||0.036
91719401|NCT00042289|183331659|SUPERIORITY||Geometric mean of ratio|0.84|||>|0.05|TWO_SIDED|90.0|0.69|1.02||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.02|0.69|>0.05
91719402|NCT00042289|183331659|SUPERIORITY||Geometric mean of ratio|0.83|||>|0.05|TWO_SIDED|90.0|0.68|1.01||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.01|0.68|>0.05
91719403|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.61||||0.14|TWO_SIDED|90.0|0.34|1.09||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.09|0.34|0.14
91719404|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.64||||0.002|TWO_SIDED|90.0|0.5|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.81|0.50|0.002
91719405|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.77||||0.24|TWO_SIDED|90.0|0.49|1.23||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.23|0.49|0.24
91719406|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.84||||0.53|TWO_SIDED|90.0|0.6|1.17||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.17|0.60|0.53
91719407|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.58||||0.2|TWO_SIDED|90.0|0.3|1.11||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.11|0.30|0.2
91719408|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.95||||0.12|TWO_SIDED|90.0|0.58|1.55||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.55|0.58|0.12
91719409|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.92||||0.358|TWO_SIDED|90.0|0.71|1.2||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.2|0.71|0.358
91719410|NCT00042289|183331660|SUPERIORITY||Geometric mean of ratio|0.72||||0.0156|TWO_SIDED|90.0|0.55|0.93||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.93|0.55|0.0156
91719411|NCT00042289|183331661|SUPERIORITY||Geometric mean of ratio|0.7||||0.007|TWO_SIDED|90.0|0.58|0.85||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since no Second Trimester data was available)|Wilcoxon signed rank test|||||0.85|0.58|0.007
91719412|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|0.66||||0.109|TWO_SIDED|90.0|0.39|1.12||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.39|0.109
91719413|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.49|0.69||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.69|0.49|<0.001
91719414|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|0.48||||0.44|TWO_SIDED|90.0|0.14|1.65||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.65|0.14|0.44
91719415|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|0.56|||<|0.001|TWO_SIDED|90.0|0.43|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.43|<0.001
91526954|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.2915|TWO_SIDED|95.0|-0.9|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 3 SCCAI score||3.1|-0.9|0.2915
91719416|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|0.83||||0.43|TWO_SIDED|90.0|0.63|1.1||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.10|0.63|0.43
91719417|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|1.0||||0.31|TWO_SIDED|90.0|0.69|1.44||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.44|0.69|0.31
91719418|NCT00042289|183331662|SUPERIORITY||Geometric mean ratio|0.9||||0.49|TWO_SIDED|90.0|0.71|1.16||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.16|0.71|0.49
91719419|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|0.45|||<|0.05|TWO_SIDED|90.0|0.32|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.32|<0.05
91719420|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|0.72|||<|0.05|TWO_SIDED|90.0|0.58|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.58|<0.05
91719421|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|0.42||||0.02|TWO_SIDED|90.0|0.23|0.78||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.78|0.23|0.02
91719422|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|0.78||||0.3|TWO_SIDED|90.0|0.56|1.08||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.08|0.56|0.3
91719423|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|1.41||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.036
91719424|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|0.41|||<|0.05|TWO_SIDED|90.0|0.32|0.52||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.52|0.32|<0.05
91719425|NCT00042289|183331663|SUPERIORITY||Geometric mean ratio|0.48|||<|0.05|TWO_SIDED|90.0|0.41|0.57||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.57|0.41|<0.05
91719426|NCT00042289|183331664|SUPERIORITY||Geometric mean ratio|0.85||||0.1|TWO_SIDED|90.0|0.72|1.01||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||1.01|0.72|0.10
91719427|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.49||||0.0039|TWO_SIDED|90.0|0.35|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.35|0.0039
91719428|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.66||||0.0062|TWO_SIDED|90.0|0.52|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.52|0.0062
91719429|NCT00042289|183331665|SUPERIORITY||||||<|0.1||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
91719430|NCT00042289|183331665|SUPERIORITY||||||<|0.1||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
91719431|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.15|||<|0.1|TWO_SIDED|90.0|0.08|0.3||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.30|0.08|<0.10
91719432|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.21|||<|0.1|TWO_SIDED|90.0|0.12|0.36||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.36|0.12|<0.10
91719433|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.32|||<|0.1|TWO_SIDED|90.0|0.2|0.51||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.51|0.20|<0.10
91719434|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.32|||>|0.1|TWO_SIDED|90.0|0.11|0.94||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.94|0.11|>0.10
91719435|NCT00042289|183331665|OTHER||Geometric mean ratio|0.87||||0.079|TWO_SIDED|90.0|0.78|0.97||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.97|0.78|0.079
91719436|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.92||||0.01|TWO_SIDED|90.0|0.77|1.09||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.09|0.77|0.01
91685046|NCT02056392|183260366|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-0.7|2.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.5|-0.7|
91685047|NCT02056392|183260366|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.9|||||TWO_SIDED|90.0|8.3|11.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.5|8.3|
91685048|NCT02056392|183260367|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|90.0|-1.2|2.0|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.0|-1.2|
91685049|NCT02056392|183260367|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.1|||||TWO_SIDED|90.0|8.5|11.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.8|8.5|
91685050|NCT02056392|183260368|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
91685051|NCT02056392|183260368|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|11.9||||||90.0|10.3|13.6|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||13.6|10.3|
91685052|NCT02056392|183260369|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.5|||||TWO_SIDED|90.0|-3.1|0.2|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.2|-3.1|
91685053|NCT02056392|183260369|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.8|||||TWO_SIDED|90.0|9.2|12.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||12.5|9.2|
91685054|NCT02056392|183260370|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-3.4|-0.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.1|-3.4|
91685055|NCT02056392|183260370|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.8|||||TWO_SIDED|90.0|7.1|10.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.4|7.1|
91685056|NCT02056392|183260371|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-2.9|0.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.4|-2.9|
91685057|NCT02056392|183260371|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.9|||||TWO_SIDED|90.0|7.2|10.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.5|7.2|
91685058|NCT02056392|183260372|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-4.7|||||TWO_SIDED|90.0|-6.4|-3.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-3.1|-6.4|
91719437|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.37|0.72||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.72|0.37|<0.05
91719438|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.82||||0.0325|TWO_SIDED|90.0|0.71|0.96||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.96|0.71|0.0325
91719439|NCT00042289|183331665|SUPERIORITY||Geometric mean ratio|0.65|||<|0.05|TWO_SIDED|90.0|0.54|0.77||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.77|0.54|<0.05
91685059|NCT02056392|183260372|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|7.6|||||TWO_SIDED|90.0|6.0|9.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||9.3|6.0|
91685060|NCT02056392|183260373|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|90.0|-4.1|-0.9|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.9|-4.1|
91685061|NCT02056392|183260373|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|4.0|||||TWO_SIDED|90.0|2.4|5.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||5.7|2.4|
91685062|NCT00555360|183260374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.0||0.975|TWO_SIDED|95.0|-4.62|4.77|||Regression, Logistic|||||4.77|-4.62|.975
91685063|NCT00555360|183260375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.7||0.349|TWO_SIDED|95.0|-5.78|2.05|||Regression, Logistic|||||2.05|-5.78|.349
91685064|NCT00555360|183260376|SUPERIORITY_OR_OTHER||Difference in Percent|14.0|STANDARD_DEVIATION|6.0||0.007|TWO_SIDED|95.0|3.9|24.2|||Regression, Logistic|||||24.2|3.9|.007
91685065|NCT00658021|183260386|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.363||0.444|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.||0.45|-1.01|0.444
91685066|NCT00658021|183260388|SUPERIORITY|||||||0.562|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 7% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.562
91685067|NCT00658021|183260388|SUPERIORITY|||||||0.621|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \<= 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.621
91685068|NCT00658021|183260388|SUPERIORITY|||||||0.229|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.229
91685069|NCT00658021|183260389|SUPERIORITY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.327||0.005|TWO_SIDED|95.0|-1.58|-0.28|||Mixed Models Analysis|||"Treatment difference in body weight at Week 4:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||-0.28|-1.58|0.005
91685070|NCT00658021|183260389|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.669||0.314|TWO_SIDED|95.0|-2.0|0.65|||Mixed Models Analysis|||"Treatment difference in body weight at Week 12:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||0.65|-2.00|0.314
91685071|NCT00658021|183260389|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.94||0.692|TWO_SIDED|95.0|-2.24|1.5|||Mixed Models Analysis|||"Treatment difference in body weight at Week 20:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.50|-2.24|0.692
91685072|NCT00658021|183260389|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.065||0.679|TWO_SIDED|95.0|-2.56|1.68|||Mixed Models Analysis|||"Treatment difference in body weight at Week 28:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.68|-2.56|0.679
91685073|NCT00658021|183260390|SUPERIORITY||LS Mean Difference|-0.281|STANDARD_ERROR_OF_MEAN|0.68||0.679|TWO_SIDED|95.0|-1.614|1.052|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.052|-1.614|0.679
91719440|NCT00042289|183331665|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91685074|NCT00658021|183260391|SUPERIORITY||LS Mean Difference|0.189|STANDARD_ERROR_OF_MEAN|0.5151||0.714|TWO_SIDED|95.0|-0.821|1.199|||ANCOVA|||Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.199|-0.821|0.714
91685075|NCT00658021|183260391|SUPERIORITY||LS Mean Difference|0.513|STANDARD_ERROR_OF_MEAN|0.5245||0.329|TWO_SIDED|95.0|-0.516|1.541|||ANCOVA|||Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.541|-0.516|0.329
91719441|NCT00042289|183331665|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91526955|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.7251|TWO_SIDED|95.0|-2.4|1.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 3 SCCAI score||1.7|-2.4|0.7251
91685076|NCT00658021|183260391|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.4015||0.601|TWO_SIDED|95.0|-0.577|0.997|||ANCOVA|||Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||0.997|-0.577|0.601
91685077|NCT00658021|183260391|SUPERIORITY||LS Mean Difference|0.316|STANDARD_ERROR_OF_MEAN|0.4749||0.505|TWO_SIDED|95.0|-0.615|1.248|||ANCOVA|||Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.248|-0.615|0.505
91685078|NCT00658021|183260392|SUPERIORITY||LS Mean Difference|-10.82|STANDARD_ERROR_OF_MEAN|43.187||0.802|TWO_SIDED|95.0|-95.48|73.84|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.||73.84|-95.48|0.802
91685079|NCT00658021|183260393|SUPERIORITY||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|18.542||0.836|TWO_SIDED|95.0|-40.19|32.51|||ANCOVA|||Treatment difference for HOMA-B: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.||32.51|-40.19|0.836
91685080|NCT00658021|183260393|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|3.846||0.941|TWO_SIDED|95.0|-7.82|7.26|||ANCOVA|||Treatment difference for HOMA-S: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.||7.26|-7.82|0.941
91685081|NCT05819203|183260429|SUPERIORITY|||||||0.0013|||||||Wilcoxon (Mann-Whitney)|||Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||0.0013
91685082|NCT05819203|183260430|SUPERIORITY|||||||0.0209|||||||Cox survival regression and p Wald|||Comparison of the mean duration of common cold during the study between both groups.||||0.0209
91685083|NCT05819203|183260431|SUPERIORITY|||||||0.0399|||||||Cox survival regression and p Wald|||Comparison of the mean duration of impact of common cold on quality of life during the study between both groups.||||0.0399
91685084|NCT05819203|183260432|SUPERIORITY|||||||0.0015|||||||Poisson regression|||||||0.0015
91685085|NCT05819203|183260433|SUPERIORITY||||||>|0.05||||||not significant|Poisson regression|||||||>0.05
91685086|NCT05819203|183260434|SUPERIORITY|||||||0.0029|||||||Poisson regression|||||||0.0029
91685087|NCT05819203|183260435|SUPERIORITY|||||||0.0006|||||||Poisson regression|||||||0.0006
91685088|NCT05819203|183260436|SUPERIORITY|||||||0.0513|||||||Poisson regression|||||||0.0513
91685089|NCT05819203|183260437|SUPERIORITY|||||||0.0789|||||||Poisson regression|||||||0.0789
91685090|NCT05819203|183260438|SUPERIORITY||||||<|0.0001|||||||Poisson regression|||||||<0.0001
91685091|NCT05819203|183260439|SUPERIORITY|Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||||0.0034|||||||t-test, 2 sided|||||||0.0034
91685092|NCT02952898|183260446|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
91685093|NCT02952898|183260446|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
91685094|NCT02968849|183260490|OTHER||Hazard Ratio (HR)|1.02||||0.84|TWO_SIDED|95.0|0.81|1.3|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.30|0.81|0.84
91719442|NCT00042289|183331665|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
91685095|NCT02968849|183260490|OTHER||Hazard Ratio (HR)|1.03||||0.83|TWO_SIDED|95.0|0.81|1.31|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.31|0.81|0.83
91685096|NCT02968849|183260501|OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.85|1.28|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.28|0.85|0.66
91685097|NCT02968849|183260501|OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.81|1.23|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.23|0.81|0.98
91685098|NCT02968849|183260503|OTHER||Hazard Ratio (HR)|1.15||||0.39|TWO_SIDED|95.0|0.84|1.58|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.58|0.84|0.39
91685099|NCT02968849|183260503|OTHER||Hazard Ratio (HR)|1.12||||0.5|TWO_SIDED|95.0|0.81|1.54|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.54|0.81|0.50
91719443|NCT00042289|183331665|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
91719444|NCT00042289|183331665|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719445|NCT00042289|183331665|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
91719446|NCT00042289|183331666|SUPERIORITY||Geometric mean ratio|0.88|||<|0.05|TWO_SIDED|90.0|0.73|1.06||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.06|0.73|<0.05
91719447|NCT00042289|183331666|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.9||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.90|0.55|<0.05
91719448|NCT00042289|183331666|SUPERIORITY||Geometric mean ratio|0.84|||<|0.05|TWO_SIDED|90.0|0.57|1.23||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.23|0.57|<0.05
91719449|NCT00042289|183331670|SUPERIORITY||Geometric mean of ratio|1.24||||0.114|TWO_SIDED|90.0|0.97|1.59||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical analysis is for LPV PK.||1.59|0.97|0.114
91719450|NCT00042289|183331671|SUPERIORITY||Geometric mean of ratio|1.1||||0.367|TWO_SIDED|90.0|0.84|1.44||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical test is for ATV PK.||1.44|0.84|0.367
91719451|NCT00042289|183331671|SUPERIORITY||Geometric mean of ratio|1.02||||0.561|TWO_SIDED|90.0|0.92|1.13|||Wilcoxon signed rank test|Before ENG initiation vs. after ENG initiation||The statistical test is for EFV PK.||1.13|0.92|0.561
91719452|NCT00498550|183331696|SUPERIORITY||difference in treatment means|-4.54|STANDARD_ERROR_OF_MEAN|2.57||0.088|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.088
91719453|NCT04460885|183331712|NON_INFERIORITY|The response and change from baseline in response after 52 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and region as fixed factors, and baseline response as covariate.|Treatment difference|-0.19|||<|0.0001|TWO_SIDED|95.0|-0.36|-0.03|||ANCOVA|||||-0.03|-0.36|<0.0001
91719454|NCT05352815|183331737|SUPERIORITY|Change in HbA1c from baseline to week 52 is analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Missing HbA1c values at week 52 are imputed by using multiple imputation. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.57|||ANCOVA|||||-0.57|-0.76|<0.0001
91719455|NCT00534469|183331777|OTHER|Two-sided test.||||||0.43||||||Log-rank test (Mantel-Haenszel test). This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Log Rank|||Null hypothesis: All four groups are drawn from the same distribution. Alternative hypothesis: At least one of the groups has measurably different survival from the others.||||0.43
91719456|NCT02592824|183331778|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||Two-sided Student's t-test used for sample size estimation which was based on data from the first GLUTAMICS trial.||||0.086
91719457|NCT02592824|183331779|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91719458|NCT02592824|183331780|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91719459|NCT02592824|183331785|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91719460|NCT01704261|183331786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.38|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-0.38|-0.85|<0.001
91719461|NCT01704261|183331787|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|9.8|||||TWO_SIDED|95.0|-1.4|20.8||||||||20.8|-1.4|
91719462|NCT01704261|183331788|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|0.0|||||TWO_SIDED|95.0|-4.3|4.3||||||||4.3|-4.3|
91719463|NCT01704261|183331789|SUPERIORITY_OR_OTHER||Difference of the least squares means|-16.6|||<|0.001|TWO_SIDED|95.0|-25.5|-7.8|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-7.8|-25.5|<0.001
91719464|NCT01704261|183331790|SUPERIORITY_OR_OTHER||Between-group Rate Difference|19.3|||<|0.001|TWO_SIDED|95.0|11.7|27.6|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||27.6|11.7|<0.001
91719465|NCT01704261|183331790|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|8.0||||0.005|TWO_SIDED|95.0|2.7|14.5|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||14.5|2.7|0.005
91719466|NCT02855268|183331821|SUPERIORITY||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.27||0.9472|TWO_SIDED|95.0|-6.92|6.48||Threshold of significance was 1-sided \<0.025.|Linear mixed effect model|||Annualized rate of change in eGFR during the placebo-controlled treatment period was compared between lademirsen and placebo using a random coefficient linear mixed effect model which included time as a continuous variable.||6.48|-6.92|0.9472
91719467|NCT02326064|183331868|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
91719468|NCT02326064|183331869|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
91719469|NCT00111761|183331870|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|9.8|46.7||||||||46.7|9.8|
91719470|NCT00111761|183331871|SUPERIORITY_OR_OTHER||Percentage of participants|58.0||||||95.0|34.0|80.0||||||||80|34|
91719471|NCT00111761|183331872|SUPERIORITY_OR_OTHER||Percentage|33.3||||||95.0|15.6|55.3||||||||55.3|15.6|
91719472|NCT00111761|183331877|SUPERIORITY_OR_OTHER||Percentage of participants|47.4||||||95.0|24.4|71.1||||||||71.1|24.4|
91719473|NCT00914069|183331889|SUPERIORITY_OR_OTHER|||||||0.05||||||Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.|Fisher Exact|||||||0.05
91719474|NCT00914069|183331892|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
91719475|NCT00071981|183331896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare CTL response rate among four arms. The null hypothesis is that CTL response is same in all four arms. Alternative hypothesis is that CTL response rate is different in at least one arm compared to other arms.||||<0.001
91719476|NCT00071981|183331897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to 6MHP among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
91719477|NCT00071981|183331898|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to tetanus peptide among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
91685100|NCT02968849|183260514|OTHER||Hazard Ratio (HR)|1.03||||0.82|TWO_SIDED|95.0|0.8|1.33|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.33|0.80|0.82
91685101|NCT02968849|183260515|OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.98|0.50|0.98
91685102|NCT02968849|183260516|OTHER||Hazard Ratio (HR)|1.08||||0.6|TWO_SIDED|95.0|0.8|1.47|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.47|0.80|0.60
91685103|NCT02968849|183260517|OTHER||Hazard Ratio (HR)|0.92||||0.71|TWO_SIDED|95.0|0.58|1.46|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.46|0.58|0.71
91685104|NCT02203331|183260522|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.1483|STANDARD_ERROR_OF_MEAN|0.2925||0.3875|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3875
91685105|NCT02203331|183260522|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.2484|STANDARD_ERROR_OF_MEAN|0.2975||0.2676|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.2676
91685106|NCT02203331|183260522|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.1995|STANDARD_ERROR_OF_MEAN|0.2922||0.3211|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3211
91685107|NCT02203331|183260522|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3467|STANDARD_ERROR_OF_MEAN|0.2994||0.1721|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1721
91685108|NCT02203331|183260523|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.2736|STANDARD_ERROR_OF_MEAN|0.2878||0.231|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.231
91685109|NCT02203331|183260523|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.3234|STANDARD_ERROR_OF_MEAN|0.2927||0.1865|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1865
91685110|NCT02203331|183260523|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.3081|STANDARD_ERROR_OF_MEAN|0.2875||0.1955|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1955
91685111|NCT02203331|183260523|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3781|STANDARD_ERROR_OF_MEAN|0.2944||0.1416|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1416
91685112|NCT02203331|183260524|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.0081|STANDARD_ERROR_OF_MEAN|0.2832||0.5794|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5794
91685113|NCT02203331|183260524|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.1148|STANDARD_ERROR_OF_MEAN|0.288||0.4301|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.4301
91685114|NCT02203331|183260524|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.0401|STANDARD_ERROR_OF_MEAN|0.2829||0.5337|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5337
91685115|NCT02203331|183260524|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.1835|STANDARD_ERROR_OF_MEAN|0.2899||0.3396|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3396
91685116|NCT05833139|183260567|OTHER||Geometric mean ratio (T/R) [%]|141.2|||||TWO_SIDED|90.0|126.3|157.7|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 18.0|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-∞ was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||157.7|126.3|
91685117|NCT05833139|183260568|OTHER||Geometric mean ratio (T/R) [%]|126.9|||||TWO_SIDED|90.0|106.6|151.0|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 28.7|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. Cmax was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||151.0|106.6|
91685118|NCT05833139|183260569|OTHER||Geometric mean ratio (T/R) [%]|142.8|||||TWO_SIDED|90.0|126.0|161.9|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 20.4|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-tz was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||161.9|126.0|
91685119|NCT01277601|183260584|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||< 0.001
91685120|NCT01277601|183260584|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||0.002
91685121|NCT02260570|183260621|SUPERIORITY||F value|24.1|||<|0.0001|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,1,60) = 24.1, p \< 0.0001, adjusted r\^2 = 0.275||||||<0.0001
91685122|NCT02260570|183260622|SUPERIORITY||F value|6.23||||0.0184|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,30) = 6.23, p = 0.0184, adjusted r\^2 = 0.144||||||0.0184
91685123|NCT04034927|183260625|SUPERIORITY||Odds Ratio (OR)|0.707|||||TWO_SIDED|95.0|0.241|2.068|||||The numerator is the experimental arm (odds of response) and the denominator is the control arm (odds of response).|Odds ratio for experimental arm (O + T) response compared to control arm (O) response.||2.068|0.241|
91487376|NCT02642029|182847285|OTHER||beta coefficient for ideas/del of refere|-0.00142||||0.178|TWO_SIDED|95.0|-0.0035|0.00065||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, ideas/delusions of reference). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00065|-0.00350|0.178
91487377|NCT02642029|182847286|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.33||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.330
91685124|NCT03956355|183260628|SUPERIORITY||Risk Ratio (RR)|5.78|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91685125|NCT03956355|183260629|SUPERIORITY||Risk Ratio (RR)|2.76|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91685126|NCT03956355|183260630|SUPERIORITY||Risk Ratio (RR)|2.68||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
91685127|NCT03956355|183260631|SUPERIORITY||Least squares mean difference|-3.28|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91685128|NCT03956355|183260632|SUPERIORITY||Risk Ratio (RR)|8.54||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0005
91685129|NCT00094861|183260633|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.8553||||0.355||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 2 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3550
91685130|NCT00094861|183260634|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9936||||0.3189||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3189
91685131|NCT00094861|183260635|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.437||||0.5086||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade 5 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.5086
91685132|NCT00094861|183260636|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.46||||0.4976||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 3 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.4976
91685133|NCT00094861|183260637|SUPERIORITY_OR_OTHER||Chi-Square Statistic|-2.5325||||0.1115||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants who never received radiotherapy were assumed to have unplanned breaks.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1115
91685134|NCT00094861|183260638|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.4812||||0.0621|TWO_SIDED|||||Generalized Cochran-Mantel-Haenszel (CMH) test for mean score difference using modified ridit score. Participants without any ECOG assessment post baseline were assumed to have ECOG status of 5 in the CMH test.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.0621
91685135|NCT00094861|183260639|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0294||||0.8639||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.8639
91526956|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4556|TWO_SIDED|95.0|-1.3|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 3 SCCAI score||2.9|-1.3|0.4556
91685136|NCT00094861|183260640|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.1414||||0.1996||||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1996
91685137|NCT00264550|183260641|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.||||<0.001
91685138|NCT00264550|183260641|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||0.001
91685139|NCT00264550|183260641|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||<0.001
91685140|NCT00264550|183260641|SUPERIORITY_OR_OTHER|||||||0.059||||||This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.|Chi-squared|||Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I \& II provides \>85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.||||0.059
91685141|NCT00264550|183260642|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91685142|NCT00264550|183260642|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
91685143|NCT00264550|183260642|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91685144|NCT00264550|183260642|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
91526957|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.662|TWO_SIDED|95.0|-2.3|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 3 SCCAI score||1.4|-2.3|0.6620
91685145|NCT00264550|183260643|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.||||<0.001
91685146|NCT00264550|183260643|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.||||<0.001
91685147|NCT00264550|183260643|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.||||<0.001
91685148|NCT00264550|183260643|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.||||0.240
91685149|NCT00264550|183260644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91685150|NCT00264550|183260644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91685151|NCT00264550|183260644|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91685152|NCT00264550|183260644|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Chi-squared|||||||0.187
91685153|NCT00264550|183260645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden noramal|||||||<0.001
91685154|NCT00264550|183260645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
91685155|NCT00264550|183260645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
91685156|NCT00264550|183260645|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||ANOVA on van der Waerden normal scores|||||||0.097
91685157|NCT00264550|183260646|SUPERIORITY_OR_OTHER|||||||0.551|||||||ANOVA on van der Waerden normal|||||||0.551
91685158|NCT00264550|183260646|SUPERIORITY_OR_OTHER|||||||0.953|||||||ANOVA on van der Waerden normal scores|||||||0.953
91685159|NCT00264550|183260646|SUPERIORITY_OR_OTHER|||||||0.293|||||||ANOVA on van der waerden normal scores|||||||0.293
91685160|NCT00264550|183260646|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANOVA on van der Waerden normal scores|||||||0.361
91685161|NCT02129608|183260647|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
91685162|NCT02129608|183260647|SUPERIORITY_OR_OTHER|||||||0.436|||||||t-test, 2 sided|||||||0.436
91685163|NCT02129608|183260648|SUPERIORITY_OR_OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.070
91685164|NCT02129608|183260648|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.950
91685165|NCT00451204|183260652|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077|TWO_SIDED|95.0|0.37|1.05|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 mo, time since dx, previous glatiramer acetate tx, and previous interferon beta tx.||||1.05|0.37|0.077
91685166|NCT00451204|183260653|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.098|TWO_SIDED|95.0|0.39|1.08|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.08|0.39|0.098
91685167|NCT00451204|183260654|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.096|TWO_SIDED|95.0|0.36|1.09|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.09|0.36|0.096
91685168|NCT00451204|183260655|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.179|TWO_SIDED|95.0|0.42|1.17|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.17|0.42|0.179
91685169|NCT00451204|183260656|SUPERIORITY_OR_OTHER||Rate ratio|0.49||||0.016|TWO_SIDED|95.0|0.28|0.88|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.88|0.28|0.016
91685170|NCT00451204|183260657|SUPERIORITY_OR_OTHER||Rate ratio|0.52||||0.012|TWO_SIDED|95.0|0.31|0.86|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.86|0.31|0.012
91685171|NCT03578549|183260664|OTHER||Correlation Coefficient|0.01||||0.92|TWO_SIDED||||||ANOVA|||||||0.92
91685172|NCT00741286|183260678|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||A linear mixed model for a repeated measures covariance pattern model with unstructured covariances within subjects was used. Two fixed effects were included: 1 between-subjects treatment effect (group: cilostazol, control) and 1 within-subject time effect (time: baseline, 14 days, 90 days). A possible difference in treatment across 14- and 90-day follow-up was analyzed by time x treatment interactions.||||<0.05
91685173|NCT00741286|183260678|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||To determine between-group differences of changes in the PIs at 14 and 90 days from the baseline study.||||<0.05
91685174|NCT00741286|183260679|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91685175|NCT02597127|183260680|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
91685176|NCT02597127|183260680|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
91685177|NCT02597127|183260680|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 500 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
91685178|NCT02597127|183260680|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 100 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
91685179|NCT02597127|183260680|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
91685180|NCT02597127|183260680|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
91685181|NCT01256944|183260707|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685182|NCT01256944|183260708|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91719478|NCT00071981|183331899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741|TWO_SIDED|95.0|||||Fisher Exact|||Compare objective response rate among four arms. The null hypothesis is that objective response rate is same in all four arms. Alternative hypothesis is that objective response rate is different in at least one arm compared to other arms.||||0.741
91685183|NCT01256944|183260709|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685184|NCT01256944|183260711|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685185|NCT01256944|183260712|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685186|NCT01256944|183260713|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685187|NCT01256944|183260714|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685188|NCT01256944|183260716|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685189|NCT01256944|183260717|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91685190|NCT01778634|183260801|SUPERIORITY||Odds Ratio (OR)|7.51|||<|0.0001|TWO_SIDED|95.0|2.53|22.27|||Cochran-Mantel-Haenszel|||||22.27|2.53|<0.0001
91685191|NCT01778634|183260802|SUPERIORITY||Risk Difference (RD)|0.11||||0.28|TWO_SIDED|95.0|-0.08|0.29|||Generalized Estimating Equations||Generalized Estimating Equations with an identity link|||0.29|-0.08|0.28
91685192|NCT01778634|183260803|SUPERIORITY|P values are based on GEE to account for twins||||||0.11|||||||GEE|||||||0.11
91685193|NCT01778634|183260804|SUPERIORITY|P values are based on GEE to account for twins. The counts provided refer to to the numbers actually observed. The analysis to determine the p value accounted for the missing 11 patients using multiple imputation.||||||0.62|||||||GEE with multiple imputation|||||||0.62
91685194|NCT01778634|183260805|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91685195|NCT01778634|183260806|SUPERIORITY|||||||0.88||||||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon (Mann-Whitney)|||||||0.88
91685196|NCT01778634|183260807|SUPERIORITY||Median Difference (Final Values)|5.0||||0.94|TWO_SIDED|95.0|-15.0|26.0||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon test after multiple outputation||Bootstrap|||26|-15|0.94
91685197|NCT01778634|183260808|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91685198|NCT01778634|183260809|SUPERIORITY||Odds Ratio (OR)|1.07||||0.88|TWO_SIDED|95.0|0.44|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.44|0.88
91526958|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2844|TWO_SIDED|95.0|-1.1|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 4 SCCAI score||3.5|-1.1|0.2844
91685199|NCT01778634|183260810|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
91685200|NCT01778634|183260812|SUPERIORITY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
91685201|NCT01778634|183260813|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91685202|NCT01778634|183260814|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
91685203|NCT01778634|183260815|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
91685204|NCT01778634|183260816|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91685205|NCT01778634|183260817|SUPERIORITY|||||||0.33|||||||Generalized Estimating Equations|||||||0.33
91685206|NCT01778634|183260818|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91685207|NCT02661217|183260819|SUPERIORITY||Risk Ratio (RR)|0.896||||0.099|TWO_SIDED|95.0|0.786|1.021|||Cochran-Mantel-Haenszel|||||1.021|0.786|0.099
91719479|NCT00071981|183331900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532|TWO_SIDED|95.0|||||Log Rank|||Compare overall survival curves among four arms.||||0.532
91526959|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2799|TWO_SIDED|95.0|-1.0|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 4 SCCAI score||3.5|-1.0|0.2799
91685208|NCT02661217|183260820|SUPERIORITY||Risk Ratio (RR)|0.906||||0.034|TWO_SIDED|95.0|0.827|0.993|||Cochran-Mantel-Haenszel|||||0.993|0.827|0.034
91685209|NCT02661217|183260821|SUPERIORITY||Risk Ratio (RR)|0.96||||0.089|TWO_SIDED|95.0|0.916|1.006|||Cochran-Mantel-Haenszel|||||1.006|0.916|0.089
91685210|NCT00687830|183260830|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91685211|NCT00687830|183260831|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
91685212|NCT02892149|183260832|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.23|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.23|
91719480|NCT00909870|183331922|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.103|TWO_SIDED|95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Chi-squared|Unadjusted||"H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.~HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.~The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%."||||0.1030
91685213|NCT02892149|183260833|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.96||||0.4745|TWO_SIDED|95.0|0.828|1.117|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.117|0.828|0.4745
91685214|NCT02892149|183260833|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
91685215|NCT02892149|183260834|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.25|-0.12||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.12|-0.25|
91685216|NCT02892149|183260835|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.3718|TWO_SIDED|95.0|0.832|1.097|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.097|0.832|0.3718
91685217|NCT02892149|183260835|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
91685218|NCT02892149|183260836|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.94||||0.3875|TWO_SIDED|95.0|0.777|1.131|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.131|0.777|0.3875
91685219|NCT02892149|183260836|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
91685220|NCT02892149|183260837|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.6281|TWO_SIDED|95.0|0.761|1.203|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.203|0.761|0.6281
91719481|NCT00909870|183331923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.0||||0.4046||95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Log Rank|||||||0.4046
91719482|NCT00909870|183331924|SUPERIORITY_OR_OTHER||Difference in proportions|10.0||||0.0239||95.0||||Unadjusted|Chi-squared|Unadjusted||Pre-specified subgroup analysis of the primary endpoint||||0.0239
91685221|NCT02892149|183260837|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
91685222|NCT02892149|183260838|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.5811|TWO_SIDED|95.0|0.816|1.136|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.136|0.816|0.5811
91685223|NCT02892149|183260838|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
91685224|NCT00101283|183260890|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|18.8|||||TWO_SIDED|90.0|5.4|41.7|||||Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||41.7|5.4|
91685225|NCT00101283|183260890|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|0.0|||||TWO_SIDED|90.0|0.0|20.6|||||Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||20.6|0.0|
91685226|NCT02054338|183260899|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.54|TWO_SIDED|95.0|0.91|1.2|||Log Rank|||Kaplan-Meier curves and life tables by treatment arm to describe time-dependent parameters. Stratified Cox proportional model was used to compare the 2 treatment arms. A stratified Cox proportional hazards model and logistic regression were applied to the progression-free survival and to the tumour response, respectively.||1.20|0.91|0.54
91685227|NCT02054338|183260900|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.87|1.19|||Log Rank|||||1.19|0.87|0.86
91685228|NCT02054338|183260901|SUPERIORITY||Hazard Ratio (HR)|11.3||||0.1|TWO_SIDED|95.0|8.7|14.4|||Log Rank|||||14.4|8.7|0.10
91685229|NCT01758588|183260949|OTHER||||||||||||||||||A statistical comparison and analysis of the clinical improvement (CI) proportions cannot be made because the sample size (n=5 in treatment arm, n=3 in observation arm) is too small|||
91685230|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|-2.26|||||TWO_SIDED|95.0|-8.08|2.33||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.33|-8.08|
91685231|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|-0.49|||||TWO_SIDED|95.0|-9.93|8.65||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||8.65|-9.93|
91685232|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|-2.27|||||TWO_SIDED|95.0|-8.07|2.26||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.26|-8.07|
91685233|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|0.68||||||95.0|-4.96|6.16||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.16|-4.96|
91685234|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|-2.25||||||95.0|-8.18|2.36||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.36|-8.18|
91719483|NCT03699748|183331925|OTHER||Mean Difference (Net)|10.92|||<|0.001|TWO_SIDED|95.0|7.27|14.58|||Type III F test|||||14.58|7.27|<0.001
91685235|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-4.84|6.32||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.32|-4.84|
91685236|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|-0.69||||||95.0|-7.75|5.86||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.86|-7.75|
91685237|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|72.87||||||95.0|63.32|81.07||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||81.07|63.32|
91685238|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|84.92||||||95.0|76.73|91.05||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||91.05|76.73|
91685239|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|57.94||||||95.0|48.01|67.42||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||67.42|48.01|
91685240|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|62.81||||||95.0|52.33|72.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||72.20|52.33|
91685241|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|92.27||||||95.0|85.26|96.54||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||96.54|85.26|
91685242|NCT00205803|183260955|SUPERIORITY_OR_OTHER||Difference|5.61||||||95.0|1.23|11.86||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||11.86|1.23|
91685243|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|-1.5||||||95.0|-7.9|3.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.6|-7.9|
91685244|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
91685245|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|-1.3||||||95.0|-6.9|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-6.9|
91685246|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
91685247|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.7|3.9||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.9|-4.7|
91685248|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
91685249|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-2.6|7.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.7|-2.6|
91685250|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|97.8||||||95.0|92.3|99.7||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||99.7|92.3|
91685251|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|83.6||||||95.0|73.2|90.8||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||90.8|73.2|
91685252|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|29.5||||||95.0|19.7|40.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||40.9|19.7|
91685253|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|12.0||||||95.0|5.9|20.4||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||20.4|5.9|
91685254|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|94.1||||||95.0|86.8|98.1||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||98.1|86.8|
91685255|NCT00205803|183260956|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
91685256|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|0.76||||||95.0|0.59|0.96||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.59|
91685257|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.62|1.48||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.48|0.62|
91685258|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Difference|0.85||||||95.0|0.69|1.05||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.05|0.69|
91685259|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.6|1.11||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.11|0.60|
91685260|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|0.62||||||95.0|0.49|0.79||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.79|0.49|
91685261|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.67|1.09||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.09|0.67|
91685262|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|0.77||||||95.0|0.59|1.0||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.59|
91685263|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|39.78||||||95.0|27.47|57.63||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||57.63|27.47|
91685264|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|15.56||||||95.0|11.63|20.81||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||20.81|11.63|
91685265|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|8.67||||||95.0|6.65|11.29||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||11.29|6.65|
91685266|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|9.6||||||95.0|7.07|13.04||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||13.04|7.07|
91685267|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|26.78||||||95.0|20.97|34.22||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||34.22|20.97|
91685268|NCT00205803|183260957|SUPERIORITY_OR_OTHER||Ratio|1.71||||||95.0|1.36|2.16||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||2.16|1.36|
91685269|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|3.08||||||95.0|-7.22|13.73||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||13.73|-7.22|
91685270|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|7.02||||||95.0|-7.28|21.14||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||21.14|-7.28|
91685271|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
91685272|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
91685273|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-5.97|5.68||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||5.68|-5.97|
91685274|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.24||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.24|-8.80|
91685275|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.21||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.21|-8.80|
91685276|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated||7.73|-9.38|
91685277|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|-1.74||||||95.0|-11.0|6.99||||||For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated||6.99|-11.00|
91685278|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|-6.36||||||95.0|-17.03|3.16||||||For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated||3.16|-17.03|
91719484|NCT03699748|183331928|OTHER||Effect Estimate for 4 Months|12.88|||||TWO_SIDED||||||||12.88 (9.49 - 16.28)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person. The effect estimate column shows the difference between change in the intervention group from baseline and the change in the control group from baseline.|||
91685279|NCT00205803|183260959|SUPERIORITY_OR_OTHER||Difference|1.33||||||95.0|-6.79|9.68||||||For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated||9.68|-6.79|
91685280|NCT00205803|183260960|SUPERIORITY_OR_OTHER||Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.14||||||||2.14|0.69|
91685281|NCT00205803|183260961|SUPERIORITY_OR_OTHER||Ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48||||||||1.48|0.63|
91685282|NCT00205803|183260962|SUPERIORITY_OR_OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.57|1.21||||||||1.21|0.57|
91685283|NCT00205803|183260963|SUPERIORITY_OR_OTHER||Ratio|1.01|||||TWO_SIDED|95.0|0.66|1.53||||||Polio Type 1||1.53|0.66|
91685284|NCT00205803|183260963|SUPERIORITY_OR_OTHER||Ratio|0.91|||||TWO_SIDED|95.0|0.56|1.49||||||Polio Type 2||1.49|0.56|
91685285|NCT00205803|183260963|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|95.0|0.69|1.84||||||Polio Type 3||1.84|0.69|
91685286|NCT00205803|183260964|SUPERIORITY_OR_OTHER||Ratio|0.92|||||TWO_SIDED|95.0|0.74|1.15||||||Pertussis - FHA||1.15|0.74|
91685287|NCT00205803|183260964|SUPERIORITY_OR_OTHER||Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25||||||Pertussis - PT||1.25|0.83|
91685288|NCT00205803|183260964|SUPERIORITY_OR_OTHER||Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44||||||Pertussis - Pertactin||1.44|0.76|
91685289|NCT03104400|183260990|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|34.5|||<|0.0001|TWO_SIDED|95.0|28.2|40.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||40.7|28.2|<0.0001
91685290|NCT03104400|183260990|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|42.3|||<|0.0001|TWO_SIDED|95.0|36.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|36.3|<0.0001
91685291|NCT03104400|183260991|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.28|||<|0.0001|TWO_SIDED|95.0|-0.35|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.35|<0.0001
91685292|NCT03104400|183260991|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.27|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.27|-0.40|<0.0001
91685293|NCT03104400|183260992|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.1|||<|0.0001|TWO_SIDED|95.0|24.7|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||37.5|24.7|<0.0001
91685294|NCT03104400|183260992|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|43.1|||<|0.0001|TWO_SIDED|95.0|36.7|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|36.7|<0.0001
91685295|NCT03104400|183260993|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.3|||<|0.0001|TWO_SIDED|95.0|32.8|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.8|32.8|<0.0001
91685296|NCT03104400|183260993|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.1|||<|0.0001|TWO_SIDED|95.0|32.5|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|32.5|<0.0001
91685297|NCT03104400|183260994|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.29||||0.0002|TWO_SIDED|95.0|-0.44|-0.14|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.14|-0.44|0.0002
91719485|NCT03699748|183331929|OTHER||Effect Estimate for 12 Months|20.65|||||TWO_SIDED||||||||20.65 (6.97 - 24.32)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person.|||
91719486|NCT03699748|183331930|OTHER||Median Difference (Net)|11.05||||0.001|TWO_SIDED|95.0|7.09|15.0|||Type III F-test|||||15.00|7.09|0.001
91719487|NCT03699748|183331932|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED||||||||0.91 (0.40-2.09)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
91719488|NCT03699748|183331933|OTHER||Odds Ratio (OR)|0.27|||||TWO_SIDED||||||||0.27 (0.03 - 2.85)||Odds Ratios for any ED Use were estimated using logistic regression models.|||
91719489|NCT03699748|183331934|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.18-0.76)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
91719490|NCT03699748|183331935|OTHER||Odds Ratio (OR)|0.42|||||TWO_SIDED||||||||0.42 (0.22-0.79)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
91719491|NCT03699748|183331936|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.08-1.75)||Odds Ratios for Hospitalization Use were estimated using logistic regression models.|||
91719492|NCT03699748|183331937|OTHER||Odds Ratio, log|5.86|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
91719493|NCT03699748|183331938|OTHER||Odds Ratio (OR)|4.09|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
91526960|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7655|TWO_SIDED|95.0|-1.9|2.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 4 SCCAI score||2.6|-1.9|0.7655
91719494|NCT03699748|183331939|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months post-enrollment with logistic regression.|||
91719495|NCT03699748|183331940|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||
91719496|NCT03699748|183331941|OTHER||Odds Ratio, log|8.56|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
91719497|NCT03699748|183331942|OTHER||Odds Ratio, log|19.55|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||||
91719498|NCT03699748|183331943|OTHER||Effect Estimate|0.65|||||TWO_SIDED||||||||0.65 (0.44-0.98)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data after adjustment for length of follow-up.|||
91719499|NCT03699748|183331944|OTHER||Effect Estimate|0.57|||||TWO_SIDED||||||||0.57 (0.28 - 1.18)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data.|||
91719500|NCT03699748|183331945|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
91719501|NCT03699748|183331946|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
91719502|NCT03699748|183331947|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Palliative Care were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
91719503|NCT03699748|183331948|OTHER||Odds Ratio (OR)|4.33|||||TWO_SIDED||||||||4.33 (0.89-21.08)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
91719504|NCT03699748|183331949|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED||||||||2.76 (1.01-7.55)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments at 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
91719505|NCT03699748|183331950|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Hospice Receipt were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
91719506|NCT03818854|183331954|SUPERIORITY|Using the change in oxygenation index over 36 hours from the baseline as the primary outcome with measurements taken at 6 time points, the trial was estimated to have 80% power to detect an effect size difference of 0.43 between the trial arms.||||||0.34||||||The mixed model included the following variables: treatment arm, 6 time-points, sites, pre-defined randomization stratifications and the baseline characteristics with bivariate analyses P \< 0.20.|Mixed Models Analysis|||||||0.34
91719507|NCT03818854|183331955|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||The analysis is for the change of LIS from the baseline to day 1.||||0.92
91719508|NCT03818854|183331955|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||The analysis is for the change of LIS from the baseline to day 2.||||0.37
91719509|NCT03818854|183331955|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||The analysis is for the change of LIS from the baseline to day 3.||||0.54
91719510|NCT03818854|183331955|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||The analysis is for the change of LIS from the baseline to day 7.||||0.19
91719511|NCT03818854|183331957|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||The analysis is for the change in RALE scores from the baseline to day 1.||||0.35
91719512|NCT03818854|183331957|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||The analysis is for the change in RALE scores from the baseline to day 2.||||0.25
91719513|NCT03818854|183331957|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||The analysis is for the change in RALE scores from the baseline to day 3.||||0.69
91719514|NCT03818854|183331957|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||The analysis is for the change in RALE scores from the baseline to day 7.||||0.08
91526961|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3332|TWO_SIDED|95.0|-1.2|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 4 SCCAI score||3.5|-1.2|0.3332
91685298|NCT03104400|183260994|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.21||||0.0069|TWO_SIDED|95.0|-0.36|-0.06|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.06|-0.36|0.0069
91685299|NCT03104400|183260995|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.8|29.8||Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Cochran-Mantel-Haenszel||Response Rate Difference = Upadacitinib - Placebo|||29.8|18.8|<0.0001
91685300|NCT03104400|183260995|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|33.1|||<|0.0001|TWO_SIDED|95.0|27.4|38.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||38.8|27.4|<0.0001
91685301|NCT03104400|183260996|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|21.3|||<|0.0001|TWO_SIDED|95.0|13.0|29.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.7|13.0|<0.0001
91685302|NCT03104400|183260996|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|25.3|||<|0.0001|TWO_SIDED|95.0|16.9|33.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.7|16.9|<0.0001
91685303|NCT03104400|183260997|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|119.381|||<|0.0001|TWO_SIDED|95.0|97.987|147.942|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||147.942|97.987|<0.0001
91685304|NCT03104400|183260997|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|146.604|||<|0.0001|TWO_SIDED|95.0|122.817|180.398|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||180.398|122.817|<0.0001
91719515|NCT03818854|183331958|SUPERIORITY|||||||0.01||||||P-value was given by ordered logistic regression model.|Regression, Logistic|||||||0.01
91719516|NCT03818854|183331959|SUPERIORITY|||||||0.02||||||P-value was given by ordered logistic regression model.|Regression, Logistic|||||||0.02
91719517|NCT03818854|183331960|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91719518|NCT03818854|183331961|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
91719519|NCT03818854|183331962|SUPERIORITY|||||||0.36|||||||Fisher Exact|||The analysis is for the percentages of patients who developed incision/wound infection events by day 14.||||0.36
91719520|NCT03818854|183331962|SUPERIORITY|||||||0.5|||||||Fisher Exact|||The analysis is for the percentages of patients who developed organ/space infection events by day 14.||||0.50
91719521|NCT03818854|183331962|SUPERIORITY|||||||0.2|||||||Fisher Exact|||The analysis is for the percentages of patients who developed ventilator-associated pneumonia by day 14.||||0.20
91719522|NCT03818854|183331963|SUPERIORITY|||||||0.56||||||The threshold for statistical significance was p=0.05.|Chi-squared|||||||0.56
91719523|NCT03818854|183331964|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||The analysis for the SOFA score between two arms at Day 3.||||0.32
91719524|NCT03818854|183331964|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||The analysis for the SOFA score between two arms at Day 7.||||0.33
91719525|NCT03818854|183331965|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||The analysis is for non-pulmonary SOFA scores between the two arms at Day 3.||||0.39
91719526|NCT03818854|183331965|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||The analysis is for non-pulmonary SOFA scores between the two arms at Day 7.||||0.26
91685305|NCT03104400|183260998|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.67|||<|0.0001|TWO_SIDED|95.0|3.67|5.67|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.67|3.67|<0.0001
91685306|NCT03104400|183260998|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.72|||<|0.0001|TWO_SIDED|95.0|4.71|6.72|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.72|4.71|<0.0001
91685307|NCT03104400|183260999|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.7|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.7|2.4|<0.0001
91685308|NCT03104400|183260999|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.3|||<|0.0001|TWO_SIDED|95.0|3.1|5.5|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.5|3.1|<0.0001
91685309|NCT03104400|183261000|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|5.6||||0.0815|TWO_SIDED|95.0|-0.6|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||11.8|-0.6|0.0815
91685310|NCT03104400|183261000|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|7.5|19.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||19.4|7.5|<0.0001
91685311|NCT03104400|183261001|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.8|||<|0.0001|TWO_SIDED|95.0|25.7|47.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||47.9|25.7|<0.0001
91685312|NCT03104400|183261001|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.8|||<|0.0001|TWO_SIDED|95.0|28.8|50.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||50.9|28.8|<0.0001
91685313|NCT03104400|183261002|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|0.0||||0.897|TWO_SIDED|95.0|-0.3|0.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||0.3|-0.3|0.8970
91685314|NCT03104400|183261002|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.5||||0.0028|TWO_SIDED|95.0|-0.7|-0.2||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.2|-0.7|0.0028
91719527|NCT03818854|183331966|SUPERIORITY|||||||0.29||||||The threshold for statistical significance was p=0.05|Chi-squared|||The analysis is for the mortality between two arms at Day 14.||||0.29
91719528|NCT03818854|183331966|SUPERIORITY|||||||0.83|||||||Chi-squared|||The analysis is for the mortality between the two arms at Day 28.||||0.83
91719529|NCT03818854|183331966|SUPERIORITY|||||||0.56|||||||Chi-squared|||The analysis is for the mortality between the two arms at Day 60.||||0.56
91719530|NCT03818854|183331967|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91719531|NCT03818854|183331968|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Plasma angiopoietin-2 changes from the baseline between two arms at 6 hours since the initiation of the study product infusion.||||0.56
91719532|NCT03818854|183331968|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Plasma angiopoietin-2 changes from the baseline between two arms at 24 hours since the initiation of the study product infusion.||||0.79
91719533|NCT03818854|183331968|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Plasma angiopoietin-2 changes from the baseline between two arms at 48 hours since the initiation of the study product infusion.||||0.62
91719534|NCT03818854|183331968|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Plasma angiopoietin-2 changes from the baseline between two arms at 72 hours since the initiation of the study product infusion.||||0.67
91719535|NCT03818854|183331969|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Plasma RAGE changes from the baseline between two arms at 6 hours since the initiation of the study product infusion.||||0.60
91719536|NCT03818854|183331969|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Plasma RAGE changes from the baseline between two arms at 24 hours since the initiation of the study product infusion.||||0.04
91719537|NCT03818854|183331969|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Plasma RAGE changes from the baseline between two arms at 48 hours since the initiation of the study product infusion.||||0.09
91719538|NCT03818854|183331969|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Plasma RAGE changes from the baseline between two arms at 72 hours since the initiation of the study product infusion.||||0.38
91719539|NCT03818854|183331970|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-6 changes from the baseline between two arms at 6 hours since the initiation of the study product infusion.||||0.28
91719540|NCT03818854|183331970|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-6 changes from the baseline between two arms at 24 hours since the initiation of the study product infusion.||||0.10
91719541|NCT03818854|183331970|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-6 changes from the baseline between two arms at 48 hours since the initiation of the study product infusion.||||0.15
91719542|NCT03818854|183331970|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-6 changes from the baseline between two arms at 72 hours since the initiation of the study product infusion.||||0.34
91526962|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6985|TWO_SIDED|95.0|-1.6|2.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 4 SCCAI score||2.4|-1.6|0.6985
91719543|NCT03818854|183331971|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-8 changes from the baseline between two arms at 6 hours since the initiation of the study product infusion.||||0.85
91719544|NCT03818854|183331971|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-8 changes from the baseline between two arms at 24 hours since the initiation of the study product infusion.||||0.50
91719545|NCT03818854|183331971|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-8 changes from the baseline between two arms at 48 hours since the initiation of the study product infusion.||||0.64
91719546|NCT03818854|183331971|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Plasma IL-8 changes from the baseline between two arms at 72 hours since the initiation of the study product infusion.||||0.70
91719547|NCT03818854|183331972|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of TNFR-1 at 6 hours since the initiation of study product infusion from the baseline.||||0.32
91719548|NCT03818854|183331972|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of TNFR-1 at 24 hours since the initiation of study product infusion from the baseline.||||0.02
91719549|NCT03818854|183331972|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of TNFR-1 at 48 hours since the initiation of study product infusion from the baseline.||||0.02
91719550|NCT03818854|183331972|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of TNFR-1 at 72 hours since the initiation of study product infusion from the baseline.||||0.19
91719551|NCT03818854|183331973|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of Protein C at 6 hours since the initiation of study product infusion from the baseline.||||0.16
91719552|NCT03818854|183331973|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of Protein C at 24 hours since the initiation of study product infusion from the baseline.||||0.64
91719553|NCT03818854|183331973|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of Protein C at 48 hours since the initiation of study product infusion from the baseline.||||0.80
91719554|NCT03818854|183331973|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of Protein C at 72 hours since the initiation of study product infusion from the baseline.||||0.40
91719555|NCT03818854|183331974|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of ANG-1 at 6 hours since the initiation of study product infusion from the baseline.||||0.85
91719556|NCT03818854|183331974|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of ANG-1 at 24 hours since the initiation of study product infusion from the baseline.||||0.22
91719557|NCT03818854|183331974|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of ANG-1 at 48 hours since the initiation of study product infusion from the baseline.||||0.61
91719558|NCT03818854|183331974|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The analysis for the changes of ANG-1 at 72 hours since the initiation of study product infusion from the baseline.||||0.98
91719559|NCT03818854|183331980|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91719560|NCT01420536|183331988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.||||0.569
91719561|NCT01420536|183331989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.339
91685315|NCT03104400|183261003|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.08||||0.0162|TWO_SIDED|95.0|-0.15|-0.01||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.01|-0.15|0.0162
91685316|NCT03104400|183261003|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.2|-0.07||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.07|-0.20|<0.0001
91685317|NCT03104400|183261004|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-17.1|||<|0.0001|TWO_SIDED|95.0|-19.6|-14.6||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-14.6|-19.6|<0.0001
91685318|NCT03104400|183261004|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-22.3|-17.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-17.3|-22.3|<0.0001
91685319|NCT03104400|183261005|OTHER||Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.7|29.9||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.7|<0.0001
91685320|NCT03104400|183261005|OTHER||Response Rate Difference|38.5|||<|0.0001|TWO_SIDED|95.0|32.8|44.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||44.3|32.8|<0.0001
91685321|NCT03104400|183261006|OTHER||Response Rate Difference|13.3|||<|0.0001|TWO_SIDED|95.0|9.5|17.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||17.0|9.5|<0.0001
91685322|NCT03104400|183261006|OTHER||Response Rate Difference|22.9|||<|0.0001|TWO_SIDED|95.0|18.5|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||27.3|18.5|<0.0001
91685323|NCT03104400|183261007|OTHER||Response Rate Difference|16.1|||<|0.0001|TWO_SIDED|95.0|10.9|21.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.4|10.9|<0.0001
91685324|NCT03104400|183261007|OTHER||Response Rate Difference|26.2|||<|0.0001|TWO_SIDED|95.0|20.7|31.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||31.8|20.7|<0.0001
91685325|NCT01191944|183261017|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority (NI) margin of -4 points|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.9192|<|0.0001||95.0|-1.047|2.566||one-sided test relative to NI margin of -4|ANCOVA|adjusted for treatment, centre and baseline|Pramipexole IR minus Pramipexole ER, Pramipexole ER non inferior to Pramipexole IR if lower limit of confidence interval (CI) for the mean difference is higher than NI margin.|The null hypothesis (H0) states that the mean change from baseline to Week 18 (or last observation carried forward \[LOCF\]) in the UPDRS II+III score for the treatment group pramipexole ER is inferior to the mean change for the treatment group pramipexole IR.||2.566|-1.047|<0.0001
91685326|NCT01191944|183261018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.1836||0.8261|TWO_SIDED|95.0|-4.787|3.826|||ANCOVA|||||3.826|-4.787|0.8261
91685327|NCT01191944|183261019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.3274||0.8698|TWO_SIDED|95.0|-0.699|0.592|||ANCOVA|||||0.592|-0.699|0.8698
91685328|NCT01191944|183261020|SUPERIORITY_OR_OTHER|||||||0.7902||95.0|||||Cochran-Mantel-Haenszel|||||||0.7902
91685329|NCT01191944|183261021|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.763|STANDARD_ERROR_OF_MEAN|2.7845||0.3223|TWO_SIDED|95.0|-8.255|2.729|||ANCOVA|||||2.729|-8.255|0.3223
91685330|NCT01191944|183261022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|1.5581||0.0254|TWO_SIDED|95.0|0.437|6.583|||ANCOVA|||||6.583|0.437|0.0254
91685331|NCT01191944|183261023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.621|STANDARD_ERROR_OF_MEAN|2.2658||0.7843|TWO_SIDED|95.0|-3.848|5.09|||ANCOVA|||||5.090|-3.848|0.7843
91685332|NCT01191944|183261024|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.4901||0.4529|TWO_SIDED|95.0|-0.598|1.335|||ANCOVA|||||1.335|-0.598|0.4529
91685333|NCT01191944|183261025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.4437||0.2338|TWO_SIDED|95.0|-1.405|0.345|||ANCOVA|||||0.345|-1.405|0.2338
91685334|NCT01191944|183261026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562|STANDARD_ERROR_OF_MEAN|0.2509||0.0263|TWO_SIDED|95.0|0.067|1.057|||ANCOVA|||||1.057|0.067|0.0263
91685335|NCT01191944|183261027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.3727||0.9337|TWO_SIDED|95.0|-0.704|0.766|||ANCOVA|||||0.766|-0.704|0.9337
91685336|NCT01191944|183261028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.0798||0.6995|TWO_SIDED|95.0|-0.127|0.188|||ANCOVA|||||0.188|-0.127|0.6995
91685337|NCT01191944|183261029|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Cochran-Mantel-Haenszel|||||||0.3170
91685338|NCT01191944|183261030|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Cochran-Mantel-Haenszel|||||||0.4756
91685339|NCT01191944|183261031|SUPERIORITY_OR_OTHER|||||||0.1051||95.0|||||Cochran-Mantel-Haenszel|||||||0.1051
91685340|NCT01191944|183261032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.3138||0.6237|TWO_SIDED|95.0|-0.463|0.771|||ANCOVA|||||0.771|-0.463|0.6237
91685341|NCT01191944|183261034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.628|STANDARD_ERROR_OF_MEAN|0.7088||0.376|TWO_SIDED|95.0|-0.765|2.021|||ANCOVA|||||2.021|-0.765|0.3760
91685342|NCT02814890|183261039|OTHER|difference test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Sample size: Based on our previous data, pain score at rest 48 hours postoperatively when using ropivacaine only was of 2.8 with a standard deviation of 1.4. Assuming a decrease of pain score by 1.1 being clinically significant, twenty six patents in each group would be required for a study power of 80% (α=0.05,β=0.2). Considering possible dropouts, we aimed at recruiting 30 patients in each group with a total of 60 patients.||||0.001
91685343|NCT02814890|183261040|OTHER|difference test|Kendall's tau-b correlation coefficient|0.47|||||TWO_SIDED|||||||||||||
91685344|NCT02814890|183261042|SUPERIORITY||Risk Ratio (RR)|0.64|||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
91685345|NCT01753297|183261081|OTHER|||||||0.158|||||||Log Rank|||A two-sided log-rank test was used to compare time to BRFS between both treatment groups.|Analysis on BRFS was based on 61 BR events (comprised of 35 BR events in the active surveillance arm and 26 BR events in the triptorelin arm).|||0.158
91685346|NCT01753297|183261081|OTHER||Hazard Ratio (HR)|0.65||||0.1|TWO_SIDED|95.0|0.38|1.09|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute hazards ratios (HRs) and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||1.09|0.38|0.100
91526963|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3256|TWO_SIDED|95.0|-1.3|3.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 5 SCCAI score||3.7|-1.3|0.3256
91685347|NCT01753297|183261081|OTHER||Hazard Ratio (HR)|1.49||||0.502|TWO_SIDED|95.0|0.46|4.79|||Regression, Cox|||"Comparison between countries: Russia compared to China.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and country: p=0.970.|4.79|0.46|0.502
91685348|NCT01753297|183261081|OTHER|||||||0.671|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and centre: p=0.241.|||0.671
91685349|NCT01753297|183261081|OTHER||Hazard Ratio (HR)|2.35||||0.093|TWO_SIDED|95.0|0.87|6.39|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of =7 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and Gleason score: p=0.272.|6.39|0.87|0.093
91685350|NCT01753297|183261081|OTHER||Hazard Ratio (HR)|2.03||||0.168|TWO_SIDED|95.0|0.74|5.55|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of ≥8 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||5.55|0.74|0.168
91685351|NCT01753297|183261083|OTHER|||||||0.639|||||||Log Rank|||A two-sided log-rank test was used to compare time to EFS between both treatment groups.|Analysis was based on 2 EFS events in the active surveillance arm and 3 EFS events in the triptorelin arm.|||0.639
91685352|NCT01753297|183261083|OTHER||Hazard Ratio (HR)|1.52||||0.653|TWO_SIDED|95.0|0.24|9.59|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||9.59|0.24|0.653
91685353|NCT01753297|183261083|OTHER|||||||0.999|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.999
91685354|NCT01753297|183261083|OTHER|||||||1|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||1.000
91685355|NCT01753297|183261083|OTHER|||||||0.583|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.583
91685356|NCT01753297|183261085|OTHER|||||||0.557|||||||Log Rank|||A two-sided log-rank test was used to compare time to OS between both treatment groups.|1 death occurred in the active surveillance arm and 2 deaths occurred in the triptorelin arm.|||0.557
91685357|NCT01753297|183261088|OTHER|||||||0.525|||||||Log Rank|||A two-sided log-rank test was used to compare PSADT between both treatment groups.|Analysis was based on 9 PSADT events in the active surveillance arm and 6 PSADT events in the triptorelin arm.|||0.525
91685358|NCT01753297|183261088|OTHER||Hazard Ratio (HR)|1.72||||0.435|TWO_SIDED|95.0|0.44|6.73|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||6.73|0.44|0.435
91685359|NCT01753297|183261088|OTHER|||||||0.761|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.761
91685360|NCT01753297|183261088|OTHER|||||||0.652|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.652
91685361|NCT01753297|183261088|OTHER|||||||0.726|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.726
91685362|NCT00794339|183261126|EQUIVALENCE|equivalence margin=0||||||0.4883|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the the median survival was compared between the 2 groups.||||0.4883
91685363|NCT00794339|183261127|EQUIVALENCE|no equivalence margin|Slope|-0.1235|STANDARD_ERROR_OF_MEAN|1.6988||0.1924|TWO_SIDED||||||Regression, Logistic|||Logistic Regression Modeling Complete Metabolic Response by T/M Ratio||||0.1924
91685364|NCT00794339|183261128|EQUIVALENCE|equivalence margin = 0||||||0.309|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups: those at or above the median for T/M Ratio (7.3) vs. those below, and the time to primary tumor recurrence was compared between the 2 goups.||||0.3090
91685365|NCT00794339|183261129|EQUIVALENCE|equivalence margin=0||||||0.5291|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake ratio as a Predictor of PELVIC Lymph Node Metastases at Baseline||||0.5291
91685366|NCT00794339|183261129|EQUIVALENCE|equivalence margin=0||||||0.9684|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of COMMON ILIAC Lymph Node Metastases at Baseline||||0.9684
91685367|NCT00794339|183261129|EQUIVALENCE|equivalence margin=0||||||0.7327|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of Para Aortic Lymph Node Metastases at Baseline||||0.7327
91719562|NCT01420536|183331990|SUPERIORITY|||||||0.515||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.515
91685368|NCT00794339|183261139|EQUIVALENCE|equivalence margin=0||||||0.4981|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the time to observe new distant metastases was compared between the groups||||.4981
91685369|NCT04315506|183261161|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5384|TWO_SIDED|95.0|0.75|1.72||The analysis was a two-intervention arm comparison. Adjustments for multiple tests and outcomes were not required.|Regression, Logistic||Odds of quitting in Enuf Snuff group (SGR) compared to Enough Snuff (control)|||1.72|0.75|0.5384
91719563|NCT01420536|183331991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.485
91685370|NCT04315506|183261162|SUPERIORITY||Slope|-0.1057||||0.6624|TWO_SIDED|95.0|-0.5808|0.3693||P-value above is for the treatment-by-time squared term in the statistical model for longitudinal data; quadratic change in outcome determined, compared trajectory of outcome change in EnufSnuff (SGR) compared to Enough Snuff (control)|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted.|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.3693|-0.5808|0.6624
91685371|NCT04315506|183261163|SUPERIORITY||Slope|0.0946||||0.232|TWO_SIDED|95.0|-0.0609|0.2501||A multi-level, mixed-effects model for longitudinal data was applied. The p-value provided above was for the treatment-by-time effect used to test for differences in the trajectory of change in craving reduction between the two treatment groups.|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted. (trajectory analysis)|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.2501|-0.0609|0.2320
91685372|NCT03485365|183261184|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.18|STANDARD_DEVIATION|0.494|||TWO_SIDED|95.0|-2.15|-0.2|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||-0.20|-2.15|
91685373|NCT03485365|183261185|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.09|STANDARD_DEVIATION|0.612|||TWO_SIDED|95.0|-2.29|0.12|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||0.12|-2.29|
91685374|NCT03332979|183261219|OTHER|Multivariable regression analysis will be used to enable us to explore the impact of modifiable factors reflecting preparation for end of life on the MMCGI-SF.|||||<|0.05|||||||Regression, Linear||||Multivariable regression will be used to explore preparation for end of life on the MMCGI-SF. The analyses will use the MMCGI-SF as the dependent variable with five predictor variables (dementia knowledge \[DKAS\], Social support \[HLQ1\], Communication with healthcare professionals \[HLW4\], advance decisions and knowledge of end of life wishes of person with dementia. There will also be 10 confounders included in the model (gender of caregiver, living arrangement of person with dementia \[at home of a care home\], aged of person with dementia, dementia severity \[CDR\], change in closeness, religiosity \[DURAL\], deprivation and relationship of the carer to the person with dementia).|||<0.05
91685375|NCT03968978|183261259|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.5|93.67|
91685376|NCT03968978|183261259|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100|96.65|
91685377|NCT03968978|183261259|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
91685378|NCT03968978|183261259|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
91685379|NCT03968978|183261259|OTHER||Proportion|95.4|||||TWO_SIDED|95.0|89.71|98.02|||Score CI|CI for Week 16 (at home)||||98.02|89.71|
91685380|NCT03968978|183261259|OTHER||Proportion|96.3|||||TWO_SIDED|95.0|90.94|98.56|||Score CI|CI for Week 20 (in clinic)||||98.56|90.94|
91685381|NCT03968978|183261259|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.47|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.47|
91685382|NCT03968978|183261259|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 4 (in clinic)||||99.02|91.93|
91685383|NCT03968978|183261259|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Score CI|CI for Week 8 (in clinic)||||99.48|93.32|
91685384|NCT03968978|183261259|OTHER||Proportion|99.0|||||TWO_SIDED|95.0|94.8|99.83|||Score CI|CI for week 12 (at home)||||99.83|94.80|
91685385|NCT03968978|183261259|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 16 (at home)||||99.02|91.93|
91685386|NCT03968978|183261259|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 20 (in clinic)||||99.02|91.93|
91685387|NCT03968978|183261260|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.50|93.67|
91526964|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.65|TWO_SIDED|95.0|-1.9|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 5 SCCAI score||3.0|-1.9|0.6500
91685388|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100.00|96.65|
91685389|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
91685390|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
91685391|NCT03968978|183261260|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|92.8|99.04|||Score CI|CI for Week 16 (at home)||||99.04|92.80|
91685392|NCT03968978|183261260|OTHER||Proportion|99.1|||||TWO_SIDED|95.0|94.85|99.83|||Score CI|CI for Week 20 (in clinic)||||99.83|94.85|
91685393|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.46|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.46|
91685394|NCT03968978|183261260|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|93.38|99.48|||Score CI|CI for Week 4 (in clinic)||||99.48|93.38|
91685395|NCT03968978|183261260|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Other CI|CI for Week 8 (in clinic)||||99.48|93.32|
91685396|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.44|100.0|||Score CI|CI for week 12 (at home)||||100.00|96.44|
91685397|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 16 (at home)||||100.00|96.37|
91685398|NCT03968978|183261260|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 20 (in clinic)||||100.00|96.37|
91685399|NCT03968978|183261261|OTHER||Proportion|1.8|||||TWO_SIDED|95.0|0.5|6.33|||Score CI|CI at Week 0 (in clinic)||||6.33|0.50|
91685400|NCT03968978|183261261|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.35|||Score CI|CI at Week 4 (in clinic)||||3.35|0|
91685401|NCT03968978|183261261|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 8 (in clinic)||||3.37|0|
91685402|NCT03968978|183261261|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 12 (at home)||||3.37|0|
91685403|NCT03968978|183261261|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.96|7.92|||Score CI|CI for Week 16 (at home)||||7.92|0.96|
91526965|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8758|TWO_SIDED|95.0|-2.3|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 5 SCCAI score||2.7|-2.3|0.8758
91685404|NCT03968978|183261261|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.17|5.15|||Score CI|CI for Week 20 (in clinic)||||5.15|0.17|
91685405|NCT03968978|183261261|SUPERIORITY||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.53|||Score CI|CI for Week 0 (in clinic)||||3.53|0|
91685406|NCT03968978|183261261|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.97|7.99|||Score CI|CI for Week 4 (in clinic)||||7.99|0.97|
91685407|NCT03968978|183261261|OTHER||Proportion|1.9|||||TWO_SIDED|95.0|0.52|6.68|||Other CI|CI for Week 8 (in clinic)||||6.68|0.52|
91685408|NCT03968978|183261261|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.56|||Score CI|CI for week 12 (at home)||||3.56|0|
91685409|NCT03968978|183261261|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 16 (at home)||||3.63|0|
91685410|NCT03968978|183261261|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 20 (in clinic)||||3.63|0|
91685411|NCT00863772|183261265|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.37||0.434|TWO_SIDED|95.0|-0.44|1.01|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||1.01|-0.44|0.434
91685412|NCT00863772|183261265|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.37||0.883|TWO_SIDED|95.0|-0.68|0.79|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.79|-0.68|0.883
91685413|NCT00863772|183261266|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.37||0.72|TWO_SIDED|95.0|-0.59|0.86|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.86|-0.59|0.720
91685414|NCT00863772|183261266|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.985|TWO_SIDED|95.0|-0.73|0.74|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.74|-0.73|0.985
91685415|NCT04080544|183261325|OTHER|Null-hypothesis significance testing|Slope|-1.42|STANDARD_ERROR_OF_MEAN|0.81||0.081|TWO_SIDED|95.0|-3.03|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to episodic memory.||0.18|-3.03|.081
91685416|NCT04080544|183261325|OTHER|Null-hypothesis significance test|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.604|TWO_SIDED|95.0|-0.32|0.19||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of episodic memory.||0.19|-0.32|.604
91685417|NCT04080544|183261326|OTHER|Null-hypothesis significance test|Slope|1.77|STANDARD_ERROR_OF_MEAN|0.81||0.033|TWO_SIDED|95.0|0.15|3.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for baseline age, sex, and years of education.||Regression testing the relationship between amyloid accumulation (annualized change score for amyloid SUVR) to temporal tau SUVR.||3.39|0.15|.033
91685418|NCT04080544|183261327|OTHER|Null-hypothesis significance testing|Slope|0.272|STANDARD_ERROR_OF_MEAN|0.7||0.699|TWO_SIDED|95.0|-1.12|1.66||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to speed of processing.||1.66|-1.12|.699
91685419|NCT04080544|183261327|OTHER|Null-hypothesis significance test|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.154|TWO_SIDED|95.0|-0.06|0.38||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in the prediction of speed of processing.||0.38|-0.06|.154
91685420|NCT04080544|183261328|OTHER|Null-hypothesis significance testing|Slope|-1.11|STANDARD_ERROR_OF_MEAN|0.74||0.137|TWO_SIDED|95.0|-2.58|0.36||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to reasoning function.||0.36|-2.58|.137
91685421|NCT04080544|183261328|OTHER|Null-hypothesis significance test|Slope|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.428|TWO_SIDED|95.0|-0.16|0.37||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of reasoning.||0.37|-0.16|.428
91685422|NCT04080544|183261329|OTHER|Null-hypothesis significance test|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.78||0.376|TWO_SIDED|95.0|-2.25|0.86||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to working memory.||0.86|-2.25|.376
91685423|NCT04080544|183261329|OTHER|Null-hypothesis significance test|Slope|0.27|STANDARD_ERROR_OF_MEAN|0.13||0.039|TWO_SIDED|95.0|0.01|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of working memory.||0.53|0.01|.039
91685424|NCT04080544|183261329|OTHER|Null-hypothesis significance test|Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.27||0.091|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD below the mean for amyloid||||.091
91685425|NCT04080544|183261329|OTHER|Null-hypothesis significance test|Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.296|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at the mean for amyloid SUVR||||.296
91685426|NCT04080544|183261329|OTHER|Null-hypothesis significance test|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.695|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD above the mean for amyloid SUVR||||.695
91685427|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.012|TWO_SIDED|95.0|0.0004|0.004||A prior threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to inferior temporal SUVR.||0.004|0.0004|.012
91685428|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|-0.000005|STANDARD_ERROR_OF_MEAN|0.00004||0.905|TWO_SIDED|95.0|-0.000009|0.00008||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to inferior temporal SUVR.||0.00008|-0.000009|.905
91685429|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.006|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to inferior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.006
91685430|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|0.0003|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to middle temporal gyrus SUVR.||0.003|0.0003|.018
91685431|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00004||0.579|TWO_SIDED|95.0|-0.0001|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustment for multiple comparisons.||Regression testing the relationship of age(quadratic) to middle temporal SUVR.||0.00006|-0.0001|.579
91685432|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.008|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to middle temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.008
91685433|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.00006|STANDARD_ERROR_OF_MEAN|0.0004||0.897|TWO_SIDED|95.0|-0.001|0.001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age to superior temporal SUVR.||0.001|-0.001|.897
91685434|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.539|TWO_SIDED|95.0|-0.00007|0.00003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to superior temporal SUVR.||0.00003|-0.00007|.539
91685435|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|-0.00001|STANDARD_ERROR_OF_MEAN|0.0004||0.973|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to superior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.973
91685436|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2|TWO_SIDED|95.0|-0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to entorhinal SUVR.||0.003|-0.001|.200
91685437|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.00005|STANDARD_ERROR_OF_MEAN|0.00005||0.346|TWO_SIDED|95.0|-0.00005|0.0001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to entorhinal SUVR.||0.0001|-0.00005|.346
91685438|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.283|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing relationship of age(growth model) to entorhinal SUVR. Growth modeling was performed using SPSS curve estimation.||||.283
91685439|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.011|TWO_SIDED|95.0|0.0004|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to parahippocampal SUVR.||0.003|0.0004|.011
91685440|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.536|TWO_SIDED|95.0|-0.00004|0.00009||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to parahippocampal SUVR.||0.00009|-0.00004|.536
91685441|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.013|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to parahippocampal SUVR. Growth modeling was performed using SPSS curve estimation.||||.013
91685442|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.0005|<|0.001|TWO_SIDED|95.0|0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to fusiform SUVR.||0.003|0.001|<.001
91685443|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.00001|STANDARD_ERROR_OF_MEAN|0.00003||0.692|TWO_SIDED|95.0|-0.00004|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to fusiform SUVR.||0.00006|-0.00004|.692
91685444|NCT04080544|183261330|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.0004|<|0.001|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to fusiform SUVR. Growth modeling was performed using SPSS curve estimation.||||<.001
91526966|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.7298|TWO_SIDED|95.0|-2.1|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 5 SCCAI score||3.0|-2.1|0.7298
91719564|NCT01420536|183331992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.111
91685445|NCT04080544|183261331|OTHER|Null-hypothesis significance testing|Slope|0.18|STANDARD_ERROR_OF_MEAN|0.18||0.331|TWO_SIDED|95.0|-0.18|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to inferior temporal gyrus cortical thickness.||0.53|-0.18|.331
91685446|NCT04080544|183261331|OTHER|Null-hypothesis significance testing|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.636|TWO_SIDED|95.0|-0.24|0.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education||Regression testing the relationship between temporal tau SUVR to middle temporal gyrus cortical thickness.||0.39|-0.24|.636
91685447|NCT04080544|183261331|OTHER|Null-hypothesis significance testing|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.16||0.024|TWO_SIDED|95.0|0.05|0.7||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to superior temporal gyrus cortical thickness.||0.70|0.05|.024
91685448|NCT04080544|183261331|OTHER|Null-hypothesis significance testing|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.235|TWO_SIDED|95.0|-0.73|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to parahippocampal gyrus cortical thickness.||0.18|-0.73|.235
91685449|NCT04080544|183261331|OTHER|Null-hypothesis significance testing|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.639|TWO_SIDED|95.0|-0.63|1.01||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to entorhinal gyrus cortical thickness.||1.01|-0.63|.639
91685450|NCT04080544|183261331|OTHER|Null-hypothesis significance test|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.16||0.252|TWO_SIDED|95.0|-0.13|0.5||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to fusiform gyrus cortical thickness.||0.50|-0.13|.252
91685451|NCT04080544|183261332|OTHER|Null-hypothesis significance test|Slope|-233.74|STANDARD_ERROR_OF_MEAN|469.31||0.619|TWO_SIDED|95.0|-1163.28|695.79||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to hippocampal volume.||695.79|-1163.28|.619
91685452|NCT04080544|183261333|OTHER|Null-hypothesis significance test|Slope|9260.01|STANDARD_ERROR_OF_MEAN|3836.92||0.017|TWO_SIDED|95.0|1660.52|16859.51||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to volume of white matter hypointensities.||16859.51|1660.52|.017
91685453|NCT04080544|183261334|OTHER|Null-hypothesis significance test|Slope|0.29|STANDARD_ERROR_OF_MEAN|0.35||0.411|TWO_SIDED|95.0|-0.41|0.99||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to activation of inferior frontal gyrus (beta) on the semantic judgment fMRI task.||0.99|-0.41|.411
91685454|NCT04080544|183261334|OTHER|Null-hypothesis significance test|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.34|0.81||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to middle temporal gyrus activation (beta) on the semantic judgment fMRI task.||0.81|-0.34|.412
91685455|NCT04080544|183261334|OTHER|Null-hypothesis significance test|Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.438|TWO_SIDED|95.0|-0.48|1.09||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to precuneus gyrus activation (beta) on the semantic judgment fMRI task.||1.09|-0.48|.438
91685456|NCT04080544|183261335|OTHER|Null-hypothesis significance test|Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.5||0.026|TWO_SIDED|95.0|-2.12|-0.14||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to resting-state system segregation.||-0.14|-2.12|.026
91685457|NCT04400682|183261345|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean ratio|1.015||||0|TWO_SIDED|90.0|0.9897|1.041|||ANOVA||||Ln(AUClast) : 0.989- 1.0410|1.0410|0.9897|0.0000
91685458|NCT04400682|183261346|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean ratio|1.0361||||0.0033|TWO_SIDED|90.0|0.9294|1.1551|||ANOVA||||Ln(Cmax) : 0.9294 - 1.1551|1.1551|0.9294|0.0033
91685459|NCT04400682|183261347|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean ratio|1.0108||||0|TWO_SIDED|90.0|0.9856|1.0366|||ANOVA||||Ln(Cmax) : 0.9856 - 1.0366|1.0366|0.9856|0.0000
91685460|NCT02105974|183261349|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034||||0.001|TWO_SIDED|95.0|0.014|0.055|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.055|0.014|0.001
91685461|NCT02105974|183261350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62||||0.084|TWO_SIDED|95.0|-0.35|5.59|||ANCOVA|||||5.59|-0.35|0.084
91685462|NCT02105974|183261351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.43|0.78||Nominal p-value|Regression, Cox|||||0.78|0.43|<0.001
91685463|NCT03597464|183261353|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.05|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||4.05|1.30|0.004
91685464|NCT03597464|183261353|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.25|3.83|||Regression, Logistic|||Month 18||3.83|1.25|0.006
91685465|NCT03597464|183261353|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.81||||0.035|TWO_SIDED|95.0|1.04|3.16|||Regression, Logistic|||Month 24||3.16|1.04|0.035
91685466|NCT03597464|183261353|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.28|3.92|||Regression, Logistic|||Month 30||3.92|1.28|0.005
91685467|NCT03597464|183261353|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.74||||0.051|TWO_SIDED|95.0|1.0|3.03|||Regression, Logistic|||Month 36||3.03|1.00|0.051
91685468|NCT03597464|183261354|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.88|8.46|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||8.46|1.88|<0.001
91685469|NCT03597464|183261354|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.5||||0.008|TWO_SIDED|95.0|1.28|4.88|||Regression, Logistic|||Month 18||4.88|1.28|0.008
91685470|NCT03597464|183261354|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.68||||0.001|TWO_SIDED|95.0|1.46|4.91|||Regression, Logistic|||Month 24||4.91|1.46|0.001
91685471|NCT03597464|183261354|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.86||||0.04|TWO_SIDED|95.0|1.03|3.34|||Regression, Logistic|||Month 30||3.34|1.03|0.040
91685472|NCT03597464|183261354|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.39||||0.29|TWO_SIDED|95.0|0.75|2.58|||Regression, Logistic|||Month 36||2.58|0.75|0.290
91685473|NCT03597464|183261355|OTHER||Odds Ratio (OR)|0.56||||0.045|TWO_SIDED|95.0|0.32|0.99|||Regression, Logistic|||Number of subjects with adequate renal response. This model is based on a logistic regression with terms for treatment, baseline urine protein creatinine ratio (UPCR), biopsy class, mycophenolate mofetil (MMF) use at baseline and region. An odds ratio \< unity indicates benefit for voclosporin.||0.99|0.32|0.045
91685474|NCT03597464|183261356|SUPERIORITY||Least Squares Mean difference|-0.8||||0.238|TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||Month 18||0.5|-2.1|0.238
91685475|NCT03597464|183261356|SUPERIORITY||Least Squares Mean difference|-0.7||||0.215|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||Month 24||0.4|-1.8|0.215
91685476|NCT03597464|183261356|SUPERIORITY||Least Squares Mean difference|-0.7||||0.246|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||Month 36||0.5|-1.8|0.246
91685477|NCT03597464|183261357|SUPERIORITY||Least Squares Mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.05|-0.26|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.26|-1.05|0.001
91685478|NCT03597464|183261357|SUPERIORITY||Least Squares Mean difference|-0.63||||0.029|TWO_SIDED|95.0|-1.2|-0.07|||Mixed Models Analysis|||Month 18||-0.07|-1.20|0.029
91685479|NCT03597464|183261357|SUPERIORITY||Least Squares Mean difference|-0.77||||0.002|TWO_SIDED|95.0|-1.24|-0.29|||Mixed Models Analysis|||Month 24||-0.29|-1.24|0.002
91685480|NCT03597464|183261357|SUPERIORITY||Least Squares Mean difference|-0.91||||0.002|TWO_SIDED|95.0|-1.49|-0.33|||Mixed Models Analysis|||Month 30||-0.33|-1.49|0.002
91526967|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5963|TWO_SIDED|95.0|-2.8|1.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 5 SCCAI score||1.6|-2.8|0.5963
91685481|NCT03597464|183261357|SUPERIORITY||Least Squares Mean difference|-0.48||||0.106|TWO_SIDED|95.0|-1.06|-0.1|||Mixed Models Analysis|||Month 36||-0.10|-1.06|0.106
91685482|NCT03597464|183261358|SUPERIORITY||Least Squares Mean difference|-2.7||||0.041|TWO_SIDED|95.0|-5.3|-0.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.1|-5.3|0.041
91685483|NCT03597464|183261358|SUPERIORITY||Least Squares Mean difference|-1.8||||0.292|TWO_SIDED|95.0|-5.1|1.6|||Mixed Models Analysis|||Month 18||1.6|-5.1|0.292
91685484|NCT03597464|183261358|SUPERIORITY||Least Squares Mean difference|-2.2||||0.282|TWO_SIDED|95.0|-6.1|1.8|||Mixed Models Analysis|||Month 24||1.8|-6.1|0.282
91685485|NCT03597464|183261358|SUPERIORITY||Least Squares Mean difference|0.9||||0.659|TWO_SIDED|95.0|-3.2|5.1|||Mixed Models Analysis|||Month 30||5.1|-3.2|0.659
91685486|NCT03597464|183261358|SUPERIORITY||Least Squares Mean difference|1.8||||0.438|TWO_SIDED|95.0|-2.8|6.4|||Mixed Models Analysis|||Month 36||6.4|-2.8|0.438
91685487|NCT03597464|183261359|SUPERIORITY||Least Squares Mean difference|-67.7||||0.002|TWO_SIDED|95.0|-110.4|-25.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-25.1|-110.4|0.002
91685488|NCT03597464|183261359|SUPERIORITY||Least Squares Mean difference|-87.7||||0.007|TWO_SIDED|95.0|-151.2|-24.2|||Mixed Models Analysis|||Month 18||-24.2|-151.2|0.007
91685489|NCT03597464|183261359|SUPERIORITY||Least Squares Mean difference|-47.0||||0.035|TWO_SIDED|95.0|-90.8|-3.3|||Mixed Models Analysis|||Month 24||-3.3|-90.8|0.035
91487378|NCT02642029|182847286|OTHER||beta coefficient for delusions of contro|-0.00038||||0.777|TWO_SIDED|95.0|-0.00305|0.00228||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, delusions of control). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00228|-0.00305|0.777
91487379|NCT01426438|182847300|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.28
91685490|NCT03597464|183261359|SUPERIORITY||Least Squares Mean difference|-73.1||||0.005|TWO_SIDED|95.0|-123.5|-22.6|||Mixed Models Analysis|||Month 30||-22.6|-123.5|0.005
91487380|NCT01426438|182847300|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.19
91487381|NCT01788046|182847314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.8|||<|0.001|TWO_SIDED|95.0|18.18|52.17|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of percentage of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||52.17|18.18|< 0.001
91685491|NCT03597464|183261359|SUPERIORITY||Least Squares Mean difference|-19.0||||0.537|TWO_SIDED|95.0|-79.7|41.7|||Mixed Models Analysis|||Month 36||41.7|-79.7|0.537
91685492|NCT03597464|183261360|SUPERIORITY||Least Squares Mean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.035|0.134|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||0.134|0.035|<0.001
91685493|NCT03597464|183261360|SUPERIORITY||Least Squares Mean difference|0.051||||0.209|TWO_SIDED|95.0|-0.029|0.131|||Mixed Models Analysis|||Month 18||0.131|-0.029|0.209
91685494|NCT03597464|183261360|SUPERIORITY||Least Squares Mean difference|0.057||||0.353|TWO_SIDED|95.0|-0.064|0.178|||Mixed Models Analysis|||Month 24||0.178|-0.064|0.353
91685495|NCT03597464|183261360|SUPERIORITY||Least Squares Mean difference|-0.036||||0.616|TWO_SIDED|95.0|-0.176|0.105|||Mixed Models Analysis|||Month 30||0.105|-0.176|0.616
91685496|NCT03597464|183261360|SUPERIORITY||Least Squares Mean difference|-0.077||||0.372|TWO_SIDED|95.0|-0.248|0.094|||Mixed Models Analysis|||Month 36||0.094|-0.248|0.372
91685497|NCT00447876|183261382|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.2|||=|0.182|TWO_SIDED|95.0|-0.06|0.46|||Fisher Exact|||The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.||0.46|-0.06|=0.182
91685498|NCT00447876|183261383|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.222|||||||Cochran-Mantel-Haenszel|||Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.||||=0.222
91685499|NCT00447876|183261385|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.837|||=|0.423|TWO_SIDED|95.0|-30.94|13.266|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||13.266|-30.940|=0.423
91685500|NCT00447876|183261387|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.173|||=|0.682|TWO_SIDED|95.0|-24.64|16.294|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||16.294|-24.640|=0.682
91685501|NCT00447876|183261389|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.066|||=|0.438|TWO_SIDED|95.0|-28.91|12.779|||ANCOVA|||The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||12.779|-28.910|=0.438
91685502|NCT00447876|183261391|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.594|||=|0.937|TWO_SIDED|95.0|-14.575|15.762|||ANCOVA|||The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||15.762|-14.575|=0.937
91685503|NCT00447876|183261392|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||=|0.8|TWO_SIDED|95.0|-6.8|5.3||The difference (most affected side - control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.|ANCOVA|||||5.3|-6.8|=0.800
91685504|NCT00447876|183261393|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.862|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.862
91685505|NCT00447876|183261393|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.317|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.317
91685506|NCT00447876|183261393|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.525|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.525
91685507|NCT00447876|183261393|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.931
91685508|NCT00447876|183261393|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.353|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.353
91685509|NCT00447876|183261394|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.882|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.882
91685510|NCT00447876|183261394|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.489|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.489
91685511|NCT00447876|183261394|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.66|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.660
91685512|NCT00447876|183261394|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.485|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.485
91685513|NCT00447876|183261394|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.392|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.392
91685514|NCT02952586|183261404|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9199|TWO_SIDED|95.0|0.928|1.573||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.573|0.928|0.9199
91685515|NCT02952586|183261405|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.9372|TWO_SIDED|95.0|0.927|1.849||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.849|0.927|0.9372
91685516|NCT02952586|183261407|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.9316|TWO_SIDED|95.0|0.93|1.694||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.694|0.930|0.9316
91685517|NCT02952586|183261408|SUPERIORITY||Odds Ratio (OR)|0.947||||0.6229|TWO_SIDED|95.0|0.663|1.352||The treatment arms were compared using a stratified, 1-sided, Cochran-Mantel-Haenszel Test. The 3 stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Cochran-Mantel-Haenszel|||||1.352|0.663|0.6229
91685518|NCT02952586|183261409|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9061|TWO_SIDED|95.0|0.909|1.624||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Log Rank|||||1.624|0.909|0.9061
91685519|NCT01931878|183261429|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||t-test, 2 sided|||comparison of mean RLS Scale scores between 21 incoA and 21 saline injections||||0.031
91685520|NCT01931878|183261430|SUPERIORITY_OR_OTHER|||||||0.0088|TWO_SIDED||||||Fisher Exact|||||||0.0088
91685521|NCT01931878|183261431|SUPERIORITY_OR_OTHER|||||||0.0855|TWO_SIDED||||||Fisher Exact|||||||0.0855
91685522|NCT00789035|183261457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.74|-0.29||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 5mg minus placebo|||-0.29|-0.74|<0.0001
91685523|NCT00789035|183261457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.35||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 10mg minus placebo|||-0.35|-0.80|<0.0001
91685524|NCT00789035|183261457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.94|-0.5||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 25mg minus placebo|||-0.50|-0.94|<0.0001
91487382|NCT01788046|182847315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.92|||<|0.001|TWO_SIDED|95.0|16.35|70.37|||Cochran-Mantel-Haenszel|Stratified by screening PTH category, prior cinacalcet use within 8 weeks prior to randomization, and region.||||70.37|16.35|< 0.001
91487383|NCT01788046|182847316|SUPERIORITY_OR_OTHER||Mean Difference|-71.34|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-77.53|-65.14|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-65.14|-77.53|< 0.001
91487384|NCT01788046|182847317|SUPERIORITY_OR_OTHER||Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-8.38|-6.03|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-6.03|-8.38|< 0.001
91487385|NCT01788046|182847318|SUPERIORITY_OR_OTHER||Mean Difference|-14.58|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-18.65|-10.51|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.51|-18.65|< 0.001
91487386|NCT01788046|182847319|SUPERIORITY_OR_OTHER||Mean Difference|-8.04|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.15|-3.92|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-3.92|-12.15|< 0.001
91487387|NCT02038881|182847376|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.851|||||TWO_SIDED|95.0|0.258|2.8||||||||2.800|0.258|
91685525|NCT00295061|183261587|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 20 subjects could demonstrate comparability of an AUC(0-7days) with 90% power up to a standard deviation of 0.288 of the difference in the log scale, expected mean treatment difference of 0 (= ratio of 1), a lower equivalence limit of -0.223 (= log 0.8), upper limit of 0.223 (= log 1.25) and a one-sided alpha of 0.05 (90% CI).|Geometric least square means ratio|1.03||||||90.0|0.97|1.09||||||To compare AUC 0-7 days between the two treatments (Alpha-1 MP vs. Prolastin),natural log-transformed AUC 0-7 days values were analyzed by analysis of variance (ANOVA).||1.09|0.97|
91487388|NCT02038881|182847376|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.653|||||TWO_SIDED|95.0|0.319|1.333||||||||1.333|0.319|
91685526|NCT00711880|183261591|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.96||||0.004|TWO_SIDED|95.0|-1.59|-0.32|||ANCOVA|||The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.||-0.32|-1.59|0.004
91685527|NCT00711880|183261592|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.03||||0.007|TWO_SIDED|95.0|-13.83|-2.23|||ANCOVA|||The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.||-2.23|-13.83|0.007
91685528|NCT00711880|183261593|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.43||||0.001|TWO_SIDED|95.0|-0.67|-0.19|||ANCOVA|||The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.||-0.19|-0.67|0.001
91685529|NCT00711880|183261594|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.85||||0.003|TWO_SIDED|95.0|-9.62|-2.09|||ANCOVA|||The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.||-2.09|-9.62|0.003
91685530|NCT00711880|183261595|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.82||||0.042|TWO_SIDED|95.0|-1.6|-0.03|||ANCOVA|||The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.||-0.03|-1.60|0.042
91685531|NCT00711880|183261596|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|12.73||||0.144|TWO_SIDED|95.0|-4.4|29.85|||ANCOVA|||The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.||29.85|-4.40|0.144
91685532|NCT00711880|183261597|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.75||||0.483|TWO_SIDED|95.0|-2.84|1.35|||ANCOVA|||The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.||1.35|-2.84|0.483
91685533|NCT00711880|183261598|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.46|0.5|||ANCOVA|||The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.||0.50|-0.46|0.924
91685534|NCT00711880|183261599|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.53||||0.214|TWO_SIDED|95.0|-0.31|1.38|||ANCOVA|||The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.||1.38|-0.31|0.214
91685535|NCT00711880|183261600|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.15||||0.158|TWO_SIDED|95.0|-5.15|0.85|||ANCOVA|||The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.||0.85|-5.15|0.158
91685536|NCT00711880|183261601|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.28||||0.656|TWO_SIDED|95.0|-4.47|7.04|||ANCOVA|||The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.||7.04|-4.47|0.656
91487389|NCT02038881|182847376|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|1.126|||||TWO_SIDED|95.0|0.291|4.352||||||||4.352|0.291|
91487390|NCT02038881|182847376|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.916|||||TWO_SIDED|95.0|0.22|3.819||||||||3.819|0.220|
91487391|NCT02038881|182847376|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|1.045|||||TWO_SIDED|95.0|0.292|3.741||||||||3.741|0.292|
91487392|NCT02038881|182847376|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.315|||||TWO_SIDED|95.0|0.598|2.892||||||||2.892|0.598|
91487393|NCT02038881|182847377|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.762|||||TWO_SIDED|95.0|0.385|1.507||||||||1.507|0.385|
91487394|NCT02038881|182847378|OTHER||GMT Ratio (Group 1 [W6]/ Group 3 [W14)|0.347|||||TWO_SIDED|95.0|0.2|0.603||||||||0.603|0.200|
91487395|NCT02038881|182847378|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.532|||||TWO_SIDED|95.0|0.285|0.992||||||||0.992|0.285|
91487396|NCT02038881|182847379|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|4.138|||||TWO_SIDED|95.0|1.241|13.793||||||||13.793|1.241|
91487397|NCT02038881|182847379|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|4.608|||||TWO_SIDED|95.0|1.365|15.558||||||||15.558|1.365|
91487398|NCT02038881|182847379|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.215|||||TWO_SIDED|95.0|0.066|0.699||||||||0.699|0.066|
91487399|NCT02038881|182847379|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.237|||||TWO_SIDED|95.0|0.072|0.782||||||||0.782|0.072|
91487400|NCT02038881|182847380|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.823|||||TWO_SIDED|95.0|0.333|2.038||||||||2.038|0.333|
91487401|NCT02038881|182847380|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.787|||||TWO_SIDED|95.0|0.41|1.508||||||||1.508|0.410|
91487402|NCT02038881|182847380|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|0.535|||||TWO_SIDED|95.0|0.187|1.536||||||||1.536|0.187|
91487403|NCT02038881|182847380|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.59|||||TWO_SIDED|95.0|0.203|1.716||||||||1.716|0.203|
91487404|NCT02038881|182847380|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|2.557|||||TWO_SIDED|95.0|0.972|6.731||||||||6.731|0.972|
91487405|NCT02038881|182847380|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.215|||||TWO_SIDED|95.0|0.612|2.412||||||||2.412|0.612|
91487406|NCT02038881|182847381|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.878|||||TWO_SIDED|95.0|0.48|1.606||||||||1.606|0.480|
91685537|NCT00711880|183261602|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.962|TWO_SIDED|95.0|-3.56|3.39|||ANCOVA|||The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.||3.39|-3.56|0.962
91685538|NCT00711880|183261603|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|32.26|||<|0.001|TWO_SIDED|95.0|16.4|48.12|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||48.12|16.40|<0.001
91685539|NCT00711880|183261605|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|29.03||||0.001||95.0|13.39|44.67|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||44.67|13.39|0.001
91487407|NCT02038881|182847382|OTHER||GMT ratio (Group 1 [W6]/ Group 3 [W14)|0.281|||||TWO_SIDED|95.0|0.146|0.542||||||||0.542|0.146|
91487408|NCT02038881|182847382|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.357|||||TWO_SIDED|95.0|0.178|0.718||||||||0.718|0.178|
91487409|NCT02038881|182847383|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|6.727|||||TWO_SIDED|95.0|2.493|18.15||||||||18.150|2.493|
91487410|NCT02038881|182847383|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|7.275|||||TWO_SIDED|95.0|2.693|19.649||||||||19.649|2.693|
91487411|NCT02038881|182847383|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.278|||||TWO_SIDED|95.0|0.115|0.672||||||||0.672|0.115|
91487412|NCT02038881|182847383|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.233|||||TWO_SIDED|95.0|0.1|0.541||||||||0.541|0.100|
91487413|NCT02038881|182847384|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-7.6|||||TWO_SIDED|95.0|-34.1|17.9||||||||17.9|-34.1|
91487414|NCT02038881|182847384|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
91487415|NCT02038881|182847384|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|5.1|||||TWO_SIDED|95.0|-24.5|32.6||||||||32.6|-24.5|
91487416|NCT02038881|182847384|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-1.5|||||TWO_SIDED|95.0|-31.5|29.2||||||||29.2|-31.5|
91487417|NCT02038881|182847384|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|-5.8|||||TWO_SIDED|95.0|-32.8|22.2||||||||22.2|-32.8|
91685540|NCT00704132|183261607|SUPERIORITY_OR_OTHER||Difference in Least-Squares Mean|-111.0|||<|0.001||95.0|-158.0|-63.9|||ANCOVA||Sitagliptin minus Placebo|||-63.9|-158.0|<0.001
91487418|NCT02038881|182847384|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-7.7|||||TWO_SIDED|95.0|-25.1|10.1||||||||10.1|-25.1|
91487419|NCT02038881|182847385|OTHER||Difference in seroconversion rates (%)|-4.3|||||TWO_SIDED|95.0|-15.2|11.6||||||||11.6|-15.2|
91487420|NCT02038881|182847386|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
91487421|NCT02038881|182847386|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
91487422|NCT02038881|182847387|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|5.6|||||TWO_SIDED|95.0|-19.6|33.0||||||||33.0|-19.6|
91487423|NCT02038881|182847387|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|16.7|||||TWO_SIDED|95.0|-11.0|44.4||||||||44.4|-11.0|
91487424|NCT02038881|182847387|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-10.6|||||TWO_SIDED|95.0|-35.6|14.3||||||||14.3|-35.6|
91487425|NCT02038881|182847387|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-15.2|||||TWO_SIDED|95.0|-40.5|10.5||||||||10.5|-40.5|
91487426|NCT02038881|182847388|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-9.6|||||TWO_SIDED|95.0|-38.4|20.3||||||||20.3|-38.4|
91487427|NCT02038881|182847388|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
91487428|NCT02038881|182847388|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|-9.6|||||TWO_SIDED|95.0|-38.4|17.6||||||||17.6|-38.4|
91487429|NCT02038881|182847388|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-6.1|||||TWO_SIDED|95.0|-35.6|23.7||||||||23.7|-35.6|
91487430|NCT02038881|182847388|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|20.8|||||TWO_SIDED|95.0|-7.7|47.8||||||||47.8|-7.7|
91487431|NCT02038881|182847388|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-3.8|||||TWO_SIDED|95.0|-20.5|13.4||||||||13.4|-20.5|
91487432|NCT02038881|182847389|OTHER||Difference in seroconversion rates (%)|-2.2|||||TWO_SIDED|95.0|-12.0|13.2||||||||13.2|-12.0|
91487433|NCT02038881|182847390|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
91487434|NCT02038881|182847390|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
91487435|NCT02038881|182847391|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|19.4|||||TWO_SIDED|95.0|-4.5|45.8||||||||45.8|-4.5|
91487436|NCT02038881|182847391|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|29.2|||||TWO_SIDED|95.0|5.8|55.4||||||||55.4|5.8|
91685541|NCT04238650|183261619|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|||||TWO_SIDED|90.0|0.981|1.11||||||||1.11|0.981|
91487437|NCT02038881|182847391|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-9.8|||||TWO_SIDED|95.0|-33.0|11.7||||||||11.7|-33.0|
91487438|NCT02038881|182847391|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-23.1|||||TWO_SIDED|95.0|-46.7|-1.0||||||||-1.0|-46.7|
91526968|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6498|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 6 SCCAI score||3.1|-2.0|0.6498
91685542|NCT04238650|183261620|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.13|||||TWO_SIDED|90.0|1.03|1.24||||||||1.24|1.03|
91685543|NCT04238650|183261621|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUClast was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.997|1.11||||||||1.11|0.997|
91685544|NCT02585778|183261706|SUPERIORITY||LS Mean Difference|-47.8|||<|0.0001|TWO_SIDED|95.0|-60.7|-35.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-35.0|-60.7|<0.0001
91685545|NCT02585778|183261706|SUPERIORITY||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.4|-43.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-43.6|-54.4|<0.0001
91685546|NCT02585778|183261708|SUPERIORITY||LS Mean Difference|-50.6|||<|0.0001|TWO_SIDED|95.0|-63.4|-37.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.||-37.9|-63.4|<0.0001
91685547|NCT02585778|183261708|SUPERIORITY||LS Mean Difference|-51.6|||<|0.0001|TWO_SIDED|95.0|-56.9|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-46.4|-56.9|<0.0001
91685548|NCT02585778|183261709|SUPERIORITY||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-61.2|-35.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-35.5|-61.2|<0.0001
91685549|NCT02585778|183261709|SUPERIORITY||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-50.9|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-40.4|-50.9|<0.0001
91685550|NCT02585778|183261710|SUPERIORITY||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|95.0|-56.9|-32.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.8|-56.9|<0.0001
91685551|NCT02585778|183261710|SUPERIORITY||LS Mean Difference|-50.2|||<|0.0001|TWO_SIDED|95.0|-55.2|-45.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-45.3|-55.2|<0.0001
91685552|NCT02585778|183261711|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.9|-30.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-30.5|-54.9|<0.0001
91685553|NCT02585778|183261711|SUPERIORITY||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|95.0|-49.0|-39.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-39.2|-49.0|<0.0001
91685554|NCT02585778|183261712|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.2|-31.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-31.3|-54.2|<0.0001
91685555|NCT02585778|183261712|SUPERIORITY||LS Mean Difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-43.4|-33.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-33.9|-43.4|<0.0001
91487439|NCT01453725|182847405|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|31.2|||<|0.0001|TWO_SIDED|95.0|17.5|43.6||Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level|Stratified Miettinen and Nurminen Method|||||43.6|17.5|<0.0001
91487440|NCT01453725|182847406|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|33.8|||<|0.0001|TWO_SIDED|95.0|20.4|46.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||46.1|20.4|<0.0001
91487441|NCT01453725|182847407|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|28.0|||<|0.0001|TWO_SIDED|95.0|14.4|40.6||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||40.6|14.4|<0.0001
91487442|NCT01453725|182847408|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|15.2||||0.0136|TWO_SIDED|95.0|3.2|27.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||27.1|3.2|0.0136
91685556|NCT02585778|183261713|SUPERIORITY||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-49.4|-28.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-28.7|-49.4|<0.0001
91685557|NCT02585778|183261713|SUPERIORITY||LS Mean Difference|-36.7|||<|0.0001|TWO_SIDED|95.0|-40.9|-32.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.5|-40.9|<0.0001
91685558|NCT02585778|183261714|SUPERIORITY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|95.0|-37.8|-20.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-20.7|-37.8|<0.0001
91685559|NCT02585778|183261714|SUPERIORITY||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-24.1|-31.2|<0.0001
91685560|NCT02585778|183261715|SUPERIORITY||Odds Ratio (OR)|117.0|||<|0.0001|TWO_SIDED|95.0|13.1|1041.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||1041.8|13.1|<0.0001
91685561|NCT02585778|183261715|SUPERIORITY||Odds Ratio (OR)|84.6|||<|0.0001|TWO_SIDED|95.0|36.5|196.1||Threshold for significance at 0.05 level|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||196.1|36.5|<0.0001
91685562|NCT02585778|183261716|SUPERIORITY||Odds Ratio (OR)|52.9|||<|0.0001|TWO_SIDED|95.0|16.6|168.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||168.3|16.6|<0.0001
91685563|NCT02585778|183261717|SUPERIORITY||Odds Ratio (OR)|33.2|||<|0.0001|TWO_SIDED|95.0|8.0|137.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||137.4|8.0|<0.0001
91685564|NCT02585778|183261717|SUPERIORITY||Odds Ratio (OR)|27.1|||<|0.0001|TWO_SIDED|95.0|14.2|51.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||51.5|14.2|<0.0001
91685565|NCT02585778|183261718|SUPERIORITY||Odds Ratio (OR)|55.5||||0.0002|TWO_SIDED|95.0|6.5|473.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||473.7|6.5|0.0002
91685566|NCT02585778|183261718|SUPERIORITY||Odds Ratio (OR)|103.3|||<|0.0001|TWO_SIDED|95.0|24.6|433.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||433.1|24.6|<0.0001
91685567|NCT02585778|183261719|SUPERIORITY||Adjusted Mean Difference|-18.7||||0.0039|TWO_SIDED|95.0|-31.4|-6.0||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-6.0|-31.4|0.0039
91685568|NCT02585778|183261719|SUPERIORITY||Adjusted Mean Difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-23.7|-13.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-13.2|-23.7|<0.0001
91685569|NCT02585778|183261720|SUPERIORITY||LS Mean Difference|3.9||||0.3434|TWO_SIDED|95.0|-4.2|12.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||12.0|-4.2|0.3434
91685570|NCT02585778|183261720|SUPERIORITY||LS Mean Difference|4.4||||0.01|TWO_SIDED|95.0|1.1|7.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||7.7|1.1|0.0100
91685571|NCT02585778|183261721|SUPERIORITY||Adjusted Mean Difference|-5.7||||0.0902|TWO_SIDED|95.0|-12.3|0.9||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||0.9|-12.3|0.0902
91685572|NCT05246670|183261735|SUPERIORITY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-1.33|5.74||||||||5.74|-1.33|
91685573|NCT05246670|183261735|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-5.23|5.41||||||||5.41|-5.23|
91685574|NCT05246670|183261735|SUPERIORITY||Mean Difference (Final Values)|2.11|||||TWO_SIDED|95.0|-2.87|7.09||||||||7.09|-2.87|
91685575|NCT05124691|183261798|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
91487443|NCT01453725|182847409|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney Test|||||||<0.0001
91487444|NCT03755791|182847424|OTHER||Hazard Ratio (HR)|0.63||||0.0012|TWO_SIDED|99.0|0.44|0.91|||Log Rank|||||0.91|0.44|0.0012
91526969|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.7061|TWO_SIDED|95.0|-2.0|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 6 SCCAI score||3.0|-2.0|0.7061
91685576|NCT05124691|183261798|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
91685577|NCT05124691|183261798|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
91685578|NCT05124691|183261801|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||<0.0001
91685579|NCT05124691|183261801|SUPERIORITY||||||=|0.0007|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||=0.0007
91685580|NCT05124691|183261804|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
91685581|NCT05124691|183261804|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91685582|NCT05124691|183261804|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91685583|NCT01890434|183261825|SUPERIORITY||Sensitivity Difference|16.7||||9e-05|ONE_SIDED|95.0|9.3||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||9.3|0.00009
91685584|NCT01890434|183261825|SUPERIORITY||Sensitivity Difference|26.0|||<|0.0001|ONE_SIDED|95.0|18.2||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||18.2|<0.0001
91685585|NCT01890434|183261825|SUPERIORITY||Sensitivity Difference|32.0|||<|0.0001|ONE_SIDED|95.0|24.5||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||24.5|<0.0001
91685586|NCT01890434|183261826|SUPERIORITY||Sensitivity Difference|21.0||||5e-05|ONE_SIDED|95.0|12.1||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||12.1|0.00005
91685587|NCT01890434|183261826|SUPERIORITY||Sensitivity Difference|36.2|||<|0.0001|ONE_SIDED|95.0|26.3||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||26.3|<0.0001
91685588|NCT01890434|183261826|SUPERIORITY||Sensitivity Difference|41.0|||<|0.0001|ONE_SIDED|95.0|31.8||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||31.8|<0.0001
91685589|NCT01890434|183261831|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|95.0|12.9|28.4|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.||28.4|12.9|<0.0001
91685590|NCT01890434|183261831|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|90.0|14.2|27.2|||McNemar|McNemar 2-sided test at alpha level of 10%||||27.2|14.2|<0.0001
91685591|NCT01890434|183261833|NON_INFERIORITY|A non-inferiority margin was set as 15%|Sensitivity Difference|5.7||||0.2733|TWO_SIDED|95.0|-5.4|14.9|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.||14.9|-5.4|0.2733
91685592|NCT01890434|183261833|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Sensitivity Difference|0.0||||1|TWO_SIDED|95.0|-8.6|7.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.||7.2|-8.6|1.0000
91685593|NCT01890434|183261835|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|11.1||||0.001|TWO_SIDED|95.0|4.1|17.0|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.||17.0|4.1|0.0010
91685594|NCT01890434|183261835|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|7.8||||0.0094|TWO_SIDED|95.0|1.6|13.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.||13.2|1.6|0.0094
91685595|NCT00428116|183261848|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||WAZ-score comparison at 18 months||||0.15
91685596|NCT00428116|183261848|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||HAZ score at 18 months||||0.45
91685597|NCT00428116|183261849|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||log rank or Cox regression|incidence with Cox regression utilized Anderson-Gill method to handle recurrent events||SAEs||||0.39
91685598|NCT00428116|183261849|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Cox regression Anderson Gill|||Pneumonia||||0.60
91685599|NCT00428116|183261849|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Regression, Cox|||Pneumonia||||0.60
91685600|NCT00428116|183261849|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Regression, Cox|||Diarrhea||||0.77
91487445|NCT03755791|182847425|OTHER||Hazard Ratio (HR)|0.99||||0.9056|TWO_SIDED|96.0|0.78|1.24|||Log Rank|||||1.24|0.78|0.9056
91487446|NCT01254292|182847462|SUPERIORITY_OR_OTHER||single proportion|82.1|||||TWO_SIDED|95.0|77.1|86.5|||||Clopper Pearson Confidence Interval|||86.5|77.1|
91487447|NCT01254292|182847462|SUPERIORITY_OR_OTHER||single proportion|81.9|||||TWO_SIDED|95.0|76.7|86.4|||||Clopper Pearson Confidence Interval|||86.4|76.7|
91487448|NCT02083081|182847494|SUPERIORITY|||||||0.38|||||||generalized estimating equations (GEE)|||||||0.38
91685601|NCT00428116|183261849|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Death||||0.29
91526970|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8549|TWO_SIDED|95.0|-2.7|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 6 SCCAI score||2.3|-2.7|0.8549
91685602|NCT01044264|183261857|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|BE of the test to reference in the per protocol population|Wilcoxon Rank Sum Test|100.0|||||TWO_SIDED|90.0|92.47|113.54|||Wilcoxon Rank Sum Test|||||113.54|92.47|
91685603|NCT02257385|183261867|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis:the difference between the trt means (umeclidinium/vilanterol minus indacaterol + tiotropium bromide) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium/vilanterol may be deemed statistically non-inferior to indacaterol plus tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, statistical superiority would have been established.|Least Squares Mean Difference|0.001||||0.964|TWO_SIDED|95.0|-0.029|0.03|||Mixed Models Analysis|||||0.030|-0.029|0.964
91685604|NCT02257385|183261868|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.023||||0.145|TWO_SIDED|95.0|-0.054|0.008|||Mixed Models Analysis|||||0.008|-0.054|0.145
91487449|NCT02083081|182847495|SUPERIORITY|||||||0.45|||||||generalized estimating equations (GEE)|||||||0.45
91685605|NCT05147324|183261878|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
91685606|NCT05147324|183261879|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
91685607|NCT05147324|183261887|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91685608|NCT02714426|183261888|OTHER|||||||0.024||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,33) = 5.57, p = .024, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).||||.024
91685609|NCT02714426|183261889|OTHER|||||||0.333||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.96, p = .333, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.333
91685610|NCT02714426|183261891|OTHER|||||||0.001||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-8) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31.069) = 15.046, p = .001, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.001
91685611|NCT02714426|183261892|OTHER|||||||0.448||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.589, p = .0.448, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.448
91685612|NCT02714426|183261893|OTHER|||||||0.439||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31) = 0.616, p = 0.439, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.439
91685613|NCT01727726|183261894|OTHER||Mean Difference (Final Values)|-1.48||||0.0078|TWO_SIDED|95.0|-2.56|-0.39|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||-0.39|-2.56|0.0078
91487450|NCT02083081|182847496|SUPERIORITY|||||||0.96|||||||generalized estimating equations (GEE)|||||||0.96
91487451|NCT03109847|182847512|OTHER||Mean Difference (Net)|0.52||||0.404|TWO_SIDED|95.0|-1.26|2.29|||t-test, 2 sided|||||2.29|-1.26|0.404
91487452|NCT02927262|182847528|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.163|TWO_SIDED|95.0|0.407|1.336|||Log Rank||HR \& 95% CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors:age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.336|0.407|0.163
91487453|NCT02927262|182847529|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.627||95.0|0.54|2.364|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||2.364|0.540|0.627
91487454|NCT02927262|182847530|SUPERIORITY||Hazard Ratio (HR)|0.862||||0.296|TWO_SIDED|95.0|0.51|1.455|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.455|0.510|0.296
91685614|NCT01727726|183261894|OTHER||Mean Difference (Final Values)|-0.3||||0.6642|TWO_SIDED|95.0|-1.63|1.04|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||1.04|-1.63|0.6642
91685615|NCT01727726|183261895|OTHER||Mean Difference (Final Values)|-0.23||||0.1334|TWO_SIDED|95.0|-0.52|0.07|||MMRM|Mixed-model repeated measures (MMRM)||||0.07|-0.52|0.1334
91685616|NCT01727726|183261895|OTHER||Mean Difference (Final Values)|0.42||||0.0237|TWO_SIDED|95.0|0.06|0.78|||MMRM|Mixed-model repeated measures (MMRM)||||0.78|0.06|0.0237
91685617|NCT01727726|183261896|OTHER||Mean Difference (Final Values)|-1.53||||0.0001|TWO_SIDED|95.0|-2.29|-0.76|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 2||-0.76|-2.29|0.0001
91685618|NCT01727726|183261896|OTHER||Mean Difference (Final Values)|-1.22||||0.0103|TWO_SIDED|95.0|-2.15|-0.29|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 2||-0.29|-2.15|0.0103
91685619|NCT01727726|183261896|OTHER||Mean Difference (Final Values)|-1.17||||0.0185|TWO_SIDED|95.0|-2.15|-0.2|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 4||-0.20|-2.15|0.0185
91685620|NCT01727726|183261896|OTHER||Mean Difference (Final Values)|-0.08||||0.8949|TWO_SIDED|95.0|-1.27|1.11|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 4||1.11|-1.27|0.8949
91685621|NCT01727726|183261897|OTHER||Mean Difference (Final Values)|-0.15||||0.035|TWO_SIDED|95.0|-0.29|-0.01|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||-0.01|-0.29|0.0350
91685622|NCT01727726|183261897|OTHER||Mean Difference (Final Values)|-0.05||||0.5601|TWO_SIDED|95.0|-0.22|0.12|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||0.12|-0.22|0.5601
91685623|NCT01727726|183261897|OTHER||Mean Difference (Final Values)|-0.19||||0.0146|TWO_SIDED|95.0|-0.35|-0.04|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||-0.04|-0.35|0.0146
91685624|NCT01727726|183261897|OTHER||Mean Difference (Final Values)|-0.04||||0.7127|TWO_SIDED|95.0|-0.23|0.15|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||0.15|-0.23|0.7127
91685625|NCT01727726|183261898|OTHER||Ratio of response rate|1.49||||0.2242|TWO_SIDED|95.0|0.78|2.84|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.84|0.78|0.2242
91685626|NCT01727726|183261898|OTHER||Ratio of Response Rate|1.26||||0.5998|TWO_SIDED|95.0|0.53|2.98|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.98|0.53|0.5998
91685627|NCT01727726|183261899|OTHER||Ratio of Response Rate|1.52||||0.3321|TWO_SIDED|95.0|0.66|3.49|||Cochran-Mantel-Haenszel|||Phase B Week 6||3.49|0.66|0.3321
91685628|NCT01727726|183261899|OTHER||Ratio of Response Rate|0.51||||0.3917|TWO_SIDED|95.0|0.11|2.46|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.46|0.11|0.3917
91685629|NCT01727726|183261900|OTHER||Ratio of Response Rate|1.35||||0.0032|TWO_SIDED|95.0|1.1|1.66|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.66|1.10|0.0032
91685630|NCT01727726|183261900|OTHER||Ratio of Response Rate|1.24||||0.0898|TWO_SIDED|95.0|0.98|1.59|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.59|0.98|0.0898
91685631|NCT01727726|183261902|OTHER||Mean Difference (Final Values)|0.16||||0.448|TWO_SIDED|95.0|-0.25|0.56|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||0.56|-0.25|0.4480
91685632|NCT01727726|183261902|OTHER||Mean Difference (Final Values)|0.52||||0.038|TWO_SIDED|95.0|0.03|1.02|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||1.02|0.03|0.0380
91685633|NCT01727726|183261902|OTHER||Mean Difference (Final Values)|-0.34||||0.0436|TWO_SIDED|95.0|-0.66|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||-0.01|-0.66|0.0436
91685634|NCT01727726|183261902|OTHER||Mean Difference (Final Values)|0.43||||0.035|TWO_SIDED|95.0|0.03|0.84|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||0.84|0.03|0.0350
91685635|NCT01727726|183261902|OTHER||Mean Difference (Final Values)|-0.35||||0.0424|TWO_SIDED|95.0|-0.69|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||-0.01|-0.69|0.0424
91685636|NCT01727726|183261902|OTHER||Mean Difference (Final Values)|0.33||||0.123|TWO_SIDED|95.0|-0.09|0.75|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||0.75|-0.09|0.1230
91685637|NCT00086281|183261920|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA on ranks|||||||0.009
91685638|NCT00086281|183261920|SUPERIORITY_OR_OTHER|||||||0.0244||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0244
91685639|NCT00086281|183261920|SUPERIORITY_OR_OTHER|||||||0.0119||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0119
91685640|NCT00086281|183261920|SUPERIORITY_OR_OTHER|||||||0.5055||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.5055
91685641|NCT00086281|183261920|SUPERIORITY_OR_OTHER|||||||0.3132||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.3132
91685642|NCT02391987|183261924|SUPERIORITY|||||||0.73|||||||Cochran-Mantel-Haenszel|||||||0.73
91685643|NCT02391987|183261925|SUPERIORITY|||||||0.98|||||||Cochran-Mantel-Haenszel|||||||0.98
91685644|NCT02391987|183261926|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
91685645|NCT01595386|183261960|NON_INFERIORITY_OR_EQUIVALENCE|Study sample size was powered to detect a 60% difference in LCOS between groups at α 0.05 and β 0.70, assuming the prevalence of LCOS after neonatal bypass of 65% (based on retrospective data of patients who died, required rescue steroids, ECMO, or epinephrine \> 0.1 μg/kg/min).||||||0.049|TWO_SIDED|||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||||||0.049
91685646|NCT01595386|183261961|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.44|TWO_SIDED|95.0|||||Chi-squared|||||||0.44
91685647|NCT01595386|183261962|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.62|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.62
91685648|NCT01595386|183261963|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91685649|NCT01595386|183261963|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||interleukin-6 at 12, 24, and 48 hour. A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
91685650|NCT01595386|183261963|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||TNF-alpha at 12, 24, and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
91685651|NCT01595386|183261963|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin1-beta at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
91526971|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6533|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 6 SCCAI score||3.1|-2.0|0.6533
91685652|NCT01595386|183261963|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin-8 at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
91685653|NCT01595386|183261963|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.03|TWO_SIDED|95.0||||IL-10 at 4 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.03
91685654|NCT01595386|183261964|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91685655|NCT01595386|183261965|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
91685656|NCT01595386|183261966|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91685657|NCT01595386|183261967|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.7|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7
91685658|NCT01595386|183261968|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
91685659|NCT01595386|183261969|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.23|TWO_SIDED|95.0|||||Fisher Exact|||||||0.23
91685660|NCT01595386|183261970|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
91685661|NCT01595386|183261970|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.001|TWO_SIDED|95.0||||post-operative cortisol.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||<0.001
91685662|NCT01595386|183261970|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.004|TWO_SIDED|95.0||||Adrenal Insufficiency after bypass.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.004
91685663|NCT01595386|183261970|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.02|TWO_SIDED|95.0||||Development of Low cardiac output syndrome in subjects with Adrenal Insufficiency.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.02
91685664|NCT04784533|183262017|SUPERIORITY||Difference in percentages|16.2|||||TWO_SIDED|95.0|5.5|26.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||26.8|5.5|
91685665|NCT04784533|183262017|SUPERIORITY||Difference in percentages|12.1|||||TWO_SIDED|95.0|1.3|22.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.9|1.3|
91685666|NCT04784533|183262017|SUPERIORITY||Difference in percentages|26.4|||||TWO_SIDED|95.0|15.4|37.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||37.5|15.4|
91526972|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4378|TWO_SIDED|95.0|-3.1|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 6 SCCAI score||1.4|-3.1|0.4378
91685667|NCT04784533|183262017|SUPERIORITY||Difference in percentages|19.9|||||TWO_SIDED|95.0|8.5|31.3|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.3|8.5|
91685668|NCT04784533|183262018|SUPERIORITY||Difference in percentages|0.6|||||TWO_SIDED|95.0|-2.7|3.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 8||3.9|-2.7|
91685669|NCT04784533|183262018|SUPERIORITY||Difference in percentages|10.6|||||TWO_SIDED|95.0|3.3|17.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||17.9|3.3|
91685670|NCT04784533|183262018|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|5.3|22.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.8|5.3|
91685671|NCT04784533|183262018|SUPERIORITY||Difference in percentages|19.4|||||TWO_SIDED|95.0|9.2|29.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||29.5|9.2|
91685672|NCT04784533|183262018|SUPERIORITY||Difference in percentages|20.8|||||TWO_SIDED|95.0|9.8|31.7|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.7|9.8|
91685673|NCT04784533|183262019|SUPERIORITY||Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-2.8|1.8|||||LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.|Week 4||1.8|-2.8|
91685674|NCT04784533|183262019|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-11.9|-2.7|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 8||-2.7|-11.9|
91685675|NCT04784533|183262019|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-19.3|-5.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-5.5|-19.3|
91685676|NCT04784533|183262019|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-22.2|-6.9|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-6.9|-22.2|
91487455|NCT02927262|182847531|SUPERIORITY|||||||0.97||||||2-sided P-value from analysis of covariance (ANCOVA) including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 3||||0.970
91487456|NCT02927262|182847531|SUPERIORITY|||||||0.415||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 6||||0.415
91487457|NCT02927262|182847531|SUPERIORITY|||||||0.271||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 12||||0.271
91526973|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.5917|TWO_SIDED|95.0|-2.2|1.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 1 SCCAI score||1.3|-2.2|0.5917
91685677|NCT04784533|183262019|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-23.7|-7.2|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-7.2|-23.7|
91719565|NCT01420536|183331993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.399
91685678|NCT04784533|183262019|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.36|||TWO_SIDED|95.0|-24.0|-6.8|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-6.8|-24.0|
91685679|NCT04784533|183262020|SUPERIORITY||Difference in percentages|20.9|||||TWO_SIDED|95.0|9.9|31.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||31.8|9.9|
91719566|NCT01420536|183331994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.550
91719567|NCT01420536|183331995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.609
91719568|NCT01420536|183331996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.600
91719569|NCT01420536|183331997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.611
91719570|NCT01420536|183331998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.044
91487458|NCT02927262|182847531|SUPERIORITY|||||||0.179||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 24/EoT||||0.179
91487459|NCT02913612|182847534|SUPERIORITY||Odds Ratio, log|2.65||||0.0205|TWO_SIDED|95.0|1.12|6.26|||Fisher Exact|||||6.26|1.12|0.0205
91487460|NCT02913612|182847534|SUPERIORITY||Odds Ratio, log|2.16||||0.0619|TWO_SIDED|95.0|0.91|5.14|||Fisher Exact|||||5.14|0.91|0.0619
91487461|NCT02913612|182847534|SUPERIORITY||Odds Ratio, log|1.23||||0.6281|TWO_SIDED|95.0|0.53|2.82|||Fisher Exact|||||2.82|0.53|0.6281
91487462|NCT04402060|182847552|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.82|TWO_SIDED|90.0|0.63|1.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% confidence interval (CI) was based on the Wald method.||1.51|0.63|0.82
91487463|NCT04402060|182847553|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.36|TWO_SIDED|90.0|0.77|3.4|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||3.40|0.77|0.36
91487464|NCT04402060|182847555|SUPERIORITY||Hazard Ratio (HR)|0.09||||0.03|TWO_SIDED|90.0|0.01|0.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||0.51|0.01|0.03
91487465|NCT04402060|182847556|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.93|TWO_SIDED|90.0|0.69|1.72|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||1.72|0.69|0.93
91526974|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.1764|TWO_SIDED|95.0|-0.5|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 1 SCCAI score||2.9|-0.5|0.1764
91526975|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7914|TWO_SIDED|95.0|-1.5|2.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 1 SCCAI score||2.0|-1.5|0.7914
91526976|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3578|TWO_SIDED|95.0|-0.9|2.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 1 SCCAI score||2.5|-0.9|0.3578
91526977|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.3247|TWO_SIDED|95.0|-1.0|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 2 SCCAI score||2.9|-1.0|0.3247
91487466|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Kruskal-Wallis|||For Vancomycin, all patients||||0.92
91487467|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, organisms not requiring vancomycin.||||0.032
91487468|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin-susceptible enterococci||||0.037
91685680|NCT04784533|183262020|SUPERIORITY||Difference in percentages|13.8|||||TWO_SIDED|95.0|2.5|25.2|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||25.2|2.5|
91685681|NCT04784533|183262020|SUPERIORITY||Difference in percentages|15.6|||||TWO_SIDED|95.0|4.1|27.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||27.0|4.1|
91685682|NCT04784533|183262020|SUPERIORITY||Difference in percentages|14.4|||||TWO_SIDED|95.0|2.9|25.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||25.9|2.9|
91685683|NCT04784533|183262021|SUPERIORITY||Difference in percentages|22.9|||||TWO_SIDED|95.0|11.9|34.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||34.0|11.9|
91685684|NCT04784533|183262021|SUPERIORITY||Difference in percentages|21.9|||||TWO_SIDED|95.0|10.7|33.1|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||33.1|10.7|
91685685|NCT04784533|183262021|SUPERIORITY||Difference in percentages|22.6|||||TWO_SIDED|95.0|11.2|33.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||33.9|11.2|
91685686|NCT04784533|183262021|SUPERIORITY||Difference in percentages|19.5|||||TWO_SIDED|95.0|8.1|31.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.0|8.1|
91685687|NCT04784533|183262022|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.9|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-0.3|-0.9|
91685688|NCT04784533|183262022|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.1|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-0.4|-1.1|
91685689|NCT04784533|183262022|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-0.4|-1.2|
91685690|NCT04784533|183262022|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.2|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-0.3|-1.2|
91685691|NCT04784533|183262023|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 12||-0.1|-0.7|
91685692|NCT04784533|183262023|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.0|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 16||-0.3|-1.0|
91685693|NCT04784533|183262023|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.2|-0.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 20||-0.5|-1.2|
91487469|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, methicillin-susceptible Staphylococcus aureus.||||0.2
91685694|NCT04784533|183262023|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 24||-0.4|-1.2|
91685695|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 12||-0.2|-0.7|
91685696|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 16||-0.2|-0.7|
91685697|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 20||-0.3|-0.8|
91685698|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 24||-0.2|-0.8|
91685699|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 12||-0.3|-0.8|
91685700|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.7|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 16||-0.3|-0.7|
91685701|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 20||-0.3|-0.8|
91685702|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 24||-0.3|-0.8|
91685703|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 12||-0.2|-0.8|
91685704|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 16||-0.1|-0.6|
91685705|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 20||-0.1|-0.7|
91685706|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 24||-0.2|-0.7|
91685707|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 12||-0.2|-0.7|
91685708|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 16||-0.2|-0.7|
91685709|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 20||-0.2|-0.7|
91487470|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||For nafcillin, oxacillin, or cefazolin.||||0.035
91487471|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||For piperacillin-tazobactam.||||0.012
91487472|NCT01898208|182847592|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Kruskal-Wallis|||For cefepime.||||0.56
91487473|NCT01898208|182847593|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the 3 groups.||||0.55
91487474|NCT01898208|182847594|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate de-escalation comparing the 3 groups.||||<0.0001
91526978|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1153|TWO_SIDED|95.0|-0.4|3.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 2 SCCAI score||3.4|-0.4|0.1153
91685710|NCT04784533|183262024|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 24||-0.3|-0.8|
91685711|NCT02682927|183262045|SUPERIORITY||Percentage difference from Placebo|62.29|||||TWO_SIDED|95.0|47.72|72.8|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||72.80|47.72|
91685712|NCT02682927|183262045|SUPERIORITY||Percentage difference from Placebo|64.75|||||TWO_SIDED|95.0|51.85|74.19|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||74.19|51.85|
91685713|NCT02682927|183262046|SUPERIORITY||Percentage difference from Placebo|32.43|||||TWO_SIDED|95.0|6.19|51.33|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||51.33|6.19|
91685714|NCT02682927|183262046|SUPERIORITY||Percentage difference from Placebo|49.88|||||TWO_SIDED|95.0|31.31|63.43|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||63.43|31.31|
91685715|NCT02682927|183262048|SUPERIORITY||Odds Ratio (OR)|4.773||||0.009|TWO_SIDED|95.0|1.475|15.45|||Regression, Logistic|||||15.450|1.475|0.009
91685716|NCT02682927|183262048|SUPERIORITY||Odds Ratio (OR)|14.96|||<|0.001|TWO_SIDED|95.0|4.484|49.915|||Regression, Logistic|||||49.915|4.484|<0.001
91685717|NCT02682927|183262048|SUPERIORITY||Odds Ratio (OR)|13.4||||0.0001|TWO_SIDED|95.0|3.6|49.8|||Regression, Logistic|||||49.8|3.6|0.0001
91685718|NCT02682927|183262048|SUPERIORITY||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|12.9|220.5|||Regression, Logistic|||||220.5|12.9|<0.0001
91685719|NCT02682927|183262051|SUPERIORITY|||||||0.035|||||||Wilcoxon rank sum test|||||||0.035
91685720|NCT02682927|183262051|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91685721|NCT02682927|183262051|SUPERIORITY||Comparing active with placebo|||||0.0002|||||||Wilcoxon rank sum test|||||||0.0002
91487475|NCT01898208|182847594|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate escalation comparing the 3 groups.||||0.04
91526979|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7995|TWO_SIDED|95.0|-1.7|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 2 SCCAI score||2.2|-1.7|0.7995
91685722|NCT02682927|183262051|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
91685723|NCT03462459|183262070|EQUIVALENCE|Proportional tests (Chi-squared) compared the episodes of C. difficile. Log-rank tests (Kaplan-Meier) were conducted to compare the non-recurrence proportions within the eight-week period. Multivariate Cox proportional hazard regression determined if treatment, age, and number of previous C. difficile episodes were predictors of recurrence.|See comments|-0.11||||0.22|TWO_SIDED|95.0|-35.1|8.0|||Chi-squared||Proportional tests compared episodes of C. difficile recurrence in eight weeks (vancomycin vs. placebo) using Chi-squared test. Log-rank tests compared the non-recurrence proportions within 8 weeks with the Kaplan-Meier method.||"Statistical analyses are primarily reported for the population who were randomized in the study (as randomized). The secondary statistical analyses are reported for the population who completed all three visits (as completed treatment). Proportional tests were conducted to compare the episodes of C. difficile recurrence in eight weeks following the completion of the study intervention in patients receiving vancomycin versus placebo using the Chi-squared test. Log-rank tests were conducted to compare the non-recurrence proportions within the eight-week period in patients receiving vancomycin versus placebo with the Kaplan-Meier method. A nonparametric Wilcoxon rank sum test was used to compare distributions of the number of days to the first recurrence of CDI after starting oral vancomycin or placebo. The significance level was set to be ≤0.05. All statistical analyses were conducted in R statistical software (version 4.4.0; R Core Team, 2024)"|8.0|-35.1|0.22
91685724|NCT03462459|183262072|EQUIVALENCE|Proportional difference tests comparing the proportion of patients with VRE colonization at Visit 3, compared to baseline. Significance level was set to 0.10.||||||0.1|||||||Proportional difference test|||||||0.10
91685725|NCT03975491|183262090|SUPERIORITY||Mean Difference (Net)|20.9||||0.32|TWO_SIDED|95.0|-17.1|76.2|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||76.2|-17.1|0.32
91685726|NCT03975491|183262091|SUPERIORITY||Mean Difference (Net)|11.4||||0.25|TWO_SIDED|95.0|-7.5|34.0|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||34.0|-7.5|0.25
91685727|NCT03975491|183262092|SUPERIORITY||Mean Difference (Net)|-3.6||||0.52|TWO_SIDED|95.0|-13.7|7.7|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||7.7|-13.7|0.52
91685728|NCT03975491|183262093|SUPERIORITY||Mean Difference (Net)|0.59||||0.21|TWO_SIDED|95.0|-0.33|1.51|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||1.51|-0.33|0.21
91487476|NCT01898208|182847595|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Chi-squared|||This analysis compares the 3 groups.||||0.015
91487477|NCT01898208|182847596|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the FilmArray test to control arm.||||<0.0001
91487478|NCT01898208|182847596|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares FilmArray plus antimicrobial stewardship to the control arm.||||<0.0001
91487479|NCT01898208|182847597|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Kruskal-Wallis|||This analysis is to compare the three groups.||||0.79
91719571|NCT01420536|183331999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.677
91719572|NCT01420536|183332000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.885||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.885
91719573|NCT03191552|183332016|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91719574|NCT03191552|183332017|SUPERIORITY|||||||0.027||||||Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.027
91719575|NCT03191552|183332018|SUPERIORITY|||||||0.008||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.008
91719576|NCT03191552|183332019|SUPERIORITY|Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.||||||0.004||||||Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.004
91719577|NCT03191552|183332020|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||||||0.837
91719578|NCT03191552|183332021|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||0.570
91487480|NCT01898208|182847598|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Kruskal-Wallis|||||||0.90
91685729|NCT03975491|183262095|SUPERIORITY||Mean Difference (Net)|0.0005||||0.73|TWO_SIDED|95.0|-0.0024|0.0034|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||0.0034|-0.0024|0.73
91719579|NCT03191552|183332022|SUPERIORITY|||||||0.334|||||||Kruskal-Wallis|||||||0.334
91719580|NCT03191552|183332023|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91487481|NCT01898208|182847599|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||This analysis is a comparison of the 3 groups.||||0.62
91685730|NCT03922529|183262105|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.543|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5430
91685731|NCT03922529|183262106|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7625|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7625
91685732|NCT03922529|183262107|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.8842|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8842
91685733|NCT03922529|183262108|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.4086|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4086
91719581|NCT03191552|183332024|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
91719582|NCT03191552|183332025|SUPERIORITY|||||||0.889|||||||Kruskal-Wallis|||||||0.889
91719583|NCT03191552|183332026|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
91719584|NCT03191552|183332027|SUPERIORITY||||||,|0||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0,001
91487482|NCT01898208|182847600|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the three groups.||||0.60
91487483|NCT01898208|182847601|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for all-cause mortality.||||0.74
91487484|NCT01898208|182847601|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for attributable mortality.||||0.42
91685734|NCT03922529|183262109|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3841|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.3841
91719585|NCT03191552|183332028|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.14
91719586|NCT03191552|183332029|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
91719587|NCT03191552|183332030|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
91719588|NCT03191552|183332031|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
91719589|NCT03191552|183332032|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91719590|NCT05352763|183332111|OTHER|No statistical analysis performed|||||||||||||||||The classical summary of count and percentages will be provided for basic safety tabulations and dispositions as appropriate. All data will be presented in by-subject data listings. No inferential statistics will be produced.|||
91719591|NCT02555254|183332123|SUPERIORITY|||||||0.55|||||||Wilcoxon's rank test|||||||0.55
91719592|NCT04780659|183332127|OTHER||||||<|0.05||||||The reported p-value was calculated.|Fisher Exact|||||||< 0.05
91719593|NCT04780659|183332130|OTHER||||||<|0.05|||||||Chi-squared|||||||< 0.05
91719594|NCT04780659|183332131|OTHER||||||<|0.05|||||||Chi-squared|||||||< 0.05
91685735|NCT03922529|183262110|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1393|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|||The adjusted difference from a model may not necessarily match the raw difference between groups.|||0.1393
91685736|NCT03922529|183262111|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|12.3||0.9257|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9257
91685737|NCT03922529|183262112|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|11.8||0.6588|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6588
91685738|NCT03922529|183262113|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|13.0||0.992|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9920
91685739|NCT03922529|183262114|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9504|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9504
91685740|NCT03922529|183262115|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.6228|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6228
91685741|NCT03922529|183262116|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7966|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7966
91685742|NCT03922529|183262117|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5071|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5071
91685743|NCT03922529|183262118|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5553|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5553
91685744|NCT03922529|183262119|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1194|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1194
91685745|NCT03922529|183262120|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9012|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9012
91685746|NCT03922529|183262121|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4279|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4279
91685747|NCT03922529|183262122|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.8||0.1932|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1932
91685748|NCT03922529|183262123|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.2723|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2723
91722505|NCT06001021|183337813|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|8.26|STANDARD_DEVIATION|3.96||0|TWO_SIDED|90.0|7.52|9.01||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Social Domain of Quality of Life||9.01|7.52|0.000
91487485|NCT01898208|182847602|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Fisher Exact|||This analysis is a comparison across all three groups.||||0.82
91487486|NCT01898208|182847604|SUPERIORITY_OR_OTHER|||||||0.7789|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for total hospitalization costs.||||0.7789
91685749|NCT03922529|183262124|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8951|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8951
91685750|NCT03922529|183262125|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.2||0.2574|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2574
91685751|NCT03922529|183262126|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8307|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8307
91487487|NCT01898208|182847604|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for laboratory test cost.||||0.0006
91487488|NCT01898208|182847604|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for antimicrobials costs.||||0.6540
91487489|NCT01033851|182847615|SUPERIORITY_OR_OTHER|||||||0.0366||95.0|||||ANOVA|||A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p\<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).||||0.0366
91685752|NCT03922529|183262127|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.614|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6140
91685753|NCT03922529|183262128|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.0||0.7327|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7327
91685754|NCT03922529|183262129|SUPERIORITY|||||||0.7651|||||||Wilcoxon rank sum|||||||0.7651
91685755|NCT03922529|183262130|SUPERIORITY||Incident Rate Ratio|1.15||||0.3974|TWO_SIDED|95.0|0.83|1.59|||Negative binomial regression models|||||1.59|0.83|0.3974
91685756|NCT03922529|183262131|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.5||0.2727|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2727
91685757|NCT03922529|183262132|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.5||0.4269|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4269
91685758|NCT03922529|183262133|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.6||0.4354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4354
91685759|NCT03922529|183262134|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8695|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8695
91685760|NCT03922529|183262135|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.7075|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7075
91685761|NCT03922529|183262136|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8936|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8936
91685762|NCT03922529|183262137|SUPERIORITY|||||||0.2794|||||||Chi-squared|||||||0.2794
91685763|NCT03922529|183262138|SUPERIORITY|||||||0.6177|||||||Chi-squared|||||||0.6177
91685764|NCT03922529|183262139|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||0.1440
91685765|NCT03922529|183262140|SUPERIORITY|||||||0.1122|||||||Chi-squared|||||||0.1122
91685766|NCT03922529|183262141|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9653|TWO_SIDED|95.0|0.63|1.62|||Regression, Logistic|||||1.62|0.63|0.9653
91685767|NCT02731638|183262142|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.65|5.23|||Regression, Logistic|Bias-corrected logistic regression, accounting for baseline culture status||||5.23|0.65|0.26
91685768|NCT02731638|183262143|SUPERIORITY||Coefficient|1.6||||0.25|TWO_SIDED|95.0|-1.2|4.4|||Regression, Linear||Positive coefficients of the logMAR value indicated worsened visual acuity|||4.4|-1.2|0.25
91685769|NCT02731638|183262143|SUPERIORITY||Coefficient|0.5||||0.75|TWO_SIDED|95.0|-2.6|3.6|||Regression, Linear||Positive coefficients of the logMAR value indicate worsened visual acuity|||3.6|-2.6|0.75
91685770|NCT02454608|183262152|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91685771|NCT02454608|183262153|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91685772|NCT02454608|183262154|SUPERIORITY_OR_OTHER|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91685773|NCT02454608|183262155|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91685774|NCT02454608|183262156|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
91685775|NCT02454608|183262157|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
91685776|NCT02454608|183262158|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.7
91685777|NCT02462291|183262169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||1|TWO_SIDED|95.0|-7.9|5.4|||ANOVA|||Baseline||5.4|-7.9|1
91685778|NCT02462291|183262169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.3|||<|0.01|TWO_SIDED|95.0|26.4|40.2|||ANOVA|||After the treatment||40.2|26.4|<0.01
91685779|NCT02462291|183262169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|||<|0.01|TWO_SIDED|95.0|-38.2|-24.8|||ANOVA|||PRE Vs POST||-24.8|-38.2|<0.01
91685780|NCT02462291|183262169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||1|TWO_SIDED|95.0|-3.7|9.9|||ANOVA|||PRE Vs POST||9.9|-3.7|1
91685781|NCT02462291|183262170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||1|TWO_SIDED|95.0|-0.8|0.5|||ANOVA|||Baseline||0.5|-0.8|1
91685782|NCT02462291|183262170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94|||<|0.01|TWO_SIDED|95.0|-2.6|-1.2|||ANOVA|||After the treatment||-1.2|-2.6|<0.01
91487490|NCT02728596|182847625|SUPERIORITY||Odds Ratio (OR)|0.44||||0.21|TWO_SIDED|95.0|0.12|1.57|||Regression, Logistic|Adjusted for age group, comorbidity, race, and Hispanic ethnicity.||PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||1.57|0.12|0.21
91685783|NCT02462291|183262170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.01|TWO_SIDED|95.0|0.28|1.61|||ANOVA|||PRE Vs POST||1.61|0.28|<0.01
91685784|NCT02462291|183262170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.01|TWO_SIDED|95.0|-1.52|-0.17|||ANOVA|||PRE Vs POST||-0.17|-1.52|<0.01
91685785|NCT02462291|183262171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||=|0.84|TWO_SIDED|95.0|-3.6|2.1|||ANOVA|||Baseline||2.1|-3.6|= 0.84
91685786|NCT02462291|183262171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.9|TWO_SIDED|95.0|-4.3|1.7|||ANOVA|||After the treatment||1.7|-4.3|= 0.9
91685787|NCT02462291|183262171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.88|TWO_SIDED|95.0|-3.14|2.69|||ANOVA|||PRE Vs POST||2.69|-3.14|0.88
91685788|NCT02462291|183262171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.89|TWO_SIDED|95.0|-3.73|2.16|||ANOVA|||PRE Vs POST||2.16|-3.73|0.89
91685789|NCT02462291|183262172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.9|TWO_SIDED|95.0|-5.48|2.73|||ANOVA|||Baseline||2.73|-5.48|0.9
91685790|NCT02462291|183262172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.62||||0.59|TWO_SIDED|95.0|-1.6|6.9|||ANOVA|||After the treatment||6.90|-1.60|0.59
91685791|NCT02462291|183262172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.34|TWO_SIDED|95.0|-7.15|1.16|||ANOVA|||PRE Vs POST||1.16|-7.15|0.34
91685792|NCT02462291|183262172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.9|TWO_SIDED|95.0|-3.17|5.23|||ANOVA|||PRE Vs POST||5.23|-3.17|0.9
91487491|NCT02728596|182847625|SUPERIORITY||Odds Ratio (OR)|1.18||||0.74|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||3.20|0.44|0.74
91685793|NCT02462291|183262173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.83|TWO_SIDED|95.0|-1.41|2.14|||ANOVA|||Baseline||2.14|-1.41|0.83
91722506|NCT06001021|183337813|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|23.73|STANDARD_DEVIATION|11.07||0|TWO_SIDED|90.0|21.64|25.81||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||||25.81|21.64|0.000
91722507|NCT03112603|183337818|OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|1.86|4.8|||Cochran-Mantel-Haenszel|||||4.80|1.86|<0.0001
91487492|NCT02728596|182847625|SUPERIORITY||Odds Ratio (OR)|2.23||||0.17|TWO_SIDED|95.0|0.7|7.08|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||7.08|0.70|0.17
91685794|NCT02462291|183262173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69|||<|0.01|TWO_SIDED|95.0|0.84|4.53|||ANOVA|||After the treatment||4.53|0.84|<0.01
91685795|NCT02462291|183262173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.01|TWO_SIDED|95.0|-3.94|-0.34|||ANOVA|||PRE Vs POST||-0.34|-3.94|0.010
91685796|NCT02462291|183262173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.84|TWO_SIDED|95.0|-1.64|2.0|||ANOVA|||PRE Vs POST||2.00|-1.64|0.84
91685797|NCT02462291|183262174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.11|TWO_SIDED|95.0|-0.16|2.95|||ANOVA|||Baseline||2.95|-0.16|0.11
91685798|NCT02462291|183262174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.7|TWO_SIDED|95.0|-0.81|2.41|||ANOVA|||After the treatment||2.41|-0.81|0.7
91685799|NCT02462291|183262174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.88|TWO_SIDED|95.0|-1.17|1.98|||ANOVA|||PRE Vs POST||1.98|-1.17|0.88
91685800|NCT02462291|183262174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.95|TWO_SIDED|95.0|-1.78|1.39|||ANOVA|||PRE Vs POST||1.39|-1.78|0.95
91685801|NCT02462291|183262175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.95|TWO_SIDED|95.0|-0.67|0.4|||ANOVA|||Baseline||0.40|-0.67|0.95
91685802|NCT02462291|183262175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.23|TWO_SIDED|95.0|-0.12|0.99|||ANOVA|||After the treatment||0.99|-0.12|0.23
91685803|NCT02462291|183262175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-0.65|0.44|||ANOVA|||PRE Vs POST||0.44|-0.65|0.96
91685804|NCT02462291|183262175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.15|TWO_SIDED|95.0|-0.08|1.01|||ANOVA|||PRE Vs POST||1.01|-0.08|0.15
91685805|NCT02462291|183262176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.84|TWO_SIDED|95.0|-1.14|1.27|||ANOVA|||Baseline||1.27|-1.14|0.84
91685806|NCT02462291|183262176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.81|TWO_SIDED|95.0|-0.96|1.54|||ANOVA|||After the treatment||1.54|-0.96|0.81
91685807|NCT02462291|183262176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.86|TWO_SIDED|95.0|-1.71|0.74|||ANOVA|||PRE Vs POST||0.74|-1.71|0.86
91685808|NCT02462291|183262176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.75|TWO_SIDED|95.0|-1.49|0.97|||ANOVA|||PRE Vs POST||0.97|-1.49|0.75
91685809|NCT02462291|183262177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.94|TWO_SIDED|95.0|-74.4|44.9|||ANOVA|||Baseline||44.9|-74.4|0.94
91685810|NCT02462291|183262177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.36||||0.87|TWO_SIDED|95.0|-53.47|70.2|||ANOVA|||After the treatment||70.20|-53.47|0.87
91685811|NCT02462291|183262177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.78|TWO_SIDED|95.0|-90.19|30.78|||ANOVA|||PRE Vs POST||30.78|-90.19|0.78
91685812|NCT02462291|183262177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.84|TWO_SIDED|95.0|-67.7|54.5|||ANOVA|||PRE Vs POST||54.5|-67.7|0.84
91685813|NCT02462291|183262178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.74|TWO_SIDED|95.0|-3.73|4.56|||ANOVA|||Baseline||4.56|-3.73|0.74
91685814|NCT02462291|183262178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25||||0.82|TWO_SIDED|95.0|-5.54|3.04|||ANOVA|||After the treatment||3.04|-5.54|0.82
91685815|NCT02462291|183262178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.59|TWO_SIDED|95.0|-3.57|4.82|||ANOVA|||PRE Vs POST||4.82|-3.57|0.59
91487493|NCT02728596|182847625|SUPERIORITY||Odds Ratio (OR)|0.36||||0.094|TWO_SIDED|95.0|0.11|1.19|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||1.19|0.11|0.094
91487494|NCT02728596|182847626|SUPERIORITY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.75|2.95|||Regression, Logistic|Adjusted for age.||FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||2.95|0.75|0.26
91685816|NCT02462291|183262178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.69|TWO_SIDED|95.0|-5.28|3.19|||ANOVA|||PRE Vs POST||3.19|-5.28|0.69
91685817|NCT02462291|183262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.9|TWO_SIDED|95.0|-0.64|1.09|||ANOVA|||Baseline||1.09|-0.64|0.9
91685818|NCT02462291|183262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.01|TWO_SIDED|95.0|1.96|3.76|||ANOVA|||After the treatment||3.76|1.96|<0.01
91685819|NCT02462291|183262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|||<|0.01|TWO_SIDED|95.0|-3.8|-2.04|||ANOVA|||PRE Vs POST||-2.04|-3.80|<0.01
91685820|NCT02462291|183262179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.88|TWO_SIDED|95.0|-1.17|0.59|||ANOVA|||PRE Vs POST||0.59|-1.17|0.88
91685821|NCT02462291|183262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.83|TWO_SIDED|95.0|-0.72|0.37|||ANOVA|||Baseline||0.37|-0.72|0.83
91685822|NCT02462291|183262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.005|TWO_SIDED|95.0|0.15|1.29|||ANOVA|||After the treatment||1.29|0.15|0.005
91685823|NCT02462291|183262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.013|TWO_SIDED|95.0|-1.21|-0.09|||ANOVA|||PRE Vs POST||-0.09|-1.21|0.013
91487495|NCT02728596|182847626|SUPERIORITY||Odds Ratio (OR)|2.0||||0.51|TWO_SIDED|95.0|0.23|18.8|||Regression, Logistic|Adjusted for cancer type.||FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||18.80|0.23|0.51
91685824|NCT02462291|183262180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.87|TWO_SIDED|95.0|-0.31|0.81|||ANOVA|||PRE Vs POST||0.81|-0.31|0.87
91685825|NCT02462291|183262181|SUPERIORITY_OR_OTHER||Chi-squared value|0.542|||=|0.91|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.082; 3 degrees of freedom|||||= 0.910
91685826|NCT02462291|183262182|SUPERIORITY_OR_OTHER||Chi-squared value|17.73|||<|0.001|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.965; 3 degrees of freedom|||||<0.001
91685827|NCT02462291|183262183|SUPERIORITY_OR_OTHER||Chi-squared value|5.749||||0.124|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.488; 3 degrees of freedom|||||0.124
91685828|NCT02462291|183262184|SUPERIORITY_OR_OTHER||Chi-squared value|0.008||||1|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.050; 3 degrees of freedom|||||1
91685829|NCT02462291|183262185|SUPERIORITY_OR_OTHER||Chi-squared value|1.049||||0.789|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.116; 3 degrees of freedom|||||0.789
91685830|NCT01549405|183262193|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mann-Whitney U test|||||||0.002
91685831|NCT01549405|183262194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.1|STANDARD_DEVIATION|58.0||0|TWO_SIDED|95.0|52.98|132.4|||t-test, 2 sided|||||132.4|52.98|0.000
91685832|NCT02111603|183262218|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of on-treatment total fecal bile acid excretion with baseline total fecal bile acid excretion.||||0.012
91685833|NCT00976911|183262225|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|15.7|||||TWO_SIDED|95.0|6.5|24.8||||||||24.8|6.5|
91685834|NCT00976911|183262225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Pearson's chi-square|unstratified analysis||||||0.0010
91685835|NCT00976911|183262225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Cochran-Mantel-Haenszel|||||||0.0007
91685836|NCT00976911|183262226|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45||||0.0202|TWO_SIDED|95.0|0.225|0.9||Unstratified analysis|Log Rank||Hazard ratio was estimated by unstratified Cox regression model.|||0.900|0.225|0.0202
91685837|NCT00976911|183262226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0081|TWO_SIDED||||||Peto-Peto-Prentice|||||||0.0081
91685838|NCT00976911|183262228|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.379|||<|0.0001|TWO_SIDED|95.0|0.296|0.485|||Log Rank||Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (less than \[\<\] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.|||0.485|0.296|<0.0001
91685839|NCT00976911|183262228|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.366|0.577|||Log Rank|Unstratified analysis||||0.577|0.366|<0.0001
91685840|NCT00976911|183262228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Unstratified analysis||||||<0.0001
91685841|NCT00976911|183262228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.||||||<0.0001
91685842|NCT00976911|183262229|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.833||||0.136|TWO_SIDED|95.0|0.655|1.059||Unstratified analysis|Log Rank|||||1.059|0.655|0.1360
91685843|NCT00976911|183262229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0715|TWO_SIDED|||||Unstratified analysis|Peto-Peto-Prentice|||||||0.0715
91685844|NCT00976911|183262229|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2711|TWO_SIDED|95.0|0.678|1.116||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Log Rank|||||1.116|0.678|0.2711
91685845|NCT00976911|183262229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Peto-Peto-Prentice|||||||0.0890
91685846|NCT00976911|183262230|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|8.8||||0.1859|TWO_SIDED|95.0|-3.8|21.4|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus Week 8/9||21.4|-3.8|0.1859
91487496|NCT02728596|182847626|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||2.88|0.41|0.87
91487497|NCT02728596|182847626|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||3.57|0.44|0.68
91487498|NCT02728596|182847627|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.39|1.95|||Regression, Logistic|Adjusted for cancer type.||||1.95|0.39|0.74
91685847|NCT00976911|183262230|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|3.5||||0.8309|TWO_SIDED|95.0|-14.0|20.9|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 16/18||20.9|-14|0.8309
91685848|NCT00976911|183262230|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|9.3||||0.579|TWO_SIDED|95.0|-15.0|34.1|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 24||34.1|-15|0.5790
91685849|NCT00976911|183262230|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|-4.8||||0.7339|TWO_SIDED|95.0|-40.0|30.6|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 30||30.6|-40|0.7339
91685850|NCT00230178|183262264|SUPERIORITY_OR_OTHER||Difference in response rate %|21.0||||0.0009||95.0|8.6|32.7|||Wilson's method|||||32.7|8.6|0.0009
91685851|NCT00230178|183262264|SUPERIORITY_OR_OTHER||Difference in response rate %|12.3||||0.0632||95.0|-0.9|25.0|||Wilson's method|||||25.0|-0.9|0.0632
91685852|NCT00230178|183262265|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91685853|NCT00230178|183262265|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91487499|NCT02728596|182847627|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|Adjusted for cancer type.||||2.88|0.41|0.87
91487500|NCT02728596|182847627|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|Adjusted for cancer type.||This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.||3.57|0.44|0.68
91526980|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1786|TWO_SIDED|95.0|-0.6|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 2 SCCAI score||3.3|-0.6|0.1786
91526981|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5824|TWO_SIDED|95.0|-1.5|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 3 SCCAI score||2.7|-1.5|0.5824
91685854|NCT02652611|183262267|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.57|TWO_SIDED|95.0|-0.8|1.4|||t-test, 2 sided|||We reported the average pain and function from 6 to 24 months postinjury with 95% confidence intervals (CIs) and summarized pain and function at 6, 9, 12, 18, and 24 months postinjury with means and standard deviations and medians with interquartile ranges.||1.4|-0.8|=0.57
91685855|NCT02652611|183262268|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.21|TWO_SIDED|95.0|-2.9|12.3|||t-test, 2 sided|||||12.3|-2.9|0.21
91685856|NCT03577301|183262274|SUPERIORITY||Wald Chi Square|3.3||||0.35|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 3 months.||||||0.35
91685857|NCT03577301|183262274|SUPERIORITY||Wald Chi Square|1.97||||0.58|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 6 months.||||||0.58
91685858|NCT03577301|183262274|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 9 months.||||||0.64
91685859|NCT03577301|183262274|SUPERIORITY||Wald Chi Square|1.15||||0.76|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 12 months.||||||0.76
91685860|NCT03577301|183262275|SUPERIORITY||Wald Chi Square|3.08||||0.38|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 3 months.||||||0.38
91685861|NCT03577301|183262275|SUPERIORITY||Wald Chi Square|1.26||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 6 months.||||||0.74
91685862|NCT03577301|183262275|SUPERIORITY||Wald Chi Square|1.27||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 9 months.||||||0.74
91685863|NCT03577301|183262275|SUPERIORITY||Slope|3.66||||0.3|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 12 months.||||||0.300
91685864|NCT03577301|183262276|SUPERIORITY||Wald Chi Square|1.3||||0.73|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 3 months.||||||0.73
91685865|NCT03577301|183262276|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 6 months.||||||0.64
91685866|NCT03577301|183262276|SUPERIORITY||Wald Chi Square|0.64||||0.89|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 9 months.||||||0.89
91685867|NCT03577301|183262276|SUPERIORITY||Wald Chi Square|1.08||||0.78|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 12 months.||||||0.78
91685868|NCT03577301|183262277|SUPERIORITY||Wald Chi Square|2.37||||0.5|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 3 months.||||||0.50
91685869|NCT03577301|183262277|SUPERIORITY||Wald Chi Square|2.98||||0.34|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 6 months.||||||0.34
91685870|NCT03577301|183262277|SUPERIORITY||Wald Chi Square|1.59||||0.66|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 9 months.||||||0.66
91685871|NCT03577301|183262277|SUPERIORITY||Wald Chi Square|2.74||||0.43|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 12 months.||||||0.43
91487501|NCT04102189|182847710|SUPERIORITY||Treatment difference|-16.75|||<|0.0001|TWO_SIDED|95.0|-20.27|-13.23|||ANCOVA|||Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.||-13.23|-20.27|<.0001
91489398|NCT02484690|182851577|SUPERIORITY||Difference in Least Squares Means|2.79||||0.8475|TWO_SIDED|80.0|-15.8|21.37||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||21.37|-15.8|0.8475
91489399|NCT02484690|182851577|SUPERIORITY||Difference in Least Squares Means|28.52||||0.0381|TWO_SIDED|80.0|10.93|46.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||46.11|10.93|0.0381
91685872|NCT00005957|183262281|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.72|1.13|||Log Rank||Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.|It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.||1.13|0.72|0.38
91685873|NCT00005957|183262282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.01|TWO_SIDED|95.0|0.61|0.94|||Log Rank|||||0.94|0.61|0.01
91685874|NCT00606632|183262383|SUPERIORITY|||||||0.023|||||||McNemar|||||||0.023
91685875|NCT00606632|183262383|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
91685876|NCT03633825|183262392|SUPERIORITY||Risk Ratio (RR)|1.23|||=|0.02|TWO_SIDED|95.0|1.03|1.46|||Chi-squared|||||1.46|1.03|=.02
91685877|NCT03633825|183262393|SUPERIORITY||Risk Ratio (RR)|1.2|||=|0.19|TWO_SIDED|95.0|0.91|1.59|||Chi-squared|||||1.59|0.91|=.19
91722508|NCT03112603|183337820|OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.268|0.51||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.510|0.268|<0.0001
91722509|NCT03112603|183337821|OTHER||Hazard Ratio (HR)|0.361|||||TWO_SIDED|95.0|0.268|0.485|||||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.485|0.268|
91685878|NCT04841577|183262394|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for RSVPreF3 OA investigational vaccine is ≤ (equal to or smaller than) 1.5.|Adjusted group GMT ratio|1.27|||||TWO_SIDED|95.0|1.12|1.44||||||Adjusted ratios of Control group over Co-Ad Group in RSV-A Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-A neutralizing antibodies The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.44|1.12|
91685879|NCT04841577|183262395|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean titer ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35||||||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.35|1.02|
91685880|NCT04841577|183262395|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44||||||For the Flu A/Victoria/2570/2019 (H1N1) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.44|1.03|
91685881|NCT04841577|183262395|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.17|||||TWO_SIDED|95.0|1.04|1.32||||||For the Flu B/Phuket/3073/2013 (Yamagata) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.32|1.04|
91685882|NCT04841577|183262395|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26||||||For the Flu B/Washington/02/2019 (Victoria) strain, an ANOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.26|0.95|
91685883|NCT04841577|183262396|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|2.6|||||TWO_SIDED|95.0|-4.13|9.3|||Miettinen and Nurminen|||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.30|-4.13|
91719595|NCT03729362|183332133|SUPERIORITY|Analysis used a mixed-effect model for repeated measures (MMRM). The model included terms for treatment, baseline 6MWD, age, height, weight (all as continuous covariates), enzyme replacement therapy (ERT) status (ERT-naïve versus ERT-experienced), gender, time, and treatment-by-time interaction. Time was used as a repeated measure, and an unstructured covariance approach was applied.|LS Mean Difference|14.21|STANDARD_ERROR_OF_MEAN|8.481||0.048|TWO_SIDED|95.0|-2.6|31.02||1-sided significance level of 0.025.|MMRM|||"The primary and key secondary endpoints were tested in hierarchical order as follows:~The test for the primary endpoint was conducted first at the 1-sided 0.025 significance level, and if significant, the ordered key secondary endpoints were similarly tested. If at any point the null hypothesis for superiority failed to be rejected, then that comparison and any other comparison below it could not be claimed as successful and would be considered nominal."||31.02|-2.6|0.048
91719596|NCT03729362|183332134|SUPERIORITY|The analysis used an Analysis of Covariance (ANCOVA) model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.156||0.012|TWO_SIDED|95.0|0.37|4.95||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in sitting FVC was the first of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||4.95|0.37|0.012
91719597|NCT03729362|183332135|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.727||0.095|TWO_SIDED|95.0|-0.48|2.4||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the MMT score for the lower extremities was the second of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.4|-0.48|0.095
91719598|NCT03729362|183332136|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|6.261||0.097|TWO_SIDED|95.0|-4.24|20.57||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 26 in 6MWD was the third of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||20.57|-4.24|0.097
91719599|NCT03729362|183332137|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|1.706||0.138|TWO_SIDED|95.0|-1.51|5.25||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Physical Function was the fourth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||5.25|-1.51|0.138
91487502|NCT03319173|182847748|OTHER||Mean Difference (Final Values)|8.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|7.79|8.7|||Regression, Linear|||||8.7|7.79|<0.0001
91685884|NCT04841577|183262396|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.53|||||TWO_SIDED|95.0|-0.77|9.83|||Miettinen and Nurminen|||For the Flu A/Victoria/2570/2019 (H1N1) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.83|-0.77|
91685885|NCT04841577|183262396|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.04|||||TWO_SIDED|95.0|-2.21|10.28|||Miettinen and Nurminen|||For the Flu B/Phuket/3073/2013 (Yamagata) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||10.28|-2.21|
91685886|NCT04841577|183262396|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|0.41|||||TWO_SIDED|95.0|-6.07|6.9|||Miettinen and Nurminen|||For the Flu B/Washington/02/2019 (Victoria) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||6.90|-6.07|
91487503|NCT03319173|182847749|OTHER||Estimate|0.35|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.31|0.39|||Regression, Linear|||||0.39|0.31|<0.0001
91487504|NCT03319173|182847750|OTHER||Estimate|0.46|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.41|0.52|||Regression, Linear|||||0.52|0.41|<0.0001
91487505|NCT03319173|182847751|OTHER||Estimate|0.514|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
91487506|NCT03319173|182847752|OTHER||Estimate|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Regression, Linear|||||0.49|0.40|<0.0001
91487507|NCT03319173|182847753|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Estimate|||||0.49|0.40|<0.0001
91487508|NCT03319173|182847754|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.72|0.78|||Regression, Linear|||||0.78|0.72|<0.0001
91487509|NCT03319173|182847755|OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.3|0.37|||Estimate|||||0.37|0.30|<0.0001
91487510|NCT03319173|182847756|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
91685887|NCT04841577|183262398|OTHER||Adjusted group GMT ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Adjusted ratios of Control group over Co-Ad Group in RSV-B Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-B neutralizing antibodies. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.51|1.09|
91685888|NCT01004003|183262422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.437|||||TWO_SIDED|95.0|0.805|2.565|||||"Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.565|0.805|
91685889|NCT01004003|183262425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.351|||||TWO_SIDED|95.0|0.779|2.343|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.343|0.779|
91685890|NCT01004003|183262426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.522|1.473|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.473|0.522|
91685891|NCT04856930|183262479|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.25||0.7841|TWO_SIDED|90.0|-2.42|1.73||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|Linear repeated measures model (LRMM)|||||1.73|-2.42|0.7841
91685892|NCT04856930|183262479|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.25||0.2885|TWO_SIDED|90.0|-0.74|3.4||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||3.40|-0.74|0.2885
91685893|NCT04856930|183262480|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|8.97||0.5939|TWO_SIDED|90.0|-19.66|10.07||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||10.07|-19.66|0.5939
91685894|NCT04856930|183262480|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.95||0.7002|TWO_SIDED|90.0|-11.38|18.29||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||18.29|-11.38|0.7002
91685895|NCT04856930|183262481|SUPERIORITY||Risk Difference (RD)|5.3|||||TWO_SIDED|90.0|-13.3|23.4|||||Estimate parameter and 90% CI was based on Unadjusted Risk Difference and exact unconditional confidence intervals (CI).|||23.4|-13.3|
91685896|NCT04856930|183262481|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|90.0|-14.6|21.0|||||Estimate parameter and 90% C was based on Unadjusted Risk Difference and exact unconditional CIs.|||21.0|-14.6|
91685897|NCT04856930|183262482|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7282|TWO_SIDED|90.0|-1.08|0.7||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.70|-1.08|0.7282
91719600|NCT03729362|183332138|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.092||0.515|TWO_SIDED|95.0|-2.12|2.2||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Fatigue was the fifth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.2|-2.12|0.515
91487511|NCT03319173|182847757|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
91487512|NCT03319173|182847758|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.71|0.8|||Regression, Linear|||||0.80|0.71|<0.0001
91487513|NCT03319173|182847759|OTHER||Estimate|0.51|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
91487514|NCT03319173|182847760|OTHER||Estimate|1.13|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|1.104|1.156|||Regression, Linear|||||1.156|1.104|<0.0001
91685898|NCT04856930|183262482|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.5019|TWO_SIDED|90.0|-1.25|0.53||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.53|-1.25|0.5019
91685899|NCT04856930|183262483|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7698|TWO_SIDED|90.0|-0.96|0.67||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.67|-0.96|0.7698
91685900|NCT04856930|183262483|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.7468|TWO_SIDED|90.0|-0.97|0.65||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.65|-0.97|0.7468
91685901|NCT04856930|183262484|SUPERIORITY||LS Mean Difference|-25.7|STANDARD_ERROR_OF_MEAN|23.46||0.275|TWO_SIDED|90.0|-64.57|13.14||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||13.14|-64.57|0.2750
91685902|NCT04856930|183262484|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|23.81||0.3757|TWO_SIDED|90.0|-60.6|18.28||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||18.28|-60.60|0.3757
91685903|NCT04856930|183262485|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|13.04||0.6146|TWO_SIDED|90.0|-28.22|15.05||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||15.05|-28.22|0.6146
91685904|NCT04856930|183262485|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|12.95||0.4951|TWO_SIDED|90.0|-30.35|12.62||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||12.62|-30.35|0.4951
91719601|NCT03729362|183332139|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|-1.414|STANDARD_ERROR_OF_MEAN|0.528||0.004|TWO_SIDED|95.0|-2.463|-0.364||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the total score for the GSGC was the sixth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||-0.364|-2.463|0.004
91719602|NCT03405870|183332167|OTHER|Determined maximum tolerated dose|Value of Maximum Tolerated Dose (g/kg)|1.6|||||TWO_SIDED|||||||||Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria.||||
91719603|NCT02807259|183332170|EQUIVALENCE|Power calculations did not account for stratification used in the randomisation or include adjustment for baseline levels of the outcome, since the correlation over time was not known. Results suggested that the trial had \>80% power to detect a risk ratio of 0.77, if the coefficient of between-cluster variation was between 0.15 and 0.25.|Odds Ratio (OR)|1.47||||0.298|TWO_SIDED|95.0|0.71|3.01|||Mixed Models Analysis|||Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).||3.01|0.71|0.298
91719604|NCT02807259|183332171|OTHER||Odds Ratio (OR)|1.38||||0.378|TWO_SIDED|95.0|0.68|2.81|||Mixed Models Analysis|||||2.81|0.68|0.378
91719605|NCT02807259|183332172|OTHER||Odds Ratio (OR)|0.93||||0.748|TWO_SIDED|95.0|0.58|1.47|||Mixed Models Analysis|||||1.47|0.58|0.748
91719606|NCT02807259|183332173|OTHER||Odds Ratio (OR)|0.62||||0.025|TWO_SIDED|95.0|0.4|0.94|||Mixed Models Analysis|||||0.94|0.4|0.025
91719607|NCT02807259|183332174|OTHER||Odds Ratio (OR)|2.07||||0.372|TWO_SIDED|95.0|0.42|10.26|||Mixed Models Analysis|||||10.26|0.42|0.372
91719608|NCT02807259|183332175|OTHER||Odds Ratio (OR)|0.96||||0.845|TWO_SIDED|95.0|0.61|1.5|||Mixed Models Analysis|||||1.50|0.61|0.845
91719609|NCT02807259|183332176|OTHER||Odds Ratio (OR)|1.69||||0.042|TWO_SIDED|95.0|1.02|2.82|||Mixed Models Analysis|||||2.82|1.02|0.042
91719610|NCT00849056|183332182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.56|||ANCOVA|||||-0.56|-0.95|<0.0001
91487515|NCT03319173|182847761|OTHER||Estimate|1.037|||<|0.0001|TWO_SIDED|95.0|1.025|1.049|||Regression, Linear|||||1.049|1.025|<0.0001
91487516|NCT03319173|182847762|OTHER||Estimate|0.93|STANDARD_ERROR_OF_MEAN|0.008|<|0.0001|TWO_SIDED|95.0|0.91|0.94|||Regression, Linear|||||0.94|0.91|<0.0001
91487517|NCT03319173|182847763|OTHER||Estimate|1.122|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|1.096|1.149|||Regression, Linear|||||1.149|1.096|<0.0001
91685905|NCT04933383|183262495|SUPERIORITY||difference/ratio of least square means|180.6||||0.000813|TWO_SIDED|95.0|106.42|306.48|||ANCOVA|||"The primary efficacy endpoint is the change from baseline in PC20 after each treatment period (baseline is defined at Visit 1).~For primary efficacy analysis, the mean PC20 changes from baseline between AQ001S and the comparator were compared by analysis of covariance (ANCOVA) for crossover design. A p-value was calculated for the difference of the parameter between AQ001S and the comparator.~Additionally, an adjusted 95%-CI for the mean difference was obtained by the ANCOVA."||306.48|106.42|0.000813
91685906|NCT02237092|183262509|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91722510|NCT03112603|183337822|OTHER||Odds Ratio (OR)|2.17||||0.0011|TWO_SIDED|95.0|1.34|3.52||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel||The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.|||3.52|1.34|0.0011
91487518|NCT00316719|182847789|NON_INFERIORITY_OR_EQUIVALENCE|This is a Non-inferiority Analysis with the margin of -1.0.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.309|<|0.001||95.0|-0.94|0.28|||ANCOVA|||||0.28|-0.94|<0.001
91487519|NCT00573183|182847805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3404|STANDARD_ERROR_OF_MEAN|0.4134|<|0.05|TWO_SIDED|95.0|1.2019|9.2842||95% confidence interval|Mixed Models Analysis|A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.|The STAGE-12 group represented the numerator and TAU represented the reference group/denominator|Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.||9.2842|1.2019|<0.05
91487520|NCT00573183|182847805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4373|STANDARD_ERROR_OF_MEAN|0.4134|<|0.01|TWO_SIDED|95.0|1.0131|5.8637|||Mixed Models Analysis|||||5.8637|1.0131|<0.01
91487521|NCT00573183|182847806|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical Model - zero-inflated negative binomial random-effects regression|Zero-inflated negative binomial random-e|Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance||Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups||||<0.05
91685907|NCT02237092|183262510|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91685908|NCT02237092|183262511|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||t-test, 2 sided|||||||<0.02
91685909|NCT02237092|183262512|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.58|||<|0.05|TWO_SIDED|95.0|1.05|2.58|||NNT|||||2.58|1.05|<0.05
91685910|NCT02075515|183262519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjusted GMC Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09|||ANCOVA|||||1.09|0.86|
91722511|NCT03112603|183337824|OTHER||Odds Ratio (OR)|2.77|||<|0.0001|TWO_SIDED|95.0|1.75|4.39||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel (CMH) test.|Cochran-Mantel-Haenszel||The odds ratio and 95% CI were calculated using a stratified CMH test.|||4.39|1.75|<0.0001
91722512|NCT03112603|183337826|OTHER||Hazard Ratio (HR)|0.851||||0.2396|TWO_SIDED|95.0|0.544|1.331||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||1.331|0.544|0.2396
91487522|NCT00676338|182847873|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.62|TWO_SIDED|98.3|-0.26|0.17||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.17|-0.26|0.620
91685911|NCT02075515|183262519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjustd GMC Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08|||ANCOVA|||||1.08|0.85|
91685912|NCT02075515|183262519|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\].|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANCOVA|||||1.10|0.88|
91685913|NCT01297985|183262529|SUPERIORITY||MIXREG Estimate|1.55|STANDARD_ERROR_OF_MEAN|0.62||0.013|TWO_SIDED||||||Mixed Effects Random Regression|||"This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime; and that intervention participants would report greater increases in hopefulness than controls, also maintained longitudinally~This first model reports on Recovery over time."||||.013
91685914|NCT01297985|183262530|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this first model included depressive symptoms as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes depressive symptoms as the moderator (High depressive symptoms X time X study condition)"||||0.01
91685915|NCT01297985|183262530|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator||"We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes anxiety as the moderator (high anxiety X time X study condition)"||||0.01
91685916|NCT01297985|183262530|SUPERIORITY||MIXREG Estimate|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.022|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes general symptom distress as the moderator (high symptom distress X time X study condition)"||||.022
91685917|NCT01297985|183262531|SUPERIORITY||MIXREG Estimate|0.33|STANDARD_ERROR_OF_MEAN|0.012|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in Hopefulness that would be maintained longitudinally||||<.01
91685918|NCT01297985|183262532|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This analysis Mixed Effects Random Regression Modeling to test whether self-advocacy scores changed overtime by study condition status. Reported below are findings for the self-advocacy assertiveness sub scale.||||<0.01
91685919|NCT01297985|183262533|SUPERIORITY||MIXREG Estimate|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.017|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.017
91685920|NCT02032680|183262542|SUPERIORITY|||||||0.3749|||||||Cochran-Armitage Trend Test|||The two treatments were compared to see whether participants in one achieved a higher level on their goals (i.e., the maximum level achieved on the goal).||||0.3749
91685921|NCT03593395|183262549|OTHER|Estimation only|Least Square Mean Estimate|2.46|||||TWO_SIDED|95.0|1.81|3.34|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||3.34|1.81|
91685922|NCT03593395|183262549|OTHER|Estimation only.|Least Square Mean Estimate|2.96|||||TWO_SIDED|95.0|2.09|4.19|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||4.19|2.09|
91685923|NCT03713632|183262562|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0149|TWO_SIDED|95.0|1.05|2.55||one-sided p-value|Regression, Logistic|||||2.55|1.05|0.0149
91685924|NCT03713632|183262562|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.22|2.96||one-sided p-value|Regression, Logistic|||||2.96|1.22|0.0022
91685925|NCT03713632|183262563|SUPERIORITY||Mean Difference (Net)|-16.33||||0.0051|TWO_SIDED|95.0|-28.79|-3.88||one-side p-value|ANCOVA|||||-3.88|-28.79|0.0051
91719611|NCT04588259|183332190|NON_INFERIORITY|The upper limit of the 95% confidence interval (CI) for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment difference|-0.05||||0.5102|TWO_SIDED|95.0|-0.19|0.09||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.||0.09|-0.19|0.5102
91719612|NCT04588259|183332191|NON_INFERIORITY|The upper limit of the 95% CI for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment Difference|-0.52||||0.5102|TWO_SIDED|95.0|-2.08|1.03||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.||1.03|-2.08|0.5102
91719613|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site||Independent reader assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||0.224
91719614|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH was stratified by study site||Investigator assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||<0.001
91719615|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||0.002
91487523|NCT00676338|182847873|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.328|TWO_SIDED|98.3|-0.15|0.35||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.35|-0.15|0.328
91487524|NCT00676338|182847873|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|98.3|-0.62|-0.13||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.13|-0.62|<.001
91487525|NCT00676338|182847874|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.151
91719616|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||<0.001
91719617|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||>0.05
91719618|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.024
91719619|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.099
91719620|NCT00274456|183332232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.002
91487526|NCT00676338|182847874|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.913
91685926|NCT03713632|183262563|SUPERIORITY||Mean Difference (Net)|-22.94||||0.0001|TWO_SIDED|95.0|-35.24|-10.63||one-side p-value|ANCOVA|||||-10.63|-35.24|0.0001
91487527|NCT00676338|182847874|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||<.001
91487528|NCT00676338|182847875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.155|TWO_SIDED|95.0|-0.66|0.1||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.10|-0.66|0.155
91685927|NCT03713632|183262564|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0732|TWO_SIDED|95.0|0.41|1.14||one-sided p-value|Regression, Logistic|||||1.14|0.41|0.0732
91685928|NCT03713632|183262564|SUPERIORITY||Odds Ratio (OR)|0.49||||0.0049|TWO_SIDED|95.0|0.29|0.84||one-sided p-value|Regression, Logistic|||||0.84|0.29|0.0049
91685929|NCT03713632|183262565|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0026|TWO_SIDED|95.0|1.28|4.09||one-sided p-value|Regression, Logistic|||||4.09|1.28|0.0026
91685930|NCT03713632|183262565|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0206|TWO_SIDED|95.0|1.03|3.37||one-sided p-value|Regression, Logistic|||||3.37|1.03|0.0206
91685931|NCT02370238|183262582|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.589|TWO_SIDED|95.0|0.71|1.81||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.81|0.71|0.589
91685932|NCT02370238|183262583|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.897|TWO_SIDED|95.0|0.64|1.65||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.65|0.64|0.897
91685933|NCT02370238|183262584|SUPERIORITY||Odds Ratio (OR)|1.262||||0.667|TWO_SIDED|95.0|0.4909|3.963||P-value is based on Zelen's test for homogeneity of the odds ratios.|Zelen's test|||||3.963|0.4909|0.667
91685934|NCT02370238|183262586|SUPERIORITY|||||||0.767||||||For the All Patients group, p-value was based on a log-rank test stratified by actual sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||||0.767
91685935|NCT02370238|183262587|SUPERIORITY||Odds Ratio (OR)|1.101||||0.667|TWO_SIDED|95.0|0.437|2.79||P-value was based on Zelen's test for homogeneity of the odds ratios|Zelen's test|||||2.790|0.437|0.667
91685936|NCT01937871|183262590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-2.25|-0.57||||||||-0.57|-2.25|
91685937|NCT01937871|183262594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-1.87|0.18||||||||0.18|-1.87|
91685938|NCT02652949|183262612|SUPERIORITY||Event rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
91685939|NCT03837743|183262644|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.42||0.022|TWO_SIDED||||||Paired t-test|||Difference in Change (week 4)||||0.022
91685940|NCT03837743|183262644|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.8||0.296|TWO_SIDED||||||Paired t-test|||Difference in Change (week 8)||||0.296
91685941|NCT05199090|183262651|OTHER||adjusted means|-1.9||||0.0182|TWO_SIDED|80.0|-2.9|-0.9|||MMRM analysis|||Comparison of adjusted means||-0.9|-2.9|0.0182
91685942|NCT05199090|183262651|OTHER||adjusted means|-1.3||||0.1205|TWO_SIDED|80.0|-2.4|-0.2|||MMRM analysis|||||-0.2|-2.4|0.1205
91685943|NCT05199090|183262651|OTHER||adjusted means|-1.3||||0.0931|TWO_SIDED|80.0|-2.2|-0.3|||MMRM analysis|||||-0.3|-2.2|0.0931
91685944|NCT05199090|183262651|OTHER||adjusted means|0.6||||0.4994|TWO_SIDED|80.0|-0.5|1.7|||MMRM analysis|||||1.7|-0.5|0.4994
91685945|NCT05199090|183262651|OTHER||adjusted means|1.0||||0.2295|TWO_SIDED|80.0|-0.1|2.1|||MMRM analysis|||||2.1|-0.1|0.2295
91685946|NCT05199090|183262651|OTHER||adjusted means|-0.7||||0.2114|TWO_SIDED|80.0|-1.3|0.0|||MMRM analysis|||||0.0|-1.3|0.2114
91685947|NCT00384930|183262659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus Baseline.|Permutation Test|||This is the principal inferential analysis of the primary outcome.||||<0.001
91685948|NCT00384930|183262660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.025||95.0|-1.08|-0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.07|-1.08|0.025
91685949|NCT00384930|183262660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001||95.0|-1.4|-0.4||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.40|-1.40|<0.001
91685950|NCT00384930|183262660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|||<|0.001||95.0|-1.45|-0.46||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.46|-1.45|<0.001
91685951|NCT00384930|183262660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001||95.0|-1.58|-0.57||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.57|-1.58|<0.001
91685952|NCT00384930|183262661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.008||95.0|-1.69|-0.26||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.26|-1.69|0.008
91719621|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.027
91719622|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.009
91719623|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.017
91719624|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
91487529|NCT00676338|182847875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.22||0.153|TWO_SIDED|95.0|-0.12|0.75||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.75|-0.12|0.153
91487530|NCT00676338|182847875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.56|-0.68||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.68|-1.56|<.001
91487531|NCT00676338|182847876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.892|TWO_SIDED|95.0|-0.61|0.53||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.53|-0.61|0.892
91719625|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
91487532|NCT00676338|182847876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-4.21|-2.9||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-2.90|-4.21|<.001
91487533|NCT00676338|182847876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.92|-0.63||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.63|-1.92|<.001
91487534|NCT00676338|182847877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.08||0.873|TWO_SIDED|95.0|-0.18|0.15||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.15|-0.18|0.873
91719626|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
91719627|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.085
91487535|NCT00676338|182847877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.14|-0.52|<.001
91487536|NCT00676338|182847877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.41|-0.03||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.03|-0.41|0.022
91719628|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparison was performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed disease control rate (DCR), ie, SD \>= 16 weeks, or CR or PR||||0.007
91719629|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
91719630|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.009
91487537|NCT00676338|182847878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.004|TWO_SIDED|95.0|-0.09|-0.02||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.02|-0.09|0.004
91487538|NCT00676338|182847878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.19|-0.11||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.11|-0.19|<.001
91487539|NCT00676338|182847878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.142|TWO_SIDED|95.0|-0.07|0.01||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.01|-0.07|0.142
91685953|NCT00384930|183262661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69|||<|0.001||95.0|-2.4|-0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.98|-2.40|<0.001
91685954|NCT00384930|183262661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89|||<|0.001||95.0|-2.6|-1.18||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-1.18|-2.60|<0.001
91685955|NCT00384930|183262661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.87|||<|0.001||95.0|-2.59|-1.15||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-1.15|-2.59|<0.001
91685956|NCT00384930|183262662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.503||95.0|-0.28|0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.14|-0.28|0.503
91487540|NCT00676338|182847879|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.04||0.657|TWO_SIDED|95.0|0.94|1.1||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.10|0.94|0.657
91487541|NCT00676338|182847879|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|1.06|1.27||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.27|1.06|0.002
91487542|NCT00676338|182847879|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.04|STANDARD_ERROR_OF_MEAN|0.05||0.398|TWO_SIDED|95.0|0.95|1.14||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.14|0.95|0.398
91487543|NCT00676338|182847882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.09||0.201|TWO_SIDED|95.0|-3.52|0.74||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.74|-3.52|0.201
91487544|NCT00676338|182847882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.24||0.693|TWO_SIDED|95.0|-1.94|2.93||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.93|-1.94|0.693
91487545|NCT00676338|182847882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.22||0.646|TWO_SIDED|95.0|-1.84|2.96||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.96|-1.84|0.646
91487546|NCT00676338|182847883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.7||0.61|TWO_SIDED|95.0|-1.02|1.73||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.73|-1.02|0.610
91487547|NCT00676338|182847883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.013|TWO_SIDED|95.0|0.43|3.58||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||3.58|0.43|0.013
91487548|NCT00676338|182847883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.79||0.946|TWO_SIDED|95.0|-1.6|1.49||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.49|-1.60|0.946
91719631|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.005
91719632|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
91719633|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.098
91719634|NCT00274456|183332233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.014
91719635|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0498||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||Independent assessment||||0.0498
91719636|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.607||||0.0524|||||||Log Rank|||Independent assessment||||0.0524
91719637|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.495||||0.0065|||||||Log Rank|||Independent assessment||||0.0065
91719638|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
91719639|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
91719640|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
91719641|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
91719642|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.008
91719643|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719644|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719645|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.568||||0.012|||||||Log Rank|||Investigator assessment||||0.012
91719646|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.972||||0.001|||||||Log Rank|||Investigator assessment||||0.001
91526982|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1392|TWO_SIDED|95.0|-0.5|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 3 SCCAI score||3.5|-0.5|0.1392
91719647|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.702||||0.076|||||||Log Rank|||Investigator assessment||||0.076
91719648|NCT00274456|183332234|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719649|NCT00274456|183332235|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Independent assessment||||>0.05
91719650|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.013
91719651|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||Log Rank|||Investigator assessment||||0.022
91719652|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719653|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719654|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Log Rank|||Investigator assessment||||0.005
91719655|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719656|NCT00274456|183332236|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
91719657|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||||||0.047
91719658|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
91719659|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
91719660|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
91719661|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.686||||0.069||95.0|||||Log Rank|||||||0.069
91719662|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
91719663|NCT00274456|183332237|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.74||||0.008||95.0|||||Log Rank|||||||0.008
91719664|NCT02314546|183332241|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
91719665|NCT02314546|183332242|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
91719666|NCT02314546|183332243|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Kruskal-Wallis|||||||0.26
91719667|NCT02314546|183332244|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Kruskal-Wallis|||||||0.02
91719668|NCT02314546|183332245|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||||||0.04
91719669|NCT02314546|183332246|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
91719670|NCT02314546|183332247|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
91719671|NCT04476043|183332253|SUPERIORITY||Least squares mean (LSM) difference|-2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0277|TWO_SIDED|95.0|-5.2|-0.3|||MMRM|||||-0.3|-5.2|0.0277
91719672|NCT04476043|183332253|SUPERIORITY||LSM difference|-4.4|STANDARD_ERROR_OF_MEAN|1.25||0.0006|TWO_SIDED|95.0|-6.8|-1.9|||MMRM|||||-1.9|-6.8|0.0006
91719673|NCT04476043|183332253|SUPERIORITY||LSM difference|-3.8|STANDARD_ERROR_OF_MEAN|1.22||0.0021|TWO_SIDED|95.0|-6.2|-1.4|||MMRM|||||-1.4|-6.2|0.0021
91487549|NCT02122458|182847884|SUPERIORITY||Mean Difference (Net)|0.448||||0.05|TWO_SIDED|95.0|-8.66|9.56||Given the preliminary nature of this treatment study and the small number of participants the p-value was not adjusted for multiple comparisons.|Mixed Models Analysis|An Adjusted Rank Transform was applied to the data prior to applying the mixed model analyses.||The null hypothesis evaluated by the HHIA was that self-perceived hearing handicap would not reduce from baseline to 6-months post-fitting.||9.56|-8.66|.05
91719674|NCT04476043|183332254|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0445|TWO_SIDED|95.0|1.0|5.3|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||5.3|1.0|0.0445
91719675|NCT04476043|183332254|SUPERIORITY||Difference in response rate|19.2|STANDARD_ERROR_OF_MEAN|9.35|||||||||||Standard error of difference between response rates was from normal approximation.|||||
91719676|NCT04476043|183332254|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0998|TWO_SIDED|95.0|0.9|4.6|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.6|0.9|0.0998
91719677|NCT04476043|183332254|SUPERIORITY||Difference in response rate|15.4|STANDARD_ERROR_OF_MEAN|9.32|||||||||||Standard error of difference between response rates was from normal approximation.|||||
91719678|NCT04476043|183332254|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0829|TWO_SIDED|95.0|0.9|4.7|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.7|0.9|0.0829
91719679|NCT04476043|183332254|SUPERIORITY||Difference in response rate|16.4|STANDARD_ERROR_OF_MEAN|9.29|||||||||||Standard error of difference between response rates was from normal approximation.|||||
91719680|NCT02100631|183332264|NON_INFERIORITY|The lower limit of the two sided 95% Wald CI on the difference in seroconversion rate was estimated by inverting a Z test with pooled variance. The lower limit of the CI had be greater than -10 percentage points to prove non-inferiority. The lower bound of the CI on the older adults serconversion rate was required to exceed 70%.|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-6.7|0.4||||||||0.4|-6.7|
91719681|NCT02100631|183332265|OTHER||Geometric Mean Ratio (GMR)|0.44|||||TWO_SIDED|95.0|0.34|0.57||||||||0.57|0.34|
91487550|NCT02122458|182847885|SUPERIORITY|||||||0.05||||||Given the small sample size and the preliminary nature of this study, the p-value was not adjusted for multiple comparisons.|ANOVA|||||||.05
91487551|NCT02833350|182847890|SUPERIORITY||Weighted difference|8.0||||0.2503|TWO_SIDED|95.0|-5.64|21.64|||Cochran-Mantel-Haenszel|||||21.64|-5.64|0.2503
91487552|NCT02833350|182847890|SUPERIORITY||Weighted difference|12.93||||0.0164|TWO_SIDED|95.0|2.37|23.48|||Cochran-Mantel-Haenszel|||||23.48|2.37|0.0164
91487553|NCT02833350|182847890|SUPERIORITY||Weighted difference|20.0||||0.0003|TWO_SIDED|95.0|9.21|30.79|||Cochran-Mantel-Haenszel|||||30.79|9.21|0.0003
91526983|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9665|TWO_SIDED|95.0|-2.0|2.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 3 SCCAI score||2.1|-2.0|0.9665
91526984|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2455|TWO_SIDED|95.0|-0.9|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 3 SCCAI score||3.3|-0.9|0.2455
91719682|NCT02100631|183332266|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-2.2|3.5||||||||3.5|-2.2|
91719683|NCT02100631|183332267|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.||||||0.0062|||||||t-test, 2 sided|||||||0.0062
91719684|NCT00336544|183332270|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-5.7||||0.0769||95.0|-11.9|0.6|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.6|-11.9|0.0769
91719685|NCT00336544|183332272|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-4.4||||0.0775||95.0|-9.1|0.3|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.3|-9.1|0.0775
91719686|NCT00576758|183332274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26||||0.1587|TWO_SIDED|60.0|3.9|18.7|||Chi-squared|||||18.7|3.9|0.1587
91719687|NCT00576758|183332275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83|||||TWO_SIDED|95.0|-2.9|16.6||||||||16.6|-2.9|
91719688|NCT00576758|183332279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||||TWO_SIDED|95.0|-13.9|18.3||||||||18.3|-13.9|
91719689|NCT00576758|183332280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.44||||||||1.44|0.62|
91719690|NCT00576758|183332282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.67|1.5||||||||1.50|0.67|
91719691|NCT03427411|183332303|NON_INFERIORITY|Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).||||||0.6143||||||The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).|Fisher Exact|||||||0.6143
91487554|NCT02833350|182847892|SUPERIORITY||Weighted difference|-8.58||||0.1694|TWO_SIDED|95.0|-20.82|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.82|0.1694
91487555|NCT02833350|182847892|SUPERIORITY||Weighted difference|-1.5||||0.8132||95.0|-13.96|10.95|||Cochran-Mantel-Haenszel|||||10.95|-13.96|0.8132
91719692|NCT02631057|183332331|SUPERIORITY_OR_OTHER||Mean|-2.484|STANDARD_ERROR_OF_MEAN|0.629|<|0.001|TWO_SIDED|95.0|-3.717|-1.251|||Abadie-Imbens|LoS Average Treatment Effect on the Treated (ATET) \[Dabigatran group\], dispersion analysed with Abadie-Imbens's standard error.|The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as \[Dabigatran - Warfarin\] in the matched cohort of matching ratio 1:3.|||-1.251|-3.717|<0.001
91719693|NCT02690727|183332332|SUPERIORITY_OR_OTHER||Ratio (%)|128.49||||0.0002|TWO_SIDED|90.0|119.13|138.59|||ANOVA|||||138.59|119.13|0.0002
91719694|NCT02690727|183332334|SUPERIORITY_OR_OTHER||Ratio (%)|139.27||||0.0278|TWO_SIDED|90.0|111.01|174.73|||ANOVA|||||174.73|111.01|0.0278
91719695|NCT04757636|183332335|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|1.03||0.861409|TWO_SIDED|95.0|-2.2|1.84|||MMRM|||||1.84|-2.20|0.861409
91719696|NCT04757636|183332335|SUPERIORITY||Least Squares Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.029||0.416264|TWO_SIDED|95.0|-2.86|1.18|||MMRM|||||1.18|-2.86|0.416264
91719697|NCT04757636|183332336|SUPERIORITY||Risk Difference (RD)|0.1||||0.981348|TWO_SIDED|95.0|-7.5|7.7|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.7|-7.5|0.981348
91719698|NCT04757636|183332336|SUPERIORITY||Risk Difference (RD)|-0.7||||0.856|TWO_SIDED|95.0|-8.5|7.0|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.0|-8.5|0.856000
91487556|NCT02833350|182847893|SUPERIORITY||Weighted difference|13.7||||0.0717|TWO_SIDED|95.0|-1.21|28.61|||Cochran-Mantel-Haenszel|||||28.61|-1.21|0.0717
91487557|NCT02833350|182847897|SUPERIORITY||adjusted difference|-0.11||||0.8504|TWO_SIDED|95.0|-0.45|0.23|||ANCOVA|||Week 1, Day 7||0.23|-0.45|0.8504
91487558|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.04||||0.9884|TWO_SIDED|95.0|-0.28|0.21|||ANCOVA|||At week 1, Day 7||0.21|-0.28|0.9884
91719699|NCT04757636|183332337|SUPERIORITY||Risk Difference (RD)|-1.7||||0.655104|TWO_SIDED|95.0|-8.9|5.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||5.6|-8.9|0.655104
91719700|NCT04757636|183332337|SUPERIORITY||Risk Difference (RD)|-0.8||||0.821257|TWO_SIDED|95.0|-8.2|6.5|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.5|-8.2|0.821257
91719701|NCT04757636|183332338|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.234||0.199828|TWO_SIDED|95.0|-0.76|0.16|||MMRM|||||0.16|-0.76|0.199828
91719702|NCT04757636|183332338|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.235||0.188725|TWO_SIDED|95.0|-0.77|0.15|||MMRM|||||0.15|-0.77|0.188725
91719703|NCT04757636|183332339|SUPERIORITY||Risk Difference (RD)|-0.5||||0.84781|TWO_SIDED|95.0|-5.6|4.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||4.6|-5.6|0.847810
91719704|NCT04757636|183332339|SUPERIORITY||Risk Difference (RD)|0.9||||0.718699|TWO_SIDED|95.0|-4.2|6.1|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.1|-4.2|0.718699
91719705|NCT00091819|183332340|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|1.0||||||95.0|-4.8|6.8||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||6.8|-4.8|
91719706|NCT00701363|183332363|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||ANCOVA|||One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||||0.0013
91719707|NCT00701363|183332363|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91719708|NCT00701363|183332363|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91719709|NCT00701363|183332364|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||t-test, 2 sided|||||||0.0009
91719710|NCT00701363|183332364|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91719711|NCT00701363|183332364|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91487559|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.06||||0.923|TWO_SIDED|95.0|-0.31|0.18|||ANCOVA|||Week 1 Day 7||0.18|-0.31|0.9230
91487560|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.06||||0.9853|TWO_SIDED|95.0|-0.43|0.31|||ANCOVA|||Week 2, Day 14||0.31|-0.43|0.9853
91487561|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.12||||0.6826|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 2, Day 14||0.15|-0.38|0.6826
91487562|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.18||||0.2634|TWO_SIDED|95.0|-0.45|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.45|0.2634
91487563|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.29||||0.2885|TWO_SIDED|95.0|-0.72|0.14|||ANCOVA|||Week 4, Day 28||0.14|-0.72|0.2885
91719712|NCT00701363|183332364|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||t-test, 2 sided|||||||0.0170
91719713|NCT00701363|183332365|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED||||||t-test, 2 sided|||Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.||||0.0103
91719714|NCT03704064|183332383|SUPERIORITY||Mean Difference (Net)|-1.97|STANDARD_ERROR_OF_MEAN|1.32||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
91719715|NCT03704064|183332384|SUPERIORITY||Odds Ratio (OR)|1.1||||0.89|TWO_SIDED|95.0|0.4|3.4|||Mixed Models Analysis|||||3.4|0.4|0.89
91719716|NCT03704064|183332385|SUPERIORITY||Odds Ratio (OR)|3.7||||0.06|TWO_SIDED|95.0|1.0|14.7|||Mixed Models Analysis|||||14.7|1.0|0.06
91685957|NCT00384930|183262662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.206||95.0|-0.34|0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||0.07|-0.34|0.206
91685958|NCT00384930|183262662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.452||95.0|-0.28|0.13||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||0.13|-0.28|0.452
91685959|NCT00384930|183262662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.012||95.0|-0.47|-0.06||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.06|-0.47|0.012
91719717|NCT03704064|183332386|SUPERIORITY||Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
91685960|NCT00384930|183262663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.029||95.0|-0.49|-0.03||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.03|-0.49|0.029
91685961|NCT00384930|183262663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.002||95.0|-0.6|-0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.14|-0.60|0.002
91685962|NCT00384930|183262663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43|||<|0.001||95.0|-0.66|-0.19||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.19|-0.66|<0.001
91685963|NCT00384930|183262663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001||95.0|-0.64|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-0.64|<0.001
91685964|NCT00384930|183262664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.583||95.0|-0.58|0.33||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.33|-0.58|0.583
91685965|NCT00384930|183262664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.013||95.0|-1.03|-0.12||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.12|-1.03|0.013
91685966|NCT00384930|183262664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.016||95.0|-1.0|-0.1||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.10|-1.00|0.016
91685967|NCT00384930|183262664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.007||95.0|-1.08|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-1.08|0.007
91719718|NCT03704064|183332387|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.42
91719719|NCT03704064|183332388|SUPERIORITY||Odds Ratio (OR)|2.0||||0.24|TWO_SIDED|95.0|0.6|6.3|||Mixed Models Analysis|||||6.3|0.6|0.24
91719720|NCT03704064|183332389|SUPERIORITY||Odds Ratio (OR)|2.2||||0.24|TWO_SIDED|95.0|0.6|8.1|||Mixed Models Analysis|||||8.1|0.6|0.24
91719721|NCT03704064|183332390|SUPERIORITY||Odds Ratio (OR)|3.0||||0.07|TWO_SIDED|95.0|0.9|9.6|||Mixed Models Analysis|||||9.6|0.9|0.07
91487564|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.3||||0.0598|TWO_SIDED|95.0|-0.61|0.01|||ANCOVA|||Week 4, Day 28||0.01|-0.61|0.0598
91487565|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.31||||0.044|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Week 4, Day 28||-0.01|-0.62|0.0440
91487566|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.28||||0.4271|TWO_SIDED|95.0|-0.76|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.76|0.4271
91719722|NCT03704064|183332391|SUPERIORITY||Odds Ratio (OR)|2.6||||0.21|TWO_SIDED|95.0|0.6|11.4|||Mixed Models Analysis|||||11.4|0.6|0.21
91719723|NCT03704064|183332392|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|5.8||0.62|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.62
91719724|NCT03704064|183332392|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|4.5||0.92|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.92
91487567|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.31||||0.0969|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.66|0.0969
91487568|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.33||||0.0612|TWO_SIDED|95.0|-0.68|0.01|||ANCOVA|||Week 8, Day 56||0.01|-0.68|0.0612
91487569|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.36||||0.2079|TWO_SIDED|95.0|-0.84|0.12|||ANCOVA|||Week 12, Day 84||0.12|-0.84|0.2079
91487570|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
91487571|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
91487572|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.34|0.82|||ANCOVA|||Week 1, Day 7||0.82|0.34|<.0001
91719725|NCT03704064|183332392|SUPERIORITY||Mean Difference (Net)|13.4|STANDARD_ERROR_OF_MEAN|9.6||0.16|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.16
91719726|NCT03704064|183332392|SUPERIORITY||Mean Difference (Net)|15.9|STANDARD_ERROR_OF_MEAN|20.8||0.41|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.41
91719727|NCT03704064|183332393|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|6.1||0.46|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.46
91719728|NCT03704064|183332393|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.9||0.87|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.87
91719729|NCT03704064|183332393|SUPERIORITY||Mean Difference (Net)|18.5|STANDARD_ERROR_OF_MEAN|10.1||0.07|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.07
91719730|NCT03704064|183332393|SUPERIORITY||Mean Difference (Net)|30.0|STANDARD_ERROR_OF_MEAN|22.5||0.17|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.17
91719731|NCT03704064|183332394|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.63|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.63
91719732|NCT03704064|183332394|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.7||0.72|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.72
91719733|NCT03704064|183332394|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|9.4||0.52|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.52
91719734|NCT03704064|183332394|SUPERIORITY||Mean Difference (Net)|-21.8|STANDARD_ERROR_OF_MEAN|19.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.27
91719735|NCT03704064|183332395|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|151.2||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
91719736|NCT03704064|183332396|SUPERIORITY||Mean Difference (Net)|-111.7|STANDARD_ERROR_OF_MEAN|137.2||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
91719737|NCT03704064|183332397|SUPERIORITY||Mean Difference (Net)|163.2|STANDARD_ERROR_OF_MEAN|154.0||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
91719738|NCT03704064|183332398|SUPERIORITY||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|4.6||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
91719739|NCT03704064|183332399|SUPERIORITY||Mean Difference (Net)|5.3|STANDARD_ERROR_OF_MEAN|4.6||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
91487573|NCT02833350|182847897|SUPERIORITY||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.31|0.8|||ANCOVA|||Week 1, Day 7||0.80|0.31|<0.0001
91719740|NCT03704064|183332400|SUPERIORITY||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|4.5||0.48|TWO_SIDED||||||Mixed Models Analysis|||||||0.48
91719741|NCT03704064|183332401|SUPERIORITY||Mean Difference (Net)|4.9|STANDARD_ERROR_OF_MEAN|3.4||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
91719742|NCT03704064|183332402|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.4||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
91719743|NCT03704064|183332403|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|3.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
91719744|NCT03704064|183332404|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_ERROR_OF_MEAN|9.4||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
91719745|NCT03704064|183332405|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|9.1||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
91487574|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Week 2, Day 14||0.74|0.20|<.0001
91487575|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.4||||0.0009|TWO_SIDED|95.0|0.13|0.66|||ANCOVA|||Week 2, Day 14||0.66|0.13|0.0009
91719746|NCT03704064|183332406|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.5||0.8|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.80
91719747|NCT03704064|183332406|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.94
91719748|NCT03704064|183332407|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|2.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.07
91719749|NCT03704064|183332407|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.5||0.96|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.96
91719750|NCT03704064|183332408|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
91719751|NCT03704064|183332409|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
91719752|NCT03704064|183332410|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
91719753|NCT03704064|183332411|SUPERIORITY||Odds Ratio (OR)|1.7||||0.38|TWO_SIDED|95.0|0.5|5.9|||Mixed Models Analysis|||||5.9|0.5|0.38
91719754|NCT03704064|183332412|SUPERIORITY||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.3|3.3|||Mixed Models Analysis|||||3.3|0.3|0.95
91719755|NCT03704064|183332413|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.3|3.1|||Mixed Models Analysis|||||3.1|0.3|0.99
91719756|NCT03704064|183332414|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.6||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.06
91719757|NCT03704064|183332414|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.06
91719758|NCT03704064|183332414|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.19
91719759|NCT03704064|183332415|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.05|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.05
91719760|NCT03704064|183332415|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.18|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.18
91719761|NCT03704064|183332415|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.046|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.046
91719762|NCT03704064|183332416|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.07|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.07
91719763|NCT03704064|183332416|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.11
91719764|NCT03704064|183332416|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.15|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.15
91487576|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.56|||<|0.0001|TWO_SIDED|95.0|0.25|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.25|<.0001
91487577|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.55|||<|0.0001|TWO_SIDED|95.0|0.24|0.85|||ANCOVA|||Week 4, Day 28||0.85|0.24|<.0001
91487578|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.42||||0.0095|TWO_SIDED|95.0|0.08|0.76|||ANCOVA|||Week 8, Day 56||0.76|0.08|0.0095
91487579|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.4||||0.0153|TWO_SIDED|95.0|0.06|0.74|||ANCOVA|||Week 8, Day 56||0.74|0.06|0.0153
91685968|NCT00384930|183262665|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.133
91685969|NCT00384930|183262665|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.003
91685970|NCT00384930|183262665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
91685971|NCT00384930|183262665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
91685972|NCT00384930|183262666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.735||95.0|-0.69|0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.98|-0.69|0.735
91685973|NCT00384930|183262666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.355||95.0|-0.44|1.23||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||1.23|-0.44|0.355
91685974|NCT00384930|183262666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.433||95.0|-0.5|1.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||1.17|-0.50|0.433
91685975|NCT00384930|183262666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.089||95.0|-0.11|1.59||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||1.59|-0.11|0.089
91685976|NCT00384930|183262667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.001||95.0|1.56|5.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||5.17|1.56|<0.001
91685977|NCT00384930|183262667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|||<|0.001||95.0|2.95|6.54||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||6.54|2.95|<0.001
91685978|NCT00384930|183262667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.83|||<|0.001||95.0|4.04|7.62||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||7.62|4.04|<0.001
91685979|NCT00384930|183262667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.15|||<|0.001||95.0|4.35|7.95||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||7.95|4.35|<0.001
91685980|NCT00384930|183262668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58||||0.005||95.0|-2.68|-0.48||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-0.48|-2.68|0.005
91685981|NCT00384930|183262668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.001||95.0|-3.69|-1.51||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.51|-3.69|<0.001
91685982|NCT00384930|183262668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|||<|0.001||95.0|-3.99|-1.81||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.81|-3.99|<0.001
91685983|NCT00384930|183262668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.94|||<|0.001||95.0|-4.04|-1.84||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.84|-4.04|<0.001
91487580|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.19||||0.4839|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Week 12, Day 84||0.54|-0.16|0.4839
91487581|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|0.19||||0.5035|TWO_SIDED|95.0|-0.16|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.16|0.5035
91487582|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.11||||0.4286|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.38|0.4286
91487583|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.2||||0.1831|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Week 2, Day 14||0.10|-0.50|0.1831
91685984|NCT02686138|183262702|SUPERIORITY||Risk Difference (RD)|12.85|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91685985|NCT02686138|183262703|SUPERIORITY||Risk Difference (RD)|14.11|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91685986|NCT02686138|183262704|SUPERIORITY||Risk Difference (RD)|11.5||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.004
91685987|NCT02686138|183262705|SUPERIORITY||Risk Difference (RD)|11.16||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.003
91685988|NCT02686138|183262706|SUPERIORITY||Risk Difference (RD)|10.3||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.01
91685989|NCT02686138|183262707|SUPERIORITY||Risk Difference (RD)|10.17||||0.013|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.013
91685990|NCT02686138|183262708|SUPERIORITY||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91685991|NCT02686138|183262709|SUPERIORITY||Risk Difference (RD)|16.18|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91685992|NCT02686138|183262710|SUPERIORITY||Risk Difference (RD)|9.17||||0.015|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.015
91685993|NCT01685840|183262716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.88|TWO_SIDED|95.0|0.79|1.22||A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM.|Regression, Cox|||||1.22|0.79|0.88
91685994|NCT01685840|183262717|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.37|TWO_SIDED|95.0|0.62|1.2|||Regression, Cox|||||1.20|0.62|0.37
91685995|NCT01685840|183262718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0||||0.53|TWO_SIDED|95.0|-20.0|39.0|||Bang-Tsiatis Partitioned Estimator|||||39|-20|0.53
91487584|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.31||||0.0667|TWO_SIDED|95.0|-0.65|0.02|||ANCOVA|||Week 4, Day 28||0.02|-0.65|0.0667
91487585|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8, Day 56||-0.42|-1.11|<0.0001
91685996|NCT01685840|183262719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.65|1.37|||Regression, Cox|||||1.37|0.65|0.75
91685997|NCT01685840|183262720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Cox|||||1.31|0.82|0.76
91685998|NCT01685840|183262721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.08|TWO_SIDED|95.0|0.97|1.72|||Anderson-Gill Intensity Model|||||1.72|0.97|0.08
91685999|NCT01685840|183262722|SUPERIORITY|||||||0.636|||||||Mixed Models Analysis|||Baseline||||0.636
91686000|NCT01685840|183262722|SUPERIORITY|||||||0.628|||||||Mixed Models Analysis|||3 month||||0.628
91686001|NCT01685840|183262722|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||6 month||||0.586
91686002|NCT01685840|183262722|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||12 month||||0.669
91686003|NCT01685840|183262722|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||24 month||||0.949
91686004|NCT01685840|183262723|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.404|TWO_SIDED|95.0|-1.188|2.947||Adjusted P-value|Mixed Models Analysis|||3 month||2.947|-1.188|0.404
91686005|NCT01685840|183262723|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.219|TWO_SIDED|95.0|-0.881|3.836||Adjusted P-value|Mixed Models Analysis|||6 month||3.836|-0.881|0.219
91686006|NCT01685840|183262723|SUPERIORITY||Mean Difference (Final Values)|2.099||||0.104|TWO_SIDED|95.0|-0.433|4.63||Adjusted P-value|Mixed Models Analysis|||12 month||4.630|-0.433|0.104
91686007|NCT01685840|183262723|SUPERIORITY||Mean Difference (Final Values)|1.999||||0.228|TWO_SIDED|95.0|-1.253|5.25|||Mixed Models Analysis|||24 month||5.250|-1.253|0.228
91686008|NCT01685840|183262724|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.421|TWO_SIDED|95.0|-0.025|0.06||Adjusted P-value|Mixed Models Analysis|||3 month||0.060|-0.025|0.421
91686009|NCT01685840|183262724|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.239|TWO_SIDED|95.0|-0.018|0.074||Adjusted P-value|Mixed Models Analysis|||6 month||0.074|-0.018|0.239
91686010|NCT01685840|183262724|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.402|TWO_SIDED|95.0|-0.028|0.07|||Mixed Models Analysis|||12 month||0.070|-0.028|0.402
91686011|NCT01685840|183262724|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.78|TWO_SIDED|95.0|-0.057|0.076||Adjusted P-value|Mixed Models Analysis|||24 month||0.076|-0.057|0.780
91686012|NCT01685840|183262725|SUPERIORITY||Mean Difference (Final Values)|-2.131||||0.268|TWO_SIDED|95.0|-5.902|1.64||Adjusted P-value|Mixed Models Analysis|||3 month||1.640|-5.902|0.268
91686013|NCT01685840|183262725|SUPERIORITY||Mean Difference (Final Values)|1.069||||0.599|TWO_SIDED|95.0|-2.921|5.058|||Mixed Models Analysis|||6 month||5.058|-2.921|0.599
91686014|NCT01685840|183262725|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.852|TWO_SIDED|95.0|-4.486|3.707||Adjusted P-value|Mixed Models Analysis|||12 month||3.707|-4.486|0.852
91686015|NCT01685840|183262725|SUPERIORITY||Mean Difference (Final Values)|-3.343||||0.221|TWO_SIDED|95.0|-8.708|2.022||Adjusted P-value|Mixed Models Analysis|||24 month||2.022|-8.708|0.221
91686016|NCT01685840|183262726|SUPERIORITY||Mean Difference (Final Values)|-0.816||||0.615|TWO_SIDED|95.0|-3.999|2.367||Adjusted P-value|Mixed Models Analysis|||3 month||2.367|-3.999|0.615
91686017|NCT01685840|183262726|SUPERIORITY||Mean Difference (Final Values)|0.252||||0.878|TWO_SIDED|95.0|-2.977|3.482||Adjusted P-value|Mixed Models Analysis|||6 month||3.482|-2.977|0.878
91686018|NCT01685840|183262726|SUPERIORITY||Mean Difference (Final Values)|-1.406||||0.441|TWO_SIDED|95.0|-4.989|2.178||Adjusted P-value|Mixed Models Analysis|||12 month||2.178|-4.989|0.441
91686019|NCT01685840|183262726|SUPERIORITY||Mean Difference (Final Values)|1.091||||0.653|TWO_SIDED|95.0|-3.673|5.856||Adjusted P-value|Mixed Models Analysis|||24 month||5.856|-3.673|0.653
91686020|NCT01685840|183262727|SUPERIORITY||Mean Difference (Final Values)|-1.226||||0.199|TWO_SIDED|95.0|-3.097|0.645||Adjusted P-value|Mixed Models Analysis|||3 month||0.645|-3.097|0.199
91686021|NCT01685840|183262727|SUPERIORITY||Mean Difference (Final Values)|-0.742||||0.465|TWO_SIDED|95.0|-2.735|1.25|||Mixed Models Analysis|||6 month||1.250|-2.735|0.465
91686022|NCT01685840|183262727|SUPERIORITY||Mean Difference (Final Values)|-0.074||||0.943|TWO_SIDED|95.0|-2.119|1.97||Adjusted P-value|Mixed Models Analysis|||12 month||1.970|-2.119|0.943
91487586|NCT02833350|182847897|SUPERIORITY||Adjusted Difference|-0.76||||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|||Week 12, Day 84||-0.38|-1.15|0.0002
91487587|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.18||||0.5807|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.55|0.5807
91719765|NCT03704064|183332417|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.04
91719766|NCT03704064|183332417|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.35|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.35
91719767|NCT03704064|183332417|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
91719768|NCT03704064|183332417|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.01
91719769|NCT03704064|183332417|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||<0.001
91719770|NCT03704064|183332417|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||<0.001
91719771|NCT03704064|183332418|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.24|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.24
91719772|NCT03704064|183332418|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.28|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.28
91526985|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4644|TWO_SIDED|95.0|-1.4|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 4 SCCAI score||3.1|-1.4|0.4644
91719773|NCT03704064|183332418|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
91719774|NCT03704064|183332418|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.34
91719775|NCT03704064|183332418|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.008|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||0.008
91487588|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.12||||0.627|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.39|0.6270
91487589|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.15||||0.4475|TWO_SIDED|95.0|-0.42|0.12|||ANCOVA|||Week 1, Day 7||0.12|-0.42|0.4475
91487590|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.06||||0.9891|TWO_SIDED|95.0|-0.47|0.35|||ANCOVA|||Week 2, Day 14||0.35|-0.47|0.9891
91487591|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.21||||0.2244|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.51|0.2244
91526986|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4567|TWO_SIDED|95.0|-1.4|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 4 SCCAI score||3.0|-1.4|0.4567
91487592|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.28||||0.0586|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA|||Week 2, Day 14||0.01|-0.58|0.0586
91487593|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.39||||0.1338|TWO_SIDED|95.0|-0.85|0.08|||ANCOVA|||Week 4, Day 28||0.08|-0.85|0.1338
91487594|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.4||||0.0119|TWO_SIDED|95.0|-0.74|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.74|0.0119
91487595|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.44||||0.0046|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Week 4, Day 28||-0.11|-0.77|0.0046
91526987|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9594|TWO_SIDED|95.0|-2.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 4 SCCAI score||2.2|-2.3|0.9594
91719776|NCT03704064|183332418|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||0.001
91719777|NCT05033041|183332451|EQUIVALENCE|Equivalence is based on an equivalence hypothesis of -17mL \<difference in differences \< 17mL.||||||0.001|||||||t-test, 1 sided|||Comparison of the means using two one-sided t tests (TOST)||||.001
91719778|NCT00833755|183332502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||Kruskal-Wallis|||||||0.274
91719779|NCT00833755|183332503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Kruskal-Wallis|||||||0.552
91719780|NCT00833755|183332504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91719781|NCT00560404|183332523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15.|Difference of response rates|-0.02|||||TWO_SIDED|95.0|-0.25|0.2||||||||0.20|-0.25|
91719782|NCT04108468|183332561|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.064|TWO_SIDED|95.0|-1.12|0.03|||Regression, Linear|"Adjusted for baseline PASDAS and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.03|-1.12|0.064
91719783|NCT04108468|183332562|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.007|TWO_SIDED|95.0|-1.48|-0.24|||Regression, Linear|"Adjusted for baseline BASDAS and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||-0.24|-1.48|0.007
91719784|NCT04108468|183332563|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.096|TWO_SIDED|95.0|-1.26|0.11|||Regression, Linear|"Adjusted for baseline PASDAS and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.11|-1.26|0.096
91686023|NCT01685840|183262727|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.294|TWO_SIDED|95.0|-1.286|4.241||Adjusted P-value|Mixed Models Analysis|||24 month||4.241|-1.286|0.294
91686024|NCT01685840|183262728|SUPERIORITY||Mean Difference (Final Values)|-1.579||||0.294|TWO_SIDED|95.0|-4.527|1.369||Adjusted P-value|Mixed Models Analysis|||3 month||1.369|-4.527|0.294
91686025|NCT01685840|183262728|SUPERIORITY||Mean Difference (Final Values)|-0.946||||0.555|TWO_SIDED|95.0|-4.096|2.203||Adjusted P-value|Mixed Models Analysis|||6 month||2.203|-4.096|0.555
91686026|NCT01685840|183262728|SUPERIORITY||Mean Difference (Final Values)|-0.798||||0.643|TWO_SIDED|95.0|-4.178|2.583||Adjusted P-value|Mixed Models Analysis|||12 month||2.583|-4.178|0.643
91686027|NCT01685840|183262728|SUPERIORITY||Mean Difference (Final Values)|-0.647||||0.757|TWO_SIDED|95.0|-4.767|3.472||Adjusted P-value|Mixed Models Analysis|||24 month||3.472|-4.767|0.757
91686028|NCT01685840|183262729|SUPERIORITY||Mean Difference (Final Values)|-0.484||||0.837|TWO_SIDED|95.0|-5.102|4.133||Adjusted P-value|Mixed Models Analysis|||3 month||4.133|-5.102|0.837
91686029|NCT01685840|183262729|SUPERIORITY||Mean Difference (Final Values)|-2.693||||0.288|TWO_SIDED|95.0|-7.662|2.276||Adjusted P-value|Mixed Models Analysis|||6 month||2.276|-7.662|0.288
91686030|NCT01685840|183262729|SUPERIORITY||Mean Difference (Final Values)|-1.539||||0.567|TWO_SIDED|95.0|-6.81|3.732||Adjusted P-value|Mixed Models Analysis|||12 month||3.732|-6.810|0.567
91686031|NCT01685840|183262729|SUPERIORITY||Mean Difference (Final Values)|2.512||||0.475|TWO_SIDED|95.0|-4.394|9.419||Adjusted P-value|Mixed Models Analysis|||24 month||9.419|-4.394|0.475
91686032|NCT01685840|183262730|SUPERIORITY||Mean Difference (Final Values)|1.057||||0.696|TWO_SIDED|95.0|-4.25|6.364||Adjusted P-value|Mixed Models Analysis|||3 month||6.364|-4.250|0.696
91686033|NCT01685840|183262730|SUPERIORITY||Mean Difference (Final Values)|1.966||||0.497|TWO_SIDED|95.0|-3.715|7.647||Adjusted P-value|Mixed Models Analysis|||6 months||7.647|-3.715|0.497
91686034|NCT01685840|183262730|SUPERIORITY||Mean Difference (Final Values)|6.564||||0.035|TWO_SIDED|95.0|0.456|12.673||Adjusted P-value|Mixed Models Analysis|||12 month||12.673|0.456|0.035
91686035|NCT01685840|183262730|SUPERIORITY||Mean Difference (Final Values)|2.857||||0.488|TWO_SIDED|95.0|-5.247|10.961||Adjusted P-value|Mixed Models Analysis|||24 month||10.961|-5.247|0.488
91686036|NCT01685840|183262731|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.992|TWO_SIDED|95.0|-3.383|3.417||Adjusted P-value|Mixed Models Analysis|||3 month||3.417|-3.383|0.992
91686037|NCT01685840|183262731|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.882|TWO_SIDED|95.0|-3.409|3.969||Adjusted P-value|Mixed Models Analysis|||6 month||3.969|-3.409|0.882
91686038|NCT01685840|183262731|SUPERIORITY||Mean Difference (Final Values)|0.904||||0.647|TWO_SIDED|95.0|-2.973|4.782||Adjusted P-value|Mixed Models Analysis|||12 month||4.782|-2.973|0.647
91487596|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.31||||0.3943|TWO_SIDED|95.0|-0.82|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.82|0.3943
91686039|NCT01685840|183262731|SUPERIORITY||Mean Difference (Final Values)|0.322||||0.903|TWO_SIDED|95.0|-4.894|5.538||Adjusted P-value|Mixed Models Analysis|||24 month||5.538|-4.894|0.903
91686040|NCT01685840|183262732|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Hospitalizations||||0.74
91686041|NCT01685840|183262732|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||ER only events||||0.45
91686042|NCT01685840|183262732|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Rehab facilities||||0.67
91686043|NCT01685840|183262732|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Total admissions||||0.47
91686044|NCT01685840|183262733|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Hospital Costs||||0.88
91686045|NCT01685840|183262733|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Physician Fees||||0.69
91686046|NCT01685840|183262733|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Total Cost||||0.88
91686047|NCT00351533|183262780|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
91686048|NCT00351533|183262781|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
91686049|NCT00351533|183262782|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.16
91686050|NCT00351533|183262783|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
91686051|NCT00351533|183262784|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
91686052|NCT00351533|183262785|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
91686053|NCT00351533|183262786|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
91686054|NCT00351533|183262787|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
91686055|NCT00351533|183262788|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91686056|NCT00351533|183262789|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
91686057|NCT00351533|183262790|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
91686058|NCT00351533|183262791|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
91686059|NCT00351533|183262792|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
91686060|NCT00351533|183262793|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
91686061|NCT00351533|183262794|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
91686062|NCT00351533|183262795|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||0.27
91686063|NCT00351533|183262796|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
91686064|NCT00351533|183262797|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Chi-squared|||||||0.49
91686065|NCT00351533|183262798|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
91686066|NCT00351533|183262799|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.38
91686067|NCT00351533|183262800|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
91686068|NCT00351533|183262801|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
91719785|NCT04108468|183332564|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.844|TWO_SIDED|95.0|-0.72|0.59|||Regression, Linear|"Adjusted for baseline PASDAS and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.59|-0.72|0.844
91686069|NCT00351533|183262802|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
91686070|NCT00351533|183262803|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.71
91686071|NCT00351533|183262804|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
91686072|NCT00351533|183262805|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
91686073|NCT00351533|183262806|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
91686074|NCT00351533|183262807|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
91686075|NCT03390426|183262860|SUPERIORITY|"this is a superiority study and the non-inferiority or equivalence analysis is not required"|||||<|0.05||||||Comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.|t-test, 2 sided|Comparisons were made using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables.||We determined 30 subjects were needed to detect a 50% difference in THN incidence between the two groups using a one-sided Fisher's exact test with alpha = 0.05 and 80% power while allowing up to 20% drop-out. For primary and secondary outcomes, comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.||||<0.05
91686076|NCT03301623|183262888|SUPERIORITY||Mean Difference (Net)|-0.69||||0.541|TWO_SIDED|95.0|-2.9|1.52|||Mixed Models Analysis|Test is on interaction term between time (pre/post intervention) and treatment group (CDSvsPEAT) dummy variables in the regression model.|The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing pain interference over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.52|-2.9|.541
91686077|NCT03301623|183262889|SUPERIORITY||Odds Ratio (OR)|2.96||||0.019|TWO_SIDED|95.0|1.2|7.31|||Regression, Logistic|There were 69 providers with at least one CG-CAHPS response.|The interaction term describes the change in the PEAT group's scores in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving how satisfied patients feel over time after communicating with their physician about chronic pain treatment risks and benefits?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||7.31|1.20|.019
91686078|NCT03301623|183262890|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.719|TWO_SIDED|95.0|-2.73|1.88|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving physical function over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.88|-2.73|.719
91686079|NCT03301623|183262891|SUPERIORITY||Odds Ratio (OR)|1.63||||0.01|TWO_SIDED|95.0|1.13|2.36|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 morphine milligrams equivalent (MME) over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||2.36|1.13|.010
91686080|NCT03301623|183262892|SUPERIORITY||Odds Ratio (OR)|0.76||||0.51|TWO_SIDED|95.0|0.34|1.71|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|Question: Which communication strategy used during the clinical encounter is more effective in reducing co-prescription of opioids and benzodiazepines over time for patients with chronic pain who were taking opioids at baseline?||1.71|.34|.510
91686081|NCT03301623|183262893|SUPERIORITY||Odds Ratio (OR)|1.34||||0.26|TWO_SIDED|95.0|0.76|2.34|||Regression, Logistic|We employed robust standard errors clustered at the participant level. Time was controlled for using a fixed effect.|The interaction term describes the effect of PEAT in the post period.|PHQ-9 was categorized by assigning scores of 0, 1, 2, and 3 to the response categories (not at all: several days, more than half the days, nearly every day, respectively) and then summing. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The analysis was conducted as a multilevel ordered logistic regression.||2.34|.76|.260
91686082|NCT00315731|183262920|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-120)|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Ratio of AUC(0-120) is the ratio of AUC(0-120) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.12|0.85|
91686083|NCT00315731|183262921|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-168)|0.96|||||TWO_SIDED|90.0|0.83|1.11|||||Ratio of AUC(0-168) is the ratio of AUC(0-168) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.11|0.83|
91686084|NCT00315731|183262922|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0 to infinity)|0.93|||||TWO_SIDED|90.0|0.78|1.1||||||||1.10|0.78|
91686085|NCT00315731|183262923|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of Cmax|0.98|||||TWO_SIDED|90.0|0.87|1.11||||||||1.11|0.87|
91719786|NCT04108468|183332565|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.041|TWO_SIDED|95.0|-1.88|-0.04|||Regression, Linear|"Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||-0.04|-1.88|0.041
91719787|NCT04108468|183332566|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.375|TWO_SIDED|95.0|-1.41|0.54|||Regression, Linear|"Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.54|-1.41|0.375
91719788|NCT04108468|183332567|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.392|TWO_SIDED|95.0|-1.46|0.58|||Regression, Linear|"Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.58|-1.46|0.392
91719789|NCT04108468|183332568|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.541|TWO_SIDED|95.0|-1.34|0.71|||Regression, Linear|"Adjusted for baseline CPDAI and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.71|-1.34|0.541
91719790|NCT04108468|183332569|SUPERIORITY||Mean Difference (Final Values)|-2.35||||0.633|TWO_SIDED|95.0|-12.14|7.43|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||7.43|-12.14|0.633
91719791|NCT04108468|183332570|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.826|TWO_SIDED|95.0|-9.95|12.43|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||12.43|-9.95|0.826
91719792|NCT04108468|183332571|SUPERIORITY||Mean Difference (Final Values)|2.24||||0.268|TWO_SIDED|95.0|-1.76|6.25|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||6.25|-1.76|0.268
91487597|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.37||||0.0526|TWO_SIDED|95.0|-0.74|0.0|||ANCOVA|||Week 8, Day 56||0.00|-0.74|0.0526
91719793|NCT04108468|183332572|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.605|TWO_SIDED|95.0|-3.42|5.83|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||5.83|-3.42|0.605
91719794|NCT04108468|183332573|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.62|TWO_SIDED|95.0|-4.23|2.54|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||2.54|-4.23|0.620
91719795|NCT04108468|183332574|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.449|TWO_SIDED|95.0|-5.02|2.24|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||2.24|-5.02|0.449
91719796|NCT04108468|183332575|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.364|TWO_SIDED|95.0|-2.04|5.48|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||5.48|-2.04|0.364
91487598|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.39||||0.0365|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 8, Day 56||-0.02|-0.76|0.0365
91487599|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.41||||0.1696|TWO_SIDED|95.0|-0.93|0.11|||ANCOVA|||Week 12, Day 84||0.11|-0.93|0.1696
91487600|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.63||||0.0002|TWO_SIDED|95.0|-1.01|-0.25|||ANCOVA|||Week 12, Day 84||-0.25|-1.01|0.0002
91487601|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.62||||0.0003|TWO_SIDED|95.0|-1.0|-0.24|||ANCOVA|||Week 12, Day 84||-0.24|-1.00|0.0003
91487602|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.37|0.9|||ANCOVA|||Week 1, Day 7||0.90|0.37|<0.0001
91487603|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.34|0.88|||ANCOVA|||Week 1, Day 7||0.88|0.34|<0.0001
91487604|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.5||||0.0001|TWO_SIDED|95.0|0.21|0.79|||ANCOVA|||Week 2, Day 14||0.79|0.21|0.0001
91487605|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.43||||0.0012|TWO_SIDED|95.0|0.14|0.72|||ANCOVA|||Week 2, Day 14||0.72|0.14|0.0012
91487606|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.25|0.91|||ANCOVA|||Week 4, Day 28||0.91|0.25|<0.0001
91719797|NCT04108468|183332576|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.806|TWO_SIDED|95.0|-3.6|4.61|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||4.61|-3.60|0.806
91719798|NCT04108468|183332577|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.588|TWO_SIDED|95.0|-2.79|4.89|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||4.89|-2.79|0.588
91719799|NCT04108468|183332578|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.372|TWO_SIDED|95.0|-2.45|0.93|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.93|-2.45|0.372
91719800|NCT04108468|183332579|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.781|TWO_SIDED|95.0|-2.05|1.55|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||1.55|-2.05|0.781
91719801|NCT04108468|183332580|SUPERIORITY||Mean Difference (Final Values)|-2.26||||0.037|TWO_SIDED|95.0|-4.39|-0.14|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||-0.14|-4.39|0.037
91719802|NCT04108468|183332581|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.058|TWO_SIDED|95.0|-1.93|0.03|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.03|-1.93|0.058
91719803|NCT04108468|183332582|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.213|TWO_SIDED|95.0|-1.54|0.35|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||0.35|-1.54|0.213
91719804|NCT04108468|183332583|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.606|TWO_SIDED|95.0|-0.88|1.5|||Regression, Linear|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The mean difference was adjusted pre-specified covariates, and calculated following multiple imputation. The individual group means reported were unadjusted, available case estimates. The placebo/methotrexate arm was the reference category.|||1.50|-0.88|0.606
91719805|NCT04108468|183332584|SUPERIORITY||Incidence-rate ratio|1.01||||0.971|TWO_SIDED|95.0|0.48|2.14|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate arm was the reference category.|||2.14|0.48|0.971
91719806|NCT04108468|183332585|SUPERIORITY||Incidence-rate ratio|1.1||||0.817|TWO_SIDED|95.0|0.49|2.46|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||2.46|0.49|0.817
91719807|NCT04108468|183332586|SUPERIORITY||Incidence-rate ratio|1.35||||0.441|TWO_SIDED|95.0|0.63|2.93|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||2.93|0.63|0.441
91487607|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.54||||0.0002|TWO_SIDED|95.0|0.21|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.21|0.0002
91487608|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.46||||0.0084|TWO_SIDED|95.0|0.09|0.82|||ANCOVA|||Week 8, Day 56||0.82|0.09|0.0084
91487609|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.44||||0.0124|TWO_SIDED|95.0|0.07|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.07|0.0124
91487610|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.15||||0.7565|TWO_SIDED|95.0|-0.23|0.52|||ANCOVA|||Week 12, Day 84||0.52|-0.23|0.7565
91719808|NCT04108468|183332587|SUPERIORITY||Incidence-rate ratio|1.29||||0.563|TWO_SIDED|95.0|0.55|3.03|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||3.03|0.55|0.563
91719809|NCT04108468|183332588|SUPERIORITY||Incidence-rate ratio|0.17||||0.083|TWO_SIDED|95.0|0.02|1.26|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||1.26|0.02|0.083
91719810|NCT04108468|183332589|SUPERIORITY||Incidence-rate ratio|0.26||||0.432|TWO_SIDED|95.0|0.01|7.64|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||7.64|0.01|0.432
91719811|NCT04108468|183332590|SUPERIORITY||Incidence-rate ratio|0.11||||0.071|TWO_SIDED|95.0|0.01|1.21|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||1.21|0.01|0.071
91719812|NCT04108468|183332591|SUPERIORITY||Incidence-rate ratio|0.06||||0.037|TWO_SIDED|95.0|0.0|0.84|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||0.84|0.00|0.037
91487611|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|0.16||||0.7158|TWO_SIDED|95.0|-0.22|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.22|0.7158
91719813|NCT04108468|183332592|SUPERIORITY||Incidence-rate ratio|0.68||||0.296|TWO_SIDED|95.0|0.32|1.41|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||1.41|0.32|0.296
91719814|NCT04108468|183332593|SUPERIORITY||Incidence-rate ratio|0.51||||0.081|TWO_SIDED|95.0|0.23|1.09|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||1.09|0.23|0.081
91487612|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.22||||0.1368|TWO_SIDED|95.0|-0.52|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.52|0.1368
91487613|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.28||||0.0974|TWO_SIDED|95.0|-0.62|0.05|||ANCOVA|||Week 2, Day 14||0.05|-0.62|0.0974
91487614|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.38||||0.0479|TWO_SIDED|95.0|-0.76|0.0|||ANCOVA|||Week 4, Day 28||-0.00|-0.76|0.0479
91487615|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.46|||ANCOVA|||Week 8, Day 56||-0.46|-1.22|<0.0001
91487616|NCT02833350|182847898|SUPERIORITY||Adjusted Difference|-0.83||||0.0001|TWO_SIDED|95.0|-1.24|-0.42|||ANCOVA|||Week 12, Day 84||-0.42|-1.24|0.0001
91719815|NCT04108468|183332594|SUPERIORITY||Incidence-rate ratio|0.75||||0.458|TWO_SIDED|95.0|0.36|1.59|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||1.59|0.36|0.458
91487617|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.09||||0.9193|TWO_SIDED|95.0|-0.41|0.24|||ANCOVA|||Week 1, Day 7||0.24|-0.41|0.9193
91719816|NCT04108468|183332595|SUPERIORITY||Incidence-rate ratio|1.12||||0.798|TWO_SIDED|95.0|0.46|2.72|||Negative binomial regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||2.72|0.46|0.798
91719817|NCT04108468|183332596|SUPERIORITY||Median Difference (Final Values)|-0.38||||0.512|TWO_SIDED|95.0|-1.53|0.77|||Quantile (median) regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||0.77|-1.53|0.512
91487618|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.1||||0.7062|TWO_SIDED|95.0|-0.33|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.33|0.7062
91487619|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.08||||0.8542|TWO_SIDED|95.0|-0.31|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.31|0.8542
91487620|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.13||||0.8095|TWO_SIDED|95.0|-0.51|0.24|||ANCOVA|||Week 2, Day 14||0.24|-0.51|0.8095
91487621|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.17||||0.3862|TWO_SIDED|95.0|-0.44|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.44|0.3862
91487622|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.16||||0.4328|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|||Week 2, Day 14||0.12|-0.43|0.4328
91487623|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.24||||0.4915|TWO_SIDED|95.0|-0.68|0.2|||ANCOVA|||Week 4, Day 28||0.20|-0.68|0.4915
91487624|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.26||||0.1441|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Week 4, Day 28||0.06|-0.58|0.1441
91719818|NCT04108468|183332597|SUPERIORITY||Median Difference (Final Values)|-0.44||||0.32|TWO_SIDED|95.0|-1.33|0.44|||Quantile (median) regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||0.44|-1.33|0.320
91487625|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.24||||0.189|TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Week 4, Day 28||0.07|-0.56|0.1890
91487626|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.25||||0.5566|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA|||Week 8, Day 56||-0.24|-0.74|0.5566
91487627|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.32||||0.092|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.68|0.0920
91487628|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.29||||0.1391|TWO_SIDED|95.0|-0.65|0.06|||ANCOVA|||Week 8, Day 56||0.06|-0.65|0.1391
91487629|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.35||||0.2873|TWO_SIDED|95.0|-0.86|0.17|||ANCOVA|||Week 12, Day 84||0.17|-0.86|0.2873
91487630|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.54||||0.002|TWO_SIDED|95.0|-0.91|-0.16|||ANCOVA|||Week 12, Day 84||-0.16|-0.91|0.0020
91487631|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.54||||0.0016|TWO_SIDED|95.0|-0.92|-0.17|||ANCOVA|||Week 12, Day 84||-0.17|-0.92|0.0016
91487632|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.31||||0.005|TWO_SIDED|95.0|0.07|0.55|||ANCOVA|||Week 1, Day 7||0.55|0.07|0.0050
91487633|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.33||||0.002|TWO_SIDED|95.0|0.1|0.57|||ANCOVA|||Week 1, Day 7||0.57|0.10|0.0020
91487634|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.35||||0.0082|TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Week 2, Day 14||0.62|0.07|0.0082
91487635|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.35||||0.0056|TWO_SIDED|95.0|0.08|0.63|||ANCOVA|||Week 2, Day 14||0.63|0.08|0.0056
91487636|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.5||||0.0004|TWO_SIDED|95.0|0.19|0.82|||ANCOVA|||Week 4, Day 28||0.82|0.19|0.0004
91487637|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.52||||0.0002|TWO_SIDED|95.0|0.21|0.84|||ANCOVA|||Week 4, Day 28||0.84|0.21|0.0002
91487638|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.34||||0.065|TWO_SIDED|95.0|-0.01|0.69|||ANCOVA|||Week 8, Day 56||0.69|-0.01|0.0650
91487639|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.37||||0.0365|TWO_SIDED|95.0|0.02|0.72|||ANCOVA|||Week 8, Day 56||0.72|0.02|0.0365
91487640|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.09||||0.9338|TWO_SIDED|95.0|-0.28|0.47|||ANCOVA|||Week 12, Day 84||0.47|-0.28|0.9338
91719819|NCT04108468|183332598|SUPERIORITY||Median Difference (Final Values)|-0.47||||0.22|TWO_SIDED|95.0|-1.22|0.28|||Quantile (median) regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||0.28|-1.22|0.220
91686086|NCT04123561|183262941|SUPERIORITY|"The primary efficacy endpoint is defined as the change from Injection 1 Baseline in WOMAC Pain on a normalized scale of 0-4 at Week 12 between the randomized TLC599 12mg and Placebo groups.~The least-squares mean, alongside its corresponding 95% confidence interval, was used to estimate the treatment difference between TLC599 and Placebo, utilizing two-sided p-values."|Least Squares Mean Difference (LSMD)|-0.171|STANDARD_ERROR_OF_MEAN|0.0819||0.0372|TWO_SIDED|95.0|-0.331|-0.01|||ANCOVA|Parameters estimated via REML using the Newton-Raphson algorithm, and the Kenward-Roger method calculates denominator degrees of freedom.||||-0.010|-0.331|0.0372
91686087|NCT02091466|183262954|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p \< 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.||||<0.05
91686088|NCT00676780|183262955|SUPERIORITY_OR_OTHER||||||=|0.027||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.027
91686089|NCT00676780|183262956|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.023
91686090|NCT00676780|183262957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is no change, i.e. median change = 0.0||||<0.001
91686091|NCT01613313|183262958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||No p value||This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.||||
91686092|NCT01613313|183262959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||||This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.||||
91686093|NCT00708227|183262960|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
91686094|NCT00708227|183262961|SUPERIORITY|||||||0.15|||||||ANOVA|||||||0.15
91686095|NCT00708227|183262962|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
91686096|NCT04007991|183262966|SUPERIORITY||Difference in Least Square Mean|-3.44|STANDARD_ERROR_OF_MEAN|1.351|=|0.011|TWO_SIDED|95.0|-6.09|-0.79||Change from baseline in YGTSS score as a continuous variable was based on mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model with an unstructured covariance matrix.|ANCOVA|||||-0.79|-6.09|=0.011
91686097|NCT03355469|183262987|SUPERIORITY||Mean Difference (Final Values)|3.53||||0.045|TWO_SIDED|95.0|0.08|6.99||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|Linear ANCOVA model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.99|0.08|0.045
91686098|NCT03355469|183262987|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.507|TWO_SIDED|95.0|-2.42|4.73||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||4.73|-2.42|0.507
91686099|NCT03355469|183262987|SUPERIORITY||Mean Difference (Final Values)|4.98||||0.014|TWO_SIDED|95.0|1.14|8.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.83|1.14|0.014
91686100|NCT03355469|183262987|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.237|TWO_SIDED|95.0|-1.66|6.42||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.42|-1.66|0.237
91686101|NCT03355469|183262987|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.486|TWO_SIDED|95.0|-2.8|5.7||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.70|-2.80|0.486
91686102|NCT03355469|183262987|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.081|TWO_SIDED|95.0|-0.53|8.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.19|-0.53|0.081
91686103|NCT03355469|183262988|SUPERIORITY||Mean Difference (Final Values)|0.0073||||0.373|TWO_SIDED|95.0|-0.0093|0.024||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0240|-0.0093|0.373
91686104|NCT03355469|183262988|SUPERIORITY||Mean Difference (Final Values)|0.0097||||0.198|TWO_SIDED|95.0|-0.0055|0.025||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0250|-0.0055|0.198
91686105|NCT03355469|183262988|SUPERIORITY||Mean Difference (Final Values)|0.0041||||0.622|TWO_SIDED|95.0|-0.0129|0.0211||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0211|-0.0129|0.622
91686106|NCT03355469|183262988|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.666|TWO_SIDED|95.0|-0.0136|0.0088||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0088|-0.0136|0.666
91686107|NCT03355469|183262988|SUPERIORITY||Mean Difference (Final Values)|-0.0032||||0.634|TWO_SIDED|95.0|-0.0169|0.0104||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0104|-0.0169|0.634
91686108|NCT03355469|183262988|SUPERIORITY||Mean Difference (Final Values)|-0.0056||||0.336|TWO_SIDED|95.0|-0.0174|0.0062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0062|-0.0174|0.336
91686109|NCT03355469|183262989|SUPERIORITY||Mean Difference (Final Values)|1.51||||0.671|TWO_SIDED|95.0|-5.68|8.69||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.69|-5.68|0.671
91686110|NCT03355469|183262989|SUPERIORITY||Mean Difference (Final Values)|-4.82||||0.17|TWO_SIDED|95.0|-11.84|2.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.19|-11.84|0.170
91686111|NCT03355469|183262989|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.839|TWO_SIDED|95.0|-7.29|5.97||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.97|-7.29|0.839
91686112|NCT03355469|183262989|SUPERIORITY||Mean Difference (Final Values)|6.33||||0.024|TWO_SIDED|95.0|0.86|11.8||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||11.80|0.86|0.024
91686113|NCT03355469|183262989|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.385|TWO_SIDED|95.0|-7.16|2.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.83|-7.16|0.385
91686114|NCT03355469|183262989|SUPERIORITY||Mean Difference (Final Values)|4.17||||0.08|TWO_SIDED|95.0|-0.53|8.86||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.86|-0.53|0.080
91719820|NCT04108468|183332599|SUPERIORITY||Median Difference (Final Values)|0.05||||0.912|TWO_SIDED|95.0|-0.85|0.95|||Quantile (median) regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||0.95|-0.85|0.912
91487641|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|0.09||||0.952|TWO_SIDED|95.0|-0.29|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.29|0.9520
91487642|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.19||||0.1496|TWO_SIDED|95.0|-0.45|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.45|0.1496
91487643|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.13||||0.3936|TWO_SIDED|95.0|-0.43|0.17|||ANCOVA|||Week 2, Day 14||0.17|-0.43|0.3936
91719821|NCT04108468|183332600|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.281|TWO_SIDED|95.0|-1.42|0.42|||Quantile (median) regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||0.42|-1.42|0.281
91719822|NCT04108468|183332601|SUPERIORITY||Median Difference (Final Values)|0.01||||0.985|TWO_SIDED|95.0|-1.44|1.47|||Quantile (median) regression|"Adjusted for baseline score and poly/oligoarthritis status (the stratification variable).~Multiple imputation addressed missing data."|The placebo/methotrexate group was the reference category.|||1.47|-1.44|0.985
91719823|NCT04108468|183332602|SUPERIORITY||Odds Ratio (OR)|1.08||||0.869|TWO_SIDED|95.0|0.45|2.6|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.60|0.45|0.869
91719824|NCT04108468|183332603|SUPERIORITY||Odds Ratio (OR)|0.9||||0.802|TWO_SIDED|95.0|0.38|2.13|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.13|0.38|0.802
91719825|NCT04108468|183332604|SUPERIORITY||Odds Ratio (OR)|1.14||||0.767|TWO_SIDED|95.0|0.48|2.72|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.72|0.48|0.767
91719826|NCT04108468|183332605|SUPERIORITY||Odds Ratio (OR)|0.63||||0.315|TWO_SIDED|95.0|0.26|1.55|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||1.55|0.26|0.315
91719827|NCT04108468|183332606|SUPERIORITY||Odds Ratio (OR)|1.34||||0.516|TWO_SIDED|95.0|0.55|3.27|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||3.27|0.55|0.516
91487644|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.35||||0.0346|TWO_SIDED|95.0|-0.68|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.68|0.0346
91487645|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.68||||0.0004|TWO_SIDED|95.0|-1.04|-0.31|||ANCOVA|||Week 8, Day 56||-0.31|-1.04|0.0004
91719828|NCT04108468|183332607|SUPERIORITY||Odds Ratio (OR)|0.97||||0.939|TWO_SIDED|95.0|0.39|2.38|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.38|0.39|0.939
91719829|NCT04108468|183332608|SUPERIORITY||Odds Ratio (OR)|1.19||||0.701|TWO_SIDED|95.0|0.48|2.94|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.94|0.48|0.701
91487646|NCT02833350|182847899|SUPERIORITY||Adjusted Difference|-0.73||||0.0003|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Week 12, Day 84||-0.34|-1.11|0.0003
91487647|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.17||||0.6083|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.53|0.6083
91487648|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.18||||0.2672|TWO_SIDED|95.0|-0.44|0.08|||ANCOVA|||Week 1, Day 7||0.08|-0.44|0.2672
91487649|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.17||||0.3158|TWO_SIDED|95.0|-0.43|0.09|||ANCOVA|||Week 1, Day 7||0.09|-0.43|0.3158
91487650|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.14||||0.8495|TWO_SIDED|95.0|-0.55|0.28|||ANCOVA|||Week 2, Day 14||0.28|-0.55|0.8495
91487651|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.28||||0.0856|TWO_SIDED|95.0|-0.58|0.03|||ANCOVA|||Week 2, Day 14||0.03|-0.58|0.0856
91487652|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.27||||0.1021|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA|||Week 2, Day 14||0.04|-0.57|0.1021
91487653|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.33||||0.2762|TWO_SIDED|95.0|-0.82|0.15|||ANCOVA|||Week 4, Day 28||0.15|-0.82|0.2762
91487654|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.38||||0.0286|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0286
91487655|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.38||||0.0274|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0274
91487656|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.28||||0.4981|TWO_SIDED|95.0|-0.81|0.24|||ANCOVA|||Week 8, Day 56||0.24|-0.81|0.4981
91487657|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.39||||0.0472|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 8, Day 56||-0.00|-0.78|0.0472
91487658|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.36||||0.0753|TWO_SIDED|95.0|-0.75|0.03|||ANCOVA|||Week 8, Day 56||0.03|-0.75|0.0753
91487659|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.43||||0.1853|TWO_SIDED|95.0|-0.99|0.13|||ANCOVA|||Week 12, Day 84||0.13|-0.99|0.1853
91487660|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.62||||0.0009|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0009
91487661|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.62||||0.0008|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0008
91719830|NCT04108468|183332609|SUPERIORITY||Odds Ratio (OR)|0.48||||0.124|TWO_SIDED|95.0|0.19|1.22|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||1.22|0.19|0.124
91719831|NCT04108468|183332610|SUPERIORITY||Odds Ratio (OR)|1.89||||0.161|TWO_SIDED|95.0|0.78|4.63|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||4.63|0.78|0.161
91719832|NCT04108468|183332611|SUPERIORITY||Odds Ratio (OR)|1.67||||0.251|TWO_SIDED|95.0|0.7|4.02|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||4.02|0.70|0.251
91719833|NCT04108468|183332612|SUPERIORITY||Odds Ratio (OR)|1.5||||0.363|TWO_SIDED|95.0|0.63|3.6|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||3.60|0.63|0.363
91487662|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.41||||0.0005|TWO_SIDED|95.0|0.15|0.67|||ANCOVA|||Week 1, Day 7||0.67|0.15|0.0005
91487663|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.42||||0.0003|TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Week 1, Day 7||0.68|0.16|0.0003
91526988|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5122|TWO_SIDED|95.0|-1.5|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 4 SCCAI score||3.0|-1.5|0.5122
91719834|NCT04108468|183332613|SUPERIORITY||Odds Ratio (OR)|0.99||||0.991|TWO_SIDED|95.0|0.4|2.46|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.46|0.40|0.991
91719835|NCT04108468|183332614|SUPERIORITY||Odds Ratio (OR)|3.12||||0.037|TWO_SIDED|95.0|1.07|9.1|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||9.10|1.07|0.037
91719836|NCT04108468|183332615|SUPERIORITY||Odds Ratio (OR)|2.5||||0.056|TWO_SIDED|95.0|0.98|6.4|||Regression, Logistic||The placebo/methotrexate group was the reference category.|||6.40|0.98|0.056
91719837|NCT04108468|183332616|SUPERIORITY||Odds Ratio (OR)|1.72||||0.277|TWO_SIDED|95.0|0.65|4.57|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||4.57|0.65|0.277
91719838|NCT04108468|183332617|SUPERIORITY||Odds Ratio (OR)|1.38||||0.548|TWO_SIDED|95.0|0.48|3.92|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||3.92|0.48|0.548
91719839|NCT04108468|183332618|SUPERIORITY||Odds Ratio (OR)|3.7||||0.018|TWO_SIDED|95.0|1.25|10.97|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||10.97|1.25|0.018
91719840|NCT04108468|183332619|SUPERIORITY||Odds Ratio (OR)|1.06||||0.926|TWO_SIDED|95.0|0.28|4.02|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||4.02|0.28|0.926
91719841|NCT04108468|183332620|SUPERIORITY||Odds Ratio (OR)|1.73||||0.385|TWO_SIDED|95.0|0.5|5.94|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||5.94|0.50|0.385
91719842|NCT04108468|183332621|SUPERIORITY||Odds Ratio (OR)|0.82||||0.684|TWO_SIDED|95.0|0.32|2.12|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||2.12|0.32|0.684
91719843|NCT04108468|183332622|SUPERIORITY||Odds Ratio (OR)|16.72||||0.063|TWO_SIDED|95.0|0.86|326.19|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||326.19|0.86|0.063
91719844|NCT04108468|183332623|SUPERIORITY||Odds Ratio (OR)|8.9||||0.041|TWO_SIDED|95.0|1.09|72.42|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||72.42|1.09|0.041
91719845|NCT04108468|183332624|SUPERIORITY||Odds Ratio (OR)|6.71||||0.069|TWO_SIDED|95.0|0.86|52.14|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||52.14|0.86|0.069
91719846|NCT04108468|183332625|SUPERIORITY||Odds Ratio (OR)|2.34||||0.397|TWO_SIDED|95.0|0.33|16.66|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||16.66|0.33|0.397
91719847|NCT04108468|183332626|SUPERIORITY||Odds Ratio (OR)|0.33||||0.309|TWO_SIDED|95.0|0.04|2.83|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate arm was the reference category.|||2.83|0.04|0.309
91719848|NCT04108468|183332627|SUPERIORITY||Odds Ratio (OR)|0.87||||0.871|TWO_SIDED|95.0|0.17|4.6|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||4.60|0.17|0.871
91719849|NCT04108468|183332628|SUPERIORITY||Odds Ratio (OR)|0.48||||0.555|TWO_SIDED|95.0|0.04|5.52|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||5.52|0.04|0.555
91487664|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.39||||0.006|TWO_SIDED|95.0|0.09|0.69|||ANCOVA|||Week 2, Day 14||0.69|0.09|0.0060
91487665|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.4||||0.0039|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Week 2, Day 14||0.70|0.10|0.0039
91526989|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.1493|TWO_SIDED|95.0|-0.7|4.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 5 SCCAI score||4.3|-0.7|0.1493
91487666|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.18|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.18|0.0007
91487667|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.19|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.19|0.0007
91487668|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.39||||0.045|TWO_SIDED|95.0|0.01|0.77|||ANCOVA|||Week 8, Day 56||0.77|0.01|0.0450
91487669|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.42||||0.0259|TWO_SIDED|95.0|0.04|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.04|0.0259
91526990|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.3478|TWO_SIDED|95.0|-1.3|3.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 5 SCCAI score||3.6|-1.3|0.3478
91719850|NCT04108468|183332629|SUPERIORITY||Odds Ratio (OR)|0.28||||0.009|TWO_SIDED|95.0|0.11|0.72|||Regression, Logistic|Adjusted for poly/oligoarthritis status (the stratification variable). Multiple imputation addressed missing data.|The placebo/methotrexate group was the reference category.|||0.72|0.11|0.009
91719851|NCT03260023|183332631|OTHER|Enough participants will be treated to obtain 22 evaluable as a first stage. If at least 3/22 participants are considered responders, the enrolment will be continued, otherwise it will be stopped. For the second stage of the trial, enough participants will be treated to obtain a total of 40 evaluable participants and consider the study positive if at least 8/40 of them are considered responders.||||||||||||||||A Simon's two-stage design will be used. The null hypothesis for response rate H0 is set at 10% corresponding to the response rate observed in second line participants, the alternate hypothesis of efficacy is set at HA=25%, the type I error α is set at 5% one sided, the type II error β is set at 20% (power=80%).|With a hierarchical strategy on the final analysis, a subgroup analysis performed in oropharyngeal SCCHN patients and with a null hypothesis for response rate (H0) set at 10% and the alternative hypothesis of efficacy set at HA = 35%, 18 oropharyngeal SCCHN patients would have been needed to reach a power of 81% and actual alpha at 2.8%. This analysis would have been considered positive with at least 5 responders among the 18 SCCHN patients. The second stage of the Simon's design has not been done following the decision to exclude oropharyngeal SCCHN and to change to a randomized controlled two-arms study (phase II part 2).|||
91719852|NCT03260023|183332632|SUPERIORITY|Statistical analysis is performed using a one-sided log-rank unstratified test to compare Progression-Free Survival of TG4001 in combination with avelumab vs avelumab alone in participants with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies and without liver metastases at baseline. PFS will be evaluated based on RECIST1.1.|Hazard Ratio (HR)|0.87||||0.281|TWO_SIDED|90.0|0.59|1.29|||Log Rank|Unstratified with one-sided p-value||Efficacy will be evaluated by comparing the PFS between TG4001 arm versus TG4001 \& avelumab arm with an adaptive approach. With one-sided type I error α at 5%, 76 events are needed to reach a power of 95%, corresponding to around 80 participants enrolled. To stick with initial timelines for final analyses and limiting the loss of statistical power, PFS analysis will be performed based on at least 69 events.||1.29|0.59|0.2810
91719853|NCT03260023|183332634|OTHER|||||||0.832||||||At level 0.05 without adjustments for multiplicity testing, pvalue is calculated using Cochran-Mantel-Haenszel Chi-Square test.|Cochran-Mantel-Haenszel|||In Phase II part 2 cohort A, statistical Test stratified by indication to compare the Overall Response Rate between TG4001+Avelumab versus Avelumab alone.||||0.832
91719854|NCT04220021|183332652|SUPERIORITY|For the sign and binomial test our two outcomes are decreased (success) percentage change in RAN protein levels and increased (failure) percentage change in RAN protein levels.||||||0.0245||||||A priori test for significance is p less than or equal to 0.05|Sign test|One-tailed sign and binomial test||Sign and binomial test with one-tail analysis where the null hypothesis predicts a 50/50 split (p=0.5) for two outcomes.||||0.0245
91719855|NCT04935879|183332675|SUPERIORITY||Rate ratio|0.95||||0.6967|TWO_SIDED|95.0|0.71|1.25|||Negative binomial regression model||Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.|Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea (HU) use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).||1.25|0.71|0.6967
91719856|NCT04935879|183332676|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4298|TWO_SIDED|95.0|0.63|1.22|||Log Rank|||Analysis was stratified by baseline HU use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).||1.22|0.63|0.4298
91719857|NCT04935879|183332678|SUPERIORITY||Difference in Percentage|10.3||||0.0912|TWO_SIDED|95.0|-1.6|22.2|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by baseline HU use (yes, no), number of VOCs in the 12 months prior to study entry (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).||22.2|-1.6|0.0912
91719858|NCT04935879|183332679|SUPERIORITY||Rate Ratio|1.02||||0.9246|TWO_SIDED|95.0|0.71|1.47|||Negative binomial regression model||Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.|Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline HU use (yes, no), number of VOCs in the 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of the world).||1.47|0.71|0.9246
91719859|NCT04935879|183332680|SUPERIORITY||Rate ratio|0.92|||=|0.8263|TWO_SIDED|95.0|0.46|1.87|||Negative binomial regression model||Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.|Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline HU use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).||1.87|0.46|=0.8263
91719860|NCT03054428|183332682|SUPERIORITY||percentage difference|22.0|||<|0.0001|TWO_SIDED|95.0|12.2|31.87||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (less than \[\<\] 60 kilogram \[kg\] vs greater than or equal to \[≥\] 60 kg).||31.87|12.2|< 0.0001
91719861|NCT03054428|183332682|SUPERIORITY||percentage difference|15.5|||=|0.0007|TWO_SIDED|95.0|6.7|24.31||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||24.31|6.7|= 0.0007
91719862|NCT03054428|183332683|SUPERIORITY||percentage difference|33.2|||<|0.0001|TWO_SIDED|95.0|21.07|45.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||45.39|21.07|< 0.0001
91487670|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.06||||0.9881|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9881
91487671|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|0.06||||0.9891|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9891
91487672|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.29||||0.0463|TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Week 1, Day 7||-0.00|-0.57|0.0463
91719863|NCT03054428|183332683|SUPERIORITY||percentage difference|29.9|||<|0.0001|TWO_SIDED|95.0|17.94|41.78||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||41.78|17.94|< 0.0001
91719864|NCT03054428|183332684|SUPERIORITY||Least Square (LS) Mean difference|-42.3|||<|0.0001|TWO_SIDED|95.0|-55.6|-29.04||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-29.04|-55.6|< 0.0001
91719865|NCT03054428|183332684|SUPERIORITY||LS Mean difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-54.44|-28.02||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-28.02|-54.44|< 0.0001
91719866|NCT03054428|183332685|SUPERIORITY||LS Mean difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-39.54|-18.38||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-18.38|-39.54|< 0.0001
91719867|NCT03054428|183332685|SUPERIORITY||LS Mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.45|15.63||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||15.63|-37.45|< 0.0001
91719868|NCT03054428|183332686|SUPERIORITY||percentage difference|39.4|||<|0.0001|TWO_SIDED|95.0|26.9|51.84||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by CMH test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||51.84|26.9|< 0.0001
91526991|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5238|TWO_SIDED|95.0|-1.7|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 5 SCCAI score||3.2|-1.7|0.5238
91526992|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4091|TWO_SIDED|95.0|-1.4|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 5 SCCAI score||3.5|-1.4|0.4091
91526993|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.2604|TWO_SIDED|95.0|-1.1|4.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 6 SCCAI score||4.0|-1.1|0.2604
91719869|NCT03054428|183332686|SUPERIORITY||percentage difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.97|41.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||41.32|16.97|< 0.0001
91719870|NCT03054428|183332687|SUPERIORITY||Percentage difference|31.8|||<|0.0001|TWO_SIDED|95.0|20.45|43.2||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||43.2|20.45|< 0.0001
91487673|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.23||||0.1867|TWO_SIDED|95.0|-0.56|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.56|0.1867
91487674|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.44||||0.0213|TWO_SIDED|95.0|-0.81|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.81|0.0213
91487675|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.78||||0.0003|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Week 8. Day 56||-0.37|-1.19|0.0003
91487676|NCT02833350|182847900|SUPERIORITY||Adjusted Difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4|||ANCOVA|||Week 12, Day 84||-0.40|-1.24|0.0002
91487677|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
91487678|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
91526994|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2809|TWO_SIDED|95.0|-1.1|3.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 6 SCCAI score||3.8|-1.1|0.2809
91487679|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|1.82||||0.3482|TWO_SIDED|95.0|-1.98|5.62|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.62|-1.98|0.3482
91719871|NCT03054428|183332687|SUPERIORITY||Percentage difference|21.7|||=|0.0001|TWO_SIDED|95.0|11.21|32.28||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||32.28|11.21|= 0.0001
91719872|NCT03880474|183332716|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Log Binominal Model|||||2.55|0.90|0.1146
91719873|NCT03880474|183332716|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Poisson Model with Robust Variance|||||2.55|0.90|0.1146
91719874|NCT03880474|183332717|OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.86|1.15|||Log Binomial Model|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|1.0000
91719875|NCT03880474|183332717|OTHER||Relative Risk|1.0||||0.9799|TWO_SIDED|95.0|0.86|1.15|||Poisson Model with Robust Variance|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|0.9799
91719876|NCT03880474|183332719|OTHER||Least Squares Mean Difference|-287.1||||0.3284|TWO_SIDED|95.0|-872.75|298.59|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Day 28||298.59|-872.75|0.3284
91719877|NCT03880474|183332719|OTHER||Least Squares Mean Difference|-13.39||||0.8468|TWO_SIDED|95.0|-152.26|125.47|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Week26||125.47|-152.26|0.8468
91719878|NCT03880474|183332719|OTHER||Least Squares Mean Difference|-465.7||||0.5087|TWO_SIDED|95.0|-1875.21|943.75|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Day 28||943.75|-1875.21|0.5087
91487680|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.71|-6.51|0.8979
91719879|NCT03880474|183332719|OTHER||Least Squares Mean Difference|-83.68||||0.7509|TWO_SIDED|95.0|-611.67|444.32|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Week 26||444.32|-611.67|0.7509
91719880|NCT03880474|183332719|OTHER||Least Squares Mean Difference|-81.17||||0.3398|TWO_SIDED|95.0|-250.72|88.39|||ANOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Day 28||88.39|-250.72|0.3398
91719881|NCT03880474|183332719|OTHER||Least Squares Mean Difference|26.15||||0.4154|TWO_SIDED|95.0|-37.95|90.26|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Week 26||90.26|-37.95|0.4154
91719882|NCT03880474|183332719|OTHER||Least Squares Mean Difference|22.84||||0.7193|TWO_SIDED|95.0|-104.5|150.18|||ANCOVA|||Titers of neutralizing antibodies against Influenza B/ Victoria at Day 28||150.18|-104.50|0.7193
91719883|NCT03880474|183332719|OTHER||Least Squares Mean Difference|52.38||||0.1496|TWO_SIDED|95.0|-19.59|124.35|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/ Victoria at Week 26||124.35|-19.59|0.1496
91719884|NCT03880474|183332719|OTHER||Least Squares Mean Difference|-16.76||||0.9044|TWO_SIDED|95.0|-296.57|263.06|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Day 28||263.06|-296.57|0.9044
91719885|NCT03880474|183332719|OTHER||Least Squares Mean Difference|38.64||||0.4198|TWO_SIDED|95.0|-56.97|134.24|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Week 26||134.24|-56.97|0.4198
91719886|NCT03880474|183332720|OTHER||Hazard Ratio (HR)|1.08||||0.4159|TWO_SIDED|95.0|0.9|1.28|||Regression, Cox|||||1.28|0.90|0.4159
91719887|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.955|TWO_SIDED|95.0|0.83|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Feeling Hot (AUC)||1.19|0.83|0.9550
91719888|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.0||||0.8933|TWO_SIDED|95.0|1.0|1.0|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Temperature (AUC)||1|1|0.8933
91719889|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2156|TWO_SIDED|95.0|0.7|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Cough (AUC)||1.09|0.7|0.2156
91719890|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.88||||0.2216|TWO_SIDED|95.0|0.71|1.1|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Sore Throat AUC||1.10|0.71|0.2216
91719891|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2306|TWO_SIDED|95.0|0.69|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Blocked Nose AUC||1.09|0.69|0.2306
91719892|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.8038|TWO_SIDED|95.0|0.97|1.13|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Chest Pain AUC||1.13|0.97|0.8038
91719893|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.9319|TWO_SIDED|95.0|0.84|1.21|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Muscle Pain AUC||1.21|0.84|0.9319
91719894|NCT03880474|183332721|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.8399|TWO_SIDED|95.0|0.86|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Shortness of Breath AUC||1.19|0.86|0.8399
91719895|NCT03880474|183332722|OTHER||Least Squares Mean Difference|743.78||||0|TWO_SIDED|95.0|443.71|1043.84|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Day 28 Nucleoprotein = NP, matrix1 = M1||1043.84|443.71|0
91487681|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.48|-4.30|0.5976
91487682|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|0.91||||0.6546|TWO_SIDED|95.0|-3.07|4.89|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.89|-3.07|0.6546
91487683|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|-0.8||||0.7988|TWO_SIDED|95.0|-6.95|5.35|||Cochran-Mantel-Haenszel|||Week 4 Day 28||5.35|-6.95|0.7988
91487684|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|0.01||||0.9975|TWO_SIDED|95.0|-4.35|4.36|||Cochran-Mantel-Haenszel|||Week 4 Day 28||4.36|-4.35|0.9975
91487685|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|4.55||||0.1185|TWO_SIDED|95.0|-1.16|10.25|||Cochran-Mantel-Haenszel|||Week 4, Day 28||10.25|-1.16|0.1185
91487686|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|-2.4||||0.4765|TWO_SIDED|95.0|-9.01|4.21|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.21|-9.01|0.4765
91719896|NCT03880474|183332722|OTHER||Least Squares Mean Difference|177.1||||0.0673|TWO_SIDED|95.0|-13.14|367.33|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Week 26 Nucleoprotein = NP, matrix1 = M1||367.33|-13.14|0.0673
91719897|NCT06070610|183332742|OTHER|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.|Adjusted geometric mean ratio (%)|101.97|||||TWO_SIDED|90.0|93.59|111.1|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 12.3|||111.10|93.59|
91719898|NCT06070610|183332743|OTHER|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.|Adjusted geometric mean ratio (%)|101.31|||||TWO_SIDED|90.0|93.6|109.65|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 11.4|||109.65|93.60|
91719899|NCT06070610|183332744|OTHER|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.|Adjusted geometric mean ratio (%)|101.11|||||TWO_SIDED|90.0|87.36|117.02|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 21.4|||117.02|87.36|
91719900|NCT06070610|183332745|OTHER|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.|Adjusted geometric mean ratio (%)|108.37|||||TWO_SIDED|90.0|102.58|114.49|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 7.5|||114.49|102.58|
91719901|NCT06070610|183332746|OTHER|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.|Adjusted geometric mean ratio (%)|108.82|||||TWO_SIDED|90.0|102.54|115.49|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 7.7|||115.49|102.54|
91719902|NCT06070610|183332747|OTHER|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.|Adjusted geometric mean ratio (%)|87.24|||||TWO_SIDED|90.0|75.27|101.11|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 20.5|||101.11|75.27|
91719903|NCT01499810|183332748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91719904|NCT01499810|183332750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91719905|NCT01499810|183332751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91719906|NCT01499810|183332752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91719907|NCT01499810|183332753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91719908|NCT01499810|183332754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91719909|NCT01499810|183332755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
91719910|NCT01499810|183332756|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
91487687|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|4.61||||0.1655|TWO_SIDED|95.0|-1.9|11.12|||Cochran-Mantel-Haenszel|||Week 8, Day 56||11.12|-1.90|0.1655
91719911|NCT01499810|183332757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
91719912|NCT01499810|183332758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
91719913|NCT01499810|183332759|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00007
91719914|NCT01499810|183332760|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00009
91719915|NCT01499810|183332761|SUPERIORITY_OR_OTHER_LEGACY|||||||4e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00004
91719916|NCT01499810|183332762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
91719917|NCT01499810|183332763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0007
91719918|NCT01499810|183332764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.001
91719919|NCT01499810|183332765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0004
91719920|NCT01499810|183332766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0002
91487688|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|8.18||||0.0234|TWO_SIDED|95.0|1.11|15.26|||Cochran-Mantel-Haenszel|||Week 8, Day 56||15.26|1.11|0.0234
91487689|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|3.2||||0.549|TWO_SIDED|95.0|-7.27|13.67|||Cochran-Mantel-Haenszel|||Week 12, Day 84||13.67|-7.27|0.5490
91487690|NCT02833350|182847901|SUPERIORITY||Mean Difference (Net)|15.62||||0.0003|TWO_SIDED|95.0|7.22|24.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||24.03|7.22|0.0003
91487691|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|10.91||||0.0044|TWO_SIDED|95.0|3.39|18.43|||Cochran-Mantel-Haenszel|||Week 12, Day 84||18.43|3.39|0.0044
91487692|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
91719921|NCT01499810|183332767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.57
91719922|NCT01499810|183332768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.54
91719923|NCT01499810|183332769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.87
91719924|NCT01499810|183332770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.77
91719925|NCT01499810|183332771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.06
91719926|NCT01499810|183332772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.07
91719927|NCT01499810|183332773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
91719928|NCT01499810|183332774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
91719929|NCT01499810|183332775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.72
91719930|NCT01499810|183332776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.37
91719931|NCT01499810|183332777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.99
91719932|NCT01499810|183332778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
91719933|NCT01499810|183332779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.08
91719934|NCT01499810|183332780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
91487693|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 2, Day 14||9.99|-8.62|0.8853
91719935|NCT01499810|183332781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.22
91719936|NCT01499810|183332782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.29
91719937|NCT01499810|183332783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.89
91487694|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
91526995|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6038|TWO_SIDED|95.0|-1.8|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 6 SCCAI score||3.1|-1.8|0.6038
91719938|NCT01499810|183332784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.65
91719939|NCT01499810|183332785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
91719940|NCT01499810|183332786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Repeated measures analysis|t-test, 2 sided|||Repeated measures analysis||||0.35
91719941|NCT01499810|183332787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.92
91719942|NCT01499810|183332788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
91719943|NCT01499810|183332789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.40
91719944|NCT01499810|183332790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.17
91487695|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 8, Day 56||9.99|-8.62|0.8853
91487696|NCT02833350|182847901|SUPERIORITY||Adjusted Difference|11.64||||0.0584|TWO_SIDED|95.0|-0.41|23.7|||Cochran-Mantel-Haenszel|||Week 12, Day 84||23.70|-0.41|0.0584
91487697|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
91487698|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.92|-2.92|1.0000
91487699|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
91487700|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
91719945|NCT01499810|183332791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.014
91719946|NCT05539131|183332821|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.862||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.862
91719947|NCT05539131|183332822|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.662||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.662
91719948|NCT05539131|183332823|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.318||||||This is p-valu regarding time and group.|ANOVA|||||||0.318
91719949|NCT05539131|183332824|SUPERIORITY|||||||0.273|||||||ANOVA|||||||0.273
91719950|NCT05539131|183332825|SUPERIORITY|||||||0.639|||||||ANOVA|||||||0.639
91719951|NCT05539131|183332826|SUPERIORITY|||||||0.452|||||||ANOVA|||||||0.452
91686115|NCT03355469|183262990|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.088|TWO_SIDED|95.0|-0.069|0.005||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.005|-0.069|0.088
91719952|NCT01732692|183332865|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.|Treatment Difference|0.0286|||<|0.001|ONE_SIDED|95.0|-0.097||||Exact Farrington - Manning||Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control||||-0.097|<0.001
91719953|NCT02030600|183332874|SUPERIORITY_OR_OTHER||Treatment ratio|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.8|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period"||0.80|0.61|<0.0001
91719954|NCT02030600|183332875|SUPERIORITY_OR_OTHER||Treatment ratio|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period."||0.74|0.46|<0.0001
91719955|NCT02030600|183332876|SUPERIORITY_OR_OTHER|||||||0.3458||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||"Stepwise hierarchical testing procedure:~Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes in the maintenance period."||||0.3458
91719956|NCT02030600|183332878|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDeg against IGlar was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%.|Treatment contrast|0.09|||||TWO_SIDED|95.0|-0.04|0.23||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a mixed model for repeated measurement (MMRM) with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.23|-0.04|
91719957|NCT02030600|183332878|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%|Treatment contrast|0.06|||||TWO_SIDED|95.0|-0.07|0.18||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a MMRM with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.18|-0.07|
91719958|NCT01107015|183332886|OTHER|Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10.||||||0.027||||||CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months.|Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation.||||0.027
91719959|NCT01107015|183332886|SUPERIORITY||Mean Difference (Net)|0.05||||0.001|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin.||||0.001
91719960|NCT01155323|183332887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.||0.23|-0.21|
91719961|NCT01155323|183332888|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.19|0.25|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.||0.25|-0.19|
91719962|NCT01155323|183332889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.22|0.22|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.||0.22|-0.22|
91719963|NCT01155323|183332890|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/-0.50|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.||0.01|-0.03|
91526996|NCT01036022|182929425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.2511|TWO_SIDED|95.0|-1.1|3.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 6 SCCAI score||3.9|-1.1|0.2511
91526997|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.24|2.39||||||Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels||2.39|0.24|
91526998|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.21|1.92||||||Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels||1.92|0.21|
91487701|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
91719964|NCT01155323|183332891|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.15|0.29|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.||0.29|-0.15|
91719965|NCT01155323|183332892|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/- 0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.||0.06|-0.01|
91719966|NCT01208051|183332896|SUPERIORITY|||||||0.26||||||p-value is stratified by randomization factors.|Log Rank|The conditional power was 7.8%, reaching the futility boundary of \<15%. Patients on the combination arm were then crossed over to cediranib alone.||||||0.26
91719967|NCT01208051|183332897|SUPERIORITY|||||||0.36|||||||Log Rank|||||||0.36
91719968|NCT01208051|183332899|SUPERIORITY|||||||0.8|||||||Log Rank|||||||0.80
91719969|NCT01208051|183332900|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
91719970|NCT00973973|183332911|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0262|TWO_SIDED|95.0|-0.45|-0.03|||ANCOVA|Analysis of covariance (ANCOVA) model including baseline value as a covariate.||Comparison of Change from Baseline at Week 4||-0.03|-0.45|0.0262
91719971|NCT00973973|183332911|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.152|<|0.0001|TWO_SIDED|95.0|-1.06|-0.46|||ANCOVA|Analysis of covariance (ANCOVA) model, including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.46|-1.06|< 0.0001
91719972|NCT00973973|183332913|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.0163|TWO_SIDED|95.0|-0.38|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.04|-0.38|0.0163
91719973|NCT00973973|183332913|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.101||0.0066|TWO_SIDED|95.0|-0.48|-0.08|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.08|-0.48|0.0066
91719974|NCT00973973|183332915|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.082||0.0089|TWO_SIDED|95.0|-0.38|-0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.06|-0.38|0.0089
91487702|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.28|-2.47|0.5976
91487703|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.71|-6.51|0.8979
91719975|NCT00973973|183332915|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.53|-0.14|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.14|-0.53|0.0011
91719976|NCT00973973|183332917|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.127||0.036|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change form baseline at week 4||-0.02|-0.52|0.0360
91719977|NCT00973973|183332917|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.137||0.007|TWO_SIDED|95.0|-0.65|-0.11|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.11|-0.65|0.0070
91719978|NCT00973973|183332923|SUPERIORITY||LS Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|3.939||0.0137|TWO_SIDED|95.0|-17.63|-2.05|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-2.05|-17.63|0.0137
91719979|NCT00973973|183332923|SUPERIORITY||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|3.913||0.0019|TWO_SIDED|95.0|-20.19|-4.7|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-4.70|-20.19|0.0019
91719980|NCT00973973|183332925|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|2.728||0.0244|TWO_SIDED|95.0|-11.61|-0.81|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.81|-11.61|0.0244
91487704|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 4 Day 28||2.48|-4.30|0.5976
91487705|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.91||||0.6669|TWO_SIDED|95.0|-3.23|5.05|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.05|-3.23|0.6669
91487706|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|-1.6||||0.6309|TWO_SIDED|95.0|-8.13|4.93|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.93|-8.13|0.6309
91487707|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|1.83||||0.4473|TWO_SIDED|95.0|-2.9|6.56|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.56|-2.90|0.4473
91487708|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|2.73||||0.3021|TWO_SIDED|95.0|-2.45|7.91|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.91|-2.45|0.3021
91487709|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|-1.6||||0.7134|TWO_SIDED|95.0|-10.14|6.94|||Cochran-Mantel-Haenszel|||Week 12, Day 84||6.94|-10.14|0.7134
91487710|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|3.7||||0.2635|TWO_SIDED|95.0|-2.79|10.19|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.19|-2.79|0.2635
91487711|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|4.55||||0.1749|TWO_SIDED|95.0|-2.02|11.11|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.11|-2.02|0.1749
91487712|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
91487713|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.31|-8.31|1.0000
91719981|NCT00973973|183332925|SUPERIORITY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|2.549||0.0141|TWO_SIDED|95.0|-11.39|-1.3|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-1.30|-11.39|0.0141
91719982|NCT00973973|183332927|SUPERIORITY||LS Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|1.821||0.0893|TWO_SIDED|95.0|-6.72|0.49|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||0.49|-6.72|0.0893
91719983|NCT00973973|183332927|SUPERIORITY||LS Mean Difference|-3.52|STANDARD_ERROR_OF_MEAN|1.938||0.072|TWO_SIDED|95.0|-7.35|0.32|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||0.32|-7.35|0.0720
91719984|NCT00973973|183332929|SUPERIORITY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.505|<|0.0001|TWO_SIDED|95.0|-3.26|-1.26|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of the change from baseline in CPSSS total score||-1.26|-3.26|< 0.0001
91686116|NCT03355469|183262990|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.96|TWO_SIDED|95.0|-0.059|0.062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.062|-0.059|0.960
91526999|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.26|2.48||||||Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels||2.48|0.26|
91527000|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels||2.68|0.27|
91527001|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.23|1.81||||||Placebo versus Asacol for Week 1 fecal calprotectin levels||1.81|0.23|
91686117|NCT03355469|183262990|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.075|TWO_SIDED|95.0|-0.109|0.006||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.006|-0.109|0.075
91686118|NCT03355469|183262990|SUPERIORITY||Mean Difference (Final Values)|-0.033||||0.258|TWO_SIDED|95.0|-0.094|0.028||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.028|-0.094|0.258
91686119|NCT03355469|183262990|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.443|TWO_SIDED|95.0|-0.075|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.075|0.443
91686120|NCT03355469|183262990|SUPERIORITY||Mean Difference (Final Values)|-0.053||||0.144|TWO_SIDED|95.0|-0.126|0.02||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.020|-0.126|0.144
91686121|NCT03355469|183262991|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.147|TWO_SIDED|95.0|-0.017|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.017|0.147
91686122|NCT03355469|183262991|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.943|TWO_SIDED|95.0|-0.016|0.017||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.017|-0.016|0.943
91686123|NCT03355469|183262991|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.108|TWO_SIDED|95.0|-0.027|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.027|0.108
91686124|NCT03355469|183262991|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.319|TWO_SIDED|95.0|-0.024|0.009||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.009|-0.024|0.319
91686125|NCT03355469|183262991|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.496|TWO_SIDED|95.0|-0.019|0.01||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.010|-0.019|0.496
91719985|NCT00973973|183332929|SUPERIORITY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.41|-0.69|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dysmenorrhea score||-0.69|-1.41|< 0.0001
91686126|NCT03355469|183262991|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.187|TWO_SIDED|95.0|-0.031|0.007||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.007|-0.031|0.187
91686127|NCT03355469|183262992|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.086|TWO_SIDED|95.0|-0.495|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.495|0.086
91686128|NCT03355469|183262992|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.608|TWO_SIDED|95.0|-0.354|0.574||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.574|-0.354|0.608
91686129|NCT03355469|183262992|SUPERIORITY||Mean Difference (Final Values)|-0.344||||0.11|TWO_SIDED|95.0|-0.779|0.09||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.090|-0.779|0.110
91686130|NCT03355469|183262992|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.145|TWO_SIDED|95.0|-0.818|0.137||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.137|-0.818|0.145
91686131|NCT03355469|183262992|SUPERIORITY||Mean Difference (Final Values)|-0.114||||0.565|TWO_SIDED|95.0|-0.538|0.309||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.309|-0.538|0.565
91719986|NCT00973973|183332929|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.143||0.0139|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of non-menstrual pelvic pain score||-0.07|-0.64|0.0139
91719987|NCT00973973|183332929|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.173||0.1052|TWO_SIDED|95.0|-0.63|0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dyspareunia score||0.06|-0.63|0.1052
91719988|NCT00973973|183332929|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.143||0.0081|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of pelvic tenderness score||-0.10|-0.67|0.0081
91719989|NCT00973973|183332929|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.125||0.024|TWO_SIDED|95.0|-0.53|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of induration score||-0.04|-0.53|0.0240
91686132|NCT03355469|183262992|SUPERIORITY||Mean Difference (Final Values)|-0.454||||0.11|TWO_SIDED|95.0|-1.025|0.116||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.116|-1.025|0.110
91686133|NCT02291510|183262993|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.4|||<|0.001|TWO_SIDED|90.0|32.27|38.74|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||38.74|32.27|<0.001
91686134|NCT02291510|183262993|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.3|||<|0.001|TWO_SIDED|90.0|47.77|57.36|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||57.36|47.77|<0.001
91719990|NCT00973973|183332931|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0012|TWO_SIDED|95.0|-1.2|-0.3|||ANOVA|||Comparison of Patient Global Impression of Change at week 4||-0.3|-1.2|0.0012
91487714|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.31|-8.31|1.0000
91487715|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
91487716|NCT02833350|182847902|SUPERIORITY||Adjusted Difference|1.37||||0.7848|TWO_SIDED|95.0|-8.46|11.2|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.20|-8.46|0.7848
91487717|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.28|6.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.28|-6.28|1.0000
91487718|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.93||||0.5941|TWO_SIDED|95.0|-2.5|4.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.37|-2.50|0.5941
91686135|NCT02291510|183262993|SUPERIORITY_OR_OTHER||% Ratio of LS Means|32.1|||<|0.001|TWO_SIDED|90.0|29.3|35.18|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||35.18|29.30|<0.001
91686136|NCT02291510|183262993|SUPERIORITY_OR_OTHER||% Ratio of LS Means|47.5|||<|0.001|TWO_SIDED|90.0|43.38|52.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||52.09|43.38|<0.001
91686137|NCT02291510|183262993|SUPERIORITY_OR_OTHER||% Ratio of LS Means|110.1||||0.0832|TWO_SIDED|90.0|100.5|120.68|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||120.68|100.50|0.0832
91686138|NCT02291510|183262994|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.9|||<|0.001|TWO_SIDED|90.0|32.43|39.77|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||39.77|32.43|<0.001
91686139|NCT02291510|183262994|SUPERIORITY_OR_OTHER||% Ratio of LS Means|53.0|||<|0.001|TWO_SIDED|90.0|47.88|58.71|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||58.71|47.88|<0.001
91719991|NCT00973973|183332931|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.5|-0.5|||ANOVA|||Comparison of Patient Global Impression of Change at week 8||-0.5|-1.5|0.0002
91719992|NCT00973973|183332933|SUPERIORITY||Difference|19.4||||0.0136|TWO_SIDED|95.0|4.4|34.4|||Pearson chi-squared|||Comparison of response rates at week 4||34.4|4.4|0.0136
91719993|NCT00973973|183332933|SUPERIORITY||Difference|30.2||||0.0007|TWO_SIDED|95.0|13.6|46.7|||Pearson chi-squared|||Comparison of response rates at week 8||46.7|13.6|0.0007
91719994|NCT02471339|183332939|SUPERIORITY|||||||0.05|||||||ANCOVA|||Analysis of covariance. Analyses for primary and secondary outcomes were two-tailed and alpha was set to 0.05. An a priori analysis suggested that, to detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group would be needed.||||0.05
91487719|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.93|2.93|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.93|-2.93|1.0000
91527002|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.26|2.73||||||Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels||2.73|0.26|
91686140|NCT02291510|183262994|SUPERIORITY_OR_OTHER||% Ratio of LS Means|45.3|||<|0.001|TWO_SIDED|90.0|40.88|50.13|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||50.13|40.88|<0.001
91686141|NCT02291510|183262994|SUPERIORITY_OR_OTHER||% Ratio of LS Means|66.8|||<|0.001|TWO_SIDED|90.0|60.34|74.0|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||74.00|60.34|<0.001
91719995|NCT02471339|183332940|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91719996|NCT02471339|183332943|SUPERIORITY|||||||0.05|||||||t-test|||||||.05
91719997|NCT02471339|183332947|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
91487720|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.17|6.17|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.17|-6.17|1.0000
91487721|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.95|2.95|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.95|-2.95|1.0000
91487722|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
91487723|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|-0.43||||0.8929|TWO_SIDED|95.0|-6.62|5.77|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.77|-6.62|0.8929
91487724|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|-0.13||||0.9424|TWO_SIDED|95.0|-3.78|3.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||3.51|-3.78|0.9424
91487725|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|-0.94||||0.5927|TWO_SIDED|95.0|-4.4|2.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||2.51|-4.40|0.5927
91487726|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|-0.46||||0.8788|TWO_SIDED|95.0|-6.31|5.4|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.40|-6.31|0.8788
91527003|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.55|||||TWO_SIDED|95.0|0.18|1.68||||||Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels||1.68|0.18|
91719998|NCT02110693|183333027|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.64|0.75||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.75|.64|
91719999|NCT02110693|183333027|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.74|||||TWO_SIDED|95.0|0.68|0.79||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.79|.68|
91686142|NCT02291510|183262994|SUPERIORITY_OR_OTHER||% Ratio of LS Means|79.3||||0.0004|TWO_SIDED|90.0|71.65|87.86|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||87.86|71.65|0.0004
91686143|NCT00459355|183263027|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<0.0001
91720000|NCT02110693|183333028|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.71|||||TWO_SIDED|95.0|0.63|0.79||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.79|.63|
91720001|NCT02110693|183333028|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.62|0.77||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.77|.62|
91720002|NCT02110693|183333029|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.57|||||TWO_SIDED|95.0|0.47|0.67||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.67|.47|
91487727|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.87||||0.6876|TWO_SIDED|95.0|-3.36|5.09|||Cochran-Mantel-Haenszel|||Week 8 Day 56||5.09|-3.36|0.6876
91527004|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.21|2.18||||||Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels||2.18|0.21|
91686144|NCT00459355|183263028|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<.0001
91686145|NCT00459355|183263029|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||MANCOVA|||||||.002
91487728|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.97||||0.6656|TWO_SIDED|95.0|-3.42|5.35|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.35|-3.42|0.6656
91487729|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|-0.46||||0.8787|TWO_SIDED|95.0|-6.34|5.42|||Cochran-Mantel-Haenszel|||Week 12 Day 84||5.42|-6.34|0.8787
91487730|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.74||||0.7101|TWO_SIDED|95.0|-3.17|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-3.17|0.7101
91487731|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|3.2||||0.2425|TWO_SIDED|95.0|-2.16|8.55|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.55|-2.16|0.2425
91487732|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.68|8.68|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.68|-8.68|1.0000
91487733|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.39|8.39|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.39|-8.39|1.0000
91487734|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|2.03||||0.6658|TWO_SIDED|95.0|-7.17|11.22|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.22|-7.17|0.6658
91527005|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.19|2.03||||||Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels||2.03|0.19|
91527006|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.22|1.9||||||Placebo versus Asacol for Week 2 fecal calprotectin levels||1.90|0.22|
91527007|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|1.07|||||TWO_SIDED|95.0|0.28|4.09||||||Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels||4.09|0.28|
91686146|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.1089|STANDARD_ERROR_OF_MEAN|0.212||0.6102|TWO_SIDED|90.0|-0.4656|0.2477|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2477|-0.4656|0.6102
91686147|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.1266|STANDARD_ERROR_OF_MEAN|0.2076||0.5452|TWO_SIDED|90.0|-0.4758|0.2225|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2225|-0.4758|0.5452
91686148|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.1682|STANDARD_ERROR_OF_MEAN|0.2055||0.4178|TWO_SIDED|90.0|-0.5139|0.1775|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.1775|-0.5139|0.4178
91686149|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.4885|STANDARD_ERROR_OF_MEAN|0.2075||0.0233|TWO_SIDED|90.0|-0.8375|-0.1395|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.1395|-0.8375|0.0233
91686150|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.0177|STANDARD_ERROR_OF_MEAN|0.2043||0.9314|TWO_SIDED|90.0|-0.3613|0.3259|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.3259|-0.3613|0.9314
91686151|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.0592|STANDARD_ERROR_OF_MEAN|0.2045||0.7734|TWO_SIDED|90.0|-0.4032|0.2847|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2847|-0.4032|0.7734
91686152|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.3796|STANDARD_ERROR_OF_MEAN|0.2043||0.0702|TWO_SIDED|90.0|-0.7232|-0.036|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0360|-0.7232|0.0702
91686153|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.0415|STANDARD_ERROR_OF_MEAN|0.1993||0.8359|TWO_SIDED|90.0|-0.3768|0.2937|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2937|-0.3768|0.8359
91686154|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.3619|STANDARD_ERROR_OF_MEAN|0.1988||0.0759|TWO_SIDED|90.0|-0.6962|-0.0275|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0275|-0.6962|0.0759
91720003|NCT02110693|183333029|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.6|||||TWO_SIDED|95.0|0.5|0.69||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.69|.50|
91686155|NCT01009814|183263031|OTHER||Mean Difference (Net)|-0.3203|STANDARD_ERROR_OF_MEAN|0.1993||0.1155|TWO_SIDED|90.0|-0.6555|0.0149|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.0149|-0.6555|0.1155
91686156|NCT00180661|183263092|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91686157|NCT00180661|183263093|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
91686158|NCT01495702|183263131|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.|Difference in proportions|5.3||||0.066|TWO_SIDED|95.0|-0.5|12.0|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||12.0|-0.5|0.066
91686159|NCT04152863|183263135|SUPERIORITY||Mean Difference (Net)|11.9||||0.1812|TWO_SIDED|90.0|-9.5|32.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||32.5|-9.5|0.1812
91686160|NCT04152863|183263135|SUPERIORITY||Mean Difference (Net)|4.8||||0.3548|TWO_SIDED|90.0|-16.2|25.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||25.5|-16.2|0.3548
91686161|NCT04152863|183263135|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|7.1|||||TWO_SIDED|90.0|-14.6|28.2||||||||28.2|-14.6|
91487735|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.77|8.77|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.77|-8.77|1.0000
91686162|NCT04152863|183263136|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.5|2.27||||||||2.27|0.50|
91720004|NCT02110693|183333030|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
91686163|NCT04152863|183263136|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.51|2.29||||||||2.29|0.51|
91686164|NCT04152863|183263136|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.04||||||||2.04|0.50|
91686165|NCT04152863|183263138|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
91686166|NCT04152863|183263138|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
91686167|NCT04152863|183263138|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|0.0|||||TWO_SIDED|90.0|-21.2|21.2||||||||21.2|-21.2|
91686168|NCT04152863|183263139|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.7|3.02||||||||3.02|0.70|
91686169|NCT04152863|183263139|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.62|2.68||||||||2.68|0.62|
91686170|NCT04152863|183263139|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.6|2.22||||||||2.22|0.60|
91686171|NCT04152863|183263141|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.71|3.79||||||||3.79|0.71|
91686172|NCT04152863|183263141|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.68||||||||2.68|0.47|
91686173|NCT04152863|183263141|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.64|3.02||||||||3.02|0.64|
91686174|NCT00919126|183263144|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.||The dose of propofol adjusted to BSA and maintenance duration was expected to be 4.0 mg/m².min in the control group, 2.8 mg/m².min in one xenon group and 3.0 mg/m².min in the other xenon group. With an expected common standard deviation of 2.0 mg/m².min, a type I error of 0.05 (two-sided) and a power of 0.80, the sample size required to show a statistically significant difference between the three groups was estimated to be 48 patients per group, resulting in a total of 144 randomised patients.||||<0.0001
91686175|NCT00919126|183263144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0256|||<|0.0001|TWO_SIDED|95.0|2.328|3.724||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Medical Air in Oxygen was assessed.|||3.724|2.328|<0.0001
91686176|NCT00919126|183263144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2905|||<|0.0001|TWO_SIDED|95.0|1.57|3.011||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 50% in Oxygen minus Medical Air in Oxygen was assessed.|||3.011|1.570|<0.0001
91686177|NCT00919126|183263144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7351||||0.0365|TWO_SIDED|95.0|0.038|1.432||Pairwise comparison was performed using the Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Xenon 50% in Oxygen was assessed|||1.432|0.038|0.0365
91720005|NCT02110693|183333030|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|Sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
91487736|NCT02833350|182847903|SUPERIORITY||Adjusted Difference|6.57||||0.2457|TWO_SIDED|95.0|-4.52|17.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||17.66|-4.52|0.2457
91487737|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-2.36||||0.496|TWO_SIDED|95.0|-6.73|2.02|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.02|-6.73|0.4960
91487738|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-2.18||||0.2736|TWO_SIDED|95.0|-5.34|0.98|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.98|-5.34|0.2736
91686178|NCT01644617|183263157|SUPERIORITY_OR_OTHER||Difference in Least Squares Means (LSM)|-3.62|||<|0.001|TWO_SIDED|95.0|-4.85|-2.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-2.39|-4.85|<0.001
91487739|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-3.08||||0.0608|TWO_SIDED|95.0|-6.26|0.1|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.10|-6.26|0.0608
91487740|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-1.25||||0.9237|TWO_SIDED|95.0|-6.02|3.52|||Cochran-Mantel-Haenszel|||Week 2, Day 14||3.52|-6.02|0.9237
91487741|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-3.14||||0.0893|TWO_SIDED|95.0|-6.6|0.33|||Cochran-Mantel-Haenszel|||Week 2, Day 14||0.33|-6.60|0.0893
91487742|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-4.07||||0.0138|TWO_SIDED|95.0|-7.51|-0.63|||Cochran-Mantel-Haenszel|||Week 2, Day 14||-0.63|-7.51|0.0138
91487743|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-3.22||||0.3358|TWO_SIDED|95.0|-8.24|1.8|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.80|-8.24|0.3358
91487744|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-4.57||||0.0078|TWO_SIDED|95.0|-8.2|-0.94|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.94|-8.20|0.0078
91527008|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.23|2.43||||||Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels||2.43|0.23|
91686179|NCT01644617|183263157|SUPERIORITY_OR_OTHER||Difference in LSM|-1.98||||0.003|TWO_SIDED|95.0|-3.24|-0.72|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.72|-3.24|0.003
91686180|NCT01644617|183263158|SUPERIORITY_OR_OTHER||Difference in LSM|-2.08|||<|0.001|TWO_SIDED|95.0|-3.14|-1.03|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.03|-3.14|<0.001
91686181|NCT01644617|183263158|SUPERIORITY_OR_OTHER||Difference in LSM|-1.23||||0.032||95.0|-2.36|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-2.36|0.032
91686182|NCT01644617|183263159|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.007|TWO_SIDED|95.0|-2.34|-0.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.39|-2.34|0.007
91686183|NCT01644617|183263159|SUPERIORITY_OR_OTHER||Difference in LSM|-0.54||||0.198|TWO_SIDED|95.0|-1.38|0.29|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.29|-1.38|0.198
91487745|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-4.68||||0.0059|TWO_SIDED|95.0|-8.3|-1.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.06|-8.30|0.0059
91487746|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-2.29||||0.6503|TWO_SIDED|95.0|-7.39|2.8|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.80|-7.39|0.6503
91487747|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-3.12||||0.1282|TWO_SIDED|95.0|-6.84|0.59|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.59|-6.84|0.1282
91487748|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-2.94||||0.1675|TWO_SIDED|95.0|-6.65|0.78|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.78|-6.65|0.1675
91487749|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-2.94||||0.422|TWO_SIDED|95.0|-7.96|2.09|||Cochran-Mantel-Haenszel|||Week 12, Day 84||2.09|-7.96|0.4220
91487750|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-5.1||||0.0027|TWO_SIDED|95.0|-8.77|-1.42|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.42|-8.77|0.0027
91686184|NCT01644617|183263160|SUPERIORITY_OR_OTHER||Difference in LSM|-4.84|||<|0.001|TWO_SIDED|95.0|-6.59|-3.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-3.09|-6.59|<0.001
91686185|NCT01644617|183263160|SUPERIORITY_OR_OTHER||Difference in LSM|-2.65||||0.003|TWO_SIDED|95.0|-4.35|-0.95|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.95|-4.35|0.003
91686186|NCT01644617|183263161|SUPERIORITY_OR_OTHER||Difference in LSM|-2.62|||<|0.001|TWO_SIDED|95.0|-4.12|-1.13|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.13|-4.12|<0.001
91686187|NCT01644617|183263161|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.091|TWO_SIDED|95.0|-2.96|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-2.96|0.091
91487751|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-5.47||||0.0011|TWO_SIDED|95.0|-9.15|-1.78|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.78|-9.15|0.0011
91686188|NCT01644617|183263162|SUPERIORITY_OR_OTHER||Difference in LSM|-1.97||||0.004|TWO_SIDED|95.0|-3.3|-0.64|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.64|-3.30|0.004
91686189|NCT01644617|183263162|SUPERIORITY_OR_OTHER||Difference in LSM|-0.83||||0.181|TWO_SIDED|95.0|-2.06|0.4|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.40|-2.06|0.181
91686190|NCT01644617|183263163|SUPERIORITY_OR_OTHER||Difference in LSM|-1.27|||<|0.001|TWO_SIDED|95.0|-1.92|-0.62|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.62|-1.92|<0.001
91686191|NCT01644617|183263163|SUPERIORITY_OR_OTHER||Difference in LSM|-0.77||||0.023|TWO_SIDED|95.0|-1.43|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-1.43|0.023
91686192|NCT01644617|183263164|SUPERIORITY_OR_OTHER||Difference in LSM|-0.53||||0.082|TWO_SIDED|95.0|-1.13|0.07|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.07|-1.13|0.082
91686193|NCT01644617|183263164|SUPERIORITY_OR_OTHER||Difference in LSM|-0.13||||0.691|TWO_SIDED|95.0|-0.79|0.52|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.52|-0.79|0.691
91686194|NCT01644617|183263165|SUPERIORITY_OR_OTHER||Difference in LSM|-0.61||||0.023|TWO_SIDED|95.0|-1.14|-0.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.09|-1.14|0.023
91686195|NCT01644617|183263165|SUPERIORITY_OR_OTHER||Difference in LSM|-0.34||||0.235|TWO_SIDED|95.0|-0.9|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-0.90|0.235
91686196|NCT01644617|183263168|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.55|||<|0.001|TWO_SIDED|95.0|0.43|0.68|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.68|0.43|<0.001
91686197|NCT01644617|183263168|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.52|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.52|0.33|<0.001
91686198|NCT01644617|183263168|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.52|||<|0.001|TWO_SIDED|95.0|0.41|0.64|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.64|0.41|<0.001
91686199|NCT01644617|183263168|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.39|||<|0.001|TWO_SIDED|95.0|0.3|0.48|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.48|0.30|<0.001
91686200|NCT01644617|183263169|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.13|<0.001
91686201|NCT01644617|183263169|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.25|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.25|0.12|<0.001
91487752|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|3.21||||0.0455|TWO_SIDED|95.0|0.05|6.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.37|0.05|0.0455
91527009|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.18|2.08||||||Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels||2.08|0.18|
91527010|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.17|2.08||||||Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels||2.08|0.17|
91527011|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.15|1.32||||||Placebo versus Asacol for Week 3 fecal calprotectin levels||1.32|0.15|
91686202|NCT01644617|183263169|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.42|0.23|<0.001
91686203|NCT01644617|183263169|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.16|<0.001
91686204|NCT01644617|183263170|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|12.4||||||95.0|-3.6|28.9|||||Analysis based on the Miettinen and Nurminen method|||28.9|-3.6|
91686205|NCT01644617|183263170|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|9.8|||||TWO_SIDED|95.0|-7.0|26.6|||||Analysis based on the Miettinen and Nurminen method|||26.6|-7.0|
91686206|NCT01644617|183263171|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-7.5|||||TWO_SIDED|95.0|-22.6|6.7|||||Analysis based on the Miettinen and Nurminen method|||6.7|-22.6|
91487753|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|2.31||||0.2309|TWO_SIDED|95.0|-0.87|5.48|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.48|-0.87|0.2309
91487754|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|3.27||||0.0698|TWO_SIDED|95.0|-0.18|6.72|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.72|-0.18|0.0698
91686207|NCT01644617|183263171|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-14.6|||||TWO_SIDED|95.0|-28.5|-5.4|||||Analysis based on the Miettinen and Nurminen method|||-5.4|-28.5|
91686208|NCT00719615|183263172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Only risk factors significant at the 0.10 level in univariate analysis were included in the multivariate model.|Fisher Exact|||Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.||||<0.05
91686209|NCT02995408|183263173|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.23|TWO_SIDED|95.0|-2.63|0.65||p-value was calculated|t-test, 2 sided|||||0.65|-2.63|.23
91686210|NCT02995408|183263174|SUPERIORITY||Mean Difference (Final Values)|5.78||||0.024|TWO_SIDED|95.0|0.78|10.78||.05 is the threshold for significance|t-test, 2 sided|||We examined between group (3RP treatment versus wait-list) differences in pre-post change scores of resiliency.||10.78|.78|0.024
91686211|NCT02995408|183263175|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.001|TWO_SIDED|95.0|3.45|12.12||p=.05 is the threshold for significance.|t-test, 2 sided|||||12.12|3.45|0.001
91686212|NCT03126435|183263195|SUPERIORITY|||||||0.6647|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.6647
91686213|NCT03126435|183263196|SUPERIORITY|||||||0.4345|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.4345
91686214|NCT03126435|183263197|SUPERIORITY|||||||0.2632|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records||||||0.2632
91686215|NCT03126435|183263199|SUPERIORITY|||||||0.1002|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.1002
91686216|NCT03126435|183263200|SUPERIORITY|||||||0.9882|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.9882
91527012|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|95.0|0.33|5.04||||||Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels||5.04|0.33|
91686217|NCT03971474|183263203|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.05|TWO_SIDED|80.0|0.51|0.92||If either P value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the standard stratified log-rank test.||0.92|0.51|0.05
91686218|NCT03971474|183263203|SUPERIORITY|||||||0.15||||||If either p-value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|||Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the weighted log-rank test.||||0.15
91686219|NCT03971474|183263204|SUPERIORITY|||||||0.19||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.19
91686220|NCT03971474|183263205|SUPERIORITY|||||||0.38||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.38
91686221|NCT03971474|183263208|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.25|TWO_SIDED|80.0|0.66|1.14|||Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of IA-PFS was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the standard stratified log-rank test.||1.14|0.66|0.25
91686222|NCT03971474|183263208|SUPERIORITY|||||||0.14|||||||Log Rank|Testing was performed using a weighted log-rank test.||Comparison of IA-PFS between the RP and SOC arms was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the weighted log-rank test.||||0.14
91686223|NCT03971474|183263209|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.16|TWO_SIDED|80.0|0.5|1.1||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.10|0.50|0.16
91686224|NCT03971474|183263209|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.08|TWO_SIDED|80.0|0.45|0.97||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.97|0.45|0.08
91686225|NCT03971474|183263209|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|80.0|0.28|0.65||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.65|0.28|0.005
91720006|NCT02110693|183333034|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.|Spearman Correlation|0.63|||||TWO_SIDED|95.0|0.59|0.66|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.66|.59|
91720007|NCT02110693|183333034|OTHER|The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.|Spearman Correlation|0.64|||||TWO_SIDED|95.0|0.61|0.68|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.68|.61|
91527013|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.2|2.02||||||Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels||2.02|0.20|
91527014|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.29|3.23||||||Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels||3.23|0.29|
91686226|NCT03971474|183263209|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.43|TWO_SIDED|80.0|0.67|1.35||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.35|0.67|0.43
91686227|NCT03971474|183263210|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.28|TWO_SIDED|80.0|0.58|1.22||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.22|0.58|0.28
91686228|NCT03971474|183263210|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.07|TWO_SIDED|80.0|0.48|0.95||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.95|0.48|0.07
91487755|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|2.33||||0.2851|TWO_SIDED|95.0|-1.09|5.76|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.76|-1.09|0.2851
91487756|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|4.29||||0.0131|TWO_SIDED|95.0|0.69|7.9|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.90|0.69|0.0131
91487757|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|4.18||||0.0161|TWO_SIDED|95.0|0.59|7.78|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.78|0.59|0.0161
91487758|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|3.85||||0.036|TWO_SIDED|95.0|0.18|7.51|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.51|0.18|0.0360
91686229|NCT03971474|183263210|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.02|TWO_SIDED|80.0|0.38|0.8||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.80|0.38|0.02
91487759|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|4.04||||0.0252|TWO_SIDED|95.0|0.37|7.7|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.70|0.37|0.0252
91527015|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|1.36|||||TWO_SIDED|95.0|0.39|4.72||||||Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels||4.72|0.39|
91686230|NCT03971474|183263210|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|80.0|0.69|1.29||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.29|0.69|0.41
91686231|NCT01023035|183263212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-8.6|7.2|||Mantel-Haenszel, modified Koch method|||The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.||7.2|-8.6|
91686232|NCT01807065|183263214|OTHER|||||||0.06|||||||Log Rank|||||||0.06
91686233|NCT02664181|183263236|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Partial remission rate was compared between both arms. The null hypothesis is that there is no difference in partial remission rate between the two arms, with a p-value of \< 0.05 indicating significance||||0.05
91686234|NCT02664181|183263237|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.13|1.21|||Log Rank|||||1.21|0.13|0.06
91686235|NCT02664181|183263238|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.19|TWO_SIDED|95.0|0.11|1.62|||Log Rank||Data from Kaplan-Meier analyses|||1.62|0.11|0.19
91527016|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.28|2.42||||||Placebo versus Asacol for Week 4 fecal calprotectin levels||2.42|0.28|
91686236|NCT00699816|183263240|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.01|TWO_SIDED|95.0|0.43|0.94|||Log Rank|||||0.94|0.43|0.01
91686237|NCT00699816|183263241|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.008|TWO_SIDED|95.0|0.06|0.75|||Log Rank|||||0.75|0.06|0.008
91686238|NCT00699816|183263242|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.19||||0.02|TWO_SIDED|95.0|0.04|0.87|||Log Rank|||||0.87|0.04|0.02
91686239|NCT03668808|183263256|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-140mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
91686240|NCT03668808|183263257|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-180mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
91686241|NCT03668808|183263258|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Mean ± SD CGM glucose (mg/dl) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
91686242|NCT03668808|183263259|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \<70 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
91487760|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|1.03||||0.9032|TWO_SIDED|95.0|-2.59|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-2.59|0.9032
91487761|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|0.66||||0.9791|TWO_SIDED|95.0|-2.97|4.3|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.30|-2.97|0.9791
91487762|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-3.22||||0.0927|TWO_SIDED|95.0|-6.98|0.54|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.54|-6.98|0.0927
91487763|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-2.12||||0.3202|TWO_SIDED|95.0|-6.33|2.09|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.09|-6.33|0.3202
91487764|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-4.2||||0.0476|TWO_SIDED|95.0|-8.36|-0.04|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.04|-8.36|0.0476
91487765|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-9.93|||<|0.0001|TWO_SIDED|95.0|-14.31|-5.55|||Cochran-Mantel-Haenszel|||Week 8, Day 54||-5.55|-14.31|<0.0001
91720008|NCT02110693|183333036|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.|Spearman Correlation|0.29|||||TWO_SIDED|95.0|0.25|0.33|||||The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.||.33|.25|
91720009|NCT02110693|183333036|OTHER||Spearman Correlation|0.28|||||TWO_SIDED|95.0|0.24|0.32|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.32|.24|
91720010|NCT02110693|183333037|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.|Spearman Correlation|0.42|||||TWO_SIDED|95.0|0.35|0.48|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.48|.35|
91720011|NCT02110693|183333037|OTHER||Spearman Correlation|0.4|||||TWO_SIDED|95.0|0.33|0.46|||||The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.|||.46|.33|
91720012|NCT02054156|183333055|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.83|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||0.83|0.37|0.0043
91720013|NCT02054156|183333056|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9915|TWO_SIDED|95.0|0.64|1.55|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||1.55|0.64|0.9915
91720014|NCT02054156|183333057|SUPERIORITY||Difference in % of Participants with SAE|-2.5||||0.7531|TWO_SIDED|95.0|-13.7|8.7|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||8.7|-13.7|0.7531
91487766|NCT02833350|182847904|SUPERIORITY||Adjusted Difference|-8.23||||0.0003|TWO_SIDED|95.0|-12.56|-3.9|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-3.90|-12.56|0.0003
91720015|NCT02054156|183333057|SUPERIORITY||Difference in % of Participants with AE|4.4||||0.3593|TWO_SIDED|95.0|-3.5|12.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson.|||12.6|-3.5|0.3593
91720016|NCT02054156|183333058|SUPERIORITY||Rate Ratio|0.86||||0.0004|TWO_SIDED|95.0|0.8|0.94|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||0.94|0.80|0.0004
91720017|NCT02054156|183333058|SUPERIORITY||Rate Ratio|1.25||||0.2098|TWO_SIDED|95.0|0.88|1.78|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||1.78|0.88|0.2098
91720018|NCT04154956|183333059|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.8204|TWO_SIDED|95.0|0.864|1.512||One-sided significance level was 0.01|Log Rank||Hazard ratio and confidence intervals (CIs) were computed from a stratified Cox model according to stratification factors as per IRT.|||1.512|0.864|0.8204
91720019|NCT04154956|183333060|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.112|TWO_SIDED|95.0|0.644|1.109||One-sided significance level was 0.00174.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.109|0.644|0.1120
91487767|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
91487768|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
91487769|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.28|-2.47|0.5976
91487770|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
91487771|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
91487772|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
91487773|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
91487774|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
91720020|NCT04154956|183333061|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6972|TWO_SIDED|95.0|0.55|1.42||P-value is provided for information only, there is no statistical inference based on this P-value.|Cochran-Mantel-Haenszel||Odds ratio and its 2-sided CI were provided from a Cochran-Mantel-Haenszel (CMH) test stratified according to the stratification factors.|||1.42|0.55|0.6972
91720021|NCT04154956|183333062|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0157|TWO_SIDED|95.0|0.546|0.972||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.972|0.546|0.0157
91487775|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
91487776|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
91487777|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
91487778|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|5.45||||0.0286|TWO_SIDED|95.0|0.57|10.34|||Cochran-Mantel-Haenszel|||Week 8, Day 56||10.34|0.57|0.0286
91720022|NCT04154956|183333063|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0002|TWO_SIDED|95.0|0.388|0.763||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.763|0.388|0.0002
91720023|NCT04154956|183333064|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0305|TWO_SIDED|95.0|0.533|1.014||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.014|0.533|0.0305
91720024|NCT04810962|183333079|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720025|NCT04810962|183333080|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720026|NCT04810962|183333082|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720027|NCT04810962|183333083|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720028|NCT04810962|183333084|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91487779|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
91487780|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|4.57||||0.0708|TWO_SIDED|95.0|-0.39|9.52|||Cochran-Mantel-Haenszel|||Week 12, Day 84||9.52|-0.39|0.0708
91487781|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|5.45||||0.0478|TWO_SIDED|95.0|0.05|10.86|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.86|0.05|0.0478
91487782|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
91487783|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
91527017|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.61|||||TWO_SIDED|95.0|0.14|2.66||||||Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels||2.66|0.14|
91686243|NCT03668808|183263260|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time 70-180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
91686244|NCT03668808|183263261|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \>180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
91686245|NCT03668808|183263262|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM - Coefficient of Variation (CV) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
91686246|NCT03668808|183263263|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM Fasting Blood Glucose (FBG) at 0600 local time at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
91720029|NCT04810962|183333085|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720030|NCT04810962|183333086|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720031|NCT04810962|183333087|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720032|NCT04810962|183333088|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720033|NCT04810962|183333089|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720034|NCT04810962|183333090|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.4|-1.0|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.0|-1.4|<0.001
91720035|NCT04810962|183333091|SUPERIORITY||Mean Difference (Net)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.7|<0.001
91720036|NCT04810962|183333092|SUPERIORITY||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.5|<0.001
91720037|NCT04810962|183333093|SUPERIORITY||Mean Difference (Net)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.02|-0.07|<0.001
91720038|NCT04810962|183333094|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.1|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.10|<0.001
91487784|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
91720039|NCT04810962|183333095|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.11|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.11|<0.001
91720040|NCT04810962|183333096|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91720041|NCT01348269|183333098|OTHER|T-test (with MITT, omitting outlier value of one patient in placebo group)|||||=|0.006|||||||t-test, 2 sided|||||||=0.006
91720042|NCT01348269|183333098|OTHER|Mann-Whitney-Test|||||=|0.015|||||||Wilcoxon (Mann-Whitney)|||||||=0.015
91720043|NCT00920816|183333127|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.767|||||TWO_SIDED|95.0|0.559|1.053||||||First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).||1.053|0.559|
91720044|NCT00920816|183333128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731|||||TWO_SIDED|95.0|0.506|1.058||||||Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).||1.058|0.506|
91720045|NCT03185208|183333143|SUPERIORITY||treatment x time interaction coefficient|0.69||||0.048|TWO_SIDED||||||Mixed Models Analysis|||||||0.048
91720046|NCT03185208|183333144|SUPERIORITY||treatment x time interaction coefficient|-0.08835||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
91720047|NCT03185208|183333145|SUPERIORITY||treatment x time interaction coefficient|0.08738||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
91527018|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.35|4.38||||||Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels||4.38|0.35|
91720048|NCT03185208|183333147|SUPERIORITY||treatment x time interaction coefficient|0.012||||0.93|TWO_SIDED||||||Mixed Models Analysis|||||||0.93
91720049|NCT03185208|183333148|SUPERIORITY||treatment x time interaction coefficient|-351.8||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
91720050|NCT03185208|183333149|SUPERIORITY||treatment x time interaction coefficient|58.95||||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
91720051|NCT05824026|183333207|OTHER||||||||||||||||||"The purpose of the primary analysis was to show non-inferiority to the performance of a historical control (a silver containing gelling fiber) on proportion of wounds healed, 77%, with a non-inferiority margin of 20%. Non-inferiority was demonstrated if the lower limit of the 95% confidence interval is above 57%. An exact confidence interval for the proportion was applied. In the primary analysis missing data was not included. In the post hoc sensitivity analysis missing data was imputed using multiple imputation for 3 wounds where data was assumed to be missing at random, and otherwise imputed as wound not healed.~The supplemental analysis addressed a more conservative analysis than performed for the historical control. Hence, no formal non-inferiority criteria was applied for this analysis."|||
91720052|NCT01129128|183333217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-173.0||||0.87|TWO_SIDED|95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.87
91720053|NCT01129128|183333217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|705.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.82
91720054|NCT01129128|183333218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15793.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.82
91720055|NCT01129128|183333218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23472.0||||0.68||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.68
91720056|NCT01129128|183333219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0||||0.9||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.90
91720057|NCT01129128|183333219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0||||0.76||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.76
91720058|NCT01129128|183333220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.98||95.0|||||Regression, Linear|controlled for baseline levels||||||0.98
91720059|NCT01129128|183333220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.0||||0.34||95.0|||||Regression, Linear|controlled for baseline levels||||||0.34
91720060|NCT01311661|183333231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.152|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.152|<0.0001
91527019|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.2|2.47||||||Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels||2.47|0.20|
91527020|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.46||||||Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels||1.46|0.11|
91720061|NCT01311661|183333231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.111|0.189|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.189|0.111|<0.0001
91720062|NCT01311661|183333231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.19|0.266|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.266|0.190|<0.0001
91720063|NCT01311661|183333231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.17|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.170|<0.0001
91720064|NCT01311661|183333232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.150|<0.0001
91720065|NCT01311661|183333232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.121|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.199|0.121|<0.0001
91720066|NCT01311661|183333232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.175|0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.253|0.175|<0.0001
91720067|NCT01311661|183333232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.181|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.258|0.181|<0.0001
91720068|NCT01311661|183333233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.153|0.238|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.238|0.153|<0.0001
91720069|NCT01311661|183333233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.187|0.102|<0.0001
91720070|NCT01311661|183333233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.2|0.285|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.285|0.200|<0.0001
91720071|NCT01311661|183333233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.156|0.241|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.241|0.156|<0.0001
91487785|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|4.11||||0.3838|TWO_SIDED|95.0|-5.14|13.36|||Cochran-Mantel-Haenszel|||Week 8, Day 56||13.36|-5.14|0.3838
91487786|NCT02833350|182847905|SUPERIORITY||Adjusted Difference|0.68||||0.9009|TWO_SIDED|95.0|-10.1|11.47|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.47|-10.10|0.9009
91487787|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-2.36||||0.5455|TWO_SIDED|95.0|-7.0|2.27|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.27|-7.00|0.5455
91487788|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-1.97||||0.4114|TWO_SIDED|95.0|-5.3|1.36|||Cochran-Mantel-Haenszel|||Week 1, Day 7||1.36|-5.30|0.4114
91487789|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-2.62||||0.1739|TWO_SIDED|95.0|-5.97|0.72|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.72|-5.97|0.1739
91487790|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-0.94||||0.9761|TWO_SIDED|95.0|-5.93|4.06|||Cochran-Mantel-Haenszel|||Week 2, Week 14||4.06|-5.93|0.9761
91487791|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.18||||0.0998|TWO_SIDED|95.0|-6.78|0.41|||Cochran-Mantel-Haenszel|||Week 2, Week 14||0.41|-6.78|0.0998
91487792|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.97||||0.0239|TWO_SIDED|95.0|-7.54|-0.39|||Cochran-Mantel-Haenszel|||Week 2, Week 14||-0.39|-7.54|0.0239
91487793|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.98||||0.2018|TWO_SIDED|95.0|-9.25|1.3|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.30|-9.25|0.2018
91487794|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-5.67||||0.0011|TWO_SIDED|95.0|-9.48|-1.87|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.87|-9.48|0.0011
91487795|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-5.27||||0.0026|TWO_SIDED|95.0|-9.06|-1.48|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.48|-9.06|0.0026
91487796|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-2.47||||0.6336|TWO_SIDED|95.0|-7.84|2.9|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.90|-7.84|0.6336
91487797|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.49||||0.095|TWO_SIDED|95.0|-7.38|0.41|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.41|-7.38|0.0950
91720072|NCT01311661|183333234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.138|0.228|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.228|0.138|<0.0001
91720073|NCT01311661|183333234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.108|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.198|0.108|<0.0001
91720074|NCT01311661|183333234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.222|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.177|0.267|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.267|0.177|<0.0001
91720075|NCT01311661|183333234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.165|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.165|<0.0001
91720076|NCT01311661|183333235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.109|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.203|0.109|<0.0001
91720077|NCT01311661|183333235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.054|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.054|<0.0001
91720078|NCT01311661|183333235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.149|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.243|0.149|<0.0001
91720079|NCT01311661|183333235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.125|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.125|<0.0001
91720080|NCT01311661|183333236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.091|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.180|0.091|<0.0001
91720081|NCT01311661|183333236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.078|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.167|0.078|<0.0001
91720082|NCT01311661|183333236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.186|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.186|0.098|<0.0001
91720083|NCT01311661|183333236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.103|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.191|0.103|<0.0001
91720084|NCT01311661|183333237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.11|0.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.206|0.110|<0.0001
91720085|NCT01311661|183333237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.185|0.090|<0.0001
91720086|NCT01311661|183333237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.123|0.218|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.218|0.123|<0.0001
91487798|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.18||||0.1451|TWO_SIDED|95.0|-7.06|0.71|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.71|-7.06|0.1451
91720087|NCT01311661|183333237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.087|<0.0001
91720088|NCT01311661|183333238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.188|0.102|<0.0001
91720089|NCT01311661|183333238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.085|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.171|0.085|<0.0001
91720090|NCT01311661|183333238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.113|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.198|0.113|<0.0001
91487799|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.28||||0.3434|TWO_SIDED|95.0|-8.43|1.87|||Cochran-Mantel-Haenszel|||Week 12, Day 84||1.87|-8.43|0.3434
91527021|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.15|1.48||||||Placebo versus Asacol for Week 5 fecal calprotectin levels||1.48|0.15|
91720091|NCT01311661|183333238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.098|<0.0001
91487800|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-5.45||||0.0016|TWO_SIDED|95.0|-9.23|-1.68|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.68|-9.23|0.0016
91487801|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-5.88||||0.0006|TWO_SIDED|95.0|-9.65|-2.1|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-2.10|-9.65|0.0006
91487802|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|4.64||||0.0025|TWO_SIDED|95.0|1.31|7.96|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.96|1.31|0.0025
91487803|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|3.98||||0.0129|TWO_SIDED|95.0|0.64|7.32|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.32|0.64|0.0129
91487804|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|4.04||||0.0206|TWO_SIDED|95.0|0.46|7.62|||Cochran-Mantel-Haenszel|||Week 2, Day 14||7.62|0.46|0.0206
91686247|NCT03668808|183263264|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in Liverpool Jet-Lag Questionnaire after 24 and 48 hours at the destination, whether after Eastward travel or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.01
91686248|NCT03668808|183263265|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Sleep quantity measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
91686249|NCT03668808|183263266|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is there was no difference in Sleep efficiency measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
91686250|NCT01252277|183263371|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91686251|NCT01252277|183263372|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.021
91686252|NCT01252277|183263373|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91686253|NCT01252277|183263374|SUPERIORITY_OR_OTHER|||||||0.48||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.48
91686254|NCT00345631|183263452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.68|||<|0.0001|TWO_SIDED|95.0|-19.04|-12.31||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis: The mean time to hemostasis for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-12.31|-19.04|<0.0001
91686255|NCT00345631|183263453|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.7||||0.0028|TWO_SIDED|95.0|-5.53|-1.87||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis:The mean time to ambulation for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-1.87|-5.53|0.0028
91686256|NCT00345631|183263454|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is adequate to rule out a 4% or larger disadvantage for VCD vs. MC (null hypothesis: 2.5% MC vs. 6.5% VCD) in the incidence of major complications for VCD vs. MC using a 95% upper confidence bound for the VCD - MC difference with 80% power and a 5% one-sided Type I error|Mean Difference (Final Values)|0.0||||0.0006|ONE_SIDED|95.0||1.14||P-value was calculated using unconditional exact test of non-inferiority for difference of two binomial proportions (VCD vs. MC) with a margin of 4%.|unconditional exact test|||Based on pre-planned hypotheses, a minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) would demonstrate non-inferiority for the primary safety endpoint and superiority for both co-primary effectiveness endpoints in comparing VCD vs. MC.||1.14||0.0006
91686257|NCT00345631|183263455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.154|TWO_SIDED|95.0|-7.84|0.45|||t-test, 2 sided|||Null hypothesis: The mean time to eligibility for hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||0.45|-7.84|0.1540
91686258|NCT00345631|183263456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.3612|TWO_SIDED|95.0|-7.46|2.31|||t-test, 2 sided|||Null hypothesis: The mean time to hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||2.31|-7.46|0.3612
91686259|NCT00345631|183263459|SUPERIORITY_OR_OTHER||Proportion difference|0.7||||0.85|TWO_SIDED|95.0|-4.8|7.4|||t-test, 2 sided|||Null hypothesis: The percentages of patients achieving procedure success between the vascular closure device and manual compression arms are equal.||7.4|-4.8|0.85
91686260|NCT00517556|183263461|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91686261|NCT01906515|183263468|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91686262|NCT01906515|183263469|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91686263|NCT02969382|183263654|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.23||0.001|TWO_SIDED|95.0|-11.9|-3.0|||Mixed Models Analysis|||||-3.0|-11.9|0.001
91527022|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.13|3.39||||||Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels||3.39|0.13|
91686264|NCT02969382|183263655|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
91686265|NCT02969382|183263656|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.71||0.019|TWO_SIDED|95.0|-3.1|-0.3|||Mixed Models Analysis|||||-0.3|-3.1|0.019
91686266|NCT02969382|183263657|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.55||0.008|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||||-0.4|-2.6|0.008
91686267|NCT02969382|183263658|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-6.6|-2.0|||Mixed Models Analysis|||||-2.0|-6.6|<0.001
91686268|NCT02969382|183263659|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.26|<|0.001|TWO_SIDED|95.0|-6.8|-1.8|||Mixed Models Analysis|||||-1.8|-6.8|<0.001
91527023|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.11|1.84||||||Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels||1.84|0.11|
91686269|NCT02969382|183263660|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.02|TWO_SIDED|95.0|-3.2|-0.3|||Mixed Models Analysis|||||-0.3|-3.2|0.020
91686270|NCT02969382|183263661|SUPERIORITY||Odds Ratio (OR)|2.645||||0.002|TWO_SIDED|95.0|1.422|4.921|||Regression, Logistic|||||4.921|1.422|0.002
91686271|NCT02969382|183263663|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
91686272|NCT02969382|183263664|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91686273|NCT02969382|183263665|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
91686274|NCT02839772|183263869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.581|STANDARD_ERROR_OF_MEAN|0.296|<|0.001|TWO_SIDED|95.0|0.997|2.164|||Mixed Models Analysis|t=5.341, df=89.347||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions."||2.164|0.997|<0.001
91686275|NCT02839772|183263870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|STANDARD_ERROR_OF_MEAN|0.346|<|0.001|TWO_SIDED|95.0|1.002|2.367|||Mixed Models Analysis|t=4.871, df=189.789||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||2.367|1.002|<0.001
91686276|NCT02839772|183263871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.386|<|0.001|TWO_SIDED|95.0|1.21|2.731|||Mixed Models Analysis|t=5.111, df=189.620||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions."||2.731|1.210|<0.001
91686277|NCT02839772|183263872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.751|STANDARD_ERROR_OF_MEAN|0.39||0.002|TWO_SIDED|95.0|0.656|2.846|||Mixed Models Analysis|t=3.154, df=189.580||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions."||2.846|0.656|0.002
91686278|NCT02839772|183263873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075|STANDARD_ERROR_OF_MEAN|0.515|<|0.001|TWO_SIDED|95.0|-3.042|-1.1078|||Mixed Models Analysis|t=-4.236,df=165.310||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions."||-1.1078|-3.042|<0.001
91527024|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.09|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels||1.48|0.09|
91527025|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.19|2.99||||||Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels||2.99|0.19|
91686279|NCT02839772|183263874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.658|STANDARD_ERROR_OF_MEAN|0.467|<|0.001|TWO_SIDED|95.0|-2.581|-0.736|||Mixed Models Analysis|t=-3.549, df=180.923||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||-0.736|-2.581|<0.001
91686280|NCT02839772|183263875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.641|STANDARD_ERROR_OF_MEAN|0.473||0.001|TWO_SIDED|95.0|-2.574|-0.708|||Mixed Models Analysis|t=-3.471, df=186.308||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions."||-0.708|-2.574|0.001
91686281|NCT02839772|183263876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.041|STANDARD_ERROR_OF_MEAN|0.572|<|0.001|TWO_SIDED|95.0|-3.168|-0.911|||Mixed Models Analysis|t=-3.565, df=186.739||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions."||-0.911|-3.168|<0.001
91686282|NCT02839772|183263877|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.452|STANDARD_ERROR_OF_MEAN|0.255||0.076|TWO_SIDED|95.0|-0.048|0.952||A cumulative logistic link function was used|Generalized estimating equation analysis|Wald Chi squared=3.138, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit."||0.952|-0.048|0.076
91720092|NCT01311661|183333239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.084|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.187|0.084|<0.0001
91686283|NCT02839772|183263878|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.224||||0.527|TWO_SIDED|95.0|-0.469|0.917||A Bernouilli distribution with a logistic link function was used.|Generalized estimating equation analysis|Wald chi-square=0.410, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit."||0.917|-0.469|0.527
91720093|NCT01311661|183333239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.073|<0.0001
91720094|NCT01311661|183333239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.093|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.195|0.093|<0.0001
91686284|NCT02839772|183263879|SUPERIORITY_OR_OTHER||Odds Ratio, log|-1.29|STANDARD_ERROR_OF_MEAN|0.446||0.031|TWO_SIDED|95.0|-2.161|-0.411||A Bernouilli distribution with a logistic link function was used|Generalized estimating equation analysis|Wald chi-square=8.304, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life."||-0.411|-2.161|0.031
91686285|NCT02839772|183263880|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.062|STANDARD_ERROR_OF_MEAN|0.741||0.005|TWO_SIDED|95.0|0.61|3.514||A Poisson distribution with a logarithmic link function was used|Generalized estimating equation analysis|Wald chi-square=7.745, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit."||3.514|0.610|0.005
91686286|NCT02839772|183263881|SUPERIORITY_OR_OTHER||Group ratio estimate|2.09|STANDARD_ERROR_OF_MEAN|1.102||0.058|TWO_SIDED|0.058|-0.069|4.25||A Poisson distribution with a logarithmic link function was used.|Generalized estimation equation|df=1|Those in the experimental group were expected to have fewer work days lost due to ADL.|"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL."||4.250|-0.069|0.058
91686287|NCT02839772|183263882|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value was \< 0.001 at all time points.|Spearman's correlation coefficient|The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.||The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.||||<0.001
91686288|NCT02839772|183263883|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.204||0.158|TWO_SIDED|95.0|-0.113|0.69|||Mixed Models Analysis|df=185.386||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease."||0.690|-0.113|0.158
91686289|NCT02839772|183263884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|0.255|0.895|||Mixed Models Analysis|df=169.916, t=3.550||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease."||0.895|0.255|<0.001
91686290|NCT02839772|183263885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.54||0.907|TWO_SIDED|95.0|-1.129|1.002|||Mixed Models Analysis|t=-0.117, df=178.814||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation.."||1.002|-1.129|0.907
91686291|NCT01569295|183263886|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.27|0.45|||Stratified log-rank test||Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.|||0.45|0.27|< 0.0001
91686292|NCT01569295|183263887|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|1.98|4.62||Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).|Cochran-Mantel-Haenszel|||||4.62|1.98|<0.0001
91720095|NCT01311661|183333239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.177|0.075|<0.0001
91487805|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|3.26||||0.0841|TWO_SIDED|95.0|-0.3|6.82|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.82|-0.30|0.0841
91720096|NCT01311661|183333240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.028||0.0001||95.0|0.055|0.165|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.165|0.055|0.0001
91686293|NCT01569295|183263888|SUPERIORITY||Odds Ratio (OR)|28.81|||<|0.0001|TWO_SIDED|95.0|10.5|79.02||Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||79.02|10.50|<0.0001
91487806|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|4.67||||0.0088|TWO_SIDED|95.0|0.91|8.42|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.42|0.91|0.0088
91686294|NCT01569295|183263889|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.098|TWO_SIDED|95.0|0.59|1.03|||Stratified log-rank test|||||1.03|0.59|0.098
91686295|NCT01569295|183263890|SUPERIORITY||Odds Ratio (OR)|9.55||||0.011|TWO_SIDED|95.0|1.19|76.81||Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||76.81|1.19|0.011
91686296|NCT01895777|183263896|NON_INFERIORITY|Non-inferiority margin of 20%|Difference in Rates|-0.038|||=|0.0001|TWO_SIDED|90.0|-0.141|0.066||p-value for non-inferiority is actually \<0.0001|Cochran-Mantel-Haenszel||Difference in rates (SOC - DE)|The primary analysis of the primary efficacy endpoint used the randomised set, following the intention-to-treat principle, based on adjudication-confirmed data. Age group was used as stratification factor using a Mantel-Haenszel type weighted average of differences.||0.066|-0.141|= 0.0001
91686297|NCT01895777|183263897|OTHER||Kaplan-Meier estimate|0.0|||||TWO_SIDED|90.0|-0.032|0.032|||Kaplan-Meier estimate||Kaplan-Meier estimate of rate difference.|Time-to event endpoint using Kaplan-Meier estimates based on adjudication-confirmed data. Due to the low event rate of major bleeding, age group stratification was not considered.||0.032|-0.032|
91686298|NCT01895777|183263903|OTHER||Hazard Ratio (HR)|1.145|||||TWO_SIDED|90.0|0.736|1.78||||||Any bleeding events was analysed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model and age group as the stratification factor. A pooling of age groups was performed as no events were observed in certain age group.||1.780|0.736|
91686299|NCT01895777|183263904|OTHER||Hazard Ratio (HR)|69990000.0||||0.9976|TWO_SIDED|90.0|0.0|999999999.0|||Cox proportional hazard model||Upper Limit of the 90% confidence interval was not assessable|All-cause mortality was analyzed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model.||999999999|0.000|0.9976
91686300|NCT02064296|183263913|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain.||||0.3330
91686301|NCT02064296|183263913|SUPERIORITY|||||||0.6474|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Healthy controls||||0.6474
91686302|NCT02064296|183263913|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain||||<0.0001
91686303|NCT02064296|183263913|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Fibromyalgia patients||||0.0004
91686304|NCT02064296|183263914|SUPERIORITY|||||||0.0653|||||||t-test, 2 sided|||This is a comparison of Mock Laser Acupuncture pre-and post 4 weeks of treatment.||||0.0653
91686305|NCT02064296|183263914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||This is a P value for the change in Traditional Acupuncture, pre and post 4 weeks of treatment.||||<0.0001
91686306|NCT02064296|183263915|SUPERIORITY|||||||0.7399|||||||t-test, 2 sided|||Glx statistical comparison||||0.7399
91686307|NCT02064296|183263915|SUPERIORITY|||||||0.6226|||||||t-test, 2 sided|||Glx statistical comparison||||0.6226
91686308|NCT02064296|183263916|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||GABA statistical comparison||||0.6344
91686309|NCT02064296|183263916|SUPERIORITY|||||||0.7985|||||||t-test, 2 sided|||GABA statistical comparison||||0.7985
91686310|NCT01406444|183263946|SUPERIORITY|||||||0.03|||||||Linear random effects model|||||||0.03
91686311|NCT01406444|183263947|SUPERIORITY|||||||0.002|||||||Linear random effects model|||||||0.002
91686312|NCT01406444|183263947|SUPERIORITY|||||||0.04|||||||Linear random effects model|||||||0.04
91686313|NCT02800642|183263969|OTHER||||||<|0.0001|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a ≥ 15-letter gain in BCVA at Week 76 is ≤ 40% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||<0.0001
91686314|NCT02800642|183263970|OTHER||||||=|0.8822|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a mean treatment interval of ≥ 8 weeks is ≤ 50% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||=0.8822
91686315|NCT02027428|183263978|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.3486|TWO_SIDED|95.0|0.61|1.19||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.19|0.61|0.3486
91720097|NCT01311661|183333240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.028||0.001||95.0|0.037|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.037|0.0010
91720098|NCT01311661|183333240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.063|0.172|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.172|0.063|<0.0001
91487807|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|5.07||||0.0034|TWO_SIDED|95.0|1.34|8.81|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.81|1.34|0.0034
91487808|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|4.55||||0.0138|TWO_SIDED|95.0|0.71|8.39|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.39|0.71|0.0138
91487809|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|4.85||||0.0073|TWO_SIDED|95.0|1.02|8.69|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.69|1.02|0.0073
91487810|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|1.29||||0.8284|TWO_SIDED|95.0|-2.46|5.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.03|-2.46|0.8284
91686316|NCT02027428|183263979|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0365|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0365
91686317|NCT02027428|183263980|SUPERIORITY||Overall response rate ratio|1.2||||0.087|TWO_SIDED|95.0|0.948|1.519||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|Cochran-Mantel-Haenszel||response ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. The rate ratio and its 95% CI were based on the non-stratified analysis.||1.519|0.948|0.0870
91686318|NCT02027428|183263981|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4164|TWO_SIDED|95.0|0.62|1.22||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.22|0.62|0.4164
91686319|NCT02027428|183263982|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0381|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0381
91686320|NCT02027428|183263983|SUPERIORITY||Overall response rate ratio|3.15||||0.0978|TWO_SIDED|95.0|0.733|13.574||5% level of significance.|Cochran-Mantel-Haenszel||Response rate ratio: nab-paclitaxel + BSC / BSC Alone|||13.574|0.733|0.0978
91686321|NCT02027428|183263984|SUPERIORITY||disease control rate ratio|0.99|||||TWO_SIDED|95.0|0.978|1.007|||||Disease control rate ratio: nab-paclitaxel + BSC / BSC Alone|The rate ratio and its 95% confidence interval are based on non-stratified analysis.||1.007|0.978|
91686322|NCT02027428|183263986|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.59|1.47|||||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|Hazard ratio was based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.47|0.59|
91686323|NCT01307748|183263997|OTHER|||||||0.005||||||The p value was adjusted for multiple comparisons using false discovery rate.|ANCOVA|Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.||The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.||||.005
91686324|NCT01307748|183263999|OTHER|||||||0.01||||||P value was adjusted for multiple comparisons using false discovery rate|ANCOVA|A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.||||||.01
91686325|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.23||||0.001|TWO_SIDED|95.0|2.04|5.13|||t-test, 2 sided|||Sevoflurane administration in developing postoperative headache||5.13|2.04|0.001
91686326|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.006|TWO_SIDED|95.0|1.19|2.84|||t-test, 2 sided|||Smoking as a factor for developing postoperative headache||2.84|1.19|0.006
91720099|NCT01311661|183333240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.057|0.166|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.166|0.057|<0.0001
91720100|NCT01311661|183333241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.5|0.757|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.757|0.500|<0.0001
91487811|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|0.86||||0.9525|TWO_SIDED|95.0|-2.88|4.6|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.60|-2.88|0.9525
91487812|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-3.22||||0.0856|TWO_SIDED|95.0|-6.91|0.46|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.46|-6.91|0.0856
91487813|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-2.08||||0.3374|TWO_SIDED|95.0|-6.36|2.2|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.20|-6.36|0.3374
91487814|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-4.24||||0.0534|TWO_SIDED|95.0|-8.53|0.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||0.06|-8.53|0.0534
91487815|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.33|-6.32|||Cochran-Mantel-Haenszel|||Week 8, Day 56||-6.32|-15.33|<0.0001
91720101|NCT01311661|183333241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.473|0.73|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.730|0.473|<0.0001
91720102|NCT01311661|183333241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.631|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.503|0.758|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.758|0.503|<0.0001
91720103|NCT01311661|183333241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.685|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.558|0.813|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.813|0.558|<0.0001
91720104|NCT01311661|183333242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.665|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.532|0.799|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.799|0.532|<0.0001
91487816|NCT02833350|182847906|SUPERIORITY||Adjusted Difference|-9.22|||<|0.0001|TWO_SIDED|95.0|-13.63|-4.81|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-4.81|-13.63|<0.0001
91487817|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
91527026|NCT01036022|182929428|SUPERIORITY_OR_OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.21|2.49||||||Placebo versus Asacol for Week 6 fecal calprotectin levels||2.49|0.21|
91527027|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.42|3.38||||||Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels||3.38|0.42|
91527028|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.35|||||TWO_SIDED|95.0|0.5|3.65||||||Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels||3.65|0.50|
91686327|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|2.11||||0.008|TWO_SIDED|95.0|1.22|3.66|||t-test, 2 sided|||Intraoperative hypotension associated with postoperative headache in total sample||3.66|1.22|0.008
91686328|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.024|TWO_SIDED|95.0|1.08|3.15|||t-test, 2 sided|||Female gender as a factor for developing postoperative headache||3.15|1.08|0.024
91686329|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.56||||0.005|TWO_SIDED|95.0|1.58|13.17|||t-test, 2 sided|||Association of female gender and postoperative headache||13.17|1.58|0.005
91686330|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.79||||0.006|TWO_SIDED|95.0|1.48|9.72|||t-test, 2 sided|||Association of intraoperative hypotension and postoperative headache||9.72|1.48|0.006
91686331|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.86||||0.041|TWO_SIDED|95.0|1.06|14.06|||t-test, 2 sided|||Association of caffeine consumption and postoperative headache||14.06|1.06|0.041
91686332|NCT02374346|183264001|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.26||||0.001|TWO_SIDED|95.0|1.82|9.95|||t-test, 2 sided|||Association of sevoflurane administration and postoperative headache||9.95|1.82|0.001
91686333|NCT00396565|183264003|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001||95.0|-17.16|-8.25|||ANCOVA|ANCOVA model with treatment as a factor and baseline score as a covariate||||-8.25|-17.16|<0.0001
91686334|NCT00396565|183264004|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001||95.0|-5.17|-2.51|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate.||||-2.51|-5.17|<0.0001
91686335|NCT00396565|183264005|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.71|-1.33|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate||||-1.33|-3.71|<0.0001
91487818|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
91487819|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
91487820|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
91487821|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
91720105|NCT01311661|183333242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.431|0.698|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.698|0.431|<0.0001
91720106|NCT01311661|183333242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.702|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.569|0.835|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.835|0.569|<0.0001
91720107|NCT01311661|183333242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.467|0.732|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.732|0.467|<0.0001
91720108|NCT01311661|183333243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.641|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.516|0.765|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.765|0.516|<0.0001
91720109|NCT01311661|183333243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.453|0.701|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.701|0.453|<0.0001
91720110|NCT01311661|183333243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.544|0.79|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.790|0.544|<0.0001
91720111|NCT01311661|183333243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.519|0.766|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.766|0.519|<0.0001
91720112|NCT01311661|183333244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.591|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.436|0.746|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.746|0.436|<0.0001
91720113|NCT01311661|183333244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.522|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.366|0.677|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.677|0.366|<0.0001
91487822|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
91720114|NCT01311661|183333244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.439|0.749|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.749|0.439|<0.0001
91720115|NCT01311661|183333244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.623|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.468|0.777|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.777|0.468|<0.0001
91720116|NCT01311661|183333245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.529|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.396|0.662|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.662|0.396|<0.0001
91720117|NCT01311661|183333245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.277|0.543|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.543|0.277|<0.0001
91720118|NCT01311661|183333245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.603|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.471|0.736|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.736|0.471|<0.0001
91527029|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.45|3.47||||||Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels||3.47|0.45|
91720119|NCT01311661|183333245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.349|0.613|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.613|0.349|<0.0001
91720120|NCT01311661|183333246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.957|STANDARD_ERROR_OF_MEAN|3.18|<|0.0001||95.0|26.709|39.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||39.206|26.709|<0.0001
91720121|NCT01311661|183333246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.632|STANDARD_ERROR_OF_MEAN|3.167|<|0.0001||95.0|26.409|38.855|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.855|26.409|<0.0001
91720122|NCT01311661|183333246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.66|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|25.448|37.872|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.872|25.448|<0.0001
91487823|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
91487824|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
91487825|NCT02833350|182847907|SUPERIORITY||Mean Difference (Net)|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
91487826|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
91487827|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
91527030|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.26|||||TWO_SIDED|95.0|0.44|3.59||||||Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels||3.59|0.44|
91686336|NCT00396565|183264006|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001||95.0|-8.58|-3.8|||ANCOVA|ANCOVA model with treatment as a factor, and with baseline score as a covariate||||-3.80|-8.58|<0.0001
91686337|NCT00396565|183264007|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Fisher Exact|||||||0.0007
91686338|NCT00396565|183264008|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.84|-0.34|||ANCOVA|ANCOVA model with treatment as a factor, and baseline score as a covariate||||-0.34|-0.84|<0.0001
91686339|NCT02211417|183264025|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.057
91686340|NCT01198132|183264035|SUPERIORITY_OR_OTHER||Rate ratio|0.8||||0.3797|TWO_SIDED|95.0|0.48|1.32|||Poisson log-linear model|||||1.32|0.48|0.3797
91686341|NCT01277211|183264045|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Pearl Indices|0.61||||0.531|TWO_SIDED|95.0|0.19|2.29|||Poisson distribution method|Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.||Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.||2.29|0.19|0.531
91686342|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-3.0||||0.346|TWO_SIDED|95.0|-9.9|3.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||3.1|-9.9|0.346
91686343|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-6.2||||0.029|TWO_SIDED|95.0|-12.7|-0.6|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-12.7|0.029
91686344|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-5.8||||0.019|TWO_SIDED|95.0|-11.8|-0.9|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.9|-11.8|0.019
91686345|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-8.0||||0.001|TWO_SIDED|95.0|-14.0|-2.9|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.9|-14.0|0.001
91686346|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.3||||0.556|TWO_SIDED|95.0|-6.4|2.6|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.6|-6.4|0.556
91686347|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.089|TWO_SIDED|95.0|-9.5|0.5|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-9.5|0.089
91686348|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-3.7||||0.11|TWO_SIDED|95.0|-9.4|0.8|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.8|-9.4|0.110
91686349|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-4.3||||0.049|TWO_SIDED|95.0|-9.8|0.0|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-9.8|0.049
91686350|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-1.1||||0.621|TWO_SIDED|95.0|-6.2|2.9|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.9|-6.2|0.621
91686351|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-4.4||||0.041|TWO_SIDED|95.0|-10.0|-0.2|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-10.0|0.041
91686352|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-3.8||||0.046|TWO_SIDED|95.0|-8.9|-0.1|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.9|0.046
91686353|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-4.4||||0.037|TWO_SIDED|95.0|-9.9|-0.2|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-9.9|0.037
91686354|NCT01277211|183264046|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.048|TWO_SIDED|95.0|-10.4|0.0|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-10.4|0.048
91527031|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.28|||||TWO_SIDED|95.0|0.5|3.28||||||Placebo versus Asacol for Week 1 fecal lactoferrin levels||3.28|0.50|
91527032|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.26|2.19||||||Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels||2.19|0.26|
91527033|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.59|||||TWO_SIDED|95.0|0.22|1.63||||||Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels||1.63|0.22|
91686355|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-6.0||||0.015|TWO_SIDED|95.0|-12.0|-1.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.1|-12.0|0.015
91527034|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.35|||||TWO_SIDED|95.0|0.12|1.0||||||Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels||1.00|0.12|
91527035|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.93|||||TWO_SIDED|95.0|0.31|2.77||||||Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels||2.77|0.31|
91686356|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-4.9||||0.012|TWO_SIDED|95.0|-10.1|-1.0|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-10.1|0.012
91686357|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-6.5||||0.002|TWO_SIDED|95.0|-12.0|-2.2|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.2|-12.0|0.002
91686358|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-3.6||||0.044|TWO_SIDED|95.0|-8.5|-0.1|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.5|0.044
91686359|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.0||||0.609|TWO_SIDED|95.0|-5.7|2.5|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.5|-5.7|0.609
91686360|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.062|TWO_SIDED|95.0|-9.3|0.2|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.2|-9.3|0.062
91686361|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-4.1||||0.019|TWO_SIDED|95.0|-9.0|-0.6|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-9.0|0.019
91686362|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-1.9||||0.308|TWO_SIDED|95.0|-6.7|1.6|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||1.6|-6.7|0.308
91686363|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-4.2||||0.027|TWO_SIDED|95.0|-9.3|-0.4|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.4|-9.3|0.027
91686364|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-2.9||||0.098|TWO_SIDED|95.0|-7.6|0.5|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-7.6|0.098
91686365|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-4.4||||0.009|TWO_SIDED|95.0|-9.4|-1.0|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-9.4|0.009
91686366|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-6.2||||0.002|TWO_SIDED|95.0|-11.7|-2.1|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.1|-11.7|0.002
91686367|NCT01277211|183264047|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.043|TWO_SIDED|95.0|-10.2|-0.1|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-10.2|0.043
91686368|NCT02924727|183264063|SUPERIORITY||Hazard Ratio (HR)|0.9012||||0.1659|TWO_SIDED|95.0|0.7778|1.0441|||Cox's Proportional Hazard Model|||Primary Composite||1.0441|0.7778|0.1659
91686369|NCT02924727|183264063|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.2031|TWO_SIDED|95.0|0.7104|1.0754|||Cox's Proportional Hazard Model|||CV Death||1.0754|0.7104|0.2031
91686370|NCT02924727|183264063|SUPERIORITY||Hazard Ratio (HR)|0.8653||||0.1679|TWO_SIDED|95.0|0.7044|1.0629|||Cox's Proportional Hazard Model|||First HF Hospitalization||1.0629|0.7044|0.1679
91686371|NCT02924727|183264063|SUPERIORITY||Hazard Ratio (HR)|0.6831||||0.0667|TWO_SIDED|95.0|0.4546|1.0266|||Cox's Proportional Hazard Model|||First Outpatient HF||1.0266|0.4546|0.0667
91686372|NCT02924727|183264064|SUPERIORITY||Hazard Ratio (HR)|0.9133||||0.2507|TWO_SIDED|95.0|0.7824|1.0662|||Cox's Proportional Hazard Model|||CV death or HF hospitalization||1.0662|0.7824|0.2507
91686373|NCT02924727|183264065|SUPERIORITY||Hazard Ratio (HR)|0.8422||||0.0732|TWO_SIDED|95.0|0.6979|1.0163|||Cox's Proportional Hazard Model|||HF hospitalization or Outpatient HF||1.0163|0.6979|0.0732
91686374|NCT02924727|183264066|SUPERIORITY||Hazard Ratio (HR)|0.9007||||0.1785|TWO_SIDED|95.0|0.7734|1.0489|||Cox's Proportional Hazard Model|||CV death, Non-fatal spontaneous MI or Non-fatal stroke||1.0489|0.7734|0.1785
91686375|NCT02924727|183264067|SUPERIORITY||Rate Ratio|0.8361||||0.0452|TWO_SIDED|95.0|0.7018|0.9961|||Negative Binomial regression model|||Total Number of Confirmed Composite Endpoints||0.9961|0.7018|0.0452
91686376|NCT02924727|183264068|SUPERIORITY||Hazard Ratio (HR)|0.8751||||0.1556|TWO_SIDED|95.0|0.7279|1.052|||Cox's Proportional Hazard Model|||All-Cause Death||1.0520|0.7279|0.1556
91686377|NCT04614246|183264070|OTHER||LS-Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.13|-1.14|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.14|-2.13|
91686378|NCT04614246|183264070|OTHER||LS-Mean|-2.13|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.66|-1.61|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.61|-2.66|
91686379|NCT04614246|183264070|OTHER||LS-Mean|-1.96|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.48|-1.43|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.43|-2.48|
91686380|NCT04614246|183264070|OTHER||LS-Mean|-1.94|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.44|-1.45|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.45|-2.44|
91720123|NCT01311661|183333246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.895|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|22.683|35.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.107|22.683|<0.0001
91686381|NCT04614246|183264071|OTHER|mixed model repeated measures|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.77|1.35||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.35|-0.77|
91686382|NCT04614246|183264071|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-1.27|0.91||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.91|-1.27|
91686383|NCT04614246|183264071|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|98.0|-1.17|1.02||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.02|-1.17|
91686384|NCT04614246|183264071|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|80.0|-0.4|0.98||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.98|-0.4|
91686385|NCT04614246|183264071|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|80.0|-0.89|0.53||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.53|-0.89|
91686386|NCT04614246|183264071|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|80.0|-0.79|0.64||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.64|-0.79|
91686387|NCT02521376|183264080|OTHER||Geometric Mean Ratio (GMR)|43.69|||||TWO_SIDED|90.0|24.59|77.62||||||||77.62|24.59|
91686388|NCT02521376|183264080|OTHER||GMR|233.63|||||TWO_SIDED|90.0|141.85|384.79||||||||384.79|141.85|
91686389|NCT02521376|183264080|OTHER||GMR|219.2|||||TWO_SIDED|90.0|139.74|343.84||||||||343.84|139.74|
91686390|NCT02521376|183264080|OTHER||GMR|108.5|||||TWO_SIDED|90.0|77.2|152.48||||||||152.48|77.20|
91686391|NCT02521376|183264081|OTHER||GMR|55.71|||||TWO_SIDED|90.0|34.7|89.42||||||||89.42|34.70|
91720124|NCT01311661|183333247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.87|STANDARD_ERROR_OF_MEAN|3.046|<|0.0001||95.0|22.884|34.856|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||34.856|22.884|<0.0001
91720125|NCT01311661|183333247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.056|STANDARD_ERROR_OF_MEAN|3.034|<|0.0001||95.0|26.094|38.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.018|26.094|<0.0001
91720126|NCT01311661|183333247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.816|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|25.864|37.767|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.767|25.864|<0.0001
91527036|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.87||||||Placebo versus Asacol for Week 2 fecal lactoferrin levels||1.87|0.26|
91686392|NCT02521376|183264081|OTHER||GMR|211.94|||||TWO_SIDED|90.0|132.49|339.03||||||||339.03|132.49|
91487828|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|3.64||||0.105|TWO_SIDED|95.0|-0.76|8.03|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.03|-0.76|0.1050
91487829|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
91487830|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|3.65||||0.127|TWO_SIDED|95.0|-1.04|8.35|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.35|-1.04|0.1270
91487831|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|5.45||||0.0501|TWO_SIDED|95.0|0.0|10.91|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.91|-0.00|0.0501
91487832|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
91686393|NCT02521376|183264081|OTHER||GMR|171.33|||||TWO_SIDED|90.0|108.17|271.37||||||||271.37|108.17|
91686394|NCT02521376|183264081|OTHER||GMR|107.35|||||TWO_SIDED|90.0|72.71|158.51||||||||158.51|72.71|
91686395|NCT00993421|183264199|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
91686396|NCT00993421|183264199|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
91686397|NCT00993421|183264199|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
91686398|NCT00993421|183264199|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
91487833|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
91487834|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
91686399|NCT00993421|183264199|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.041
91686400|NCT00993421|183264199|SUPERIORITY_OR_OTHER|||||||0.668||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.668
91686401|NCT00993421|183264199|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.437
91686402|NCT00993421|183264199|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.249
91686403|NCT04140032|183264264|SUPERIORITY||Difference between groups in change in B|-0.18|STANDARD_DEVIATION|0.06||0.003|TWO_SIDED|95.0|-0.31|-0.06|||Mixed Models Analysis|p \< 0.05 considered significant||||-0.06|-0.31|0.003
91686404|NCT04140032|183264265|SUPERIORITY||Odds ratio for difference between groups|1.29||||0.7|TWO_SIDED|95.0|0.034|4.91|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||4.91|.034|0.7
91686405|NCT04140032|183264266|SUPERIORITY||Difference between groups in change in f|-0.2|STANDARD_DEVIATION|0.19||0.3|TWO_SIDED|95.0|-0.58|0.17|||Mixed Models Analysis|||||0.17|-0.58|0.3
91686406|NCT04140032|183264270|SUPERIORITY||Odds ratio for difference between groups|1.1|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
91686407|NCT04140032|183264270|SUPERIORITY||Odds ratio for difference between groups|1.1||||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
91686408|NCT04205812|183264283|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0042|TWO_SIDED|95.0|0.6|0.93||The p-value was based on a stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis.|Log Rank||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.93|0.60|0.0042
91686409|NCT04205812|183264284|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Log Rank|The p-value was based on the stratified log-rank test for PFS.|A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.79|0.52|<0.0001
91487835|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
91487836|NCT02833350|182847907|SUPERIORITY||Adjusted Difference|0.68||||0.9051|TWO_SIDED|95.0|-10.58|11.95|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.95|-10.58|0.9051
91487837|NCT00075218|182847920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.329|||<|0.001||95.0|0.233|0.466||The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O'Brien-Fleming stopping rule.|Log Rank|two-sided unstratified log-rank test||The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.||0.466|0.233|<0.001
91487838|NCT00075218|182847921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.347|||<|0.001||95.0|0.253|0.475||No p-value adjustment for multiple comparisons.|Log Rank|||||0.475|0.253|<0.001
91686410|NCT04205812|183264285|SUPERIORITY|||||||0.0012||||||The p-value was calculated at the 1-sided 2.5% level from stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|||||||0.0012
91686411|NCT02514447|183264302|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Analysis was for Part 2 data: Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and sensitivity to first line treatment (sensitive or resistant) and treatment as fixed effects.||||<0.0001
91686412|NCT02514447|183264303|SUPERIORITY|||||||0.016||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using modified Poisson regression to account for the variable duration of the Treatment Period for each patient. The model included baseline ANC as a covariate, stratification factors of ECOG performance status (0 or 1 vs 2), sensitivity to 1st line treatment (sensitive or resistant), and treatment as fixed effects. The logarithm transformation of # of cycles was included as an offset variable in the modeling.||||0.0160
91686413|NCT05351164|183264325|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91686414|NCT05351164|183264326|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91686415|NCT03367572|183264339|SUPERIORITY||Mean Difference (Net)|0.7056||||0.008|TWO_SIDED||||||ANOVA|||||||0.008
91686416|NCT03367572|183264339|SUPERIORITY||Mean Difference (Net)|1.1486|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91686417|NCT03367572|183264340|SUPERIORITY||Mean Difference (Net)|0.4468||||0.01|TWO_SIDED||||||ANOVA|||||||0.010
91686418|NCT03367572|183264340|SUPERIORITY||Mean Difference (Net)|0.5632||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
91720127|NCT01311661|183333247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.327|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|27.375|39.278|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||39.278|27.375|<0.0001
91720128|NCT01311661|183333248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.581|STANDARD_ERROR_OF_MEAN|0.346|<|0.0001||95.0|-2.262|-0.9|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.900|-2.262|<0.0001
91720129|NCT01311661|183333248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.345|<|0.0001||95.0|-2.104|-0.748|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.748|-2.104|<0.0001
91720130|NCT01311661|183333248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.738|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001||95.0|-2.415|-1.062|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-1.062|-2.415|<0.0001
91720131|NCT01311661|183333248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.689|STANDARD_ERROR_OF_MEAN|0.344||0.0458||95.0|-1.366|-0.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.013|-1.366|0.0458
91720132|NCT01311661|183333249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.391|STANDARD_ERROR_OF_MEAN|19.484|<|0.0001||95.0|135.099|211.682|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||211.682|135.099|<0.0001
91720133|NCT01311661|183333249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|155.097|STANDARD_ERROR_OF_MEAN|19.406|<|0.0001||95.0|116.961|193.234|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||193.234|116.961|<0.0001
91487839|NCT00075218|182847923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.876||||0.306||95.0|0.679|1.129||No p-value adjustment for multiple comparisons.|Log Rank|||||1.129|0.679|0.306
91686419|NCT03367572|183264341|SUPERIORITY||Mean Difference (Net)|-0.59||||0.019|TWO_SIDED||||||t-test, 2 sided|||"Secondary Aim 1 is to determine if olanzapine is more effective than prochlorperazine in controlling nausea at Cycle 2 in participants who experienced CINV at Cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.~This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean, and testing whether D = 0 versus the one-sided alternative hypothesis that D \> 0."||||0.019
91686420|NCT03367572|183264342|SUPERIORITY||Odds Ratio (OR)|1.31||||0.386|TWO_SIDED|97.5|0.65|2.66||prochlorperazine arm statistics|Regression, Logistic|||||2.66|0.65|0.386
91720134|NCT01311661|183333249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.268|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|111.204|187.333|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||187.333|111.204|<0.0001
91720135|NCT01311661|183333249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.441|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|112.377|188.505|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||188.505|112.377|<0.0001
91720136|NCT01311661|183333250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.251|STANDARD_ERROR_OF_MEAN|18.997|<|0.0001||95.0|104.916|179.586|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||179.586|104.916|<0.0001
91720137|NCT01311661|183333250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.138|STANDARD_ERROR_OF_MEAN|18.92|<|0.0001||95.0|94.954|169.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||169.322|94.954|<0.0001
91720138|NCT01311661|183333250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.136|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|105.021|179.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||179.251|105.021|<0.0001
91487840|NCT00075218|182847924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.505||||0.306||95.0|0.262|1.134||No p-value adjustment for multiple comparisons.|Rank Preserving Structural Failure Time||95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.|||1.134|0.262|0.306
91686421|NCT03367572|183264342|SUPERIORITY||Odds Ratio (OR)|0.16||||0.036|TWO_SIDED|97.5|0.02|1.13||olanzapine arm statistics|Regression, Logistic|||||1.13|0.02|0.036
91686422|NCT05026177|183264361|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.5335|TWO_SIDED|95.0|-0.96|1.86|||Mixed Models Analysis|||||1.86|-0.96|0.5335
91686423|NCT05026177|183264361|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.5836|TWO_SIDED|95.0|-0.99|1.76|||Mixed Models Analysis|||||1.76|-0.99|0.5836
91686424|NCT05026177|183264362|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0763|TWO_SIDED|95.0|-3.3|0.17|||Mixed Models Analysis|||||0.17|-3.30|0.0763
91686425|NCT05026177|183264362|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.153|TWO_SIDED|95.0|-2.93|0.46|||Mixed Models Analysis|||||0.46|-2.93|0.1530
91686426|NCT00733005|183264504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0|||||ANCOVA|||||||0.102
91686427|NCT00733005|183264505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0|||||ANCOVA|||||||0.019
91720139|NCT01311661|183333250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.306|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|120.192|194.42|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||194.420|120.192|<0.0001
91720140|NCT01311661|183333251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.554|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001||95.0|-0.78|-0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.329|-0.780|<0.0001
91487841|NCT00075218|182847926|SUPERIORITY_OR_OTHER||rate (percentage)|6.6||||||95.0|3.8|10.5|||||Used exact method based on binomial distribution.|||10.5|3.8|
91686428|NCT01769456|183264507|OTHER||||||<|0.0001||||||Reported p-value is the calculated value provided by SAS output.|Wilcoxon Signed Rank Test|||||||< 0.0001
91686429|NCT01769456|183264508|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
91686430|NCT01769456|183264509|OTHER|||||||0.0003|||||||Wilcoxon Signed Rank Test|||||||0.0003
91686431|NCT01769456|183264510|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
91686432|NCT03860974|183264542|NON_INFERIORITY|"We tested the non-inferiority of serratus block compared with PVB using the 95% CI associated with the Wilcoxon-Mann-Whitney test with continuity correction. If the lower limit of the 95% CI for median average PACU pain scores was greater than -1.25 , we would conclude non-inferiority. The non-inferiority of serratus blocks with regard to opioid consumption was similarly tested to a predefined non-inferiority margin of 2 mg intravenous morphine equivalents."|Median Difference (Final Values)|4.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
91686433|NCT00886015|183264567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.96|1.93||||||||1.93|0.96|
91686434|NCT00886015|183264568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.46|0.98||||||||0.98|0.46|
91686435|NCT00886015|183264569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18||||||||1.18|0.66|
91686436|NCT00886015|183264570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.44|0.98||||||||0.98|0.44|
91720141|NCT01311661|183333251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.862|-0.412|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.412|-0.862|<0.0001
91686437|NCT00886015|183264571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||Mild ECA compared with Normal||0.97|0.42|
91686438|NCT00886015|183264571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.39|1.01||||||Moderate ECA compared with Normal||1.01|0.39|
91686439|NCT00886015|183264571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Severe ECA compared with Normal||1.10|0.35|
91686440|NCT00886015|183264572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.97|1.53||||||||1.53|0.97|
91686441|NCT05992623|183264574|SUPERIORITY|||||||0.565|||||||Chi-squared|||||||0.565
91686442|NCT05992623|183264575|SUPERIORITY|||||||0.617|||||||Chi-squared|||||||0.617
91686443|NCT05992623|183264576|SUPERIORITY||Mean Difference (Final Values)|0.04|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91686444|NCT01983566|183264581|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|115.8||||0.3944|TWO_SIDED|90.0|63.52|211.11||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% confidence interval (CI) based on the t-distribution was computed.~These were then back transformed. The estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||211.11|63.52|0.3944
91686445|NCT01983566|183264582|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|114.83||||0.3674|TWO_SIDED|90.0|74.803|176.281||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% CI based on the t-distribution was computed.~These were then back transformed. This estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||176.281|74.803|0.3674
91686446|NCT02794870|183264596|OTHER||% vaccine recipients with solicited AEs|60.0|||||TWO_SIDED|90.0|39.0|78.0||||||||78|39|
91686447|NCT02794870|183264596|OTHER||% placebo recipients with solicited AEs|27.0|||||TWO_SIDED|90.0|8.0|56.0||||||||56|8|
91487842|NCT00075218|182847926|SUPERIORITY_OR_OTHER||Treatment Difference (%)|6.58||||0.004||95.0|3.47|9.7||No p-value adjustment for multiple comparisons.|Pearson chi-square test|||||9.70|3.47|0.004
91487843|NCT00075218|182847929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.339|||<|0.001||95.0|0.244|0.472||two-sided unstratified log-rank test|Log Rank|||||0.472|0.244|<0.001
91487844|NCT00075218|182847929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.327|||<|0.001||95.0|0.232|0.46|||Log Rank|log-rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score||Stratified log-rank test||0.460|0.232|<0.001
91686448|NCT02794870|183264597|OTHER||% vaccinees with unsolicited AEs|35.0|||||TWO_SIDED|90.0|18.0|56.0||||||||56|18|
91686449|NCT02794870|183264597|OTHER||% placebo with unsolicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0||||||||47|3|
91686450|NCT02794870|183264602|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
91686451|NCT02794870|183264603|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
91686452|NCT03277066|183264707|SUPERIORITY||Lest-Squared Mean Differences|0.011||||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0110
91686453|NCT03277066|183264707|SUPERIORITY||Lest-Squared Mean Differences|0.2835||||0.2835|TWO_SIDED||||||Mixed Models Analysis|||||||0.2835
91686454|NCT01153425|183264712|OTHER|unpaired t-test for the difference of the means between the two arms|||||>|0.05|||||||t-test, 2 sided|||paired t-test for change from baseline to 24 months||||>0.05
91686455|NCT00911300|183264723|SUPERIORITY_OR_OTHER||Percentage of participants|0.5||||1|TWO_SIDED|95.0|-2.0|3.1|||Fisher Exact||The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.|||3.1|-2.0|1.000
91686456|NCT01565356|183264735|SUPERIORITY_OR_OTHER||Kappa statistic|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||Cohen's (simple) kappa statistic||1.00|1.00|
91686457|NCT02288325|183264747|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0212|TWO_SIDED|95.0|0.33|0.92|||Log Rank|||||0.92|0.33|0.0212
91686458|NCT00490841|183264856|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||1-sided exact binomial test|||"objective is to demonstrate the binary restenosis rate at 9 months is \< 28.6% OPC. Assumptions for the primary endpoint analysis:~* H0: Restenosis Rate ≥ 28.6%~* HA: Restenosis Rate \< 28.6%~* Assumed binary restenosis rate = 20%~* Power = 80%~* One-sided type I error = 5%~With the above assumptions, 161 samples would be required. To account for approximately 20% lost to follow-up rate, 202 subjects will be enrolled in the study. The sample size calculation was performed using PASS 2005."||||< 0.0001
91686459|NCT03452943|183264873|OTHER||LS mean difference|-0.7||||0.692|TWO_SIDED|95.0|-4.1|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.8|-4.1|0.692
91686460|NCT04803305|183264966|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.38|1.18|||||Week 4|||1.18|-2.38|
91686461|NCT04803305|183264967|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|-0.75|3.15|||||Week 1|||3.15|-0.75|
91686462|NCT04803305|183264967|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-0.28|2.49|||||Week 2|||2.49|-0.28|
91686463|NCT04803305|183264967|SUPERIORITY||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-0.93|2.99|||||Week 3|||2.99|-0.93|
91720142|NCT01311661|183333251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.813|-0.364|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.364|-0.813|<0.0001
91686464|NCT04803305|183264967|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-2.02|2.02|||||Week 5|||2.02|-2.02|
91686465|NCT04803305|183264967|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.11|1.51|||||Week 6|||1.51|-3.11|
91686466|NCT04803305|183264968|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.98|||TWO_SIDED|90.0|-4.18|3.53|||||Week 1|||3.53|-4.18|
91686467|NCT04803305|183264968|SUPERIORITY||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-5.49|1.16|||||Week 2|||1.16|-5.49|
91720143|NCT01311661|183333251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.77|-0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.322|-0.770|<0.0001
91720144|NCT01311661|183333256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.461|-0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.253|-0.461|<0.0001
91686468|NCT04803305|183264968|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.62|2.06|||||Week 3|||2.06|-0.62|
91686469|NCT04803305|183264968|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.29|2.2|||||Week 4|||2.20|-1.29|
91686470|NCT04803305|183264968|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.21|2.57|||||Week 5|||2.57|-1.21|
91686471|NCT04803305|183264968|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.34|3.39|||||Week 6|||3.39|0.34|
91686472|NCT00754546|183264971|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||"ANOVA was used to examine the interaction between mode of exercise and treatment effect.~Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05."||||< 0.05
91686473|NCT00754546|183264971|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||Comparing arformoterol with placebo with treadmill exercise||||0.024
91686474|NCT00754546|183264971|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||Arformoterol versus normal saline with cycle exercise||||0.038
91686475|NCT01965860|183264982|SUPERIORITY|||||||0.001|||||||ANOVA|||"Prior to the study a power analysis was performed to calculate the number of participants required in each of the three groups. Previous work comparing OSATS derived scores in endovascular interventions shows a Cohen D of two. Using a of .05, a power of .80, and an expected dropout rate of 10%, the minimum number of surgical trainees required per group was seven.~Null hypothesis for primary outcome: no difference in technical performance during real life procedures between the three groups"||||0.001
91686476|NCT01965860|183264982|OTHER|||||||0.003|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.003
91686477|NCT01965860|183264982|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.001
91686478|NCT01965860|183264982|OTHER|||||||0.228|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.228
91686479|NCT01965860|183264982|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.001
91686480|NCT01965860|183264982|OTHER|||||||0.008|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.008
91686481|NCT01965860|183264982|OTHER|||||||0.164|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.164
91686482|NCT01965860|183264982|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
91686483|NCT01965860|183264982|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
91686484|NCT01965860|183264982|OTHER|||||||0.19|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.190
91686485|NCT03901092|183265001|OTHER||Fleiss' kappa|0.87|||||TWO_SIDED|95.0|0.83|0.91||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.91|0.83|
91720145|NCT01311661|183333256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.4|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.400|<0.0001
91686486|NCT03901092|183265004|OTHER||Fleiss' kappa|0.84|||||TWO_SIDED|95.0|0.8|0.88||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.88|0.80|
91686487|NCT03901092|183265005|OTHER||Fleiss' kappa|0.9|||||TWO_SIDED|95.0|0.85|0.95||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.95|0.85|
91686488|NCT03901092|183265006|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.69|1.0||||||Cohen's kappa statistic for Reader 1||1.00|0.69|
91686489|NCT03901092|183265006|OTHER||Cohen's kappa|0.71|||||TWO_SIDED|95.0|0.41|1.0||||||Cohen's kappa statistic for Reader 2||1.00|0.41|
91686490|NCT03901092|183265006|OTHER||Cohen's kappa|0.6|||||TWO_SIDED|95.0|0.24|0.95||||||Cohen's kappa statistic for Reader 3||0.95|0.24|
91686491|NCT03901092|183265006|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.67|1.0||||||Cohen's kappa statistic for Reader 4||1.00|0.67|
91686492|NCT03901092|183265006|OTHER||Cohen's kappa|0.79|||||TWO_SIDED|95.0|0.52|1.0||||||Cohen's kappa statistic for Reader 5||1.00|0.52|
91686493|NCT04138823|183265015|OTHER||Probability of DLT rate in [0.16,0.33)|0.172|||||||||||Bayesian logistic regression model|||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91720146|NCT01311661|183333256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.198|-0.405|<0.0001
91686494|NCT04138823|183265015|OTHER||Probability of DLT rate in [0.33, 1.00]|0.01||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91686495|NCT04138823|183265015|OTHER||Probabilty of DLT rate in [0.16, 0.33)|0.362||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91720147|NCT01311661|183333256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.302|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.198|-0.405|<0.0001
91720148|NCT01900314|183333258|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate||||0.16
91720149|NCT01900314|183333259|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Repeated measures ANCOVA with baseline MADRS as co-variate||||0.04
91686496|NCT04138823|183265015|OTHER||Probability of DLT rate in [0.33, 1.00]|0.046||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
91686497|NCT04138823|183265015|OTHER||Probability of DLT rate in [0.16, 0.33)|0.478||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
91686498|NCT04138823|183265015|OTHER||Probability of DLT rate in [0.33, 1.00]|0.118||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
91686499|NCT02466685|183265058|SUPERIORITY||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|9.4|<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
91686500|NCT03097991|183265104|SUPERIORITY||Slope|1.86|STANDARD_ERROR_OF_MEAN|1.86||0.32|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.32
91686501|NCT03097991|183265104|SUPERIORITY||Slope|-0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.53
91686502|NCT03097991|183265105|SUPERIORITY||Slope|-3.04|STANDARD_ERROR_OF_MEAN|1.63||0.07|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.07
91686503|NCT03097991|183265105|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||||Group Effect|||.69
91686504|NCT03097991|183265106|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|2.0||0.22|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.22
91686505|NCT03097991|183265106|SUPERIORITY||Slope|0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group effect|||||.53
91686506|NCT03097991|183265107|SUPERIORITY||Slope|-1.73|STANDARD_ERROR_OF_MEAN|1.76||0.33|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.33
91686507|NCT03097991|183265107|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.69
91686508|NCT03097991|183265108|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
91686509|NCT03097991|183265108|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
91686510|NCT03097991|183265109|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
91686511|NCT03097991|183265109|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.85
91686512|NCT03097991|183265110|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
91720150|NCT04513366|183333319|SUPERIORITY||Risk Difference (RD)|0.44|||<|0.0001|TWO_SIDED|97.5|0.23|0.64|||Mantel Haenszel|||||0.64|0.23|<.0001
91720151|NCT04513366|183333319|SUPERIORITY||Risk Difference (RD)|0.53|||<|0.0001|TWO_SIDED|97.5|0.32|0.73|||Mantel Haenszel|||||0.73|0.32|<.0001
91487845|NCT00075218|182847930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.972||||0.9322||95.0|0.508|1.86|||Log Rank|2-sided, unstratified log-rank test||||1.860|0.508|0.9322
91487846|NCT00075218|182847931|SUPERIORITY_OR_OTHER||Treatment Difference (percent)|17.3||||0.0046||95.0|6.7|28.0|||Pearson chi-square||95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)\*100.|||28.0|6.7|0.0046
91720152|NCT04513366|183333320|SUPERIORITY||Least Square (LS) Mean Difference|-5.3|||<|0.001|TWO_SIDED|97.5|-7.18|-3.42|||ANCOVA|||||-3.42|-7.18|<.001
91487847|NCT00131508|182847934|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.||||0.17
91487848|NCT00131508|182847935|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.||||0.53
91686513|NCT03097991|183265110|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
91720153|NCT04513366|183333320|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.57|-3.7|||ANCOVA|||||-3.70|-7.57|<.001
91487849|NCT00131508|182847936|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.||||0.24
91686514|NCT03097991|183265111|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint effect|||||.85
91686515|NCT03097991|183265111|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
91686516|NCT03097991|183265112|SUPERIORITY||Slope|21.01|STANDARD_ERROR_OF_MEAN|5.91|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.001
91686517|NCT03097991|183265112|SUPERIORITY||Slope|2.98|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
91720154|NCT04513366|183333321|SUPERIORITY||LS Mean Difference|-64.3|||<|0.001|TWO_SIDED|97.5|-87.85|-40.85|||ANCOVA|||||-40.85|-87.85|<.001
91720155|NCT04513366|183333321|SUPERIORITY||LS Mean Difference|-69.8|||<|0.001|TWO_SIDED|97.5|-92.16|-47.35|||ANCOVA|||||-47.35|-92.16|<.001
91487850|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.||||0.62
91487851|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.||||0.14
91487852|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.||||0.20
91487853|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.||||0.62
91487854|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.||||0.61
91487855|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.||||0.65
91487856|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.||||0.55
91487857|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.||||0.69
91686518|NCT03097991|183265113|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|linear mixed effects|Group|||||<.05
91686519|NCT03097991|183265113|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.05
91686520|NCT03097991|183265114|SUPERIORITY||Slope|3.52|STANDARD_ERROR_OF_MEAN|4.14||0.39|TWO_SIDED||||||Mixed Models Analysis||Group|"We analyzed the CTS scales Psychological Aggression and Physical Assault. Inspection of the latter in the raw data and descriptives showed extremely consistent selection of the lowest value of the scale (no incidents of assault) across all respondents, so we did not conduct inferential tests."||||.39
91686521|NCT03097991|183265114|SUPERIORITY||Slope|-13.38|STANDARD_ERROR_OF_MEAN|4.86|<|0.005|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||<.005
91686522|NCT03097991|183265115|SUPERIORITY||Slope|-1.17|STANDARD_ERROR_OF_MEAN|1.25||0.24|TWO_SIDED||||||Mixed Models Analysis||Group|||||.24
91686523|NCT03097991|183265115|EQUIVALENCE|ANOVA found a main effect of group, F(1, 155) = 6.85, p \< .05, η2G = .04.|Mean Difference (Final Values)|6.85|||<|0.05|TWO_SIDED||||||ANOVA||Group|||||<.05
91686524|NCT03097991|183265116|SUPERIORITY||Slope|-2.53|STANDARD_ERROR_OF_MEAN|1.04||0.02|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.02
91686525|NCT03097991|183265116|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED||||||Mixed Models Analysis||Group|||||.56
91686526|NCT03097991|183265117|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.30
91720156|NCT04513366|183333322|SUPERIORITY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.6||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
91720157|NCT04513366|183333322|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED||||||Mixed Models Analysis|||||||0.472
91720158|NCT04513366|183333323|SUPERIORITY||Difference|0.58||||0.0003|TWO_SIDED|97.5|0.25|0.91|||Chi-squared|||||0.91|0.25|0.0003
91720159|NCT04513366|183333323|SUPERIORITY||Difference|0.25||||0.1895|TWO_SIDED|97.5|-0.36|0.86|||Chi-squared|||||0.86|-0.36|0.1895
91720160|NCT04513366|183333324|SUPERIORITY||Difference|0.43||||0.0035|TWO_SIDED|97.5|0.14|0.72|||Chi-squared|||||0.72|0.14|0.0035
91487858|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.||||0.82
91686527|NCT03097991|183265117|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.67||0.36|TWO_SIDED||||||Mixed Models Analysis||Group|||||.36
91686528|NCT03097991|183265118|SUPERIORITY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.55||0.17|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.17
91686529|NCT03097991|183265118|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
91686530|NCT03097991|183265119|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|7.34||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
91686531|NCT03097991|183265119|SUPERIORITY||Slope|7.94|STANDARD_ERROR_OF_MEAN|9.0||0.38|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||.38
91686532|NCT03097991|183265120|SUPERIORITY||Slope|-1.89|STANDARD_ERROR_OF_MEAN|1.05||0.07|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.07
91686533|NCT03097991|183265120|SUPERIORITY||Slope|2.52|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
91686534|NCT03097991|183265121|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.92|TWO_SIDED||||||Mixed Models Analysis||Group|||||.92
91686535|NCT03097991|183265121|SUPERIORITY||Slope|1.12|STANDARD_ERROR_OF_MEAN|0.57||0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.05
91686536|NCT03097991|183265122|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.81|TWO_SIDED||||||Mixed Models Analysis||Group|||||.81
91686537|NCT03097991|183265122|SUPERIORITY||Slope|-0.67|STANDARD_ERROR_OF_MEAN|0.7||0.34|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.34
91686538|NCT03097991|183265123|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.76|TWO_SIDED||||||Mixed Models Analysis||Group|||||.76
91686539|NCT03097991|183265123|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.49||0.53|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.53
91720161|NCT04513366|183333324|SUPERIORITY||Difference|0.28||||0.0428|TWO_SIDED|97.5|-0.02|0.57|||Chi-squared|||||0.57|-0.02|0.0428
91686540|NCT03097991|183265124|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
91686541|NCT03097991|183265124|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.95
91686542|NCT03097991|183265125|SUPERIORITY||Slope|0.82|STANDARD_ERROR_OF_MEAN|1.13||0.47|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.47
91686543|NCT03097991|183265125|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
91686544|NCT03097991|183265126|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.32||0.68|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.68
91487859|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.||||0.99
91487860|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.||||0.30
91527037|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.53|||||TWO_SIDED|95.0|0.15|1.84||||||Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels||1.84|0.15|
91527038|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.32|2.87||||||Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels||2.87|0.32|
91686545|NCT03097991|183265126|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
91686546|NCT03097991|183265127|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|1.9||0.65|TWO_SIDED||||||Mixed Models Analysis||Group|||||.65
91686547|NCT03097991|183265127|SUPERIORITY||Slope|-1.65|STANDARD_ERROR_OF_MEAN|2.44||0.5|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.50
91686548|NCT03097991|183265128|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|1.3||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
91686549|NCT03097991|183265128|SUPERIORITY||Slope|-1.92|STANDARD_ERROR_OF_MEAN|1.72||0.27|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.27
91686550|NCT03097991|183265129|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|1.22||0.01|TWO_SIDED||||||Mixed Models Analysis||Group|||||.01
91686551|NCT03097991|183265129|SUPERIORITY||Slope|1.08|STANDARD_ERROR_OF_MEAN|1.96||0.58|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.58
91686552|NCT01330303|183265145|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.89||||||90.0|94.91|109.39|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.39|94.91|
91686553|NCT01330303|183265146|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.91||||||90.0|95.0|109.33|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.33|95.00|
91686554|NCT01330303|183265147|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.04||||||90.0|86.33|102.44|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||102.44|86.33|
91686555|NCT03516513|183265157|SUPERIORITY|t-tests||||||0.905|||||||t-test, 2 sided|||||||0.905
91686556|NCT03516513|183265157|SUPERIORITY|t-test||||||0.32|||||||t-test, 2 sided|||||||.320
91720162|NCT04513366|183333325|SUPERIORITY||LS Mean Difference|-0.2||||0.517|TWO_SIDED|97.5|-1.1|0.61|||Mixed Models Analysis|||||0.61|-1.10|0.517
91487861|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.||||0.24
91487862|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.||||0.50
91686557|NCT03516513|183265158|SUPERIORITY|||||||0.155||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.155
91686558|NCT03516513|183265158|SUPERIORITY|||||||0.974||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.974
91487863|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.||||0.45
91527039|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.52|||||TWO_SIDED|95.0|0.17|1.56||||||Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels||1.56|0.17|
91686559|NCT03516513|183265160|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||||||.212
91686560|NCT03516513|183265161|SUPERIORITY|||||||0.507|||||||t-test, 2 sided|||||||.507
91686561|NCT03516513|183265162|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||.091
91686562|NCT02593110|183265163|SUPERIORITY||Mean Difference (Final Values)|-24.41||||0.1107|TWO_SIDED|95.0|-54.59|5.78|||ANCOVA|||||5.78|-54.59|0.1107
91686563|NCT02593110|183265163|SUPERIORITY||Mean Difference (Final Values)|9.78||||0.5378|TWO_SIDED|95.0|-21.84|41.39|||ANCOVA|||||41.39|-21.84|0.5378
91686564|NCT02593110|183265163|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.956|TWO_SIDED|95.0|-24.96|26.38|||ANCOVA|||||26.38|-24.96|0.9560
91686565|NCT02593110|183265164|SUPERIORITY||Mean Difference (Final Values)|31.35||||0.6121|TWO_SIDED|95.0|-92.42|155.12|||ANCOVA|||||155.12|-92.42|0.6121
91686566|NCT02593110|183265164|SUPERIORITY||Mean Difference (Final Values)|141.78||||0.0116|TWO_SIDED|95.0|33.14|250.42|||ANCOVA|||||250.42|33.14|0.0116
91686567|NCT02593110|183265164|SUPERIORITY||Mean Difference (Final Values)|-14.75||||0.8146|TWO_SIDED|95.0|-140.89|111.39|||ANCOVA|||||111.39|-140.89|0.8146
91686568|NCT02593110|183265165|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.8755|TWO_SIDED|95.0|-10.84|12.68|||ANCOVA|||||12.68|-10.84|0.8755
91720163|NCT04513366|183333325|SUPERIORITY||LS Mean Difference|0.4||||0.23|TWO_SIDED|97.5|-0.39|1.28|||Mixed Models Analysis|||||1.28|-0.39|0.230
91487864|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.||||0.46
91487865|NCT00131508|182847937|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.||||0.84
91487866|NCT00131508|182847938|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.20
91487867|NCT00131508|182847938|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.81
91487868|NCT00131508|182847938|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.||||0.70
91686569|NCT02593110|183265165|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.7651|TWO_SIDED|95.0|-13.83|18.7|||ANCOVA|||||18.70|-13.83|0.7651
91686570|NCT02593110|183265165|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.3776|TWO_SIDED|95.0|-8.65|22.41|||ANCOVA|||||22.41|-8.65|0.3776
91686571|NCT02593110|183265166|SUPERIORITY||Mean Difference (Final Values)|-8.06||||0.1782|TWO_SIDED|95.0|-19.91|3.79|||ANCOVA|||||3.79|-19.91|0.1782
91686572|NCT02593110|183265166|SUPERIORITY||Mean Difference (Final Values)|-5.27||||0.3555|TWO_SIDED|95.0|-16.61|6.07|||ANCOVA|||||6.07|-16.61|0.3555
91686573|NCT02593110|183265166|SUPERIORITY||Mean Difference (Final Values)|5.75||||0.3294|TWO_SIDED|95.0|-5.99|17.49|||ANCOVA|||||17.49|-5.99|0.3294
91686574|NCT02593110|183265167|SUPERIORITY||Mean Difference (Final Values)|-8.72||||0.1569|TWO_SIDED|95.0|-20.91|3.47|||ANCOVA|||||3.47|-20.91|0.1569
91686575|NCT02593110|183265167|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.7692|TWO_SIDED|95.0|-16.16|12.02|||ANCOVA|||||12.02|-16.16|0.7692
91686576|NCT02593110|183265167|SUPERIORITY||Mean Difference (Final Values)|3.09||||0.6306|TWO_SIDED|95.0|-9.74|15.91|||ANCOVA|||||15.91|-9.74|0.6306
91686577|NCT02593110|183265168|SUPERIORITY||Mean Difference (Final Values)|-7.86||||0.3542|TWO_SIDED|95.0|-24.74|9.02|||ANCOVA|||||9.02|-24.74|0.3542
91686578|NCT02593110|183265168|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.9417|TWO_SIDED|95.0|-17.98|16.71|||ANCOVA|||||16.71|-17.98|0.9417
91686579|NCT02593110|183265168|SUPERIORITY||Mean Difference (Final Values)|5.45||||0.4508|TWO_SIDED|95.0|-8.96|19.86|||ANCOVA|||||19.86|-8.96|0.4508
91686580|NCT01130597|183265169|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.5|||||TWO_SIDED|95.0|80.4|96.4|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||96.4|80.4|
91686581|NCT01130597|183265174|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|84.1|||||TWO_SIDED|95.0|72.7|92.1|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||92.1|72.7|
91686582|NCT00207883|183265227|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91686583|NCT00307437|183265229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||<0.001
91720164|NCT04513366|183333326|SUPERIORITY||LS Mean Difference|-0.1||||0.25|TWO_SIDED|97.5|-0.35|0.12|||Mixed Models Analysis|||||0.12|-0.35|0.250
91720165|NCT04513366|183333326|SUPERIORITY||LS Mean Difference|0.1||||0.506|TWO_SIDED|97.5|-0.16|0.29|||Mixed Models Analysis|||||0.29|-0.16|0.506
91720166|NCT04513366|183333327|SUPERIORITY||LS Mean Difference|-0.1||||0.653|TWO_SIDED|97.5|-0.55|0.37|||ANOVA|||||0.37|-0.55|0.653
91720167|NCT04513366|183333327|SUPERIORITY||LS Mean Difference|0.1||||0.629|TWO_SIDED|97.5|-0.36|0.56|||ANOVA|||||0.56|-0.36|0.629
91720168|NCT04513366|183333328|SUPERIORITY||LS Mean Difference|0.1||||0.731|TWO_SIDED|97.5|-0.4|0.54|||ANOVA|||Treatment Periods 1-3 (Months 1-3)||0.54|-0.40|0.731
91487869|NCT00131508|182847939|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.69
91487870|NCT00131508|182847939|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.75
91487871|NCT00131508|182847939|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.93
91487872|NCT00131508|182847940|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.56
91686584|NCT00307437|183265229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 1200 participants (400 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
91720169|NCT04513366|183333328|SUPERIORITY||LS Mean Difference|0.1||||0.583|TWO_SIDED|97.5|-0.35|0.58|||ANOVA|||Treatment Periods 1-3 (Month 1-3)||0.58|-0.35|0.583
91487873|NCT00131508|182847940|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||1.0
91487874|NCT00131508|182847940|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.61
91487875|NCT00131508|182847941|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.||||0.83
91686585|NCT00307437|183265230|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||||||<0.001
91686586|NCT00307437|183265230|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint need to be significant first.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significancd level of 0.05.||||<0.001
91686587|NCT00307437|183265231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
91487876|NCT00131508|182847942|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.||||0.40
91686588|NCT00307437|183265231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first.|ANOVA on van der Waerden normal scores|Analysis of varianceon van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤90 kg vs \>90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
91686589|NCT00307437|183265232|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.468
91686590|NCT00307437|183265232|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.210
91686591|NCT00307437|183265232|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested.|Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between combined q8 group and the combined q12 group, 45 mg q8 and 45 mg q12, 90 mg q8 and 90 mg q12 at an overall significance level of 0.05.||||0.014
91720170|NCT00269152|183333340|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|59.4|||||TWO_SIDED|95.0|46.4|71.5||||||||71.5|46.4|
91720171|NCT00269152|183333340|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|50.0||||||95.0|36.1|63.9||||||||63.9|36.1|
91487877|NCT01904058|182847985|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.28||||0.6603|TWO_SIDED|95.0|-12.59|8.03||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.||8.03|-12.59|0.6603
91527040|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.42|||||TWO_SIDED|95.0|0.45|4.46||||||Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels||4.46|0.45|
91527041|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.14|1.01||||||Placebo versus Asacol for Week 3 fecal lactoferrin levels||1.01|0.14|
91720172|NCT03043053|183333345|OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
91686592|NCT06360081|183265262|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|99.89|||<|0.0001|TWO_SIDED|90.0|97.08|102.78||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 9.0%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||102.78|97.08|<0.0001
91686593|NCT06360081|183265263|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|100.83|||<|0.0001|TWO_SIDED|90.0|96.43|105.44||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 14.2%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||105.44|96.43|<0.0001
91686594|NCT00352417|183265265|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|Satterthwaite's method||||||0.97
91686595|NCT00352417|183265266|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|Satterthwaite's method||||||0.37
91686596|NCT00352417|183265267|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91686597|NCT00352417|183265268|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|ANCOVA was performed on the natural log transformed data||||||<0.01
91686598|NCT00352417|183265269|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91686599|NCT03573830|183265317|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.002|TWO_SIDED|95.0|0.04|0.2||Threshold for significance: \<0.05|t-test, 2 sided|||||0.20|0.04|0.002
91686600|NCT03573830|183265318|SUPERIORITY||Mean Difference (Final Values)|0.15||||0|TWO_SIDED|95.0|0.07|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.07|0.000
91686601|NCT03573830|183265319|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.352|TWO_SIDED|95.0|-0.03|0.07||Threshold for significance: 0.05|t-test, 2 sided|||||0.07|-0.03|0.352
91686602|NCT03573830|183265320|SUPERIORITY||Mean Difference (Final Values)|0.45||||0|TWO_SIDED|95.0|0.34|0.56||Threshold for significance: \<0.05|t-test, 2 sided|||||0.56|0.34|0.000
91686603|NCT03573830|183265321|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.002|TWO_SIDED|95.0|0.05|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.05|0.002
91686604|NCT03573830|183265322|SUPERIORITY||Mean Difference (Final Values)|32.56||||0.033|TWO_SIDED|95.0|2.65|62.46||Threshold for significance: \<0.05|t-test, 2 sided|||||62.46|2.65|0.033
91686605|NCT03573830|183265324|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.065|TWO_SIDED|95.0|0.0|0.19||Threshold for significance: \<0.05|t-test, 2 sided|||||0.19|0.00|0.065
91686606|NCT03573830|183265325|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.03|TWO_SIDED|95.0|0.01|0.28||Threshold for significance: \<0.05|t-test, 2 sided|||||0.28|0.01|0.030
91686607|NCT00266630|183265326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||||TWO_SIDED|95.0|-4.1|-1.9||||||||-1.90|-4.10|
91686608|NCT00266630|183265330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||||TWO_SIDED|95.0|-25.58|-14.06||||||||-14.06|-25.58|
91686609|NCT00879255|183265386|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.75|||>|0.05|TWO_SIDED|95.0|-11.92|2.42||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority analysis|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.42|-11.92|> .05
91686610|NCT00879255|183265387|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.76|||>|0.05|TWO_SIDED|95.0|-11.65|2.13||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority design|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.13|-11.65|> .05
91720173|NCT03043053|183333346|OTHER||Mean Difference (Final Values)|-29.7|||||TWO_SIDED|95.0|-141.9|82.6|||||Controlled for lean mass. Reported values are outputted by STATA.|||82.6|-141.9|
91720174|NCT03043053|183333347|OTHER||Mean Difference (Final Values)|196.0|||||TWO_SIDED|95.0|-1036.0|1428.0||||||||1428|-1036|
91487878|NCT01904058|182847985|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.438|TWO_SIDED|95.0|-14.2|6.23||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.||6.23|-14.20|0.4380
91487879|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.09||||0.42|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 3||||0.42
91487880|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.32|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 3||||0.32
91487881|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.36|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 3||||0.36
91487882|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.17||||0.23|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Regimen-Related Distress Subscale - Treatment Effect - Month 3||||0.23
91487883|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression model with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.18||||0.26|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 3||||0.26
91487884|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Treatment Effect|0.007||||0.95|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 6||||0.95
91487885|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.01||||0.92|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 6||||0.92
91487886|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.07||||0.59|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 6||||0.59
91487887|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.08||||0.54|TWO_SIDED|||||alpha = 0.05|Interaction Term|||Regimen-Related Distress Subscale - Treatment Effect - Month 6||||0.54
91487888|NCT04041375|182848004|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.3||||0.05|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 6||||0.05
91487889|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.58||||0.03|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 3||||0.03
91527042|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.1|1.15||||||Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels||1.15|0.10|
91720175|NCT03043053|183333348|OTHER||Mean Difference (Final Values)|-152.0|||||TWO_SIDED|95.0|-302.3|-1.7||||||||-1.7|-302.3|
91487890|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.07||||0.83|TWO_SIDED||||||Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3||||0.83
91527043|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.23|2.03||||||Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels||2.03|0.23|
91686611|NCT00879255|183265388|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-5.56|||>|0.05|TWO_SIDED|95.0|-16.26|5.14||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority test|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||5.14|-16.26|> .05
91686612|NCT01499095|183265401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.139|0.119||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.119|-0.139|
91686613|NCT01499095|183265402|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.77||||0.038|TWO_SIDED|95.0|0.61|0.99|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.99|0.61|0.0380
91686614|NCT01499095|183265403|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.201||0.8279|TWO_SIDED|95.0|-0.438|0.35|||ANCOVA|||Change in pre-injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.||0.350|-0.438|0.8279
91686615|NCT01499095|183265412|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.152|0.415||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.||0.415|-0.152|
91686616|NCT02099786|183265500|SUPERIORITY||Odds Ratio (OR)|2.2||||0.27|TWO_SIDED|95.0|0.55|8.8|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with ASHA-significant threshold shifts between treatment arms.||8.8|.55|.27
91686617|NCT02099786|183265500|SUPERIORITY||Odds Ratio (OR)|1.4||||0.67|TWO_SIDED|95.0|0.3|5.9|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with CTCAE grade 1 or greater hearing loss between treatment arms.||5.9|.3|.67
91686618|NCT02099786|183265501|SUPERIORITY||Odds Ratio (OR)|0.92||||0.88|TWO_SIDED|95.0|0.29|2.9|||Regression, Logistic|||Null hypothesis is no difference in audiology clinic use between treatment arms.||2.9|.29|.88
91686619|NCT02099786|183265502|NON_INFERIORITY|We require a non-inferiority margin of no more than 1.1 mortality odds among COMP-VA patients relative to Usual Care patients. This means that the upper 95% confidence bound for the fitted odds ratio must be less than 1.1 to reject the null hypothesis that COMP-VA induces extra mortality risk.|Odds Ratio (OR)|1.9|||||ONE_SIDED|||||||||||||
91686620|NCT02099786|183265503|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance is .05|t-test, 2 sided|||||||.72
91686621|NCT03052751|183265504|SUPERIORITY||LS Mean Difference vs Placebo|-0.7|||=|0.221|ONE_SIDED|95.0||0.8||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.8||=0.221
91686622|NCT03052751|183265505|SUPERIORITY||LS Mean Difference vs Placebo|-1.8|||=|0.089|ONE_SIDED|95.0||0.4||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.4||=0.089
91686623|NCT03052751|183265506|SUPERIORITY||LS Mean Difference vs Placebo|-1.4|||=|0.036|ONE_SIDED|95.0||-0.1||One-sided p-value was presented for difference.|ANCOVA||Estimate included treatment effect.|ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.||-0.1||=0.036
91686624|NCT03071692|183265530|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.92|1.16||||||||1.16|0.92|
91527044|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.19|1.68||||||Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels||1.68|0.19|
91487891|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.44||||0.12|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 3||||0.12
91527045|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.38|3.7||||||Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels||3.70|0.38|
91686625|NCT03071692|183265531|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.92|1.2||||||||1.20|0.92|
91686626|NCT03071692|183265532|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
91686627|NCT03071692|183265533|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16||||||||1.16|0.93|
91686628|NCT03071692|183265534|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13||||||||1.13|0.93|
91686629|NCT03071692|183265535|SUPERIORITY||Event Rate Ration|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||||1.13|0.87|
91686630|NCT03071692|183265536|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.09||||||||1.09|0.69|
91686631|NCT03071692|183265537|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.95|1.41||||||||1.41|0.95|
91686632|NCT03071692|183265538|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.19||||||||1.19|0.69|
91686633|NCT03071692|183265539|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.14||||||||1.14|0.84|
91686634|NCT03071692|183265540|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.32||||||||1.32|0.83|
91686635|NCT03071692|183265541|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.75|1.26||||||TT Variant||1.26|0.75|
91686636|NCT03071692|183265541|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||CT Variant||1.47|0.96|
91686637|NCT03071692|183265541|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.69|1.39||||||CC Variant||1.39|0.69|
91686638|NCT03071692|183265542|SUPERIORITY|||||||0.13496|||||||ANCOVA|||||||0.13496
91686639|NCT03071692|183265543|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91686640|NCT03071692|183265544|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91686641|NCT03071692|183265545|SUPERIORITY|||||||0.96689|||||||ANCOVA|||||||0.96689
91527046|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.26|1.89||||||Placebo versus Asacol for Week 4 fecal lactoferrin levels||1.89|0.26|
91527047|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.27|4.07||||||Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels||4.07|0.27|
91686642|NCT03071692|183265546|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91686643|NCT03071692|183265547|SUPERIORITY|||||||0.09178|||||||ANCOVA|||||||0.09178
91686644|NCT03071692|183265548|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91686645|NCT03071692|183265549|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91686646|NCT03071692|183265550|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91686647|NCT01027702|183265556|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~* If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~* If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~* If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
91686648|NCT01027702|183265557|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
91686649|NCT00403585|183265559|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 156.|Wilcoxon signed rank|||||||<0.001
91686650|NCT03022370|183265580|SUPERIORITY||Odds Ratio (OR)|0.92|||=|0.686|TWO_SIDED|95.0|0.62|1.37|||Regression, Logistic|||||1.37|0.62|=0.686
91686651|NCT03022370|183265580|SUPERIORITY||Odds Ratio (OR)|0.71|||=|0.032|TWO_SIDED|95.0|0.51|0.97|||Regression, Logistic|||||0.97|0.51|=0.032
91686652|NCT03022370|183265581|SUPERIORITY||Odds Ratio (OR)|0.9||||0.555|TWO_SIDED|95.0|0.64|1.28|||Regression, Logistic|||||1.28|0.64|0.555
91686653|NCT03022370|183265581|SUPERIORITY||Odds Ratio (OR)|0.74||||0.072|TWO_SIDED|95.0|0.54|1.03|||Regression, Logistic|||||1.03|0.54|0.072
91720176|NCT02139540|183333352|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)||||<0.05
91686654|NCT03022370|183265582|SUPERIORITY||Odds Ratio (OR)|0.93||||0.672|TWO_SIDED|95.0|0.66|1.31|||Regression, Logistic|||||1.31|0.66|0.672
91686655|NCT03022370|183265582|SUPERIORITY||Odds Ratio (OR)|0.7||||0.019|TWO_SIDED|95.0|0.52|0.94|||Regression, Logistic|||||0.94|0.52|0.019
91686656|NCT03022370|183265583|SUPERIORITY||Slope|-0.01||||0.984|TWO_SIDED|95.0|-0.88|0.86|||Regression, Linear|||||0.86|-0.88|0.984
91720177|NCT02139540|183333353|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91720178|NCT03533751|183333354|SUPERIORITY||Least Squares (LS) Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|10.235||0.4498|TWO_SIDED|95.0|-12.4066|27.8983|||ANCOVA|The p-value was obtained using a mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||27.8983|-12.4066|0.4498
91720179|NCT03533751|183333354|SUPERIORITY||LS Mean Difference|-6.32|STANDARD_ERROR_OF_MEAN|9.39||0.501|TWO_SIDED|95.0|-24.774|12.1262|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||12.1262|-24.7740|0.5010
91720180|NCT03533751|183333354|SUPERIORITY||LS Mean Difference|1.97|STANDARD_ERROR_OF_MEAN|9.454||0.8349|TWO_SIDED|95.0|-16.6037|20.5476|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||20.5476|-16.6037|0.8349
91720181|NCT03533751|183333354|SUPERIORITY||LS Mean Difference|4.82|STANDARD_ERROR_OF_MEAN|11.154||0.6662|TWO_SIDED|95.0|-17.1892|26.8275|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||26.8275|-17.1892|0.6662
91720182|NCT03533751|183333355|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7992|TWO_SIDED|95.0|0.42|1.9509|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.9509|0.4200|0.7992
91720183|NCT03533751|183333355|SUPERIORITY||Odds Ratio (OR)|1.59||||0.2197|TWO_SIDED|95.0|0.757|3.3572|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.3572|0.7570|0.2197
91720184|NCT03533751|183333355|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7197|TWO_SIDED|95.0|0.5345|2.4774|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.4774|0.5345|0.7197
91720185|NCT03533751|183333355|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6772|TWO_SIDED|95.0|0.391|1.8404|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.8404|0.3910|0.6772
91720186|NCT03533751|183333356|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9537|TWO_SIDED|95.0|0.3922|2.6994|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.6994|0.3922|0.9537
91720187|NCT03533751|183333356|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3316|TWO_SIDED|95.0|0.6323|3.8895|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.8895|0.6323|0.3316
91720188|NCT03533751|183333356|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5166|TWO_SIDED|95.0|0.5331|3.4944|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.4944|0.5331|0.5166
91720189|NCT03533751|183333356|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7426|TWO_SIDED|95.0|0.4545|3.0223|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.0223|0.4545|0.7426
91686657|NCT03022370|183265583|SUPERIORITY||Slope|0.06||||0.839|TWO_SIDED|95.0|-0.51|0.63|||Regression, Linear|||||0.63|-0.51|0.839
91686658|NCT03022370|183265584|SUPERIORITY||Slope|0.97|||<|0.0001|TWO_SIDED|95.0|0.43|1.51|||Tobit|Log + 1 performed on data||||1.51|0.43|<0.0001
91686659|NCT03022370|183265584|SUPERIORITY||Slope|0.21||||0.521|TWO_SIDED|95.0|-0.42|0.83|||Tobit|Log plus 1 to transform data||||0.83|-0.42|0.521
91686660|NCT03022370|183265585|SUPERIORITY||Slope|0.25||||0.718|TWO_SIDED|95.0|-1.09|1.58|||Regression, Linear|||||1.58|-1.09|0.718
91686661|NCT03022370|183265585|SUPERIORITY||Slope|-0.3||||0.712|TWO_SIDED|95.0|-1.87|1.28|||Regression, Linear|||||1.28|-1.87|0.712
91686662|NCT03022370|183265586|SUPERIORITY||Slope|-1.52||||0.067|TWO_SIDED|95.0|-3.14|0.11|||Regression, Linear|||||0.11|-3.14|0.067
91686663|NCT03022370|183265586|SUPERIORITY||Slope|-0.75||||0.398|TWO_SIDED|95.0|-2.48|0.99|||Regression, Linear|||||0.99|-2.48|0.398
91686664|NCT03022370|183265587|SUPERIORITY||Odds Ratio (OR)|1.29||||0.228|TWO_SIDED|95.0|0.85|1.97|||Regression, Logistic|||||1.97|0.85|0.228
91720190|NCT03533751|183333357|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4543|TWO_SIDED|95.0|0.3998|7.7615|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||7.7615|0.3998|0.4543
91720191|NCT03533751|183333357|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1874|TWO_SIDED|95.0|0.6314|10.4827|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||10.4827|0.6314|0.1874
91720192|NCT03533751|183333357|SUPERIORITY||Odds Ratio (OR)|2.69||||0.1721|TWO_SIDED|95.0|0.6506|11.0814|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||11.0814|0.6506|0.1721
91720193|NCT03533751|183333357|SUPERIORITY||Odds Ratio (OR)|0.68||||0.6755|TWO_SIDED|95.0|0.1086|4.2141|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||4.2141|0.1086|0.6755
91527048|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.48|||||TWO_SIDED|95.0|0.46|4.73||||||Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels||4.73|0.46|
91686665|NCT03022370|183265587|SUPERIORITY||Odds Ratio (OR)|0.86||||0.558|TWO_SIDED|95.0|0.53|1.41|||Regression, Logistic|||||1.41|0.53|0.558
91720194|NCT03533751|183333358|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6058|TWO_SIDED|95.0|0.2481|2.2543|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||2.2543|0.2481|0.6058
91720195|NCT03533751|183333358|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9521|TWO_SIDED|95.0|0.3356|2.7923|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.7923|0.3356|0.9521
91720196|NCT03533751|183333358|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6905|TWO_SIDED|95.0|0.4457|3.3878|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||3.3878|0.4457|0.6905
91487892|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.39||||0.17|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 3||||0.17
91527049|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.11|1.02||||||Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels||1.02|0.11|
91527050|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.16|||||TWO_SIDED|95.0|0.36|3.73||||||Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels||3.73|0.36|
91686666|NCT03022370|183265588|SUPERIORITY||Slope|0.14||||0.679|TWO_SIDED|95.0|-0.52|0.8|||Regression, Linear|||||0.80|-0.52|0.679
91686667|NCT03022370|183265588|SUPERIORITY||Slope|0.55||||0.08|TWO_SIDED|95.0|-0.07|1.16|||Regression, Linear|||||1.16|-0.07|0.08
91686668|NCT03022370|183265589|SUPERIORITY||Slope|-0.13||||0.81|TWO_SIDED|95.0|-1.21|0.95|||Regression, Linear|||||0.95|-1.21|0.810
91686669|NCT03022370|183265589|SUPERIORITY||Slope|-1.03||||0.041|TWO_SIDED|95.0|-2.01|-0.04|||Regression, Linear|||||-0.04|-2.01|0.041
91686670|NCT03022370|183265590|SUPERIORITY||Odds Ratio (OR)|1.14||||0.635|TWO_SIDED|95.0|0.67|1.92|||Regression, Logistic|||||1.92|0.67|0.635
91686671|NCT03022370|183265590|SUPERIORITY||Odds Ratio (OR)|0.72||||0.256|TWO_SIDED|95.0|0.41|1.27|||Regression, Logistic|||||1.27|0.41|0.256
91686672|NCT03022370|183265591|SUPERIORITY||Odds Ratio (OR)|1.16||||0.526|TWO_SIDED|95.0|0.73|1.84|||Regression, Logistic|||||1.84|0.73|0.526
91720197|NCT03533751|183333358|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9399|TWO_SIDED|95.0|0.3671|2.9518|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.9518|0.3671|0.9399
91527051|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.29|2.33||||||Placebo versus Asacol for Week 5 fecal lactoferrin levels||2.33|0.29|
91686673|NCT03022370|183265591|SUPERIORITY||Odds Ratio (OR)|1.02||||0.931|TWO_SIDED|95.0|0.67|1.56|||Regression, Logistic|||||1.56|0.67|0.931
91686674|NCT03022370|183265592|SUPERIORITY||Odds Ratio (OR)|0.92||||0.691|TWO_SIDED|95.0|0.63|1.36|||Regression, Logistic|||||1.36|0.63|0.691
91686675|NCT03022370|183265592|SUPERIORITY||Odds Ratio (OR)|0.92||||0.692|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||||1.40|0.60|0.692
91686676|NCT03022370|183265593|SUPERIORITY||Slope|-0.31||||0.137|TWO_SIDED|95.0|-0.72|0.24|||Regression, Linear|||||0.24|-0.72|0.137
91686677|NCT03022370|183265593|SUPERIORITY||Slope|-0.09||||0.721|TWO_SIDED|95.0|-0.58|0.4|||Regression, Linear|||||0.40|-0.58|0.721
91686678|NCT03022370|183265594|SUPERIORITY||Slope|-0.23||||0.332|TWO_SIDED|95.0|-0.7|0.24|||Regression, Linear|||||0.24|-0.70|0.332
91686679|NCT03022370|183265594|SUPERIORITY||Slope|-0.19||||0.468|TWO_SIDED|95.0|-0.71|0.32|||Regression, Linear|||||0.32|-0.71|0.468
91686680|NCT03022370|183265595|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
91686681|NCT03022370|183265595|SUPERIORITY||Odds Ratio (OR)|1.49||||0.129|TWO_SIDED|95.0|0.89|2.5|||Regression, Logistic|||||2.50|0.89|0.129
91686682|NCT03022370|183265596|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
91686683|NCT03022370|183265596|SUPERIORITY||Odds Ratio (OR)|0.96||||0.836|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||||1.43|0.64|0.836
91686684|NCT01526655|183265599|SUPERIORITY|||||||0.011||||||Main effect over time p\<0.001; Interaction effect p=0.65. Threshold for statistical significance p\<0.05|ANOVA|||||||0.011
91686685|NCT01526655|183265600|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p 0.02.~Threshold for statistical significance p\<0.05."|ANOVA||||Tukey post hoc test (p-values): hsCRP time 4 p 0.02; hsCRP time 5 p \<0.001.|||0.03
91686686|NCT01526655|183265601|SUPERIORITY||||||<|0.01||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.0001.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): WBC time 3 p \< 0.0001.|||<0.01
91686687|NCT01526655|183265602|SUPERIORITY|||||||0.03|||||||ANOVA||||Tukey post hoc test (p-value): IL-6 time 3 p \< 0.01.|||0.03
91686688|NCT01526655|183265603|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): CK time 4 p \< 0.0001.|||0.03
91686689|NCT01526655|183265604|SUPERIORITY|||||||0.06||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): cortisol time 3 p \< 0.0001.|||0.06
91686690|NCT01526655|183265605|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91686691|NCT01526655|183265606|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91686692|NCT01894087|183265671|SUPERIORITY||Incidence Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Numerator is Therapist-led Brief Intervention, Denominator is Enhanced Usual Care only.|Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome||0.87|0.59|
91527052|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.44|||||TWO_SIDED|95.0|0.31|6.59||||||Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels||6.59|0.31|
91686693|NCT01894087|183265672|SUPERIORITY||Slope|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Numerator is the Therapist-Led Brief Intervention and Denominator is Enhanced Usual Care only|Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.||0.40|-0.20|
91720198|NCT03533751|183333359|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7659|TWO_SIDED|95.0|0.329|4.5268|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as covariate.||||4.5268|0.3290|0.7659
91720199|NCT03533751|183333359|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6273|TWO_SIDED|95.0|0.3895|4.776|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||4.7760|0.3895|0.6273
91720200|NCT03533751|183333359|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2967|TWO_SIDED|95.0|0.5734|6.1879|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||6.1879|0.5734|0.2967
91720201|NCT03533751|183333359|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5544|TWO_SIDED|95.0|0.4152|5.1476|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||5.1476|0.4152|0.5544
91686694|NCT01894087|183265673|SUPERIORITY||Incidence Rate Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of using opioids as prescribed). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.||1.33|0.93|
91720202|NCT03533751|183333360|SUPERIORITY||Odds Ratio (OR)|1.12||||0.86|TWO_SIDED|95.0|0.3175|3.9513|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||3.9513|0.3175|0.8600
91686695|NCT01894087|183265673|SUPERIORITY||Incidence Rate Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.||0.90|0.65|
91686696|NCT01894087|183265673|SUPERIORITY||Incidence Rate Ratio|0.97|||||TWO_SIDED|95.0|0.8|1.19|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.||1.19|0.80|
91686697|NCT01894087|183265674|SUPERIORITY||Incidence Rate Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.92|||||Numerator is Therapist-Led Brief Intervention, Denominator is Enhanced Usual Care only|Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome||0.92|0.70|
91686698|NCT04020887|183265705|SUPERIORITY||Median Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-6.01|18.01||||||Difference in time to PACU discharge determination from observation to interaction phase \[ Time Frame: 6 months\]: The difference in discharge readiness time between the observation and interaction phases will be compared.||18.01|-6.01|
91686699|NCT04020887|183265706|SUPERIORITY||Difference Between Proportions|29.8|||||TWO_SIDED|95.0|23.82|35.66||||||||35.66|23.82|
91720203|NCT03533751|183333360|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3222|TWO_SIDED|95.0|0.5511|6.1214|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1214|0.5511|0.3222
91686700|NCT04020887|183265707|SUPERIORITY||Difference Between Proportions|-2.67|||||TWO_SIDED|95.0|-8.18|3.02||||||||3.02|-8.18|
91686701|NCT04020887|183265708|SUPERIORITY||Difference Between Proportions|13.03|||||TWO_SIDED|95.0|5.16|20.79||||||||20.79|5.16|
91686702|NCT04020887|183265709|SUPERIORITY||Difference Between Proportions|0.51|||||TWO_SIDED|95.0|-1.63|3.07||||||||3.07|-1.63|
91686703|NCT04020887|183265710|SUPERIORITY||Difference Between Proportions|7.9|||||TWO_SIDED|95.0|3.13|12.71||||||||12.71|3.13|
91686704|NCT02006732|183265753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.261|0.336|||Mixed Effects Model for Repeated Measure|||||0.336|0.261|<0.0001
91686705|NCT02006732|183265753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.069|0.141|||Mixed Effects Model for Repeated Measure|||||0.141|0.069|<0.0001
91686706|NCT02006732|183265753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.246|0.323|||Mixed Effects Model for Repeated Measure|||||0.323|0.246|<0.0001
91686707|NCT02006732|183265753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||Mixed Effects Model for Repeated Measure|||||0.128|0.053|<0.0001
91720204|NCT03533751|183333360|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2564|TWO_SIDED|95.0|0.6089|6.431|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.4310|0.6089|0.2564
91720205|NCT03533751|183333360|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2912|TWO_SIDED|95.0|0.5806|6.1275|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1275|0.5806|0.2912
91720206|NCT03533751|183333361|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|8.679||0.8927|TWO_SIDED|95.0|-18.2117|15.8686|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||15.8686|-18.2117|0.8927
91527053|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|2.21|||||TWO_SIDED|95.0|0.54|9.04||||||Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels||9.04|0.54|
91686708|NCT02006732|183265753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.156|0.232|||Mixed Effects Model for Repeated Measure|||||0.232|0.156|<0.0001
91686709|NCT02006732|183265753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.019||0.4499|TWO_SIDED|95.0|-0.023|0.051|||Mixed Effects Model for Repeated Measure|||||0.051|-0.023|0.4499
91686710|NCT02006732|183265754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.129|0.203|||Mixed Effects Model for Repeated Measure|||||0.203|0.129|<0.0001
91686711|NCT02006732|183265754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.019||0.0395|TWO_SIDED|95.0|0.002|0.076|||Mixed Effects Model for Repeated Measure|||||0.076|0.002|0.0395
91686712|NCT02006732|183265754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.132|0.207|||Mixed Effects Model for Repeated Measure|||||0.207|0.132|<0.0001
91720207|NCT03533751|183333361|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|9.019||0.7035|TWO_SIDED|95.0|-14.2767|21.1463|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||21.1463|-14.2767|0.7035
91686713|NCT02006732|183265754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.0269|TWO_SIDED|95.0|0.005|0.079|||Mixed Effects Model for Repeated Measure|||||0.079|0.005|0.0269
91686714|NCT02006732|183265754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.09|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.090|<0.0001
91686715|NCT02006732|183265754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019||0.8669|TWO_SIDED|95.0|-0.04|0.034|||Mixed Effects Model for Repeated Measure|||||0.034|-0.040|0.8669
91686716|NCT02006732|183265755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.564|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|-6.499|-2.629|||Mixed Effects Model for Repeated Measure|||||-2.629|-6.499|<0.0001
91686717|NCT02006732|183265755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.974||0.078|TWO_SIDED|95.0|-3.628|0.193|||Mixed Effects Model for Repeated Measure|||||0.193|-3.628|0.0780
91686718|NCT02006732|183265755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.666|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.611|-1.721|||Mixed Effects Model for Repeated Measure|||||-1.721|-5.611|0.0002
91686719|NCT02006732|183265755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.979||0.4028|TWO_SIDED|95.0|-2.741|1.102|||Mixed Effects Model for Repeated Measure|||||1.102|-2.741|0.4028
91686720|NCT02006732|183265755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.993||0.0042|TWO_SIDED|95.0|-4.796|-0.897|||Mixed Effects Model for Repeated Measure|||||-0.897|-4.796|0.0042
91686721|NCT02006732|183265755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.898|STANDARD_ERROR_OF_MEAN|0.971||0.3555|TWO_SIDED|95.0|-2.804|1.008|||Mixed Effects Model for Repeated Measure|||||1.008|-2.804|0.3555
91686722|NCT02006732|183265756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.668|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-6.06|-3.276|||Mixed Effects Model for Repeated Measure|||||-3.276|-6.060|<0.0001
91686723|NCT02006732|183265756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.097|STANDARD_ERROR_OF_MEAN|0.701||0.0028|TWO_SIDED|95.0|-3.471|-0.723|||Mixed Effects Model for Repeated Measure|||||-0.723|-3.471|0.0028
91686724|NCT02006732|183265756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.846|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.24|-2.451|||Mixed Effects Model for Repeated Measure|||||-2.451|-5.240|<0.0001
91686725|NCT02006732|183265756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|STANDARD_ERROR_OF_MEAN|0.702||0.0696|TWO_SIDED|95.0|-2.651|0.102|||Mixed Effects Model for Repeated Measure|||||0.102|-2.651|0.0696
91720208|NCT03533751|183333361|SUPERIORITY||LS Mean Difference|-9.27|STANDARD_ERROR_OF_MEAN|8.608||0.2819|TWO_SIDED|95.0|-26.159|7.6237|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||7.6237|-26.1590|0.2819
91686726|NCT02006732|183265756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|0.714||0.0003|TWO_SIDED|95.0|-3.971|-1.171|||Mixed Effects Model for Repeated Measure|||||-1.171|-3.971|0.0003
91686727|NCT02006732|183265756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.822|STANDARD_ERROR_OF_MEAN|0.698||0.2387|TWO_SIDED|95.0|-2.191|0.546|||Mixed Effects Model for Repeated Measure|||||0.546|-2.191|0.2387
91686728|NCT02006732|183265757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.187|0.317|||Mixed Effects Model for Repeated Measure|||||0.317|0.187|<0.0001
91686729|NCT02006732|183265757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.033||0.0614|TWO_SIDED|95.0|-0.003|0.125|||Mixed Effects Model for Repeated Measure|||||0.125|-0.003|0.0614
91686730|NCT02006732|183265757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.24|0.37|||Mixed Effects Model for Repeated Measure|||||0.370|0.240|<0.0001
91686731|NCT02006732|183265757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.033||0.0005|TWO_SIDED|95.0|0.049|0.178|||Mixed Effects Model for Repeated Measure|||||0.178|0.049|0.0005
91686732|NCT02006732|183265757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.126|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|0.126|<0.0001
91686733|NCT02006732|183265757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.033||0.1089|TWO_SIDED|95.0|-0.117|0.012|||Mixed Effects Model for Repeated Measure|||||0.012|-0.117|0.1089
91686734|NCT02006732|183265758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.195|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.665|1.725|||Mixed Effects Model for Repeated Measure|||||1.725|0.665|<0.0001
91686735|NCT02006732|183265758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.267||0.0296|TWO_SIDED|95.0|0.058|1.106|||Mixed Effects Model for Repeated Measure|||||1.106|0.058|0.0296
91686736|NCT02006732|183265758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|0.73|1.796|||Mixed Effects Model for Repeated Measure|||||1.796|0.730|<0.0001
91686737|NCT02006732|183265758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.269||0.0159|TWO_SIDED|95.0|0.122|1.178|||Mixed Effects Model for Repeated Measure|||||1.178|0.122|0.0159
91686738|NCT02006732|183265758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.613|STANDARD_ERROR_OF_MEAN|0.273||0.0248|TWO_SIDED|95.0|0.078|1.148|||Mixed Effects Model for Repeated Measure|||||1.148|0.078|0.0248
91686739|NCT02006732|183265758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.266||0.7984|TWO_SIDED|95.0|-0.59|0.454|||Mixed Effects Model for Repeated Measure|||||0.454|-0.590|0.7984
91686740|NCT02006732|183265759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.623|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.245|2.0|||Mixed Effects Model for Repeated Measure|||||2.000|1.245|<0.0001
91686741|NCT02006732|183265759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|0.22|0.967|||Mixed Effects Model for Repeated Measure|||||0.967|0.220|0.0019
91487893|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.85|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 3||||0.85
91686742|NCT02006732|183265759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.611|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.232|1.989|||Mixed Effects Model for Repeated Measure|||||1.989|1.232|<0.0001
91686743|NCT02006732|183265759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.191||0.0023|TWO_SIDED|95.0|0.207|0.956|||Mixed Effects Model for Repeated Measure|||||0.956|0.207|0.0023
91686744|NCT02006732|183265759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.649|1.41|||Mixed Effects Model for Repeated Measure|||||1.410|0.649|<0.0001
91686745|NCT02006732|183265759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.189||0.9494|TWO_SIDED|95.0|-0.359|0.383|||Mixed Effects Model for Repeated Measure|||||0.383|-0.359|0.9494
91720209|NCT03533751|183333361|SUPERIORITY||LS Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|8.557||0.4793|TWO_SIDED|95.0|-22.8452|10.7333|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||10.7333|-22.8452|0.4793
91527054|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels||1.48|0.11|
91686746|NCT02006732|183265760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.366|0.498|||Mixed Effects Model for Repeated Measure|||||0.498|0.366|<0.0001
91686747|NCT02006732|183265760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.084|0.212|||Mixed Effects Model for Repeated Measure|||||0.212|0.084|<0.0001
91686748|NCT02006732|183265760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.387|0.522|||Mixed Effects Model for Repeated Measure|||||0.522|0.387|<0.0001
91686749|NCT02006732|183265760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.105|0.236|||Mixed Effects Model for Repeated Measure|||||0.236|0.105|<0.0001
91686750|NCT02006732|183265760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.217|0.35|||Mixed Effects Model for Repeated Measure|||||0.350|0.217|<0.0001
91686751|NCT02006732|183265760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.033||0.4974|TWO_SIDED|95.0|-0.087|0.042|||Mixed Effects Model for Repeated Measure|||||0.042|-0.087|0.4974
91686752|NCT00825786|183265761|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.46|1.09|||Log Rank||group 2 vs. group 1 (sequential vs combined)|||1.09|0.46|0.14
91686753|NCT00825786|183265762|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
91686754|NCT00825786|183265763|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
91720210|NCT03533751|183333362|SUPERIORITY||LS Mean Difference|6.57|STANDARD_ERROR_OF_MEAN|6.677||0.3262|TWO_SIDED|95.0|-6.5723|19.7054|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||19.7054|-6.5723|0.3262
91720211|NCT03533751|183333362|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|6.366||0.8465|TWO_SIDED|95.0|-13.7439|11.2782|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||11.2782|-13.7439|0.8465
91720212|NCT03533751|183333362|SUPERIORITY||LS Mean Difference|2.51|STANDARD_ERROR_OF_MEAN|6.396||0.6947|TWO_SIDED|95.0|-10.0587|15.082|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.||||15.0820|-10.0587|0.6947
91527055|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|1.64|||||TWO_SIDED|95.0|0.46|5.91||||||Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels||5.91|0.46|
91686755|NCT00825786|183265764|SUPERIORITY|||||||0.6|||||||ANCOVA|||||||0.60
91686756|NCT00825786|183265765|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
91686757|NCT00825786|183265766|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
91686758|NCT00825786|183265767|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
91686759|NCT02969044|183265768|SUPERIORITY||Mean Difference (Net)|-9.25|||<|0.001|TWO_SIDED|95.0|-14.75|-3.79|||ANCOVA|||||-3.79|-14.75|<0.001
91686760|NCT02359994|183265850|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in percentage of participants|-1.4||||0.005|TWO_SIDED|95.0|-7.5|4.8|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The primary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 7 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 7 minutes in the Arista group, the active control.||4.8|-7.5|0.005
91686761|NCT02359994|183265851|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in Percentage of Participants|4.8|||<|0.001|TWO_SIDED|95.0|-2.4|12.0|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The secondary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 5 minutes in the Arista group, the active control.||12.0|-2.4|<0.001
91686762|NCT02766283|183265872|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
91686763|NCT02766283|183265873|SUPERIORITY_OR_OTHER|||||||0.022|||||||Chi-squared|||||||0.022
91686764|NCT02448368|183265883|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio|232.0|||||TWO_SIDED|90.0|202.0|266.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||266|202|
91686765|NCT02448368|183265883|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|181.0|||||TWO_SIDED|90.0|164.0|200.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||200|164|
91686766|NCT02448368|183265883|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|106.0|||||TWO_SIDED|90.0|91.5|124.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||124|91.5|
91686767|NCT02448368|183265885|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|147.0|195.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||195|147|
91686768|NCT02448368|183265885|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|146.0|199.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||199|146|
91686769|NCT02448368|183265885|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|129.0|||||TWO_SIDED|90.0|114.0|146.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||146|114|
91686770|NCT02448368|183265886|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|161.0|||||TWO_SIDED|90.0|139.0|187.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||187|139|
91686771|NCT02448368|183265886|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|159.0|||||TWO_SIDED|90.0|135.0|188.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||188|135|
91686772|NCT02448368|183265886|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|131.0|||||TWO_SIDED|90.0|116.0|147.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||147|116|
91686773|NCT02448368|183265888|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.4|||||TWO_SIDED|90.0|88.3|112.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||112|88.3|
91686774|NCT02448368|183265888|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.9|||||TWO_SIDED|90.0|85.5|117.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||117|85.5|
91686775|NCT02448368|183265888|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|116.0|||||TWO_SIDED|90.0|94.8|143.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||143|94.8|
91686776|NCT02448368|183265889|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.3|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.3|
91686777|NCT02448368|183265889|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|104.0|||||TWO_SIDED|90.0|95.0|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|95.0|
91487894|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.02||||0.94|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 3||||0.94
91686778|NCT02448368|183265889|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|115.0|||||TWO_SIDED|90.0|95.3|140.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||140|95.3|
91487895|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.47|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 6||||0.47
91686779|NCT02448368|183265890|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.1|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.1|
91686780|NCT02448368|183265890|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|103.0|||||TWO_SIDED|90.0|94.6|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|94.6|
91686781|NCT02448368|183265890|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|113.0|||||TWO_SIDED|90.0|93.3|137.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||137|93.3|
91686782|NCT03086551|183265896|OTHER||Effect Size - Cohen's d|0.2|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.||||
91686783|NCT03086551|183265896|OTHER||Effect Size - Cohen's d|0.69|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.||||
91686784|NCT03086551|183265896|OTHER|Cohen's d effect size was calculated to compare the magnitude of change in time to complete the movement sequence from pre-baseline to post-intervention across the Active and Sham arms.|Effect Size - Cohen's d|-0.8|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|||||
91686785|NCT03086551|183265897|OTHER||Effect Size - Cohen's d|-0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
91686786|NCT03086551|183265897|OTHER||Effect Size - Cohen's d|0.5|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
91686787|NCT03086551|183265897|OTHER||Effect Size - Cohen's d|-1.84|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
91686788|NCT03086551|183265897|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
91527056|NCT01036022|182929429|SUPERIORITY_OR_OTHER||Ratio|0.84|||||TWO_SIDED|95.0|0.27|2.62||||||Placebo versus Asacol for Week 6 fecal lactoferrin levels||2.62|0.27|
91527653|NCT01976364|182930487|OTHER||LS mean difference|0.17|||||TWO_SIDED|95.0|-1.39|1.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.73|-1.39|
91720213|NCT03533751|183333362|SUPERIORITY||LS Mean Difference|6.76|STANDARD_ERROR_OF_MEAN|6.909||0.3288|TWO_SIDED|95.0|-6.8451|20.3626|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||20.3626|-6.8451|0.3288
91487896|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.08||||0.82|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6||||0.82
91487897|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 6||||0.66
91487898|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.25||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 6||||0.38
91487899|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.12||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 6||||0.68
91527654|NCT01976364|182930487|OTHER||LS mean difference|-0.53|||||TWO_SIDED|95.0|-2.15|1.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.08|-2.15|
91686789|NCT03086551|183265897|OTHER||Effect Size - Cohen's d|0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
91686790|NCT03086551|183265897|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
91686791|NCT03086551|183265898|OTHER||Effect Size - Cohen's d|-0.86|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
91686792|NCT03086551|183265898|OTHER||Effect Size - Cohen's d|-0.04|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
91686793|NCT03086551|183265898|OTHER||Effect Size - Cohen's d|-0.69|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
91686794|NCT03086551|183265898|OTHER||Effect Size - Cohen's d|0.28|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
91720214|NCT03533751|183333363|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.355||0.8497|TWO_SIDED|95.0|-2.4081|2.9218|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.9218|-2.4081|0.8497
91720215|NCT03533751|183333363|SUPERIORITY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|1.35||0.5016|TWO_SIDED|95.0|-3.5636|1.7473|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||1.7473|-3.5636|0.5016
91487900|NCT04041375|182848005|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.26||||0.4|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 6||||0.40
91487901|NCT04041375|182848007|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.93|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.93
91527655|NCT01976364|182930487|OTHER||LS mean difference|0.32|||||TWO_SIDED|95.0|-1.49|2.13||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.13|-1.49|
91686795|NCT03086551|183265899|OTHER||Effect Size - Cohen's d|-0.31|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
91686796|NCT03086551|183265899|OTHER||Effect Size - Cohen's d|-0.85|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
91686797|NCT03086551|183265899|OTHER||Effect Size - Cohen's d|-0.35|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
91686798|NCT03086551|183265899|OTHER||Effect Size - Cohen's d|1.13|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
91686799|NCT03086551|183265900|OTHER||Effect Size - Cohen's d|-0.15|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
91686800|NCT03086551|183265900|OTHER||Effect Size - Cohen's d|-1.46|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
91686801|NCT03736031|183265904|SUPERIORITY|||||||0.09|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.09
91686802|NCT03736031|183265905|SUPERIORITY|||||||0.81|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.81
91686803|NCT03736031|183265906|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
91686804|NCT03736031|183265907|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91686805|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.223|4.393|||||Hazard ratio comparing PFS of participants with a high expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4EBP1 Cytoplasm with PFS.||4.393|0.223|
91686806|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.071|||||TWO_SIDED|95.0|0.316|3.628|||||Hazard ratio comparing PFS of participants with a high expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4E Cytoplasm with PFS.||3.628|0.316|
91686807|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.658|||||TWO_SIDED|95.0|0.454|6.053|||||Hazard ratio comparing PFS of participants with a high expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker HDAC2 Nucleus with PFS.||6.053|0.454|
91686808|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.082|||||TWO_SIDED|95.0|0.455|36.628|||||Hazard ratio comparing PFS of participants with a high expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PCREB Nucleus with PFS.||36.628|0.455|
91487902|NCT04041375|182848007|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.63||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.38
91686809|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636|||||TWO_SIDED|95.0|0.18|2.253|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Cytoplasm with PFS.||2.253|0.180|
91487903|NCT04041375|182848008|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.32||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.66
91527656|NCT01976364|182930487|OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-1.89|1.86||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.86|-1.89|
91686810|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.362|||||TWO_SIDED|95.0|0.083|1.576|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Nucleus with PFS.||1.576|0.083|
91686811|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.522|||||TWO_SIDED|95.0|0.473|4.901|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS209 Cytoplasm with PFS.||4.901|0.473|
91686812|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.908|||||TWO_SIDED|95.0|0.223|3.699|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS65 Nucleus with PFS.||3.699|0.223|
91686813|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.843|||||TWO_SIDED|95.0|0.432|7.867|||||Hazard ratio comparing PFS of participants with a high expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFT70 Nucleus with PFS.||7.867|0.432|
91686814|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.276|3.109|||||Hazard ratio comparing PFS of participants with a high expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker P GSK3B Cytoplasm with PFS.||3.109|0.276|
91686815|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.985|||||TWO_SIDED|95.0|0.32|3.033|||||Hazard ratio comparing PFS of participants with a high expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PKCb2 Cytoplasm with PFS.||3.033|0.320|
91686816|NCT00451178|183265917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.817|||||TWO_SIDED|95.0|0.242|2.758|||||Hazard ratio comparing PFS of participants with a high expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PTEN Cytoplasm with PFS.||2.758|0.242|
91686817|NCT04856917|183265921|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.21||0.3757|TWO_SIDED|90.0|-2.47|8.19|||LRMM|||Least square (LS) Mean, SE, 90% CI, \& p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||8.19|-2.47|0.3757
91686818|NCT04856917|183265921|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|3.22||0.6183|TWO_SIDED|90.0|-3.73|6.95|||LRMM|||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||6.95|-3.73|0.6183
91686819|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.7||0.249|TWO_SIDED|90.0|-0.85|4.8||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||4.80|-0.85|0.2490
91686820|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.72||0.0708|TWO_SIDED|90.0|0.28|5.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.99|0.28|0.0708
91686821|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|2.68||0.004|TWO_SIDED|90.0|3.44|12.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||12.34|3.44|0.0040
91720216|NCT03533751|183333363|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.386||0.7511|TWO_SIDED|95.0|-3.167|2.287|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.2870|-3.1670|0.7511
91720217|NCT03533751|183333363|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.396||0.7558|TWO_SIDED|95.0|-2.3133|3.1824|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||3.1824|-2.3133|0.7558
91720218|NCT03454555|183333366|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.31|TWO_SIDED|95.0|-16.6|5.3|||Mixed Models Analysis|||||5.3|-16.6|0.31
91720219|NCT03454555|183333367|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.963|TWO_SIDED|95.0|-10.3|10.7|||Mixed Models Analysis|||||10.7|-10.3|0.963
91720220|NCT03454555|183333368|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.253|TWO_SIDED|95.0|-16.8|4.4|||Mixed Models Analysis|||||4.4|-16.8|0.253
91720221|NCT03454555|183333369|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.9|TWO_SIDED|95.0|-10.1|11.5|||Mixed Models Analysis|||||11.5|-10.1|0.90
91720222|NCT03454555|183333370|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.65|TWO_SIDED|95.0|-13.7|8.6|||Mixed Models Analysis|||||8.6|-13.7|0.65
91720223|NCT03454555|183333371|SUPERIORITY||Mean Difference (Final Values)|9.4||||0.102|TWO_SIDED|95.0|-1.9|20.8|||Mixed Models Analysis|||||20.8|-1.9|0.102
91720224|NCT03454555|183333372|SUPERIORITY||Odds Ratio (OR)|0.93||||0.83|TWO_SIDED|95.0|0.5|1.75|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.75|0.50|0.83
91487904|NCT04041375|182848008|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.99||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
91487905|NCT04041375|182848011|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.45||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.38
91487906|NCT04041375|182848011|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.64||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.68
91487907|NCT04041375|182848012|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.74|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.74
91720225|NCT03454555|183333373|SUPERIORITY||Odds Ratio (OR)|0.79||||0.47|TWO_SIDED|95.0|0.42|1.5|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.50|0.42|0.47
91720226|NCT03454555|183333374|SUPERIORITY||Odds Ratio (OR)|1.02||||0.96|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.90|0.54|0.96
91720227|NCT03454555|183333375|SUPERIORITY||Odds Ratio (OR)|0.71||||0.28|TWO_SIDED|95.0|0.38|1.33|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.33|0.38|0.28
91720228|NCT03454555|183333376|SUPERIORITY||Odds Ratio (OR)|0.9||||0.75|TWO_SIDED|95.0|0.47|1.71|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.71|0.47|0.75
91720229|NCT03454555|183333377|SUPERIORITY||Odds Ratio (OR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.31|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.31|0.35|0.25
91720230|NCT03454555|183333378|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.7|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.70
91720231|NCT03454555|183333379|SUPERIORITY||Median Difference (Final Values)|0.1||||0.92|TWO_SIDED|95.0|-1.1|1.2|||Mixed Models Analysis|||||1.2|-1.1|0.92
91720232|NCT03454555|183333380|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.64|TWO_SIDED|95.0|-0.7|1.2|||Mixed Models Analysis|||||1.2|-0.7|0.64
91720233|NCT03454555|183333381|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
91720234|NCT03454555|183333382|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.69
91720235|NCT03454555|183333383|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.33|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|0.33
91720236|NCT03454555|183333384|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||||1.5|-1.8|0.86
91720237|NCT03454555|183333385|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.4|1.9|||Mixed Models Analysis|||||1.9|-1.4|0.76
91720238|NCT03454555|183333386|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.55
91720239|NCT03454555|183333387|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.1|1.1|||Mixed Models Analysis|||||1.1|-2.1|0.52
91720240|NCT03454555|183333388|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.37|TWO_SIDED|95.0|-0.2|0.4|||Mixed Models Analysis|||||0.4|-0.2|0.37
91720241|NCT03454555|183333389|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.91|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.91
91720242|NCT03454555|183333390|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.33
91487908|NCT04041375|182848012|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.29||||0.62|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.62
91720243|NCT03454555|183333391|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.46
91720244|NCT03454555|183333392|SUPERIORITY||Risk Difference (RD)|-0.02||||0.52|TWO_SIDED|95.0|-0.08|0.04|||Chi-squared|||||0.04|-0.08|0.52
91720245|NCT03454555|183333393|SUPERIORITY||Odds Ratio (OR)|1.48||||0.17|TWO_SIDED|95.0|0.85|2.59|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.59|0.85|0.17
91720246|NCT03454555|183333394|SUPERIORITY||Odds Ratio (OR)|1.28||||0.41|TWO_SIDED|95.0|0.71|2.31|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.31|0.71|0.41
91720247|NCT03454555|183333395|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
91487909|NCT04041375|182848013|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.16||||0.72|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.72
91720248|NCT03454555|183333396|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
91720249|NCT00375752|183333455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.7||||0.106|TWO_SIDED|95.0|-1.8|31.1|||Fisher Exact|||||31.1|-1.8|0.106
91720250|NCT01140906|183333465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.66|-3.4||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.40|-7.66|<0.0001
91720251|NCT01140906|183333465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-9.21|-4.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-4.97|-9.21|<0.0001
91720252|NCT01140906|183333465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.45|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-11.55|-7.35||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-7.35|-11.55|<0.0001
91720253|NCT01140906|183333466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.76|4.47||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.47|1.76|<0.0001
91720254|NCT01140906|183333466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.1|5.36||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||5.36|2.10|<0.0001
91720255|NCT01140906|183333466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|3.61|9.78||This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted Odds Ratio|||||9.78|3.61|<0.0001
91720256|NCT01140906|183333467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.94|-0.44||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.44|-0.94|<0.0001
91720257|NCT01140906|183333467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.70|-1.20|<0.0001
91720258|NCT01140906|183333467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.36|-0.87||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-0.87|-1.36|<0.0001
91720259|NCT01140906|183333468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.53||0.0007|TWO_SIDED|95.0|-8.25|-2.22||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-2.22|-8.25|0.0007
91487910|NCT04041375|182848013|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.24||||0.58|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.58
91487911|NCT04041375|182848014|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.36||||0.5|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.50
91487912|NCT04041375|182848014|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.72||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
91487913|NCT01967342|182848017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.268|STANDARD_ERROR_OF_MEAN|-0.193||0.165|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.||||.165
91487914|NCT01967342|182848017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245|STANDARD_ERROR_OF_MEAN|0.198||0.216|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.||||.216
91487915|NCT01967342|182848017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.052|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.||||< .001
91487916|NCT01967342|182848017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.199||0.07|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.||||.070
91527657|NCT01976364|182930488|OTHER||LS mean difference|0.48|||||TWO_SIDED|95.0|-1.08|2.05||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.05|-1.08|
91686822|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.71||0.206|TWO_SIDED|90.0|-1.05|7.94||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||7.94|-1.05|0.2060
91686823|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.4341|TWO_SIDED|90.0|-2.33|6.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||6.51|-2.33|0.4341
91686824|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.73||0.7307|TWO_SIDED|90.0|-3.59|5.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||5.48|-3.59|0.7307
91686825|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.93||0.3261|TWO_SIDED|90.0|-1.97|7.77||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||7.77|-1.97|0.3261
91686826|NCT04856917|183265922|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.95||0.8221|TWO_SIDED|90.0|-5.56|4.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||4.23|-5.56|0.8221
91686827|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|6.2||0.3008|TWO_SIDED|90.0|-3.84|16.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||16.73|-3.84|0.3008
91722513|NCT05845619|183337875|SUPERIORITY|There was no power calculation because this was a pilot study.|Odds Ratio (OR)|1.21||||0.33|TWO_SIDED|95.0|0.83|1.76|||Regression, Logistic||Numerator: pilot; denominator: prospective controls|In this pilot study, we hypothesized that pilot participants would have a reduced risk of viremia 6 months after the intervention compared to controls.||1.76|0.83|0.33
91686828|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|6.27||0.0878|TWO_SIDED|90.0|0.4|21.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||21.19|0.40|0.0878
91686829|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|26.6|STANDARD_ERROR_OF_MEAN|8.42||0.002|TWO_SIDED|90.0|12.64|40.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||40.57|12.64|0.0020
91722514|NCT05845619|183337875|SUPERIORITY|No power calculation, pilot study.|Odds Ratio (OR)|1.25||||0.41|TWO_SIDED|95.0|0.73|2.14|||Regression, Logistic|||||2.14|0.73|0.41
91487917|NCT01967342|182848017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.823|STANDARD_ERROR_OF_MEAN|0.191|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
91487918|NCT01967342|182848017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.203||0.519|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.||||.519
91527658|NCT01976364|182930488|OTHER||LS mean difference|1.25|||||TWO_SIDED|95.0|-0.49|2.99||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.99|-0.49|
91686830|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|14.0|STANDARD_ERROR_OF_MEAN|8.5||0.1029|TWO_SIDED|90.0|-0.12|28.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||28.09|-0.12|0.1029
91686831|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|8.82||0.5427|TWO_SIDED|90.0|-9.25|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||20.02|-9.25|0.5427
91686832|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|9.06||0.5833|TWO_SIDED|90.0|-10.05|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||20.02|-10.05|0.5833
91686833|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|10.98||0.3293|TWO_SIDED|90.0|-7.46|28.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||28.99|-7.46|0.3293
91686834|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|10.99||0.19|TWO_SIDED|90.0|-3.74|32.74||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||32.74|-3.74|0.1900
91686835|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|11.7|STANDARD_ERROR_OF_MEAN|9.38||0.2168|TWO_SIDED|90.0|-3.91|27.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||27.23|-3.91|0.2168
91686836|NCT04856917|183265923|SUPERIORITY||LS Mean Difference|7.8|STANDARD_ERROR_OF_MEAN|9.42||0.4089|TWO_SIDED|90.0|-7.82|23.45||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||23.45|-7.82|0.4089
91686837|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.53||0.4229|TWO_SIDED|90.0|-2.16|6.24||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||6.24|-2.16|0.4229
91686838|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.56||0.6027|TWO_SIDED|90.0|-2.91|5.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.59|-2.91|0.6027
91722515|NCT02595892|183337876|OTHER||Hazard Ratio (HR)|0.57||||0.044|TWO_SIDED|90.0|0.33|0.98|||Log Rank|||||.98|.33|0.044
91686839|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.5||0.2655|TWO_SIDED|90.0|-1.35|6.95||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||6.95|-1.35|0.2655
91686840|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.53||0.6229|TWO_SIDED|90.0|-2.95|5.44||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||5.44|-2.95|0.6229
91686841|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.74||0.4091|TWO_SIDED|90.0|-3.1|9.3||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||9.30|-3.10|0.4091
91686842|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.83||0.1274|TWO_SIDED|90.0|-0.47|12.25||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||12.25|-0.47|0.1274
91722516|NCT02595892|183337879|OTHER|||||||0.44|||||||Fisher Exact|Two-Sided Fisher's exact test.||||||0.44
91487919|NCT01967342|182848018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.247||0.196|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.||||.196
91487920|NCT01967342|182848018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.182|STANDARD_ERROR_OF_MEAN|0.239||0.447|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.||||.447
91487921|NCT01967342|182848018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.643|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||<.001
91487922|NCT01967342|182848018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.548|STANDARD_ERROR_OF_MEAN|0.237||0.021|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.||||.021
91487923|NCT01967342|182848018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.999|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
91487924|NCT01967342|182848018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.243||0.305|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.||||.305
91487925|NCT01967342|182848019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.086|STANDARD_ERROR_OF_MEAN|0.623||0.082|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.||||.082
91487926|NCT01967342|182848019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.532||0.652|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.||||.652
91487927|NCT01967342|182848019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.416|STANDARD_ERROR_OF_MEAN|0.612|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||< .001
91487928|NCT01967342|182848019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.619|STANDARD_ERROR_OF_MEAN|0.528||0.241|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.||||.241
91487929|NCT01967342|182848019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.251|STANDARD_ERROR_OF_MEAN|0.617|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
91487930|NCT01967342|182848019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.434|STANDARD_ERROR_OF_MEAN|0.541||0.422|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.||||.422
91487931|NCT01967342|182848020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).||||<.001
91487932|NCT01967342|182848020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).||||.001
91686843|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|3.76||0.2075|TWO_SIDED|90.0|-1.47|11.01||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||11.01|-1.47|0.2075
91487933|NCT01967342|182848020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.217|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).||||.217
91487934|NCT01967342|182848020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.009|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.009
91487935|NCT01967342|182848020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.32||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.001
91487936|NCT01967342|182848020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.389|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.389
91487937|NCT00395733|182848039|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9736||||||90.0|0.9315|1.0168|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0168|0.9315|
91487938|NCT00395733|182848039|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.954||||||90.0|0.9122|0.9965|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9965|0.9122|
91686844|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|3.77||0.2484|TWO_SIDED|90.0|-1.88|10.64||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||10.64|-1.88|0.2484
91720260|NCT01140906|183333468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-9.53|-3.31||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.31|-9.53|<0.0001
91720261|NCT01140906|183333468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-11.73|-5.69||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-5.69|-11.73|<0.0001
91720262|NCT01140906|183333469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32||||0.0016|TWO_SIDED|95.0|1.37|3.91||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||3.91|1.37|0.0016
91489400|NCT02484690|182851578|SUPERIORITY||Difference in Least Squares Means|-14.4||||0.2089|TWO_SIDED|80.0|-29.1|0.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||0.29|-29.1|0.2089
91686845|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.61||0.3399|TWO_SIDED|90.0|-2.53|9.45||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.45|-2.53|0.3399
91720263|NCT01140906|183333469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.0002|TWO_SIDED|95.0|1.58|4.44||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.44|1.58|0.0002
91720264|NCT01140906|183333469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.99|8.37||Wald's test. This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted for Odds Ratio|||||8.37|2.99|<0.0001
91720265|NCT01140906|183333470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|1.16||0.0054|TWO_SIDED|95.0|-5.51|-0.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.97|-5.51|0.0054
91720266|NCT01140906|183333470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.11||0.0005|TWO_SIDED|95.0|-6.11|-1.73||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.73|-6.11|0.0005
91720267|NCT01140906|183333470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-9.16|-4.7||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-4.70|-9.16|<0.0001
91720268|NCT01140906|183333471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.59||0.2524|TWO_SIDED|95.0|-1.83|0.48||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.48|-1.83|0.2524
91487939|NCT00395733|182848039|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9458||||||90.0|0.8776|1.024|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0240|0.8776|
91527659|NCT01976364|182930488|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.91|2.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.31|-0.91|
91720269|NCT01140906|183333471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.4186|TWO_SIDED|95.0|-1.64|0.68||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.68|-1.64|0.4186
91720270|NCT01140906|183333472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.7372|TWO_SIDED|95.0|-0.95|0.67||A nominal p-value is provided.|ANCOVA|||||0.67|-0.95|0.7372
91720271|NCT01140906|183333472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.41||0.169|TWO_SIDED|95.0|-0.24|1.37||A nominal p-value is provided.|ANCOVA|||||1.37|-0.24|0.1690
91720272|NCT01649765|183333473|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.64|3.46||||||||3.46|0.64|
91720273|NCT01649765|183333474|SUPERIORITY||Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|1.15|6.54|||||Definition 1|||6.54|1.15|
91720274|NCT01649765|183333474|SUPERIORITY||Odds Ratio (OR)|2.92|||||TWO_SIDED|95.0|1.19|7.17|||||Definition 2|||7.17|1.19|
91720275|NCT02469233|183333485|SUPERIORITY||Time by treatment interaction coeff.|-3.18||||0.025|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.025
91720276|NCT02469233|183333485|SUPERIORITY||Time by treatment interaction coeff.|-1.52||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.28
91720277|NCT02469233|183333486|SUPERIORITY||time by treatment interaction coeff.|-5.88||||0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.001
91720278|NCT02469233|183333486|SUPERIORITY||maximum likelihood estimation|-3.9||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.03
91720279|NCT02469233|183333487|SUPERIORITY||time by treatment interaction coeff.|-5.55|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
91720280|NCT02469233|183333487|SUPERIORITY||Time by treatment interaction coeff.|-4.92|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||<0.0001
91720281|NCT02469233|183333488|SUPERIORITY||Time by treatment interaction coeff.|-9.14|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
91720282|NCT02469233|183333488|SUPERIORITY||Time by treatment interaction coeff.|-5.37||||0.027|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.027
91720283|NCT02469233|183333489|SUPERIORITY||Time by treatment interaction coeff.|-0.95||||0.32|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.32
91720284|NCT02469233|183333489|SUPERIORITY||Time by treatment interaction coeff.|-1.67||||0.08|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.08
91686846|NCT04856917|183265924|SUPERIORITY||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|3.62||0.0545|TWO_SIDED|90.0|1.03|13.05||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||13.05|1.03|0.0545
91720285|NCT02469233|183333490|SUPERIORITY||Time by treatment interaction coeff.|-0.09||||0.72|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.72
91720286|NCT02469233|183333490|SUPERIORITY||Time by treatment interaction coeff.|-0.08||||0.74|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.74
91720287|NCT02469233|183333491|SUPERIORITY||Time by treatment interaction coeff.|-2.46||||0.73|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.73
91720288|NCT02469233|183333491|SUPERIORITY||Time by treatment interaction coeff.|-17.52||||0.02|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.02
91720289|NCT02469233|183333492|SUPERIORITY||Time by treatment interaction coeff.|5.68||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.03
91720290|NCT02469233|183333492|SUPERIORITY||Time by treatment interaction coeff.|5.89||||0.03|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.03
91489401|NCT02484690|182851581|SUPERIORITY||Difference in Least Squares Means|-0.4||||0.6717|TWO_SIDED|80.0|-1.61|0.81||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.81|-1.61|0.6717
91720291|NCT02469233|183333492|SUPERIORITY||Time by treatment interaction coeff.|-1.45||||0.43|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.43
91720292|NCT02469233|183333492|SUPERIORITY||Time by treatment interaction coeff.|-1.55||||0.4|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.40
91720293|NCT02469233|183333493|SUPERIORITY||Time by treatment interaction coeff.|-12.68||||0.59|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.59
91720294|NCT02469233|183333493|SUPERIORITY||Time by treatment interaction coeff.|-28.33||||0.22|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.22
91720295|NCT02469233|183333493|SUPERIORITY||Time by treatment interaction coeff.|4.65||||0.8|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.80
91487940|NCT00395733|182848039|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.8698||||||90.0|0.78|0.9657|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9657|0.7800|
91686847|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|11.69||0.9679|TWO_SIDED|90.0|-19.86|18.91||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||18.91|-19.86|0.9679
91487941|NCT04981392|182848049|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0066|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0066
91487942|NCT04981392|182848050|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.3||0.0058|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0058
91487943|NCT04856891|182848051|SUPERIORITY||Percent Difference from Placebo|78.4|||<|0.0001|TWO_SIDED|95.0|62.2|89.1|||Fisher Exact|||||89.1|62.2|<0.0001
91487944|NCT04856891|182848052|SUPERIORITY||LSM Difference from Placebo|0.3||||0.8822|TWO_SIDED|95.0|-4.0|4.7|||Mixed Models Analysis|||||4.7|-4.0|0.8822
91686848|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|11.83||0.9152|TWO_SIDED|90.0|-20.87|18.35||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||18.35|-20.87|0.9152
91686849|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|9.64||0.449|TWO_SIDED|90.0|-8.67|23.32||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||23.32|-8.67|0.4490
91686850|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|9.74||0.7246|TWO_SIDED|90.0|-12.72|19.6||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.60|-12.72|0.7246
91686851|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|13.8|STANDARD_ERROR_OF_MEAN|18.88||0.4655|TWO_SIDED|90.0|-17.49|45.14||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||45.14|-17.49|0.4655
91686852|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|19.33||0.1178|TWO_SIDED|90.0|-1.59|62.54||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||62.54|-1.59|0.1178
91686853|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|17.71||0.1938|TWO_SIDED|90.0|-6.22|52.52||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||52.52|-6.22|0.1938
91686854|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|29.7|STANDARD_ERROR_OF_MEAN|17.85||0.0991|TWO_SIDED|90.0|0.08|59.29||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||59.29|0.08|0.0991
91686855|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|15.0|STANDARD_ERROR_OF_MEAN|15.44||0.3337|TWO_SIDED|90.0|-10.62|40.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||40.59|-10.62|0.3337
91686856|NCT04856917|183265925|SUPERIORITY||LS Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|15.48||0.0465|TWO_SIDED|90.0|5.5|56.87||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||56.87|5.50|0.0465
91686857|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.95||0.215|TWO_SIDED|90.0|-1.21|8.56||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||8.56|-1.21|0.2150
91720296|NCT02469233|183333493|SUPERIORITY||Time by treatment interaction coeff.|-7.57||||0.68|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.68
91720297|NCT02469233|183333494|SUPERIORITY||Time by treatment interaction coeff.|-76.85||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.34
91720298|NCT02469233|183333494|SUPERIORITY||Time by treatment interaction coeff.|-87.15||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.28
91720299|NCT02469233|183333494|SUPERIORITY||Time by treatment interaction coeff.|-0.15||||0.18|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.18
91487945|NCT04856891|182848053|SUPERIORITY||LSM Difference from Placebo|-74.9|||<|0.0001|TWO_SIDED|95.0|-85.2|-64.7|||ANCOVA|||||-64.7|-85.2|<0.0001
91686858|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.97||0.0864|TWO_SIDED|90.0|0.21|10.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||10.05|0.21|0.0864
91686859|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|3.88||0.0084|TWO_SIDED|90.0|3.97|16.85||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||16.85|3.97|0.0084
91720300|NCT02469233|183333494|SUPERIORITY||Time by treatment interaction coeff.|-0.27||||0.02|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.02
91720301|NCT02469233|183333495|SUPERIORITY||Time by treatment interaction coeff.|-7.19||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.09
91720302|NCT02469233|183333495|SUPERIORITY||Time by treatment interaction coeff.|-1.13||||0.79|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome.||Treatment effect on change from pre to 6-month follow-up||||0.79
91720303|NCT02469233|183333496|SUPERIORITY||Time by treatment interaction coeff.|0.16||||0.46|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome,||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.46
91720304|NCT02469233|183333496|SUPERIORITY||Time by treatment interaction coeff.|-0.34||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.10
91720305|NCT02469233|183333497|SUPERIORITY||Time by treatment interaction coeff.|0.91||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.002
91720306|NCT02469233|183333497|SUPERIORITY||Time by treatment interaction coeff.|0.64||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up.||||0.03
91720307|NCT02469233|183333498|SUPERIORITY||Time by treatment interaction coeff.|24.85||||0.23|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.23
91720308|NCT02469233|183333498|SUPERIORITY||Time by treatment interaction coeff.|34.31||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.09
91487946|NCT04856891|182848054|SUPERIORITY||Percent Difference from Placebo|80.4|||<|0.0001|TWO_SIDED|95.0|64.8|90.6|||Fisher Exact|||||90.6|64.8|<0.0001
91686860|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.91||0.16|TWO_SIDED|90.0|-0.95|12.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||12.01|-0.95|0.1600
91487947|NCT04856891|182848055|SUPERIORITY||Percent Difference from Placebo|43.5|||<|0.0001|TWO_SIDED|95.0|23.5|59.9|||Fisher Exact|||||59.9|23.5|<0.0001
91487948|NCT04856891|182848056|SUPERIORITY||Percent Difference from Placebo|-1.5||||1|TWO_SIDED|95.0|-22.2|18.0|||Fisher Exact|||||18.0|-22.2|1.0000
91720309|NCT02469233|183333498|SUPERIORITY||Time by treatment interaction coeff.|-19.9||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.19
91720310|NCT02469233|183333498|SUPERIORITY||Time by treatment interaction coeff.|-1.76||||0.91|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.91
91720311|NCT02469233|183333499|SUPERIORITY||Time by treatment interaction coeff.|-39.33||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.04
91720312|NCT02469233|183333499|SUPERIORITY||Time by treatment interaction coeff.|-28.56||||0.13|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.13
91720313|NCT02469233|183333499|SUPERIORITY||Time by treatment interaction coeff.|-17.57||||0.21|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.21
91720314|NCT02469233|183333499|SUPERIORITY||Time by treatment interaction coeff.|-16.05||||0.25|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.25
91720315|NCT02469233|183333500|SUPERIORITY||Time by treatment interaction coeff.|-0.55||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.10
91720316|NCT02469233|183333500|SUPERIORITY||Time by treatment interaction coeff.|-0.71||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT mean: Treatment effect on change from pre to 6-month follow-up.||||0.04
91720317|NCT02469233|183333500|SUPERIORITY||Time by treatment interaction coeff.|-0.31||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.20
91720318|NCT02469233|183333500|SUPERIORITY||Time by treatment interaction coeff.|-0.45||||0.07|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to 6-month follow-up.||||0.07
91720319|NCT02469233|183333501|SUPERIORITY||Time by treatment interaction coeff.|-0.33||||0.39|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.39
91720320|NCT02469233|183333501|SUPERIORITY||Time by treatment interaction coeff.|-0.02||||0.96|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to 6-month follow-up.||||0.96
91720321|NCT02469233|183333501|SUPERIORITY||Time by treatment interaction coeff.|-0.39||||0.047|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.047
91720322|NCT02469233|183333501|SUPERIORITY||Time by treatment interaction coeff.|0.2||||0.3|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to 6-month follow-up.||||0.30
91720323|NCT02469233|183333502|SUPERIORITY||Time by treatment interaction coeff.|-4.42||||0.66|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.66
91720324|NCT02469233|183333502|SUPERIORITY||Time by treatment interaction coeff.|-13.34||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.19
91720325|NCT02469233|183333502|SUPERIORITY||Time by treatment interaction coeff.|-0.05||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.77
91720326|NCT02469233|183333502|SUPERIORITY||Time by treatment interaction coeff.|-0.22||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.20
91487949|NCT04856891|182848057|SUPERIORITY||Percent Difference from Placebo|6.9||||0.4502|TWO_SIDED|95.0|-13.8|26.3|||Fisher Exact|||||26.3|-13.8|0.4502
91487950|NCT04856891|182848058|SUPERIORITY||LSM Difference from Placebo|-3.1||||0.6805|TWO_SIDED|95.0|-18.1|11.8|||Mixed Models Analysis|||Weeks 24 Percent Change from Baseline||11.8|-18.1|0.6805
91487951|NCT01697358|182848067|SUPERIORITY|||||||0.036|||||||Z-test using unpooled standard deviation|||||||0.036
91686861|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.23||0.3671|TWO_SIDED|90.0|-3.94|13.41||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||13.41|-3.94|0.3671
91487952|NCT01697358|182848068|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
91686862|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.35||0.1587|TWO_SIDED|90.0|-1.28|16.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||16.46|-1.28|0.1587
91686863|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.8||0.1932|TWO_SIDED|90.0|-2.03|17.21||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||17.21|-2.03|0.1932
91686864|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.82||0.2518|TWO_SIDED|90.0|-2.95|16.37||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||16.37|-2.95|0.2518
91686865|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.53||0.232|TWO_SIDED|90.0|-2.53|15.83||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||15.83|-2.53|0.2320
91686866|NCT04856917|183265926|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.55||0.2014|TWO_SIDED|90.0|-2.08|16.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||16.35|-2.08|0.2014
91720327|NCT00855582|183333554|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.58|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91487953|NCT01697358|182848069|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
91487954|NCT01697358|182848070|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.||||||< 0.001
91487955|NCT01697358|182848071|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.||||||< 0.001
91487956|NCT01697358|182848072|SUPERIORITY||||||<|0.001|||||||Z-test using unpooled standard deviation|||||||< 0.001
91487957|NCT02387710|182848073|OTHER||||||>|0.5|||||||Wilcoxon (Mann-Whitney)|||||||>0.5
91487958|NCT02155881|182848096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9716|TWO_SIDED|95.0|-0.98|1.01|||ANCOVA|||An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.01|-0.98|0.9716
91487959|NCT02155881|182848097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.8713|TWO_SIDED|95.0|-0.87|1.02|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.02|-0.87|0.8713
91487960|NCT02155881|182848098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.7789|TWO_SIDED|95.0|-0.61|0.81|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.81|-0.61|0.7789
91487961|NCT02155881|182848099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.663|TWO_SIDED|95.0|-0.55|0.86|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.86|-0.55|0.6630
91487962|NCT02155881|182848100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.5593|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.19|-0.35|0.5593
91487963|NCT02155881|182848100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7085|TWO_SIDED|95.0|-0.22|0.33|||ANCOVA|||Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.22|0.7085
91487964|NCT02155881|182848100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7309|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.22|0.7309
91686867|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|4.94||0.4361|TWO_SIDED|90.0|-4.34|12.06||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||12.06|-4.34|0.4361
91487965|NCT02155881|182848100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9584|TWO_SIDED|95.0|-0.29|0.3|||ANCOVA|||Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.30|-0.29|0.9584
91527057|NCT01555164|182929445|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.11||||0.306|TWO_SIDED|95.0|-0.31|0.1||P-value from a mixed-effect model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.4% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||0.10|-0.31|0.306
91686868|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|8.2|STANDARD_ERROR_OF_MEAN|4.98||0.1018|TWO_SIDED|90.0|-0.04|16.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||16.48|-0.04|0.1018
91686869|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|16.3|STANDARD_ERROR_OF_MEAN|5.79||0.0059|TWO_SIDED|90.0|6.66|25.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||25.88|6.66|0.0059
91686870|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|5.83||0.0913|TWO_SIDED|90.0|0.26|19.59||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.59|0.26|0.0913
91686871|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.4921|TWO_SIDED|90.0|-7.47|18.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||18.09|-7.47|0.4921
91686872|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|7.89||0.1607|TWO_SIDED|90.0|-1.95|24.24||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||24.24|-1.95|0.1607
91686873|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|9.19||0.1244|TWO_SIDED|90.0|-1.02|29.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||29.48|-1.02|0.1244
91686874|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|15.2|STANDARD_ERROR_OF_MEAN|9.2||0.1004|TWO_SIDED|90.0|-0.02|30.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||30.51|-0.02|0.1004
91686875|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|9.64||0.2015|TWO_SIDED|90.0|-3.61|28.39||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||28.39|-3.61|0.2015
91686876|NCT04856917|183265927|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|9.66||0.1057|TWO_SIDED|90.0|-0.27|31.81||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||31.81|-0.27|0.1057
91487966|NCT02155881|182848101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.2266|TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|||Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.46|-0.11|0.2266
91487967|NCT02155881|182848101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.4888|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.17|-0.35|0.4888
91527058|NCT00697190|182929448|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|97.5|-0.29|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.04|-0.29|
91487968|NCT02155881|182848101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8316|TWO_SIDED|95.0|-0.22|0.27|||ANCOVA|||Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.27|-0.22|0.8316
91487969|NCT02155881|182848102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2968|TWO_SIDED|95.0|-0.8|0.25|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.25|-0.80|0.2968
91487970|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.3533|TWO_SIDED|95.0|-0.85|0.31|||ANCOVA|||Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.85|0.3533
91487971|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.3712|TWO_SIDED|95.0|-0.84|0.32|||ANCOVA|||Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.32|-0.84|0.3712
91686877|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.5157|TWO_SIDED|90.0|-0.08|0.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||0.19|-0.08|0.5157
91686878|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0178|TWO_SIDED|90.0|0.06|0.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||0.34|0.06|0.0178
91686879|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.3|STANDARD_DEVIATION|0.12||0.0132|TWO_SIDED|90.0|0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||0.48|0.10|0.0132
91686880|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0034|TWO_SIDED|90.0|0.16|0.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||0.54|0.16|0.0034
91686881|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.051|TWO_SIDED|90.0|0.04|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||0.47|0.04|0.0510
91686882|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0608|TWO_SIDED|90.0|0.03|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||0.47|0.03|0.0608
91686883|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2702|TWO_SIDED|90.0|-0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||0.48|-0.10|0.2702
91686884|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0249|TWO_SIDED|90.0|0.11|0.69||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||0.69|0.11|0.0249
91487972|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4098|TWO_SIDED|95.0|-0.69|0.29|||ANCOVA|||Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.29|-0.69|0.4098
91487973|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.2683|TWO_SIDED|95.0|-1.0|0.28|||ANCOVA|||Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.28|-1.00|0.2683
91487974|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4643|TWO_SIDED|95.0|-0.82|0.38|||ANCOVA|||Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.38|-0.82|0.4643
91487975|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4502|TWO_SIDED|95.0|-0.74|0.33|||ANCOVA|||Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.74|0.4502
91527059|NCT00697190|182929449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|97.5|-0.1|0.06|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.06|-0.10|
91527060|NCT00697190|182929450|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.23|0.1|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.10|-0.23|
91686885|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1853|TWO_SIDED|90.0|-0.06|0.55||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||0.55|-0.06|0.1853
91487976|NCT02155881|182848103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.177|TWO_SIDED|95.0|-0.95|0.18|||ANCOVA|||Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.18|-0.95|0.1770
91686886|NCT04856917|183265928|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2974|TWO_SIDED|90.0|-0.11|0.5||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||0.50|-0.11|0.2974
91686887|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-2.5||||0.339|TWO_SIDED|90.0|-6.62|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.63|-6.62|0.3390
91720328|NCT00855582|183333555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.66|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720329|NCT00855582|183333556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.181||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.181
91686888|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-2.6||||0.3243|TWO_SIDED|90.0|-6.79|1.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.59|-6.79|0.3243
91686889|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-5.91|5.91||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 8||5.91|-5.91|1.0000
91686890|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-2.66||||0.332|TWO_SIDED|90.0|-6.96|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 8||1.63|-6.96|0.3320
91686891|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-2.45||||0.7595|TWO_SIDED|90.0|-15.5|10.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 12||10.59|-15.50|0.7595
91686892|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-14.11||||0.0209|TWO_SIDED|90.0|-23.66|-4.57||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 12||-4.57|-23.66|0.0209
91720330|NCT00855582|183333557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.67|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91487977|NCT03841448|182848138|SUPERIORITY||Placebo-adjusted GM Percent Change|-37.367||||0.1032|TWO_SIDED|90.0|-60.951|0.46|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||0.460|-60.951|0.1032
91720331|NCT00855582|183333558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91487978|NCT03841448|182848139|SUPERIORITY||Placebo-adjusted GM Percent Change|-36.167||||0.1432|TWO_SIDED|90.0|-61.552|5.978|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||5.978|-61.552|0.1432
91686893|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-4.56||||0.6094|TWO_SIDED|90.0|-18.99|9.87||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.87|-18.99|0.6094
91487979|NCT03841448|182848140|SUPERIORITY||Odds Ratio (OR)|3.01||||0.1177|TWO_SIDED|90.0|0.43|21.27|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||21.27|0.43|0.1177
91487980|NCT03841448|182848140|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
91487981|NCT03841448|182848141|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1533|TWO_SIDED|90.0|0.45|20.34|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||20.34|0.45|0.1533
91487982|NCT03841448|182848141|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
91487983|NCT03841448|182848142|SUPERIORITY||Placebo-adjusted GM Percent Change|-45.771||||0.0021|TWO_SIDED|90.0|-60.093|-26.309|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS means difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||-26.309|-60.093|0.0021
91527061|NCT00697190|182929451|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.25|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.04|-0.25|
91686894|NCT04856917|183265929|SUPERIORITY||Risk Difference (RD)|-10.28||||0.2076|TWO_SIDED|90.0|-23.34|2.78||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.78|-23.34|0.2076
91686895|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|0.1||||0.4482|TWO_SIDED|90.0|-0.1|0.29||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.29|-0.10|0.4482
91686896|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|0.14||||0.4529|TWO_SIDED|90.0|-0.05|0.33||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.33|-0.05|0.4529
91686897|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.01||||0.932|TWO_SIDED|90.0|-0.2|0.18||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.18|-0.20|0.9320
91720332|NCT00855582|183333559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91487984|NCT04068610|182848149|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3173|TWO_SIDED|95.0|0.6|5.6|||Cochran-Mantel-Haenszel|P-value for comparison of treatment arms obtained from stratified Cochran-Mantel-Haenszel test stratified by the location of the primary tumor.||||5.6|0.6|0.3173
91487985|NCT02586064|182848174|OTHER|||||||0.28|||||||t-test, 1 sided|||Baseline||||0.28
91487986|NCT02586064|182848174|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|||||||||||||
91487987|NCT02586064|182848174|OTHER|||||||0.87|||||||t-test, 1 sided|||End of Treatment||||0.87
91487988|NCT02586064|182848174|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|||||||||||||
91487989|NCT02586064|182848174|EQUIVALENCE|Equivalence hypothesis was assessed using the confidence intervals for the mean differences compared to margins of equivalence (-7,7). The equivalence hypothesis was examined based on the difference between the amount of change from the baseline to the end of treatment on the CAPS between the two conditions. Confidence interval is -7.0 to 1.9.||||||0.26|||||||t-test, 2 sided|||Change||||0.26
91487990|NCT02586064|182848174|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|||||||||||||
91487991|NCT02586064|182848174|OTHER|||||||0.68|||||||t-test, 1 sided|||3 Month Post Treatment||||0.68
91487992|NCT02586064|182848174|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|||||||||||||
91487993|NCT02586064|182848174|OTHER|||||||0.84|||||||t-test, 1 sided|||6 Month Follow Up||||0.84
91487994|NCT02586064|182848174|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|||||||||||||
91487995|NCT02586064|182848175|OTHER|||||||0.36|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Baseline||||0.36
91487996|NCT02586064|182848175|OTHER|||||||0.34|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||4-Week||||0.34
91487997|NCT02586064|182848175|OTHER|||||||0.43|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||8-Week||||0.43
91487998|NCT02586064|182848175|OTHER|||||||0.09|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||6 Month Post Treatment||||0.09
91686898|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.03||||0.3151|TWO_SIDED|90.0|-0.22|0.16||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 4||0.16|-0.22|0.3151
91487999|NCT02586064|182848175|OTHER|||||||0.41|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||End of Treatment||||0.41
91720333|NCT00855582|183333560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.85|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720334|NCT00855582|183333561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.156||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.156
91720335|NCT00855582|183333562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.226||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.226
91720336|NCT00855582|183333562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91488000|NCT02586064|182848175|SUPERIORITY|Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05).||||||0.64|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Change||||0.64
91686899|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.14||||0.2908|TWO_SIDED|90.0|-0.32|0.06||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.06|-0.32|0.2908
91686900|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|0.05||||0.7277|TWO_SIDED|90.0|-0.15|0.24||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||0.24|-0.15|0.7277
91686901|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.03||||0.8463|TWO_SIDED|90.0|-0.23|0.17||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.17|-0.23|0.8463
91686902|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.08||||0.5281|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||0.11|-0.28|0.5281
91686903|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.09||||0.5747|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.11|-0.28|0.5747
91686904|NCT04856917|183265930|SUPERIORITY||Risk Difference (RD)|-0.05||||0.5081|TWO_SIDED|90.0|-0.24|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.14|-0.24|0.5081
91686905|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|0.01||||0.8338|TWO_SIDED|90.0|-0.19|0.2||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.20|-0.19|0.8338
91686906|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.12||||0.1142|TWO_SIDED|90.0|-0.31|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.09|-0.31|0.1142
91686907|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.2||||0.3433|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.00|-0.38|0.3433
91686908|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.17||||0.1129|TWO_SIDED|90.0|-0.37|0.04||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.04|-0.37|0.1129
91686909|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.2||||0.2842|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.00|-0.38|0.2842
91686910|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.34||||0.0212|TWO_SIDED|90.0|-0.52|-0.13||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||-0.13|-0.52|0.0212
91686911|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.07||||0.7665|TWO_SIDED|90.0|-0.28|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.14|-0.28|0.7665
91720337|NCT00855582|183333563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.121
91720338|NCT00855582|183333563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.57||0.169||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.169
91720339|NCT00855582|183333563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.52|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720340|NCT00855582|183333563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.56|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720341|NCT00855582|183333564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720342|NCT00855582|183333564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720343|NCT00855582|183333564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.59|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91488001|NCT02586064|182848175|OTHER|||||||0.22|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||3 Month Post Treatment||||0.22
91720344|NCT00855582|183333564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720345|NCT00855582|183333565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91527062|NCT00697190|182929452|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.16|0.07|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.07|-0.16|
91720346|NCT00855582|183333565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91488002|NCT02586064|182848176|OTHER|||||||0.4|||||||t-test, 1 sided|||Baseline||||0.40
91488003|NCT02586064|182848176|OTHER|||||||0.65|||||||t-test, 1 sided|||End of Treatment||||0.65
91488004|NCT02586064|182848176|OTHER|||||||0.64|||||||t-test, 1 sided|||Change||||0.64
91488005|NCT02586064|182848176|OTHER|||||||0.64|||||||t-test, 1 sided|||3 Month Post Treatment||||0.64
91488006|NCT02586064|182848176|OTHER|||||||0.76|||||||t-test, 1 sided|||6 Month Post Treatment||||0.76
91488007|NCT02586064|182848177|OTHER|||||||0.11|||||||t-test, 1 sided|||Baseline||||0.11
91488008|NCT02586064|182848177|OTHER|||||||0.48|||||||t-test, 1 sided|||4-Week||||0.48
91488009|NCT02586064|182848177|OTHER|||||||0.74|||||||t-test, 1 sided|||8-Week||||0.74
91488010|NCT02586064|182848177|OTHER|||||||0.34|||||||t-test, 1 sided|||End of Treatment||||0.34
91488011|NCT02586064|182848177|OTHER|||||||0.65|||||||t-test, 1 sided|||Change||||0.65
91488012|NCT02586064|182848177|OTHER|||||||0.14|||||||t-test, 1 sided|||3 Month Post Treatment||||0.14
91488013|NCT02586064|182848177|OTHER|||||||0.18|||||||t-test, 1 sided|||6 Month Post Treatment||||0.18
91488014|NCT02586064|182848178|OTHER|||||||0.08|||||||t-test, 1 sided|||Baseline||||0.08
91527063|NCT00697190|182929453|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.25|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.14|-0.25|
91720347|NCT00855582|183333565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91488015|NCT02586064|182848178|OTHER|||||||0.07|||||||t-test, 1 sided|||End of Treatment||||0.07
91686912|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.22||||0.1777|TWO_SIDED|90.0|-0.42|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||-0.00|-0.42|0.1777
91686913|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.12||||0.3741|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.09|-0.33|0.3741
91686914|NCT04856917|183265931|SUPERIORITY||Risk Difference (RD)|-0.13||||0.3321|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.09|-0.33|0.3321
91686915|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.7932|TWO_SIDED|90.0|-1.56|2.14||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.14|-1.56|0.7932
91686916|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.12||0.4365|TWO_SIDED|90.0|-0.99|2.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||2.73|-0.99|0.4365
91686917|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8543|TWO_SIDED|90.0|-1.92|1.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.54|-1.92|0.8543
91686918|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.8726|TWO_SIDED|90.0|-1.91|1.58||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.58|-1.91|0.8726
91686919|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07||0.5983|TWO_SIDED|90.0|-1.22|2.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.35|-1.22|0.5983
91686920|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.09||0.3396|TWO_SIDED|90.0|-0.77|2.86||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||2.86|-0.77|0.3396
91488016|NCT02586064|182848178|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
91488017|NCT02586064|182848178|OTHER|||||||0.003|||||||t-test, 1 sided|||3 Month Post Treatment||||0.003
91488018|NCT02586064|182848178|OTHER|||||||0.03|||||||t-test, 1 sided|||6 Month Post Treatment||||0.03
91488019|NCT02586064|182848179|OTHER|||||||0.05|||||||t-test, 1 sided|||Baseline||||0.05
91488020|NCT02586064|182848179|OTHER|||||||0.04|||||||t-test, 1 sided|||End of Treatment||||0.04
91488021|NCT02586064|182848179|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
91686921|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.97||0.5305|TWO_SIDED|90.0|-2.23|1.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||1.01|-2.23|0.5305
91488022|NCT02586064|182848179|OTHER||||||<|0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||<0.001
91488023|NCT02586064|182848179|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
91488024|NCT02586064|182848180|OTHER|||||||0.45|||||||t-test, 1 sided|||Baseline||||0.45
91488025|NCT02586064|182848180|OTHER|||||||0.71|||||||t-test, 1 sided|||End of Treatment||||0.71
91488026|NCT02586064|182848180|OTHER|||||||0.6|||||||t-test, 1 sided|||Change||||0.60
91488027|NCT02586064|182848180|OTHER|||||||0.13|||||||t-test, 1 sided|||3 Month Post Treatment||||0.13
91488028|NCT02586064|182848180|OTHER|||||||0.8|||||||t-test, 1 sided|||6 Month Post Treatment||||0.80
91488029|NCT02586064|182848181|OTHER|||||||0.35|||||||t-test, 1 sided|||Baseline||||0.35
91488030|NCT02586064|182848181|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
91720348|NCT00855582|183333565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720349|NCT00855582|183333566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.215||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.215
91720350|NCT00855582|183333566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.325||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.325
91720351|NCT00855582|183333566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720352|NCT00855582|183333566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.011||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.011
91686922|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0819|TWO_SIDED|90.0|0.09|3.29||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||3.29|0.09|0.0819
91720353|NCT00855582|183333567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.23||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.230
91720354|NCT00855582|183333567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.37|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720355|NCT00855582|183333568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.191||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.191
91720356|NCT00855582|183333568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720357|NCT00855582|183333569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.763||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.763
91720358|NCT00855582|183333569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.075||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.075
91488031|NCT02586064|182848181|OTHER|||||||0.74|||||||t-test, 1 sided|||Change||||0.74
91488032|NCT02586064|182848181|OTHER|||||||0.03|||||||t-test, 1 sided|||3 Month Post Treatment||||0.03
91488033|NCT02586064|182848181|OTHER|||||||0.22|||||||t-test, 1 sided|||6 Month Post Treatment||||0.22
91527064|NCT00697190|182929454|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|0.04|0.32|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.32|0.04|
91686923|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.09||0.0243|TWO_SIDED|90.0|0.69|4.31||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||4.31|0.69|0.0243
91686924|NCT04856917|183265932|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.05||0.1061|TWO_SIDED|90.0|-0.03|3.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||3.46|-0.03|0.1061
91686925|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.67||0.9333|TWO_SIDED|90.0|-2.69|2.97||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.97|-2.69|0.9333
91686926|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.3972|TWO_SIDED|90.0|-1.4|4.27||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||4.27|-1.40|0.3972
91686927|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.11||0.0662|TWO_SIDED|90.0|0.23|3.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||3.99|0.23|0.0662
91686928|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.8898|TWO_SIDED|90.0|-1.73|2.04||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||2.04|-1.73|0.8898
91686929|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.06||0.3664|TWO_SIDED|90.0|-0.85|2.82||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.82|-0.85|0.3664
91686930|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0655|TWO_SIDED|90.0|0.25|4.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||4.05|0.25|0.0655
91686931|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.6921|TWO_SIDED|90.0|-1.61|2.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||2.57|-1.61|0.6921
91686932|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0406|TWO_SIDED|90.0|0.59|4.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||4.88|0.59|0.0406
91686933|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6872|TWO_SIDED|90.0|-2.24|1.38||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||1.38|-2.24|0.6872
91686934|NCT04856917|183265933|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.08||0.3392|TWO_SIDED|90.0|-0.81|2.92||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.92|-0.81|0.3392
91686935|NCT00486525|183265985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|STANDARD_ERROR_OF_MEAN|0.058||0.2|TWO_SIDED|95.0|-0.19|0.039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.039|-0.19|0.20
91686936|NCT00486525|183265985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.027|TWO_SIDED|95.0|-0.25|-0.015|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.015|-0.25|0.027
91686937|NCT00486525|183265985|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.28|TWO_SIDED|95.0|-0.06|0.018|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.018|-0.060|0.28
91686938|NCT00486525|183265985|SUPERIORITY_OR_OTHER||Slope|-0.038|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.079|0.0021|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0021|-0.079|0.063
91720359|NCT00855582|183333570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.384||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.384
91720360|NCT00855582|183333570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.082||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.082
91488034|NCT02586064|182848182|OTHER|||||||0.39|||||||t-test, 1 sided|||Baseline||||0.39
91488035|NCT02586064|182848182|OTHER|||||||0.15|||||||t-test, 1 sided|||End of Treatment||||0.15
91488036|NCT02586064|182848182|OTHER|||||||0.72|||||||t-test, 1 sided|||Change||||0.72
91686939|NCT00486525|183265986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.062||0.2|TWO_SIDED|95.0|-0.2|-0.042|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.042|-0.2|0.2
91720361|NCT00855582|183333571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91686940|NCT00486525|183265986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.064||0.015|TWO_SIDED|95.0|-0.28|-0.031|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.031|-0.28|0.015
91686941|NCT00486525|183265986|SUPERIORITY_OR_OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.021||0.3|TWO_SIDED|95.0|-0.063|0.019|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.019|-0.063|0.3
91686942|NCT00486525|183265986|SUPERIORITY_OR_OTHER||Slope|-0.056|STANDARD_ERROR_OF_MEAN|0.022||0.01|TWO_SIDED|95.0|-0.098|-0.013|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.013|-0.098|0.01
91686943|NCT00486525|183265987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.33|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.11|-0.31|0.33
91720362|NCT00855582|183333571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720363|NCT00855582|183333572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91488037|NCT02586064|182848182|OTHER|||||||0.04|||||||t-test, 1 sided|||3 Month Post Treatment||||0.04
91488038|NCT02586064|182848182|OTHER|||||||0.19|||||||t-test, 1 sided|||6 Month Post Treatment||||0.19
91488039|NCT02586064|182848183|OTHER|||||||0.33|||||||t-test, 1 sided|||Baseline||||0.33
91488040|NCT02586064|182848183|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
91488041|NCT02586064|182848183|OTHER|||||||0.88|||||||t-test, 1 sided|||Change||||0.88
91488042|NCT02586064|182848183|OTHER|||||||0.06|||||||t-test, 1 sided|||3 Month Post Treatment||||0.06
91488043|NCT02586064|182848183|OTHER|||||||0.56|||||||t-test, 1 sided|||6 Month Post Treatment||||0.56
91488044|NCT02586064|182848184|OTHER|||||||0.16|||||||t-test, 1 sided|||Baseline||||0.16
91488045|NCT02586064|182848184|OTHER|||||||0.06|||||||t-test, 1 sided|||End of Treatment||||0.06
91488046|NCT02586064|182848184|OTHER|||||||0.46|||||||t-test, 1 sided|||Change||||0.46
91488047|NCT02586064|182848184|OTHER|||||||0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||0.001
91527065|NCT00697190|182929455|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.26|0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.08|-0.26|
91488048|NCT02586064|182848184|OTHER|||||||0.002|||||||t-test, 1 sided|||6 Month Post Treatment||||0.002
91488049|NCT02586064|182848185|OTHER|||||||0.24|||||||t-test, 1 sided|||Baseline||||0.24
91488050|NCT02586064|182848185|OTHER|||||||0.81|||||||t-test, 1 sided|||End of Treatment||||0.81
91488051|NCT02586064|182848185|OTHER|||||||0.24|||||||t-test, 1 sided|||Change||||0.24
91488052|NCT02586064|182848186|OTHER|||||||0.41|||||||t-test, 1 sided|||Baseline||||0.41
91488053|NCT02586064|182848186|OTHER|||||||0.21|||||||t-test, 1 sided|||End of Treatment||||0.21
91488054|NCT02586064|182848186|OTHER|||||||0.5|||||||t-test, 1 sided|||Change||||0.50
91488055|NCT02586064|182848187|OTHER|||||||0.7|||||||t-test, 1 sided|||Baseline||||0.70
91488056|NCT02586064|182848187|OTHER|||||||0.96|||||||t-test, 1 sided|||Week 4||||0.96
91488057|NCT02586064|182848187|OTHER|||||||0.59|||||||t-test, 1 sided|||Week 8||||0.59
91720364|NCT00855582|183333572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720365|NCT00855582|183333573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91488058|NCT02586064|182848187|OTHER|||||||0.61|||||||t-test, 1 sided|||End of Treatment||||0.61
91720366|NCT00855582|183333573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720367|NCT00855582|183333574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720368|NCT00855582|183333574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91527066|NCT00697190|182929456|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Median Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.08||||97.5|0.02|0.33|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.33|0.02|
91720369|NCT00855582|183333575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720370|NCT00855582|183333575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720371|NCT00855582|183333576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.9|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720372|NCT00855582|183333576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.7|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720373|NCT00855582|183333577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720374|NCT00855582|183333577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
91720375|NCT00855582|183333578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
91720376|NCT00855582|183333578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
91720377|NCT00855582|183333579|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||0.006
91720378|NCT00855582|183333579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
91488059|NCT02586064|182848187|OTHER|||||||0.84|||||||t-test, 1 sided|||Change||||0.84
91488060|NCT02586064|182848187|OTHER|||||||0.3|||||||t-test, 1 sided|||3 Month Follow Up||||0.30
91488061|NCT02586064|182848187|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
91488062|NCT00309985|182848221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||Log Rank|||The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.||||0.0003
91488063|NCT00309985|182848222|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91488064|NCT00309985|182848223|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91488065|NCT00309985|182848224|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91527067|NCT00697190|182929457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|97.5|-0.27|0.26|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||0.26|-0.27|
91686944|NCT00486525|183265987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.014|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.014|-0.44|0.037
91686945|NCT00486525|183265987|SUPERIORITY_OR_OTHER||Slope|-0.034|STANDARD_ERROR_OF_MEAN|0.0235||0.33|TWO_SIDED|95.0|-0.1|0.035|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.035|-0.10|0.33
91686946|NCT00486525|183265987|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.036||0.03|TWO_SIDED|95.0|-0.15|-0.0074|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.0074|-0.15|0.03
91686947|NCT00486525|183265988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.2||0.058|TWO_SIDED|95.0|-8.5|0.15|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.15|-8.5|0.058
91686948|NCT00486525|183265988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|-11.4|-2.7|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-2.7|-11.4|0.002
91686949|NCT00486525|183265988|SUPERIORITY_OR_OTHER||Slope|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.019|TWO_SIDED|95.0|-3.1|-0.28|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.28|-3.1|0.019
91686950|NCT00486525|183265988|SUPERIORITY_OR_OTHER||Slope|-2.8|STANDARD_ERROR_OF_MEAN|0.71||0.0001|TWO_SIDED|95.0|-4.2|-1.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-1.4|-4.2|0.0001
91686951|NCT00486525|183265989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.4|11.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.4|1.4|0.01
91720379|NCT00855582|183333580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
91488066|NCT00309985|182848225|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91488067|NCT00309985|182848226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0009
91488068|NCT00309985|182848226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.40
91488069|NCT03401489|182848229|SUPERIORITY||Odds Ratio (OR)|0.99||||0.822|TWO_SIDED|95.0|0.36|2.72||Significance threshold was α=0.05, two-sided. No adjustment for multiple comparisons.|Mixed Models Analysis|Generalized linear mixed models were also run for sensitivity analyses, adjusting for baseline SBP, site, and race.|Difference defined as Control minus PACESETTER at 12 months (SBP \<130 mmHg); odds ratio \<1 favors the PACESETTER arm.|Comparison between PACESETTER and control arms at 12 months for proportion of participants with SBP \<130 mmHg using a generalized linear mixed model (GLMM) with logit link. Model included baseline SBP, site, and race as covariates.||2.72|.36|0.822
91686952|NCT00486525|183265989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.5|11.6|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.6|1.5|0.01
91686953|NCT00486525|183265989|SUPERIORITY_OR_OTHER||Slope|2.1|STANDARD_ERROR_OF_MEAN|0.85||0.016|TWO_SIDED|95.0|0.4|3.75|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||3.75|0.40|0.016
91686954|NCT00486525|183265989|SUPERIORITY_OR_OTHER||Slope|2.5|STANDARD_ERROR_OF_MEAN|0.85||0.0045|TWO_SIDED|95.0|0.77|4.14|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||4.14|0.77|0.0045
91686955|NCT00486525|183265990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.28|TWO_SIDED|95.0|-3.0|0.88|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.88|-3.0|0.28
91686956|NCT00486525|183265990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.99||0.21|TWO_SIDED|95.0|-3.2|0.69|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.69|-3.2|0.21
91686957|NCT00486525|183265990|SUPERIORITY_OR_OTHER||Slope|-0.66|STANDARD_ERROR_OF_MEAN|0.34||0.051|TWO_SIDED|95.0|-1.3|0.0039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0039|-1.3|0.051
91686958|NCT00486525|183265990|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.098|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.10|-1.2|0.098
91686959|NCT02548156|183265998|SUPERIORITY_OR_OTHER||Ratio of LS mean|1.52|||<|0.0001|TWO_SIDED|95.0||||From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.|ANCOVA||Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio \>1 favors the first named treatment.|Test and Reference dentifrice combined vs. Comparator dentifrice||||<0.0001
91686960|NCT01473407|183266038|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.25|0.01||||||Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.||0.01|-0.25|
91686961|NCT01473407|183266039|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|5.483|||TWO_SIDED|95.0|-10.4|11.13||||||LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.||11.13|-10.40|
91686962|NCT01473407|183266040|SUPERIORITY_OR_OTHER|||||||0.7563||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.7563
91686963|NCT01473407|183266041|SUPERIORITY_OR_OTHER|||||||0.1061||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.1061
91686964|NCT01473407|183266042|SUPERIORITY_OR_OTHER|||||||0.3369||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.3369
91686965|NCT02422797|183266062|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-3.9|4.2|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI).|||4.2|-3.9|
91686966|NCT02422797|183266064|OTHER||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.8|-4.0|
91720380|NCT00855582|183333580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
91720381|NCT00855582|183333580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
91720382|NCT00855582|183333580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
91488070|NCT03401489|182848230|OTHER|Longitudinal mixed-effects repeated-measures modeling (MMRM) was used to compare systolic BP over time, adjusting for baseline BP, site, and race.|Mean Difference (Final Values)|2.4||||0.623|TWO_SIDED|95.0|-7.3|12.1||Two-sided α=0.05; no adjustment for multiple comparisons.|Mixed Models Analysis||Positive values favor the control arm.|||12.1|-7.3|0.623
91686967|NCT02422797|183266075|OTHER|||||||0.007||||||P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
91686968|NCT02422797|183266075|SUPERIORITY||Odds Ratio (OR)|0.861||||0.011|TWO_SIDED|95.0|0.767|0.967||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.967|0.767|0.011
91686969|NCT02422797|183266075|SUPERIORITY||Odds Ratio (OR)|1.012||||0.745|TWO_SIDED|95.0|0.943|1.085||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||1.085|0.943|0.745
91686970|NCT02422797|183266075|SUPERIORITY||Odds Ratio (OR)|0.877||||0.018|TWO_SIDED|95.0|0.787|0.977||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.977|0.787|0.018
91686971|NCT02422797|183266077|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
91686972|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.728|||<|0.001|TWO_SIDED|95.0|0.686|0.773||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.773|0.686|<.001
91686973|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.865||||0.004|TWO_SIDED|95.0|0.785|0.954||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.954|0.785|0.004
91686974|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.788|||<|0.001|TWO_SIDED|95.0|0.719|0.864||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.864|0.719|<.001
91686975|NCT02422797|183266077|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
91686976|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.867|||<|0.001|TWO_SIDED|95.0|0.823|0.914||P value assessed the difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.914|0.823|<.001
91686977|NCT02422797|183266077|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
91720383|NCT00855582|183333581|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.027
91720384|NCT00855582|183333581|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.186
91488071|NCT03401489|182848231|SUPERIORITY||Mean Difference (Net)|-0.9||||0.614|TWO_SIDED|95.0|-7.8|6.0||Two-sided α=0.05; no adjustment for multiple comparisons.|Mixed Models Analysis||Negative values favor the PACESETTER arm.|Longitudinal mixed-effects repeated-measures modeling (MMRM) was used to compare diastolic BP over time, adjusting for baseline BP, site, and race.||6.0|-7.8|0.614
91686978|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.853|||<|0.001|TWO_SIDED|95.0|0.799|0.91||P value assessed the difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.910|0.799|<.001
91686979|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.886||||0.028|TWO_SIDED|95.0|0.796|0.987||P value assessed the difference between treatment groups (osteocalcin - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.987|0.796|0.028
91686980|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.743|||<|0.001|TWO_SIDED|95.0|0.672|0.822||P value assessed the difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.822|0.672|<.001
91686981|NCT02422797|183266077|OTHER|||||||0.782||||||P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
91686982|NCT02422797|183266077|SUPERIORITY||Odds Ratio (OR)|0.818|||<|0.001|TWO_SIDED|95.0|0.751|0.891||P value assessed the difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.891|0.751|<.001
91488072|NCT01950390|182848232|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.383|ONE_SIDED|90.0||1.23||One-sided|Log Rank|Stratification factors of BRAF mutation status (wild type/mutation) and prior therapy (yes/no) were used in the stratified analysis|One-sided 90% Repeated Confidence Interval for Hazard Ratio with Arm A as Reference|||1.23||0.383
91686983|NCT02422797|183266090|OTHER|||||||0.179||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.179
91686984|NCT02422797|183266090|OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.6|8.6|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||8.6|-1.6|
91686985|NCT02422797|183266090|OTHER||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-12.1|7.4|||||INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||7.4|-12.1|
91488073|NCT01950390|182848233|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.61|1.2||Two-sided|Log Rank|Stratified Log rank test||||1.20|0.61|0.358
91686986|NCT02422797|183266090|OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.9|3.1|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||3.1|-13.9|
91686987|NCT02422797|183266098|OTHER|||||||0.43||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.430
91686988|NCT02422797|183266098|OTHER||Mean Difference (Final Values)|-1.239||||0.039|TWO_SIDED|95.0|-2.414|-0.064||P value assessed the difference between treatment groups (Symptom Bother Score - Week 4)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.064|-2.414|0.039
91686989|NCT02422797|183266098|OTHER|||||||0.542||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.542
91686990|NCT02422797|183266098|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.448|TWO_SIDED|95.0|-1.896|0.84||P value assessed the difference between treatment groups (Symptom Bother Score - Week 24)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.840|-1.896|0.448
91686991|NCT02422797|183266098|OTHER|||||||0.402||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.402
91686992|NCT02422797|183266098|SUPERIORITY||Mean Difference (Final Values)|-1.037||||0.164|TWO_SIDED|95.0|-2.501|0.426||P value assessed the difference between treatment groups (Symptom Bother Score - Week 48)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.426|-2.501|0.164
91686993|NCT02422797|183266101|SUPERIORITY|||||||0.037||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.037
91686994|NCT02422797|183266101|SUPERIORITY|||||||0.101||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.101
91686995|NCT02422797|183266101|SUPERIORITY|||||||0.042||||||P-value assessed the HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.042
91686996|NCT02422797|183266101|SUPERIORITY|||||||0.132||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.132
91488074|NCT01950390|182848234|SUPERIORITY|||||||0.482||||||Two-sided|Chi-squared|||||||0.482
91488075|NCT01950390|182848236|SUPERIORITY|||||||0.937||||||Two-sided|Chi-squared|||||||0.937
91488076|NCT02975336|182848248|SUPERIORITY||Odds Ratio (OR)|1.55||||0.5462|TWO_SIDED|95.0|0.91|2.64|||Regression, Logistic|||||2.64|0.91|0.5462
91488077|NCT02975336|182848248|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5462|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||||2.18|0.76|0.5462
91488078|NCT02975336|182848248|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5462|TWO_SIDED|95.0|0.67|1.93|||Regression, Logistic|||||1.93|0.67|0.5462
91488079|NCT02975336|182848249|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5462|TWO_SIDED|95.0|0.69|3.24|||Regression, Logistic|||||3.24|0.69|0.5462
91686997|NCT02422797|183266101|SUPERIORITY|||||||0.022||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.022
91686998|NCT02422797|183266101|SUPERIORITY|||||||0.004||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.004
91686999|NCT02422797|183266101|SUPERIORITY|||||||0.076||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.076
91687000|NCT02422797|183266101|SUPERIORITY|||||||0.073||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.073
91687001|NCT02422797|183266101|SUPERIORITY|||||||0.547||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.547
91687002|NCT05044195|183266147|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: upper limit (UL) of the 95% confidence interval (CI) for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.802|||||TWO_SIDED|95.0|0.738|0.871||||||A/H1N1||0.871|0.738|
91687003|NCT05044195|183266147|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.9|||||TWO_SIDED|95.0|0.819|0.989||||||A/H3N2||0.989|0.819|
91687004|NCT05044195|183266147|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.944|||||TWO_SIDED|95.0|0.88|1.012||||||B/Yamagata||1.012|0.880|
91687005|NCT05044195|183266147|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.992|||||TWO_SIDED|95.0|0.923|1.067||||||B/Victoria||1.067|0.923|
91687006|NCT05044195|183266148|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-4.4|||||TWO_SIDED|95.0|-7.97|-0.74||||||A/H1N1||-0.74|-7.97|
91687007|NCT05044195|183266148|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-1.8|||||TWO_SIDED|95.0|-6.14|2.48||||||A/H3N2||2.48|-6.14|
91687008|NCT05044195|183266148|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-2.4|||||TWO_SIDED|95.0|-6.77|2.0||||||B/Yamagata||2.00|-6.77|
91687009|NCT05044195|183266148|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-3.9|||||TWO_SIDED|95.0|-8.31|0.45||||||B/Victoria||0.45|-8.31|
91687010|NCT05044195|183266149|SUPERIORITY||GMT ratio|0.808|||||TWO_SIDED|95.0|0.745|0.876||||||A/H1N1||0.876|0.745|
91687011|NCT05044195|183266149|SUPERIORITY||GMT ratio|0.91|||||TWO_SIDED|95.0|0.829|0.998||||||A/H3N2||0.998|0.829|
91687012|NCT05044195|183266149|SUPERIORITY||GMT ratio|0.947|||||TWO_SIDED|95.0|0.884|1.014||||||B/Yamagata||1.014|0.884|
91687013|NCT05044195|183266149|SUPERIORITY||GMT ratio|1.0|||||TWO_SIDED|95.0|0.931|1.075||||||B/Victoria||1.075|0.931|
91687014|NCT05044195|183266150|OTHER||GMT ratio|0.87|||||TWO_SIDED|95.0|0.803|0.944||||||A/H1N1||0.944|0.803|
91687015|NCT05044195|183266150|OTHER||GMT ratio|0.953|||||TWO_SIDED|95.0|0.88|1.032||||||A/H3N2||1.032|0.880|
91687016|NCT05044195|183266150|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.953|1.077||||||B/Yamagata||1.077|0.953|
91687017|NCT05044195|183266150|OTHER||GMT ratio|1.028|||||TWO_SIDED|95.0|0.963|1.098||||||B/Victoria||1.098|0.963|
91687018|NCT05044195|183266158|OTHER||GMT ratio|0.838|||||TWO_SIDED|95.0|0.751|0.936||||||A/H1N1 (50 to 59 years)||0.936|0.751|
91687019|NCT05044195|183266158|OTHER||GMT ratio|0.924|||||TWO_SIDED|95.0|0.821|1.04||||||A/H3N2 (50 to 59 years)||1.040|0.821|
91687020|NCT05044195|183266158|OTHER||GMT ratio|0.926|||||TWO_SIDED|95.0|0.845|1.015||||||B/Yamagata (50 to 59 years)||1.015|0.845|
91687021|NCT05044195|183266158|OTHER||GMT ratio|0.989|||||TWO_SIDED|95.0|0.901|1.087||||||B/Victoria (50 to 59 years)||1.087|0.901|
91687022|NCT05044195|183266158|OTHER||GMT ratio|0.767|||||TWO_SIDED|95.0|0.681|0.864||||||A/H1N1 (60 to 64 years)||0.864|0.681|
91687023|NCT05044195|183266158|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.766|1.033||||||A/H3N2 (60 to 64 years)||1.033|0.766|
91687024|NCT05044195|183266158|OTHER||GMT ratio|0.974|||||TWO_SIDED|95.0|0.879|1.079||||||B/Yamagata (60 to 64 years)||1.079|0.879|
91687025|NCT05044195|183266158|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.905|1.133||||||B/Victoria (60 to 64 years)||1.133|0.905|
91488080|NCT02975336|182848249|SUPERIORITY||Odds Ratio (OR)|1.42||||0.5462|TWO_SIDED|95.0|0.68|2.97|||Regression, Logistic|||||2.97|0.68|0.5462
91687026|NCT05044195|183266159|OTHER||GMT ratio|0.844|||||TWO_SIDED|95.0|0.761|0.935||||||A/H1N1 (yes)||0.935|0.761|
91687027|NCT05044195|183266159|OTHER||GMT ratio|1.01|||||TWO_SIDED|95.0|0.904|1.128||||||A/H3N2 (yes)||1.128|0.904|
91687028|NCT05044195|183266159|OTHER||GMT ratio|0.948|||||TWO_SIDED|95.0|0.883|1.016||||||B/Yamagata (yes)||1.016|0.883|
91687029|NCT05044195|183266159|OTHER||GMT ratio|0.997|||||TWO_SIDED|95.0|0.926|1.073||||||B/Victoria (yes)||1.073|0.926|
91687030|NCT05044195|183266159|OTHER||GMT ratio|0.772|||||TWO_SIDED|95.0|0.677|0.88||||||A/H1N1 (no)||0.880|0.677|
91687031|NCT05044195|183266159|OTHER||GMT ratio|0.801|||||TWO_SIDED|95.0|0.683|0.941||||||A/H3N2 (no)||0.941|0.683|
91687032|NCT05044195|183266159|OTHER||GMT ratio|0.945|||||TWO_SIDED|95.0|0.831|1.076||||||B/Yamagata (no)||1.076|0.831|
91687033|NCT05044195|183266159|OTHER||GMT ratio|1.007|||||TWO_SIDED|95.0|0.881|1.151||||||B/Victoria (no)||1.151|0.881|
91687034|NCT05044195|183266160|OTHER||GMT ratio|0.82|||||TWO_SIDED|95.0|0.752|0.894||||||A/H1N1 (Comorbidity Risk Score \<50)||0.894|0.752|
91687035|NCT05044195|183266160|OTHER||GMT ratio|0.933|||||TWO_SIDED|95.0|0.846|1.029||||||A/H3N2 (Comorbidity Risk Score \<50)||1.029|0.846|
91687036|NCT05044195|183266160|OTHER||GMTratio|0.972|||||TWO_SIDED|95.0|0.904|1.046||||||B/Yamagata (Comorbidity Risk Score \<50)||1.046|0.904|
91687037|NCT05044195|183266160|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.938|1.094||||||B/Victoria (Comorbidity Risk Score \<50)||1.094|0.938|
91687038|NCT05044195|183266160|OTHER||GMT ratio|0.706|||||TWO_SIDED|95.0|0.553|0.902||||||A/H1N1 (Comorbidity Risk Score ≥50)||0.902|0.553|
91687039|NCT05044195|183266160|OTHER||GMT ratio|0.734|||||TWO_SIDED|95.0|0.549|0.982||||||A/H3N2 (Comorbidity Risk Score ≥50)||0.982|0.549|
91687040|NCT05044195|183266160|OTHER||GMT ratio|0.773|||||TWO_SIDED|95.0|0.638|0.935||||||B/Yamagata (Comorbidity Risk Score ≥50)||0.935|0.638|
91687041|NCT05044195|183266160|OTHER||GMT ratio|0.905|||||TWO_SIDED|95.0|0.739|1.107||||||B/Victoria (Comorbidity Risk Score ≥50)||1.107|0.739|
91687042|NCT02276807|183266252|SUPERIORITY||Mean Difference (Final Values)|0.345|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline vs. Week 12) repeated measures ANOVA||||||<0.05
91687043|NCT02276807|183266253|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (time: Baseline vs. week 12) repeated measures ANOVA||||||<0.05
91687044|NCT02276807|183266254|SUPERIORITY||Mean Difference (Final Values)|0.666|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
91687045|NCT02276807|183266255|SUPERIORITY||Mean Difference (Final Values)|0.014|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
91687046|NCT02276807|183266256|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline vs. Week 12) Repeated Measures ANOVA||||||<0.05
91687047|NCT03288714|183266270|SUPERIORITY|||||||0.814|||||||Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.814
91687048|NCT03288714|183266271|SUPERIORITY|||||||0.872|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.872
91687049|NCT03288714|183266272|SUPERIORITY|||||||0.641|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||The null hypothesis is that the active sTMS treatment group does not differ||||.641
91687050|NCT03288714|183266273|SUPERIORITY|||||||0.032||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.032
91687051|NCT03288714|183266274|SUPERIORITY|||||||0.015||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.015
91687052|NCT03288714|183266275|SUPERIORITY|||||||0.028||||||Alpha level: .05|Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||||||.028
91488081|NCT02975336|182848249|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5462|TWO_SIDED|95.0|0.59|2.75|||Regression, Logistic|||||2.75|0.59|0.5462
91488082|NCT02975336|182848277|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.7034|TWO_SIDED|95.0|0.57|2.4|||Cox proportional hazards model|||||2.40|0.57|0.7034
91488083|NCT02975336|182848277|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.5462|TWO_SIDED|95.0|0.31|1.52|||Cox proportional hazards model|||||1.52|0.31|0.5462
91488084|NCT02975336|182848277|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5462|TWO_SIDED|95.0|0.42|1.97|||Cox proportional hazards model|||||1.97|0.42|0.5462
91527068|NCT00697190|182929458|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.34|-0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.08|-0.34|
91687053|NCT00629018|183266361|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||||0.01
91687054|NCT03417778|183266367|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|161.14|||||TWO_SIDED|90.0|80.77|321.48||||||An analysis of variance (ANOVA) model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% confidence intervals (CI) were calculated for the geometric least-squares mean (GLSM) ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||321.48|80.77|
91687055|NCT03417778|183266368|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.08|||||TWO_SIDED|90.0|69.67|213.89||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% CI were calculated for the GLSM ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||213.89|69.67|
91687056|NCT03417778|183266369|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|159.15|||||TWO_SIDED|90.0|82.22|308.06||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||308.06|82.22|
91687057|NCT03417778|183266370|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.32|||||TWO_SIDED|90.0|69.9|214.07||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||214.07|69.90|
91687058|NCT03417778|183266371|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|115.98|||||TWO_SIDED|90.0|58.75|228.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||228.98|58.75|
91488085|NCT02975336|182848278|SUPERIORITY||Odds Ratio (OR)|1.52||||0.5462|TWO_SIDED|95.0|0.74|3.15|||Regression, Logistic|||||3.15|0.74|0.5462
91488086|NCT02975336|182848278|SUPERIORITY||Odds Ratio (OR)|1.03||||0.5462|TWO_SIDED|95.0|0.49|2.13|||Regression, Logistic|||||2.13|0.49|0.5462
91488087|NCT02975336|182848278|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5462|TWO_SIDED|95.0|0.65|2.81|||Regression, Logistic|||||2.81|0.65|0.5462
91488088|NCT02975336|182848279|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2434|TWO_SIDED|95.0|0.73|3.54|||Regression, Logistic|||||3.54|0.73|0.2434
91488089|NCT02975336|182848279|SUPERIORITY||Odds Ratio (OR)|1.62||||0.2389|TWO_SIDED|95.0|0.73|3.63|||Regression, Logistic|||||3.63|0.73|0.2389
91488090|NCT02975336|182848279|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1952|TWO_SIDED|95.0|0.76|3.85|||Regression, Logistic|||||3.85|0.76|0.1952
91488091|NCT02975336|182848280|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.0987|TWO_SIDED|95.0|0.87|2.89|||Cox proportional hazards model|||||2.89|0.87|0.0987
91488092|NCT02975336|182848280|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9201|TWO_SIDED|95.0|0.51|1.85|||Cox proportional hazards model|||||1.85|0.51|0.9201
91488093|NCT02975336|182848280|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.5645|TWO_SIDED|95.0|0.6|2.2|||Cox proportional hazards model|||||2.20|0.60|0.5645
91488094|NCT02975336|182848281|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3743|TWO_SIDED|95.0|0.44|1.37|||Regression, Logistic|||||1.37|0.44|0.3743
91488095|NCT02975336|182848281|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6445|TWO_SIDED|95.0|0.5|1.54|||Regression, Logistic|||||1.54|0.50|0.6445
91488096|NCT02975336|182848281|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2634|TWO_SIDED|95.0|0.41|1.28|||Regression, Logistic|||||1.28|0.41|0.2634
91488097|NCT02975336|182848282|SUPERIORITY||Rate Ratio|1.59||||0.2989|TWO_SIDED|95.0|0.66|3.81||Nominal p-value|Negative binomial regression|||||3.81|0.66|0.2989
91488098|NCT02975336|182848282|SUPERIORITY||Rate Ratio|0.85||||0.7325|TWO_SIDED|95.0|0.33|2.19||Nominal p-value|Negative binomial regression|||||2.19|0.33|0.7325
91488099|NCT02975336|182848282|SUPERIORITY||Rate Ratio|1.29||||0.591|TWO_SIDED|95.0|0.51|3.22||Nominal p-value|Negative binomial regression|||||3.22|0.51|0.5910
91527069|NCT00697190|182929459|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.54|-0.15|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.15|-0.54|
91720385|NCT02832037|183333584|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0145||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0145
91720386|NCT02832037|183333584|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0148||||||Adjusted for multiplicity.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0148
91720387|NCT02832037|183333584|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0089||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809 .||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0089
91720388|NCT02832037|183333584|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0038||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0038
91720389|NCT02832037|183333584|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0085||||||Adjusted for multiplicity.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0085
91720390|NCT02832037|183333584|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.228||||||Adjusted for multiplicity.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2280
91527070|NCT00697190|182929460|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.12|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.14|-0.12|
91527071|NCT00697190|182929461|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.23|0.05|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.05|-0.23|
91527072|NCT00697190|182929462|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.2|0.02|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.02|-0.20|
91720391|NCT02832037|183333584|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.28|STANDARD_ERROR_OF_MEAN|0.8205||0.733|TWO_SIDED|95.0|-1.332|1.892||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.892|-1.332|0.7330
91720392|NCT02832037|183333584|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.137|STANDARD_ERROR_OF_MEAN|0.8074||0.8655|TWO_SIDED|95.0|-1.45|1.724||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.724|-1.450|0.8655
91720393|NCT02832037|183333584|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.982|STANDARD_ERROR_OF_MEAN|0.7875||0.0122|TWO_SIDED|95.0|0.434|3.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.530|0.434|0.0122
91720394|NCT02832037|183333584|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.73|STANDARD_ERROR_OF_MEAN|0.7884||0.0287|TWO_SIDED|95.0|0.181|3.28||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.280|0.181|0.0287
91720395|NCT02832037|183333585|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.066||||||P-value is considered nominal.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0660
91720396|NCT02832037|183333585|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.1619||||||P-value is considered nominal.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1619
91720397|NCT02832037|183333585|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0832||||||P-value is considered nominal.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0832
91720398|NCT02832037|183333585|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0625||||||P-value is considered nominal.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0625
91488100|NCT02975336|182848283|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3635|TWO_SIDED|95.0|0.72|2.47|||Regression, Logistic|||||2.47|0.72|0.3635
91527073|NCT01871558|182929478|SUPERIORITY_OR_OTHER|||||||0.139|||||||Chi-squared|||||||0.139
91527074|NCT01709305|182929487|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.19|||||TWO_SIDED|98.34|0.02|0.36||||||Pairwise Comparison||0.36|0.02|
91488101|NCT02975336|182848283|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0329|TWO_SIDED|95.0|1.06|3.56|||Regression, Logistic|||||3.56|1.06|0.0329
91488102|NCT02975336|182848283|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7619|TWO_SIDED|95.0|0.59|2.07|||Regression, Logistic|||||2.07|0.59|0.7619
91488103|NCT02975336|182848284|SUPERIORITY||Odds Ratio (OR)|1.36||||0.2642|TWO_SIDED|95.0|0.79|2.35|||Regression, Logistic|||||2.35|0.79|0.2642
91488104|NCT02975336|182848284|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1489|TWO_SIDED|95.0|0.87|2.57|||Regression, Logistic|||||2.57|0.87|0.1489
91527075|NCT01709305|182929487|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.03|||||TWO_SIDED|98.34|-0.15|0.21||||||Pairwise Comparison||0.21|-0.15|
91687059|NCT03417778|183266372|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|102.85|||||TWO_SIDED|90.0|60.12|175.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||175.98|60.12|
91687060|NCT01995513|183266388|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.828||||0.2176|TWO_SIDED|95.0|0.612|1.119||P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.119|0.612|0.2176
91720399|NCT02832037|183333585|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0768||||||P-value is considered nominal.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0768
91720400|NCT02832037|183333585|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.7479||||||P-value is considered nominal.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.7479
91720401|NCT02832037|183333585|OTHER||Difference of adjusted means|1.178|STANDARD_ERROR_OF_MEAN|0.7306||0.11|TWO_SIDED|95.0|-0.258|2.613||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||2.613|-0.258|0.11
91720402|NCT02832037|183333585|OTHER||Difference of adjusted means|-0.837|STANDARD_ERROR_OF_MEAN|0.7224||0.25|TWO_SIDED|95.0|-2.257|0.582||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.582|-2.257|0.25
91720403|NCT02832037|183333585|OTHER||Difference of adjusted means|-0.263|STANDARD_ERROR_OF_MEAN|0.7152||0.71|TWO_SIDED|95.0|-1.669|1.142||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.142|-1.669|0.71
91720404|NCT02832037|183333585|OTHER||Difference of adjusted means|-1.072|STANDARD_ERROR_OF_MEAN|0.7125||0.13|TWO_SIDED|95.0|-2.473|0.328||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.328|-2.473|0.13
91720405|NCT04383132|183333589|OTHER|||||||0.388||||||Independent t-test was used to compare mean CIT between two groups. The statistical significance level was accepted as p\<0.05|t-test, 2 sided|||In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.||||0.388
91527076|NCT01709305|182929487|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|-0.05|||||TWO_SIDED|98.34|-0.23|0.14||||||Pairwise Comparison||0.14|-0.23|
91687061|NCT01995513|183266389|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.874||||0.45|TWO_SIDED|95.0|0.617|1.239||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.239|0.617|0.4500
91687062|NCT01995513|183266390|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.65||||0.3101|TWO_SIDED|95.0|-4.82|1.51||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=50% decrease from baseline in PSA response.||1.51|-4.82|0.3101
91720406|NCT04383132|183333590|OTHER|||||||0.069||||||For the comparison of ancillary maneuvers Pearson chi-square test, Fisher's exact test, and Fisher-Freeman-Halton exact test were used.|Chi-squared|||||||0.069
91720407|NCT04383132|183333591|OTHER|||||||0.487||||||Independent t-test was used to compare mean CIL between two groups.|t-test, 2 sided|||||||0.487
91720408|NCT04383132|183333592|OTHER|||||||0.822|||||||Chi-squared|||||||0.822
91720409|NCT04383132|183333593|OTHER|||||||0.016|||||||Chi-squared|||||||0.016
91720410|NCT04383132|183333594|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91720411|NCT04383132|183333595|OTHER|||||||0.184|||||||Fisher Exact|||||||0.184
91720412|NCT04167462|183333619|SUPERIORITY||Odds Ratio (OR)|16.49|||<|0.0001|TWO_SIDED|95.0|6.33|42.98|||Cochran-Mantel-Haenszel|||||42.98|6.33|<0.0001
91488105|NCT02975336|182848284|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9285|TWO_SIDED|95.0|0.56|1.7|||Regression, Logistic|||||1.70|0.56|0.9285
91488106|NCT02975336|182848287|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9061|TWO_SIDED|95.0|0.49|1.88|||Regression, Logistic|||||1.88|0.49|0.9061
91488107|NCT02975336|182848287|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6053|TWO_SIDED|95.0|0.61|2.31|||Regression, Logistic|||||2.31|0.61|0.6053
91488108|NCT02975336|182848287|SUPERIORITY||Odds Ratio (OR)|0.8||||0.52|TWO_SIDED|95.0|0.4|1.59|||Regression, Logistic|||||1.59|0.40|0.5200
91488109|NCT02975336|182848296|SUPERIORITY||Rate difference|5.9|||||TWO_SIDED|95.0|-9.7|21.2||||||||21.2|-9.7|
91488110|NCT02975336|182848296|SUPERIORITY||Rate Difference|0.6|||||TWO_SIDED|95.0|-14.5|15.6||||||||15.6|-14.5|
91488111|NCT02975336|182848296|SUPERIORITY||Rate difference|1.6|||||TWO_SIDED|95.0|-13.5|16.6||||||||16.6|-13.5|
91488112|NCT02975336|182848300|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7728|TWO_SIDED|95.0|0.46|2.82|||Regression, Logistic|||||2.82|0.46|0.7728
91687063|NCT01995513|183266390|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-0.04||||0.9917|TWO_SIDED|95.0|-3.9|3.82||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=30% decrease from baseline in PSA response.||3.82|-3.90|0.9917
91488113|NCT02975336|182848300|SUPERIORITY||Odds Ratio (OR)|0.66||||0.3314|TWO_SIDED|95.0|0.28|1.54|||Regression, Logistic|||||1.54|0.28|0.3314
91488114|NCT02975336|182848300|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7205|TWO_SIDED|95.0|0.36|2.04|||Regression, Logistic|||||2.04|0.36|0.7205
91488115|NCT02975336|182848301|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8364|TWO_SIDED|95.0|0.35|3.71|||Regression, Logistic|||||3.71|0.35|0.8364
91488116|NCT02975336|182848301|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8287|TWO_SIDED|95.0|0.37|3.45|||Regression, Logistic|||||3.45|0.37|0.8287
91488117|NCT02975336|182848301|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7621|TWO_SIDED|95.0|0.35|4.16|||Regression, Logistic|||||4.16|0.35|0.7621
91488118|NCT02975336|182848302|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8464|TWO_SIDED|95.0|0.23|3.31|||Regression, Logistic|||||3.31|0.23|0.8464
91488119|NCT02975336|182848302|SUPERIORITY||Odds Ratio (OR)|0.59||||0.417|TWO_SIDED|95.0|0.16|2.12|||Regression, Logistic|||||2.12|0.16|0.4170
91527077|NCT01709305|182929489|SUPERIORITY_OR_OTHER||Estimate|-8.4|||<|0.001|TWO_SIDED|95.0|-11.1|-6.1|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-6.1|-11.1|<0.001
91720413|NCT04167462|183333620|SUPERIORITY||Odds Ratio (OR)|24.29|||<|0.0001|TWO_SIDED|95.0|9.6|61.46|||Cochran-Mantel-Haenszel|||||61.46|9.60|<0.0001
91488120|NCT02975336|182848302|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9988|TWO_SIDED|95.0|0.27|3.74|||Regression, Logistic|||||3.74|0.27|0.9988
91488121|NCT02975336|182848303|SUPERIORITY||Odds Ratio (OR)|1.13||||0.697|TWO_SIDED|95.0|0.62|2.04|||Regression, Logistic|||||2.04|0.62|0.6970
91488122|NCT02975336|182848303|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3234|TWO_SIDED|95.0|0.75|2.42|||Regression, Logistic|||||2.42|0.75|0.3234
91488123|NCT02975336|182848303|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9846|TWO_SIDED|95.0|0.54|1.82|||Regression, Logistic|||||1.82|0.54|0.9846
91488124|NCT02495831|182848304|SUPERIORITY_OR_OTHER||point estimate (ratio of geometric means|90.0||||0.1|TWO_SIDED|90.0|80.0|125.0||If the upper limit of the 90% confidence interval is \< 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).|ANOVA|||The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.||125|80|0.1
91488125|NCT02495831|182848305|SUPERIORITY_OR_OTHER||geometric mean ratio|104.84|||||TWO_SIDED|90.0|96.4|114.02||||||||114.02|96.40|
91488126|NCT02281773|182848318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1256|TWO_SIDED|95.0|-2.76|0.34||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.34|-2.76|0.1256
91488127|NCT02281773|182848318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.8||0.7337|TWO_SIDED|95.0|-1.3|1.84||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.84|-1.30|0.7337
91489402|NCT02484690|182851581|SUPERIORITY||Difference in Least Squares Means|0.23||||0.8131|TWO_SIDED|80.0|-1.01|1.47||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.47|-1.01|0.8131
91527078|NCT01709305|182929489|SUPERIORITY_OR_OTHER||Estimate|-2.9||||0.072|TWO_SIDED|95.0|-6.1|0.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.3|-6.1|0.072
91720414|NCT04167462|183333621|SUPERIORITY||Odds Ratio (OR)|41.19|||<|0.0001|TWO_SIDED|95.0|5.82|291.26|||Cochran-Mantel-Haenszel|||||291.26|5.82|<0.0001
91488128|NCT02281773|182848318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6994|TWO_SIDED|95.0|-1.31|1.95||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.95|-1.31|0.6994
91488129|NCT02281773|182848318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.79||0.427|TWO_SIDED|95.0|-2.19|0.93||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.93|-2.19|0.4270
91488130|NCT02281773|182848323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.66||0.5972|TWO_SIDED|95.0|-0.9|1.6||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.6|-0.9|0.5972
91488131|NCT02281773|182848323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3817|TWO_SIDED|95.0|-1.9|0.7||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.7|-1.9|0.3817
91489403|NCT02484690|182851581|SUPERIORITY||Difference in Least Squares Means|0.11||||0.9069|TWO_SIDED|80.0|-1.07|1.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between each of the treatment groups (Arms B, C, or D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arms B, C, or D means were different from Arm A mean.||1.29|-1.07|0.9069
91527079|NCT01709305|182929489|SUPERIORITY_OR_OTHER||Estimate|-5.3|||<|0.001|TWO_SIDED|95.0|-8.3|-2.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-2.5|-8.3|<0.001
91527080|NCT01709305|182929490|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
91527081|NCT01709305|182929490|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
91687064|NCT01995513|183266391|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|-5.0||||0.1653|TWO_SIDED|95.0|-11.75|1.75||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR.||1.75|-11.75|0.1653
91527082|NCT01709305|182929490|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
91527083|NCT01709305|182929491|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.998|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.998
91527084|NCT01709305|182929491|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.319|TWO_SIDED|95.0|-1.0|0.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.5|-1.0|0.319
91687065|NCT01995513|183266391|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|10.92||||0.3216|TWO_SIDED|95.0|-10.37|32.21||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR+SD.||32.21|-10.37|0.3216
91687066|NCT01995513|183266392|SUPERIORITY_OR_OTHER_LEGACY||Difference in Progression Rate|9.09||||0.2963|TWO_SIDED|95.0|-7.69|25.87||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in Progression Rate was based upon normal approximation.|||25.87|-7.69|0.2963
91687067|NCT01995513|183266393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.861||||0.3818|TWO_SIDED|95.0|0.616|1.204||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.204|0.616|0.3818
91720415|NCT04167462|183333625|SUPERIORITY||Odds Ratio (OR)|17.27|||<|0.0001|TWO_SIDED|95.0|6.06|49.25|||Cochran-Mantel-Haenszel|||||49.25|6.06|<0.0001
91720416|NCT04167462|183333626|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.0001|TWO_SIDED|95.0|2.19|11.91|||Cochran-Mantel-Haenszel|||||11.91|2.19|<0.0001
91488132|NCT02281773|182848323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68||0.48|TWO_SIDED|95.0|-0.9|1.8||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.8|-0.9|0.4800
91488133|NCT02281773|182848323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7507|TWO_SIDED|95.0|-1.1|1.5||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.5|-1.1|0.7507
91687068|NCT01995513|183266400|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.399||||0.0739|TWO_SIDED|95.0|0.967|2.025||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||2.025|0.967|0.0739
91687069|NCT01232452|183266405|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.848|TWO_SIDED|95.0|0.73|1.47|||Log Rank|||||1.47|0.73|0.848
91687070|NCT01232452|183266406|SUPERIORITY|||||||0.338|||||||Fisher Exact|||||||0.338
91687071|NCT00247676|183266423|SUPERIORITY_OR_OTHER||clinical benefit response rate|37.8||||||95.0|22.5|55.2|||||Clinical benefit response rate: percent of patients with confirmed CR, confirmed PR, or SD for at least 12 weeks according to RECIST, relative to total treated patients.|||55.2|22.5|
91687072|NCT00247676|183266428|SUPERIORITY_OR_OTHER||objective response rate|2.7||||||95.0|0.1|14.2|||||percentage of patients with confirmed CR or confirmed PR according to RECIST, relative to the total number of treated patients.|||14.2|0.1|
91687073|NCT00247676|183266432|SUPERIORITY_OR_OTHER||probability|0.324||||||95.0|0.168|0.479|||||probability derived from Kaplan-Meier estimate.|||0.479|0.168|
91687074|NCT05219448|183266454|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.17|TWO_SIDED|95.0|-3.2|18.0||Unadjusted p value presented. The a priori threshold for statistical significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same when compared to children in the no-treatment control arm (measured through hair biomarker).||18.0|-3.2|0.17
91687075|NCT05219448|183266455|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.6|TWO_SIDED|95.0|-24.3|14.0||Unadjusted P-value. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community A arm when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||14.0|-24.3|0.60
91687076|NCT05219448|183266455|SUPERIORITY||Mean Difference (Final Values)|-24.7||||0.013|TWO_SIDED|95.0|-44.1|-5.4||The P-value is unadjusted. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community B when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||-5.4|-44.1|0.013
91687077|NCT01750190|183266456|SUPERIORITY||Least Square Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|1.735|1.967|||ANCOVA|MI (Multiple Imputation) ANCOVA|Roxadustat - Placebo Treatment Difference|Treatment comparison was made using the multiple imputation strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb and baseline estimated glomerular filtration rate (eGFR) as covariates and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 milliliters \[mL\]/minutes \[min\]/1.73 meters \[m\]\^2), as fixed effects.||1.967|1.735|<0.0001
91687078|NCT01750190|183266457|SUPERIORITY||Odds Ratio (OR)|77.56|||<|0.0001|TWO_SIDED|95.0|44.73|134.48|||Cochran-Mantel-Haenszel||Roxadustat/Placebo Odds ratio|||134.48|44.73|<0.0001
91687079|NCT01750190|183266458|SUPERIORITY||Least Square Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|1.73|2.037|||Mixed Models Analysis|MMRM Analysis|Roxadustat - placebo treatment difference|Treatment comparison was made using MMRM with baseline Hb and baseline eGFR as covariates, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2), as fixed effects.||2.037|1.730|<0.0001
91687080|NCT01750190|183266459|SUPERIORITY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|1.663|2.143|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb and baseline eGFR as covariates , and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2 ), as fixed effects.||2.143|1.663|<0.0001
91687081|NCT01750190|183266460|SUPERIORITY||Odds Ratio (OR)|15.47|||<|0.0001|TWO_SIDED|95.0|10.79|22.189|||Cochran-Mantel-Haenszel||Roxadustat/placebo odds ratio|||22.189|10.79|<0.0001
91687082|NCT01750190|183266461|SUPERIORITY||Least Square Mean Difference|-17.26|STANDARD_ERROR_OF_MEAN|1.73|<|0.0001|TWO_SIDED|95.0|-20.65|-13.87|||Mixed Models Analysis|MMRM Analysis|Roxadustat- placebo treatment difference|Treatment comparison was made using MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors as fixed effects.||-13.87|-20.65|<0.0001
91687083|NCT01750190|183266462|SUPERIORITY||Least Square Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.528||0.6924|TWO_SIDED|95.0|-0.827|1.245|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|||1.245|-0.827|0.6924
91720417|NCT04167462|183333627|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0947|TWO_SIDED|95.0|0.64|53.28|||Cochran-Mantel-Haenszel|||||53.28|0.64|0.0947
91488134|NCT02281773|182848324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9399|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9399
91488135|NCT02281773|182848324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9919|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9919
91488136|NCT02281773|182848324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3027|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3027
91488137|NCT02281773|182848324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3901|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3901
91488138|NCT03019575|182848335|OTHER|Linear Mixed Model|Geometric Mean Ratio|9.43|||||TWO_SIDED|95.0|7.44|11.97||||||||11.97|7.44|
91488139|NCT03792191|182848352|SUPERIORITY||Median Difference (Final Values)|0.00007||||0.62|TWO_SIDED|95.0|-0.00005|1.0|||Wilcoxon (Mann-Whitney)|||||1|-0.00005|0.62
91488140|NCT03792191|182848353|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
91488141|NCT03792191|182848354|SUPERIORITY||Risk Difference (RD)|-0.036||||0.6|TWO_SIDED|95.0|-0.15|0.079|||Chi-squared, Corrected|||||0.079|-0.15|0.6
91687084|NCT01750190|183266463|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.165|0.406||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||||0.406|0.165|<0.0001
91720418|NCT04167462|183333628|SUPERIORITY||Odds Ratio (OR)|4.11||||0.1741|TWO_SIDED|95.0|0.47|35.74|||Cochran-Mantel-Haenszel|||||35.74|0.47|0.1741
91720419|NCT02320396|183333632|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.14|-0.51|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in TNSS was estimated using a constrained longitudinal data analysis (cLDA) model, where both BL and post-BL measurements (average score of 2 weeks) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.||-0.51|-1.14|<0.001
91488142|NCT03792191|182848355|SUPERIORITY||Risk Difference (RD)|-0.021||||0.77|TWO_SIDED|95.0|-0.125|0.082|||Chi-squared, Corrected|||||0.082|-0.125|0.77
91687085|NCT01750190|183266464|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.108|0.267||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and the randomization stratification factors, except baseline Hb (\<=8 g/dL versus \>8 g/dL) and eGFR (\<30 versus \>=30 mL/min/1.73m\^2).|Cox Proportional hazards model|||First 24 Weeks of Treatment||0.267|0.108|<0.0001
91488143|NCT03792191|182848356|SUPERIORITY||Median Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-1|0.077
91720420|NCT02320396|183333635|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.82|||<|0.001|TWO_SIDED|95.0|-1.14|-0.5|||cLDA model|||"Change from BL in TNSS at Week 1: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in TNSS was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.50|-1.14|<0.001
91488144|NCT03792191|182848357|SUPERIORITY||Median Difference (Final Values)|0.00003||||0.1|TWO_SIDED|95.0|-0.00001|0.00003|||Wilcoxon (Mann-Whitney)|||||0.00003|-0.00001|0.1
91488145|NCT03792191|182848358|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
91488146|NCT03792191|182848359|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
91488147|NCT03792191|182848361|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91488148|NCT01856907|182848367|SUPERIORITY|||||||0.035|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.035
91488149|NCT01856907|182848368|SUPERIORITY|||||||0.044|||||||ANOVA|||Subjects (SS)/ Treatment Group x repeated measures (visit) design||||0.044
91488150|NCT01856907|182848369|SUPERIORITY|||||||0.034|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.034
91488151|NCT01856907|182848370|SUPERIORITY|||||||0.047|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||.047
91488152|NCT01856907|182848371|SUPERIORITY|||||||0.017|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.017
91488153|NCT01856907|182848372|SUPERIORITY|||||||0.014|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.014
91488154|NCT01856907|182848373|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.042
91488155|NCT01856907|182848374|SUPERIORITY|||||||0.002|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.002
91488156|NCT01856907|182848375|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
91488157|NCT01856907|182848376|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
91687086|NCT01750190|183266464|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.138|0.276||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||First 52 Weeks of Treatment||0.276|0.138|<0.0001
91687087|NCT05387889|183266489|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.054|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.054
91687088|NCT05387889|183266490|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.25|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.25
91687089|NCT05387889|183266491|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.07|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.07
91687090|NCT03762239|183266494|SUPERIORITY||Relative (percent) changes in the median|1.37||||0.52|TWO_SIDED|95.0|-2.81|5.56|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in better performance, relative to the classroom without air filter (normal air), in attention measures among adolescents in high schools.||5.56|-2.81|0.52
91687091|NCT03762239|183266495|SUPERIORITY||Beta coefficient|0.013||||0.72|TWO_SIDED|95.0|-0.0607|0.0865|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher riskloving behavior, relative to the classroom without air filter (normal air), in the combined risk taking measures among adolescents in high schools.||0.0865|-0.0607|0.72
91687092|NCT03762239|183266496|SUPERIORITY||Beta coefficient|-0.029||||0.5|TWO_SIDED|95.0|-0.117|0.0584|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of patience, relative to the classroom without air filter (normal air), in the combined patience measures among adolescents in high schools.||0.0584|-0.1170|0.50
91687093|NCT03762239|183266497|SUPERIORITY||Beta coefficient|0.06||||0.13|TWO_SIDED|95.0|-0.0184|0.1394|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of positive reciprocity behavior, relative to the classroom without air filter (normal air), in the positive reciprocity measures among adolescents in high schools||0.1394|-0.0184|0.13
91687094|NCT03762239|183266498|SUPERIORITY||Beta coefficient|0.022||||0.58|TWO_SIDED|95.0|-0.0595|0.1035|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher Altruism behavior, relative to the classroom without air filter (normal air), in the Altruism measures among adolescents in high schools.||0.1035|-0.0595|0.58
91687095|NCT03762239|183266499|SUPERIORITY||Beta coefficient|0.013||||0.89|TWO_SIDED|95.0|-0.1786|0.2049|||Ordered logistic regression|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher trust, relative to the classroom without air filter (normal air), in the subjective trust measure among adolescents in high schools.||0.2049|-0.1786|0.89
91687096|NCT03762239|183266500|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5|TWO_SIDED|95.0|-0.49|0.24|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.24|-0.49|0.50
91687097|NCT03762239|183266501|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.47|TWO_SIDED|95.0|-0.2|0.1|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.10|-0.20|0.47
91687098|NCT03762239|183266502|SUPERIORITY||Mean Difference (Final Values)|-3.38||||0.2|TWO_SIDED|95.0|-8.51|1.74|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||1.74|-8.51|0.20
91687099|NCT03762239|183266503|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.92|TWO_SIDED|95.0|-5.1|4.6|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||4.60|-5.10|0.92
91687100|NCT03762239|183266504|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.46|TWO_SIDED|95.0|-4.94|2.22|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||2.22|-4.94|0.46
91720421|NCT02320396|183333635|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.84|||<|0.001|TWO_SIDED|95.0|-1.23|-0.46|||cLDA model|||"Change from BL in TNSS at Week 2: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.46|-1.23|<0.001
91720422|NCT02320396|183333636|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL to Week 1 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
91720423|NCT02320396|183333636|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21|||<|0.001|TWO_SIDED|95.0|-0.32|-0.1|||cLDA model|||"Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.10|-0.32|<0.001
91720424|NCT02320396|183333636|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.008|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.008
91720425|NCT02320396|183333636|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.27|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.38|<0.001
91488158|NCT01856907|182848377|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
91720426|NCT02320396|183333637|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.36|-0.13|||cLDA model|||"Change from BL to Week 2 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.13|-0.36|<0.001
91720427|NCT02320396|183333637|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
91720428|NCT02320396|183333637|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.037|TWO_SIDED|95.0|-0.18|-0.01|||cLDA model|||"Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.01|-0.18|0.037
91720429|NCT02320396|183333637|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||cLDA model|||"Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.40|<0.001
91720430|NCT02320396|183333638|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Sneezing During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
91488159|NCT01436396|182848378|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|0.334|||||TWO_SIDED|95.0|-0.976|1.87||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||1.87|-0.976|
91488160|NCT01436396|182848379|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|-1.06|||||TWO_SIDED|95.0|-2.81|0.383||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||0.383|-2.81|
91488161|NCT01479127|182848397|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Paired t-test|||"TRS I OFF state"||||0.058
91488162|NCT01479127|182848397|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Paired t-test|||"TRS I Dyskinesia state"||||1.000
91488163|NCT01479127|182848397|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Paired t-test|||"TRS II Normal state"||||0.153
91488164|NCT01479127|182848397|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Paired t-test|||"TRS II OFF state"||||0.140
91488165|NCT01479127|182848397|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||"TRS II Dyskinesia state"||||0.374
91687101|NCT03762239|183266505|SUPERIORITY||Beta coefficient|-0.1446||||0.232|TWO_SIDED|95.0|-0.382|0.0928|||Ordered logistic regression|Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher assessment of math skills, relative to the classroom without air filter (normal air), in the self assessed math skills measure among adolescents in high schools.||0.0928|-0.3820|0.232
91687102|NCT00535405|183266506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.5|-12.0||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-12.0|-17.5|<0.001
91687103|NCT00535405|183266506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.3|-4.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-4.8|-10.3|<0.001
91687104|NCT00535405|183266506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.0|-5.5||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-5.5|-11.0|<0.001
91687105|NCT00535405|183266507|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|12.62|STANDARD_ERROR_OF_MEAN|3.23|<|0.001||95.0|7.64|20.83||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|"Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.~Generalized Estimating Equations (GEE)"|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||20.83|7.64|<0.001
91687106|NCT00535405|183266507|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.83|STANDARD_ERROR_OF_MEAN|0.83|<|0.001||95.0|2.51|5.85||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.85|2.51|<0.001
91687107|NCT00535405|183266507|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.66|STANDARD_ERROR_OF_MEAN|0.79|<|0.001||95.0|2.39|5.6|||Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.60|2.39|<0.001
91488166|NCT01479127|182848398|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||||||0.574
91527085|NCT01709305|182929491|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.999|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.999
91720431|NCT02320396|183333638|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.12|||cLDA model|||"Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.33|<0.001
91527086|NCT01709305|182929492|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.651
91687108|NCT00535405|183266508|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.05|STANDARD_ERROR_OF_MEAN|0.62|<|0.001||95.0|2.04|4.55||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.55|2.04|<0.001
91488167|NCT01479127|182848398|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD||||0.661
91488168|NCT01479127|182848398|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD + time w/ TD||||0.574
91488169|NCT01479127|182848399|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Rapid alternating movement of hands||||0.500
91488170|NCT01479127|182848399|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||Arising from chair||||1.000
91488171|NCT01479127|182848399|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Postural stability||||0.250
91488172|NCT01479127|182848399|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Body bradykinesia and hypokinesia||||0.500
91488173|NCT01479127|182848399|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Dyskinesia||||0.250
91488174|NCT01479127|182848400|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Paired t-test|||Total score||||0.870
91488175|NCT01479127|182848400|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||Part I||||0.374
91488176|NCT01479127|182848400|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Part II||||0.799
91488177|NCT01479127|182848400|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Paired t-test|||Part II (Off-time)||||0.493
91488178|NCT01479127|182848400|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Paired t-test|||Part III||||0.530
91527087|NCT01709305|182929492|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.660
91527088|NCT01709305|182929492|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.48|TWO_SIDED|95.0|-0.8|1.6|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.6|-0.8|0.480
91687109|NCT00535405|183266508|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.54|STANDARD_ERROR_OF_MEAN|0.32||0.039||95.0|1.02|2.32||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.32|1.02|0.039
91687110|NCT00535405|183266508|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.81|STANDARD_ERROR_OF_MEAN|0.43||0.023||95.0|1.14|2.87||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.87|1.14|0.023
91687111|NCT00535405|183266509|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|4.47|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|2.76|7.24||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||7.24|2.76|<0.001
91687112|NCT00535405|183266509|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.77|STANDARD_ERROR_OF_MEAN|0.46||0.026||95.0|1.07|2.94||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.94|1.07|0.026
91687113|NCT00535405|183266509|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.27|STANDARD_ERROR_OF_MEAN|0.71||0.017||95.0|1.23|4.18||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.18|1.23|0.017
91687114|NCT00535405|183266510|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|7.6|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|4.31|13.42||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.42|4.31|<0.001
91687115|NCT00535405|183266510|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.95|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0|1.86|4.67||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.67|1.86|<0.001
91687116|NCT00535405|183266510|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.15|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|1.42|3.27||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||3.27|1.42|<0.001
91687117|NCT00535405|183266511|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|6.02|STANDARD_ERROR_OF_MEAN|2.45|<|0.001||95.0|2.71|13.38||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.38|2.71|<0.001
91687118|NCT00535405|183266511|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.67|STANDARD_ERROR_OF_MEAN|0.47||0.069||95.0|0.96|2.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.60|0.96|0.069
91687119|NCT00535405|183266511|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.78|STANDARD_ERROR_OF_MEAN|0.44||0.039|TWO_SIDED|95.0|1.1|2.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.90|1.10|0.039
91687120|NCT03295630|183266519|OTHER||Mean Difference (Final Values)|-17.7|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count||||
91687121|NCT03295630|183266519|OTHER||Intraclass Correlation Coefficient|0.46|||||TWO_SIDED|95.0|-0.1|0.78||||||Correlation between accelerometer quantified step count (thigh placement) and observed step count||0.78|-0.1|
91687122|NCT03295630|183266519|OTHER||Mean Difference (Final Values)|-0.84|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count||||
91687123|NCT03295630|183266519|OTHER||Intraclass Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.99|1.0||||||Correlation between accelerometer quantified steps (ankle placement) and observed steps||1.0|0.99|
91720432|NCT02320396|183333638|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.009|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.009
91488179|NCT01479127|182848400|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Paired t-test|||Part IV sub-score of dyskinesia||||0.108
91687124|NCT03091179|183266539|EQUIVALENCE|P value was calculated using the means and standard deviations for each of the patient characteristics.||||||0.006|||||||t-test, 2 sided|||||||0.006
91488180|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Paired t-test|||Total score||||0.636
91720433|NCT02320396|183333638|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.~cLDA model"||-0.15|-0.38|<0.001
91720434|NCT02320396|183333639|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
91720435|NCT02320396|183333639|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.08|||cLDA model|||"Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.08|-0.24|<0.001
91720436|NCT02320396|183333639|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
91720437|NCT02320396|183333640|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
91720438|NCT02320396|183333640|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.13||||0.01|TWO_SIDED|95.0|-0.24|-0.03|||cLDA model|||"Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.03|-0.24|0.010
91720439|NCT02320396|183333640|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
91720440|NCT02320396|183333641|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Eye Pruritus During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
91488181|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED||||||Paired t-test|||Domain: Mobility||||0.329
91488182|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.902|TWO_SIDED||||||Paired t-test|||Domain: Activities of daily living||||0.902
91488183|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Domain: Emotional well-being||||0.220
91488184|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Domain: Stigma||||0.799
91488185|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED||||||Paired t-test|||Domain: Social support||||0.178
91488186|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Paired t-test|||Domain: Cognition||||0.456
91488187|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.866|TWO_SIDED||||||Paired t-test|||Domain: Communication||||0.866
91488188|NCT01479127|182848401|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Paired t-test|||Domain: Bodily discomfort||||0.576
91488189|NCT01479127|182848402|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"On state staging"||||1.000
91488190|NCT01479127|182848402|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"Off state staging"||||1.000
91488191|NCT01479127|182848403|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Wilcoxon one-sample test|||||||0.125
91488192|NCT01479127|182848408|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Paired t-test|||||||0.074
91488193|NCT03469934|182848418|OTHER||Least Squares (LS) Mean Difference|-0.058||||0.5703|TWO_SIDED|95.0|-0.265|0.15|||Mixed-model repeated measures|||Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.150|-0.265|0.5703
91687125|NCT03164616|183266563|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00093|TWO_SIDED|95.0|0.62|0.885||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and confidence interval (CI) were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. A hazard ratio (HR) \<1 favors D + SoC to be associated with a longer PFS than SoC alone.||0.885|0.620|0.00093
91687126|NCT03164616|183266564|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07581|TWO_SIDED|95.0|0.724|1.016||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer OS than SoC alone.||1.016|0.724|0.07581
91687127|NCT03164616|183266565|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00031|TWO_SIDED|95.0|0.6|0.86||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS than SoC alone.||0.860|0.600|0.00031
91687128|NCT03164616|183266566|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00304|TWO_SIDED|95.0|0.65|0.916||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer OS than SoC alone.||0.916|0.650|0.00304
91687129|NCT03164616|183266567|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.382|2.619||||||D + SoC vs SoC alone. An odds ratio \>1 favors D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.619|1.382|
91687130|NCT03164616|183266567|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.26|2.367||||||T + D + SoC vs SoC alone. An odds ratio \>1 favors T + D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs TC \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.367|1.260|
91687131|NCT03164616|183266570|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.666|0.928|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer PFS2 than SoC alone.||0.928|0.666|
91687132|NCT03164616|183266570|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.632|0.883|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS2 than SoC alone.||0.883|0.632|
91687133|NCT02503787|183266606|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.||||<0.01
91687134|NCT02374138|183266654|SUPERIORITY|||||||0.93||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Months||||0.93
91687135|NCT02374138|183266655|SUPERIORITY|||||||0.87||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 month follow up||||0.87
91687136|NCT02374138|183266655|SUPERIORITY|||||||0.25||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.25
91720441|NCT02320396|183333641|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15|||<|0.001|TWO_SIDED|95.0|-0.23|-0.07|||cLDA model|||"Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.23|<0.001
91687137|NCT02374138|183266657|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 6 Month Follow Up||||0.35
91687138|NCT02374138|183266657|SUPERIORITY|||||||0.34||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 12 Month Follow Up||||0.34
91527089|NCT01709305|182929493|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
91527090|NCT01709305|182929493|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
91527091|NCT01709305|182929493|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
91687139|NCT02374138|183266657|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA Use at 6 Months||||0.35
91687140|NCT02374138|183266657|SUPERIORITY|||||||0.62||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA use at 12 Month Follow Up||||0.62
91720442|NCT02320396|183333641|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value||-0.15|-0.35|<0.001
91488194|NCT03469934|182848422|OTHER||LS Mean Difference|-0.05||||0.5901|TWO_SIDED|95.0|-0.239|0.139|||Mixed-model repeated measures|||MMRM analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.139|-0.239|0.5901
91687141|NCT02374138|183266658|SUPERIORITY|||||||0.63||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED visits over 6 months||||0.63
91687142|NCT02374138|183266658|SUPERIORITY|||||||0.44||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED Visits between 6 and 12 Month follow up||||0.44
91687143|NCT02374138|183266659|SUPERIORITY|||||||0.98||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids over 6 months||||0.98
91687144|NCT02374138|183266659|SUPERIORITY|||||||0.48||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids between 6m and 12m FU||||0.48
91687145|NCT02374138|183266660|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.32
91687146|NCT02374138|183266660|SUPERIORITY|||||||0.06||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.06
91687147|NCT02374138|183266661|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month follow up||||0.32
91687148|NCT02374138|183266661|SUPERIORITY|||||||0.44||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.44
91687149|NCT02374138|183266662|SUPERIORITY|||||||0.7||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.70
91687150|NCT02374138|183266662|SUPERIORITY|||||||0.8||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.80
91687151|NCT02374138|183266663|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||6 Month Follow Up||||0.53
91687152|NCT02374138|183266663|SUPERIORITY|||||||0.77||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||12 Month Follow up||||0.77
91687153|NCT02374138|183266664|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 6 Month Follow up||||0.53
91488195|NCT03469934|182848423|OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.164||0.596|TWO_SIDED|95.0|-0.25|0.43|||ANCOVA|||Change from baseline for FEV1 was compared between etokimab and placebo using an analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and participant as a random effect||0.43|-0.25|0.5960
91687154|NCT02374138|183266664|SUPERIORITY|||||||0.57||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 12 Month Follow up||||0.57
91687155|NCT02374138|183266665|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91687156|NCT02374138|183266668|SUPERIORITY|||||||0.58||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on Brief COPE at 12 Months||||0.58
91687157|NCT02374138|183266670|SUPERIORITY|||||||0.46||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 6 Month Follow Up||||0.46
91687158|NCT02374138|183266670|SUPERIORITY|||||||0.62||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 12 Month Follow Up||||0.62
91687159|NCT02374138|183266672|SUPERIORITY|By repeated measures, p-value adjusted for age and gender||||||0.35|||||||Generalized Linear Model Analysis|||||||0.35
91687160|NCT02374138|183266673|SUPERIORITY|Daytime asthma symptoms in prior 14d at 6-month follow up||||||0.54|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.54
91687161|NCT02374138|183266673|SUPERIORITY|Daytime Asthma Symptoms at 12 month follow up||||||0.11|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.11
91687162|NCT02374138|183266673|SUPERIORITY|Days of Activity Limitations at 6 month follow up||||||0.82|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.82
91687163|NCT02374138|183266673|SUPERIORITY|Days of Activity Limitations at 12 month follow up||||||0.84|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.84
91687164|NCT02374138|183266673|SUPERIORITY|Days of Quick Relief Medicine Use at 6 month follow up||||||0.7|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.70
91687165|NCT02374138|183266673|SUPERIORITY|Days of Quick Relief Medicine Use at 12 month follow up||||||0.58|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.58
91687166|NCT02374138|183266674|OTHER|Univariate test||||||0.2|||||||Chi-squared|||Parent education||||0.20
91687167|NCT02374138|183266675|SUPERIORITY|||||||0.91||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS exposure at 6 Month Follow Up||||0.91
91687168|NCT02374138|183266675|SUPERIORITY|||||||0.98||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS Exposure at 12 Month Follow up||||0.98
91687169|NCT02374138|183266676|OTHER|Univariate test||||||0.94|||||||Chi-squared|||||||0.94
91687170|NCT02374138|183266677|SUPERIORITY|||||||0.02||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 6 Months||||0.02
91488196|NCT03469934|182848424|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|9.823||0.7993|TWO_SIDED|95.0|-17.9|22.96|||ANCOVA|||Change from baseline for FeNO was compared between etokimab and placebo using an ANCOVA with treatment as fixed effect and baseline result as covariate and participant as a random effect||22.96|-17.90|0.7993
91687171|NCT02374138|183266677|SUPERIORITY|||||||0.85||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 12 Months||||0.85
91687172|NCT02374138|183266678|OTHER|Univariate test||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
91720443|NCT02320396|183333642|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.07|||cLDA model|||"Change from BL to Week 1 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.24|<0.001
91720444|NCT02320396|183333642|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19|||<|0.001|TWO_SIDED|95.0|-0.3|-0.09|||cLDA model|||"Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.09|-0.30|<0.001
91720445|NCT02320396|183333642|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17|||<|0.001|TWO_SIDED|95.0|-0.26|-0.08|||cLDA model|||"Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value."||-0.08|-0.26|<0.001
91720446|NCT02320396|183333643|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.492||||0.071|TWO_SIDED|95.0|0.966|2.303|||Regression, Logistic|||"Impression Rate as Assessed by Investigator: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo."||2.303|0.966|0.071
91720447|NCT02320396|183333644|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.149|||<|0.001|TWO_SIDED|95.0|1.408|3.28|||Regression, Logistic|||"Impression Rate as Assessed by Participant: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo"||3.280|1.408|<0.001
91720448|NCT00142415|183333646|OTHER|The maximum tolerated dose (MTD) was determined using a standard 3 + 3 dose-escalation design. The occurrence of DLTs was compared across cohorts.|Maximum tolerated dose (mCi/m^2)|65.0|||||TWO_SIDED|||||||||||||
91720449|NCT04497883|183333690|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|110.41|||||TWO_SIDED|90.0|91.7|132.94|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||132.94|91.70|
91720450|NCT04497883|183333691|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|122.49|||||TWO_SIDED|90.0|96.83|154.95|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||154.95|96.83|
91720451|NCT04497883|183333692|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|125.08|||||TWO_SIDED|90.0|97.99|159.64|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||159.64|97.99|
91488197|NCT05280782|182848438|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Systolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Systolic Blood Pressure values were normal.|||
91720452|NCT04848480|183333744|NON_INFERIORITY|Non-inferiority was considered confirmed if the estimated treatment difference was below 0.3%.|Treatment difference|0.05||||0.0065|TWO_SIDED|95.0|-0.13|0.23|||ANCOVA|||Change from baseline in HbA1c after 26 weeks was analysed using ANCOVA model with treatment, region, HbA1c group at screening and pre-trial basal insulin treatment as fixed factors, and baseline response as covariate.||0.23|-0.13|0.0065
91720453|NCT04428151|183333769|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.9963|TWO_SIDED|95.0|1.11|1.97||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.97|1.11|0.9963
91687173|NCT02933255|183266696|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD8+T cell infiltration within the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
91687174|NCT02933255|183266696|OTHER|||||||0.04||||||The reported p-value is representative of changes in CD8+T cell infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.04
91687175|NCT02933255|183266696|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD8+T cell infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
91488198|NCT05280782|182848438|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Diastolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Diastolic Blood Pressure values were normal.|||
91488199|NCT05280782|182848439|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Heart Rate values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Heart Rate values were normal.|||
91488200|NCT05280782|182848440|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Respiratory Rate values. The values were categorized as Normal or Abnormal.||||||0.016||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.016
91488201|NCT05280782|182848441|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Temperature values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Temperature values were normal.|||
91488202|NCT05280782|182848442|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
91488203|NCT05280782|182848443|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
91488204|NCT05280782|182848444|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Sodium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Sodium values were normal.|||
91687176|NCT02933255|183266696|OTHER|||||||0.46||||||The reported p-value is representative of changes in CD8+T cell infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.46
91488205|NCT05280782|182848444|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Potassium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Potassium values were normal.|||
91488206|NCT05280782|182848444|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Chloride values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Chloride values were normal.|||
91488207|NCT05280782|182848444|EQUIVALENCE|A McNemar test was performed between baseline and post-injection CO2 values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
91488208|NCT05280782|182848445|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Glucose values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
91488209|NCT05280782|182848445|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Calcium values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
91488210|NCT05280782|182848445|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Creatinine values. The values were categorized as Normal or Abnormal.||||||0.453||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.453
91488211|NCT05280782|182848445|EQUIVALENCE|A McNemar test was performed between baseline and post-injection BUN values. The values were categorized as Normal or Abnormal.||||||0.125||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.125
91687177|NCT02933255|183266696|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
91687178|NCT02933255|183266696|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.016
91687179|NCT02933255|183266696|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
91687180|NCT02933255|183266696|OTHER|||||||0.38||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.38
91687181|NCT02933255|183266698|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.||||||0.064|||||||Wilcoxon Signed Rank Test|||||||0.064
91687182|NCT02933255|183266698|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.||||||0.001|||||||Wilcoxon Signed Rank Test|||||||0.001
91687183|NCT02933255|183266698|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.003
91687184|NCT02933255|183266698|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.003
91687185|NCT02933255|183266698|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
91687186|NCT02933255|183266698|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.004
91687187|NCT02933255|183266699|OTHER|||||||0.002||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.002
91720454|NCT04428151|183333770|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4181|TWO_SIDED|95.0|0.74|1.28||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.28|0.74|0.4181
91720455|NCT04428151|183333771|SUPERIORITY||Difference in Percentage|-6.5||||0.9266219|TWO_SIDED|95.0|-15.4|2.3|||Miettinen & Nurminen|One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0. The reported p-value is nominal.|Based on Miettinen \& Nurminen method stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||2.3|-15.4|0.9266219
91720456|NCT00392223|183333781|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.47||||||95.0|-2.48|1.54|||||Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.|||1.54|-2.48|
91720457|NCT00392223|183333785|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.87||||||95.0|-2.58|0.84|||||ANCOVA adjusted for baseline, center and treatment.|||0.84|-2.58|
91720458|NCT02908347|183333795|SUPERIORITY||Median Difference (Final Values)|0.64||||0.8785|TWO_SIDED|95.0|-2.09|3.36|||Wilcoxon (Mann-Whitney)|||||3.36|-2.09|0.8785
91720459|NCT02908347|183333798|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 30 - Day 29||||1
91720460|NCT02908347|183333798|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 29||||1
91720461|NCT02908347|183333798|SUPERIORITY|||||||0.5136|||||||Fisher Exact|||PASI 30 - Day 43||||0.5136
91720462|NCT02908347|183333798|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 43||||1
91720463|NCT05816070|183333806|NON_INFERIORITY|The non-inferiority margin is -10% based on the general standard of antibacterial drug. Non-inferiority is established when P\<0.05.||||||0.0137|||||||Chi-squared|||||||0.0137
91488212|NCT05280782|182848445|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Bilirubin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
91720464|NCT05516758|183333813|SUPERIORITY||Odds Ratio (OR)|1.88||||0.014|TWO_SIDED|95.0|1.14|3.11|||Regression, Logistic|||||3.11|1.14|0.014
91720465|NCT05516758|183333813|SUPERIORITY||Odds Ratio (OR)|1.53||||0.098|TWO_SIDED|95.0|0.92|2.52|||Regression, Logistic|||||2.52|0.92|0.098
91720466|NCT05516758|183333813|SUPERIORITY||Odds Ratio (OR)|1.21||||0.534|TWO_SIDED|95.0|0.66|2.23|||Regression, Logistic|||||2.23|0.66|0.534
91720467|NCT00402831|183333828|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||Measles difference||2.6|-2.5|
91720468|NCT00402831|183333828|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-3.0|3.3||||||Mumps difference||3.3|-3.0|
91720469|NCT00402831|183333828|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.3|4.1||||||Rubella difference||4.1|-2.3|
91488213|NCT05280782|182848446|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Protein values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Total Protein values were normal.|||
91488214|NCT05280782|182848446|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Albumin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
91488215|NCT05280782|182848447|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Alkaline Phosphatase values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Alkaline Phosphatase values were normal.|||
91720470|NCT00402831|183333828|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.1|4.1||||||Varicella||4.1|-2.1|
91720471|NCT02814526|183333852|SUPERIORITY||Mean Difference (Net)|0.078||||0.29|TWO_SIDED||||||Regression, Linear|||||||0.29
91720472|NCT02814526|183333853|SUPERIORITY||Mean Difference (Net)|0.031||||0.74|TWO_SIDED||||||Regression, Linear|||||||0.74
91720473|NCT02814526|183333854|SUPERIORITY||Mean Difference (Net)|-0.009447||||0.8284|TWO_SIDED||||||Regression, Linear|||||||0.8284
91720474|NCT02814526|183333855|SUPERIORITY||Mean Difference (Net)|-0.02024||||0.7086|TWO_SIDED||||||Regression, Linear|||||||0.7086
91687188|NCT02933255|183266699|OTHER|||||||0.042||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
91687189|NCT02933255|183266699|OTHER|||||||0.233||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.233
91687190|NCT02933255|183266699|OTHER|||||||0.052||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.052
91687191|NCT02933255|183266699|OTHER|||||||0.055||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.055
91687192|NCT02933255|183266699|OTHER|||||||0.203||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.203
91687193|NCT02933255|183266699|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
91687194|NCT02933255|183266699|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
91687195|NCT02933255|183266699|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
91687196|NCT02933255|183266699|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
91687197|NCT02933255|183266699|OTHER|||||||0.004||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
91687198|NCT02933255|183266699|OTHER|||||||0.129||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.129
91687199|NCT02933255|183266701|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
91687200|NCT02933255|183266701|OTHER|||||||0.037||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.037
91687201|NCT02933255|183266701|OTHER|||||||0.009||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.009
91687202|NCT02933255|183266701|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
91687203|NCT02933255|183266701|OTHER|||||||0.204||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.204
91488216|NCT05280782|182848447|EQUIVALENCE|A McNemar test was performed between baseline and post-injection ALT values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
91687204|NCT02933255|183266701|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
91687205|NCT02933255|183266701|OTHER|||||||0.042||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.042
91687206|NCT02933255|183266701|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
91488217|NCT05280782|182848447|EQUIVALENCE|A McNemar test was performed between baseline and post-injection AST values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the AST values were normal.|||
91687207|NCT02933255|183266701|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
91687208|NCT02933255|183266701|OTHER|||||||0.733||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
91687209|NCT02933255|183266701|OTHER|||||||0.519||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
91687210|NCT02933255|183266701|OTHER|||||||0.695||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.695
91687211|NCT02933255|183266701|OTHER|||||||0.034||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
91687212|NCT02933255|183266701|OTHER|||||||0.301||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.301
91720475|NCT02814526|183333856|SUPERIORITY||Mean Difference (Net)|0.29||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
91720476|NCT02814526|183333857|SUPERIORITY||Mean Difference (Net)|-0.17||||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
91488218|NCT05280782|182848448|EQUIVALENCE|A McNemar test was performed between baseline and post-injection WBC values. The values were categorized as Normal or Abnormal.||||||0.687||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.687
91687213|NCT02933255|183266701|OTHER|||||||0.38||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
91687214|NCT02933255|183266701|OTHER|||||||0.014||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.014
91687215|NCT02933255|183266701|OTHER|||||||0.791||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.791
91687216|NCT02933255|183266701|OTHER|||||||0.042||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
91687217|NCT02933255|183266701|OTHER|||||||0.424||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
91687218|NCT02933255|183266701|OTHER|||||||0.77||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.77
91687219|NCT02933255|183266701|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
91687220|NCT02933255|183266701|OTHER|||||||0.105||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
91687221|NCT02933255|183266701|OTHER|||||||0.622||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
91687222|NCT02933255|183266701|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
91687223|NCT02933255|183266701|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
91488219|NCT05280782|182848449|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hemoglobin values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
91687224|NCT02933255|183266701|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
91687225|NCT02933255|183266701|OTHER|||||||0.47||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.47
91687226|NCT02933255|183266701|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
91687227|NCT02933255|183266701|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
91687228|NCT02933255|183266701|OTHER|||||||0.092||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
91687229|NCT02933255|183266701|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
91687230|NCT02933255|183266701|OTHER|||||||0.232||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.232
91687231|NCT02933255|183266701|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
91687232|NCT02933255|183266701|OTHER|||||||0.131||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.131
91488220|NCT05280782|182848450|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hematocrit values. The values were categorized as Normal or Abnormal.||||||1||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||1.000
91687233|NCT02933255|183266701|OTHER|||||||0.424||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
91488221|NCT05280782|182848451|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Platelets values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Platelets values were normal.|||
91687234|NCT02933255|183266701|OTHER|||||||0.438||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.438
91687235|NCT02933255|183266701|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
91687236|NCT02933255|183266701|OTHER|||||||0.151||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.151
91720477|NCT02814526|183333858|SUPERIORITY||Mean Difference (Net)|-0.1||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
91488222|NCT05280782|182848452|EQUIVALENCE|A McNemar test was performed between baseline and post-injection RBC values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
91488223|NCT05280782|182848453|EQUIVALENCE|A McNemar test was performed between baseline and post-injection MCV values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the MCV values were normal.|||
91488224|NCT02761733|182848470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3652||||0.0679|TWO_SIDED|95.0|-6.9559|0.2255||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.2255|-6.9559|.0679
91488225|NCT02761733|182848470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.882||||0.0999|TWO_SIDED|95.0|-6.2957|0.5317||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||0.5317|-6.2957|.0999
91488226|NCT02761733|182848470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0139||||0.5588|TWO_SIDED|95.0|-4.4957|2.3779||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 148|||2.3779|-4.4957|.5588
91488227|NCT02761733|182848470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2798||||0.8532|TWO_SIDED|95.0|-2.6771|3.2367||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 136|||3.2367|-2.6771|.8532
91488228|NCT02761733|182848471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4524||||0.0988|TWO_SIDED|95.0|-7.5302|0.6254||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 180|||0.6254|-7.5302|.0988
91687237|NCT02933255|183266701|OTHER|||||||0.569||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.569
91488229|NCT02761733|182848471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3087||||0.876|TWO_SIDED|95.0|-4.1799|3.5625||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 166|||3.5625|-4.1799|.8760
91687238|NCT02933255|183266701|OTHER|||||||0.105||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
91687239|NCT02933255|183266701|OTHER|||||||0.012||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
91687240|NCT02933255|183266701|OTHER|||||||0.677||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.677
91687241|NCT02933255|183266701|OTHER|||||||0.424||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
91687242|NCT02933255|183266701|OTHER|||||||0.432||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.432
91687243|NCT02933255|183266701|OTHER|||||||0.016||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
91488230|NCT02761733|182848471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.541||||0.1878|TWO_SIDED|95.0|-1.2234|6.3054||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 153|||6.3054|-1.2234|.1878
91687244|NCT02933255|183266701|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
91687245|NCT02933255|183266701|OTHER|||||||0.519||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
91687246|NCT02933255|183266701|OTHER|||||||0.557||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.557
91687247|NCT02933255|183266701|OTHER|||||||0.034||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
91687248|NCT02933255|183266701|OTHER|||||||0.092||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
91720478|NCT02814526|183333859|SUPERIORITY||Mean Difference (Net)|-0.02||||0.61|TWO_SIDED||||||Regression, Linear|||||||0.61
91488231|NCT02761733|182848471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6237||||0.333|TWO_SIDED|95.0|-4.9|1.6526||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 143|||1.6526|-4.9000|.3330
91488232|NCT02761733|182848472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9284||||0.6588|TWO_SIDED|95.0|-10.4728|6.616||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 175|||6.6160|-10.4728|.6588
91488233|NCT02761733|182848472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3959||||0.2633|TWO_SIDED|95.0|-2.2237|11.0155||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 169||a priori test||11.0155|-2.2237|.2633
91488234|NCT02761733|182848472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9703||||0.0343|TWO_SIDED|95.0|-17.2107|-0.7299||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 166|Satterthwaite adjusted df = 166|a priori test||-0.7299|-17.2107|.0343
91488235|NCT02761733|182848472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7297||||0.3126|TWO_SIDED|95.0|-3.4864|10.9458||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis||Satterthwaite adjusted df = 163|a priori test||10.9458|-3.4864|.3126
91687249|NCT02933255|183266701|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.733
91687250|NCT02933255|183266701|OTHER|||||||0.922||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.922
91687251|NCT02933255|183266701|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
91687252|NCT02933255|183266701|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
91687253|NCT02933255|183266701|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
91687254|NCT02933255|183266701|OTHER|||||||0.563||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.563
91687255|NCT02933255|183266701|OTHER|||||||0.012||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
91687256|NCT02933255|183266701|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
91687257|NCT02933255|183266701|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
91687258|NCT02933255|183266701|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
91687259|NCT02933255|183266701|OTHER|||||||0.38||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
91687260|NCT02933255|183266701|OTHER|||||||0.021||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.021
91687261|NCT02933255|183266701|OTHER|||||||0.91||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.91
91687262|NCT02933255|183266701|OTHER|||||||0.084||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
91687263|NCT02933255|183266701|OTHER|||||||0.151||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.151
91687264|NCT02933255|183266701|OTHER|||||||0.042||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
91687265|NCT02933255|183266701|OTHER|||||||0.424||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
91687266|NCT02933255|183266701|OTHER|||||||0.846||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.846
91687267|NCT02933255|183266701|OTHER|||||||0.339||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
91687268|NCT02933255|183266701|OTHER|||||||0.012||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.012
91687269|NCT02933255|183266701|OTHER|||||||0.622||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
91687270|NCT02933255|183266701|OTHER|||||||0.492||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.492
91687271|NCT02933255|183266701|OTHER|||||||0.11||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.11
91687272|NCT02933255|183266701|OTHER|||||||0.02||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.02
91687273|NCT02933255|183266701|OTHER|||||||0.052||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.052
91687274|NCT02933255|183266701|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
91687275|NCT02933255|183266701|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||>0.999
91687276|NCT02933255|183266701|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
91687277|NCT02933255|183266701|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
91687278|NCT02933255|183266701|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||>0.999
91687279|NCT01579747|183266713|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Normality of distribution was assessed with the Shapiro-Wilk test. For normally-distributed continuous variables, the groups' distributions were described as means and standard deviations (SD). Student's t-test was used to compare groups in these cases with statistically-significant differences summarized using 95% confidence intervals as appropriate. For all comparisons, two-tailed p\<0.05 was considered statistically significant.||||<0.05
91687280|NCT02603146|183266772|OTHER||Cumulative Probability|0.336|||||TWO_SIDED|95.0|0.213|0.459|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for HCQ.|||0.459|0.213|
91687281|NCT02603146|183266772|OTHER||Cumulative Probability|0.394|||||TWO_SIDED|95.0|0.268|0.519|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for Placebo.|||0.519|0.268|
91687282|NCT02603146|183266772|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.058||||0.522|TWO_SIDED|95.0|-0.336|0.22||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.220|-0.336|0.522
91687283|NCT02603146|183266773|OTHER||Cumulative Probability|0.165|||||TWO_SIDED|95.0|0.076|0.225|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for HCQ.|||0.225|0.076|
91687284|NCT02603146|183266773|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for Placebo.|||0.289|0.099|
91687285|NCT02603146|183266773|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.029||||0.668|TWO_SIDED|95.0|-0.188|0.131||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.131|-0.188|0.668
91687286|NCT02603146|183266774|OTHER||Cumulative Probability|0.18|||||TWO_SIDED|95.0|0.088|0.273|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for HCQ.|||0.273|0.088|
91687287|NCT02603146|183266774|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for Placebo.|||0.289|0.099|
91687288|NCT02603146|183266774|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.014||||0.84|TWO_SIDED|95.0|-0.177|0.15||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.150|-0.177|0.840
91687289|NCT02603146|183266775|SUPERIORITY|||||||0.652|||||||Log Rank|||||||0.652
91687290|NCT02603146|183266776|OTHER||Cumulative Probability|0.356|||||TWO_SIDED|95.0|0.23|0.482|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for HCQ.|||0.482|0.230|
91687291|NCT02603146|183266776|OTHER||Cumulative Probability|0.425|||||TWO_SIDED|95.0|0.298|0.551|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for Placebo.|||0.551|0.298|
91687292|NCT02603146|183266776|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.069||||0.452|TWO_SIDED|95.0|-0.363|0.226||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.226|-0.363|0.452
91687293|NCT02603146|183266777|SUPERIORITY|||||||0.928||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.928
91687294|NCT02603146|183266777|SUPERIORITY|||||||0.076||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.076
91687295|NCT02603146|183266778|SUPERIORITY|||||||0.781||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.781
91687296|NCT02603146|183266778|SUPERIORITY|||||||0.457||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.457
91687297|NCT02603146|183266779|SUPERIORITY|||||||0.576||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.576
91687298|NCT02603146|183266779|SUPERIORITY|||||||0.323||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.323
91687299|NCT02603146|183266780|SUPERIORITY|||||||0.865||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.865
91687300|NCT02603146|183266780|SUPERIORITY|||||||0.179||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.179
91687301|NCT02603146|183266781|SUPERIORITY|||||||0.634||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.634
91687302|NCT02603146|183266781|SUPERIORITY|||||||0.574||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.574
91687303|NCT02603146|183266782|SUPERIORITY|||||||0.724||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.724
91687304|NCT02603146|183266782|SUPERIORITY|||||||0.149||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.149
91720479|NCT02814526|183333860|SUPERIORITY||Mean Difference (Net)|-0.01||||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
91720480|NCT02814526|183333861|SUPERIORITY||Mean Difference (Net)|-0.04||||0.31|TWO_SIDED||||||Regression, Linear|||||||0.31
91720481|NCT02814526|183333862|SUPERIORITY||Mean Difference (Net)|-0.0005||||0.817|TWO_SIDED||||||Regression, Linear|||||||0.817
91720482|NCT02814526|183333863|SUPERIORITY||Mean Difference (Net)|0.002||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
91720483|NCT02814526|183333864|SUPERIORITY||Mean Difference (Net)|-0.01||||0.97|TWO_SIDED||||||Regression, Linear|||||||0.97
91687305|NCT02603146|183266786|SUPERIORITY|||||||0.809|||||||Fisher Exact|||||||0.809
91687306|NCT06473519|183266792|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1month after vaccination. Null hypotheses(H0): RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided95%CI for GMT ratios (MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV A||1.10|0.84|
91687307|NCT06473519|183266792|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1 month after vaccination. Null hypotheses(H0):RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1 month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided 95%CI for GMT ratios(MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV B||1.06|0.79|
91687308|NCT05016960|183266802|OTHER|one group paired samples t test to compare scores at pre vs. post treatment||||||0.503|||||||t-test, 2 sided|||||||.503
91687309|NCT05016960|183266803|NON_INFERIORITY|one group paired samples t test||||||0.23|||||||t-test, 2 sided|||||||.230
91687310|NCT05016960|183266804|OTHER|one group paired samples t test||||||0.061|||||||t-test, 2 sided|||||||.061
91687311|NCT05016960|183266805|OTHER|one group paired samples t test|||||<|0.001|||||||t-test, 2 sided|||||||<.001
91720484|NCT02814526|183333865|SUPERIORITY||Mean Difference (Net)|-0.17||||0.94|TWO_SIDED||||||Regression, Linear|||||||0.94
91720485|NCT02485860|183333872|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
91720486|NCT03643848|183333925|SUPERIORITY||variance components; inferring mean diff|0.068|STANDARD_DEVIATION|0.033|<|0.046|TWO_SIDED|||||a priori threshold p\<.05|Mixed Models Analysis|REML; Satterwaite method for t-tests.Participant is random effect. Addtnl fixed effects: Valence, Condition, Anxiety Severity, Gender, Age (months).||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 1 week. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||<.046
91527660|NCT01976364|182930488|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.57|1.96||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.96|-1.57|
91687312|NCT05016960|183266806|OTHER|one group paired samples t test||||||0.01|||||||t-test, 2 sided|||||||.01
91687313|NCT05016960|183266807|OTHER|one group paired samples t test||||||0.625|||||||t-test, 2 sided|||||||.625
91687314|NCT05016960|183266808|OTHER|one group paired samples t test||||||0.134|||||||t-test, 2 sided|||||||.134
91687315|NCT05016960|183266809|OTHER|one group paired samples t test||||||0.515|||||||t-test, 2 sided|||||||.515
91687316|NCT05016960|183266810|OTHER|one group paired samples t test||||||0.41|||||||t-test, 2 sided|||||||.410
91687317|NCT05016960|183266811|OTHER|one group paired samples t test||||||0.706|||||||t-test, 2 sided|||||||.706
91687318|NCT05016960|183266812|OTHER|one group paired samples t test||||||0.062|||||||t-test, 2 sided|||||||.062
91687319|NCT05016960|183266813|OTHER|one group paired samples t test||||||0.39|||||||t-test, 2 sided|||||||.390
91687320|NCT05016960|183266814|OTHER|one group paired samples t test||||||0.38|||||||t-test, 2 sided|||||||.38
91720487|NCT03643848|183333926|SUPERIORITY||variance components; inferring mean diff|-0.033|STANDARD_ERROR_OF_MEAN|0.064|=|0.61|TWO_SIDED|||||a priori p\<.05|Mixed Models Analysis|included additional fixed effects: Anxiety severity, gender, age (months)||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 12 hour test. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||=.61
91720488|NCT04761822|183333927|SUPERIORITY||Risk Difference (RD)|0.026||||0.066|TWO_SIDED|95.0|-0.002|0.06||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.060|-0.002|0.066
91720489|NCT04761822|183333928|SUPERIORITY||Risk Difference (RD)|0.012||||0.267|TWO_SIDED|95.0|-0.016|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.016|0.267
91720490|NCT04761822|183333929|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
91720491|NCT04761822|183333930|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
91687321|NCT05016960|183266815|OTHER|One group paired samples t test||||||0.064|||||||t-test, 2 sided|||||||.064
91687322|NCT03713593|183266840|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.834|||||TWO_SIDED|95.0|0.712|0.978|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.978|0.712|
91687323|NCT03713593|183266841|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0227|TWO_SIDED|95.0|0.708|0.997|||Log Rank|Onesided p-value based on logrank test stratified by geographic region, portal vein invasion/extrahepatic spread/both AFP status,ECOG status.|Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.997|0.708|0.0227
91687324|NCT03713593|183266842|OTHER|Descriptive assessment|Difference in percentage|8.5|||||TWO_SIDED|95.0|2.8|14.2|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||14.2|2.8|
91687325|NCT03713593|183266845|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.93|0.66|
91687326|NCT03713593|183266846|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.68|0.94|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.94|0.68|
91687327|NCT03713593|183266847|OTHER|Descriptive assessment|Difference in percentage|6.7|||||TWO_SIDED|95.0|0.0|13.4|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||13.4|0.0|
91687328|NCT03713593|183266850|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.61|0.88|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.88|0.61|
91687329|NCT03620708|183266880|SUPERIORITY||chi-square|3.492|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91687330|NCT03620708|183266881|SUPERIORITY||chi-square|4.36||||0.113|TWO_SIDED||||||Chi-squared|||||||.113
91687331|NCT03620708|183266882|SUPERIORITY||Mean Difference (Final Values)|3.661||||0.032|TWO_SIDED||||||ANOVA|||||||.032
91687332|NCT03620708|183266883|SUPERIORITY||Mean Difference (Final Values)|1.543||||0.227|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of confidence in ability to quit.||||.227
91687333|NCT03620708|183266883|SUPERIORITY||Mean Difference (Final Values)|0.338||||0.715|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.||||.715
91687334|NCT03620708|183266883|SUPERIORITY||Mean Difference (Final Values)|1.712||||0.19|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.||||.190
91687335|NCT03620708|183266884|SUPERIORITY||Mean Difference (Final Values)|1.728||||0.188|TWO_SIDED||||||ANOVA|||||||.188
91687336|NCT03631199|183266949|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.62||||0.00164|TWO_SIDED|95.0|0.45|0.86|||Log Rank|||Chest pain||0.86|0.45|0.00164
91687337|NCT03631199|183266949|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.59||||0.00069|TWO_SIDED|95.0|0.43|0.82|||Log Rank|||Cough||0.82|0.43|0.00069
91687338|NCT03631199|183266949|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.66||||0.00045|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||Dyspnea||0.84|0.51|0.00045
91687339|NCT03631199|183266950|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.86||||0.113|TWO_SIDED|95.0|0.66|1.1|||Log Rank|||Quality of Life||1.10|0.66|0.113
91687340|NCT03631199|183266950|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.68||||0.00433|TWO_SIDED|95.0|0.51|0.91|||Log Rank|||Shortness of Breath||0.91|0.51|0.00433
91687341|NCT03631199|183266950|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.93||||0.294|TWO_SIDED|95.0|0.72|1.2|||Log Rank|||Pain||1.20|0.72|0.294
91687342|NCT03690388|183266954|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|96.0|0.13|0.36|||Log Rank|||||0.36|0.13|< 0.0001
91687343|NCT03041311|183266956|SUPERIORITY||||||<|0.0001|ONE_SIDED|95.0||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.||||<0.0001
91687344|NCT03041311|183266957|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline ANC count as a covariate, the stratification factors of ECOG performance status (0 to1 vs. 2) and brain metastases (Yes vs. No), and treatment as a fixed effect. The logarithm transformation of # of Induction cycles was included as an offset variable in the modeling.||||<0.0001
91687345|NCT03041311|183266958|SUPERIORITY|||||||0.0195||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|negative binomial regression|Hochberg-based gatekeeping procedure||||||0.0195
91720492|NCT04761822|183333931|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046|||Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
91488236|NCT02761733|182848473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1241||||0.584|TWO_SIDED|95.0|-0.5675|0.3193||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 142|||.3193|-.5675|.5840
91687346|NCT03041311|183266959|SUPERIORITY|||||||0.1335||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model. The model included baseline hemoglobin as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No) and treatment as a fixed effect. The logarithm transformation of the number of weeks on treatment was included as an offset variable in the model.||||0.1335
91687347|NCT03041311|183266960|SUPERIORITY|||||||0.0686||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline absolute neutrophil count as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect. The logarithm transformation of number of Induction cycles was included as an offset variable in the modeling.||||0.0686
91687348|NCT03041311|183266961|SUPERIORITY|For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.|Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.218||0.9942|TWO_SIDED|95.0|0.64|1.52||The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.|Log Rank|stratified log-rank test|The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).|||1.52|0.64|0.9942
91687349|NCT02604407|183266991|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-8.1|||<|0.001|TWO_SIDED|95.0|-11.7|-4.4|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 12.5 mg and Placebo.|||-4.4|-11.7|<0.001
91687350|NCT02604407|183266991|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-13.4|||<|0.001|TWO_SIDED|95.0|-17.1|-9.7|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 37.5 mg and Placebo.|||-9.7|-17.1|<0.001
91687351|NCT02964312|183267003|SUPERIORITY||Proportion|89.5|||||TWO_SIDED|95.0|83.5|93.9||||||The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level \>90%.||93.9|83.5|
91687352|NCT02964312|183267006|SUPERIORITY||||||<|0.001||||||P values are based on paired t-tests for change from baseline with p\<0.05 indicating significance.|t-test, 2 sided|||||||<0.001
91687353|NCT03127514|183267080|SUPERIORITY|||||||0.03||||||A two-tailed P value of 0.05 or less was considered to indicate statistical significance.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope||||||0.03
91687354|NCT05024747|183267096|OTHER||Ratio T/R|96.68|||||TWO_SIDED|90.0|90.0|103.85||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||103.85|90.00|
91687355|NCT05024747|183267097|OTHER||Ratio T/R|92.37|||||TWO_SIDED|90.0|85.45|99.84||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||99.84|85.45|
91687356|NCT05024747|183267098|OTHER||Ratio T/R|92.54|||||TWO_SIDED|90.0|85.63|100.01||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||100.01|85.63|
91687357|NCT05024747|183267099|OTHER||Hodges- Lehmann's median difference|-0.0192||||0.0833|TWO_SIDED|95.0|-0.0542|0.0044|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0044|-0.0542|0.0833
91687358|NCT05024747|183267100|OTHER||Hodges- Lehmann's median difference|-6.0||||0.0205|TWO_SIDED|95.0|-10.5|0.0|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0000|-10.5000|0.0205
91687359|NCT05024747|183267101|OTHER||Hodges- Lehmann's median difference|0.3225||||0.0946|TWO_SIDED|95.0|-0.0949|0.681|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.6810|-0.0949|0.0946
91687360|NCT01349192|183267141|SUPERIORITY||Proportion Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.25|0.74||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.74|0.25|0.0005
91687361|NCT01349192|183267141|SUPERIORITY||Proportion Difference (Final Values)|0.525||||0.0004|TWO_SIDED|95.0|0.23|0.8||Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.|||0.80|0.23|0.0004
91687362|NCT01349192|183267142|SUPERIORITY||Proportion Difference (Final Values)|0.09||||0.5463|TWO_SIDED|95.0|-0.18|0.34||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.34|-0.18|0.5463
91687363|NCT01349192|183267143|SUPERIORITY||Mean Difference (Final Values)|-9.42||||0.3683|TWO_SIDED|95.0|-30.3|11.47||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.|||11.47|-30.3|0.3683
91488237|NCT02761733|182848473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2642||||0.2404|TWO_SIDED|95.0|-0.1754|0.7038||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 184|||.7038|-.1754|.2404
91488238|NCT02761733|182848473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3192||||0.1074|TWO_SIDED|95.0|-0.0667|0.7051||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 129|||.7051|-.0667|.1074
91488239|NCT02761733|182848473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0576||||0.7677|TWO_SIDED|95.0|-0.3238|0.439||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 131|||.4390|-.3238|.7677
91687364|NCT01349192|183267144|SUPERIORITY||Proportion Difference (Final Values)|-0.2||||0.1205|TWO_SIDED|95.0|-0.42|0.03||The a priori threshold for statistical significance was 0.05.|Chi-squared||Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.03|-0.42|0.1205
91687365|NCT03749330|183267157|EQUIVALENCE|test of difference between pre and post|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91488240|NCT02761733|182848474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026||||0.9046|TWO_SIDED|95.0|-0.4507|0.3987||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 182|||.3987|-.4507|.9046
91488241|NCT02761733|182848474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2258||||0.2518|TWO_SIDED|95.0|-0.1591|0.6107||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.6107|-.1591|.2518
91488242|NCT02761733|182848474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.437||||0.0338|TWO_SIDED|95.0|-0.837|-0.037||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||-.0370|-.8370|.0338
91687366|NCT02023983|183267187|OTHER|||||||0.765|||||||Fisher Exact|||||||0.765
91687367|NCT02023983|183267188|OTHER|||||||1|||||||Fisher Exact|||||||1
91687368|NCT02105467|183267189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||One-sided, one-sample exact test|||Superiority of SVR12 in the Immediate Treatment group was tested against the historical response rate of 73%.||||<0.001
91720493|NCT04761822|183333932|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
91720494|NCT04761822|183333933|SUPERIORITY||Risk Difference (RD)|0.015||||0.4574|TWO_SIDED|95.0|-0.045|0.055||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.055|-0.045|0.4574
91488243|NCT02761733|182848474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2564||||0.1555|TWO_SIDED|95.0|-0.6086|0.0958||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 157|||.0958|-.6086|.1555
91687369|NCT02105467|183267190|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-10.8|9.6|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||9.6|-10.8|
91687370|NCT02105467|183267191|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.4|2.0|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||2.0|-4.4|
91488244|NCT02761733|182848475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2967||||0.0283|TWO_SIDED|95.0|-0.5599|-0.0335||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 213|||-.0335|-.5599|.0283
91687371|NCT01288807|183267224|OTHER|repeated measure ANOVA|||||<|0.01|||||||ANOVA|||||||< 0.01
91687372|NCT01288807|183267225|OTHER|two-tailed paired t-test|||||<|0.05|||||||t-test, 2 sided|||This analysis looks at the cold threshold measured in degrees celcius before and after treatment.||||< 0.05
91687373|NCT01288807|183267226|OTHER||||||>|0.05|||||||t-test, 2 sided|||This analysis looks at the pressure threshold measured in pounds per square inch before and after treatment||||> 0.05
91687374|NCT01288807|183267227|OTHER||||||>|0.05||||||one-way repeated measure ANOVA|ANOVA|||||||> 0.05
91687375|NCT03852537|183267248|SUPERIORITY|||||||0.494|||||||Fisher Exact|||||||0.494
91687376|NCT03852537|183267249|SUPERIORITY|||||||0.666|||||||Fisher Exact|||||||0.666
91687377|NCT03852537|183267250|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91687378|NCT03852537|183267252|SUPERIORITY|||||||0.477|||||||Fisher Exact|||||||0.477
91488245|NCT02761733|182848475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0401||||0.7407|TWO_SIDED|95.0|-0.1969|0.2771||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 194|||.2771|-.1969|.7407
91488246|NCT02761733|182848475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2338||||0.0619|TWO_SIDED|95.0|-0.4778|0.0102||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 186|||.0102|-.4778|.0619
91488247|NCT02761733|182848475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3793||||0.0009|TWO_SIDED|95.0|-0.599|-0.1596||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 172|||-.1596|-.5990|.0009
91687379|NCT03852537|183267253|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
91687380|NCT03852537|183267254|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91687381|NCT03852537|183267255|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
91687382|NCT03852537|183267256|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91687383|NCT03852537|183267258|SUPERIORITY|||||||0.213|||||||Chi-squared|||||||0.213
91687384|NCT05534061|183267260|SUPERIORITY||Odds Ratio (OR)|0.98||||0.944|TWO_SIDED|95.0|0.62|1.56||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.56|0.62|.944
91687385|NCT05534061|183267261|SUPERIORITY||Odds Ratio (OR)|1.01||||0.952|TWO_SIDED|95.0|0.62|1.65||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.65|0.62|.952
91687386|NCT05534061|183267262|SUPERIORITY||Odds Ratio (OR)|1.16||||0.768|TWO_SIDED|95.0|0.43|3.11||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||3.11|0.43|.768
91687387|NCT05534061|183267263|SUPERIORITY||Odds Ratio (OR)|3.96||||0.008|TWO_SIDED|95.0|1.43|10.94||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||10.94|1.43|.008
91687388|NCT00770328|183267274|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
91687389|NCT00770328|183267275|SUPERIORITY|||||||0.0114|||||||Wilcoxon (Mann-Whitney)|||||||0.0114
91687390|NCT01776632|183267278|SUPERIORITY||difference of adjusted means|0.15||||0.03|TWO_SIDED||||||generalized linear mixed effects|||||||.03
91687391|NCT01776632|183267279|SUPERIORITY||difference of adjusted means|0.39||||0.003|TWO_SIDED||||||generalized linear mixed effects|||||||.003
91687392|NCT01776632|183267280|SUPERIORITY||difference of adjusted means|-0.43||||0.04|TWO_SIDED||||||mixed effects models|||||||.04
91687393|NCT01776632|183267281|SUPERIORITY||difference of adjusted means|-1.27||||0.09|TWO_SIDED||||||mixed effects models|||||||.09
91687394|NCT04604795|183267342|OTHER||Ratio of geometric mean|1.05|||||TWO_SIDED|90.0|0.833|1.331|||||Log transformed Cmax was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.331|0.833|
91687395|NCT04604795|183267342|OTHER||Ratio of geometric mean|6.45|||||TWO_SIDED|90.0|4.916|8.474|||||Log transformed Cmax was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||8.474|4.916|
91687396|NCT04604795|183267351|OTHER||Ratio of geometric mean|1.53|||||TWO_SIDED|90.0|1.268|1.847|||||AUC(0-inf) was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.847|1.268|
91687397|NCT04604795|183267351|OTHER||Ratio of geometric mean|12.51|||||TWO_SIDED|90.0|10.141|15.423|||||Log transformed AUC(0-inf) was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||15.423|10.141|
91527661|NCT01976364|182930488|OTHER||LS mean difference|1.73|||||TWO_SIDED|95.0|-0.06|3.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.52|-0.06|
91687398|NCT04604795|183267388|OTHER||Ratio of geometric mean|0.47|||||TWO_SIDED|90.0|0.318|0.693|||||Day 5 (High fat meal) versus (vs) Day 3 (fasted)|||0.693|0.318|
91687399|NCT04604795|183267388|OTHER||Ratio of geometric mean|0.6|||||TWO_SIDED|90.0|0.405|0.882|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.882|0.405|
91687400|NCT04604795|183267388|OTHER||Ratio of geometric mean|0.29|||||TWO_SIDED|90.0|0.194|0.427|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.427|0.194|
91687401|NCT04604795|183267388|OTHER||Ratio of geometric mean|0.43|||||TWO_SIDED|90.0|0.292|0.643|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.643|0.292|
91687402|NCT04604795|183267388|OTHER||Ratio of geometric mean|0.42|||||TWO_SIDED|90.0|0.28|0.617|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.617|0.280|
91687403|NCT04604795|183267388|OTHER||Ratio of geometric mean|0.61|||||TWO_SIDED|90.0|0.41|0.903|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.903|0.410|
91687404|NCT04604795|183267390|OTHER||Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.867|1.205|||||Day 5 (High fat meal) vs Day 3 (fasted)|||1.205|0.867|
91687405|NCT04604795|183267390|OTHER||Ratio of geometric mean|1.11|||||TWO_SIDED|90.0|0.941|1.308|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.308|0.941|
91687406|NCT04604795|183267390|OTHER||Ratio of geometric mean|0.79|||||TWO_SIDED|90.0|0.671|0.933|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.933|0.671|
91687407|NCT04604795|183267390|OTHER||Ratio of geometric mean|0.85|||||TWO_SIDED|90.0|0.724|1.007|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.007|0.724|
91687408|NCT04604795|183267390|OTHER||Ratio of geometric mean|0.84|||||TWO_SIDED|90.0|0.713|0.992|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.992|0.713|
91687409|NCT04604795|183267390|OTHER||Ratio of geometric mean|0.99|||||TWO_SIDED|90.0|0.837|1.165|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.165|0.837|
91687410|NCT00174954|183267421|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||The a priori threshold for statistical significance was 0.05.|paired t-test|||||||0.785
91687411|NCT00174954|183267422|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The a priori threshold for statistical significance is 0.05.|paired t-test|||||||0.020
91687412|NCT00839254|183267423|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
91687413|NCT00839254|183267424|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
91488248|NCT00810693|182848482|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant||||<0.0001
91488249|NCT00810693|182848482|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.78|||<|0.0001|TWO_SIDED|95.0|20.06|51.51||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||51.51|20.06|<0.0001
91488250|NCT00810693|182848482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91488251|NCT00810693|182848483|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
91488252|NCT00810693|182848483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-225.72|||<|0.0001|TWO_SIDED|95.0|-281.37|-170.08||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-170.08|-281.37|<0.0001
91488253|NCT00810693|182848483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91488254|NCT00810693|182848484|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
91687414|NCT00509795|183267545|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.4|3.1|||||The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.||3.1|-4.4|
91687415|NCT00509795|183267545|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.1|-5.1|2.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||2.1|-5.1|
91692145|NCT01262872|183279148|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|-7.9|||||TWO_SIDED|95.0|-36.3|14.6||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||14.6|-36.3|
91488255|NCT00810693|182848484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-431.81||||0.0157|TWO_SIDED|95.0|-781.52|-82.1||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-82.10|-781.52|0.0157
91488256|NCT00810693|182848484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91488257|NCT00810693|182848485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0033||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0033
91488258|NCT00810693|182848486|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.2||||0.0046|TWO_SIDED|95.0|-9.85|-0.55||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region and therapy naive/add-on therapy|Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.|"The test is for difference of occurence of Any event."||-0.55|-9.85|0.0046
91527662|NCT01976364|182930489|OTHER||LS mean difference|0.71|||||TWO_SIDED|95.0|-1.01|2.42||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.42|-1.01|
91488259|NCT00810693|182848487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0022
91488260|NCT00810693|182848488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0663
91687416|NCT00509795|183267545|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.5|3.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||3.1|-4.5|
91687417|NCT00509795|183267546|SUPERIORITY_OR_OTHER||Differences in Least Squares means|3.15||||0.0054|TWO_SIDED|95.1|0.92|5.37||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||5.37|0.92|0.0054
91687418|NCT00509795|183267546|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.8||||0.4793|TWO_SIDED|95.1|-3.03|1.43||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.43|-3.03|0.4793
91687419|NCT00509795|183267546|SUPERIORITY_OR_OTHER||Differences in Least Squares Means|0.26||||0.8179|TWO_SIDED|95.1|-1.97|2.49||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||2.49|-1.97|0.8179
91687420|NCT00509795|183267547|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.1042|TWO_SIDED|95.1|-1.0|14.1||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The null hypothesis is that both percentages are equal.||14.1|-1.0|0.1042
91687421|NCT00509795|183267547|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.0||||0.1037|TWO_SIDED|95.1|-13.2|1.2||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The null hypothesis is that both percentages are equal.||1.2|-13.2|0.1037
91687422|NCT00509795|183267547|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.93|TWO_SIDED|95.1|-7.7|7.0||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.|The pairwise The null hypothesis is that both percentages are equal.||7.0|-7.7|0.93
91687423|NCT00509795|183267548|SUPERIORITY_OR_OTHER||Differences Least Squares means|1.28||||0.209|TWO_SIDED|95.1|-0.73|3.28||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||3.28|-0.73|0.2090
91488261|NCT00810693|182848488|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.0197|TWO_SIDED|95.0|0.01|0.11||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.11|0.01|0.0197
91488262|NCT00810693|182848488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91488263|NCT00810693|182848489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0019
91720495|NCT04761822|183333934|SUPERIORITY||Risk Difference (RD)|-0.016||||0.3242|TWO_SIDED|95.0|-0.086|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.086|0.3242
91720496|NCT04761822|183333935|SUPERIORITY||Risk Difference (RD)|0.024||||0.31|TWO_SIDED|95.0|-0.037|0.07||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.070|-0.037|0.3100
91720497|NCT04761822|183333936|SUPERIORITY||Risk Difference (RD)|-0.007||||0.807|TWO_SIDED|95.0|-0.0783|0.0366||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.0366|-0.0783|0.8070
91720498|NCT04761822|183333937|SUPERIORITY||Risk Difference (RD)|0.001||||1|TWO_SIDED|95.0|-0.04|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Pfizer-BioNTech COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.040|1.000
91720499|NCT04761822|183333938|SUPERIORITY||Risk Difference (RD)|-0.015||||0.25|TWO_SIDED|95.0|-0.053|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Moderna COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.053|0.250
91720500|NCT04761822|183333939|SUPERIORITY||Risk Difference (RD)|0.058||||0.004|TWO_SIDED|95.0|0.024|0.101||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.101|0.024|0.004
91720501|NCT04761822|183333940|SUPERIORITY||Risk Difference (RD)|0.075|||<|0.001|TWO_SIDED|95.0|0.039|0.124||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.124|0.039|<0.001
91720502|NCT00248560|183333953|SUPERIORITY_OR_OTHER||Response rate|0.17|||||TWO_SIDED|95.0|0.08|0.32||||||||0.32|0.08|
91720503|NCT03556683|183333959|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Effect immediately following hypertonic saline treatment.||||<0.001
91720504|NCT03556683|183333960|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||Effect of hypertonic saline 4 hours after treatment.||||0.99
91720505|NCT03286504|183333964|SUPERIORITY||proportion difference|0.05||||0.55|TWO_SIDED|95.0|-0.112|0.212|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.212|-0.112|0.55
91720506|NCT03286504|183333965|SUPERIORITY||proportion difference|0.033||||0.71|TWO_SIDED|95.0|-0.145|0.211|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.211|-0.145|0.71
91720507|NCT03286504|183333967|SUPERIORITY||proportion difference|-0.05||||0.65|TWO_SIDED|95.0|-0.269|0.169|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.169|-0.269|0.65
91720508|NCT03286504|183333968|SUPERIORITY||proportion difference|0.226||||0.04|TWO_SIDED|95.0|0.015|0.438|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.438|0.015|0.04
91720509|NCT03286504|183333969|SUPERIORITY||proportion difference|0.208||||0.03|TWO_SIDED|95.0|0.023|0.393|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm.|||0.393|0.023|0.03
91488264|NCT00810693|182848489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17||||0.0009|TWO_SIDED|95.0|-9.79|-2.54||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-2.54|-9.79|0.0009
91720510|NCT03320369|183334006|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91720511|NCT03813654|183334010|OTHER|Mixed model analysis with post-hoc tests.|Mean Difference (Final Values)|90.0|STANDARD_DEVIATION|68.7|<|0.05|TWO_SIDED|||||A priori threshold was \<0.05.|Mixed Models Analysis||This is the difference between the control and 8-h Free Sleep Group.|||||<0.05
91720512|NCT03813654|183334015|SUPERIORITY|||||||0.09||||||The groups had unequal variances, so we adjusted for unequal variances when doing the t-test. The a priori threshold for statistical significance was p\<0.05.|t-test, 1 sided|Adjusted for unequal variances between the two groups.||We compared the PVT taken at the start of the final night shift between Group B and those in Group C who slept in the morning and had complete data. Our hypothesis was that Group B would have faster RTs.||||0.09
91720513|NCT03104413|183334025|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
91720514|NCT03104413|183334025|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|< 0.001
91720515|NCT03104413|183334026|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|< 0.001
91720516|NCT03104413|183334026|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
91720517|NCT03104413|183334027|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|<0.001
91720518|NCT03104413|183334027|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
91720519|NCT03104413|183334028|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24.0|6.4|0.001
91720520|NCT03104413|183334028|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
91488265|NCT00810693|182848489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91488266|NCT02572609|182848490|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|113.56|STANDARD_DEVIATION|16.24||0.0082|TWO_SIDED|90.0|106.48|121.1|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||121.10|106.48|0.0082
91488267|NCT02572609|182848491|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the AUC0-t will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|119.61|STANDARD_DEVIATION|10.65||0.0438|TWO_SIDED|90.0|114.65|124.79|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||124.79|114.65|0.0438
91488268|NCT02345226|182848518|NON_INFERIORITY|A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-2.0|||||TWO_SIDED|95.001|-5.9|1.8|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.||1.8|-5.9|
91720521|NCT03104413|183334029|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
91720522|NCT03104413|183334029|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3.0|0.008
91720523|NCT03104413|183334030|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|< 0.001
91720524|NCT03104413|183334030|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
91720525|NCT03104413|183334031|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
91720526|NCT03104413|183334031|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
91720527|NCT03104413|183334032|SUPERIORITY||Adjusted Risk Difference|9.6||||0.01|TWO_SIDED|95.0|2.3|16.9|||Cochran-Mantel-Haenszel|||||16.9|2.3|0.010
91720528|NCT03104413|183334032|SUPERIORITY||Adjusted Risk Difference|8.2||||0.023|TWO_SIDED|95.0|1.1|15.3|||Cochran-Mantel-Haenszel|||||15.3|1.1|0.023
91720529|NCT03104413|183334033|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.5|21.5|||Cochran-Mantel-Haenszel|||||21.5|8.5|<0.001
91720530|NCT03104413|183334033|SUPERIORITY||Adjusted Risk Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.1|24.5|||Cochran-Mantel-Haenszel|||||24.5|11.1|<0.001
91488269|NCT02345226|182848518|SUPERIORITY|||||||0.35|||||||Fisher Exact|||||||0.35
91527663|NCT01976364|182930489|OTHER||LS mean difference|0.34|||||TWO_SIDED|95.0|-1.49|2.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.18|-1.49|
91720531|NCT03104413|183334034|SUPERIORITY||Adjusted Risk Difference|17.5|||<|0.001|TWO_SIDED|95.0|8.0|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.0|<0.001
91720532|NCT03104413|183334034|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|10.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|10.8|<0.001
91720533|NCT03104413|183334035|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.001|TWO_SIDED|95.0|12.1|31.6|||Cochran-Mantel-Haenszel|||||31.6|12.1|<0.001
91720534|NCT03104413|183334035|SUPERIORITY||Adjusted Risk Difference|22.7|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
91720535|NCT03104413|183334036|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
91720536|NCT03104413|183334036|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
91720537|NCT03104413|183334037|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4.0|0.006
91720538|NCT03104413|183334037|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
91720539|NCT03104413|183334038|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
91720540|NCT03104413|183334038|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
91720541|NCT03104413|183334039|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
91720542|NCT03104413|183334039|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
91720543|NCT03104413|183334040|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
91720544|NCT03104413|183334040|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
91720545|NCT03104413|183334041|SUPERIORITY||Risk Difference (RD)|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Chi-squared|||||-2.9|-13.2|0.002
91720546|NCT03104413|183334041|SUPERIORITY||Risk Difference (RD)|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Chi-squared|||||-4.2|-14.1|<0.001
91720547|NCT03104413|183334042|SUPERIORITY||Risk Difference (RD)|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Chi-squared|||||15.7|-28.1|1
91488270|NCT01848704|182848542|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||Mixed Models Analysis|||||1.35|0.07|0.03
91488271|NCT01848704|182848543|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.03|TWO_SIDED|95.0|-1.13|-0.05|||Mixed Models Analysis|||||-0.05|-1.13|0.03
91488272|NCT01848704|182848544|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.18|TWO_SIDED|95.0|-0.95|0.19|||Mixed Models Analysis|||||0.19|-0.95|0.18
91488273|NCT01848704|182848545|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.029|TWO_SIDED|95.0|0.08|1.47|||Mixed Models Analysis|||||1.47|0.08|0.029
91687424|NCT00509795|183267548|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.67||||0.5128|TWO_SIDED|95.1|-2.69|1.35||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.35|-2.69|0.5128
91687425|NCT00509795|183267548|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.6||||0.5579|TWO_SIDED|95.1|-2.61|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-2.61|0.5579
91488274|NCT01848704|182848546|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.061|TWO_SIDED|95.0|-0.03|1.31|||Mixed Models Analysis|||||1.31|-0.03|0.061
91488275|NCT01498978|182848565|OTHER|Exact binomial test (two-sided).||||||0.754|||||||Exact Binomial Test|||Exact binomial test (two-sided). Null hypothesis: the proportion is equal to 0.5||||0.754
91488276|NCT01498978|182848566|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.19|||||||Fisher Exact|||||||0.190
91488277|NCT01498978|182848569|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.5|||||||Fisher Exact|||||||0.500
91488278|NCT01498978|182848570|OTHER|Test of association (contingency) between the two kinds of classification.||||||1|||||||Fisher Exact|||||||1.000
91488279|NCT01498978|182848571|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.524|||||||Fisher Exact|||||||0.524
91488280|NCT03488355|182848578|SUPERIORITY||Risk Ratio (RR)|1.15||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
91687426|NCT00509795|183267549|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.33||||0.3575|TWO_SIDED|95.1|-1.04|0.38||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||0.38|-1.04|0.3575
91687427|NCT00509795|183267549|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.71||||0.0507|TWO_SIDED|95.1|-0.01|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-0.01|0.0507
91687428|NCT00509795|183267549|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.86||||0.0173|TWO_SIDED|95.1|0.15|1.58||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.58|0.15|0.0173
91687429|NCT02213289|183267606|SUPERIORITY|||||||0.0024|||||||One-sided Z-test|This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.||||||0.0024
91687430|NCT02687529|183267615|EQUIVALENCE|The number of positive and negative CST001 assay results for each subject, across all sites and operators were compared. In order for a subject to have a concordant result, the same assay call must be observed for all replicates across all sites (6/6).|proportion of concordant calls|83.33|||||TWO_SIDED|95.0|72.13|91.38||||||||91.38|72.13|
91687431|NCT06075277|183267618|OTHER||Ratios of adjusted geometric means [%]|126.64|||||TWO_SIDED|90.0|112.09|143.08|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.8|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||143.08|112.09|
91687432|NCT06075277|183267619|OTHER||Ratios of adjusted geometric means [%]|126.12|||||TWO_SIDED|90.0|106.34|149.58|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 27.9.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||149.58|106.34|
91687433|NCT06075277|183267620|OTHER||Ratios of adjusted geometric means [%]|126.04|||||TWO_SIDED|90.0|111.7|142.21|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.6.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||142.21|111.70|
91687434|NCT03300817|183267652|SUPERIORITY|||||||0.6834|||||||Wilcoxon Rank-Sum test|||||||0.6834
91687435|NCT03765788|183267765|SUPERIORITY||Odds Ratio (OR)|9.31|||||TWO_SIDED|95.0|3.54|26.29|||||Odd Ratio (posterior median) median and 95% credibility interval calculated using the Bayesian inference|Odds Ratio||26.29|3.54|
91687436|NCT03176134|183267802|OTHER||Estimated Difference|6.5|||||TWO_SIDED|95.0|-12.2|25.3|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||25.3|-12.2|
91489404|NCT02484690|182851583|SUPERIORITY||Difference in Least Squares Means|-0.96||||0.3189|TWO_SIDED|80.0|-2.2|0.28||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.28|-2.20|0.3189
91687437|NCT03176134|183267802|OTHER||Estimated Difference|-12.5|||||TWO_SIDED|95.0|-28.7|3.7|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||3.7|-28.7|
91687438|NCT03176134|183267802|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
91687439|NCT03176134|183267802|OTHER||Estimated Difference|1.3|||||TWO_SIDED|95.0|-10.7|13.4|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||13.4|-10.7|
91687440|NCT03176134|183267803|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
91687441|NCT03176134|183267803|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
91687442|NCT03176134|183267803|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
91687443|NCT03176134|183267803|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
91687444|NCT03915652|183267804|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.34|TWO_SIDED|95.0|-2.88|1.02|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and appointment nonadherence during the intervention was compared with the 12 months prior.||1.02|-2.88|0.34
91687445|NCT03915652|183267805|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.34|TWO_SIDED|95.0|-1.08|0.39|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and emergency department visits and hospitalizations during the intervention was compared with the 12 months prior.||0.39|-1.08|0.34
91687446|NCT03915652|183267806|SUPERIORITY||Mean Difference (Final Values)|0.59|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||t-test, 1 sided|One sided t-test of percent of needs remaining from 100%.||Wave 1 and Wave 2 were combined and the quality metric at the end of the 12-month intervention was compared to the metric from the start of the intervention.||0.73|0.45|<0.001
91687447|NCT03915652|183267807|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.51|TWO_SIDED|95.0|-19.8|34.8|||t-test, 2 sided|||||34.8|-19.8|0.51
91687448|NCT03915652|183267808|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.17|TWO_SIDED|95.0|-0.43|1.92|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared post to pre.||1.92|-0.43|0.17
91687449|NCT03915652|183267809|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.72|TWO_SIDED|95.0|-4.92|6.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared pre/post intervention||6.52|-4.92|0.72
91687450|NCT03915652|183267810|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.5|TWO_SIDED|95.0|-6.22|10.22|||t-test, 2 sided|||Waves 1 and 2 are combined; pre/post survey analysis||10.22|-6.22|0.50
91687451|NCT03915652|183267811|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.01|TWO_SIDED|95.0|1.06|6.47|||t-test, 2 sided|||Waves 1 and 2 combined; pre/post analysis||6.47|1.06|0.01
91687452|NCT03915652|183267812|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.77|TWO_SIDED|95.0|-1.27|0.98|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, pre/post test||0.98|-1.27|0.77
91720548|NCT03104413|183334042|SUPERIORITY||Risk Difference (RD)|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Chi-squared|||||60.2|0.6|0.113
91687453|NCT03915652|183267813|SUPERIORITY||Mean Difference (Final Values)|2.14||||0.37|TWO_SIDED|95.0|-3.23|7.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined; pre/post analysis||7.52|-3.23|0.37
91687454|NCT05736861|183267814|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.96|1.17|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.17|0.96|
91687455|NCT05736861|183267815|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.4|2.6|||||The interval is a highest-density credible interval. Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|||2.6|0.4|
91687456|NCT05736861|183267818|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.6|1.8|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.8|0.6|
91687457|NCT05736861|183267819|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.5|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.50|
91720549|NCT03104413|183334043|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
91720550|NCT03104413|183334043|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|<0.001
91488281|NCT01163266|182848593|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|1.151||0.058|TWO_SIDED|95.0|-4.45|0.08||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.08|-4.45|0.058
91488282|NCT01163266|182848593|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|1.161||0.002|TWO_SIDED|95.0|-5.92|-1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.35|-5.92|0.002
91488283|NCT01163266|182848594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.301|TWO_SIDED|95.0|0.796|2.093|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.093|0.796|0.301
91488284|NCT01163266|182848594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.639||||0.044|TWO_SIDED|95.0|1.013|2.652||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.652|1.013|0.044
91687458|NCT05736861|183267820|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.39|
91687459|NCT05736861|183267821|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.52|1.91|||||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|1.91|0.52|
91687460|NCT05736861|183267822|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.82|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.25|0.82|
91687461|NCT05736861|183267822|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.23|0.78|
91687462|NCT05736861|183267822|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.41|0.82|
91720551|NCT03104413|183334044|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
91488285|NCT01163266|182848595|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.129||0.119|TWO_SIDED|95.0|-0.45|0.05|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.05|-0.45|0.119
91687463|NCT05736861|183267822|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.57|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.01|0.57|
91687464|NCT05736861|183267823|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.92|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.32|0.92|
91687465|NCT05736861|183267823|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.22|0.83|
91687466|NCT05736861|183267823|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.83|
91687467|NCT05736861|183267823|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Day 90|Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|1.10|0.72|
91687468|NCT05736861|183267824|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.20|0.80|
91687469|NCT05736861|183267824|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.78|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.25|0.78|
91687470|NCT05736861|183267824|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.43|0.86|
91720552|NCT03104413|183334044|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3|0.008
91720553|NCT03104413|183334045|SUPERIORITY||Adjusted Risk Difference|9.2||||0.006|TWO_SIDED|95.0|2.6|15.7|||Cochran-Mantel-Haenszel|||||15.7|2.6|0.006
91488286|NCT01163266|182848595|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.129||0.024|TWO_SIDED|95.0|-0.55|-0.04|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.04|-0.55|0.024
91687471|NCT05736861|183267824|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.66|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.12|0.66|
91687472|NCT05736861|183267825|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.35|0.87|
91687473|NCT05736861|183267825|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.57|0.96|
91687474|NCT05736861|183267825|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.54|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.54|0.92|
91687475|NCT05736861|183267825|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.71|
91687476|NCT05736861|183267826|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.97|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.47|0.97|
91687477|NCT05736861|183267826|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.33|0.84|
91687478|NCT05736861|183267826|OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.95|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.55|0.95|
91687479|NCT05736861|183267826|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.19|0.73|
91687480|NCT05736861|183267827|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.86|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.26|0.86|
91687481|NCT05736861|183267827|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.85|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.85|
91687482|NCT05736861|183267827|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.85|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.34|0.85|
91687483|NCT05736861|183267827|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.28|0.80|
91687484|NCT05736861|183267828|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.88|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.27|0.88|
91687485|NCT05736861|183267828|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.79|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.14|0.79|
91720554|NCT03104413|183334045|SUPERIORITY||Adjusted Risk Difference|10.3||||0.002|TWO_SIDED|95.0|3.7|16.8|||Cochran-Mantel-Haenszel|||||16.8|3.7|0.002
91687486|NCT05736861|183267828|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.75|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.09|0.75|
91720555|NCT03104413|183334046|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|<0.001
91488287|NCT01163266|182848596|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29|STANDARD_ERROR_OF_MEAN|1.891||0.025|TWO_SIDED|95.0|-8.03|-0.56|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.||||-0.56|-8.03|0.025
91720556|NCT03104413|183334046|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
91720557|NCT03104413|183334047|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
91720558|NCT03104413|183334047|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
91720559|NCT03104413|183334048|SUPERIORITY||LS Mean Difference|12.4||||0.001|TWO_SIDED|95.0|5.0|19.8|||Mixed-Effect Model Repeat Measurement|||||19.8|5.0|0.001
91488288|NCT01163266|182848596|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.26|STANDARD_ERROR_OF_MEAN|1.852|<|0.001|TWO_SIDED|95.0|-10.92|-3.6|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-3.60|-10.92|<0.001
91488289|NCT01163266|182848597|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.665||||0.093|TWO_SIDED|95.0|0.918|3.018|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.018|0.918|0.093
91488290|NCT01163266|182848597|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.779||||0.059|TWO_SIDED|95.0|0.979|3.233|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.233|0.979|0.059
91488291|NCT01163266|182848598|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.042||0.183|TWO_SIDED|95.0|-3.44|0.66|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.66|-3.44|0.183
91527664|NCT01976364|182930489|OTHER||LS mean difference|-1.81|||||TWO_SIDED|95.0|-3.7|0.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.09|-3.70|
91687487|NCT05736861|183267828|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.93|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.36|0.93|
91687488|NCT05736861|183267829|SUPERIORITY||Difference in model estimate time unwell|-0.49|||||TWO_SIDED|95.0|-0.82|-0.15|||||The interval is a highest-density credible interval.|||-0.15|-0.82|
91687489|NCT05736861|183267830|SUPERIORITY||Difference in model estimated means|0.59|||||TWO_SIDED|95.0|0.18|0.99|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.99|0.18|
91687490|NCT01130532|183267855|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91687491|NCT01130532|183267855|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91687492|NCT01130532|183267856|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687493|NCT01130532|183267856|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687494|NCT01130532|183267857|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687495|NCT01130532|183267857|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687496|NCT01130532|183267858|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687497|NCT01130532|183267858|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687498|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|2.28|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687499|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|2.26|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687500|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687501|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.12|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687502|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|STANDARD_ERROR_OF_MEAN|3.53|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687503|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687504|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|32.7|STANDARD_ERROR_OF_MEAN|3.82|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687505|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687506|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|STANDARD_ERROR_OF_MEAN|3.78|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687507|NCT01130532|183267859|SUPERIORITY_OR_OTHER||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|3.75|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687508|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|2.49|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91720560|NCT03104413|183334048|SUPERIORITY||LS Mean Difference|15.0|||<|0.001|TWO_SIDED|95.0|7.7|22.4|||Mixed-Effect Model Repeat Measurement|||||22.4|7.7|<0.001
91720561|NCT03104413|183334049|SUPERIORITY||Adjusted Risk Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.1|20.7|||Cochran-Mantel-Haenszel|||||20.7|7.1|<0.001
91488292|NCT01163266|182848598|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.066||0.025|TWO_SIDED|95.0|-4.5|-0.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||-0.30|-4.50|0.025
91488293|NCT03181893|182848606|OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.183|<|0.0001|TWO_SIDED|90.0|-20.26|-9.37|||LANCOVA-P model|||||-9.37|-20.26|<0.0001
91488294|NCT03181893|182848623|OTHER||Least Squares Mean Difference|10.83|STANDARD_ERROR_OF_MEAN|10.274||0.1537|TWO_SIDED|90.0|-7.1|28.77|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 4||28.77|-7.10|0.1537
91488295|NCT03181893|182848623|OTHER||Least Squares Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|10.761||0.1312|TWO_SIDED|90.0|-6.29|31.29|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 8||31.29|-6.29|0.1312
91687509|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687510|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|2.36|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687511|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687512|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687513|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687514|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|2.54|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687515|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|28.7|STANDARD_ERROR_OF_MEAN|2.53|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687516|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.65|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687517|NCT01130532|183267860|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1|STANDARD_ERROR_OF_MEAN|2.64|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687518|NCT01130532|183267861|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9|STANDARD_ERROR_OF_MEAN|2.77|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
91488296|NCT03181893|182848623|OTHER||Least Squares Mean Difference|19.44|STANDARD_ERROR_OF_MEAN|12.161||0.0647|TWO_SIDED|90.0|-1.79|40.68|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 12||40.68|-1.79|0.0647
91488297|NCT01361568|182848641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|3.64|<|0.05|TWO_SIDED|95.0|-15.14|-0.78|||t-test, 2 sided|||||-0.78|-15.14|<0.05
91687519|NCT01130532|183267861|SUPERIORITY_OR_OTHER||LS Mean Difference|31.0|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
91687520|NCT01130532|183267862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687521|NCT01130532|183267862|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687522|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|2.81|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687523|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.78|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687524|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|22.3|STANDARD_ERROR_OF_MEAN|2.46|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687525|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687526|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|16.9|STANDARD_ERROR_OF_MEAN|2.37|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91720562|NCT03104413|183334049|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|10.3|24.2|||Cochran-Mantel-Haenszel|||||24.2|10.3|<0.001
91488298|NCT01361568|182848642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-420.0|STANDARD_ERROR_OF_MEAN|139.16|<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91488299|NCT01361568|182848642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-230.1|STANDARD_ERROR_OF_MEAN|92.26|<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91488300|NCT01361568|182848642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-260.4|STANDARD_ERROR_OF_MEAN|141.99||0.068||95.0|||||t-test, 2 sided|||||||0.068
91488301|NCT01361568|182848643|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.63|<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
91488302|NCT01361568|182848643|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|1.74||0.059||95.0|||||Mixed Models Analysis|||||||0.059
91488303|NCT01361568|182848644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.41|<|0.05|TWO_SIDED|95.0|0.22|1.82|||t-test, 2 sided|||||1.82|0.22|<0.05
91687527|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687528|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.57|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687529|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.56|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687530|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|2.88|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687531|NCT01130532|183267863|SUPERIORITY_OR_OTHER||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
91687532|NCT01130532|183267864|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
91687533|NCT01130532|183267864|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|STANDARD_ERROR_OF_MEAN|2.74|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
91687534|NCT01130532|183267866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
91720563|NCT03104413|183334050|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
91720564|NCT03104413|183334050|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
91720565|NCT03104413|183334051|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4|0.006
91720566|NCT03104413|183334051|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
91488304|NCT01361568|182848644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.11|1.17|||t-test, 2 sided|||||1.17|0.11|<0.05
91488305|NCT01361568|182848645|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Degrees of freedom (df = 1)||||||0.001
91687535|NCT01130532|183267866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
91488306|NCT01361568|182848646|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91488307|NCT01361568|182848647|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
91488308|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.80|1.24|
91687536|NCT01130532|183267866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
91687537|NCT01130532|183267867|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.002
91687538|NCT01130532|183267867|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.004
91687539|NCT01130532|183267867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
91687540|NCT04909853|183267884|OTHER||Ratio of Adjusted Geometric Means|129.78|||||TWO_SIDED|90.0|101.93|165.25|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||165.25|101.93|
91720567|NCT03104413|183334052|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
91720568|NCT03104413|183334052|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
91488309|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.15||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.15|0.78|
91720569|NCT03104413|183334053|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
91720570|NCT03104413|183334053|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
91720571|NCT03104413|183334054|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
91720572|NCT03104413|183334054|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
91720573|NCT03104413|183334055|SUPERIORITY||LS Mean Difference|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Mixed-Effect Model Repeat Measurement|||||-2.9|-13.2|0.002
91720574|NCT03104413|183334055|SUPERIORITY||LS Mean Difference|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Mixed-Effect Model Repeat Measurement|||||-4.2|-14.1|<0.001
91720575|NCT03104413|183334056|SUPERIORITY||LS Mean Difference|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Mixed-Effect Model Repeat Measurement|||||15.7|-28.1|1.00
91720576|NCT03104413|183334056|SUPERIORITY||LS Mean Difference|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Mixed-Effect Model Repeat Measurement|||||60.2|0.6|0.113
91720577|NCT03104413|183334057|SUPERIORITY||LS Mean Difference|-7.323||||0.113|TWO_SIDED|95.0|-16.399|1.753|||Mixed-Effect Model Repeat Measurement|||||1.753|-16.399|0.113
91720578|NCT03104413|183334057|SUPERIORITY||LS Mean Difference|-8.759||||0.05|TWO_SIDED|95.0|-17.518|-0.001|||Mixed-Effect Model Repeat Measurement|||||-0.001|-17.518|0.050
91720579|NCT03104413|183334058|SUPERIORITY||LS Mean Difference|2.221||||0.008|TWO_SIDED|95.0|0.577|3.865|||Mixed-Effect Model Repeat Measurement|||||3.865|0.577|0.008
91720580|NCT03104413|183334058|SUPERIORITY||LS Mean Difference|2.714||||0.001|TWO_SIDED|95.0|1.077|4.351|||Mixed-Effect Model Repeat Measurement|||||4.351|1.077|0.001
91488310|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.12||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.12|0.80|
91687541|NCT04909853|183267884|OTHER||Ratio of Adjusted Geometric Means|138.12|||||TWO_SIDED|90.0|113.18|168.55|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||168.55|113.18|
91687542|NCT04909853|183267884|OTHER||Ratio of Adjusted Geometric Means|148.02|||||TWO_SIDED|90.0|111.4|196.68|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||196.68|111.40|
91687543|NCT04909853|183267885|OTHER||Ratio of Adjusted Geometric Means|123.84|||||TWO_SIDED|90.0|99.64|153.91|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||153.91|99.64|
91720581|NCT03104413|183334059|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24|6.4|0.001
91687544|NCT04909853|183267885|OTHER||Ratio of Adjusted Geometric Means|187.4|||||TWO_SIDED|90.0|148.52|236.46|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||236.46|148.52|
91720582|NCT03104413|183334059|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
91488311|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.19|1.76||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.76|1.19|
91687545|NCT04909853|183267885|OTHER||Ratio of Adjusted Geometric Means|304.49|||||TWO_SIDED|90.0|237.6|390.21|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||390.21|237.60|
91720583|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.957|||||TWO_SIDED|95.0|0.903|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.|||0.986|0.903|
91720584|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.964|||||TWO_SIDED|95.0|0.908|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.986|0.908|
91720585|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.801|0.928|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.928|0.801|
91720586|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.892|||||TWO_SIDED|95.0|0.804|0.943|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.943|0.804|
91720587|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.839|||||TWO_SIDED|95.0|0.76|0.9|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.900|0.760|
91720588|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.776|0.933|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.933|0.776|
91720589|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.885|||||TWO_SIDED|95.0|0.811|0.937|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.937|0.811|
91720590|NCT01401166|183334061|SUPERIORITY_OR_OTHER||Estimated Proportion|0.911|||||TWO_SIDED|95.0|0.827|0.956|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.956|0.827|
91720591|NCT00297167|183334069|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-25.52|||<|0.001|TWO_SIDED|95.0|-31.73|-19.32|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-19.32|-31.73|<0.001
91720592|NCT00297167|183334070|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-26.85|-16.14|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-16.14|-26.85|<0.001
91720593|NCT02431299|183334140|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Whether there were significant changes in the IMRS baseline scores to IMRS follow up scores.|t-test, 2 sided|t = 2.78, df = 182||||||<0.01
91720594|NCT02431299|183334141|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.||||<0.05
91720595|NCT06178991|183334161|NON_INFERIORITY|The criterion for non-inferiority (NI) was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|1.38|||||TWO_SIDED|95.0|1.25|1.52|||||GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|H1N1||1.52|1.25|
91720596|NCT06178991|183334161|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|1.71|||||TWO_SIDED|95.0|1.58|1.86|||||GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|H3N2||1.86|1.58|
91720597|NCT06178991|183334161|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|0.66|||||TWO_SIDED|95.0|0.61|0.73|||||GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|Victoria||0.73|0.61|
91720598|NCT06178991|183334162|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroconversion was greater than -10%.|Difference in percentage of participants|17.9|||||TWO_SIDED|95.0|14.1|21.6|||||Difference in percentage of participants achieving seroconversion (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.|H1N1||21.6|14.1|
91720599|NCT06178991|183334162|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroconversion was greater than -10%.|Difference in percentage of participants|25.6|||||TWO_SIDED|95.0|21.7|29.3|||||Difference in percentage of participants achieving seroconversion (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.|H3N2||29.3|21.7|
91720600|NCT06178991|183334162|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroconversion was greater than -10%.|Difference in percentage of participants|-13.7|||||TWO_SIDED|95.0|-17.5|-10.0|||||Difference in percentage of participants achieving seroconversion (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.|Victoria||-10.0|-17.5|
91720601|NCT06178991|183334163|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|1.02|||||TWO_SIDED|95.0|0.94|1.1|||||GMRs (ratio of Arm C to Arm D titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|||1.10|0.94|
91720602|NCT06178991|183334164|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the difference in percentage of participants achieving seroresponse was greater than -10%.|Difference in percentage of participants|1.8|||||TWO_SIDED|95.0|-0.9|4.6|||||Difference in percentage of participants achieving seroresponse (Arm C - Arm D) and the associated 2-sided 95% CI was based on the Miettinen and Nurminen method. Data was expressed as percentages.|||4.6|-0.9|
91720603|NCT06178991|183334165|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|1.16|||||TWO_SIDED|95.0|1.01|1.34|||||GMRs (ratio of Arm E to Arm G titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|H1N1||1.34|1.01|
91720604|NCT06178991|183334165|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||GMRs (ratio of Arm E to Arm H titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|H1N1||1.11|0.85|
91720605|NCT06178991|183334165|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|1.75|||||TWO_SIDED|95.0|1.56|1.97|||||GMRs (ratio of Arm E to Arm G titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|H3N2||1.97|1.56|
91527092|NCT01672853|182929502|SUPERIORITY||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-2.3|1.6||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.6|-2.3|
91720606|NCT06178991|183334165|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|0.92|||||TWO_SIDED|95.0|0.82|1.03|||||GMRs (ratio of Arm E to Arm H titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|H3N2||1.03|0.82|
91720607|NCT06178991|183334165|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|0.58|||||TWO_SIDED|95.0|0.52|0.66|||||GMRs (ratio of Arm E to Arm G titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|Victoria||0.66|0.52|
91720608|NCT06178991|183334165|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|1.25|||||TWO_SIDED|95.0|1.11|1.4|||||GMRs (ratio of Arm E to Arm H titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|Victoria||1.40|1.11|
91720609|NCT06178991|183334166|NON_INFERIORITY|The criterion for NI was lower bounds of the 2-sided 95% CI for the GMR was greater than 0.67.|GMR|0.91|||||TWO_SIDED|95.0|0.82|1.01|||||GMRs (ratio of Arm E to Arm F titers) and 2-sided 95% CIs were calculated by exponentiating mean difference of the logarithms of the titers between the two comparative vaccine groups and the corresponding CIs (based on the Student t distribution).|||1.01|0.82|
91720610|NCT02273167|183334190|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|4.5||||0.055|ONE_SIDED|97.5|-4.0|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-4.00|0.055
91720611|NCT02273167|183334190|NON_INFERIORITY_OR_EQUIVALENCE|The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|1.59||||0.328|ONE_SIDED|97.5|-6.91|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-6.91|0.328
91720612|NCT02273167|183334191|NON_INFERIORITY_OR_EQUIVALENCE|Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|16.56|||<|0.001|ONE_SIDED|97.5|8.11|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||8.11|<0.001
91488312|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.86|0.59|
91488313|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.15|1.86||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.86|1.15|
91488314|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.97|1.42||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.42|0.97|
91488315|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.36|2.13||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||2.13|1.36|
91488316|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.48|0.67||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.67|0.48|
91488317|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.89||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.89|0.53|
91687546|NCT01783990|183267903|SUPERIORITY|||||||0.33|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.33
91687547|NCT01783990|183267904|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.80
91687548|NCT01783990|183267905|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.87
91687549|NCT01783990|183267906|SUPERIORITY|||||||0.28|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.28
91687550|NCT01783990|183267907|SUPERIORITY|||||||0.31|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.31
91687551|NCT01783990|183267908|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.04
91687552|NCT01038336|183267909|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|||||||0.289
91687553|NCT01038336|183267910|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
91687554|NCT01038336|183267911|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||ANOVA|||||||0.072
91687555|NCT01038336|183267912|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||||||0.030
91687556|NCT01038336|183267913|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||ANOVA|||||||0.092
91687557|NCT01038336|183267914|SUPERIORITY_OR_OTHER|||||||0.832|TWO_SIDED||||||ANOVA|||||||0.832
91687558|NCT01038336|183267915|SUPERIORITY_OR_OTHER|||||||0.454|TWO_SIDED||||||ANOVA|||||||0.454
91687559|NCT01038336|183267916|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||ANOVA|||||||0.128
91687560|NCT02366689|183267917|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.04
91687561|NCT02366689|183267918|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||< 0.001
91687562|NCT02366689|183267919|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91687563|NCT02366689|183267920|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.432
91687564|NCT02366689|183267921|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91687565|NCT02366689|183267922|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91687566|NCT03718832|183267923|SUPERIORITY||Mean Difference (Net)|-0.0333487|STANDARD_ERROR_OF_MEAN|0.1943638||0.8638688|TWO_SIDED|95.0|-0.415628|0.3489306||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.3489306|-0.415628|0.8638688
91687567|NCT03718832|183267923|SUPERIORITY||Mean Difference (Net)|-0.0066385|STANDARD_ERROR_OF_MEAN|0.1853917||0.9714571|TWO_SIDED|95.0|-0.371329|0.358052||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.358052|-0.371329|0.9714571
91687568|NCT03718832|183267924|SUPERIORITY||Mean Difference (Net)|0.1409446|STANDARD_ERROR_OF_MEAN|0.2106711||0.5039565|TWO_SIDED|95.0|-0.2735162|0.5554053||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.5554053|-0.2735162|0.5039565
91687569|NCT03718832|183267924|SUPERIORITY||Mean Difference (Net)|0.1213915|STANDARD_ERROR_OF_MEAN|0.2126328||0.5684854|TWO_SIDED|95.0|-0.2970052|0.5397882||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.5397882|-0.2970052|0.5684854
91720613|NCT02273167|183334191|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|18.74|||<|0.001|ONE_SIDED|97.5|10.32|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||10.32|<0.001
91488318|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|1.05|1.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.67|1.05|
91720614|NCT02273167|183334192|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
91720615|NCT02273167|183334192|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
91720616|NCT02273167|183334193|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-0.29||||0.569|TWO_SIDED|95.0|-8.74|8.02||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||8.02|-8.74|0.569
91488319|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.76|0.53|
91488320|NCT00761631|182848659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.28|0.91|
91488321|NCT01999868|182848664|SUPERIORITY|||||||0.41||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.||||0.41
91488322|NCT01999868|182848664|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.013
91527093|NCT01672853|182929502|SUPERIORITY||Difference in LS Mean|1.0|||||TWO_SIDED|95.0|-1.0|3.0||||||A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||3.0|-1.0|
91720617|NCT02273167|183334193|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|0.8||||0.455|TWO_SIDED|95.0|-7.65|9.11||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||9.11|-7.65|0.455
91720618|NCT02273167|183334194|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|7.1||||0.024|TWO_SIDED|95.0|-1.41|15.47|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||15.47|-1.41|0.024
91720619|NCT02273167|183334194|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.|Difference in PDR|2.37||||0.268|TWO_SIDED|95.0|-6.12|10.82||Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.|Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||10.82|-6.12|0.268
91720620|NCT02273167|183334195|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.|Difference in PDR|-0.49||||0.579|TWO_SIDED|95.0|-8.85|8.0|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||8.00|-8.85|0.579
91720621|NCT02273167|183334195|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|0.61||||0.478|TWO_SIDED|95.0|-7.78|9.09|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||9.09|-7.78|0.478
91720622|NCT03082729|183334201|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
91720623|NCT03082729|183334202|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
91720624|NCT03082729|183334203|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
91720625|NCT03082729|183334204|SUPERIORITY|||||||0.524|||||||t-test, 2 sided|||||||0.524
91527094|NCT02969525|182929506|OTHER||Correlation statistic|4.6|||=|0.031|||||||Cochran-Mantel-Haenszel|||"Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.~The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response."||||=0.031
91720626|NCT03082729|183334205|SUPERIORITY|||||||0.972|||||||t-test, 2 sided|||||||0.972
91720627|NCT03082729|183334206|SUPERIORITY|||||||0.315|||||||t-test, 2 sided|||||||0.315
91720628|NCT03082729|183334207|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||0.443
91720629|NCT03082729|183334208|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
91720630|NCT03082729|183334209|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.390
91720631|NCT03082729|183334210|SUPERIORITY|||||||0.116|||||||t-test, 2 sided|||||||0.116
91720632|NCT03082729|183334211|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
91720633|NCT03082729|183334212|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
91720634|NCT03082729|183334213|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
91720635|NCT03082729|183334214|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||||||0.882
91720636|NCT03082729|183334215|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
91720637|NCT03082729|183334216|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
91720638|NCT03082729|183334217|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
91720639|NCT03082729|183334218|SUPERIORITY|||||||0.771|||||||t-test, 2 sided|||||||0.771
91720640|NCT03082729|183334219|SUPERIORITY|||||||0.491|||||||t-test, 2 sided|||||||0.491
91720641|NCT03082729|183334220|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||||||0.924
91720642|NCT03082729|183334221|SUPERIORITY|||||||0.868|||||||t-test, 2 sided|||||||0.868
91720643|NCT03082729|183334222|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||||||0.922
91720644|NCT03082729|183334223|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
91720645|NCT03082729|183334224|SUPERIORITY|||||||0.453|||||||t-test, 2 sided|||||||0.453
91720646|NCT03082729|183334225|SUPERIORITY|||||||0.714|||||||t-test, 2 sided|||||||0.714
91720647|NCT03082729|183334226|SUPERIORITY|||||||0.434|||||||t-test, 2 sided|||||||0.434
91720648|NCT03082729|183334227|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
91488323|NCT01999868|182848664|SUPERIORITY|||||||0.5||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.50
91720649|NCT03082729|183334228|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||||||0.963
91488324|NCT01999868|182848664|SUPERIORITY|||||||0.67||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.67
91488325|NCT01999868|182848665|SUPERIORITY|||||||0.019||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.019
91488326|NCT01999868|182848665|SUPERIORITY|||||||0.001||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
91720650|NCT03082729|183334229|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.400
91720651|NCT03082729|183334230|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||||||0.223
91720652|NCT03082729|183334231|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
91720653|NCT03082729|183334232|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
91720654|NCT03082729|183334233|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
91488327|NCT01999868|182848665|SUPERIORITY|||||||0.018||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.018
91720655|NCT03082729|183334234|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
91720656|NCT03082729|183334235|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
91720657|NCT03082729|183334236|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
91720658|NCT03082729|183334237|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
91720659|NCT03082729|183334238|SUPERIORITY|||||||0.791|||||||t-test, 2 sided|||||||0.791
91720660|NCT03082729|183334239|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||||||0.925
91720661|NCT03082729|183334240|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
91720662|NCT03082729|183334241|SUPERIORITY|||||||0.546|||||||t-test, 2 sided|||||||0.546
91720663|NCT03082729|183334242|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
91720664|NCT03082729|183334243|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.840
91720665|NCT03082729|183334244|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||||||0.367
91720666|NCT03082729|183334245|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
91720667|NCT03082729|183334246|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
91720668|NCT03082729|183334247|SUPERIORITY|||||||0.953|||||||t-test, 2 sided|||||||0.953
91720669|NCT03082729|183334248|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||||||0.911
91720670|NCT03082729|183334249|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||||||0.944
91720671|NCT03082729|183334250|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
91720672|NCT03082729|183334251|SUPERIORITY|||||||0.988|||||||t-test, 2 sided|||||||0.988
91720673|NCT03082729|183334252|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
91720674|NCT03082729|183334253|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
91720675|NCT03082729|183334254|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||||||0.523
91720676|NCT03082729|183334255|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.060
91720677|NCT03082729|183334256|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
91720678|NCT03082729|183334257|SUPERIORITY|||||||0.946|||||||t-test, 2 sided|||||||0.946
91720679|NCT03082729|183334258|SUPERIORITY|||||||0.351|||||||t-test, 2 sided|||||||0.351
91720680|NCT03082729|183334259|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
91720681|NCT03082729|183334260|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||||||0.884
91720682|NCT03082729|183334261|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
91720683|NCT03082729|183334262|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91720684|NCT03082729|183334263|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
91720685|NCT03082729|183334264|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
91720686|NCT03082729|183334265|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
91720687|NCT03082729|183334266|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
91720688|NCT03082729|183334267|SUPERIORITY|||||||0.555|||||||t-test, 2 sided|||||||0.555
91720689|NCT03082729|183334268|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
91720690|NCT03082729|183334269|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
91720691|NCT03082729|183334270|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91720692|NCT03082729|183334270|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
91720693|NCT03082729|183334270|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|||||||0.537
91720694|NCT03082729|183334271|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91720695|NCT03082729|183334271|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
91720696|NCT03082729|183334271|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
91720697|NCT03082729|183334272|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91720698|NCT03082729|183334272|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91720699|NCT03082729|183334273|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91720700|NCT03082729|183334273|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91720701|NCT03082729|183334274|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91720702|NCT03082729|183334274|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91488328|NCT01999868|182848665|SUPERIORITY|||||||0.07||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.07
91488329|NCT01999868|182848666|SUPERIORITY|||||||0.16||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.16
91488330|NCT01999868|182848666|SUPERIORITY|||||||0.002||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.002
91488331|NCT01999868|182848666|SUPERIORITY|||||||0.23||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.23
91720703|NCT03082729|183334275|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91488332|NCT01999868|182848666|SUPERIORITY|||||||0.43||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.43
91488333|NCT01999868|182848667|SUPERIORITY|||||||0.06||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.06
91720704|NCT03082729|183334275|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91488334|NCT01999868|182848667|SUPERIORITY|||||||0.008||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.008
91488335|NCT01999868|182848668|SUPERIORITY|||||||0.005||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.005
91488336|NCT01999868|182848668|SUPERIORITY|||||||0.001||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
91720705|NCT03082729|183334277|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
91720706|NCT03082729|183334277|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||0.678
91720707|NCT03082729|183334278|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
91720708|NCT03082729|183334278|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||||||0.762
91720709|NCT03082729|183334279|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||||||0.973
91720710|NCT03082729|183334279|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||||||0.805
91720711|NCT03082729|183334280|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||||||0.951
91720712|NCT03082729|183334280|SUPERIORITY|||||||0.661|||||||t-test, 2 sided|||||||0.661
91720713|NCT03082729|183334281|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
91720714|NCT03082729|183334281|SUPERIORITY|||||||0.306|||||||t-test, 2 sided|||||||0.306
91720715|NCT03082729|183334282|SUPERIORITY|||||||0.322|||||||t-test, 2 sided|||||||0.322
91720716|NCT03082729|183334282|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
91720717|NCT03082729|183334283|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
91720718|NCT03082729|183334283|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||||||0.268
91720719|NCT03082729|183334284|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||||||0.501
91720720|NCT03082729|183334284|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
91720721|NCT03082729|183334285|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||||||0.259
91720722|NCT03082729|183334285|SUPERIORITY|||||||0.219|||||||t-test, 2 sided|||||||0.219
91720723|NCT03082729|183334286|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.140
91720724|NCT03082729|183334286|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
91720725|NCT03082729|183334287|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||||||0.302
91720726|NCT03082729|183334287|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
91720727|NCT03082729|183334288|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
91720728|NCT03082729|183334288|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
91720729|NCT03082729|183334289|SUPERIORITY|||||||0.812|||||||t-test, 2 sided|||||||0.812
91720730|NCT03082729|183334289|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
91720731|NCT03082729|183334290|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
91720732|NCT03082729|183334290|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.250
91720733|NCT03082729|183334291|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
91720734|NCT03082729|183334291|SUPERIORITY|||||||0.249|||||||t-test, 2 sided|||||||0.249
91720735|NCT03082729|183334292|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
91720736|NCT03082729|183334292|SUPERIORITY|||||||0.632|||||||t-test, 2 sided|||||||0.632
91720737|NCT03082729|183334293|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
91720738|NCT03082729|183334293|SUPERIORITY|||||||0.191|||||||t-test, 2 sided|||||||0.191
91720739|NCT03082729|183334294|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
91488337|NCT01999868|182848669|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40||||0.013
91488338|NCT01999868|182848669|SUPERIORITY|||||||0.95|||||||Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 88||||0.95
91488339|NCT01999868|182848670|SUPERIORITY|||||||0.18||||||Two-sided test.|ANCOVA|Randomization stratum (PASI score at week 0: 12-20 or \>20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.||Week 12 to 40||||0.18
91488340|NCT01999868|182848670|SUPERIORITY|||||||0.045||||||Two-sided test.|ANCOVA|Randomization (PASI score week 0:12-20 or \>20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates||Week 12 to 88||||0.045
91488341|NCT05938920|182848725|OTHER||Least Squares Mean|-0.6098|STANDARD_ERROR_OF_MEAN|1.78193|||TWO_SIDED|95.0|-4.1026|2.8831||||||||2.8831|-4.1026|
91720740|NCT03082729|183334294|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91720741|NCT03082729|183334295|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
91488342|NCT05938920|182848725|OTHER||Least Squares Mean|0.6721|STANDARD_ERROR_OF_MEAN|1.91075|||TWO_SIDED|95.0|-3.0738|4.4179||||||||4.4179|-3.0738|
91488343|NCT05938920|182848725|OTHER||Least Squares Mean|2.8232|STANDARD_ERROR_OF_MEAN|2.30479|||TWO_SIDED|95.0|-1.697|7.3433||||||||7.3433|-1.6970|
91488344|NCT05938920|182848725|OTHER||Least Squares Mean|-0.2933|STANDARD_ERROR_OF_MEAN|2.15954|||TWO_SIDED|95.0|-4.5273|3.9408||||||||3.9408|-4.5273|
91488345|NCT05938920|182848726|OTHER||Least Squares Mean|-0.0242|STANDARD_ERROR_OF_MEAN|0.04121|||TWO_SIDED|95.0|-0.105|0.0566||||||||0.0566|-0.1050|
91488346|NCT05938920|182848726|OTHER||Least Squares Mean|0.0194|STANDARD_ERROR_OF_MEAN|0.04492|||TWO_SIDED|95.0|-0.0687|0.1074||||||||0.1074|-0.0687|
91488347|NCT05938920|182848726|OTHER||Least Squares Mean|0.0892|STANDARD_ERROR_OF_MEAN|0.04994|||TWO_SIDED|95.0|-0.0087|0.1872||||||||0.1872|-0.0087|
91488348|NCT05938920|182848726|OTHER||Least Squares Mean|-0.0082|STANDARD_ERROR_OF_MEAN|0.04585|||TWO_SIDED|95.0|-0.0981|0.0817||||||||0.0817|-0.0981|
91488349|NCT05938920|182848727|OTHER||Least Squares Mean|-0.6043|STANDARD_ERROR_OF_MEAN|1.19916|||TWO_SIDED|95.0|-2.9549|1.7462||||||||1.7462|-2.9549|
91488350|NCT05938920|182848727|OTHER||Least Squares Mean|0.651|STANDARD_ERROR_OF_MEAN|1.33193|||TWO_SIDED|95.0|-1.9603|3.2624||||||||3.2624|-1.9603|
91488351|NCT05938920|182848727|OTHER||Least Squares Mean|2.4975|STANDARD_ERROR_OF_MEAN|1.43617|||TWO_SIDED|95.0|-0.3187|5.3136||||||||5.3136|-0.3187|
91488352|NCT05938920|182848727|OTHER||Least Squares Mean|-0.0209|STANDARD_ERROR_OF_MEAN|1.4247|||TWO_SIDED|95.0|-2.8142|2.7724||||||||2.7724|-2.8142|
91488353|NCT05938920|182848728|OTHER||Least Squares Mean|-0.5762|STANDARD_ERROR_OF_MEAN|1.74854|||TWO_SIDED|95.0|-4.0035|2.8511||||||||2.8511|-4.0035|
91488354|NCT05938920|182848728|OTHER||Least Squares Mean|0.5884|STANDARD_ERROR_OF_MEAN|1.90433|||TWO_SIDED|95.0|-3.1449|4.3216||||||||4.3216|-3.1449|
91720742|NCT03082729|183334295|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
91720743|NCT03082729|183334296|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
91488355|NCT05938920|182848728|OTHER||Least Squares Mean|2.6554|STANDARD_ERROR_OF_MEAN|2.2965|||TWO_SIDED|95.0|-1.8486|7.1593||||||||7.1593|-1.8486|
91488356|NCT05938920|182848728|OTHER||Least Squares Mean|-0.0625|STANDARD_ERROR_OF_MEAN|2.17274|||TWO_SIDED|95.0|-4.3227|4.1977||||||||4.1977|-4.3227|
91488357|NCT01251861|182848729|SUPERIORITY|||||||0.28||||||one-sided|Fisher Exact|||||||0.28
91720744|NCT03082729|183334296|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
91488358|NCT01251861|182848738|OTHER|The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.5||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||0.50
91488359|NCT01251861|182848739|OTHER|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.28||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||0.28
91488360|NCT03355365|182848755|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91488361|NCT03355365|182848756|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
91488362|NCT03355365|182848757|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91488363|NCT03355365|182848758|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91488364|NCT03355365|182848759|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||.43
91488365|NCT03355365|182848760|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91488366|NCT03355365|182848761|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91720745|NCT03082729|183334297|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||||||0.102
91720746|NCT03082729|183334297|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
91720747|NCT03082729|183334298|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
91720748|NCT03082729|183334298|SUPERIORITY|||||||0.222|||||||t-test, 2 sided|||||||0.222
91720749|NCT03082729|183334299|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||||||0.384
91720750|NCT03082729|183334299|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||0.112
91720751|NCT03082729|183334300|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
91720752|NCT03082729|183334300|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||||||0.896
91720753|NCT03082729|183334301|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
91720754|NCT03082729|183334301|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
91720755|NCT03082729|183334302|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.440
91720756|NCT03082729|183334302|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
91720757|NCT03082729|183334303|SUPERIORITY|||||||0.278|||||||t-test, 2 sided|||||||0.278
91720758|NCT03082729|183334303|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
91720759|NCT03082729|183334304|SUPERIORITY|||||||0.795|||||||t-test, 2 sided|||||||0.795
91720760|NCT03082729|183334304|SUPERIORITY|||||||0.284|||||||t-test, 2 sided|||||||0.284
91720761|NCT03082729|183334305|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.880
91720762|NCT03082729|183334305|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
91720763|NCT03082729|183334306|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||0.746
91720764|NCT03082729|183334306|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||0.199
91720765|NCT03082729|183334307|SUPERIORITY|||||||0.814|||||||t-test, 2 sided|||||||0.814
91720766|NCT03082729|183334307|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
91720767|NCT03082729|183334308|SUPERIORITY|||||||0.494|||||||t-test, 2 sided|||||||0.494
91720768|NCT03082729|183334308|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
91720769|NCT03082729|183334309|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
91488367|NCT03355365|182848762|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
91720770|NCT03082729|183334309|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
91720771|NCT03082729|183334310|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
91720772|NCT03082729|183334310|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||||||0.869
91720773|NCT03082729|183334311|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||||||0.977
91720774|NCT03082729|183334311|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
91720775|NCT03082729|183334312|SUPERIORITY|||||||0.591|||||||t-test, 2 sided|||||||0.591
91720776|NCT03082729|183334312|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
91720777|NCT03082729|183334313|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.260
91488368|NCT03355365|182848763|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91527665|NCT01976364|182930489|OTHER||LS mean difference|-1.76|||||TWO_SIDED|95.0|-3.99|0.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.48|-3.99|
91720778|NCT03082729|183334313|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
91720779|NCT03082729|183334314|SUPERIORITY|||||||0.545|||||||t-test, 2 sided|||||||0.545
91720780|NCT03082729|183334314|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.690
91720781|NCT03082729|183334315|SUPERIORITY|||||||0.542|||||||t-test, 2 sided|||||||0.542
91720782|NCT03082729|183334315|SUPERIORITY|||||||0.344|||||||t-test, 2 sided|||||||0.344
91720783|NCT03082729|183334316|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
91720784|NCT03082729|183334316|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91720785|NCT03082729|183334317|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
91720786|NCT03082729|183334317|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
91720787|NCT03082729|183334318|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91720788|NCT03082729|183334318|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
91720789|NCT03082729|183334319|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||||||0.392
91720790|NCT03082729|183334319|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||0.177
91720791|NCT03082729|183334320|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
91720792|NCT03082729|183334320|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
91720793|NCT03082729|183334321|SUPERIORITY|||||||0.421|||||||t-test, 2 sided|||||||0.421
91720794|NCT03082729|183334321|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
91720795|NCT03082729|183334322|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
91720796|NCT03082729|183334322|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
91720797|NCT03082729|183334323|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
91720798|NCT03082729|183334323|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
91720799|NCT03082729|183334324|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
91720800|NCT03082729|183334324|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
91720801|NCT03082729|183334325|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||||||0.362
91720802|NCT03082729|183334325|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
91720803|NCT03082729|183334326|SUPERIORITY|||||||0.813|||||||t-test, 2 sided|||||||0.813
91720804|NCT03082729|183334326|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91720805|NCT03082729|183334327|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||||||0.752
91720806|NCT03082729|183334327|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||||||0.808
91720807|NCT03082729|183334328|SUPERIORITY|||||||0.251|||||||t-test, 2 sided|||||||0.251
91720808|NCT03082729|183334328|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
91720809|NCT03082729|183334329|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||||||0.215
91720810|NCT03082729|183334329|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
91720811|NCT03082729|183334330|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||||||0.307
91720812|NCT03082729|183334330|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
91720813|NCT03082729|183334331|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||0.139
91720814|NCT03082729|183334331|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
91720815|NCT03082729|183334332|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
91720816|NCT03082729|183334332|SUPERIORITY|||||||0.285|||||||t-test, 2 sided|||||||0.285
91720817|NCT03082729|183334333|SUPERIORITY|||||||0.804|||||||t-test, 2 sided|||||||0.804
91720818|NCT03082729|183334333|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||||||0.793
91720819|NCT03082729|183334334|SUPERIORITY|||||||0.293|||||||t-test, 2 sided|||||||0.293
91720820|NCT03082729|183334334|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||||||0.355
91720821|NCT03082729|183334335|SUPERIORITY|||||||0.101|||||||t-test, 2 sided|||||||0.101
91720822|NCT03082729|183334335|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
91720823|NCT03082729|183334336|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
91720824|NCT03082729|183334336|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
91720825|NCT03082729|183334337|SUPERIORITY|||||||0.115|||||||t-test, 2 sided|||||||0.115
91720826|NCT03082729|183334337|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||0.378
91720827|NCT03082729|183334338|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
91720828|NCT03082729|183334338|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||||||0.815
91720829|NCT03082729|183334339|SUPERIORITY|||||||0.321|||||||t-test, 2 sided|||||||0.321
91720830|NCT03082729|183334339|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
91488369|NCT05203289|182848765|OTHER||Ratio of geometric means (%)|101.88|||||TWO_SIDED|90.0|93.31|111.23|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 105.455."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||111.23|93.31|
91687570|NCT03718832|183267925|SUPERIORITY||Mean Difference (Net)|-13.26835|STANDARD_ERROR_OF_MEAN|10.90353||0.2247426|TWO_SIDED|95.0|-34.73804|8.201347||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||8.201347|-34.73804|0.2247426
91687571|NCT03718832|183267925|SUPERIORITY||Mean Difference (Net)|-12.20164|STANDARD_ERROR_OF_MEAN|11.25555||0.2794015|TWO_SIDED|95.0|-34.37119|9.9679||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||9.9679|-34.37119|0.2794015
91687572|NCT03718832|183267925|SUPERIORITY||Mean Difference (Net)|13.12548|STANDARD_ERROR_OF_MEAN|9.550462||0.1708328|TWO_SIDED|95.0|-5.703702|31.95466||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||31.95466|-5.703702|0.1708328
91687573|NCT03718832|183267925|SUPERIORITY||Mean Difference (Net)|11.47577|STANDARD_ERROR_OF_MEAN|10.59479||0.2801138|TWO_SIDED|95.0|-9.422762|32.3743||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||32.3743|-9.422762|0.2801138
91687574|NCT03718832|183267926|SUPERIORITY||Mean Difference (Net)|-8.135585|STANDARD_ERROR_OF_MEAN|6.325031||0.1991028|TWO_SIDED|95.0|-20.57023|4.299061||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||4.299061|-20.57023|0.1991028
91687575|NCT03718832|183267926|SUPERIORITY||Mean Difference (Net)|3.493798|STANDARD_ERROR_OF_MEAN|1.761916||0.0480884|TWO_SIDED|95.0|0.0295297|6.958066||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||6.958066|0.0295297|0.0480884
91687576|NCT03718832|183267926|SUPERIORITY||Mean Difference (Net)|-9.681804|STANDARD_ERROR_OF_MEAN|6.34136||0.1276817|TWO_SIDED|95.0|-22.15188|2.788269||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.788269|-22.15188|0.1276817
91687577|NCT03718832|183267926|SUPERIORITY||Mean Difference (Net)|1.658257|STANDARD_ERROR_OF_MEAN|1.706497||0.3318554|TWO_SIDED|95.0|-1.698022|5.014535||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||5.014535|-1.698022|0.3318554
91687578|NCT03718832|183267927|SUPERIORITY||Mean Difference (Net)|-0.8749266|STANDARD_ERROR_OF_MEAN|0.9355095||0.3502313|TWO_SIDED|95.0|-2.714084|0.9642311||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.9642311|-2.714084|0.3502313
91687579|NCT03718832|183267927|SUPERIORITY||Mean Difference (Net)|0.5608222|STANDARD_ERROR_OF_MEAN|0.2708671||0.0390797|TWO_SIDED|95.0|0.0282451|1.093399||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.093399|0.0282451|0.0390797
91687580|NCT03718832|183267927|SUPERIORITY||Mean Difference (Net)|-1.450197|STANDARD_ERROR_OF_MEAN|0.9508997||0.1281032|TWO_SIDED|95.0|-3.320109|0.419716||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.419716|-3.320109|0.1281032
91687581|NCT03718832|183267927|SUPERIORITY||Mean Difference (Net)|0.2794625|STANDARD_ERROR_OF_MEAN|0.2717457||0.3044732|TWO_SIDED|95.0|-0.2549974|0.8139224||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.8139224|-0.2549974|0.3044732
91687582|NCT03718832|183267928|SUPERIORITY||Mean Difference (Net)|9.768353|STANDARD_ERROR_OF_MEAN|5.933945||0.1007463|TWO_SIDED|95.0|-1.907847|21.44455||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||21.44455|-1.907847|0.1007463
91720831|NCT03082729|183334340|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
91687583|NCT03718832|183267928|SUPERIORITY||Mean Difference (Net)|4.472004|STANDARD_ERROR_OF_MEAN|5.150772||0.3859868|TWO_SIDED|95.0|-5.66534|14.60935||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||14.60935|-5.66534|0.3859868
91720832|NCT03082729|183334340|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.180
91720833|NCT03082729|183334341|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
91720834|NCT03082729|183334341|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
91720835|NCT03082729|183334342|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
91720836|NCT03082729|183334342|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
91720837|NCT03082729|183334343|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
91720838|NCT03082729|183334343|SUPERIORITY|||||||0.208|||||||t-test, 2 sided|||||||0.208
91720839|NCT03082729|183334344|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|||||||0.446
91720840|NCT03082729|183334344|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
91720841|NCT03082729|183334345|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91720842|NCT03082729|183334345|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
91720843|NCT03353220|183334393|OTHER|||||||0.65||||||paired t test|t-test, 2 sided|||||||0.65
91720844|NCT03353220|183334394|OTHER|||||||0.0001||||||paired t test|t-test, 2 sided|||||||0.0001
91687584|NCT03718832|183267928|SUPERIORITY||Mean Difference (Net)|-0.5461143|STANDARD_ERROR_OF_MEAN|6.440905||0.9324908|TWO_SIDED|95.0|-13.22545|12.13323||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Unadjusted mean difference, 12 months after trial enrollment||12.13323|-13.22545|0.9324908
91687585|NCT03718832|183267928|SUPERIORITY||Mean Difference (Net)|-2.752831|STANDARD_ERROR_OF_MEAN|5.754947||0.6328075|TWO_SIDED|95.0|-14.08487|8.579205||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||8.579205|-14.08487|0.6328075
91687586|NCT03718832|183267929|SUPERIORITY||Mean Difference (Net)|8.352141|STANDARD_ERROR_OF_MEAN|4.663846||0.0743062|TWO_SIDED|95.0|-0.8250086|17.52929||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||17.52929|-0.8250086|0.0743062
91687587|NCT03718832|183267929|SUPERIORITY||Mean Difference (Net)|5.971188|STANDARD_ERROR_OF_MEAN|3.902349||0.1270654|TWO_SIDED|95.0|-1.709219|13.65159||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||13.65159|-1.709219|0.1270654
91687588|NCT03718832|183267929|SUPERIORITY||Mean Difference (Net)|2.637485|STANDARD_ERROR_OF_MEAN|4.443227||0.553277|TWO_SIDED|95.0|-6.110146|11.38512||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||11.38512|-6.110146|0.553277
91687589|NCT03718832|183267929|SUPERIORITY||Mean Difference (Net)|2.53149|STANDARD_ERROR_OF_MEAN|3.925307||0.519562|TWO_SIDED|95.0|-5.198658|10.26164||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||10.26164|-5.198658|0.519562
91687590|NCT03718832|183267930|SUPERIORITY||Mean Difference (Net)|-0.555117|STANDARD_ERROR_OF_MEAN|1.427417||0.6976216|TWO_SIDED|95.0|-3.363839|2.253605||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.253605|-3.363839|0.6976216
91687591|NCT03718832|183267930|SUPERIORITY||Mean Difference (Net)|-0.4977997|STANDARD_ERROR_OF_MEAN|1.041102||0.6329035|TWO_SIDED|95.0|-2.546815|1.551216||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.551216|-2.546815|0.6329035
91687592|NCT03718832|183267930|SUPERIORITY||Mean Difference (Net)|-1.386111|STANDARD_ERROR_OF_MEAN|1.812939||0.445181|TWO_SIDED|95.0|-4.954999|2.182777||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.182777|-4.954999|0.445181
91687593|NCT03718832|183267930|SUPERIORITY||Mean Difference (Net)|-1.101914|STANDARD_ERROR_OF_MEAN|1.860687||0.5542241|TWO_SIDED|95.0|-4.765783|2.561956||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||2.561956|-4.765783|0.5542241
91687594|NCT03718832|183267931|SUPERIORITY||Mean Difference (Net)|22.55812|STANDARD_ERROR_OF_MEAN|17.74244||0.2045348|TWO_SIDED|95.0|-12.35316|57.4694||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||57.4694|-12.35316|0.2045348
91687595|NCT03718832|183267931|SUPERIORITY||Mean Difference (Net)|13.49781|STANDARD_ERROR_OF_MEAN|14.95579||0.3675252|TWO_SIDED|95.0|-15.93658|42.9322||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||42.9322|-15.93658|0.3675252
91687596|NCT03718832|183267931|SUPERIORITY||Mean Difference (Net)|-11.35256|STANDARD_ERROR_OF_MEAN|26.69115||0.6709307|TWO_SIDED|95.0|-63.8992|41.19407||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||41.19407|-63.8992|0.6709307
91687597|NCT03718832|183267931|SUPERIORITY||Mean Difference (Net)|-8.912496|STANDARD_ERROR_OF_MEAN|21.34891||0.6766844|TWO_SIDED|95.0|-50.95358|33.12859||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||33.12859|-50.95358|0.6766844
91687598|NCT03718832|183267932|SUPERIORITY||Mean Difference (Net)|-1.870464|STANDARD_ERROR_OF_MEAN|2.024497||0.356123|TWO_SIDED|95.0|-5.851219|2.110291||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.110291|-5.851219|0.356123
91687599|NCT03718832|183267932|SUPERIORITY||Mean Difference (Net)|-0.8636408|STANDARD_ERROR_OF_MEAN|1.941141||0.6566494|TWO_SIDED|95.0|-4.681041|2.95376||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.95376|-4.681041|0.6566494
91527666|NCT01976364|182930489|OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-2.3|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-2.30|
91687600|NCT03718832|183267932|SUPERIORITY||Mean Difference (Net)|-3.772051|STANDARD_ERROR_OF_MEAN|1.905125||0.0484944|TWO_SIDED|95.0|-7.519021|-0.0250809||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0250809|-7.519021|0.0484944
91687601|NCT03718832|183267932|SUPERIORITY||Mean Difference (Net)|-2.167034|STANDARD_ERROR_OF_MEAN|1.821244||0.234947|TWO_SIDED|95.0|-5.749627|1.415558||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.415558|-5.749627|0.234947
91720845|NCT03353220|183334395|OTHER|||||||0.0017||||||paired t test|t-test, 2 sided|||||||0.0017
91488370|NCT05203289|182848766|OTHER||Ratio of geometric means (%)|105.38|||||TWO_SIDED|90.0|95.06|116.81|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 106.431."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||116.81|95.06|
91488371|NCT05203289|182848767|OTHER||Ratio of geometric means (%)|91.29|||||TWO_SIDED|90.0|84.38|98.76|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 104.874."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||98.76|84.38|
91488372|NCT01147640|182848826|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.4|||||TWO_SIDED|||||||||||||
91687602|NCT03718832|183267933|SUPERIORITY||Mean Difference (Net)|-0.5561156|STANDARD_ERROR_OF_MEAN|1.086759||0.6091477|TWO_SIDED|95.0|-2.693002|1.58077||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.58077|-2.693002|0.6091477
91687603|NCT03718832|183267933|SUPERIORITY||Mean Difference (Net)|-0.3787962|STANDARD_ERROR_OF_MEAN|1.032547||0.713942|TWO_SIDED|95.0|-2.409379|1.651786||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.651786|-2.409379|0.713942
91687604|NCT03718832|183267933|SUPERIORITY||Mean Difference (Net)|0.4989275|STANDARD_ERROR_OF_MEAN|1.053869||0.6362064|TWO_SIDED|95.0|-1.573807|2.571662||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.571662|-1.573807|0.6362064
91687605|NCT03718832|183267933|SUPERIORITY||Mean Difference (Net)|1.146286|STANDARD_ERROR_OF_MEAN|1.048105||0.2748884|TWO_SIDED|95.0|-0.9154561|3.208027||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3.208027|-0.9154561|0.2748884
91687606|NCT03718832|183267934|SUPERIORITY||Mean Difference (Net)|0.3232407|STANDARD_ERROR_OF_MEAN|0.3695066||0.3823224|TWO_SIDED|95.0|-0.4036366|1.050118||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.050118|-0.4036366|0.3823224
91687607|NCT03718832|183267934|SUPERIORITY||Mean Difference (Net)|0.2619965|STANDARD_ERROR_OF_MEAN|0.3729922||0.4829339|TWO_SIDED|95.0|-0.4718566|0.9958495||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.9958495|-0.4718566|0.4829339
91687608|NCT03718832|183267934|SUPERIORITY||Mean Difference (Net)|-0.6983982|STANDARD_ERROR_OF_MEAN|0.3476441||0.045506|TWO_SIDED|95.0|-1.382737|-0.0140597||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0140597|-1.382737|0.045506
91687609|NCT03718832|183267934|SUPERIORITY||Mean Difference (Net)|-0.6239824|STANDARD_ERROR_OF_MEAN|0.3336405||0.0625551|TWO_SIDED|95.0|-1.280906|0.0329412||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0329412|-1.280906|0.0625551
91687610|NCT03718832|183267935|SUPERIORITY||Mean Difference (Net)|2.276579|STANDARD_ERROR_OF_MEAN|1.636162||0.1650343|TWO_SIDED|95.0|-0.9420086|5.495166||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||5.495166|-0.9420086|0.1650343
91687611|NCT03718832|183267935|SUPERIORITY||Mean Difference (Net)|1.989458|STANDARD_ERROR_OF_MEAN|1.359013||0.1442126|TWO_SIDED|95.0|-0.6843682|4.663284||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||4.663284|-0.6843682|0.1442126
91687612|NCT03718832|183267935|SUPERIORITY||Mean Difference (Net)|-1.579811|STANDARD_ERROR_OF_MEAN|0.739612||0.0335498|TWO_SIDED|95.0|-3.03574|-0.1238828||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.1238828|-3.03574|0.0335498
91687613|NCT03718832|183267935|SUPERIORITY||Mean Difference (Net)|-1.764632|STANDARD_ERROR_OF_MEAN|0.8545352||0.0398937|TWO_SIDED|95.0|-3.447175|-0.0820899||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||-0.0820899|-3.447175|0.0398937
91687614|NCT03718832|183267936|SUPERIORITY||Mean Difference (Net)|-0.6294078|STANDARD_ERROR_OF_MEAN|0.4409795||0.1544491|TWO_SIDED|95.0|-1.496923|0.238107||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.238107|-1.496923|0.1544491
91687615|NCT03718832|183267936|SUPERIORITY||Mean Difference (Net)|-0.6081765|STANDARD_ERROR_OF_MEAN|0.451915||0.1793486|TWO_SIDED|95.0|-1.497352|0.2809987||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2809987|-1.497352|0.1793486
91687616|NCT03718832|183267936|SUPERIORITY||Mean Difference (Net)|-0.1731023|STANDARD_ERROR_OF_MEAN|0.4024787||0.6674618|TWO_SIDED|95.0|-0.9653829|0.6191784||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.6191784|-0.9653829|0.6674618
91720846|NCT03353220|183334399|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
91720847|NCT03857256|183334417|SUPERIORITY|Mean changes from Week 0 in LDL-C were analyzed using a restricted maximum likelihood (REML)-based repeated measures approach including effects of treatment group, time (Week 6 and Week 12) and treatment group x time interaction as well as the covariates of Week 0 value of LDL-C and Week 0 value of LDL-C x time interaction. An unstructured covariance structure were used to model the within-patient errors. Contrasts under this model allowed for the three main comparisons.||||||0.0167||||||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).|Mixed Models Analysis|The Kenward-Roger approximation were used to estimate denominator degrees of freedom.||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).||||0.0167
91720848|NCT00362232|183334460|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.71|||<|0.001||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.17|-5.25|<0.001
91720849|NCT00362232|183334460|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.71||||0.036||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences||Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.17|-5.25|0.036
91720850|NCT00362232|183334461|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.19||||0.012||95.0|-5.67|-0.71|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.71|-5.67|0.012
91488373|NCT01147640|182848827|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|95.0||||||||||||
91527667|NCT01976364|182930490|OTHER||LS mean difference|-0.68|||||TWO_SIDED|95.0|-2.05|0.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.69|-2.05|
91687617|NCT03718832|183267936|SUPERIORITY||Mean Difference (Net)|-0.2208031|STANDARD_ERROR_OF_MEAN|0.4196435||0.5992113|TWO_SIDED|95.0|-1.047063|0.6054567||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.6054567|-1.047063|0.5992113
91687618|NCT03718832|183267937|SUPERIORITY||Mean Difference (Net)|0.4824561|STANDARD_ERROR_OF_MEAN|0.423027||0.2549037|TWO_SIDED|95.0|-0.349686|1.314598||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.314598|-0.349686|0.2549037
91687619|NCT03718832|183267937|SUPERIORITY||Mean Difference (Net)|0.3545817|STANDARD_ERROR_OF_MEAN|0.4230741||0.4025977|TWO_SIDED|95.0|-0.4777863|1.186949||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.186949|-0.4777863|0.4025977
91687620|NCT03718832|183267937|SUPERIORITY||Mean Difference (Net)|-0.0102657|STANDARD_ERROR_OF_MEAN|0.4695747||0.9825739|TWO_SIDED|95.0|-0.9346107|0.9140792||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.9140792|-0.9346107|0.9825739
91687621|NCT03718832|183267937|SUPERIORITY||Mean Difference (Net)|-0.0340184|STANDARD_ERROR_OF_MEAN|0.4869778||0.9443607|TWO_SIDED|95.0|-0.9928399|0.9248032||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.9248032|-0.9928399|0.9443607
91687622|NCT03718832|183267938|SUPERIORITY||Mean Difference (Net)|0.160997|STANDARD_ERROR_OF_MEAN|0.0376773||2.52e-05|TWO_SIDED|95.0|0.0868814|0.2351126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.2351126|0.0868814|0.0000252
91720851|NCT00362232|183334462|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.456||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.6|-1.34|0.456
91720852|NCT00362232|183334462|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.37|||<|0.001||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.6|-1.34|<0.001
91720853|NCT00362232|183334463|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.124||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.22|-1.82|0.124
91720854|NCT00362232|183334463|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.8|||<|0.001||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.22|-1.82|<0.001
91488374|NCT00091442|182848828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5988||95.0|0.86|1.3||Not adjusted for multiple comparison.|Log Rank|||Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.||1.3|0.86|0.5988
91488375|NCT00091442|182848829|SUPERIORITY_OR_OTHER|||||||0.0085||95.0||||Not adjusted for multiple comparison|Cochran-Mantel-Haenszel|||Null hypothesis - no difference in response rate between the two treatment groups.||||0.0085
91488376|NCT00091442|182848830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001||95.0|0.55|0.77|||Log Rank|||"Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.~Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution."||0.77|0.55|<0.0001
91488377|NCT00986830|182848844|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value of \<0.05 was considered statistically significant.|t-test, 2 sided||||A reduction in SNOT-20 score of 0.8 or more is considered clinically meaningful.|||<0.0001
91488378|NCT00986830|182848845|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
91488379|NCT00986830|182848846|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
91488380|NCT00986830|182848847|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
91687623|NCT03718832|183267938|SUPERIORITY||Mean Difference (Net)|0.1691707|STANDARD_ERROR_OF_MEAN|0.0391132||2.04e-05|TWO_SIDED|95.0|0.0922183|0.2461232||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2461232|0.0922183|0.0000204
91687624|NCT03718832|183267938|SUPERIORITY||Mean Difference (Net)|0.0028595|STANDARD_ERROR_OF_MEAN|0.0261733||0.9130816|TWO_SIDED|95.0|-0.0486635|0.0543825||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0543825|-0.0486635|0.9130816
91687625|NCT03718832|183267938|SUPERIORITY||Mean Difference (Net)|0.0166325|STANDARD_ERROR_OF_MEAN|0.0271062||0.5400053|TWO_SIDED|95.0|-0.0367394|0.0700045||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0700045|-0.0367394|0.5400053
91687626|NCT03718832|183267939|SUPERIORITY||Mean Difference (Net)|0.0511555|STANDARD_ERROR_OF_MEAN|0.016316||0.0018721|TWO_SIDED|95.0|0.0190582|0.0832528||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0832528|0.0190582|0.0018721
91687627|NCT03718832|183267939|SUPERIORITY||Mean Difference (Net)|0.0433081|STANDARD_ERROR_OF_MEAN|0.0168497||0.0106231|TWO_SIDED|95.0|0.0101555|0.0764607||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0764607|0.0101555|0.0106231
91720855|NCT00362232|183334464|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.44||||||95.0|-1.59|0.66|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.66|-1.59|
91488381|NCT00986830|182848848|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
91488382|NCT00986830|182848849|SUPERIORITY|||||||0.009||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.009
91488383|NCT00986830|182848850|SUPERIORITY|||||||0.292||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.292
91488384|NCT00986830|182848851|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||<0.0001
91488385|NCT00850070|182848855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.35|||||||Chi-squared||Estimated value comparison was active treatment minus placebo.|Chi-square analyses were used to assess CGI-I scores. There were no transformations.||||<.35
91488386|NCT00850070|182848856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.06|||||||Chi-squared|||||||<0.06
91488387|NCT00850070|182848862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.05|||||||Mixed Models Analysis|||||||0.05
91488388|NCT00216476|182848874|SUPERIORITY_OR_OTHER||||||<|0.0001||||||threshold for significance: 0.05 (2-sided)|Log Rank|||Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).||||<0.0001
91687628|NCT03718832|183267939|SUPERIORITY||Mean Difference (Net)|0.0138256|STANDARD_ERROR_OF_MEAN|0.0171112||0.4197898|TWO_SIDED|95.0|-0.0198584|0.0475096||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0475096|-0.0198584|0.4197898
91720856|NCT00362232|183334465|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.72||||||95.0|-1.81|0.36|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.36|-1.81|
91720857|NCT00362232|183334466|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.38||||||95.0|-4.84|0.07|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.07|-4.84|
91720858|NCT00362232|183334467|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.67||||||95.0|-5.02|-0.32|||||Mantel-Haenszel weighted difference to Enoxaparin|||-0.32|-5.02|
91720859|NCT00362232|183334468|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.24||||||95.0|-0.22|0.71|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.71|-0.22|
91720860|NCT00362232|183334469|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||||95.0|-0.35|0.56||||||||0.56|-0.35|
91720861|NCT00362232|183334470|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||||95.0|-1.56|0.94|||||Exact methods for difference to Enoxaparin|||0.94|-1.56|
91720862|NCT00362232|183334471|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.47||||0.054||95.0|-4.99|0.04|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.04|-4.99|0.054
91720863|NCT00362232|183334471|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.47|||<|0.001||95.0|-4.49|0.04|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||0.04|-4.49|<0.001
91720864|NCT00362232|183334472|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.97||||0.017||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||-0.53|-5.42|0.017
91488389|NCT00216476|182848876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.0001
91720865|NCT00362232|183334472|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.97|||<|0.001||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.53|-5.42|<0.001
91527668|NCT01976364|182930490|OTHER||LS mean difference|-1.13|||||TWO_SIDED|95.0|-2.57|0.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.31|-2.57|
91720866|NCT00362232|183334473|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.27||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.44|-1.57|0.270
91720867|NCT00362232|183334473|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.57|||<|0.001||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.44|-1.57|<0.001
91720868|NCT00362232|183334474|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.98||||0.074||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.10|-2.06|0.074
91720869|NCT00362232|183334474|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .|Risk Difference (RD)|-0.98|||<|0.001||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.10|-2.06|<0.001
91720870|NCT00362232|183334475|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.39||||0.11||95.0|-0.09|0.88|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.88|-0.09|0.110
91720871|NCT02385318|183334497|EQUIVALENCE|85% power of success|Equivalence ratio|1.11|||||TWO_SIDED|90.0|-4.38|14.44|||Yates correction|||||14.44|-4.38|
91720872|NCT00300053|183334498|SUPERIORITY|||||||0.02|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.020
91720873|NCT00300053|183334498|SUPERIORITY|||||||0.035|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.035
91720874|NCT00300053|183334498|SUPERIORITY|||||||0.167|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.167
91720875|NCT00300053|183334498|SUPERIORITY|||||||0.181|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.181
91720876|NCT00300053|183334499|SUPERIORITY|||||||0.014|||||||ANCOVA|||Change from baseline to 6 months||||0.014
91720877|NCT00300053|183334499|SUPERIORITY|||||||0.017|||||||ANCOVA|||Change from baseline to 12 months||||0.017
91488390|NCT00216476|182848876|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
91720878|NCT00300053|183334499|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change from baseline to 6 months||||0.097
91488391|NCT00216476|182848876|SUPERIORITY_OR_OTHER|||||||0.1026|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||0.1026
91488392|NCT00216476|182848877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
91488393|NCT00216476|182848877|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
91488394|NCT00216476|182848877|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||0.0446
91488395|NCT00216476|182848878|SUPERIORITY_OR_OTHER|||||||0.0941|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.0941
91488396|NCT00216476|182848878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
91488397|NCT00216476|182848878|SUPERIORITY_OR_OTHER|||||||0.1146|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.1146
91527669|NCT01976364|182930490|OTHER||LS mean difference|-0.81|||||TWO_SIDED|95.0|-2.17|0.56||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.56|-2.17|
91720879|NCT00300053|183334499|SUPERIORITY|||||||0.134|||||||ANCOVA|||Change from baseline to 12 months||||0.134
91720880|NCT02594111|183334510|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91720881|NCT01431976|183334518|SUPERIORITY_OR_OTHER||percentage of participants|35.0|||||TWO_SIDED|95.0|15.39|59.22||||||||59.22|15.39|
91720882|NCT01126424|183334552|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-20.986||||0.3771|TWO_SIDED|95.0|-68.58|26.607|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||26.607|-68.580|0.3771
91720883|NCT01126424|183334552|SUPERIORITY_OR_OTHER||Least Square Mean Difference|17.508||||0.4487|TWO_SIDED|95.0|-28.854|63.87|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||63.870|-28.854|0.4487
91488398|NCT00216476|182848878|SUPERIORITY_OR_OTHER|||||||0.5589|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||0.5589
91488399|NCT00216476|182848878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
91488400|NCT00216476|182848878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
91488401|NCT00694707|182848954|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.5||||0.0005|TWO_SIDED|95.0|-11.8|-3.3|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-3.3|-11.8|0.0005
91488402|NCT00694707|182848954|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.8|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-4.6|-13.1|<0.0001
91488403|NCT00694707|182848954|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.6|-6.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-6.2|-14.6|<0.0001
91488404|NCT00694707|182848954|SUPERIORITY_OR_OTHER||Least squares mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-10.8|-19.4|<0.0001
91488405|NCT00694707|182848955|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.4||||0.004|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.1|-0.6|0.0040
91488406|NCT00694707|182848955|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.5||||0.0003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.2|-0.7|0.0003
91488407|NCT00694707|182848955|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.4|-0.9|<0.0001
91720884|NCT01126424|183334553|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.152||||0.0505|TWO_SIDED|95.0|-0.023|18.326|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||18.326|-0.023|0.0505
91720885|NCT01126424|183334553|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.846||||0.6753|TWO_SIDED|95.0|-7.02|10.713|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||10.713|-7.020|0.6753
91720886|NCT01126424|183334554|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.507||||0.5684|TWO_SIDED|95.0|-2.293|1.279|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||1.279|-2.293|0.5684
91720887|NCT01126424|183334554|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.792||||0.2348|TWO_SIDED|95.0|-2.122|0.538|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.538|-2.122|0.2348
91720888|NCT01126424|183334555|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.04||||0.6275|TWO_SIDED|95.0|-0.208|0.127|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.127|-0.208|0.6275
91720889|NCT01126424|183334555|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.046||||0.5361|TWO_SIDED|95.0|-0.194|0.103|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.103|-0.194|0.5361
91687629|NCT03718832|183267939|SUPERIORITY||Mean Difference (Net)|0.0179852|STANDARD_ERROR_OF_MEAN|0.0171811||0.2961479|TWO_SIDED|95.0|-0.0158442|0.0518147||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0518147|-0.0158442|0.2961479
91687630|NCT03718832|183267940|SUPERIORITY||Mean Difference (Net)|0.4018522|STANDARD_ERROR_OF_MEAN|0.1001575||7.43e-05|TWO_SIDED|95.0|0.2048311|0.5988733||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.5988733|0.2048311|0.0000743
91687631|NCT03718832|183267940|SUPERIORITY||Mean Difference (Net)|0.3643095|STANDARD_ERROR_OF_MEAN|0.1026922||0.0004471|TWO_SIDED|95.0|0.16227|0.566349||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.566349|0.16227|0.0004471
91687632|NCT03718832|183267940|SUPERIORITY||Mean Difference (Net)|0.0006229|STANDARD_ERROR_OF_MEAN|0.1095781||0.9954683|TWO_SIDED|95.0|-0.2150785|0.2163243||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2163243|-0.2150785|0.9954683
91687633|NCT03718832|183267940|SUPERIORITY||Mean Difference (Net)|-0.0161147|STANDARD_ERROR_OF_MEAN|0.1115322||0.8852268|TWO_SIDED|95.0|-0.2357129|0.2034834||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2034834|-0.2357129|0.8852268
91720890|NCT01126424|183334556|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.655||||0.6315|TWO_SIDED|95.0|-14.858|24.167|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||24.167|-14.858|0.6315
91687634|NCT03718832|183267941|SUPERIORITY||Mean Difference (Net)|0.9013876|STANDARD_ERROR_OF_MEAN|0.4414753||0.0417413|TWO_SIDED|95.0|0.0338441|1.768931||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.768931|0.0338441|0.0417413
91687635|NCT03718832|183267941|SUPERIORITY||Mean Difference (Net)|0.8939751|STANDARD_ERROR_OF_MEAN|0.3896126||0.0222222|TWO_SIDED|95.0|0.1282798|1.65967||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.65967|0.1282798|0.0222222
91687636|NCT03718832|183267941|SUPERIORITY||Mean Difference (Net)|0.0276596|STANDARD_ERROR_OF_MEAN|0.7606961||0.9710103|TWO_SIDED|95.0|-1.467185|1.522504||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1.522504|-1.467185|0.9710103
91720891|NCT01126424|183334556|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.457||||0.867|TWO_SIDED|95.0|-18.976|16.062|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||16.062|-18.976|0.8670
91720892|NCT01126424|183334557|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-77.919||||0.5953|TWO_SIDED|95.0|-372.814|216.976|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||216.976|-372.814|0.5953
91720893|NCT01126424|183334557|SUPERIORITY_OR_OTHER||Least Square Mean Difference|157.783||||0.3526|TWO_SIDED|95.0|-182.015|497.581|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||497.581|-182.015|0.3526
91720894|NCT02127671|183334558|SUPERIORITY||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-22.9|-2.5||||||||-2.5|-22.9|
91720895|NCT02127671|183334560|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.9||||||||0.9|-0.7|
91720896|NCT02127671|183334564|SUPERIORITY||Mean Difference (Net)|-7.6|||||TWO_SIDED|95.0|-17.6|2.4||||||||2.4|-17.6|
91720897|NCT02127671|183334565|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||||0.2|-0.3|
91720898|NCT02127671|183334566|SUPERIORITY||Mean Difference (Net)|-10.5|||||TWO_SIDED|95.0|-18.4|-2.6||||||||-2.6|-18.4|
91720899|NCT02127671|183334567|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-5.1|1.5||||||systolic||1.5|-5.1|
91720900|NCT02127671|183334567|SUPERIORITY||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.8|0.5||||||diastolic||0.5|-3.8|
91720901|NCT02127671|183334569|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-13.3|4.7||||||||4.7|-13.3|
91720902|NCT02127671|183334570|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-12.7|2.0||||||||2.0|-12.7|
91720903|NCT02127671|183334571|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.8|3.8||||||||3.8|-1.8|
91720904|NCT02127671|183334572|SUPERIORITY||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-13.4|29.6||||||||29.6|-13.4|
91720905|NCT00782067|183334580|OTHER|Single arm study|||||<|0.001|TWO_SIDED|95.0||||Null hypothesis: ORR \<= 30% Alternative hypothesis: ORR \>= 50%|Exact Binomial Test||||Exact Binomial 95% Confidence Interval|||<0.001
91720906|NCT00614393|183334601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.06|TWO_SIDED|95.0|0.99|2.0|||Regression, Cox|||||2.00|0.99|0.06
91720907|NCT00614393|183334601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.18|TWO_SIDED|95.0|0.89|1.79|||Regression, Cox|||||1.79|0.89|0.18
91720908|NCT00614393|183334602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.07|TWO_SIDED|95.0|0.98|1.83|||Regression, Cox|||||1.83|0.98|0.07
91720909|NCT00614393|183334602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.44|TWO_SIDED|95.0|0.83|1.55|||Regression, Cox|||||1.55|0.83|0.44
91720910|NCT02328105|183334608|SUPERIORITY|Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.|Response Rate|0.364||||0.161|TWO_SIDED|95.0|0.109|0.692||This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.692|0.109|0.161
91720911|NCT02328105|183334609|OTHER|Estimation only.|Disease Control Rate|0.818|||||TWO_SIDED|95.0|0.482|0.977|||||Confidence interval estimated using the Clopper Pearson method.|||0.977|0.482|
91720912|NCT02328105|183334610|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|2.2|13.0|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||13.0|2.2|
91720913|NCT02328105|183334611|OTHER|Estimation only.|Median|30.0|||||TWO_SIDED|95.0|2.2||Upper limit of the confidence interval is not reached due to censoring rate.||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||2.2|
91720914|NCT02328105|183334612|OTHER|Estimation only.|Median|10.8|||||TWO_SIDED|95.0|4.9|11.9|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||11.9|4.9|
91488408|NCT00694707|182848955|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.6|-1.1|<0.0001
91720915|NCT02328105|183334613|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|3.0|13.0|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median disease control duration.|||13.0|3.0|
91720916|NCT01013753|183334649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.097|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.182|0.097|<0.0001
91720917|NCT01013753|183334649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.14|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.224|0.140|<0.0001
91720918|NCT01013753|183334649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.163|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.248|0.163|<0.0001
91720919|NCT01013753|183334649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.186|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.272|0.186|<0.0001
91720920|NCT01013753|183334649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.126|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.126|<0.0001
91720921|NCT01013753|183334650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.116|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.211|0.116|<0.0001
91687637|NCT03718832|183267941|SUPERIORITY||Mean Difference (Net)|0.0377244|STANDARD_ERROR_OF_MEAN|0.6523585||0.9539117|TWO_SIDED|95.0|-1.244338|1.319787||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.319787|-1.244338|0.9539117
91687638|NCT03718832|183267942|SUPERIORITY||Mean Difference (Net)|-0.1045328|STANDARD_ERROR_OF_MEAN|0.1417549||0.4612408|TWO_SIDED|95.0|-0.3830955|0.1740299||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1740299|-0.3830955|0.4612408
91687639|NCT03718832|183267942|SUPERIORITY||Mean Difference (Net)|-0.0552724|STANDARD_ERROR_OF_MEAN|0.1181649||0.6401864|TWO_SIDED|95.0|-0.2874987|0.176954||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.176954|-0.2874987|0.6401864
91687640|NCT03718832|183267942|SUPERIORITY||Mean Difference (Net)|-0.2761332|STANDARD_ERROR_OF_MEAN|0.2593125||0.2874913|TWO_SIDED|95.0|-0.7857084|0.2334419||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2334419|-0.7857084|0.2874913
91687641|NCT03718832|183267942|SUPERIORITY||Mean Difference (Net)|-0.155843|STANDARD_ERROR_OF_MEAN|0.2092772||0.4568601|TWO_SIDED|95.0|-0.56713|0.2554439||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2554439|-0.56713|0.4568601
91687642|NCT03718832|183267943|SUPERIORITY||Mean Difference (Net)|0.0539315|STANDARD_ERROR_OF_MEAN|0.0267347||0.0442418|TWO_SIDED|95.0|0.0013953|0.1064678||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1064678|0.0013953|0.0442418
91687643|NCT03718832|183267943|SUPERIORITY||Mean Difference (Net)|0.0546574|STANDARD_ERROR_OF_MEAN|0.0272506||0.0454857|TWO_SIDED|95.0|0.0011025|0.1082124||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.1082124|0.0011025|0.0454857
91687644|NCT03718832|183267943|SUPERIORITY||Mean Difference (Net)|0.0076781|STANDARD_ERROR_OF_MEAN|0.0188378||0.683764|TWO_SIDED|95.0|-0.0293401|0.0446963||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0446963|-0.0293401|0.683764
91687645|NCT03718832|183267943|SUPERIORITY||Mean Difference (Net)|0.0053342|STANDARD_ERROR_OF_MEAN|0.0183059||0.7708852|TWO_SIDED|95.0|-0.0306419|0.0413103||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0413103|-0.0306419|0.7708852
91687646|NCT03718832|183267944|SUPERIORITY||Mean Difference (Net)|-0.053099|STANDARD_ERROR_OF_MEAN|0.0436586||0.2245167|TWO_SIDED|95.0|-0.1388926|0.0326946||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0326946|-0.1388926|0.2245167
91687647|NCT03718832|183267944|SUPERIORITY||Mean Difference (Net)|-0.0815933|STANDARD_ERROR_OF_MEAN|0.0424438||0.0551913|TWO_SIDED|95.0|-0.1650069|0.0018204||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0018204|-0.1650069|0.0551913
91687648|NCT03718832|183267944|SUPERIORITY||Mean Difference (Net)|-0.0506938|STANDARD_ERROR_OF_MEAN|0.0461078||0.2721373|TWO_SIDED|95.0|-0.1413002|0.0399126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0399126|-0.1413002|0.2721373
91687649|NCT03718832|183267944|SUPERIORITY||Mean Difference (Net)|-0.079563|STANDARD_ERROR_OF_MEAN|0.0428514||0.0640071|TWO_SIDED|95.0|-0.1637776|0.0046516||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0046516|-0.1637776|0.0640071
91720922|NCT01013753|183334650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.166|0.259|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.259|0.166|<0.0001
91687650|NCT03718832|183267945|SUPERIORITY||Mean Difference (Net)|13.79692|STANDARD_ERROR_OF_MEAN|808.862||0.9864081|TWO_SIDED|95.0|-1581.244|1608.838||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1608.838|-1581.244|0.9864081
91687651|NCT03718832|183267945|SUPERIORITY||Mean Difference (Net)|119.3302|STANDARD_ERROR_OF_MEAN|885.2058||0.8929133|TWO_SIDED|95.0|-1627.128|1865.789||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1865.789|-1627.128|0.8929133
91687652|NCT03718832|183267945|SUPERIORITY||Mean Difference (Net)|-1260.452|STANDARD_ERROR_OF_MEAN|1327.743||0.343724|TWO_SIDED|95.0|-3880.298|1359.393||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1359.393|-3880.298|0.343724
91687653|NCT03718832|183267945|SUPERIORITY||Mean Difference (Net)|-1206.216|STANDARD_ERROR_OF_MEAN|1344.574||0.3709654|TWO_SIDED|95.0|-3860.887|1448.455||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1448.455|-3860.887|0.3709654
91687654|NCT03718832|183267946|SUPERIORITY||Mean Difference (Net)|1290.605|STANDARD_ERROR_OF_MEAN|732.2306||0.0795087|TWO_SIDED|95.0|-153.3215|2734.532||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2734.532|-153.3215|0.0795087
91687655|NCT03718832|183267946|SUPERIORITY||Mean Difference (Net)|1207.762|STANDARD_ERROR_OF_MEAN|874.6068||0.1689786|TWO_SIDED|95.0|-517.7854|2933.309||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2933.309|-517.7854|0.1689786
91527095|NCT02969525|182929506|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.2|||=|0.032|TWO_SIDED|95.0|1.13|15.23||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||15.23|1.13|=0.032
91527670|NCT01976364|182930490|OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-1.54|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-1.54|
91687656|NCT03718832|183267946|SUPERIORITY||Mean Difference (Net)|1209.35|STANDARD_ERROR_OF_MEAN|957.1006||0.2080145|TWO_SIDED|95.0|-679.1596|3097.86||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||3097.86|-679.1596|0.2080145
91687657|NCT03718832|183267946|SUPERIORITY||Mean Difference (Net)|1258.587|STANDARD_ERROR_OF_MEAN|1077.807||0.2445904|TWO_SIDED|95.0|-869.3893|3386.563||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3386.563|-869.3893|0.2445904
91687658|NCT03718832|183267947|SUPERIORITY||Mean Difference (Net)|2.035245|STANDARD_ERROR_OF_MEAN|0.1415551|<|0.001|TWO_SIDED|95.0|1.757075|2.313415||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.313415|1.757075|<0.001
91687659|NCT03718832|183267947|SUPERIORITY||Mean Difference (Net)|2.0087|STANDARD_ERROR_OF_MEAN|0.1395364|<|0.001|TWO_SIDED|95.0|1.734473|2.282927||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.282927|1.734473|<0.001
91687660|NCT03718832|183267947|SUPERIORITY||Mean Difference (Net)|1.619982|STANDARD_ERROR_OF_MEAN|0.2663507|<|0.001|TWO_SIDED|95.0|1.096575|2.143388||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.143388|1.096575|<0.001
91687661|NCT03718832|183267947|SUPERIORITY||Mean Difference (Net)|1.559642|STANDARD_ERROR_OF_MEAN|0.2680774|<|0.001|TWO_SIDED|95.0|1.032797|2.086488||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.086488|1.032797|<0.001
91687662|NCT03718832|183267948|SUPERIORITY||Mean Difference (Net)|1.881776|STANDARD_ERROR_OF_MEAN|0.1057965|<|0.001|TWO_SIDED|95.0|1.673875|2.089677||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||2.089677|1.673875|<0.001
91687663|NCT03718832|183267948|SUPERIORITY||Mean Difference (Net)|1.868221|STANDARD_ERROR_OF_MEAN|0.1036609|<|0.001|TWO_SIDED|95.0|1.664499|2.071943||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||2.071943|1.664499|<0.001
91687664|NCT03718832|183267948|SUPERIORITY||Mean Difference (Net)|1.650879|STANDARD_ERROR_OF_MEAN|0.2057239|<|0.001|TWO_SIDED|95.0|1.246611|2.055147||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.055147|1.246611|<0.001
91687665|NCT03718832|183267948|SUPERIORITY||Mean Difference (Net)|1.636306|STANDARD_ERROR_OF_MEAN|0.2052192|<|0.001|TWO_SIDED|95.0|1.232994|2.039618||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.039618|1.232994|<0.001
91687666|NCT03718832|183267949|SUPERIORITY||Mean Difference (Net)|0.1104533|STANDARD_ERROR_OF_MEAN|0.0769621||0.1519153|TWO_SIDED|95.0|-0.040785|0.2616915||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||0.2616915|-0.040785|0.1519153
91687667|NCT03718832|183267949|SUPERIORITY||Mean Difference (Net)|0.0594575|STANDARD_ERROR_OF_MEAN|0.0654489||0.3641254|TWO_SIDED|95.0|-0.0691675|0.1880824||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.1880824|-0.0691675|0.3641254
91687668|NCT03718832|183267949|SUPERIORITY||Mean Difference (Net)|0.2062905|STANDARD_ERROR_OF_MEAN|0.1288363||0.1100186|TWO_SIDED|95.0|-0.0468859|0.4594669||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||0.4594669|-0.0468859|0.1100186
91687669|NCT03718832|183267949|SUPERIORITY||Mean Difference (Net)|0.1162375|STANDARD_ERROR_OF_MEAN|0.1015839||0.2531303|TWO_SIDED|95.0|-0.0834025|0.3158775||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||0.3158775|-0.0834025|0.2531303
91687670|NCT03718832|183267950|SUPERIORITY||Mean Difference (Net)|-0.0584644|STANDARD_ERROR_OF_MEAN|0.040837||0.152918|TWO_SIDED|95.0|-0.1387132|0.0217844||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0217844|-0.1387132|0.152918
91687671|NCT03718832|183267950|SUPERIORITY||Mean Difference (Net)|-0.0585771|STANDARD_ERROR_OF_MEAN|0.0304262||0.0548344|TWO_SIDED|95.0|-0.1183728|0.0012186||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.0012186|-0.1183728|0.0548344
91687672|NCT03718832|183267950|SUPERIORITY||Mean Difference (Net)|-0.1691027|STANDARD_ERROR_OF_MEAN|0.0673022||0.0123238|TWO_SIDED|95.0|-0.3013583|-0.036847||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.036847|-0.3013583|0.0123238
91687673|NCT03718832|183267950|SUPERIORITY||Mean Difference (Net)|-0.1701425|STANDARD_ERROR_OF_MEAN|0.0575065||0.0032534|TWO_SIDED|95.0|-0.2831584|-0.0571266||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||-0.0571266|-0.2831584|0.0032534
91687674|NCT01996241|183267968|OTHER|Odds ratio (95% CI), p-value for all the outcomes.|Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.7|1.38||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.38|0.7|0.98
91687675|NCT01996241|183267969|OTHER||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.7|1.4||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.4|0.7|0.98
91687676|NCT01996241|183267970|OTHER||Odds Ratio (OR)|1.32||||0.331|TWO_SIDED|95.0|0.2|2.31||Adjusted for village strata and cluster, village type, caste, household literacy status, stratum using individual-level data and poor learning environment at school, school dropout, and marriage (in the form of cluster-level summaries).|Regression, Logistic|Mixed-effects||||2.31|0.2|0.331
91687677|NCT01996241|183267971|OTHER||Odds Ratio (OR)|0.83||||0.26|TWO_SIDED|95.0|0.6|1.15||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.15|0.6|0.26
91687678|NCT01996241|183267972|OTHER||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.7|1.55||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.55|0.7|0.79
91687679|NCT01996241|183267973|OTHER||Odds Ratio (OR)|0.83||||0.45|TWO_SIDED|95.0|0.5|1.34||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.34|0.5|0.45
91687680|NCT01295112|183267974|SUPERIORITY|||||||2e-05|||||||Cochran-Mantel-Haenszel|||||||0.00002
91687681|NCT01295112|183267975|NON_INFERIORITY|Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA|Mean Difference (Final Values)|2.51|STANDARD_DEVIATION|17.96||0.53|TWO_SIDED|90.0|-4.43|9.74||The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.|t-test, 1 sided|||||9.74|-4.43|0.53
91687682|NCT04882241|183267977|OTHER||Hazard Ratio (HR)|0.92||||0.39528|TWO_SIDED|95.0|0.5|1.7||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.70|0.50|0.39528
91687683|NCT04882241|183267978|OTHER||Difference in Percentage|1.9||||0.33244|TWO_SIDED|95.0|-7.7|12.0|||Miettinen and Nurminen|Based on unstratified Miettinen \& Nurminen method||||12.0|-7.7|0.33244
91687684|NCT04882241|183267979|OTHER||Hazard Ratio (HR)|1.03||||0.52903|TWO_SIDED|95.0|0.48|2.22||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.22|0.48|0.52903
91687685|NCT04882241|183267984|OTHER||Hazard Ratio (HR)|0.83||||0.34632|TWO_SIDED|95.0|0.34|2.05||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.05|0.34|0.34632
91687686|NCT02543944|183267987|SUPERIORITY||Risk Ratio (RR)|-0.0944|STANDARD_ERROR_OF_MEAN|0.32||0.77|TWO_SIDED|95.0|-0.72|0.53|||Regression, Logistic|||||0.53|-0.72|0.77
91687687|NCT02543944|183267988|SUPERIORITY||Odds Ratio (OR)|0.3||||0.58|TWO_SIDED||||||Chi-squared|||||||0.58
91527671|NCT01976364|182930490|OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-1.46|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.46|
91687688|NCT02543944|183267989|SUPERIORITY||Odds Ratio (OR)|0.16||||0.69|TWO_SIDED||||||Chi-squared|||||||0.69
91488409|NCT05224141|182848973|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.9762|TWO_SIDED|95.0|1.0|1.59|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.59|1.00|0.9762
91527096|NCT02969525|182929506|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|8.1|||=|0.001|TWO_SIDED|95.0|2.28|28.74||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||28.74|2.28|=0.001
91687689|NCT02543944|183267990|SUPERIORITY||Odds Ratio (OR)|0.96||||0.32|TWO_SIDED||||||Chi-squared|||||||0.32
91687690|NCT02932462|183267994|SUPERIORITY|||||||0.4557|||||||Cochran-Mantel-Haenszel|||||||0.4557
91687691|NCT02932462|183267995|SUPERIORITY|||||||0.8096|||||||Cochran-Mantel-Haenszel|||||||0.8096
91687692|NCT02932462|183267996|SUPERIORITY|||||||0.7652|||||||Cochran-Mantel-Haenszel|||||||0.7652
91687693|NCT02413229|183267997|SUPERIORITY|||||||0.3571|||||||Cochran-Mantel-Haenszel|||||||0.3571
91687694|NCT02413229|183267997|SUPERIORITY|||||||0.5224|||||||Cochran-Mantel-Haenszel|||||||0.5224
91687695|NCT02413229|183267997|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
91687696|NCT02413229|183267997|SUPERIORITY|||||||0.0325|||||||Cochran-Mantel-Haenszel|||||||.0325
91687697|NCT02091856|183267998|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre \& post||It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.||||<0.001
91687698|NCT02091856|183267999|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).||||||>0.05
91687699|NCT02091856|183268000|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.01
91687700|NCT02091856|183268001|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.001
91687701|NCT02091856|183268002|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|t-test, 1 sided|||||||<0.01
91687702|NCT04584684|183268003|SUPERIORITY|||||||0.89||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.89
91687703|NCT04584684|183268003|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.88
91687704|NCT04584684|183268003|SUPERIORITY|||||||0.82||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.82
91687705|NCT04584684|183268003|SUPERIORITY|||||||0.65||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.65
91687706|NCT04584684|183268003|SUPERIORITY|||||||0.77||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.77
91687707|NCT04584684|183268003|SUPERIORITY|||||||0.76||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.76
91687708|NCT04584684|183268003|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
91687709|NCT04584684|183268003|SUPERIORITY|||||||0.71||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.71
91687710|NCT04584684|183268003|SUPERIORITY|||||||0.6||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.60
91687711|NCT04584684|183268003|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
91687712|NCT02955212|183268018|SUPERIORITY||Response Rate Difference|40.2|||<|0.001|TWO_SIDED|95.0|30.5|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||50.0|30.5|<0.001
91687713|NCT02955212|183268019|SUPERIORITY||Least Squares (LS) Mean Difference|-1.61|||<|0.001|TWO_SIDED|95.0|-1.86|-1.36|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-1.36|-1.86|<0.001
91687714|NCT02955212|183268020|SUPERIORITY||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.55|-0.33|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-0.33|-0.55|<0.001
91687715|NCT02955212|183268021|SUPERIORITY||LS Mean Difference|5.57|||<|0.001|TWO_SIDED|95.0|4.13|7.01|||Mixed Effect Model Repeat Measurement|MMRM model with treatment, visit, treatment-by-visit interaction and stratification factor of country as fixed effects and Baseline value as covariate|LS Mean Difference = Upadacitinib - Placebo|||7.01|4.13|<0.001
91687716|NCT02955212|183268022|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|23.4|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor country.|Response Rate Difference = Upadacitinib - Placebo|||41.7|23.4|<0.001
91687717|NCT02955212|183268023|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|24.3|16.6|31.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||31.9|16.6|<0.001
91687718|NCT02955212|183268024|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|15.6|32.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||32.9|15.6|<0.001
91687719|NCT02955212|183268025|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|24.0|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||41.0|24.0|<0.001
91687720|NCT02955212|183268026|SUPERIORITY||Response Rate Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.0|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||24.5|11.0|<0.001
91687721|NCT02955212|183268027|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|12.1|27.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country|Response Rate Difference = Upadacitinib - Placebo|||27.0|12.1|<0.001
91687722|NCT01311687|183268036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.35|0.59|||Stratified Log Rank Test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.35|<0.001
91687723|NCT01311687|183268037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.61|||Stratified log-rank test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.61|0.39|<0.001
91687724|NCT01311687|183268039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.74|0.37|<0.001
91687725|NCT01311687|183268040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.009|TWO_SIDED|95.0|0.54|0.92|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.92|0.54|0.009
91687726|NCT01311687|183268041|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.91|0.60|0.005
91687727|NCT01311687|183268042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.53|||<|0.001|TWO_SIDED|95.0|3.19|17.77|||Fisher Exact||Odds ratio is for pomalidomide plus low-dose dexamethasone : high dose dexamethasone|||17.77|3.19|< 0.001
91687728|NCT01311687|183268043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.44|||<|0.001|TWO_SIDED|95.0|3.32|21.42|||Fisher Exact||Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||21.42|3.32|< 0.001
91687729|NCT01311687|183268044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Stratified Log Rank Test|Stratified by age, diseases population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.36|< 0.001
91687730|NCT04090125|183268077|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.485|TWO_SIDED|95.0|-0.9|0.43|||Mixed Models Analysis|||||0.43|-0.90|0.485
91687731|NCT04090125|183268078|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0887|TWO_SIDED|95.0|-1.13|0.08|||Mixed Models Analysis|||||0.08|-1.13|0.0887
91687732|NCT04090125|183268079|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.296|TWO_SIDED|95.0|-0.05|0.13|||Mixed Models Analysis|||||0.13|-0.05|0.296
91687733|NCT04090125|183268080|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.094|TWO_SIDED|95.0|-0.15|0.01|||Mixed Models Analysis|||||0.01|-0.15|0.094
91687734|NCT04090125|183268081|SUPERIORITY||Mean Difference (Final Values)|3.85||||0.11|TWO_SIDED|95.0|-0.91|8.62|||Mixed Models Analysis|||||8.62|-0.91|0.11
91687735|NCT04090125|183268082|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.55|TWO_SIDED|95.0|-4.1|7.59|||Mixed Models Analysis|||||7.59|-4.10|0.55
91687736|NCT04090125|183268083|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.134|TWO_SIDED|95.0|-0.34|0.05|||Mixed Models Analysis|||||0.05|-0.34|0.134
91687737|NCT04090125|183268084|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.09|TWO_SIDED|95.0|-0.38|0.03|||Mixed Models Analysis|||||0.03|-0.38|0.09
91687738|NCT04090125|183268085|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.25|TWO_SIDED|95.0|-0.16|0.04|||Mixed Models Analysis|||||0.04|-0.16|0.25
91687739|NCT04090125|183268086|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.16|TWO_SIDED|95.0|-0.22|0.04|||Mixed Models Analysis|||||0.04|-0.22|0.16
91687740|NCT04090125|183268087|SUPERIORITY||Mean Difference (Final Values)|21.36||||0.167|TWO_SIDED|95.0|-9.29|52.02|||Mixed Models Analysis|||||52.02|-9.29|0.167
91687741|NCT04090125|183268088|SUPERIORITY||Mean Difference (Final Values)|25.15||||0.189|TWO_SIDED|95.0|-12.85|63.14|||Mixed Models Analysis|||||63.14|-12.85|0.189
91687742|NCT04090125|183268093|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.42|TWO_SIDED|95.0|-3.65|8.67|||Mixed Models Analysis|||Pain subscale||8.67|-3.65|0.42
91687743|NCT04090125|183268093|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.76|TWO_SIDED|95.0|-6.29|8.57|||Mixed Models Analysis|||Symptoms subscale||8.57|-6.29|0.76
91687744|NCT04090125|183268093|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.46|TWO_SIDED|95.0|-13.2|6.12|||Mixed Models Analysis|||Quality of life subscale||6.12|-13.20|0.46
91687745|NCT04090125|183268093|SUPERIORITY||Mean Difference (Final Values)|2.54||||0.22|TWO_SIDED|95.0|-1.61|6.69|||Mixed Models Analysis|||Function in daily life||6.69|-1.61|0.22
91687746|NCT04090125|183268094|SUPERIORITY||Mean Difference (Final Values)|1.43||||0.65|TWO_SIDED|95.0|-4.98|7.85|||Mixed Models Analysis|||Pain subscale||7.85|-4.98|0.65
91687747|NCT04090125|183268094|SUPERIORITY||Mean Difference (Final Values)|3.95||||0.32|TWO_SIDED|95.0|-3.93|11.83|||Mixed Models Analysis|||Symptoms subscale||11.83|-3.93|0.32
91687748|NCT04090125|183268094|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.77|TWO_SIDED|95.0|-9.61|12.89|||Mixed Models Analysis|||Quality of life||12.89|-9.61|0.77
91687749|NCT04090125|183268094|SUPERIORITY||Mean Difference (Final Values)|3.25||||0.19|TWO_SIDED|95.0|-1.67|8.17|||Mixed Models Analysis|||Function in daily life||8.17|-1.67|0.19
91687750|NCT04090125|183268095|SUPERIORITY||Mean Difference (Final Values)|-1.95||||0.191|TWO_SIDED|95.0|-4.92|1.01|||Mixed Models Analysis|||||1.01|-4.92|0.191
91687751|NCT04090125|183268096|SUPERIORITY||Mean Difference (Final Values)|-5.45||||0.0004|TWO_SIDED|95.0|-8.28|-2.62|||Mixed Models Analysis|||||-2.62|-8.28|0.0004
91687752|NCT01342081|183268097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3|||ANCOVA|||||-1.3|-2.1|< 0.001
91687753|NCT01342081|183268097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Non-inferiority was evaluated after superiority to tafluprost was confirmed.||0.1|-0.7|
91687754|NCT03440840|183268102|SUPERIORITY||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|2.68||0.4|TWO_SIDED||||||Mixed Models Analysis|Estimated marginal means comparisons, Tukey adjustment||||||0.40
91687755|NCT03440840|183268103|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED|||||Estimated marginal means comparisons, Tukey adjustment|Mixed Models Analysis|||||||0.37
91687756|NCT03440840|183268104|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED||||||Mixed Models Analysis|Comparison of estimated marginal means, Tukey adjustment for multiple comparisons||||||0.37
91687757|NCT03440840|183268105|SUPERIORITY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED||||||Mixed Models Analysis||Differences between estimated marginal means, Tukey correction for multiple comparisons.|||||0.61
91720923|NCT01013753|183334650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.186|0.28|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.280|0.186|<0.0001
91687758|NCT04807400|183268182|SUPERIORITY||Least Squares Mean|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-37.91|-25.77||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.77|-37.91|<0.001
91687759|NCT04807400|183268182|SUPERIORITY||Least Squares Mean|-32.1|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-38.35|-25.94||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.94|-38.35|<0.001
91687760|NCT04807400|183268184|SUPERIORITY||Least-squares Mean|1.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|0.62|2.13|||ANOVA|||||2.13|0.62|<0.001
91687761|NCT04807400|183268184|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|0.6|2.1|||ANOVA|||||2.10|0.60|<0.001
91687762|NCT04807400|183268185|SUPERIORITY||Least-squares Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.326||0.9347|TWO_SIDED|95.0|-0.67|0.61|||ANOVA|||||0.61|-0.67|0.9347
91687763|NCT04807400|183268186|SUPERIORITY||Least-squares Mean|1.0|STANDARD_ERROR_OF_MEAN|2.34||0.6759|TWO_SIDED|95.0|-3.62|5.58|||ANCOVA|||||5.58|-3.62|0.6759
91687764|NCT04807400|183268186|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|2.31||0.5756|TWO_SIDED|95.0|-3.25|5.84|||ANCOVA|||||5.84|-3.25|0.5756
91687765|NCT04807400|183268187|SUPERIORITY||Least-squares Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69||0.858|TWO_SIDED|95.0|-3.02|3.62|||ANCOVA|||||3.62|-3.02|0.8580
91687766|NCT04194645|183268190|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|97.71|||||TWO_SIDED|90.0|91.45|104.4|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||104.40|91.45|
91687767|NCT04194645|183268190|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.88|||||TWO_SIDED|90.0|98.82|128.94|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.8|No formal hypothesis was tested.||128.94|98.82|
91687768|NCT04194645|183268191|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|48.02|||||TWO_SIDED|90.0|41.86|55.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 18.5|No formal hypothesis was tested.||55.09|41.86|
91720924|NCT01013753|183334650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.203|0.298|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.298|0.203|<0.0001
91720925|NCT01013753|183334650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.137|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.231|0.137|<0.0001
91720926|NCT01013753|183334651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.073|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.158|0.073|<0.0001
91720927|NCT01013753|183334651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
91527672|NCT01976364|182930491|OTHER||LS mean difference|-0.36|||||TWO_SIDED|95.0|-2.06|1.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.35|-2.06|
91687769|NCT04194645|183268191|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|122.8|||||TWO_SIDED|90.0|105.04|143.56|||ANOVA||Intra- individual coefficient of variation (gCV %) = 19.8|No formal hypothesis was tested.||143.56|105.04|
91687770|NCT04194645|183268194|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|98.32|||||TWO_SIDED|90.0|91.98|105.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||105.09|91.98|
91687771|NCT04194645|183268194|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.94|||||TWO_SIDED|90.0|98.75|129.18|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.9|No formal hypothesis was tested.||129.18|98.75|
91687772|NCT03656744|183268195|SUPERIORITY|||||||0.199|||||||ANCOVA|||||||0.199
91687773|NCT03656744|183268195|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
91687774|NCT03656744|183268196|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
91687775|NCT03656744|183268196|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||0.109
91687776|NCT03656744|183268197|SUPERIORITY|||||||0.034|||||||ANCOVA|||||||0.034
91687777|NCT03656744|183268197|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
91687778|NCT03656744|183268198|SUPERIORITY|||||||0.884|||||||Regression, Logistic|||||||0.884
91687779|NCT03656744|183268198|SUPERIORITY|||||||0.236|||||||Regression, Logistic|||||||0.236
91687780|NCT03656744|183268199|SUPERIORITY|||||||0.196|||||||ANCOVA|||||||0.196
91687781|NCT03656744|183268199|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
91687782|NCT03656744|183268200|SUPERIORITY|||||||0.294|||||||Cochran-Mantel-Haenszel|||||||0.294
91687783|NCT03656744|183268201|SUPERIORITY|||||||0.287|||||||Regression, Logistic|||||||0.287
91687784|NCT03656744|183268201|SUPERIORITY|||||||0.09|||||||Regression, Logistic|||||||0.090
91687785|NCT03656744|183268202|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
91687786|NCT03656744|183268202|SUPERIORITY|||||||0.534|||||||ANCOVA|||||||0.534
91687787|NCT03656744|183268203|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
91687788|NCT03656744|183268203|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
91687789|NCT03656744|183268204|SUPERIORITY|||||||0.041|||||||ANCOVA|||||||0.041
91687790|NCT03656744|183268204|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||0.120
91720928|NCT01013753|183334651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.135|<0.0001
91720929|NCT01013753|183334651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.164|0.25|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.250|0.164|<0.0001
91720930|NCT01013753|183334651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.11|0.194|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.194|0.110|<0.0001
91687791|NCT03656744|183268205|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
91687792|NCT03656744|183268205|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
91687793|NCT03656744|183268206|SUPERIORITY|||||||0.488|||||||ANCOVA|||||||0.488
91687794|NCT03656744|183268206|SUPERIORITY|||||||0.022|||||||ANCOVA|||||||0.022
91488410|NCT05224141|182848974|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5316|TWO_SIDED|95.0|0.82|1.23|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.23|0.82|0.5316
91527673|NCT01976364|182930491|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.51|0.79||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.79|-2.51|
91687795|NCT03656744|183268207|SUPERIORITY|||||||0.674|||||||ANCOVA|||||||0.674
91687796|NCT03656744|183268207|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.030
91687797|NCT03656744|183268208|SUPERIORITY|||||||0.588|||||||Regression, Logistic|||||||0.588
91687798|NCT03656744|183268208|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
91687799|NCT03656744|183268209|SUPERIORITY|||||||0.236|||||||ANCOVA|||||||0.236
91687800|NCT03656744|183268209|SUPERIORITY|||||||0.944|||||||ANCOVA|||||||0.944
91687801|NCT03656744|183268210|SUPERIORITY|||||||0.267|||||||ANCOVA|||||||0.267
91687802|NCT03656744|183268210|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
91687803|NCT03656744|183268211|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
91687804|NCT03656744|183268211|SUPERIORITY|||||||0.855|||||||ANCOVA|||||||0.855
91687805|NCT03656744|183268212|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||0.107
91687806|NCT03656744|183268212|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||0.489
91687807|NCT03656744|183268213|SUPERIORITY|||||||0.515|||||||ANCOVA|||||||0.515
91687808|NCT03656744|183268213|SUPERIORITY|||||||0.887|||||||ANCOVA|||||||0.887
91687809|NCT03656744|183268214|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
91687810|NCT03656744|183268214|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
91687811|NCT03656744|183268215|SUPERIORITY|||||||0.124|||||||ANCOVA|||||||0.124
91687812|NCT03656744|183268215|SUPERIORITY|||||||0.171|||||||ANCOVA|||||||0.171
91687813|NCT03076775|183268217|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91687814|NCT03076775|183268218|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91687815|NCT03076775|183268219|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91687816|NCT03076775|183268220|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91687817|NCT03076775|183268221|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
91687818|NCT03076775|183268222|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
91687819|NCT03076775|183268223|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91687820|NCT03076775|183268224|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91687821|NCT03076775|183268225|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
91687822|NCT03076775|183268226|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
91687823|NCT01783886|183268232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.1|||<|0.0001|TWO_SIDED|97.5|10.9|17.2|||ANCOVA||Least Square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||17.2|10.9|<0.0001
91687824|NCT01783886|183268232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|97.5|10.2|16.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||16.9|10.2|<0.0001
91687825|NCT01783886|183268233|SUPERIORITY_OR_OTHER||CMH adjusted difference|47.4|||<|0.0001|TWO_SIDED|97.5|35.0|59.9|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH). The estimate is calculated as EYLEA minus Laser.|||59.9|35.0|<0.0001
91687826|NCT01783886|183268233|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.2|||<|0.0001|TWO_SIDED|97.5|26.3|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.1|26.3|<0.0001
91687827|NCT01783886|183268234|SUPERIORITY_OR_OTHER||CMH adjusted difference|31.1|||<|0.0001|TWO_SIDED|97.5|19.2|43.0|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||43.0|19.2|<0.0001
91687828|NCT01783886|183268234|SUPERIORITY_OR_OTHER||CMH adjusted difference|24.3|||<|0.0001|TWO_SIDED|97.5|12.6|35.9|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||35.9|12.6|<0.0001
91687829|NCT01783886|183268235|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.1|||<|0.0001|TWO_SIDED|97.5|26.0|52.2|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.2|26.0|<0.0001
91687830|NCT01783886|183268235|SUPERIORITY_OR_OTHER||CMH adjusted difference|40.6|||<|0.0001|TWO_SIDED|97.5|27.6|53.7|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||53.7|27.6|<0.0001
91687831|NCT01783886|183268236|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-130.5|||<|0.0001|TWO_SIDED|97.5|-171.2|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-171.2|<0.0001
91687832|NCT01783886|183268236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.4|||<|0.0001|TWO_SIDED|97.5|-172.8|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-172.8|<0.0001
91687833|NCT01783886|183268237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78||||0.0364|TWO_SIDED|97.5|-0.41|11.97|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||11.97|-0.41|0.0364
91687834|NCT01783886|183268237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.87||||0.0113|TWO_SIDED|97.5|0.8|12.94|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||12.94|0.80|0.0113
91687835|NCT01783886|183268238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.2688|TWO_SIDED|97.5|-2.9|8.53|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||8.53|-2.90|0.2688
91687836|NCT01783886|183268238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.01||||0.0009|TWO_SIDED|97.5|2.64|13.37|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||13.37|2.64|0.0009
91720931|NCT01013753|183334652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.056|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.056|<0.0001
91720932|NCT01013753|183334652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.180|0.090|<0.0001
91720933|NCT01013753|183334652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.116|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.207|0.116|<0.0001
91720934|NCT01013753|183334652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.134|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.226|0.134|<0.0001
91720935|NCT01013753|183334652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.12|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.120|<0.0001
91720936|NCT01013753|183334653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.058|<0.0001
91488411|NCT05224141|182848975|SUPERIORITY||Percent Difference|-3.1|||||TWO_SIDED|95.0|-11.1|4.9|||||Based on Miettinen \& Nurminen method stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||4.9|-11.1|
91687837|NCT03541317|183268291|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of CBT sessions delivered to students by SPs over the four post-randomization phases during Stages 1 and 2|Difference in sum of means*|9.7||||0.63|TWO_SIDED|95.0|-30.03|49.4|||weighted least squares regression|Marginal means under each implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne, \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase.|||49.40|-30.03|0.63
91720937|NCT01013753|183334653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.088|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.177|0.088|<0.0001
91720938|NCT01013753|183334653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.124|0.214|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.214|0.124|<0.0001
91720939|NCT01013753|183334653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.153|0.244|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.244|0.153|<0.0001
91720940|NCT01013753|183334653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.147|0.058|<0.0001
91527674|NCT01976364|182930491|OTHER||LS mean difference|-1.71|||||TWO_SIDED|95.0|-3.66|0.23||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.23|-3.66|
91720941|NCT01013753|183334654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.052|0.154|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.154|0.052|<0.0001
91720942|NCT01013753|183334654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.106|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.106|<0.0001
91720943|NCT01013753|183334654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.091|0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.192|0.091|<0.0001
91720944|NCT01013753|183334654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.118|0.221|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.221|0.118|<0.0001
91720945|NCT01013753|183334654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.051|0.153|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.153|0.051|<0.0001
91720946|NCT01013753|183334655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0107||95.0|0.014|0.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.107|0.014|0.0107
91527675|NCT01976364|182930491|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.25|1.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.32|-2.25|
91488412|NCT02390908|182849006|SUPERIORITY||Beta|0.22||||0.39|TWO_SIDED|95.0|-0.28|0.72||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.72|-0.28|0.39
91720947|NCT01013753|183334655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.069|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.160|0.069|<0.0001
91720948|NCT01013753|183334655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.069|0.161|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.161|0.069|<0.0001
91687838|NCT03541317|183268292|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\<15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|3.78||||0.72|TWO_SIDED|95.0|-16.88|24.44|||weighted least squares regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase|||24.44|-16.88|0.72
91687839|NCT03541317|183268293|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\>15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|7.85||||0.46|TWO_SIDED|95.0|-13.2|28.91|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|||28.91|-13.20|0.46
91687840|NCT03541317|183268294|SUPERIORITY||Difference in sum of means*|-0.66||||0.87|TWO_SIDED|95.0|-8.49|7.16|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of group CBT sessions delivered to students by SPs over the four post-randomization phase occurring during Stages 1 and 2.||7.16|-8.49|0.87
91687841|NCT00879086|183268295|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-16.7|||=|0.0941|TWO_SIDED|95.0|-36.1|2.4||The two treatment groups were compared, controlling for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (less than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||2.4|-36.1|=0.0941
91687842|NCT00879086|183268296|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-18.4||||0.0492|TWO_SIDED|95.0|-36.0|-0.3||Controlled for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||-0.3|-36.0|0.0492
91720949|NCT01013753|183334655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.098|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.191|0.098|<0.0001
91720950|NCT01013753|183334655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.044|0.137|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.137|0.044|0.0001
91720951|NCT01013753|183334656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.023||0.0005||95.0|0.036|0.128|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.128|0.036|0.0005
91720952|NCT01013753|183334656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.181|0.090|<0.0001
91720953|NCT01013753|183334656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.174|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.174|0.083|<0.0001
91488413|NCT02390908|182849006|SUPERIORITY||Beta|-0.03||||0.94|TWO_SIDED|95.0|-0.84|0.79||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.79|-0.84|0.94
91687843|NCT02517463|183268310|NON_INFERIORITY_OR_EQUIVALENCE|"The PPP from a previous study was 67.2%. Assuming the PPP in the preovulatory and post-ovulatory groups were equivalent, and taking 10% to be the maximum permitted difference for equivalence, a minimum of 273 subjects in each group would be required to confirm equivalence between the two groups with a power of 80% and type I error of 0.05. Therefore, our recruitment of 700 subjects with more than 300 in each group was sufficient."|||||<|0.0001|||||||Chi-squared|||||||<0.0001
91687844|NCT02517463|183268311|SUPERIORITY_OR_OTHER|||||||0.564|TWO_SIDED||||||Fisher Exact|||||||0.564
91687845|NCT02517463|183268312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91687846|NCT04386616|183268317|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9266|TWO_SIDED|95.0|0.75|1.36||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.75|0.9266
91687847|NCT04386616|183268317|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.357|TWO_SIDED|95.0|0.86|1.54||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.54|0.86|0.3570
91687848|NCT04386616|183268317|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9812|TWO_SIDED|95.0|0.74|1.36||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.74|0.9812
91687849|NCT04386616|183268317|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5151|TWO_SIDED|95.0|0.82|1.49||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.49|0.82|0.5151
91687850|NCT04386616|183268318|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8373|TWO_SIDED|95.0|0.77|1.39|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.77|0.8373
91687851|NCT04386616|183268318|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3396|TWO_SIDED|95.0|0.86|1.55|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.55|0.86|0.3396
91687852|NCT04386616|183268318|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8619|TWO_SIDED|95.0|0.76|1.39|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.76|0.8619
91687853|NCT04386616|183268318|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4913|TWO_SIDED|95.0|0.82|1.5|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.50|0.82|0.4913
91687854|NCT04386616|183268319|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4711|TWO_SIDED|95.0|0.83|1.49|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.49|0.83|0.4711
91687855|NCT04386616|183268319|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3135|TWO_SIDED|95.0|0.87|1.56|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.56|0.87|0.3135
91687856|NCT04386616|183268319|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5735|TWO_SIDED|95.0|0.81|1.48|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.48|0.81|0.5735
91687857|NCT04386616|183268319|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5973|TWO_SIDED|95.0|0.8|1.46|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.46|0.80|0.5973
91687858|NCT04386616|183268320|SUPERIORITY||Median Difference (Net)|-1.0||||0.5304|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5304
91687859|NCT04386616|183268320|SUPERIORITY||Median Difference (Net)|-4.5||||0.5058|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.5058
91687860|NCT04386616|183268321|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8451|TWO_SIDED|95.0|0.64|1.72|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.72|0.64|0.8451
91687861|NCT04386616|183268321|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7267|TWO_SIDED|95.0|0.67|1.79|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.79|0.67|0.7267
91687862|NCT04386616|183268321|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8458|TWO_SIDED|95.0|0.63|1.79|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.79|0.63|0.8458
91687863|NCT04386616|183268321|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7907|TWO_SIDED|95.0|0.64|1.81|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.81|0.64|0.7907
91687864|NCT04386616|183268322|SUPERIORITY||Median Difference (Final Values)|0.0||||0.5273|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5273
91687865|NCT04386616|183268322|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6515|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.6515
91687866|NCT04386616|183268322|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5475|TWO_SIDED|95.0|0.71|1.91|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.91|0.71|0.5475
91687867|NCT04386616|183268322|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5652|TWO_SIDED|95.0|0.71|1.89|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.89|0.71|0.5652
91687868|NCT04386616|183268323|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3401|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.3401
91687869|NCT04386616|183268323|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4676|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.4676
91687870|NCT04386616|183268323|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3408|TWO_SIDED|95.0|0.75|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.29|0.75|0.3408
91687871|NCT04386616|183268323|SUPERIORITY||Odds Ratio (OR)|1.32||||0.332|TWO_SIDED|95.0|0.76|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.29|0.76|0.3320
91687872|NCT04386616|183268324|SUPERIORITY||Difference in percentage of participants|3.83|||||TWO_SIDED|95.0|-7.57|15.24|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||15.24|-7.57|
91687873|NCT04386616|183268324|SUPERIORITY||Difference in percentage of participants|-0.38|||||TWO_SIDED|95.0|-11.46|10.7|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.70|-11.46|
91687874|NCT04386616|183268324|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4804|TWO_SIDED|95.0|0.7|2.1|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.10|0.70|0.4804
91687875|NCT04386616|183268324|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9418|TWO_SIDED|95.0|0.56|1.71|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.71|0.56|0.9418
91687876|NCT04386616|183268324|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4988|TWO_SIDED|95.0|0.68|2.44|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.44|0.68|0.4988
91687877|NCT04386616|183268324|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9043|TWO_SIDED|95.0|0.54|1.96|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.96|0.54|0.9043
91687878|NCT04386616|183268325|SUPERIORITY||Median Difference (Net)|0.0||||0.8007|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.8007
91687879|NCT04386616|183268325|SUPERIORITY||Median Difference (Net)|0.0||||0.8633|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.8633
91687880|NCT04386616|183268326|SUPERIORITY||Difference in percentage of participants|-3.59|||||TWO_SIDED|95.0|-16.31|9.12|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.12|-16.31|
91687881|NCT04386616|183268326|SUPERIORITY||Difference in percentage of participants|-12.0|||||TWO_SIDED|95.0|-24.67|0.67|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||0.67|-24.67|
91687882|NCT04386616|183268326|SUPERIORITY||Odds Ratio (OR)|0.86||||0.556|TWO_SIDED|95.0|0.53|1.41|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.41|0.53|0.5560
91687883|NCT04386616|183268326|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0502|TWO_SIDED|95.0|0.38|1.0|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.00|0.38|0.0502
91687884|NCT04386616|183268326|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7002|TWO_SIDED|95.0|0.51|1.6|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.60|0.51|0.7002
91687885|NCT04386616|183268326|SUPERIORITY||Odds Ratio (OR)|0.57||||0.0448|TWO_SIDED|95.0|0.32|0.99|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||0.99|0.32|0.0448
91687886|NCT04386616|183268327|SUPERIORITY||Median Difference (Net)|-0.48||||0.4845|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.4845
91687887|NCT04386616|183268327|SUPERIORITY||Median Difference (Net)|-3.1||||0.057|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.0570
91687888|NCT04386616|183268328|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.4456|TWO_SIDED|95.0|0.76|1.88|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.88|0.76|0.4456
91687889|NCT04386616|183268328|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7213|TWO_SIDED|95.0|0.57|1.48|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.48|0.57|0.7213
91687890|NCT04386616|183268328|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3963|TWO_SIDED|95.0|0.77|1.96|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.96|0.77|0.3963
91687891|NCT04386616|183268328|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9174|TWO_SIDED|95.0|0.6|1.58|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.58|0.60|0.9174
91687892|NCT04386616|183268329|OTHER||Difference in Mortality Rates|2.49|||||TWO_SIDED|95.0|-4.51|9.49|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.49|-4.51|
91720954|NCT01013753|183334656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.111|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.203|0.111|<0.0001
91687893|NCT04386616|183268329|OTHER||Difference in Mortality Rates|2.36|||||TWO_SIDED|95.0|-4.58|9.31|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||9.31|-4.58|
91687894|NCT04386616|183268329|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4336|TWO_SIDED|95.0|0.57|3.74|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.74|0.57|0.4336
91687895|NCT04386616|183268329|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4543|TWO_SIDED|95.0|0.56|3.68|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||3.68|0.56|0.4543
91687896|NCT04386616|183268329|SUPERIORITY||Odds Ratio (OR)|1.46||||0.49|TWO_SIDED|95.0|0.54|3.97|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.97|0.54|0.4900
91687897|NCT04386616|183268329|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3595|TWO_SIDED|95.0|0.58|4.28|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||4.28|0.58|0.3595
91687898|NCT04386616|183268330|OTHER||Difference in Mortality Rates|3.42|||||TWO_SIDED|95.0|-5.42|12.26|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||12.26|-5.42|
91687899|NCT04386616|183268330|OTHER||Difference in Mortality Rates|1.68|||||TWO_SIDED|95.0|-6.89|10.26|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.26|-6.89|
91687900|NCT04386616|183268330|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4067|TWO_SIDED|95.0|0.66|2.8|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.80|0.66|0.4067
91687901|NCT04386616|183268330|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6728|TWO_SIDED|95.0|0.56|2.46|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.46|0.56|0.6728
91687902|NCT04386616|183268330|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5495|TWO_SIDED|95.0|0.62|2.87|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.87|0.62|0.5495
91687903|NCT04386616|183268330|SUPERIORITY||Odds Ratio (OR)|1.24||||0.5551|TWO_SIDED|95.0|0.57|2.71|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.71|0.57|0.5551
91687904|NCT04386616|183268331|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.3831|TWO_SIDED|95.0|0.71|2.4|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.40|0.71|0.3831
91687905|NCT04386616|183268331|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5925|TWO_SIDED|95.0|0.65|2.15|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.15|0.65|0.5925
91687906|NCT04386616|183268331|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7487|TWO_SIDED|95.0|0.6|2.05|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.05|0.60|0.7487
91687907|NCT04386616|183268331|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.6092|TWO_SIDED|95.0|0.63|2.21|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.21|0.63|0.6092
91687908|NCT01377012|183268342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
91687909|NCT01377012|183268342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
91687910|NCT02972892|183268363|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|10.9|||<|0.001|TWO_SIDED|95.0|6.89|15.01|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||15.01|6.89|<.001
91687911|NCT02972892|183268364|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|52.1|||<|0.001|TWO_SIDED|95.0|46.25|57.95|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||57.95|46.25|<.001
91687912|NCT02972892|183268365|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.64|8.04|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||8.04|2.64|<.001
91687913|NCT02972892|183268366|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|44.5|||<|0.001|TWO_SIDED|95.0|35.56|53.41|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||53.41|35.56|<.001
91687914|NCT03503669|183268398|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91687915|NCT03503669|183268399|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
91687916|NCT03503669|183268400|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91687917|NCT03503669|183268401|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91687918|NCT03503669|183268402|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91687919|NCT01068262|183268413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.2|||||TWO_SIDED|90.0|50.9|80.2|||Linear mixed effect model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||80.2|50.9|
91488414|NCT02390908|182849006|SUPERIORITY||Beta|0.02||||0.95|TWO_SIDED|95.0|-0.69|0.74||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.74|-0.69|0.95
91720955|NCT01013753|183334656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.051|0.143|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.143|0.051|<0.0001
91720956|NCT01013753|183334657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.028||0.0952||95.0|-0.008|0.103|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.103|-0.008|0.0952
91720957|NCT01013753|183334657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.028||0.0003||95.0|0.048|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.158|0.048|0.0003
91720958|NCT01013753|183334657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.028||0.0016||95.0|0.034|0.145|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.145|0.034|0.0016
91720959|NCT01013753|183334657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.071|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.183|0.071|<0.0001
91720960|NCT01013753|183334657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.028||0.0096||95.0|0.018|0.129|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.129|0.018|0.0096
91720961|NCT01013753|183334658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.147||95.0|-0.013|0.088|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.088|-0.013|0.1470
91720962|NCT01013753|183334658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0003||95.0|0.042|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.141|0.042|0.0003
91720963|NCT01013753|183334658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.06|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.160|0.060|<0.0001
91720964|NCT01013753|183334658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.078|0.179|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.179|0.078|<0.0001
91720965|NCT01013753|183334658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.025||0.0448||95.0|0.001|0.101|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.101|0.001|0.0448
91720966|NCT01013753|183334659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.408|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.277|0.539|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.539|0.277|<0.0001
91720967|NCT01013753|183334659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.566|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.438|0.695|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.695|0.438|<0.0001
91720968|NCT01013753|183334659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.612|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.482|0.743|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.743|0.482|<0.0001
91720969|NCT01013753|183334659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.539|0.801|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.801|0.539|<0.0001
91720970|NCT01013753|183334659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.457|0.718|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.718|0.457|<0.0001
91720971|NCT01013753|183334660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.213|0.461|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.461|0.213|<0.0001
91720972|NCT01013753|183334660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.485|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.363|0.606|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.606|0.363|<0.0001
91488415|NCT02390908|182849006|SUPERIORITY||Beta|-0.32||||0.09|TWO_SIDED|95.0|-0.69|0.05||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.05|-0.69|0.09
91687920|NCT01068262|183268413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-14.7|14.9|||Linear mixed effects model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||14.9|-14.7|
91687921|NCT01068262|183268414|SUPERIORITY_OR_OTHER||Estimate|0.9|||||TWO_SIDED|90.0|0.75|1.07||Hypothesis: Following 4 weeks of Qw oral dosing of Odanacatib 50 mg, there is no clinically important difference in the true GMR (male/postmenopausal female) of the AUC0-168hr. The GMR is contained within the interval (0.4, 2.0).|Geometric Mean Ratio (GMR); male/female|||||1.07|0.75|
91687922|NCT01068262|183268415|SUPERIORITY_OR_OTHER||GMR|0.93|||||TWO_SIDED|90.0|0.82|1.04|||GMR|||||1.04|0.82|
91687923|NCT01068262|183268416|SUPERIORITY_OR_OTHER||Estimate|0.95|||||TWO_SIDED|90.0|0.66|1.35|||GMR|||||1.35|0.66|
91687924|NCT01811472|183268424|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-1.69||||0.3128|TWO_SIDED|90.0|-4.46|1.09|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.||1.09|-4.46|0.3128
91687925|NCT01811472|183268424|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-2.89||||0.0457|TWO_SIDED|90.0|-5.25|-0.53|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.||-0.53|-5.25|0.0457
91687926|NCT03105518|183268442|SUPERIORITY||1 way test, chisquare approximation|7.188||||0.007|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 0; Follicles ≤10 vs. \> 10||||0.007
91687927|NCT03105518|183268442|SUPERIORITY||1 way Test, ChiSquare Approximation|3.6396||||0.056|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 15; Follicles ≤10 vs. \> 10||||0.056
91687928|NCT03105518|183268442|SUPERIORITY||1 way Test, ChiSquare Approximation|15.971|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 30; Follicles ≤10 vs. \> 10||||<0.0001
91687929|NCT03105518|183268442|SUPERIORITY||1-way Test, ChiSquare Approximation|16.0972|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 60; Follicles ≤10 vs. \> 10||||<0.0001
91687930|NCT03105518|183268443|SUPERIORITY||1-way Test, ChiSquare Approximation|2.7205||||0.0991|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 1; Follicles ≤10 vs. \> 10||||0.0991
91687931|NCT03105518|183268443|SUPERIORITY||1 way Test, ChiSquare Approximation|1.5654||||0.2109|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 2; Follicles ≤10 vs. \> 10||||0.2109
91687932|NCT03105518|183268443|SUPERIORITY||1-way Test, ChiSquare Approximation|0.008||||0.9287|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 3; Follicles ≤10 vs. \> 10||||0.9287
91687933|NCT05262387|183268461|OTHER||Mean Difference (Final Values)|9.32||||0.0494|TWO_SIDED|90.0|1.52|17.1|||Mixed Models Analysis|||||17.1|1.52|0.0494
91720973|NCT01013753|183334660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.531|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.408|0.655|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.655|0.408|<0.0001
91720974|NCT01013753|183334660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.648|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.524|0.772|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.772|0.524|<0.0001
91720975|NCT01013753|183334660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.551|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.428|0.674|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.674|0.428|<0.0001
91720976|NCT01013753|183334661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.373|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.253|0.493|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.493|0.253|<0.0001
91687934|NCT05262387|183268461|OTHER||Mean Difference (Final Values)|14.1||||0.0028|TWO_SIDED|90.0|6.38|21.9|||Mixed Models Analysis|||||21.9|6.38|0.0028
91687935|NCT05262387|183268462|OTHER||Mean Difference (Final Values)|-44.5||||0.1998|TWO_SIDED|90.0|-102.0|12.8|||Mixed Models Analysis|||||12.8|-102|0.1998
91687936|NCT05262387|183268462|OTHER||Mean Difference (Final Values)|4.16||||0.9041|TWO_SIDED|90.0|-53.1|61.4|||Mixed Models Analysis|||||61.4|-53.1|0.9041
91687937|NCT02045446|183268463|SUPERIORITY||Hazard Ratio (HR)|0.304||||0.01|TWO_SIDED|95.0|0.113|0.815|||Log Rank|||||0.815|0.113|.01
91687938|NCT05274178|183268468|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
91687939|NCT05274178|183268468|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
91687940|NCT02515331|183268470|SUPERIORITY||Mean Difference (Net)|-8.555|STANDARD_ERROR_OF_MEAN|2.9077||0.002|TWO_SIDED|95.0|-14.388|-2.722||1-sided p-value|Longitudinal repeated measures mixed eff|||||-2.722|-14.388|0.002
91687941|NCT02515331|183268470|SUPERIORITY||Mean Difference (Net)|-14.727|STANDARD_ERROR_OF_MEAN|3.0548|<|0.001|TWO_SIDED|95.0|-20.852|-8.602||1-sided p-value|Longitudinal repeated measures mixed eff|||||-8.602|-20.852|<0.001
91687942|NCT04688671|183268557|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.302||0.5605|TWO_SIDED|90.0|-0.32|0.68|||Mixed Models Analysis|||||0.68|-0.32|0.5605
91687943|NCT03282916|183268608|SUPERIORITY|Linear mixed-effects models (LMM) were used to assess the treatment effects on the outcome with change score from baseline as the dependent variable and treatment, study time point, and their interaction as predictors, adjusting for baseline value of the outcome.|Mean Difference (Final Values)|3.91|||<|0.05|TWO_SIDED|95.0|1.03|6.8||Not adjusted for multiple comparisons|Mixed Models Analysis|Adjusting for baseline value of ADAS-Cog11||"Null hypothesis: there is no difference in change in ADAS-Cog11 between valacyclovir and placebo treatment.~A sample size of 130 participants (65 per arm) was originally projected to detect Cohen's d of 0.50 with 80% power at 5% significance level. Recruitment target was reduced to 120 participants due to pandemic-related recruitment delays and required study completion within the extended funding timeline. For n=120, the minimum detectable effect size increased slightly to Cohen's d of 0.52."||6.80|1.03|<0.05
91687944|NCT00719186|183268612|SUPERIORITY_OR_OTHER|||||||0.007|||||||Chi-squared|||||||0.007
91687945|NCT02096744|183268631|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.33|STANDARD_ERROR_OF_MEAN|19.0|<|0.0001|TWO_SIDED|90.0|95.74|109.37|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||109.37|95.74|<0.0001
91687946|NCT02096744|183268632|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.25|STANDARD_ERROR_OF_MEAN|16.6|<|0.0001|TWO_SIDED|90.0|98.367|110.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.487|98.367|<0.0001
91687947|NCT02096744|183268633|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.78|STANDARD_ERROR_OF_MEAN|15.8|<|0.0001|TWO_SIDED|90.0|97.25|108.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||108.63|97.25|<0.0001
91687948|NCT02096744|183268634|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.04|STANDARD_ERROR_OF_MEAN|16.7|<|0.0001|TWO_SIDED|90.0|98.148|110.294|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group','sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.294|98.148|<0.0001
91687949|NCT05724589|183268641|SUPERIORITY|A repeated measures ANOVA was selected to analyze changes in skin hydration across four time points within the same participants..|Mean Difference (Final Values)|2.671||||1|TWO_SIDED|||||The p-value reflects the overall test for difference in hydration over time and is not adjusted for multiple comparisons. The pre-defined threshold for statistical significance was p \< 0.05.|ANOVA|No additional adjustments were applied. Degrees of freedom and sphericity assumptions were checked.|The mean difference was calculated based on changes in skin hydration from baseline to Week 16 using repeated measures ANOVA, in accordance with the pre-specified statistical analysis plan.|Skin hydration was evaluated longitudinally using repeated measures ANOVA at Baseline, Week 8, Week 12, and Week 16. This pre-specified statistical test assessed within-subject changes over time to determine the efficacy of the serum.|The overall p-value corresponds to the repeated measures ANOVA evaluating changes over four time points. No multiplicity adjustments were applied.|||1.000
91687950|NCT05724589|183268642|SUPERIORITY|The statistical analysis in this study to assess changes in Transepidermal Water Loss (TEWL) after serum application involved a repeated measures analysis of variance (ANOVA). This approach allows for the examination of differences in TEWL across multiple time points (baseline, 8 weeks, 12 weeks, and 16 weeks) within the same individuals. The use of repeated measures ANOVA accounts for the correlated nature of the data, as multiple measurements are obtained from each participant over time.|Mean Difference (Final Values)|-3.656||||0.096|TWO_SIDED|||||A repeated measures ANOVA was used to assess changes in hydration over time. The mean difference between baseline and 16 weeks was -3.656 (arbitrary units). Results are presented in the corresponding outcome measure table.|ANOVA|||||||0.096
91687951|NCT05724589|183268643|SUPERIORITY|The chosen test was designed to assess whether application of the intervention resulted in any statistically significant differences over time in the primary outcome measure, assuming superiority.|Mean Difference (Final Values)|-0.043||||0.169|TWO_SIDED|||||The pre-specified significance threshold was set at p \< 0.05. No adjustments for multiple comparisons were applied.|ANOVA|Sphericity tested; Greenhouse-Geisser applied if needed. Repeated measures ANOVA accounted for within-subject correlations.|The estimation parameter reflects the change in the R2 elasticity measure from baseline to 16 weeks. The direction of change is based on the final minus baseline value, with baseline serving as the reference point.|The statistical analysis utilized repeated measures ANOVA to evaluate changes in facial skin elasticity (R2 parameter) across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants. This approach accounts for the correlation of repeated measures over time.||||0.169
91687952|NCT05724589|183268644|SUPERIORITY|This study aimed to evaluate changes in wrinkle scores using a 4-grade percentage wrinkle improvement scale across different time points, including baseline, 8 weeks, 12 weeks, and 16 weeks|Mean Difference (Final Values)|1.0||||1|TWO_SIDED||||||ANOVA||The Mean Difference represents the change in wrinkle scores from baseline (Day 0) to follow-up at Week 8, Week 12, or Week 16. For example, a Mean Difference of 1.0 indicates a 1-point improvement from baseline to Week 16 (Week 16 - baseline score).|||||1.000
91687953|NCT05724589|183268645|SUPERIORITY|Repeated measures ANOVA was used to detect any change in facial melanin levels due to the intervention.|Mean Difference (Final Values)|-3.458||||1|TWO_SIDED|||||The p-value indicates no statistically significant change in facial melanin index over time. The p-value was not adjusted for multiple comparisons. Statistical significance was pre-specified at p \< 0.05.|ANOVA|Sphericity assumptions were checked and addressed as needed (e.g., Greenhouse-Geisser correction).|The estimation parameter reflects the mean change in melanin index from baseline to week 16. Baseline was used as the reference point in the analysis.|The statistical analysis assessed changes in facial melanin index after serum application using repeated measures ANOVA. This method evaluated differences across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants, accounting for the correlated nature of repeated measures.||||1.000
91720977|NCT01013753|183334661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.409|0.645|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.645|0.409|<0.0001
91720978|NCT01013753|183334661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.572|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.453|0.692|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.692|0.453|<0.0001
91720979|NCT01013753|183334661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.54|0.781|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.781|0.540|<0.0001
91720980|NCT01013753|183334661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.451|0.689|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.689|0.451|<0.0001
91720981|NCT01013753|183334662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.168|0.436|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.436|0.168|<0.0001
91687954|NCT05724589|183268646|SUPERIORITY|A descriptive analysis was performed. No hypothesis testing or power calculation was conducted for this outcome.|percentage of participants at week 16|44.0||||1|TWO_SIDED|||||The p-value reflects descriptive analysis of SGAIS improvement scores; no statistical testing for significance was conducted.|Descriptive|The evaluation involved categorical SGAIS ratings assigned by two independent dermatologists.|This estimate reflects the proportion of participants rated as showing mild improvement on the SGAIS at Week 16, as detailed in the tabular data.|Improvement in facial appearance was assessed using the Subject Global Aesthetic Improvement Scale (SGAIS), rated independently by two board-certified dermatologists at multiple time points (8, 12, and 16 weeks).||||1.000
91687955|NCT05724589|183268647|SUPERIORITY|Descriptive summary statistics were used to report satisfaction at multiple time points. No inferential testing was performed.|percentage of participants at week 16|75.0|||||TWO_SIDED||||||Descriptive|No formal statistical hypothesis testing was performed.|The estimated percentage reflects participants who reported a satisfaction score of 2 or 3 at week 16.|"Satisfaction was assessed at weeks 8, 12, and 16 using a quartile scale:~0 = Unsatisfied, 1 = Slightly satisfied, 2 = Satisfied, 3 = Very satisfied. One participant was lost to follow-up after week 12."||||
91687956|NCT05724589|183268648|SUPERIORITY|This was a descriptive safety analysis. No inferential hypothesis testing was conducted.|Percentage adverse events by week 16|0.0|||||TWO_SIDED||||||Descriptive|No formal statistical test was conducted.|Descriptive summaries of adverse event incidence are reported in the results tables.|The analysis population includes 28 participants. One subject was lost to follow-up at week 12. Adverse events were assessed through video calls at weeks 2 and 4, and in-person visits at 2, 3, and 4 months.||||
91687957|NCT04700137|183268664|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.31|TWO_SIDED|95.0|-3.0|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among patients by intervention arm at follow-up (6 months).||1.0|-3.0|0.31
91687958|NCT04700137|183268664|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.83|TWO_SIDED|95.0|-1.8|2.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among healthcare providers/staff by intervention arm at follow-up (6 months).||2.2|-1.8|0.83
91687959|NCT04700137|183268665|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.5||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among patients by intervention arm at follow-up (6 months).||0.5|0.0|0.05
91687960|NCT04700137|183268665|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2|TWO_SIDED|95.0|-0.4|0.1||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months).||0.1|-0.4|0.2
91687961|NCT04700137|183268666|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.45|TWO_SIDED|95.0|-1.5|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among patients by intervention arm at follow-up (6 months).||0.7|-1.5|0.45
91687962|NCT04700137|183268666|SUPERIORITY||Median Difference (Final Values)|0.3||||0.51|TWO_SIDED|95.0|-0.7|1.3||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.3|-0.7|0.51
91687963|NCT04700137|183268667|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.54|TWO_SIDED|95.0|-1.3|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among patients by intervention arm at follow-up (6 months).||0.7|-1.3|0.54
91527676|NCT01976364|182930491|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-0.82|2.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.73|-0.82|
91488416|NCT02390908|182849006|SUPERIORITY||Slope|-0.03||||0.79|TWO_SIDED|95.0|-0.24|0.18||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.18|-0.24|0.79
91488417|NCT02390908|182849006|SUPERIORITY||Slope|-0.12||||0.57|TWO_SIDED|95.0|-0.53|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.53|0.57
91488418|NCT02390908|182849006|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.35|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to the No-Treatment EMR Control.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.35|0.97
91488419|NCT02390908|182849006|SUPERIORITY||Slope|0.07||||0.41|TWO_SIDED|95.0|-0.1|0.24||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.24|-0.10|0.41
91488420|NCT02390908|182849006|SUPERIORITY||Slope|0.06||||0.82|TWO_SIDED|95.0|-0.41|0.52||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.52|-0.41|0.82
91488421|NCT02390908|182849006|SUPERIORITY||Slope|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.53||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.53|-0.26|0.49
91488422|NCT02390908|182849006|SUPERIORITY||Slope|-0.33||||0.18|TWO_SIDED|95.0|-0.8|0.15||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.15|-0.80|0.18
91687964|NCT04700137|183268667|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED|95.0|0.1|2.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months).||2.0|0.1|0.04
91488423|NCT02390908|182849006|SUPERIORITY||Slope|0.02||||0.89|TWO_SIDED|95.0|-0.28|0.32||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.32|-0.28|0.89
91488424|NCT02390908|182849007|SUPERIORITY||Beta|1.92||||0.95|TWO_SIDED|95.0|-54.68|58.53||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||58.53|-54.68|0.95
91488425|NCT02390908|182849007|SUPERIORITY||Beta|23.99||||0.61|TWO_SIDED|95.0|-67.54|115.51||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||115.51|-67.54|0.61
91720982|NCT01013753|183334662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.429|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.297|0.561|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.561|0.297|<0.0001
91488426|NCT02390908|182849007|SUPERIORITY||Beta|-23.71||||0.48|TWO_SIDED|95.0|-88.82|41.4||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||41.40|-88.82|0.48
91488427|NCT02390908|182849007|SUPERIORITY||Beta|4.19||||0.88|TWO_SIDED|95.0|-49.76|58.14||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||58.14|-49.76|0.88
91687965|NCT04700137|183268668|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among patients.||1.7|-2.1|0.84
91720983|NCT01013753|183334662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.333|0.599|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.599|0.333|<0.0001
91687966|NCT04700137|183268668|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.18|TWO_SIDED|95.0|-0.7|3.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among healthcare providers/staff.||3.7|-0.7|0.18
91687967|NCT04700137|183268669|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.38|TWO_SIDED|95.0|-0.6|1.6||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among patients by intervention arm at follow-up (6 months).||1.6|-0.6|0.38
91687968|NCT04700137|183268669|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.81|TWO_SIDED|95.0|-0.8|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.0|-0.8|0.81
91687969|NCT04700137|183268669|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.73|TWO_SIDED|95.0|-2.6|1.8||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months).||1.8|-2.6|0.73
91687970|NCT04700137|183268669|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.24|TWO_SIDED|95.0|-0.8|3.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||3.2|-0.8|0.24
91687971|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|-5.6||||0.12|TWO_SIDED|95.0|-12.5|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among patients randomized to CC+ vs CC||1.4|-12.5|0.12
91687972|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|-6.1||||0.03|TWO_SIDED|95.0|-11.5|-0.7||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CC||-0.7|-11.5|0.03
91687973|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|-1.1||||0.83|TWO_SIDED|95.0|-10.7|8.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among patients randomized to CC+ vs CC||8.5|-10.7|0.83
91687974|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|2.2||||0.67|TWO_SIDED|95.0|-8.0|12.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CC||12.5|-8.0|0.67
91687975|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|2.9||||0.42|TWO_SIDED|95.0|-4.1|9.9||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CC||9.9|-4.1|0.42
91687976|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|-2.1||||0.53|TWO_SIDED|95.0|-8.7|4.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CC||4.5|-8.7|0.53
91720984|NCT01013753|183334662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.4|0.669|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.669|0.400|<0.0001
91720985|NCT01013753|183334662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.371|0.637|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.637|0.371|<0.0001
91720986|NCT01013753|183334663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.07||0.0002||95.0|0.127|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.401|0.127|0.0002
91687977|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|-2.5||||0.2|TWO_SIDED|95.0|-6.3|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among patients randomized to CC+ vs CC||1.4|-6.3|0.20
91687978|NCT04700137|183268671|SUPERIORITY||Risk Difference (RD)|-0.7||||0.62|TWO_SIDED|95.0|-3.4|2.0||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CC||2.0|-3.4|0.62
91687979|NCT04700137|183268672|SUPERIORITY||Risk Difference (RD)|-4.5||||0.41|TWO_SIDED|95.0|-15.4|6.3||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of patients attending mental healthcare appointments by intervention arm at follow-up (6 months).||6.3|-15.4|0.41
91720987|NCT01013753|183334663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.333|0.602|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.602|0.333|<0.0001
91720988|NCT01013753|183334663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.348|0.62|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.620|0.348|<0.0001
91488428|NCT02390908|182849007|SUPERIORITY||Slope|7.67||||0.59|TWO_SIDED|95.0|-19.88|35.21||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||35.21|-19.88|0.59
91687980|NCT04700137|183268672|SUPERIORITY||Risk Difference (RD)|5.5||||0.31|TWO_SIDED|95.0|-5.2|16.2||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months).||16.2|-5.2|0.31
91687981|NCT00125515|183268674|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||all statistical analysis were two tailed and employed an alpha significance level of 0.05.||||0.32
91687982|NCT03449446|183268677|SUPERIORITY||Difference in percentages|0.6||||0.9449|TWO_SIDED|95.0|-17.6|18.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted Mantel-Haenszel (MH) method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.8|-17.6|0.9449
91687983|NCT03449446|183268677|SUPERIORITY||Difference in percentages|0.4||||0.9646|TWO_SIDED|95.0|-17.6|18.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.4|-17.6|0.9646
91687984|NCT03449446|183268677|SUPERIORITY||Difference in percentages|3.7||||0.6219|TWO_SIDED|95.0|-10.9|18.3||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.3|-10.9|0.6219
91687985|NCT03449446|183268677|SUPERIORITY||Difference in percentages|8.8||||0.2554|TWO_SIDED|95.0|-6.4|24.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||24.1|-6.4|0.2554
91687986|NCT03449446|183268677|SUPERIORITY||Difference in percentages|10.8||||0.1658|TWO_SIDED|95.0|-4.5|26.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.1|-4.5|0.1658
91687987|NCT03449446|183268677|SUPERIORITY||Difference in percentages|3.2||||0.6963|TWO_SIDED|95.0|-12.9|19.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||19.4|-12.9|0.6963
91687988|NCT03449446|183268677|SUPERIORITY||Difference in percentages|10.0||||0.2441|TWO_SIDED|95.0|-6.8|26.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.8|-6.8|0.2441
91720989|NCT01013753|183334663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.624|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.487|0.761|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.761|0.487|<0.0001
91720990|NCT01013753|183334663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.447|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.311|0.583|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.583|0.311|<0.0001
91488429|NCT02390908|182849007|SUPERIORITY||Slope|-24.95||||0.24|TWO_SIDED|95.0|-66.78|16.88||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||16.88|-66.78|0.24
91488430|NCT02390908|182849007|SUPERIORITY||Slope|18.32||||0.15|TWO_SIDED|95.0|-6.63|43.27||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||43.27|-6.63|0.15
91488431|NCT02390908|182849007|SUPERIORITY||Slope|10.27||||0.33|TWO_SIDED|95.0|-10.2|30.74||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||30.74|-10.20|0.33
91488432|NCT02390908|182849007|SUPERIORITY||Slope|6.42||||0.8|TWO_SIDED|95.0|-44.24|57.09||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||57.09|-44.24|0.80
91488433|NCT02390908|182849007|SUPERIORITY||Slope|-5.43||||0.89|TWO_SIDED|95.0|-85.47|74.61||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||74.61|-85.47|0.89
91488434|NCT02390908|182849007|SUPERIORITY||Slope|1.16||||0.97|TWO_SIDED|95.0|-60.61|62.94||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||62.94|-60.61|0.97
91687989|NCT03449446|183268677|SUPERIORITY||Difference in percentages|5.2||||0.5229|TWO_SIDED|95.0|-10.7|21.0||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||21.0|-10.7|0.5229
91687990|NCT03449446|183268677|SUPERIORITY||Difference in percentages|10.4||||0.2149|TWO_SIDED|95.0|-6.0|26.9||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.9|-6.0|0.2149
91687991|NCT03048552|183268691|SUPERIORITY|||||||0.148|||||||Fisher Exact|||||||0.148
91687992|NCT03048552|183268692|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
91687993|NCT03048552|183268693|SUPERIORITY|||||||0.818|||||||Fisher Exact|||||||0.818
91687994|NCT03048552|183268695|SUPERIORITY|||||||0.625|||||||Fisher Exact|||||||0.625
91687995|NCT03180645|183268697|OTHER||Least square (LS) mean difference|-1.07||||0.0638|TWO_SIDED|95.0|-2.21|0.06|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of the face as fixed effects and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline minus the second named treatment adjusted mean change from baseline.|||0.06|-2.21|0.0638
91687996|NCT04208750|183268709|OTHER|Difference between independent proportions||||||||||||||||Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions|For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.|||
91687997|NCT02201277|183268710|SUPERIORITY|||||||1|||||||t-test, 2 sided|||A Fisher's exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.||||1.0
91687998|NCT02201277|183268710|EQUIVALENCE|rate of penetration||||||1|||||||t-test, 1 sided|||||||1.0
91687999|NCT02730663|183268718|NON_INFERIORITY|The number and percentage of patients who achieved clinical success at the time of stent removal are presented. A one-sided 97.5% confidence interval is to be calculated to confirm the degree of non-inferiority for the reference value (96%) and the difference (Investigational device - reference value) and if the lower limit of the confidence interval is -10% or higher, the noninferiority will be considered to be confirmed.|Reference value|-0.07||||0.05|ONE_SIDED|97.5||||A two-tail test was performed for statistics at a significance level of 0.05 unless otherwise specified.|t-test, 2 sided|||The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.||||0.05
91688000|NCT00866359|183268725|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.9|-2.4|<0.0001
91688001|NCT00866359|183268726|SUPERIORITY_OR_OTHER_LEGACY||Least Squares mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-35.5|-18.0|||ANCOVA||Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.|||-18.0|-35.5|<0.0001
91688002|NCT00866359|183268729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-90.07|||<|0.0001|TWO_SIDED|95.0|-125.32|-54.82||The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.|ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-54.82|-125.32|<0.0001
91688003|NCT00866359|183268732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0007|TWO_SIDED|95.0|-2.7|-0.8|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.8|-2.7|0.0007
91688004|NCT00866359|183268733|SUPERIORITY_OR_OTHER_LEGACY||adjusted difference (percentage)|39.1|||<|0.0001|TWO_SIDED|95.0|23.6|54.5|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test adjusting for gender.|Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.|||54.5|23.6|<0.0001
91688005|NCT00866359|183268734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0007|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA||Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.|||-0.5|-1.7|0.0007
91688006|NCT01625091|183268749|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
91688007|NCT01625091|183268750|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91688008|NCT01625091|183268751|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
91688009|NCT01625091|183268752|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
91688010|NCT04182334|183268771|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
91688011|NCT04182334|183268772|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||||||0.995
91720991|NCT01013753|183334664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.012|STANDARD_ERROR_OF_MEAN|3.671|<|0.0001||95.0|14.802|29.223|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||29.223|14.802|<0.0001
91488435|NCT02390908|182849007|SUPERIORITY||Slope|-38.4||||0.07|TWO_SIDED|95.0|-79.51|2.72||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||2.72|-79.51|0.07
91688012|NCT04182334|183268773|SUPERIORITY|||||||0.674|||||||Mixed Models Analysis|||||||0.674
91688013|NCT04182334|183268774|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||||||0.326
91688014|NCT04182334|183268775|SUPERIORITY|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||||||0.463
91688015|NCT04182334|183268776|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
91688016|NCT04182334|183268777|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
91688017|NCT04182334|183268778|SUPERIORITY|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
91688018|NCT04182334|183268779|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
91688019|NCT04182334|183268780|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
91688020|NCT04917861|183268788|OTHER||Geometric Mean Ratio (GMR)|7.002|||||TWO_SIDED|95.0|5.451|8.992|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||8.992|5.451|
91688021|NCT04917861|183268788|OTHER||GMR|7.123|||||TWO_SIDED|95.0|5.467|9.279|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||9.279|5.467|
91688022|NCT04917861|183268788|OTHER||GMR|2.674|||||TWO_SIDED|95.0|1.961|3.646|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.646|1.961|
91688023|NCT04917861|183268788|OTHER||GMR|7.208|||||TWO_SIDED|95.0|5.428|9.571|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||9.571|5.428|
91688024|NCT04917861|183268788|OTHER||GMR|7.979|||||TWO_SIDED|95.0|6.106|10.425|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||10.425|6.106|
91688025|NCT04917861|183268788|OTHER||GMR|1.516|||||TWO_SIDED|95.0|1.229|1.869|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||1.869|1.229|
91688026|NCT04917861|183268788|OTHER||GMR|6.785|||||TWO_SIDED|95.0|4.562|10.092|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||10.092|4.562|
91688027|NCT04917861|183268788|OTHER||GMR|6.319|||||TWO_SIDED|95.0|4.03|9.909|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||9.909|4.030|
91688028|NCT04917861|183268788|OTHER||GMR|7.028|||||TWO_SIDED|95.0|4.056|12.18|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||12.180|4.056|
91688029|NCT04917861|183268789|OTHER||GMR|5.312|||||TWO_SIDED|95.0|4.149|6.802|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.802|4.149|
91688030|NCT04917861|183268789|OTHER||GMR|5.346|||||TWO_SIDED|95.0|4.128|6.922|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.922|4.128|
91688031|NCT04917861|183268789|OTHER||GMR|2.325|||||TWO_SIDED|95.0|1.721|3.14|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.140|1.721|
91688032|NCT04917861|183268789|OTHER||GMR|4.221|||||TWO_SIDED|95.0|3.322|5.363|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||5.363|3.322|
91688033|NCT04917861|183268789|OTHER||GMR|5.3|||||TWO_SIDED|95.0|4.243|6.62|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||6.620|4.243|
91688034|NCT04917861|183268789|OTHER||GMR|1.206|||||TWO_SIDED|95.0|1.033|1.407|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||1.407|1.033|
91688035|NCT04917861|183268789|OTHER||GMR|6.493|||||TWO_SIDED|95.0|4.358|9.674|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||9.674|4.358|
91688036|NCT04917861|183268789|OTHER||GMR|5.452|||||TWO_SIDED|95.0|3.43|8.665|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||8.665|3.430|
91688037|NCT04917861|183268789|OTHER||GMR|6.804|||||TWO_SIDED|95.0|3.928|11.784|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||11.784|3.928|
91688038|NCT04917861|183268790|OTHER||percentage difference|76.69|||||TWO_SIDED|95.0|69.1|82.68|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||82.68|69.10|
91688039|NCT04917861|183268790|OTHER||percentage difference|77.8|||||TWO_SIDED|95.0|70.29|83.67|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||83.67|70.29|
91688040|NCT04917861|183268790|OTHER||percentage difference|35.58|||||TWO_SIDED|95.0|27.47|43.74|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||43.74|27.47|
91688041|NCT04917861|183268790|OTHER||percentage difference|86.11|||||TWO_SIDED|95.0|76.25|92.29|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||92.29|76.25|
91688042|NCT04917861|183268790|OTHER||percentage difference|87.65|||||TWO_SIDED|95.0|78.71|93.17|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||93.17|78.71|
91720992|NCT01013753|183334664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.022|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001||95.0|21.931|36.114|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||36.114|21.931|<0.0001
91720993|NCT01013753|183334664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.887|STANDARD_ERROR_OF_MEAN|3.631|<|0.0001||95.0|20.755|35.019|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.019|20.755|<0.0001
91720994|NCT01013753|183334664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.935|STANDARD_ERROR_OF_MEAN|3.668|<|0.0001||95.0|25.73|40.139|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||40.139|25.730|<0.0001
91720995|NCT01013753|183334664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.528|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001||95.0|16.371|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||30.686|16.371|<0.0001
91720996|NCT01013753|183334665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001||95.0|7.77|22.071|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||22.071|7.770|<0.0001
91488436|NCT02390908|182849008|SUPERIORITY||Beta|-7.87||||0.22|TWO_SIDED|95.0|-20.52|4.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||4.78|-20.52|0.22
91488437|NCT02390908|182849008|SUPERIORITY||Beta|10.29||||0.22|TWO_SIDED|95.0|-6.25|26.82||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||26.82|-6.25|0.22
91688043|NCT04917861|183268790|OTHER||percentage difference|20.43|||||TWO_SIDED|95.0|13.47|29.75|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||29.75|13.47|
91688044|NCT04917861|183268790|OTHER||percentage difference|67.72|||||TWO_SIDED|95.0|55.69|77.07|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.07|55.69|
91720997|NCT01013753|183334665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.834|STANDARD_ERROR_OF_MEAN|3.58|<|0.0001||95.0|17.801|31.866|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||31.866|17.801|<0.0001
91720998|NCT01013753|183334665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.613|STANDARD_ERROR_OF_MEAN|3.601|<|0.0001||95.0|16.539|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||30.686|16.539|<0.0001
91720999|NCT01013753|183334665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.449|STANDARD_ERROR_OF_MEAN|3.637|<|0.0001||95.0|21.305|35.594|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||35.594|21.305|<0.0001
91721000|NCT01013753|183334665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.439|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001||95.0|13.341|27.538|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||27.538|13.341|<0.0001
91721001|NCT01013753|183334666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.994|STANDARD_ERROR_OF_MEAN|0.507|<|0.0001||95.0|-2.989|-0.999|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.999|-2.989|<0.0001
91488438|NCT02390908|182849008|SUPERIORITY||Beta|-0.27||||0.96|TWO_SIDED|95.0|-11.63|11.08||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||11.08|-11.63|0.96
91488439|NCT02390908|182849008|SUPERIORITY||Slope|6.34||||0.03|TWO_SIDED|95.0|0.72|11.97||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.97|0.72|0.03
91688045|NCT04917861|183268790|OTHER||percentage difference|67.81|||||TWO_SIDED|95.0|55.36|77.44|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.44|55.36|
91688046|NCT04917861|183268790|OTHER||percentage difference|57.53|||||TWO_SIDED|95.0|43.81|69.08|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||69.08|43.81|
91688047|NCT04917861|183268791|OTHER||percentage difference|75.46|||||TWO_SIDED|95.0|68.12|81.49|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.49|68.12|
91688048|NCT04917861|183268791|OTHER||percentage difference|75.32|||||TWO_SIDED|95.0|67.94|81.38|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.38|67.94|
91688049|NCT04917861|183268791|OTHER||percentage difference|31.29|||||TWO_SIDED|95.0|24.23|38.96|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||38.96|24.23|
91688050|NCT04917861|183268791|OTHER||percentage difference|77.78|||||TWO_SIDED|95.0|66.87|85.85|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||85.85|66.87|
91688051|NCT04917861|183268791|OTHER||percentage difference|82.72|||||TWO_SIDED|95.0|73.02|89.43|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||89.43|73.02|
91721002|NCT01013753|183334666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.095|STANDARD_ERROR_OF_MEAN|0.498|<|0.0001||95.0|-3.073|-1.116|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-1.116|-3.073|<0.0001
91721003|NCT01013753|183334666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|0.503||0.0003||95.0|-2.824|-0.849|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.849|-2.824|0.0003
91721004|NCT01013753|183334666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.789|STANDARD_ERROR_OF_MEAN|0.506||0.0004||95.0|-2.783|-0.795|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.795|-2.783|0.0004
91721005|NCT01013753|183334666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.503||0.0118||95.0|-2.258|-0.283|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.283|-2.258|0.0118
91721006|NCT01013753|183334667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.025||0.0002||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.141|0.045|0.0002
91721007|NCT01013753|183334667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.081|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.081|<0.0001
91721008|NCT01013753|183334667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.087|<0.0001
91488440|NCT02390908|182849008|SUPERIORITY||Slope|3.35||||0.42|TWO_SIDED|95.0|-4.78|11.47||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.47|-4.78|0.42
91721009|NCT01013753|183334667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.121|0.217|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.217|0.121|<0.0001
91721010|NCT01013753|183334667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.141|0.045|0.0001
91527677|NCT01976364|182930492|OTHER||LS mean difference|0.78|||||TWO_SIDED|95.0|-1.27|2.82||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.82|-1.27|
91721011|NCT01013753|183334668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0362||95.0|0.003|0.097|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.097|0.003|0.0362
91721012|NCT01013753|183334668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.023||0.0006||95.0|0.035|0.127|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.127|0.035|0.0006
91721013|NCT01013753|183334668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.024||0.0002||95.0|0.042|0.135|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.135|0.042|0.0002
91721014|NCT01013753|183334668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.07|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.164|0.070|<0.0001
91721015|NCT01013753|183334668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.024||0.001||95.0|0.032|0.125|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.125|0.032|0.0010
91721016|NCT01013753|183334669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.77|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.282|-0.770|<0.0001
91721017|NCT01013753|183334669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|STANDARD_ERROR_OF_MEAN|0.122||0.0004||95.0|-0.671|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.671|0.0004
91488441|NCT02390908|182849008|SUPERIORITY||Slope|0.34||||0.91|TWO_SIDED|95.0|-5.85|6.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||6.54|-5.85|0.91
91688052|NCT04917861|183268791|OTHER||percentage difference|9.68|||||TWO_SIDED|95.0|4.63|17.41|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||17.41|4.63|
91721018|NCT01013753|183334669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.478|STANDARD_ERROR_OF_MEAN|0.123||0.0001||95.0|-0.72|-0.237|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.237|-0.720|0.0001
91721019|NCT01013753|183334669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.901|-0.413|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.413|-0.901|<0.0001
91721020|NCT01013753|183334669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.449|STANDARD_ERROR_OF_MEAN|0.123||0.0003||95.0|-0.691|-0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.207|-0.691|0.0003
91721021|NCT01013753|183334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.289|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.178|0.4|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.400|0.178|<0.0001
91721022|NCT01013753|183334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.056||0.0002||95.0|0.099|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.318|0.099|0.0002
91721023|NCT01013753|183334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.151|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.374|0.151|<0.0001
91721024|NCT01013753|183334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.205|0.429|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.429|0.205|<0.0001
91721025|NCT01013753|183334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.315|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.203|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.426|0.203|<0.0001
91721026|NCT01013753|183334675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.432|-0.21|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.210|-0.432|<0.0001
91721027|NCT01013753|183334675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.403|-0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.184|-0.403|<0.0001
91721028|NCT01013753|183334675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.436|-0.215|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.215|-0.436|<0.0001
91721029|NCT01013753|183334675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.394|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.505|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.282|-0.505|<0.0001
91721030|NCT01013753|183334675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.457|-0.235|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.235|-0.457|<0.0001
91721031|NCT01013753|183334676|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6187||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.981|0.6187
91721032|NCT01013753|183334676|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6022||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.011|0.981|0.6022
91721033|NCT01013753|183334676|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.8641||95.0|0.984|1.014|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.014|0.984|0.8641
91721034|NCT01013753|183334676|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.998||||0.7664||95.0|0.983|1.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.013|0.983|0.7664
91721035|NCT01013753|183334676|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.003||||0.6757||95.0|0.988|1.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.018|0.988|0.6757
91721036|NCT01013753|183334677|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.993||||0.4423||95.0|0.975|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.975|0.4423
91688053|NCT04917861|183268791|OTHER||percentage difference|72.39|||||TWO_SIDED|95.0|61.56|80.83|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||80.83|61.56|
91688054|NCT04917861|183268791|OTHER||percentage difference|67.29|||||TWO_SIDED|95.0|55.72|76.78|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||76.78|55.72|
91688055|NCT04917861|183268791|OTHER||percentage difference|63.35|||||TWO_SIDED|95.0|50.75|74.0|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||74.00|50.75|
91721037|NCT01013753|183334677|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.979||||0.0218||95.0|0.962|0.997|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.997|0.962|0.0218
91527678|NCT01976364|182930492|OTHER||LS mean difference|-0.38|||||TWO_SIDED|95.0|-2.46|1.71||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.71|-2.46|
91688056|NCT00720382|183268816|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Overall baseline score||||0.783
91688057|NCT00720382|183268816|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 1||||0.971
91688058|NCT00720382|183268816|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 3||||0.206
91688059|NCT00720382|183268816|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 6||||0.111
91688060|NCT00720382|183268816|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 9||||0.181
91688061|NCT00720382|183268816|SUPERIORITY_OR_OTHER|||||||0.037|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from Baseline to Month 12/Early Term||||0.037
91688062|NCT04467840|183268824|SUPERIORITY||Risk Difference (RD)|3.86||||0.391|TWO_SIDED|95.0|-4.93|12.65||The threshold for statistical significance was p = 0.05|Cochran-Mantel-Haenszel||Opaganib - Placebo|||12.65|-4.93|0.391
91688063|NCT04467840|183268825|SUPERIORITY||Risk Difference (RD)|3.91||||0.38|TWO_SIDED|95.0|-4.78|12.6||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||12.60|-4.78|0.380
91688064|NCT04467840|183268826|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.231|TWO_SIDED|95.0|0.91|1.45||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.45|0.91|0.231
91688065|NCT04467840|183268827|SUPERIORITY||Hazard Ratio, log|1.08||||0.472|TWO_SIDED|95.0|0.87|1.33||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.33|0.87|0.472
91688066|NCT04467840|183268828|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.521|TWO_SIDED|95.0|0.846|1.378||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.378|0.846|0.521
91688067|NCT04467840|183268829|SUPERIORITY||Risk Difference (RD)|-1.51||||0.701|TWO_SIDED|95.0|-9.19|6.18||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||6.18|-9.19|0.701
91688068|NCT04467840|183268830|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Hazard Ratio (HR)|1.34||||0.043|TWO_SIDED|95.0|0.99|1.82|||Log Rank|||||1.82|0.99|0.043
91688069|NCT04467840|183268831|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Risk Difference (RD)|8.3||||0.118|TWO_SIDED|95.0|-2.05|18.65|||Cochran-Mantel-Haenszel|||||18.65|-2.05|0.118
91688070|NCT04467840|183268835|SUPERIORITY||Risk Difference (RD)|12.28||||0.033|TWO_SIDED|95.0|1.06|23.5||unadjusted p-value|Cochran-Mantel-Haenszel|||||23.50|1.06|0.033
91688071|NCT04467840|183268836|SUPERIORITY||Risk Difference (RD)|-4.75||||0.5|TWO_SIDED|95.0|-18.67|9.17|||Cochran-Mantel-Haenszel|||||9.17|-18.67|0.500
91688072|NCT04467840|183268837|SUPERIORITY||Risk Difference (RD)|12.75||||0.023|TWO_SIDED|95.0|1.9|23.6|||Cochran-Mantel-Haenszel|||||23.60|1.90|0.023
91688073|NCT04467840|183268838|SUPERIORITY||Risk Difference (RD)|-4.12||||0.561|TWO_SIDED|95.0|-18.07|9.82|||Cochran-Mantel-Haenszel|||||9.82|-18.07|0.561
91688074|NCT04467840|183268839|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.01|TWO_SIDED|95.0|1.07|1.93|||Log Rank|||||1.93|1.07|0.01
91688075|NCT04467840|183268840|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.545|TWO_SIDED|95.0|0.58|1.34|||Log Rank|||||1.34|0.58|0.545
91688076|NCT04467840|183268841|SUPERIORITY||Hazard Ratio (HR)|1.276||||0.1|TWO_SIDED|95.0|0.94|1.732|||Log Rank|||||1.732|0.940|0.100
91688077|NCT04467840|183268843|SUPERIORITY||Risk Difference (RD)|-10.5||||0.012|TWO_SIDED|95.0|-18.44|-2.57|||Cochran-Mantel-Haenszel|||||-2.57|-18.44|0.012
91688078|NCT04467840|183268844|SUPERIORITY||Risk Difference (RD)|7.2||||0.304|TWO_SIDED|95.0|-6.46|20.86|||Cochran-Mantel-Haenszel|||||20.86|-6.46|0.304
91688079|NCT04467840|183268845|SUPERIORITY||Risk Difference (RD)|-9.22||||0.019|TWO_SIDED|95.0|-16.63|-1.8|||Cochran-Mantel-Haenszel|||||-1.80|-16.63|0.019
91688080|NCT04467840|183268846|SUPERIORITY||Risk Difference (RD)|7.37||||0.273|TWO_SIDED|95.0|-5.66|20.39|||Cochran-Mantel-Haenszel|||||20.39|-5.66|0.273
91688081|NCT06418529|183268849|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
91688082|NCT06418529|183268850|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.07||||||||1.07|0.83|
91688083|NCT06418529|183268851|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.79|0.99||||||||0.99|0.79|
91688084|NCT06418529|183268852|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.79|1.04||||||||1.04|0.79|
91688085|NCT06418529|183268853|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||||1.05|0.81|
91688086|NCT06418529|183268854|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09||||||||1.09|0.79|
91688087|NCT02719184|183268910|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-2.89|STANDARD_ERROR_OF_MEAN|1.23||0.0202|TWO_SIDED|95.0|-5.32|-0.45|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||-0.45|-5.32|0.0202
91721038|NCT01013753|183334677|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.977||||0.0109||95.0|0.96|0.995|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.995|0.960|0.0109
91721039|NCT01013753|183334677|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0283||95.0|0.962|0.998|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.998|0.962|0.0283
91721040|NCT01013753|183334677|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.3085||95.0|0.973|1.009|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.009|0.973|0.3085
91721041|NCT01013753|183334678|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.9112||95.0|0.984|1.015|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.015|0.984|0.9112
91721042|NCT01013753|183334678|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.992||||0.2955||95.0|0.977|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.007|0.977|0.2955
91721043|NCT01013753|183334678|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.987||||0.1029||95.0|0.973|1.003|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.003|0.973|0.1029
91488442|NCT02390908|182849009|SUPERIORITY||Beta|3.19||||0.02|TWO_SIDED|95.0|0.61|5.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||5.78|0.61|0.02
91488443|NCT02390908|182849009|SUPERIORITY||Beta|-0.86||||0.63|TWO_SIDED|95.0|-4.33|2.61||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||2.61|-4.33|0.63
91488444|NCT02390908|182849009|SUPERIORITY||Beta|4.17||||0.02|TWO_SIDED|95.0|0.8|7.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||7.54|0.80|0.02
91721044|NCT01013753|183334678|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.2552||95.0|0.975|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.007|0.975|0.2552
91721045|NCT01013753|183334678|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.994||||0.4803||95.0|0.979|1.01|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.010|0.979|0.4803
91721046|NCT00621530|183334701|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.||||=0.94
91721047|NCT00621530|183334702|SUPERIORITY||||||=|0.78|||||||ANOVA|Repeated measures ANOVA||||||=0.78
91721048|NCT00621530|183334703|SUPERIORITY||||||=|0.87|||||||ANOVA|Repeated measures ANOVA||||||=0.87
91721049|NCT00621530|183334704|SUPERIORITY||||||=|0.66|||||||ANOVA|Repeated measures ANOVA||||||=0.66
91721050|NCT00621530|183334705|SUPERIORITY||||||=|0.83|||||||ANOVA|Repeated measures ANOVA||||||=0.83
91721051|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.57|1.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.76|0.57|
91721052|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.52|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.94|0.52|
91721053|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.58|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.98|0.58|
91721054|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.53|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|0.53|
91488445|NCT02390908|182849009|SUPERIORITY||Slope|-0.4||||0.46|TWO_SIDED|95.0|-1.47|0.67||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.67|-1.47|0.46
91721055|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.57|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||0.98|0.57|
91721056|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.98|0.61|
91688088|NCT02719184|183268910|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.78|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|-7.36|-2.19|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.|||-2.19|-7.36|0.0003
91688089|NCT02719184|183268910|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.47|STANDARD_ERROR_OF_MEAN|1.51||0.0033|TWO_SIDED|95.0|-7.44|-1.5|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.50|-7.44|0.0033
91488446|NCT02390908|182849009|SUPERIORITY||Slope|-0.29||||0.5|TWO_SIDED|95.0|-1.12|0.55||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.55|-1.12|0.50
91488447|NCT02390908|182849009|SUPERIORITY||Slope|-0.35||||0.43|TWO_SIDED|95.0|-1.23|0.52||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.52|-1.23|0.43
91488448|NCT03725852|182849100|SUPERIORITY||Least square (LS) mean difference|42.33|STANDARD_ERROR_OF_MEAN|61.483||0.495|TWO_SIDED|95.0|-81.84|166.49||P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.|ANCOVA|||Change at Week 26||166.49|-81.84|0.495
91488449|NCT03725852|182849101|SUPERIORITY||Difference in Percentage|1.7|||||TWO_SIDED|95.0|-17.3|24.5|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs||24.5|-17.3|
91488450|NCT03725852|182849101|SUPERIORITY||Difference in Percentage|15.7|||||TWO_SIDED|95.0|-3.0|30.7|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|Serious TEAEs||30.7|-3.0|
91488451|NCT03725852|182849101|SUPERIORITY||Difference in Percentage|31.4|||||TWO_SIDED|95.0|8.2|49.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs related to study drug||49.4|8.2|
91688090|NCT02719184|183268910|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-5.86|STANDARD_ERROR_OF_MEAN|2.74||0.0334|TWO_SIDED|95.0|-11.26|-0.47|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-0.47|-11.26|0.0334
91688091|NCT02719184|183268911|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|14.4||0.9306|TWO_SIDED|95.0|-27.2|29.7|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||29.7|-27.2|0.9306
91721057|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.53|1.51|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.51|0.53|
91721058|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.89|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.89|0.38|
91488452|NCT03725852|182849101|SUPERIORITY||Difference in Percentage|22.2|||||TWO_SIDED|95.0|6.7|36.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs leading to study drug discontinuation||36.4|6.7|
91488453|NCT03725852|182849102|SUPERIORITY|||||||0.397|||||||Log Rank|||All-cause deaths||||0.397
91488454|NCT03725852|182849102|SUPERIORITY|||||||0.397|||||||Log Rank|||Respiratory-related deaths||||0.397
91488455|NCT03725852|182849102|SUPERIORITY|||||||0.131|||||||Log Rank|||All-cause hospitalizations||||0.131
91488456|NCT03725852|182849102|SUPERIORITY|||||||0.762|||||||Log Rank|||Respiratory-related hospitalizations||||0.762
91488457|NCT03725852|182849103|SUPERIORITY||Weighted LS mean difference|-9.11|STANDARD_ERROR_OF_MEAN|15.713||0.565|TWO_SIDED|95.0|-40.87|22.64||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.|ANCOVA|||Change at Week 26||22.64|-40.87|0.565
91488458|NCT03725852|182849104|SUPERIORITY||Weighted LS mean difference.|-1.58|STANDARD_ERROR_OF_MEAN|3.71||0.673|TWO_SIDED|95.0|-9.06|5.91||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26||5.91|-9.06|0.673
91688092|NCT02719184|183268911|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-19.2|STANDARD_ERROR_OF_MEAN|14.9||0.1983|TWO_SIDED|95.0|-48.5|10.1|||Random slope and intercept model|The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.||||10.1|-48.5|0.1983
91688093|NCT02719184|183268911|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-33.6|STANDARD_ERROR_OF_MEAN|16.1||0.0381|TWO_SIDED|95.0|-65.4|-1.9|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.9|-65.4|0.0381
91721059|NCT02081807|183334713|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.5|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.50|
91488459|NCT03725852|182849105|SUPERIORITY||Weighted LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|4.591||0.875|TWO_SIDED|95.0|-9.98|8.53||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Symptoms score||8.53|-9.98|0.875
91488460|NCT03725852|182849105|SUPERIORITY||Weighted LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.038||0.416|TWO_SIDED|95.0|-14.29|6.02||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Activity score||6.02|-14.29|0.416
91488461|NCT03725852|182849105|SUPERIORITY||Weighted LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.029||0.961|TWO_SIDED|95.0|-8.32|7.92||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Impacts score||7.92|-8.32|0.961
91488462|NCT03725852|182849106|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91488463|NCT02256072|182849131|SUPERIORITY_OR_OTHER||Slope|1.25|STANDARD_ERROR_OF_MEAN|0.45||0.0054|TWO_SIDED|95.0|0.37|2.12|||ANCOVA|||H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.||2.12|0.37|0.0054
91688094|NCT02719184|183268911|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-61.8|STANDARD_ERROR_OF_MEAN|30.3||0.0419|TWO_SIDED|95.0|-121.3|-2.3|||Random slope and intercept model||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-2.3|-121.3|0.0419
91688095|NCT02556801|183268954|SUPERIORITY||Test statistic|1.823||||0.057|ONE_SIDED||||||MCP-Mod Method|The primary dose-response analysis was performed by applying linear, Emax, logistic and exponential models.The p-value was based on Emax model.||||||0.057
91688096|NCT02556801|183268954|SUPERIORITY||Treatment effect|-1.96|STANDARD_DEVIATION|1.17|||TWO_SIDED|90.0|-3.89|-0.03||||||||-0.03|-3.89|
91688097|NCT02556801|183268954|SUPERIORITY||Treatment effect|-1.83|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.72|0.06||||||||0.06|-3.72|
91721060|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.38|0.69|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.69|0.38|
91721061|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.86|0.68|
91721062|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.65|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.65|
91721063|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.88|1.26|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.26|0.88|
91688098|NCT02556801|183268954|SUPERIORITY||Treatment effect|-2.33|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-4.23|-0.43||||||||-0.43|-4.23|
91688099|NCT02556801|183268955|SUPERIORITY||Treatment effect|-1.92|STANDARD_ERROR_OF_MEAN|1.17|=|0.051|TWO_SIDED|90.0|-3.85|0.01|||Mixed Models Analysis|||||0.01|-3.85|=0.051
91688100|NCT02556801|183268955|SUPERIORITY||Treatment effect|-1.79|STANDARD_ERROR_OF_MEAN|1.14||0.059|TWO_SIDED|90.0|-3.68|0.1|||Mixed Models Analysis|||||0.10|-3.68|0.059
91688101|NCT02556801|183268955|SUPERIORITY||Treatment effect|-2.3|STANDARD_ERROR_OF_MEAN|1.15||0.024|TWO_SIDED|90.0|-4.2|-0.4|||Mixed Models Analysis|||||-0.40|-4.20|0.024
91688102|NCT02556801|183268956|SUPERIORITY||Treatment effect|-0.6|STANDARD_ERROR_OF_MEAN|1.08||0.291|TWO_SIDED|90.0|-2.39|1.19|||Mixed Models Analysis|||||1.19|-2.39|0.291
91688103|NCT02556801|183268956|SUPERIORITY||Treatment effect|-1.84|STANDARD_ERROR_OF_MEAN|1.06|=|0.042|TWO_SIDED|90.0|-3.6|-0.09|||Mixed Models Analysis|||||-0.09|-3.60|=0.042
91688104|NCT02556801|183268956|SUPERIORITY||Treatment effect|-1.78|STANDARD_ERROR_OF_MEAN|1.08||0.05|TWO_SIDED|90.0|-3.56|0.0|||Mixed Models Analysis|||||0.00|-3.56|0.050
91688105|NCT02556801|183268957|SUPERIORITY||Treatment effect|-0.89|STANDARD_ERROR_OF_MEAN|0.63|=|0.079|TWO_SIDED|90.0|-1.93|0.15|||Mixed Models Analysis|||||0.15|-1.93|=0.079
91688106|NCT02556801|183268957|SUPERIORITY||Treatment effect|-0.88|STANDARD_ERROR_OF_MEAN|0.61|=|0.076|TWO_SIDED|90.0|-1.89|0.13|||Mixed Models Analysis|||||0.13|-1.89|=0.076
91688107|NCT02556801|183268957|SUPERIORITY||Treatment effect|-1.11|STANDARD_ERROR_OF_MEAN|0.62|=|0.038|TWO_SIDED|0.62|-2.13|-0.08|||Mixed Models Analysis|||||-0.08|-2.13|=0.038
91688108|NCT02556801|183268958|SUPERIORITY||Treatment effect|-0.07|STANDARD_ERROR_OF_MEAN|0.58|=|0.451|TWO_SIDED|90.0|-1.03|0.88|||Mixed Models Analysis|||||0.88|-1.03|=0.451
91688109|NCT02556801|183268958|SUPERIORITY||Treatment effect|-0.62|STANDARD_ERROR_OF_MEAN|0.56|=|0.137|TWO_SIDED|90.0|-1.55|0.32|||Mixed Models Analysis|||||0.32|-1.55|=0.137
91688110|NCT02556801|183268958|SUPERIORITY||Treatment effect|-0.5|STANDARD_ERROR_OF_MEAN|0.57|=|0.195|TWO_SIDED|90.0|-1.45|0.46|||Mixed Models Analysis|||||0.46|-1.45|=0.195
91688111|NCT02556801|183268959|SUPERIORITY||Treatment effect|-0.354|STANDARD_ERROR_OF_MEAN|0.183|=|0.028|TWO_SIDED|90.0|-0.657|-0.05|||ANOVA|||||-0.050|-0.657|=0.028
91688112|NCT02556801|183268959|SUPERIORITY||Treatment effect|-0.394|STANDARD_ERROR_OF_MEAN|0.186|=|0.018|TWO_SIDED|90.0|-0.702|-0.086|||ANOVA|||||-0.086|-0.702|=0.018
91688113|NCT02556801|183268959|SUPERIORITY||Treatment effect|-0.28|STANDARD_ERROR_OF_MEAN|0.182|=|0.063|TWO_SIDED|90.0|-0.581|0.021|||ANOVA|||||0.021|-0.581|=0.063
91488464|NCT02256072|182849132|SUPERIORITY_OR_OTHER||Slope|0.244|STANDARD_ERROR_OF_MEAN|0.123||0.0471|TWO_SIDED|||||P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.||||0.0471
91527097|NCT02969525|182929506|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|9.7|||<|0.001|TWO_SIDED|95.0|2.73|34.26||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||34.26|2.73|<0.001
91688114|NCT02556801|183268960|SUPERIORITY||Treatment effect|1.92|||<|0.001|TWO_SIDED|90.0|1.41|2.6|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||2.60|1.41|<0.001
91688115|NCT02556801|183268960|SUPERIORITY||Treatment effect|2.43|||<|0.001|TWO_SIDED|90.0|1.8|3.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.27|1.80|<0.001
91688116|NCT02556801|183268960|SUPERIORITY||Treatment effect|2.34|||<|0.001|TWO_SIDED|90.0|1.73|3.15|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.15|1.73|<0.001
91688117|NCT02556801|183268960|SUPERIORITY||Treatment effect|1.42||||0.029|TWO_SIDED|90.0|1.05|1.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.93|1.05|0.029
91688118|NCT02556801|183268960|SUPERIORITY||Treatment effect|1.67||||0.003|TWO_SIDED|90.0|1.24|2.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||2.25|1.24|0.003
91688119|NCT02556801|183268960|SUPERIORITY||Treatment effect|1.37||||0.042|TWO_SIDED|90.0|1.01|1.85|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.85|1.01|0.042
91721064|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||1.12|0.92|
91721065|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.94|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.12|0.94|
91721066|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.66|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.66|0.39|
91688120|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.11||||0.057|TWO_SIDED|90.0|1.0|1.23|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.23|1.00|0.057
91688121|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.29|||<|0.001|TWO_SIDED|90.0|1.17|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.43|1.17|<0.001
91688122|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.24|||<|0.001|TWO_SIDED|90.0|1.12|1.37|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.37|1.12|<0.001
91688123|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.23||||0.015|TWO_SIDED|90.0|1.05|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.45|1.05|0.015
91688124|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.6|||<|0.001|TWO_SIDED|90.0|1.37|1.87|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.87|1.37|<0.001
91688125|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.39|||<|0.001|TWO_SIDED|90.0|1.19|1.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.62|1.19|<0.001
91688126|NCT02556801|183268961|SUPERIORITY||Treatment effect|0.99||||0.341|TWO_SIDED|90.0|0.93|1.04|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.04|0.93|0.341
91688127|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.1||||0.003|TWO_SIDED|90.0|1.04|1.16|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.16|1.04|0.003
91688128|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.02||||0.269|TWO_SIDED|90.0|0.97|1.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.08|0.97|0.269
91688129|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.02||||0.312|TWO_SIDED|90.0|0.95|1.1|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.10|0.95|0.312
91688130|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.22|||<|0.001|TWO_SIDED|90.0|1.13|1.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.31|1.13|<0.001
91688131|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.11||||0.008|TWO_SIDED|90.0|1.03|1.2|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.20|1.03|0.008
91688132|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.04||||0.212|TWO_SIDED|90.0|0.96|1.14|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.14|0.96|0.212
91488465|NCT02256072|182849133|SUPERIORITY_OR_OTHER||Slope|0.075|STANDARD_ERROR_OF_MEAN|0.094||0.423|TWO_SIDED|||||p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.|The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.|H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.||||0.423
91527679|NCT01976364|182930492|OTHER||LS mean difference|-0.57|||||TWO_SIDED|95.0|-2.72|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-2.72|
91688133|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.16||||0.002|TWO_SIDED|90.0|1.07|1.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.27|1.07|0.002
91688134|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.15||||0.004|TWO_SIDED|90.0|1.06|1.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.25|1.06|0.004
91688135|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.09||||0.126|TWO_SIDED|90.0|0.96|1.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.24|0.96|0.126
91688136|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.28|||<|0.001|TWO_SIDED|90.0|1.13|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.45|1.13|<0.001
91688137|NCT02556801|183268961|SUPERIORITY||Treatment effect|1.26||||0.002|TWO_SIDED|90.0|1.11|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.43|1.11|0.002
91688138|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.33||||0.032|TWO_SIDED|90.0|1.03|1.7|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||1.70|1.03|0.032
91688139|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.15|||<|0.001|TWO_SIDED|90.0|1.68|2.74|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.74|1.68|<0.001
91688140|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.03|||<|0.001|TWO_SIDED|90.0|1.59|2.59|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.59|1.59|<0.001
91688141|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.48||||0.024|TWO_SIDED|90.0|1.07|2.06|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.06|1.07|0.024
91688142|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|2.09|3.98|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||3.98|2.09|<0.001
91688143|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.12|||<|0.001|TWO_SIDED|90.0|1.54|2.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.93|1.54|<0.001
91688144|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.18||||0.102|TWO_SIDED|90.0|0.95|1.47|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.47|0.95|0.102
91688145|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.99|||<|0.001|TWO_SIDED|90.0|1.61|2.46|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||2.46|1.61|<0.001
91688146|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.57|||<|0.001|TWO_SIDED|90.0|1.27|1.94|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.94|1.27|<0.001
91688147|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.39||||0.019|TWO_SIDED|90.0|1.07|1.81|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||1.81|1.07|0.019
91688148|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.38|||<|0.001|TWO_SIDED|90.0|1.84|3.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||3.08|1.84|<0.001
91688149|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.7|||<|0.001|TWO_SIDED|90.0|1.31|2.19|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||2.19|1.31|<0.001
91688150|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.52||||0.048|TWO_SIDED|90.0|1.01|2.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||2.31|1.01|0.048
91688151|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.35|||<|0.001|TWO_SIDED|90.0|1.56|3.53|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||3.53|1.56|<0.001
91688152|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.83|||<|0.001|TWO_SIDED|90.0|1.88|4.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||4.24|1.88|<0.001
91688153|NCT02556801|183268962|SUPERIORITY||Treatment effect|1.67||||0.04|TWO_SIDED|90.0|1.03|2.69|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||2.69|1.03|0.040
91688154|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.68|||<|0.001|TWO_SIDED|90.0|1.67|4.3|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.30|1.67|<0.001
91688155|NCT02556801|183268962|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|1.8|4.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.62|1.80|<0.001
91688156|NCT01339403|183268965|SUPERIORITY_OR_OTHER||Rate ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
91489405|NCT02484690|182851583|SUPERIORITY||Difference in Least Squares Means|1.22||||0.2256|TWO_SIDED|80.0|-0.07|2.52||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.52|-0.07|0.2256
91688157|NCT01339403|183268965|SUPERIORITY_OR_OTHER||Rate ratio|12.1|||<|0.001|TWO_SIDED|95.0|10.3|14.2|||Poisson Regression|||Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.2|10.3|<0.001
91688158|NCT01339403|183268965|SUPERIORITY_OR_OTHER||Rate ratio|3.4||||0.059|TWO_SIDED|95.0|1.0|12.3|||Poisson Regression|||Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.3|1.0|0.059
91688159|NCT01339403|183268965|SUPERIORITY_OR_OTHER||Rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.5|1.8|||Poisson Regression|||Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.8|1.5|<0.001
91688160|NCT01339403|183268965|SUPERIORITY_OR_OTHER||Rate Ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
91688161|NCT01339403|183268966|SUPERIORITY_OR_OTHER||Rate ratio|1.4|||<|0.001|TWO_SIDED|95.0|1.3|1.5|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.5|1.3|<0.001
91688162|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|65.7|||<|0.001|TWO_SIDED|95.0|57.1|75.7|||Poisson Regression|||Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||75.7|57.1|<0.001
91721067|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.49|0.68|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.68|0.49|
91721068|NCT02081807|183334714|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.64|0.49|
91527680|NCT01976364|182930492|OTHER||LS mean difference|0.28|||||TWO_SIDED|95.0|-1.81|2.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.36|-1.81|
91688163|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|428.5|||<|0.001|TWO_SIDED|95.0|292.2|628.5|||Poisson Regression|||Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||628.5|292.2|<0.001
91688164|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|8.7|||<|0.001|TWO_SIDED|95.0|7.9|9.5|||Poisson Regression|||Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.5|7.9|<0.001
91688165|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|97.1|||<|0.001|TWO_SIDED|95.0|75.5|124.8|||Poisson Regression|||Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||124.8|75.5|<0.001
91688166|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|60.2|||<|0.001|TWO_SIDED|95.0|48.3|74.9|||Poisson Regression|||Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||74.9|48.3|<0.001
91688167|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|98.4|||<|0.001|TWO_SIDED|95.0|70.8|136.8|||Poisson Regression|||Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||136.8|70.8|<0.001
91688168|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|189.5|||<|0.001|TWO_SIDED|95.0|112.3|319.5|||Poisson Regression|||Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||319.5|112.3|<0.001
91688169|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|5.2|7.4|||Poisson Regression|||Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||7.4|5.2|<0.001
91688170|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|594.5|||<|0.001|TWO_SIDED|95.0|146.5|2411.7|||Poisson Regression|||Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||2411.7|146.5|<0.001
91688171|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|10.6|||<|0.001|TWO_SIDED|95.0|7.8|14.4|||Poisson Regression|||Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.4|7.8|<0.001
91488466|NCT02256072|182849134|SUPERIORITY_OR_OTHER||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|||||p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.||||<0.0001
91721069|NCT02081807|183334715|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.11|0.69|
91721070|NCT02081807|183334715|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.02|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.02|0.66|
91721071|NCT02081807|183334715|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.88|0.47|
91721072|NCT02081807|183334716|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|1.03|3.3|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||3.30|1.03|
91721073|NCT02081807|183334716|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.65|1.71|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.71|0.65|
91488467|NCT00370071|182849177|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||In this single arm study, the number of newly active lesions per 3 months during treatment was compared to the number of newly active lesions during 3-month pre-treatment (Alternative hypothesis: Number of lesions is reduced during treatment with Interferon beta-1b). The sample size was calculated for the use of the one-sided Wilcoxon-Signed-Rank test at level 2.5% (Power of 90% - anticipating P(X\&lt;Y)=0.15 and allowing for 25% exclusion from Per Protocol Set).||||<0.0001
91488468|NCT00370071|182849178|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||<0.0001
91488469|NCT00370071|182849179|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||0.0017
91488470|NCT00370071|182849180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon-Signed-Rank test|One-sided p-value from Wilcoxon-Signed-Rank-Test for comparing the baseline visit to treatment visits||Lesion volume at Week 12. 38 subjects were evaluated.||||<0.0001
91721074|NCT02081807|183334716|OTHER||Hazard Ratio (HR)|0.31|||||TWO_SIDED|95.0|0.1|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.10|
91721075|NCT02081807|183334717|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.12|0.63|
91688172|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|51.5|||<|0.001|TWO_SIDED|95.0|30.3|87.5|||Poisson Regression|||Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||87.5|30.3|<0.001
91488471|NCT00370071|182849180|SUPERIORITY_OR_OTHER||||||=|0.0019|||||||Wilcoxon-Signed-Rank test|||Lesion volume at Week 24. 37 subjects were evaluated.||||=0.0019
91488472|NCT00310401|182849198|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Paired T Test|||Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors||||0.98
91488473|NCT00319501|182849203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.012|TWO_SIDED|95.0|0.34|0.88||p-value is adjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Cox Proportional Hazard||Age adjusted|Null hypothesis||0.88|0.34|0.012
91488474|NCT00319501|182849205|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.066
91488475|NCT00319501|182849206|SUPERIORITY_OR_OTHER|||||||0.443|||||||Fisher Exact|||||||0.443
91688173|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|3.0|12.9|||Poisson Regression|||Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.9|3.0|<0.001
91688174|NCT01339403|183268967|SUPERIORITY_OR_OTHER||Rate ratio|13.0|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Poisson Regression|||Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||23.1|7.4|<0.0001
91688175|NCT01339403|183268968|SUPERIORITY_OR_OTHER||Rate ratio|4.7|||<|0.001|TWO_SIDED|95.0|4.3|5.1|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.1|4.3|<0.001
91688176|NCT01339403|183268969|SUPERIORITY_OR_OTHER||Rate ratio|7.0|||<|0.001|TWO_SIDED|95.0|6.0|8.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||8.2|6.0|<0.001
91688177|NCT01339403|183268970|SUPERIORITY_OR_OTHER||Rate ratio|8.3|||<|0.001|TWO_SIDED|95.0|7.1|9.6|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.6|7.1|<0.001
91688178|NCT01339403|183268971|SUPERIORITY_OR_OTHER||Rate ratio|5.6|||<|0.001|TWO_SIDED|95.0|5.3|5.9|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.9|5.3|<0.001
91688179|NCT01339403|183268972|SUPERIORITY_OR_OTHER||Rate ratio|19.8|||<|0.001|TWO_SIDED|95.0|11.2|35.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||35.2|11.2|<0.001
91721076|NCT02081807|183334717|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.96|0.57|
91488476|NCT00319501|182849207|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.245
91488477|NCT00319501|182849208|SUPERIORITY_OR_OTHER||Difference in least square means|0.75||||0.086|TWO_SIDED|95.0|-0.11|1.61||p-Value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|ANOVA|ANOVA=analysis of variance.|Model included treatment and age category.|||1.61|-0.11|0.086
91688180|NCT03983980|183268973|SUPERIORITY||Risk Ratio (RR)|6.1|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91688181|NCT03983980|183268974|SUPERIORITY||Risk Ratio (RR)|6.53|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91688182|NCT03983980|183268975|SUPERIORITY||Risk Ratio (RR)|4.55|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91688183|NCT03983980|183268976|SUPERIORITY||Least squares mean difference|-4.32|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91688184|NCT03983980|183268977|SUPERIORITY||Risk Ratio (RR)|7.25|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91688185|NCT01525329|183268981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.007|||||||t-test, 2 sided|||||||< 0.007
91688186|NCT01525329|183268981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.080
91688187|NCT01525329|183268982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91688188|NCT01525329|183268982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91688189|NCT00780338|183268984|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.58
91688190|NCT00780338|183268986|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
91688191|NCT00780338|183268987|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.09
91688192|NCT00780338|183268988|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.01
91688193|NCT00780338|183268989|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
91488478|NCT00319501|182849209|SUPERIORITY_OR_OTHER||Difference in least square means|0.79||||0.045|TWO_SIDED|95.0|0.02|1.56||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|ANOVA||Model included treatment and age category.|||1.56|0.02|0.045
91688194|NCT00780338|183268990|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.45
91688195|NCT00780338|183268991|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.65
91688196|NCT00780338|183268992|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
91688197|NCT00780338|183268993|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
91688198|NCT00780338|183268994|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.02
91688199|NCT02676882|183268996|OTHER|A Chi Squared analysis was performed to determine how the rate of relapse in Group 1 (27.3%) compared to that of historical controls in the literature (67.7%). (Cohen, JAMA 2006)||||||0.005||||||A priori threshold for statistical significance: p\<0.05|Chi-squared|||||||0.005
91488479|NCT00667875|182849216|SUPERIORITY|||||||0.49||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model, Group by time (4 time blocks) with an unstructured variance/covariance matrix. Baseline drinks per day was used as a covariate.||||0.49
91488480|NCT00667875|182849217|SUPERIORITY|||||||0.03||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model (SPSS linear mixed) with an unstructured variance/covariance and baseline percent heavy drinking days as a covariate||||0.03
91488481|NCT00667875|182849218|SUPERIORITY|Anova across all three treatment groups|||||<|0.05|||||||ANOVA|Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2||||||<.05
91488482|NCT00667875|182849219|SUPERIORITY||||||<|0.05|||||||ANOVA|f 3.2 df 2||Anova across three groups||||<.05
91488483|NCT00531934|182849232|SUPERIORITY_OR_OTHER|||||||0.175|||||||Chi-squared|||||||0.175
91688200|NCT02676882|183268997|OTHER|A one-way repeated measures ANOVA was used to examine the overall course of Group 2 participants' MADRS scores. (F(6, 29)=5.16, p=0.001).||||||0.001||||||a priori threshold for statistical significance: p \<0.05|ANOVA|||||||0.001
91688201|NCT00114140|183268998|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Z-test|||Assuming exponential distribution of survival times, the null hypothesis was a 43% increase in median survival time (40.5 mo. to 57.9 mo.) and a 21% increase in 3-year survival rate (54% to 65%). Assuming 5% ineligibility, 72 patients were required to be accrued over 3 years with 3-years of follow-up resulting in 80% power and 1-sided 0.10 significance level. (N later increased to 135 to accommodate an additional separate analysis of O-6-Methylguanine-DNA Methyltransferase (MGMT) status.)||||<0.001
91688202|NCT00114140|183269000|SUPERIORITY||Hazard Ratio (HR)|3.52||||0.0006|TWO_SIDED|95.0|1.64|7.56||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Overall survival: The sample size was increased to 135 to ensure adequate power to detect a hazard ratio (HR) of 2.5 for MGMT status, at a 2-sided significance level of 0.05 with an MGMT prevalence rate of at least 30%||7.56|1.64|0.0006
91688203|NCT00114140|183269000|SUPERIORITY||Hazard Ratio (HR)|3.06||||0.0007|TWO_SIDED|95.0|1.55|6.04||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Progression-free survival||6.04|1.55|0.0007
91688204|NCT00811733|183269045|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|21.3|73.4|||||The estimated value represents the percentage of participants with OR.|||73.4|21.3|
91688205|NCT00811733|183269045|SUPERIORITY_OR_OTHER||percentage of participants|68.0|||||TWO_SIDED|95.0|45.1|86.1|||||The estimated value represents the percentage of participants with OR.|||86.1|45.1|
91527098|NCT02969525|182929506|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|3.7|||=|0.051|TWO_SIDED|95.0|1.0|13.68||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||13.68|1.00|=0.051
91527681|NCT01976364|182930492|OTHER||LS mean difference|0.53|||||TWO_SIDED|95.0|-1.58|2.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.63|-1.58|
91688206|NCT00811733|183269046|SUPERIORITY_OR_OTHER||percentage of participants|33.0|||||TWO_SIDED|95.0|11.8|61.6|||||The estimated value represents the percentage of participants with OR.|||61.6|11.8|
91688207|NCT00811733|183269046|SUPERIORITY_OR_OTHER||percentage of participants|64.0|||||TWO_SIDED|95.0|40.7|82.8|||||The estimated value represents the percentage of participants with OR.|||82.8|40.7|
91688208|NCT03885661|183269090|SUPERIORITY|||||||0.65|||||||mixed effects regression|testing for the outcome employed mixed effects regression. The key fixed effects were group assignment, period, and the group X period interaction.||||||0.65
91688209|NCT00129545|183269150|NON_INFERIORITY_OR_EQUIVALENCE|The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.|Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.42|1.07|||||Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals|||1.07|0.42|
91688210|NCT04660331|183269156|OTHER||||||||||||||||||2-sided t-test conducted for pre- and post-training results.|||
91688211|NCT04660331|183269157|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
91721077|NCT02081807|183334717|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.94|0.45|
91688212|NCT04660331|183269158|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
91688213|NCT05287230|183269207|OTHER|||||||0.061||||||A priori threshold for statistical significance is p\<0.05.|ANOVA|||||||0.061
91688214|NCT02360215|183269219|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.029|TWO_SIDED|95.0|0.59|0.96|||Gray's test|||Null hypothesis: the addition of HA-WBRT as compared to WBRT will increase time to neurocognitive failure from 53.8% in the WBRT arm to 42.8% in the HA-WBRT arm at 6 months. Treating death as a competing risk and using a Gray's test with two-sided α=0.05 to test for statistically significant difference in the distribution of neurocognitive failure times, it was calculated that 230 events over both arms would provide 90% statistical power.||0.96|0.59|0.029
91688215|NCT02360215|183269220|SUPERIORITY|||||||0.0586|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0586
91688216|NCT02360215|183269220|SUPERIORITY|||||||0.0048|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\>61 year vs. \<= 61 years) is reported here.||||0.0048
91688217|NCT02360215|183269220|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Total Recall is reported here.||||<0.0001
91688218|NCT02360215|183269221|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2656
91688219|NCT02360215|183269221|SUPERIORITY|||||||0.0067|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0067
91688220|NCT02360215|183269221|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recall is reported here.||||<0.0001
91688221|NCT02360215|183269222|SUPERIORITY|||||||0.0993|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0993
91688222|NCT02360215|183269222|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
91688223|NCT02360215|183269222|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recognition is reported here.||||<0.0001
91688224|NCT02360215|183269223|SUPERIORITY|||||||0.5988|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.5988
91688225|NCT02360215|183269223|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0005
91688226|NCT02360215|183269223|SUPERIORITY||||||<|0.0001|||||||McNemar|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part A is reported here.||||<0.0001
91721078|NCT02081807|183334718|OTHER||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.18|0.78|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.78|0.18|
91721079|NCT02081807|183334718|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.58|1.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.72|0.58|
91688227|NCT02360215|183269224|SUPERIORITY|||||||0.9226|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9226
91688228|NCT02360215|183269224|SUPERIORITY||||||<|0.0024|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0024
91688229|NCT02360215|183269224|SUPERIORITY||||||<|0.0001|||||||Regression, Cox|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part B is reported here.||||<0.0001
91688230|NCT02360215|183269225|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline COWA is reported here.||||<0.0001
91688231|NCT02360215|183269225|SUPERIORITY|||||||0.9749|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9749
91688232|NCT02360215|183269225|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here. is reported here.||||<0.0001
91688233|NCT02360215|183269226|SUPERIORITY|||||||0.2552|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2552
91688234|NCT02360215|183269226|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
91688235|NCT02360215|183269226|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline composite score is reported here.||||<0.0001
91688236|NCT02360215|183269227|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.57
91688237|NCT02360215|183269227|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Severity score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline symptom severity is reported here.||||<0.0001
91688238|NCT02360215|183269227|SUPERIORITY|||||||0.083|||||||Mixed Models Analysis|||A two-sample t-test with a 2-sided type I error of 0.05 provides \>90% statistical power to detect a medium effect size of 0.5 for a comparison of the change from baseline to 6 months from the start of treatment. The comparison at six months was tested within a mixed effects model with covariates age, RPA class, prior radiosurgery, prior surgical resection, baseline score, treatment arm, and time was used.||||0.083
91721080|NCT02081807|183334718|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.38|1.87|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.87|0.38|
91721081|NCT02081807|183334720|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.25|0.59|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.59|0.25|
91721082|NCT02081807|183334720|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.51|0.95|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.95|0.51|
91488484|NCT00531934|182849235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)||||<0.001
91488485|NCT00531934|182849241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.143|TWO_SIDED|95.0|0.525|1.109|||Log Rank|||||1.109|0.525|0.143
91488486|NCT00531934|182849244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.153|TWO_SIDED|95.0|0.529|1.116|||Log Rank|||||1.116|0.529|0.153
91488487|NCT00531934|182849250|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3||||0.003
91488488|NCT04092582|182849355|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6835|TWO_SIDED|95.0|0.55|1.47|||Regression, Cox|||||1.47|0.55|0.6835
91488489|NCT04092582|182849356|SUPERIORITY||Rate Ratio|1.0989||||0.7648|TWO_SIDED|95.0|0.5925|2.0381|||Poisson regression|||||2.0381|0.5925|0.7648
91488490|NCT04092582|182849357|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5248|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|||||1.54|0.43|0.5248
91488491|NCT04092582|182849358|SUPERIORITY|||||||0.125|||||||Mixed model for repeated measures (MMRM)|||||||0.1250
91721083|NCT02081807|183334720|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.03|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.03|0.43|
91721084|NCT02081807|183334721|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.67|
91721085|NCT02081807|183334721|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.97|
91721086|NCT02081807|183334721|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.47|0.63|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.63|0.47|
91721087|NCT02081807|183334722|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.04|0.77|
91721088|NCT02081807|183334722|OTHER||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|1.07|1.36|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.36|1.07|
91721089|NCT02081807|183334722|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.48|0.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.72|0.48|
91721090|NCT02081807|183334723|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.44|
91488492|NCT04092582|182849359|SUPERIORITY|||||||0.2249|||||||Mixed model for repeated measures (MMRM)|||||||0.2249
91488493|NCT04092582|182849360|SUPERIORITY|||||||0.9693|||||||Mixed model for repeated measures (MMRM)|||||||0.9693
91688239|NCT02360215|183269228|SUPERIORITY|||||||0.9118|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9118
91688240|NCT02360215|183269228|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline interference score is reported here.||||<0.0001
91688241|NCT02360215|183269229|SUPERIORITY|||||||0.1964|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.1964
91688242|NCT02360215|183269229|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline cognitive factor score is reported here.||||<0.0001
91721091|NCT02081807|183334723|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.98|1.57|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.57|0.98|
91721092|NCT02081807|183334723|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.14|0.54|
91488494|NCT04092582|182849361|SUPERIORITY|||||||0.9855|||||||Mixed model for repeated measures (MMRM)|||||||0.9855
91721093|NCT02081807|183334724|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.08|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.08|0.79|
91721094|NCT02081807|183334724|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|1.05|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|1.05|
91721095|NCT02081807|183334724|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.44|
91721096|NCT02081807|183334726|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.59|78.0|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||078|0.59|
91721097|NCT02081807|183334726|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.93|
91721098|NCT02081807|183334726|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.47|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.47|
91721099|NCT02081807|183334727|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.34|0.82|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.82|0.34|
91721100|NCT02081807|183334727|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.55|1.29|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.29|0.55|
91721101|NCT02081807|183334727|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.41|1.42|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.42|0.41|
91721102|NCT02081807|183334728|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.6|1.15|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.15|0.60|
91721103|NCT02081807|183334728|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.14|0.63|
91721104|NCT02081807|183334728|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.18|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.18|0.53|
91721105|NCT02081807|183334729|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.5|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.50|
91721106|NCT02081807|183334729|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.01|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group).||1.01|0.69|
91721107|NCT02081807|183334729|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.37|0.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.76|0.37|
91721108|NCT02081807|183334730|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.88|0.47|
91721109|NCT02081807|183334730|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.65|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.04|0.65|
91721110|NCT02081807|183334730|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.39|0.92|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.92|0.39|
91721111|NCT02081807|183334731|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.47|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Dabigatran vs. Warfarin (as reference group).||1.04|0.47|
91721112|NCT02081807|183334731|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.05|0.60|
91688243|NCT02360215|183269229|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Prior radiotherapy (yes vs. no) is reported here.||||0.0032
91688244|NCT02360215|183269230|SUPERIORITY|||||||0.8877|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.8877
91688245|NCT02360215|183269230|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline neurologic factor is reported here.||||<0.0001
91688246|NCT02360215|183269230|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0078
91688247|NCT02360215|183269231|SUPERIORITY|||||||0.86||||||Significance level = 0.05|t-test, 2 sided|||||||0.86
91688248|NCT02360215|183269233|SUPERIORITY|||||||0.95||||||Significance level = 0.05|t-test, 2 sided|||||||0.95
91688249|NCT02360215|183269234|SUPERIORITY|||||||0.66||||||Significance level = 0.05|t-test, 2 sided|||||||0.66
91688250|NCT02360215|183269235|SUPERIORITY|||||||0.18||||||Significance level = 0.05|t-test, 2 sided|||||||0.18
91688251|NCT02360215|183269236|SUPERIORITY|||||||0.64||||||Significance level = 0.05|t-test, 2 sided|||||||0.64
91688252|NCT02360215|183269237|SUPERIORITY|||||||0.91||||||Significance level = 0.05|t-test, 2 sided|||||||0.91
91688253|NCT02360215|183269238|OTHER|||||||0.92||||||Significance level = 0.05|t-test, 2 sided|||||||0.92
91688254|NCT02360215|183269239|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.076|TWO_SIDED|95.0|0.98|1.47||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantine|||1.47|0.98|0.076
91688255|NCT02360215|183269240|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.242|TWO_SIDED|95.0|0.91|1.43||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantin|||1.43|0.91|0.242
91688256|NCT02360215|183269241|SUPERIORITY|||||||0.47||||||Two-sided p-value = 0.05|Chi-squared|||||||0.47
91688257|NCT01050530|183269289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.0001|TWO_SIDED|95.0|-2.08|-0.93|||t-test, 2 sided|||||-0.93|-2.08|<0.0001
91688258|NCT01050530|183269290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-300.7||||0.0093|TWO_SIDED|95.0|-526.2|-75.1|||t-test, 2 sided|||||-75.1|-526.2|0.0093
91688259|NCT02414958|183269376|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||Mixed effect Model Repeated Measures||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
91688260|NCT02414958|183269376|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
91688261|NCT02414958|183269377|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.65|-0.4|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.40|-0.65|<0.0001
91688262|NCT02414958|183269377|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|97.5|-0.64|-0.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements||-0.39|-0.64|<0.0001
91527099|NCT02969525|182929507|OTHER||Odds Ratio (OR)|4.6|||=|0.002|TWO_SIDED|95.0|1.73|12.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||12.39|1.73|=0.002
91527100|NCT02969525|182929507|OTHER||Odds Ratio (OR)|11.0|||<|0.001|TWO_SIDED|95.0|3.91|30.95||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||30.95|3.91|<0.001
91688263|NCT02414958|183269378|SUPERIORITY||Adjusted Rate Ratio (%)|0.744||||0.0623|TWO_SIDED|97.75|0.518|1.069|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.069|0.518|0.0623
91688264|NCT02414958|183269378|SUPERIORITY||Adjusted Rate Ratio (%)|0.726||||0.048|TWO_SIDED|97.75|0.502|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset||1.501|0.502|0.0480
91688265|NCT02414958|183269378|SUPERIORITY||Adjusted Rate Ratio (%)|0.774||||0.0972|TWO_SIDED|95.0|0.572|1.048||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.048|0.572|0.0972
91688266|NCT02414958|183269378|SUPERIORITY||Adjusted Rate Ratio (%)|0.782||||0.118|TWO_SIDED|97.75|0.575|1.064||Negative binomial model|MMRM||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.064|0.575|0.1180
91688267|NCT02414958|183269379|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|99.75|-3.57|-1.8|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.80|-3.57|<0.0001
91688268|NCT02414958|183269379|SUPERIORITY||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|99.75|-4.15|-2.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.39|-4.15|<0.0001
91688269|NCT02414958|183269380|SUPERIORITY||Mean Difference (Final Values)|11.86|||<|0.0001|TWO_SIDED|99.75|8.78|14.93|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||14.93|8.78|<0.0001
91688270|NCT02414958|183269380|SUPERIORITY||Mean Difference (Final Values)|12.87|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|99.75|9.81|15.93|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|||15.93|9.81|<0.0001
91688271|NCT02414958|183269381|SUPERIORITY||Mean Difference (Final Values)|-16.92|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-22.04|-11.81|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-11.81|-22.04|<0.0001
91688272|NCT02414958|183269381|SUPERIORITY||Mean Difference (Final Values)|-19.04|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-24.13|-13.95|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-13.95|-24.13|<0.0001
91688273|NCT02414958|183269382|SUPERIORITY||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.121|-0.063|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.063|-0.121|<0.0001
91688274|NCT02414958|183269382|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.119|-0.062|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.062|-0.119|<0.0001
91688275|NCT02414958|183269383|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0397|TWO_SIDED|99.75|-5.2|1.0|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||1.0|-5.2|0.0397
91688276|NCT02414958|183269383|SUPERIORITY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|1.0||0.0003|TWO_SIDED|99.75|-6.8|-0.6|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.6|-6.8|0.0003
91688277|NCT02414958|183269383|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.7||0.0457|TWO_SIDED|99.75|-2.7|0.0||Nominal p-value|MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.0|-2.7|0.0457
91688278|NCT02414958|183269383|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.7||0.0006|TWO_SIDED|99.75|-4.3|-0.3|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.3|-4.3|0.0006
91688279|NCT01269918|183269384|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-5|-13|< 0.001
91688280|NCT01269918|183269384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-4|-13|< 0.001
91688281|NCT01269918|183269385|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-1.1|-2.7|< 0.001
91688282|NCT01269918|183269385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-0.9|-2.8|< 0.001
91688283|NCT01269918|183269386|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority delta = 2 mg opioid|Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-5|-10|< 0.001
91688284|NCT01269918|183269386|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-3|-10|< 0.001
91688285|NCT01269918|183269387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-10.0|3.0|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.||3|-10|< 0.001
91688286|NCT01269918|183269388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.16|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.||0.5|-2.6|0.16
91688287|NCT01269918|183269389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.6|0.03|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.||0.03|-0.6|0.07
91688288|NCT01269918|183269390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.009|TWO_SIDED|95.0|-1.0|-0.001|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.||-0.001|-1|0.009
91688289|NCT01269918|183269391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.||0.18|0.07|< 0.001
91688290|NCT01269918|183269392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.19|||Regression, Cox|||Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.||0.19|0.07|< 0.001
91688291|NCT01269918|183269393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.022|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.||0.95|0.48|0.022
91688292|NCT01269918|183269394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.81|1.62|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression||1.62|0.81|0.45
91688293|NCT01269918|183269395|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.91|TWO_SIDED|95.0|0.5|2.2|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.||2.2|0.5|0.91
91688294|NCT01269918|183269396|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.16|TWO_SIDED|95.0|0.07|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.||1.7|0.07|0.16
91688295|NCT01269918|183269397|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.||1.7|0.1|0.21
91688296|NCT04542057|183269398|SUPERIORITY||LS mean difference|0.0941|STANDARD_ERROR_OF_MEAN|0.01501|<|0.0001|TWO_SIDED|95.0|0.0647|0.1236||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1236|0.0647|<0.0001
91688297|NCT04583735|183269439|SUPERIORITY||LSMean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.396||0.0004|TWO_SIDED|95.0|-2.28|-0.69||MMRM analysis with an unstructured variance-covariance matrix including change from Baseline value as dependent variable \& covariates: Baseline value, treatment group, visit, visit-by-treatment \& visit-by-Baseline value interactions.|MMRM|||||-0.69|-2.28|0.0004
91688298|NCT00708110|183269471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.001|TWO_SIDED|95.0|-2.0|-1.07|||ANCOVA|||||-1.07|-2.00|<0.001
91688299|NCT00708110|183269471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||<|0.001|TWO_SIDED|95.0|-2.52|-1.55|||ANCOVA|||||-1.55|-2.52|<0.001
91688300|NCT00708110|183269471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-2.94|-2.02|||ANCOVA|||||-2.02|-2.94|<0.001
91688301|NCT02273388|183269573|OTHER||Difference of adjusted means|-4.56|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-10.59|1.48|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 5 minutes before infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||1.48|-10.59|
91688302|NCT02273388|183269573|OTHER||Difference of adjusted means|-7.14|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-13.18|-1.11|||||Comparison vs. 1hour infusion \[2h-1h\]|Change from baseline to 1 hour after infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-1.11|-13.18|
91688303|NCT02273388|183269573|OTHER||Difference of adjusted means|-3.58|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-9.61|2.46|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 4 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||2.46|-9.61|
91721113|NCT02081807|183334731|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.24|0.73|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.73|0.24|
91688304|NCT02273388|183269573|OTHER||Difference of adjusted means|-8.66|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-14.7|-2.63|||||Comparison vs. 1 hour \[2h-1h\]|Change from baseline to 24 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-2.63|-14.70|
91688305|NCT04331808|183269594|SUPERIORITY||Median posterior absolute risk differenc|-9.0|||||TWO_SIDED|90.0|-21.0|3.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||3.1|-21.0|
91688306|NCT04331808|183269595|SUPERIORITY||Median posterior Hazard Ratio|0.58|||||TWO_SIDED|90.0|0.33|1.0||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||1.00|0.33|
91688307|NCT04331808|183269596|SUPERIORITY||Median posterior absolute risk differenc|1.7|||||TWO_SIDED|90.0|-13.6|17.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credible Interval here Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||17.1|-13.6|
91688308|NCT04331808|183269597|SUPERIORITY||Median posterior Hazard Ratio|1.19|||||TWO_SIDED|90.0|0.71|2.04||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||2.04|0.71|
91688309|NCT04331808|183269598|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.4|3.55|||Regression, Cox|adjusted for age and sex||Day 14||3.55|0.40|
91688310|NCT04331808|183269598|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.33|2.53|||Regression, Cox|adjusted for age and centre||Day 28||2.53|0.33|
91688311|NCT04331808|183269598|SUPERIORITY||Cox Proportional Hazard|0.64|||||TWO_SIDED|95.0|0.25|1.65|||Regression, Cox|adjusted for age and centre||Day 90||1.65|0.25|
91688312|NCT04331808|183269598|SUPERIORITY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.12|1.15|||Regression, Cox|adjusted for age and centre||Day 14||1.15|0.12|
91688313|NCT04331808|183269598|SUPERIORITY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Regression, Cox|adjusted for age and centre||Day 28||1.47|0.32|
91688314|NCT04331808|183269598|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.3|1.49|||Regression, Cox|adjusted for age and centre||Day 90||1.49|0.30|
91688315|NCT04331808|183269599|SUPERIORITY||Median posterior OR|0.6|||||TWO_SIDED|95.0|0.27|1.28|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 4||1.28|0.27|
91688316|NCT04331808|183269599|SUPERIORITY||Median posterior OR|0.86|||||TWO_SIDED|95.0|0.43|1.71|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 7|% Confidence Interval is % Credible Interval here|1.71|0.43|
91688317|NCT04331808|183269599|SUPERIORITY||Median posterior OR|0.76|||||TWO_SIDED|95.0|0.4|1.42|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 14||1.42|0.40|
91688318|NCT04331808|183269599|SUPERIORITY||Median posterior OR|0.85|||||TWO_SIDED|95.0|0.39|1.82|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 4|% Confidence Interval is % Credible Interval here|1.82|0.39|
91688319|NCT04331808|183269599|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 7||1.47|0.32|
91688320|NCT04331808|183269599|SUPERIORITY||Median posterior OR|0.68|||||TWO_SIDED|95.0|0.32|1.43|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 14||1.43|0.32|
91688321|NCT04331808|183269600|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-6.9|1.7||adjusted on age and centre||||||1.7|-6.9|
91688322|NCT04331808|183269601|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.98|2.01|||Fine-Gray model|adjusted for age and centre||Day 28||2.01|0.98|
91688323|NCT04331808|183269601|SUPERIORITY||Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.82|2.52|||Fine-Gray model|||Day 28||2.52|0.82|
91688324|NCT04331808|183269601|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.8|2.03|||Fine-Gray model|adjusted on age and centre||Day 90||2.03|0.80|
91688325|NCT04331808|183269602|SUPERIORITY||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27|||Fine-Gray model|adjusted on age and centre||Day 28||2.27|1.02|
91688326|NCT04331808|183269602|SUPERIORITY||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.8|2.63|||Fine-Gray model|adjusted for age and centre||Day 28||2.63|0.80|
91688327|NCT04331808|183269602|SUPERIORITY||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.84|2.17|||Fine-Gray model|adjusted for age and centre||Day 90||2.17|0.84|
91688328|NCT04331808|183269603|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.73|1.81|||Fine-Gray model|adjusted on age and centre||Day 28||1.81|0.73|
91688329|NCT04331808|183269603|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.73|2.24|||Fine-Gray model|adjusted on age and centre||Day 90||2.24|0.73|
91688330|NCT03172494|183269631|NON_INFERIORITY|Non-inferiority of insulin degludec/liraglutide versus insulin degludec was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 0.4%. Non-inferiority was investigated on the FAS.|Mean treatment difference|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.46|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).||-0.46|-0.73|<0.0001
91688331|NCT03172494|183269631|SUPERIORITY||Mean treatment difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.49|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.||-0.49|-0.76|<0.0001
91688332|NCT00143390|183269695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.007|||||TWO_SIDED|95.0|0.771|1.317|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.317|0.771|
91688333|NCT00143390|183269696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.059|||||TWO_SIDED|95.0|0.816|1.374|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.374|0.816|
91688334|NCT00681031|183269757|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptability was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) on the Geometric Mean Fold Rise (CMFR) from pre-vaccination to 4 weeks postvaccination is \>1.4.|GMFR|3.1|||||TWO_SIDED|95.0|2.6|3.8|||||GMFR = GMT postdose divided by GMT predose|||3.8|2.6|
91688335|NCT00625872|183269758|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.43|STANDARD_ERROR_OF_MEAN|1.1||0.7232|TWO_SIDED|95.0|-3.93|3.08||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Analysis of covariance (ANCOVA) method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||3.08|-3.93|0.7232
91688336|NCT00625872|183269759|SUPERIORITY_OR_OTHER||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.51||0.1941|TWO_SIDED|95.0|-8.04|4.82||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||4.82|-8.04|0.1941
91688337|NCT00625872|183269761|SUPERIORITY_OR_OTHER|||||||0.0532||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Sequential Processing): Kruskal-Wallis Analysis of Variance (ANOVA) model was used to calculate p-value.||||0.0532
91688338|NCT00625872|183269761|SUPERIORITY_OR_OTHER|||||||0.3383||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Simultaneous Processing): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3383
91688339|NCT00625872|183269761|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Achievement): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6830
91688340|NCT00625872|183269761|SUPERIORITY_OR_OTHER|||||||0.4935||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Non-Verbal): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.4935
91688341|NCT00625872|183269761|SUPERIORITY_OR_OTHER|||||||0.3458||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Mental Processing Composite): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3458
91688342|NCT00625872|183269763|SUPERIORITY_OR_OTHER|||||||0.6256||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Distractibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6256
91688343|NCT00625872|183269763|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Alertness): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.8590
91688344|NCT00625872|183269763|SUPERIORITY_OR_OTHER|||||||1||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Flexibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||1.0000
91688345|NCT00625872|183269763|SUPERIORITY_OR_OTHER|||||||0.1234||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Go/No Go): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.1234
91688346|NCT00625872|183269763|SUPERIORITY_OR_OTHER|||||||0.3291||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Vigilance): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3291
91688347|NCT00625872|183269782|SUPERIORITY_OR_OTHER||LS Mean difference|0.14|STANDARD_ERROR_OF_MEAN|2.54||0.956|TWO_SIDED|95.0|-5.71|6.0||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||6.00|-5.71|0.9560
91688348|NCT00625872|183269798|SUPERIORITY_OR_OTHER||LS Mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.31||0.1107|TWO_SIDED|95.0|-0.15|1.25||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||1.25|-0.15|0.1107
91688349|NCT00625872|183269800|SUPERIORITY_OR_OTHER||LS Mean difference|4.67|STANDARD_ERROR_OF_MEAN|1.54||0.0161|TWO_SIDED|95.0|1.13|8.21||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||8.21|1.13|0.0161
91721114|NCT00303186|183334739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|7.03|<|0.0001|TWO_SIDED|95.0|2.4|5.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||5.10|2.40|<0.0001
91721115|NCT00303186|183334739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.72|STANDARD_DEVIATION|7.47|<|0.001|TWO_SIDED|95.0|1.65|5.78|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||5.78|1.65|<0.001
91721116|NCT00303186|183334739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|4.1||0.518|TWO_SIDED|95.0|-1.5|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.76|-1.50|0.518
91721117|NCT00303186|183334740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.72|STANDARD_DEVIATION|27.89|<|0.0001|TWO_SIDED|95.0|12.38|23.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||23.07|12.38|<0.0001
91721118|NCT00303186|183334740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|20.36|<|0.0001|TWO_SIDED|95.0|6.99|18.21|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.21|6.99|<0.0001
91721119|NCT00303186|183334740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|18.7||0.833|TWO_SIDED|95.0|-5.7|4.61|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.61|-5.70|0.833
91721120|NCT00303186|183334741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|STANDARD_DEVIATION|2.39|<|0.0001|TWO_SIDED|95.0|2.26|3.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.18|2.26|<0.0001
91721121|NCT00303186|183334741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.36|<|0.0001|TWO_SIDED|95.0|1.59|2.87|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.87|1.59|<0.0001
91721122|NCT00303186|183334741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_DEVIATION|2.03||0.309|TWO_SIDED|95.0|-0.83|0.27|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.27|-0.83|0.309
91688350|NCT00625872|183269809|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25||0.187|TWO_SIDED|95.0|-0.89|0.2||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Triceps SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.20|-0.89|0.1870
91721123|NCT00303186|183334743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|11.75||0.004|TWO_SIDED|95.0|1.619|8.301|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||8.301|1.619|0.004
91721124|NCT00303186|183334744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|18.8||0.015|TWO_SIDED|95.0|-12.155|-1.355|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-1.355|-12.155|0.015
91688351|NCT00625872|183269809|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.3494|TWO_SIDED|95.0|-0.49|0.19||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Subscapular SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.19|-0.49|0.3494
91688352|NCT00625872|183269809|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0458|TWO_SIDED|95.0|-0.54|-0.01||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Suprailiac SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||-0.01|-0.54|0.0458
91688353|NCT01512160|183269811|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.3|2.2||||||Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.||2.2|-4.3|
91721125|NCT00303186|183334745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|7.41||0.676|TWO_SIDED|95.0|-1.666|2.546|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.546|-1.666|0.676
91721126|NCT00303186|183334746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.486|STANDARD_DEVIATION|2.96|<|0.0001|TWO_SIDED|95.0|0.918|2.05|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||2.05|0.918|<0.0001
91721127|NCT00303186|183334746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|3.64|<|0.001|TWO_SIDED|95.0|1.01|2.99|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.99|1.01|<0.001
91721128|NCT00303186|183334746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|3.32||0.223|TWO_SIDED|95.0|-0.35|1.46|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.46|-0.35|0.223
91721129|NCT00303186|183334747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_DEVIATION|5.94|<|0.0001|TWO_SIDED|95.0|5.1|7.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 12: swollen joints.||7.47|5.10|<0.0001
91721130|NCT00303186|183334747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|6.35|<|0.0001|TWO_SIDED|95.0|4.48|7.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 60: swollen joints.||7.92|4.48|<0.0001
91688354|NCT01512160|183269811|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.1|2.3||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||2.3|-4.1|
91688355|NCT01512160|183269811|SUPERIORITY_OR_OTHER||LS mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|0.3|6.7||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||6.7|0.3|
91688356|NCT01512160|183269815|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.8|1.9||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||1.9|-2.8|
91688357|NCT01512160|183269815|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.7|2.0||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||2.0|-2.7|
91688358|NCT01512160|183269815|SUPERIORITY_OR_OTHER||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|0.4|5.1||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||5.1|0.4|
91688359|NCT01512160|183269815|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-12.6|10.5||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||10.5|-12.6|
91688360|NCT01512160|183269815|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|90.0|-11.5|11.4||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||11.4|-11.5|
91688361|NCT01512160|183269815|SUPERIORITY_OR_OTHER||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-4.0|19.1||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||19.1|-4.0|
91688362|NCT01512160|183269816|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-15.6|16.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||16.1|-15.6|
91688363|NCT01512160|183269816|SUPERIORITY_OR_OTHER||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|-16.5|14.8||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||14.8|-16.5|
91688364|NCT01512160|183269816|SUPERIORITY_OR_OTHER||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-6.6|25.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||25.1|-6.6|
91688365|NCT01512160|183269817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.5|
91688366|NCT01512160|183269817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|90.0|0.7|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.7|
91688367|NCT01512160|183269817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.6|2.0||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.0|0.6|
91688368|NCT01512160|183269818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.5|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.5|
91688369|NCT01512160|183269818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.4|1.8||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.8|0.4|
91688370|NCT01512160|183269818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|0.7|2.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.9|0.7|
91688371|NCT01512160|183269819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.6|
91688372|NCT01512160|183269819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.7|2.4||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|0.7|
91688373|NCT01512160|183269819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|90.0|0.4|1.3||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.3|0.4|
91688374|NCT02729909|183269837|SUPERIORITY||Median Value of confidence interval (CI)|1.0||||0.02|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||||1.9|0.1|0.020
91688375|NCT02729909|183269838|SUPERIORITY||Median Value of CI|1.0||||0.051|TWO_SIDED|95.0|0.0|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||1.9|0.0|0.051
91688376|NCT02729909|183269838|SUPERIORITY||Median Value of CI|1.5||||0.003|TWO_SIDED|95.0|1.0|2.0||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||2.0|1.0|0.003
91688377|NCT02729909|183269838|SUPERIORITY||Median Value of CI|1.0||||0.009|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||1.9|0.1|0.009
91721131|NCT00303186|183334747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.09||0.479|TWO_SIDED|95.0|-0.36|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: swollen joints and Month 60: swollen joints.||0.76|-0.36|0.479
91688378|NCT02729909|183269839|SUPERIORITY||Odds Ratio (OR)|2.08||||0.009|TWO_SIDED|95.0|1.19|3.62||The proportion of participants with an SBM within 24 hours after first dose in Week 1 is analyzed by a Cochran-Mantel-Haenszel (CMH) test stratified by center. Centers with less participants were pooled based on geographical proximity.|Cochran-Mantel-Haenszel|||||3.62|1.19|0.009
91688379|NCT02729909|183269840|SUPERIORITY||Median Value of CI|-0.4||||0.001|TWO_SIDED|95.0|-0.6|-0.2||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.2|-0.6|0.001
91688380|NCT02729909|183269840|SUPERIORITY||Median Value of CI|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||-0.1|-0.5|0.004
91688381|NCT02729909|183269840|SUPERIORITY||Median Value of CI|-0.2||||0.024|TWO_SIDED|95.0|-0.4|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.4|0.024
91688382|NCT02729909|183269840|SUPERIORITY||Median Value of CI|-0.3||||0.01|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.5|0.010
91688383|NCT02729909|183269841|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|1.0||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||1.0|0.4|<0.001
91688384|NCT02729909|183269841|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.9||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||0.9|0.4|<0.001
91688385|NCT02729909|183269841|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.8||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||0.8|0.4|<0.001
91688386|NCT02729909|183269841|SUPERIORITY||Median Value of CI|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||0.7|0.2|<0.001
91688387|NCT02729909|183269842|SUPERIORITY||Median Value of CI|-0.5||||0.02|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.1|-0.9|0.020
91688388|NCT02729909|183269842|SUPERIORITY|||||||0.072||||||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||||0.072
91688389|NCT02729909|183269842|SUPERIORITY||Median Value of CI|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.9|<0.001
91688390|NCT02729909|183269842|SUPERIORITY||Median Value of CI|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.9|0.004
91688391|NCT04779879|183269855|OTHER||Ratio of geometric least squares mean|1.04|||||TWO_SIDED|90.0|0.98|1.09|||||Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.09|0.98|
91688392|NCT04779879|183269856|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.11|0.94|
91688393|NCT04779879|183269885|OTHER||Ratio of geometric least squares mean|1.05|||||TWO_SIDED|90.0|1.0|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.11|1.00|
91688394|NCT04779879|183269886|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.07|0.97|
91688395|NCT04779879|183269887|OTHER||Ratio of geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.93|1.09|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.09|0.93|
91688396|NCT04779879|183269888|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.1|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.10|0.94|
91688397|NCT04779879|183269949|OTHER||Ratio of geometric least squares mean|0.66|||||TWO_SIDED|90.0|0.48|0.89|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.89|0.48|
91688398|NCT04779879|183269949|OTHER||Ratio of geometric least squares mean|0.58|||||TWO_SIDED|90.0|0.43|0.79|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.79|0.43|
91688399|NCT04779879|183269950|OTHER||Ratio of geometric least squares mean|1.14|||||TWO_SIDED|90.0|0.67|1.95|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.95|0.67|
91688400|NCT04779879|183269951|OTHER||Ratio of geometric least squares mean|1.06|||||TWO_SIDED|90.0|0.69|1.62|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.62|0.69|
91721132|NCT00303186|183334747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0|STANDARD_DEVIATION|11.16|<|0.0001|TWO_SIDED|95.0|6.86|11.13|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 12: tender joints.||11.13|6.86|<0.0001
91688401|NCT04779879|183269952|OTHER||Ratio of geometric least squares mean|1.11|||||TWO_SIDED|90.0|0.68|1.82|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.82|0.68|
91688402|NCT04779879|183269953|OTHER||Ratio of geometric least squares mean|1.28|||||TWO_SIDED|90.0|0.77|2.12|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||2.12|0.77|
91688403|NCT02854527|183269987|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.39|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|88.22|105.33|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R1.||105.33|88.22|
91688404|NCT02854527|183269988|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|93.17|STANDARD_DEVIATION|24.1|||TWO_SIDED|90.0|83.49|103.97|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R1.||103.97|83.49|
91688405|NCT02854527|183269989|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|102.62|STANDARD_DEVIATION|20.4|||TWO_SIDED|90.0|93.82|112.25|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R2.||112.25|93.82|
91688406|NCT02854527|183269990|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|103.96|STANDARD_DEVIATION|24.0|||TWO_SIDED|90.0|93.6|115.46|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R2.||115.46|93.60|
91688407|NCT02854527|183269991|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.49|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|93.54|101.61|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R3.||101.61|93.54|
91688408|NCT02854527|183269992|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|98.25|STANDARD_DEVIATION|14.7|||TWO_SIDED|90.0|91.85|105.09|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R3.||105.09|91.85|
91688409|NCT02854527|183269993|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|105.01|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|96.39|114.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R4.||114.40|96.39|
91688410|NCT02854527|183269994|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|104.28|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|94.95|114.53|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R4.||114.53|94.95|
91688411|NCT02854527|183269995|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.53|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|92.08|101.2|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R1.||101.20|92.08|
91688412|NCT02854527|183269996|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|97.4|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|90.87|104.41|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R2.||104.41|90.87|
91688413|NCT02854527|183269997|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.5|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|93.58|101.58|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R3.||101.58|93.58|
91688414|NCT02854527|183269998|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|107.63|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|97.04|119.39|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R4.||119.39|97.04|
91688415|NCT01959295|183269999|SUPERIORITY|||||||0.5086|||||||Mantel Haenszel|||The superiority of ASP2151 200mg to ASP2151 placebo was assessed by Mantel-Haenszel method, adjusted by disease type (labial/facial herpes and recurrent genital herpes) .||||0.5086
91688416|NCT01128179|183270009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1121||||0.3186|TWO_SIDED|95.0|-0.3389|0.1146||The a priori significance level was 5%. There was no adjustment for multiple comparisons.|ANCOVA|||Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.||0.1146|-0.3389|0.3186
91688417|NCT01128179|183270010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.54||||0.2995|TWO_SIDED|95.0|-6.15|19.23||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate. The study was not powered for the analysis of this parameter.||19.23|-6.15|0.2995
91688418|NCT01128179|183270011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.3252|TWO_SIDED|95.0|-5.36|15.57||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate. The study was not powered for the analysis of this parameter.||15.57|-5.36|0.3252
91688419|NCT01128179|183270012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1459|TWO_SIDED|95.0|-8.845|1.403||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate. The study was not powered for the analysis of this parameter.||1.403|-8.845|0.1459
91688420|NCT01128179|183270013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0297||||0.6134|TWO_SIDED|95.0|-0.1492|0.0897||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate. The study was not powered for the analysis of this parameter||0.0897|-0.1492|0.6134
91688421|NCT01128179|183270014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0294||||0.5636|TWO_SIDED|95.0|-0.0739|0.1328||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate. The study was not powered for the analysis of this parameter.||0.1328|-0.0739|0.5636
91688422|NCT01128179|183270015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0129||||0.922|TWO_SIDED|95.0|-0.2811|0.2553||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.||0.2553|-0.2811|0.9220
91688423|NCT01682811|183270016|OTHER|||||||0.0001|||||||t-test, 1 sided|||One-sample t-test comparing the absolute value to an alternate expected value of zero.||||0.0001
91688424|NCT01682811|183270019|OTHER|||||||0.24|||||||t-test, 2 sided|||Paired comparisons between treated and placebo lesions within subject.||||0.24
91688425|NCT01682811|183270022|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
91688426|NCT02694328|183270026|SUPERIORITY||Least Squares Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|0.765||0.003|TWO_SIDED|95.0|-3.88|-0.88||P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.|ANCOVA|Missing values at Week 24 were imputed using multiple imputation.||||-0.88|-3.88|0.003
91688427|NCT02694328|183270027|SUPERIORITY||Risk Difference (RD)|-13.7||||0.003|TWO_SIDED|95.0|-22.8|-4.6||P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.|Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) of ALKS 3831 vs. Olanzapine|||-4.6|-22.8|0.003
91688428|NCT02694328|183270028|SUPERIORITY||Risk Difference (RD)|-15.9||||0.001|TWO_SIDED|95.0|-25.3|-6.5|||Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) ALKS 3831 vs. Olanzapine|||-6.5|-25.3|0.001
91688429|NCT05411991|183270053|SUPERIORITY||Net treatment benefit|10.5||||0.357|TWO_SIDED|95.0|-11.9|31.9|||General pairwaise comparison|||||31.9|-11.9|0.357
91688430|NCT04653454|183270064|SUPERIORITY|||||||0.129||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.129
91688431|NCT04653454|183270064|SUPERIORITY|||||||0.008||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.008
91688432|NCT04653454|183270065|SUPERIORITY|||||||0.203||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.203
91688433|NCT04653454|183270065|SUPERIORITY||||||<|0.001||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||<0.001
91688434|NCT04653454|183270067|SUPERIORITY|||||||0.076||||||Hyperglycemic Episodes \>180 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.076
91688435|NCT04653454|183270067|SUPERIORITY|||||||0.038||||||Hyperglycemic Episodes \>250 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.038
91688436|NCT04653454|183270068|SUPERIORITY||||||<|0.0001||||||Creatinine|Spearman Correlation coefficients|||||||<0.0001
91688437|NCT04653454|183270068|SUPERIORITY|||||||0.0002||||||139GFR|Spearman Correlation coefficients|||||||0.0002
91688438|NCT04653454|183270068|SUPERIORITY|||||||0.22||||||Bicarbonate|Spearman Correlation coefficients|||||||0.22
91688439|NCT04653454|183270068|SUPERIORITY|||||||0.48||||||Hemoglobin|Spearman Correlation coefficients|||||||0.48
91688440|NCT04653454|183270068|SUPERIORITY|||||||0.77||||||MAP|Spearman Correlation coefficients|||||||0.77
91688441|NCT04653454|183270068|SUPERIORITY|||||||0.0516||||||SpO2|Spearman Correlation coefficients|||||||0.0516
91688442|NCT05525520|183270079|EQUIVALENCE|two-sided equivalence test|Least square mean difference (LSMD)|0.46|STANDARD_ERROR_OF_MEAN|0.609||0.4577|TWO_SIDED|95.0|-0.77|1.68|||MMRM|Treatment, type of cholestatic disease, week, and treatment-by-week interaction were fixed effects, and Baseline WI-NRS score was a covariate.|LSMD=EP547 minus placebo|||1.68|-0.77|0.4577
91688443|NCT05878093|183270097|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.53|-1.15|||ANCOVA||Data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-1.15|-2.53|<0.0001
91688444|NCT05878093|183270098|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.54||||0.0126|TWO_SIDED|95.0|-0.97|-0.12|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.12|-0.97|0.0126
91688445|NCT05878093|183270099|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.68||||0.0008|TWO_SIDED|95.0|-2.67|-0.69|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.69|-2.67|0.0008
91688446|NCT05878093|183270100|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.62||||0.0072|TWO_SIDED|95.0|-1.08|-0.17|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.17|-1.08|0.0072
91688447|NCT05878093|183270101|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-9.52||||0.0104|TWO_SIDED|95.0|-16.81|-2.24|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-2.24|-16.81|0.0104
91688448|NCT04479852|183270118|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.133|TWO_SIDED|95.0|-4.1|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||0.5|-4.1|0.133
91688449|NCT04479852|183270119|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.059|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.0|-0.5|0.059
91688450|NCT04479852|183270120|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.159|TWO_SIDED|95.0|-2.7|0.4|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in HAM-D score from baseline.|||0.4|-2.7|0.159
91688451|NCT04479852|183270121|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.188|TWO_SIDED|95.0|-2.5|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in SDS score from baseline.|||0.5|-2.5|0.188
91688452|NCT04479852|183270122|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.091|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in QIDS score from baseline.|||0.2|-2.0|0.091
91688453|NCT04479852|183270123|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.243|TWO_SIDED|95.0|-1.2|4.6|||Mixed Models Analysis||A positive difference favors the SP-624 treatment group, i.e., a greater increase in Q-LES-Q score from baseline.|||4.6|-1.2|0.243
91688454|NCT04479852|183270124|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.008|TWO_SIDED|95.0|-6.8|-1.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||-1.0|-6.8|.008
91688455|NCT04479852|183270125|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.8|-0.1|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||-0.1|-0.8|0.006
91721133|NCT00303186|183334747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|9.25|<|0.0001|TWO_SIDED|95.0|6.1|11.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 60: tender joints.||11.10|6.10|<0.0001
91721134|NCT00303186|183334747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|8.92||0.588|TWO_SIDED|95.0|-1.76|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: tender joints and Month 60: tender joints.||3.07|-1.76|0.588
91488495|NCT03019185|182849378|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|13.37|STANDARD_ERROR_OF_MEAN|1.4111|<|0.0001|TWO_SIDED|95.0|10.48|16.27|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||16.27|10.48|<0.0001
91688456|NCT04479852|183270126|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.134|TWO_SIDED|95.0|-0.8|6.3|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||6.3|-0.8|0.134
91688457|NCT04479852|183270127|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.437|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.6|-0.3|0.437
91688458|NCT04100018|183270131|SUPERIORITY||Cox Proportional Hazard|0.96||||0.5901|TWO_SIDED|99.0|0.77|1.19||Boundary for statistical significance p-value \< 0.01|Log Rank|Stratification factor is visceral disease (YES vs NO) as entered in the IRT.||||1.19|0.77|0.5901
91688459|NCT04100018|183270132|SUPERIORITY||Cox Proportional Hazard|1.09||||0.3572|TWO_SIDED|99.41|0.84|1.43||Boundary for statistical significance p-value \< 0.0059. Additional accuracy for p-value: 0.005866.|Log Rank||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.43|0.84|0.3572
91688460|NCT04100018|183270133|SUPERIORITY||Adjusted Difference|3.8|||||TWO_SIDED|95.0|-4.5|12.1|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||12.1|-4.5|
91688461|NCT04100018|183270136|SUPERIORITY||Percentage Difference|0.9|||||TWO_SIDED|95.0|-5.2|7.0|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||7.0|-5.2|
91688462|NCT04100018|183270137|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.86|1.16|||||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.16|0.86|
91688463|NCT03103087|183270192|SUPERIORITY||Treatment Difference|56.47|||<|0.0001|TWO_SIDED|95.0|46.45|66.49||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo.|||66.49|46.45|<0.0001
91688464|NCT03103087|183270193|SUPERIORITY||Treatment Difference|47.3|||<|0.0001|TWO_SIDED|95.0|38.04|56.56||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel|Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for the difference is based on the normal approximation.||||56.56|38.04|<0.0001
91688465|NCT03103087|183270194|SUPERIORITY||Treatment Difference|-69.2|STANDARD_ERROR_OF_MEAN|7.58|<|0.0001|TWO_SIDED|95.0|-84.1|-54.3||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. Assessed at a 2-sided α = 0.05 significance.|Mixed Models Analysis||Treatment difference was relugolix plus E2/NETA minus placebo.|||-54.3|-84.1|<0.0001
91527682|NCT01976364|182930493|OTHER||LS mean difference|-1.67|||||TWO_SIDED|95.0|-3.67|0.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.32|-3.67|
91688466|NCT03103087|183270195|SUPERIORITY||Treatment Difference|55.88|||<|0.0001|TWO_SIDED|95.0|37.25|74.52||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||74.52|37.25|<0.0001
91688467|NCT03103087|183270196|SUPERIORITY||Treatment Difference|29.99|||<|0.0001|TWO_SIDED|95.0|15.6|44.38||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||44.38|15.6|<0.0001
91688468|NCT03103087|183270197|SUPERIORITY||Treatment Difference|-10.0|STANDARD_ERROR_OF_MEAN|8.03|=|0.2153|TWO_SIDED|95.0|-25.8|5.8||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||5.8|-25.8|=0.2153
91688469|NCT03103087|183270198|SUPERIORITY||Treatment Difference|-12.2|STANDARD_ERROR_OF_MEAN|4.57|=|0.0078|TWO_SIDED|95.0|-21.3|-3.2||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||-3.2|-21.3|=0.0078
91488496|NCT03019185|182849379|SUPERIORITY||LS Mean difference (Net)|9.49|STANDARD_ERROR_OF_MEAN|1.813|<|0.0001|TWO_SIDED|97.5|5.38|13.6|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||13.60|5.38|<0.0001
91688470|NCT03103087|183270199|SUPERIORITY||Treatment Difference|-33.4|STANDARD_ERROR_OF_MEAN|3.98|<|0.0001|TWO_SIDED|95.0|-41.2|-25.5||Assessed at a 2-sided α = 0.05 significance level.|Mixed Models Analysis||Relugolix plus E2/NETA minus placebo. Treatment, visit, region, Baseline MBL and treatment by visit interaction as fixed effects.|||-25.5|-41.2|<0.0001
91688471|NCT03103087|183270202|OTHER||Risk Ratio (RR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.07|0.33|||Fisher Exact|||||0.33|0.07|<0.0001
91688472|NCT03103087|183270207|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
91688473|NCT03103087|183270208|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
91688474|NCT03103087|183270209|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
91688475|NCT03103087|183270210|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
91688476|NCT03103087|183270211|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||<0.0001
91688477|NCT03103087|183270212|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91688478|NCT03103087|183270213|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||<0.0001
91688479|NCT03103087|183270214|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
91688480|NCT03103087|183270215|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91688481|NCT03103087|183270216|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91488497|NCT03019185|182849380|SUPERIORITY||LS Mean difference (Net)|7.65|STANDARD_ERROR_OF_MEAN|2.144||0.0005|TWO_SIDED|95.0|3.41|11.89|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||11.89|3.41|0.0005
91688482|NCT03103087|183270217|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91688483|NCT03103087|183270218|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
91688484|NCT03103087|183270219|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
91688485|NCT03103087|183270220|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
91688486|NCT03103087|183270221|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91688487|NCT03103087|183270222|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91688488|NCT03103087|183270224|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
91688489|NCT03103087|183270231|SUPERIORITY|||||||0.0004||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||0.0004
91688490|NCT03283566|183270239|EQUIVALENCE|Assuming a 20-30% difference in outcome (CP/G quotient) between study arms, which is equivalent to 0.08-0.12 CP/G difference and a 0.07 standard deviation, a sample size of 6 subjects (1:1 randomization) will detect a CP/G difference of at least 0.12, assuming 80% power, with a 0.05 significance level.||||||0.739|||||||ANOVA|||||||0.739
91688491|NCT01495000|183270244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|||<|0.0001|TWO_SIDED|95.0|1.91|4.19|||ANCOVA|||||4.19|1.91|<0.0001
91688492|NCT00276484|183270274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-19.4|-13.2|||ANCOVA|Model terms: treatment and baseline LDL-C value||||-13.2|-19.4|<0.001
91688493|NCT00276484|183270275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.551||95.0|-1.1|2.1|||ANCOVA|Model terms: treatment and baseline HDL-C value||||2.1|-1.1|0.551
91688494|NCT00276484|183270276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.1|-11.6|||ANCOVA|Model terms: treatment and baseline non-HDL-C value||||-11.6|-17.1|<0.001
91688495|NCT00276484|183270277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-12.0|-7.9|||ANCOVA|Model terms: treatment and baseline Total-C value||||-7.9|-12.0|<0.001
91688496|NCT00276484|183270278|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.3|||<|0.001||95.0|-11.5|-3.1|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.|||-3.1|-11.5|<0.001
91688497|NCT00276484|183270279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-12.7|-7.6|||ANCOVA|Model terms: treatment and baseline Apo B value||||-7.6|-12.7|<0.001
91688498|NCT00276484|183270280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.313||95.0|-0.8|2.5|||ANCOVA|Model terms: treatment and baseline Apo A-I value||||2.5|-0.8|0.313
91688499|NCT00276484|183270281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-12.6|-8.2|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value||||-8.2|-12.6|<0.001
91688500|NCT00276484|183270282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-19.9|-13.1|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value||||-13.1|-19.9|<0.001
91688501|NCT00276484|183270283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-13.8|-8.2|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value||||-8.2|-13.8|<0.001
91688502|NCT00276484|183270284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.5|STANDARD_ERROR_OF_MEAN|-1.6|<|0.001||95.0|-17.7|-11.3|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value||||-11.3|-17.7|<0.001
91688503|NCT00276484|183270285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8||||0.174||95.0|-17.1|3.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.|Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.|||3.4|-17.1|0.174
91688504|NCT00276484|183270286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.37|||<|0.001||95.0|5.45|12.84|||Regression, Logistic|Model terms: treatment and baseline LDL-C value||||12.84|5.45|<0.001
91688505|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9326|||||TWO_SIDED|95.0|0.9048|0.9604||||||Time point: 0-2 hours||0.9604|0.9048|
91488498|NCT03019185|182849381|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 48.|LS Mean change from baseline|7.4|STANDARD_ERROR_OF_MEAN|1.9451||0.0008|TWO_SIDED|95.0|3.4|11.39|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.||||11.39|3.40|0.0008
91688506|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9431|||||TWO_SIDED|95.0|0.9081|0.9782||||||Time point: 2-4 hours||0.9782|0.9081|
91688507|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9503|||||TWO_SIDED|95.0|0.9419|0.9857||||||Time point: 4-9 hours||0.9857|0.9419|
91721135|NCT00303186|183334751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|11.29||0.33|TWO_SIDED|95.0|-1.3|3.82|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.82|-1.30|0.330
91688508|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9197|||||TWO_SIDED|95.0|0.8914|0.948||||||Time point: 0-2 hours||0.9480|0.8914|
91721136|NCT00303186|183334751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.56|STANDARD_DEVIATION|32.28||0.449|TWO_SIDED|95.0|-33.37|16.26|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||16.26|-33.37|0.449
91721137|NCT00303186|183334751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|38.17||0.165|TWO_SIDED|95.0|-37.04|7.04|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.04|-37.04|0.165
91721138|NCT00303186|183334752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|24.48|<|0.0001|TWO_SIDED|95.0|26.44|35.91|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||35.91|26.44|<0.0001
91721139|NCT00303186|183334752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.76|STANDARD_DEVIATION|23.24|<|0.0001|TWO_SIDED|95.0|22.42|35.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||35.10|22.42|<0.0001
91721140|NCT00303186|183334752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|24.6||0.538|TWO_SIDED|95.0|-8.7|4.6|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.60|-8.70|0.538
91721141|NCT00303186|183334753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.83|STANDARD_DEVIATION|19.6|<|0.0001|TWO_SIDED|95.0|30.04|37.63|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||37.63|30.04|<0.0001
91688509|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9349|||||TWO_SIDED|95.0|0.8986|0.9712||||||Time point: 2-4 hours||0.9712|0.8986|
91721142|NCT00303186|183334753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|STANDARD_DEVIATION|21.17|<|0.0001|TWO_SIDED|95.0|31.96|44.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||44.12|31.96|<0.0001
91721143|NCT00303186|183334753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|17.59||0.343|TWO_SIDED|95.0|-2.62|7.38|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.38|-2.62|0.343
91527683|NCT01976364|182930493|OTHER||LS mean difference|-0.61|||||TWO_SIDED|95.0|-2.86|1.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.63|-2.86|
91721144|NCT00303186|183334754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|27.56|<|0.0001|TWO_SIDED|95.0|25.88|36.49|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||36.49|25.88|<0.0001
91721145|NCT00303186|183334754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.8|STANDARD_DEVIATION|25.89|<|0.0001|TWO_SIDED|95.0|21.52|36.09|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||36.09|21.52|<0.0001
91721146|NCT00303186|183334754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|STANDARD_DEVIATION|22.77||0.301|TWO_SIDED|95.0|-9.74|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||3.07|-9.74|0.301
91721147|NCT00303186|183334755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.21|STANDARD_DEVIATION|123.2|<|0.0001|TWO_SIDED|95.0|2.01|50.4|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||50.40|2.01|<0.0001
91688510|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9498|||||TWO_SIDED|95.0|0.919|0.9805||||||Time point: 4-9 hours||0.9805|0.9190|
91688511|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9412|||||TWO_SIDED|95.0|0.9102|0.9722||||||Time point: 0-2 hours||0.9722|0.9102|
91688512|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9419|||||TWO_SIDED|95.0|0.9041|0.9796||||||Time point: 2-4 hours||0.9796|0.9041|
91688513|NCT01608100|183270291|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9449|||||TWO_SIDED|95.0|0.9046|0.9852||||||Time point: 4-9 hours||0.9852|0.9046|
91688514|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|7.0||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0004
91688515|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|2.31||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0004
91721148|NCT00303186|183334755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.19|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|7.81|18.57|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.57|7.81|<0.0001
91721149|NCT00303186|183334755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31|STANDARD_DEVIATION|14.07||0.132|TWO_SIDED|95.0|-6.4|1.77|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.77|-6.40|0.132
91721150|NCT00303186|183334756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.26|STANDARD_DEVIATION|150.1|<|0.0005|TWO_SIDED|95.0|-13.52|46.04|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||46.04|-13.52|<0.0005
91721151|NCT00303186|183334756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.81|STANDARD_DEVIATION|100.25|<|0.0001|TWO_SIDED|95.0|22.33|83.29|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||83.29|22.33|<0.0001
91721152|NCT00303186|183334756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4|STANDARD_DEVIATION|147.25||0.034|TWO_SIDED|95.0|-10.84|77.64|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||77.64|-10.84|0.034
91721153|NCT00303186|183334758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|0.66|<|0.0001|TWO_SIDED|95.0|0.35|0.62|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.62|0.35|<0.0001
91721154|NCT00303186|183334758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.56|<|0.0001|TWO_SIDED|95.0|0.26|0.56|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||0.56|0.26|<0.0001
91721155|NCT00303186|183334758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.61||0.6|TWO_SIDED|95.0|-0.24|0.14|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.14|-0.24|0.600
91721156|NCT00303186|183334759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.31|<|0.0001|TWO_SIDED|95.0|0.18|0.3|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.30|0.18|<0.0001
91721157|NCT00303186|183334759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|0.34|<|0.0001|TWO_SIDED|95.0|-0.31|-0.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-0.12|-0.31|<0.0001
91721158|NCT00303186|183334759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.27||0.789|TWO_SIDED|95.0|-0.08|0.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.06|-0.08|0.789
91721159|NCT00303186|183334760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.4|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|14.59|24.22|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||24.22|14.59|<0.0001
91721160|NCT00303186|183334760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_DEVIATION|22.08||0.0001|TWO_SIDED|95.0|-18.77|-6.59|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-6.59|-18.77|0.0001
91688516|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.0011|TWO_SIDED|95.0|1.59|5.95||Likelihood Ratio|Regression, Cox|||Hazard Ratio||5.95|1.59|0.0011
91688517|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|12.76|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
91688518|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|3.65|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
91688519|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.21|<0.0001
91688520|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|7.17|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
91688521|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|2.07|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
91721161|NCT00303186|183334760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.85|STANDARD_DEVIATION|22.22||0.115|TWO_SIDED|95.0|-1.21|10.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||10.92|-1.21|0.115
91721162|NCT00303186|183334761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED|95.0|-10.34|-4.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 12: physical component score.||-4.47|-10.34|<0.0001
91721163|NCT00303186|183334761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|STANDARD_DEVIATION|9.13|<|0.0001|TWO_SIDED|95.0|-8.56|-3.32|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 60: physical component score.||-3.32|-8.56|<0.0001
91721164|NCT00303186|183334761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_DEVIATION|8.83||0.308|TWO_SIDED|95.0|-1.19|3.68|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: physical component score and Month 60: physical component score.||3.68|-1.19|0.308
91688522|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.54||||0.0002|TWO_SIDED|95.0|1.84|6.87||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.87|1.84|0.0002
91688523|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|12.83|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
91688524|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|3.66|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
91688525|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.68|||<|0.0001|TWO_SIDED|95.0|2.25|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.25|<0.0001
91688526|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|6.07||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0020
91688527|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|2.09||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0020
91688528|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.95||||0.005|TWO_SIDED|95.0|1.41|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|1.41|0.0050
91721165|NCT00303186|183334761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|8.51||0.589|TWO_SIDED|95.0|-3.14|1.8|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 12: mental component score.||1.80|-3.14|0.589
91721166|NCT00303186|183334761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.59|STANDARD_DEVIATION|12.29||0.003|TWO_SIDED|95.0|-9.12|-2.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 60: mental component score.||-2.06|-9.12|0.003
91488499|NCT03019185|182849382|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 100.|LS Mean change from baseline|4.28|STANDARD_ERROR_OF_MEAN|1.7484||0.015|TWO_SIDED|95.0|0.84|7.72|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.||||7.72|0.84|0.0150
91488500|NCT03019185|182849383|SUPERIORITY||LS Mean difference (Net)|5.09|STANDARD_ERROR_OF_MEAN|1.656||0.0021|TWO_SIDED|97.5|1.37|8.8|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||8.80|1.37|0.0021
91688529|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|12.15|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
91688530|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Proportion Percentage|3.57|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
91688531|NCT01608100|183270292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.08|6.03||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.03|2.08|<0.0001
91688532|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|84.44|||||TWO_SIDED|95.0|75.28|91.23||||||Time point: 0-2 hours||91.23|75.28|
91488501|NCT03019185|182849384|SUPERIORITY||LS Mean difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|1.876||0.0232|TWO_SIDED|95.0|0.58|7.94|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||7.94|0.58|0.0232
91488502|NCT00333177|182849414|SUPERIORITY||||||<|0.03||||||P value is for CT-HBT X RLAI-Oral Ris interaction|ANCOVA|Covaried baseline value of dependent variable||A priori hypothesis was that CT would be superior to HBT and that RLAI would enhance this effect.||||<0.03
91688533|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.21|||||TWO_SIDED|83.81|83.81|97.09||||||Time point: 2-4 hours||97.09|83.81|
91688534|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.9|||||TWO_SIDED|95.0|86.34|97.99||||||Time point: 4-9 hours||97.99|86.34|
91688535|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|85.26|||||TWO_SIDED|95.0|76.51|91.7||||||Time point: 0-2 hours||91.70|76.51|
91688536|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|91.86|||||TWO_SIDED|95.0|83.95|96.66||||||Time point: 2-4 hours||96.66|83.95|
91688537|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|94.95|||||TWO_SIDED|95.0|88.61|98.34||||||Time point: 4-9 hours||98.34|88.61|
91688538|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|87.32|||||TWO_SIDED|95.0|77.3|94.04||||||Time point: 0-2 hours||94.04|77.30|
91688539|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.0|||||TWO_SIDED|95.0|83.4|97.01||||||Time point: 2-4 hours||97.01|83.40|
91688540|NCT01608100|183270293|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.15|||||TWO_SIDED|95.0|84.74|97.74||||||Time point: 4-9 hours||97.74|84.74|
91688541|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|85.73|||||TWO_SIDED|95.0|83.18|88.03||||||Time point: 0-2 hours||88.03|83.18|
91721167|NCT00303186|183334761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_DEVIATION|12.8||0.002|TWO_SIDED|95.0|-9.23|-2.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: mental component score and Month 60: mental component score.||-2.18|-9.23|0.002
91721168|NCT02326883|183334762|SUPERIORITY||Cox Proportional Hazard|1.07|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|95.0|0.86|1.33||A priori two-sided comparison of Care Management condition to Usual Care|Log Rank|A priori Bonferonni-corrected threshold for statistical significance was 0.025.|To clarify direction of comparison: relative hazard of suicide attempt among participants assigned to Care Management was 1.07 (95% CI 0.86 - 1.33) higher compared to participants assigned to Usual Care|Comparison of participants assigned to Care Management intervention to those assigned to continued Usual Care||1.33|0.86|0.61
91721169|NCT02326883|183334762|SUPERIORITY|A priori two-sided comparison of Skills Training to usual care.|Cox Proportional Hazard|1.29|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED|95.0|1.05|1.59||A priori Bonferonni-corrected threshold for statistical significance was 0.025.|Log Rank||To clarify direction of comparison: relative hazard of suicide attempt in participants assigned to Skills Training was 1.29 (95% CI 1.05-1.59) times higher than in those assigned to Usual Care|Comparison of Skills Training to Usual Care||1.59|1.05|0.02
91721170|NCT00284856|183334770|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.92||||||95.0|0.28|11.56|||||Estimated Value is difference in least squares mean (montelukast - placebo)|||11.56|0.28|
91721171|NCT00284856|183334770|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|10.14||||||95.0|4.5|15.78|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||15.78|4.50|
91721172|NCT00284856|183334770|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.22||||||95.0|-9.83|1.38|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||1.38|-9.83|
91721173|NCT00284856|183334771|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15||||||95.0|-0.25|-0.05|||||Estimated value is difference in least squares mean (montelukast - placebo)|||-0.05|-0.25|
91721174|NCT00284856|183334771|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2||||||95.0|-0.3|-0.1|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||-0.10|-0.30|
91688542|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|85.2|||||TWO_SIDED|95.0|82.66|87.5||||||Time point: 2-4 hours||87.50|82.66|
91721175|NCT00284856|183334771|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.05||||||95.0|-0.05|0.15|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.15|-0.05|
91721176|NCT00284856|183334772|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.09||||||95.0|-1.27|11.45|||||Estimated value is difference in least squares mean (montelukast - placebo)|||11.45|-1.27|
91721177|NCT00284856|183334772|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.21||||||95.0|4.85|17.58|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||17.58|4.85|
91721178|NCT00284856|183334772|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-6.13||||||95.0|-12.46|0.2|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.20|-12.46|
91721179|NCT00790036|183334783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.276|TWO_SIDED|95.0|0.69|1.22||P-value was obtained from the one-sided unstratified log rank test.|Log Rank|||||1.22|0.69|0.276
91527101|NCT02969525|182929507|OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.31|16.84||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||16.84|2.31|<0.001
91688543|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|82.82|||||TWO_SIDED|95.0|79.99|85.4||||||Time point: 4-9 hours||85.40|79.99|
91721180|NCT00790036|183334784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.52|1.09||There was no formal testing of the OS between treatment since the primary endpoint was not statistically significant.||||||1.09|0.52|
91721181|NCT00790036|183334785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.41|1.07||||||||1.07|0.41|
91721182|NCT02921256|183334830|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
91721183|NCT02921256|183334830|SUPERIORITY|||||||0.26|||||||Regression, Linear|||||||0.26
91721184|NCT00315341|183334888|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||shift table analyses|||categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)\& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases \>2X ULN(either ALT/AST)\& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)\>2X ULN \&remained at this level(both ALT/AST);(5)BL transaminases \>2X ULN(either ALT/AST)\& increased 2X above this level ever(either ALT/AST).||||< 0.05
91721185|NCT00090103|183334905|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.8||||0.18||95.0|0.58|1.11||Log-rank test with stratification by cluster.|Log Rank|||||1.11|0.58|0.18
91721186|NCT00090103|183334905|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.34|||<|0.001||95.0|0.26|0.45||Log-rank test with stratification by cluster.|Log Rank|||||0.45|0.26|<0.001
91688544|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|83.76|||||TWO_SIDED|95.0|81.12|86.17||||||Time point: 0-2 hours||86.17|81.12|
91688545|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|83.72|||||TWO_SIDED|95.0|81.09|86.11||||||Time point: 2-4 hours||86.11|81.09|
91688546|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|80.72|||||TWO_SIDED|95.0|77.82|83.39||||||Time point: 4-9 hours||83.39|77.82|
91688547|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|86.35|||||TWO_SIDED|95.0|83.79|88.63||||||Time point: 0-2 hours||88.63|83.79|
91688548|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|85.81|||||TWO_SIDED|95.0|83.31|88.07||||||Time point: 2-4 hours||88.07|83.31|
91688549|NCT01608100|183270294|SUPERIORITY_OR_OTHER||Percent Specificity|84.05|||||TWO_SIDED|95.0|81.31|86.54||||||Time point: 4-9 hours||86.54|81.31|
91688550|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.1|||||TWO_SIDED|95.0|96.82|98.95||||||Time point: 0-2 hours||98.95|96.82|
91688551|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.19|||||TWO_SIDED|95.0|98.25|99.7||||||Time point: 2-4 hours||99.70|98.25|
91688552|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.23|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
91688553|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.08|||||TWO_SIDED|95.0|96.81|98.95||||||Time point: 0-2 hours||98.95|96.81|
91688554|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.05|||||TWO_SIDED|95.0|98.05|99.62||||||Time point: 2-4 hours||99.62|98.05|
91721187|NCT00090103|183334907|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||0.18
91721188|NCT00090103|183334907|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||<0.001
91721189|NCT00090103|183334909|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.65|||<|0.001||95.0|0.52|0.8|||Log Rank|Log-rank test with stratification by cluster.||||0.80|0.52|<0.001
91688555|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.24|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
91721190|NCT00090103|183334909|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59|||<|0.001||95.0|0.48|0.72|||Log Rank|||||0.72|0.48|<0.001
91721191|NCT00090103|183334910|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.65
91721192|NCT00090103|183334910|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Log Rank|Mantel-Hanenszel test with stratification by cluster.||||||0.10
91721193|NCT00090103|183334911|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.95
91688556|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.73|||||TWO_SIDED|95.0|97.61|99.42||||||Time point: 0-2 hours||99.42|97.61|
91721194|NCT00090103|183334911|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.24
91721195|NCT00320086|183334938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||ANOVA||||<0.05
91721196|NCT01080261|183334950|NON_INFERIORITY_OR_EQUIVALENCE|Study had 91% statistical power to demonstrate that the 9-month rate for MACE (accounting for an expected 9-month attrition rate of 10%) is less than the performance goal, assuming a 9-month MACE rate of 8.2%.|Percent of patients experiencing a MACE|0.0|||<|0.0001|ONE_SIDED|95.0||4.9|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the percentage of patients experiencing a MACE event (primary endpoint) in the PROMUS Element cohort is less than the predefined performance goal of 24.1% (based on historical outcomes with plain balloon angioplasty \[20.2%\] plus an adjustment of 3.9% for small vessels).||4.9||<0.0001
91721197|NCT00055237|183334974|SUPERIORITY_OR_OTHER||proportion estimate,binomial exact 95%CI|31.0|STANDARD_DEVIATION|11.6|||TWO_SIDED|95.0|11.0|58.7|||sample estimate with 95% CI||As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.|||58.7|11|
91721198|NCT01134042|183334976|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.108|0.277|||ANCOVA|||||0.277|0.108|<0.001
91721199|NCT01134042|183334976|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.21|||<|0.001|TWO_SIDED|95.0|0.127|0.294|||ANCOVA|||||0.294|0.127|<0.001
91688557|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.2|||||TWO_SIDED|95.0|98.27|99.71||||||Time point: 2-4 hours||99.71|98.27|
91688558|NCT01608100|183270295|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.25|||||TWO_SIDED|95.0|98.26|99.76||||||Time point: 4-9 hours||99.76|98.26|
91688559|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|38.78|||||TWO_SIDED|95.0|31.92|45.98||||||Time point: 0-2 hours||45.98|31.92|
91688560|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.68|||||TWO_SIDED|95.0|29.03|42.76||||||Time point: 2-4 hours||42.76|29.03|
91688561|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.49|||||TWO_SIDED|95.0|29.99|43.38||||||Time point: 4-9 hours||43.38|29.99|
91688562|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.82|||||TWO_SIDED|95.0|30.43|43.56||||||Time point: 0-2 hours||43.56|30.43|
91688563|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.75|||||TWO_SIDED|95.0|29.43|42.45||||||Time point: 2-4 hours||42.45|29.43|
91688564|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|37.75|||||TWO_SIDED|95.0|31.71|44.09||||||Time point: 4-9 hours||44.09|31.71|
91688565|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.84|||||TWO_SIDED|95.0|28.7|43.47||||||Time point: 0-2 hours||43.47|28.70|
91688566|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.94|||||TWO_SIDED|95.0|29.16|43.16||||||Time point: 2-4 hours||43.16|29.16|
91688567|NCT01608100|183270296|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.05|||||TWO_SIDED|95.0|28.36|42.21||||||Time point: 4-9 hours||42.21|28.36|
91721200|NCT01134042|183334976|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the confidence interval (CI: 0.025, 1-sided significance level) for the mean difference in change from Baseline in clinic visit trough FEV1 of FF 200 µg OD versus FP 500 µg BID was greater than -125 milliliters.|Median Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.066|0.102||||||||0.102|-0.066|
91721201|NCT01134042|183334977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136||||0.048|TWO_SIDED|95.0|0.001|0.27|||ANCOVA|||||0.270|0.001|0.048
91721202|NCT01134042|183334977|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.206||||0.003|TWO_SIDED|95.0|0.073|0.339|||ANCOVA|||||0.339|0.073|0.003
91721203|NCT03345004|183334987|SUPERIORITY||Estimated ratio|1.091|||=|0.5009|TWO_SIDED|95.0|0.845|1.408|||Mixed Models Analysis|||||1.408|0.845|= 0.5009
91721204|NCT03345004|183334987|SUPERIORITY||Estimated ratio|1.557|||=|0.0078|TWO_SIDED|95.0|1.126|2.153|||Mixed Models Analysis|||||2.153|1.126|= 0.0078
91721205|NCT00984867|183335018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives, based on data from both strata combined|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.34|-0.62|<0.0001
91688568|NCT00116779|183270304|SUPERIORITY_OR_OTHER||Percentage of participants|86.0||||||95.0|73.0|94.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||94|73|
91688569|NCT00116779|183270304|SUPERIORITY_OR_OTHER||Percentage of participants|77.0||||||95.0|64.0|88.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||88|64|
91688570|NCT00116779|183270305|SUPERIORITY_OR_OTHER||Percentage of participants|90.0||||||95.0|79.0|96.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||96|79|
91688571|NCT00116779|183270305|SUPERIORITY_OR_OTHER||Percentage of participants|89.0||||||95.0|78.0|95.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||95|78|
91688572|NCT00116779|183270305|SUPERIORITY_OR_OTHER|||||||0.8413||95.0|||||Chi-squared|||||||0.8413
91688573|NCT00116779|183270306|SUPERIORITY_OR_OTHER||Percentage of participants|93.0||||||95.0|82.0|99.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||99|82|
91688574|NCT00116779|183270306|SUPERIORITY_OR_OTHER||Percentage of participants|98.0||||||95.0|87.0|100.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||100|87|
91688575|NCT00116779|183270307|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Log Rank|||Time to 50% reduction||||.904
91688576|NCT00116779|183270307|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||Log Rank|||Days to 90% reduction||||.778
91688577|NCT01690117|183270317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|3.82|11.12||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||11.12|3.82|<0.001
91688578|NCT01690117|183270318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|STANDARD_ERROR_OF_MEAN|2.21|<|0.05|TWO_SIDED|95.0|1.0|9.86||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||9.86|1.00|<0.05
91688579|NCT01690117|183270319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|STANDARD_ERROR_OF_MEAN|1.0|<|0.01|TWO_SIDED|95.0|1.01|4.97||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.97|1.01|<0.01
91688580|NCT01690117|183270320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.87||0.06|TWO_SIDED|95.0|-0.05|3.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||3.45|-0.05|0.06
91688581|NCT01690117|183270321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.22||0.3|TWO_SIDED|95.0|-0.65|2.07||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.07|-0.65|0.30
91688582|NCT01690117|183270322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|1.02||0.24|TWO_SIDED|95.0|-0.66|2.59||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.59|-0.66|0.24
91688583|NCT01690117|183270323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.04|<|0.05|TWO_SIDED|95.0|-2.5|1.62||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||1.62|-2.50|<0.05
91688584|NCT01690117|183270324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|8.86||0.88|TWO_SIDED|95.0|-2.63|2.25||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.25|-2.63|0.88
91688585|NCT01690117|183270325|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|1.92|<|0.05|TWO_SIDED|95.0|-8.74|-1.11||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-1.11|-8.74|<0.05
91688586|NCT01690117|183270326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-13.31|-3.66||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-3.66|-13.31|<0.001
91688587|NCT01690117|183270327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.98||0.05|TWO_SIDED|95.0|-7.86|0.04||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||0.04|-7.86|0.05
91688588|NCT01690117|183270328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.1||0.91|TWO_SIDED|95.0|-3.96|4.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.45|-3.96|0.91
91688589|NCT01690117|183270329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.47||0.05|TWO_SIDED|95.0|-0.01|5.81||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||5.81|-0.01|0.05
91688590|NCT01690117|183270330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.91|<|0.05|TWO_SIDED|95.0|0.68|8.33||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||8.33|0.68|<0.05
91688591|NCT01690117|183270331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53|STANDARD_ERROR_OF_MEAN|1.95|<|0.01|TWO_SIDED|95.0|-8.4|-0.65||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-0.65|-8.40|<0.01
91688592|NCT01690117|183270332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.01|TWO_SIDED|95.0|4.78|10.83||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||10.83|4.78|<0.01
91688593|NCT02321111|183270342|OTHER|ANOVA||||||0.02|||||||ANOVA|||||||0.02
91688594|NCT01400477|183270349|SUPERIORITY|||||||0.89||||||A priori vape was \<0.05|ANOVA|df 1, 37||||||0.89
91688595|NCT04620746|183270390|SUPERIORITY|||||||0.98|||||||Chi-squared, Corrected|||||||0.98
91688596|NCT04620746|183270391|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91688597|NCT02777372|183270401|OTHER|||||||0.139|||||||Regression, Linear|||Effect of group on differences in ASR t scores from follicular to luteal.||||0.139
91688598|NCT02777372|183270402|OTHER|||||||0.843||||||Effect of group on ASR t score in the first luteal phase (no medication) to the second luteal phase (sertraline).|Regression, Linear|||||||0.843
91688599|NCT02777372|183270403|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
91688600|NCT05767905|183270405|OTHER||ratio|108.49|||||TWO_SIDED|90.0|100.55|117.05|||Mixed Models Analysis|"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment and Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment.||117.05|100.55|
91688601|NCT05767905|183270405|OTHER||ratio|106.16|||||TWO_SIDED|90.0|98.39|114.54|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||114.54|98.39|
91688602|NCT05767905|183270405|OTHER||ratio|228.99|||||TWO_SIDED|90.0|178.67|293.48|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||293.48|178.67|
91688603|NCT05767905|183270405|OTHER||ratio|207.19|||||TWO_SIDED|90.0|164.41|261.09||||||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||261.09|164.41|
91688604|NCT05767905|183270405|OTHER||ratio|102.19|||||TWO_SIDED|90.0|95.55|109.3|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment||109.30|95.55|
91688605|NCT05767905|183270406|OTHER||ratio|145.49|||||TWO_SIDED|90.0|121.29|174.53|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment.||174.53|121.29|
91688606|NCT05767905|183270406|OTHER||ratio|122.64|||||TWO_SIDED|90.0|102.24|147.12|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||147.12|102.24|
91688607|NCT05767905|183270406|OTHER||ratio|284.72|||||TWO_SIDED|90.0|226.39|358.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||358.06|226.39|
91688608|NCT05767905|183270406|OTHER||ratio|327.87|||||TWO_SIDED|90.0|256.9|418.44|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||418.44|256.90|
91688609|NCT05767905|183270406|OTHER||ratio|118.63|||||TWO_SIDED|90.0|96.36|146.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment.||146.06|96.36|
91688610|NCT05807828|183270410|SUPERIORITY||Median Difference (Final Values)|7.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the cup angle of the Control Group for Cup Training and the cup angle of VR Group for Cup Training.||||<0.05
91688611|NCT05807828|183270410|SUPERIORITY||Median Difference (Final Values)|291.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the stem angle of the Control Group for Stem Training and the stem angle of VR Group for Stem Training.||||<0.05
91688612|NCT05807828|183270411|SUPERIORITY||Mean Difference (Final Values)|54.5|STANDARD_DEVIATION|106.6|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student with VR training.||||<0.05
91688613|NCT05807828|183270411|SUPERIORITY||Mean Difference (Final Values)|89.8|STANDARD_DEVIATION|133.9|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student without VR training (control).||||<0.05
91688614|NCT05807828|183270412|SUPERIORITY||Median Difference (Final Values)|14.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for cup implantation for Control cup group and the time needed for cup implantation for VR cup group||||<0.05
91688615|NCT05807828|183270412|SUPERIORITY||Median Difference (Final Values)|2.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for stem implantation for Control stem group and the time needed for stem implantation for VR stem group||||<0.05
91688616|NCT02635984|183270447|SUPERIORITY|||||||0.003|||||||Chi-squared|||Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.||||0.003
91688617|NCT02635984|183270448|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91688618|NCT02635984|183270449|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
91688619|NCT02635984|183270450|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
91688620|NCT02635984|183270451|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
91688621|NCT02635984|183270452|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
91688622|NCT02635984|183270453|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
91688623|NCT02635984|183270454|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91488503|NCT00333177|182849415|SUPERIORITY||||||<|0.02||||||P-value is for each main effect. A priori threshold for statistical significance was p\<0.05 for each main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that LAI would be superior to oral risperidone and that CT would be superior to health behavior training (HBT) based on main effects.||||<.02
91488504|NCT00333177|182849416|SUPERIORITY||Mean Difference (Final Values)|0.84||||0.001|TWO_SIDED|95.0|0.57|1.1|||t-test, 2 sided|||A priori hypothesis was that RLAI would lead to less medication non-adherence than Oral Ris.||1.10|.57|.001
91488505|NCT00333177|182849417|SUPERIORITY||||||<|0.05||||||P-value is for CT vs. HBT main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.||||<.05
91488506|NCT00333177|182849418|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
91688624|NCT03135015|183270455|OTHER||Percentage Change from Control|-14.09||||0.1146|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.1146
91688625|NCT03135015|183270455|OTHER||Percentage Change from Control|-17.42||||0.0519|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.0519
91688626|NCT03135015|183270455|OTHER||Percentage Change from Control|-8.95|||||TWO_SIDED|||||||||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||
91688627|NCT03135015|183270456|OTHER|||||||0.1146|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.1146
91688628|NCT03135015|183270456|OTHER|||||||0.0519|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.0519
91688629|NCT03135015|183270457|OTHER|||||||0.5827|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
91488507|NCT00333177|182849419|SUPERIORITY||||||<|0.02||||||A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|ANOVA|2 X 2 ANOVA was computed.||||||<0.02
91488508|NCT00333177|182849420|SUPERIORITY||||||<|0.01|||||||Chi-squared|df = 1||Chi-square of frequencies of relapse vs. non-relapse were calculated, with a priori hypothesis that RLAI would be superior to Oral Ris.||||<0.01
91527102|NCT02969525|182929507|OTHER||Odds Ratio (OR)|4.2|||=|0.004|TWO_SIDED|95.0|1.59|11.35||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.35|1.59|=0.004
91527103|NCT02969525|182929508|OTHER||Odds Ratio (OR)|2.4|||=|0.279|TWO_SIDED|95.0|0.5|11.31||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.31|0.50|=0.279
91488509|NCT00333177|182849421|SUPERIORITY||||||<|0.05||||||2 X 2 ANOVA calculated. P-value is for main effect of RLAI vs. Oral Ris.|ANOVA|||||||<.05
91488510|NCT00333177|182849422|SUPERIORITY||||||<|0.02||||||2 X 2 ANOVA computed. P-value is for main effect of CT vs. HBT.|ANOVA|||||||<.02
91488511|NCT00333177|182849423|SUPERIORITY||||||=|0.053||||||2 X 2 ANOVA computed. P-value is for RLAI vs. Oral Ris main effect.|ANOVA|||||||=.053
91488512|NCT00398918|182849425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.05||95.0|||||Mixed Models Analysis|Results presented are for post-hoc comparisons of least squares means with Tukey-Kramer adjucted p values.|The estimated value is for the difference between the means obtained for the second hour of the self-administration sessions for the placebo and zonisamide conditions.|The analysis involved a within subjects comparison. The null hypothesis was that there would be no difference in the amount of ethanol consumed in either the first or second hour of self-administration sessions. Results presented here are for the second hour of the self-administration sessions.||||<0.05
91688630|NCT03135015|183270457|OTHER|||||||0.5485|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
91721206|NCT00984867|183335019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.2466|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-1.40|-2.37|<0.0001
91688631|NCT03135015|183270458|OTHER||Percentage Change from Control|-8.53||||0.5827|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
91688632|NCT03135015|183270458|OTHER||Percentage Change from Control|9.32||||0.5485|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
91688633|NCT03135015|183270459|OTHER|||||||0.1234|||||||t-test, 2 sided|||||||0.1234
91688634|NCT03135015|183270459|OTHER|||||||0.0331|||||||t-test, 2 sided|||||||0.0331
91688635|NCT03135015|183270460|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.0500
91688636|NCT03135015|183270460|OTHER|||||||0.0568|||||||t-test, 2 sided|||||||0.0568
91688637|NCT03135015|183270461|OTHER|||||||0.0509|||||||t-test, 2 sided|||||||0.0509
91688638|NCT03135015|183270461|OTHER|||||||0.5016|||||||t-test, 2 sided|||||||0.5016
91688639|NCT03135015|183270462|OTHER|||||||0.8444|||||||t-test, 2 sided|||||||0.8444
91721207|NCT00984867|183335020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1106|<|0.0001|TWO_SIDED|95.0|-1.05|-0.62||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.62|-1.05|<0.0001
91688640|NCT03135015|183270462|OTHER|||||||0.9681|||||||t-test, 2 sided|||||||0.9681
91688641|NCT03135015|183270462|OTHER|||||||0.1022|||||||t-test, 2 sided|||||||.1022
91688642|NCT03135015|183270462|OTHER|||||||0.3738|||||||t-test, 2 sided|||||||.3738
91688643|NCT03135015|183270462|OTHER||Mean Difference (Net)|-13.123|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED||||||||Percentage Change from Control|||||
91688644|NCT03135015|183270462|OTHER||Mean Difference (Net)|-10.362|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED||||||||Percentage Change from Control|||||
91688645|NCT03135015|183270462|OTHER||Mean Difference (Net)|-13.738|STANDARD_ERROR_OF_MEAN|13.463|||TWO_SIDED||||||||Percentage Change from Control|||||
91688646|NCT03135015|183270462|OTHER||Mean Difference (Net)|-12.929|STANDARD_ERROR_OF_MEAN|14.282|||TWO_SIDED||||||||Percentage Change from Control|||||
91688647|NCT03135015|183270463|OTHER|||||||0.0111|||||||t-test, 2 sided|||||||0.0111
91688648|NCT03135015|183270463|OTHER|||||||0.1684|||||||t-test, 2 sided|||||||0.1684
91688649|NCT03135015|183270463|OTHER||Mean Difference (Net)|-11.604|STANDARD_ERROR_OF_MEAN|6.722|||TWO_SIDED||||||||Percentage Change from Control|||||
91688650|NCT03135015|183270463|OTHER||Mean Difference (Net)|12.755|STANDARD_ERROR_OF_MEAN|8.489|||TWO_SIDED||||||||Percentage Change from Control|||||
91688651|NCT03135015|183270463|OTHER||Mean Difference (Net)|-13.293|STANDARD_ERROR_OF_MEAN|9.664|||TWO_SIDED||||||||Percentage Change from Control|||||
91688652|NCT03135015|183270463|OTHER||Mean Difference (Net)|2.526|STANDARD_ERROR_OF_MEAN|5.813|||TWO_SIDED||||||||Percentage Change from Control|||||
91688653|NCT03135015|183270464|OTHER||Percentage Change from Control|-21.09||||0.0374|TWO_SIDED||||||t-test, 2 sided|||||||0.0374
91688654|NCT03135015|183270465|OTHER||Percentage Change from Control|-24.22||||0.0098|TWO_SIDED||||||t-test, 2 sided|||||||0.0098
91688655|NCT03135015|183270465|OTHER||Percentage Change from Control|-25.02||||0.0391|TWO_SIDED||||||t-test, 2 sided|||||||0.0391
91688656|NCT03135015|183270466|OTHER||Percentage Change from Control|-36.28||||0.0034|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0034
91688657|NCT03135015|183270466|OTHER||Percentage Change from Control|-33.21||||0.0058|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0058
91688658|NCT03135015|183270466|OTHER||Percentage Change from Control|-53.27||||0.0016|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0016
91688659|NCT03135015|183270466|OTHER||Percentage Change from Control|-46.19||||0.0125|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0125
91688660|NCT03135015|183270467|OTHER||Percentage Change from Control|-31.36||||0.0788|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0788
91688661|NCT03135015|183270467|OTHER||Percentage Change from Control|-30.32||||0.0887|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0887
91488513|NCT00398918|182849426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.61||95.0||||P value shown is for a post-hoc comparison of least squares means generated by the mixed model used.|Mixed Models Analysis||Analysis for difference between DSMT scores at 40 minutes post alcohol ingestion for zonisamide and placebo involved post-hoc comparisons of least squares means.|Null hypothesis: No difference in DSMT scores for zonisamide and placebo treatments 40 minutes after ingestion of ethanol.||||0.61
91688662|NCT03135015|183270467|OTHER||Percentage Change from Control|-39.96||||0.0266|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0266
91721208|NCT00984867|183335021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.92|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-34.45|-21.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-21.40|-34.45|<0.0001
91688663|NCT03135015|183270467|OTHER||Percentage Change from Control|-41.8||||0.0455|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0455
91688664|NCT03135015|183270468|OTHER||Percentage Change from Control|-41.82||||0.0261|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0261
91688665|NCT03135015|183270468|OTHER||Percentage Change from Control|-36.45||||0.0391|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0391
91688666|NCT03135015|183270468|OTHER||Percentage Change from Control|-82.11||||0.0372|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0372
91688667|NCT03135015|183270468|OTHER||Percentage Change from Control|-55.81||||0.1631|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.1631
91688668|NCT03135015|183270469|OTHER||Percentage Change from Control|-46.43||||0.0303|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0303
91688669|NCT03135015|183270469|OTHER||Percentage Change from Control|-19.64||||0.4283|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.4283
91688670|NCT01197911|183270530|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.148|||||TWO_SIDED|90.0|0.9293|1.4182||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.4182|0.9293|
91688671|NCT01197911|183270530|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5518|||||TWO_SIDED|90.0|1.2468|1.9314||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9314|1.2468|
91688672|NCT01197911|183270532|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|0.9477|||||TWO_SIDED|90.0|0.7908|1.1356||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.1356|0.7908|
91688673|NCT01197911|183270532|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0782|||||TWO_SIDED|90.0|0.8941|1.3002||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.3002|0.8941|
91688674|NCT01197911|183270546|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.2323|||||TWO_SIDED|90.0|0.9618|1.5789||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.5789|0.9618|
91688675|NCT01197911|183270546|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5587|||||TWO_SIDED|90.0|1.2165|1.9971||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9971|1.2165|
91688676|NCT01197911|183270547|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0027|||||TWO_SIDED|90.0|0.8049|1.2492||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.2492|0.8049|
91488514|NCT03917459|182849439|OTHER||LS mean of treatment difference|2.9|STANDARD_ERROR_OF_MEAN|2.94||0.3432|TWO_SIDED|95.0|-3.29|9.01|||Mixed Model Repeated Measures (MMRM)|||||9.01|-3.29|0.3432
91688677|NCT01197911|183270547|SUPERIORITY_OR_OTHER||GeometricLeast-Squares Mean Ratio|1.2254|||||TWO_SIDED|90.0|0.9836|1.5266||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.5266|0.9836|
91688678|NCT03737357|183270558|NON_INFERIORITY|The tolerance range or non-inferiority margin characterizes the largest absolute difference which is considered to be dismissible. A MBL of less than 0.5mm within the first year after implant loading constitutes an acceptable clinical standard(10, 18, 19). In this clinical trial, a non-inferiority margin of 20% of the acceptable clinical standard was chosen, which amounts to 0.1mm.|paired difference|0.01||||0.074|TWO_SIDED||||||t-test, 1 sided|Non-inferiority one-sided paired t-tests using a non-inferiority margin of -0.10mm.|The paired difference is (SLActive® bone level change from baseline (CFB) - SLA® CFB (i.e. resorption))||In the PP population, the paired difference between SLActive® and SLA® bone level change from baseline (CFB) was estimated at 0.01 mm with a standard deviation of 0.444 mm (95% CI: -Inf, 0.11; p = 0.074), based on a one-sided paired t-test with a non-inferiority margin of 0.10 mm.|||0.074
91688679|NCT01526057|183270563|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|105.67|||||TWO_SIDED|90.0|96.91|115.21|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.21|96.91|
91688680|NCT01526057|183270563|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|106.62|||||TWO_SIDED|90.0|97.65|116.41|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||116.41|97.65|
91688681|NCT01526057|183270563|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.9|||||TWO_SIDED|90.0|92.38|110.2|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||110.20|92.38|
91688682|NCT01526057|183270564|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|104.19|||||TWO_SIDED|90.0|92.75|117.06||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||117.06|92.75|
91688683|NCT01526057|183270564|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.45|||||TWO_SIDED|90.0|89.2|113.11||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.11|89.20|
91688684|NCT01526057|183270564|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|96.4|||||TWO_SIDED|90.0|85.57|108.6||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||108.60|85.57|
91688685|NCT01526057|183270565|SUPERIORITY||Test-to-reference ratio: adjusted means|103.74|||||TWO_SIDED|90.0|95.1|113.12|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.12|95.10|
91688686|NCT01526057|183270565|SUPERIORITY||Test-to-reference ratio: adjusted means|105.56|||||TWO_SIDED|90.0|96.64|115.3|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.30|96.64|
91688687|NCT01526057|183270565|SUPERIORITY||Test-to-reference ratio: adjusted means|101.76|||||TWO_SIDED|90.0|93.13|111.18|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.||111.18|93.13|
91688688|NCT01526057|183270566|SUPERIORITY||Test-to-reference ratio: adjusted means|103.36|||||TWO_SIDED|90.0|92.81|115.12||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.12|92.81|
91488515|NCT00491764|182849463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9||||0.005||95.0|8.9|36.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||36.8|8.9|0.005
91688689|NCT01526057|183270566|SUPERIORITY||Test-to-reference ratio: adjusted means|101.33|||||TWO_SIDED|90.0|90.82|113.04||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.04|90.82|
91688690|NCT01526057|183270566|SUPERIORITY||Test-to-reference ratio: adjusted means|98.03|||||TWO_SIDED|90.0|87.83|109.4||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||109.40|87.83|
91688691|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.31|1.78|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.78|0.31|
91688692|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.6|1.88|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.88|0.60|
91688693|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.66|1.73|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.73|0.66|
91688694|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.73|1.56|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.56|0.73|
91688695|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.62|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.62|0.68|
91688696|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.66|1.69|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.69|0.66|
91688697|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.7|2.0|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||2.00|0.70|
91688698|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.28|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||1.73|0.28|
91688699|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.43|1.54|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.54|0.43|
91721209|NCT00984867|183335022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|1.4659||0.5583||95.0|-3.75|2.03||Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||2.03|-3.75|0.5583
91721210|NCT00984867|183335023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-21.73|-7.9||Not significant. Hierarchical testing procedure stopped at previous endpoint|ANCOVA|with treatment group and stratum as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-7.90|-21.73|
91688700|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.49|1.42|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.42|0.49|
91688701|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.22|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.22|0.50|
91688702|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.44|0.57|
91688703|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.88|2.1|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.10|0.88|
91688704|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.78|2.18|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||2.18|0.78|
91688705|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.36|2.45|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||2.45|0.36|
91688706|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||1.44|0.41|
91688707|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.47|1.31|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.31|0.47|
91688708|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.48|1.13|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.13|0.48|
91688709|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.55|1.36|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.36|0.55|
91688710|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||1.95|0.85|
91688711|NCT01526057|183270585|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.73|0.70|
91688712|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.12|1.79|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.79|0.12|
91688713|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.2|1.26|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.26|0.20|
91688714|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.43|1.41|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.41|0.43|
91688715|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.61|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.74|0.61|
91688716|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.56|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.74|0.56|
91688717|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.34|1.36|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.36|0.34|
91688718|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.46|1.63|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||1.63|0.46|
91688719|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.27|2.6|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||2.60|0.27|
91688720|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.31|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.62|0.31|
91688721|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.41|1.4|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.40|0.41|
91527104|NCT02969525|182929508|OTHER||Odds Ratio (OR)|4.1|||=|0.065|TWO_SIDED|95.0|0.92|17.88||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||17.88|0.92|=0.065
91688722|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.57|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.57|0.51|
91688723|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.51|1.68|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.68|0.51|
91688724|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.68|2.19|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.19|0.68|
91721211|NCT00984867|183335024|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|41.2|||TWO_SIDED|95.0|11.1|26.4||Not significant. Hierarchical testing procedure stopped at previous endpoint|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0.||26.4|11.1|
91688725|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.44|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||1.62|0.44|
91688726|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.44|7.2|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||7.20|0.44|
91527684|NCT01976364|182930493|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.27|2.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.09|-2.27|
91688727|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.52|3.86|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||3.86|0.52|
91688728|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.51|1.87|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.87|0.51|
91688729|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.5|1.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.50|0.50|
91688730|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.69|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.69|0.52|
91688731|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|0.93|3.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||3.50|0.93|
91688732|NCT01526057|183270586|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.51|1.89|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.89|0.51|
91688733|NCT03649347|183270624|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.720|ANOVA|Main effect of time: p\<.001, np2=.798; main effect of group: p\<.001, np2=.711||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=4.76.||||<.001
91688734|NCT03649347|183270625|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.542|ANOVA|Main effect of time: p\<.001, np2=.598; and main effect of group: p\<.001, np2=.439||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 96%, critical F=4.76.||||<.001
91688735|NCT03649347|183270627|SUPERIORITY||||||<|0.005||||||Interaction effect: p\<.005, np2=.481|ANOVA|Main effect of time: p\<.001, np2=.572; and main effect of group p\<.001, np2=.626||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=3.49.||||<.005
91688736|NCT03493685|183270638|OTHER||Slope difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7491|TWO_SIDED|95.0|-1.74|2.41|||Mixed Models Analysis|||||2.41|-1.74|0.7491
91688737|NCT03493685|183270639|OTHER||Risk Difference (RD)|16.0||||0.0094|TWO_SIDED|95.0|3.96|28.04|||Mixed Models Analysis|||||28.04|3.96|0.0094
91688738|NCT03493685|183270640|OTHER||Slope difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4203|TWO_SIDED|95.0|-1.27|3.04|||Mixed Models Analysis|||||3.04|-1.27|0.4203
91688739|NCT03493685|183270641|OTHER||Mean Difference (Final Values)|1.8||||0.2708|TWO_SIDED|95.0|-1.39|4.93|||ANCOVA|||||4.93|-1.39|0.2708
91688740|NCT02218463|183270644|SUPERIORITY|||||||0.206|||||||Fisher Exact|||Assessment of complete resolution between the 2 study arms.||||0.206
91688741|NCT02218463|183270645|SUPERIORITY|||||||0.0001|||||||ANOVA|||Time Effect||||0.0001
91688742|NCT02218463|183270645|SUPERIORITY|||||||0.37|||||||ANOVA|||Treatment Effect||||0.370
91688743|NCT02218463|183270645|SUPERIORITY|||||||0.425|||||||ANOVA|||Treatment by time interaction||||0.425
91688744|NCT03511105|183270716|OTHER||Absolute Difference|-30.46|STANDARD_ERROR_OF_MEAN|48.662|||TWO_SIDED|95.0|-127.07|65.51|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI has been presented.|||65.51|-127.07|
91688745|NCT03511105|183270716|OTHER||Percentage change|8.73|STANDARD_ERROR_OF_MEAN|13.453|||TWO_SIDED|95.0|-21.41|31.3|||||Percentage change on GSK2798745 relative to placebo has been presented.|||31.30|-21.41|
91688746|NCT03511105|183270717|OTHER||Absolute Difference|-4.26|STANDARD_ERROR_OF_MEAN|13.679|||TWO_SIDED|95.0|-31.49|22.87|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||22.87|-31.49|
91688747|NCT03511105|183270717|OTHER||Percentage change|7.31|STANDARD_ERROR_OF_MEAN|22.837|||TWO_SIDED|95.0|-48.2|41.64|||||Percentage change on GSK2798745 relative to placebo has been presented.|||41.64|-48.20|
91688748|NCT03511105|183270718|OTHER||Absolute Difference|-0.06|STANDARD_ERROR_OF_MEAN|3.178|||TWO_SIDED|95.0|-6.28|6.2|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||6.20|-6.28|
91688749|NCT03511105|183270718|OTHER||Percentage change|0.1|STANDARD_ERROR_OF_MEAN|5.429|||TWO_SIDED|95.0|-11.15|10.16|||||Percentage change on GSK2798745 relative to placebo has been presented.|||10.16|-11.15|
91688750|NCT02810457|183270742|EQUIVALENCE|A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.|Ratio in ORR|0.96|||||TWO_SIDED|90.0|0.86|1.08||||||||1.08|0.86|
91688751|NCT02810457|183270743|OTHER|Ratio in ORR analysis of FKB238 versus Avastin.|Ratio in ORR|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||Comparison between groups: Risk ratio in ORR at Week 19 by BICR.||1.06|0.83|
91688752|NCT02810457|183270744|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.82|1.16|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.16|0.82|
91688753|NCT02810457|183270745|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.96|1.45|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.45|0.96|
91688754|NCT02810457|183270746|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.23|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.23|0.74|
91688755|NCT02810457|183270747|OTHER|Comparison between arms: Odds ratio.|Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.58|||||Odds ratio \>1 favors FKB238.|The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).||1.58|0.64|
91688756|NCT02750618|183270782|SUPERIORITY||Least Squares Mean Difference|0.96|||<|0.0001|TWO_SIDED|95.0|0.73|1.19|||GEE model|||||1.19|0.73|< 0.0001
91688757|NCT02750618|183270784|SUPERIORITY||Difference in LS Means|2.21|||<|0.0001|TWO_SIDED|95.0|2.07|2.35|||GEE model|||||2.35|2.07|< 0.0001
91688758|NCT02750618|183270785|SUPERIORITY||Difference in LS Means|2.23|||<|0.0001|TWO_SIDED|95.0|2.01|2.45|||GEE model|||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The least squares (LS) mean, standard error (SE), 95% confidence interval (CI) and 2-sided p-value are from the GEE model.||2.45|2.01|< 0.0001
91688759|NCT02750618|183270786|SUPERIORITY||Difference in LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.53|||GEE model|||||-1.53|-1.98|< 0.0001
91688760|NCT02750618|183270787|SUPERIORITY||Difference in LS Means|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.8||The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|GEE model|||||-1.80|-2.25|< 0.0001
91688761|NCT02750618|183270788|SUPERIORITY||Difference in LS Means|1.21|||<|0.0001|TWO_SIDED|95.0|0.9|1.51|||GEE model|||||1.51|0.90|< 0.0001
91688762|NCT02750618|183270789|SUPERIORITY||Difference in LS Means|1.51|||<|0.0001|TWO_SIDED|95.0|1.27|1.76||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|GEE|||||1.76|1.27|< 0.0001
91488516|NCT00491764|182849463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.1|||<|0.001||95.0|38.0|70.1|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.1|38.0|<0.001
91688763|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-82.91||||0.0004|TWO_SIDED|95.0|-128.68|-37.15|||GEE model|||Week 4||-37.15|-128.68|0.0004
91688764|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-83.84||||0.064|TWO_SIDED|95.0|-172.55|4.88|||GEE model|||Week 12||4.88|-172.55|0.0640
91688765|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-161.38|||<|0.0001|TWO_SIDED|95.0|-186.7|-136.05|||GEE model|||Week 20||-136.05|-186.70|< 0.0001
91688766|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-214.99|||<|0.0001|TWO_SIDED|95.0|-241.7|-188.28|||GEE model|||Week 40||-188.28|-241.70|< 0.0001
91688767|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-226.58|||<|0.0001|TWO_SIDED|95.0|-249.11|-204.06|||GEE model|||Week 48||-204.06|-249.11|< 0.0001
91688768|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-216.45|||<|0.0001|TWO_SIDED|95.0|-248.13|-184.77|||GEE model|||Week 56||-184.77|-248.13|< 0.0001
91688769|NCT02750618|183270793|SUPERIORITY||Difference in LS Means|-216.76|||<|0.0001|TWO_SIDED|95.0|-241.66|-191.86|||GEE model|||Week 64||-191.86|-241.66|< 0.0001
91688770|NCT02750618|183270793|SUPERIORITY||LS Mean|-231.22|||<|0.0001|TWO_SIDED|95.0|-262.51|-199.93|||GEE|||Week 76||-199.93|-262.51|< 0.0001
91688771|NCT02750618|183270793|SUPERIORITY||LS Mean|-237.78|||<|0.0001|TWO_SIDED|95.0|-262.94|-212.62|||GEE|||Week 88||-212.62|-262.94|< 0.0001
91688772|NCT02750618|183270793|SUPERIORITY||LS Mean|-218.14|||<|0.0001|TWO_SIDED|95.0|-248.21|-188.08|||GEE|||Week 100||-188.08|-248.21|< 0.0001
91688773|NCT02750618|183270793|SUPERIORITY||LS Mean|-233.91|||<|0.0001|TWO_SIDED|95.0|-255.66|-212.16|||GEE|||Week 112||-212.16|-255.66|< 0.0001
91688774|NCT02750618|183270793|SUPERIORITY||LS Mean|-252.22|||<|0.0001|TWO_SIDED|95.0|-268.51|-235.93|||GEE|||Week 124||-235.93|-268.51|< 0.0001
91688775|NCT02750618|183270793|SUPERIORITY||LS Mean|-267.89|||<|0.0001|TWO_SIDED|95.0|-293.61|-242.16|||GEE|||Week 136||-242.16|-293.61|< 0.0001
91688776|NCT02750618|183270793|SUPERIORITY||LS Mean|-248.05|||<|0.0001|TWO_SIDED|95.0|-272.85|-223.25|||GEE|||Week 148||-223.25|-272.85|< 0.0001
91688777|NCT02750618|183270793|SUPERIORITY||LS Mean|-248.47|||<|0.0001|TWO_SIDED|95.0|-270.01|-226.93|||GEE|||Week 160||-226.93|-270.01|< 0.0001
91688778|NCT04055740|183270801|SUPERIORITY|||||||0.2201|||||||Spearman Correlation Coefficient|This test measures correlation of avg ILA grade per patient with total time of lead extraction. Average ILA grade of all patients in outcome measures.||H0: rho = 0 Spearman correlation coefficient calculated between average ILA grade and total time of lead extraction||||0.2201
91688779|NCT04055740|183270801|SUPERIORITY|||||||0.5157|||||||Spearman Correlation Coefficient|This measures correlation of avg ILA grade per patient with total laser pulsations used for extraction. Avg ILA grade of patients in outcome measures.||H0: rho = 0 Spearman Correlation coefficient calculated between average ILA grades and laser pulsations||||0.5157
91688780|NCT01518322|183270832|SUPERIORITY_OR_OTHER||Kappa Statistics|0.049|||||TWO_SIDED|95.0|-0.0895|0.1875||||||Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.||0.1875|-0.0895|
91688781|NCT00707239|183270836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|70.0|-21.6|10.9||||||Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||10.9|-21.6|
91688782|NCT00707239|183270836|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.0|||||TWO_SIDED|70.0|-6.1|24.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||24.8|-6.1|
91688783|NCT00707239|183270837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2|||||TWO_SIDED|70.0|-14.3|14.0||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||14.0|-14.3|
91688784|NCT00707239|183270837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5|||||TWO_SIDED|70.0|4.3|31.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||31.8|4.3|
91688785|NCT00707239|183270840|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-18.5|||||TWO_SIDED|70.0|-39.6|4.2||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||4.2|-39.6|
91688786|NCT00707239|183270840|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|70.0|-23.8|20.9||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||20.9|-23.8|
91688787|NCT00707239|183270841|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Nausea: p-value was calculated using 2-tail Fischer's exact test.||||0.527
91688788|NCT00707239|183270841|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Vomiting: p-value was calculated using 2-tail Fischer's exact test.||||0.390
91688789|NCT00707239|183270842|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
91688790|NCT00707239|183270843|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
91688791|NCT00707239|183270849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0479||||0.78|TWO_SIDED|95.0|0.754|1.46|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced nausea and did not experience nausea.||1.46|0.754|0.78
91688792|NCT00707239|183270849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84644||||0.356|TWO_SIDED|95.0|0.593|1.21|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced vomiting and did not experience vomiting.||1.21|0.593|0.356
91688793|NCT00707239|183270850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0054||||0.836|TWO_SIDED|95.0|0.956|1.06|||Regression, Logistic|||Statistical analysis was carried out between categories, cure and failure/indeterminate.||1.06|0.956|0.836
91488517|NCT00491764|182849463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.5|||<|0.001||95.0|28.5|62.4|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||62.4|28.5|<0.001
91488518|NCT00491764|182849463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.012||95.0|6.7|33.3|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||33.3|6.7|0.012
91688794|NCT00707239|183270854|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Intravenous antibiotic treatment: One-way analysis of variance (ANOVA) with treatment as factor was used to calculate p-value.||||0.245
91688795|NCT00707239|183270854|SUPERIORITY_OR_OTHER|||||||0.484|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Hospital stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.484
91688796|NCT00707239|183270854|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||ICU stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.192
91688797|NCT00776035|183270881|SUPERIORITY||||||<|0.005|||||||Student's t-test|||Average myocardial blood flow, men versus women||||<0.005
91688798|NCT00776035|183270882|SUPERIORITY||||||<|0.05|||||||Student's t-test|||Average myocardial fatty acid utilization, men versus women||||<0.05
91688799|NCT03442751|183270883|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0004|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Repeated measures mixed analysis of covariance model||-0.4|-1.5|0.0004
91688800|NCT03442751|183270884|SUPERIORITY|last observation carried forward was used to impute missing Month 12 data|Mean Difference (Net)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|||repeated measures mixed analysis of covariance model||-0.6|-1.6|<0.0001
91688801|NCT01870778|183270896|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3857|TWO_SIDED|95.0|0.83|1.15||Adjusted alpha p-value based on multiple testing procedure.|Log Rank|One-sided p-value||||1.15|0.83|0.3857
91688802|NCT01870778|183270897|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0968|TWO_SIDED|95.0|0.75|1.07||Adjusted p-value based on multiple testing procedure|Gehan's generalized Wilcoxon test|One-sided p-value||||1.07|0.75|0.0968
91688803|NCT01870778|183270898|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.81|1.08|||Log Rank|2-sided p-value||||1.08|0.81|0.3890
91688804|NCT01870778|183270899|SUPERIORITY|||||||0.2204||||||Based on multiple testing procedure|Wilcoxon rank sum test|One-sided p-value||||||0.2204
91688805|NCT01870778|183270900|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.2744|TWO_SIDED|95.0|0.88|1.07||Adjusted p-value based on multiple testing procedure|Log Rank|||||1.07|0.88|0.2744
91688806|NCT01870778|183270901|SUPERIORITY|||||||0.2103|||||||Wilcoxon rank sum test|2-sided p-value||||||0.2103
91688807|NCT01870778|183270902|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.005|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Exertional dyspnea||1.14|1.02|0.0050
91688808|NCT01870778|183270902|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0051|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Orthopnea||1.14|1.02|0.0051
91688809|NCT01870778|183270902|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9962|TWO_SIDED|95.0|0.95|1.05|||Log Rank|2-sided p-value||Rales||1.05|0.95|0.9962
91688810|NCT01870778|183270902|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0196|TWO_SIDED|95.0|1.01|1.15|||Log Rank|2-sided p-value||Jugular venous pressure||1.15|1.01|0.0196
91688811|NCT01870778|183270902|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.2158|TWO_SIDED|95.0|0.98|1.1|||Log Rank|2-sided p-value||Peripheral edema, pre-sacral edema||1.10|0.98|0.2158
91688812|NCT01870778|183270903|SUPERIORITY||Ratio of RLX030 to placebo|0.9401||||0.0209|TWO_SIDED|95.0|0.8921|0.9907|||Repeated measures model|||Day 2||0.9907|0.8921|0.0209
91688813|NCT01870778|183270903|SUPERIORITY||Ratio of RLX030 to placebo|0.898||||0.0034|TWO_SIDED|95.0|0.8358|0.9649|||Repeated measures model|||Day 5||0.9649|0.8358|0.0034
91688814|NCT01870778|183270903|SUPERIORITY||Ratio of RLX030 to placebo|0.9074||||0.0209|TWO_SIDED|95.0|0.8355|0.9854|||Repeated measures model|||Day 14||0.9854|0.8355|0.0209
91488519|NCT00491764|182849463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.1|||<|0.001||95.0|21.1|53.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||53.2|21.1|<0.001
91688815|NCT01870778|183270904|SUPERIORITY||Ratio of RLX030 to placebo|0.8597||||0.0007|TWO_SIDED|95.0|0.7876|0.9385|||Repeated measures model|||Day 2||0.9385|0.7876|0.0007
91688816|NCT01870778|183270904|SUPERIORITY||Ratio of RLX030 to placebo|0.9539||||0.3709|TWO_SIDED|95.0|0.86|1.0579|||Repeated measures model|||Day 5||1.0579|0.8600|0.3709
91688817|NCT01870778|183270904|SUPERIORITY||Ratio of RLX030 to placebo|0.9543||||0.3893|TWO_SIDED|95.0|0.8578|1.0617|||Repeated measures model|||Day 14||1.0617|0.8578|0.3893
91688818|NCT01870778|183270905|SUPERIORITY||Ratio of RLX030 to placebo|0.9637||||0.0003|TWO_SIDED|95.0|0.9447|0.983|||Repeated measures model|||Day 2||0.9830|0.9447|0.0003
91688819|NCT01870778|183270905|SUPERIORITY||Ratio of RLX030 to placebo|0.9922||||0.5361|TWO_SIDED|95.0|0.9677|1.0172|||Repeated measures model|||Day 5||1.0172|0.9677|0.5361
91688820|NCT01870778|183270905|SUPERIORITY||Ratio of RLX030 to placebo|0.9863||||0.375|TWO_SIDED|95.0|0.9567|1.0169|||Repeated measures model|||Day 14||1.0169|0.9567|0.3750
91688821|NCT01805089|183270906|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91688822|NCT01875978|183270913|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-value \<0.05 is significance meaningful.|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis: phytosterols improve metabolic status||||<0.05
91688823|NCT01875978|183270914|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Hypothesis: phytosterols increase the anti-oxidative capacity.||||<0.05
91688824|NCT01875978|183270915|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Phytosterols increase IGF-1||||<0.05
91688825|NCT01875978|183270916|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis:phytosterols increase endothelial progenitor cells to provide endothelial repair and vessel protection||||<0.05
91688826|NCT04870710|183270920|SUPERIORITY||Median Difference (Net)|0.1||||0.1|TWO_SIDED||||||Friedman||||Non-parametric tests were used consisting of Friedman and Durbin Conover tests|||0.10
91688827|NCT01866098|183270937|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.83
91688828|NCT01866098|183270938|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
91688829|NCT01866098|183270939|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.19
91688830|NCT01866098|183270940|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.96
91688831|NCT01866098|183270941|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.92
91688832|NCT01866098|183270942|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.98
91688833|NCT01866098|183270943|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.95
91688834|NCT01866098|183270944|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.43
91688835|NCT01184079|183270972|NON_INFERIORITY_OR_EQUIVALENCE|"Sample size: (1 + 1/u)(Zα + Zβ)2 σ2 /\[log (RGMT) -δ0\] u= ratio of the size of the Standard schedule to Alternate schedule groups (u =1, for equal size groups); one-sided alpha (0.025)/4 for multiplicity of serotypes. Average log-transformed and geometric mean titers (GMTs) with a two-sided 95% confidence interval of the ratio of the GMTs were used.~Non-inferiority is determined if upper bound GMT ratio of standard group to alternate group \< 1.5."|largest upper bound GMT ratio|0.82|||||||||||||Non-inferiority is determined if upper bound GMT ratio of standard 6 month group to alternate 12 month group \< 1.5.|The primary endpoint would demonstrate noninferiority if the upper bound of the 95% two-sided confidence interval (CI) of the ratio of GMT for Standard schedule group divided by that of Alternate schedule group is \<1.5.||||
91688836|NCT01184079|183270974|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Chi-squared|||null hypothsesis: no difference in proportion of side effects reported between groups||||0.26
91688837|NCT03417687|183270975|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-14.7%, +14.7%).|Mean Difference (Net)|1.4|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-0.75|3.6||||||The primary efficacy analysis tested the mean difference in the predicted percentage of remaining pulmonary function as measured by 129Xe MRI relative to the value as measured by 133Xe scintigraphy (reference standard) if a pre-defined section of lung were resected.||3.60|-0.75|
91688838|NCT03417687|183270977|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|3.71|STANDARD_DEVIATION|4.39|||TWO_SIDED|95.0|2.12|5.29||||||||5.29|2.12|
91688839|NCT03417687|183270978|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-0.476|1.26||||||||1.26|-0.476|
91688840|NCT03417687|183270979|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|1.35|STANDARD_DEVIATION|3.22|||TWO_SIDED|95.0|0.184|2.505||||||||2.505|0.184|
91688841|NCT03417687|183270980|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-0.96|STANDARD_DEVIATION|3.16|||TWO_SIDED|95.0|-2.101|0.181||||||||0.181|-2.101|
91688842|NCT03417687|183270981|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-2.721|STANDARD_DEVIATION|3.82|||TWO_SIDED|95.0|-4.096|-1.345||||||||-1.345|-4.096|
91688843|NCT03417687|183270982|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|3.96|||TWO_SIDED|95.0|-3.192|-0.335||||||||-0.335|-3.192|
91688844|NCT00619060|183270997|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||Binomial|||||||0.01
91688845|NCT01808573|183270998|SUPERIORITY||Hazard Ratio (HR)|0.762||||0.0059|TWO_SIDED|95.0|0.626|0.926|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||0.926|0.626|0.0059
91688846|NCT01808573|183270999|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.2086|TWO_SIDED|95.0|0.723|1.073|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||1.073|0.723|0.2086
91688847|NCT01808573|183271000|SUPERIORITY|||||||0.043|||||||Gray's test|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.||||||0.043
91688848|NCT01808573|183271001|SUPERIORITY|||||||0.1201|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.1201
91688849|NCT01808573|183271002|SUPERIORITY|||||||0.0328|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.0328
91688850|NCT01808573|183271003|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.0004|TWO_SIDED|95.0|0.332|0.736|||Log Rank||Lapatinib Plus Capecitabine is the reference.|||0.736|0.332|0.0004
91688851|NCT02487225|183271005|SUPERIORITY|||||||0.5796|||||||Kruskal-Wallis|||Admission (baseline)||||0.5796
91688852|NCT02487225|183271005|SUPERIORITY|||||||0.8415|||||||Kruskal-Wallis|||Day 5||||0.8415
91721212|NCT00671060|183335025|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.682|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Rates of success were compared across study arms. The study was a separate, non-comparative efficacy study. In order to have 80% power (alpha=.05) to demonstrate that each misoprostol regimen was 95%, ± 5%, effective, we enrolled 73 women in each arm of the study, or 146 women total. The sample size also provided 80% power (alpha=.05) to detect a significant difference between treatments should 200μg prove 98% effective and 100μg prove 88% effective.||||<0.05
91721213|NCT00267670|183335089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.46|||||||ANOVA|||Sample size estimates were based on 30% reduction in ALT in the treatment group \& 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), \& a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, \& accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.||||0.46
91721214|NCT00267670|183335090|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.||||0.16
91721215|NCT00267670|183335091|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
91688853|NCT02487225|183271006|SUPERIORITY|||||||0.1109|||||||Kruskal-Wallis|||Admission (baseline)||||0.1109
91688854|NCT02487225|183271006|SUPERIORITY|||||||0.4619|||||||Kruskal-Wallis|||||||0.4619
91688855|NCT02487225|183271007|SUPERIORITY|||||||0.1236|||||||Kruskal-Wallis|||Admission (baseline)||||0.1236
91688856|NCT02487225|183271007|SUPERIORITY|||||||0.9468|||||||Kruskal-Wallis|||Day 5||||0.9468
91688857|NCT02487225|183271008|SUPERIORITY|||||||0.157|||||||Kruskal-Wallis|||Admission (baseline)||||0.157
91688858|NCT02487225|183271008|SUPERIORITY|||||||0.3173|||||||Kruskal-Wallis|||Day 5||||0.3173
91688859|NCT00489255|183271018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.17|1.11|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test for treatment was stratified by site.||The null hypothesis was no difference between treatments.||1.11|0.17|0.09
91721216|NCT00267670|183335092|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
91721217|NCT02107898|183335105|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.1|||<|0.0001|TWO_SIDED|95.0|-68.5|-59.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.8|-68.5|<0.0001
91721218|NCT02107898|183335106|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.3|||<|0.0001|TWO_SIDED|95.0|-69.4|-61.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.3|-69.4|<0.0001
91721219|NCT02107898|183335107|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.5|||<|0.0001|TWO_SIDED|95.0|-65.3|-57.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.7|-65.3|<0.0001
91721220|NCT02107898|183335108|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.1|||<|0.0001|TWO_SIDED|95.0|-65.8|-58.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.3|-65.8|<0.0001
91527105|NCT02969525|182929508|OTHER||Odds Ratio (OR)|7.5|||=|0.006|TWO_SIDED|95.0|1.77|31.28||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||31.28|1.77|=0.006
91688860|NCT00489255|183271019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.025|TWO_SIDED|95.0|0.21|0.9|||Cochran-Mantel-Haenszel|||||0.90|0.21|0.025
91688861|NCT00489255|183271020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.09|0.7|||Cochran-Mantel-Haenszel|||||0.70|0.09|0.005
91688862|NCT00489255|183271021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.23|2.48|||Cochran-Mantel-Haenszel|||||2.48|0.23|0.65
91688863|NCT00489255|183271022|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.21||||0.32|TWO_SIDED|95.0|-0.64|0.21|||ANOVA|Treatment effect in ANOVA was adjusted for site.||||0.21|-0.64|0.32
91688864|NCT00489255|183271023|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07||||0.001|TWO_SIDED|95.0|-1.71|-0.43|||ANOVA|||||-0.43|-1.71|0.001
91688865|NCT00489255|183271024|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01||||0.95|TWO_SIDED|95.0|-0.2|0.19|||ANOVA|||||0.19|-0.20|0.95
91688866|NCT00489255|183271025|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.88
91688867|NCT00489255|183271026|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.019
91688868|NCT00489255|183271027|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|||||||0.29
91688869|NCT00489255|183271028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.17|TWO_SIDED|95.0|0.5|1.1||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.1|0.5|0.17
91688870|NCT00489255|183271029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.008|TWO_SIDED|95.0|0.1|0.7||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||0.7|0.1|0.008
91688871|NCT00489255|183271030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.49|TWO_SIDED|95.0|0.6|1.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.3|0.6|0.49
91688872|NCT00489255|183271031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|0.4
91688873|NCT00489255|183271032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.62||95.0|0.6|2.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||2.3|0.6|0.62
91688874|NCT00489255|183271033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.96|TWO_SIDED|95.0|-3.59|3.76|||ANOVA|ANCOVA model with baseline score (score at Visit 1/Screening) as a covariate, and site and treatment as factors.||||3.76|-3.59|0.96
91688875|NCT00489255|183271034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.93|TWO_SIDED|95.0|-4.37|4.02|||ANOVA|||||4.02|-4.37|0.93
91688876|NCT00489255|183271035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.84|TWO_SIDED|95.0|-4.12|3.34|||ANOVA|||||3.34|-4.12|0.84
91688877|NCT00489255|183271036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.97||||0.25|TWO_SIDED|95.0|-2.17|8.11|||ANOVA|||||8.11|-2.17|0.25
91688878|NCT00489255|183271037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.47||||0.46|TWO_SIDED|95.0|-2.47|5.4|||ANOVA|||||5.40|-2.47|0.46
91688879|NCT00489255|183271038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96||||0.33|TWO_SIDED|95.0|-3.13|9.06|||ANOVA|||||9.06|-3.13|0.33
91688880|NCT00489255|183271039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.93|TWO_SIDED|95.0|-5.57|6.11|||ANOVA|||||6.11|-5.57|0.93
91688881|NCT03953612|183271040|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
91688882|NCT03953612|183271041|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
91688883|NCT03953612|183271042|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear mixed effects||||||0.7
91688884|NCT03953612|183271043|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
91688885|NCT03953612|183271044|SUPERIORITY|||||||0.042|||||||. Negative binomial regression models|||||||0.042
91688886|NCT03953612|183271045|SUPERIORITY|||||||0.125|||||||. Negative binomial regression models|||||||0.125
91688887|NCT02028676|183271065|NON_INFERIORITY_OR_EQUIVALENCE|Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details|Hazard Ratio (HR)|1.13||||0.59|TWO_SIDED|95.0|0.73|1.73|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.73|0.73|0.59
91688888|NCT02028676|183271065|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions detailed above, \>90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).|Risk Difference (RD)|0.32||||0.43|TWO_SIDED|95.0|-0.47|1.12|||Comparison of poisson rates|Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference|Difference is CDM minus LCM|"Assumptions:~* control group (LCM) event rate 3% per year~* rates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%~* recruitment is over 1.5 years and follow-up for a minimum further 3.5 years.~* cumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough."||1.12|-0.47|0.43
91688889|NCT02028676|183271066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.83|TWO_SIDED|95.0|0.83|1.16|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.16|0.83|0.83
91688890|NCT02028676|183271067|SUPERIORITY_OR_OTHER|||||||0.33|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).||||0.33
91688891|NCT02028676|183271068|SUPERIORITY_OR_OTHER|||||||0.69|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.69
91688892|NCT02028676|183271069|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.0001
91688893|NCT02028676|183271069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.01|TWO_SIDED|95.0|1.07|1.63|||Regression, Cox||HR is Arm B vs A|||1.63|1.07|0.01
91688894|NCT02028676|183271069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.29|1.94|||Regression, Cox|||||1.94|1.29|<0.001
91688895|NCT02028676|183271070|NON_INFERIORITY_OR_EQUIVALENCE|631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).|Risk Difference (RD)|-1.6||||0.65|TWO_SIDED|95.0|-8.4|5.2|||Chi-squared||Difference in suppression \<80 copies/ml in once-daily minus twice-daily|||5.2|-8.4|0.65
91688896|NCT02028676|183271072|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Hazard Ratio (HR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.37|||Log Rank||Hazard ratio is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough"||2.37|1.14|0.007
91721221|NCT02107898|183335109|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.3|||<|0.0001|TWO_SIDED|95.0|-57.5|-49.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.1|-57.5|<0.0001
91688897|NCT02028676|183271072|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Risk Difference (RD)|4.0||||0.006|TWO_SIDED|95.0|0.8|7.2|||Poisson regression for risk difference||Risk difference is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough."||7.2|0.8|0.006
91688898|NCT02028676|183271073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.33|TWO_SIDED|95.0|0.83|1.72|||Log Rank||Hazard ratio is stop vs continue.|||1.72|0.83|0.33
91721222|NCT02107898|183335110|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|||<|0.0001|TWO_SIDED|95.0|-57.8|-49.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-57.8|<0.0001
91688899|NCT02028676|183271074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.45|TWO_SIDED|95.0|0.49|1.44|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.44|0.49|0.45
91688900|NCT02028676|183271074|SUPERIORITY_OR_OTHER|||||||0.43|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.43
91721223|NCT02107898|183335111|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.5|||<|0.0001|TWO_SIDED|95.0|-61.5|-53.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.5|-61.5|<0.0001
91721224|NCT02107898|183335112|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-62.3|-54.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.8|-62.3|<0.0001
91688901|NCT02028676|183271074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.23|TWO_SIDED|95.0|0.33|1.31|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.31|0.33|0.23
91688902|NCT02028676|183271074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.93|TWO_SIDED|95.0|0.52|1.81|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.81|0.52|0.93
91688903|NCT02028676|183271075|SUPERIORITY_OR_OTHER|||||||0.89|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.89
91688904|NCT02028676|183271075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.48|0.53|0.64
91688905|NCT02028676|183271075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.52|0.54|0.71
91688906|NCT02028676|183271076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.73|1.38|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.38|0.73|0.98
91688907|NCT02028676|183271076|SUPERIORITY_OR_OTHER|||||||0.44|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.44
91688908|NCT02028676|183271076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.3|TWO_SIDED|95.0|0.55|1.2|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.20|0.55|0.30
91688909|NCT02028676|183271076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.24|TWO_SIDED|95.0|0.54|1.17|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.17|0.54|0.24
91688910|NCT02028676|183271077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.52|TWO_SIDED|95.0|0.82|1.49|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM.|||1.49|0.82|0.52
91721225|NCT02107898|183335113|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.5|||<|0.0001|TWO_SIDED|95.0|-44.6|-38.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.4|-44.6|<0.0001
91721226|NCT02107898|183335114|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-54.9|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-54.9|<0.0001
91721227|NCT02107898|183335115|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.5|||<|0.0001|TWO_SIDED|95.0|-57.9|-51.1|||Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.1|-57.9|<0.0001
91488520|NCT00491764|182849464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.7||||0.002||95.0|11.2|40.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||40.2|11.2|0.002
91688911|NCT02028676|183271077|SUPERIORITY_OR_OTHER|||||||0.34||||||Global test with 2df, adjusted for randomization stratification factors|Log Rank|||||||0.34
91488521|NCT00491764|182849464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
91488522|NCT00491764|182849464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|48.5|||<|0.001||95.0|31.4|65.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||65.5|31.4|<0.001
91488523|NCT00491764|182849464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
91488524|NCT00491764|182849464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.3|||<|0.001||95.0|37.8|70.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.8|37.8|<0.001
91721228|NCT02107898|183335116|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-41.7|-36.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.4|-41.7|<0.0001
91527106|NCT02969525|182929508|OTHER||Odds Ratio (OR)|2.9|||=|0.172|TWO_SIDED|95.0|0.63|13.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||13.39|0.63|=0.172
91688912|NCT02028676|183271077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.19|TWO_SIDED|95.0|0.54|1.13|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.13|0.54|0.19
91688913|NCT02028676|183271077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.25|TWO_SIDED|95.0|0.56|1.16|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.16|0.56|0.25
91688914|NCT02028676|183271078|SUPERIORITY_OR_OTHER|||||||0.71|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.71
91688915|NCT02028676|183271078|SUPERIORITY_OR_OTHER|||||||0.58|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.58
91688916|NCT02028676|183271079|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
91688917|NCT02028676|183271079|SUPERIORITY_OR_OTHER|||||||0.9|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.90
91688918|NCT02028676|183271080|SUPERIORITY_OR_OTHER|||||||0.64|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.64
91688919|NCT02028676|183271080|SUPERIORITY_OR_OTHER|||||||0.3|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.30
91688920|NCT02028676|183271081|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.45
91688921|NCT02028676|183271082|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.70
91688922|NCT02028676|183271083|SUPERIORITY_OR_OTHER|||||||0.59||0.0|||||Regression, Linear|Adjusted for randomization stratification factors||||||0.59
91688923|NCT02028676|183271083|SUPERIORITY_OR_OTHER|||||||0.01|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.01
91688924|NCT02028676|183271084|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.81
91688925|NCT02028676|183271084|SUPERIORITY_OR_OTHER|||||||0.03|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.03
91688926|NCT02028676|183271085|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
91688927|NCT02028676|183271085|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
91688928|NCT02028676|183271086|SUPERIORITY_OR_OTHER|||||||0.2|||||||Chi-squared|||||||0.20
91527107|NCT02172625|182929534|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|26.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
91688929|NCT02028676|183271086|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
91688930|NCT02028676|183271087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.22|TWO_SIDED|95.0|0.48|1.29|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.29|0.48|0.22
91688931|NCT02028676|183271088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.09|TWO_SIDED|95.0|0.42|1.075|||Log Rank||Hazard ratio is CDM vs LCM|||1.075|0.420|0.09
91688932|NCT02028676|183271088|SUPERIORITY_OR_OTHER|||||||0.04|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.04
91688933|NCT02028676|183271088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.017|TWO_SIDED|95.0|1.15|4.08|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||4.08|1.15|0.017
91688934|NCT02028676|183271088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.034|TWO_SIDED|95.0|1.05|3.8|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||3.80|1.05|0.034
91688935|NCT02028676|183271089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.04|TWO_SIDED|95.0|1.02|1.66|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.66|1.02|0.04
91688936|NCT02028676|183271089|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.53
91688937|NCT02028676|183271089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.68|1.25|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.25|0.68|0.60
91688938|NCT02028676|183271089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.56|TWO_SIDED|95.0|0.81|1.46|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.46|0.81|0.56
91688939|NCT02028676|183271090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.84|TWO_SIDED|95.0|0.58|1.56|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.56|0.58|0.84
91688940|NCT02028676|183271090|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.002
91688941|NCT02028676|183271090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|1.74|8.29|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||8.29|1.74|0.001
91688942|NCT02028676|183271090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.006|TWO_SIDED|95.0|1.39|6.85|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||6.85|1.39|0.006
91688943|NCT02028676|183271091|SUPERIORITY_OR_OTHER|||||||0.53|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.53
91688944|NCT02028676|183271091|SUPERIORITY_OR_OTHER|||||||0.46|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.46
91688945|NCT02028676|183271092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.3||||0.52|TWO_SIDED|95.0|-9.3|4.7|||Chi-squared|||||4.7|-9.3|0.52
91688946|NCT02028676|183271093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.39|TWO_SIDED|95.0|-1.2|0.5|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.5|-1.2|0.39
91688947|NCT02028676|183271094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.9|0.9|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.9|-0.9|0.98
91721229|NCT02107898|183335117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|552.1|||<|0.0001|TWO_SIDED|95.0|105.6|2886.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2886.8|105.6|<0.0001
91721230|NCT02107898|183335118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1367.8|||<|0.0001|TWO_SIDED|95.0|137.8|13578.3||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13578.3|137.8|<0.0001
91688948|NCT02028676|183271095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.2|-1.9|0.12
91688949|NCT02028676|183271096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.82|TWO_SIDED|95.0|-60.0|76.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||76|-60|0.82
91688950|NCT02028676|183271097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.0||||0.36|TWO_SIDED|95.0|-104.0|38.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||38|-104|0.36
91688951|NCT02028676|183271098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.0||||0.2|TWO_SIDED|95.0|-220.0|46.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||46|-220|0.20
91721231|NCT02107898|183335119|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-36.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.0|-48.0|<0.0001
91721232|NCT02107898|183335120|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-30.9|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.1|-30.9|<0.0001
91688952|NCT02028676|183271100|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.2|TWO_SIDED|95.0|0.11|1.64|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.64|0.11|0.20
91688953|NCT02028676|183271101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.77|0.31|0.51
91688954|NCT02028676|183271102|SUPERIORITY_OR_OTHER|||||||0.16|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.16
91721233|NCT02107898|183335121|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.002|TWO_SIDED|95.0|2.1|9.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.4|2.1|0.0020
91688955|NCT02028676|183271103|SUPERIORITY_OR_OTHER|||||||0.54|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.54
91688956|NCT02028676|183271104|SUPERIORITY_OR_OTHER|||||||0.08|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.08
91688957|NCT02028676|183271105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.82|TWO_SIDED|95.0|0.72|1.52|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.52|0.72|0.82
91688958|NCT02028676|183271106|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.31|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.27|0.48|0.31
91688959|NCT02028676|183271107|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
91688960|NCT02028676|183271108|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
91721234|NCT02107898|183335122|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.0382|TWO_SIDED|95.0|0.2|7.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|0.2|0.0382
91721235|NCT02107898|183335123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.4|||<|0.0001|TWO_SIDED|95.0|-47.0|-35.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.7|-47.0|<0.0001
91688961|NCT02028676|183271109|SUPERIORITY_OR_OTHER|||||||0.93|||||||Generalized estimating equations|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.93
91688962|NCT02028676|183271110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.5|3.25|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.25|1.50|<0.001
91688963|NCT02028676|183271111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.44|TWO_SIDED|95.0|0.56|3.85|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.85|0.56|0.44
91688964|NCT02028676|183271112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.4||||0.03|TWO_SIDED|95.0|1.05|5.48|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||5.48|1.05|0.03
91688965|NCT02028676|183271113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.98||||0.18|TWO_SIDED|95.0|0.44|35.7|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||35.7|0.44|0.18
91688966|NCT02028676|183271114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.34|TWO_SIDED|95.0|0.53|6.17|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||6.17|0.53|0.34
91688967|NCT02028676|183271115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.68|TWO_SIDED|95.0|0.12|4.15|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||4.15|0.12|0.68
91688968|NCT02028676|183271116|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
91688969|NCT02028676|183271117|SUPERIORITY_OR_OTHER|||||||0.19|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.19
91688970|NCT02028676|183271118|SUPERIORITY_OR_OTHER|||||||0.34|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.34
91688971|NCT02028676|183271119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.13|TWO_SIDED|95.0|-1.4|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||0.2|-1.4|0.13
91688972|NCT02028676|183271120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.68|TWO_SIDED|95.0|-65.0|42.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||42|-65|0.68
91688973|NCT02028676|183271121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.04|TWO_SIDED|95.0|1.02|2.5|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||2.50|1.02|0.04
91721236|NCT02107898|183335124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.5||||0.0007|TWO_SIDED|95.0|-24.4|-6.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.6|-24.4|0.0007
91688974|NCT02028676|183271122|SUPERIORITY_OR_OTHER|||||||0.21||||||Adjusted for randomization stratification factors|Generalised estimating equation|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.21
91688975|NCT00852202|183271123|SUPERIORITY|||||||0.7408|||||||ANCOVA|||||||0.7408
91688976|NCT00852202|183271123|SUPERIORITY|||||||0.9961|||||||ANCOVA|||||||0.9961
91688977|NCT00852202|183271124|SUPERIORITY|||||||0.3441|||||||ANCOVA|||||||0.3441
91688978|NCT00852202|183271124|SUPERIORITY|||||||0.2683|||||||ANCOVA|||||||0.2683
91688979|NCT01263938|183271217|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
91688980|NCT01263938|183271217|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
91688981|NCT01263938|183271217|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
91721237|NCT02107898|183335125|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|3.7|9.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.3|3.7|<0.0001
91721238|NCT02107898|183335126|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|||<|0.0001|TWO_SIDED|95.0|3.6|9.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.0|3.6|<0.0001
91488525|NCT00491764|182849465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
91488526|NCT00491764|182849465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
91488527|NCT00491764|182849465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||<|0.001||95.0|50.6|82.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||82.8|50.6|<0.001
91488528|NCT00491764|182849465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
91488529|NCT00491764|182849465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.1|||<|0.001||95.0|40.7|73.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||73.5|40.7|<0.001
91688982|NCT01263938|183271218|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
91688983|NCT01263938|183271219|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
91688984|NCT01263938|183271220|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
91688985|NCT03051672|183271265|SUPERIORITY|||||||||||||The study terminated at stage 1 and no p-value was estimated.||||The study uses a Simon 2-stage design. In stage 1, if \>/=1 of 8 achieved OR then continue to stage 2 (enroll 19 more). If \>/= 3 of 27 respond, the regimen would be considered promising. The null ORR\<= 3% and alternative ORR\>/=20%. With this design, the probability of stopping the trial early is 58% if the true ORR is 3%. This design at 80% power to declare the combination effective, while controlling for less than 5% 1-sided type I error under the null hypothesis.|The study terminated at stage 1 and no p-value was estimated.|||
91688986|NCT01328184|183271272|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|102.82|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|97.58|108.35|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||108.35|97.58|
91688987|NCT01328184|183271273|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|101.94|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|98.54|105.47|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||105.47|98.54|
91688988|NCT01328184|183271274|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|99.22|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|93.4|105.39|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV).|No formal testing, investigation of relative bioavailability.||105.39|93.40|
91688989|NCT01328184|183271275|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|105.81|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|99.47|112.55|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||112.55|99.47|
91688990|NCT04179838|183271302|SUPERIORITY|||||||0.001||||||Corrected for multiple comparisons in piriform cortex|t-test, 1 sided|||Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.||||0.001
91688991|NCT04179838|183271303|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.021
91688992|NCT04179838|183271304|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.63
91688993|NCT04179838|183271305|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.08
91688994|NCT04179838|183271306|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.28
91688995|NCT04179838|183271307|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.50
91688996|NCT04179838|183271308|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.58
91688997|NCT02763046|183271309|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3512|TWO_SIDED|95.0|0.74|2.36|||Regression, Logistic|||||2.36|0.74|0.3512
91488530|NCT01601132|182849469|SUPERIORITY_OR_OTHER|||||||0.5663||||||Significant difference defined a priori as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.5663
91489406|NCT02484690|182851583|SUPERIORITY||Difference in Least Squares Means|0.35||||0.7086|TWO_SIDED|80.0|-0.86|1.57||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.57|-0.86|0.7086
91688998|NCT02763046|183271310|SUPERIORITY||Odds Ratio (OR)|1.33||||0.401|TWO_SIDED|95.0|0.68|2.6|||Regression, Logistic|||Week 12||2.60|0.68|0.4010
91688999|NCT02763046|183271310|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4382|TWO_SIDED|95.0|0.67|2.55|||Regression, Logistic|||Week 12||2.55|0.67|0.4382
91721239|NCT02469857|183335148|SUPERIORITY|||||||0.135|||||||Chi-squared|||This analysis utilized the mITT analysis population.||||0.135
91689000|NCT02763046|183271310|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0934|TWO_SIDED|95.0|0.91|3.5|||Regression, Logistic|||Week 16||3.50|0.91|0.0934
91689001|NCT02763046|183271310|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2619|TWO_SIDED|95.0|0.75|2.9|||Regression, Logistic|||Week 16||2.90|0.75|0.2619
91689002|NCT02763046|183271311|SUPERIORITY||LS (least square) Mean|-10.29|STANDARD_ERROR_OF_MEAN|6.25||0.0997|TWO_SIDED|95.0|-22.55|1.96|||Mixed Model for Repeated Measures (MMRM)|||||1.96|-22.55|0.0997
91689003|NCT02763046|183271311|SUPERIORITY||LS Mean|-12.3|STANDARD_ERROR_OF_MEAN|7.23||0.0888|TWO_SIDED|95.0|-26.47|1.87|||Mixed Model for Repeated Measures (MMRM)|||||1.87|-26.47|0.0888
91689004|NCT02763046|183271311|SUPERIORITY||LS Mean|-8.29|STANDARD_ERROR_OF_MEAN|7.18||0.2484|TWO_SIDED|95.0|-22.36|5.79|||Mixed Model for Repeated Measures (MMRM)|||||5.79|-22.36|0.2484
91689005|NCT02763046|183271312|SUPERIORITY||LS Mean|-2.06||||0.7735|TWO_SIDED|95.0|-16.11|11.98|||Mixed Model for Repeated Measures (MMRM)|||delayed tapering (W12) vs early tapering (W16)||11.98|-16.11|0.7735
91689006|NCT02763046|183271313|SUPERIORITY||LS Mean|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1926|TWO_SIDED|95.0|-0.99|0.2|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.20|-0.99|0.1926
91689007|NCT02763046|183271313|SUPERIORITY||LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.35||0.1914|TWO_SIDED|95.0|-1.14|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.23|-1.14|0.1914
91689008|NCT02763046|183271313|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3397|TWO_SIDED|95.0|-1.01|0.35|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.35|-1.01|0.3397
91689009|NCT02763046|183271313|SUPERIORITY||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.0384|TWO_SIDED|95.0|-1.33|-0.04|||Mixed Model for Repeated Measures (MMRM)|||Week 16||-0.04|-1.33|0.0384
91689010|NCT02763046|183271313|SUPERIORITY||LS Mean|-0.41|STANDARD_ERROR_OF_MEAN|0.33||0.2116|TWO_SIDED|95.0|-1.05|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 16||0.23|-1.05|0.2116
91689011|NCT02763046|183271314|SUPERIORITY||LS Mean|0.63|STANDARD_ERROR_OF_MEAN|1.02||0.5384|TWO_SIDED|95.0|-1.38|2.63|||Mixed Model for Repeated Measures (MMRM)|||||2.63|-1.38|0.5384
91721240|NCT02469857|183335148|SUPERIORITY|||||||0.025|||||||Chi-squared|||This analysis utilized the US-mITT analysis population.||||0.025
91689012|NCT02763046|183271314|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|1.18||0.9251|TWO_SIDED|95.0|-2.43|2.21|||Mixed Model for Repeated Measures (MMRM)|||||2.21|-2.43|0.9251
91689013|NCT02763046|183271314|SUPERIORITY||LS Mean|1.36|STANDARD_ERROR_OF_MEAN|1.16||0.2432|TWO_SIDED|95.0|-0.93|3.66|||Mixed Model for Repeated Measures (MMRM)|||||3.66|-0.93|0.2432
91689014|NCT00080912|183271315|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.|Risk Difference (RD)|4.0||||0.03|ONE_SIDED|95.0||9.2||p-value is for one-sided non-inferiority test|Cochran-Mantel-Haenszel||The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary|||9.2||0.03
91689015|NCT00818766|183271319|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.3||||0.26||95.0|-11.3|2.7|||Fisher Exact|||||2.7|-11.3|.26
91689016|NCT00818766|183271320|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.93||||0.77|TWO_SIDED|95.0|-6.1|4.3|||Fisher Exact|||||4.3|-6.1|0.77
91689017|NCT00818766|183271321|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.21|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|.21
91689018|NCT00818766|183271322|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
91689019|NCT00818766|183271324|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
91689020|NCT00818766|183271325|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
91689021|NCT01111318|183271398|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.15|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|98.89|153.36|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||153.36|98.89|
91689022|NCT01111318|183271398|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|146.97|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|118.02|183.02|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||183.02|118.02|
91689023|NCT01111318|183271398|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|174.7|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|140.29|217.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||217.55|140.29|
91689024|NCT01111318|183271399|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|103.81|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|82.29|130.95|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||130.95|82.29|
91721241|NCT02469857|183335152|SUPERIORITY|||||||0.069|||||||Chi-squared|||||||0.069
91721242|NCT02469857|183335153|SUPERIORITY|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
91721243|NCT02469857|183335154|SUPERIORITY|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||||||0.195
91721244|NCT02469857|183335155|SUPERIORITY|||||||0.596|||||||Wilcoxon (Mann-Whitney)|||||||0.596
91721245|NCT02469857|183335156|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
91721246|NCT02469857|183335157|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
91721247|NCT02469857|183335158|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.554|TWO_SIDED|95.0|0.5|1.46|||Log Rank|||||1.46|0.50|0.554
91527108|NCT02172625|182929535|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|15.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
91721248|NCT02469857|183335159|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.148|TWO_SIDED|95.0|0.23|1.26|||Log Rank|||||1.26|0.23|0.148
91721249|NCT02469857|183335160|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.736|TWO_SIDED|95.0|0.46|1.73|||Log Rank|||||1.73|0.46|0.736
91721250|NCT02469857|183335161|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.093|TWO_SIDED|95.0|0.09|1.25|||Log Rank|||||1.25|0.09|0.093
91689025|NCT01111318|183271399|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.31|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|97.74|155.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||155.55|97.74|
91689026|NCT01111318|183271399|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|148.41|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|117.65|187.23|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||187.23|117.65|
91689027|NCT00725491|183271432|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Whitehead|||||||<0.001
91689028|NCT01998919|183271440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-10.3|17.0|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||17.0|-10.3|
91689029|NCT01998919|183271441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|||||TWO_SIDED|95.0|-5.6|26.8|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||26.8|-5.6|
91689030|NCT01998919|183271442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48|||||TWO_SIDED|95.0|-2.7|27.7|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||27.7|-2.7|
91689031|NCT01998919|183271443|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Log Rank|||||||0.0075
91689032|NCT01998919|183271443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.0099|TWO_SIDED|95.0|0.22|0.81|||Wald test|||||0.81|0.22|0.0099
91689033|NCT01998919|183271444|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
91689034|NCT01998919|183271444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48||||0.0001|TWO_SIDED|95.0|0.33|0.7|||Wald Test|||||0.70|0.33|0.0001
91689035|NCT01998919|183271445|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
91721251|NCT02469857|183335162|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.352|TWO_SIDED|95.0|0.35|1.46|||Log Rank|||||1.46|0.35|0.352
91721252|NCT02469857|183335163|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.031|TWO_SIDED|95.0|0.04|0.99|||Log Rank|||||0.99|0.04|0.031
91721253|NCT02469857|183335164|SUPERIORITY|||||||0.024|||||||Chi-squared|||||||0.024
91721254|NCT02469857|183335165|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
91527109|NCT02172625|182929539|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|24.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
91689036|NCT01998919|183271445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68|||Wald test|||||0.68|0.33|<0.0001
91689037|NCT01998919|183271446|SUPERIORITY_OR_OTHER|||||||0.5991|||||||Log Rank|||||||0.5991
91689038|NCT01998919|183271446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3774|TWO_SIDED|95.0|0.58|1.23|||Wald test|||||1.23|0.58|0.3774
91689039|NCT00897715|183271447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.||||0.03
91689040|NCT00897715|183271448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||||||0.01
91689041|NCT01641640|183271475|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial exact test|||Superiority would be demonstrated if the SVR12 rate was higher than the 60% null SVR rate based on historical control data.||||< 0.001
91689042|NCT00860795|183271486|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||.17
91689043|NCT00860795|183271487|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Regression, Linear|||||||.72
91689044|NCT00860795|183271488|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Regression, Linear|||||||.2
91689045|NCT00860795|183271490|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|95.0|||||Regression, Linear|||||||.51
91689046|NCT00860795|183271491|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Regression, Linear|||||||.43
91689047|NCT00860795|183271492|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||.61
91721255|NCT02469857|183335166|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
91721256|NCT02469857|183335167|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
91721257|NCT03416179|183335186|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6579|TWO_SIDED|95.0|0.755|1.532|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio less than (\<) 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2 compared to Placebo + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2.||1.532|0.755|0.6579
91721258|NCT03416179|183335187|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5955|TWO_SIDED|95.0|0.775|1.388|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO QD + Azacitidine compared to Placebo + Azacitidine||1.388|0.775|0.5955
91721259|NCT03416179|183335188|OTHER|||||||0.5095|||||||Mantel Haenszel|||||||0.5095
91721260|NCT03416179|183335189|OTHER|||||||0.8359|||||||Mantel Haenszel|||||||0.8359
91721261|NCT00879658|183335231|SUPERIORITY||Negative binomial regression model|0.524||||0.148|TWO_SIDED|95.0|0.219|1.257||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||An ARR-ratio \<1 favors active treatment.|1.257|0.219|0.148
91689048|NCT02792517|183271508|OTHER||Least Squares Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.88|1.22|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.22|0.88|
91689049|NCT02792517|183271509|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.14|0.91|
91689050|NCT02792517|183271510|OTHER||Least Squares Geometric Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.16|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.16|0.97|
91689051|NCT02792517|183271511|OTHER||Least Squares Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.96|1.1|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.10|0.96|
91689052|NCT02792517|183271512|OTHER||Least Squares Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.9|1.23|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.23|0.90|
91689053|NCT02792517|183271513|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.94|1.12|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.12|0.94|
91689054|NCT01958437|183271563|SUPERIORITY|||||||0.048|||||||ANCOVA|||RM ANCOVA (covarying order) for cognitively intact groups||||.048
91689055|NCT01958437|183271563|SUPERIORITY|||||||0.063|||||||ANCOVA|||RM ANCOVA (covarying order) for MCI group||||.063
91689056|NCT01958437|183271564|SUPERIORITY|||||||0.27|||||||ANCOVA|Main effect of stimulation covarying session order||Change between active and sham tDCS sessions for allocentric blocks||||.27
91689057|NCT01958437|183271564|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
91689058|NCT01958437|183271565|SUPERIORITY||||||<|0.001|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||<.001
91527110|NCT03445065|182929540|SUPERIORITY||Mean Difference (Net)|-0.1||||0.341|TWO_SIDED|95.0|-0.4|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm, centre, and type of diabetes as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.1|-0.4|0.341
91689059|NCT01958437|183271565|SUPERIORITY|||||||0.046|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||.046
91689060|NCT01958437|183271566|SUPERIORITY|||||||0.497|||||||ANCOVA|||Repeated Measures ANCOVA (covarying stimulation order)||||.497
91689061|NCT01958437|183271566|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||.599
91689062|NCT02200055|183271577|SUPERIORITY_OR_OTHER|This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.|Mean Difference (Final Values)|0.53|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
91689063|NCT03535740|183271591|OTHER|||||||0.0763||||||P-value was based on the comparison of the confirm ORR among the 90/180mg group against a fixed response rate of 20%.|Exact Binomial Test|The calculation was based on an exact binomial test with a total 1-sided alpha level of 0.025 at primary analysis.||||||0.0763
91689064|NCT05317312|183271627|SUPERIORITY||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|12.08||0.123|TWO_SIDED|95.0|-5.2|42.7|||Emax||The estimated difference between 1.25mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||42.7|-5.2|0.123
91689065|NCT05317312|183271627|SUPERIORITY||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|10.25|<|0.001|TWO_SIDED|95.0|14.4|55.0|||Emax||||The estimated difference between 5mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|55.0|14.4|<0.001
91689066|NCT05317312|183271627|SUPERIORITY||Mean Difference (Final Values)|42.8|STANDARD_ERROR_OF_MEAN|9.53|<|0.001|TWO_SIDED|95.0|23.9|61.7|||Emax||The estimated difference between 15mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||61.7|23.9|<0.001
91689067|NCT05317312|183271628|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.0|0.2|||||The estimated difference between 1.5mg bid and placebo is based on Mixed Model Repeated Measures.The values in the Outcome Measure Data are observed mean values.|||0.2|-2.0|
91689068|NCT05317312|183271628|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.8|0.4|||||The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values|||0.4|-1.8|
91689069|NCT05317312|183271628|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.9|0.3|||||The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values|||0.3|-1.9|
91689070|NCT05317312|183271629|SUPERIORITY|||||||0.036|||||||Log Rank|||||||0.036
91689071|NCT05317312|183271629|SUPERIORITY|||||||0.006|||||||Log Rank|||||||0.006
91689072|NCT05317312|183271629|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91689073|NCT05317312|183271630|SUPERIORITY|||||||0.411|||||||Log Rank|||||||0.411
91689074|NCT05317312|183271630|SUPERIORITY|||||||0.383|||||||Log Rank|||||||0.383
91689075|NCT05317312|183271630|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91689076|NCT05317312|183271631|SUPERIORITY||Risk Difference (RD)|27.4||||0.042|TWO_SIDED|95.0|2.0|52.7|||Chi-squared|||||52.7|2.0|0.042
91689077|NCT05317312|183271631|SUPERIORITY||Risk Difference (RD)|34.5||||0.01|TWO_SIDED|95.0|9.7|59.3|||Chi-squared|||||59.3|9.7|0.01
91689078|NCT05317312|183271631|SUPERIORITY||Risk Difference (RD)|51.9|||<|0.001|TWO_SIDED|95.0|29.6|74.1|||Chi-squared|||||74.1|29.6|<0.001
91689079|NCT05317312|183271632|SUPERIORITY||Risk Difference (RD)|-31.2||||0.019|TWO_SIDED|95.0|-55.9|-6.5|||Chi-squared|||||-6.5|-55.9|0.019
91689080|NCT05317312|183271632|SUPERIORITY||Risk Difference (RD)|-16.9||||0.187|TWO_SIDED|95.0|-41.6|7.8|||Chi-squared|||||7.8|-41.6|0.187
91689081|NCT05317312|183271632|SUPERIORITY||Risk Difference (RD)|-44.4||||0.001|TWO_SIDED|95.0|-68.3|20.6|||Chi-squared|||||20.6|-68.3|0.001
91721262|NCT00879658|183335231|SUPERIORITY||Negative binomial regression model|0.34||||0.041|TWO_SIDED|95.0|0.121|0.956||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||0.956|0.121|0.041
91721263|NCT00879658|183335231|SUPERIORITY||Negative binomial regression model|1.051||||0.899|TWO_SIDED|95.0|0.486|2.273||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||2.273|0.486|0.899
91689082|NCT02015611|183271638|SUPERIORITY|||||||0.63|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.63
91689083|NCT02015611|183271639|SUPERIORITY|||||||0.64|||||||Regression, Linear|adjusted for age, sex, race, season, and baseline value||||||0.64
91689084|NCT02015611|183271640|SUPERIORITY|||||||0.08|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.08
91689085|NCT02015611|183271641|SUPERIORITY|||||||0.53|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.53
91689086|NCT02015611|183271642|SUPERIORITY|||||||0.75|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.75
91689087|NCT02015611|183271643|SUPERIORITY|||||||0.92|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.92
91689088|NCT02015611|183271644|SUPERIORITY|||||||0.94|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.94
91689089|NCT02015611|183271645|SUPERIORITY|||||||0.61|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.61
91689090|NCT02015611|183271646|SUPERIORITY|||||||0.59|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.59
91689091|NCT02015611|183271647|SUPERIORITY|||||||0.21|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.21
91689092|NCT00951496|183271654|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.94||||0.341|TWO_SIDED|95.0|0.81|1.09||P value not adjusted for multiplicity. Significance Threshold = 0.027|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.|P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I||1.09|0.81|0.341
91689093|NCT00951496|183271654|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.99||||0.587|TWO_SIDED|95.0|0.86|1.15||P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.|P value from a log rank test comparing the progression free survival hazards of arm III to arm I.||1.15|0.86|0.587
91689094|NCT00395161|183271678|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Log Rank|Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)||Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).||||0.29
91721264|NCT00879658|183335232|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.915||||0.879|TWO_SIDED|95.0|0.288|2.925|||Regression, Logistic|"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."||||2.925|0.288|0.879
91721265|NCT00879658|183335232|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.745||||0.399|TWO_SIDED|95.0|0.484|7.167||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||7.167|0.484|0.399
91721266|NCT00879658|183335232|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.697||||0.454|TWO_SIDED|95.0|0.438|8.296||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||8.296|0.438|0.454
91527111|NCT03445065|182929541|SUPERIORITY||Mean Difference (Net)|-1.6||||0.03892|TWO_SIDED|95.0|-3.1|-0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.1|-3.1|0.03892
91689095|NCT00395161|183271679|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Rate analysis (see comments)|95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.||Null hypothesis of equal event rates in the two study arms.||||0.81
91689096|NCT00395161|183271680|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
91689097|NCT00395161|183271681|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Chi-squared|||||||0.07
91689098|NCT00395161|183271682|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
91689099|NCT01610492|183271687|OTHER||Geometric Mean|0.76|||||TWO_SIDED|95.0|0.57|1.01||||||||1.01|0.57|
91689100|NCT01610492|183271688|OTHER||Geometric Mean|0.27|||||TWO_SIDED|95.0|0.12|0.58||||||||0.58|0.12|
91721267|NCT00879658|183335232|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.509||||0.223|TWO_SIDED|95.0|0.166|1.511||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||1.511|0.166|0.223
91721268|NCT00879658|183335232|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.785||||0.668|TWO_SIDED|95.0|0.253|2.392||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||2.392|0.253|0.668
91721269|NCT00879658|183335233|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.996||||0.178|TWO_SIDED|95.0|0.731|5.669|||Regression, Logistic|Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.||||5.669|0.731|0.178
91721270|NCT00879658|183335233|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|4.12||||0.014|TWO_SIDED|95.0|1.328|14.681||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||14.681|1.328|0.014
91721271|NCT00879658|183335233|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.266||||0.642|TWO_SIDED|95.0|0.468|3.494||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||3.494|0.468|0.642
91721272|NCT00879658|183335234|SUPERIORITY||lesion ratio|0.138|||<|0.001|TWO_SIDED|95.0|0.047|0.408|||Regression, Logistic|new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.408|0.047|<0.001
91721273|NCT00879658|183335234|SUPERIORITY||lesion ratio|0.307||||0.012|TWO_SIDED|95.0|0.123|0.771||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.771|0.123|0.012
91721274|NCT00879658|183335234|SUPERIORITY||lesion ratio|0.113|||<|0.001|TWO_SIDED|95.0|0.036|0.358||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.358|0.036|<0.001
91721275|NCT00879658|183335234|SUPERIORITY||lesion ratio|0.375||||0.021|TWO_SIDED|95.0|0.163|0.86||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.860|0.163|0.021
91721276|NCT00879658|183335234|SUPERIORITY||lesion ratio|0.478||||0.062|TWO_SIDED|95.0|0.22|1.037||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.037|0.220|0.062
91721277|NCT00879658|183335235|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|Lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.063|0.376|||Regression, Logistic|new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||||0.376|0.063|<0.001
91488531|NCT01601132|182849470|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.86|||||TWO_SIDED|90.0|101.77|110.12|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Cmax, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Cmax to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, (AUC0-∞), and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||110.12|101.77|
91488532|NCT01601132|182849471|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.63|||||TWO_SIDED|90.0|101.81|109.59|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-t)\], expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-t) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||109.59|101.81|
91527112|NCT03445065|182929545|SUPERIORITY||Mean Difference (Net)|5.4||||0.056|TWO_SIDED|95.0|-0.1|10.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||10.9|-0.1|0.056
91488533|NCT01601132|182849472|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|106.43|||||TWO_SIDED|90.0|101.1|112.04|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-∞) , expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-∞) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||112.04|101.10|
91721278|NCT00879658|183335235|SUPERIORITY||lesion ratio|0.228||||0.005|TWO_SIDED|95.0|0.081|0.641||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.641|0.081|0.005
91721279|NCT00879658|183335235|SUPERIORITY||lesion ratio|0.188|||<|0.001|TWO_SIDED|95.0|0.07|0.509||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.509|0.070|<0.001
91721280|NCT00879658|183335236|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.279||||0.002|TWO_SIDED|95.0|0.124|0.628||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.628|0.124|0.002
91721281|NCT00879658|183335236|SUPERIORITY||lesion ratio|0.396||||0.019|TWO_SIDED|95.0|0.182|0.861||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.861|0.182|0.019
91721282|NCT00879658|183335236|SUPERIORITY||lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.059|0.4||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.400|0.059|<0.001
91721283|NCT00879658|183335236|SUPERIORITY||lesion ratio|0.454||||0.035|TWO_SIDED|95.0|0.219|0.945||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.945|0.219|0.035
91689101|NCT02575833|183271728|NON_INFERIORITY|The non-inferiority margin was -90 seconds.|Treatment Difference|-11.0|STANDARD_ERROR_OF_MEAN|20.4|||TWO_SIDED|90.0|-44.9|22.9||||||The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (\< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.||22.9|-44.9|
91721284|NCT00879658|183335236|SUPERIORITY||lesion ratio|0.555||||0.087|TWO_SIDED|96.0|0.283|1.09||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.090|0.283|0.087
91527113|NCT03445065|182929545|SUPERIORITY||Mean Difference (Net)|4.7||||0.01255|TWO_SIDED|95.0|1.0|8.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||8.4|1.0|0.01255
91689102|NCT02575833|183271729|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|1.55||||0.69|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.69
91689103|NCT02575833|183271729|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.69|TWO_SIDED|90.0|0.73|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.69|0.73|0.69
91689104|NCT02575833|183271729|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.44|TWO_SIDED|90.0|0.52|1.26|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.26|0.52|0.44
91689105|NCT02575833|183271729|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|90.0|0.52|1.28|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.28|0.52|0.47
91488534|NCT01601132|182849473|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|93.96|||||TWO_SIDED|90.0|89.25|98.92|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed CL/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed CL/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||98.92|89.25|
91488535|NCT01601132|182849474|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|98.59|||||TWO_SIDED|90.0|90.97|106.85|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Vd/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Vd/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||106.85|90.97|
91488536|NCT02110238|182849475|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A VAS (0-100 mm) WOMAC Pain subscale score CFB; an equal n t-test for non-inferiority of means; a non-inferiority margin of -8 mm; change standard deviation of 26 mm; two-sided alpha=0.05; 80% power; an expected mean difference of 0, and a drop-out plus important deviation percentage of approximately 20% were used to establish study sample size.|Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.77|0.17|||||"A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 single point estimate least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated."|||0.17|-6.77|
91488537|NCT03228433|182849486|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).|Least Squares (LS) Mean Difference|0.951|||||TWO_SIDED|90.0|0.823|1.099||||||||1.099|0.823|
91689106|NCT02575833|183271730|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|2.2||||0.59|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.59
91689107|NCT02575833|183271730|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|90.0|0.76|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.69|0.76|0.59
91689108|NCT02575833|183271730|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|90.0|0.73|1.6|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.60|0.73|0.75
91689109|NCT02575833|183271730|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.39|TWO_SIDED|90.0|0.82|1.87|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.87|0.82|0.39
91689110|NCT04211831|183271747|OTHER||Least square mean difference|-1.29|||=|0.1722|TWO_SIDED|95.0|-3.16|0.58|||mixed model for repeated measures||Treatment comparison between Placebo and URO-902 24 mg using least sqaure mean difference and 95% confidence interval (CI) has been presented.|||0.58|-3.16|=0.1722
91527114|NCT03445065|182929546|SUPERIORITY||Mean Difference (Net)|-5.5||||0.015|TWO_SIDED|95.0|-9.9|-1.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>250mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-1.1|-9.9|0.015
91689111|NCT04211831|183271747|OTHER||Least Square Mean Difference|-2.24|||=|0.0159|TWO_SIDED|95.0|-4.04|-0.43|||Mixed model for repeated measures||Treatment comparison between Placebo and URO-902 48 mg using least sqaure mean difference and 95% CI has been presented.|||-0.43|-4.04|=0.0159
91689112|NCT00967330|183271749|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
91689113|NCT00967330|183271750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.588||||0.0012|TWO_SIDED|95.0|0.423|0.817|||Chi-squared|||||0.817|0.423|0.0012
91689114|NCT00967330|183271751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8283|TWO_SIDED|95.0|0.684|1.354|||Chi-squared|||||1.354|0.684|0.8283
91689115|NCT00967330|183271753|SUPERIORITY_OR_OTHER||Difference in response rate|0.06||||0.34745|TWO_SIDED|95.0|-0.02|0.14|||Fisher Exact|||Response rate based on participants with CR at 4 weeks after RT.||0.14|-0.02|0.34745
91689116|NCT00967330|183271753|SUPERIORITY_OR_OTHER||Difference in response rate|0.09||||0.17923|TWO_SIDED|95.0|0.0|0.17|||Fisher Exact|||The response rate based on participants with CR at \>4 weeks after RT.||0.17|0.00|0.17923
91689117|NCT00967330|183271753|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||1|TWO_SIDED|95.0|-0.08|0.08|||Fisher Exact|||The response rate based on participants with CR at Month 6.||0.08|-0.08|1.00000
91689118|NCT00967330|183271753|SUPERIORITY_OR_OTHER||Difference in response rate|0.25||||0.0021|TWO_SIDED|95.0|0.12|0.38|||Fisher Exact|||Response rate based on participants with CR or PR at 4 weeks after RT.||0.38|0.12|0.00210
91721285|NCT00879658|183335237|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.095|||<|0.001|TWO_SIDED|95.0|0.033|0.273||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.273|0.033|<0.001
91721286|NCT00879658|183335237|SUPERIORITY||lesion ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.069|0.47||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.470|0.069|<0.001
91721287|NCT00879658|183335237|SUPERIORITY||lesion ratio|0.173|||<|0.001|TWO_SIDED|95.0|0.069|0.434||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.434|0.069|<0.001
91721288|NCT00879658|183335238|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.259||||0.005|TWO_SIDED|95.0|0.1|0.67||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.670|0.100|0.005
91721289|NCT00879658|183335238|SUPERIORITY||lesion ratio|0.276||||0.005|TWO_SIDED|95.0|0.112|0.676||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.676|0.112|0.005
91721290|NCT00879658|183335238|SUPERIORITY||lesion ratio|0.118|||<|0.001|TWO_SIDED|95.0|0.034|0.409||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.409|0.034|<0.001
91721291|NCT00879658|183335238|SUPERIORITY||lesion ratio|0.683||||0.485|TWO_SIDED|95.0|0.234|1.991||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.991|0.234|0.485
91721292|NCT00879658|183335238|SUPERIORITY||lesion ratio|0.591||||0.142|TWO_SIDED|95.0|0.292|1.193||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.193|0.292|0.142
91689119|NCT00967330|183271753|SUPERIORITY_OR_OTHER||Difference in response rate|0.1||||0.18761|TWO_SIDED|95.0|-0.02|0.23|||Fisher Exact|||Response rate based on participants with CR and PR at \>4 weeks after RT.||0.23|-0.02|0.18761
91689120|NCT00967330|183271753|SUPERIORITY_OR_OTHER||Difference in response rate|-0.05||||0.38974|TWO_SIDED|95.0|-0.18|0.07|||Fisher Exact|||Response rate based on participants with CR or PR at Month 6.||0.07|-0.18|0.38974
91689121|NCT00967330|183271755|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|2.1002||||0.4975|TWO_SIDED|95.0|-3.9855|8.186|||ANOVA|||Physical Functioning. Analysis of variance (ANOVA) included all post-baseline data (Months 3 through 21).||8.1860|-3.9855|0.4975
91721293|NCT00879658|183335239|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.161|||<|0.001|TWO_SIDED|95.0|0.062|0.421||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.421|0.062|<0.001
91721294|NCT00879658|183335239|SUPERIORITY||lesion ratio|0.197||||0.001|TWO_SIDED|95.0|0.074|0.527||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.527|0.074|0.001
91689122|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4704||||0.76|TWO_SIDED|95.0|-10.9358|7.9951|||ANOVA|||Role Functioning. ANOVA included all post-baseline data (Months 3 through 21).||7.9951|-10.9358|0.7600
91689123|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02278||||0.9949|TWO_SIDED|95.0|-7.035|6.9895|||ANOVA|||Emotional Functioning. ANOVA included all post-baseline data (Months 3 through 21).||6.9895|-7.0350|0.9949
91689124|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8213||||0.6253|TWO_SIDED|95.0|-9.155|5.5125|||ANOVA|||Cognitive Functioning. ANOVA included all post-baseline data (Months 3 through 21).||5.5125|-9.1550|0.6253
91721295|NCT00879658|183335239|SUPERIORITY||lesion ratio|0.416||||0.139|TWO_SIDED|95.0|0.13|1.331||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.331|0.130|0.139
91721296|NCT00879658|183335240|SUPERIORITY|||||||0.227||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.227
91721297|NCT00879658|183335240|SUPERIORITY|||||||0.02||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.020
91721298|NCT00879658|183335240|SUPERIORITY|||||||0.001||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.001
91721299|NCT00879658|183335240|SUPERIORITY|||||||0.122||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.122
91721300|NCT00879658|183335240|SUPERIORITY|||||||0.034||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.034
91721301|NCT00879658|183335241|SUPERIORITY|||||||0.335||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.335
91721302|NCT00879658|183335241|SUPERIORITY|||||||0.022||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.022
91721303|NCT00879658|183335241|SUPERIORITY|||||||0.124||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.124
91721304|NCT00879658|183335242|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.129||||0.006|TWO_SIDED|95.0|0.03|0.561||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.561|0.030|0.006
91721305|NCT00879658|183335242|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.159||||0.005|TWO_SIDED|95.0|0.044|0.578||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.578|0.044|0.005
91721306|NCT00879658|183335242|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.052||||0.005|TWO_SIDED|95.0|0.007|0.405||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.405|0.007|0.005
91721307|NCT00879658|183335242|SUPERIORITY||lesion ratio|0.271||||0.019|TWO_SIDED|95.0|0.091|0.807||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.||0.807|0.091|0.019
91721308|NCT00879658|183335242|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.504||||0.169|TWO_SIDED|95.0|0.19|1.337||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||1.337|0.190|0.169
91721309|NCT00879658|183335243|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.214|||<|0.001|TWO_SIDED|95.0|0.091|0.499||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.499|0.091|<0.001
91721310|NCT00879658|183335243|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.24||||0.018|TWO_SIDED|95.0|0.074|0.779||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.779|0.074|0.018
91527115|NCT03445065|182929546|SUPERIORITY||Mean Difference (Net)|-1.0||||0.50266|TWO_SIDED|95.0|-4.0|2.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||2.0|-4.0|0.50266
91721311|NCT00879658|183335243|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.231||||0.006|TWO_SIDED|95.0|0.081|0.653||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.653|0.081|0.006
91721312|NCT00157755|183335254|SUPERIORITY_OR_OTHER|||||||0.215||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.215
91721313|NCT00157755|183335254|SUPERIORITY_OR_OTHER|||||||1||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||1.0
91721314|NCT00157755|183335255|SUPERIORITY_OR_OTHER|||||||0.903||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.903
91721315|NCT00157755|183335255|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.932
91721316|NCT00157755|183335256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
91721317|NCT00157755|183335256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
91721318|NCT00157755|183335257|SUPERIORITY_OR_OTHER|||||||0.014||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||0.014
91488538|NCT03228433|182849486|EQUIVALENCE|A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.14|||||TWO_SIDED|90.0|1.04|1.25||||||||1.25|1.04|
91488539|NCT03228433|182849487|EQUIVALENCE|Bioequivalence interval of 627.51 to 659.59|LS Mean Difference|0.951|||||TWO_SIDED|90.0|0.825|1.097||||||||1.097|0.825|
91689125|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6126||||0.7219|TWO_SIDED|95.0|-7.2953|10.5205|||ANOVA|||Social Functioning. ANOVA included all post-baseline data (Months 3 through 21).||10.5205|-7.2953|0.7219
91689126|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4989||||0.2443|TWO_SIDED|95.0|-2.4046|9.4023|||ANOVA|||Global Health Status /QoL. ANOVA included all post-baseline data (Months 3 through 21).||9.4023|-2.4046|0.2443
91689127|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3449||||0.3287|TWO_SIDED|95.0|-10.0739|3.3841|||ANOVA|||Fatigue. ANOVA included all post-baseline data (Months 3 through 21).||3.3841|-10.0739|0.3287
91689128|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.196||||0.0485|TWO_SIDED|95.0|-8.3635|-0.0285|||ANOVA|||Nausea/Vomiting. ANOVA included all post-baseline data (Months 3 through 21).||-0.02850|-8.3635|0.0485
91721319|NCT00157755|183335257|SUPERIORITY_OR_OTHER||||||<|0.001||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||<0.001
91721320|NCT00157755|183335258|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
91721321|NCT00157755|183335258|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
91721322|NCT00157755|183335259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||<0.001
91721323|NCT00157755|183335259|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||0.043
91488540|NCT03228433|182849487|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.11|||||TWO_SIDED|90.0|1.0|1.22||||||||1.22|1.00|
91689129|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.095||||0.0354|TWO_SIDED|95.0|-17.5629|-0.6271|||ANOVA|||Pain. ANOVA included all post-baseline data (Months 3 through 21).||-0.6271|-17.5629|0.0354
91689130|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2088||||0.3724|TWO_SIDED|95.0|-10.2784|3.8608|||ANOVA|||Dyspnoea. ANOVA included all post-baseline data (Months 3 through 21).||3.8608|-10.2784|0.3724
91689131|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.876||||0.2884|TWO_SIDED|95.0|-13.9002|4.1482|||ANOVA|||Insomnia. ANOVA included all post-baseline data (Months 3 through 21).||4.1482|-13.9002|0.2884
91689132|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.782||||0.4081|TWO_SIDED|95.0|-9.3926|3.8282|||ANOVA|||Appetite loss. ANOVA included all post-baseline data (Months 3 through 21).||3.8282|-9.3926|0.4081
91689133|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9375||||0.275|TWO_SIDED|95.0|-11.0245|3.1495|||ANOVA|||Constipation. ANOVA included all post-baseline data (Months 3 through 21).||3.1495|-11.0245|0.2750
91689134|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1685||||0.0213|TWO_SIDED|95.0|-11.4129|-0.9241|||ANOVA|||Diarrhoea. ANOVA included all post-baseline data (Months 3 through 21).||-0.9241|-11.4129|0.0213
91689135|NCT00967330|183271755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7295||||0.5201|TWO_SIDED|95.0|-11.0727|5.6137|||ANOVA|||Financial Problems. ANOVA included all post-baseline data (Months 3 through 21).||5.6137|-11.0727|0.5201
91689136|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2699||||0.3613|TWO_SIDED|95.0|-10.2983|3.7585|||ANOVA|||Future uncertainty. ANOVA included all post-baseline data (Months 3 through 21).||3.7585|-10.2983|0.3613
91689137|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1159||||0.6146|TWO_SIDED|95.0|-5.4654|3.2336|||ANOVA|||Visual disorder. ANOVA included all post-baseline data (Months 3 through 21).||3.2336|-5.4654|0.6146
91689138|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1014||||0.686|TWO_SIDED|95.0|-4.2449|6.4477|||ANOVA|||Motor dysfunction. ANOVA included all post-baseline data (Months 3 through 21).||6.4477|-4.2449|0.6860
91689139|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1009||||0.9706|TWO_SIDED|95.0|-5.468|5.2663|||ANOVA|||Communication deficit. ANOVA included all post-baseline data (Months 3 through 21).||5.2663|-5.4680|0.9706
91689140|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3294||||0.0124|TWO_SIDED|95.0|-14.855|-1.8037|||ANOVA|||Headaches. ANOVA included all post-baseline data (Months 3 through 21).||-1.8037|-14.8550|0.0124
91689141|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0054||||0.5997|TWO_SIDED|95.0|-4.7654|2.7545|||ANOVA|||Seizures. ANOVA included all post-baseline data (Months 3 through 21).||2.7545|-4.7654|0.5997
91689142|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4399||||0.3458|TWO_SIDED|95.0|-10.6002|3.7204|||ANOVA|||Drowsiness. ANOVA included all post-baseline data (Months 3 through 21).||3.7204|-10.6002|0.3458
91689143|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5908||||0.2383|TWO_SIDED|95.0|-12.2279|3.0464|||ANOVA|||Hair loss. ANOVA included all post-baseline data (Months 3 through 21).||3.0464|-12.2279|0.2383
91689144|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9807||||0.7491|TWO_SIDED|95.0|-5.0373|6.9988|||ANOVA|||Itchy skin. ANOVA included all post-baseline data (Months 3 through 21).||6.9988|-5.0373|0.7491
91689145|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0341||||0.7755|TWO_SIDED|95.0|-8.1508|6.0827|||ANOVA|||Weakness of legs. ANOVA included all post-baseline data (Months 3 through 21).||6.0827|-8.1508|0.7755
91689146|NCT00967330|183271756|SUPERIORITY_OR_OTHER||LS Mean Difference|0.469||||0.841|TWO_SIDED|95.0|-4.1211|5.0591|||ANOVA|||Bladder control. ANOVA included all post-baseline data (Months 3 through 21).||5.0591|-4.1211|0.8410
91689147|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1933||||0.0817|TWO_SIDED|95.0|-0.411|0.02438|||ANOVA|||Orientation to time and place. ANOVA included all post-baseline data (Months 3 through 21).||0.02438|-0.4110|0.0817
91689148|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02955||||0.0773|TWO_SIDED|95.0|-0.06234|0.003241|||ANOVA|||Immediate recall. ANOVA included all post-baseline data (Months 3 through 21).||0.003241|-0.06234|0.0773
91689149|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1429||||0.2608|TWO_SIDED|95.0|-0.1065|0.3924|||ANOVA|||Repetitions required. ANOVA included all post-baseline data (Months 3 through 21).||0.3924|-0.1065|0.2608
91689150|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|0.003262||||0.9836|TWO_SIDED|95.0|-0.3092|0.3158|||ANOVA|||Calculations. ANOVA included all post-baseline data (Months 3 through 21).||0.3158|-0.3092|0.9836
91689151|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03782||||0.661|TWO_SIDED|95.0|-0.2071|0.1315|||ANOVA|||Short-term verbal memory. ANOVA included all post-baseline data (Months 3 through 21).||0.1315|-0.2071|0.6610
91689152|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08037||||0.4464|TWO_SIDED|95.0|-0.2875|0.1268|||ANOVA|||Language and construct ability. ANOVA included all post-baseline data (Months 3 through 21).||0.1268|-0.2875|0.4464
91689153|NCT00967330|183271757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3128||||0.4717|TWO_SIDED|95.0|-1.1658|0.5402|||ANOVA|||Total score. ANOVA included all post-baseline data (Months 3 through 21).||0.5402|-1.1658|0.4717
91689154|NCT00967330|183271758|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.151||||0.2078|TWO_SIDED|95.0|-5.4983|1.1963|||ANOVA|||KPS score. ANOVA included all post-baseline data (Months 3 through 21).||1.1963|-5.4983|0.2078
91689155|NCT00610428|183271762|SUPERIORITY|||||||0.084||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||Survival time is defined as time to the first successful headache relief.||||0.0840
91488541|NCT03228433|182849488|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.|LS Mean Difference|0.58|||||TWO_SIDED|90.0|0.431|0.781||||||||0.781|0.431|
91689156|NCT00610428|183271762|SUPERIORITY|Survival time is defined as time to the first successful headache relief.||||||0.0383||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||||||0.0383
91488542|NCT03228433|182849488|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.06||||||90.0|0.96|1.17||||||||1.17|0.96|
91488543|NCT03055156|182849490|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
91689157|NCT04927845|183271763|SUPERIORITY||between-group effect size Cohen's d|0.24||||0.008|TWO_SIDED|95.0|0.06|0.41|||linear mixed effects, groupXtime term|||||0.41|0.06|.008
91689158|NCT04927845|183271763|SUPERIORITY||Slope|1.75||||0.03|TWO_SIDED||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: comparing the waitlist condition versus only intervention group participants who were program initiators||||.03
91721324|NCT00157755|183335260|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.009
91527116|NCT03445065|182929547|SUPERIORITY||Mean Difference (Net)|-5.1||||0.08|TWO_SIDED|95.0|-10.9|0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>180mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.6|-10.9|0.080
91689159|NCT04927845|183271763|SUPERIORITY|||||||0.009|||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: concurrent service use was added as a covariate to models.||||.009
91689160|NCT04927845|183271764|SUPERIORITY||between-group effect size Cohen's d|0.11||||0.21|TWO_SIDED||||||linear mixed effects, groupXtime term|||||||.21
91689161|NCT04927845|183271765|SUPERIORITY||between-group effect size Cohen's d|0.19||||0.046|TWO_SIDED|95.0|0.02|0.36|||linear mixed effects, groupXtime term|||||0.36|0.02|.046
91689162|NCT05120193|183271766|NON_INFERIORITY|The primary safety analysis is performed at a one-sided Type I error rate of α = 0.05. The Farrington-Manning method is used to calculate the upper 95% confidence bound for the difference (QI - QC) between the rate of the primary safety endpoint in the investigational arm (QI) and the rate of the primary safety endpoint in the control arm (QC). If the upper confidence bound is less than 0.08, the study is considered to have demonstrated safety of the investigational device.|Risk Difference (RD)|0.005|||<|0.0001|TWO_SIDED|90.0|-0.028|0.037|||Farrington-Manning|||"The null hypothesis (H0) for the primary safety analysis is that the true rate of primary safety events for the investigational device (QI) is equal to or greater than the true rate for the control device (QC) plus a non-inferiority margin (NIM) of 0.08. The alternative hypothesis (HA) is that the rate of primary safety events for the investigational arm (QI) is less than the rate of primary safety events for the control arm (QC) plus the NIM of 0.08.~H0: QI ≥ QC + 0.08 HA: QI \< QC + 0.08"||0.037|-0.028|<0.0001
91689163|NCT05120193|183271767|NON_INFERIORITY|The primary effectiveness analysis (PSE) is performed at a one-sided Type I error rate of α = 0.025. The Farrington-Manning method is used to calculate the lower 97.5% confidence bound for the difference (PI - PC) between the rate of the PSE in the investigational arm (PI) and the rate of the PSE in the control arm (PC). If the lower confidence bound is greater than -0.15, the study is considered to have demonstrated effectiveness of the investigational device.|Risk Difference (RD)|0.08||||0.025|TWO_SIDED|95.0|-0.009|0.168|||Farrington-Manning|||"The null hypothesis (H0) is that the true rate of primary effectiveness endpoint success (no failures through Day 360) for the investigational device (PI) is less than or equal to the true rate for the control device (PC) minus the NIM of 0.15. The alternative hypothesis (HA) is that the success rate for the investigational arm (PI) is greater than the success rate for the control device (PC) minus the NIM of 0.15.~H0: PI ≤ PC - 0.15 HA: PI \> PC - 0.15"||0.168|-0.009|0.025
91689164|NCT05120193|183271768|SUPERIORITY||Mean Difference (Final Values)|-29.2|||<|0.0001|TWO_SIDED|95.0|-31.7|-26.8|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean total energy application time during the ablation procedure for the investigational device (ETI) is greater than or equal to the mean time for the control device (ETC). The alternative hypothesis (HA) is that the mean total energy application time for the investigational device is less.~H0: ETI ≥ ETC versus HA: ETI \< ETC"||-26.8|-31.7|<0.0001
91689165|NCT05120193|183271769|SUPERIORITY||Mean Difference (Final Values)|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.2|-21.4|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean treatment time for the investigational device (TTI) is greater than or equal to the mean treatment time for the control device (TTC). The alternative hypothesis (HA) is that the mean treatment time for the investigational device is less.~H0: TTI ≥ TTC versus HA: TTI \< TTC"||-21.4|-32.2|<0.0001
91689166|NCT05120193|183271770|SUPERIORITY||Mean Difference (Final Values)|-25.1||||0.025|TWO_SIDED|95.0|-33.0|-17.3|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean procedure time for the investigational device (PTI) is greater than or equal to the mean procedure time for the control device (PTC). The alternative hypothesis (HA) is that the mean procedure time for the investigational device is less.~H0: PTI ≥ PTC versus HA: PTI \< PTC"||-17.3|-33.0|0.025
91689167|NCT04796961|183271771|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|0.1|0.7||||||||0.7|0.1|
91689168|NCT04796961|183271772|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-0.1|1.1||||||smoking screening||1.1|-0.1|
91689169|NCT04796961|183271772|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.1|1.2||||||readiness to quit assessments||1.2|-0.1|
91488544|NCT03055156|182849491|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91488545|NCT03055156|182849492|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91488546|NCT03055156|182849493|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91488547|NCT03055156|182849494|OTHER|||||||0.02|||||||t-test, 2 sided|||Analysis of Wake values||||0.02
91488548|NCT03055156|182849494|OTHER|||||||0.06|||||||t-test, 2 sided|||Analysis of REM values||||0.06
91488549|NCT03055156|182849494|OTHER|||||||0.83|||||||t-test, 2 sided|||Analysis of Non REM stage 1 values||||0.83
91488550|NCT03055156|182849494|OTHER|||||||0.87|||||||t-test, 2 sided|||Analysis of Non REM stage 2 values||||0.87
91488551|NCT03055156|182849494|OTHER|||||||0.97|||||||t-test, 2 sided|||Analysis of Non REM stage 3 values||||0.97
91488552|NCT03055156|182849495|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
91689170|NCT04796961|183271772|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|0.8|2.0||||||smoking cessation counseling||2.0|0.8|
91488553|NCT03055156|182849496|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
91488554|NCT03055156|182849498|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
91488555|NCT03055156|182849499|OTHER|||||||0.86|||||||t-test, 2 sided|||analysis of 0-90 minutes||||0.86
91488556|NCT03055156|182849499|OTHER|||||||0.29|||||||t-test, 2 sided|||analysis of 90-180 minutes||||0.29
91527117|NCT03445065|182929547|SUPERIORITY||Mean Difference (Net)|-3.3||||0.10637|TWO_SIDED|95.0|-7.3|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-7.3|0.10637
91689171|NCT04796961|183271772|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||smoking cessation pharmacotherapy||1.7|-0.5|
91689172|NCT03848715|183271784|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||.16
91721325|NCT00157755|183335260|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.001
91689173|NCT00931528|183271844|SUPERIORITY_OR_OTHER||Difference in percentages|5.0||||0.49|TWO_SIDED|95.0|1.0|9.0|||Chi-squared|||Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.||9|1|0.49
91689174|NCT00931528|183271844|SUPERIORITY|||||||0.2386|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.2386
91689175|NCT00931528|183271844|SUPERIORITY|||||||0.7908|||||||Regression, Linear|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.||||0.7908
91488557|NCT03055156|182849499|OTHER|||||||0.58|||||||t-test, 2 sided|||analysis of 180-270 minutes||||0.58
91488558|NCT03055156|182849499|OTHER|||||||0.62|||||||t-test, 2 sided|||analysis of 270-360 min||||0.62
91488559|NCT03055156|182849500|OTHER|||||||0.389|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.||||0.389
91488560|NCT03055156|182849500|OTHER|||||||0.01|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.||||0.01
91488561|NCT03055156|182849500|OTHER|||||||0.642|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.||||0.642
91488562|NCT03055156|182849501|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
91488563|NCT03055156|182849502|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
91488564|NCT03055156|182849503|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
91488565|NCT01419626|182849508|SUPERIORITY||Difference in LS mean|-0.461|||<|0.001|TWO_SIDED|95.0|-0.581|-0.341|||ANCOVA|||Statistical analysis at Week 4||-0.341|-0.581|<0.001
91488566|NCT01419626|182849508|SUPERIORITY||Difference in LS mean|-0.669|||<|0.001|TWO_SIDED|95.0|-0.789|-0.549|||ANCOVA|||Statistical analysis at Week 4||-0.549|-0.789|<0.001
91488567|NCT01419626|182849508|SUPERIORITY|Statistical analysis at Week 4|Difference in LS mean|-0.208|||<|0.001|TWO_SIDED|95.0|-0.326|-0.09|||ANCOVA|||||-0.090|-0.326|<0.001
91488568|NCT01419626|182849509|SUPERIORITY||Difference in LS mean|-0.494|||<|0.001|TWO_SIDED|95.0|-0.625|-0.363|||ANCOVA|||Statistical analysis at Week 4||-0.363|-0.625|<0.001
91488569|NCT01419626|182849509|SUPERIORITY||Difference in LS mean|-0.697|||<|0.001|TWO_SIDED|95.0|-0.828|-0.567|||ANCOVA|||Statistical analysis at Week 4||-0.567|-0.828|<0.001
91488570|NCT01419626|182849509|SUPERIORITY||Difference in LS mean|-0.203||||0.002||95.0|-0.333|-0.074|||ANCOVA|||Statistical analysis at Week 4||-0.074|-0.333|0.002
91488571|NCT01419626|182849510|SUPERIORITY||Difference in LS mean|-0.04|||<|0.001|TWO_SIDED|95.0|-0.059|-0.021|||ANCOVA|||Statistical analysis at Week 2||-0.021|-0.059|<0.001
91488572|NCT01419626|182849510|SUPERIORITY||Difference in LS mean|-0.044|||<|0.001||95.0|-0.064|-0.025|||ANCOVA|||Statistical analysis at Week 2||-0.025|-0.064|<0.001
91488573|NCT01419626|182849510|SUPERIORITY||Difference in LS mean|-0.004||||0.671|TWO_SIDED|95.0|-0.023|0.015|||ANCOVA|||Statistical analysis at Week 2||0.015|-0.023|0.671
91488574|NCT01419626|182849510|SUPERIORITY||Difference in LS mean|-0.091|||<|0.001|TWO_SIDED|95.0|-0.121|-0.061|||ANCOVA|||Statistical analysis at Week 4||-0.061|-0.121|<0.001
91689176|NCT00931528|183271844|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.0467
91689177|NCT00931528|183271844|SUPERIORITY|||||||0.0068|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.0068
91689178|NCT00931528|183271845|SUPERIORITY|||||||0.93|||||||Chi-squared|2-sided significance level = 0.05||Year 1||||0.93
91689179|NCT00931528|183271845|SUPERIORITY|||||||0.58|||||||Chi-squared|2-sided significance level = 0.05||Year 2||||0.58
91689180|NCT00931528|183271845|SUPERIORITY|||||||0.9501|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.9501
91721326|NCT00157755|183335261|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
91721327|NCT00157755|183335261|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
91721328|NCT00157755|183335262|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.016
91689181|NCT00931528|183271845|SUPERIORITY|||||||0.102|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.1020
91689182|NCT00931528|183271845|SUPERIORITY|||||||0.1855|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.1855
91689183|NCT00931528|183271845|SUPERIORITY|||||||0.5739|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.5739
91721329|NCT00157755|183335262|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.236
91721330|NCT01719653|183335263|OTHER||||||<|0.005||||||Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.005
91721331|NCT01719653|183335264|OTHER||||||<|0.001||||||1 was lower than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.001
91721332|NCT01719653|183335265|OTHER||||||>|0.005|||||||Chi-squared|||All 5 arms were compared pair-wise.||||>0.005
91721333|NCT02421939|183335266|OTHER||Hazard Ratio (HR)|0.637||||0.0004|TWO_SIDED|95.0|0.49|0.83||1-sided P-value|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm|Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.||0.830|0.490|0.0004
91721334|NCT02421939|183335268|OTHER||Hazard Ratio (HR)|0.793||||0.0415|TWO_SIDED|95.0|0.577|1.089||1-sided P-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT||1.089|0.577|0.0415
91721335|NCT02421939|183335269|OTHER||Adjusted Treatment Difference|10.6||||0.0106|TWO_SIDED|95.0|2.8|18.4||Stratified P-value|Cochran-Mantel-Haenszel|||Based on stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Treatment difference = gilteritinib -chemotherapy.||18.4|2.8|0.0106
91721336|NCT02421939|183335270|OTHER||Hazard Ratio (HR)|0.889||||0.6654|TWO_SIDED|95.0|0.506|1.563||Unstratified p-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|The LFS was analyzed for participants who achieved remission using the stratified log-rank test with strata to control for response to first-line AML therapy and preselected salvage chemotherapy. Duration of LFS was based on Kaplan-Meier estimates.||1.563|0.506|0.6654
91721337|NCT02421939|183335271|OTHER||Hazard Ratio (HR)|0.206||||0.1189|TWO_SIDED|95.0|0.022|1.886||Unstratified|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.|||1.886|0.022|0.1189
91721338|NCT02421939|183335272|OTHER||Treatment difference|32.5|||<|0.0001|TWO_SIDED|95.0|22.3|42.6||Unstratified 2-sided P-value|2-sided Fisher's exact test|||Treatment difference = gilteritinib - chemotherapy. The 95% CIs were asymptotic confidence limits using the normal approximation to the binomial distribution.||42.6|22.3|<0.0001
91721339|NCT02421939|183335273|OTHER||Treatment Difference|10.2||||0.0333|TWO_SIDED|95.0|1.2|19.1||Unstratified 2-sided P-value.|2-sided Fisher's exact test|Treatment difference = gilteritinib - chemotherapy.||||19.1|1.2|0.0333
91689184|NCT00931528|183271845|SUPERIORITY|||||||0.0422|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.0422
91689185|NCT00931528|183271845|SUPERIORITY|||||||0.5237|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.5237
91721340|NCT02421939|183335274|OTHER||Least Squares Mean Difference|-1.2567||||0|||||||ANCOVA|||C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.0000
91721341|NCT02421939|183335274|OTHER||Least Squares Mean Difference|0.1574||||0.8037|||||||ANCOVA|||C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.8037
91721342|NCT02421939|183335275|OTHER||Adjusted Treatment Difference,|18.6|||<|0.0171|TWO_SIDED|95.0|9.8|27.4||Stratified 1-sided P-value.|Cochran-Mantel-Haenszel|||Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.||27.4|9.8|<0.0171
91721343|NCT04773028|183335281|OTHER||Mean Difference (Final Values)|-93054.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91721344|NCT02966834|183335299|OTHER||Mean Difference (Net)|-0.47|||||TWO_SIDED|95.0|-1.75|0.82||||||||0.82|-1.75|
91721345|NCT02966834|183335299|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.07|0.31||||||||0.31|-2.07|
91721346|NCT02966834|183335299|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.03|0.28||||||||0.28|-2.03|
91721347|NCT02966834|183335299|OTHER||Mean Difference (Net)|-1.13|||||TWO_SIDED|95.0|-2.29|0.03||||||||0.03|-2.29|
91721348|NCT02966834|183335299|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-1.71|0.65||||||||0.65|-1.71|
91721349|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.9|2.3|||||Symptoms|||2.3|-1.9|
91721350|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||||Symptoms|||2.5|-1.5|
91721351|NCT02966834|183335300|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-3.1|0.8|||||Symptoms|||0.8|-3.1|
91721352|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.8|2.0|||||Symptoms|||2.0|-1.8|
91721353|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.0|1.9|||||Symptoms|||1.9|-2.0|
91721354|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.3|2.2|||||Itch|||2.2|-1.3|
91721355|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.8|1.3|||||Itch|||1.3|-1.8|
91721356|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2|||||Itch|||1.2|-1.9|
91721357|NCT02966834|183335300|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.6|0.5|||||Itch|||0.5|-2.6|
91721358|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Itch|||1.3|-1.9|
91721359|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.2|||||Fatigue|||3.2|-4.5|
91721360|NCT02966834|183335300|OTHER||Median Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.8|4.2|||||Fatigue|||4.2|-2.8|
91721361|NCT02966834|183335300|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|0.0|7.0|||||Fatigue|||7.0|0.0|
91689186|NCT00931528|183271845|SUPERIORITY|||||||0.477|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.4770
91689187|NCT00931528|183271846|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.97
91689188|NCT00931528|183271846|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.99
91689189|NCT00931528|183271846|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.24
91689190|NCT00931528|183271847|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.70
91689191|NCT00931528|183271847|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.65
91689192|NCT00931528|183271847|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|Significance level = 0.05||||||0.72
91689193|NCT00931528|183271848|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.14
91689194|NCT00931528|183271848|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.64
91689195|NCT00931528|183271848|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.18
91689196|NCT00931528|183271849|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.67
91689197|NCT00931528|183271849|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.98
91689198|NCT00931528|183271849|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.96
91689199|NCT00931528|183271850|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.86
91689200|NCT00931528|183271850|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.93
91689201|NCT00931528|183271850|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.52
91689202|NCT05842967|183271872|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.57|||||TWO_SIDED|95.0|1.396|1.759|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV A.|||1.759|1.396|
91689203|NCT05842967|183271872|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.52|||||TWO_SIDED|95.0|1.333|1.725|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV B.|||1.725|1.333|
91689204|NCT05842967|183271873|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|5.1|||||TWO_SIDED|95.0|1.2|9.2|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV A.|||9.2|1.2|
91488575|NCT01419626|182849510|SUPERIORITY||Difference in LS mean|-0.144|||<|0.001|TWO_SIDED|95.0|-0.175|-0.114|||ANCOVA|||Statistical analysis at Week 4||-0.114|-0.175|<0.001
91689205|NCT05842967|183271873|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|8.3|||||TWO_SIDED|95.0|4.2|12.6|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV B.|||12.6|4.2|
91689206|NCT03514459|183271891|SUPERIORITY||Prevalence ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.54|2.2|||Poisson regression|Robust standard errors||||2.20|1.54|<0.001
91689207|NCT01321749|183271930|SUPERIORITY_OR_OTHER||||||<|0.05||5.0|||||Log Rank|||||||<0.05
91689208|NCT00970593|183271941|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|95.0|-1.79|0.29||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||0.29|-1.79|
91689209|NCT00970593|183271941|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.543|||TWO_SIDED|95.0|-2.98|-0.83||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-0.83|-2.98|
91689210|NCT00970593|183271941|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.15|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|95.0|-3.06|-1.24||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.24|-3.06|
91689211|NCT00970593|183271942|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.37|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.52|-1.22||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.22|-3.52|
91689212|NCT00970593|183271942|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.18|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-4.16|-2.2||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.20|-4.16|
91689213|NCT00970593|183271942|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.14|STANDARD_ERROR_OF_MEAN|0.437|||TWO_SIDED|95.0|-4.01|-2.28||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.28|-4.01|
91689214|NCT02203357|183271947|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.|ANOVA|||||||<0.05
91689215|NCT01866826|183271952|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
91488576|NCT01419626|182849510|SUPERIORITY||Difference in LS mean|-0.053|||<|0.001|TWO_SIDED|95.0|-0.083|-0.023|||ANCOVA|||Statistical analysis at Week 4||-0.023|-0.083|<0.001
91488577|NCT01419626|182849511|SUPERIORITY||Difference in LS mean|-0.09|||<|0.001|TWO_SIDED|95.0|-0.115|-0.065|||ANCOVA|||Statistical analysis at Week 2||-0.065|-0.115|<0.001
91689216|NCT01866826|183271953|SUPERIORITY|||||||||||||||||We calculated the proportion of pts with elevated viral levels \>50 copies/ml at each phase of the study.|We estimated that four of the seven patients would have an elevation in viral Ribonucleic Acid (RNA) level \>50 copies/ml.|||
91689217|NCT01866826|183271955|SUPERIORITY||Mean Difference (Net)|0.7872|||||TWO_SIDED|||||||||We calculated the percentage of total lymphocytes that were expressing activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the Wilcoxon test to detect differences between the differences in percentages in the control and Rifaximin groups.||||
91689218|NCT01866826|183271955|SUPERIORITY|||||||0.54|||||||Wilcoxon|||We calculated the percentage of total lymphocytes that were expressing the activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the T-test to detect differences between the differences in percentages in the control group and Rifaximin groups.||||0.54
91689219|NCT01999920|183271967|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||.064
91689220|NCT01999920|183271968|SUPERIORITY||Standard error|5.5|STANDARD_ERROR_OF_MEAN|3.13||0.11|TWO_SIDED|95.0|-1.32|12.32|||Mixed Models Analysis|||||12.32|-1.32|0.11
91689221|NCT01999920|183271969|SUPERIORITY||Standard error|0.34|STANDARD_ERROR_OF_MEAN|2.44||0.89|TWO_SIDED|95.0|-4.85|5.53|||Mixed Models Analysis|||Confidence variable||5.53|-4.85|0.89
91689222|NCT01999920|183271969|SUPERIORITY||Standard error|1.18|STANDARD_ERROR_OF_MEAN|4.41||0.79|TWO_SIDED|95.0|-8.21|10.58|||Mixed Models Analysis|||Discomfort with Closeness variable||10.58|-8.21|0.79
91689223|NCT01999920|183271969|SUPERIORITY||Standard error|3.94|STANDARD_ERROR_OF_MEAN|3.79||0.31|TWO_SIDED|95.0|-4.12|12.01|||Mixed Models Analysis|||Relationships as Secondary variable||12.01|-4.12|0.31
91689224|NCT01999920|183271969|SUPERIORITY||Standard error|-2.6|STANDARD_ERROR_OF_MEAN|1.49||0.1|TWO_SIDED|95.0|-5.79|0.58|||Mixed Models Analysis|||Need for Approval variable||0.58|-5.79|0.10
91689225|NCT01999920|183271969|SUPERIORITY||Standard error|0.71|STANDARD_ERROR_OF_MEAN|2.82||0.8|TWO_SIDED|95.0|-5.3|6.72|||Mixed Models Analysis|||Preoccupation with Relationships variable||6.72|-5.30|0.80
91689226|NCT01999920|183271970|SUPERIORITY||Standard error|-19.91|STANDARD_ERROR_OF_MEAN|6.99||0.008|TWO_SIDED|95.0|-34.23|-5.58|||Mixed Models Analysis|||||-5.58|-34.23|0.008
91689227|NCT01999920|183271971|SUPERIORITY||Standard error|3.29|STANDARD_ERROR_OF_MEAN|1.43||0.026|TWO_SIDED|95.0|0.42|6.16|||Mixed Models Analysis|||||6.16|0.42|0.026
91689228|NCT01999920|183271972|SUPERIORITY||Standard error|21.38|STANDARD_ERROR_OF_MEAN|7.65||0.01|TWO_SIDED|95.0|5.64|37.11|||Mixed Models Analysis|||||37.11|5.64|0.01
91689229|NCT02058069|183271975|NON_INFERIORITY_OR_EQUIVALENCE|The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.|Rare Adverse Event Rate|0.0|||||ONE_SIDED|95.0||0.0331|||||If the upper bound is \<0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.|||0.0331||
91689230|NCT02058069|183271977|OTHER|The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).|Alignment Difference <4.38 Degrees|1.0|||||ONE_SIDED|95.0|0.966||||||Estimation Parameter is: proportion of participants with limb alignment difference \<4.38 degrees If the lower bound is \>0.95 then the assessment passes.||||0.966|
91488578|NCT01419626|182849511|SUPERIORITY||Difference in LS mean|-0.164|||<|0.001|TWO_SIDED|95.0|-0.189|-0.138|||ANCOVA|||Statistical analysis at Week 2||-0.138|-0.189|<0.001
91488579|NCT01419626|182849511|SUPERIORITY||Difference in LS mean|-0.073|||<|0.001|TWO_SIDED|95.0|-0.099|-0.048|||ANCOVA|||Statistical analysis at Week 2||-0.048|-0.099|<0.001
91689231|NCT02058069|183271978|NON_INFERIORITY|The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.|Mean Difference (Final Values)|-33.1|||<|0.001|ONE_SIDED|95.0||-29.6|||t-test, 2 sided||If the upper bound is less than -9, then non-inferiority holds.|Change from pre-op to 3 months||-29.6||<0.001
91689232|NCT02222922|183272024|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|79.38||||0.3105|TWO_SIDED|90.0|54.01|116.65|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||116.65|54.01|0.3105
91689233|NCT02222922|183272025|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|77.23||||0.2316|TWO_SIDED|90.0|53.8|110.87|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||110.87|53.80|0.2316
91689234|NCT02222922|183272026|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.97||||0.4264|TWO_SIDED|90.0|60.05|120.22|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||120.22|60.05|0.4264
91689235|NCT02222922|183272027|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.32||||0.5123|TWO_SIDED|90.0|64.03|121.82|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||121.82|64.03|0.5123
91721362|NCT02966834|183335300|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|95.0|-1.8|5.1|||||Fatigue|||5.1|-1.8|
91488580|NCT01419626|182849511|SUPERIORITY||Difference in LS mean|-0.15|||<|0.001|TWO_SIDED|95.0|-0.18|-0.12|||ANCOVA|||Statistical analysis at Week 4||-0.120|-0.180|<0.001
91488581|NCT01419626|182849511|SUPERIORITY||Difference in LS mean|-0.257|||<|0.001|TWO_SIDED|95.0|-0.287|-0.226|||ANCOVA|||Statistical analysis at Week 4||-0.226|-0.287|<0.001
91488582|NCT01419626|182849511|SUPERIORITY||Difference in LS mean|-0.107|||<|0.001|TWO_SIDED|95.0|-0.137|-0.077|||ANCOVA|||Statistical analysis at Week 4||-0.077|-0.137|<0.001
91488583|NCT01419626|182849512|SUPERIORITY||Difference in LS mean|-0.362|||<|0.001|TWO_SIDED|95.0|-0.465|-0.259|||ANCOVA|||Statistical analysis at Week 2||-0.259|-0.465|<0.001
91488584|NCT01419626|182849512|SUPERIORITY||Difference in LS mean|-0.534|||<|0.001|TWO_SIDED|95.0|-0.637|-0.431|||ANCOVA|||Statistical analysis at Week 2||-0.431|-0.637|<0.001
91689236|NCT02222922|183272028|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.15||||0.824|TWO_SIDED|90.0|44.79|185.5|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.50|44.79|0.8240
91689237|NCT02222922|183272029|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|89.58||||0.7922|TWO_SIDED|90.0|43.94|182.62|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||182.62|43.94|0.7922
91689238|NCT02222922|183272030|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.17||||0.824|TWO_SIDED|90.0|44.87|185.25|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.25|44.87|0.8240
91689239|NCT02222922|183272031|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|102.31||||0.9553|TWO_SIDED|90.0|51.08|204.9|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||204.90|51.08|0.9553
91689240|NCT02222922|183272032|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|81.14||||0.2951|TWO_SIDED|90.0|57.99|113.54|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||113.54|57.99|0.2951
91689241|NCT02222922|183272033|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.02||||0.3769|TWO_SIDED|90.0|60.24|117.19|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||117.19|60.24|0.3769
91689242|NCT02222922|183272034|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|86.15||||0.4385|TWO_SIDED|90.0|62.2|119.32|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||119.32|62.20|0.4385
91689243|NCT02222922|183272035|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.75||||0.5678|TWO_SIDED|90.0|62.24|126.56|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||126.56|62.24|0.5678
91689244|NCT02002221|183272065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.08|-0.73|||ANCOVA|||H0: δ vildagliptin 50 mg bid = δ placebo versus H1: δ Vildagliptin 50 mg bid \< δ placebo,||-0.73|-1.08|< 0.001
91689245|NCT03743051|183272088|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.345|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.718|1.971|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MW; H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.971|0.718|<0.0001
91689246|NCT03743051|183272089|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.622|STANDARD_ERROR_OF_MEAN|0.434||0.1514|TWO_SIDED|95.0|-0.228|1.472|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||1.472|-0.228|0.1514
91689247|NCT03743051|183272090|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.532|<|0.0001|TWO_SIDED|95.0|1.367|3.453|||ANOVA|||||3.453|1.367|<0.0001
91689248|NCT03743051|183272091|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.336|STANDARD_ERROR_OF_MEAN|0.484||0.0057|TWO_SIDED|95.0|0.388|2.284|||ANOVA|||||2.284|0.388|0.0057
91689249|NCT03743051|183272092|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.403||0.0108|TWO_SIDED|95.0|0.238|1.816|||ANOVA|||||1.816|0.238|0.0108
91689250|NCT03743051|183272093|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.535|STANDARD_ERROR_OF_MEAN|0.475||0.2605|TWO_SIDED|95.0|-0.397|1.466|||ANOVA|||||1.466|-0.397|0.2605
91689251|NCT02550561|183272094|SUPERIORITY|||||||0.317||||||Subjects that reported either moderately or markedly improved on the GRA scale at 6 weeks compared to 12 weeks.|McNemar|||||||0.317
91689252|NCT02550561|183272095|OTHER|||||||0.47|||||||paired t-tests|||The mean change in Visual Analog Scale (VAS) score for bladder pain||||0.47
91689253|NCT02550561|183272095|OTHER|||||||0.17|||||||paired t-test|||The mean change in Pelvis Pain and Urgency/Frequency Patient Symptom (PUF) score||||0.17
91689254|NCT02550561|183272095|OTHER|||||||0.08|||||||paired t-test|||The mean change for O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)||||.08
91689255|NCT02550561|183272095|OTHER|||||||0.51|||||||paired t-test|||The mean change O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)||||0.51
91689256|NCT02550561|183272095|OTHER|||||||0.22|||||||paired t-test|||The mean change in 24-h urinary frequency||||0.22
91488585|NCT01419626|182849512|SUPERIORITY||Difference in LS mean|-0.171||||0.001|TWO_SIDED|95.0|-0.273|-0.069|||ANCOVA|||Statistical analysis at Week 2||-0.069|-0.273|0.001
91488586|NCT01419626|182849513|SUPERIORITY||Difference in LS mean|-0.401|||<|0.001|TWO_SIDED|95.0|-0.51|-0.292|||ANCOVA|||Statistical analysis at Week 2||-0.292|-0.510|<0.001
91527118|NCT03445065|182929548|SUPERIORITY||Mean Difference (Net)|-0.2||||0.671|TWO_SIDED|95.0|-1.2|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-1.2|0.671
91689257|NCT00262028|183272125|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A||44|29|
91689258|NCT00262028|183272125|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C||26|12|
91689259|NCT00262028|183272125|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W||29|17|
91689260|NCT00262028|183272125|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y||38|25|
91689261|NCT00262028|183272125|SUPERIORITY_OR_OTHER||Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||44|29|
91689262|NCT00262028|183272125|SUPERIORITY_OR_OTHER||Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||26|12|
91689263|NCT00262028|183272125|SUPERIORITY_OR_OTHER||Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||29|17|
91689264|NCT00262028|183272125|SUPERIORITY_OR_OTHER||Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||38|25|
91689265|NCT01998841|183272169|SUPERIORITY||Difference in Annualized Rate of Change|0.33|STANDARD_ERROR_OF_MEAN|0.41||0.43|TWO_SIDED|95.0|-0.48|1.13|||RCRM|||Analysis was based on random coefficient regression model (RCRM) using unstructured covariance matrix: API Composite Endpoint=Treatment \* Analysis Year + interactive voice or Web-based response system (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein E4 (APOE4) Carrier Status + IxRS defined CDR Global Score.||1.13|-0.48|0.43
91689266|NCT01998841|183272170|SUPERIORITY||Difference in Annualized Rate of Change|0.008|STANDARD_ERROR_OF_MEAN|0.006||0.16|TWO_SIDED|95.0|-0.003|0.02|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FCSRT Cueing Index = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.02|-0.003|0.16
91689267|NCT01998841|183272171|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.48|TWO_SIDED|95.0|0.41|1.52|||Stratified Log Rank||Hazard ratios were estimated by Cox regression|Stratification factors used: Age Group, Education History, APOE4 Carrier Status, Clinical Dementia Rating (CDR) Global Score.||1.52|0.41|0.48
91488587|NCT01419626|182849513|SUPERIORITY||Difference in LS mean|-0.558|||<|0.001|TWO_SIDED|95.0|-0.667|-0.449|||ANCOVA|||Statistical analysis at Week 2||-0.449|-0.667|<0.001
91488588|NCT01419626|182849513|SUPERIORITY||Difference in LS mean|-0.157|||<|0.001|TWO_SIDED|95.0|-0.265|-0.049|||ANCOVA|||Statistical analysis at Week 2||-0.049|-0.265|<0.001
91689268|NCT01998841|183272172|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.76|TWO_SIDED|95.0|0.53|1.59|||Stratified Log Rank||Hazard ratios were estimated by Cox regression.|Stratification factors used: Age Group, Education History, APOE4 Carrier Status.||1.59|0.53|0.76
91689269|NCT01998841|183272173|SUPERIORITY||Difference in Annualized Rate of Change|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.64|TWO_SIDED|95.0|-0.15|0.09|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: CDR-SB = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.09|-0.15|0.64
91721363|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-3.6|3.6|||||Fatigue|||3.6|-3.6|
91721364|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Cognitive|||2.6|-2.5|
91488589|NCT01419626|182849514|SUPERIORITY||Difference in LS mean|-0.03|||<|0.001|TWO_SIDED|95.0|-0.046|-0.014|||ANCOVA|||Statistical analysis at Week 2||-0.014|-0.046|<0.001
91488590|NCT01419626|182849514|SUPERIORITY||Difference in LS mean|-0.039|||<|0.001|TWO_SIDED|95.0|-0.055|-0.023|||ANCOVA|||Statistical analysis at Week 2||-0.023|-0.055|<0.001
91488591|NCT01419626|182849514|SUPERIORITY||Difference in LS mean|-0.009||||0.294|TWO_SIDED|95.0|-0.025|0.007|||ANCOVA|||Statistical analysis at Week 2||0.007|-0.025|0.294
91488592|NCT01419626|182849514|SUPERIORITY||Difference in LS mean|-0.019||||0.02|TWO_SIDED|95.0|-0.035|-0.003|||ANCOVA|||Statistical analysis at Week 4||-0.003|-0.035|0.020
91689270|NCT01998841|183272174|SUPERIORITY||Difference in Annualized Rate of Change|0.18|STANDARD_ERROR_OF_MEAN|0.29||0.55|TWO_SIDED|95.0|-0.4|0.75|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: RBANS Total Score = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.75|-0.40|0.55
91689271|NCT01998841|183272175|SUPERIORITY||Difference in Annualized Rate of Change|-0.0006|STANDARD_ERROR_OF_MEAN|0.002||0.69|TWO_SIDED|95.0|-0.0037|0.0024|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: PET SUVR = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.0024|-0.0037|0.69
91689272|NCT01998841|183272176|SUPERIORITY||Difference in Annualized Rate of Change|0.003|STANDARD_ERROR_OF_MEAN|0.002||0.25|TWO_SIDED|95.0|-0.002|0.007|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FDG-PET = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.007|-0.002|0.25
91689273|NCT01998841|183272177|SUPERIORITY||Difference in Annualized Rate of Change|107.78|STANDARD_ERROR_OF_MEAN|92.28||0.25|TWO_SIDED|95.0|-74.5|290.05|||RCRM|||Whole Brain: Analysis was based on RCRM using unstructured covariance matrix: MRI Whole Brain (Derived) = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||290.05|-74.5|0.25
91689274|NCT01998841|183272177|SUPERIORITY||Difference in Annualized Rate of Change|9.6|STANDARD_ERROR_OF_MEAN|17.39||0.58|TWO_SIDED|95.0|-24.74|43.94|||RCRM|||Bilateral Hippocampus: Analysis was based on RCRM using unstructured covariance matrix: MRI Bilateral Hippocampus = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||43.94|-24.74|0.58
91689275|NCT01998841|183272177|SUPERIORITY||Difference in Annualized Rate of Change|19.92|STANDARD_ERROR_OF_MEAN|213.08||0.93|TWO_SIDED|95.0|-400.78|440.62|||RCRM|||Ventricles: Analysis was based on RCRM using unstructured covariance matrix: MRI Ventricles = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||440.62|-400.78|0.93
91689276|NCT01998841|183272178|SUPERIORITY||Difference in Annualized Rate of Change|-1.97|STANDARD_ERROR_OF_MEAN|3.09||0.53|TWO_SIDED|95.0|-8.17|4.23|||RCRM|||tTau: Analysis was based on RCRM using unstructured covariance matrix: CSF tTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||4.23|-8.17|0.53
91689277|NCT01998841|183272178|SUPERIORITY||Difference in Annualized Rate of Change|-0.5|STANDARD_ERROR_OF_MEAN|0.46||0.28|TWO_SIDED|95.0|-1.43|0.43|||RCRM|||pTau: Analysis was based on RCRM using unstructured covariance matrix: CSF pTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.43|-1.43|0.28
91689278|NCT01998841|183272186|SUPERIORITY||Difference in Annualized Rate of Change|7522.55|STANDARD_ERROR_OF_MEAN|313.17|<|0.0001|TWO_SIDED|95.0|6903.44|8141.65|||RCRM|||Aβ1-40: Analysis was based on RCRM using unstructured covariance matrix: APlasma Amyloid Beta 1-40 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||8141.65|6903.44|<0.0001
91689279|NCT01998841|183272186|SUPERIORITY||Difference in Annualized Rate of Change|556.03|STANDARD_ERROR_OF_MEAN|23.98|<|0.0001|TWO_SIDED|95.0|508.63|603.44|||RCRM|||Aβ1-42: Analysis was based on RCRM using unstructured covariance matrix: Plasma Amyloid Peptid Beta 42 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||603.44|508.63|<0.0001
91689280|NCT00972595|183272191|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.98||||||90.0|0.93|1.03||||||Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.03|0.93|
91689281|NCT00972595|183272192|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.99||||||90.0|0.93|1.05||||||"Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally"||1.05|0.93|
91689282|NCT00141778|183272205|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||Discrete variables were compared among treatment groups with a chi-square test.||||0.95
91689283|NCT00141778|183272206|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
91689284|NCT00141778|183272207|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
91689285|NCT00141778|183272208|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
91689286|NCT00141778|183272209|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Kruskal-Wallis|||||||0.56
91689287|NCT00141778|183272210|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||||||0.15
91689288|NCT00141778|183272211|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Chi-squared|||||||0.38
91488593|NCT01419626|182849514|SUPERIORITY||Difference in LS mean|-0.034|||<|0.001|TWO_SIDED|95.0|-0.05|-0.018|||ANCOVA|||Statistical analysis at Week 4||-0.018|-0.050|<0.001
91488594|NCT01419626|182849514|SUPERIORITY||Difference in LS mean|-0.015||||0.071|TWO_SIDED|95.0|-0.031|0.001|||ANCOVA|||Statistical analysis at Week 4||0.001|-0.031|0.071
91488595|NCT01419626|182849515|SUPERIORITY||Difference in LS mean|-0.067|||<|0.001||95.0|-0.083|-0.05|||ANCOVA|||Statistical analysis at Week 2||-0.050|-0.083|<0.001
91488596|NCT01419626|182849515|SUPERIORITY||Difference in LS mean|-0.083|||<|0.001|TWO_SIDED|95.0|-0.099|-0.066|||ANCOVA|||Statistical analysis at Week 2||-0.066|-0.099|<0.001
91488597|NCT01419626|182849515|SUPERIORITY||Difference in LS mean|-0.016||||0.057|TWO_SIDED|95.0|-0.032|0.0|||ANCOVA|||Statistical analysis at Week 2||0.000|-0.032|0.057
91689289|NCT00141778|183272212|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
91689290|NCT02085447|183272216|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|||||||.012
91689291|NCT02085447|183272217|SUPERIORITY|||||||0.028|||||||t-test, 1 sided|||||||.028
91689292|NCT02085447|183272218|SUPERIORITY|||||||0.162|||||||t-test, 1 sided|||||||.162
91689293|NCT02085447|183272219|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||||||.021
91689294|NCT02085447|183272220|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||.005
91689295|NCT02085447|183272221|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91721365|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7|||||Cognitive|||1.7|-2.9|
91721366|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.1|2.5|||||Cognitive|||2.5|-2.1|
91721367|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.8|2.8|||||Cognitive|||2.8|-1.8|
91721368|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.2|2.5|||||Cognitive|||2.5|-2.2|
91721369|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.1|0.4|||||Emotional|||0.4|-2.1|
91488598|NCT01419626|182849515|SUPERIORITY||Difference in LS mean|-0.077|||<|0.001|TWO_SIDED|95.0|-0.095|-0.059|||ANCOVA|||Statistical analysis at Week 4||-0.059|-0.095|<0.001
91689296|NCT02085447|183272222|SUPERIORITY|||||||0.197|||||||t-test, 1 sided|||||||.197
91689297|NCT02085447|183272223|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91689298|NCT02085447|183272224|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91689299|NCT02085447|183272225|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91689300|NCT02085447|183272226|SUPERIORITY|||||||0.053|||||||t-test, 1 sided|||||||.053
91689301|NCT02085447|183272227|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91689302|NCT02085447|183272228|SUPERIORITY|||||||0.821|||||||t-test, 1 sided|||||||.821
91721370|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.9|1.3|||||Emotional|||1.3|-0.9|
91721371|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
91721372|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-1.9|0.3|||||Emotional|||0.3|-1.9|
91721373|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
91721374|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-2.4|3.0|||||Social|||3.0|-2.4|
91721375|NCT02966834|183335300|OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-1.3|3.7|||||Social|||3.7|-1.3|
91721376|NCT02966834|183335300|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.3|2.7|||||Social|||2.7|-2.3|
91721377|NCT02966834|183335300|OTHER||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-4.8|0.1|||||Social|||0.1|-4.8|
91488599|NCT01419626|182849515|SUPERIORITY||Difference in LS mean|-0.101|||<|0.001|TWO_SIDED|95.0|-0.12|-0.083|||ANCOVA|||Statistical analysis at Week 4||-0.083|-0.120|<0.001
91488600|NCT01419626|182849515|SUPERIORITY||Difference in LS mean|-0.024||||0.009|TWO_SIDED|95.0|-0.042|-0.006|||ANCOVA|||Statistical analysis at Week 4||-0.006|-0.042|0.009
91689303|NCT02085447|183272229|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
91689304|NCT02085447|183272230|SUPERIORITY|||||||0.425|||||||t-test, 1 sided|||||||.425
91689305|NCT02085447|183272231|SUPERIORITY|||||||0.577|||||||t-test, 1 sided|||||||.577
91689306|NCT02085447|183272232|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
91689307|NCT02085447|183272233|SUPERIORITY|||||||0.706|||||||t-test, 1 sided|||||||.706
91689308|NCT02085447|183272234|SUPERIORITY|||||||0.481|||||||t-test, 1 sided|||||||.481
91689309|NCT02085447|183272235|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.020
91689310|NCT02085447|183272236|SUPERIORITY|||||||0.103|||||||t-test, 1 sided|||||||.103
91689311|NCT02085447|183272237|SUPERIORITY|||||||0.063|||||||t-test, 1 sided|||||||.063
91721378|NCT02966834|183335300|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-2.8|2.4|||||Social|||2.4|-2.8|
91721379|NCT02966834|183335301|OTHER||Mean Difference (Net)|-106.8|||||TWO_SIDED|95.0|-251.7|38.2||||||||38.2|-251.7|
91721380|NCT02966834|183335301|OTHER||Mean Difference (Net)|-87.4|||||TWO_SIDED|95.0|-198.5|23.8||||||||23.8|-198.5|
91721381|NCT02966834|183335301|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-125.6|126.5||||||||126.5|-125.6|
91721382|NCT02966834|183335301|OTHER||Mean Difference (Net)|-78.3|||||TWO_SIDED|95.0|-211.5|54.8||||||||54.8|-211.5|
91721383|NCT02966834|183335301|OTHER||Mean Difference (Net)|-30.0|||||TWO_SIDED|95.0|-170.7|110.7||||||||110.7|-170.7|
91721384|NCT02966834|183335303|OTHER||Mean Difference (Net)|-21.4|||||TWO_SIDED|95.0|-58.4|15.5||||||||15.5|-58.4|
91721385|NCT02966834|183335303|OTHER||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-41.9|16.4||||||||16.4|-41.9|
91721386|NCT02966834|183335303|OTHER||Mean Difference (Net)|-15.0|||||TWO_SIDED|95.0|-49.9|20.0||||||||20.0|-49.9|
91721387|NCT02966834|183335303|OTHER||Mean Difference (Net)|-26.5|||||TWO_SIDED|95.0|-63.3|10.4||||||||10.4|-63.3|
91721388|NCT02966834|183335303|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-36.7|37.1||||||||37.1|-36.7|
91721389|NCT02966834|183335304|OTHER||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-52.73|12.74||||||||12.74|-52.73|
91721390|NCT02966834|183335304|OTHER||Mean Difference (Net)|-24.7|||||TWO_SIDED|95.0|-50.8|1.39||||||||1.39|-50.80|
91721391|NCT02966834|183335304|OTHER||Mean Difference (Net)|-22.61|||||TWO_SIDED|95.0|-53.39|8.16||||||||8.16|-53.39|
91721392|NCT02966834|183335304|OTHER||Mean Difference (Net)|-31.67|||||TWO_SIDED|95.0|-63.44|0.09||||||||0.09|-63.44|
91721393|NCT02966834|183335304|OTHER||Mean Difference (Net)|-5.79|||||TWO_SIDED|95.0|-38.33|26.74||||||||26.74|-38.33|
91721394|NCT02966834|183335305|OTHER||Mean Difference (Net)|-106.0|||||TWO_SIDED|95.0|-205.1|-6.8||||||||-6.8|-205.1|
91721395|NCT02966834|183335305|OTHER||Mean Difference (Net)|-65.5|||||TWO_SIDED|95.0|-148.5|17.6||||||||17.6|-148.5|
91721396|NCT02966834|183335305|OTHER||Mean Difference (Net)|-42.8|||||TWO_SIDED|95.0|-136.5|50.9||||||||50.9|-136.5|
91721397|NCT02966834|183335305|OTHER||Mean Difference (Net)|-65.8|||||TWO_SIDED|95.0|-161.2|29.5||||||||29.5|-161.2|
91721398|NCT02966834|183335305|OTHER||Mean Difference (Net)|-54.1|||||TWO_SIDED|95.0|-153.6|45.3||||||||45.3|-153.6|
91721399|NCT02966834|183335306|OTHER||Mean Difference (Net)|-6.099|||||TWO_SIDED|95.0|-11.929|-0.268||||||||-0.268|-11.929|
91721400|NCT02966834|183335306|OTHER||Mean Difference (Net)|-2.337|||||TWO_SIDED|95.0|-6.962|2.289||||||||2.289|-6.962|
91721401|NCT02966834|183335306|OTHER||Mean Difference (Net)|-2.232|||||TWO_SIDED|95.0|-7.679|3.215||||||||3.215|-7.679|
91689312|NCT04052620|183272241|NON_INFERIORITY|Non-inferiority criteria: if the upper 95% Confidence Interval (CI) of Least Square (LS) mean difference was less than 13 mm then DDEA 2.32% gel BID was concluded as non-inferior.|Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|2.09||0.595|TWO_SIDED|95.0|-3.0|5.22|||ANCOVA|||||5.22|-3.00|0.5950
91689313|NCT04052620|183272243|OTHER||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.12||0.2536|TWO_SIDED|95.0|-6.61|1.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||1.75|-6.61|0.2536
91689314|NCT04052620|183272243|OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|1.76||0.6643|TWO_SIDED|95.0|-4.23|2.7|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||2.70|-4.23|0.6643
91689315|NCT04052620|183272244|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.19||0.3118|TWO_SIDED|95.0|-1.13|3.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.54|-1.13|0.3118
91689316|NCT04052620|183272244|OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|1.35||0.4937|TWO_SIDED|95.0|-3.6|1.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.74|-3.60|0.4937
91689317|NCT04052620|183272244|OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.67||0.3825|TWO_SIDED|95.0|-1.83|4.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.74|-1.83|0.3825
91689318|NCT04052620|183272245|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.26||0.836|TWO_SIDED|95.0|-2.23|2.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||2.75|-2.23|0.8360
91689319|NCT04052620|183272245|OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.24||0.3119|TWO_SIDED|95.0|-3.69|1.18|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.18|-3.69|0.3119
91689320|NCT04052620|183272245|OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.45||0.2535|TWO_SIDED|95.0|-1.2|4.52|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.52|-1.20|0.2535
91689321|NCT04052620|183272246|OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.51||0.6242|TWO_SIDED|95.0|-2.23|3.71|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.71|-2.23|0.6242
91689322|NCT04052620|183272246|OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|2.06||0.8905|TWO_SIDED|95.0|-4.33|3.77|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.77|-4.33|0.8905
91689323|NCT04052620|183272246|OTHER||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|2.24||0.3439|TWO_SIDED|95.0|-2.29|6.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||6.54|-2.29|0.3439
91689324|NCT04052620|183272247|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1554|TWO_SIDED|95.0|-0.44|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.44|0.1554
91689325|NCT04052620|183272247|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0047|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||-0.12|-0.66|0.0047
91689326|NCT04052620|183272247|OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.10|-0.66|0.0082
91689327|NCT04052620|183272248|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2182|TWO_SIDED|95.0|-0.3|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.30|0.2182
91689328|NCT04052620|183272248|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0574|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.01|-0.36|0.0574
91689329|NCT04052620|183272248|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0194|TWO_SIDED|95.0|-0.37|-0.03|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.03|-0.37|0.0194
91689330|NCT04052620|183272249|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.821||0.6545|TWO_SIDED|95.0|-1.25|1.986|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.986|-1.250|0.6545
91689331|NCT04052620|183272249|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.721||0.4924|TWO_SIDED|95.0|-1.915|0.924|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.924|-1.915|0.4924
91689332|NCT04052620|183272250|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.823||0.9491|TWO_SIDED|95.0|-1.675|1.57|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.570|-1.675|0.9491
91689333|NCT04052620|183272250|OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.451||0.582|TWO_SIDED|95.0|-2.059|3.659|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.659|-2.059|0.5820
91689334|NCT01112059|183272263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.05|TWO_SIDED|95.0|0.128|0.633|||Wilcoxon (Mann-Whitney)|||||0.633|0.128|<0.05
91689335|NCT03093259|183272298|OTHER|One-sided 10% significance level||||||0.2096|||||||Chi-squared|||||||0.2096
91689336|NCT03093259|183272299|OTHER|||||||0.1588|||||||Chi-squared|||||||0.1588
91689337|NCT03093259|183272300|OTHER|||||||0.483|||||||ANCOVA|||||||0.4830
91689338|NCT03093259|183272301|OTHER|||||||0.0742|||||||ANCOVA|||||||0.0742
91689339|NCT03093259|183272302|OTHER|||||||0.0462|||||||ANCOVA|||||||0.0462
91689340|NCT00550459|183272308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.55||0.08|TWO_SIDED|95.0|-0.03|0.5||Secondary endpoints were ordered in 5 tiers to be analyzed only when \>=1 of the endpoints in the prior tier were significant. Since primary endpoint not stat significant, analyses of secondary endpoint tiers presented for exploratory purposes only|ANCOVA|ANCOVA with factors of treatment, disease severity, age(6 Degrees of Freedom), and covariate baseline to fit primary endpoint using the ITT dataset.||Analysis of covariance (ANCOVA) with factors of treatment,disease severity (\<130mEq/L \[mmol/L\] or ≥130mEq/L \[mmol/L\] at baseline),age (\<65, ≥65 to \<75,and ≥75 years) (factor with 6 Degrees of Freedom), and covariate baseline used to fit primary endpoint using the intent-to-treat (ITT) dataset. Estimated treatment effect and its 95% confidence interval (CI) provided under the model with p-value. A 2-sided alpha (0.05) applied to the primary analysis. Primary analysis based on observed cases (OC).||0.50|-0.03|0.08
91689341|NCT00550459|183272309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.63||0.21|TWO_SIDED|95.0|-0.12|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|-0.12|0.21
91721402|NCT02966834|183335306|OTHER||Mean Difference (Net)|-1.492|||||TWO_SIDED|95.0|-7.413|4.43||||||||4.430|-7.413|
91721403|NCT02966834|183335306|OTHER||Mean Difference (Net)|5.236|||||TWO_SIDED|95.0|-0.591|11.063||||||||11.063|-0.591|
91721404|NCT02966834|183335307|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.7|1.6||||||||1.6|-2.7|
91721405|NCT02966834|183335307|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.5|2.1||||||||2.1|-1.5|
91721406|NCT02966834|183335307|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.2|2.7||||||||2.7|-1.2|
91721407|NCT02966834|183335307|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.1|2.0||||||||2.0|-2.1|
91721408|NCT02966834|183335307|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.5|2.9||||||||2.9|-1.5|
91721409|NCT02966834|183335308|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04||||||||0.04|-0.08|
91488601|NCT03569033|182849518|OTHER||Difference in Least Squares Means|-0.32||||0.748|TWO_SIDED|95.0|-2.29|1.66|||Longitudinal Data Analysis|||||1.66|-2.29|0.748
91689342|NCT00550459|183272310|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.27|STANDARD_DEVIATION|0.41||0.02|TWO_SIDED|95.0|0.04|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|0.04|0.02
91721410|NCT02966834|183335308|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.09|0.01||||||||0.01|-0.09|
91721411|NCT02966834|183335308|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.06|0.05||||||||0.05|-0.06|
91721412|NCT02966834|183335308|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
91721413|NCT02966834|183335308|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.1|0.02||||||||0.02|-0.10|
91721414|NCT02966834|183335309|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.33|0.63||||||||0.63|-0.33|
91721415|NCT02966834|183335309|OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.51|0.3||||||||0.30|-0.51|
91721416|NCT02966834|183335309|OTHER||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.34|0.58||||||||0.58|-0.34|
91721417|NCT02966834|183335309|OTHER||Mean Difference (Net)|-0.08|||||TWO_SIDED|95.0|-0.54|0.38||||||||0.38|-0.54|
91721418|NCT02966834|183335309|OTHER||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.54|0.41||||||||0.41|-0.54|
91721419|NCT02966834|183335319|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.69|12.02|||||Analysis was performed using Logistic regression. No covariates were used.|||12.02|0.69|
91721420|NCT02966834|183335319|OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.48|5.02|||||Analysis was performed using Logistic regression. No covariates were used.|||5.02|0.48|
91721421|NCT02966834|183335319|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
91721422|NCT02966834|183335319|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
91721423|NCT02966834|183335319|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.43|4.13|||||Analysis was performed using Logistic regression. No covariates were used.|||4.13|0.43|
91721424|NCT02966834|183335320|OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.41|4.47|||||Analysis was performed using Logistic regression. No covariates were used.|||4.47|0.41|
91721425|NCT02966834|183335320|OTHER||Odds Ratio (OR)|3.18|||||TWO_SIDED|95.0|0.95|10.65|||||Analysis was performed using Logistic regression. No covariates were used.|||10.65|0.95|
91721426|NCT02966834|183335320|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.62|5.53|||||Analysis was performed using Logistic regression. No covariates were used.|||5.53|0.62|
91721427|NCT02966834|183335320|OTHER||Odds Ratio (OR)|2.27|||||TWO_SIDED|95.0|0.74|6.92|||||Analysis was performed using Logistic regression. No covariates were used.|||6.92|0.74|
91721428|NCT02966834|183335320|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|0.69|6.51|||||Analysis was performed using Logistic regression. No covariates were used.|||6.51|0.69|
91721429|NCT02966834|183335321|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.27|3.04|||||Analysis was performed using Logistic regression. No covariates were used.|||3.04|0.27|
91721430|NCT02966834|183335321|OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|0.73|6.91|||||Analysis was performed using Logistic regression. No covariates were used.|||6.91|0.73|
91721431|NCT02966834|183335321|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.35|3.08|||||Analysis was performed using Logistic regression. No covariates were used.|||3.08|0.35|
91721432|NCT02966834|183335321|OTHER||Odds Ratio (OR)|2.17|||||TWO_SIDED|95.0|0.73|6.42|||||Analysis was performed using Logistic regression. No covariates were used.|||6.42|0.73|
91721433|NCT02966834|183335321|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.67|5.99|||||Analysis was performed using Logistic regression. No covariates were used.|||5.99|0.67|
91721434|NCT02966834|183335322|OTHER||Mean Difference (Net)|18.21|||||TWO_SIDED|95.0|-2.59|39.0||||||||39.00|-2.59|
91488602|NCT03569033|182849519|OTHER||Difference in Least Squares Means|0.99||||0.754|TWO_SIDED|95.0|-5.33|7.3|||ANCOVA|||||7.30|-5.33|0.754
91488603|NCT03569033|182849520|OTHER||Difference in Least Squares Means|0.8||||0.627|TWO_SIDED|95.0|-2.5|4.1|||ANCOVA|||||4.10|-2.50|0.627
91488604|NCT03569033|182849521|OTHER||Difference in Least Squares Means|0.09||||0.631|TWO_SIDED|95.0|-0.28|0.45|||ANCOVA|||||0.45|-0.28|0.631
91721435|NCT02966834|183335322|OTHER||Mean Difference (Net)|11.05|||||TWO_SIDED|95.0|-7.42|29.53||||||||29.53|-7.42|
91721436|NCT02966834|183335322|OTHER||Mean Difference (Net)|18.44|||||TWO_SIDED|95.0|0.82|36.06||||||||36.06|0.82|
91721437|NCT02966834|183335322|OTHER||Mean Difference (Net)|25.48|||||TWO_SIDED|95.0|7.0|43.95||||||||43.95|7.00|
91721438|NCT02966834|183335322|OTHER||Mean Difference (Net)|13.26|||||TWO_SIDED|95.0|-5.47|31.99||||||||31.99|-5.47|
91721439|NCT02966834|183335323|OTHER||Mean Difference (Net)|14.99|||||TWO_SIDED|95.0|-5.13|35.1||||||||35.10|-5.13|
91721440|NCT02966834|183335323|OTHER||Mean Difference (Net)|6.97|||||TWO_SIDED|95.0|-10.9|24.84||||||||24.84|-10.90|
91721441|NCT02966834|183335323|OTHER||Mean Difference (Net)|11.78|||||TWO_SIDED|95.0|-5.27|28.82||||||||28.82|-5.27|
91721442|NCT02966834|183335323|OTHER||Mean Difference (Net)|21.83|||||TWO_SIDED|95.0|3.96|39.7||||||||39.70|3.96|
91721443|NCT02966834|183335323|OTHER||Mean Difference (Net)|21.58|||||TWO_SIDED|95.0|3.46|39.69||||||||39.69|3.46|
91721444|NCT02966834|183335324|OTHER||Mean Difference (Net)|6.15|||||TWO_SIDED|95.0|-14.76|27.06||||||||27.06|-14.76|
91721445|NCT02966834|183335324|OTHER||Mean Difference (Net)|7.26|||||TWO_SIDED|95.0|-11.32|25.84||||||||25.84|-11.32|
91721446|NCT02966834|183335324|OTHER||Mean Difference (Net)|9.13|||||TWO_SIDED|95.0|-8.59|26.85||||||||26.85|-8.59|
91721447|NCT02966834|183335324|OTHER||Mean Difference (Net)|19.94|||||TWO_SIDED|95.0|1.36|38.51||||||||38.51|1.36|
91721448|NCT02966834|183335324|OTHER||Mean Difference (Net)|27.04|||||TWO_SIDED|95.0|8.2|45.87||||||||45.87|8.20|
91721449|NCT02966834|183335325|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-1.46|0.92||||||||0.92|-1.46|
91721450|NCT02966834|183335325|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-1.58|0.62||||||||0.62|-1.58|
91721451|NCT02966834|183335325|OTHER||Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-1.53|0.61||||||||0.61|-1.53|
91721452|NCT02966834|183335325|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|95.0|-2.03|0.12||||||||0.12|-2.03|
91721453|NCT02966834|183335325|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.4|0.8||||||||0.80|-1.40|
91721454|NCT02966834|183335326|OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-1.49|0.71||||||||0.71|-1.49|
91721455|NCT02966834|183335326|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.41|0.61||||||||0.61|-1.41|
91721456|NCT02966834|183335326|OTHER||Mean Difference (Net)|-0.26|||||TWO_SIDED|95.0|-1.24|0.72||||||||0.72|-1.24|
91721457|NCT02966834|183335326|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.39|0.56||||||||0.56|-1.39|
91721458|NCT02966834|183335326|OTHER||Mean Difference (Net)|-0.29|||||TWO_SIDED|95.0|-1.28|0.7||||||||0.70|-1.28|
91721459|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.7|0.5|||||Duration|||0.5|-0.7|
91721460|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.2|0.9|||||Duration|||0.9|-0.2|
91721461|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.1|||||Duration|||0.1|-1.0|
91721462|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||||Duration|||0.7|-0.3|
91721463|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.4|0.6|||||Duration|||0.6|-0.4|
91488605|NCT03452228|182849551|SUPERIORITY||Median Difference (Final Values)|-43.5|||||TWO_SIDED|95.0|-89.4|1238.9||||||||1238.9|-89.4|
91488606|NCT03452228|182849551|SUPERIORITY||Median Difference (Final Values)|-75.5|||||TWO_SIDED|95.0|-82.2|121.2||||||||121.2|-82.2|
91721464|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.3|||||Degree|||0.3|-0.8|
91721465|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Degree|||0.5|-0.5|
91721466|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.5|||||Degree|||0.5|-0.6|
91721467|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Degree|||0.3|-0.7|
91721468|NCT02966834|183335327|OTHER||Median Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||||Degree|||0.4|-0.6|
91721469|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Direction|||0.7|-0.7|
91721470|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||||Direction|||0.6|-0.7|
91721471|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Direction|||0.5|-0.8|
91721472|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2|||||Direction|||0.2|-1.0|
91721473|NCT02966834|183335327|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Direction|||0.6|-0.6|
91721474|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.1|0.3|||||Disability|||0.3|-1.1|
91721475|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Disability|||0.5|-0.8|
91721476|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
91721477|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
91721478|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
91721479|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.3|||||Distribution|||0.3|-0.9|
91721480|NCT02966834|183335327|OTHER||Median Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
91721481|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||||Distribution|||0.0|-1.0|
91721482|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
91721483|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Distribution|||0.3|-0.7|
91721484|NCT02966834|183335327|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||5-D Itch Total Score|||1.3|-3.3|
91721485|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||5-D Itch Total Score|||2.1|-2.2|
91721486|NCT02966834|183335327|OTHER||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.5|0.7|||||5-D Itch Total Score|||0.7|-3.5|
91721487|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-3.0|1.2|||||5-D Itch Total Score|||1.2|-3.0|
91721488|NCT02966834|183335327|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||||5-D Itch Total Score|||1.6|-2.7|
91721489|NCT02966834|183335331|OTHER||Mean Difference (Net)|-0.71|||||TWO_SIDED|95.0|-1.69|0.28||||||||0.28|-1.69|
91721490|NCT02966834|183335331|OTHER||Mean Difference (Net)|-0.62|||||TWO_SIDED|95.0|-1.49|0.26||||||||0.26|-1.49|
91721491|NCT02966834|183335331|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-1.76|-0.03||||||||-0.03|-1.76|
91721492|NCT02966834|183335331|OTHER||Mean Difference (Net)|-1.16|||||TWO_SIDED|95.0|-2.05|-0.28||||||||-0.28|-2.05|
91721493|NCT02966834|183335331|OTHER||Mean Difference (Net)|-0.95|||||TWO_SIDED|95.0|-1.85|-0.06||||||||-0.06|-1.85|
91721494|NCT02966834|183335332|OTHER||Least Square (LS) mean ratio|0.967|||||TWO_SIDED|95.0|0.635|1.471||||||||1.471|0.635|
91721495|NCT02966834|183335332|OTHER||LS mean ratio|1.17|||||TWO_SIDED|95.0|0.8|1.712||||||||1.712|0.8|
91721496|NCT02966834|183335332|OTHER||LS mean ratio|0.909|||||TWO_SIDED|95.0|0.627|1.316||||||||1.316|0.627|
91721497|NCT02966834|183335332|OTHER||LS mean ratio|0.69|||||TWO_SIDED|95.0|0.474|1.005||||||||1.005|0.474|
91721498|NCT02966834|183335332|OTHER||LS mean ratio|0.825|||||TWO_SIDED|95.0|0.564|1.207||||||||1.207|0.564|
91721499|NCT02966834|183335333|OTHER||LS mean ratio|1.363|||||TWO_SIDED|95.0|0.932|1.995||||||||1.995|0.932|
91689343|NCT00550459|183272311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.83||0.21|TWO_SIDED|95.0|-0.15|0.67||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.67|-0.15|0.21
91488607|NCT01011738|182849617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.349||||0.0022|TWO_SIDED|95.0|1.542|7.271||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||7.271|1.542|0.0022
91689344|NCT00550459|183272312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.39||0.16|TWO_SIDED|95.0|-0.05|0.3||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.30|-0.05|0.16
91689345|NCT00550459|183272313|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.51|STANDARD_DEVIATION|3.53||0.23|TWO_SIDED|95.0|-4.02|1.0||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||1.00|-4.02|0.23
91689346|NCT00550459|183272314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_DEVIATION|3.51||0.18|TWO_SIDED|95.0|-2.04|0.38||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.38|-2.04|0.18
91689347|NCT00550459|183272315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|STANDARD_DEVIATION|3.45|<|0.0001|TWO_SIDED|95.0|2.89|6.6||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||6.60|2.89|<0.0001
91689348|NCT01459783|183272365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.76|TWO_SIDED|95.0|-5.13|6.95||We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||6.95|-5.13|0.76
91689349|NCT01459783|183272366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.49|TWO_SIDED|95.0|-1.74|3.55||We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||3.55|-1.74|0.49
91689350|NCT04199104|183272400|SUPERIORITY||point estimate|19.3||||1.9e-06|TWO_SIDED|95.0|11.2|27.3|||Miettinen and Nurminen method|||||27.3|11.2|0.0000019
91689351|NCT04199104|183272401|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0001129|TWO_SIDED|95.0|0.55|0.83|||Regression, Cox|||||0.83|0.55|0.0001129
91689352|NCT04199104|183272402|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.8819584|TWO_SIDED|95.0|0.91|1.45|||Regression, Cox|||||1.45|0.91|0.8819584
91689353|NCT00070564|183272413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.32||||0.022|TWO_SIDED|95.0|1.04|1.68|||Log Rank|||||1.68|1.04|0.022
91721500|NCT02966834|183335333|OTHER||LS mean ratio|2.05|||||TWO_SIDED|95.0|1.456|2.887||||||||2.887|1.456|
91689354|NCT00070564|183272413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.072|TWO_SIDED|95.0|0.98|1.59|||Log Rank|||||1.59|0.98|0.072
91689355|NCT00070564|183272413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.38|TWO_SIDED|95.0|0.87|1.44|||Log Rank|||||1.44|0.87|0.38
91689356|NCT00070564|183272413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Log Rank|||||||0.11
91689357|NCT00070564|183272413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.733|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||||1.41|0.61|0.733
91689358|NCT00070564|183272414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.013|TWO_SIDED|95.0|1.08|1.93|||Log Rank|||||1.93|1.08|0.013
91689359|NCT00070564|183272414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.011|TWO_SIDED|95.0|1.09|1.95|||Log Rank|||||1.95|1.09|0.011
91689360|NCT00070564|183272414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.17|TWO_SIDED|95.0|0.91|1.68|||Log Rank|||||1.68|0.91|0.17
91689361|NCT00070564|183272414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.040
91689362|NCT00070564|183272414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.724|TWO_SIDED|95.0|0.54|1.53|||Log Rank|||||1.53|0.54|0.724
91689363|NCT00070564|183272416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||Log Rank|||Overall treatment differences.||||0.67
91689364|NCT00070564|183272416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.42
91689365|NCT00070564|183272417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Log Rank|||Test of overall treatment differences.||||0.90
91689366|NCT00070564|183272417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.52
91721501|NCT02966834|183335333|OTHER||LS mean ratio|2.457|||||TWO_SIDED|95.0|1.758|3.436||||||||3.436|1.758|
91689367|NCT00070564|183272418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|||||||Log Rank|||Test of overall treatment differences.||||0.076
91689368|NCT00070564|183272418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.018
91689369|NCT00070564|183272419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Log Rank|||Test of overall treatment differences.||||0.062
91689370|NCT00070564|183272419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.010
91689371|NCT00070564|183272420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|||Test of overall treatment differences.||||0.69
91689372|NCT00070564|183272420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Log Rank|||Test of interaction two treatments: AC and paclitaxel.||||0.66
91689373|NCT00070564|183272421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||Test of overall treatment differences||||0.40
91689374|NCT00070564|183272421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.28
91689375|NCT05201794|183272531|SUPERIORITY||Odds Ratio (OR)|67.3|||=|0.1409|ONE_SIDED|80.0|15.2|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for proof-of-concept (PoC) when the planned interim analysis would have been performed.|||15.2|=0.1409
91689376|NCT05201794|183272531|SUPERIORITY||Odds Ratio (OR)|67.2|||=|0.1418|ONE_SIDED|80.0|14.9|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||14.9|=0.1418
91689377|NCT05201794|183272532|SUPERIORITY||Odds Ratio (OR)|87.8|||=|0.0192|ONE_SIDED|80.0|58.1|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||58.1|=0.0192
91689378|NCT05201794|183272532|SUPERIORITY||Odds Ratio (OR)|62.9|||=|0.1131|ONE_SIDED|80.0|20.0|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||20|=0.1131
91689379|NCT05201794|183272533|SUPERIORITY||Odds Ratio (OR)|85.4|||=|0.0302|ONE_SIDED|80.0|62.6|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||62.6|=0.0302
91689380|NCT05201794|183272533|SUPERIORITY||Odds Ratio (OR)|60.5|||=|0.2239|ONE_SIDED|80.0|-6.3|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||-6.3|=0.2239
91721502|NCT02966834|183335333|OTHER||LS mean ratio|3.128|||||TWO_SIDED|95.0|2.206|4.435||||||||4.435|2.206|
91721503|NCT02966834|183335333|OTHER||LS mean ratio|2.701|||||TWO_SIDED|95.0|1.915|3.81||||||||3.81|1.915|
91721504|NCT03513952|183335334|SUPERIORITY|||||||0.428||||||A one-sided significance level of 0.10 will be considered for the test.|Cochran-Mantel-Haenszel||||Estimations were done separately in each treatment arm; the difference between treatments was not calculated.|||0.428
91721505|NCT03513952|183335335|EQUIVALENCE|"Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or equivalence between treatments. A two-sided significance level of 0.05 will be considered for the test."|Risk Difference (RD)|-6.0||||0.702|TWO_SIDED|95.0|-36.3|24.3|||Cochran-Mantel-Haenszel|||||24.3|-36.3|0.702
91721506|NCT04739800|183335380|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.44|2.31|||||This is the Hazard Ratio of Group 2 compared to Group 1.|||2.31|0.44|
91689381|NCT06700512|183272551|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|paired||"H0 (Objective 1) SRT (study HA) is either not significantly different from SRT without HAs or significantly worse than SRT without HAs.~H1(Objective 1) SRT(study HA) is significantly better than SRT without HAs. A mean difference in SRT of 1 dB measured with the Oldenburg sentence test can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement."||||<0.001
91689382|NCT06700512|183272551|NON_INFERIORITY|A mean difference in SRT of 1 dB measured with the Oldenburg sentence test (Wagener et al, 1999a-c), can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement (Kollmeier et al, 2011). Thus if SRT with study hearing aids is 1dB or more worse than with subjects' own hearing aids and the difference is significant (p\<0.05), inferiority of study hearing aid is assumed otherwise study hearing aids are considered non-inferior|||||<|0.001||||||paired|t-test, 1 sided|||H0 (Objective 2) SRT (study HA) is significantly worse than SRT(own HAs). H1(Objective 2) There is no difference between SRT(study HA) and SRT(own HAs) or SRT (study HA) is significantly better than SRT (own HAs) SRT= Speech Reception Threshold in dB||||<0.001
91721507|NCT04739800|183335380|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.52|2.84|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||2.84|0.52|
91721508|NCT04739800|183335380|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||||This is the Hazard Ratio of Group 4 compared to Group 1.|3.08|0.58|
91721509|NCT04739800|183335383|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.44|4.47|||||This is the Hazard Ratio for Group 2 compared to Group 1.|||4.47|0.44|
91721510|NCT04739800|183335383|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.4|4.19|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||4.19|0.40|
91721511|NCT04739800|183335383|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||This is the Hazard Ratio of Group 4 compared to Group 1.|||3.08|0.58|
91721512|NCT05227677|183335385|SUPERIORITY|FAS analysis||||||0.9917||||||The threshold for statical significance was p=0.05.|Chi-squared|||||||0.9917
91721513|NCT05227677|183335385|SUPERIORITY|||||||0.6555|||||||Chi-squared|||PPS analysis||||0.6555
91721514|NCT05227677|183335386|SUPERIORITY|||||||0.0649||||||The threshold for statical significance was p=0.05.|Chi-squared|||FAS analysis||||0.0649
91721515|NCT05227677|183335386|SUPERIORITY|||||||0.0342|||||||Chi-squared|||PPS analysis||||0.0342
91721516|NCT05227677|183335387|SUPERIORITY|||||||0.2199||||||The threshold for statistical significance was p =0.05.|Chi-squared|||FAS Analysis||||0.2199
91721517|NCT05227677|183335387|SUPERIORITY|The threshold for statistical significance was p =0.05.||||||0.0769|||||||Chi-squared|||PPS analysis||||0.0769
91721518|NCT05227677|183335388|SUPERIORITY|||||||0.02||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0200
91721519|NCT05227677|183335388|SUPERIORITY|||||||0.0147|||||||Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0147
91721520|NCT05227677|183335389|SUPERIORITY|||||||0.0256||||||The threshold for statistical significance was p =0.05.|t-test, 2 sided|||FAS analysis||||0.0256
91721521|NCT05227677|183335389|SUPERIORITY|||||||0.0181||||||The threshold for statistical significance was p =0.05.|t-test, 2 sided|||PPS analysis||||0.0181
91721522|NCT05227677|183335390|EQUIVALENCE|Compare the percentage of hypoglycemia in each group and whether the percentage of hypoglycemia is equivalent between the GA guided therapy group and the Standard therapy group.|||||>|0.999||||||The threshold for statistical significance was p =0.05.|Fisher Exact|||At Visit3 (FAS)||||>0.999
91488608|NCT01011738|182849617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.595||||0.0019|TWO_SIDED|95.0|1.603|8.063||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||8.063|1.603|0.0019
91488609|NCT01011738|182849617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.851||||0.0369|TWO_SIDED|95.0|0.732|0.99||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Weight in kg was analyzed as independent predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.990|0.732|0.0369
91488610|NCT01011738|182849621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0033|TWO_SIDED|95.0|0.045|0.539||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.539|0.045|0.0033
91488611|NCT01011738|182849621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.191||||0.0042|TWO_SIDED|95.0|0.062|0.594|||Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||0.594|0.062|0.0042
91527119|NCT03445065|182929548|SUPERIORITY||Mean Difference (Net)|-1.8||||0.12935|TWO_SIDED|95.0|-4.1|0.5||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.5|-4.1|0.12935
91527120|NCT03445065|182929549|SUPERIORITY||Mean Difference (Net)|-0.1||||0.693|TWO_SIDED|95.0|-0.6|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.4|-0.6|0.693
91488612|NCT01011738|182849621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.528||||0.0149|TWO_SIDED|95.0|1.086|2.15||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, ALT ratio was analysed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||2.150|1.086|0.0149
91488613|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.38||1|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-0.8|1.000
91488614|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.7|-0.7|1.000
91488615|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.391|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.4|-1.0|0.391
91527121|NCT03445065|182929550|SUPERIORITY||Mean Difference (Net)|-0.9||||0.753|TWO_SIDED|95.0|-6.7|4.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.9|-6.7|0.753
91721523|NCT05227677|183335390|EQUIVALENCE|Compare the percentage of hypoglycemia in each group and whether the percentage of hypoglycemia is equivalent between the GA guided therapy group and the Standard therapy group.||||||0.6175||||||The threshold for statistical significance was p =0.05.|Fisher Exact|||At Visit 4 (FAS)||||0.6175
91488616|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.696|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.9|-0.6|0.696
91488617|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.921|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.8|-0.7|0.921
91488618|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.693|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.9|-0.6|0.693
91689405|NCT03657797|183272596|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.4||||0.2666|TWO_SIDED|95.0|-1.11|0.31||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 470 0.21% was compared to latanoprost.||0.31|-1.11|0.2666
91689406|NCT03657797|183272596|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.81||||0.0281|TWO_SIDED|95.0|-1.52|-0.09||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.042% was compared to latanoprost.||-0.09|-1.52|0.0281
91689407|NCT03657797|183272596|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-1.23||||0.0009|TWO_SIDED|95.0|-1.96|-0.51||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.065% was compared to latanoprost.||-0.51|-1.96|0.0009
91689408|NCT03657797|183272597|NON_INFERIORITY|NCX 470 0.021% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.9788||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.51 (week 1), 0.68 (week 2), 0.75 (exit visit); p-values were 0.5560 (week 1), 0.9788 (week 2), 0.8796 (exit visit)||NCX 470 0.021% was compared to latanoprost.||||<0.9788
91689409|NCT03657797|183272597|NON_INFERIORITY|NCX 470 0.042% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.3863||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.20 (week 1), 0.38 (week 2), 0.11 (exit visit); p-values were 0.1556 (week 1), 0.3863 (week 2), 0.0912 (exit visit)||NCX 470 0.042% was compared to latanoprost.||||<0.3863
91689410|NCT03657797|183272597|NON_INFERIORITY|NCX 470 0.065% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.0174||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were -0.35 (week 1), -0.15 (week 2), -0.27 (exit visit); p-values were 0.0040 (week 1), 0.0174 (week 2), 0.0093 (exit visit)||NCX 470 0.065% was compared to latanoprost.||||<0.0174
91689411|NCT01402570|183272607|SUPERIORITY_OR_OTHER||REML|0.17||||0.66|TWO_SIDED|95.0|-0.67|0.95||Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.95|-0.67|0.66
91488619|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.77|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.9|-0.7|0.770
91488620|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.98||0.938|TWO_SIDED|95.0|-3.7|4.0|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.0|-3.7|0.938
91527685|NCT01976364|182930493|OTHER||LS mean difference|0.73|||||TWO_SIDED|95.0|-1.49|2.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.95|-1.49|
91488621|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.52||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.5|-1.5|0.340
91527122|NCT03445065|182929550|SUPERIORITY||Mean Difference (Net)|-0.4||||0.84307|TWO_SIDED|95.0|-4.6|3.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effect, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.8|-4.6|0.84307
91689412|NCT01402570|183272608|SUPERIORITY_OR_OTHER||REML|0.0||||0.44|TWO_SIDED|95.0|-0.01|0.02||Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.02|-0.01|0.44
91689413|NCT01402570|183272609|SUPERIORITY_OR_OTHER||REML|145.54||||0.35|TWO_SIDED|95.0|-178.93|470.02||Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||470.02|-178.93|0.35
91689414|NCT01402570|183272610|SUPERIORITY_OR_OTHER||REML|-1.05||||0.07|TWO_SIDED|95.0|-2.21|0.1||Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.10|-2.21|0.07
91689415|NCT02019472|183272627|SUPERIORITY_OR_OTHER||LS mean difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.07|-0.46|||ANCOVA|||||-0.46|-1.07|< 0.001
91689416|NCT02019472|183272627|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.39|||=|0.013|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||||-0.08|-0.69|=0.013
91689417|NCT02019472|183272628|SUPERIORITY_OR_OTHER||Percentage Difference|-4.8||||0.306|TWO_SIDED|95.0|-14.1|4.4|||Cochran-Mantel-Haenszel|||||4.4|-14.1|0.306
91689418|NCT02019472|183272628|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.464|TWO_SIDED|95.0|-6.0|13.1|||Cochran-Mantel-Haenszel|||||13.1|-6|0.464
91689419|NCT02019472|183272629|SUPERIORITY_OR_OTHER||Percentage Difference|5.4||||0.086|TWO_SIDED|95.0|-0.7|11.4|||Cochran-Mantel-Haenszel|||||11.4|-0.7|0.086
91689420|NCT02019472|183272629|SUPERIORITY_OR_OTHER||Percentage Difference|12.8|||<|0.001|TWO_SIDED|95.0|5.9|19.7|||Cochran-Mantel-Haenszel|||||19.7|5.9|< 0.001
91689421|NCT02019472|183272630|SUPERIORITY_OR_OTHER||Percentage Difference|-2.7||||0.603|TWO_SIDED|95.0|-12.8|7.4|||Cochran-Mantel-Haenszel|||||7.4|-12.8|0.603
91689422|NCT02019472|183272630|SUPERIORITY_OR_OTHER||Percentage Difference|2.4||||0.644|TWO_SIDED|95.0|-7.6|12.3|||Cochran-Mantel-Haenszel|||||12.3|-7.6|0.644
91488622|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.258|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.4|-1.6|0.258
91689423|NCT03861390|183272637|OTHER|||||||0.24||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.24
91689424|NCT03861390|183272638|OTHER|||||||0.17||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.17
91689425|NCT03861390|183272639|OTHER|||||||0.7||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.70
91689426|NCT03861390|183272639|OTHER|||||||0.37||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.37
91689427|NCT03861390|183272640|OTHER|||||||0.77||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.77
91689428|NCT03861390|183272640|OTHER|||||||0.48||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.48
91689429|NCT03861390|183272641|OTHER|||||||0.96||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.96
91689430|NCT03861390|183272641|OTHER|||||||0.91||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.91
91689431|NCT03861390|183272642|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.46
91689432|NCT03861390|183272642|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.46
91689433|NCT03861390|183272643|OTHER|||||||0.82||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.82
91689434|NCT03861390|183272643|OTHER|The a priori threshold for statistical significance is \< 0.05.||||||0.99|||||||Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.99
91689435|NCT03861390|183272644|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
91689436|NCT03861390|183272644|OTHER|||||||0.84||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.84
91689437|NCT03861390|183272645|OTHER|||||||0.49||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.49
91689438|NCT03861390|183272645|OTHER|||||||0.52||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.52
91689439|NCT02157935|183272647|SUPERIORITY_OR_OTHER||Rate ratio|0.76||||0.0059|TWO_SIDED|95.0|0.62|0.92|||Negative binomial model|||||0.92|0.62|0.0059
91488623|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.49||0.381|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.5|-1.4|0.381
91689440|NCT02157935|183272648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Regression, Cox|||||0.96|0.64|0.0164
91689441|NCT02157935|183272649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343||||0.007|TWO_SIDED|95.0|-2.318|-0.368|||Mixed Models Analysis|||||-0.368|-2.318|0.0070
91689442|NCT02157935|183272650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.0091|TWO_SIDED|95.0|0.008|0.053|||Mixed Models Analysis|||||0.053|0.008|0.0091
91721524|NCT05227677|183335390|EQUIVALENCE|Compare the percentage of hypoglycemia in each group and whether the percentage of hypoglycemia is equivalent between the GA guided therapy group and the Standard therapy group.|||||>|0.999||||||The threshold for statistical significance was p =0.05.|Fisher Exact|||At Visit 3 (PPS)||||>0.999
91721525|NCT05227677|183335390|EQUIVALENCE|Compare the percentage of hypoglycemia in each group and whether the percentage of hypoglycemia is equivalent between the GA guided therapy group and the Standard therapy group.||||||0.5979||||||The threshold for statistical significance was p =0.05.|Fisher Exact|||At Visit4 (PPS)||||0.5979
91527123|NCT03445065|182929551|SUPERIORITY||Mean Difference (Net)|-0.9||||0.653|TWO_SIDED|95.0|-4.8|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-4.8|0.653
91689443|NCT02157935|183272651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.203||||0.0082|TWO_SIDED|95.0|-0.353|-0.053|||ANCOVA|||||-0.053|-0.353|0.0082
91689444|NCT02157935|183272652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.0048|TWO_SIDED|95.0|-0.048|-0.009|||ANCOVA|||||-0.009|-0.048|0.0048
91689445|NCT03192488|183272658|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.047|TWO_SIDED|95.0|0.01|2.11|||ANOVA|"The overall model was adjusted for the co-variate VO2max."||||2.11|0.01|0.047
91689446|NCT03192488|183272659|SUPERIORITY|||||||0.327|||||||ANOVA|||||||0.327
91689447|NCT03192488|183272659|SUPERIORITY|||||||0.557|||||||ANOVA|||||||0.557
91488624|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.287|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.5|-1.6|0.287
91527124|NCT03445065|182929551|SUPERIORITY||Mean Difference (Net)|2.3||||0.07261|TWO_SIDED|95.0|-0.2|4.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.8|-0.2|0.07261
91689448|NCT00611923|183272665|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.57|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 1 between flutamide and placebo groups||||= 0.57
91689449|NCT00611923|183272665|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.27|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 2 between flutamide and placebo groups.||||= .27
91689450|NCT00611923|183272666|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.52|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 1 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.52
91689451|NCT00611923|183272666|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 2 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.2
91689452|NCT00611923|183272667|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.8|||||||t-test, 2 sided|||||||= 0.8
91689453|NCT00611923|183272667|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1|||||||t-test, 2 sided|||||||= 0.1
91689454|NCT00611923|183272668|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.15|||||||t-test, 2 sided|||paired t-test was performed comparing the Clinical Global Improvement score at month 1 between placebo and flutamide groups||||=.15
91689455|NCT00611923|183272668|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.05|||||||t-test, 2 sided|||t-test was performed comparing the Clinical Global Improvement score at month 2 between placebo and flutamide groups||||= .05
91689456|NCT00611923|183272669|SUPERIORITY_OR_OTHER_LEGACY|Comparison of change from baseline score to treatment month 1 between placebo and flutamide treated subjects.|||||=|0.5|||||||t-test, 2 sided|||||||=0.5
91689457|NCT00611923|183272669|SUPERIORITY_OR_OTHER_LEGACY|paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups|||||<|0.04|||||||t-test, 2 sided|||||||<.04
91689458|NCT00611923|183272670|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test was performed comparing the Patient Global Improvement score at month 1 between placebo and flutamide groups||||=0.2
91689459|NCT00611923|183272670|SUPERIORITY_OR_OTHER_LEGACY|paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups|||||=|0.06|||||||t-test, 2 sided|||||||=0.06
91689460|NCT00572936|183272673|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for significance was \<0.05|ANOVA|||||||<.05
91689461|NCT00572936|183272674|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
91689462|NCT00572936|183272675|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.93||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.93
91689463|NCT00572936|183272676|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.84||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.84
91721526|NCT05227677|183335391|SUPERIORITY|||||||0.0404||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0404
91721527|NCT05227677|183335391|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0330
91721528|NCT05227677|183335392|SUPERIORITY|||||||0.0408||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0408
91488625|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.42|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.6|-1.5|0.420
91488626|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53||0.227|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.4|-1.7|0.227
91488627|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.427|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.6|-1.5|0.427
91488628|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|2.7||0.256|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||2.2|-8.4|0.256
91488629|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.62||0.198|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||2.0|-0.4|0.198
91488630|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.132|TWO_SIDED|95.0|-0.3|2.1|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||2.1|-0.3|0.132
91527125|NCT03445065|182929552|SUPERIORITY||Mean Difference (Net)|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.4|-4.9|0.685
91689464|NCT00572936|183272677|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
91689465|NCT00572936|183272678|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.89||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.89
91488631|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.58||0.227|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||1.8|-0.4|0.227
91488632|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.63||0.208|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||2.0|-0.4|0.208
91488633|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.63||0.265|TWO_SIDED|95.0|-0.5|1.9|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.9|-0.5|0.265
91488634|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.34|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||1.8|-0.6|0.340
91488635|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.64||0.347|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.9|-0.7|0.347
91689466|NCT00572936|183272679|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences between outflow facility for the three interventions|||||<|0.05||||||threshold for statistical significance was \<0.05|Kruskal-Wallis|||||||<0.05
91689467|NCT00572936|183272680|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences in uveoscleral outflow between the three interventions|||||<|0.05||||||threshold for statistical analysis was \<0.05|Kruskal-Wallis|||||||<0.05
91689468|NCT02806908|183272681|SUPERIORITY|||||||0.0022|||||||ANOVA|||||||0.0022
91689469|NCT02806908|183272682|SUPERIORITY|||||||0.0416|||||||ANOVA|||||||0.0416
91689470|NCT02806908|183272683|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
91689471|NCT02806908|183272684|SUPERIORITY|||||||0.3018|||||||McNemar|||||||0.3018
91689472|NCT02806908|183272685|SUPERIORITY|||||||0.424|||||||McNemar|||||||0.4240
91689473|NCT02806908|183272686|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
91721529|NCT05227677|183335392|SUPERIORITY|||||||0.0322||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0322
91721530|NCT05227677|183335393|SUPERIORITY|||||||0.0303||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0303
91721531|NCT05227677|183335393|SUPERIORITY|||||||0.0264||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0264
91689474|NCT02806908|183272687|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
91689475|NCT02806908|183272688|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91689476|NCT02806908|183272689|SUPERIORITY|||||||0.6291|||||||McNemar|||||||0.6291
91689477|NCT02806908|183272690|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91689478|NCT02806908|183272691|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91689479|NCT02806908|183272692|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91689480|NCT02806908|183272693|SUPERIORITY|||||||0.7744|||||||McNemar|||||||0.7744
91721532|NCT05227677|183335394|SUPERIORITY|||||||0.0374||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0374
91721533|NCT05227677|183335394|SUPERIORITY|||||||0.0313||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0313
91721534|NCT05227677|183335395|SUPERIORITY|||||||0.0086||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0086
91721535|NCT05227677|183335395|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0156
91721536|NCT05227677|183335396|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0118
91721537|NCT05227677|183335396|SUPERIORITY|||||||0.0191||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0191
91689481|NCT02806908|183272694|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
91689482|NCT02806908|183272695|SUPERIORITY|||||||0.1141|||||||ANOVA|||||||0.1141
91689483|NCT02806908|183272696|SUPERIORITY|||||||0.4441|||||||ANOVA|||||||0.4441
91689484|NCT02806908|183272697|SUPERIORITY|||||||0.3423|||||||ANOVA|||||||0.3423
91689485|NCT02806908|183272698|SUPERIORITY|||||||0.9384|||||||ANOVA|||||||0.9384
91689486|NCT02806908|183272699|SUPERIORITY|||||||0.0939|||||||ANOVA|||||||0.0939
91689487|NCT02806908|183272700|SUPERIORITY|||||||0.0246|||||||ANOVA|||||||0.0246
91689488|NCT02806908|183272701|SUPERIORITY|||||||0.1475|||||||ANOVA|||||||0.1475
91689489|NCT02806908|183272702|SUPERIORITY|||||||0.1513|||||||ANOVA|||||||0.1513
91689490|NCT02806908|183272703|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
91689491|NCT02806908|183272704|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
91689492|NCT02806908|183272705|SUPERIORITY|||||||0.4774|||||||ANOVA|||||||0.4774
91689493|NCT02806908|183272706|SUPERIORITY|||||||0.3801|||||||ANOVA|||||||0.3801
91689494|NCT02806908|183272707|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91689495|NCT01760304|183272708|SUPERIORITY|||||||0.769|||||||2-sided paired t-test|||a paired t-test was calculated comparing baseline measures and post intervention||||0.769
91689496|NCT01760304|183272708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired T-test|||a paired t-test was calculated comparing baseline measures and post intervention||||<0.0001
91689497|NCT01760304|183272710|SUPERIORITY_OR_OTHER||||||<|0.05|||||||paired t-test|||||||<0.05
91689498|NCT04429503|183272712|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|Least Square (LS) Mean Difference|-0.57|||<|0.0001|TWO_SIDED|95.0|-2.26|1.13|||Mixed Model for Repeated Measurements||HDq12 minus 2q8|||1.13|-2.26|<0.0001
91689499|NCT04429503|183272712|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|LS Mean Difference|-1.44||||0.0031|TWO_SIDED|95.0|-3.27|0.39|||Mixed Model for Repeated Measurements||HDq16 minus 2q8|||0.39|-3.27|0.0031
91689500|NCT04429503|183272713|NON_INFERIORITY|The non-inferiority margin was set at 15%|Adjusted Difference (%)|1.98|||||TWO_SIDED|95.0|-6.61|10.57|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||10.57|-6.61|
91689501|NCT04429503|183272713|NON_INFERIORITY|The non-inferiority margin was set at 15%.|Adjusted Difference (%)|-7.52|||||TWO_SIDED|95.0|-16.88|1.84|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||1.84|-16.88|
91689502|NCT05516108|183272734|OTHER|||||||0.004|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.004
91689503|NCT05516108|183272735|OTHER|||||||0.02|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.020
91721538|NCT05227677|183335397|SUPERIORITY|||||||0.0057||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||||||0.0057
91721539|NCT05227677|183335397|SUPERIORITY|||||||0.0175||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0175
91721540|NCT05227677|183335398|SUPERIORITY|||||||0.0065||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||FAS analysis||||0.0065
91721541|NCT05227677|183335398|SUPERIORITY|||||||0.0188||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||PPS analysis||||0.0188
91721542|NCT05227677|183335399|SUPERIORITY|||||||0.0087||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||||||0.0087
91721543|NCT05227677|183335399|SUPERIORITY|||||||0.0152||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||||||0.0152
91721544|NCT05227677|183335400|SUPERIORITY|||||||0.0103||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||||||0.0103
91721545|NCT05227677|183335400|SUPERIORITY|||||||0.0176||||||The threshold for statistical significance was p =0.05.|Wilcoxon (Mann-Whitney)|||||||0.0176
91721546|NCT03573297|183335401|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5745|TWO_SIDED|95.0|0.48|1.43||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.43|0.48|0.5745
91488636|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|4.3|STANDARD_ERROR_OF_MEAN|3.19||0.179|TWO_SIDED|95.0|-2.0|10.6|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||10.6|-2.0|0.179
91488637|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|Least Square (LS) Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.57||0.556|TWO_SIDED|95.0|-1.4|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-1.4|0.556
91527126|NCT03445065|182929552|SUPERIORITY||Mean Difference (Net)|3.1||||0.19785|TWO_SIDED|95.0|-1.6|7.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.8|-1.6|0.19785
91689504|NCT05516108|183272736|OTHER|||||||0.74|||||||Mixed Models Analysis|Stata melogit||time (pre, post, follow-up) x condition (mindfulness, coping)||||.74
91488638|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.76|TWO_SIDED|95.0|-1.2|0.9|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.9|-1.2|0.760
91689505|NCT05516108|183272737|OTHER|||||||0.1|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.10
91689506|NCT05516108|183272738|OTHER|||||||0.009|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.009
91689507|NCT03664232|183272778|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09|=|0.284|TWO_SIDED|80.0|-0.17|0.07|||Mixed effects model for repeatedmeasures|||||0.07|-0.17|=0.284
91689508|NCT03664232|183272779|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.29|TWO_SIDED|80.0|-0.18|0.07|||MMRM|||||0.07|-0.18|=0.290
91689509|NCT03664232|183272780|SUPERIORITY||Least-Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1|=|0.231|TWO_SIDED|80.0|-0.21|0.06|||MMRM|||||0.06|-0.21|=0.231
91689510|NCT02717507|183272798|OTHER||Slope|0.163|STANDARD_ERROR_OF_MEAN|0.112||0.15|TWO_SIDED|95.0|-0.057|0.383|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.||0.383|-0.057|0.15
91689511|NCT02717507|183272799|OTHER||Slope|-3.764|STANDARD_ERROR_OF_MEAN|1.705||0.03|TWO_SIDED|95.0|-7.105|-0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.424|-7.105|0.03
91689512|NCT02717507|183272800|OTHER||Slope|-0.045|STANDARD_ERROR_OF_MEAN|0.023||0.05|TWO_SIDED|95.0|-0.09|0.001|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.001|-0.09|0.05
91721547|NCT03573297|183335401|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6308|TWO_SIDED|95.0|0.52|1.51||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.51|0.52|0.6308
91488639|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.636|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.8|-1.3|0.636
91689513|NCT02717507|183272801|OTHER||Slope|-2.194|STANDARD_ERROR_OF_MEAN|1.605||0.17|TWO_SIDED|95.0|-5.34|0.951|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.|||0.951|-5.34|0.17
91689514|NCT02717507|183272802|OTHER||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.01|TWO_SIDED|95.0|-141.0|-0.024|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.024|-0141|0.01
91689515|NCT02717507|183272803|OTHER||Slope|-2.397|STANDARD_ERROR_OF_MEAN|2.603||0.36|TWO_SIDED|95.0|-7.499|2.704|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEDV was statistically significant at a two-sided p\<0.05 and the expected LVEDV was lower for carvedilol than placebo over time.|||2.704|-7.499|0.36
91689516|NCT02717507|183272804|OTHER||Slope|0.433|STANDARD_ERROR_OF_MEAN|0.799||0.59|TWO_SIDED|95.0|-1.134|1.999|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||1.999|-1.134|0.59
91689517|NCT02717507|183272805|OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.302||0.84|TWO_SIDED|95.0|-0.652|0.532|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive|||0.532|-0.652|0.84
91721548|NCT02696798|183335417|SUPERIORITY||Odds Ratio (OR)|2.41||||0.017|TWO_SIDED|95.0|1.17|4.95|||Regression, Logistic|||||4.95|1.17|0.017
91689518|NCT02717507|183272806|OTHER||Slope|0.259|STANDARD_ERROR_OF_MEAN|0.373||0.49|TWO_SIDED|95.0|-0.472|0.991|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEF was statistically significant at a two-sided p\<0.05 and the expected LVEF was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVEF across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 1.2-1.6 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVEF at 24m.||0.991|-0.472|0.49
91689519|NCT02717507|183272807|OTHER||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.82|TWO_SIDED|95.0|-0.065|0.082|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.082|-0.065|0.82
91721549|NCT02696798|183335417|SUPERIORITY||Odds Ratio (OR)|3.06||||0.003|TWO_SIDED|95.0|1.48|6.33|||Regression, Logistic|||||6.33|1.48|0.003
91721550|NCT02696798|183335418|SUPERIORITY||Odds Ratio (OR)|2.2||||0.006|TWO_SIDED|95.0|1.26|3.84|||Regression, Logistic|||||3.84|1.26|0.006
91689520|NCT02717507|183272808|OTHER||Slope|2.121|STANDARD_ERROR_OF_MEAN|1.79||0.24|TWO_SIDED|95.0|-1.387|5.63|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||5.63|-1.387|0.24
91689521|NCT02717507|183272809|OTHER||Slope|5.113|STANDARD_ERROR_OF_MEAN|8.532||0.55|TWO_SIDED|95.0|-11.608|21.835|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||21.835|-11.608|0.55
91689522|NCT02717507|183272810|OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.51|TWO_SIDED|95.0|-0.004|0.002|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.002|-0.004|0.51
91689523|NCT02717507|183272811|OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.228||0.92|TWO_SIDED|95.0|-0.468|0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.424|-0.468|0.92
91689524|NCT02717507|183272813|OTHER||Slope|0.024|STANDARD_ERROR_OF_MEAN|0.104||0.82|TWO_SIDED|95.0|-0.18|0.229|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|||0.229|-0.18|0.82
91689525|NCT02717507|183272814|OTHER||Slope|-0.096|STANDARD_ERROR_OF_MEAN|2.439||0.97|TWO_SIDED|95.0|-4.877|4.685|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||4.685|-4.877|0.97
91689526|NCT02717507|183272815|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|3.491||0.72|TWO_SIDED|95.0|-5.595|8.091|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.||8.091|-5.595|0.72
91689527|NCT05017246|183272818|SUPERIORITY||Mean Difference (Final Values)|-44.9||||0.0249|TWO_SIDED|95.0|-84.0|-5.8|||Two-sample t-test|Unadjusted analysis|Intrathecal - Epidural|||-5.8|-84.0|0.0249
91721551|NCT02696798|183335418|SUPERIORITY||Odds Ratio (OR)|2.08||||0.013|TWO_SIDED|95.0|1.16|3.73|||Regression, Logistic|||||3.73|1.16|0.013
91721552|NCT02696798|183335419|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-1.32|-0.79|||Mixed Models Analysis|||||-0.79|-1.32|<0.001
91721553|NCT02696798|183335419|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.3|-0.75|||Mixed Models Analysis|||||-0.75|-1.30|<0.001
91721554|NCT02696798|183335420|SUPERIORITY||Odds Ratio (OR)|2.65||||0.015|TWO_SIDED|95.0|1.21|5.84|||Regression, Logistic|||||5.84|1.21|0.015
91721555|NCT02696798|183335420|SUPERIORITY||Odds Ratio (OR)|2.9||||0.01|TWO_SIDED|95.0|1.29|6.49|||Regression, Logistic|||||6.49|1.29|0.010
91721556|NCT02696798|183335421|SUPERIORITY||LS Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.291|<|0.001|TWO_SIDED|95.0|-1.81|-0.67|||Mixed Models Analysis|||||-0.67|-1.81|<0.001
91488640|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.774|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||1.0|-1.3|0.774
91689528|NCT05017246|183272819|SUPERIORITY||Risk Ratio (RR)|1.04||||0.94|TWO_SIDED|95.0|0.36|3.01|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||3.01|0.36|0.94
91689529|NCT05017246|183272820|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.59|TWO_SIDED|95.0|-1.01|0.48|||Bootstrap resampling method|Bootstrap resampling method based on raw data was applied for due to highly right-skewed data (5,000 Bootstrap samples were selected).|Intrathecal - Epidural|||0.48|-1.01|0.59
91689530|NCT05017246|183272821|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.61|1.48|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||1.48|0.61|0.82
91689531|NCT05017246|183272824|SUPERIORITY||Risk Ratio (RR)|1.56||||0.67|TWO_SIDED|95.0|0.27|8.95|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||8.95|0.27|0.67
91689532|NCT05017246|183272825|SUPERIORITY||Risk Ratio (RR)|2.08||||0.61|TWO_SIDED|95.0|0.19|22.2|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||22.2|0.19|0.61
91488641|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.57||0.771|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.0|-1.3|0.771
91689533|NCT02493660|183272827|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (\<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.||||||0.0049|||||||Regression, Logistic|Primary analysis method was for month 12 success with age (\<65 years, ≥65 years), sex, and treatment as the model covariates.||||||0.0049
91689534|NCT02493660|183272830|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints.|||||<|0.05|||||||Regression, Logistic|||Results from logistic regression model.||||<0.05
91689535|NCT03500198|183272883|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
91689536|NCT03500198|183272885|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91689537|NCT03500198|183272886|SUPERIORITY||||||<|0.0001|||||||1-sided logistic regression|||||||<0.0001
91689538|NCT02440464|183272895|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.10.|Log Rank|||The null hypothesis is that there is no difference in progression-free survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||1.0
91689539|NCT02440464|183272896|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with acute grade III-IV GVHD between the Ixazomib and Placebo arms during 100 days post-randomization, with death prior to acute GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
91689540|NCT02440464|183272897|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to chronic GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
91721557|NCT02696798|183335421|SUPERIORITY||LS Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.301|<|0.001|TWO_SIDED|95.0|-1.76|-0.57|||Mixed Models Analysis|||||-0.57|-1.76|<0.001
91721558|NCT02696798|183335422|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.295|<|0.001|TWO_SIDED|95.0|-1.63|-0.47|||Mixed Models Analysis|||||-0.47|-1.63|<0.001
91721559|NCT02696798|183335422|SUPERIORITY||LS Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.89|-0.68|||Mixed Models Analysis|||||-0.68|-1.89|<0.001
91721560|NCT02696798|183335423|SUPERIORITY||Odds Ratio (OR)|3.73||||0.242|TWO_SIDED|95.0|0.41|33.98|||Regression, Logistic|||||33.98|0.41|0.242
91721561|NCT02696798|183335423|SUPERIORITY||Odds Ratio (OR)|5.42||||0.127|TWO_SIDED|95.0|0.62|47.54|||Regression, Logistic|||||47.54|0.62|0.127
91488642|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.468|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.7|-1.5|0.468
91721562|NCT02696798|183335424|SUPERIORITY||Odds Ratio (OR)|4.22||||0.006|TWO_SIDED|95.0|1.5|11.86|||Regression, Logistic|||||11.86|1.50|0.006
91721563|NCT02696798|183335424|SUPERIORITY||Odds Ratio (OR)|4.52||||0.006|TWO_SIDED|95.0|1.55|13.18|||Regression, Logistic|||||13.18|1.55|0.006
91721564|NCT02696798|183335425|SUPERIORITY||LS Mean Difference (Final Values)|0.7689|STANDARD_ERROR_OF_MEAN|1.2863||0.55|TWO_SIDED|95.0|-1.7629|3.3007|||Mixed Models Analysis|||MCS||3.3007|-1.7629|0.550
91721565|NCT02696798|183335425|SUPERIORITY||LS Mean Difference (Final Values)|0.9104|STANDARD_ERROR_OF_MEAN|1.3338||0.495|TWO_SIDED|95.0|-1.7151|3.536|||Mixed Models Analysis|||MCS||3.5360|-1.7151|0.495
91721566|NCT02696798|183335425|SUPERIORITY||LS Mean Difference (Final Values)|5.2147|STANDARD_ERROR_OF_MEAN|1.1149|<|0.001|TWO_SIDED|95.0|3.0204|7.409|||Mixed Models Analysis|||PCS||7.4090|3.0204|<0.001
91721567|NCT02696798|183335425|SUPERIORITY||LS Mean Difference (Final Values)|4.7585|STANDARD_ERROR_OF_MEAN|1.1505|<|0.001|TWO_SIDED|95.0|2.494|7.023|||Mixed Models Analysis|||PCS||7.0230|2.4940|<0.001
91721568|NCT02696798|183335426|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.46||0.026|TWO_SIDED|95.0|-1.94|-0.13|||Mixed Models Analysis|||||-0.13|-1.94|0.026
91689541|NCT02440464|183272898|SUPERIORITY|The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||||0.89|||||||Fisher Exact|Statistical significance was determined using a pre-specified one-sided threshold of 0.05.||Participants in sCR/CR at Randomization||||0.890
91689542|NCT02440464|183272898|SUPERIORITY|||||||0.754||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants not in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||0.754
91689543|NCT02440464|183272900|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with progression between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
91689544|NCT02440464|183272901|SUPERIORITY|||||||0.174||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference in overall survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||0.174
91689545|NCT02440464|183272902|SUPERIORITY|||||||0.173||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with treatment-related mortality between the Ixazomib and Placebo arms during 21 months post-randomization, with progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||0.173
91689546|NCT02440464|183272904|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
91721569|NCT02696798|183335426|SUPERIORITY||LS Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.477||0.149|TWO_SIDED|95.0|-1.63|0.25|||Mixed Models Analysis|||||0.25|-1.63|0.149
91721570|NCT02696798|183335427|SUPERIORITY||LS Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.512|<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||ANCOVA|||||-0.9|-3.0|<0.001
91721571|NCT02696798|183335427|SUPERIORITY||LS Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.534|<|0.001|TWO_SIDED|95.0|-3.2|-1.1|||ANCOVA|||||-1.1|-3.2|<0.001
91721572|NCT02696798|183335428|SUPERIORITY||LS Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.896||0.001|TWO_SIDED|95.0|-10.0|-2.5|||ANCOVA|||||-2.5|-10.0|0.001
91721573|NCT02696798|183335428|SUPERIORITY||LS Mean Difference (Final Values)|-7.27|STANDARD_ERROR_OF_MEAN|1.978|<|0.001|TWO_SIDED|95.0|-11.2|-3.4|||ANCOVA|||||-3.4|-11.2|<0.001
91721574|NCT02696798|183335429|SUPERIORITY||LS Mean Difference (Final Values)|-20.816|STANDARD_ERROR_OF_MEAN|3.7463|<|0.001|TWO_SIDED|95.0|-28.187|-13.444|||Mixed Models Analysis|||||-13.444|-28.187|<0.001
91721575|NCT02696798|183335429|SUPERIORITY||LS Mean Difference (Final Values)|-17.841|STANDARD_ERROR_OF_MEAN|3.9018|<|0.001|TWO_SIDED|95.0|-25.518|-10.163|||Mixed Models Analysis|||||-10.163|-25.518|<0.001
91488643|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.886|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.1|-1.2|0.886
91721576|NCT02696798|183335430|SUPERIORITY||LS Mean Difference (Final Values)|-0.304|STANDARD_ERROR_OF_MEAN|0.1275||0.018|TWO_SIDED|95.0|-0.555|-0.053|||Mixed Models Analysis|||||-0.053|-0.555|0.018
91721577|NCT02696798|183335430|SUPERIORITY||LS Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.1319||0.194|TWO_SIDED|95.0|-0.431|0.088|||Mixed Models Analysis|||||0.088|-0.431|0.194
91721578|NCT02696798|183335431|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|0.893||0.17|TWO_SIDED|95.0|-0.53|2.99|||Mixed Models Analysis|||||2.99|-0.53|0.170
91721579|NCT02696798|183335431|SUPERIORITY||LS Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.916||0.8|TWO_SIDED|95.0|-1.57|2.04|||Mixed Models Analysis|||||2.04|-1.57|0.800
91721580|NCT02696798|183335432|SUPERIORITY||LS Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.521||0.547|TWO_SIDED|95.0|-1.34|0.71|||Mixed Models Analysis|||||0.71|-1.34|0.547
91721581|NCT02696798|183335432|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.538||0.064|TWO_SIDED|95.0|-2.06|0.06|||Mixed Models Analysis|||||0.06|-2.06|0.064
91721582|NCT02696798|183335433|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.861|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||||1.3|-1.0|0.861
91721583|NCT02696798|183335433|SUPERIORITY||LS Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.59||0.626|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||||0.9|-1.4|0.626
91721584|NCT02696798|183335434|SUPERIORITY||LS Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.59||0.504|TWO_SIDED|95.0|-1.6|0.8|||Mixed Models Analysis|||||0.8|-1.6|0.504
91721585|NCT02696798|183335434|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.86|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||||1.3|-1.1|0.860
91721586|NCT02696798|183335435|SUPERIORITY||LS Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.362|TWO_SIDED|95.0|-3.0|1.1|||Mixed Models Analysis|||||1.1|-3.0|0.362
91721587|NCT02696798|183335435|SUPERIORITY||LS Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.08||0.303|TWO_SIDED|95.0|-3.3|1.0|||Mixed Models Analysis|||||1.0|-3.3|0.303
91721588|NCT02696798|183335436|SUPERIORITY||LS Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.813|TWO_SIDED|95.0|-1.5|1.2|||Mixed Models Analysis|||||1.2|-1.5|0.813
91488644|NCT01346969|182849644|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|2.91||0.668|TWO_SIDED|95.0|-7.0|4.5|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.5|-7.0|0.668
91488645|NCT01967173|182849650|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.003
91488646|NCT01967173|182849650|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.9
91721589|NCT02696798|183335436|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.41|TWO_SIDED|95.0|-2.0|0.8|||Mixed Models Analysis|||||0.8|-2.0|0.410
91721590|NCT02696798|183335438|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||||-0.6|-1.9|<0.001
91721591|NCT02696798|183335438|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34||0.005|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||||-0.3|-1.6|0.005
91721592|NCT02696798|183335439|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.68||0.088|TWO_SIDED|95.0|-2.5|0.2|||Mixed Models Analysis|||||0.2|-2.5|0.088
91721593|NCT02696798|183335439|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.366|TWO_SIDED|95.0|-2.0|0.7|||Mixed Models Analysis|||||0.7|-2.0|0.366
91689547|NCT02440464|183272904|SUPERIORITY|||||||0.252||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.252
91689548|NCT02440464|183272904|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
91689549|NCT02440464|183272906|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
91689550|NCT02440464|183272906|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
91689551|NCT02440464|183272906|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
91689552|NCT02568072|183272921|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
91689553|NCT02568072|183272922|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
91689554|NCT02568072|183272923|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
91721594|NCT02696798|183335440|SUPERIORITY||LS Mean Difference (Final Values)|-11.13|STANDARD_ERROR_OF_MEAN|5.323||0.038|TWO_SIDED|95.0|-21.65|-0.6|||ANCOVA|||Overall Work Impairment Score||-0.60|-21.65|0.038
91721595|NCT02696798|183335440|SUPERIORITY||LS Mean Difference (Final Values)|-13.66|STANDARD_ERROR_OF_MEAN|5.341||0.012|TWO_SIDED|95.0|-24.23|-3.1|||ANCOVA|||Overall Work Impairment Score||-3.10|-24.23|0.012
91488647|NCT01967173|182849650|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500||||<0.001
91689555|NCT02714218|183272932|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0144|TWO_SIDED|95.0|0.38|0.9|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.90|0.38|0.0144
91689556|NCT02714218|183272932|SUPERIORITY||Estimated Difference of rates|-12.7|||||TWO_SIDED|95.0|-22.7|-2.6|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-2.6|-22.7|
91689557|NCT02714218|183272933|SUPERIORITY||Odds Ratio (OR)|0.55||||0.0059|TWO_SIDED|95.0|0.36|0.84|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.84|0.36|0.0059
91721596|NCT02696798|183335440|SUPERIORITY||LS Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|3.5||0.071|TWO_SIDED|95.0|-13.2|0.5|||ANCOVA|||Percentage of Activity Impairment||0.5|-13.2|0.071
91721597|NCT02696798|183335440|SUPERIORITY||LS Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|3.65||0.024|TWO_SIDED|95.0|-15.5|-1.1|||ANCOVA|||Percentage of Activity Impairment||-1.1|-15.5|0.024
91721598|NCT04880850|183335444|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin glargine) was strictly below 0.3%.|Treatment difference|0.02|||<|0.0001|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||0.15|-0.11|<0.0001
91721599|NCT04091451|183335454|NON_INFERIORITY|The non-inferiority was to be demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the ratio of the incidence of HZ recurrence between HZ/su group and Placebo group was below (\<) 5.|Incidence Rate Ratio (IRR)|0.0|||||TWO_SIDED|95.0|0.0|0.46|||Poisson||IRR = incidence rate of HZ recurrence in HZ/su group divided by the incidence rate of HZ recurrence in Placebo group. Poisson method was used to adjust for differences in follow-up time across individuals.|To demonstrate the non-inferiority of HZ/su vaccine compared to placebo in terms of incidence of HZ recurrence from 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months).||0.46|0.00|
91721600|NCT03074500|183335468|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||Comparison of baseline values||||0.643
91721601|NCT03074500|183335468|SUPERIORITY|||||||0.018|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.018
91721602|NCT03074500|183335468|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Comparison of 4 week After Treatment Values||||0.027
91721603|NCT03074500|183335468|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
91721604|NCT03074500|183335468|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
91488648|NCT01967173|182849650|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.42
91689558|NCT02714218|183272933|SUPERIORITY||Estimated Difference of rates|-14.4|||||TWO_SIDED|95.0|-24.5|-4.3|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-4.3|-24.5|
91689559|NCT02714218|183272934|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2923|TWO_SIDED|95.0|0.53|1.21|||Cochran-Mantel-Haenszel||p-value from CMH Test for the comparison of the odds ratio of N3I1 over N1I3|||1.21|0.53|0.2923
91689560|NCT02714218|183272935|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.79|1.47|||||Hazard Ratio is N3I1 over N1I3. (NIVO 3 + IPI 1 (N3I1) over NIVO 1 + IPI 3 (N1I3))|||1.47|0.79|
91689561|NCT02714218|183272936|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4512|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||||1.48|0.84|0.4512
91689562|NCT01422200|183272952|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91721605|NCT03074500|183335468|SUPERIORITY|||||||0.326||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.326
91488649|NCT01967173|182849650|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.84
91689563|NCT01113892|183272957|NON_INFERIORITY|"The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products."|Mean Difference (Net)|16.4|||<|0.0001|TWO_SIDED|95.0|2.7|29.9||The threshold for significance was p = .05|Exact 1-sided test||Difference = Patency (Fusion Bioline) - Patency (EXXCEL)|It was calculated that 200 participants randomized in a 1:1 fashion would have at least 80% power to detect a difference of 15% in the number of participants with primary patency between FUSION Bioline and EXXCEL groups at 6 months. It was assumed that the ratio of Above-Knee to Below-Knee procedures was 60:40; based on this, the primary patency rate for the combined Above-Knee and Below-Knee patients was 79%. Assumptions included a 10% withdrawal rate prior to the 6-month evaluation.||29.9|2.7|<.0001
91689564|NCT01113892|183272958|EQUIVALENCE|Fisher's Exact test was used to evaluate whether subjects with any MALE event or POD were homogeneous across the treatment arms.||||||0.033|ONE_SIDED|95.0|||||Fisher Exact|||The number and percentage of subjects with a MALE or POD event were summarized by treatment group.||||.033
91689565|NCT01113892|183272959|OTHER|||||||0.017|||||||Chi-squared|Proportion of subjects who achieved primary assisted patency for both treatment groups were compared using a Chi-Square test||||||.017
91689566|NCT01113892|183272960|OTHER|||||||0.137|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi-Square test||||||.137
91721606|NCT03074500|183335468|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.019
91721607|NCT03074500|183335468|SUPERIORITY|||||||0.014||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.014
91721608|NCT03074500|183335468|SUPERIORITY|||||||0.427||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.427
91721609|NCT03074500|183335468|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
91721610|NCT03074500|183335468|SUPERIORITY|||||||0.021||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.021
91721611|NCT03074500|183335468|SUPERIORITY|||||||0.545||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Value||||0.545
91721612|NCT03074500|183335468|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
91721613|NCT03074500|183335468|SUPERIORITY|||||||0.67|||||||Friedman's two-way analysis of variance|||||||0.670
91721614|NCT03074500|183335468|SUPERIORITY|||||||0.192|||||||Friedman's two-way analysis of variance|||||||0.192
91721615|NCT03074500|183335469|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||Comparison of Before Treatment Values||||0.633
91721616|NCT03074500|183335469|SUPERIORITY|||||||0.282|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.282
91721617|NCT03074500|183335469|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.015
91721618|NCT03074500|183335469|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.677
91721619|NCT03074500|183335469|SUPERIORITY|||||||0.344||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.344
91721620|NCT03074500|183335469|SUPERIORITY|||||||0.596||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.596
91721621|NCT03074500|183335469|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
91721622|NCT03074500|183335469|SUPERIORITY|||||||0.257||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.257
91721623|NCT03074500|183335469|SUPERIORITY|||||||0.449||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.449
91689567|NCT01113892|183272961|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Difference between groups were compared with the Wilcoxon Rank Sum Test||||<.0001
91689568|NCT01113892|183272963|NON_INFERIORITY|"Repeated 6 month analyses for 12 month results.The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate for FUSION Bioline (PF), and the primary patency rate for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products, with a p-value ≤ .05 indicating significance."|Mean Difference (Net)|9.5||||0.0001|TWO_SIDED|95.0|-4.8|23.0|||Exact 1-sided test|||||23.0|-4.8|.0001
91689569|NCT01113892|183272965|OTHER|||||||0.181|||||||Chi-squared|Proportion of subjects who achieve primary assisted patency for both treatment groups will be compared using a Chi-Square test||||||.181
91689570|NCT01113892|183272967|OTHER|||||||0.68|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi Square test||||||.68
91689571|NCT00789854|183272971|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-2.322||||||97.5|-4.6|-0.05||The CI is for comparing add-on quetiapine versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The -0.05 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between add-on quetiapine XR and add-on lithium was shown in the Per Protocol analysis set.||Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium.||-0.05|-4.6|
91689572|NCT00789854|183272971|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-1.639||||||97.5|-3.24|1.312||The CI is for comparing quetiapine XR mono versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The 1.312 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between quetiapine XR mono and add-on lithium was shown in the Per Protocol analysis set.||Quetiapine XR mono was tested versus add-on lithium for non-inferiority. The null hypothesis was that the quetiapine XR mono treatment was non-inferior to add-on lithium.||1.312|-3.24|
91689573|NCT00789854|183272972|SUPERIORITY_OR_OTHER|||||||0.0489||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the add-on quetiapine XR treatment was not different to the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.0489
91689574|NCT00789854|183272972|SUPERIORITY_OR_OTHER|||||||0.4368||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the quetiapine XR mono treatment was not different from the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.4368
91689575|NCT02756611|183273026|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
91689576|NCT02756611|183273037|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
91689577|NCT01015534|183273061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9||||0.019|TWO_SIDED|95.0|1.3|12.9||The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29|Chi-squared|||||12.9|1.3|0.019
91689578|NCT01015534|183273062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.704|TWO_SIDED|95.0|0.138|3.422|||Fisher Exact|||||3.422|.138|.704
91689579|NCT01015534|183273063|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Log Rank|||||||0.84
91689580|NCT01422213|183273065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.22|0.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the mixed model for repeated measurements (MMRM) with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.50|0.22|<0.0001
91689581|NCT01422213|183273065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.19|0.47||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.47|0.19|<0.0001
91488650|NCT01967173|182849650|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500||||0.015
91721624|NCT03074500|183335469|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
91689582|NCT01422213|183273066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|2.5|5.9||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.90|2.50|<0.0001
91689583|NCT01422213|183273066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|2.57|5.94||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.94|2.57|<0.0001
91689584|NCT01422213|183273067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.46||0.0287|TWO_SIDED|95.0|0.11|1.93||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.93|0.11|0.0287
91689585|NCT01422213|183273067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.46||0.1988|TWO_SIDED|95.0|-0.31|1.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.50|-0.31|0.1988
91689586|NCT01422213|183273068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0033|TWO_SIDED|95.0|0.24|1.19||Since the p-value for RAVLT acquisition for 10 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.19|0.24|0.0033
91689587|NCT01422213|183273068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.24||0.0073|TWO_SIDED|95.0|0.17|1.12||Since the p-value for RAVLT acquisition for 20 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.12|0.17|0.0073
91689588|NCT01422213|183273069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.37||0.0061|TWO_SIDED|95.0|-6.45|-1.08||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.08|-6.45|0.0061
91689589|NCT01422213|183273069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.35||0.0052|TWO_SIDED|95.0|-6.46|-1.14||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.14|-6.46|0.0052
91689590|NCT01422213|183273070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.57|STANDARD_ERROR_OF_MEAN|2.73||0.0058|TWO_SIDED|95.0|-12.93|-2.2||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.20|-12.93|0.0058
91689591|NCT01422213|183273070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.01|STANDARD_ERROR_OF_MEAN|2.7||0.0009|TWO_SIDED|95.0|-14.32|-3.7||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-3.70|-14.32|0.0009
91689592|NCT01422213|183273071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.28||0.0018|TWO_SIDED|95.0|-6.5|-1.49||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.49|-6.50|0.0018
91721625|NCT03074500|183335469|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.019
91488651|NCT01967173|182849650|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.085
91488652|NCT01967173|182849650|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.62
91689593|NCT01422213|183273071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.26||0.0005|TWO_SIDED|95.0|-6.93|-1.97||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.97|-6.93|0.0005
91689594|NCT01422213|183273072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-10.76|-2.74||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.74|-10.76|0.0010
91689595|NCT01422213|183273072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.52|STANDARD_ERROR_OF_MEAN|2.02||0.0013|TWO_SIDED|95.0|-10.49|-2.54||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.54|-10.49|0.0013
91689596|NCT01422213|183273073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.07|-0.02||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.02|-0.07|0.0002
91689597|NCT01422213|183273073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0157|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0157
91689598|NCT01422213|183273074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.009||0.0005|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0005
91689599|NCT01422213|183273074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.009||0.3549|TWO_SIDED|95.0|-0.03|0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||0.01|-0.03|0.3549
91689600|NCT01422213|183273075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.45|-2.96||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.96|-6.45|<0.0001
91689601|NCT01422213|183273075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-8.43|-4.98||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-4.98|-8.43|<0.0001
91689602|NCT01422213|183273076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.88|-0.42||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.42|-0.88|<0.0001
91689603|NCT01422213|183273076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.08|-0.62||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.62|-1.08|<0.0001
91689604|NCT01422213|183273077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.4||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.40|-0.81|<0.0001
91689605|NCT01422213|183273077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.06|-0.65||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.65|-1.06|<0.0001
91689606|NCT01422213|183273078|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0002|TWO_SIDED|95.0|1.44|3.33||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.33|1.44|0.0002
91689607|NCT01422213|183273078|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||<|0.0001|TWO_SIDED|95.0|2.26|5.21||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.21|2.26|<0.0001
91488653|NCT01967173|182849650|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250||||0.48
91488654|NCT01967173|182849650|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100||||0.14
91488655|NCT01967173|182849650|SUPERIORITY|||||||0.096|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100||||0.096
91488656|NCT02128932|182849738|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.67|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.||-0.67|-0.96|<0.0001
91488657|NCT02128932|182849738|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%).|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.52|-0.24|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.||-0.24|-0.52|<0.0001
91488658|NCT03685123|182849747|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|||||||0.256
91488659|NCT03685123|182849748|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
91689608|NCT01422213|183273079|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.003|TWO_SIDED|95.0|1.29|3.41||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.41|1.29|0.0030
91689609|NCT01422213|183273079|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|1.95|5.03||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.03|1.95|<0.0001
91689610|NCT01422213|183273080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.059||0.0393|TWO_SIDED|95.0|0.01|0.24||No adjustment for multiplicity was made.|ANCOVA|||||0.24|0.01|0.0393
91689611|NCT01422213|183273081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.068||0.0007|TWO_SIDED|95.0|0.1|0.36||No adjustment for multiplicity was made.|ANCOVA|||||0.36|0.10|0.0007
91488660|NCT03685123|182849749|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||||||0.244
91527127|NCT03445065|182929553|SUPERIORITY||Mean Difference (Net)|-0.4||||0.549|TWO_SIDED|95.0|-1.5|0.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.8|-1.5|0.549
91689612|NCT01422213|183273081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.068||0.0246|TWO_SIDED|95.0|0.02|0.29||No adjustment for multiplicity was made.|ANCOVA|||||0.29|0.02|0.0246
91689613|NCT04782076|183273106|OTHER||LS Mean Difference (Final Values)|1.43|||||TWO_SIDED|90.0|1.33|1.55|||Mixed Models Analysis|Least Squares Mean (LS Mean)||||1.55|1.33|
91488661|NCT03685123|182849750|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
91488662|NCT03685123|182849751|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|||LDL levels||||0.983
91488663|NCT03685123|182849751|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||HDL levels||||0.56
91527686|NCT01976364|182930493|OTHER||LS mean difference|-0.79|||||TWO_SIDED|95.0|-3.1|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-3.10|
91488664|NCT03685123|182849751|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Total Cholesterol||||0.71
91488665|NCT03685123|182849751|SUPERIORITY|||||||0.313|||||||Mixed Models Analysis|||Triglycerides||||0.313
91488666|NCT03685123|182849752|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||systolic Blood pressure||||0.72
91488667|NCT03685123|182849752|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||Diastolic Blood pressure||||0.61
91488668|NCT03685123|182849752|SUPERIORITY|||||||0.1609|||||||Mixed Models Analysis|||Change in aortic blood pressure between the PA-REC and the WM-REC Groups.||||0.1609
91488669|NCT03685123|182849752|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Change in aortic diastolic blood pressure between the PA-REC and WM-REC Groups||||0.446
91488670|NCT03685123|182849753|SUPERIORITY|||||||0.965|||||||Mixed Models Analysis|||||||0.965
91488671|NCT03685123|182849754|SUPERIORITY|||||||0.857|||||||Mixed Models Analysis|||||||0.857
91488672|NCT03685123|182849755|SUPERIORITY|||||||0.825|||||||Mixed Models Analysis|||||||0.825
91488673|NCT03685123|182849756|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.061
91488674|NCT03685123|182849758|SUPERIORITY|Change in particle size between the PA-REC and WM-REC groups||||||0.105|||||||Mixed Models Analysis|||Change in HDL particle size||||0.105
91488675|NCT03685123|182849758|SUPERIORITY|Change in particle size between the PA-REC and the WM-REC groups||||||0.849|||||||Mixed Models Analysis|||Change in LDL particles||||0.849
91488676|NCT03685123|182849760|SUPERIORITY|||||||0.278|||||||ANOVA|||Change in steps per day from week 10 to week 28||||0.278
91488677|NCT03685123|182849761|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Change in SF-36 General Health (GH)||||0.238
91488678|NCT03685123|182849761|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.124|||||||Mixed Models Analysis|||Change in SF-36 Physical health (PH)||||0.124
91488679|NCT03685123|182849761|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.769|||||||Mixed Models Analysis|||Change in SF-36 role physical||||0.769
91689614|NCT04782076|183273107|OTHER||LS Mean Difference (Final Values)|1.38|||||TWO_SIDED|90.0|1.3|1.46|||Mixed Models Analysis|||||1.46|1.30|
91689615|NCT02547428|183273133|SUPERIORITY||Treatment difference|-8.1|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-11.0|-5.1|||ANCOVA||Sample size of 60 participants (30 per treatment sequence) was needed to provide minimum 85% power to detect 5 point difference between treatments at a 2-sided significance level of 5% using a paired t-test.|Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR and placebo. The analysis of covariance (ANCOVA) model included terms for period, sequence, and treatment as fixed effects, and Baseline score as a covariate, and a participate-within-sequence term as a random effect.||-5.1|-11.0|<0.001
91689616|NCT02547428|183273134|SUPERIORITY||Treatment difference|-7.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.7|-3.6|||ANCOVA|||Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR 400 mg/day and placebo.||-3.6|-10.7|<0.001
91689617|NCT01634048|183273156|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91689618|NCT06192589|183273160|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.43|||<|0.01|TWO_SIDED|90.0|1.34|1.52||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.52|1.34|<0.01
91689619|NCT06192589|183273161|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12|||<|0.01|TWO_SIDED|90.0|1.06|1.17||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.06|<0.01
91689620|NCT06192589|183273162|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.34|TWO_SIDED|90.0|0.96|1.16|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.16|0.96|0.34
91689621|NCT06192589|183273162|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.1|TWO_SIDED|90.0|1.0|1.26|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.26|1.00|0.10
91689622|NCT06192589|183273163|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.19||||0.02|TWO_SIDED|90.0|1.05|1.35|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.35|1.05|0.02
91689623|NCT06192589|183273163|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.29|TWO_SIDED|90.0|0.94|1.3|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.30|0.94|0.29
91689624|NCT06192589|183273170|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.01||||0.47|TWO_SIDED|90.0|0.98|1.05|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.05|0.98|0.47
91689625|NCT06192589|183273170|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.99||||0.73|TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.03|0.96|0.73
91689626|NCT06192589|183273171|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.03|TWO_SIDED|90.0|1.03|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.03|0.03
91689627|NCT06192589|183273171|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.98||||0.66|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.06|0.91|0.66
91721626|NCT03074500|183335469|SUPERIORITY|||||||0.325||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.325
91721627|NCT03074500|183335469|SUPERIORITY|||||||0.003|||||||Friedman's two-way analysis of variance|||||||0.003
91488680|NCT03685123|182849761|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.352|||||||Mixed Models Analysis|||Change in SF-36 Bodily Pain||||0.352
91721628|NCT03074500|183335469|SUPERIORITY|||||||0.323|||||||Friedman's two-way analysis of variance|||||||0.323
91721629|NCT03074500|183335469|SUPERIORITY|||||||0.641|||||||Friedman's two-way analysis of variance|||||||0.641
91721630|NCT03074500|183335470|SUPERIORITY|||||||0.715|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.715
91721631|NCT03074500|183335470|SUPERIORITY|||||||0.227|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.227
91721632|NCT03074500|183335470|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.012
91721633|NCT03074500|183335470|SUPERIORITY|||||||0.907||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.907
91689628|NCT06192589|183273172|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies.|Geometric mean ratio|1.08||||0.13|TWO_SIDED|90.0|0.99|1.18|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.18|0.99|0.13
91689629|NCT06192589|183273172|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.26|||<|0.01|TWO_SIDED|90.0|1.17|1.36|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.36|1.17|<0.01
91689630|NCT06192589|183273173|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.08||||0.12|TWO_SIDED|90.0|1.0|1.17|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.00|0.12
91689631|NCT06192589|183273173|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.07|TWO_SIDED|90.0|1.01|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.01|0.07
91689632|NCT00742209|183273183|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.3||||0.579|TWO_SIDED|95.0|-0.6|1.1||A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.|ANCOVA|An ANCOVA model with baseline number of MHD and IHS Headache Classification for presence or absence of aura as covariates was used.|Adjusted mean difference versus placebo|||1.1|-0.6|0.579
91689633|NCT01332487|183273213|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Acute Urinary Retention|Chi-squared|||||||0.002
91689634|NCT01332487|183273213|SUPERIORITY_OR_OTHER|||||||0||95.0||||Surgery|Chi-squared|||||||0.000
91689635|NCT01332487|183273213|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Emergency Surgery|Chi-squared|||||||0.597
91689636|NCT01514461|183273228|SUPERIORITY_OR_OTHER||% change from reference treatment|-28.78||||0.0538|TWO_SIDED|95.0|-55.69|14.46|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||14.46|-55.69|0.0538
91689637|NCT01514461|183273228|SUPERIORITY_OR_OTHER||% change from reference treatment|-40.88||||0.0182|TWO_SIDED|95.0|-63.99|-2.94|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||-2.94|-63.99|0.0182
91689638|NCT03290378|183273367|SUPERIORITY||||||<|0.005|TWO_SIDED|95.0|||||ANCOVA|||||||<.005
91689639|NCT01062425|183273382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||One-sided test with significance level of 0.15.|Z-test|||The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.||||0.005
91721634|NCT03074500|183335470|SUPERIORITY|||||||0.482||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.482
91721635|NCT03074500|183335470|SUPERIORITY|||||||0.485||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.485
91721636|NCT03074500|183335470|SUPERIORITY|||||||0.129||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.129
91689640|NCT01062425|183273383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.44|TWO_SIDED|95.0|0.6|1.24||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||1.24|0.6|0.44
91689641|NCT01062425|183273383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.648|TWO_SIDED|95.0|0.62|1.34|||Regression, Cox||Placebo is reference level for the hazard ratio.|Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.||1.34|0.62|0.648
91721637|NCT03074500|183335470|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
91721638|NCT03074500|183335470|SUPERIORITY|||||||0.935||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.935
91721639|NCT03074500|183335470|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.002
91721640|NCT03074500|183335470|SUPERIORITY|||||||0.036||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.036
91689642|NCT01062425|183273384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.03|TWO_SIDED|95.0|0.47|0.95||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||0.95|0.47|0.03
91689643|NCT01062425|183273384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.036|TWO_SIDED|95.0|0.46|0.97|||Regression, Cox||Placebo is the reference arm.|Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.||0.97|0.46|0.036
91689644|NCT01062425|183273385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Significance level 0.05, two-sided test.|Chi-squared|||||||0.02
91488681|NCT03685123|182849761|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.898|||||||Mixed Models Analysis|||Change in SF-36 Vitality||||0.898
91689645|NCT01037218|183273386|SUPERIORITY_OR_OTHER||Difference in LS Means|3.38|||<|0.0001|TWO_SIDED|95.0|1.7|5.07|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||5.07|1.70|<0.0001
91689646|NCT01037218|183273386|SUPERIORITY_OR_OTHER||Difference in LS Means|5.74|||<|0.0001|TWO_SIDED|95.0|4.05|7.43|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||7.43|4.05|<0.0001
91689647|NCT01037218|183273386|SUPERIORITY_OR_OTHER||Difference in LS Means|7.53|||<|0.0001|TWO_SIDED|95.0|5.86|9.2|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||9.20|5.86|<0.0001
91689648|NCT01037218|183273387|SUPERIORITY_OR_OTHER||Difference in LS Means|20.19|||<|0.0001|TWO_SIDED|95.0|13.44|26.93|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.93|13.44|<0.0001
91689649|NCT01037218|183273387|SUPERIORITY_OR_OTHER||Difference in LS Means|25.06|||<|0.0001|TWO_SIDED|95.0|18.32|31.81|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||31.81|18.32|<0.0001
91689650|NCT01037218|183273387|SUPERIORITY_OR_OTHER||Difference in LS Means|32.84|||<|0.0001|TWO_SIDED|95.0|26.18|39.5|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||39.50|26.18|<0.0001
91689651|NCT01037218|183273388|SUPERIORITY_OR_OTHER||Difference in LS Means|21.72|||<|0.0001|TWO_SIDED|95.0|14.19|29.24|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||29.24|14.19|<0.0001
91721641|NCT03074500|183335470|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.056
91721642|NCT03074500|183335470|SUPERIORITY|||||||0.016|||||||Friedman's two-way analysis of variance|||||||0.016
91721643|NCT03074500|183335470|SUPERIORITY|||||||0.618|||||||Friedman's two-way analysis of variance|||||||0.618
91721644|NCT03074500|183335470|SUPERIORITY|||||||0.48|||||||Friedman's two-way analysis of variance|||||||0.48
91721645|NCT03074500|183335470|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.034
91721646|NCT03074500|183335470|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.041
91721647|NCT03074500|183335470|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||1
91721648|NCT03074500|183335471|SUPERIORITY|||||||0.103|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.103
91721649|NCT03074500|183335471|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.002
91488682|NCT03685123|182849761|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.444|||||||Mixed Models Analysis|||Change in SF-36 social function||||0.444
91488683|NCT03685123|182849761|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health||||0.537
91488684|NCT03685123|182849761|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||Change in SF-36 Role Emotional||||0.448
91488685|NCT03685123|182849761|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health (Sum)||||0.537
91488686|NCT03685123|182849761|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.482|||||||Mixed Models Analysis|||Change in SF-36 Physical Health (sum)||||0.482
91689652|NCT01037218|183273388|SUPERIORITY_OR_OTHER||Difference in LS Means|26.82|||<|0.0001|TWO_SIDED|95.0|19.27|34.37|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||34.37|19.27|<0.0001
91689653|NCT01037218|183273388|SUPERIORITY_OR_OTHER||Difference in LS Means|35.41|||<|0.0001|TWO_SIDED|95.0|27.98|42.83|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||42.83|27.98|<0.0001
91689654|NCT01037218|183273389|SUPERIORITY_OR_OTHER||Difference in LS Means|1.52|||<|0.0001|TWO_SIDED|95.0|0.81|2.23|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.23|0.81|<0.0001
91689655|NCT01037218|183273389|SUPERIORITY_OR_OTHER||Difference in LS Means|2.29|||<|0.0001|TWO_SIDED|95.0|1.58|3.0|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.00|1.58|<0.0001
91527128|NCT03445065|182929553|SUPERIORITY||Mean Difference (Net)|-3.3||||0.0318|TWO_SIDED|95.0|-6.3|-0.3||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.3|-6.3|0.03180
91689656|NCT01037218|183273389|SUPERIORITY_OR_OTHER||Difference in LS Means|2.9|||<|0.0001|TWO_SIDED|95.0|2.2|3.6|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.60|2.20|<0.0001
91689657|NCT01037218|183273390|SUPERIORITY_OR_OTHER||Difference in LS Means|0.59||||0.0673|TWO_SIDED|95.0|-0.04|1.22|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.22|-0.04|0.0673
91721650|NCT03074500|183335471|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.008
91721651|NCT03074500|183335471|SUPERIORITY|||||||0.76||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.76
91689658|NCT01037218|183273390|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.9|2.16|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.16|0.90|<0.0001
91689659|NCT01037218|183273390|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.91|2.15|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.15|0.91|<0.0001
91721652|NCT03074500|183335471|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
91721653|NCT03074500|183335471|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.056
91721654|NCT03074500|183335471|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.002
91721655|NCT03074500|183335471|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
91689660|NCT01037218|183273391|SUPERIORITY_OR_OTHER||Difference in LS Means|0.36||||0.0566|TWO_SIDED|95.0|-0.01|0.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.73|-0.01|0.0566
91689661|NCT01037218|183273391|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0002|TWO_SIDED|95.0|0.34|1.08|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.08|0.34|0.0002
91689662|NCT01037218|183273391|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0001|TWO_SIDED|95.0|0.34|1.07|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.07|0.34|0.0001
91689663|NCT01037218|183273392|SUPERIORITY_OR_OTHER||Difference in LS Means|0.86||||0.0019|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.40|0.32|0.0019
91689664|NCT01037218|183273392|SUPERIORITY_OR_OTHER||Difference in LS Means|1.55|||<|0.0001|TWO_SIDED|95.0|1.01|2.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.09|1.01|<0.0001
91689665|NCT01037218|183273392|SUPERIORITY_OR_OTHER||Difference in LS Means|2.09|||<|0.0001|TWO_SIDED|95.0|1.55|2.62|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.62|1.55|<0.0001
91689666|NCT01037218|183273393|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
91689667|NCT01037218|183273393|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
91689668|NCT01037218|183273393|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
91689669|NCT01037218|183273393|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
91689670|NCT01037218|183273394|SUPERIORITY_OR_OTHER||Difference in LS Means|12.65|||<|0.0001|TWO_SIDED|95.0|7.01|18.29|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||18.29|7.01|<0.0001
91721656|NCT03074500|183335471|SUPERIORITY|||||||0.117||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.117
91689671|NCT01037218|183273394|SUPERIORITY_OR_OTHER||Difference in LS Means|19.61|||<|0.0001|TWO_SIDED|95.0|13.95|25.27|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.27|13.95|<0.0001
91689672|NCT01037218|183273394|SUPERIORITY_OR_OTHER||Difference in LS Means|27.01|||<|0.0001|TWO_SIDED|95.0|21.44|32.59|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||32.59|21.44|<0.0001
91721657|NCT03074500|183335471|SUPERIORITY|||||||0.006||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.006
91689673|NCT01037218|183273395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.57|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.57|0.30|<0.0001
91689674|NCT01037218|183273395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.68|0.40|<0.0001
91689675|NCT01037218|183273395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.83|||<|0.0001|TWO_SIDED|95.0|0.69|0.97|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.97|0.69|<0.0001
91689676|NCT01037218|183273396|SUPERIORITY_OR_OTHER||Difference in LS Means|15.18|||<|0.0001|TWO_SIDED|95.0|10.21|20.14|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||20.14|10.21|<0.0001
91689677|NCT01037218|183273396|SUPERIORITY_OR_OTHER||Difference in LS Means|14.94|||<|0.0001|TWO_SIDED|95.0|9.96|19.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||19.92|9.96|<0.0001
91689678|NCT01037218|183273396|SUPERIORITY_OR_OTHER||Difference in LS Means|21.06|||<|0.0001|TWO_SIDED|95.0|16.15|25.96|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.96|16.15|<0.0001
91721658|NCT03074500|183335471|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
91721659|NCT03074500|183335471|SUPERIORITY|||||||0.487||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.487
91721660|NCT03074500|183335471|SUPERIORITY|||||||0.002|||||||Friedman's two-way analysis of variance|||||||0.002
91721661|NCT03074500|183335471|SUPERIORITY|||||||0.102|||||||Friedman's two-way analysis of variance|||||||0.102
91721662|NCT03074500|183335471|SUPERIORITY|||||||0.165|||||||Friedman's two-way analysis of variance|||||||0.165
91721663|NCT03074500|183335471|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.007
91721664|NCT03074500|183335471|SUPERIORITY|||||||0.028|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.028
91488687|NCT03685123|182849763|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91488688|NCT03685123|182849764|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
91488689|NCT03685123|182849765|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in body fat||||<0.001
91689679|NCT01037218|183273397|SUPERIORITY_OR_OTHER||Difference in LS Means|17.51|||<|0.0001|TWO_SIDED|95.0|10.22|24.81|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||24.81|10.22|<0.0001
91689680|NCT01037218|183273397|SUPERIORITY_OR_OTHER||Difference in LS Means|28.32|||<|0.0001|TWO_SIDED|95.0|21.01|35.62|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||35.62|21.01|<0.0001
91689681|NCT01037218|183273397|SUPERIORITY_OR_OTHER||Difference in LS Means|33.82|||<|0.0001|TWO_SIDED|95.0|26.61|41.02|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||41.02|26.61|<0.0001
91689682|NCT01037218|183273398|SUPERIORITY_OR_OTHER||Difference in LS Means|18.73|||<|0.0001|TWO_SIDED|95.0|11.23|26.23|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.23|11.23|<0.0001
91689683|NCT01037218|183273398|SUPERIORITY_OR_OTHER||Difference in LS Means|29.39|||<|0.0001|TWO_SIDED|95.0|21.86|36.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||36.92|21.86|<0.0001
91689684|NCT01037218|183273398|SUPERIORITY_OR_OTHER||Difference in LS Means|34.35|||<|0.0001|TWO_SIDED|95.0|26.94|41.75|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).||41.75|26.94|<0.0001
91689685|NCT02291237|183273414|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.55||||0.416|TWO_SIDED|95.0|-1.87|0.78|||ANCOVA|P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.||The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).||0.78|-1.87|0.416
91689686|NCT02291237|183273415|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.42||||0.517|TWO_SIDED|95.0|-1.68|0.85||P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.|ANCOVA|||The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).||0.85|-1.68|0.517
91689687|NCT02291237|183273416|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|1.54||||0.513|TWO_SIDED|95.0|-3.11|6.19|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||6.19|-3.11|0.513
91689688|NCT02291237|183273417|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.1||||0.964|TWO_SIDED|95.0|-4.36|4.56|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||4.56|-4.36|0.964
91721665|NCT03074500|183335471|SUPERIORITY|||||||0.83|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.83
91721666|NCT03074500|183335472|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.837
91721667|NCT03074500|183335472|SUPERIORITY|||||||0.215|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.215
91689689|NCT02291237|183273418|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.04||||0.944|TWO_SIDED|95.0|-1.18|1.1|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||1.10|-1.18|0.944
91689690|NCT02291237|183273419|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.0||||0.993|TWO_SIDED|95.0|-0.96|0.97|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||0.97|-0.96|0.993
91689691|NCT07034820|183273420|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|48.0|64.0||A priori statistical significance threshold for the primary endpoint was set at a two-sided alpha level of 0.05. No adjustment for multiple comparisons was applied to the primary outcome analysis, as it was the sole primary endpoint.|Chi-squared||The Risk Difference (RD) indicates the absolute difference in hemorrhoid regression rates between the Nimsai Herbal Group and the Placebo Group. Calculation: Nimsai Herbal (78%) - Placebo (22%) = 56%.|Powered for 56% difference (80% power, alpha=0.05) to detect the anticipated difference in hemorrhoid regression rates between groups. The sample size of N=300 (150 participants per arm) was calculated based on an expected regression rate of 22% in the placebo group and 78% in the Nimsai Herbal group. This ensured sufficient statistical power for the primary efficacy analysis.||64|48|<0.001
91689692|NCT02189837|183273421|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|88.76|STANDARD_ERROR_OF_MEAN|36.67||0.018|TWO_SIDED|95.0|15.73|161.8|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||161.80|15.73|0.018
91689693|NCT02189837|183273421|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|236.35|STANDARD_ERROR_OF_MEAN|36.32|<|0.001|TWO_SIDED|95.0|164.02|308.69|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||308.69|164.02|<0.001
91689694|NCT02189837|183273421|SUPERIORITY_OR_OTHER||Treatment Effect|147.59|STANDARD_ERROR_OF_MEAN|51.61||0.005|TWO_SIDED|95.0|44.8|250.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||250.38|44.80|0.005
91689695|NCT02189837|183273422|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|-65.91|-48.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-48.38|-65.91|<0.001
91689696|NCT02189837|183273422|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.95|STANDARD_ERROR_OF_MEAN|4.31|<|0.001|TWO_SIDED|95.0|-46.55|-29.34|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-29.34|-46.55|<0.001
91721668|NCT03074500|183335472|SUPERIORITY|||||||0.078|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.078
91488690|NCT03685123|182849766|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91488691|NCT03685123|182849767|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||LDL||||0.004
91689697|NCT02189837|183273422|SUPERIORITY_OR_OTHER||Treatment Effect|19.2|STANDARD_ERROR_OF_MEAN|6.15||0.003|TWO_SIDED|95.0|6.93|31.47|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||31.47|6.93|0.003
91689698|NCT02189837|183273423|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.65|STANDARD_ERROR_OF_MEAN|10.41||0.11|TWO_SIDED|95.0|-37.37|4.08|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||4.08|-37.37|0.11
91689699|NCT02189837|183273423|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-32.66|STANDARD_ERROR_OF_MEAN|10.31||0.002|TWO_SIDED|95.0|-53.19|-12.13|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-12.13|-53.19|0.002
91689700|NCT02189837|183273423|SUPERIORITY_OR_OTHER||Treatment Effect|-16.01|STANDARD_ERROR_OF_MEAN|14.65||0.28|TWO_SIDED|95.0|-45.18|13.16|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||13.16|-45.18|0.28
91689701|NCT02189837|183273424|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-2.12|STANDARD_ERROR_OF_MEAN|13.4||0.87|TWO_SIDED|95.0|-28.94|24.7|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||24.70|-28.94|0.87
91689702|NCT02189837|183273424|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|39.06|STANDARD_ERROR_OF_MEAN|12.76||0.003|TWO_SIDED|95.0|13.52|64.59|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||64.59|13.52|0.003
91689703|NCT02189837|183273424|SUPERIORITY_OR_OTHER||Treatment Effect|41.18|STANDARD_ERROR_OF_MEAN|18.5||0.03|TWO_SIDED|95.0|4.15|78.2|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||78.20|4.15|0.030
91689704|NCT02189837|183273425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.43|STANDARD_ERROR_OF_MEAN|11.6||0.001|TWO_SIDED|95.0|-62.66|-16.21|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-16.21|-62.66|0.001
91689705|NCT02189837|183273425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|23.28|STANDARD_ERROR_OF_MEAN|11.05||0.039|TWO_SIDED|95.0|1.16|45.4|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||45.40|1.16|0.039
91689706|NCT02189837|183273425|SUPERIORITY_OR_OTHER||Treatment Effect|62.72|STANDARD_ERROR_OF_MEAN|16.02|<|0.001|TWO_SIDED|95.0|30.65|94.79|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||94.79|30.65|<0.001
91689707|NCT03787134|183273486|SUPERIORITY|||||||0.335|||||||t-test, 2 sided|||cued memory item reconstruction - test of reconstruction strength against 0||||.335
91689708|NCT03787134|183273486|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||uncued memory item reconstruction - test of reconstruction strength against 0||||.016
91689709|NCT03281876|183273502|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group. The objective is to be considered a success if the lower limit of the 87% CI is above 0%.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|87.0|-18.27|11.58|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||11.58|-18.27|0.8157
91689710|NCT03281876|183273503|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|95.0|-23.45|15.29|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||15.29|-23.45|0.8157
91721669|NCT03074500|183335472|SUPERIORITY|||||||0.699||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.699
91721670|NCT03074500|183335472|SUPERIORITY|||||||0.846||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.846
91488692|NCT03685123|182849767|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Change in HDL||||0.04
91488693|NCT03685123|182849767|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in Total Cholesterol||||<0.001
91488694|NCT03685123|182849767|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Triglycerides||||<0.001
91488695|NCT03685123|182849768|SUPERIORITY|||||||0.01||||||Systolic blood pressure|Mixed Models Analysis|||||||0.01
91488696|NCT03685123|182849768|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Diastolic blood pressure||||0.001
91689711|NCT03281876|183273510|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the control group.|Vaccine efficacy rate|-2.72||||0.77|TWO_SIDED|95.0|-22.95|14.19|||Negative Binomial regression|||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of AECOPDs of any severity- upto 12 months follow up period||14.19|-22.95|0.7700
91689712|NCT03281876|183273512|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.94||||0.5751|TWO_SIDED|95.0|0.758|1.166|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2||1.166|0.758|0.5751
91689713|NCT03281876|183273513|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.934||||0.5194|TWO_SIDED|95.0|0.758|1.15|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2||1.15|0.758|0.5194
91689714|NCT03281876|183273514|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.05||||0.8581|TWO_SIDED|95.0|0.616|1.791|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2||1.791|0.616|0.8581
91689715|NCT03281876|183273514|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.995||||0.9634|TWO_SIDED|95.0|0.792|1.249|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2||1.249|0.792|0.9634
91689716|NCT03281876|183273514|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.722||||0.1755|TWO_SIDED|95.0|0.45|1.157|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2||1.157|0.45|0.1755
91689717|NCT03281876|183273521|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.038||||0.9463|TWO_SIDED|95.0|0.73|1.477|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.477|0.73|0.9463
91689718|NCT03281876|183273522|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.093||||0.6042|TWO_SIDED|95.0|0.782|1.528|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.528|0.782|0.6042
91689719|NCT03281876|183273523|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|2.243||||0.0777|TWO_SIDED|95.0|0.914|5.504|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||5.504|0.914|0.0777
91689720|NCT03281876|183273523|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.021||||0.9121|TWO_SIDED|95.0|0.71|1.467|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.467|0.71|0.9121
91689721|NCT03281876|183273523|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.12||||0.8737|TWO_SIDED|95.0|0.278|4.502|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||4.502|0.278|0.8737
91689722|NCT02208089|183273535|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Null hypothesis = TransPRK produced no gains in vision over and above those produced by CXL only||||0.03
91689723|NCT02208089|183273536|SUPERIORITY|||||||0.005|||||||Chi-squared|||Null hypothesis = an equal proportion of patients in both study arms have clinically significant visual gains||||0.005
91689724|NCT02208089|183273537|NON_INFERIORITY|Non-inferiority = no significant difference between rates of clinically significant visual loss between groups at the p≤0.05 level||||||0.13|||||||Chi-squared|||null hypothesis = rates of clinically significant visual loss are equal for TransPRKCXL and CXL only||||0.13
91689725|NCT00683657|183273552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.16||0.0001|TWO_SIDED|95.0|-25.1|-8.5||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pre treatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-8.5|-25.1|0.0001
91488697|NCT03685123|182849768|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Aortic blood pressure (mmHg)||||<0.001
91721671|NCT03074500|183335472|SUPERIORITY|||||||0.56||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.56
91721672|NCT03074500|183335472|SUPERIORITY|||||||0.087||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.087
91488698|NCT03685123|182849768|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in aortic diastolic pressure||||<0.001
91689726|NCT00683657|183273553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-44.4|-16.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-16.1|-44.4|<0.0001
91689727|NCT00683657|183273554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.4|STANDARD_ERROR_OF_MEAN|10.41||0.001|TWO_SIDED|95.0|-56.2|-14.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-14.7|-56.2|0.0010
91689728|NCT00683657|183273555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|STANDARD_ERROR_OF_MEAN|4.22|<|0.0001|TWO_SIDED|95.0|-27.1|-10.3||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-10.3|-27.1|<0.0001
91689729|NCT00683657|183273556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.0||0.0002|TWO_SIDED|95.0|-23.3|-7.4||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-7.4|-23.3|0.0002
91689730|NCT01074944|183273572|NON_INFERIORITY_OR_EQUIVALENCE|Eliglustat QD treatment was declared non-inferior to BID treatment if the lower bound of the 95% confidence interval (CI) for the difference was within the non-inferiority margin of -0.15 (or -15%).|Difference in Percentage Stable|-2.7|||||TWO_SIDED|95.0|-17.7|11.9||||||||11.9|-17.7|
91689731|NCT03741400|183273622|OTHER|||||||0.88||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.88
91689732|NCT03741400|183273622|OTHER|||||||0.99||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.99
91689733|NCT03741400|183273622|OTHER|||||||0.8||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.80
91689734|NCT03741400|183273623|OTHER|||||||0.61||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.61
91689735|NCT03741400|183273624|OTHER|||||||0.47||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.47
91527129|NCT03445065|182929554|SUPERIORITY||Mean Difference (Net)|0.1||||0.859|TWO_SIDED|95.0|-0.6|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-0.6|0.859
91689736|NCT03741400|183273624|OTHER|||||||0.55||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.55
91689737|NCT03741400|183273624|OTHER|||||||0.38||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.38
91689738|NCT03741400|183273625|OTHER|||||||0.24||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.24
91689739|NCT03741400|183273626|OTHER|||||||0.18||||||A priori threshold for statistical significance, 0.05|Mann-Whitney U test|||||||0.18
91689740|NCT03741400|183273627|OTHER|||||||0.926||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 12||||0.926
91721673|NCT03074500|183335472|SUPERIORITY|||||||0.183||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.183
91527130|NCT03445065|182929554|SUPERIORITY||Mean Difference (Net)|-2.6||||0.01124|TWO_SIDED|95.0|-4.5|-0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.6|-4.5|0.01124
91689741|NCT03741400|183273627|OTHER|||||||0.828||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 24||||0.828
91689742|NCT02586155|183273646|SUPERIORITY||Cox Proportional Hazard|0.823||||0.107|TWO_SIDED|95.0|0.649|1.044|||Stratified long-rank|||||1.044|0.649|0.1070
91689743|NCT02586155|183273647|SUPERIORITY||Cox Proportional Hazard|0.849||||0.1495|TWO_SIDED|95.0|0.679|1.061|||Stratified long-rank|||||1.061|0.679|0.1495
91689744|NCT02586155|183273648|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.03|TWO_SIDED|95.0|0.38|0.94|||Stratified long-rank|||||0.94|0.38|0.03
91689745|NCT02586155|183273649|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.44|TWO_SIDED|95.0|0.62|1.24|||Stratified long-rank|||||1.24|0.62|0.44
91689746|NCT02586155|183273660|SUPERIORITY||Cox Proportional Hazard|0.78||||0.03|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.03
91689747|NCT02899962|183273700|SUPERIORITY|The primary endpoint was time to first relapse during the maintenance phase. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.|Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.47|0.69|||Regression, Cox||Estimates are obtained from a proportional hazards model with treatment group,pooled trial site,disease severity at maintenance baseline (Week 4; determined by PGA) as factors.|All randomized subjects were considered for statistical analysis.||0.69|0.47|<0.001
91689748|NCT02899962|183273701|SUPERIORITY||Mean Difference (Net)|0.11|||<|0.001|TWO_SIDED|95.0|0.08|0.14|||ANOVA|Factors adjusted for in the ANOVA model were treatment group, pooled trial site, and disease severity at maintenance baseline (PGA).|Multiple imputation of data for withdrawn subjects was done using 100 imputations and depended on whether the subject's reason for withdrawal potentially was related to treatment. Length of the maintenance phase was assumed to be 52 weeks (364 days)|The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.||0.14|0.08|<0.001
91721674|NCT03074500|183335472|SUPERIORITY|||||||0.719||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.719
91689749|NCT02899962|183273702|SUPERIORITY||Rate ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.46|0.63|||Poisson regression||The number of relapses was analysed using a Poisson regression model with treatment group,pooled sites,disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset.|||0.63|0.46|<0.001
91689750|NCT00473590|183273710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956||||0.9179|TWO_SIDED|95.0|0.404|2.261|||Log Rank|The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratios were estimated using Cox regression.|Stratified analysis||2.261|0.404|0.9179
91689751|NCT00473590|183273710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.6665|TWO_SIDED|95.0|0.369|1.893||The tests were exploratory because patients were not randomized to the two arms with respect to response status.|Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis.||1.893|0.369|0.6665
91689752|NCT00473590|183273711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.633||||0.3134|TWO_SIDED|95.0|0.258|1.552|||Log Rank||The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|Stratified analysis||1.552|0.258|0.3134
91689753|NCT00473590|183273711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2634|TWO_SIDED|95.0|0.251|1.468|||Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis||1.468|0.251|0.2634
91689754|NCT00473590|183273712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743||||0.2804|TWO_SIDED|95.0|0.432|1.276|||Log Rank|The analysis was stratified for number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.||1.276|0.432|0.2804
91721675|NCT03074500|183335472|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
91689755|NCT00473590|183273712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.713||||0.2009|TWO_SIDED|95.0|0.424|1.2|||Log Rank||Hazard ratio relative to BORT + P was estimated using Cox regression.|Unstratified Analysis.||1.200|0.424|0.2009
91689756|NCT02623725|183273733|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.33|2.06||||||Dengue Virus Serotype 1||2.06|1.33|
91689757|NCT02623725|183273733|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.82|||||TWO_SIDED|95.0|1.43|2.31||||||Dengue Virus Serotype 2||2.31|1.43|
91721676|NCT03074500|183335472|SUPERIORITY|||||||0.196||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.196
91721677|NCT03074500|183335472|SUPERIORITY|||||||0.318||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.318
91721678|NCT03074500|183335472|SUPERIORITY|||||||0.001|||||||Friedman's two-way analysis of variance|||||||0.001
91488699|NCT03685123|182849769|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91488700|NCT03685123|182849770|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91488701|NCT03685123|182849771|SUPERIORITY|||||||0.366|||||||Mixed Models Analysis|||||||0.366
91488702|NCT03685123|182849772|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91488703|NCT03685123|182849774|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91488704|NCT03685123|182849775|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91689758|NCT02623725|183273733|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.04|||||TWO_SIDED|95.0|0.841|1.27||||||Dengue Virus Serotype 3||1.27|0.841|
91689759|NCT02623725|183273733|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.32|||||TWO_SIDED|95.0|1.01|1.74||||||Dengue Virus Serotype 4||1.74|1.01|
91689760|NCT02623725|183273734|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.34|2.05||||||Dengue Virus Serotype 1||2.05|1.34|
91689761|NCT02623725|183273734|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.89|||||TWO_SIDED|95.0|1.49|2.41||||||Dengue Virus Serotype 2||2.41|1.49|
91721679|NCT03074500|183335472|SUPERIORITY|||||||0.483|||||||Friedman's two-way analysis of variance|||||||0.483
91689762|NCT02623725|183273734|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.06|||||TWO_SIDED|95.0|0.86|1.3||||||Dengue Virus Serotype 3||1.30|0.860|
91689763|NCT02623725|183273734|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.33|||||TWO_SIDED|95.0|1.02|1.73||||||Dengue Virus Serotype 4||1.73|1.02|
91689764|NCT03918629|183273747|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for geometric mean ratio (GMR) was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Adjusted geometric mean ratio (GMR) was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.90|0.74|
91689765|NCT03918629|183273747|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean difference in logarithmic scale.|Toxin B||0.66|0.49|
91689766|NCT03918629|183273748|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.8|||||TWO_SIDED|95.0|-6.4|2.9|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||2.9|-6.4|
91689767|NCT03918629|183273748|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-16.8|||||TWO_SIDED|95.0|-21.3|-12.2|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-12.2|-21.3|
91689768|NCT03918629|183273757|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.87|||||TWO_SIDED|95.0|0.8|0.95|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.95|0.80|
91689769|NCT03918629|183273757|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin B||0.81|0.62|
91689770|NCT03918629|183273758|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|1.7|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||1.7|-3.7|
91689771|NCT03918629|183273758|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-10.3|||||TWO_SIDED|95.0|-15.1|-5.5|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-5.5|-15.1|
91689772|NCT01243957|183273759|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.79|||||TWO_SIDED|90.0|1.61|2.0|||ANOVA|||||2.00|1.61|
91689773|NCT01243957|183273760|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.63|||||TWO_SIDED|90.0|1.49|1.79|||ANOVA|||||1.79|1.49|
91488705|NCT03685123|182849776|SUPERIORITY||||||<|0.001||||||General Health|Mixed Models Analysis|||||||<0.001
91488706|NCT03685123|182849776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health||||<0.001
91488707|NCT03685123|182849776|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||Role physical||||0.023
91689774|NCT01243957|183273761|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5459|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.5459
91488708|NCT03685123|182849776|SUPERIORITY||||||<|0.001||||||Bodily Pain|Mixed Models Analysis|||||||<0.001
91488709|NCT03685123|182849776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Vitality||||<0.001
91488710|NCT03685123|182849776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Social Functioning||||<0.001
91488711|NCT03685123|182849776|SUPERIORITY|||||||0.0105|||||||Mixed Models Analysis|||Mental Health||||0.0105
91488712|NCT03685123|182849776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Role Emotional||||<0.001
91488713|NCT03685123|182849776|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||SF-36 mental health Components (sum)||||0.01
91689775|NCT01243957|183273762|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.99|1.04|||ANOVA|||Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.||1.04|0.99|
91721680|NCT03074500|183335472|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
91721681|NCT03074500|183335473|SUPERIORITY|||||||0.897|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.897
91689776|NCT01243957|183273762|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.06|||ANOVA|||Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.||1.06|1.01|
91689777|NCT01243957|183273763|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||ANOVA|||Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684||1.03|0.97|
91689778|NCT01243957|183273763|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.||1.07|1.00|
91689779|NCT01243957|183273764|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.423|TWO_SIDED|90.0|-3.0|1.42|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.||1.42|-3.00|0.4230
91689780|NCT01243957|183273764|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.0293|TWO_SIDED|90.0|-6.5|-1.0|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.||-1.00|-6.50|0.0293
91689781|NCT01891864|183273765|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.|Risk Difference (RD)|-2.3|||||TWO_SIDED|95.0|-9.85|5.3||||||PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval \[-18%; 18%\]. A logistic regression model was to be employed.||5.3|-9.85|
91689782|NCT01891864|183273766|NON_INFERIORITY_OR_EQUIVALENCE|A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.64|||||TWO_SIDED|95.0|-3.474|2.204||||||||2.204|-3.474|
91689783|NCT01891864|183273766|NON_INFERIORITY_OR_EQUIVALENCE|The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-3.61|1.845||||||||1.845|-3.61|
91689784|NCT05620082|183273783|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91689785|NCT05620082|183273784|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91689786|NCT05620082|183273785|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91689787|NCT05620082|183273786|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Appearance of supplements||||0.10
91689788|NCT05620082|183273786|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Smell of supplements between groups||||0.10
91689789|NCT05620082|183273786|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparing Taste of supplements||||0.08
91689790|NCT05620082|183273786|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Comparing Sweetness of supplements||||0.70
91689791|NCT05620082|183273786|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparing Texture of supplements||||0.02
91488714|NCT03685123|182849776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health Components Sum||||<0.001
91689792|NCT05620082|183273786|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing Thickness of supplements||||0.45
91689793|NCT05620082|183273786|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Comparing Aftertaste of supplements||||0.25
91689794|NCT05620082|183273786|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Feeling in mouth' of supplements||||0.45
91689795|NCT05620082|183273786|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Future choice' of supplements||||0.06
91689796|NCT05620082|183273787|SUPERIORITY|||||||0.004||||||Pairwise comparisons with Bonferroni correction revealed a significant increase in total daily energy intake from baseline to porridge timepoints (p\<0.001).|Related samples Friedman's Two-Way ANOVA|||||||0.004
91689797|NCT03296813|183273805|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.765|TWO_SIDED|95.0|0.885|1.18||P-value not adjusted for multiple comparisons.|Regression, Cox|||To determine whether torsemide is superior to furosemide with respect to all-cause mortality among patients hospitalized for heart failure.|P-value from a Cox proportional hazards regression model including the assigned treatment (torsemide vs. furosemide as the reference group) as well as age, sex, baseline ejection fraction (\<40%, 41-49%, \>50%, unknown), and loop diuretic treatment prior to index hospital admission as covariates.|1.180|0.885|0.765
91689798|NCT03296813|183273806|SUPERIORITY||Hazard Ratio (HR)|0.918||||0.113|TWO_SIDED|95.0|0.826|1.02||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Regression, Cox|||To determine whether torsemide is superior to furosemide with respect to all-cause mortality or first all-cause hospitalization through month 12 among patients hospitalized for heart failure.|P-value from a Cox proportional hazards regression model including the assigned treatment (torsemide vs. furosemide as the reference group) as well as age, sex, baseline ejection fraction (\<40%, 41-49%, \>50%, unknown), and loop diuretic treatment prior to index hospital admission as covariates.|1.020|0.826|0.113
91721682|NCT03074500|183335473|SUPERIORITY|||||||0.325|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.325
91721683|NCT03074500|183335473|SUPERIORITY|||||||0.172|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.172
91721684|NCT03074500|183335473|SUPERIORITY|||||||0.622||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.622
91689799|NCT03296813|183273807|SUPERIORITY||Risk Ratio (RR)|0.945||||0.366|TWO_SIDED|95.0|0.836|1.068||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Regression, Linear|||To determine whether torsemide is superior to furosemide with respect to total all-cause hospitalizations through month 12 among patients hospitalized for heart failure.|P-value from a negative binomial regression of the frequency of re-hospitalizations with an offset term of the log of each subject's months to last re-hospitalization assessment through month 12. Re-hospitalizations greater than or equal to 5 were combined and analyzed with re-hospitalizations = 5 (i.e., one category \>=5) and for the subjects with \>=5 re-hospitalizations, the offset term was the log of the months to the 5th re-hospitalization.|1.068|0.836|0.366
91689800|NCT03296813|183273808|SUPERIORITY||Hazard Ratio (HR)|0.943||||0.61|TWO_SIDED|95.0|0.753|1.181||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Regression, Cox|||To determine whether torsemide is superior to furosemide with respect to all-cause mortality or first all-cause hospitalization through day 30 among patients hospitalized for heart failure.|P-value from a Cox proportional hazards regression model including the assigned treatment (torsemide vs. furosemide as the reference group) as well as age, sex, baseline ejection fraction (\<40%, 41-49%, \>50%, unknown), and loop diuretic treatment prior to index hospital admission as covariates.|1.181|0.753|0.610
91689801|NCT03296813|183273809|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.194|TWO_SIDED|95.0|-0.66|3.26||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Mixed Models Analysis|||To determine whether torsemide improves the QOL at 1 month compared to Furosemide as assessed by the KCCQ among patients hospitalized for heart failure.|Least squares means results from mixed-model repeated measures analysis of the KCCQ score change from baseline with terms for treatment, time (visit) from randomization, treatment x time (visit) interaction as well as the baseline KCCQ score, age, sex, baseline ejection fraction (\<40%, 41-49%, \>50%, unknown), and loop diuretic treatment prior to index hospital admission as covariates.|3.26|-0.66|0.194
91689802|NCT03296813|183273809|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.718|TWO_SIDED|95.0|-2.53|1.74||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Mixed Models Analysis|||To determine whether torsemide improves the QOL at 6 months compared to Furosemide as assessed by the KCCQ among patients hospitalized for heart failure.|Least squares means results from mixed-model repeated measures analysis of the KCCQ score change from baseline with terms for treatment, time (visit) from randomization, treatment x time (visit) interaction as well as the baseline KCCQ score, age, sex, baseline ejection fraction (\<40%, 41-49%, \>50%, unknown), and loop diuretic treatment prior to index hospital admission as covariates.|1.74|-2.53|0.718
91689803|NCT03296813|183273809|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.987|TWO_SIDED|95.0|-2.26|2.3||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Mixed Models Analysis|||To determine whether torsemide improves the QOL at 12 months compared to Furosemide as assessed by the KCCQ among patients hospitalized for heart failure.|Least squares means results from mixed-model repeated measures analysis of the KCCQ score change from baseline with terms for treatment, time (visit) from randomization, treatment x time (visit) interaction as well as the baseline KCCQ score, age, sex, baseline ejection fraction (\<40%, 41-49%, \>50%, unknown), and loop diuretic treatment prior to index hospital admission as covariates.|2.30|-2.26|0.987
91689804|NCT03296813|183273810|SUPERIORITY|||||||0.904||||||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Wilcoxon (Mann-Whitney)|||To determine whether torsemide reduces symptoms of depression at 1 month compared to Furosemide as assessed by the PHQ-2 among patients hospitalized for heart failure.||||0.904
91689805|NCT03296813|183273810|SUPERIORITY|||||||0.829||||||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Wilcoxon (Mann-Whitney)|||To determine whether torsemide reduces symptoms of depression at 6 months compared to Furosemide as assessed by the PHQ-2 among patients hospitalized for heart failure.||||0.829
91689806|NCT03296813|183273810|SUPERIORITY|||||||0.342||||||For secondary analyses, a statistically significant p-value \< 0.005 was pre-specified to address the multiple planned analyses and help control the overall type I error rate.|Wilcoxon (Mann-Whitney)|||To determine whether torsemide reduces symptoms of depression at 12 months compared to Furosemide as assessed by the PHQ-2 among patients hospitalized for heart failure.||||0.342
91689807|NCT02513160|183273811|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|150.0|||<|0.0001|TWO_SIDED|95.0|86.8|213.2||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||213.2|86.8|<0.0001
91721685|NCT03074500|183335473|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.909
91721686|NCT03074500|183335473|SUPERIORITY|||||||0.79||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.79
91488715|NCT03685123|182849777|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in kilocalories consumed from baseline to week 10||||<0.001
91488716|NCT03685123|182849778|SUPERIORITY|||||||0.658|||||||Mixed Models Analysis|||Change in LDL Particle Size||||0.658
91488717|NCT03685123|182849778|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||HDL participle size||||0.07
91689808|NCT02513160|183273811|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|144.0|||<|0.0001|TWO_SIDED|95.0|80.7|206.6||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||206.6|80.7|<0.0001
91689809|NCT02513160|183273811|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|148.0|||<|0.0001|TWO_SIDED|95.0|84.7|211.4||a priori threshold for significance of 0.05. The p-value was not adjusted.|ANCOVA|Difference of LS means and 95% CI represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|||211.4|84.7|<0.0001
91689810|NCT02513160|183273812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.9||||0.0003|TWO_SIDED|95.0|10.11|33.71||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Treatment comparisons began with am PEF for BAI 640 mcg/day vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BAI 640 mcg/day vs placebo 2) the am PEF for BAI 320 mcg/day vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||33.71|10.11|0.0003
91689811|NCT02513160|183273812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|30.1|||<|0.0001|TWO_SIDED|95.0|18.33|41.9||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in previous analysis.||41.90|18.33|<0.0001
91689812|NCT02513160|183273812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.0||||0.0006|TWO_SIDED|95.0|9.14|32.83||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||32.83|9.14|0.0006
91689813|NCT02513160|183273813|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|143.0|||<|0.0001|TWO_SIDED|95.0|71.7|214.1||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||214.1|71.7|<0.0001
91689814|NCT02513160|183273813|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|170.0|||<|0.0001|TWO_SIDED|95.0|98.5|240.5||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||240.5|98.5|<0.0001
91689815|NCT02513160|183273813|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|133.0||||0.0003|TWO_SIDED|95.0|61.3|204.3||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||204.3|61.3|0.0003
91689816|NCT02513160|183273814|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.408|-0.64||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.640|-1.408|<0.0001
91689817|NCT02513160|183273814|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.482|-0.717||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.717|-1.482|<0.0001
91689818|NCT02513160|183273814|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.415|-0.643||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.643|-1.415|<0.0001
91689819|NCT02513160|183273815|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.203||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.203|-0.440|<0.0001
91689820|NCT02513160|183273815|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.365|-0.128||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.128|-0.365|<0.0001
91721687|NCT03074500|183335473|SUPERIORITY|||||||0.24||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.24
91488718|NCT01254630|182849779|SUPERIORITY||Vaccine Efficacy|0.636|||||TWO_SIDED|97.5|0.364|0.791|||||Point estimate and 97.5% CI of vaccine efficacy (primary endpoint) were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 97.5% Confidence Interval (CI) be \>0.25.||0.791|0.364|
91488719|NCT01254630|182849780|OTHER||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-1.8|4.5||||||||4.5|-1.8|
91689821|NCT02513160|183273815|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.423|-0.185||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.185|-0.423|<0.0001
91689822|NCT02513160|183273816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|||||||Log Rank|||||||0.0058
91689823|NCT02513160|183273816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||Log Rank|||||||0.0014
91689824|NCT02513160|183273816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|||||||Log Rank|||||||0.0062
91689825|NCT02059512|183273824|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||||||0.24
91689826|NCT02059512|183273825|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of hospital stay.||||0.1
91689827|NCT02059512|183273825|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of stay in the intensive care unit.||||0.1
91689828|NCT02059512|183273826|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.4
91689829|NCT02059512|183273826|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Analysis of leukocytes 0-6 hours of the postoperative period.||||0.8
91689830|NCT02059512|183273826|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||Analysis of leukocytes 12-18 hours of the postoperative period.||||0.9
91689831|NCT02059512|183273826|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||Analysis of leukocytes 18-24 hours of the postoperative period.||||0.2
91689832|NCT02059512|183273826|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 48 hours of the postoperative period.||||0.5
91689833|NCT02059512|183273826|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 72 hours of the postoperative period.||||0.4
91689834|NCT02059512|183273826|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Analysis of leukocytes 96 hours of the postoperative period/||||0.6
91689835|NCT02059512|183273826|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 7 days of the postoperative period.||||0.4
91689836|NCT02059512|183273826|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 14 days of the postoperative period.||||0.5
91689837|NCT02059512|183273827|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||CRP initially.||||0.1
91689838|NCT02059512|183273827|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||CRP postoperative 4-6 days.||||0.4
91689839|NCT02059512|183273827|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||CRP postoperative 12-14 days.||||0.99
91689840|NCT02059512|183273828|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||The volume of discharge through the drains on the first day after surgery.||||0.2
91689841|NCT02059512|183273828|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||The volume of discharge through the drains on the second day after the operation.||||0.3
91689842|NCT02059512|183273829|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Troponin I postoperative day 1.||||0.6
91689843|NCT02059512|183273829|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Troponin I postoperative day 3.||||0.4
91689844|NCT02059512|183273829|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Myoglobin postoperative day 1.||||0.8
91689845|NCT02059512|183273829|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||Myoglobin postoperative day 3.||||0.7
91689846|NCT02059512|183273830|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||CPK-MB postoperative day 1.||||0.7
91689847|NCT02059512|183273830|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||CPK-MB postoperative day 3.||||0.8
91689848|NCT02059512|183273831|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Hb intraoperatively before turning off the cardiopulmonary bypass(CPB).||||1.0
91689849|NCT02059512|183273831|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Hb at the end of the operation.||||0.4
91689850|NCT02059512|183273832|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||HCT intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.8
91689851|NCT02059512|183273832|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||HCT at the end of the operation.||||0.3
91689852|NCT02059512|183273833|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||K+ intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.4
91689853|NCT02059512|183273833|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||K+ at the end of the operation.||||0.1
91689854|NCT02059512|183273834|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
91689855|NCT02059512|183273835|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
91689856|NCT02059512|183273836|SUPERIORITY|||||||0.6|||||||Chi-squared|||Hydrothorax / postoperative period.||||0.6
91689857|NCT02059512|183273836|SUPERIORITY|||||||0.2|||||||Chi-squared|||Hydropericardium / postoperative period.||||0.2
91689858|NCT02059512|183273836|SUPERIORITY|||||||0.6|||||||Chi-squared|||Resternotomy / postoperative period.||||0.6
91689859|NCT02059512|183273836|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial fibrillation / postoperative period.||||0.06
91689860|NCT02059512|183273836|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial flutter / postoperative period.||||0.06
91689861|NCT02059512|183273837|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||||||0.4
91689862|NCT02059512|183273838|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA kg / cm) - Evaluation of the left ventricular end-diastolic size index.||||0.5
91689863|NCT02059512|183273838|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - Evaluation of the left ventricular end-systolic size index.||||0.5
91689864|NCT02059512|183273838|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - Left Atrial Size Index Assessment.||||0.6
91689865|NCT02059512|183273839|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - Evaluation of the left ventricular end-diastolic volume index.||||0.4
91689866|NCT02059512|183273839|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||Evaluation of the left ventricular end-systolic volume index (LVESV MOD BP ind.)||||0.3
91689867|NCT02059512|183273840|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
91689868|NCT02059512|183273842|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Physical Functioning SF-36. Comparison of patients of group 1 and group 2 with the control group - group 0.||||0.7
91488720|NCT01254630|182849781|OTHER||Vaccine Efficacy|0.771|||||TWO_SIDED|95.0|0.48|0.899|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.899|0.480|
91488721|NCT01254630|182849782|OTHER||Vaccine Efficacy|0.874|||||TWO_SIDED|95.0|-0.005|0.984|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.984|-0.005|
91488722|NCT01254630|182849783|OTHER||Vaccine Efficacy|0.746|||||TWO_SIDED|95.0|-1.275|0.972|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.972|-1.275|
91527687|NCT01976364|182930494|OTHER||LS mean difference|0.93|||||TWO_SIDED|95.0|-0.95|2.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.81|-0.95|
91689869|NCT02059512|183273842|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Role-Physical Functioning SF-36||||0.8
91689870|NCT02059512|183273842|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Bodily pain SF-36||||0.7
91689871|NCT02059512|183273842|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||General Health SF-36.||||0.6
91689872|NCT02059512|183273842|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Vitality SF-36.||||0.8
91689873|NCT02059512|183273842|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Social Functioning SF-36.||||0.7
91689874|NCT02059512|183273842|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Role- Emotional SF-36.||||0.7
91689875|NCT02059512|183273842|SUPERIORITY|||||||0.96|||||||RepeatedMeasures ANOVA|||Mental Health SF-36.||||0.96
91689876|NCT02059512|183273842|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Minnesota Quality of Life (MHFLQ).||||0.7
91689877|NCT02059512|183273842|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||Seattle QuestionnairePhysical limitation.||||0.6
91689878|NCT02059512|183273842|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina stability.||||0.4
91689879|NCT02059512|183273842|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina frequency.||||0.6
91689880|NCT02059512|183273842|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireTreatment satisfaction.||||0.7
91689881|NCT02059512|183273842|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaire Disease perception.||||0.3
91689882|NCT02059512|183273843|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91689883|NCT02059512|183273844|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
91488723|NCT01254630|182849784|OTHER||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||||1.6|-0.6|
91488724|NCT02959983|182849785|SUPERIORITY|||||||0.0022|||||||Chi-squared|||Overall Weeks 1-12||||0.0022
91488725|NCT02959983|182849786|SUPERIORITY|||||||0.0119|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0119
91488726|NCT02959983|182849786|SUPERIORITY|||||||0.0048|||||||Chi-squared|||Weeks 1 to 4||||0.0048
91488727|NCT02959983|182849786|SUPERIORITY|||||||0.0207|||||||Chi-squared|||Weeks 5 to 8||||0.0207
91488728|NCT02959983|182849786|SUPERIORITY|||||||0.37|||||||Chi-squared|||Weeks 9 to 12||||0.3700
91488729|NCT02959983|182849787|SUPERIORITY|||||||0.0174|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0174
91488730|NCT02959983|182849787|SUPERIORITY|||||||0.3832|||||||Chi-squared|||Weeks 1 to 4||||0.3832
91488731|NCT02959983|182849787|SUPERIORITY|||||||0.0052|||||||Chi-squared|||Weeks 5 to 8||||0.0052
91689884|NCT02059512|183273845|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||||||0.35
91689885|NCT02059512|183273846|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA) - left ventricular end-diastolic size index. All patients included in the study.||||0.2
91689886|NCT02059512|183273846|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - left ventricular end-systolic size index.||||0.2
91689887|NCT02059512|183273846|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - left atrial index.||||0.5
91689888|NCT02059512|183273847|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - left ventricular end-diastolic volume index.||||0.6
91689889|NCT02059512|183273847|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||LVESV MOD BP ind. (LVESV MOD BP ml./BSA kg / cm) - left ventricular end-systolic volume index.||||0.2
91689890|NCT02059512|183273848|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow||||0.35
91689891|NCT02059512|183273848|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Peak A of transmitral flow.||||0.7
91689892|NCT02059512|183273849|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow/ Peak A of transmitral flow (E/A).||||0.5
91689893|NCT02059512|183273850|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||DT (Half-time of wave E).||||0.9
91689894|NCT02059512|183273850|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||time of isovolumic relaxation of the left ventricle||||0.9
91689895|NCT02059512|183273851|SUPERIORITY|||||||0.0367|||||||Kruskal-Wallis|||||||0.0367
91689896|NCT02059512|183273852|SUPERIORITY|||||||0.04|||||||Chi-squared|||Assessment of the functioning of grafts. Patency of grafts within a specified time of treatment (angiography).||||0.04
91689897|NCT02059512|183273853|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91488732|NCT02959983|182849787|SUPERIORITY|||||||0.0619|||||||Chi-squared|||Weeks 9 to 12||||0.0619
91689898|NCT02059512|183273854|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||||||0.05
91689899|NCT02059512|183273855|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||Mononuclear fraction %||||0.05
91689900|NCT02059512|183273855|SUPERIORITY|||||||0.057|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||CD34+ %||||0.057
91689901|NCT02059512|183273855|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||CD133+ %||||0.05
91689902|NCT02059512|183273856|SUPERIORITY|||||||0.046|||||||Factor analysis|||Factor analysis - determining the influence of a factor, in this case, smoking, on the deficit in the number of meters passed according to the test with a 6-minute walk.||||0.046
91488733|NCT02959983|182849788|SUPERIORITY|||||||0.033|||||||Chi-squared|||Weeks 1-4||||0.0330
91488734|NCT02959983|182849788|SUPERIORITY|||||||0.0063|||||||Chi-squared|||Weeks 5 to 8||||0.0063
91488735|NCT02959983|182849788|SUPERIORITY|||||||0.0018|||||||Chi-squared|||Weeks 9 to 12||||0.0018
91488736|NCT03221270|182849789|SUPERIORITY|alternative hypothesis: true difference in means is greater than 0|Median Difference (Final Values)|-0.43||||0.66|ONE_SIDED|95.0|-2.25||||t-test, 1 sided||||||-2.25|0.66
91488737|NCT03439657|182849800|NON_INFERIORITY|Upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies Geometric Mean Concentration (GMC) ratio between the Control group and the Co-Ad group should be \<1.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.99|1.16|||ANCOVA|The 95% CI of the group GMCs ratio was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-gE GMCs (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.||1.16|0.99|
91689903|NCT00803790|183273857|SUPERIORITY_OR_OTHER_LEGACY||least square mean ratio|1.01|||||TWO_SIDED|90.0|0.92|1.11||||||||1.11|0.92|
91689904|NCT00803790|183273858|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||Least squares mean ratio for AUC 0-80 hr for vitamin D following administration of combination tablet and vitamin D alone. No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis.||1.00|0.89|
91689905|NCT00803790|183273859|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||"Least squares mean ratio for Cmax for vitamin D following administration of combination tablet and vitamin D alone.~No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis."||1.00|0.88|
91689906|NCT04581824|183273880|OTHER||Difference in Response Rate|9.32|||||TWO_SIDED|80.0|1.46|17.18|||||Mantel and Haenszel method with Sato's variance estimator was used for between arms comparison and was stratified by PD-L1 status and smoking status based on the strata data collected in interactive response technology (IRT) at randomization|||17.18|1.46|
91689907|NCT03593473|183273887|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -40 minutes.||||0.37
91689908|NCT03593473|183273887|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -20 minutes.||||0.40
91689909|NCT03593473|183273887|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 0 minutes.||||0.63
91689910|NCT03593473|183273887|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 10 minutes.||||0.72
91689911|NCT03593473|183273887|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 15 minutes.||||0.88
91689912|NCT03593473|183273887|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 28 minutes.||||0.85
91689913|NCT03593473|183273887|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 38 minutes.||||0.72
91689914|NCT03593473|183273887|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 48 minutes.||||0.57
91689915|NCT03593473|183273887|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. Times are restricted to times 0, +10, +15, and +28, which reflect the measures taken during the Trier Social Stress Test. The p-value presented below is for the interaction term between time and study arm.||||0.96
91689916|NCT03593473|183273888|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -40 minutes.||||0.71
91689917|NCT03593473|183273888|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -20 minutes.||||0.92
91488738|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.||1.33|0.82|
91488739|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.86|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.86|
91488740|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.02|1.52|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.||1.52|1.02|
91488741|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.81|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.81|
91689918|NCT03593473|183273888|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 0 minutes.||||0.92
91689919|NCT03593473|183273888|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 10 minutes.||||0.40
91689920|NCT03593473|183273888|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 15 minutes.||||0.97
91689921|NCT03593473|183273888|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 28 minutes.||||0.71
91689922|NCT03593473|183273888|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 38 minutes.||||0.78
91689923|NCT03593473|183273888|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 48 minutes.||||0.63
91527131|NCT03445065|182929555|SUPERIORITY||Mean Difference (Net)|-0.802|STANDARD_ERROR_OF_MEAN|0.391||0.045|TWO_SIDED|95.0|-1.1585|-0.018||The significance level was set to p\<0.05 (two-sided).|Mixed Models Analysis|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled (D150-180) group minus the Enabled (D90-120) group.|||-0.018|-1.1585|0.045
91527132|NCT03445065|182929556|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.54||0.763|TWO_SIDED|95.0|-2.741|3.682||The significance level was set to p\<0.05 (two-sided).|Mixed Model for Repeated Measures|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Switch to Enabled (D150-180) group minus the Control (D90-120) group.|||3.682|-2.741|0.763
91689924|NCT03593473|183273888|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. This is the p-value for the interaction term between time and study arm.||||0.11
91689925|NCT03593473|183273889|SUPERIORITY|||||||0.07|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -40 minutes and Cortisol at -20 minutes.||||0.07
91689926|NCT03593473|183273889|SUPERIORITY|||||||0.22|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -20 minutes and Cortisol at 0 minutes.||||0.22
91689927|NCT03593473|183273889|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at 0 minutes and Cortisol at +10 minutes.||||0.14
91689928|NCT03593473|183273889|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +10 minutes and Cortisol at +15 minutes.||||0.14
91689929|NCT03593473|183273889|SUPERIORITY|||||||0.05|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +15 minutes and Cortisol at +28 minutes.||||0.05
91689930|NCT03593473|183273889|SUPERIORITY|||||||0.1|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +28 minutes and Cortisol at +38 minutes.||||0.10
91689931|NCT03593473|183273889|SUPERIORITY|||||||0.9|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +38 minutes and Cortisol at +48 minutes.||||0.90
91689932|NCT03593473|183273889|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol at time j+1 as the outcome with ACTH at time j, study arm, and an interaction term between ACTH at time j and study arm as the exposure variables. The p-value presented below is for the interaction term between ACTH at time j and study arm.||||0.21
91689933|NCT03593473|183273890|SUPERIORITY|||||||0.8441|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -40 to -35||||0.8441
91689934|NCT03593473|183273890|SUPERIORITY|||||||0.7919|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -35 to -30||||0.7919
91689935|NCT03593473|183273890|SUPERIORITY|||||||0.5639|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -30 to -25||||0.5639
91689936|NCT03593473|183273890|SUPERIORITY|||||||0.3139|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -25 to -20||||0.3139
91689937|NCT03593473|183273890|SUPERIORITY|||||||0.4222|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -20 to -15||||0.4222
91689938|NCT03593473|183273890|SUPERIORITY|||||||0.834|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -15 to -10||||0.834
91689939|NCT03593473|183273890|SUPERIORITY|||||||0.7562|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -10 to -5||||0.7562
91689940|NCT03593473|183273890|SUPERIORITY|||||||0.4245|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -5 to 0||||0.4245
91689941|NCT03593473|183273890|SUPERIORITY|||||||0.1425|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 5 to 8||||0.1425
91689942|NCT03593473|183273890|SUPERIORITY|||||||0.7175|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 13||||0.7175
91689943|NCT03593473|183273890|SUPERIORITY|||||||0.1417|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 13 to 18||||0.1417
91689944|NCT03593473|183273890|SUPERIORITY|||||||0.0514|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 18 to 23||||0.0514
91689945|NCT03593473|183273890|SUPERIORITY|||||||0.1507|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 23 to 28||||0.1507
91689946|NCT03593473|183273890|SUPERIORITY|||||||0.4204|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 33||||0.4204
91689947|NCT03593473|183273890|SUPERIORITY|||||||0.4209|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 33 to 38||||0.4209
91689948|NCT03593473|183273890|SUPERIORITY|||||||0.2569|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 38 to 43||||0.2569
91689949|NCT03593473|183273890|SUPERIORITY|||||||0.0828|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 43 to 48||||0.0828
91689950|NCT03593473|183273891|SUPERIORITY|||||||0.6452|||||||t-test, 2 sided|||Pre-ejection period at minutes -40 to -35||||0.6452
91689951|NCT03593473|183273891|SUPERIORITY|||||||0.3228|||||||t-test, 2 sided|||Pre-ejection period at minutes -35 to -30||||0.3228
91689952|NCT03593473|183273891|SUPERIORITY|||||||0.3541|||||||t-test, 2 sided|||Pre-ejection period at minutes -30 to -25||||0.3541
91689953|NCT03593473|183273891|SUPERIORITY|||||||0.4311|||||||t-test, 2 sided|||Pre-ejection period at minutes -25 to -20||||0.4311
91689954|NCT03593473|183273891|SUPERIORITY|||||||0.3349|||||||t-test, 2 sided|||Pre-ejection period at minutes -20 to -15||||0.3349
91689955|NCT03593473|183273891|SUPERIORITY|||||||0.2646|||||||t-test, 2 sided|||Pre-ejection period at minutes -15 to -10||||0.2646
91689956|NCT03593473|183273891|SUPERIORITY|||||||0.1095|||||||t-test, 2 sided|||Pre-ejection period at minutes -10 to -5||||0.1095
91689957|NCT03593473|183273891|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Pre-ejection period at minutes -5 to 0||||0.0194
91689958|NCT03593473|183273891|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||Pre-ejection period at minutes 5 to 8||||0.473
91689959|NCT03593473|183273891|SUPERIORITY|||||||0.5768|||||||t-test, 2 sided|||Pre-ejection period at minutes 8 to 13||||0.5768
91689960|NCT03593473|183273891|SUPERIORITY|||||||0.3477|||||||t-test, 2 sided|||Pre-ejection period at minutes 13 to 18||||0.3477
91689961|NCT03593473|183273891|SUPERIORITY|||||||0.1413|||||||t-test, 2 sided|||Pre-ejection period at minutes 18 to 23||||0.1413
91689962|NCT03593473|183273891|SUPERIORITY|||||||0.2128|||||||t-test, 2 sided|||Pre-ejection period at minutes 23 to 28||||0.2128
91689963|NCT03593473|183273891|SUPERIORITY|||||||0.1415|||||||t-test, 2 sided|||Pre-ejection period at minutes 28 to 33||||0.1415
91689964|NCT03593473|183273891|SUPERIORITY|||||||0.1126|||||||t-test, 2 sided|||Pre-ejection period at minutes 33 to 38||||0.1126
91689965|NCT03593473|183273891|SUPERIORITY|||||||0.1647|||||||t-test, 2 sided|||Pre-ejection period at minutes 38 to 43||||0.1647
91689966|NCT03593473|183273891|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||Pre-ejection period at minutes 43 to 48||||0.088
91689967|NCT00813150|183273904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||Null Hypothesis: The (median) time to progression is equal in both treatment groups||1.19|0.43|0.196
91689968|NCT00813150|183273905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||||1.19|0.43|0.196
91689969|NCT00813150|183273906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.645|TWO_SIDED|95.0|0.41|1.73|||Regression, Cox|||||1.73|0.41|0.645
91689970|NCT00813150|183273907|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
91689971|NCT05085834|183273908|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.01|TWO_SIDED|95.0|0.43|0.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zinc, μg/dL)||0.98|0.43|<0.01
91689972|NCT05085834|183273909|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.002|STANDARD_ERROR_OF_MEAN|0.29||1|TWO_SIDED|95.0|-0.57|0.57|||linear combination of coefficients|||effect of Zinc supplementation on ln(hsCRP ng/mL)||0.57|-0.57|1.00
91689973|NCT05085834|183273909|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.08|TWO_SIDED|95.0|-0.18|0.01|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD14, ng/mL)||0.01|-0.18|0.08
91689974|NCT05085834|183273909|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.77|TWO_SIDED|95.0|-0.21|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD163, ng/mL)||0.15|-0.21|0.77
91689975|NCT05085834|183273909|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.19|TWO_SIDED|95.0|-0.1|0.5|||linear combination of coefficients|||effect of Zinc supplementation on ln(D-dimer, ng/mL)||0.50|-0.10|0.19
91689976|NCT05085834|183273909|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1|TWO_SIDED|95.0|-0.41|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(VCAM, ng/mL)||0.04|-0.41|0.10
91689977|NCT05085834|183273909|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.41|STANDARD_ERROR_OF_MEAN|20.19||0.98|TWO_SIDED|95.0|-39.16|39.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(ICAM, ng/mL)||39.98|-39.16|0.98
91689978|NCT05085834|183273910|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.55|TWO_SIDED|95.0|-0.09|0.16|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RI , pg/mL)||0.16|-0.09|0.55
91689979|NCT05085834|183273910|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.004|STANDARD_ERROR_OF_MEAN|0.07||0.95|TWO_SIDED|95.0|-0.13|0.13|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RII, pg/m)||0.13|-0.13|0.95
91689980|NCT05085834|183273910|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.19||0.73|TWO_SIDED|95.0|-0.3|0.43|||linear combination of coefficients|||effect of Zinc supplementation on ln(IL-6, pg/mL)||0.43|-0.30|0.73
91689981|NCT05085834|183273910|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.12|STANDARD_ERROR_OF_MEAN|0.18||0.48|TWO_SIDED|95.0|-0.22|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(IP-10, pg/mL)||0.47|-0.22|0.48
91689982|NCT05085834|183273911|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|1819.18|STANDARD_ERROR_OF_MEAN|8530.03||0.83|TWO_SIDED|95.0|-14899.37|18537.74|||linear combination of coefficients|||effect of Zinc supplementation on ln(OxLDL, U/L)||18537.74|-14899.37|0.83
91689983|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.84|TWO_SIDED|95.0|-0.12|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(Non-HDL Cholesterol (mg/dL))||0.15|-0.12|0.84
91689984|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.18|TWO_SIDED|95.0|-0.19|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(HDL (mg/dL))||0.04|-0.19|0.18
91689985|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.84|TWO_SIDED|95.0|-0.19|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(LDL (mg/dL))||0.15|-0.19|0.84
91721688|NCT03074500|183335473|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
91488742|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.26|||||TWO_SIDED|95.0|1.02|1.56|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.||1.56|1.02|
91689986|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.55|TWO_SIDED|95.0|-0.15|0.29|||linear combination of coefficients|||effect of Zinc supplementation on ln(VLDL (mg/dL))||0.29|-0.15|0.55
91689987|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.78|TWO_SIDED|95.0|-0.11|0.09|||linear combination of coefficients|||effect of Zinc supplementation on ln(Cholesterol (mg/dl))||0.09|-0.11|0.78
91689988|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.58|TWO_SIDED|95.0|-0.17|0.31|||linear combination of coefficients|||effect of Zinc supplementation on ln(Triglycerides (mg/dL))||0.31|-0.17|0.58
91689989|NCT05085834|183273912|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.44|STANDARD_ERROR_OF_MEAN|0.47||0.35|TWO_SIDED|95.0|-1.36|0.48|||linear combination of coefficients|||effect of Zinc supplementation on Metabolic Syndrome||0.48|-1.36|0.35
91689990|NCT05085834|183273913|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.07||0.36|TWO_SIDED|95.0|-0.07|0.2|||linear combination of coefficients|||effect of Zinc supplementation on ln(Chol:HDL Ratio)||0.20|-0.07|0.36
91689991|NCT05085834|183273914|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.35|STANDARD_ERROR_OF_MEAN|2.01||0.86|TWO_SIDED|95.0|-4.29|3.6|||linear combination of coefficients|||effect of Zinc supplementation on BMI (kg/m2)||3.60|-4.29|0.86
91689992|NCT05085834|183273915|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.74|TWO_SIDED|95.0|-0.08|0.05|||linear combination of coefficients|||effect of Zinc supplementation on ln(Waist-umbilicus (cm))||0.05|-0.08|0.74
91689993|NCT05085834|183273916|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-2.99|STANDARD_ERROR_OF_MEAN|12.23||0.81|TWO_SIDED|95.0|-26.97|20.99|||linear combination of coefficients|||effect of Zinc supplementation on Weight (lbs)||20.99|-26.97|0.81
91689994|NCT05085834|183273917|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.07|0.03|||linear combination of coefficients|||effect of Zinc supplementation on ln(Systolic blood pressure (mmHg))||0.03|-0.07|0.41
91689995|NCT05085834|183273917|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-1.68|STANDARD_ERROR_OF_MEAN|2.06||0.42|TWO_SIDED|95.0|-5.71|2.36|||linear combination of coeff|||effect of Zinc supplementation on Diastolic blood pressure (mmHg)||2.36|-5.71|0.42
91689996|NCT05085834|183273918|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7|TWO_SIDED|95.0|-0.26|0.17|||linear combination of coefficients|||effect of Zinc supplementation on ln(10 year ASCVD (%))||0.17|-0.26|0.70
91689997|NCT05085834|183273919|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.62|TWO_SIDED|95.0|-0.17|0.1|||linear combination of coefficients|||effect of Zinc supplementation on Reactive Hyperemic Index||0.10|-0.17|0.62
91689998|NCT05085834|183273919|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.59|STANDARD_ERROR_OF_MEAN|2.43||0.81|TWO_SIDED|95.0|-4.19|5.36|||linear combination of coefficients|||effect of Zinc supplementation on Augmentation Index||5.36|-4.19|0.81
91721689|NCT03074500|183335473|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.909
91689999|NCT05085834|183273920|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9|TWO_SIDED|95.0|-0.26|0.3|||linear combination of coefficients|||effect of Zinc supplementation on ln(IFAB (pg/mL))||0.30|-0.26|0.90
91690000|NCT05085834|183273920|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.18|STANDARD_ERROR_OF_MEAN|0.15||0.24|TWO_SIDED|95.0|-0.12|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(BDG (pg/mL))||0.47|-0.12|0.24
91690001|NCT05085834|183273921|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.69|TWO_SIDED|95.0|-0.21|0.32|||v|||effect of Zinc supplementation on ln(LBP (ng/mL))||0.32|-0.21|0.69
91690002|NCT05085834|183273921|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.49|TWO_SIDED|95.0|-0.16|0.34|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zonulin (ng/mL)||0.34|-0.16|0.49
91690003|NCT01662635|183273932|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student's t test. The x2 or Fisher's exact tests were used to assess significance among categorical variables.||||< 0.05
91690004|NCT01217112|183273933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.044||0.766|TWO_SIDED|90.0|-0.09|0.06|||ANCOVA|||Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.09|0.766
91690005|NCT01217112|183273933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.043||0.424|TWO_SIDED|90.0|-0.04|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.04|0.424
91690006|NCT01217112|183273933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.041||0.412|TWO_SIDED|90.0|-0.1|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.10|0.412
91690007|NCT01217112|183273933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.668|TWO_SIDED|90.0|-0.05|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.05|0.668
91690008|NCT01217112|183273934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.046||0.978|TWO_SIDED|90.0|-0.08|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.08|0.978
91690009|NCT01217112|183273934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.045||0.864|TWO_SIDED|90.0|-0.08|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.08|0.864
91690010|NCT01217112|183273934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.537|TWO_SIDED|90.0|-0.12|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-0.12|0.537
91690011|NCT01217112|183273934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.045||0.26|TWO_SIDED|90.0|-0.02|0.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.13|-0.02|0.260
91690012|NCT01217112|183273935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.088|TWO_SIDED|90.0|-0.61|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.61|0.088
91690013|NCT01217112|183273935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.177||0.583|TWO_SIDED|90.0|-0.2|0.39|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.39|-0.20|0.583
91721690|NCT03074500|183335473|SUPERIORITY|||||||0.255||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.255
91527688|NCT01976364|182930494|OTHER||LS mean difference|0.11|||||TWO_SIDED|95.0|-1.72|1.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.95|-1.72|
91690014|NCT01217112|183273935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.388|TWO_SIDED|90.0|-0.14|0.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.43|-0.14|0.388
91690015|NCT01217112|183273935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.58|TWO_SIDED|90.0|-0.19|0.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.38|-0.19|0.580
91690016|NCT01217112|183273936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.198||0.829|TWO_SIDED|90.0|-0.29|0.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.37|-0.29|0.829
91690017|NCT01217112|183273936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.196||0.575|TWO_SIDED|90.0|-0.22|0.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.44|-0.22|0.575
91690018|NCT01217112|183273936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.203||0.356|TWO_SIDED|90.0|-0.15|0.53|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.53|-0.15|0.356
91690019|NCT01217112|183273936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.188||0.472|TWO_SIDED|90.0|-0.18|0.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.45|-0.18|0.472
91690020|NCT01217112|183273937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.181||0.115|TWO_SIDED|90.0|-0.59|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.59|0.115
91690021|NCT01217112|183273937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.177||0.782|TWO_SIDED|90.0|-0.25|0.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.35|-0.25|0.782
91690022|NCT01217112|183273937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.173||0.902|TWO_SIDED|90.0|-0.27|0.31|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.31|-0.27|0.902
91690023|NCT01217112|183273937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.166||0.993|TWO_SIDED|90.0|-0.28|0.28|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.28|-0.28|0.993
91690024|NCT01217112|183273938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.143||0.956|TWO_SIDED|90.0|-0.23|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.23|0.956
91690025|NCT01217112|183273938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.144||0.705|TWO_SIDED|90.0|-0.19|0.3|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.30|-0.19|0.705
91690026|NCT01217112|183273938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.148||0.466|TWO_SIDED|90.0|-0.14|0.36|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.36|-0.14|0.466
91690027|NCT01217112|183273938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.136||0.876|TWO_SIDED|90.0|-0.21|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.21|0.876
91690028|NCT01217112|183273939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.034||0.408|TWO_SIDED|90.0|-0.03|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.03|0.408
91690029|NCT01217112|183273939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.714|TWO_SIDED|90.0|-0.04|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.04|0.714
91690030|NCT01217112|183273939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.032||0.267|TWO_SIDED|90.0|-0.09|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.09|0.267
91690031|NCT01217112|183273939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.032||0.484|TWO_SIDED|90.0|-0.03|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.03|0.484
91721691|NCT03074500|183335473|SUPERIORITY|||||||0.058||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.058
91690032|NCT01217112|183273940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.039||0.56|TWO_SIDED|90.0|-0.09|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.09|0.560
91690033|NCT01217112|183273940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.037||0.956|TWO_SIDED|90.0|-0.06|0.06|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.06|0.956
91690034|NCT01217112|183273940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.039||0.403|TWO_SIDED|90.0|-0.1|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.10|0.403
91690035|NCT01217112|183273940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.617|TWO_SIDED|90.0|-0.04|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.04|0.617
91690036|NCT01217112|183273941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.108||0.815|TWO_SIDED|90.0|-0.16|0.21|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.21|-0.16|0.815
91690037|NCT01217112|183273941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.105||0.418|TWO_SIDED|90.0|-0.09|0.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.26|-0.09|0.418
91690038|NCT01217112|183273941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.111||0.236|TWO_SIDED|90.0|-0.05|0.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.32|-0.05|0.236
91690039|NCT01217112|183273941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.103||0.556|TWO_SIDED|90.0|-0.11|0.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.23|-0.11|0.556
91690040|NCT01217112|183273942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.241||0.329|TWO_SIDED|90.0|-0.64|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.64|0.329
91690041|NCT01217112|183273942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.236||0.232|TWO_SIDED|90.0|-0.11|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.11|0.232
91690042|NCT01217112|183273942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.222||0.164|TWO_SIDED|90.0|-0.06|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.06|0.164
91690043|NCT01217112|183273942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.232||0.302|TWO_SIDED|90.0|-0.15|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-0.15|0.302
91690044|NCT01217112|183273943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.614|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.614
91690045|NCT01217112|183273943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.227||0.669|TWO_SIDED|90.0|-0.28|0.48|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.48|-0.28|0.669
91690046|NCT01217112|183273943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.24||0.621|TWO_SIDED|90.0|-0.28|0.52|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.52|-0.28|0.621
91690047|NCT01217112|183273943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.222||0.867|TWO_SIDED|90.0|-0.33|0.41|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.41|-0.33|0.867
91690048|NCT01217112|183273944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|2.624||0.335|TWO_SIDED|90.0|-1.84|6.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.95|-1.84|0.335
91690049|NCT01217112|183273944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.36|STANDARD_ERROR_OF_MEAN|2.545||0.358|TWO_SIDED|90.0|-1.9|6.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.62|-1.90|0.358
91721692|NCT03074500|183335473|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
91690050|NCT01217112|183273944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.406||0.9|TWO_SIDED|90.0|-3.72|4.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.33|-3.72|0.900
91690051|NCT01217112|183273944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|2.486||0.019|TWO_SIDED|90.0|1.86|10.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.19|1.86|0.019
91690052|NCT01217112|183273945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.245||0.325|TWO_SIDED|90.0|-0.65|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.65|0.325
91690053|NCT01217112|183273945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.238||0.438|TWO_SIDED|90.0|-0.21|0.59|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.59|-0.21|0.438
91690054|NCT01217112|183273945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.226||0.701|TWO_SIDED|90.0|-0.29|0.47|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.47|-0.29|0.701
91690055|NCT01217112|183273945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.232||0.624|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.624
91690056|NCT01217112|183273946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.058||0.233|TWO_SIDED|90.0|-0.17|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.17|0.233
91690057|NCT01217112|183273946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.056||0.727|TWO_SIDED|90.0|-0.07|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.07|0.727
91690058|NCT01217112|183273946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.593|TWO_SIDED|90.0|-0.06|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.06|0.593
91690059|NCT01217112|183273946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.075|TWO_SIDED|90.0|-0.2|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.20|0.075
91690060|NCT01217112|183273947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.084||0.236|TWO_SIDED|90.0|-0.04|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.04|0.236
91690061|NCT01217112|183273947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.082||0.579|TWO_SIDED|90.0|-0.09|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.09|0.579
91690062|NCT01217112|183273947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.077||0.837|TWO_SIDED|90.0|-0.15|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.15|0.837
91721693|NCT03074500|183335473|SUPERIORITY|||||||0.007|||||||Friedman's two-way analysis of variance|||||||0.007
91721694|NCT03074500|183335473|SUPERIORITY|||||||0.614|||||||Friedman's two-way analysis of variance|||||||0.614
91690063|NCT01217112|183273947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.467|TWO_SIDED|90.0|-0.08|0.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.19|-0.08|0.467
91690064|NCT01217112|183273948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.613||0.533|TWO_SIDED|90.0|-1.41|0.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.64|-1.41|0.533
91690065|NCT01217112|183273948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.585||0.804|TWO_SIDED|90.0|-0.84|1.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.13|-0.84|0.804
91721695|NCT03074500|183335473|SUPERIORITY|||||||0.072|||||||Friedman's two-way analysis of variance|||||||0.072
91721696|NCT03074500|183335473|SUPERIORITY|||||||0.447|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.447
91721697|NCT03074500|183335473|SUPERIORITY|||||||0.084|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.084
91721698|NCT03074500|183335473|SUPERIORITY|||||||0.235|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.235
91721699|NCT03074500|183335474|SUPERIORITY|||||||0.958|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.958
91721700|NCT03074500|183335474|SUPERIORITY|||||||0.597|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.597
91690066|NCT01217112|183273948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.556||0.916|TWO_SIDED|90.0|-0.87|0.99|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.99|-0.87|0.916
91690067|NCT01217112|183273948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.583||0.04|TWO_SIDED|90.0|-2.2|-0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.25|-2.20|0.040
91690068|NCT01217112|183273949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|10.838||0.366|TWO_SIDED|90.0|-28.06|8.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||8.27|-28.06|0.366
91690069|NCT01217112|183273949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|10.692||0.844|TWO_SIDED|90.0|-15.81|20.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||20.03|-15.81|0.844
91690070|NCT01217112|183273949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.96|STANDARD_ERROR_OF_MEAN|10.026||0.118|TWO_SIDED|90.0|-32.76|0.84|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.84|-32.76|0.118
91690071|NCT01217112|183273949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|10.256||0.518|TWO_SIDED|90.0|-23.86|10.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.51|-23.86|0.518
91690072|NCT01217112|183273950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.294||0.576|TWO_SIDED|90.0|-0.66|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-0.66|0.576
91690073|NCT01217112|183273950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.283||0.648|TWO_SIDED|90.0|-0.6|0.34|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.34|-0.60|0.648
91690074|NCT01217112|183273950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.269||0.447|TWO_SIDED|90.0|-0.66|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.66|0.447
91690075|NCT01217112|183273950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.283||0.273|TWO_SIDED|90.0|-0.79|0.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.16|-0.79|0.273
91690076|NCT01217112|183273951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.097||0.615|TWO_SIDED|90.0|-2.4|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-2.40|0.615
91690077|NCT01217112|183273951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.973||0.342|TWO_SIDED|90.0|-0.7|2.57|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.57|-0.70|0.342
91690078|NCT01217112|183273951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.934||0.314|TWO_SIDED|90.0|-2.52|0.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.62|-2.52|0.314
91690079|NCT01217112|183273951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.964||0.889|TWO_SIDED|90.0|-1.48|1.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.75|-1.48|0.889
91690080|NCT01217112|183273952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.89|STANDARD_ERROR_OF_MEAN|168.459||0.764|TWO_SIDED|90.0|-232.02|333.8|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||333.80|-232.02|0.764
91690081|NCT01217112|183273952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|156.72||0.654|TWO_SIDED|90.0|-333.96|192.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||192.44|-333.96|0.654
91690082|NCT01217112|183273952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-111.5|STANDARD_ERROR_OF_MEAN|146.276||0.45|TWO_SIDED|90.0|-357.17|134.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||134.16|-357.17|0.450
91721701|NCT03074500|183335474|SUPERIORITY|||||||0.518|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.518
91721702|NCT03074500|183335474|SUPERIORITY|||||||0.88||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.88
91721703|NCT03074500|183335474|SUPERIORITY|||||||0.733||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.733
91690083|NCT01217112|183273952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|97.42|STANDARD_ERROR_OF_MEAN|149.124||0.517|TWO_SIDED|90.0|-153.02|347.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||347.86|-153.02|0.517
91690084|NCT01217112|183273953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|40.94||0.84|TWO_SIDED|90.0|-60.28|76.94|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||76.94|-60.28|0.840
91690085|NCT01217112|183273953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|39.521||0.834|TWO_SIDED|90.0|-57.92|74.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||74.55|-57.92|0.834
91690086|NCT01217112|183273953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.62|STANDARD_ERROR_OF_MEAN|39.044||0.767|TWO_SIDED|90.0|-77.06|53.81|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||53.81|-77.06|0.767
91690087|NCT01217112|183273953|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.51|STANDARD_ERROR_OF_MEAN|39.68||0.289|TWO_SIDED|90.0|-23.99|109.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||109.01|-23.99|0.289
91690088|NCT01217112|183273954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.106||0.569|TWO_SIDED|90.0|-0.24|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.24|0.569
91690089|NCT01217112|183273954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.101||0.984|TWO_SIDED|90.0|-0.17|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.17|0.984
91690090|NCT01217112|183273954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.098||0.176|TWO_SIDED|90.0|-0.3|0.03|||ANCOVA|||v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.30|0.176
91690091|NCT01217112|183273954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.099||0.895|TWO_SIDED|90.0|-0.15|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.15|0.895
91690092|NCT01217112|183273955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.745||0.871|TWO_SIDED|90.0|-1.13|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.13|0.871
91690093|NCT01217112|183273955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.721||0.826|TWO_SIDED|90.0|-1.05|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.05|0.826
91690094|NCT01217112|183273955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.703||0.693|TWO_SIDED|90.0|-1.46|0.9|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.90|-1.46|0.693
91690095|NCT01217112|183273955|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.722||0.536|TWO_SIDED|90.0|-0.76|1.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.66|-0.76|0.536
91690096|NCT01217112|183273956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|8.633||0.878|TWO_SIDED|90.0|-15.8|13.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||13.13|-15.80|0.878
91690097|NCT01217112|183273956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|8.377||0.919|TWO_SIDED|90.0|-13.18|14.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||14.89|-13.18|0.919
91690098|NCT01217112|183273956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.72|STANDARD_ERROR_OF_MEAN|7.989||0.557|TWO_SIDED|90.0|-8.67|18.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||18.11|-8.67|0.557
91690099|NCT01217112|183273956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|8.328||0.275|TWO_SIDED|90.0|-4.76|23.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||23.16|-4.76|0.275
91690100|NCT01217112|183273957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|16.445||0.528|TWO_SIDED|90.0|-17.12|38.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||38.01|-17.12|0.528
91488743|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.07|1.73|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.||1.73|1.07|
91488744|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.21|||||TWO_SIDED|95.0|1.01|1.44|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.||1.44|1.01|
91527133|NCT03445065|182929557|SUPERIORITY||Mean Difference (Net)|1.3||||0.14|TWO_SIDED|95.0|-0.4|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-0.4|0.140
91690101|NCT01217112|183273957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|15.825||0.99|TWO_SIDED|90.0|-26.32|26.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||26.72|-26.32|0.990
91690102|NCT01217112|183273957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|15.369||0.776|TWO_SIDED|90.0|-21.37|30.15|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||30.15|-21.37|0.776
91690103|NCT01217112|183273957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.51|STANDARD_ERROR_OF_MEAN|15.834||0.007|TWO_SIDED|90.0|17.98|71.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||71.05|17.98|0.007
91690104|NCT01217112|183273958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.536||0.717|TWO_SIDED|90.0|-0.7|1.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.09|-0.70|0.717
91690105|NCT01217112|183273958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.531||0.218|TWO_SIDED|90.0|-0.23|1.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.55|-0.23|0.218
91690106|NCT01217112|183273958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.514||0.378|TWO_SIDED|90.0|-0.4|1.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.32|-0.40|0.378
91690107|NCT01217112|183273958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.532||0.361|TWO_SIDED|90.0|-0.4|1.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.38|-0.40|0.361
91690108|NCT01217112|183273959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.417|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.417
91690109|NCT01217112|183273959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.34|TWO_SIDED|90.0|-0.01|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.01|0.340
91690110|NCT01217112|183273959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.013||0.915|TWO_SIDED|90.0|-0.02|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.02|0.915
91690111|NCT01217112|183273959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.465|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.465
91721704|NCT03074500|183335474|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
91721705|NCT03074500|183335474|SUPERIORITY|||||||0.404||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.404
91690112|NCT01217112|183273960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|1.616||0.646|TWO_SIDED|90.0|-1.96|3.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.45|-1.96|0.646
91690113|NCT01217112|183273960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.598||0.219|TWO_SIDED|90.0|-0.69|4.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.66|-0.69|0.219
91488745|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.16|||||TWO_SIDED|95.0|0.97|1.39|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.||1.39|0.97|
91488746|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.15|||||TWO_SIDED|95.0|0.94|1.42|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.||1.42|0.94|
91690114|NCT01217112|183273960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.563||0.307|TWO_SIDED|90.0|-1.0|4.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.23|-1.00|0.307
91690115|NCT01217112|183273960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.612||0.348|TWO_SIDED|90.0|-1.17|4.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.22|-1.17|0.348
91690116|NCT01217112|183273961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.299||0.187|TWO_SIDED|90.0|-0.44|3.91|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.91|-0.44|0.187
91721706|NCT03074500|183335474|SUPERIORITY|||||||0.97||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.97
91488747|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.92|1.34|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.||1.34|0.92|
91488748|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.87|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.87|
91690117|NCT01217112|183273961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|1.28||0.578|TWO_SIDED|90.0|-1.43|2.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.86|-1.43|0.578
91690118|NCT01217112|183273961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|1.249||0.368|TWO_SIDED|90.0|-0.96|3.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.22|-0.96|0.368
91527134|NCT03445065|182929557|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6411|TWO_SIDED|95.0|-2.6|1.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.6|-2.6|0.64110
91690119|NCT01217112|183273961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.304||0.696|TWO_SIDED|90.0|-1.67|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.67|0.696
91721707|NCT03074500|183335474|SUPERIORITY|||||||0.362||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.362
91721708|NCT03074500|183335474|SUPERIORITY|||||||0.271||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.271
91721709|NCT03074500|183335474|SUPERIORITY|||||||0.519||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.519
91488749|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.90|
91527135|NCT03445065|182929558|SUPERIORITY||Mean Difference (Net)|1.0||||0.339|TWO_SIDED|95.0|-1.1|3.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.1|-1.1|0.339
91690120|NCT01217112|183273962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.32||0.327|TWO_SIDED|90.0|-0.9|3.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.51|-0.90|0.327
91690121|NCT01217112|183273962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|1.303||0.851|TWO_SIDED|90.0|-1.93|2.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.43|-1.93|0.851
91690122|NCT01217112|183273962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.281||0.672|TWO_SIDED|90.0|-1.6|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.60|0.672
91690123|NCT01217112|183273962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.327||0.978|TWO_SIDED|90.0|-2.26|2.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.18|-2.26|0.978
91690124|NCT01217112|183273963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.512||0.857|TWO_SIDED|90.0|-0.95|0.76|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.76|-0.95|0.857
91690125|NCT01217112|183273963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.549||0.543|TWO_SIDED|90.0|-0.58|1.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.26|-0.58|0.543
91690126|NCT01217112|183273963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.495||0.859|TWO_SIDED|90.0|-0.74|0.92|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.92|-0.74|0.859
91690127|NCT01217112|183273963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.526||0.467|TWO_SIDED|90.0|-1.27|0.5|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.50|-1.27|0.467
91690128|NCT01217112|183273964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.406||0.124|TWO_SIDED|90.0|-1.32|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-1.32|0.124
91690129|NCT01217112|183273964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.439||0.909|TWO_SIDED|90.0|-0.68|0.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.79|-0.68|0.909
91690130|NCT01217112|183273964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.392||0.245|TWO_SIDED|90.0|-1.12|0.2|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.20|-1.12|0.245
91690131|NCT01217112|183273964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.412||0.382|TWO_SIDED|90.0|-1.05|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-1.05|0.382
91527136|NCT03445065|182929558|SUPERIORITY||Mean Difference (Net)|-0.7||||0.57677|TWO_SIDED|95.0|-3.0|1.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.7|-3.0|0.57677
91690132|NCT01217112|183273965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.837||0.376|TWO_SIDED|90.0|-2.15|0.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.66|-2.15|0.376
91690133|NCT01217112|183273965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.908||0.688|TWO_SIDED|90.0|-1.15|1.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.89|-1.15|0.688
91721710|NCT03074500|183335474|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
91721711|NCT03074500|183335474|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
91690134|NCT01217112|183273965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.803||0.637|TWO_SIDED|90.0|-1.73|0.96|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.96|-1.73|0.637
91690135|NCT01217112|183273965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.849||0.355|TWO_SIDED|90.0|-2.22|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-2.22|0.355
91690136|NCT01217112|183273966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.391||0.482|TWO_SIDED|90.0|-0.39|0.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.95|-0.39|0.482
91690137|NCT01217112|183273966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.489||0.708|TWO_SIDED|90.0|-0.65|1.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.02|-0.65|0.708
91690138|NCT01217112|183273966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.434||0.166|TWO_SIDED|90.0|-0.12|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-0.12|0.166
91690139|NCT01217112|183273966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.408||0.424|TWO_SIDED|90.0|-0.37|1.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.03|-0.37|0.424
91690140|NCT01217112|183273967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.26||0.022|TWO_SIDED|90.0|0.94|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.94|0.022
91690141|NCT01217112|183273967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|1.532||0.014|TWO_SIDED|90.0|1.44|6.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.69|1.44|0.014
91690142|NCT01217112|183273967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|1.4||0.053|TWO_SIDED|90.0|0.45|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.45|0.053
91690143|NCT01217112|183273967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|1.299||0.012|TWO_SIDED|90.0|1.33|5.78|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.78|1.33|0.012
91690144|NCT01217112|183273968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.35|STANDARD_ERROR_OF_MEAN|1.463||0.032|TWO_SIDED|90.0|0.84|5.85|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.85|0.84|0.032
91690145|NCT01217112|183273968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|1.798||0.026|TWO_SIDED|90.0|1.18|7.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.35|1.18|0.026
91527137|NCT03445065|182929559|SUPERIORITY||Mean Difference (Net)|-0.1||||0.558|TWO_SIDED|95.0|-0.3|0.2||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.2|-0.3|0.558
91690146|NCT01217112|183273968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44|STANDARD_ERROR_OF_MEAN|1.626||0.046|TWO_SIDED|90.0|0.65|6.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.22|0.65|0.046
91690147|NCT01217112|183273968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.512||0.018|TWO_SIDED|90.0|1.26|6.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.45|1.26|0.018
91690148|NCT01217112|183273969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.806||0.294|TWO_SIDED|90.0|-0.52|2.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.25|-0.52|0.294
91690149|NCT01217112|183273969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|0.988||0.092|TWO_SIDED|90.0|0.05|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|0.05|0.092
91690150|NCT01217112|183273969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|0.893||0.173|TWO_SIDED|90.0|-0.28|2.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.79|-0.28|0.173
91690151|NCT01217112|183273969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.837||0.545|TWO_SIDED|90.0|-0.92|1.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.95|-0.92|0.545
91690152|NCT01217112|183273970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.67|STANDARD_ERROR_OF_MEAN|1.214||0.038|TWO_SIDED|90.0|0.59|4.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.75|0.59|0.038
91690153|NCT01217112|183273970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|1.486||0.004|TWO_SIDED|90.0|2.16|7.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.26|2.16|0.004
91690154|NCT01217112|183273970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.35||0.088|TWO_SIDED|90.0|0.09|4.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.72|0.09|0.088
91690155|NCT01217112|183273970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|1.252||0.01|TWO_SIDED|90.0|1.39|5.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.68|1.39|0.010
91690156|NCT01217112|183273971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.814||0.064|TWO_SIDED|90.0|0.42|6.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.64|0.42|0.064
91690157|NCT01217112|183273971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.55|STANDARD_ERROR_OF_MEAN|2.237||0.008|TWO_SIDED|90.0|2.72|10.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.38|2.72|0.008
91690158|NCT01217112|183273971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|2.016||0.084|TWO_SIDED|90.0|0.19|7.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.10|0.19|0.084
91690159|NCT01217112|183273971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.871||0.041|TWO_SIDED|90.0|0.84|7.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.25|0.84|0.041
91690160|NCT01217112|183273972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.129|TWO_SIDED|90.0|-0.14|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.14|0.129
91690161|NCT01217112|183273972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.051||0.961|TWO_SIDED|90.0|-0.08|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.08|0.961
91690162|NCT01217112|183273972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.128|TWO_SIDED|90.0|-0.16|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.16|0.128
91690163|NCT01217112|183273972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.045||0.3|TWO_SIDED|90.0|-0.12|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.12|0.300
91690164|NCT01217112|183273973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|5.38||0.625|TWO_SIDED|90.0|-6.37|11.67|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||11.67|-6.37|0.625
91690165|NCT01217112|183273973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.77|STANDARD_ERROR_OF_MEAN|5.519||0.226|TWO_SIDED|90.0|-2.48|16.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||16.02|-2.48|0.226
91527138|NCT03445065|182929559|SUPERIORITY||Mean Difference (Net)|-0.1||||0.408|TWO_SIDED|95.0|-0.3|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.1|-0.3|0.408
91690166|NCT01217112|183273973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|5.103||0.904|TWO_SIDED|90.0|-7.94|9.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||9.18|-7.94|0.904
91488750|NCT03439657|182849801|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.96|1.5|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.||1.50|0.96|
91527139|NCT03445065|182929560|SUPERIORITY||Mean Difference (Net)|0.1||||0.616|TWO_SIDED|95.0|-0.2|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.4|-0.2|0.616
91527140|NCT03315130|182929581|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.7|=|0.0941|TWO_SIDED|80.0|-4.5|-0.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.1|-4.5|=0.0941
91690167|NCT01217112|183273973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|5.71||0.285|TWO_SIDED|90.0|-3.41|15.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||15.75|-3.41|0.285
91690168|NCT01217112|183273974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.568||0.138|TWO_SIDED|90.0|-1.81|0.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.10|-1.81|0.138
91527141|NCT03315130|182929581|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.7|=|0.0538|TWO_SIDED|80.0|-5.1|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-5.1|=0.0538
91527142|NCT03315130|182929582|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.3|=|0.047|TWO_SIDED|80.0|-3.9|-0.5||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.5|-3.9|=0.0470
91690169|NCT01217112|183273974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.547||0.505|TWO_SIDED|90.0|-1.28|0.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.55|-1.28|0.505
91690170|NCT01217112|183273974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.54||0.743|TWO_SIDED|90.0|-0.73|1.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.08|-0.73|0.743
91690171|NCT01217112|183273974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.565||0.54|TWO_SIDED|90.0|-0.6|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-0.60|0.540
91721712|NCT03074500|183335474|SUPERIORITY|||||||0.973|||||||Friedman's two-way analysis of variance|||||||0.973
91690172|NCT01217112|183273976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.664||0.701|TWO_SIDED|90.0|-2.14|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|-2.14|0.701
91690173|NCT01217112|183273976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|1.662||0.006|TWO_SIDED|90.0|1.99|7.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.55|1.99|0.006
91690174|NCT01217112|183273976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.589||0.542|TWO_SIDED|90.0|-1.68|3.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.64|-1.68|0.542
91690175|NCT01217112|183273976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.627||0.827|TWO_SIDED|90.0|-2.36|3.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.08|-2.36|0.827
91690176|NCT00127231|183273980|EQUIVALENCE||Odds Ratio (OR)|0.42|||<|0.005|TWO_SIDED|95.0|0.23|0.75|||Mixed Models Analysis|||Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.||0.75|0.23|<0.005
91690177|NCT03588910|183273999|SUPERIORITY|Wilcoxon rank-sum tests||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||.87
91690178|NCT03588910|183274000|SUPERIORITY|Wilcoxon rank-sum tests||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||.36
91690179|NCT03588910|183274001|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||.91
91690180|NCT03588910|183274002|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
91690181|NCT03588910|183274003|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||.36
91690182|NCT03096314|183274004|SUPERIORITY|||||||0.26|||||||Generalized linear model|||||||0.26
91690183|NCT03096314|183274005|SUPERIORITY||Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-0.1|8.6||||||||8.6|-0.1|
91690184|NCT03096314|183274006|SUPERIORITY||Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-0.5|8.0||||||||8.0|-0.5|
91690185|NCT03096314|183274007|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-5.4|6.0||||||||6.0|-5.4|
91690186|NCT03096314|183274008|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-2.7|0.0||||||||0.0|-2.7|
91690187|NCT03096314|183274009|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.8|0.4||||||||0.4|-4.8|
91690188|NCT03096314|183274010|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5||||||||0.5|-2.1|
91690189|NCT03096314|183274011|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|0|
91690190|NCT03096314|183274012|SUPERIORITY||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-2.1|3.6||||||||3.6|-2.1|
91690191|NCT03096314|183274013|SUPERIORITY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-22.0|34.9||||||Mild ARDS||34.9|-22.0|
91690192|NCT03096314|183274013|SUPERIORITY||Risk Difference (RD)|-25.6|||||TWO_SIDED|95.0|-56.3|5.1||||||Moderate ARDS||5.1|-56.3|
91690193|NCT03096314|183274013|SUPERIORITY||Risk Difference (RD)|19.1|||||TWO_SIDED|95.0|-2.9|41.1||||||Severe ARDS||41.1|-2.9|
91690194|NCT03096314|183274014|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-7.3|5.0||||||No AKI||5.0|-7.3|
91690195|NCT03096314|183274014|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-5.6|3.4||||||Mild AKI||3.4|-5.6|
91690196|NCT03096314|183274014|SUPERIORITY||Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Moderate AKI||3.2|-4.4|
91690197|NCT03096314|183274014|SUPERIORITY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-1.7|7.3||||||Severe AKI||7.3|-1.7|
91690198|NCT03096314|183274015|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-1.9|2.9||||||||2.9|-1.9|
91690199|NCT03096314|183274016|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
91690200|NCT03096314|183274017|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-4.4|5.1||||||||5.1|-4.4|
91690201|NCT03096314|183274018|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
91690202|NCT03096314|183274019|SUPERIORITY||Mean Difference (Final Values)|35.5|||||TWO_SIDED|95.0|31.5|39.6||||||||39.6|31.5|
91690203|NCT03096314|183274020|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91690204|NCT03096314|183274021|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91690205|NCT03096314|183274022|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
91488751|NCT02925117|182849826|SUPERIORITY||Least Squares (LS) Mean Difference|-51.4|STANDARD_ERROR_OF_MEAN|7.65|<|0.001|TWO_SIDED|95.0|-66.5|-36.3|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-36.3|-66.5|< 0.001
91690206|NCT03096314|183274023|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
91690207|NCT03096314|183274024|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
91690208|NCT03096314|183274025|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
91690209|NCT01479465|183274046|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0395|TWO_SIDED|95.0|1.01|2.06|||Log Rank|||"The null hypothesis was that the hazard ratio (HR) equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% confidence interval \[CI\]) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level Eastern Cooperative Oncology Group (ECOG) performance status (0 or \> 0) at randomization."||2.06|1.01|0.0395
91690210|NCT01479465|183274046|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.1042|TWO_SIDED|95.0|0.92|1.89|||Log Rank|||"The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or \> 0) at randomization."||1.89|0.92|0.1042
91690211|NCT02562066|183274082|OTHER||Mean Difference (Net)|1.63||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.085
91690212|NCT02562066|183274082|OTHER||Mean Difference (Net)|0.56|||||TWO_SIDED|95.0|-0.97|2.09|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with SGI raw scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||2.09|-0.97|
91690213|NCT02562066|183274083|OTHER||Mean Difference (Net)|3.17||||0.376|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.376
91690214|NCT02562066|183274083|OTHER||Mean Difference (Net)|1.14|||||TWO_SIDED|95.0|-2.31|4.58|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-32 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||4.58|-2.31|
91690215|NCT02562066|183274084|OTHER||Mean Difference (Net)|-1.0||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.800
91690216|NCT02562066|183274084|OTHER||Mean Difference (Net)|0.63|||||TWO_SIDED|95.0|-5.25|6.5|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-20 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||6.50|-5.25|
91721713|NCT03074500|183335474|SUPERIORITY|||||||0.886|||||||Friedman's two-way analysis of variance|||||||0.886
91488752|NCT02925117|182849826|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|95.0|-53.7|-23.6|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-23.6|-53.7|<0.001
91488753|NCT02925117|182849826|SUPERIORITY||LS Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|7.61||0.032|TWO_SIDED|95.0|-31.4|-1.4|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-1.4|-31.4|0.032
91527143|NCT03315130|182929582|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.3|=|0.0392|TWO_SIDED|80.0|-4.0|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-4.0|=0.0392
91527144|NCT03315130|182929583|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.4|=|0.017|TWO_SIDED|80.0|-8.4|-2.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-2.1|-8.4|=0.0170
91690217|NCT01234350|183274098|OTHER||IRR|0.829||||0.4007|TWO_SIDED|95.0|0.536|1.283||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|The IRs were estimated using a Poisson-mixture regression model.||1.283|0.536|0.4007
91690218|NCT01234350|183274099|OTHER||IRR|0.874||||0.671|TWO_SIDED|95.0|0.47|1.626||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.||1.626|0.470|0.6710
91690219|NCT01234350|183274099|OTHER||IRR|1.857||||0.4544|TWO_SIDED|95.0|0.367|9.403||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For bone fracture events. The IRs were estimated using Poisson-mixture regression model.||9.403|0.367|0.4544
91527145|NCT03315130|182929583|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|2.4|=|0.0624|TWO_SIDED|80.0|-6.9|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-6.9|=0.0624
91690220|NCT01234350|183274100|OTHER||IRR|1.193||||0.2529|TWO_SIDED|95.0|0.882|1.613||Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.||1.613|0.882|0.2529
91690221|NCT01234350|183274100|OTHER||IRR|2.623||||0.0208|TWO_SIDED|95.0|1.158|5.944||Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For T2DM. The IRs were estimated using Poisson-mixture regression model.||5.944|1.158|0.0208
91721714|NCT03074500|183335474|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.82
91488754|NCT02925117|182849827|SUPERIORITY||Adjusted Difference|58.7|||<|0.001|TWO_SIDED|95.0|42.5|74.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||74.8|42.5|< 0.001
91488755|NCT02925117|182849827|SUPERIORITY||Adjusted Difference|42.5|||<|0.001|TWO_SIDED|95.0|25.5|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||59.6|25.5|<0.001
91488756|NCT02925117|182849827|SUPERIORITY||Adjusted Difference|18.7||||0.022|TWO_SIDED|95.0|2.7|34.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||34.7|2.7|0.022
91488757|NCT02925117|182849828|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.1|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||62.7|31.1|<0.001
91527146|NCT03315130|182929584|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.2|=|0.1866|TWO_SIDED|80.0|-4.9|0.9||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||0.9|-4.9|=0.1866
91527147|NCT03315130|182929584|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.2|=|0.0391|TWO_SIDED|80.0|-7.0|-1.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-1.1|-7.0|=0.0391
91488758|NCT02925117|182849828|SUPERIORITY||Adjusted Difference|28.6|||<|0.001|TWO_SIDED|95.0|13.8|43.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||43.4|13.8|<0.001
91488759|NCT02925117|182849828|SUPERIORITY||Adjusted Difference|11.9||||0.044|TWO_SIDED|95.0|0.3|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||23.5|0.3|0.044
91527148|NCT03315130|182929588|SUPERIORITY||LS Mean Difference|-82.597|STANDARD_ERROR_OF_MEAN|3.563|<|0.0001|TWO_SIDED|80.0|-87.249|-77.946||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-77.946|-87.249|<0.0001
91527149|NCT03315130|182929588|SUPERIORITY||LS Mean Difference|-95.689|STANDARD_ERROR_OF_MEAN|3.91|<|0.0001|TWO_SIDED|80.0|-100.794|-90.585||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-90.585|-100.794|<0.0001
91527150|NCT03315130|182929589|SUPERIORITY||LS Mean Difference|60.123|STANDARD_ERROR_OF_MEAN|9.394|<|0.0001|TWO_SIDED|80.0|47.839|72.408||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||72.408|47.839|<0.0001
91488760|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-59.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-72.3|-46.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-46.3|-72.3|<0.001
91488761|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-47.7|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-61.1|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-34.3|-61.1|<0.001
91527151|NCT03315130|182929589|SUPERIORITY||LS Mean Difference|57.076|STANDARD_ERROR_OF_MEAN|9.269|<|0.0001|TWO_SIDED|80.0|44.955|69.197||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||69.197|44.955|<0.0001
91690222|NCT01234350|183274107|OTHER||Odds Ratio (OR)|0.747||||0.0821|TWO_SIDED|95.0|0.537|1.038||A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.|Regression, Logistic|Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.||The analyses of all-cause mortality was based on logistic regressions.||1.038|0.537|0.0821
91690223|NCT00289848|183274108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_DEVIATION|1.08|<|0.001||95.0|-1.23|-0.83|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline A1C as a covariate||||-0.83|-1.23|<0.001
91690224|NCT00289848|183274109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_DEVIATION|39.8|<|0.001||95.0|-38.4|-23.7|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline FPG as a covariate||||-23.7|-38.4|<0.001
91690225|NCT00289848|183274110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.6|STANDARD_DEVIATION|59.2|<|0.001||95.0|-68.8|-44.3|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline 2-hr PMG as a covariate||||-44.3|-68.8|<0.001
91690226|NCT01839708|183274111|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91690227|NCT01839708|183274112|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91690228|NCT01839708|183274113|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690229|NCT01839708|183274114|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91690230|NCT01839708|183274115|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690231|NCT01839708|183274116|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91690232|NCT01839708|183274117|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91488762|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|6.7|<|0.001|TWO_SIDED|95.0|-44.3|-17.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-17.8|-44.3|<0.001
91488763|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|8.85|<|0.001|TWO_SIDED|95.0|-83.9|-48.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-48.9|-83.9|<0.001
91690233|NCT01839708|183274118|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690234|NCT01839708|183274119|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690235|NCT01839708|183274120|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690236|NCT01839708|183274121|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690237|NCT01839708|183274122|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690238|NCT01839708|183274123|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690239|NCT01839708|183274124|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91690240|NCT00191477|183274161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.777||95.0|0.643|1.392||Only 87 recurrences and 7 deaths were documented at planned end of follow-up. The study was stopped early for futility reasons based on an interim analysis using pre-defined stopping boundaries for the hazard ratio (HR) of RFS.|Log Rank|||Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).||1.392|0.643|0.777
91721715|NCT03074500|183335474|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.017
91721716|NCT03074500|183335474|SUPERIORITY|||||||0.734|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.734
91488764|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|9.13|<|0.001|TWO_SIDED|95.0|-56.4|-20.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-20.4|-56.4|<0.001
91488765|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|8.96||0.002|TWO_SIDED|95.0|-46.6|-11.2|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-11.2|-46.6|0.002
91488766|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|9.78|<|0.001|TWO_SIDED|95.0|-78.6|-39.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-39.9|-78.6|<0.001
91488767|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-38.3|STANDARD_ERROR_OF_MEAN|10.08|<|0.001|TWO_SIDED|95.0|-58.3|-18.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-18.4|-58.3|<0.001
91488768|NCT02925117|182849829|SUPERIORITY||LS Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.9||0.003|TWO_SIDED|95.0|-49.4|-10.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-10.3|-49.4|0.003
91488769|NCT02925117|182849830|SUPERIORITY||LS Mean Difference|-65.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.001|TWO_SIDED|95.0|-80.0|-50.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-50.5|-80.0|<0.001
91488770|NCT02925117|182849830|SUPERIORITY||LS Mean Difference|-47.9|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-62.6|-33.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-33.3|-62.6|<0.001
91690241|NCT02224157|183274204|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Upper limit of the 1-sided 95% confidence limit \<1.2 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid|Rate ratio|0.97|||||ONE_SIDED|95.0||1.16|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.16||
91488771|NCT02925117|182849830|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-40.8|-11.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-11.5|-40.8|<0.001
91488772|NCT02925117|182849831|SUPERIORITY||LS Mean Difference|-58.3|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-71.7|-44.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-44.9|-71.7|<0.001
91488773|NCT02925117|182849831|SUPERIORITY||LS Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|6.94|<|0.001|TWO_SIDED|95.0|-50.8|-23.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-23.4|-50.8|<0.001
91488774|NCT02925117|182849831|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|6.81|<|0.001|TWO_SIDED|95.0|-41.9|-15.0|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-15.0|-41.9|<0.001
91488775|NCT02925117|182849831|SUPERIORITY||LS Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|6.93|<|0.001|TWO_SIDED|95.0|-61.7|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-34.3|-61.7|<0.001
91488776|NCT02925117|182849831|SUPERIORITY||LS Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-48.5|-20.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-20.5|-48.5|<0.001
91488777|NCT02925117|182849831|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|6.96||0.004|TWO_SIDED|95.0|-33.9|-6.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-6.4|-33.9|0.004
91488778|NCT02925117|182849832|SUPERIORITY||Adjusted Difference|72.7|||<|0.001|TWO_SIDED|95.0|58.3|87.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||87.1|58.3|<0.001
91488779|NCT02925117|182849832|SUPERIORITY||Adjusted Difference|44.9|||<|0.001|TWO_SIDED|95.0|27.9|61.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||61.9|27.9|<0.001
91488780|NCT02925117|182849832|SUPERIORITY||Adjusted Difference|23.4||||0.004|TWO_SIDED|95.0|7.5|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||39.4|7.5|0.004
91488781|NCT02925117|182849833|SUPERIORITY||Adjusted Difference|70.7|||<|0.001|TWO_SIDED|95.0|56.2|85.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||85.2|56.2|<0.001
91488782|NCT02925117|182849833|SUPERIORITY||Adjusted Difference|49.0|||<|0.001|TWO_SIDED|95.0|30.8|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||67.3|30.8|<0.001
91488783|NCT02925117|182849833|SUPERIORITY||Adjusted Difference|32.8|||<|0.001|TWO_SIDED|95.0|13.4|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||52.2|13.4|<0.001
91488784|NCT02925117|182849833|SUPERIORITY||Adjusted Difference|60.6|||<|0.001|TWO_SIDED|95.0|45.3|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||75.9|45.3|<0.001
91488785|NCT02925117|182849833|SUPERIORITY||Adjusted Difference|48.6|||<|0.001|TWO_SIDED|95.0|31.3|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||65.9|31.3|<0.001
91488786|NCT02925117|182849833|SUPERIORITY||Adjusted Difference|28.2||||0.003|TWO_SIDED|95.0|9.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||46.6|9.8|0.003
91690242|NCT02224157|183274205|SUPERIORITY||Hazard Ratio (HR)|0.955||||0.664|TWO_SIDED|95.0|0.777|1.174|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.174|0.777|0.664
91527152|NCT00524030|182929594|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||Null hypothesis (H0): Exit rate greater than or equal to (≥)74%||||<0.001
91527153|NCT00524030|182929594|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exite rate ≥68%||||<0.001
91488787|NCT02925117|182849834|SUPERIORITY||Adjusted Difference|43.8|||<|0.001|TWO_SIDED|95.0|29.1|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||58.5|29.1|<0.001
91488788|NCT02925117|182849834|SUPERIORITY||Adjusted Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||39.6|12.6|<0.001
91527154|NCT00524030|182929595|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥74%||||<0.001
91527155|NCT00524030|182929595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥68%||||0.001
91527156|NCT05473000|182929640|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
91527157|NCT02714205|182929641|SUPERIORITY||Model generated Least Square Mean|-0.54||||0.34|TWO_SIDED|95.0|-1.66|0.58|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.58|-1.66|0.34
91690243|NCT02224157|183274206|SUPERIORITY||Least Square Mean Difference|-32.6||||0.003|TWO_SIDED|95.0|-53.7|-11.4|||Mixed Models Analysis|Rand treatment,pre-study treatment,region,visit,rand treatment by visit; fixed effects. Patient; random effect, baseline FEV1; covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. Estimate corresponds to average treatment effect across all treatment visits.|||-11.4|-53.7|0.003
91527158|NCT02714205|182929642|SUPERIORITY||Model generated Least Square Mean|0.51||||0.88|TWO_SIDED|95.0|-6.15|7.18|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|||7.18|-6.15|0.88
91527159|NCT02714205|182929643|SUPERIORITY||Model generated Least Square Mean|-0.2||||0.57|TWO_SIDED|95.0|-0.88|0.48|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.48|-0.88|0.57
91488789|NCT02925117|182849834|SUPERIORITY||Adjusted Difference|9.4||||0.051|TWO_SIDED|95.0|0.0|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||18.8|-0.0|0.051
91488790|NCT02925117|182849834|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.3|62.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||62.4|31.3|<0.001
91527160|NCT02714205|182929644|SUPERIORITY||Model generated Least Square Mean Differ|-0.09||||0.81|TWO_SIDED|95.0|-0.8|0.63|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.63|-0.8|0.81
91527161|NCT02714205|182929645|SUPERIORITY||Model generated Least Square Mean Differ|0.43||||0.3|TWO_SIDED|95.0|-0.38|1.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||1.23|-0.38|0.3
91527162|NCT02714205|182929646|SUPERIORITY||Model generated Least Square Mean Differ|0.4||||0.68|TWO_SIDED|95.0|-1.52|2.32|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||2.32|-1.52|0.68
91488791|NCT02925117|182849834|SUPERIORITY||Adjusted Difference|23.8||||0.001|TWO_SIDED|95.0|9.6|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||38.1|9.6|0.001
91488792|NCT02925117|182849834|SUPERIORITY||Adjusted Difference|11.8||||0.049|TWO_SIDED|95.0|0.1|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||23.6|0.1|0.049
91527163|NCT02714205|182929647|SUPERIORITY||Model generated Least Square Mean Differ|-0.83||||0.12|TWO_SIDED|95.0|-1.89|0.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.23|-1.89|0.12
91527164|NCT02714205|182929648|SUPERIORITY||Model generated Least Square Mean Differ|-1.41||||0.25|TWO_SIDED|95.0|-3.81|0.99|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.99|-3.81|0.25
91527165|NCT00186498|182929655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Test of within subjects contrast: CVLT Long Delay Free Recall Time 1 (baseline) vs Time 2 (30 days): Placebo (F 4.093) p= 0.071; Memantine (F 35.042) p=0.006|Regression, Linear|||||||0.006
91527166|NCT01693692|182929665|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.25||0.1683|ONE_SIDED|95.0||0.2|||ANCOVA|||||0.2||0.1683
91527167|NCT01693692|182929665|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.25||0.0277|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0277
91690244|NCT02224157|183274208|SUPERIORITY||Least Square Mean Difference|0.03|||||TWO_SIDED|95.0|0.0|0.07||No p-value was calculated for this efficacy variable|ANCOVA|Model with randomised treatment, pre-study treatment and region as factors, and no. of 'as needed' inhalations at baseline as continuous covariate|A mean difference less than zero indicates a larger mean reduction in number of 'as needed' inhalations in the Symbicort 'as needed' group.|||0.07|0.00|
91488793|NCT02925117|182849835|SUPERIORITY||Adjusted Difference|68.4|||<|0.001|TWO_SIDED|95.0|54.0|82.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||82.8|54.0|<0.001
91488794|NCT02925117|182849835|SUPERIORITY||Adjusted Difference|35.3|||<|0.001|TWO_SIDED|95.0|18.5|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||52.2|18.5|<0.001
91488795|NCT02925117|182849835|SUPERIORITY||Adjusted Difference|25.7||||0.002|TWO_SIDED|95.0|9.6|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||41.7|9.6|0.002
91488796|NCT02925117|182849835|SUPERIORITY||Adjusted Difference|54.5|||<|0.001|TWO_SIDED|95.0|39.0|69.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||69.9|39.0|<0.001
91488797|NCT02925117|182849835|SUPERIORITY||Adjusted Difference|35.8|||<|0.001|TWO_SIDED|95.0|19.1|52.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||52.5|19.1|<0.001
91527168|NCT01693692|182929666|SUPERIORITY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|2.48||0.2637|ONE_SIDED|95.0||2.5|||ANCOVA|||||2.5||0.2637
91488798|NCT02925117|182849835|SUPERIORITY||Adjusted Difference|21.2||||0.008|TWO_SIDED|95.0|5.7|36.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||36.8|5.7|0.008
91488799|NCT02925117|182849836|SUPERIORITY||Adjusted Difference|30.4|||<|0.001|TWO_SIDED|95.0|16.2|44.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||44.6|16.2|<0.001
91488800|NCT02925117|182849836|SUPERIORITY||Adjusted Difference|9.4||||0.052|TWO_SIDED|95.0|-0.1|18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.9|-0.1|0.052
91488801|NCT02925117|182849836|SUPERIORITY||Adjusted Difference|9.3||||0.048|TWO_SIDED|95.0|0.1|18.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.5|0.1|0.048
91488802|NCT02925117|182849836|SUPERIORITY||Adjusted Difference|37.7|||<|0.001|TWO_SIDED|95.0|22.2|53.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||53.3|22.2|<0.001
91527169|NCT01693692|182929666|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|2.47||0.0097|ONE_SIDED|95.0||-1.7|||ANCOVA|||||-1.7||0.0097
91690245|NCT02224157|183274209|SUPERIORITY||Least Square Mean Difference|-6.85|||<|0.001|TWO_SIDED|95.0|-8.37|-5.34|||ANCOVA|adjusted for randomised treatment, pre-study treatment and region as factors and the percent 'as needed' free days during run-in as a cont covariate.|An estimate of difference \>0 means that there was a larger increase in the % of 'as needed' free days in the Symbicort 'as-needed' arm.|||-5.34|-8.37|< 0.001
91690246|NCT02224157|183274210|SUPERIORITY||Least Square Mean Difference|-37.48|||<|0.001|TWO_SIDED|95.0|-39.18|-35.77|||ANOVA|model adjusted for: randomised treatment, pre-study treatment and region.|An estimate of difference \>0 means that there was a higher % of controller use days in the Symbicort 'as-needed' group.|||-35.77|-39.18|<0.001
91488803|NCT02925117|182849836|SUPERIORITY||Adjusted Difference|19.0||||0.006|TWO_SIDED|95.0|5.6|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||32.5|5.6|0.006
91488804|NCT02925117|182849836|SUPERIORITY||Adjusted Difference|2.4||||0.581|TWO_SIDED|95.0|-6.0|10.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||10.8|-6.0|0.581
91488805|NCT02925117|182849837|SUPERIORITY||Adjusted Difference|14.2||||0.012|TWO_SIDED|95.0|3.2|25.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||25.2|3.2|0.012
91488806|NCT02925117|182849837|SUPERIORITY||Adjusted Difference|2.3||||0.428|TWO_SIDED|95.0|-3.4|8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||8.0|-3.4|0.428
91488807|NCT02925117|182849837|SUPERIORITY||Adjusted Difference|4.6||||0.206|TWO_SIDED|95.0|-2.5|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||11.8|-2.5|0.206
91488808|NCT02925117|182849837|SUPERIORITY||Adjusted Difference|23.3|||<|0.001|TWO_SIDED|95.0|10.4|36.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||36.2|10.4|<0.001
91527170|NCT01693692|182929667|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.0639|ONE_SIDED|95.0||0.0|||ANCOVA|||||0.0||0.0639
91527171|NCT01693692|182929667|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.007|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0070
91690247|NCT02224157|183274211|SUPERIORITY||Least Square Mean Difference|0.109|||<|0.001|TWO_SIDED|95.0|0.068|0.15|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random, and baseline ACQ-5 as covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.150|0.068|<0.001
91690248|NCT02224157|183274212|SUPERIORITY||Least Square Mean Difference|-0.096|||<|0.001|TWO_SIDED|95.0|-0.137|-0.054|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random and baseline AQLQ as covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.054|-0.137|<0.001
91690249|NCT02224157|183274213|SUPERIORITY||Rate ratio|0.97||||0.754|TWO_SIDED|95.0|0.78|1.2|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.20|0.78|0.754
91488809|NCT02925117|182849837|SUPERIORITY||Adjusted Difference|9.4||||0.048|TWO_SIDED|95.0|0.1|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||18.8|0.1|0.048
91488810|NCT02925117|182849837|SUPERIORITY||Adjusted Difference|2.4||||0.426|TWO_SIDED|95.0|-3.4|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||8.1|-3.4|0.426
91488811|NCT02925117|182849843|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-34.9|-18.1|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-18.1|-34.9|<0.001
91488812|NCT02925117|182849843|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-31.4|-14.6|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-14.6|-31.4|<0.001
91488813|NCT02925117|182849843|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.25||0.075|TWO_SIDED|95.0|-16.0|0.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||0.8|-16.0|0.075
91488814|NCT02925117|182849844|SUPERIORITY||Adjusted Difference|47.4|||<|0.001|TWO_SIDED|95.0|29.6|65.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||65.2|29.6|<0.001
91488815|NCT02925117|182849844|SUPERIORITY||Adjusted Difference|53.4|||<|0.001|TWO_SIDED|95.0|35.5|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||71.3|35.5|<0.001
91527689|NCT01976364|182930494|OTHER||LS mean difference|-0.25|||||TWO_SIDED|95.0|-2.4|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.90|-2.40|
91488816|NCT02925117|182849844|SUPERIORITY||Adjusted Difference|18.6||||0.021|TWO_SIDED|95.0|2.8|34.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||34.3|2.8|0.021
91488817|NCT02663908|182849847|OTHER||Hazard Ratio (HR)|1.283||||0.5294|TWO_SIDED|95.0|0.589|2.794|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.794|0.589|0.5294
91488818|NCT02663908|182849848|OTHER||Hazard Ratio (HR)|1.204||||0.7126|TWO_SIDED|95.0|0.448|3.234|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||3.234|0.448|0.7126
91488819|NCT02663908|182849849|OTHER||Hazard Ratio (HR)|0.186||||0.0853|TWO_SIDED|95.0|0.022|1.595|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.595|0.022|0.0853
91488820|NCT02663908|182849850|OTHER||Hazard Ratio (HR)|1.594||||0.5196|TWO_SIDED|95.0|0.381|6.673|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||6.673|0.381|0.5196
91488821|NCT02663908|182849851|OTHER||Hazard Ratio (HR)|0.899||||0.8966|TWO_SIDED|95.0|0.181|4.457|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||4.457|0.181|0.8966
91488822|NCT02663908|182849852|OTHER||Hazard Ratio (HR)|0.48||||0.3857|TWO_SIDED|95.0|0.088|2.62|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.620|0.088|0.3857
91488823|NCT02663908|182849853|OTHER||Hazard Ratio (HR)|0.839||||0.718|TWO_SIDED|95.0|0.324|2.176|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.176|0.324|0.7180
91488824|NCT02663908|182849855|OTHER||Hazard Ratio (HR)|0.887||||0.6701|TWO_SIDED|95.0|0.512|1.539|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.539|0.512|0.6701
91488825|NCT02663908|182849856|OTHER||Treatment Difference|-0.907||||0.1193|TWO_SIDED|95.0|-2.048|0.235|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 168||0.235|-2.048|0.1193
91488826|NCT02663908|182849856|OTHER||Treatment Difference|-0.213||||0.108|TWO_SIDED|95.0|-0.473|0.047|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 168||0.047|-0.473|0.1080
91488827|NCT02663908|182849856|OTHER||Treatment Difference|-0.916||||0.1256|TWO_SIDED|95.0|-2.089|0.257|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 336||0.257|-2.089|0.1256
91488828|NCT02663908|182849856|OTHER||Treatment Difference|-0.047||||0.7261|TWO_SIDED|95.0|-0.312|0.218|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 336||0.218|-0.312|0.7261
91488829|NCT02663908|182849860|OTHER||Treatment difference|-0.002||||0.911|TWO_SIDED|95.0|-0.036|0.032|||ANCOVA|Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.||||0.032|-0.036|0.9110
91488830|NCT02663908|182849861|OTHER||Treatment Difference|-1.57||||0.0936|TWO_SIDED|95.0|-3.41|0.27|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 168||0.27|-3.41|0.0936
91488831|NCT02663908|182849861|OTHER||Treatment Difference|0.84||||0.4|TWO_SIDED|95.0|-1.11|2.78|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 336||2.78|-1.11|0.4000
91488832|NCT02663908|182849862|OTHER||Treatment Difference|0.045||||0.2535|TWO_SIDED|95.0|-0.032|0.122|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 168||0.122|-0.032|0.2535
91488833|NCT02663908|182849862|OTHER||Treatment Difference|0.036||||0.437|TWO_SIDED|95.0|-0.055|0.127|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 168||0.127|-0.055|0.4370
91488834|NCT02663908|182849862|OTHER||Treatment Difference|0.116||||0.0852|TWO_SIDED|95.0|-0.016|0.248|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 168||0.248|-0.016|0.0852
91488835|NCT02663908|182849862|OTHER||Treatment Difference|0.012||||0.8156|TWO_SIDED|95.0|-0.087|0.111|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 168||0.111|-0.087|0.8156
91488836|NCT02663908|182849862|OTHER||Treatment Difference|0.051||||0.2299|TWO_SIDED|95.0|-0.033|0.135|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 336||0.135|-0.033|0.2299
91488837|NCT02663908|182849862|OTHER||Treatment Difference|0.038||||0.444|TWO_SIDED|95.0|-0.06|0.136|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 336||0.136|-0.060|0.4440
91488838|NCT02663908|182849862|OTHER||Treatment Difference|0.007||||0.9172|TWO_SIDED|95.0|-0.131|0.146|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 336||0.146|-0.131|0.9172
91488839|NCT02663908|182849862|OTHER||Treatment Difference|0.093||||0.1028|TWO_SIDED|95.0|-0.019|0.204|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 336||0.204|-0.019|0.1028
91690250|NCT05906628|183274214|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|4.48|21.49|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||||21.49|4.48|<0.0001
91488840|NCT00502944|182849886|SUPERIORITY_OR_OTHER||Rate Difference (%)|30.0|||<|0.001|TWO_SIDED|95.0|27.0|32.0|||Chi-squared|||HIV test completed among patients randomized||32|27|<0.001
91488841|NCT00502944|182849887|SUPERIORITY_OR_OTHER||Rate Difference (%)|44.0|||<|0.001|TWO_SIDED|95.0|42.0|47.0|||Chi-squared|||HIV test offered||47|42|<0.001
91488842|NCT00502944|182849888|SUPERIORITY_OR_OTHER||Rate Difference (%)|-4.0||||0.02|TWO_SIDED|95.0|-8.0|-1.0|||Chi-squared|||HIV test accepted among patients offered||-1|-8|0.02
91488843|NCT01892865|182849892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.6||||0.024|TWO_SIDED|95.0|3.15|44.0|||t-test, 2 sided|||The null hypothesis was that there would be no difference in predictive imprecision for the end of the operative day between the two arms||44|3.15|0.024
91488844|NCT01892865|182849892|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson regression|||Null hypothesis: There would be no difference in throughput between the two arms||1.34|1.01|0.04
91488845|NCT01892865|182849893|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson Regression|||Null hypothesis was that there was no difference in throughput between the two scheduling methods||1.34|1.01|0.04
91488846|NCT01892865|182849894|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Null hypothesis: There would be no difference in personnel satisfaction between the groups||||0.04
91488847|NCT01892865|182849895|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Null hypothesis was that there would be no difference in the adverse event rates between the two scheduling methodologies||||0.44
91488848|NCT03320057|182849919|OTHER|We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist.|Beta Coefficient|0.14|||<|0.05|TWO_SIDED|95.0|0.11|0.17|||Regression, Linear||Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline.|Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score.||0.17|0.11|<0.05
91488849|NCT06956170|182849920|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.1|2.78|||||Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.|||2.78|0.10|
91488850|NCT02280304|182849980|SUPERIORITY||||||>|0.05||||||A priori threshold = voxel p\<.001, cluster p\<.05, FDR whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design. To report NS p-values and associated z-scores, uncorrected cluster ps were queried.|t-test, 1 sided|||Z-scores represent Fisher transformed correlation coefficients representing the correlations between hypothesized regions. Positive values represents positive connectivity between regions. Negative values represent anticorrelations, or negative relations, between hypothesized regions.||||>0.05
91488851|NCT02280304|182849981|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
91488852|NCT02280304|182849981|OTHER||Cohen's d|0.35|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation subscale of the CRIS, Post - Pre|||||
91488853|NCT02280304|182849981|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
91488854|NCT02280304|182849981|OTHER||Cohen's d|0.14|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation Scale of the Cris pre- post|||||
91488855|NCT02280304|182849981|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
91488856|NCT02280304|182849981|OTHER||Cohen's d|0.2|||||TWO_SIDED||||||||Cohens d reflects the Cris pre post Perceived Limitations scale|||||
91488857|NCT02280304|182849981|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
91488858|NCT02280304|182849981|OTHER||Cohens d|0.53|||||TWO_SIDED|||||||||||||
91488859|NCT02280304|182849981|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|||||||||||||
91690251|NCT05906628|183274214|SUPERIORITY||Response rate difference|42.5|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|30.7|54.36||||||||54.36|30.70|
91488860|NCT02280304|182849981|OTHER||Cohens d|0.29|||||TWO_SIDED|||||||||||||
91488861|NCT02280304|182849981|OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|||||||||||||
91488862|NCT02280304|182849981|OTHER||Cohens d|0.13|||||TWO_SIDED|||||||||||||
91488863|NCT02280304|182849982|OTHER||Cohens d|0.86|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
91488864|NCT02280304|182849982|OTHER||Cohens d|0.3|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
91488865|NCT02280304|182849983|OTHER||Cohens d|1.32|||||TWO_SIDED||||||||Cohen's d effect size change (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
91488866|NCT02280304|182849983|OTHER||Cohens d|0.27|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
91690252|NCT05906628|183274215|SUPERIORITY||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.14|8.38|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 4||8.38|2.14|<0.0001
91690253|NCT05906628|183274215|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.52|||TWO_SIDED|95.0|16.69|42.24||||||Week 4||42.24|16.69|
91690254|NCT05906628|183274215|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.02|7.51|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||7.51|2.02|<0.0001
91488867|NCT02280304|182849984|SUPERIORITY||||||<|0.0099||||||The p-value obtained for the L PHG seed/L IPL cluster is 0.0099. The critical p-value after Bonferroni correction for multiple seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<.0099
91488868|NCT02280304|182849984|SUPERIORITY||||||<|0.02||||||The p-value obtained for the L anterior PGH seed/left VMPC cluster is 0.02. The critical p-value after Bonferroni correction for six seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<0.02
91488869|NCT02280304|182849985|OTHER||Slope|0.02|||<|3.8e-05|TWO_SIDED|||||Cluster in MPFC p\<0.000038 FDR corrected for multiple comparisons across whole brain. Bonferroni correction for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<.000038
91488870|NCT02280304|182849985|OTHER||Slope|0.02|||<|0.000149|TWO_SIDED|||||Cluster in the right cerebellum (crus 2) p\<0.000149 FDR corrected for multiple comparisons across the whole brain. Bonferroni for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<0.000149
91488871|NCT01935791|182849996|OTHER||||||<|0.01||||||The p-values were adjusted for multiple comparisons. The a priori threshold for statistical significance is p\<0.05.|ANOVA|plus Tukey test||||||<0.01
91488872|NCT01935791|182849997|OTHER||||||<|0.001|||||||ANOVA|plus Tukey test||||||<0.001
91488873|NCT05047770|182850034|NON_INFERIORITY|The non-inferiority was to be concluded if the upper limit (UL) of the 95% confidence interval (CI) of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-gE antibody concentration was below (\<) 1.5.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to HZ/su vaccine administered alone, in terms of anti-gE GMCs, at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group).||1.13|0.89|
91488874|NCT05047770|182850035|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-S protein antibody concentration was \<1.5.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to mRNA-1273 booster dose administered alone, in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both HZ/suSeq and HZ/suCoAd groups).||1.32|0.90|
91690255|NCT05906628|183274215|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|95.0|16.34|42.57||||||Week 16||42.57|16.34|
91690256|NCT05906628|183274216|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1789|TWO_SIDED|95.0|0.718|5.923|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Day 3||5.923|0.718|0.1789
91690257|NCT05906628|183274216|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0024|TWO_SIDED|95.0|1.603|8.951|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 1 (Day 7)||8.951|1.603|0.0024
91690258|NCT05906628|183274217|SUPERIORITY||Odds Ratio (OR)|9.91|||<|0.0001|TWO_SIDED|95.0|4.44|22.13|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||22.13|4.44|<0.0001
91690259|NCT05906628|183274217|SUPERIORITY||Response rate difference|45.6|STANDARD_ERROR_OF_MEAN|6.49|||TWO_SIDED|95.0|32.83|58.27||||||Week 16||58.27|32.83|
91690260|NCT05906628|183274219|SUPERIORITY||Cox regression model|1.719||||0.0025|TWO_SIDED|95.0|1.211|2.44|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.440|1.211|0.0025
91690261|NCT05906628|183274222|SUPERIORITY||Cox regression model|1.279||||0.1319|TWO_SIDED|95.0|0.931|1.759|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||1.759|0.931|0.1319
91690262|NCT01108718|183274236|SUPERIORITY_OR_OTHER||Rate of Preference|0.45|STANDARD_DEVIATION|0.5|>|0.1|TWO_SIDED|95.0|0.43|0.47|||McNemar||Rate of preference refers specifically to Tempur-Pedic Mattress.|h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress||.47|.43|>0.1
91690263|NCT02857816|183274239|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.||||<0.0001
91690264|NCT02443740|183274251|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|39.58|||||TWO_SIDED|90.0|30.14|51.99|||||Values have been back-transformed from the log scale.|||51.99|30.14|
91690265|NCT02443740|183274252|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.6|||||TWO_SIDED|90.0|59.74|108.75|||||Values have been back-transformed from the log scale.|||108.75|59.74|
91690266|NCT02443740|183274253|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.12|||||TWO_SIDED|90.0|58.92|108.94|||||Values have been back-transformed from the log scale.|||108.94|58.92|
91690267|NCT02443740|183274258|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|65.58|||||TWO_SIDED|90.0|62.18|69.16|||||Values have been back-transformed from the log scale.|||69.16|62.18|
91488875|NCT05047770|182850036|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H1N1 influenza strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.18|0.89|
91690268|NCT02443740|183274259|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|68.62|||||TWO_SIDED|90.0|63.27|74.41|||||Values have been back-transformed from the log scale.|||74.41|63.27|
91527172|NCT04424290|182929693|OTHER||Adjusted mean difference|-0.0234|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.0558|0.0089|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0089|-0.0558|
91690269|NCT02443740|183274260|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|29.76|||||TWO_SIDED|90.0|24.17|36.64|||||Values have been back-transformed from the log scale.|||36.64|24.17|
91690270|NCT02443740|183274262|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|16.71|||||TWO_SIDED|90.0|15.35|18.18|||||Values were back-transformed from the log scale.|||18.18|15.35|
91690271|NCT02443740|183274264|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|15.21|||||TWO_SIDED|90.0|13.29|17.42|||||Values were back-transformed from the log scale.|||17.42|13.29|
91690272|NCT02456740|183274398|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.88|-0.92|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.92|-1.88|< 0.001
91690273|NCT02456740|183274398|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.33|-1.37|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.37|-2.33|< 0.001
91690274|NCT02456740|183274399|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.98|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.98|1.52|< 0.001
91690275|NCT02456740|183274399|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|2.01|3.94|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||3.94|2.01|< 0.001
91690276|NCT02456740|183274400|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|LS Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.23|-0.64|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.64|-1.23|< 0.001
91690277|NCT02456740|183274400|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.71|-1.12|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, (stratification factors region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.12|-1.71|< 0.001
91721717|NCT06023563|183335475|OTHER|The required sample size for medium effect size (f = 0.25) and power of 0.80 was calculated to be 6 participants in each group (n =12) (G\*power 3.1.9.7 software). Data were analyzed using IBM SPSS statistical package (version 29.0.1.0).|||||<|0.05|||||||Friedman's test|||A virtual reality active video gaming intervention will be more effective than traditional physical therapy based balance exercises, both based on motor learning principles, in improving static and dynamic balance in youth and young adults with ASD and these improvements will be retained at 4 weeks after the intervention.||||< 0.05
91690278|NCT02456740|183274401|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.51|-1.35|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.35|-3.51|< 0.001
91721718|NCT06023563|183335476|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91721719|NCT06023563|183335477|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91721720|NCT06023563|183335478|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91721721|NCT06023563|183335479|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91690279|NCT02456740|183274401|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.95|-0.77|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.77|-2.95|< 0.001
91690280|NCT02456740|183274402|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.57|||<|0.001|TWO_SIDED|95.0|-3.62|-1.51|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.51|-3.62|< 0.001
91690281|NCT02456740|183274402|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-2.22|||<|0.001|TWO_SIDED|95.0|-3.28|-1.16|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.16|-3.28|< 0.001
91690282|NCT02546986|183274438|SUPERIORITY||Hazard Ratio (HR)|1.374||||0.1789|TWO_SIDED|90.0|0.926|2.038|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.038|0.926|0.1789
91690283|NCT02546986|183274439|SUPERIORITY||Disease Control Rate Difference|-13.3||||0.1572|TWO_SIDED|90.0|-29.0|3.5|||Cochran-Mantel-Haenszel|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma||||3.5|-29.0|0.1572
91690284|NCT02546986|183274440|SUPERIORITY||Hazard Ratio (HR)|1.375||||0.2968|TWO_SIDED|90.0|0.83|2.276|||Stratified Log Rank|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).|Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.|||2.276|0.830|0.2968
91721722|NCT06023563|183335480|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91721723|NCT06023563|183335481|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91721724|NCT06023563|183335482|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
91721725|NCT01928849|183335499|OTHER||Odds Ratio (OR)|0.77||||0.53|TWO_SIDED|95.0|0.34|1.74|||Regression, Logistic|Univariable Logistic regression||||1.74|0.34|0.53
91721726|NCT01928849|183335500|OTHER|||||||0.95|||||||Chi-squared|||Comparison of rate of residual limb pain between treatment groups||||0.95
91721727|NCT01928849|183335500|OTHER|||||||0.74|||||||Chi-squared|||Comparison of rate of Phantom limb pain between treatment groups||||0.74
91721728|NCT01928849|183335501|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 0-24||||0.27
91721729|NCT01928849|183335501|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 24-48||||0.27
91721730|NCT01928849|183335502|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI average pain score||||0.59
91721731|NCT01928849|183335502|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI Interference question sum||||0.16
91721732|NCT01928849|183335503|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
91721733|NCT01928849|183335504|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS numeric pain score||||0.42
91721734|NCT01928849|183335504|OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS supplemental question sum||||0.19
91721735|NCT01928849|183335505|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 0-24||||0.27
91721736|NCT01928849|183335505|OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 24-48||||0.26
91721737|NCT03483103|183335507|SUPERIORITY||||||<|0.0001||||||One sided P-value is calculated based on the null hypothesis ORR \<= 50.2%|Exact binomial test|||||||<.0001
91488876|NCT05047770|182850036|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H3N2 influenza strain.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.05|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.05|0.82|
91690285|NCT02546986|183274441|SUPERIORITY||Overall Response Rate (ORR) Difference|5.3|||||TWO_SIDED|90.0|-11.5|21.3|||||The 90% exact unconditional confidence interval was used for ORR difference.|||21.3|-11.5|
91690286|NCT02546986|183274443|SUPERIORITY||Hazard Ratio (HR)|1.352||||0.199|TWO_SIDED|90.0|0.914|2.0|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.000|0.914|0.1990
91690287|NCT03349060|183274455|SUPERIORITY||Difference in Percentage|15.8||||0.0037|TWO_SIDED|95.0|6.8|24.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.8|6.8|0.0037
91690288|NCT03349060|183274455|SUPERIORITY||Difference in Percentage|36.0|||<|0.0001|TWO_SIDED|95.0|26.2|45.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.7|26.2|<0.0001
91488877|NCT05047770|182850036|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Victoria lineage influenza strain.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.14|0.89|
91690289|NCT03349060|183274456|SUPERIORITY||Difference in Percentage|27.9|||<|0.0001|TWO_SIDED|95.0|17.4|38.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.3|17.4|<0.0001
91690290|NCT03349060|183274456|SUPERIORITY||Difference in Percentage|51.0|||<|0.0001|TWO_SIDED|95.0|40.5|61.5|||Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.5|40.5|<0.0001
91690291|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|18.0||||0.0004|TWO_SIDED|95.0|10.2|25.8|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.8|10.2|0.0004
91690292|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|42.5|||<|0.0001|TWO_SIDED|95.0|33.6|51.4|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||51.4|33.6|<0.0001
91690293|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|15.0||||0.0251|TWO_SIDED|95.0|1.9|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|1.9|0.0251
91690294|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|41.1|||<|0.0001|TWO_SIDED|95.0|27.8|54.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||54.4|27.8|<0.0001
91690295|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|20.0||||0.0019|TWO_SIDED|95.0|7.4|32.7|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||32.7|7.4|0.0019
91690296|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|45.3|||<|0.0001|TWO_SIDED|95.0|32.7|57.8|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.8|32.7|<0.0001
91690297|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|22.5||||0.0003|TWO_SIDED|95.0|10.3|34.8|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||34.8|10.3|0.0003
91690298|NCT03349060|183274457|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|29.6|53.9|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.9|29.6|<0.0001
91690299|NCT03349060|183274458|SUPERIORITY||Difference in Percentage|16.3||||0.0055|TWO_SIDED|95.0|7.4|25.2|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.2|7.4|0.0055
91488878|NCT05047770|182850036|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Yamagata lineage influenza strain.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.93|1.17|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Yamagata lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.17|0.93|
91690300|NCT03349060|183274458|SUPERIORITY||Difference in Percentage|43.3|||<|0.0001|TWO_SIDED|95.0|33.1|53.6|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.6|33.1|<0.0001
91690301|NCT03349060|183274458|SUPERIORITY||Difference in Percentage|12.5||||0.1138|TWO_SIDED|95.0|-3.0|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|-3.0|0.1138
91527173|NCT04424290|182929694|OTHER||Adjusted mean difference|0.0215|STANDARD_ERROR_OF_MEAN|0.0429|||TWO_SIDED|95.0|-0.067|0.11|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1100|-0.0670|
91690302|NCT03349060|183274458|SUPERIORITY||Difference in Percentage|41.8|||<|0.0001|TWO_SIDED|95.0|26.2|57.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.4|26.2|<0.0001
91690303|NCT03349060|183274458|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|15.3|42.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||42.1|15.3|<0.0001
91690304|NCT03349060|183274458|SUPERIORITY||Difference in Percentage|47.8|||<|0.0001|TWO_SIDED|95.0|34.6|61.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||61.1|34.6|<0.0001
91690305|NCT03349060|183274459|SUPERIORITY||Difference in least squares (LS) mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.4|<0.0001
91690306|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-2.0|<0.0001
91690307|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.6|<0.0001
91690308|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-2.8|<0.0001
91690309|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-0.9||||0.0035|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.5|0.0035
91690310|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.3|-2.5|<0.0001
91690311|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-1.1||||0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0010
91690312|NCT03349060|183274459|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.7|<0.0001
91690313|NCT03349060|183274460|SUPERIORITY||Difference in LS mean|-1.3||||0.0002|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0002
91690314|NCT03349060|183274460|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.6|-3.0|<0.0001
91690315|NCT03349060|183274461|SUPERIORITY|||||||0.0071||||||P-value was controlled by randomization strata.|Log Rank|||||||0.0071
91690316|NCT03349060|183274461|SUPERIORITY||||||<|0.0001||||||P-value was controlled by randomization strata.|Log Rank|||||||<0.0001
91690317|NCT03349060|183274462|SUPERIORITY||Difference in Percentage|6.5||||0.0869|TWO_SIDED|95.0|-0.3|13.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.3|-0.3|0.0869
91690318|NCT03349060|183274462|SUPERIORITY||Difference in Percentage|20.3||||0.0001|TWO_SIDED|95.0|12.0|28.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.6|12.0|0.0001
91690319|NCT03349060|183274462|SUPERIORITY||Difference in Percentage|13.1||||0.0259|TWO_SIDED|95.0|2.6|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|2.6|0.0259
91690320|NCT03349060|183274462|SUPERIORITY||Difference in Percentage|33.0|||<|0.0001|TWO_SIDED|95.0|21.7|44.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.2|21.7|<0.0001
91488879|NCT05047770|182850037|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-S antibody concentration was \<1.5.|GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when co-administered with Flu D-QIV vaccine compared to mRNA-1273 booster dose administered alone in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups).||1.13|0.84|
91527174|NCT04424290|182929695|OTHER||Adjusted mean difference|-0.0109|STANDARD_ERROR_OF_MEAN|0.0145|||TWO_SIDED|95.0|-0.0412|0.0195|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0195|-0.0412|
91690321|NCT03349060|183274462|SUPERIORITY||Difference in Percentage|25.0||||0.0001|TWO_SIDED|95.0|14.2|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|14.2|0.0001
91690322|NCT03349060|183274462|SUPERIORITY||Difference in Percentage|44.6|||<|0.0001|TWO_SIDED|95.0|33.6|55.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.6|33.6|<0.0001
91690323|NCT03349060|183274463|SUPERIORITY||Difference in Percentage|3.9||||0.0802|TWO_SIDED|95.0|-0.7|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.7|0.0802
91690324|NCT03349060|183274463|SUPERIORITY||Difference in Percentage|9.8||||0.0045|TWO_SIDED|95.0|4.0|15.7||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.7|4.0|0.0045
91690325|NCT03349060|183274463|SUPERIORITY||Difference in Percentage|5.2||||0.1888|TWO_SIDED|95.0|-1.9|12.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.4|-1.9|0.1888
91690326|NCT03349060|183274463|SUPERIORITY||Difference in Percentage|21.7|||<|0.0001|TWO_SIDED|95.0|13.0|30.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.5|13.0|<0.0001
91690327|NCT03349060|183274463|SUPERIORITY||Difference in Percentage|13.8||||0.0071|TWO_SIDED|95.0|5.2|22.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.4|5.2|0.0071
91690328|NCT03349060|183274463|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.8|38.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.7|19.8|<0.0001
91690329|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
91690330|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
91690331|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with event was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
91690332|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
91690333|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|4.6||||0.0592|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0592
91690334|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
91690335|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|7.0||||0.019|TWO_SIDED|95.0|1.7|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.7|0.0190
91690336|NCT03349060|183274464|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
91721738|NCT00149643|183335585|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||Groups' categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.||||<0.05
91527690|NCT01976364|182930494|OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.93|3.07||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.07|-0.93|
91690337|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|13.9|34.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.1|13.9|<0.0001
91690338|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|34.7|<0.0001
91690339|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|21.6|45.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.4|21.6|<0.0001
91690340|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|52.7|||<|0.0001|TWO_SIDED|95.0|41.2|64.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.2|41.2|<0.0001
91690341|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|34.1|||<|0.0001|TWO_SIDED|95.0|21.9|46.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.3|21.9|<0.0001
91690342|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|52.9|||<|0.0001|TWO_SIDED|95.0|41.3|64.6|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.6|41.3|<0.0001
91721739|NCT04666298|183335593|SUPERIORITY||Mean Difference (Net)|-56.6|STANDARD_ERROR_OF_MEAN|3.24|<|0.0001|TWO_SIDED|95.0|-64.2|-49.0||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-49.0|-64.2|<.0001
91721740|NCT04666298|183335593|SUPERIORITY||Mean Difference (Net)|-60.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|95.0|-67.6|-54.3||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-54.3|-67.6|<.0001
91721741|NCT04666298|183335593|SUPERIORITY||Mean Difference (Net)|-65.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-72.0|-58.6||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-58.6|-72.0|<.0001
91721742|NCT00844519|183335609|SUPERIORITY_OR_OTHER|||||||0.17||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.17
91721743|NCT00844519|183335609|SUPERIORITY_OR_OTHER|||||||0.9||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.90
91721744|NCT03329001|183335616|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.855|0.9706|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using analysis of variance (ANOVA) model accounting for sequence, participants nested with sequences, period and treatment.|||0.9706|0.8550|
91721745|NCT03329001|183335617|OTHER||Ratio of geometric least square mean|0.9216|||||TWO_SIDED|90.0|0.8631|0.9841|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||0.9841|0.8631|
91721746|NCT03329001|183335618|OTHER||Ratio of geometric least square mean|0.9483|||||TWO_SIDED|90.0|0.8489|1.0593|||||Relative bioavailability (Cmax\[tablet\]/Cmax\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||1.0593|0.8489|
91721747|NCT03329001|183335623|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-t|Ratio of geometric least square mean|0.9594|||||TWO_SIDED|90.0|0.9199|1.0006|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0006|0.9199|
91721748|NCT03329001|183335624|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-inf|Ratio of geometric least square mean|0.9566|||||TWO_SIDED|90.0|0.9164|0.9986|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||0.9986|0.9164|
91721749|NCT03329001|183335625|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for Cmax|Ratio of geometric least square mean|0.9619|||||TWO_SIDED|90.0|0.9124|1.014|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0140|0.9124|
91721750|NCT03329001|183335630|OTHER||Ratio of geometric least square mean|1.3154|||||TWO_SIDED|90.0|1.1742|1.4735|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4735|1.1742|
91721751|NCT03329001|183335631|OTHER||Ratio of geometric least square mean|1.2771|||||TWO_SIDED|90.0|1.1537|1.4137|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4137|1.1537|
91721752|NCT03329001|183335632|OTHER||Ratio of geometric least square mean|1.1129|||||TWO_SIDED|90.0|0.9408|1.3164|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.3164|0.9408|
91721753|NCT00622518|183335646|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||P value is based on rating\*group interaction term|linear mixed model|||||||.002
91721754|NCT02178956|183335648|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8596|TWO_SIDED|95.0|0.86|1.02||two-sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.02|0.86|0.8596
91721755|NCT02178956|183335649|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9028|TWO_SIDED|95.0|0.85|1.19||two sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucuasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.19|0.85|0.9028
91527175|NCT04424290|182929696|OTHER||Adjusted mean difference|-0.0228|STANDARD_ERROR_OF_MEAN|0.0603|||TWO_SIDED|95.0|-0.1477|0.1021|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1021|-0.1477|
91527691|NCT01976364|182930494|OTHER||LS mean difference|0.38|||||TWO_SIDED|95.0|-1.62|2.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.38|-1.62|
91721756|NCT02178956|183335650|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7359|TWO_SIDED|95.0|0.6|1.44||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.44|0.60|0.7359
91721757|NCT02178956|183335651|SUPERIORITY||Odds Ratio (OR)|0.93||||0.6555|TWO_SIDED|95.0|0.66|1.3||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.30|0.66|0.6555
91721758|NCT03769493|183335654|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||< .001
91721759|NCT03769493|183335655|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||.875
91721760|NCT03282097|183335698|SUPERIORITY|||||||0.4393|||||||ANCOVA|||||||0.4393
91721761|NCT03282097|183335699|SUPERIORITY|||||||0.2262|||||||ANCOVA|||||||.2262
91690343|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|35.3|||<|0.0001|TWO_SIDED|95.0|23.3|47.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.4|23.3|<0.0001
91690344|NCT03349060|183274465|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|42.0|65.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||65.0|42.0|<0.0001
91690345|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|0.6||||0.7285|TWO_SIDED|95.0|-3.9|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-3.9|0.7285
91690346|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|4.0||||0.1448|TWO_SIDED|95.0|-1.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-1.2|0.1448
91690347|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|3.9||||0.2576|TWO_SIDED|95.0|-2.6|10.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.5|-2.6|0.2576
91690348|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|20.4||||0.0001|TWO_SIDED|95.0|12.0|28.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.9|12.0|0.0001
91690349|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|9.0||||0.0423|TWO_SIDED|95.0|1.3|16.8|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.8|1.3|0.0423
91690350|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|18.7|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|18.7|<0.0001
91690351|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|13.3||||0.0066|TWO_SIDED|95.0|5.4|21.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.2|5.4|0.0066
91690352|NCT03349060|183274466|SUPERIORITY||Difference in Percentage|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.3|<0.0001
91690353|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
91690354|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
91527692|NCT01976364|182930495|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5|-0.9|
91690355|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with events was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
91721762|NCT03282097|183335700|SUPERIORITY|||||||0.0023|||||||ANCOVA|||||||0.0023
91690356|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
91690357|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|4.6||||0.0604|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0604
91690358|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
91721763|NCT03282097|183335701|SUPERIORITY|||||||0.6075|||||||Regression, Logistic|||||||0.6075
91721764|NCT03282097|183335702|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<.0001
91721765|NCT03282097|183335703|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
91488880|NCT05047770|182850038|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.6|||||TWO_SIDED|95.0|-5.1|6.4|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||6.4|-5.1|
91488881|NCT05047770|182850038|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.3|||||TWO_SIDED|95.0|-7.8|5.2|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.2|-7.8|
91690359|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|6.4||||0.0255|TWO_SIDED|95.0|1.2|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.2|0.0255
91690360|NCT03349060|183274467|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
91690361|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-5.8|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-8.2|<0.0001
91690362|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.1|-13.0|<0.0001
91690363|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-7.9|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.0|-10.7|<0.0001
91721766|NCT03034967|183335768|OTHER|Emax|Median Posterior Difference|0.08|||||TWO_SIDED|90.0|0.0|0.66|||||Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.66|0.00|
91721767|NCT03034967|183335768|OTHER|Emax|Median Posterior Difference|0.61|||||TWO_SIDED|90.0|0.0|1.52|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||1.52|0.00|
91721768|NCT03034967|183335768|OTHER|Emax|Median Posterior Difference|1.25|||||TWO_SIDED|90.0|0.43|1.97|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.97|0.43|
91690364|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-12.7|||<|0.0001|TWO_SIDED|95.0|-15.6|-9.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.9|-15.6|<0.0001
91690365|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.5|-11.6|<0.0001
91690366|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-13.5|||<|0.0001|TWO_SIDED|95.0|-16.5|-10.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.4|-16.5|<0.0001
91527693|NCT01976364|182930495|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-1.1|2.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.2|-1.1|
91690367|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.1|-11.6|<0.0001
91690368|NCT03349060|183274468|SUPERIORITY||Difference in LS mean|-14.0|||<|0.0001|TWO_SIDED|95.0|-17.3|-10.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.8|-17.3|<0.0001
91690369|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-7.8||||0.0004|TWO_SIDED|95.0|-12.1|-3.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.5|-12.1|0.0004
91721769|NCT03034967|183335768|OTHER|Emax|Median Posterior Difference|1.34|||||TWO_SIDED|90.0|0.72|2.03|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||2.03|0.72|
91721770|NCT03034967|183335768|OTHER|Emax|Median Posterior Difference|1.38|||||TWO_SIDED|90.0|0.79|2.07|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||2.07|0.79|
91488882|NCT05047770|182850038|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.1|||||TWO_SIDED|95.0|-5.8|5.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.9|-5.8|
91690370|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-14.8|||<|0.0001|TWO_SIDED|95.0|-19.0|-10.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.5|-19.0|<0.0001
91690371|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.6|-6.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.9|-16.6|<0.0001
91690372|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-18.5|||<|0.0001|TWO_SIDED|95.0|-23.4|-13.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.6|-23.4|<0.0001
91690373|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.7|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.7|<0.0001
91690374|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-22.6|||<|0.0001|TWO_SIDED|95.0|-28.0|-17.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-28.0|<0.0001
91690375|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.3|-8.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.2|-19.3|<0.0001
91527176|NCT04424290|182929697|OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-8.1|5.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.5|-8.1|
91690376|NCT03349060|183274469|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.6|-16.5|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.5|-27.6|<0.0001
91690377|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|1.3||||0.521|TWO_SIDED|95.0|-3.4|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-3.4|0.5210
91690378|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|4.0||||0.1416|TWO_SIDED|95.0|-1.3|9.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.3|-1.3|0.1416
91690379|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|4.6||||0.2002|TWO_SIDED|95.0|-2.1|11.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.2|-2.1|0.2002
91690380|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|23.6|||<|0.0001|TWO_SIDED|95.0|15.1|32.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.2|15.1|<0.0001
91690381|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|9.6||||0.0434|TWO_SIDED|95.0|1.3|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|1.3|0.0434
91690382|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|26.6|||<|0.0001|TWO_SIDED|95.0|17.1|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|17.1|<0.0001
91690383|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|15.8||||0.0019|TWO_SIDED|95.0|7.5|24.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.0|7.5|0.0019
91721771|NCT03034967|183335769|OTHER|Emax|Median Posterior Difference|0.09|||||TWO_SIDED|90.0|0.0|0.42|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.42|0.00|
91721772|NCT03034967|183335769|OTHER|Emax|Median Posterior Difference|0.43|||||TWO_SIDED|90.0|0.0|0.87|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.87|0.00|
91527177|NCT04424290|182929698|OTHER||Adjusted mean difference|4.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.3|16.2|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.2|-7.3|
91690384|NCT03349060|183274470|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|24.0|42.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.7|24.0|<0.0001
91690385|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|10.8||||0.0151|TWO_SIDED|95.0|3.3|18.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.3|3.3|0.0151
91690386|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.0|<0.0001
91690387|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|21.2||||0.001|TWO_SIDED|95.0|10.2|32.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.3|10.2|0.0010
91690388|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|37.9|||<|0.0001|TWO_SIDED|95.0|26.6|49.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.3|26.6|<0.0001
91690389|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|23.5||||0.0003|TWO_SIDED|95.0|12.6|34.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.3|12.6|0.0003
91690390|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|30.7|52.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||52.7|30.7|<0.0001
91690391|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|19.6||||0.0026|TWO_SIDED|95.0|8.1|31.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.1|8.1|0.0026
91690392|NCT03349060|183274471|SUPERIORITY||Difference in Percentage|40.0|||<|0.0001|TWO_SIDED|95.0|28.3|51.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||51.7|28.3|<0.0001
91690393|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|1.3||||0.3151|TWO_SIDED|95.0|-2.9|5.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.6|-2.9|0.3151
91690394|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|6.0||||0.0292|TWO_SIDED|95.0|0.7|11.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.3|0.7|0.0292
91690395|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|-0.2||||0.9402|TWO_SIDED|95.0|-5.9|5.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.5|-5.9|0.9402
91690396|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|15.3||||0.0019|TWO_SIDED|95.0|7.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|7.3|0.0019
91690397|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|10.8||||0.0078|TWO_SIDED|95.0|4.2|17.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.4|4.2|0.0078
91690398|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.2|30.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.1|14.2|<0.0001
91690399|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|8.2||||0.0528|TWO_SIDED|95.0|1.0|15.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.3|1.0|0.0528
91690400|NCT03349060|183274472|SUPERIORITY||Difference in Percentage|26.4|||<|0.0001|TWO_SIDED|95.0|17.6|35.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.3|17.6|<0.0001
91690401|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.9|<0.0001
91690402|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-3.0|<0.0001
91690403|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.2|<0.0001
91721773|NCT03034967|183335769|OTHER|Emax|Median Posterior Difference|0.68|||||TWO_SIDED|90.0|0.23|1.08|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.08|0.23|
91721774|NCT03034967|183335769|OTHER|Emax|Median Posterior Difference|0.72|||||TWO_SIDED|90.0|0.37|1.1|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||1.10|0.37|
91721775|NCT03034967|183335769|OTHER|Emax|Median Posterior Difference|0.73|||||TWO_SIDED|90.0|0.4|1.12|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||1.12|0.40|
91721776|NCT03034967|183335770|OTHER|Emax|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|0.0|0.16|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.16|0.00|
91721777|NCT03034967|183335770|OTHER|Emax|Median Posterior Difference|0.12|||||TWO_SIDED|90.0|0.0|0.43|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.43|0.00|
91721778|NCT03034967|183335770|OTHER|Emax|Median Posterior Difference|0.38|||||TWO_SIDED|90.0|0.04|0.61|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||0.61|0.04|
91527694|NCT01976364|182930495|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.4|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-2.4|
91690404|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-3.4|<0.0001
91690405|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-2.3|<0.0001
91690406|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.8|-3.2|<0.0001
91721779|NCT03034967|183335770|OTHER|Emax|Median Posterior Difference|0.42|||||TWO_SIDED|90.0|0.21|0.64|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||0.64|0.21|
91690407|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.1|0.0005
91690408|NCT03349060|183274473|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.9|<0.0001
91690409|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-10.9|||<|0.0001|TWO_SIDED|95.0|-14.8|-7.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.0|-14.8|<0.0001
91721780|NCT03034967|183335770|OTHER|Emax|Median Posterior Difference|0.45|||||TWO_SIDED|90.0|0.26|0.66|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||0.66|0.26|
91721781|NCT03034967|183335771|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.21|0.23|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|Log-linear model.||0.23|-0.21|
91721782|NCT03034967|183335771|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.23|0.25|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|Log-linear model||0.25|-0.23|
91721783|NCT03034967|183335771|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.27|0.29|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|Log-linear model||0.29|-0.27|
91721784|NCT03034967|183335771|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.28|0.3|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|Log-linear model||0.30|-0.28|
91721785|NCT03034967|183335771|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.29|0.31|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|Log-linear model||0.31|-0.29|
91721786|NCT03034967|183335778|OTHER||Odds Ratio (OR)|1.71||||0.089|TWO_SIDED|90.0|1.02|2.86||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.86|1.02|0.089
91721787|NCT03034967|183335778|OTHER||Odds Ratio (OR)|1.05||||0.881|TWO_SIDED|90.0|0.62|1.79||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.79|0.62|0.881
91690410|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-18.9|||<|0.0001|TWO_SIDED|95.0|-22.7|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-22.7|<0.0001
91690411|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.8|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.8|-17.3|<.0001
91690412|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-22.1|||<|0.0001|TWO_SIDED|95.0|-26.8|-17.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-26.8|<.0001
91690413|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.5|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.5|<.0001
91721788|NCT03034967|183335778|OTHER||Odds Ratio (OR)|0.87||||0.674|TWO_SIDED|90.0|0.51|1.48||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.48|0.51|0.674
91721789|NCT03034967|183335778|OTHER||Odds Ratio (OR)|0.92||||0.804|TWO_SIDED|90.0|0.54|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||1.58|0.54|0.804
91721790|NCT03034967|183335778|OTHER||Odds Ratio (OR)|1.01||||0.987|TWO_SIDED|90.0|0.59|1.71||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.71|0.59|0.987
91488883|NCT05047770|182850038|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.6|||||TWO_SIDED|95.0|-7.0|3.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||3.9|-7.0|
91488884|NCT01952145|182850095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDegLira versus IGlar was considered as confirmed, if the 95% confidence interval (CI) for the mean treatment difference was entirely below 0.30%.|Treatment contrast|-0.59|||<|0.001|TWO_SIDED|95.0|-0.74|-0.45|||ANCOVA|||This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.||-0.45|-0.74|< 0.001
91690414|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-27.2|<.0001
91690415|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-13.3|||<|0.0001|TWO_SIDED|95.0|-19.0|-7.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.7|-19.0|<0.0001
91690416|NCT03349060|183274474|SUPERIORITY||Difference in LS mean|-21.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-16.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.3|-27.5|<.0001
91690417|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|22.3||||0.0028|TWO_SIDED|95.0|8.7|35.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.9|8.7|0.0028
91488885|NCT02130570|182850110|SUPERIORITY||Incidence rate ratio|0.52||||0.02|TWO_SIDED|95.0|0.3|0.91||This is the P-value for the adjusted IRR.|Regression poissant|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.91|0.30|0.02
91488886|NCT02130570|182850111|SUPERIORITY||Incidence rate ratio|0.78||||0.01|TWO_SIDED|95.0|0.64|0.95||This is the p-value for the adjusted rate|Regression poissant|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.95|0.64|0.01
91488887|NCT02130570|182850112|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.64|1.85||This is the P-value for the adjusted Odds Ratio|Regression, Logistic|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect . OR: odds ratio|1.85|0.64|0.77
91690418|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|40.1|||<|0.0001|TWO_SIDED|95.0|27.1|53.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.2|27.1|<0.0001
91690419|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|17.1||||0.0217|TWO_SIDED|95.0|2.8|31.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.4|2.8|0.0217
91690420|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|32.2|||<|0.0001|TWO_SIDED|95.0|18.5|45.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.9|18.5|<0.0001
91721791|NCT03034967|183335780|OTHER||Median Posterior Hazard Ratio|1.2|||||TWO_SIDED|90.0|0.5|2.6|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.|2.6|0.5|
91721792|NCT03034967|183335780|OTHER||Median Posterior Hazard Ratio|1.0|||||TWO_SIDED|90.0|0.4|2.4|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.4|0.4|
91721793|NCT03034967|183335780|OTHER||Median Posterior Hazard Ratio|1.4|||||TWO_SIDED|90.0|0.6|3.2|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|3.2|0.6|
91488888|NCT02130570|182850113|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|||||This is the P-value for the adjusted difference.|Regression, Linear|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect.|||0.91
91488889|NCT02130570|182850114|SUPERIORITY||Odds Ratio, log|0.85||||0.57|TWO_SIDED|95.0|0.47|1.51||"Please see the Other Statistical Analysis field for adjustments and the P-value computed for each survey question."|Regression, Logistic||"Please see the Other Statistical Analysis field for a list of the estimated value and 95% CI for each survey question."||"Please see the Other Statistical Analysis field for adjustments."|1.51|0.47|0.57
91721794|NCT03034967|183335780|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|1.0|4.3|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.3|1.0|
91488890|NCT05981391|182850120|SUPERIORITY|||||||0.01||||||Adjusted for multiple comparisons.|t-test, 2 sided|||||||0.01
91527178|NCT04424290|182929699|OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.6|3.0|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.0|-9.6|
91690421|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|15.7||||0.0363|TWO_SIDED|95.0|1.4|30.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.0|1.4|0.0363
91527179|NCT04424290|182929700|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.3|6.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||6.1|-7.3|
91690422|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|23.7||||0.0011|TWO_SIDED|95.0|9.8|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|9.8|0.0011
91690423|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|20.1||||0.008|TWO_SIDED|95.0|5.8|34.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.5|5.8|0.0080
91690424|NCT03349060|183274475|SUPERIORITY||Difference in Percentage|29.1|||<|0.0001|TWO_SIDED|95.0|15.0|43.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|15.0|<0.0001
91690425|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.2|-5.4|<0.0001
91690426|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.9|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.9|-7.1|<0.0001
91690427|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-3.3||||0.0001|TWO_SIDED|95.0|-5.0|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-5.0|0.0001
91690428|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.8|-4.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.5|-7.8|<.0001
91690429|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-2.8||||0.0075|TWO_SIDED|95.0|-4.8|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.8|0.0075
91690430|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-7.4|<0.0001
91690431|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-2.8||||0.0072|TWO_SIDED|95.0|-4.8|-0.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-4.8|0.0072
91690432|NCT03349060|183274476|SUPERIORITY||Difference in LS mean|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.9|-6.9|<0.0001
91690433|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-1.3||||0.275|TWO_SIDED|95.0|-3.5|1.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||1.0|-3.5|0.2750
91690434|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-2.5||||0.028|TWO_SIDED|95.0|-4.8|-0.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-4.8|0.0280
91690435|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-3.5||||0.0051|TWO_SIDED|95.0|-5.9|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-5.9|0.0051
91690436|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-6.4|||<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.0|-8.8|<0.0001
91690437|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-2.1||||0.1706|TWO_SIDED|95.0|-5.1|0.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.9|-5.1|0.1706
91690438|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-7.4|0.0048
91690439|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-2.5||||0.0629|TWO_SIDED|95.0|-5.2|0.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.1|-5.2|0.0629
91690440|NCT03349060|183274477|SUPERIORITY||Difference in LS mean|-3.6||||0.01|TWO_SIDED|95.0|-6.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-6.2|0.0100
91690441|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|6.6||||0.1238|TWO_SIDED|95.0|-0.7|13.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.9|-0.7|0.1238
91690442|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|20.1||||0.0008|TWO_SIDED|95.0|11.0|29.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.2|11.0|0.0008
91690443|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|6.8||||0.2091|TWO_SIDED|95.0|-2.8|16.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.4|-2.8|0.2091
91690444|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|24.0||||0.0005|TWO_SIDED|95.0|12.9|35.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.0|12.9|0.0005
91690445|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|9.1||||0.1161|TWO_SIDED|95.0|-0.9|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-0.9|0.1161
91690446|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|26.5||||0.0002|TWO_SIDED|95.0|15.3|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|15.3|0.0002
91721795|NCT03034967|183335780|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|0.9|4.5|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.5|0.9|
91721796|NCT03034967|183335783|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|1.0|2.2|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.|2.2|1.0|
91690447|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|8.1||||0.1837|TWO_SIDED|95.0|-2.8|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-2.8|0.1837
91690448|NCT03349060|183274478|SUPERIORITY||Difference in Percentage|19.8||||0.0046|TWO_SIDED|95.0|8.1|31.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.6|8.1|0.0046
91690449|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|3.2||||0.4795|TWO_SIDED|95.0|-10.3|16.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.6|-10.3|0.4795
91690450|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.7|-12.7|
91690451|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|13.3||||0.1452|TWO_SIDED|95.0|-3.6|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|-3.6|0.1452
91690452|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
91721797|NCT03034967|183335783|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.8|1.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.7|0.8|
91489407|NCT02484690|182851585|SUPERIORITY||Difference in Least Squares Means|-0.78||||0.4353|TWO_SIDED|80.0|-2.07|0.51||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.51|-2.07|0.4353
91690453|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|5.8||||0.5707|TWO_SIDED|95.0|-13.7|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-13.7|0.5707
91690454|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|5.8||||0.5777|TWO_SIDED|95.0|-13.6|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-13.6|0.5777
91690455|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|19.3||||0.0744|TWO_SIDED|95.0|1.0|37.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.5|1.0|0.0744
91690456|NCT03349060|183274479|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
91690457|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|17.2|46.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.0|17.2|<0.0001
91690458|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|35.7|||<|0.0001|TWO_SIDED|95.0|21.5|49.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.9|21.5|<0.0001
91721798|NCT03034967|183335783|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.6|0.7|
91721799|NCT03034967|183335783|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.4|||||TWO_SIDED|90.0|1.0|2.1|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.1|1.0|
91690459|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|20.4||||0.009|TWO_SIDED|95.0|5.2|35.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.6|5.2|0.0090
91690460|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|19.0|47.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.7|19.0|<0.0001
91690461|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|16.5||||0.0421|TWO_SIDED|95.0|0.6|32.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.4|0.6|0.0421
91690462|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|33.8|||<|0.0001|TWO_SIDED|95.0|18.9|48.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.8|18.9|<0.0001
91690463|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|23.5||||0.0035|TWO_SIDED|95.0|8.2|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|8.2|0.0035
91721800|NCT03034967|183335783|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.1|2.3|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.3|1.1|
91488891|NCT03072732|182850136|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 1 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.75|0.57|
91488892|NCT03072732|182850136|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.12|0.35|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 2 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.35|0.12|
91488893|NCT04889222|182850141|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0.00097||||||The a priori threshold for p-value was 0.05.|Two One Sided Tests (TOST)|||||||0.00097
91488894|NCT04889222|182850142|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0||||||The a priori threshold for p-value was 0.05.|Two One-Sided Tests (TOST)|||||||0.00000
91488895|NCT01044706|182850149|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|108.46|STANDARD_ERROR_OF_MEAN|0.0321|<|0.05|TWO_SIDED|90.0|102.79|114.44||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 55|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.||114.44|102.79|<0.05
91690464|NCT03349060|183274480|SUPERIORITY||Difference in Percentage|28.8||||0.0002|TWO_SIDED|95.0|13.8|43.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.9|13.8|0.0002
91690465|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|17.1||||0.2497|TWO_SIDED|95.0|-9.1|43.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.2|-9.1|0.2497
91690466|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|17.1||||0.2371|TWO_SIDED|95.0|-9.0|43.3|||Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|-9.0|0.2371
91489408|NCT02484690|182851585|SUPERIORITY||Difference in Least Squares Means|1.45||||0.1652|TWO_SIDED|80.0|0.11|2.78||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.78|0.11|0.1652
91690467|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|28.8||||0.0697|TWO_SIDED|95.0|-0.8|58.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.3|-0.8|0.0697
91690468|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|43.9||||0.003|TWO_SIDED|95.0|16.2|71.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.7|16.2|0.0030
91690469|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|31.0||||0.0583|TWO_SIDED|95.0|2.0|59.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.9|2.0|0.0583
91690470|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|41.2||||0.0085|TWO_SIDED|95.0|13.2|69.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||69.1|13.2|0.0085
91690471|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|19.3||||0.1948|TWO_SIDED|95.0|-9.8|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-9.8|0.1948
91690472|NCT03349060|183274481|SUPERIORITY||Difference in Percentage|30.6||||0.0296|TWO_SIDED|95.0|2.8|58.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.5|2.8|0.0296
91690473|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.1|0.1718
91690474|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-1.1||||0.0018|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0018
91690475|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0005
91690476|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-2.5|<0.0001
91690477|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-0.7||||0.0476|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.5|0.0476
91721801|NCT03034967|183335784|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.5|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.5|0.7|
91721802|NCT03034967|183335784|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.9|||||TWO_SIDED|90.0|0.7|5.8|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.8|0.7|
91690478|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.0|-2.4|<0.0001
91690479|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-1.1||||0.0028|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.9|0.0028
91690480|NCT03349060|183274482|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.3|<0.0001
91690481|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-0.2||||0.6134|TWO_SIDED|95.0|-0.9|0.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.5|-0.9|0.6134
91690482|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-0.7||||0.0422|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.4|0.0422
91690483|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-0.5||||0.205|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2050
91721803|NCT03034967|183335784|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.6|0.7|
91721804|NCT03034967|183335784|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|2.3|||||TWO_SIDED|90.0|0.9|6.9|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|6.9|0.9|
91690484|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-1.2||||0.0012|TWO_SIDED|95.0|-1.9|-0.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-1.9|0.0012
91690485|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-0.4||||0.2657|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2657
91690486|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-1.2||||0.0019|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-2.0|0.0019
91690487|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-0.5||||0.1675|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.3|0.1675
91690488|NCT03349060|183274483|SUPERIORITY||Difference in LS mean|-1.0||||0.0085|TWO_SIDED|95.0|-1.8|-0.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.8|0.0085
91690489|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|8.8||||0.5539|TWO_SIDED|95.0|-19.6|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|-19.6|0.5539
91690490|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|27.9||||0.0561|TWO_SIDED|95.0|0.8|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|0.8|0.0561
91721805|NCT03034967|183335784|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.2|2.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.7|0.2|
91721806|NCT03034967|183335787|OTHER||Odds Ratio (OR)|1.51||||0.208|TWO_SIDED|90.0|0.88|2.59||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.59|0.88|0.208
91721807|NCT03034967|183335787|OTHER||Odds Ratio (OR)|1.27||||0.482|TWO_SIDED|90.0|0.73|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||2.20|0.73|0.482
91489409|NCT02484690|182851585|SUPERIORITY||Difference in Least Squares Means|0.5||||0.61111|TWO_SIDED|80.0|-0.76|1.75||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.75|-0.76|0.61111
91690491|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|-4.9||||0.746|TWO_SIDED|95.0|-33.4|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-33.4|0.7460
91690492|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|0.0||||1|TWO_SIDED|95.0|-28.3|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|-28.3|1.0000
91690493|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|20.8||||0.1474|TWO_SIDED|95.0|-4.5|46.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.2|-4.5|0.1474
91690494|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|37.3||||0.0123|TWO_SIDED|95.0|12.1|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|12.1|0.0123
91690495|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|-0.4||||0.976|TWO_SIDED|95.0|-28.5|27.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.6|-28.5|0.9760
91488896|NCT01044706|182850150|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|110.5|STANDARD_ERROR_OF_MEAN|0.0281|<|0.05|TWO_SIDED|95.0|105.43|115.82||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 56|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.||115.82|105.43|<0.05
91488897|NCT02478372|182850197|SUPERIORITY_OR_OTHER|||||||0.332|TWO_SIDED|||||Significance was set at \<0.01|Chi-squared|||||||0.332
91488898|NCT00116428|182850206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.||||<0.001
91527695|NCT01976364|182930495|OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.8|2.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.9|-0.8|
91690496|NCT03349060|183274484|SUPERIORITY||Difference in Percentage|7.8||||0.5965|TWO_SIDED|95.0|-20.4|36.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.1|-20.4|0.5965
91690497|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|24.0||||0.2278|TWO_SIDED|95.0|-9.9|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|-9.9|0.2278
91690498|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|35.2||||0.0996|TWO_SIDED|95.0|-2.0|72.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||72.4|-2.0|0.0996
91721808|NCT03034967|183335787|OTHER||Odds Ratio (OR)|1.47||||0.239|TWO_SIDED|90.0|0.86|2.53||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||2.53|0.86|0.239
91488899|NCT01032174|182850211|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||<0.0001
91488900|NCT01032174|182850212|SUPERIORITY_OR_OTHER||Difference of Least Square Mean|1.06|STANDARD_ERROR_OF_MEAN|0.55||0.0568|TWO_SIDED|95.0|-0.03|2.15||The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).|ANCOVA|Least square mean was adjusted for gender, age and BMI.||||2.15|-0.03|0.0568
91690499|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|14.5||||0.4449|TWO_SIDED|95.0|-21.6|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|-21.6|0.4449
91690500|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|16.9||||0.4139|TWO_SIDED|95.0|-21.6|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|-21.6|0.4139
91721809|NCT03034967|183335787|OTHER||Odds Ratio (OR)|1.31||||0.426|TWO_SIDED|90.0|0.75|2.26||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.26|0.75|0.426
91488901|NCT01032174|182850213|SUPERIORITY_OR_OTHER|||||||0.0682|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||0.0682
91488902|NCT00113087|182850214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.28|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.28
91488903|NCT00113087|182850215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.42||95.0|||||Mixed Models Analysis|||||||0.42
91488904|NCT00113087|182850216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
91488905|NCT00113087|182850217|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91488906|NCT00113087|182850218|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Fisher Exact|||||||0.71
91488907|NCT00113087|182850219|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
91488908|NCT00113087|182850220|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.22
91527696|NCT01976364|182930495|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-1.1|2.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.6|-1.1|
91690501|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|-6.7||||0.729|TWO_SIDED|95.0|-40.7|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|-40.7|0.7290
91690502|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|8.7||||0.6585|TWO_SIDED|95.0|-27.3|44.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.6|-27.3|0.6585
91690503|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|18.2||||0.3638|TWO_SIDED|95.0|-18.7|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|-18.7|0.3638
91690504|NCT03349060|183274485|SUPERIORITY||Difference in Percentage|40.5||||0.055|TWO_SIDED|95.0|2.4|78.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||78.5|2.4|0.0550
91690505|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
91690506|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|-35.3||||0.158|TWO_SIDED|95.0|-75.9|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-75.9|0.1580
91690507|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|-14.2||||0.514|TWO_SIDED|95.0|-53.5|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-53.5|0.5140
91690508|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|-19.8||||0.4149|TWO_SIDED|95.0|-63.3|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-63.3|0.4149
91690509|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
91690510|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|-30.7||||0.2092|TWO_SIDED|95.0|-70.9|9.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.6|-70.9|0.2092
91690511|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|11.9||||0.5982|TWO_SIDED|95.0|-29.1|53.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.0|-29.1|0.5982
91690512|NCT03349060|183274486|SUPERIORITY||Difference in Percentage|4.2||||0.8647|TWO_SIDED|95.0|-36.3|44.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.7|-36.3|0.8647
91690513|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|-78.6||||0.0546|TWO_SIDED|95.0|-117.5|-39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||-39.6|-117.5|0.0546
91690514|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|-27.9||||0.3573|TWO_SIDED|95.0|-62.5|6.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.7|-62.5|0.3573
91690515|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|-3.6||||0.9219|TWO_SIDED|95.0|-55.6|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-55.6|0.9219
91690516|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
91527180|NCT04424290|182929701|OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-8.7|3.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.1|-8.7|
91690517|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
91488909|NCT00113087|182850221|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||0.86
91488910|NCT00113087|182850222|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
91527181|NCT04424290|182929702|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-4.9|5.4|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.4|-4.9|
91690518|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
91690519|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
91690520|NCT03349060|183274487|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
91690521|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-2.8||||0.0006|TWO_SIDED|95.0|-4.4|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-4.4|0.0006
91690522|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.9|-4.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-7.9|<0.0001
91690523|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.6|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-5.6|<0.0001
91721810|NCT03034967|183335787|OTHER||Odds Ratio (OR)|0.9||||0.763|TWO_SIDED|90.0|0.52|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.58|0.52|0.763
91690524|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.2|-6.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.6|-10.2|<0.0001
91690525|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.7|0.0096
91690526|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-7.2|||<|0.0001|TWO_SIDED|95.0|-9.3|-5.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.2|-9.3|<0.0001
91721811|NCT03034967|183335789|OTHER||Odds Ratio (OR)|1.01||||0.973|TWO_SIDED|90.0|0.58|1.76||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||1.76|0.58|0.973
91488911|NCT00113087|182850223|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
91488912|NCT00113087|182850224|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
91488913|NCT00113087|182850225|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
91488914|NCT00113087|182850226|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91488915|NCT00113087|182850227|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
91488916|NCT00113087|182850228|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
91488917|NCT00113087|182850229|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||||||0.37
91488918|NCT00113087|182850230|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
91488919|NCT00113087|182850231|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
91488920|NCT00113087|182850232|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
91721812|NCT03034967|183335789|OTHER||Odds Ratio (OR)|0.93||||0.825|TWO_SIDED|90.0|0.53|1.63||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.63|0.53|0.825
91690527|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-3.1||||0.0049|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-5.2|0.0049
91721813|NCT03034967|183335789|OTHER||Odds Ratio (OR)|0.95||||0.887|TWO_SIDED|90.0|0.55|1.66||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.66|0.55|0.887
91690528|NCT03349060|183274488|SUPERIORITY||Difference in LS mean|-6.9|||<|0.0001|TWO_SIDED|95.0|-9.0|-4.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-9.0|<0.0001
91690529|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.4||||0.002|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.1|-0.6|0.0020
91690530|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.0|<0.0001
91690531|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.5||||0.0011|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.7|0.0011
91690532|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-1.2|<0.0001
91690533|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.5||||0.002|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0020
91690534|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.2|<0.0001
91690535|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.5||||0.0014|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0014
91690536|NCT03349060|183274489|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.3|<0.0001
91690537|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|6.0||||0.0575|TWO_SIDED|95.0|0.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|0.3|0.0575
91721814|NCT03034967|183335789|OTHER||Odds Ratio (OR)|1.21||||0.567|TWO_SIDED|90.0|0.69|2.13||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.13|0.69|0.567
91721815|NCT03034967|183335789|OTHER||Odds Ratio (OR)|1.26||||0.501|TWO_SIDED|90.0|0.72|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||2.20|0.72|0.501
91488921|NCT00113087|182850233|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
91488922|NCT00113087|182850234|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
91488923|NCT00113087|182850235|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
91488924|NCT00113087|182850236|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||||||0.62
91488925|NCT00113087|182850237|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
91488926|NCT00113087|182850238|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
91488927|NCT00113087|182850239|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||t-test, 2 sided|||||||0.34
91488928|NCT00113087|182850240|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||.81
91488929|NCT00113087|182850241|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
91488930|NCT00113087|182850242|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.06
91488931|NCT02713204|182850251|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|0.02||||0.9894|TWO_SIDED|95.0|-2.99|3.03||Threshold for significance at 0.05 level.|ANCOVA|||||3.03|-2.99|0.9894
91690538|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|18.1||||0.0002|TWO_SIDED|95.0|10.7|25.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.5|10.7|0.0002
91690539|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|9.2||||0.0411|TWO_SIDED|95.0|1.3|17.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.1|1.3|0.0411
91488932|NCT02713204|182850251|SUPERIORITY||Least square mean difference|0.25||||0.8346|TWO_SIDED|95.0|-2.09|2.59|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.59|-2.09|0.8346
91690540|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.9|35.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.5|16.9|<0.0001
91690541|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|8.9||||0.0781|TWO_SIDED|95.0|-0.1|18.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.0|-0.1|0.0781
91690542|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.2|36.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.3|16.2|<0.0001
91690543|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|14.2||||0.0075|TWO_SIDED|95.0|5.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|5.3|0.0075
91690544|NCT03349060|183274490|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.6|38.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.9|19.6|<0.0001
91690545|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.034||||0.0453|TWO_SIDED|95.0|0.001|0.066|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.066|0.001|0.0453
91690546|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.068|||<|0.0001|TWO_SIDED|95.0|0.036|0.101|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.101|0.036|<0.0001
91690547|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.025||||0.1821|TWO_SIDED|95.0|-0.012|0.062|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.062|-0.012|0.1821
91690548|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.055||||0.0038|TWO_SIDED|95.0|0.018|0.092|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.092|0.018|0.0038
91690549|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.048||||0.0241|TWO_SIDED|95.0|0.006|0.09|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.090|0.006|0.0241
91690550|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.093|||<|0.0001|TWO_SIDED|95.0|0.051|0.134|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.134|0.051|<0.0001
91690551|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.044||||0.0461|TWO_SIDED|95.0|0.001|0.087|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.087|0.001|0.0461
91690552|NCT03349060|183274491|SUPERIORITY||Difference in LS mean|0.064||||0.0037|TWO_SIDED|95.0|0.021|0.107|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.107|0.021|0.0037
91690553|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|4.548||||0.0319|TWO_SIDED|95.0|0.397|8.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||8.700|0.397|0.0319
91488933|NCT02713204|182850252|SUPERIORITY||Least square mean difference|-1.2||||0.4611|TWO_SIDED|95.0|-4.41|2.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.00|-4.41|0.4611
91721816|NCT05258721|183335813|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91721817|NCT05258721|183335814|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p =0.05|Kruskal-Wallis|||||||<0.001
91721818|NCT05258721|183335815|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91721819|NCT02612155|183335840|OTHER|||||||0.06|||||||Fisher Exact|||||||0.06
91690554|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|8.659|||<|0.0001|TWO_SIDED|95.0|4.496|12.822|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||12.822|4.496|<0.0001
91690555|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|4.361||||0.0702|TWO_SIDED|95.0|-0.362|9.084|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||9.084|-0.362|0.0702
91690556|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|10.085|||<|0.0001|TWO_SIDED|95.0|5.349|14.821|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.821|5.349|<0.0001
91690557|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|6.045||||0.03|TWO_SIDED|95.0|0.589|11.501|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.501|0.589|0.0300
91690558|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|9.803||||0.0005|TWO_SIDED|95.0|4.368|15.237|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.237|4.368|0.0005
91690559|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|7.569||||0.0067|TWO_SIDED|95.0|2.119|13.019|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||13.019|2.119|0.0067
91690560|NCT03349060|183274492|SUPERIORITY||Difference in LS mean|9.374||||0.0008|TWO_SIDED|95.0|3.933|14.815|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.815|3.933|0.0008
91690561|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|-0.004||||0.9568|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.130|-0.137|0.9568
91690562|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.09||||0.1782|TWO_SIDED|95.0|-0.042|0.223|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.223|-0.042|0.1782
91690563|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.174||||0.0491|TWO_SIDED|95.0|0.001|0.347|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.347|0.001|0.0491
91721820|NCT04235374|183335847|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
91721821|NCT04235374|183335848|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
91721822|NCT04235374|183335849|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
91721823|NCT04235374|183335850|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
91721824|NCT04235374|183335851|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
91721825|NCT01394276|183335855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237|||||||Exact binomial proportion test|||||||0.0237
91721826|NCT01394276|183335856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Exact binomial proportion test|||||||0.0003
91721827|NCT01394276|183335868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.808|TWO_SIDED|95.0|-0.3|0.4|||t-test, 2 sided|||At Baseline: mean difference of scores of DAS28 between the two groups was calculated.||0.4|-0.3|0.8080
91721828|NCT01394276|183335868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4884|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||At Month 1: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.5|0.4884
91721829|NCT01394276|183335868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.0947|TWO_SIDED|95.0|-0.7|0.1|||t-test, 2 sided|||At Month 2: mean difference of scores of DAS28 between the two groups was calculated.||0.1|-0.7|0.0947
91721830|NCT01394276|183335868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.8181|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 4: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.8181
91721831|NCT01394276|183335868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9721|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 6: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.9721
91721832|NCT01394276|183335868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.5832|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||At Month 12: mean difference of scores of DAS28 between the two groups was calculated.||0.5|-0.3|0.5832
91721833|NCT01394276|183335869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.5||||0.4211|TWO_SIDED|95.0|-5.1|12.2|||t-test, 2 sided|||At Baseline: mean difference of scores of fatigue between the two groups was calculated.||12.2|-5.1|0.4211
91690564|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.284||||0.0015|TWO_SIDED|95.0|0.112|0.456|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.456|0.112|0.0015
91690565|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.004||||0.9638|TWO_SIDED|95.0|-0.185|0.194|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.194|-0.185|0.9638
91690566|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.08||||0.4016|TWO_SIDED|95.0|-0.109|0.27|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.270|-0.109|0.4016
91690567|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.007||||0.9429|TWO_SIDED|95.0|-0.184|0.198|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.198|-0.184|0.9429
91690568|NCT03349060|183274493|SUPERIORITY||Difference in LS mean|0.062||||0.5212|TWO_SIDED|95.0|-0.13|0.254|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.254|-0.130|0.5212
91690569|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|2.131||||0.6467|TWO_SIDED|95.0|-7.095|11.358|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.358|-7.095|0.6467
91690570|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|11.549||||0.0147|TWO_SIDED|95.0|2.338|20.761|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.761|2.338|0.0147
91690571|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|6.853||||0.1894|TWO_SIDED|95.0|-3.453|17.159|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||17.159|-3.453|0.1894
91690572|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|16.99||||0.0015|TWO_SIDED|95.0|6.699|27.281|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||27.281|6.699|0.0015
91690573|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|8.672||||0.1267|TWO_SIDED|95.0|-2.518|19.862|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||19.862|-2.518|0.1267
91690574|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|9.354||||0.1009|TWO_SIDED|95.0|-1.866|20.573|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.573|-1.866|0.1009
91690575|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|6.071||||0.1915|TWO_SIDED|95.0|-3.107|15.249|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.249|-3.107|0.1915
91690576|NCT03349060|183274494|SUPERIORITY||Difference in LS mean|12.948||||0.0064|TWO_SIDED|95.0|3.754|22.143|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||22.143|3.754|0.0064
91690577|NCT03349060|183274495|SUPERIORITY||Difference in LS mean|3.6||||0.0102|TWO_SIDED|95.0|0.9|6.4||Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.4|0.9|0.0102
91690578|NCT03349060|183274495|SUPERIORITY||Difference in LS mean|4.5||||0.0013|TWO_SIDED|95.0|1.8|7.3||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.3|1.8|0.0013
91690579|NCT03349060|183274496|SUPERIORITY||Difference in LS mean|1.0||||0.5241|TWO_SIDED|95.0|-2.1|4.2||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.2|-2.1|0.5241
91690580|NCT03349060|183274496|SUPERIORITY||Difference in LS mean|0.9||||0.5821|TWO_SIDED|95.0|-2.3|4.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.1|-2.3|0.5821
91690581|NCT03349060|183274497|SUPERIORITY||Difference in LS mean|3.8||||0.0013|TWO_SIDED|95.0|1.5|6.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.1|1.5|0.0013
91690582|NCT03349060|183274497|SUPERIORITY||Difference in LS mean|4.7|||<|0.0001|TWO_SIDED|95.0|2.4|7.0||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.0|2.4|<0.0001
91690583|NCT03349060|183274498|SUPERIORITY||Difference in LS mean|1.7||||0.2256|TWO_SIDED|95.0|-1.0|4.4||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.4|-1.0|0.2256
91721834|NCT01394276|183335869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.1||||0.6749|TWO_SIDED|95.0|-7.9|12.1|||t-test, 2 sided|||At Month 1: mean difference of scores of fatigue between the two groups was calculated.||12.1|-7.9|0.6749
91488934|NCT02713204|182850252|SUPERIORITY|Threshold for significance at 0.05 level.|Least square mean difference|-2.0||||0.2225|TWO_SIDED|95.0|-5.22|1.22|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.22|-5.22|0.2225
91488935|NCT02713204|182850252|SUPERIORITY||Least square mean difference|-0.82||||0.6063|TWO_SIDED|95.0|-3.97|2.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.32|-3.97|0.6063
91527697|NCT01976364|182930496|OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-0.4|
91690584|NCT03349060|183274498|SUPERIORITY||Difference in LS mean|3.0||||0.0275|TWO_SIDED|95.0|0.3|5.8||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||5.8|0.3|0.0275
91690585|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|3.9|||<|0.0001|TWO_SIDED|95.0|2.0|7.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||7.7|2.0|<0.0001
91690586|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.1|0.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.6|0.1|<0.0001
91690587|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|1.5||||0.6334|TWO_SIDED|95.0|0.8|3.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.0|0.8|0.6334
91690588|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.6||||0.8065|TWO_SIDED|95.0|0.2|1.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.6|0.2|0.8065
91690589|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|10.0|||<|0.0001|TWO_SIDED|95.0|3.8|26.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||26.6|3.8|<0.0001
91690590|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
91690591|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
91690592|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
91690593|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.4||||0.0011|TWO_SIDED|95.0|0.2|0.8||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.8|0.2|0.0011
91690594|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
91690595|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|2.6||||0.0718|TWO_SIDED|95.0|1.0|6.9||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||6.9|1.0|0.0718
91690596|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
91690597|NCT02861586|183274500|SUPERIORITY||Gemetric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
91690598|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|5.2|||<|0.0001|TWO_SIDED|95.0|2.6|10.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||10.4|2.6|<0.0001
91690599|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|2.2||||0.2005|TWO_SIDED|95.0|0.8|5.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||5.7|0.8|0.2005
91690600|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|35.0|||<|0.0001|TWO_SIDED|95.0|13.1|93.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||93.1|13.1|<0.0001
91690601|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
91690602|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|0.0|0.0|0.1|||ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
91721835|NCT01394276|183335869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.4||||0.1817|TWO_SIDED|95.0|-3.0|15.9|||t-test, 2 sided|||At Month 2: mean difference of scores of fatigue between the two groups was calculated.||15.9|-3.0|0.1817
91721836|NCT01394276|183335869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.8||||0.5182|TWO_SIDED|95.0|-5.8|11.4|||t-test, 2 sided|||At Month 4: mean difference of scores of fatigue between the two groups was calculated.||11.4|-5.8|0.5182
91488936|NCT02713204|182850252|SUPERIORITY||Least square mean difference|-3.25||||0.0426|TWO_SIDED|95.0|-6.39|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.11|-6.39|0.0426
91488937|NCT02713204|182850252|SUPERIORITY||Least square mean difference|-4.39||||0.0073|TWO_SIDED|95.0|-7.58|-1.19||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-1.19|-7.58|0.0073
91488938|NCT02713204|182850252|SUPERIORITY||Least square mean difference|1.17||||0.469|TWO_SIDED|95.0|-2.01|4.36||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.36|-2.01|0.4690
91527182|NCT04424290|182929703|OTHER||Adjusted mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-2.7|7.9|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||7.9|-2.7|
91690603|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.4||||0.1138|TWO_SIDED|95.0|0.2|1.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.1|0.2|0.1138
91488939|NCT02713204|182850252|SUPERIORITY||Least square mean difference|2.42||||0.1267|TWO_SIDED|95.0|-0.69|5.54||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.54|-0.69|0.1267
91690604|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|6.7|||<|0.0001|TWO_SIDED|95.0|2.5|18.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||18.1|2.5|<0.0001
91690605|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
91690606|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
91690607|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|16.0|||<|0.0001|TWO_SIDED|95.0|4.9|52.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||52.4|4.9|<0.0001
91690608|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
91690609|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
91690610|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
91690611|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
91690612|NCT02861586|183274500|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.2|0.3|1.0000
91690613|NCT02861586|183274509|SUPERIORITY||Geometric mean ratio|0.9||||0.9775|TWO_SIDED|95.0|0.4|2.0|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.0|0.4|0.9775
91690614|NCT02861586|183274509|SUPERIORITY||Geometric mean ratio|1.3||||0.8366|TWO_SIDED|95.0|0.6|3.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.1|0.6|0.8366
91690615|NCT02861586|183274509|SUPERIORITY||Geometric mean ratio|1.5||||0.5625|TWO_SIDED|95.0|0.7|3.6|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.6|0.7|0.5625
91488940|NCT02713204|182850253|SUPERIORITY||Least square mean difference|-11.57||||0.413|TWO_SIDED|95.0|-39.5|16.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.20|-39.5|0.4130
91488941|NCT02713204|182850253|SUPERIORITY||Least square mean difference|-4.88||||0.6587|TWO_SIDED|95.0|-26.2|16.85|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.85|-26.2|0.6587
91488942|NCT02713204|182850254|SUPERIORITY||Least square mean difference|17.04||||0.3833|TWO_SIDED|95.0|-21.35|55.43||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||55.43|-21.35|0.3833
91721837|NCT01394276|183335869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.7||||0.0025|TWO_SIDED|95.0|4.9|22.6|||t-test, 2 sided|||At Month 6: mean difference of scores of fatigue between the two groups was calculated.||22.6|4.9|0.0025
91488943|NCT02713204|182850254|SUPERIORITY||Least square mean difference|12.85||||0.5141|TWO_SIDED|95.0|-25.84|51.53||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||51.53|-25.84|0.5141
91488944|NCT02713204|182850254|SUPERIORITY||Least square mean difference|33.89||||0.0785|TWO_SIDED|95.0|-3.89|71.67|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||71.67|-3.89|0.0785
91488945|NCT02713204|182850254|SUPERIORITY||Least square mean difference|42.27||||0.0281|TWO_SIDED|95.0|4.56|79.98||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||79.98|4.56|0.0281
91488946|NCT02713204|182850254|SUPERIORITY||Least square mean difference|16.65||||0.3934|TWO_SIDED|95.0|-21.67|54.96||Threshold for significance at 0.05 level.|ANCOVA|||||54.96|-21.67|0.3934
91488947|NCT02713204|182850254|SUPERIORITY||Least square mean difference|21.05||||0.279|TWO_SIDED|95.0|-17.13|59.22||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||59.22|-17.13|0.2790
91721838|NCT01394276|183335869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9||||0.354|TWO_SIDED|95.0|-4.4|12.1|||t-test, 2 sided|||At Month 12: mean difference of scores of fatigue between the two groups was calculated.||12.1|-4.4|0.3540
91721839|NCT01394276|183335870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.7343|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Baseline: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.7343
91488948|NCT02713204|182850254|SUPERIORITY||Least square mean difference|-8.38||||0.6586|TWO_SIDED|95.0|-45.64|28.88||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||28.88|-45.64|0.6586
91488949|NCT02713204|182850255|SUPERIORITY||Least square mean difference|0.55||||0.4889|TWO_SIDED|95.0|-1.01|2.1||Threshold for significance at 0.05 level.|ANCOVA|||||2.10|-1.01|0.4889
91488950|NCT02713204|182850255|SUPERIORITY||Least square mean difference|0.24||||0.7027|TWO_SIDED|95.0|-0.99|1.46||Threshold for significance at 0.05 level.|ANCOVA|||||1.46|-0.99|0.7027
91721840|NCT01394276|183335870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.1098|TWO_SIDED|95.0|-0.4|0.0|||t-test, 2 sided|||At Month 1: mean difference of scores of HAQ between the two groups was calculated.||0.0|-0.4|0.1098
91721841|NCT01394276|183335870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4932|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||At Month 2: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.3|0.4932
91721842|NCT01394276|183335870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.2468|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||At Month 4: mean difference of scores of HAQ between the two groups was calculated.||0.1|-0.4|0.2468
91721843|NCT01394276|183335870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9639|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Month 6: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.9639
91721844|NCT01394276|183335870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.6696|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||At Month 12: mean difference of scores of HAQ between the two groups was calculated.||0.3|-0.2|0.6696
91488951|NCT02713204|182850256|SUPERIORITY||Least square mean difference|-0.6||||0.4927|TWO_SIDED|95.0|-2.34|1.13||Threshold for significance at 0.05 level.|ANCOVA|||||1.13|-2.34|0.4927
91488952|NCT02713204|182850256|SUPERIORITY||Least square mean difference|0.38||||0.6645|TWO_SIDED|95.0|-1.36|2.13||Threshold for significance at 0.05 level.|ANCOVA|||||2.13|-1.36|0.6645
91488953|NCT02713204|182850256|SUPERIORITY||Least square mean difference|-0.89||||0.3091|TWO_SIDED|95.0|-2.61|0.83||Threshold for significance at 0.05 level.|ANCOVA|||||0.83|-2.61|0.3091
91488954|NCT02713204|182850256|SUPERIORITY||Least square mean difference|-0.6||||0.4898|TWO_SIDED|95.0|-2.29|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-2.29|0.4898
91488955|NCT02713204|182850256|SUPERIORITY||Least square mean difference|-0.8||||0.3504|TWO_SIDED|95.0|-2.5|0.89||Threshold for significance at 0.05 level.|ANCOVA|||||0.89|-2.50|0.3504
91488956|NCT02713204|182850256|SUPERIORITY||Least square mean difference|-0.98||||0.2632|TWO_SIDED|95.0|-2.7|0.74||Threshold for significance at 0.05 level.|ANCOVA|||||0.74|-2.70|0.2632
91488957|NCT02713204|182850256|SUPERIORITY||Least square mean difference|0.21||||0.8056|TWO_SIDED|95.0|-1.46|1.88||Threshold for significance at 0.05 level.|ANCOVA|||||1.88|-1.46|0.8056
91488958|NCT02713204|182850257|SUPERIORITY||Least square mean difference|0.57||||0.5065|TWO_SIDED|95.0|-1.11|2.25||Threshold for significance at 0.05 level.|ANCOVA|||||2.25|-1.11|0.5065
91488959|NCT02713204|182850257|SUPERIORITY||Least square mean difference|-0.22||||0.7418|TWO_SIDED|95.0|-1.55|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-1.55|0.7418
91488960|NCT02713204|182850258|SUPERIORITY||Least square mean difference|-0.19||||0.8383|TWO_SIDED|95.0|-1.99|1.62||Threshold for significance at 0.05 level.|ANCOVA|||||1.62|-1.99|0.8383
91488961|NCT02713204|182850258|SUPERIORITY||Least square mean difference|-0.1||||0.918|TWO_SIDED|95.0|-1.91|1.72||Threshold for significance at 0.05 level.|ANCOVA|||||1.72|-1.91|0.9180
91488962|NCT02713204|182850258|SUPERIORITY||Least square mean difference|-1.41||||0.1238|TWO_SIDED|95.0|-3.2|0.39||Threshold for significance at 0.05 level.|ANCOVA|||||0.39|-3.20|0.1238
91488963|NCT02713204|182850258|SUPERIORITY||Least square mean difference|-0.97||||0.2819|TWO_SIDED|95.0|-2.73|0.8||Threshold for significance at 0.05 level.|ANCOVA|||||0.80|-2.73|0.2819
91488964|NCT02713204|182850258|SUPERIORITY||Least square mean difference|-1.02||||0.2581|TWO_SIDED|95.0|-2.78|0.75||Threshold for significance at 0.05 level.|ANCOVA|||||0.75|-2.78|0.2581
91488965|NCT02713204|182850258|SUPERIORITY||Least square mean difference|-0.87||||0.339|TWO_SIDED|95.0|-2.66|0.92||Threshold for significance at 0.05 level.|ANCOVA|||||0.92|-2.66|0.3390
91488966|NCT02713204|182850258|SUPERIORITY||Least square mean difference|0.05||||0.9558|TWO_SIDED|95.0|-1.69|1.79||Threshold for significance at 0.05 level.|ANCOVA|||||1.79|-1.69|0.9558
91488967|NCT02635776|182850300|SUPERIORITY||Risk Difference (RD)|63.2|||<|0.0001|TWO_SIDED|95.0|53.0|73.3|||Farrington-Manning test|||Treatment difference at 600 mg||73.3|53|<0.0001
91488968|NCT02635776|182850301|SUPERIORITY||Risk Difference (RD)|47.8|||<|0.0001|TWO_SIDED|95.0|38.0|57.7|||Farrington-Manning test|||Treatment difference at 1000 mg||57.7|38|<0.0001
91488969|NCT02635776|182850302|SUPERIORITY||Risk Difference (RD)|68.5|||<|0.0001|TWO_SIDED|95.0|58.6|78.5|||Farrington-Manning test|||Treatment difference at 300 mg||78.5|58.6|<0.0001
91488970|NCT02635776|182850303|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (using equally spaced scores), stratified by region (North America, Europe)||Treatment difference in maximum severity||||<0.0001
91488971|NCT00660673|182850316|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in off time was assessed for significance using a 1-sample paired t test"||||<0.001
91488972|NCT00660673|182850316|OTHER|||||||0.433|||||||One-sample t-test|||"Change from Baseline to end of study in off time was assessed for significance using a 1-sample paired t-test."||||0.433
91488973|NCT00660673|182850317|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t-test."||||<0.001
91488974|NCT00660673|182850317|OTHER|||||||0.15|||||||One-sample t-test|||"Change from Baseline to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.150
91488975|NCT00660673|182850318|OTHER|||||||0.725|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.725
91488976|NCT00660673|182850318|OTHER|||||||0.019|||||||One-sample t-test|||"Change from Baseline to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.019
91690616|NCT02861586|183274509|SUPERIORITY||Geometric mean ratio|1.5||||0.5924|TWO_SIDED|95.0|0.6|3.5|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.5|0.6|0.5924
91690617|NCT02861586|183274509|SUPERIORITY||Geometric mean ratio|1.8||||0.3122|TWO_SIDED|95.0|0.8|4.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||4.1|0.8|0.3122
91488977|NCT00579098|182850326|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.75
91488978|NCT00579098|182850327|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.37
91488979|NCT00579098|182850328|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.11
91488980|NCT00579098|182850329|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||Comparison between treatment groups. A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.53
91488981|NCT00579098|182850330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in total cholesterol was compared between treatment groups.||||<0.001
91488982|NCT00579098|182850330|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in LDL cholesterol was compared between treatment groups.||||<0.001
91488983|NCT00579098|182850330|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in HDL cholesterol was compared between treatment groups.||||0.92
91488984|NCT01903031|182850362|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
91488985|NCT01903031|182850362|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||<0.001
91488986|NCT01903031|182850363|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
91488987|NCT01903031|182850363|OTHER|||||||0.004||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||0.004
91488988|NCT02298023|182850505|OTHER|||||||0.35|||||||Kruskal-Wallis|||Null hypothesis: There is no difference between the three groups. Statistical power: 0.80||||0.35
91488989|NCT02298023|182850506|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.662|||||||Mixed Models Analysis|||||||0.662
91488990|NCT02298023|182850507|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.882|||||||Mixed Models Analysis|||||||0.882
91488991|NCT02298023|182850508|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.835|||||||Mixed Models Analysis|||||||0.835
91488992|NCT02298023|182850509|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.977|||||||Mixed Models Analysis|||||||0.977
91488993|NCT02298023|182850510|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.867|||||||Mixed Models Analysis|||||||0.867
91527183|NCT04424290|182929704|OTHER||Adjusted mean difference|7.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-1.2|16.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.5|-1.2|
91721845|NCT04530344|183335871|SUPERIORITY||Hazard Ratio (HR)|0.422||||0.0414|TWO_SIDED|95.0|0.18|0.99|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.990|0.180|0.0414
91721846|NCT04530344|183335872|SUPERIORITY||Hazard Ratio (HR)|0.316||||0.0003|TWO_SIDED|95.0|0.165|0.606|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.606|0.165|0.0003
91721847|NCT01933594|183335899|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91721848|NCT01933594|183335900|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.94
91721849|NCT01933594|183335900|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.74
91721850|NCT01933594|183335900|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.18
91488994|NCT02298023|182850511|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.916|||||||Chi-squared|||||||0.916
91488995|NCT02298023|182850512|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.892|||||||Chi-squared|||||||0.892
91721851|NCT01933594|183335900|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.16
91721852|NCT01933594|183335901|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91488996|NCT04010695|182850519|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
91488997|NCT02002832|182850520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.|Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||||6.3|1.0|
91488998|NCT03329508|182850522|SUPERIORITY||Differences of Least Square Means|-2.66|STANDARD_ERROR_OF_MEAN|0.85||0.0018|TWO_SIDED|95.0|-4.33|-1.0|||MMRM|||||-1.0|-4.33|0.0018
91488999|NCT03329508|182850522|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.85||0.0001|TWO_SIDED|95.0|-4.96|-1.63|||MMRM|||||-1.63|-4.96|0.0001
91721853|NCT01933594|183335902|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.9
91721854|NCT01933594|183335902|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.07
91721855|NCT01933594|183335902|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
91721856|NCT01933594|183335902|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.92
91721857|NCT01933594|183335903|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 6 hours post infusion||||0.44
91721858|NCT01933594|183335903|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 12 hours post infusion||||0.024
91721859|NCT01933594|183335903|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.37
91721860|NCT01933594|183335903|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.79
91721861|NCT01933594|183335903|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.34
91721862|NCT01933594|183335904|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
91721863|NCT01933594|183335905|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91721864|NCT01933594|183335906|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91721865|NCT01933594|183335908|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.19
91721866|NCT01933594|183335908|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.63
91721867|NCT01933594|183335908|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.94
91721868|NCT01933594|183335908|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.66
91721869|NCT01933594|183335908|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
91721870|NCT01933594|183335909|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion||||0.73
91721871|NCT01933594|183335909|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.9
91721872|NCT01933594|183335910|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.8
91721873|NCT01933594|183335910|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.73
91721874|NCT01933594|183335910|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.84
91527698|NCT01976364|182930496|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-1.0|
91690618|NCT02861586|183274509|SUPERIORITY||Geometric mean ratio|1.2||||0.9665|TWO_SIDED|95.0|0.5|2.8|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.8|0.5|0.9665
91690619|NCT04796909|183274528|SUPERIORITY|||||||0.05|||||||Repeated-measures ANCOVA|||||||0.05
91690620|NCT04796909|183274529|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
91690621|NCT04796909|183274530|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
91690622|NCT04796909|183274531|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
91690623|NCT04796909|183274532|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
91690624|NCT04796909|183274533|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
91690625|NCT04796909|183274534|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
91690626|NCT04796909|183274535|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91690627|NCT04796909|183274536|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91690628|NCT04796909|183274537|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91690629|NCT00437021|183274543|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.97|1.99|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||1.99|0.97|
91690630|NCT00437021|183274544|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.895|||||TWO_SIDED|95.0|2.22|3.69|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.69|2.22|
91690631|NCT00437021|183274552|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|1.65|2.76|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||2.76|1.65|
91690632|NCT00437021|183274553|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|3.08|||||TWO_SIDED|95.0|2.57|3.59|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.59|2.57|
91690633|NCT04162847|183274554|SUPERIORITY||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.88|1.1|||Regression, Logistic|||Baseline||1.10|.88|.76
91690634|NCT04162847|183274554|SUPERIORITY||Odds Ratio (OR)|0.84||||0.001|TWO_SIDED|95.0|0.76|0.93|||Regression, Logistic|||6 week follow-up||.93|.76|.001
91690635|NCT04162847|183274554|SUPERIORITY||Odds Ratio (OR)|0.82||||0|TWO_SIDED|95.0|0.74|0.9|||Regression, Logistic|||6 month follow-up||.90|.74|.000
91690636|NCT04162847|183274554|SUPERIORITY||Odds Ratio (OR)|0.86||||0.002|TWO_SIDED|95.0|0.77|0.95|||Regression, Logistic|||2 year||.95|.77|.002
91690637|NCT04162847|183274555|SUPERIORITY||Odds Ratio (OR)|6.7||||0|TWO_SIDED|95.0|5.98|7.5|||Chi-squared|||A comparison of service uptake between the intervention and control groups over the 6-month follow-up period.||7.50|5.98|.000
91690638|NCT04162847|183274555|SUPERIORITY||Odds Ratio (OR)|1.83||||0|TWO_SIDED|95.0|1.64|2.04|||Chi-squared|||A secondary analysis using the same criterion for the intervention group (access to the digital intervention during the 6-month follow-up) but expanding the control group definition to include individuals who reported having psychotherapy or starting a new medication at any point during the full 2-year follow-up period.||2.04|1.64|.000
91690639|NCT04162847|183274556|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 week||||.000
91690640|NCT04162847|183274556|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 months||||.000
91690641|NCT04162847|183274556|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 2 year||||.02
91690642|NCT04162847|183274556|SUPERIORITY|||||||0.002|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 week||||.002
91690643|NCT04162847|183274556|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 month||||.80
91690644|NCT04162847|183274556|SUPERIORITY|||||||0.51|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 2 year||||.51
91690645|NCT04162847|183274556|SUPERIORITY|||||||0.004|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 week||||.004
91690646|NCT04162847|183274556|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 month||||.02
91690647|NCT04162847|183274556|SUPERIORITY|||||||0.09|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 2 year||||.09
91690648|NCT04162847|183274556|SUPERIORITY|||||||0.66|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 week||||.66
91721875|NCT01933594|183335910|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
91489000|NCT03329508|182850523|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.0001
91489001|NCT03329508|182850523|SUPERIORITY||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.05|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.05
91489002|NCT03329508|182850524|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.67||0.0231|TWO_SIDED|95.0|-2.84|-0.21|||MMRM|||||-0.21|-2.84|0.0231
91489003|NCT03329508|182850524|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.67||0.0092|TWO_SIDED|95.0|-3.06|-0.43|||MMRM|||||-0.43|-3.06|0.0092
91489004|NCT03329508|182850525|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.31||0.0001|TWO_SIDED|95.0|-1.77|-0.57|||MMRM|||||-0.57|-1.77|0.0001
91489005|NCT03329508|182850525|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92|||MMRM|||||-0.92|-2.13|<0.0001
91489006|NCT03329508|182850526|SUPERIORITY||Mean Difference (Net)|-2.18|STANDARD_ERROR_OF_MEAN|1.54||0.1589|TWO_SIDED|95.0|-5.21|0.85|||MMRM|||||0.85|-5.21|0.1589
91489007|NCT00492531|182850530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.7|TWO_SIDED|95.0|-56.0|38.0|||ANCOVA|6 minute walk was based on ANCOVA model with treatment as a fixed effect and 6 minute walk distance, TRV stratum and study site as covariate.||||38|-56|0.70
91489008|NCT03572972|182850538|SUPERIORITY||Hazard Ratio (HR)|0.618|||||TWO_SIDED|95.0|0.541|0.707||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of hazard ratio (HR) at year 1 as an extended Cox model was used.||0.707|0.541|
91489009|NCT03572972|182850538|SUPERIORITY||Hazard Ratio (HR)|0.604|||||TWO_SIDED|95.0|0.53|0.687||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.687|0.530|
91489010|NCT03572972|182850538|SUPERIORITY||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.563|0.884|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.884|0.563|
91489011|NCT03572972|182850539|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.87|1.134||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.134|0.870|
91489012|NCT03572972|182850539|SUPERIORITY||Hazard Ratio (HR)|0.949|||||TWO_SIDED|95.0|0.839|1.073||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.073|0.839|
91489013|NCT03572972|182850539|SUPERIORITY||Hazard Ratio (HR)|0.961|||||TWO_SIDED|95.0|0.854|1.082||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.082|0.854|
91489014|NCT03572972|182850540|SUPERIORITY||Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.512|0.664||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.664|0.512|
91489015|NCT03572972|182850540|SUPERIORITY||Hazard Ratio (HR)|0.754|||||TWO_SIDED|95.0|0.597|0.953|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.953|0.597|
91690649|NCT04162847|183274556|SUPERIORITY|||||||0.85|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 month||||.85
91690650|NCT04162847|183274556|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 2 year||||.97
91690651|NCT04162847|183274556|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 week||||.000
91690652|NCT04162847|183274556|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 month||||.000
91489016|NCT03572972|182850540|SUPERIORITY||Hazard Ratio (HR)|0.844|||||TWO_SIDED|95.0|0.685|1.04|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.040|0.685|
91489017|NCT03572972|182850541|SUPERIORITY||Hazard Ratio (HR)|0.866|||||TWO_SIDED|95.0|0.761|0.985||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.985|0.761|
91489018|NCT03572972|182850541|SUPERIORITY||Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.684|0.862||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.862|0.684|
91489019|NCT03572972|182850541|SUPERIORITY||Hazard Ratio (HR)|0.875|||||TWO_SIDED|95.0|0.786|0.975||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.975|0.786|
91527184|NCT04424290|182929705|OTHER||Adjusted mean difference|13.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-2.3|29.8|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||29.8|-2.3|
91690653|NCT04162847|183274556|SUPERIORITY|||||||0.54|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 2 year||||.54
91690654|NCT04162847|183274557|SUPERIORITY|||||||0.48|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 6 months||||.48
91690655|NCT04162847|183274557|SUPERIORITY|||||||0.04|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 2 years||||.04
91489020|NCT03572972|182850542|SUPERIORITY||Hazard Ratio (HR)|0.673|||||TWO_SIDED|95.0|0.47|0.964||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.964|0.470|
91489021|NCT03572972|182850542|SUPERIORITY||Hazard Ratio (HR)|0.491|||||TWO_SIDED|95.0|0.337|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.337|
91489022|NCT03572972|182850542|SUPERIORITY||Hazard Ratio (HR)|0.747|||||TWO_SIDED|95.0|0.548|1.018||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.018|0.548|
91527699|NCT01976364|182930496|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-1.6|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-1.6|
91690656|NCT04162847|183274557|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 6 months||||.97
91690657|NCT04162847|183274557|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 2 years||||.80
91690658|NCT03985800|183274564|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.26||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.26 with two degrees of freedom.||Null hypothesis: The trajectory of IBD complexity score does not differ by treatment group.||||0.53
91489023|NCT03572972|182850543|SUPERIORITY||Hazard Ratio (HR)|1.463|||||TWO_SIDED|95.0|0.998|2.145||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||2.145|0.998|
91489024|NCT03572972|182850543|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.647|1.225||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.225|0.647|
91690659|NCT03985800|183274564|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.14||||0.57||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.14 with two degrees of freedom.||Aim 2b., moderation by age. Null hypothesis: Age does not moderate the trajectory of complexity score by treatment group.||||0.57
91489025|NCT03572972|182850543|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.447|0.888||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.888|0.447|
91489026|NCT03572972|182850544|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.556|0.738||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.738|0.556|
91489027|NCT03572972|182850544|SUPERIORITY||Hazard Ratio (HR)|0.624|||||TWO_SIDED|95.0|0.544|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.544|
91489028|NCT03572972|182850544|SUPERIORITY||Hazard Ratio (HR)|0.749|||||TWO_SIDED|95.0|0.588|0.954|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.954|0.588|
91489029|NCT03572972|182850545|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.85|1.122||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.122|0.850|
91489030|NCT03572972|182850545|SUPERIORITY||Hazard Ratio (HR)|0.966|||||TWO_SIDED|95.0|0.848|1.1||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.100|0.848|
91489031|NCT03572972|182850545|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.877|1.125||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.125|0.877|
91489032|NCT03572972|182850546|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.119|0.523||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.523|0.119|
91527700|NCT01976364|182930496|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
91721876|NCT01933594|183335910|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.64
91721877|NCT01933594|183335918|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.34
91721878|NCT01933594|183335918|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
91721879|NCT01933594|183335918|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
91690660|NCT03985800|183274564|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.08||||0.96||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 0.08 with two degrees of freedom.||Aim 2b., moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of complexity score by treatment group.||||0.96
91489033|NCT03572972|182850546|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.203|0.711||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.711|0.203|
91489034|NCT03572972|182850546|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.247|0.722||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.722|0.247|
91489035|NCT03572972|182850547|SUPERIORITY||Hazard Ratio (HR)|0.745|||||TWO_SIDED|95.0|0.343|1.615||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.615|0.343|
91489036|NCT03572972|182850547|SUPERIORITY||Hazard Ratio (HR)|0.692|||||TWO_SIDED|95.0|0.342|1.402||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.402|0.342|
91489037|NCT03572972|182850547|SUPERIORITY||Hazard Ratio (HR)|0.932|||||TWO_SIDED|95.0|0.498|1.747||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.747|0.498|
91489038|NCT03572972|182850548|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.492|0.731||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.731|0.492|
91690661|NCT03985800|183274564|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|6.41||||0.17||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 6.41 with two degrees of freedom.||Aim 2b., moderation by site. Null hypothesis: Site does not moderate the trajectory of complexity score by treatment group.||||0.17
91690662|NCT03985800|183274564|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|2.6||||0.27||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 2.6 with two degrees of freedom.||Aim 2b., moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of complexity score by treatment group.||||0.27
91489039|NCT03572972|182850548|SUPERIORITY||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.719|1.522|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.522|0.719|
91489040|NCT03572972|182850548|SUPERIORITY||Hazard Ratio (HR)|1.295|||||TWO_SIDED|95.0|0.92|1.824|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.824|0.920|
91527701|NCT01976364|182930496|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
91489041|NCT03572972|182850549|SUPERIORITY||Hazard Ratio (HR)|0.751|||||TWO_SIDED|95.0|0.62|0.91||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.91|0.62|
91489042|NCT03572972|182850549|SUPERIORITY||Hazard Ratio (HR)|0.697|||||TWO_SIDED|95.0|0.586|0.83||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.830|0.586|
91489043|NCT03572972|182850549|SUPERIORITY||Hazard Ratio (HR)|0.936|||||TWO_SIDED|95.0|0.801|1.094||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.094|0.801|
91489044|NCT03572972|182850550|SUPERIORITY||Hazard Ratio (HR)|0.373|||||TWO_SIDED|95.0|0.212|0.658|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.658|0.212|
91489045|NCT03572972|182850550|SUPERIORITY||Hazard Ratio (HR)|0.538|||||TWO_SIDED|95.0|0.392|0.737||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.737|0.392|
91690663|NCT03985800|183274565|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.21||||0.9||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 0.21 with two degrees of freedom.||Aim 1. The trajectory of PHQ-ADS does not differ by treatment group.||||0.90
91690664|NCT03985800|183274565|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.21||||0.55||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|||Aim 2a, moderation by disease activity. Null hypothesis: Disease activity does not moderate the trajectory of behavioral health score by treatment group.||||0.55
91721880|NCT01933594|183335918|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.008
91721881|NCT01933594|183335918|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 2 weeks post infusion 4||||0.55
91721882|NCT01933594|183335918|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 5 weeks post infusion 4||||0.48
91721883|NCT01933594|183335918|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.54
91721884|NCT01933594|183335918|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 18 weeks post infusion 4||||0.47
91721885|NCT01933594|183335920|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.95
91721886|NCT01933594|183335920|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.07
91721887|NCT01933594|183335920|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.26
91721888|NCT01933594|183335921|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.89
91721889|NCT01933594|183335921|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.14
91721890|NCT01933594|183335921|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.74
91721891|NCT01933594|183335922|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.71
91721892|NCT01933594|183335922|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.79
91721893|NCT01933594|183335922|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.38
91721894|NCT01933594|183335923|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||1
91721895|NCT01933594|183335923|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.92
91721896|NCT01933594|183335923|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.66
91721897|NCT01933594|183335924|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||1
91721898|NCT01933594|183335924|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.9
91721899|NCT01933594|183335924|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.47
91721900|NCT01933594|183335925|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.63
91690665|NCT03985800|183274565|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.37||||0.5||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.37 with two degrees of freedom.||Aim 2b, moderation by age. Null hypothesis: Age does not moderate the trajectory of behavioral health score by treatment group.||||0.50
91690666|NCT03985800|183274565|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|5.16||||0.08||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 5.16 with two degrees of freedom.||Aim 2b, moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of behavioral health score by treatment group.||||0.08
91690667|NCT03985800|183274565|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.11||||1||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 0.11 with two degrees of freedom.||Aim 2b, moderation by site. Null hypothesis: Site does not moderate the trajectory of behavioral health score by treatment group.||||1.0
91690668|NCT03985800|183274565|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.23||||0.2||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*eHealth literacy interaction term is 3.23 with two degrees of freedom.||Aim 2b, moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of behavioral health score by treatment group.||||0.20
91690669|NCT03985800|183274566|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.09||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 3.09 with two degrees of freedom.||Null hypothesis: The trajectory of functional impairment does not differ by treatment group.||||0.53
91690670|NCT03985800|183274567|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|6.01||||0.05||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 6.01 with two degrees of freedom.||Null hypothesis: The trajectory of IBD-IBS symptom severity does not differ by treatment group.||||0.05
91690671|NCT03985800|183274568|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|4.14||||0.13||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For hospitalizations, the Chi-squared statistic for the group\*time interaction term is 4.14 with two degrees of freedom||Null hypothesis: The trajectory of hospitalizations does not differ by treatment group.||||0.13
91690672|NCT03985800|183274568|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.82||||0.67||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For ED visits, the Chi-squared statistic for the group\*time interaction term is 0.82 with two degrees of freedom.||Null hypothesis: The trajectory of ED visits does not differ by treatment group.||||0.67
91690673|NCT03985800|183274569|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.98||||0.37||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.98 with two degrees of freedom.||Null hypothesis: The trajectory of self-efficacy does not differ by treatment group.||||0.37
91690674|NCT03985800|183274570|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|5.57||||0.06||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 5.57 with two degrees of freedom.||Null hypothesis: The trajectory of quality of life does not differ by treatment group.||||0.06
91721901|NCT01933594|183335925|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||hange from baseline to 24 hours post infusion 4||||0.51
91690675|NCT05258773|183274574|SUPERIORITY||LS Mean difference Arm A - Arm B|-11.0||||0.1406|TWO_SIDED|95.0|-25.9|3.9||An analysis of covariance (ANCOVA) model was used to assess changes from baseline at 500Hz at the Day 49 visit comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||3.9|-25.9|0.1406
91690676|NCT05258773|183274574|SUPERIORITY||LS Mean difference Arm A - Arm B|-14.4||||0.0567|TWO_SIDED|95.0|-29.24|0.45||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at the Day 49 visit comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||0.45|-29.24|0.0567
91721902|NCT01933594|183335925|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.028
91489046|NCT03572972|182850550|SUPERIORITY||Hazard Ratio (HR)|0.664|||||TWO_SIDED|95.0|0.507|0.87||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.870|0.507|
91489047|NCT03572972|182850551|SUPERIORITY||Hazard Ratio (HR)|1.204|||||TWO_SIDED|95.0|0.871|1.666||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.666|0.871|
91489048|NCT03572972|182850551|SUPERIORITY||Hazard Ratio (HR)|0.918|||||TWO_SIDED|95.0|0.691|1.218||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.218|0.691|
91527185|NCT04424290|182929706|OTHER||Adjusted mean difference|6.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-0.9|14.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||14.5|-0.9|
91527186|NCT02914184|182929711|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|1.07|||||TWO_SIDED|95.0|0.79|1.44|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.44|0.79|
91690677|NCT05258773|183274574|SUPERIORITY||LS Mean difference Arm A - Arm B|-9.0||||0.2588|TWO_SIDED|95.0|-25.0|7.1||An ANCOVA model was used to assess changes from baseline at 500Hz at EOS on Day 105 comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||7.1|-25.0|0.2588
91690678|NCT05258773|183274574|SUPERIORITY||LS Mean difference Arm A - Arm B|-13.84||||0.0979|TWO_SIDED|95.0|-30.49|2.8||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at EOS on Day 105, comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||2.80|-30.49|0.0979
91690679|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|0.9999|||||TWO_SIDED|95.0|0.8313|1.2025||||||||1.2025|0.8313|
91690680|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.2454|||||TWO_SIDED|95.0|1.0355|1.4979||||||||1.4979|1.0355|
91690681|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.2392|||||TWO_SIDED|95.0|1.0304|1.4904||||||||1.4904|1.0304|
91690682|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.2394|||||TWO_SIDED|95.0|1.0305|1.4906||||||||1.4906|1.0305|
91690683|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|0.995|||||TWO_SIDED|95.0|0.8273|1.1967||||||||1.1967|0.8273|
91690684|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.5058|||||TWO_SIDED|95.0|1.252|1.811||||||||1.8110|1.2520|
91690685|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.506|||||TWO_SIDED|95.0|1.2522|1.8113||||||||1.8113|1.2522|
91690686|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.2091|||||TWO_SIDED|95.0|1.0053|1.4541||||||||1.4541|1.0053|
91690687|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.2151|||||TWO_SIDED|95.0|1.0103|1.4614||||||||1.4614|1.0103|
91690688|NCT05277922|183274576|SUPERIORITY||Geometric mean ratio|1.2456|||||TWO_SIDED|95.0|1.0357|1.4981||||||||1.4981|1.0357|
91721903|NCT01933594|183335926|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.62
91721904|NCT01933594|183335926|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
91721905|NCT01933594|183335926|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.69
91489049|NCT03572972|182850551|SUPERIORITY||Hazard Ratio (HR)|0.771|||||TWO_SIDED|95.0|0.578|1.027||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.027|0.578|
91690689|NCT01730053|183274652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.2|||<|0.0001|TWO_SIDED|98.75|-49.2|-19.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-19.3|-49.2|<0.0001
91527187|NCT02914184|182929711|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.88|||||TWO_SIDED|95.0|0.65|1.19|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.19|0.65|
91690690|NCT01730053|183274652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-36.1|||<|0.0001|TWO_SIDED|98.75|-51.5|-20.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-20.7|-51.5|<0.0001
91690691|NCT01730053|183274652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||=|0.0453|TWO_SIDED|98.75|-45.8|5.1||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||5.1|-45.8|=0.0453
91690692|NCT01730053|183274652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.3|||=|0.0136|TWO_SIDED|98.75|-50.9|0.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||0.3|-50.9|=0.0136
91690693|NCT01730053|183274653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-23.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1.25 % level.||-23.0|-47.4|<0.0001
91690694|NCT01730053|183274653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|98.75|-45.9|-20.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-20.5|-45.9|<0.0001
91690695|NCT01730053|183274653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||=|0.0131|TWO_SIDED|98.75|-49.2|0.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||0.2|-49.2|=0.0131
91690696|NCT01730053|183274654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-17.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-17.9|-47.4|<0.0001
91690697|NCT01730053|183274654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.2|||<|0.0001|TWO_SIDED|98.75|-47.0|-17.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-47|<0.0001
91690698|NCT01730053|183274655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|98.75|-48.2|-22.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.5|-48.2|<0.0001
91690699|NCT01730053|183274655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|98.75|-45.6|-19.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.0|-45.6|<0.0001
91690700|NCT01730053|183274656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|98.75|-40.1|-18.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.3|-40.1|<0.0001
91690701|NCT01730053|183274656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.8|||<|0.0001|TWO_SIDED|98.75|-37.9|-15.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.7|-37.9|<0.0001
91690702|NCT01730053|183274657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.7|||<|0.0001|TWO_SIDED|98.75|-40.1|-21.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-21.3|-40.1|<0.0001
91690703|NCT01730053|183274657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|98.75|-38.0|-18.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.7|-38.0|<0.0001
91690704|NCT01730053|183274658|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|98.75|-43.9|-18.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.9|-43.9|<0.0001
91690705|NCT01730053|183274658|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-42.1|<0.0001
91690706|NCT01730053|183274659|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|98.75|-43.2|-22.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.4|-43.2|<0.0001
91690707|NCT01730053|183274659|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|98.75|-39.1|-17.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.3|-39.1|<0.0001
91690708|NCT01730053|183274660|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6|||<|0.0001|TWO_SIDED|98.75|-29.4|-11.8||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-11.8|-29.4|<0.0001
91690709|NCT01730053|183274660|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||<|0.0001|TWO_SIDED|98.75|-29.3|-11.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.2|-29.3|<0.0001
91690710|NCT01730053|183274661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.1|||<|0.0001|TWO_SIDED|98.75|-39.7|-16.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.5|-39.7|<0.0001
91690711|NCT01730053|183274661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.0|||<|0.0001|TWO_SIDED|98.75|-35.7|-12.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.3|-35.7|<0.0001
91690712|NCT01730053|183274662|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.5|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.9|-42.1|<0.0001
91690713|NCT01730053|183274662|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|98.75|-37.7|-12.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.2|-37.7|<0.0001
91690714|NCT01730053|183274663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.1|||<|0.0001|TWO_SIDED|98.75|-29.4|-10.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-10.7|-29.4|<0.0001
91690715|NCT01730053|183274663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.2|||<|0.0001|TWO_SIDED|98.75|-26.7|-7.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-26.7|<0.0001
91690716|NCT01730053|183274664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.4|||<|0.0001|TWO_SIDED|98.75|2.6|59.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||59.5|2.6|<0.0001
91690717|NCT01730053|183274664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||=|0.0007|TWO_SIDED|98.75|1.8|40.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||40.5|1.8|=0.0007
91690718|NCT01730053|183274665|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|98.75|2.58|88.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||88.2|2.58|<0.0001
91690719|NCT01730053|183274665|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.9|||=|0.001|TWO_SIDED|98.75|1.7|56.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||56.7|1.7|=0.001
91690720|NCT01730053|183274666|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.6|||<|0.0001|TWO_SIDED|98.75|3.6|96.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||96.2|3.6|<0.0001
91690721|NCT01730053|183274666|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.6|||<|0.0001|TWO_SIDED|98.75|2.5|53.1||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||53.1|2.5|<0.0001
91690722|NCT01730053|183274667|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|20.3|||<|0.0001|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||67.7|2.4|<0.0001
91527188|NCT02914184|182929711|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.82|||||TWO_SIDED|95.0|0.61|1.11|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_B and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.11|0.61|
91690723|NCT01730053|183274667|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.7|||=|0.0002|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||67.7|2.4|=0.0002
91690724|NCT01730053|183274668|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.9|||<|0.0001|TWO_SIDED|98.75|-38.6|-9.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-9.1|-38.6|<0.0001
91690725|NCT01730053|183274668|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.6|||=|0.0001|TWO_SIDED|98.75|-39.0|-8.2||Threshold for significance ≤ 0.0125.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-39.0|=0.0001
91721906|NCT01933594|183335927|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.28
91721907|NCT01933594|183335927|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
91489050|NCT03572972|182850552|SUPERIORITY||Hazard Ratio (HR)|0.581|||||TWO_SIDED|95.0|0.481|0.701||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.701|0.481|
91690726|NCT01730053|183274669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.4|||=|0.0311|TWO_SIDED|98.75|-1.2|16.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||16.1|-1.2|=0.0311
91690727|NCT04231825|183274723|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
91690728|NCT04231825|183274724|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
91690729|NCT04231825|183274725|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.80
91690730|NCT04231825|183274726|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
91690731|NCT04231825|183274727|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
91690732|NCT03207776|183274732|SUPERIORITY||Odds Ratio (OR)|0.8||||0.041|TWO_SIDED|95.0|0.64|0.99|||Mixed Models Analysis|||||0.99|0.64|0.041
91690733|NCT03207776|183274733|SUPERIORITY||Odds Ratio (OR)|0.99||||0.952|TWO_SIDED|95.0|0.69|1.42|||Mixed Models Analysis|||||1.42|0.69|0.952
91690734|NCT03207776|183274734|SUPERIORITY||Odds Ratio (OR)|0.91||||0.472|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||||1.17|0.71|0.472
91690735|NCT03207776|183274735|SUPERIORITY||Odds Ratio (OR)|1.14||||0.544|TWO_SIDED|95.0|0.74|1.77|||Mixed Models Analysis|||||1.77|0.74|0.544
91690736|NCT01836471|183274746|SUPERIORITY_OR_OTHER||least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.038||0.7269|TWO_SIDED|90.0|-0.5|0.08|||Mixed Models Analysis|||||0.08|-0.5|0.7269
91690737|NCT01836471|183274747|SUPERIORITY_OR_OTHER||least sqares mean|0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
91690738|NCT01836471|183274747|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|90.0|-0.04|0.13||||||||0.13|-0.04|
91690739|NCT01836471|183274747|SUPERIORITY_OR_OTHER||least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|90.0|-0.13|0.05||||||||0.05|-0.13|
91690740|NCT01836471|183274748|SUPERIORITY_OR_OTHER|||||||0.9179|||||||Mixed Models Analysis|||||||0.9179
91690741|NCT01836471|183274749|SUPERIORITY_OR_OTHER||least squares mean|-0.02|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-0.22|0.17||||||||0.17|-0.22|
91690742|NCT01836471|183274749|SUPERIORITY_OR_OTHER||least sqares mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.32|0.19||||||||0.19|-0.32|
91690743|NCT01836471|183274749|SUPERIORITY_OR_OTHER||least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
91690744|NCT01836471|183274749|SUPERIORITY_OR_OTHER||least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.43|0.09||||||||0.09|-0.43|
91690745|NCT01836471|183274750|SUPERIORITY_OR_OTHER|||||||0.793|||||||Mixed Models Analysis|||||||0.7930
91690746|NCT02069015|183274784|SUPERIORITY||Mean Difference|0.05|||<|0.001|TWO_SIDED|95.0|-4.781|6.906|||paired t-test|||||6.906|-4.781|<0.001
91690747|NCT05921903|183274805|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.52|||||TWO_SIDED|95.0|2.26|5.48|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 2.||5.48|2.26|
91690748|NCT05921903|183274805|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.04|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 3.||2.04|1.28|
91690749|NCT05921903|183274806|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.26|||||TWO_SIDED|95.0|0.94|1.69|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-A strain at Visit 4.||1.69|0.94|
91690750|NCT05921903|183274807|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.31|||||TWO_SIDED|95.0|1.01|1.68|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.68|1.01|
91721908|NCT01933594|183335927|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.81
91721909|NCT01933594|183335928|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
91721910|NCT01933594|183335928|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.22
91721911|NCT01933594|183335928|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.031
91721912|NCT01933594|183335929|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
91690751|NCT05921903|183274808|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.8|1.3|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.30|0.80|
91721913|NCT01933594|183335929|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.39
91721914|NCT01933594|183335929|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.12
91721915|NCT01933594|183335930|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.7
91721916|NCT01933594|183335930|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.51
91721917|NCT01933594|183335930|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
91721918|NCT01933594|183335931|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.78
91721919|NCT01933594|183335931|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.41
91721920|NCT01933594|183335931|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
91721921|NCT01933594|183335932|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD4||||0.69
91721922|NCT01933594|183335932|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD4||||0.27
91489051|NCT03572972|182850552|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.534|0.766||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.766|0.534|
91721923|NCT01933594|183335933|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD8||||0.81
91721924|NCT01933594|183335933|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD8||||0.81
91721925|NCT01933594|183335934|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.37
91721926|NCT01933594|183335934|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.1
91721927|NCT01933594|183335934|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.28
91721928|NCT01933594|183335934|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.16
91721929|NCT01933594|183335934|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.12
91721930|NCT01933594|183335935|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.027
91721931|NCT01933594|183335935|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
91721932|NCT01933594|183335935|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.1
91721933|NCT01933594|183335935|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
91721934|NCT01933594|183335935|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
91721935|NCT04478266|183335953|SUPERIORITY||Hazard Ratio (HR)|1.209||||0.9304|TWO_SIDED|95.0|0.939|1.557||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of De-novo metastatic disease, Postmenopausal women and Visceral metastasis according to IRT.|Letrozole + Palbociclib versus Amcenestrant + Palbociclib|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.557|0.939|0.9304
91721936|NCT04058717|183335970|OTHER||H-statistic|10.23||||0.017|TWO_SIDED||||||Kruskal-Wallis|||||||0.017
91721937|NCT04058717|183335971|OTHER||H-statistic|7.57||||0.056|TWO_SIDED||||||Kruskal-Wallis|||||||0.056
91721938|NCT04058717|183335972|OTHER||H-statistic|1.26||||0.74|TWO_SIDED||||||Kruskal-Wallis|||||||0.74
91721939|NCT04058717|183335973|OTHER||Slope|4.13||||0.248|TWO_SIDED||||||Kruskal-Wallis|||||||0.248
91721940|NCT04058717|183335974|OTHER||H-statistic|9.33||||0.025|TWO_SIDED||||||Kruskal-Wallis|||||||0.025
91721941|NCT04058717|183335975|OTHER|||||||0.289|||||||Fisher Exact|||||||0.289
91489052|NCT03572972|182850552|SUPERIORITY||Hazard Ratio (HR)|0.838|||||TWO_SIDED|95.0|0.622|1.13|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.130|0.622|
91489053|NCT03572972|182850553|SUPERIORITY||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.732|1.061||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.061|0.732|
91690752|NCT05921903|183274810|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.37|||||TWO_SIDED|95.0|2.28|4.98|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 2.||4.98|2.28|
91690753|NCT05921903|183274810|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.67|||||TWO_SIDED|95.0|1.32|2.13|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 3.||2.13|1.32|
91690754|NCT05921903|183274811|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.97|1.7|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-B strain at Visit 4.||1.70|0.97|
91690755|NCT05921903|183274812|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.29|||||TWO_SIDED|95.0|1.0|1.65|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.65|1.00|
91690756|NCT05921903|183274813|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.8|1.26|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.26|0.80|
91690757|NCT02301169|183274841|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo|Mean Difference (Final Values)|0.3748299||||0.4162|TWO_SIDED|95.0|-0.5479411|1.297601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons|t-test, 2 sided|Welch two sample t-test||||1.2976010|-0.5479411|0.4162
91690758|NCT02301169|183274842|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.|Mean Difference (Final Values)|0.1255102||||0.7887|TWO_SIDED|95.0|-0.8152493|1.0662697||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.0662697|-0.8152493|0.7887
91690759|NCT02301169|183274843|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo|Mean Difference (Final Values)|0.802381||||0.2353|TWO_SIDED|95.0|-0.5457743|2.1505362||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||2.1505362|-0.5457743|0.2353
91690760|NCT02301169|183274844|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.|Mean Difference (Final Values)|0.7656429||||0.06204|TWO_SIDED|95.0|-0.0406744|1.5719601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.5719601|-0.0406744|0.06204
91690761|NCT02301169|183274845|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.|Mean Difference (Final Values)|1.683333||||0.3386|TWO_SIDED|95.0|-1.83119|5.197857||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||5.197857|-1.831190|0.3386
91690762|NCT03762265|183274846|SUPERIORITY||Difference in percentage|5.73|STANDARD_ERROR_OF_MEAN|7.535||0.4469|TWO_SIDED|95.0|-9.037|20.5|||Cochran-Mantel-Haenszel|||P-value and 95% confidence interval (CI) were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed greater than \[\>\] 6 months prior to screening\]).||20.500|-9.037|0.4469
91489054|NCT03572972|182850553|SUPERIORITY||Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.678|0.947||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.947|0.678|
91489055|NCT03572972|182850553|SUPERIORITY||Hazard Ratio (HR)|0.882|||||TWO_SIDED|95.0|0.754|1.032||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.032|0.754|
91690763|NCT03762265|183274847|SUPERIORITY||Difference in percentage|8.13|STANDARD_ERROR_OF_MEAN|7.085||0.251|TWO_SIDED|95.0|-5.752|22.019|||Cochran-Mantel-Haenszel|||P-value and 95% CI were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed \>6 months prior to screening\]).||22.019|-5.752|0.2510
91690764|NCT02289729|183274908|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690765|NCT02289729|183274909|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690766|NCT02289729|183274910|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690767|NCT02289729|183274911|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690768|NCT02289729|183274912|SUPERIORITY|||||||0.0328|||||||t-test|||||||0.0328
91690769|NCT02289729|183274913|SUPERIORITY|||||||0.4183|||||||t-test|||||||0.4183
91690770|NCT02289729|183274914|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690771|NCT02289729|183274915|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
91690772|NCT02289729|183274916|SUPERIORITY|||||||0.0109|||||||t-test|||||||0.0109
91690773|NCT02289729|183274917|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
91690774|NCT02289729|183274918|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690775|NCT02289729|183274919|SUPERIORITY|||||||0.0002|||||||signed-rank test|||||||0.0002
91690776|NCT02289729|183274920|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690777|NCT02289729|183274921|SUPERIORITY|||||||0.0038|||||||t-test|||||||0.0038
91690778|NCT02289729|183274922|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
91690779|NCT02289729|183274923|SUPERIORITY|||||||0.0274|||||||signed-rank test|||||||0.0274
91690780|NCT02289729|183274924|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
91690781|NCT02289729|183274925|SUPERIORITY|||||||0.0006|||||||t-test|||||||0.0006
91690782|NCT02289729|183274926|SUPERIORITY|||||||0.001|||||||signed-rank test|||||||0.0010
91690783|NCT02289729|183274927|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
91690784|NCT02289729|183274928|SUPERIORITY|||||||0.0297|||||||t-test|||||||0.0297
91690785|NCT02289729|183274929|SUPERIORITY|||||||0.0279|||||||t-test|||||||0.0279
91690786|NCT02289729|183274930|SUPERIORITY|||||||0.2777|||||||t-test|||||||0.2777
91690787|NCT02289729|183274931|SUPERIORITY|||||||0.0047|||||||t-test|||||||0.0047
91690788|NCT02289729|183274932|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
91690789|NCT02289729|183274933|SUPERIORITY||||||<|0.5877|||||||t-test|||||||<0.5877
91690790|NCT02289729|183274934|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
91690791|NCT02289729|183274935|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
91690792|NCT02289729|183274936|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690793|NCT02289729|183274937|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
91690794|NCT02289729|183274938|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
91690795|NCT02289729|183274939|SUPERIORITY|||||||0.0001|||||||t-test|||||||0.0001
91690796|NCT02289729|183274940|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
91690797|NCT02289729|183274941|SUPERIORITY|||||||0.2428|||||||signed-rank test|||||||0.2428
91690798|NCT02289729|183274942|SUPERIORITY|||||||0.0687|||||||t-test|||||||0.0687
91690799|NCT02289729|183274943|SUPERIORITY|||||||0.3126|||||||t-test|||||||0.3126
91690800|NCT02289729|183274944|SUPERIORITY|||||||0.1533|||||||t-test|||||||0.1533
91690801|NCT02289729|183274945|SUPERIORITY|||||||0.8145|||||||t-test|||||||0.8145
91690802|NCT02289729|183274946|SUPERIORITY|||||||0.4048|||||||t-test|||||||0.4048
91721942|NCT02799602|183335977|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.568|0.801||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.801|0.568|<0.0001
91721943|NCT02799602|183335980|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.357|||<|0.0001|TWO_SIDED|95.0|0.302|0.421||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.421|0.302|<0.0001
91721944|NCT02799602|183335982|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.792||||0.0058|TWO_SIDED|95.0|0.66|0.95||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.950|0.660|0.0058
91721945|NCT02799602|183335984|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.609|||<|0.0001|TWO_SIDED|95.0|0.516|0.718||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.718|0.516|<0.0001
91721946|NCT02799602|183335986|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.712||||0.0081|TWO_SIDED|95.0|0.539|0.94||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.940|0.539|0.0081
91721947|NCT02799602|183335988|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio, log|0.388|||<|0.0001|TWO_SIDED|95.0|0.328|0.458||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.458|0.328|<0.0001
91489056|NCT02612129|182850597|SUPERIORITY||Least Square (LS) Mean Difference|-1.4||||0.0456|TWO_SIDED|95.0|-2.76|-0.03|||GLMM for Repeated Measures|||A general linear mixed model (GLMM) for repeated measurements was used for the analysis of NPC disease severity assessed based on the 5-domain NPCCSS scores at Month 12. The general linear mixed model analysis for repeated measures was fitted with treatment, miglustat level and visit as fixed effects including treatment-by-visit interaction and baseline score as a covariate.||-0.03|-2.76|0.0456
91690803|NCT02289729|183274947|SUPERIORITY|||||||0.8321|||||||t-test|||||||0.8321
91690804|NCT02289729|183274948|SUPERIORITY|||||||0.1945|||||||signed-rank test|||||||0.1945
91690805|NCT02289729|183274949|SUPERIORITY|||||||0.7937|||||||t-test|||||||0.7937
91690806|NCT02289729|183274950|SUPERIORITY|||||||0.0234|||||||signed-rank test|||||||0.0234
91690807|NCT02289729|183274951|SUPERIORITY|||||||0.5922|||||||t-test|||||||0.5922
91690808|NCT02289729|183274952|SUPERIORITY|||||||1|||||||t-test|||||||1.000
91489057|NCT02612129|182850598|SUPERIORITY|||||||1|||||||Chi-squared Test|||||||1.0000
91489058|NCT02612129|182850599|SUPERIORITY|||||||0.5456|||||||Chi-squared Test|||||||0.5456
91690809|NCT02289729|183274953|SUPERIORITY|||||||0.6481|||||||t-test|||||||0.6481
91690810|NCT02289729|183274954|SUPERIORITY|||||||0.6741|||||||t-test|||||||0.6741
91690811|NCT02289729|183274955|OTHER||Fisher's z|0.27846||||0.0389|TWO_SIDED|95.0|0.014175|0.495059|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.495059|0.014175|0.0389
91690812|NCT02289729|183274955|OTHER||Fisher's z|0.07359||||0.5852|TWO_SIDED|95.0|-0.188409|0.32558|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.325580|-0.188409|0.5852
91690813|NCT02289729|183274955|OTHER||Fisher's z|0.21311||||0.114|TWO_SIDED|95.0|-0.051127|0.444152|||Fisher's z Transformation|||PDQ-39 with NMSS||0.444152|-0.051127|0.1140
91690814|NCT02289729|183274955|OTHER||Fisher's z|0.29062||||0.0311|TWO_SIDED|95.0|0.026334|0.504186|||Fisher's z Transformation|||PDQ-39 with BAI||0.504186|0.026334|0.0311
91690815|NCT02289729|183274955|OTHER||Fisher's z|0.49952||||0.0002|TWO_SIDED|95.0|0.230995|0.643312|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.643312|0.230995|0.0002
91721948|NCT02799602|183335990|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|1.043||||0.7073|TWO_SIDED|95.0|0.894|1.217||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|1.217|0.894|0.7073
91721949|NCT02799602|183335992|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.688||||0.0037|TWO_SIDED|95.0|0.523|0.906||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.906|0.523|0.0037
91721950|NCT06006208|183335994|SUPERIORITY|||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
91489059|NCT02612129|182850600|SUPERIORITY|||||||0.8021|||||||Log-Rank Test|||Log-rank test had been stratified by miglustat use.||||0.8021
91489060|NCT02612129|182850601|SUPERIORITY|||||||0.3662|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 6||||0.3662
91527189|NCT02914184|182929712|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in SCR for antibodies to rota virus at month 2-4 between the Liq\_Pool group and Lyo Control group should be ≥ -10%.|SCR difference at Month 2-4|-2.49|||||TWO_SIDED|95.0|-7.15|2.63||||||Non-inferiority of Liq\_Pool group compared to Lyo Control group in terms of difference in % of subjects with anti-RV IgA titer ≥ specified cut off with its 2-sided 95% CI in initially seronegative subjects||2.63|-7.15|
91527190|NCT02914184|182929714|NON_INFERIORITY|LL of the two-sided 95% CI for the ratio of anti-RV IgA antibody GMCs between the Liq\_Pool Group and Control group should be ≥ 0.67.|GMC Ratio at At Month 2-4|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANOVA|||Non-inferiority of Liq\_Pool Group as compared to Lyo Control group in terms of the GMC ratio calculated using ANOVA model with vaccine groups and country as fixed effects||1.33|0.82|
91527191|NCT00798174|182929721|SUPERIORITY|The null hypothesis was that the azygos coil does not reduce the DFT. (A reduced DFT is superiority).||||||0.103||||||Threshold for significance is 0.05.|t-test, 2 sided|Paired t-test||"The null hypothesis is that there is no difference between the DFT using the azygos coil vs. the standard configuration.~Paired t-test (two-tailed), used due to construction of study with DFT determined in both configurations in each patient, yields p=0.103"||||0.103
91690816|NCT02289729|183274955|OTHER||Fisher's z|0.08869||||0.5146|TWO_SIDED|95.0|-0.176169|0.341163|||Fisher's z Transformation|||PDQ-39 with AS||0.341163|-0.176169|0.5146
91690817|NCT02289729|183274955|OTHER||Fisher's z|0.34688||||0.0108|TWO_SIDED|95.0|0.079996|0.546657|||Fisher's z Transformation|||PDQ-39 with PFS||0.546657|0.079996|0.0108
91690818|NCT02289729|183274955|OTHER||Fisher's z|0.22455||||0.0989|TWO_SIDED|95.0|-0.042139|0.455224|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.455224|-0.042139|0.0989
91690819|NCT02289729|183274955|OTHER||Fisher's z|0.35742||||0.006|TWO_SIDED|95.0|0.106797|0.565335|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.565335|0.106797|0.0060
91721951|NCT06006208|183335995|SUPERIORITY|||||||0.891|||||||Wilcoxon (Mann-Whitney)|||||||0.891
91690820|NCT02289729|183274955|OTHER||Fisher's z|0.00011||||0.9993|TWO_SIDED|95.0|-0.260462|0.260673|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.260673|-0.260462|0.9993
91690821|NCT02289729|183274955|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.092154|-0.565795|0.0088
91690822|NCT02289729|183274955|OTHER||Fisher's z|0.21643||||0.1222|TWO_SIDED|95.0|-0.057959|0.454911|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.454911|-0.057959|0.1222
91690823|NCT02289729|183274955|OTHER||Fisher's z|0.57423||||0.0041|TWO_SIDED|95.0|0.180247|0.74704|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.747040|0.180247|0.0041
91690824|NCT02289729|183274956|OTHER||Fisher's z|0.31946||||0.0239|TWO_SIDED|95.0|0.042257|0.534657|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.534657|0.042257|0.0239
91721952|NCT01101178|183336037|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|110.0|||||TWO_SIDED|90.0|105.21|114.47|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||114.47|105.21|
91721953|NCT01101178|183336038|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.7|||||TWO_SIDED|90.0|92.71|96.64|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||96.64|92.71|
91489061|NCT02612129|182850601|SUPERIORITY|||||||1|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 12||||1.0000
91489062|NCT02612129|182850602|SUPERIORITY||LS Mean Difference|-1.69||||0.1546|TWO_SIDED|95.0|-4.04|0.66|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 6 was analyzed using the Analysis of covariance (ANCOVA) model. ANCOVA model was fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||0.66|-4.04|0.1546
91527192|NCT02318719|182929754|SUPERIORITY||Difference of least square mean|-0.41||||0.017|TWO_SIDED|95.0|-0.74|-0.07||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 15 mg/day at Week 14||-0.07|-0.74|0.0170
91527193|NCT02318719|182929754|SUPERIORITY||Difference of least square means|-0.47||||0.0058|TWO_SIDED|95.0|-0.81|-0.14||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 20 mg/day at Week 14||-0.14|-0.81|0.0058
91721954|NCT01101178|183336039|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.9|||||TWO_SIDED|90.0|92.9|97.02|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.02|92.90|
91721955|NCT03907488|183336061|SUPERIORITY||||||<|0.005||||||One sided P-value|Log Rank|||The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.||||<0.005
91721956|NCT04338581|183336097|SUPERIORITY|||||||0.411||||||P-value is from comparing the proportion of F-VASI35 Responders between the two treatment groups using a Fisher's exact test.|Fisher Exact|||The p-value compares AMG 714 and Placebo treatment groups.||||0.411
91721957|NCT00770809|183336105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.13
91721958|NCT00770809|183336105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.072
91721959|NCT03834168|183336112|OTHER|||||||0.003|||||||Regression (Cosinor Fit)|||||||0.003
91690825|NCT02289729|183274956|OTHER||Fisher's z|0.36796||||0.0093|TWO_SIDED|95.0|0.090528|0.568388|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.568388|0.090528|0.0093
91721960|NCT03834168|183336112|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<0.001
91721961|NCT00770367|183336115|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED||||||t-test, 2 sided|||A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level \<0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.||||.37
91721962|NCT00435942|183336117|NON_INFERIORITY_OR_EQUIVALENCE|The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|Proportion free|0.97|||>|0.8|ONE_SIDED|97.5|0.93||||1-sided z-test|97.5% 1-sided confidence interval||The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|||.93|>0.80
91690826|NCT02289729|183274956|OTHER||Fisher's z|0.38627||||0.0069|TWO_SIDED|95.0|0.105875|0.582517|||Fisher's z Transformation|||PDQ-39 with NMSS||0.582517|0.105875|0.0069
91721963|NCT01033136|183336198|EQUIVALENCE|To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.||||||0.3||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Fisher Exact|||||||0.30
91690827|NCT02289729|183274956|OTHER||Fisher's z|0.70289|||<|0.0001|TWO_SIDED|95.0|0.40173|0.753097|||Fisher's z Transformation|||PDQ-39 with BAI||0.753097|0.401730|< 0.0001
91721964|NCT01033136|183336199|OTHER|||||||0.68||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom: 2, 54||Longitudinal analysis of PDSS scores||||0.68
91721965|NCT05383209|183336200|OTHER||Difference in response percentage|-5.0|||||TWO_SIDED|95.0|-24.9|13.4||||||||13.4|-24.9|
91721966|NCT05383209|183336200|OTHER||Slope|-0.2|||||TWO_SIDED|95.0|-20.6|20.6||||||||20.6|-20.6|
91721967|NCT05383209|183336201|OTHER||Difference in response percentage|5.3|||||TWO_SIDED|95.0|-13.2|26.0||||||||26.0|-13.2|
91721968|NCT02313155|183336217|SUPERIORITY_OR_OTHER||Difference|-6.6|||||TWO_SIDED|95.0|-24.858|11.592|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H1N1 Strain||11.592|-24.858|
91690828|NCT02289729|183274956|OTHER||Fisher's z|0.63758|||<|0.0001|TWO_SIDED|95.0|0.345567|0.72341|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.723410|0.345567|<0.0001
91690829|NCT02289729|183274956|OTHER||Fisher's z|0.24114||||0.0882|TWO_SIDED|95.0|-0.036024|0.476404|||Fisher's z Transformation|||PDQ-39 with AS||0.476404|-0.036024|0.0882
91690830|NCT02289729|183274956|OTHER||Fisher's z|0.67113|||<|0.0001|TWO_SIDED|95.0|0.374757|0.739016|||Fisher's z Transformation|||PDQ-39 with PFS||0.739016|0.374757|< 0.0001
91690831|NCT02289729|183274956|OTHER||Fisher's z|0.60612|||<|0.0001|TWO_SIDED|95.0|0.317572|0.708072|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.708072|0.317572|< 0.0001
91721969|NCT02313155|183336217|SUPERIORITY_OR_OTHER||Difference|-15.5|||||TWO_SIDED|95.0|-33.779|2.87|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H3N2 Strain||2.870|-33.779|
91721970|NCT02313155|183336217|SUPERIORITY_OR_OTHER||Difference|-11.8|||||TWO_SIDED|95.0|-30.048|6.547|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|B Strain||6.547|-30.048|
91721971|NCT00933933|183336247|SUPERIORITY_OR_OTHER||Clinical Specificity|99.77|||||TWO_SIDED|95.0|99.62|99.88|||Exact binomial|||||99.88|99.62|
91721972|NCT00933933|183336248|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.31|100.0|||Exact binomial|||||100.00|94.31|
91721973|NCT00933933|183336248|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|99.63|100.0|||Exact binomial|||||100.00|99.63|
91690832|NCT02289729|183274956|OTHER||Fisher's z|0.60613|||<|0.0001|TWO_SIDED|95.0|0.31758|0.708076|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.708076|0.317580|< 0.0001
91690833|NCT02289729|183274956|OTHER||Fisher's z|0.41143||||0.0036|TWO_SIDED|95.0|0.133445|0.597087|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.597087|0.133445|0.0036
91690834|NCT02289729|183274956|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.044411|-0.557217|0.0239
91690835|NCT02289729|183274956|OTHER||Fisher's z|0.64565|||<|0.0001|TWO_SIDED|95.0|0.339454|0.734221|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.734221|0.339454|< 0.0001
91489063|NCT02612129|182850602|SUPERIORITY||LS Mean Difference|-1.61||||0.2199|TWO_SIDED|95.0|-4.24|1.01|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 12 was analyzed using the ANCOVA model. ANCOVA model is fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||1.01|-4.24|0.2199
91690836|NCT02289729|183274956|OTHER||Fisher's z|0.10898||||0.7058|TWO_SIDED|95.0|-0.427482|0.588111|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.588111|-0.427482|0.7058
91690837|NCT02289729|183274957|OTHER||Fisher's z|-0.57271|||<|0.0001|TWO_SIDED|95.0|-0.689585|-0.289724|||Fisher's z Transformation|||SQLC with ZBI||-0.289724|-0.689585|< 0.0001
91690838|NCT02289729|183274957|OTHER||Fisher's z|-0.16332||||0.4142|TWO_SIDED|95.0|-0.504489|0.224771|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.224771|-0.504489|0.4142
91690839|NCT02289729|183274957|OTHER||Fisher's z|-0.48143||||0.0239|TWO_SIDED|95.0|-0.715956|-0.063481|||Fisher's z Transformation|||SQLC with Goldberg Depression||-0.063481|-0.715956|0.0239
91690840|NCT02289729|183274957|OTHER||Fisher's z|0.06326||||0.6546|TWO_SIDED|95.0|-0.210715|0.327872|||Fisher's z Transformation|||SQLC with NBL A-S||0.327872|-0.210715|0.6546
91690841|NCT02289729|183274957|OTHER||Fisher's z|0.17674||||0.2114|TWO_SIDED|95.0|-0.100105|0.425116|||Fisher's z Transformation|||SQLC with NBL C-D||0.425116|-0.100105|0.2114
91690842|NCT02289729|183274957|OTHER||Fisher's z|0.2944||||0.0374|TWO_SIDED|95.0|0.017222|0.516523|||Fisher's z Transformation|||SQLC with NBL C-R||0.516523|0.017222|0.0374
91721974|NCT00933933|183336248|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|98.18|100.0|||Exact binomial|||||100.00|98.18|
91489064|NCT02612129|182850603|SUPERIORITY||Least Square (LS) Mean Difference|-1.11||||0.0188|TWO_SIDED|95.0|-2.03|-0.19|||ANCOVA|||An ANCOVA model was fitted with treatment, baseline 5-domain NPCCSS score, and use of miglustat as covariates.||-0.19|-2.03|0.0188
91527194|NCT02318719|182929754|SUPERIORITY||Difference of least square means|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.44||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 30 mg/day at Week 14||-0.44|-1.10|<0.0001
91527195|NCT00806624|182929761|SUPERIORITY_OR_OTHER||difference in percentages|-3.5|||||TWO_SIDED|95.0|-16.2|9.4||||||||9.4|-16.2|
91690843|NCT02289729|183274957|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.092154|-0.565795|0.0088
91690844|NCT02289729|183274957|OTHER||Fisher's z|-0.13433||||0.3374|TWO_SIDED|95.0|-0.387439|0.139207|||Fisher's z Transformation|||SQLC with UPDRS-III||0.139207|-0.387439|0.3374
91690845|NCT02289729|183274957|OTHER||Fisher's z|0.17846||||0.2025|TWO_SIDED|95.0|-0.095693|0.424291|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.424291|-0.095693|0.2025
91690846|NCT02289729|183274957|OTHER||Fisher's z|0.01625||||0.9076|TWO_SIDED|95.0|-0.252613|0.282777|||Fisher's z Transformation|||SQLC with Global NMSS||0.282777|-0.252613|0.9076
91690847|NCT02289729|183274958|OTHER||Fisher's z|-0.7468|||<|0.0001|TWO_SIDED|95.0|-0.777482|-0.425693|||Fisher's z Transformation|||SQLC with ZBI||-0.425693|-0.777482|< 0.0001
91690848|NCT02289729|183274958|OTHER||Fisher's z|0.17924||||0.5347|TWO_SIDED|95.0|-0.368382|0.632178|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.632178|-0.368382|0.5347
91690849|NCT02289729|183274958|OTHER||Fisher's z|-0.06987||||0.8251|TWO_SIDED|95.0|-0.597767|0.500464|||Fisher's z Transformation|||SQLC with Goldberg Depression||0.500464|-0.597767|0.8251
91690850|NCT02289729|183274958|OTHER||Fisher's z|-0.1106||||0.4581|TWO_SIDED|95.0|-0.382323|0.179601|||Fisher's z transformation|||SQLC with NBL A-S||0.179601|-0.382323|0.4581
91690851|NCT02289729|183274958|OTHER||Fisher's z|0.00326||||0.9826|TWO_SIDED|95.0|-0.281136|0.287128|||Fisher's z Transformation|||SQLC with NBL C-D||0.287128|-0.281136|0.9826
91690852|NCT02289729|183274958|OTHER||Fisher's z|-0.10293||||0.4899|TWO_SIDED|95.0|-0.375749|0.187021|||Fisher's z Transformation|||SQLC with NBL C-R||0.187021|-0.375749|0.4899
91690853|NCT02289729|183274958|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.044411|-0.557217|0.0239
91690854|NCT02289729|183274958|OTHER||Fisher's z|-0.23658||||0.1125|TWO_SIDED|95.0|-0.484427|0.055538|||Fisher's z Transformation|||SQLC with UPDRS-III||0.055538|-0.484427|0.1125
91690855|NCT02289729|183274958|OTHER||Fisher's z|-0.13015||||0.3826|TWO_SIDED|95.0|-0.398887|0.16062|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.160620|-0.398887|0.3826
91690856|NCT02289729|183274958|OTHER||Fisher's z|0.11688||||0.4382|TWO_SIDED|95.0|-0.176724|0.390468|||Fisher's z Transformation|||SQLC with Global NMSS||0.390468|-0.176724|0.4382
91690857|NCT03123068|183274969|OTHER||||||>|0.05|||||||Mann Whitney U test|||||||>0.05
91690858|NCT02845700|183274977|SUPERIORITY|||||||0.08|||||||ANOVA|2 (time) x 2 (group) x 5 (dilution %) repeated measures ANOVA||||||.08
91690859|NCT02845700|183274978|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|t(4) = -1.19, p = .39||Post-hoc estimates of observed power for the difference between group means was calculated to be .15.||||.39
91721975|NCT00933933|183336249|SUPERIORITY_OR_OTHER||Clinical Specificity|100.0|||||TWO_SIDED|95.0|99.18|100.0|||Exact binomial|||||100.00|99.18|
91721976|NCT00933933|183336249|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.48|100.0|||Exact binomial|||||100.00|94.48|
91489065|NCT02612129|182850605|SUPERIORITY||LS Mean Difference|-5.09||||0.0536|TWO_SIDED|95.0|-10.26|0.08|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 6 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||0.08|-10.26|0.0536
91690860|NCT02845700|183274981|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|t(4) = 0.66, p = .54||Post-hoc estimates of observed power for the difference between group means was calculated to be .08.||||.54
91690861|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.93|TWO_SIDED|95.0|-0.4|0.44|||Mixed model for repeated measurements|||"Day 1, 30 min post dose.~SpO2/FiO2 and FiO2 (%) over the first 24 hours: analyzed using a linear mixed model for repeated measures (MMRM) including treatment, timepoint, treatment by timepoint interaction, investigational site and gestational age (GA) group as fixed effects, and predose values as covariates. The adjusted mean difference between treatments, and their 95% confidence intervals (CIs) at each timepoint and averaged over the first 24 hours were estimated by the model."||0.44|-0.40|0.930
91690862|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.346|TWO_SIDED|95.0|-0.59|0.21|||Mixed model for repeated measurements|||Day 1, 1 h post dose||0.21|-0.59|0.346
91690863|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.549|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 3 h post dose||0.23|-0.43|0.549
91690864|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.539|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 6 h post dose||0.23|-0.43|0.539
91690865|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.491|TWO_SIDED|95.0|-0.21|0.43|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.43|-0.21|0.491
91690866|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.623|TWO_SIDED|95.0|-0.22|0.37|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.37|-0.22|0.623
91690867|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.608|TWO_SIDED|95.0|-0.25|0.43|||Mixed model for repeated measurements|||Day 1, 24 h post dose||0.43|-0.25|0.608
91690868|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.869|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||0.30|-0.35|0.869
91690869|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.833|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Day 3, post dose||0.31|-0.38|0.833
91690870|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.772|TWO_SIDED|95.0|-0.39|0.29|||Mixed Models Analysis|||Day 5, post dose||0.29|-0.39|0.772
91690871|NCT02452476|183274992|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.963|TWO_SIDED|95.0|-0.33|0.35|||Mixed Models Analysis|||Day 7, post dose||0.35|-0.33|0.963
91690872|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.519|TWO_SIDED|95.0|-7.87|3.99|||Mixed model for repeated measurements|||Day 1, 30 min post dose||3.99|-7.87|0.519
91690873|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.282|TWO_SIDED|95.0|-2.04|6.93|||Mixed model for repeated measurements|||Day 1, 1 h post dose||6.93|-2.04|0.282
91690874|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.854|TWO_SIDED|95.0|-4.04|4.86|||Mixed model for repeated measurements|||Day 1, 3 h post dose||4.86|-4.04|0.854
91690875|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.861|TWO_SIDED|95.0|-5.0|4.19|||Mixed model for repeated measurements|||Day 1, 6 h post dose||4.19|-5.00|0.861
91690876|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.117|TWO_SIDED|95.0|-6.24|0.7|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.70|-6.24|0.117
91690877|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.185|TWO_SIDED|95.0|-4.79|0.94|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.94|-4.79|0.185
91721977|NCT00933933|183336250|SUPERIORITY_OR_OTHER||Clinical Specificity|99.83|||||TWO_SIDED|95.0|99.06|100.0|||Exact binomial|||||100.00|99.06|
91721978|NCT00933933|183336250|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.4|100.0|||Exact binomial|||||100.00|94.40|
91690878|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.678|TWO_SIDED|95.0|-5.82|3.8|||Mixed model for repeated measurements|||Day 1, 24 h post dose||3.80|-5.82|0.678
91690879|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.961|TWO_SIDED|95.0|-3.49|3.67|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||3.67|-3.49|0.961
91690880|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.544|TWO_SIDED|95.0|-6.53|3.46|||Mixed Models Analysis|||Day 3, post dose||3.46|-6.53|0.544
91690881|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.492|TWO_SIDED|95.0|-3.28|6.76|||Mixed Models Analysis|||Day 5, post dose||6.76|-3.28|0.492
91690882|NCT02452476|183274993|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.634|TWO_SIDED|95.0|-3.9|6.36|||Mixed Models Analysis|||Day 7, post dose||6.36|-3.90|0.634
91690883|NCT02452476|183274994|SUPERIORITY|Mortality or BPD incidence at 36-week PMA was compared by treatment, using Cochran-Mantel-Haenszel (CMH), adjusting for stratification gestational age (GA) group. Relative risk (RR) and its 95% confidence interval are also provided.|Relative risk|1.03||||0.811|TWO_SIDED|95.0|0.81|1.32|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of BPD||1.32|0.81|0.811
91527196|NCT00806624|182929761|SUPERIORITY_OR_OTHER||difference in percentages|-9.1|||||TWO_SIDED|95.0|-22.4|4.5||||||||4.5|-22.4|
91690884|NCT02452476|183274994|SUPERIORITY||Relative risk|1.0||||0.972|TWO_SIDED|95.0|0.81|1.25|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of Mortality/BPD||1.25|0.81|0.972
91690885|NCT02452476|183274994|SUPERIORITY||Relative risk|0.74||||0.619|TWO_SIDED|95.0|0.23|2.42|||Cochran-Mantel-Haenszel|||Week 36 PMA Mortality||2.42|0.23|0.619
91690886|NCT02452476|183274994|SUPERIORITY||Relative risk|1.46||||0.602|TWO_SIDED|95.0|0.35|6.09|||Cochran-Mantel-Haenszel|||Day 28 PNA Mortality||6.09|0.35|0.602
91721979|NCT01532089|183336252|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.39|TWO_SIDED|95.0|0.5|1.31|||Log Rank|Comparisons of PFS between arms were conducted using a stratified log-rank test.||||1.31|0.50|0.39
91721980|NCT01532089|183336253|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.33|TWO_SIDED|95.0|0.71|2.81|||Log Rank|||||2.81|0.71|0.33
91721981|NCT01532089|183336254|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
91721982|NCT01104766|183336280|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.0044|TWO_SIDED|95.0|-10.1|-1.9|||ANCOVA|||||-1.9|-10.1|0.0044
91489066|NCT02612129|182850605|SUPERIORITY||LS Mean Difference|-3.03||||0.3785|TWO_SIDED|95.0|-9.9|3.85|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 12 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||3.85|-9.90|0.3785
91489067|NCT02612129|182850606|SUPERIORITY|||||||0.6951|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Better'||||0.6951
91489068|NCT02612129|182850606|SUPERIORITY|||||||0.7542|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.7542
91489069|NCT02612129|182850606|SUPERIORITY|||||||0.488|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Better'||||0.4880
91489070|NCT02612129|182850606|SUPERIORITY|||||||0.1804|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.1804
91489071|NCT02612129|182850607|SUPERIORITY||LS Mean Difference|0.74||||0.371|TWO_SIDED|95.0|-0.92|2.4|||ANCOVA|||Change from baseline in the SARA score at Month 6 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score, and use of miglustat as covariates.||2.40|-0.92|0.3710
91489072|NCT02612129|182850607|SUPERIORITY||LS Mean Difference|0.28||||0.7899|TWO_SIDED|95.0|-1.82|2.37|||ANCOVA|||Change from baseline in the SARA score at Month 12 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score and use of miglustat as covariates.||2.37|-1.82|0.7899
91690887|NCT02452476|183274994|SUPERIORITY||Relative risk|0.56||||0.606|TWO_SIDED|95.0|0.06|5.29|||Cochran-Mantel-Haenszel|||Day 14 PNA RDS-associated mortality in 14 days of life||5.29|0.06|0.606
91489073|NCT02612129|182850608|SUPERIORITY||LS Mean Difference|-10.34||||0.6195|TWO_SIDED|95.0|-53.01|32.33|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||32.33|-53.01|0.6195
91527197|NCT00806624|182929761|SUPERIORITY_OR_OTHER||difference in percentage|-5.6|||||TWO_SIDED|95.0|-19.3|8.2||||||||8.2|-19.3|
91690888|NCT02452476|183274995|SUPERIORITY||Odds Ratio (OR)|0.69||||0.409|TWO_SIDED|95.0|0.3|1.57|||Fisher Exact|||||1.57|0.30|0.409
91690889|NCT02452476|183274996|SUPERIORITY|The percentage of patients requiring at least one rescue surfactant dose were compared by treatment group using the Fisher's exact test at 5% significance interval. Odds ratio (OR) and related exact 95% CI are also provided.|Odds Ratio (OR)|1.21||||0.689|TWO_SIDED|95.0|0.55|2.67|||Fisher Exact|||The percentage of patients requiring at least one rescue surfactant dose.||2.67|0.55|0.689
91489074|NCT02612129|182850608|SUPERIORITY||LS Mean Difference|-15.87||||0.4693|TWO_SIDED|95.0|-60.73|29.0|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||29.00|-60.73|0.4693
91527198|NCT01863043|182929808|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
91690890|NCT02452476|183274997|SUPERIORITY|||||||0.935|||||||Wilcoxon (Mann-Whitney)|||||||0.935
91690891|NCT00946920|183275013|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between treatments (degarelix versus goserelin acetate) was chosen to be -5 percentage points.|Kaplan-Meier estimate|79.6|||||TWO_SIDED|95.0|75.6|83.7||||||The cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364 was estimated by the Kaplan-Meier method. Only testosterone measurements taken at scheduled trial visits from Day 3 to Day 364 were included in the analysis. The hypothesis to test was the following: a non-inferiority assessment determined whether degarelix was non-inferior to goserelin with respect to the cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364.||83.7|75.6|
91690892|NCT02892331|183275028|SUPERIORITY|||||||0.006||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and the HIGH-INT group||||0.006
91489075|NCT02612129|182850608|SUPERIORITY||LS Mean Difference|3.2||||0.7283|TWO_SIDED|95.0|-15.71|22.12|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||22.12|-15.71|0.7283
91489076|NCT02612129|182850608|SUPERIORITY||LS Mean Difference|-5.91||||0.7708|TWO_SIDED|95.0|-47.54|35.72|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||35.72|-47.54|0.7708
91489077|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0007
91489078|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||0.0007
91489079|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||0.0011
91489080|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||0.0015
91489081|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0029|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0029
91489082|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||0.0004
91489083|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0059|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||0.0059
91489084|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||0.0002
91489085|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0002
91527199|NCT01863043|182929809|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
91527200|NCT01863043|182929810|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
91527201|NCT01863043|182929811|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
91489086|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
91690893|NCT02892331|183275028|SUPERIORITY|||||||0.045||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and MOD-INT group||||0.045
91690894|NCT02892331|183275028|SUPERIORITY|VO2 testing was not performed for one participant in the HIGH-INT group.||||||0.449|||||||ANCOVA|||Comparison between MOD-INT and High-INT groups||||0.449
91690895|NCT02892331|183275029|SUPERIORITY|||||||0.276|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.276
91690896|NCT02892331|183275029|SUPERIORITY|||||||0.633|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.633
91489087|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
91690897|NCT02892331|183275029|SUPERIORITY|||||||0.555|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.555
91690898|NCT02892331|183275030|SUPERIORITY|||||||0.37|||||||ANCOVA|||Comparison between the CON group and the HIGH-INT group||||0.370
91690899|NCT02892331|183275030|SUPERIORITY|||||||0.383|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.383
91690900|NCT02892331|183275030|SUPERIORITY|||||||0.0972|||||||ANCOVA|||Comparison for the MOD-INT and HIGH-INT groups||||0.0972
91690901|NCT02892331|183275031|SUPERIORITY|||||||0.932|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.932
91690902|NCT02892331|183275031|SUPERIORITY|||||||0.307|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.307
91690903|NCT02892331|183275031|SUPERIORITY|||||||0.376|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.376
91690904|NCT02892331|183275032|SUPERIORITY|||||||0.136|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.136
91690905|NCT02892331|183275032|SUPERIORITY|||||||0.262|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.262
91721983|NCT01104766|183336280|SUPERIORITY||Mean Difference (Final Values)|-8.8|||<|0.0001|TWO_SIDED|95.0|-12.9|-4.7|||ANCOVA|||||-4.7|-12.9|<0.0001
91721984|NCT01104766|183336280|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.0008|TWO_SIDED|95.0|-11.0|-2.9|||ANCOVA|||||-2.9|-11.0|0.0008
91690906|NCT02892331|183275032|SUPERIORITY|||||||0.715|||||||ANCOVA|||Comparison between the MOD-INT group and the HIGH-INT groups||||0.715
91690907|NCT02892331|183275033|SUPERIORITY|||||||0.056|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.056
91527202|NCT01863043|182929812|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91690908|NCT02892331|183275033|SUPERIORITY|||||||0.349|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.349
91690909|NCT02892331|183275033|SUPERIORITY|||||||0.359|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.359
91690910|NCT02892331|183275034|SUPERIORITY|||||||0.224|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.224
91690911|NCT02892331|183275034|SUPERIORITY|||||||0.199|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.199
91690912|NCT02892331|183275034|SUPERIORITY|||||||0.952|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.952
91489088|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
91489089|NCT01313858|182850695|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0002
91489090|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
91489091|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
91527203|NCT01863043|182929813|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91527204|NCT01863043|182929814|SUPERIORITY|||||||0.59|||||||Accelerated failure time regression mode|||||||0.59
91690913|NCT02892331|183275035|SUPERIORITY|||||||0.783|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.783
91690914|NCT02892331|183275035|SUPERIORITY|||||||0.098|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.098
91690915|NCT02892331|183275035|SUPERIORITY|||||||0.071|||||||ANCOVA|||Comparison between the MOD and HIGH-INT groups||||0.071
91690916|NCT02892331|183275036|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.940
91690917|NCT02892331|183275036|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.994
91690918|NCT02892331|183275036|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.940
91690919|NCT02892331|183275037|SUPERIORITY|||||||0.769|||||||ANCOVA|||Comparison of the CON and HIGH-INT groups||||0.769
91690920|NCT02892331|183275037|SUPERIORITY|||||||0.8|||||||ANCOVA|||Comparison of the CON and MOD-INT groups||||0.800
91690921|NCT02892331|183275037|SUPERIORITY|||||||0.769|||||||ANCOVA|||||||0.769
91690922|NCT02892331|183275038|SUPERIORITY|||||||1|||||||ANCOVA|||Comparison between the CON and the MOD groups||||1.000
91690923|NCT02892331|183275038|SUPERIORITY|||||||0.993|||||||ANCOVA|||Comparison of HIGH-INT and CON groups||||0.993
91690924|NCT02892331|183275038|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.994
91690925|NCT02892331|183275039|SUPERIORITY|||||||0.821|||||||ANCOVA|||Change in insulin sensitivity (CON vs. HIGH-INT)||||0.821
91690926|NCT02892331|183275039|SUPERIORITY|||||||0.985|||||||ANCOVA|||Change in insulin sensitivity (CON vs. MOD-INT)||||0.985
91690927|NCT02892331|183275039|SUPERIORITY|||||||0.856|||||||ANCOVA|||Change in insulin sensitivity (MOD-INT vs. HIGH-INT)||||0.856
91690928|NCT02892331|183275040|SUPERIORITY|||||||0.093|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.093
91721985|NCT01104766|183336281|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0004
91721986|NCT01104766|183336281|SUPERIORITY||Median Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.0001
91721987|NCT01104766|183336281|SUPERIORITY||Median Difference (Final Values)|-0.4||||0.0001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0001
91690929|NCT02892331|183275040|SUPERIORITY|||||||0.033|||||||ANCOVA|||Comparison between the CON and the MOD-INT groups||||0.033
91690930|NCT02892331|183275040|SUPERIORITY|||||||0.602|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.602
91690931|NCT02892331|183275041|SUPERIORITY|||||||0.424|||||||ANCOVA|||Change in PGC1A (CON vs. HIGH-INT)||||0.424
91690932|NCT02892331|183275041|SUPERIORITY|||||||0.308|||||||ANCOVA|||Change in PGC1A (CON vs. MOD-INT)||||0.308
91690933|NCT02892331|183275041|SUPERIORITY|||||||0.844|||||||ANCOVA|||Change in PGC1a (MOD-INT vs. HIGH-INT)||||0.844
91690934|NCT02892331|183275041|SUPERIORITY|||||||0.135|||||||ANCOVA|||Change in citrate synthase (CON vs. HIGH-INT)||||0.135
91690935|NCT02892331|183275041|SUPERIORITY|||||||0.8|||||||ANCOVA|||Change in Citrate synthase (CON vs. MOD-INT)||||0.800
91690936|NCT02892331|183275041|SUPERIORITY|||||||0.195|||||||ANCOVA|||Change in citrate synthase||||0.195
91690937|NCT02892331|183275041|SUPERIORITY|||||||0.459|||||||ANCOVA|||Change in complex I||||0.459
91690938|NCT02892331|183275041|SUPERIORITY|||||||0.213|||||||ANCOVA|||Change in complex 1 (CON vs. MOD-INT groups)||||0.213
91690939|NCT02892331|183275041|SUPERIORITY|||||||0.971|||||||ANCOVA|||Change in complex II (MOD-INT vs. HIGH-INT)||||0.971
91690940|NCT02892331|183275041|SUPERIORITY|||||||0.634|||||||ANCOVA|||Change in complex III (CON vs. HIGH-INT)||||0.634
91690941|NCT02892331|183275041|SUPERIORITY|||||||0.919|||||||ANCOVA|||Change in Complex III (CON vs. MOD-INT groups)||||0.919
91690942|NCT02892331|183275041|SUPERIORITY|||||||0.574|||||||ANCOVA|||Change in complex III||||0.574
91690943|NCT02892331|183275041|SUPERIORITY|||||||0.295|||||||ANCOVA|||Change in Complex IV (CON vs. HIGH-INT)||||0.295
91690944|NCT02892331|183275041|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change in complex IV (CON vs. MOD-INT)||||0.097
91690945|NCT02892331|183275041|SUPERIORITY|||||||0.468|||||||ANCOVA|||Change in complex IV||||0.468
91690946|NCT02892331|183275041|SUPERIORITY|||||||0.589|||||||ANCOVA|||Change in complex V||||0.589
91690947|NCT02892331|183275041|SUPERIORITY|||||||0.196|||||||ANCOVA|||Change in complex V (CON vs. MOD-INT)||||0.196
91690948|NCT02892331|183275041|SUPERIORITY|||||||0.436|||||||ANCOVA|||Change in Complex V (MOD-INT vs. HIGH-INT)||||0.436
91690949|NCT02892331|183275042|SUPERIORITY|||||||0.756|||||||ANCOVA|||Comparison of general health subscale (CON vs. HIGH INT)||||0.756
91690950|NCT02892331|183275042|SUPERIORITY|||||||0.115|||||||ANCOVA|||General Health Subscale (CON vs. MOD-INT)||||0.115
91690951|NCT02892331|183275042|SUPERIORITY|||||||0.225|||||||ANCOVA|||General Health Subscale (MOD-INT vs. HIGH-INT)||||0.225
91690952|NCT02892331|183275042|SUPERIORITY|||||||0.758|||||||ANCOVA|||Physical health Sub-scale (CON vs. HIGH-INT)||||0.758
91690953|NCT02892331|183275042|SUPERIORITY|||||||0.759|||||||ANCOVA|||Physical health subscale (CON vs. MOD-INT)||||0.759
91690954|NCT02892331|183275042|SUPERIORITY|||||||0.465|||||||ANCOVA|||Physical Health subscale (MOD-INT vs. HIGH-INT)||||0.465
91690955|NCT02892331|183275042|SUPERIORITY|||||||0.549|||||||ANCOVA|||Role Physical subscale (CON vs. HIGH-INT)||||0.549
91690956|NCT02892331|183275042|SUPERIORITY|||||||0.679|||||||ANCOVA|||Role Physical Subscale (CON vs. MOD-INT)||||0.679
91690957|NCT02892331|183275042|SUPERIORITY|||||||0.334|||||||ANCOVA|||Role Physical Subscale (MOD-INT vs. HIGH-INT)||||0.334
91690958|NCT02892331|183275042|SUPERIORITY|||||||0.273|||||||ANCOVA|||Bodily pain subscale (CON vs. HIGH-INT)||||0.273
91690959|NCT02892331|183275042|SUPERIORITY|||||||0.642|||||||ANCOVA|||Bodily pain subscale (CON vs. MOD-INT)||||0.642
91690960|NCT02892331|183275042|SUPERIORITY|||||||0.52|||||||ANCOVA|||Bodily Pain Subscale (MOD-INT vs. HIGH-INT)||||0.520
91690961|NCT02892331|183275042|SUPERIORITY|||||||0.46|||||||ANCOVA|||Vitality subscale (CON vs. HIGH-INT)||||0.460
91690962|NCT02892331|183275042|SUPERIORITY|||||||0.203|||||||ANCOVA|||Vitality sub-scale (CON vs. MOD-INT group)||||0.203
91690963|NCT02892331|183275042|SUPERIORITY|||||||0.058|||||||ANCOVA|||Vitality subscale (MOD-INT vs. HIGH-INT)||||0.058
91690964|NCT02892331|183275042|SUPERIORITY|||||||0.739|||||||ANCOVA|||Social Function subscale (CON vs. HIGH-INT)||||0.739
91690965|NCT02892331|183275042|SUPERIORITY|||||||0.059|||||||ANCOVA|||Social Function subscale (CON vs. MOD-INT)||||0.059
91690966|NCT02892331|183275042|SUPERIORITY|||||||0.038|||||||ANCOVA|||Social Function sub-scale (HIGH-INT vs. MOD-INT)||||0.0380
91690967|NCT02892331|183275042|SUPERIORITY|||||||0.95|||||||ANCOVA|||Comparison of mental health subscale (CON vs. HIGH-INT)||||0.950
91690968|NCT02892331|183275042|SUPERIORITY|||||||0.096|||||||ANCOVA|||Change in mental health subscale (CON Vs. MOD INT)||||0.096
91690969|NCT02892331|183275042|SUPERIORITY|||||||0.127|||||||ANCOVA|||Change in mental health subscale (MOD-INT vs. HIGH-INT)||||0.127
91690970|NCT02892331|183275042|SUPERIORITY|||||||0.373|||||||ANCOVA|||Change in role emotional subscale (CON vs HIGH-INT)||||0.373
91690971|NCT02892331|183275042|SUPERIORITY|||||||0.63|||||||ANCOVA|||Change in role emotional sub-scale||||0.630
91690972|NCT02892331|183275042|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in role emotional subscale (MOD vs. HIGH-INT)||||0.034
91690973|NCT02892331|183275042|SUPERIORITY|||||||0.07|||||||ANCOVA|||Change in role emotional subscale (CON vs. MOD-INT)||||0.070
91690974|NCT02892331|183275042|SUPERIORITY|||||||0.945|||||||ANCOVA|||Change in physical health sub-scale (MOD-INT vs. HIGH-INT)||||0.945
91690975|NCT02892331|183275043|SUPERIORITY|||||||0.65|||||||ANCOVA|||Change in the mental health sum scale (CON vs. HIGH-INT)||||0.650
91690976|NCT02892331|183275043|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in mental health (sum) subscale (MOD-INT vs. HIGH-INT)||||0.034
91690977|NCT02892331|183275043|SUPERIORITY|||||||0.33|||||||ANCOVA|||Change in physical health (sum)||||0.330
91690978|NCT02892331|183275043|SUPERIORITY|||||||0.297|||||||ANCOVA|||Change in physical health (sum) subscale||||0.297
91690979|NCT02892331|183275044|SUPERIORITY|||||||0.109|||||||ANCOVA|||Change in steps (CON vs. HIGH-INT)||||0.109
91690980|NCT02892331|183275044|SUPERIORITY|||||||0.099|||||||ANCOVA|||Change in steps (CON vs. MOD-INT)||||0.099
91690981|NCT02892331|183275044|SUPERIORITY|||||||0.947|||||||ANCOVA|||Change in steps (MOD-INT vs. HIGH-INT)||||0.947
91690982|NCT02654054|183275070|SUPERIORITY||Odds Ratio (OR)|56.79|||<|0.001|TWO_SIDED|95.0|23.002|140.227||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||140.227|23.002|< 0.001
91527205|NCT01863043|182929815|SUPERIORITY|||||||0.64|||||||Accelerated failure time regression mode|||||||0.64
91690983|NCT02654054|183275070|SUPERIORITY||Odds Ratio (OR)|22.98|||<|0.001|TWO_SIDED|95.0|10.466|50.451||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||50.451|10.466|< 0.001
91690984|NCT02654054|183275071|SUPERIORITY||LS Mean of Difference|-222.3|STANDARD_ERROR_OF_MEAN|20.77|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
91690985|NCT02654054|183275071|SUPERIORITY||LS Mean of Difference|-177.5|STANDARD_ERROR_OF_MEAN|18.24|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
91690986|NCT02654054|183275072|SUPERIORITY||Between-Group Difference (%)|79.6|||<|0.001|TWO_SIDED|95.0|71.13|88.16||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||88.16|71.13|< 0.001
91690987|NCT02654054|183275072|SUPERIORITY||Between-Group Difference (%)|52.4|||<|0.001|TWO_SIDED|95.0|44.11|60.76||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||60.76|44.11|< 0.001
91690988|NCT02654054|183275073|SUPERIORITY||LS Mean of Difference|-234.0|STANDARD_ERROR_OF_MEAN|19.27|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91690989|NCT02654054|183275073|SUPERIORITY||LS Mean of Difference|-192.5|STANDARD_ERROR_OF_MEAN|16.7|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91690990|NCT02654054|183275074|SUPERIORITY||LS Mean of Difference|-240.8|STANDARD_ERROR_OF_MEAN|21.69|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91690991|NCT02654054|183275074|SUPERIORITY||LS Mean of Difference|-198.2|STANDARD_ERROR_OF_MEAN|18.76|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91690992|NCT02654054|183275075|SUPERIORITY||Between-Group Difference (%)|49.7|||<|0.001|TWO_SIDED|95.0|30.27|69.18||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||69.18|30.27|< 0.001
91690993|NCT02654054|183275075|SUPERIORITY||Between-Group Difference (%)|45.4|||<|0.001|TWO_SIDED|95.0|26.9|63.92||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||63.92|26.90|< 0.001
91690994|NCT02654054|183275076|SUPERIORITY||LS Mean of Difference|-190.0|STANDARD_ERROR_OF_MEAN|22.59|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91690995|NCT02654054|183275076|SUPERIORITY||LS Mean of Difference|-116.2|STANDARD_ERROR_OF_MEAN|19.7|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91690996|NCT04871776|183275077|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||How vs Usual Care|We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.14|0.67|
91690997|NCT04871776|183275077|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.28||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.28|0.81|
91690998|NCT04871776|183275077|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.96|1.51||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.51|0.96|
91690999|NCT04871776|183275078|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.67|1.01||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.01|0.67|
91691000|NCT04871776|183275078|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.23|0.87|
91691001|NCT04871776|183275078|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.06|1.49||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.49|1.06|
91527206|NCT01863043|182929816|SUPERIORITY|||||||0.95|||||||Accelerated failure time regression mode|||||||0.95
91527207|NCT01863043|182929817|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91691002|NCT02490631|183275081|SUPERIORITY|||||||0.456|||||||Chi-squared|||||||0.456
91691003|NCT02490631|183275082|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||.019
91691004|NCT06389487|183275083|NON_INFERIORITY|Non-Inferiority (NI) was to be demonstrated if the upper limit of the 95% confidence interval (CI) of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was less than or equal to (≤) 1.5.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||0.81|0.64|
91691005|NCT06389487|183275084|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-9.33|||||TWO_SIDED|95.0|-14.55|-4.1|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||-4.10|-14.55|
91691006|NCT06389487|183275085|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤1.5.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.65|0.82|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||0.82|0.65|
91691007|NCT06389487|183275086|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-10.03|||||TWO_SIDED|95.0|-15.26|-4.8|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||-4.80|-15.26|
91692146|NCT01262872|183279148|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|6.4|||||TWO_SIDED|95.0|-17.8|25.7||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-17.8|
91692147|NCT01262872|183279148|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|2.5|||||TWO_SIDED|95.0|-22.6|22.5||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||22.5|-22.6|
91692148|NCT01262872|183279148|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|4.5|||||TWO_SIDED|95.0|-21.4|25.0||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.0|-21.4|
91692149|NCT01262872|183279148|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|5.3|||||TWO_SIDED|95.0|-19.2|24.8||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||24.8|-19.2|
91691008|NCT03851406|183275177|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
91691009|NCT03851406|183275178|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
91691010|NCT03851406|183275179|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||> 0.99
91691011|NCT03851406|183275179|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||> 0.99
91691012|NCT03851406|183275180|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
91691013|NCT03851406|183275180|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
91691014|NCT03851406|183275181|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.25
91691015|NCT03851406|183275181|OTHER|||||||0.63||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.63
91691016|NCT03851406|183275182|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
91691017|NCT03851406|183275182|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
91527208|NCT01863043|182929818|SUPERIORITY|||||||0.23|||||||Accelerated failure time regression mode|||||||0.23
91527209|NCT01863043|182929819|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
91527210|NCT01863043|182929820|SUPERIORITY|||||||0.01|||||||Accelerated failure time regression mode|||||||0.01
91691018|NCT03851406|183275183|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
91691019|NCT03851406|183275183|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.25
91691020|NCT03851406|183275184|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||>0.99
91691021|NCT03851406|183275184|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
91691022|NCT03851406|183275185|OTHER|||||||0.75||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.75
91691023|NCT03851406|183275185|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
91691024|NCT02502149|183275198|OTHER||Adjusted Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.24|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.24|0.93|
91691025|NCT02502149|183275199|OTHER||Adjusted Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.87|1.16|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.16|0.87|
91691026|NCT03871543|183275344|OTHER|Statistical Difference|Mean difference|0.159|STANDARD_ERROR_OF_MEAN|0.287|||ONE_SIDED|95.0|-0.402||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Upper Lid|||-0.402|
91691027|NCT03871543|183275344|OTHER|Statistical Difference|Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.289|||ONE_SIDED|95.0|-0.328||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Lower Lid|||-0.328|
91691028|NCT03871543|183275345|OTHER|Statistical difference|Mean Ratio|0.918|||||ONE_SIDED|95.0||1.227|||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean ratio was calculated as Symptomatic divided by Asymptomatic|||1.227||
91691029|NCT03871543|183275346|OTHER|Statistical difference|Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.019|||ONE_SIDED|95.0||0.022|||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|||0.022||
91691030|NCT03871543|183275347|OTHER|Statistical difference|Mean Difference|1.185|STANDARD_ERROR_OF_MEAN|3.483|||ONE_SIDED|95.0|-4.613||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic||||-4.613|
91691031|NCT03871543|183275348|OTHER|Statistical difference|Mean Ratio|1.984|||||ONE_SIDED|95.0|1.198||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Upper Lid|||1.198|
91691032|NCT03871543|183275348|OTHER|Statistical Difference|Mean Ratio|1.8|||||ONE_SIDED|95.0|1.093||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Lower Lid|||1.093|
91691033|NCT03871543|183275349|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1416||||0.3446|TWO_SIDED|95.0|-0.4148|0.1551|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1551|-0.4148|0.3446
91691034|NCT03871543|183275350|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0887||||0.5556|TWO_SIDED|95.0|-0.207|0.3694|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3694|-0.2070|0.5556
91691035|NCT03871543|183275351|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2052||||0.1676|TWO_SIDED|95.0|-0.4676|0.0905|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0905|-0.4676|0.1676
91721988|NCT05452239|183336296|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-4); 2. Change in MMDs (Weeks 1-12); 3. Change in MHDs (Weeks 1-4); 4. Change in MHDs (Weeks 1-12); 5. Participants not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Weeks 1-4), 6. Participants not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Weeks 1-12), 7. Change in average Daily Pain assessment score (Weeks 1-2); 8. Change in MAMDs (Weeks 1-4), 9. Change in MAMDs (Weeks 1-12).|Least Square (LS) Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-4.16|-2.23||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 1 of testing order.|Mixed model for repeated measures|||Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with Baseline number of MMDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MMDs at baseline-by-month were included.||-2.23|-4.16|<0.0001
91721989|NCT05452239|183336297|OTHER||LS Mean Difference|-2.94|STANDARD_ERROR_OF_MEAN|0.469|<|0.0001|TWO_SIDED|95.0|-3.86|-2.02||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 2 of testing order.|Mixed model for repeated measures|||Analysis was performed using a REML-based MMRM with Baseline number of MMDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MMDs at baseline-by-month were included.||-2.02|-3.86|<0.0001
91721990|NCT05452239|183336298|OTHER||LS Mean Difference|-3.15|STANDARD_ERROR_OF_MEAN|0.471|<|0.0001|TWO_SIDED|95.0|-4.07|-2.22||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 3 of testing order.|Mixed model for repeated measures||Change From Baseline in the Number of MHDs at Weeks 1 to 4: Eptinezumab vs. Placebo|Analysis was performed using a REML-based MMRM with Baseline number of MHDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MHDs at baseline-by-month were included.||-2.22|-4.07|<0.0001
91721991|NCT05452239|183336298|OTHER||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.83|-2.02||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 4 of testing order.|Mixed model for repeated measures||Change From Baseline in the Number of MHDs at Weeks 1 to 12 (averaged over three 4-week intervals): Eptinezumab vs. Placebo|Analysis was performed using a REML-based MMRM with Baseline number of MHDs as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of MHDs at baseline-by-month were included.||-2.02|-3.83|<0.0001
91691036|NCT03871543|183275352|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0903||||0.5483|TWO_SIDED|95.0|-0.2054|0.3709|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3709|-0.2054|0.5483
91691037|NCT03871543|183275353|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2679||||0.0719|TWO_SIDED|95.0|-0.5205|0.0278|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0278|-0.5205|0.0719
91691038|NCT03871543|183275354|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.3434||||0.019|TWO_SIDED|95.0|-0.5786|0.0554|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0554|-0.5786|0.0190
91691039|NCT03871543|183275355|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2975||||0.042|TWO_SIDED|95.0|-0.541|-0.0078|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||-0.0078|-0.5410|0.0420
91691040|NCT03871543|183275356|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.127||||0.3973|TWO_SIDED|95.0|-0.1696|0.4024|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.4024|-0.1696|0.3973
91691041|NCT03871543|183275357|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.021||||0.8894|TWO_SIDED|95.0|-0.3094|0.271|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.2710|-0.3094|0.8894
91691042|NCT03871543|183275358|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0762||||0.6129|TWO_SIDED|95.0|-0.219|0.3585|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3585|-0.2190|0.6129
91691043|NCT03871543|183275359|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1402||||0.3493|TWO_SIDED|95.0|-0.4137|0.1565|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1565|-0.4137|0.3493
91527211|NCT01863043|182929821|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91691044|NCT03871543|183275360|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1192||||0.427|TWO_SIDED|95.0|-0.3958|0.1772|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1772|-0.3958|0.4270
91691045|NCT00663793|183275391|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon sign-rank|||||||<0.05
91691046|NCT00663793|183275392|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study.|||||<|0.05||95.0|||||Wilcoxon sign-rank|||||||<0.05
91691047|NCT00663793|183275393|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Area-under-the-curve for serum estradiol||||0.05
91691048|NCT03051100|183275443|SUPERIORITY||Least squares mean difference|-60.5|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-68.0|-53.0|||ANCOVA||Triplet therapy minus placebo|||-53.0|-68.0|<0.001
91691049|NCT03051100|183275444|SUPERIORITY||Least squares mean difference|-58.7|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-64.9|-52.6|||ANCOVA||Triplet therapy minus placebo|non-HDL-C||-52.6|-64.9|<0.001
91691050|NCT03051100|183275444|SUPERIORITY||Least squares mean difference|-46.0|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-51.6|-40.4|||ANCOVA||Triplet therapy minus placebo|TC||-40.4|-51.6|<0.001
91691051|NCT03051100|183275444|SUPERIORITY||Least squares mean difference|-54.1|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-59.7|-48.6|||ANCOVA|||apoB||-48.6|-59.7|<0.001
91691052|NCT03051100|183275444|SUPERIORITY||Least squares mean difference|-36.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-49.7|-22.8|||ANCOVA|||TG||-22.8|-49.7|<0.001
91691053|NCT03051100|183275444|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|2.7|=|0.588|TWO_SIDED|95.0|-7.0|4.0|||ANCOVA|||HDL-C||4.0|-7.0|=0.588
91691054|NCT03051100|183275445|SUPERIORITY||Median treatment difference|-41.9|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-60.0|-21.4|||Wilcoxon rank sum test|||||-21.4|-60.0|<0.001
91691055|NCT03051100|183275446|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91691056|NCT03051100|183275447|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91691057|NCT03335475|183275511|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
91691058|NCT03335475|183275512|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
91691059|NCT03335475|183275513|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
91691060|NCT04886596|183275514|OTHER|VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.|VE|82.58|||||TWO_SIDED|96.95|57.89|94.08|||Poisson regression method||VE in terms of occurrence of RSV-confirmed LRTD was evaluated using the conditional exact binomial method based on the Poisson model|To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA||94.08|57.89|
91691061|NCT04886596|183275515|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|62.91|||||TWO_SIDED|97.5|46.74|74.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||74.79|46.74|
91691062|NCT04886596|183275515|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.18|||||TWO_SIDED|97.5|48.19|80.04|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.04|48.19|
91691063|NCT04886596|183275516|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.76|||||TWO_SIDED|97.5|51.82|79.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||79.11|51.82|
91691064|NCT04886596|183275516|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.12|||||TWO_SIDED|97.5|48.09|80.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.00|48.09|
91691065|NCT04886596|183275517|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|69.83|||||TWO_SIDED|97.5|42.18|85.72|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||85.72|42.18|
91691066|NCT04886596|183275517|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|58.57|||||TWO_SIDED|97.5|35.9|74.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||74.11|35.90|
91691067|NCT04886596|183275518|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|55.12|||||TWO_SIDED|97.5|16.52|77.52|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||77.52|16.52|
91691068|NCT04886596|183275518|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|73.58|||||TWO_SIDED|97.5|55.1|85.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||85.40|55.10|
91691069|NCT04886596|183275519|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|18.41|||||TWO_SIDED|95.0|-19.1|44.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season)|To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.||44.33|-19.10|
91691070|NCT04886596|183275520|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.78|||||TWO_SIDED|95.0|40.73|71.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.96|40.73|
91691071|NCT04886596|183275520|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.98|||||TWO_SIDED|95.0|44.32|80.16|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||80.16|44.32|
91691072|NCT04886596|183275520|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|36.24|||||TWO_SIDED|95.0|-93.99|82.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.47|-93.99|
91691073|NCT04886596|183275520|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.56|||||TWO_SIDED|95.0|49.33|78.64|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.64|49.33|
91691074|NCT04886596|183275520|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.25|||||TWO_SIDED|95.0|40.49|79.55|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||79.55|40.49|
91691075|NCT04886596|183275520|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|32.81|||||TWO_SIDED|95.0|-108.42|81.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||81.73|-108.42|
91691076|NCT04886596|183275521|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|80.64|||||TWO_SIDED|95.0|55.9|92.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||92.73|55.90|
91721992|NCT05452239|183336299|OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|2.18|4.94||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 5 of testing order.|Regression, Logistic||Percentage of participants not fulfilling the ICHD-3 Diagnostic Criteria for CM nor MOH at Weeks 1 to 4: Eptinezumab vs. Placebo|The logistic regression model with baseline MMDs as a covariate, and treatment group (eptinezumab versus placebo), country and previous treatment failures (≤2, \>2) as categorical variables based on the eDiary data collected over Weeks 1-4, Weeks 5-8, Weeks 9-12 and over Weeks 1-12 separately, was fitted using the maximum likelihood method and the logit link function.||4.94|2.18|<0.0001
91721993|NCT05452239|183336299|OTHER||Odds Ratio (OR)|3.05|||<|0.0001|TWO_SIDED|95.0|1.93|4.9||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 6 of testing order.|Regression, Logistic||Percentage of participants not fulfilling the ICHD-3 Diagnostic Criteria for CM nor MOH at Weeks 1 - 12 (averaged over three 4-week intervals): Eptinezumab vs. Placebo|The logistic regression model with baseline MMDs as a covariate, and treatment group (eptinezumab versus placebo), country and previous treatment failures (≤2, \>2) as categorical variables based on the eDiary data collected over Weeks 1-4, Weeks 5-8, Weeks 9-12 and over Weeks 1-12 separately, was fitted using the maximum likelihood method and the logit link function.||4.90|1.93|<0.0001
91691077|NCT04886596|183275521|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.39|||||TWO_SIDED|95.0|36.44|77.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||77.70|36.44|
91691078|NCT04886596|183275521|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.15|||||TWO_SIDED|95.0|7.06|71.59|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.59|7.06|
91691079|NCT04886596|183275521|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|54.92|||||TWO_SIDED|95.0|27.85|72.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||72.98|27.85|
91691080|NCT04886596|183275521|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.51|||||TWO_SIDED|95.0|22.35|88.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.79|22.35|
91691081|NCT04886596|183275522|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.86|||||TWO_SIDED|95.0|57.62|90.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||90.48|57.62|
91691082|NCT04886596|183275522|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.59|||||TWO_SIDED|95.0|34.0|75.1|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||75.10|34.00|
91691083|NCT04886596|183275522|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.91|||||TWO_SIDED|95.0|8.51|71.97|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.97|8.51|
91691084|NCT04886596|183275522|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.33|||||TWO_SIDED|95.0|33.59|74.94|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||74.94|33.59|
91691085|NCT04886596|183275522|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.4|||||TWO_SIDED|95.0|24.64|89.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||89.08|24.64|
91691086|NCT04886596|183275523|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.75|||||TWO_SIDED|95.0|57.95|89.26|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.||89.26|57.95|
91691087|NCT04886596|183275523|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.63|||||TWO_SIDED|95.0|52.47|77.95|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.||77.95|52.47|
91691088|NCT04886596|183275523|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|46.76|74.11|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.||74.11|46.76|
91691089|NCT04886596|183275523|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.49|||||TWO_SIDED|95.0|52.27|77.86|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.86|52.27|
91489092|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
91489093|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||<0.0001
91489094|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
91489095|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
91691090|NCT04886596|183275523|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.66|||||TWO_SIDED|95.0|51.71|78.34|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.34|51.71|
91527212|NCT01863043|182929822|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91527213|NCT01863043|182929824|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91691091|NCT04886596|183275524|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.49|||||TWO_SIDED|95.0|47.54|79.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||79.40|47.54|
91691092|NCT04886596|183275524|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.88|||||TWO_SIDED|95.0|34.81|74.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||74.98|34.81|
91489096|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
91489097|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||<0.0001
91489098|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
91489099|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
91489100|NCT01313858|182850695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
91489101|NCT01313858|182850696|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||0.0003
91489102|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
91489103|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
91527214|NCT01863043|182929825|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
91527215|NCT01863043|182929826|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
91527216|NCT01863043|182929827|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
91527217|NCT01863043|182929828|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
91527218|NCT01863043|182929829|SUPERIORITY|||||||0.97|||||||Accelerated failure time regression mode|||||||0.97
91527219|NCT01863043|182929830|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
91527220|NCT01863043|182929831|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91527221|NCT01863043|182929832|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91527222|NCT01863043|182929833|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91489104|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
91489105|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
91489106|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
91489107|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
91489108|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
91489109|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
91489110|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
91489111|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
91489112|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
91489113|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
91489114|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
91489115|NCT01313858|182850696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
91691093|NCT04886596|183275524|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|72.55|||||TWO_SIDED|95.0|54.34|84.37|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.37|54.34|
91489116|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
91489117|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
91489118|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
91489119|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
91489120|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
91489121|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
91489122|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
91489123|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
91489124|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
91489125|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
91489126|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
91489127|NCT01313858|182850697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
91489128|NCT03689530|182850708|SUPERIORITY|||||||0.7436|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.7436
91489129|NCT03689530|182850709|SUPERIORITY|||||||0.1212|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1212
91489130|NCT03689530|182850710|SUPERIORITY|||||||0.8839|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8839
91489131|NCT03689530|182850711|SUPERIORITY|||||||0.1137|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1137
91489132|NCT03689530|182850712|SUPERIORITY|||||||0.0162|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0162
91489133|NCT03689530|182850714|SUPERIORITY|||||||0.2117|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.2117
91489134|NCT03689530|182850715|SUPERIORITY|||||||0.4169|||||||Mixed Models Analysis|||||||0.4169
91691094|NCT04886596|183275524|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.99|||||TWO_SIDED|95.0|37.17|78.01|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.01|37.17|
91691095|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.48|||||TWO_SIDED|95.0|38.62|76.74|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||76.74|38.62|
91691096|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.73|||||TWO_SIDED|95.0|45.1|78.14|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||78.14|45.10|
91691097|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.14|||||TWO_SIDED|95.0|45.71|82.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.33|45.71|
91691098|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.88|||||TWO_SIDED|95.0|31.35|82.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.48|31.35|
91691099|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.16|||||TWO_SIDED|95.0|41.08|79.17|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||79.17|41.08|
91691100|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|71.19|||||TWO_SIDED|95.0|51.92|83.65|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.65|51.92|
91489135|NCT03689530|182850716|SUPERIORITY|||||||0.8785|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8785
91527223|NCT01863043|182929834|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91489136|NCT03689530|182850717|SUPERIORITY|||||||0.1006|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1006
91489137|NCT03689530|182850718|SUPERIORITY|||||||0.7168|||||||Mixed Models Analysis|||||||0.7168
91489138|NCT03689530|182850719|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0001
91489139|NCT03689530|182850720|OTHER|Single group analysis for peer support group only|Mean|3.799|STANDARD_DEVIATION|0.885|||TWO_SIDED|||||||||||||
91489140|NCT03689530|182850721|OTHER|Single group analysis for peer support group only|Mean|3.732|STANDARD_DEVIATION|0.985|||TWO_SIDED|||||||||||||
91527224|NCT01863043|182929835|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
91527225|NCT01863043|182929836|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||||||0.59
91527226|NCT01863043|182929837|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||||||0.888
91691101|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|75.94|||||TWO_SIDED|95.0|54.11|88.54|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.54|54.11|
91691102|NCT04886596|183275525|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|69.85|||||TWO_SIDED|95.0|37.51|87.05|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||87.05|37.51|
91691103|NCT04886596|183275526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-153.57|||||TWO_SIDED|95.0|-16322.97|88.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||88.00|-16322.97|
91691104|NCT04886596|183275526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|70.07|||||TWO_SIDED|95.0|43.89|85.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.33|43.89|
91691105|NCT04886596|183275526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.04|||||TWO_SIDED|95.0|42.89|74.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||74.08|42.89|
91691106|NCT04886596|183275526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|13.62|||||TWO_SIDED|95.0|-6751.38|98.91|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||98.91|-6751.38|
91691107|NCT04886596|183275526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|74.32|||||TWO_SIDED|95.0|49.33|88.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.31|49.33|
91691108|NCT04886596|183275526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.79|||||TWO_SIDED|95.0|46.1|77.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.75|46.10|
91721994|NCT05452239|183336300|OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|-0.39|-0.22||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 7 of testing order.|ANCOVA|||Analysis of covariance (ANCOVA) was performed with the average Daily Pain at baseline as a covariate and including treatment group, country, and previous treatment failures, as categorical variables.||-0.22|-0.39|<0.0001
91721995|NCT05452239|183336301|OTHER||LS Mean Difference|-3.63|STANDARD_ERROR_OF_MEAN|0.487|<|0.0001|TWO_SIDED|95.0|-4.59|-2.67||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 8 of testing order.|Mixed model for repeated measures||Change from baseline in monthly days with acute migraine medication use at Weeks 1 to 4: Eptinezumab vs. Placebo|Analysis was performed using a REML-based MMRM with Baseline number of monthly days with acute migraine medication use as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of monthly days with acute migraine medication use at baseline-by-month were included.||-2.67|-4.59|<0.0001
91489141|NCT03689530|182850722|OTHER|Single group analysis for peer support group only|Mean|6.222|STANDARD_DEVIATION|1.083|||TWO_SIDED|||||||||||||
91527227|NCT01863043|182929838|SUPERIORITY|||||||0.694|||||||Regression, Linear|||||||0.694
91691109|NCT04886596|183275527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
91721996|NCT05452239|183336301|OTHER||LS Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.447|<|0.0001|TWO_SIDED|95.0|-4.23|-2.48||Testing continued only if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 9 of testing order.|Mixed model for repeated measures||Change from baseline in monthly days with acute migraine medication use at Weeks 1 - 12 (averaged over three 4-week intervals): Eptinezumab vs. Placebo|Analysis was performed using a REML-based MMRM with Baseline number of monthly days with acute migraine medication use as a continuous covariate and treatment group (eptinezumab versus placebo), month (Weeks 1-4, 5-8, 9-12), country, and previous treatment failures (≤2; \>2) as factors. The interaction terms treatment-by-month and previous treatment failures-by-month as well as number of monthly days with acute migraine medication use at baseline-by-month were included.||-2.48|-4.23|<0.0001
91489142|NCT03689530|182850723|OTHER|Single group analysis for peer support group only|Mean|6.179|STANDARD_DEVIATION|1.141|||TWO_SIDED|||||||||||||
91489143|NCT03689530|182850724|SUPERIORITY|||||||0.9126|||||||Mixed Models Analysis|||||||0.9126
91489144|NCT03689530|182850725|SUPERIORITY|||||||0.7405|||||||Mixed Models Analysis|||||||0.7405
91489145|NCT03689530|182850726|SUPERIORITY|||||||0.5956|||||||Mixed Models Analysis|||||||0.5956
91489146|NCT03689530|182850727|SUPERIORITY|||||||0.3341|||||||Mixed Models Analysis|||||||0.3341
91527228|NCT01863043|182929839|SUPERIORITY|||||||0.248|||||||general linear mixed model|||||||0.248
91489147|NCT03689530|182850728|SUPERIORITY|||||||0.2049|||||||Mixed Models Analysis|||||||0.2049
91721997|NCT00207740|183336365|SUPERIORITY_OR_OTHER|||||||0.802||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|ANCOVA|||The null hypothesis was that the endpoint for placebo is the same as that for combined 100 mg and 200 mg golimumab. Assuming a standard deviation of 23%, there is 86% power to detect a 10% difference at a 0.05 significance level.||||0.802
91489148|NCT03689530|182850729|SUPERIORITY|||||||0.0335|||||||Mixed Models Analysis|||||||0.0335
91527229|NCT01863043|182929840|SUPERIORITY|||||||0.694|||||||general linear mixed model|||||||0.694
91489149|NCT03689530|182850730|SUPERIORITY|||||||0.3219|||||||Mixed Models Analysis|||||||0.3219
91489150|NCT03689530|182850731|SUPERIORITY|||||||0.5223|||||||Mixed Models Analysis|||||||0.5223
91489151|NCT01392443|182850732|OTHER|||||||0.0007|||||||single-sample biniminal test|||||||0.0007
91489152|NCT01977794|182850737|SUPERIORITY_OR_OTHER||||||<|0.001||||||P value in both groups (Amlodipine failed and Bisoprolol failed) for comparison of SBP after 18 weeks versus baseline|Paired t test|||For each group (Amlodipine failed and Bisoprolol failed) SBP after 18 weeks compared to baseline (under monotherapy). Superiority was assessed between FDC and monotherapies.||||<0.001
91489153|NCT01895062|182850742|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.022
91489154|NCT00533897|182850746|SUPERIORITY_OR_OTHER||estimate of difference|9.59||||0.119|TWO_SIDED|95.0|0.83|18.34||There was no adjustment made for multiple comparisons.|Chi-squared, Corrected|||A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided.||18.34|0.83|0.119
91489155|NCT00533897|182850747|SUPERIORITY_OR_OTHER||Estimate of Difference|4.88|||||TWO_SIDED|95.0|-4.5|14.25||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||14.25|-4.50|
91489156|NCT00533897|182850751|SUPERIORITY_OR_OTHER||Estimate of Difference|0.11|||||TWO_SIDED|95.0|-8.21|8.43||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||8.43|-8.21|
91527230|NCT01863043|182929841|SUPERIORITY|||||||0.195|||||||Regression, Linear|||||||0.195
91527231|NCT01987596|182929847|SUPERIORITY|||||||1|||||||McNemar|||||||1.00
91527232|NCT01987596|182929848|SUPERIORITY||||||<|0.0001|||||||ANOVA|||two-period crossover design analysis||||<0.0001
91527233|NCT01987596|182929849|SUPERIORITY||||||<|0.0001|||||||ANOVA|||2 treatment, 2 periiod cross-over analysis||||<0.0001
91527234|NCT02632786|182929852|SUPERIORITY||Risk Ratio (RR)|0.82||||0.319|TWO_SIDED|95.0|0.55|1.21|||Cochran-Mantel-Haenszel|||||1.21|0.55|0.3190
91527235|NCT02632786|182929853|SUPERIORITY||Mean Difference (Net)|-0.78||||0.5563|TWO_SIDED|95.0|-3.37|1.81|||Mixed Models Analysis|||||1.81|-3.37|0.5563
91527236|NCT02632786|182929854|SUPERIORITY||Mean Difference (Net)|5.0||||0.8992|TWO_SIDED|95.0|-11.5|23.0|||ANCOVA|||||23.00|-11.50|0.8992
91527237|NCT02632786|182929855|SUPERIORITY||Risk Ratio (RR)|1.54||||0.3529|TWO_SIDED|95.0|0.6|3.94|||Cochran-Mantel-Haenszel|||||3.94|0.60|0.3529
91721998|NCT00207740|183336365|SUPERIORITY_OR_OTHER|||||||0.945||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.945
91721999|NCT00207740|183336365|SUPERIORITY_OR_OTHER|||||||0.717||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.717
91489157|NCT01065597|182850859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||0.001
91489158|NCT01065597|182850860|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||>0.05
91489159|NCT01065597|182850862|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91489160|NCT02653872|182850863|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with verapamil over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|153.4|||||TWO_SIDED|90.0|136.16|172.83|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||172.83|136.16|
91489161|NCT02653872|182850863|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with itraconazole over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|60.66|||||TWO_SIDED|90.0|53.84|68.34|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||68.34|53.84|
91489162|NCT02653872|182850864|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with verapamil over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|132.25|||||TWO_SIDED|90.0|121.78|143.64|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||143.64|121.78|
91527238|NCT02632786|182929856|SUPERIORITY||Mean Difference (Net)|-0.6||||0.757|TWO_SIDED|95.0|-4.2|3.0|||Mixed Models Analysis|||||3.0|-4.2|0.7570
91489163|NCT02653872|182850864|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with itraconazole over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|113.7|||||TWO_SIDED|90.0|104.69|123.49|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||123.49|104.69|
91489164|NCT02653872|182850865|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with verapamil over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|133.51|||||TWO_SIDED|90.0|122.7|145.29|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||145.29|122.70|
91489165|NCT02653872|182850865|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with itraconazole over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|112.45|||||TWO_SIDED|90.0|103.34|122.37|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||122.37|103.34|
91722000|NCT00207740|183336365|SUPERIORITY_OR_OTHER|||||||0.357||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.357
91489166|NCT04873700|182850879|SUPERIORITY||||||=|0.0701|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.0701
91722001|NCT00207740|183336366|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.286
91722002|NCT00207740|183336366|SUPERIORITY_OR_OTHER|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
91722003|NCT00207740|183336366|SUPERIORITY_OR_OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
91722004|NCT00207740|183336366|SUPERIORITY_OR_OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
91722005|NCT00207740|183336367|SUPERIORITY_OR_OTHER|||||||0.718||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|Cochran-Mantel-Haenszel|||The null hypothesis was that the number of severe exacerbations per patient from baseline through week 24 for placebo is the same as that in the combined 100 mg and 200 mg golimumab. Assuming 1 severe exacerbation over 6 months per patient in the placebo group, there is 79% power to detect a 35% reduction in the combined 100 mg and 200 mg golimumab group at a 0.05 significance level.||||0.718
91722006|NCT00207740|183336367|SUPERIORITY_OR_OTHER|||||||0.779||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.779
91489167|NCT04873700|182850879|SUPERIORITY||||||=|0.1383|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.1383
91489168|NCT04873700|182850879|SUPERIORITY||||||=|0.0478|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Perianal disease||||=0.0478
91489169|NCT04873700|182850879|SUPERIORITY||||||=|0.1454|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Ileal disease||||=0.1454
91489170|NCT04873700|182850879|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=1.0000
91489171|NCT04873700|182850879|SUPERIORITY||||||=|0.4992|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=0.4992
91527239|NCT02632786|182929857|SUPERIORITY||Slope|-71.97||||0.0729|TWO_SIDED|95.0|-150.72|6.79|||Mixed Models Analysis|||||6.79|-150.72|0.0729
91527240|NCT02632786|182929858|SUPERIORITY|||||||0.4142|||||||Cochran-Mantel-Haenszel|||||||0.4142
91722007|NCT00207740|183336367|SUPERIORITY_OR_OTHER|||||||0.649||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.649
91722008|NCT00207740|183336367|SUPERIORITY_OR_OTHER|||||||0.256||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.256
91722009|NCT00207740|183336368|SUPERIORITY_OR_OTHER|||||||0.894|||||||Kruskal-Wallis|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.894
91722010|NCT00207740|183336368|SUPERIORITY_OR_OTHER|||||||0.572|||||||Kruskal-Wallis|||||||0.572
91722011|NCT00207740|183336368|SUPERIORITY_OR_OTHER|||||||0.731|||||||Kruskal-Wallis|||||||0.731
91722012|NCT00207740|183336368|SUPERIORITY_OR_OTHER|||||||0.856|||||||Kruskal-Wallis|||||||0.856
91722013|NCT00207740|183336369|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.273
91722014|NCT00207740|183336369|SUPERIORITY_OR_OTHER|||||||0.382|||||||Cochran-Mantel-Haenszel|||||||0.382
91489172|NCT04873700|182850879|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Episcleritis||||=1.0000
91489173|NCT04873700|182850879|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Uveitis||||=1.0000
91489174|NCT04873700|182850879|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
91722015|NCT00207740|183336369|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.350
91722016|NCT00207740|183336369|SUPERIORITY_OR_OTHER|||||||0.341|||||||Cochran-Mantel-Haenszel|||||||0.341
91722017|NCT00207740|183336370|SUPERIORITY_OR_OTHER|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.986
91722018|NCT00207740|183336370|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
91722019|NCT00207740|183336370|SUPERIORITY_OR_OTHER|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||||||0.858
91722020|NCT00207740|183336370|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91722021|NCT00207740|183336371|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||ANOVA|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.833
91722022|NCT00207740|183336371|SUPERIORITY_OR_OTHER|||||||0.814||95.0|||||ANOVA|||||||0.814
91722023|NCT00207740|183336371|SUPERIORITY_OR_OTHER|||||||0.897||95.0|||||ANOVA|||||||0.897
91722024|NCT00207740|183336371|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||ANOVA|||||||0.726
91722025|NCT05473039|183336380|SUPERIORITY|||||||0.2629|||||||Wilcoxon (Mann-Whitney)|||||||0.2629
91722026|NCT05473039|183336381|SUPERIORITY|||||||0.3582|||||||Wilcoxon (Mann-Whitney)|||||||0.3582
91722027|NCT05473039|183336382|SUPERIORITY|||||||0.2187|||||||Wilcoxon (Mann-Whitney)|||||||0.2187
91722028|NCT05473039|183336383|SUPERIORITY|||||||0.3005|||||||Wilcoxon (Mann-Whitney)|||||||0.3005
91722029|NCT05473039|183336384|SUPERIORITY|||||||0.0314|||||||Wilcoxon (Mann-Whitney)|||||||0.0314
91722030|NCT05473039|183336385|SUPERIORITY|||||||0.9214|||||||t-test, 2 sided|||||||0.9214
91722031|NCT05473039|183336385|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||0.042
91722032|NCT05473039|183336385|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||<0.001
91722033|NCT05473039|183336386|SUPERIORITY|||||||0.59695|||||||t-test, 2 sided|||||||0.59695
91722034|NCT05473039|183336386|SUPERIORITY|||||||0.466503|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.466503
91489175|NCT04873700|182850879|SUPERIORITY||||||=|0.2022|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.2022
91489176|NCT04873700|182850879|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
91489177|NCT04873700|182850879|SUPERIORITY||||||=|0|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.0000
91489178|NCT04873700|182850880|SUPERIORITY||||||=|0.2896|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.2896
91489179|NCT04873700|182850880|SUPERIORITY||||||=|0.0006|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.0006
91722035|NCT05473039|183336386|SUPERIORITY|||||||0.959877|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.959877
91722036|NCT05473039|183336387|SUPERIORITY|||||||0.06281|||||||t-test, 2 sided|||||||0.062810
91722037|NCT05473039|183336387|SUPERIORITY|||||||0.417757|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.417757
91722038|NCT05473039|183336387|SUPERIORITY|||||||0.968525|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.968525
91722039|NCT05473039|183336388|SUPERIORITY|||||||0.686488|||||||t-test, 2 sided|||||||0.686488
91722040|NCT05473039|183336388|SUPERIORITY|||||||0.39512|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.395120
91722041|NCT05473039|183336388|SUPERIORITY|||||||0.127135|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.127135
91722042|NCT05473039|183336389|SUPERIORITY|||||||0.257496|||||||t-test, 2 sided|||||||0.257496
91722043|NCT05850494|183336395|NON_INFERIORITY|Non-inferiority margin of -0.200 L at a one-sided significance level of 0.025.|Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.0136|||TWO_SIDED|95.0|-0.037|0.018||P-Value not applicable since a non-inferiority test was used for the analysis.|Mixed Models Analysis|||||0.018|-0.037|
91722044|NCT03806296|183336398|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.018|TWO_SIDED|95.0|-0.77|-0.07|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||-0.07|-0.77|0.018
91722045|NCT03806296|183336398|SUPERIORITY||Time X Group interaction|0.67||||0.001|TWO_SIDED|95.0|0.28|1.07|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||1.07|0.28|0.001
91722046|NCT03806296|183336399|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.61|1.59|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||1.59|0.61|<0.001
91722047|NCT03806296|183336399|SUPERIORITY||Time X Group interaction|-0.76|||<|0.001|TWO_SIDED|95.0|-1.09|-0.43|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||-0.43|-1.09|<0.001
91722048|NCT03806296|183336400|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.365|TWO_SIDED|95.0|-0.64|0.24|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.24|-0.64|0.365
91722049|NCT03806296|183336400|SUPERIORITY||Time X Group interaction|-0.43||||0.067|TWO_SIDED|95.0|-0.88|0.03|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||0.03|-0.88|0.067
91722050|NCT03806296|183336401|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.234|TWO_SIDED|95.0|-2.18|8.82|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||8.82|-2.18|0.234
91722051|NCT03806296|183336401|SUPERIORITY||Time X Group interaction|-6.15||||0.018|TWO_SIDED|95.0|-11.25|-1.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||-1.06|-11.25|0.018
91722052|NCT03806296|183336402|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.024|TWO_SIDED|95.0|0.07|0.94|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.94|0.07|0.024
91722053|NCT03806296|183336402|SUPERIORITY||Time X Group interaction|-0.1||||0.66|TWO_SIDED|95.0|-0.55|0.35|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.35|-0.55|0.660
91722054|NCT03806296|183336403|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.592|TWO_SIDED|95.0|-0.03|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.03|0.592
91489180|NCT04873700|182850880|SUPERIORITY||||||=|0.089|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=0.0890
91722055|NCT03806296|183336403|SUPERIORITY||Time X Group interaction|-0.03||||0.55|TWO_SIDED|95.0|-0.11|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.11|0.550
91722056|NCT03806296|183336404|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.55|TWO_SIDED|95.0|-0.07|0.04|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.04|-0.07|0.550
91722057|NCT03806296|183336404|SUPERIORITY||Time X Group interaction|-0.02||||0.556|TWO_SIDED|95.0|-0.1|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.10|0.556
91722058|NCT03806296|183336405|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.124|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.01|0.124
91722059|NCT03806296|183336405|SUPERIORITY||Time X Group interaction|0.0||||0.925|TWO_SIDED|95.0|-0.05|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.05|0.925
91722060|NCT03806296|183336406|SUPERIORITY||Risk Ratio (RR)|0.752||||0.42|TWO_SIDED|95.0|0.374|1.513|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (lower RR indicates less likelihood of cannabis use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary cannabis use outcome (yes/no in the past 3 months), accounting for age and sex.||1.513|0.374|0.42
91722061|NCT03806296|183336407|SUPERIORITY||Risk Ratio (RR)|1.236||||0.461|TWO_SIDED|95.0|0.704|2.171|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (higher RR indicates higher likelihood of alcohol use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary alcohol use outcome (yes/no in the past 3 months), accounting for age and sex.||2.171|0.704|0.461
91489181|NCT04873700|182850880|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Pyoderma gangrenosum||||=1.0000
91722062|NCT03806296|183336407|SUPERIORITY||Incident Rate Ratio|3.29||||0.007|TWO_SIDED|95.0|1.36|7.9|||negative binomial glm||Early/Middle Sleep group was the reference group (higher IRR indicates greater days of alcohol use in the Late Sleep group than in the Early/Middle Sleep group).|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a negative binomial GLM to test the effect of group (Early/Mid vs Late) on days of alcohol use, accounting for age and sex.||7.90|1.36|0.007
91722063|NCT03116230|183336427|OTHER|||||||0.005|||||||t-test, 2 sided|Treatment A vs Control||||||0.005
91722064|NCT03116230|183336427|OTHER|||||||0.64|||||||t-test, 2 sided|Treatment B vs Control||||||0.64
91722065|NCT02763566|183336431|SUPERIORITY||Hazard Ratio (HR)|0.499||||0.0001|TWO_SIDED|95.0|0.346|0.719|||Log Rank|||||0.719|0.346|0.0001
91722066|NCT02763566|183336432|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.24|0.588|||Log Rank|||||0.588|0.240|<0.0001
91722067|NCT02763566|183336434|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91722068|NCT02763566|183336434|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91722069|NCT02763566|183336436|SUPERIORITY|||||||0.0456|||||||Cochran-Mantel-Haenszel|||||||0.0456
91722070|NCT02763566|183336436|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
91722071|NCT02763566|183336437|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
91722072|NCT02763566|183336437|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91722073|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.77||0.287|TWO_SIDED|95.0|-5.36|1.59|||Mixed Models Analysis|||Global Health Status||1.59|-5.36|0.287
91722074|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.46||0.597|TWO_SIDED|95.0|-3.64|2.1|||Mixed Models Analysis|||Functional Scales - Physical functioning||2.10|-3.64|0.597
91489182|NCT04873700|182850880|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=1.0000
91489183|NCT04873700|182850880|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Primary sclerosing cholangitis||||=1.0000
91489184|NCT04873700|182850880|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
91722075|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|2.15||0.885|TWO_SIDED|95.0|-4.55|3.93|||Mixed Models Analysis|||Functional Scales - Role Functioning||3.93|-4.55|0.885
91722076|NCT02763566|183336438|SUPERIORITY||LSMean Difference|1.67|STANDARD_ERROR_OF_MEAN|1.74||0.34|TWO_SIDED|95.0|-1.77|5.1|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||5.10|-1.77|0.340
91722077|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-2.17|STANDARD_ERROR_OF_MEAN|1.62||0.182|TWO_SIDED|95.0|-5.37|1.03|||Mixed Models Analysis|||Functional Scales - Cognitive Functioning||1.03|-5.37|0.182
91722078|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-0.88|STANDARD_ERROR_OF_MEAN|2.12||0.678|TWO_SIDED|95.0|-5.05|3.29|||Mixed Models Analysis|||||3.29|-5.05|0.678
91722079|NCT02763566|183336438|SUPERIORITY||LSMean Difference|1.57|STANDARD_ERROR_OF_MEAN|1.7||0.355|TWO_SIDED|95.0|-1.77|4.91|||Mixed Models Analysis|||Symptom Scales - Fatigue||4.91|-1.77|0.355
91722080|NCT02763566|183336438|SUPERIORITY||LSMean Difference|0.95|STANDARD_ERROR_OF_MEAN|1.06||0.372|TWO_SIDED|95.0|-1.14|3.03|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||3.03|-1.14|0.372
91722081|NCT02763566|183336438|SUPERIORITY||LSMean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.63||0.74|TWO_SIDED|95.0|-3.75|2.66|||Mixed Models Analysis|||Symptom Scales - Pain||2.66|-3.75|0.740
91722082|NCT02763566|183336438|SUPERIORITY||LSMean Difference|2.16|STANDARD_ERROR_OF_MEAN|1.84||0.24|TWO_SIDED|95.0|-1.46|5.78|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||5.78|-1.46|0.240
91722083|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-0.81|STANDARD_ERROR_OF_MEAN|1.92||0.673|TWO_SIDED|95.0|-4.6|2.97|||Mixed Models Analysis|||Symptom scales - Insomnia||2.97|-4.60|0.673
91722084|NCT02763566|183336438|SUPERIORITY||LSMean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.74||0.001|TWO_SIDED|95.0|2.23|9.07|||Mixed Models Analysis|||Symptom Scales - Appetite||9.07|2.23|0.001
91722085|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.76||0.375|TWO_SIDED|95.0|-5.04|1.91|||Mixed Models Analysis|||Symptom Scales - Constipation||1.91|-5.04|0.375
91722086|NCT02763566|183336438|SUPERIORITY||LSMean Difference|15.82|STANDARD_ERROR_OF_MEAN|1.53||0|TWO_SIDED|95.0|12.81|18.84|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||18.84|12.81|0.000
91722087|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.97||0.557|TWO_SIDED|95.0|-7.59|4.1|||Mixed Models Analysis|||Symptom Scales - Financial Difficulties||4.10|-7.59|0.557
91722088|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|2.51||0.169|TWO_SIDED|95.0|-8.43|1.49|||Mixed Models Analysis|||Global Health Status||1.49|-8.43|0.169
91489185|NCT04873700|182850880|SUPERIORITY||||||=|0.0752|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.0752
91489186|NCT04873700|182850880|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
91489187|NCT04873700|182850880|SUPERIORITY||||||=|0.1032|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.1032
91489188|NCT00788073|182850904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.05|||||||ANCOVA|||||||0.05
91722089|NCT02763566|183336438|SUPERIORITY||LSMean Difference|1.58|STANDARD_ERROR_OF_MEAN|1.87||0.4|TWO_SIDED|95.0|-2.12|5.29|||Mixed Models Analysis|||Functional Scales - Physical Functioning||5.29|-2.12|0.400
91722090|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-1.72|STANDARD_ERROR_OF_MEAN|2.38||0.472|TWO_SIDED|95.0|-6.42|2.99|||Mixed Models Analysis|||Functional Scales - Role functioning||2.99|-6.42|0.472
91722091|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|0.31||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||2.28|-7.12|0.310
91722092|NCT02763566|183336438|SUPERIORITY||LSMean Difference|0.64|STANDARD_ERROR_OF_MEAN|2.98||0.83|TWO_SIDED|95.0|-5.26|6.55|||Mixed Models Analysis|||Functional Scales - Social Functioning||6.55|-5.26|0.830
91722093|NCT02763566|183336438|SUPERIORITY||LSMean Difference|2.73|STANDARD_ERROR_OF_MEAN|2.52||0.281|TWO_SIDED|95.0|-2.26|7.72|||Mixed Models Analysis|||Symptom Scales - Fatigue||7.72|-2.26|0.281
91722094|NCT02763566|183336438|SUPERIORITY||LSMean Difference|2.59|STANDARD_ERROR_OF_MEAN|1.99||0.194|TWO_SIDED|95.0|-1.33|6.52|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||6.52|-1.33|0.194
91722095|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-2.66|STANDARD_ERROR_OF_MEAN|2.42||0.275|TWO_SIDED|95.0|-7.45|2.14|||Mixed Models Analysis|||Symptom Scales - Pain||2.14|-7.45|0.275
91722096|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-2.49|STANDARD_ERROR_OF_MEAN|4.39||0.28|TWO_SIDED|95.0|-7.04|2.06|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||2.06|-7.04|0.280
91722097|NCT02763566|183336438|SUPERIORITY||LSMean Difference|1.97|STANDARD_ERROR_OF_MEAN|2.9||0.499|TWO_SIDED|95.0|-3.78|7.72|||Mixed Models Analysis|||Symptom Scales - Insomnia||7.72|-3.78|0.499
91722098|NCT02763566|183336438|SUPERIORITY||LSMean Difference|7.46|STANDARD_ERROR_OF_MEAN|2.92||0.012|TWO_SIDED|95.0|1.68|13.23|||Mixed Models Analysis|||Symptom Scales - Appetite||13.23|1.68|0.012
91722099|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-2.28|STANDARD_ERROR_OF_MEAN|2.29||0.321|TWO_SIDED|95.0|-6.83|2.27|||Mixed Models Analysis|||Symptom Scales - Constipation||2.27|-6.83|0.321
91722100|NCT02763566|183336438|SUPERIORITY||LSMean Difference|17.83|STANDARD_ERROR_OF_MEAN|2.32||0|TWO_SIDED|95.0|13.25|22.41|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||22.41|13.25|0.000
91527241|NCT02674490|182929874|SUPERIORITY|||||||0.54||||||Threshold for significance is two-sided alpha of 0.05.|Regression, Linear|The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age.||Sample Size Determination If sample size in each group is 20, we will have 89% power to detect a difference in means of 23 (the difference between A-tDCS mean change in accuracy of 33 and a sham mean change in accuracy of 10) assuming that the SD of change for both groups is 22.2 using a two group t-test with a two-sided alpha of 0.05.||||0.54
91722101|NCT02763566|183336438|SUPERIORITY||LSMean Difference|2.99|STANDARD_ERROR_OF_MEAN|3.14||0.342|TWO_SIDED|95.0|-3.21|9.19|||Mixed Models Analysis|||Symptom Scales - Financial DIfficulties||9.19|-3.21|0.342
91722102|NCT02763566|183336438|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.38||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Cognitive functioning||2.28|-7.12|0.310
91722103|NCT04896385|183336441|OTHER|||||||0.004|||||||repeated measures correlation|||F-VASI||||0.004
91722104|NCT04896385|183336441|OTHER|||||||0.41|||||||repeated measures correlation|||F-VASI||||0.41
91722105|NCT04896385|183336441|OTHER|||||||0.0002|||||||repeated measures correlation|||T-VASI||||0.0002
91722106|NCT04896385|183336441|OTHER|||||||0.91|||||||repeated measures correlation|||T-VASI||||0.91
91722107|NCT05233761|183336446|SUPERIORITY|The mean nightly difference in SWS + REM sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.6||0.035|TWO_SIDED|95.0|0.1|2.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.5|0.1|0.0350
91722108|NCT05233761|183336447|SUPERIORITY|The mean nightly difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0019|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.6|0.4|0.0019
91722109|NCT05233761|183336447|SUPERIORITY|The mean nightly difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.52|TWO_SIDED|95.0|-0.6|1.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.2|-.6|0.52
91722110|NCT05233761|183336447|SUPERIORITY|The mean nightly difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.8|-0.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||-0.5|-2.8|0.0040
91722111|NCT05233761|183336447|SUPERIORITY|The mean nightly difference in Awake Time (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.24|TWO_SIDED|95.0|-0.5|2.0|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.0|-.5|0.24
91722112|NCT05233761|183336448|SUPERIORITY|The mean nightly difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|2.6||0.0117|TWO_SIDED|95.0|1.7|13.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||13.3|1.7|0.0117
91722113|NCT05233761|183336448|SUPERIORITY|The mean nightly difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.3||0.0126|TWO_SIDED|95.0|0.7|5.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.9|0.7|0.0126
91722114|NCT05233761|183336448|SUPERIORITY|The mean nightly difference in REM sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.0||0.51|TWO_SIDED|95.0|-2.7|5.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.3|-2.7|0.51
91722115|NCT05233761|183336448|SUPERIORITY|The mean nightly difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.6||0.0574|TWO_SIDED|95.0|-13.7|0.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||0.2|-13.7|0.0574
91722116|NCT05233761|183336448|SUPERIORITY|The mean nightly difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|2.4||0.3|TWO_SIDED|95.0|-2.4|6.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||6.9|-2.4|0.3
91722117|NCT05233761|183336448|SUPERIORITY|The mean nightly difference in Total Sleep Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|4.7||0.14|TWO_SIDED|95.0|-16.1|2.4|||t-test, 2 sided|||The null hypothesis was that there was no difference in Total Sleep Time (min) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.4|-16.1|0.14
91722118|NCT05233761|183336449|SUPERIORITY|"The mean nightly difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.53|TWO_SIDED|95.0|-0.7|1.3|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.3|-.7|0.53
91722119|NCT05233761|183336449|SUPERIORITY|"The mean nightly difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.32|TWO_SIDED|95.0|-0.6|1.7|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.7|-0.6|0.32
91722517|NCT02629159|183337893|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|34.1|||<|0.001|TWO_SIDED|95.0|29.0|39.2||This comparison was the primary analysis for US/FDA regulatory purposes, and a ranked key secondary endpoint for EU/EMA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||39.2|29.0|<0.001
91489189|NCT00788073|182850905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.008||95.0|||||ANCOVA|||||||0.008
91489190|NCT00910273|182850908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.608|TWO_SIDED|95.0|-5.14|8.58|||Mixed Models Analysis|||"Null Hypothesis: No difference in Change in FMD at 12 weeks for Etanercept and placebo.~Alternative Hypothesis: Difference in Change in FMD at 12 weeks for Etanercept and placebo.~Sample size of 36 subjects per treatment arm was planned based on an expected difference of 0.9 in FMD (Standard Deviation \[SD\] 1.5), with 80% power and 5% significance level."||8.58|-5.14|0.608
91489191|NCT00910273|182850909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.82||||0.476|TWO_SIDED|95.0|-3.35|7.0|||Mixed Models Analysis||Analyses available for Week 4 only, due to limited number of participants for Week 24 to Week 52.|Week 4||7.00|-3.35|0.476
91691110|NCT04886596|183275527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
91691111|NCT04886596|183275527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|59.16|||||TWO_SIDED|95.0|-119.6|95.93|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.||95.93|-119.60|
91691112|NCT04886596|183275527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
91691113|NCT04886596|183275527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
91691114|NCT04886596|183275527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|20.27|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|20.27|
91691115|NCT04886596|183275528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|51.13|||||TWO_SIDED|95.0|40.31|60.21|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||60.21|40.31|
91691116|NCT04886596|183275528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.44|||||TWO_SIDED|95.0|48.1|66.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||66.96|48.10|
91691117|NCT04886596|183275529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.33|||||TWO_SIDED|95.0|-1.47|5.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||5.99|-1.47|
91722518|NCT02629159|183337893|SUPERIORITY||Response Rate Difference|7.5||||0.018|TWO_SIDED|95.0|1.2|13.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||13.8|1.2|0.018
91722120|NCT05233761|183336449|SUPERIORITY|"The mean nightly difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2|TWO_SIDED|95.0|-0.4|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.4|0.20
91722121|NCT05233761|183336449|SUPERIORITY|"The mean nightly difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.45|TWO_SIDED|95.0|-0.7|1.6|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.6|-0.7|0.45
91722122|NCT05233761|183336449|SUPERIORITY|"The mean nightly difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4|TWO_SIDED|95.0|-0.8|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.8|0.4
91489192|NCT00910273|182850910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.65|TWO_SIDED|95.0|-0.08|0.13|||ANCOVA|||Week 12; Common Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.13|-0.08|0.650
91722123|NCT05252702|183336464|SUPERIORITY|"The primary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFR ≤ 78% vs. H1: CFR \> 78%~where 78% was the performance goal (PG)."|binomial proportion|90.3|||<|0.0001|ONE_SIDED|97.5|87.0|||The CFR was estimated as a binomial proportion and a one-sided 97.5% lower confidence bound of the CFR was calculated using the normal approximation. The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was calculated and compared to the 0.025 significance level.|||||87|<0.0001
91722124|NCT05252702|183336465|SUPERIORITY|"The primary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFR ≤ 76.5% vs. H1: CFR \> 76.5%~where 76.5% is the performance goal. The CFR was estimated using a Kaplan-Meier survival analysis and the 97.5% lower confidence bound of CFR was calculated using the Greenwood variance estimates."|Kaplan-Meier|88.6|||<|0.0001|ONE_SIDED|97.5|84.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 76.5%.|one-sided Z-test|The p-value for the one-sided Z-test was calculated and compared to the 2.5% significance level.|||||84.5|<0.0001
91722125|NCT05252702|183336466|SUPERIORITY||binomial proportion|90.8|||<|0.0001|ONE_SIDED|97.5|87.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 82.5%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #1 hypothesis at 3 month was formally expressed as:~H0: Rate ≤ 82.5% vs. H1: Rate \> 82.5%~where 82.5% was the performance goal (PG)."|||87.5|<0.0001
91489193|NCT00910273|182850910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.513|TWO_SIDED|95.0|-0.13|0.07|||ANCOVA|||Week 12; Common Bulb; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.07|-0.13|0.513
91489194|NCT00910273|182850910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.592|TWO_SIDED|95.0|-0.14|0.08|||ANCOVA|||Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.08|-0.14|0.592
91489195|NCT00910273|182850915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.008|TWO_SIDED|95.0|-3.05|-0.5|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.50|-3.05|0.008
91489196|NCT00910273|182850915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.021|TWO_SIDED|95.0|-3.7|-0.33|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.33|-3.70|0.021
91489197|NCT00910273|182850923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.003|TWO_SIDED|95.0|-1.74|-0.4|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.40|-1.74|0.003
91489198|NCT00910273|182850923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.029|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.10|-1.72|0.029
91489199|NCT00910273|182850929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.041|TWO_SIDED|95.0|-2.13|-0.05|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.05|-2.13|0.041
91489200|NCT00910273|182850929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|95.0|-2.55|-0.01|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.01|-2.55|0.048
91489201|NCT00910273|182850930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.575|TWO_SIDED|95.0|-0.89|1.57|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||1.57|-0.89|0.575
91489202|NCT00910273|182850930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.204|TWO_SIDED|95.0|-0.52|2.3|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||2.30|-0.52|0.204
91722126|NCT05252702|183336467|SUPERIORITY||binomial proportion|92.8|||<|0.0001|ONE_SIDED|97.5|89.7|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 80%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The Rate at 12 months was estimated as a binomial proportion and the one-sided 97.5% LCB of the Rate was calculated using the normal approximation.|"The primary effectiveness endpoint #1 hypothesis at 12 months was formally expressed as:~H0: Rate ≤ 80% vs. H1: Rate \> 80%~where 80% was the performance goal (PG)."|||89.7|<0.0001
91722127|NCT05252702|183336468|SUPERIORITY||binomial proportion|98.2|||<|0.0001|ONE_SIDED|97.5|96.6|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 83%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #2 hypothesis was formally expressed as:~H0: RateAV ≤ 83% vs. H1: RateAV \> 83%~where 83% is the performance goal."|||96.6|<0.0001
91722128|NCT05252702|183336469|SUPERIORITY||binomial proportion|91.3||||0.0003|ONE_SIDED|97.5|88.1|||The null hypothesis was to be rejected at the 2.5% significance level if the lower confidence bound exceeded the Performance Goal (PG) of 84%.|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was to be calculated and compared to the 0.025 significance level.||"The secondary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFRA ≤ 84% vs. H1: CFRA \> 84%~where 84% was the performance goal."|||88.1|0.0003
91722129|NCT05252702|183336470|SUPERIORITY||Kaplan-Meier|91.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|ONE_SIDED|97.5|87.1|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 82%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The 97.5% lower confidence bound (LCB) of CFRA was calculated using the Greenwood variance estimates.|"The secondary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFRA ≤ 82% vs. H1: CFRA \> 82%~where 82% is the performance goal."|||87.1|<0.0001
91722130|NCT05252702|183336471|OTHER||mixed effects model for repeated measure|0.91|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.78|1.04|||t-test, 1 sided|Two one-sided t-tests (TOST), with an alpha level of 0.025, and n-1 degrees of freedom.||"An analysis of these data provided an estimate of the 95% confidence interval for the mean slope across analyzable subjects, which had a pre-specified success criterion requiring that this confidence interval must fall between slopes of 65% and 135%. The following hypothesis was evaluated:~H0: Mean Slope \< 0.65 or Mean Slope \> 1.35~H1: 0.65 ≤ Mean Slope ≤ 1.35"||1.04|0.78|<0.001
91722131|NCT01192178|183336486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.928|TWO_SIDED|95.0|0.519|1.819||Cox Proportional Hazards model adjusted for investigative center|Regression, Cox||The risk of having an asthma exacerbation during the treatment period was analyzed.|||1.819|0.519|0.928
91722132|NCT02164916|183336494|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.001|TWO_SIDED|95.0|0.31|0.75|||Log Rank|||||0.75|0.31|0.001
91722133|NCT00296517|183336501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.805||95.0|-1.6|2.0|||ANOVA|||Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.||2.0|-1.6|0.805
91722134|NCT00296517|183336511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Log Rank|||||||0.036
91722135|NCT01143324|183336530|SUPERIORITY_OR_OTHER||Mean|1.3|STANDARD_DEVIATION|0.5|||TWO_SIDED|95.0|1.2|1.3||||||||1.3|1.2|
91722136|NCT01143324|183336531|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.9|||t-test, 2 sided|||||-2.9|-3.6|<0.0001
91722137|NCT01143324|183336532|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.2|-3.3|||t-test, 2 sided|||||-3.3|-4.2|<0.0001
91489203|NCT03540030|182850931|OTHER|||||||0.297|||||||Wilcoxon (Mann-Whitney)|||||||.297
91489204|NCT03540030|182850932|OTHER|||||||0.005||||||At the 6 hour time point|Wilcoxon (Mann-Whitney)|||||||0.005
91489205|NCT03540030|182850932|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||At the 12 hour time point||||0.005
91489206|NCT03540030|182850933|OTHER|||||||0.0801|||||||Fisher Exact|||||||0.0801
91489207|NCT03540030|182850934|OTHER|||||||0.0154|||||||Chi-squared|||||||0.0154
91489208|NCT03540030|182850935|OTHER|||||||0.2139|||||||Fisher Exact|||||||0.2139
91489209|NCT03540030|182850937|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
91489210|NCT03540030|182850938|OTHER|||||||0.9669|||||||Wilcoxon (Mann-Whitney)|||||||0.9669
91489211|NCT03540030|182850939|OTHER|||||||0.9208|||||||Wilcoxon (Mann-Whitney)|||||||.9208
91489212|NCT03540030|182850940|OTHER|||||||0.6481|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.6481
91722138|NCT01143324|183336533|SUPERIORITY_OR_OTHER||Difference from pre-op mean|0.35|||<|0.0001|TWO_SIDED|95.0|0.3|0.41|||t-test, 2 sided|||||0.41|0.30|<0.0001
91722139|NCT01143324|183336535|SUPERIORITY_OR_OTHER||Percentage|27.0|||||||||||||61/226 patients underwent a rehabilitation programs between 6 and 12 months follow up visit, making it 27.0 % of the total.|||||
91722140|NCT01143324|183336536|SUPERIORITY_OR_OTHER||Percentage|1.2|||||||||||||The rate of additional lumbar spinal surgeries at treated level was 1.2% (3/252) patients.|||||
91722141|NCT01143324|183336537|SUPERIORITY_OR_OTHER||Percentage|1.6|||||||||||||The rate of additional lumbar spinal surgeries at the same level was 1.6% (4/252) patients.|||||
91722142|NCT01143324|183336538|SUPERIORITY_OR_OTHER||Percentage at 12 months|47.6||||||||||||||||||
91722143|NCT01143324|183336540|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-23.0|||<|0.0001|TWO_SIDED|95.0|-25.5|-20.5|||t-test, 2 sided|||||-20.5|-25.5|<0.0001
91722144|NCT01143324|183336541|SUPERIORITY_OR_OTHER||Percentage|42.7||||||||||||||||||
91722145|NCT01143324|183336542|SUPERIORITY_OR_OTHER||Mean|3.2|STANDARD_DEVIATION|2.0||||95.0|2.9|3.4||||||||3.4|2.9|
91722146|NCT00846365|183336558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and Baseline as a covariate.||-3.8|-8.4|<0.001
91722147|NCT00846365|183336558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.1|-4.4||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.4|-9.1|<0.001
91722148|NCT00846365|183336559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.5|-3.7||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-3.7|-8.5|<0.001
91722149|NCT00846365|183336559|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.6|-4.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.8|-9.6|<0.001
91722150|NCT00846365|183336563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-7.5|-3.7||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-3.7|-7.5|<0.001
91722151|NCT00846365|183336563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.1|-5.2||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-5.2|-9.1|<0.001
91722519|NCT02629159|183337894|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|18.6|26.5||This comparison was the primary analysis for EU/EMA regulatory purposes, and a ranked key secondary endpoint for US/FDA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||26.5|18.6|<0.001
91722520|NCT02629159|183337894|SUPERIORITY||Response Rate Difference|10.7|||<|0.001|TWO_SIDED|95.0|5.3|16.1||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.1|5.3|<0.001
91722521|NCT02629159|183337895|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-1.33|||<|0.001|TWO_SIDED|95.0|-1.469|-1.194||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use, and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.194|-1.469|<0.001
91489213|NCT03540030|182850940|OTHER|||||||0.3911|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.3911
91489214|NCT03540030|182850941|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
91722522|NCT02629159|183337895|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.638|-0.295||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.295|-0.638|<0.001
91722523|NCT02629159|183337896|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.97|-0.37||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.37|-0.97|<0.001
91489215|NCT03540030|182850942|OTHER|||||||0.3177|||||||Fisher Exact|||||||0.3177
91489216|NCT03540030|182850943|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
91489217|NCT03540030|182850944|OTHER|||||||0.2349|||||||Fisher Exact|||||||0.2349
91489218|NCT03540030|182850945|OTHER|||||||0.7892|||||||Wilcoxon (Mann-Whitney)|||||||0.7892
91489219|NCT03540030|182850946|OTHER|||||||0.2023|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.2023
91489220|NCT03540030|182850946|OTHER|||||||0.2486|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.2486
91489221|NCT00569270|182850947|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||a priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FEV1 of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.027
91489222|NCT00569270|182850948|SUPERIORITY_OR_OTHER||Spearman rho|0.19||||0.96||95.0||||A priori threshold for statistical significance: p=0.05|Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measure includes change in FEV1 post tiotropium||||0.96
91527242|NCT03154359|182929888|OTHER|||||||0.197|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.197
91527243|NCT03154359|182929888|OTHER|||||||0.562|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.562
91722524|NCT02629159|183337896|SUPERIORITY||LS Mean Difference|0.14||||0.448|TWO_SIDED|95.0|-0.23|0.51||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||0.51|-0.23|0.448
91722152|NCT00764517|183336630|OTHER||Hazard Ratio (HR)|0.33||||0.002|TWO_SIDED|95.0|0.16|0.69|||Log Rank|||||0.69|0.16|0.002
91722153|NCT00764517|183336631|OTHER||Hazard Ratio (HR)|0.42||||0.011|TWO_SIDED|95.0|0.21|0.84|||Log Rank|||||0.84|0.21|0.011
91722154|NCT00460798|183336634|SUPERIORITY_OR_OTHER||Obective Response Rate (Percent)|40.6|||||TWO_SIDED|95.0|35.5|46.0|||||Exact method based on binomial distribution|Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR||46.0|35.5|
91722155|NCT01953237|183336647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|||||||Mixed Models Analysis|||||||0.5580
91722156|NCT01186770|183336652|SUPERIORITY||Least square (LS) mean difference|2.83||||0.1692||95.0|-1.21|6.86||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with treatment as effect and analysis region as covariate.||6.86|-1.21|0.1692
91722157|NCT01186770|183336652|SUPERIORITY||LS mean difference|6.51||||0.0016|TWO_SIDED|95.0|2.47|10.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||10.55|2.47|0.0016
91722158|NCT01186770|183336652|SUPERIORITY||LS mean difference|9.13|||<|0.0001|TWO_SIDED|95.0|5.09|13.18||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||13.18|5.09|< 0.0001
91722159|NCT01186770|183336653|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3076|TWO_SIDED|95.0|0.82|1.84||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||1.84|0.82|0.3076
91722160|NCT01186770|183336653|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0339|TWO_SIDED|95.0|1.03|2.29||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.29|1.03|0.0339
91722161|NCT01186770|183336653|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0043||95.0|1.2|2.66||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.66|1.20|0.0043
91722162|NCT01186770|183336654|SUPERIORITY||LS mean difference|0.09||||0.692|TWO_SIDED|95.0|-0.36|0.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.55|-0.36|0.6920
91489223|NCT00569270|182850949|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FRC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.318
91722163|NCT01186770|183336654|SUPERIORITY||LS mean difference|0.51||||0.0274|TWO_SIDED|95.0|0.06|0.97||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.97|0.06|0.0274
91722164|NCT01186770|183336654|SUPERIORITY||LS mean difference|0.53||||0.0237|TWO_SIDED|95.0|0.07|0.98||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.98|0.07|0.0237
91722165|NCT01995201|183336671|OTHER|||||||0.5231|||||||Chi-squared|||||||0.5231
91489224|NCT00569270|182850950|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was p \< 0.05|Mixed Models Analysis|||Mean difference of Peak FVC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.078
91722166|NCT01138735|183336714|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics||"null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%"||||<0.001
91722167|NCT01138735|183336715|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|ANCOVA|normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.||null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)||||<0.001
91722168|NCT01138735|183336716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center||||||<0.001
91722169|NCT01138735|183336717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment||||||<0.001
91691118|NCT04886596|183275529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.32|||||TWO_SIDED|95.0|-0.5|6.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||6.98|-0.50|
91722170|NCT06001866|183336718|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
91722171|NCT06001866|183336718|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91722172|NCT06001866|183336719|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91722173|NCT06001866|183336719|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91722174|NCT06001866|183336720|SUPERIORITY||||||=|0.78|||||||LSD test|||||||=0.78
91722175|NCT06001866|183336720|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<.00001
91722176|NCT06001866|183336721|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
91722177|NCT06001866|183336721|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91722178|NCT06001866|183336722|SUPERIORITY||||||=|0.75|||||||LSD test|||||||=0.75
91722179|NCT06001866|183336722|SUPERIORITY||||||<|0.01|||||||LSD test|||||||<0.01
91489225|NCT00569270|182850951|SUPERIORITY_OR_OTHER||Spearman rho|-0.26||||0.4||95.0|||||Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (19 patients); measures include change in IC at trough tiotropium.||||0.4
91691119|NCT04886596|183275529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.68|||||TWO_SIDED|95.0|-1.55|8.63|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||8.63|-1.55|
91722180|NCT06001866|183336723|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
91722181|NCT06001866|183336723|SUPERIORITY||||||=|0.62|||||||LSD test|||||||=0.62
91722182|NCT06001866|183336724|SUPERIORITY||||||=|0.16|||||||LSD test|||||||=0.16
91722183|NCT06001866|183336724|SUPERIORITY||||||=|0.33|||||||LSD test|||||||=0.33
91722184|NCT06001866|183336725|SUPERIORITY||||||=|0.54|||||||t-test, 2 sided|||||||=.54
91722185|NCT06001866|183336726|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91722186|NCT04725188|183336750|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.091|TWO_SIDED|95.0|0.53|1.13|||Regression, Cox|||||1.13|0.53|0.0910
91722187|NCT04725188|183336750|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.9622|TWO_SIDED|95.0|0.96|2.02|||Regression, Cox|||||2.02|0.96|0.9622
91722188|NCT04725188|183336751|SUPERIORITY||Difference in percentage|14.7||||0.0113|TWO_SIDED|95.0|2.1|26.9|||Miettinen & Nurminen method|||||26.9|2.1|0.0113
91722189|NCT04725188|183336751|SUPERIORITY||Difference in percentage|-9.4||||0.975|TWO_SIDED|95.0|-19.6|0.0|||Miettinen & Nurminen method|||||0.0|-19.6|0.9750
91722190|NCT04725188|183336752|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0943|TWO_SIDED|95.0|0.5|1.15|||Regression, Cox|||||1.15|0.50|0.0943
91722191|NCT04725188|183336752|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5974|TWO_SIDED|95.0|0.7|1.58|||Regression, Cox|||||1.58|0.70|0.5974
91722192|NCT04279483|183336805|SUPERIORITY|Linear mixed effects|Slope|-0.64|STANDARD_ERROR_OF_MEAN|1.95||0.74|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.74
91722193|NCT04279483|183336805|SUPERIORITY|Linear mixed effects|Slope|-0.84|STANDARD_ERROR_OF_MEAN|2.12||0.69|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.69
91722194|NCT04279483|183336806|SUPERIORITY|Linear mixed effects|Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.54||0.49|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that cigarettes smoked would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.49
91722195|NCT04279483|183336806|SUPERIORITY|Linear mixed effects|Slope|0.21|STANDARD_ERROR_OF_MEAN|0.59||0.72|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.72
91722196|NCT00876343|183336809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.006|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|||||-0.6|-3.7|0.006
91722197|NCT00876343|183336809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.5|||ANCOVA|||||-1.5|-4.6|<0.001
91691120|NCT04886596|183275529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.99|||||TWO_SIDED|95.0|1.81|11.9|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||11.90|1.81|
91722198|NCT04153864|183336846|NON_INFERIORITY|The Non-Inferiority Margin (NIM) was defined as 10% of the mean EPDS score in the Specialist group (8.91), which corresponded to a value of 0.89. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.86|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 10% non-inferiority margin (NIM).||0.86||<0.05
91722199|NCT04153864|183336846|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.92), which corresponded to a value of 1.16. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.23|||<|0.05|ONE_SIDED|95.0||0.77|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.77||<0.05
91722200|NCT04153864|183336846|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.81), which corresponded to a value of 1.15. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.91|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this is per protocol analysis. Due to institutional pandemic-related restrictions, 21 participants were switched from In-Person to Telemedicine and met criteria for the per protocol analyses.||0.91||<0.05
91691121|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
91691122|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
91691123|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
91691124|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
91691125|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
91489226|NCT00569270|182850952|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak IC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.067
91527244|NCT03154359|182929889|OTHER|||||||0.558|||||||t-test, 2 sided|||||||0.558
91527245|NCT03154359|182929890|OTHER|||||||0.147|||||||t-test, 2 sided|||||||0.147
91691126|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
91489227|NCT00569270|182850953|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||A priori threshold for statistical significance: p\<0.05|Regression, Logistic|||Mean difference of Peak FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.615
91691127|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
91691128|NCT04886596|183275530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
91691129|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.81|||||TWO_SIDED|95.0|-25.43|17.49|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||17.49|-25.43|
91691130|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-4.72|||||TWO_SIDED|95.0|-28.26|14.61|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||14.61|-28.26|
91691131|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.61|||||TWO_SIDED|95.0|-28.2|16.38|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine||16.38|-28.20|
91691132|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.59|||||TWO_SIDED|95.0|-27.55|15.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||15.98|-27.55|
91691133|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.98|||||TWO_SIDED|95.0|-23.52|23.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||23.99|-23.52|
91722201|NCT04153864|183336848|NON_INFERIORITY|The NIM was defined as 10% of the mean GAD-7 score for the Specialist group (6.36), which corresponded to a value of 0.64. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.08|||<|0.05|ONE_SIDED|95.0||0.57|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 10% non-inferiority margin (NIM).This analysis was performed on 3-months post-randomization scores.||0.57||<0.05
91489228|NCT00569270|182850954|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Statistical significance was p\<0.05|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.325
91691134|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.71|||||TWO_SIDED|95.0|-28.56|19.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||19.70|-28.56|
91691135|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.8|||||TWO_SIDED|95.0|-22.14|26.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||26.00|-22.14|
91691136|NCT04886596|183275531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.64|||||TWO_SIDED|95.0|-21.73|25.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||25.48|-21.73|
91691137|NCT04886596|183275532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.94|||||TWO_SIDED|95.0|28.91|82.15|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.15|28.91|
91691138|NCT04886596|183275532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.8|||||TWO_SIDED|95.0|28.5|83.2|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.20|28.50|
91691139|NCT04886596|183275532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.69|||||TWO_SIDED|95.0|28.56|85.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.47|28.56|
91691140|NCT04886596|183275532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|21.45|84.29|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.29|21.45|
91691141|NCT04886596|183275533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.59|||||TWO_SIDED|95.0|-8.29|12.42|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||12.42|-8.29|
91691142|NCT04886596|183275533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.7|||||TWO_SIDED|95.0|-4.05|16.39|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||16.39|-4.05|
91691143|NCT04886596|183275533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|10.95|||||TWO_SIDED|95.0|-0.68|21.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||21.31|-0.68|
91527246|NCT03154359|182929891|OTHER|||||||0.495|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.495
91527247|NCT03154359|182929891|OTHER|||||||0.955|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.955
91489229|NCT00569270|182850955|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.345
91489230|NCT00569270|182850956|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC(L) in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.068
91489231|NCT00569270|182850957|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of trough FVC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.589
91691144|NCT04886596|183275533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|12.12|||||TWO_SIDED|95.0|0.32|22.58|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||22.58|0.32|
91722202|NCT04153864|183336848|NON_INFERIORITY|The NIM was defined as 13% of the mean GAD-7 score in the In-Person group (6.29), which corresponded to a value of 0.82. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.14|||<|0.05|ONE_SIDED|95.0||0.73|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.73||<0.05
91722203|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|1.31|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
91722204|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|1.19|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
91691145|NCT02329015|183275615|SUPERIORITY_OR_OTHER||Slope|0.58||||0.54|TWO_SIDED|95.0|-1.25|2.41|||Regression, Logistic|||Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.||2.41|-1.25|0.54
91722205|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
91722206|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|1.15|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
91691146|NCT02329015|183275615|SUPERIORITY_OR_OTHER||Slope|1.67||||0.08|TWO_SIDED|95.0|-0.21|3.55|||Regression, Linear|||Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.||3.55|-0.21|0.08
91691147|NCT02329015|183275615|SUPERIORITY_OR_OTHER||Slope|2.7||||0.009|TWO_SIDED|95.0|0.69|4.71|||Regression, Linear|||Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.||4.71|0.69|0.009
91691148|NCT02329015|183275616|SUPERIORITY_OR_OTHER|||||||0.301|||||||Regression, Linear|||Analysis of the Voluntary subscale of the Response to Stress Questionnaire||||0.301
91527248|NCT03154359|182929892|OTHER|||||||0.991|||||||t-test, 2 sided|||||||0.991
91527249|NCT03154359|182929893|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
91527250|NCT03154359|182929894|OTHER|||||||0.456|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.456
91691149|NCT02348112|183275644|NON_INFERIORITY|The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.|Difference in Proportions|-0.054||||0.013|TWO_SIDED|95.0|-0.139|0.031|||Normal approximation test (Z-test)|||||0.031|-0.139|0.013
91691150|NCT02348112|183275645|NON_INFERIORITY|The number and proportion of subjects experiencing device- and/or procedure-related serious adverse events were tabulated for each study group. Non-inferiority through 36 months was calculated using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the lower limit of the 95% confidence interval for the difference in proportions (Comparator - Altis) is greater than -0.10 in the mITT analysis population.|Difference in Proportions|0.013|||<|0.0001|TWO_SIDED|95.0|-0.023|0.048|||Normal approximation test (Z-test)|||||0.048|-0.023|<0.0001
91722207|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|1.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
91722208|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
91722209|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
91722210|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
91722211|NCT06442800|183336850|SUPERIORITY||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
91527251|NCT03154359|182929894|OTHER|||||||0.822|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.822
91527252|NCT03154359|182929895|OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
91691151|NCT03714828|183275646|OTHER||Overall Response Rate|100.0||||0.0005|ONE_SIDED|95.0|76.2||||One-sample binomial test|One-sample binomial test versus null hypothesis value of 0.50.|||||76.2|0.0005
91691152|NCT03714828|183275648|OTHER|Descriptive statistics|Mean|48.7|STANDARD_DEVIATION|29.2|||TWO_SIDED|||||||||||||
91691153|NCT03714828|183275650|OTHER|Binomial proportion of TILs|Percentage|83.3|||||TWO_SIDED|||||||||||||
91722212|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
91722213|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
91489232|NCT00569270|182850958|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough IC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.922
91527253|NCT03154359|182929896|OTHER|||||||0.539|||||||t-test, 2 sided|||||||0.539
91691154|NCT03714828|183275653|OTHER|Counts of TILs|Percentage|100.0|||||TWO_SIDED|||||||||||||
91691155|NCT03714828|183275654|OTHER||Percentage|100.0|||||TWO_SIDED|||||||||||||
91691156|NCT01168427|183275656|OTHER|There was no formal statistical hypothesis tested. The goal was to estimate the procedure-related complications 90 days post implant using the Kaplan-Meier method.|Rate|0.034|||||ONE_SIDED|95.0||0.1292||||||||0.1292||
91691157|NCT01709500|183275729|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|95.0|-58.1|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the placebo group using an appropriate contrast statement.||-44.8|-58.1|<0.0001
91691158|NCT01709500|183275730|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.2|||<|0.0001|TWO_SIDED|95.0|-58.7|-45.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-45.6|-58.7|<0.0001
91691159|NCT01709500|183275731|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.7|-42.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.2|-54.7|<0.0001
91722214|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.54|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
91722215|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
91691160|NCT01709500|183275732|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-55.0|-42.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.5|-55|<0.0001
91691161|NCT01709500|183275733|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|||<|0.0001|TWO_SIDED|95.0|-44.1|-34.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-34.5|-44.1|<0.0001
91722216|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.66|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
91527254|NCT03154359|182929897|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.130
91527255|NCT03154359|182929898|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
91527256|NCT00569803|182929907|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.86|||||TWO_SIDED|90.0|0.68|1.08|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.08|0.68|
91691162|NCT01709500|183275734|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|95.0|-44.5|-35.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-35.1|-44.5|<0.0001
91691163|NCT01709500|183275735|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-51.8|-39.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-39.7|-51.8|<0.0001
91691164|NCT01709500|183275736|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.3|-40.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-40.4|-52.3|<0.0001
91691165|NCT01709500|183275737|SUPERIORITY_OR_OTHER||LS Mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-37.4|-28.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.1|-37.4|<0.0001
91691166|NCT01709500|183275738|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-39.2|-29.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-29.8|-39.2|<0.0001
91691167|NCT01709500|183275739|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-47.8|-36.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-36.2|-47.8|<0.0001
91691168|NCT01709500|183275740|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-34.5|-25.4|||Mixed Models Analysis|Threshold for significance ≤ 0.05.||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.4|-34.5|<0.0001
91691169|NCT01709500|183275741|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.8|||<|0.0001|TWO_SIDED|95.0|-66.8|-50.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-50.8|-66.8|<0.0001
91722217|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
91722218|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
91691170|NCT01709500|183275742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|52.2|||<|0.0001|TWO_SIDED|95.0|20.9|130.0||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||130|20.9|<0.0001
91691171|NCT01709500|183275743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|21.4|132.6||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||132.6|21.4|<0.0001
91691172|NCT01709500|183275744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|239.7|||<|0.0001|TWO_SIDED|95.0|31.6|1820.3||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1820.3|31.6|<0.0001
91691173|NCT01709500|183275745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.6|||<|0.0001|TWO_SIDED|95.0|31.4|1841.7||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1841.7|31.4|<0.0001
91691174|NCT01709500|183275746|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-20.3|||<|0.0001|TWO_SIDED|95.0|-26.4|-14.2||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.2|-26.4|<0.0001
91691175|NCT01709500|183275747|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8|||=|0.0009|TWO_SIDED|95.0|2.8|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||10.7|2.8|= 0.0009
91691176|NCT01709500|183275748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|||=|0.0012|TWO_SIDED|95.0|-17.5|-4.3||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.||-4.3|-17.5|= 0.0012
91691177|NCT01709500|183275749|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4|||=|0.0062|TWO_SIDED|95.0|1.3|7.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.5|1.3|= 0.0062
91691178|NCT01709500|183275750|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.0|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-13.1|-25|<0.0001
91691179|NCT01709500|183275751|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||=|0.0147|TWO_SIDED|95.0|0.9|7.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.8|0.9|= 0.0147
91691180|NCT01709500|183275752|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.6|||=|0.024|TWO_SIDED|95.0|-16.1|-1.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-1.1|-16.1|= 0.024
91691181|NCT01709500|183275753|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3|||=|0.1475|TWO_SIDED|95.0|-0.8|5.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.5|-0.8|= 0.1475
91691182|NCT00856492|183275800|SUPERIORITY_OR_OTHER|||||||0.019|||||||Chi-squared|||||||0.019
91691183|NCT00856492|183275801|SUPERIORITY_OR_OTHER|||||||0.64|||||||Log Rank|||||||0.64
91691184|NCT00856492|183275802|SUPERIORITY_OR_OTHER|||||||0.71|||||||Log Rank|||||||0.71
91691185|NCT01120184|183275838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (\<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.91||||0.3125|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3125
91691186|NCT01120184|183275838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was \<1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.87||||0.1407|TWO_SIDED|97.5|0.69|1.08||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.08|0.69|0.1407
91722219|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
91722220|NCT06442800|183336851|SUPERIORITY||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
91722221|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.38|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
91722222|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.34|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
91722223|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.4|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
91722224|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
91722225|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.37|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
91722226|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
91722227|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
91489233|NCT00569270|182850959|SUPERIORITY_OR_OTHER|||||||-0.02||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.02
91722228|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.04||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||0.02
91722229|NCT06442800|183336852|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
91722230|NCT04717557|183336861|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91489234|NCT00569270|182850960|SUPERIORITY_OR_OTHER|||||||-0.13||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough TLC (L) of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.13
91722231|NCT04717557|183336861|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722232|NCT04717557|183336862|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722233|NCT04717557|183336863|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722234|NCT04717557|183336864|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|t-test, 2 sided|||||||>0.5
91722235|NCT04717557|183336865|SUPERIORITY||||||>|0.5|||||||Cochran-Mantel-Haenszel|||Underpowered - no statistically significant difference.||||>0.5
91722236|NCT04717557|183336866|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722237|NCT04717557|183336867|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722238|NCT04717557|183336868|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722239|NCT04717557|183336869|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
91722240|NCT06354257|183336870|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of EE.||1.41|0.55|
91722241|NCT06354257|183336870|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.98|1.23|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of LNG.||1.23|0.98|
91722242|NCT06354257|183336871|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of EE.||1.09|0.85|
91527257|NCT00569803|182929907|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
91722243|NCT06354257|183336871|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.97|1.19|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of LNG.||1.19|0.97|
91722244|NCT01654276|183336895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
91722245|NCT00720759|183336927|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_ERROR_OF_MEAN|8.54|<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.||||<0.05
91722246|NCT03100747|183336937|SUPERIORITY||Odds Ratio (OR)|1.21||||0.039|TWO_SIDED|98.3|0.97|1.52||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.52|0.97|0.039
91722247|NCT03100747|183336937|SUPERIORITY||Odds Ratio (OR)|1.91|||<|0.0001|TWO_SIDED|98.3|1.54|2.36||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||2.36|1.54|<0.0001
91489235|NCT00569270|182850961|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Change in IC before and after dynamic hyperinflation. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.0001
91489236|NCT00569270|182850962|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Total lung capacity was similar in all groups and was not significant|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||>0.05
91489237|NCT00569270|182850963|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||A priori threshold for statistical significance: p= 0.05|Spearman rho|Spearman rho = -0.26||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema||||0.36
91489238|NCT04729621|182850973|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45).|Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.73|1.15||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption.||1.15|-0.73|
91527258|NCT00569803|182929907|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.78|||||TWO_SIDED|90.0|0.62|0.99|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||0.99|0.62|
91722248|NCT03100747|183336937|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.0001|TWO_SIDED|98.3|1.29|1.92||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.92|1.29|<0.0001
91722249|NCT03100747|183336942|SUPERIORITY||Odds Ratio (OR)|0.84||||0.094|TWO_SIDED|98.3|0.65|1.08||p-values adjusted for multiple comparisons|Regression, Logistic|||||1.08|0.65|0.094
91722250|NCT03100747|183336942|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|98.3|0.38|0.67||p-value adjusted for multiple comparisons, the a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.67|0.38|<0.0001
91722251|NCT03100747|183336942|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|98.3|0.45|0.8||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.80|0.45|<0.0001
91722252|NCT03100747|183336947|SUPERIORITY||Odds Ratio (OR)|0.86||||0.24|TWO_SIDED|98.3|0.64|1.17|||Regression, Logistic|||||1.17|0.64|0.24
91722253|NCT03100747|183336947|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0037|TWO_SIDED|98.3|0.49|0.93|||Regression, Logistic|||||0.93|0.49|0.0037
91722254|NCT03100747|183336947|SUPERIORITY||Odds Ratio (OR)|0.78||||0.08|TWO_SIDED|98.3|0.57|1.09|||Regression, Logistic|||||1.09|0.57|0.08
91722255|NCT04070703|183337033|SUPERIORITY|The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.|Mean Difference (Final Values)|2.8||||0.0125|TWO_SIDED|98.75|2.1|3.6|||Mixed Models Analysis|||||3.6|2.1|0.0125
91527259|NCT00569803|182929907|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89|||||TWO_SIDED|90.0|0.71|1.13|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.13|0.71|
91527260|NCT00569803|182929907|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.11|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.11|0.69|
91722256|NCT04070703|183337033|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.0125|TWO_SIDED|98.75|0.07|2.2|||Mixed Models Analysis|||||2.2|.07|.0125
91722257|NCT04070703|183337034|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0125|TWO_SIDED|98.75|2.8|16.6|||Mixed Models Analysis|||||16.6|2.8|.0125
91722258|NCT04070703|183337034|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.0125|TWO_SIDED|98.75|12.6|31.2|||Mixed Models Analysis|||||31.2|12.6|.0125
91722259|NCT04070703|183337035|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.05|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||||-.1|-.5|0.05
91722260|NCT04070703|183337035|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.05|TWO_SIDED|95.0|-0.7|-0.3|||Mixed Models Analysis|||||-.3|-.7|.05
91722261|NCT04070703|183337036|SUPERIORITY||Mean Difference (Final Values)|-14.1||||0.05|TWO_SIDED|95.0|-20.0|-8.0|||Mixed Models Analysis|||||-8|-20|.05
91722262|NCT04070703|183337036|SUPERIORITY||Mean Difference (Final Values)|-22.0||||0.05|TWO_SIDED|95.0|-28.0|-16.0|||Mixed Models Analysis|||||-16|-28|.05
91722263|NCT04070703|183337037|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||.1|-.4|<.05
91722264|NCT04070703|183337037|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|0.4|1.2|||Mixed Models Analysis|||||1.2|.4|<.05
91489239|NCT04729621|182850974|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-20, +20).|Mean Difference (Net)|9.07|||||TWO_SIDED|95.0|-0.14|18.29||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 26 in sCTX-1 as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline sCTX-1 and baseline weight as covariates. Missing outcomes are not imputed. Results below the limit of quantification (BLQ) are imputed as the low limit of quantification (LLOQ = 0.033 ng/mL).||18.29|-0.14|
91527261|NCT00569803|182929907|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
91527262|NCT00569803|182929908|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.87|||||TWO_SIDED|90.0|0.69|1.1|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.10|0.69|
91691187|NCT01120184|183275838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Hazard Ratio (HR)|0.91||||0.3075|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3075
91691188|NCT01120184|183275840|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6568|TWO_SIDED|97.5|0.73|1.2|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.20|0.73|0.6568
91691189|NCT01120184|183275840|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.5691|TWO_SIDED|97.5|0.67|1.11|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.11|0.67|0.5691
91691190|NCT01120184|183275842|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|97.5|0.69|1.04|||||Direction of comparison: Trastuzumab Emtasine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.04|0.69|
91691191|NCT01120184|183275842|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|97.5|0.63|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.63|
91691192|NCT01120184|183275844|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|97.5|0.66|0.97|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.97|0.66|
91691193|NCT01120184|183275844|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|97.5|0.65|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.65|
91691194|NCT01120184|183275854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-8.2|||||TWO_SIDED|95.0|-15.9|-0.5|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||-0.5|-15.9|
91691195|NCT01120184|183275854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-3.7|||||TWO_SIDED|95.0|-11.4|3.9|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||3.9|-11.4|
91722265|NCT04070703|183337038|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|0.5|1.6|||Mixed Models Analysis|||||1.6|.5|<.05
91691196|NCT01120184|183275854|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|4.5|||||TWO_SIDED|95.0|-3.3|12.2|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||12.2|-3.3|
91691197|NCT01120184|183275855|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-4.6|||||TWO_SIDED|95.0|-12.1|2.8|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||2.8|-12.1|
91722266|NCT04070703|183337038|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.7|||Mixed Models Analysis|||||2.7|1.6|<.05
91722267|NCT04070703|183337039|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.05|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||||2.1|-.4|<.05
91722268|NCT04070703|183337039|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.05|TWO_SIDED|95.0|3.1|5.0|||Mixed Models Analysis|||||5|3.1|<.05
91722269|NCT04070703|183337040|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||.7|-.3|<.05
91722270|NCT04070703|183337040|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.05|TWO_SIDED|95.0|-2.4|-1.4|||Mixed Models Analysis|||||-1.4|-2.4|<.05
91722271|NCT04070703|183337041|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.05|TWO_SIDED|95.0|-1.4|0.4|||Mixed Models Analysis|||||.4|-1.4|<.05
91722272|NCT04070703|183337041|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.05|TWO_SIDED|95.0|0.8|2.3|||Mixed Models Analysis|||||2.3|.8|<.05
91527263|NCT00569803|182929908|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
91527264|NCT00569803|182929908|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.79|||||TWO_SIDED|90.0|0.62|1.0|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||1.00|0.62|
91691198|NCT01120184|183275855|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.8|||||TWO_SIDED|95.0|-9.2|5.7|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||5.7|-9.2|
91722273|NCT04070703|183337042|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||||1.1|-.1|<.05
91722274|NCT04070703|183337042|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.8|||Mixed Models Analysis|||||2.8|1.6|<.05
91722275|NCT04070703|183337043|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||||.8|-.7|<.05
91722276|NCT04070703|183337043|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-3.1|-1.3|||Mixed Models Analysis|||||-1.3|-3.1|<.05
91722277|NCT04070703|183337044|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.3|1.2|||Mixed Models Analysis|||||1.2|-.3|<.05
91722278|NCT04070703|183337044|SUPERIORITY||Mean Difference (Final Values)|-1.0|||<|0.05|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||||-.2|-1.8|<.05
91722279|NCT04070703|183337045|SUPERIORITY||Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||||2|-.4|<.05
91722280|NCT04070703|183337045|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.05|TWO_SIDED|95.0|3.1|7.9|||Mixed Models Analysis|||||7.9|3.1|<.05
91691199|NCT01120184|183275855|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|2.9|||||TWO_SIDED|95.0|-4.5|10.3|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||10.3|-4.5|
91691200|NCT01120184|183275856|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|97.5|0.43|0.84|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.43|
91691201|NCT01120184|183275856|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|97.5|0.45|0.85|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.85|0.45|
91691202|NCT01120184|183275858|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-32.2|||||TWO_SIDED|95.0|-40.0|-24.0|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-24|-40|
91691203|NCT01120184|183275858|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-24.2|||||TWO_SIDED|95.0|-32.0|-16.0|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-16|-32|
91722281|NCT04070703|183337046|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||.03|-.04|<.05
91722282|NCT04070703|183337046|SUPERIORITY||Mean Difference (Final Values)|0.07|||<|0.05|TWO_SIDED|95.0|0.03|0.11|||Mixed Models Analysis|||||.11|.03|<.05
91722283|NCT04070703|183337047|SUPERIORITY||Mean Difference (Final Values)|4.0|||<|0.05|TWO_SIDED|95.0|-2.0|6.0|||Mixed Models Analysis|||||6|-2|<.05
91722284|NCT04070703|183337047|SUPERIORITY||Mean Difference (Final Values)|125.5|||<|0.05|TWO_SIDED|95.0|84.0|166.0|||Mixed Models Analysis|||||166|84|<.05
91722285|NCT04070703|183337048|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.05|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis|||||-.1|-.3|<.05
91722286|NCT04070703|183337048|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.05|TWO_SIDED|95.0|-0.7|-0.4|||Mixed Models Analysis|||||-.4|-.7|<.05
91722287|NCT05028569|183337063|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly migraine days as covariate, included as a continuous variable rather than the binomial stratification variable. Subject/residual errors are random effects.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33|=|0.914|TWO_SIDED|95.0|-0.62|0.69|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||0.69|-0.62|=0.914
91722288|NCT05028569|183337063|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly migraine days as covariate, included as a continuous variable rather than the binomial stratification variable. Subject/residual errors are random effects.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.33|=|0.745|TWO_SIDED|95.0|-0.76|0.55|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||0.55|-0.76|=0.745
91722289|NCT05028569|183337065|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly headache days as covariate, included as a continuous variable. Subject/residual errors are random effects.|LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.36|=|0.414|TWO_SIDED|95.0|-0.42|1.01|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||1.01|-0.42|=0.414
91527265|NCT00569803|182929908|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.71|1.14|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.14|0.71|
91691204|NCT01120184|183275858|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|8.0|||||TWO_SIDED|95.0|-2.3|18.4|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||18.4|-2.3|
91527266|NCT00569803|182929908|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.12|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.12|0.69|
91691205|NCT01120184|183275862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.57|0.86|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.86|0.57|
91691206|NCT01120184|183275862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.55|0.84|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.55|
91691207|NCT01120184|183275866|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.4|1.15|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.15|0.40|
91691208|NCT01120184|183275867|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.41|1.07|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.07|0.41|
91691209|NCT01120184|183275869|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|97.5|0.65|1.25|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.25|0.65|
91691210|NCT01120184|183275871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|97.5|0.74|1.34|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.34|0.74|
91691211|NCT03190993|183275892|OTHER|Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).|Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.43|=|0.22|TWO_SIDED||||||Regression, Linear|||||||=0.22
91691212|NCT02954601|183275950|OTHER|Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment, Period and Baseline value (for change and percent change) are factors in the model with repeated values for a subject.||||||0.1311|||||||Mixed Models Analysis|||||||0.1311
91691213|NCT02954601|183275953|OTHER|||||||0.3061|TWO_SIDED|95.0|||||Mixed Models Analysis|||Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment period and Baseline value (for change and percent change) are factors in the model with repeated values for subject.||||0.3061
91691214|NCT00471081|183275963|SUPERIORITY||Percentage of subjects with hSBA titers|88.4|||||TWO_SIDED|95.0|81.9|93.2|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.||93.2|81.9|
91691215|NCT00471081|183275963|SUPERIORITY||Percentage of subjects with hSBA titers|100.0|||||TWO_SIDED|95.0|97.3|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 90%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.||100|97.3|
91691216|NCT00471081|183275963|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.||100|96.2|
91691217|NCT00471081|183275963|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.||100|96.2|
91691218|NCT02211209|183276052|SUPERIORITY||Least Squares Mean Difference|-94.1|||<|0.0001|TWO_SIDED|95.0|-121.7|-66.6|||ANCOVA|||||-66.6|-121.7|< 0.0001
91691219|NCT02211209|183276054|SUPERIORITY||Least Squares Mean Difference|-1804.0|STANDARD_ERROR_OF_MEAN|251.0|<|0.0001|TWO_SIDED|95.0|-2306.0|-1302.0|||ANCOVA|||||-1302|-2306|< 0.0001
91691220|NCT02211209|183276055|SUPERIORITY||Odds Ratio (OR)|186.16||||0.0001|TWO_SIDED|95.0|12.86||NA indicates that the upper limit of 95% CI was not estimable. The upper limit of the odds ratio estimate from the logistic regression model was \>999.999, and it was reported as NA per statistical reporting convention.||Regression, Logistic||||||12.86|0.0001
91691221|NCT02211209|183276056|SUPERIORITY||Odds Ratio (OR)|99.69|||<|0.0001|TWO_SIDED|95.0|15.75|631.06|||Regression, Logistic|||||631.06|15.75|<0.0001
91527267|NCT00569803|182929908|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
91527268|NCT00569803|182929914|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
91489240|NCT00134030|182851026|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.214|TWO_SIDED|95.0|0.61|1.12|||Log Rank|||||1.12|0.61|0.214
91489241|NCT00134030|182851026|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.78|1.23|||Log Rank|||||1.23|0.78|0.86
91489242|NCT00134030|182851026|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.69|TWO_SIDED|95.0|-3.3|4.9|||Difference in RMST|||Secondary RMST analysis performed in poor response group, due to evidence of non-proportional hazards.||4.9|-3.3|0.69
91722290|NCT05028569|183337065|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly headache days as covariate, included as a continuous variable. Subject/residual errors are random effects.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.889|TWO_SIDED|95.0|-0.66|0.76|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||0.76|-0.66|=0.889
91722291|NCT05028569|183337066|SUPERIORITY|P-value is obtained from Logistic Regression. Model includes treatment (BOTOX 195 U, BOTOX 155 U, and placebo), country and strata of previous exposure to migraine prophylactic treatment as fixed effects, with the Baseline monthly migraine days as a covariate, included as a continuous variable. Subject and residual errors are random effects in this by visit logistic covariate analysis of variance (ANCOVA). Confidence intervals (Clopper-Pearson) are based on binomial-distribution assumptions.|Response Rate Difference|2.2|||=|0.451|TWO_SIDED|95.0|-7.08|11.46|||Regression, Logistic||Response Rate Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||11.46|-7.08|=0.451
91722292|NCT05028569|183337066|SUPERIORITY|P-value is obtained from Logistic Regression. Model includes treatment (BOTOX 195 U, BOTOX 155 U, and placebo), country and strata of previous exposure to migraine prophylactic treatment as fixed effects, with the Baseline monthly migraine days as a covariate, included as a continuous variable. Subject and residual errors are random effects in this by visit logistic covariate analysis of variance (ANCOVA). Confidence intervals (Clopper-Pearson) are based on binomial-distribution assumptions.|Response Rate Difference|1.2|||=|0.762|TWO_SIDED|95.0|-7.94|10.4|||Regression, Logistic||Response Rate Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||10.40|-7.94|=0.762
91722293|NCT05028569|183337067|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline monthly acute headache medication days as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.31|=|0.686|TWO_SIDED|95.0|-0.48|0.74|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||0.74|-0.48|=0.686
91722294|NCT05028569|183337067|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline monthly acute headache medication days as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.31|=|0.913|TWO_SIDED|95.0|-0.57|0.64|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||0.64|-0.57|=0.913
91722295|NCT05028569|183337068|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the visit at Month 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline MSQ v2.1 RFR Domain Score as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.81|=|0.837|TWO_SIDED|95.0|-3.18|3.93|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||3.93|-3.18|=0.837
91489243|NCT00134030|182851027|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.804|TWO_SIDED|95.0|0.69|1.33|||Log Rank|||||1.33|0.69|0.804
91489244|NCT00134030|182851027|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.674|TWO_SIDED|95.0|0.81|1.39|||Log Rank|||||1.39|0.81|0.674
91489245|NCT02187744|182851046|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.02|6.49|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||6.49|-8.02|
91489246|NCT02187744|182851046|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|95.0|-8.59|6.23|||||Unstratified analysis.|||6.23|-8.59|
91489247|NCT02187744|182851048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-16.58|10.96|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||10.96|-16.58|
91489248|NCT02187744|182851048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|7.35|||TWO_SIDED|95.0|-17.4|11.4|||||Unstratified analysis.|||11.40|-17.40|
91527269|NCT00569803|182929914|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
91527270|NCT02006420|182929923|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin thickness of the forearm.||||0.005
91527271|NCT02006420|182929923|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin stiffness of the thigh||||0.71
91527272|NCT02006420|182929924|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p-value for the forearm||||0.002
91489249|NCT02187744|182851049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|95.0|-4.01|15.94|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||15.94|-4.01|
91489250|NCT02187744|182851049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-4.08|16.27|||||Unstratified analysis.|||16.27|-4.08|
91489251|NCT01972568|182851052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.1208|TWO_SIDED|95.0|0.89|2.72|||Logistic regression model|||||2.72|0.89|0.1208
91489252|NCT01972568|182851060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.31||||0.0048|TWO_SIDED|95.0|1.44|7.61|||Logistic regression model|||||7.61|1.44|0.0048
91489253|NCT01972568|182851061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0202|TWO_SIDED|95.0|1.11|3.46|||Logistic regression model|||||3.46|1.11|0.0202
91489254|NCT00144391|182851081|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91489255|NCT00594659|182851088|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||accelerated bootstrapping|||Pairwise comparison; non-parametric tests performed because of non-normal distribution||||<0.05
91489256|NCT00594659|182851088|SUPERIORITY_OR_OTHER||||||<|0.05|||||||accelerated bootstrapping|||pairwise comparison; non-parametric analysis||||< .05
91489257|NCT00594659|182851088|SUPERIORITY_OR_OTHER||||||>|0.05|||||||accelerated bootstrapping|||nonparametric pairwise comparison; non-normal distribution||||> 0.05
91489258|NCT00594659|182851089|SUPERIORITY_OR_OTHER||Slope|3.11|STANDARD_ERROR_OF_MEAN|0.69|<|0.05|TWO_SIDED||||||piecewise mixed model with logit link an|Performed across all assessments.|Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p \< 0.05. All other pairwise comparisons p \> 0.05.|pairwise comparisons among groups across 4 follow-up timepoints||||< 0.05
91489259|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.29|0.92|
91527273|NCT02006420|182929924|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p-value for the thigh||||0.007
91489260|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.1|||||TWO_SIDED|95.0|0.93|1.31|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.31|0.93|
91489261|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.01|||||TWO_SIDED|95.0|0.85|1.2|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.2|0.85|
91527274|NCT02006420|182929925|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p value for the forearm.||||0.002
91527275|NCT02006420|182929925|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p value for the thigh||||0.007
91527276|NCT02006420|182929927|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the forearm||||<.0001
91527277|NCT02006420|182929927|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the thigh||||<0.0001
91527278|NCT02006420|182929929|SUPERIORITY|||||||0.01|||||||Pearson correlation|||This is the p-value for the forearm||||0.01
91527279|NCT02006420|182929929|SUPERIORITY|||||||0.1|||||||Pearson correlation|||This is the p-value for the thigh||||0.10
91527280|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|5.596|||TWO_SIDED|95.0|-12.68|10.75|||||Comparison of SBP Day 1.|||10.75|-12.68|
91691222|NCT02211209|183276058|SUPERIORITY|||||||0.6131|||||||t-test, 2 sided|||||||0.6131
91691223|NCT02211209|183276059|SUPERIORITY||Least Squares Mean Difference|138.0||||0.1206|TWO_SIDED|95.0|-36.0|312.0|||ANCOVA|||||312|-36|0.1206
91691224|NCT03889418|183276065|SUPERIORITY||Odds Ratio, log|-0.009|STANDARD_ERROR_OF_MEAN|0.153||0.956|TWO_SIDED|95.0|-0.309|0.292|||Mixed Models Analysis|||||0.292|-0.309|0.956
91489262|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 Strain)|1.12|||||TWO_SIDED|95.0|0.97|1.3|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.3|0.97|
91489263|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.85|1.13|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.13|0.85|
91489264|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.87|||||TWO_SIDED|95.0|0.76|1.01|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.01|0.76|
91489265|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.06|||||TWO_SIDED|95.0|0.91|1.23|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.23|0.91|
91489266|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.33|0.99|
91722296|NCT05028569|183337068|SUPERIORITY|P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the visit at Month 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline MSQ v2.1 RFR Domain Score as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.79|=|0.662|TWO_SIDED|95.0|-2.74|4.31|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||4.31|-2.74|=0.662
91722297|NCT05028569|183337069|SUPERIORITY|P-value/95% CI are obtained from mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline AIM-D Physical Impairment domain score as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.75|=|0.834|TWO_SIDED|95.0|-1.32|1.63|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||1.63|-1.32|=0.834
91691225|NCT03889418|183276066|SUPERIORITY||Risk Ratio, log|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.039|TWO_SIDED|95.0|-0.2|-0.005|||Mixed Models Analysis|||||-.005|-0.200|0.039
91722298|NCT05028569|183337069|SUPERIORITY|P-value/95% CI are obtained from mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline AIM-D Physical Impairment domain score as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.75|=|0.578|TWO_SIDED|95.0|-1.06|1.9|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||1.90|-1.06|=0.578
91722299|NCT05028569|183337070|SUPERIORITY|P-value/95% CI are obtained from a mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline total HIT-6 score as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.68|=|0.589|TWO_SIDED|95.0|-1.69|0.96|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 195 U - Placebo|BOTOX 195 U vs Placebo||0.96|-1.69|=0.589
91722300|NCT05028569|183337070|SUPERIORITY|P-value/95% CI are obtained from a mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline total HIT-6 score as a covariate, included as a continuous variable. Subject and residual errors are random effects.|LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.67|=|0.31|TWO_SIDED|95.0|-2.0|0.64|||Mixed Model for Repeated Measures (MMRM)||LS Mean Difference = BOTOX 155 U - Placebo|BOTOX 155 U vs Placebo||0.64|-2.00|=0.310
91691226|NCT03889418|183276067|SUPERIORITY||Rate Ratio, log|0.049|STANDARD_ERROR_OF_MEAN|0.282||0.864|TWO_SIDED|95.0|-0.506|0.603|||Mixed Models Analysis|||||0.603|-0.506|0.864
91691227|NCT03889418|183276068|SUPERIORITY||rate ratio, log|0.018|STANDARD_ERROR_OF_MEAN|0.148||0.901|TWO_SIDED|95.0|-0.272|0.308|||Mixed Models Analysis|||||0.308|-0.272|0.901
91691228|NCT04910100|183276112|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|6.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
91691229|NCT04910100|183276112|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|9.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
91691230|NCT04910100|183276112|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
91691231|NCT04910100|183276112|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
91722525|NCT02629159|183337897|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.372|-0.253||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.253|-0.372|<0.001
91489267|NCT00617851|182851185|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.09|||||TWO_SIDED|95.0|0.94|1.26|||ANOVA||"The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.26|0.94|
91489268|NCT00944671|182851210|NON_INFERIORITY_OR_EQUIVALENCE|Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
91489269|NCT00944671|182851211|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.13||||||||1.13|0.93|
91489270|NCT00944671|182851212|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
91691232|NCT04910100|183276112|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
91691233|NCT04910100|183276112|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
91691234|NCT01256879|183276195|OTHER|Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC.|||||||||||||||||Bioequivalence testing of AUC, per FDA guidance, is applied. Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC. The upper and lower 90% Confidence Interval for CimTest-A is 104.4% to 120.6%. The upper and lower 90% Confidence Interval for CimTest-B is 97.9% to 113.0%. The upper and lower 90% Confidence Interval for Commercial Cimetidine Solution is 93.2% to 107.7%.|||
91691235|NCT02964247|183276198|SUPERIORITY||Treatment difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.89|-0.48|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in HbA1c from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate.||-0.48|-0.89|<.001
91691236|NCT02964247|183276198|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.74|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.94|-0.53|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand.The change in HbA1c from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate, all nested within visit.||-0.53|-0.94|<.001
91691237|NCT02964247|183276199|SUPERIORITY||Treatment difference|-0.82|STANDARD_ERROR_OF_MEAN|0.46||0.077|TWO_SIDED|95.0|-1.73|0.09|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in body weight from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate.||0.09|-1.73|0.077
91691238|NCT02964247|183276199|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.062|TWO_SIDED|95.0|-1.77|0.04|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand. The change in body weight from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate, all nested within visit.||0.04|-1.77|0.062
91691239|NCT00725920|183276224|SUPERIORITY_OR_OTHER|||||||0.0076||95.0|||||t-test, 2 sided|||||||0.0076
91691240|NCT00359424|183276225|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.7031|TWO_SIDED|95.0|-6.1|9.1||The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).||9.1|-6.1|.7031
91489271|NCT00944671|182851213|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
91489272|NCT01479478|182851242|SUPERIORITY|||||||0.87|||||||Cochran-Mantel-Haenszel|||||||0.87
91489273|NCT00142935|182851265|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||Outcome: engage in treatment post release, yes or no||||<0.001
91691241|NCT00359424|183276226|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.5241|TWO_SIDED|99.0|-10.3|6.2||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).||6.2|-10.3|.5241
91691242|NCT00359424|183276227|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.8275|TWO_SIDED|99.0|-4.6|5.5||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).||5.5|-4.6|.8275
91691243|NCT03832686|183276253|OTHER|||||||0.86||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.86
91722526|NCT02629159|183337897|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.184|-0.036||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.036|-0.184|0.004
91691244|NCT03832686|183276254|OTHER|||||||0.69||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.69
91691245|NCT03832686|183276255|OTHER|||||||0.47||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Eating in Public Score||||0.47
91691246|NCT03832686|183276255|OTHER|||||||0.73||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Normalcy of Diet score||||0.73
91489274|NCT00142935|182851266|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared, Corrected|||||||.02
91691247|NCT03832686|183276256|OTHER|||||||0.65||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Oral score||||0.65
91691248|NCT03832686|183276256|OTHER|||||||0.24||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Pharyngeal score||||0.24
91489275|NCT00142935|182851267|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared, Corrected|||||||.09
91489276|NCT00142935|182851268|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared, Corrected|||||||.09
91691249|NCT03832686|183276257|OTHER|||||||0.53||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.53
91691250|NCT03832686|183276258|OTHER|||||||0.5||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.50
91691251|NCT05479435|183276283|OTHER|||||||0.83|||||||Kruskal-Wallis|||||||0.830
91489277|NCT00142935|182851270|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared, Corrected|||||||0.8
91489278|NCT00705289|182851288|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|0.1402||||0.0003|||||||Test for non-zero correlation|||Relationship between baseline DAS28 and age (prior to infliximab therapy)||||0.0003
91489279|NCT00705289|182851289|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|-0.01||||0.7991||95.0|||||Test for non-zero correlation|||Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)||||0.7991
91489280|NCT00705289|182851290|SUPERIORITY_OR_OTHER|||||||0.7152||95.0|||||ANOVA|The association between Baseline DAS28 and gender is based on a one-way Anova.||Relationship between baseline DAS28 and gender (prior to infliximab therapy)||||0.7152
91722527|NCT02629159|183337898|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Response Rate Difference|16.1|||||TWO_SIDED|95.0|9.9|22.3|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.3|9.9|
91489281|NCT00705289|182851291|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.||Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)||||<0.0001
91489282|NCT00705289|182851292|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.15||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)||5.3|5.1|
91489283|NCT00705289|182851292|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.0|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)||5.5|5.0|
91489284|NCT00705289|182851292|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.14||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)||5.3|5.1|
91691252|NCT05479435|183276284|OTHER|||||||0.654|||||||ANCOVA|||||||0.654
91691253|NCT05479435|183276285|OTHER|||||||0.803|||||||ANCOVA|||||||0.803
91691254|NCT05479435|183276286|OTHER|||||||0.398|||||||ANCOVA|||||||0.398
91691255|NCT05479435|183276287|OTHER|||||||0.132|||||||Kruskal-Wallis|||||||0.132
91691256|NCT05479435|183276288|OTHER|||||||0.991|||||||Kruskal-Wallis|||||||0.991
91691257|NCT05479435|183276289|OTHER|||||||0.278|||||||Kruskal-Wallis|||||||0.278
91691258|NCT05479435|183276290|OTHER|||||||0.479|||||||ANCOVA|||||||0.479
91489285|NCT00705289|182851292|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.1|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)||5.5|5.1|
91489286|NCT00304746|182851315|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.|mixed effects linear regression analysis|||Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.||||0.71
91527281|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|4.215|||TWO_SIDED|95.0|-12.92|4.72|||||Comparison of SBP Day 7.|||4.72|-12.92|
91527282|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.21|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-5.78|18.19|||||Comparison of SBP Day 1.|||18.19|-5.78|
91527283|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.76|STANDARD_ERROR_OF_MEAN|4.314|||TWO_SIDED|95.0|-13.79|4.27|||||Comparison of SBP Day 7.|||4.27|-13.79|
91691259|NCT05479435|183276291|OTHER|||||||0.849|||||||Kruskal-Wallis|||||||0.849
91691260|NCT05479435|183276292|OTHER|||||||0.504|||||||Kruskal-Wallis|||||||0.504
91691261|NCT05479435|183276293|OTHER|||||||0.017|||||||ANCOVA|||||||0.017
91691262|NCT05479435|183276294|OTHER|||||||0.025|||||||Kruskal-Wallis|||||||0.025
91691263|NCT05479435|183276295|OTHER|||||||0.016|||||||ANCOVA|||||||0.016
91691264|NCT05479435|183276296|OTHER|||||||0.041|||||||ANCOVA|||||||0.041
91691265|NCT05479435|183276297|OTHER|||||||0.352|||||||Kruskal-Wallis|||||||0.352
91691266|NCT05479435|183276298|OTHER|||||||0.39|||||||Kruskal-Wallis|||||||0.390
91691267|NCT05479435|183276299|OTHER|||||||0.928|||||||ANCOVA|||||||0.928
91691268|NCT05479435|183276300|OTHER|||||||0.558|||||||Kruskal-Wallis|||||||0.558
91691269|NCT05479435|183276301|OTHER|||||||0.133|||||||Kruskal-Wallis|||||||0.133
91691270|NCT05479435|183276302|OTHER|||||||0.367|||||||Kruskal-Wallis|||||||0.367
91691271|NCT05479435|183276303|OTHER|||||||0.631|||||||ANCOVA|||||||0.631
91691272|NCT05479435|183276304|OTHER|||||||0.056|||||||ANCOVA|||||||0.056
91691273|NCT05479435|183276305|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
91691274|NCT05479435|183276306|OTHER|||||||0.377|||||||ANCOVA|||||||0.377
91691275|NCT05479435|183276307|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
91691276|NCT05479435|183276308|OTHER|||||||0.055|||||||ANCOVA|||||||0.055
91691277|NCT03055338|183276332|SUPERIORITY||Difference in LSM|2.6||||0.44|TWO_SIDED|95.0|-4.0|9.2|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Risperidone|||9.2|-4.0|0.440
91691278|NCT03055338|183276332|SUPERIORITY||Difference in LSM|-4.7||||0.074|TWO_SIDED|95.0|-9.8|0.5|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Placebo|||0.5|-9.8|0.074
91691279|NCT03055338|183276332|SUPERIORITY||Difference in LSM|-7.3||||0.033|TWO_SIDED|95.0|-14.0|-0.6|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = Risperidone - Placebo|||-0.6|-14.0|0.033
91691280|NCT03055338|183276333|OTHER||Difference in % versus Placebo|17.2|||||TWO_SIDED|95.0|3.0|30.8|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|30.8|3.0|
91722301|NCT04609553|183337071|SUPERIORITY|||||||0.64||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. Specifically, no adjustments were made for child expressive language since it was only measured at 18 months.|||0.64
91489287|NCT01431989|182851316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|90.03|STANDARD_DEVIATION|7.53||0|TWO_SIDED|90.0|86.99|93.17|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.17|86.99|0.0000
91527284|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.138|||TWO_SIDED|95.0|-3.89|5.06|||||Comparison of DBP Day 1.|||5.06|-3.89|
91527285|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.64|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-11.62|-1.65|||||Comparison of DBP Day 7.|||-1.65|-11.62|
91527286|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.248|||TWO_SIDED|95.0|-3.73|5.68|||||Comparison of DBP Day 1.|||5.68|-3.73|
91691281|NCT03055338|183276334|OTHER||Difference in % versus Placebo|-1.2|||||TWO_SIDED|95.0|-9.6|7.0|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|7.0|-9.6|
91691282|NCT03055338|183276335|OTHER||Difference in LSM|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Difference in LSM = MK-8189 - Risperidone|||0.6|-0.2|
91691283|NCT03055338|183276335|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|95.0|-0.5|0.2|||||Difference in LSM = MK-8189 - Placebo|||0.2|-0.5|
91691284|NCT03055338|183276335|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|95.0|-0.8|0.1|||||Difference in LSM = Risperidone - Placebo|||0.1|-0.8|
91691285|NCT01415518|183276343|SUPERIORITY_OR_OTHER||Ratio|1.069|||<|0.0001|TWO_SIDED|95.0|1.043|1.096|||ANCOVA|multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.096|1.043|<.0001
91691286|NCT01415518|183276344|SUPERIORITY_OR_OTHER||Ratio|1.067|||<|0.0001|TWO_SIDED|95.0|1.044|1.09|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.090|1.044|<.0001
91691287|NCT01415518|183276345|SUPERIORITY_OR_OTHER||Ratio|1.068|||<|0.0001||95.0|1.043|1.092|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.092|1.043|<.0001
91691288|NCT01415518|183276346|SUPERIORITY_OR_OTHER||Ratio|1.04||||0.0007|TWO_SIDED|95.0|1.017|1.064|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.064|1.017|0.0007
91691289|NCT01415518|183276347|SUPERIORITY_OR_OTHER||Ratio|1.045|||<|0.0001|TWO_SIDED|95.0|1.024|1.065|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.065|1.024|<.0001
91527287|NCT00453479|182929946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.81|STANDARD_ERROR_OF_MEAN|2.504|||TWO_SIDED|95.0|-16.05|-5.57|||||Comparison of DBP Day 7.|||-5.57|-16.05|
91722528|NCT02629159|183337898|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|||||<|0.001||||||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.||||||<0.001
91527288|NCT00453479|182929947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|3.745|||TWO_SIDED|95.0|-5.58|10.1|||||Comparison at Day 1.|||10.10|-5.58|
91527289|NCT00453479|182929947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|STANDARD_ERROR_OF_MEAN|3.785|||TWO_SIDED|95.0|-5.3|10.54|||||Comparison at Day 7.|||10.54|-5.30|
91691290|NCT01415518|183276348|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0003|TWO_SIDED|95.0|1.017|1.06|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.060|1.017|0.0003
91691291|NCT01415518|183276349|SUPERIORITY_OR_OTHER||Ratio|1.035||||0.0248|TWO_SIDED|95.0|1.004|1.066|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.066|1.004|0.0248
91691292|NCT01415518|183276350|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0074|TWO_SIDED|95.0|1.01|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.067|1.010|0.0074
91527290|NCT00453479|182929947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|3.979|||TWO_SIDED|95.0|-8.17|8.48|||||Comparison at Day 1.|||8.48|-8.17|
91691293|NCT01415518|183276351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.172||||0.0001|TWO_SIDED|95.0|12.733|37.611|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||37.611|12.733|0.0001
91691294|NCT01415518|183276352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.136|||<|0.0001|TWO_SIDED|95.0|12.163|30.11|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.110|12.163|<.0001
91691295|NCT01415518|183276353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.044|||<|0.0001|TWO_SIDED|95.0|14.927|31.161|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||31.161|14.927|<.0001
91489288|NCT01431989|182851317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|87.93|STANDARD_DEVIATION|13.83||0.0018|TWO_SIDED|90.0|82.55|93.65|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.65|82.55|0.0018
91527291|NCT00453479|182929947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.44|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|-13.86|2.97|||||Comparison at Day 7.|||2.97|-13.86|
91722529|NCT02629159|183337898|SUPERIORITY||Response Rate Difference|30.3|||<|0.001|TWO_SIDED|95.0|25.6|35.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.0|25.6|<0.001
91691296|NCT01415518|183276354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.513|||<|0.0001|TWO_SIDED|95.0|18.74|44.286|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||44.286|18.740|<.0001
91691297|NCT01415518|183276355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.322|||<|0.0001|TWO_SIDED|95.0|14.425|34.22|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||34.220|14.425|<.0001
91691298|NCT01415518|183276356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.168|||<|0.0001|TWO_SIDED|95.0|18.906|35.431|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||35.431|18.906|<.0001
91691299|NCT01415518|183276357|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.0102|TWO_SIDED|95.0|-0.522|-0.071|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.071|-0.522|0.0102
91691300|NCT01415518|183276358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.0004|TWO_SIDED|95.0|-0.533|-0.153|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.153|-0.533|0.0004
91691301|NCT01415518|183276359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.0002|TWO_SIDED|95.0|-0.523|-0.162|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.162|-0.523|0.0002
91691302|NCT01415518|183276360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279|||<|0.0001|TWO_SIDED|95.0|-0.381|-0.177|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.177|-0.381|<.0001
91691303|NCT01415518|183276361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.193||||0.0002|TWO_SIDED|95.0|-0.294|-0.092|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.092|-0.294|0.0002
91691304|NCT01415518|183276362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.208||||0.0001|TWO_SIDED|95.0|-0.308|-0.108|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.108|-0.308|0.0001
91691305|NCT01415518|183276363|SUPERIORITY_OR_OTHER||Rate ratio|0.565||||0.0425|TWO_SIDED|95.0|0.325|0.981|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable||||0.981|0.325|0.0425
91691306|NCT01415518|183276363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.604||||0.088|TWO_SIDED|95.0|0.339|1.078|||Regression, Cox|Time to the first COPD exacerbation||||1.078|0.339|0.0880
91691307|NCT01415518|183276363|SUPERIORITY_OR_OTHER|||||||0.0845|||||||Log Rank|Time to the first COPD exacerbation||||||0.0845
91691308|NCT01415518|183276364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.055||||0.2281|TWO_SIDED|95.0|-0.144|0.035|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||0.035|-0.144|0.2281
91691309|NCT01415518|183276365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.001|TWO_SIDED|95.0|-0.194|-0.049|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.049|-0.194|0.0010
91691310|NCT01415518|183276366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106||||0.0073|TWO_SIDED|95.0|-0.183|-0.029|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.029|-0.183|0.0073
91527292|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.78|STANDARD_ERROR_OF_MEAN|4.611|||TWO_SIDED|95.0|-12.43|6.87|||||Comparison of SBP Day 1.|||6.87|-12.43|
91691311|NCT02999269|183276367|SUPERIORITY|||||||0.04||||||p-value for time by amplitude interaction|Regression, Linear|||For the primary outcomes (change in HDRS24), we performed a full longitudinal model with an unstructured repeated measures covariance matrix on subjects who completed the study in the assigned treatment arm. The dependent variable was HDRS at each visit and the independent variables included progress (time within the ECT series: pre-, mid-, and post-ECT), amplitude, age, sex, pulse width and the following interactions: progress/amplitude, progress/sex, and progress/pulse width.|Time-by-amplitude interaction (F4, 72 = 2.65, p = 0.04).|||0.04
91691312|NCT02999269|183276367|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
91691313|NCT02999269|183276368|SUPERIORITY|||||||0.37|||||||Regression, Linear|||||||0.37
91691314|NCT02999269|183276368|SUPERIORITY|||||||0.5||||||p-value is time-by-amplitude interaction|Regression, Linear|||||||0.50
91691315|NCT02999269|183276368|SUPERIORITY||||||<|0.01||||||Progress (F2,71 = 11.15, p \< 0.01)|Regression, Linear|||||||< 0.01
91691316|NCT01256164|183276369|NON_INFERIORITY_OR_EQUIVALENCE|With 90 subjects, randomized on a 2:1 ratio into the Fibrocaps plus gelatin sponge active arm or the gelatin sponge arm, and assuming a mean TTH of 3.5 minutes with a standard deviation of 2.5 minutes in the active arm and a mean TTH of 6 minutes in the control arm, this translates in a power of 99.4% at a two-sided significance level alpha of 5%, using a two-sample t-test.|||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91691317|NCT01256164|183276370|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||||||1.00
91691318|NCT01256164|183276371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Intent-to-treat analysis||||<0.001
91691319|NCT01256164|183276372|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||intent-to- treat analysis||||0.001
91489289|NCT01431989|182851318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric means T/R formulation|90.03|STANDARD_DEVIATION|7.51||0|TWO_SIDED|90.0|86.96|93.12|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.12|86.96|0.0000
91691320|NCT01256164|183276373|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||intent-to-treat analysis||||0.003
91691321|NCT03752970|183276386|OTHER||Risk Difference (RD)|-0.609|||||TWO_SIDED|95.0|-0.88|-0.186||||||||-0.186|-0.880|
91527293|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|3.913|||TWO_SIDED|95.0|-10.07|6.31|||||Comparison of SBP Day 7.|||6.31|-10.07|
91691322|NCT03752970|183276387|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
91691323|NCT03752970|183276388|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
91691324|NCT03976362|183276389|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.004|TWO_SIDED|95.0|0.63|0.93||One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||0.93|0.63|0.0040
91691325|NCT03976362|183276390|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5481|TWO_SIDED|95.0|0.83|1.24||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.24|0.83|0.5481
91691326|NCT03976362|183276393|OTHER||Difference in LS Means|0.37||||0.8238|TWO_SIDED|95.0|-2.91|3.66||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.66|-2.91|0.8238
91691327|NCT03976362|183276394|OTHER||Hazard Ratio (HR)|0.87||||0.3083|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|||1.14|0.66|0.3083
91489290|NCT01431989|182851319|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Median Difference (Final Values)|0.125||||0.339|TWO_SIDED|90.0|-0.125|0.375|||Wilcoxon (Mann-Whitney)|The non-parametric method included the following factors: Sequence, Formulation, Period, Formulation and Residual||||0.375|-0.125|0.3390
91489291|NCT03345914|182851323|SUPERIORITY||Percentage difference|18.1|||=|0.0004|TWO_SIDED|95.0|8.28|27.97||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kilograms (kg) or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||27.97|8.28|= 0.0004
91489292|NCT03345914|182851323|SUPERIORITY||Percentage difference|21.4|||<|0.0001|TWO_SIDED|95.0|11.36|31.45||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||31.45|11.36|< 0.0001
91691328|NCT03976362|183276395|OTHER||Difference in Least Square Means|1.68||||0.4686|TWO_SIDED|95.0|-2.87|6.23||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||6.23|-2.87|0.4686
91527294|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.01|STANDARD_ERROR_OF_MEAN|4.718|||TWO_SIDED|95.0|-6.87|12.88|||||Comparison of SBP Day 1.|||12.88|-6.87|
91527295|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|4.005|||TWO_SIDED|95.0|-11.88|4.89|||||Comparison of SBP Day 7.|||4.89|-11.88|
91527296|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.822|||TWO_SIDED|95.0|-4.09|3.54|||||Comparison of DBP Day 1.|||3.54|-4.09|
91527297|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.89|STANDARD_ERROR_OF_MEAN|2.116|||TWO_SIDED|95.0|-8.32|0.54|||||Comparison of DBP Day 7.|||0.54|-8.32|
91691329|NCT03976362|183276396|OTHER||Hazard Ratio (HR)|1.01||||0.9174|TWO_SIDED|95.0|0.76|1.35||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.35|0.76|0.9174
91691330|NCT03976362|183276397|OTHER||Difference in Least Square Means|3.83||||0.0245|TWO_SIDED|95.0|0.5|7.16||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||7.16|0.50|0.0245
91691331|NCT03976362|183276398|OTHER||Hazard Ratio (HR)|1.24||||0.2133|TWO_SIDED|95.0|0.88|1.75||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.75|0.88|0.2133
91691332|NCT03976362|183276399|OTHER||Hazard Ratio (HR)|0.18||||0.9381|TWO_SIDED|95.0|-4.27|4.62||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||4.62|-4.27|0.9381
91691333|NCT03976362|183276400|OTHER||Hazard Ratio (HR)|0.97||||0.8464|TWO_SIDED|95.0|0.72|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.72|0.8464
91691334|NCT03976362|183276401|OTHER||Difference in Least Square Means|-2.81||||0.087|TWO_SIDED|95.0|-6.02|0.41||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||0.41|-6.02|0.0870
91691335|NCT03976362|183276402|OTHER||Hazard Ratio (HR)|1.6||||0.002|TWO_SIDED|95.0|1.18|2.16||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||2.16|1.18|0.0020
91691336|NCT01467713|183276424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.286|TWO_SIDED|98.3|0.42|1.39|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.39|0.42|0.286
91691337|NCT01467713|183276424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.332|TWO_SIDED|98.3|0.43|1.43|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.43|0.43|0.332
91489293|NCT03345914|182851324|SUPERIORITY||Percentage difference|40.4|||<|0.0001|TWO_SIDED|95.0|28.95|51.82||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||51.82|28.95|< 0.0001
91489294|NCT03345914|182851324|SUPERIORITY||Percentage difference|42.8|||<|0.0001|TWO_SIDED|95.0|31.54|54.15||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||54.15|31.54|< 0.0001
91691338|NCT01467713|183276424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.808|TWO_SIDED|98.3|0.6|1.86|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.86|0.60|0.808
91527298|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|1.916|||TWO_SIDED|95.0|-5.76|2.26|||||Comparison of DBP Day 1.|||2.26|-5.76|
91527299|NCT00453479|182929948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.39|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|95.0|-14.04|-4.73|||||Comparison of DBP Day 7.|||-4.73|-14.04|
91691339|NCT01467713|183276424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.286|TWO_SIDED|98.3|0.48|1.61|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.61|0.48|0.286
91691340|NCT01467713|183276424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.332|TWO_SIDED|98.3|0.42|1.49|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.49|0.42|0.332
91691341|NCT01467713|183276424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.808|TWO_SIDED|98.3|0.6|1.95|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.95|0.60|0.808
91691342|NCT04846569|183276436|SUPERIORITY||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.38|0.39||||||||0.39|-0.38|
91722302|NCT04609553|183337071|SUPERIORITY|||||||0.46||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. Specifically, no adjustments were made for child expressive language since it was only measured at 18 months.|||0.46
91691343|NCT04846569|183276437|SUPERIORITY||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.78|0.47||||||||0.47|-0.78|
91691344|NCT04846569|183276438|SUPERIORITY|||||||||||||||||All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated.|All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated as originally planned.|||
91691345|NCT04846569|183276439|SUPERIORITY||Median Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.53||||||||0.53|-0.20|
91691346|NCT04846569|183276440|OTHER|Qualitative data analysis|||||||||||||||||Thematic qualitative data analysis was conducted to determine the count of participants reporting positively about the intervention|||
91691347|NCT05251337|183276502|SUPERIORITY|||||||0.462|||||||Mixed Models Analysis|||||||0.462
91691348|NCT05251337|183276503|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
91691349|NCT05251337|183276505|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
91691350|NCT02342678|183276618|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||||2.2|-0.3|0.13
91691351|NCT02342678|183276619|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.18|TWO_SIDED|95.0|-0.2|1.1|||ANCOVA|||||1.1|-0.2|0.18
91691352|NCT02342678|183276620|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||ANCOVA|||||1.3|-1.2|0.89
91691353|NCT02342678|183276621|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.0|||ANCOVA|||||2.0|-0.3|0.13
91691354|NCT02342678|183276622|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.73|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.73
91691355|NCT02342678|183276623|SUPERIORITY||Mean Difference (Final Values)|-19.3||||0.38|TWO_SIDED|95.0|-62.9|24.3|||ANCOVA|||||24.3|-62.9|0.38
91691356|NCT02342678|183276624|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.24|TWO_SIDED|95.0|-3.7|14.8|||ANCOVA|||||14.8|-3.7|0.24
91691357|NCT02342678|183276625|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.46
91691358|NCT00460603|183276626|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.585||||0.9726|TWO_SIDED|95.0|0.332|1.031|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus \[vs.\] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.031|0.332|0.9726
91691359|NCT00460603|183276626|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.735||||0.8391|TWO_SIDED|95.0|0.399|1.352|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.352|0.399|0.8391
91691360|NCT00460603|183276626|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.797||||0.8192|TWO_SIDED|95.0|0.489|1.299|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.299|0.489|0.8192
91722303|NCT04609553|183337072|SUPERIORITY|||||||0.84||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.84
91489295|NCT03345914|182851325|SUPERIORITY||Least Square Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-36.33|-23.24||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.24|-36.33|< 0.0001
91489296|NCT03345914|182851325|SUPERIORITY||Least Square Mean Difference|-33.4|||<|0.0001|TWO_SIDED|95.0|-40.06|-26.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.82|-40.06|< 0.0001
91691361|NCT00460603|183276658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5699|TWO_SIDED|95.0|0.47|2.45|||Log Rank|||Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.45|0.47|0.5699
91691362|NCT00460603|183276658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.2167|TWO_SIDED|95.0|0.33|1.61|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.61|0.33|0.2167
91691363|NCT00460603|183276658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.8746|TWO_SIDED|95.0|0.75|2.98|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.98|0.75|0.8746
91527300|NCT00453479|182929949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.52|5.79|||||Comparison at Day 1.|||5.79|-5.52|
91527301|NCT00453479|182929949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|2.813|||TWO_SIDED|95.0|-3.5|8.28|||||Comparison at Day 7.|||8.28|-3.50|
91527302|NCT00453479|182929949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67|STANDARD_ERROR_OF_MEAN|2.869|||TWO_SIDED|95.0|-8.67|3.34|||||Comparison at Day 1.|||3.34|-8.67|
91691364|NCT00460603|183276659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8884|TWO_SIDED|95.0|0.81|2.41|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.41|0.81|0.8884
91691365|NCT00460603|183276659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.6648|TWO_SIDED|95.0|0.66|1.89|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.89|0.66|0.6648
91691366|NCT00460603|183276659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.8065|TWO_SIDED|95.0|0.75|2.07|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.07|0.75|0.8065
91722530|NCT02629159|183337899|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|3.52|5.15||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|3.52|<0.001
91527303|NCT00453479|182929949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|2.989|||TWO_SIDED|95.0|-10.1|2.41|||||Comparison at Day 7.|||2.41|-10.10|
91691367|NCT00460603|183276660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.6904|TWO_SIDED|95.0|0.656|2.033|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.033|0.656|0.6904
91691368|NCT00460603|183276660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.7364|TWO_SIDED|95.0|0.676|2.141|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.141|0.676|0.7364
91691369|NCT00460603|183276660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.414|TWO_SIDED|95.0|0.535|1.653|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.653|0.535|0.4140
91691370|NCT01651117|183276673|EQUIVALENCE|Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.|Mean Difference (Final Values)|-0.3268|STANDARD_ERROR_OF_MEAN|0.1739||0.0611|TWO_SIDED|95.0|-0.669|0.0154||Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).|Mixed Models Analysis|Multiple imputation used for intent-to-treat analysis.|Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.|||0.0154|-0.6690|0.0611
91691371|NCT03808948|183276708|OTHER||Odds Ratio (OR)|0.62||||0.4842|TWO_SIDED|95.0|0.08|1.97|||Regression, Logistic|||Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome||1.97|0.08|0.4842
91691372|NCT03982511|183276784|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given that this is a pilot RCT, primary aim is to estimate effect sizes for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
91691373|NCT03982511|183276784|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI z-score from T3 to T1|Effect size: -0.01|||.98
91691374|NCT03982511|183276784|SUPERIORITY||Mean Difference (Net)|1.93|STANDARD_ERROR_OF_MEAN|3.97||0.63|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T2 to T1|Effect size: 0.24|||0.63
91691375|NCT03982511|183276784|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|4.51||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T3 to T1|Effect size: 0.03|||0.96
91691376|NCT03982511|183276785|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for Emotion regulation subscale from T2 to T1|Effect size: 0.79|||0.12
91691377|NCT03982511|183276785|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for emotion regulation subscale from T3 to T1|Effect size: -0.02|||0.96
91691378|NCT03982511|183276786|SUPERIORITY||Mean Difference (Net)|-6.08|STANDARD_ERROR_OF_MEAN|5.42||0.28|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T2 to T1|Effect size: -0.41|||0.28
91691379|NCT03982511|183276786|SUPERIORITY||Mean Difference (Net)|5.83|STANDARD_ERROR_OF_MEAN|7.17||0.43|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T3 to T1|Effect size: 0.42|||0.43
91691380|NCT03982511|183276787|SUPERIORITY||Mean Difference (Net)|35.32|STANDARD_ERROR_OF_MEAN|23.86||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T2 to T1|Effect size: 0.85|||0.16
91691381|NCT03982511|183276787|SUPERIORITY|Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|Mean Difference (Net)|16.09|STANDARD_ERROR_OF_MEAN|30.32||0.61|TWO_SIDED||||||ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T3 to T1|Effect size: 0.35|||0.61
91527304|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|STANDARD_ERROR_OF_MEAN|8.157|||TWO_SIDED|95.0|-12.66|21.49|||||Comparison of QTcB Day 1.|||21.49|-12.66|
91489297|NCT03345914|182851326|SUPERIORITY||Least Square Mean Difference|-31.0|||<|0.0001|TWO_SIDED|95.0|-38.76|-23.26||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.26|-38.76|< 0.0001
91527305|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.02|STANDARD_ERROR_OF_MEAN|6.76|||TWO_SIDED|95.0|-5.13|23.17|||||Comparison of QTcB Day 7.|||23.17|-5.13|
91527306|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.57|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-7.24|28.38|||||Comparison of QTcB Day 1.|||28.38|-7.24|
91691382|NCT03982511|183276787|SUPERIORITY||Mean Difference (Net)|-64.4|STANDARD_ERROR_OF_MEAN|54.5||0.26|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for sedentary minutes from T2 to T1|Effect size: -0.68|||0.26
91691383|NCT03982511|183276787|SUPERIORITY||Mean Difference (Net)|66.25|STANDARD_ERROR_OF_MEAN|66.43||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference score for sedentary minutes from T3 to T1|effect size: 0.66|||0.34
91691384|NCT03982511|183276788|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.75||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T2 to T1|effect size: -0.41|||0.41
91691385|NCT03982511|183276788|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T3 to T1|effect size: 0.76|||0.16
91691386|NCT03982511|183276789|SUPERIORITY||Mean Difference (Net)|-12.62|STANDARD_ERROR_OF_MEAN|14.84||0.42|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T2 to T1|effect size: -0.54|||0.42
91691387|NCT03982511|183276789|SUPERIORITY||Mean Difference (Net)|-38.83|STANDARD_ERROR_OF_MEAN|16.61||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T3 to T1|effect size: -1.56|||0.04
91691388|NCT03982511|183276790|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T2 to T1|effect size: 0.15|||0.77
91691389|NCT03982511|183276790|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.28||0.47|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T3 to T1|effect size: -0.38|||0.47
91691390|NCT03982511|183276791|SUPERIORITY||Mean Difference (Net)|9.11|STANDARD_ERROR_OF_MEAN|2.76||0.005|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T2 to T1|effect size: 1.65|||0.005
91691391|NCT03982511|183276791|SUPERIORITY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.81||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T3 to T1|effect size: 1.20|||0.05
91691392|NCT03982511|183276792|SUPERIORITY||Mean Difference (Net)|-17.23|STANDARD_ERROR_OF_MEAN|6.93||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T2 to T1.|effect size: -1.21|||0.02
91691393|NCT03982511|183276792|SUPERIORITY||Mean Difference (Net)|-19.43|STANDARD_ERROR_OF_MEAN|6.4||0.008|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T3 to T1|effect size: -1.57|||0.008
91691394|NCT03982511|183276793|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.36||0.5|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for pressure to eat scores from T2 to T1|effect size: -0.34|||0.50
91691395|NCT03982511|183276793|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.37||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for pressure to eat scores from T3 to T1|effect size: -0.01|||0.98
91527307|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.5|STANDARD_ERROR_OF_MEAN|7.052|||TWO_SIDED|95.0|1.74|31.26|||||Comparison of QTcB Day 7.|||31.26|1.74|
91722304|NCT04609553|183337072|SUPERIORITY|||||||0.82||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.82
91722305|NCT04609553|183337072|SUPERIORITY|||||||0.001||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.001
91722531|NCT02629159|183337899|SUPERIORITY||LS Mean Difference|1.62||||0.002|TWO_SIDED|95.0|0.62|2.62||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.62|0.62|0.002
91489298|NCT03345914|182851326|SUPERIORITY||Least Square Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.47|-20.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-20.82|-36.47|< 0.0001
91489299|NCT03345914|182851327|SUPERIORITY||Percentage difference|46.4|||<|0.0001|TWO_SIDED|95.0|35.3|57.42||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||57.42|35.3|< 0.0001
91527308|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|STANDARD_ERROR_OF_MEAN|8.908|||TWO_SIDED|95.0|-16.51|20.78|||||Comparison of QTcF Day 1.|||20.78|-16.51|
91527309|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.29|STANDARD_ERROR_OF_MEAN|5.298|||TWO_SIDED|95.0|1.2|23.38|||||Comparison of QTcF Day 7.|||23.38|1.20|
91527310|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.66|STANDARD_ERROR_OF_MEAN|9.171|||TWO_SIDED|95.0|-1.53|36.85|||||Comparison of QTcF Day 1.|||36.85|-1.53|
91722306|NCT04609553|183337072|SUPERIORITY|||||||0.16||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple, potentially highly correlated primary outcomes, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment across primary outcomes and timepoints within domain (total=3 outcomes within the language development). Right skewed variables with minimum values of zero were log-transformed after adding one. minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for child communicative development was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.16
91722307|NCT04609553|183337073|SUPERIORITY|||||||0.93||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.93
91722308|NCT04609553|183337073|SUPERIORITY|||||||0.04||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 9-month follow-up, A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.04
91691396|NCT03982511|183276794|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.32||0.17|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T2 to T1|effect size: -0.70|||0.17
91527311|NCT00453479|182929951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.32|STANDARD_ERROR_OF_MEAN|5.454|||TWO_SIDED|95.0|10.9|33.73|||||Comparison of QTcF Day 7.|||33.73|10.90|
91691397|NCT03982511|183276794|SUPERIORITY||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T3 to T1|effect size: -0.51|||0.34
91691398|NCT03982511|183276795|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T2 to T1|effect size: -0.06|||0.91
91691399|NCT03982511|183276795|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.22||0.45|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T3 to T1|effect size: -0.40|||0.45
91527312|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.55|STANDARD_ERROR_OF_MEAN|5.262|||TWO_SIDED|95.0|-1.46|20.57|||||Comparison of QTcB Day 1.|||20.57|-1.46|
91527313|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|5.902|||TWO_SIDED|95.0|-3.97|20.74|||||Comparison of QTcB Day 7.|||20.74|-3.97|
91691400|NCT03982511|183276796|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T2 to T1.|effect size: -1.12|||0.03
91691401|NCT03982511|183276796|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T3 to T1|effect size: -1.25|||0.03
91489300|NCT03345914|182851327|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|27.88|50.51||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.51|27.88|< 0.0001
91489301|NCT03345914|182851328|SUPERIORITY||Percentage difference|46.0|||<|0.0001|TWO_SIDED|95.0|35.47|56.61||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||56.61|35.47|< 0.0001
91691402|NCT03982511|183276797|SUPERIORITY||Mean Difference (Net)|2.23|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation from T2 to T1|effect size: 1.02|||0.05
91691403|NCT03982511|183276797|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.11|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation scores from T3 to T1|effect size: 0.88|||0.11
91691404|NCT03982511|183276798|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|1.0||0.002|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T2 to T1|effect size: 1.77|||0.002
91691405|NCT03982511|183276798|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T3 to T1|effect size: 0.63|||0.24
91691406|NCT03982511|183276799|SUPERIORITY||Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.05||0.53|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T2 to T1|effect size: 0.31|||0.53
91691407|NCT03982511|183276799|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T3 to T1|effect size: 0.15|||0.77
91691408|NCT03982511|183276800|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T2 to T1|effect size: 0.04|||0.91
91691409|NCT03982511|183276800|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|1.36||0.64|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T3 to T1|effect size: 0.17|||0.64
91691410|NCT03982511|183276800|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.34||0.31|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T2 to T1|effect size: -0.36|||0.31
91691411|NCT03982511|183276800|SUPERIORITY||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.39||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T3 to T1|effect size: -0.85|||0.04
91691412|NCT03982511|183276801|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T2 to T1|effect size: -1.25|||0.03
91691413|NCT03982511|183276801|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.1|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T3 to T1|effect size: -1.08|||0.10
91691414|NCT03982511|183276801|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T2 to T1|effect size: -0.44|||0.41
91691415|NCT03982511|183276801|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.21|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T3 to T1|effect size: -0.80|||0.21
91691416|NCT03982511|183276801|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T2 to T1|effect size: -1.29|||0.02
91489302|NCT03345914|182851328|SUPERIORITY||Percentage difference|38.5|||<|0.0001|TWO_SIDED|95.0|27.86|49.21||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||49.21|27.86|< 0.0001
91527314|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.47|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|95.0|-0.02|22.96|||||Comparison of QTcB Day 1.|||22.96|-0.02|
91691417|NCT03982511|183276801|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.2|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T3 to T1|effect size: -0.82|||0.20
91691418|NCT03982511|183276802|SUPERIORITY||Mean Difference (Net)|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.009|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T2 to T1|effect size: 1.55|||0.009
91691419|NCT03982511|183276802|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T3 to T1|effect size: -0.13|||0.84
91691420|NCT03982511|183276802|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T2 to T1|effect size: 0.63|||0.24
91691421|NCT03982511|183276802|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T3 to T1.|effect size: -0.13|||0.84
91691422|NCT03982511|183276803|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|2.17||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T2 to T1|effect size: -1.50|||0.00
91691423|NCT03982511|183276803|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|2.48||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T3 to T1|effect size: -1.12|||0.01
91691424|NCT03982511|183276804|SUPERIORITY||Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.63||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T2 to T1|effect size: -0.93|||0.02
91691425|NCT03982511|183276804|SUPERIORITY||Mean Difference (Net)|-6.58|STANDARD_ERROR_OF_MEAN|3.56||0.08|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T3 to T1|effect size: -0.68|||0.08
91691426|NCT03982511|183276804|SUPERIORITY||Mean Difference (Net)|-6.47|STANDARD_ERROR_OF_MEAN|6.92||0.36|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for adaptive skills from T2 to T1|effect size: -0.33|||0.36
91691427|NCT03982511|183276804|SUPERIORITY||Mean Difference (Net)|-3.57|STANDARD_ERROR_OF_MEAN|8.83||0.69|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for adaptive skills from T3 to T1|effect size: -0.15|||0.69
91691428|NCT03982511|183276805|SUPERIORITY||Mean Difference (Net)|35.78|STANDARD_ERROR_OF_MEAN|7.21||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T2 to T1 (higher scores indicate better outcomes).|effect size: 1.70|||0.000
91691429|NCT03982511|183276805|SUPERIORITY||Mean Difference (Net)|21.78|STANDARD_ERROR_OF_MEAN|7.64||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T3 to T1|effect size: 1.04|||0.01
91489303|NCT03345914|182851329|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|28.68|50.72||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.72|28.68|< 0.0001
91489304|NCT03345914|182851329|SUPERIORITY||Percentage difference|47.9|||<|0.0001|TWO_SIDED|95.0|37.77|58.01||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||58.01|37.77|< 0.0001
91527315|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.28|STANDARD_ERROR_OF_MEAN|6.157|||TWO_SIDED|95.0|2.39|28.17|||||Comparison of QTcB Day 7.|||28.17|2.39|
91691430|NCT03982511|183276806|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
91691431|NCT03982511|183276806|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures||Difference on difference for BMI z-scores from T3 to T1.|Effect size: -0.01|||.98
91691432|NCT00568451|183276809|SUPERIORITY_OR_OTHER||Median|12.5|||||ONE_SIDED|95.0|4.5||||Kaplan-Meier||||||4.5|
91691433|NCT01416636|183276854|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91691434|NCT01416636|183276854|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
91691435|NCT01416636|183276855|SUPERIORITY|||||||0.605|||||||Wilcoxon (Mann-Whitney)|||||||0.605
91691436|NCT01416636|183276856|SUPERIORITY|||||||0.307|||||||Wilcoxon (Mann-Whitney)|||||||0.307
91691437|NCT01416636|183276857|SUPERIORITY|||||||0.0019|||||||Chi-squared|||||||0.0019
91691438|NCT01416636|183276858|SUPERIORITY|||||||0.557|||||||Wilcoxon (Mann-Whitney)|||||||0.557
91691439|NCT01416636|183276859|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91691440|NCT01416636|183276860|SUPERIORITY|||||||1e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00001
91691441|NCT01416636|183276861|SUPERIORITY|||||||3e-06|||||||Wilcoxon (Mann-Whitney)|||||||0.000003
91691442|NCT01416636|183276862|SUPERIORITY|||||||8e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00008
91691443|NCT01416636|183276863|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91691444|NCT01416636|183276864|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
91691445|NCT00793455|183276875|SUPERIORITY_OR_OTHER||Rate Ratio|3.1|||<|0.05|TWO_SIDED|95.0|1.5|6.2|||Chi-squared|||We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value \< .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.||6.2|1.5|<0.05
91691446|NCT00793455|183276876|SUPERIORITY_OR_OTHER||Rate Ratio|1.5|||<|0.05|TWO_SIDED|95.0|1.03|2.2|||Chi-squared|||Same as primary outcome.||2.2|1.03|<0.05
91691447|NCT00699998|183276885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915||||0.21|TWO_SIDED|95.0|0.793|1.055||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.055|0.793|0.210
91691448|NCT00699998|183276885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.731|TWO_SIDED|95.0|0.865|1.225||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.225|0.865|0.731
91691449|NCT00699998|183276886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.388|TWO_SIDED|95.0|0.812|1.088|||Log Rank|Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.088|0.812|0.388
91691450|NCT00699998|183276886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.99|TWO_SIDED|95.0|0.833|1.195||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.195|0.833|0.990
91691451|NCT00699998|183276887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.353|TWO_SIDED|95.0|0.826|1.073||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.073|0.826|0.353
91691452|NCT00699998|183276887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.719|TWO_SIDED|95.0|0.869|1.218||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.218|0.869|0.719
91691453|NCT00699998|183276888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.27|TWO_SIDED|95.0|0.81|1.063||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.063|0.810|0.270
91691454|NCT00699998|183276888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.831|TWO_SIDED|95.0|0.862|1.2||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.200|0.862|0.831
91691455|NCT00699998|183276889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.208|||<|0.001|TWO_SIDED|95.0|-107.872|-92.545||p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for Day 30 comparison|||-92.545|-107.872|<0.001
91691456|NCT00699998|183276889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-104.475|||<|0.001|TWO_SIDED|95.0|-115.383|-93.566||p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for 12 month comparison.|||-93.566|-115.383|<0.001
91691457|NCT00699998|183276889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.413|||<|0.001|TWO_SIDED|95.0|-63.718|-33.108||p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 30 day comparison.|||-33.108|-63.718|<0.001
91691458|NCT00699998|183276889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.264|||<|0.001|TWO_SIDED|95.0|-69.061|-23.468||p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 12 month comparison.|||-23.468|-69.061|<0.001
91691459|NCT00699998|183276890|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|0.982||||0.631|TWO_SIDED|95.0|0.91|1.059||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.059|0.910|0.631
91691460|NCT00699998|183276890|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.01||||0.844|TWO_SIDED|95.0|0.916|1.113||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.113|0.916|0.844
91691461|NCT00699998|183276890|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.138||||0.098|TWO_SIDED|95.0|0.977|1.325||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.325|0.977|0.098
91691462|NCT00699998|183276890|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.066||||0.545|TWO_SIDED|95.0|0.867|1.31||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.310|0.867|0.545
91691463|NCT00699998|183276891|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.018||||0.727|TWO_SIDED|95.0|0.919|1.129||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.129|0.919|0.727
91691464|NCT00699998|183276891|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.057||||0.346|TWO_SIDED|95.0|0.942|1.187||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.187|0.942|0.346
91691465|NCT00699998|183276891|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.096||||0.458|TWO_SIDED|95.0|0.859|1.399||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.399|0.859|0.458
91691466|NCT00699998|183276891|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.033||||0.802|TWO_SIDED|95.0|0.803|1.329||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.329|0.803|0.802
91722309|NCT04609553|183337073|SUPERIORITY|||||||0.08||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.08
91722310|NCT04609553|183337073|SUPERIORITY|||||||0.03||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the social emotional domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=2 outcomes within the social emotional). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects for both active treatments versus control. The adjusted value for social emotional development was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.03
91722311|NCT04609553|183337074|SUPERIORITY|||||||0.002||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Reading Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.002
91722312|NCT04609553|183337074|SUPERIORITY|||||||0.8||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Reading Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.80
91722532|NCT02629159|183337900|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|26.5|35.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.8|26.5|<0.001
91722313|NCT04609553|183337074|SUPERIORITY|||||||0.79||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Reading Scale at the18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.79
91722314|NCT04609553|183337074|SUPERIORITY|||||||0.96||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Reading Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for reading activities was the value of the outcome minus the effect of baseline and the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and both treatment and baseline fixed effects.|||0.96
91722315|NCT04609553|183337074|SUPERIORITY|||||||0.22||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Parent Verbal Responsiveness Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.22
91722316|NCT04609553|183337074|SUPERIORITY||||||<|0.001||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Parent Verbal Responsiveness Scale at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||<0.001
91489305|NCT03345914|182851330|SUPERIORITY||Percentage difference|23.0|||<|0.0001|TWO_SIDED|95.0|13.65|32.38||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||32.38|13.65|< 0.0001
91489306|NCT03345914|182851330|SUPERIORITY||Percentage difference|34.5|||<|0.0001|TWO_SIDED|95.0|24.6|44.37||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||44.37|24.6|< 0.0001
91489307|NCT03345914|182851331|SUPERIORITY||Hazard ratios|3.114|||<|0.0001|TWO_SIDED|95.0|2.097|4.624||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.624|2.097|< 0.0001
91527316|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.32|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-1.35|18.0|||||Comparison of QTcF Day 1.|||18.00|-1.35|
91691467|NCT00699998|183276893|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.5
91489308|NCT03345914|182851331|SUPERIORITY||Hazard ratios|2.921|||<|0.0001|TWO_SIDED|95.0|1.957|4.36||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.36|1.957|< 0.0001
91527317|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.239|||TWO_SIDED|95.0|-2.21|19.72|||||Comparison of QTcF Day 7.|||19.72|-2.21|
91527318|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.83|STANDARD_ERROR_OF_MEAN|4.759|||TWO_SIDED|95.0|6.87|26.79|||||Comparison of QTcF Day 1.|||26.79|6.87|
91691468|NCT00699998|183276893|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.72
91691469|NCT00699998|183276893|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.63
91691470|NCT00699998|183276893|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.53
91691471|NCT04616612|183276901|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
91691472|NCT04616612|183276902|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||.04
91691473|NCT04616612|183276903|OTHER||||||||||||||||||"Qualitative data evaluated from interviews tailored after the acceptability scale questionnaire. These interview questions specifically asked participant to rate from strongly disagree to strongly agree on each question and then rationalize answers.~Mobile support: 77% of participants agreed that mobile messages supported their health behaviors.~Time required: 85% disagreed that the intervention took too much time to learn.~Program effectiveness: 92% enjoyed this learning approach, with 100% agreeing they could use the information to improve health behaviors.~Rationalization feedback found participants in rural areas reported difficulties accessing texts."|||
91691474|NCT04616612|183276904|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91691475|NCT04616612|183276905|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91691476|NCT04616612|183276906|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
91691477|NCT04616612|183276907|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
91691478|NCT04616612|183276908|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||.84
91691479|NCT04616612|183276909|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
91691480|NCT01451463|183276911|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||||||.009
91527319|NCT00453479|182929952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.46|STANDARD_ERROR_OF_MEAN|5.394|||TWO_SIDED|95.0|9.17|31.75|||||Comparison of QTcF Day 7.|||31.75|9.17|
91527320|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.035|0.328|||||Comparison of FEV1, Day 1, 1 hour|||0.328|-0.035|
91691481|NCT01451463|183276912|SUPERIORITY_OR_OTHER|||||||0.114|||||||t-test, 2 sided|||||||.114
91691482|NCT04740918|183276913|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (estrogen receptors (ER) and/or progesterone receptor (PgR) positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the Hazard Ratio (HR).|Hazard Ratio (HR)|0.75||||0.2876|TWO_SIDED|95.0|0.44|1.28|||Log Rank|||||1.28|0.44|0.2876
91691483|NCT04740918|183276914|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.59||||0.5151|TWO_SIDED|95.0|0.39|6.43|||Log Rank|||||6.43|0.39|0.5151
91691484|NCT04740918|183276915|SUPERIORITY|A Cochran-Mantel-Haenszel chi-square test, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis), was used to test for difference in response rates.|Odds Ratio (OR)|1.16||||0.724|TWO_SIDED|95.0|0.5|2.7|||Cochran-Mantel-Haenszel|||||2.70|0.50|0.7240
91722317|NCT04609553|183337074|SUPERIORITY|||||||0.96||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Parent Verbal Responsiveness Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.96
91722318|NCT04609553|183337074|SUPERIORITY|||||||0.12||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||Analysis for the Parent Verbal Responsiveness Scale at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. The adjusted value for verbal responsiveness was the value of the outcome minus the best linear unbiased predictor (BLUP) estimated from a mixed linear model with random individual-specific intercepts and treatment fixed effects.|||0.12
91489309|NCT03345914|182851332|SUPERIORITY||Hazard ratios|2.278|||<|0.0001|TWO_SIDED|95.0|1.631|3.182||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||3.182|1.631|< 0.0001
91722319|NCT04609553|183337075|SUPERIORITY|||||||0.78||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Dialogic reading behavior was measured at a single timepoint (9 months), so no adjustment was necessary.|||0.78
91722533|NCT02629159|183337900|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Response Rate Difference|16.3|||||TWO_SIDED|95.0|10.0|22.5|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.5|10.0|
91722534|NCT02629159|183337900|SUPERIORITY||||||<|0.001||||||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use||||||<0.001
91489310|NCT03345914|182851332|SUPERIORITY||Hazard ratios|2.075|||<|0.0001|TWO_SIDED|95.0|1.481|2.908||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.908|1.481|< 0.0001
91527321|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171|STANDARD_ERROR_OF_MEAN|0.0944|||TWO_SIDED|95.0|-0.015|0.357|||||Comparison of FEV1, Day 1, 2 hour|||0.357|-0.015|
91527322|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.107|0.228|||||Comparison of FEV1, Day 1, 4 hour|||0.228|-0.107|
91527323|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1195|||TWO_SIDED|95.0|-0.085|0.386|||||Comparison of FEV1, Day 1, 9 hour|||0.386|-0.085|
91527324|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.1107|||TWO_SIDED|95.0|-0.094|0.343|||||Comparison of FEV1, Day 1, 12 hour|||0.343|-0.094|
91527325|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.077|0.404|||||Comparison of FEV1, Day 1, 24 hour|||0.404|-0.077|
91527326|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.236|STANDARD_ERROR_OF_MEAN|0.1057|||TWO_SIDED|95.0|0.027|0.444|||||Comparison of FEV1, Day 7, Baseline|||0.444|0.027|
91722320|NCT04609553|183337075|SUPERIORITY|||||||0.96||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Dialogic reading behavior was measured at a single timepoint (9 months), so no adjustment was necessary.|||0.96
91722321|NCT04609553|183337076|SUPERIORITY|||||||0.78||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Discipline strategies were measured at a single timepoint (18 months), so no adjustment was necessary.|||0.78
91722322|NCT04609553|183337076|SUPERIORITY|||||||0.96||||||p-value is adjusted using the minP approach for potentially highly correlated outcomes. Then, p \< 0.05 was used as an a priori threshold for statistical significance.|ANOVA|||A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.|We followed the intent to treat principle, with participants included based on their group assignment. Because of the multiple correlated timepoints within the parental behavior domain, we used the step-down minP method (a re-sampling approach), to assess the effects of treatment (total=6 outcomes within the parental behavior). minP-adjusted p-values were calculated with ANOVA models comparing outcomes adjusted for baseline- and correlations due to repeated-measure effects (as appropriate) for both active treatments versus control. Discipline strategies were measured at a single timepoint (18 months), so no adjustment was necessary.|||0.96
91722323|NCT04609553|183337077|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.80
91722324|NCT04609553|183337077|SUPERIORITY|||||||0.06||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.06
91722325|NCT04609553|183337077|SUPERIORITY|||||||0.81||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||"Analysis at the 18-month follow-up.~\\A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2."||||0.81
91722326|NCT04609553|183337077|SUPERIORITY|||||||0.08||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.08
91722327|NCT04609553|183337078|SUPERIORITY|||||||0.07||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.07
91722328|NCT04609553|183337078|SUPERIORITY|||||||0.91||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.91
91722329|NCT04609553|183337078|SUPERIORITY|||||||0.39||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.39
91489311|NCT03345914|182851333|SUPERIORITY||Least Square Mean Difference|-17.72|||<|0.0001|TWO_SIDED|95.0|-22.272|-13.161||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-13.161|-22.272|< 0.0001
91527327|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.1292|||TWO_SIDED|95.0|-0.026|0.483|||||Comparison of FEV1, Day 7, 1 hour|||0.483|-0.026|
91527328|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.163|0.353|||||Comparison of FEV1, Day 7, 2 hour|||0.353|-0.163|
91527329|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173|STANDARD_ERROR_OF_MEAN|0.1243|||TWO_SIDED|95.0|-0.072|0.418|||||Comparison of FEV1, Day 7, 4 hour|||0.418|-0.072|
91489312|NCT03345914|182851333|SUPERIORITY||Least Square Mean Difference|-18.88|||<|0.0001|TWO_SIDED|95.0|-23.479|-14.289||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-14.289|-23.479|< 0.0001
91489313|NCT03345914|182851334|SUPERIORITY||Least Square Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.3|-24.48||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-24.48|-36.3|< 0.0001
91691485|NCT04740918|183276916|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|0.65||||0.3531|TWO_SIDED|95.0|0.26|1.61|||Log Rank|||||1.61|0.26|0.3531
91722330|NCT04609553|183337078|SUPERIORITY|||||||0.1||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||"Analysis at the 18-month follow-up.~\\A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3."||||0.10
91722331|NCT04609553|183337079|SUPERIORITY|||||||0.19||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.19
91722332|NCT04609553|183337079|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.18
91489314|NCT03345914|182851334|SUPERIORITY||Least Square Mean Difference|-32.6|||<|0.0001|TWO_SIDED|95.0|-38.57|-26.59||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.59|-38.57|< 0.0001
91489315|NCT03345914|182851335|SUPERIORITY||Least Square Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.62|-2.99||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.99|-5.62|< 0.0001
91489316|NCT03345914|182851335|SUPERIORITY||Least Square Mean Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.89||The confidence interval (CI) with p-value was based on treatment difference (dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.89|-5.57|< 0.0001
91691486|NCT04740918|183276917|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.35||||0.7175|TWO_SIDED|95.0|0.27|6.81|||Log Rank|||||6.81|0.27|0.7175
91722333|NCT04609553|183337079|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.18
91722334|NCT04609553|183337079|SUPERIORITY|||||||0.45||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.45
91722335|NCT04609553|183337080|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||<.001
91722336|NCT04609553|183337080|SUPERIORITY|||||||0.68||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.68
91489317|NCT03345914|182851336|SUPERIORITY||Least Square Mean Difference|-8.1|||<|0.0001|TWO_SIDED|95.0|-9.96|-6.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.31|-9.96|< 0.0001
91527330|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.205|STANDARD_ERROR_OF_MEAN|0.1499|||TWO_SIDED|95.0|-0.09|0.501|||||Comparison of FEV1, Day 7, 9 hour|||0.501|-0.090|
91691487|NCT04740918|183276918|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.||||||0.3173|||||||Log Rank|||||||0.3173
91691488|NCT04740918|183276919|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.19||||0.8658|TWO_SIDED|95.0|0.16|8.6|||Log Rank|||||8.60|0.16|0.8658
91691489|NCT04740918|183276920|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.16||||0.8407|TWO_SIDED|95.0|0.27|4.99|||Log Rank|||||4.99|0.27|0.8407
91691490|NCT01609790|183276962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Z-test|One-sided test, significance level 0.15||Assuming a 36% 6-month (6m) rate in the placebo arm \[from the March 2009 Food and Drug Administration (FDA) briefing\], a 55% rate in the AMG 386 arm, and an exponential distribution corresponds to median PFS of 4.1 and 7 months, respectively, with a hazard ratio of 0.59 (AMG 386 arm vs. placebo arm). A total of 114 patients (57 per arm) will yield 85% power to detect an absolute 19% difference of 6m PFS rate at a 1-sided alpha level of 0.15 based on a 2-sample proportion test.||||0.98
91691491|NCT01609790|183276963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Chi-squared|||||||0.85
91691492|NCT01609790|183276964|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.09|TWO_SIDED|95.0|0.95|2.27|||Log Rank|||||2.27|0.95|0.09
91691493|NCT01609790|183276965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.51||||0.04|TWO_SIDED|95.0|1.02|2.24|||Log Rank|||||2.24|1.02|0.04
91691494|NCT01609790|183276966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||||||0.7
91691495|NCT01102257|183277001|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91691496|NCT05344560|183277019|NON_INFERIORITY|A non-inferiority margin of -5 points was used.|Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|2.018|||TWO_SIDED|95.0|-6.92|1.07|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test \[senofilcon A (C3) HEV chromophore\] minus Control \[senofilcon A (C3)\]|||1.07|-6.92|
91691497|NCT01051960|183277046|OTHER|comparison of means|Mean Difference (Final Values)|-93.0||||0.0008|TWO_SIDED|||||significant at p\<0.05|t-test, 2 sided|||Whether change from baseline to 24-weeks is significantly different from zero||||.0008
91691498|NCT01051960|183277047|OTHER||Mean Difference (Final Values)|44.5||||7e-05|TWO_SIDED||||||t-test, 2 sided|||change from baseline to 24 weeks||||0.00007
91691499|NCT02996968|183277051|NON_INFERIORITY|"Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.~A sample size was calculated to be 74 patients in each arm based on the following:~* The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%~* The non-inferiority margin was set at 15%.~* The power was set at 80%"|Proportion Difference|0.002||||0.5|ONE_SIDED|95.0||0.095||2-sample test for equality of proportions with continuity correction|Two proportions Z-test|||||0.095||0.5
91691500|NCT00607620|183277060|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
91691501|NCT00607620|183277061|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3|||||The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.|||-0.3|-2.1|
91691502|NCT00607620|183277062|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|0.4|6.4|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||6.4|0.4|
91691503|NCT00607620|183277063|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.3|1.9|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||1.9|-3.3|
91691504|NCT00607620|183277064|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-1.02|0.99|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||0.99|-1.02|
91691505|NCT00791778|183277065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.655|TWO_SIDED|95.0|0.72|1.63|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.||1.63|0.72|0.655
91691506|NCT00791778|183277066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.951|TWO_SIDED|95.0|0.93|2.2|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|||2.20|0.93|0.951
91691507|NCT00791778|183277067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.84|TWO_SIDED|95.0|0.69|3.23|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization.|Sorafenib compared to Placebo|||3.23|0.69|0.84
91691508|NCT01169064|183277117|SUPERIORITY_OR_OTHER|||||||0.365|||||||Chi-squared|||||||.365
91691509|NCT01169064|183277118|SUPERIORITY|||||||0.282|||||||Mixed Models Analysis|||||||.282
91691510|NCT03810092|183277170|OTHER||Odds Ratio, log|-0.04||||0.05|TWO_SIDED|95.0|-0.55|0.42|||Regression, Linear|||Relationship between ADL score evolution and hemoglobine rate, in the no transfusion group||0.42|-0.55|0.05
91691511|NCT03810092|183277170|OTHER||Odds Ratio, log|0.39||||0.05|TWO_SIDED|95.0|-1.0|2.2|||Regression, Logistic|||Relationship between ADL score evolution and hemoglobine rate, in the transfusion group||2.2|-1|0.05
91691512|NCT00235755|183277178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
91691513|NCT00235755|183277178|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||0.007
91691514|NCT00235755|183277179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91691515|NCT00235755|183277179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91691516|NCT02816736|183277198|SUPERIORITY||ratio of the AUCs|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Regression, Linear|||AUC was normalized for time; With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline.||1.08|0.84|0.45
91691517|NCT02816736|183277199|SUPERIORITY||Mean Difference (Net)|-11.22||||0.15|TWO_SIDED|95.0|-26.4|3.97|||general linear model|||||3.97|-26.4|0.15
91691518|NCT02816736|183277200|SUPERIORITY||Odds Ratio (OR)|1.14||||0.51|TWO_SIDED|95.0|0.78|1.68|||ordinal logistic regression|||||1.68|0.78|0.51
91691519|NCT02816736|183277201|SUPERIORITY||Odds Ratio (OR)|1.55||||0.16|TWO_SIDED|95.0|0.84|2.87|||Regression, Logistic|||||2.87|0.84|0.16
91691520|NCT02816736|183277202|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.34|2.91|||Regression, Logistic|||||2.91|0.34|0.99
91691521|NCT02816736|183277203|SUPERIORITY||Odds Ratio (OR)|2.05||||0.035|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.035
91691522|NCT00806403|183277225|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.||||0.56
91691523|NCT00806403|183277226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91691524|NCT00806403|183277227|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.||||0.04
91691525|NCT00806403|183277228|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.50
91691526|NCT00806403|183277229|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||||||0.21
91691527|NCT01320293|183277230|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
91691528|NCT01320293|183277231|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
91722337|NCT04609553|183337080|SUPERIORITY|||||||0.16||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.16
91691529|NCT01320293|183277232|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||0.05
91691530|NCT01532934|183277238|SUPERIORITY_OR_OTHER|||||||0.02||||||As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.|Regression, Linear|||A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.||||.02
91691531|NCT01532934|183277239|SUPERIORITY_OR_OTHER|||||||0.34||||||As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p\<.05.|Regression, Linear|||Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.||||.34
91691532|NCT01532934|183277240|SUPERIORITY_OR_OTHER|||||||0.69||||||a priori threshold p\<.05|Regression, Logistic|||Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.||||.69
91691533|NCT03759392|183277270|SUPERIORITY||Least squares mean difference|-0.447|STANDARD_ERROR_OF_MEAN|0.2931||0.13|TWO_SIDED|95.0|-1.024|0.131|||ANCOVA|Using multiple imputation||||0.131|-1.024|0.13
91691534|NCT03759392|183277271|SUPERIORITY||Least squares mean difference|-5.388|STANDARD_ERROR_OF_MEAN|2.3937||0.025|TWO_SIDED|95.0|-10.108|-0.0668|||ANCOVA|Using multiple imputation||||-0.0668|-10.108|0.025
91691535|NCT03759392|183277272|SUPERIORITY||Least squares mean difference|0.414|STANDARD_ERROR_OF_MEAN|0.6215||0.51|TWO_SIDED|95.0|-0.81|1.639|||ANCOVA|Using multiple imputation||||1.639|-0.810|0.51
91691536|NCT03759392|183277273|SUPERIORITY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.42||0.54|TWO_SIDED|95.0|-0.6|1.1|||Repeated measures mixed model|||||1.1|-0.6|0.54
91691537|NCT01288079|183277274|SUPERIORITY_OR_OTHER||LS mean|-1.5|STANDARD_ERROR_OF_MEAN|2.95||0.617|TWO_SIDED|95.0|-7.35|4.39|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||4.39|-7.35|0.617
91489318|NCT03345914|182851336|SUPERIORITY||Least Square Mean Difference|-8.3|||<|0.0001|TWO_SIDED|95.0|-10.13|-6.43||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.43|-10.13|< 0.0001
91691538|NCT01288079|183277274|SUPERIORITY_OR_OTHER||LS mean|-3.6|STANDARD_ERROR_OF_MEAN|3.26||0.277|TWO_SIDED|95.0|-10.06|2.91|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.91|-10.06|0.277
91691539|NCT01288079|183277274|SUPERIORITY_OR_OTHER||LS mean|-3.9|STANDARD_ERROR_OF_MEAN|2.95||0.194|TWO_SIDED|95.0|-9.72|2.0|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.00|-9.72|0.194
91691540|NCT03170544|183277278|OTHER||Mean|1.33|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.63|2.04|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|2.04|0.63|
91691541|NCT03170544|183277278|OTHER||Mean|2.74|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|2.03|3.44|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|3.44|2.03|
91691542|NCT02387840|183277303|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.0002
91691543|NCT02387840|183277303|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.0003
91691544|NCT02387840|183277304|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.081
91691545|NCT02387840|183277304|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.081
91691546|NCT02387840|183277305|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.12
91691547|NCT02387840|183277305|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.14
91691548|NCT01213966|183277307|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||PPR24 was summarized descriptively. No statistical test was performed. The PRR24 values were summarised when the corresponding regression fit had a p-value of p ≤0.01 and an adjusted coefficient of determination (R2) ≥0.85.|Regression, Linear|||PPR24 was summarised descriptively. No statistical test was performed.||||0.01
91691549|NCT03888469|183277321|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.0|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Moist|||0.00||
91691550|NCT00420420|183277368|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.283
91691551|NCT00420420|183277369|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at week 4||||0.180
91691552|NCT00420420|183277370|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.716
91691553|NCT00273182|183277374|SUPERIORITY_OR_OTHER||Overall survival rate at 36 month|71.0|||||TWO_SIDED|95.0|68.6|73.2||No p values for the analysis.|Kaplan-Meier (product limit) estimates|Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates.|The estimate is the overall survival rate at 36 month. left-truncation methods were used in the survival analysis for previously implanted subjects.|For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.||73.2|68.6|
91691554|NCT00273182|183277374|SUPERIORITY_OR_OTHER||Cause specific survival rate at 36 month|85.3|||||TWO_SIDED|95.0|83.3|87.1||No p value for this analysis.|Kaplan-Meier (product limit) estimates|Cause specific survival rate at 36 month.|left-truncation methods were used in the survival analysis for previously implanted subjects.|For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.||87.1|83.3|
91722338|NCT04609553|183337080|SUPERIORITY|||||||0.39||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.39
91691555|NCT00273182|183277378|SUPERIORITY_OR_OTHER||event free rate|89.8|||||TWO_SIDED|95.0|88.3|91.2||No p value for this analysis.|Kaplan-Meier (product limit) estimate|||Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.||91.2|88.3|
91691556|NCT02996227|183277389|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Mean Difference (Final Values)|0.09|||<|0.001|TWO_SIDED|95.2|-0.12|0.3|||Mixed Models Analysis|||||0.30|-0.12|<0.001
91691557|NCT02996227|183277390|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Ratio of Geometric means|1.37||||0.754|TWO_SIDED|95.2|1.05|1.79|||Mixed Models Analysis|||||1.79|1.05|0.754
91691558|NCT02996227|183277391|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|99.0|0.53|2.76|||Regression, Linear|linear regression after logarithm transformation||||2.76|0.53|0.560
91691559|NCT02996227|183277392|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.357|TWO_SIDED|99.0|-0.65|1.37|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure|||1.37|-0.65|0.357
91691560|NCT02996227|183277393|SUPERIORITY||Risk Ratio (RR)|0.64||||0.006|TWO_SIDED|99.0|0.42|0.98|||generalized linear regression|||||0.98|0.42|0.006
91691561|NCT02996227|183277394|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.695|TWO_SIDED|99.0|-4.31|5.85|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure.|||5.85|-4.31|0.695
91691562|NCT02996227|183277395|SUPERIORITY||Ratio of geometric means|0.98||||0.738|TWO_SIDED|99.0|0.86|1.12|||Regression, Linear|linear regression after logarithmic transformation||||1.12|0.86|0.738
91691563|NCT01100086|183277402|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|99.35|105.42|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||105.42|99.35|
91691564|NCT01100086|183277403|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.0|||||TWO_SIDED|90.0|94.94|101.19|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.19|94.94|
91691565|NCT01100086|183277404|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
91691566|NCT01100086|183277404|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
91722339|NCT04609553|183337081|SUPERIORITY|||||||0.87||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.87
91527331|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.062|0.502|||||Comparison of FEV1, Day 7, 12 hour|||0.502|-0.062|
91489319|NCT03345914|182851337|SUPERIORITY||Least Square Mean Difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.984|-1.831||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.831|-2.984|< 0.0001
91489320|NCT03345914|182851337|SUPERIORITY||Least Square Mean Difference|-2.18|||<|0.0001|TWO_SIDED|95.0|-2.754|-1.599||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.599|-2.754|< 0.0001
91489321|NCT03345914|182851338|SUPERIORITY||Least Square Mean Difference|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.434|-2.796||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.796|-5.434|< 0.0001
91489322|NCT03345914|182851338|SUPERIORITY||Least Square Mean Difference|-3.98|||<|0.0001|TWO_SIDED|95.0|-5.298|-2.657||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.657|-5.298|< 0.0001
91489323|NCT03345914|182851339|SUPERIORITY||Least Square Mean Difference|-3.37|||=|0.0061|TWO_SIDED|95.0|-5.779|-0.962||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.962|-5.779|= 0.0061
91489324|NCT03345914|182851339|SUPERIORITY||Least Square Mean Difference|-3.02|||=|0.0133|TWO_SIDED|95.0|-5.414|-0.629||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.629|-5.414|= 0.0133
91489325|NCT03345914|182851340|SUPERIORITY||Least Square Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.734|-2.272||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.272|-6.734|< 0.0001
91527332|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.093|0.506|||||Comparison of FEV1, Day 7, 24 hour|||0.506|-0.093|
91527333|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|0.015|0.397|||||Comparison of FEV1, Day 1, 1 hour|||0.397|0.015|
91691567|NCT04227197|183277415|SUPERIORITY|The p value compares the trend in the number of indicated or completed evaluations in the Intervention arm versus Control arm.||||||0.018|||||||Cochran-Armitage trend test|Two tailed; no continuity correction||||||0.018
91691568|NCT04227197|183277417|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group.||||||0.468|||||||ANOVA|||This is the p value for the PedsQL Psychosocial Health Score||||0.468
91691569|NCT04227197|183277417|SUPERIORITY|||||||0.802|||||||ANOVA|||This p value is for the PedsQL Physical Functioning Score||||0.802
91691570|NCT04227197|183277417|SUPERIORITY|||||||0.761|||||||ANOVA|||This is the p value for the PedsQL Total Scale Score||||0.761
91691571|NCT04227197|183277417|SUPERIORITY|||||||0.965|||||||ANOVA|||This is the p value for the PedsQL FIM Parental HRQL Summary Score||||0.965
91691572|NCT04227197|183277417|SUPERIORITY|||||||0.619|||||||ANOVA|||This is the p value for the PedsQL FIM Family Functioning Summary Score||||0.619
91691573|NCT04227197|183277417|SUPERIORITY|||||||0.469|||||||ANOVA|||This is the p value for the PedsQL FIM Total Scale Score||||0.469
91691574|NCT04227197|183277418|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.068|||||||ANOVA|||This is for the change from baseline on PedsQL Psychosocial Health Score||||0.068
91489326|NCT03345914|182851340|SUPERIORITY||Least Square Mean Difference|-5.42|||<|0.0001|TWO_SIDED|95.0|-7.641|-3.207||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-3.207|-7.641|< 0.0001
91489327|NCT03345914|182851341|SUPERIORITY||Percentage Differenece|-4.8|||=|0.222|TWO_SIDED|95.0|-12.49|2.87||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.87|-12.49|= 0.222
91489328|NCT03345914|182851341|SUPERIORITY||Percentage Differenece|-7.3|||=|0.0508|TWO_SIDED|95.0|-14.51|-0.03||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.03|-14.51|= 0.0508
91527334|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.0994|||TWO_SIDED|95.0|0.133|0.525|||||Comparison of FEV1, Day 1, 2 hour|||0.525|0.133|
91489329|NCT03345914|182851344|SUPERIORITY||Least Square Mean Difference|-5.7|||=|0.003|TWO_SIDED|95.0|-9.49|-1.96||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level||-1.96|-9.49|= 0.003
91527335|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.0895|||TWO_SIDED|95.0|0.09|0.443|||||Comparison of FEV1, Day 1, 4 hour|||0.443|0.090|
91691575|NCT04227197|183277418|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.907|||||||ANOVA|||This is for the change from baseline for PedsQL Physical Functioning Score||||0.907
91691576|NCT04227197|183277418|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.196|||||||ANOVA|||This is for the change from baseline for PedsQL Total Scale Score||||0.196
91691577|NCT04227197|183277418|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.112|||||||ANOVA|||This is for the change from baseline for PedsQL FIM Parental HRQL Summary Score||||0.112
91691578|NCT04227197|183277418|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.245|||||||ANOVA|||This is for change from baseline for PedsQL FIM Family Functioning Summary Score||||0.245
91691579|NCT04227197|183277418|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.219|||||||ANOVA|||This is for change from baseline for PedsQL FIM Total Scale Score||||0.219
91691580|NCT02992236|183277424|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91691581|NCT02549859|183277427|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91691582|NCT02549859|183277428|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
91691583|NCT02549859|183277429|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
91691584|NCT02549859|183277430|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691585|NCT02549859|183277431|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91527336|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.1258|||TWO_SIDED|95.0|0.072|0.568|||||Comparison of FEV1, Day 1, 9 hour|||0.568|0.072|
91691586|NCT02549859|183277432|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691587|NCT02549859|183277433|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691588|NCT02549859|183277434|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
91691589|NCT02549859|183277435|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91691590|NCT02549859|183277436|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691591|NCT02549859|183277437|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
91691592|NCT02549859|183277438|SUPERIORITY||||||<|0.001|||||||Paired t-test, 2 sided|||||||<0.001
91691593|NCT02549859|183277439|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91691594|NCT02549859|183277440|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691595|NCT02549859|183277441|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691596|NCT02549859|183277442|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91691597|NCT02549859|183277443|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91691598|NCT02549859|183277444|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
91691599|NCT02549859|183277445|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91489330|NCT03345914|182851344|SUPERIORITY|A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level|Least Square Mean Difference|-5.1|||=|0.0082|TWO_SIDED|95.0|-8.8|-1.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||||-1.31|-8.8|= 0.0082
91489331|NCT02218320|182851370|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91527337|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.172|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|95.0|-0.058|0.402|||||Comparison of FEV1, Day 1, 12 hour|||0.402|-0.058|
91527338|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.099|0.407|||||Comparison of FEV1, Day 1, 24 hour|||0.407|-0.099|
91527339|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.1113|||TWO_SIDED|95.0|0.036|0.475|||||Comparison of FEV1, Day 7, Baseline|||0.475|0.036|
91691600|NCT02549859|183277446|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
91691601|NCT03446027|183277447|OTHER|"Prespecified Tobit Regression mode: the model included the AWD baseline measurement, a treatment indicator and the type of centre (SET versus non-SET) as covariates. As the data collected for AWD showed a right-skewed distribution, a square root transformation was used to normalise the data and used for the regression Tobit model. This resulted in the unit of measure being units rather than meters."|square root transformation|0.835||||0.28|TWO_SIDED|95.0|-0.674|2.343|||Tobit Regression|||"Right censored Tobit regression model for AWD at 3 months for the ITT population.~Difference between arms (between baseline and 3 months) - the primary analysis estimates the difference in the AWD at 3 months between the two treatment groups control vs. device. Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET Included participants with both baseline and 3 month treadmill data."||2.343|-0.674|0.28
91691602|NCT03446027|183277448|OTHER|"Right censored, Tobit Regression model to assess the effects of baseline characteristics for ICD at 3 months for the ITT Population. This resulted in the unit of measure being units and not meters.~Included participants with both baseline and 3 month treadmill data. Calculation between arms - estimates the difference in the ICD at 3 months between the two treatment groups.~Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET"|square root transformation|0.972||||0.23|TWO_SIDED|95.0|-0.6|2.546|||Right censored, Tobit Regression|||||2.546|-0.600|0.23
91691603|NCT03446027|183277452|OTHER|"Linear Regression Model for Duplex ultrasonography (Volume flow - measured in one leg) at 3 months for the ITT population.~Difference (calculation) between the two groups and not per arm (control vs treatment). Unit of measure is Units due to the use of a linear regression model rather than cc/min."|Linear regression|0.483||||0.516|TWO_SIDED|95.0|-0.984|1.95|||Regression, Linear|||||1.950|-0.984|0.516
91691604|NCT00708552|183277502|SUPERIORITY||Mean Difference (Net)|1.1||||0.159|TWO_SIDED|95.0|-0.4|2.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 24||2.7|-0.4|0.159
91691605|NCT00708552|183277502|SUPERIORITY||Mean Difference (Net)|0.7||||0.41|TWO_SIDED|95.0|-0.9|2.3|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 24||2.3|-0.9|0.410
91691606|NCT00708552|183277502|SUPERIORITY||Mean Difference (Net)|-0.2||||0.821|TWO_SIDED|95.0|-1.6|1.2|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepezil at Week 24||1.2|-1.6|0.821
91691607|NCT00708552|183277503|SUPERIORITY||Mean Difference (Net)|0.2||||0.254|TWO_SIDED|95.0|-0.1|0.5|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.1|0.254
91691608|NCT00708552|183277503|SUPERIORITY||Mean Difference (Net)|-0.1||||0.394|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.4|0.394
91489332|NCT00885846|182851379|NON_INFERIORITY_OR_EQUIVALENCE|Regression analysis performed for equal variance at baseline.||||||0.664||95.0|||||Repeated ANOVA|degrees of freedom = 2||Power analysis suggested 27 participants, 9 in each group.||||0.664
91489333|NCT00074984|182851380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.1449|TWO_SIDED|95.0|0.269|1.222|||Log Rank|Comparison is based on a 2-sided log-rank test.||||1.222|0.269|0.1449
91527340|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.296|STANDARD_ERROR_OF_MEAN|0.1361|||TWO_SIDED|95.0|0.027|0.564|||||Comparison of FEV1, Day 7, 1 hour|||0.564|0.027|
91527341|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.202|STANDARD_ERROR_OF_MEAN|0.1378|||TWO_SIDED|95.0|-0.069|0.474|||||Comparison of FEV1, Day 7, 2 hour|||0.474|-0.069|
91527342|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.207|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.051|0.465|||||Comparison of FEV1, Day 7, 4 hour|||0.465|-0.051|
91527343|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.1579|||TWO_SIDED|95.0|-0.032|0.591|||||Comparison of FEV1, Day 7, 9 hour|||0.591|-0.032|
91691609|NCT00708552|183277503|SUPERIORITY||Mean Difference (Net)|-0.3||||0.049|TWO_SIDED|95.0|-0.6|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepezil at Week 24||-0.0|-0.6|0.049
91691610|NCT00708552|183277504|SUPERIORITY||Mean Difference (Net)|-1.6||||0.423|TWO_SIDED|95.0|-5.6|2.3|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-15mg at Week 24||2.3|-5.6|0.423
91691611|NCT00708552|183277504|SUPERIORITY||Mean Difference (Net)|-2.1||||0.305|TWO_SIDED|95.0|-6.1|1.9|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-35mg at Week 24||1.9|-6.1|0.305
91691612|NCT00708552|183277504|SUPERIORITY||Mean Difference (Net)|2.0||||0.282|TWO_SIDED|95.0|-1.7|5.7|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs Donepezil at Week 24||5.7|-1.7|0.282
91691613|NCT00708552|183277505|SUPERIORITY||Mean Difference (Net)|1.4||||0.096|TWO_SIDED|95.0|-0.3|3.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.1|-0.3|0.096
91691614|NCT00708552|183277505|SUPERIORITY||Mean Difference (Net)|1.0||||0.281|TWO_SIDED|95.0|-0.8|2.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||2.8|-0.8|0.281
91691615|NCT00708552|183277505|SUPERIORITY||Mean Difference (Net)|0.4||||0.63|TWO_SIDED|95.0|-1.1|1.9|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.9|-1.1|0.630
91691616|NCT00708552|183277505|SUPERIORITY||Mean Difference (Net)|-1.1||||0.655|TWO_SIDED|95.0|-5.7|3.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-5.7|0.655
91691617|NCT00708552|183277505|SUPERIORITY||Mean Difference (Net)|-1.5||||0.545|TWO_SIDED|95.0|-6.2|3.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.3|-6.2|0.545
91691618|NCT00708552|183277505|SUPERIORITY||Mean Difference (Net)|2.4||||0.27|TWO_SIDED|95.0|-1.9|6.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 24||6.8|-1.9|0.270
91691619|NCT00708552|183277506|SUPERIORITY||Mean Difference (Net)|1.5||||0.138|TWO_SIDED|95.0|-0.5|3.6|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-0.5|0.138
91691620|NCT00708552|183277506|SUPERIORITY||Mean Difference (Net)|1.3||||0.216|TWO_SIDED|95.0|-0.7|3.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||3.2|-0.7|0.216
91691621|NCT00708552|183277506|SUPERIORITY||Mean Difference (Net)|-0.1||||0.921|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.921
91691622|NCT00708552|183277506|SUPERIORITY||Mean Difference (Net)|-2.1||||0.41|TWO_SIDED|95.0|-7.0|2.9|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||2.9|-7.0|0.410
91691623|NCT00708552|183277506|SUPERIORITY||Mean Difference (Net)|-1.1||||0.667|TWO_SIDED|95.0|-5.9|3.8|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.8|-5.9|0.667
91691624|NCT00708552|183277506|SUPERIORITY||Mean Difference (Net)|2.7||||0.246|TWO_SIDED|95.0|-1.9|7.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 24||7.2|-1.9|0.246
91691625|NCT00708552|183277507|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.1|0.146
91691626|NCT00708552|183277507|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.733|TWO_SIDED|95.0|-0.4|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-35mg at Week 24||0.3|-0.4|0.733
91691627|NCT00708552|183277507|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs Donepezil at Week 24||0.1|-0.5|0.145
91691628|NCT00708552|183277508|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.295|TWO_SIDED|95.0|-0.2|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.2|0.295
91691629|NCT00708552|183277508|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.495|TWO_SIDED|95.0|-0.5|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.5|0.495
91691630|NCT00708552|183277508|SUPERIORITY||Mean Difference (Net)|-0.3||||0.166|TWO_SIDED|95.0|-0.6|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs Donepezil at Week 24||0.1|-0.6|0.166
91691631|NCT00708552|183277509|SUPERIORITY||Mean Difference (Net)|0.1||||0.847|TWO_SIDED|95.0|-1.1|1.4|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 12||1.4|-1.1|0.847
91691632|NCT00708552|183277509|SUPERIORITY||Mean Difference (Net)|-0.1||||0.833|TWO_SIDED|95.0|-1.4|1.1|||Mixed Models Analysis|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 12||1.1|-1.4|0.833
91691633|NCT00708552|183277509|SUPERIORITY||Mean Difference (Net)|-0.5||||0.443|TWO_SIDED|95.0|-1.6|0.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepzil at Week 12||0.7|-1.6|0.443
91489334|NCT00074984|182851380|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.465||||0.0577|TWO_SIDED|95.0|0.211|1.025|||Wald Test|||Time to First Primary Endpoint Adjusting for Baseline Proteinuria using Cox Proportional Hazards Model||1.025|0.211|0.0577
91691634|NCT00708552|183277510|SUPERIORITY||Mean Difference (Net)|0.1||||0.32|TWO_SIDED|95.0|-0.1|0.3|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.1|0.320
91691635|NCT00708552|183277510|SUPERIORITY||Mean Difference (Net)|0.0||||0.927|TWO_SIDED|95.0|-0.2|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.2|0.927
91691636|NCT00708552|183277510|SUPERIORITY||Mean Difference (Net)|-0.2||||0.059|TWO_SIDED|95.0|-0.4|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepzil at Week 12||0.0|-0.4|0.059
91691637|NCT00708552|183277511|SUPERIORITY||Mean Difference (Net)|-1.9||||0.257|TWO_SIDED|95.0|-5.2|1.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-15mg at Week 12||1.4|-5.2|0.257
91691638|NCT00708552|183277511|SUPERIORITY||Mean Difference (Net)|0.9||||0.57|TWO_SIDED|95.0|-2.2|4.0|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-35mg at Week 12||4.0|-2.2|0.570
91691639|NCT00708552|183277511|SUPERIORITY||Mean Difference (Net)|3.4||||0.031|TWO_SIDED|95.0|0.3|6.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs Donepzil at Week 12||6.4|0.3|0.031
91691640|NCT00708552|183277512|SUPERIORITY||Mean Difference (Net)|0.2||||0.798|TWO_SIDED|95.0|-1.1|1.5|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.5|-1.1|0.798
91691641|NCT00708552|183277512|SUPERIORITY||Mean Difference (Net)|0.1||||0.918|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.918
91691642|NCT00708552|183277512|SUPERIORITY||Mean Difference (Net)|0.1||||0.924|TWO_SIDED|95.0|-1.2|1.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||1.3|-1.2|0.924
91691643|NCT00708552|183277512|SUPERIORITY||Mean Difference (Net)|-0.8||||0.676|TWO_SIDED|95.0|-4.7|3.0|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||3.0|-4.7|0.676
91691644|NCT00708552|183277512|SUPERIORITY||Mean Difference (Net)|3.1||||0.086|TWO_SIDED|95.0|-0.4|6.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||6.7|-0.4|0.086
91691645|NCT00708552|183277512|SUPERIORITY||Mean Difference (Net)|4.2||||0.021|TWO_SIDED|95.0|0.6|7.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 12||7.7|0.6|0.021
91691646|NCT00708552|183277513|SUPERIORITY||Mean Difference (Net)|0.1||||0.908|TWO_SIDED|95.0|-1.5|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.7|-1.5|0.908
91691647|NCT00708552|183277513|SUPERIORITY||Mean Difference (Net)|-0.2||||0.826|TWO_SIDED|95.0|-1.7|1.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.7|0.826
91691648|NCT00708552|183277513|SUPERIORITY||Mean Difference (Net)|-1.2||||0.088|TWO_SIDED|95.0|-2.7|0.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||0.2|-2.7|0.088
91691649|NCT00708552|183277513|SUPERIORITY||Mean Difference (Net)|-3.6||||0.053|TWO_SIDED|95.0|-7.3|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||0.0|-7.3|0.053
91691650|NCT00708552|183277513|SUPERIORITY||Mean Difference (Net)|-0.4||||0.848|TWO_SIDED|95.0|-4.0|3.3|||Mixed Models Analysis|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||3.3|-4.0|0.848
91691651|NCT00708552|183277513|SUPERIORITY||Mean Difference (Net)|4.7||||0.011|TWO_SIDED|95.0|1.1|8.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 12||8.2|1.1|0.011
91691652|NCT00708552|183277514|SUPERIORITY||Mean Difference (Net)|0.1||||0.671|TWO_SIDED|95.0|-0.2|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.2|0.671
91691653|NCT00708552|183277514|SUPERIORITY||Mean Difference (Net)|-0.1||||0.413|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.4|0.413
91691654|NCT00708552|183277514|SUPERIORITY||Mean Difference (Net)|-0.1||||0.245|TWO_SIDED|95.0|-0.4|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.1|-0.4|0.245
91691655|NCT00708552|183277515|SUPERIORITY||Mean Difference (Net)|0.1||||0.369|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.4|-0.2|0.369
91691656|NCT00708552|183277515|SUPERIORITY||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.4|-0.2|0.550
91691657|NCT00708552|183277515|SUPERIORITY||Mean Difference (Net)|-0.3||||0.082|TWO_SIDED|95.0|-0.5|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.0|-0.5|0.082
91691658|NCT00708552|183277516|SUPERIORITY||Mean Difference (Net)|-0.7||||0.417|TWO_SIDED|95.0|-2.4|1.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 12||1.0|-2.4|0.417
91691659|NCT00708552|183277516|SUPERIORITY||Mean Difference (Net)|0.3||||0.725|TWO_SIDED|95.0|-1.4|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 12||2.0|-1.4|0.725
91691660|NCT00708552|183277516|SUPERIORITY||Mean Difference (Net)|0.6||||0.506|TWO_SIDED|95.0|-1.1|2.2|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 12||2.2|-1.1|0.506
91691661|NCT00708552|183277516|SUPERIORITY||Mean Difference (Net)|-0.3||||0.723|TWO_SIDED|95.0|-2.3|1.6|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 24||1.6|-2.3|0.723
91691662|NCT00708552|183277516|SUPERIORITY||Median Difference (Net)|-0.1||||0.919|TWO_SIDED|95.0|-2.2|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 24||2.0|-2.2|0.919
91691663|NCT00708552|183277516|SUPERIORITY||Mean Difference (Net)|-0.1||||0.896|TWO_SIDED|95.0|-2.3|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 24||2.0|-2.3|0.896
91691664|NCT00708552|183277517|SUPERIORITY||Mean Difference (Net)|-0.2||||0.594|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.9|0.594
91691665|NCT00708552|183277517|SUPERIORITY||Mean Difference (Net)|0.2||||0.523|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-35mg at Week 24||0.9|-0.5|0.523
91691666|NCT00708552|183277517|SUPERIORITY||Mean Difference (Net)|0.3||||0.429|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||CSDD Total score, Placebo Vs Donepezil at Week 24||1.0|-0.4|0.429
91691667|NCT00708552|183277518|SUPERIORITY||Mean Difference (Net)|0.0||||0.966|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-15mg at Week 24||0.8|-0.8|0.966
91691668|NCT00708552|183277518|SUPERIORITY||Mean Difference (Net)|0.3||||0.505|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-35mg at Week 24||1.1|-0.5|0.505
91691669|NCT00708552|183277518|SUPERIORITY||Mean Difference (Net)|0.8||||0.044|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||MMSE Total score, Placebo Vs Donepezil at Week 24||1.6|0.0|0.044
91691670|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 12||0.5|-0.5|0.869
91691671|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 12||0.8|-0.4|0.500
91691672|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 12||0.8|-0.1|0.140
91691673|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.0||||0.91|TWO_SIDED|95.0|-0.6|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.6|0.910
91691674|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.1||||0.774|TWO_SIDED|95.0|-0.5|0.7|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 24||0.7|-0.5|0.774
91691675|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 24||0.5|-0.7|0.726
91691676|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|-0.8||||0.292|TWO_SIDED|95.0|-2.2|0.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 12||0.7|-2.2|0.292
91691677|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.0||||0.946|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.946
91691678|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.2||||0.802|TWO_SIDED|95.0|-1.3|1.6|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 12||1.6|-1.3|0.802
91489335|NCT00074984|182851381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5261|TWO_SIDED|95.0|0.278|1.927|||Log Rank|2-sided log-rank test||Analysis of Time to First Renal Event for ITT population.||1.927|0.278|0.5261
91691679|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|-0.4||||0.636|TWO_SIDED|95.0|-2.1|1.3|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 24||1.3|-2.1|0.636
91489336|NCT03758443|182851385|SUPERIORITY||Least Square Mean Difference|-0.27||||0.5809|TWO_SIDED|95.0|-1.22|0.69|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.69|-1.22|0.5809
91691680|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|-0.3||||0.752|TWO_SIDED|95.0|-2.0|1.5|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 24||1.5|-2.0|0.752
91691681|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|-0.1||||0.92|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.920
91691682|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.0||||0.972|TWO_SIDED|95.0|-0.7|0.6|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 12||0.6|-0.7|0.972
91691683|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.3||||0.378|TWO_SIDED|95.0|-0.4|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 12||0.9|-0.4|0.378
91691684|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.3||||0.346|TWO_SIDED|95.0|-0.3|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 12||0.9|-0.3|0.346
91691685|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.6|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 24||0.9|-0.6|0.720
91691686|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.2||||0.598|TWO_SIDED|95.0|-0.6|1.0|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 24||1.0|-0.6|0.598
91691687|NCT00708552|183277519|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 24||1.1|-0.5|0.480
91691688|NCT03971071|183277567|SUPERIORITY||Common odds ratio|1.37||||0.13|TWO_SIDED|95.0|0.92|2.05|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.05|0.92|0.13
91691689|NCT03971071|183277567|SUPERIORITY||Common odds ratio|2.01|||<|0.001|TWO_SIDED|95.0|1.33|3.05|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.05|1.33|<0.001
91691690|NCT03971071|183277568|SUPERIORITY||Least squares mean difference|-1.23||||0.033|TWO_SIDED|95.0|-2.35|-0.1||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.10|-2.35|0.033
91691691|NCT03971071|183277568|SUPERIORITY||Least squares mean difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.87|-1.62||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-1.62|-3.87|<0.001
91691692|NCT03971071|183277569|SUPERIORITY||Common odds ratio|1.62||||0.019|TWO_SIDED|95.0|1.08|2.43|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.43|1.08|0.019
91691693|NCT03971071|183277569|SUPERIORITY||Common odds ratio|2.63|||<|0.001|TWO_SIDED|95.0|1.75|3.96|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.96|1.75|<0.001
91691694|NCT03971071|183277570|SUPERIORITY||Least squares mean difference|-3.25||||0.007|TWO_SIDED|95.0|-5.62|-0.88||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.88|-5.62|0.007
91691695|NCT03971071|183277570|SUPERIORITY||Least squares mean difference|-2.13||||0.075|TWO_SIDED|95.0|-4.48|0.22||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||0.22|-4.48|0.075
91489337|NCT03758443|182851385|SUPERIORITY||Least Square Mean Difference|-0.37||||0.4501|TWO_SIDED|95.0|-1.33|0.59|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.59|-1.33|0.4501
91691696|NCT03971071|183277571|SUPERIORITY||Least squares mean difference|-2.61||||0.028|TWO_SIDED|95.0|-4.92|-0.29||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.29|-4.92|0.028
91691697|NCT03971071|183277571|SUPERIORITY||Least squares mean difference|-2.37||||0.043|TWO_SIDED|95.0|-4.67|-0.07||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.07|-4.67|0.043
91691698|NCT00360282|183277594|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Sign test|||||||0.007
91691699|NCT00360282|183277595|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Sign test|||||||.549
91691700|NCT04537078|183277596|OTHER||Median Difference (Final Values)|1.5||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
91489338|NCT03758443|182851385|SUPERIORITY||Least Square Mean Difference|-0.65||||0.1809|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.30|-1.60|0.1809
91489339|NCT03758443|182851386|SUPERIORITY|||||||0.3762|||||||Fisher Exact|||||||0.3762
91489340|NCT03758443|182851386|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489341|NCT03758443|182851386|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489342|NCT03758443|182851387|SUPERIORITY||Difference in Proportion|0.0||||0.9542|TWO_SIDED|95.0|-0.104|0.11||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.110|-0.104|0.9542
91527344|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.1506|||TWO_SIDED|95.0|-0.104|0.49|||||Comparison of FEV1, Day 7, 12 hour|||0.490|-0.104|
91489343|NCT03758443|182851387|SUPERIORITY||Difference in Proportion|-0.03||||0.5863|TWO_SIDED|95.0|-0.126|0.071||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.071|-0.126|0.5863
91527345|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.1601|||TWO_SIDED|95.0|-0.136|0.495|||||Comparison of FEV1, Day 7, 24 hour|||0.495|-0.136|
91527346|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.2029|||TWO_SIDED|95.0|-0.263|0.537|||||Comparison of FVC, Day 1, 1 hour|||0.537|-0.263|
91527347|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.1965|||TWO_SIDED|95.0|-0.257|0.518|||||Comparison of FVC, Day 1, 2 hour|||0.518|-0.257|
91691701|NCT04537078|183277597|OTHER||Median Difference (Final Values)|9.48||||0.219|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.219
91691702|NCT04537078|183277598|OTHER||Median Difference (Final Values)|1.0||||0.269|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.269
91691703|NCT04537078|183277599|OTHER||Median Difference (Final Values)|0.0||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.072
91691704|NCT04537078|183277600|OTHER|||||||1|||||||Fisher Exact|||||||1
91691705|NCT04537078|183277601|OTHER|||||||0.72|||||||Chi-squared|||||||0.720
91489344|NCT03758443|182851387|SUPERIORITY||Difference in Proportion|-0.03||||0.5408|TWO_SIDED|95.0|-0.131|0.069||P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.069|-0.131|0.5408
91489345|NCT03758443|182851388|SUPERIORITY|||||||0.6656|||||||Fisher Exact|||||||0.6656
91489346|NCT03758443|182851388|SUPERIORITY|||||||0.6424|||||||Fisher Exact|||||||0.6424
91489347|NCT03758443|182851388|SUPERIORITY|||||||0.6199|||||||Fisher Exact|||||||0.6199
91489348|NCT03758443|182851389|SUPERIORITY|||||||0.2643|||||||Fisher Exact|||||||0.2643
91489349|NCT03758443|182851389|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489350|NCT03758443|182851389|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489351|NCT03758443|182851390|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489352|NCT03758443|182851390|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489353|NCT03758443|182851390|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91489354|NCT03080454|182851391|EQUIVALENCE|Statistical analysis for mean percent change from baseline in area under the curve for the resistance torque measure across 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean percent change in area under the curve between anodal and sham Doublestim conditions. A significance level of 0.05 was used (two-sided).||||||0.004||||||A 2x2 repeated measures ANOVA was performed with condition (mean percent change in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.004
91527348|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.038|STANDARD_ERROR_OF_MEAN|0.1908|||TWO_SIDED|95.0|-0.414|0.338|||||Comparison of FVC, Day 1, 4 hour|||0.338|-0.414|
91527349|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2013|||TWO_SIDED|95.0|-0.337|0.457|||||Comparison of FVC, Day 1, 9 hour|||0.457|-0.337|
91527350|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.2322|||TWO_SIDED|95.0|-0.343|0.572|||||Comparison of FVC, Day 1, 12 hour|||0.572|-0.343|
91527351|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.1988|||TWO_SIDED|95.0|-0.277|0.507|||||Comparison of FVC, Day 1, 24 hour|||0.507|-0.277|
91527352|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.362|STANDARD_ERROR_OF_MEAN|0.2801|||TWO_SIDED|95.0|-0.19|0.914|||||Comparison of FVC, Day 7, Baseline|||0.914|-0.190|
91527353|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|STANDARD_ERROR_OF_MEAN|0.2696|||TWO_SIDED|95.0|-0.263|0.8|||||Comparison of FVC, Day 7, 1 hour|||0.800|-0.263|
91527354|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.2648|||TWO_SIDED|95.0|-0.501|0.543|||||Comparison of FVC, Day 7, 2 hour|||0.543|-0.501|
91691706|NCT04537078|183277602|OTHER||Median Difference (Final Values)|2.0||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
91691707|NCT04537078|183277603|OTHER||Median Difference (Final Values)|600.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
91691708|NCT04537078|183277604|OTHER||Median Difference (Final Values)|2.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
91691709|NCT04537078|183277605|OTHER||Median Difference (Final Values)|33.33||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91691710|NCT04537078|183277606|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91691711|NCT04537078|183277607|OTHER||Median Difference (Final Values)|0.0||||0.851|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.851
91489355|NCT03080454|182851392|EQUIVALENCE|Statistical analysis for mean Tardieu Scale Score summed across 11 joints of the upper extremity in 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean change between anodal and sham Doubleestim conditions. A significance level of 0.05 was used (two-sided).||||||0.003||||||A 2x2 repeated measures ANOVA was performed with condition (mean score in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.003
91489356|NCT03863197|182851395|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91527355|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177|STANDARD_ERROR_OF_MEAN|0.2606|||TWO_SIDED|95.0|-0.337|0.691|||||Comparison of FVC, Day 7, 4 hour|||0.691|-0.337|
91691712|NCT04537078|183277608|OTHER||Median Difference (Final Values)|25.0||||0.304|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.304
91691713|NCT04537078|183277609|OTHER||Median Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.486
91691714|NCT03207815|183277610|SUPERIORITY||Difference in Treatment Failure Rate|-30.1||||0.0064|TWO_SIDED|95.0|-56.2|-4.1||P-value was estimated from the Cochran-Mantel-Haenszel (CMH) test, adjusted for the stratification factors.|Cochran-Mantel-Haenszel|Participants with missing values on treatment failure status were analyzed as treatment failures using a nonresponder imputation (NRI) method.||||-4.1|-56.2|0.0064
91691715|NCT03207815|183277611|SUPERIORITY||Stratified Hazard Ratio|0.309||||0.0014|TWO_SIDED|95.0|0.144|0.663||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% confidence interval \[CI\]) were derived from the Cox model stratified by the stratification factors.|||0.663|0.144|0.0014
91691716|NCT03207815|183277612|SUPERIORITY||Least Squares Mean Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.355|TWO_SIDED|95.0|-0.4|0.2||P-value was estimated using a repeated measure Analysis of Covariance (ANCOVA) model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in Least Squares (LS)-means (95% CI) were obtained from the repeated measure ANCOVA model.|||0.2|-0.4|0.3550
91691717|NCT03207815|183277613|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0145|TWO_SIDED|95.0|-0.8|-0.1||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.1|-0.8|0.0145
91691718|NCT03207815|183277614|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0389|TWO_SIDED|95.0|-0.1|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.10|0.0389
91691719|NCT03207815|183277615|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.034|TWO_SIDED|95.0|-0.05|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, OCT machine, and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.05|0.0340
91691720|NCT03207815|183277616|SUPERIORITY||Stratified Hazard Ratio|1.193||||0.5893|TWO_SIDED|95.0|0.625|2.277||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% CI) were derived from the Cox model stratified by the stratification factors.|||2.277|0.625|0.5893
91691721|NCT00391768|183277625|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Spearman Correlation|||||||0.07
91691722|NCT00391768|183277625|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Spearman Correlation|||||||0.60
91691723|NCT00391768|183277625|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Spearman Correlation|||||||0.27
91691724|NCT00391768|183277625|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Spearman Correlation|||||||0.77
91691725|NCT00391768|183277625|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Spearman Correlation|||||||0.47
91691726|NCT00391768|183277625|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Spearman Correlation|||||||0.96
91691727|NCT01620138|183277627|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91691728|NCT00444535|183277641|OTHER|Clopper-Pearson exact test (binomial)|Exact binomial procedure|69.2||||||95.0|54.9|81.3||||||||81.3|54.9|
91691729|NCT01568892|183277648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|||<|0.001|TWO_SIDED|95.0|-1.52|-0.8|||ANCOVA||The estimated value represents the adjusted mean difference between the two treatment arms.|||-0.80|-1.52|<0.001
91692150|NCT01262872|183279148|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|0.6|||||TWO_SIDED|95.0|-24.9|20.9||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||20.9|-24.9|
91489357|NCT03863197|182851396|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91527356|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.2684|||TWO_SIDED|95.0|-0.263|0.795|||||Comparison of FVC, Day 7, 9 hour|||0.795|-0.263|
91527357|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.2923|||TWO_SIDED|95.0|-0.209|0.943|||||Comparison of FVC, Day 7, 12 hour|||0.943|-0.209|
91691730|NCT01697748|183277701|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.44|1.96||Variables with at least a borderline association with a treatment arm (P≤ .10) were included in a multiple logistic regression model to verify which is independently associated with the outcome of interest||No P values were reported for the association between dressing type and infection, only relative risk and 95% confidence intervals were reported.||With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate|1.96|0.44|
91691731|NCT01697748|183277701|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|||||<|0.05|TWO_SIDED|95.0||||Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest|Mixed Models Analysis|In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.||||||<0.05
91691732|NCT01697748|183277702|SUPERIORITY||||||<|0.05|||||||see below|Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate|||In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate|||<.05
91691733|NCT01697748|183277703|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate|||<.05
91691734|NCT01697748|183277703|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate|||<.05
91691735|NCT01697748|183277705|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate|||<0.05
91691736|NCT01697748|183277706|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate|||<0.05
91691737|NCT01704495|183277707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.56||||0.119|TWO_SIDED|90.0|0.98|2.49||2-sided p-value|Poisson regression|Correction for overdispersion made by Pearson chi-square|AZD5069 45 mg BID vs Placebo|||2.49|0.98|0.119
91691738|NCT01704495|183277707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.53||||0.141|TWO_SIDED|90.0|0.95|2.46||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 15 mg BID vs Placebo|||2.46|0.95|0.141
91691739|NCT01704495|183277707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.397|TWO_SIDED|90.0|0.79|2.11||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 5 mg BID vs Placebo|||2.11|0.79|0.397
91691740|NCT01256450|183277749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.587|TWO_SIDED|95.0|-0.646|0.366|||ANCOVA|||||0.366|-0.646|.5870
91691741|NCT02104219|183277759|SUPERIORITY_OR_OTHER|||||||0.0755|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median RGI-C score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Pairs of radiographs were centrally evaluated by 3 independent, blinded pediatric radiologists trained in the assessment of the skeletal manifestations of HPP. The mean RGI-C score across the 3 radiologists was calculated and served as the patient's RGI-C score for a specific time point||||0.0755
91691742|NCT02104219|183277760|SUPERIORITY_OR_OTHER|||||||0.6344|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in height Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented height measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline height. Height measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in height Z-score from Baseline were computed by subtracting baseline height Z-score from post baseline height Z-scores. The post baseline time points were grouped by time intervals.||||0.6344
91722340|NCT04609553|183337081|SUPERIORITY|||||||0.14||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.14
91527358|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.242|STANDARD_ERROR_OF_MEAN|0.2665|||TWO_SIDED|95.0|-0.283|0.768|||||Comparison of FVC, Day 7, 24 hour|||0.768|-0.283|
91527359|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.2106|||TWO_SIDED|95.0|-0.263|0.567|||||Comparison of FVC, Day 1, 1 hour|||0.567|-0.263|
91527360|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.321|STANDARD_ERROR_OF_MEAN|0.2039|||TWO_SIDED|95.0|-0.081|0.723|||||Comparison of FVC, Day 1, 2 hour|||0.723|-0.081|
91691743|NCT02104219|183277761|SUPERIORITY_OR_OTHER|||||||0.452|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in weight Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented weight measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline weight. Weight measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in weight Z-score from Baseline were computed by subtracting baseline weight Z-score from post baseline weight Z-scores. The post baseline time points were grouped by time intervals.||||0.4520
91691744|NCT02104219|183277762|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether change from baseline in the median RSS score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The Baseline x-ray set defined for RGI-C, which was compared with its subsequent x-ray sets, was also used as the Baseline x-ray set for the RSS reading. Changes from Baseline were computed based on this baseline RSS score, and postbaseline time points were grouped by intervals of time from Baseline.||||0.4545
91691745|NCT02375971|183277763|SUPERIORITY|The primary efficacy variable was treatment success, defined as the absence of active ROP and absence of unfavorable structural outcomes in both eyes 24 weeks after starting study treatment.|Odds Ratio (OR)|2.19||||0.0254|TWO_SIDED|95.0|0.9932|4.8235|||Cochran-Mantel-Haenszel|||||4.8235|0.9932|0.0254
91691746|NCT02275819|183277785|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||.14
91691747|NCT02275819|183277786|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||.22
91691748|NCT02275819|183277787|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
91691749|NCT02275819|183277788|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||.08
91691750|NCT02275819|183277789|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
91691751|NCT02025725|183277804|SUPERIORITY|||||||0.881|||||||ANCOVA|||||||0.881
91691752|NCT02025725|183277805|SUPERIORITY||Mean Difference (Net)|-0.201||||0.036|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 1: metoclopramide nasal spray minus placebo.||||0.036
91691753|NCT02025725|183277805|SUPERIORITY||Mean Difference (Net)|-0.336||||0.025|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 2: metoclopramide nasal spray minus placebo||||0.025
91691754|NCT02025725|183277805|SUPERIORITY||Mean Difference (Net)|-0.347||||0.039|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 3: metoclopramide nasal spray minus placebo.||||0.039
91489358|NCT03863197|182851397|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91691755|NCT02025725|183277805|SUPERIORITY||Mean Difference (Net)|-0.364||||0.085|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 4: metoclopramide nasal spray minus placebo.||||0.085
91691756|NCT01787292|183277829|SUPERIORITY|||||||0.001||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation||||||.001
91691757|NCT01787292|183277830|SUPERIORITY|||||||0.8|||||||ANCOVA|||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.||||.8
91691758|NCT01787292|183277831|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|||||||.05
91691759|NCT01787292|183277832|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.||||||.05
91691760|NCT01787292|183277833|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
91691761|NCT01787292|183277834|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
91691762|NCT01787292|183277835|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
91691763|NCT01787292|183277836|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
91691764|NCT01787292|183277837|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|A Kenward-Rogers adjustment for df was made to account for carryover effects.||||||.6
91691765|NCT01787292|183277838|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
91691766|NCT01787292|183277839|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
91691767|NCT01787292|183277840|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
91691768|NCT01787292|183277841|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
91691769|NCT01597778|183277855|SUPERIORITY||Difference in Kaplan-Meier estimates|6.1||||0.4092|TWO_SIDED|95.0|-5.2|17.4||Statistical significance was determined using a pre-specified threshold of 0.05. Final p-value is adjusted for the interim looks per study design.|Z-test to compare the Kaplan-Meier Est.|||The primary null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM.||17.4|-5.2|0.4092
91691770|NCT01597778|183277855|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.06|TWO_SIDED|95.0|0.99|1.7||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||The null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM after adjustment for age, performance score, and disease type.||1.70|0.99|0.060
91691771|NCT01597778|183277857|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before neutrophil recovery is competing risk.||The null hypothesis is that there is no difference between the neutrophil engraftment post-transplantation for dUCB vs. haplo-BM.||||0.046
91489359|NCT03863197|182851398|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91527361|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.311|STANDARD_ERROR_OF_MEAN|0.1981|||TWO_SIDED|95.0|-0.079|0.701|||||Comparison of FVC, Day 1, 4 hour|||0.701|-0.079|
91691772|NCT01597778|183277858|SUPERIORITY|||||||0.16||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 20k post-transplantation for dUCB vs. haplo-BM.||||0.160
91691773|NCT01597778|183277858|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 50k post-transplantation for dUCB vs. haplo-BM.||||0.146
91691774|NCT01597778|183277860|SUPERIORITY|||||||0.693||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before 2nd graft failure is competing risk.||The null hypothesis is that there is no difference between the secondary graft failure probabilities post-transplantation for dUCB vs. haplo-BM.||||0.693
91691775|NCT01597778|183277861|SUPERIORITY|||||||0.142||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade II - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.142
91691776|NCT01597778|183277861|SUPERIORITY|||||||0.604||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade III - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.604
91691777|NCT01597778|183277862|SUPERIORITY|||||||0.361||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before cGVHD is competing risk.||The null hypothesis is that there is no difference between the cGVHD probabilities post-transplantation for dUCB vs. haplo-BM.||||0.361
91691778|NCT01597778|183277863|SUPERIORITY|||||||0.0373||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-randomization for dUCB vs. haplo-BM.||||0.0373
91691779|NCT01597778|183277863|SUPERIORITY|||||||0.0235||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-transplant for dUCB vs. haplo-BM.||||0.0235
91691780|NCT01597778|183277864|SUPERIORITY|||||||0.039||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-randomization for dUCB vs. haplo-BM.||||0.039
91691781|NCT01597778|183277864|SUPERIORITY|||||||0.03||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-transplantation for dUCB vs. haplo-BM||||0.030
91691782|NCT01597778|183277865|SUPERIORITY|||||||0.968||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post-randomization for dUCB vs. haplo-BM.||||0.968
91691783|NCT01597778|183277865|SUPERIORITY|||||||0.907||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post- transplantation for dUCB vs. haplo-BM.||||0.907
91691784|NCT01597778|183277868|SUPERIORITY|||||||0.0003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference between the total duration of hospitalization within 6 months post-randomization for dUCB vs. haplo-BM.||||0.0003
91489360|NCT03863197|182851399|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91489361|NCT03863197|182851400|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91527362|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|-0.064|0.76|||||Comparison of FVC, Day 1, 9 hour|||0.760|-0.064|
91489362|NCT03863197|182851404|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91691785|NCT05691712|183277873|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-19.9|-12.36|||Mixed Models Analysis|||||-12.36|-19.9|<0.001
91691786|NCT05691712|183277873|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-19.7|-12.1|||Mixed Models Analysis|||||-12.10|-19.7|<0.001
91691787|NCT05691712|183277874|SUPERIORITY||LS Mean Difference|-13.06|||<|0.001|TWO_SIDED|95.0|-16.8|-9.34|||Mixed Models Analysis|||||-9.34|-16.8|<0.001
91691788|NCT05691712|183277875|SUPERIORITY||LS Mean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-5.8|-2.9|||Mixed Models Analysis|||||-2.9|-5.8|<0.001
91691789|NCT05691712|183277875|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-8.0|-5.0|||Mixed Models Analysis|||||-5.0|-8.0|<0.001
91691790|NCT05691712|183277875|SUPERIORITY||LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|95.0|-7.5|-4.5|||Mixed Models Analysis|||||-4.5|-7.5|<0.001
91691791|NCT05691712|183277877|SUPERIORITY||LS Mean Difference|-21.9|||<|0.001|TWO_SIDED|95.0|-32.4|-11.3|||Mixed Models Analysis|||||-11.3|-32.4|<0.001
91691792|NCT05691712|183277877|SUPERIORITY||LS Mean Difference|-28.9|||<|0.001|TWO_SIDED|95.0|-39.6|-18.1|||Mixed Models Analysis|||||-18.1|-39.6|<0.001
91691793|NCT05691712|183277877|SUPERIORITY||LS Mean Difference|-27.3|||<|0.001|TWO_SIDED|95.0|-38.2|-16.5|||Mixed Models Analysis|||||-16.5|-38.2|<0.001
91691794|NCT00226499|183277909|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.943|||<|0.0001|TWO_SIDED|97.5|92.446|96.615|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||96.615|92.446|<0.0001
91691795|NCT00226499|183277909|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|65.428||||0.1265|TWO_SIDED|97.5|57.182|72.086|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||72.086|57.182|0.1265
91691796|NCT00226499|183277910|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.498||||0.0001|TWO_SIDED|95.0|97.522|99.898|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.898|97.522|0.0001
91691797|NCT00226499|183277910|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|90.741||||0.1265|TWO_SIDED|95.0|85.866|93.934|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||93.934|85.866|0.1265
91691798|NCT00226499|183277911|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|92.487|||<|0.0001|TWO_SIDED|95.0|89.927|94.396|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||94.396|89.927|<0.0001
91691799|NCT00226499|183277911|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|64.585||||0.1265|TWO_SIDED|95.0|57.503|70.486|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||70.486|57.503|0.1265
91691800|NCT00226499|183277931|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|95.855|||<|0.0001|TWO_SIDED|95.0|94.075|97.101|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||97.101|94.075|<0.0001
91691801|NCT00226499|183277931|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|69.812||||0.1265|TWO_SIDED|95.0|62.848|75.47|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||75.470|62.848|0.1265
91691802|NCT00226499|183277932|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.072|||<|0.0001|TWO_SIDED|95.0|97.907|99.589|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.589|97.907|<0.0001
91722341|NCT04609553|183337081|SUPERIORITY|||||||0.007||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.007
91722342|NCT04609553|183337081|SUPERIORITY|||||||0.34||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.34
91489363|NCT03863197|182851405|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
91691803|NCT00226499|183277932|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|89.532||||0.1265|TWO_SIDED|95.0|86.126|92.102|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||92.102|86.126|0.1265
91489364|NCT01781975|182851406|SUPERIORITY||ANCOVA|0.0616|STANDARD_ERROR_OF_MEAN|0.0364||0.048|TWO_SIDED|90.0|0.00176|0.121|||ANCOVA|||||0.121|0.00176|0.048
91489365|NCT04545060|182851443|SUPERIORITY||adjusted relative risk ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.09|0.5||two-sided, alpha=0.05|poisson regression model|||||0.50|0.09|<0.001
91691804|NCT00226499|183277933|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.816|||<|0.0001|TWO_SIDED|95.0|92.838|96.248|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||96.248|92.838|<0.0001
91489366|NCT04545060|182851461|SUPERIORITY||relative risk ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.19|0.63||two-sided, alpha=0.05|poisson regression model|||||0.63|0.19|<0.001
91489367|NCT04545060|182851462|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.38|-0.76||two-sided, alpha=0.05|ANCOVA|||||-0.76|-1.38|<0.001
91527363|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.245|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-0.23|0.72|||||Comparison of FVC, Day 1, 12 hour|||0.720|-0.230|
91691805|NCT00226499|183277933|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|68.932||||0.1265|TWO_SIDED|95.0|61.893|74.671|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||74.671|61.893|0.1265
91691806|NCT02723344|183277946|OTHER|||||||0.056|||||||Wilcoxon-rank sum|||||||.056
91691807|NCT02723344|183277947|OTHER|||||||0.26||||||Wilcoxon Rank-Sum|Wilcoxon (Mann-Whitney)|||||||.26
91691808|NCT02723344|183277949|OTHER|||||||0.64|||||||Wilcoxon Rank-Sum|||||||.64
91691809|NCT03473184|183277954|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||1|||||||ANOVA|||Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.||||1.0000
91691810|NCT03473184|183277954|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||0.0008|||||||ANOVA|||Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.||||0.0008
91691811|NCT02524847|183277955|OTHER||Overall response rate (%)|55.2|||<|0.001|TWO_SIDED|95.0|35.7|73.6|||t-test, 2 sided|2-sided p-value for testing the null hypothesis H0: Standard therapy has a CR+PR rate = 10% after 4 weeks, using the exact Binomial test.||||73.6|35.7|<.001
91691812|NCT01268527|183277969|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|711.4||||0.0038|TWO_SIDED|95.0|292.5|1130.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, Least Squares Means (LSM), and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1130.3|292.5|0.0038
91489368|NCT04545060|182851464|SUPERIORITY||Least squares mean difference|-0.232||||0.007|TWO_SIDED|95.0|-0.399|-0.065||two-sided, alpha=0.05|Mixed model repeated measures|||||-0.065|-0.399|0.007
91691813|NCT01268527|183277969|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1119.8|||<|0.0001|TWO_SIDED|95.0|858.9|1380.6|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1380.6|858.9|<0.0001
91691814|NCT01268527|183277969|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|780.0||||0.0523|TWO_SIDED|95.0|-8.5|1568.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1568.5|-8.5|0.0523
91489369|NCT04545060|182851468|SUPERIORITY||relative risk ratio|0.26||||0.002|TWO_SIDED|95.0|0.12|0.59||two-sided, alpha=0.05|poisson regression model|||||0.59|0.12|0.002
91489370|NCT00657358|182851501|SUPERIORITY_OR_OTHER||R^2 (adj)|0.477|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|DF=2 DFDEN=371.8, F-ratio=10.66||||||<0.001
91489371|NCT00347360|182851525|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
91489372|NCT00347360|182851526|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
91489373|NCT02012283|182851541|OTHER|paired t-test|Mean Difference (Final Values)|78.4||||0.001|TWO_SIDED|95.0||||p\<0.05 is defined as significant|t-test, 2 sided|||Difference between plain and spiced broccoli intake was compared.||||0.001
91527364|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.2063|||TWO_SIDED|95.0|-0.245|0.569|||||Comparison of FVC, Day 1, 24 hour|||0.569|-0.245|
91722343|NCT04609553|183337082|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.99
91722344|NCT04609553|183337082|SUPERIORITY|||||||0.07||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 9-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.07
91722345|NCT04609553|183337082|SUPERIORITY|||||||0.41||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 2.||||0.41
91722346|NCT04609553|183337082|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Analysis at the 18-month follow-up. A total of 630 parent-infant dyads (210 per arm) were needed to achieve 80% power to detect a 0.3 standard deviation (SD) difference assuming approximately 20% attrition. The null hypothesis was that there would be no differences between Arm 1 and Arm 3.||||0.03
91722347|NCT01035788|183337085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|7.24||0.849|TWO_SIDED|95.0|-1.39|13.2|||Mixed Models Analysis|p value was obtained from the contrast of the linear mixed model||We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.||13.2|-1.39|.849
91722348|NCT03829475|183337087|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91722349|NCT01433913|183337097|OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
91722350|NCT01433913|183337098|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91489374|NCT02012283|182851542|OTHER|paired t-test|Mean Difference (Final Values)|101.3||||0.031|TWO_SIDED|||||p\<0.05 is defined as significant.|t-test, 2 sided|||Comparison was made to the broccoli intake with and without spices among low restraint eaters vs. the change among high restraint eaters.||||0.031
91489375|NCT00621959|182851563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.546||95.0|-0.59|0.31||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA including treatment and center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.31|-0.59|0.546
91489376|NCT00621959|182851564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08||||0.442||95.0|-0.27|0.12||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.12|-0.27|0.442
91527365|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.535|STANDARD_ERROR_OF_MEAN|0.2907|||TWO_SIDED|95.0|-0.038|1.108|||||Comparison of FVC, Day 7, Baseline|||1.108|-0.038|
91722351|NCT01433913|183337099|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91722352|NCT01433913|183337100|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
91722353|NCT01433913|183337101|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
91722354|NCT01433913|183337105|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91722355|NCT01433913|183337106|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91722356|NCT01433913|183337107|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91722357|NCT01433913|183337108|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91722358|NCT01433913|183337109|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91722359|NCT00689936|183337119|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||6e-05|TWO_SIDED|95.0|0.61|0.85||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.85|0.61|0.00006
91722360|NCT00689936|183337119|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||1e-05|TWO_SIDED|95.0|0.6|0.82||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.82|0.60|0.00001
91527366|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.623|STANDARD_ERROR_OF_MEAN|0.2798|||TWO_SIDED|95.0|0.072|1.175|||||Comparison of FVC, Day 7, 1 hour|||1.175|0.072|
91527367|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.459|STANDARD_ERROR_OF_MEAN|0.2748|||TWO_SIDED|95.0|-0.083|1.0|||||Comparison of FVC, Day 7, 2 hour|||1.000|-0.083|
91722361|NCT00689936|183337119|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.70349|TWO_SIDED|95.0|0.89|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.20|0.89|0.70349
91722362|NCT00689936|183337120|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|1e-05|TWO_SIDED|95.0|0.59|0.79||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.79|0.59|<0.00001
91722363|NCT00689936|183337120|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|1e-05|TWO_SIDED|95.0|0.6|0.81||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.81|0.60|<0.00001
91722364|NCT00689936|183337120|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.91161|TWO_SIDED|95.0|0.86|1.14||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.14|0.86|0.91161
91489377|NCT02484690|182851567|SUPERIORITY||Difference in Least Squares Means|1.57||||0.5244|TWO_SIDED|80.0|-1.6|4.74||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||4.74|-1.60|0.5244
91489378|NCT02484690|182851567|SUPERIORITY||Difference in Least Squares Means|-1.59||||0.5308|TWO_SIDED|80.0|-4.86|1.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.67|-4.86|0.5308
91489379|NCT02484690|182851567|SUPERIORITY||Difference in Least Squares Means|-1.51||||0.5309|TWO_SIDED|80.0|-4.62|1.59||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.59|-4.62|0.5309
91527368|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.464|STANDARD_ERROR_OF_MEAN|0.2705|||TWO_SIDED|95.0|-0.069|0.997|||||Comparison of FVC, Day 7, 4 hour|||0.997|-0.069|
91691815|NCT01268527|183277969|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1775.1|||<|0.0001|TWO_SIDED|95.0|1392.3|2158.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||2158.0|1392.3|<0.0001
91691816|NCT01268527|183277969|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|921.4||||0.0002|TWO_SIDED|95.0|515.7|1327.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1327.1|515.7|0.0002
91691817|NCT01268527|183277969|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|937.8||||0.0115|TWO_SIDED|95.0|267.6|1607.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1607.9|267.6|0.0115
91722365|NCT00689936|183337121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.00234|TWO_SIDED|95.0|0.67|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.67|0.00234
91527369|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.445|STANDARD_ERROR_OF_MEAN|0.2786|||TWO_SIDED|95.0|-0.104|0.994|||||Comparison of FVC, Day 7, 9 hour|||0.994|-0.104|
91691818|NCT01268527|183277970|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|101.5||||0.0042|TWO_SIDED|95.0|36.0|167.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||167.0|36.0|0.0042
91691819|NCT01268527|183277970|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|182.4|||<|0.0001|TWO_SIDED|95.0|140.3|224.4|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||224.4|140.3|<0.0001
91691820|NCT01268527|183277970|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|169.5|||<|0.0001|TWO_SIDED|95.0|127.4|211.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||211.5|127.4|<0.0001
91691821|NCT01268527|183277970|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|246.6|||<|0.0001|TWO_SIDED|95.0|185.0|308.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||308.1|185.0|<0.0001
91722366|NCT00689936|183337121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.82903|TWO_SIDED|95.0|0.86|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.20|0.86|0.82903
91722367|NCT00689936|183337121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00119|TWO_SIDED|95.0|0.66|0.9||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.90|0.66|0.00119
91722368|NCT00689936|183337122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||<|1e-05|TWO_SIDED|95.0|1.41|2.37|||Fisher Exact|||||2.37|1.41|<0.00001
91722369|NCT00689936|183337122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.53065|TWO_SIDED|95.0|0.83|1.44|||Fisher Exact|||||1.44|0.83|0.53065
91527370|NCT00453479|182929953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.284|STANDARD_ERROR_OF_MEAN|0.3034|||TWO_SIDED|95.0|-0.314|0.882|||||Comparison of FVC, Day 7, 12 hour|||0.882|-0.314|
91722370|NCT00689936|183337122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.0001|TWO_SIDED|95.0|1.29|2.15|||Fisher Exact|||||2.15|1.29|0.00010
91722371|NCT00689936|183337123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||<|1e-05|TWO_SIDED|95.0|1.53|2.68|||Fisher Exact|||||2.68|1.53|<0.00001
91722372|NCT00689936|183337123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.405|TWO_SIDED|95.0|0.85|1.54|||Fisher Exact|||||1.54|0.85|0.40500
91722373|NCT00689936|183337123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||4e-05|TWO_SIDED|95.0|1.35|2.32|||Fisher Exact|||||2.32|1.35|0.00004
91722374|NCT00689936|183337124|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.51|0.76||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.76|0.51|<0.00001
91722375|NCT00689936|183337124|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|1e-05|TWO_SIDED|95.0|0.5|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.72|0.50|<0.00001
91722376|NCT00689936|183337124|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.7674|TWO_SIDED|95.0|0.86|1.23||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.23|0.86|0.76740
91722377|NCT00689936|183337125|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.51|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.51|<0.00001
91722378|NCT00689936|183337125|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.52|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.52|<0.00001
91691822|NCT01268527|183277970|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|132.3||||0.0043|TWO_SIDED|95.0|53.9|210.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||210.7|53.9|0.0043
91722379|NCT00689936|183337125|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99537|TWO_SIDED|95.0|0.85|1.17||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.17|0.85|0.99537
91722380|NCT00689936|183337126|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
91722381|NCT00689936|183337126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46672|||||||Wilcoxon (Mann-Whitney)|||||||0.46672
91722382|NCT00689936|183337126|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
91722383|NCT00689936|183337127|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
91691823|NCT01268527|183277970|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|145.0||||0.0036|TWO_SIDED|95.0|64.2|225.8|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM) and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||225.8|64.2|0.0036
91691824|NCT01268527|183277971|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|80.7||||0.0013|TWO_SIDED|95.0|34.6|126.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||126.7|34.6|0.0013
91691825|NCT01268527|183277971|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|127.9|||<|0.0001|TWO_SIDED|95.0|92.4|163.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.5|92.4|<0.0001
91691826|NCT01268527|183277971|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|110.2||||0.0458|TWO_SIDED|95.0|2.4|218.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||218.0|2.4|0.0458
91722384|NCT00689936|183337127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46987|||||||Wilcoxon (Mann-Whitney)|||||||0.46987
91722385|NCT00689936|183337127|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
91722386|NCT00689936|183337128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00012|TWO_SIDED|95.0|0.68|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.68|0.00012
91722387|NCT00689936|183337128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00187|TWO_SIDED|95.0|0.71|0.93||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.93|0.71|0.00187
91722388|NCT00689936|183337128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.45973|TWO_SIDED|95.0|0.84|1.08||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.08|0.84|0.45973
91722389|NCT00689936|183337129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||2e-05|TWO_SIDED|95.0|0.67|0.86||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.86|0.67|0.00002
91691827|NCT01268527|183277971|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|207.5|||<|0.0001|TWO_SIDED|95.0|155.2|259.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||259.9|155.2|<0.0001
91691828|NCT01268527|183277971|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|125.3||||0.0003|TWO_SIDED|95.0|71.5|179.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||179.0|71.5|0.0003
91722390|NCT00689936|183337129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00126|TWO_SIDED|95.0|0.72|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.72|0.00126
91722391|NCT00689936|183337129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.27704|TWO_SIDED|95.0|0.83|1.06||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.06|0.83|0.27704
91691829|NCT01268527|183277971|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|128.6||||0.0029|TWO_SIDED|95.0|93.9|163.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.3|93.9|0.0029
91691830|NCT01008605|183277976|SUPERIORITY_OR_OTHER||Lower limit, 95% one-sided CI|95.83|||||ONE_SIDED|95.0|87.46||||||||||87.46|
91691831|NCT03817190|183278039|SUPERIORITY||Proportion of participants|-0.2277||||0.688|TWO_SIDED|95.0|-1.0415|0.586|||GLMM|||||0.5860|-1.0415|0.6880
91722392|NCT00689936|183337130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|1e-05|TWO_SIDED|95.0|0.56|0.78||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.78|0.56|<0.00001
91722393|NCT00689936|183337130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.00067|TWO_SIDED|95.0|0.63|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.63|0.00067
91489380|NCT02484690|182851568|SUPERIORITY||Difference in Least Squares Means|-1.68||||0.3034|TWO_SIDED|80.0|-3.77|0.42||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that the Arm E mean was different from Arm A mean.||0.42|-3.77|0.3034
91489381|NCT02484690|182851569|SUPERIORITY||Difference in Least Squares Means|5.63||||0.5527|TWO_SIDED|80.0|-6.52|17.77||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||17.77|-6.52|0.5527
91691832|NCT03817190|183278040|SUPERIORITY||Proportion of participants|-0.276||||0.4321|TWO_SIDED|95.0|-0.9185|0.3665|||GLMM|||||0.3665|-0.9185|0.4321
91691833|NCT00868530|183278067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.120
91691834|NCT05142722|183278112|SUPERIORITY||Least Squares (LS) Means|-32.65|STANDARD_ERROR_OF_MEAN|1.602|<|0.0001|TWO_SIDED|95.0|-35.79|-29.5|||ANCOVA|||||-29.50|-35.79|<.0001
91691835|NCT05142722|183278113|SUPERIORITY||Least Squares (LS) Means|-33.78|STANDARD_ERROR_OF_MEAN|1.678|<|0.0001|TWO_SIDED|95.0|-37.07|-30.49|||ANCOVA|||||-30.49|-37.07|<.0001
91691836|NCT05142722|183278114|SUPERIORITY||Least Squares (LS) Means|-23.98|STANDARD_ERROR_OF_MEAN|1.979|<|0.0001|TWO_SIDED|95.0|-27.87|-20.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.09|-27.87|<.0001
91722394|NCT00689936|183337130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.12333|TWO_SIDED|95.0|0.75|1.03||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.03|0.75|0.12333
91722395|NCT00689936|183337131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.54|0.73||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||.73|0.54|<0.00001
91722396|NCT00689936|183337131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||1e-05|TWO_SIDED|95.0|0.61|0.83||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.83|0.61|0.00001
91722397|NCT00689936|183337131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.05821|TWO_SIDED|95.0|0.76|1.0||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.00|0.76|0.05821
91722398|NCT00689936|183337132|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.93824|TWO_SIDED|95.0|0.75|1.38|||Fisher Exact|||||1.38|0.75|0.93824
91722399|NCT00689936|183337132|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.08836|TWO_SIDED|95.0|0.56|1.03|||Fisher Exact|||||1.03|0.56|0.08836
91722400|NCT00689936|183337132|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.04974|TWO_SIDED|95.0|1.01|1.79|||Fisher Exact|||||1.79|1.01|0.04974
91722401|NCT00689936|183337133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.02134|TWO_SIDED|95.0|1.08|2.59|||Fisher Exact|||||2.59|1.08|0.02134
91722402|NCT00689936|183337133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.64|1.59|||Fisher Exact|||||1.59|0.64|1.00000
91722403|NCT00689936|183337133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.02374|TWO_SIDED|95.0|1.08|2.53|||Fisher Exact|||||2.53|1.08|0.02374
91691837|NCT05142722|183278115|SUPERIORITY||Least Squares (LS) Means|-18.92|STANDARD_ERROR_OF_MEAN|0.936|<|0.0001|TWO_SIDED|95.0|-20.76|-17.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-17.09|-20.76|<.0001
91691838|NCT05142722|183278116|SUPERIORITY||Least Squares (LS) Means|-18.31|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-20.38|-16.23||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-16.23|-20.38|<.0001
91691839|NCT05142722|183278117|SUPERIORITY||Least Squares (LS) Means|-13.8|STANDARD_ERROR_OF_MEAN|1.219|<|0.0001|TWO_SIDED|95.0|-16.2|-11.41||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-11.41|-16.20|<.0001
91691840|NCT05142722|183278118|SUPERIORITY||Least Squares (LS) Means|-29.44|STANDARD_ERROR_OF_MEAN|1.251|<|0.0001|TWO_SIDED|95.0|-31.89|-26.99||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.99|-31.89|<.0001
91691841|NCT05142722|183278119|SUPERIORITY||Least Squares (LS) Means|-28.32|STANDARD_ERROR_OF_MEAN|1.339|<|0.0001|TWO_SIDED|95.0|-30.94|-25.69||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-25.69|-30.94|<.0001
91691842|NCT05142722|183278120|SUPERIORITY||Least Squares (LS) Means|-23.02|STANDARD_ERROR_OF_MEAN|1.564|<|0.0001|TWO_SIDED|95.0|-26.09|-19.95||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.95|-26.09|<.0001
91691843|NCT05142722|183278121|SUPERIORITY||Least Squares (LS) Means|136.26|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|132.46|140.07||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||140.07|132.46|<.0001
91691844|NCT05142722|183278122|SUPERIORITY||Least Squares (LS) Means|134.43|STANDARD_ERROR_OF_MEAN|2.343|<|0.0001|TWO_SIDED|95.0|129.84|139.03||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||139.03|129.84|<.0001
91691845|NCT05142722|183278123|SUPERIORITY||Least Squares (LS) Means|122.04|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|95.0|117.53|126.55||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||126.55|117.53|<.0001
91691846|NCT05142722|183278124|SUPERIORITY||Least Squares (LS) Means|-14.12|STANDARD_ERROR_OF_MEAN|20.183||0.4841|TWO_SIDED|95.0|-53.68|25.44||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||25.44|-53.68|0.4841
91691847|NCT05161481|183278169|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-8.4|STANDARD_ERROR_OF_MEAN|8.9|||TWO_SIDED|95.0|-26.25|9.45||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||9.45|-26.25|
91691848|NCT05161481|183278169|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-14.18|STANDARD_ERROR_OF_MEAN|9.93|||TWO_SIDED|95.0|-34.09|5.72||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||5.72|-34.09|
91691849|NCT05161481|183278170|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|3.51|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|-8.94|15.96||||||The analysis of covariance (ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||15.96|-8.94|
91691850|NCT05161481|183278170|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|2.69|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-10.94|16.33||||||ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||16.33|-10.94|
91691851|NCT00838903|183278178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||||TWO_SIDED|95.0|-1.16|-0.65|||ANCOVA|||||-0.65|-1.16|
91722404|NCT00689936|183337134|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.11152|TWO_SIDED|95.0|0.91|3.21|||Fisher Exact|||||3.21|0.91|0.11152
91691852|NCT00838903|183278178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||||-0.17|-0.53|
91691853|NCT00838903|183278178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||||-0.09|-0.45|
91691854|NCT00838903|183278178|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is for superiority testing of albiglutide over placebo at 0.05 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero||||||<0.0001
91722405|NCT00689936|183337134|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.86336|TWO_SIDED|95.0|0.47|1.83|||Fisher Exact|||||1.83|0.47|0.86336
91691855|NCT00838903|183278178|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.|t-test, 1 sided|||||||<0.0001
91691856|NCT00838903|183278178|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.|t-test, 1 sided|||||||<0.0001
91691857|NCT00838903|183278178|SUPERIORITY_OR_OTHER|||||||0.0001||||||The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.||||||0.0001
91691858|NCT00838903|183278178|SUPERIORITY_OR_OTHER|||||||0.0033||||||The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.||||||0.0033
91691859|NCT04225715|183278187|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using Cochran-Mantel-Haenszel (CMH) method.|||16.4|-2.1|
91691860|NCT04225715|183278187|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|||10|-3.1|
91691861|NCT04225715|183278187|SUPERIORITY||Difference in Response Rate|24.3|||||TWO_SIDED|95.0|9.0|39.5|||||95% CI for difference of two proportions was calculated using CMH method.|||39.5|9|
91691862|NCT04225715|183278187|SUPERIORITY||Difference in Response Rate|12.3|||||TWO_SIDED|95.0|1.3|23.3|||||95% CI for difference of two proportions was calculated using CMH method.|||23.3|1.3|
91691863|NCT04225715|183278187|SUPERIORITY||Difference in Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||95% CI for difference of two proportions was calculated using CMH method.|||0|0|
91691864|NCT04225715|183278187|SUPERIORITY||Difference in Response Rate|6.7|||||TWO_SIDED|95.0|-2.2|15.7|||||95% CI for difference of two proportions was calculated using CMH method.|||15.7|-2.2|
91691865|NCT04225715|183278188|SUPERIORITY||6.2|6.2|||||TWO_SIDED|95.0|-2.0|14.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 7: Week 24||14.5|-2|
91691866|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|13.4|||||TWO_SIDED|95.0|1.2|25.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 8: Week 36||25.6|1.2|
91691867|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: Week 48||16.4|-2.1|
91691868|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: Week 48||10|-3.1|
91691869|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|31.2|||||TWO_SIDED|95.0|14.7|47.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: Week 48||47.6|14.7|
91691870|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|18.4|||||TWO_SIDED|95.0|5.4|31.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: Week 48||31.4|5.4|
91691871|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|8.1|||||TWO_SIDED|95.0|-3.9|20.1|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: FUW 48||20.1|-3.9|
91691872|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|-2.7|||||TWO_SIDED|95.0|-8.1|2.7|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: FUW 48||2.7|-8.1|
91691873|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|14.6|||||TWO_SIDED|95.0|0.4|28.8|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: FUW 48||28.8|0.4|
91691874|NCT04225715|183278188|SUPERIORITY||Difference in Response Rate|9.5|||||TWO_SIDED|95.0|-2.5|21.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: FUW 48||21.5|-2.5|
91691875|NCT01894841|183278207|SUPERIORITY||Partial eta squared|0.03||||0.13|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.13
91691876|NCT01894841|183278208|SUPERIORITY||Partial eta squared|0.01||||0.79|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.79
91691877|NCT01894841|183278209|SUPERIORITY||Partial eta squared|0.02||||0.49|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.49
91722406|NCT00689936|183337134|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07321|TWO_SIDED|95.0|0.96|3.55|||Fisher Exact|||||3.55|0.96|0.07321
91691878|NCT01894841|183278210|SUPERIORITY||Partial eta-squared|0.003||||0.96|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.96
91691879|NCT01894841|183278211|SUPERIORITY||Partial eta squared|0.01||||0.62|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.62
91691880|NCT03158038|183278218|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
91691881|NCT03158038|183278219|SUPERIORITY||Rate difference|1.3|||||TWO_SIDED|95.0|-12.8|13.2||||||Statistical analysis up to Day 8||13.2|-12.8|
91691882|NCT03158038|183278219|SUPERIORITY||Rate difference|0.4|||||TWO_SIDED|95.0|-14.1|13.2||||||Statistical analysis up to Day 15||13.2|-14.1|
91691883|NCT00925704|183278284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.171
91691884|NCT00925704|183278284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.024
91691885|NCT00925704|183278285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.313
91722407|NCT00689936|183337135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.62||||0.00043|TWO_SIDED|95.0|1.55|4.45|||Fisher Exact|||||4.45|1.55|0.00043
91722543|NCT02629159|183337905|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|7.5|||<|0.001|TWO_SIDED|95.0|3.0|12.1||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||12.1|3.0|<0.001
91722544|NCT02629159|183337905|SUPERIORITY||Response Rate Difference|-3.4||||0.187|TWO_SIDED|95.0|-8.2|1.5||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Adalimumab|||1.5|-8.2|0.187
91722545|NCT02629159|183337906|SUPERIORITY||Response Rate Difference|20.0|||<|0.001|TWO_SIDED|95.0|16.3|23.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||23.7|16.3|<0.001
91722546|NCT02629159|183337906|SUPERIORITY||Response Rate Difference|11.4|||<|0.001|TWO_SIDED|95.0|6.5|16.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.4|6.5|<0.001
91722547|NCT05722015|183337907|NON_INFERIORITY|Non-inferiority margin is 0.8.|Geometric Mean Ratio (GMR)|1.14|||<|1e-05|TWO_SIDED|96.0|1.06|1.22|||Welch's t test|One-sided p-value was calculated using the Welch's t test.|GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.|||1.22|1.06|<0.00001
91722548|NCT05722015|183337908|NON_INFERIORITY|Non-inferiority margin is 0.8.|GMR|1.67|||<|1e-05|TWO_SIDED|94.0|1.52|1.84|||Welch's t test|One sided p-value was calculated using Welch's t test.|GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.|||1.84|1.52|<0.00001
91722549|NCT02685735|183337923|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.882||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastophizing-optimism construct.||||0.882
91722550|NCT02685735|183337929|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.137||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastrophizing-optimism construct.||||0.137
91722551|NCT02685735|183337930|SUPERIORITY||||||<|0.0001|||||||Chi-squared|14 degrees of freedom||The null hypothesis (H0) is that modeled trajectory of change in pain intensity report after total hip or total knee arthroplasty does not differ between oral gabapentin and placebo in a manner dependent on its interaction with preferred cognitive style and pre-surgery pupil resting diameter . The alternative hypothesis (H1) is that there is a difference between the two groups which is dependent on these interactions.|A likelihood ratio test was conducted to compare these two models, conditional on the difference in the degrees of freedom in both models. A statistically significant likelihood ratio test would be interpreted as evidence that the three mechanistic predictors (Catastrophising-Optimism construct, Study Group, resting Pupil diameter) impact some aspect of the change in pain that occurs after surgery. If a statistically significant effect is observed, the individual interaction parameters will be interpreted.|||<0.0001
91722552|NCT04133909|183337931|SUPERIORITY||Rate ratio (Mepolizumab 100 mg/Placebo)|0.79||||0.011|TWO_SIDED|95.0|0.66|0.94|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (less than or equal to \[\<=\]2, 3, \>=4 as ordinal), baseline percent (%) predicted Forced expiratory volume in one second (FEV1) and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable.||0.94|0.66|0.011
91722553|NCT04133909|183337932|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.64|0.93|||Cox Proportional Hazards Model|||Estimated from a Cox Proportional Hazards Model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year \<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs former).||0.93|0.64|0.009
91722554|NCT04133909|183337933|SUPERIORITY||Odds Ratio (OR)|0.81||||0.161|TWO_SIDED|95.0|0.6|1.09|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.09|0.60|0.161
91759951|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.98|||||TWO_SIDED|95.0|-21.75|-6.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.21|-21.75|
91489425|NCT02555683|182851722|SUPERIORITY||rate ratio|0.96||||0.819|TWO_SIDED|95.0|0.75|1.22||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.22|0.75|0.819
91759952|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.45|||||TWO_SIDED|95.0|-0.53|13.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.42|-0.53|
91489426|NCT02555683|182851722|SUPERIORITY||Rate Ratio|0.78||||0.51|TWO_SIDED|95.0|0.61|1.01||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.01|0.61|0.510
91489427|NCT02555683|182851723|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.076||0.819|TWO_SIDED|95.0|-0.07|0.23||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.23|-0.07|0.819
91759953|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-5.81|7.92||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.92|-5.81|
91759954|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-6.25|7.57||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.57|-6.25|
91759955|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.42|||||TWO_SIDED|95.0|-9.26|4.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.42|-9.26|
91759956|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91|||||TWO_SIDED|95.0|1.48|16.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.35|1.48|
91759957|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.13|||||TWO_SIDED|95.0|-3.24|11.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.51|-3.24|
91692415|NCT03187301|183279693|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|7.5|17.1||||||2 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||17.1|7.5|
91692416|NCT03187301|183279693|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|6.1|15.7||||||3 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||15.7|6.1|
91692417|NCT03187301|183279693|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|4.2|13.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||13.8|4.2|
91692418|NCT02158585|183279701|SUPERIORITY||Mean Difference (Final Values)|8.93||||0.5618|TWO_SIDED|95.0|-3.49|21.35|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between groups in average total number of vertigo attacks||21.35|-3.49|0.5618
91692419|NCT02158585|183279702|SUPERIORITY|||||||0.03429|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between average total number of vertigo attacks in pre-treatment and treatment||||0.03429
91692420|NCT02158585|183279703|SUPERIORITY||Mean Difference (Net)|4.57||||0.0092|TWO_SIDED|95.0|0.85|8.29|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in total average number of vertigo attacks during 3 week time periods||8.29|0.85|0.0092
91722555|NCT04133909|183337934|SUPERIORITY||Odds Ratio (OR)|1.17||||0.291|TWO_SIDED|95.0|0.87|1.57|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.57|0.87|0.291
91722556|NCT04133909|183337935|SUPERIORITY||Odds Ratio (OR)|0.82||||0.209|TWO_SIDED|95.0|0.6|1.12|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.12|0.60|0.209
91692421|NCT02158585|183279706|SUPERIORITY||Median Difference (Final Values)|11.14||||0.0385|TWO_SIDED|95.0|-15.64|37.92|||Wilcoxon (Mann-Whitney)|||||37.92|-15.64|0.0385
91692422|NCT03809663|183279761|SUPERIORITY||Odds Ratio (OR)|1.686||||0.56|TWO_SIDED|95.0|0.29|9.809||Nominal p-value|Regression, Logistic|||||9.809|0.290|0.56
91759958|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-6.96|7.84||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.84|-6.96|
91759959|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-5.14|9.56||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.56|-5.14|
91692423|NCT03809663|183279761|SUPERIORITY||Odds Ratio (OR)|1.011||||0.99|TWO_SIDED|95.0|0.135|7.551||Nominal p-value|Regression, Logistic|||||7.551|0.135|0.99
91692424|NCT03809663|183279761|SUPERIORITY||Odds Ratio (OR)|2.146||||0.38|TWO_SIDED|95.0|0.39|11.8||Nominal p-value|Regression, Logistic|||||11.800|0.390|0.38
91692425|NCT03809663|183279762|SUPERIORITY||Odds Ratio (OR)|0.982||||0.97|TWO_SIDED|95.0|0.344|2.803||Nominal p-value|Regression, Logistic|||||2.803|0.344|0.97
91692426|NCT03809663|183279762|SUPERIORITY||Odds Ratio (OR)|1.217||||0.7|TWO_SIDED|95.0|0.441|3.356||Nominal p-value|Regression, Logistic|||||3.356|0.441|0.70
91692427|NCT03809663|183279762|SUPERIORITY||Odds Ratio (OR)|0.73||||0.58|TWO_SIDED|95.0|0.243|2.197||Nominal p-value|Regression, Logistic|||||2.197|0.243|0.58
91692428|NCT02792062|183279786|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|113.06||||0.659|TWO_SIDED|90.0|70.37|181.67|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||181.67|70.37|0.659
91692429|NCT02792062|183279786|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|45.43||||0.012|TWO_SIDED|90.0|27.86|74.07|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||74.07|27.86|0.012
91692430|NCT02792062|183279787|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.28||||0.238|TWO_SIDED|90.0|66.09|107.47|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||107.47|66.09|0.238
91722557|NCT04133909|183337936|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.65||||0.032|TWO_SIDED|95.0|0.43|0.96|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (\<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable. Estimates based on weighting applied to each level of class variable determined from observed proportions.||0.96|0.43|0.032
91692431|NCT02792062|183279787|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|53.2|||<|0.001|TWO_SIDED|90.0|41.39|68.37|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||68.37|41.39|<0.001
91692432|NCT02792062|183279788|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
91692433|NCT02792062|183279788|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
91692434|NCT02792062|183279789|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
91692435|NCT02792062|183279789|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
91692436|NCT03309943|183279796|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.019|||||||Mixed Models Analysis|Adjusted for FTCD. Carried out using SPSS Mixed Models with a repeated statement and compound symmetry covariance structure.||||||.019
91692437|NCT03309943|183279797|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.83|||||||Mixed Models Analysis|Adjusted for FTCD||||||.830
91692438|NCT03309943|183279798|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.006|||||||Mixed Models Analysis|||||||.006
91722558|NCT02003924|183337942|SUPERIORITY||Hazard Ratio (HR)|0.292|||<|0.0001|TWO_SIDED|95.0|0.241|0.352||P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.352|0.241|<0.0001
91758701|NCT00235716|183410637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.65||||0.14|TWO_SIDED|95.0|-3.12|-0.17||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.17|-3.12|0.14
91692439|NCT03309943|183279799|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.653|||||||Mixed Models Analysis|||||||.653
91692440|NCT03309943|183279800|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.012|||||||Mixed Models Analysis|Adjusted for FTCD||||||.012
91692441|NCT03309943|183279801|SUPERIORITY|Mixed model analysis examining the effects of drug condition on PPI indexes while viewing proximal smoking cues (which drove activation effects).||||||0.013|||||||Mixed Models Analysis|||||||.013
91692442|NCT03309943|183279802|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.024|||||||Repeated Measures ANCOVA|Adjusted for FTCD.||||||.024
91692443|NCT03309943|183279803|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.086|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.086
91692444|NCT03309943|183279804|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.14|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.140
91692445|NCT03309943|183279805|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for baseline craving and FTCD score).||||||0.556|||||||ANCOVA|Adjusted for baseline craving and FTCD score||||||.556
91692446|NCT03309943|183279806|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for FTCD score).||||||0.463||||||Adjusted for FTCD score only.|ANCOVA|||||||.463
91489428|NCT02555683|182851723|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.076||0.591|TWO_SIDED|95.0|-0.03|0.27||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.27|-0.03|0.591
91489429|NCT02555683|182851724|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.079||0.819|TWO_SIDED|95.0|-0.27|0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.04|-0.27|0.819
91489430|NCT02555683|182851724|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.079||0.591|TWO_SIDED|95.0|-0.35|-0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||-0.04|-0.35|0.591
91489431|NCT02555683|182851725|SUPERIORITY||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.0292||0.819|TWO_SIDED|95.0|0.019|0.134||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.134|0.019|0.819
91489432|NCT02555683|182851725|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.0292||0.591|TWO_SIDED|95.0|-0.017|0.097||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.097|-0.017|0.591
91722559|NCT02003924|183337943|SUPERIORITY||Hazard Ratio (HR)|0.066|||<|0.0001|TWO_SIDED|95.0|0.054|0.081||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.||0.081|0.054|<0.0001
91722560|NCT02003924|183337944|SUPERIORITY||Hazard Ratio (HR)|0.208|||<|0.0001|TWO_SIDED|95.0|0.168|0.258||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.||0.258|0.168|<0.0001
91722561|NCT02003924|183337945|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0011|TWO_SIDED|95.0|0.608|0.885||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.||0.885|0.608|0.0011
91722562|NCT02003924|183337946|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.6534|TWO_SIDED|95.0|0.801|1.149||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||1.149|0.801|0.6534
91722563|NCT02003924|183337947|SUPERIORITY||Hazard Ratio (HR)|0.378|||<|0.0001|TWO_SIDED|95.0|0.282|0.507||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.507|0.282|<0.0001
91722564|NCT02003924|183337950|SUPERIORITY||Difference in Response Rate|73.96|||<|0.0001|TWO_SIDED|95.0|70.91|77.02||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 50%||77.02|70.91|<0.0001
91722565|NCT02003924|183337950|SUPERIORITY||Difference in Response Rate|55.52|||<|0.0001|TWO_SIDED|95.0|52.28|58.76||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 90%||58.76|52.28|<0.0001
91527872|NCT00366301|182930722|SUPERIORITY_OR_OTHER||Percent Change in Log CRP|20.0|STANDARD_ERROR_OF_MEAN|10.0|<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Adjusted models included terms for baseline HbA1c and weight and change in weight at each time point.||As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. The means at each time point were estimated from a repeated-measures model incorporating all 3 time points. The interventions were assessed by fitting terms corresponding to study drug and treatment arm assignment.||||<0.05
91527873|NCT05952297|182930768|SUPERIORITY|||||||0.88|||||||mixed model|linear mixed model, time x condition effect||||||.88
91527874|NCT03959592|182930783|OTHER|||||||0.14|||||||Generalized Estimating Equations|||||||0.14
91722566|NCT02003924|183337950|SUPERIORITY||Difference in Response Rate|9.65|||<|0.0001|TWO_SIDED|95.0|7.75|11.54||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease to Undetectable Level||11.54|7.75|<0.0001
91722567|NCT01155570|183337996|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
91722568|NCT01155570|183337997|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 8||||<0.0001
91722569|NCT01155570|183337998|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
91722570|NCT01155570|183337999|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
91722571|NCT01155570|183338000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
91722572|NCT01155570|183338001|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
91722573|NCT01155570|183338006|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
91527875|NCT03959592|182930784|OTHER|||||||0.423|||||||Generalized Estimating Equations|||||||0.423
91527876|NCT03959592|182930787|OTHER|||||||0.985|||||||Generalized Estimating Equations|||||||0.985
91527877|NCT03959592|182930788|OTHER|||||||0.545|||||||Generalized Estimating Equations|||||||0.545
91527878|NCT04362137|182930790|SUPERIORITY||Odds Ratio (OR)|0.91||||0.769|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||1.73|0.48|0.769
91692447|NCT02230904|183279820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.115|STANDARD_DEVIATION|1.635|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
91692448|NCT02230904|183279827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442|STANDARD_DEVIATION|0.895|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
91692449|NCT02949973|183279880|OTHER||Percentage|70.0|||||TWO_SIDED|||||||||||||
91692450|NCT02949973|183279881|OTHER||Percentage|40.0|||||TWO_SIDED|||||||||||||
91692451|NCT02949973|183279882|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
91692452|NCT02949973|183279883|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
91692453|NCT02949973|183279884|OTHER||Percentage|70.0|||||TWO_SIDED|95.0|34.8|93.3||||||||93.3|34.8|
91692454|NCT02949973|183279885|OTHER||Percentage|50.0|||||TWO_SIDED|95.0|15.7|84.3||||||||84.3|15.7|
91722574|NCT01155570|183338007|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
91722575|NCT01155570|183338008|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
91722576|NCT01155570|183338009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
91527879|NCT04362137|182930792|SUPERIORITY||Odds Ratio (OR)|0.89||||0.647|TWO_SIDED|95.0|0.55|1.46|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.46|0.55|0.647
91692455|NCT01420068|183279886|SUPERIORITY||Mean Difference (Net)|0.31||||0.84|TWO_SIDED|95.0|-2.74|3.37||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline weight as covariates.||||3.37|-2.74|0.840
91692456|NCT01420068|183279887|SUPERIORITY||Mean Difference (Net)|0.69||||0.303|TWO_SIDED|95.0|-0.63|2.02||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline height as covariates.||||2.02|-0.63|0.303
91692457|NCT01420068|183279888|SUPERIORITY||Mean Difference (Net)|0.03||||0.957|TWO_SIDED|95.0|-1.06|1.12||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline BMI as covariates.||||1.12|-1.06|0.957
91692458|NCT01420068|183279890|SUPERIORITY||Mean Difference (Net)|0.02||||0.992|TWO_SIDED|95.0|-3.29|3.33||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||3.33|-3.29|0.992
91692459|NCT01420068|183279890|SUPERIORITY||Mean Difference (Net)|-3.06||||0.215|TWO_SIDED|95.0|-8.22|2.1||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||2.10|-8.22|0.215
91692460|NCT01420068|183279891|SUPERIORITY||Mean Difference (Net)|0.62||||0.403|TWO_SIDED|95.0|-0.85|2.09||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||2.09|-0.85|0.403
91692461|NCT01420068|183279891|SUPERIORITY||Mean Difference (Net)|0.92||||0.67|TWO_SIDED|95.0|-3.74|5.57||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||5.57|-3.74|0.670
91692462|NCT01420068|183279892|SUPERIORITY||Mean Difference (Net)|-0.11||||0.86|TWO_SIDED|95.0|-1.29|1.08||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||1.08|-1.29|0.860
91692463|NCT01420068|183279892|SUPERIORITY||Mean Difference (Net)|-1.17||||0.32|TWO_SIDED|95.0|-3.66|1.32||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||1.32|-3.66|0.320
91692464|NCT00365794|183279895|OTHER|||||||0.77|||||||t-test, 2 sided|||Total body mass||||0.77
91692465|NCT00365794|183279895|OTHER|||||||0.003|||||||t-test, 2 sided|||Total fat mass||||0.003
91692466|NCT00365794|183279895|OTHER|||||||0.0007|||||||t-test, 2 sided|||Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.||||0.0007
91692467|NCT00365794|183279895|OTHER|||||||0.01|||||||t-test, 2 sided|||Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.||||0.01
91692468|NCT00365794|183279896|OTHER|||||||0.12||||||No adjustment in p for multiple comparisons.|t-test, 2 sided|||||||0.12
91692469|NCT00365794|183279897|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
91692470|NCT00365794|183279898|OTHER|||||||0.0002||||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||0.0002
91692471|NCT00365794|183279899|OTHER|||||||0.04|||||||t-test, 2 sided|||Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.||||0.04
91692472|NCT00365794|183279899|OTHER|||||||0.59|||||||t-test, 2 sided|||Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.59
91692473|NCT00365794|183279899|OTHER|||||||0.03|||||||t-test, 2 sided|||Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.03
91692474|NCT00365794|183279900|OTHER|||||||0.0006|||||||t-test, 2 sided|||Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.||||0.0006
91722577|NCT01155570|183338011|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
91722578|NCT01155570|183338012|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
91722579|NCT01155570|183338013|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
91722580|NCT01155570|183338014|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
91722581|NCT01155570|183338015|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
91692475|NCT00365794|183279901|OTHER|Test for fasting triglycerides||||||0.02|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.||||0.02
91692476|NCT00365794|183279901|OTHER|Test for total cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
91692477|NCT00365794|183279901|OTHER|Test for LDL cholesterol||||||0.02|||||||t-test, 2 sided|||nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||.02
91692478|NCT00365794|183279901|OTHER|Test for HDL cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
91692479|NCT00365794|183279902|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
91692480|NCT00365794|183279903|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
91692481|NCT00365794|183279904|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
91692482|NCT04760626|183279907|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec with doseguide minus once daily basal insulin analogue) was strictly below 0.3 percent point.|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.09|||ANCOVA|||The response and change from baseline in response after 52 weeks were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors, and baseline HbA1c as a covariate.||-0.09|-0.66|<0.0001
91722582|NCT01155570|183338016|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
91722583|NCT01155570|183338017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
91722584|NCT01922934|183338018|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91722585|NCT02354118|183338026|NON_INFERIORITY|10% non-inferiority margin||||||1|||||||Chi-squared|||||||1.0
91692483|NCT02554682|183279916|SUPERIORITY|||||||0.906|||||||Generalized Linear Model|||||||.906
91692484|NCT02554682|183279916|SUPERIORITY|||||||0.796|||||||Generalized Linear Model|||||||.796
91692485|NCT02554682|183279916|SUPERIORITY|||||||0.886|||||||Generalized Linear Model|||||||.886
91692486|NCT02554682|183279916|OTHER|||||||0.082|||||||Generalized Linear Model|||||||.082
91692487|NCT02554682|183279917|SUPERIORITY|||||||0.677|||||||Generalized Linear Model|||||||0.677
91692488|NCT02554682|183279917|SUPERIORITY|||||||0.02|||||||Generalized Linear Model|||||||0.020
91692489|NCT02554682|183279917|SUPERIORITY|||||||0.952|||||||Generalized Linear Model|||||||.952
91692490|NCT02554682|183279917|SUPERIORITY|||||||0.21|||||||Generalized Linear Model|||||||0.210
91692491|NCT02554682|183279918|SUPERIORITY|||||||0.505|||||||Generalized Linear Model|||||||0.505
91692492|NCT02554682|183279918|SUPERIORITY|||||||0.176|||||||Generalized Linear Model|||||||.176
91692493|NCT02554682|183279918|SUPERIORITY|||||||0.134|||||||Generalized Linear Model|||||||0.134
91692494|NCT02554682|183279918|SUPERIORITY|||||||0.029|||||||Generalized Linear Model|||||||0.029
91692495|NCT02554682|183279919|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||.037
91692496|NCT02554682|183279920|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
91692497|NCT02554682|183279921|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91692498|NCT02554682|183279922|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||.571
91692499|NCT02554682|183279923|SUPERIORITY|||||||0.394|||||||t-test, 2 sided|||||||.394
91692500|NCT02554682|183279924|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||.008
91692501|NCT02554682|183279925|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91692502|NCT02554682|183279926|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
91692503|NCT02554682|183279927|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||.159
91692504|NCT02554682|183279928|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||.112
91692505|NCT02554682|183279929|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||.165
91692506|NCT02554682|183279930|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
91692507|NCT00758290|183279931|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
91692508|NCT00884117|183279942|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<0.0001
91692509|NCT00884117|183279942|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
91692510|NCT00884117|183279942|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
91692511|NCT00884117|183279943|SUPERIORITY_OR_OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
91692512|NCT00884117|183279943|SUPERIORITY_OR_OTHER|||||||0.009|||||||Pairwise Wilcoxon|||||||0.009
91692513|NCT00884117|183279943|SUPERIORITY_OR_OTHER|||||||0.03|||||||Pairwise Wilcoxon|||||||0.03
91692514|NCT00884117|183279944|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Kruskal-Wallis|||||||0.0005
91692515|NCT00884117|183279944|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
91692516|NCT00884117|183279944|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
91692517|NCT00884117|183279945|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
91692518|NCT00884117|183279945|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
91692519|NCT00884117|183279945|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
91692520|NCT00884117|183279948|SUPERIORITY_OR_OTHER|||||||0.4464|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.4464
91692521|NCT00884117|183279949|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||<0.0001
91722586|NCT02774889|183338027|SUPERIORITY||Rate Ratio|0.72||||0.55|TWO_SIDED|95.0|0.27|2.57|||Fisher Exact|||||2.57|0.27|0.55
91722587|NCT02774889|183338028|SUPERIORITY||Mean Difference (Final Values)|-4.74||||0.001|TWO_SIDED|95.0|-6.61|-2.89|||Fisher Exact|||at 3 months||-2.89|-6.61|0.001
91722588|NCT02774889|183338028|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.001|TWO_SIDED|95.0|-6.47|-1.68|||Fisher Exact|||at 6 months||-1.68|-6.47|0.001
91722589|NCT02774889|183338029|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.05|TWO_SIDED|95.0|0.0|0.16|||Fisher Exact|||3 months||0.16|0.00|0.05
91722590|NCT02774889|183338029|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0003|TWO_SIDED|95.0|0.07|0.22|||Fisher Exact|||6 months||0.22|0.07|0.0003
91722591|NCT02774889|183338030|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.44|||Fisher Exact|||3 months||0.44|-0.40|0.88
91489410|NCT02569671|182851631|NON_INFERIORITY|"is less than the non-inferiority margin (indicating non-inferior bone gain).~The hypotheses associated with the primary analysis are defined as:~H0: µc - µs ≥ δ H1: µc - µs \< δ where µc is the mean change in crestal bone levels from implant loading to 12 months post-implant loading for the treatment group, µs is the mean change for the control group, and δ is the 0.5 mm non-inferiority margin. The hypotheses will be tested using a one-sided t-test with a 5% significance level."|Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5||0.95|ONE_SIDED|95.0||||SD for both test and control group is 0.5 mm, A difference between groups of ≥ 0.5 mm is considered clinically significant, The difference between the treatment groups is expected to be 0 mm, Statistical test will be one-sided 5% significance level.|t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The null hypothesis for the primary analysis is that the difference between the mean change in crestal bone levels for the treatment and control groups is at least the non-inferiority margin (indicating inferior bone gain). Rejection of the null hypothesis indicates the observed data supports the alternative hypothesis that the difference between the mean change in crestal bone levels for the treatment and control groups|The change in mean bone level from implant loading to 12-month follow-up was calculated. Change in crestal bone levels was calculated as the crestal bone level at 12-months post implant loading minus crestal bone level at implant loading.|||.950
91489411|NCT02569671|182851633|NON_INFERIORITY|Smaller bone dimensional thickness of the buccal plate measurements indicates less bone loss and better healing.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.3||0.022|ONE_SIDED|95.0|||||t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.||All secondary effectiveness endpoints were planned to be summarized descriptively, and no hypothesis tests was planned.||||0.022
91489412|NCT01757535|182851640|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0009|TWO_SIDED|95.0|0.55|0.86||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.||The confidence interval (CI) for the difference was derived using Kosorok's method.|0.86|0.55|0.0009
91489413|NCT01757535|182851641|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.52|0.8||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.|||0.80|0.52|< 0.0001
91489414|NCT01757535|182851647|SUPERIORITY||Hazard Ratio (HR)|0.9345||||0.7522|TWO_SIDED|95.0|0.6136|1.4231||Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no|Regression, Cox|||||1.4231|0.6136|0.7522
91489415|NCT04508335|182851653|EQUIVALENCE|We use 2, one-sided t-tests, each with alpha set at 0.05 to test the composite null hypothesis that the mean difference score (μReia-μCurrent) between the Reia pessary and baseline (current pessary) on the PFDI-20, is greater than 18.3 (H01), the upper equivalence limit, or lower than -18.3 (H02), the lower equivalence limit.||||||0.0021|||||||t-test, 2 sided|||H01: μReia-μCurrent \> 18.3 and H02: μReia-μCurrent \< -18.3. The alternative hypothesis is thus: HA: -18.3 ≤ μReia-μCurrent ≤ 18.3.||||.0021
91489416|NCT04508335|182851655|OTHER|Mean difference of PFIQ scores. A negative difference (Reia pessary - current pessary) indicates that the PFIQ-7 score improved with the Reia pessary.|Mean Difference (Final Values)|-11.9||||0.0192|TWO_SIDED|||||p value adjusted for multiple variables|Wilcoxon (Mann-Whitney)|||PFIQ scores at baseline with subjects using current pessary then after treatment with Reia pessary||||0.0192
91489417|NCT02555683|182851718|SUPERIORITY||rate ratio|1.04||||0.8|TWO_SIDED|95.0|0.77|1.41||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.41|0.77|0.800
91722592|NCT02774889|183338030|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.83|TWO_SIDED|95.0|-0.48|0.37|||Fisher Exact|||6 months||0.37|-0.48|0.83
91489418|NCT02555683|182851718|SUPERIORITY||Rate Ratio|0.83||||0.51|TWO_SIDED|95.0|0.61|1.14||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.14|0.61|0.510
91489419|NCT02555683|182851719|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.095||0.819|TWO_SIDED|95.0|-0.11|0.26||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.26|-0.11|0.819
91489420|NCT02555683|182851719|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.095||0.591|TWO_SIDED|95.0|-0.05|0.32||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.32|-0.05|0.591
91489421|NCT02555683|182851720|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.098||0.819|TWO_SIDED|95.0|-0.31|0.07||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.07|-0.31|0.819
91489422|NCT02555683|182851720|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.098||0.591|TWO_SIDED|95.0|-0.37|0.02||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.02|-0.37|0.591
91489423|NCT02555683|182851721|SUPERIORITY||Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.0365||0.8|TWO_SIDED|95.0|-0.005|0.139||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.139|-0.005|0.800
91489424|NCT02555683|182851721|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0363||0.523|TWO_SIDED|95.0|-0.021|0.121||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.121|-0.021|0.523
91722593|NCT02774889|183338031|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.36|TWO_SIDED|95.0|-0.2|0.54|||Fisher Exact|||3 months||0.54|-0.20|0.36
91722594|NCT02774889|183338031|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.14|TWO_SIDED|95.0|-0.11|0.77|||Fisher Exact|||6 months||0.77|-0.11|0.14
91722595|NCT02774889|183338032|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.52|TWO_SIDED|95.0|-0.43|0.85|||Fisher Exact|||3 months||0.85|-0.43|0.52
91722596|NCT02774889|183338032|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.36|TWO_SIDED|95.0|-0.31|0.85|||Fisher Exact|||6 months||0.85|-0.31|0.36
91692522|NCT00884117|183279950|SUPERIORITY_OR_OTHER|||||||0.2499|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.2499
91692523|NCT02946463|183279957|NON_INFERIORITY|LDH-N was analyzed using a generalized estimating equation (GEE) approach. The model included the following terms: treatment group, history of transfusion (as a categorical variable based on the stratification factor levels), and baseline LDH level (as a continuous variable). Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the odds ratio (OR) of ravulizumab versus eculizumab for LDH normalization being greater than an OR of 0.39.|Odds Ratio (OR)|1.187|||||TWO_SIDED|95.0|0.796|1.769||||||A minimum of 142 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab.||1.769|0.796|
91692524|NCT02946463|183279958|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|6.8|||||TWO_SIDED|95.0|-4.66|18.14|||||Treatment difference was estimated for ravulizumab - eculizumab.|A minimum of 193 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab. The difference of percentages were calculated using stratified Newcombe CI method. Stratification factors were: observed stratification groups of packed red blood cells (pRBC)/whole blood units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||18.14|-4.66|
91692525|NCT02946463|183279959|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-6.7|||||TWO_SIDED|95.0|-14.21|0.18|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||0.18|-14.21|
91692526|NCT02946463|183279960|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-0.83|||||TWO_SIDED|95.0|-5.21|3.56|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.56|-5.21|
91692527|NCT02946463|183279961|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -5%.|Treatment difference|0.67|||||TWO_SIDED|95.0|-1.21|2.55|||||Treatment difference was estimated for ravulizumab - eculizumab.|||2.55|-1.21|
91692528|NCT02946463|183279962|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|2.9|||||TWO_SIDED|95.0|-8.8|14.64|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||14.64|-8.80|
91722597|NCT02774889|183338033|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.43|TWO_SIDED|95.0|-0.58|1.32|||Fisher Exact|||3 months||1.32|-0.58|0.43
91722598|NCT02774889|183338033|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.26|TWO_SIDED|95.0|-0.42|1.49|||Fisher Exact|||6 months||1.49|-0.42|0.26
91722599|NCT02774889|183338034|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.16|TWO_SIDED|95.0|-0.09|0.61|||Fisher Exact|||3 months||0.61|-0.09|0.16
91722600|NCT02774889|183338034|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.29|TWO_SIDED|95.0|-0.55|0.17|||Fisher Exact|||6 months||0.17|-0.55|0.29
91722601|NCT02774889|183338036|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.91|TWO_SIDED|95.0|-2.66|2.4|||Fisher Exact|||3 months||2.40|-2.66|0.91
91722602|NCT02774889|183338036|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.8|TWO_SIDED|95.0|-2.79|2.15|||Fisher Exact|||6 months||2.15|-2.79|0.80
91722603|NCT02774889|183338037|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.54|TWO_SIDED|95.0|-1.44|2.64|||Fisher Exact|||3 months||2.64|-1.44|0.54
91692529|NCT00122382|183279982|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.1|||<|0.001|TWO_SIDED|95.0|6.0|24.2||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving an ACR 50 response.||24.2|6.0|<0.001
91692530|NCT00122382|183279983|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.5|||<|0.001|TWO_SIDED|95.0|8.2|22.8||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving MCR.||22.8|8.2|<0.001
91722604|NCT02774889|183338037|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.38|TWO_SIDED|95.0|-1.49|3.81|||Fisher Exact|||6 months||3.81|-1.49|0.38
91722605|NCT02774889|183338039|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.04|TWO_SIDED|95.0|0.06|3.71|||Fisher Exact|||Inside Balance||3.71|0.06|0.04
91722606|NCT02774889|183338039|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.05|TWO_SIDED|95.0|-0.02|3.51|||Fisher Exact|||Outside Balance||3.51|-0.02|0.05
91722607|NCT02774889|183338039|SUPERIORITY||Mean Difference (Final Values)|1.86||||0.06|TWO_SIDED|95.0|-0.08|3.81|||Fisher Exact|||Strength||3.81|-0.08|0.06
91722608|NCT02774889|183338040|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.003|TWO_SIDED|95.0|0.54|2.17|||Fisher Exact|||Balance Exercises at 3 months||2.17|0.54|0.003
91722609|NCT02774889|183338040|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.11|TWO_SIDED|95.0|-0.22|2.24|||Fisher Exact|||Balance Exercises at 6 Months||2.24|-0.22|0.11
91722610|NCT02774889|183338041|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.01|TWO_SIDED|95.0|0.23|1.89|||Fisher Exact|||Strength Exercises at 3 months||1.89|0.23|0.01
91722611|NCT02774889|183338041|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.16|1.67|||Fisher Exact|||Strength Exercises at 6 months||1.67|-0.16|0.11
91722612|NCT02774889|183338042|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.38|TWO_SIDED|95.0|-1.3|3.3|||Fisher Exact|||3 months||3.30|-1.30|0.38
91692531|NCT00122382|183279984|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.98|-0.48||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||||-0.48|-0.98|<0.001
91722613|NCT02774889|183338042|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.02|TWO_SIDED|95.0|0.43|4.73|||Fisher Exact|||6 months||4.73|0.43|0.02
91722614|NCT02774889|183338043|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.33|TWO_SIDED|95.0|-0.33|0.97|||Fisher Exact|||3 months||0.97|-0.33|0.33
91722615|NCT02774889|183338043|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.06|TWO_SIDED|95.0|-0.02|1.27|||Fisher Exact|||6 months||1.27|-0.02|0.06
91722616|NCT02774889|183338044|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.06|TWO_SIDED|95.0|-0.03|1.28|||Fisher Exact|||3 months||1.28|-0.03|0.06
91722617|NCT02774889|183338044|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.59|TWO_SIDED|95.0|-0.45|0.81|||Fisher Exact|||||0.81|-0.45|0.59
91722618|NCT01069939|183338045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.09|||<|0.001|TWO_SIDED|96.65|0.02|0.41||An interim analysis was done so that the significance level was adjusted using the Pocock-like alpha-spending function with Lan-DeMets approach. The adjusted significance level was the two-sided 3.35%.|Log Rank|||The above two groups were compared.||0.41|0.02|<0.001
91722619|NCT00724945|183338055|SUPERIORITY_OR_OTHER||Least Square Mean|-0.08591|STANDARD_ERROR_OF_MEAN|0.008816||||95.0|-0.08591|-0.06857|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.||-0.06857|-0.08591|
91722620|NCT00724945|183338056|SUPERIORITY_OR_OTHER||Least Square Mean|0.02711|STANDARD_ERROR_OF_MEAN|0.008816||||97.5|0.02711|0.04445|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.||0.04445|0.02711|
91722621|NCT00724945|183338057|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -0.5.|Mean Difference (Final Values)|0.07407|STANDARD_ERROR_OF_MEAN|0.1279||||97.5|-0.1797|0.07407|||Mixed Models Analysis||Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.|Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.||0.07407|-0.1797|
91722622|NCT04901624|183338067|SUPERIORITY||Slope|1.19|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|0.42|1.97|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Personal + Loss Protection relative to reference group (Personal + Lottery).|||1.97|0.42|0.003
91722623|NCT04901624|183338067|SUPERIORITY||Slope|1.46|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.68|2.24|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Loss Protection relative to reference group (Personal + Lottery).|||2.24|0.68|<0.001
91722624|NCT04901624|183338067|SUPERIORITY||Slope|1.11|STANDARD_ERROR_OF_MEAN|0.44||0.01|TWO_SIDED|95.0|0.26|1.96|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Lottery relative to reference group (Personal + Lottery).|||1.96|0.26|0.01
91722625|NCT04901624|183338068|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.35||0.409|TWO_SIDED|95.0|-0.98|0.4|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.4|-0.98|0.409
91489433|NCT04622306|182851734|NON_INFERIORITY|The non-inferiority margin for the difference in total clinical failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified in ISO 23409:2011 as 2.5%.|Upper 97.5% CL for difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Expected test condom total clinical failure rate - expected control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
91527880|NCT04362137|182930792|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.52|1.92|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.92|0.52|0.997
91692532|NCT00122382|183279985|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|9.8||||0.024|TWO_SIDED|95.0|1.3|18.4||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving HAQ response.||18.4|1.3|0.024
91692533|NCT00122382|183279986|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|2.5||||0.005|TWO_SIDED|95.0|0.77|4.23||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||PCS Adjusted Mean Change from Baseline to Month 12||4.23|0.77|0.005
91692534|NCT00122382|183279986|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|1.81||||0.046|TWO_SIDED|95.0|0.03|3.6||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||MCS Adjusted Mean Change from Baseline to Month 12||3.60|0.03|0.046
91722626|NCT04901624|183338068|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.098|TWO_SIDED|95.0|-0.09|1.1|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||1.10|-0.09|0.098
91722627|NCT04901624|183338068|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.982|TWO_SIDED|95.0|-0.71|0.73|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.73|-0.71|0.982
91722628|NCT04901624|183338068|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.177|TWO_SIDED|95.0|-0.67|0.12|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.12|-0.67|0.177
91722629|NCT04901624|183338068|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.21||0.117|TWO_SIDED|95.0|-0.08|0.74|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.74|-0.08|0.117
91722630|NCT04901624|183338068|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.23||0.809|TWO_SIDED|95.0|-0.39|0.5|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.50|-0.39|0.809
91722631|NCT04901624|183338068|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.19||0.847|TWO_SIDED|95.0|-0.34|0.41|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.41|-0.34|0.847
91722632|NCT04901624|183338068|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.2||0.993|TWO_SIDED|95.0|-0.39|0.38|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.38|-0.39|0.993
91722633|NCT04901624|183338068|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.22||0.671|TWO_SIDED|95.0|-0.51|0.33|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.33|-0.51|0.671
91722634|NCT01147458|183338079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
91722635|NCT01147458|183338079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
91692535|NCT00122382|183279987|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in erosion scores between abatacept and placebo||||0.033
91692536|NCT00122382|183279987|SUPERIORITY_OR_OTHER|||||||0.353||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in JSN scores between abatacept and placebo||||0.353
91692537|NCT00122382|183279989|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|18.1|||<|0.001|TWO_SIDED|95.0|9.6|26.6||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving DAS28-CRP remission.||26.6|9.6|<0.001
91722636|NCT01147458|183338080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
91527881|NCT04362137|182930793|SUPERIORITY||Odds Ratio (OR)|0.98||||0.946|TWO_SIDED|95.0|0.51|1.87|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.87|0.51|0.946
91692538|NCT00122382|183279990|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|non-parametric ANCOVA|||||||<0.040
91692539|NCT00122382|183280005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||signed rank test|||||||<0.001
91692540|NCT02040805|183280008|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 5 points.||||||0.04|||||||t-test, 1 sided|||Test of non-inferiority.||||0.04
91692541|NCT02040805|183280009|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 2.5 points.||||||0.05|||||||t-test, 1 sided|||Test of non-inferiority.||||0.05
91692542|NCT02040805|183280010|OTHER|linear mixed models analysis|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
91692543|NCT02040805|183280011|OTHER|linear mixed model|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
91692544|NCT00908544|183280013|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.98
91692545|NCT00908544|183280013|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-1.7|-1.1|||t-test, 1 sided|||||-1.1|-1.7|<0.01
91692546|NCT00908544|183280013|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|0.12||||0.93|TWO_SIDED|95.0|-0.1|0.3|||t-test, 1 sided|||||0.3|-0.1|0.93
91692547|NCT00908544|183280013|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|-1.3|||<|0.01|TWO_SIDED|95.0|-1.6|-1.0|||t-test, 1 sided|||||-1.0|-1.6|<0.01
91527882|NCT04362137|182930793|SUPERIORITY||Odds Ratio (OR)|0.79||||0.573|TWO_SIDED|95.0|0.35|1.79|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.79|0.35|0.573
91692548|NCT00908544|183280014|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|0.2||||0.99|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.99
91692549|NCT00908544|183280014|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.5|||t-test, 1 sided|||||-1.5|-2.0|<0.01
91692550|NCT00908544|183280014|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|0.2||||0.97|TWO_SIDED|95.0|0.0|0.3|||t-test, 1 sided|||||0.3|-0.0|0.97
91692551|NCT00908544|183280014|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.4|||t-test, 1 sided|||||-1.4|-2.0|<0.01
91692552|NCT00833105|183280067|SUPERIORITY_OR_OTHER||||||<|0.025|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||<0.025
91692553|NCT00833105|183280068|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.299
91692554|NCT00833105|183280069|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.459
91692555|NCT00833105|183280070|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.343
91692556|NCT00833105|183280071|SUPERIORITY_OR_OTHER|||||||0.951|TWO_SIDED||||||Mixed Models Analysis|Random subject effects||||||0.951
91692557|NCT00833105|183280072|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.371
91692558|NCT00833105|183280073|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.164
91692559|NCT00833105|183280074|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon Signed-Rank|No multiple comparison procedure||Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.||||<0.01
91692560|NCT00833105|183280075|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||No multiple comparison procedure performed|Wilcoxon Signed Rank Test|||||||<0.05
91692561|NCT00833105|183280076|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||No multiple comparison procedure|Wilcoxon Signed Rank Test|||||||<0.0001
91692562|NCT00833105|183280077|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.005
91692563|NCT00833105|183280078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
91692564|NCT00833105|183280079|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparisons adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
91692565|NCT02898597|183280080|SUPERIORITY||Odds Ratio (OR)|12.31|||<|0.05|TWO_SIDED|95.0|1.37|110.3|||Regression, Logistic|||||110.30|1.37|< 0.05
91513225|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.70|0.51|
91692566|NCT02898597|183280080|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).||||<0.05
91722637|NCT01147458|183338080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
91722638|NCT01147458|183338081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|80.0|-0.15|0.29|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.29|-0.15|
91722639|NCT01147458|183338081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|80.0|-0.09|0.35|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.35|-0.09|
91722640|NCT01147458|183338082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|1.239|||TWO_SIDED|80.0|-0.34|2.85|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||2.85|-0.34|
91722641|NCT01147458|183338082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.252|||TWO_SIDED|80.0|-1.95|1.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.28|-1.95|
91722642|NCT01147458|183338083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.06|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|80.0|-0.13|4.25|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||4.25|-0.13|
91722643|NCT01147458|183338083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|80.0|-2.53|1.88|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.88|-2.53|
91722644|NCT01147458|183338084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|0.624|||TWO_SIDED|80.0|-0.03|1.58|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.58|-0.03|
91722645|NCT01147458|183338084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|80.0|-0.97|0.65|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.65|-0.97|
91722646|NCT01147458|183338085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|80.0|-0.18|0.2|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.20|-0.18|
91692567|NCT00343044|183280269|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Planned enrollment of 40 patients was determined assuming a median progression free survival (PFS) of 9 months (based on a median PFS of 7.2 months for low-dose, metronomic cyclophosphamide plus bevacizumab in a phase 2 study) and an analysis calculating the sample size at which the narrowing of its 95% confidence interval (CI) became greater than .2 for every 2 patients added. Progression free survival was estimated using the Kaplan-Meier method.||||.08
91722647|NCT01147458|183338085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|80.0|-0.07|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.07|
91722648|NCT01147458|183338086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|80.0|-0.12|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.12|
91722649|NCT01147458|183338086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|80.0|-0.11|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.11|
91722650|NCT02811159|183338102|OTHER|||||||0.1797|||||||Chi-Square Test|||||||0.1797
91722651|NCT02811159|183338103|OTHER|||||||0.125|||||||Wilcoxon Signed-Rank Test|||||||0.1250
91692568|NCT00343044|183280270|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Overall survival(OS)was estimated using the Kaplan-Meier method.||||.02
91692569|NCT01511978|183280273|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91722652|NCT02811159|183338104|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
91722653|NCT02811159|183338105|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
91722654|NCT02811159|183338106|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
91722655|NCT02811159|183338107|OTHER|||||||1|||||||Wilcoxon Signed-Rank Test|||||||1.0000
91722656|NCT02811159|183338108|OTHER|||||||0.875|||||||Wilcoxon Signed-Rank Test|||||||0.8750
91722657|NCT02811159|183338109|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
91692570|NCT01511978|183280274|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91527883|NCT04362137|182930794|SUPERIORITY||Odds Ratio (OR)|0.75||||0.532|TWO_SIDED|95.0|0.31|1.83|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||1.83|0.31|0.532
91692571|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Adjusted GMT/GMT Ratio based on analysis of covariance (ANCOVA) model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.18|0.87|
91692572|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|0.96|||||TWO_SIDED|95.0|0.82|1.12|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.12|0.82|
91692573|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.1|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.10|0.81|
91692574|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.13|0.77|
91692575|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.32|0.91|
91692576|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.41|0.97|
91692577|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.15|0.87|
91692578|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
91722658|NCT02811159|183338110|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
91722659|NCT02811159|183338111|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
91722660|NCT02811159|183338112|OTHER|||||||0.0645|||||||Wilcoxon Signed-Rank Test|||||||0.0645
91722661|NCT04603066|183338114|SUPERIORITY||Mean Difference (Final Values)|0.0204257||||0.8651|TWO_SIDED|95.0|-0.2624635|0.2216122|||t-test, 2 sided|||||0.2216122|-0.2624635|0.8651
91527884|NCT04362137|182930794|SUPERIORITY||Odds Ratio (OR)|1.18||||0.764|TWO_SIDED|95.0|0.4|3.49|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||3.49|0.40|0.764
91692579|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
91692580|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.09|0.80|
91692581|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|0.91|||||TWO_SIDED|95.0|0.78|1.07|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.07|0.78|
91692582|NCT03321968|183280275|SUPERIORITY||Adjusted GMT Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.15|0.84|
91692583|NCT02282813|183280293|SUPERIORITY_OR_OTHER|||||||0.1041|||||||Cochran-Mantel-Haenszel|||||||0.1041
91692584|NCT02282813|183280294|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Cochran-Mantel-Haenszel|||||||.0503
91692585|NCT02282813|183280295|SUPERIORITY_OR_OTHER|||||||0.4817|||||||Cochran-Mantel-Haenszel|||||||0.4817
91692586|NCT02282813|183280296|SUPERIORITY_OR_OTHER|||||||0.8086|||||||Cochran-Mantel-Haenszel|||||||0.8086
91692587|NCT06509438|183280303|OTHER|Compare 4 weeks after the last injection to baseline|Difference of medians|-0.45|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91692588|NCT06509438|183280303|OTHER|Compare 12 weeks after the last injection to baseline|Difference of medians|-0.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91692589|NCT03331796|183280307|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.1||0.63|TWO_SIDED|95.0|-4.8|7.9|||Regression, Linear|Adjusted for baseline||||7.9|-4.8|0.63
91692590|NCT03331796|183280307|SUPERIORITY||Mean Difference (Final Values)|6.9|STANDARD_ERROR_OF_MEAN|3.3||0.0476|TWO_SIDED|95.0|0.1|13.7|||Regression, Linear|||||13.7|0.1|0.0476
91692591|NCT03331796|183280308|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.1||0.45|TWO_SIDED|95.0|-11.4|5.2|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.2|-11.4|0.45
91692592|NCT03331796|183280308|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|4.4||0.21|TWO_SIDED|95.0|-3.3|14.8|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||14.8|-3.3|0.21
91692593|NCT03331796|183280309|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.38||0.29|TWO_SIDED|95.0|-0.36|1.19|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.19|-0.36|0.29
91692594|NCT03331796|183280309|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.4||0.51|TWO_SIDED|95.0|-0.55|1.08|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.08|-0.55|0.51
91692595|NCT03331796|183280310|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.33|TWO_SIDED|95.0|-1.0|3.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.0|-1.0|.33
91722662|NCT04603066|183338115|SUPERIORITY||Mean Difference (Net)|0.01727052||||0.056|TWO_SIDED|95.0|-0.0005895|0.03513063|||t-test, 2 sided|||||0.03513063|-0.0005895|0.056
91722663|NCT00695019|183338327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Chi-squared|||||||0.61
91722664|NCT00695019|183338328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||Chi-squared|||||||0.48
91722665|NCT00695019|183338329|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||Kruskal-Wallis|||||||0.77
91722666|NCT00695019|183338330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Kruskal-Wallis|||||||0.30
91489434|NCT04622306|182851734|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CLof difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Test condom total clinical failure rate - control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
91489435|NCT04622306|182851734|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CL for difference|2.37||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set|GEE|||The non-inferiority analysis was repeated after removing couples where the male partner had a penis length greater than 170 mm. The polyurethane condom B has a specified nominal length of 170 mm and is not recommended for men with penises longer than the length of the condom.||2.5||0.025
91489436|NCT04269707|182851736|NON_INFERIORITY|Change in hemoglobin from baseline to day 35 was assessed using paired t-tests (two-sided test, alpha = 0.05).|Mean Difference (Final Values)|0.7||||0.1711|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided|||||1.80|-0.40|0.1711
91527885|NCT04362137|182930795|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.33|TWO_SIDED|95.0|0.9|1.37|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.37|0.90|0.330
91692596|NCT03331796|183280310|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0038|TWO_SIDED|95.0|1.1|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|1.1|0.0038
91692597|NCT03331796|183280311|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.78||0.58|TWO_SIDED|95.0|-1.1|2.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.0|-1.1|0.58
91692598|NCT03331796|183280311|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.59|TWO_SIDED|95.0|-2.2|1.3|||Regression, Linear|Adjusted for baseline||||1.3|-2.2|0.59
91722667|NCT00695019|183338331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||95.0|||||Chi-squared|||||||0.72
91722668|NCT00695019|183338332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023||95.0||||Analysis not adjusted to account for baseline differences between the groups.|Kruskal-Wallis|||||||0.0023
91722669|NCT00695019|183338333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||95.0|||||Kruskal-Wallis|||Fibrotest provides an estimate of liver fibrosis based on the values of 5 serum markers. Scores range from 0 to 1 with higher scores indicating a greater level of liver fibrosis. A negative change in Fibrotest score is therefore deemed to indicate improvement (reduction in fibrosis), while a positive change indicates worsening condition.||||0.21
91722670|NCT00695019|183338334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Chi-squared|||||||0.03
91489437|NCT01145625|182851760|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.|Mean Difference (Final Values)|-0.3||||0.917|TWO_SIDED|95.0|-6.0|5.4|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 24 data.||5.4|-6.0|0.9170
91527886|NCT04362137|182930796|SUPERIORITY||Least squares (LS) mean|-0.03|STANDARD_ERROR_OF_MEAN|0.144||0.831|TWO_SIDED|95.0|-0.31|0.25|||ANCOVA|||Day 15||0.25|-0.31|0.831
91527887|NCT04362137|182930796|SUPERIORITY||LS Mean|0.08|STANDARD_ERROR_OF_MEAN|0.155||0.624|TWO_SIDED|95.0|-0.23|0.38|||ANCOVA|||Day 29||0.38|-0.23|0.624
91692599|NCT03331796|183280312|SUPERIORITY||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|5.2||0.3|TWO_SIDED|95.0|-5.2|16.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||16.1|-5.2|0.30
91692600|NCT03331796|183280312|SUPERIORITY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|4.9||0.34|TWO_SIDED|95.0|-14.9|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|-14.9|0.34
91692601|NCT03331796|183280313|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|10.6||0.996|TWO_SIDED|95.0|-22.0|22.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||22.1|-22.0|0.996
91692602|NCT03331796|183280313|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|10.8||0.87|TWO_SIDED|95.0|-20.6|24.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||24.3|-20.6|0.87
91692603|NCT03331796|183280314|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.06||0.97|TWO_SIDED|95.0|-2.14|2.22|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.22|-2.14|0.97
91692604|NCT03331796|183280314|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|1.11||0.91|TWO_SIDED|95.0|-2.15|2.41|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.41|-2.15|0.91
91692605|NCT03331796|183280315|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|1.0||0.84|TWO_SIDED|95.0|-2.3|1.9|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.9|-2.3|0.84
91692606|NCT03331796|183280315|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.0||0.8|TWO_SIDED|95.0|-1.9|2.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.4|-1.9|0.80
91692607|NCT03331796|183280316|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.0||0.48|TWO_SIDED|95.0|-5.5|2.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.6|-5.5|0.48
91692608|NCT03331796|183280316|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|2.0||0.18|TWO_SIDED|95.0|-6.8|1.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.3|-6.8|0.18
91722671|NCT00695019|183338334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Chi-squared|||||||0.005
91722672|NCT05495997|183338356|SUPERIORITY|||||||0.015|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.015
91722673|NCT05495997|183338357|SUPERIORITY|||||||0.993|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.993
91527888|NCT04362137|182930797|SUPERIORITY||Odds Ratio (OR)|0.94||||0.944|TWO_SIDED|95.0|0.2|5.57|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||5.57|0.20|0.944
91692609|NCT03331796|183280317|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.075|TWO_SIDED|95.0|-5.7|0.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.3|-5.7|0.075
91692610|NCT03331796|183280317|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.6||0.195|TWO_SIDED|95.0|-5.4|1.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.1|-5.4|0.195
91692611|NCT03331796|183280318|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.4|-1.0|0.28
91692612|NCT03331796|183280318|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.1||0.21|TWO_SIDED|95.0|-0.8|3.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.6|-0.8|0.21
91692613|NCT03331796|183280319|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.66|TWO_SIDED|95.0|-3.2|2.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.1|-3.2|0.66
91722674|NCT05495997|183338358|SUPERIORITY|||||||0.517|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.517
91722675|NCT05495997|183338359|SUPERIORITY|||||||0.817|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.817
91722676|NCT04357795|183338434|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
91722677|NCT04357795|183338435|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
91527889|NCT04362137|182930797|SUPERIORITY||Odds Ratio (OR)|1.21||||0.775|TWO_SIDED|95.0|0.35|5.11|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||5.11|0.35|0.775
91527890|NCT04362137|182930798|SUPERIORITY||Odds Ratio (OR)|0.99||||0.987|TWO_SIDED|95.0|0.45|2.21|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||2.21|0.45|0.987
91692614|NCT03331796|183280319|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-4.9|0.5|||Regression, Linear|||a priori threshold for statistical significance = .05||0.5|-4.9|0.11
91692615|NCT03331796|183280320|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.11||0.59|TWO_SIDED|95.0|-0.29|0.17|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.17|-0.29|0.59
91692616|NCT03331796|183280320|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.64|TWO_SIDED|95.0|-0.17|0.28|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.28|-0.17|0.64
91692617|NCT03331796|183280323|SUPERIORITY|||||||0.768||||||a priori threshold for statistical significance = .05|ANOVA|||||||0.768
91692618|NCT00745901|183280330|SUPERIORITY_OR_OTHER|||||||0.9698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9698
91692619|NCT00745901|183280331|SUPERIORITY_OR_OTHER|||||||0.0715||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0715
91692620|NCT00745901|183280332|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0050
91692621|NCT00745901|183280333|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
91692622|NCT00745901|183280334|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0031
91692623|NCT00745901|183280335|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0013
91692624|NCT00745901|183280336|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91692625|NCT00745901|183280337|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91692626|NCT00745901|183280338|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91692627|NCT00745901|183280339|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91692628|NCT00745901|183280340|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0033
91692629|NCT00745901|183280341|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0060
91692630|NCT00745901|183280342|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91692631|NCT00745901|183280343|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91692632|NCT00745901|183280344|SUPERIORITY_OR_OTHER|||||||0.912||95.0|||||Fisher Exact|||||||0.912
91692633|NCT00745901|183280345|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
91692634|NCT00745901|183280346|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
91692635|NCT00745901|183280347|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Fisher Exact|||||||0.816
91692636|NCT00745901|183280348|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
91692637|NCT00745901|183280349|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
91692638|NCT01753310|183280351|SUPERIORITY_OR_OTHER||Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-12.17|-4.47|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-4.47|-12.17|<0.001
91722678|NCT04357795|183338436|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
91722679|NCT04357795|183338437|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
91692639|NCT01753310|183280352|SUPERIORITY_OR_OTHER||Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.65|=|0.001|TWO_SIDED|95.0|-8.67|-2.14|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-2.14|-8.67|=0.001
91692640|NCT01753310|183280353|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.||||<0.001
91692641|NCT01753310|183280354|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||=0.033
91692642|NCT01753310|183280355|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||<0.001
91692643|NCT01753310|183280356|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||<0.001
91692644|NCT01753310|183280357|SUPERIORITY_OR_OTHER||||||=|0.174|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.174
91692645|NCT01753310|183280358|SUPERIORITY_OR_OTHER||||||=|0.583|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.583
91692646|NCT04390763|183280369|OTHER||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||1.04|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.04||
91692647|NCT04390763|183280369|OTHER||Hazard Ratio (HR)|1.41|||||ONE_SIDED|90.0||1.96|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.96||
91692648|NCT04390763|183280370|OTHER||Hazard Ratio (HR)|1.02||||0.46|ONE_SIDED|90.0||1.37|||Regression, Cox|||||1.37||0.46
91692649|NCT04390763|183280370|OTHER||Hazard Ratio (HR)|1.08||||0.38|ONE_SIDED|90.0||1.44|||Regression, Cox|||||1.44||0.38
91692650|NCT01786993|183280396|SUPERIORITY_OR_OTHER||Event-Free Probability|0.932|||||TWO_SIDED|95.0|0.904|0.951||||||"The hypothesis is formally expressed as:~H0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months \> 75%"||0.951|0.904|
91692651|NCT01786993|183280397|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.|Difference of proportions|-0.049||||0.0131|ONE_SIDED|97.5|-0.138||||normal approximation for binomial dist|||"H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15~Ha: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) \> -0.15~The null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15."|||-0.138|0.0131
91692652|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.89|||||TWO_SIDED|95.0|0.68|1.16|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.16|0.68|
91692653|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.95|||||TWO_SIDED|95.0|0.73|1.23|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.73|
91489438|NCT01145625|182851761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.4158|TWO_SIDED|95.0|-3.4|8.2|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 12 data.||8.2|-3.4|<0.4158
91722680|NCT04357795|183338438|OTHER|Single group analysis||||||0.0323|||||||Paired t-test|OD- Right eye p value||||||0.0323
91722681|NCT04357795|183338438|OTHER|Single group analysis||||||0.3447||||||OS: P-Value|Paired t-test|||||||0.3447
91722682|NCT04357795|183338439|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
91722683|NCT04357795|183338440|OTHER|Single group analysis||||||0.0029|||||||Paired t-test|||||||0.0029
91722684|NCT03785366|183338493|OTHER|"For the primary analysis, a ANOVA model with treatment as a fixed effect and subject as a random effect was used to analyze the uncorrected PK parameters Cmax, Cmean, and AUC0-56 days.~Analysis methodology for the secondary analysis mirrored the approach for the primary analysis applied to the baseline-corrected PK parameters."|test to Reference geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||||1.25|0.80|
91722685|NCT05168800|183338502|SUPERIORITY|||||||0.99||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.99
91722686|NCT05168800|183338502|SUPERIORITY|||||||0.98||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.98
91722687|NCT05168800|183338502|EQUIVALENCE|A sample size of 1800 LTCWs (600 per arm) was identified to provide 80% power to detect an 8% difference in the rate of individuals reporting vaccine confidence between arms with 95% confidence. This sample size was sufficient to retain 80% power to detect a 10% difference after 40% attrition. Per study design, the equivalence margin is +/- 10% with anticipated attrition using the binomial confidence interval.||||||0.85||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or +/- 2.45 standard deviations of the mean for the equivalency test.|Groupwise binomial comparison|||||||0.85
91722688|NCT05168800|183338503|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
91722689|NCT05168800|183338503|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.90
91722690|NCT05168800|183338503|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Fisher Exact|||||||0.83
91722691|NCT05168800|183338504|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
91722692|NCT05168800|183338504|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
91722693|NCT05168800|183338504|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.61|||||||Fisher Exact|||||||0.61
91527891|NCT04362137|182930799|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.738|TWO_SIDED|95.0|0.84|1.28|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.28|0.84|0.738
91722694|NCT05168800|183338505|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
91722695|NCT05168800|183338505|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
91722696|NCT05168800|183338505|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Fisher Exact|||||||0.48
91722697|NCT05168800|183338506|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
91722698|NCT05168800|183338506|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
91722699|NCT05168800|183338506|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Adjusted Wald test|||||||0.48
91722700|NCT05168800|183338507|SUPERIORITY|||||||0.95|||||||Adjusted Wald test|||||||0.95
91722701|NCT05168800|183338507|SUPERIORITY|||||||0.98|||||||Adjusted Wald test|||||||0.98
91722702|NCT05168800|183338507|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.66|||||||Adjusted Wald test|||||||0.66
91722703|NCT05168800|183338508|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
91722704|NCT05168800|183338508|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
91722705|NCT05168800|183338508|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.09|||||||Fisher Exact|||||||0.09
91722706|NCT05168800|183338509|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
91722707|NCT05168800|183338509|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
91722708|NCT05168800|183338509|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.1|||||||Fisher Exact|||||||0.10
91722709|NCT05168800|183338510|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
91722710|NCT05168800|183338510|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
91722711|NCT05168800|183338510|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.88|||||||Fisher Exact|||||||0.88
91722712|NCT05168800|183338511|SUPERIORITY|||||||0.92|||||||Adjusted Wald test|||||||0.92
91722713|NCT05168800|183338511|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
91722714|NCT05168800|183338511|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Adjusted Wald test|||||||0.83
91722715|NCT05168800|183338512|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
91722716|NCT05168800|183338512|SUPERIORITY|||||||0.49|||||||Adjusted Wald test|||||||0.49
91722717|NCT05168800|183338512|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.23|||||||Adjusted Wald test|||||||0.23
91722718|NCT05168800|183338513|SUPERIORITY|||||||0.9|||||||Adjusted Wald test|||||||0.90
91722719|NCT05168800|183338513|SUPERIORITY|||||||0.94|||||||Adjusted Wald test|||||||0.94
91722720|NCT05168800|183338513|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.86|||||||Adjusted Wald test|||||||0.86
91722721|NCT05168800|183338514|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
91722722|NCT05168800|183338514|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.0
91722723|NCT05168800|183338514|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.49|||||||Two-sample z test|||||||0.49
91722724|NCT05168800|183338515|SUPERIORITY|||||||0.88|||||||Two-sample z test|||||||0.88
91722725|NCT05168800|183338515|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
91722726|NCT05168800|183338515|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.02|||||||Two-sample z test|||||||0.02
91722727|NCT05168800|183338516|SUPERIORITY|||||||0.82|||||||Two-sample z test|||||||0.82
91722728|NCT05168800|183338516|SUPERIORITY|||||||0.97|||||||Two-sample z test|||||||0.97
91722729|NCT05168800|183338516|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.18|||||||Two-sample z test|||||||0.18
91722730|NCT05360056|183338579|SUPERIORITY|paired t-test|Mean Difference (Net)|8.51|STANDARD_DEVIATION|28.0||0.03|TWO_SIDED|||||unadjusted p-value|paired t-test|||Paired t-test was performed comparing the %Time in range from 2 weeks to 12 weeks||||0.03
91722731|NCT05360056|183338581|SUPERIORITY||Wilcoxon signed rank|9.85|||<|0.0001|||||||paired Wilcoxon rank test|||||||<0.0001
91722732|NCT00927472|183338663|SUPERIORITY_OR_OTHER|||||||0.0386|||||||t-test, 2 sided|||||||0.0386
91722733|NCT00927472|183338664|SUPERIORITY_OR_OTHER|||||||0.3675|||||||t-test, 2 sided|||||||0.3675
91722734|NCT00927472|183338665|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.0490
91722735|NCT00927472|183338666|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91722736|NCT00927472|183338667|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
91722737|NCT00927472|183338668|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
91722738|NCT00927472|183338669|SUPERIORITY_OR_OTHER|||||||0.3817|||||||t-test, 2 sided|||||||0.3817
91722739|NCT00927472|183338670|SUPERIORITY_OR_OTHER|||||||0.1059|||||||t-test, 2 sided|||||||0.1059
91722740|NCT00927472|183338671|SUPERIORITY_OR_OTHER|||||||0.1088|||||||t-test, 2 sided|||||||0.1088
91722741|NCT00927472|183338672|SUPERIORITY_OR_OTHER|||||||0.1527|||||||t-test, 2 sided|||||||0.1527
91722742|NCT04707469|183338673|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.27||||0.0006|TWO_SIDED|95.0|-0.42|-0.12||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.12|-0.42|0.0006
91722743|NCT04707469|183338673|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.38||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.38|-0.68|<.0001
91722744|NCT04635423|183338720|SUPERIORITY||Observed Efficacy (%)|89.3|||<|0.001|TWO_SIDED|95.0|55.4|98.2||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||98.2|55.4|<0.001
91722745|NCT04635423|183338721|OTHER||Difference in Percentages|40.1|||||TWO_SIDED|95.0|34.5|45.5|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||45.5|34.5|
91722746|NCT04635423|183338722|OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-4.4|5.2|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||5.2|-4.4|
91722747|NCT04635423|183338725|SUPERIORITY||Observed Efficacy (%)|63.5||||0.023|TWO_SIDED|95.0|2.7|86.0||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||86.0|2.7|0.023
91722748|NCT03488524|183338798|SUPERIORITY||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.87||0.0239|TWO_SIDED|95.0|0.56|7.9||Significance testing was 2-tailed and considered statistically significant if the calculated p-value was ≤0.05.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope.||Participants who did not enter the open-label extension (OLE) were included in this analysis.||7.90|0.56|0.0239
91722749|NCT03488524|183338799|SUPERIORITY||Hazard Ratio (HR)|0.644||||0.0475|TWO_SIDED|95.0|0.416|0.995|||Hazard ratio|||Cox Proportional Hazards analysis||0.995|0.416|0.0475
91722750|NCT03488524|183338800|SUPERIORITY||Hazard Ratio (HR)|0.621||||0.0308|TWO_SIDED|95.0|0.403|0.957|||Hazard Ratio|||||0.957|0.403|0.0308
91527892|NCT04362137|182930800|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.869|TWO_SIDED|95.0|0.84|1.23|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.23|0.84|0.869
91722751|NCT03488524|183338801|SUPERIORITY||Mean Difference (Final Values)|7.77|STANDARD_ERROR_OF_MEAN|3.55||0.0291|TWO_SIDED|95.0|0.8|14.75|||Mixed Models Analysis|||||14.75|0.80|0.0291
91722752|NCT03488524|183338802|SUPERIORITY||Mean Difference (Final Values)|4.76|STANDARD_ERROR_OF_MEAN|3.923||0.2261|TWO_SIDED|95.0|-2.95|12.47|||Mixed Models Analysis|||||12.47|-2.95|0.2261
91722753|NCT03488524|183338803|SUPERIORITY||Mean Difference (Final Values)|10.66|STANDARD_ERROR_OF_MEAN|5.103||0.0372|TWO_SIDED|95.0|0.63|20.69||Nominal p-value|Mixed Models Analysis|||||20.69|0.63|0.0372
91722754|NCT03488524|183338804|SUPERIORITY|||||||0.0503||||||Nominal p-value|Mixed Models Analysis|||||||0.0503
91722755|NCT00315445|183338806|SUPERIORITY_OR_OTHER|||||||0.035||||||P values are from a repeated measures model|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0350
91722756|NCT00315445|183338806|SUPERIORITY_OR_OTHER|||||||0.0624||||||Repeated measures analysis to assess the effects due to treatment, center, and treatment by center. Missing values = last observation carried forward (LOCF). Covariates: gender, age, race, weight, baseline pain, and previous opioid use.|Mixed Models Analysis|||||||0.0624
91722757|NCT00315445|183338807|SUPERIORITY_OR_OTHER||Day 84 Mean|46.4|||||TWO_SIDED|90.0|40.2|48.7|||Day 84 Mean|||||48.7|40.2|
91692654|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.81|1.38|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.38|0.81|
91527893|NCT04362137|182930803|SUPERIORITY||Odds Ratio (OR)|0.61||||0.325|TWO_SIDED|95.0|0.23|1.63|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.63|0.23|0.325
91692655|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.2|||||TWO_SIDED|95.0|0.9|1.6|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.6|0.9|
91692656|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.33|||||TWO_SIDED|95.0|1.0|1.77|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.77|1|
91692657|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.68|1.2|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.2|0.68|
91692658|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.63|0.97|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||0.97|0.63|
91692659|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.86|1.13|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.86|
91692660|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.35|||||TWO_SIDED|95.0|1.09|1.67|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.67|1.09|
91722758|NCT00315445|183338807|SUPERIORITY_OR_OTHER||Day 84 Mean|44.5|||||TWO_SIDED|90.0|43.3|52.4|||Day 84 Mean|||||52.4|43.3|
91722759|NCT00315445|183338807|SUPERIORITY_OR_OTHER||Day 84 Mean|46.5|||||TWO_SIDED|90.0|41.7|50.2|||Day 84 Mean|||||50.2|41.7|
91722760|NCT00315445|183338808|SUPERIORITY_OR_OTHER||Day 84 Mean|18.9|||||TWO_SIDED|90.0|5.2|26.2|||Day 84 Mean|||||26.2|5.2|
91722761|NCT00315445|183338808|SUPERIORITY_OR_OTHER||Day 84 Mean|24.4|||||TWO_SIDED|90.0|10.7|32.0|||Day 84 Mean|||||32.0|10.7|
91722762|NCT00315445|183338808|SUPERIORITY_OR_OTHER||Day 84 Mean|33.9|||||TWO_SIDED|90.0|16.0|35.2|||Day 84 Mean|||||35.2|16.0|
91722763|NCT00315445|183338809|SUPERIORITY_OR_OTHER|||||||0.0452||||||Multiple linear regression|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0452
91527894|NCT04362137|182930803|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.25|5.4||P-value was not estimable because \>97% patients fall into one category (responders) in both groups, and very few patients fall into the other one (non-responders), which made the logistic regression model fail to converge even with Firth's correction|Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||5.40|0.25|
91722764|NCT00315445|183338809|SUPERIORITY_OR_OTHER|||||||0.0962|||||||Mixed Models Analysis|||||||0.0962
91722765|NCT00315445|183338810|SUPERIORITY_OR_OTHER||Day 84 Mean|35.3|||||TWO_SIDED|90.0|24.3|35.6|||Day 84 Mean|||||35.6|24.3|
91722766|NCT00315445|183338810|SUPERIORITY_OR_OTHER||Day 84 Mean|39.0|||||TWO_SIDED|90.0|29.0|40.3|||Day 84 Mean|||||40.3|29.0|
91722767|NCT00315445|183338810|SUPERIORITY_OR_OTHER||Day 84 Mean|41.9|||||TWO_SIDED|90.0|32.1|42.5|||Day 84 Mean|||||42.5|32.1|
91722768|NCT00315445|183338811|SUPERIORITY_OR_OTHER||Day 84 Mean|52.4||||||90.0|50.3|56.6|||Day 84 Mean|||||56.6|50.3|
91722769|NCT00315445|183338811|SUPERIORITY_OR_OTHER||Day 84 Mean|52.5|||||TWO_SIDED|90.0|51.8|58.3|||Day 84 Mean|||||58.3|51.8|
91722770|NCT00315445|183338811|SUPERIORITY_OR_OTHER||Day 84 Mean|57.7|||||TWO_SIDED|90.0|52.3|58.6|||Day 84 Mean|||||58.6|52.3|
91722771|NCT00315445|183338814|SUPERIORITY_OR_OTHER||Day 84 Mean|55.3|||||TWO_SIDED|90.0|49.8|67.9|||Day 84 Mean|||||67.9|49.8|
91722772|NCT00315445|183338814|SUPERIORITY_OR_OTHER||Day 84 Mean|56.3|||||TWO_SIDED|90.0|45.9|65.3|||Day 84 Mean|||||65.3|45.9|
91722773|NCT00315445|183338814|SUPERIORITY_OR_OTHER||Day 84 Mean|63.0|||||TWO_SIDED|90.0|53.1|70.9|||Day 84 Mean|||||70.9|53.1|
91722774|NCT00315445|183338815|SUPERIORITY_OR_OTHER||Day 84 Mean|67.4|||||TWO_SIDED|90.0|61.3|68.6|||Day 84 Mean|||||68.6|61.3|
91722775|NCT00315445|183338815|SUPERIORITY_OR_OTHER||Day 84 Mean|68.8|||||TWO_SIDED|90.0|61.7|68.8|||Day 84 Mean|||||68.8|61.7|
91722776|NCT00315445|183338815|SUPERIORITY_OR_OTHER||Day 84 Mean|67.8|||||TWO_SIDED|90.0|62.0|68.7|||Day 84 Mean|||||68.7|62.0|
91722777|NCT00315445|183338820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.054|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.054
91722778|NCT00315445|183338820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.138|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.138
91722779|NCT00315445|183338821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0105|||||||Regression, Cox|For the secondary outcomes no alpha adjustment for multiple comparison was performed.||||||0.0105
91722780|NCT00315445|183338821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.0024|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.0024
91722781|NCT00315445|183338822|SUPERIORITY_OR_OTHER|||||||0.033|||||||Mixed Models Analysis|||||||.033
91722782|NCT00315445|183338822|SUPERIORITY_OR_OTHER|||||||0.043|||||||Mixed Models Analysis|||||||.043
91722783|NCT00315445|183338823|SUPERIORITY_OR_OTHER|||||||0.011|||||||Mixed Models Analysis|||||||.011
91722784|NCT00315445|183338823|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||.034
91722785|NCT00315445|183338824|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||.038
91722786|NCT00315445|183338824|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|||||||0.63
91722787|NCT00315445|183338825|SUPERIORITY_OR_OTHER|||||||0.064|||||||Mixed Models Analysis|||||||.064
91722788|NCT00315445|183338825|SUPERIORITY_OR_OTHER|||||||0.066|||||||Mixed Models Analysis|||||||.066
91722789|NCT00315445|183338826|SUPERIORITY_OR_OTHER|||||||0.607|||||||Mixed Models Analysis|||||||.607
91722790|NCT00315445|183338826|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||.940
91722791|NCT00315445|183338827|SUPERIORITY_OR_OTHER|||||||0.702|||||||Mixed Models Analysis|||||||.702
91722792|NCT00315445|183338827|SUPERIORITY_OR_OTHER|||||||0.634|||||||Mixed Models Analysis|||||||.634
91722793|NCT01299909|183338831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.35|TWO_SIDED|95.0|0.67|3.51|||Regression, Logistic|||||3.51|0.67|0.35
91722794|NCT01299909|183338832|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
91722795|NCT01299909|183338833|SUPERIORITY||Mean Difference (Final Values)|6.09||||0.02|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.02
91722796|NCT01299909|183338834|SUPERIORITY||Mean Difference (Final Values)|4.96||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
91489439|NCT01145625|182851762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.598|TWO_SIDED|95.0|-7.1|4.1|||ANCOVA|P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 52 data.||4.1|-7.1|0.5980
91722797|NCT01811238|183338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|2.18|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||||<0.05
91722798|NCT01811238|183338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.37|<|0.05|TWO_SIDED|95.0|0.0|1.12|||t-test, 2 sided|The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.||||1.12|0|<0.05
91722799|NCT00143507|183338850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.945|TWO_SIDED|95.0|0.91|1.1|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.10|0.91|0.945
91722800|NCT00143507|183338851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.316|TWO_SIDED|95.0|0.94|1.22|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.22|0.94|0.316
91722801|NCT00143507|183338852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.159|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.72|0.159
91722802|NCT00143507|183338853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.85|TWO_SIDED|95.0|0.86|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.86|0.850
91722803|NCT00143507|183338854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.547|TWO_SIDED|95.0|0.92|1.16|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.16|0.92|0.547
91489440|NCT04289623|182851767|SUPERIORITY||Odds Ratio (OR)|1.19||||0.007|TWO_SIDED|95.0|1.05|1.35||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.35|1.05|.007
91489441|NCT04289623|182851767|SUPERIORITY||Odds Ratio (OR)|0.82||||0.287|TWO_SIDED|95.0|0.56|1.19||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.19|0.56|.287
91692661|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.02|0.61|
91692662|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.91|||||TWO_SIDED|95.0|0.7|1.18|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.18|0.7|
91692663|NCT00450437|183280398|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.16|||||TWO_SIDED|95.0|0.89|1.5|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.5|0.89|
91692664|NCT00450437|183280399|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|8.0|||||TWO_SIDED|95.0|3.0|14.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||14|3|
91692665|NCT00450437|183280399|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|-2|
91692666|NCT00450437|183280399|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|6.0|18.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||18|6|
91692667|NCT00450437|183280399|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.0|33.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||33|20|
91692668|NCT00450437|183280400|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction \[MenACWY minus Menactra\] was less than 6%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.||2|-1|
91722804|NCT00143507|183338855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.331|TWO_SIDED|95.0|0.71|1.12|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.12|0.71|0.331
91722805|NCT00143507|183338856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.078|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.02|0.67|0.078
91722806|NCT00143507|183338857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.583|TWO_SIDED|95.0|0.83|1.4|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.40|0.83|0.583
91489442|NCT04289623|182851767|SUPERIORITY||Odds Ratio (OR)|1.05||||0.59|TWO_SIDED|95.0|0.87|1.27||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.27|0.87|.590
91722807|NCT00143507|183338858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.501|TWO_SIDED|95.0|0.81|1.11|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.11|0.81|0.501
91722808|NCT00143507|183338859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.141|TWO_SIDED|95.0|0.78|1.04|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.04|0.78|0.141
91722809|NCT00143507|183338860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.411|TWO_SIDED|95.0|0.86|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.86|0.411
91722810|NCT00143507|183338861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.484|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.15|0.94|0.484
91722811|NCT00143507|183338862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.835|TWO_SIDED|95.0|0.9|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.90|0.835
91722812|NCT00177671|183338865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.97|STANDARD_DEVIATION|2.09||0.05|TWO_SIDED|95.0|1.0|4.41|||Log Rank|||We followed the intention to treat principle. We used Kaplan-Meier curves to quantify the percentage of participants who were free of depression recurrence over time. Cox proportional hazard models quantified hazard ratios comparing the 2 treatment groups.||4.41|1.00|.05
91722813|NCT01121926|183338878|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax,ss is between 80% and 125%.|Mean ratio|56.53|||||TWO_SIDED|90.0|49.99|63.94|||||Test/reference (%)|||63.94|49.99|
91722814|NCT01121926|183338879|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCss is between 80% and 125%.|Mean ratio|85.72|||||TWO_SIDED|90.0|81.05|90.67|||||Test/reference (%)|||90.67|81.05|
91722815|NCT01496456|183338920|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.||||||0.002
91489443|NCT04289623|182851767|SUPERIORITY||Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.05|3.32||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||3.32|1.05|.035
91489444|NCT04289623|182851768|SUPERIORITY||Odds Ratio (OR)|1.16||||0.085|TWO_SIDED|95.0|0.98|1.37||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.37|0.98|.085
91722816|NCT01496456|183338921|SUPERIORITY_OR_OTHER|||||||0.045|||||||Regression, Logistic|Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.||||||0.045
91722817|NCT01496456|183338922|SUPERIORITY_OR_OTHER|||||||0.0077|||||||Discreet Time Survival Analysis|Controlled for correlation among tooth pairs (GEE model).||||||0.0077
91722818|NCT04919161|183338923|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due sample size differences and pairwise nature of the data, a Kruskal-Wallis was conducted.||Null hypothesis for this analysis is that there will be no differences between pre-scores and post-scores across the different treatment arms. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
91722819|NCT04919161|183338923|SUPERIORITY||||||=|0.0025||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0025
91489445|NCT04289623|182851768|SUPERIORITY||Odds Ratio (OR)|0.89||||0.569|TWO_SIDED|95.0|0.6|1.33||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.33|0.60|.569
91722820|NCT04919161|183338923|SUPERIORITY||||||=|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0001
91722821|NCT04919161|183338923|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
91722822|NCT04919161|183338923|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison would be that there would be no significant difference between post-scores of the two treatment groups.||||>0.9999
91722823|NCT04919161|183338924|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: ScoreChange=(PostTest) - (PreTest). These changes in score were then compared.|||||=|0.3045||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|t-test, 2 sided|||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.3045
91722824|NCT04919161|183338925|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: PercentScoreChange = (\[(PostTest)-(PreTest)\]/\[PreTest\]) x 100%|||||=|3152||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Two-Tailed Welch t test|Due to unequal standard deviation, a two-tailed Welch's t test was used.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=3152
91722825|NCT04919161|183338926|SUPERIORITY||||||=|0.9568||||||Prior to analysis, the score change between post assessment and pre-assessment was calculated. The threshold for significance was p\<0.05.|t-test, 2 sided|An unpaired T-test was used. Normality and F-test for Variances were conducted and found to be normal.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.9568
91722826|NCT04919161|183338927|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to the pairwise nature and abnormal distribution of the pre- and post-scores, a Kruskal Wallis test was completed.||Null Hypothesis, there would be no difference between the pre-score and post-score of each treatment group. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
91692669|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
91692670|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
91692671|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
91722827|NCT04919161|183338927|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
91722828|NCT04919161|183338927|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
91722829|NCT04919161|183338927|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
91722830|NCT04919161|183338927|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
91489446|NCT04289623|182851768|SUPERIORITY||Odds Ratio (OR)|0.79||||0.24|TWO_SIDED|95.0|0.54|1.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.17|0.54|.240
91489447|NCT04289623|182851768|SUPERIORITY||Odds Ratio (OR)|0.94||||0.871|TWO_SIDED|95.0|0.45|1.95||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||1.95|0.45|.871
91489448|NCT03719612|182851769|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|4.947||0.358|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.358
91489449|NCT03719612|182851769|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|5.699||0.804|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.804
91692672|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|0|
91489450|NCT03719612|182851769|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|4.412||0.371|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.371
91692673|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|-1|
91692674|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||5|-6|
91722831|NCT04919161|183338928|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to missing measurements and the pairwise nature of the pre- and post-scores, a Kruskal Wallis test was completed.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
91722832|NCT04919161|183338928|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
91489451|NCT03719612|182851770|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-1.28|STANDARD_DEVIATION|3.952||0.03|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.030
91527895|NCT03556358|182930821|EQUIVALENCE|"Two one-sided hypothesis tests were performed for pCR in order to show that TX05 is equivalent to Herceptin:~* TEST 1: H0a: θ1 / θ2 \> 1.325 vs. H1a: θ1 / θ2 \< 1.325~* TEST 2: H0b: θ1 / θ2 \< 0.755 vs. H1b: θ1 / θ2 \> 0.755~Where θ1 is the proportion of pCR for subjects randomized to TX05 group, θ2 is the proportion of pCR for subjects randomized to Herceptin. Equivalence was concluded if the 95% CI of the risk ratio is completely contained within the pre-defined interval \[0.755, 1.325\]."|Risk Ratio (RR)|1.0783|||||TWO_SIDED|95.0|0.9185|1.2659||||||||1.2659|0.9185|
91692675|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||0|-13|
91692676|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||11|-3|
91692677|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.0|17.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||17|4|
91692678|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-13|
91692679|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-6.0|8.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||8|-6|
91692680|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|7.0|||||TWO_SIDED|95.0|0.0|14.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||14|0|
91692681|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
91722833|NCT04919161|183338928|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
91722834|NCT04919161|183338928|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
91722835|NCT04919161|183338928|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
91527896|NCT05067933|182930840|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.953|||||||Wilcoxon rank sum tests|||||||0.953
91527897|NCT05067933|182930841|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.5|||||||Wilcoxon rank sum tests|||||||0.500
91527898|NCT05067933|182930842|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.912|||||||Wilcoxon rank sum tests|||||||0.912
91527899|NCT05067933|182930843|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.678|||||||Wilcoxon rank sum tests|||||||0.678
91692682|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
91692683|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
91692684|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
91692685|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||7|-2|
91692686|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
91722836|NCT04919161|183338929|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p\<0.05.|Kruskal-Wallis|Due to the missing measurement and the pairwise nature of the perturbation levels between participants, a Kruskal Wallis test was completed.||Null hypothesis is there are no differences between groups. Prior to hypothesis testing, normality testing was conducted using a Shapiro-Wild test to inform if parametric or non-parametric testing was required.||||<0.0001
91759960|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35|||||TWO_SIDED|95.0|0.92|15.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.77|0.92|
91527900|NCT05067933|182930844|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.257|||||||Wilcoxon rank sum tests|||||||0.257
91527901|NCT05067933|182930845|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.748|||||||Wilcoxon rank sum tests|||||||0.748
91692687|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
91692688|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
91722837|NCT04919161|183338929|SUPERIORITY||||||>|0.9999||||||Reported p-value is adjusted for multiple comparisons. The a priori threshold for statistical significance was established as p\<0.05.|Dunn's Multiple Comparison Test|||Null hypothesis for any comparisons would be that there is no significant mean perturbation level between sessions.|The p-value reported above was the result for 15 comparisons of the recorded perturbation levels in sessions: 1 vs 2, 2 vs 3, 3 vs 4, 3 vs 5, 3 vs 6, 4 vs 5, 4 vs 6, 4 vs 7, 4 vs 8, 5 vs 6, 5 vs 7, 5 vs 8, 6 vs 7, 6 vs 8, and 7 vs 8.|||>0.9999
91722838|NCT04919161|183338929|SUPERIORITY||||||=|0.0629|||||||Dunn's Multiple Comparison Test|||||||=0.0629
91722839|NCT04919161|183338929|SUPERIORITY||||||=|0.0069|||||||Dunn's Multiple Comparison Test|||||||=0.0069
91692689|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||4|-2|
91692690|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
91692691|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
91692692|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||5|-5|
91692693|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
91692694|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||1|-11|
91692695|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-8.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-8|
91722840|NCT04919161|183338929|SUPERIORITY||||||=|0.0003|||||||Dunn's Multiple Comparison Test|||||||=0.0003
91722841|NCT04919161|183338929|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
91722842|NCT04919161|183338929|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
91722843|NCT04919161|183338929|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
91722844|NCT04919161|183338929|SUPERIORITY||||||=|0.6497|||||||Dunn's Multiple Comparison Test|||||||=0.6497
91722845|NCT04919161|183338929|SUPERIORITY||||||=|0.0743|||||||Dunn's Multiple Comparison Test|||||||=0.0743
91722846|NCT04919161|183338929|SUPERIORITY||||||=|0.0198|||||||Dunn's Multiple Comparison Test|||||||=0.0198
91489452|NCT03719612|182851770|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|4.466||0.312|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.312
91692696|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)||5|-3|
91722847|NCT04919161|183338929|SUPERIORITY||||||=|0.0017|||||||Dunn's Multiple Comparison Test|||||||=0.0017
91722848|NCT04919161|183338929|SUPERIORITY||||||=|0.0006|||||||Dunn's Multiple Comparison Test|||||||=0.0006
91722849|NCT04919161|183338929|SUPERIORITY||||||=|0.5297|||||||Dunn's Multiple Comparison Test|||||||=0.5297
91692697|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
91692698|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
91692699|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
91692700|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
91692701|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||3|-2|
91722850|NCT04919161|183338929|SUPERIORITY||||||=|0.2595|||||||Dunn's Multiple Comparison Test|||||||=0.2595
91722851|NCT04919161|183338930|OTHER|This is a descriptive analysis.|Odds Ratio (OR)|2.6|||=|0.3898|TWO_SIDED|95.0|0.4671|15.3||Threshold for statistical significance was p\<0.05|Fisher Exact|||Null hypothesis was that there would be no difference in the proportion of males and females between treatment arms.||15.300|0.4671|=0.3898
91722852|NCT02175758|183338931|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|109.96|152.48||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||152.48|109.96|
91722853|NCT02175758|183338931|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|109.8|||||TWO_SIDED|90.0|93.25|129.29||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||129.29|93.25|
91722854|NCT02175758|183338931|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|149.67|||||TWO_SIDED|90.0|127.12|176.21||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||176.21|127.12|
91489453|NCT03719612|182851770|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.65|STANDARD_DEVIATION|4.725||0.347|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.347
91722855|NCT02175758|183338933|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 12 to \< 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to \< 18 Years Old group, then the SVR12 rate for participants aged 3 to \< 12 years would be compared with 80% at the 0.05 significance level.||||<0.001
91722856|NCT02175758|183338933|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 3 to \< 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
91722857|NCT02489773|183338950|OTHER|Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)|pearson correlation coefficient|0.6342|||||TWO_SIDED|||||||||||||
91722858|NCT02489773|183338950|OTHER|Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.|Difference with PG 0.8|-0.1658|||>|0.9999|TWO_SIDED|95.0|-0.2204|-0.1113|||t-test, 2 sided|||||-0.1113|-0.2204|>0.9999
91722859|NCT02489773|183338951|OTHER|The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficients|0.249|||<|0.0001|TWO_SIDED|95.0|0.13|0.364|||t-test, 2 sided|||||0.364|0.130|<0.0001
91722860|NCT02489773|183338952|OTHER|The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficient|0.181|||<|0.0001|TWO_SIDED|95.0|0.096|0.265|||t-test, 2 sided|||||0.265|0.096|<0.0001
91722861|NCT00712920|183338953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03||95.0|-1.7|-0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.10|-1.70|0.03
91722862|NCT00712920|183338953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.08||95.0|-1.5|0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.1|-1.5|0.08
91722863|NCT00712920|183338954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6419|STANDARD_DEVIATION|0.3924||0.102||95.0|-1.41|0.13|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.13|-1.41|0.102
91722864|NCT00712920|183338954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7925|STANDARD_DEVIATION|0.3935||0.044||95.0|-1.56|-0.02|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.02|-1.56|0.044
91722865|NCT00712920|183338955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4394|STANDARD_DEVIATION|0.3631||0.226||95.0|-1.15|0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||0.27|-1.15|0.226
91722866|NCT00712920|183338955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1252|STANDARD_DEVIATION|0.3649||0.002||95.0|-1.84|-0.41|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||-0.41|-1.84|0.002
91722867|NCT00712920|183338956|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.292
91722868|NCT00712920|183338956|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.040
91722869|NCT03755076|183338975|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91722870|NCT03755076|183338976|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91722871|NCT03483584|183339011|OTHER|Chi-square test is to detect the difference in the prevalence of hypertension between INSTI and non-INSTI groups||||||0.244||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.244
91722872|NCT03483584|183339011|OTHER|Chi square test is to detect the difference in prevalence of diabetes mellitus between INSTI and non-INSTI groups||||||0.584||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.584
91722873|NCT03483584|183339011|OTHER|Chi square test is used to detect the difference in prevalence of insulin resistance between INSTI and non-INSTI groups||||||0.067||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.067
91722874|NCT03483584|183339011|OTHER|Chi square test is used to detect the difference in prevalence of dyslipidemia between INSTI and non-INSTI groups||||||0.365||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.365
91722875|NCT03483584|183339011|OTHER|Chi square test is used to detect the difference in prevalence of metabolic syndrome between INSTI and non-INSTI groups||||||0.033||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.033
91722876|NCT03483584|183339011|OTHER|Chi square is used to detect the difference in prevalence of osteopenia between INSTI and non-INSTI groups||||||0.196||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.196
91722877|NCT03483584|183339011|OTHER|||||||1||||||The threshold for significance was set at p \< 0.05.|Fisher Exact|Fisher exact test is used when any cells have expected count less than 5.||Chi square test is used to detect the difference in prevalence of osteoporosis between INSTI and non-INSTI groups.||||1.000
91722878|NCT03483584|183339011|OTHER|||||||0.572||||||The threshold for significance was set at p \< 0.05.|Fisher Exact|Fisher exact test is used when any cells have expected less than 5.||Chi square test is used to detect the difference in prevalence of vitamin D deficiency between INSTI and non-INSTI groups.||||0.572
91722879|NCT03483584|183339011|OTHER|||||||0.698||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||Chi square test is used to detect the difference in prevalence in renal disease between INSTI and non-INSTI groups.||||0.698
91722880|NCT03483584|183339011|OTHER|Chi square test is used to detect the difference in prevalence of kidney tubular dysfunction between INSTI and non-INSTI groups.||||||0.848||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.848
91722881|NCT03483584|183339011|OTHER|Chi square test is used to detect the difference in prevalence of intermediate or advanced fibrosis (FIB-4 \>1.3) between INSTI and non-INSTI groups||||||0.274||||||The threshold for significance was set at p \< 0.05.|Chi-squared|||||||0.274
91722882|NCT03483584|183339011|OTHER|Chi square test is used to detect the difference in prevalence of advanced fibrosis (FIB-4 \>2.67) between INSTI and non-INSTI groups||||||1||||||The threshold for significance was set at p \< 0.05.|Fisher Exact|Fisher exact test is used when any cells have expected count less than 5.||||||1.000
91722883|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.508|||||TWO_SIDED|95.0|0.352|6.45|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing hypertension in INSTI group compared with non-INSTI group as reference group at 2 years.||6.450|0.352|
91722884|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.936|||||TWO_SIDED|95.0|0.251|14.919|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing hypertension in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||14.919|0.251|
91722885|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.388|||||TWO_SIDED|95.0|0.099|1.155|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing diabetes mellitus in INSTI group compared with non-INSTI group as reference group at 2 years.||1.155|0.099|
91722886|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.507|||||TWO_SIDED|95.0|0.132|1.948|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing diabetes mellitus in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||1.948|0.132|
91722887|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.743|||||TWO_SIDED|95.0|0.395|1.397|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing insulin resistance in INSTI group compared with non-INSTI group as reference group at 2 years.||1.397|0.395|
91722888|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.883|||||TWO_SIDED|95.0|0.444|1.759|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing insulin resistance in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||1.759|0.444|
91722889|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.187|||||TWO_SIDED|95.0|0.274|5.139|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing dyslipidemia in INSTI group compared with non-INSTI group as reference group at 2 years.||5.139|0.274|
91722890|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.21|||||TWO_SIDED|95.0|0.257|5.688|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing dyslipidemia in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||5.688|0.257|
91722891|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.855|||||TWO_SIDED|95.0|0.196|3.739|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing metabolic syndrome in INSTI group compared with non-INSTI group as reference group at 2 years.||3.739|0.196|
91722892|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.534|||||TWO_SIDED|95.0|0.108|2.631|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing metabolic syndrome in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||2.631|0.108|
91489454|NCT03719612|182851771|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability Echo Enhanced||0.988|0.977|
91489455|NCT03719612|182851771|OTHER||Intra-class Correlation Coefficient|0.953|||||TWO_SIDED|95.0|0.936|0.966||||||Inter-Reader Variability Echo Unenhanced||0.966|0.936|
91489456|NCT03719612|182851771|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-Reader Variability Echo Enhanced||0.978|0.958|
91489457|NCT03719612|182851771|OTHER||Intra-class Correlation Coefficient|0.944|||||TWO_SIDED|95.0|0.923|0.959||||||Inter-Reader Variability Echo Unenhanced||0.959|0.923|
91489458|NCT03719612|182851771|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.947|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.947|
91489459|NCT03719612|182851771|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability Echo Unenhanced||0.958|0.920|
91489460|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.988||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.988|0.978|
91489461|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.967|0.983||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.983|0.967|
91722893|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.396|||||TWO_SIDED|95.0|0.172|11.35|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing osteopenia in INSTI group compared with non-INSTI group as reference group at 2 years.||11.350|0.172|
91722894|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.053|||||TWO_SIDED|95.0|0.119|9.317|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing osteopenia in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||9.317|0.119|
91527902|NCT05067933|182930846|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.946|||||||Wilcoxon rank sum tests|||||||0.946
91722895|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||No incidence of osteoporosis was reported in non-INSTI group at 2 years.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing osteoporosis in INSTI group compared with non-INSTI group as reference group at 2 years.||0|0|
91722896|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||No incidence of osteoporosis was reported in non-INSTI group at 2 years.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing osteoporosis in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||0|0|
91722897|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|2.198|||||TWO_SIDED|95.0|0.679|7.122|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing vitamin D deficiency in INSTI group compared with non-INSTI group as reference group at 2 years.||7.122|0.679|
91722898|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|3.551|||||TWO_SIDED|95.0|0.85|14.833|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing vitamin D deficiency in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||14.833|0.850|
91722899|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.197|||||TWO_SIDED|95.0|0.465|3.077|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing renal diseases in INSTI group compared with non-INSTI group as reference group at 2 years.||3.077|0.465|
91722900|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.538|||||TWO_SIDED|95.0|0.51|4.638|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing renal diseases in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||4.638|0.510|
91722901|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|1.166|||||TWO_SIDED|95.0|0.408|3.331|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing kidney tubular dysfunction in INSTI group compared with non-INSTI group as reference group at 2 years.||3.331|0.408|
91527903|NCT05067933|182930849|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.356|||||||Wilcoxon rank sum tests|||||||0.356
91722902|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|2.101|||||TWO_SIDED|95.0|0.615|7.18|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing kidney tubular dysfunction in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||7.180|0.615|
91722903|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.563|||||TWO_SIDED|95.0|0.159|1.995|||||Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR \>1 meaning higher risk of developing new HANA conditions.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing intermediate or advanced fibrosis (FIB-4 \> 1.3) in INSTI group compared with non-INSTI group as reference group at 2 years.||1.995|0.159|
91722904|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.922|||||TWO_SIDED|95.0|0.244|3.493|||||Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR \>1 meaning higher risk of developing new HANA conditions.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing intermediate or advanced fibrosis (FIB-4 \> 1.3) in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||3.493|0.244|
91527904|NCT05067933|182930850|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.267|||||||Wilcoxon rank sum tests|||||||0.267
91692702|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-8|
91722905|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||No incidence in advanced fibrosis (FIB-4 \>2.67) was reported in non-INSTI group at 2 years.|Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing advanced fibrosis (FIB-4 \>2.67) in INSTI group compared with non-INSTI group as reference group at 2 years.||0|0|
91489462|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.963|0.981||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.981|0.963|
91692703|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-9.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||0|-9|
91692704|NCT00450437|183280401|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||3|-5|
91692705|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
91692706|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||9|1|
91692707|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.||20|11|
91692708|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|23.0|||||TWO_SIDED|95.0|19.0|28.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||28|19|
91692709|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
91692710|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|0.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|0|
91692711|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|4.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||9|4|
91692712|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||20|12|
91489463|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.935|||||TWO_SIDED|95.0|0.91|0.952||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.952|0.910|
91489464|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.980|0.962|
91489465|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.924|||||TWO_SIDED|95.0|0.896|0.945||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.945|0.896|
91722906|NCT03483584|183339012|OTHER|Poisson loglinear|Incidence rate ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||No incidence in advanced fibrosis (FIB-4 \>2.67) was reported in non-INSTI group at 2 years.|Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing advanced fibrosis (FIB-4 \> 2.67) in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count.||0|0|
91722907|NCT04063163|183339025|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.496|0.763|||Log Rank|||Defined as a period from randomization through death regardless of causality. Data of patients without a death record will be censored on the last known survival date. COX proportional risk model will be used to estimate HR and its 95% confidence interval (CI); the Kaplan-Meier method will be used to estimate the median, and the Kaplan-Meier curve will be plotted.||0.763|0.496|<0.001
91722908|NCT04063163|183339026|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.001|TWO_SIDED|95.0|0.381|0.576|||Log Rank|||||0.576|0.381|0.001
91722909|NCT04435626|183339039|SUPERIORITY||Rate ratio|0.84||||0.0072|TWO_SIDED|95.0|0.74|0.95||Two-sided p-value; p-value threshold =0.04967;|stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.95|0.74|0.0072
91722910|NCT04435626|183339041|SUPERIORITY||Rate ratio|0.82||||0.0062|TWO_SIDED|95.0|0.71|0.94||Two-sided p-value; p-value threshold=0.04967;|Stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.94|0.71|0.0062
91722911|NCT04435626|183339043|OTHER|mixed-effects model for repeated measures (MMRM)|Difference in LS Mean|1.56|||<|0.0001|TWO_SIDED|95.0|0.79|2.34||Two-sided p-value;|Mixed Models Analysis|The analysis was performed using mixed-effects model for repeated measures (MMRM)||Difference in LS Mean||2.34|0.79|<.0001
91722912|NCT04435626|183339044|OTHER|Logistic regression analysis|Odds Ratio (OR)|1.01||||0.9295|TWO_SIDED|95.0|0.88|1.15||Two-sided p-value|Regression, Logistic|||Odds ratio (finerenone /placebo)||1.15|0.88|0.9295
91722913|NCT04435626|183339045|OTHER|Stratified log-rank test|Cause-specific Hazard Ratio|1.33||||0.1071|TWO_SIDED|95.0|0.94|1.89||two-sided p-value|Stratified log-rank test||stratified Cox proportional hazards model|Cause-specific Hazard Ratio||1.89|0.94|0.1071
91722914|NCT04435626|183339046|OTHER|Stratified log-rank test|cause-specific hazard ratio|0.93||||0.2794|TWO_SIDED|95.0|0.83|1.06||two-sided p-value|stratified log-rank||stratified Cox proportional hazards model|Hazard Ratio||1.06|0.83|0.2794
91722915|NCT04426656|183339047|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using the outcome variable measured at Week 12.||||0.85
91722916|NCT04426656|183339048|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
91489466|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-Reader Variability End Systolic Echo Enhanced||0.992|0.984|
91722917|NCT04426656|183339049|SUPERIORITY|||||||0.318|||||||Fisher Exact|||||||0.318
91722918|NCT04426656|183339050|SUPERIORITY|||||||0.527|||||||Fisher Exact|||||||0.527
91722919|NCT04426656|183339051|SUPERIORITY|||||||0.928|||||||Fisher Exact|||||||0.928
91722920|NCT04426656|183339052|SUPERIORITY|||||||0.678|||||||Fisher Exact|||||||0.678
91722921|NCT04426656|183339053|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The comparison test was made using the outcome variable measured at Week 12.||||0.26
91722922|NCT04426656|183339054|SUPERIORITY|||||||0.08|||||||Fisher Exact|||The comparison was made using data measured at Week 12.||||0.08
91722923|NCT04426656|183339055|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.03
91722924|NCT04426656|183339056|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||This comparison was made using data at Week 12.||||0.58
91722925|NCT04426656|183339057|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.85
91722926|NCT03033355|183339097|OTHER|||||||0.0012||||||Threshold for statistical significance used P-value \<0.05|Student t-Test|||Right Cingulate Body||||0.0012
91489467|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.983|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.988|0.977|
91489468|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced||0.989|0.978|
91489469|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.928|0.962||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.962|0.928|
91489470|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.978|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-Reader Variability End Systolic Echo Enhanced||0.984|0.969|
91722927|NCT03033355|183339097|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Posterior Cingulate||||0.02
91722928|NCT03033355|183339097|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Anterior Cingulate||||0.0015
91722929|NCT03033355|183339097|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Prefrontal Cortex||||0.0015
91722930|NCT03033355|183339097|OTHER|||||||0.0138||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Insula||||0.0138
91722931|NCT03033355|183339097|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Pons Micturition Center||||0.049
91722932|NCT03033355|183339097|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Cerebellum||||0.001
91722933|NCT03033355|183339097|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Lentiform Nucleus||||0.026
91722934|NCT03033355|183339097|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Lentiform Nucleus||||0.026
91722935|NCT03033355|183339097|OTHER|||||||0.015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Amygdala/parahippocampal Gyrus||||0.015
91692713|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||7|-1|
91722936|NCT05523297|183339141|NON_INFERIORITY|The test for non-inferiority was one-sided Farrington-Manning score test with non-inferiority margin 10% at a significance level of 2.5%. If the 95% CI for treatment effect not only lay above -10% (the non-inferiority margin) but also above 0, then there was evidence of superiority.|percent difference|17.55|||<|0.0001|TWO_SIDED|95.0|8.7|26.4|||Two-sided Farrington-Manning score test.||Difference between Octaplex and FP arms for effectiveness|||26.4|8.7|<0.0001
91692714|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|4.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||4|-1|
91692715|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|3.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||8|3|
91692716|NCT00450437|183280402|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|9.0|16.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||16|9|
91692717|NCT00450437|183280403|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.|hSBA GMT ratios|1.32|||||TWO_SIDED|95.0|1.12|1.56|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5."||1.56|1.12|
91692718|NCT00450437|183280403|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.|hSBA GMT ratios|1.4|||||TWO_SIDED|95.0|1.17|1.67|||ANOVA|||"Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5."||1.67|1.17|
91722937|NCT05523297|183339142|OTHER||Odds Ratio (OR)|1.91||||0.0022|TWO_SIDED|95.0|1.26|2.88|||Regression, Logistic|||||2.88|1.26|0.0022
91722938|NCT05523297|183339143|OTHER||Least Squares Mean Difference|-170.73|||<|0.0001|TWO_SIDED|95.0|-250.24|-91.22|||ANOVA|||12 hours after chest closure||-91.22|-250.24|<0.0001
91722939|NCT05523297|183339143|OTHER||Least Squares Mean Difference|-231.92|||<|0.0001|TWO_SIDED|95.0|-338.17|-125.67|||ANOVA|||24 hours after chest closure||-125.67|-338.17|<0.0001
91722940|NCT05523297|183339144|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after IMP start||5.15|1.97|<0.0001
91722941|NCT05523297|183339144|OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.83|4.52|||Regression, Logistic|||Within 24 hours after surgery start||4.52|1.83|<0.0001
91722942|NCT05523297|183339144|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after CPB end||5.15|1.97|<0.0001
91722943|NCT05523297|183339145|OTHER||Mean ratio|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Counting regression|||||0.57|0.41|<0.0001
91722944|NCT05523297|183339146|OTHER||Mean ratio|0.71||||0.0015|TWO_SIDED|95.0|0.57|0.88|||Counting regression|||||0.88|0.57|0.0015
91722945|NCT05523297|183339147|OTHER||Mean ratio|0.61||||0.001|TWO_SIDED|95.0|0.46|0.82|||Counting regression|||During the first 24 hours after IMP start||0.82|0.46|0.0010
91722946|NCT05523297|183339147|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Counting regression|||During the first 7 days after IMP start||0.76|0.45|<0.0001
91722947|NCT05523297|183339148|OTHER||Mean ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06|||Negative binomial regression|||FP including IMP (During the first 24 hours after IMP start)||0.06|0.03|<0.0001
91722948|NCT05523297|183339148|OTHER||Mean ratio|0.85||||0.8522|TWO_SIDED|95.0|0.15|4.82|||Negative binomial regression|||FP excluding IMP (During the first 24 hours after IMP start)||4.82|0.15|0.8522
91722949|NCT05523297|183339148|OTHER||Mean ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Negative binomial regression|||RBCs (During the first 24 hours after IMP start)||0.68|0.40|<0.0001
91722950|NCT05523297|183339148|OTHER||Mean ratio|0.65||||0.0169|TWO_SIDED|95.0|0.45|0.92|||Negative binomial regression|||Platelets (During the first 24 hours after IMP start)||0.92|0.45|0.0169
91722951|NCT05523297|183339148|OTHER||Mean ratio|0.57||||0.3288|TWO_SIDED|95.0|0.18|1.76|||Negative binomial regression|||Cryoprecipitate (During the first 24 hours after IMP start)||1.76|0.18|0.3288
91489471|NCT03719612|182851772|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.958|0.920|
91489472|NCT03719612|182851773|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.986|0.956|
91489473|NCT03719612|182851773|OTHER||Intra-class Correlation Coefficient|0.936|||||TWO_SIDED|95.0|0.888|0.963||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.963|0.888|
91527905|NCT01065350|182930851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.001|TWO_SIDED|95.0|2.07|26.15||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.||26.15|2.07|<0.001
91722952|NCT05523297|183339148|OTHER||Mean ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.04|0.06|||Negative binomial regression|||FP including IMP (During the first 7 days after IMP start)||0.06|0.04|<0.0001
91722953|NCT05523297|183339148|OTHER||Mean ratio|0.63||||0.5439|TWO_SIDED|95.0|0.14|2.84|||Negative binomial regression|||FP excluding IMP (During the first 7 days after IMP start)||2.84|0.14|0.5439
91722954|NCT05523297|183339148|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.74|||Negative binomial regression|||Red blood cells (During the first 7 days after IMP start)||0.74|0.47|<0.0001
91722955|NCT05523297|183339148|OTHER||Mean ratio|0.58||||0.0042|TWO_SIDED|95.0|0.4|0.84|||Negative binomial regression|||Platelets (During the first 7 days after IMP start)||0.84|0.40|0.0042
91722956|NCT05523297|183339148|OTHER||Mean ratio|0.49||||0.2241|TWO_SIDED|95.0|0.15|1.56|||Negative binomial regression|||Cryoprecipitate (During the first 7 days after IMP start)||1.56|0.15|0.2241
91722957|NCT05523297|183339149|OTHER||Odds Ratio (OR)|0.9||||0.8364|TWO_SIDED|95.0|0.32|2.52|||Regression, Logistic|||FP excluding IMP (Within 24 hours after IMP start)||2.52|0.32|0.8364
91722958|NCT05523297|183339149|OTHER||Odds Ratio (OR)|2.11||||0.0002|TWO_SIDED|95.0|1.42|3.11|||Regression, Logistic|||RBCs (Within 24 hours after IMP start)||3.11|1.42|0.0002
91722959|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.31||||0.1742|TWO_SIDED|95.0|0.89|1.91|||Regression, Logistic|||Platelets (Within 24 hours after IMP start)||1.91|0.89|0.1742
91722960|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 24 hours after IMP start)||3.38|0.58|0.4618
91722961|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.69||||0.0129|TWO_SIDED|95.0|1.12|2.55|||Regression, Logistic|||Any individual ABP (Within 24 hours after IMP start)||2.55|1.12|0.0129
91722962|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.58||||0.3297|TWO_SIDED|95.0|0.63|3.94|||Regression, Logistic|||FP excluding IMP (Within 7 days after IMP start)||3.94|0.63|0.3297
91722963|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.82||||0.0049|TWO_SIDED|95.0|1.2|2.76|||Regression, Logistic|||RBCs (Within 7 days after IMP start)||2.76|1.20|0.0049
91722964|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.26||||0.2417|TWO_SIDED|95.0|0.86|1.84|||Regression, Logistic|||Platelets (Within 7 days after IMP start)||1.84|0.86|0.2417
91722965|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 7 days after IMP start)||3.38|0.58|0.4618
91722966|NCT05523297|183339149|OTHER||Odds Ratio (OR)|1.56||||0.0564|TWO_SIDED|95.0|0.99|2.47|||Regression, Logistic|||Any individual ABP (Within 7 days after IMP start)||2.47|0.99|0.0564
91722967|NCT05523297|183339150|OTHER||Odds Ratio (OR)|1.1||||0.6956|TWO_SIDED|95.0|0.69|1.73|||Regression, Logistic|||Fibrinogen concentrate (Within 24 hours after IMP start)||1.73|0.69|0.6956
91722968|NCT05523297|183339150|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||||50.70|1.12|0.0317
91722969|NCT05523297|183339150|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 24 hours after IMP start)||796.37|2.90|<0.0001
91722970|NCT05523297|183339150|OTHER||Odds Ratio (OR)|1.334||||0.1981|TWO_SIDED|95.0|0.86|2.07|||Regression, Logistic|||Any coagulation factor product (Within 24 hours after IMP start)||2.07|0.86|0.1981
91722971|NCT05523297|183339150|OTHER||Odds Ratio (OR)|1.187||||0.4599|TWO_SIDED|95.0|0.75|1.87|||Regression, Logistic|||Fibrinogen concentrate (Within 7 days after IMP start)||1.87|0.75|0.4599
91722972|NCT05523297|183339150|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||rFVIIa (Within 7 days after IMP start)||50.70|1.12|0.0317
91722973|NCT05523297|183339150|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 7 days after IMP start)||796.37|2.90|<0.0001
91722974|NCT05523297|183339150|OTHER||Odds Ratio (OR)|1.431||||0.1073|TWO_SIDED|95.0|0.93|2.21|||Regression, Logistic|||Any coagulation factor product (Within 7 days after IMP start)||2.21|0.93|0.1073
91722975|NCT05523297|183339153|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after CPB end||3.2013|0.6429|0.3782
91722976|NCT05523297|183339153|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after IMP start||3.2013|0.6429|0.3782
91722977|NCT05523297|183339153|OTHER||Odds Ratio (OR)|1.332||||0.4899|TWO_SIDED|95.0|0.5902|3.0062|||Regression, Logistic|||Within 24 hours after surgery start||3.0062|0.5902|0.4899
91722978|NCT05523297|183339154|OTHER||Least Squares Mean Difference|-0.15||||0.0081|TWO_SIDED|95.0|-0.26|-0.04|||ANOVA|||||-0.04|-0.26|0.0081
91722979|NCT05523297|183339155|OTHER||Least Squares Mean Difference|-9.63||||0.6735|TWO_SIDED|95.0|-60.45|41.18|||ANOVA|||||41.18|-60.45|0.6735
91722980|NCT05523297|183339156|OTHER||Least Squares Mean Difference|-17.93||||0.9033|TWO_SIDED|95.0|-450.13|414.28|||ANOVA|||||414.28|-450.13|0.9033
91722981|NCT05523297|183339157|OTHER||Least Squares Mean Difference|-0.41||||0.1808|TWO_SIDED|95.0|-1.1|0.29|||ANOVA|||||0.29|-1.10|0.1808
91722982|NCT05523297|183339158|OTHER||Least Squares Mean Difference|0.28||||0.9698|TWO_SIDED|95.0|-14.78|15.34|||ANOVA|||||15.34|-14.78|0.9698
91722983|NCT05523297|183339159|OTHER||Least Squares Mean Difference|-3.1||||0.3363|TWO_SIDED|95.0|-9.61|3.42|||ANOVA|||||3.42|-9.61|0.3363
91722984|NCT05523297|183339160|OTHER||Least Squares Mean Difference|2.42||||0.5736|TWO_SIDED|95.0|-6.33|11.16|||ANOVA|||||11.16|-6.33|0.5736
91722985|NCT05523297|183339161|OTHER||Least Squares Mean Difference|-13.19||||0.2667|TWO_SIDED|95.0|-37.05|10.67|||ANOVA|||||10.67|-37.05|0.2667
91722986|NCT05523297|183339162|OTHER||Least Squares Mean Difference|12.25||||0.0658|TWO_SIDED|95.0|-0.87|25.38|||ANOVA|||||25.38|-0.87|0.0658
91722987|NCT05523297|183339163|OTHER||Least Squares Mean Difference|-0.19||||0.0726|TWO_SIDED|95.0|-0.4|0.02|||ANOVA|||||0.02|-0.40|0.0726
91722988|NCT05523297|183339168|OTHER||Odds Ratio (OR)|1.183||||0.7497|TWO_SIDED|95.0|0.4211|3.3235|||Regression, Logistic|||||3.3235|0.4211|0.7497
91722989|NCT05965427|183339170|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
91722990|NCT05965427|183339171|SUPERIORITY|||||||0.005|||||||Chi-squared|||"Statistical analysis of Any of the specified clinical complications measure"||||0.005
91489474|NCT03719612|182851773|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.931|0.978||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.978|0.931|
91489475|NCT03719612|182851773|OTHER||Intra-class Correlation Coefficient|0.921|||||TWO_SIDED|95.0|0.864|0.955||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.955|0.864|
91489476|NCT03719612|182851773|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.907|0.97||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.970|0.907|
91722991|NCT05965427|183339172|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
91722992|NCT05965427|183339174|SUPERIORITY|||||||0.002|||||||Chi-squared|||"Statistical analysis relates to not presenting with skin lesions measure"||||0.002
91722993|NCT05965427|183339178|SUPERIORITY|||||||0.114|||||||Chi-squared|||"Statistical analysis relates to any drug treatment for mpox measure"||||0.114
91722994|NCT05965427|183339179|SUPERIORITY||||||<|0.001|||||||Chi-squared|||"Statistical analysis relates to any drug for complications measure"||||<0.001
91722995|NCT05965427|183339180|SUPERIORITY|"Statistical analysis relates to lesion onset measure"|||||<|0.001|||||||Chi-squared|||||||<0.001
91722996|NCT04556097|183339201|SUPERIORITY||Rate Ratio|0.61|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|0.31|1.2|||Difference in differences|Difference in differences model with a negative binomial distribution and log link that provides rate ratio estimate of the relative difference.|The rate ratio is estimated for intervention patients as compared to controls.|||1.20|0.31|0.05
91722997|NCT04556097|183339202|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.95||0.05|TWO_SIDED|95.0|-6.53|1.12|||Difference in differences|Difference in differences model with a Gaussian distribution and identity link that provides linear estimate of the relative point difference.||||1.12|-6.53|0.05
91722998|NCT05317546|183339253|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.33||||||alpha \< 0.05|Mixed Models Analysis|Adjusted for brain tissue composition||An a priori power analysis was conducted to ensure power to detect differences in neurometabolite levels in the dACC. Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.33
91722999|NCT05317546|183339254|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.75||||||alpha \<0.05|Mixed Models Analysis|Adjusted for brain tissue composition||Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.75
91723000|NCT05317546|183339255|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Several studies have demonstrated that CBD can modulate resting-state or task-based BOLD signal under similar study design (acute dosing, 600 mg CBD) with sample sizes smaller than our sample. Due to the modeling, only participants with usable data from both medication allocation visits were included. Contrast of interest was alcohol beverages vs. non-alcohol beverages.||||>0.05
91723001|NCT05317546|183339256|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.82
91723002|NCT05317546|183339257|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.21
91723003|NCT02290184|183339259|SUPERIORITY_OR_OTHER|A multi-level regression was employed to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected confidence interval (CI).|cross-level interaction|-2.0|||||TWO_SIDED|0.05|-3.0|-1.1|||||"Multilevel regression analysis was used. The primary test of between-group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.||-1.1|-3.0|
91723004|NCT02290184|183339260|SUPERIORITY|Multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.6|||||TWO_SIDED|0.05|-3.9|-1.4|||||"Multilevel regression was used. The primary test of between group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months||-1.4|-3.9|
91723005|NCT02290184|183339261|SUPERIORITY|A multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.7|||||TWO_SIDED|95.0|-4.5|-0.91|||||"Multilevel regression was used. The primary test of between -group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months||-.91|-4.5|
91723006|NCT01017250|183339289|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.04
91723007|NCT01017250|183339290|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
91723008|NCT01017250|183339291|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.02
91723009|NCT01017250|183339292|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.0005
91723010|NCT01017250|183339293|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.53
91723011|NCT01017250|183339294|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
91723012|NCT01017250|183339295|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.76
91723013|NCT01017250|183339296|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.34
91723014|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.101|TWO_SIDED|95.0|0.4|1.09|||Log Rank|||Statistical analysis for primary efficacy composite endpoint.||1.09|0.40|= 0.101
91723015|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|1.12|||=|0.814|TWO_SIDED|95.0|0.43|2.91|||Log Rank|||Statistical analysis for Symptomatic lower extremity proximal DVT.||2.91|0.43|= 0.814
91527906|NCT01065350|182930851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.01|TWO_SIDED|95.0|1.21|8.75||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.||8.75|1.21|<0.01
91723016|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|0.4|||=|0.26|TWO_SIDED|95.0|0.08|2.07|||Log Rank|||Statistical analysis for symptomatic lower extremity distal DVT.||2.07|0.08|= 0.260
91723017|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|0.67|||=|0.538|TWO_SIDED|95.0|0.19|2.39|||Log Rank|||Statistical analysis for symptomatic upper extremity DVT.||2.39|0.19|= 0.538
91723018|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|1.02|||=|0.977|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||Statistical analysis for symptomatic non-fatal PE.||3.52|0.29|= 0.977
91723019|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.063|TWO_SIDED|95.0|0.11|1.11|||Log Rank|||Statistical analysis for asymptomatic lower extremity proximal DVT.||1.11|0.11|= 0.063
91723020|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.301|TWO_SIDED|95.0|0.21|1.62|||Log Rank|||Statistical analysis for incidental PE.||1.62|0.21|= 0.301
91723021|NCT02555878|183339297|SUPERIORITY||Hazard Ratio (HR)|0.33|||=|0.314|TWO_SIDED|95.0|0.03|3.18|||Log Rank|||Statistical analysis for VTE-related death.||3.18|0.03|= 0.314
91723022|NCT02555878|183339298|SUPERIORITY||Hazard Ratio (HR)|1.96|||=|0.265|TWO_SIDED|95.0|0.59|6.49|||Log Rank|||||6.49|0.59|= 0.265
91723023|NCT01164475|183339326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.395|TWO_SIDED|95.0|0.44|9.17|||Regression, Logistic|||The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.||9.17|0.44|0.395
91723024|NCT03160170|183339378|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
91723025|NCT03160170|183339379|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91723026|NCT03160170|183339380|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91723027|NCT04835441|183339403|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
91527907|NCT01065350|182930851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.39|TWO_SIDED|95.0|0.52|4.55||A p value of \< 0.005 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups||4.55|0.52|0.39
91723028|NCT04835441|183339404|SUPERIORITY|||||||0.308|||||||Cochran-Mantel-Haenszel|||||||0.308
91723029|NCT04835441|183339405|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
91723030|NCT04835441|183339406|SUPERIORITY|||||||0.788|||||||Kaplan-Meier methods|||||||0.788
91723031|NCT04835441|183339407|SUPERIORITY|||||||0.792|||||||Cochran-Mantel-Haenszel|||||||0.792
91723032|NCT04835441|183339408|SUPERIORITY|||||||0.302|||||||Mixed models for repeated measures|||||||0.302
91723033|NCT04835441|183339409|SUPERIORITY|||||||0.506|||||||ANOVA|||||||0.506
91723034|NCT04835441|183339410|SUPERIORITY|||||||0.659|||||||Fisher Exact|||||||0.659
91723035|NCT02293499|183339463|SUPERIORITY||partial eta squared|0.003||||0.043|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.043
91723036|NCT02293499|183339463|SUPERIORITY||partial eta squared|0.21||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
91723037|NCT02293499|183339463|SUPERIORITY||Sobel Statistic|2.4119||||0.0079|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on quality of life||||.0079
91723038|NCT02293499|183339463|SUPERIORITY||Sobel Statistic|2.1132||||0.0172|TWO_SIDED||||||Sobel|||Mediator analysis of ACQ Total score subscale on quality of life||||.0172
91723039|NCT02293499|183339464|SUPERIORITY||partial eta squared|0.001||||0.295|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||0.295
91489477|NCT03719612|182851773|OTHER||Intra-class Correlation Coefficient|0.903|||||TWO_SIDED|95.0|0.834|0.945||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.945|0.834|
91723040|NCT02293499|183339464|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
91759961|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|-6.03|8.8||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.80|-6.03|
91759962|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-8.26|6.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.52|-8.26|
91759963|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|||||TWO_SIDED|95.0|-6.23|8.49||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.49|-6.23|
91759964|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.26|||||TWO_SIDED|95.0|1.46|17.06||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.06|1.46|
91489478|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.971|0.991||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.971|
91489479|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.956|
91489480|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
91759965|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.58|||||TWO_SIDED|95.0|-6.23|9.38||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.38|-6.23|
91759966|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.27|5.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.27|-10.27|
91759967|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-5.95|9.53||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.53|-5.95|
91759968|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.87|||||TWO_SIDED|95.0|-10.89|5.14||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.14|-10.89|
91759969|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.86|||||TWO_SIDED|95.0|-14.8|1.08||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.08|-14.80|
91759970|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-22.34|-6.38||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.38|-22.34|
91759971|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.32|||||TWO_SIDED|95.0|-20.22|-4.41||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.41|-20.22|
91759972|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.14|||||TWO_SIDED|95.0|-10.12|5.85||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.85|-10.12|
91759973|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.05|||||TWO_SIDED|95.0|-22.05|-6.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.04|-22.05|
91692719|NCT00450437|183280403|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.|hSBA GMT ratios|1.76|||||TWO_SIDED|95.0|1.51|2.05|||ANOVA|||"Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5."||2.05|1.51|
91692720|NCT00450437|183280403|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.|hSBA GMT ratios|2.49|||||TWO_SIDED|95.0|2.11|2.95|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5."||2.95|2.11|
91692721|NCT00450437|183280405|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.0|5.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||5|-7|
91692722|NCT00450437|183280405|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.0|15.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.||15|3|
91723041|NCT02293499|183339465|SUPERIORITY||partial eta squared|0.002||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.140
91723042|NCT02293499|183339465|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
91723043|NCT02293499|183339466|SUPERIORITY||partial eta squared|0.001||||0.268|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.268
91527908|NCT01065350|182930852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.01|TWO_SIDED|95.0|1.54|14.92||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.||14.92|1.54|<0.01
91692723|NCT00450437|183280405|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|2.0|17.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||17|2|
91723044|NCT02293499|183339466|SUPERIORITY||partial eta squared|0.06||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.14
91527909|NCT01065350|182930852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.05|TWO_SIDED|95.0|0.91|6.29||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.||6.29|0.91|0.05
91692724|NCT00450437|183280405|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|16.0|||||TWO_SIDED|95.0|9.0|23.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||23|9|
91692725|NCT01890122|183280406|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-0.7|-0.278||An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.278|-0.700|< 0.0001
91692726|NCT01890122|183280406|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.108|<|0.0001|TWO_SIDED|95.0|-0.889|-0.467||An ANCOVA model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.467|-0.889|< 0.0001
91692727|NCT04025879|183280420|SUPERIORITY||Cox Proportional Hazard|0.58||||0.00025|TWO_SIDED|95.0|0.43|0.78|||Log Rank||Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).|||0.78|0.43|0.00025
91692728|NCT04025879|183280422|SUPERIORITY||DIFFERENCE OF PCR|20.5|||||TWO_SIDED|95.0|14.3|26.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||26.6|14.3|
91692729|NCT04025879|183280422|SUPERIORITY||Odds Ratio (OR)|6.64|||||TWO_SIDED|95.0|3.4|12.97|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||12.97|3.40|
91692730|NCT04025879|183280423|SUPERIORITY||DIFFERENCE OF MPR|23.2|||||TWO_SIDED|95.0|15.8|30.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||30.6|15.8|
91692731|NCT04025879|183280423|SUPERIORITY||Odds Ratio (OR)|4.01||||||95.0|2.48|6.49|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||6.49|2.48|
91692732|NCT00071110|183280444|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistic (t): -1.00|t-test, 2 sided|||||||0.32
91692733|NCT00071110|183280445|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Statistic (t): 1.56|t-test, 2 sided|||||||0.09
91692734|NCT00071110|183280446|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||Statistic (t): 1.40|t-test, 2 sided|||||||0.17
91723045|NCT02293499|183339467|SUPERIORITY||partial eta squared|0.001||||0.238|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.238
91723046|NCT02293499|183339467|SUPERIORITY||partial eta squared|0.03||||0.43|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.43
91723047|NCT02293499|183339467|SUPERIORITY||Slope|-0.203||||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||.024
91723048|NCT02293499|183339468|SUPERIORITY||partial eta squared|0.0||||0.484|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.484
91723049|NCT02293499|183339468|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
91489481|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.94|||||TWO_SIDED|95.0|0.896|0.966||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.966|0.896|
91692735|NCT02259010|183280456|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.82|1.19|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.19|0.82|
91692736|NCT02259010|183280457|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.35|||||TWO_SIDED|90.0|1.02|1.79|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.79|1.02|
91692737|NCT02259010|183280458|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.39|||||TWO_SIDED|90.0|0.99|1.95|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.95|0.99|
91692738|NCT02640664|183280502|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|2.93|||TWO_SIDED|95.0|-1.1|10.5||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||10.5|-1.1|
91692739|NCT02640664|183280502|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-3.4|8.3||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||8.3|-3.4|
91692740|NCT02640664|183280502|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-3.3|7.8||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||7.8|-3.3|
91692741|NCT02640664|183280505|SUPERIORITY||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|4.42|||TWO_SIDED|95.0|-0.8|16.7||P value not applicable because it's a descriptive analysis.|ANOVA|||||16.7|-0.8|
91692742|NCT02640664|183280505|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-7.3|10.5||P value not applicable because it's a descriptive analysis.|ANOVA|||||10.5|-7.3|
91692743|NCT02640664|183280505|SUPERIORITY||Mean Difference (Net)|6.4|STANDARD_ERROR_OF_MEAN|4.24|||TWO_SIDED|95.0|-2.0|14.8|||ANOVA|||||14.8|-2.0|
91692744|NCT03175536|183280527|SUPERIORITY||Mean Difference (Net)|3.4||||0.05|TWO_SIDED|95.0|-5.2|12.1|||GEE models|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||12.1|-5.2|0.05
91489482|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
91489483|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.923|||||TWO_SIDED|95.0|0.866|0.956||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.956|0.866|
91692745|NCT03175536|183280528|SUPERIORITY||Mean Difference (Net)|1.3||||0.05|TWO_SIDED|95.0|-4.4|7.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||7.0|-4.4|0.05
91692746|NCT03175536|183280529|SUPERIORITY||Mean Difference (Net)|6.0||||0.05|TWO_SIDED|95.0|0.7|11.3|||GEE model|Binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||11.3|0.7|0.05
91692747|NCT03175536|183280530|SUPERIORITY||Mean Difference (Net)|0.16||||0.05|TWO_SIDED|95.0|-0.74|1.06|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||1.06|-0.74|0.05
91692748|NCT03175536|183280531|SUPERIORITY||Median Difference (Net)|-34.0||||0.05|TWO_SIDED|95.0|-47.0|-21.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||-21|-47|0.05
91723050|NCT02293499|183339469|SUPERIORITY||partial eta squared|0.0||||0.648|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.648
91723051|NCT02293499|183339469|SUPERIORITY||partial eta squared|0.07||||0.04|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.04
91723052|NCT02293499|183339470|SUPERIORITY||partial eta squared|0.003||||0.02|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.020
91723053|NCT02293499|183339470|SUPERIORITY||partial eta squared|0.04||||0.23|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.23
91723054|NCT02293499|183339471|SUPERIORITY||partial eta squared|0.002||||0.049|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.049
91723055|NCT02293499|183339471|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
91723056|NCT02293499|183339471|SUPERIORITY||Slope|-0.294||||0.004|TWO_SIDED||||||Mixed Models Analysis|||||||.004
91723057|NCT02293499|183339471|SUPERIORITY||Sobel Statistic|-2.3505||||0.0093|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on ACQ total||||.0093
91723058|NCT03915067|183339472|SUPERIORITY||Rate Difference|65.8|||<|0.0001|TWO_SIDED|95.0|51.5|80.1||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||80.1|51.5|<0.0001
91723059|NCT03915067|183339472|SUPERIORITY||Rate Difference|76.2|||<|0.0001|TWO_SIDED|95.0|63.6|88.9||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||88.9|63.6|<0.0001
91692749|NCT00722137|183280532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.79|||Log Rank|Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.79|0.50|<0.001
91489484|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.982|0.994||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.994|0.982|
91489485|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.957|0.986||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.957|
91489486|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.973|0.991||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.973|
91723060|NCT03915067|183339495|SUPERIORITY||Rate Difference|57.9|||<|0.0001|TWO_SIDED|95.0|42.3|73.5||P-value was derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||73.5|42.3|<0.0001
91723061|NCT03915067|183339495|SUPERIORITY||Rate Difference|70.2|||<|0.0001|TWO_SIDED|95.0|56.4|84.1||P-value derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||84.1|56.4|<0.0001
91723062|NCT01001104|183339520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at 12 weeks.|Mixed Models Analysis|||||||<.001
91723063|NCT01001104|183339520|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91723064|NCT01001104|183339520|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.97|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91723065|NCT01001104|183339520|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.17|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91723066|NCT01001104|183339521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
91723067|NCT01001104|183339521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91723068|NCT01001104|183339521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91723069|NCT01001104|183339521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91723070|NCT01001104|183339522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
91723071|NCT01001104|183339522|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||Fisher Exact|||||||0.358
91723072|NCT01001104|183339522|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||||||0.014
91723073|NCT01001104|183339522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91723074|NCT01001104|183339523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
91723075|NCT01001104|183339523|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.2||||0.003||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.003
91527910|NCT01065350|182930852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.11|TWO_SIDED|95.0|0.68|13.19||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.||13.19|0.68|0.11
91723076|NCT01001104|183339523|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.54||||0.003||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.003
91723077|NCT01001104|183339523|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.48|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
91723078|NCT01001104|183339524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
91723079|NCT01001104|183339524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.2|||<|0.001||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
91723080|NCT01001104|183339524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-45.63|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
91723081|NCT01001104|183339524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.49|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
91723082|NCT01001104|183339525|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||0.987
91723083|NCT01001104|183339525|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26||||0.005||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.005
91723084|NCT01001104|183339525|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.45||||0.311||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.311
91723085|NCT01001104|183339525|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26||||0.556||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.556
91723086|NCT01001104|183339526|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||This is the p-value from the linear trend test at week 12.|Mixed Models Analysis|||||||0.202
91723087|NCT01001104|183339526|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.91||||0.917||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.917
91723088|NCT01001104|183339526|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.81||||0.264||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.264
91723089|NCT01001104|183339526|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.4||||0.346||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.346
91723090|NCT01001104|183339527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
91723091|NCT01001104|183339527|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.1||||0.036||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.036
91723092|NCT01001104|183339527|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|19.73||||0.002||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.002
91723093|NCT01001104|183339527|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|31.68|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
91723094|NCT01001104|183339529|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||This is the p-value from the Cochran-Armitage trend test (dose-effect).|Cochran-Armitage|||||||0.073
91723095|NCT01001104|183339529|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91723096|NCT01001104|183339529|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||Fisher Exact|||||||0.233
91723097|NCT02034591|183339530|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.682|||||TWO_SIDED|90.0|0.621|0.748||||||||0.748|0.621|
91723098|NCT02034591|183339531|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.813|||||TWO_SIDED|90.0|0.766|0.863||||||||0.863|0.766|
91723099|NCT02034591|183339532|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.81|||||TWO_SIDED|90.0|0.764|0.86||||||||0.860|0.764|
91723100|NCT02034591|183339533|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.884|||||TWO_SIDED|90.0|0.83|0.942||||||||0.942|0.830|
91692750|NCT00722137|183280533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.74|0.45|<0.001
91489487|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.929|||||TWO_SIDED|95.0|0.876|0.959||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.959|0.876|
91489488|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.981|||||TWO_SIDED|95.0|0.966|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.989|0.966|
91489489|NCT03719612|182851774|OTHER||Intra-class Correlation Coefficient|0.916|||||TWO_SIDED|95.0|0.855|0.952||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.952|0.855|
91692751|NCT00722137|183280535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.65|0.38|<0.001
91692752|NCT00722137|183280536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|||||0.65|0.38|=0.001
91692753|NCT00722137|183280537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.428||||0.275|TWO_SIDED|95.0|0.749|2.722|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.722|0.749|0.275
91692754|NCT00722137|183280538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.688|||<|0.007|TWO_SIDED|95.0|1.148|2.481|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.481|1.148|<0.007
91692755|NCT00722137|183280539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.173|TWO_SIDED|95.0|0.59|1.1|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||1.10|0.59|0.173
91692756|NCT05514873|183280547|NON_INFERIORITY|Non-inferiority of Week 12 MG-ADL over Baseline was shown if the upper limit of the 2-sided 95% confidence interval (CI) is less than 2.|||||<|0.001|||||||Mixed Model for Repeated Measures (MMRM)|||||||<0.001
91692757|NCT02729025|183280551|SUPERIORITY||LS Mean Treatment Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24||0.18|TWO_SIDED|95.0|-7.4|1.39|||Multivariate regression model||Treatment difference used placebo as the reference|A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp\[a\] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp\[a\]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.||1.39|-7.40|0.18
91723101|NCT02034591|183339534|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.95|||||TWO_SIDED|90.0|0.905|0.997||||||||0.997|0.905|
91692758|NCT02729025|183280552|SUPERIORITY||LS Mean Treatment Difference|-13.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED|95.0|-19.29|-8.49|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-8.49|-19.29|<0.0001
91692759|NCT02729025|183280553|SUPERIORITY||LS Mean Treatment Difference|-60.66|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-65.81|-55.51|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-55.51|-65.81|<0.0001
91692760|NCT02729025|183280554|SUPERIORITY||LS Mean Treatment Difference|-51.29|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-55.85|-47.33|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-47.33|-55.85|<0.0001
91692761|NCT01267019|183280555|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).||||< .05
91692762|NCT01267019|183280556|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91692763|NCT01267019|183280557|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91692764|NCT03782792|183280663|OTHER||Risk Difference (RD)|0.487||||0.0004|TWO_SIDED|95.0|0.215|0.672||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the primary endpoint on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.672|0.215|0.0004
91692765|NCT03782792|183280664|OTHER||Risk Difference (RD)|0.317||||0.0118|TWO_SIDED|95.0|0.022|0.527||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.527|0.022|0.0118
91692766|NCT03782792|183280665|OTHER||Risk Difference (RD)|0.346||||0.0081|TWO_SIDED|95.0|0.058|0.554||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.554|0.058|0.0081
91692767|NCT03782792|183280666|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
91723102|NCT02034591|183339535|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.947|||||TWO_SIDED|90.0|0.903|0.994||||||||0.994|0.903|
91723103|NCT01525589|183339591|SUPERIORITY|||||||0.0909|||||||Log Rank|||||||0.0909
91723104|NCT01525589|183339595|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
91692768|NCT03782792|183280667|OTHER|||||||0.0044||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0044
91723105|NCT01525589|183339599|SUPERIORITY|||||||0.0561|||||||Log Rank|||||||0.0561
91723106|NCT05370326|183339707|SUPERIORITY||Mean Difference (Net)|0.89||||0.69|TWO_SIDED|95.0|-3.67|5.46|||t-test, 2 sided|||||5.46|-3.67|0.69
91692769|NCT03782792|183280668|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
91692770|NCT03782792|183280669|OTHER||Risk Difference (RD)|0.375|||||TWO_SIDED|95.0|0.058|0.581|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.581|0.058|
91692771|NCT03782792|183280670|OTHER||Risk Difference (RD)|0.403|||||TWO_SIDED|95.0|0.096|0.607|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.607|0.096|
91723107|NCT05370326|183339712|SUPERIORITY||Mean Difference (Net)|0.23||||0.67|TWO_SIDED|95.0|-0.89|1.36|||t-test, 2 sided|||||1.36|-0.89|0.67
91723108|NCT05370326|183339713|SUPERIORITY||Mean Difference (Net)|0.59||||0.5|TWO_SIDED|95.0|-1.16|2.34|||t-test, 2 sided|||||2.34|-1.16|0.50
91723109|NCT05370326|183339714|SUPERIORITY||Mean Difference (Net)|0.2||||0.74|TWO_SIDED|95.0|-1.09|1.51|||t-test, 2 sided|||||1.51|-1.09|0.74
91723110|NCT05370326|183339716|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
91692772|NCT03782792|183280671|OTHER||Risk Difference (RD)|0.432|||||TWO_SIDED|95.0|0.096|0.636|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.636|0.096|
91692773|NCT03782792|183280673|OTHER||Risk Difference (RD)|0.151|||||TWO_SIDED|95.0|-0.138|0.401|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.401|-0.138|
91723111|NCT05370326|183339717|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
91723112|NCT01991314|183339741|NON_INFERIORITY_OR_EQUIVALENCE|We calculated, on the premise that there is non-inferiority between adolescent and adult groups in the difference in increase of mean haemoglobin levels of 0.35g/dL, with estimated standard deviation 0.7g/dL following treatment, that 45 patients in each group would be required, derived using power 80% power, 1-sided significance level 0.05 and R 0.5 for the covariate; this calculation took into account planned ANCOVA methodology and 20% patients who might be lost to follow up or withdraw.|Mean Difference (Net)|0.08||||0.23|TWO_SIDED|||||To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA (one-tailed P\<0.05) was employed to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates|ANCOVA|||||||0.23
91723113|NCT01991314|183339742|SUPERIORITY_OR_OTHER||difference in proportions|3.6|||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test was used to compare proportions (expressed as percentages) of total number of participants in each group who were iron intolerant||Chi squared test or Fisher's exact test, as appropriate.||||<0.05
91723114|NCT01991314|183339743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0||||0.96|TWO_SIDED||||||t-test, 2 sided|||Unpaired Students t test||||0.96
91723115|NCT01991314|183339744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||0.49
91692774|NCT03782792|183280674|OTHER||Median Difference (Final Values)|-16.88|||||TWO_SIDED|95.0|-67.32|12.76|||||Median difference was calculated by modified Hodges-Lehmann method.|Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 and assigned with the worst possible outcomes in rank analysis. Missing data at Week 4 were imputed and handled via assessment of ranks.||12.76|-67.32|
91692775|NCT04506463|183280713|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
91692776|NCT04506463|183280713|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
91692777|NCT04506463|183280713|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
91723116|NCT01991314|183339745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.85
91723117|NCT01991314|183339746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.69
91723118|NCT01991314|183339747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.9|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||<0.0001
91723119|NCT00879359|183339748|SUPERIORITY_OR_OTHER||Hazard Ratio, log|92.0|||||TWO_SIDED|95.0|64.0|99.0||||||||99|64|
91723120|NCT00970944|183339751|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||We will have 80% power to detect a one point difference in DRS score between the groups across the four week treatment window. With this sample size, we will be able to detect any unforeseen adverse events that have a prevalence of at least 2.5% in each group with 90% probability. With 92 patients per group we will be able to estimate the rate of adverse events to within ±10%.||||0.045
91723121|NCT00970944|183339752|SUPERIORITY_OR_OTHER||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.088||0.007||95.0|-0.41|-0.07||The final analysis used a significance level of 0.045.|Mixed Models Analysis|Final analysis adjusted for early v. late enrollment relative to date of injury, baseline CRS-R rating category (MCS vs. VS), and site.||The planned sample size of 184 patients provided 80% power to detect a difference between the AH and placebo in the rate of Disability Rating Scale (DRS) score change of 0.3 points/week (1.22 DRS point mean difference by the end of the 4-week treatment interval). Two blinded interim analyses were conducted at 60 and 120 patients recruited using the O'Brien-Fleming boundary, with alpha levels of 0.0005 and 0.014. The final analysis used an alpha level of 0.045.||-0.07|-0.41|0.007
91489490|NCT01496248|182851776|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91489491|NCT01496248|182851777|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91692778|NCT04506463|183280714|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|||||||0.062
91692779|NCT04506463|183280714|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91692780|NCT04506463|183280714|SUPERIORITY|||||||0.936|||||||Mixed Models Analysis|||||||0.936
91692781|NCT04506463|183280715|SUPERIORITY|||||||0.042|||||||Mixed Models Analysis|||||||0.042
91692782|NCT04506463|183280715|SUPERIORITY|||||||0.037|||||||Mixed Models Analysis|||||||0.037
91692783|NCT04506463|183280715|SUPERIORITY|||||||0.648|||||||Mixed Models Analysis|||||||0.648
91692784|NCT01609010|183280739|SUPERIORITY_OR_OTHER|||||||0.3023|||||||Log Rank|||||||0.3023
91692785|NCT01609010|183280740|SUPERIORITY_OR_OTHER|||||||0.3362|||||||Chi-squared|||Week 10, Cycle 1||||0.3362
91692786|NCT01609010|183280740|SUPERIORITY_OR_OTHER|||||||0.1157|||||||Chi-squared|||Week 16, Cycle 2||||0.1157
91692787|NCT01609010|183280741|SUPERIORITY_OR_OTHER|||||||0.854|||||||Chi-squared|||Week 10, Cycle 1||||0.8540
91692788|NCT01609010|183280741|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Chi-squared|||Week 16, Cycle 2||||0.0051
91692789|NCT01609010|183280743|SUPERIORITY_OR_OTHER|||||||0.784|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu+PR||||0.7840
91692790|NCT01609010|183280743|SUPERIORITY_OR_OTHER|||||||0.4419|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu||||0.4419
91723122|NCT02111980|183339785|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
91692791|NCT01609010|183280743|SUPERIORITY_OR_OTHER|||||||0.5942|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR only||||0.5942
91489492|NCT01496248|182851778|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91489493|NCT01496248|182851779|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91489494|NCT01496248|182851780|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91692792|NCT01609010|183280745|SUPERIORITY_OR_OTHER|||||||0.8946|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.8946
91692793|NCT01609010|183280747|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.4963
91692794|NCT01134107|183280752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.36|||||TWO_SIDED|95.0|0.06|0.66|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c|This was the primary gated analysis.||0.66|0.06|
91692795|NCT01134107|183280753|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.18|||||TWO_SIDED|95.0|-0.1|0.47|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c|||0.47|-0.10|
91692796|NCT01134107|183280753|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.42|||||TWO_SIDED|95.0|0.25|0.58|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c|||0.58|0.25|
91692797|NCT01134107|183280754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38|||||TWO_SIDED|95.0|-0.13|0.88|||||Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.88|-0.13|
91692798|NCT01134107|183280754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|||||TWO_SIDED|95.0|-0.26|0.31|||||Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.31|-0.26|
91489495|NCT01496248|182851781|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91489496|NCT01496248|182851782|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91489497|NCT01496248|182851783|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91527911|NCT01065350|182930853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.12|||<|0.001|TWO_SIDED|95.0|1.98|31.64||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||31.64|1.98|<0.001
91692799|NCT01134107|183280754|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.15|0.6|||||Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.60|-0.15|
91692800|NCT01134107|183280755|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|0.08|0.24|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c|||0.24|0.08|
91692801|NCT01134107|183280756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.39|1.63|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.63|0.39|
91692802|NCT01134107|183280756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36|||||TWO_SIDED|95.0|0.2|0.63|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||0.63|0.20|
91692803|NCT01134107|183280757|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose.|Crossover Model|||||||0.595
91692804|NCT01134107|183280757|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose.|Crossover Model|||||||0.506
91692805|NCT01134107|183280757|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose.|Crossover Model|||||||0.790
91692806|NCT01134107|183280759|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||negative binomial test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||0.059
91692807|NCT01134107|183280760|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||1.00
91723123|NCT03086343|183339799|NON_INFERIORITY|The non-inferiority of upadacitinib 15 mg versus abatacept was tested using the 95% confidence interval (CI) of treatment difference against a non-inferiority margin of 0.6.|LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates.|ANCOVA||Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
91723124|NCT03086343|183339800|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|ANCOVA|The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
91723125|NCT03086343|183339801|SUPERIORITY||Mean Difference|16.8|||<|0.001|TWO_SIDED|95.0|10.4|23.2||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|The stratification factor of prior failed bDMARD was used.|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||23.2|10.4|< 0.001
91723126|NCT04900272|183339802|OTHER|||||||0.785|||||||ANOVA|||||||0.785
91723127|NCT04900272|183339803|OTHER|||||||0.583|||||||ANOVA|||||||0.583
91723128|NCT04900272|183339804|OTHER|||||||0.5015|||||||ANOVA|||||||0.5015
91723129|NCT04900272|183339805|OTHER|||||||0.3536|||||||ANOVA|||||||0.3536
91723130|NCT04900272|183339806|OTHER|||||||0.2688|||||||ANOVA|||||||0.2688
91723131|NCT04900272|183339807|OTHER|||||||0.728|||||||ANOVA|||||||0.728
91723132|NCT04900272|183339808|OTHER|||||||0.473|||||||ANOVA|||||||0.473
91489498|NCT00696800|182851785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Treatment groups were formally compared with a generalized linear model for the ongoing pregnancy rate which included factors for treatment group, age at randomization, and region. A pre-defined non-inferiority margin of 8% was applied.|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-3.8|5.9||||||||5.9|-3.8|
91489499|NCT00696800|182851786|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in number of oocytes. If the 95% confidence interval of the difference exceeded -3 or +5 oocytes, then Corifollitropin Alfa treatment was not considered equivalent to the reference treatment (recFSH).|Mean Difference (Final Values)|1.2||||0.001|TWO_SIDED|95.0|0.5|1.9||Treatment groups were formally compared including covariates treatment group, age and center.|ANOVA|||||1.9|0.5|0.001
91723133|NCT04900272|183339809|OTHER|||||||0.4161|||||||ANOVA|||||||0.4161
91723134|NCT04900272|183339810|OTHER|||||||0.3356|||||||ANOVA|||||||0.3356
91723135|NCT04900272|183339811|OTHER|||||||0.9825|||||||ANOVA|||||||0.9825
91723136|NCT01625182|183339815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9838|TWO_SIDED|95.0|0.6|1.7|||Regression, Cox|||||1.7|0.6|0.9838
91723137|NCT01970371|183339825|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|26.5|||||TWO_SIDED|90.0|-0.7|51.2|||1-sided Fisher's exact test|||||51.2|-0.7|
91723138|NCT01970371|183339826|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|28.2|||||TWO_SIDED|90.0|0.7|52.5|||1-sided Fisher's exact test|||||52.5|0.7|
91723139|NCT01970371|183339827|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference in clinical cure percentage at the TOC visit between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|-0.3|||||TWO_SIDED|90.0|-26.9|26.8|||1-sided Fisher's exact test|||||26.8|-26.9|
91723140|NCT01970371|183339828|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the unadjusted hazard ratio between groups in Cohort 1 (colistin:plazomicin) is based on a Cox proportional hazards regression model.|Hazard Ratio (HR)|3.97|||||TWO_SIDED|90.0|1.08|14.61|||1-sided logrank test|||||14.61|1.08|
91723141|NCT01970371|183339829|SUPERIORITY|The two-sided 90% confidence interval for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|14.1|||||TWO_SIDED|90.0|-13.0|40.3|||1-sided Fisher's exact test|||||40.3|-13|
91723142|NCT01922011|183339862|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% CI is greater than -15%|Common Difference|-6.1||||0.421|TWO_SIDED|95.0|-19.4|7.4|||Wald||Daptomycin - Comparator|95% confidence interval of the common difference was based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.||7.4|-19.4|0.421
91489500|NCT00762385|182851808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03164|STANDARD_ERROR_OF_MEAN|0.1247||||98.3|-0.2346|0.03164|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.03164|-0.2346|
91723143|NCT01922011|183339863|SUPERIORITY_OR_OTHER||Common difference|-7.1||||0.467|TWO_SIDED|95.0|-21.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|||7.9|-21.6|0.467
91723144|NCT01922011|183339864|SUPERIORITY_OR_OTHER||Common difference|-6.2||||0.313|TWO_SIDED|95.0|-17.5|5.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOIV visit||5.0|-17.5|0.313
91723145|NCT01922011|183339864|SUPERIORITY_OR_OTHER||Common difference|-7.9||||0.239|TWO_SIDED|95.0|-19.8|4.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOT visit||4.0|-19.8|0.239
91723146|NCT01922011|183339864|SUPERIORITY_OR_OTHER||Common difference|-6.7||||0.37|TWO_SIDED|95.0|-19.1|5.8|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At TOC visit||5.8|-19.1|0.370
91723147|NCT01922011|183339865|SUPERIORITY_OR_OTHER||Common difference|-10.5||||0.23|TWO_SIDED|95.0|-26.3|5.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||5.4|-26.3|0.230
91723148|NCT01922011|183339865|SUPERIORITY_OR_OTHER||Common difference|-12.3||||0.164|TWO_SIDED|95.0|-28.5|4.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||4.4|-28.5|0.164
91723149|NCT01922011|183339865|SUPERIORITY_OR_OTHER||Common difference|-15.5||||0.043|TWO_SIDED|95.0|-31.2|1.1|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||1.1|-31.2|0.043
91723150|NCT01922011|183339865|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wald|||MRSA||||0.450
91723151|NCT01922011|183339865|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wald|||Other Pathogen||||0.280
91723152|NCT01922011|183339866|SUPERIORITY_OR_OTHER||Common difference|-6.3||||0.272|TWO_SIDED|95.0|-18.2|5.5|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|EOT||5.5|-18.2|0.272
91723153|NCT01922011|183339866|SUPERIORITY_OR_OTHER||Common difference|-4.8||||0.48|TWO_SIDED|95.0|-17.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|TOC||7.9|-17.6|0.480
91723154|NCT01922011|183339867|SUPERIORITY_OR_OTHER||Common difference|-10.1|||||TWO_SIDED|95.0|-24.8|4.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||4.2|-24.8|
91723155|NCT01922011|183339867|SUPERIORITY_OR_OTHER||Common difference|-12.2|||||TWO_SIDED|95.0|-27.2|2.8|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||2.8|-27.2|
91723156|NCT01922011|183339867|SUPERIORITY_OR_OTHER||Common difference|-10.4|||||TWO_SIDED|95.0|-25.4|5.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||5.2|-25.4|
91723157|NCT00924482|183339891|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient (R^2)|0.63||||||95.0|||||Regression, Linear|Linear regression between the average of six thermodilution cardiac output measurements was compared to the average of six ECOM output measurements||||||
91723158|NCT00975923|183339924|SUPERIORITY_OR_OTHER||infection rates per device days|2.0|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|95.0|1.0|3.0||p-value and confidence intervals|Regression, Linear|||Infection rates were analyzed using hierarchical negative binomial regression models to model infection rate changes over time and account for clustering of ICUs within hospitals and adjusting for baseline covariates. Power was calculated a priori with a 1-tailed alpha of 0.05 and group size of 30; a 50% decrease in infection rates in the Collaborative group and 15% for the Tool Kit group, yielding power ranging from 82% to 91% for testing group differences.||3.0|1.0|<.05
91723159|NCT00975923|183339925|SUPERIORITY_OR_OTHER||percentages|10.0|||<|5|TWO_SIDED|95.0|||||Chi-squared||Power calculation used alpha = .05 and group size = 30.The estimated effect was a 50% decrease in infection rates for the Collaborative Group and from 10% to 15% decrease in the Tool Kit group.Power ranged from 82%-91% for testing group differences.|It was hypothesized that the Collaborative group would engage in more processes and tools than the Tool Kit group. Power was based on infection rates.||||<05
91723160|NCT01964404|183339926|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.87|TWO_SIDED|||||p-FDR|t-test, 2 sided|||||||0.87
91723161|NCT01964404|183339928|SUPERIORITY||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.81||0.31|TWO_SIDED|95.0|-0.77|2.4|||ANOVA|||This analysis tested whether the marijuana cigarette group had different PANSS Positive symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)||2.4|-0.77|0.31
91723162|NCT01964404|183339928|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.62|TWO_SIDED|95.0|-2.4|0.18|||ANOVA|||This analysis tested whether the dronabinol group had different PANSS Positive symptom scores compared to the placebo group adjusting for the SCZ only group. (The marijuana cigarette group was tested separately per our analytic plan.)||0.18|-2.4|.62
91723163|NCT01964404|183339929|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.28|TWO_SIDED|95.0|-1.0|3.45|||ANOVA|||This analysis tested whether the marijuana cigarette group had different PANSS Negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)||3.45|-1|0.28
91723164|NCT01964404|183339929|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|1.0||0.39|TWO_SIDED|95.0|-1.1|2.85|||ANOVA|||This analysis tested whether the dronabinol group had different PANSS Positive negative scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)||2.85|-1.1|0.39
91723165|NCT01964404|183339930|SUPERIORITY||Mean Difference (Final Values)|-9.98|STANDARD_ERROR_OF_MEAN|3.424||0.004|TWO_SIDED|95.0|-16.06|-3.18||We set threshold of p\<.01 for statistical significance due to multiple comparisons|Regression, Linear|Adjusted for pre-drug exposure cognitive functioning||This analysis tested whether the dronabinol group had different verbal learning scores compared to the placebo group adjusting for the SCZ only group. (The marijuana cigarette group was tested separately per our analytic plan.)||-3.18|-16.06|0.004
91723166|NCT01964404|183339931|SUPERIORITY||Mean Difference (Final Values)|6.07|STANDARD_ERROR_OF_MEAN|4.94||0.22|TWO_SIDED|95.0|-3.62|15.75|||Regression, Linear|||This analysis tested whether the marijuana cigarette group had different anxiety scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)||15.75|-3.62|.22
91723167|NCT01964404|183339931|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|2.95||0.98|TWO_SIDED|95.0|-5.87|5.7|||Regression, Linear|||This analysis tested whether the dronabinol group had different anxiety scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.)||5.70|-5.87|0.98
91723168|NCT01964404|183339932|SUPERIORITY||Mean Difference (Final Values)|50.91|STANDARD_ERROR_OF_MEAN|20.4||0.13|TWO_SIDED|95.0|10.9|90.9|||ANOVA|||This analysis tested whether the dronabinol group had different drug experience ratings of liking scores compared to the placebo group. (The marijuana cigarette group was tested separately per our analytic plan.)||90.9|10.9|0.13
91723169|NCT01964404|183339932|SUPERIORITY||Mean Difference (Final Values)|51.1|STANDARD_ERROR_OF_MEAN|21.95||0.002|TWO_SIDED|95.0|8.01|94.07|||Regression, Linear|||This analysis tested whether the marijuana cigarette group had different drug liking scores compared to the placebo group. (The dronabinol group was tested separately per our analytic plan.)||94.07|8.01|.002
91723170|NCT01964404|183339933|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.178||0.002|TWO_SIDED|95.0|-1.0|-0.23|||Regression, Linear|||||-0.23|-1.0|0.002
91723171|NCT00876395|183339996|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1166|TWO_SIDED|95.0|0.73|1.08|||Log Rank|||||1.08|0.73|0.1166
91723172|NCT00876395|183339997|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0049|TWO_SIDED|95.0|0.48|0.91|||Log Rank|||||0.91|0.48|0.0049
91723173|NCT00876395|183340000|SUPERIORITY|||||||0.7276|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.7276
91723174|NCT00876395|183340001|SUPERIORITY|||||||0.4085|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.4085
91723175|NCT00876395|183340002|SUPERIORITY|||||||0.9573|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.9573
91527912|NCT01065350|182930853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.02|TWO_SIDED|95.0|1.07|7.65||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.||7.65|1.07|0.02
91723176|NCT00876395|183340003|SUPERIORITY|||||||0.6382|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.6382
91723177|NCT01787838|183340016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.0001|TWO_SIDED|95.0|1.65|1.96|||Chi-squared|||Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.||1.96|1.65|<.0001
91527913|NCT01065350|182930853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.33|TWO_SIDED|95.0|0.51|5.97||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.||5.97|0.51|0.33
91723178|NCT02260986|183340020|SUPERIORITY||difference in percentages|26.3|||<|0.0001|TWO_SIDED|95.0|16.34|36.26||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||36.26|16.34|<0.0001
91723179|NCT02260986|183340020|SUPERIORITY||difference in percentages|26.8|||<|0.0001|TWO_SIDED|95.0|20.33|33.28||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||33.28|20.33|<0.0001
91723180|NCT02260986|183340021|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|45.7|||<|0.0001|TWO_SIDED|95.0|35.72|55.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.||55.66|35.72|<0.0001
91723181|NCT02260986|183340021|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|40.8|||<|0.0001|TWO_SIDED|95.0|33.74|47.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.||47.81|33.74|<0.0001
91723182|NCT02260986|183340022|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|28.53|49.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||49.65|28.53|<0.0001
91759974|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||||TWO_SIDED|95.0|-9.83|7.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.30|-9.83|
91723183|NCT02260986|183340022|SUPERIORITY||difference in percentages|31.1|||<|0.0001|TWO_SIDED|95.0|23.84|38.39||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||38.39|23.84|<0.0001
91723184|NCT02260986|183340023|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.56|48.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||48.31|27.56|<0.0001
91723185|NCT02260986|183340023|SUPERIORITY||difference in percentages|34.7|||<|0.0001|TWO_SIDED|95.0|27.31|42.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||42.05|27.31|<0.0001
91723186|NCT02260986|183340024|SUPERIORITY||difference in percentages|23.5|||<|0.0001|TWO_SIDED|95.0|12.72|34.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.19|12.72|<0.0001
91723187|NCT02260986|183340024|SUPERIORITY||difference in percentages|27.5|||<|0.0001|TWO_SIDED|95.0|20.42|34.58||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.58|20.42|<0.0001
91489501|NCT00762385|182851809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00556|STANDARD_ERROR_OF_MEAN|0.02287||||98.3|-0.04297|0.00556|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.005560|-0.04297|
91489502|NCT00762385|182851810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2726|STANDARD_ERROR_OF_MEAN|0.1064||||98.3|0.04553|0.2726|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.2726|0.04553|
91489503|NCT04424888|182851818|SUPERIORITY|||||||0.21875|||||||Wilcoxon (Mann-Whitney)|||||||0.21875
91489504|NCT04424888|182851819|SUPERIORITY|||||||0.90625|||||||Wilcoxon (Mann-Whitney)|||||||0.90625
91527914|NCT01065350|182930854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.19|TWO_SIDED|95.0|-0.1|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.||0.5|-0.1|0.19
91723188|NCT02260986|183340025|SUPERIORITY||difference in percentages|43.6|||<|0.0001|TWO_SIDED|95.0|32.5|54.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||54.65|32.50|<0.0001
91489505|NCT04424888|182851820|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||Paired t-test for the species Akkermansia Munciphilae.||||0.020
91489506|NCT04424888|182851820|SUPERIORITY|||||||0.078|||||||t-test, 1 sided|||Paired t-test for the species Bifidobacterium infantis.||||0.078
91489507|NCT04424888|182851820|SUPERIORITY|||||||||||||||||Paired t-test for the species Clostridium beijerinckii.|No statistical test was conducted since Clostridium beijerinckii was not detected in any sample.|||
91489508|NCT04424888|182851820|SUPERIORITY|||||||0.2|||||||t-test, 1 sided|||Paired t-test for the species Clostridium butyricum.||||0.20
91489509|NCT04424888|182851820|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||Paired t-test for the species Anaerobutyricum hallii.||||0.12
91489510|NCT04424888|182851821|OTHER||||||||||||||||||All participants had the same number of sensors (3) throughout the study, so no statistical analysis is conducted.|||
91489511|NCT04424888|182851822|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||We test whether the average number of daily photos is greater in period 1 than in period 2.||||0.41
91489512|NCT04424888|182851823|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|||We test whether the average time between consecutive scans is smaller in period 1 than in period 2.||||0.13
91489513|NCT03779711|182851866|SUPERIORITY|||||||0.8095|||||||ANCOVA|adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 3-months post-surgery.||||0.8095
91527915|NCT01065350|182930854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.||0.5|-0.3|0.6
91723189|NCT02260986|183340025|SUPERIORITY||difference in percentages|42.5|||<|0.0001|TWO_SIDED|95.0|34.91|50.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||50.06|34.91|<0.0001
91723190|NCT02260986|183340026|SUPERIORITY||Least square (LS) mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.04|-17.43||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.43|-35.04|<0.0001
91723191|NCT02260986|183340026|SUPERIORITY||LS mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.83|-20.73||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-20.73|-32.83|<0.0001
91723192|NCT02260986|183340027|SUPERIORITY||difference in percentages|38.3|||<|0.0001|TWO_SIDED|95.0|26.96|49.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||49.66|26.96|<0.0001
91723193|NCT02260986|183340027|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|18.76|33.45||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||33.45|18.76|<0.0001
91723194|NCT02260986|183340028|SUPERIORITY||difference in percentages|40.1|||<|0.0001|TWO_SIDED|95.0|28.76|51.35||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||51.35|28.76|<0.0001
91723195|NCT02260986|183340028|SUPERIORITY||difference in percentages|27.3|||<|0.0001|TWO_SIDED|95.0|19.81|34.76||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||34.76|19.81|<0.0001
91723196|NCT02260986|183340029|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.34|48.4||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||48.40|27.34|<0.0001
91723197|NCT02260986|183340029|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.65|34.7||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||34.70|20.65|<0.0001
91723198|NCT02260986|183340030|SUPERIORITY||difference in percentages|20.9|||<|0.0001|TWO_SIDED|95.0|10.59|31.15||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||31.15|10.59|<0.0001
91723199|NCT02260986|183340030|SUPERIORITY||difference in percentages|10.7||||0.0021|TWO_SIDED|95.0|4.15|17.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||17.31|4.15|0.0021
91759975|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.67|-1.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.53|-18.67|
91723200|NCT02260986|183340031|SUPERIORITY||difference in percentages|9.6||||0.0062|TWO_SIDED|95.0|1.61|17.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||17.63|1.61|0.0062
91723201|NCT02260986|183340031|SUPERIORITY||difference in percentages|5.5||||0.0344|TWO_SIDED|95.0|0.56|10.51||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||10.51|0.56|0.0344
91723202|NCT02260986|183340032|SUPERIORITY||LS mean difference|-1.81|||<|0.0001|TWO_SIDED|95.0|-2.297|-1.322||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-1.322|-2.297|<0.0001
91723203|NCT02260986|183340033|SUPERIORITY||LS mean difference|-32.1|||<|0.0001|TWO_SIDED|95.0|-46.37|-17.82||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.82|-46.37|<0.0001
91723204|NCT02260986|183340034|SUPERIORITY||LS mean difference|-18.38|||<|0.0001|TWO_SIDED|95.0|-22.583|-14.187||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-14.187|-22.583|<0.0001
91723205|NCT02260986|183340035|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.46|-21.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-21.9|-33.46|<0.0001
91723206|NCT02260986|183340036|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.31|-3.02||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-3.02|-5.31|<0.0001
91489514|NCT03779711|182851867|SUPERIORITY|||||||0.3029|||||||ANCOVA|Adjusted for baseline circumferential strain||Analysis of covariance (ANCOVA), adjusted for baseline circumferential strain, is used to assess change in circumferential strain from baseline to 3-months post-surgery.||||0.3029
91489515|NCT03779711|182851868|SUPERIORITY|||||||0.0323|||||||ANCOVA|Adjusted for baseline longitudinal strain||Analysis of covariance (ANCOVA), adjusted for baseline longitudinal strain, is used to assess change in longitudinal strain from baseline to 3-months post-surgery.||||0.0323
91489516|NCT03779711|182851869|SUPERIORITY|||||||0.6765|||||||ANCOVA|Adjusted for baseline FAC.||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 12-months post-surgery.||||0.6765
91489517|NCT03779711|182851870|SUPERIORITY|||||||0.3456|||||||ANCOVA|Adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to discharge.||||0.3456
91489518|NCT03779711|182851871|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery.||||0.7760
91489519|NCT03779711|182851872|SUPERIORITY|||||||0.9563|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in weight from baseline to 3-months post-surgery.||||0.9563
91489520|NCT03779711|182851873|SUPERIORITY|||||||0.9095|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in heart rate from baseline to 3-months post-surgery.||||0.9095
91489521|NCT03779711|182851874|SUPERIORITY|||||||0.6391|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in oxygen saturation from baseline to 3-months post-surgery.||||0.6391
91489522|NCT03779711|182851881|SUPERIORITY|||||||0.8782|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery||||0.8782
91489523|NCT03881670|182851894|OTHER|Friedman test||||||0.0023|||||||Friedman Test|||Change in ratings over time||||0.0023
91489524|NCT03881670|182851894|OTHER|Friedman test||||||0.4679|||||||Friedman Test|||change in ratings over time||||0.4679
91489525|NCT00914485|182851896|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 1 sided|||Increase in mean, post-intervention versus baseline, across 18 providers and 369 patients.||||.03
91489526|NCT00973674|182851911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Barnard's unconditional Exact Test|||||||0.99
91489527|NCT00973674|182851912|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.67||||0.033|TWO_SIDED|95.0|0.74|3.77|||Log Rank|||||3.77|0.74|.033
91489528|NCT00973674|182851913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||t-test, 2 sided|||||||.35
91723207|NCT02260986|183340037|SUPERIORITY||LS mean difference|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.85|-5.93||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-5.93|-8.85|<0.0001
91723208|NCT02260986|183340038|SUPERIORITY||LS mean difference|-1.0||||0.1596|TWO_SIDED|95.0|-2.27|0.37||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||0.37|-2.27|0.1596
91489529|NCT02068027|182851923|SUPERIORITY|||||||0.4503||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.4503
91489530|NCT02068027|182851924|SUPERIORITY|||||||0.735||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.7350
91489531|NCT00494299|182851925|SUPERIORITY_OR_OTHER||Log Rank|0.2520462|||||||||||||The comparison between the 2 groups is done using the log rank test stratified by the response of TACE (Responder group A versus Responder group B), ECOG performance status (PS) (0 versus 1) and the number of prior TACE (1 versus 2).|||||
91489532|NCT00494299|182851925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8735||||||95.0|0.6972|1.0942|||||Hazard Ratio: Sorafenib/Placebo.|||1.0942|0.6972|
91489533|NCT00516074|182851957|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.||||||0.1585||95.0|||||ANCOVA|||||||0.1585
91489534|NCT00516074|182851958|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.1624||95.0|||||ANCOVA|||||||0.1624
91489535|NCT00516074|182851959|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.5077||95.0|||||ANCOVA|||||||0.5077
91527916|NCT01065350|182930855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.26|TWO_SIDED|95.0|-0.1|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.||0.3|-0.1|0.26
91527917|NCT01065350|182930855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||0.3|-0.2|0.71
91723209|NCT01201863|183340094|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.07816|STANDARD_ERROR_OF_MEAN|1.3315||0.954|TWO_SIDED||||||comparison of slopes|Slopes by group and slope difference||To investigate a difference in change in outcome over time between treatment and control, a trend analysis was used in place of a profile analysis, where both control and treatment arms are described more parsimoniously i.e. by a slope (change in outcome over time) (Fitzmaurice 2011).||||0.9540
91723210|NCT01149785|183340095|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|316.36|||||TWO_SIDED|90.0|286.17|349.73||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||349.73|286.17|
91759976|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.41|||||TWO_SIDED|95.0|-24.01|-6.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.82|-24.01|
91527918|NCT01065350|182930856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.61|TWO_SIDED|95.0|-2.9|1.7|||t-test, 2 sided|||Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.||1.7|-2.9|0.61
91527919|NCT01065350|182930856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.22|TWO_SIDED|95.0|-4.8|1.1|||t-test, 2 sided|||Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.||1.1|-4.8|0.22
91489536|NCT00516074|182851960|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.9034||95.0|||||ANCOVA|||||||0.9034
91489537|NCT00516074|182851961|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.427||95.0|||||ANCOVA|||||||0.4270
91489538|NCT00516074|182851962|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.26||95.0|||||ANCOVA|||||||0.2600
91489539|NCT04154930|182851977|SUPERIORITY||Treatment difference|69.7|||<|0.001|TWO_SIDED|95.0|52.54|86.89|||Cochran-Mantel-Haenszel|||||86.89|52.54|<0.001
91489540|NCT04154930|182851978|SUPERIORITY||Treatment difference|72.5|||<|0.001|TWO_SIDED|95.0|60.67|84.28|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 6 Months After Baseline||84.28|60.67|<0.001
91489541|NCT04154930|182851978|SUPERIORITY||Treatment difference|66.4|||<|0.001|TWO_SIDED|95.0|54.97|77.92|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 9 Months After Baseline||77.92|54.97|<0.001
91489542|NCT04154930|182851978|SUPERIORITY||Treatment difference|52.4|||<|0.001|TWO_SIDED|95.0|40.57|64.26|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 12 Months After Baseline||64.26|40.57|<0.001
91489543|NCT03113916|182852019|SUPERIORITY||Slope|2.63|||=|0.001|TWO_SIDED|95.0|1.05|4.2|||Mixed Models Analysis|||||4.20|1.05|=.001
91489544|NCT03113916|182852020|SUPERIORITY||Slope|-0.49||||0.23|TWO_SIDED|95.0|-1.29|0.31|||Mixed Models Analysis|||||0.31|-1.29|.23
91489545|NCT03113916|182852021|SUPERIORITY||Slope|0.000000676||||0.06|TWO_SIDED|95.0|-0.00000002|0.00000137|||Mixed Models Analysis|||||.00000137|-.00000002|.06
91489546|NCT03113916|182852022|SUPERIORITY||Slope|-5.64||||0.29|TWO_SIDED|95.0|-16.0|4.73|||Mixed Models Analysis||Values given need to be multiplied by 10 to the power of -10 (i.e., x 10\^-10).|||4.73|-16|.29
91759977|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.79|||||TWO_SIDED|95.0|-20.33|-3.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.26|-20.33|
91759978|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-14.57|2.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-14.57|
91759979|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.37|||||TWO_SIDED|95.0|-23.98|-6.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.76|-23.98|
91489547|NCT03113916|182852023|SUPERIORITY||Slope|0.351||||0.27|TWO_SIDED|95.0|-0.277|0.978|||Mixed Models Analysis|||||.978|-.277|.27
91489548|NCT03113916|182852024|SUPERIORITY||Slope|-0.015||||0.1|TWO_SIDED|95.0|-0.032|0.003|||Mixed Models Analysis|||||.003|-.032|.10
91489549|NCT03113916|182852025|SUPERIORITY||Slope|-11.2||||0.07|TWO_SIDED|95.0|-23.0|0.7|||Mixed Models Analysis|||||0.7|-23.0|.07
91489550|NCT03113916|182852026|SUPERIORITY||Slope|-0.63||||0.12|TWO_SIDED|95.0|-1.41|0.16|||Mixed Models Analysis|||||0.16|-1.41|.12
91692808|NCT01134107|183280760|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||0.472
91692809|NCT01134107|183280761|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.383
91692810|NCT01134107|183280761|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.499
91692811|NCT01134107|183280762|SUPERIORITY_OR_OTHER|||||||1||95.0||||The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test.|Gart's Test|Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation.||||||1.00
91692812|NCT01134107|183280763|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Negative Binomial Test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||<0.001
91692813|NCT01134107|183280764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Crossover Model|P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight||||||<0.001
91692814|NCT01134107|183280765|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure.|Crossover Model|||||||0.147
91692815|NCT01134107|183280765|SUPERIORITY_OR_OTHER|||||||0.894||95.0||||P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure.|Crossover Model|||||||0.894
91692816|NCT03581123|183280831|OTHER|Omnibus test for equality of means across the 4 treatment groups||||||0.16||||||Threshold for significance: 0.025 (0.05/2)|ANOVA|Adjusted for site, time period (pre-COVID, COVID, post-COVID), risk for chronicity (medium vs. high), and baseline pain intensity||The null hypothesis here is that the means are equal across the 4 treatment groups. A significant p value indicates rejection of the null.||||0.16
91692817|NCT03581123|183280831|OTHER|Estimation|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.0|||||SSM - MC|Adjusted for site, time period, risk of chronicity, and baseline pain intensity.||0.0|-0.5|
91692818|NCT03581123|183280831|OTHER|Estimation|Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||SMT - MC|Adjusted for site, time period, risk of chronicity, and baseline pain intensity.||0.3|-0.3|
91692819|NCT03581123|183280831|OTHER|Estimation|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.4|0.1|||||SSM/SMT - MC|Adjusted for site, time period, risk of chronicity, and baseline pain intensity.||0.1|-0.4|
91692820|NCT03581123|183280832|OTHER|Omnibus test for equality of means across the 4 treatment groups.||||||0.001||||||Threshold for significance: 0.025 (0.05/2)|ANOVA|Adjusted for site, time period (pre-COVID, COVID, post-COVID), risk for chronicity (medium vs. high), and baseline disability||The null hypothesis here is that the means are equal across the 4 treatment groups. A significant p value indicates rejection of the null.||||0.001
91692821|NCT03581123|183280832|OTHER|Estimation|Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-1.9|-0.5|||||SSM - MC|Adjusted for site, time period, risk of chronicity, and baseline RMDQ.||-0.5|-1.9|
91692822|NCT03581123|183280832|OTHER|Estimation|Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.2|0.4|||||SMT - MC|Adjusted for site, time period, risk of chronicity, and baseline RMDQ.||0.4|-1.2|
91692823|NCT03581123|183280832|OTHER|Estimation|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-1.9|-0.3|||||SSM/SMT - MC|Adjusted for site, time period, risk of chronicity, and baseline RMDQ.||-0.3|-1.9|
91692824|NCT03581123|183280833|OTHER|Omnibus test for equality of means across the 4 treatment groups.||||||0.006||||||Threshold for significance: 0.05|ANOVA|Adjusted for site, time period (pre-COVID, COVID, post-COVID), risk for chronicity (medium vs. high), and baseline LBP impact score.||The null hypothesis here is that the means are equal across the 4 treatment groups. A significant p value indicates rejection of the null.||||0.006
91692825|NCT03581123|183280833|OTHER|Estimation|Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-2.7|-0.6|||||SSM - MC|Adjusted for site, time period, risk of chronicity, and baseline LBP impact score.||-0.6|-2.7|
91692826|NCT03581123|183280833|OTHER|Estimation|Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.5|1.0|||||SMT - MC|Adjusted for site, time period, risk of chronicity, and baseline LBP impact score.||1.0|-1.5|
91692827|NCT03581123|183280833|OTHER|Estimation|Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-2.5|0.0|||||SSM/SMT - MC|Adjusted for site, time period, risk of chronicity, and baseline LBP impact score.||-0.0|-2.5|
91692828|NCT03581123|183280835|OTHER|Estimation (percent difference)|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-11.0|-1.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-1|-11|
91692829|NCT03581123|183280835|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-7.0|5.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||5|-7|
91692830|NCT03581123|183280835|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-8.0|||||TWO_SIDED|95.0|-13.0|2.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||2|-13|
91692831|NCT03581123|183280836|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-23.0|-7.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-7|-23|
91692832|NCT03581123|183280836|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-11.0|||||TWO_SIDED|95.0|-20.0|2.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||2|-20|
91692833|NCT03581123|183280836|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-18.0|||||TWO_SIDED|95.0|-27.0|-9.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||-9|-27|
91692834|NCT03581123|183280837|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-16.0|||||TWO_SIDED|95.0|-23.0|-10.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-10|-23|
91723211|NCT01149785|183340096|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|328.31|||||TWO_SIDED|90.0|296.42|363.63||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||363.63|296.42|
91723212|NCT01149785|183340099|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|144.13|||||TWO_SIDED|90.0|126.42|164.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||164.33|126.42|
91723213|NCT01149785|183340102|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|519.65|||||TWO_SIDED|90.0|460.42|586.5||||||Natural log transformed AUClast of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||586.50|460.42|
91723214|NCT01149785|183340103|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|516.98|||||TWO_SIDED|90.0|457.88|583.72||||||Natural log transformed AUC (0-∞) of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||583.72|457.88|
91723215|NCT01149785|183340105|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|161.42|||||TWO_SIDED|90.0|143.09|182.09||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||182.09|143.09|
91723216|NCT00817063|183340109|SUPERIORITY||Odds Ratio (OR)|3.78|||<|0.001|TWO_SIDED|95.0|2.55|5.62|||Chi-squared, Corrected|||||5.62|2.55|<0.001
91723217|NCT00817063|183340109|SUPERIORITY||Difference in Percentage|24.8|||<|0.001|TWO_SIDED|95.0|18.0|31.7|||Chi-squared, Corrected|||||31.7|18.0|<0.001
91723218|NCT00817063|183340110|SUPERIORITY||Mean Difference (Net)|-24.13|||<|0.001|TWO_SIDED|95.0|-30.4|-17.85|||Kruskal-Wallis|||||-17.85|-30.40|<0.001
91723219|NCT00817063|183340111|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001|TWO_SIDED|95.0|2.71|6.07|||Chi-squared, Corrected|||||6.07|2.71|<0.001
91723220|NCT00817063|183340111|SUPERIORITY||Difference in Percentage|25.5|||<|0.001|TWO_SIDED|95.0|18.7|32.3|||Chi-squared, Corrected|||||32.3|18.7|<0.001
91723221|NCT00817063|183340112|SUPERIORITY||Mean Difference (Net)|-22.36|||<|0.001|TWO_SIDED|95.0|-31.0|-13.73|||Kruskal-Wallis|||||-13.73|-31.00|<0.001
91723222|NCT00817063|183340113|SUPERIORITY|||||||0.047|||||||Log Rank|||||||0.047
91723223|NCT00817063|183340114|SUPERIORITY|||||||0.068|||||||Log Rank|||||||0.068
91723224|NCT00817063|183340115|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
91723225|NCT00817063|183340124|SUPERIORITY||Mean Difference (Net)|0.489||||0.179|TWO_SIDED|95.0|-0.226|1.204||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Lumbar Spine BMD||1.204|-0.226|0.179
91723226|NCT00817063|183340124|SUPERIORITY||Mean Difference (Net)|0.497||||0.089|TWO_SIDED|95.0|-0.077|1.071||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Femur BMD||1.071|-0.077|0.089
91723227|NCT03439514|183340132|SUPERIORITY||Median Difference (Net)|4.936||||0.818|TWO_SIDED|95.0|-24.246|34.118||Two-sided p-value|Van Elteren test||The Week 24 change from baseline in 6MWT between PF 07265803 and placebo was estimated using the stratified HL median difference, considering only participants who survived 24 weeks.|||34.118|-24.246|0.818
91723228|NCT03439514|183340138|OTHER||Hazard Ratio (HR)|0.43||||0.2257|TWO_SIDED|95.0|0.13|1.39|||Log Rank|||||1.39|0.13|0.2257
91723229|NCT03439514|183340139|OTHER||Hazard Ratio (HR)|1.19||||0.837|TWO_SIDED|95.0|0.3|4.63|||Log Rank|||||4.63|0.30|0.8370
91723230|NCT02903914|183340245|OTHER|||||||0.0731|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0731
91723231|NCT02903914|183340245|OTHER||pairwise geometric mean ratio (GMR)|0.933|||||TWO_SIDED|90.0|0.784|1.11||||||||1.110|0.784|
91723232|NCT02903914|183340245|OTHER||pairwise GMR|1.074|||||TWO_SIDED|90.0|0.908|1.271||||||||1.271|0.908|
91723233|NCT02903914|183340245|OTHER||pairwise GMR|1.23|||||TWO_SIDED|90.0|1.034|1.463||||||||1.463|1.034|
91723234|NCT02903914|183340246|OTHER|||||||0.1496|||||||Kruskal-Wallis|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1496
91723235|NCT02903914|183340247|OTHER|||||||0.2867|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2867
91723236|NCT02903914|183340247|OTHER||pairwise GMR|1.007|||||TWO_SIDED|90.0|0.825|1.23||||||||1.230|0.825|
91723237|NCT02903914|183340247|OTHER||pairwise GMR|1.081|||||TWO_SIDED|90.0|0.892|1.311||||||||1.311|0.892|
91723238|NCT02903914|183340247|OTHER||pairwise GMR|1.234|||||TWO_SIDED|90.0|1.011|1.507||||||||1.507|1.011|
91723239|NCT02903914|183340248|OTHER|||||||0.6167|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6167
91723240|NCT02903914|183340248|OTHER||pairwise GMR|1.014|||||TWO_SIDED|90.0|0.82|1.255||||||||1.255|0.820|
91723241|NCT02903914|183340248|OTHER||pairwise GMR|1.043|||||TWO_SIDED|90.0|0.849|1.281||||||||1.281|0.849|
91723242|NCT02903914|183340248|OTHER||pairwise GMR|1.17|||||TWO_SIDED|90.0|0.945|1.447||||||||1.447|0.945|
91723243|NCT02903914|183340252|OTHER|||||||0.0745|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0745
91723244|NCT02903914|183340252|OTHER||pairwise GMR|1.127|||||TWO_SIDED|90.0|0.947|1.341||||||||1.341|0.947|
91723245|NCT02903914|183340252|OTHER||pairwise GMR|0.991|||||TWO_SIDED|90.0|0.833|1.18||||||||1.180|0.833|
91723246|NCT02903914|183340252|OTHER||pairwise GMR|1.258|||||TWO_SIDED|90.0|1.064|1.486||||||||1.486|1.064|
91723247|NCT02903914|183340253|OTHER|||||||0.0518|||||||Kruskal-Wallis|||||||0.0518
91723248|NCT02903914|183340254|OTHER|||||||0.1723|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1723
91723249|NCT02903914|183340254|OTHER||pairwise GMR|1.156|||||TWO_SIDED|90.0|0.941|1.42||||||||1.420|0.941|
91489551|NCT03113916|182852027|SUPERIORITY||Slope|0.174||||0.008|TWO_SIDED|95.0|0.05|0.302|||Mixed Models Analysis|||||.302|.050|.008
91489552|NCT03113916|182852028|SUPERIORITY||Slope|0.015||||0.5|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|||||.059|-.029|.50
91489553|NCT03113916|182852029|SUPERIORITY||Slope|-0.00003||||0.99|TWO_SIDED|95.0|-0.013|0.013|||Mixed Models Analysis|||||.013|-.013|.99
91489554|NCT01758523|182852034|OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91489555|NCT01758523|182852035|OTHER|||||||0.028|||||||Mixed Models Analysis|||||||0.028
91489556|NCT01758523|182852036|OTHER||Odds Ratio (OR)|2.49||||0.057|TWO_SIDED|95.0|0.96|6.45|||Chi-squared|||||6.45|0.96|0.057
91723250|NCT02903914|183340254|OTHER||pairwise GMR|0.976|||||TWO_SIDED|90.0|0.794|1.198||||||||1.198|0.794|
91723251|NCT02903914|183340254|OTHER||pairwise GMR|1.233|||||TWO_SIDED|90.0|1.012|1.503||||||||1.503|1.012|
91489557|NCT01758523|182852037|OTHER||Odds Ratio (OR)|5.5||||0.007|TWO_SIDED|95.0|1.5|20.7|||Fisher Exact|||||20.7|1.5|0.007
91489558|NCT01758523|182852038|OTHER|||||||0.87||||||significance for drug x AKR1C3\*2 G-carrier genotype|Mixed Models Analysis|||||||0.87
91489559|NCT01758523|182852039|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.030
91489560|NCT01893203|182852040|SUPERIORITY_OR_OTHER|||||||0.375|||||||McNemar|||||||0.375
91489561|NCT00945893|182852089|NON_INFERIORITY_OR_EQUIVALENCE|The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.|Rate difference|0.0|||||TWO_SIDED|95.0|-6.0|1.9|||Score|||The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): Rate Difference ≥ 10%, HA (alternative): Rate Difference \< 10%||1.9|-6.0|
91489562|NCT00945893|182852090|SUPERIORITY_OR_OTHER||rate difference|2.5|||||TWO_SIDED|95.0|-8.8|7.7|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||7.7|-8.8|
91489563|NCT00945893|182852091|SUPERIORITY_OR_OTHER||rate difference|6.1|||||TWO_SIDED|95.0|-5.6|12.6|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).||12.6|-5.6|
91489564|NCT00945893|182852092|SUPERIORITY_OR_OTHER||rate difference|9.3|||||TWO_SIDED|95.0|-0.8|16.3|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||16.3|-0.8|
91489565|NCT00945893|182852093|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|10.0|||||TWO_SIDED|95.0|-4.1|22.8|||Score|||||22.8|-4.1|
91489566|NCT00945893|182852096|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|0.4|||||TWO_SIDED|95.0|-13.9|14.5|||Score|||||14.5|-13.9|
91489567|NCT00945893|182852099|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|-0.5|||||TWO_SIDED|95.0|-14.7|11.8|||Score|||||11.8|-14.7|
91489568|NCT00945893|182852102|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|2.0|||||TWO_SIDED|95.0|-12.6|14.9|||Score|||||14.9|-12.6|
91489569|NCT00945893|182852111|SUPERIORITY_OR_OTHER||rate difference|5.8|||||TWO_SIDED|95.0|-7.7|13.8|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||13.8|-7.7|
91489570|NCT00945893|182852112|SUPERIORITY_OR_OTHER||rate difference|-6.0|||||TWO_SIDED|95.0|-23.5|5.3|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||5.3|-23.5|
91489571|NCT00945893|182852113|SUPERIORITY_OR_OTHER||rate difference|2.4|||||TWO_SIDED|95.0|-9.3|10.8|||score|||The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||10.8|-9.3|
91489572|NCT01611155|182852117|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
91489573|NCT01611155|182852118|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||Motor subscale||||0.53
91489574|NCT01611155|182852118|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||autonomic subscale||||0.89
91489575|NCT01435603|182852120|SUPERIORITY||Slope|-1.273||||0.017|TWO_SIDED||||||Regression, Linear|||||||0.017
91489576|NCT01681472|182852156|SUPERIORITY|||||||0.0323|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0323
91723252|NCT02903914|183340255|OTHER|||||||0.1705|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1705
91723253|NCT02903914|183340255|OTHER||pairwise GMR|1.083|||||TWO_SIDED|90.0|0.863|1.359||||||||1.359|0.863|
91723254|NCT02903914|183340255|OTHER||pairwise GMR|0.902|||||TWO_SIDED|90.0|0.719|1.132||||||||1.132|0.719|
91723255|NCT02903914|183340255|OTHER||pairwise GMR|1.212|||||TWO_SIDED|90.0|0.945|1.554||||||||1.554|0.945|
91723256|NCT02903914|183340259|OTHER||pairwise GMR|1.057||||0.7702|TWO_SIDED|90.0|0.753|1.483|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.483|0.753|0.7702
91723257|NCT02903914|183340259|OTHER||pairwise GMR|1.012||||0.9384|TWO_SIDED|90.0|0.762|1.346|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.346|0.762|0.9384
91723258|NCT02903914|183340259|OTHER||pairwise GMR|1.07||||0.6733|TWO_SIDED|90.0|0.809|1.415|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.415|0.809|0.6733
91723259|NCT02903914|183340259|OTHER||pairwise GMR|1.238||||0.3456|TWO_SIDED|90.0|0.83|1.847|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.847|0.830|0.3456
91723260|NCT02903914|183340260|OTHER|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.0441
91723261|NCT02903914|183340260|OTHER|||||||0.4092|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.4092
91723262|NCT02903914|183340260|OTHER|||||||0.7748|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.7748
91723263|NCT02903914|183340260|OTHER|||||||0.1948|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.1948
91723264|NCT02903914|183340261|OTHER||pairwise GMR|0.92||||0.705|TWO_SIDED|90.0|0.62|1.363|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.363|0.620|0.7050
91723265|NCT02903914|183340261|OTHER||pairwise GMR|0.929||||0.703|TWO_SIDED|90.0|0.658|1.31|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.310|0.658|0.7030
91723266|NCT02903914|183340261|OTHER||pairwise GMR|0.999||||0.9952|TWO_SIDED|90.0|0.725|1.377|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.377|0.725|0.9952
91723267|NCT02903914|183340261|OTHER||pairwise GMR|0.742||||0.4012|TWO_SIDED|90.0|0.394|1.397|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.397|0.394|0.4012
91723268|NCT02903914|183340262|OTHER||pairwise GMR|0.992||||0.9623|TWO_SIDED|90.0|0.729|1.349|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.349|0.729|0.9623
91723269|NCT02903914|183340263|OTHER|||||||0.754|||||||Wilcoxon (Mann-Whitney)|||Tablet (test) versus Capsule (reference)||||0.7540
91723270|NCT02903914|183340264|OTHER||pairwise GMR|0.951||||0.7514|TWO_SIDED|90.0|0.718|1.261|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||Tablet (test) versus Capsule (reference)||1.261|0.718|0.7514
91723271|NCT02903914|183340265|OTHER||pairwise GMR|0.954||||0.7707|TWO_SIDED|90.0|0.712|1.277|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.277|0.712|0.7707
91723272|NCT03487445|183340292|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 8 mg is described in statistical analysis 2: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 8 mg dose.|||||<|0.001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.001
91723273|NCT03487445|183340292|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 8 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.142||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.142
91723274|NCT03487445|183340292|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 16 mg is described in statistical analysis 4: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 16 mg dose.|||||<|0.0001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.0001
91723275|NCT03487445|183340292|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 16 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.009||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.009
91723276|NCT03487445|183340293|SUPERIORITY|||||||0.228||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.2280
91723277|NCT03487445|183340293|SUPERIORITY|||||||0.0201||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.0201
91723278|NCT00373672|183340315|SUPERIORITY||||||<|0.016|||||||t-test, 2 sided|||Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.||||<0.016
91723279|NCT04132050|183340316|SUPERIORITY||Difference in Percent of Participants|36.4||||0.03|TWO_SIDED|95.0|3.1|59.3|||Fisher Exact||"The difference in the achievement rate of Stable platelet response (= platelet count of ≥ 50000/μL at 4 or more of the 6 visits from Weeks 14 to 24) between two groups and its two-sided 95% CI were calculated."|||59.3|3.1|0.030
91723280|NCT06717399|183340372|OTHER|The number of participants (n=15) was calculated using an effect size of 0.89. This effect size was based on a randomized clinical trial utilizing a structured mindfulness meditation program on moderate sleep disturbances in older adults (Black et al. 2015). A power of 0.8 and a significance level of 0.05 was utilized to calculate the sample size, a minimum of 12 participants is required to demonstrate significance in this study. To account for 20% attrition total participants needed is 15.||||||0.00058|||||||t-test, 2 sided|||"Null Hypothesis:~● There will not be a change in sleep quality after participation in eight mindfulness meditation sessions as measured by the Pittsburgh Sleep Quality Index."||||0.00058
91723281|NCT06717399|183340373|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
91723282|NCT03043573|183340375|SUPERIORITY||Mean Difference (Final Values)|-0.7011||||0.9644|TWO_SIDED|95.0|-31.8605|30.4583|||t-test, 2 sided|||Baseline||30.4583|-31.8605|0.9644
91723283|NCT03043573|183340375|SUPERIORITY||Mean Difference (Final Values)|2.4595||||0.888|TWO_SIDED|95.0|-32.3472|37.2661|||t-test, 2 sided|||Week 12||37.2661|-32.3472|0.8880
91723284|NCT03043573|183340375|SUPERIORITY||Mean Difference (Final Values)|-0.5119||||0.9773|TWO_SIDED|95.0|-36.5024|35.4785|||t-test, 2 sided|||Week 24||35.4785|-36.5024|0.9773
91723285|NCT03043573|183340375|SUPERIORITY||Mean Difference (Final Values)|15.6667||||0.6173|TWO_SIDED|95.0|-47.0598|78.3931|||t-test, 1 sided|||Week 52||78.3931|-47.0598|0.6173
91723286|NCT03043573|183340376|SUPERIORITY||Mean Difference (Final Values)|1.1302||||0.5454|TWO_SIDED|95.0|-2.5767|4.8371|||t-test, 2 sided|||Baseline||4.8371|-2.5767|0.5454
91723287|NCT03043573|183340376|SUPERIORITY||Mean Difference (Final Values)|2.9618||||0.1212|TWO_SIDED|95.0|-0.8038|6.7275|||t-test, 2 sided|||Week 6||6.7275|-0.8038|0.1212
91723288|NCT03043573|183340376|SUPERIORITY||Mean Difference (Final Values)|1.095||||0.571|TWO_SIDED|95.0|-2.7476|4.9377|||t-test, 2 sided|||Week 12||4.9377|-2.7476|0.5710
91723289|NCT03043573|183340376|SUPERIORITY||Mean Difference (Final Values)|-1.5524||||0.4377|TWO_SIDED|95.0|-5.5256|2.4209|||t-test, 2 sided|||Week 24||2.4209|-5.5256|0.4377
91723290|NCT03043573|183340376|SUPERIORITY||Mean Difference (Final Values)|0.8937||||0.6813|TWO_SIDED|95.0|-3.4439|5.2312|||t-test, 2 sided|||Week 36||5.2312|-3.4439|0.6813
91723291|NCT03043573|183340376|SUPERIORITY||Mean Difference (Final Values)|2.9457||||0.162|TWO_SIDED|95.0|-1.2234|7.1148|||t-test, 2 sided|||||7.1148|-1.2234|0.1620
91723292|NCT03043573|183340377|SUPERIORITY||Mean Difference (Final Values)|0.0319||||0.9813|TWO_SIDED|95.0|-2.6668|2.7305|||t-test, 2 sided|||Baseline||2.7305|-2.6668|0.9813
91489577|NCT01681472|182852156|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
91723293|NCT03043573|183340377|SUPERIORITY||Mean Difference (Final Values)|-0.0564||||0.9735|TWO_SIDED|95.0|-3.4397|3.3268|||t-test, 2 sided|||Week 6||3.3268|-3.4397|0.9735
91723294|NCT03043573|183340377|SUPERIORITY|Week 12|Mean Difference (Final Values)|1.0611||||0.5164|TWO_SIDED|95.0|-2.1885|4.3107|||t-test, 2 sided|||||4.3107|-2.1885|0.5164
91723295|NCT03043573|183340377|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.197|TWO_SIDED|95.0|-5.0651|1.0651|||t-test, 2 sided|||Week 24||1.0651|-5.0651|0.1970
91723296|NCT03043573|183340377|SUPERIORITY||Mean Difference (Net)|0.362||||0.8342|TWO_SIDED|95.0|-3.0907|3.8146|||t-test, 2 sided|||Week 36||3.8146|-3.0907|0.8342
91692835|NCT03581123|183280837|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-14.0|||||TWO_SIDED|95.0|-22.0|-7.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||-7|-22|
91692836|NCT03581123|183280837|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-17.0|||||TWO_SIDED|95.0|-24.0|-9.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||-9|-24|
91692837|NCT03581123|183280838|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-8.0|||||TWO_SIDED|95.0|-13.0|-3.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-3|-13|
91692838|NCT03581123|183280838|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||1|-12|
91692839|NCT03581123|183280838|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||-1|-15|
91692840|NCT03581123|183280845|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-21.0|-4.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-4|-21|
91692841|NCT03581123|183280845|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-22.0|-3.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||-3|-22|
91692842|NCT03581123|183280845|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-22.0|-3.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||-3|-22|
91692843|NCT03581123|183280846|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-20.0|||||TWO_SIDED|95.0|-28.0|-12.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-12|-28|
91692844|NCT03581123|183280846|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-13.0|6.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||6|-13|
91692845|NCT03581123|183280846|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-16.0|||||TWO_SIDED|95.0|-26.0|-7.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||-7|-26|
91692846|NCT03581123|183280847|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-1|-15|
91692847|NCT03581123|183280847|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-22.0|-3.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||-3|-22|
91692848|NCT03581123|183280847|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-22.0|-3.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||-3|-22|
91692849|NCT03581123|183280848|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-5.0|||||SSM - MC|Adjusted for site, time period, and risk of chronicity.||-5|-19|
91692850|NCT03581123|183280848|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-8.0|||||TWO_SIDED|95.0|-16.0|-1.0|||||SMT - MC|Adjusted for site, time period, and risk of chronicity.||-1|-16|
91692851|NCT03581123|183280848|OTHER|Estimation (percentage difference)|Risk Difference (RD)|-8.0|||||TWO_SIDED|95.0|-16.0|1.0|||||SSM/SMT - MC|Adjusted for site, time period, and risk of chronicity.||1|-16|
91489578|NCT01681472|182852156|SUPERIORITY|||||||0.8622|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8622
91489579|NCT01681472|182852156|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91489580|NCT01681472|182852156|SUPERIORITY|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0074
91489581|NCT01681472|182852156|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
91723297|NCT03043573|183340377|SUPERIORITY||Mean Difference (Final Values)|1.2667||||0.4717|TWO_SIDED|95.0|-2.2424|4.7758|||t-test, 2 sided|||Week 52||4.7758|-2.2424|0.4717
91723298|NCT03043573|183340378|SUPERIORITY||Mean Difference (Final Values)|-2.9318||||0.513|TWO_SIDED|95.0|-11.8176|5.9539|||t-test, 2 sided|||Baseline||5.9539|-11.8176|0.5130
91723299|NCT03043573|183340378|SUPERIORITY||Mean Difference (Final Values)|0.4835||||0.4835|TWO_SIDED|95.0|-15.2306|7.2967|||t-test, 2 sided|||Week 12||7.2967|-15.2306|0.4835
91723300|NCT03043573|183340378|SUPERIORITY||Mean Difference (Final Values)|-5.156||||0.359|TWO_SIDED|95.0|-16.3357|6.0238|||t-test, 2 sided|||Week 24||6.0238|-16.3357|0.3590
91723301|NCT03043573|183340378|SUPERIORITY||Mean Difference (Final Values)|1.1083||||0.876|TWO_SIDED|95.0|-13.1598|15.3765|||t-test, 2 sided|||Week 52||15.3765|-13.1598|0.8760
91723302|NCT03043573|183340379|SUPERIORITY||Mean Difference (Final Values)|-0.0606||||0.3248|TWO_SIDED|95.0|-0.1841|0.0628|||t-test, 2 sided|||Trails A Baseline||0.0628|-0.1841|0.3248
91723303|NCT03043573|183340379|SUPERIORITY||Mean Difference (Final Values)|-0.6953||||0.3615|TWO_SIDED|95.0|-2.2261|0.8354|||t-test, 2 sided|||Trails A - Week 12||0.8354|-2.2261|0.3615
91723304|NCT03043573|183340379|SUPERIORITY||Mean Difference (Final Values)|0.9917||||0.5046|TWO_SIDED|95.0|-1.9664|3.9498|||t-test, 2 sided|||Trails B - Baseline||3.9498|-1.9664|0.5046
91723305|NCT03043573|183340379|SUPERIORITY||Mean Difference (Final Values)|-2.0607||||0.0679|TWO_SIDED|95.0|-4.2821|0.1607|||t-test, 2 sided|||Trails B - Week 12||0.1607|-4.2821|0.0679
91723306|NCT03043573|183340379|SUPERIORITY||Mean Difference (Final Values)|-0.8929||||0.1669|TWO_SIDED|95.0|-2.1825|0.3968|||t-test, 2 sided|||Trails B - Week 24||0.3968|-2.1825|0.1669
91723307|NCT03043573|183340379|SUPERIORITY||Mean Difference (Final Values)|-1.4286||||0.2178|TWO_SIDED|95.0|-3.8115|0.9543|||t-test, 2 sided|||Trails B - Week 52||0.9543|-3.8115|0.2178
91723308|NCT03043573|183340380|SUPERIORITY||Mean Difference (Final Values)|1.558||||0.2932|TWO_SIDED|95.0|-1.3747|4.4908|||t-test, 2 sided|||Baseline||4.4908|-1.3747|0.2932
91723309|NCT03043573|183340380|SUPERIORITY||Mean Difference (Final Values)|1.7043||||0.2871|TWO_SIDED|95.0|-1.4659|4.8744|||t-test, 2 sided|||Week 6||4.8744|-1.4659|0.2871
91723310|NCT03043573|183340380|SUPERIORITY||Mean Difference (Final Values)|0.9167||||0.591|TWO_SIDED|95.0|-2.4737|4.307|||t-test, 2 sided|||Week 12||4.3070|-2.4737|0.5910
91723311|NCT03043573|183340380|SUPERIORITY||Mean Difference (Final Values)|-1.0238||||0.6128|TWO_SIDED|95.0|-5.0469|2.9993|||t-test, 2 sided|||||2.9993|-5.0469|0.6128
91489582|NCT01681472|182852157|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1480
91723312|NCT03043573|183340380|SUPERIORITY||Mean Difference (Final Values)|1.9276||||0.3326|TWO_SIDED|95.0|-2.0231|5.8783|||t-test, 2 sided|||Week 36||5.8783|-2.0231|0.3326
91723313|NCT03043573|183340380|SUPERIORITY||Mean Difference (Final Values)|2.0741||||0.2935|TWO_SIDED|95.0|-1.8522|6.0004|||t-test, 2 sided|||Week 52||6.0004|-1.8522|0.2935
91723314|NCT00639379|183340396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.65|Odds Ratio (OR)|0.967|||||TWO_SIDED|98.98|0.436|0.967|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.||0.967|0.436|
91723315|NCT00639379|183340397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.65|Odds Ratio (OR)|1.416|||||TWO_SIDED|98.98|0.68|1.416|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.||1.416|0.680|
91723316|NCT00639379|183340398|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|0.1868|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|98.98|-0.0517|0.1868|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.||0.1868|-0.0517|
91723317|NCT00639379|183340399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|-0.01185|STANDARD_ERROR_OF_MEAN|0.08566|||TWO_SIDED|98.98|-0.2337|-0.01185|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.||-0.01185|-0.2337|
91723318|NCT00639379|183340400|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.01267|STANDARD_ERROR_OF_MEAN|0.01265|||TWO_SIDED|98.98|-0.01267|0.01986|||||The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.||0.01986|-0.01267|
91723319|NCT01033942|183340402|SUPERIORITY_OR_OTHER|||||||0.6983||||||The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.|Chi-squared|||||||0.6983
91723320|NCT01033942|183340403|SUPERIORITY_OR_OTHER|||||||0.8722|TWO_SIDED||||||Fisher Exact|||||||0.8722
91723321|NCT01033942|183340404|SUPERIORITY_OR_OTHER|||||||0.6921||||||Not all subjects answered every question.|Fisher Exact|||||||0.6921
91723322|NCT01033942|183340405|SUPERIORITY_OR_OTHER|||||||0.4655||||||Not all participants answered every question|Fisher Exact|||||||0.4655
91723323|NCT01033942|183340406|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.9999
91723324|NCT01033942|183340407|SUPERIORITY_OR_OTHER|||||||0.2297|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.2297
91723325|NCT01033942|183340408|SUPERIORITY_OR_OTHER|||||||0.1886||||||Not all participants answered every question|Fisher Exact|||||||0.1886
91723326|NCT01033942|183340409|SUPERIORITY_OR_OTHER|||||||0.1908|||||||Fisher Exact|||||||0.1908
91489583|NCT01681472|182852157|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
91489584|NCT01681472|182852157|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
91527920|NCT01065350|182930857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.7|||<|0.001|TWO_SIDED|95.0|7.5|20.0|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||20.0|7.5|<0.001
91723327|NCT01033942|183340410|SUPERIORITY_OR_OTHER|||||||0.224||||||Not all participants answered every question|Fisher Exact|||||||0.2240
91723328|NCT01033942|183340411|SUPERIORITY_OR_OTHER|||||||0.1538||||||Not all participants answered every question|Fisher Exact|||||||0.1538
91723329|NCT01033942|183340412|SUPERIORITY_OR_OTHER|||||||0.2151||||||Not all participants answered every question|Fisher Exact|||||||0.2151
91489585|NCT01681472|182852157|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
91489586|NCT01681472|182852157|SUPERIORITY|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0019
91723330|NCT01033942|183340413|SUPERIORITY_OR_OTHER|||||||0.2809||||||Not all participants answered every question|Fisher Exact|||||||0.2809
91723331|NCT01033942|183340414|SUPERIORITY_OR_OTHER|||||||0.185||||||Not all participants answered every question|Fisher Exact|||||||0.1850
91723332|NCT01033942|183340415|SUPERIORITY_OR_OTHER|||||||0.2366||||||Not all participants answered every question|Fisher Exact|||||||0.2366
91723333|NCT01033942|183340416|SUPERIORITY_OR_OTHER|||||||0.4089||||||Not all subjects answered every question.|Fisher Exact|||||||0.4089
91723334|NCT01033942|183340417|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723335|NCT01033942|183340418|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723336|NCT01033942|183340419|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723337|NCT01033942|183340420|SUPERIORITY_OR_OTHER|||||||0.7007|||||||Fisher Exact|||||||0.7007
91723338|NCT01033942|183340421|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723339|NCT01033942|183340422|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723340|NCT01033942|183340423|SUPERIORITY_OR_OTHER|||||||0.8934|||||||Chi-squared|||||||0.8934
91723341|NCT01033942|183340424|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723342|NCT01033942|183340425|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723343|NCT01033942|183340426|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
91723344|NCT01033942|183340427|SUPERIORITY_OR_OTHER|||||||0.4003|||||||Fisher Exact|||||||0.4003
91723345|NCT01033942|183340428|SUPERIORITY_OR_OTHER|||||||0.6462|||||||Fisher Exact|||||||0.6462
91723346|NCT01033942|183340429|SUPERIORITY_OR_OTHER|||||||0.8505|||||||Chi-squared|||||||0.8505
91723347|NCT01033942|183340437|SUPERIORITY_OR_OTHER|||||||0.7434|TWO_SIDED||||||Chi-squared|||||||0.7434
91723348|NCT01033942|183340438|SUPERIORITY_OR_OTHER|||||||0.6153|TWO_SIDED||||||Chi-squared|||||||0.6153
91723349|NCT01033942|183340439|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||||||0.2000
91723350|NCT01033942|183340440|SUPERIORITY_OR_OTHER|||||||0.5265|TWO_SIDED||||||Chi-squared|||||||0.5265
91723351|NCT01033942|183340441|SUPERIORITY_OR_OTHER|||||||0.2559|TWO_SIDED||||||Chi-squared|||||||0.2559
91723352|NCT01033942|183340442|SUPERIORITY_OR_OTHER|||||||0.3846|TWO_SIDED||||||Chi-squared|||||||0.3846
91723353|NCT01033942|183340443|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||Chi-squared|||||||0.5133
91723354|NCT01033942|183340444|SUPERIORITY_OR_OTHER|||||||0.1661|TWO_SIDED||||||Chi-squared|||||||0.1661
91723355|NCT01033942|183340445|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED||||||Chi-squared|||||||0.0729
91723356|NCT01033942|183340446|SUPERIORITY_OR_OTHER|||||||0.1912|TWO_SIDED||||||Chi-squared|||||||0.1912
91723357|NCT01033942|183340447|SUPERIORITY_OR_OTHER|||||||0.2829|TWO_SIDED||||||Chi-squared|||||||0.2829
91723358|NCT01033942|183340448|SUPERIORITY_OR_OTHER|||||||0.2685|TWO_SIDED||||||Chi-squared|||||||0.2685
91723359|NCT01033942|183340449|SUPERIORITY_OR_OTHER|||||||0.2342|TWO_SIDED||||||Chi-squared|||||||0.2342
91723360|NCT01033942|183340450|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Fisher Exact|||||||0.7314
91723361|NCT01033942|183340451|SUPERIORITY_OR_OTHER|||||||0.377|||||||Fisher Exact|||||||0.3770
91723362|NCT01033942|183340452|SUPERIORITY_OR_OTHER|||||||0.7004|||||||Fisher Exact|||||||0.7004
91489587|NCT01681472|182852157|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
91723363|NCT01033942|183340453|SUPERIORITY_OR_OTHER|||||||0.4668|||||||Fisher Exact|||||||0.4668
91723364|NCT01033942|183340454|SUPERIORITY_OR_OTHER|||||||0.7573|||||||Fisher Exact|||||||0.7573
91723365|NCT01033942|183340455|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Fisher Exact|||||||0.0356
91723366|NCT01033942|183340456|SUPERIORITY_OR_OTHER|||||||0.3176|||||||Fisher Exact|||||||0.3176
91723367|NCT01033942|183340457|SUPERIORITY_OR_OTHER|||||||0.1348|||||||Fisher Exact|||||||0.1348
91723368|NCT01033942|183340458|SUPERIORITY_OR_OTHER|||||||0.042|||||||Fisher Exact|||||||0.0420
91723369|NCT01033942|183340459|SUPERIORITY_OR_OTHER|||||||0.4906|||||||Fisher Exact|||||||0.4906
91723370|NCT01033942|183340460|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Fisher Exact|||||||0.0544
91723371|NCT01033942|183340461|SUPERIORITY_OR_OTHER|||||||0.5645|||||||Fisher Exact|||||||0.5645
91489588|NCT01681472|182852158|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
91723372|NCT01033942|183340462|SUPERIORITY_OR_OTHER|||||||0.7847|||||||Fisher Exact|||||||0.7847
91723373|NCT01033942|183340463|SUPERIORITY_OR_OTHER|||||||0.0288|||||||Fisher Exact|||||||0.0288
91723374|NCT01033942|183340464|SUPERIORITY_OR_OTHER|||||||0.0945|||||||Fisher Exact|||||||0.0945
91723375|NCT01033942|183340465|SUPERIORITY_OR_OTHER|||||||0.3884|||||||Fisher Exact|||||||0.3884
91723376|NCT01033942|183340466|SUPERIORITY_OR_OTHER|||||||0.2235|||||||Fisher Exact|||||||0.2235
91723377|NCT01033942|183340467|SUPERIORITY_OR_OTHER|||||||0.0467|||||||Fisher Exact|||||||0.0467
91723378|NCT01033942|183340468|SUPERIORITY_OR_OTHER|||||||0.6331|||||||Fisher Exact|||||||0.6331
91723379|NCT01033942|183340469|SUPERIORITY_OR_OTHER|||||||0.0948|||||||Fisher Exact|||||||0.0948
91723380|NCT01033942|183340470|SUPERIORITY_OR_OTHER|||||||0.5826|||||||Fisher Exact|||||||0.5826
91723381|NCT01033942|183340471|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Fisher Exact|||||||0.0087
91723382|NCT01033942|183340472|SUPERIORITY_OR_OTHER|||||||0.1934|||||||Fisher Exact|||||||0.1934
91723383|NCT01033942|183340473|SUPERIORITY_OR_OTHER|||||||0.2146|||||||Fisher Exact|||||||0.2146
91723384|NCT01033942|183340474|SUPERIORITY_OR_OTHER|||||||0.5317|||||||Fisher Exact|||||||0.5317
91723385|NCT01033942|183340475|SUPERIORITY_OR_OTHER|||||||0.1733|||||||Fisher Exact|||||||0.1733
91723386|NCT01033942|183340476|SUPERIORITY_OR_OTHER|||||||0.1747|||||||Fisher Exact|||||||0.1747
91723387|NCT01033942|183340477|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Fisher Exact|||||||0.1203
91723388|NCT01033942|183340478|SUPERIORITY_OR_OTHER|||||||0.8243|||||||Fisher Exact|||||||0.8243
91723389|NCT01033942|183340479|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Fisher Exact|||||||0.6202
91723390|NCT01033942|183340480|SUPERIORITY_OR_OTHER|||||||0.8351|||||||Fisher Exact|||||||0.8351
91723391|NCT01033942|183340481|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Fisher Exact|||||||0.0484
91723392|NCT01033942|183340482|SUPERIORITY_OR_OTHER|||||||0.4207|||||||Fisher Exact|||||||0.4207
91723393|NCT01033942|183340483|SUPERIORITY_OR_OTHER|||||||0.2187|||||||Fisher Exact|||||||0.2187
91723394|NCT01033942|183340484|SUPERIORITY_OR_OTHER|||||||0.5369|||||||Fisher Exact|||||||0.5369
91723395|NCT01033942|183340485|SUPERIORITY_OR_OTHER|||||||0.1524|||||||Fisher Exact|||||||0.1524
91723396|NCT01033942|183340486|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.4700
91723397|NCT01033942|183340487|SUPERIORITY_OR_OTHER|||||||0.4686|||||||Fisher Exact|||||||0.4686
91723398|NCT01033942|183340488|SUPERIORITY_OR_OTHER|||||||0.3791|||||||Fisher Exact|||||||0.3791
91723399|NCT01033942|183340489|SUPERIORITY_OR_OTHER|||||||0.7374|||||||Fisher Exact|||||||0.7374
91723400|NCT01033942|183340490|SUPERIORITY_OR_OTHER|||||||0.9363|||||||Fisher Exact|||||||0.9363
91723401|NCT01033942|183340491|SUPERIORITY_OR_OTHER|||||||0.6267|||||||Fisher Exact|||||||0.6267
91723402|NCT01033942|183340492|SUPERIORITY_OR_OTHER|||||||0.6434|TWO_SIDED||||||Fisher Exact|||||||0.6434
91723403|NCT01033942|183340493|SUPERIORITY_OR_OTHER|||||||0.8582|TWO_SIDED||||||Fisher Exact|||||||0.8582
91723404|NCT01033942|183340494|SUPERIORITY_OR_OTHER|||||||0.5778|TWO_SIDED||||||Fisher Exact|||||||0.5778
91723405|NCT01033942|183340495|SUPERIORITY_OR_OTHER|||||||0.9881|TWO_SIDED||||||Fisher Exact|||||||0.9881
91723406|NCT01033942|183340496|SUPERIORITY_OR_OTHER|||||||0.9771|TWO_SIDED||||||Fisher Exact|||||||0.9771
91723407|NCT01033942|183340497|SUPERIORITY_OR_OTHER|||||||0.2301|TWO_SIDED||||||Fisher Exact|||||||0.2301
91723408|NCT01115231|183340500|OTHER|multivariable logistic regression model|Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.93|4.42||||||||4.42|0.93|
91723409|NCT02493855|183340521|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.311|||||||Wilcoxon Rank Sum Test|||||||0.311
91723410|NCT02493855|183340521|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.561|||||||Wilcoxon Rank Sum Test|||||||0.561
91723411|NCT02299167|183340522|OTHER|The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Mean (95% CI) of effective dose in 90% (|1.9|||||TWO_SIDED|95.0|1.7|2.1|||||The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction||2.1|1.7|
91723412|NCT04868682|183340555|SUPERIORITY||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.32||0.0001|TWO_SIDED|95.0|0.65|1.91|||t-test, 2 sided||The parameter estimate is the difference in means (treatment vs. control) during the first 180 nights following randomization.|||1.91|0.65|.0001
91723413|NCT04868682|183340556|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.81||0.378|TWO_SIDED|95.0|-2.29|0.87|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 6-months for the treatment group versus the same improvement in respect to the control group.|||0.87|-2.29|0.378
91489589|NCT01681472|182852158|SUPERIORITY|||||||0.0538|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0538
91723414|NCT04868682|183340557|SUPERIORITY||Mean Difference (Net)|-2.78|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|-4.09|-1.27|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 6-months for the treatment group versus the same improvement in respect to the control group.|||-1.27|-4.09|<0.001
91489590|NCT01681472|182852158|SUPERIORITY|||||||0.5244|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5244
91489591|NCT01681472|182852158|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
91723415|NCT04868682|183340558|SUPERIORITY||Median Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.66||0.865|TWO_SIDED|95.0|-1.4|1.18|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 6-months for the treatment group versus the same improvement in respect to the control group.|||1.18|-1.40|0.865
91489592|NCT01681472|182852158|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0313
91527921|NCT01065350|182930857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.017|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.017
91723416|NCT00063622|183340559|SUPERIORITY_OR_OTHER|||||||0.001||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.001
91723417|NCT00063622|183340559|SUPERIORITY_OR_OTHER|||||||0.04||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.04
91723418|NCT00063622|183340560|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.005
91489593|NCT01681472|182852158|SUPERIORITY|||||||0.4777|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4777
91489594|NCT01681472|182852159|SUPERIORITY|||||||0.2716|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2716
91489595|NCT01681472|182852159|SUPERIORITY|||||||0.0124|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0124
91723419|NCT00063622|183340560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91723420|NCT00063622|183340561|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.02
91723421|NCT00063622|183340561|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
91723422|NCT00063622|183340562|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||||||0.01
91723423|NCT00063622|183340562|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
91723424|NCT00063622|183340563|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
91723425|NCT00063622|183340563|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
91723426|NCT00063622|183340564|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||||||0.05
91723427|NCT00063622|183340564|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
91723428|NCT02202616|183340569|OTHER||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|0.14|0.21|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.21|0.14|
91723429|NCT02202616|183340570|OTHER||Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.278|||TWO_SIDED|95.0|0.11|0.17|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.17|0.11|
91723430|NCT02202616|183340571|OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.47|||TWO_SIDED|95.0|1.74|2.3|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit.||Week 4||2.30|1.74|
91723431|NCT02202616|183340571|OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.92|||TWO_SIDED|95.0|2.21|2.85|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit||Week 16||2.85|2.21|
91723432|NCT02202616|183340572|OTHER||Mean Difference (Final Values)|-5.0|STANDARD_DEVIATION|6.25|||TWO_SIDED|95.0|-5.7|-4.3|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 4||-4.3|-5.7|
91723433|NCT02202616|183340572|OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|7.03|||TWO_SIDED|95.0|-7.3|-5.7|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 16||-5.7|-7.3|
91723434|NCT04327271|183340582|NON_INFERIORITY|Non-inferiority margin of -0.25% set as lower bound of 95% CI for the maximum mean difference between the proportion of cumulative AEs between control and 2wT arms to conclude that 2wT is non-inferior. This margin was set considering the average AE rate of 0.5% from routine SSA MC programs at scale, and assuming that 2wT increases AE ascertainment to 2.0%, similar to 1.9% of Zimbabwe RCT and the widely-accepted standard 2% AE rate.|Mean Difference (Final Values)|1.2|||||ONE_SIDED|95.0|-0.09|||||||With 10% loss to follow-up (LTFU), a sample size of 1104 men provides at least 80% power to rule out a decrease in AE ascertainment of more than 0.25% based on the lower bound of the one-sided 95% CI. The one tailed alpha was set 0.05.|||-.09|
91723435|NCT04327271|183340583|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.001|TWO_SIDED|95.0|1.03|1.21|||Fisher Exact|||The mean number of in-person clinic visit, excluding non-study visits, were compared between the two arms using a t-test. The proportion of potential AEs was calculated as number of potential AE responses divided by the total number of daily responses (no AE and potential AE). A superiority test was performed on the safety outcomes using a two-sided 95% confidence interval and p-value using Fisher's exact test.||1.21|1.03|0.001
91723436|NCT02320175|183340614|OTHER|We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies.|||||<|0.05|||||||GEE chi-squared test for binary outcomes|||||||<.05
91723437|NCT04871074|183340692|SUPERIORITY|||||||0.74|||||||DeLong's Test|||||||.74
91723438|NCT04871074|183340693|SUPERIORITY|||||||0.66|||||||DeLong's Test|||||||.66
91723439|NCT04871074|183340694|SUPERIORITY|||||||0.135|||||||Mixed Models Analysis|Linear mixed effects model, fixed effects coefficient test with a Wald test||||||.135
91723440|NCT04871074|183340698|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Fixed effects estimate, Wald test||||||.39
91723441|NCT02516241|183340758|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0751|TWO_SIDED|98.66|0.688|1.063||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.063|0.688|0.0751
91723442|NCT02516241|183340759|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.3039|TWO_SIDED|96.99|0.695|1.139||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.139|0.695|0.3039
91723443|NCT02516241|183340760|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8637|TWO_SIDED|95.0|0.83|1.169||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.169|0.830|0.8637
91723444|NCT02516241|183340761|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0091|TWO_SIDED|95.0|0.589|0.928||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.928|0.589|0.0091
91723445|NCT02516241|183340762|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7599|TWO_SIDED|95.0|0.799|1.359||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.359|0.799|0.7599
91723446|NCT02516241|183340762|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4424|TWO_SIDED|95.0|0.692|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.175|0.692|0.4424
91723447|NCT02516241|183340766|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.2579|TWO_SIDED|95.0|0.931|1.304||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.304|0.931|0.2579
91723448|NCT02516241|183340766|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0008|TWO_SIDED|95.0|1.124|1.567||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.567|1.124|0.0008
91723449|NCT02516241|183340767|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.2395|TWO_SIDED|95.0|0.705|1.091||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.091|0.705|0.2395
91692852|NCT04195685|183280868|OTHER||Mean Difference (Final Values)|10.7|||<|0.0001|TWO_SIDED|95.0|7.0|14.4|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||14.4|7.0|<.0001
91692853|NCT04195685|183280869|OTHER||Mean Difference (Final Values)|9.5|||<|0.0001|TWO_SIDED|95.0|4.9|14.0|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||14.0|4.9|<.0001
91489596|NCT01681472|182852159|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
91489597|NCT01681472|182852159|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
91489598|NCT01681472|182852159|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0039
91489599|NCT01681472|182852159|SUPERIORITY|||||||0.0454|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0454
91489600|NCT01681472|182852160|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0092
91489601|NCT01681472|182852160|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8303
91489602|NCT01681472|182852160|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
91489603|NCT01681472|182852160|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
91489604|NCT01681472|182852160|SUPERIORITY|||||||0.3184|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3184
91489605|NCT01681472|182852160|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
91489606|NCT01681472|182852161|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
91489607|NCT01681472|182852161|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
91489608|NCT01681472|182852161|SUPERIORITY|||||||0.0428|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0428
91489609|NCT01681472|182852161|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0003
91489610|NCT01681472|182852161|SUPERIORITY|||||||0.4309|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4309
91489611|NCT01681472|182852161|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
91489612|NCT01681472|182852162|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
91489613|NCT01681472|182852162|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
91723450|NCT02516241|183340767|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.2431|TWO_SIDED|95.0|0.917|1.406||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.406|0.917|0.2431
91723451|NCT02516241|183340768|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.0014|TWO_SIDED|95.0|1.177|1.99||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.990|1.177|0.0014
91723452|NCT02516241|183340768|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6236|TWO_SIDED|95.0|0.729|1.209||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.209|0.729|0.6236
91723453|NCT02516241|183340772|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0477|TWO_SIDED|95.0|0.683|0.998||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.998|0.683|0.0477
91723454|NCT02516241|183340772|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7885|TWO_SIDED|95.0|0.809|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.175|0.809|0.7885
91723455|NCT02516241|183340773|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0053|TWO_SIDED|95.0|0.549|0.901||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.901|0.549|0.0053
91723456|NCT02516241|183340773|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1336|TWO_SIDED|95.0|0.651|1.059||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.059|0.651|0.1336
91692854|NCT04195685|183280870|OTHER||Mean Difference (Final Values)|10.3|||<|0.0001|TWO_SIDED|95.0|7.4|13.2|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||13.2|7.4|<.0001
91692855|NCT04195685|183280871|OTHER||Mean Difference (Final Values)|7.4|||<|0.0001|TWO_SIDED|95.0|4.2|10.6|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||10.6|4.2|<.0001
91692856|NCT04195685|183280872|OTHER||Mean Difference (Final Values)|-32.5||||0.0022|TWO_SIDED|95.0|-53.3|-11.7|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||-11.7|-53.3|0.0022
91692857|NCT04195685|183280873|OTHER||Mean Difference (Final Values)|-32.2|||<|0.0001|TWO_SIDED|95.0|-45.0|-19.4|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||-19.4|-45.0|<.0001
91692858|NCT04195685|183280874|OTHER||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.1|-3.4|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||-3.4|-11.1|0.0002
91692859|NCT04195685|183280875|OTHER||Mean Difference (Final Values)|-6.2|||<|0.0001|TWO_SIDED|95.0|-9.0|-3.4|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||-3.4|-9.0|<.0001
91692860|NCT04195685|183280876|OTHER||Mean Difference (Final Values)|-4.5||||0.0033|TWO_SIDED|95.0|-7.4|-1.5|||t-test, 2 sided|||||-1.5|-7.4|0.0033
91723457|NCT02516241|183340774|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8148|TWO_SIDED|95.0|0.772|1.391||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.391|0.772|0.8148
91723458|NCT02516241|183340774|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.2684|TWO_SIDED|95.0|0.636|1.134||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.134|0.636|0.2684
91527922|NCT01065350|182930858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.01|TWO_SIDED|95.0|2.7|11.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||11.5|2.7|<0.01
91692861|NCT04195685|183280877|OTHER||Mean Difference (Final Values)|10.0||||0.0005|TWO_SIDED|95.0|4.4|15.6|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||15.6|4.4|0.0005
91692862|NCT04195685|183280878|OTHER||Mean Difference (Final Values)|6.4|||<|0.0001|TWO_SIDED|95.0|3.5|9.2|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||9.2|3.5|<.0001
91692863|NCT04195685|183280879|OTHER||Mean Difference (Final Values)|14.2||||0.0001|TWO_SIDED|95.0|7.1|21.4|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||21.4|7.1|0.0001
91692864|NCT04195685|183280880|OTHER||Mean Difference (Final Values)|68.0|||<|0.0001|TWO_SIDED|95.0|36.9|99.2|||t-test, 2 sided|||The primary endpoint was evaluated by assessing the change in severity scores from baseline to the end of treatment, comparing the NFB and control groups. A two-sample t-test was used to test the mean change in severity scores between treatment arms. Statistical tests were two-sided with a 5% significance level (Type I error rate).||99.2|36.9|<.0001
91692865|NCT00216125|183280881|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.883|TWO_SIDED|95.0|||||Log Rank|||||||0.883
91692866|NCT03448419|183280883|SUPERIORITY||Median difference (HL-estimate)|-4.0||||0.4236|TWO_SIDED|95.0|-16.0|6.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||6.0|-16.0|0.4236
91692867|NCT03448419|183280884|SUPERIORITY||Median difference (HL-estimate)|3.13||||0.0893|TWO_SIDED|95.0|0.0|7.29|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||7.29|0.00|0.0893
91692868|NCT03448419|183280885|SUPERIORITY||Median Difference (HL-estimate)|0.1||||0.4702|TWO_SIDED|95.0|-0.2|0.4|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||0.40|-0.20|0.4702
91692869|NCT03448419|183280886|SUPERIORITY||Median difference (HL-estimate)|0.0||||0.983|TWO_SIDED|95.0|-9.0|9.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||9.0|-9.0|0.9830
91692870|NCT03448419|183280887|OTHER||Difference of adjusted means|-0.31||||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||Mixed Model repeated Measures (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||-0.09|-0.53|0.0053
91692871|NCT03448419|183280888|OTHER|||||||0.6189|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6189
91692872|NCT03448419|183280889|OTHER|||||||0.6672|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6672
91692873|NCT03448419|183280890|OTHER|||||||0.5147|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5147
91723459|NCT02516241|183340775|SUPERIORITY||Odds Ratio (OR)|0.58||||0.0005|TWO_SIDED|95.0|0.422|0.788||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.788|0.422|0.0005
91759980|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-9.49|9.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.03|-9.49|
91527923|NCT01065350|182930858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.042|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.042
91527924|NCT01065350|182930859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.001|TWO_SIDED|95.0|4.8|13.9|||t-test, 2 sided|||Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||13.9|4.8|<0.001
91692874|NCT03448419|183280891|OTHER|||||||0.863|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.8630
91692875|NCT03448419|183280892|OTHER||Adjusted geometric mean ratio|0.91||||0.141|TWO_SIDED|95.0|0.81|1.03|||Mixed Model repeated Measures (MMRM)|Covariates: NT-proBNP-by-visit interaction and visit-by-treatment interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|The endpoint 'relative change from baseline in NT-proBNP at Week 12' (after log-transformation) was evaluated using an MMRM analysis over time with baseline log-transformed NT-proBNP-by-visit interaction and visit-by-treatment interaction as covariates.Unstructured covariance structure was used to model within-patient errors.||1.03|0.81|0.1410
91527925|NCT01065350|182930859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.013|TWO_SIDED|95.0|1.4|11.3|||t-test, 2 sided|||Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.||11.3|1.4|0.013
91489614|NCT01681472|182852162|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489615|NCT01681472|182852162|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91489616|NCT01681472|182852162|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
91489617|NCT01681472|182852162|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
91489618|NCT01681472|182852163|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
91489619|NCT01681472|182852163|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
91527926|NCT01065350|182930860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.6|||<|0.01|TWO_SIDED|95.0|28.1|199.1|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.||199.1|28.1|<0.01
91489620|NCT01681472|182852163|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489621|NCT01681472|182852163|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
91692876|NCT04548193|183280896|SUPERIORITY||Mean Difference (Final Values)|6.14||||0.28|TWO_SIDED|95.0|-5.72|17.99|||Wilcoxon (Mann-Whitney)|||||17.99|-5.72|0.28
91692877|NCT04548193|183280897|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.0054|TWO_SIDED|95.0|0.06|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.06|.0054
91692878|NCT04548193|183280899|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0098|TWO_SIDED|95.0|0.24|1.65|||Wilcoxon (Mann-Whitney)|||||1.65|0.24|.0098
91692879|NCT00630825|183280900|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692880|NCT00630825|183280900|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692881|NCT00630825|183280900|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692882|NCT00630825|183280901|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692883|NCT00630825|183280901|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692884|NCT00630825|183280901|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692885|NCT00630825|183280902|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91489622|NCT01681472|182852163|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
91489623|NCT01681472|182852163|SUPERIORITY|||||||0.0338|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0338
91489624|NCT01681472|182852164|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91692886|NCT00630825|183280902|SUPERIORITY_OR_OTHER|||||||0.047||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
91692887|NCT00630825|183280902|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.025
91692888|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692889|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692890|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692891|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692892|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692893|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91723460|NCT02516241|183340775|SUPERIORITY||Odds Ratio (OR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.253|0.485||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.485|0.253|<0.0001
91723461|NCT02516241|183340776|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7708|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7708
91723462|NCT02516241|183340776|SUPERIORITY||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.268|0.61||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.610|0.268|<0.0001
91723463|NCT02516241|183340777|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.135|0.406||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.406|0.135|<0.0001
91723464|NCT02516241|183340777|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6195|TWO_SIDED|95.0|0.469|1.566||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.566|0.469|0.6195
91489625|NCT01681472|182852164|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91692894|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692895|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692896|NCT00630825|183280903|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692897|NCT00630825|183280904|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692898|NCT00630825|183280904|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692899|NCT00630825|183280904|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
91692900|NCT00630825|183280904|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.904
91692901|NCT00630825|183280904|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.||||||0.138
91723465|NCT02516241|183340779|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0002|TWO_SIDED|95.0|0.41|0.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.759|0.410|0.0002
91723466|NCT02516241|183340779|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.267|0.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.500|0.267|<0.0001
91723467|NCT02516241|183340780|SUPERIORITY||Odds Ratio (OR)|0.87||||0.4959|TWO_SIDED|95.0|0.59|1.291||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.291|0.590|0.4959
91723468|NCT02516241|183340780|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.305|0.679||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.679|0.305|0.0001
91723469|NCT02516241|183340781|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.16|0.448||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.448|0.160|<0.0001
91723470|NCT02516241|183340781|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8074|TWO_SIDED|95.0|0.623|1.836||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.836|0.623|0.8074
91723471|NCT02516241|183340782|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0008|TWO_SIDED|95.0|0.432|0.802||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.802|0.432|0.0008
91723472|NCT02516241|183340782|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.27|0.512||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.512|0.270|<0.0001
91723473|NCT02516241|183340783|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7717|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7717
91723474|NCT02516241|183340783|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.303|0.682||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.682|0.303|0.0001
91723475|NCT02516241|183340784|SUPERIORITY||Odds Ratio (OR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.151|0.439||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.439|0.151|<0.0001
91692902|NCT00630825|183280904|SUPERIORITY_OR_OTHER|||||||0.729||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.729
91692903|NCT00630825|183280906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91489626|NCT01681472|182852164|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91692904|NCT00630825|183280906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692905|NCT00630825|183280906|SUPERIORITY_OR_OTHER|||||||0.113||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.113
91692906|NCT00630825|183280906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692907|NCT00630825|183280906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692908|NCT00630825|183280906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692909|NCT00630825|183280906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
91692910|NCT00630825|183280906|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
91692911|NCT00630825|183280906|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.001
91489627|NCT01681472|182852164|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91692912|NCT00630825|183280907|SUPERIORITY_OR_OTHER|||||||0.009||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.009
91692913|NCT00630825|183280907|SUPERIORITY_OR_OTHER|||||||0.028||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.028
91692914|NCT00630825|183280907|SUPERIORITY_OR_OTHER|||||||0.047||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
91692915|NCT01011816|183280916|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX||||0.52
91692916|NCT01081769|183280919|SUPERIORITY_OR_OTHER|||||||0.0191|||||||Log Rank|||||||0.0191
91692917|NCT01081769|183280933|SUPERIORITY_OR_OTHER|||||||0.0323|||||||Fisher Exact|||||||0.0323
91692918|NCT00427648|183280938|SUPERIORITY|||||||0.588|||||||Kruskal-Wallis|||null hypothesis - no difference in average number of voids between the 2 groups, power calculation estimated 40 participants needed per arm to show a 2 void difference between lidocaine and saline placebo.||||0.588
91692919|NCT00427648|183280939|SUPERIORITY|||||||0.617|||||||Kruskal-Wallis|||||||0.617
91692920|NCT00427648|183280940|SUPERIORITY|||||||0.441|||||||Kruskal-Wallis|||||||0.441
91692921|NCT00427648|183280941|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
91489628|NCT01681472|182852164|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489629|NCT01681472|182852164|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91692922|NCT00427648|183280942|SUPERIORITY|||||||0.342|||||||Kruskal-Wallis|||||||0.342
91692923|NCT00427648|183280943|SUPERIORITY|||||||0.802|||||||Kruskal-Wallis|||||||0.802
91692924|NCT00427648|183280944|SUPERIORITY|||||||0.366|||||||Kruskal-Wallis|||||||0.366
91692925|NCT01575834|183280959|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.15|0.47||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.47|0.15|< 0.001
91692926|NCT01575834|183280960|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.39|0.15|< 0.001
91723476|NCT02516241|183340784|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9692|TWO_SIDED|95.0|0.556|1.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.759|0.556|0.9692
91723477|NCT02516241|183340792|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.1617|TWO_SIDED|95.0|-0.6|3.59||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||3.59|-0.6|0.1617
91723478|NCT02516241|183340792|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0578|TWO_SIDED|95.0|-0.07|4.29||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.29|-0.07|0.0578
91723479|NCT02516241|183340792|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.2003|TWO_SIDED|95.0|-0.91|4.32||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||4.32|-0.91|0.2003
91723480|NCT02516241|183340792|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.0178|TWO_SIDED|95.0|0.57|6.0||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||6.00|0.57|0.0178
91527927|NCT01065350|182930860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.8||||0.12|TWO_SIDED|95.0|-21.7|195.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.||195.3|-21.7|0.12
91692927|NCT01575834|183280961|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.46|0.89||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.89|0.46|0.008
91692928|NCT01575834|183280962|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.096|TWO_SIDED|95.0|0.53|1.05||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.05|0.53|0.096
91692929|NCT01575834|183280963|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.057|TWO_SIDED|95.0|0.57|0.97||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.97|0.57|0.057
91692930|NCT01575834|183280964|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.52|0.87||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.87|0.52|0.096
91692931|NCT01575834|183280965|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.44|1.02||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.02|0.44|0.096
91692932|NCT01575834|183280966|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.49|0.91||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab|||0.91|0.49|0.096
91692933|NCT01575834|183280967|SUPERIORITY||Odds Ratio (OR)|0.28||||0.096|TWO_SIDED|95.0|0.17|0.49||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.49|0.17|0.096
91692934|NCT01575834|183280968|SUPERIORITY||Odds Ratio (OR)|0.26||||0.096|TWO_SIDED|95.0|0.16|0.41||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test|Values \< 1 for odds ratio favor romosozumab.|||0.41|0.16|0.096
91692935|NCT01575834|183280969|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.18|TWO_SIDED|95.0|0.22|1.35||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.35|0.22|0.18
91692936|NCT01575834|183280970|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.12|TWO_SIDED|95.0|0.24|1.04||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.04|0.24|0.12
91489630|NCT01681472|182852165|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91692937|NCT01575834|183280971|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.012|TWO_SIDED|95.0|0.4|0.9|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.90|0.40|0.012
91692938|NCT01575834|183280972|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.002|TWO_SIDED|95.0|0.46|0.84|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.84|0.46|0.002
91692939|NCT01575834|183280973|SUPERIORITY||Odds Ratio (OR)|0.11||||0.011|TWO_SIDED|95.0|0.01|0.87|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.87|0.01|0.011
91692940|NCT01575834|183280974|SUPERIORITY||Odds Ratio (OR)|0.06|||<|0.001|TWO_SIDED|95.0|0.01|0.44|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.44|0.01|< 0.001
91692941|NCT01575834|183280975|SUPERIORITY||LS Mean Difference|12.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|12.4|12.9|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||12.9|12.4|< 0.001
91692942|NCT01575834|183280976|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|10.8|11.4|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||11.4|10.8|< 0.001
91692943|NCT01575834|183280977|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.6|6.0|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||6.0|5.6|< 0.001
91692944|NCT01575834|183280978|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.1|5.5|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.5|5.1|< 0.001
91692945|NCT01575834|183280979|SUPERIORITY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.9|5.4|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.4|4.9|< 0.001
91692946|NCT01575834|183280980|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.7|5.2|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.2|4.7|< 0.001
91692947|NCT01383174|183281009|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||0.015
91692948|NCT01383174|183281010|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.465
91692949|NCT01383174|183281011|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.025
91723481|NCT02516241|183340792|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.3765|TWO_SIDED|95.0|-1.96|5.17||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||5.17|-1.96|0.3765
91692950|NCT01383174|183281012|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.004
91692951|NCT01383174|183281013|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.013
91692952|NCT01383174|183281014|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.267
91692953|NCT01383174|183281015|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.030
91692954|NCT01383174|183281016|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.045
91527928|NCT01065350|182930861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.6||||0.017|TWO_SIDED|95.0|33.8|331.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.||331.3|33.8|0.017
91692955|NCT01383174|183281017|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.005
91723482|NCT02516241|183340792|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.03|TWO_SIDED|95.0|0.4|7.81||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||7.81|0.40|0.0300
91692956|NCT01383174|183281018|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.226
91692957|NCT01153815|183281019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Exact Smirnov test|||||||<0.001
91692958|NCT03859427|183281066|NON_INFERIORITY|The non-inferiority margin was 0.87 for the estimated ORR risk ratio.|Risk Ratio (RR)|0.954||||0.0666|TWO_SIDED|95.0|0.882|1.032||P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.|Synthesis approach||Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.032|0.882|0.0666
91692959|NCT03859427|183281068|OTHER||Odds Ratio (OR)|1.049|||||TWO_SIDED|95.0|0.653|1.683|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.683|0.653|
91692960|NCT03859427|183281074|OTHER||Odds Ratio (OR)|1.235|||||TWO_SIDED|95.0|0.775|1.97|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.970|0.775|
91692961|NCT03859427|183281075|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.657|1.711|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.711|0.657|
91692962|NCT03859427|183281076|OTHER||Least Squares (LS) Mean Difference|2.53|||||TWO_SIDED|95.0|0.38|4.69|||||Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.69|0.38|
91692963|NCT03859427|183281077|OTHER||LS Mean Difference|1.73|||||TWO_SIDED|95.0|-1.26|4.72|||||Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.72|-1.26|
91692964|NCT03859427|183281078|OTHER||LS Mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-2.54|2.03|||||Treatment difference at Cycle 5|||2.03|-2.54|
91692965|NCT03859427|183281078|OTHER||LS Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.24|2.28|||||Treatment difference at Cycle 12|||2.28|-3.24|
91692966|NCT03859427|183281078|OTHER||LS Mean difference|1.44|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-1.69|4.58|||||Treatment difference at safety follow-up|||4.58|-1.69|
91692967|NCT04031846|183281079|OTHER|Difference in % and 95 % confidence interval (CI) are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.6|||=|0.824|TWO_SIDED|95.0|-5.0|6.3|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in % : Injection site erythema||6.3|-5.0|= 0.824
91692968|NCT04031846|183281079|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|2.8|||=|0.324|TWO_SIDED|95.0|-2.8|8.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site induration||8.4|-2.8|= 0.324
91692969|NCT04031846|183281079|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|11.3|||<|0.001|TWO_SIDED|95.0|5.8|16.6|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site pain||16.6|5.8|< 0.001
91692970|NCT04031846|183281079|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.1|||=|0.128|TWO_SIDED|95.0|-1.2|9.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site swelling||9.4|-1.2|= 0.128
91692971|NCT04031846|183281080|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.4|||=|0.885|TWO_SIDED|95.0|-5.0|5.8|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Decreased appetite||5.8|-5.0|= 0.885
91692972|NCT04031846|183281080|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|5.4|||=|0.045|TWO_SIDED|95.0|0.1|10.7|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Irritability||10.7|0.1|= 0.045
91692973|NCT04031846|183281080|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.4|||=|0.131|TWO_SIDED|95.0|-1.3|10.0|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Somnolence||10.0|-1.3|= 0.131
91692974|NCT04031846|183281080|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.1|||=|0.898|TWO_SIDED|95.0|-2.4|2.1|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Urticaria||2.1|-2.4|= 0.898
91692975|NCT04031846|183281081|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.0|0.5|||||V114 minus Prevenar 13™|Difference in %||0.5|-1.0|
91527929|NCT01065350|182930861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.7||||0.17|TWO_SIDED|95.0|-58.1|315.5|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.||315.5|-58.1|0.17
91489631|NCT01681472|182852165|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91527930|NCT01065350|182930862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.029|TWO_SIDED|95.0|0.5|8.4|||t-test, 2 sided|||Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.||8.4|0.5|0.029
91692976|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.57|0.68||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 1 GMC Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.57|< 0.001
91692977|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.28|||<|0.001|TWO_SIDED|95.0|1.17|1.39||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 3 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.17|< 0.001
91692978|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.82||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 4 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.82|0.68|< 0.001
91692979|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.7||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 5 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.70|0.59|< 0.001
91692980|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.76|0.61|< 0.001
91692981|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.07||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6B GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.07|0.85|< 0.001
91692982|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.85||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 7F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.72|< 0.001
91692983|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.78||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 9V GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.66|< 0.001
91723483|NCT02516241|183340793|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.1373|TWO_SIDED|95.0|-0.6|4.36||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.36|-0.6|0.1373
91489632|NCT01681472|182852165|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91692984|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.67|0.83||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 14 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.67|< 0.001
91692985|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.95||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 18C GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.80|< 0.001
91489633|NCT01681472|182852165|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489634|NCT01681472|182852165|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
91692986|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.75|< 0.001
91692987|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.80|< 0.001
91692988|NCT04031846|183281082|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.79|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 23F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.79|< 0.001
91692989|NCT04031846|183281082|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|71.79|||<|0.001|TWO_SIDED|95.0|65.16|79.1||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 22F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||79.10|65.16|< 0.001
91692990|NCT04031846|183281082|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|46.58|||<|0.001|TWO_SIDED|95.0|42.19|51.42||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 33F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||51.42|42.19|< 0.001
91692991|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-4.7|-1.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI is based on the Miettinen \& Nurminen method.|-1.3|-4.7|< 0.001
91692992|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|8.2|||<|0.001|TWO_SIDED|95.0|4.4|12.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI is based on the Miettinen \& Nurminen method.|12.2|4.4|< 0.001
91692993|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-4.5|< 0.001
91692994|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
91692995|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.9|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI is based on the Miettinen \& Nurminen method.|1.1|-1.9|< 0.001
91692996|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-3.5|< 0.001
91692997|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI is based on the Miettinen \& Nurminen method.|0.9|-0.9|< 0.001
91489635|NCT01681472|182852165|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91692998|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.4|-0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI is based on the Miettinen \& Nurminen method.|-0.4|-2.4|< 0.001
91692999|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
91693000|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.8|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.8|< 0.001
91693001|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
91693002|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
91693003|NCT04031846|183281083|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-2.7|1.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI is based on the Miettinen \& Nurminen method.|1.5|-2.7|< 0.001
91693004|NCT04031846|183281083|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|93.8|||<|0.001|TWO_SIDED|95.0|91.5|95.6||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI is based on the Miettinen \& Nurminen method.|95.6|91.5|< 0.001
91693005|NCT04031846|183281083|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|94.9|||<|0.001|TWO_SIDED|95.0|92.7|96.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI is based on the Miettinen \& Nurminen method.|96.5|92.7|< 0.001
91693006|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-1.7|0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Diphtheria toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.4|-1.7|< 0.001
91693007|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Tetanus toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
91693008|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PT|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.3|< 0.001
91723484|NCT02516241|183340793|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.0034|TWO_SIDED|95.0|1.26|6.27||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||6.27|1.26|0.0034
91723485|NCT02516241|183340793|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.1774|TWO_SIDED|95.0|-1.0|5.39||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||5.39|-1.00|0.1774
91723486|NCT02516241|183340793|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.0011|TWO_SIDED|95.0|2.19|8.65||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||8.65|2.19|0.0011
91723487|NCT02516241|183340793|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3494|TWO_SIDED|95.0|-2.27|6.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||6.38|-2.27|0.3494
91693009|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis FHA|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
91693010|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PRN|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
91693011|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Hib PRP|95% CI is based on the Miettinen \& Nurminen method.|2.1|-1.3|< 0.001
91693012|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-2.0|0.0||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: HBsAg|95% CI is based on the Miettinen \& Nurminen method.|-0.0|-2.0|< 0.001
91693013|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 1|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
91693014|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 2|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
91693015|NCT04031846|183281084|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.5|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 3|95% CI is based on the Miettinen \& Nurminen method.|1.1|-0.5|< 0.001
91693016|NCT04031846|183281085|NON_INFERIORITY|Non-inferiority of Rotarix™ administered concomitantly with V114 to Rotarix™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMT ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.8|1.16||1-sided p-value|t-distribution||V114/Prevenar 13™|GMT Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group||1.16|0.80|< 0.001
91693017|NCT04031846|183281086|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.73|0.88|||||V114 / Prevenar 13™|GMC Ratio Serotype 1: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.88|0.73|
91693018|NCT04031846|183281086|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.7|2.02|||||V114 / Prevenar 13™|GMC Ratio Serotype 3: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.02|1.70|
91693019|NCT04031846|183281086|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||V114 / Prevenar 13™|GMC Ratio Serotype 4: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.98|
91693020|NCT04031846|183281086|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.94|||||V114 / Prevenar 13™|GMC Ratio Serotype 5: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.94|0.74|
91693021|NCT04031846|183281086|OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.4|0.52|||||V114 / Prevenar 13™|GMC Ratio Serotype 6A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.52|0.40|
91693022|NCT04031846|183281086|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.41|||||V114 / Prevenar 13™|GMC Ratio Serotype 6B: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.41|1.00|
91693023|NCT04031846|183281086|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||V114 / Prevenar 13™|GMC Ratio Serotype 7F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.76|
91693024|NCT04031846|183281086|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.96|||||V114 / Prevenar 13™|GMC Ratio Serotype 9V: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.96|0.77|
91693025|NCT04031846|183281086|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.86|||||V114 / Prevenar 13™|GMC Ratio Serotype 14: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.66|
91693026|NCT04031846|183281086|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||V114 / Prevenar 13™|GMC Ratio Serotype 18C: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.77|
91693027|NCT04031846|183281086|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.87|||||V114 / Prevenar 13™|GMC Ratio Serotype 19A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.87|0.70|
91693028|NCT04031846|183281086|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||V114 / Prevenar 13™|GMC Ratio Serotype 19F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.70|
91693029|NCT04031846|183281086|OTHER||GMC Ratio|1.22|||||TWO_SIDED|95.0|1.07|1.4|||||V114 / Prevenar 13™|GMC Ratio Serotype 23F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.40|1.07|
91693030|NCT04031846|183281086|OTHER||GMC Ratio|57.69|||||TWO_SIDED|95.0|51.2|65.0|||||V114 / Prevenar 13™|GMC Ratio Serotype 22F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||65.00|51.20|
91489636|NCT01681472|182852166|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
91489637|NCT01681472|182852166|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
91693031|NCT04031846|183281086|OTHER||GMC Ratio|6.24|||||TWO_SIDED|95.0|5.46|7.14|||||V114 / Prevenar 13™|GMC Ratio Serotype 33F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||7.14|5.46|
91723488|NCT02516241|183340793|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.0011|TWO_SIDED|95.0|2.96|11.71||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||11.71|2.96|0.0011
91723489|NCT02516241|183340794|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.3865|TWO_SIDED|95.0|-4.35|1.69||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.69|-4.35|0.3865
91723490|NCT02516241|183340794|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.284|TWO_SIDED|95.0|-5.05|1.49||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.49|-5.05|0.2840
91723491|NCT02516241|183340794|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.297|TWO_SIDED|95.0|-5.41|1.66||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.66|-5.41|0.2970
91693032|NCT04031846|183281087|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-4.4|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI are based on the Miettinen \& Nurminen method.|0.3|-4.4|
91693033|NCT04031846|183281087|OTHER||Percentage Difference|25.7|||||TWO_SIDED|95.0|21.1|30.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI are based on the Miettinen \& Nurminen method.|30.3|21.1|
91693034|NCT04031846|183281087|OTHER||Percentage Difference|-2.9|||||TWO_SIDED|95.0|-5.7|-0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI are based on the Miettinen \& Nurminen method.|-0.3|-5.7|
91693035|NCT04031846|183281087|OTHER||Percentage Difference|-3.9|||||TWO_SIDED|95.0|-8.1|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI are based on the Miettinen \& Nurminen method.|0.3|-8.1|
91693036|NCT04031846|183281087|OTHER||Percentage Difference|-19.4|||||TWO_SIDED|95.0|-23.9|-15.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI are based on the Miettinen \& Nurminen method.|-15.0|-23.9|
91693037|NCT04031846|183281087|OTHER||Percentage Difference|4.6|||||TWO_SIDED|95.0|-1.5|10.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI are based on the Miettinen \& Nurminen method.|10.7|-1.5|
91693038|NCT04031846|183281087|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-2.9|0.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI are based on the Miettinen \& Nurminen method.|0.5|-2.9|
91693039|NCT04031846|183281087|OTHER||Percentage Difference|-6.7|||||TWO_SIDED|95.0|-10.1|-3.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI are based on the Miettinen \& Nurminen method.|-3.5|-10.1|
91723492|NCT02516241|183340794|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.3026|TWO_SIDED|95.0|-5.85|1.83||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.83|-5.85|0.3026
91489638|NCT01681472|182852166|SUPERIORITY|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0166
91489639|NCT01681472|182852166|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
91693040|NCT04031846|183281087|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI are based on the Miettinen \& Nurminen method.|1.7|-2.6|
91693041|NCT04031846|183281087|OTHER||Percentage Difference|-0.7|||||TWO_SIDED|95.0|-3.9|2.6|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI are based on the Miettinen \& Nurminen method.|2.6|-3.9|
91693042|NCT04031846|183281087|OTHER||Percentage Difference|-1.2|||||TWO_SIDED|95.0|-3.5|1.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI are based on the Miettinen \& Nurminen method.|1.0|-3.5|
91693043|NCT04031846|183281087|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.0|0.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI are based on the Miettinen \& Nurminen method.|0.7|-2.0|
91693044|NCT04031846|183281087|OTHER||Percentage Difference|6.6|||||TWO_SIDED|95.0|1.3|11.9|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI are based on the Miettinen \& Nurminen method.|11.9|1.3|
91693045|NCT04031846|183281087|OTHER||Percentage Difference|90.4|||||TWO_SIDED|95.0|87.4|92.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI are based on the Miettinen \& Nurminen method.|92.7|87.4|
91527931|NCT01065350|182930862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.051|TWO_SIDED|95.0|0.0|9.7|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||9.7|-0.0|0.051
91693046|NCT04031846|183281087|OTHER||Percentage Difference|45.9|||||TWO_SIDED|95.0|41.3|50.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI are based on the Miettinen \& Nurminen method.|50.3|41.3|
91693047|NCT04031846|183281090|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.8|||||TWO_SIDED|95.0|12.9|19.2|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 22F minus Prevenar 13™ Serotype 3||19.2|12.9|
91693048|NCT04031846|183281090|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.3|||||TWO_SIDED|95.0|12.2|18.7|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 33F minus Prevenar 13™ Serotype 3||18.7|12.2|
91693049|NCT01622673|183281111|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.678|||||TWO_SIDED|90.0|0.531|0.866|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for TUMS® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.866|0.531|
91693050|NCT01622673|183281111|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.373|||||TWO_SIDED|90.0|0.293|0.475|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean C12hrs for MINTOX® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.475|0.293|
91693051|NCT01622673|183281112|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.437|||||TWO_SIDED|90.0|0.344|0.554|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® before raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.554|0.344|
91693052|NCT01622673|183281112|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.433|||||TWO_SIDED|90.0|0.341|0.55|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® after raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.550|0.341|
91693053|NCT01622673|183281113|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.445|||||TWO_SIDED|90.0|0.35|0.565|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for TUMS® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.565|0.350|
91693054|NCT01622673|183281113|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.51|||||TWO_SIDED|90.0|0.402|0.646|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.646|0.402|
91693055|NCT01622673|183281114|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.351|0.669|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® before raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.669|0.351|
91693056|NCT01622673|183281114|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.696|||||TWO_SIDED|90.0|0.504|0.96|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® after raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.960|0.504|
91693057|NCT01622673|183281115|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.476|||||TWO_SIDED|90.0|0.362|0.627|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for TUMS® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.627|0.362|
91723493|NCT02516241|183340794|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.3168|TWO_SIDED|95.0|-7.29|2.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||2.38|-7.29|0.3168
91693058|NCT01622673|183281115|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.555|||||TWO_SIDED|95.0|0.423|0.729|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean Cmax for MINTOX® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.729|0.423|
91527932|NCT01065350|182930863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.027|TWO_SIDED|95.0|0.3|4.7|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.||4.7|0.3|0.027
91693059|NCT01622673|183281116|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.332|0.709|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® before raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.709|0.332|
91693060|NCT01622673|183281116|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.775|||||TWO_SIDED|90.0|0.53|1.132|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® after raltegravir / geometric least squares mean Cmax for raltegravir alone|||1.132|0.530|
91693061|NCT04229095|183281148|SUPERIORITY||Slope|-4.58|STANDARD_ERROR_OF_MEAN|1.82||0.007|ONE_SIDED|95.0||-1.01|||Mixed Models Analysis||The effect of the drug on lowering VAS was limited to individuals with impaired sleep at baseline (PSQI \> or = to 5).|Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictors were drug condition, and baseline sleep disturbance (Pittsburgh Sleep Quality Index {PSQI} total score less than 5 or 5 and greater). Arms were combined for this analysis.||-1.01||.007
91693062|NCT04229095|183281150|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.54||0.0025|ONE_SIDED|95.0||-0.46|||Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces number of drinks per day. Principle predictors were drug condition and sex. Arms were combined for this analysis.||-0.46||.0025
91693063|NCT01780038|183281152|OTHER||||||||||||||||||Frequencies and percentages were used to determine this secondary outcome.|||
91693064|NCT02314260|183281164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.917|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.854|0.979||Under the nonparametric assumption. P-value \<0.05, means statistical significance|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.979|0.854|0.000
91693065|NCT02314260|183281165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.806|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.693|0.919||Under the nonparametric assumption P value \<0.05 is statistically significant|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.919|0.693|0.000
91693066|NCT02314260|183281166|SUPERIORITY_OR_OTHER||Slope|4.5|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
91693067|NCT02314260|183281167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
91693068|NCT01543178|183281168|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED|||||The a priori threshold for statistical significance was p \< 0.05.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel method was adjusted for analysis center and time to recurrence during Maintenance Phase 1.||A worst case analysis was performed, in which patients with \< 4 days of IBS symptom data in a given week were considered as non-responders for that week.||||0.0232
91723494|NCT02516241|183340794|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.2179|TWO_SIDED|95.0|-8.51|1.96||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||1.96|-8.51|0.2179
91723495|NCT02516241|183340795|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2419|TWO_SIDED|95.0|0.8|2.6||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patients with improvement in fatigue||2.6|0.8|0.2419
91723496|NCT02516241|183340795|SUPERIORITY||Odds Ratio (OR)|1.5||||0.1553|TWO_SIDED|95.0|0.9|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||2.8|0.9|0.1553
91527933|NCT01065350|182930863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.052|TWO_SIDED|95.0|0.0|5.2|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.||5.2|-0.0|0.052
91527934|NCT01065350|182930864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.44|TWO_SIDED|95.0|-1.4|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.||0.6|-1.4|0.44
91693069|NCT00300235|183281169|SUPERIORITY_OR_OTHER||proportion of subjects|35.2||||||95.0|32.5|37.9||||||This was a survey designed to estimate prevalence, no formal comparisons between age or genotype groups were performed.||37.9|32.5|
91693070|NCT00455403|183281177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.7279|TWO_SIDED|||||"Applies to row Title year 1"|Mixed Models Analysis||"applies to row title year 1"|||||0.7279
91693071|NCT03351608|183281186|SUPERIORITY||GM Ratio (SUG 2 mg / NEO + [GLY or ATR])|0.22|||<|0.0001|TWO_SIDED|95.0|0.16|0.32|||ANOVA|||||0.32|0.16|< 0.0001
91693072|NCT02877004|183281189|SUPERIORITY|||||||0.723|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate.||||||0.723
91693073|NCT02877004|183281190|SUPERIORITY|||||||0.368|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate||||||.368
91693074|NCT02727478|183281191|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||< 0.001
91693075|NCT02727478|183281192|SUPERIORITY||||||=|0.001|||||||ANOVA|||||||=0.001
91693076|NCT02727478|183281193|OTHER|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
91693077|NCT02727478|183281194|SUPERIORITY||||||=|0.065|||||||Wilcoxon (Mann-Whitney)|||||||=0.065
91693078|NCT02727478|183281195|SUPERIORITY||||||=|0.301|||||||ANOVA|||||||=0.301
91693079|NCT02727478|183281196|SUPERIORITY||||||=|0.792|||||||ANOVA|||||||=0.792
91693080|NCT02727478|183281197|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91693081|NCT00502242|183281201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.228||||0.0002|TWO_SIDED|95.0|0.099|0.528||2-sided p-value; alpha equals (=) 0.05|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.528|0.099|0.0002
91693082|NCT00502242|183281202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425||||0.0031|TWO_SIDED|95.0|0.237|0.763||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.763|0.237|0.0031
91693083|NCT00502242|183281203|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
91693084|NCT00502242|183281203|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.074
91693085|NCT00502242|183281204|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.093
91693086|NCT00502242|183281204|SUPERIORITY_OR_OTHER|||||||0.219|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.219
91693087|NCT00502242|183281205|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
91693088|NCT00502242|183281205|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.121
91693089|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.16|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
91693090|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.36|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
91693091|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.0098|TWO_SIDED|95.0|0.76|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 3, Ramipril versus (vs.) Placebo||0.96|0.76|0.0098
91693092|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.18|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Ramipril||||
91693093|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Placebo||||
91693094|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 4, Ramipril vs. Placebo||0.89|0.68|0.0003
91693095|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Ramipirl||||
91693096|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.61|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Placebo||||
91693097|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0016|TWO_SIDED|95.0|0.68|0.91||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.91|0.68|0.0016
91527935|NCT01065350|182930864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.37|TWO_SIDED|95.0|-1.6|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.||0.6|-1.6|0.37
91527936|NCT01373450|182930865|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.87||||0.024|TWO_SIDED|90.0|0.77|0.98|||t-test, 1 sided|||||0.98|0.77|0.024
91527937|NCT01373450|182930866|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.004|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.004
91527938|NCT01373450|182930867|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.014|||<|0.001|TWO_SIDED|90.0|0.008|0.019|||t-test, 1 sided|||||0.019|0.008|<0.001
91527939|NCT01373450|182930868|SUPERIORITY_OR_OTHER||Intraclass Correlation Coefficient|0.92|||||TWO_SIDED|90.0|0.72|0.98||||||||0.98|0.72|
91723497|NCT02516241|183340795|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0003|TWO_SIDED|95.0|1.4|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.8|1.4|0.0003
91723498|NCT02516241|183340795|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0148|TWO_SIDED|95.0|1.1|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|1.1|0.0148
91723499|NCT02516241|183340796|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2473|TWO_SIDED|95.0|0.7|3.4||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.4|0.7|0.2473
91723500|NCT02516241|183340796|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0148|TWO_SIDED|95.0|0.8|3.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.8|0.8|0.0148
91723501|NCT02516241|183340796|SUPERIORITY||Odds Ratio (OR)|1.9||||0.009|TWO_SIDED|95.0|1.2|3.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||3.0|1.2|0.0090
91489640|NCT01681472|182852166|SUPERIORITY|||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.9581
91489641|NCT01681472|182852166|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
91693098|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.34|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
91693099|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.63|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
91693100|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.82||||0.0165|TWO_SIDED|95.0|0.7|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.96|0.70|0.0165
91693101|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.48|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
91693102|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.78|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
91693103|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.83||||0.0264|TWO_SIDED|95.0|0.7|0.98||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.98|0.70|0.0264
91693104|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
91693105|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.82|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
91693106|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0062|TWO_SIDED|95.0|0.66|0.93||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||0.93|0.66|0.0062
91693107|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.4|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
91693108|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
91693109|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.0341|TWO_SIDED|95.0|0.72|0.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||0.99|0.72|0.0341
91693110|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.56|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
91693111|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.86|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
91693112|NCT00502242|183281206|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.06|TWO_SIDED|95.0|0.7|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.01|0.70|0.0600
91693113|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.46|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
91693114|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.05|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
91693115|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.71||||0.0034|TWO_SIDED|95.0|0.57|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 3, Ramipril vs. Placebo||0.89|0.57|0.0034
91693116|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Ramipril||||
91723502|NCT02516241|183340796|SUPERIORITY||Odds Ratio (OR)|1.4||||0.151|TWO_SIDED|95.0|0.9|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|0.9|0.1510
91723503|NCT02516241|183340797|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6763|TWO_SIDED|95.0|0.5|3.2||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.2|0.5|0.6763
91723504|NCT02516241|183340797|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6539|TWO_SIDED|95.0|0.5|3.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.3|0.5|0.6539
91723505|NCT02516241|183340797|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0092|TWO_SIDED|95.0|1.2|4.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||4.0|1.2|0.0092
91723506|NCT02516241|183340797|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0324|TWO_SIDED|95.0|1.1|3.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||3.5|1.1|0.0324
91723507|NCT01769586|183340812|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Chi-squared|||||.50|.24|<0.001
91723508|NCT00191100|183340813|SUPERIORITY_OR_OTHER||PFS Probability Difference at 3 Years|0.095||||0.029||95.0|0.01|0.179||The p-value is two-sided and was tested at the 0.05 significance level.|Z Statistic||Difference in progression-free survival probability between Gem/Cis/Rad and Cis/Rad. The difference in PFS probability between the two treatment arms can also be presented as a percentage (ie, PFS at 3 years was 9.5% better in the Gem/Cis/Rad arm).|||0.179|0.010|0.029
91723509|NCT00191100|183340814|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Log Rank|||||||0.0008
91723510|NCT00191100|183340815|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||"Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure."||||0.096
91527940|NCT01373450|182930869|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.003|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.003
91723511|NCT00191100|183340816|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||||||0.250
91723512|NCT00191100|183340817|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Log Rank|||||||0.0224
91723513|NCT00191100|183340818|SUPERIORITY_OR_OTHER|||||||0.0227||95.0|||||Log Rank|||||||0.0227
91723514|NCT04950686|183340819|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.983|TWO_SIDED||||||Mixed Models Analysis|||||||0.983
91723515|NCT04950686|183340819|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.465|TWO_SIDED||||||Mixed Models Analysis|||||||0.465
91527941|NCT01373450|182930869|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.45|0.74|||t-test, 1 sided|||||0.74|0.45|<0.001
91527942|NCT01373450|182930869|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99||||0.473|TWO_SIDED|90.0|0.85|1.16|||t-test, 1 sided|||||1.16|0.85|0.473
91527943|NCT01373450|182930869|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75||||0.049|TWO_SIDED|90.0|0.56|1.0|||t-test, 1 sided|||||1.00|0.56|0.049
91723516|NCT04950686|183340820|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
91723517|NCT04950686|183340820|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.536|TWO_SIDED||||||Mixed Models Analysis|||||||0.536
91723518|NCT04950686|183340821|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.745|TWO_SIDED||||||Mixed Models Analysis|||||||0.745
91723519|NCT04950686|183340821|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.14||0.972|TWO_SIDED||||||Mixed Models Analysis|||||||0.972
91527944|NCT01373450|182930870|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.021|||<|0.001|TWO_SIDED|90.0|0.015|0.026|||t-test, 1 sided|||||0.026|0.015|<0.001
91693117|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.37|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Placebo||||
91693118|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 4, Ramipril vs. Placebo||0.76|0.47|<0.0001
91693119|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Ramipril||||
91693120|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.74|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Placebo||||
91693121|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.61||||0.0002|TWO_SIDED|95.0|0.47|0.79||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.79|0.47|0.0002
91693122|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.91|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
91693123|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
91693124|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.65||||0.0032|TWO_SIDED|95.0|0.49|0.87||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.87|0.49|0.0032
91693125|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.33|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
91693126|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
91693127|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.69||||0.013|TWO_SIDED|95.0|0.51|0.92||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.92|0.51|0.0130
91693128|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.5|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
91693129|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
91489642|NCT01681472|182852167|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693130|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.74||||0.0577|TWO_SIDED|95.0|0.54|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||1.01|0.54|0.0577
91693131|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
91693132|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
91489643|NCT01681472|182852167|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693133|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.77||||0.1146|TWO_SIDED|95.0|0.56|1.07||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||1.07|0.56|0.1146
91693134|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
91693135|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.45|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
91693136|NCT00502242|183281207|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.3496|TWO_SIDED|95.0|0.6|1.2||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.20|0.60|0.3496
91723520|NCT04950686|183340822|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.12||||0.682|TWO_SIDED|95.0|0.24|5.25|||Mixed Models Analysis|||||5.25|0.24|0.682
91723521|NCT04950686|183340822|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15||||0.63|TWO_SIDED|95.0|0.28|4.69|||Mixed Models Analysis|||||4.69|0.28|0.630
91723522|NCT04950686|183340823|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.418|TWO_SIDED|95.0|0.12|12.82|||Mixed Models Analysis|||||12.82|0.12|0.418
91723523|NCT04950686|183340823|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.194|TWO_SIDED|95.0|0.13|17.29|||Mixed Models Analysis|||||17.29|0.13|0.194
91723524|NCT04950686|183340824|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.731|TWO_SIDED|95.0|0.1|8.07|||Mixed Models Analysis|||||8.07|0.10|0.731
91723525|NCT04950686|183340824|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.786|TWO_SIDED|95.0|0.16|7.34|||Mixed Models Analysis|||||7.34|0.16|0.786
91723526|NCT04950686|183340825|SUPERIORITY|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.11||||0.71|TWO_SIDED|95.0|0.16|7.49|||Mixed Models Analysis|||||7.49|0.16|0.710
91723527|NCT04950686|183340825|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.16||||0.61|TWO_SIDED|95.0|0.16|8.73|||Mixed Models Analysis|||||8.73|0.16|0.610
91723528|NCT04950686|183340826|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.37||||0.27|TWO_SIDED|95.0|0.09|20.33|||Mixed Models Analysis|||||20.33|.09|0.270
91723529|NCT04950686|183340826|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.465|TWO_SIDED|95.0|0.08|18.57|||Mixed Models Analysis|||||18.57|0.08|0.465
91723530|NCT04950686|183340827|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.702|TWO_SIDED|95.0|0.07|11.95|||Mixed Models Analysis|||||11.95|0.07|0.702
91723531|NCT04950686|183340827|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.21||||0.538|TWO_SIDED|95.0|0.19|7.56|||Mixed Models Analysis|||||7.56|0.19|0.538
91723532|NCT04950686|183340828|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.084|TWO_SIDED||||||Mixed Models Analysis|||||||0.084
91723533|NCT04950686|183340828|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
91723534|NCT04950686|183340829|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.614|TWO_SIDED||||||Mixed Models Analysis|||||||0.614
91723535|NCT04950686|183340829|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.854|TWO_SIDED||||||Mixed Models Analysis|||||||0.854
91723536|NCT04950686|183340830|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.499|TWO_SIDED||||||Mixed Models Analysis|||||||0.499
91723537|NCT04950686|183340830|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.623|TWO_SIDED||||||Mixed Models Analysis|||||||0.623
91723538|NCT04950686|183340831|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.84||||0.618|TWO_SIDED|95.0|0.14|5.15|||Mixed Models Analysis|||||5.15|0.14|0.618
91723539|NCT04950686|183340831|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.19||||0.626|TWO_SIDED|95.0|0.1|14.13|||Mixed Models Analysis|||||14.13|0.10|0.626
91723540|NCT04950686|183340832|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.232|TWO_SIDED|95.0|0.23|9.18|||Mixed Models Analysis|||||9.18|0.23|.232
91723541|NCT04950686|183340832|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.811|TWO_SIDED|95.0|0.22|5.38|||Mixed Models Analysis|||||5.38|0.22|0.811
91723542|NCT04950686|183340833|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.427|TWO_SIDED|95.0|0.16|9.94|||Mixed Models Analysis|||||9.94|0.16|0.427
91723543|NCT04950686|183340833|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.39||||0.337|TWO_SIDED|95.0|0.25|7.68|||Mixed Models Analysis|||||7.68|0.25|0.337
91723544|NCT04950686|183340834|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.11||0.419|TWO_SIDED||||||Mixed Models Analysis|||||||0.419
91723545|NCT04950686|183340834|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.808|TWO_SIDED||||||Mixed Models Analysis|||||||0.808
91723546|NCT04950686|183340835|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.12||0.616|TWO_SIDED||||||Mixed Models Analysis|||||||0.616
91489644|NCT01681472|182852167|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489645|NCT01681472|182852167|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693137|NCT00502242|183281208|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||1.0000
91693138|NCT00502242|183281208|SUPERIORITY_OR_OTHER|||||||0.1115|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.1115
91693139|NCT00502242|183281209|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.26||0.4933|TWO_SIDED|95.0|-3.33|1.61||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 12||1.61|-3.33|0.4933
91693140|NCT00502242|183281209|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|1.45||0.0888|TWO_SIDED|95.0|-0.38|5.33||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 24||5.33|-0.38|0.0888
91693141|NCT00502242|183281209|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.12|STANDARD_ERROR_OF_MEAN|1.46||0.1475|TWO_SIDED|95.0|-0.75|4.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate|Adjusted for baseline|Change from Baseline at Week 52||4.99|-0.75|0.1475
91693142|NCT00502242|183281210|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.1167|TWO_SIDED|95.0|0.68|1.04||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 24||1.04|0.68|0.1167
91693143|NCT00502242|183281210|SUPERIORITY_OR_OTHER||Treatment Ratio|1.04||||0.7519|TWO_SIDED|95.0|0.82|1.31||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 52||1.31|0.82|0.7519
91693144|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low DBP ≤50 mmHg||||0.470
91693145|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High DBP ≥110 mmHg||||0.220
91693146|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low SBP: ≤90 mmHg||||0.470
91693147|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High SBP: ≥180 mmHg||||1.000
91693148|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low DBP ≤50 mmHg||||0.725
91693149|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High DBP ≥110 mmHg||||0.227
91723547|NCT04950686|183340835|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.12||0.486|TWO_SIDED||||||Mixed Models Analysis|||||||0.486
91723548|NCT04950686|183340836|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
91723549|NCT04950686|183340836|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.226|TWO_SIDED||||||Mixed Models Analysis|||||||0.226
91693150|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low SBP: ≤90 mmHg||||1.000
91693151|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High SBP: ≥180 mmHg||||0.106
91693152|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, High DBP ≥110 mmHg||||1.000
91693153|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, Low SBP: ≤90 mmHg||||1.000
91489646|NCT01681472|182852167|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693154|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low DBP ≤50 mmHg||||0.475
91693155|NCT00502242|183281211|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low SBP: ≤90 mmHg||||0.475
91693156|NCT00502242|183281213|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||1.000
91693157|NCT00502242|183281213|SUPERIORITY_OR_OTHER|||||||0.626|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.626
91693158|NCT00502242|183281213|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.297
91693159|NCT00502242|183281213|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.356
91693160|NCT00502242|183281214|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.064
91693161|NCT00502242|183281214|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.069
91693162|NCT00502242|183281214|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.752
91693163|NCT00502242|183281214|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.261
91693164|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.381|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 4||||0.381
91693165|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.956|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 12||||0.956
91693166|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.903|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 24||||0.903
91693167|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.503|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 52||||0.503
91693168|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.451|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 4||||0.451
91693169|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.919|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 12||||0.919
91693170|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.637|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 24||||0.637
91693171|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.229|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 52||||0.229
91693172|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.766|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 4||||0.766
91693173|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 12||||0.217
91693174|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.457|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 24||||0.457
91723550|NCT04950686|183340837|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.630
91723551|NCT04950686|183340837|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.880
91693175|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.26|STANDARD_ERROR_OF_MEAN|0.13||0.041|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 52||||0.041
91693176|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.044|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 4||||0.044
91693177|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.18|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 12||||0.180
91693178|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.264|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 24||||0.264
91693179|NCT00502242|183281215|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.408|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 52||||0.408
91693180|NCT00502242|183281216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.487||||0.0732|TWO_SIDED|95.0|0.887|6.978||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||6.978|0.887|0.0732
91693181|NCT00502242|183281218|SUPERIORITY_OR_OTHER|||||||0.7165|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL, AM BCAR||||0.7165
91693182|NCT00502242|183281218|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL (On-Therapy), AM BCAR||||0.4795
91693183|NCT00502242|183281219|SUPERIORITY_OR_OTHER|||||||0.4773|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Week 52||||0.4773
91693184|NCT00502242|183281220|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.124
91693185|NCT00502242|183281220|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.410
91723552|NCT04950686|183340838|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
91723553|NCT04950686|183340838|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.12||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.980
91723554|NCT04950686|183340839|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
91723555|NCT04950686|183340839|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.13||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.990
91723556|NCT04950686|183340840|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.14||0.989|TWO_SIDED||||||Mixed Models Analysis|||||||0.989
91723557|NCT04950686|183340840|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.678|TWO_SIDED||||||Mixed Models Analysis|||||||0.678
91723558|NCT04950686|183340841|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
91489647|NCT01681472|182852167|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91489648|NCT01681472|182852168|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91723559|NCT04950686|183340841|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.15||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||0.024
91723560|NCT04950686|183340842|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.301|TWO_SIDED||||||Mixed Models Analysis|||||||0.301
91723561|NCT04950686|183340842|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.17||0.702|TWO_SIDED||||||Mixed Models Analysis|||||||0.702
91723562|NCT04950686|183340843|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.76||||0.352|TWO_SIDED|95.0|0.1|6.13|||Mixed Models Analysis|||||6.13|0.10|0.352
91723563|NCT04950686|183340843|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.82||||0.445|TWO_SIDED|95.0|0.11|6.16|||Mixed Models Analysis|||||6.16|0.11|0.445
91723564|NCT04950686|183340844|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.55||||0.039|TWO_SIDED|95.0|0.12|2.6|||Mixed Models Analysis|||||2.60|0.12|0.039
91723565|NCT04950686|183340844|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.59||||0.073|TWO_SIDED|95.0|0.17|2.12|||Mixed Models Analysis|||||2.12|0.17|0.073
91723566|NCT04950686|183340845|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.13|2.93|||Mixed Models Analysis|||||2.93|0.13|0.110
91723567|NCT04950686|183340845|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.65||||0.174|TWO_SIDED|95.0|0.11|3.78|||Mixed Models Analysis|||||3.78|0.11|0.174
91723568|NCT04950686|183340846|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.31||0.208|TWO_SIDED||||||Mixed Models Analysis|||||||0.208
91723569|NCT04950686|183340846|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.302|TWO_SIDED||||||Mixed Models Analysis|||||||0.302
91723570|NCT04950686|183340847|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.483|TWO_SIDED||||||Mixed Models Analysis|||||||0.483
91489649|NCT01681472|182852168|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489650|NCT01681472|182852168|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0022
91723571|NCT04950686|183340847|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.3||0.933|TWO_SIDED||||||Mixed Models Analysis|||||||0.933
91489651|NCT01681472|182852168|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489652|NCT01681472|182852168|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91527945|NCT01373450|182930870|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.03|||<|0.001|TWO_SIDED|90.0|0.021|0.038|||t-test, 1 sided|||||0.038|0.021|<0.001
91723572|NCT04950686|183340848|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.32||0.877|TWO_SIDED||||||Mixed Models Analysis|||||||0.877
91723573|NCT04950686|183340848|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.32||0.418|TWO_SIDED||||||Mixed Models Analysis|||||||0.418
91723574|NCT04950686|183340849|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|2.23||||0.22|TWO_SIDED|95.0|0.05|98.76|||Mixed Models Analysis|||||98.76|0.05|0.220
91723575|NCT04950686|183340849|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.1|11.3||||||||11.30|0.10|
91723576|NCT04950686|183340850|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.48||||0.506|TWO_SIDED|95.0|0.03|63.29|||Mixed Models Analysis|||||63.29|0.03|0.506
91723577|NCT04950686|183340850|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.04|36.32||||||||36.32|0.04|
91723578|NCT04950686|183340851|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.09||||0.877|TWO_SIDED|95.0|0.04|28.37|||Mixed Models Analysis|||||28.37|0.04|0.877
91723579|NCT04950686|183340851|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.02|26.92||||||||26.92|0.02|
91723580|NCT04950686|183340852|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.005|TWO_SIDED||||||Mixed Models Analysis|||||||0.005
91723581|NCT04950686|183340852|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.05||1e-05|TWO_SIDED||||||Mixed Models Analysis|||||||0.00001
91527946|NCT01373450|182930870|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.007||||0.0163|TWO_SIDED|90.0|0.002|0.012|||t-test, 1 sided|||||0.012|0.002|0.0163
91527947|NCT01373450|182930870|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.016||||0.0056|TWO_SIDED|90.0|0.006|0.026|||t-test, 1 sided|||||0.026|0.006|0.0056
91723582|NCT04950686|183340853|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.314|TWO_SIDED||||||Mixed Models Analysis|||||||0.314
91527948|NCT00550550|182930872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|||=|0.001|TWO_SIDED|95.0|-2.6|-0.66|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.66|-2.60|=0.001
91527949|NCT00550550|182930873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.005|TWO_SIDED|95.0|-1.95|-0.45|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.45|-1.95|=0.005
91527950|NCT00550550|182930874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||=|0.066|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.03|-0.88|=0.066
91723583|NCT04950686|183340853|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.176|TWO_SIDED||||||Mixed Models Analysis|||||||0.176
91723584|NCT04950686|183340854|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
91723585|NCT04950686|183340854|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
91723586|NCT04950686|183340855|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.132|TWO_SIDED||||||Mixed Models Analysis|||||||0.132
91489653|NCT01681472|182852168|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91527951|NCT00550550|182930875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||=|0.042|TWO_SIDED|95.0|-0.6|-0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.03|-0.60|=0.042
91693186|NCT00502242|183281220|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.423
91693187|NCT00502242|183281220|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.297
91693188|NCT00502242|183281221|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.726
91723587|NCT04950686|183340855|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
91723588|NCT04950686|183340856|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.941|TWO_SIDED||||||Mixed Models Analysis|||||||0.941
91489654|NCT01681472|182852169|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91527952|NCT02459093|182930892|SUPERIORITY||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.37|0.99|||Chi-squared|||||0.99|0.37|0.04
91527953|NCT02459093|182930893|SUPERIORITY||Risk Ratio (RR)|0.6||||0.05|TWO_SIDED|95.0|0.36|1.01|||Chi-squared|||||1.01|0.36|0.05
91693189|NCT00502242|183281222|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||1.000
91693190|NCT00502242|183281223|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.753
91693191|NCT00502242|183281224|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.224
91693192|NCT00502242|183281224|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.179
91693193|NCT00502242|183281224|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.604
91693194|NCT00502242|183281224|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.486
91693195|NCT04630002|183281312|OTHER||Ratio of geometric least square means|1.137|||||TWO_SIDED|90.0|0.999|1.293|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.293|0.9990|
91693196|NCT04630002|183281313|OTHER||Ratio of geometric least square means|1.068|||||TWO_SIDED|90.0|0.9185|1.242|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.242|0.9185|
91693197|NCT04630002|183281314|OTHER||Ratio of geometric least square means|0.9891|||||TWO_SIDED|90.0|0.9313|1.051|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.051|0.9313|
91693198|NCT04630002|183281315|OTHER||Ratio of geometric least square means|1.05|||||TWO_SIDED|90.0|0.9816|1.122|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.122|0.9816|
91693199|NCT04630002|183281316|OTHER||Ratio of geometric least square means|1.102|||||TWO_SIDED|90.0|1.025|1.185|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.185|1.025|
91693200|NCT04630002|183281317|OTHER||Ratio of geometric least square means|1.12|||||TWO_SIDED|90.0|0.9947|1.26|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.260|0.9947|
91693201|NCT04630002|183281318|OTHER||Ratio of geometric least square means|0.5299|||||TWO_SIDED|90.0|0.4801|0.5848|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||0.5848|0.4801|
91693202|NCT04630002|183281319|OTHER||Ratio of geometric least square means|0.6001|||||TWO_SIDED|90.0|0.5271|0.6833|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||0.6833|0.5271|
91693203|NCT04630002|183281320|OTHER||Ratio of geometric least square means|1.144|||||TWO_SIDED|90.0|1.082|1.21|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.210|1.082|
91693204|NCT04630002|183281321|OTHER||Ratio of geometric least square means|1.104|||||TWO_SIDED|90.0|1.026|1.187|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.187|1.026|
91693205|NCT04630002|183281322|OTHER||Ratio of geometric least square means|0.9435|||||TWO_SIDED|90.0|0.8147|1.093|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.093|0.8147|
91723589|NCT04950686|183340856|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
91723590|NCT04950686|183340857|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.354|TWO_SIDED||||||Mixed Models Analysis|||||||0.354
91723591|NCT04950686|183340857|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED||||||Mixed Models Analysis|||||||0.038
91693206|NCT04630002|183281323|OTHER||Ratio of geometric least square means|0.8928|||||TWO_SIDED|90.0|0.7467|1.068|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.068|0.7467|
91693207|NCT00442897|183281371|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.714||||||95.0|1.77|7.78|||||Odds ratio was adjusted by baseline LDL strata.|||7.78|1.77|
91693208|NCT00442897|183281372|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.579||||||95.0|1.32|5.06|||||Odds ratio was adjusted by baseline LDL strata.|||5.06|1.32|
91693209|NCT04498182|183281373|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
91693210|NCT04498182|183281373|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
91693211|NCT04498182|183281374|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
91693212|NCT04498182|183281374|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
91693213|NCT04498182|183281375|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
91693214|NCT04498182|183281375|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
91693215|NCT04498182|183281376|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
91693216|NCT04498182|183281376|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
91693217|NCT04498182|183281377|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
91693218|NCT04498182|183281377|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
91693219|NCT04498182|183281378|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
91693220|NCT04498182|183281378|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
91693221|NCT04498182|183281379|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
91693222|NCT04498182|183281379|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
91723592|NCT04950686|183340858|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
91723593|NCT04950686|183340858|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.385|TWO_SIDED||||||Mixed Models Analysis|||||||0.385
91723594|NCT04950686|183340859|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.095|TWO_SIDED||||||Mixed Models Analysis|||||||0.095
91723595|NCT04950686|183340859|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.349|TWO_SIDED||||||Mixed Models Analysis|||||||0.349
91723596|NCT04950686|183340860|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
91693223|NCT04498182|183281380|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
91693224|NCT04498182|183281380|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
91693225|NCT04498182|183281381|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
91693226|NCT04498182|183281381|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
91693227|NCT04498182|183281382|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
91693228|NCT04498182|183281382|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
91693229|NCT04498182|183281383|SUPERIORITY||LS Means Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
91693230|NCT04498182|183281383|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
91693231|NCT04498182|183281384|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
91693232|NCT04498182|183281384|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
91693233|NCT04498182|183281385|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
91723597|NCT04950686|183340860|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.103|TWO_SIDED||||||Mixed Models Analysis|||||||0.103
91693234|NCT04498182|183281385|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
91693235|NCT04498182|183281386|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
91693236|NCT04498182|183281386|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
91693237|NCT04498182|183281387|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
91693238|NCT04498182|183281387|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
91693239|NCT04498182|183281388|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
91693240|NCT04498182|183281388|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
91693241|NCT04498182|183281389|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
91693242|NCT04498182|183281389|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
91693243|NCT04498182|183281390|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
91693244|NCT04498182|183281390|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
91693245|NCT04498182|183281391|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
91693246|NCT04498182|183281391|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
91693247|NCT04498182|183281392|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
91693248|NCT04498182|183281392|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
91693249|NCT04498182|183281393|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
91693250|NCT04498182|183281393|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
91693251|NCT04498182|183281394|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
91693252|NCT04498182|183281394|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
91693253|NCT04498182|183281395|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
91693254|NCT04498182|183281395|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
91693255|NCT04498182|183281396|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
91693256|NCT04498182|183281396|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
91693257|NCT04498182|183281397|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
91693258|NCT04498182|183281397|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
91693259|NCT04498182|183281398|SUPERIORITY|||||||0.3365|||||||Wilcoxon (Mann-Whitney)|||||||0.3365
91693260|NCT04498182|183281398|SUPERIORITY|||||||0.7323|||||||Wilcoxon (Mann-Whitney)|||||||0.7323
91723598|NCT04950686|183340861|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
91723599|NCT04950686|183340861|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.054|TWO_SIDED||||||Mixed Models Analysis|||||||0.054
91693261|NCT04498182|183281399|SUPERIORITY|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||||||0.1557
91693262|NCT04498182|183281399|SUPERIORITY|||||||0.6845|||||||Wilcoxon (Mann-Whitney)|||||||0.6845
91693263|NCT04498182|183281400|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
91693264|NCT04498182|183281400|SUPERIORITY|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
91693265|NCT04498182|183281401|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
91693266|NCT04498182|183281401|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
91693267|NCT04498182|183281402|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
91693268|NCT04498182|183281402|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
91693269|NCT04498182|183281403|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
91723600|NCT04950686|183340862|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
91723601|NCT04950686|183340862|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
91723602|NCT04950686|183340863|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.819|TWO_SIDED||||||Mixed Models Analysis|||||||0.819
91723603|NCT04950686|183340863|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.775|TWO_SIDED||||||Mixed Models Analysis|||||||0.775
91723604|NCT04950686|183340864|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
91723605|NCT04950686|183340864|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
91723606|NCT04950686|183340865|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.485|TWO_SIDED||||||Mixed Models Analysis|||||||0.485
91723607|NCT04950686|183340865|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
91723608|NCT04950686|183340866|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.583|TWO_SIDED||||||Mixed Models Analysis|||||||0.583
91723609|NCT04950686|183340866|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.971|TWO_SIDED||||||Mixed Models Analysis|||||||0.971
91723610|NCT04950686|183340867|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.602|TWO_SIDED||||||Mixed Models Analysis|||||||0.602
91723611|NCT04950686|183340867|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.04||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
91693270|NCT04498182|183281403|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
91693271|NCT04498182|183281404|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
91693272|NCT04498182|183281404|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
91693273|NCT04498182|183281405|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
91693274|NCT04498182|183281405|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
91693275|NCT04498182|183281406|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
91693276|NCT04498182|183281406|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
91693277|NCT04498182|183281407|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3068|TWO_SIDED|95.0|0.7|3.15|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.15|0.70|0.3068
91693278|NCT04498182|183281407|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6167|TWO_SIDED|95.0|0.56|2.68|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.68|0.56|0.6167
91693279|NCT04498182|183281408|SUPERIORITY||Odds Ratio (OR)|0.64||||0.2867|TWO_SIDED|95.0|0.28|1.46|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.46|0.28|0.2867
91693280|NCT04498182|183281408|SUPERIORITY||Odds Ratio (OR)|0.7||||0.3803|TWO_SIDED|95.0|0.32|1.57|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.57|0.32|0.3803
91693281|NCT04498182|183281409|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4375|TWO_SIDED|95.0|0.58|3.58|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.58|0.58|0.4375
91693282|NCT04498182|183281409|SUPERIORITY||Odds Ratio (OR)|1.3||||0.584|TWO_SIDED|95.0|0.51|3.27|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.27|0.51|0.5840
91693283|NCT04498182|183281410|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5046|TWO_SIDED|95.0|0.29|1.84|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.84|0.29|0.5046
91693284|NCT04498182|183281410|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5751|TWO_SIDED|95.0|0.56|2.88|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.88|0.56|0.5751
91693285|NCT01339260|183281424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.001|TWO_SIDED|95.0|1.16|1.87||If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050|Cochran-Mantel-Haenszel||Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.|The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.||1.87|1.16|0.001
91723612|NCT04950686|183340868|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.763|TWO_SIDED||||||Mixed Models Analysis|||||||0.763
91723613|NCT04950686|183340868|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.578|TWO_SIDED||||||Mixed Models Analysis|||||||0.578
91723614|NCT04950686|183340869|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
91723615|NCT04950686|183340869|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.538|TWO_SIDED||||||Mixed Models Analysis|||||||0.538
91723616|NCT04950686|183340870|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.41||0.662|TWO_SIDED||||||Mixed Models Analysis|||||||0.662
91723617|NCT04950686|183340870|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|1.81||0.406|TWO_SIDED||||||Mixed Models Analysis|||||||0.406
91723618|NCT04950686|183340871|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|1.64||0.105|TWO_SIDED||||||Mixed Models Analysis|||||||0.105
91723619|NCT04950686|183340871|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|1.91||0.487|TWO_SIDED||||||Mixed Models Analysis|||||||0.487
91723620|NCT04950686|183340872|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.68||0.171|TWO_SIDED||||||Mixed Models Analysis|||||||0.171
91723621|NCT04950686|183340872|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.06|STANDARD_ERROR_OF_MEAN|1.9||0.278|TWO_SIDED||||||Mixed Models Analysis|||||||0.278
91723622|NCT04950686|183340873|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.283|TWO_SIDED||||||Mixed Models Analysis|||||||0.283
91723623|NCT04950686|183340873|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
91723624|NCT04950686|183340874|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.965|TWO_SIDED||||||Mixed Models Analysis|||||||0.965
91723625|NCT04950686|183340874|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
91693286|NCT01339260|183281425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.047|TWO_SIDED|95.0|1.0|1.87||If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.87|1.0|0.047
91693287|NCT01339260|183281426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.001|TWO_SIDED|95.0|1.17|1.85||If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.85|1.17|0.001
91693288|NCT03137160|183281427|SUPERIORITY|||||||1|||||||Fisher Exact|||This is the Investigator Global Assessment comparing the proportion of subjects who achieved a 2 pt reduction at study close (0).||||1
91693289|NCT00558467|183281442|SUPERIORITY_OR_OTHER||Least Squares mean difference|0.01||||0.996|TWO_SIDED|95.0|-4.95|4.97|||ANCOVA|||||4.97|-4.95|0.996
91693290|NCT00558467|183281443|SUPERIORITY_OR_OTHER||Least square means difference|-3.94|||||TWO_SIDED|95.0|-5.81|-2.08|||Repeated Measures|||||-2.08|-5.81|
91693291|NCT00558467|183281444|SUPERIORITY_OR_OTHER||Least square means difference|-5.3|||||TWO_SIDED|95.0|-7.21|-3.39|||Repeated measures|||||-3.39|-7.21|
91693292|NCT00558467|183281446|SUPERIORITY_OR_OTHER||Least square means difference|-5.97|||||TWO_SIDED|95.0|-7.88|-4.06|||Repeated measures|||||-4.06|-7.88|
91693293|NCT00558467|183281447|SUPERIORITY_OR_OTHER||Least Squares Mean differnce|-0.15||||0.978|TWO_SIDED|95.0|-11.05|10.75|||ANCOVA|||||10.75|-11.05|0.9780
91693294|NCT00558467|183281452|SUPERIORITY_OR_OTHER|||||||0.1052|||||||Cochran-Mantel-Haenszel|||||||0.1052
91693295|NCT00558467|183281453|SUPERIORITY_OR_OTHER|||||||0.2274|||||||Cochran-Mantel-Haenszel|||||||0.2274
91693296|NCT00558467|183281454|SUPERIORITY_OR_OTHER|||||||0.7691|||||||Cochran-Mantel-Haenszel|||||||0.7691
91693297|NCT00558467|183281455|SUPERIORITY_OR_OTHER|||||||0.0674|||||||Cochran-Mantel-Haenszel|||||||0.0674
91693298|NCT00558467|183281456|SUPERIORITY_OR_OTHER|||||||0.4944|||||||Cochran-Mantel-Haenszel|||||||0.4944
91693299|NCT00558467|183281457|SUPERIORITY_OR_OTHER|||||||0.162|||||||Cochran-Mantel-Haenszel|||||||0.162
91693300|NCT00558467|183281458|SUPERIORITY_OR_OTHER|||||||0.6375|||||||Cochran-Mantel-Haenszel|||||||0.6375
91693301|NCT00558467|183281459|SUPERIORITY_OR_OTHER|||||||0.6625|||||||Cochran-Mantel-Haenszel|||||||0.6625
91693302|NCT00558467|183281460|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Cochran-Mantel-Haenszel|||||||0.2664
91693303|NCT00558467|183281461|SUPERIORITY_OR_OTHER|||||||0.7302|||||||Cochran-Mantel-Haenszel|||||||0.7302
91693304|NCT00558467|183281462|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
91693305|NCT00558467|183281463|SUPERIORITY_OR_OTHER|||||||0.4852|||||||Cochran-Mantel-Haenszel|||||||0.4852
91693306|NCT00558467|183281464|SUPERIORITY_OR_OTHER|||||||0.4607|||||||Cochran-Mantel-Haenszel|||||||0.4607
91693307|NCT00558467|183281465|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
91693308|NCT00558467|183281466|SUPERIORITY_OR_OTHER|||||||0.9389|||||||Cochran-Mantel-Haenszel|||||||0.9389
91693309|NCT02019264|183281477|NON_INFERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than 1.4 (the non-inferiority margin).|Hazard Ratio (HR)|1.005||||0.0001|TWO_SIDED|97.5|0.842|1.198|||Primary Analytic Method|||||1.198|0.842|0.0001
91693310|NCT02019264|183281478|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.969||||0.5464|TWO_SIDED|95.0|0.873|1.074|||Primary Analytic Method|||||1.074|0.873|0.5464
91693311|NCT02019264|183281479|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment as covariate.|Hazard Ratio (HR)|0.807||||0.038|TWO_SIDED|95.0|0.659|0.988|||Primary Analytic Method|||||0.988|0.659|0.0380
91693312|NCT02019264|183281480|NON_INFERIORITY|Myocardial Infarction: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|0.991||||0.0001|TWO_SIDED|97.5|0.824|1.191|||Primary Analytic Method|||||1.191|0.824|0.0001
91693313|NCT02019264|183281480|NON_INFERIORITY|Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% CI refers to the upper limit of the displayed 2-sided 95% CI.|Hazard Ratio (HR)|0.856||||0.0005|TWO_SIDED|97.5|0.639|1.145|||Primary Analytic Method|||||1.145|0.639|0.0005
91693314|NCT02019264|183281480|NON_INFERIORITY|Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|1.045||||0.0262|TWO_SIDED|97.5|0.778|1.404|||Primary Analytic Method|||||1.404|0.778|0.0262
91693315|NCT02019264|183281480|SUPERIORITY|Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.163||||0.3243|TWO_SIDED|95.0|0.861|1.571|||Primary Analytic Method|||||1.571|0.861|0.3243
91693316|NCT02019264|183281480|SUPERIORITY|Heart Failure: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.952||||0.6758|TWO_SIDED|95.0|0.757|1.197|||Primary Analytic Method|||||1.197|0.757|0.6758
91693317|NCT02019264|183281480|SUPERIORITY|Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.981||||0.7817|TWO_SIDED|95.0|0.856|1.125|||Primary Analytic Method|||||1.125|0.856|0.7817
91693318|NCT02019264|183281481|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.082||||0.4212|TWO_SIDED|95.0|0.893|1.31|||Primary Analytic Method|||||1.310|0.893|0.4212
91693319|NCT02019264|183281482|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|1.124||||0.181|TWO_SIDED|95.0|0.947|1.333|||Primary Analytic Method|||||1.333|0.947|0.1810
91693320|NCT02019264|183281483|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.773||||0.0116|TWO_SIDED|95.0|0.633|0.944|||Primary Analytic Method|||||0.944|0.633|0.0116
91693321|NCT02019264|183281484|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.35||P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.|ANCOVA|||||-0.35|-0.43|<0.0001
91693322|NCT02019264|183281485|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.869||||0.0054|TWO_SIDED|95.0|0.787|0.959|||Primary Analytic Method|||||0.959|0.787|0.0054
91693323|NCT02019264|183281486|SUPERIORITY|Hazard ratio on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.904||||0.3661|TWO_SIDED|95.0|0.727|1.125|||Primary Analytic Method|||||1.125|0.727|0.3661
91693324|NCT02019264|183281487|SUPERIORITY||Hazard Ratio (HR)|0.855||||0.0082|TWO_SIDED|95.0|0.762|0.96|||Primary Analytic Method|||||0.960|0.762|0.0082
91693325|NCT02019264|183281488|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.182||||0.0297|TWO_SIDED|95.0|1.017|1.375|||Primary Analytic Method|||||1.375|1.017|0.0297
91723626|NCT04950686|183340875|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.074
91723627|NCT04950686|183340875|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.828|TWO_SIDED||||||Mixed Models Analysis|||||||0.828
91723628|NCT04950686|183340876|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25||0.336|TWO_SIDED||||||Mixed Models Analysis|||||||0.336
91723629|NCT04950686|183340876|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
91693326|NCT02019264|183281489|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5015|TWO_SIDED|95.0|0.69|2.11||P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.|Regression, Logistic|||||2.11|0.69|0.5015
91693327|NCT02019264|183281490|SUPERIORITY||Odds Ratio (OR)|1.31||||0.7249|TWO_SIDED|95.0|0.29|5.98||P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.|Regression, Logistic|||||5.98|0.29|0.7249
91693328|NCT02019264|183281491|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.9036||||0.2976|TWO_SIDED|95.0|-1.2908|-0.5163||P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.|Mixed-effects model|||||-0.5163|-1.2908|0.2976
91693329|NCT03858998|183281559|SUPERIORITY||Risk Difference (RD)|0.004||||0.91|TWO_SIDED|95.0|-0.06|0.07|||Chi-squared||Direction = Linkage minus SOC|||0.07|-0.06|0.91
91693330|NCT02220764|183281573|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.||||0.03
91693331|NCT04205643|183281575|SUPERIORITY||Difference estimated using CMH weights|21.1|||<|0.0001|TWO_SIDED|95.0|11.8|29.3||If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.|Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.|The 95% stratified Newcombe CI with CMH weights|||29.3|11.8|<0.0001
91693332|NCT01804946|183281609|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0||||0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||0.05
91693333|NCT01804946|183281610|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||<0.05
91693334|NCT01804946|183281611|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2 of Oseltamivir effect|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
91693335|NCT01804946|183281612|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2°C|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.||PP set was analyzed||||<0.05
91693336|NCT01804946|183281613|NON_INFERIORITY_OR_EQUIVALENCE|The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
91693337|NCT01804946|183281614|NON_INFERIORITY_OR_EQUIVALENCE|To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
91693338|NCT01804946|183281615|NON_INFERIORITY_OR_EQUIVALENCE|To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
91693339|NCT01804946|183281616|NON_INFERIORITY_OR_EQUIVALENCE|To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|18.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
91693340|NCT01804946|183281617|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0|||||The Wald method of Z statistics calcul|The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions||PP set was analyzed||||<0.05
91693341|NCT04390113|183281652|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6253|TWO_SIDED|95.0|0.55|1.55|||Log Rank|||||1.55|0.55|0.6253
91723630|NCT04950686|183340877|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.629|TWO_SIDED||||||Mixed Models Analysis|||||||0.629
91723631|NCT04950686|183340877|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.29||0.318|TWO_SIDED||||||Mixed Models Analysis|||||||0.318
91723632|NCT04950686|183340878|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
91723633|NCT04950686|183340878|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.299|TWO_SIDED||||||Mixed Models Analysis|||||||0.299
91489655|NCT01681472|182852169|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489656|NCT01681472|182852169|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489657|NCT01681472|182852169|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91527954|NCT01103960|182930897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1881|STANDARD_ERROR_OF_MEAN|0.803||0.007||95.0|0.6082|3.7681||This was the first step in the closed testing procedure of multiple endpoints. The p-value was \<0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.|ANCOVA|||A5 minus T80/A5||3.7681|0.6082|0.007
91693342|NCT01611883|183281659|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe treatment group will be considered non-inferior to the placebo control group if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference (ezetimibe minus placebo) in means for change in HbA1c from baseline to the end of treatment does not exceed 0.5%.|Difference in Least-squares Means|0.08|||||TWO_SIDED|95.0|-0.07|0.23|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||0.23|-0.07|
91693343|NCT01611883|183281660|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|95.0|-0.47|0.47|||Longitudinal analysis of covariance||ezetimibe minus placebo|||0.47|-0.47|
91693344|NCT01611883|183281661|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-4.8|||||TWO_SIDED|95.0|-12.1|2.5|||Longitudinal Analysis of Covariance||ezetimibe minus placebo|||2.5|-12.1|
91693345|NCT01611883|183281662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.779
91693346|NCT01611883|183281663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.365
91693347|NCT01611883|183281664|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-21.05|||<|0.001|TWO_SIDED|95.0|-25.06|-17.03|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-17.03|-25.06|<0.001
91693348|NCT01611883|183281665|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.54|||<|0.001|TWO_SIDED|95.0|-16.66|-10.42|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-10.42|-16.66|<0.001
91693349|NCT01611883|183281666|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.36||||0.025|TWO_SIDED|95.0|-21.27|-1.44|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-1.44|-21.27|0.025
91693350|NCT01611883|183281667|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|2.45||||0.246|TWO_SIDED|95.0|-1.71|6.61|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||6.61|-1.71|0.246
91693351|NCT01611883|183281668|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-19.07|||<|0.001|TWO_SIDED|95.0|-22.71|-15.43|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-15.43|-22.71|<0.001
91693352|NCT00030901|183281678|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is adjusted for stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.|Regression, Logistic|||With target sample size of 466 randomized patients (233 per arm), there is a 90% of power to detect a one-third reduction in the three-year incidence rate of prostate cancer. The alpha level is set at 0.025, one-sided.||||0.73
91723634|NCT04950686|183340879|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.010
91723635|NCT04950686|183340879|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.119|TWO_SIDED||||||Mixed Models Analysis|||||||0.119
91723636|NCT04950686|183340880|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.161|TWO_SIDED||||||Mixed Models Analysis|||||||0.161
91723637|NCT04950686|183340880|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
91723638|NCT04950686|183340881|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.810
91723639|NCT04950686|183340881|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.901|TWO_SIDED||||||Mixed Models Analysis|||||||0.901
91723640|NCT04950686|183340882|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.145|TWO_SIDED||||||Mixed Models Analysis|||||||0.145
91723641|NCT04950686|183340882|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
91527955|NCT01103960|182930898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9195|STANDARD_ERROR_OF_MEAN|0.9015||0.034||95.0|0.1443|3.6947||This was the second step in the closed testing procedure of multiple endpoints. The p-value was again \<0.05 so this test was also considered confirmatory.|ANCOVA|||A5 minus T80/A5||3.6947|0.1443|0.034
91693353|NCT01205776|183281693|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Hazard Ratio (HR)|-3.1|||<|0.0001|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Com-Nougue|||||||<0.0001
91693354|NCT01205776|183281705|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Hazard Ratio (HR)|4.0||||0.011|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Com-Nougue Approach|||||||0.011
91693355|NCT01540487|183281783|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.5|||ANOVA|||||104.5|94.7|
91693356|NCT01540487|183281783|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
91693357|NCT01540487|183281784|SUPERIORITY_OR_OTHER||adjusted gMean ratio|101.9|||||TWO_SIDED|90.0|95.4|109.0|||ANOVA|||||109.0|95.4|
91693358|NCT01540487|183281784|SUPERIORITY_OR_OTHER||adjusted gMean ratio|111.4|||||TWO_SIDED|90.0|100.4|123.5|||ANOVA|||||123.5|100.4|
91693359|NCT01540487|183281785|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.0|||||TWO_SIDED|90.0|90.6|103.8|||ANOVA|||||103.8|90.6|
91693360|NCT01540487|183281785|SUPERIORITY_OR_OTHER||adjusteg gMean ratio|103.0|||||TWO_SIDED|90.0|96.2|110.1|||ANOVA|||||110.1|96.2|
91693361|NCT01540487|183281786|SUPERIORITY_OR_OTHER||adjusted gMean ratio|94.6|||||TWO_SIDED|90.0|85.4|104.8|||ANOVA|||||104.8|85.4|
91693362|NCT01540487|183281786|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.5|||||TWO_SIDED|90.0|92.2|113.9|||ANOVA|||||113.9|92.2|
91693363|NCT01540487|183281787|SUPERIORITY_OR_OTHER||adjusted gMean ratio|110.1|||||TWO_SIDED|90.0|100.5|120.6|||ANOVA|||||120.6|100.5|
91693364|NCT01540487|183281787|SUPERIORITY_OR_OTHER||adjusted gMean ratio|89.3|||||TWO_SIDED|90.0|80.2|99.3|||ANOVA|||||99.3|80.2|
91693365|NCT01540487|183281788|SUPERIORITY_OR_OTHER||adjusted gMean ratio|98.0|||||TWO_SIDED|90.0|92.0|104.5|||ANOVA|||||104.5|92.0|
91693366|NCT01540487|183281788|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.8|||||TWO_SIDED|90.0|97.0|109.0|||ANOVA|||||109.0|97.0|
91693367|NCT01540487|183281789|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.6|||ANOVA|||||104.6|94.7|
91693368|NCT01540487|183281789|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
91693369|NCT03503370|183281790|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.39|1.8|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.80|0.39|
91693370|NCT03503370|183281791|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91693371|NCT03503370|183281792|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.34|1.77|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.77|0.34|
91693372|NCT03483961|183281793|SUPERIORITY|||||||0.0015||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0015
91693373|NCT03483961|183281793|SUPERIORITY|||||||0.0761||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1.||Groups 2-8 are compared to Group 1||||0.0761
91693374|NCT03483961|183281793|SUPERIORITY|||||||0.9317||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.9317
91693375|NCT03483961|183281793|SUPERIORITY||||||<|0.0001||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1.||Groups 2-8 are compared to Group 1.||||<.0001
91693376|NCT03483961|183281793|SUPERIORITY|||||||0.0045||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0045
91693377|NCT03483961|183281793|SUPERIORITY|||||||0.1437||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.1437
91527956|NCT01103960|182930899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4879|STANDARD_ERROR_OF_MEAN|1.1217|<|0.001||95.0|2.2807|6.695|||ANCOVA|||A5 minus T80/A5||6.6950|2.2807|<0.001
91693378|NCT03483961|183281793|SUPERIORITY|||||||0.3216||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.3216
91693379|NCT00734162|183281836|SUPERIORITY_OR_OTHER||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant.|Cochran-Mantel-Haenszel|||Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.||||< 0.001
91693380|NCT05253573|183281873|SUPERIORITY||Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|1.21|2.83||||||The overall number of participants analyzed reflects the cancer survivors and/or independent caregivers. Participants are not represented separately (as cancer survivors or caregivers) for each Arm. This is because the originally proposed statistical data analysis plan did not aim to analyze the data by each group of caregivers versus cancer patients/survivors (because the statistical power would be very low for doing so||2.83|1.21|
91693381|NCT01754129|183281904|OTHER||||||<|0.001||||||Missing values were replaced using the Last Observation Carried Forward (LOCF) technique for data of questionnaires. Missing data at Visit 3 was replaced with the (non-missing) data recorded at Visit 2.|Paired t-test|||Mean change from baseline to Visit 3||||<0.001
91693382|NCT01754129|183281904|OTHER||||||<|0.001|||||||Paired t-test|||Change from baseline to Visit 2||||<0.001
91693383|NCT01085630|183281919|SUPERIORITY|||||||0.2423|||||||Fisher Exact|||||||0.2423
91527957|NCT04921969|182930907|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0001|TWO_SIDED|95.0|1.951|13.315||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.315|1.951|0.0001
91693384|NCT01237041|183281921|SUPERIORITY|Univariate ANOVA||||||0.016||||||A priori threshold p\<0.05|ANOVA|Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.||ANOVA to compare AUC of GH among groups||||.016
91693385|NCT01237041|183281922|SUPERIORITY|ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis||||||0.043||||||A priori threshold for significance p\<0.05|ANOVA|||Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.||||.043
91693386|NCT01237041|183281923|SUPERIORITY|||||||0.543|||||||ANOVA|||ANOVA, 3 dose-finding groups||||0.543
91693387|NCT01237041|183281924|SUPERIORITY|||||||0.113|||||||ANOVA|||ANOVA, 2 groups, essentially an unpaired t-test.||||.113
91693388|NCT00651261|183281941|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.009|TWO_SIDED|95.0|0.63|0.96|||1-sided stratified log-rank|||||0.96|0.63|0.009
91693389|NCT00651261|183281942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.0024|TWO_SIDED|95.0|0.66|0.93|||1-sided stratified log rank|||||0.93|0.66|0.0024
91693390|NCT00651261|183281944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Fisher Exact|||||||0.15
91693391|NCT00651261|183281945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||1-sided stratified log rank|||||||0.0049
91693392|NCT02027545|183281947|SUPERIORITY|||||||0.491|||||||Regression, Logistic|||||||0.491
91693393|NCT02027545|183281948|SUPERIORITY|||||||0.049|||||||Regression, Logistic|||||||0.049
91693394|NCT01017874|183281970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.217|TWO_SIDED|95.0|0.63|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.63|0.217
91693395|NCT01017874|183281971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.788|TWO_SIDED|95.0|0.68|1.31|||Wilcoxon (Mann-Whitney)|||||1.31|0.68|0.788
91693396|NCT01017874|183281974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.252|TWO_SIDED|95.0|0.63|1.14|||Wilcoxon (Mann-Whitney)|||||1.14|0.63|0.252
91693397|NCT01017874|183281975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.952|TWO_SIDED|95.0|0.53|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.53|0.952
91705779|NCT06010732|183305910|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.7||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.7|21.7|<0.001
91723642|NCT04950686|183340883|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.272|TWO_SIDED||||||Mixed Models Analysis|||||||0.272
91723643|NCT04950686|183340883|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.689|TWO_SIDED||||||Mixed Models Analysis|||||||0.689
91723644|NCT04950686|183340884|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
91723645|NCT04950686|183340884|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.271|TWO_SIDED||||||Mixed Models Analysis|||||||0.271
91723646|NCT04950686|183340885|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.391|TWO_SIDED||||||Mixed Models Analysis|||||||0.391
91723647|NCT04950686|183340885|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.952|TWO_SIDED||||||Mixed Models Analysis|||||||0.952
91723648|NCT04950686|183340886|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.925|TWO_SIDED||||||Mixed Models Analysis|||||||0.925
91723649|NCT04950686|183340886|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.153|TWO_SIDED||||||Mixed Models Analysis|||||||0.153
91723650|NCT04950686|183340887|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.495|TWO_SIDED||||||Mixed Models Analysis|||||||0.495
91723651|NCT04950686|183340887|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.229|TWO_SIDED||||||Mixed Models Analysis|||||||0.229
91723652|NCT04950686|183340888|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.753|TWO_SIDED||||||Mixed Models Analysis|||||||0.753
91723653|NCT04950686|183340888|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
91723654|NCT04950686|183340889|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.541|TWO_SIDED||||||Mixed Models Analysis|||||||0.541
91723655|NCT04950686|183340889|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
91527958|NCT04921969|182930907|SUPERIORITY||Odds Ratio (OR)|10.72|||<|0.0001|TWO_SIDED|95.0|4.429|30.042||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||30.042|4.429|<0.0001
91693398|NCT01790984|183281989|OTHER||General linear mixed model|2.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing differences between 2 Groups on 2 Diets (NAFLD, Control,high \& low sugar diets).|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TAG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
91693399|NCT01790984|183281990|OTHER||General linear mixed model|11.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size for NAFLD \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B and triacylglycerol production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level) produced sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
91693400|NCT01790984|183281991|OTHER||General linear mixed model|110.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
91705780|NCT06010732|183305911|SUPERIORITY||Ratio of Means|1.11||||0.23|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(EFU)||1.32|0.93|0.230
91723656|NCT04950686|183340890|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.375|TWO_SIDED||||||Mixed Models Analysis|||||||0.375
91723657|NCT04950686|183340890|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.293|TWO_SIDED||||||Mixed Models Analysis|||||||0.293
91723658|NCT04950686|183340891|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.97|STANDARD_ERROR_OF_MEAN|1.89||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
91759981|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.36|||||TWO_SIDED|95.0|-19.64|-1.08||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.08|-19.64|
91527959|NCT04921969|182930908|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4198|TWO_SIDED|95.0|0.61|3.268||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.268|0.610|0.4198
91489658|NCT01681472|182852169|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
91693401|NCT01790984|183281992|OTHER||General linear mixed model|0.26|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
91705364|NCT01306214|183305228|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.22|STANDARD_ERROR_OF_MEAN|3.05||0.0003|TWO_SIDED|97.5|-18.09|-4.36||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo.|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo"||-4.36|-18.09|0.0003
91489659|NCT01681472|182852169|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693402|NCT01790984|183281993|OTHER||General linear mixed model|10.0|||>|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables|Details of our statistical analyses are described below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||>0.05
91705365|NCT01306214|183305229|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.54|-1.24||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo"||-1.24|-3.54|<0.0001
91705781|NCT06010732|183305911|SUPERIORITY||Ratio of Means|5.77|||<|0.001|TWO_SIDED|95.0|4.86|6.85||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(EFU)||6.85|4.86|<0.001
91705782|NCT06010732|183305911|SUPERIORITY||Ratio of Means|5.2|||<|0.001|TWO_SIDED|95.0|4.37|6.18||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(EFU)||6.18|4.37|<0.001
91705783|NCT06010732|183305912|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.272|TWO_SIDED|95.0|-2.5|8.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||8.6|-2.5|0.272
91705784|NCT06010732|183305912|SUPERIORITY||Mean Difference (Final Values)|34.8|||<|0.001|TWO_SIDED|95.0|29.3|40.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||40.3|29.3|<0.001
91705785|NCT06010732|183305912|SUPERIORITY||Mean Difference (Final Values)|31.7|||<|0.001|TWO_SIDED|95.0|26.2|37.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||37.3|26.2|<0.001
91705786|NCT06010732|183305913|SUPERIORITY||Ratio of Means|1.11||||0.191|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(%CAR+100)||1.32|0.93|0.191
91705787|NCT06010732|183305913|SUPERIORITY||Ratio of Means|0.94||||0.003|TWO_SIDED|95.0|0.91|0.98||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(%CAR+100)||0.98|0.91|0.003
91705788|NCT06010732|183305913|SUPERIORITY||Ratio of Means|0.97||||0.092|TWO_SIDED|95.0|0.93|1.01||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(%CAR+100)||1.01|0.93|0.092
91705789|NCT06010732|183305914|SUPERIORITY||Ratio of Means|1.01||||0.905|TWO_SIDED|95.0|0.9|1.13||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(∆Z)||1.13|0.90|0.905
91705790|NCT06010732|183305914|SUPERIORITY||Ratio of Means|0.71|||<|0.001|TWO_SIDED|95.0|0.63|0.8||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(∆Z)||0.80|0.63|<0.001
91705791|NCT06010732|183305914|SUPERIORITY||Ratio of Means|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(∆Z)||0.79|0.63|<0.001
91723659|NCT04950686|183340891|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.21||0.163|TWO_SIDED||||||Mixed Models Analysis|||||||0.163
91723660|NCT04950686|183340892|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.09|STANDARD_ERROR_OF_MEAN|1.99||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
91723661|NCT04950686|183340892|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|2.27||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
91723662|NCT04950686|183340893|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.83|STANDARD_ERROR_OF_MEAN|2.06||0.064|TWO_SIDED||||||Mixed Models Analysis|||||||0.064
91723663|NCT04950686|183340893|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.37|STANDARD_ERROR_OF_MEAN|2.27||0.137|TWO_SIDED||||||Mixed Models Analysis|||||||0.137
91723664|NCT04950686|183340894|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.05|STANDARD_ERROR_OF_MEAN|1.52||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
91723665|NCT04950686|183340894|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.25|STANDARD_ERROR_OF_MEAN|1.76||0.065|TWO_SIDED||||||Mixed Models Analysis|||||||0.065
91723666|NCT04950686|183340895|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.67|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED||||||Mixed Models Analysis|||||||0.015
91723667|NCT04950686|183340895|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|1.78||0.152|TWO_SIDED||||||Mixed Models Analysis|||||||0.152
91723668|NCT04950686|183340896|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.78|STANDARD_ERROR_OF_MEAN|1.78||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
91723669|NCT04950686|183340896|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.13|STANDARD_ERROR_OF_MEAN|1.84||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
91723670|NCT04950686|183340897|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
91723671|NCT04950686|183340897|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.532|TWO_SIDED||||||Mixed Models Analysis|||||||0.532
91723672|NCT04950686|183340898|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
91527960|NCT04921969|182930908|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1685|TWO_SIDED|95.0|0.779|4.174||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.174|0.779|0.1685
91693403|NCT01790984|183281994|OTHER||General linear mixed model|0.28|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
91693404|NCT00375973|183282027|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Regression, Linear|||||||0.23
91693405|NCT00375973|183282028|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
91693406|NCT00375973|183282029|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Regression, Linear|||||||0.67
91693407|NCT00375973|183282030|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
91693408|NCT00375973|183282031|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
91693409|NCT00375973|183282032|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
91723673|NCT04950686|183340898|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.443|TWO_SIDED||||||Mixed Models Analysis|||||||0.443
91723674|NCT04950686|183340899|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
91723675|NCT04950686|183340899|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.726|TWO_SIDED||||||Mixed Models Analysis|||||||0.726
91723676|NCT04950686|183340900|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
91723677|NCT04950686|183340900|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.591|TWO_SIDED||||||Mixed Models Analysis|||||||0.591
91723678|NCT04950686|183340901|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
91489660|NCT01681472|182852170|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
91489661|NCT01681472|182852170|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
91693410|NCT00375973|183282033|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Fisher Exact|||||||0.24
91693411|NCT01691560|183282040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.4553|TWO_SIDED|95.0|-0.14|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.14|0.4553
91693412|NCT01691560|183282040|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07||||0.5689|TWO_SIDED|95.0|-0.16|0.3|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.30|-0.16|0.5689
91693413|NCT01691560|183282040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.7517|TWO_SIDED|95.0|-0.2|0.27|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.27|-0.20|0.7517
91723679|NCT04950686|183340901|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.359|TWO_SIDED||||||Mixed Models Analysis|||||||0.359
91723680|NCT04950686|183340902|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.rt-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
91723681|NCT04950686|183340902|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.198|TWO_SIDED||||||Mixed Models Analysis|||||||0.198
91723682|NCT04950686|183340903|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Mixed Models Analysis|||||||0.460
91723683|NCT04950686|183340903|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
91723684|NCT04950686|183340904|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
91723685|NCT04950686|183340904|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.939|TWO_SIDED||||||Mixed Models Analysis|||||||0.939
91723686|NCT04950686|183340905|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.655|TWO_SIDED||||||Mixed Models Analysis|||||||0.655
91723687|NCT04950686|183340905|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.315|TWO_SIDED||||||Mixed Models Analysis|||||||0.315
91723688|NCT04950686|183340906|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.04||0.966|TWO_SIDED||||||Mixed Models Analysis|||||||0.966
91723689|NCT04950686|183340906|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.708|TWO_SIDED||||||Mixed Models Analysis|||||||0.708
91723690|NCT04950686|183340907|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.04||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
91723691|NCT04950686|183340907|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
91723692|NCT04950686|183340908|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.217|TWO_SIDED||||||Mixed Models Analysis|||||||0.217
91723693|NCT04950686|183340908|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.879|TWO_SIDED||||||Mixed Models Analysis|||||||0.879
91723694|NCT04950686|183340909|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.866|TWO_SIDED||||||Mixed Models Analysis|||||||0.866
91723695|NCT04950686|183340909|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.695|TWO_SIDED||||||Mixed Models Analysis|||||||0.695
91723696|NCT04950686|183340910|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.06||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
91723697|NCT04950686|183340910|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.451|TWO_SIDED||||||Mixed Models Analysis|||||||0.451
91723698|NCT04950686|183340911|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.442|TWO_SIDED||||||Mixed Models Analysis|||||||0.442
91723699|NCT04950686|183340911|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.082|TWO_SIDED||||||Mixed Models Analysis|||||||0.082
91723700|NCT04950686|183340912|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED||||||Mixed Models Analysis|||||||0.236
91723701|NCT04950686|183340912|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.674|TWO_SIDED||||||Mixed Models Analysis|||||||0.674
91723702|NCT04950686|183340913|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.135|TWO_SIDED||||||Mixed Models Analysis|||||||0.135
91723703|NCT04950686|183340913|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.500
91723704|NCT04950686|183340914|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.09||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
91723705|NCT04950686|183340914|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.214|TWO_SIDED||||||Mixed Models Analysis|||||||0.214
91723706|NCT04950686|183340915|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.337|TWO_SIDED||||||Mixed Models Analysis|||||||0.337
91723707|NCT04950686|183340915|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.07||0.957|TWO_SIDED||||||Mixed Models Analysis|||||||0.957
91723708|NCT04950686|183340916|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.086|TWO_SIDED||||||Mixed Models Analysis|||||||0.086
91723709|NCT04950686|183340916|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
91723710|NCT04950686|183340917|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.597|TWO_SIDED||||||Mixed Models Analysis|||||||0.597
91759982|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.57|||||TWO_SIDED|95.0|-24.83|-6.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.32|-24.83|
91489662|NCT01681472|182852170|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91527961|NCT02791490|182930927|SUPERIORITY||Difference in Least Squares Means|-0.41|||<|0.001|TWO_SIDED|95.0|-0.59|-0.23|||Longitudinal Data Analysis|||||-0.23|-0.59|<0.001
91693414|NCT01691560|183282040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.8549|TWO_SIDED|95.0|-0.21|0.25|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.25|-0.21|0.8549
91693415|NCT01691560|183282040|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05||||0.6685|TWO_SIDED|95.0|-0.18|0.29|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-0.18|0.6685
91693416|NCT01691560|183282040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03||||0.8031|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA||Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.26|0.8031
91693417|NCT01691560|183282041|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0467|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0467
91693418|NCT01691560|183282041|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1133|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1133
91693419|NCT01691560|183282041|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2579||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.2579
91693420|NCT01691560|183282041|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6149|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.6149
91693421|NCT01691560|183282041|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3259|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.3259
91693422|NCT01691560|183282041|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5721|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.5721
91723711|NCT04950686|183340917|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.551|TWO_SIDED||||||Mixed Models Analysis|||||||0.551
91489663|NCT01681472|182852170|SUPERIORITY|||||||0.2725|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2725
91527962|NCT02791490|182930928|OTHER|95% CI|Difference in % vs Placebo|-1.7|||||TWO_SIDED|95.0|-10.8|7.4|||Miettinen and Nurminen method|||||7.4|-10.8|
91527963|NCT02791490|182930930|SUPERIORITY||Relative Risk|1.7||||0.002|TWO_SIDED|95.0|1.2|2.5|||Miettinen and Nurminen method|||||2.5|1.2|0.002
91693423|NCT01691560|183282042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.36||||0.0292|TWO_SIDED|95.0|0.04|0.69|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.69|0.04|0.0292
91693424|NCT01691560|183282042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4484|TWO_SIDED|95.0|-0.44|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.44|0.4484
91693425|NCT01691560|183282042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4537|TWO_SIDED|95.0|-0.45|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.45|0.4537
91693426|NCT01691560|183282042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49||||0.0037|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0037
91527964|NCT02791490|182930931|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.002|TWO_SIDED|95.0|-20.2|-4.6|||Longitudinal Data Analysis|||||-4.6|-20.2|0.002
91693427|NCT01691560|183282042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.004|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0040
91693428|NCT01691560|183282042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9974|TWO_SIDED|95.0|-0.32|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.32|0.9974
91693429|NCT01691560|183282043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8861|TWO_SIDED|95.0|-5.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|-5|0.8861
91693430|NCT01691560|183282043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0641|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0641
91693431|NCT01691560|183282043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1831||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1831
91693432|NCT01691560|183282043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0871|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.0871
91693433|NCT01691560|183282043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.169|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.1690
91693434|NCT01691560|183282043|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3829|TWO_SIDED|95.0|-5.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-5|0.3829
91693435|NCT01691560|183282044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.9421|TWO_SIDED|95.0|-0.74|0.8|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.80|-0.74|0.9421
91693436|NCT01691560|183282044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6918|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.60|-0.90|0.6918
91693437|NCT01691560|183282044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13||||0.7421|TWO_SIDED|95.0|-0.63|0.88|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.88|-0.63|0.7421
91693438|NCT01691560|183282044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18||||0.6433|TWO_SIDED|95.0|-0.58|0.94|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.94|-0.58|0.6433
91693439|NCT01691560|183282044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1||||0.801|TWO_SIDED|95.0|-0.86|0.67|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.67|-0.86|0.8010
91693440|NCT01691560|183282044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28||||0.4692|TWO_SIDED|95.0|-0.48|1.03|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.03|-0.48|0.4692
91693441|NCT01691560|183282045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.31||||0.4797|TWO_SIDED|95.0|-0.55|1.16|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.16|-0.55|0.4797
91723712|NCT04950686|183340918|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.634|TWO_SIDED||||||Mixed Models Analysis|||||||0.634
91723713|NCT04950686|183340918|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.308|TWO_SIDED||||||Mixed Models Analysis|||||||0.308
91489664|NCT01681472|182852170|SUPERIORITY|||||||0.1893|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1893
91489665|NCT01681472|182852170|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91693442|NCT01691560|183282045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.54||||0.2023|TWO_SIDED|95.0|-1.37|0.29|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-1.37|0.2023
91693443|NCT01691560|183282045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45||||0.2917|TWO_SIDED|95.0|-1.29|0.39|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.39|-1.29|0.2917
91693444|NCT01691560|183282045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.85||||0.0503|TWO_SIDED|95.0|0.0|1.69|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.69|0.00|0.0503
91693445|NCT01691560|183282045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.76||||0.0811|TWO_SIDED|95.0|-0.09|1.61|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.61|-0.09|0.0811
91693446|NCT01691560|183282045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.8322|TWO_SIDED|95.0|-0.75|0.93|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.93|-0.75|0.8322
91693447|NCT00232739|183282086|SUPERIORITY_OR_OTHER||Primary analysis posterior probability|0.9926||||||||||The primary analysis of comparing Sirolimus stent with POBA using Bayesian regression model yields that Sirolimus is superior to POBA in reducing the BAR risk.|Bayesian regression model|Multi-level Bayesian regression model was used in the secondary analysis|Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.|Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.||||
91723714|NCT04950686|183340919|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.415|TWO_SIDED||||||Mixed Models Analysis|||||||0.415
91723715|NCT04950686|183340919|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
91723716|NCT04950686|183340920|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.261|TWO_SIDED||||||Mixed Models Analysis|||||||0.261
91489666|NCT01681472|182852171|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489667|NCT01681472|182852171|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489668|NCT01681472|182852171|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91723717|NCT04950686|183340920|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.369|TWO_SIDED||||||Mixed Models Analysis|||||||0.369
91489669|NCT01681472|182852171|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
91489670|NCT01681472|182852171|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
91693448|NCT00676364|183282170|NON_INFERIORITY_OR_EQUIVALENCE|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|Mean Difference (Final Values)|2.1||||0.71|||||||Chi-squared||To assess the association between pain and anxiety with intervention group while controlling for other factors, linear regression was used.|P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.||||0.71
91693449|NCT01514292|183282174|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Fisher Exact|||"Hence, the hypothesis is established as:~Ho: pi \< 71.5% Ha: pi \>71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded."||||0.0001
91693450|NCT04157348|183282220|SUPERIORITY||Difference in remission rates|0.0121||||0.8773|TWO_SIDED|95.0|-0.1411|0.1653|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||0.1653|-0.1411|0.8773
91693451|NCT04157348|183282221|SUPERIORITY||difference in remission rates|0.0544|||||TWO_SIDED|95.0|-0.0746|0.1834|||Regression, Logistic|marginal standardization method||||0.1834|-0.0746|
91693452|NCT04157348|183282222|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.72|2.4|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|main remission||2.40|0.72|
91693453|NCT04157348|183282222|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.55|2.29|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|supportive remission||2.29|0.55|
91693454|NCT04157348|183282223|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.74|2.44|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|sustained main remission||2.44|0.74|
91693455|NCT04157348|183282223|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.64|2.34|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|sustained supportive remission||2.34|0.64|
91693456|NCT04157348|183282224|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.53|1.82|||Regression, Cox||The HR (Benralizumab vs. Mepolizumab) and 95% CI are estimated using a Cox regression model with Efron method to control for ties. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.82|0.53|
91693457|NCT04157348|183282225|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.56|1.9|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Mepolizumab) and the corresponding 95% CI are calculated using a negative binomial model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.90|0.56|
91723718|NCT04950686|183340921|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.124|TWO_SIDED||||||Mixed Models Analysis|||||||0.124
91489671|NCT01681472|182852171|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91489672|NCT01681472|182852172|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
91489673|NCT01681472|182852172|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693458|NCT04157348|183282227|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.75|2.54|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||2.54|0.75|
91693459|NCT04157348|183282228|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|0.96|3.22|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) for higher % reduction and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||3.22|0.96|
91723719|NCT04950686|183340921|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
91723720|NCT04950686|183340922|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
91723721|NCT04950686|183340922|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
91723722|NCT04950686|183340923|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.585|TWO_SIDED||||||Mixed Models Analysis|||||||0.585
91723723|NCT04950686|183340923|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.338|TWO_SIDED||||||Mixed Models Analysis|||||||0.338
91723724|NCT04950686|183340924|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.259|TWO_SIDED||||||Mixed Models Analysis|||||||0.259
91723725|NCT04950686|183340924|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.950
91723726|NCT04950686|183340925|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
91723727|NCT04950686|183340925|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.491|TWO_SIDED||||||Mixed Models Analysis|||||||0.491
91723728|NCT04950686|183340926|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.498|TWO_SIDED||||||Mixed Models Analysis|||||||0.498
91723729|NCT04950686|183340926|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.573|TWO_SIDED||||||Mixed Models Analysis|||||||0.573
91723730|NCT04950686|183340927|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.128|TWO_SIDED||||||Mixed Models Analysis|||||||0.128
91723731|NCT04950686|183340927|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
91723732|NCT04950686|183340928|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.0001|STANDARD_ERROR_OF_MEAN|0.07||0.999|TWO_SIDED||||||Mixed Models Analysis|||||||0.999
91723733|NCT04950686|183340928|EQUIVALENCE|This arm will receive Health Aware for Young Adults in between the pretest and posttest questionnaire. Health Aware for Young Adults is a web-based sexual and relationship health promotion program. The program contains the same health content as Media Aware for Young Adults but without the media literacy education components. The program is self-paced and includes four modules.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
91489674|NCT01681472|182852172|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0021
91723734|NCT04950686|183340929|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.841|TWO_SIDED||||||Mixed Models Analysis|||||||0.841
91489675|NCT01681472|182852172|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693460|NCT04157348|183282229|SUPERIORITY||difference in proportions|0.1079|||||TWO_SIDED|95.0|-0.0225|0.2383|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|\>=50% reduction||0.2383|-0.0225|
91693461|NCT04157348|183282229|SUPERIORITY||difference in proportions|0.1569|||||TWO_SIDED|95.0|0.0067|0.3017|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|100% reduction||0.3017|0.0067|
91693462|NCT04157348|183282229|SUPERIORITY||difference in proportions|-0.0068|||||TWO_SIDED|95.0|-0.1555|0.1418|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|OCS dose \<=4 mg/day||0.1418|-0.1555|
91693463|NCT04157348|183282230|SUPERIORITY||difference in response rates|0.046|||||TWO_SIDED|95.0|-0.0422|0.1341|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|any clinical response-definition 1||0.1341|-0.0422|
91693464|NCT04157348|183282230|SUPERIORITY||difference in response rates|0.079|||||TWO_SIDED|95.0|-0.0732|0.2312|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|complete response-definition 1||0.2312|-0.0732|
91693465|NCT04157348|183282231|SUPERIORITY||difference in remission rates|0.0554|||||TWO_SIDED|95.0|-0.093|0.2037|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|main remission||0.2037|-0.0930|
91693466|NCT04157348|183282231|SUPERIORITY||difference in remission rates|0.0467|||||TWO_SIDED|95.0|-0.1021|0.1956|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|supportive remission||0.1956|-0.1021|
91693467|NCT03020992|183282270|OTHER||Rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.116|0.281|||Poisson regression|||"The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods.~Event rates were based on a Poisson model with generalized estimating equations and a log-link, including an offset term for time interval length, and with period and disease duration of axSpA (\<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares."||0.281|0.116|<0.001
91693468|NCT05000164|183282302|SUPERIORITY||Least-square Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.17|-0.07|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.0 logMAR for distance.|Distance (4m)||-0.07|-0.17|
91693469|NCT05000164|183282302|SUPERIORITY||Least-square Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.06|0.04|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for intermediate.|Intermediate (64cm)||0.04|-0.06|
91693470|NCT05000164|183282302|SUPERIORITY||Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.04|0.15|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for near.|Near (40cm)||0.15|0.04|
91693471|NCT01006122|183282303|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.747||0.418|TWO_SIDED|80.0|-0.81|1.12|||Mixed Models Analysis|||One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.||1.12|-0.81|0.418
91489676|NCT01681472|182852172|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
91693472|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.457||0.054|TWO_SIDED|80.0|-1.32|-0.15|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.15|-1.32|0.054
91693473|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.453||0.247|TWO_SIDED|80.0|-0.89|0.27|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.27|-0.89|0.247
91693474|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.457||0.095|TWO_SIDED|80.0|-1.19|-0.01|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.01|-1.19|0.095
91693475|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|0.13|STANDARD_ERROR_OF_MEAN|0.487||0.604|TWO_SIDED|80.0|-0.5|0.75|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.75|-0.50|0.604
91489677|NCT01681472|182852172|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489678|NCT01681472|182852173|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91693476|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.473||0.232|TWO_SIDED|80.0|-0.95|0.26|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.26|-0.95|0.232
91693477|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.473||0.093|TWO_SIDED|80.0|-1.23|-0.02|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.02|-1.23|0.093
91693478|NCT01006122|183282304|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.498||0.274|TWO_SIDED|80.0|-0.94|0.34|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.34|-0.94|0.274
91693479|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.244||0.121|TWO_SIDED|80.0|-0.6|0.03|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.03|-0.60|0.121
91693480|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.243||0.394|TWO_SIDED|80.0|-0.38|0.25|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.25|-0.38|0.394
91693481|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.244||0.073|TWO_SIDED|80.0|-0.67|-0.04|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||-0.04|-0.67|0.073
91693482|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.495|TWO_SIDED|80.0|-0.34|0.33|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.33|-0.34|0.495
91693483|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.253||0.711|TWO_SIDED|80.0|-0.18|0.46|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.46|-0.18|0.711
91693484|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.253||0.767|TWO_SIDED|80.0|-0.14|0.51|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.51|-0.14|0.767
91693485|NCT01006122|183282305|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.266||0.698|TWO_SIDED|80.0|-0.2|0.48|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.48|-0.20|0.698
91693486|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.142||0.127|TWO_SIDED|80.0|-0.34|0.02|||Mixed Models Analysis|||Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.02|-0.34|0.127
91723735|NCT04950686|183340929|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.08||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.270
91693487|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.141||0.303|TWO_SIDED|80.0|-0.25|0.11|||Mixed Models Analysis|||Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.11|-0.25|0.303
91693488|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.738|TWO_SIDED|80.0|-0.09|0.27|||Mixed Models Analysis|||Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.27|-0.09|0.738
91693489|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|0.16|STANDARD_ERROR_OF_MEAN|0.152||0.85|TWO_SIDED|80.0|-0.04|0.35|||Mixed Models Analysis|||Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.35|-0.04|0.850
91693490|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|0.05|STANDARD_ERROR_OF_MEAN|0.148||0.631|TWO_SIDED|80.0|-0.14|0.24|||Mixed Models Analysis|||Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.24|-0.14|0.631
91723736|NCT04950686|183340930|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
91489679|NCT01681472|182852173|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693491|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.16|TWO_SIDED|80.0|-0.34|0.04|||Mixed Models Analysis|||Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.04|-0.34|0.160
91693492|NCT01006122|183282308|SUPERIORITY_OR_OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.156||0.541|TWO_SIDED|80.0|-0.18|0.22|||Mixed Models Analysis|||Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.22|-0.18|0.541
91693493|NCT03493854|183282320|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|1.14|1.31|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm A SC dose is inferior to the pertuzumab Arm B IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.31|1.14|
91693494|NCT03493854|183282321|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.33|||||TWO_SIDED|90.0|1.24|1.43|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.43|1.24|
91693495|NCT03493854|183282322|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|0.15|||||TWO_SIDED|95.0|-8.67|8.97|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||8.97|-8.67|
91693496|NCT03493854|183282323|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.5216|TWO_SIDED|95.0|0.68|2.11|||Log Rank|||||2.11|0.68|0.5216
91693497|NCT03493854|183282324|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.15||||0.5992|TWO_SIDED|95.0|0.68|1.97|||Log Rank|||||1.97|0.68|0.5992
91723737|NCT04950686|183340930|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.09||0.992|TWO_SIDED||||||Mixed Models Analysis|||||||0.992
91693498|NCT03493854|183282325|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.4844|TWO_SIDED|95.0|0.72|1.98|||Log Rank|||||1.98|0.72|0.4844
91693499|NCT03493854|183282326|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.16||||0.5474|TWO_SIDED|95.0|0.71|1.88|||Log Rank|||||1.88|0.71|0.5474
91693500|NCT03493854|183282327|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.17||||0.6291|TWO_SIDED|95.0|0.61|2.24|||Log Rank|||||2.24|0.61|0.6291
91693501|NCT03493854|183282328|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.26||||0.5609|TWO_SIDED|95.0|0.58|2.72|||Log Rank|||||2.72|0.58|0.5609
91693502|NCT02712554|183282360|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91693503|NCT02712554|183282360|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91693504|NCT02712554|183282360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2344|||||||ANOVA|||||||0.2344
91693505|NCT02712554|183282360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4737|||||||ANOVA|||||||0.4737
91693506|NCT02712554|183282360|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91693507|NCT02712554|183282360|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91693508|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
91693509|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
91693510|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1267|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1267
91693511|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1767|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1767
91693512|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
91723738|NCT04950686|183340931|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.470
91723739|NCT04950686|183340931|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.130
91723740|NCT04950686|183340932|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.931|TWO_SIDED||||||Mixed Models Analysis|||||||0.931
91723741|NCT04950686|183340932|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.666|TWO_SIDED||||||Mixed Models Analysis|||||||0.666
91723742|NCT04950686|183340933|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
91723743|NCT04950686|183340933|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
91723744|NCT04950686|183340934|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.540
91723745|NCT04950686|183340934|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.06||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
91723746|NCT04950686|183340935|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.175|TWO_SIDED||||||Mixed Models Analysis|||||||0.175
91723747|NCT04950686|183340935|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.136|TWO_SIDED||||||Mixed Models Analysis|||||||0.136
91723748|NCT04950686|183340936|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.829|TWO_SIDED||||||Mixed Models Analysis|||||||0.829
91489680|NCT01681472|182852173|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489681|NCT01681472|182852173|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91527965|NCT02960763|182930934|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.01||||||Equivalence of group|ANOVA|||||||0.010
91723749|NCT04950686|183340936|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.748|TWO_SIDED||||||Mixed Models Analysis|||||||0.748
91723750|NCT04950686|183340937|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.490
91723751|NCT04950686|183340937|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.831|TWO_SIDED||||||Mixed Models Analysis|||||||0.831
91527966|NCT02960763|182930934|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.004||||||augment with aripiprazole vs switch to bupropion|ANOVA|||||||0.004
91693513|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693514|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0119|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0119
91693515|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0025
91693516|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1679
91693517|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0318|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0318
91693518|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||0.0002
91693519|NCT02712554|183282364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<.0001
91693520|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
91693521|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
91693522|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0858|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0858
91693523|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2877|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2877
91693524|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
91693525|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693526|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0009
91693527|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0001
91693528|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1130
91693529|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0575|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0575
91693530|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<.0001
91693531|NCT02712554|183282365|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693532|NCT02712554|183282366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
91693533|NCT02712554|183282366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
91693534|NCT02712554|183282366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4025
91693535|NCT02712554|183282366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3184|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.3184
91693536|NCT02712554|183282366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
91693537|NCT02712554|183282366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693538|NCT02712554|183282367|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
91693539|NCT02712554|183282367|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
91693540|NCT02712554|183282367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2628|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2628
91693541|NCT02712554|183282367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2262|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2262
91693542|NCT02712554|183282367|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
91693543|NCT02712554|183282367|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693544|NCT02712554|183282368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
91693545|NCT02712554|183282368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
91693546|NCT02712554|183282368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1839|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1839
91693547|NCT02712554|183282368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1751|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1751
91693548|NCT02712554|183282368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
91693549|NCT02712554|183282368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693550|NCT02712554|183282369|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
91693551|NCT02712554|183282369|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
91693552|NCT02712554|183282369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4013
91693553|NCT02712554|183282369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0736|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0736
91723752|NCT04950686|183340938|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
91693554|NCT02712554|183282369|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
91693555|NCT02712554|183282369|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
91693556|NCT02712554|183282370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.001
91693557|NCT02712554|183282370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.001
91693558|NCT02712554|183282370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2223|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2223
91693559|NCT02712554|183282370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1638|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1638
91693560|NCT02712554|183282370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||0.0041
91693561|NCT02712554|183282370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.001
91693562|NCT02712554|183282371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0001
91693563|NCT02712554|183282371|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
91693564|NCT02712554|183282371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2706|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2706
91693565|NCT02712554|183282371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.5507
91693566|NCT02712554|183282371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||0.0047
91693567|NCT02712554|183282371|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693568|NCT02712554|183282372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0001
91693569|NCT02712554|183282372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||<0.0001
91693570|NCT02712554|183282372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0014
91693571|NCT02712554|183282372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0080
91693572|NCT02712554|183282372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<0.0001
91693573|NCT02712554|183282372|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693574|NCT02712554|183282373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0024
91693575|NCT02712554|183282373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||0.0012
91693576|NCT02712554|183282373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0037
91693577|NCT02712554|183282373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0011
91693578|NCT02712554|183282373|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
91693579|NCT02712554|183282373|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693580|NCT02712554|183282374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.0001
91693581|NCT02712554|183282374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.0001
91693582|NCT02712554|183282374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0630
91693583|NCT02712554|183282374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4436|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.4436
91693584|NCT02712554|183282374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<0.0001
91693585|NCT02712554|183282374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693586|NCT02712554|183282375|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
91693587|NCT02712554|183282375|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
91693588|NCT02712554|183282375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2335|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2335
91693589|NCT02712554|183282375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1808
91693590|NCT02712554|183282375|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
91693591|NCT02712554|183282375|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693592|NCT02712554|183282378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment C (low-dose M366) - Placebo||||<0.0001
91693593|NCT02712554|183282378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Treatment D: M366 37.5 mg/1625 mg, Treatment E: Placebo||||<0.0001
91693594|NCT02712554|183282378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1268
91693595|NCT02712554|183282378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0014
91693596|NCT02712554|183282378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Placebo||||<0.0001
91489682|NCT01681472|182852173|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
91693597|NCT02712554|183282378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693598|NCT02712554|183282379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
91693599|NCT02712554|183282379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
91693600|NCT02712554|183282379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0120
91693601|NCT02712554|183282379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||<0.0001
91693602|NCT02712554|183282379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
91693603|NCT02712554|183282379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
91693604|NCT03830333|183282417|NON_INFERIORITY|Ceftolozane/tazobactam + metronidazole is concluded to be non-inferior to meropenem + placebo if the lower bound of the 95% CI for the treatment difference in percent response is above -12.5 percentage points.|Difference in percentages|2.1|||||TWO_SIDED|95.0|-4.7|8.8||||||Difference in percentage was based on Miettinen and Nurminen method with the Cochran-Mantel-Haenszel (CMH) weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||8.8|-4.7|
91693605|NCT03830333|183282418|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-12.6|3.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||3.7|-12.6|
91693606|NCT03830333|183282419|OTHER||Difference in percentages|1.4|||||TWO_SIDED|95.0|-3.8|6.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||6.7|-3.8|
91723753|NCT04950686|183340938|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.235|TWO_SIDED||||||Mixed Models Analysis|||||||0.235
91723754|NCT04950686|183340939|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.682|TWO_SIDED||||||Mixed Models Analysis|||||||0.682
91693607|NCT03830333|183282420|OTHER||Difference in percentages|-1.5|||||TWO_SIDED|95.0|-8.0|4.8||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||4.8|-8.0|
91693608|NCT03830333|183282421|OTHER||Difference in percentages|1.2|||||TWO_SIDED|95.0|-9.2|10.4||||||Difference in percentage based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||10.4|-9.2|
91693609|NCT03830333|183282422|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.0|||||TWO_SIDED|95.0|-11.9|8.7||||||Gram-negative aerobes comparison: Based on unstratified Miettinen and Nurminen method.||8.7|-11.9|
91693610|NCT03830333|183282422|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-12.5|8.5||||||All enterobacteriaceae comparison: Based on unstratified Miettinen and Nurminen method.||8.5|-12.5|
91693611|NCT03830333|183282422|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-8.2|||||TWO_SIDED|95.0|-42.2|20.0||||||Gram-positive aerobes comparison: Based on unstratified Miettinen and Nurminen method.||20.0|-42.2|
91693612|NCT03830333|183282423|OTHER||Difference in Percentages|-0.7|||||TWO_SIDED|95.0|-12.6|11.2||||||Difference in percentage was based on Miettinen \& Nurminen method.||11.2|-12.6|
91693613|NCT03830333|183282424|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-4.4|4.4||||||Difference in percentage was based on Miettinen \& Nurminen method.||4.4|-4.4|
91693614|NCT01445730|183282425|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91723755|NCT04950686|183340939|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.373|TWO_SIDED||||||Mixed Models Analysis|||||||0.373
91489683|NCT01681472|182852173|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693615|NCT01445730|183282426|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91693616|NCT01445730|183282427|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91693617|NCT01445730|183282428|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91693618|NCT01445730|183282429|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
91693619|NCT01445730|183282430|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91693620|NCT01445730|183282431|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91693621|NCT01367886|183282432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53|STANDARD_DEVIATION|4.88||0.19|||||||t-test, 2 sided|||||||0.19
91693622|NCT01367886|183282433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_DEVIATION|0.87||0.0021|||||||t-test, 2 sided|||||||0.0021
91693623|NCT01367886|183282434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|1.02||0.18|||||||t-test, 2 sided|||||||0.18
91723756|NCT04950686|183340940|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.242|TWO_SIDED|95.0|0.24|6.63|||Mixed Models Analysis|||||6.63|0.24|0.242
91489684|NCT01681472|182852174|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
91693624|NCT01367886|183282435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|STANDARD_DEVIATION|1.34||0.0025|||||||t-test, 2 sided|||||||0.0025
91693625|NCT01938092|183282441|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
91693626|NCT01938092|183282442|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
91693627|NCT01938092|183282443|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91693628|NCT00985504|183282444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.612|TWO_SIDED|95.0|-1.87|1.1|||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||1.10|-1.87|0.612
91693629|NCT00985504|183282445|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||This is the p-value for Cognition Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.504
91693630|NCT00985504|183282445|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||This is the p-value for the Behavior Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.665
91693631|NCT00985504|183282445|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This is the p-value for Emotional Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.489
91693632|NCT00985504|183282445|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||This is the p-value for Other Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.945
91693633|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.157
91693634|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||This is the p-value for the Energy Level score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.119
91693635|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||This is the p-value for the Motivation and Interest score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.184
91693636|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||This is the p-value for the Cognitive Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.226
91693637|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is the p-value for the Weight Gain score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.059
91693638|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||This is the p-value for the Sleep score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.466
91693639|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||This is the p-value for the Sexual Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.822
91693640|NCT00985504|183282446|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||This is the p-value for the Affect score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.599
91693641|NCT00985504|183282447|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p-value for the PGI-I.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.723
91693642|NCT00985504|183282448|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.410
91693643|NCT00985504|183282449|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.880
91693644|NCT00985504|183282449|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||This is the p-value for the Item 8 (Inability to Feel) score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.224
91693645|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|95.0||||This is the p-value for the Total Score.|ANCOVA|ANCOVA main effect F test||||||0.910
91693646|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||This is the p-value for the Motivation/Interest/Enthusiasm Score.|ANCOVA|ANCOVA main effect F test||||||0.882
91693647|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||This is the p-value for the Wakefulness/Alertness Score.|ANCOVA|ANCOVA main effect F test||||||0.657
91693648|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||This is the p-value for the Energy Score.|ANCOVA|ANCOVA main effect F test||||||0.457
91693649|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||This is the p-value for the Ability to Focus/Sustain Attention Score.|ANCOVA|ANCOVA main effect F test||||||0.737
91693650|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||This is the p-value for the Ability to Remember/Recall Information Score.|ANCOVA|ANCOVA main effect F test||||||0.404
91489685|NCT01681472|182852174|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
91489686|NCT01681472|182852174|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91693651|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||This is the p-value for the Ability to Find Words Score.|ANCOVA|ANCOVA main effect F test||||||0.808
91693652|NCT00985504|183282450|SUPERIORITY_OR_OTHER|||||||0.431||95.0||||This is the p-value for the Sharpness/Mental Acuity Score.|ANCOVA|ANCOVA main effect F test||||||0.431
91693653|NCT00985504|183282451|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||This is the p-value for the SDS Total Score.|ANCOVA|ANCOVA main effect F test||||||0.821
91693654|NCT00985504|183282451|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||This is the p-value for the Item 1 (Work) Score.|ANCOVA|ANCOVA main effect F test||||||0.491
91527967|NCT02960763|182930934|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.017||||||augment with bupropion vs switch to bupropion|ANOVA|||||||0.017
91693655|NCT00985504|183282451|SUPERIORITY_OR_OTHER|||||||0.451||95.0||||This is the p-value for the Item 2 (Family) Score.|ANCOVA|ANCOVA main effect F test||||||0.451
91693656|NCT00985504|183282451|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||This is the p-value for the Item 3 (Social) Score.|ANCOVA|ANCOVA main effect F test||||||0.443
91693657|NCT00985504|183282451|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||This is the p-value for the Item 4 (Days Lost) Score.|ANCOVA|ANCOVA main effect F test||||||0.719
91693658|NCT00985504|183282451|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||This is the p-value for the Item 5 (Days Underproductive) Score.|ANCOVA|ANCOVA main effect F test||||||0.517
91693659|NCT00985504|183282452|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||||||0.776
91693660|NCT00985504|183282453|SUPERIORITY_OR_OTHER|||||||0.691||95.0|||||Log Rank|||The log-rank test was conducted using Kaplan-Meier Product-Limit method.||||0.691
91693661|NCT00985504|183282454|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||Fisher Exact|||||||0.724
91693662|NCT01465412|183282460|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.075|||||TWO_SIDED|90.0|0.695|1.662||||||The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||1.662|0.695|
91693663|NCT01465412|183282460|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.598|||||TWO_SIDED|90.0|1.334|5.06||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.060|1.334|
91693664|NCT01465412|183282461|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.305|||||TWO_SIDED|90.0|0.84|2.027||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.027|0.840|
91723757|NCT04950686|183340940|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.78||||0.207|TWO_SIDED|95.0|0.11|5.72|||Mixed Models Analysis|||||5.72|0.11|0.207
91723758|NCT04950686|183340941|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.88||||0.576|TWO_SIDED|95.0|0.51|1.52|||Mixed Models Analysis|||||1.52|0.51|0.576
91693665|NCT01465412|183282461|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.434|||||TWO_SIDED|90.0|0.643|3.198||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||3.198|0.643|
91693666|NCT01465412|183282462|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.852|||||TWO_SIDED|90.0|0.81|4.234||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||4.234|0.810|
91693667|NCT01465412|183282462|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.392|||||TWO_SIDED|90.0|1.306|4.382||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||4.382|1.306|
91693668|NCT01465412|183282463|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.548|||||TWO_SIDED|90.0|0.918|2.61||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.610|0.918|
91723759|NCT04950686|183340941|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
91723760|NCT04950686|183340942|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.87||||0.467|TWO_SIDED|95.0|0.22|3.45|||Mixed Models Analysis|||||3.45|0.22|0.467
91723761|NCT04950686|183340942|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
91693669|NCT01465412|183282463|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.407|||||TWO_SIDED|90.0|0.72|2.75||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.750|0.720|
91693670|NCT01465412|183282464|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.555|||||TWO_SIDED|90.0|0.617|3.917||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||3.917|0.617|
91693671|NCT01465412|183282464|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.806|||||TWO_SIDED|90.0|2.77|8.335||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||8.335|2.770|
91693672|NCT01465412|183282465|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.269|||||TWO_SIDED|90.0|0.703|2.288||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.288|0.703|
91693673|NCT01465412|183282465|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.98|||||TWO_SIDED|90.0|1.316|2.977||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.977|1.316|
91693674|NCT01465412|183282466|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.326|||||TWO_SIDED|90.0|0.749|2.348||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.348|0.749|
91693675|NCT01465412|183282466|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.041|||||TWO_SIDED|90.0|1.46|11.187||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||11.187|1.460|
91693676|NCT01465412|183282467|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.609|||||TWO_SIDED|90.0|1.007|2.572||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.572|1.007|
91693677|NCT01465412|183282467|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.231|||||TWO_SIDED|90.0|0.844|5.896||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.896|0.844|
91693678|NCT03805412|183282476|SUPERIORITY|||||||0.694|||||||t-test, 2 sided|||||||0.694
91693679|NCT03711786|183282477|SUPERIORITY||Odds Ratio (OR)|1.2||||0.836|TWO_SIDED|95.0|0.22|6.65|||Regression - GEE, logistic|From Wald z-statistic from generalized estimating equations (GEE) model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.65|0.22|0.836
91693680|NCT03711786|183282478|SUPERIORITY||Odds Ratio (OR)|0.86||||0.877|TWO_SIDED|95.0|0.12|6.14|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.14|0.12|0.877
91693681|NCT03711786|183282479|SUPERIORITY||Odds Ratio (OR)|18.36||||0.001|TWO_SIDED|95.0|3.23|104.23|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||104.23|3.23|0.001
91693682|NCT03711786|183282480|SUPERIORITY||Odds Ratio (OR)|2.15||||0.017|TWO_SIDED|95.0|1.15|4.01|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||4.01|1.15|0.017
91723762|NCT04950686|183340943|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
91723763|NCT04950686|183340943|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.432|TWO_SIDED||||||Mixed Models Analysis|||||||0.432
91723764|NCT04950686|183340944|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.031|TWO_SIDED||||||Mixed Models Analysis|||||||0.031
91693683|NCT03711786|183282481|SUPERIORITY||Odds Ratio (OR)|0.9||||0.759|TWO_SIDED|95.0|0.45|1.8|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||1.80|0.45|0.759
91693684|NCT07091916|183282497|OTHER|This objective was for the purpose of gathering data pertaining to device safety over the first 2 weeks post-implant. There were no pre-specified performance criteria or hypotheses for this objective.|Proportion|92.9|||||TWO_SIDED||||||descriptive statistics|||The first primary objective is to characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant. The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.||||
91693685|NCT07091916|183282498|OTHER|There were no hypotheses for this objective.|Proportion|100.0|||||||||||descriptive statistics|||The primary efficacy objective was to characterize the defibrillation efficacy at implant of the EV ICD System.||||
91693686|NCT05682729|183282514|SUPERIORITY||Partial Eta Squared|0.03||||0.41|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05. Wilks' Lambda F(3, 109) = .96, p = .41, ηp2 = .03.|ANCOVA|||We specifically compared the pre-to-post test change in accuracy on the FAM task across the four groups using a within-subjects ANCOVA and specifically a group by time (pre-to-post test) interaction. We controlled for age, gender, and children's executive function skills.||||.41
91693687|NCT05682729|183282514|SUPERIORITY||Partial Eta Squared|0.07||||0.004|TWO_SIDED||||||ANCOVA|||Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.||||.004
91693688|NCT05682729|183282514|SUPERIORITY||Partial Eta Squared|0.04||||0.031|TWO_SIDED||||||ANCOVA|||Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.||||.031
91693689|NCT05682729|183282514|SUPERIORITY||Partial Eta Squared|0.01||||0.463|TWO_SIDED||||||ANCOVA|||Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.||||.463
91693690|NCT05682729|183282514|SUPERIORITY||Partial Eta Squared|0.02||||0.186|TWO_SIDED||||||ANCOVA|||Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.||||.186
91693691|NCT05682729|183282515|SUPERIORITY||Partial Eta Squared|0.02||||0.605|TWO_SIDED||||||ANCOVA|||||||.605
91693692|NCT05682729|183282516|SUPERIORITY||Partial Eta Squared|0.02||||0.618|TWO_SIDED||||||ANCOVA|||||||.618
91693693|NCT03100903|183282552|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean ratio (%)|71.64|||||TWO_SIDED|90.0|60.57|84.73|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.7"|||84.73|60.57|
91723765|NCT04950686|183340944|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
91693694|NCT03100903|183282553|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|29.29|||||TWO_SIDED|90.0|24.27|35.35|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 26.6"|||35.35|24.27|
91723766|NCT04950686|183340945|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED||||||Mixed Models Analysis|||||||0.277
91723767|NCT04950686|183340945|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.115|TWO_SIDED||||||Mixed Models Analysis|||||||0.115
91693695|NCT03100903|183282554|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|70.22|||||TWO_SIDED|90.0|59.26|83.2|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.9"|||83.20|59.26|
91693696|NCT04659993|183282555|SUPERIORITY|To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. All statistical test used an alpha of 0.05.|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|7.8||0.8036|TWO_SIDED|95.0|-7.3|9.0||All statistical tests were performed with a significance level of 0.05.|t-test, 2 sided|||To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. All statistical test used an alpha of 0.05.||9.0|-7.3|0.8036
91723768|NCT02266576|183340969|OTHER|||||||0.04||||||The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.|Regression, Linear|||Baseline vs month 6||||0.04
91723769|NCT02266576|183340969|OTHER|||||||0.02|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12||||0.02
91693697|NCT04659993|183282556|SUPERIORITY|Paired t-test for Coronavirus Anxiety Scale. Statistical significance using alpha of 0.05.|Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.4||0.3632|TWO_SIDED|95.0|-0.6|0.3|||t-test, 2 sided|||||0.3|-0.6|0.3632
91527968|NCT02960763|182930934|SUPERIORITY|||||||0.65|||||||ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.650
91693698|NCT04659993|183282557|SUPERIORITY|Paired t-test of Purpose in life test. Statistical significance determine with alpha of 0.05.|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|9.7||0.7918|TWO_SIDED|95.0|-11.3|9.1|||t-test, 2 sided|||||9.1|-11.3|0.7918
91693699|NCT04659993|183282558|SUPERIORITY|Paired t-test of The Mini-Mental Adjustment to Cancer Anxious preoccupation Subscale. Statistical significance determine with alpha of 0.05.|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|5.3||0.7711|TWO_SIDED|95.0|-6.2|4.9|||t-test, 2 sided|||||4.9|-6.2|0.7711
91693700|NCT04659993|183282558|SUPERIORITY|Paired t-test of The Mini-Mental Adjustment to Cancer Cognitive avoidance Subscale. Statistical significance determine with alpha of 0.05.|Mean Difference (Final Values)|-5.3|STANDARD_DEVIATION|5.9||0.0772|TWO_SIDED|95.0|-11.5|0.8|||t-test, 2 sided|||||0.8|-11.5|0.0772
91693701|NCT04659993|183282558|SUPERIORITY|Paired t-test of The Mini-Mental Adjustment to Cancer Fatalism Subscale. Statistical significance determine with alpha of 0.05.|Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|5.6||0.2452|TWO_SIDED|95.0|-2.9|8.9|||t-test, 2 sided|||||8.9|-2.9|0.2452
91693702|NCT04659993|183282558|SUPERIORITY|Paired t-test of The Mini-Mental Adjustment to Cancer Fighting spirit Subscale. Statistical significance determine with alpha of 0.05.|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|8.3||0.6099|TWO_SIDED|95.0|-10.5|6.8|||t-test, 2 sided|||||6.8|-10.5|0.6099
91693703|NCT04659993|183282558|SUPERIORITY|Paired t-test of The Mini-Mental Adjustment to Cancer Helplessness/hopelessness Subscale. Statistical significance determine with alpha of 0.05.|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|3.5||0.0913|TWO_SIDED|95.0|-6.7|0.7|||t-test, 2 sided|||||0.7|-6.7|0.0913
91693704|NCT04850989|183282559|SUPERIORITY||Mean Difference (Net)|-5.14|STANDARD_DEVIATION|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
91693705|NCT04850989|183282560|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_DEVIATION|-1.23|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
91693706|NCT04850989|183282561|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
91693707|NCT04850989|183282562|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
91693708|NCT04850989|183282563|SUPERIORITY||Mean Difference (Net)|-3.48|STANDARD_DEVIATION|0.28|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||> 0.05
91693709|NCT00457002|183282584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.4364|TWO_SIDED|95.0|0.62|1.23|||Mantel Haenszel|||To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.||1.23|0.62|0.4364
91693710|NCT00457002|183282584|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39|||||TWO_SIDED|95.0|-1.37|0.59||||||||0.59|-1.37|
91693711|NCT00457002|183282585|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.69|1.63||||||Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.||1.63|0.69|
91693712|NCT00457002|183282585|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.61|0.81||||||||0.81|-0.61|
91693713|NCT00457002|183282586|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.7|1.71||||||||1.71|0.70|
91693714|NCT00457002|183282586|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.14|||||TWO_SIDED|95.0|-0.57|0.85||||||||0.85|-0.57|
91693715|NCT00457002|183282587|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.78|1.2||||||||1.20|0.78|
91723770|NCT02266576|183340970|OTHER|||||||0.004|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 6 in physical component score||||0.004
91723771|NCT02266576|183340970|OTHER|||||||0.01|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12 in physical component score||||0.01
91723772|NCT02906618|183340984|OTHER|A mixed-effect analysis of variance model was applied to the log-transformed dose-adjusted AUC(0-∞) of LY3039478 after oral dosing and IV administration of 13C 15N 2H-LY3039478. The model contained a fixed effect for formulation (oral or IV) and a random effect for participant.|Ratio of geometric LS means|0.572|||||TWO_SIDED|90.0|0.532|0.615||||||||0.615|0.532|
91723773|NCT04766333|183340991|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|0.17|1.23|||Regression, Logistic||Healthcare Arm is the reference category|||1.23|0.17|<0.05
91723774|NCT03807843|183341008|OTHER||V184 GMFR/Placebo GMFR Ratio|1.6||||0.004|TWO_SIDED|95.0|1.2|2.1|||Mixed Effects Model|||"Day 28 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 28 was derived from the mixed effects model used to determine GMFR."||2.1|1.2|0.004
91693716|NCT00457002|183282587|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-1.65|1.17||||||||1.17|-1.65|
91693717|NCT00457002|183282588|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.79|1.22||||||||1.22|0.79|
91693718|NCT00457002|183282588|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.12|||||TWO_SIDED|95.0|-1.52|1.29||||||||1.29|-1.52|
91723775|NCT03807843|183341008|OTHER||V184 GMFR/Placebo GMFR Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.8|||Mixed Effects Model|||"Day 56 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 56 was derived from the mixed effects model used to determine GMFR."||2.8|1.5|<0.001
91723776|NCT03807843|183341008|OTHER||V184 GMFR/Placebo GMFR Ratio|1.3||||0.121|TWO_SIDED|95.0|0.9|1.7|||Mixed Effects Model|||"Day 196 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 196 was derived from the mixed effects model used to determine GMFR."||1.7|0.9|0.121
91693719|NCT00457002|183282589|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||||1.29|0.65|
91693720|NCT00457002|183282589|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.26|||||TWO_SIDED|95.0|-1.23|0.71||||||||0.71|-1.23|
91693721|NCT00457002|183282590|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.11|4.05||||||||4.05|0.11|
91693722|NCT00457002|183282590|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.16|0.1||||||||0.10|-0.16|
91693723|NCT00457002|183282591|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.68|1.16||||||||1.16|0.68|
91693724|NCT00457002|183282591|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-1.25|0.48||||||||0.48|-1.25|
91693725|NCT00457002|183282592|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
91693726|NCT00457002|183282592|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-0.78|-0.03||||||||-0.03|-0.78|
91693727|NCT00457002|183282593|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.84|1.28||||||||1.28|0.84|
91693728|NCT00457002|183282593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-1.18|1.73||||||||1.73|-1.18|
91693729|NCT00457002|183282594|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
91693730|NCT00457002|183282594|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
91723777|NCT02734667|183341024|SUPERIORITY||t statistic from GLM/regression|-0.47||||0.64|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.64
91723778|NCT02734667|183341025|SUPERIORITY||t-statistic from GLM/regression results|-2.6||||0.013|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.013
91723779|NCT02734667|183341026|SUPERIORITY||t-statistic from GLM/regression results|3.12||||0.003|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.003
91723780|NCT05177094|183341040|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-0.7|0.4|||||Posterior mean difference with 95% credible interval is reported.|||0.40|-0.70|
91723781|NCT05177094|183341041|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.66|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.66|
91723782|NCT05177094|183341042|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.72|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.72|
91723783|NCT05177094|183341043|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.98|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.98|
91723784|NCT05177094|183341044|SUPERIORITY||Posterior Mean Difference|-0.22|||||TWO_SIDED|95.0|-0.61|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-0.61|
91693731|NCT00457002|183282595|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
91693732|NCT00457002|183282595|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
91693733|NCT00457002|183282596|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||||TWO_SIDED|95.0|0.11|0.83||||||||0.83|0.11|
91693734|NCT00457002|183282596|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.34|||||TWO_SIDED|95.0|-0.62|-0.07||||||||-0.07|-0.62|
91693735|NCT00457002|183282597|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.65|1.37||||||||1.37|0.65|
91693736|NCT00457002|183282597|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-1.04|0.76||||||||0.76|-1.04|
91693737|NCT00457002|183282598|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.29|-0.02||||||Note: Relative risk was not estimable (0.0); only risk difference could be estimated.||-0.02|-0.29|
91693738|NCT00457002|183282599|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||||TWO_SIDED|95.0|0.14|1.16||||||||1.16|0.14|
91693739|NCT00457002|183282599|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.22|||||TWO_SIDED|95.0|-0.47|0.03||||||||0.03|-0.47|
91693740|NCT00457002|183282600|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.29||||0.0437|TWO_SIDED|95.0|0.01|0.57||The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.|Mantel Haenszel|||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||0.57|0.01|0.0437
91693741|NCT00457002|183282601|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.36|||||TWO_SIDED|95.0|-0.33|1.06||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.06|-0.33|
91693742|NCT00457002|183282602|SUPERIORITY_OR_OTHER||Adjustted difference of event rates|0.59|||||TWO_SIDED|95.0|-16.0|1.33||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.33|-016|
91693743|NCT00457002|183282603|SUPERIORITY_OR_OTHER||Adjusted Difference of Event Rates|0.87|||||TWO_SIDED|95.0|-0.4|2.14||||||||2.14|-0.40|
91693744|NCT00457002|183282604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.61||||||||1.61|0.74|
91693745|NCT00457002|183282604|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.66|1.07||||||||1.07|-0.66|
91723785|NCT05177094|183341045|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.58|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.58|
91723786|NCT05177094|183341046|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.68|0.45|||||Posterior mean difference with 95% credible interval is reported.|||0.45|-0.68|
91723787|NCT05177094|183341047|SUPERIORITY||Posterior Mean Difference|0.06|||||TWO_SIDED|95.0|-0.65|0.77|||||Posterior mean difference with 95% credible interval is reported.|||0.77|-0.65|
91723788|NCT05177094|183341048|SUPERIORITY||Posterior Mean Difference|-3.09|||||TWO_SIDED|95.0|-10.43|4.28|||||Posterior mean difference with 95% credible interval is reported.|||4.28|-10.43|
91723789|NCT05177094|183341049|SUPERIORITY||Posterior Mean Difference|-1.5|||||TWO_SIDED|95.0|-10.04|7.0|||||Posterior mean difference with 95% credible interval is reported.|||7.00|-10.04|
91723790|NCT05177094|183341050|SUPERIORITY||Posterior Mean Difference|0.12|||||TWO_SIDED|95.0|-0.32|0.54|||||Posterior mean difference with 95% credible interval is reported.|||0.54|-0.32|
91723791|NCT05177094|183341051|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.24|0.65|||||Posterior mean difference with 95% credible interval is reported.|||0.65|-0.24|
91723792|NCT05177094|183341052|SUPERIORITY||Posterior Mean Difference|44.36|||||TWO_SIDED|95.0|-114.73|204.0|||||Posterior mean difference with 95% credible interval is reported.|||204.00|-114.73|
91723793|NCT05177094|183341053|SUPERIORITY||Posterior Mean Difference|-98.76|||||TWO_SIDED|95.0|-231.86|34.49|||||Posterior mean difference with 95% credible interval is reported.|||34.49|-231.86|
91723794|NCT05177094|183341054|SUPERIORITY||Posterior Mean Difference|0.01|||||TWO_SIDED|95.0|-0.05|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.05|
91723795|NCT05177094|183341055|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
91723796|NCT00138294|183341059|OTHER||Incidence Rate Ratio|0.89|||||TWO_SIDED|95.0|0.87|0.91||||||Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)||0.91|0.87|
91527969|NCT02960763|182930934|SUPERIORITY|||||||0.003||||||augmentation versus switch|ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.003
91723797|NCT00138294|183341060|OTHER||Incidence Rate Ratio|0.69|||||TWO_SIDED|95.0|0.67|0.71||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.71|0.67|
91723798|NCT00138294|183341061|OTHER||Incidence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.73|0.76||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.76|0.73|
91723799|NCT02827708|183341070|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.0|<0.0001
91723800|NCT02827708|183341070|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.0|||<|0.0001||95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
91723801|NCT02827708|183341071|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.8|-3.2|<0.0001
91723802|NCT02827708|183341071|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.9||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.9|-3.5|<0.0001
91723803|NCT02827708|183341087|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.64|||=|0.1834|TWO_SIDED|95.0|0.34|1.23||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.23|0.34|=0.1834
91723804|NCT02827708|183341088|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.43|||=|0.061|TWO_SIDED|95.0|0.17|1.04||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.04|0.17|=0.0610
91527970|NCT02960763|182930934|SUPERIORITY|For those who proceed to Step 2, analogous repeated measures 2\*2\*2 ANOVA will be used with a significance level of .05 for the time\*treatment group comparison.||||||0.385|||||||ANOVA|||||||0.385
91693746|NCT00457002|183282613|SUPERIORITY_OR_OTHER||Adjusted Event rate difference|0.0|||||TWO_SIDED|95.0|-0.3|0.29|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference in event rates in MI or stroke.||0.29|-0.30|
91693747|NCT00457002|183282613|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|0.09|||||TWO_SIDED|95.0|-0.11|0.3|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates for myocardial infarction.||0.30|-0.11|
91693748|NCT00457002|183282613|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|-0.1|||||TWO_SIDED|95.0|-0.32|0.12||||||Adjusted difference in event rates for stroke.||0.12|-0.32|
91693749|NCT00457002|183282613|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|0.09|||||TWO_SIDED|95.0|-0.09|0.28|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates in thrombocytopenia.||0.28|-0.09|
91693750|NCT01234870|183282632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality||||<0.001
91693751|NCT01262287|183282634|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
91693752|NCT01262287|183282635|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
91693753|NCT01262287|183282635|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
91693754|NCT00789373|183282709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||6e-05|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).||0.79|0.49|0.00006
91693755|NCT00789373|183282710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0002|TWO_SIDED|95.0|0.51|0.81|||Log Rank|||||0.81|0.51|0.0002
91693756|NCT00789373|183282711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0195|TWO_SIDED|95.0|0.64|0.96||The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.|Log Rank||Unadjusted HR from Cox model with treatment as the only cofactor.|Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.||0.96|0.64|0.0195
91693757|NCT04994691|183282720|SUPERIORITY||Risk Ratio (RR)|1.92||||0|TWO_SIDED|95.0|1.38|2.6|||Regression, Logistic||Standard Message vs. No Message|||2.60|1.38|0.000
91693758|NCT04994691|183282720|SUPERIORITY||Risk Ratio (RR)|1.52||||0.023|TWO_SIDED|95.0|1.06|2.13|||Regression, Logistic||Tailored Message vs. No Message|||2.13|1.06|0.023
91693759|NCT04994691|183282720|SUPERIORITY||Risk Ratio (RR)|1.26||||0.124|TWO_SIDED|95.0|0.94|1.66|||Regression, Logistic||Standard Message vs. Tailored Message|||1.66|0.94|0.124
91693760|NCT04994691|183282721|SUPERIORITY||Risk Ratio (RR)|1.97||||0.001|TWO_SIDED|95.0|1.32|2.84|||Regression, Logistic||Standard Message vs. No Message|||2.84|1.32|0.001
91693761|NCT04994691|183282721|SUPERIORITY||Risk Ratio (RR)|1.57||||0.04|TWO_SIDED|95.0|1.02|2.34|||Regression, Logistic||Tailored Message vs. No Message|||2.34|1.02|0.040
91693762|NCT04994691|183282721|SUPERIORITY||Risk Ratio (RR)|1.26||||0.202|TWO_SIDED|95.0|0.88|1.74|||Regression, Logistic||Standard Message vs. Tailored Message|||1.74|0.88|0.202
91693763|NCT04244084|183282726|SUPERIORITY||Median Difference (Final Values)|-0.89||||0.0155|TWO_SIDED|95.0|-1.61|-0.17|||ANCOVA|Site used as covariate||Mean differences (MMH-407 vs. Placebo) were compared||-0.17|-1.61|0.0155
91693764|NCT04244084|183282727|SUPERIORITY|||||||0.1839|||||||Wilcoxon (Mann-Whitney)|||||||0.1839
91693765|NCT04244084|183282728|SUPERIORITY|||||||0.064||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0640
91693766|NCT04244084|183282729|SUPERIORITY|||||||0.1927|||||||Wilcoxon (Mann-Whitney)|||||||0.1927
91693767|NCT04244084|183282730|SUPERIORITY|||||||0.0014||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0014
91693768|NCT04244084|183282731|SUPERIORITY|||||||0.2009|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 1 row."||||0.2009
91693769|NCT04244084|183282731|SUPERIORITY|||||||0.4717|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 2 row."||||0.4717
91693770|NCT04244084|183282731|SUPERIORITY|||||||0.5144|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 3 row."||||0.5144
91693771|NCT04244084|183282732|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
91693772|NCT04244084|183282734|SUPERIORITY|||||||0.5981|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 1 row."||||0.5981
91693773|NCT04244084|183282734|SUPERIORITY|||||||0.4913|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 2 row."||||0.4913
91693774|NCT04244084|183282734|SUPERIORITY|||||||0.6441|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 3 row."||||0.6441
91693775|NCT04244084|183282734|SUPERIORITY|||||||0.8186|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 1 row."||||0.8186
91693776|NCT04244084|183282734|SUPERIORITY|||||||0.8931|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 2 row."||||0.8931
91693777|NCT04244084|183282734|SUPERIORITY|||||||0.5887|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 3 row."||||0.5887
91693778|NCT04244084|183282735|SUPERIORITY|||||||0.4426|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 1 row."||||0.4426
91693779|NCT04244084|183282735|SUPERIORITY|||||||0.5998|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 2 row."||||0.5998
91693780|NCT04244084|183282735|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 3 row."||||0.9710
91693781|NCT04244084|183282736|SUPERIORITY|||||||0.6197|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 1 row."||||0.6197
91693782|NCT04244084|183282736|SUPERIORITY|||||||0.7042|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 2 row."||||0.7042
91693783|NCT04244084|183282736|SUPERIORITY|||||||0.7693|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 3 row."||||0.7693
91693784|NCT04244084|183282737|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91693785|NCT02268916|183282766|SUPERIORITY|The study was powered based on a two-sample t-test of the primary outcomes, changes in physical activity or social participant over 6 months. Based on previous literature, in order to detect an effect size of 0.28 with at least 70% power, we aimed to recruit at least 35 participants in each treatment group.|Mean Difference (Final Values)|0.39|||=|0.18|TWO_SIDED|95.0|-0.18|0.97|||Mixed Models Analysis|The outcome was adjusted for time of visit, visit x intervention group, age, gender, body mass index, insulin, depression, and time-up-and-go score.||We hypothesized that at the end of 6 months, the intervention group will have increased physical activity as measured by CHAMPS compared to the control group.||0.97|-0.18|=0.18
91693786|NCT02268916|183282767|SUPERIORITY||Slope|-2.2||||0.19|TWO_SIDED|95.0|-5.45|1.06|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in social roles.||1.06|-5.45|0.19
91693787|NCT02268916|183282767|SUPERIORITY||Slope|-1.02||||0.57|TWO_SIDED|95.0|-4.53|2.48|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in discretionary social activities.||2.48|-4.53|0.57
91693788|NCT02268916|183282767|SUPERIORITY||Slope|-2.44||||0.12|TWO_SIDED|95.0|-5.52|0.63|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities.||0.63|-5.52|0.12
91693789|NCT02268916|183282768|SUPERIORITY||Slope|-1.99|||<|0.05|TWO_SIDED|95.0|-3.97|-0.02|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in timed up and go test.||-0.02|-3.97|<0.05
91693790|NCT02268916|183282769|SUPERIORITY||Slope|0.11||||0.02|TWO_SIDED|95.0|0.02|0.2|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in gait speed.||0.20|0.02|0.02
91489687|NCT01681472|182852174|SUPERIORITY|||||||0.1551|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1551
91489688|NCT01681472|182852174|SUPERIORITY|||||||0.1563|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1563
91693791|NCT02268916|183282770|SUPERIORITY||Slope|40.04||||0.02|TWO_SIDED|95.0|7.9|72.17|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in six-minute walk test.||72.17|7.90|0.02
91693792|NCT04830969|183282784|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.16
91693793|NCT04830969|183282785|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.08
91693794|NCT04830969|183282786|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.14
91693795|NCT04830969|183282786|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.8
91693796|NCT04830969|183282787|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||<0.01
91693797|NCT04830969|183282787|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.09
91693798|NCT04830969|183282788|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
91693799|NCT04830969|183282788|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.03
91693800|NCT04830969|183282789|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
91489689|NCT01681472|182852174|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91693801|NCT04830969|183282789|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.09
91693802|NCT04830969|183282790|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
91693803|NCT04830969|183282790|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.86
91693804|NCT04830969|183282790|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||Baseline to 6 months||||0.047
91693805|NCT04830969|183282790|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.75
91693806|NCT04830969|183282791|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Baseline to 3 months||||0.44
91693807|NCT04830969|183282791|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.22
91693808|NCT04830969|183282791|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Baseline to 6 months||||0.29
91693809|NCT04830969|183282791|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.15
91693810|NCT04830969|183282792|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Baseline to 3 months||||<0.01
91693811|NCT04830969|183282792|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.31
91693812|NCT04830969|183282792|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
91693813|NCT04830969|183282792|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.54
91693814|NCT04830969|183282793|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
91693815|NCT04830969|183282793|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.04
91693816|NCT04830969|183282793|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline to 6 months||||0.03
91693817|NCT04830969|183282793|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.38
91693818|NCT04830969|183282794|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline to 3 months||||0.02
91693819|NCT04830969|183282794|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.18
91693820|NCT04830969|183282794|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
91693821|NCT04830969|183282794|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.41
91693822|NCT04830969|183282795|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.27
91693823|NCT04830969|183282796|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.54
91693824|NCT04830969|183282797|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.12
91693825|NCT04830969|183282798|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
91693826|NCT04830969|183282798|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.07
91527971|NCT02960763|182930935|SUPERIORITY|||||||0.038||||||Group effect|generalized linear model with logistic l|||||||0.038
91723805|NCT00407511|183341116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If \< = 7 and \> = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.||||< 0.0001
91723806|NCT00407511|183341117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4||-2.8|-3.6|< 0.0001
91723807|NCT00407511|183341117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.3|-3.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8||-3.5|-4.3|< 0.0001
91527972|NCT02960763|182930935|SUPERIORITY|||||||0.021||||||augmentation with aripiprazole vs switch to bupropion|generalized linear model with logistic l|||||||0.021
91527973|NCT02960763|182930935|SUPERIORITY|||||||0.027||||||augmentation with bupropion vs switch to bupropion|generalized linear model with logistic l|||||||0.027
91693827|NCT04830969|183282799|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91693828|NCT04830969|183282799|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.64
91693829|NCT04830969|183282800|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91693830|NCT04830969|183282800|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.11
91693831|NCT04830969|183282801|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||at baseline||||0.7
91693832|NCT04830969|183282801|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||6 months||||0.29
91693833|NCT04830969|183282802|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
91693834|NCT02748356|183282819|OTHER|1 sample t-test|||||=|0.351|||||||t-test, 2 sided|This is a single group comparison||||||=0.351
91693835|NCT03482635|183282878|OTHER||Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.105|0.202|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.202|-0.105|
91693836|NCT03482635|183282878|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
91693837|NCT03482635|183282878|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
91693838|NCT03482635|183282879|OTHER||Risk Difference (RD)|-0.051|||||TWO_SIDED|95.0|-0.276|0.176|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.176|-0.276|
91693839|NCT03482635|183282879|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.199|0.28|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.280|-0.199|
91693840|NCT03482635|183282879|OTHER||Risk Difference (RD)|0.033|||||TWO_SIDED|95.0|-0.204|0.252|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.252|-0.204|
91693841|NCT03482635|183282880|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.258|-0.072|
91693842|NCT03482635|183282880|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
91693843|NCT03482635|183282880|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
91693844|NCT03482635|183282881|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.258|-0.072|
91693845|NCT03482635|183282881|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.104|0.21|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.210|-0.104|
91693846|NCT03482635|183282881|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.11|0.177|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.177|-0.110|
91527974|NCT02960763|182930935|SUPERIORITY|||||||0.934||||||Augmentation with aripiprazole v augmentation with bupropion|generalized linear model with logistic l|||||||0.934
91693847|NCT03482635|183282882|OTHER||Difference of adjusted means|-0.3|STANDARD_ERROR_OF_MEAN|10.7||0.9776|TWO_SIDED|95.0|-21.6|21.0|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||21.0|-21.6|0.9776
91693848|NCT03482635|183282882|OTHER||Difference of adjusted means|1.4|STANDARD_ERROR_OF_MEAN|10.6||0.894|TWO_SIDED|95.0|-19.6|22.4|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||22.4|-19.6|0.8940
91693849|NCT03482635|183282882|OTHER||Difference of adjusted means|1.0|STANDARD_ERROR_OF_MEAN|10.6||0.9241|TWO_SIDED|95.0|-20.0|22.1|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements||22.1|-20.0|0.9241
91693850|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.0415||||0.3184|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the Emax curve model based on all 3 dosage data points, not just the 0.5mg/kg point presented here.|Mixed Models Analysis|See Statistical Analysis 2 and 3 for the other two data points (1.0mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||"The purpose of this analysis is to determine whether a dose-response relationship exists, with multiple possible models (Emax and sigEmax) being tested. gMCP-Mod analysis (Generalized Multiple Comparisons and Modeling) was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low HCT). 2) Multiple contrast test. 3) Find best-fit dose-response model.~Emax model analysis is shown here."||||0.3184
91693851|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.1225||||0.3184|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the Emax curve model based on all 3 dosage data points, not just the 1.0mg/kg point presented here.|Mixed Models Analysis|See Statistical Analysis 1 and 3 for the other two data points (0.5mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||"The purpose of this analysis is to determine whether a dose-response relationship exists, with multiple possible models (Emax and sigEmax) being tested. gMCP-Mod analysis (Generalized Multiple Comparisons and Modeling) was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low HCT). 2) Multiple contrast test. 3) Find best-fit dose-response model.~Emax model analysis is shown here."||||0.3184
91693852|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.208||||0.3184|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the Emax curve model based on all 3 dosage data points, not just the 2.0mg/kg point presented here.|Mixed Models Analysis|See Statistical Analysis 1 and 2 for the other two data points (0.5mg/kg and 1.0mg/kg) that are part of this same curve and p-value analysis.||"The purpose of this analysis is to determine whether a dose-response relationship exists, with multiple possible models (Emax and sigEmax) being tested. gMCP-Mod analysis (Generalized Multiple Comparisons and Modeling) was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low HCT). 2) Multiple contrast test. 3) Find best-fit dose-response model.~Emax model analysis is shown here."||||0.3184
91705792|NCT06010732|183305915|SUPERIORITY||Ratio of Means|0.98||||0.721|TWO_SIDED|95.0|0.88|1.09||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(lesion depth)||1.09|0.88|0.721
91527975|NCT02960763|182930935|SUPERIORITY|||||||0.011||||||augmentation versus switch|generalized linear model with logistic l|||||||0.011
91527976|NCT02960763|182930935|SUPERIORITY|||||||0.5|||||||generalized linear model with logistic l|||||||0.500
91527977|NCT02960763|182930936|SUPERIORITY|||||||0.164||||||Cox models time to event comparing treatment arms.|Regression, Cox|||||||0.164
91527978|NCT02960763|182930936|SUPERIORITY|||||||0.103|||||||Regression, Cox|||||||0.103
91527979|NCT02960763|182930936|SUPERIORITY|||||||0.127|||||||Regression, Cox|||||||0.127
91693853|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.0415||||0.2265|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the sigEmax curve model based on data points for all 3 dosages, not just the 0.5mg/kg point presented here.|Mixed Models Analysis|See Statistical Analysis 5 and 6 for the other two data points (1.0mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||"The purpose of this analysis is to determine whether a dose-response relationship exists, with multiple possible models (Emax and sigEmax) being tested. gMCP-Mod analysis (Generalized Multiple Comparisons and Modeling) was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low HCT). 2) Multiple contrast test. 3) Find best-fit dose-response model.~sigEmax model analysis is shown here."||||0.2265
91693854|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.1225||||0.2265|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the sigEmax curve model based on data points for all 3 dosages, not just the 1.0mg/kg point presented here.|Mixed Models Analysis|See Statistical Analysis 4 and 6 for the other two data points (0.5mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||"The purpose of this analysis is to determine whether a dose-response relationship exists, with multiple possible models (Emax and sigEmax) being tested. gMCP-Mod analysis (Generalized Multiple Comparisons and Modeling) was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low HCT). 2) Multiple contrast test. 3) Find best-fit dose-response model.~sigEmax model analysis is shown here."||||0.2265
91693855|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.208||||0.2265|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the sigEmax curve model based on data points for all 3 dosages, not just the 2.0mg/kg point presented here.|Mixed Models Analysis|See Statistical Analysis 4 and 5 for the other two data points (0.5mg/kg and 1.0mg/kg) that are part of this same curve and p-value analysis.||"The purpose of this analysis is to determine whether a dose-response relationship exists, with multiple possible models (Emax and sigEmax) being tested. gMCP-Mod analysis (Generalized Multiple Comparisons and Modeling) was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low HCT). 2) Multiple contrast test. 3) Find best-fit dose-response model.~sigEmax model analysis is shown here."||||0.2265
91693856|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.2671||||0.0764|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the Emax curve model for high HCT based on all 3 dosage data points, not just the 0.5mg/kg point shown here.|Mixed Models Analysis|See Statistical Analysis 8 and 9 for the other two data points (1.0mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||The purpose of this analysis is to determine whether a dose-response relationship exists for only the subset of patients with high HCT. Multiple possible models (Emax and sigEmax) were tested. gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression, stratification by sex 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.0764
91705793|NCT06010732|183305915|SUPERIORITY||Ratio of Means|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(lesion depth)||0.84|0.68|<0.001
91723808|NCT00407511|183341117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12||-3.7|-4.5|< 0.0001
91489690|NCT01681472|182852175|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91527980|NCT02960763|182930936|SUPERIORITY|||||||0.524||||||Cox models to examine time to event comparing treatment arms.|Regression, Cox|||||||0.524
91527981|NCT01928225|182930969|SUPERIORITY||Risk Ratio (RR)|1.18||||0.29|TWO_SIDED|95.0|0.87|1.6||\<0.05 was considered statistically significant.|Chi-squared|||||1.6|.87|.29
91527982|NCT01928225|182930970|SUPERIORITY||Risk Ratio (RR)|1.26||||0.22|TWO_SIDED|95.0|0.85|1.95|||Chi-squared|||||1.95|.85|.22
91489691|NCT01681472|182852175|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693857|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.6561||||0.0764|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the Emax curve model for high HCT based on all 3 dosage data points, not just the 1.0mg/kg point shown here.|Mixed Models Analysis|See Statistical Analysis 7 and 9 for the other two data points (0.5mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||The purpose of this analysis is to determine whether a dose-response relationship exists for only the subset of patients with high HCT. Multiple possible models (Emax and sigEmax) were tested. gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression, stratification by sex 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.0764
91693858|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.4668||||0.0764|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to the fit of the Emax curve model for high HCT based on all 3 dosage data points, not just the 2.0mg/kg point shown here.|Mixed Models Analysis|See Statistical Analysis 7 and 8 for the other two data points (0.5mg/kg and 1.0mg/kg) that are part of this same curve and p-value analysis.||The purpose of this analysis is to determine whether a dose-response relationship exists for only the subset of patients with high HCT. Multiple possible models (Emax and sigEmax) were tested. gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression, stratification by sex 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.0764
91693859|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.2671||||0.0574|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model for high HCT based on all 3 dosage data points, not just the 0.5mg/kg point shown here.|Mixed Models Analysis|See Statistical Analysis 11 and 12 for the other two data points (1.0mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||The purpose of this analysis is to determine whether a dose-response relationship exists for the subset of patients with high HCT. Multiple possible models (Emax and sigEmax) were tested. gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression, stratification by sex 2) Multiple contrast test 3) Find best-fit dose-response model. sigEmax model analysis is shown here.||||0.0574
91693860|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.6561||||0.0574|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model for high HCT based on all 3 dosage data points, not just the 1.0mg/kg point shown here.|Mixed Models Analysis|See Statistical Analysis 10 and 12 for the other two data points (0.5mg/kg and 2.0mg/kg) that are part of this same curve and p-value analysis.||The purpose of this analysis is to determine whether a dose-response relationship exists for the subset of patients with high HCT. Multiple possible models (Emax and sigEmax) were tested. gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression, stratification by sex 2) Multiple contrast test 3) Find best-fit dose-response model. sigEmax model analysis is shown here.||||0.0574
91693861|NCT04681066|183282894|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the hazard ratio obtained at each individual dose.|Hazard Ratio, log|0.4668||||0.0574|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model for high HCT based on all 3 dosage data points, not just the 2.0mg/kg point shown here.|Mixed Models Analysis|See Statistical Analysis 10 and 11 for the other two data points (0.5mg/kg and 1.0mg/kg) that are part of this same curve and p-value analysis.||The purpose of this analysis is to determine whether a dose-response relationship exists for the subset of patients with high HCT. Multiple possible models (Emax and sigEmax) were tested. gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis was performed in 3 steps as described in the SAP: 1) Hazard ratio (each dose vs placebo) using stratified Cox regression, stratification by sex 2) Multiple contrast test 3) Find best-fit dose-response model. sigEmax model analysis is shown here.||||0.0574
91705794|NCT06010732|183305915|SUPERIORITY||Ratio of Means|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.86||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(lesion depth)||0.86|0.69|<0.001
91693862|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-2.3604||||0.2379|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the Emax curve model based on all 4 dosage data points, not just the placebo data point shown here.|Mixed Models Analysis|See Statistical Analysis 2, 3, \& 4 for the other data points (0.5mg/kg, 1.0mg/kg, and 2.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.2379
91693863|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-2.5078||||0.2379|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the Emax curve model based on all 4 dosage data points, not just the 0.5mg/kg data point shown here.|Mixed Models Analysis|See Statistical Analysis 1, 3, \& 4 for the other data points (placebo, 1.0mg/kg, \& 2.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.2379
91693864|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-4.834||||0.2379|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the Emax curve model based on all 4 dosage data points, not just the 1.0mg/kg data point shown here.|Mixed Models Analysis|See Statistical Analysis 1, 2, \& 4 for the other data points (placebo, 0.5mg/kg, \& 2.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.2379
91693865|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-4.7657||||0.2379|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the Emax curve model based on all 4 dosage data points, not just the 2.0mg/kg data point shown here.|Mixed Models Analysis|See Statistical Analysis 1, 2, \& 3 for the other data points (placebo, 0.5mg/kg, \& 1.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.2379
91693866|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-2.3604||||0.0291|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model based on all 4 dosage data points, not just the placebo data point shown here.|Mixed Models Analysis|See Statistical Analysis 6, 7, \& 8 for the other data points (0.5mg/kg, 1.0mg/kg, and 2.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. SigEmax model analysis is shown here.||||0.0291
91723809|NCT00407511|183341118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.7|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).||-3.7|-4.7|< 0.0001
91489692|NCT01681472|182852175|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91705366|NCT01306214|183305229|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.48|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.63|-1.33||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|hypothesis test: H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo||-1.33|-3.63|<0.0001
91705795|NCT06010732|183305916|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.647|TWO_SIDED|95.0|-2.95|1.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||1.84|-2.95|0.647
91705796|NCT06010732|183305916|SUPERIORITY||Mean Difference (Final Values)|6.35|||<|0.001|TWO_SIDED|95.0|3.95|8.75||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||8.75|3.95|<0.001
91705797|NCT06010732|183305916|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|95.0|4.49|9.31||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||9.31|4.49|<0.001
91705798|NCT00253370|183305921|SUPERIORITY_OR_OTHER||proportion of participants|0.409||||0.0012|TWO_SIDED|90.0|0.284|0.544|||one-sample binomial test|||The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.||0.544|0.284|0.0012
91705799|NCT03725033|183305994|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.0028
91489693|NCT01681472|182852175|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
91489694|NCT01681472|182852175|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
91705800|NCT03725033|183305995|SUPERIORITY|||||||0.0805|||||||Fisher Exact|||||||0.0805
91705801|NCT03725033|183305996|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.99
91705802|NCT03725033|183305997|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.79
91705803|NCT05079230|183306070|SUPERIORITY||Hazard Ratio (HR)|1.178||||0.3276|TWO_SIDED|95.0|0.848|1.637|||stratified log-rank test|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.637|0.848|0.3276
91705804|NCT05079230|183306071|SUPERIORITY||Stratified Odds Ratio|0.826||||0.3616|TWO_SIDED|95.0|0.545|1.251|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.251|0.545|0.3616
91705805|NCT05079230|183306072|SUPERIORITY||Stratified Odds Ratio|0.856||||0.4679|TWO_SIDED|95.0|0.56|1.307|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.307|0.560|0.4679
91705806|NCT05079230|183306073|SUPERIORITY||Stratified Hazard Ratio|0.946||||0.7903|TWO_SIDED|95.0|0.73|1.225|||Stratified Log Rank||The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|||1.225|0.730|0.7903
91705807|NCT05079230|183306076|SUPERIORITY||Stratified Odds Ratio|1.189||||0.4873|TWO_SIDED|95.0|0.727|1.945|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.945|0.727|0.4873
91705808|NCT05079230|183306077|SUPERIORITY||Stratified Odds Ratio|1.154||||0.5842|TWO_SIDED|95.0|0.69|1.932|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.932|0.690|0.5842
91705809|NCT05079230|183306078|SUPERIORITY||Stratified Odds Ratio|0.783||||0.3003|TWO_SIDED|95.0|0.492|1.245|||Cochran-Mantel-Haenszel||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|||1.245|0.492|0.3003
91705810|NCT05079230|183306079|SUPERIORITY||Stratified Odds Ratio|1.21||||0.579|TWO_SIDED|95.0|0.62|2.36||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|Cochran-Mantel-Haenszel|||||2.360|0.620|0.5790
91705811|NCT05079230|183306080|SUPERIORITY||Stratified Hazard Ratio|1.09||||0.5796|TWO_SIDED|95.0|0.799|1.487|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI are calculated using the stratified cox proportional hazards model.|||1.487|0.799|0.5796
91705812|NCT05079230|183306081|SUPERIORITY||Stratified Hazard Ratio|1.271||||0.1026|TWO_SIDED|95.0|0.948|1.704|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.704|0.948|0.1026
91489695|NCT01681472|182852175|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
91693867|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-2.5078||||0.0291|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model based on all 4 dosage data points, not just the 0.5mg/kg data point shown here.|Mixed Models Analysis|See Statistical Analysis 5, 7, \& 8 for the other data points (placebo, 1.0mg/kg, \& 2.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. SigEmax model analysis is shown here.||||0.0291
91693868|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-4.834||||0.0291|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model based on all 4 dosage data points, not just the 1.0mg/kg data point shown here.|Mixed Models Analysis|See Statistical Analysis 5, 6, \& 8 for the other data points (placebo, 0.5mg/kg, \& 2.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. SigEmax model analysis is shown here.||||0.0291
91693869|NCT04681066|183282895|OTHER|The null hypothesis of flat dose-response relationship as compared to placebo for the primary efficacy endpoint was tested against the alternative hypothesis of a non-constant dose-response curve using a multiple contrast test as described in the gMCP-Mod methodology. The contrast test statistic is a linear combination of the optimal contrast coefficients corresponding to the dose-response curve model (Emax or sigEmax) with the logit of rate of severe respiratory failure at each individual dose.|Odds Ratio, log|-4.7657||||0.0291|TWO_SIDED|||||p-value adjusted for multiple comparisons. Test is based on significance level of one-sided 15%.The p-value shown here relates to fit of the sigEmax curve model based on all 4 dosage data points, not just the 2.0mg/kg data point shown here.|Mixed Models Analysis|See Statistical Analysis 5, 6, \& 7 for the other data points (placebo, 0.5mg/kg, \& 1.0mg/kg) that are part of this same curve and p-value analysis.||Analysis to determine whether a dose-response relationship exists. Multiple possible models (Emax and sigEmax) were tested using gMCP-Mod (Generalized Multiple Comparisons \& Modeling) analysis, performed in 3 steps as described in the SAP: 1) Odds ratio between each dose using logistic regression, with treatment, sex, and risk for organ failure (high/low HCT) as covariates 2) Multiple contrast test 3) Find best-fit dose-response model. Emax model analysis is shown here.||||0.0291
91693870|NCT04681066|183282906|SUPERIORITY|||||||0.0372|||||||Finkelstein-Schoenfeld|||||||0.0372
91693871|NCT04681066|183282906|SUPERIORITY|||||||0.4918|||||||Finkelstein-Schoenfeld|||||||0.4918
91693872|NCT04681066|183282906|SUPERIORITY|||||||0.6224|||||||Finkelstein-Schoenfeld|||||||0.6224
91693873|NCT03868930|183282965|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
91693874|NCT03868930|183282965|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
91705813|NCT01782352|183306104|SUPERIORITY||Hazard Ratio (HR)|1.02|||<|0.05|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox|||||1.27|0.82|<0.05
91705814|NCT01782352|183306104|SUPERIORITY||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.76|1.17|||Regression, Cox|||||1.17|0.76|<0.05
91705815|NCT01782352|183306105|SUPERIORITY||Hazard Ratio (HR)|1.21|||<|0.05|TWO_SIDED|95.0|0.86|1.7|||Regression, Cox|||||1.70|0.86|<0.05
91705816|NCT01782352|183306105|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox|||||1.17|0.59|<0.05
91705817|NCT01782352|183306106|SUPERIORITY||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.81|1.84|||Regression, Cox|||||1.84|0.81|<0.05
91705818|NCT01782352|183306106|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.05|TWO_SIDED|95.0|0.48|1.09|||Regression, Cox|||||1.09|0.48|<0.05
91489696|NCT01681472|182852176|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||1.0000
91705819|NCT01782352|183306107|SUPERIORITY||Hazard Ratio (HR)|1.09|||<|0.05|TWO_SIDED|95.0|0.86|1.37|||Regression, Cox|||||1.37|0.86|<0.05
91489697|NCT01681472|182852176|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693875|NCT03868930|183282965|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
91693876|NCT03868930|183282965|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
91693877|NCT03868930|183282966|SUPERIORITY|||||||0.0044||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0044
91693878|NCT03868930|183282966|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||<.0001
91693879|NCT03868930|183282966|SUPERIORITY|||||||0.0162||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0162
91693880|NCT03868930|183282966|SUPERIORITY|||||||0.0009||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0009
91693881|NCT03868930|183282967|SUPERIORITY|||||||0.014||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0140
91723810|NCT00407511|183341118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-5.1|-4.1|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= 78 days).||-4.1|-5.1|< 0.0001
91723811|NCT00407511|183341118|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
91723812|NCT00407511|183341119|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.2|-3.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).||-3.4|-4.2|< 0.0001
91723813|NCT00407511|183341119|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= Day 78)||-3.7|-4.5|< 0.0001
91723814|NCT00407511|183341119|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
91723815|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-22.3|-14.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.||-14.0|-22.3|< 0.0001
91723816|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.2|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-32.4|-24.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.||-24.0|-32.4|< 0.0001
91723817|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.3|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-38.5|-30.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.||-30.0|-38.5|< 0.0001
91489698|NCT01681472|182852176|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
91489699|NCT01681472|182852176|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91705820|NCT01782352|183306107|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.73|1.17|||Regression, Cox|||||1.17|0.73|<0.05
91705821|NCT01782352|183306108|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.05|TWO_SIDED|95.0|0.33|1.21|||Regression, Cox|||||1.21|0.33|<0.05
91705822|NCT01782352|183306108|SUPERIORITY||Hazard Ratio (HR)|1.05|||<|0.05|TWO_SIDED|95.0|0.56|1.97|||Regression, Cox|||||1.97|0.56|<0.05
91705823|NCT01782352|183306109|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.69|1.25|||Regression, Cox|||||1.25|0.69|<0.05
91705824|NCT01782352|183306109|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.67|1.21|||Regression, Cox|||||1.21|0.67|<0.05
91705825|NCT00477607|183306110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.89|TWO_SIDED|95.0|0.4|11.4|||Fisher Exact|No adjustments. Right one-sided p-value.||H0: pr(Hearing loss arm 1) = pr(Hearing loss arm 2)||11.4|0.4|0.89
91705826|NCT00477607|183306111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.195|STANDARD_ERROR_OF_MEAN|0.3999||0.63|TWO_SIDED|95.0|-1.03|0.64|||t-test, 2 sided|||H0: mean (MDA arm 1) = mean (MDA Arm 2)||0.64|-1.03|0.63
91705827|NCT00477607|183306112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.2|STANDARD_ERROR_OF_MEAN|32.7||0.15|TWO_SIDED|95.0|-18.1|114.6|||t-test, 2 sided|||H0: mean(max dose arm 1) = mean(max dose arm 2)||114.6|-18.1|0.15
91705828|NCT00432276|183306113|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.47|||||ONE_SIDED|97.5||-0.35|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.||-0.35||
91705829|NCT00432276|183306113|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.42|||||ONE_SIDED|97.5||-0.28|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Comparison of Change from Baseline at Week 52. The null hypothesis was that the average change from Baseline in HbA1c at Week 52 for the alogliptin 25 mg addition group is inferior to the average change for the pioglitazone titration group. The alternative hypothesis was that the change from Baseline in HbA1c for the alogliptin 25 mg addition group was non-inferior to the change for the pioglitazone titration group for at Week 52.||-0.28||
91705830|NCT00432276|183306114|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31||Statistical tests and resulting P-values are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.||Comparison of change from Baseline in HbA1c at Week 42.||-0.31|-0.57|<0.001
91705831|NCT00432276|183306122|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-16.2|-5.7||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and FPG as covariates.||Comparison of change from Baseline at Week 52.||-5.7|-16.2|<0.001
91705832|NCT00432276|183306123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of marked hyperglycemia through Week 52.||||<0.001
91705833|NCT00432276|183306124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of hyperglycemic rescue through Week 52.||||<0.001
91705834|NCT00432276|183306125|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.116|TWO_SIDED|95.0|-3.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and proinsulin as covariates.||Comparison of change from Baseline at Week 52.||0.4|-3.7|0.116
91705835|NCT00432276|183306126|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.276|TWO_SIDED|95.0|-0.58|2.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and fasting insulin as covariates.||Comparison of change from Baseline at Week 52.||2.04|-0.58|0.276
91705836|NCT00432276|183306127|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.041|||<|0.001|TWO_SIDED|95.0|-0.063|-0.018||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as covariates.||Comparison of change from Baseline at Week 52.||-0.018|-0.063|<0.001
91705837|NCT00432276|183306128|SUPERIORITY_OR_OTHER||LS Mean Difference|0.073||||0.23|TWO_SIDED|95.0|-0.047|0.193||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.||Comparison of change from Baseline at Week 52.||0.193|-0.047|0.230
91705838|NCT00432276|183306129|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188||||0.567|TWO_SIDED|95.0|-0.83|0.455||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates.||Comparison of change from Baseline at Week 52.||0.455|-0.830|0.567
91693882|NCT03868930|183282967|SUPERIORITY|||||||0.1548||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.1548
91693883|NCT03868930|183282967|SUPERIORITY|||||||0.0302||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0302
91693884|NCT03868930|183282967|SUPERIORITY|||||||0.0158||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0158
91693885|NCT03868930|183282967|SUPERIORITY|||||||0.0034||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0034
91693886|NCT03868930|183282967|SUPERIORITY|||||||0.8776||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.8776
91693887|NCT03868930|183282967|SUPERIORITY|||||||0.0002||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0002
91693888|NCT03868930|183282967|SUPERIORITY|||||||0.0198||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0198
91693889|NCT03868930|183282967|SUPERIORITY|||||||0.0013||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0013
91693890|NCT03868930|183282967|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy Group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
91693891|NCT03868930|183282967|SUPERIORITY|||||||0.0345||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||.0345
91693892|NCT03868930|183282967|SUPERIORITY|||||||0.5918||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.5918
91693893|NCT06047366|183282980|OTHER|||||||0.18||||||p \< 0.05 was used as the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.18
91693894|NCT06047366|183282981|OTHER|||||||0.09||||||p \< 0.05 was used as the threshold for statistical significance|Log Rank|||||||0.09
91693895|NCT02151851|183282982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.899|||<|0.001|TWO_SIDED|95.0|2.382|6.382||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||6.382|2.382|<0.001
91693896|NCT02151851|183282983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.641|||<|0.001|TWO_SIDED|95.0|3.57|16.352||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||16.352|3.570|<0.001
91693897|NCT02151851|183282984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.248|||<|0.001|TWO_SIDED|95.0|2.209|23.786||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||23.786|2.209|<0.001
91693898|NCT02640950|183282996|SUPERIORITY||||||<|0.001||||||Paired t test for pre and post treatment scores for all subjects|t-test, 2 sided|||Paired t-test of pre and post treatment scores on MADRS||||<0.001
91693899|NCT02640950|183282997|OTHER|Descriptive Frequencies Analysis|||||||||||||||||A frequencies analysis was conducted to determine the number of participants that were diagnosed with BP I and BP II as well as the number of participants that developed an onset of maniac symptoms during the 7 week treatment period.|||
91693900|NCT00652626|183283011|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|98.4|||||TWO_SIDED|90.0|64.0|151.3|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% confidence interval (CI) of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||151.3|64.0|
91489700|NCT01681472|182852176|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0005
91693901|NCT00652626|183283011|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|67.5|||||TWO_SIDED|90.0|44.7|101.8|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||101.8|44.7|
91693902|NCT00652626|183283011|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|82.7|||||TWO_SIDED|90.0|53.8|127.2|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||127.2|53.8|
91693903|NCT00652626|183283012|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|97.4|||||TWO_SIDED|90.0|63.8|148.8|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||148.8|63.8|
91693904|NCT00652626|183283012|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|68.5|||||TWO_SIDED|90.0|45.7|102.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||102.7|45.7|
91693905|NCT00652626|183283012|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|83.2|||||TWO_SIDED|90.0|54.5|127.1|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||127.1|54.5|
91693906|NCT00652626|183283013|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|127.7|||||TWO_SIDED|90.0|66.3|245.7|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||245.7|66.3|
91693907|NCT00652626|183283013|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|84.7|||||TWO_SIDED|90.0|45.3|158.5|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||158.5|45.3|
91693908|NCT00652626|183283013|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|107.5|||||TWO_SIDED|90.0|55.9|207.0|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||207.0|55.9|
91693909|NCT00652626|183283016|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.1|||||TWO_SIDED|90.0|71.2|143.6|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.6|71.2|
91723818|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.9|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-45.2|-36.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.||-36.7|-45.2|< 0.0001
91723819|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-50.2|-41.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.||-41.4|-50.2|< 0.0001
91723820|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.4|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-52.8|-44.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell \>= Day 78.||-44.0|-52.8|< 0.0001
91723821|NCT00407511|183341122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
91723822|NCT00407511|183341123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-43.4|-33.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.||-33.9|-43.4|< 0.0001
91489701|NCT01681472|182852176|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91693910|NCT00652626|183283016|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|144.9|||||TWO_SIDED|90.0|103.6|202.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||202.7|103.6|
91693911|NCT00652626|183283016|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.4|||||TWO_SIDED|90.0|71.4|143.9|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.9|71.4|
91693912|NCT00652626|183283019|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|169.3|||||TWO_SIDED|90.0|109.2|262.5|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters"||262.5|109.2|
91693913|NCT00652626|183283019|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|140.4|||||TWO_SIDED|90.0|90.6|217.7|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||217.7|90.6|
91693914|NCT00652626|183283020|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|166.3|||||TWO_SIDED|90.0|108.6|254.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||254.6|108.6|
91693915|NCT00652626|183283020|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.2|||||TWO_SIDED|90.0|92.2|216.2|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||216.2|92.2|
91693916|NCT00652626|183283021|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.7|||||TWO_SIDED|90.0|73.2|274.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||274.6|73.2|
91693917|NCT00652626|183283021|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|105.6|||||TWO_SIDED|90.0|54.5|204.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||204.6|54.5|
91693918|NCT00652626|183283022|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1342|TWO_SIDED|90.0|0.0|0.52|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.||0.52|0|0.1342
91693919|NCT00652626|183283022|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1017|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.||0.50|0|0.1017
91693920|NCT04003636|183283027|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0034|TWO_SIDED|95.0|0.72|0.95|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||0.95|0.72|0.0034
91693921|NCT04003636|183283028|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0225|TWO_SIDED|95.0|0.75|1.0|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||1.00|0.75|0.0225
91693922|NCT04003636|183283029|SUPERIORITY||Difference in Percentages|0.2||||0.4735|TWO_SIDED|95.0|-5.2|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0|Miettinen & Nurminen||Difference=Arm A minus Arm B|||5.6|-5.2|0.4735
91693923|NCT00915018|183283037|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.8934|TWO_SIDED|95.0|0.813|1.269|||Log Rank|||||1.269|0.813|0.8934
91527983|NCT00574990|182930976|SUPERIORITY_OR_OTHER||chi square|12.99|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|||||Differences between roles and communication event content were assessed by Chi squared|Chi-squared|||Descriptive counts and chi squared were done on the observation data.||||0.01
91693924|NCT00915018|183283038|OTHER||Risk Difference (RD)|0.028||||0.5219|TWO_SIDED|95.0|-0.048|0.105|||Mantel Haenszel|||||0.105|-0.048|0.5219
91693925|NCT00915018|183283039|OTHER||Hazard Ratio (HR)|0.974||||0.8431|TWO_SIDED|95.0|0.752|1.262|||Log Rank|||||1.262|0.752|0.8431
91693926|NCT00915018|183283040|OTHER||Risk Difference (RD)|-0.032||||0.236|TWO_SIDED|95.0|-0.093|0.029|||Mantel Haenszel|||||0.029|-0.093|0.2360
91693927|NCT00915018|183283041|OTHER||Hazard Ratio (HR)|0.449||||0.0036|TWO_SIDED|95.0|0.259|0.78|||Log Rank|||||0.780|0.259|0.0036
91693928|NCT00300885|183283042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.915||95.0|0.94|1.41||According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.|Log Rank||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta\>=1, Alternative: theta\<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.||1.41|0.94|0.915
91693929|NCT00300885|183283043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.433||95.0|0.84|1.16|||Log Rank|||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with alpha of 0.025 stratified by same stratification factors at randomization||1.16|0.84|0.433
91693930|NCT00300885|183283044|SUPERIORITY_OR_OTHER||difference in response rate (CR+PR rate)|-3.65||||0.1015||95.0|-9.18|1.89||no adjustments|Cochran-Mantel-Haenszel||difference in response rates (Complete Response (CR) + Partial Response (PR)) = Placebo+C/P - Sorafenib+C/P|Objective response rate (ie. CR+PR rate) was compared between treatment arms using Cochran-Mantel-Haenszel test with one-side alpha 0.025 adjusting for same stratification factors as randomization||1.89|-9.18|0.1015
91693931|NCT02582242|183283048|OTHER||Treatment difference at week 24|-0.09||||0.2601|TWO_SIDED|95.0|-0.23|0.06|||Mixed model for repeated measurements||Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID).|The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.06|-0.23|0.2601
91693932|NCT00603902|183283077|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|2.69|||<|0.0001|TWO_SIDED|95.0|2.31|3.13|||Regression, Logistic|Adjustments for baseline body weight.||||3.13|2.31|<0.0001
91693933|NCT00603902|183283078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.44|-2.56|||ANCOVA|||||-2.56|-3.44|<0.0001
91693934|NCT02282631|183283093|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|"U=390.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."||||||0.02
91693935|NCT02282631|183283094|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=665.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
91693936|NCT02282631|183283095|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=596.5 Z=-2.4 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
91693937|NCT02282631|183283096|SUPERIORITY_OR_OTHER|||||||0.01||||||"U=955.0 Z=-2.5 p=0.01~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.01
91693938|NCT02453334|183283099|OTHER||Odds Ratio (OR)|0.51||||0.0143|TWO_SIDED|95.0|0.3|0.87|||Cochran-Mantel-Haenszel|||||0.87|0.30|0.0143
91693939|NCT02453334|183283099|OTHER||Percentage difference|-15.6|||||TWO_SIDED|95.0|-28.01|-3.1||||||||-3.10|-28.01|
91693940|NCT02453334|183283101|OTHER||Odds Ratio (OR)|2.04||||0.0097|TWO_SIDED|95.0|1.19|3.5|||Cochran-Mantel-Haenszel|||||3.50|1.19|0.0097
91693941|NCT02453334|183283101|OTHER||Percentage difference|16.4|||||TWO_SIDED|95.0|4.19|28.51||||||Percentage difference||28.51|4.19|
91693942|NCT02453334|183283102|OTHER||Percentage difference|-2.7|||||TWO_SIDED|95.0|-12.85|7.45||||||||7.45|-12.85|
91527984|NCT01381874|182930992|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.437|TWO_SIDED|95.0|0.816|1.603|||stratified log-rank test|||||1.603|0.816|0.437
91693943|NCT02453334|183283102|OTHER||Odds Ratio (OR)|0.83||||0.5758|TWO_SIDED|95.0|0.43|1.6|||Cochran-Mantel-Haenszel|||Placebo group was used as the denominator for odds ratio calculation.||1.60|0.43|0.5758
91693944|NCT02453334|183283103|OTHER||Odds Ratio (OR)|1.4||||0.2772|TWO_SIDED|95.0|0.76|2.56||Placebo group was used as the denominator for odds ratio calculation|Cochran-Mantel-Haenszel|||||2.56|0.76|0.2772
91693945|NCT02453334|183283103|OTHER||Percentage difference|5.7|||||TWO_SIDED|95.0|-5.01|16.43||||||||16.43|-5.01|
91693946|NCT02453334|183283104|OTHER|||||||0.0011|||||||Log Rank|P-value was estimated using logrank test stratified by country||||||0.0011
91723823|NCT00407511|183341123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-45.5|-35.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell \>=Day 78.||-35.9|-45.5|< 0.0001
91723824|NCT00407511|183341123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
91693947|NCT02453334|183283105|OTHER||Percentage difference|0.7|||||TWO_SIDED|95.0|-7.6|9.08||||||||9.08|-7.60|
91693948|NCT02453334|183283105|OTHER||Odds Ratio (OR)|1.05||||0.8924|TWO_SIDED|95.0|0.49|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.49|0.8924
91693949|NCT02453334|183283106|OTHER||Percentage difference|-9.8|||||TWO_SIDED|95.0|-20.41|0.77||||||||0.77|-20.41|
91693950|NCT02453334|183283106|OTHER||Odds Ratio (OR)|0.55||||0.074|TWO_SIDED|95.0|0.28|1.06|||Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.||1.06|0.28|0.0740
91693951|NCT02453334|183283107|OTHER||Percentage difference|-12.1|||||TWO_SIDED|95.0|-23.31|-0.91||||||||-0.91|-23.31|
91693952|NCT02453334|183283107|OTHER||Odds Ratio (OR)|0.51||||0.0446|TWO_SIDED|95.0|0.26|0.99||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation||||0.99|0.26|0.0446
91693953|NCT02453334|183283108|OTHER||Percentage difference|-19.8|||||TWO_SIDED|95.0|-30.9|-8.69||||||||-8.69|-30.90|
91693954|NCT02453334|183283108|OTHER||Odds Ratio (OR)|0.3||||0.001|TWO_SIDED|95.0|0.14|0.63||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||||0.63|0.14|0.0010
91693955|NCT02453334|183283109|OTHER||Percentage difference|-21.4|||||TWO_SIDED|95.0|-33.22|-9.51||||||||-9.51|-33.22|
91693956|NCT02453334|183283109|OTHER||Odds Ratio (OR)|0.29||||0.0009|TWO_SIDED|95.0|0.13|0.61||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.61|0.13|0.0009
91693957|NCT02453334|183283110|OTHER||Percentage difference|-16.0|||||TWO_SIDED|95.0|-27.73|-4.26||||||||-4.26|-27.73|
91693958|NCT02453334|183283110|OTHER||Odds Ratio (OR)|0.34||||0.0093|TWO_SIDED|95.0|0.14|0.79||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.79|0.14|0.0093
91693959|NCT02453334|183283111|OTHER||Percentage difference|-4.4|||||TWO_SIDED|95.0|-15.37|6.57||||||||6.57|-15.37|
91693960|NCT02453334|183283111|OTHER||Odds Ratio (OR)|0.7||||0.4786|TWO_SIDED|95.0|0.26|1.89||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.89|0.26|0.4786
91693961|NCT02453334|183283112|OTHER||Percentage difference|-7.4|||||TWO_SIDED|95.0|-19.25|4.55||||||||4.55|-19.25|
91693962|NCT02453334|183283112|OTHER||Odds Ratio (OR)|0.54||||0.2084|TWO_SIDED|95.0|0.2|1.43||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.43|0.20|0.2084
91693963|NCT02453334|183283113|OTHER||Percentage difference|3.1|||||TWO_SIDED|95.0|-9.33|15.54||||||||15.54|-9.33|
91693964|NCT02453334|183283113|OTHER||Odds Ratio (OR)|1.25||||0.6508|TWO_SIDED|95.0|0.48|3.24|||Cochran-Mantel-Haenszel|The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Placebo group was used as the denominator for odds ratio calculation.|||3.24|0.48|0.6508
91693965|NCT02453334|183283115|OTHER|||||||0.0063||||||P-value was estimated using logrank test stratified by pooled sites.|Log Rank|||||||0.0063
91693966|NCT02362672|183283123|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0019|TWO_SIDED||||||z-test|||NKTR-181 (Double-blind Treatment Phase), Placebo (Double-blind Treatment Phase)||||0.0019
91693967|NCT00693498|183283130|OTHER||||||<|0.03||||||the reported value is for POD#1 assessment|Wald Wolfowitz|||||||<0.03
91693968|NCT00693498|183283130|OTHER|||||||0.29||||||for POD#2 assessment|Wald-Wolf|||||||0.29
91693969|NCT05483686|183283131|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||This analysis aims to detect a significant change (p = .05) in percentage of participants with HIV transmission risk between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.19
91723825|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.4|-0.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-0.7|-1.4|< 0.0001
91723826|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.2|-1.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-1.5|-2.2|< 0.0001
91723827|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.9|-2.2|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.2|-2.9|< 0.0001
91723828|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.2|-2.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.5|-3.2|< 0.0001
91723829|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.3|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.3|< 0.0001
91527985|NCT01381874|182930992|SUPERIORITY||Hazard Ratio (HR)|0.958||||0.794|TWO_SIDED|95.0|0.695|1.32|||stratified log-rank test|||||1.320|0.695|0.794
91527986|NCT01381874|182930993|SUPERIORITY||Hazard Ratio (HR)|1.074||||0.807|TWO_SIDED|95.0|0.608|1.896|||stratified log-rank test|||||1.896|0.608|0.807
91693970|NCT05483686|183283132|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in ART adherence between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||=.24
91693971|NCT05483686|183283133|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.79
91693972|NCT05483686|183283134|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to ART use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
91693973|NCT05483686|183283135|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to PrEP use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.14
91693974|NCT05483686|183283136|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
91693975|NCT05483686|183283137|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in social support between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.30
91693976|NCT05483686|183283138|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in gender identity comfort between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.94
91527987|NCT01381874|182930993|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.542|TWO_SIDED|95.0|0.688|2.036|||stratified log-rank test|||||2.036|0.688|0.542
91693977|NCT01369030|183283192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|6.3||0|||||||Wilcoxon signed-rank test|||||||0.000
91693978|NCT06152224|183283195|EQUIVALENCE|"Power analysis was determined based on a 4.3 point improvement on the Vaizey score in both groups.~With an allowable difference of 1 point between randomized groups, standard deviation = 3, margin = 4.3, power = 0.8, alpha = 0.05, attrition = 25 percent."|Mean Difference (Final Values)|-4.3|STANDARD_DEVIATION|3.0||0.918|TWO_SIDED|||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.918
91693979|NCT06152224|183283200|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.801||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.801
91723830|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.4|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.4|< 0.0001
91723831|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.5|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.5|< 0.0001
91527988|NCT01381874|182930994|SUPERIORITY||Risk Ratio (RR)|0.909||||1|TWO_SIDED|95.0|0.213|3.878|||Fisher Exact|||||3.878|0.213|1.000
91527989|NCT01381874|182930994|SUPERIORITY||Risk Ratio (RR)|1.909||||0.366|TWO_SIDED|95.0|0.605|6.026|||Fisher Exact|||||6.026|0.605|0.366
91527990|NCT01381874|182930995|SUPERIORITY||Risk Ratio (RR)|0.757||||0.603|TWO_SIDED|95.0|0.264|2.175|||Chi-squared|||||2.175|0.264|0.603
91527991|NCT01381874|182930995|SUPERIORITY||Risk Ratio (RR)|1.79||||0.137|TWO_SIDED|95.0|0.816|3.926|||Chi-squared|||||3.926|0.816|0.137
91527992|NCT00114634|182931017|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
91693980|NCT06152224|183283200|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.317||||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.317
91693981|NCT06152224|183283201|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline Brink Score: Pressure||||<0.001
91693982|NCT06152224|183283201|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Pressure||||<0.001
91693983|NCT06152224|183283202|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Change from baseline in Brink Score: Vertical Displacement||||<0.001
91693984|NCT06152224|183283202|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Vertical Displacement||||<0.001
91693985|NCT06152224|183283203|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
91693986|NCT06152224|183283203|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
91693987|NCT06152224|183283213|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.035||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q1. The app was easy to use||||0.035
91693988|NCT06152224|183283213|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.063||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q2. It was easy for me to learn to use the app||||0.063
91693989|NCT06152224|183283213|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.587||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q11. I would use this app again||||0.587
91693990|NCT06152224|183283213|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.107||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q12. Overall, I am satisfied with this app||||0.107
91723832|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.6|< 0.0001
91723833|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-2.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.9|-3.7|< 0.0001
91723834|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
91723835|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.8|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.8|< 0.0001
91723836|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
91723837|NCT00407511|183341124|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.||||< 0.0001
91723838|NCT01047501|183341136|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-21.5|||<|0.0001|TWO_SIDED|95.0|-26.7|-16.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-16.2|-26.7|<0.0001
91723839|NCT01047501|183341136|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.1||||0.0005|TWO_SIDED|95.0|-15.7|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-15.7|0.0005
91723840|NCT01047501|183341137|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-6.2||||0.0067|TWO_SIDED|95.0|-10.5|-1.7|||Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-1.7|-10.5|0.0067
91723841|NCT01047501|183341137|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-3.6||||0.0867|TWO_SIDED|95.0|-7.9|0.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||0.5|-7.9|0.0867
91723842|NCT01047501|183341138|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0001|TWO_SIDED|95.0|-17.2|-9.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-9.9|-17.2|0.0001
91723843|NCT01047501|183341138|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.5||||0.014|TWO_SIDED|95.0|-9.4|-1.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.7|-9.4|0.0140
91723844|NCT01047501|183341139|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-24.4||||0.0001|TWO_SIDED|95.0|-31.9|-17.0||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-17.0|-31.9|0.0001
91723845|NCT01047501|183341139|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.5||||0.017|TWO_SIDED|95.0|-18.3|-2.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-2.5|-18.3|0.0170
91723846|NCT01047501|183341140|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.0||||0.0001|TWO_SIDED|95.0|-22.2|-15.7||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-15.7|-22.2|0.0001
91723847|NCT01047501|183341140|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.0||||0.0004|TWO_SIDED|95.0|-11.6|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-11.6|0.0004
91759983|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.34|||||TWO_SIDED|95.0|-20.56|-2.13||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.13|-20.56|
91527993|NCT02223065|182931023|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.975||||0.495|TWO_SIDED|90.0|0.915|1.038|||ANOVA|||||1.038|0.915|0.4950
91527994|NCT02223065|182931024|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.993||||0.865|TWO_SIDED|90.0|0.932|1.06|||ANOVA|||||1.060|0.932|0.8650
91527995|NCT02223065|182931025|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.022||||0.2344|TWO_SIDED|90.0|0.991|1.054|||ANOVA|||||1.054|0.991|0.2344
91693991|NCT06152224|183283213|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.486||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q15. The app helped me manage my health effectively||||0.486
91693992|NCT03126630|183283218|EQUIVALENCE|The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.||||||0.27541|||||||Chi-squared|||||||0.27541
91693993|NCT03126630|183283221|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.1936|TWO_SIDED|95.0|0.0||Not enough events||Log Rank||||||0.0|0.1936
91693994|NCT03126630|183283222|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.1952|TWO_SIDED|95.0|0.73|4.51|||Log Rank|||||4.51|0.73|0.1952
91693995|NCT06028438|183283227|SUPERIORITY||Least square mean difference|-0.06|||=|0.822|TWO_SIDED|95.0|-0.6|0.48|||ANCOVA|||||0.48|-0.60|=0.822
91693996|NCT03150719|183283259|SUPERIORITY||Mean Difference|2.7|||||TWO_SIDED|95.0|1.0|4.4||||||||4.4|1.0|
91693997|NCT03150719|183283260|SUPERIORITY||Mean Difference|6.7|||||TWO_SIDED|95.0|2.5|10.9||||||||10.9|2.5|
91693998|NCT03150719|183283261|SUPERIORITY||Mean Difference|1.1|||||TWO_SIDED|95.0|-4.9|7.0||||||||7.0|-4.9|
91693999|NCT01050582|183283319|SUPERIORITY_OR_OTHER||Slope|0.447|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|0.22|0.674|||Regression, Linear|Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.||0.674|0.220|<0.001
91694000|NCT01050582|183283320|SUPERIORITY_OR_OTHER||Slope|-0.221|STANDARD_ERROR_OF_MEAN|0.25||0.378|TWO_SIDED|95.0|-0.711|0.269|||Regression, Linear|Covariates: Tanner stage and gender|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.|The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.||0.269|-0.711|0.378
91694001|NCT01050582|183283321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865|||>|0.999||95.0|0.189|3.963|||Fisher Exact||Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events||3.963|0.189|>0.999
91694002|NCT01019694|183283322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.02|13.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||13.19|6.02|< 0.0001
91694003|NCT01019694|183283322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.0009||95.0|2.57|9.91|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||9.91|2.57|0.0009
91694004|NCT01019694|183283323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.0006||95.0|2.29|8.28|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||8.28|2.29|0.0006
91694005|NCT01019694|183283323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.0001||95.0|4.41|10.39|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.39|4.41|< 0.0001
91694006|NCT01019694|183283324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|4.71|11.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||11.09|4.71|< 0.0001
91694007|NCT01019694|183283324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.44|12.83|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||12.83|6.44|< 0.0001
91694008|NCT01019694|183283325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|||<|0.0001||95.0|5.94|12.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||12.37|5.94|< 0.0001
91694009|NCT01019694|183283325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.44|10.96|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.96|4.44|< 0.0001
91694010|NCT01019694|183283326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|||<|0.0001||95.0|7.9|14.76|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||14.76|7.90|< 0.0001
91694011|NCT01019694|183283326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.23|11.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||11.23|4.23|< 0.0001
91694012|NCT01019694|183283328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1167||95.0|-0.05|0.42|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.42|-0.05|0.1167
91694013|NCT01019694|183283328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0026||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|0.13|0.0026
91694014|NCT01019694|183283329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.2826||95.0|-0.11|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.38|-0.11|0.2826
91694015|NCT01019694|183283329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0013||95.0|0.16|0.66|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.66|0.16|0.0013
91489702|NCT01681472|182852177|SUPERIORITY|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0056
91694016|NCT01019694|183283330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0023||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.59|0.13|0.0023
91694017|NCT01019694|183283330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.0001||95.0|0.25|0.71|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.71|0.25|< 0.0001
91694018|NCT01019694|183283331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0006||95.0|0.18|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.65|0.18|0.0006
91694019|NCT01019694|183283331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0004||95.0|0.2|0.68|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.68|0.20|0.0004
91694020|NCT01019694|183283332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0673||95.0|-0.02|0.47|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.47|-0.02|0.0673
91694021|NCT01019694|183283332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0245||95.0|0.04|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.54|0.04|0.0245
91694022|NCT01019694|183283334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.5695||95.0|-0.24|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.24|0.5695
91694023|NCT01019694|183283334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3093||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3093
91694024|NCT01019694|183283335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3578||95.0|-0.31|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.11|-0.31|0.3578
91694025|NCT01019694|183283335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7433||95.0|-0.18|0.25|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.25|-0.18|0.7433
91694026|NCT01019694|183283336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.524||95.0|-0.29|0.15|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.15|-0.29|0.524
91694027|NCT01019694|183283336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3171||95.0|-0.34|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.34|0.3171
91694028|NCT01019694|183283337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2499||95.0|-0.38|0.1|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.10|-0.38|0.2499
91694029|NCT01019694|183283337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6144||95.0|-0.31|0.18|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.18|-0.31|0.6144
91694030|NCT01019694|183283338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5142||95.0|-0.16|0.33|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.33|-0.16|0.5142
91694031|NCT01019694|183283338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2691||95.0|-0.39|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.39|0.2691
91489703|NCT01681472|182852177|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91694032|NCT01019694|183283340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6236||95.0|-0.23|0.14|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.14|-0.23|0.6236
91694033|NCT01019694|183283340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3342||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3342
91694034|NCT01019694|183283341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1884||95.0|-0.36|0.07|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.07|-0.36|0.1884
91694035|NCT01019694|183283341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6978||95.0|-0.17|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.26|-0.17|0.6978
91694036|NCT01019694|183283342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4197||95.0|-0.32|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.32|0.4197
91694037|NCT01019694|183283342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3949||95.0|-0.33|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.13|-0.33|0.3949
91694038|NCT01019694|183283343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.299||95.0|-0.38|0.12|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.12|-0.38|0.299
91489704|NCT01681472|182852177|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
91489705|NCT01681472|182852177|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91694039|NCT01019694|183283343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1404||95.0|-0.44|0.06|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.06|-0.44|0.1404
91694040|NCT01019694|183283344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.463||95.0|-0.36|0.16|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.16|-0.36|0.463
91694041|NCT01019694|183283344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.3824||95.0|-0.15|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.38|-0.15|0.3824
91694042|NCT01019694|183283345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8282||95.0|-0.036|0.045|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.045|-0.036|0.8282
91694043|NCT01019694|183283345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.6587||95.0|-0.032|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.032|0.6587
91694044|NCT01019694|183283346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1185||95.0|-0.009|0.081|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.081|-0.009|0.1185
91694045|NCT01019694|183283346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2651||95.0|-0.02|0.072|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.072|-0.020|0.2651
91694046|NCT01019694|183283347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5852||95.0|-0.058|0.033|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.033|-0.058|0.5852
91694047|NCT01019694|183283347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7242||95.0|-0.054|0.038|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.038|-0.054|0.7242
91694048|NCT01019694|183283348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0328||95.0|0.005|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||||0.110|0.005|0.0328
91694049|NCT01019694|183283348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8896||95.0|-0.058|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.058|0.8896
91694050|NCT01019694|183283349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.402||95.0|-0.042|0.105|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.105|-0.042|0.402
91694051|NCT01019694|183283349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.659||95.0|-0.057|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.090|-0.057|0.659
91694052|NCT01019694|183283350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0893||95.0|-0.01|0.139|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.139|-0.010|0.0893
91723848|NCT01047501|183341141|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-12.3|-6.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.1|-12.3|0.0001
91723849|NCT01047501|183341141|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-3.8||||0.017|TWO_SIDED|95.0|-6.9|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-6.9|0.0170
91694053|NCT01019694|183283350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.5424||95.0|-0.052|0.099|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.099|-0.052|0.5424
91694054|NCT01019694|183283351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6396||95.0|-0.104|0.064|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.064|-0.104|0.6396
91694055|NCT01019694|183283351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6455||95.0|-0.106|0.066|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.066|-0.106|0.6455
91723850|NCT05561140|183341182|SUPERIORITY||Difference in percentage|-0.3|||=|1|TWO_SIDED|95.0|-10.9|10.2|||Cochran-Mantel-Haenszel|||||10.2|-10.9|=1.0000
91527996|NCT02223065|182931026|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.016||||0.2458|TWO_SIDED|90.0|0.993|1.038|||ANOVA|||||1.038|0.993|0.2458
91694056|NCT01019694|183283352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.2596||95.0|-0.038|0.141|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.141|-0.038|0.2596
91723851|NCT05561140|183341184|SUPERIORITY||Least Square (LS) Mean Difference|-8.2|||=|0.0297|TWO_SIDED|95.0|-15.6|-0.8|||Mixed Models Analysis|||The mixed model for repeated measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for stratification factors.||-0.8|-15.6|=0.0297
91694057|NCT01019694|183283352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6659||95.0|-0.112|0.071|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.071|-0.112|0.6659
91694058|NCT01019694|183283354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.476||95.0|-0.4|0.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.19|-0.40|0.476
91694059|NCT01019694|183283354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6976||95.0|-0.35|0.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.23|-0.35|0.6976
91694060|NCT01019694|183283355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9506||95.0|-0.4|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.40|0.9506
91694061|NCT01019694|183283355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2362||95.0|-0.15|0.62|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.62|-0.15|0.2362
91694062|NCT01019694|183283356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5645||95.0|-0.3|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.54|-0.30|0.5645
91694063|NCT01019694|183283356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.0163||95.0|0.1|0.95|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.95|0.10|0.0163
91694064|NCT01019694|183283357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4339||95.0|-0.6|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.26|-0.60|0.4339
91694065|NCT01019694|183283357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4886||95.0|-0.28|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|-0.28|0.4886
91694066|NCT01019694|183283358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7637||95.0|-0.5|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.50|0.7637
91694067|NCT01019694|183283358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.3755||95.0|-0.24|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.65|-0.24|0.3755
91694068|NCT00463047|183283367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.18|0.29|||Mixed effects ANOVA|Crossover analysis||The statistical hypothesis to be tested was:HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and oxycodone (OXY), respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.29|0.18|<0.0001
91694069|NCT00463047|183283368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.0081|TWO_SIDED|95.0|0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.05|0.01|0.0081
91694070|NCT00463047|183283369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.05|0.13||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.13|0.05|<0.0001
91694071|NCT00463047|183283370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|0.3|0.45||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.45|0.30|<0.0001
91489706|NCT01681472|182852177|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
91705839|NCT00432276|183306130|SUPERIORITY_OR_OTHER||LS Mean Difference|12.963|||<|0.001|TWO_SIDED|95.0|5.333|20.592||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates.||Comparison of change from Baseline at Week 52.||20.592|5.333|<0.001
91694072|NCT00463047|183283371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.2|0.35||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.35|0.20|<0.0001
91694073|NCT00463047|183283372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|0.08|0.25||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.25|0.08|<0.0001
91694074|NCT00463047|183283379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|0.39|0.58|||ANOVA|||||0.58|0.39|<0.0001
91694075|NCT00463047|183283380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|0.7|1.16|||ANOVA|||||1.16|0.70|<0.0001
91694076|NCT00463047|183283381|SUPERIORITY_OR_OTHER|||||||0.1966||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.1966
91694077|NCT00463047|183283382|SUPERIORITY_OR_OTHER|||||||0.0275||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0275
91694078|NCT00463047|183283383|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
91694079|NCT00463047|183283384|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||<0.0001
91694080|NCT00463047|183283385|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
91694081|NCT00463047|183283386|SUPERIORITY_OR_OTHER|||||||0.0074||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0074
91694082|NCT00463047|183283387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|0.55|0.83||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.83|0.55|<0.0001
91694083|NCT00463047|183283389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5054||||0.3022|TWO_SIDED|95.0|0.7|3.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||3.3|0.7|0.3022
91694084|NCT00463047|183283390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4042||||0.0268|TWO_SIDED|95.0|1.0|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.0|0.0268
91694085|NCT00463047|183283391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4631||||0.0008|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0008
91694086|NCT00463047|183283392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3184||||0.0084|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0084
91694087|NCT00463047|183283393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0788||||0.5283|TWO_SIDED|95.0|0.9|1.4|||Generalize estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.5283
91694088|NCT00463047|183283394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9491||||0.711|TWO_SIDED|95.0|0.7|1.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.3|0.7|0.7110
91694089|NCT00463047|183283395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5355||||0.3288|TWO_SIDED|95.0|0.2|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.2|0.3288
91694090|NCT00463047|183283396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1485||||0.5145|TWO_SIDED|95.0|0.8|1.7|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.7|0.8|0.5145
91723852|NCT05561140|183341185|SUPERIORITY||Difference in percentage|-8.1|||=|0.3456|TWO_SIDED|95.0|-26.9|10.7|||Cochran-Mantel-Haenszel|||||10.7|-26.9|=0.3456
91489707|NCT01681472|182852177|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91527997|NCT02223065|182931027|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.024||||0.1947|TWO_SIDED|90.0|0.993|1.056|||ANOVA|||||1.056|0.993|0.1947
91723853|NCT00221104|183341186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8234|TWO_SIDED|95.0|0.73|1.29|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.29|0.73|0.8234
91723854|NCT00221104|183341187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.0047|TWO_SIDED|95.0|0.15|0.74|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||0.74|0.15|0.0047
91723855|NCT00221104|183341188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.3075|TWO_SIDED|95.0|0.81|1.91|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.91|0.81|0.3075
91723856|NCT00221104|183341189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.1986|TWO_SIDED|95.0|0.61|9.14|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||9.14|0.61|0.1986
91723857|NCT00221104|183341190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9953|TWO_SIDED|95.0|0.45|2.22|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||2.22|0.45|0.9953
91723858|NCT02989389|183341197|SUPERIORITY||Mean Difference (Final Values)|-11.57||||0.215|TWO_SIDED|90.0|-29.52|10.96|||Mixed Models Analysis|||Aβ 1-40||10.96|-29.52|0.215
91723859|NCT02989389|183341197|SUPERIORITY||Mean Difference (Final Values)|-60.53|||<|0.001|TWO_SIDED|90.0|-69.79|-48.43|||Mixed Models Analysis|||Aβ 1-40||-48.43|-69.79|<0.001
91723860|NCT02989389|183341197|SUPERIORITY||Mean Difference (Final Values)|-87.07|||<|0.001|TWO_SIDED|90.0|-90.21|-82.92|||Mixed Models Analysis|||Aβ 1-40||-82.92|-90.21|<0.001
91723861|NCT02989389|183341197|SUPERIORITY||Mean Difference (Final Values)|-19.6||||0.015|TWO_SIDED|90.0|-33.69|-2.51|||Mixed Models Analysis|||Aβ 1-42||-2.51|-33.69|0.015
91723862|NCT02989389|183341197|SUPERIORITY||Mean Difference (Final Values)|-65.41|||<|0.001|TWO_SIDED|90.0|-72.23|-56.92|||Mixed Models Analysis|||Aβ 1-42||-56.92|-72.23|<0.001
91489708|NCT01681472|182852178|SUPERIORITY|||||||0.1796|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1796
91489709|NCT01681472|182852178|SUPERIORITY|||||||0.3243|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3243
91489710|NCT01681472|182852178|SUPERIORITY|||||||0.0263|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0263
91489711|NCT01681472|182852178|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
91723863|NCT02989389|183341197|SUPERIORITY||Mean Difference (Final Values)|-84.56|||<|0.001|TWO_SIDED|90.0|-88.97|-78.38|||Mixed Models Analysis|||Aβ 1-42||-78.38|-88.97|<0.001
91723864|NCT00088153|183341206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||After controlling for baseline age and weight changes|t-test, 2 sided|We also used a mixed model analysis of variance (PROC MIXED), to analyze longitudinal data.||Power analysis: We have previously demonstrated that normal female adolescents gain bone density at the rate of 0.039 +/- 0.0507 per year. The pooled SD in that study was 0.046. Based on these data, with a sample size of 110 girls with anorexia nervosa (AN), half of whom are randomized to receive estrogen and half placebo (with a 10% drop-out rate), there will be an 80% chance that we will detect an increase in bone density to 75% of normal in the girls who receive estrogen.||||<0.05
91723865|NCT00088153|183341207|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there would be no differences between the groups for changes in P1NP levels over time||||>0.05
91723866|NCT00088153|183341208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||The p value was adjusted for age and weight changes|t-test, 2 sided|||The null hypothesis was that the groups would not differ for changes in spine bone density z-scores over the study duration||||<0.05
91723867|NCT01063114|183341217|OTHER||3-Year Cumulative incidence|26.0|||||TWO_SIDED|95.0|16.0|37.0||||||||37|16|
91723868|NCT01063114|183341217|OTHER||5-Year Cumulative incidence|27.0|||||TWO_SIDED|95.0|17.0|38.0||||||||38|17|
91723869|NCT01063114|183341218|OTHER||3-Year Cumulative incidence|46.0|||||TWO_SIDED|95.0|34.0|57.0||||||||57|34|
91694091|NCT00463047|183283397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4481||||0.0191|TWO_SIDED|95.0|1.1|2.0|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.1|0.0191
91694092|NCT00463047|183283398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4396||||0.0006|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0006
91694093|NCT00463047|183283399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3426||||0.0044|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0044
91694094|NCT00463047|183283400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1448||||0.2184|TWO_SIDED|95.0|0.9|1.4|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.2184
91694095|NCT00463047|183283401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9249||||0.5808|TWO_SIDED|95.0|0.7|1.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.2|0.7|0.5808
91694096|NCT00463047|183283402|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8908|||<|0.0001|TWO_SIDED|95.0|1.7|2.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||2.2|1.7|<0.0001
91694097|NCT00463047|183283403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5841|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
91694098|NCT04278417|183283422|NON_INFERIORITY|Non-inferiority of brolucizumab to PRP with respect to change from baseline in BCVA at Week 54, considering a non-inferiority margin of 4 ETDRS letters. Assuming that the BCVA changes follow a normal distribution with equal means between treatments, and a common standard deviation of 10 letters, for a one-sided alpha level of 0.025, with 300 subjects per arm there is \>99% power to reject the null hypothesis that brolucizumab 6 mg is inferior to PRP.|LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|2.4|6.4|||ANCOVA|||1||6.4|2.4|<0.001
91694099|NCT04278417|183283422|SUPERIORITY||||||<|0.001|||||||ANCOVA|||2||||<0.001
91694100|NCT04278417|183283423|SUPERIORITY||Difference in % of Participants|39.4|||<|0.001|TWO_SIDED|95.0|32.0|46.8|||Cochran-Mantel-Haenszel|||||46.8|32.0|< 0.001
91694101|NCT04278417|183283425|SUPERIORITY||Difference in % of Participants|-41.1|||<|0.001|TWO_SIDED|95.0|-48.0|-34.2|||Cochran-Mantel-Haenszel|||||-34.2|-48.0|< 0.001
91694102|NCT04278417|183283428|SUPERIORITY||Difference in % of Participants|26.4|||<|0.001|TWO_SIDED|95.0|19.5|33.3|||Cochran-Mantel-Haenszel|||Week 54||33.3|19.5|<0.001
91694103|NCT01732458|183283499|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-16.5|||||TWO_SIDED|95.0|-34.0|2.0||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||2.0|-34.0|
91694104|NCT01732458|183283499|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-4.4|||||TWO_SIDED|95.0|-22.9|14.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||14.3|-22.9|
91694105|NCT01732458|183283499|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-12.4|||||TWO_SIDED|95.0|-30.3|6.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||6.3|-30.3|
91694106|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.37|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.002
91694107|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.28|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.018
91705840|NCT00432276|183306131|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.03|0.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.||Comparison of change from Baseline at Week 52.||0.04|-1.03|0.071
91705841|NCT00432276|183306132|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2||||0.058|TWO_SIDED|95.0|-8.6|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.1|-8.6|0.058
91489712|NCT01681472|182852178|SUPERIORITY|||||||0.2041|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2041
91489713|NCT01681472|182852178|SUPERIORITY|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||||||0.0061
91527998|NCT02223065|182931028|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.013||||0.3191|TWO_SIDED|90.0|0.992|1.034|||ANOVA|||||1.034|0.992|0.3191
91694108|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.32|||=|0.02|TWO_SIDED|||||The above p value corresponds to the Bladder 10 left (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 left (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.020
91694109|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.39|||=|0.025|TWO_SIDED|||||The above p value corresponds to the Bladder 10 right (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 right (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.025
91694110|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.55|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
91694111|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.57|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
91694112|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.36|||=|0.139|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.139
91694113|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.3|||=|0.011|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.011
91694114|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.67|||=|0.01|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.010
91694115|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.62|||=|0.06|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.06
91694116|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.51|||=|0.05|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.050
91694117|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.41|||=|0.068|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.068
91694118|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.59|||=|0.049|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.049
91723870|NCT01063114|183341218|OTHER||5-Year Cumulative incidence|67.0|||||TWO_SIDED|95.0|54.0|77.0||||||||77|54|
91694119|NCT05870371|183283501|OTHER||Mean Difference (Net)|0.73|||=|0.004|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.004
91694120|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|0.03|=|0.297|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.297
91694121|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|=|0.855|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.855
91694122|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.594|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.594
91694123|NCT05870371|183283501|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.02|=|0.929|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.929
91694124|NCT05870371|183283501|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.05|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
91705842|NCT00432276|183306133|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.228|TWO_SIDED|95.0|-1.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.4|-1.7|0.228
91705843|NCT00432276|183306134|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.132|TWO_SIDED|95.0|-6.5|0.9||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.9|-6.5|0.132
91705844|NCT00432276|183306135|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.6||||0.08|TWO_SIDED|95.0|-18.3|1.0||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.||Comparison of change from Baseline at Week 52.||1.0|-18.3|0.080
91705845|NCT00432276|183306136|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0314||||0.059|TWO_SIDED|95.0|-0.064|0.0012||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as covariates.||Comparison of change from Baseline at Week 52.||0.0012|-0.0640|0.059
91705846|NCT00432276|183306137|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.9|2.6||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.||Comparison of change from Baseline at Week 52.||2.6|-2.9|0.934
91705847|NCT00432276|183306138|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.||Comparison of change from Baseline at Week 52.||0.1|-1.3|0.070
91489714|NCT01681472|182852179|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91694125|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
91694126|NCT05870371|183283501|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.398|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.398
91694127|NCT05870371|183283501|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.03|=|0.186|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.186
91694128|NCT05870371|183283501|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.833|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.833
91694129|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.469|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.469
91694130|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.399|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.399
91705848|NCT00432276|183306139|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9||||0.064|TWO_SIDED|95.0|-5.9|0.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.||Comparison of change from Baseline at Week 52.||0.2|-5.9|0.064
91723871|NCT01063114|183341219|OTHER||Mean Difference (Net)|-11.0||||0.01024|TWO_SIDED|95.0|-19.2|-2.9|||t-test, 2 sided|Paired t test||||-2.9|-19.2|0.01024
91723872|NCT01063114|183341220|OTHER||3-Year Survival Probability|83.2|||||TWO_SIDED|95.0|75.8|91.3||||||||91.3|75.8|
91723873|NCT01063114|183341220|OTHER||5-Year Survival Probability|79.6|||||TWO_SIDED|95.0|71.7|88.5||||||||88.5|71.7|
91489715|NCT01681472|182852179|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489716|NCT01681472|182852179|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91723874|NCT03409367|183341223|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|0.84||||0.019|TWO_SIDED|95.0|0.73|0.97|||Regression, log-binomial||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|The null hypothesis is that the cumulative incidence of atopic dermatitis does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio is equal to 1.||0.97|0.73|0.019
91723875|NCT03409367|183341224|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.76||||0.002|TWO_SIDED|95.0|0.65|0.9|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of parent-reported AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.90|0.65|0.002
91723876|NCT03409367|183341225|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.86||||0.323|TWO_SIDED|95.0|0.65|1.15||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|Regression, log-binomial|||The null hypothesis is that the cumulative incidence of AD by modified UK Working Party criteria does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.15|0.65|0.323
91723877|NCT03409367|183341226|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.83||||0.044|TWO_SIDED|95.0|0.7|0.99|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD by CEQ does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.99|0.70|0.044
91723878|NCT03409367|183341227|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.84|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD with prescription or OTC therapies in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.84|0.55|0.0004
91694131|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.752|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.752
91694132|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.002|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.002
91694133|NCT05870371|183283501|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.003|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.003
91694134|NCT05870371|183283502|OTHER||Mean Difference (Net)|5.41|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.002
91694135|NCT05870371|183283502|OTHER||Mean Difference (Net)|4.92|||=|0.046|TWO_SIDED|||||The above p value corresponds to the Rotation average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.046
91694136|NCT05870371|183283502|OTHER||Mean Difference (Net)|3.81|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.001
91723879|NCT03409367|183341228|EQUIVALENCE|The odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of recommended treatment.|Odds Ratio (OR)|0.7||||0.004|TWO_SIDED|95.0|0.55|0.89||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations of 199 missing outcomes.|Regression, proportional odds|||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.89|0.55|0.004
91723880|NCT03409367|183341229|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of treatment.|Odds Ratio (OR)|0.72||||0.013|TWO_SIDED|95.0|0.56|0.93|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.93|0.56|0.013
91694137|NCT05870371|183283502|OTHER||Mean Difference (Net)|3.57|||=|0.043|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.043
91694138|NCT05870371|183283502|OTHER||Mean Difference (Net)|4.52|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.018
91694139|NCT05870371|183283502|OTHER||Mean Difference (Net)|4.45|||=|0.102|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.102
91694140|NCT05870371|183283502|OTHER||Mean Difference (Net)|5.85|||=|0.16|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.160
91694141|NCT05870371|183283502|OTHER||Mean Difference (Net)|5.48|||<|0.039|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.039
91694142|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.001|TWO_SIDED|||||The above p-value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.001
91694143|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.002|TWO_SIDED||||||Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.002
91694144|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-4.84|STANDARD_ERROR_OF_MEAN|1.6|=|0.048|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.048
91694145|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-2.0|STANDARD_ERROR_OF_MEAN|1.06|=|0.059|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.059
91705849|NCT00432276|183306140|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-1.0|-0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.||Comparison of change from Baseline at Week 52.||-0.1|-1.0|0.022
91723881|NCT03409367|183341230|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.92||||0.509|TWO_SIDED|95.0|0.73|1.17|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of skin infections in the health record does not differ between the Daily Emollient and Natural Skin arms.||1.17|0.73|0.509
91705850|NCT00432276|183306141|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78||||0.308|TWO_SIDED|95.0|-1.65|5.22||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.||Comparison of change from Baseline at Week 52.||5.22|-1.65|0.308
91705851|NCT00432276|183306142|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8209||||0.283|TWO_SIDED|95.0|-2.3209|0.679||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.||Comparison of change from Baseline at Week 52.||0.6790|-2.3209|0.283
91705852|NCT00432276|183306143|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.57|-1.27||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.||Comparison of change from Baseline at Week 52.||-1.27|-4.57|<0.001
91705853|NCT00432276|183306144|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1||||0.197|TWO_SIDED|95.0|-15.4|3.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|||Comparison of change from Baseline at Week 52.||3.2|-15.4|0.197
91705854|NCT00207727|183306187|SUPERIORITY_OR_OTHER|||||||0||95.0||||The p-value was non estimable because the observed trend was in the opposite direction of that stated in the one sided alternative hypothesis|Jonckheere Terpstra|Jonckheere Terpstra nonparametric trend test procedure with 5% level of significance was be used to test for the monotonic trend.||Hypothesis: The null hypothesis of no effect among the treatment groups was tested against the alternative hypothesis that the cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs through Week 23 would decrease monotonically with dose at a significance level of 0.05.||||0.00
91705855|NCT00207727|183306188|SUPERIORITY_OR_OTHER|||||||0.892||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.892
91705856|NCT00207727|183306188|SUPERIORITY_OR_OTHER|||||||0.599||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.599
91705857|NCT00207727|183306188|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.517
91705858|NCT00207727|183306188|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||2-sided Wilcoxon Mann-Whitney|||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group.||||0.967
91705859|NCT00207727|183306189|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.720
91705860|NCT00207727|183306189|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.152
91705861|NCT00207727|183306189|SUPERIORITY_OR_OTHER|||||||0.431||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.431
91705862|NCT00207727|183306189|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo..||||0.292
91705863|NCT03759366|183306190|SUPERIORITY||Least Square Mean|-5.8||||0.0004|TWO_SIDED|95.0|-8.4|-3.13|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 26 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-3.13|-8.40|0.0004
91705864|NCT03759366|183306204|SUPERIORITY||Least Square Mean|-4.3||||0.0033|TWO_SIDED|95.0|-6.93|-1.65|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 52 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-1.65|-6.93|0.0033
91705865|NCT01093651|183306227|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|Study subject was included in these models as a random variable to account for within-participant correlation.||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
91705866|NCT01093651|183306228|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
91705867|NCT01093651|183306229|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
91723882|NCT03409367|183341231|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|1.05||||0.9|TWO_SIDED|95.0|0.5|2.18|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of asthma in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||2.18|0.50|0.900
91723883|NCT03409367|183341232|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.47||||0.064|TWO_SIDED|95.0|0.98|2.21|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|The daily emollient is in the numerator and the natural skin is in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.21|0.98|0.064
91723884|NCT03409367|183341233|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.62||||0.007|TWO_SIDED|95.0|1.14|2.3|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily emollient in the numerator and natural skin in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.30|1.14|0.007
91723885|NCT03409367|183341234|EQUIVALENCE|The ordinal odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.45||||0.07|TWO_SIDED|95.0|0.97|2.18|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily moisturizer is the numerator and natural skin is the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.18|0.97|0.070
91723886|NCT03409367|183341235|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.36||||0.085|TWO_SIDED|95.0|0.96|1.91|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.||1.91|0.96|0.085
91723887|NCT03409367|183341236|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.75||||0.079|TWO_SIDED|95.0|0.55|1.03|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of immediate food allergy reactions does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.03|0.55|0.079
91723888|NCT03409367|183341237|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.66|||Regression, log-binomial|||The null hypothesis is that the cumulative incidence of food allergies does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.66|0.45|0.669
91723889|NCT03409367|183341238|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.77||||0.013|TWO_SIDED|95.0|0.62|0.95|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.95|0.62|0.013
91723890|NCT03409367|183341239|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.8||||0.009|TWO_SIDED|95.0|0.67|0.94|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.94|0.67|0.009
91723891|NCT03409367|183341240|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.77||||0.012|TWO_SIDED|95.0|0.63|0.94|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 121 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.94|0.63|0.012
91723892|NCT03409367|183341241|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.9||||0.303|TWO_SIDED|95.0|0.73|1.1|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 78 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.10|0.73|0.303
91723893|NCT03279458|183341297|OTHER|least square regression analysis|correlation coefficient (R)|0.94|||<|0.05|TWO_SIDED|95.0|0.88|0.97|||Regression, Linear|||||0.97|0.88|<0.05
91723894|NCT03018938|183341301|NON_INFERIORITY|If Lower limit (L) \>-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) \<0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established|LS Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.0959||0.1009|TWO_SIDED|95.0|-0.346|0.031|||ANCOVA|||||0.031|-0.346|0.1009
91723895|NCT03018938|183341302|SUPERIORITY||LS Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.0891||0.0246|TWO_SIDED|95.0|-0.376|-0.026|||ANCOVA|||||-0.026|-0.376|0.0246
91723896|NCT03018938|183341303|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0941|TWO_SIDED|95.0|0.95|1.87|||Regression, Logistic|||||1.87|0.95|0.0941
91723897|NCT03018938|183341304|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8592|TWO_SIDED|95.0|0.72|1.49|||Regression, Logistic|||||1.49|0.72|0.8592
91694146|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-0.92|STANDARD_ERROR_OF_MEAN|1.62|=|0.57|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.57
91694147|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-0.14|STANDARD_ERROR_OF_MEAN|1.65|=|0.931|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.931
91694148|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-1.17|STANDARD_ERROR_OF_MEAN|1.99|=|0.558|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension maximum . The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.558
91694149|NCT05870371|183283502|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|1.96|=|0.989|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.989
91694150|NCT05870371|183283503|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null hypothesis: The application of ATM does not affect the strength of deep neck flexor muscles as measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
91694151|NCT05870371|183283503|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.01|=|0.437|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of applying ATM does not differ in improving the strength of deep neck flexor muscles measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic neck pain than applying A-S (secondary hypothesis).||||=0.437
91694152|NCT05870371|183283504|OTHER||Mean Difference (Net)|0.02|||=|0.919|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.919
91694153|NCT05870371|183283504|OTHER||Dependence coefficients (β)|-0.05|STANDARD_ERROR_OF_MEAN|0.02|=|0.01|TWO_SIDED|||||The above value corresponds to the comparison between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||The above value corresponds to the comparison between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.010
91694154|NCT05870371|183283505|OTHER||Mean Difference (Net)|0.09|||=|0.659|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.659
91694155|NCT05870371|183283505|OTHER||Dependence coefficient (β)|-0.04|STANDARD_ERROR_OF_MEAN|0.02|=|0.05|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.05
91723898|NCT03018938|183341305|SUPERIORITY||LS Mean Difference (Final Values)|0.423|STANDARD_ERROR_OF_MEAN|0.2152||0.0497|TWO_SIDED|95.0|0.0|0.846|||ANCOVA|||||0.846|0.000|0.0497
91723899|NCT03018938|183341306|SUPERIORITY||LS Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.1955||0.001|TWO_SIDED|95.0|0.263|1.031|||ANCOVA|||||1.031|0.263|0.0010
91723900|NCT03018938|183341307|SUPERIORITY||LS Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.2191||0.2193|TWO_SIDED|95.0|-0.161|0.7|||ANCOVA|||FBG||0.700|-0.161|0.2193
91723901|NCT03018938|183341307|SUPERIORITY||LS Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.3331||0.8014|TWO_SIDED|95.0|-0.739|0.571|||ANCOVA|||PPG||0.571|-0.739|0.8014
91694156|NCT05870371|183283506|OTHER||Mean Difference (Net)|10.28|||=|0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.09
91694157|NCT05870371|183283506|OTHER||Dependence coefficient (β)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|=|0.005|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.005
91694158|NCT05870371|183283507|OTHER||Mean Difference (Net)|-7.87|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total McGill Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total McGill Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694159|NCT05870371|183283507|OTHER||Mean Difference (Net)|-5.55|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Sensory Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694160|NCT05870371|183283507|OTHER||Mean Difference (Net)|-2.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Affective Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694161|NCT05870371|183283507|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.996|TWO_SIDED|||||The above p-value corresponds to the Total McGill score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.996
91694162|NCT05870371|183283507|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.968|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.968
91694163|NCT05870371|183283507|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.854|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.854
91694164|NCT05870371|183283508|OTHER||Mean Difference (Net)|-2.59|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||||||<0.001
91694165|NCT05870371|183283508|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.952|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.952
91694166|NCT05870371|183283509|OTHER||Mean Difference (Net)|-1.06|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.||||||<0.001
91723902|NCT03018938|183341308|SUPERIORITY||LS Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.2033||0.016|TWO_SIDED|95.0|0.092|0.891|||ANCOVA|||FBG||0.891|0.092|0.0160
91723903|NCT03018938|183341308|SUPERIORITY||LS Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.3028||0.9661|TWO_SIDED|95.0|-0.608|0.582|||ANCOVA|||PPG||0.582|-0.608|0.9661
91723904|NCT03018938|183341310|SUPERIORITY||LS Mean Difference|0.667|STANDARD_ERROR_OF_MEAN|0.2776||0.0166|TWO_SIDED|95.0|0.122|1.211|||ANCOVA|||||1.211|0.122|0.0166
91723905|NCT03018938|183341311|SUPERIORITY||LS Mean Difference (Final Values)|0.754|STANDARD_ERROR_OF_MEAN|0.2864||0.0086|TWO_SIDED|95.0|0.192|1.316|||ANCOVA|||||1.316|0.192|0.0086
91489717|NCT01681472|182852179|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91723906|NCT03018938|183341314|SUPERIORITY||Odds Ratio (OR)|1.25||||0.2009|TWO_SIDED|95.0|0.89|1.77|||Regression, Logistic|||||1.77|0.89|0.2009
91723907|NCT03018938|183341315|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8054|TWO_SIDED|95.0|0.72|1.53|||Regression, Logistic|||||1.53|0.72|0.8054
91723908|NCT03018938|183341316|SUPERIORITY||LS Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7553|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|||||0.5|-0.8|0.7553
91694167|NCT05870371|183283509|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.989|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.989
91694168|NCT05870371|183283510|OTHER||Mean Difference (Net)|-5.6|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the functionality recorded with the Neck Disability Index (NDI) in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
91694169|NCT05870371|183283510|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.973|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of functionality recorded with the Neck Disability Index (NDI) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.973
91694170|NCT05870371|183283511|OTHER||Mean Difference (Net)|-2.11|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Depression subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694171|NCT05870371|183283511|OTHER||Mean Difference (Net)|-2.05|||<|0.001|TWO_SIDED|||||The above value corresponds to the Anxiety subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Anxiety subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694172|NCT05870371|183283511|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.04|=|0.305|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Depression subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.305
91694173|NCT05870371|183283511|OTHER||Dependence coefficient (β)|0.05|STANDARD_ERROR_OF_MEAN|0.03|=|0.137|TWO_SIDED|||||The above p-value corresponds to the Anxiety subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above values correspond to the Anxiety subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.137
91694174|NCT05870371|183283512|OTHER||Mean Difference (Net)|-3.82|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the kinesiophobia as measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694175|NCT05870371|183283512|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.01|=|0.151|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing kinesiophobia measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.151
91694176|NCT05870371|183283512|OTHER||||||=|0.021||||||The threshold for statistical significance was p \< 0.05.|McNemar|||||||=0.021
91723909|NCT02141113|183341358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These changed scores show the total change in ADHD symptoms over the course of the trial. Higher values indiicate improved functioning at the end of the trial compared to the beginning.||||.779
91723910|NCT02141113|183341359|SUPERIORITY|||||||0.834|||||||ANOVA|||||||.834
91723911|NCT02141113|183341360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.705|TWO_SIDED||||||ANOVA|||||||.705
91723912|NCT02141113|183341361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|TWO_SIDED||||||ANOVA|||||||.322
91723913|NCT02141113|183341362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
91723914|NCT02141113|183341363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|TWO_SIDED||||||ANOVA|||||||.212
91489718|NCT01681472|182852179|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489719|NCT01681472|182852179|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91723915|NCT03921541|183341445|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91723916|NCT03921541|183341446|SUPERIORITY|||||||0.5961|||||||Mixed Models Analysis|||||||0.5961
91723917|NCT03921541|183341447|SUPERIORITY|||||||0.1087|||||||Mixed Models Analysis|||||||0.1087
91723918|NCT03921541|183341448|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91723919|NCT03921541|183341449|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91489720|NCT01681472|182852180|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
91489721|NCT01681472|182852180|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489722|NCT01681472|182852180|SUPERIORITY|||||||0.0227|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0227
91723920|NCT03921541|183341450|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91723921|NCT03921541|183341452|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
91723922|NCT03921541|183341453|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91723923|NCT03921541|183341454|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91723924|NCT03921541|183341455|SUPERIORITY|||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
91723925|NCT03921541|183341456|SUPERIORITY|||||||0.4434|||||||Mixed Models Analysis|||||||0.4434
91723926|NCT03921541|183341457|SUPERIORITY|||||||0.5301|||||||Mixed Models Analysis|||||||0.5301
91723927|NCT03921541|183341458|SUPERIORITY|||||||0.2515|||||||Mixed Models Analysis|||||||0.2515
91723928|NCT04633447|183341488|SUPERIORITY||Difference in Percentage|6.6|||=|0.638|TWO_SIDED|90.0|-14.7|27.9|||Cochran-Mantel-Haenszel|||||27.9|-14.7|=0.638
91723929|NCT04333498|183341503|OTHER||Mean Difference (Net)|-221.03||||0.014|TWO_SIDED|95.0|-396.33|-45.73|||t-test, 2 sided|||||-45.73|-396.33|.014
91723930|NCT04333498|183341504|OTHER||Mean Difference (Net)|1103.96||||0.122|TWO_SIDED|95.0|-296.532|2502.722|||t-test, 2 sided|||||2502.722|-296.532|0.122
91723931|NCT04333498|183341505|OTHER||Mean Difference (Net)|-2.61||||0.218|TWO_SIDED|95.0|-8.614|3.391|||t-test, 2 sided|||Adherence percentage||3.391|-8.614|.218
91723932|NCT04333498|183341505|OTHER|Linear regression with generalized estimating equations (GEE)|Slope|0.046||||0.272|TWO_SIDED|95.0|-0.036|0.128|||Regression, Linear|||||0.128|-0.036|0.272
91723933|NCT01565694|183341506|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
91723934|NCT01565694|183341506|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
91723935|NCT01565694|183341507|OTHER|P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91723936|NCT01565694|183341508|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.029|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.029
91723937|NCT01565694|183341508|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.026|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.026
91723938|NCT01565694|183341509|OTHER|From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Analysis of change from baseline to Week 24.||||<0.001
91723939|NCT01565694|183341510|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.006|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.||||0.006
91723940|NCT01565694|183341510|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.||||0.001
91723941|NCT01565694|183341511|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.||||0.001
91723942|NCT01565694|183341511|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.||||0.004
91723943|NCT01565694|183341512|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.003|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.003
91723944|NCT01565694|183341512|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.028|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.028
91723945|NCT01565694|183341513|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.068|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.068
91723946|NCT01565694|183341513|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.075|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.075
91723947|NCT01565694|183341514|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
91723948|NCT01565694|183341514|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
91723949|NCT01565694|183341515|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
91723950|NCT01565694|183341515|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
91723951|NCT01565694|183341516|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
91723952|NCT01565694|183341516|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
91723953|NCT01565694|183341517|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
91723954|NCT01565694|183341517|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
91723955|NCT01565694|183341518|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.01|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.010
91723956|NCT01565694|183341518|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.004
91723957|NCT01565694|183341519|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
91723958|NCT01565694|183341519|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
91723959|NCT01565694|183341520|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.568|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.568
91489723|NCT01681472|182852180|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489724|NCT01681472|182852180|SUPERIORITY|||||||0.0933|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0933
91489725|NCT01681472|182852180|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91723960|NCT01565694|183341520|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.573|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.573
91723961|NCT00541229|183341561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.8||||0.004||95.0|-53.1|-10.5|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 200 mg group.||-10.5|-53.1|0.004
91723962|NCT00541229|183341561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.9|||<|0.001||95.0|-63.6|-20.2|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 100 mg group.||-20.2|-63.6|<0.001
91723963|NCT00541229|183341561|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis stated that the lower bound of 80% one-sided confidence interval for the comparison in 24-hour WMG reduction between sitagliptin 200 mg and sitagliptin 100 mg is above -5 mg/dL.|Mean Difference (Final Values)|10.1||||||80.0|0.61|9999999.0|||||This is a 1-sided 80% confidence interval and the upper bound 9999999 was used here to indicate positive infinity.|This was pre-defined as a non-superiority test, i.e., to show that sitagliptin 200 mg is not superior to sitagliptin 100 mg. For this comparison, the mean in the sitagliptin 100 mg group was subtracted from the mean in the sitagliptin 200 mg group.||9999999|0.61|
91723964|NCT01312129|183341562|SUPERIORITY_OR_OTHER||||||=|0.05|TWO_SIDED|||||=0.05 is the actual computed p-value via the ANOVA.|ANOVA|The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo \& Sulfasalazine .||||||=.05
91723965|NCT02397837|183341569|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
91723966|NCT02397837|183341570|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
91723967|NCT02397837|183341571|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91723968|NCT02397837|183341572|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
91723969|NCT02397837|183341573|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
91723970|NCT02397837|183341574|OTHER|||||||0.98|||||||t-test, 2 sided|||||||0.98
91723971|NCT02397837|183341575|OTHER||||||||||||||||||Tabulation of participants with suicidal acknowledgements over 12-week study|||
91723972|NCT02397837|183341576|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
91723973|NCT02397837|183341577|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
91723974|NCT02397837|183341578|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91723975|NCT04602000|183341630|SUPERIORITY||Difference estimated using CMH weights|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.7|-4.5|||Cochran-Mantel-Haenszel|P-value was calculated using CMH test stratified by age (≥60 vs. \<60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other)|The 95% stratified Newcombe CI with CMH weights was presented.|||-4.5|-11.7|<0.0001
91723976|NCT01257542|183341648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.252|TWO_SIDED|95.0|0.59|1.15||p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.|Negative binomial regression|||Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.||1.15|0.59|0.252
91723977|NCT01257542|183341649|SUPERIORITY_OR_OTHER||LS mean difference|-0.26||||0.134|TWO_SIDED|95.0|-0.6|0.08||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.||0.08|-0.60|0.134
91723978|NCT01257542|183341650|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.768|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.33|-0.45|0.768
91723979|NCT01257542|183341650|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.358|TWO_SIDED|95.0|-0.64|0.23||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.23|-0.64|0.358
91723980|NCT01257542|183341650|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.139|TWO_SIDED|95.0|-0.74|0.1||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.10|-0.74|0.139
91723981|NCT01257542|183341650|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.364|TWO_SIDED|95.0|-0.68|0.25||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.25|-0.68|0.364
91723982|NCT01257542|183341650|SUPERIORITY_OR_OTHER||LS mean difference|-0.46||||0.039|TWO_SIDED|95.0|-0.9|-0.02||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||-0.02|-0.90|0.039
91723983|NCT01257542|183341650|SUPERIORITY_OR_OTHER||LS mean difference|-0.29||||0.206|TWO_SIDED|95.0|-0.75|0.16||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.16|-0.75|0.206
91723984|NCT01257542|183341651|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.304|TWO_SIDED|95.0|-1.43|0.45||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.45|-1.43|0.304
91723985|NCT01257542|183341652|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.954|TWO_SIDED|95.0|-1.03|0.97||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.97|-1.03|0.954
91723986|NCT01257542|183341652|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.426|TWO_SIDED|95.0|-1.54|0.65||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.65|-1.54|0.426
91723987|NCT01257542|183341652|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.396|TWO_SIDED|95.0|-1.49|0.6||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.60|-1.49|0.396
91723988|NCT01257542|183341652|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.402|TWO_SIDED|95.0|-1.63|0.66||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.66|-1.63|0.402
91723989|NCT01257542|183341652|SUPERIORITY_OR_OTHER||LS mean difference|-0.69||||0.204|TWO_SIDED|95.0|-1.75|0.38||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.38|-1.75|0.204
91723990|NCT01257542|183341652|SUPERIORITY_OR_OTHER||LS mean difference|-0.84||||0.179|TWO_SIDED|95.0|-2.06|0.39||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.39|-2.06|0.179
91723991|NCT01257542|183341653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.523|TWO_SIDED|95.0|-0.21|0.39||p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.39|-0.21|0.523
91723992|NCT01257542|183341654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.796|TWO_SIDED|95.0|-0.35|0.24||p-value was calculated from the CMH test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.24|-0.35|0.796
91723993|NCT00693303|183341665|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||.27
91723994|NCT00195429|183341671|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.0
91723995|NCT00195429|183341672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Student's t-test|||||||0.361
91723996|NCT04837521|183341688|SUPERIORITY||γ01|0.25||||0.03|TWO_SIDED||||||t-test, 2 sided||analysis completed using the 1 week follow up data|||||.03
91694177|NCT05870371|183283513|OTHER||Mean Difference (Net)|-4.24|||=|0.006|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_physical subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.006
91694178|NCT05870371|183283513|OTHER||Mean Difference (Net)|-2.24|||=|0.001|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_work subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.001
91694179|NCT05870371|183283513|OTHER||Dependence coefficient (β)|0.1|STANDARD_ERROR_OF_MEAN|0.07|=|0.197|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_work subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.197
91694180|NCT05870371|183283513|OTHER||Dependence coefficient (β)|0.07|STANDARD_ERROR_OF_MEAN|0.04|=|0.066|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_physical subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.066
91694181|NCT05870371|183283514|OTHER||Mean Difference (Net)|-7.07|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total PCS score.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694182|NCT05870371|183283514|OTHER||Mean Difference (Net)|-2.02|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rumination subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694183|NCT05870371|183283514|OTHER||Mean Difference (Net)|-1.66|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Magnification subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694184|NCT05870371|183283514|OTHER||Mean Difference (Net)|-3.39|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Helplessness subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694185|NCT05870371|183283514|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.871|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Total PCS score. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).|The above values correspond to the comparison which is between groups at baseline.|||=0.871
91489726|NCT01681472|182852181|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
91758702|NCT00235716|183410637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.84|TWO_SIDED|95.0|-1.32|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-1.32|0.84
91489727|NCT01681472|182852181|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91705868|NCT01093651|183306230|SUPERIORITY_OR_OTHER||||||<|0.0002||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p\<0.0002.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.0002
91489728|NCT01681472|182852181|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
91489729|NCT01681472|182852181|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489730|NCT01681472|182852181|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0043
91489731|NCT01681472|182852181|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489732|NCT01681472|182852182|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489733|NCT01681472|182852182|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489734|NCT01681472|182852182|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489735|NCT01681472|182852182|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489736|NCT01681472|182852182|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489737|NCT01681472|182852182|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489738|NCT01681472|182852183|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489739|NCT01681472|182852183|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489740|NCT01681472|182852183|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489741|NCT01681472|182852183|SUPERIORITY|||||||0.0668|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0668
91489742|NCT01681472|182852183|SUPERIORITY|||||||0.0502|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0502
91489743|NCT01681472|182852183|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
91489744|NCT01681472|182852184|SUPERIORITY|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0011
91489745|NCT01681472|182852184|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489746|NCT01681472|182852184|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489747|NCT01681472|182852184|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489748|NCT01681472|182852184|SUPERIORITY|||||||0.6691|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.6691
91723997|NCT04837521|183341689|OTHER|The conditions were expected to be similar, and the primary interest of the analysis was changes over time across both groups.|Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|2.32|4.49||To estimate the mean improvement in PSFS across the entire sample, we calculated a posterior predictive distribution of within-person change scores between time fixed equal to 0 and equal to -1.|Bayesian framework|||PSFS scores were analyzed using mixed-effects linear growth models with time, treatment condition, and their interaction as predictors. Random effects modeled variation in intercepts, slopes over time, and their covariance. Time was specified as a continuous variable, centered on the final observation date. The SG group served as the reference level for the treatment factor. Models were estimated in a Bayesian framework using default priors in the brms package.||4.49|2.32|
91723998|NCT04470427|183341723|OTHER||VE|93.2|||<|0.0001|TWO_SIDED|95.0|91.0|94.8|||Vaccine Efficacy (VE)|VE (percent) is demonstrated if the lower limit of the 2-sided confidence interval for the VE is above 30%.|VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|"Vaccine efficacy was defined as the percent reduction in the hazard of the primary endpoint (mRNA-1273 vs. placebo).~Null hypothesis of Vaccine Efficacy ≤30%, 95% CI."||94.8|91.0|<.0001
91489749|NCT01681472|182852184|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489750|NCT01681472|182852185|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
91489751|NCT01681472|182852185|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489752|NCT01681472|182852185|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0640
91489753|NCT01681472|182852185|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489754|NCT01681472|182852185|SUPERIORITY|||||||0.1213|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1213
91723999|NCT04470427|183341729|OTHER||VE|98.2|||||TWO_SIDED|95.0|92.8|99.6|||VE||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||99.6|92.8|
91724000|NCT04470427|183341730|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.2|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model|||84.2|79.5|
91724001|NCT04470427|183341731|OTHER|VE|VE|93.4|||||TWO_SIDED|95.0|91.4|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.4|
91724002|NCT04470427|183341733|OTHER||VE|93.3|||||TWO_SIDED|95.0|91.1|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.1|
91724003|NCT04470427|183341734|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.3|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||84.3|79.5|
91724004|NCT04470427|183341735|OTHER||VE|63.0|||||TWO_SIDED|95.0|56.6|68.5|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||68.5|56.6|
91724005|NCT04470427|183341741|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on Ratio of GMC is demonstrated if lower bound of 95% CI of Ratio of GMC ≥ 0.67.|Ratio of GMC|6.996|||||TWO_SIDED|95.0|6.509|7.52||||||Ratio of GMC 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57).||7.520|6.509|
91489755|NCT01681472|182852185|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489756|NCT01681472|182852186|SUPERIORITY|||||||0.1791|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1791
91724006|NCT04470427|183341742|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on SRR difference is demonstrated if lower bound of 95% CI of SRR difference \> -10%.|Difference in Seroresponse|0.9|||||TWO_SIDED|95.0|0.1|1.8|||||95% CI were calculated using adjusted Wald method for the paired binary data.|Seroresponse 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57)||1.8|0.1|
91724007|NCT01018979|183341745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.023
91724008|NCT01018979|183341745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.038
91489757|NCT01681472|182852186|SUPERIORITY|||||||0.4945|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4945
91489758|NCT01681472|182852186|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
91489759|NCT01681472|182852186|SUPERIORITY|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5990
91489760|NCT01681472|182852186|SUPERIORITY|||||||0.0303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0303
91489761|NCT01681472|182852186|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0107
91489762|NCT01681472|182852187|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91724009|NCT00248547|183341755|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon Rank Sum Test|||||||0.041
91724010|NCT01913353|183341765|NON_INFERIORITY|The non-inferiority margin to show that Group 1 (after 2 doses of MVA-BN) is non-inferior to Group 2 (after 1 dose of ACAM2000) in terms of PRNT GMTs at the respective peak visit (Week 6 in Group 1 / Week 4 in Group 2) was predefined as '1/2 (i.e. 0.5)' for the GMT ratio (Group 1 / Group 2).|GMT Ratio (Group 1 / Group 2)|1.935|||||TWO_SIDED|95.0|1.562|2.397||||||||2.397|1.562|
91724011|NCT01913353|183341766|SUPERIORITY|Predefined threshold of clinical relevance for the area attenuation ratio (AAR): 40%|Area attenuation ratio (AAR)|97.9|||||TWO_SIDED|95.0|96.6|98.3|||||The AAR, i.e. the reduction in MLA \[1 - MLA ratio (Group 1/Group 2)\] after scarification was to be significantly above 40%. The MLA ratio and the corresponding 95% CI were based on the Hodges-Lehmann estimate of the shift for log-transformed MLAs.|||98.3|96.6|
91724012|NCT01260948|183341838|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.72|||||TWO_SIDED|90.0|94.13|103.53|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.53|94.13|
91759984|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-14.61|3.89||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-14.61|
91724013|NCT01260948|183341839|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.81|||||TWO_SIDED|90.0|91.3|98.47|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.47|91.30|
91724014|NCT00768053|183341840|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||F test for H0: ICC = 0|F test|||Intraclass correlation coefficient (ICC)||||0.000
91724015|NCT00768053|183341840|SUPERIORITY_OR_OTHER||standard error of measurement|0.65|||||TWO_SIDED|95.0|0.57|0.75||||||Standardized response mean: standard error of measurement||0.75|0.57|
91724016|NCT00768053|183341842|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
91724017|NCT00768053|183341843|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
91724018|NCT00768053|183341844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
91724019|NCT00768053|183341845|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
91724020|NCT00768053|183341846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
91724021|NCT00768053|183341847|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
91724022|NCT00768053|183341848|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
91724023|NCT00768053|183341848|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||<0.001
91724024|NCT00768053|183341848|SUPERIORITY_OR_OTHER|||||||0.837|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.837
91724025|NCT00768053|183341848|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.035
91724026|NCT00768053|183341848|SUPERIORITY_OR_OTHER|||||||0.351|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.351
91724027|NCT00768053|183341848|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.025
91489763|NCT01681472|182852187|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91489764|NCT01681472|182852187|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
91724028|NCT00768053|183341848|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
91724029|NCT00768053|183341849|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
91724030|NCT00768053|183341849|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||0.052
91724031|NCT00768053|183341849|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.895
91724032|NCT00768053|183341849|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.153
91724033|NCT00768053|183341849|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.029
91724034|NCT00768053|183341849|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.043
91724035|NCT00768053|183341849|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
91759985|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.88|||||TWO_SIDED|95.0|-25.15|-6.61||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.61|-25.15|
91724036|NCT00898807|183341898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.036|TWO_SIDED|95.0|-1.8|-0.06||P-value was not adjusted for multiple comparisons. All p-values are two-sided and p\<0.05 was the threshold for statistical significance.|Mixed Models Analysis|Mixed effects model w/ random intercept for patient, visit indicator, treatment by visit interactions and adjusted for baseline NBRS-A \& cognition.|Negative numbers favor citalopram group.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.||-0.06|-1.80|0.036
91724037|NCT00898807|183341899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.007|TWO_SIDED|95.0|1.23|3.69||All p-values are two-sided and p \<0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.|Proportional odds|estimated treatment effect from the proportional odds model|Positive numbers favors citalopram.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).||3.69|1.23|0.007
91724038|NCT03928327|183341902|OTHER||Geometric Least Squares (LS) Mean Ratio|2.86|||||TWO_SIDED|90.0|2.48|3.3|||||Linear mixed-effects model was used for analysis, using fixed-effect(treatment), random-effect(participants). Geometric mean ratios(GMR), 90% confidence interval(CI) calculated using exponentiation of treatment least squares means(LSMs) difference.|||3.30|2.48|
91724039|NCT03928327|183341903|OTHER||Geometric LS Mean Ratio|0.08|||||TWO_SIDED|90.0|0.07|0.11|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.11|0.07|
91724040|NCT03928327|183341904|OTHER||Geometric LS Mean Ratio|6.27|||||TWO_SIDED|90.0|5.2|7.56|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||7.56|5.20|
91724041|NCT03928327|183341905|OTHER||Geometric LS Mean Ratio|0.05|||||TWO_SIDED|90.0|0.04|0.07|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.07|0.04|
91724042|NCT01482221|183341909|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.695||0.63|TWO_SIDED|95.0|-4.519|2.152||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.152|-4.519|0.630
91724043|NCT01482221|183341909|SUPERIORITY_OR_OTHER||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|1.701||0.476|TWO_SIDED|95.0|-4.563|2.134||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.134|-4.563|0.476
91724044|NCT01482221|183341910|SUPERIORITY_OR_OTHER||LS mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.816||0.63|TWO_SIDED|95.0|-5.628|1.522||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.522|-5.628|0.630
91724045|NCT01482221|183341910|SUPERIORITY_OR_OTHER||LS mean difference|0.88|STANDARD_ERROR_OF_MEAN|1.83||0.63|TWO_SIDED|95.0|-2.72|4.485||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||4.485|-2.720|0.630
91724046|NCT01482221|183341911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|STANDARD_ERROR_OF_MEAN|0.366||0.852|TWO_SIDED|95.0|0.544|2.089||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.089|0.544|0.852
91724047|NCT01482221|183341911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.37||0.821|TWO_SIDED|95.0|0.552|2.115||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.115|0.552|0.821
91694186|NCT05870371|183283514|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|=|0.887|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rumination subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.887
91694187|NCT05870371|183283514|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.879|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Magnification subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.879
91724048|NCT01482221|183341912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.318||0.751|TWO_SIDED|95.0|0.485|1.686|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.686|0.485|0.751
91724049|NCT01482221|183341912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.315||0.555|TWO_SIDED|95.0|0.65|2.233|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.233|0.650|0.555
91724050|NCT01482221|183341913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.304||0.434|TWO_SIDED|95.0|0.699|2.301|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.301|0.699|0.434
91489765|NCT01681472|182852187|SUPERIORITY|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0125
91489766|NCT01681472|182852187|SUPERIORITY|||||||0.0017|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0017
91489767|NCT01681472|182852187|SUPERIORITY|||||||0.5286|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5286
91489768|NCT01681472|182852188|OTHER||Correlation factor|-0.21666||||0.6063|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.6063
91724051|NCT01482221|183341913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.322||0.286|TWO_SIDED|95.0|0.377|1.334|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.334|0.377|0.286
91724052|NCT01482221|183341914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.382||0.357|TWO_SIDED|95.0|0.672|3.007|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||3.007|0.672|0.357
91724053|NCT01482221|183341914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.387||0.463|TWO_SIDED|95.0|0.622|2.84|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.840|0.622|0.463
91724054|NCT01482221|183341915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.342||0.911|TWO_SIDED|95.0|0.532|2.031|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.031|0.532|0.911
91724055|NCT01482221|183341915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.368||0.509|TWO_SIDED|95.0|0.382|1.613|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.613|0.382|0.509
91724056|NCT01482221|183341916|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|1.238||0.889|TWO_SIDED|95.0|-2.609|2.264||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.264|-2.609|0.889
91724057|NCT01482221|183341916|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.264||0.992|TWO_SIDED|95.0|-2.477|2.501||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.501|-2.477|0.992
91724058|NCT01482221|183341916|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.301||0.392|TWO_SIDED|95.0|-1.448|3.678||Analysis for change in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.678|-1.448|0.392
91489769|NCT01681472|182852188|OTHER||Correlation factor|0.54039||||0.2105|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.2105
91489770|NCT01681472|182852188|OTHER||Correlation factor|0.27618||||0.5079|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5079
91489771|NCT01681472|182852188|OTHER||Correlation factor|0.68223||||0.0913|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.0913
91489772|NCT01681472|182852189|OTHER||Correlation factor|0.38298||||0.3964|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.3964
91489773|NCT01681472|182852189|OTHER||Correlation factor|0.27018||||0.5175|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.5175
91527999|NCT03662997|182931041|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular arm, Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
91694188|NCT05870371|183283514|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.961|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Helplessness subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.961
91724059|NCT01482221|183341916|SUPERIORITY_OR_OTHER||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|1.329||0.333|TWO_SIDED|95.0|-1.327|3.908||Analysis for changed in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.908|-1.327|0.333
91724060|NCT01482221|183341917|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.728|TWO_SIDED|95.0|-0.49|0.34||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.34|-0.49|0.728
91724061|NCT01482221|183341917|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.562|TWO_SIDED|95.0|-0.54|0.29||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.29|-0.54|0.562
91724062|NCT01482221|183341917|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.283|TWO_SIDED|95.0|-0.64|0.19||Analysis for change in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.19|-0.64|0.283
91724063|NCT01482221|183341917|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.54|TWO_SIDED|95.0|-0.29|0.55||Analysis for changed in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.55|-0.29|0.540
91724064|NCT01482221|183341918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|STANDARD_ERROR_OF_MEAN|0.302||0.067|TWO_SIDED|95.0|0.962|3.141|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||3.141|0.962|0.067
91724065|NCT01482221|183341918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|STANDARD_ERROR_OF_MEAN|0.297||0.23|TWO_SIDED|95.0|0.798|2.558|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.558|0.798|0.230
91724066|NCT01482221|183341919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.292||0.268|TWO_SIDED|95.0|0.78|2.447|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.447|0.780|0.268
91724067|NCT01482221|183341919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.303||0.909|TWO_SIDED|95.0|0.533|1.75|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||1.750|0.533|0.909
91724068|NCT01482221|183341920|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.505|TWO_SIDED|95.0|-2.29|1.13||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.13|-2.29|0.505
91724069|NCT01482221|183341920|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.88||0.842|TWO_SIDED|95.0|-1.56|1.91||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.91|-1.56|0.842
91724070|NCT01482221|183341920|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.89||0.788|TWO_SIDED|95.0|-1.98|1.51||Analysis for change in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.51|-1.98|0.788
91724071|NCT01482221|183341920|SUPERIORITY_OR_OTHER||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.133|TWO_SIDED|95.0|-0.42|3.12||Analysis for changed in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.12|-0.42|0.133
91724072|NCT01846871|183341933|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
91724073|NCT01846871|183341934|OTHER|||||||0.028|||||||t-test, 2 sided|||||||0.028
91724074|NCT01846871|183341935|OTHER|||||||0.0019|||||||t-test, 2 sided|||||||0.0019
91724075|NCT01846871|183341936|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
91489774|NCT01681472|182852189|OTHER||Correlation factor|-0.02188||||0.959|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.9590
91724076|NCT00081458|183341954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANCOVA|||||||0.007
91724077|NCT00081458|183341955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANCOVA|||An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.||||0.005
91724078|NCT03384966|183341956|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.0001|TWO_SIDED|97.5|22.4|154.8||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values."||154.8|22.4|< 0.0001
91724079|NCT03384966|183341956|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|23.1|162.3||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values in the main analysis."||162.3|23.1|< 0.0001
91724080|NCT03384966|183341960|OTHER|Logistic regression (Type III analysis)||||||0.1915|||||||Chi-squared|||||||0.1915
91724081|NCT03384966|183341962|OTHER||LS Mean difference with placebo|-27.49|||<|0.0001|TWO_SIDED|95.0|-35.4|-19.6|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.||Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.||-19.6|-35.4|<.0001
91724082|NCT03384966|183341962|OTHER||LS Mean difference with placebo|-31.06|||<|0.0001|TWO_SIDED|95.0|-39.0|-23.1|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach||Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.||-23.1|-39.0|<.0001
91489775|NCT01681472|182852189|OTHER||Correlation factor|0.45404||||0.3061|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3061
91489776|NCT01681472|182852189|OTHER||Correlation factor|0.34905||||0.3967|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3967
91489777|NCT01681472|182852189|OTHER||Correlation factor|0.07937||||0.8518|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.8518
91489778|NCT01681472|182852190|OTHER||Correlation factor|0.73743||||0.0586|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0586
91724083|NCT03925220|183342002|SUPERIORITY||Prevalence Ratio (PR)|2.86|||<|0.001|TWO_SIDED|95.0|2.02|4.04||"At 3 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||A sample size of 400 parents and children was calculated to yield 80% power to detect one or more differences between the intervention and control arms, of 45% in talking about alcohol, 20% about marijuana, and 20% about other drugs, using a two-sided Bonferroni-corrected 1.5% level of significance (based on estimates from the pilot trial).||4.04|2.02|<0.001
91724084|NCT03925220|183342002|SUPERIORITY||Prevalence Ratio [PR]|2.4|||<|0.001|TWO_SIDED|95.0|1.67|3.45||"At 3 months:~Parent-reported frequency of conversations on using e-cigarettes or vaping"|Generalized estimation|||||3.45|1.67|<0.001
91724085|NCT03925220|183342002|SUPERIORITY||Prevalence Ratio [PR]|2.36|||<|0.001|TWO_SIDED|95.0|1.62|3.43||"At 3 months:~Parent-reported frequency of conversations on using marijuana"|Generalized estimation|||||3.43|1.62|<0.001
91724086|NCT03925220|183342002|SUPERIORITY||Prevalence Ratio [PR]|3.45|||<|0.001|TWO_SIDED|95.0|2.34|5.08||"At 3 months:~Parent-reported frequency of conversations on smoking cigarettes"|Generalized estimation|||||5.08|2.34|<0.001
91489779|NCT01681472|182852190|OTHER||Correlation factor|0.44757||||0.2661|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.2661
91489780|NCT01681472|182852190|OTHER||Correlation factor|0.03292||||0.9506|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.9506
91489781|NCT01681472|182852190|OTHER||Correlation factor|0.09033||||0.8315|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8315
91489782|NCT01681472|182852190|OTHER||Correlation factor|0.76502||||0.0451|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in adjacent mucosa||||0.0451
91694189|NCT05870371|183283515|OTHER||Mean Difference (Net)|4.99|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Physical Component Summary/PCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91694190|NCT05870371|183283515|OTHER||Mean Difference (Net)|8.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Mental Component Summary/MCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mental Component Summary/MCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
91724087|NCT03925220|183342002|SUPERIORITY||Prevalence Ratio [PR]|2.47|||<|0.001|TWO_SIDED|95.0|1.58|3.86||"At 3 months:~Parent-reported frequency of conversations on using other drugs"|Generalized estimation|||||3.86|1.58|<0.001
91489783|NCT01681472|182852190|OTHER||Correlation factor|0.34496||||0.4027|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.4027
91489784|NCT01681472|182852190|OTHER||Correlation factor|-0.66295||||0.1513|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.1513
91705869|NCT01093651|183306231|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
91724088|NCT03925220|183342002|SUPERIORITY||Prevalence Ratio [PR]|1.45||||0.04|TWO_SIDED|95.0|1.02|2.06||"At 18 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||||2.06|1.02|0.04
91724089|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio (PR)|1.31|||<|0.001|TWO_SIDED|95.0|1.18|1.45||"At 3 months:~Parent-reported have warned your child about the dangers of drinking alcohol and using drugs"|Generalized estimation|||||1.45|1.18|<0.001
91724090|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.55|||<|0.001|TWO_SIDED|95.0|1.32|1.83||"At 3 months:~Parent-reported 'have talked to your child about how to handle offers of alcoholic drinks and drugs'"|Generalized estimation|||||1.83|1.32|<0.001
91724091|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|2.13|||<|0.001|TWO_SIDED|95.0|1.73|2.63||"At 3 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||2.63|1.73|<0.001
91724092|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.67||||0.001|TWO_SIDED|95.0|1.25|2.25||"At 3 months:~Parent-reported 'have lectured or given your child a speech about drinking alcohol and using drugs'"|Generalized estimation|||||2.25|1.25|0.001
91724093|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.51|||<|0.001|TWO_SIDED|95.0|1.21|1.9||"At 3 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.90|1.21|<0.001
91724094|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.25||||0.008|TWO_SIDED|95.0|1.06|1.47||"At 3 months:~Parent-reported 'have told your child stories of people who drink alcohol, have been drunk, or use drugs'"|Generalized estimation|||||1.47|1.06|0.008
91724095|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.1||"At 3 months:~Parent-reported 'have told your child you would be disappointed in her/him if they were to drink alcohol or use drugs'"|Generalized estimation|||||2.10|1.29|<0.001
91724096|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.15||"At 3 months:~Parent-reported 'have shown your child information on the web, TV, or in the news about the dangers of drinking alcohol and using drugs'"|Generalized estimation|||||2.15|1.24|<0.001
91724097|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.4|1.93||"At 3 months:~Parent-reported 'have asked your child about their thoughts and opinions about drinking alcohol and using drugs'"|Generalized estimation|||||1.93|1.40|<0.001
91724098|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.4||||0.003|TWO_SIDED|95.0|1.12|1.74||"At 18 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||1.74|1.12|0.003
91724099|NCT03925220|183342003|SUPERIORITY||Prevalence Ratio [PR]|1.38||||0.01|TWO_SIDED|95.0|1.06|1.78||"At 18 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.78|1.06|0.01
91489785|NCT01681472|182852190|OTHER||Correlation factor|0.36854||||0.369|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3690
91489786|NCT01681472|182852191|OTHER||Correlation factor|0.23512||||0.5751|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5751
91489787|NCT01681472|182852191|OTHER||Correlation factor|0.02576||||0.9672|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.9672
91705870|NCT01093651|183306232|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p\<0.04.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.04
91705871|NCT01093651|183306233|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p\<0.05 (not statistically significant)|Kruskal-Wallis|||Kruskal-Wallis non-parametric test of cell frequencies||||>0.05
91724100|NCT03188185|183342021|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05 .|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.99||0.128|TWO_SIDED|95.0|-3.5|0.4||ALK 5461 was compared to placebo using stage-specific MMRM for MADRS-10 Change from Baseline.Model-derived estimates were combined using equal weights|Mixed Models Analysis|||Analysis was conducted for each stage separately, and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2).||0.4|-3.5|0.128
91724101|NCT03301714|183342024|EQUIVALENCE|equivalence analysis|Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0||||baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold \<0.01)|Regression, Linear||Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.|||||.000
91724102|NCT04465955|183342027|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.4345|TWO_SIDED|95.0|-0.528|0.227|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q4W and Pooled Sham||0.227|-0.528|0.4345
91489788|NCT01681472|182852191|OTHER||Correlation factor|0.68778||||0.0594|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0594
91489789|NCT01681472|182852191|OTHER||Correlation factor|0.11512||||0.8281|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8281
91489790|NCT01681472|182852192|OTHER|||||||0.0451|||||||pearson|||||||0.0451
91489791|NCT01681472|182852193|OTHER||Correlation factor|0.42972||||0.3359|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.3359
91694191|NCT05870371|183283515|OTHER||Dependence coefficient (β)|-0.76|STANDARD_ERROR_OF_MEAN|1.32|=|0.564|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Physical Component Summary/PCS subscale of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.564
91694192|NCT05870371|183283515|OTHER||Dependence coefficient (β)|-3.05|STANDARD_ERROR_OF_MEAN|1.34|=|0.023|TWO_SIDED|||||The above p-value corresponds to Mental Component Summary/MCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline.The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mental Component Summary/MCS of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.023
91694193|NCT05870371|183283516|OTHER||||||=|0.014||||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||=0.014
91694194|NCT05870371|183283516|OTHER||Median Difference (Net)|1.0|||||TWO_SIDED|||||||||||||
91694195|NCT05870371|183283516|OTHER||Median Difference (Net)|2.0|||||TWO_SIDED|||||||||||||
91724103|NCT04465955|183342027|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.4217|TWO_SIDED|95.0|-0.536|0.225|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q8W and Pooled Sham||0.225|-0.536|0.4217
91724104|NCT04738487|183342041|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6712|TWO_SIDED|95.0|0.83|1.35||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.35|0.83|0.6712
91724105|NCT04738487|183342042|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.332|TWO_SIDED|95.0|0.82|1.13||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.13|0.82|0.3320
91724106|NCT04738487|183342043|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1646|TWO_SIDED|95.0|0.72|1.11||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.11|0.72|0.1646
91724107|NCT04253626|183342094|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||< 0.001
91489792|NCT01681472|182852193|OTHER||Correlation factor|0.75404||||0.0307|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.0307
91489793|NCT01681472|182852193|OTHER||Correlation factor|-0.7073||||0.116|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.1160
91489794|NCT01681472|182852193|OTHER||Correlation factor|-0.47193||||0.2377|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.2377
91489795|NCT01681472|182852193|OTHER||Correlation factor|0.88128||||0.0087|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0087
91489796|NCT01681472|182852193|OTHER||Correlation factor|0.58502||||0.1277|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.1277
91694196|NCT04495751|183283556|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|90.0|-3.5|1.1||||||||1.1|-3.5|
91694197|NCT04495751|183283557|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||||0.1|-0.5|
91694198|NCT04495751|183283558|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.7|2.0||||||||2.0|-0.7|
91694199|NCT04495751|183283559|SUPERIORITY||Mean Difference (Final Values)|-973.5|||||TWO_SIDED|95.0|-3500.0|1553.0||||||||1553|-3500|
91694200|NCT04495751|183283560|SUPERIORITY||Mean Difference (Final Values)|20.7|||||TWO_SIDED|95.0|-32.4|73.8||||||||73.8|-32.4|
91694201|NCT04495751|183283561|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.2|3.2||||||||3.2|-2.2|
91694202|NCT04495751|183283562|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.7||||||Quality of Life - Self-rate health||0.7|-0.2|
91694203|NCT04495751|183283562|SUPERIORITY|Quality of life - Ability to carry out social activities and roles|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.3|0.6||||||||0.6|-0.3|
91694204|NCT04495751|183283562|SUPERIORITY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-2.7|4.5||||||Physical health (t score)||4.5|-2.7|
91694205|NCT04495751|183283562|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.4|2.5||||||Global Mental health (t score||2.5|-5.4|
91694206|NCT04495751|183283563|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-99.7|101.9||||||||101.9|-99.7|
91694207|NCT04495751|183283564|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
91694208|NCT00708461|183283565|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.1202||0.36|TWO_SIDED|95.0|-0.21|0.46||Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.|ANCOVA|Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.||"The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:~* Intraclass correlation (ICC) of 0.016, estimated from an earlier study~* Variance of 118 kg, estimated from an earlier study~* Cohort N=400~* 15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20."||0.46|-0.21|0.36
91694209|NCT02907177|183283566|SUPERIORITY||Treatment effect (rate ratio)|1.27||||0.5252|TWO_SIDED|95.0|0.608|2.654|||Negative binomial regression||Rate ratio is ponesimod 20 mg / DMF versus placebo /DMF|||2.654|0.608|0.5252
91694210|NCT01637922|183283631|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|118.12|STANDARD_DEVIATION|15.4||0.1638|TWO_SIDED|90.0|107.06|130.32||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||130.32|107.06|0.1638
91694211|NCT01637922|183283632|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|114.08|STANDARD_DEVIATION|13.2||0.0391|TWO_SIDED|90.0|104.812|124.164||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||124.164|104.812|0.0391
91694212|NCT01637922|183283633|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.79|STANDARD_DEVIATION|18.7||0.0603|TWO_SIDED|90.0|99.243|125.922||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||125.922|99.243|0.0603
91694213|NCT01637922|183283634|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|117.65|STANDARD_DEVIATION|15.0||0.1424|TWO_SIDED|90.0|106.89|129.5||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||129.50|106.89|0.1424
91694214|NCT01637922|183283635|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.46|STANDARD_DEVIATION|16.3||0.0367|TWO_SIDED|90.0|100.42|123.715||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||123.715|100.420|0.0367
91694215|NCT01637922|183283636|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.52|STANDARD_DEVIATION|17.7||0.0488|TWO_SIDED|90.0|99.577|124.888||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||124.888|99.577|0.0488
91694216|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.01098|||||TWO_SIDED|95.0|-0.189801|0.16864||||||Pearson correlation of trough concentrations of R-methadone and OOWS||0.168640|-0.189801|
91694217|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.10188|||||TWO_SIDED|95.0|-0.287471|0.092062||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS||0.092062|-0.287471|
91694218|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03198|||||TWO_SIDED|95.0|-0.209893|0.148238||||||Pearson correlation of trough concentrations of S-methadone and OOWS||0.148238|-0.209893|
91694219|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0026|||||TWO_SIDED|95.0|-0.189172|0.194156||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS||0.194156|-0.189172|
91694220|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03364|||||TWO_SIDED|95.0|-0.214505|0.149733||||||Pearson correlation of trough concentrations of Buprenorphine and OOWS||0.149733|-0.214505|
91694221|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.14703|||||TWO_SIDED|95.0|-0.404929|0.135425||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS||0.135425|-0.404929|
91694222|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05431|||||TWO_SIDED|95.0|-0.240578|0.136305||||||Pearson correlation of trough concentrations of norbuprenorphine and OOWS||0.136305|-0.240578|
91694223|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.09727|||||TWO_SIDED|95.0|-0.344024|0.163687||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS||0.163687|-0.344024|
91489797|NCT01681472|182852193|OTHER||Correlation factor|0.89976||||0.0146|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0146
91694224|NCT01637922|183283637|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.36105|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and OOWS||||
91694225|NCT01637922|183283638|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.71|STANDARD_DEVIATION|36.1||0.1642|TWO_SIDED|90.0|85.14|138.8||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||138.80|85.14|0.1642
91694226|NCT01637922|183283639|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|92.43|STANDARD_DEVIATION|33.7||0.142|TWO_SIDED|90.0|73.48|116.27||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||116.27|73.48|0.1420
91694227|NCT01637922|183283640|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.36|STANDARD_DEVIATION|38.1||0.1915|TWO_SIDED|90.0|81.611|143.883||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||143.883|81.611|0.1915
91694228|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04783|||||TWO_SIDED|95.0|-0.13275|0.224946||||||Pearson correlation of trough concentrations of R-methadone and SOWS||0.224946|-0.132750|
91694229|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.39865|||||TWO_SIDED|95.0|-0.547072|-0.222288||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS||-0.222288|-0.547072|
91694230|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.11175|||||TWO_SIDED|95.0|-0.069336|0.284848||||||Pearson correlation of trough concentrations of S-methadone and SOWS||0.284848|-0.069336|
91694231|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.16815|||||TWO_SIDED|95.0|-0.34787|0.025107||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS||0.025107|-0.347870|
91694232|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0126|||||TWO_SIDED|95.0|-0.17016|0.194417||||||Pearson correlation of trough concentrations of Buprenorphine and SOWS||0.194417|-0.170160|
91694233|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.02352|||||TWO_SIDED|95.0|-0.253932|0.29696||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS||0.296960|-0.253932|
91694234|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05787|||||TWO_SIDED|95.0|-0.24392|0.132819||||||Pearson correlation of trough concentrations of norbuprenorphine and SOWS||0.132819|-0.243920|
91694235|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04052|||||TWO_SIDED|95.0|-0.218159|0.293233||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS||0.293233|-0.218159|
91694236|NCT01637922|183283641|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.92231|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and SOWS||||
91694237|NCT01637922|183283642|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|138.0|STANDARD_DEVIATION|50.7||0.6889|TWO_SIDED|90.0|97.2|195.92||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||195.92|97.20|0.6889
91694238|NCT01637922|183283643|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|132.86|STANDARD_DEVIATION|51.1||0.6188|TWO_SIDED|90.0|93.32|189.16||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||189.16|93.32|0.6188
91724108|NCT04253626|183342098|OTHER|||||||0.88||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.88
91489798|NCT01681472|182852193|OTHER||Correlation factor|0.11497||||0.7863|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.7863
91724109|NCT04253626|183342099|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance was \< 0.05.||Between-group analysis of change at week 4||||0.27
91724110|NCT04253626|183342100|OTHER|||||||0.72||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.72
91724111|NCT04253626|183342101|OTHER|||||||0.009||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.009
91724112|NCT01022580|183342130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|TWO_SIDED||||||unadj GEE|||||||0.89
91724113|NCT01022580|183342131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||unadj GEE|||||||0.33
91724114|NCT03720847|183342149|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.012|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|||||.012
91489799|NCT01681472|182852193|OTHER||Correlation factor|0.97624||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0002
91489800|NCT01681472|182852193|OTHER||Correlation factor|0.88682||||0.0033|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0033
91724115|NCT03720847|183342150|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.03|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates a greater perimenstrual increase in the outcome in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.030
91724116|NCT03720847|183342151|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.013|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.013
91724117|NCT03720847|183342152|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.018|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual change in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.018
91724118|NCT03720847|183342153|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.073|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.073
91724119|NCT03720847|183342154|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.25|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.25
91724120|NCT03720847|183342155|SUPERIORITY||Mean Difference (Final Values)|-1.32||||0.23|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.23
91724121|NCT01500096|183342156|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.15
91724122|NCT01500096|183342156|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms||||0.73
91724123|NCT01500096|183342157|SUPERIORITY|||||||0.1329|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1329
91724124|NCT01500096|183342157|SUPERIORITY|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1191
91724125|NCT01500096|183342158|SUPERIORITY|||||||0.7454|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7454
91724126|NCT01500096|183342158|SUPERIORITY|||||||0.7391|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7391
91724127|NCT01500096|183342159|SUPERIORITY|||||||0.6818|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.6818
91724128|NCT01500096|183342159|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.0579
91489801|NCT01681472|182852193|OTHER||Correlation factor|-0.64743||||0.1645|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.1645
91724129|NCT01500096|183342160|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.17
91724130|NCT01500096|183342160|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.51
91724131|NCT01500096|183342161|SUPERIORITY|||||||0.7884|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7884
91724132|NCT01500096|183342161|SUPERIORITY|||||||0.5532|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.5532
91724133|NCT01500096|183342162|SUPERIORITY|||||||0.9885|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.9885
91724134|NCT01500096|183342162|SUPERIORITY|||||||0.2898|||||||Wilcoxon (Mann-Whitney)|2 sides Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.2898
91724135|NCT01500096|183342163|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.60
91724136|NCT01500096|183342163|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.28
91724137|NCT01500096|183342163|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.41
91724138|NCT01500096|183342163|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.72
91724139|NCT01500096|183342163|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.34
91724140|NCT01500096|183342163|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.58
91724141|NCT01500096|183342164|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 5 are significantly different between arms.||||0.31
91724142|NCT01500096|183342164|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.71
91724143|NCT01500096|183342165|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.18
91489802|NCT01681472|182852193|OTHER||Correlation factor|0.17664||||0.6756|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.6756
91489803|NCT01681472|182852193|OTHER||Correlation factor|0.94364||||0.0014|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0014
91694239|NCT01637922|183283644|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|112.03|STANDARD_DEVIATION|52.5||0.3152|TWO_SIDED|90.0|74.85|167.67||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||167.67|74.85|0.3152
91694240|NCT01637922|183283645|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|98.94|STANDARD_DEVIATION|19.6||0.0107|TWO_SIDED|90.0|85.81|114.076||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.076|85.810|0.0107
91694241|NCT01637922|183283646|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|94.33|STANDARD_DEVIATION|27.6||0.0738|TWO_SIDED|90.0|78.017|114.054||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.054|78.017|0.0738
91694242|NCT00638404|183283648|OTHER|correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|anxiety to evoked pain is 0.24 (P\<.001); anticipated pain to evoked pain is 0.33 (P\<.001); anticipated pain medication to evoked pain is 0.33(P\<.001).||||||<.001
91694243|NCT00638404|183283648|OTHER|correlation of anxiety to evoked pain at 24 hour|||||<|0.001|||||||Spearman Correlation|||||||<.001
91694244|NCT00638404|183283648|OTHER|correlation of anticipated pain medication 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
91694245|NCT00638404|183283648|OTHER|correlation of anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
91694246|NCT00638404|183283649|OTHER||||||<|0.001|||||||Spearman Correlation|||preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible||||<.001
91694247|NCT00638404|183283650|OTHER||||||<|0.001|||||||Spearman Correlation|||||||<.001
91694248|NCT00638404|183283651|OTHER|Correlation of|||||<|0.001|||||||Spearman Correlation|||||||<.001
91694249|NCT00459290|183283657|SUPERIORITY_OR_OTHER|||||||0.7912|||||||Log Rank|||||||0.7912
91694250|NCT00459290|183283658|SUPERIORITY_OR_OTHER|||||||0.1545|||||||Log Rank|||||||0.1545
91694251|NCT00459290|183283659|SUPERIORITY_OR_OTHER|||||||0.0648|||||||Log Rank|||||||0.0648
91694252|NCT00687271|183283660|OTHER||Difference in Percentage Change|-10.0|||||TWO_SIDED|95.0|-14.6|-5.5|||Longitudinal Data Analysis (LDA) model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-5.5|-14.6|
91694253|NCT00687271|183283660|OTHER||Difference in Percentage Change|-17.9|||||TWO_SIDED|95.0|-23.4|-12.5|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-12.5|-23.4|
91694254|NCT00687271|183283663|OTHER||Difference in Percentage Change|-8.6|||||TWO_SIDED|95.0|-12.7|-4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.4|-12.7|
91694255|NCT00687271|183283663|OTHER||Diffence in Percentage Change|-13.9|||||TWO_SIDED|95.0|-18.9|-8.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-8.9|-18.9|
91724144|NCT01500096|183342165|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.19
91489804|NCT01681472|182852193|OTHER||Correlation factor|0.43194||||0.2852|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2852
91489805|NCT01681472|182852193|OTHER||Correlation factor|0.58419||||0.2234|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2234
91694256|NCT00687271|183283664|OTHER||Difference in Percentage Change|-7.7|||||TWO_SIDED|95.0|-11.5|-3.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-3.9|-11.5|
91694257|NCT00687271|183283664|OTHER||Difference in Percentage Change|-12.2|||||TWO_SIDED|95.0|-16.8|-7.6|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.6|-16.8|
91694258|NCT00687271|183283665|OTHER||Difference in Percentage Change|-7.4|||||TWO_SIDED|95.0|-10.8|-4.1|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.1|-10.8|
91694259|NCT00687271|183283665|OTHER||Difference in Percentage Change|-11.0|||||TWO_SIDED|95.0|-15.1|-7.0|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.0|-15.1|
91694260|NCT00687271|183283666|OTHER||Dfferecne in Percentage Change|-2.4|||||TWO_SIDED|95.0|-6.6|1.8|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||1.8|-6.6|
91694261|NCT00687271|183283666|OTHER||Difference in Percentage Change|-0.7|||||TWO_SIDED|95.0|-5.8|4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||4.4|-5.8|
91694262|NCT00687271|183283667|OTHER||Difference in Percentage Change|-1.0|||||TWO_SIDED|95.0|-7.7|5.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||5.9|-7.7|
91724145|NCT01500096|183342166|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.47
91489806|NCT01681472|182852193|OTHER||Correlation factor|0.9584||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0002
91724146|NCT01500096|183342166|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.41
91489807|NCT01681472|182852193|OTHER||Correlation factor|-0.38987||||0.3873|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.3873
91489808|NCT01681472|182852193|OTHER||Correlation factor|-0.25891||||0.5358|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.5358
91489809|NCT01681472|182852193|OTHER||Correlation factor|0.777||||0.0691|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.0691
91489810|NCT01681472|182852193|OTHER||Correlation factor|0.00322||||0.994|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.9940
91489811|NCT01681472|182852193|OTHER||Correlation factor|0.93711||||0.0018|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0018
91489812|NCT01681472|182852193|OTHER||Correlation factor|0.46883||||0.2413|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.2413
91489813|NCT01681472|182852193|OTHER||Correlation factor|-0.09737||||0.8544|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.8544
91694263|NCT00687271|183283667|OTHER||Difference in Percentage Change|5.5|||||TWO_SIDED|95.0|-4.6|16.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||16.9|-4.6|
91694264|NCT02110758|183283690|OTHER|||||||0.025|||||||Regression, Logistic|||To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.025
91489814|NCT01681472|182852193|OTHER||Correlation factor|0.78928||||0.0199|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0199
91694265|NCT02110758|183283690|OTHER|||||||0.69|||||||Regression, Logistic|||To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.69
91694266|NCT02110758|183283690|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
91724147|NCT00924651|183342200|OTHER||Mean Difference (Final Values)|-0.01916|STANDARD_ERROR_OF_MEAN|0.1791||0.9148|TWO_SIDED|95.0|-0.371|0.3327|||ANCOVA|||||0.3327|-0.3710|0.9148
91724148|NCT00835978|183342203|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.578||||0.0189|TWO_SIDED|95.0|1.017|2.448||A priori defined threshold for statistical significance was: alpha=0.10 (one-sided)|Cochran-Mantel-Haenszel|||ORR for the 2 treatment arms was compared with the Cochran-Mantel-Haenszel test stratified by ECOG performance status. The relative risk ratio estimator was used to contrast the treatment effects on the endpoint. Both a point estimate and a 2-sided 95% CI were calculated using a normal approximation.||2.448|1.017|0.0189
91724149|NCT00835978|183342204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.849||||0.2444|TWO_SIDED|95.0|0.535|1.348|||Log Rank|||||1.348|0.535|0.2444
91724150|NCT02383173|183342235|OTHER|||||||0.445|||||||Generalized Estimating Equation (GEE)|Sandwich estimators were used to adjust for the small number of clusters.||Generalized Estimating Equation (GEE) analyses of post-intervention data were used to account for clustering. We adjusted for age, race, cancer, length of stay and study year.||||0.445
91724151|NCT00429299|183342256|NON_INFERIORITY_OR_EQUIVALENCE|An exploratory comparison between the combined two single anti-HER2 arms and the dual anti-HER2 arm was performed (Arm 3 versus Arms 1 and 2).|percentage of participants|25.0||||0.019||90.0|13.1|36.9||Exploratory analysis|Chi-squared||The estimated value represents the percentage of particpants in the CT plus trastuzumab treatment group with pathological complete response.|||36.9|13.1|0.019
91489815|NCT01681472|182852193|OTHER||Correlation factor|0.82963||||0.0209|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0209
91489816|NCT01681472|182852193|OTHER||Correlation factor|-0.16724||||0.6922|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.6922
91489817|NCT01681472|182852193|OTHER||Correlation factor|0.14436||||0.785|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.7850
91489818|NCT01681472|182852193|OTHER||Correlation factor|0.74757||||0.033|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0330
91489819|NCT01681472|182852193|OTHER||Correlation factor|0.32113||||0.4825|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.4825
91489820|NCT01681472|182852193|OTHER||Correlation factor|0.3716||||0.3647|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.3647
91489821|NCT01681472|182852193|OTHER||Correlation factor|0.20955||||0.6903|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.6903
91489822|NCT01681472|182852193|OTHER||Correlation factor|0.74459||||0.0341|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.0341
91489823|NCT01681472|182852193|OTHER||Correlation factor|0.50966||||0.2426|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.2426
91489824|NCT01681472|182852193|OTHER||Correlation factor|0.67853||||0.0643|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.0643
91489825|NCT01681472|182852193|OTHER||Correlation factor|0.05531||||0.9171|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.9171
91489826|NCT01681472|182852193|OTHER||Correlation factor|0.59183||||0.1222|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.1222
91489827|NCT01681472|182852193|OTHER||Correlation factor|0.8104||||0.0271|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0271
91489828|NCT01681472|182852193|OTHER||Correlation factor|0.86266||||0.0058|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0058
91489829|NCT01681472|182852193|OTHER||Correlation factor|-0.71666||||0.109|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1090
91694267|NCT02110758|183283690|OTHER|||||||0.85|||||||Regression, Logistic|||To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.85
91694268|NCT02110758|183283690|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
91694269|NCT02110758|183283690|OTHER|||||||0.053|||||||Regression, Logistic|||To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.053
91694270|NCT02110758|183283692|OTHER|||||||0.2|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Hospitalizations, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Hospitalizations. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.2
91694271|NCT02110758|183283692|OTHER|||||||0.62|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Emergency Department (ED) Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month ED Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.62
91694272|NCT02110758|183283692|OTHER|||||||0.68|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Primary Care Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Primary Care Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.68
91724152|NCT00429299|183342256|SUPERIORITY_OR_OTHER||percentage of participants|26.3||||||90.0|14.5|38.1|||||The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response.|||38.1|14.5|
91724153|NCT00429299|183342256|SUPERIORITY_OR_OTHER||percentage of participants|46.7|||||TWO_SIDED|90.0|34.4|58.9|||||The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response.|||58.9|34.4|
91694273|NCT02110758|183283692|OTHER|||||||0.03|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Specialist Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Specialist Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.03
91694274|NCT02074358|183283703|SUPERIORITY_OR_OTHER||mixed effect model|425.3|||<|0.001|TWO_SIDED|95.0|219.8|630.7|||Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||630.7|219.8|<0.001
91694275|NCT02074358|183283703|SUPERIORITY_OR_OTHER||mixed effect model|90.6||||0.131|TWO_SIDED|95.0|-31.3|212.4||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for any secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||212.4|-31.3|0.131
91694276|NCT02074358|183283704|SUPERIORITY_OR_OTHER||mixed effect model|-0.21||||0.389|TWO_SIDED|95.0|-0.73|0.3||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for other secondary endpoints since a non-significant treatment difference was observed for this first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|TGA Lag Time. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.30|-0.73|0.389
91724154|NCT04871113|183342273|OTHER||Emax|-1.848|||||TWO_SIDED|95.0|-2.225|-1.472|||||Emax is defined as maximum response.|||-1.472|-2.225|
91724155|NCT04871113|183342273|OTHER||EC50|68.578|||||TWO_SIDED|95.0|15.866|121.29|||||EC50 is defined as the dose (in mg) that attains the 50% of the maximal effect.|||121.290|15.866|
91724156|NCT04871113|183342273|OTHER||s2e|0.257|||||TWO_SIDED|95.0|0.145|0.368|||||e is defined as random error assumed to be normally distributed with mean zero and constant variance (s2).|||0.368|0.145|
91724157|NCT05630755|183342284|NON_INFERIORITY|A margin of 4 percentage points is used to define non-inferiority.|Risk Difference (RD)|0.88||||0.003|TWO_SIDED|95.0|-1.86|2.9|||Miettinen and Nurminen method|Unstratified Miettinen and Nurminen method was used|||The estimated difference was calculated using the unstratified Miettinen and Nurminen method.|2.90|-1.86|0.003
91724158|NCT05630755|183342284|SUPERIORITY||Risk Difference (RD)|0.88||||0.192|TWO_SIDED|95.0|-1.86|2.9|||Miettinen and Nurminen method|Unstratified Miettinen and Nurminen method was used|||The estimated difference was calculated using the unstratified Miettinen and Nurminen method.|2.90|-1.86|0.192
91724159|NCT04502524|183342303|OTHER|||||||0.999|||||||Fisher Exact|||For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.||||.999
91724160|NCT04502524|183342304|OTHER||Slope|0.05||||0.852|TWO_SIDED|95.0|-0.46|0.56|||Regression, negative binomial|||||0.56|-0.46|0.852
91724161|NCT04502524|183342305|OTHER||Slope|-0.44||||0.451|TWO_SIDED|95.0|-1.6|0.71|||Regression, negative binomial|||||0.71|-1.60|0.451
91724162|NCT04502524|183342306|OTHER||Slope|-0.73||||0.508|TWO_SIDED|95.0|-1.46|0.003|||Regression, negative binomial|||||0.003|-1.46|0.508
91724163|NCT04502524|183342307|OTHER||Odds Ratio (OR)|0.65||||0.602|TWO_SIDED|95.0|0.13|3.32|||Regression, Logistic|||||3.32|0.13|0.602
91489830|NCT01681472|182852193|OTHER||Correlation factor|0.55508||||0.1533|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1533
91724164|NCT04502524|183342308|OTHER||Odds Ratio (OR)|0.94||||0.941|TWO_SIDED|95.0|0.17|5.29|||Regression, Logistic|||||5.29|0.17|0.941
91724165|NCT04502524|183342309|OTHER||Odds Ratio (OR)|0.61||||0.612|TWO_SIDED|95.0|0.09|4.12|||Regression, Logistic|||||4.12|0.09|0.612
91724166|NCT04502524|183342310|OTHER||Slope|0.56||||0.504|TWO_SIDED|95.0|-1.13|2.26|||Regression, Linear|||||2.26|-1.13|0.504
91724167|NCT04502524|183342311|OTHER||Slope|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.61|||Regression, Linear|||||0.61|-0.40|0.670
91724168|NCT02965456|183342375|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
91724169|NCT02965456|183342376|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
91724170|NCT02965456|183342377|SUPERIORITY|||||||0.007||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||0.007
91724171|NCT05073315|183342380|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Ratio Geometric Least Square Mean (GMR)|1.0516|||||TWO_SIDED|90.0|0.901|1.2273||||||||1.2273|0.9010|
91724172|NCT05073315|183342381|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Least Square Mean Ratio|1.0044|||||TWO_SIDED|90.0|0.8717|1.1574||||||||1.1574|0.8717|
91724173|NCT05073315|183342384|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean Difference (Final Values)|-2.47|||||TWO_SIDED|90.0|-5.23|0.29||||||||0.29|-5.23|
91724174|NCT01529268|183342391|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.8|2.1|||Cochran-Mantel-Haenszel|||||2.1|0.8|0.34
91724175|NCT01529268|183342392|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.90
91724176|NCT01529268|183342393|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.7||||0.15|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Steatosis: patients with improvement||1.1|0.5|0.15
91724177|NCT01529268|183342394|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.59|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Steatosis: change in score||0.4|-0.2|0.59
91724178|NCT01529268|183342395|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.8||||0.03|TWO_SIDED|95.0|1.1|2.9|||Cochran-Mantel-Haenszel|||||2.9|1.1|0.03
91724179|NCT01529268|183342396|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.06|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.06
91724180|NCT01529268|183342397|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.8||||0.29|TWO_SIDED|95.0|0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|0.4|0.29
91724181|NCT01529268|183342398|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.15|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.15
91724182|NCT01529268|183342399|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.2||||0.57|TWO_SIDED|95.0|0.6|2.3|||Cochran-Mantel-Haenszel|||||2.3|0.6|0.57
91724183|NCT01529268|183342400|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.76
91724184|NCT01529268|183342401|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.6|||Cochran-Mantel-Haenszel|||||1.6|0.6|0.98
91724185|NCT01529268|183342402|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.24|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.24
91724186|NCT01529268|183342403|NON_INFERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|2.7||||0.29|TWO_SIDED|95.0|0.4|18.3|||Cochran-Mantel-Haenszel|Stratified by clinic and weight group||||18.3|0.4|0.29
91489831|NCT01681472|182852193|OTHER||Correlation factor|0.318||||0.487|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.4870
91489832|NCT01681472|182852193|OTHER||Correlation factor|0.23312||||0.5785|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.5785
91489833|NCT01681472|182852193|OTHER||Correlation factor|-0.0245||||0.9632|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.9632
91489834|NCT01681472|182852193|OTHER||Correlation factor|0.64565||||0.0838|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.0838
91694277|NCT02074358|183283704|SUPERIORITY_OR_OTHER||mixed effect model|-0.16||||0.142|TWO_SIDED|95.0|-0.38|0.06||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Lag Time. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.06|-0.38|0.142
91694278|NCT02074358|183283704|SUPERIORITY_OR_OTHER||mixed effect model|1.35||||0.2|TWO_SIDED|95.0|-0.81|3.52||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.52|-0.81|0.200
91694279|NCT02074358|183283704|SUPERIORITY_OR_OTHER||mixed effect model|4.62|||<|0.001|TWO_SIDED|95.0|2.8|6.44||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||6.44|2.80|<0.001
91694280|NCT02074358|183283705|SUPERIORITY_OR_OTHER||mixed effect model|21.1||||0.014|TWO_SIDED|95.0|4.9|37.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||37.2|4.9|0.014
91694281|NCT02074358|183283705|SUPERIORITY_OR_OTHER||mixed effect model|-6.4||||0.076|TWO_SIDED|95.0|-13.5|0.8||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.8|-13.5|0.076
91694282|NCT02074358|183283706|SUPERIORITY_OR_OTHER||mixed effect model|0.0||||0.996|TWO_SIDED|95.0|-5.6|5.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||5.6|-5.6|0.996
91694283|NCT02074358|183283706|SUPERIORITY_OR_OTHER||mixed effect model|-6.5|||<|0.001|TWO_SIDED|95.0|-9.5|-3.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-3.6|-9.5|<0.001
91489835|NCT01682954|182852199|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
91489836|NCT01682954|182852200|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
91489837|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 0.5 hour post-dose||3.64|-0.7|
91489838|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-5.13|-0.79||||||Inferential analysis at 1 hour post-dose||-0.79|-5.13|
91489839|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53||||||90.0|-7.7|-3.36||||||Inferential analysis at 2 hour post-dose||-3.36|-7.70|
91489840|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||||90.0|-1.77|2.57||||||Inferential analysis at 4 hour post-dose||2.57|-1.77|
91694284|NCT02074358|183283707|SUPERIORITY_OR_OTHER||mixed effect model|-1.64|||<|0.001|TWO_SIDED|95.0|-2.16|-1.12||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model that included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.12|-2.16|<0.001
91694285|NCT02074358|183283707|SUPERIORITY_OR_OTHER||mixed effect model|-1.47|||<|0.001|TWO_SIDED|95.0|-1.95|-0.99||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.99|-1.95|<0.001
91694286|NCT02074358|183283707|SUPERIORITY_OR_OTHER||mixed effect model|-2.59|||<|0.001|TWO_SIDED|95.0|-3.3|-1.89||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.89|-3.30|<0.001
91724187|NCT01529268|183342404|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks in serum alanine aminotransferase on treatment group and baseline value of serum alanine aminotransferase.|Adjusted difference in mean changes|-24.0||||0.02|TWO_SIDED|95.0|-44.0|-4.0|||ANCOVA|Adjusted for baseline serum alanine aminotransferase||Adjusted difference in mean changes in serum alanine aminotransferase (ALT). The change in ALT is adjusted for the baseline ALT value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-44|0.02
91489841|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||||90.0|-3.54|0.8||||||Inferential analysis at 8 hour post-dose||0.80|-3.54|
91489842|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||||90.0|-1.16|3.18||||||Inferential analysis at 12 hour post-dose||3.18|-1.16|
91694287|NCT02074358|183283707|SUPERIORITY_OR_OTHER||mixed effect model|-1.89|||<|0.001|TWO_SIDED|95.0|-2.59|-1.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.20|-2.59|<0.001
91694288|NCT02074358|183283707|SUPERIORITY_OR_OTHER||mixed effect model|8.47|||<|0.001|TWO_SIDED|95.0|6.29|10.66||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|aPTT. The ETP change from pre-PCC baseline was analyzed using a mixed effect model and included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||10.66|6.29|<0.001
91694289|NCT02074358|183283707|SUPERIORITY_OR_OTHER||mixed effect model|2.3|||<|0.001|TWO_SIDED|95.0|1.28|3.32||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|aPTT. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.32|1.28|<0.001
91694290|NCT02074358|183283708|SUPERIORITY_OR_OTHER||mixed effect model|-0.198|||<|0.001|TWO_SIDED|95.0|-0.266|-0.13||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.130|-0.266|<0.001
91489843|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||||90.0|-2.81|1.53||||||Inferential analysis at 24 hour post-dose||1.53|-2.81|
91489844|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49||||||90.0|0.32|4.66||||||Inferential analysis at 0.5 hour post-dose||4.66|0.32|
91489845|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||||90.0|-3.95|0.39||||||Inferential analysis at 1 hour post-dose||0.39|-3.95|
91694291|NCT02074358|183283708|SUPERIORITY_OR_OTHER||mixed effect model|-0.17|||<|0.001|TWO_SIDED|95.0|-0.229|-0.111||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.111|-0.229|<0.001
91694292|NCT02074358|183283708|SUPERIORITY_OR_OTHER||mixed effect model|-0.239|||<|0.001|TWO_SIDED|95.0|-0.305|-0.173||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.173|-0.305|<0.001
91694293|NCT02074358|183283708|SUPERIORITY_OR_OTHER||mixed effect model|-0.176|||<|0.001|TWO_SIDED|95.0|-0.242|-0.11||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.110|-0.242|<0.001
91694294|NCT02074358|183283709|SUPERIORITY_OR_OTHER||mixed effect models|-0.239||||0.204|TWO_SIDED|95.0|-0.625|0.146||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.146|-0.625|0.204
91694295|NCT02074358|183283709|SUPERIORITY_OR_OTHER||mixed effect models|-0.17||||0.114|TWO_SIDED|95.0|-0.389|0.048||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.048|-0.389|0.114
91694296|NCT02074358|183283719|SUPERIORITY_OR_OTHER||mixed effect model|1.039|||||TWO_SIDED|90.0|0.972|1.111|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A, and Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.111|0.972|
91724188|NCT01529268|183342404|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in serum aspartate aminotransferase on treatment group and baseline value of serum aspartate aminotransferase.|Mean Difference (Net)|-15.0||||0.008|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA|Adjusted for baseline serum aspartate aminotransferase.||Adjusted difference in mean changes in serum aspartate aminotransferase (AST). The change in AST is adjusted for the baseline AST value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-26|0.008
91724189|NCT01529268|183342404|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in gamma-glutamyl transpeptidase on treatment group and baseline value of gamma-glutamyl transpeptidase.|Mean Difference (Net)|-7.0||||0.02|TWO_SIDED|95.0|-13.0|-1.0|||ANCOVA|Adjusted for baseline gamma-glutamyl transpeptidase||Adjusted difference in mean changes in serum gamma-glutamyl transpeptidase (GGT). The change in GGT is adjusted for the baseline GGTvalue; therefore, the adjusted difference in mean changes is not equal to the net change.||-1|-13|0.02
91489846|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||||90.0|-9.68|-5.34||||||Inferential analysis at 2 hour post-dose||-5.34|-9.68|
91489847|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.47||||||90.0|1.3|5.64||||||Inferential analysis at 4 hour post-dose||5.64|1.30|
91489848|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||||90.0|-1.04|3.3||||||Inferential analysis at 8 hour post-dose||3.30|-1.04|
91489849|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 12 hour post-dose||3.64|-0.70|
91694297|NCT02074358|183283719|SUPERIORITY_OR_OTHER||mixed effect model|1.021|||||TWO_SIDED|90.0|0.938|1.112|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.112|0.938|
91724190|NCT01529268|183342405|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-value and adjusted difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in weight (kg) on treatment group and baseline weight (kg).|Adjusted difference in mean changes|-1.5||||0.25|TWO_SIDED|95.0|-4.1|1.1|||ANCOVA|Adjusted for baseline weight (kg).||Adjusted difference in mean changes in weight (kg). The change in weight is adjusted for the baseline weight value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.1|-4.1|0.25
91724191|NCT01529268|183342406|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Adjusted difference in mean changes|-0.3||||0.42|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|Adjusted for baseline BMI (kg/m2)||Adjusted difference in mean changes in body mass index (BMI). The change in BMI is adjusted for the baseline BMI value; therefore, the adjusted difference in mean changes is not equal to the net change.||0.5|-1.1|0.42
91724192|NCT01529268|183342407|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Mean Difference (Net)|-0.1||||0.11|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|||||0.0|-0.1|0.11
91724193|NCT01529268|183342408|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in waist circumference on treatment group and baseline value of waist circumference.|Adjusted difference in mean changes|0.2||||0.89|TWO_SIDED|95.0|-2.3|2.6|||ANCOVA|Adjusted for baseline waist circumference (cm)||Adjusted difference in mean changes in waist circumference (cm). The change in waist circumference is adjusted for the baseline waist circumference value; therefore, the adjusted difference in mean changes is not equal to the net change.||2.6|-2.3|0.89
91724194|NCT01529268|183342409|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting serum glucose on treatment group and baseline fasting serum glucose value.|Adjusted difference in mean changes|-4.0||||0.24|TWO_SIDED|95.0|-11.0|3.0|||ANCOVA|Adjusted for baseline serum glucose value.||Adjusted difference in mean changes in fasting serum glucose. The change in fasting serum glucose is adjusted for the baseline fasting serum glucose value; therefore, the adjusted difference in mean changes is not equal to the net change.||3|-11|0.24
91724195|NCT01529268|183342410|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting insulin on treatment group and baseline fasting insulin.|Adjusted difference in mean changes|-6.0||||0.34|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Adjusted for baseline fasting insulin.||Adjusted difference in mean changes in fasting insulin. The change in fasting insulin is adjusted for the baseline fasting insulin value; therefore, the adjusted difference in mean changes is not equal to the net change.||6|-18|0.34
91724196|NCT01529268|183342411|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in HOMA-IR on treatment group and baseline HOMA-IR value.|Adjusted difference in mean changes|-2.6||||0.15|TWO_SIDED|95.0|-6.2|1.0|||ANCOVA|Adjusted for baseline HOMA-IR.||Adjusted difference in mean changes in HOMA-IR. The change in HOMA-IR is adjusted for the baseline HOMA-IR value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.0|-6.2|0.15
91724197|NCT01529268|183342412|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in systolic blood pressure on treatment group and baseline systolic blood pressure value.|Adjusted difference in mean changes|1.0||||0.71|TWO_SIDED|95.0|-3.0|4.0|||ANCOVA|Adjusted for baseline systolic blood pressure.||Adjusted difference in mean changes in systolic blood pressure. The change in systolic blood pressure is adjusted for the baseline systolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||4|-3|0.71
91724198|NCT01529268|183342413|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in diastolic blood pressure on treatment group and baseline diastolic blood pressure value.|Adjusted difference in mean changes|-1.0||||0.31|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|Adjusted for baseline diastolic blood pressure.||Adjusted difference in mean changes in diastolic blood pressure. The change in diastolic blood pressure is adjusted for the baseline diastolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||1|-4|0.31
91759986|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-10.32|8.94||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.94|-10.32|
91489850|NCT00795145|182852207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||||90.0|-0.37|3.97||||||Inferential analysis at 24 hour post-dose||3.97|-0.37|
91694298|NCT02074358|183283721|SUPERIORITY_OR_OTHER||mixed effect model|1.019|||||TWO_SIDED|90.0|0.955|1.087|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A). No adjustment was made for multiplicity.||1.087|0.955|
91489851|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||||90.0|1.1|5.44||||||Inferential analysis at 0.5 hour post-dose||5.44|1.10|
91489852|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|4.66|9.0||||||Inferential analysis at 1 hour post-dose||9.00|4.66|
91528000|NCT03662997|182931041|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.56||||||Five-layer vs Hydrocellular arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.56
91694299|NCT02074358|183283721|SUPERIORITY_OR_OTHER||mixed effect model|1.018|||||TWO_SIDED|90.0|0.94|1.102|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.102|0.940|
91694300|NCT01164579|183283738|SUPERIORITY_OR_OTHER||Difference in least squares (LS) Mean|-0.63|STANDARD_ERROR_OF_MEAN|0.57||0.2696|TWO_SIDED|90.0|-1.58|0.31||2-sided p-value; alpha equals (=) 0.10|mixed model repeated measures analysis|||||0.31|-1.58|0.2696
91694301|NCT01164579|183283738|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.57||0.3561|TWO_SIDED|90.0|-1.46|0.41||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||||0.41|-1.46|0.3561
91694302|NCT01164579|183283739|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.55|STANDARD_ERROR_OF_MEAN|0.59||0.0089|TWO_SIDED|90.0|-2.52|-0.58||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.58|-2.52|0.0089
91694303|NCT01164579|183283739|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.74|STANDARD_ERROR_OF_MEAN|0.59||0.0038|TWO_SIDED|90.0|-2.72|-0.76||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.76|-2.72|0.0038
91694304|NCT01164579|183283740|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.57||0.6576|TWO_SIDED|90.0|-1.19|0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.69|-1.19|0.6576
91694305|NCT01164579|183283740|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.7565|TWO_SIDED|90.0|-1.09|0.74||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.74|-1.09|0.7565
91694306|NCT01164579|183283740|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.94|STANDARD_ERROR_OF_MEAN|0.58||0.1038|TWO_SIDED|90.0|-1.89|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.01|-1.89|0.1038
91694307|NCT01164579|183283740|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.59||0.0868|TWO_SIDED|90.0|-1.98|-0.04||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.04|-1.98|0.0868
91694308|NCT01164579|183283740|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.62||0.0103|TWO_SIDED|90.0|-2.62|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-2.62|0.0103
91694309|NCT01164579|183283740|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.53|0.55||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.55|-1.53|0.4350
91694310|NCT01164579|183283741|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.489|TWO_SIDED|90.0|-1.36|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.56|-1.36|0.4890
91694311|NCT01164579|183283741|SUPERIORITY_OR_OTHER||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.57||0.8817|TWO_SIDED|90.0|-0.85|1.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||1.02|-0.85|0.8817
91694312|NCT01164579|183283741|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.24|STANDARD_ERROR_OF_MEAN|0.59||0.0351|TWO_SIDED|90.0|-2.21|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.27|-2.21|0.0351
91694313|NCT01164579|183283741|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.32|STANDARD_ERROR_OF_MEAN|0.58||0.0231|TWO_SIDED|90.0|-2.28|-0.37||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.37|-2.28|0.0231
91694314|NCT01164579|183283741|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.62||0.0008|TWO_SIDED|90.0|-3.13|-1.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.08|-3.13|0.0008
91694315|NCT01164579|183283741|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.63||0.0003|TWO_SIDED|90.0|-3.32|-1.25||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.25|-3.32|0.0003
91694316|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2689|TWO_SIDED|90.0|-0.96|0.19||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.19|-0.96|0.2689
91489853|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.27||||||90.0|8.1|12.44||||||Inferential analysis at 2 hour post-dose||12.44|8.10|
91694317|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9935|TWO_SIDED|90.0|-0.58|0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.57|-0.58|0.9935
91694318|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.35||0.1086|TWO_SIDED|90.0|-1.15|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.01|-1.15|0.1086
91694319|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8092|TWO_SIDED|90.0|-0.66|0.49||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.49|-0.66|0.8092
91694320|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.35||0.0463|TWO_SIDED|90.0|-1.29|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.12|-1.29|0.0463
91694321|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.0624|TWO_SIDED|90.0|-1.25|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.25|0.0624
91694322|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.37||0.0005|TWO_SIDED|90.0|-1.9|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.69|-1.90|0.0005
91694323|NCT01164579|183283742|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.26|STANDARD_ERROR_OF_MEAN|0.37||0.0008|TWO_SIDED|90.0|-1.87|-0.65||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.65|-1.87|0.0008
91694324|NCT01164579|183283743|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
91694325|NCT01164579|183283743|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
91694326|NCT01164579|183283743|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
91694327|NCT01164579|183283743|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27|||mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
91694328|NCT01164579|183283744|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
91489854|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84||||||90.0|7.67|12.01||||||Inferential analysis at 4 hour post-dose||12.01|7.67|
91489855|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||||90.0|7.23|11.58||||||Inferential analysis at 8 hour post-dose||11.58|7.23|
91489856|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||||90.0|4.87|9.22||||||Inferential analysis at 12 hour post-dose||9.22|4.87|
91694329|NCT01164579|183283744|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
91694330|NCT01164579|183283744|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
91694331|NCT01164579|183283744|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
91694332|NCT01164579|183283745|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
91724199|NCT01529268|183342414|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in self-reported Physical Health summary score on treatment group and baseline value of the Physical Health summary score.|Adjusted difference in mean changes|-1.0||||0.77|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline self-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in self-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Physical Health summary score is adjusted for the baseline Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.77
91694333|NCT01164579|183283745|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
91694334|NCT01164579|183283745|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
91724200|NCT01529268|183342414|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in Pyschosocial Health summary score on treatment group and baseline Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.64|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline Psychosocial Health summary score.||Adjusted difference in mean changes from baseline in self-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Psychosocial Health summary score is adjusted for the baseline Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.64
91724201|NCT01529268|183342414|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Physical Health summary score on treatment group and baseline value of the parent/guardian-reported Physical Health summary score.|Adjusted difference in mean changes|-2.0||||0.58|TWO_SIDED|95.0|-9.0|5.0|||ANCOVA|Adjusted for baseline parent/guardian-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in parent/guardian-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Physical Health summary score is adjusted for the baseline parent/guardian-reported Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-9|0.58
91724202|NCT01529268|183342414|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Psychosocial Health summary score on treatment group and baseline value of the parent/guardian-reported Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.85|TWO_SIDED|95.0|-6.0|5.0|||ANCOVA|||Adjusted difference in mean changes from baseline in parent/guardian-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Psychosocial Health summary score is adjusted for the baseline parent/guardian-reported Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-6|0.85
91724203|NCT01529268|183342415|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
91724204|NCT02232698|183342422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.239|<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91724205|NCT02232698|183342423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9556|TWO_SIDED||||||ANCOVA|||||||0.9556
91724206|NCT02232698|183342424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.175|<|0.0001|TWO_SIDED|||||Statistical analysis of time spent \<55 mg/dL|ANCOVA|||||||<0.0001
91724207|NCT02232698|183342424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.122||0.0003|TWO_SIDED|||||Statistical analysis of time spent \<40 mg/dL|ANCOVA|||||||0.0003
91724208|NCT02232698|183342425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||<0.0001
91724209|NCT02232698|183342425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||<0.0001
91724210|NCT02232698|183342425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<40 mg/dL||||<0.0001
91489857|NCT00795145|182852208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.52||||||90.0|4.35|8.69||||||Inferential analysis at 24 hour post-dose||8.69|4.35|
91724211|NCT02232698|183342426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.329||0.5623|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5623
91724212|NCT02232698|183342426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.163||0.0247|TWO_SIDED||||||ANCOVA|||Statistical analysis for time spent \>240 mg/dL||||0.0247
91724213|NCT02232698|183342427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0006|TWO_SIDED||||||ANCOVA|||||||0.0006
91724214|NCT02232698|183342430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hyperglycaemia||||<0.0001
91724215|NCT02232698|183342430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0713|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hypoglycaemia||||0.0713
91724216|NCT02232698|183342430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of total treatment satisfaction score||||<0.0001
91724217|NCT01068912|183342445|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||A step-down approach was applied to the primary analysis, with the higher dose of favipiravir first tested against placebo.|Gehan-Wilcoxon|||Time required from first study drug administration to alleviation of the 6 primary influenza symptoms and fever. The primary influenza symptoms included cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Symptoms were considered alleviated when all were decreased to ≤1 and decrease persisted unchanged ≥ 21.5 hours. Fever was considered alleviated when maintained at \< 38.0°C (age 20 to \< 65 years) or \< 37.8°C (age ≥ 65 years) ≥ 21.5 hours.||||.05
91489858|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||||90.0|-5.54|2.57||||||Inferential analysis at 0.5 hour post-dose||2.57|-5.54|
91489859|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.45||||||90.0|-11.51|-3.4||||||Inferential analysis at 1 hour post-dose||-3.40|-11.51|
91489860|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.75||||||90.0|-9.81|-1.7||||||Inferential analysis at 2 hour post-dose||-1.70|-9.81|
91489861|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||||90.0|-4.97|3.13||||||Inferential analysis at 4 hour post-dose||3.13|-4.97|
91694335|NCT01164579|183283745|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
91489862|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64||||||90.0|-9.69|-1.58||||||Inferential analysis at 8 hour post-dose||-1.58|-9.69|
91694336|NCT01164579|183283746|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
91694337|NCT01164579|183283746|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
91694338|NCT01164579|183283746|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
91694339|NCT01164579|183283746|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
91694340|NCT01164579|183283747|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
91694341|NCT01164579|183283747|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
91694342|NCT01164579|183283747|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
91694343|NCT01164579|183283747|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
91694344|NCT01164579|183283748|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
91694345|NCT01164579|183283748|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
91694346|NCT01164579|183283748|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
91694347|NCT01164579|183283748|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
91694348|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.12|STANDARD_ERROR_OF_MEAN|11.24||0.243|TWO_SIDED|90.0|-5.36|31.62|||Normal approximation to the binomial|||Month 1||31.62|-5.36|0.2430
91694349|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 1||45.90|8.91|0.0147
91694350|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.03|STANDARD_ERROR_OF_MEAN|11.25||0.0127|TWO_SIDED|90.0|9.51|46.54|||Normal approximation to the binomial|||Month 2||46.54|9.51|0.0127
91694351|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.57|STANDARD_ERROR_OF_MEAN|11.45||0.0724|TWO_SIDED|90.0|1.73|39.41|||Normal approximation to the binomial|||Month 2||39.41|1.73|0.0724
91694352|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.49|STANDARD_ERROR_OF_MEAN|10.85||0.0086|TWO_SIDED|90.0|10.63|46.35|||Normal approximation to the binomial|||Month 3||46.35|10.63|0.0086
91694353|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.46|STANDARD_ERROR_OF_MEAN|11.55||0.2808|TWO_SIDED|90.0|-6.54|31.47|||Normal approximation to the binomial|||Month 3||31.47|-6.54|0.2808
91694354|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 9||46.55|9.81|0.0115
91694355|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.09|STANDARD_ERROR_OF_MEAN|11.56||0.1921|TWO_SIDED|90.0|-3.94|34.12|||Normal approximation to the binomial|||Month 9||34.12|-3.94|0.1921
91694356|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 12||46.55|9.81|0.0115
91694357|NCT01164579|183283749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.86|STANDARD_ERROR_OF_MEAN|11.5||0.1203|TWO_SIDED|90.0|-1.05|36.79|||Normal approximation to the binomial|||Month 12||36.79|-1.05|0.1203
91489863|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||||90.0|-6.34|1.77||||||Inferential analysis at 12 hour post-dose||1.77|-6.34|
91489864|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||||90.0|-4.64|3.47||||||Inferential analysis at 24 hour post-dose||3.47|-4.64|
91489865|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49||||||90.0|-7.54|0.57||||||Inferential analysis at 0.5 hour post-dose||0.57|-7.54|
91694358|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
91724218|NCT04822194|183342446|SUPERIORITY|||||||0.053|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects require 36 per group.||||0.053
91724219|NCT04822194|183342447|SUPERIORITY|||||||0.741|||||||Mixed Models Analysis|Ran linear mixed models on natural log of RMSSD, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously obtained for within and between-subjects analyses of respiratory sinus arrhythmia data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects should be achieved with 36 per group.||||0.741
91724220|NCT04822194|183342448|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects a group by session interaction.||Null hypothesis: no difference between groups. Power analyses using a within-subject fMRI effect size estimate for right amygdala affective reactivity from a meta-analysis of Human Connectome Project data of approx. d=.70, applying to between-subjects effects as well, indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) to detect between-group effects should be achieved with 36 participants per group.||||0.021
91724221|NCT04822194|183342449|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|We ran linear mixed models, p-value reflects a group by session interaction for the UGRS composite scores.||Null hypothesis: no difference between groups. Power analyses of an effect size (d=.70) previously reported for within and between-subjects analyses of questionnaire outcomes (i.e., depressive symptoms, grief rumination, perceived stress, reappraisal usage) indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) for between-group effects should be achieved with 36 per group.||||0.724
91724222|NCT04822194|183342449|SUPERIORITY|||||||0.835|||||||Mixed Models Analysis|Ran linear mixed model on counterfactuals adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.835
91724223|NCT04822194|183342449|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Ran linear mixed model on injustice adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.090
91724224|NCT04822194|183342449|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|Ran linear mixed model on meaning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.983
91724225|NCT04822194|183342449|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Ran linear mixed model on reaction adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.760
91724226|NCT04822194|183342449|SUPERIORITY|||||||0.402|||||||Mixed Models Analysis|Ran linear mixed model on relations adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.402
91724227|NCT04822194|183342450|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|We ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.092
91489866|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.19||||||90.0|-16.24|-8.13||||||Inferential analysis at 1 hour post-dose||-8.13|-16.24|
91489867|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.39||||||90.0|-18.44|-10.33||||||Inferential analysis at 2 hour post-dose||-10.33|-18.44|
91489868|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||||90.0|-6.24|1.87||||||Inferential analysis at 4 hour post-dose||1.87|-6.24|
91724228|NCT04822194|183342451|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|Ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.585
91724229|NCT04822194|183342452|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Ran linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.70
91724230|NCT04822194|183342453|SUPERIORITY|||||||0.696|||||||Mixed Models Analysis|Ran linear mixed model on emotional problems adjusted for covariates, p-value above reflects group by session interaction||Null hypothesis: no difference between groups.||||0.696
91724231|NCT04822194|183342453|SUPERIORITY|||||||0.452|||||||Mixed Models Analysis|Ran linear mixed model on emotional well-being adjusted for covariates, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.452
91724232|NCT04822194|183342453|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|Ran a linear mixed model on energy adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.650
91724233|NCT04822194|183342453|SUPERIORITY|||||||0.224|||||||Mixed Models Analysis|Ran linear mixed model on general health perceptions adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.224
91724234|NCT04822194|183342453|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|Ran linear mixed model on pain adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference in groups||||0.256
91724235|NCT04822194|183342453|SUPERIORITY|||||||0.984|||||||Mixed Models Analysis|Ran linear mixed model on physical function adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.984
91724236|NCT04822194|183342453|SUPERIORITY|||||||0.363|||||||Mixed Models Analysis|Ran linear mixed model on physical health adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.363
91489869|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||||90.0|-2.95|5.15||||||Inferential analysis at 8 hour post-dose||5.15|-2.95|
91724237|NCT04822194|183342453|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|Ran linear mixed model on social functioning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.045
91489870|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||||90.0|-3.94|4.17||||||Inferential analysis at 12 hour post-dose||4.17|-3.94|
91694359|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
91694360|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.49|STANDARD_ERROR_OF_MEAN|10.37||0.0044|TWO_SIDED|90.0|12.43|46.56|||Normal approximation to the binomial|||Month 2||46.56|12.43|0.0044
91694361|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43|||Normal approximation to the binomial|||Month 2||33.43|0.79|0.0845
91694362|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.24|STANDARD_ERROR_OF_MEAN|11.0||0.0275|TWO_SIDED|90.0|6.14|42.35|||Normal approximation to the binomial|||Month 3||42.35|6.14|0.0275
91694363|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.67|STANDARD_ERROR_OF_MEAN|10.91||0.0186|TWO_SIDED|90.0|7.71|43.63|||Normal approximation to the binomial|||Month 3||43.63|7.71|0.0186
91694364|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.52|STANDARD_ERROR_OF_MEAN|10.75||0.0009|TWO_SIDED|90.0|17.82|53.22|||Normal approximation to the binomial|||Month 6||53.22|17.82|0.0009
91694365|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|STANDARD_ERROR_OF_MEAN|10.72||0.0169|TWO_SIDED|90.0|7.95|43.24|||Normal approximation to the binomial|||Month 6||43.24|7.95|0.0169
91694366|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 9||45.90|8.91|0.0147
91694367|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 9||33.11|-3.68|0.1882
91694368|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 12||45.90|8.91|0.0147
91694369|NCT01164579|183283750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 12||33.11|-3.68|0.1882
91694370|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57|STANDARD_ERROR_OF_MEAN|4.73||0.07|TWO_SIDED|90.0|0.78|16.35|||Normal approximation to the binomial|||Month 1||16.35|0.78|0.0700
91694371|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48|||Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
91694372|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.02|STANDARD_ERROR_OF_MEAN|8.68||0.0027|TWO_SIDED|90.0|11.73|40.3|||Normal approximation to the binomial|||Month 2||40.30|11.73|0.0027
91694373|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.81|STANDARD_ERROR_OF_MEAN|7.86||0.0324|TWO_SIDED|90.0|3.88|29.75|||Normal approximation to the binomial|||Month 2||29.75|3.88|0.0324
91694374|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.97||0.0969|TWO_SIDED|90.0|0.13|29.67|||Normal approximation to the binomial|||Month 3||29.67|0.13|0.0969
91694375|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96|STANDARD_ERROR_OF_MEAN|9.04||0.0606|TWO_SIDED|90.0|2.09|31.84|||Normal approximation to the binomial|||Month 3||31.84|2.09|0.0606
91694376|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.66|STANDARD_ERROR_OF_MEAN|10.49||0.2276|TWO_SIDED|90.0|-4.6|29.93|||Normal approximation to the binomial|||Month 6||29.93|-4.60|0.2276
91694377|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.93|STANDARD_ERROR_OF_MEAN|10.23||0.3827|TWO_SIDED|90.0|-7.9|25.76|||Normal approximation to the binomial|||Month 6||25.76|-7.90|0.3827
91694378|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|10.15||0.2177|TWO_SIDED|90.0|-4.18|29.2|||Normal approximation to the binomial|||Month 9||29.20|-4.18|0.2177
91694379|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12|||Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
91694380|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|9.8||0.8997|TWO_SIDED|90.0|-14.89|17.36|||Normal approximation to the binomial|||Month 12||17.36|-14.89|0.8997
91694381|NCT01164579|183283751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.71|STANDARD_ERROR_OF_MEAN|10.36||0.2587|TWO_SIDED|90.0|-5.34|28.76|||Normal approximation to the binomial|||Month 12||28.76|-5.34|0.2587
91489871|NCT00795145|182852209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||||90.0|-1.37|6.73||||||Inferential analysis at 24 hour post-dose||6.73|-1.37|
91694382|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|90.0|-0.56|0.13||||||Baseline||0.13|-0.56|
91694383|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.19|0.43||||||Baseline||0.43|-0.19|
91694384|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-1.38|-0.5||||||Month 1||-0.50|-1.38|
91694385|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|90.0|-1.01|-0.22||||||Month 1||-0.22|-1.01|
91694386|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.73|-0.7||||||Month 2||-0.70|-1.73|
91694387|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.2|-0.18||||||Month 2||-0.18|-1.20|
91694388|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|90.0|-1.33|-0.29||||||Month 3||-0.29|-1.33|
91694389|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|90.0|-0.94|0.12||||||Month 3||0.12|-0.94|
91694390|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.75|-0.61||||||Month 6||-0.61|-1.75|
91694391|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.73|-0.63||||||Month 6||-0.63|-1.73|
91694392|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.81|-0.61||||||Month 9||-0.61|-1.81|
91694393|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|90.0|-1.33|-0.13||||||Month 9||-0.13|-1.33|
91694394|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|90.0|-1.69|-0.51||||||Month 12||-0.51|-1.69|
91489872|NCT01696071|182852220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.038|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 QD - Tio R2.5 BID|No p-values are presented as no formal statistical hypothesis was tested.||0.034|-0.038|
91489873|NCT01696071|182852221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.021||||95.0|-0.032|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.052|-0.032|
91489874|NCT01696071|182852222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.05|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.022|-0.050|
91489875|NCT01696071|182852223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.051|0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.023|-0.051|
91489876|NCT01696071|182852224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||||95.0|-0.06|0.068|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.068|-0.060|
91489877|NCT01696071|182852225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.044|0.035|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.035|-0.044|
91489878|NCT01696071|182852226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.048|0.042|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.042|-0.048|
91489879|NCT01696071|182852227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.047|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.034|-0.047|
91694395|NCT01164579|183283752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|90.0|-1.51|-0.29||||||Month 12||-0.29|-1.51|
91489880|NCT01696071|182852228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.07|0.032|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.032|-0.070|
91489881|NCT01696071|182852229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.03|0.111|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.111|-0.030|
91489882|NCT01696071|182852230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.389|STANDARD_ERROR_OF_MEAN|3.658||||95.0|-8.651|5.873|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||5.873|-8.651|
91489883|NCT00739674|182852303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
91694396|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|90.0|-1.31|-0.45||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.45|-1.31|0.0010
91489884|NCT00739674|182852304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
91489885|NCT00739674|182852305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
91489886|NCT00739674|182852306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||95.0|||||Fisher Exact|||||||0.434
91489887|NCT00739674|182852307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.507
91489888|NCT00739674|182852308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.058
91489889|NCT00739674|182852309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.158
91489890|NCT00739674|182852310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.064
91489891|NCT00739674|182852311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.262
91489892|NCT00739674|182852312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.026
91489893|NCT00739674|182852313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0|||||Log Rank|||||||0.212
91489894|NCT02195583|182852325|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.||Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.||||<0.0001
91489895|NCT02195583|182852325|SUPERIORITY_OR_OTHER|||||||0.2274||95.0|||||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.||Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.||||0.2274
91694397|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.26||0.0102|TWO_SIDED|90.0|-1.1|-0.24||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.24|-1.10|0.0102
91694398|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|90.0|-1.52|-0.64||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.64|-1.52|<0.0001
91694399|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.27||0.0175|TWO_SIDED|90.0|-1.08|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.20|-1.08|0.0175
91694400|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.0125|TWO_SIDED|90.0|-1.13|-0.23||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.23|-1.13|0.0125
91694401|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.1457|TWO_SIDED|90.0|-0.84|0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.05|-0.84|0.1457
91694402|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.28||0.0003|TWO_SIDED|90.0|-1.48|-0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.57|-1.48|0.0003
91694403|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.28||0.0002|TWO_SIDED|90.0|-1.49|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.58|-1.49|0.0002
91694404|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|90.0|-1.63|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.69|-1.63|<0.0001
91694405|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.28||0.0196|TWO_SIDED|90.0|-1.14|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.20|-1.14|0.0196
91694406|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.3||0.0007|TWO_SIDED|90.0|-1.5|-0.52||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.52|-1.50|0.0007
91694407|NCT01164579|183283753|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.0049|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.35|-1.32|0.0049
91694408|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.53|0.15||||||Baseline||0.15|-0.53|
91694409|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|90.0|-0.24|0.36||||||Baseline||0.36|-0.24|
91694410|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|90.0|-1.4|-0.42||||||Month 1||-0.42|-1.40|
91694411|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|90.0|-1.01|-0.14||||||Month 1||-0.14|-1.01|
91694412|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|90.0|-1.82|-0.73||||||Month 2||-0.73|-1.82|
91694413|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.25|-0.13||||||Month 2||-0.13|-1.25|
91694414|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|90.0|-1.55|-0.38||||||Month 3||-0.38|-1.55|
91694415|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.12|0.11||||||Month 3||0.11|-1.12|
91694416|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|90.0|-2.13|-0.72||||||Month 6||-0.72|-2.13|
91694417|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||||TWO_SIDED|90.0|-1.91|-0.57||||||Month 6||-0.57|-1.91|
91694418|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 9||-0.39|-1.84|
91694419|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|90.0|-1.3|0.13||||||Month 9||0.13|-1.30|
91694420|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 12||-0.39|-1.84|
91694421|NCT01164579|183283754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|90.0|-1.43|0.11||||||Month 12||0.11|-1.43|
91694422|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.29||0.0046|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.35|-1.32|0.0046
91694423|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.29||0.0303|TWO_SIDED|90.0|-1.11|-0.15||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.15|-1.11|0.0303
91694424|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.18|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|90.0|-1.69|-0.68||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.68|-1.69|0.0001
91694425|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.3||0.0255|TWO_SIDED|90.0|-1.17|-0.18||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.18|-1.17|0.0255
91694426|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.3||0.0035|TWO_SIDED|90.0|-1.39|-0.39||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.39|-1.39|0.0035
91724238|NCT04822194|183342454|SUPERIORITY|||||||0.422|||||||ANCOVA|Ran a repeated measures ANCOVA of logged IL-6 serum, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.422
91724239|NCT04822194|183342454|SUPERIORITY|||||||0.438|||||||ANCOVA|Ran a repeated measures ANCOVA of TNFα, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.438
91724240|NCT01257438|183342489|SUPERIORITY_OR_OTHER||Greenwood's estimate of variance|0.59|||<|0.001|TWO_SIDED|95.0|0.44|0.79|||Log Rank|||Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||0.79|0.44|<0.001
91489896|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.595|TWO_SIDED|95.0|-1.84|3.2|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||3.20|-1.84|0.5950
91694427|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.3||0.0683|TWO_SIDED|90.0|-1.05|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.05|-1.05|0.0683
91694428|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|90.0|-1.81|-0.78||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.78|-1.81|<0.0001
91724241|NCT01257438|183342490|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).||||||0.007|TWO_SIDED||||||Farrington and Manning Exact Test|The non-inferiority margin is 0.075 (or 7.5%)||||||0.007
91694429|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.31||0.0006|TWO_SIDED|90.0|-1.59|-0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.56|-1.59|0.0006
91694430|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0004|TWO_SIDED|90.0|-1.67|-0.62||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.62|-1.67|0.0004
91694431|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.32||0.0706|TWO_SIDED|90.0|-1.1|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.05|-1.10|0.0706
91724242|NCT02965833|183342494|SUPERIORITY||||||=|0.0073|||||||Mixed Models Analysis|||||||=0.0073
91724243|NCT03976375|183342513|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4342|TWO_SIDED|95.0|0.78|1.23||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.23|0.78|0.4342
91724244|NCT03976375|183342514|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1563|TWO_SIDED|95.0|0.7|1.12||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.12|0.70|0.1563
91724245|NCT03976375|183342515|SUPERIORITY||Difference in Percentage vs Docetaxel|8.4||||0.01818|TWO_SIDED|95.0|0.5|16.3||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen and Nurminen method||Based on Miettinen \& Nurminen method stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50%)|||16.3|0.5|0.01818
91724246|NCT03976375|183342516|SUPERIORITY||Difference in Percentage vs Lenvatinib|10.2||||0.06009|TWO_SIDED|95.0|-3.1|19.9||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen & Nurminen method|||||19.9|-3.1|0.06009
91489897|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.93||||0.0002|TWO_SIDED|95.0|2.38|7.48|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||7.48|2.38|0.0002
91694432|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.13|STANDARD_ERROR_OF_MEAN|0.33||0.0008|TWO_SIDED|90.0|-1.67|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-1.67|0.0008
91724247|NCT03976375|183342520|OTHER||Difference in least squares means|-1.36||||0.4998|TWO_SIDED|95.0|-5.32|2.6|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||2.60|-5.32|0.4998
91724248|NCT03976375|183342521|OTHER||Difference in Least Squares Mean|-3.86||||0.1531|TWO_SIDED|95.0|-9.16|1.44|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||1.44|-9.16|0.1531
91724249|NCT03976375|183342522|OTHER||Difference in Least Squares Means|2.48||||0.3084|TWO_SIDED|95.0|-2.31|7.27|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, timing of anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.27|-2.31|0.3084
91694433|NCT01164579|183283755|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.33||0.0466|TWO_SIDED|90.0|-1.21|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.12|-1.21|0.0466
91694434|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.51|STANDARD_ERROR_OF_MEAN|11.04||0.0032|TWO_SIDED|90.0|14.34|50.68||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||50.68|14.34|0.0032
91694435|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||46.55|9.81|0.0115
91694436|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||50.02|18.81|0.0002
91694437|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.79|STANDARD_ERROR_OF_MEAN|10.48||0.0231|TWO_SIDED|90.0|6.55|41.03||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||41.03|6.55|0.0231
91694438|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||50.02|18.81|0.0002
91694439|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|10.69||0.0493|TWO_SIDED|90.0|3.43|38.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||38.61|3.43|0.0493
91694440|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.18|STANDARD_ERROR_OF_MEAN|9.88||0.0005|TWO_SIDED|90.0|17.92|50.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.43|17.92|0.0005
91694441|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.72|STANDARD_ERROR_OF_MEAN|10.73||0.027|TWO_SIDED|90.0|6.07|41.37||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||41.37|6.07|0.0270
91694442|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||51.12|15.80|0.0018
91694443|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||41.96|5.02|0.0363
91694444|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||53.64|19.16|0.0005
91694445|NCT01164579|183283756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||44.50|8.04|0.0177
91694446|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.52|STANDARD_ERROR_OF_MEAN|9.66||0.0197|TWO_SIDED|90.0|6.62|38.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||38.42|6.62|0.0197
91694447|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_ERROR_OF_MEAN|8.16||0.4379|TWO_SIDED|90.0|-7.09|19.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||19.76|-7.09|0.4379
91694448|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||46.34|10.40|0.0093
91694449|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|10.48||0.1669|TWO_SIDED|90.0|-2.75|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||31.73|-2.75|0.1669
91694450|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||46.34|10.40|0.0093
91694451|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.04|STANDARD_ERROR_OF_MEAN|10.64||0.0596|TWO_SIDED|90.0|2.53|37.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||37.55|2.53|0.0596
91694452|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||52.96|16.51|0.0017
91694453|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.52|STANDARD_ERROR_OF_MEAN|11.04||0.0097|TWO_SIDED|90.0|10.36|46.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||46.69|10.36|0.0097
91694454|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.97|STANDARD_ERROR_OF_MEAN|11.11||0.0016|TWO_SIDED|90.0|16.68|53.26||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.26|16.68|0.0016
91694455|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.6|STANDARD_ERROR_OF_MEAN|11.13||0.0102|TWO_SIDED|90.0|10.28|46.91||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||46.91|10.28|0.0102
91694456|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||52.96|16.51|0.0017
91694457|NCT01164579|183283757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|11.07||0.0381|TWO_SIDED|90.0|4.74|41.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.19|4.74|0.0381
91724250|NCT03976375|183342523|OTHER||Difference in Least Squares Means|-8.04||||0.0058|TWO_SIDED|95.0|-13.73|-2.35|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||-2.35|-13.73|0.0058
91724251|NCT03976375|183342524|OTHER||Difference in Least Squares Means|2.89||||0.1681|TWO_SIDED|95.0|-1.23|7.01|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.01|-1.23|0.1681
91724252|NCT03976375|183342525|OTHER||Hazard Ratio (HR)|0.91||||0.6145|TWO_SIDED|95.0|0.63|1.31||stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.31|0.63|0.6145
91724253|NCT03976375|183342526|OTHER||Hazard Ratio (HR)|0.61||||0.0398|TWO_SIDED|95.0|0.38|0.98|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||0.98|0.38|0.0398
91724254|NCT03976375|183342527|OTHER||Hazard Ratio (HR)|1.05||||0.8724|TWO_SIDED|95.0|0.59|1.85|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.85|0.59|0.8724
91724255|NCT03976375|183342528|OTHER||Hazard Ratio (HR)|0.75||||0.1944|TWO_SIDED|95.0|0.49|1.16||Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.49|0.1944
91724256|NCT03976375|183342529|OTHER||Hazard Ratio (HR)|1.0||||0.9837|TWO_SIDED|95.0|0.71|1.41|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.41|0.71|0.9837
91724257|NCT03976375|183342530|OTHER||Hazard Ratio (HR)|0.84||||0.2903|TWO_SIDED|95.0|0.6|1.16|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.60|0.2903
91724258|NCT01590875|183342617|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||no relevant statistical analysis|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||<0.01
91724259|NCT01590875|183342618|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||kappa statistic|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||< 0.01
91724260|NCT05643794|183342634|SUPERIORITY||Difference from Placebo|-0.54||||0.129|TWO_SIDED|95.0|-1.24|0.16|||Longitudinal linear mixed effect model||The difference presented is RLZ 12 weeks minus Placebo.|||0.16|-1.24|0.129
91724261|NCT05643794|183342637|SUPERIORITY||Difference from Placebo|-0.51||||0.358|TWO_SIDED|95.0|-1.6|0.58|||Longitudinal mixed effects model||The difference presented is RLZ 24 weeks minus PBO 24 weeks.|||0.58|-1.60|0.358
91724262|NCT05643794|183342638|SUPERIORITY||Difference from Placebo|-8.4||||0.003|TWO_SIDED|95.0|-13.84|-2.96|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo|||-2.96|-13.84|0.003
91724263|NCT05643794|183342639|SUPERIORITY||Differences from Placebo|0.05||||0.878|TWO_SIDED|95.0|-0.55|0.64|||Longitudinal mixed effects model||The differences presented is RLZ 12 weeks minus Placebo.|||0.64|-0.55|0.878
91724264|NCT05643794|183342640|SUPERIORITY||Difference from Placebo|-0.28||||0.352|TWO_SIDED|95.0|-0.86|0.31|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo.|||0.31|-0.86|0.352
91694458|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|7.67||0.0959|TWO_SIDED|90.0|0.15|25.4||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||25.40|0.15|0.0959
91694459|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|5.4||0.9544|TWO_SIDED|90.0|-8.58|9.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||9.19|-8.58|0.9544
91694460|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
91694461|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|7.66||0.264|TWO_SIDED|90.0|-4.04|21.16||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||21.16|-4.04|0.2640
91694462|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
91694463|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|8.92||0.329|TWO_SIDED|90.0|-5.96|23.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||23.38|-5.96|0.3290
91489898|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.25||||0.0013|TWO_SIDED|95.0|1.68|6.82|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||6.82|1.68|0.0013
91694464|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.84|STANDARD_ERROR_OF_MEAN|10.48||0.0032|TWO_SIDED|90.0|13.59|48.09||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||48.09|13.59|0.0032
91694465|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||33.43|0.79|0.0845
91694466|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|STANDARD_ERROR_OF_MEAN|10.72||0.0037|TWO_SIDED|90.0|13.44|48.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||48.72|13.44|0.0037
91694467|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96|STANDARD_ERROR_OF_MEAN|10.36||0.054|TWO_SIDED|90.0|2.91|37.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||37.02|2.91|0.0540
91724265|NCT02421211|183342660|SUPERIORITY_OR_OTHER||LS means ratio|4.7|||||TWO_SIDED|90.0|3.4|6.5||||||||6.5|3.4|
91724266|NCT02421211|183342661|SUPERIORITY_OR_OTHER||LS means ratio|2.3|||||TWO_SIDED|90.0|2.0|2.8||||||||2.8|2.0|
91724267|NCT02421211|183342662|SUPERIORITY_OR_OTHER||LS means ratio|3.1|||||TWO_SIDED|90.0|2.4|3.8||||||||3.8|2.4|
91724268|NCT02421211|183342663|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.5|2.0||||||||2.0|1.5|
91724269|NCT02421211|183342664|SUPERIORITY_OR_OTHER||LS means ratio|1.6|||||TWO_SIDED|90.0|1.4|1.9||||||||1.9|1.4|
91724270|NCT02421211|183342665|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.6|2.0||||||||2.0|1.6|
91724271|NCT00315822|183342692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94||||0.8|TWO_SIDED|95.0|0.52|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.52|0.80
91724272|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-8.64|STANDARD_ERROR_OF_MEAN|2.232||0.0005|TWO_SIDED|90.0|-12.33|-4.95||Hochberg adjusted p-value|Mixed Models Analysis|||||-4.95|-12.33|0.0005
91724273|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|2.206||0.0963|TWO_SIDED|90.0|-6.99|0.3||Hochberg adjusted p-value|Mixed Models Analysis|||||0.30|-6.99|0.0963
91724274|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-7.07|STANDARD_ERROR_OF_MEAN|2.233||0.0046|TWO_SIDED|90.0|-10.76|-3.37||Hochberg adjusted p-value|Mixed Models Analysis|||||-3.37|-10.76|0.0046
91724275|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.238||0.0963|TWO_SIDED|90.0|-6.63|0.77||Hochberg adjusted p-value|Mixed Models Analysis|||||0.77|-6.63|0.0963
91694468|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.54|STANDARD_ERROR_OF_MEAN|10.24||0.001|TWO_SIDED|90.0|16.7|50.39||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||50.39|16.70|0.0010
91694469|NCT01164579|183283758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.81|STANDARD_ERROR_OF_MEAN|9.66||0.0401|TWO_SIDED|90.0|3.92|35.71||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||35.71|3.92|0.0401
91694470|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.91|STANDARD_ERROR_OF_MEAN|10.99||0.0005|TWO_SIDED|90.0|19.83|55.99||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||55.99|19.83|0.0005
91694471|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.12|STANDARD_ERROR_OF_MEAN|11.09||0.0028|TWO_SIDED|90.0|14.87|51.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||51.38|14.87|0.0028
91694472|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.83|STANDARD_ERROR_OF_MEAN|10.1||0.0105|TWO_SIDED|90.0|9.21|42.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.45|9.21|0.0105
91694473|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|STANDARD_ERROR_OF_MEAN|11.13||0.37|TWO_SIDED|90.0|-8.33|28.3||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||28.30|-8.33|0.3700
91694474|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.82|STANDARD_ERROR_OF_MEAN|9.54|<|0.0001|TWO_SIDED|90.0|24.11|55.53||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||55.53|24.11|<0.0001
91694475|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.09|STANDARD_ERROR_OF_MEAN|11.24||0.1076|TWO_SIDED|90.0|-0.4|36.59||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||36.59|-0.40|0.1076
91724276|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-10.07|STANDARD_ERROR_OF_MEAN|2.152|<|0.0001|TWO_SIDED|90.0|-13.63|-6.51||Hochberg adjusted p-value|Mixed Models Analysis|||||-6.51|-13.63|<0.0001
91724277|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|2.255||0.0158|TWO_SIDED|90.0|-9.79|-2.33||Hochberg adjusted p-value|Mixed Models Analysis|||||-2.33|-9.79|0.0158
91724278|NCT02969018|183342709|OTHER||Least Squares Mean Difference|-4.66|STANDARD_ERROR_OF_MEAN|2.163||0.0488|TWO_SIDED|90.0|-8.24|-1.09||Hochberg adjusted p-value|Mixed Models Analysis|||||-1.09|-8.24|0.0488
91724279|NCT02969018|183342710|OTHER||Odds Ratio (OR)|10.0|||||TWO_SIDED|90.0|2.95|33.87|||||||Logistic regression|33.87|2.95|
91724280|NCT02969018|183342710|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|90.0|0.61|7.36|||||||Logistic regression|7.36|0.61|
91724281|NCT02969018|183342710|OTHER||Odds Ratio (OR)|9.09|||||TWO_SIDED|90.0|2.71|30.48|||||||Logistic regression|30.48|2.71|
91724282|NCT02969018|183342710|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
91724283|NCT02969018|183342710|OTHER||Odds Ratio (OR)|41.67|||||TWO_SIDED|90.0|10.8|160.68|||||||Logistic regression|160.68|10.80|
91724284|NCT02969018|183342710|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
91724285|NCT02969018|183342710|OTHER||Odds Ratio (OR)|3.86|||||TWO_SIDED|90.0|1.17|12.74|||||||Logistic regression|12.74|1.17|
91724286|NCT02969018|183342711|OTHER||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|90.0|-11.43|-6.57|||Mixed Models Analysis|||||-6.57|-11.43|<0.0001
91694476|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|STANDARD_ERROR_OF_MEAN|10.21||0.0008|TWO_SIDED|90.0|17.13|50.75||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.75|17.13|0.0008
91694477|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.42|STANDARD_ERROR_OF_MEAN|10.74||0.0139|TWO_SIDED|90.0|8.74|44.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||44.10|8.74|0.0139
91694478|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.64|19.16|0.0005
91694479|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5|||Normal approximation to the binomial|||Month 9||44.50|8.04|0.0177
91694480|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.12|15.80|0.0018
91694481|NCT01164579|183283759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.96|5.02|0.0363
91694482|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.88|STANDARD_ERROR_OF_MEAN|7.42||0.016|TWO_SIDED|90.0|5.66|30.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||30.10|5.66|0.0160
91694483|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|5.43||0.2798|TWO_SIDED|90.0|-3.06|14.8||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||14.80|-3.06|0.2798
91694484|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
91694485|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78|STANDARD_ERROR_OF_MEAN|7.3||0.4287|TWO_SIDED|90.0|-6.23|17.79||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||17.79|-6.23|0.4287
91694486|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
91694487|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.04|STANDARD_ERROR_OF_MEAN|9.51||0.0732|TWO_SIDED|90.0|1.39|32.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||32.69|1.39|0.0732
91694488|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.25|STANDARD_ERROR_OF_MEAN|10.61||0.036|TWO_SIDED|90.0|4.79|39.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||39.72|4.79|0.0360
91694489|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.85|STANDARD_ERROR_OF_MEAN|9.85||0.3688|TWO_SIDED|90.0|-7.35|25.07||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||25.07|-7.35|0.3688
91694490|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.19|STANDARD_ERROR_OF_MEAN|10.67||0.0182|TWO_SIDED|90.0|7.63|42.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||42.76|7.63|0.0182
91694491|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
91694492|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.78|STANDARD_ERROR_OF_MEAN|10.49||0.0012|TWO_SIDED|90.0|16.51|51.05||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.05|16.51|0.0012
91694493|NCT01164579|183283760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.33|STANDARD_ERROR_OF_MEAN|9.78||0.1426|TWO_SIDED|90.0|-1.74|30.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||30.42|-1.74|0.1426
91694494|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|4.03||0.1449|TWO_SIDED|90.0|-0.75|12.52||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||12.52|-0.75|0.1449
91694495|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
91694496|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|7.06||0.0342|TWO_SIDED|90.0|3.32|26.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||26.55|3.32|0.0342
91694497|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|4.65||0.54|TWO_SIDED|90.0|-4.8|10.51||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||10.51|-4.80|0.5400
91694498|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.01|STANDARD_ERROR_OF_MEAN|9.19||0.2759|TWO_SIDED|90.0|-5.1|25.13||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||25.13|-5.10|0.2759
91694499|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|6.25||0.0859|TWO_SIDED|90.0|-21.02|-0.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||-0.45|-21.02|0.0859
91694500|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|9.62||0.0985|TWO_SIDED|90.0|0.06|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||31.73|0.06|0.0985
91694501|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|8.05||0.9628|TWO_SIDED|90.0|-12.86|13.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||13.61|-12.86|0.9628
91694502|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|STANDARD_ERROR_OF_MEAN|10.19||0.0612|TWO_SIDED|90.0|2.31|35.84||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||35.84|2.31|0.0612
91694503|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|8.36||0.7807|TWO_SIDED|90.0|-16.08|11.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||11.43|-16.08|0.7807
91694504|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||34.95|2.72|0.0544
91489899|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.71|||<|0.0001|TWO_SIDED|95.0|5.2|10.21|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||10.21|5.20|<0.0001
91489900|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.03|||<|0.0001|TWO_SIDED|95.0|4.51|9.55|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||9.55|4.51|<0.0001
91489901|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.0325|TWO_SIDED|95.0|0.23|5.32|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).|||5.32|0.23|0.0325
91489902|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.092|TWO_SIDED|95.0|-4.67|0.35|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.|||0.35|-4.67|0.0920
91489903|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.2185|TWO_SIDED|95.0|-4.04|0.93|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.|||0.93|-4.04|0.2185
91489904|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.87|||<|0.0001|TWO_SIDED|95.0|7.36|12.37|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).|||12.37|7.36|<0.0001
91489905|NCT02195583|182852325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.26|||<|0.0001|TWO_SIDED|95.0|6.77|11.75|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).|||11.75|6.77|<0.0001
91489906|NCT00094172|182852353|SUPERIORITY_OR_OTHER|||||||0.929|||||||Log Rank|||This is the primary analysis of the primary endpoint||||0.929
91489907|NCT00094172|182852353|SUPERIORITY_OR_OTHER|||||||0.823|||||||Fisher Exact|||This is the secondary analysis of the primary endpoint||||0.823
91489908|NCT00094172|182852354|SUPERIORITY_OR_OTHER|||||||0.208|||||||Log Rank|||||||.208
91489909|NCT00094172|182852355|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Log Rank|||||||0.526
91489910|NCT01519271|182852374|SUPERIORITY||Cohen's D|0.35|||||TWO_SIDED|||||||||||||
91489911|NCT01803204|182852432|SUPERIORITY_OR_OTHER||GEE|1.0||||1|TWO_SIDED|99.0|||||GEE|||||||1.00
91489912|NCT01803204|182852433|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||Mist Effects Model|||||||<0.01
91489913|NCT01803204|182852434|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|99.0|||||Mist Effect Model|||||||0.81
91694505|NCT01164579|183283761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|STANDARD_ERROR_OF_MEAN|8.66||0.4937|TWO_SIDED|90.0|-8.32|20.18||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||20.18|-8.32|0.4937
91724287|NCT02969018|183342711|OTHER||Least Squares Mean Difference|-7.99|STANDARD_ERROR_OF_MEAN|1.502|<|0.0001|TWO_SIDED|90.0|-10.48|-5.51|||Mixed Models Analysis|||||-5.51|-10.48|<0.0001
91489914|NCT01397890|182852438|SUPERIORITY_OR_OTHER||Ratio|1.044||||0.0004|TWO_SIDED|95.0|1.019|1.069|||ANCOVA|multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate||||1.069|1.019|0.0004
91489915|NCT01397890|182852439|SUPERIORITY_OR_OTHER||Ratio|1.079|||<|0.0001|TWO_SIDED|95.0|1.057|1.102|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.102|1.057|<0.0001
91489916|NCT01397890|182852440|SUPERIORITY_OR_OTHER||Ratio|1.086|||<|0.0001|TWO_SIDED|95.0|1.062|1.111|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.111|1.062|<0.0001
91489917|NCT01397890|182852441|SUPERIORITY_OR_OTHER||Ratio|1.018||||0.057|TWO_SIDED|95.0|0.999|1.037|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.037|0.999|0.0570
91489918|NCT01397890|182852442|SUPERIORITY_OR_OTHER||Ratio|1.05|||<|0.0001|TWO_SIDED|95.0|1.033|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.067|1.033|<0.0001
91489919|NCT01397890|182852443|SUPERIORITY_OR_OTHER||Ratio|1.054|||<|0.0001|TWO_SIDED|95.0|1.036|1.073|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.073|1.036|<0.0001
91489920|NCT01397890|182852444|SUPERIORITY_OR_OTHER||Ratio|1.02||||0.1956|TWO_SIDED|95.0|0.99|1.05|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.050|0.990|0.1956
91489921|NCT01397890|182852445|SUPERIORITY_OR_OTHER||Ratio|1.062|||<|0.0001|TWO_SIDED|95.0|1.035|1.091|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.091|1.035|<0.0001
91489922|NCT01397890|182852446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.303||||0.0001|TWO_SIDED|95.0|9.904|30.702|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.702|9.904|0.0001
91489923|NCT01397890|182852447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.587|||<|0.0001|TWO_SIDED|95.0|7.407|19.766|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||19.766|7.407|<0.0001
91724288|NCT00827242|183342723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.66||0.004||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.004
91489924|NCT01397890|182852448|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.469|||<|0.0001|TWO_SIDED|95.0|10.147|24.791|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||24.791|10.147|<0.0001
91489925|NCT01397890|182852449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.428||||0.0001|TWO_SIDED|95.0|13.463|39.393|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||39.393|13.463|0.0001
91489926|NCT01397890|182852450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.192||||0.0006|TWO_SIDED|95.0|7.491|26.894|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.894|7.491|0.0006
91489927|NCT01397890|182852451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.472|||<|0.0001|TWO_SIDED|95.0|10.347|26.596|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.596|10.347|<0.0001
91489928|NCT01397890|182852452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.668|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.437|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.437|-0.900|<0.0001
91489929|NCT01397890|182852453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.375|||<|0.0001|TWO_SIDED|95.0|-0.552|-0.198|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.198|-0.552|<0.0001
91489930|NCT01397890|182852454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||<|0.0001|TWO_SIDED|95.0|-0.741|-0.361|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.361|-0.741|<0.0001
91489931|NCT01397890|182852455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.236||||0.0028|TWO_SIDED|95.0|-0.391|-0.082|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.082|-0.391|0.0028
91489932|NCT01397890|182852456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.0372|TWO_SIDED|95.0|-0.24|-0.007|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.007|-0.240|0.0372
91489933|NCT01397890|182852457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.0001|TWO_SIDED|95.0|-0.35|-0.113|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.113|-0.350|0.0001
91724289|NCT00827242|183342724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.26||0.029||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.029
91489934|NCT01397890|182852458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|||<|0.0001|TWO_SIDED|95.0|-0.364|-0.159|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.159|-0.364|<0.0001
91489935|NCT01397890|182852459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.143||||0.0067|TWO_SIDED|95.0|-0.246|-0.04|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.040|-0.246|0.0067
91489936|NCT01397890|182852460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.0171|TWO_SIDED|95.0|-0.222|-0.022|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.022|-0.222|0.0171
91724290|NCT00827242|183342725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.057||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.057
91724291|NCT00827242|183342726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS storage subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.002
91724292|NCT00827242|183342727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43||0.02||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS voiding subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.020
91724293|NCT00827242|183342728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.233||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS nocturia question. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.233
91724294|NCT00827242|183342729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.013||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS QoL Index. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.013
91724295|NCT00827242|183342730|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.021
91724296|NCT00827242|183342731|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.009
91724297|NCT00827242|183342732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.146||95.0||||The p-value associates with LS Mean difference of changes from baseline to 1 week between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.146
91724298|NCT00827242|183342733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.003
91489937|NCT01397890|182852461|SUPERIORITY_OR_OTHER||Rate ratio|0.593||||0.0032|TWO_SIDED|95.0|0.419|0.839|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable morning PEF as a covariate||||0.839|0.419|0.0032
91724299|NCT00827242|183342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IIEF-EF domain score. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||<0.001
91724300|NCT00827242|183342735|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for Qmax. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.300
91724301|NCT00827242|183342738|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for PVR volume. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.500
91724302|NCT01479530|183342761|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0228|TWO_SIDED|95.0|-0.92|-0.07|||ANCOVA|||||-0.07|-0.92|0.0228
91724303|NCT01479530|183342762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||ANCOVA|||||-0.22|-0.61|<0.0001
91724304|NCT01479530|183342763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.37||0.0075|TWO_SIDED|95.0|-1.75|-0.27|||ANCOVA|||||-0.27|-1.75|0.0075
91724305|NCT01479530|183342764|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.74||0.0317|TWO_SIDED|95.0|-3.05|-0.14|||ANCOVA|||||-0.14|-3.05|0.0317
91489938|NCT01397890|182852461|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.614||||0.0167|TWO_SIDED|95.0|0.412|0.916|||Regression, Cox|Time to the first COPD exacerbation||||0.916|0.412|0.0167
91724306|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.82|4.38|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual. Sample sizing calculated based on results from previous methodology studies performed using the same cold pain test; primary criteria was ability to detect a significant gabapentin effect over placebo.||4.38|-3.82|
91724307|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.53|4.68|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.68|-3.53|
91489939|NCT01397890|182852461|SUPERIORITY_OR_OTHER|||||||0.0196|||||||Log Rank|||||||0.0196
91489940|NCT02100514|182852492|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.9|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-54.0|-45.8|||MMRM|||Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-45.8|-54.0|<0.001
91724308|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.99|4.22|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.99|
91724309|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-1.15|5.44|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||5.44|-1.15|
91724310|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-14.48|-7.89|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.89|-14.48|
91724311|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|90.0|2.2|8.78|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||8.78|2.20|
91724312|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-5.53|4.08|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.08|-5.53|
91724313|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-18.74|-9.13|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-9.13|-18.74|
91724314|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.88|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-2.01|7.78|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.78|-2.01|
91724315|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.66|||TWO_SIDED|90.0|-5.32|6.96|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||6.96|-5.32|
91724316|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.12|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-19.14|-7.09|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.09|-19.14|
91724317|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-4.45|7.6|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.60|-4.45|
91489941|NCT02100514|182852493|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.2|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-36.1|-30.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-30.2|-36.1|<0.001
91489942|NCT02100514|182852493|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-29.6|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-32.8|-26.3||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-26.3|-32.8|
91724318|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-7.39|2.32||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||2.32|-7.39|
91724319|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-14.44|-4.73|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-4.73|-14.44|
91724320|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-4.85|4.85|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.85|-4.85|
91724321|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.23|4.22|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.23|
91724322|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.47|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-11.19|-3.75|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-3.75|-11.19|
91724323|NCT01119222|183342765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.99|3.45|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||3.45|-3.99|
91724324|NCT01119222|183342766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-4.24|3.04|||Mixed Models Analysis|||||3.04|-4.24|
91724325|NCT01119222|183342766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.43|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-13.07|-5.79|||Mixed Models Analysis|||||-5.79|-13.07|
91724326|NCT01119222|183342766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-2.8|4.48|||Mixed Models Analysis|||||4.48|-2.80|
91759987|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.27|||||TWO_SIDED|95.0|-19.95|-0.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-19.95|
91489943|NCT02100514|182852493|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-23.8|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|95.0|-27.0|-20.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-20.5|-27.0|
91489944|NCT02100514|182852494|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.7|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-49.7|-41.7|||MMRM|||Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.7|-49.7|<0.001
91489945|NCT02100514|182852494|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.9|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.3|-36.5||||||Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.5|-45.3|
91489946|NCT02100514|182852494|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.5|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|95.0|-36.7|-28.2||||||Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.2|-36.7|
91694506|NCT00507455|183283795|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-6.15|||||TWO_SIDED|95.0|-14.67|2.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.37|-14.67|
91694507|NCT00507455|183283795|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-5.0|||||TWO_SIDED|95.0|-13.85|3.84|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.84|-13.85|
91694508|NCT00507455|183283797|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|1.67|||||TWO_SIDED|95.0|0.5|2.85|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.85|0.50|
91694509|NCT00507455|183283797|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|2.18|||||TWO_SIDED|95.0|0.98|3.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.37|0.98|
91694510|NCT06110494|183283840|OTHER|Pairwise comparisons were done using Mann-Whitney U test of log10 transformed CFU reduction data to compare the antimicrobial effectiveness.||||||0.05||||||Pairwise comparisons were done using Mann-Whitney U test of log 10 transformed data to compare the antimicrobial effectiveness of Fer/H2O2 in comparison with the negative (saline) and positive (NaOCl) controls with P values set at \< 0.05|Wilcoxon (Mann-Whitney)|||The sample size estimate was calculated in Pass Software 2021, using a test that compares the ratio of two means from independent samples using data that has been log-normalized. An alpha of 0.05 and power of 80% was assumed, with means and standard deviations pulled from previous studies that employed similar methodology. This produced a required sample size of 16 for each group. Pairwise comparisons were done using Mann-Whitney U test to compare the antimicrobial effectiveness.||||0.05
91694511|NCT01605552|183283877|SUPERIORITY|||||||0.21|||||||ANCOVA||||Cohen's d = 0.61|||.21
91694512|NCT01605552|183283878|SUPERIORITY|||||||0.019|||||||ANCOVA||||Cohen's d = 1.33|||.019
91694513|NCT01605552|183283879|SUPERIORITY|||||||0.09|||||||ANCOVA||||Cohen's d = 0.78|||.09
91694514|NCT01605552|183283880|SUPERIORITY|||||||0.43|||||||ANCOVA||||Cohen's d = 0.43|||.43
91694515|NCT01737710|183283881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.082|TWO_SIDED|95.0|0.92|3.55||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||3.55|0.92|0.082
91724327|NCT01944774|183342784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.291||||0.133|TWO_SIDED|95.0|0.058|1.457||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.457|0.058|0.133
91694516|NCT01737710|183283882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.801|TWO_SIDED|95.0|0.26|2.56||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups|Fisher Exact|||||2.56|0.26|0.801
91694517|NCT01737710|183283883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.177|TWO_SIDED|95.0|0.75|5.71||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||5.71|0.75|0.177
91694518|NCT01737710|183283884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.092|TWO_SIDED|95.0|0.96|1.61||Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.|ANCOVA|||||1.61|0.96|0.092
91694519|NCT01737710|183283885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.103|TWO_SIDED|95.0|0.32|1.11||Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.|ANCOVA|||||1.11|0.32|0.103
91694520|NCT01737710|183283886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.895|TWO_SIDED|95.0|0.6|1.8||Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.|ANCOVA|||||1.80|0.60|0.895
91694521|NCT01737710|183283887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|||>|0.999|TWO_SIDED|95.0|0.54|1.97||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.97|0.54|>0.999
91694522|NCT01737710|183283888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.253|TWO_SIDED|95.0|0.09|1.63||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||1.63|0.09|0.253
91694523|NCT01737710|183283889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.218|TWO_SIDED|95.0|0.06|1.58||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||1.58|0.06|0.218
91694524|NCT01737710|183283890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.14|TWO_SIDED|95.0|0.84|2.94||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||2.94|0.84|0.140
91694525|NCT01737710|183283891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.791|TWO_SIDED|95.0|0.24|2.65||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.65|0.24|0.791
91694526|NCT01737710|183283892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.833|TWO_SIDED|95.0|0.47|2.92||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||2.92|0.47|0.833
91694527|NCT01737710|183283893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.378|TWO_SIDED|95.0|0.4|1.38||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.38|0.40|0.378
91694528|NCT01737710|183283894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.783|TWO_SIDED|95.0|0.21|2.62||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.62|0.21|0.783
91694529|NCT01737710|183283895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.143|TWO_SIDED|95.0|0.13|1.39|||Fisher Exact|Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.||||1.39|0.13|0.143
91694530|NCT03935425|183283909|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91694531|NCT00885664|183283911|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
91694532|NCT00885664|183283912|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91694533|NCT00885664|183283913|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91694534|NCT00885664|183283914|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
91694535|NCT00885664|183283915|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
91694536|NCT00885664|183283916|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91694537|NCT00885664|183283917|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91694538|NCT00885664|183283918|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91694539|NCT00885664|183283919|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91528001|NCT03662997|182931041|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer arm; Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.010
91694540|NCT00885664|183283920|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91694541|NCT00885664|183283921|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91694542|NCT01342770|183283922|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Signed Rank|||||||0.06
91694543|NCT00921557|183283937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 24||||<0.001
91694544|NCT00921557|183283937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 48||||<0.001
91694545|NCT00921557|183283938|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||||||Not adjusted for multiple comparisons|Fisher Exact|||Comparison of percentage of participants experiencing primary safety outcome||||>0.99
91694546|NCT00911612|183283957|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Not adjusted since only one comparison was made.|ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for baseline geometric center at 24 hours , BMI, and 7 alpha CHO.||||0.22
91694547|NCT00911612|183283958|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for BMI and 7 alpha HCO.||||0.02
91694548|NCT02560922|183283999|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.128|TWO_SIDED|95.0|-1.45|0.18|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.18|-1.45|0.128
91694549|NCT02560922|183283999|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.068|TWO_SIDED|95.0|-1.73|0.06|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.06|-1.73|0.068
91694550|NCT02560922|183284000|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.129|TWO_SIDED|95.0|-6.01|0.77|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.77|-6.01|0.129
91694551|NCT02560922|183284000|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.084|TWO_SIDED|95.0|-7.07|0.44|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.44|-7.07|0.084
91694552|NCT02560922|183284001|SUPERIORITY||Mean Difference (Final Values)|-1.61||||0.209|TWO_SIDED|95.0|-4.14|0.91|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.91|-4.14|0.209
91694553|NCT02560922|183284001|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.128|TWO_SIDED|95.0|-5.03|0.63|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.63|-5.03|0.128
91694554|NCT02560922|183284002|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.222|TWO_SIDED|95.0|-2.18|0.51|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.51|-2.18|0.222
91694555|NCT02560922|183284002|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.128|TWO_SIDED|95.0|-2.6|0.33|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.33|-2.60|0.128
91694556|NCT02560922|183284003|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.111|TWO_SIDED|95.0|-0.4|3.82|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||3.82|-0.40|0.111
91694557|NCT02560922|183284003|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.502|TWO_SIDED|95.0|-1.42|2.88|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||2.88|-1.42|0.502
91694558|NCT02560922|183284004|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.433|TWO_SIDED|95.0|-1.15|2.66|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||2.66|-1.15|0.433
91694559|NCT02560922|183284004|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.12|TWO_SIDED|95.0|-0.45|3.86|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||3.86|-0.45|0.120
91694560|NCT02560922|183284005|SUPERIORITY||Mean Difference (Final Values)|15.31||||0.001|TWO_SIDED|95.0|9.09|21.53|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||21.53|9.09|0.001
91694561|NCT02560922|183284005|SUPERIORITY||Mean Difference (Final Values)|11.67|||<|0.001|TWO_SIDED|95.0|5.08|18.27|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||18.27|5.08|<0.001
91694562|NCT02560922|183284006|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.356|TWO_SIDED|95.0|-1.57|0.57|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.57|-1.57|0.356
91694563|NCT02560922|183284006|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.087|TWO_SIDED|95.0|-2.19|0.15|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.15|-2.19|0.087
91694564|NCT02560922|183284007|SUPERIORITY||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.41|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||1.41|0.61|<0.001
91694565|NCT02560922|183284007|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.002|TWO_SIDED|95.0|0.24|1.09|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||1.09|0.24|0.002
91694566|NCT02560922|183284008|SUPERIORITY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.6|-0.95|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 3 months||-0.95|-1.60|<0.001
91694567|NCT02560922|183284008|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 9 months||-0.51|-1.24|<0.001
91694568|NCT01422889|183284053|SUPERIORITY_OR_OTHER||percentage|2.2|||||TWO_SIDED|||||A p-value was not calculated for the ION Registry 12 month cardiac events. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months||||
91694569|NCT01422889|183284054|SUPERIORITY_OR_OTHER||percentage|2.6|||||ONE_SIDED|||||A p-value was not calculated for the ION Registry 2 year cardiac events. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.||||
91694570|NCT00086138|183284058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.52|1.97|||Chi-squared|||The statistical analyses compared data collected from the CGIC of participants who received sertraline who had a score equal to or better than the CGIC of participants who received the placebo intervention.||1.97|0.52|0.98
91694571|NCT00086138|183284059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.11|TWO_SIDED|95.0|0.84|5.04|||Chi-squared|||||5.04|0.84|0.11
91694572|NCT01014169|183284092|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||||1.34|0.95|
91694573|NCT01014169|183284093|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.99|1.25||||||||1.25|0.99|
91694574|NCT01014169|183284094|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||||95.0|1.0|1.25||||||||1.25|1.00|
91694575|NCT04873934|183284097|SUPERIORITY||LS mean difference|-46.9|||<|0.001|TWO_SIDED|97.5|-55.4|-38.5|||Mixed Models Analysis|||||-38.5|-55.4|< 0.001
91694576|NCT04873934|183284098|SUPERIORITY||Odds Ratio (OR)|5.42|||<|0.001|TWO_SIDED|97.5|3.29|8.91|||Regression, Logistic|||||8.91|3.29|< 0.001
91694577|NCT04873934|183284099|SUPERIORITY||LS mean difference|-42.0|||<|0.001|TWO_SIDED|95.0|-47.3|-36.7|||Mixed Models Analysis|||Day 90||-36.7|-47.3|< 0.001
91694578|NCT04873934|183284099|SUPERIORITY||LS mean difference|-30.8|||<|0.001|TWO_SIDED|95.0|-37.4|-24.3|||Mixed Models Analysis|||Day 270||-24.3|-37.4|< 0.001
91694579|NCT04873934|183284099|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.5|-31.0|||Mixed Models Analysis|||Day 330||-31.0|-44.5|< 0.001
91694580|NCT04873934|183284100|SUPERIORITY||LS mean difference|-46.7|||<|0.001|TWO_SIDED|95.0|-52.7|-40.8|||ANCOVA|||||-40.8|-52.7|< 0.001
91694581|NCT04873934|183284101|SUPERIORITY||LS mean difference|-37.3|||<|0.001|TWO_SIDED|95.0|-42.4|-32.2|||ANCOVA|||||-32.2|-42.4|< 0.001
91694582|NCT04873934|183284102|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|6.33|22.25|||Regression, Logistic|||||22.25|6.33|< 0.001
91694583|NCT04873934|183284103|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|1.92|9.99|||Regression, Logistic|||Achieving LDL-C \< 100 mg/dL||9.99|1.92|< 0.001
91694584|NCT04873934|183284103|SUPERIORITY||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|4.97|13.65|||Regression, Logistic|||Achieving LDL-C \< 55 mg/dL||13.65|4.97|< 0.001
91694585|NCT04873934|183284104|SUPERIORITY||LS mean difference|-37.5|||<|0.001|TWO_SIDED|95.0|-44.8|-30.3|||Mixed Models Analysis|||Apolipoprotein B||-30.3|-44.8|< 0.001
91694586|NCT04873934|183284104|SUPERIORITY||LS mean difference|-6.4||||0.188|TWO_SIDED|95.0|-16.0|3.1|||Mixed Models Analysis|||VLDL Cholesterol||3.1|-16.0|0.188
91694587|NCT04873934|183284104|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.0|-31.4|||Mixed Models Analysis|||Non-HDL Cholesterol||-31.4|-44.0|< 0.001
91694588|NCT04873934|183284104|SUPERIORITY||LS mean difference|-25.5|||<|0.001|TWO_SIDED|95.0|-30.2|-20.7|||Mixed Models Analysis|||Total Cholesterol||-20.7|-30.2|< 0.001
91694589|NCT04873934|183284104|SUPERIORITY||LS mean difference|-16.4||||0.145|TWO_SIDED|95.0|-38.4|5.7|||Mixed Models Analysis|||Lipoprotein(a)||5.7|-38.4|0.145
91694590|NCT04873934|183284104|SUPERIORITY||LS mean difference|3.5||||0.141|TWO_SIDED|95.0|-1.2|8.1|||Mixed Models Analysis|||HDL Cholesterol||8.1|-1.2|0.141
91694591|NCT04873934|183284104|SUPERIORITY||LS mean difference|-5.0||||0.339|TWO_SIDED|95.0|-15.2|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-15.2|0.339
91694592|NCT04873934|183284105|SUPERIORITY||LS mean difference|-28.4|||<|0.001|TWO_SIDED|95.0|-33.0|-23.9|||Mixed Models Analysis|||Apolipoprotein B||-23.9|-33.0|< 0.001
91694593|NCT04873934|183284105|SUPERIORITY||LS mean difference|-2.1||||0.078|TWO_SIDED|95.0|-4.5|0.2|||Mixed Models Analysis|||VLDL Cholesterol||0.2|-4.5|0.078
91694594|NCT04873934|183284105|SUPERIORITY||LS mean difference|-40.1|||<|0.001|TWO_SIDED|95.0|-47.5|-32.8|||Mixed Models Analysis|||Non-HDL Cholesterol||-32.8|-47.5|< 0.001
91694595|NCT04873934|183284105|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-45.3|-30.2|||Mixed Models Analysis|||Total Cholesterol||-30.2|-45.3|< 0.001
91694596|NCT04873934|183284105|SUPERIORITY||LS mean difference|1.9||||0.065|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||HDL Cholesterol||3.8|-0.1|0.065
91694597|NCT04873934|183284105|SUPERIORITY||LS mean difference|-8.7||||0.222|TWO_SIDED|95.0|-22.8|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-22.8|0.222
91694598|NCT04873934|183284106|SUPERIORITY||LS mean difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Lipoprotein(a)||-4.2|-23.8|0.005
91694599|NCT04873934|183284107|SUPERIORITY||Odds Ratio (OR)|0.43||||0.031|TWO_SIDED|95.0|0.2|0.93|||proportional odds model|||||0.93|0.20|0.031
91694600|NCT04873934|183284108|SUPERIORITY||LS mean difference|-0.039||||0.043|TWO_SIDED|95.0|-0.077|-0.001|||ANCOVA|||||-0.001|-0.077|0.043
91694601|NCT04873934|183284109|SUPERIORITY||Odds Ratio (OR)|0.76||||0.346|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|||||1.35|0.43|0.346
91694602|NCT00953654|183284120|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|The degrees of freedom were adjusted when the sphericity assumption was violated based on Mauchly's test.||Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.||||<0.05
91694603|NCT02915705|183284131|SUPERIORITY||LS Mean Difference|1.14|||<|0.0001|TWO_SIDED|95.0|0.83|1.45|||ANCOVA|||Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.||1.45|0.83|< 0.0001
91489947|NCT02100514|182852495|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.9|-41.1|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.1|-48.9|<0.001
91489948|NCT02100514|182852495|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.5|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-44.8|-36.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.1|-44.8|
91489949|NCT02100514|182852495|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.7|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|95.0|-37.0|-28.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.4|-37.0|
91489950|NCT02100514|182852496|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-51.6|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-56.7|-46.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-46.6|-56.7|<0.001
91528002|NCT03662997|182931041|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.25||||||Five-layer vs Hydropolymer arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.25
91489951|NCT02100514|182852496|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.4|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-52.2|-40.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-40.6|-52.2|
91528003|NCT03662997|182931042|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular; End of Weeks 1 and 3.|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
91694604|NCT02915705|183284132|SUPERIORITY||Odds Ratio (OR)|39.1|||<|0.0001|TWO_SIDED|95.0|7.2|211.7||Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|Regression, Logistic|||||211.7|7.2|< 0.0001
91694605|NCT02915705|183284133|SUPERIORITY||Odds Ratio (OR)|34.1||||0.0002|TWO_SIDED|95.0|5.6|206.3||Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.|generalized linear mixed model|||||206.3|5.6|0.0002
91694606|NCT02915705|183284134|SUPERIORITY||difference in LS means|1.02|||<|0.0001|TWO_SIDED|95.0|0.72|1.33|||GEE model|||Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.||1.33|0.72|< 0.0001
91694607|NCT02915705|183284135|SUPERIORITY||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.94||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|ANCOVA|||||-0.94|-1.74|< 0.0001
91694608|NCT02915705|183284136|SUPERIORITY||difference in LS means|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.83||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.|GEE model|||||-0.83|-1.59|< 0.0001
91694609|NCT02915705|183284137|SUPERIORITY||LS Mean Difference|0.4||||0.0162|TWO_SIDED|95.0|0.07|0.72||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||0.72|0.07|0.0162
91694610|NCT02915705|183284138|SUPERIORITY||difference in LS means|0.97|||<|0.0001|TWO_SIDED|95.0|0.57|1.37||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||1.37|0.57|< 0.0001
91694611|NCT02915705|183284139|SUPERIORITY||LS Mean Difference|0.12||||0.0408|TWO_SIDED|95.0|0.01|0.24|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.24|0.01|0.0408
91694612|NCT02915705|183284140|SUPERIORITY||difference in LS means|0.14||||0.049|TWO_SIDED|95.0|0.0|0.29|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.29|0.00|0.0490
91489952|NCT02100514|182852496|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-37.4|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|95.0|-43.3|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.4|-43.3|
91528004|NCT03662997|182931042|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer; End of Weeks 1 \& 3|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups|||0.010
91694613|NCT02915705|183284141|SUPERIORITY||difference in LS means|1.02||||0.0386|TWO_SIDED|95.0|0.06|1.99|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.99|0.06|0.0386
91694614|NCT02915705|183284142|SUPERIORITY||difference in LS means|1.12||||0.0047|TWO_SIDED|95.0|0.37|1.88|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.88|0.37|0.0047
91694615|NCT02915705|183284143|SUPERIORITY||difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.81|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||1.27|0.81|< 0.0001
91694616|NCT02915705|183284143|SUPERIORITY||difference|1.03|||<|0.0001|TWO_SIDED|95.0|0.79|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||1.27|0.79|< 0.0001
91694617|NCT02915705|183284143|SUPERIORITY||difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.97|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||0.97|0.58|< 0.0001
91694618|NCT02915705|183284143|SUPERIORITY||difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.44|0.81|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||0.81|0.44|< 0.0001
91694619|NCT02915705|183284143|SUPERIORITY||difference|0.51|||<|0.0001|TWO_SIDED|95.0|0.3|0.72|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||0.72|0.30|< 0.0001
91694620|NCT02915705|183284143|SUPERIORITY||difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.51|0.89|||GEE model|||Week 32||0.89|0.51|< 0.0001
91694621|NCT02915705|183284143|SUPERIORITY||difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.91|||GEE model||Difference (burosumab - Oral Phosphate/Active Vitamin D)|Week 40||0.91|0.51|< 0.0001
91694622|NCT02915705|183284143|SUPERIORITY||difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.39|0.82|||GEE model|||Week 52||0.82|0.39|< 0.0001
91694623|NCT02915705|183284143|SUPERIORITY||difference|0.69|||<|0.0001|TWO_SIDED|95.0|0.49|0.9|||GEE model|||Week 64||0.90|0.49|< 0.0001
91694624|NCT02915705|183284145|SUPERIORITY||difference in LS means|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.91|||ANCOVA||Difference (KRN23 - Oral Phosphate/Active Vitamin D)|||0.91|0.58|< 0.0001
91694625|NCT02915705|183284148|SUPERIORITY||difference|48.27|||<|0.0001|TWO_SIDED|95.0|36.53|60.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||60.02|36.53|< 0.0001
91694626|NCT02915705|183284148|SUPERIORITY||difference|21.09|||<|0.0001|TWO_SIDED|95.0|12.01|30.16|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||30.16|12.01|< 0.0001
91694627|NCT02915705|183284148|SUPERIORITY||difference|15.75||||0.001|TWO_SIDED|95.0|6.35|25.15|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||25.15|6.35|0.0010
91694628|NCT02915705|183284148|SUPERIORITY||difference|12.97||||0.0078|TWO_SIDED|95.0|3.41|22.53|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||22.53|3.41|0.0078
91694629|NCT02915705|183284148|SUPERIORITY||difference|10.89||||0.0101|TWO_SIDED|95.0|2.59|19.19|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||19.19|2.59|0.0101
91694630|NCT02915705|183284148|SUPERIORITY||difference|6.23||||0.1165|TWO_SIDED|95.0|-1.55|14.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 32||14.02|-1.55|0.1165
91694631|NCT02915705|183284148|SUPERIORITY||difference|11.21||||0.0317|TWO_SIDED|95.0|0.98|21.44|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||21.44|0.98|0.0317
91694632|NCT02915705|183284148|SUPERIORITY||difference|5.01||||0.3044|TWO_SIDED|95.0|-4.55|14.56|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||14.56|-4.55|0.3044
91694633|NCT02915705|183284148|SUPERIORITY||difference|8.7||||0.0145|TWO_SIDED|95.0|1.72|15.68|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D|Week 64||15.68|1.72|0.0145
91694634|NCT02915705|183284150|SUPERIORITY||difference|1.65|||<|0.0001|TWO_SIDED|95.0|1.28|2.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||2.02|1.28|< 0.0001
91694635|NCT02915705|183284150|SUPERIORITY||difference|1.42|||<|0.0001|TWO_SIDED|95.0|1.19|1.64|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||1.64|1.19|< 0.0001
91694636|NCT02915705|183284150|SUPERIORITY||difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.84|1.48|||GEE model|||Week 16||1.48|0.84|< 0.0001
91694637|NCT02915705|183284150|SUPERIORITY||difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.8|1.41|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||1.41|0.80|< 0.0001
91694638|NCT02915705|183284150|SUPERIORITY||difference|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||GEE model|||Week 32||1.51|0.98|< 0.0001
91694639|NCT02915705|183284150|SUPERIORITY||difference|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||1.60|1.10|< 0.0001
91694640|NCT02915705|183284150|SUPERIORITY||difference|1.26|||<|0.0001|TWO_SIDED|95.0|0.97|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||1.54|0.97|< 0.0001
91694641|NCT02915705|183284150|SUPERIORITY||difference|1.25|||<|0.0001|TWO_SIDED|95.0|0.96|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||1.54|0.96|< 0.0001
91694642|NCT02915705|183284152|SUPERIORITY||difference|-92.53|||<|0.0001|TWO_SIDED|95.0|-131.4|-53.66|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||-53.66|-131.40|< 0.0001
91694643|NCT02915705|183284152|SUPERIORITY||difference|-85.57|||<|0.0001|TWO_SIDED|95.0|-126.37|-44.76|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||-44.76|-126.37|< 0.0001
91694644|NCT02915705|183284152|SUPERIORITY||difference|-95.95|||<|0.0001|TWO_SIDED|95.0|-136.05|-55.84|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||-55.84|-136.05|< 0.0001
91528005|NCT03662997|182931050|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during first the week of treatment.|||||<|0.05||||||Five-layer vs Hydrocellular arm, first week of treatment|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
91694645|NCT02915705|183284152|SUPERIORITY||difference|-111.28|||<|0.0001|TWO_SIDED|95.0|-152.08|-70.49|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||-70.49|-152.08|< 0.0001
91694646|NCT02915705|183284152|SUPERIORITY||difference|-146.56|||<|0.0001|TWO_SIDED|95.0|-191.61|-101.52|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||-101.52|-191.61|< 0.0001
91694647|NCT02915705|183284155|SUPERIORITY||difference in LS means|-5.02||||0.0212|TWO_SIDED|95.0|-9.29|-0.75|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||-0.75|-9.29|0.0212
91694648|NCT02915705|183284155|SUPERIORITY||difference in LS means|2.68||||0.1009|TWO_SIDED|95.0|-0.52|5.89|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.89|-0.52|0.1009
91694649|NCT02915705|183284155|SUPERIORITY||difference in LS means|-3.25||||0.1676|TWO_SIDED|95.0|-7.86|1.37|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||1.37|-7.86|0.1676
91694650|NCT02915705|183284156|SUPERIORITY||difference in LS means|-2.26||||0.3091|TWO_SIDED|95.0|-6.61|2.09|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||2.09|-6.61|0.3091
91694651|NCT02915705|183284156|SUPERIORITY||difference in LS means|1.9||||0.3145|TWO_SIDED|95.0|-1.8|5.59|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.59|-1.80|0.3145
91694652|NCT02915705|183284156|SUPERIORITY||difference in LS means|-1.08||||0.681|TWO_SIDED|95.0|-6.21|4.06|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||4.06|-6.21|0.6810
91694653|NCT02915705|183284157|SUPERIORITY||Difference in LS Means|0.01||||0.9862|TWO_SIDED|95.0|-0.79|0.8|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.80|-0.79|0.9862
91694654|NCT02915705|183284158|SUPERIORITY||difference in LS means|0.05||||0.8786|TWO_SIDED|95.0|-0.58|0.68|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.68|-0.58|0.8786
91694655|NCT02915705|183284159|SUPERIORITY||difference in LS means|43.46||||0.0514|TWO_SIDED|95.0|-0.26|87.17|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||87.17|-0.26|0.0514
91694656|NCT02915705|183284160|SUPERIORITY||difference in LS means|45.55||||0.0399|TWO_SIDED|95.0|2.09|89.02|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||89.02|2.09|0.0399
91694657|NCT02915705|183284161|SUPERIORITY||difference in LS means|6.72||||0.0633|TWO_SIDED|95.0|-0.37|13.82|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||13.82|-0.37|0.0633
91724328|NCT01944774|183342784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.492||||0.423|TWO_SIDED|95.0|0.087|2.788||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.788|0.087|0.423
91528006|NCT03662997|182931050|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during the first week of treatment.|||||<|0.05||||||Five-layer vs Hydropolymer, first week of treatment.|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
91489953|NCT02100514|182852497|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.6|STANDARD_ERROR_OF_MEAN|3.59|<|0.001||95.0|-53.7|-39.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-53.7|<0.001
91489954|NCT02100514|182852497|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-39.7|STANDARD_ERROR_OF_MEAN|4.12||||95.0|-47.9|-31.6||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.6|-47.9|
91489955|NCT02100514|182852497|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.4|STANDARD_ERROR_OF_MEAN|4.02||||95.0|-41.3|-25.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-25.5|-41.3|
91489956|NCT02100514|182852498|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-30.8|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0|-36.9|-24.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-24.6|-36.9|<0.001
91489957|NCT02100514|182852498|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-27.5|STANDARD_ERROR_OF_MEAN|3.23||||95.0|-33.9|-21.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.2|-33.9|
91489958|NCT02100514|182852498|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.4|STANDARD_ERROR_OF_MEAN|18.27|||TWO_SIDED|95.0|-85.2|-13.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.5|-85.2|
91489959|NCT02100514|182852499|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.5|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|3.4|7.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.4|<0.001
91528007|NCT02761629|182931060|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.7||||0.0536|TWO_SIDED|95.0|-0.01|26.6|||Fisher Exact||Exact 95% confidence interval was from the binomial distribution for response rate.|||26.6|-0.01|0.0536
91724329|NCT01944774|183342785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.276||||0.118|TWO_SIDED|95.0|0.055|1.385||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.385|0.055|0.118
91489960|NCT02100514|182852499|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.4|STANDARD_ERROR_OF_MEAN|1.14||||95.0|3.2|7.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.2|
91489961|NCT02100514|182852499|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|6.0|STANDARD_ERROR_OF_MEAN|1.2||||95.0|3.6|8.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||8.3|3.6|
91489962|NCT02100514|182852500|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-44.2|STANDARD_ERROR_OF_MEAN|2.39||||95.0|-48.8|-39.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-39.5|-48.8|
91489963|NCT02100514|182852500|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-36.2|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-40.9|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-31.4|-40.9|
91489964|NCT02100514|182852501|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
91528008|NCT02761629|182931063|SUPERIORITY_OR_OTHER|||||||0.0175|||||||Fisher Exact|||||||0.0175
91528009|NCT00936221|182931077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3873|TWO_SIDED|80.0|0.67|1.28||1-sided p-value|Regression, Cox|Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.||If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.||1.28|0.67|0.3873
91528010|NCT03820323|182931081|SUPERIORITY||Risk Ratio (RR)|0.99||||0.55|TWO_SIDED|95.0|0.94|1.03|||Modified Poisson regression|||||1.03|0.94|0.55
91489965|NCT02100514|182852501|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
91528011|NCT03820323|182931082|SUPERIORITY||Risk Ratio (RR)|0.86||||0.28|TWO_SIDED|95.0|0.66|1.13|||Modified Poission regression|||||1.13|0.66|0.28
91694658|NCT02915705|183284162|SUPERIORITY||difference in LS means|7.27||||0.0496|TWO_SIDED|95.0|0.01|14.52|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||14.52|0.01|0.0496
91694659|NCT01022307|183284175|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis showed that the effect size was small, with a 50% chance of detecting a p \< 0.05 effect requiring 247 subjects.|||||<|0.04|TWO_SIDED||||||F-test|Greenhouse Geisser correction.||F-test evaluating effects of Group||||< 0.04
91694660|NCT04818034|183284176|OTHER|paired t-test|paired t-test|0.965|STANDARD_DEVIATION|37.0||0.965|ONE_SIDED|96.0|||||paired t-test|||||||0.965
91694661|NCT02186873|183284180|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|47.1|||<|0.001|TWO_SIDED|95.0|35.18|58.99|||Cochran-Mantel-Haenszel|||||58.99|35.18|<0.001
91694662|NCT01399047|183284205|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.105||||0.21|TWO_SIDED|95.0|-0.033|0.243|||Prescott's test||Mycophenolate was tolerated in 17/19 subjects (89.5%, 95% CI: 66.9% - 98.7%), while placebo was tolerated in 19/19 subjects (100%, 95% CI: 82.4% - 100%). The difference in tolerability rates was 10.5% (95% CI: -3.3% - 24.3%, p=0.21).|The primary outcome variable was tolerability, defined as the proportion of subjects able to complete 8 weeks on the assigned treatment. Tolerability was compared among the treatment groups using Prescott's test. A 95% confidence interval was computed for the tolerability of mycophenolate, placebo, and their difference.||0.243|-0.033|0.21
91694663|NCT01399047|183284206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.72|TWO_SIDED|95.0|-4.67|3.28|||Prescott's test|||||3.28|-4.67|0.72
91694664|NCT01399047|183284207|SUPERIORITY|||||||0.78|||||||Prescott's test|||||||0.78
91724330|NCT01944774|183342785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.644||||0.636|TWO_SIDED|95.0|0.104|3.999||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||3.999|0.104|0.636
91724331|NCT01944774|183342786|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.517||||0.456|TWO_SIDED|95.0|0.091|2.93||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.930|0.091|0.456
91724332|NCT01944774|183342786|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.508||||0.445|TWO_SIDED|95.0|0.09|2.883||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.883|0.090|0.445
91724333|NCT01944774|183342787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.518||||0.458|TWO_SIDED|95.0|0.091|2.941||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.941|0.091|0.458
91724334|NCT01944774|183342787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.667||||0.664|TWO_SIDED|95.0|0.107|4.144||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.144|0.107|0.664
91724335|NCT01944774|183342788|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.959|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.959
91724336|NCT01944774|183342788|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.961|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.961
91724337|NCT01944774|183342789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.96|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.960
91724338|NCT01944774|183342789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
91528012|NCT01844115|182931087|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.0048|TWO_SIDED|95.0|-3.72|-0.68|||MMRM|||||-0.68|-3.72|0.0048
91724339|NCT01944774|183342790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.95|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.950
91724340|NCT01944774|183342790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
91724341|NCT01944774|183342791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.949|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.949
91489966|NCT02100514|182852501|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
91489967|NCT02100514|182852502|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.1|STANDARD_ERROR_OF_MEAN|0.85||||95.0|2.5|5.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.8|2.5|
91489968|NCT02100514|182852502|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|3.8|STANDARD_ERROR_OF_MEAN|0.86||||95.0|2.2|5.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.5|2.2|
91489969|NCT02100514|182852502|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.3|STANDARD_ERROR_OF_MEAN|0.97||||95.0|2.4|6.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.2|2.4|
91489970|NCT02100514|182852503|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|1.1|STANDARD_ERROR_OF_MEAN|0.9||||95.0|-0.7|2.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.8|-0.7|
91489971|NCT02100514|182852503|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.9|STANDARD_ERROR_OF_MEAN|1.04||||95.0|-1.1|3.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.0|-1.1|
91489972|NCT02100514|182852503|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.8|STANDARD_ERROR_OF_MEAN|0.95||||95.0|-1.0|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|-1.0|
91489973|NCT02100514|182852504|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
91489974|NCT02100514|182852504|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
91489975|NCT02100514|182852504|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
91489976|NCT02100514|182852505|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.8|STANDARD_ERROR_OF_MEAN|3.18||||95.0|-73.0|-60.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-60.5|-73.0|
91528013|NCT01844115|182931088|SUPERIORITY||Least Squares Mean Difference|-1.89||||0.0236|TWO_SIDED|95.0|-3.52|-0.26|||MMRM|||||-0.26|-3.52|0.0236
91528014|NCT00545363|182931090|SUPERIORITY_OR_OTHER||||||=|0.8989|||||||ANOVA|||Statistical analysis was done to compare the participant satisfaction between the Biofeedback and No-feedback arms.||||=0.8989
91528015|NCT00545363|182931091|SUPERIORITY_OR_OTHER||||||=|0.453|||||||ANOVA|||Statistical analysis was done to compare the participant perception between the Biofeedback and No-feedback arms.||||=0.453
91694665|NCT01399047|183284208|SUPERIORITY|||||||0.98|||||||Prescott's test|||||||0.98
91694666|NCT01399047|183284209|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91694667|NCT04532619|183284223|SUPERIORITY||Slope|0.5||||0.014|TWO_SIDED|95.0|0.1|0.89||Computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.89|0.10|0.014
91694668|NCT04532619|183284224|SUPERIORITY||Slope|-0.05||||0.8|TWO_SIDED|95.0|-0.41|0.32||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.32|-0.41|0.80
91694669|NCT04532619|183284225|SUPERIORITY||Slope|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||-0.07|-0.51|0.009
91694670|NCT04532619|183284226|SUPERIORITY||Slope|0.17||||0.118|TWO_SIDED|95.0|-0.04|0.38||calculated p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.38|-0.04|0.118
91489977|NCT02100514|182852506|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.1|STANDARD_ERROR_OF_MEAN|5.4||||95.0|-76.7|-55.4||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.4|-76.7|
91489978|NCT02100514|182852507|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.5|STANDARD_ERROR_OF_MEAN|2.77||||95.0|-72.0|-61.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-61.1|-72.0|
91489979|NCT02100514|182852508|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-69.1|STANDARD_ERROR_OF_MEAN|3.08||||95.0|-75.2|-63.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.1|-75.2|
91489980|NCT02100514|182852509|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-71.3|STANDARD_ERROR_OF_MEAN|3.14||||95.0|-77.5|-65.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-65.1|-77.5|
91489981|NCT02100514|182852510|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-47.7|STANDARD_ERROR_OF_MEAN|2.12||||95.0|-51.9|-43.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.6|-51.9|
91489982|NCT02100514|182852511|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.4|STANDARD_ERROR_OF_MEAN|1.06||||95.0|-12.5|-8.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-8.3|-12.5|
91724342|NCT01944774|183342791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
91724343|NCT01944774|183342792|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.438||||0.491|TWO_SIDED|95.0|0.042|4.609||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.609|0.042|0.491
91489983|NCT02100514|182852512|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|2.6|STANDARD_ERROR_OF_MEAN|0.52||||95.0|1.6|3.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.6|1.6|
91489984|NCT02100514|182852513|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.08||||95.0|-1.8|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.8|
91489985|NCT02100514|182852513|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.1||||95.0|-1.6|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.6|
91489986|NCT02100514|182852513|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-1.6|-1.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.2|-1.6|
91694671|NCT04532619|183284227|SUPERIORITY||Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.24|TWO_SIDED|||||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology. A logistic link function was used for this binary outcome.||||.24
91724344|NCT01944774|183342792|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.531||||0.619|TWO_SIDED|95.0|0.044|6.444||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.444|0.044|0.619
91724345|NCT01944774|183342793|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.444||||0.501|TWO_SIDED|95.0|0.042|4.708||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.708|0.042|0.501
91724346|NCT01944774|183342793|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
91694672|NCT04532619|183284228|SUPERIORITY||Slope|-1.33||||0.43|TWO_SIDED|95.0|-4.64|1.98||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||1.98|-4.64|0.43
91724347|NCT01944774|183342794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.733||||0.807|TWO_SIDED|95.0|0.061|8.832||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.832|0.061|0.807
91694673|NCT04532619|183284229|SUPERIORITY||Slope|-2.06||||0.07|TWO_SIDED|95.0|-4.27|0.15||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.15|-4.27|0.07
91694674|NCT01515865|183284247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8||||0.3145|TWO_SIDED|95.0|-37.6|9.8|||Fisher Exact|||||9.8|-37.6|0.3145
91694675|NCT00386360|183284272|SUPERIORITY_OR_OTHER||LS Mean Difference|0.231||||0.7096|TWO_SIDED|95.0|-0.995|1.458|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.458|-0.995|0.7096
91694676|NCT00386360|183284273|SUPERIORITY_OR_OTHER||LS Mean Difference|0.543||||0.2973|TWO_SIDED|95.0|-0.485|1.571|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.571|-0.485|0.2973
91694677|NCT00386360|183284274|SUPERIORITY_OR_OTHER||LS Mean Difference|0.485||||0.1275|TWO_SIDED|95.0|-0.141|1.11|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.110|-0.141|0.1275
91694678|NCT00386360|183284275|SUPERIORITY_OR_OTHER||LS Mean Difference|0.664||||0.336|TWO_SIDED|95.0|-0.697|2.025|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.025|-0.697|0.3360
91694679|NCT00386360|183284276|SUPERIORITY_OR_OTHER||LS Mean Difference|0.334||||0.4565|TWO_SIDED|95.0|-0.551|1.219|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.219|-0.551|0.4565
91694680|NCT00386360|183284277|SUPERIORITY_OR_OTHER||LS Mean Difference|0.611||||0.0614|TWO_SIDED|95.0|-0.03|1.252|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.252|-0.030|0.0614
91694681|NCT00386360|183284278|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.9212|TWO_SIDED|95.0|-1.258|1.138|||ANOVA|LS means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.138|-1.258|0.9212
91724348|NCT01944774|183342794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
91724349|NCT01944774|183342795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.779|TWO_SIDED|95.0|0.058|8.445||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.445|0.058|0.779
91724350|NCT01944774|183342795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
91694682|NCT00386360|183284279|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|2.231|4.31|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||4.310|2.231|<0.0001
91528016|NCT00545363|182931092|SUPERIORITY_OR_OTHER||||||=|0.4917|||||||ANOVA|||Statistical analysis was done to compare the effect of adherence (Yes/No) on percent change from baseline in CTX between the Biofeedback and No-feedback arms.||||=0.4917
91724351|NCT03491917|183342842|NON_INFERIORITY|Non-inferiority margin is delta = 0.05.|||||<|0.01||||||The average difference in AUC was 0.023 (two-sided 95% CI: -0.012, 0.059; non-inferiority p \< 0.01 for non-inferiority margin delta = -0.05).|t-test, 2 sided|df: 417.0 for FFDM, 424.6 for DBT plus S-View, and (1, 18.9) for the difference.||The primary endpoint for this study was a non-inferior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) requiring correct lesion localization for DBT (digital breast tomosynthesis) plus S-View (synthesized view) versus FFDM (full field digital mammography). AUCs for each reader were estimated in each review condition based on per-subject probability of malignancy (POM) scores requiring correct lesion localization.||||<0.01
91724352|NCT03998462|183342855|SUPERIORITY||Mean Difference (Final Values)|1.85|STANDARD_ERROR_OF_MEAN|1.92||0.34|||||||Mixed Models Analysis|||||||0.34
91724353|NCT03998462|183342856|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|1.25||0.41|||||||Mixed Models Analysis|||||||0.41
91724354|NCT03998462|183342857|SUPERIORITY||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|1.05||0.71|||||||Mixed Models Analysis|||||||0.71
91724355|NCT05710224|183342858|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT Ratio (V181 / Butantan - DV) to be \>0.67.|GMT Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.76|0.99||p-value, GMT Ratio, and CI are calculated using t-distribution with the variance estimate from serotype specific linear model utilizing the natural log-transformed antibody titers as the response and a single term for vaccination group.|t-distribution|||DENV-1 GMT Ratio (V181/Butantan - DV)||0.99|0.76|<0.001
91724356|NCT05710224|183342858|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT Ratio (V181 / Butantan - DV) to be \>0.67.|GMT Ratio|7.1|||<|0.001|TWO_SIDED|95.0|6.03|8.35||p-value, GMT ratio, and CI are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody titers as the response and a single term for vaccination group.|t-distribution|||DENV-2 GMT Ratio (V181 / Butantan - DV)||8.35|6.03|<0.001
91724357|NCT05710224|183342858|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT Ratio (V181 / Butantan - DV) to be \>0.67.|GMT Ratio|0.45||||1|TWO_SIDED|95.0|0.39|0.53||p-value, GMT ratio, and CI were calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody titers as the response and a single term for vaccination group.|t- distribution|||DENV-3 GMT Ratio (V181 / Butantan - DV)||0.53|0.39|1.000
91724358|NCT05710224|183342858|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT Ratio (V181 / Butantan - DV) to be \>0.67.|GMT Ratio|0.35||||1|TWO_SIDED|95.0|0.29|0.42||p-value, GMT ratio, and CI were calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody titers as the response and a single term for vaccination group.|t-distribution|||DENV-4 GMT Ratio (V181 / Butantan - DV)||0.42|0.29|1.000
91528017|NCT03125941|182931132|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.49|2.05|||Chi-squared|||||2.05|0.49|1
91528018|NCT03125941|182931133|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
91724359|NCT05710224|183342859|NON_INFERIORITY|The statistical criterion for non-inferiority required the lower bound of the 2-sided 95% CI for the difference in percentages (V181 - Butantan-DV) to be \>-10 percentage points|Difference in Percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.8|1.3||p-value, estimated difference in percentage, and CI were calculated using the unstratified Miettinen \& Nurminen method|Miettinen & Nurminen method|||DENV-1 Difference in percentage (V181 - Butantan-DV)||1.3|-1.8|<0.001
91724360|NCT05710224|183342859|NON_INFERIORITY|The statistical criterion for non-inferiority required the lower bound of the 2-sided 95% CI for the difference in percentages (V181 - Butantan - DV) to be \>-10 percentage points.|Difference in Percentage|15.0|||<|0.001|TWO_SIDED|95.0|12.0|18.5||p-value, estimated difference in percentage, and CI were calculated using the unstratified Miettinen \& Nurminen method.|Miettinen & Nurminen method|||DENV-2 Difference in Percentage (V181 - Butantan-DV)||18.5|12.0|<0.001
91724361|NCT05710224|183342859|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (V181 - Butantan-DV) to be \>-10 percentage points.|Difference in percentage|-3.5|||<|0.001|TWO_SIDED|95.0|-5.8|-1.6||p-value, estimated difference in percentage, and CI are calculated using the unstratified Miettinen \& Nurminen method.|Miettinen & Nurminen method|||DENV-3 Difference in Percentage (V181 - Butantan-DV)||-1.6|-5.8|<0.001
91724362|NCT05710224|183342859|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (V181 - Butantan - DV) to be \>-10 percentage points.|Difference in Percentage|-3.6|||<|0.001|TWO_SIDED|95.0|-6.7|-0.8||p-value, estimated difference in percentage, and CI are calculated using the unstratified Miettinen \& Nurminen method.|Miettinen & Nurminen method|||DENV-4 Difference in Percentage (V181 - Butantan - DV)||-0.8|-6.7|<0.001
91724363|NCT05710224|183342861|OTHER|Estimated difference in percentage and CI were calculated using the unstratified Miettinen \& Nurminen method.|Difference in percentage|4.2|||||TWO_SIDED|95.0|1.4|7.2||||||Erythema: Difference in Percentage (V181-Butantan - DV)||7.2|1.4|
91528019|NCT03125941|182931134|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
91724364|NCT05710224|183342861|OTHER|Estimated difference in percentage and CI are calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-4.3|3.9||||||Pain: Difference in Percentage (V181 - Butantan - DV).||3.9|-4.3|
91724365|NCT05710224|183342861|OTHER|Estimated difference in percentage and CI are calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|0.6|||||TWO_SIDED|95.0|-1.1|2.3||||||Swelling: Difference in Percentage (V181 - Butantan - DV)||2.3|-1.1|
91724366|NCT05710224|183342862|OTHER|Estimated difference in percentage and CI were calculated using the unstratified Miettinen \& Nurminen method.|Difference in percentage|-1.1|||||TWO_SIDED|95.0|-5.5|3.3||||||Arthralgia: Difference in Percentage (V181 - Butantan - DV)||3.3|-5.5|
91724367|NCT05710224|183342862|OTHER|Estimated difference in percentage and CI are calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|-2.2|||||TWO_SIDED|95.0|-7.5|3.1||||||Fatigue: Difference in Percentage (V181 - Butantan - DV)||3.1|-7.5|
91724368|NCT05710224|183342862|OTHER|Estimated difference in percentage and CI are calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|-3.1|||||TWO_SIDED|95.0|-8.2|1.9||||||Headache: Difference in Percentage (V181 - Butantan - DV)||1.9|-8.2|
91724369|NCT05710224|183342862|OTHER|Estimated difference in percentage and CI were calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|-7.9|||||TWO_SIDED|95.0|-13.1|-2.7||||||Myalgia: Difference in Percentage (V181 - Butantan - DV)||-2.7|-13.1|
91724370|NCT05710224|183342862|OTHER|Estimated difference in percentage and CI are calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|-5.2|||||TWO_SIDED|95.0|-8.2|-2.3||||||Pyrexia: Difference in Percentage (V181 - Butantan - DV)||-2.3|-8.2|
91724371|NCT05710224|183342862|OTHER|Estimated difference in percentage and CI were calculated using the unstratified Miettinen \& Nurminen method.|Difference in Percentage|6.9|||||TWO_SIDED|95.0|1.9|11.8||||||Rash: Difference in Percentage (V181 - Butantan - DV)||11.8|1.9|
91489987|NCT02100514|182852514|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.4|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.4|
91724372|NCT04615507|183342885|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.00 logMAR for Distance.|Mean estimate|-0.132|STANDARD_ERROR_OF_MEAN|0.0201|||TWO_SIDED|95.0|-0.18|-0.083|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.083|-0.180|
91724373|NCT04615507|183342885|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Intermediate.|Mean estimate|-0.066|STANDARD_ERROR_OF_MEAN|0.0202|||TWO_SIDED|95.0|-0.115|-0.017|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.017|-0.115|
91528020|NCT03125941|182931137|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
91724374|NCT04615507|183342885|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Near.|Mean estimate|0.072|STANDARD_ERROR_OF_MEAN|0.0217|||TWO_SIDED|95.0|0.022|0.121|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||0.121|0.022|
91724375|NCT04615507|183342886|SUPERIORITY|The superiority of the Test lens will be concluded if the lower confidence limit of the LSM is above the predefined threshold 32 points.|Least-square mean|59.6|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|95.0|52.3|66.8|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom||||66.8|52.3|
91724376|NCT04615507|183342886|NON_INFERIORITY|The non-Inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above -5 points.|Least-square mean difference|5.5|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.9|10.2|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|LSM difference was calculated as Test minus Control|||10.2|0.9|
91724377|NCT05887401|183342901|SUPERIORITY|ITT analysis using linear mixed models comparing MVPA change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.|Mean Difference (Net)|61.45||||0.02|TWO_SIDED|95.0|9.95|112.95||The reported p-value reflects the change across time for the full sample.|Mixed Models Analysis|DF(2, 119)|The positive parameter estimate indicates an increase in MVPA over time for the full sample.|||112.95|9.95|0.02
91724378|NCT05887401|183342901|SUPERIORITY||Mean Difference (Net)|21.36||||0.65|TWO_SIDED|95.0|-70.89|113.61|||Mixed Models Analysis|DF(1, 69)|Green food monitoring (reference) vs red food monitoring; a positive estimation parameter indicates that the reference group had greater increases in MVPA over time.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on MVPA change over time (from baseline to 3 months).||113.61|-70.89|0.65
91724379|NCT05887401|183342901|SUPERIORITY||Mean Difference (Net)|-60.05||||0.2|TWO_SIDED|95.0|-152.4|32.39|||Mixed Models Analysis|DF(1,70)|Nutrition goals (yes; reference) vs no goals provided; a negative estimation parameter indicates that the non-referent group had greater increases in MVPA over time.|ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on MVPA change over time (from baseline to 3 months).||32.39|-152.40|0.20
91724380|NCT05887401|183342901|SUPERIORITY||Mean Difference (Net)|29.52||||0.53|TWO_SIDED|95.0|-63.07|122.11|||Mixed Models Analysis|DF(1,70)|Supportive text messages (yes; reference) vs no text messages; a positive estimation parameter indicates that the reference group had greater increases in MVPA over time.|ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on MVPA change over time (from baseline to 3 months).||122.11|-63.07|0.53
91528021|NCT03125941|182931138|SUPERIORITY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
91528022|NCT03125941|182931140|SUPERIORITY||||||>|0.193||||||a priori threshold, bonferroni corrected 0.0125|Wilcoxon (Mann-Whitney)|||||||>0.193
91694683|NCT00386360|183284280|SUPERIORITY_OR_OTHER||LS Mean Difference|1.444|||<|0.0001|TWO_SIDED|95.0|0.748|2.14|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.140|0.748|<0.0001
91694684|NCT00386360|183284281|SUPERIORITY_OR_OTHER||LS Mean Difference|1.408||||0.0036|TWO_SIDED|95.0|0.469|2.348|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.348|0.469|0.0036
91694685|NCT00386360|183284282|SUPERIORITY_OR_OTHER||LS Mean Difference|1.458||||0.0087|TWO_SIDED|95.0|0.375|2.541|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.541|0.375|0.0087
91694686|NCT00386360|183284283|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.54||||0.0002|TWO_SIDED|95.0|-59.957|-19.123|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-19.123|-59.957|0.0002
91694687|NCT00386360|183284284|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.269|||<|0.0001|TWO_SIDED|95.0|-51.3|-29.238|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-29.238|-51.300|<0.0001
91694688|NCT00386360|183284285|SUPERIORITY_OR_OTHER||LS Mean Difference|0.092||||0.1385|TWO_SIDED|95.0|-0.03|0.213|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||0.213|-0.030|0.1385
91694689|NCT03018080|183284295|OTHER|Estimation only.|Rate|0.238|||||TWO_SIDED|95.0|0.082|0.472|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.472|0.082|
91694690|NCT03018080|183284295|OTHER|Estimation only.|Rate|0.316|||||TWO_SIDED|95.0|0.126|0.566|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.566|0.126|
91694691|NCT03018080|183284296|OTHER|Estimation only|Rate|0.191|||||TWO_SIDED|95.0|0.055|0.419|||||Confidence interval estimated using the Clopper Pearson method.|||0.419|0.055|
91489988|NCT02100514|182852514|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
91694692|NCT03018080|183284296|OTHER|Estimation only.|Rate|0.421|||||TWO_SIDED|95.0|0.203|0.665|||||Confidence interval estimated using the Clopper Pearson method|||0.665|0.203|
91694693|NCT03018080|183284297|OTHER|Estimation only|Median|4.1|||||TWO_SIDED|95.0|1.4|6.9|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.9|1.4|
91694694|NCT03018080|183284297|OTHER|Estimation only|Median|3.9|||||TWO_SIDED|95.0|1.4|6.8|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.8|1.4|
91694695|NCT03018080|183284298|OTHER|Estimation only|Median|27.6|||||TWO_SIDED|95.0|9.7||Upper limit of the confidence interval is not reached due to censoring rate||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||9.7|
91694696|NCT03018080|183284298|OTHER|Estimation only|Median|9.0|||||TWO_SIDED|95.0|6.8|14.0|||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||14.0|6.8|
91724381|NCT05887401|183342901|SUPERIORITY||Mean Difference (Final Values)|-20.5||||0.66|TWO_SIDED|95.0|-113.26|72.27|||Mixed Models Analysis|DF(1,70)|Lesson delivery once (reference) vs weekly; a negative estimation parameter indicates that the non-referent group had greater increases in MVPA over time.|ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on MVPA change over time (from baseline to 3 months).||72.27|-113.26|0.66
91724382|NCT05887401|183342902|SUPERIORITY|ITT analysis using linear mixed models comparing self-reported MVPA change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.|Mean Difference (Net)|44.87||||0.004|TWO_SIDED|95.0|14.39|75.43|||Mixed Models Analysis|DF(2,127)|The positive parameter estimate indicates an increase in self-reported MVPA over time for the full sample.|||75.43|14.39|0.004
91724383|NCT05887401|183342902|SUPERIORITY||Mean Difference (Net)|-15.32||||0.47|TWO_SIDED|95.0|-58.96|28.32|||Mixed Models Analysis|DF(1,72)|Green food monitoring (reference) vs red food monitoring; a negative estimation parameter indicates that the non-referent group had greater increases in MVPA over time.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on self-reported MVPA change over time (from baseline to 3 months).||28.32|-58.96|0.47
91724384|NCT05887401|183342902|SUPERIORITY||Mean Difference (Net)|16.02||||0.47|TWO_SIDED|95.0|-27.67|59.7|||Mixed Models Analysis|DF(1,73)|Nutrition goals (yes; reference) vs no goals provided; a positive estimation parameter indicates that the reference group had greater increases in self-reported MVPA over time.|ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on self-reported MVPA change over time (from baseline to 3 months).||59.7|-27.67|0.47
91724385|NCT05887401|183342902|SUPERIORITY||Mean Difference (Net)|9.72||||0.66|TWO_SIDED|95.0|-34.09|53.52|||Mixed Models Analysis|DF(1,71)|Supportive text messages (yes; reference) vs no text messages; a positive estimation parameter indicates that the reference group had greater increases in self-reported MVPA over time.|ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on self-reported MVPA change over time (from baseline to 3 months).||53.52|-34.09|0.66
91724386|NCT05887401|183342902|SUPERIORITY||Mean Difference (Net)|-42.15||||0.06|TWO_SIDED|95.0|-86.04|1.73|||Mixed Models Analysis|DF(1,72)|Lesson delivery once (reference) vs weekly; a negative estimation parameter indicates that the non-referent group had greater increases in self-reported MVPA over time.|ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on self-reported MVPA change over time (from baseline to 3 months).||1.73|-86.04|0.06
91724387|NCT05887401|183342903|SUPERIORITY||Mean Difference (Net)|2.49||||0.109|TWO_SIDED|95.0|-0.56|5.54|||Mixed Models Analysis|DF(1,61)|The positive parameter estimate indicates an increase in HEI score over time for the full sample.|ITT analysis using linear mixed models comparing HEI score change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.||5.54|-0.56|0.109
91724388|NCT05887401|183342903|SUPERIORITY||Mean Difference (Net)|-1.17||||0.71|TWO_SIDED|95.0|-7.42|5.08|||Mixed Models Analysis|DF(1,68)|Green food monitoring (reference) vs red food monitoring; a negative estimation parameter indicates that the non-referent group had greater increases in HEI score.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on HEI score change over time (from baseline to 3 months).||5.08|-7.42|0.71
91489989|NCT02100514|182852514|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.4|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.4|
91489990|NCT02100514|182852515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.9||||||95.0|32.08|90.59||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||90.59|32.08|
91528023|NCT03125941|182931141|SUPERIORITY||||||>|0.2|||||||Wilcoxon (Mann-Whitney)|||||||>0.2
91489991|NCT02100514|182852515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.0||||||95.0|11.15|26.07||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||26.07|11.15|
91528024|NCT03125941|182931142|SUPERIORITY||||||>|0.136|||||||Chi-squared|||||||>0.136
91528025|NCT03125941|182931143|SUPERIORITY||||||>|0.003||||||A priori threshold for statistical significans was 0.00125 due to multiple comparisons|Chi-squared|||||||>0.003
91489992|NCT02100514|182852515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1||||||95.0|6.18|13.48||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||13.48|6.18|
91489993|NCT02100514|182852516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.4||||||95.0|48.84|501.11||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||501.11|48.84|
91489994|NCT02100514|182852516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|110.8||||||95.0|39.77|308.46||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||308.46|39.77|
91528026|NCT03125941|182931144|SUPERIORITY||Odds Ratio (OR)|3.53||||0.03|TWO_SIDED|95.0|1.07|11.6|||Chi-squared|||||11.6|1.07|0.030
91694697|NCT03018080|183284299|OTHER|Estimation only.|Rate|0.667|||||TWO_SIDED|95.0|0.43|0.854|||||Confidence interval estimated using the Clopper Pearson method|||0.854|0.430|
91694698|NCT03018080|183284299|OTHER|Estimation only|Rate|0.632|||||TWO_SIDED|95.0|0.384|0.837|||||Confidence interval estimated using the Clopper Pearson method|||0.837|0.384|
91489995|NCT02100514|182852516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.3||||||95.0|19.52|96.13||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||96.13|19.52|
91489996|NCT01751178|182852527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.061|||<|0.0001|TWO_SIDED|95.0|-0.081|-0.041||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two groups.||-0.041|-0.081|<0.0001
91489997|NCT01751178|182852527|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.09|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.050|-0.090|<0.0001
91528027|NCT00406419|182931158|SUPERIORITY||Weighted difference|18.5|||<|0.0001|TWO_SIDED|95.0|11.0|25.9|||Cochran-Mantel-Haenszel|||||25.9|11|< 0.0001
91528028|NCT00406419|182931158|SUPERIORITY||Weighted difference|21.4|||<|0.0001|TWO_SIDED|95.0|14.1|28.8|||Cochran-Mantel-Haenszel|||||28.8|14.1|< 0.0001
91528029|NCT00406419|182931159|SUPERIORITY||Weighted difference|30.8|||<|0.0001|TWO_SIDED|95.0|23.7|37.9|||Cochran-Mantel-Haenszel|||||37.9|23.7|< 0.0001
91694699|NCT03018080|183284300|OTHER|Estimation only|Median|7.3|||||TWO_SIDED|95.0|5.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|5.6|
91694700|NCT03018080|183284300|OTHER|Estimation only|Median|4.0|||||TWO_SIDED|95.0|2.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|2.6|
91694701|NCT03612596|183284302|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
91694702|NCT03612596|183284303|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
91694703|NCT03612596|183284304|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
91694704|NCT03612596|183284305|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91694705|NCT03612596|183284306|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91694706|NCT03612596|183284307|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.26) rather than test efficacy.||||||0.53
91724389|NCT05887401|183342903|SUPERIORITY||Mean Difference (Net)|0.44||||0.89|TWO_SIDED|95.0|-5.82|6.69|||Mixed Models Analysis|DF(1,68)|Nutrition goals (yes; reference) vs no goals provided; a positive estimation parameter indicates that the reference group had greater increases in HEI score over time.|ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on HEI score change over time (from baseline to 3 months).||6.69|-5.82|0.89
91694707|NCT03612596|183284308|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.16) rather than test efficacy.||||||0.44
91694708|NCT03612596|183284309|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 0.67) rather than test efficacy.||||||0.93
91724390|NCT05887401|183342903|SUPERIORITY||Mean Difference (Net)|3.66||||0.25|TWO_SIDED|95.0|-2.61|9.93|||Mixed Models Analysis|DF(1,68)|Supportive text messages (yes; reference) vs no text messages; a positive estimation parameter indicates that the reference group had greater increases in HEI score over time.|ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on HEI score change over time (from baseline to 3 months).||9.93|-2.61|0.25
91694709|NCT03612596|183284310|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
91694710|NCT03612596|183284311|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
91694711|NCT03612596|183284312|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91694712|NCT03612596|183284313|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
91694713|NCT03612596|183284314|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
91528030|NCT00406419|182931159|SUPERIORITY||Weighted difference|34.5|||<|0.0001|TWO_SIDED|95.0|27.4|41.5|||Cochran-Mantel-Haenszel|||||41.5|27.4|< 0.0001
91528031|NCT01461993|182931184|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82||||||95.0|0.72|0.94||||||HPV-6||0.94|0.72|
91528032|NCT01461993|182931184|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.91||||||HPV-11||0.91|0.74|
91528033|NCT01461993|182931184|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.88||||||HPV-16||0.88|0.68|
91528034|NCT01461993|182931184|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81||||||HPV-18||0.81|0.62|
91528035|NCT01461993|182931185|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.85|1.0||||||PMB80 \[A22\]||1.00|0.85|
91724391|NCT05887401|183342903|SUPERIORITY||Mean Difference (Net)|-1.83||||0.57|TWO_SIDED|95.0|-8.11|4.45|||Mixed Models Analysis|DF(1,68)|Lesson delivery once (reference) vs weekly; a negative estimation parameter indicates that the non-referent group had greater increases in HEI score over time.|ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on HEI score change over time (from baseline to 3 months).||4.45|-8.11|0.57
91724392|NCT02743494|183342986|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|96.4|0.56|0.86|||Stratified log-rank test||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.|||0.86|0.56|0.0003
91724393|NCT02743494|183342987|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1064|TWO_SIDED|95.0|0.07|1.03|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.|||1.03|0.070|0.1064
91724394|NCT01112267|183343067|SUPERIORITY_OR_OTHER|||||||0.0367|||||||Cochran-Mantel-Haenszel|p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups||||||0.0367
91724395|NCT01112267|183343068|SUPERIORITY_OR_OTHER|||||||0.0095||||||p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Mann-Whitney U test|||||||0.0095
91724396|NCT01112267|183343069|SUPERIORITY_OR_OTHER|||||||0.0202||||||p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0202
91724397|NCT01112267|183343069|SUPERIORITY_OR_OTHER|||||||0.0102||||||p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0102
91724398|NCT01112267|183343069|SUPERIORITY_OR_OTHER|||||||0.4652||||||p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.4652
91724399|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.3524||||||p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups|Wilcoxon (Mann-Whitney)|||||||0.3524
91724400|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.0224||||||p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0224
91724401|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.5712||||||p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.5712
91724402|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.0395||||||p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0395
91724403|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.0524||||||p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0524
91528036|NCT01461993|182931185|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.01||||||PMB2948 \[B24\]||1.01|0.84|
91724404|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.115||||||p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.115
91724405|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.7788||||||p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7788
91724406|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.7776||||||p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7776
91724407|NCT01112267|183343070|SUPERIORITY_OR_OTHER|||||||0.0047||||||p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0047
91724408|NCT01112267|183343071|SUPERIORITY_OR_OTHER|||||||0.0527||||||p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0527
91724409|NCT01112267|183343072|SUPERIORITY_OR_OTHER|||||||0.0917||||||p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.0917
91724410|NCT01112267|183343073|SUPERIORITY_OR_OTHER|||||||0.5632||||||p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.5632
91528037|NCT01121484|182931200|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||Null hypothesis: no difference between treatment groups||||0.004
91489998|NCT01751178|182852528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis that there was no difference between the two treatment groups.||-0.05|-0.10|<0.0001
91528038|NCT01121484|182931201|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.|Cochran-Mantel-Haenszel|||||||<0.001
91528039|NCT01121484|182931202|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
91694714|NCT04632069|183284329|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.4||0.009|TWO_SIDED||||||Regression, Linear|repeated measures linear regression: time periods: -14 to Day 0, Day 1-18(independent variable); daily po volumes (Dependent Variable)||Daily change in po feeding volumes expressed as po ml/kg/d \[reported as the mean daily change from Day 1 to 18 during NAC/NAC+taVNS minus baseline mean daily change Day -14 to day 0 (before treatment)\] Null hypothesis: there will be no significant difference in daily change in po feeding volume (ml/kg/d) from baseline to during treatment Power analysis: Estimated +0.2 ml/kg/d before taVNS, and +3ml/kg/d during the 18days of NAC+taVNS treatment, requiring 10 infants with power of 80%, a=0.05.||||0.009
91694715|NCT04632069|183284330|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.08||0.01|TWO_SIDED||||||t-test, 2 sided|paired t-test|mean difference between \[GSH\] Day 4 of NAC and \[GSH\] at baseline|\[GSH\] at baseline compared with \[GSH\] at day 4 of NAC- by paired t-test in which each participant's \[GSH\] is compared at 2 time points Null hypothesis: the \[GSH\] in the basal ganglia will be no different after Day 4 of NAC than \[GSH\] at baseline Power calculation:With 80% power, alpha of 0.05, we would need 7 patients to show a significant change in basal ganglia \[GSH\] of 0.14 +/- 0.13mM from baseline to Day 4 of NAC (paired t-test).||||0.01
91694716|NCT02573181|183284331|OTHER|Difference in percentage with AEs|Difference|4.2|||||TWO_SIDED|95.0|-7.4|15.8|||||Difference and 95% CI calculated based on Miettinen \& Nurminen method.|||15.8|-7.4|
91694717|NCT02573181|183284333|OTHER|Difference in % with fatigue|Fatigue difference|-0.9|||||TWO_SIDED|95.0|-10.7|8.8|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||8.8|-10.7|
91724411|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|115.78|||||TWO_SIDED|90.0|107.04|125.22|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.22|107.04|
91528040|NCT01121484|182931203|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
91724412|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Astellas Ratio|103.7|||||TWO_SIDED|90.0|95.91|112.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.12|95.91|
91724413|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|99.79|||||TWO_SIDED|90.0|92.3|107.89|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.89|92.30|
91724414|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio|103.65|||||TWO_SIDED|90.0|95.83|112.11|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and Cmax parameters||112.11|95.83|
91724415|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X100|101.7|||||TWO_SIDED|90.0|94.03|110.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and parameters||110.0|94.03|
91489999|NCT01751178|182852528|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.06||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.06|-0.11|<0.0001
91528041|NCT01121484|182931204|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.158
91694718|NCT02573181|183284333|OTHER|Difference in % with arthralgia|Arthralgia difference|-3.2|||||TWO_SIDED|95.0|-10.2|3.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||3.4|-10.2|
91694719|NCT02573181|183284333|OTHER|Difference in % with myalgia|Myalgia difference|4.6|||||TWO_SIDED|95.0|-3.9|13.3|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||13.3|-3.9|
91694720|NCT02573181|183284333|OTHER|Difference in % with headache|Headache difference|-2.5|||||TWO_SIDED|95.0|-11.4|6.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||6.4|-11.4|
91724416|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddys Ratio X 100|111.64|||||TWO_SIDED|90.0|103.26|120.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.70|103.26|
91724417|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|116.02|||||TWO_SIDED|90.0|107.27|125.49|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.49|107.27|
91528042|NCT01121484|182931205|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||<0.001
91694721|NCT03412734|183284340|OTHER||Odds Ratio (OR)|10.6|||<|0.001|TWO_SIDED|95.0|3.02|37.34||p-value is adjusted for baseline BV (Bacterial Vaginosis)|Regression, Logistic|||We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.||37.34|3.02|<0.001
91694722|NCT03777436|183284347|SUPERIORITY||Adjusted difference|20.1||||0.0003|TWO_SIDED|95.0|9.2|30.9|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||30.9|9.2|0.0003
91694723|NCT03777436|183284348|SUPERIORITY||Adjusted difference|15.2||||0.0004|TWO_SIDED|95.0|6.9|23.6|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||23.6|6.9|0.0004
91694724|NCT03777436|183284349|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|15.4|39.3|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||39.3|15.4|<0.0001
91694725|NCT03777436|183284350|SUPERIORITY||Least squares mean difference|-3.33|STANDARD_ERROR_OF_MEAN|0.942||0.0005|TWO_SIDED|95.0|-5.18|-1.47|||MMRM||Based on MMRM model.|||-1.47|-5.18|0.0005
91694726|NCT03777436|183284351|SUPERIORITY||Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0008|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Based on MMRM model.|||-1.1|-4.2|0.0008
91694727|NCT03777436|183284352|SUPERIORITY||Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-20.3|-10.0|||MMRM||Based on MMRM model.|||-10.0|-20.3|<0.0001
91694728|NCT01562782|183284423|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups in the primary outcome- the mean fold change in plasma VLDL triglyceride palmitate, 0-4 hours. A power calculation was based on data obtained in 15 overweight subjects. Assuming a mean absolute difference of 2.7 in South Asians and 1.0 in Caucasians and a standard deviation of 2.0 for both, group sample sizes of 16 and 16 were expected to achieve 80% power to detect a difference of 1.7 using a 2-sided Mann-Whitney test.|Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||Mixed Models Analysis|||The equivalence test was used to compare the fold change in plasma VLDL triglyceride palmitate in Caucasians and South Asians.||||0.05
91694729|NCT01562782|183284424|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test was used to compare 1) the fold change in triglycerides in South Asians and Caucasians and 2) the fold change in VLDL triglycerides in South Asians and Caucasians.||||<0.05
91694730|NCT01562782|183284425|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test is used to compare levels after the sugar beverage of 1) glucose at 1 hour 2) lactate at 1 hour 3) NEFA at 2 hours in South Asians vs Caucasians.||||<0.05
91694731|NCT01562782|183284426|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91528043|NCT05408468|182931246|SUPERIORITY||Mean Difference (Net)|-5.595|STANDARD_ERROR_OF_MEAN|1.731||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.731 One week 1.894|||||0.387
91694732|NCT01562782|183284427|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91724418|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|111.7|||||TWO_SIDED|90.0|103.27|120.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.81|103.27|
91724419|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|113.84|||||TWO_SIDED|90.0|105.3|123.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||123.08|105.30|
91528044|NCT05408468|182931246|SUPERIORITY||Mean Difference (Net)|-3.782|STANDARD_ERROR_OF_MEAN|2.048||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.048 One week 2.122|||||0.387
91528045|NCT05408468|182931247|SUPERIORITY||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|1.693||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.693 One week 1.840|||||0.062
91694733|NCT01562782|183284428|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||Pearson or Spearman's rank test|||The equivalence test was used to analyze the relationship between the primary outcome, fold change in VLDL TG palmitate, and the listed levels of biomarkers of carbohydrate and fat metabolism. The correlation analysis was performed on data from each study group separately.||||<0.05
91694734|NCT01562782|183284429|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91694735|NCT01562782|183284430|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91694736|NCT01562782|183284431|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91694737|NCT01562782|183284432|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91694738|NCT02649439|183284437|SUPERIORITY|||||||0.4852|||||||Wilcoxon signed rank test|||||||0.4852
91694739|NCT02649439|183284438|SUPERIORITY|||||||0.3269|||||||Wilcoxon signed rank test|||||||0.3269
91694740|NCT02649439|183284441|SUPERIORITY|||||||0.0255||||||The reported p-value is representative of the PBMCs in monocyte nonclassical between responders and non-responders.|Mann Whitney Test|||||||0.0255
91694741|NCT02649439|183284441|OTHER|||||||0.0021||||||The reported p-value is representative of the PBMCs in monocyte nonclassical PD-L1+ between responders and non-responders.|Mann Whitney Test|||||||0.0021
91694742|NCT02649439|183284441|SUPERIORITY|||||||0.0486||||||The reported p-value is representative of the PBMCs in monocyte PD-1+ between responders and non-responders.|Mann Whitney Test|||||||0.0486
91694743|NCT02649439|183284442|SUPERIORITY|||||||0.7317||||||The reported p-value is representative of the PBMCs in CD4 between responders and non-responders.|Mann Whitney Test|||||||0.7317
91694744|NCT02649439|183284442|SUPERIORITY|||||||0.7545||||||The reported p-value is representative of the PBMCs in CD8 between responders and non-responders.|Mann Whitney Test|||||||0.7545
91694745|NCT02649439|183284442|SUPERIORITY|||||||0.531||||||The reported p-value is representative of the PBMCs in Treg between responders and non-responders.|Mann Whitney Test|||||||0.5310
91694746|NCT02649439|183284442|SUPERIORITY|||||||0.8451||||||The reported p-value is representative of the PBMCs in NK between responders and non-responders.|Mann Whitney Test|||||||0.8451
91694747|NCT02649439|183284442|SUPERIORITY|||||||0.9377||||||The reported p-value is representative of the PBMCs in MDSC between responders and non-responders.|Mann Whitney Test|||||||0.9377
91694748|NCT02649439|183284443|SUPERIORITY|||||||0.2012||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.2012
91694749|NCT02649439|183284443|SUPERIORITY|||||||0.4891||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4891
91694750|NCT02649439|183284443|SUPERIORITY|||||||0.4609||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4609
91694751|NCT02649439|183284443|SUPERIORITY|||||||0.0012||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0012
91724420|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ratio X 100|103.92|||||TWO_SIDED|90.0|96.08|112.4|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.40|96.08|
91724421|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio x 100|100.05|||||TWO_SIDED|90.0|92.5|108.21|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||108.21|92.50|
91724422|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|101.97|||||TWO_SIDED|90.0|94.28|110.29|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.29|94.28|
91528046|NCT05408468|182931247|SUPERIORITY||Mean Difference (Net)|-0.764|STANDARD_ERROR_OF_MEAN|2.003||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.003 One week 2.069|||||0.062
91724423|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|96.28|||||TWO_SIDED|90.0|89.05|104.09|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.09|89.05|
91724424|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|98.12|||||TWO_SIDED|90.0|90.72|106.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||106.12|90.72|
91724425|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|101.92|||||TWO_SIDED|90.0|94.27|110.19|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.19|94.27|
91528047|NCT05408468|182931249|SUPERIORITY||Median Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.84||0.369|TWO_SIDED||||||t-test, 2 sided|||||||0.369
91528048|NCT05408468|182931250|SUPERIORITY||Median Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|3.79||0.498|TWO_SIDED||||||t-test, 2 sided|||||||0.498
91724426|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|109.75|||||TWO_SIDED|90.0|100.42|119.25|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||119.25|100.42|
91724427|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|99.76|||||TWO_SIDED|90.0|91.28|109.03|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||109.03|91.28|
91724428|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|101.63|||||TWO_SIDED|90.0|92.99|111.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.06|92.99|
91724429|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|106.2|||||TWO_SIDED|90.0|97.17|116.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||116.06|97.17|
91724430|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|104.09|||||TWO_SIDED|90.0|95.25|113.75|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||113.75|95.25|
91724431|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|110.02|||||TWO_SIDED|90.0|100.66|120.24|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.24|100.66|
91724432|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|108.0|||||TWO_SIDED|90.0|98.82|118.02|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||118.02|98.82|
91724433|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|103.34|||||TWO_SIDED|90.0|94.56|112.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.94|94.56|
91724434|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|105.44|||||TWO_SIDED|90.0|96.48|115.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||115.23|96.48|
91724435|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ration X 100|98.16|||||TWO_SIDED|90.0|89.82|107.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.28|89.82|
91724436|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|93.93|||||TWO_SIDED|90.0|85.96|102.65|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||102.65|85.96|
91724437|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|95.84|||||TWO_SIDED|90.0|87.69|104.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.74|87.69|
91724438|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|95.69|||||TWO_SIDED|90.0|87.56|104.58|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.58|87.56|
91724439|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|97.63|||||TWO_SIDED|90.0|89.34|107.71|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.71|89.34|
91724440|NCT02014103|183343074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Pancea/Sandoz Ratio X 100|102.03|||||TWO_SIDED|90.0|93.36|111.51|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.51|93.36|
91724441|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|141.91|||||TWO_SIDED|90.0|125.73|160.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||160.16|125.73|
91724442|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|104.13|||||TWO_SIDED|90.0|92.33|117.45|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||117.45|92.33|
91724443|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|116.02|||||TWO_SIDED|90.0|102.87|130.87|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.87|102.87|
91490000|NCT01751178|182852529|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.62||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.||-0.62|-0.98|<0.0001
91528049|NCT01396395|182931284|SUPERIORITY_OR_OTHER||Ratio|0.503|||<|0.0001|TWO_SIDED|95.0|0.435|0.581|||poisson regression: Non-calibration mode|||||0.581|0.435|<0.0001
91724444|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|108.92|||||TWO_SIDED|90.0|96.51|122.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||122.94|96.51|
91724445|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|94.06|||||TWO_SIDED|90.0|83.33|106.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||106.16|83.33|
91724446|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr. Reddys Ratio X 100|136.27|||||TWO_SIDED|90.0|120.82|153.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||153.70|120.82|
91724447|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|122.31|||||TWO_SIDED|90.0|108.37|138.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||138.04|108.37|
91724448|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|130.28|||||TWO_SIDED|90.0|115.43|147.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||147.04|115.43|
91724449|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|150.88|||||TWO_SIDED|90.0|133.77|170.18|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||170.18|133.77|
91724450|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Mylan Ratio X 100|89.75|||||TWO_SIDED|90.0|79.52|101.3|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||101.30|79.52|
91724451|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio X 100|95.6|||||TWO_SIDED|90.0|84.71|107.9|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.90|84.71|
91724452|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|110.72|||||TWO_SIDED|90.0|98.1|124.96|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||124.96|98.10|
91724453|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|106.52|||||TWO_SIDED|90.0|94.44|120.15|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||120.15|94.44|
91724454|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|123.36|||||TWO_SIDED|90.0|109.3|139.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||139.23|109.30|
91694752|NCT02649439|183284443|SUPERIORITY|||||||0.0825||||||The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0825
91694753|NCT02649439|183284443|SUPERIORITY|||||||0.5988||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5988
91694754|NCT02649439|183284443|SUPERIORITY|||||||0.592|||||||Wilcoxon signed rank test|The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.||||||0.5920
91694755|NCT02649439|183284443|SUPERIORITY|||||||0.6221||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.6221
91694756|NCT02649439|183284443|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
91724455|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|115.81|||||TWO_SIDED|90.0|102.68|130.62|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.62|102.68|
91694757|NCT02649439|183284443|OTHER|||||||0.791||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7910
91694758|NCT02649439|183284443|SUPERIORITY|||||||0.5186||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5186
91694759|NCT02649439|183284443|SUPERIORITY|The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.||||||0.5186|||||||Wilcoxon signed rank test|||||||0.5186
91694760|NCT02649439|183284443|SUPERIORITY|||||||0.9097||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.9097
91694761|NCT02649439|183284443|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
91694762|NCT00945035|183284451|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.02||||||90.0|0.97|1.07||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.07|0.97|
91694763|NCT00945035|183284452|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.03||||||90.0|0.95|1.11||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.11|0.95|
91694764|NCT00812981|183284490|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio of HI antibodies against the A/Indonesia/05/2005 strain between the two groups (1562902A CP Group over 1562902A NP Group), being below (\<) 2.0.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|0.99|||ANCOVA|||Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.||0.99|0.71|
91694765|NCT02589639|183284548|SUPERIORITY|The superiority of empagliflozin 10 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.11|-0.73|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment||"The statistical model was:~Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error"|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|-0.73|-1.11|<0.0001
91694766|NCT02589639|183284548|SUPERIORITY|The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.18|-0.82|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error||-0.82|-1.18|<0.0001
91694767|NCT02505217|183284603|SUPERIORITY|||||||0.007|||||||Regression, Cox|||||||0.007
91694768|NCT03517540|183284606|SUPERIORITY||Odds Ratio (OR)|0.8||||0.688|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.688
91694769|NCT03517540|183284606|SUPERIORITY||Odds Ratio (OR)|1.01||||0.985|TWO_SIDED|95.0|0.51|1.99|||Cochran-Mantel-Haenszel|||||1.99|0.51|0.985
91694770|NCT03517540|183284606|SUPERIORITY||Odds Ratio (OR)|0.92||||0.87|TWO_SIDED|95.0|0.3|2.84|||Cochran-Mantel-Haenszel|||||2.84|0.3|0.870
91694771|NCT03517540|183284606|SUPERIORITY||Odds Ratio (OR)|1.21||||0.71|TWO_SIDED|95.0|0.41|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.41|0.710
91694772|NCT03517540|183284607|SUPERIORITY||Odds Ratio (OR)|0.37||||0.136|TWO_SIDED|95.0|0.08|1.61|||Cochran-Mantel-Haenszel|||||1.61|0.08|0.136
91694773|NCT03517540|183284607|SUPERIORITY||Odds Ratio (OR)|0.83||||0.747|TWO_SIDED|95.0|0.24|2.9|||Cochran-Mantel-Haenszel|||||2.9|0.24|0.747
91694774|NCT03517540|183284607|SUPERIORITY||Odds Ratio (OR)|0.84||||0.784|TWO_SIDED|95.0|0.18|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.18|0.784
91694775|NCT03517540|183284607|SUPERIORITY||Odds Ratio (OR)|1.45||||0.521|TWO_SIDED|95.0|0.4|5.69|||Cochran-Mantel-Haenszel|||||5.69|0.4|0.521
91490001|NCT01751178|182852529|SUPERIORITY_OR_OTHER||Adusted Mean Difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.68||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.||-0.68|-1.04|<0.0001
91528050|NCT01396395|182931284|SUPERIORITY_OR_OTHER||Ratio|0.503|||=|0.0086|TWO_SIDED|95.0|0.301|0.84|||Poisson regression: Calibration model|||||0.840|0.301|=0.0086
91694776|NCT00615550|183284615|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92|||Cochran-Mantel-Haenszel|||||0.92|0.33|0.020
91528051|NCT02120664|182931301|SUPERIORITY_OR_OTHER||R squared|0.907|||||TWO_SIDED||||||Regression, Linear|||||||
91694777|NCT00615550|183284616|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Cochran-Mantel-Haenszel|||Statistical analysis presented for composite score data.||||0.048
91694778|NCT00615550|183284616|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39||||0.026|TWO_SIDED|95.0|0.17|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for RDS data.||0.92|0.17|0.026
91694779|NCT00615550|183284617|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.036|TWO_SIDED|95.0|0.25|0.97|||Cochran-Mantel-Haenszel|||Statistical analysis presented for births \<=27 6/7 weeks data.||0.97|0.25|0.036
91694780|NCT00615550|183284617|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.016|TWO_SIDED|95.0|0.42|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<= 34 6/7 weeks data.||0.92|0.42|0.016
91694781|NCT00615550|183284617|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<36 weeks data.||1.16|0.68|0.376
91694782|NCT00615550|183284618|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.431|TWO_SIDED|95.0|0.14|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.14|0.431
91694783|NCT00615550|183284619|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.26|0.85|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 1500 grams data.||0.85|0.26|0.01
91694784|NCT00615550|183284619|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.213|TWO_SIDED|95.0|0.62|1.11|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 2500 grams data.||1.11|0.62|0.213
91694785|NCT01408303|183284620|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-2.95|||<|0.05|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.05
91694786|NCT01408303|183284620|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-6.0|||<|0.0001|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.0001
91694787|NCT02644668|183284621|SUPERIORITY||Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.9086|TWO_SIDED|95.0|-0.13|0.11|||Mixed Models Analysis|||||0.11|-0.13|0.9086
91694788|NCT02644668|183284621|SUPERIORITY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.065||0.4361|TWO_SIDED|95.0|-0.18|0.08|||Mixed Models Analysis|||||0.08|-0.18|0.4361
91694789|NCT02644668|183284622|SUPERIORITY||Least squares mean difference|-2.94|STANDARD_ERROR_OF_MEAN|4.749||0.5382|TWO_SIDED|95.0|-12.43|6.55|||Mixed Models Analysis|||||6.55|-12.43|0.5382
91694790|NCT02644668|183284622|SUPERIORITY||Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|5.099||0.8464|TWO_SIDED|95.0|-9.19|11.18|||Mixed Models Analysis|||||11.18|-9.19|0.8464
91694791|NCT02644668|183284623|SUPERIORITY||Least squares mean difference|11.69|STANDARD_ERROR_OF_MEAN|5.506||0.0378|TWO_SIDED|95.0|0.68|22.7|||Mixed Models Analysis|||||22.70|0.68|0.0378
91694792|NCT02644668|183284623|SUPERIORITY||Least squares mean difference|13.15|STANDARD_ERROR_OF_MEAN|5.913||0.0298|TWO_SIDED|95.0|1.33|24.97|||Mixed Models Analysis|||||24.97|1.33|0.0298
91694793|NCT02644668|183284624|SUPERIORITY||Least squares mean difference|-4.59|STANDARD_ERROR_OF_MEAN|7.56||0.5461|TWO_SIDED|95.0|-19.69|10.52|||Mixed Models Analysis|||||10.52|-19.69|0.5461
91694794|NCT02644668|183284624|SUPERIORITY||Least squares mean difference|-15.23|STANDARD_ERROR_OF_MEAN|8.175||0.0672|TWO_SIDED|95.0|-31.56|1.11|||Mixed Models Analysis|||||1.11|-31.56|0.0672
91694795|NCT02644668|183284625|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.928||0.6849|TWO_SIDED|95.0|-2.23|1.48|||Mixed Models Analysis|||||1.48|-2.23|0.6849
91490002|NCT01751178|182852530|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.69||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two treatments.||-0.69|-1.07|<0.0001
91528052|NCT02120664|182931302|SUPERIORITY_OR_OTHER||Coefficient of Variation|2.53|||||TWO_SIDED|||||||||||||
91694796|NCT02644668|183284625|SUPERIORITY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.98||0.3091|TWO_SIDED|95.0|-2.96|0.95|||Mixed Models Analysis|||||0.95|-2.96|0.3091
91694797|NCT02644668|183284626|SUPERIORITY||Least squares mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.571||0.2878|TWO_SIDED|95.0|-0.53|1.75|||Mixed Models Analysis|||||1.75|-0.53|0.2878
91694798|NCT02644668|183284626|SUPERIORITY||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.616||0.8512|TWO_SIDED|95.0|-1.34|1.11|||Mixed Models Analysis|||||1.11|-1.34|0.8512
91694799|NCT02644668|183284627|SUPERIORITY||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|2.528||0.7612|TWO_SIDED|95.0|-6.08|4.52|||Mixed Models Analysis|||||4.52|-6.08|0.7612
91694800|NCT02644668|183284627|SUPERIORITY||Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|3.231||0.3502|TWO_SIDED|95.0|-9.91|3.7|||Mixed Models Analysis|||||3.70|-9.91|0.3502
91724456|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|112.96|||||TWO_SIDED|90.0|100.32|127.2|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.20|100.32|
91528053|NCT02120664|182931302|SUPERIORITY_OR_OTHER||Coefficient of Variation|6.69|||||TWO_SIDED|||||||||||||
91694801|NCT02644668|183284628|SUPERIORITY||Least squares mean difference|7.72|STANDARD_ERROR_OF_MEAN|10.484||0.4684|TWO_SIDED|95.0|-13.86|29.3|||Mixed Models Analysis|||||29.30|-13.86|0.4684
91694802|NCT02644668|183284628|SUPERIORITY||Least squares mean difference|24.89|STANDARD_ERROR_OF_MEAN|12.55||0.0584|TWO_SIDED|95.0|-0.95|50.74|||Mixed Models Analysis|||||50.74|-0.95|0.0584
91694803|NCT02644668|183284629|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1686|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||1.43|0.13|0.1686
91694804|NCT02644668|183284629|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5259|TWO_SIDED|95.0|0.2|2.3|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||2.30|0.20|0.5259
91694805|NCT02644668|183284630|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7655|TWO_SIDED|95.0|0.34|4.4|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||4.40|0.34|0.7655
91694806|NCT02644668|183284630|SUPERIORITY||Odds Ratio (OR)|1.61||||0.492|TWO_SIDED|95.0|0.41|6.25|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||6.25|0.41|0.4920
91694807|NCT05763875|183284642|SUPERIORITY||LS Mean Difference|-35.37|||<|0.0001|TWO_SIDED|95.0|-40.88|-29.86|||ANCOVA|||Treatment Policy Estimand||-29.86|-40.88|<0.0001
91694808|NCT05763875|183284642|SUPERIORITY||LS Mean Difference|-47.91|||<|0.0001|TWO_SIDED|95.0|-53.62|-42.2|||ANCOVA|||Treatment Policy Estimand||-42.20|-53.62|<0.0001
91694809|NCT05763875|183284642|SUPERIORITY||LS Mean Difference|-37.44|||<|0.0001|TWO_SIDED|95.0|-42.63|-32.26|||ANCOVA|||Monotherapy Estimand||-32.26|-42.63|<0.0001
91694810|NCT05763875|183284642|SUPERIORITY||LS Mean Difference|-50.9|||<|0.0001|TWO_SIDED|95.0|-56.51|-45.28|||ANCOVA|||Monotherapy Estimand||-45.28|-56.51|<0.0001
91694811|NCT05763875|183284643|SUPERIORITY||LS Mean Difference|-47.37|||<|0.0001|TWO_SIDED|95.0|-53.91|-40.72|||ANCOVA|||Treatment Policy Estimand||-40.72|-53.91|<0.0001
91694812|NCT05763875|183284643|SUPERIORITY||LS Mean Difference|-63.57|||<|0.0001|TWO_SIDED|95.0|-70.28|-56.87|||ANCOVA|||Treatment Policy Estimand||-56.87|-70.28|<0.0001
91694813|NCT05763875|183284643|SUPERIORITY||LS Mean Difference|-50.05|||<|0.0001|TWO_SIDED|95.0|-56.16|-43.94|||ANCOVA|||Monotherapy Estimand||-43.94|-56.16|<0.0001
91694814|NCT05763875|183284643|SUPERIORITY||LS Mean Difference|-67.51|||<|0.0001|TWO_SIDED|95.0|-74.09|-60.92|||ANCOVA|||Monotherapy Estimand||-60.92|-74.09|<0.0001
91694815|NCT05763875|183284644|SUPERIORITY||LS Mean Difference|-73.16|||<|0.0001|TWO_SIDED|95.0|-81.76|-64.56|||ANCOVA|||Treatment Policy Estimand||-64.56|-81.76|<0.0001
91694816|NCT05763875|183284644|SUPERIORITY||LS Mean Difference|-74.94|||<|0.0001|TWO_SIDED|95.0|-84.51|-65.37|||ANCOVA|||Treatment Policy Estimand||-65.37|-84.51|<0.0001
91694817|NCT05763875|183284644|SUPERIORITY||LS Mean Difference|-76.87|||<|0.0001|TWO_SIDED|95.0|-85.12|-68.62|||ANCOVA|||Monotherapy Estimand||-68.62|-85.12|<0.0001
91694818|NCT05763875|183284644|SUPERIORITY||LS Mean Difference|-79.47|||<|0.0001|TWO_SIDED|95.0|-88.77|-70.17|||ANCOVA|||Monotherapy Estimand||-70.17|-88.77|<0.0001
91694819|NCT05763875|183284645|SUPERIORITY||LS Mean Difference|-30.48|||<|0.0001|TWO_SIDED|95.0|-34.98|-25.98|||ANCOVA|||Treatment Policy Estimand||-25.98|-34.98|<0.0001
91694820|NCT05763875|183284645|SUPERIORITY||LS Mean Difference|-42.32|||<|0.0001|TWO_SIDED|95.0|-47.83|-36.82|||ANCOVA|||Treatment Policy Estimand||-36.82|-47.83|<0.0001
91694821|NCT05763875|183284645|SUPERIORITY||LS Mean Difference|-31.98|||<|0.0001|TWO_SIDED|95.0|-36.07|-27.89|||ANCOVA|||Monotherapy Estimand||-27.89|-36.07|<0.0001
91694822|NCT05763875|183284645|SUPERIORITY||LS Mean Difference|-44.86|||<|0.0001|TWO_SIDED|95.0|-50.28|-39.44|||ANCOVA|||Monotherapy Estimand||-39.44|-50.28|<0.0001
91694823|NCT05763875|183284646|SUPERIORITY||LS Mean Difference|-24.84|||<|0.0001|TWO_SIDED|95.0|-30.32|-19.36|||ANCOVA|||Treatment Policy Estimand||-19.36|-30.32|<0.0001
91694824|NCT05763875|183284646|SUPERIORITY||LS Mean Difference|-33.85|||<|0.0001|TWO_SIDED|95.0|-41.27|-26.44|||ANCOVA|||Treatment Policy Estimand||-26.44|-41.27|<0.0001
91694825|NCT05763875|183284646|SUPERIORITY||LS Mean Difference|-26.58|||<|0.0001|TWO_SIDED|95.0|-32.07|-21.09|||ANCOVA|||Monotherapy Estimand||-21.09|-32.07|<0.0001
91694826|NCT05763875|183284646|SUPERIORITY||LS Mean Difference|-36.06|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.67|||ANCOVA|||Monotherapy Estimand||-28.67|-43.46|<0.0001
91694827|NCT05763875|183284647|SUPERIORITY||LS Mean Difference|-28.98|||<|0.0001|TWO_SIDED|95.0|-33.3|-24.65|||ANCOVA|||Treatment Policy Estimand||-24.65|-33.30|<0.0001
91694828|NCT05763875|183284647|SUPERIORITY||LS Mean Difference|-36.66|||<|0.0001|TWO_SIDED|95.0|-41.1|-32.22|||ANCOVA|||Treatment Policy Estimand||-32.22|-41.10|<0.0001
91694829|NCT05763875|183284647|SUPERIORITY||LS Mean Difference|-30.16|||<|0.0001|TWO_SIDED|95.0|-34.08|-26.23|||ANCOVA|||Monotherapy Estimand||-26.23|-34.08|<0.0001
91724457|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|101.75|||||TWO_SIDED|90.0|90.37|114.57|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||114.57|90.37|
91724458|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astella Ratio X 100|113.52|||||TWO_SIDED|90.0|100.82|127.83|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.83|100.82|
91724459|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|99.16|||||TWO_SIDED|90.0|88.06|111.64|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||111.64|88.06|
91724460|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|95.57|||||TWO_SIDED|90.0|84.89|107.61|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.61|84.89|
91724461|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|111.01|||||TWO_SIDED|90.0|98.59|125.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||125.00|98.59|
91724462|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|99.51|||||TWO_SIDED|90.0|88.38|112.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||112.04|88.38|
91694830|NCT05763875|183284647|SUPERIORITY||LS Mean Difference|-38.78|||<|0.0001|TWO_SIDED|95.0|-43.12|-34.43|||ANCOVA|||Monotherapy Estimand||-34.43|-43.12|<0.0001
91694831|NCT05763875|183284648|SUPERIORITY||LS Mean Difference|-30.24|||<|0.0001|TWO_SIDED|95.0|-36.92|-23.57|||ANCOVA|||Treatment Policy Estimand||-23.57|-36.92|<0.0001
91694832|NCT05763875|183284648|SUPERIORITY||LS Mean Difference|-35.15|||<|0.0001|TWO_SIDED|95.0|-41.18|-29.12|||ANCOVA|||Treatment Policy Estimand||-29.12|-41.18|<0.0001
91694833|NCT05763875|183284648|SUPERIORITY||LS Mean Difference|-32.34|||<|0.0001|TWO_SIDED|95.0|-39.1|-25.59|||ANCOVA|||Monotherapy Estimand||-25.59|-39.10|<0.0001
91694834|NCT05763875|183284648|SUPERIORITY||LS Mean Difference|-37.38|||<|0.0001|TWO_SIDED|95.0|-43.44|-31.31|||ANCOVA|||Monotherapy Estimand||-31.31|-43.44|<0.0001
91694835|NCT05763875|183284649|SUPERIORITY||Ratio of Geometric Mean|0.757||||0.0002|TWO_SIDED|95.0|0.65|0.882|||ANCOVA|||Treatment Policy Estimand||0.882|0.650|0.0002
91694836|NCT05763875|183284649|SUPERIORITY||Ratio of Geometric Mean|0.748||||0.001|TWO_SIDED|95.0|0.622|0.898|||ANCOVA|||Treatment Policy Estimand||0.898|0.622|0.0010
91694837|NCT05763875|183284649|SUPERIORITY||Ratio of Geometric Mean|0.753|||<|0.0001|TWO_SIDED|95.0|0.652|0.871|||ANCOVA|||Monotherapy Estimand||0.871|0.652|<0.0001
91694838|NCT05763875|183284649|SUPERIORITY||Ratio of Geometric Mean|0.746||||0.0008|TWO_SIDED|95.0|0.622|0.893|||ANCOVA|||Monotherapy Estimand||0.893|0.622|0.0008
91694839|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-10.5|STANDARD_ERROR_OF_MEAN|8.5||0.2179|TWO_SIDED|95.0|-27.4|6.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||6.3|-27.4|0.2179
91694840|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-14.6|STANDARD_ERROR_OF_MEAN|8.5||0.0883|TWO_SIDED|95.0|-31.5|2.2|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||2.2|-31.5|0.0883
91694841|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-12.6|STANDARD_ERROR_OF_MEAN|8.5||0.1414|TWO_SIDED|95.0|-29.4|4.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||4.3|-29.4|0.1414
91694842|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|7.0||0.4514|TWO_SIDED|95.0|-19.1|8.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||8.6|-19.1|0.4514
91724463|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|113.93|||||TWO_SIDED|90.0|101.18|128.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.28|101.18|
91694843|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.212||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2120
91490003|NCT01751178|182852530|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.78||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two groups.||-0.78|-1.16|<0.0001
91490004|NCT04138810|182852531|NON_INFERIORITY|We defined the non-inferiority margin to be 5 points which with a sample of size of 25 women per arm would mean we would have a type I error rate of 0.05 and a power of 0.80.|Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-1.95|1.03||||||||1.03|-1.95|
91694844|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1057||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1057
91694845|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5241||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5241
91694846|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2773||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2773
91694847|NCT04015518|183284658|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.3867||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.3867
91724464|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|118.19|||||TWO_SIDED|90.0|104.96|133.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.08|104.96|
91694848|NCT04015518|183284659|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-6.1|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-19.3|7.1|||||Difference was calculated as Speso - placebo.|||7.1|-19.3|
91694849|NCT04015518|183284659|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-18.8|8.0|||||Difference was calculated as Speso - placebo.|||8.0|-18.8|
91694850|NCT04015518|183284659|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-3.5|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-16.6|9.7|||||Difference was calculated as Speso - placebo.|||9.7|-16.6|
91528054|NCT01351025|182931334|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 IL-6||||0.94
91694851|NCT04015518|183284659|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-9.4|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-20.3|1.4|||||Difference was calculated as Speso - placebo.|||1.4|-20.3|
91694852|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.1|STANDARD_ERROR_OF_MEAN|6.9||0.5595|TWO_SIDED|95.0|-17.7|9.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.6|-17.7|0.5595
91694853|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|0.9|STANDARD_ERROR_OF_MEAN|6.9||0.8968|TWO_SIDED|95.0|-12.7|14.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||14.5|-12.7|0.8968
91694854|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.2|STANDARD_ERROR_OF_MEAN|6.9||0.5456|TWO_SIDED|95.0|-17.9|9.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.5|-17.9|0.5456
91694855|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-7.7|STANDARD_ERROR_OF_MEAN|5.7||0.1762|TWO_SIDED|95.0|-19.0|3.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||3.5|-19.0|0.1762
91694856|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1726||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1726
91694857|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2353||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2353
91694858|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1346||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1346
91724465|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan|89.64|||||TWO_SIDED|90.0|79.61|100.93|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||100.93|79.61|
91724466|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|102.63|||||TWO_SIDED|90.0|91.15|115.55|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||115.55|91.15|
91724467|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Sandoz Ratio X 100|106.46|||||TWO_SIDED|90.0|94.55|119.88|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||119.88|94.55|
91490005|NCT03285984|182852539|SUPERIORITY||Mean Difference (Net)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.27|-0.15||From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline|ANCOVA||Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment|||-0.15|-0.27|<.0001
91490006|NCT00413244|182852541|SUPERIORITY_OR_OTHER|||||||0.03|||||||log mean|||"Statistician used all the time points post-baseline together (Overall). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline."||||0.03
91528055|NCT01351025|182931335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sun test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD4+ T-cell activation percent (% CD38+/DR+ of CD4)||||0.495
91694859|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.195||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1950
91694860|NCT04015518|183284660|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1681||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1681
91694861|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2812|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.5|-1.8|0.2812
91694862|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3357|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.6|-1.7|0.3357
91694863|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1809|TWO_SIDED|95.0|-2.0|0.4|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.4|-2.0|0.1809
91694864|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8322|TWO_SIDED|95.0|-1.1|0.9|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.9|-1.1|0.8322
91694865|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4035||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4035
91724468|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|114.49|||||TWO_SIDED|90.0|110.68|128.92|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.92|110.68|
91528056|NCT01351025|182931336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.704|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 D-dimer||||0.704
91694866|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2563||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2563
91694867|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.681||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.6810
91694868|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4665||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4665
91694869|NCT04015518|183284661|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5565||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5565
91694870|NCT04015518|183284662|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.17|0.281|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.281|-0.170|
91694871|NCT04015518|183284662|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.195|||||TWO_SIDED|95.0|-0.048|0.432|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.432|-0.048|
91694872|NCT04015518|183284662|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.27|||||TWO_SIDED|95.0|0.02|0.496|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.496|0.020|
91694873|NCT04015518|183284662|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.129|||||TWO_SIDED|95.0|-0.067|0.314|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.314|-0.067|
91724469|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|118.77|||||TWO_SIDED|90.0|105.48|133.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.74|105.48|
91528057|NCT01351025|182931337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.508|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD8+ T-cell activation percent (% CD38+/DR+ of CD8+)||||0.508
91694874|NCT04015518|183284662|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0613||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0613
91724470|NCT02014103|183343075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|103.74|||||TWO_SIDED|90.0|92.13|116.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||116.81|92.13|
91724471|NCT05638737|183343077|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|7.5||||0.893|TWO_SIDED|95.0|-4.1|20.5|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline ALT as covariate. Model uses log-scaled variables.||||20.5|-4.1|0.893
91724472|NCT05638737|183343078|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|-0.9||||0.396|TWO_SIDED|95.0|-7.5|6.1|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline Pro-C3 as covariate. Model uses log-scaled variables||||6.1|-7.5|0.396
91724473|NCT03712852|183343120|SUPERIORITY||Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.68|1.17|||||||Multiple univariate analyses for each variable were performed. GT was analyzed by non-parametric Cliff's delta tests to assess group dominance and by a Heteroscedastic ANOVA with Games-Howell posthoc tests. A sensitivities analysis with different types of robust analyses (M-estimators and High Breakdown LTS Estimators, both with Huber's, Hampel's and Biweight's loss functions) was conducted to get an effect-size estimate by means of Bootstrap Bias Corrected and accelerated (BCa) 95% Confidence Intervals.|1.17|0.68|
91724474|NCT03712852|183343121|SUPERIORITY||Median Difference (Final Values)|3.28|||||TWO_SIDED|95.0|3.0|3.55|||||||This outcome was analyzed by posthoc Nemenyi's tests|3.55|3.00|
91724475|NCT03712852|183343122|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.46|2.46|||||||This outcome was analyzed by posthoc Nemenyi's tests|2.46|-0.46|
91724476|NCT03712852|183343123|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.4|0.69|||||||This outcome was analyzed by posthoc Nemenyi's tests|0.69|-0.40|
91724477|NCT03712852|183343124|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|2.96|3.81|||||||CAL was analyzed with both Nemenyi's tests and a Moderated Regression (Treatment by Baseline values)|3.81|2.96|
91724478|NCT04307394|183343132|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
91724479|NCT00447278|183343152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.36|||<|0.001|TWO_SIDED|95.0|-6.47|-2.25||P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.|Mixed Models Analysis|Mixed model repeated measure analysis with terms for corresponding baseline T-score, treatment, country, visit, and treatment-by-visit interaction.|Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.25|-6.47|<0.001
91724480|NCT00447278|183343152|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.56|-2.63||P-value for Change from Baseline: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.63|-6.56|<0.001
91724481|NCT00447278|183343153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.002|TWO_SIDED|95.0|-5.08|-1.13||P-value for Change from Baseline: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.13|-5.08|0.002
91724482|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.002|TWO_SIDED|95.0|-4.92|-1.15||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.15|-4.92|0.002
91724483|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.1||||0.031|TWO_SIDED|95.0|-4.01|-0.2||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.20|-4.01|0.031
91724484|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55||||0.629|TWO_SIDED|95.0|-1.68|2.77||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.77|-1.68|0.629
91724485|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.421|TWO_SIDED|95.0|-3.3|1.38||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.38|-3.30|0.421
91724486|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05||||0.388|TWO_SIDED|95.0|-3.44|1.34||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.34|-3.44|0.388
91724487|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.29||||0.059|TWO_SIDED|95.0|-4.66|0.09||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.09|-4.66|0.059
91724488|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56||||0.006|TWO_SIDED|95.0|-6.09|-1.04||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.04|-6.09|0.006
91528058|NCT02066896|182931346|OTHER|ANOVA repeated measures||||||0.05|||||||ANOVA|ANOVA repeated measures||||||0.05
91528059|NCT03469284|182931371|OTHER|||||||0.0034|||||||ANOVA|||||||0.0034
91724489|NCT00447278|183343154|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.91||||0.027|TWO_SIDED|95.0|-5.49|-0.33||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.33|-5.49|0.027
91724490|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.073||||0.015|TWO_SIDED|95.0|0.014|0.131||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.131|0.014|0.015
91724491|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.004|TWO_SIDED|95.0|0.027|0.143||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.027|0.004
91724492|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.094||||0.063|TWO_SIDED|95.0|-0.005|0.192||P-value for Home Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.192|-0.005|0.063
91724493|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.075||||0.131|TWO_SIDED|95.0|-0.022|0.172||P-value for Home Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.172|-0.022|0.131
91724494|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.052||||0.156|TWO_SIDED|95.0|-0.02|0.124||P-value for Daily Living Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.124|-0.020|0.156
91724495|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072||||0.046|TWO_SIDED|95.0|0.001|0.143||P-value for Daily Living Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.001|0.046
91724496|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04||||0.068|TWO_SIDED|95.0|-0.003|0.084||P-value for Risk Taking Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.084|-0.003|0.068
91724497|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.028||||0.212|TWO_SIDED|95.0|-0.016|0.073||P-value for Risk Taking Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.073|-0.016|0.212
91528060|NCT03469284|182931372|OTHER|||||||0.0008|||||||ANOVA|||||||0.0008
91724498|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.121||||0.006|TWO_SIDED|95.0|0.034|0.208||P-value for School Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.208|0.034|0.006
91724499|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236||P-value for School Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.236|0.064|<0.001
91724500|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125||||0.034|TWO_SIDED|95.0|0.009|0.24||P-value for Self-Concept Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.240|0.009|0.034
91724501|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.119||||0.04|TWO_SIDED|95.0|0.005|0.233||P-value for Self-Concept Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.233|0.005|0.040
91724502|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.042|TWO_SIDED|95.0|0.003|0.166||p-value for Social Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.166|0.003|0.042
91724503|NCT00447278|183343155|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.048||||0.271|TWO_SIDED|95.0|-0.038|0.134||P-value for Social Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.134|-0.038|0.271
91724504|NCT00447278|183343156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.307||||0.034|TWO_SIDED|95.0|0.173|4.44||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.440|0.173|0.034
91724505|NCT00447278|183343156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.072||||0.005|TWO_SIDED|95.0|0.942|5.202||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||5.202|0.942|0.005
91724506|NCT00447278|183343156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.721||||0.004|TWO_SIDED|95.0|0.544|2.899||P-value for Inattention Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.899|0.544|0.004
91724507|NCT00447278|183343156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.269|||<|0.001|TWO_SIDED|95.0|1.086|3.453||P-value for Inattention Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.453|1.086|<0.001
91724508|NCT00447278|183343156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58||||0.298|TWO_SIDED|95.0|-0.515|1.676||P-value for Hyperactivity Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.676|-0.515|0.298
91724509|NCT00447278|183343156|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.865||||0.119|TWO_SIDED|95.0|-0.225|1.956||P-value for Hyperactivity Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.956|-0.225|0.119
91724510|NCT00447278|183343157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.104||||0.366|TWO_SIDED|95.0|-0.122|0.329||P-value for Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.329|-0.122|0.366
91724511|NCT00447278|183343157|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.169||||0.165|TWO_SIDED|95.0|-0.07|0.407||P-value for Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.407|-0.070|0.165
91724512|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.35||||0.054|TWO_SIDED|95.0|-4.74|0.04||P-value for Achievement Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.04|-4.74|0.054
91724513|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.71||||0.003|TWO_SIDED|95.0|-6.16|-1.26||P-value for Achievement Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.26|-6.16|0.003
91724514|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.74||||0.033|TWO_SIDED|95.0|-3.33|-0.14||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.14|-3.33|0.033
91724515|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5||||0.003|TWO_SIDED|95.0|-4.12|-0.88||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.88|-4.12|0.003
91528061|NCT03469284|182931374|OTHER|||||||0.9182|||||||Fisher Exact|||||||0.9182
91528062|NCT03469284|182931375|OTHER|||||||0.1046|||||||Fisher Exact|||||||0.1046
91724516|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5||||0.623|TWO_SIDED|95.0|-1.5|2.5||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.50|-1.50|0.623
91724517|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16||||0.88|TWO_SIDED|95.0|-1.96|2.29||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.29|-1.96|0.880
91490007|NCT02319837|182852557|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.424|||<|0.0001|TWO_SIDED|95.0|0.296|0.607||Statistical significance can be declared if p-value \<0.05.|Log Rank|||||0.607|0.296|<0.0001
91694875|NCT04015518|183284662|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0628||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0628
91694876|NCT04015518|183284662|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1449||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1449
91694877|NCT04015518|183284662|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.046||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0460
91724518|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.149|TWO_SIDED|95.0|-3.31|0.5||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.50|-3.31|0.149
91724519|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.78||||0.003|TWO_SIDED|95.0|-4.58|-0.98||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-4.58|0.003
91724520|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.62||||0.015|TWO_SIDED|95.0|-4.71|-0.52||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.52|-4.71|0.015
91724521|NCT00447278|183343158|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12||||0.004|TWO_SIDED|95.0|-5.26|-0.98||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-5.26|0.004
91724522|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.39||||0.263|TWO_SIDED|95.0|-1.83|6.6||P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||6.60|-1.83|0.263
91724523|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38||||0.848|TWO_SIDED|95.0|-3.6|4.36||P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.36|-3.60|0.848
91724524|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19||||0.895|TWO_SIDED|95.0|-3.01|2.64||P-value for Statisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.64|-3.01|0.895
91724525|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.2||||0.038|TWO_SIDED|95.0|-6.22|-0.19||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.19|-6.22|0.038
91724526|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.854|TWO_SIDED|95.0|-3.59|2.98||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.98|-3.59|0.854
91724527|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.26||||0.161|TWO_SIDED|95.0|-5.45|0.92||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.92|-5.45|0.161
91724528|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7||||0.54|TWO_SIDED|95.0|-2.98|1.58||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.58|-2.98|0.540
91490008|NCT02319837|182852558|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.631||||0.0049|TWO_SIDED|95.0|0.456|0.871||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.871|0.456|0.0049
91724529|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.98||||0.106|TWO_SIDED|95.0|-4.4|0.44||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.44|-4.40|0.106
91724530|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.833|TWO_SIDED|95.0|-2.49|3.08||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.08|-2.49|0.833
91724531|NCT00447278|183343159|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.54||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.54|-5.21|0.110
91724532|NCT03677401|183343161|SUPERIORITY|P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.158|||||||Cochran-Mantel-Haenszel|||At Week 10||||0.158
91724533|NCT03677401|183343162|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.75|||||||Cochran-Mantel-Haenszel|||At Week 4||||0.750
91724534|NCT03677401|183343163|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation||||||0.674|||||||Cochran-Mantel-Haenszel|||At Week 2||||0.674
91724535|NCT03677401|183343164|SUPERIORITY|P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.06|||||||ANCOVA|||At Week 2||||0.060
91724536|NCT03677401|183343164|SUPERIORITY|||||||0.401||||||P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.401
91724537|NCT03677401|183343164|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.185|||||||ANCOVA|||At Week 6||||0.185
91724538|NCT03677401|183343164|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.164|||||||ANCOVA|||At Week 10||||0.164
91724539|NCT03677401|183343165|SUPERIORITY|||||||0.283||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.283
91724540|NCT03677401|183343165|SUPERIORITY|||||||0.701||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.701
91724541|NCT03677401|183343165|SUPERIORITY|||||||0.033||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.033
91724542|NCT03677401|183343166|SUPERIORITY|||||||0.797||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.797
91724543|NCT03677401|183343167|SUPERIORITY|||||||0.845||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.845
91724544|NCT03677401|183343168|SUPERIORITY|||||||0.385||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.385
91724545|NCT03677401|183343168|SUPERIORITY|||||||0.786||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.786
91724546|NCT03677401|183343168|SUPERIORITY|||||||0.502||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.502
91724547|NCT03677401|183343169|SUPERIORITY|||||||0.197||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.197
91724548|NCT03677401|183343169|SUPERIORITY|||||||0.694||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.694
91724549|NCT03677401|183343169|SUPERIORITY|||||||0.916||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.916
91724550|NCT02810327|183343173|OTHER|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||The MUSC Bioinformatics Core analyzed group genomic data for variant association with COPD severity score, including single variant association or type of variant association with symptoms. Descriptive statistical analysis was performed using statistical package SAS 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).||||0.054
91724551|NCT06262607|183343174|SUPERIORITY||Least square (LS) mean difference|6.0|STANDARD_ERROR_OF_MEAN|7.74||0.4422|TWO_SIDED|95.0|-9.54|21.53|||Mixed Models Repeated Measures (MMRM)|||||21.53|-9.54|0.4422
91724552|NCT01692756|183343183|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||0.33
91724553|NCT01692756|183343184|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
91724554|NCT01692756|183343185|SUPERIORITY|||||||0.93|||||||Kruskal-Wallis|||||||0.93
91724555|NCT01692756|183343186|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
91724556|NCT01692756|183343187|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
91724557|NCT01692756|183343188|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||.003
91724558|NCT01692756|183343189|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||.007
91724559|NCT01692756|183343190|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|||||||.63
91724560|NCT01692756|183343191|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
91724561|NCT01692756|183343192|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
91724562|NCT01692756|183343193|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||.02
91724563|NCT01692756|183343194|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||.20
91724564|NCT01692756|183343195|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
91724565|NCT04925934|183343204|SUPERIORITY||Rate Difference|2.8|||=|0.7474|TWO_SIDED|90.0|-11.4|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.4|=0.7474
91724566|NCT04925934|183343204|SUPERIORITY||Rate Difference|-0.1|||=|0.9942|TWO_SIDED|90.0|-14.2|14.1|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||14.1|-14.2|=0.9942
91724567|NCT04925934|183343205|SUPERIORITY||Rate Difference|37.2|||=|0.1626|TWO_SIDED|90.0|-0.3|74.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||74.7|-0.3|=0.1626
91724568|NCT04925934|183343205|SUPERIORITY||Rate Difference|24.1|||=|0.2873|TWO_SIDED|90.0|-7.5|55.8|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||55.8|-7.5|=0.2873
91724569|NCT04925934|183343206|SUPERIORITY||Rate Difference|8.6|||=|0.322|TWO_SIDED|90.0|-5.6|22.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||22.7|-5.6|=0.3220
91724570|NCT04925934|183343206|SUPERIORITY||Rate Difference|2.9|||=|0.7364|TWO_SIDED|90.0|-11.2|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.2|=0.7364
91724571|NCT04925934|183343207|SUPERIORITY||Rate Difference|11.7|||=|0.2805|TWO_SIDED|90.0|-6.1|29.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||29.4|-6.1|=0.2805
91724572|NCT04925934|183343207|SUPERIORITY||Rate Difference|9.4|||=|0.3926|TWO_SIDED|90.0|-8.6|27.3|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||27.3|-8.6|=0.3926
91724573|NCT04925934|183343208|SUPERIORITY||Rate Difference|16.5|||=|0.037|TWO_SIDED|90.0|4.0|29.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||29.0|4.0|=0.0370
91724574|NCT04925934|183343208|SUPERIORITY||Rate Difference|4.9|||=|0.4939|TWO_SIDED|90.0|-6.7|16.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||16.4|-6.7|=0.4939
91490009|NCT02319837|182852559|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.068|||<|0.0001|TWO_SIDED|95.0|0.033|0.141||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.141|0.033|<0.0001
91490010|NCT02319837|182852559|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.331|||<|0.0001|TWO_SIDED|95.0|0.226|0.486||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.486|0.226|<0.0001
91724575|NCT04425018|183343220|SUPERIORITY||Risk Difference (RD)|11.6||||0.188|TWO_SIDED|95.0|-5.8|29.0|||Fisher Exact||"Estimate and corresponding Wald 95% confidence interval of the difference in pCR response rates (%) between the Paclitaxel + Pertuzumab + Margetuximab and Paclitaxel + Pertuzumab + Trastuzumab arms."|||29.0|-5.8|0.188
91724576|NCT04425018|183343221|SUPERIORITY||Risk Difference (RD)|18.9||||0.0715|TWO_SIDED|95.0|-2.2|40.1|||Fisher Exact||"Estimate and corresponding Wald 95% confidence interval of the difference in pCR response rates (%) between the Paclitaxel + Pertuzumab + Margetuximab and Paclitaxel + Pertuzumab + Trastuzumab arms among HR+ subjects"|||40.1|-2.2|0.0715
91724577|NCT04425018|183343222|SUPERIORITY||Risk Difference (RD)|-5.2||||0.7754|TWO_SIDED|95.0|-36.5|26.1|||Fisher Exact||"Estimate and corresponding Wald 95% confidence interval of the difference in pCR response rates (%) between the Paclitaxel + Pertuzumab + Margetuximab and Paclitaxel + Pertuzumab + Trastuzumab arms among HR- subjects."|||26.1|-36.5|0.7754
91724578|NCT01327703|183343255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.|Treatment difference|-2.08||||0.459|TWO_SIDED|95.0|-7.23|4.02||As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Mixed Models Analysis|||Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.||4.02|-7.23|0.4590
91724579|NCT00849472|183343285|SUPERIORITY_OR_OTHER||Percentage of participants|17.98|||||TWO_SIDED|95.0|10.64|27.55|||||The estimated value (EV) represents the percentage of participants with pCR. Participants with missing data were excluded from the denominator (n=89; 4 participants with missing data) for the calculation of the EV.|||27.55|10.64|
91724580|NCT05942040|183343300|OTHER|Pre-post test|Odds Ratio (OR)|0.7|STANDARD_ERROR_OF_MEAN|0.18||0.17|TWO_SIDED|95.0|0.43|1.16|||Regression, Logistic|||||1.16|0.43|0.17
91724581|NCT06461455|183343308|NON_INFERIORITY|Non-inferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.011|||ONE_SIDED|95.0||0.04||Since a non-inferiority hypothesis is being tested, confidence limit is more appropriate than p-value in assessing the results against the predefined non-inferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and lens sequence) and random (subject) effects. Difference=LID230451-ULTRA MFfA. Sign is retained with the rounded value.|||0.04||
91724582|NCT03010501|183343361|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
91724583|NCT03010501|183343362|SUPERIORITY|||||||0.1||||||According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.10
91724584|NCT03010501|183343362|SUPERIORITY|||||||0.15||||||According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.15
91724585|NCT03010501|183343363|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
91694878|NCT04015518|183284662|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0677||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0677
91724586|NCT02347787|183343367|SUPERIORITY|||||||0.3|||||||Regression, Linear|||Determination of targeted sample size was based on detecting a between-arm difference in mean change in SF-12 Physical Component Summary of 3 points, which is the minimal clinically significant difference for this instrument. To achieve at least 80% power with a type I error rate of 5%, we required 444 total participants. To account for 25% attrition, we aimed to accrue 592 participants.||||0.30
91724587|NCT02347787|183343368|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-1.3|0.9|||Regression, Linear|||||0.9|-1.3|0.21
91724588|NCT02347787|183343369|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-0.7|0.4|||Regression, Linear|||||0.4|-0.7|0.21
91724589|NCT02347787|183343370|SUPERIORITY||Risk Difference (RD)|-0.5||||0.21|TWO_SIDED|95.0|-2.2|1.2|||Regression, Linear|||||1.2|-2.2|0.21
91724590|NCT02347787|183343371|SUPERIORITY||Risk Difference (RD)|-6.3||||0.21|TWO_SIDED|95.0|-14.3|1.8|||Regression, Linear|||||1.8|-14.3|0.21
91724591|NCT02347787|183343372|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
91724592|NCT02347787|183343373|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91724593|NCT02347787|183343374|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||||1.5|0.6|0.98
91724594|NCT02347787|183343376|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91724595|NCT02347787|183343377|SUPERIORITY|||||||0.02|||||||Regression, Logistic|||||||0.02
91724596|NCT02347787|183343378|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
91724597|NCT02347787|183343380|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||0.09
91724598|NCT02347787|183343381|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
91724599|NCT01917773|183343382|NON_INFERIORITY_OR_EQUIVALENCE|"Reported MIs and SDs in healthy volunteers from an adult study were used to calculate sample size (1). A sample size of 13 patients was deemed adequate to detect a 25% change in MI with 80% power.~Reference: Rao SS, Kavelock R, Beaty J, Ackerson K, et al. Effects of fat and carbohydrate meals on colonic motor response. Gut. Feb 2000;46(2):205-211."||||||0.087|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P \<0.05.||||0.087
91724600|NCT01917773|183343382|SUPERIORITY_OR_OTHER|||||||0.552|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P \<0.05.||||0.552
91724601|NCT01917773|183343382|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P \<0.05.||||0.807
91724602|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6346|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.6346
91490011|NCT02319837|182852560|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.358|||<|0.0001|TWO_SIDED|95.0|0.263|0.488||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.488|0.263|<0.0001
91724603|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2757|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.2757
91724604|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.1321
91724605|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5543|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.5543
91724606|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3940
91724607|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.7891
91724608|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.4829
91724609|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4526|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.4526
91490012|NCT02319837|182852560|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.411|0.709||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.709|0.411|<0.0001
91528063|NCT01242176|182931376|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.67|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.1|105.37|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV).|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.37|98.10|
91724610|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.2485
91490013|NCT02319837|182852562|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.443||||0.0002|TWO_SIDED|95.0|0.284|0.69|||Log Rank|||||0.690|0.284|0.0002
91490014|NCT02319837|182852562|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.614||||0.0171|TWO_SIDED|95.0|0.409|0.92|||Log Rank|||||0.920|0.409|0.0171
91490015|NCT02319837|182852563|OTHER||difference of percentage of participants|25.9|||<|0.0001|TWO_SIDED|95.0|20.7|31.0||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||31.0|20.7|<0.0001
91490016|NCT02319837|182852563|OTHER||difference of percentage of participants|18.8|||<|0.0001|TWO_SIDED|95.0|13.0|24.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||24.6|13.0|<0.0001
91724611|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6252|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.6252
91724612|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.4003
91724613|NCT00544882|183343394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.8841
91724614|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8892|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.8892
91724615|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7678|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.7678
91724616|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.5782
91724617|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8083|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.8083
91724618|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||1.0000
91724619|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4122|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.4122
91724620|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.6675
91724621|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8445|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.8445
91724622|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3772|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.3772
91724623|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.1918
91724624|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.6675
91724625|NCT00544882|183343396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9226|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.9226
91724626|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0979|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.0979
91724627|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.0629
91724628|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.8464
91724629|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6316|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.6316
91724630|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3000
91724631|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.0955
91724632|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1523|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 25 time point.||||0.1523
91724633|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2809|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.2809
91724634|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 28 time point.||||0.8829
91724635|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9262|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.9262
91724636|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7811|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 -Day 4 time point.||||0.7811
91724637|NCT00544882|183343397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3703|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.3703
91490017|NCT02319837|182852564|OTHER||difference of percentage of participants|7.5||||0.0439|TWO_SIDED|95.0|-0.2|15.2||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||15.2|-0.2|0.0439
91490018|NCT02319837|182852564|OTHER||difference of percentage of participants|-12.9||||0.0004|TWO_SIDED|95.0|-19.8|-6.1||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-6.1|-19.8|0.0004
91724638|NCT00308685|183343403|OTHER||Difference in adjusted means|5.163||||0.0002|TWO_SIDED|95.0|2.478|7.847||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.||7.847|2.478|0.0002
91724639|NCT01121575|183343435|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|69.25|||||TWO_SIDED|90.0|54.22|88.44|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||88.44|54.22|
91724640|NCT01121575|183343436|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|78.84|||||TWO_SIDED|90.0|58.9|105.54|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUC10 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC10 was based on data from 6 participants. No statistical analysis was performed for PF-06260182.||105.54|58.90|
91724641|NCT01121575|183343438|SUPERIORITY_OR_OTHER||Ration of adjust geometric mean|70.6|||||TWO_SIDED|90.0|54.71|91.12|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||91.12|54.71|
91724642|NCT01121575|183343441|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|117.81|||||TWO_SIDED|90.0|64.97|213.61|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||213.61|64.97|
91759988|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-29.34|-10.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-10.06|-29.34|
91759989|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.65|||||TWO_SIDED|95.0|-22.25|-3.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.04|-22.25|
91759990|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.6|||||TWO_SIDED|95.0|-17.24|2.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.04|-17.24|
91759991|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-28.99|-9.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.68|-28.99|
91759992|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.17|||||TWO_SIDED|95.0|3.18|19.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||19.16|3.18|
91759993|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.19|||||TWO_SIDED|95.0|-0.78|15.15||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.15|-0.78|
91724643|NCT01121575|183343442|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|121.9|||||TWO_SIDED|90.0|70.2|211.66|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUC24 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC24 was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||211.66|70.20|
91724644|NCT01121575|183343444|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|130.57|||||TWO_SIDED|90.0|82.46|206.73|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||206.73|82.46|
91724645|NCT02583269|183343452|OTHER|||||||0.76|||||||ANOVA|||Overall FACT G score p value baseline to week 8||||0.76
91490019|NCT02319837|182852565|OTHER||difference of percentage of participants|7.2||||0.0089|TWO_SIDED|95.0|1.7|12.8||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||12.8|1.7|0.0089
91490020|NCT02319837|182852565|OTHER||difference of percentage of participants|-5.0||||0.0326|TWO_SIDED|95.0|-9.4|-0.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-0.6|-9.4|0.0326
91528064|NCT01242176|182931377|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|99.46|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|90.18|109.68|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||109.68|90.18|
91694879|NCT04015518|183284663|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|-0.069|0.256|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.256|-0.069|
91694880|NCT04015518|183284663|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.188|||||TWO_SIDED|95.0|0.018|0.405|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.405|0.018|
91694881|NCT04015518|183284663|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.102|||||TWO_SIDED|95.0|-0.042|0.303|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.303|-0.042|
91694882|NCT04015518|183284663|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.113|||||TWO_SIDED|95.0|-0.018|0.25|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.250|-0.018|
91694883|NCT04015518|183284663|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0536||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0536
91724646|NCT02583269|183343452|OTHER|||||||0.25|||||||ANOVA|||Fact G functional well being p value baseline to week 8||||0.25
91724647|NCT02583269|183343452|OTHER|||||||0.18|||||||ANOVA|||FACT G emotional well being p value baseline to week 8||||0.18
91724648|NCT02583269|183343452|OTHER|||||||0.87|||||||ANOVA|||Fact G physical well being p value baseline to week 8||||0.87
91724649|NCT02583269|183343452|OTHER|||||||0.22|||||||ANOVA|||Fact G social well being p value baseline to week 8||||0.22
91490021|NCT02319837|182852566|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.693|||<|0.0001|TWO_SIDED|95.0|0.577|0.834|||Log Rank|||||0.834|0.577|<0.0001
91724650|NCT02583269|183343460|OTHER|||||||0.67|||||||ANOVA|||||||0.67
91490022|NCT02319837|182852566|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.655|||<|0.0001|TWO_SIDED|95.0|1.381|1.984|||Log Rank|||||1.984|1.381|<0.0001
91724651|NCT02583269|183343461|OTHER|||||||0.119|||||||ANOVA|||Baseline v. 4 weeks log IL-8||||0.119
91724652|NCT02583269|183343461|OTHER|||||||0.414|||||||ANOVA|||Baseline v. 8 weeks log IL-8||||0.414
91724653|NCT02583269|183343462|OTHER|||||||0.851|||||||ANOVA|||Baseline v. 4 weeks p value log VEGF||||0.851
91528065|NCT01242176|182931378|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.8|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.26|105.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.48|98.26|
91724654|NCT02583269|183343462|OTHER|||||||0.688|||||||ANOVA|||Baseline vs. 8 weeks p value log VEGF||||0.688
91724655|NCT03244189|183343465|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||||1.20|0.77|
91724656|NCT03244189|183343466|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.37||||||||1.37|0.72|
91724657|NCT03244189|183343467|OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.91|2.29||||||||2.29|0.91|
91724658|NCT04167670|183343519|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|-0.3||||0.0037|TWO_SIDED|95.0|-7.39|6.76|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan dual therapy to lansoprazole triple therapy.||6.76|-7.39|0.0037
91724659|NCT04167670|183343519|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|5.9|||<|0.0001|TWO_SIDED|95.0|-0.75|12.62|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan triple therapy to lansoprazole triple therapy.||12.62|-0.75|<0.0001
91724660|NCT04167670|183343520|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|37.7|||<|0.0001|TWO_SIDED|95.0|20.54|52.56|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||52.56|20.54|<0.0001
91724661|NCT04167670|183343520|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|33.8|||<|0.0001|TWO_SIDED|95.0|17.74|48.12|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan triple therapy to lansoprazole triple therapy.||48.12|17.74|<0.0001
91724662|NCT04167670|183343521|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|8.7||||0.0063|TWO_SIDED|95.0|1.86|15.44|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||15.44|1.86|0.0063
91724663|NCT04167670|183343521|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|12.3||||0.0001|TWO_SIDED|95.0|5.72|18.81|||Farrington and Manning test|||Superiority of vonoprazan triple therapy to lansoprazole triple therapy.|The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|18.81|5.72|0.0001
91724664|NCT05399485|183343528|SUPERIORITY||[Difference in Least square (LS) Mean]|-1.1||||0.0021|TWO_SIDED|95.0|-1.73|-0.38|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as a covariate, treatment group, randomization stratum (stable prophylactic migraine medication use throughout randomization), month, and month-by treatment group interaction as fixed effects.||-0.38|-1.73|0.0021
91528066|NCT00358215|182931379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.871|TWO_SIDED|95.0|0.9|1.13||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none)|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.13|0.90|0.871
91724665|NCT05399485|183343529|SUPERIORITY||Difference in Percentage|7.3||||0.0989|TWO_SIDED|95.0|-1.4|15.9||P-value \>0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel|||The percentages of participants with reductions were compared between treatment groups using Mantel-Haenszel risk estimation with stratification by randomization stratum (stable prophylactic migraine medication use throughout randomization; yes, no).||15.9|-1.4|0.0989
91759994|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-8.28|7.65||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.65|-8.28|
91759995|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-6.14|9.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.61|-6.14|
91759996|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.11|||||TWO_SIDED|95.0|5.51|22.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.71|5.51|
91759997|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.27|||||TWO_SIDED|95.0|-3.38|13.92||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.92|-3.38|
91724666|NCT02642679|183343574|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we had 95% power to detect an improvement of 2 points in VAS score assuming a common standard deviation of 1 point with a two sided two sample t-test each at alpha=0.17 level.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in pain. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
91724667|NCT02642679|183343575|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 80% power to detect an improvement in re-epithelialization from 14.6 days to 10 days assuming a common standard deviation of 2.9 days.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing rate. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
91724668|NCT02642679|183343576|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 95% power to detect an improvement of 2 points in VSS score assuming a common standard deviation of 1 point.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing quality. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
91694884|NCT04015518|183284663|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0476||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0476
91724669|NCT06059066|183343612|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure immediately after received intradetrusor BTX-A injections||||0.57
91724670|NCT06059066|183343612|OTHER|||||||0.83||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure asses 6-weeks after intradetrusor BTX-A injections||||0.83
91724671|NCT06059066|183343613|OTHER|||||||0.59||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total ICIQ-SF score assessed before and 6-weeks after treatment||||0.59
91694885|NCT04015518|183284663|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1076||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1076
91694886|NCT04015518|183284663|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0606||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0606
91694887|NCT04015518|183284663|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0824||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0824
91694888|NCT04015518|183284664|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.211|||||TWO_SIDED|95.0|0.04|0.422|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.422|0.040|
91694889|NCT04015518|183284664|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.018|0.339|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.339|-0.018|
91694890|NCT04015518|183284664|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.125|||||TWO_SIDED|95.0|-0.022|0.328|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.328|-0.022|
91694891|NCT04015518|183284664|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.144|||||TWO_SIDED|95.0|0.009|0.282|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.282|0.009|
91694892|NCT04015518|183284664|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0333||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0333
91694893|NCT04015518|183284664|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0221||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regime"||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0221
91705367|NCT01306214|183305230|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|H0: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo \>0.3 Ha: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo ≤0.3||-0.13|-0.62|<0.0001
91694894|NCT04015518|183284664|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0707||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0707
91724672|NCT06059066|183343613|OTHER|||||||0.29||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in ICIQ QoL score assessed before and 6-weeks after treatment||||0.29
91724673|NCT06059066|183343614|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total NBSS-SF score assessed before and 6-weeks after treatment||||0.57
91724674|NCT06059066|183343614|OTHER|||||||0.42||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF QoL score assessed before and 6-weeks after treatment||||0.42
91724675|NCT06059066|183343614|OTHER|||||||0.24||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF incontinence domain score assessed before and 6-weeks after treatment||||0.24
91528067|NCT00358215|182931380|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.512|TWO_SIDED|95.0|0.92|1.19||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.19|0.92|0.512
91724676|NCT06059066|183343614|OTHER|||||||0.93||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF storage and voiding domain score assessed before and 6-weeks after treatment||||0.93
91724677|NCT06059066|183343614|OTHER|||||||0.64||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF consequences domain score assessed before and 6-weeks after treatment||||0.64
91724678|NCT06059066|183343615|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||||||0.21
91724679|NCT06059066|183343616|OTHER||||||<|2e-05||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Change in post-procedural pain as compared to baseline||||<0.00002
91724680|NCT03928704|183343720|SUPERIORITY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|95.0|2.0|6.16|||Regression, Logistic|||||6.16|2.00|<0.001
91528068|NCT00358215|182931381|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.922|TWO_SIDED|95.0|0.89|1.14||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.14|0.89|0.922
91724681|NCT03928704|183343721|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.71|5.54|||Regression, Logistic|||||5.54|1.71|<0.001
91724682|NCT03928704|183343722|SUPERIORITY||LS Mean difference|-1.51|||<|0.001||95.0|-2.04|-0.98|||ANCOVA|||||-0.98|-2.04|<0.001
91724683|NCT03928704|183343722|SUPERIORITY||LS Mean difference|-0.91||||0.22|TWO_SIDED|95.0|-2.42|0.61|||ANCOVA|||||0.61|-2.42|0.220
91724684|NCT03928704|183343723|SUPERIORITY||Odds Ratio (OR)|3.69|||<|0.001|TWO_SIDED|95.0|2.17|6.26|||Regression, Logistic|||||6.26|2.17|<0.001
91724685|NCT03928704|183343724|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.001|TWO_SIDED|95.0|2.06|9.93|||Regression, Logistic|||||9.93|2.06|<0.001
91724686|NCT03928704|183343725|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.41|12.23|||Regression, Logistic|||||12.23|2.41|<0.001
91724687|NCT03928704|183343726|SUPERIORITY||Odds Ratio (OR)|3.31|||<|0.001|TWO_SIDED|95.0|1.87|5.84|||Regression, Logistic|||||5.84|1.87|<0.001
91724688|NCT03928704|183343727|SUPERIORITY||LS Mean difference|-1.48|||<|0.001||95.0|-1.99|-0.97|||ANCOVA|||||-0.97|-1.99|<0.001
91724689|NCT03928704|183343727|SUPERIORITY||LS Mean difference|-1.25||||0.019|TWO_SIDED|95.0|-2.26|-0.24|||ANCOVA|||||-0.24|-2.26|0.019
91724690|NCT03928704|183343728|SUPERIORITY||LS Mean difference|-1.8|||<|0.001||95.0|-2.42|-1.18|||ANCOVA|||||-1.18|-2.42|<0.001
91724691|NCT03928704|183343728|SUPERIORITY||LS Mean difference|-1.09||||0.199|TWO_SIDED|95.0|-2.83|0.65|||ANCOVA|||||0.65|-2.83|0.199
91724692|NCT03928704|183343729|SUPERIORITY||LS Mean difference|-2.63|||<|0.001||95.0|-3.66|-1.61|||ANCOVA|||||-1.61|-3.66|<0.001
91490023|NCT02319837|182852567|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.09|||<|0.0001|TWO_SIDED|95.0|0.051|0.157|||Log Rank|||||0.157|0.051|<0.0001
91490024|NCT02319837|182852568|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.546|||<|0.0001|TWO_SIDED|95.0|0.427|0.699|||Log Rank|||||0.699|0.427|<0.0001
91724693|NCT03928704|183343729|SUPERIORITY||LS Mean difference|-1.84||||0.17|TWO_SIDED|95.0|-4.56|0.89|||ANCOVA|||||0.89|-4.56|0.170
91724694|NCT03928704|183343730|SUPERIORITY||LS Mean difference|3.96|||<|0.001|TWO_SIDED|95.0|2.08|5.83|||ANCOVA|||||5.83|2.08|<0.001
91724695|NCT03928704|183343730|SUPERIORITY||LS Mean difference|7.27||||0.035|TWO_SIDED|95.0|0.6|13.95|||ANCOVA|||||13.95|0.60|0.035
91724696|NCT03928704|183343731|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|<0.001
91724697|NCT03928704|183343731|SUPERIORITY||LS Mean difference|-0.5||||0.086|TWO_SIDED|95.0|-1.07|0.07|||ANCOVA|||||0.07|-1.07|0.086
91724698|NCT03928704|183343732|SUPERIORITY||LS Mean difference|-1.06|||=|0.013|TWO_SIDED|95.0|-1.88|-0.23|||ANCOVA|||||-0.23|-1.88|=0.013
91490025|NCT02319837|182852568|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.619|||<|0.0001|TWO_SIDED|95.0|0.488|0.785|||Log Rank|||||0.785|0.488|<0.0001
91694895|NCT04015518|183284664|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0578||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0578
91724699|NCT03928704|183343733|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.84|6.62|||Regression, Logistic|||||6.62|1.84|<0.001
91724700|NCT04764539|183343787|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|0.294|<|0.555|TWO_SIDED|95.0|-1.276|0.796||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The Mean Length of Utterance (MLU) will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||0.796|-1.276|<0.555
91490026|NCT02319837|182852569|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.261||||0.0001|TWO_SIDED|95.0|0.125|0.548|||Log Rank|||||0.548|0.125|0.0001
91490027|NCT02319837|182852569|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.423||||0.0057|TWO_SIDED|95.0|0.226|0.794|||Log Rank|||||0.794|0.226|0.0057
91528069|NCT00358215|182931382|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.79||0.005|TWO_SIDED|95.0|0.65|3.75|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||3.75|0.65|0.005
91694896|NCT04015518|183284664|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0771||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0771
91694897|NCT04015518|183284665|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|-0.005|0.427|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.427|-0.005|
91694898|NCT04015518|183284665|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.032|0.401|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.401|-0.032|
91694899|NCT04015518|183284665|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.248|||||TWO_SIDED|95.0|0.032|0.471|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.471|0.032|
91724701|NCT04764539|183343787|SUPERIORITY||Mean Difference (Final Values)|0.5383|STANDARD_DEVIATION|0.659|<|0.2128|TWO_SIDED|95.0|-0.471|1.548||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.548|-0.471|<0.2128
91724702|NCT04764539|183343787|SUPERIORITY||Mean Difference (Final Values)|0.298|STANDARD_DEVIATION|0.365|<|0.533|TWO_SIDED|95.0|-0.915|1.511||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.511|-0.915|<0.533
91724703|NCT04764539|183343788|SUPERIORITY||Mean Difference (Final Values)|1.388|STANDARD_DEVIATION|1.7|<|0.289|TWO_SIDED|95.0|-1.763|4.539||Sample size too small for statistical power. In addition, automated speech recognition for child speech had a very poor state-of-the-art at the time of this study.|ANOVA||Difference = (iPad Pro group - VR goggles group)|The percentage of correctly transcribed words using automatic speech recognition will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||4.539|-1.763|<0.289
91490028|NCT02319837|182852570|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.078||||0.4321|TWO_SIDED|95.0|0.894|1.301|||Log Rank|||||1.301|0.894|0.4321
91724704|NCT04764539|183343789|SUPERIORITY||Mean Difference (Final Values)|-3.51|STANDARD_DEVIATION|4.3||0.4296|TWO_SIDED|95.0|-49.68|42.66||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|Articulation Accuracy does not statistically differ for the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||42.66|-49.68|0.4296
91724705|NCT04764539|183343789|SUPERIORITY||Mean Difference (Final Values)|19.75|STANDARD_DEVIATION|24.19|<|0.294|TWO_SIDED|95.0|-25.7|65.2||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||65.2|-25.7|<0.294
91490029|NCT02319837|182852570|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.09||||0.3702|TWO_SIDED|95.0|0.904|1.314|||Log Rank|||||1.314|0.904|0.3702
91528070|NCT00358215|182931383|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|0.9||0.011|TWO_SIDED|95.0|0.53|4.05|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||4.05|0.53|0.011
91724706|NCT04764539|183343789|SUPERIORITY||Mean Difference (Final Values)|16.25|STANDARD_DEVIATION|19.9|<|0.419|TWO_SIDED|95.0|-33.86|66.36||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||66.36|-33.86|<0.419
91490030|NCT02319837|182852571|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.138||||0.1567|TWO_SIDED|95.0|0.954|1.357|||Log Rank|||||1.357|0.954|0.1567
91528071|NCT00871351|182931384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-5.8|||Hochberg's method|||||-5.8|-15.4|<0.0001
91528072|NCT00871351|182931384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-26.5|||<|0.0001|TWO_SIDED|95.0|-31.8|-21.2|||Hochberg's method|||||-21.2|-31.8|<0.0001
91528073|NCT00871351|182931385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Hochberg's method|||||||0.0003
91528074|NCT00871351|182931385|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Hochberg's method|||||||<0.0001
91528075|NCT02291289|182931418|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.872|TWO_SIDED|95.0|0.5|1.82|||Log Rank|||||1.82|0.50|= 0.872
91528076|NCT02291289|182931418|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.666|TWO_SIDED|95.0|0.77|1.18|||Log Rank|||||1.18|0.77|= 0.666
91724707|NCT04764539|183343790|SUPERIORITY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.63|<|0.659|TWO_SIDED|95.0|-6.436|9.096||Sample size to small for statistical power.|ANOVA||difference = (iPad group mean - VR goggles group mean)|||9.096|-6.436|<0.659
91724708|NCT04764539|183343791|SUPERIORITY||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|9.67|<|0.789|TWO_SIDED|95.0|-68.91|84.7|||ANOVA|Sample size too small for statistical power.|Difference = (iPad Pro group - VR Goggles group)|||84.7|-68.91|<0.789
91724709|NCT04764539|183343791|SUPERIORITY||Mean Difference (Final Values)|30.16|STANDARD_DEVIATION|36.94|<|0.304|TWO_SIDED|95.0|-40.85|101.17||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||101.17|-40.85|<0.304
91724710|NCT04764539|183343791|SUPERIORITY||Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|27.26|<|0.403|TWO_SIDED|95.0|-43.91|88.43||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||88.43|-43.91|<0.403
91724711|NCT04764539|183343792|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_DEVIATION|2.87|<|0.485|TWO_SIDED|95.0|-10.79|6.11||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The response to treatment stimuli will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||6.11|-10.79|<0.485
91724712|NCT04764539|183343792|SUPERIORITY||Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|6.94|<|0.065|TWO_SIDED|95.0|-0.569|11.9||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||11.9|-0.569|<0.065
91724713|NCT04764539|183343792|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_DEVIATION|4.09|<|0.549|TWO_SIDED|95.0|-10.85|17.53||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||17.53|-10.85|<0.549
91724714|NCT01137812|183343812|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.|Least-Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.064|<|0.05|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus sitagliptin\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.||-0.250|-0.500|<0.05
91724715|NCT01137812|183343813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.3|2.48|||Regression, Logistic|||||2.48|1.30|
91724716|NCT01137812|183343814|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.89|-18.24|||ANCOVA|||||-18.24|-29.89|<0.001
91724717|NCT01137812|183343815|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.3|-2.2|||ANCOVA|||||-2.2|-3.3|<0.001
91490031|NCT02319837|182852571|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.168||||0.0855|TWO_SIDED|95.0|0.981|1.391|||Log Rank|||||1.391|0.981|0.0855
91724718|NCT01137812|183343816|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|0.883|<|0.001|TWO_SIDED|95.0|-7.642|-4.175|||ANCOVA|||||-4.175|-7.642|<0.001
91724719|NCT01137812|183343817|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.9||0.554|TWO_SIDED|95.0|-9.8|5.3|||ANCOVA|||||5.3|-9.8|0.554
91724720|NCT01137812|183343818|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|4.6|9.3|||ANCOVA|||||9.3|4.6|<0.001
91724721|NCT02265744|183343827|SUPERIORITY|||||||0.9745|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9745
91490032|NCT01961362|182852661|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_DEVIATION|0.87||0.6|TWO_SIDED|||||P\<0.05 considered to represent statistical significance.|t-test, 2 sided|||||||0.6
91724722|NCT02265744|183343827|SUPERIORITY|||||||0.6217|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.6217
91724723|NCT02265744|183343827|SUPERIORITY|||||||0.8295|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.8295
91724724|NCT02265744|183343827|SUPERIORITY|||||||0.9439|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9439
91490033|NCT01961362|182852661|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91724725|NCT00923702|183343861|NON_INFERIORITY|To test for non-inferiority of antibody concentrations in different dose groups, log-transformed mean MFIs in linear regression models were used to obtain MFI ratios and their corresponding 95% confidence intervals (CIs). Antibody titres at months 0, 7, 12, 36 and 48 were compared and non-inferiority was inferred when the lower bound of the confidence interval of the ratio of the immunogenicity measures exceeded 0.5.|Risk Ratio (RR)|0.5|||||ONE_SIDED||||||Regression, Linear||The lower bound of the 95% CI ratio of immunogeneicity measures was used instead. No p-values were estimated.|||||
91724726|NCT00923702|183343862|SUPERIORITY||Vaccine efficacy|95.0|||||TWO_SIDED|||||||||||||
91724727|NCT01086475|183343866|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
91724728|NCT01086475|183343867|SUPERIORITY_OR_OTHER|||||||0.927|||||||Chi-squared|||||||0.927
91724729|NCT01086475|183343868|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||t-test, 2 sided|||||||0.048
91724730|NCT02448043|183343902|SUPERIORITY|||||||0.532||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.532
91724731|NCT02448043|183343903|SUPERIORITY|||||||0.523||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.523
91724732|NCT02448043|183343904|SUPERIORITY|||||||0.912||||||Threshold is p\<0.05|t-test, 2 sided|||Comparing baseline values of both arms to completion values of both arms||||0.912
91528077|NCT02291289|182931418|SUPERIORITY||Hazard Ratio (HR)|1.44|||=|0.128|TWO_SIDED|95.0|0.9|2.29|||Log Rank|||||2.29|0.90|= 0.128
91694900|NCT04015518|183284665|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|0.024|0.367|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.367|0.024|
91694901|NCT04015518|183284665|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0158||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0158
91694902|NCT04015518|183284665|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.012||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0120
91694903|NCT04015518|183284665|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0429||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0429
91724733|NCT02448043|183343905|SUPERIORITY|||||||0.062||||||Threshold is p\<0.05|t-test, 2 sided|||Comparison between baseline nail brittleness values and completion values||||0.062
91724734|NCT02337946|183343984|SUPERIORITY||Difference of PFS rate between groups|0.9|||||TWO_SIDED|95.0|-17.2|19.0|||||||Agresti-Caffo method was used for estimation of 95% CI.|19.0|-17.2|
91528078|NCT02291289|182931419|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.276|TWO_SIDED|95.0|0.39|1.32|||Log Rank|||||1.32|0.39|= 0.276
91528079|NCT02291289|182931419|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.076|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||||1.02|0.64|= 0.076
91528080|NCT02291289|182931419|SUPERIORITY||||||=|0.157|||||||Log Rank|||||||= 0.157
91528081|NCT02291289|182931419|SUPERIORITY||Hazard Ratio (HR)|1.25|||=|0.415|TWO_SIDED|95.0|0.73|2.14|||Log Rank|||||2.14|0.73|= 0.415
91528082|NCT02291289|182931421|SUPERIORITY||||||=|0.064|||||||Chi-squared|||||||= 0.064
91528083|NCT02291289|182931421|SUPERIORITY||||||=|0.658|||||||Chi-squared|||||||= 0.658
91528084|NCT02291289|182931421|SUPERIORITY|||||||0.093|||||||Chi-squared|||||||0.093
91528085|NCT02291289|182931422|SUPERIORITY||||||=|0.125|||||||Chi-squared|||||||= 0.125
91528086|NCT02291289|182931422|SUPERIORITY||||||=|0.739|||||||Chi-squared|||||||= 0.739
91528087|NCT02291289|182931422|SUPERIORITY|||||||0.362|||||||Chi-squared|||||||0.362
91694904|NCT04015518|183284665|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0229||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0229
91694905|NCT04015518|183284665|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.03||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0300
91694906|NCT04015518|183284666|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-18.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.2|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-37.2|
91694907|NCT04015518|183284666|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-19.3|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-38.3|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-38.3|
91694908|NCT04015518|183284666|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-26.6|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-45.5|-7.8|||||Difference was calculated as Speso - placebo.|||-7.8|-45.5|
91694909|NCT04015518|183284666|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|7.9|||TWO_SIDED|95.0|-21.1|10.2|||||Difference was calculated as Speso - placebo.|||10.2|-21.1|
91694910|NCT02046005|183284667|SUPERIORITY||Risk Ratio (RR)|1.23||||0.043|TWO_SIDED|95.0|1.01|1.51||We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).|generalized estimating equations||PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)|"In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)"||1.51|1.01|0.043
91694911|NCT00468481|183284772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|384.7|||<|0.0001||95.0|282.42|486.98|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate|Difference = DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.||486.98|282.42|<0.0001
91694912|NCT00468481|183284773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87|||<|0.0001||95.0|14.04|23.7|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate|Difference =DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.||23.70|14.04|<0.0001
91694913|NCT01068730|183284852|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|102.58|||||TWO_SIDED|95.0|99.07|106.23|||||Ratio=Treatment B/Treatment A. Geometric least squares (LS) means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.23|99.07|
91528088|NCT02291289|182931424|SUPERIORITY||||||=|0.421|||||||Log Rank|||||||= 0.421
91724735|NCT02337946|183343985|SUPERIORITY||Adjusted Hazard Ratio (HR)|0.93||||0.7349|TWO_SIDED|95.0|0.6|1.43|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.43|0.60|0.7349
91724736|NCT02337946|183343986|SUPERIORITY||Adjusted Hazard Ratio (HR)|1.41||||0.3485|TWO_SIDED|95.0|0.69|2.88|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||2.88|0.69|0.3485
91724737|NCT02337946|183343988|SUPERIORITY||Multivariable Hazard Ratio (HR)|0.9||||0.5901|TWO_SIDED|95.0|0.6|1.33|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.33|0.60|0.5901
91724738|NCT02949934|183343994|SUPERIORITY|||||||0.013|||||||ANCOVA|Covariates were age, baseline AUDIT score, baseline drinks per day, and whether participant participated before vs. during the COVID-19 pandemic.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group.||||0.013
91724739|NCT02949934|183343995|SUPERIORITY|||||||0.014|||||||ANCOVA|Covariates were age, baseline AUDIT score, and baseline drinks per day.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group||||0.014
91724740|NCT02949934|183343996|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.062
91724741|NCT02949934|183343997|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.83
91724742|NCT02949934|183343997|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|Linear mixed model testing interaction between medication group and time, controlling for scanner||||||0.026
91724743|NCT03971422|183344049|SUPERIORITY||LS Mean Difference|-2.586|||<|0.001|TWO_SIDED|95.0|-4.091|-1.249||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||Mixed model repeated measure (MMRM) ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.249|-4.091|<0.001
91724744|NCT03971422|183344049|SUPERIORITY||LS Mean Difference|-2.619|||<|0.001|TWO_SIDED|95.0|-3.994|-1.163||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM analysis of covariance (ANCOVA) model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.163|-3.994|<0.001
91724745|NCT03971422|183344050|SUPERIORITY||Odds Ratio (OR)|5.765|||<|0.001|TWO_SIDED|95.0|2.1|14.882||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||14.882|2.100|<0.001
91724746|NCT03971422|183344050|SUPERIORITY||Odds Ratio (OR)|4.273|||<|0.001|TWO_SIDED|95.0|1.653|11.791||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||11.791|1.653|<0.001
91724747|NCT03971422|183344051|SUPERIORITY||LS Mean Difference|-3.901|||<|0.001|TWO_SIDED|95.0|-6.634|-1.245||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.245|-6.634|<0.001
91724748|NCT03971422|183344051|SUPERIORITY||LS Mean Difference|-5.525|||<|0.001|TWO_SIDED|95.0|-8.303|-2.968||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.968|-8.303|<0.001
91724749|NCT03971422|183344052|SUPERIORITY||LS Mean Difference|-3.483|||<|0.001|TWO_SIDED|95.0|-5.614|-1.584||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.584|-5.614|<0.001
91724750|NCT03971422|183344052|SUPERIORITY||LS Mean Difference|-4.756|||<|0.001|TWO_SIDED|95.0|-6.821|-2.859||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.859|-6.821|<0.001
91528089|NCT02291289|182931424|SUPERIORITY||||||=|0.495|||||||Log Rank|||||||= 0.495
91694914|NCT01068730|183284852|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|99.67|||||TWO_SIDED|95.0|96.16|103.31|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.31|96.16|
91694915|NCT01068730|183284852|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7062.8||||||||||||||Geometric least squares means for Treatment A||||
91694916|NCT01068730|183284852|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7245.2||||||||||||||Geometric least squares means for Treatment B||||
91694917|NCT01068730|183284852|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11680.0||||||||||||||Geometric least squares means for Treatment C||||
91694918|NCT01068730|183284852|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)]|11641.0||||||95.0||||||||Geometric least squares means for Treatment D||||
91694919|NCT01068730|183284853|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|101.12|||||TWO_SIDED|95.0|96.36|106.11|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.11|96.36|
91694920|NCT01068730|183284853|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|98.65|||||TWO_SIDED|95.0|93.94|103.59|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.59|93.94|
91694921|NCT01068730|183284853|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1013.6||||||||||||||Geometric least squares means for Treatment A||||
91694922|NCT01068730|183284853|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1024.9||||||||||||||Geometric least squares means for Treatment B||||
91694923|NCT01068730|183284853|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1643.8||||||||||||||Geometric least squares means for Treatment C||||
91694924|NCT01068730|183284853|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1621.6||||||||||||||Geometric least squares means for Treatment D||||
91694925|NCT01068730|183284863|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|103.19|||||TWO_SIDED|95.0|99.75|106.75|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|||106.75|99.75|
91694926|NCT01068730|183284863|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.44|||||TWO_SIDED|95.0|96.08|102.92|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|||102.92|96.08|
91694927|NCT01068730|183284863|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|6907.1||||||||||||||Geometric least squares means for Treatment A||||
91694928|NCT01068730|183284863|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7127.4||||||95.0||||||||Geometric least squares means for Treatment B||||
91694929|NCT01068730|183284863|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11391.0||||||||||||||Geometric least squares means for Treatment C||||
91694930|NCT01068730|183284863|SUPERIORITY_OR_OTHER||[Geometric Least Squares Mean (ng*hr/mL)|11327.0||||||||||||||Geometric least squares means for Treatment D||||
91694931|NCT02498444|183284883|OTHER||Risk Ratio (RR)|1.29||||0.03|TWO_SIDED|95.0|1.02|1.64|||Poisson regression|Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)||||1.64|1.02|0.03
91694932|NCT02498444|183284884|OTHER||Risk Ratio (RR)|1.23||||0.0498|TWO_SIDED|95.0|1.0|1.51||Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)|Poisson regression|||||1.51|1.00|0.0498
91694933|NCT02498444|183284885|OTHER|||||||0.05|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.05
91694934|NCT02498444|183284885|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
91724751|NCT03971422|183344053|SUPERIORITY||LS Mean Difference|-12.441|||<|0.001|TWO_SIDED|95.0|-21.804|-4.089||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.089|-21.804|<0.001
91724752|NCT03971422|183344053|SUPERIORITY||LS Mean Difference|-15.163|||<|0.001|TWO_SIDED|95.0|-23.596|-6.45||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-6.450|-23.596|<0.001
91724753|NCT03971422|183344054|SUPERIORITY||LS Mean Difference|-8.65||||0.012|TWO_SIDED|95.0|-18.058|-0.134||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-0.134|-18.058|0.012
91724754|NCT03971422|183344054|SUPERIORITY||LS Mean Difference|-14.822|||<|0.001|TWO_SIDED|95.0|-23.759|-5.936||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-5.936|-23.759|<0.001
91724755|NCT03971422|183344055|SUPERIORITY||LS Mean Difference|-11.32|||<|0.001|TWO_SIDED|95.0|-18.958|-4.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.998|-18.958|<0.001
91724756|NCT03971422|183344055|SUPERIORITY||LS Mean Difference|-10.705|||<|0.001|TWO_SIDED|95.0|-17.787|-3.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-3.998|-17.787|<0.001
91724757|NCT03083379|183344085|EQUIVALENCE|Equivalency is defined as no statistically significant difference in dorsal region redistribution of ventilation following breath cycle 1, 2, and 3 lung expansion therapy sequences.||||||0.9|||||||Mann-Whitney U test|||||||.90
91724758|NCT00327171|183344090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.5043|TWO_SIDED|95.0|0.8|1.58|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor|||1.58|0.80|0.5043
91724759|NCT00327171|183344093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.5592|TWO_SIDED|95.0|0.81|1.48|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4mg/kg vs. 2mg/kg)|||1.48|0.81|0.5592
91724760|NCT00327171|183344094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.124||||0.5457|TWO_SIDED|95.0|0.77|1.64|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4 mg/kg vs. 2mg/kg)|||1.64|0.77|0.5457
91724761|NCT01363440|183344098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.19|||<|0.0001|TWO_SIDED|97.5|9.35|15.04|||ANCOVA|||||15.04|9.35|<.0001
91724762|NCT01363440|183344098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.45|||<|0.0001|TWO_SIDED|97.5|7.73|13.17|||ANCOVA|||||13.17|7.73|<.0001
91724763|NCT01363440|183344099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.9||||0.0001|TWO_SIDED|97.5|34.7|57.0|||Cochran-Mantel-Haenszel|||||57.0|34.7|.0001
91724764|NCT01363440|183344099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.8||||0.0001|TWO_SIDED|97.5|27.2|50.3|||Cochran-Mantel-Haenszel|||||50.3|27.2|.0001
91724765|NCT01363440|183344100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.2|||<|0.0001|TWO_SIDED|97.5|24.1|44.4|||Cochran-Mantel-Haenszel|||||44.4|24.1|<0.0001
91724766|NCT01363440|183344100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.3|||<|0.0001|TWO_SIDED|97.5|13.5|33.1|||Cochran-Mantel-Haenszel|||||33.1|13.5|<.0001
91724767|NCT01363440|183344101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7|||<|0.0001|TWO_SIDED|97.5|9.0|30.4|||Cochran-Mantel-Haenszel|||||30.4|9.0|<.0001
91724768|NCT01363440|183344101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.9||||0.0017|TWO_SIDED|97.5|4.4|25.4|||Cochran-Mantel-Haenszel|||||25.4|4.4|0.0017
91724769|NCT01363440|183344102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-110.8|||<|0.0001|TWO_SIDED|97.5|-141.3|-80.22|||ANCOVA|||||-80.22|-141.3|<.0001
91724770|NCT01363440|183344102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-113.5|||<|0.0001|TWO_SIDED|97.5|-144.2|-82.75|||ANCOVA|||||-82.75|-144.2|<.0001
91528090|NCT02291289|182931424|SUPERIORITY|||||||0.357|||||||Log Rank|||||||0.357
91724771|NCT01363440|183344103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.19||||0.0168||97.5|0.33|10.04|||ANCOVA|||||10.04|0.33|0.0168
91724772|NCT01363440|183344103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.36||||0.0323|TWO_SIDED|97.5|-0.21|8.93|||ANCOVA|||||8.93|-0.21|0.0323
91724773|NCT01363440|183344104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.86||||0.1702|TWO_SIDED|97.5|-1.82|7.54|||ANCOVA|||||7.54|-1.82|0.1702
91724774|NCT01363440|183344104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.4067|TWO_SIDED|97.5|-2.83|6.13|||ANCOVA|||||6.13|-2.83|0.4067
91724775|NCT03695094|183344114|OTHER||Geometric mean ratio|0.725|||||TWO_SIDED|90.0|0.586|0.896|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.896|0.586|
91724776|NCT03695094|183344116|OTHER||Geometric mean ratio|0.636|||||TWO_SIDED|90.0|0.504|0.801|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.801|0.504|
91724777|NCT01795937|183344135|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|198.55|STANDARD_DEVIATION|14.2|||TWO_SIDED|90.0|182.43|216.09|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir||216.09|182.43|
91724778|NCT01795937|183344136|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|180.63|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|165.68|196.93|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir.||196.93|165.68|
91724779|NCT01795937|183344137|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|946.45|STANDARD_DEVIATION|27.3|||TWO_SIDED|90.0|797.61|1123.07|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1123.07|797.61|
91724780|NCT01795937|183344138|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3372.72|STANDARD_DEVIATION|20.5|||TWO_SIDED|90.0|2961.95|3840.47|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||3840.47|2961.95|
91724781|NCT01795937|183344141|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1358.91|STANDARD_DEVIATION|16.4|||TWO_SIDED|90.0|1224.32|1508.29|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1508.29|1224.32|
91724782|NCT01795937|183344142|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1466.35|STANDARD_DEVIATION|23.3|||TWO_SIDED|90.0|1277.62|1682.95|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1682.95|1277.62|
91724783|NCT01795937|183344143|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3288.7|STANDARD_DEVIATION|28.5|||TWO_SIDED|90.0|2782.04|3887.63|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||3887.63|2782.04|
91724784|NCT01795937|183344144|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1678.23|STANDARD_DEVIATION|22.6|||TWO_SIDED|90.0|1468.52|1917.89|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1917.89|1468.52|
91724785|NCT03927157|183344150|SUPERIORITY||Rate Ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.17|0.39|||Negative Binomial Regression|||||0.39|0.17|<0.001
91724786|NCT03927157|183344151|SUPERIORITY||Least Squares Mean Difference|0.24|||<|0.001|TWO_SIDED|95.0|0.16|0.32|||Mixed Models Analysis|||||0.32|0.16|<0.001
91724787|NCT03927157|183344152|SUPERIORITY||Least Squares Means Difference|0.35||||0.001|TWO_SIDED|95.0|0.14|0.55|||Mixed Models Analysis|||||0.55|0.14|0.001
91724788|NCT03927157|183344153|SUPERIORITY||Least Squares Means Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<0.001
91724789|NCT03927157|183344154|SUPERIORITY||Least Squares Means Difference|-0.16||||0.001|TWO_SIDED|95.0|-0.27|-0.06|||Mixed Models Analysis|||||-0.06|-0.27|0.001
91724790|NCT00303628|183344213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876|TWO_SIDED|||||Stratified log rank test. The above P value was for one-sided test|Log Rank|||||||0.876
91724791|NCT00303628|183344214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED|||||two-sided stratified log rank test p value|Log Rank|||||||0.299
91490034|NCT01961362|182852662|SUPERIORITY||Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91490035|NCT01761175|182852706|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
91490036|NCT01761175|182852707|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
91490037|NCT01761175|182852708|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
91490038|NCT01761175|182852709|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
91490039|NCT01761175|182852710|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
91490040|NCT01761175|182852711|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91490041|NCT01761175|182852712|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
91490042|NCT00467857|182852765|SUPERIORITY_OR_OTHER|||||||0.655||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.655
91490043|NCT00467857|182852766|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Wilcoxon-Rank Sum Test|||||||0.276
91528091|NCT01017120|182931426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
91528092|NCT01017120|182931426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
91694935|NCT02498444|183284885|OTHER|||||||0.14|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.14
91694936|NCT02498444|183284886|OTHER|||||||0.23|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.23
91694937|NCT02498444|183284886|OTHER|||||||0.27|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||0.27
91694938|NCT02498444|183284886|OTHER|||||||0.65|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.65
91694939|NCT02498444|183284887|OTHER|||||||0.37|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.37
91694940|NCT02498444|183284887|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
91694941|NCT02498444|183284887|OTHER|||||||0.3|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.30
91694942|NCT01073605|183284931|SUPERIORITY_OR_OTHER|||||||0.02922|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.02922
91694943|NCT01073605|183284931|SUPERIORITY_OR_OTHER|||||||0.74299|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.74299
91694944|NCT01073605|183284931|SUPERIORITY_OR_OTHER|||||||0.00467|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.00467
91490044|NCT00467857|182852767|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Wilcoxon-Rank Sum Test|||||||0.375
91490045|NCT00467857|182852768|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon-Rank Sum Test|||||||0.039
91490046|NCT00467857|182852769|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Wilcoxon-Rank Sum Test|||||||0.057
91490047|NCT00467857|182852770|SUPERIORITY_OR_OTHER|||||||0.646||95.0|||||Wilcoxon-Rank Sum Test|||||||0.646
91490048|NCT00467857|182852771|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon-Rank Sum Test|||||||0.788
91490049|NCT00467857|182852772|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon-Rank Sum Test|||||||0.960
91490050|NCT00467857|182852773|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.359
91490051|NCT00467857|182852774|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon-Rank Sum Test|||||||0.730
91490052|NCT00467857|182852775|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Wilcoxon-Rank Sum Test|||||||0.348
91490053|NCT00467857|182852776|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||Wilcoxon-Rank Sum Test|||||||0.512
91490054|NCT00467857|182852777|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Chi-squared|||||||0.285
91490055|NCT00467857|182852778|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
91528093|NCT01017120|182931426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
91528094|NCT01017120|182931427|SUPERIORITY_OR_OTHER||Percentage of participants|32.2|||<|0.001|TWO_SIDED|95.0|27.4|36.9|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||36.9|27.4|<0.001
91694945|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.00125|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00125
91694946|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.25995|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.25995
91694947|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||8e-05|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00008
91694948|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.03273|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.03273
91694949|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.68581|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.68581
91724792|NCT03158688|183344219|SUPERIORITY||Stratified Cox model hazard ratio|0.63||||0.0014|TWO_SIDED|95.0|0.464|0.854||alpha level of 0.025|Log Rank||KdD/Kd|Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \>= 2).||0.854|0.464|0.0014
91724793|NCT03158688|183344220|SUPERIORITY||Odds Ratio (OR)|1.925||||0.004|TWO_SIDED|95.0|1.184|3.129|||Cochran-Mantel-Haenszel||KdD/Kd|"Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.~P-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test."||3.129|1.184|0.0040
91724794|NCT03158688|183344221|SUPERIORITY||Odds Ratio (OR)|7.819|||||TWO_SIDED|95.0|2.364|25.858|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.||25.858|2.364|
91724795|NCT03158688|183344222|SUPERIORITY||Cox Proportional Hazard|0.784||||0.0417|TWO_SIDED|95.0|0.595|1.033|||Log Rank||KdD/Kd|"Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.~1-sided p-value from the log-rank test controlling for the randomization stratification factors."||1.033|0.595|0.0417
91724796|NCT03158688|183344231|SUPERIORITY||Odds Ratio (OR)|4.403|||||TWO_SIDED|95.0|2.007|9.656|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated by a stratified analysis using the Mantel-Haenszel method.||9.656|2.007|
91694950|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.00530
91694951|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.57556|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.57556
91694952|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.63956|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.63956
91694953|NCT01073605|183284933|SUPERIORITY_OR_OTHER|||||||0.16421|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.16421
91694954|NCT01073605|183284937|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.0001
91694955|NCT01073605|183284937|SUPERIORITY_OR_OTHER|||||||0.58324|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.58324
91694956|NCT01073605|183284937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||<0.0001
91694957|NCT01073605|183284942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.0681|TWO_SIDED|95.0|-0.05|1.39||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||1.39|-0.05|0.0681
91724797|NCT03158688|183344232|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.24||0.948|TWO_SIDED|95.0|-2.52|2.35|||linear mixed effects model||The overall treatment difference (KdD - Kd)|Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.||2.35|-2.52|0.9480
91724798|NCT02942407|183344233|NON_INFERIORITY|Due to a lower recruitment rate than anticipated in the early stage of the trial, the sample size was curtailed from 760 to 230 patients. Thus, under the initial protocol assumptions, the study is considered under-powered for the two-sided upper 95% CI on the HR to rule-out the non-inferiority margin of 1.40.|Hazard Ratio (HR)|1.2||||0.321|TWO_SIDED|95.0|0.63|2.3|||Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin)|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|Exploratory analysis due to failure to reach initial sample size: Non-inferiority (NI) null hypothesis: HR \>= 1.4 (Non-inferiority).||2.3|0.63|0.321
91724799|NCT02942407|183344233|SUPERIORITY|Exploratory analysis due to lack of achieving initial sample size.|Hazard Ratio (HR)|1.2||||0.583|TWO_SIDED|95.0|0.63|2.3||If upper limit of 95% confidence interval \< 1 this would be considered evidence of superiority.|Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin).|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|||2.3|0.63|0.583
91694958|NCT01073605|183284942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.8971|TWO_SIDED|95.0|-0.65|0.74||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.74|-0.65|0.8971
91694959|NCT01073605|183284942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0583|TWO_SIDED|95.0|-1.27|0.02||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.02|-1.27|0.0583
91694960|NCT03491462|183284944|SUPERIORITY|||||||0.6208|||||||Gehan's extended Wilcoxon's test|||||||0.6208
91694961|NCT00402688|183284978|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.063||||||95.0|-0.089|0.215|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).|||0.215|-0.089|
91724800|NCT02942407|183344235|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.74|2.93||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of study date (July 27, 2019).||2.93|0.74|
91724801|NCT02942407|183344244|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.67|2.17||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of stud date (July 27, 2019).||2.17|0.67|
91724802|NCT05887908|183344246|NON_INFERIORITY|Non-inferirority margin = 15.0%|Difference in success proportion|21.3|||||TWO_SIDED|95.0|10.9|32.0||If the lower limit of the 2-sided 95% CI of the group difference \> -15.0%, non-inferiority is concluded. If non-inferiority is declared, a test for superiority will be performed. If the lower bound of the 95% CI \> 0.0%, superiority will be declared.|||Miettinen-Nurminen confidence interval|||32.0|10.9|
91724803|NCT05887908|183344246|NON_INFERIORITY|Non-inferirority margin = 15.0%|Difference in success proportion|11.4|||||TWO_SIDED|95.0|-1.2|23.7||If non-inferiority of the cefepime/nacubactam group is declared, a non-inferiority hypothesis test for the aztreonam/nacubactam group will be performed. For this analysis, the same approach as that used for the cefepime/nacubactam group will be used.|||Miettinen-Nurminen confidence interval|||23.7|-1.2|
91724804|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|2.5|||||TWO_SIDED|95.0|-3.2|9.9|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EA||9.9|-3.2|
91724805|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|6.8|||||TWO_SIDED|95.0|1.1|14.0|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EA||14.0|1.1|
91724806|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|3.5|||||TWO_SIDED|95.0|-2.7|11.3|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EOT||11.3|-2.7|
91724807|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|1.5|||||TWO_SIDED|95.0|-6.6|10.0|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EOT||10.0|-6.6|
91724808|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|6.8|||||TWO_SIDED|95.0|-4.1|18.1|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at FUP||18.1|-4.1|
91724809|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|3.3|||||TWO_SIDED|95.0|-9.5|16.0|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at FUP||16.0|-9.5|
91724810|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|24.1|||||TWO_SIDED|95.0|12.0|36.6|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli||36.6|12.0|
91724811|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|10.5|||||TWO_SIDED|95.0|-4.2|24.9|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli||24.9|-4.2|
91724812|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|28.1|||||TWO_SIDED|95.0|1.8|54.1|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae||54.1|1.8|
91724813|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|35.4|||||TWO_SIDED|95.0|1.1|61.6|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae||61.6|1.1|
91724814|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|6.4|||||TWO_SIDED|95.0|-1.3|16.3|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli||16.3|-1.3|
91724815|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|4.2|||||TWO_SIDED|95.0|-5.6|14.7|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli||14.7|-5.6|
91724816|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|-6.3|||||TWO_SIDED|95.0|-20.3|13.9|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae||13.9|-20.3|
91724817|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|-16.7|||||TWO_SIDED|95.0|-45.4|5.2|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae||5.2|-45.4|
91724818|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|11.2|||||TWO_SIDED|95.0|-1.7|24.4|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli||24.4|-1.7|
91724819|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|6.2|||||TWO_SIDED|95.0|-8.7|20.9|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli||20.9|-8.7|
91724820|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|-6.3|||||TWO_SIDED|95.0|-31.9|23.1|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae||23.1|-31.9|
91724821|NCT05887908|183344247|OTHER|Descriptive analysis|Difference in success proportion|6.3|||||TWO_SIDED|95.0|-28.8|37.9|||||Miettinen-Nurminen confidence interval|Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae||37.9|-28.8|
91724822|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|2.3|||||TWO_SIDED|95.0|-2.8|6.3|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EA||6.3|-2.8|
91724823|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|1.7|||||TWO_SIDED|95.0|-3.5|7.2|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EA||7.2|-3.5|
91724824|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|0.1|||||TWO_SIDED|95.0|-4.6|6.4|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EOT||6.4|-4.6|
91724825|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|-0.6|||||TWO_SIDED|95.0|-7.1|6.0|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EOT||6.0|-7.1|
91724826|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|3.5|||||TWO_SIDED|95.0|-3.3|11.8|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at TOC||11.8|-3.3|
91724827|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|4.3|||||TWO_SIDED|95.0|-3.9|13.0|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at TOC||13.0|-3.9|
91724828|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|3.1|||||TWO_SIDED|95.0|-4.5|12.1|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at FUP||12.1|-4.5|
91724829|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|2.7|||||TWO_SIDED|95.0|-6.6|12.3|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at FUP||12.3|-6.6|
91724830|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|1.8|||||TWO_SIDED|95.0|-4.2|6.0|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EA by baseline pathogen: Escherichia coli||6.0|-4.2|
91724831|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|2.1|||||TWO_SIDED|95.0|-4.1|8.3|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EA by baseline pathogen: Escherichia coli||8.3|-4.1|
91724832|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|6.3|||||TWO_SIDED|95.0|-13.9|20.3|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae||20.3|-13.9|
91724833|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|8.3|||||TWO_SIDED|95.0|-12.6|36.0|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae||36.0|-12.6|
91528095|NCT01017120|182931427|SUPERIORITY_OR_OTHER||Percentage of participants|18.2|||||TWO_SIDED|95.0|14.2|22.1|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||22.1|14.2|
91724834|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|2.3|||||TWO_SIDED|95.0|-3.5|10.5|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli||10.5|-3.5|
91724835|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|1.0|||||TWO_SIDED|95.0|-6.9|9.6|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli||9.6|-6.9|
91724836|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|-3.1|||||TWO_SIDED|95.0|-15.9|16.8|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae||16.8|-15.9|
91724837|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|-8.3|||||TWO_SIDED|95.0|-36.0|12.6|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae||12.6|-36.0|
91724838|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|3.2|||||TWO_SIDED|95.0|-4.5|13.1|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli||13.1|-4.5|
91724839|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|4.0|||||TWO_SIDED|95.0|-5.3|14.2|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli||14.2|-5.3|
91724840|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|12.5|||||TWO_SIDED|95.0|-6.0|38.0|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae||38.0|-6.0|
91724841|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|10.4|||||TWO_SIDED|95.0|-20.5|37.3|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae||37.3|-20.5|
91724842|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|6.7|||||TWO_SIDED|95.0|-2.6|17.8|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli||17.8|-2.6|
91724843|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|6.1|||||TWO_SIDED|95.0|-5.0|17.8|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli||17.8|-5.0|
91724844|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|-6.3|||||TWO_SIDED|95.0|-23.6|17.6|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae||17.6|-23.6|
91724845|NCT05887908|183344248|OTHER|Descriptive analysis|Difference in success proportion|-2.1|||||TWO_SIDED|95.0|-30.9|22.3|||||Miettinen-Nurminen confidence interval|Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae||22.3|-30.9|
91724846|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|3.4|||||TWO_SIDED|95.0|-1.7|10.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EA||10.5|-1.7|
91724847|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|7.6|||||TWO_SIDED|95.0|3.9|14.3|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EA||14.3|3.9|
91724848|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|4.4|||||TWO_SIDED|95.0|-1.3|11.9|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EOT||11.9|-1.3|
91724849|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|3.3|||||TWO_SIDED|95.0|-4.2|11.2|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EOT||11.2|-4.2|
91724850|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|22.2|||||TWO_SIDED|95.0|12.2|32.7|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at TOC||32.7|12.2|
91724851|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|10.3|||||TWO_SIDED|95.0|-2.0|22.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at TOC||22.5|-2.0|
91724852|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|8.6|||||TWO_SIDED|95.0|-2.0|19.7|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at FUP||19.7|-2.0|
91724853|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|2.2|||||TWO_SIDED|95.0|-10.4|14.8|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at FUP||14.8|-10.4|
91724854|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|2.3|||||TWO_SIDED|95.0|-3.5|10.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli||10.5|-3.5|
91724855|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|6.6|||||TWO_SIDED|95.0|2.3|14.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli||14.5|2.3|
91724856|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|12.5|||||TWO_SIDED|95.0|-6.0|38.0|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae||38.0|-6.0|
91724857|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|18.8|||||TWO_SIDED|95.0|-8.3|43.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae||43.5|-8.3|
91724858|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|6.9|||||TWO_SIDED|95.0|-0.1|16.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli||16.5|-0.1|
91724859|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|5.1|||||TWO_SIDED|95.0|-3.9|15.1|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli||15.1|-3.9|
91724860|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|-6.3|||||TWO_SIDED|95.0|-20.3|13.9|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae||13.9|-20.3|
91528096|NCT01017120|182931428|SUPERIORITY_OR_OTHER||Percentage of participants|27.6|||<|0.001|TWO_SIDED|95.0|23.1|32.2|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||32.2|23.1|<0.001
91724861|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|-8.3|||||TWO_SIDED|95.0|-36.0|12.6|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae||12.6|-36.0|
91724862|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|25.2|||||TWO_SIDED|95.0|13.5|37.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli||37.5|13.5|
91724863|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|8.9|||||TWO_SIDED|95.0|-5.5|23.3|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli||23.3|-5.5|
91724864|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|21.9|||||TWO_SIDED|95.0|-3.4|48.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae||48.5|-3.4|
91724865|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|29.2|||||TWO_SIDED|95.0|-4.4|56.0|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae||56.0|-4.4|
91724866|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|12.9|||||TWO_SIDED|95.0|0.3|25.9|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli||25.9|0.3|
91724867|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|4.6|||||TWO_SIDED|95.0|-10.1|19.3|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli||19.3|-10.1|
91724868|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|-6.3|||||TWO_SIDED|95.0|-30.4|22.6|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae||22.6|-30.4|
91724869|NCT05887908|183344249|OTHER|Descriptive analysis|Difference in success proportion|0.0|||||TWO_SIDED|95.0|-34.0|31.5|||||Miettinen-Nurminen confidence interval|Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae||31.5|-34.0|
91724870|NCT05887908|183344250|OTHER|Descriptive analysis|Difference in success proportion|20.0|||||TWO_SIDED|95.0|-16.0|54.3|||||Miettinen-Nurminen confidence interval|||54.3|-16.0|
91724871|NCT05887908|183344250|OTHER|Descriptive analysis|Difference in success proportion|28.9||||||95.0|-13.0|62.1|||||Miettinen-Nurminen confidence interval|||62.1|-13.0|
91724872|NCT05887908|183344251|OTHER|Descriptive analysis|Difference in success proportion|20.0|||||TWO_SIDED|95.0|-16.0|54.3|||||Miettinen-Nurminen confidence interval|||54.3|-16.0|
91724873|NCT05887908|183344251|OTHER|Descriptive analysis|Difference in success proportion|28.9||||||95.0|-13.0|62.1|||||Miettinen-Nurminen confidence interval|||62.1|-13.0|
91724874|NCT05887908|183344252|OTHER|Desriptive analysis|Difference in success proportion|53.3|||||TWO_SIDED|95.0|12.8|78.1|||||Miettinen-Nurminen confidence interval|||78.1|12.8|
91724875|NCT05887908|183344252|OTHER|Descriptive analysis|Difference in success proportion|24.4|||||TWO_SIDED|95.0|-18.4|60.5|||||Miettinen-Nurminen confidence interval|||60.5|-18.4|
91724876|NCT05887908|183344253|OTHER|Descriptive analysis|Difference in success proportion|20.0|||||TWO_SIDED|95.0|-16.0|54.3|||||Miettinen-Nurminen confidence interval|||54.3|-16.0|
91724877|NCT05887908|183344253|OTHER|Descriptive analysis|Difference in success proportion|28.9|||||TWO_SIDED|95.0|-13.0|62.1|||||Miettinen-Nurminen confidence interval|||62.1|-13.0|
91724878|NCT03928743|183344254|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.71|4.87|||Regression, Logistic|||||4.87|1.71|<0.001
91724879|NCT03928743|183344255|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|1.59|4.93|||Regression, Logistic|||||4.93|1.59|<0.001
91724880|NCT03928743|183344256|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Regression, Logistic|||||4.28|1.65|<0.001
91724881|NCT03928743|183344257|SUPERIORITY||LS Mean difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.48|-0.59|||Regression, Logistic|||||-0.59|-1.48|<0.001
91724882|NCT03928743|183344258|SUPERIORITY||Odds Ratio (OR)|4.26|||<|0.001|TWO_SIDED|95.0|1.93|9.39|||Regression, Logistic|||||9.39|1.93|<0.001
91724883|NCT03928743|183344259|SUPERIORITY||Odds Ratio (OR)|6.47|||<|0.001|TWO_SIDED|95.0|2.67|15.65|||Regression, Logistic|||||15.65|2.67|<0.001
91724884|NCT03928743|183344260|SUPERIORITY||Odds Ratio (OR)|4.65|||<|0.001|TWO_SIDED|4.65|2.51|7.57|||Regression, Logistic|||||7.57|2.51|<0.001
91724885|NCT03928743|183344261|SUPERIORITY||LS Mean difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.48|-0.63|||Regression, Logistic|||||-0.63|-1.48|<0.001
91724886|NCT03928743|183344262|SUPERIORITY||LS Mean difference|-1.48|||<|0.001|TWO_SIDED|95.0|-2.0|-0.96|||Regression, Logistic|||||-0.96|-2.00|<0.001
91724887|NCT03928743|183344263|SUPERIORITY||LS Mean difference|-1.52|||<|0.001|TWO_SIDED|95.0|-2.36|-0.68|||Regression, Logistic|||||-0.68|-2.36|<0.001
91724888|NCT03928743|183344264|SUPERIORITY||LS Mean difference|3.38|||<|0.001|TWO_SIDED|95.0|1.67|5.09|||Regression, Logistic|||||5.09|1.67|<0.001
91724889|NCT03928743|183344265|SUPERIORITY||LS Mean difference|-0.28||||0.006|TWO_SIDED|95.0|-0.47|-0.08|||Regression, Logistic|||||-0.08|-0.47|0.006
91490056|NCT03576495|182852787|SUPERIORITY|"We conducted a superiority statistical test to assess if residents' knowledge improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident knowledge, resident knowledge was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."|Mean Difference (Final Values)|2.6||||0.2422|TWO_SIDED|||||This p-value compares the average scores (in percent) of the residents' knowledge assessment at time period 2 between the Early Intervention and Delayed Intervention groups.|t-test, 2 sided|||||||0.2422
91724890|NCT03928743|183344266|SUPERIORITY||LS Mean difference|-1.08||||0.003|TWO_SIDED|95.0|-1.79|-0.38|||Regression, Logistic|||||-0.38|-1.79|0.003
91724891|NCT03928743|183344267|SUPERIORITY||Odds Ratio (OR)|2.47||||0.006|TWO_SIDED|95.0|1.3|4.68|||Regression, Logistic|||||4.68|1.30|0.006
91724892|NCT02762604|183344299|SUPERIORITY||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-19.36|15.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in normal pace gait speed pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||15.12|-19.36|
91724893|NCT02762604|183344299|SUPERIORITY||Mean Difference (Net)|17.19|STANDARD_ERROR_OF_MEAN|8.05|||TWO_SIDED|95.0|1.4|32.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait speed during walking while talking pre and post intervention||32.97|1.40|
91724894|NCT02762604|183344300|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|0.21|2.99|||||The estimate parameter reflects change in the number of correct letters generated pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|A linear mixed effects model was used to compare changes in correct letters generated pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.99|0.21|
91724895|NCT02762604|183344301|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|7.37|||TWO_SIDED|95.0|-12.04|16.85|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|Linear mixed effects model were used to compare changes in the functional activation/deactivation pattern (factor score) during imagery of walking-while talking (relative to walking and talking alone) pre and post intervention - as a function of of intervention (Imagined Gait vs. Visual Imagery)||16.85|-12.04|
91724896|NCT02762604|183344302|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|6.94|||TWO_SIDED|95.0|-14.15|13.07|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails a time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||13.07|-14.15|
91724897|NCT02762604|183344303|SUPERIORITY||Mean Difference (Net)|-12.21|STANDARD_ERROR_OF_MEAN|20.26|||TWO_SIDED|95.0|-51.92|27.51|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails b time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.51|-51.92|
91724898|NCT02762604|183344304|SUPERIORITY||Mean Difference (Net)|-10.83|STANDARD_ERROR_OF_MEAN|19.03|||TWO_SIDED|95.0|-48.12|26.47|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails B minus A time pre and post intervention.||26.47|-48.12|
91724899|NCT02762604|183344305|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.65|0.79|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in correct letter number sequences pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.79|-2.65|
91528097|NCT01017120|182931428|SUPERIORITY_OR_OTHER||Percentage of participants|13.3|||||TWO_SIDED|95.0|9.8|16.7|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||16.7|9.8|
91528098|NCT01118455|182931452|SUPERIORITY_OR_OTHER|||||||0.507|||||||Cochran-Mantel-Haenszel|||||||0.507
91724900|NCT02762604|183344306|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|12.95|||TWO_SIDED|95.0|-24.0|26.78|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in Stroop interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||26.78|-24.00|
91724901|NCT02762604|183344307|SUPERIORITY||Mean Difference (Net)|6.76|STANDARD_ERROR_OF_MEAN|79.95|||TWO_SIDED|95.0|-149.94|163.47|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in flanker interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||163.47|-149.94|
91724902|NCT02762604|183344308|SUPERIORITY||Mean Difference (Net)|15.2|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|5.99|24.41|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in stride length during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||24.41|5.99|
91724903|NCT02762604|183344309|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.73|-0.2|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait variability during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||-0.20|-3.73|
91724904|NCT02762604|183344311|SUPERIORITY||Mean Difference (Net)|2.43|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-5.98|10.84|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in total free recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||10.84|-5.98|
91724905|NCT02762604|183344312|SUPERIORITY||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-5.88|2.0|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed figure copy recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.00|-5.88|
91724906|NCT02762604|183344313|SUPERIORITY||Mean Difference (Net)|-6.36|STANDARD_ERROR_OF_MEAN|6.96|||TWO_SIDED|95.0|-20.01|7.28|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in word fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||7.28|-20.01|
91724907|NCT02762604|183344314|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|-6.51|17.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in semantic fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||17.97|-6.51|
91724908|NCT02762604|183344315|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-16.1|16.03||||||A linear mixed effects model was used to compare changes in digit symbol substitution performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)|The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|16.03|-16.10|
91724909|NCT02762604|183344317|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|7.54|||TWO_SIDED|95.0|-11.14|18.42|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in immediate maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||18.42|-11.14|
91724910|NCT02762604|183344318|SUPERIORITY||Mean Difference (Net)|3.26|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|95.0|-20.65|27.18|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.18|-20.65|
91724911|NCT02762604|183344319|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.45|0.9|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in maze errors pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.90|-0.45|
91724912|NCT02762604|183344320|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.74|2.26|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in depressive symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.26|-1.74|
91724913|NCT02762604|183344321|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-3.38|1.49|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in anxiety symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||1.49|-3.38|
91724914|NCT02762604|183344322|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.04|0.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in cortical thickness pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.12|-0.04|
91724915|NCT01405911|183344331|OTHER||Difference in Least Squares Means|-7.11|||<|0.001|TWO_SIDED|95.0|-9.85|-4.36|||Constrained Longitudinal Data Analysis|||||-4.36|-9.85|<0.001
91528099|NCT01118455|182931452|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Cochran-Mantel-Haenszel|||||||0.220
91528100|NCT01118455|182931452|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Cochran-Mantel-Haenszel|||||||0.168
91528101|NCT01118455|182931452|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Cochran-Mantel-Haenszel|||||||0.620
91724916|NCT01405911|183344331|OTHER||Difference in Least Squares Means|-9.08|||<|0.001|TWO_SIDED|95.0|-11.82|-6.33|||Constrained Longitudinal Data Analysis|||||-6.33|-11.82|<0.001
91724917|NCT01405911|183344331|OTHER||Difference in Least Squares Means|-1.97||||0.143|TWO_SIDED|95.0|-4.61|0.67|||Constrained Longitudinal Data Analysis|||||0.67|-4.61|0.143
91724918|NCT01405911|183344332|OTHER||Difference in Least Squares Means|-17.7|||<|0.001|TWO_SIDED|95.0|-21.55|-13.86|||Constrained Longitudinal Data Analysis|||||-13.86|-21.55|<0.001
91724919|NCT01405911|183344332|OTHER||Difference in Least Squares Means|-16.41|||<|0.001|TWO_SIDED|95.0|-20.32|-12.5|||Constrained Longitudinal Data Analysis|||||-12.50|-20.32|<0.001
91724920|NCT01405911|183344332|OTHER||Difference in Least Squares Means|1.3||||0.469|TWO_SIDED|95.0|-2.22|4.82|||Constrained Longitudinal Data Analysis|||||4.82|-2.22|0.469
91724921|NCT01059851|183344363|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval \[0.50, 2.00\], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.93|1.6|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants."||1.60|0.93|
91490057|NCT03576495|182852788|SUPERIORITY||Difference between percentage|0.0||||1|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' preparation for caring for culturally diverse patients improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident preparedness assessed by the Cross-Cultural Care Survey, resident preparedness was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||1.000
91490058|NCT03576495|182852789|SUPERIORITY||Percent difference|0.9||||0.6295|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' self-assessed skills improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident skills, resident skills were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.6295
91490059|NCT03576495|182852790|SUPERIORITY||Difference between percentage|2.5||||0.0199|TWO_SIDED||||||Fisher Exact|||"We conducted a superiority statistical test to assess if residents' beliefs improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident beliefs, beliefs were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.0199
91490060|NCT03576495|182852791|SUPERIORITY||difference in the percentage|2.2||||0.2665|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Limited English Proficiency and Informed Consent OSCE."||||0.2665
91490061|NCT03576495|182852791|SUPERIORITY||difference in the percentage|6.2||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Trust and Pain."||||0.0001
91490062|NCT03576495|182852792|SUPERIORITY||absolute difference between percentage|3.19||||0.5079|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to trust at time period 2."||||0.5079
91490063|NCT03576495|182852792|SUPERIORITY||absolute difference between percentage|1.92||||0.1571|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the curriculum, patient satisfaction was compared at Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to limited English proficiency at period 2."||||0.1571
91528102|NCT01118455|182931453|SUPERIORITY_OR_OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||||||0.727
91724922|NCT04937387|183344367|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0449|||TWO_SIDED|95.0|-0.03|0.147|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.147|-0.030|
91724923|NCT04937387|183344367|OTHER||Posterior Mean|0.076|||||TWO_SIDED|90.0|0.025|0.115|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.115|0.025|
91724924|NCT04937387|183344367|OTHER||Posterior Median|0.079|||||TWO_SIDED|95.0|0.005|0.123|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.123|0.005|
91724925|NCT04937387|183344368|OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0455|||TWO_SIDED|95.0|-0.094|0.084|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.084|-0.094|
91724926|NCT04937387|183344368|OTHER||Posterior Mean|0.023|||||TWO_SIDED|90.0|-0.071|0.103|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.103|-0.071|
91724927|NCT04937387|183344368|OTHER||Posterior Median|0.023||||||95.0|-0.086|0.11|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.110|-0.086|
91724928|NCT04937387|183344369|OTHER||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0823|||TWO_SIDED|95.0|-0.19|0.134|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.134|-0.190|
91724929|NCT04937387|183344369|OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.052|0.276|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.276|-0.052|
91724930|NCT01039675|183344370|NON_INFERIORITY_OR_EQUIVALENCE|UMEC/VI will be declared non-inferior to placebo in terms of weighted mean pulse rate if the upper limit of the 95% confidence interval around the estimated treatment difference for weighted mean pulse rate is less than the non-inferiority margin of +10bpm.|Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-5.5|4.5|||||Estimated from repeated measures analysis of covariance.|||4.5|-5.5|
91724931|NCT06901544|183344395|OTHER|Comparison of 28-day mortality between groups using chi-squared test.||||||0.001|||||||Chi-squared|||||||0.001
91724932|NCT06901544|183344396|SUPERIORITY||Mean Difference (Final Values)|0.243||||0.243|TWO_SIDED|95.0|-0.567|2.207|||t-test, 2 sided|||||2.207|-0.567|0.243
91724933|NCT06901544|183344397|OTHER|Comparison of mean PCT levels between groups using two-sample t-test.|Mean Difference (Final Values)|7.97||||0.037|TWO_SIDED|95.0|0.54|15.4|||t-test, 2 sided|||||15.40|0.54|0.037
91724934|NCT01807520|183344401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.7|STANDARD_ERROR_OF_MEAN|6.26|<|0.0001|TWO_SIDED|95.0|-39.1|-14.3|||Mixed model reapeated measures|||||-14.3|-39.1|<0.0001
91528103|NCT01118455|182931453|SUPERIORITY_OR_OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
91724935|NCT01807520|183344401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.4|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|-45.2|-23.5|||Mixed model repeated measures|||||-23.5|-45.2|<0.0001
91724936|NCT01258855|183344405|OTHER|||||||0.002|||||||Log Rank|||||||0.002
91724937|NCT01258855|183344406|OTHER|||||||0.43|||||||Log Rank|||||||0.43
91528104|NCT01118455|182931453|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
91528105|NCT01118455|182931453|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
91724938|NCT01258855|183344409|OTHER|||||||0.003|||||||Log Rank|||||||0.003
91528106|NCT01118455|182931454|SUPERIORITY_OR_OTHER|||||||0.448||95.0|||||t-test, 2 sided|||||||0.448
91528107|NCT01118455|182931454|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||t-test, 2 sided|||||||0.025
91528108|NCT01118455|182931454|SUPERIORITY_OR_OTHER|||||||0.799|||||||t-test, 2 sided|||||||0.799
91528109|NCT01118455|182931454|SUPERIORITY_OR_OTHER|||||||0.142|||||||t-test, 2 sided|||||||0.142
91528110|NCT01118455|182931455|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||t-test, 2 sided|||||||0.714
91528111|NCT01118455|182931455|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
91724939|NCT01258855|183344410|OTHER|||||||0.02|||||||Log Rank|||||||0.02
91724940|NCT02400736|183344428|SUPERIORITY|"Proportion of steady workers in each group was analyzed using a logistic regression model to calculate an odds ratio and 95% Confidence Interval. Adhering to the principle of intent-to-treat, participants were retained in the arm to which they were randomized for the 12-month follow-up period despite discontinuing the treatment intervention or exiting the study early. Missing data was counted as not worked."|Odds Ratio (OR)|2.49||||0.02|TWO_SIDED|95.0|1.14|5.43||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||Using SamplePower 3.0 to estimate the statistical power, the target sample size of 120 (60 per group) provided 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving 'steady worker' status (e.g., 40% in IPS vs. 15% in control arm), at the .05 level of significance, assuming a 10% attrition.||5.43|1.14|0.02
91724941|NCT02400736|183344429|SUPERIORITY|Intent to treat analysis.||||||0.003||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||Total mean time worked was compared using an analysis of variance (ANOVA).||||0.003
91724942|NCT02400736|183344430|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|||intent to treat analysis||||0.005
91724943|NCT02400736|183344431|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.033|||||||t-test, 2 sided|||||||0.033
91724944|NCT02400736|183344432|SUPERIORITY|||||||0.853||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||||||0.853
91724945|NCT02400736|183344433|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.004|||||||t-test, 2 sided|||||||0.004
91724946|NCT02400736|183344434|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||The effect of treatment on each of secondary outcome measures were analyzed using a longitudinal mixed-effects regression model. The group by time interaction tested for the treatment effect.||||0.47
91724947|NCT02400736|183344435|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.062
91724948|NCT02400736|183344436|SUPERIORITY||||||>|0.3||||||a priori threshold for statistical significance p \</= 0.05 or lower. No adjustments were made for multiple comparisons.|ANOVA|||||||>0.3
91724949|NCT02400736|183344437|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.001
91724950|NCT02400736|183344438|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||||||0.006
91724951|NCT01771913|183344439|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.310
91724952|NCT01771913|183344440|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.026
91724953|NCT01771913|183344441|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.103
91724954|NCT01779362|183344459|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
91724955|NCT01779362|183344460|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
91724956|NCT01779362|183344461|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
91724957|NCT01779362|183344462|SUPERIORITY||||||<|0.001||||||For all 3 secondary outcomes at M12, p\<0.001, with the Liraglutide+Metformin group different from the 3 others (all p\<0.001).|ANOVA|||Analyses were completed on a log scale and re-exponentiated for display.||||<0.001
91724958|NCT01177410|183344467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.369||||0.0432|TWO_SIDED|95.0|1.027|5.467|||Regression, Logistic|||||5.467|1.027|0.0432
91490064|NCT03576495|182852792|SUPERIORITY||absolute difference between percentage|4.76||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to consent at time period 2."||||0.0001
91724959|NCT01177410|183344467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.267||||0.6059|TWO_SIDED|95.0|0.515|3.115|||Regression, Logistic|||||3.115|0.515|0.6059
91724960|NCT01177410|183344468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.232||||0.0327|TWO_SIDED|95.0|1.068|4.664|||Proportional Odds Model|||Proportional odds model was used to compare the number of months the subjects are responders.||4.664|1.068|0.0327
91724961|NCT01177410|183344468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.148||||0.726|TWO_SIDED|95.0|0.531|2.483|||Proportional Odds Model|||||2.483|0.531|0.7260
91490065|NCT03576495|182852792|SUPERIORITY||absolute difference between percentage|0.19||||0.2956|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to pain at time period 2."||||0.2956
91724962|NCT00471354|183344469|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Spearman Partial Rank Order Correlation|||||||0.293
91528112|NCT01118455|182931455|SUPERIORITY_OR_OTHER|||||||0.467|||||||t-test, 2 sided|||||||0.467
91724963|NCT00471354|183344470|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||P-value for Correlation with Language Scores|Spearman Partial Rank Order Correlation|||||||0.276
91724964|NCT00471354|183344470|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for Correlation with Math Scores.|Spearman Partial Rank Order Correlation|||||||0.110
91724965|NCT00471354|183344470|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for Correlation with Science Scores.|Spearman Partial Rank Order Correlation|||||||0.464
91724966|NCT00471354|183344471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Language Scores.|Paired t-test|||||||<0.001
91724967|NCT00471354|183344471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Math Scores.|Paired t-test|||||||<0.001
91724968|NCT00471354|183344471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Science Scores.|Paired t-test|||||||<0.001
91724969|NCT00471354|183344471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Total Scores.|Paired t-test|||||||<0.001
91724970|NCT00471354|183344472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
91724971|NCT00471354|183344473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
91724972|NCT00471354|183344475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
91724973|NCT05558410|183344476|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91724974|NCT05558410|183344477|SUPERIORITY|||||||0.2781|||||||ANCOVA|||||||0.2781
91724975|NCT05558410|183344478|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
91528113|NCT01118455|182931455|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|||||||0.654
91724976|NCT05558410|183344479|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
91724977|NCT05558410|183344480|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91724978|NCT05558410|183344481|SUPERIORITY||||||<|0.0001|||||||Pearson's chi-squared test|||||||<0.0001
91724979|NCT05558410|183344482|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91724980|NCT05558410|183344483|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
91724981|NCT05558410|183344484|SUPERIORITY|||||||0.0237|||||||Cochran-Mantel-Haenszel|||||||0.0237
91490066|NCT03576495|182852793|SUPERIORITY||Cox Proportional Hazard|5.31||||0.0028|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||We used Cox Proportional Hazard to assess time to discharge, with 5.31 days as the estimated value for the difference between the two groups.|"We conducted a superiority statistical test to assess if patients length of stay improved after resident exposure to the PACTS curriculum. Patient length of stay was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups to measure an effect of the PACTS intervention."||||0.0028
91694962|NCT00402688|183284978|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.045||||||95.0|-0.106|0.195|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).|||0.195|-0.106|
91694963|NCT00927862|183284986|NON_INFERIORITY_OR_EQUIVALENCE|Based on power calculations and feasibility, the minimum recruitment target for the randomized, PG-guided comparison was set at 500 patients. All qualifying parallel control patients were included, anticipated to number ≥1000. For hypothesis 1, the power to exclude inferiority of the modified PG arm vs standard PG arm at a margin (delta) of 5% with 250 patients per group at a 2-sided alpha \<0.05 is 87%, assuming a common standard deviation of 0.20.|Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|0.2|<|0.05|TWO_SIDED|95.0||||Comparisons between groups for primary endpoints were made using the unpaired T-test.|t-test, 2 sided|||Comparisons between groups for primary endpoints were made using the unpaired T-test. All consented, randomized patients who were successfully genotyped and received at least one dose of warfarin with at least one post-dose INR were included in efficacy analyses (modified intention to treat \[mITT\]).||||<0.05
91724982|NCT05558410|183344485|SUPERIORITY|||||||0.008|||||||Wilcoxon rank-sum|||||||0.0080
91724983|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
91724984|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paited t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
91724985|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724986|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724987|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724988|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724989|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724990|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724991|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
91724992|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724993|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91694964|NCT00820248|183284995|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.83|TWO_SIDED|95.0|0.6|1.5|||Regression, Cox||Hazard ratio of panitumumab vs cisplatin|The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.||1.50|0.60|0.83
91528114|NCT01118455|182931456|SUPERIORITY_OR_OTHER|||||||0.691|||||||ANOVA|||||||0.691
91694965|NCT00820248|183284996|SUPERIORITY||Cox Proportional Hazard|0.89||||0.66|TWO_SIDED|95.0|0.54|1.48|||Log Rank||hazard ratio for panitumumab vs cisplatin|||1.48|0.54|0.66
91694966|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|-0.226|||||TWO_SIDED|||||||||leftIFG (Change in Brain activity \[post minus pre\])||||
91694967|NCT04157296|183285017|SUPERIORITY||Median Difference (Final Values)|-0.309|||||TWO_SIDED|||||||||rightIFG (Change in Brain activity \[post minus pre\])||||
91694968|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|||||||||leftParietal (Change in Brain activity \[post minus pre\])||||
91724994|NCT01336972|183344489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724995|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724996|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724997|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724998|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91724999|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725000|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725001|NCT01336972|183344490|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725002|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725003|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91490067|NCT02628938|182852818|SUPERIORITY_OR_OTHER|||||||0.299|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth wash||||0.299
91490068|NCT02628938|182852818|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth wash||||0.007
91694969|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|0.324|||||TWO_SIDED|||||||||rightParietal (Change in Brain activity \[post minus pre\])||||
91694970|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||leftdACC (Change in Brain activity \[post minus pre\])||||
91490069|NCT02628938|182852818|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticks||||0.019
91694971|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|-0.067|||||TWO_SIDED|||||||||rightdACC (Change in Brain activity \[post minus pre\])||||
91694972|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|0.302|||||TWO_SIDED|||||||||leftInsula (Change in Brain activity \[post minus pre\])||||
91694973|NCT04157296|183285017|SUPERIORITY|rightInsula (Change in Brain activity \[post minus pre\])|Mean Difference (Final Values)|0.234|||||TWO_SIDED|||||||||rightInsula (Change in Brain activity \[post minus pre\])||||
91694974|NCT04157296|183285017|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|||||||||TCN (Change in Connectivity \[post minus pre\])||||
91694975|NCT04157296|183285018|SUPERIORITY|||||||0.241|||||||t-test, 1 sided|||||||0.241
91694976|NCT04157296|183285019|SUPERIORITY|||||||0.233|||||||t-test, 1 sided|||||||0.233
91694977|NCT04157296|183285020|SUPERIORITY|||||||0.042|||||||t-test, 1 sided|||||||0.042
91694978|NCT04157296|183285021|SUPERIORITY|||||||0.349|||||||t-test, 1 sided|||||||0.349
91725004|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725005|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding||||>0.05
91725006|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725007|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725008|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
91725009|NCT01336972|183344491|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
91725010|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
91490070|NCT02628938|182852818|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticks||||0.000
91490071|NCT02628938|182852818|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.000
91490072|NCT02628938|182852818|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.001
91490073|NCT02628938|182852819|SUPERIORITY_OR_OTHER|||||||0.496|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth wash||||0.496
91528115|NCT01118455|182931456|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
91490074|NCT02628938|182852819|SUPERIORITY_OR_OTHER|||||||0.244|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth wash||||0.244
91490075|NCT02628938|182852819|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticks||||0.19
91725011|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
91725012|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
91725013|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
91725014|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Test to compare treatment groups at Final Treatment||||||>0.05
91725015|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|paired t-test|||||||>0.05
91725016|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
91725017|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
91490076|NCT02628938|182852819|SUPERIORITY_OR_OTHER|||||||0.829|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticks||||0.829
91528116|NCT01118455|182931456|SUPERIORITY_OR_OTHER|||||||0.343|||||||ANOVA|||||||0.343
91528117|NCT01118455|182931456|SUPERIORITY_OR_OTHER|||||||0.295|||||||ANOVA|||||||0.295
91528118|NCT01622543|182931473|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.046|TWO_SIDED|95.0|1.0|2.53|||Log Rank|||||2.53|1.00|0.046
91528119|NCT01622543|182931474|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
91725018|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
91725019|NCT01336972|183344492|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||<0.05
91725020|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Final Treatment||||<0.05
91725021|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Post Treatment||||<0.05
91725022|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
91490077|NCT02628938|182852819|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.341
91490078|NCT02628938|182852819|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.82
91490079|NCT02628938|182852820|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth wash||||0.008
91490080|NCT02628938|182852820|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticks||||0.001
91490081|NCT02628938|182852820|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.02
91490082|NCT03855228|182852833|SUPERIORITY|||||||0.36|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.36
91490083|NCT03855228|182852833|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490084|NCT03855228|182852833|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490085|NCT03855228|182852833|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490086|NCT03855228|182852833|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490087|NCT03855228|182852833|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
91490088|NCT03855228|182852834|SUPERIORITY|||||||0.35|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.35
91490089|NCT03855228|182852834|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490090|NCT03855228|182852834|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91528120|NCT01622543|182931475|SUPERIORITY||Odds Ratio (OR)|2.09||||0.06|TWO_SIDED|95.0|0.96|4.55|||Cochran-Mantel-Haenszel|||||4.55|0.96|0.06
91490091|NCT03855228|182852834|SUPERIORITY|||||||0.03|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.03
91490092|NCT03855228|182852834|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490093|NCT03855228|182852834|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
91528121|NCT01622543|182931476|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.36|TWO_SIDED|95.0|0.78|1.98|||Log Rank|||||1.98|0.78|0.36
91490094|NCT03855228|182852835|SUPERIORITY|||||||0.77|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.77
91490095|NCT03855228|182852835|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490096|NCT03855228|182852835|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490097|NCT03855228|182852835|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490098|NCT03855228|182852835|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490099|NCT03855228|182852835|SUPERIORITY|||||||0.45|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.45
91490100|NCT03855228|182852836|SUPERIORITY|||||||0.99|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.99
91490101|NCT03855228|182852836|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490102|NCT03855228|182852836|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490103|NCT03855228|182852836|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490104|NCT03855228|182852836|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490105|NCT03855228|182852836|SUPERIORITY|||||||0.08|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.08
91490106|NCT03855228|182852837|SUPERIORITY|||||||0.85|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.85
91490107|NCT03855228|182852837|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490108|NCT03855228|182852837|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490109|NCT03855228|182852837|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490110|NCT03855228|182852837|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490111|NCT03855228|182852837|SUPERIORITY|||||||0.17|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.17
91490112|NCT03855228|182852838|SUPERIORITY|||||||0.88|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.88
91490113|NCT03855228|182852838|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490114|NCT03855228|182852838|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91694979|NCT03980145|183285023|SUPERIORITY|||||||0.405||||||Statistical significance set at .05|ANOVA|||Null hypothesis is no difference between the two groups||||.405
91694980|NCT03980145|183285023|SUPERIORITY|||||||0.133|||||||ANOVA|||Null hypothesis is no difference between pretest and posttest||||.133
91694981|NCT03980145|183285023|SUPERIORITY|||||||0.05|||||||ANOVA|||Evaluated the difference between the pretest and posttest within the conventional physical therapy group||||.050
91694982|NCT03980145|183285023|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.017|TWO_SIDED|95.0|0.015|0.124||p value was adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speed||.124|.015|.017
91694983|NCT03980145|183285024|SUPERIORITY|||||||0.369|||||||ANOVA|||Comparison of the impact between the two arms looking an improved walking endurance||||.369
91694984|NCT03980145|183285024|SUPERIORITY|||||||0.71|||||||ANOVA|||Evaluation of impact of end-effector robotic training alone||||.710
91694985|NCT03980145|183285024|SUPERIORITY|||||||0.682|||||||ANOVA|||Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttest||||.682
91725023|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
91725024|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
91725025|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725026|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725027|NCT01336972|183344496|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91528122|NCT01421589|182931477|SUPERIORITY_OR_OTHER|||||||0.02|||||||Regression, Linear|||Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.||||0.02
91725028|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
91725029|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
91725030|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
91725031|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
91725032|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare PostTreatment versus Baseline for all treatment groups||||>0.05
91725033|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725034|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725035|NCT01336972|183344497|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||<0.05
91725036|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired te-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
91725037|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
91725038|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
91725039|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
91725040|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
91725041|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
91725042|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
91725043|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725044|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725045|NCT01336972|183344498|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
91725046|NCT03446573|183344499|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.|Adjusted difference in proportion (ADP)|-0.3|||||TWO_SIDED|95.0|-1.2|0.7|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.7|-1.2|
91725047|NCT03446573|183344500|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.|Adjusted difference in proportion|0.2|||||TWO_SIDED|95.0|-3.4|3.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).|||3.9|-3.4|
91725048|NCT03446573|183344526|OTHER||Treatment ratio|1.057||||0.257|TWO_SIDED|95.0|0.96|1.164|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.|||1.164|0.960|0.257
91725049|NCT03446573|183344526|OTHER||Treatment ratio|1.062||||0.35|TWO_SIDED|95.0|0.936|1.205|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.|||1.205|0.936|0.350
91528123|NCT01421589|182931478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91528124|NCT01421589|182931479|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91725050|NCT03446573|183344526|OTHER||Treatment ratio|0.979||||0.473|TWO_SIDED|95.0|0.924|1.037|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.|||1.037|0.924|0.473
91725051|NCT03446573|183344526|OTHER||Treatment ratio|0.956||||0.212|TWO_SIDED|95.0|0.891|1.026|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.|||1.026|0.891|0.212
91725052|NCT03446573|183344528|OTHER||Treatment ratio|0.977||||0.7|TWO_SIDED|95.0|0.866|1.102|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 96 has been presented.|||1.102|0.866|0.700
91725053|NCT03446573|183344528|OTHER||Treatment ratio|0.971||||0.7|TWO_SIDED|95.0|0.835|1.129|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 144 has been presented.|||1.129|0.835|0.700
91725054|NCT03446573|183344528|OTHER||Treatment ratio|0.969||||0.356|TWO_SIDED|95.0|0.907|1.036|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 96 has been presented.|||1.036|0.907|0.356
91490115|NCT03855228|182852838|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490116|NCT03855228|182852838|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490117|NCT03855228|182852838|SUPERIORITY|||||||0.22|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.22
91725055|NCT03446573|183344528|OTHER||Treatment ratio|0.991||||0.814|TWO_SIDED|95.0|0.916|1.071|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 144 has been presented.|||1.071|0.916|0.814
91725056|NCT03446573|183344529|OTHER||Treatment ratio|0.958||||0.56|TWO_SIDED|95.0|0.83|1.106|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.|||1.106|0.830|0.560
91725057|NCT03446573|183344529|OTHER||Treatment ratio|1.055||||0.489|TWO_SIDED|95.0|0.906|1.229|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.|||1.229|0.906|0.489
91725058|NCT03446573|183344531|OTHER||Treatment ratio|1.165||||0.081|TWO_SIDED|95.0|0.981|1.384|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 96 has been presented.|||1.384|0.981|0.081
91725059|NCT03446573|183344531|OTHER||Treatment ratio|0.981||||0.834|TWO_SIDED|95.0|0.819|1.175|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 144 has been presented.|||1.175|0.819|0.834
91725060|NCT03446573|183344532|OTHER||Treatment ratio|1.017||||0.758|TWO_SIDED|95.0|0.915|1.13|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.|||1.130|0.915|0.758
91725061|NCT03446573|183344532|OTHER||Treatment ratio|0.999||||0.985|TWO_SIDED|95.0|0.894|1.116|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.|||1.116|0.894|0.985
91725062|NCT03446573|183344534|OTHER||Treatment ratio|1.015||||0.806|TWO_SIDED|95.0|0.904|1.139|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 96 has been presented.|||1.139|0.904|0.806
91725063|NCT03446573|183344534|OTHER||Treatment ratio|1.019||||0.745|TWO_SIDED|95.0|0.909|1.142|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 144 has been presented.|||1.142|0.909|0.745
91725064|NCT03446573|183344535|OTHER||Treatment ratio|0.935||||0.264|TWO_SIDED|95.0|0.83|1.052|||Mixed Model Reported Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.|||1.052|0.830|0.264
91725065|NCT03446573|183344535|OTHER||Treatment ratio|0.996||||0.932|TWO_SIDED|95.0|0.903|1.098|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.|||1.098|0.903|0.932
91725066|NCT03446573|183344537|OTHER||Treatment ratio|1.15||||0.011|TWO_SIDED|95.0|1.032|1.281|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 96 has been presented.|||1.281|1.032|0.011
91725067|NCT03446573|183344537|OTHER||Treatment ratio|1.007||||0.895|TWO_SIDED|95.0|0.905|1.121|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 144 has been presented.|||1.121|0.905|0.895
91725068|NCT03446573|183344545|OTHER||Mean Difference (Net)|0.29||||0.047|TWO_SIDED|95.0|0.0|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented|||0.57|0.00|0.047
91725069|NCT03446573|183344545|OTHER||Mean Difference (Net)|0.31||||0.094|TWO_SIDED|95.0|-0.05|0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented|||0.68|-0.05|0.094
91725070|NCT03446573|183344545|OTHER||Mean Difference (Net)|-1.34|||<|0.001|TWO_SIDED|95.0|-2.01|-0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented|||-0.68|-2.01|<0.001
91725071|NCT03446573|183344545|OTHER||Mean Difference (Net)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.59|-1.09|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented|||-1.09|-2.59|<0.001
91725072|NCT03446573|183344545|OTHER||Mean Difference (Net)|2.1||||0.066|TWO_SIDED|95.0|-0.1|4.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented|||4.3|-0.1|0.066
91725073|NCT03446573|183344545|OTHER||Mean Difference (Net)|2.9||||0.046|TWO_SIDED|95.0|0.0|5.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented|||5.8|0.0|0.046
91725074|NCT03446573|183344545|OTHER||Mean Difference (Net)|0.0381||||0.005|TWO_SIDED|95.0|0.0117|0.0646|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented|||0.0646|0.0117|0.005
91725075|NCT03446573|183344545|OTHER||Mean Difference (Net)|0.0292||||0.032|TWO_SIDED|95.0|0.0025|0.0559|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented|||0.0559|0.0025|0.032
91725076|NCT03446573|183344547|OTHER||Mean Difference (Net)|0.17||||0.386|TWO_SIDED|95.0|-0.22|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 96 has been presented|||0.57|-0.22|0.386
91490118|NCT03855228|182852839|SUPERIORITY|||||||0.65|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.65
91490119|NCT03855228|182852839|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490120|NCT03855228|182852839|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490121|NCT03855228|182852839|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490122|NCT03855228|182852839|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91490123|NCT03855228|182852839|SUPERIORITY|||||||0.92|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.92
91490124|NCT03855228|182852840|SUPERIORITY|||||||0.95|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.95
91490125|NCT03855228|182852840|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
91725077|NCT03446573|183344547|OTHER||Mean Difference (Net)|0.14||||0.573|TWO_SIDED|95.0|-0.34|0.61|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 144 has been presented|||0.61|-0.34|0.573
91725078|NCT03446573|183344547|OTHER||Mean Difference (Net)|-1.87|||<|0.001|TWO_SIDED|95.0|-2.7|-1.04|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 96 has been presented|||-1.04|-2.70|< 0.001
91725079|NCT03446573|183344547|OTHER||Mean Difference (Net)|-1.95|||<|0.001|TWO_SIDED|95.0|-2.77|-1.14|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 144 has been presented|||-1.14|-2.77|< 0.001
91725080|NCT03446573|183344547|OTHER||Mean Difference (Net)|2.1||||0.082|TWO_SIDED|95.0|-0.3|4.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 96 has been presented.|||4.4|-0.3|0.082
91725081|NCT03446573|183344547|OTHER||Mean Difference (Net)|0.4||||0.765|TWO_SIDED|95.0|-2.3|3.2|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 144 has been presented|||3.2|-2.3|0.765
91725082|NCT03446573|183344547|OTHER||Mean Difference (Net)|0.0151||||0.301|TWO_SIDED|95.0|-0.0136|0.0438|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 96 has been presented|||0.0438|-0.0136|0.301
91490126|NCT03855228|182852840|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91694986|NCT03980145|183285024|SUPERIORITY|||||||0.568||||||p value adjusted for multiple comparisons - Bonferroni|ANOVA|||Evaluating the impact of whether both groups combined resulted in a significant change in walking distance||||.568
91694987|NCT03980145|183285025|SUPERIORITY|||||||0.594||||||Outcome specific to the physical domain|ANOVA|||Evaluation of the physical domain||||.594
91694988|NCT03980145|183285025|SUPERIORITY|||||||0.061|||||||ANOVA|||Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domain||||.061
91694989|NCT03980145|183285025|SUPERIORITY|||||||0.812|||||||ANOVA|||Pretest posttest comparison of conventional training group for physical domain||||.812
91694990|NCT03980145|183285025|SUPERIORITY|||||||0.235|||||||ANOVA|||Combined conventional and end-effector training for outcomes in the physical domain||||.235
91694991|NCT03980145|183285025|SUPERIORITY|||||||0.465|||||||ANOVA|||Between group assessment of changes in the MFIS Cognitive domain||||.465
91694992|NCT03980145|183285025|SUPERIORITY|||||||0.165|||||||ANOVA|||Within group differences for the End Effector Robotic Training Group for the Cognitive Domain||||.165
91725083|NCT03446573|183344547|OTHER||Mean Difference (Net)|0.0126||||0.34|TWO_SIDED|95.0|-0.0133|0.0384|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 144 has been presented|||0.0384|-0.0133|0.340
91725084|NCT03446573|183344548|OTHER||Mean Difference (Net)|-2.2||||0.173|TWO_SIDED|95.0|-5.3|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented|||1.0|-5.3|0.173
91490127|NCT03855228|182852840|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
91490128|NCT03855228|182852840|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
91694993|NCT03980145|183285025|SUPERIORITY|||||||0.682|||||||ANOVA|||Within group assessment for the conventional group within the cognitive domain of the MFIS||||.682
91694994|NCT03980145|183285025|SUPERIORITY||Mean Difference (Final Values)|5.39||||0.017|TWO_SIDED|95.0|1.12|9.67||p value adjusted using a Bonferroni correction|ANOVA|||Combined group outcomes comparing pretest to posttest for the cognitive domain||9.67|1.12|.017
91694995|NCT03980145|183285025|SUPERIORITY|||||||0.052|||||||ANOVA|||Between group comparison for the MFIS Psychological Subscale||||.052
91694996|NCT03980145|183285025|SUPERIORITY|||||||0.483|||||||ANOVA|||Within group comparison for the end-effector robotic training group for the MFIS Psychological subscale||||.483
91694997|NCT03980145|183285025|SUPERIORITY|||||||0.056|||||||ANOVA|||Within group assessment for the conventional physical therapy group for the MFIS Psychological subscale||||.056
91694998|NCT03980145|183285025|SUPERIORITY||Mean Difference (Final Values)|1.313||||0.048|TWO_SIDED|95.0|0.016|2.619||p value is adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Change in MFIS for all subjects from pre to posttest for the psychological subscale||2.619|.016|.048
91694999|NCT03980145|183285025|SUPERIORITY|||||||0.01|||||||ANOVA|||Between group assessment of differences in total score||||.010
91695000|NCT03980145|183285025|SUPERIORITY|||||||0.089|||||||ANOVA|||Within assessment of change in total fatigue score||||.089
91725085|NCT03446573|183344548|OTHER||Mean Difference (Net)|-2.3||||0.168|TWO_SIDED|95.0|-5.5|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented|||1.0|-5.5|0.168
91725086|NCT03446573|183344550|OTHER||Mean Difference (Net)|-9.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 96 has been presented.|||-4.7|-14.0|<0.001
91725087|NCT03446573|183344550|OTHER||Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.4|-1.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 144 has been presented.|||-1.7|-9.4|0.005
91725088|NCT03446573|183344551|OTHER||Mean Difference (Net)|-0.01||||0.027|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented|||0.00|-0.03|0.027
91725089|NCT03446573|183344551|OTHER||Mean Difference (Net)|-0.01||||0.061|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented|||0.00|-0.03|0.061
91725090|NCT03446573|183344553|OTHER||Mean Difference (Net)|-0.03||||0.004|TWO_SIDED|95.0|-0.06|-0.01|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 96 has been presented|||-0.01|-0.06|0.004
91725091|NCT03446573|183344553|OTHER||Mean Difference (Net)|-0.01||||0.094|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 144 has been presented|||0.00|-0.03|0.094
91725092|NCT03446573|183344554|OTHER||Mean Difference (Net)|1.8||||0.012|TWO_SIDED|95.0|0.4|3.1|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented|||3.1|0.4|0.012
91725093|NCT03446573|183344554|OTHER||Mean Difference (Net)|1.6||||0.059|TWO_SIDED|95.0|-0.1|3.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented|||3.3|-0.1|0.059
91725094|NCT03446573|183344554|OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-6.3|-3.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented|||-3.7|-6.3|<0.001
91725095|NCT03446573|183344554|OTHER||Mean Difference (Net)|-4.8|||<|0.001|TWO_SIDED|95.0|-6.1|-3.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented|||-3.4|-6.1|<0.001
91725096|NCT03446573|183344556|OTHER||Mean Difference (Net)|4.1||||0.002|TWO_SIDED|95.0|1.5|6.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 96 has been presented|||6.7|1.5|0.002
91725097|NCT03446573|183344556|OTHER||Mean Difference (Net)|1.9||||0.064|TWO_SIDED|95.0|-0.1|3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 148 has been presented|||3.8|-0.1|0.064
91725098|NCT03446573|183344556|OTHER||Mean Difference (Net)|-5.2|||<|0.001|TWO_SIDED|95.0|-6.7|-3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 96 has been presented|||-3.8|-6.7|<0.001
91725099|NCT03446573|183344556|OTHER||Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.2|-2.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 144 has been presented|||-2.8|-6.2|<0.001
91725100|NCT03446573|183344557|OTHER||Mean Difference (Net)|4.37|||<|0.001|TWO_SIDED|95.0|3.03|5.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.|||5.70|3.03|<0.001
91725101|NCT03446573|183344557|OTHER||Mean Difference (Net)|4.49|||<|0.001|TWO_SIDED|95.0|3.18|5.81|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.|||5.81|3.18|<0.001
91725102|NCT03446573|183344559|OTHER||Mean Difference (Net)|4.95|||<|0.001|TWO_SIDED|95.0|3.47|6.43|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 96 has been presented.|||6.43|3.47|<0.001
91725103|NCT03446573|183344559|OTHER||Mean Difference (Net)|4.08|||<|0.001|TWO_SIDED|95.0|2.32|5.85|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 144 has been presented.|||5.85|2.32|<0.001
91725104|NCT03446573|183344560|OTHER||Mean Difference (Net)|-0.0017||||0.741|TWO_SIDED|95.0|-0.0119|0.0085|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0085|-0.0119|0.741
91725105|NCT03446573|183344560|OTHER||Mean Difference (Net)|0.0015||||0.792|TWO_SIDED|95.0|-0.0094|0.0123|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0123|-0.0094|0.792
91490129|NCT03855228|182852840|SUPERIORITY|||||||0.58|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.58
91725106|NCT03446573|183344561|OTHER||Mean Difference (Net)|0.0003||||0.965|TWO_SIDED|95.0|-0.0121|0.0126|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0126|-0.0121|0.965
91725107|NCT03446573|183344561|OTHER||Mean Difference (Net)|-0.0109||||0.12|TWO_SIDED|95.0|-0.0247|0.0029|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0029|-0.0247|0.120
91490130|NCT03855228|182852841|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
91490131|NCT03855228|182852841|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490132|NCT03855228|182852841|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91725108|NCT03446573|183344562|OTHER||Mean Difference (Net)|-0.1||||0.879|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||1.2|-1.4|0.879
91725109|NCT03446573|183344562|OTHER||Mean Difference (Net)|-0.5||||0.414|TWO_SIDED|95.0|-1.9|0.8|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.8|-1.9|0.414
91490133|NCT03855228|182852841|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490134|NCT03855228|182852841|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490135|NCT03855228|182852841|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.80
91490136|NCT03855228|182852842|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
91490137|NCT03855228|182852842|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490138|NCT03855228|182852842|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490139|NCT03855228|182852842|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490140|NCT03855228|182852842|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91490141|NCT03855228|182852842|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
91528125|NCT01421589|182931480|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91725110|NCT03446573|183344563|OTHER||Mean Difference (Net)|-1.2||||0.102|TWO_SIDED|95.0|-2.5|0.2|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.5|0.102
91725111|NCT03446573|183344563|OTHER||Mean Difference (Net)|-1.3||||0.093|TWO_SIDED|95.0|-2.8|0.2|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.8|0.093
91725112|NCT00471107|183344607|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Power analysis was based on WMS-III Word Lists performance. With an effect comparable to the effect on verbal fluency in an earlier study of left frontal TDCS in healthy subjects, it would require 10 subjects per group (30 total) for a significance level of 0.05 and 80% power.||||>0.05
91725113|NCT06204887|183344634|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91725114|NCT03833167|183344651|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.07243|TWO_SIDED|95.0|0.53|1.1||One-sided p-value based on log-rank test stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||1.10|0.53|0.07243
91725115|NCT03833167|183344652|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.87|2.48|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||2.48|0.87|
91725116|NCT03833167|183344653|SUPERIORITY||Mean Difference (Final Values)|-3.41||||0.2227|TWO_SIDED|95.0|-8.91|2.09||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||2.09|-8.91|0.2227
91725117|NCT03833167|183344654|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.1874|TWO_SIDED|95.0|-7.19|1.42||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||1.42|-7.19|0.1874
91725118|NCT03003962|183344674|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.84||||0.037|TWO_SIDED|95.0|0.706|0.989|||Stratified Log-rank test||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model|||0.989|0.706|0.037
91528126|NCT01421589|182931481|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91725119|NCT03003962|183344675|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.96||||0.628|TWO_SIDED|95.0|0.793|1.151|||Stratified log-rank test||The HR and CI were calculated using a stratified Cox proportional hazards model.|||1.151|0.793|0.628
91725120|NCT04337021|183344741|SUPERIORITY|||||||0.513|||||||Chi-squared|||There were no statistical differences between the two treatment groups (chi-square=0.43, p=0.513)||||0.513
91490142|NCT02400333|182852859|SUPERIORITY_OR_OTHER||Geometric mean ratio|84.85|||||TWO_SIDED|90.0|76.77|93.78||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||93.78|76.77|
91490143|NCT02400333|182852859|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.61|||||TWO_SIDED|95.0|88.22|105.79||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||105.79|88.22|
91490144|NCT02400333|182852859|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.16|||||TWO_SIDED|95.0|85.59|99.25||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.25|85.59|
91490145|NCT02400333|182852859|SUPERIORITY_OR_OTHER||Geometric mean ratio|89.84|||||TWO_SIDED|95.0|82.03|98.39||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.39|82.03|
91490146|NCT02400333|182852859|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.45|||||TWO_SIDED|95.0|90.53|104.9||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||104.90|90.53|
91490147|NCT02400333|182852859|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.07|||||TWO_SIDED|95.0|90.83|103.74||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||103.74|90.83|
91528127|NCT01421589|182931482|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91528128|NCT01421589|182931483|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91528129|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.4|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.4
91725121|NCT04337021|183344742|SUPERIORITY|||||||0.184|||||||Mixed Models Analysis|||||||.184
91725122|NCT04337021|183344743|SUPERIORITY|||||||0.525|||||||Chi-squared|||||||0.525
91725123|NCT04337021|183344744|SUPERIORITY|||||||0.723|||||||Chi-squared|||||||0.723
91725124|NCT04337021|183344745|SUPERIORITY|||||||0.569|||||||Chi-squared|||||||0.569
91725125|NCT06375655|183344746|OTHER||Odds Ratio (OR)|0.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
91725126|NCT06375655|183344747|SUPERIORITY||Odds Ratio (OR)|1.901509||||0.5007|TWO_SIDED|95.0|0.41|10.25|||Fisher Exact|||This analysis did not power the study||10.25|0.41|0.5007
91725127|NCT06375655|183344748|SUPERIORITY||Odds Ratio (OR)|4.43||||0.3497|TWO_SIDED|95.0|0.3986|232.3218|||Fisher Exact|||||232.3218|0.3986|0.3497
91725128|NCT06375655|183344749|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.7
91695001|NCT03980145|183285025|SUPERIORITY|||||||0.5|||||||ANOVA|||Within group assessment of change in total score||||.50
91695002|NCT03980145|183285025|SUPERIORITY||Mean Difference (Final Values)|9.464||||0.1|TWO_SIDED|95.0|2.678|16.251|||ANOVA|||Combined assessment of all subject improvement in total MFIS score||16.251|2.678|0.10
91695003|NCT03980145|183285026|SUPERIORITY|||||||0.071|||||||ANOVA|||Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscale||||.071
91695004|NCT03980145|183285026|SUPERIORITY||Mean Difference (Final Values)|14.84||||0.005|TWO_SIDED|95.0|6.02|23.66|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||23.66|6.02|.005
91695005|NCT03980145|183285026|SUPERIORITY||Mean Difference (Final Values)|13.57||||0.001|TWO_SIDED|95.0|8.3|18.85|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||18.85|8.30|.001
91695006|NCT03980145|183285026|SUPERIORITY||Mean Difference (Final Values)|14.21||||2.6e-05|TWO_SIDED|95.0|9.367|19.04||p value adjusted for multiple comparisons using Bonferroni|ANOVA|||Combined group assessment of change on the physical subscale of the MSIS||19.04|9.367|.000026
91695007|NCT03980145|183285026|SUPERIORITY|||||||0.084||||||Pretest measures were statistically different between the two groups|ANOVA|||Between group comparison for the psychological subscale for the MSIS||||.084
91695008|NCT03980145|183285026|SUPERIORITY|||||||0.412|||||||ANOVA|||Within group comparison for the psychological subscale for the MSIS||||.412
91695009|NCT03980145|183285026|SUPERIORITY||Mean Difference (Final Values)|22.22||||0.00018|TWO_SIDED|95.0|15.59|28.85|||ANOVA|||Within group comparison for the psychological subscale for the MSIS||28.85|15.59|.00018
91695010|NCT03980145|183285026|SUPERIORITY||Mean Difference (Final Values)|13.19||||0.00049|TWO_SIDED|95.0|7.013|19.38|||ANOVA|||Combined group comparison for the psychological subscale for the MSIS||19.38|7.013|.00049
91695011|NCT03980145|183285027|SUPERIORITY|||||||0.352|||||||ANOVA|||Null hypothesis is no difference between the two groups||||.352
91695012|NCT03980145|183285027|SUPERIORITY|||||||0.079|||||||ANOVA|||Within group assessment||||.079
91695013|NCT03980145|183285027|SUPERIORITY|||||||0.393|||||||ANOVA|||Within group assessment||||.393
91695014|NCT03980145|183285027|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.048|TWO_SIDED|95.0|0.001|0.116|||ANOVA|Adjusted for multiple mean comparisons||Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speed||.116|.001|.048
91695015|NCT03980145|183285028|SUPERIORITY|||||||0.117|||||||ANOVA|||Between group assessment for the HADS Anxiety Subscale||||.117
91695016|NCT03980145|183285028|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.041|TWO_SIDED|95.0|0.093|3.407|||ANOVA|||Within group assessment for HADS Anxiety Subscale||3.407|.093|.041
91695017|NCT03980145|183285028|SUPERIORITY|||||||0.15|||||||ANOVA|||Within group assessment for HADS Anxiety Subscale||||.150
91695018|NCT03980145|183285028|SUPERIORITY||Mean Difference (Final Values)|1.518||||0.012|TWO_SIDED|95.0|0.39|2.646||p value adjusted for multiple comparisons|ANOVA|||Combined group assessment of HADS Anxiety Subscale||2.646|.390|.012
91695019|NCT03980145|183285029|SUPERIORITY|||||||0.239|||||||ANOVA|||||||.239
91695020|NCT03980145|183285029|SUPERIORITY|||||||0.667|||||||ANOVA|||Comparison between groups for differences in sensory pain score||||.667
91695021|NCT03980145|183285029|SUPERIORITY|||||||0.77|||||||ANOVA|||Between group differences in affective pain||||.770
91695022|NCT03980145|183285030|SUPERIORITY|||||||0.136|||||||ANOVA|||Between group assessment of LLFDI Disability Frequency||||.136
91695023|NCT03980145|183285030|SUPERIORITY|||||||0.833|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Frequency||||.833
91695024|NCT03980145|183285030|SUPERIORITY||Mean Difference (Final Values)|6.996||||0.044|TWO_SIDED|95.0|0.212|13.781|||ANOVA|||Between Group Assessment of improvement in LLFDI Disability Limitations||13.781|.212|.044
91695025|NCT03980145|183285030|SUPERIORITY|||||||0.212|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Limitations||||.212
91695026|NCT03980145|183285031|SUPERIORITY|||||||0.338|||||||ANOVA|||Between group comparison for the LLDFI Function||||.338
91695027|NCT03980145|183285031|SUPERIORITY||Mean Difference (Final Values)|7.508||||0.007|TWO_SIDED|95.0|2.73|12.28|||ANOVA|||Within group assessment of LLFDI Function||12.28|2.73|.007
91695028|NCT03980145|183285031|SUPERIORITY|||||||0.067|||||||ANOVA|||Within group assessment for changes in LLFDI Function||||.067
91695029|NCT03980145|183285031|SUPERIORITY||Mean Difference (Final Values)|5.99||||0.001|TWO_SIDED|95.0|2.9|9.08||p value adjusted for multiple comparisons|ANOVA|||Combined group improvement in LLFDI Function||9.08|2.90|.001
91695030|NCT02088905|183285033|SUPERIORITY|||||||0.08||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.080
91695031|NCT02088905|183285033|SUPERIORITY|||||||0.026||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.026
91695032|NCT02088905|183285033|OTHER|Type III Tests of Fixed Effects|||||<|0.001||||||Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||<.001
91695033|NCT02088905|183285033|OTHER|Type III Tests of Fixed Effects||||||0.182||||||Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.182
91695034|NCT02088905|183285033|OTHER|Type III Tests of Fixed Effects||||||0.015||||||Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.015
91695035|NCT02088905|183285034|SUPERIORITY|||||||0.203||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority||||.203
91695036|NCT02088905|183285034|SUPERIORITY|||||||0.17||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.17
91490148|NCT02400333|182852860|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.04|||||TWO_SIDED|95.0|90.33|99.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.99|90.33|
91490149|NCT02400333|182852860|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.41|||||TWO_SIDED|95.0|89.94|101.21||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||101.21|89.94|
91490150|NCT02400333|182852860|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.66|||||TWO_SIDED|95.0|90.53|98.98||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.98|90.53|
91490151|NCT02400333|182852860|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.67|||||TWO_SIDED|95.0|90.94|98.56||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.56|90.94|
91490152|NCT02400333|182852860|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.0|||||TWO_SIDED|95.0|91.87|100.33||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.33|91.87|
91490153|NCT02400333|182852860|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.56|||||TWO_SIDED|95.0|93.08|100.17||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||100.17|93.08|
91695037|NCT02088905|183285034|SUPERIORITY|||||||0.308||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.308
91695038|NCT02088905|183285034|SUPERIORITY|||||||0.413||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.413
91695039|NCT02088905|183285036|SUPERIORITY|||||||0.271||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.271
91695040|NCT02088905|183285036|SUPERIORITY|||||||0.434||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.434
91695041|NCT02088905|183285036|SUPERIORITY|||||||0.298||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority||||.298
91695042|NCT02088905|183285036|SUPERIORITY|||||||0.294||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.294
91695043|NCT02088905|183285036|SUPERIORITY|||||||0.441||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority||||.441
91695044|NCT02088905|183285036|SUPERIORITY|||||||0.204||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.204
91695045|NCT02088905|183285038|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority||||<.001
91695046|NCT02088905|183285038|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.||||<.001
91695047|NCT04922255|183285044|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91695048|NCT04922255|183285045|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||||||0.50
91695049|NCT04922255|183285046|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
91695050|NCT04922255|183285047|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.70
91695051|NCT04922255|183285048|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91695052|NCT00648115|183285062|SUPERIORITY_OR_OTHER||Pearson chi square|7.3|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91695053|NCT02064816|183285108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|3.5||0.277763|TWO_SIDED|95.0|-0.46|1.56|||Mann-Whitney Non Parametric test|||||1.56|-0.46|0.277763
91695054|NCT02064816|183285109|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|1.3492||||0.0083|TWO_SIDED|95.0|0.3495|2.3489|||linear mixed model for repeated measures|||Week 4||2.3489|0.3495|0.0083
91695055|NCT02064816|183285109|SUPERIORITY_OR_OTHER||LS Mean difference|1.3367||||0.0079|TWO_SIDED|95.0|0.3534|2.32|||linear mixed model for repeated measures|||Week 8||2.3200|0.3534|0.0079
91695056|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.4003||||0.4311|TWO_SIDED|95.0|-0.5992|1.3998|||linear mixed model for repeated measures|||ISRs subscale Week 4||1.3998|-0.5992|0.4311
91695057|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.08479||||0.8635|TWO_SIDED|95.0|-0.885|1.0546|||linear mixed model for repeated measures|||ISRs subscale Week 8||1.0546|-0.8850|0.8635
91695058|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3245||||0.5099|TWO_SIDED|95.0|-1.2927|0.6437|||linear mixed model for repeated measures|||ISRs subscale Week 12||0.6437|-1.2927|0.5099
91695059|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07079||||0.8574|TWO_SIDED|95.0|-0.8452|0.7036|||linear mixed model for repeated measures|||Global side-effect subscale: Week 4||0.7036|-0.8452|0.8574
91695060|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.1897||||0.6338|TWO_SIDED|95.0|-0.5926|0.972|||linear mixed model for repeated measures|||Global side-effect subscale: Week 8||0.9720|-0.5926|0.6338
91695061|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.4097||||0.3042|TWO_SIDED|95.0|-0.3734|1.1929|||linear mixed model for repeated measures|||Global side-effect subscale: Week 12||1.1929|-0.3734|0.3042
91695062|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4083||||0.1038|TWO_SIDED|95.0|-0.9008|0.08419|||linear mixed model for repeated measures|||Benefits: Week 4||0.08419|-0.9008|0.1038
91695063|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.1358||||0.594|TWO_SIDED|95.0|-0.637|0.3653|||linear mixed model for repeated measures|||Benefits: Week 8||0.3653|-0.6370|0.5940
91695064|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.05809||||0.8217|TWO_SIDED|95.0|-0.5651|0.4489|||linear mixed model for repeated measures|||Benefits: Week 12||0.4489|-0.5651|0.8217
91490154|NCT02400333|182852861|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.96|||||TWO_SIDED|95.0|90.27|99.89||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.89|90.27|
91490155|NCT02400333|182852861|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.24|||||TWO_SIDED|95.0|89.81|100.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.99|89.81|
91490156|NCT02400333|182852861|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.4|||||TWO_SIDED|95.0|90.26|98.73||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.73|90.26|
91695065|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.5909||||0.489|TWO_SIDED|95.0|-1.0873|2.269|||linear mixed model for repeated measures|||Description of pain: Week 4||2.2690|-1.0873|0.4890
91695066|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.7689||||0.3719|TWO_SIDED|95.0|-2.4607|0.9229|||linear mixed model for repeated measures|||Description of pain: Week 8||0.9229|-2.4607|0.3719
91695067|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.1422||||0.869|TWO_SIDED|95.0|-1.5521|1.8364|||linear mixed model for repeated measures|||Description of pain: Week 12||1.8364|-1.5521|0.8690
91695068|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.6544||||0.8328|TWO_SIDED|95.0|-5.4393|6.7482|||linear mixed model for repeated measures|||VAS: Week 4||6.7482|-5.4393|0.8328
91695069|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2294||||0.4764|TWO_SIDED|95.0|-8.38|3.9212|||linear mixed model for repeated measures|||VAS: Week 8||3.9212|-8.3800|0.4764
91695070|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-5.4196||||0.0852|TWO_SIDED|95.0|-11.5939|0.7547|||linear mixed model for repeated measures|||VAS: Week 12||0.7547|-11.5939|0.0852
91695071|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|0.006873||||0.9639|TWO_SIDED|95.0|-0.2918|0.3055|||linear mixed model for repeated measures|||Rating of pain: Week 4||0.3055|-0.2918|0.9639
91695072|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.08689||||0.5715|TWO_SIDED|95.0|-0.3886|0.2148|||linear mixed model for repeated measures|||Rating of pain: Week 8||0.2148|-0.3886|0.5715
91695073|NCT02064816|183285110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2224||||0.1502|TWO_SIDED|95.0|-0.5256|0.0809|||linear mixed model for repeated measures|||Rating of pain: Week 12||0.08090|-0.5256|0.1502
91695074|NCT01757184|183285125|SUPERIORITY|||||||0.0271|||||||Fisher Exact|Fisher's exact test at α=0.05.||A sample size of 50 randomized participants (approximately 25 participants per treatment group) provided 97% power to detect a statistically significant difference between sebelipase alfa and placebo, using Fisher's exact test at α=0.05.||||0.0271
91695075|NCT01757184|183285126|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91695076|NCT01757184|183285127|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91695077|NCT01757184|183285128|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
91695078|NCT01757184|183285129|SUPERIORITY|||||||0.0375|||||||Wilcoxon (Mann-Whitney)|||||||0.0375
91695079|NCT01757184|183285130|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91695080|NCT01757184|183285131|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91695081|NCT01757184|183285132|SUPERIORITY|||||||0.4216|||||||Fisher Exact|||||||0.4216
91695082|NCT01757184|183285133|SUPERIORITY|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
91695083|NCT04468347|183285136|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||<0.0001
91695084|NCT04468347|183285136|OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.038||0.0005|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.0005
91695085|NCT04468347|183285136|OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.033||0.2161|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.2161
91695086|NCT04468347|183285137|OTHER|||||||0.1998|||||||Cochran-Mantel-Haenszel|||||||0.1998
91725129|NCT06375655|183344750|SUPERIORITY||Odds Ratio (OR)|0.6909776||||0.2302|TWO_SIDED|95.0|0.4025454|1.1860776||Value at 1 month|Cochran-Mantel-Haenszel|||||1.1860776|0.4025454|0.2302
91725130|NCT06375655|183344750|SUPERIORITY||Odds Ratio (OR)|0.6909776||||0.3|TWO_SIDED|95.0|0.4025454|1.1860776||Value at 3 months|Cochran-Mantel-Haenszel|||||1.1860776|0.4025454|0.3
91725131|NCT06375655|183344750|SUPERIORITY||Odds Ratio (OR)|0.6909776||||0.3|TWO_SIDED|95.0|0.4025454|1.1860776||Value at 6 months|Cochran-Mantel-Haenszel|||||1.1860776|0.4025454|0.3
91725132|NCT06375655|183344751|SUPERIORITY||Odds Ratio (OR)|2.726859||||0.01692|TWO_SIDED|95.0|1.253958|5.929833||Value at 1 month postpartum|Cochran-Mantel-Haenszel|||||5.929833|1.253958|0.01692
91725133|NCT06375655|183344751|SUPERIORITY||Odds Ratio (OR)|2.726859||||0.7|TWO_SIDED|95.0|1.253958|5.929833||Value at 2 months postpartum|Cochran-Mantel-Haenszel|||||5.929833|1.253958|0.7
91725134|NCT06375655|183344751|SUPERIORITY||Odds Ratio (OR)|2.726859||||0.3|TWO_SIDED|95.0|1.253958|5.929833||Value at 3 months postpartum|Cochran-Mantel-Haenszel|||||5.929833|1.253958|0.3
91725135|NCT06375655|183344751|SUPERIORITY||Odds Ratio (OR)|2.726859||||0.15|TWO_SIDED|95.0|1.253958|5.929833||Value at 6 months postpartum|Cochran-Mantel-Haenszel|||||5.929833|1.253958|0.15
91725136|NCT00567580|183344761|SUPERIORITY||||||<|0.001||||||One-sided significance level = 0.001|Z test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
91725137|NCT00567580|183344761|SUPERIORITY|||||||0.003|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||0.003
91490157|NCT02400333|182852861|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.82|||||TWO_SIDED|95.0|91.36|98.42||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.42|91.36|
91490158|NCT02400333|182852861|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.71|||||TWO_SIDED|95.0|91.78|99.82||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||99.82|91.78|
91490159|NCT02400333|182852861|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|95.0|93.26|99.87||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.87|93.26|
91725138|NCT00567580|183344761|SUPERIORITY||||||<|0.001|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
91490160|NCT02468674|182852872|OTHER|||||||0.759|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.759
91725139|NCT00567580|183344762|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|97.5|0.45|0.72||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.72|0.45|<0.001
91725140|NCT00567580|183344762|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|97.5|0.51|0.89||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.89|0.51|<0.001
91725141|NCT00567580|183344762|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|97.5|0.3|0.51||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.51|0.30|<0.001
91725142|NCT00567580|183344763|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.137|TWO_SIDED|97.5|0.39|1.39||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.39|0.39|0.137
91725143|NCT00567580|183344763|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.007|TWO_SIDED|97.5|0.16|0.95||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.95|0.16|0.007
91725144|NCT00567580|183344763|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|97.5|0.12|0.68||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.68|0.12|<0.001
91490161|NCT02468674|182852872|OTHER|||||||0.5|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.500
91490162|NCT02468674|182852872|OTHER|||||||0.144|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.144
91490163|NCT02468674|182852872|OTHER|||||||0.648|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.648
91490164|NCT02468674|182852872|OTHER|||||||0.929|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.929
91725145|NCT00567580|183344764|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|97.5|0.14|1.01||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.01|0.14|0.010
91725146|NCT00567580|183344764|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.177|TWO_SIDED|97.5|0.14|2.3||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||2.30|0.14|0.177
91725147|NCT00567580|183344764|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|97.5|0.06|0.71||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.71|0.06|<0.001
91725148|NCT00567580|183344765|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.105|TWO_SIDED|97.5|0.49|1.22||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.22|0.49|0.105
91725149|NCT00567580|183344765|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.022|TWO_SIDED|97.5|0.36|1.06||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.06|0.36|0.022
91725150|NCT00567580|183344765|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|97.5|0.29|0.81||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.81|0.29|<0.001
91725151|NCT00567580|183344766|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.137|TWO_SIDED|97.5|0.35|1.43||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.43|0.35|0.137
91725152|NCT00567580|183344766|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.141|TWO_SIDED|97.5|0.3|1.54||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.54|0.30|0.141
91490165|NCT02468674|182852872|OTHER|||||||0.53|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.530
91490166|NCT02468674|182852873|OTHER|||||||0.839|||||||ANCOVA|Difference in the least square means (SE)||Population II: SPPB total score at Week 49||||0.839
91490167|NCT02468674|182852874|OTHER|||||||0.669|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.669
91490168|NCT02468674|182852874|OTHER|||||||0.773|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.773
91490169|NCT02468674|182852874|OTHER|||||||0.29|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.290
91490170|NCT02468674|182852874|OTHER|||||||0.766|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.766
91490171|NCT02468674|182852874|OTHER|||||||0.885|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.885
91490172|NCT02468674|182852874|OTHER|||||||0.84|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.840
91490173|NCT02468674|182852875|OTHER|||||||0.367|||||||ANCOVA|Difference in the least square means (SE)||Population II: 6MWT at Week 49||||0.367
91490174|NCT02468674|182852876|OTHER|||||||0.875|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.875
91490175|NCT02468674|182852876|OTHER|||||||0.909|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.909
91695087|NCT04468347|183285138|OTHER|||||||0.0646|||||||Cochran-Mantel-Haenszel|||||||0.0646
91695088|NCT00994461|183285139|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.|Cochran-Mantel-Haenszel|CMH test stratified by H. pylori status was employed. Continuous correction was used.||Hypothesis testing was conducted with significant p-value level of under 0.05.||||<0.0001
91695089|NCT04586244|183285151|SUPERIORITY|||||||0.0925|||||||paired t-test|The paired t-test used n-1 degrees of freedom, where n is the number of evaluable paired samples.||||||0.0925
91695090|NCT01779440|183285175|SUPERIORITY|||||||0.65||||||The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable.|Chi-squared|||||||0.65
91695091|NCT00550745|183285177|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||||95.0|0.91|1.73|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 42 Days postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.73|0.91|
91695092|NCT00550745|183285178|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||||95.0|0.98|1.32|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 6 months postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.32|0.98|
91695093|NCT00764660|183285180|SUPERIORITY_OR_OTHER||Difference in LS Means|2.4||||0.41|TWO_SIDED|95.0|-3.4|8.2|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||8.2|-3.4|0.41
91695094|NCT00764660|183285181|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-1.9||||0.3|TWO_SIDED|95.0|-5.5|1.7|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||1.7|-5.5|0.30
91695095|NCT00764660|183285182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|Zero Inflated Negative Binomial (ZINB) Distribution with terms for treatment and region||||1.33|0.57|0.52
91695096|NCT00764660|183285183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.31|||Chi-squared|ZINB Distribution with terms for treatment and region||||1.31|0.71|0.81
91695097|NCT00764660|183285184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.26|TWO_SIDED|95.0|0.81|2.12||Model with factors treatment and pooled centers as stratum.|Kaplan-Meier|||||2.12|0.81|0.26
91695098|NCT00764660|183285185|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.59|TWO_SIDED|95.0|-9.9|5.7|||Repeated Measures Model|Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||||5.7|-9.9|0.59
91695099|NCT00764660|183285186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.34|TWO_SIDED|95.0|0.65|3.43|||Regression, Logistic|An Odds Ratio (SCH 900435/Placebo) \>1 means SCH 900435 has a higher probability of achieving complete abstinence.||||3.43|0.65|0.34
91695100|NCT00764660|183285189|SUPERIORITY_OR_OTHER||Difference in LS Means|2.88||||0.54|TWO_SIDED|95.0|-6.3|12.06|||Contrained Longitudinal Data Analysis||Constrained Longitudinal Data Analysis (cLDA) Model with terms for treatment, pooled centers, assessment by treatment interaction.|||12.06|-6.30|0.54
91695101|NCT00764660|183285190|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.51|TWO_SIDED|95.0|-12.35|6.15|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||6.15|-12.35|0.51
91695102|NCT00764660|183285191|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.17||||0.05|TWO_SIDED|95.0|-18.27|-0.07|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||-0.07|-18.27|0.05
91695103|NCT00769067|183285205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.012|TWO_SIDED|95.0|0.472|0.914||2-Sided.|Log Rank|Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|"Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.~HR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors"||0.914|0.472|0.012
91695104|NCT00769067|183285206|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||2-Sided.|Chi-squared|Unadjusted.||||||0.011
91725153|NCT00567580|183344766|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.014|TWO_SIDED|97.5|0.21|1.03||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.03|0.21|0.014
91725154|NCT00567580|183344767|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.235|TWO_SIDED|97.5|0.54|1.38||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.38|0.54|0.235
91725155|NCT00567580|183344767|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.481|TWO_SIDED|97.5|0.61|1.6||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.60|0.61|0.481
91725156|NCT00567580|183344767|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.213|TWO_SIDED|97.5|0.53|1.35||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.35|0.53|0.213
91725157|NCT00567580|183344768|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.001|TWO_SIDED|97.5|1.81|3.37||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT Alone|Acute grade 2+ acute adverse events||3.37|1.81|<0.001
91725158|NCT00567580|183344768|SUPERIORITY||Odds Ratio (OR)|1.35||||0.007|TWO_SIDED|97.5|1.03|1.77||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT + STAD|Acute grade 2+ acute adverse events||1.77|1.03|0.007
91725159|NCT00567580|183344768|SUPERIORITY||Odds Ratio (OR)|2.04||||0.002|TWO_SIDED|97.5|1.16|3.6||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT Alone|Acute grade 3+ acute adverse events||3.60|1.16|0.002
91725160|NCT00567580|183344768|SUPERIORITY||Odds Ratio (OR)|1.47||||0.025|TWO_SIDED|95.0|0.975|2.27||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT + STAD|Acute grade 3+ adverse events||2.27|0.975|0.025
91725161|NCT00567580|183344769|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.268|TWO_SIDED|97.5|0.88|1.26||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 2+ adverse events||1.26|0.88|0.268
91725162|NCT00567580|183344769|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.101|TWO_SIDED|97.5|0.93|1.32||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 2+ adverse events||1.32|0.93|0.101
91725163|NCT00567580|183344769|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.119|TWO_SIDED|97.5|0.83|1.8||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 3+ adverse events||1.80|0.83|0.119
91490176|NCT02468674|182852876|OTHER|||||||0.168|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.168
91490177|NCT02468674|182852876|OTHER|||||||0.632|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.632
91490178|NCT02468674|182852876|OTHER|||||||0.31|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.310
91490179|NCT02468674|182852876|OTHER|||||||0.321|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.321
91725164|NCT00567580|183344769|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.17|TWO_SIDED|97.5|0.82|1.65||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 3+ adverse events||1.65|0.82|0.170
91725165|NCT00845182|183344830|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
91725166|NCT00845182|183344830|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91725167|NCT04621760|183344833|SUPERIORITY|||||||0.51||||||a priori threshold for statistical significance: 0.05|Fisher Exact|||||||0.51
91725168|NCT04621760|183344834|SUPERIORITY|||||||0.62||||||threshold for significance: 0.05|Fisher Exact|one sided Fisher's exct test, given small cell sizes.||||||0.62
91725169|NCT04621760|183344835|SUPERIORITY|||||||0.207||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small sample size||||||0.207
91725170|NCT04621760|183344836|SUPERIORITY|||||||0.496||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.496
91490180|NCT02468674|182852877|OTHER|||||||0.395|||||||ANCOVA|Difference in the least square means (SE)||Population II: Gait speed at Week 49||||0.395
91725171|NCT04621760|183344837|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly identifying PrEP is a daily pill to prevent HIV"||||0.02
91725172|NCT04621760|183344837|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly responding to prompt: PrEP is for all adults"||||0.01
91725173|NCT04621760|183344837|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified: PrEP will not work if taken once a week"||||<0.01
91725174|NCT04621760|183344837|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test of proportion who correctly identified PrEP does not prevent STDs other than HIV"||||<0.01
91725175|NCT04621760|183344837|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, PrEP side effects do not last forever"||||<0.01
91725176|NCT04621760|183344837|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, A baby could be norm to HIV discordant parents without transmitting HIV"||||0.03
91725177|NCT04621760|183344837|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified There is medication you can take after sex to prevent HIV"||||<0.01
91725178|NCT04621760|183344837|SUPERIORITY|||||||0.29||||||a priori threshold for significance: 0.05|Chi-squared|||"Test for proportion who correctly identified PrEP efficacy is \> 95%"||||0.29
91490181|NCT02468674|182852878|OTHER|||||||0.12|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.120
91490182|NCT02468674|182852878|OTHER|||||||0.297|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.297
91490183|NCT02468674|182852878|OTHER|||||||0.074|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.074
91490184|NCT02468674|182852878|OTHER|||||||0.022|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.022
91725179|NCT04621760|183344838|SUPERIORITY|||||||0.04||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.04
91725180|NCT04621760|183344839|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.02
91725181|NCT04621760|183344840|SUPERIORITY|||||||0.05||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.05
91725182|NCT04621760|183344841|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.03
91725183|NCT04621760|183344842|SUPERIORITY|||||||0.07||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.07
91725184|NCT04621760|183344843|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.10
91725185|NCT04621760|183344844|SUPERIORITY|||||||0.22||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.||||0.22
91725186|NCT04621760|183344845|SUPERIORITY|||||||0.51||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.51
91725187|NCT04621760|183344846|SUPERIORITY|||||||0.9||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PrEP||||0.90
91725188|NCT04621760|183344846|SUPERIORITY|||||||0.75||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use abstinence||||0.75
91725189|NCT04621760|183344846|SUPERIORITY|||||||0.32||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PEP||||0.32
91725190|NCT04621760|183344846|SUPERIORITY|||||||0.4||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use HIV testing||||0.40
91725191|NCT04621760|183344846|SUPERIORITY|||||||0.34||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use STD testing||||0.34
91725192|NCT04621760|183344846|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use Treatment as Prevention||||0.10
91725193|NCT04621760|183344847|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||||||0.01
91725194|NCT04621760|183344848|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt The information was easy to understand"||||0.26
91725195|NCT04621760|183344848|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: I got all of the information I needed"||||0.26
91725196|NCT04621760|183344848|SUPERIORITY|||||||0.59||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.59
91725197|NCT04621760|183344848|SUPERIORITY|||||||0.17||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: The information felt useful to me"||||0.17
91725198|NCT04621760|183344849|SUPERIORITY|||||||0.74|||||||Chi-squared|||"Testing proportion of acceptability of abstinence method (proportion that responded great for me)"||||0.74
91725199|NCT04621760|183344849|SUPERIORITY|||||||0.59|||||||Chi-squared|||"Testing proportion of acceptability of condoms method (proportion that responded great for me)"||||0.59
91725200|NCT04621760|183344849|SUPERIORITY|||||||0.66|||||||Chi-squared|||"Testing proportion of acceptability of PEP method (proportion that responded great for me)"||||0.66
91725201|NCT04621760|183344849|SUPERIORITY|||||||0.49|||||||Chi-squared|||"Testing proportion of acceptability of PrEP method (proportion that responded great for me)"||||0.49
91725202|NCT04621760|183344849|SUPERIORITY|||||||0.94|||||||Chi-squared|||"Testing proportion of acceptability of HIV testing method (proportion that responded great for me)"||||0.94
91725203|NCT04621760|183344849|SUPERIORITY|||||||0.95|||||||Chi-squared|||"Testing proportion of acceptability of STD testing method (proportion that responded great for me)"||||0.95
91725204|NCT04621760|183344849|SUPERIORITY|||||||0.39|||||||Chi-squared|||"Testing proportion of acceptability of Treatment as prevention method (proportion that responded great for me)"||||0.39
91725205|NCT04621760|183344855|SUPERIORITY|||||||0.13||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.13
91725206|NCT04621760|183344856|SUPERIORITY|||||||0.08||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.08
91725207|NCT01028560|183344858|OTHER||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis||The above is the slope for immunotherapy group . The (quadratic) slope is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with a median score values.||0.63|-0.24|0.38
91725208|NCT01028560|183344858|OTHER||Slope|0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|0.11|0.99|||Mixed Models Analysis|The above (quadratic) slope is for control group|The above is the (quadratic) slope is for control group and is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with median score values.||0.99|0.11|0.013
91490185|NCT02468674|182852878|OTHER|||||||0.106|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.106
91490186|NCT02468674|182852878|OTHER|||||||0.211|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.211
91725209|NCT01028560|183344858|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|4.97||0.978|TWO_SIDED|95.0|-11.76|12.03||Post estimation means were tested between the intervention arms after LME model at year 1 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.03|-11.76|0.978
91725210|NCT01028560|183344858|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|5.89||0.77|TWO_SIDED|95.0|-15.83|12.38||Post estimation means were tested between the intervention arms after LME model at year 2 and the p- value was unadjusted p value|contrast testing post mixed model]||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.38|-15.83|0.77
91725211|NCT01028560|183344858|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|7.39||0.8|TWO_SIDED|95.0|-19.54|15.84||Post estimation means were tested between the intervention arms after LME model at year 3 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||15.84|-19.54|0.80
91725212|NCT01028560|183344859|SUPERIORITY|||||||0.677||||||Chi-square test (proportion of new sensitizations versus unchanged or lost sensitizations in each group, intention-to treat analysis).|Chi-squared|||||||0.677
91725213|NCT01028560|183344860|SUPERIORITY||Slope|0.56||||0.546|TWO_SIDED|95.0|-2.18|3.29||Test of parallelism (group x time) hypothesis P-value.|covariance pattern (rep. measure) model|Within group difference p-values ( baseline vs 3-years) in control and intervention arm were 0.56 and 0.20 respectively.|The estimated slope reported is for year 3 from the covariance pattern model with autoregressive covariance structure.|Covariance Pattern Model with autoregressive covariance structure with REML (Restricted Estimation of Maximum Likelihood) with time and role as categorical variable was modeled.||3.29|-2.18|0.5460
91725214|NCT01028560|183344861|SUPERIORITY||Rate ratio|1.27||||0.289|TWO_SIDED|95.0|0.82|1.96||Poisson regression model for treatment arm adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst and the time period contributed by each child in years were fitted as offset.|Poisson regression|Poisson regression model with robust variance with contributed person years used as offset was modeled.||Null hypothesis = Incidence rate of CSB in each group are same. Poisson regression adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst.||1.96|0.82|0.289
91725215|NCT01960842|183344864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.78|-3.5|||One-sample t-test, 2-sided|||||-3.50|-5.78|<0.001
91490187|NCT02468674|182852879|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: ASMI at Week 49||||1.000
91490188|NCT02468674|182852880|OTHER|||||||0.084|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.084
91490189|NCT02468674|182852880|OTHER|||||||0.283|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.283
91528130|NCT01614847|182931501|EQUIVALENCE|two-tailed, alpha = 0.05||||||0.109|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.109
91725216|NCT01960842|183344865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.58|||<|0.001|TWO_SIDED|95.0|4.21|6.95|||One-sample t-test, 2-sided|||||6.95|4.21|<0.001
91490190|NCT02468674|182852880|OTHER|||||||0.323|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.323
91725217|NCT01960842|183344866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0|||<|0.001|TWO_SIDED|95.0|-16.3|-7.7|||One-sample t-test, 2-sided|||||-7.7|-16.3|<0.001
91490191|NCT02468674|182852880|OTHER|||||||0.018|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.018
91490192|NCT02468674|182852880|OTHER|||||||0.179|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.179
91725218|NCT01960842|183344867|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.1|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
91725219|NCT01960842|183344868|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.0|STANDARD_DEVIATION|0.94|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
91725220|NCT01960842|183344869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|||=|0.101|TWO_SIDED|95.0|-4.0|0.4|||One-sample t-test, 2-sided|||||0.4|-4.0|=0.101
91725221|NCT01960842|183344870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||=|0.182|TWO_SIDED|95.0|-5.3|1.1|||One-sample t-test, 2-sided|||||1.1|-5.3|=0.182
91725222|NCT01960842|183344871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.9|-0.09|||One-sample t-test, 2-sided|||||-0.09|-1.90|=0.032
91490193|NCT02468674|182852880|OTHER|||||||0.227|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.227
91490194|NCT02468674|182852881|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: LBM at Week 49||||1.000
91490195|NCT01650844|182852894|OTHER|We estimated the power to detect the smallest clinically significant difference in mean SFDs post intervention between the groups, accounting for repeated measures. A sample of 400 obtains greater than 90% power to detect a difference of 0.8 SFD per 2 weeks or greater. Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.8|<|0.05|TWO_SIDED|||||Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Regression, Linear|||||||<0.05
91490196|NCT01332500|182852895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan tablets|paired t-test 2-sided|||||||<0.001
91490197|NCT01332500|182852895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||<0.001
91490198|NCT01332500|182852895|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.005
91490199|NCT01332500|182852895|SUPERIORITY_OR_OTHER|||||||0.336||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.336
91490200|NCT01332500|182852895|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||Other tablets|paired t-test 2-sided|||||||0.162
91528131|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.779|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.779
91725223|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.2|||<|0.001|TWO_SIDED|95.0|-27.8|-10.6|||One-sample t-test, 2-sided|||Mobility Domain analysis.||-10.6|-27.8|<0.001
91725224|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|||=|0.059|TWO_SIDED|95.0|-13.3|0.3|||One-sample t-test, 2-sided|||Emotional Well-Being Domain analysis.||0.3|-13.3|=0.059
91725225|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|||=|0.07|TWO_SIDED|95.0|-15.6|0.6|||One-sample t-test, 2-sided|||Stigma Domain analysis.||0.6|-15.6|=0.070
91725226|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|||=|0.591|TWO_SIDED|95.0|-7.3|4.2|||One-sample t-test, 2-sided|||Social Support Domain analysis.||4.2|-7.3|=0.591
91490201|NCT01332500|182852896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
91490202|NCT01332500|182852896|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.349
91490203|NCT01332500|182852896|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.208
91725227|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.7|-7.3|||One-sample t-test, 2-sided|||Cognition Domain analysis.||-7.3|-20.7|<0.001
91725228|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||=|0.67|TWO_SIDED|95.0|-4.2|6.4|||One-sample t-test, 2-sided|||Communication Domain analysis.||6.4|-4.2|=0.670
91725229|NCT01960842|183344872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|||<|0.001|TWO_SIDED|95.0|-25.2|-10.3|||One-sample t-test, 2-sided|||Bodily Discomfort Domain analysis.||-10.3|-25.2|<0.001
91725230|NCT01960842|183344873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||=|0.056|TWO_SIDED|95.0|-9.8|0.1|||One-sample t-test, 2-sided|||||0.1|-9.8|=0.056
91725231|NCT01960842|183344874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||=|0.011|TWO_SIDED|95.0|-1.6|-0.2|||One-sample t-test, 2-sided|||||-0.2|-1.6|=0.011
91725232|NCT01960842|183344875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-1.9|||One-sample t-test, 2-sided|||||-1.9|-4.4|<0.001
91725233|NCT01960842|183344876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.65|||<|0.001|TWO_SIDED|95.0|-5.83|-3.47|||One-sample t-test, 2-sided|||||-3.47|-5.83|<0.001
91725234|NCT01960842|183344877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.58|||<|0.001|TWO_SIDED|95.0|-5.73|-3.44|||One-sample t-test, 2-sided|||||-3.44|-5.73|<0.001
91725235|NCT00896233|183344931|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.81|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.81|
91725236|NCT00896233|183344931|SUPERIORITY_OR_OTHER||ICC|0.85|||||TWO_SIDED|90.0|0.71|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.98|0.71|
91725237|NCT00896233|183344931|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.78|
91725238|NCT00896233|183344931|SUPERIORITY_OR_OTHER||ICC|0.86|||||TWO_SIDED|90.0|0.75|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.75|
91725239|NCT00896233|183344932|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.8|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.80|
91725240|NCT00896233|183344932|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.78|
91725241|NCT00896233|183344932|SUPERIORITY_OR_OTHER||ICC|0.93|||||TWO_SIDED|90.0|0.87|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.87|
91725242|NCT00896233|183344932|SUPERIORITY_OR_OTHER||ICC|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.88|
91725243|NCT02697422|183344935|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725244|NCT02697422|183344936|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725245|NCT02697422|183344937|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725246|NCT02697422|183344938|SUPERIORITY|||||||0.9|TWO_SIDED|95.0||||Smoker/tobacco use results were calculated using logistic regression.|Regression, Logistic|||Smoker/tobacco use results were calculated using logistic regression. A P value of .90 was found comparing smoking/tobacco use in intervention vs control participants. A difference was not reported between intervention and control because smoking/ tobacco use was a binary variable.||||0.90
91725247|NCT02697422|183344939|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725248|NCT02697422|183344940|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725249|NCT02697422|183344941|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725250|NCT02697422|183344942|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725251|NCT02697422|183344943|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91725252|NCT02697422|183344944|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
91490204|NCT01332500|182852896|SUPERIORITY_OR_OTHER|||||||0.239||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.239
91490205|NCT01332500|182852896|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.583
91490206|NCT01332500|182852896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total heath plan costs|paired t-test 2-sided|||||||<0.001
91490207|NCT01332500|182852897|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
91490208|NCT01332500|182852897|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Non-steroidal, anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.177
91725253|NCT02068599|183344946|SUPERIORITY||LSM difference from placebo|4.26||||0.1213|TWO_SIDED|95.0|-1.13|9.66||5% level of significance|mixed model for repeated measures|||LSM = least square mean||9.66|-1.13|0.1213
91725254|NCT02068599|183344946|SUPERIORITY||LSM difference from placebo|1.74||||0.5231|TWO_SIDED|95.0|-3.62|7.11||5% level of significance|mixed model for repeated measures|||LSM = least square mean||7.11|-3.62|0.5231
91725255|NCT02068599|183344947|SUPERIORITY||LSM difference from placebo|17.86||||0.1795|TWO_SIDED|95.0|-8.26|43.98||5% level of significance|mixed model for repeated measures|||LSM = least square mean||43.98|-8.26|0.1795
91725256|NCT02068599|183344947|SUPERIORITY||LSM difference from placebo|9.0||||0.4956|TWO_SIDED|95.0|-16.95|34.96||5% level of significance|mixed model for repeated measures|||LSM = least square mean||34.96|-16.95|0.4956
91725257|NCT02068599|183344948|SUPERIORITY||LSM difference from placebo|3.61||||0.1963|TWO_SIDED|95.0|-1.87|9.08||5% level of significance|mixed model for repeated measures|||||9.08|-1.87|0.1963
91725258|NCT02068599|183344948|SUPERIORITY||LSM difference from placebo|2.06||||0.4584|TWO_SIDED|95.0|-3.39|7.5||5% level of significance|mixed model for repeated measures|||||7.50|-3.39|0.4584
91725259|NCT02068599|183344949|SUPERIORITY||LSM difference from placebo|23.51||||0.642|TWO_SIDED|95.0|-75.83|122.84||5% level of significance|mixed model for repeated measures|||||122.84|-75.83|0.6420
91725260|NCT02068599|183344949|SUPERIORITY||LSM difference from placebo|-50.4||||0.3141|TWO_SIDED|95.0|-148.72|47.92||5% level of significance|mixed model for repeated measures|||||47.92|-148.72|0.3141
91725261|NCT02068599|183344950|SUPERIORITY||LSM difference from placebo|3.16||||0.6184|TWO_SIDED|95.0|-9.31|15.63||5% level of significance|mixed model for repeated measures|||||15.63|-9.31|0.6184
91725262|NCT02068599|183344950|SUPERIORITY||LSM difference from placebo|-3.48||||0.5775|TWO_SIDED|95.0|-15.78|8.81||5% level of significance|mixed model for repeated measures|||||8.81|-15.78|0.5775
91725263|NCT02068599|183344951|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1011|TWO_SIDED|95.0|0.345|1.099||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.099|0.345|0.1011
91725264|NCT02068599|183344951|SUPERIORITY||Odds Ratio (OR)|1.06||||0.84|TWO_SIDED|95.0|0.615|1.819||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.819|0.615|0.8400
91725265|NCT02068599|183344951|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6607|TWO_SIDED|95.0|0.531|1.494||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.494|0.531|0.6607
91725266|NCT02068599|183344951|SUPERIORITY||Odds Ratio (OR)|0.87||||0.5777|TWO_SIDED|95.0|0.52|1.441||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.441|0.520|0.5777
91725267|NCT02068599|183344952|SUPERIORITY||LSM difference from placebo|3.94||||0.4316|TWO_SIDED|95.0|-5.9|13.79||5% level of significance|mixed model for repeated measures|||||13.79|-5.90|0.4316
91725268|NCT02068599|183344952|SUPERIORITY||LSM difference from placebo|2.51||||0.6126|TWO_SIDED|95.0|-7.24|12.26||5% level of significance|mixed model for repeated measures|||||12.26|-7.24|0.6126
91725269|NCT02068599|183344953|SUPERIORITY||LSM difference from placebo|0.01||||0.9208|TWO_SIDED|95.0|-0.232|0.257||5% level of significance|mixed model for repeated measures|||Week 2||0.257|-0.232|0.9208
91528132|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.262|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.262
91490209|NCT01332500|182852897|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.173
91490210|NCT01332500|182852897|SUPERIORITY_OR_OTHER|||||||0.191||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.191
91725270|NCT02068599|183344953|SUPERIORITY||LSM difference from placebo|0.04||||0.7344|TWO_SIDED|95.0|-0.2|0.284||5% level of significance|mixed model for repeated measures|||Week 2||0.284|-0.200|0.7344
91725271|NCT02068599|183344953|SUPERIORITY||LSM difference from placebo|0.21||||0.1199|TWO_SIDED|95.0|-0.056|0.486||5% level of significance|mixed model for repeated measures|||Week 4||0.486|-0.056|0.1199
91490211|NCT01332500|182852897|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.254
91490212|NCT01332500|182852897|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||<0.001
91725272|NCT02068599|183344953|SUPERIORITY||LSM difference from placebo|0.06||||0.6357|TWO_SIDED|95.0|-0.204|0.334||5% level of significance|mixed model for repeated measures|||Week 4||0.334|-0.204|0.6357
91725273|NCT02068599|183344954|SUPERIORITY||LSM difference from placebo|2.77||||0.2906|TWO_SIDED|95.0|-2.377|7.916||5% level of significance|mixed model for repeated measures|||Week 2||7.916|-2.377|0.2906
91725274|NCT02068599|183344954|SUPERIORITY||LSM difference from placebo|1.41||||0.5892|TWO_SIDED|95.0|-3.707|6.518||5% level of significance|mixed model for repeated measures|||Week 2||6.518|-3.707|0.5892
91725275|NCT02068599|183344954|SUPERIORITY||LSM difference from placebo|0.82||||0.7699|TWO_SIDED|95.0|-4.678|6.315||5% level of significance|mixed model for repeated measures|||Week 4||6.315|-4.678|0.7699
91725276|NCT02068599|183344954|SUPERIORITY||LSM difference from placebo|1.74||||0.532|TWO_SIDED|95.0|-3.721|7.193||5% level of significance|mixed model for repeated measures|||Week 4||7.193|-3.721|0.5320
91725277|NCT02068599|183344955|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5358|TWO_SIDED|95.0|0.501|1.433||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||1.433|0.501|0.5358
91490213|NCT01332500|182852898|SUPERIORITY_OR_OTHER|||||||0.866||95.0||||Triptan tablets|paired t-test 2-sided|||||||0.866
91490214|NCT01332500|182852898|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||0.094
91725278|NCT02068599|183344955|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1532|TWO_SIDED|95.0|0.87|2.423||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||2.423|0.870|0.1532
91725279|NCT03019588|183344962|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.29|TWO_SIDED|95.0|0.58|1.36|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||1.36|0.58|0.2900
91725280|NCT03019588|183344963|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.9954|TWO_SIDED|95.0|1.14|2.74|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||2.74|1.14|0.9954
91725281|NCT03019588|183344964|SUPERIORITY||Difference in percentage|-6.0||||0.7884|TWO_SIDED|95.0|-21.6|9.3|||Z-test|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||9.3|-21.6|0.7884
91725282|NCT00106535|183344968|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91725283|NCT00106535|183344968|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91725284|NCT00106535|183344969|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91725285|NCT00106535|183344969|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91725286|NCT00106535|183344970|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91490215|NCT01332500|182852898|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.832
91490216|NCT01332500|182852898|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.392
91490217|NCT01332500|182852898|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Other tablets|paired t-test 2-sided|||||||0.752
91725287|NCT00106535|183344970|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91725288|NCT00106535|183344979|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
91725289|NCT00106535|183344979|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
91725290|NCT00106535|183344980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.26|||<|0.0001|TWO_SIDED|95.0|-96.96|-43.56|||ANOVA|Adjusted for region and original treatment group.||||-43.56|-96.96|<0.0001
91725291|NCT00106535|183344980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.95|||<|0.0001|TWO_SIDED|95.0|-112.69|-59.22|||ANOVA|Adjusted for region and original treatment group.||||-59.22|-112.69|<0.0001
91725292|NCT00106535|183344982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.1|||<|0.0001|TWO_SIDED|95.0|-205.22|-90.98|||ANOVA|Adjusted for region.||||-90.98|-205.22|<0.0001
91725293|NCT00106535|183344982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-181.4|||<|0.0001|TWO_SIDED|95.0|-238.6|-124.21|||ANOVA|Adjusted for region.||||-124.21|-238.60|<0.0001
91725294|NCT00106535|183345007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5212.28|||<|0.0001|TWO_SIDED|95.0|3139.4|7285.16|||ANOVA|Adjusted for region.||||7285.16|3139.40|<0.0001
91725295|NCT00106535|183345007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7092.76|||<|0.0001|TWO_SIDED|95.0|5066.16|9119.36||Adjusted for region.|ANOVA|||||9119.36|5066.16|<0.0001
91725296|NCT00106535|183345023|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Van Elteren's test|Stratified by region.||||||0.0023
91725297|NCT00106535|183345023|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|||||||<0.0001
91725298|NCT00106535|183345024|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||0.0001
91725299|NCT00106535|183345024|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
91725300|NCT06042855|183345080|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.89|1.03|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.03|0.89|
91725301|NCT06042855|183345081|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.32|6.38||||||No hypothesis test or decision rule was evaluated.||6.38|0.32|
91725302|NCT06042855|183345084|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.82|1.78|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.78|0.82|
91725303|NCT06042855|183345085|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.66|1.31|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.31|0.66|
91725304|NCT06042855|183345086|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.57|1.41|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.41|0.57|
91725305|NCT06042855|183345087|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.78|1.42|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.42|0.78|
91725306|NCT06042855|183345088|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Day 7||1.32|0.85|
91725307|NCT06042855|183345088|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||Day 14||1.28|0.85|
91725308|NCT06042855|183345088|OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.94|1.53||||||Day 28||1.53|0.94|
91725309|NCT06042855|183345088|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||Day 90||1.48|0.91|
91490218|NCT01332500|182852899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
91490219|NCT01332500|182852899|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.054
91490220|NCT01332500|182852899|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.590
91490221|NCT01332500|182852899|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.382
91725310|NCT06042855|183345088|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.06|1.77||||||Day 120||1.77|1.06|
91725311|NCT06042855|183345088|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|1.02|1.66||||||Day 180||1.66|1.02|
91725312|NCT06042855|183345089|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.86|1.15||||||Day 7||1.15|0.86|
91725313|NCT06042855|183345089|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.87|1.21||||||Day 14||1.21|0.87|
91725314|NCT06042855|183345089|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.58|0.92||||||Day 28||0.92|0.58|
91725315|NCT06042855|183345089|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.7|1.02||||||Day 90||1.02|0.70|
91490222|NCT01332500|182852899|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.343
91725316|NCT06042855|183345089|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.68|0.99||||||Day 120||0.99|0.68|
91725317|NCT06042855|183345089|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||Day 180||1.01|0.70|
91725318|NCT06042855|183345090|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.7|1.06||||||Day 7||1.06|0.70|
91725319|NCT06042855|183345090|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.79|1.14||||||Day 14||1.14|0.79|
91725320|NCT06042855|183345090|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.69|1.1||||||Day 28||1.10|0.69|
91725321|NCT06042855|183345090|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.8|1.25||||||Day 90||1.25|0.80|
91725322|NCT06042855|183345090|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.7|1.08||||||Day 120||1.08|0.70|
91725323|NCT06042855|183345090|OTHER||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.66|1.04||||||Day 180||1.04|0.66|
91725324|NCT06042855|183345091|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.7|1.09||||||Day 7||1.09|0.70|
91725325|NCT06042855|183345091|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.65|0.98||||||Day 14||0.98|0.65|
91725326|NCT06042855|183345091|OTHER||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.47|0.85||||||Day 28||0.85|0.47|
91725327|NCT06042855|183345091|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.7|1.08||||||Day 90||1.08|0.70|
91725328|NCT06042855|183345091|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.62|0.96||||||Day 120||0.96|0.62|
91725329|NCT06042855|183345091|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.61|0.95||||||Day 180||0.95|0.61|
91725330|NCT06042855|183345092|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.83|1.22||||||Day 7||1.22|0.83|
91725331|NCT06042855|183345092|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.76|1.13||||||Day 14||1.13|0.76|
91725332|NCT06042855|183345092|OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.45|0.8||||||Day 28||0.80|0.45|
91725333|NCT06042855|183345092|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.59|0.9||||||Day 90||0.90|0.59|
91725334|NCT06042855|183345092|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.97||||||Day 120||0.97|0.61|
91725335|NCT06042855|183345092|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.62|0.94||||||Day 180||0.94|0.62|
91725336|NCT06042855|183345093|OTHER||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.95|1.43||||||Day 7||1.43|0.95|
91725337|NCT06042855|183345093|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.87|1.25||||||Day 14||1.25|0.87|
91725338|NCT06042855|183345093|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.99|1.59||||||Day 28||1.59|0.99|
91490223|NCT01332500|182852899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plan costs|paired t-test 2-sided|||||||<0.001
91725339|NCT06042855|183345093|OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.89|1.35||||||Day 90||1.35|0.89|
91725340|NCT06042855|183345093|OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.98|1.48||||||Day 120||1.48|0.98|
91725341|NCT06042855|183345093|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.96|1.46||||||Day 180||1.46|0.96|
91725342|NCT06042855|183345094|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||Day 7||1.26|0.96|
91725343|NCT06042855|183345094|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||Day 14||1.14|0.87|
91725344|NCT06042855|183345094|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||Day 28||1.07|0.81|
91725345|NCT06042855|183345094|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.76|1.07||||||Day 90||1.07|0.76|
91490224|NCT01332500|182852900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
91490225|NCT01332500|182852900|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Non-steroidal anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.146
91490226|NCT01332500|182852900|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.826
91490227|NCT01332500|182852900|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.354
91490228|NCT01332500|182852900|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.514
91490229|NCT01332500|182852900|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||0.001
91725346|NCT06042855|183345094|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.78|1.06||||||Day 120||1.06|0.78|
91725347|NCT06042855|183345094|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.75|1.04||||||Day 180||1.04|0.75|
91725348|NCT06042855|183345095|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.28|-0.21|
91725349|NCT06042855|183345096|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.26|-0.34|
91725350|NCT06100250|183345118|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|0.82||||0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 66|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0||||0.01
91725351|NCT06100250|183345120|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|-1.29|||<|0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 47|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0||||<0.01
91725352|NCT05259033|183345130|SUPERIORITY|Responses were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Estimated treatment difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.33|||ANCOVA|||Treatment policy strategy||-0.33|-0.56|<0.0001
91725353|NCT05537571|183345136|SUPERIORITY||Mean Difference (Final Values)|-82.8|||<|0.0001|TWO_SIDED|95.0|-88.19|-77.39|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.39|-88.19|<0.0001
91725354|NCT05537571|183345136|SUPERIORITY||Mean Difference (Final Values)|-81.3|||<|0.0001|TWO_SIDED|95.0|-86.68|-76.0|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-76.0|-86.68|<0.0001
91725355|NCT05537571|183345136|SUPERIORITY||Mean Difference (Final Values)|-85.6|||<|0.0001|TWO_SIDED|95.0|-90.88|-80.26|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-80.26|-90.88|<0.0001
91725356|NCT05537571|183345137|SUPERIORITY||Mean Difference (Final Values)|-83.1|||<|0.0001|TWO_SIDED|95.0|-88.7|-77.57|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.57|-88.7|<0.0001
91725357|NCT05537571|183345137|SUPERIORITY||Mean Difference (Final Values)|-78.7|||<|0.0001|TWO_SIDED|95.0|-84.18|-73.17|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.17|-84.18|<0.0001
91490230|NCT01687998|182852901|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.006||||0.9054|TWO_SIDED|95.0|0.911|1.111|||Regression, Cox|||Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)||1.111|0.911|0.9054
91528133|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.150
91528134|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.726|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.726
91725358|NCT05537571|183345137|SUPERIORITY||Mean Difference (Final Values)|-83.0|||<|0.0001|TWO_SIDED|95.0|-88.43|-77.49|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.49|-88.43|<0.0001
91725359|NCT05537571|183345138|SUPERIORITY||Mean Difference (Final Values)|-79.2|||<|0.0001|TWO_SIDED|95.0|-85.25|-73.1|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.1|-85.25|<0.0001
91725360|NCT05537571|183345138|SUPERIORITY||Mean Difference (Final Values)|-71.8|||<|0.0001|TWO_SIDED|95.0|-77.81|-65.8|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-65.8|-77.81|<0.0001
91725361|NCT05537571|183345138|SUPERIORITY||Mean Difference (Final Values)|-77.1|||<|0.0001|TWO_SIDED|95.0|-83.09|-71.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-71.15|-83.09|<0.0001
91490231|NCT01687998|182852902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.11|||<|0.0001|TWO_SIDED|95.0|-38.15|-36.08|||ANOVA|||LDL-C||-36.08|-38.15|<0.0001
91528135|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.055|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.055
91490232|NCT01687998|182852902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|131.55|||<|0.0001|TWO_SIDED|95.0|130.01|133.09|||ANOVA|||HDL-C||133.09|130.01|<0.0001
91528136|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
91528137|NCT01614847|182931501|EQUIVALENCE|Alpha = 0.05||||||0.844|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.844
91528138|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945||||||df=7|Wilcoxon (Mann-Whitney)|||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
91725362|NCT05537571|183345139|SUPERIORITY||Mean Difference (Final Values)|-13.3|||<|0.0001|TWO_SIDED|95.0|-18.55|-8.09|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.09|-18.55|<0.0001
91725363|NCT05537571|183345139|SUPERIORITY||Mean Difference (Final Values)|-9.9|||=|0.0002|TWO_SIDED|95.0|-15.02|-4.68|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.68|-15.02|=0.0002
91725364|NCT05537571|183345139|SUPERIORITY||Mean Difference (Final Values)|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.1|-9.82|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.82|-20.1|<0.0001
91725365|NCT05537571|183345140|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.62|-7.08|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.08|-17.62|<0.0001
91490233|NCT01687998|182852903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.991||||0.8463|TWO_SIDED|95.0|0.901|1.089|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA||1.089|0.901|0.8463
91528139|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383||||||Alpha = 0.05|Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.383
91528140|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383|||||||Wilcoxon (Mann-Whitney)|df=7||Mean change in osmolarity from baseline. H0: No change (e.g. mean change = 0) H1: Significant change (mean change ≠ 0)||||0.383
91528141|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.672|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.672
91528142|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.107|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.107
91725366|NCT05537571|183345140|SUPERIORITY||Mean Difference (Final Values)|-8.6|||=|0.0013|TWO_SIDED|95.0|-13.85|-3.44|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.44|-13.85|=0.0013
91725367|NCT05537571|183345140|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.2|-8.84|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.84|-19.2|<0.0001
91725368|NCT05537571|183345141|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.81|-5.73|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-5.73|-16.81|<0.0001
91725369|NCT05537571|183345141|SUPERIORITY||Mean Difference (Final Values)|-7.2|||=|0.0106|TWO_SIDED|95.0|-12.64|-1.69|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-1.69|-12.64|=0.0106
91725370|NCT05537571|183345141|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.04|-7.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.15|-18.04|<0.0001
91725371|NCT05537571|183345142|SUPERIORITY||Mean Difference (Final Values)|-31.9|||=|0.0051|TWO_SIDED|95.0|-54.07|-9.72|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.72|-54.07|=0.0051
91725372|NCT05537571|183345142|SUPERIORITY||Mean Difference (Final Values)|-29.7|||=|0.0081|TWO_SIDED|95.0|-51.62|-7.81|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.81|-51.62|=0.0081
91725373|NCT05537571|183345142|SUPERIORITY||Mean Difference (Final Values)|-25.1|||=|0.0241|TWO_SIDED|95.0|-46.89|-3.33|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.33|-46.89|=0.0241
91725374|NCT05537571|183345143|SUPERIORITY||Mean Difference (Final Values)|-29.8|||=|0.0023|TWO_SIDED|95.0|-48.86|-10.76|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-10.76|-48.86|=0.0023
91725375|NCT05537571|183345143|SUPERIORITY||Mean Difference (Final Values)|-27.4|||=|0.0046|TWO_SIDED|95.0|-46.23|-8.58|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.58|-46.23|=0.0046
91725376|NCT05537571|183345143|SUPERIORITY||Mean Difference (Final Values)|-26.0|||=|0.0068|TWO_SIDED|95.0|-44.67|-7.24|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.24|-44.67|=0.0068
91725377|NCT05537571|183345144|SUPERIORITY||Mean Difference (Final Values)|-28.7|||=|0.0057|TWO_SIDED|95.0|-48.91|-8.46|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.46|-48.91|=0.0057
91528143|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.64|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.64
91528144|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.04|||||||Wilcoxon (Mann-Whitney)|df=14||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.040
91725378|NCT05537571|183345144|SUPERIORITY||Mean Difference (Final Values)|-26.1|||||TWO_SIDED|95.0|-46.13|-6.16||||||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-6.16|-46.13|
91725379|NCT05537571|183345144|SUPERIORITY||Mean Difference (Final Values)|-24.1||||0.0179|TWO_SIDED|95.0|-43.93|-4.2|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.2|-43.93|0.0179
91725380|NCT03837938|183345158|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%.|Difference in rates Levopront®-Libexin®|5.81|||||ONE_SIDED|97.5|-7.17|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.17|
91725381|NCT03837938|183345159|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%|difference in rates Levopront®-Libexin®|5.43|||||ONE_SIDED|97.5|-7.31|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.31|
91725382|NCT03837938|183345160|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||>|0.999|||||||Fisher Exact|||||||>0.999
91725383|NCT03837938|183345161|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||=|0.861|||||||Fisher Exact|||||||=0.861
91725384|NCT03837938|183345162|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 2, Day 4||||<0.001
91528145|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.2|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.20
91725385|NCT03837938|183345162|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 2 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 3, Day 8||||<0.001
91725386|NCT03837938|183345162|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nightime at Visit 2, Day 4||||<0.001
91725387|NCT03837938|183345162|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nighttime at Visit 3, Day 8||||<0.001
91528146|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df-=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.150
91725388|NCT03837938|183345163|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Visit 2, Day 4||||<0.001
91725389|NCT03837938|183345163|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||at Visit 3, Day 8||||<0.001
91725390|NCT03837938|183345164|NON_INFERIORITY|non-inferiority margin is defined as 20%|||||=|0.336|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||||||=0.336
91725391|NCT06394323|183345176|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.74||0.2157|TWO_SIDED|95.0|-8.9|1.9||The a priori threshold for statistical significance is p\<0.05.|Welch's t test, 2 sided|The Welch's t test statistic was -1.25 and the degrees of freedom were 84.67.|The mean difference was calculated by subtracting the mean DCS of the SOC arm from the mean DCS of the MyChoice intervention arm (MyChoice mean - SOC mean).|The null hypothesis is that the mean DCS for the MyChoice and SOC arms are equal.||1.9|-8.9|0.2157
91725392|NCT01501513|183345190|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91725393|NCT05675020|183345194|OTHER|The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0. We analyzed the percentage of correct responses for knowledge survey questions from pre- and post-intervention survey responses.|||||||||||||||||Participant data was collected from the REDCap pre- and post-intervention questionnaires completed by the adolescents and parents/legal guardians that participated in the project. Data was collected from October to December 2022. The sample size was nine parent-adolescent dyads. Descriptive analysis was used to assess differences in sociodemographic variables, including age, gender, race, material status, employment status, salary, height, and weight. The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0.|||
91725394|NCT01778985|183345201|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
91725395|NCT01778985|183345202|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
91725396|NCT01778985|183345203|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
91725397|NCT01778985|183345204|SUPERIORITY_OR_OTHER|||||||0.088|||||||t-test, 2 sided|t(18)=1.78, p=0.088||||||0.088
91528147|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.73|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.730
91725398|NCT01778985|183345205|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91725399|NCT01778985|183345206|SUPERIORITY_OR_OTHER|||||||0.91||||||t(28)=0.11, p=0.91|t-test, 2 sided|||||||0.91
91725400|NCT01778985|183345207|SUPERIORITY_OR_OTHER|||||||0.1||||||t(18)=1.69, p=.10|t-test, 2 sided|||||||0.10
91725401|NCT01778985|183345208|SUPERIORITY_OR_OTHER|||||||0.02||||||t(10)=2.76, p=0.020|t-test, 2 sided|||||||0.020
91725402|NCT01778985|183345209|SUPERIORITY_OR_OTHER|||||||0.78||||||t(23)=0.28, p=0.78|t-test, 2 sided|||||||0.78
91725403|NCT01778985|183345210|SUPERIORITY_OR_OTHER|||||||0.51||||||t(28)=0.67, p=0.51|t-test, 2 sided|||||||0.51
91725404|NCT01778985|183345211|SUPERIORITY_OR_OTHER|||||||0.24||||||t(23)=1.23, p=0.24|t-test, 2 sided|||||||0.24
91725405|NCT01778985|183345212|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
91725406|NCT01778985|183345213|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
91725407|NCT01778985|183345214|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91528148|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
91725408|NCT01778985|183345215|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
91725409|NCT01778985|183345216|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
91725410|NCT01778985|183345217|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
91725411|NCT01778985|183345218|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
91725412|NCT01778985|183345219|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
91725413|NCT01778985|183345220|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1
91725414|NCT05788328|183345225|OTHER||Ratio of Adjusted Geometric Means|86.5|||||TWO_SIDED|90.0|66.05|113.29|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||113.29|66.05|
91725415|NCT05788328|183345225|OTHER||Ratio of Adjusted Geometric Means|82.64|||||TWO_SIDED|90.0|63.1|108.24|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||108.24|63.10|
91725416|NCT05788328|183345226|OTHER||Ratio of Adjusted Geometric Means|85.65|||||TWO_SIDED|90.0|64.96|112.94|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||112.94|64.96|
91725417|NCT05788328|183345226|OTHER||Ratio of Adjusted Geometric Means|80.81|||||TWO_SIDED|90.0|61.28|106.55|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||106.55|61.28|
91725418|NCT05788328|183345227|OTHER||Ratio of Adjusted Geometric Means|229.11|||||TWO_SIDED|90.0|185.23|283.37|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||283.37|185.23|
91725419|NCT05788328|183345227|OTHER||Ratio of Adjusted Geometric Means|214.73|||||TWO_SIDED|90.0|173.38|265.94|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||265.94|173.38|
91725420|NCT05788328|183345228|OTHER||Ratio of Adjusted Geometric Means|213.05|||||TWO_SIDED|90.0|170.46|266.29|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||266.29|170.46|
91725421|NCT05788328|183345228|OTHER||Ratio of Adjusted Geometric Means|232.32|||||TWO_SIDED|90.0|185.88|290.38|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||290.38|185.88|
91725422|NCT05788328|183345236|OTHER||Ratio of Adjusted Geometric Means|45.25|||||TWO_SIDED|90.0|33.97|60.27|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||60.27|33.97|
91725423|NCT05788328|183345236|OTHER||Ratio of Adjusted Geometric Means|47.44|||||TWO_SIDED|90.0|35.62|63.19|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||63.19|35.62|
91725424|NCT05788328|183345241|OTHER||Ratio of Adjusted Geometric Means|176.39|||||TWO_SIDED|90.0|135.51|229.6|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||229.60|135.51|
91725425|NCT05788328|183345241|OTHER||Ratio of Adjusted Geometric Means|221.62|||||TWO_SIDED|90.0|170.26|288.48|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||288.48|170.26|
91725426|NCT01286324|183345287|SUPERIORITY|||||||0.21||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.21
91725427|NCT01286324|183345288|SUPERIORITY|||||||0.6||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.60
91490234|NCT01687998|182852904|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.001||||0.9874|TWO_SIDED|95.0|0.901|1.112|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization||1.112|0.901|0.9874
91725428|NCT01286324|183345289|SUPERIORITY|||||||0.47||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||Statistical Analysis for State Subscale||||0.47
91725429|NCT01286324|183345289|SUPERIORITY|||||||0.45||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||P-value for Trait Subscale||||0.45
91725430|NCT01286324|183345290|SUPERIORITY|||||||0.11||||||P value is adjusted based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.11
91725431|NCT05278065|183345306|SUPERIORITY||Mean Difference (Final Values)|8.09||||0.004|TWO_SIDED|95.0|3.2|12.98|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||12.98|3.20|.004
91725432|NCT05278065|183345306|SUPERIORITY||Mean Difference (Final Values)|6.74||||0.06|TWO_SIDED|95.0|-0.4|13.87|||t-test, 2 sided||Paired t-test|Repeated measures analysis at BL and Wk 8 for control arm||13.87|-0.40|.060
91725433|NCT05278065|183345306|SUPERIORITY||Slope|-0.932||||0.766|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||.766
91725434|NCT05278065|183345306|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.533|TWO_SIDED|95.0|-3.41|6.19|||t-test, 2 sided|Paired t-test||Repeated measures analysis at Wk 8 and Wk 16 for experimental arm||6.19|-3.41|0.533
91725435|NCT05278065|183345306|SUPERIORITY||Mean Difference (Final Values)|-3.69||||0.296|TWO_SIDED|95.0|-12.21|4.84|||t-test, 2 sided|Paired t-test||Repeated measures analysis at Wk 8 and Wk 16 for control arm||4.84|-12.21|0.296
91725436|NCT05278065|183345306|SUPERIORITY||Slope|-5.075||||0.14|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.14
91725437|NCT05278065|183345306|SUPERIORITY||Mean Difference (Final Values)|9.48||||0.002|TWO_SIDED|95.0|4.24|14.71|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 16 for experimental arm||14.71|4.24|.002
91725438|NCT05278065|183345306|SUPERIORITY||Mean Difference (Final Values)|3.05||||0.291|TWO_SIDED|95.0|-3.91|10.01|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||10.01|-3.91|.291
91725439|NCT05278065|183345306|SUPERIORITY||Slope|-5.834||||0.067|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||.067
91490235|NCT01687998|182852905|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.003||||0.9574|TWO_SIDED|95.0|0.893|1.127|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA||1.127|0.893|0.9574
91490236|NCT01687998|182852906|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.965||||0.5917|TWO_SIDED|95.0|0.846|1.1|||Regression, Cox|||Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke||1.100|0.846|0.5917
91725440|NCT05278065|183345307|SUPERIORITY||Mean Difference (Final Values)|0.82||||0.068|TWO_SIDED|95.0|-0.07|1.71|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||1.71|-0.07|.068
91725441|NCT05278065|183345307|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-2.32|2.32|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||2.32|-2.32|1.00
91725442|NCT05278065|183345307|SUPERIORITY||Slope|-0.66||||0.44|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.44
91513226|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.75||||||95.0|0.69|0.81||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.69|
91725443|NCT05278065|183345308|SUPERIORITY||Mean Difference (Final Values)|0.447||||0.145|TWO_SIDED|95.0|-0.184|1.078|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||1.078|-0.184|.145
91725444|NCT05278065|183345308|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.28|TWO_SIDED|95.0|-1.5|3.95|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||3.95|-1.50|0.280
91725445|NCT05278065|183345308|SUPERIORITY||Slope|0.802||||0.38|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.38
91725446|NCT05278065|183345309|SUPERIORITY||Mean Difference (Final Values)|0.086||||0.268|TWO_SIDED|95.0|-0.077|0.25|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||0.250|-0.077|0.268
91725447|NCT05278065|183345309|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.624|TWO_SIDED|95.0|-0.291|0.198|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||0.198|-0.291|0.624
91725448|NCT05278065|183345309|SUPERIORITY||Slope|-0.15||||0.17|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.17
91725449|NCT05278065|183345310|SUPERIORITY||Mean Difference (Final Values)|-0.077||||0.574|TWO_SIDED|95.0|-0.374|0.219|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||0.219|-0.374|0.574
91725450|NCT05278065|183345310|SUPERIORITY||Mean Difference (Final Values)|0.116||||0.077|TWO_SIDED|95.0|-0.02|0.252|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||0.252|-0.020|.077
91513227|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.65|0.8||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.80|0.65|
91513228|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.71|0.89||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.89|0.71|
91725451|NCT05278065|183345310|SUPERIORITY||Slope|0.193||||0.149|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||.149
91725452|NCT05278065|183345311|SUPERIORITY||Mean Difference (Final Values)|-0.116||||0.376|TWO_SIDED|95.0|-0.396|0.163|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||0.163|-0.396|0.376
91725453|NCT05278065|183345311|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.065|TWO_SIDED|95.0|-0.036|0.78|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||0.78|-0.036|0.065
91725454|NCT05278065|183345311|SUPERIORITY||Slope|0.486||||0.006|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||.006
91528149|NCT01614847|182931501|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
91528150|NCT00249496|182931503|SUPERIORITY||Odds Ratio (OR)|3.73||||0.004|TWO_SIDED|95.0|1.6|8.69|||General Estimating Equation (GEE)|||||8.69|1.60|.004
91725455|NCT05278065|183345312|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.849|TWO_SIDED|95.0|-0.483|0.576|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||0.576|-0.483|0.849
91725456|NCT05278065|183345312|SUPERIORITY||Mean Difference (Final Values)|-0.302||||0.107|TWO_SIDED|95.0|-0.706|0.102|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||0.102|-0.706|.107
91528151|NCT00249496|182931505|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.57|TWO_SIDED|95.0|0.26|2.43|||General Estimating Equation (GEE)|||||2.43|0.26|=0.57
91725457|NCT05278065|183345312|SUPERIORITY||Slope|-0.34||||0.19|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.19
91725458|NCT05278065|183345313|SUPERIORITY||Mean Difference (Final Values)|-0.085||||0.828|TWO_SIDED|95.0|-0.929|0.76|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for experimental arm||0.760|-0.929|0.828
91725459|NCT05278065|183345313|SUPERIORITY||Mean Difference (Final Values)|0.762||||0.249|TWO_SIDED|95.0|-0.81|2.33|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||2.33|-0.81|0.249
91725460|NCT05278065|183345313|SUPERIORITY||Slope|0.857||||0.17|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.17
91725461|NCT05278065|183345314|SUPERIORITY||Mean Difference (Final Values)|-0.182||||0.965|TWO_SIDED|95.0|-9.25|8.89|||t-test, 2 sided|Paired t-test||||8.89|-9.25|0.965
91528152|NCT00249496|182931507|SUPERIORITY||Odds Ratio (OR)|0.0||||0.046|TWO_SIDED|95.0|0.0|0.0|||General Estimating Equation (GEE)||The Odds Ratio and Confidence Intervals could not be calculated because one of the groups was at 0.|||0|0|0.046
91528153|NCT02693834|182931511|OTHER|Paired t test||||||0.293|||||||t-test, 2 sided|||In order to test the difference in gait endurance,between the two AFO conditions at baseline, a paired t-test was analyzed||||.293
91528154|NCT02693834|182931512|OTHER|Repeated measures ANOVA||||||0.077||||||The above value was the interaction between the type of AFO and practice time.|repeated measures ANOVA|||A repeated measures ANOVA was calculated to find the differences in gait endurance between the type of AFO and practice time.||||0.077
91528155|NCT02693834|182931512|OTHER|Repeated measures ANOVA||||||0.046||||||main effect of the type of AFO: F(1, 19) = 4.58, ηp2= .194|repeated measures ANOVA|||The main effect of type of AFO||||.046
91725462|NCT05278065|183345314|SUPERIORITY||Mean Difference (Final Values)|3.25||||0.522|TWO_SIDED|95.0|-11.1|17.6|||t-test, 2 sided|Paired t-test||Repeated measures analysis at BL and Wk 8 for control arm||17.6|-11.1|0.522
91725463|NCT05278065|183345314|SUPERIORITY||Slope|1.41||||0.781|TWO_SIDED||||||GEE|Corstr = AR1; test of condition x time interaction||||||0.781
91725464|NCT02070991|183345322|SUPERIORITY_OR_OTHER||Difference between maci. and placebo|10.08||||0.3372|TWO_SIDED|95.0|-15.07|33.26|||Fisher Exact|||||33.26|-15.07|0.3372
91725465|NCT02070991|183345323|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.77|||||TWO_SIDED|95.0|0.55|1.08||||||||1.08|0.55|
91725466|NCT02070991|183345324|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
91725467|NCT02070991|183345325|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.3|||||TWO_SIDED|95.0|-4.3|4.9||||||||4.9|-4.3|
91725468|NCT02070991|183345326|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.7|||||TWO_SIDED|95.0|-2.2|3.6||||||||3.6|-2.2|
91725469|NCT02070991|183345327|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.3|||||TWO_SIDED|95.0|-4.2|3.7||||||||3.7|-4.2|
91725470|NCT02070991|183345328|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.4|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
91725471|NCT02070991|183345329|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.4|||||TWO_SIDED|95.0|-4.5|3.6||||||||3.6|-4.5|
91725472|NCT04999020|183345330|SUPERIORITY||Difference in response rates|-15.38||||0.4192|TWO_SIDED|80.0|-38.55|8.48|||Barnard's unconditional exact test|||||8.48|-38.55|0.4192
91725473|NCT03296345|183345372|OTHER||Mean Difference (Final Values)|-15.0||||0.004|TWO_SIDED|95.0|-28.0|-2.3|||Wilcoxon (Mann-Whitney)|||||-2.3|-28|0.004
91725474|NCT03296345|183345373|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91725475|NCT03296345|183345374|OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
91725476|NCT03296345|183345376|OTHER|A Wilcoxon sign-rank, given non parametric data, was used to compare the intervention and historical control groups for statistical significance, while a student's t-test was used to estimate effect size||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91725477|NCT06038643|183345386|OTHER||||||<|0.001||||||Adjusted for multiple comparisons using False Discovery Rate.|Wilcoxon (Mann-Whitney)|||||||<0.001
91725478|NCT06038643|183345389|SUPERIORITY||||||<|0.01|||||||ANCOVA|||We conducted one-way analyses of covariance (ANCOVAs) to assess the effect of group (intervention vs. control) on post-intervention secondary outcomes, including cognition (Test My Brain Digital Neuropsychology Toolkit). Covariates in all models included age, sex, years of education, APOE4 status, and baseline scores.||||<0.01
91725479|NCT00699751|183345419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||5e-05|TWO_SIDED|95.0|0.578|0.827|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.827|0.578|0.00005
91725480|NCT00699751|183345420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.169|||<|1e-05|TWO_SIDED|95.0|0.131|0.22|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.22|0.131|<0.00001
91725481|NCT00699751|183345421|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725482|NCT00699751|183345421|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725483|NCT00699751|183345421|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=30%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725484|NCT00699751|183345421|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725485|NCT00699751|183345422|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725486|NCT00699751|183345422|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725487|NCT00699751|183345422|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725488|NCT00699751|183345423|SUPERIORITY_OR_OTHER||||||<|0.001||||||Total ALP normalization|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725489|NCT00699751|183345424|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage Change from Baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725490|NCT00699751|183345425|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline to week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725491|NCT00699751|183345426|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage change from baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725492|NCT00699751|183345427|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline during the 24 week treatment|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725493|NCT00699751|183345428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.643|||<|1e-05|TWO_SIDED|95.0|0.539|0.768||Time to Prostate Specific Antigen (PSA) progression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.768|0.539|<0.00001
91490237|NCT01663532|182852910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0005|TWO_SIDED|95.0|-6.1|-1.7||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-1.7|-6.1|0.0005
91725494|NCT00699751|183345429|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725495|NCT00699751|183345429|SUPERIORITY_OR_OTHER|||||||0.106||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.106
91725496|NCT00699751|183345429|SUPERIORITY_OR_OTHER|||||||0.032||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.032
91725497|NCT00699751|183345430|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725498|NCT00699751|183345430|SUPERIORITY_OR_OTHER|||||||0.002||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.002
91725499|NCT00699751|183345430|SUPERIORITY_OR_OTHER|||||||0.005||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.005
91490238|NCT01663532|182852910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.0||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-4.0|-10.0|<.0001
91695105|NCT00769067|183285209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.822||||0.252|TWO_SIDED|95.0|0.587|1.151||2-Sided.|Log Rank|Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.||1.151|0.587|0.252
91695106|NCT00594100|183285258|SUPERIORITY_OR_OTHER||Binomial Proportion|0.054|STANDARD_ERROR_OF_MEAN|0.016||0.002|TWO_SIDED|95.0|0.027|0.095|||One-Sample Binomial|Significance test was based on a one-sample binomial test|95% Confidence Interval is exact binomial using Clopper-Pearson method. Standard Error is from Normal approximation.|The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.||0.095|0.027|0.002
91695107|NCT05656534|183285277|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.31||0.19|TWO_SIDED|95.0|-0.2|1.1|||ANOVA|||||1.10|-0.20|.19
91695108|NCT05656534|183285278|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.33||0.03|TWO_SIDED|95.0|0.07|1.38|||ANOVA|||We conducted a repeated measures analysis of variable with session (pre-treatment vs. post-treatment) as a within-subjects variable and treatment arm as a between-subjects variable. Standardized residual scores reflecting startle reactivity to unpredictable threat (\> no-threat) was the dependent variable.||1.38|0.07|0.03
91695109|NCT05656534|183285279|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
91695110|NCT05656534|183285280|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.28|<|0.05|TWO_SIDED|95.0|-0.01|1.2|||ANOVA|Repeated measures ANOVA modeling session (pre. vs. post) by treatment arm||A session (pre vs. post) by treatment arm (suvorexant vs. placebo) repeated measures analysis of variance (ANOVA) was performed. The effect of session was then probed within each treatment arm.||1.20|-0.01|<.05
91695111|NCT00302848|183285281|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.|Hazard Ratio (HR)|1.0|||<|0.05||95.0|0.6|1.8|||Regression, Cox|||Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)||1.8|0.6|<0.05
91695112|NCT02801617|183285283|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 2 mmHg analysis by protocol||||||0.861|||||||t-test, 2 sided|||||||0.861
91695113|NCT02801617|183285283|NON_INFERIORITY|it will be considered not inferior if they keep the TIOP with differences of no more than 2 mmHg||||||0.89|||||||t-test, 2 sided|||||||0.890
91695114|NCT02801617|183285284|NON_INFERIORITY|intention-to-treat analysis (ITT)||||||0.329|||||||Chi-squared|||||||0.329
91695115|NCT02801617|183285285|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.388|||||||Chi-squared, Corrected|||||||0.388
91695116|NCT02801617|183285286|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.125|||||||Chi-squared, Corrected|||||||0.125
91695117|NCT02801617|183285287|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.434|||||||Chi-squared, Corrected|||||||0.434
91695118|NCT02801617|183285288|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0|||||||Chi-squared, Corrected|||||||0
91695119|NCT02801617|183285289|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.039|||||||Chi-squared|||||||0.039
91695120|NCT03421210|183285298|OTHER|||||||0.001|||||||t-test, 1 sided|||Differences in brain activation in response to personal smoking versus standard smoking cues were examined.||||0.001
91695121|NCT01057810|183285301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.3667|TWO_SIDED|95.87|0.88|1.39|||Log Rank||Hazard ratio = ipilimumab over placebo|||1.39|0.88|0.3667
91695122|NCT01057810|183285302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.55|0.8|||||HR = ipilimumab over placebo|||0.80|0.55|
91695123|NCT01057810|183285303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.87|0.52|0.83|||||HR = Ipilimumab over placebo|||0.83|0.52|
91695124|NCT01057810|183285304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.87|0.71|1.35|||||HR = Ipilimumab over placebo|||1.35|0.71|
91528156|NCT02693834|182931512|OTHER|Repeated measures ANOVA|||||<|0.001||||||main effect of practice: F(1, 19) = 43.94, ηp2 = .698|repeated measures ANOVA|||Main effect of practice||||<.001
91528157|NCT02693834|182931513|OTHER|paired t test||||||0.688|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for self selected velocity||||.688
91695125|NCT00267969|183285307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91695126|NCT00267969|183285307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
91695127|NCT00267969|183285308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel(CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91695128|NCT00267969|183285308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
91695129|NCT00267969|183285309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
91695130|NCT00267969|183285309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
91695131|NCT00267969|183285310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91695132|NCT00267969|183285310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91695133|NCT00267969|183285310|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.||||0.001
91695134|NCT00862823|183285311|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined so there was an 80% chance that a 90% pairwise interval for 2 equivalent formulations would satifsy the FDA criteria for AUC and Cmax of log (0.8), log (1.2).|Geometric Mean Ratio|0.97|||<|0.05||90.0||||Bioequivalent measurew were log-transformed|log transformation|||||||<0.05
91695135|NCT01309360|183285315|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
91695136|NCT01309360|183285315|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
91695137|NCT01309360|183285315|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
91695138|NCT01309360|183285316|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Kruskal-Wallis|||||||0
91695139|NCT01309360|183285317|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||Fisher Exact|||||||0.059
91695140|NCT01309360|183285317|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91695141|NCT01309360|183285317|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
91695142|NCT01309360|183285318|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Fisher Exact|||||||0.675
91695143|NCT01309360|183285318|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
91695144|NCT01309360|183285318|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Fisher Exact|||||||0.348
91695145|NCT01309360|183285319|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.247
91695146|NCT01309360|183285319|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91695147|NCT01309360|183285319|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91695148|NCT01309360|183285320|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
91695149|NCT01309360|183285320|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
91695150|NCT01309360|183285320|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
91695151|NCT00942890|183285330|SUPERIORITY_OR_OTHER||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91695152|NCT00942890|183285336|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
91695153|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.31||||0.0025|TWO_SIDED|90.0|0.17|0.57|||t-test, 2 sided|||||0.57|0.17|0.0025
91695154|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|0.74||||0.454|TWO_SIDED|90.0|0.38|1.45|||t-test, 2 sided|||||1.45|0.38|0.4540
91695155|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|4.69||||0.0003|TWO_SIDED|90.0|2.46|8.94|||t-test, 2 sided|||||8.94|2.46|0.0003
91695156|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|2.22||||0.046|TWO_SIDED|90.0|1.16|4.24|||t-test, 2 sided|||||4.24|1.16|0.0460
91695157|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.76||||0.3365|TWO_SIDED|90.0|0.47|1.22|||t-test, 2 sided|||||1.22|0.47|0.3365
91695158|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.56||||0.0313|TWO_SIDED|90.0|0.37|0.87|||t-test, 2 sided|||||0.87|0.37|0.0313
91695159|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.08||||0.806|TWO_SIDED|90.0|0.65|1.79|||t-test, 2 sided|||||1.79|0.65|0.8060
91695160|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|1.74||||0.2044|TWO_SIDED|90.0|0.84|3.58|||t-test, 2 sided|||||3.58|0.84|0.2044
91695161|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|1.67||||0.149|TWO_SIDED|90.0|0.93|3.02|||t-test, 2 sided|||||3.02|0.93|0.1490
91695162|NCT02308540|183285353|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|1.13||||0.7565|TWO_SIDED|90.0|0.59|2.15|||t-test, 2 sided|||||2.15|0.59|0.7565
91695163|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 1 GMC Ratio|0.75||||0.2653|TWO_SIDED|90.0|0.54|1.31|||Two-tailed from z-test|||||1.31|0.54|0.2653
91695164|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 5 GMC Ratio|0.69||||0.2059|TWO_SIDED|90.0|0.45|1.2|||Two-tailed from z-test|||||1.20|0.45|0.2059
91725500|NCT00699751|183345431|SUPERIORITY_OR_OTHER|||||||0.16||||||Percentage change from baseline in PSA at Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.160
91725501|NCT00699751|183345432|SUPERIORITY_OR_OTHER|||||||0.004||||||Maximum Percentage Decrease from Baseline up to Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.004
91725502|NCT00699751|183345433|SUPERIORITY_OR_OTHER|||||||0.009||||||Percentage change from baseline in PSA at EOT|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.009
91725503|NCT00699751|183345434|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
91725504|NCT00699751|183345435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.00012|TWO_SIDED|95.0|0.529|0.814||Time to first Skeletal Related Event (SRE)|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.814|0.529|0.00012
91725505|NCT00699751|183345436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.639||||8e-05|TWO_SIDED|95.0|0.511|0.8||Time to External Beam Radiotherapy|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.8|0.511|0.00008
91725506|NCT00699751|183345437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.344||||0.00191|TWO_SIDED|95.0|0.17|0.695||stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.695|0.17|0.00191
91725507|NCT00699751|183345438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847||||0.53277|TWO_SIDED|95.0|0.504|1.426||Time to Pathological Bone Fracture|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||1.426|0.504|0.53277
91725508|NCT00699751|183345439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||0.89567|TWO_SIDED|95.0|0.435|2.07||Time to Surgical Intervention|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||2.07|0.435|0.89567
91725509|NCT00699751|183345440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.14486|TWO_SIDED|95.0|0.404|1.145||Time to Spinal Cord Compression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||1.145|0.404|0.14486
91725510|NCT00699751|183345441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.727||||0.00932|TWO_SIDED|95.0|0.571|0.925||Time to Other Cancer Treatment|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.925|0.571|0.00932
91725511|NCT00699751|183345442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.00187|TWO_SIDED|95.0|0.546|0.873||Time to Marked Deterioration of ECOG PS|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.873|0.546|0.00187
91725512|NCT00294398|183345462|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
91725513|NCT01181479|183345486|EQUIVALENCE|Comparison of AG200-15 and Lessina for cycles 1-6.||||||0.067|||||||Chi-squared|||||||0.067
91725514|NCT02114684|183345492|SUPERIORITY|||||||0.46|||||||Fisher Exact|||comparison of culture negative results at week 8||||0.46
91725515|NCT02114684|183345492|SUPERIORITY|||||||0.43|||||||Fisher Exact|||comparison of culture negative results at month 6||||0.43
91725516|NCT02114684|183345493|SUPERIORITY|||||||0.018|||||||Gehan-Breslow-Wilcoxon test|||||||0.018
91725517|NCT02114684|183345494|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
91513229|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77||||||95.0|0.7|0.84||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.84|0.70|
91528158|NCT02693834|182931513|OTHER|repeated measures MANOVA||||||0.397||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at the self selected velocity F(1, 19)= 0.75, ηp2 = .038|repeated measures MANOVA|||The significance of differences in gait symmetry at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.397
91725518|NCT02114684|183345495|SUPERIORITY|||||||0.01||||||There are significantly more adverse events in the active arm|Mantel Haenszel|||Comparison of the number of adverse events in the two arms, controlling for HIV status||||0.01
91725519|NCT02114684|183345495|SUPERIORITY|||||||0.45|||||||Mantel Haenszel|||Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status||||0.45
91725520|NCT02114684|183345496|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
91725521|NCT03345095|183345505|SUPERIORITY||Mean Difference (Net)|-6.4||||0.0004|TWO_SIDED|95.0|-8.6|-2.5|||Wilcoxon (Mann-Whitney)|||||-2.5|-8.6|0.0004
91725522|NCT03345095|183345506|SUPERIORITY||Mean Difference (Net)|-0.55||||0.15|TWO_SIDED|95.0|-1.27|0.16|||Wilcoxon (Mann-Whitney)|||||0.16|-1.27|0.15
91725523|NCT00223821|183345507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|7.65||0.16|TWO_SIDED|95.0|-5.13|25.54|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.||25.54|-5.13|.16
91725524|NCT00223821|183345508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|8.71||0.37|TWO_SIDED|95.0|-10.73|24.33|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||||24.33|-10.73|.37
91725525|NCT06875115|183345532|SUPERIORITY|The primary outcome (5-D Itch Scale score) will be analyzed by comparing the change from baseline to 4 weeks between the laser acupuncture group and the sham laser group. Continuous variables will be summarized as mean ± standard deviation. Between-group comparisons will be performed using independent t-tests or Mann-Whitney U tests, as appropriate. A two-sided p value \< 0.05 will be considered statistically significant.|||||<|0.05|||||||t-test, 1 sided|||Primary Outcome Analysis||||<0.05
91725526|NCT06922760|183345535|OTHER|Statistical Test of Hypothesis||||||0.411|||||||Regression, Linear|||||||0.411
91725527|NCT06922760|183345535|OTHER|Statistical Test of Hypothesis||||||0.161|||||||Regression, Linear|||||||0.161
91528159|NCT02693834|182931513|OTHER|A repeated measures MANOVA||||||0.95||||||Main effect of AFO on gait symmetry at SSV: F(1, 19) = 0.004, ηp2 =.00|Repeated measures MANOVA|||Main effect of AFO on gait symmetry was analyzed at self selected velocity||||.950
91528160|NCT02693834|182931513|OTHER|Repeated measures MANOVA||||||0.111||||||The main effect of practice on gait symmetry at self selected velocity F(1, 19) = 2.79, ηp2 = .128|repeated measures MANOVA|||Main effect of practice on gait symmetry at Self selected velocity||||.111
91528161|NCT02693834|182931513|OTHER|||||||0.26|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for fast paced velocity||||.260
91725528|NCT06922760|183345536|OTHER|Statistical Test of Hypothesis||||||0.007|||||||Regression, Linear|||||||0.007
91725529|NCT06922760|183345536|OTHER|Statistical Test of Hypothesis||||||0.5|||||||Regression, Linear|||||||0.5
91725530|NCT02564978|183345542|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.39|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.39
91725531|NCT02564978|183345543|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.48|TWO_SIDED|95.0|-0.06|0.03||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.03|-0.06|0.48
91725532|NCT02564978|183345543|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|95.0|-0.24|0.04||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.04|-0.24|0.15
91725533|NCT02564978|183345543|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.15|TWO_SIDED|95.0|-0.09|0.01||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes (Study eye + QFE) together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.01|-0.09|0.15
91725534|NCT02564978|183345544|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.61|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.61
91725535|NCT02564978|183345544|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08||0.43|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.43
91725536|NCT02564978|183345544|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.89|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||Study eye + QFE: study \& qualifying fellow eyes analyzed as separate observations. Estimate: difference in rate of change in mean of appropriately transformed GA area between treatment and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study and qualifying fellow eyes together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.89
91725537|NCT02564978|183345545|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.44
91725538|NCT02564978|183345545|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.21|TWO_SIDED|95.0|-0.8|0.2||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.2|-0.8|0.21
91725539|NCT02564978|183345545|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.52|TWO_SIDED|95.0|-0.4|0.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.8|-0.4|0.52
91725540|NCT02564978|183345546|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.48|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.48
91725541|NCT02564978|183345546|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.09|TWO_SIDED|95.0|-0.9|0.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.1|-0.9|0.09
91490239|NCT01663532|182852910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.8|-5.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-5.6|-12.8|<.0001
91490240|NCT01663532|182852910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-15.0|-7.3||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-7.3|-15.0|<.0001
91490241|NCT01663532|182852910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-18.4|-9.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-9.6|-18.4|<.0001
91490242|NCT01663532|182852910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-10.8|-19.4|<.0001
91490243|NCT01663532|182852911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0001|TWO_SIDED|95.0|-0.4|-0.1||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.1|-0.4|0.0001
91490244|NCT01663532|182852911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.2|-0.6|<.0001
91490245|NCT01663532|182852911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-0.7|<.0001
91528162|NCT02693834|182931513|OTHER|repeated measures MANOVA||||||0.113||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at fast paced velocity FPV F(1, 19) = 2.76,, ηp2 = .127|repeated measures MANOVA|||The significance of differences in gait symmetry at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA||||.113
91758703|NCT00235716|183410637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.84|TWO_SIDED|95.0|-1.72|1.21||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.21|-1.72|0.84
91725542|NCT02564978|183345546|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.54|TWO_SIDED|95.0|-0.4|0.7||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.7|-0.4|0.54
91725543|NCT02564978|183345547|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||1.8|-0.4|0.20
91725544|NCT02564978|183345547|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.02|TWO_SIDED|95.0|0.4|3.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||3.1|0.4|0.02
91725545|NCT02564978|183345547|SUPERIORITY|Number of eyes contributing to this analysis exceeds the number of eyes contributing to the study eye only analysis since one participant had relevant data for the qualifying fellow eye but not the study eye.|Mean Difference (Final Values)|1.0||||0.06|TWO_SIDED|95.0|0.0|2.0||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||2.0|0.0|0.06
91725546|NCT02370394|183345614|SUPERIORITY||Mean Difference (Final Values)|-4.14||||0.4016|TWO_SIDED|95.0|-14.02|5.75|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||CAS Victimization Total Score at Follow Up||5.75|-14.02|0.4016
91725547|NCT02370394|183345614|SUPERIORITY||Mean Difference (Net)|14.46||||0.0072|TWO_SIDED|95.0|4.11|24.82|||t-test, 2 sided|||Change in CAS Victimization Total score from Baseline to Follow Up||24.82|4.11|0.0072
91725548|NCT02370394|183345615|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6011|TWO_SIDED|95.0|-0.21|0.12|||t-test, 2 sided|||Safety Behavior Change Score at Follow Up||0.12|-0.21|0.6011
91725549|NCT02370394|183345615|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9116|TWO_SIDED|95.0|-0.16|0.15|||t-test, 2 sided|||Change is Safety Behavior Change Score from Baseline to Follow Up||0.15|-0.16|0.9116
91725550|NCT02370394|183345616|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.8646|TWO_SIDED|95.0|-1.62|1.36|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||EOR Number of issues Effective at Accomplishing at Follow Up||1.36|-1.62|0.8646
91725551|NCT02370394|183345616|SUPERIORITY||Mean Difference (Net)|-0.86||||0.3045|TWO_SIDED|95.0|-2.54|0.82|||t-test, 2 sided|||Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up||0.82|-2.54|0.3045
91725552|NCT02370394|183345617|SUPERIORITY|||||||0.9085|||||||Wilcoxon (Mann-Whitney)|||Motivation Scale at Follow Up||||0.9085
91725553|NCT02370394|183345617|SUPERIORITY|||||||0.3256|||||||Wilcoxon (Mann-Whitney)|||Change in Motivation Scale from Baseline to Follow Up||||0.3256
91725554|NCT02370394|183345618|SUPERIORITY|||||||0.4085|||||||Wilcoxon (Mann-Whitney)|||Readiness at Follow Up||||0.4085
91725555|NCT02370394|183345618|SUPERIORITY|||||||0.2467|||||||Wilcoxon (Mann-Whitney)|||Change in Readiness from Baseline to Follow Up||||0.2467
91725556|NCT05890586|183345689|SUPERIORITY|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||Hazard ratios greater than one favored the active intervention for a faster time to recovery.|||1.07|0.86|
91528163|NCT02693834|182931513|OTHER|Repeated measures MANOVA||||||0.918||||||The main effect of AFO on gait symmetry at fast paced velocity: F(1, 19) = 0.01, ηp2 = 0.001|repeated measures MANOVA|||The main effect of AFO on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.918
91725557|NCT05890586|183345690|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.03|2.88|||||Low event rate precluded covariate adjustment.|||2.88|0.03|
91725558|NCT05890586|183345693|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.7|||||Hazard ratios less than one favor the active intervention of inhaled fluticasone furoate. The interval is a highest density credible interval.|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.||1.7|0.6|
91725559|NCT05890586|183345694|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.74|1.98|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||1.98|0.74|
91725560|NCT05890586|183345695|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.53|2.06|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.06|0.53|
91725561|NCT05890586|183345696|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.74|2.22|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.22|0.74|
91725562|NCT05890586|183345697|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.51|0.83|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.83|0.51|
91725563|NCT05890586|183345697|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.7|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.21|0.70|
91725564|NCT05890586|183345697|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.55|1.03|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.03|0.55|
91725565|NCT05890586|183345697|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.68|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.39|0.68|
91725566|NCT05890586|183345698|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.04|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.04|
91725567|NCT05890586|183345698|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.98|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.51|0.98|
91725568|NCT05890586|183345698|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.35|0.84|
91725569|NCT05890586|183345698|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.92|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.47|0.92|
91725570|NCT05890586|183345699|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.8|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.29|0.80|
91725571|NCT05890586|183345699|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.84|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.47|0.84|
91725572|NCT05890586|183345699|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.8|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.46|0.80|
91725573|NCT05890586|183345699|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.44|0.77|
91725574|NCT05890586|183345700|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.16|0.70|
91725575|NCT05890586|183345700|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.10|0.63|
91725576|NCT05890586|183345700|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||0.99|0.54|
91725577|NCT05890586|183345700|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.66|
91725578|NCT05890586|183345701|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.85|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.37|0.85|
91725579|NCT05890586|183345701|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.85|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.44|0.85|
91725580|NCT05890586|183345701|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.7|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.70|
91725581|NCT05890586|183345701|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.78|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.37|0.78|
91725582|NCT05890586|183345702|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.68|1.05|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.05|0.68|
91725583|NCT05890586|183345702|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.7|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.11|0.70|
91725584|NCT05890586|183345702|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.21|0.72|
91725585|NCT05890586|183345702|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
91725586|NCT05890586|183345703|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio, log|1.3|||||TWO_SIDED|95.0|1.05|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.05|
91725587|NCT05890586|183345703|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.52|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.52|1.00|
91725588|NCT05890586|183345703|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.27|0.84|
91513230|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.86||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.72|
91528164|NCT02693834|182931513|OTHER|Repeated measures MANOVA||||||0.077||||||The main effect of practice on gait symmetry at fast paced velocity: F(1, 19) = 3.50, ηp2 = .155|repeated measures MANOVA|||The main effect of practice on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.077
91725589|NCT05890586|183345703|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.21|0.80|
91725590|NCT05890586|183345704|SUPERIORITY||Difference in model estimate time unwell|-0.07|||||TWO_SIDED|95.0|-0.43|0.31|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.31|-0.43|
91725591|NCT05890586|183345705|SUPERIORITY||Difference in model estimated means|0.08|||||TWO_SIDED|95.0|-0.37|0.52|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.52|-0.37|
91725592|NCT01952678|183345723|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
91528165|NCT02693834|182931514|OTHER|A repeated measures MANOVA||||||0.209||||||The above p value is for the interaction effects between the type of AFO and practice time at self selected velocity: F(1, 19) = 1.69, ηp2 = .082|Repeated measures MANOVA|||The significance of differences in gait velocity at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.209
91725593|NCT01952678|183345723|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.0||||0.4608|TWO_SIDED|95.0|-25.8|12.1|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.1|-25.8|0.4608
91725594|NCT01952678|183345723|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
91513231|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.73|0.86||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.73|
91725595|NCT01952678|183345723|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
91725596|NCT01952678|183345724|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
91725597|NCT01952678|183345724|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.1||||0.4599|TWO_SIDED|95.0|-26.1|12.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.2|-26.1|0.4599
91725598|NCT01952678|183345724|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
91725599|NCT01952678|183345724|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
91725600|NCT01952678|183345725|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.0|22.0|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.0|-22.0|1.0000
91725601|NCT01952678|183345725|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.4||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
91725602|NCT01952678|183345725|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-2.0||||1|TWO_SIDED|95.0|-23.0|18.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||18.5|-23.0|1.0000
91725603|NCT01952678|183345725|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.3||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
91725604|NCT01952678|183345726|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.8|22.8|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.8|-22.8|1.0000
91528166|NCT02693834|182931514|OTHER|Repeated measures MANOVA||||||0.32||||||Main effect of AFO on gait velocity at self selected velocity: F(1, 19) = 1.05, ηp2 = .05|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed at self selected velocity||||.32
91725605|NCT01952678|183345726|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|5.2||||0.5187|TWO_SIDED|95.0|-16.7|26.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||26.2|-16.7|0.5187
91725606|NCT01952678|183345726|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-21.5|21.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||21.5|-21.5|1.0000
91725607|NCT01952678|183345726|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.7||||0.7123|TWO_SIDED|95.0|-19.1|23.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||23.9|-19.1|0.7123
91725608|NCT01952678|183345727|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.3|15.3|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.3|-13.3|1.0000
91725609|NCT01952678|183345727|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-3.8||||0.5731|TWO_SIDED|95.0|-17.7|9.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||9.8|-17.7|0.5731
91725610|NCT01952678|183345727|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.1||||1|TWO_SIDED|95.0|-13.8|13.8|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||13.8|-13.8|1.0000
91725611|NCT01952678|183345727|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.834|TWO_SIDED|95.0|-12.8|14.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||14.7|-12.8|0.8340
91725612|NCT01952678|183345728|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.5|15.6|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.6|-13.5|1.0000
91725613|NCT01952678|183345728|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-1.9||||0.8429|TWO_SIDED|95.0|-16.1|12.0|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.0|-16.1|0.8429
91725614|NCT01952678|183345728|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.8214|TWO_SIDED|95.0|-13.0|15.0|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.0|-13.0|0.8214
91725615|NCT01952678|183345728|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.2||||0.6577|TWO_SIDED|95.0|-12.0|16.1|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||16.1|-12.0|0.6577
91725616|NCT00422461|183345766|SUPERIORITY||Least square (LS) mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.6||0.0822|TWO_SIDED|95.0|-5.97|0.36|||Nonlinear dose response regression model|||||0.36|-5.97|0.0822
91528167|NCT02693834|182931514|OTHER|Repeated measures MANOVA||||||0.001||||||Main effect of practice on gait velocity at self selected velocity:F(1, 19) = 14.38, ηp2 = .431|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed at self selected velocity||||.001
91725617|NCT00422461|183345766|SUPERIORITY||LS mean difference|-4.66|STANDARD_ERROR_OF_MEAN|1.92||0.017|TWO_SIDED|95.0|-8.47|-0.85|||Nonlinear dose response regression model|||||-0.85|-8.47|0.0170
91725618|NCT00422461|183345766|SUPERIORITY||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|2.26||0.0026|TWO_SIDED|95.0|-11.45|-2.48|||Nonlinear dose response regression model|||||-2.48|-11.45|0.0026
91725619|NCT00422461|183345767|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0264|TWO_SIDED|95.0|-5.09|-0.32|||Nonlinear dose response regression model|||||-0.32|-5.09|0.0264
91725620|NCT00422461|183345767|SUPERIORITY||LS mean difference|-4.56|STANDARD_ERROR_OF_MEAN|1.41||0.0016|TWO_SIDED|95.0|-7.35|-1.77|||Nonlinear dose response regression model|||||-1.77|-7.35|0.0016
91725621|NCT00422461|183345767|SUPERIORITY||LS mean difference|-6.96|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-10.03|-3.89|||Nonlinear dose response regression model|||||-3.89|-10.03|<0.0001
91725622|NCT00422461|183345768|SUPERIORITY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.98||0.9479|TWO_SIDED|95.0|-3.79|4.05|||ANCOVA|||For SBP||4.05|-3.79|0.9479
91725623|NCT00422461|183345768|SUPERIORITY||LS mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.03||0.0215|TWO_SIDED|95.0|-8.78|-0.72|||ANCOVA|||For SBP||-0.72|-8.78|0.0215
91725624|NCT00422461|183345768|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.0||0.0886|TWO_SIDED|95.0|-7.39|0.53|||ANCOVA|||For SBP||0.53|-7.39|0.0886
91528168|NCT02693834|182931514|OTHER|repeated measures MANOVA||||||0.28||||||The above p value is for the interaction effects between the type of AFO and practice time at fast paced velocity: F( 1, 19) = 1.24, ηp2 = .61|repeated measures MANOVA|||The significance of differences in gait velocity at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.280
91725625|NCT00422461|183345768|SUPERIORITY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.44||0.3173|TWO_SIDED|95.0|-4.3|1.41|||ANCOVA|||For DBP||1.41|-4.30|0.3173
91725626|NCT00422461|183345768|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|1.42||0.0087|TWO_SIDED|95.0|-6.64|-0.99|||ANCOVA|||For DBP||-0.99|-6.64|0.0087
91528169|NCT02693834|182931514|OTHER|repeated measures MANOVA||||||0.072||||||Main effect of AFO on gait velocity was analyzed at self selected velocity:FPV F(1, 19) = 3.63, ηp2 =.16|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed for self selected velocity||||.072
91725627|NCT00422461|183345768|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.41||0.0062|TWO_SIDED|95.0|-6.76|-1.15|||ANCOVA|||For DBP||-1.15|-6.76|0.0062
91725628|NCT00422461|183345770|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.8091|TWO_SIDED|95.0|-5.51|4.31|||ANCOVA|||For cuff SBP||4.31|-5.51|0.8091
91725629|NCT00422461|183345770|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|2.44||0.8809|TWO_SIDED|95.0|-5.21|4.48|||ANCOVA|||For cuff SBP||4.48|-5.21|0.8809
91725630|NCT00422461|183345770|SUPERIORITY||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.46||0.0382|TWO_SIDED|95.0|-10.04|-0.29|||ANCOVA|||For cuff SBP||-0.29|-10.04|0.0382
91725631|NCT00422461|183345770|SUPERIORITY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|1.67||0.0731|TWO_SIDED|95.0|-6.35|0.29|||ANCOVA|||For cuff DBP||0.29|-6.35|0.0731
91725632|NCT00422461|183345770|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.65||0.0077|TWO_SIDED|95.0|-7.77|-1.22|||ANCOVA|||For cuff DBP||-1.22|-7.77|0.0077
91725633|NCT00422461|183345770|SUPERIORITY||LS mean difference|-4.29|STANDARD_ERROR_OF_MEAN|1.66||0.0111|TWO_SIDED|95.0|-7.58|-1.0|||ANCOVA|||For cuff DBP||-1.00|-7.58|0.0111
91725634|NCT00422461|183345772|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.7||0.2567|TWO_SIDED|95.0|-5.32|1.44|||ANCOVA|||||1.44|-5.32|0.2567
91725635|NCT00422461|183345772|SUPERIORITY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|1.69||0.086|TWO_SIDED|95.0|-6.29|0.42|||ANCOVA|||||0.42|-6.29|0.0860
91725636|NCT00422461|183345772|SUPERIORITY||LS mean difference|-4.46|STANDARD_ERROR_OF_MEAN|1.71||0.0103|TWO_SIDED|95.0|-7.85|-1.08|||ANCOVA|||||-1.08|-7.85|0.0103
91725637|NCT00908388|183345788|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||(1-Posterior probability of meeting performance goal given the data)|Bayesian adaptive|||||||.006
91725638|NCT01454063|183345814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001||95.0|0.475|0.678||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS - Placebo) adjusted for randomization strata.||||0.678|0.475|<0.0001
91725639|NCT01454063|183345815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.199|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001||95.0|-7.307|-3.091||p-value based on the generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302-placebo) adjusted for randomization strata.||||-3.091|-7.307|<0.0001
91725640|NCT01454063|183345816|SUPERIORITY_OR_OTHER|||||||0.0514||||||Treatment comparisons based on CMH test adjusting for randomization strata.|Cochran-Mantel-Haenszel|||||||0.0514
91725641|NCT01454063|183345817|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparisons based on CMH test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0034
91725642|NCT01454063|183345818|SUPERIORITY_OR_OTHER|||||||0.0963||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata. For subjects without a score due to inability to read the ETDRS chart, the log score will be imputed as 1.6 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.0963
91725643|NCT01454063|183345819|SUPERIORITY_OR_OTHER|||||||0.0532||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0532
91725644|NCT01454063|183345820|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||<0.0001
91725645|NCT03055195|183345914|OTHER||Proportions Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.|||23.3|-1.1|
91725646|NCT03055195|183345916|OTHER||Proportion Difference|-1.0|||||TWO_SIDED|90.0|-14.0|12.6|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.|||12.6|-14.0|
91725647|NCT03055195|183345916|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.|||23.3|-1.1|
91725648|NCT03055195|183345916|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.|||23.3|-1.1|
91725649|NCT03055195|183345916|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.|||23.3|-1.1|
91725650|NCT03055195|183345916|OTHER||Proportion Difference|6.0|||||TWO_SIDED|90.0|-3.3|14.4|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.|||14.4|-3.3|
91725651|NCT00421733|183345948|SUPERIORITY_OR_OTHER|||||||0.071||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.071
91725652|NCT00421733|183345948|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.||||||0.229
91725653|NCT00421733|183345948|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.053
91725654|NCT00421733|183345949|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Fisher Exact|||||||0.102
91725655|NCT00421733|183345949|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher Exact|||||||0.038
91725656|NCT00421733|183345950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.855|TWO_SIDED|95.0|-0.26|0.22|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||0.22|-0.26|0.855
91725657|NCT00421733|183345950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.009|TWO_SIDED|95.0|-0.57|-0.08|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||-0.08|-0.57|0.009
91725658|NCT00421733|183345951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
91725659|NCT00421733|183345951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
91725660|NCT01524705|183346056|SUPERIORITY||Wilcoxon||||<|0.024||||||Wilcoxon rank sum test was used due to nonnormality distribution|Wilcoxon (Mann-Whitney)|||Two-tailed t test with type I error = 0.05, a sample of 110 participants (55 per group) would give 90% power to detect a difference of a mean change from baseline of 5 CV units (SD = 8) between control and treatment groups. An ANCOVA model, adjusting for baseline value and clinical site, was to be performed. If residual values from the ANCOVA indicated nonnormality in distribution by Shapiro-Wilk testing, a Wilcoxon rank sum test was used instead.||||<0.024
91725661|NCT01524705|183346058|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91725662|NCT01524705|183346059|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91725663|NCT00412451|183346063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.001||||0.131|TWO_SIDED|95.0|0.001|999.999|||Fisher Exact|||||999.999|0.001|0.131
91725664|NCT00412451|183346063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.562||||0.67|TWO_SIDED|95.0|0.132|2.4|||Fisher Exact|||||2.400|0.132|0.670
91725665|NCT00412451|183346063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.346||||0.372||95.0|0.07|1.703|||Fisher Exact|||||1.703|0.070|0.372
91725666|NCT04018001|183346121|SUPERIORITY|||||||0.0115|||||||Chi-squared|||||||0.0115
91725667|NCT04018001|183346121|SUPERIORITY||Odds Ratio (OR)|1.410198||||0.0227|TWO_SIDED|95.0|1.0492535|1.8953079||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.8953079|1.0492535|0.0227
91725668|NCT04018001|183346122|SUPERIORITY|||||||0.3564|||||||t-test, 2 sided|||||||0.3564
91725669|NCT04018001|183346122|SUPERIORITY||Hazard Ratio (HR)|0.9022||||0.2629|TWO_SIDED|95.0|0.7534|1.0803||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.0803|0.7534|0.2629
91725670|NCT04018001|183346123|SUPERIORITY|||||||0.0123|||||||t-test, 2 sided|||||||0.0123
91725671|NCT04018001|183346123|SUPERIORITY||Difference in Least Squares (LS) Means|0.0300853||||0.0047|TWO_SIDED|95.0|0.0092322|0.0509385||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0509385|0.0092322|0.0047
91725672|NCT04018001|183346124|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
91725673|NCT04018001|183346124|SUPERIORITY||Odds Ratio (OR)|1.7910474||||0.0002|TWO_SIDED|95.0|1.3167136|2.4362554||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||2.4362554|1.3167136|0.0002
91725674|NCT04018001|183346125|SUPERIORITY|||||||0.4071|||||||t-test, 2 sided|||||||0.4071
91725675|NCT04018001|183346125|SUPERIORITY||Difference in LS Means|0.0104065||||0.6143|TWO_SIDED|95.0|-0.030062|0.0508746||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0508746|-0.030062|0.6143
91725676|NCT04018001|183346126|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.0010
91725677|NCT04018001|183346126|SUPERIORITY||Odds Ratio (OR)|1.5211586||||0.0025|TWO_SIDED|95.0|1.1594614|1.9956882||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9956882|1.1594614|0.0025
91725678|NCT04018001|183346127|SUPERIORITY|||||||0.4595|||||||t-test, 2 sided|||||||0.4595
91725679|NCT04018001|183346127|SUPERIORITY||Hazard Ratio (HR)|1.1225||||0.3354|TWO_SIDED|95.0|0.8873|1.4201||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.4201|0.8873|0.3354
91725680|NCT04018001|183346128|SUPERIORITY|||||||0.113|||||||t-test, 2 sided|||||||0.1130
91725681|NCT04018001|183346128|SUPERIORITY||Difference in LS Means|0.0151242||||0.1194|TWO_SIDED|95.0|-0.003908|0.0341568||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0341568|-0.003908|0.1194
91528170|NCT02693834|182931514|OTHER|Repeated measures MANOVA|||||<|0.001||||||Main effect of Practice on gait velocity for fast paced velocity: F(1, 19) = 23.73, ηp2 = .555|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed for fast paced velocity||||<.001
91725682|NCT04018001|183346129|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.0200
91725683|NCT04018001|183346129|SUPERIORITY||Odds Ratio (OR)|1.4143816||||0.0364|TWO_SIDED|95.0|1.0221455|1.9571335||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9571335|1.0221455|0.0364
91725684|NCT04018001|183346130|SUPERIORITY|||||||0.9031|||||||t-test, 2 sided|||||||0.9031
91725685|NCT04018001|183346130|SUPERIORITY||Difference in LS Means|-0.008587||||0.6376|TWO_SIDED|95.0|-0.044317|0.0271416||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0271416|-0.044317|0.6376
91725686|NCT04018001|183346131|SUPERIORITY|||||||0.3584|||||||Chi-squared|||||||0.3584
91725687|NCT04018001|183346131|SUPERIORITY||Odds Ratio (OR)|1.1077385||||0.451|TWO_SIDED|95.0|0.8489444|1.4454238||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.4454238|0.8489444|0.4510
91725688|NCT04018001|183346132|SUPERIORITY|||||||0.0624|||||||Chi-squared|||||||0.0624
91725689|NCT04018001|183346133|SUPERIORITY|||||||0.4914|||||||Chi-squared|||||||0.4914
91725690|NCT03767894|183346202|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|1.36||||0.24|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).||||0.24
91725691|NCT03767894|183346202|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|-1.72||||0.207|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).||||0.207
91725692|NCT03767894|183346203|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|2.64||||0.026|TWO_SIDED|||||a priori threshold: p\<0.05|Paired sample T-test|2-tailed||Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).||||0.026
91725693|NCT03767894|183346205|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.09||||0.442|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.||||0.442
91725694|NCT03767894|183346205|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.0||||1|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).||||1.0
91725695|NCT00387127|183346208|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|10.7||||0.3658|TWO_SIDED|95.0|-13.4|37.3||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by an independent radiological review.|||37.3|-13.4|0.3658
91725696|NCT00387127|183346209|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|28.8||||0.013|TWO_SIDED|95.0|5.7|53.6||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by the investigator.|||53.6|5.7|0.0130
91695165|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6A GMC Ratio|0.84||||0.5664|TWO_SIDED|90.0|0.55|1.54|||Two-tailed from z-test|||||1.54|0.55|0.5664
91528171|NCT02524054|182931515|SUPERIORITY|||||||0.35||||||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.||||0.35
91695166|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6B GMC Ratio|0.82||||0.4456|TWO_SIDED|90.0|0.57|1.31|||Two-tailed from z-test|||||1.31|0.57|0.4456
91695167|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 7F GMC Ratio|0.74||||0.2189|TWO_SIDED|90.0|0.52|1.14|||Two-tailed from z-test|||||1.14|0.52|0.2189
91695168|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 9V GMC Ratio|0.6||||0.097|TWO_SIDED|90.0|0.38|1.03|||Two-tailed from z-test|||||1.03|0.38|0.0970
91695169|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 14 GMC Ratio|1.76||||0.0713|TWO_SIDED|90.0|1.02|2.79|||Two-tailed from z-test|||||2.79|1.02|0.0713
91725697|NCT00387127|183346218|SUPERIORITY_OR_OTHER||Difference in overall response rate|16.3||||0.1969|TWO_SIDED|95.0|-8.6|42.1||From exact test that common odds ratio equals 1|Fisher Exact||Overall response was defined as the percentage of participants achieving a PR or CR as determined by the investigator.|||42.1|-8.6|0.1969
91725698|NCT00002874|183346257|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.02|TWO_SIDED|95.0|0.59|0.98||One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.|Log Rank||Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.|||0.98|0.59|0.020
91725699|NCT00002874|183346258|SUPERIORITY||Cox Proportional Hazard|1.1||||0.289|TWO_SIDED|95.0|0.79|1.53|||Gray's test|One-sided test|||Reference level = placebo arm|1.53|0.79|0.289
91725700|NCT00002874|183346259|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.58|||Gray's test|One-sided test|Reference level = placebo arm|||0.58|0.40|<0.001
91725701|NCT00002874|183346260|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.213|TWO_SIDED|95.0|0.85|1.46|||Gray's test|One-sided test|Reference level = placebo arm|||1.46|0.85|0.213
91725702|NCT00002874|183346261|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91725703|NCT00002874|183346262|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.46|0.87|||Gray's test|One-sided test|Reference level = placebo arm|||0.87|0.46|0.002
91725704|NCT00002874|183346263|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.32|0.74|||Gray's test|One-sided test|Reference level = placebo arm|||0.74|0.32|<0.001
91725705|NCT00002874|183346264|SUPERIORITY||Cox Proportional Hazard|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.71|||Log Rank|One-side test|||Reference level = placebo arm|0.71|0.50|< 0.001
91725706|NCT00002874|183346265|SUPERIORITY|||||||0.06|||||||Chi-squared|||Acute radiotherapy toxicity||||0.060
91725707|NCT00002874|183346265|SUPERIORITY|||||||0.029|||||||Chi-squared|||Hormone therapy and late radiotherapy toxicity||||0.029
91725708|NCT01734928|183346339|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.001|TWO_SIDED|95.0|0.49|0.77|||Based on Cox proportional hazards model|||||0.77|0.49|0.001
91528172|NCT02524054|182931516|SUPERIORITY||||||<|0.001||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.|t-test, 2 sided|||||||<0.001
91528173|NCT00759772|182931521|SUPERIORITY||||||<|0.01||||||Calculated p-value.|t-test, 2 sided|||||||< 0.01
91528174|NCT04548531|182931561|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.001|TWO_SIDED|95.0|0.41|0.94|||t-test, 2 sided|||||0.94|0.41|<.001
91725709|NCT01734928|183346340|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.571|TWO_SIDED|95.0|0.77|1.15|||Log Rank|The p-value is based on a stratified log-rank test with stratification factors as above Cox model.|Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.|||1.15|0.77|0.571
91725710|NCT01734928|183346342|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.064|TWO_SIDED|95.0|0.56|1.02|||Unstratified log-rank test|The p-value is based on an unstratified log-rank test.|Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.02|0.56|0.064
91725711|NCT02357485|183346368|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.004
91725712|NCT02357485|183346369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.001
91725713|NCT02357485|183346370|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
91725714|NCT02357485|183346371|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
91725715|NCT00397930|183346372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.3||0.009|TWO_SIDED|||||Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.|ANCOVA|ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.|The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.|"H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level."||||0.009
91725716|NCT00505362|183346384|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91725717|NCT00505362|183346385|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
91725718|NCT02400580|183346389|OTHER|||||||0.517|||||||Fisher Exact|||||||0.517
91725719|NCT02400580|183346391|OTHER|||||||0.508|||||||Fisher Exact|||||||0.508
91725720|NCT01060111|183346397|SUPERIORITY_OR_OTHER|||||||0.6207|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.6207
91725721|NCT01060111|183346397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferioirity was to be concluded if the ratio of percentage decrease in migraine episodes was greater than 0.7. Power of calculation was 0.9, significance level was 0.025.|Ratio of percentage decrease|0.95||||0.5|TWO_SIDED|95.0|0.519|1.737|||t-test, 1 sided|||||1.737|0.519|0.5
91725722|NCT01060111|183346398|SUPERIORITY_OR_OTHER|||||||0.7247|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.7247
91725723|NCT01060111|183346399|SUPERIORITY_OR_OTHER|||||||0.9872|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.9872
91725724|NCT01060111|183346400|SUPERIORITY_OR_OTHER|||||||0.4326||||||Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|ANOVA|||||||0.4326
91725725|NCT00976391|183346434|NON_INFERIORITY_OR_EQUIVALENCE|P-value from a one-sided t-test to test whether the difference of least square means (albiglutide - preprandial lispro insulin) is less than or equal to the pre-specified non-inferiority margin of 0.4%|Mean Difference (Net)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.32|0.0|||t-test, 1 sided|||||0.00|-0.32|<0.0001
91725726|NCT04676646|183346442|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.89|6.86|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||6.86|2.89|<0.001
91725727|NCT04676646|183346443|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.78|7.55|||GEE model||An odds ratio \>1 indicated increased odds of response on SZC compared to placebo.|||7.55|2.78|<0.001
91725728|NCT04676646|183346444|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.5|7.52|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||7.52|2.50|<0.001
91725729|NCT04676646|183346445|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001||95.0|0.37|0.71|||Regression, Cox||A hazard ratio less than 1 favors SZC to be associated with a longer time to first hyperkalaemia episode than placebo.|||0.71|0.37|<0.001
91725730|NCT04676646|183346446|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.006|TWO_SIDED|95.0|0.17|0.73|||Regression, Cox||A hazard ratio less than 1 favored SZC to be associated with a longer time to first instance of a decrease of spironolactone dose due to hyperkalaemia than placebo.|||0.73|0.17|0.006
91725731|NCT04676646|183346447|SUPERIORITY||Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|2.84||0.724|TWO_SIDED|95.0|-6.64|4.63|||t-test, 2 sided||A least-squares mean difference greater than 0 favors SZC compared to placebo.|||4.63|-6.64|0.724
91725732|NCT04270760|183346449|SUPERIORITY||Treatment difference|-70.51|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-75.12|-65.9||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Group 1 versus (vs) Group 5||-65.90|-75.12|<0.001
91528175|NCT04548531|182931562|SUPERIORITY||Risk Difference (RD)|21.0||||0.003|TWO_SIDED|95.0|7.0|35.0|||Chi-squared|||||35|7|0.003
91528176|NCT04548531|182931563|SUPERIORITY||Risk Difference (RD)|3.0||||0.75|TWO_SIDED|95.0|-10.0|16.0|||Chi-squared|||We tested for a clear preference for screening, if a patient chose a colonoscopy or a stool-based test vs. the other response options.||16|-10|.75
91725733|NCT04270760|183346449|SUPERIORITY||Treatment difference|-97.38|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-101.98|-92.77||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Group 2 vs Group 5||-92.77|-101.98|<0.001
91725734|NCT04270760|183346449|SUPERIORITY||Treatment difference|-101.13|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.79|-96.47||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Group 3 vs Group 5||-96.47|-105.79|<0.001
91725735|NCT04270760|183346449|SUPERIORITY||Treatment difference|-100.49|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.16|-95.82|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Group 4 vs Group 5||-95.82|-105.16|< 0.001
91725736|NCT04270760|183346450|SUPERIORITY||Treatment difference|-68.47|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-74.27|-62.67|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Group 1 vs Group 5||-62.67|-74.27|<0.001
91528177|NCT04548531|182931564|SUPERIORITY||Risk Difference (RD)|11.0||||0.14|TWO_SIDED|95.0|-3.0|26.0|||Chi-squared|||We categorized for likelihood to follow through with screening. We reported on results from patients who indicated 'Very Likely' on their response option vs. the other options (likely, unsure, unlikely, very unlikely)||26|-3|0.14
91725737|NCT04270760|183346450|SUPERIORITY||Treatment difference|-96.12|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-101.92|-90.33|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Group 2 vs Group 5||-90.33|-101.92|<0.001
91725738|NCT04270760|183346450|SUPERIORITY||Treatment difference|-100.88|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-106.74|-95.02|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Group 3 vs Group 5||-95.02|-106.74|<0.001
91725739|NCT04270760|183346450|SUPERIORITY||Treatment difference|-85.94|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-91.83|-80.06|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Group 4 vs Group 5||-80.06|-91.83|< 0.001
91725740|NCT04270760|183346451|SUPERIORITY||Treatment difference|-23.659|STANDARD_ERROR_OF_MEAN|5.874|<|0.001|TWO_SIDED|95.0|-35.176|-12.143|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-12.143|-35.176|<0.001
91725741|NCT04270760|183346451|SUPERIORITY||Treatment difference|-22.518|STANDARD_ERROR_OF_MEAN|5.875|<|0.001|TWO_SIDED|95.0|-34.036|-11.0|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-11.000|-34.036|<0.001
91725742|NCT04270760|183346451|SUPERIORITY||Treatment difference|-22.967|STANDARD_ERROR_OF_MEAN|5.962|<|0.001|TWO_SIDED|95.0|-34.656|-11.278|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-11.278|-34.656|<0.001
91725743|NCT04270760|183346451|SUPERIORITY||Treatment difference|-24.696|STANDARD_ERROR_OF_MEAN|5.969|<|0.001|TWO_SIDED|95.0|-36.399|-12.993|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-12.993|-36.399|< 0.001
91725744|NCT04270760|183346451|SUPERIORITY||Treatment difference|-24.856|STANDARD_ERROR_OF_MEAN|6.119|<|0.001|TWO_SIDED|95.0|-36.853|-12.859|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-12.859|-36.853|<0.001
91725745|NCT04270760|183346451|SUPERIORITY||Treatment difference|-21.594|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-33.59|-9.598|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-9.598|-33.590|<0.001
91725746|NCT04270760|183346451|SUPERIORITY||Treatment difference|-27.421|STANDARD_ERROR_OF_MEAN|6.194|<|0.001|TWO_SIDED|95.0|-39.565|-15.277|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-15.277|-39.565|<0.001
91695170|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19A GMC Ratio|0.71||||0.3443|TWO_SIDED|90.0|0.42|1.35|||Two-tailed from z-test|||||1.35|0.42|0.3443
91695171|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19F GMC Ratio|0.76||||0.3278|TWO_SIDED|90.0|0.48|1.23|||Two-tailed from z-test|||||1.23|0.48|0.3278
91695172|NCT02308540|183285354|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 23F GMC Ratio|0.65||||0.2039|TWO_SIDED|90.0|0.4|1.16|||Two-tailed from z-test|||||1.16|0.40|0.2039
91695173|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.89||||0.255|TWO_SIDED|90.0|0.74|1.06|||t-test, 2 sided|||||1.06|0.74|0.2550
91695174|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|1.2||||0.0865|TWO_SIDED|90.0|1.01|1.43|||t-test, 2 sided|||||1.43|1.01|0.0865
91695175|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|0.56||||0.0006|TWO_SIDED|90.0|0.43|0.74|||t-test, 2 sided|||||0.74|0.43|0.0006
91695176|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|0.43|||<|0.0001|TWO_SIDED|90.0|0.33|0.57|||t-test, 2 sided|||||0.57|0.33|<0.0001
91695177|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.56|||<|0.0001|TWO_SIDED|90.0|0.47|0.68|||t-test, 2 sided|||||0.68|0.47|<0.0001
91695178|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.49|||<|0.0001|TWO_SIDED|90.0|0.41|0.59|||t-test, 2 sided|||||0.59|0.41|<0.0001
91695179|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.11||||0.5234|TWO_SIDED|90.0|0.85|1.45|||t-test, 2 sided|||||1.45|0.85|0.5234
91695180|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|0.29|||<|0.0001|TWO_SIDED|90.0|0.22|0.36|||t-test, 2 sided|||||0.36|0.22|<0.0001
91695181|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|0.72||||0.004|TWO_SIDED|90.0|0.6|0.87|||t-test, 2 sided|||||0.87|0.60|0.0040
91695182|NCT02308540|183285355|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|0.58||||0.0001|TWO_SIDED|90.0|0.46|0.73|||t-test, 2 sided|||||0.73|0.46|0.0001
91725747|NCT04270760|183346451|SUPERIORITY||Treatment difference|-27.021|STANDARD_ERROR_OF_MEAN|6.232|<|0.001|TWO_SIDED|95.0|-39.24|-14.801|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-14.801|-39.240|<0.001
91725748|NCT04270760|183346452|SUPERIORITY||Treatment difference|-18.89|STANDARD_ERROR_OF_MEAN|3.779|<|0.001|TWO_SIDED|95.0|-26.303|-11.477|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-11.477|-26.303|<0.001
91725749|NCT04270760|183346452|SUPERIORITY||Treatment difference|-16.696|STANDARD_ERROR_OF_MEAN|3.778|<|0.001|TWO_SIDED|95.0|-24.107|-9.284|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-9.284|-24.107|<0.001
91725750|NCT04270760|183346452|SUPERIORITY||Treatment difference|-17.635|STANDARD_ERROR_OF_MEAN|3.825|<|0.001|TWO_SIDED|95.0|-25.139|-10.131|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-10.131|-25.139|<0.001
91725751|NCT04270760|183346452|SUPERIORITY||Treatment difference|-18.772|STANDARD_ERROR_OF_MEAN|3.839|<|0.001|TWO_SIDED|95.0|-26.303|-11.241|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-11.241|-26.303|< 0.001
91725752|NCT04270760|183346452|SUPERIORITY||Treatment difference|-20.04|STANDARD_ERROR_OF_MEAN|4.443|<|0.001|TWO_SIDED|95.0|-28.757|-11.323|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-11.323|-28.757|<0.001
91725753|NCT04270760|183346452|SUPERIORITY||Treatment difference|-17.06|STANDARD_ERROR_OF_MEAN|4.442|<|0.001|TWO_SIDED|95.0|-25.774|-8.345|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-8.345|-25.774|<0.001
91725754|NCT04270760|183346452|SUPERIORITY||Treatment difference|-19.509|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-28.336|-10.682|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-10.682|-28.336|<0.001
91725755|NCT04270760|183346452|SUPERIORITY||Treatment difference|-21.839|STANDARD_ERROR_OF_MEAN|4.517|<|0.001|TWO_SIDED|95.0|-30.7|-12.979|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-12.979|-30.700|<0.001
91528178|NCT04548531|182931565|SUPERIORITY||Risk Difference (RD)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|18.0|||Chi-squared|||Assessed how many patients completed any colorectal cancer screening test within 6-months after randomization.||18|6|<.001
91725756|NCT05156125|183346454|SUPERIORITY||Risk Difference (RD)|16.1||||0.0184|TWO_SIDED|95.0|2.58|29.05|||Cochran-Mantel-Haenszel|||At 13 weeks||29.05|2.58|0.0184
91725757|NCT05156125|183346454|SUPERIORITY||Risk Difference (RD)|13.1||||0.041|TWO_SIDED|95.0|-0.03|25.58|||Cochran-Mantel-Haenszel|||At 13 weeks||25.58|-0.03|0.0410
91725758|NCT05156125|183346455|SUPERIORITY||Risk Difference (RD)|20.6||||0.007|TWO_SIDED|95.0|5.73|34.42|||Cochran-Mantel-Haenszel|||At 13 weeks||34.42|5.73|0.0070
91725759|NCT05156125|183346455|SUPERIORITY||Risk Difference (RD)|17.3||||0.0162|TWO_SIDED|95.0|2.75|30.67|||Cochran-Mantel-Haenszel|||At Week 13||30.67|2.75|0.0162
91725760|NCT05156125|183346456|SUPERIORITY||Risk Difference (RD)|16.5||||0.0448|TWO_SIDED|95.0|0.65|31.37|||Cochran-Mantel-Haenszel|||||31.37|0.65|0.0448
91725761|NCT05156125|183346456|SUPERIORITY||Risk Difference (RD)|16.0||||0.0417|TWO_SIDED|95.0|0.23|30.58|||Cochran-Mantel-Haenszel|||At Week 13||30.58|0.23|0.0417
91725762|NCT05156125|183346457|SUPERIORITY||Risk Difference (RD)|11.5||||0.0499|TWO_SIDED|95.0|-0.99|23.38|||Cochran-Mantel-Haenszel|||||23.38|-0.99|0.0499
91725763|NCT05156125|183346457|SUPERIORITY||Risk Difference (RD)|21.4||||0.0011|TWO_SIDED|95.0|7.94|33.53|||Cochran-Mantel-Haenszel|||At Week 13||33.53|7.94|0.0011
91725764|NCT05156125|183346458|SUPERIORITY|||||||0.0072|||||||Cochran-Mantel-Haenszel|||At Week 13||||0.0072
91725765|NCT05156125|183346458|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||At Week 13||||<0.0001
91725766|NCT02993302|183346471|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91725767|NCT02993302|183346472|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91725768|NCT02993302|183346473|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91725769|NCT00997126|183346479|SUPERIORITY_OR_OTHER|||||||0.657|||||||Chi-squared|||||||0.657
91725770|NCT01755637|183346480|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean Ratio of treatments|114.37|||||TWO_SIDED|90.0|100.49|130.16|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.16|100.49|
91695183|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 1|-1.0|||||TWO_SIDED|90.0|-5.13|2.66||||||||2.66|-5.13|
91695184|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 5|3.0|||||TWO_SIDED|90.0|-1.1|7.95||||||||7.95|-1.10|
91695185|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6A|-12.0|||||TWO_SIDED|90.0|-20.94|-2.97||||||||-2.97|-20.94|
91695186|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6B|-7.9|||||TWO_SIDED|90.0|-15.0|-1.01||||||||-1.01|-15.0|
91695187|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 7F|-3.0|||||TWO_SIDED|90.0|-7.95|1.1||||||||1.10|-7.95|
91695188|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 9V|-3.0|||||TWO_SIDED|90.0|-9.17|2.9||||||||2.90|-9.17|
91695189|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 14|1.0|||||TWO_SIDED|90.0|-4.0|6.27||||||||6.27|-4.00|
91695190|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19A|-5.9|||||TWO_SIDED|90.0|-12.38|0.17||||||||0.17|-12.38|
91695191|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19F|0.0|||||TWO_SIDED|90.0|-4.22|4.33||||||||4.33|-4.22|
91695192|NCT02308540|183285357|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 23F|-6.0|||||TWO_SIDED|90.0|-12.77|0.4||||||||0.40|-12.77|
91695193|NCT02308540|183285359|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 1|9.1|||||TWO_SIDED|90.0|-15.55|36.11||||||||36.11|-15.55|
91695194|NCT02308540|183285359|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 5|0.0|||||TWO_SIDED|90.0|-18.56|18.56||||||||18.56|-18.56|
91695195|NCT02308540|183285359|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 6B|5.0|||||TWO_SIDED|90.0|-12.35|22.97||||||||22.97|-12.35|
91695196|NCT02308540|183285359|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 14|5.3|||||TWO_SIDED|90.0|-12.15|24.01||||||||24.01|-12.15|
91695197|NCT02308540|183285359|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19A|-5.9|||||TWO_SIDED|90.0|-26.41|11.01||||||||11.01|-26.41|
91695198|NCT02308540|183285359|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19F|5.0|||||TWO_SIDED|90.0|-11.64|22.97||||||||22.97|-11.64|
91725771|NCT01755637|183346481|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|107.41|||||TWO_SIDED|90.0|69.03|167.13|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||167.13|69.03|
91725772|NCT01755637|183346482|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|111.28|||||TWO_SIDED|90.0|94.76|130.68|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.68|94.76|
91725773|NCT01755637|183346483|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0167||||0.0011||95.0|||||Wilcoxon signed rank test|The values were not adjusted for this non-parametric analysis.|The median difference was calculated as = (Experimental-Reference)|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.0011
91490246|NCT01663532|182852911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
91695199|NCT01421225|183285414|EQUIVALENCE|The null hypothesis was that the number of hours would be the same (no effect of control).|Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|||||Statistical analysis was performed using a paired t-test.|t-test, 2 sided|||We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)||||0.12
91695200|NCT01814696|183285420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.605||||||a prior threshold p\<0.05|Fisher Exact|||||||0.605
91695201|NCT01814696|183285421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604|TWO_SIDED||||||Fisher Exact|||Heart failure related ED visits||||0.604
91695202|NCT01814696|183285421|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||Non-heart failure related ED visits||||1.000
91695203|NCT01814696|183285421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||All cause ED visits||||0.677
91695204|NCT01814696|183285422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.341|TWO_SIDED||||||Fisher Exact|||||||0.341
91695205|NCT01814696|183285422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Fisher Exact|||||||0.042
91695206|NCT01814696|183285423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.497
91725774|NCT01755637|183346484|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|112.05|||||TWO_SIDED|90.0|103.65|121.12|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||121.12|103.65|
91725775|NCT01755637|183346485|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|113.1|||||TWO_SIDED|90.0|103.4|123.71|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||123.71|103.40|
91725776|NCT01755637|183346486|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|114.33|||||TWO_SIDED|90.0|102.99|126.93|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||126.93|102.99|
91725777|NCT03338023|183346501|NON_INFERIORITY|Noninferiority of LY2963016 to Lantus® was demonstrated at the 0.4% noninferiority margin and over 80 percent power.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
91725778|NCT03338023|183346502|NON_INFERIORITY|Noninferiority of Lantus® to LY2963016 was demonstrated at the 0.4% noninferiority margin.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
91725779|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-6.8||||0.191|TWO_SIDED|95.0|-17.0|3.4|||Mixed Models Analysis|||Before Morning Meal Glucose||3.4|-17.0|0.191
91725780|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-7.8||||0.25|TWO_SIDED|95.0|-21.2|5.5|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||5.5|-21.2|0.250
91490247|NCT01663532|182852911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
91725781|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-13.1||||0.028|TWO_SIDED|95.0|-24.7|-1.5|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||-1.5|-24.7|0.028
91725782|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-3.6||||0.599|TWO_SIDED|95.0|-16.8|9.7|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||9.7|-16.8|0.599
91725783|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-11.0||||0.109|TWO_SIDED|95.0|-24.4|2.5|||Mixed Models Analysis|||Before Evening Meal Glucose||2.5|-24.4|0.109
91725784|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-5.4||||0.452|TWO_SIDED|95.0|-19.4|8.6|||Mixed Models Analysis|||Bedtime Glucose||8.6|-19.4|0.452
91695207|NCT01814696|183285423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.413
91695208|NCT01814696|183285423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.944|TWO_SIDED||||||Wilcoxon rank-sum test|||Non-heart failure ED visits||||0.944
91725785|NCT03338023|183346503|SUPERIORITY||Mean Difference (Net)|-7.4||||0.18|TWO_SIDED|95.0|-18.3|3.5|||Mixed Models Analysis|||0300 Am Glucose||3.5|-18.3|0.180
91725786|NCT03338023|183346504|SUPERIORITY|||||||0.787|||||||Fisher Exact|||||||0.787
91725787|NCT03338023|183346505|SUPERIORITY|||||||0.201|||||||Fisher Exact|||||||0.201
91725788|NCT03338023|183346506|SUPERIORITY||Mean Difference (Net)|-0.3||||0.885|TWO_SIDED|95.0|-0.4|3.4|||Mixed Models Analysis|||||3.4|-0.4|0.885
91725789|NCT03338023|183346507|SUPERIORITY||Mean Difference (Net)|-3.5||||0.328|TWO_SIDED|95.0|-10.6|3.6|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||3.6|-10.6|0.328
91695209|NCT01814696|183285424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.057
91695210|NCT01814696|183285424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.236
91695211|NCT01814696|183285424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.236
91695212|NCT01814696|183285425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon rank-sum test|||All cause||||0.034
91695213|NCT01814696|183285425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|||||||Wilcoxon rank-sum test|||Heart failure related||||0.196
91695214|NCT01814696|183285425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.210
91695215|NCT01814696|183285426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
91695216|NCT02105987|183285450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -10%.|Mean Difference (Net)|-3.4|||||TWO_SIDED|95.0|-9.1|2.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||2.4|-9.1|
91695217|NCT02105987|183285452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.0|1.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||1.4|-2.0|
91695218|NCT02105987|183285457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.096|TWO_SIDED|95.0|-0.02|0.23|||ANCOVA||Statistical analysis of cholesterol is presented|||0.23|-0.02|0.096
91695219|NCT02105987|183285457|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07||||0.167|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||Statistical analysis of LDL cholesterol is presented|||0.18|-0.03|0.167
91695220|NCT02105987|183285457|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.317|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA||Statistical analysis of HDL cholesterol is presented|||0.06|-0.02|0.317
91695221|NCT02105987|183285457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.187|TWO_SIDED|95.0|-0.05|0.27|||ANCOVA||Statistical analysis of triglycerides is presented|||0.27|-0.05|0.187
91725790|NCT03338023|183346507|SUPERIORITY||Mean Difference (Net)|-1.7||||0.467|TWO_SIDED|95.0|-6.5|3.0|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.0|-6.5|0.467
91725791|NCT03338023|183346508|SUPERIORITY||Mean Difference (Net)|-0.8||||0.09|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.090
91725792|NCT03338023|183346509|SUPERIORITY||Mean Difference (Net)|-1.2||||0.089|TWO_SIDED|95.0|-2.6|0.2|||Mixed Models Analysis|||||0.2|-2.6|0.089
91725793|NCT03338023|183346510|SUPERIORITY||Mean Difference (Net)|-0.1||||0.77|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.770
91725794|NCT03338023|183346511|SUPERIORITY||Mean Difference (Net)|-0.3||||0.879|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||ITSQ Inconvenience of Regimen Transformed Score||3.3|-3.9|0.879
91725795|NCT03338023|183346511|SUPERIORITY||Mean Difference (Net)|-0.7||||0.788|TWO_SIDED|95.0|-5.9|4.5|||ANCOVA|||ITSQ Lifestyle Flexibility Transformed Score||4.5|-5.9|0.788
91725796|NCT03338023|183346511|SUPERIORITY||Mean Difference (Net)|-0.6||||0.775|TWO_SIDED|95.0|-4.5|3.3|||ANCOVA|||ITSQ Hypoglycemic Control Transformed Score||3.3|-4.5|0.775
91725797|NCT03338023|183346511|SUPERIORITY||Mean Difference (Net)|1.0||||0.681|TWO_SIDED|95.0|-3.6|5.6|||ANCOVA|||ITSQ Glycemic Control Transformed Score||5.6|-3.6|0.681
91725798|NCT03338023|183346511|SUPERIORITY||Mean Difference (Net)|0.4||||0.819|TWO_SIDED|95.0|-3.1|3.9|||ANCOVA|||ITSQ Insulin Delivery Device Satisfaction Transformed Score||3.9|-3.1|0.819
91725799|NCT03338023|183346511|SUPERIORITY||Mean Difference (Net)|-0.8||||0.605|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|||ITSQ Total Transformed Score||2.3|-3.9|0.605
91725800|NCT02030418|183346541|SUPERIORITY|"The primary safety hypothesis is:~H0: CFR ≤ 86% vs. H1: CFR \> 86% Where CFR is the Complication Free Rate. The CFR is estimated as a binomial proportion and the 95% confidence interval (CI) of CFR is calculated using the Clopper-Pearson exact method. The null hypothesis is rejected at the 2.5% significance level if the lower bound of this CI exceeds the Performance Goal (PG) of 86%."|binomial proportion|93.3|||<|0.001|TWO_SIDED|95.0|89.9|95.9|||1-sided exact test for binomial proporti|||||95.9|89.9|<0.001
91725801|NCT02030418|183346542|SUPERIORITY|"The primary effectiveness hypothesis is:~H0: Rate ≤ 85.0% vs. H1: Rate \> 85.0%~where Rate is the proportion of subjects experiencing success, and success is defined as: pacing threshold voltage ≤ 2.0 V at 0.4 ms at 6-month visit and sensed R-wave amplitude either ≥ 5.0 mV at the 6-month visit or ≥ value at implant."|binomial proportion|93.4|||<|0.001|TWO_SIDED|95.0|89.9|96.0||The null hypothesis is rejected at the 2.5% significance level if the lower bound of the CI exceeds the Performance Goal (PG) of 85%.|1-sided exact test for binomial proporti|||||96.0|89.9|<0.001
91725802|NCT02030418|183346543|OTHER|"The hypothesis is intended to test whether the mean slope is within 35% of 1. The hypothesis is stated as follows:~H0: absolute value (Mean Slope - 100%) ≥ equivalence margin, equal to 35%~H1: absolute value (Mean Slope - 100%) \< equivalence margin, equal to 35%~The calculation of slope for individual subjects in the CAEP exercise protocol is done by setting the y-intercept to zero."|Slope|0.83|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|95.0|0.73|0.93|||two 1-sided test (TOST)|||||0.93|0.73|0.001
91725803|NCT00567112|183346593|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.92|1.05|||ANOVA|||OCT (fasted)/DFC (fasted)||1.05|0.92|>0.200
91725804|NCT00567112|183346594|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.8|1.19|||ANOVA|||OCT (fasted)/DFC (fasted)||1.19|0.80|>0.200
91725805|NCT00567112|183346595|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.92||||0.026|TWO_SIDED|90.0|0.86|0.98|||ANOVA|||OCT (after meal)/OCT (fasted)||0.98|0.86|0.026
91725806|NCT00567112|183346596|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.59|||<|0.001|TWO_SIDED|90.0|0.49|0.72|||ANOVA|||OCT (after meal)/OCT (fasted)||0.72|0.49|<0.001
91725807|NCT00567112|183346597|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
91725808|NCT00567112|183346598|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
91725809|NCT00567112|183346599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||OCT (after meal)/OCT (fasted)||||<0.001
91725810|NCT00567112|183346600|SUPERIORITY_OR_OTHER||||||>|0.2|||||||ANOVA|||OCT (after meal)/OCT (fasted)||||>0.200
91725811|NCT00762177|183346601|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725812|NCT00762177|183346602|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725813|NCT00762177|183346603|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725814|NCT00762177|183346604|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725815|NCT00762177|183346605|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725816|NCT00762177|183346606|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725817|NCT00762177|183346607|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725818|NCT00762177|183346608|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar||||0.05
91725819|NCT00762177|183346609|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725820|NCT00762177|183346610|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725821|NCT00762177|183346611|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725822|NCT00762177|183346612|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725823|NCT00762177|183346613|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725824|NCT00762177|183346614|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725825|NCT00762177|183346615|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725826|NCT00762177|183346616|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725827|NCT00762177|183346617|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725828|NCT00762177|183346618|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725829|NCT00762177|183346619|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725830|NCT00762177|183346620|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725831|NCT00762177|183346621|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725832|NCT00762177|183346622|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725833|NCT00762177|183346623|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725834|NCT00762177|183346624|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91725835|NCT04180696|183346644|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.||||||0.61|||||||Chi-squared|||||||0.61
91490248|NCT01663532|182852911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-1.1|<.0001
91490249|NCT01663532|182852912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.0006|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-2.1|0.0006
91725836|NCT04180696|183346645|SUPERIORITY||Odds Ratio (OR)|1.192|STANDARD_ERROR_OF_MEAN|0.367||0.63|TWO_SIDED|95.0|0.579|2.455|||Regression, Logistic|Proportional odds logistic regression model. Baseline NYHA class and time included as fixed covariates.||Due to limited number of subjects with NYHA class III or IV during follow-up, class III, IV, and death were grouped as a single category for analysis.||2.455|0.579|0.63
91725837|NCT04180696|183346646|SUPERIORITY||Hazard Ratio (HR)|1.25|STANDARD_ERROR_OF_MEAN|0.476||0.64|TWO_SIDED|95.0|0.492|3.175|||Regression, Cox|Adjusted for NYHA class and sex.||||3.175|0.492|0.64
91725838|NCT04180696|183346647|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
91725839|NCT04180696|183346648|SUPERIORITY||Hazard Ratio (HR)|1.02|STANDARD_ERROR_OF_MEAN|0.817||0.98|TWO_SIDED|95.0|0.206|5.056|||Regression, Cox|||||5.056|0.206|0.98
91725840|NCT04906421|183346662|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population analysis||||0.0018
91725841|NCT04906421|183346662|SUPERIORITY|||||||0.0035||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0035
91490250|NCT01663532|182852912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.3|<.0001
91725842|NCT04906421|183346662|SUPERIORITY|||||||0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|t-test, 1 sided|One-sided||mITT Population Analysis||||0.0001
91725843|NCT04906421|183346662|SUPERIORITY|||||||0.0003||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0003
91725844|NCT04906421|183346663|SUPERIORITY|||||||0.0087||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population Analysis||||0.0087
91725845|NCT04906421|183346663|SUPERIORITY|||||||0.0173||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0173
91725846|NCT04906421|183346663|SUPERIORITY|||||||0.0022||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||mITT Population Analysis||||0.0022
91725847|NCT04906421|183346663|SUPERIORITY|||||||0.0044||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0044
91725848|NCT04906421|183346664|SUPERIORITY|||||||0.0102|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0102
91725849|NCT04906421|183346664|SUPERIORITY|||||||0.59|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Fibrosis Stage F2 at Baseline Population Analysis||||0.59
91725850|NCT04906421|183346664|SUPERIORITY|||||||0.0032|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-Sided||Subgroup Fibrosis Stage F3 at Baseline Population Analysis||||0.0032
91725851|NCT04906421|183346664|SUPERIORITY|||||||0.0764|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Type 2 Diabetes Mellitus at Baseline Population Analysis||||0.0764
91725852|NCT04906421|183346665|SUPERIORITY|||||||0.0043||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0043
91725853|NCT04906421|183346666|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0018
91695222|NCT02105987|183285458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.175|TWO_SIDED|95.0|-0.04|0.25|||ANCOVA||Statistical analysis of total cholesterol/HDL cholesterol ratio is presented|||0.25|-0.04|0.175
91695223|NCT02105987|183285459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.5|||ANCOVA||Statistical analysis for total score is presented|||3.5|1.3|<0.001
91695224|NCT02105987|183285459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.002|TWO_SIDED|95.0|0.4|1.7|||ANCOVA||Statistical analysis for general satisfaction/clinical subscale score is presented|||1.7|0.4|0.002
91695225|NCT02105987|183285459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.8|||ANCOVA||Statistical analysis for lifestyle/ease subscale is presented|||1.8|0.8|<0.001
91695226|NCT02105987|183285460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51|||<|0.001|TWO_SIDED|95.0|4.86|8.16|||ANCOVA|||||8.16|4.86|<0.001
91695227|NCT02105987|183285461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|||<|0.001|TWO_SIDED|95.0|-8.64|-5.11|||ANCOVA|||||-5.11|-8.64|<0.001
91695228|NCT02105987|183285462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.17|-0.1|||ANCOVA|||||-0.10|-0.17|<0.001
91695229|NCT02105987|183285463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.375|TWO_SIDED|95.0|-0.31|0.12|||ANCOVA|||||0.12|-0.31|0.375
91695230|NCT02105987|183285464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.749|TWO_SIDED|95.0|-0.93|1.3|||ANCOVA|||||1.30|-0.93|0.749
91695231|NCT02105987|183285465|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.82|0.9||Bone specific alkaline phosphatase|ANCOVA|||||0.90|0.82|<0.001
91695232|NCT02105987|183285465|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.002|TWO_SIDED|95.0|0.85|0.96||Osteocalcin|ANCOVA|||||0.96|0.85|0.002
91695233|NCT02105987|183285465|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|-0.09||||0.001|TWO_SIDED|95.0|-0.15|-0.04||Procollagen 1 n-terminal propeptide|ANCOVA|||||-0.04|-0.15|0.001
91695234|NCT02105987|183285465|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96||Type I collagen c-telopeptides|ANCOVA|||||0.96|0.86|0.001
91695235|NCT02105987|183285466|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.57|0.72||Fatty acid binding protein 2|ANCOVA|||||0.72|0.57|<0.001
91695236|NCT02105987|183285466|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.08||||0.311|TWO_SIDED|95.0|0.93|1.24||Interleukin 6|ANCOVA|||||1.24|0.93|0.311
91695237|NCT02105987|183285466|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.96||Soluble CD14|ANCOVA|||||0.96|0.89|<0.001
91695238|NCT02105987|183285466|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.01||||0.742|TWO_SIDED|95.0|0.95|1.08||Soluble vasc cell adhesion molecule 1|ANCOVA|||||1.08|0.95|0.742
91695239|NCT02105987|183285467|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.999|TWO_SIDED|95.0|0.84|1.19|||ANCOVA|||||1.19|0.84|0.999
91695240|NCT02105987|183285468|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.981|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|||||1.10|0.91|0.981
91695241|NCT02105987|183285469|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.64|TWO_SIDED|95.0|0.85|1.11|||ANCOVA|||||1.11|0.85|0.640
91695242|NCT02105987|183285470|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.645|TWO_SIDED|95.0|0.87|1.09|||ANCOVA|||||1.09|0.87|0.645
91695243|NCT02105987|183285471|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.577|TWO_SIDED|95.0|0.97|1.06|||ANCOVA|||||1.06|0.97|0.577
91695244|NCT02105987|183285472|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.687|TWO_SIDED|95.0|0.98|1.03|||ANCOVA|||||1.03|0.98|0.687
91695245|NCT01303172|183285486|OTHER||Cox Proportional Hazard|0.54||||0.011|TWO_SIDED|95.0|0.33|0.87|||Log Rank|||The difference between the two treatment groups was tested with a two-sided log-rank test and a Cox regression model was used to estimate the hazard ratio (HR) and its 95% CI and associated p-value.||0.87|0.33|0.011
91695246|NCT02099110|183285506|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
91695247|NCT02099110|183285506|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||<|0.001|TWO_SIDED|95.0|-0.6|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.60|<0.001
91695248|NCT02099110|183285506|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.61|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.61|<0.001
91695249|NCT02099110|183285506|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
91695250|NCT02099110|183285507|SUPERIORITY_OR_OTHER||Difference in % vs Ertugliflozin 5 mg|-3.2|||||TWO_SIDED|95.0|-11.7|5.5|||||Based on Miettinen \& Nurminen method.|||5.5|-11.7|
91695251|NCT02099110|183285507|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|-1.9|||||TWO_SIDED|95.0|-10.6|6.8|||||Based on Miettinen \& Nurminen method.|||6.8|-10.6|
91695252|NCT02099110|183285507|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|1.4|||||TWO_SIDED|95.0|-7.4|10.1|||||Based on Miettinen \& Nurminen method.|||10.1|-7.4|
91695253|NCT02099110|183285507|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|-1.8|||||TWO_SIDED|95.0|-10.5|7.0|||||Based on Miettinen \& Nurminen method.|||7.0|-10.5|
91695254|NCT02099110|183285508|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 5 mg|0.1|||||TWO_SIDED|95.0|-3.3|3.6|||||Based on Miettinen \& Nurminen method.|||3.6|-3.3|
91695255|NCT02099110|183285508|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|0.5|||||TWO_SIDED|95.0|-3.0|4.0|||||Based on Miettinen \& Nurminen method.|||4.0|-3.0|
91695256|NCT02099110|183285508|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.5|||||TWO_SIDED|95.0|-2.9|3.9|||||Based on Miettinen \& Nurminen method.|||3.9|-2.9|
91695257|NCT02099110|183285508|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.9|||||TWO_SIDED|95.0|-2.5|4.4|||||Based on Miettinen \& Nurminen method.|||4.4|-2.5|
91725854|NCT04906421|183346667|SUPERIORITY||||||<|0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||<0.0001
91725855|NCT00990769|183346693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.0|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.||||>0.05
91725856|NCT01214720|183346699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.86|||Log Rank|||||0.86|0.61|0.0002
91725857|NCT01214720|183346700|SUPERIORITY_OR_OTHER||Difference in Response Rates|3.62||||0.3621|TWO_SIDED|95.0|-4.3|11.6|||Chi-squared|Approximate 95% confidence interval (CI) for difference of two rates using Hauck-Anderson method.||||11.6|-4.3|0.3621
91725858|NCT01214720|183346701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2087||95.0|0.74|1.07|||Log Rank|||||1.07|0.74|0.2087
91725859|NCT04625972|183346703|SUPERIORITY||Relative Risk Reduction|33.31||||0.212|TWO_SIDED|95.0|-25.92|64.68|||Poisson regression||Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||64.68|-25.92|0.212
91725860|NCT04625972|183346703|SUPERIORITY||Relative Risk Reduction|43.28||||0.044|TWO_SIDED|95.0|1.4|67.37|||Poisson regression||Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||67.37|1.40|0.044
91725861|NCT04625972|183346705|SUPERIORITY||Relative Risk Reduction|100.0||||0.664|ONE_SIDED|97.5|-1836.98||||Poisson regression||||||-1836.98|0.664
91725862|NCT04625972|183346706|SUPERIORITY||Relative Risk Reduction|13.9||||0.163|TWO_SIDED|95.0|-6.23|30.21|||Poisson regression|||||30.21|-6.23|0.163
91725863|NCT04625972|183346708|SUPERIORITY||Relative Risk Reduction|25.75||||0.744|TWO_SIDED|95.0|-343.53|87.57|||Poisson regression|||||87.57|-343.53|0.744
91725864|NCT00433290|183346716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
91725865|NCT00433290|183346716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
91725866|NCT00433290|183346716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
91725867|NCT00433290|183346717|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||ANCOVA|Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.||||||0.164
91725868|NCT00433290|183346718|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline (change = endpoint - baseline)|ANCOVA|Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.016
91725869|NCT00433290|183346719|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.068
91725870|NCT00433290|183346720|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.064
91725871|NCT00433290|183346721|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.008
91725872|NCT00433290|183346721|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.047
91725873|NCT00433290|183346722|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.009
91725874|NCT00433290|183346723|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91725875|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.897
91725876|NCT00433290|183346724|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||<0.001
91725877|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.004
91725878|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for General Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.051
91725879|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.508
91725880|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.019
91725881|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.415
91725882|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.006
91725883|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.342
91725884|NCT00433290|183346724|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.135
91725885|NCT00433290|183346725|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.||||||0.209
91725886|NCT00433290|183346726|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.871
91725887|NCT00433290|183346727|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.138
91725888|NCT00433290|183346728|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.003
91725889|NCT00433290|183346729|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.015
91725890|NCT00433290|183346730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||<0.001
91725891|NCT00433290|183346730|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.|Regression, Linear|||Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1\*treatment group+a2\*change in BDI total+a3\*change in HADS-A+a4\*BL of BPI average pain+a5\*BL of BDI total+a6\*BL of HADS-A.||||0.002
91725892|NCT00433290|183346731|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Change from Baseline. Change=Endpoint minus baseline.|ANCOVA|||||||0.007
91725893|NCT00433290|183346732|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.050
91528179|NCT01108510|182931603|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was \> -12%.|Difference in percentages|-2.2|||||TWO_SIDED|95.2|-7.4|3.0|||||Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.||3.0|-7.4|
91725894|NCT00433290|183346733|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.913
91725895|NCT00433290|183346734|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.066
91725896|NCT00433290|183346735|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.001
91725897|NCT00433290|183346736|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.260
91725898|NCT00433290|183346737|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.489
91725899|NCT00433290|183346738|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.131
91725900|NCT00433290|183346739|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.082
91725901|NCT00433290|183346741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
91725902|NCT00433290|183346741|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for AST Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.010
91725903|NCT00433290|183346741|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for GGT Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.023
91725904|NCT00433290|183346742|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.042
91725905|NCT00433290|183346743|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.005
91725906|NCT00433290|183346744|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value for SBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.285
91725907|NCT00433290|183346744|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for DBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.668
91725908|NCT00433290|183346745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
91725909|NCT00433290|183346746|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||||||0.040
91725910|NCT00504309|183346755|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|Tukey p-values were used for post hoc comparisons.||Fasting triglycerides (mg/dL) were measured on two consecutive days and averaged for analysis at the end of each treatment period. The null hypothesis was that triglycerides did not differ between groups.||||0.002
91725911|NCT00504309|183346755|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||Cholesterol values were compared as the average of two fasting values at the end of each treatment. Cholesterol values included LDL-C, HDL-C, total cholesterol, and calculated ratios.||||> 0.05
91725912|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.77|||||TWO_SIDED|95.0|1.3|2.4||||||1 min post bolus (Bolus time: 3 hours)||2.40|1.30|
91725913|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.91|||||TWO_SIDED|95.0|1.42|2.59||||||1 min post bolus (Bolus time: 3 hours)||2.59|1.42|
91725914|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.37|2.49||||||1 min post bolus (Bolus time: 3 hours)||2.49|1.37|
91725915|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.42|||||TWO_SIDED|95.0|1.05|1.92||||||1 min post bolus (Bolus time: 3 hours)||1.92|1.05|
91725916|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.08|||||TWO_SIDED|95.0|0.8|1.46||||||1 min post bolus (Bolus time: 3 hours)||1.46|0.80|
91725917|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||1 min post bolus (Bolus time: 3 hours)||1.41|0.77|
91725918|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.08||||||1 min post bolus (Bolus time: 3 hours)||1.08|0.59|
91725919|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.96|||||TWO_SIDED|95.0|0.72|1.3||||||1 min post bolus (Bolus time: 3 hours)||1.30|0.72|
91725920|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||1 min post bolus (Bolus time: 3 hours)||1.00|0.55|
91725921|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.77|||||TWO_SIDED|95.0|0.57|1.04||||||1 min post bolus (Bolus time: 3 hours)||1.04|0.57|
91725922|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.09|2.02||||||1 min post bolus (Bolus time: 6 hours)||2.02|1.09|
91725923|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.68|||||TWO_SIDED|95.0|1.25|2.28||||||1 min post bolus (Bolus time: 6 hours)||2.28|1.25|
91725924|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.36|2.48||||||1 min post bolus (Bolus time: 6 hours)||2.48|1.36|
91725925|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.16|||||TWO_SIDED|95.0|0.85|1.56||||||1 min post bolus (Bolus time: 6 hours)||1.56|0.85|
91528180|NCT01108510|182931604|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-1.4|||||TWO_SIDED|95.0|-7.6|4.7|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.7|-7.6|
91725926|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.13|||||TWO_SIDED|95.0|0.83|1.54||||||1 min post bolus (Bolus time: 6 hours)||1.54|0.83|
91725927|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.24|||||TWO_SIDED|95.0|0.91|1.68||||||1 min post bolus (Bolus time: 6 hours)||1.68|0.91|
91725928|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.05||||||1 min post bolus (Bolus time: 6 hours)||1.05|0.57|
91725929|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.09|||||TWO_SIDED|95.0|0.81|1.47||||||1 min post bolus (Bolus time: 6 hours)||1.47|0.81|
91725930|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.69|||||TWO_SIDED|95.0|0.51|0.93||||||1 min post bolus (Bolus time: 6 hours)||0.93|0.51|
91725931|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.85||||||1 min post bolus (Bolus time: 6 hours)||0.85|0.47|
91725932|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.03||||||1 min post bolus (Bolus time: 9 hours)||2.03|1.10|
91725933|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.96|||||TWO_SIDED|95.0|1.45|2.65||||||1 min post bolus (Bolus time: 9 hours)||2.65|1.45|
91725934|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|2.03|||||TWO_SIDED|95.0|1.5|2.74||||||1 min post bolus (Bolus time: 9 hours)||2.74|1.50|
91725935|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||1 min post bolus (Bolus time: 9 hours)||1.69|0.93|
91725936|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.31|||||TWO_SIDED|95.0|0.97|1.78||||||1 min post bolus (Bolus time: 9 hours)||1.78|0.97|
91725937|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.36|||||TWO_SIDED|95.0|1.01|1.84||||||1 min post bolus (Bolus time: 9 hours)||1.84|1.01|
91725938|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.84|||||TWO_SIDED|95.0|0.62|1.14||||||1 min post bolus (Bolus time: 9 hours)||1.14|0.62|
91725939|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.4||||||1 min post bolus (Bolus time: 9 hours)||1.40|0.77|
91725940|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||1 min post bolus (Bolus time: 9 hours)||0.86|0.47|
91725941|NCT05067270|183346768|OTHER||Geometric Least Squares Mean Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.83||||||1 min post bolus (Bolus time: 9 hours)||0.83|0.46|
91725942|NCT00983957|183346795|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.105|||||TWO_SIDED|90.0|1.023|1.195|||||Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.195|1.023|
91725943|NCT00983957|183346796|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.071|||||TWO_SIDED|90.0|0.988|1.16|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.160|0.988|
91725944|NCT00983957|183346797|SUPERIORITY_OR_OTHER||Adjusted geometric mean|1.009|||||TWO_SIDED|90.0|0.951|1.07|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.070|0.951|
91725945|NCT00983957|183346798|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.121|||||TWO_SIDED|90.0|1.018|1.234|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.234|1.018|
91725946|NCT00983957|183346801|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.059|||||TWO_SIDED|90.0|0.988|1.135|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.135|0.988|
91725947|NCT00983957|183346806|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.115|||||TWO_SIDED|90.0|1.063|1.171|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.171|1.063|
91725948|NCT01560416|183346808|SUPERIORITY|||||||0.79|||||||Log Rank|||||||0.79
91725949|NCT01560416|183346810|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
91725950|NCT05894564|183346813|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.88|1.1|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.10|0.88|
91725951|NCT05894564|183346814|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.65|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||5.65|0.05|
91725952|NCT05894564|183346817|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.28|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.28|0.31|
91725953|NCT05894564|183346818|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.56|1.87|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.87|0.56|
91725954|NCT05894564|183346819|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.25|1.16|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.16|0.25|
91725955|NCT05894564|183346820|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.33|1.74|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.74|0.33|
91725956|NCT05894564|183346821|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.71|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.21|0.71|
91695258|NCT02099110|183285509|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.48|-1.22||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.22|-2.48|<0.001
91695259|NCT02099110|183285509|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.27|||<|0.001|TWO_SIDED|95.0|-2.9|-1.64||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained logitudinal data analysis|||||-1.64|-2.90|<0.001
91695260|NCT02099110|183285510|SUPERIORITY_OR_OTHER||Difference in the least squares means|-8.23||||0.004|TWO_SIDED|95.0|-13.82|-2.65||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-2.65|-13.82|0.004
91695261|NCT02099110|183285510|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.79|||<|0.001|TWO_SIDED|95.0|-17.35|-6.23||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-6.23|-17.35|<0.001
91695262|NCT02099110|183285510|SUPERIORITY_OR_OTHER||Difference in the least squares means|-18.4|||<|0.001|TWO_SIDED|95.0|-24.03|-12.77||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-12.77|-24.03|<0.001
91695263|NCT02099110|183285510|SUPERIORITY_OR_OTHER||Difference in the least squares means|-23.14|||<|0.001|TWO_SIDED|95.0|-28.76|-17.53||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-17.53|-28.76|<0.001
91695264|NCT02099110|183285511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.001|TWO_SIDED|95.0|2.68|6.4||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||6.40|2.68|<0.001
91695265|NCT02099110|183285511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||<|0.001|TWO_SIDED|95.0|1.68|3.83||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||3.83|1.68|<0.001
91695266|NCT02099110|183285511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.92|4.54||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||4.54|1.92|<0.001
91695267|NCT02099110|183285511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|95.0|1.69|3.89|||Regression, Logistic|Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.||||3.89|1.69|<0.001
91695268|NCT02099110|183285512|SUPERIORITY_OR_OTHER||Difference in the least squares means|7.61||||0.155|TWO_SIDED|95.0|-2.9|18.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||18.13|-2.90|0.155
91695269|NCT02099110|183285512|SUPERIORITY_OR_OTHER||Difference in the least squares means|-4.87||||0.369|TWO_SIDED|95.0|-15.54|5.8||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.80|-15.54|0.369
91695270|NCT02099110|183285512|SUPERIORITY_OR_OTHER||Difference in the least squares means|1.81||||0.734|TWO_SIDED|95.0|-8.66|12.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||12.27|-8.66|0.734
91695271|NCT02099110|183285512|SUPERIORITY_OR_OTHER||Difference in the least squares means|-9.59||||0.075|TWO_SIDED|95.0|-20.17|0.98||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the least squares means|||||0.98|-20.17|0.075
91695272|NCT02099110|183285513|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.76||||0.005|TWO_SIDED|95.0|-4.69|-0.83||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.83|-4.69|0.005
91695273|NCT02099110|183285513|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.01||||0.002|TWO_SIDED|95.0|-4.94|-1.09||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.09|-4.94|0.002
91695274|NCT00961350|183285578|SUPERIORITY_OR_OTHER||Proportions|3.8||||0.02||95.0|1.8|6.8|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||6.8|1.8|0.020
91695275|NCT00961350|183285579|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
91695276|NCT00961350|183285580|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
91695277|NCT00961350|183285581|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
91725957|NCT05894564|183346821|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.67|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.19|0.67|
91725958|NCT05894564|183346821|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.61|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.19|0.61|
91725959|NCT05894564|183346821|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.61|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.61|
91725960|NCT05894564|183346821|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.7|1.49|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.49|0.70|
91725961|NCT05894564|183346822|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.80|
91725962|NCT05894564|183346822|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.77|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.26|0.77|
91725963|NCT05894564|183346822|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.67|
91725964|NCT05894564|183346822|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.77|
91725965|NCT05894564|183346822|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.76|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.33|0.76|
91725966|NCT05894564|183346823|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.65|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.09|0.65|
91725967|NCT05894564|183346823|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
91725968|NCT05894564|183346823|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.21|0.64|
91725969|NCT05894564|183346823|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.87|1.73|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.73|0.87|
91725970|NCT05894564|183346823|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.85|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.64|0.85|
91725971|NCT05894564|183346824|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.74|
91725972|NCT05894564|183346824|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.59|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.10|0.59|
91725973|NCT05894564|183346824|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.59|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.59|
91725974|NCT05894564|183346824|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.83|1.62|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.62|0.83|
91725975|NCT05894564|183346824|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.34|0.70|
91725976|NCT05894564|183346825|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.79|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.34|0.79|
91725977|NCT05894564|183346825|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
91725978|NCT05894564|183346825|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.64|
91725979|NCT05894564|183346825|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.34|0.70|
91725980|NCT05894564|183346825|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.64|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.25|0.64|
91725981|NCT05894564|183346826|OTHER||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.61|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.01|0.61|
91725982|NCT05894564|183346826|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.64|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.11|0.64|
91725983|NCT05894564|183346826|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.63|
91725984|NCT05894564|183346826|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.6|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.12|0.60|
91725985|NCT05894564|183346826|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.67|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.24|0.67|
91725986|NCT05894564|183346827|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.81|
91725987|NCT05894564|183346827|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.18|0.76|
91725988|NCT05894564|183346827|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.72|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.72|
91725989|NCT05894564|183346827|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.79|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.79|
91725990|NCT05894564|183346827|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.64|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.01|0.64|
91725991|NCT05894564|183346828|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.17|||||TWO_SIDED|95.0|-0.56|0.26|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.26|-0.56|
91725992|NCT05894564|183346829|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.21|||||TWO_SIDED|95.0|-0.29|0.68|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.68|-0.29|
91725993|NCT00758043|183346855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|4.5|||||TWO_SIDED|95.0|-2.1|11.1||||||Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.||11.1|-2.1|
91725994|NCT00758043|183346855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.2||||||SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.||8.2|-4.3|
91725995|NCT00758043|183346856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Difference in Proportion|-0.5|||||TWO_SIDED|95.0|-7.7|6.8||||||||6.8|-7.7|
91725996|NCT00758043|183346856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.49|1.82||||||||1.82|0.49|
91725997|NCT03197935|183346870|SUPERIORITY||Absolute difference in pCR rate|16.5||||0.0044|TWO_SIDED|95.0|5.91|27.1||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).||27.10|5.91|0.0044
91725998|NCT03197935|183346871|SUPERIORITY||Difference in pCR|19.5||||0.0206|TWO_SIDED|95.0|4.17|34.83||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||34.83|4.17|0.0206
91725999|NCT03197935|183346872|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.21|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.21|0.47|
91726000|NCT03197935|183346873|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.26|1.18|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.18|0.26|
91726001|NCT03197935|183346874|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.44|1.3|||Stratified log-rank test|||Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).||1.30|0.44|
91726002|NCT03197935|183346875|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.23|1.43|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.43|0.23|
91726003|NCT03197935|183346876|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.3|1.04|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.04|0.30|
91726004|NCT03197935|183346877|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.91|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.91|0.26|
91726005|NCT03593629|183346884|NON_INFERIORITY|Non-inferiority margin was defined as -10%|Risk Difference (RD)|2.37|||||ONE_SIDED|95.0|-5.05||||||||||-5.05|
91726006|NCT03593629|183346885|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-2.6|||||ONE_SIDED|95.0|-8.88||||||||||-8.88|
91726007|NCT03593629|183346886|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-1.15|||||ONE_SIDED|95.0|-6.89||||||||||-6.89|
91726008|NCT00669331|183346947|SUPERIORITY_OR_OTHER||Rate Ratio Mannitol:Control|0.92||||0.3115|TWO_SIDED|95.0|0.78|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline PE rate as predictors and log of follow-up time as an offset variable|For rate ratio, Mannitol rate is the numerator, Control rate is the denominator|||1.08|0.78|0.3115
91726009|NCT00669331|183346948|SUPERIORITY_OR_OTHER||LS mean difference across the 52 weeks|-2.4||||0.0457|TWO_SIDED|95.0|-4.76|-0.05|||Mixed model repeated measures analysis|Model included treatment, visit, treatment\*visit, region and baseline SGRQ Total score.|difference calculated Mannitol-control. Negative difference is in favour of mannitol since lower scores indicate improved quality of life.|||-0.05|-4.76|0.0457
91726010|NCT00669331|183346949|SUPERIORITY_OR_OTHER||Rate ratio|0.91||||0.2754|TWO_SIDED|95.0|0.77|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline pulmonary exacerbation rate as predictors, log follow-up as offset|Rate ratio is for mannitol vs control.|||1.08|0.77|0.2754
91726011|NCT00669331|183346950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0218|TWO_SIDED|95.0|0.63|0.96|||Regression, Cox|Cox regression model was stratified by region and baseline PE rate||||0.96|0.63|0.0218
91726012|NCT00669331|183346951|SUPERIORITY_OR_OTHER||Rate ratio|0.88||||0.3602|TWO_SIDED|95.0|0.67|1.16|||Negative binomial model|treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||Analysed using a negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||1.16|0.67|0.3602
91726013|NCT00669331|183346952|SUPERIORITY_OR_OTHER||ls mean difference across 52 weeks|2.76||||0.0355|TWO_SIDED|95.0|0.19|5.33|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline sputum weight (g).|Difference mannitol-control|||5.33|0.19|0.0355
91695278|NCT00961350|183285582|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
91695279|NCT03867201|183285583|SUPERIORITY||Mean Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.64||0.015|TWO_SIDED|95.0|-2.83|-0.3|||Mixed Models Analysis|||||-0.30|-2.83|0.015
91695280|NCT02986282|183285591|OTHER||Median Difference (Final Values)|-0.0600326|||<|0.05|TWO_SIDED|95.0|-0.0799661|-0.0449876|||Wilcoxon (Mann-Whitney)|||It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.||-0.0449876|-0.0799661|<0.05
91695281|NCT02986282|183285592|OTHER||Median Difference (Final Values)|-0.0249837|||<|0.05|TWO_SIDED|95.0|-0.039992|-0.0100226|||Wilcoxon (Mann-Whitney)|||||-0.0100226|-0.039992|<0.05
91695282|NCT03467217|183285595|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.95|TWO_SIDED|95.0|-30.6|32.7|||ANCOVA|Adjusted for baseline value of ALT.||||32.7|-30.6|.95
91695283|NCT03467217|183285596|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.56|TWO_SIDED|95.0|-11.0|6.0|||ANCOVA|Adjusted for baseline value of GGT.||||6.0|-11.0|0.56
91695284|NCT03467217|183285597|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.53|TWO_SIDED|95.0|-10.3|19.8|||ANCOVA|Adjusted for the baseline AST value.||||19.8|-10.3|0.53
91695285|NCT03467217|183285598|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.57|TWO_SIDED|95.0|-20.8|37.5|||ANCOVA|Adjusted for the baseline ALT value.||||37.5|-20.8|0.57
91695286|NCT03467217|183285599|SUPERIORITY|Adjusted for the baseline ALT value.|Mean Difference (Final Values)|11.6||||0.25|TWO_SIDED|95.0|9.7|36.7|||ANCOVA|||||36.7|9.7|0.25
91695287|NCT03467217|183285600|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.0|6.8|||ANCOVA|Adjusted for the baseline HOMA-IR value.||||6.8|0.0|0.05
91695288|NCT03467217|183285601|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.64|TWO_SIDED|95.0|-1.5|2.5|||ANCOVA|Adjusted for the baseline weight value.||||2.5|-1.5|0.64
91695289|NCT03467217|183285602|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|Adjusted for the baseline BMI value.||||0.6|-0.6|0.98
91695290|NCT03467217|183285603|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.1|TWO_SIDED|95.0|-0.5|5.3|||ANCOVA|Adjusted for the baseline waist circumference value.||||5.3|-0.5|0.10
91695291|NCT03467217|183285604|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.08|TWO_SIDED|95.0|0.0|0.05|||ANCOVA|Adjusted for the baseline waist-to-hip ratio.||||0.05|0.00|0.08
91695292|NCT03467217|183285605|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.29|TWO_SIDED|95.0|-2.8|9.0|||ANCOVA|Adjusted for the baseline PedsQOL Physical Health score.||||9.0|-2.8|0.29
91695293|NCT03467217|183285606|SUPERIORITY|||||||0.17|||||||Exact conditional binomial test|||||||0.17
91695294|NCT03467217|183285607|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.64|TWO_SIDED|95.0|-13.9|8.7|||ANCOVA|Adjusted for baseline total cholesterol value.||||8.7|-13.9|0.64
91695295|NCT03467217|183285608|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.67|TWO_SIDED|95.0|-25.6|39.7|||ANCOVA|Adjusted for baseline triglyceride value.||||39.7|-25.6|0.67
91695296|NCT03467217|183285609|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.45|TWO_SIDED|95.0|-3.4|1.5|||ANCOVA|Adjusted for baseline HDL cholesterol value.||||1.5|-3.4|0.45
91695297|NCT03467217|183285610|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.93|TWO_SIDED|95.0|-10.3|9.4|||ANCOVA|Adjusted for baseline LDL cholesterol value.||||9.4|-10.3|0.93
91695298|NCT03467217|183285611|SUPERIORITY||Median Difference (Final Values)|2.9||||0.29|TWO_SIDED|95.0|-2.5|20.1|||ANCOVA|Adjusted for baseline PedsQOL Psychosocial Health score.||||20.1|-2.5|0.29
91695299|NCT01113385|183285620|SUPERIORITY_OR_OTHER|||||||0.009||||||p value reflects the difference in mean FSPF pre vs post galactose treatment.|t-test, 2 sided|||||||0.009
91695300|NCT03233529|183285622|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.7|-3.1|<0.0001
91695301|NCT03233529|183285623|SUPERIORITY||Least Squares Mean Difference|-0.9906|STANDARD_ERROR_OF_MEAN|0.48404||0.042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0420
91695302|NCT03233529|183285624|SUPERIORITY||Least Squares Mean Difference|-0.5446|STANDARD_ERROR_OF_MEAN|0.37855||0.1519|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.1519
91695303|NCT03233529|183285625|SUPERIORITY||Least Squares Mean Difference|-1.1273|STANDARD_ERROR_OF_MEAN|0.32552||0.0007|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0007
91695304|NCT03233529|183285626|SUPERIORITY||Least Squares Mean Difference|-0.7612|STANDARD_ERROR_OF_MEAN|0.44266||0.0871|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0871
91695305|NCT03233529|183285627|SUPERIORITY||Least Squares Mean Difference|-1.3641|STANDARD_ERROR_OF_MEAN|0.48603||0.0055|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0055
91695306|NCT03233529|183285628|SUPERIORITY||Least Squares Mean Difference|-1.1246|STANDARD_ERROR_OF_MEAN|0.49359||0.0238|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0238
91695307|NCT03233529|183285629|SUPERIORITY||Least Squares Mean Difference|-1.9913|STANDARD_ERROR_OF_MEAN|0.68659||0.0042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0042
91695308|NCT03233529|183285636|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Crisaborole 2% was superior to vehicle if p-value was \<0.05.||-1.4|-2.7|< 0.0001
91726014|NCT00669331|183346953|SUPERIORITY_OR_OTHER||LS mean diff across post-baseline visits|-0.44||||0.1159|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline ESS score|Negative change indicates an improvement in ESS score. Difference calculated Mannitol - Control.|||0.11|-0.99|0.1159
91726015|NCT00669331|183346954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.56||||0.6677|TWO_SIDED|95.0|-27.01|42.13|||Mixed Models Analysis|Model of absolute change from baseline in FEV1. Model includes terms for treatment, visit, trt\*visit, region and baseline value|ls mean difference Mannitol-Control|||42.13|-27.01|0.6677
91490251|NCT01663532|182852912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.0|-4.3|<.0001
91695309|NCT03233529|183285637|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-1.3|< 0.0001
91726016|NCT00669331|183346961|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.0928|TWO_SIDED|95.0|0.34|1.09|||Negative binomial regression|||||1.09|0.34|0.0928
91726017|NCT01428713|183347005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|536.4|STANDARD_ERROR_OF_MEAN|162.12||0.01||||||P value \< 0.05 is considered significant in this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for TA|||||0.01
91726018|NCT01428713|183347005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|430.6|STANDARD_ERROR_OF_MEAN|157.35||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for COCP|||||0.03
91726019|NCT01428713|183347005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|5.08||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for TA|||||0.03
91695310|NCT03233529|183285637|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-1.4|< 0.0001
91695311|NCT03233529|183285638|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36||0.0188|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis||Comparison at Day 2|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.1|-1.6|0.0188
91695312|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0014|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis||Comparison at Day 3|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.4|-1.9|0.0014
91695313|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 4|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
91695314|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis||Comparison at Day 5|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.2|< 0.0001
91695315|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 6|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
91695316|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis||Comparison at Day 7|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.3|< 0.0001
91695317|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.1|-2.5|< 0.0001
91695318|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 9|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
91726020|NCT01428713|183347005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.75|STANDARD_ERROR_OF_MEAN|4.87||0.01|||||||Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP|||||0.01
91695319|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.3|||Mixed Models Analysis||Comparison at Day 10|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.3|-2.7|< 0.0001
91695320|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis||Comparison at Day 11|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.9|-2.3|< 0.0001
91695321|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.9|-1.5|||Mixed Models Analysis||Comparison at Day 12|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.5|-2.9|< 0.0001
91695322|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 13|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
91726021|NCT00875667|183347010|SUPERIORITY||Stratified Hazard Ratio|0.63||||0.012|TWO_SIDED|95.0|0.43|0.9||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test|||||0.90|0.43|0.012
91726022|NCT00875667|183347011|SUPERIORITY||Stratified Hazard Ratio|0.6||||0.003|TWO_SIDED|95.0|0.43|0.85||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||The weights are based on observed events at the time the third DMC meeting was held and based on the difference between observed and expected events at the time of the primary analysis.|||0.85|0.43|0.003
91726023|NCT00875667|183347012|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91695323|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis||Comparison at Day 14|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.0|-2.4|< 0.0001
91695324|NCT03233529|183285638|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.2|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.7|< 0.0001
91695325|NCT01177293|183285644|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|89.78|||||TWO_SIDED|90.0|82.74|97.43||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||97.43|82.74|
91695326|NCT01177293|183285645|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric mean ratio|99.73|||||TWO_SIDED|90.0|85.1|116.87||||||||116.87|85.10|
91695327|NCT01177293|183285646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|86.67|||||TWO_SIDED|90.0|79.57|94.42||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||94.42|79.57|
91695328|NCT02237196|183285705|SUPERIORITY||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.5038||0.314|TWO_SIDED|95.0|-1.51|0.49|||Longitudinal repeated measures analysis|Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)||||0.49|-1.51|0.314
91695329|NCT02901067|183285717|SUPERIORITY|This is a secondary outcome thus no power analysis was done.|||||>|0.05|||||||Fisher Exact|||We hypothesized that the experimental group would present less fibrinolysis shutdown than the control group in all times measured.||||>0.05
91695330|NCT02901067|183285722|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91695331|NCT02901067|183285725|SUPERIORITY|||||||0.1|||||||Fisher Exact|||We hypothesized that the experimental group would have less pulmonary embolism events than the control group.||||0.10
91695332|NCT02901067|183285726|SUPERIORITY|||||||0.046|||||||Fisher Exact|||We hypothesized that the experimental group would have a lower incidence of venous thromboembolism (VTE) than the control group.||||0.046
91695333|NCT02049814|183285739|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established.||||||0.0001|||||||Paired t-test|||||||0.0001
91695334|NCT02307279|183285808|SUPERIORITY||Mean Difference (Net)|-2.07|STANDARD_ERROR_OF_MEAN|0.59||0.0007|TWO_SIDED|95.0|-3.24|-0.9|||ANCOVA|Adjusted for stratification factors, and baseline weight|Difference in adjusted mean taken for comparability between the two groups (treatment - placebo)|Simple Superiority, H0: μ (Placebo) -μ (Gelesis100) = 0||-0.90|-3.24|0.0007
91695335|NCT02307279|183285808|SUPERIORITY|||||||0.1193|||||||ANCOVA|Adjusted for stratification factors, and baseline weight||Super-Superiority (\>3% difference), H0: μ(Placebo)-μ(Gelesis100) \< 3%||||0.1193
91726024|NCT00875667|183347013|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726025|NCT00875667|183347014|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.421|TWO_SIDED|95.0|0.29|1.68|||Log Rank|||||1.68|0.29|0.421
91695336|NCT02307279|183285809|SUPERIORITY|The performance goal for body weight responders was set at 35%.|||||<|0.0001|||||||Binomial Proportion Test|||H0: π (Gelesis100)\< 0.35||||<0.0001
91695337|NCT02307279|183285809|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0008|TWO_SIDED|95.0|1.34|3.01|||Regression, Logistic|Adjusted for stratification factors and baseline weight||"OR-trt refers to the odds ratio of being a body weight responder for Gelesis100 vs. Placebo.~H0: OR-trt= 1."||3.01|1.34|0.0008
91695338|NCT01339923|183285841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.4|3.9|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.||3.9|-6.4|
91695339|NCT01339923|183285841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.2|7.6|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.||7.6|-5.2|
91695340|NCT00828568|183285859|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder's method with Yate's continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product.|Mean Difference (Final Values)|4.85||||||90.0|-5.37|15.08||||||||15.08|-5.37|
91695341|NCT00828568|183285861|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91695342|NCT00828568|183285861|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<.0001
91726026|NCT00875667|183347015|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.875|TWO_SIDED|95.0|0.52|1.74|||Log Rank|||||1.74|0.52|0.875
91726027|NCT00875667|183347016|SUPERIORITY|||||||0.313|||||||Chi-squared|||||||0.313
91726028|NCT00875667|183347017|SUPERIORITY|||||||0.465|||||||Chi-squared|||||||0.465
91726029|NCT00875667|183347018|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.005|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.005
91726030|NCT00875667|183347019|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.003|TWO_SIDED|95.0|0.46|0.86|||Log Rank|||||0.86|0.46|0.003
91695343|NCT00460811|183285863|SUPERIORITY_OR_OTHER|||||||0.0002|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0002
91695344|NCT00460811|183285863|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0036
91695345|NCT00460811|183285863|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||<0.0001
91695346|NCT00460811|183285863|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0008
91695347|NCT03515811|183285876|OTHER||Percentage and confidence interval|10.6|||||TWO_SIDED|95.0|5.0|19.2|||||95% CI: 5.0%-19.2%|||19.2|5.0|
91695348|NCT03515811|183285876|OTHER||Percentage and confidence interval|0.0|||||TWO_SIDED|95.0|0.0|7.0|||||95% CI: 0.0%-7.0%|||7.0|0.0|
91695349|NCT03515811|183285877|OTHER||Percentage and confidence interval|6.6|||||TWO_SIDED|95.0|3.1|12.2|||||95% CI: 3.1%-12.2%|||12.2|3.1|
91695350|NCT01197534|183285900|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
91726031|NCT00875667|183347020|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.046|TWO_SIDED|95.0|0.54|1.0|||Log Rank|||||1.00|0.54|0.046
91726032|NCT00875667|183347021|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.095|TWO_SIDED|95.0|0.58|1.05|||Log Rank|||||1.05|0.58|0.095
91726033|NCT00875667|183347022|SUPERIORITY||Hazard Ratio (HR)|3.91|||<|0.001|TWO_SIDED|95.0|1.95|7.85|||Log Rank|||||7.85|1.95|<0.001
91726034|NCT00875667|183347023|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.004|TWO_SIDED|95.0|1.24|3.42|||Log Rank|||||3.42|1.24|<0.004
91726035|NCT00875667|183347024|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.519|TWO_SIDED|95.0|0.62|1.28|||Log Rank|||||1.28|0.62|0.519
91726036|NCT00875667|183347025|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.558|TWO_SIDED|95.0|0.67|1.25|||Log Rank|||||1.25|0.67|0.558
91726037|NCT01967277|183347062|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||H0: µL ≤ µs Versus Ha: µL \> µs||||<0.001
91695351|NCT01197534|183285901|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.08|||<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.04|<0.001
91695352|NCT01197534|183285902|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.13|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.07|<0.001
91695353|NCT01197534|183285902|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.15|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.15|0.05|<0.001
91726038|NCT03300336|183347066|SUPERIORITY||Odds Ratio (OR)|0.77||||0.01|TWO_SIDED|95.0|0.64|0.93||a priori threshold for statistical significance p \<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline timepoints), and a site-level random effect. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||0.93|0.64|0.01
91726039|NCT03300336|183347067|SUPERIORITY||rate ratio|1.05||||0.25|TWO_SIDED|95.0|0.97|1.15||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a log link and negative binomial distribution.|The rate ratio compares the intervention rate in the numerator vs the usual care rate in the denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline time points), a site-level random effect and random effects for each of the time periods. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||1.15|0.97|0.25
91726040|NCT03300336|183347068|SUPERIORITY||Mean Difference (Net)|1.32||||0.52|TWO_SIDED|95.0|-2.7|5.33||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||5.33|-2.70|0.52
91695354|NCT01197534|183285903|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.1|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.10|0.03|<0.001
91726041|NCT03300336|183347069|SUPERIORITY||Mean Difference (Net)|1.56||||0.66|TWO_SIDED|95.0|-3.14|6.25||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||6.25|-3.14|0.66
91726042|NCT03300336|183347070|SUPERIORITY||Mean Difference (Net)|-0.52||||0.81|TWO_SIDED|95.0|-4.74|3.7||a priori threshold for significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect.. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 14 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.70|-4.74|0.81
91726043|NCT03300336|183347071|SUPERIORITY||Odds Ratio (OR)|1.13||||0.74|TWO_SIDED|95.0|0.55|2.32||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 0 out of 227 Missing data due to item nonresponse in intervention: 5 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||2.32|0.55|0.74
91726044|NCT03300336|183347072|SUPERIORITY||Mean Difference (Net)|0.02||||0.4|TWO_SIDED|95.0|-0.03|0.06||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 14 out of 227 Missing data due to item nonresponse in intervention: 33 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.06|-0.03|0.40
91726045|NCT03300336|183347073|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.07||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 7 out of 227 Missing data due to item nonresponse in intervention: 23 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.07|-0.01|0.18
91726046|NCT03300336|183347074|SUPERIORITY||Mean Difference (Net)|0.8||||0.83|TWO_SIDED|95.0|-6.38|7.98||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 4 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||7.98|-6.38|0.83
91726047|NCT03300336|183347075|SUPERIORITY||Mean Difference (Net)|1.46||||0.25|TWO_SIDED|95.0|-1.05|3.96||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention: 6 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.96|-1.05|0.25
91726048|NCT03300336|183347076|SUPERIORITY||Odds Ratio (OR)|1.16||||0.59|TWO_SIDED|95.0|0.68|1.99||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 3 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.99|0.68|0.59
91726049|NCT03300336|183347077|SUPERIORITY||Mean Difference (Net)|0.99||||0.47|TWO_SIDED|95.0|-1.71|3.69||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 11 out of 227 Missing data due to item nonresponse in intervention: 20 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.69|-1.71|0.47
91528181|NCT01108510|182931605|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-2.1|||||TWO_SIDED|95.0|-8.7|4.5|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.5|-8.7|
91528182|NCT01108510|182931606|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-22.2|6.3|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||6.3|-22.2|
91528183|NCT01108510|182931607|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-5.0||||0.67|TWO_SIDED|95.0|-28.0|18.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||18|-28|0.67
91726050|NCT03300336|183347078|SUPERIORITY||Mean Difference (Net)|-0.07||||0.94|TWO_SIDED|95.0|-1.76|1.62||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention group: 7 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.62|-1.76|0.94
91726051|NCT02384460|183347083|OTHER||Hazard Ratio (HR)|1.004||||0.985|TWO_SIDED|95.0|0.651|1.549||p-value is for Type 3 chi-square test for comparison between treatments.|Cox Model Analysis|||Cox proportional hazards model compares treatment groups with baseline target wound size, target wound age, and EB type as covariates.||1.549|0.651|0.985
91726052|NCT02384460|183347084|OTHER|Multiple imputation was implemented by 2 steps. The first step used Markov Chain Monte Carlo (MCMC) to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 010005 and the number of imputations was 5.|Odds Ratio (OR)|0.733||||0.39|TWO_SIDED|95.0|0.365|1.474||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Comparison between treatment groups of complete closure of target wound within 3 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.474|0.365|0.39
91726053|NCT02384460|183347085|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get the monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation method: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|1.633||||0.212|TWO_SIDED|95.0|0.758|3.517||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 1 visit. Comparison between treatment groups of complete closure of target wound within 1 month was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||3.517|0.758|0.212
91759998|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-8.68|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-8.68|
91759999|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.58|||||TWO_SIDED|95.0|-4.99|12.15||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.15|-4.99|
91760000|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.65|||||TWO_SIDED|95.0|6.38|24.93||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||24.93|6.38|
91760001|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.53|||||TWO_SIDED|95.0|-3.81|14.86||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.86|-3.81|
91760002|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-8.97|9.59||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.59|-8.97|
91760003|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||||TWO_SIDED|95.0|-4.69|13.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.77|-4.69|
91760004|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.65|||||TWO_SIDED|95.0|9.03|28.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||28.27|9.03|
91695355|NCT01197534|183285903|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.033|TWO_SIDED|95.0|0.0|0.07|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.00|0.033
91726054|NCT02384460|183347085|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|0.891||||0.802|TWO_SIDED|95.0|0.436|1.821||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 2 visit. Comparison between treatment groups of complete closure of target wound within 2 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.821|0.436|0.802
91726055|NCT02384460|183347086|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.682||||0.706|TWO_SIDED|95.0|-2.873|4.238||The p-value is calculated based on the hypothesis testing for the difference of least-squares (LS)-means between treatment and placebo.|Mixed Models Analysis|||Mixed Model Repeated Measures (MMRM) Analysis. The MMRM approach (using restricted maximum likelihood \[REML\] estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||4.238|-2.873|0.706
91726056|NCT02384460|183347087|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.128||||0.9|TWO_SIDED|95.0|-2.116|1.861||The p-value is calculated based on the hypothesis testing for the difference of LS-means between treatment and placebo.|Mixed Models Analysis|||MMRM Analysis. The MMRM approach (using REML estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||1.861|-2.116|0.9
91726057|NCT02384460|183347088|OTHER|Pre-specified.|Odds Ratio (OR)|1.445||||0.262|TWO_SIDED|95.0|0.759|2.752||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in itching versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline itching score, and EB type as covariates.||2.752|0.759|0.262
91726058|NCT02384460|183347089|OTHER|Pre-specified.|Odds Ratio (OR)|0.596||||0.098|TWO_SIDED|95.0|0.323|1.1||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in pain versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline pain score and EB type as covariates.||1.1|0.323|0.098
91726059|NCT01004393|183347106|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||ANOVA|||||||0.161
91726060|NCT02933476|183347112|SUPERIORITY||||||>|0.05|||||||ANOVA|||We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.||||>0.05
91726061|NCT02933476|183347113|SUPERIORITY|||||||0.008|||||||ANOVA|||||||0.008
91726062|NCT02933476|183347114|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91726063|NCT01179516|183347148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.488||0.597|TWO_SIDED|95.0|-3.71|2.14||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure for each dose was applied to compare 10 mg and 15 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||2.14|-3.71|0.597
91528184|NCT01108510|182931608|SUPERIORITY_OR_OTHER||Difference in LSM|-10.0||||0.51|TWO_SIDED|95.0|-38.0|19.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||19|-38|0.51
91726064|NCT01179516|183347148|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|1.501||0.745|TWO_SIDED|95.0|-3.44|2.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||2.46|-3.44|0.745
91726065|NCT01179516|183347149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.232||||0.396|TWO_SIDED|95.0|0.761|1.995|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.995|0.761|0.396
91726066|NCT01179516|183347149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.212||||0.435|TWO_SIDED|95.0|0.748|1.963|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.963|0.748|0.435
91726067|NCT01179516|183347150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.149||0.554|TWO_SIDED|95.0|-0.38|0.21|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.21|-0.38|0.554
91490252|NCT01663532|182852912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.6|-5.1|<.0001
91726068|NCT01179516|183347150|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.151||0.739|TWO_SIDED|95.0|-0.35|0.25|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.25|-0.35|0.739
91726069|NCT01179516|183347151|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|2.261||0.67|TWO_SIDED|95.0|-5.43|3.5|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||3.50|-5.43|0.670
91726070|NCT01179516|183347151|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.295||0.451|TWO_SIDED|95.0|-2.8|6.26|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||6.26|-2.80|0.451
91726071|NCT01179516|183347152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.291||||0.352|TWO_SIDED|95.0|0.754|2.211|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||2.211|0.754|0.352
91726072|NCT01179516|183347152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116||||0.694|TWO_SIDED|95.0|0.646|1.928|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||1.928|0.646|0.694
91726073|NCT01179516|183347153|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|1.25||0.464|TWO_SIDED|95.0|-3.38|1.55|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.55|-3.38|0.464
91726074|NCT01179516|183347153|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|1.322||0.6|TWO_SIDED|95.0|-1.91|3.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||3.30|-1.91|0.600
91726075|NCT01668537|183347154|NON_INFERIORITY|The non-inferiority margin to show that the FD formulation is non-inferior to the LF formulation in terms of ELISA GMTs at the peak visit (Week 6) was predefined as '1.5' for the GMT ratio (LF/FD). Non-inferiority is demonstrated if the upper 95% CI of the GMT ratio (LF/FD) is entirely below 1.5|GMT ratio (LF/FD)|0.796|||||TWO_SIDED|95.0|0.707|0.896||||||||0.896|0.707|
91726076|NCT02122952|183347181|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial Test|||Data for the current study were compared to historical control data (Pediatric Neuromuscular Clinical Research \[PNCR\], Finkel et al 2014 - PubMed 25080519) where 0 participants were able to sit independently.||||<0.001
91726077|NCT01659541|183347186|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons was made at various points in the study (Week #28, #40 and #52).||||<0.05
91726078|NCT01659541|183347187|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).||||<0.05
91726079|NCT01659541|183347188|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant)) were compared with data obtained after implantation (Week ##28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
91726080|NCT01659541|183347189|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
91726081|NCT01659541|183347190|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28 ,#40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. Paired t test. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
91726082|NCT01659541|183347191|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
91726083|NCT02184156|183347224|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91528185|NCT01108510|182931609|SUPERIORITY_OR_OTHER||Difference in LSM|-22.0||||0.18|TWO_SIDED|95.0|-54.0|10.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||10|-54|0.18
91726084|NCT02184156|183347225|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
91726085|NCT02405962|183347228|SUPERIORITY||Adjusted Incidence Rate Ratio|0.2|||<|0.05|TWO_SIDED|95.0|0.08|0.53|||Mixed Models Analysis|||||0.53|0.08|<0.05
91490253|NCT01663532|182852912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.4|-6.2|<.0001
91490254|NCT01663532|182852912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.7|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.7|-6.4|<.0001
91528186|NCT01108510|182931610|SUPERIORITY_OR_OTHER||Difference in LSM|6.0||||0.84|TWO_SIDED|95.0|-55.0|67.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||67|-55|0.84
91726086|NCT00086307|183347257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.018|TWO_SIDED|95.0|1.111|12.541||This is the omnibus effect of drug.|Mixed Models Analysis|||A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.||12.541|1.111|.018
91726087|NCT00086307|183347257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.014|TWO_SIDED|95.0|1.111|12.541||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.||12.541|1.111|.014
91726088|NCT00086307|183347257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.353|STANDARD_ERROR_OF_MEAN|2.296||0.454|TWO_SIDED|95.0|-2.36|9.066||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.||9.066|-2.360|.454
91726089|NCT00086307|183347257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.473|STANDARD_ERROR_OF_MEAN|2.162||0.349|TWO_SIDED|95.0|-1.942|8.888||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.||8.888|-1.942|.349
91726090|NCT03158311|183347263|NON_INFERIORITY|Non-inferiority margin: 0.25 points|Least Square mean (LS Mean)|-0.038|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.139|||P-Value is one-sided|Mixed Model for Repeated Measures (MMRM)||||||-0.139|<0.001
91726091|NCT03158311|183347263|NON_INFERIORITY|Non-inferiority margin: 0.25 points|LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.027|||P-Value is one-sided|MMRM||||||-0.027|<0.001
91726092|NCT03158311|183347264|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.025||0.892|TWO_SIDED|95.0|-0.046|0.052||P-value is two-sided|MMRM|||Week 8||0.052|-0.046|0.892
91726093|NCT03158311|183347264|SUPERIORITY||LS Mean|0.067|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.115||P-value is two-sided|MMRM|||Week 8||0.115|0.018|0.007
91726094|NCT03158311|183347264|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.945|TWO_SIDED|95.0|-0.05|0.047||P-value is two-sided|MMRM|||Week 16||0.047|-0.050|0.945
91726095|NCT03158311|183347264|SUPERIORITY||LS Mean|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.114||P-value is two-sided|MMRM|||Week 16||0.114|0.018|0.007
91726096|NCT03158311|183347264|SUPERIORITY||LS Mean|0.009|STANDARD_ERROR_OF_MEAN|0.026||0.713|TWO_SIDED|95.0|-0.041|0.06||P-value is two-sided|MMRM|||Week 24||0.060|-0.041|0.713
91726097|NCT03158311|183347264|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.026|<|0.001|TWO_SIDED|95.0|0.046|0.146||P-value is two-sided|MMRM|||Week 24||0.146|0.046|<0.001
91726098|NCT03158311|183347265|SUPERIORITY||LS Mean|-0.023|STANDARD_ERROR_OF_MEAN|0.046||0.308|TWO_SIDED|95.0|-0.113|0.067||P-value is one-sided|MMRM|||Week 16||0.067|-0.113|0.308
91726099|NCT03158311|183347265|SUPERIORITY||LS Mean|-0.079|STANDARD_ERROR_OF_MEAN|0.046||0.044|TWO_SIDED|95.0|-0.169|0.012||P-value is one-sided|MMRM|||Week 16||0.012|-0.169|0.044
91726100|NCT03158311|183347265|SUPERIORITY||LS Mean|-0.032|STANDARD_ERROR_OF_MEAN|0.047||0.245|TWO_SIDED|95.0|-0.125|0.06||P-value is one sided|MMRM|||Week 24||0.060|-0.125|0.245
91726101|NCT03158311|183347265|SUPERIORITY||LS Mean|-0.124|STANDARD_ERROR_OF_MEAN|0.047||0.004|TWO_SIDED|95.0|-0.216|-0.032||P-value is one sided|MMRM|||Week 24||-0.032|-0.216|0.004
91726102|NCT03158311|183347266|SUPERIORITY||LS Mean|0.018|STANDARD_ERROR_OF_MEAN|0.049||0.719|TWO_SIDED|95.0|-0.079|0.115||P-value is two-sided|MMRM|||||0.115|-0.079|0.719
91726103|NCT03158311|183347266|SUPERIORITY||LS Mean|0.082|STANDARD_ERROR_OF_MEAN|0.049||0.097|TWO_SIDED|95.0|-0.015|0.179||P-value is two-sided|MMRM|||||0.179|-0.015|0.097
91726104|NCT03158311|183347267|SUPERIORITY||Odds Ratio (OR)|1.23||||0.061|TWO_SIDED|95.0|0.94|1.61||P-value is one sided|Regression, Logistic|Logistic Regression Model via Generalized estimating equations (GEE)||||1.61|0.94|0.061
91726105|NCT03158311|183347267|SUPERIORITY||Odds Ratio (OR)|1.11||||0.227|TWO_SIDED|95.0|0.85|1.46||P-value is one-sided|Regression, Logistic|Logistic Regression Model via GEE||||1.46|0.85|0.227
91726106|NCT03158311|183347268|SUPERIORITY||Odds Ratio (OR)|1.17||||0.108|TWO_SIDED|95.0|0.91|1.49||P-value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.49|0.91|0.108
91726107|NCT03158311|183347268|SUPERIORITY||Odds Ratio (OR)|1.33||||0.013|TWO_SIDED|95.0|1.03|1.7||P-Value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.70|1.03|0.013
91726108|NCT03158311|183347269|SUPERIORITY||LS Mean|-0.003|STANDARD_ERROR_OF_MEAN|0.027||0.908|TWO_SIDED|95.0|-0.055|0.049||P-Value is two-sided|MMRM|||Week 8||0.049|-0.055|0.908
91528187|NCT01544491|182931644|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|5.25||0.9712|TWO_SIDED|80.0|-6.6|6.8|||Log Rank|||at 12 months||6.8|-6.6|0.9712
91528188|NCT01544491|182931644|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|5.84||0.9634|TWO_SIDED|80.0|-7.3|7.7|||Log Rank|||36 months||7.7|-7.3|0.9634
91528189|NCT01544491|182931645|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|5.26||0.3455|TWO_SIDED|80.0|-1.8|11.8|||t-test, 2 sided|||at 12 months||11.8|-1.8|0.3455
91528190|NCT01544491|182931645|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.95||0.8642|TWO_SIDED|80.0|-5.5|7.2|||t-test, 2 sided|||36 months||7.2|-5.5|0.8642
91528191|NCT01234649|182931657|SUPERIORITY||||||<|0.04|||||||ANOVA|||Factorial repeated measures design||||<0.04
91528192|NCT01234649|182931658|SUPERIORITY||||||<|0.005|||||||ANOVA|||Factorial repeated measures ANOVA||||<.005
91528193|NCT01234649|182931659|SUPERIORITY||||||<|0.011|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.011
91695356|NCT01197534|183285904|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
91528194|NCT01234649|182931660|SUPERIORITY||||||>|0.05|||||||ANOVA|||Nested repeated measures design||||>0.05
91528195|NCT01234649|182931661|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.03
91528196|NCT01234649|182931662|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528197|NCT01234649|182931663|SUPERIORITY||||||<|0.048|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.048
91528198|NCT01234649|182931664|SUPERIORITY||||||<|0.04|||||||ANOVA|||||||<0.04
91695357|NCT01197534|183285904|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
91726109|NCT03158311|183347269|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.026||0.046|TWO_SIDED|95.0|0.001|0.104||P-Value is two-sided|MMRM|||Week 8||0.104|0.001|0.046
91528199|NCT01234649|182931665|SUPERIORITY||||||<|0.047|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.047
91528200|NCT01234649|182931666|SUPERIORITY||||||<|0.023|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.023
91528201|NCT01234649|182931667|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528202|NCT01234649|182931668|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA||||0.042
91528203|NCT01234649|182931669|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528204|NCT01234649|182931670|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528205|NCT01234649|182931671|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528206|NCT01234649|182931672|SUPERIORITY||||||<|0.046|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.046
91528207|NCT01234649|182931673|SUPERIORITY||||||<|0.049|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.049
91528208|NCT01234649|182931674|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528209|NCT01234649|182931675|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528210|NCT01234649|182931676|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528211|NCT01234649|182931677|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528212|NCT01234649|182931678|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
91528213|NCT00680056|182931686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.0|STANDARD_DEVIATION|60.0||0.038||95.0|||||t-test, 2 sided||Mean difference= Formoterol plus Tiotropium minus Formoterol plus Placebo(Tiotropium)|It was calculated a total sample size of a 2x2 cross-over design as 24 for a two-sided t-test achieves 85% power to infer that the mean difference is not zero, the actual mean difference is 20, the standard deviation of the differences is 15, and the significance level is 0.05||||0.038
91528214|NCT00680056|182931687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_DEVIATION|2.39||0.054||95.0|||||t-test, 2 sided||Mean difference=Arm 2 minus Arm 1|||||0.054
91528215|NCT03688711|182931688|SUPERIORITY||||||<|0.0001|||||||Log Rank|||The recovery rates of dasiglucagon and placebo were evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests stratified by injection site.||||<0.0001
91528216|NCT03688711|182931689|SUPERIORITY|||||||0.0012|||||||Fisher Exact|||Assessed at 30 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0012
91726110|NCT03158311|183347269|SUPERIORITY||LS Mean|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.87|TWO_SIDED|95.0|-0.047|0.056||P-Value is two-sided|MMRM|||Week 16||0.056|-0.047|0.870
91726111|NCT03158311|183347269|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.026||0.028|TWO_SIDED|95.0|0.006|0.109||P-Value is two-sided|MMRM|||Week 16||0.109|0.006|0.028
91726112|NCT03158311|183347269|SUPERIORITY||LS Mean|0.028|STANDARD_ERROR_OF_MEAN|0.028||0.303|TWO_SIDED|95.0|-0.026|0.083||P-Value is two-sided|MMRM|||Week 24||0.083|-0.026|0.303
91726113|NCT03158311|183347269|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.027|<|0.001|TWO_SIDED|95.0|0.041|0.148||P-Value is two-sided|MMRM|||Week 24||0.148|0.041|<0.001
91726114|NCT03158311|183347270|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.563|TWO_SIDED|95.0|-0.048|0.087||P-value is two-sided|MMRM|||Week 8||0.087|-0.048|0.563
91726115|NCT03158311|183347270|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.034||0.068|TWO_SIDED|95.0|-0.005|0.129||P-Value is two-sided|MMRM|||Week 8||0.129|-0.005|0.068
91726116|NCT03158311|183347270|SUPERIORITY||LS Mean|-0.007|STANDARD_ERROR_OF_MEAN|0.035||0.844|TWO_SIDED|95.0|-0.076|0.062||P-Value is two-sided|MMRM|||Week 16||0.062|-0.076|0.844
91726117|NCT03158311|183347270|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.035||0.097|TWO_SIDED|95.0|-0.01|0.125||P-Value is two-sided|MMRM|||Week 16||0.125|-0.010|0.097
91726118|NCT03158311|183347270|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.036||0.927|TWO_SIDED|95.0|-0.067|0.074||P-Value is two-sided|MMRM|||Week 24||0.074|-0.067|0.927
91726119|NCT03158311|183347270|SUPERIORITY||LS Mean|0.089|STANDARD_ERROR_OF_MEAN|0.036||0.013|TWO_SIDED|95.0|0.019|0.159||P-Value is two-sided|MMRM|||Week 24||0.159|0.019|0.013
91726120|NCT00724503|183347278|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.551|TWO_SIDED|95.0|0.77|1.12|||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.||1.12|0.77|0.551
91726121|NCT00724503|183347279|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||< 0.05
91726122|NCT01186419|183347283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0765|TWO_SIDED||||||t-test, 2 sided|||||||0.0765
91726123|NCT01033071|183347290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||<|0.001||95.0|-7.6|-3.1||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.||-3.1|-7.6|<0.001
91726124|NCT01033071|183347290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.2|-4.6||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.6|-9.2|<0.001
91490255|NCT01663532|182852913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.0023|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.3|-1.6|0.0023
91726125|NCT01033071|183347293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED|95.0|-9.4|-4.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.7|-9.4|<0.001
91726126|NCT01033071|183347293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-11.5|-6.6||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.6|-11.5|<0.001
91726127|NCT01033071|183347295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-8.5|-4.3||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.3|-8.5|<0.001
91726128|NCT01033071|183347295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.0|-6.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.7|-11.0|<0.001
91726129|NCT00727064|183347308|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
91726130|NCT00727064|183347309|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
91726131|NCT00727064|183347310|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.004
91726132|NCT00727064|183347311|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.018
91726133|NCT00727064|183347312|SUPERIORITY_OR_OTHER|||||||0.081|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.081
91726134|NCT00727064|183347313|SUPERIORITY_OR_OTHER|||||||0.427|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.427
91758704|NCT00235716|183410637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.84|TWO_SIDED|95.0|-1.88|1.06||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.06|-1.88|0.84
91726135|NCT00666978|183347323|SUPERIORITY|The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.|Odds Ratio (OR)|1.39||||0.23|TWO_SIDED|95.0|0.82|2.35||All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.|t-test, 2 sided||Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .|Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.||2.35|0.82|.23
91726136|NCT00666978|183347324|OTHER||Odds Ratio (OR)|0.97||||0.0022|TWO_SIDED|95.0|0.95|0.99||This reflects Week 7.|Regression, Logistic||This reflects Week 7.|||0.99|0.95|0.0022
91726137|NCT00666978|183347325|OTHER||Odds Ratio (OR)|2.82|||<|0.05|TWO_SIDED|||||Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.|Regression, Linear||Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.|||||<0.05
91726138|NCT00299221|183347336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.44||95.0|||||t-test, 2 sided|||comparing ISHLT biopsy score between groups at 1 year||||0.44
91726139|NCT03676725|183347341|SUPERIORITY||Odds Ratio (OR)|5.17||||0.017|ONE_SIDED||||||Fisher Exact|||Women with PMS vs. without PMS.||||0.017
91726140|NCT03676725|183347341|SUPERIORITY||Odds Ratio (OR)|16.0||||0.001|TWO_SIDED||||||Fisher Exact|||Women with PMS and with ADHD vs. other women||||0.001
91726141|NCT03676725|183347341|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8|TWO_SIDED||||||Fisher Exact|||ADHD vs. no ADHD||||0.8
91726142|NCT01579305|183347344|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.|Difference in responder rates|4.9|||||ONE_SIDED|97.5|-6.7||||||Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.|The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.|||-6.7|
91726143|NCT02734147|183347385|OTHER|||||||0.631|||||||Other|||||||0.631
91726144|NCT02734147|183347386|OTHER|||||||0.64|||||||Other|||||||0.640
91726145|NCT02734147|183347387|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
91726146|NCT02734147|183347388|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
91726147|NCT02734147|183347389|SUPERIORITY|||||||0.133|||||||Fisher Exact|||||||0.133
91726148|NCT02734147|183347390|OTHER|||||||0.566|||||||Other|||||||0.566
91726149|NCT02734147|183347391|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91726150|NCT01835756|183347474|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED||||||t-test, 2 sided|||||||<0.00001
91726151|NCT01835756|183347475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91726152|NCT00888849|183347521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|7.69||0.7774|TWO_SIDED|95.0|-19.4|10.9||Adjusted for multiplicity via the Bonferroni-Holm method|ANOVA|||||10.9|-19.4|0.7774
91726153|NCT00888849|183347522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.8||0.0008|TWO_SIDED|95.0|1.4|4.5||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||4.5|1.4|0.0008
91726154|NCT00888849|183347523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.7774|TWO_SIDED|95.0|-0.2|0.6||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||0.6|-0.2|0.7774
91726155|NCT05064800|183347524|OTHER||Ratio of Adjusted Geometric Means|233.06|||||TWO_SIDED|90.0|172.14|315.54|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||315.54|172.14|
91726156|NCT05064800|183347525|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
91760005|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||||TWO_SIDED|95.0|-0.64|18.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||18.78|-0.64|
91760006|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-10.0|9.28||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.28|-10.00|
91760007|NCT01393639|183411990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.69|||||TWO_SIDED|95.0|-2.91|16.29||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.29|-2.91|
91726157|NCT05064800|183347526|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
91726158|NCT05064800|183347527|OTHER||Ratio of Adjusted Geometric Means|171.91|||||TWO_SIDED|90.0|127.51|231.77|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||231.77|127.51|
91726159|NCT05064800|183347528|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
91726160|NCT05064800|183347529|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
91726161|NCT02508207|183347544|OTHER|||||||0.7151||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.7151
91726162|NCT02508207|183347545|OTHER|||||||0.0004||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0004
91726163|NCT02508207|183347546|OTHER|||||||0.3345|||||||t-test, 2 sided|p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.||||||0.3345
91726164|NCT02508207|183347547|OTHER|||||||0.0002||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0002
91726165|NCT00395512|183347589|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.78|-0.33||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.||-0.33|-0.78|<0.001
91726166|NCT00395512|183347589|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.53|-0.98|<0.001
91726167|NCT00395512|183347589|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.63|-0.18||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.18|-0.63|<0.001
91726168|NCT00395512|183347590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.12|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-0.12|-0.55|0.003
91528217|NCT03688711|182931689|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 20 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91726169|NCT00395512|183347590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.30|-0.74|<0.001
91726170|NCT00395512|183347590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.51|-0.94|<0.001
91726171|NCT00395512|183347591|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.017|TWO_SIDED|95.0|-20.3|-2.0|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-2.0|-20.3|0.017
91726172|NCT00395512|183347591|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9||||0.006|TWO_SIDED|95.0|-22.0|-3.8|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-3.8|-22.0|0.006
91726173|NCT00395512|183347591|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.5|||<|0.001|TWO_SIDED|95.0|-33.5|-15.4|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-15.4|-33.5|<0.001
91726174|NCT01222351|183347644|EQUIVALENCE|The null hypothesis was that there is no difference in the rate of cognitive decline between participants with and without amyloid.|Slope|-0.034||||0.02|TWO_SIDED||||||latent growth curve model|Latent growth curve models tested cognitive decline rate by amyloid status.|B weights were the estimates for the association between Aβ and cognitive change.|||||0.02
91726175|NCT02021318|183347652|NON_INFERIORITY|Non-inferiority of roxadustat versus darbepoetin alfa, margin = -15% (non-inferiority is concluded if the lower limit of the 95% confidence interval of the difference was \>-15%).|Difference in percentage|11.51|||||TWO_SIDED|95.0|5.66|17.36||||||A generalized linear model as an approximation for the Miettinen and Nurminen method, adjusted for stratification factors (actual) was used to estimate the difference of proportions and 95% confidence interval.||17.36|5.66|
91726176|NCT02021318|183347653|NON_INFERIORITY|Non-Inferiority, margin = -0.75 (non-inferiority is concluded if the lower bound of the 95% CI of the least square mean difference (LSM) is \> -0.75 g/dL).|LSM Difference|0.015||||0.839|TWO_SIDED|95.0|-0.131|0.162|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.162|-0.131|0.839
91726177|NCT02021318|183347654|SUPERIORITY||LSM Difference|-0.403|||<|0.001|TWO_SIDED|95.0|-0.51|-0.296|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline LDL, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.296|-0.510|<0.001
91726178|NCT02021318|183347655|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.004|TWO_SIDED|95.0|0.26|0.78|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.78|0.26|0.004
91726179|NCT02021318|183347656|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-1.284||||0.027|TWO_SIDED|95.0|-2.423|-0.145|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28) visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PF, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.145|-2.423|0.027
91726180|NCT02021318|183347657|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-0.457||||0.454|TWO_SIDED|95.0|-1.656|0.742|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28), visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 VT, baseline Hb, baseline eGFR as continuous covariates.||0.742|-1.656|0.454
91726181|NCT02021318|183347658|NON_INFERIORITY|Non-Inferiority, margin = 1 mmHg (non-inferiority is concluded if the upper bound of the 95% confidence interval of the LSM difference is \< 1).|LSM Difference|-0.372||||0.547|TWO_SIDED|95.0|-1.587|0.842|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||0.842|-1.587|0.547
91726182|NCT02021318|183347659|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3). Non-Inferiority was declared if the upper bound of the 95% CI is below 1.3.|Hazard Ratio (HR)|0.83||||0.336|TWO_SIDED|95.0|0.56|1.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.22|0.56|0.336
91490256|NCT01663532|182852913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.0032|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-2.0|0.0032
91726183|NCT02021318|183347660|SUPERIORITY||LSM Difference|-0.136||||0.818|TWO_SIDED|95.0|-1.299|1.026|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||1.026|-1.299|0.818
91726184|NCT02021318|183347661|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.452|TWO_SIDED|95.0|0.6|1.26|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.26|0.60|0.452
91726185|NCT02021318|183347662|SUPERIORITY||LSM Difference|0.038||||0.529|TWO_SIDED|95.0|-0.081|0.157|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.157|-0.081|0.529
91726186|NCT02021318|183347663|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.001|TWO_SIDED|95.0|1.38|1.96|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.96|1.38|<0.001
91726187|NCT02021318|183347664|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|95.0|1.39|1.98|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.98|1.39|<0.001
91726188|NCT02021318|183347665|SUPERIORITY||LSM Difference|0.051||||0.478|TWO_SIDED|95.0|-0.091|0.194|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.194|-0.091|0.478
91726189|NCT02021318|183347665|SUPERIORITY||LSM Difference|-0.003||||0.969|TWO_SIDED|95.0|-0.149|0.143|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.143|-0.149|0.969
91695358|NCT01197534|183285905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|3.42|14.8|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.80|3.42|<0.001
91490257|NCT01663532|182852913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.7|-0.8|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.8|-2.7|0.0003
91695359|NCT01197534|183285905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|1.88|8.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.65|1.88|<0.001
91695360|NCT01197534|183285906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.3|||<|0.001|TWO_SIDED|95.0|3.23|16.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||16.65|3.23|<0.001
91695361|NCT01197534|183285906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.81|14.71|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.71|2.81|<0.001
91695362|NCT01197534|183285907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|2.06|3.91||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.91|2.06|<0.001
91695363|NCT01197534|183285907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.77|3.37||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.37|1.77|<0.001
91695364|NCT01197534|183285908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.73|3.46|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.46|1.73|<0.001
91695365|NCT01197534|183285908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.46|2.94|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.94|1.46|<0.001
91695366|NCT01197534|183285909|SUPERIORITY_OR_OTHER|||||||0.904||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.904
91726190|NCT02021318|183347665|SUPERIORITY||LSM Difference|0.009||||0.91|TWO_SIDED|95.0|-0.14|0.157|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.140|0.910
91726191|NCT02021318|183347665|SUPERIORITY||LSM Difference|0.024||||0.775|TWO_SIDED|95.0|-0.14|0.188|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.188|-0.140|0.775
91726192|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.087||||0.086|TWO_SIDED|95.0|-0.012|0.185|||Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.012|0.086
91726193|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.278|||<|0.001|TWO_SIDED|95.0|0.165|0.391|||Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.391|0.165|<0.001
91726194|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.435|||<|0.001|TWO_SIDED|95.0|0.284|0.586|||Mixed Models Analysis|||Week 4- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.586|0.284|<0.001
91726195|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.422|||<|0.001|TWO_SIDED|95.0|0.254|0.59|||Mixed Models Analysis|||Week 6- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.590|0.254|<0.001
91490258|NCT01663532|182852913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.2|<.0001
91490259|NCT01663532|182852913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.4|-3.7|<.0001
91490260|NCT01663532|182852913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.6|-4.1|<.0001
91726196|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.38|||<|0.001|TWO_SIDED|95.0|0.205|0.556|||Mixed Models Analysis|||Week 8- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.556|0.205|<0.001
91726197|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.155|0.505|||Mixed Models Analysis|||Week 10- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.505|0.155|<0.001
91726198|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.3||||0.001|TWO_SIDED|95.0|0.119|0.482|||Mixed Models Analysis|||Week 12- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.482|0.119|0.001
91726199|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.159||||0.079|TWO_SIDED|95.0|-0.018|0.336|||Mixed Models Analysis|||Week 14- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|-0.018|0.079
91726200|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.183||||0.044|TWO_SIDED|95.0|0.005|0.361|||Mixed Models Analysis|||Week 16- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.361|0.005|0.044
91726201|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.173||||0.037|TWO_SIDED|95.0|0.01|0.336|||Mixed Models Analysis|||Week 18- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|0.010|0.037
91726202|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.085||||0.319|TWO_SIDED|95.0|-0.083|0.253|||Mixed Models Analysis|||Week 20- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.253|-0.083|0.319
91726203|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.03||||0.709|TWO_SIDED|95.0|-0.19|0.129|||Mixed Models Analysis|||Week 22- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.129|-0.190|0.709
91726204|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.061||||0.45|TWO_SIDED|95.0|-0.219|0.097|||Mixed Models Analysis|||Week 24- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.097|-0.219|0.450
91726205|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.065||||0.44|TWO_SIDED|95.0|-0.231|0.101|||Mixed Models Analysis|||Week 28- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.101|-0.231|0.440
91726206|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.014||||0.874|TWO_SIDED|95.0|-0.157|0.184|||Mixed Models Analysis|||Week 32- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.157|0.874
91726207|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.131||||0.132|TWO_SIDED|95.0|-0.039|0.302|||Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.302|-0.039|0.132
91726208|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.187||||0.024|TWO_SIDED|95.0|0.024|0.351|||Mixed Models Analysis|||Week 40- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.351|0.024|0.024
91726209|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.022||||0.807|TWO_SIDED|95.0|-0.153|0.197|||Mixed Models Analysis|||Week 44- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.197|-0.153|0.807
91726210|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.012||||0.89|TWO_SIDED|95.0|-0.16|0.185|||Mixed Models Analysis|||Week 48- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.160|0.890
91726211|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.029||||0.746|TWO_SIDED|95.0|-0.201|0.144|||Mixed Models Analysis|||Week 52- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.144|-0.201|0.746
91726212|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.032||||0.715|TWO_SIDED|95.0|-0.202|0.139|||Mixed Models Analysis|||Week 56- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.139|-0.202|0.715
91726213|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.066||||0.463|TWO_SIDED|95.0|-0.11|0.242|||Mixed Models Analysis|||Week 60- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.110|0.463
91726214|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.002||||0.987|TWO_SIDED|95.0|-0.187|0.184|||Mixed Models Analysis|||Week 64- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.187|0.987
91726215|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.104||||0.251|TWO_SIDED|95.0|-0.074|0.281|||Mixed Models Analysis|||Week 68- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.281|-0.074|0.251
91726216|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.067||||0.473|TWO_SIDED|95.0|-0.117|0.251|||Mixed Models Analysis|||Week 72- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.117|0.473
91726217|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.022||||0.813|TWO_SIDED|95.0|-0.204|0.16|||Mixed Models Analysis|||Week 76- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.160|-0.204|0.813
91726218|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.045||||0.622|TWO_SIDED|95.0|-0.223|0.134|||Mixed Models Analysis|||Week 80- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.134|-0.223|0.622
91695367|NCT01197534|183285909|SUPERIORITY_OR_OTHER|||||||0.342||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.342
91695368|NCT01197534|183285910|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.001|TWO_SIDED|95.0|1.47|3.48||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.48|1.47|<0.001
91490261|NCT01663532|182852914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.0001|TWO_SIDED|95.0|4.1|10.1|||ANCOVA|ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.|Difference in least square mean of change were derived from ANCOVA model.|Statistical analysis for Week 10.||10.1|4.1|<.0001
91528218|NCT03688711|182931689|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 15 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91528219|NCT03688711|182931689|SUPERIORITY|||||||0.0006|||||||Fisher Exact|||Assessed at 10 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0006
91726219|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.045||||0.632|TWO_SIDED|95.0|-0.138|0.227|||Mixed Models Analysis|||Week 84- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.227|-0.138|0.632
91726220|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.055||||0.568|TWO_SIDED|95.0|-0.133|0.242|||Mixed Models Analysis|||Week 88- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.133|0.568
91726221|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.034||||0.729|TWO_SIDED|95.0|-0.158|0.226|||Mixed Models Analysis|||Week 92- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.226|-0.158|0.729
91726222|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.025||||0.797|TWO_SIDED|95.0|-0.168|0.218|||Mixed Models Analysis|||Week 96- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.218|-0.168|0.797
91726223|NCT02021318|183347666|SUPERIORITY||LSM Difference|-0.11||||0.28|TWO_SIDED|95.0|-0.31|0.09|||Mixed Models Analysis|||Week 100- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.090|-0.310|0.280
91726224|NCT02021318|183347666|SUPERIORITY||LSM Difference|0.037||||0.733|TWO_SIDED|95.0|-0.177|0.251|||Mixed Models Analysis|||Week 104- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.177|0.733
91726225|NCT02021318|183347667|SUPERIORITY||LSM Difference|0.026||||0.727|TWO_SIDED|95.0|-0.119|0.17|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.170|-0.119|0.727
91726226|NCT02021318|183347667|SUPERIORITY||LSM Difference|-0.001||||0.985|TWO_SIDED|95.0|-0.151|0.148|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.148|-0.151|0.985
91528220|NCT03688711|182931690|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 30 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91528221|NCT03688711|182931690|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 20 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91726227|NCT02021318|183347667|SUPERIORITY||LSM Difference|0.003||||0.965|TWO_SIDED|95.0|-0.148|0.154|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.154|-0.148|0.965
91726228|NCT02021318|183347667|SUPERIORITY||LSM Difference|-0.016||||0.856|TWO_SIDED|95.0|-0.188|0.157|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.188|0.856
91726229|NCT02021318|183347669|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.22|1.36|<0.001
91726230|NCT02021318|183347672|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.079|TWO_SIDED|95.0|0.98|1.5|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.50|0.98|0.079
91726231|NCT02021318|183347673|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.3|TWO_SIDED|95.0|0.79|2.11|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.11|0.79|0.300
91726232|NCT02021318|183347677|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.055|TWO_SIDED|95.0|0.99|2.54|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.54|0.99|0.055
91726233|NCT02021318|183347680|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.052|TWO_SIDED|95.0|0.51|1.0|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.00|0.51|0.052
91726234|NCT02021318|183347690|SUPERIORITY||LSM Difference|-1.068||||0.027|TWO_SIDED|95.0|-2.012|-0.124|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.124|-2.012|0.027
91695369|NCT01197534|183285910|SUPERIORITY_OR_OTHER||Treatment difference|1.64||||0.001|TWO_SIDED|95.0|0.63|2.65||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.65|0.63|0.001
91528222|NCT03688711|182931690|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 15 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91695370|NCT01197534|183285911|SUPERIORITY_OR_OTHER||Treatment difference|2.09|||<|0.001|TWO_SIDED|95.0|0.97|3.2||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.20|0.97|<0.001
91695371|NCT01197534|183285911|SUPERIORITY_OR_OTHER||Treatment difference|1.96|||<|0.001|TWO_SIDED|95.0|0.83|3.08||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.08|0.83|<0.001
91695372|NCT02593097|183285919|SUPERIORITY|||||||0.83|||||||Hills-Armitage|||||||0.83
91695373|NCT02593097|183285920|SUPERIORITY|||||||0.16|||||||McNemar|||||||0.16
91695374|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||A priori threshold p \< 0.05|Repeated Measures ANOVA|||||||<0.00005
91695375|NCT02811965|183285939|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
91695376|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695377|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695378|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695379|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91726235|NCT02021318|183347690|SUPERIORITY||LSM Difference|-0.603||||0.239|TWO_SIDED|95.0|-1.606|0.401|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.401|-1.606|0.239
91726236|NCT02021318|183347691|SUPERIORITY||LSM Difference|-0.528||||0.517|TWO_SIDED|95.0|-2.127|1.072|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.072|-2.127|0.517
91726237|NCT02021318|183347691|SUPERIORITY||LSM Difference|-0.947||||0.308|TWO_SIDED|95.0|-2.771|0.877|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.877|-2.771|0.308
91726238|NCT02021318|183347692|SUPERIORITY||LSM Difference|-0.904||||0.57|TWO_SIDED|95.0|-4.032|2.224|||Mixed Models Analysis|||Week 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||2.224|-4.032|0.570
91695380|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695381|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695382|NCT02811965|183285939|SUPERIORITY|||||||0.01||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.01
91695383|NCT02811965|183285939|SUPERIORITY|||||||0.0002||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0002
91695384|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695385|NCT02811965|183285939|SUPERIORITY||||||<|5e-05|||||||t-test, 2 sided|||||||<0.00005
91695386|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695387|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695388|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695389|NCT02811965|183285939|SUPERIORITY|||||||0.24||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.24
91726239|NCT02021318|183347692|SUPERIORITY||LSM Difference|-1.767||||0.334|TWO_SIDED|95.0|-5.354|1.82|||Mixed Models Analysis|||Weeks 36-52 -The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.820|-5.354|0.334
91726240|NCT02021318|183347694|SUPERIORITY||LSM Difference|0.784||||0.497|TWO_SIDED|95.0|-1.481|3.049|||Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline EQ-5D 5L VAS, baseline Hb, baseline eGFR as continuous covariates.||3.049|-1.481|0.497
91726241|NCT02021318|183347705|SUPERIORITY||LSM Difference|-0.05||||0.902|TWO_SIDED|95.0|-0.93|0.82|||Mixed Models Analysis|||||0.82|-0.93|0.902
91726242|NCT02021318|183347707|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.79|1.29|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.29|0.79|0.960
91726243|NCT02021318|183347709|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.939|TWO_SIDED|95.0|0.79|1.25|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.25|0.79|0.939
91726244|NCT02021318|183347710|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.948|TWO_SIDED|95.0|0.77|1.27|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.27|0.77|0.948
91695390|NCT02811965|183285939|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
91695391|NCT02811965|183285939|SUPERIORITY|||||||0.0093||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0093
91695392|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695393|NCT02811965|183285939|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
91695394|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695395|NCT02811965|183285939|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91726245|NCT02021318|183347711|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.568|TWO_SIDED|95.0|0.75|1.17|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.17|0.75|0.568
91726246|NCT01740427|183347718|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|1e-06|TWO_SIDED|95.0|0.463|0.718||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||0.718|0.463|<0.000001
91726247|NCT01740427|183347719|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.428||||0.0224|TWO_SIDED|95.0|1.008|2.03||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.030|1.008|0.0224
91726248|NCT01740427|183347720|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.594||||0.009|TWO_SIDED|95.0|1.08|2.347||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.347|1.080|0.0090
91726249|NCT01740427|183347722|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.451|||<|0.0001|TWO_SIDED|95.0|1.619|3.722||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.||3.722|1.619|<0.0001
91695396|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||A priori threshold p\<0.05.|Repeated Measures ANOVA|||||||<0.00005
91695397|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695398|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91726250|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.571|||<|0.0001|TWO_SIDED|95.0|0.443|0.737|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER positive||0.737|0.443|<0.0001
91726251|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.405||||0.003|TWO_SIDED|95.0|0.218|0.751|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER Negative||0.751|0.218|0.0030
91695399|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695400|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695401|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695402|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695403|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695404|NCT02811965|183285940|SUPERIORITY|||||||0.0011||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0011
91695405|NCT02811965|183285940|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
91695406|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695407|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695408|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695409|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695410|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695411|NCT02811965|183285940|SUPERIORITY|||||||0.53||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.53
91695412|NCT02811965|183285940|SUPERIORITY|||||||0.092||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.092
91695413|NCT02811965|183285940|SUPERIORITY|||||||0.0044|||||||t-test, 2 sided|||||||0.0044
91695414|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695415|NCT02811965|183285940|SUPERIORITY|||||||0.084||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.084
91695416|NCT02811965|183285940|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
91695417|NCT02811965|183285940|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
91695418|NCT01554527|183285941|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.07
91695419|NCT01554527|183285942|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.34
91695420|NCT01554527|183285943|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.93
91695421|NCT01554527|183285944|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.5
91695422|NCT01554527|183285945|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.25
91695423|NCT03627546|183285970|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
91695424|NCT03627546|183285971|SUPERIORITY|||||||0.0007|||||||Chi-squared|||||||0.0007
91695425|NCT01537042|183285981|SUPERIORITY_OR_OTHER||Treatment Ratio|0.44||||0.0232|TWO_SIDED|95.0|0.22|0.88|||ANCOVA|An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.||||0.88|0.22|0.0232
91695426|NCT02837731|183285996|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.021|TWO_SIDED|95.0|-2.53|0.21|||t-test, 2 sided|||||0.21|-2.53|0.021
91695427|NCT02837731|183285997|OTHER||Mean Difference (Final Values)|-0.124||||0.042|TWO_SIDED|95.0|-0.27|-0.01|||Fisher Exact||Converted Estimated Value of -12.4% to decimal value of -0.124.|||-0.01|-0.27|0.042
91695428|NCT02837731|183285998|OTHER||Mean Difference (Final Values)|-0.1642||||0.044|TWO_SIDED|95.0|-0.33|0.0|||Chi-squared||Converted Estimated Value of -16.42% to decimal value of -0.1642.|||0|-0.33|0.044
91695429|NCT02837731|183285999|OTHER||Mean Difference (Final Values)|-2.91||||0.113|TWO_SIDED|95.0|-6.67|0.85|||Fisher Exact|||||0.85|-6.67|0.113
91695430|NCT02837731|183286000|OTHER||Mean Difference (Final Values)|-72.43|||||TWO_SIDED|95.0|-154.08|9.22|||Wilcoxon (Mann-Whitney)|||||9.22|-154.08|
91695431|NCT02837731|183286001|OTHER||Mean Difference (Final Values)|-14.91||||0.426|TWO_SIDED|95.0|-52.5|22.68|||Wilcoxon (Mann-Whitney)|||||22.68|-52.50|0.426
91695432|NCT02837731|183286002|OTHER||Mean Difference (Final Values)|0.09||||0.453|TWO_SIDED|95.0|-0.34|0.52|||ANCOVA|||||0.52|-0.34|0.453
91695433|NCT01329380|183286035|OTHER|||||||0.0328|||||||Mann-Whitney U-test|||Age||||0.0328
91695434|NCT01329380|183286035|OTHER|||||||0.7128|||||||Fisher Exact|||Sex||||0.7128
91695435|NCT01329380|183286035|OTHER|||||||0.0465|||||||Mann-Whitney U-test|||Body mass index||||0.0465
91695436|NCT01329380|183286035|OTHER|||||||0.8872|||||||Mann-Whitney U-test|||Duration of illness||||0.8872
91695437|NCT01329380|183286035|OTHER|||||||0.0388|||||||Fisher Exact|||Smoking history||||0.0388
91695438|NCT01329380|183286035|OTHER|||||||0.4855|||||||Fisher Exact|||Complications||||0.4855
91695439|NCT01329380|183286035|OTHER|||||||0.663|||||||Fisher Exact|||Complications - Liver disorder||||0.6630
91695440|NCT01329380|183286035|OTHER|||||||0.2067|||||||Fisher Exact|||Complications - Renal disorder||||0.2067
91695441|NCT01329380|183286035|OTHER|||||||0.8749|||||||Fisher Exact|||Complications - Cardiovascular disorder||||0.8749
91695442|NCT01329380|183286035|OTHER|||||||0.482|||||||Fisher Exact|||Complications - Blood disorder||||0.4820
91726252|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.531|||<|0.0001|TWO_SIDED|95.0|0.416|0.68|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Positive||0.680|0.416|<0.0001
91726253|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.675||||0.3237|TWO_SIDED|95.0|0.308|1.481|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Negative||1.481|0.308|0.3237
91726254|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.555|||<|0.0001|TWO_SIDED|95.0|0.437|0.705|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Positive||0.705|0.437|<0.0001
91726255|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.9964|TWO_SIDED|95.0|0.287|3.461|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Negative||3.461|0.287|0.9964
91726256|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.518|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Positive||0.670|0.400|<0.0001
91726257|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731||||0.3221|TWO_SIDED|95.0|0.392|1.364|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Negative||1.364|0.392|0.3221
91490262|NCT01663532|182852915|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||||<.0001
91695443|NCT01329380|183286035|OTHER|||||||0.6355|||||||Fisher Exact|||Complications - Respiratory disorder||||0.6355
91695444|NCT01329380|183286035|OTHER|||||||0.8193|||||||Fisher Exact|||Complications - Diabetes mellitus||||0.8193
91695445|NCT01329380|183286035|OTHER|||||||0.5723|||||||Fisher Exact|||Complications - Uveitis||||0.5723
91695446|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||Complications - Inflammatory bowel disease||||1.0000
91695447|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||Complications - Psoriasis||||1.0000
91695448|NCT01329380|183286035|OTHER|||||||0.0144|||||||Fisher Exact|||Past Illnesses||||0.0144
91695449|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||Allergy history||||1.0000
91695450|NCT01329380|183286035|OTHER|||||||0.3928|||||||Fisher Exact|||Adalimumab self-injection status||||0.3928
91695451|NCT01329380|183286035|OTHER|||||||0.2735|||||||Fisher Exact|||Prior medications - NSAIDs||||0.2735
91695452|NCT01329380|183286035|OTHER|||||||0.8875|||||||Fisher Exact|||Prior medications - Biological products||||0.8875
91695453|NCT01329380|183286035|OTHER|||||||0.254|||||||Fisher Exact|||Prior medications - Adrenal corticosteroids||||0.2540
91695454|NCT01329380|183286035|OTHER|||||||0.0226|||||||Fisher Exact|||Concomitant drugs||||0.0226
91695455|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||Concomitant drug: NSAIDs||||1.0000
91695456|NCT01329380|183286035|OTHER|||||||0.2481|||||||Fisher Exact|||Concomitant drugs - DMARDs||||0.2481
91695457|NCT01329380|183286035|OTHER|||||||0.1558|||||||Fisher Exact|||Concomitant drugs - Methotrexate||||0.1558
91695458|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||Concomitant drugs - salazosulfapyridine||||1.0000
91695459|NCT01329380|183286035|OTHER|||||||0.0094|||||||Fisher Exact|||Concomitant drugs - Adrenal corticosteroids||||0.0094
91695460|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||Concomitant therapy||||1.0000
91695461|NCT01329380|183286035|OTHER|||||||0.8836|||||||Fisher Exact|||Human leukocyte antigen B27 (HLA-B27) test result||||0.8836
91695462|NCT01329380|183286035|OTHER|||||||1|||||||Fisher Exact|||BASDAI at start of treatment||||1.0000
91695463|NCT06868654|183286043|OTHER||Hazard Ratio (HR)|0.24|||||TWO_SIDED|95.0|0.11|0.56|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.56|0.11|
91695464|NCT01270464|183286098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.0507||0.0018|TWO_SIDED|95.0|0.06|0.259||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.259|0.060|0.0018
91726258|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.581|||<|0.0001|TWO_SIDED|95.0|0.455|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\<175||0.742|0.455|<0.0001
91726259|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.255||||0.0022|TWO_SIDED|95.0|0.1|0.65|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\>=175||0.650|0.100|0.0022
91726260|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.379|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \<=20%||0.742|0.379|0.0002
91726261|NCT01740427|183347723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.569||||0.0007|TWO_SIDED|95.0|0.409|0.791|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \>20%||0.791|0.409|0.0007
91726262|NCT01740427|183347727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023||||0.0925|TWO_SIDED|95.0|-0.004|0.051|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||0.051|-0.004|0.0925
91726263|NCT01740427|183347728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.325||||0.7822|TWO_SIDED|95.0|-2.63|1.98|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||1.98|-2.63|0.7822
91695465|NCT01270464|183286098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.0508||0.0237|TWO_SIDED|95.0|0.016|0.215||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.215|0.016|0.0237
91726264|NCT01740427|183347730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.956||||0.33775|TWO_SIDED|95.0|0.777|1.177||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.177|0.777|0.337750
91490263|NCT01663532|182852916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|12.9|32.4|||Cochran-Mantel-Haenszel|CMH test controlling by region (pooled sites).||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||32.4|12.9|<.0001
91490264|NCT02785432|182852917|SUPERIORITY|||||||0.55||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.55
91695466|NCT01270464|183286099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.0543||0.0174|TWO_SIDED|95.0|0.023|0.237||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.237|0.023|0.0174
91695467|NCT01270464|183286099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.0543||0.3731|TWO_SIDED|95.0|-0.058|0.155||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.155|-0.058|0.3731
91695468|NCT01270464|183286100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.1212||0.0552|TWO_SIDED|95.0|-0.005|0.472||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.472|-0.005|0.0552
91695469|NCT01270464|183286100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1215||0.802|TWO_SIDED|95.0|-0.209|0.27||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.270|-0.209|0.8020
91695470|NCT01270464|183286102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|STANDARD_ERROR_OF_MEAN|0.111||0.0014|TWO_SIDED|95.0|-0.577|-0.14||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.140|-0.577|0.0014
91695471|NCT01270464|183286102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.238|STANDARD_ERROR_OF_MEAN|0.1108||0.0329|TWO_SIDED|95.0|-0.456|-0.019||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.019|-0.456|0.0329
91695472|NCT01270464|183286103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.359|STANDARD_ERROR_OF_MEAN|0.1582||0.0241|TWO_SIDED|95.0|0.047|0.67||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.670|0.047|0.0241
91695473|NCT01270464|183286103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.1591||0.0822|TWO_SIDED|95.0|-0.036|0.591||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.591|-0.036|0.0822
91726265|NCT01740427|183347731|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.921||||0.208706|TWO_SIDED|95.0|0.755|1.124||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.124|0.755|0.208706
91726266|NCT00963508|183347734|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91726267|NCT00963508|183347735|SUPERIORITY_OR_OTHER|||||||0.0005|||||||t-test, 2 sided|||||||0.0005
91490265|NCT02785432|182852918|SUPERIORITY|||||||0.66||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.66
91695474|NCT01270464|183286104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.0193||0.016|TWO_SIDED|95.0|0.009|0.085||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.085|0.009|0.0160
91726268|NCT00165698|183347736|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Symbols rank sum test|||||||0.26
91726269|NCT00165698|183347737|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Symbols rank sum test|||||||0.19
91695475|NCT01270464|183286104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.0193||0.0094|TWO_SIDED|95.0|0.012|0.089||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.089|0.012|0.0094
91695476|NCT01270464|183286105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|0.2551||0.0151|TWO_SIDED|95.0|-1.126|-0.121||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.121|-1.126|0.0151
91695477|NCT01270464|183286105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.2559||0.0119|TWO_SIDED|95.0|-1.152|-0.144||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.144|-1.152|0.0119
91695478|NCT01270464|183286106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.494|STANDARD_ERROR_OF_MEAN|0.0242||0|TWO_SIDED|95.0|-0.542|-0.447||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Regression, Logistic|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.447|-0.542|0.0000
91695479|NCT01270464|183286106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.323|STANDARD_ERROR_OF_MEAN|0.0243||0|TWO_SIDED|95.0|-0.37|-0.275||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.275|-0.370|0.0000
91726270|NCT00165698|183347738|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Symbols rank sum test|||||||0.31
91726271|NCT00165698|183347739|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||symbols rank sum test|||||||0.869
91726272|NCT00165698|183347740|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||symbols rank sum test|||||||0.174
91726273|NCT00165698|183347741|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
91726274|NCT00165698|183347742|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
91726275|NCT00165698|183347743|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
91726276|NCT02641353|183347747|OTHER||Geometric Mean Ratio|84.9|||||TWO_SIDED|90.0|77.3|93.2|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an analysis of variance (ANOVA) model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||93.2|77.3|
91726277|NCT02641353|183347747|OTHER||Geometric Mean Ratio|78.2|||||TWO_SIDED|90.0|71.2|86.0|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||86.0|71.2|
91695480|NCT00863343|183286139|SUPERIORITY_OR_OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.59|0.94|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.94|0.59|
91695481|NCT00863343|183286139|SUPERIORITY_OR_OTHER||Specificity|0.987|||||TWO_SIDED|95.0|0.97|0.99|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.99|0.97|
91695482|NCT00863343|183286140|SUPERIORITY_OR_OTHER||Sensitivity|0.81|||||TWO_SIDED|95.0|0.63|0.92|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.92|0.63|
91695483|NCT00863343|183286140|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
91695484|NCT00863343|183286141|SUPERIORITY_OR_OTHER||Sensitivity|0.88|||||TWO_SIDED|95.0|0.7|0.96|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.96|0.70|
91695485|NCT00863343|183286141|SUPERIORITY_OR_OTHER||Specificity|0.997||||||95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
91695486|NCT00863343|183286142|SUPERIORITY_OR_OTHER||Sensitivity|0.79|||||TWO_SIDED|95.0|0.6|0.9|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.90|0.60|
91695487|NCT00863343|183286142|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
91695488|NCT01322490|183286143|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.4742||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.4742
91695489|NCT01322490|183286143|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.5885||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.5885
91695490|NCT01322490|183286144|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.9588|||||TWO_SIDED|95.0|0.7144|1.2867|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2867|0.7144|
91695491|NCT01322490|183286144|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.8941|||||TWO_SIDED|95.0|0.6647|1.2026|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2026|0.6647|
91695492|NCT02484456|183286145|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.79||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
91695493|NCT02484456|183286146|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.72||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
91695494|NCT02484456|183286147|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.89||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
91695495|NCT02484456|183286148|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.06||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
91695496|NCT02484456|183286149|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.27||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
91695497|NCT02484456|183286150|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.58||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
91695498|NCT02484456|183286151|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.02||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
91490266|NCT02785432|182852919|SUPERIORITY|||||||0.51||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.51
91490267|NCT02785432|182852920|SUPERIORITY|||||||0.96||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.96
91490268|NCT00283400|182852969|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05|||<|0.05|TWO_SIDED|95.0|0.65|14.1|||Mixed Models Analysis|Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.||||14.1|0.65|<0.05
91695499|NCT02484456|183286152|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.34||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
91695500|NCT02484456|183286153|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
91695501|NCT02484456|183286154|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
91695502|NCT02484456|183286155|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.76||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
91695503|NCT02484456|183286156|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|1.89||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
91695504|NCT02484456|183286157|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.92||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
91695505|NCT02484456|183286158|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.98||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
91695506|NCT02484456|183286159|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.1||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
91695507|NCT02484456|183286160|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.91||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91695508|NCT02484456|183286161|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|1.3||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
91695509|NCT02484456|183286162|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|1.26||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
91695510|NCT02484456|183286163|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.98||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
91695511|NCT02484456|183286164|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.23||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
91726278|NCT02641353|183347748|OTHER||Geometric Mean Ratio|87.6|||||TWO_SIDED|90.0|83.0|92.5|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||92.5|83.0|
91695512|NCT02484456|183286165|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|1.39||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
91695513|NCT02484456|183286166|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.31||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
91695514|NCT02484456|183286167|SUPERIORITY||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|1.89||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.35
91695515|NCT02484456|183286168|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.63||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
91726279|NCT02641353|183347748|OTHER||Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|109.2|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||121.7|109.2|
91695516|NCT01908829|183286186|SUPERIORITY||Least Squares (LS) Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.47|-0.05||P values for pairwise comparisons were from the stratified rank ANCOVA model. P \< 0.05 indicated superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.05|-0.47|=0.001
91695517|NCT01908829|183286187|SUPERIORITY||LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.14|-0.52|<0.001
91695518|NCT01908829|183286187|SUPERIORITY||LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.18||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.18|-0.60|<0.001
91695519|NCT01908829|183286187|SUPERIORITY||LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.46|-0.03||P-values for pairwise comparisons are from the stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.03|-0.46|=0.001
91695520|NCT01908829|183286188|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.01|TWO_SIDED|95.0|-0.47|-0.06||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.06|-0.47|=0.010
91695521|NCT01908829|183286188|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.19||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.65|<0.001
91726280|NCT02641353|183347749|OTHER||Geometric Mean Ratio|87.8|||||TWO_SIDED|90.0|83.2|92.6|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||92.6|83.2|
91726281|NCT02641353|183347749|OTHER||Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|109.0|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||121.7|109.0|
91726282|NCT02641353|183347750|OTHER||Median Difference|0.25||||0.1508|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon signed-rank test||Median difference (Treatment B - Treatment A) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% confidence interval (CI) of the median difference were calculated from the Hodges-Lehrmann estimate.||0.50|0.00|0.1508
91528223|NCT03688711|182931690|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91695522|NCT01908829|183286188|SUPERIORITY||LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.23||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.23|-0.70|<0.001
91726283|NCT02641353|183347750|OTHER||Median Difference|2.25|||<|0.0001|TWO_SIDED|90.0|1.27|3.25|||Wilcoxon signed-rank test||Median difference (Treatment C - Treatment B) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.25|1.27|<0.0001
91726284|NCT02547935|183347757|SUPERIORITY||Difference in adjusted mean change|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.37||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||-0.37|-0.80|<0.001
91726285|NCT02547935|183347758|SUPERIORITY||Difference in adjusted mean change|-38.0|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-48.2|-25.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-25.8|-48.2|<0.001
91726286|NCT02547935|183347758|SUPERIORITY||Difference in adjusted mean change|-21.0|STANDARD_ERROR_OF_MEAN|7.3||0.011|TWO_SIDED|95.0|-34.1|-5.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-5.2|-34.1|0.011
91726287|NCT02547935|183347759|SUPERIORITY||Difference in adjusted mean change|-0.04|STANDARD_ERROR_OF_MEAN|0.66||0.953|TWO_SIDED|95.0|-1.32|1.26||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||1.26|-1.32|0.953
91726288|NCT02547935|183347759|SUPERIORITY||Difference in adjusted mean change|-0.87|STANDARD_ERROR_OF_MEAN|0.66||0.193|TWO_SIDED|95.0|-2.17|0.44||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||0.44|-2.17|0.193
91726289|NCT02547935|183347760|SUPERIORITY||Difference in adjusted mean change|-6.1|STANDARD_ERROR_OF_MEAN|5.8||0.298|TWO_SIDED|95.0|-17.5|5.4||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||5.4|-17.5|0.298
91726290|NCT02547935|183347760|SUPERIORITY||Difference in adjusted mean change|-1.9|STANDARD_ERROR_OF_MEAN|5.9||0.746|TWO_SIDED|95.0|-13.6|9.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||9.8|-13.6|0.746
91726291|NCT02547935|183347761|SUPERIORITY||Odds Ratio (OR)|2.98|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||4.8|1.8|<0.001
91726292|NCT02547935|183347761|SUPERIORITY||Odds Ratio (OR)|1.86||||0.013|TWO_SIDED|95.0|1.1|3.0||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||3.0|1.1|0.013
91726293|NCT02547935|183347762|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.6|11.2||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||11.2|2.6|<0.001
91726294|NCT02547935|183347762|SUPERIORITY||Odds Ratio (OR)|1.74||||0.167|TWO_SIDED|95.0|0.8|3.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||3.8|0.8|0.167
91726295|NCT02547935|183347763|SUPERIORITY||Difference in adjusted mean change|-4.8|STANDARD_ERROR_OF_MEAN|1.8||0.009|TWO_SIDED|95.0|-8.3|-1.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||-1.2|-8.3|0.009
91726296|NCT02547935|183347763|SUPERIORITY||Difference in adjusted mean change|-2.8|STANDARD_ERROR_OF_MEAN|1.8||0.122|TWO_SIDED|95.0|-6.4|0.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||0.8|-6.4|0.122
91726297|NCT02547935|183347764|SUPERIORITY||Difference in adjusted mean change|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.142|TWO_SIDED|95.0|-0.38|0.05||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||0.05|-0.38|0.142
91726298|NCT01398475|183347765|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.02|||||TWO_SIDED|90.0|0.951|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.951|
91726299|NCT01398475|183347765|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.02|||||TWO_SIDED|90.0|0.947|1.09|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.09|0.947|
91726300|NCT01398475|183347765|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.888|||||TWO_SIDED|90.0|0.827|0.953|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.953|0.827|
91726301|NCT01398475|183347766|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|0.979|||||TWO_SIDED|90.0|0.868|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.868|
91726302|NCT01398475|183347766|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.962|||||TWO_SIDED|90.0|0.852|1.08|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.08|0.852|
91726303|NCT01398475|183347766|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.82|||||TWO_SIDED|90.0|0.727|0.925|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.925|0.727|
91726304|NCT01398475|183347767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.719|TWO_SIDED|90.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF1 fasted minus RF fasted.|||0.500|-0.250|0.719
91726305|NCT01398475|183347767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.96|TWO_SIDED|90.0|-0.25|0.75|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fasted minus RF fasted.|||0.750|-0.250|0.960
91726306|NCT01398475|183347767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fed minus TF2 fasted.|||2.00|0|0.006
91726307|NCT03461861|183347781|SUPERIORITY||Median Difference (Final Values)|-0.083|STANDARD_DEVIATION|0.0056||0.007567|TWO_SIDED|95.0|-0.0886|-0.0774|||t-test, 2 sided|||The null hypothesis (H0) of this superiority trials asserts that there is no true difference in functional connectivity between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||-0.0774|-0.0886|0.007567
91726308|NCT03461861|183347782|SUPERIORITY||Mean Difference (Final Values)|3.12|STANDARD_DEVIATION|1.4||0.900593|TWO_SIDED|95.0|1.72|4.52|||t-test, 2 sided|||The null hypothesis (H0) of this trial asserts that there is no true difference in AVLT between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||4.52|1.72|0.900593
91726309|NCT01928771|183347783|SUPERIORITY_OR_OTHER||Rate ratio|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.71|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.71|0.42|<0.001
91726310|NCT01928771|183347783|SUPERIORITY_OR_OTHER||Rate ratio|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.64|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.64|0.37|<0.001
91726311|NCT01928771|183347784|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.047|TWO_SIDED|95.0|0.5|1.0|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.0|0.5|0.047
91726312|NCT01928771|183347784|SUPERIORITY_OR_OTHER||Rate ratio|0.83||||0.268|TWO_SIDED|95.0|0.59|1.16|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.16|0.59|0.268
91726313|NCT01928771|183347785|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.053|TWO_SIDED|95.0|0.37|1.01|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||1.01|0.37|0.053
91726314|NCT01928771|183347785|SUPERIORITY_OR_OTHER||Rate ratio|0.37|||<|0.001|TWO_SIDED|95.0|0.2|0.67|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||0.67|0.2|<0.001
91726315|NCT01928771|183347786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.78|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.78|0.37|<0.001
91726316|NCT01928771|183347786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.01|TWO_SIDED|95.0|0.43|0.9|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations from the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.90|0.43|0.01
91726317|NCT01928771|183347787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.49|0.82|||Regression, Cox|Model includes treatment, number of exacerbations in the previous year, region, use of OCS||Time to first exacerbation||0.82|0.49|<0.001
91726318|NCT01928771|183347787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.46|0.78|||Regression, Cox|Model includes treatment, number of exacerbations from the previous year, region, use of OCS||Time to first exacerbation||0.78|0.46|<0.001
91726319|NCT01928771|183347788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.022|TWO_SIDED|95.0|0.016|0.196|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.196|0.016|0.022
91726320|NCT01928771|183347788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.001|TWO_SIDED|95.0|0.068|0.249|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.249|0.068|0.001
91726321|NCT01928771|183347789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.644|TWO_SIDED|95.0|-0.134|0.083|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.083|-0.134|0.644
91726322|NCT01928771|183347789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.057|TWO_SIDED|95.0|-0.003|0.208|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.208|-0.003|0.057
91726323|NCT01928771|183347790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.442|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.12|-0.27|0.442
91726324|NCT01928771|183347790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.012|TWO_SIDED|95.0|-0.45|-0.06|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.06|-0.45|0.012
91726325|NCT01928771|183347791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.169|TWO_SIDED|95.0|-0.48|0.08|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.08|-0.48|0.169
91726326|NCT01928771|183347791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.043|TWO_SIDED|95.0|-0.57|-0.01|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.01|-0.57|0.043
91726327|NCT01928771|183347792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.1|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.10|-1.16|0.1
91726328|NCT01928771|183347792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.081|TWO_SIDED|95.0|-1.21|0.07|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.07|-1.21|0.081
91726329|NCT01928771|183347793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.32||||0.001|TWO_SIDED|95.0|9.2|37.43|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||37.43|9.20|0.001
91726330|NCT01928771|183347793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.46||||0.025|TWO_SIDED|95.0|2.08|30.83|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||30.83|2.08|0.025
91726331|NCT01928771|183347794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.75||||0.002|TWO_SIDED|95.0|7.86|35.65|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||35.65|7.86|0.002
91726332|NCT01928771|183347794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.18||||0.008|TWO_SIDED|95.0|5.09|33.28|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||33.28|5.09|0.008
91726333|NCT01928771|183347795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED|95.0|-0.05|0.04|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||0.04|-0.05|0.964
91726334|NCT01928771|183347795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.012|TWO_SIDED|95.0|-0.11|-0.01|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||-0.01|-0.11|0.012
91726335|NCT01928771|183347796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.111|TWO_SIDED|95.0|-0.34|0.04|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.04|-0.34|0.111
91726336|NCT01928771|183347796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.003|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||-0.10|-0.48|0.003
91726337|NCT01928771|183347797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.27|0.27|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.27|-0.27|0.99
91726338|NCT01928771|183347797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.107|TWO_SIDED|95.0|-0.48|0.05|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.05|-0.48|0.107
91726339|NCT01928771|183347801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.081|TWO_SIDED|95.0|-0.02|0.37|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.37|-0.02|0.081
91726340|NCT01928771|183347801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.5|0.1|0.004
91490269|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07||||0.533|TWO_SIDED|90.0|-1.82|3.95|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on analysis of covariance (ANCOVA) using statistical analysis system (SAS) mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.95|-1.82|0.5330
91695523|NCT01908829|183286188|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.22||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.67|<0.001
91695524|NCT01908829|183286189|SUPERIORITY||Rate Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.05|=|0.005|TWO_SIDED|95.0|0.79|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.79|=0.005
91726341|NCT01407367|183347827|OTHER||Hazard Ratio (HR)|0.38||||0.04|TWO_SIDED|95.0|0.16|0.94||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||0.94|0.16|.04
91726342|NCT01407367|183347828|OTHER||Hazard Ratio (HR)|1.03||||0.86|TWO_SIDED|95.0|0.53|1.99||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||1.99|0.53|0.86
91726343|NCT01271855|183347829|SUPERIORITY||Z-Score|0.93||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different pain scores. Other values would fail to reject the null hypothesis.|The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||||.35
91726344|NCT01271855|183347830|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3|TWO_SIDED|95.0|0.57|6.21|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||6.21|0.57|.30
91490270|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.9532|TWO_SIDED|90.0|-4.13|3.85|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.85|-4.13|0.9532
91490271|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.53||||0.2493|TWO_SIDED|90.0|-1.11|6.18|||ANCOVA|||Change at Day 14 12 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||6.18|-1.11|0.2493
91726345|NCT01271855|183347831|SUPERIORITY||Z-Score|2.34||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different satisfaction scores. Other values fail to reject the null hypothesis|The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at discharge||||.02
91726346|NCT00004859|183347851|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Log Rank|||||||0.99
91726347|NCT00126737|183347852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.395||||0.0129|TWO_SIDED|95.0|-11.41|-1.38|||ANCOVA|Co-variates entered into the model were BMI and WOMAC function subscale.||||-1.38|-11.41|0.0129
91726348|NCT00126737|183347852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.174||||0.0535|TWO_SIDED|95.0|-10.43|0.079|||ANCOVA|Covariates entered into the model were BMI and WOMAC function||||0.079|-10.43|0.0535
91726349|NCT00126737|183347853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.545||||0.0307|TWO_SIDED|95.0|0.432|8.659|||ANCOVA|||||8.659|0.432|0.0307
91726350|NCT00126737|183347855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.94||||0.0158|TWO_SIDED|95.0|7.655|72.215|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||72.215|7.655|0.0158
91726351|NCT00126737|183347855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.25||||0.0002|TWO_SIDED|95.0|29.97|94.54|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||94.54|29.97|0.0002
91726352|NCT00126737|183347855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.95||||0.0056|TWO_SIDED|95.0|12.54|75.36|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||75.36|12.54|0.0056
91726353|NCT00126737|183347856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.129||||0.0018|TWO_SIDED|95.0|10.767|45.492|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||45.492|10.767|0.0018
91726354|NCT00126737|183347856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.71||||0.0024|TWO_SIDED|95.0|9.675|43.746|||ANCOVA|Kellgren Lawrence scale was entered into the model||||43.746|9.675|0.0024
91726355|NCT00126737|183347856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.747||||0.0368|TWO_SIDED|95.0|1.169|36.325|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||36.325|1.169|0.0368
91726356|NCT03882801|183347857|SUPERIORITY||Least Square Geometric Means Ratio|0.92|||||TWO_SIDED|90.0|0.73|1.17|||||Back transformed least squares mean and confidence interval from linear mixed effects model performed on natural log-transformed values.|||1.17|0.73|
91726357|NCT01567085|183347860|OTHER|Exact binomial test|||||<|0.001||||||The p-value was calculated from an exact binomial test, where the null hypothesis was that the true failure rate = 40%.|Exact binomial test|Exact 95% confidence interval (3.6, 17.2)||Analysis of post-transplantation treatment failure rate||||< 0.001
91726358|NCT04193176|183347863|SUPERIORITY||Mean Difference (Net)|-11.67||||0.004|TWO_SIDED|95.0|-19.67|-3.67|||ANCOVA|||||-3.67|-19.67|0.004
91726359|NCT00324857|183347866|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||"Please note that although the outcome is measured using a Likert scale, for the analysis we dichotomized the results.~P-value not adjusted for multiple comparison. Lastly, \<0.05 is the actual computed P-value."|Regression, Logistic|||Comparisons of the baseline demographic and clinical characteristics (TKR) across the 4 intervention groups were performed using chi-square tests for categorical data and analysis of variance for continuous variables. Willingness were compared across the groups over time using mixed-effect logistic regressions for dichotomous outcomes.||||<0.05
91726360|NCT00944645|183347868|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis I: The Cmax of nicotinuric acid (NUA) following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of NUA Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.98||||||90.0|0.93|1.03||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.03|0.93|
91726361|NCT00944645|183347869|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis II: The total urinary excretion of niacin and niacin metabolites following the administration of MK0524 (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of total urinary excretion of niacin and its metabolites is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.94||||||90.0|0.89|0.98||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||0.98|0.89|
91726362|NCT00944645|183347870|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis III: The AUC0-infinity of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 AUC0-∞ is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.0||||||95.0|0.95|1.05||||||"Group B: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~Group A: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.05|0.95|
91726363|NCT00944645|183347871|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis IV: The Cmax of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.02||||||95.0|0.96|1.09||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.09|0.96|
91726364|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED|95.0|0.18|0.91||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.91|0.18|<.01
91490272|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99||||0.2801|TWO_SIDED|90.0|-7.59|1.6|||ANCOVA|||Change at Day 14 2 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||1.60|-7.59|0.2801
91490273|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.9288|TWO_SIDED|90.0|-3.77|3.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.39|-3.77|0.9288
91490274|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.6459|TWO_SIDED|90.0|-2.62|4.58|||ANCOVA|||Change at Day 14 6 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.58|-2.62|0.6459
91528224|NCT03688711|182931691|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor, analogous to that used for the primary endpoint analysis. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests. Subjects whose time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) was not met within 45 minutes post-dosing were censored, at the time of the last valid plasma glucose measurement up to 45 minutes.||||<0.0001
91528225|NCT03688711|182931692|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.71|6.05|||ANCOVA|||The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.||6.05|2.71|<0.0001
91695525|NCT01908829|183286189|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.66|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.86|0.66|<0.001
91695526|NCT01908829|183286189|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.021|TWO_SIDED|95.0|0.7|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.97|0.70|=0.021
91695527|NCT01908829|183286189|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.014|TWO_SIDED|95.0|0.71|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.71|=0.014
91695528|NCT01908829|183286190|SUPERIORITY||LS Means|3.86|STANDARD_ERROR_OF_MEAN|2.19|<|0.078|TWO_SIDED|95.0|-0.43|8.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||8.16|-0.43|<0.078
91695529|NCT01908829|183286190|SUPERIORITY||LS Means|11.19|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|5.98|16.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.40|5.98|<0.001
91695530|NCT01908829|183286190|SUPERIORITY||LS Means|12.38|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|6.65|18.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||18.12|6.65|<0.001
91695531|NCT01908829|183286190|SUPERIORITY||LS Means|11.52|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|6.06|16.99||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.99|6.06|<0.001
91695532|NCT01908829|183286191|SUPERIORITY||LS Means|-0.44|STANDARD_ERROR_OF_MEAN|0.15|=|0.003|TWO_SIDED|95.0|-0.73|-0.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.16|-0.73|=0.003
91695533|NCT01908829|183286192|SUPERIORITY||LS Means|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.17|-0.54|<0.001
91695534|NCT01908829|183286192|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.25||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.65|<0.001
91695535|NCT01908829|183286192|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.004|TWO_SIDED|95.0|-0.47|-0.05||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.05|-0.47|=0.004
91695536|NCT01908829|183286192|SUPERIORITY||LS Means|-0.27|STANDARD_ERROR_OF_MEAN|0.1|=|0.003|TWO_SIDED|95.0|-0.47|-0.07||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.47|=0.003
91695537|NCT01908829|183286193|SUPERIORITY||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.76|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.94|0.76|=0.003
91695538|NCT01908829|183286193|SUPERIORITY||Rate Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.63|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.86|0.63|<0.001
91726365|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|-0.35|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.37|-0.35|.96
91726366|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.18|<|0.01|TWO_SIDED|95.0|-0.89|-0.18||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.18|-0.89|<.01
91726367|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.09|0.38||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.38|-0.09|.23
91726368|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9|TWO_SIDED|95.0|-0.25|0.22||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.22|-0.25|.90
91726369|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.38|0.07||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.07|-0.38|.17
91726370|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|95.0|-0.16|0.28||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.28|-0.16|.58
91726371|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.15|TWO_SIDED|95.0|-0.06|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.37|-0.06|.15
91695539|NCT01908829|183286193|SUPERIORITY||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.09|=|0.038|TWO_SIDED|95.0|0.69|0.99||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.99|0.69|=0.038
91758705|NCT00235716|183410638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.46||||0.94|TWO_SIDED|95.0|-3.55|0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.63|-3.55|0.94
91758706|NCT00235716|183410638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.94|TWO_SIDED|95.0|-2.47|1.7||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.70|-2.47|0.94
91758707|NCT00235716|183410638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.94|TWO_SIDED|95.0|-2.57|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-2.57|0.94
91758708|NCT00235716|183410638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.94|TWO_SIDED|95.0|-1.09|3.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.07|-1.09|0.94
91758709|NCT00235716|183410638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.94|TWO_SIDED|95.0|-2.16|1.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.99|-2.16|0.94
91758710|NCT00235716|183410638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.08||||0.94|TWO_SIDED|95.0|-3.14|0.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.99|-3.14|0.94
91758711|NCT00235716|183410639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.79||||0.12|TWO_SIDED|95.0|-3.35|-0.23||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.23|-3.35|0.12
91758712|NCT00235716|183410639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.86|TWO_SIDED|95.0|-1.18|1.94||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.94|-1.18|0.86
91758713|NCT00235716|183410639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.86|TWO_SIDED|95.0|-1.7|1.42||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.42|-1.70|0.86
91758714|NCT00235716|183410639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.14|TWO_SIDED|95.0|0.11|3.19||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.19|0.11|0.14
91758715|NCT00235716|183410639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.86|TWO_SIDED|95.0|-2.07|1.02||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.02|-2.07|0.86
91490275|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.06||||0.0527|TWO_SIDED|90.0|0.63|7.48|||ANCOVA|||Change at Day 14 8 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.48|0.63|0.0527
91695540|NCT01908829|183286193|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.09|=|0.022|TWO_SIDED|95.0|0.69|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.97|0.69|=0.022
91695541|NCT01908829|183286194|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.13|=|0.001|TWO_SIDED|95.0|-0.72|-0.19||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.72|=0.001
91695542|NCT01908829|183286194|SUPERIORITY||LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.93|-0.35||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.35|-0.93|<0.001
91695543|NCT01908829|183286194|SUPERIORITY||LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.15|=|0.001|TWO_SIDED|95.0|-0.82|-0.22||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.82|=0.001
91695544|NCT01908829|183286194|SUPERIORITY||LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.83|-0.25||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.83|<0.001
91695545|NCT01908829|183286195|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.008|TWO_SIDED|95.0|-0.46|-0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.46|=0.008
91695546|NCT01908829|183286195|SUPERIORITY||LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|-0.55|-0.13||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.13|-0.55|=0.002
91695547|NCT01908829|183286195|SUPERIORITY||LS Means|-0.28|STANDARD_ERROR_OF_MEAN|0.1|=|0.006|TWO_SIDED|95.0|-0.47|-0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.08|-0.47|=0.006
91726372|NCT03537729|183347874|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.11|0.29||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.29|-0.11|.37
91490276|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29||||0.1998|TWO_SIDED|90.0|-0.95|7.52|||ANCOVA|||Change at Day 14 10 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.52|-0.95|0.1998
91695548|NCT01908829|183286195|SUPERIORITY||LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.1|=|0.002|TWO_SIDED|95.0|-0.51|-0.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.12|-0.51|=0.002
91695549|NCT01908829|183286196|SUPERIORITY||Rate Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.06|=|0.545|TWO_SIDED|95.0|0.87|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.87|=0.545
91695550|NCT01908829|183286196|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.01|TWO_SIDED|95.0|0.7|0.95||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.95|0.70|=0.010
91695551|NCT01908829|183286196|SUPERIORITY||Rate Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.09|=|0.007|TWO_SIDED|95.0|0.67|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.94|0.67|=0.007
91695552|NCT01908829|183286196|SUPERIORITY||Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.08|=|0.003|TWO_SIDED|95.0|0.66|0.92||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.92|0.66|=0.003
91695553|NCT01908829|183286197|SUPERIORITY||LS Means|-0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.836|TWO_SIDED|95.0|-0.1|0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.08|-0.10|=0.836
91695554|NCT01908829|183286197|SUPERIORITY||LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05|=|0.617|TWO_SIDED|95.0|-0.12|0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.07|-0.12|=0.617
91695555|NCT01908829|183286197|SUPERIORITY||LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.05|=|0.134|TWO_SIDED|95.0|-0.17|0.02||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.02|-0.17|=0.134
91726373|NCT03537729|183347875|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.04|TWO_SIDED|95.0|-0.07|-0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.01|-0.07|.04
91760008|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.37|-0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.02|-0.37|
91760009|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.46|-0.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-0.46|
91726374|NCT03537729|183347875|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1|TWO_SIDED|95.0|-0.07|0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.01|-0.07|.10
91726375|NCT03537729|183347875|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED|95.0|-0.03|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.04|-0.03|.69
91726376|NCT03537729|183347876|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.65||||0.04|TWO_SIDED|95.0|0.44|0.99||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means for two arms was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.99|0.44|0.04
91726377|NCT03537729|183347876|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.59||||0.01|TWO_SIDED|95.0|0.39|0.9||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.90|0.39|.01
91726378|NCT03537729|183347876|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.9||||0.61|TWO_SIDED|95.0|0.6|1.35||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||1.35|0.60|.61
91726379|NCT03537729|183347876|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|1.26||||0.26|TWO_SIDED|95.0|0.84|1.88||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.88|0.84|.26
91490277|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.6765|TWO_SIDED|90.0|-4.22|2.53|||ANCOVA|||Change at Day 15 12 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||2.53|-4.22|0.6765
91490278|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.6221|TWO_SIDED|90.0|-2.35|4.33|||ANCOVA|||Change at Day 15 4 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.33|-2.35|0.6221
91490279|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.3|TWO_SIDED|90.0|-1.11|4.74|||ANCOVA|||Change at Day 15 6 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.74|-1.11|0.3000
91535592|NCT00991276|182949760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.24|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|3.02|7.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.45|3.02|<0.0001
91726380|NCT03537729|183347876|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.79||||0.25|TWO_SIDED|95.0|0.53|1.19||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.19|0.53|.25
91695556|NCT01908829|183286197|SUPERIORITY||LS Means|-0.06|STANDARD_ERROR_OF_MEAN|0.05|=|0.174|TWO_SIDED|95.0|-0.16|0.03||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.03|-0.16|=0.174
91695557|NCT01908829|183286198|SUPERIORITY||Rate Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04|=|0.993|TWO_SIDED|95.0|0.93|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.93|=0.993
91695558|NCT01908829|183286198|SUPERIORITY||Rate Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.04|=|0.736|TWO_SIDED|95.0|0.9|1.07||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.07|0.90|=0.736
91695559|NCT01908829|183286198|SUPERIORITY||Rate Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.05|=|0.121|TWO_SIDED|95.0|0.85|1.02||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.02|0.85|=0.121
91760010|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.45|-0.1||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.10|-0.45|
91760011|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.52|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.52|
91760012|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-0.35|0.0||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.00|-0.35|
91760013|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.53|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.53|
91760014|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.31|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.31|
91760015|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.17|-0.54|
91760016|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.47|-0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.47|
91760017|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.56|-0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.56|
91760018|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.39|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.39|
91760019|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-0.63|
91760020|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.34|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.34|
91695560|NCT01908829|183286198|SUPERIORITY||Rate Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.04|=|0.172|TWO_SIDED|95.0|0.86|1.03||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.03|0.86|=0.172
91695561|NCT01908829|183286204|SUPERIORITY||LS Means|-2.89|STANDARD_ERROR_OF_MEAN|0.91|=|0.002|TWO_SIDED|95.0|-4.68|-1.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-1.10|-4.68|=0.002
91695562|NCT01908829|183286204|SUPERIORITY||LS Means|-4.5|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|-6.4|-2.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-2.60|-6.40|<0.001
91695563|NCT01908829|183286204|SUPERIORITY||LS Means|-5.59|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-7.56|-3.62||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.62|-7.56|<0.001
91695564|NCT01908829|183286204|SUPERIORITY||LS Means|-4.96|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-6.88|-3.04||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.04|-6.88|<0.001
91695565|NCT01908829|183286205|SUPERIORITY||LS Means|1.92|STANDARD_ERROR_OF_MEAN|0.83|=|0.021|TWO_SIDED|95.0|0.29|3.55||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.55|0.29|=0.021
91695566|NCT01908829|183286205|SUPERIORITY||LS Means|2.31|STANDARD_ERROR_OF_MEAN|0.89|=|0.01|TWO_SIDED|95.0|0.56|4.06||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.06|0.56|=0.010
91695567|NCT01908829|183286205|SUPERIORITY||LS Means|3.49|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|1.65|5.33||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.33|1.65|<0.001
91695568|NCT01908829|183286205|SUPERIORITY||LS Means|3.15|STANDARD_ERROR_OF_MEAN|0.92|=|0.001|TWO_SIDED|95.0|1.35|4.95||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.95|1.35|=0.001
91490280|NCT00934089|182852994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.9103|TWO_SIDED|90.0|-3.85|3.37|||ANCOVA|||Change at Day 15 8 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.37|-3.85|0.9103
91490281|NCT00934089|182852996|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|59.2|||<|0.001|TWO_SIDED|95.0|38.69|79.7|||Fisher Exact|||Photophobia: p-value was calculated using fisher exact test.||79.70|38.69|<0.001
91490282|NCT00934089|182852996|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.56||||0.612|TWO_SIDED|95.0|-14.8|7.68|||Fisher Exact|||Iritis: p-value was calculated using fisher exact test.||7.68|-14.80|0.612
91490283|NCT00934089|182852998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.42||||0.245|TWO_SIDED|90.0|-127.05|22.22|||ANCOVA|||Change at Day 13 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||22.22|-127.05|0.2450
91695569|NCT01908829|183286206|SUPERIORITY||LS Means|2.9|STANDARD_ERROR_OF_MEAN|0.96|=|0.003|TWO_SIDED|95.0|1.02|4.78||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.78|1.02|=0.003
91695570|NCT01908829|183286206|SUPERIORITY||LS Means|3.35|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.29|5.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.40|1.29|=0.001
91726381|NCT03537729|183347876|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.63||||0.03|TWO_SIDED|95.0|0.42|0.94||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.94|0.42|.03
91726382|NCT03537729|183347877|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.69||0.31|TWO_SIDED|95.0|-5.03|1.6||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Cues minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||1.60|-5.03|.31
91490284|NCT00934089|182852998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.51||||0.3068|TWO_SIDED|90.0|-21.89|90.91|||ANCOVA|||Change at Day 13 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||90.91|-21.89|0.3068
91490285|NCT00934089|182852998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99||||0.2632|TWO_SIDED|90.0|-19.69|101.67|||ANCOVA|||Change at Day 35 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||101.67|-19.69|0.2632
91490286|NCT00934089|182852998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6||||0.8373|TWO_SIDED|90.0|-60.84|47.64|||ANCOVA|||Change at Day 35 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||47.64|-60.84|0.8373
91490287|NCT00680017|182853011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison."|Wilcoxon rank-sum test|||The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.||||<0.001
91513232|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.75||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.75|0.58|
91513233|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.98||||||95.0|1.81|2.16||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.16|1.81|
91695571|NCT01908829|183286206|SUPERIORITY||LS Means|4.71|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|2.55|6.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.87|2.55|<0.001
91695572|NCT01908829|183286206|SUPERIORITY||LS Means|4.29|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|2.2|6.39||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.39|2.20|<0.001
91695573|NCT01908829|183286207|SUPERIORITY||LS Means|1.94|STANDARD_ERROR_OF_MEAN|0.96|=|0.044|TWO_SIDED|95.0|0.05|3.83||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.83|0.05|=0.044
91695574|NCT01908829|183286207|SUPERIORITY||LS Means|2.5|STANDARD_ERROR_OF_MEAN|1.0|=|0.012|TWO_SIDED|95.0|0.55|4.46||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.46|0.55|=0.012
91695575|NCT01908829|183286207|SUPERIORITY||LS Means|3.61|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.54|5.67||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.67|1.54|=0.001
91513234|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.32||||||95.0|1.18|1.49||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.49|1.18|
91695576|NCT01908829|183286207|SUPERIORITY||LS Means|3.28|STANDARD_ERROR_OF_MEAN|1.03|=|0.001|TWO_SIDED|95.0|1.27|5.29||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.29|1.27|=0.001
91695577|NCT01908829|183286208|SUPERIORITY||LS Means|0.54|STANDARD_ERROR_OF_MEAN|0.96|=|0.575|TWO_SIDED|95.0|-1.35|2.43||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.43|-1.35|=0.575
91695578|NCT01908829|183286208|SUPERIORITY||LS Means|1.61|STANDARD_ERROR_OF_MEAN|1.0|=|0.109|TWO_SIDED|95.0|-0.36|3.58||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.58|-0.36|=0.109
91695579|NCT01908829|183286208|SUPERIORITY||LS Means|2.26|STANDARD_ERROR_OF_MEAN|1.05|=|0.032|TWO_SIDED|95.0|0.2|4.32||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.32|0.20|=0.032
91695580|NCT01908829|183286208|SUPERIORITY||LS Means|1.86|STANDARD_ERROR_OF_MEAN|1.02|=|0.069|TWO_SIDED|95.0|-0.15|3.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.87|-0.15|=0.069
91695581|NCT01908829|183286209|SUPERIORITY||LS Means|1.73|STANDARD_ERROR_OF_MEAN|0.83|=|0.037|TWO_SIDED|95.0|0.1|3.36||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.36|0.10|=0.037
91726383|NCT03537729|183347877|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.75||0.66|TWO_SIDED|95.0|-4.23|2.66||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||2.66|-4.23|.66
91726384|NCT03537729|183347877|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.65||0.57|TWO_SIDED|95.0|-2.3|4.17||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||4.17|-2.30|.57
91726385|NCT02504775|183347926|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|94.704|||||TWO_SIDED|90.0|88.329|101.54|||ANOVA|||||101.540|88.329|
91726386|NCT02504775|183347927|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|95.989|||||TWO_SIDED|90.0|89.826|102.574|||ANOVA|||||102.574|89.826|
91490288|NCT00680017|182853012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 secondary endpoint comparison."|ANCOVA|P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.||The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.||||<0.001
91490289|NCT01948947|182853060|OTHER||||||<|0.0001|||||||ANOVA|||Change from Baseline to 1-Week Post-Treatment||||<0.0001
91490290|NCT01948947|182853060|OTHER||||||<|0.001|||||||ANOVA|||Change from Baseline to 1-Month Post-Treatment||||<0.001
91490291|NCT01948947|182853061|OTHER||||||<|0.001||||||Change from Baseline to 1-Week post-treatment|ANOVA|||||||<0.001
91490292|NCT01948947|182853061|OTHER||||||<|0.01||||||Change from Baseline to 1-Month post-treatment|ANOVA|||||||<0.01
91490293|NCT01948947|182853062|OTHER|||||||0.009|||||||ANOVA|||||||0.009
91528226|NCT01370005|182931721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.72|-0.52||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.52|-0.72|<0.0001
91695582|NCT01908829|183286209|SUPERIORITY||LS Means|1.09|STANDARD_ERROR_OF_MEAN|0.85|=|0.199|TWO_SIDED|95.0|-0.57|2.76||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.76|-0.57|=0.199
91695583|NCT01908829|183286209|SUPERIORITY||LS Means|2.62|STANDARD_ERROR_OF_MEAN|0.87|=|0.003|TWO_SIDED|95.0|0.92|4.31||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.31|0.92|=0.003
91490294|NCT01948947|182853062|OTHER||||||<|0.01||||||Change in Baseline to 1-month post-treatment|ANOVA|||||||<0.01
91490295|NCT01948947|182853063|OTHER||||||=|0.033|||||||ANOVA|||||||=0.033
91490296|NCT03535844|182853065|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|independent t-test of change values||||||0.49
91490297|NCT03535844|182853065|SUPERIORITY|||||||0.5672|||||||t-test, 1 sided|Paired t-test (Week 0 and Week 16)||||||0.5672
91490298|NCT03535844|182853065|SUPERIORITY|||||||0.788|||||||t-test, 2 sided|Paired t-test of change values||||||0.788
91490299|NCT03535844|182853066|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|independent t-test of change values||||||0.67
91490300|NCT03535844|182853066|SUPERIORITY|||||||0.8203|||||||t-test, 2 sided|Paired t-test of change values||||||0.8203
91490301|NCT03535844|182853066|SUPERIORITY|||||||0.3882|||||||t-test, 2 sided|Paired t-test of change values||||||0.3882
91490302|NCT03535844|182853067|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|independent t-test of change values||||||0.08
91490303|NCT03535844|182853068|SUPERIORITY|||||||0.7162|||||||t-test, 2 sided|independent t-test of change values||||||0.7162
91490304|NCT03535844|182853068|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||0.07
91490305|NCT03535844|182853068|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||<0.05
91490306|NCT03535844|182853069|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Independent t-test of change values||||||<0.05
91490307|NCT03535844|182853070|SUPERIORITY|||||||0.4855|||||||t-test, 2 sided|Independent t-test of change triglyceride values||||||0.4855
91490308|NCT03535844|182853070|SUPERIORITY|||||||0.1393|||||||t-test, 2 sided|Independent t-test of change total cholesterol values||||||0.1393
91490309|NCT03535844|182853070|SUPERIORITY|||||||0.2221|||||||t-test, 2 sided|Independent t-test of change LDL cholesterol values||||||0.2221
91490310|NCT03535844|182853070|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|Independent t-test of change HDL cholesterol values||||||0.078
91490311|NCT03535844|182853070|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||<0.05
91490312|NCT03535844|182853070|SUPERIORITY|||||||0.7261|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||0.7261
91490313|NCT03535844|182853071|SUPERIORITY|||||||0.1951|||||||t-test, 2 sided|Independent t-test of systolic blood pressure change values||||||0.1951
91490314|NCT03535844|182853071|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|Independent t-test of diastolic blood pressure change values||||||0.916
91490315|NCT03535844|182853072|SUPERIORITY|||||||0.9882|||||||t-test, 2 sided|independent t-test of malondialdehyde change values||||||0.9882
91490316|NCT03535844|182853073|SUPERIORITY|||||||0.4408|||||||t-test, 2 sided|Independent t-test of body fat % change values||||||0.4408
91490317|NCT03535844|182853074|SUPERIORITY|||||||0.1487|||||||t-test, 2 sided|Independent t-test of change values||||||0.1487
91695584|NCT01908829|183286209|SUPERIORITY||LS Means|2.48|STANDARD_ERROR_OF_MEAN|0.85|=|0.004|TWO_SIDED|95.0|0.81|4.15||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.15|0.81|=0.004
91695585|NCT01908829|183286210|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|<0.001
91695586|NCT01908829|183286210|SUPERIORITY||LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.1|=|0.019|TWO_SIDED|95.0|0.0|0.5||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.5|0.0|=0.019
91695587|NCT01908829|183286210|SUPERIORITY||LS Means|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.3|0.7||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.7|0.3|<0.001
91695588|NCT01908829|183286210|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|=|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|=0.001
91695589|NCT01908829|183286211|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
91695590|NCT01908829|183286211|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
91695591|NCT01908829|183286211|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.2||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.2|-0.4|<0.001
91695592|NCT01908829|183286211|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
91490318|NCT03535844|182853075|SUPERIORITY|||||||0.9135|||||||t-test, 2 sided|Independent t-test of change values||||||0.9135
91490319|NCT03535844|182853076|SUPERIORITY|||||||0.5859|||||||t-test, 2 sided|Independent t-test of change values||||||0.5859
91695593|NCT01908829|183286213|SUPERIORITY||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.19|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.19|<0.001
91695594|NCT01908829|183286213|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.25|<0.001
91695595|NCT01908829|183286213|SUPERIORITY||Odds Ratio (OR)|1.54|||=|0.001|TWO_SIDED|95.0|1.21|1.95||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.95|1.21|=0.001
91695596|NCT01908829|183286213|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.001|TWO_SIDED|95.0|1.2|1.9||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.90|1.20|<0.001
91695597|NCT01908829|183286214|SUPERIORITY||Odds Ratio (OR)|1.24|||=|0.119|TWO_SIDED|95.0|0.95|1.63||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.63|0.95|=0.119
91726387|NCT02504775|183347928|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|106.132|||||TWO_SIDED|90.0|85.151|132.283|||ANOVA|||||132.283|85.151|
91726388|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.367|TWO_SIDED||||||Fisher Exact|||All bleeds||||.367
91726389|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Fisher Exact|||All bleeds||||.104
91490320|NCT03535844|182853077|SUPERIORITY|||||||0.9379|||||||t-test, 2 sided|Independent t-test of change values||||||0.9379
91726390|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Fisher Exact|||All bleeds||||.864
91490321|NCT03535844|182853078|SUPERIORITY|||||||0.9717|||||||t-test, 2 sided|t-test of change values||||||0.9717
91490322|NCT03535844|182853081|SUPERIORITY|||||||0.7052|||||||t-test, 2 sided|Independent t-test of change values||||||0.7052
91490323|NCT03535844|182853081|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test between Week 0 and Week 16 endothelin-1 concentrations||||||0.07
91490324|NCT03535844|182853081|SUPERIORITY|||||||0.005||||||Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|t-test, 2 sided|||||||0.005
91490325|NCT03535844|182853082|SUPERIORITY|||||||0.9426||||||Independent t-test of change values|t-test, 2 sided|||||||0.9426
91490326|NCT05096221|182853123|SUPERIORITY||Least squares mean change difference|0.65|STANDARD_ERROR_OF_MEAN|0.55||0.2441|TWO_SIDED|95.0|-0.45|1.74|||Mixed model of repeated measures|||||1.74|-0.45|0.2441
91726391|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||All bleeds||||.002
91726392|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||1.000
91726393|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.029
91726394|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.807
91726395|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.002
91490327|NCT05096221|182853124|OTHER||||||<|0.0001|||||||Re-randomization test|||||||< 0.0001
91490328|NCT05096221|182853125|SUPERIORITY||Least squares mean change difference|-0.64|STANDARD_ERROR_OF_MEAN|0.21||0.0025|TWO_SIDED|95.0|-1.06|-0.23|||Mixed model of repeated measures|||||-0.23|-1.06|0.0025
91490329|NCT05096221|182853126|SUPERIORITY||Least squares mean change difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.0048|TWO_SIDED|95.0|-0.71|-0.13|||Mixed model of repeated measures|||||-0.13|-0.71|0.0048
91490330|NCT05096221|182853127|SUPERIORITY||Least squares mean change difference|-3.29|STANDARD_ERROR_OF_MEAN|2.52||0.1942|TWO_SIDED|95.0|-8.28|1.7|||Mixed model of repeated measures|||||1.70|-8.28|0.1942
91490331|NCT05096221|182853128|SUPERIORITY||Least squares mean change difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0412|TWO_SIDED|95.0|-0.71|-0.01|||Mixed model of repeated measures|||||-0.01|-0.71|0.0412
91490332|NCT05096221|182853129|SUPERIORITY||Least squares mean change difference|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0402|TWO_SIDED|95.0|0.0|0.19|||Mixed model of repeated measures|||||0.19|0.00|0.0402
91726396|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
91726397|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.119
91726398|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
91726399|NCT00504556|183347978|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.023
91726400|NCT01623752|183348066|OTHER|||||||0.278|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.278
91726401|NCT01623752|183348066|OTHER|||||||0.222|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.222
91726402|NCT01623752|183348067|OTHER|||||||0.251|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.251
91695598|NCT01908829|183286214|SUPERIORITY||Odds Ratio (OR)|1.56|||<|0.001|TWO_SIDED|95.0|1.23|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.23|<0.001
91695599|NCT01908829|183286214|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.002|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.002
91695600|NCT01908829|183286214|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.001|TWO_SIDED|95.0|1.17|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.17|=0.001
91695601|NCT01908829|183286215|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.305|TWO_SIDED|95.0|0.88|1.5||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.50|0.88|=0.305
91695602|NCT01908829|183286215|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.014|TWO_SIDED|95.0|1.06|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.06|=0.014
91695603|NCT01908829|183286215|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.012|TWO_SIDED|95.0|1.07|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.07|=0.012
91695604|NCT01908829|183286215|SUPERIORITY||Odds Ratio (OR)|1.29|||=|0.036|TWO_SIDED|95.0|1.02|1.64||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.64|1.02|=0.036
91695605|NCT01908829|183286216|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.001|TWO_SIDED|95.0|1.18|1.88||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.88|1.18|=0.001
91695606|NCT01908829|183286216|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.31|2.18||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.18|1.31|<0.001
91695607|NCT01908829|183286216|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.47|2.61||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.61|1.47|<0.001
91695608|NCT01908829|183286216|SUPERIORITY||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.34|2.3||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.30|1.34|<0.001
91726403|NCT01623752|183348067|OTHER|||||||0.218|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.218
91726404|NCT01623752|183348070|OTHER|||||||0.675|||||||Regression, Linear|||||||0.675
91726405|NCT01623752|183348070|OTHER|||||||0.357|||||||Regression, Linear|||||||0.357
91726406|NCT01623752|183348071|OTHER|||||||0.106|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.106
91726407|NCT01623752|183348071|OTHER|||||||0.181|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.181
91726408|NCT01623752|183348072|OTHER|||||||0.015|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.015
91726409|NCT01623752|183348072|OTHER|||||||0.969|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.969
91726410|NCT01623752|183348073|OTHER|||||||0.489|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.489
91726411|NCT01623752|183348073|OTHER|||||||0.386|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.386
91726412|NCT01623752|183348074|OTHER|||||||0.364|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.364
91490333|NCT05096221|182853130|SUPERIORITY||Least squares mean change difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4272|TWO_SIDED|95.0|-0.08|0.19|||Mixed model of repeated measures|||||0.19|-0.08|0.4272
91695609|NCT01908829|183286217|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.003|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.003
91695610|NCT01908829|183286217|SUPERIORITY||Odds Ratio (OR)|1.51|||=|0.001|TWO_SIDED|95.0|1.18|1.93||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.93|1.18|=0.001
91695611|NCT01908829|183286217|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.27|2.13||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.13|1.27|<0.001
91695612|NCT01908829|183286217|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.001|TWO_SIDED|95.0|1.17|1.91||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.91|1.17|=0.001
91695613|NCT01908829|183286218|SUPERIORITY||Odds Ratio (OR)|1.42|||=|0.003|TWO_SIDED|95.0|1.13|1.79||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.13|=0.003
91695614|NCT01908829|183286218|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.004|TWO_SIDED|95.0|1.12|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.12|=0.004
91695615|NCT01908829|183286218|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.003|TWO_SIDED|95.0|1.15|1.96||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.96|1.15|=0.003
91695616|NCT01908829|183286218|SUPERIORITY||Odds Ratio (OR)|1.43|||=|0.006|TWO_SIDED|95.0|1.11|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.11|=0.006
91695617|NCT01908829|183286219|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.065|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.66|0.99|=0.065
91726413|NCT01623752|183348074|OTHER|||||||0.849|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.849
91726414|NCT05987540|183348105|SUPERIORITY|||||||0.8125|||||||Wilcoxon matched-pairs signed rank|||||||.8125
91726415|NCT05987540|183348108|SUPERIORITY||||||>|0.9999|||||||Wilconxon matched-pairs signed rank test|||||||>0.9999
91726416|NCT04053452|183348109|OTHER||Area under the curve|0.7262|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
91726417|NCT04053452|183348110|OTHER||Area under the curve|0.6667|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
91726418|NCT04053452|183348111|OTHER||Area under the curve|0.7083|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
91726419|NCT04053452|183348112|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.0623|||||TWO_SIDED|95.0|-0.5005|0.4791||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4791|-0.5005|
91726420|NCT04053452|183348112|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.1628|||||TWO_SIDED|95.0|-0.6503|0.4222||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4222|-0.6503|
91726421|NCT04053452|183348112|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.185|||||TWO_SIDED|95.0|-0.549|0.1829||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1829|-0.5490|
91726422|NCT04053452|183348112|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.0512|||||TWO_SIDED|95.0|-0.3411|0.5017||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5017|-0.3411|
91726423|NCT04053452|183348112|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.0476|||||TWO_SIDED|95.0|-0.4335|0.5592||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5592|-0.4335|
91490334|NCT05096221|182853131|SUPERIORITY||Least squares mean change difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7324|TWO_SIDED|95.0|-0.24|0.17|||Mixed model of repeated measures|||||0.17|-0.24|0.7324
91726424|NCT04053452|183348112|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.1229|||||TWO_SIDED|95.0|-0.5092|0.304||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3040|-0.5092|
91726425|NCT04053452|183348112|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.0603|||||TWO_SIDED|95.0|-0.3057|0.4137||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4137|-0.3057|
91490335|NCT05096221|182853132|SUPERIORITY||Least squares mean change difference|0.19|STANDARD_ERROR_OF_MEAN|0.44||0.6554|TWO_SIDED|95.0|-0.67|1.06|||Mixed model of repeated measures|||||1.06|-0.67|0.6554
91695618|NCT01908829|183286219|SUPERIORITY||Odds Ratio (OR)|1.41|||=|0.004|TWO_SIDED|95.0|1.11|1.79|||Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.11|=0.004
91695619|NCT01908829|183286219|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.3|2.07|||Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.07|1.30|<0.001
91695620|NCT01908829|183286219|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.001|TWO_SIDED|95.0|1.24|1.94|||Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.94|1.24|<0.001
91695621|NCT01430403|183286236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.331||0.03|TWO_SIDED|95.0|0.25|0.92|||Odds Ratio|Adjusted for Site, dosing group and treatment step|Placebo serves as the reference group. Values \< 1 represent more exacerbations in the placebo arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||0.92|0.25|0.03
91695622|NCT01430403|183286237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|95.0|0.33|1.64|||Odds Ratio|Adjusted for Site, dosing group and treatment step|ICS Boost serves as the reference group. Values \< 1 represent more exacerbations in the ICS arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||1.64|0.33|0.45
91695623|NCT01430403|183286238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.01|TWO_SIDED|95.0|2.38|5.22|||Chi-squared||Adjusted for site|||5.22|2.38|<0.01
91695624|NCT01430403|183286239|SUPERIORITY_OR_OTHER||Linear Regression|0.004||||0.94|TWO_SIDED|95.0|-0.1|0.11|||F-Test|||||0.11|-0.10|0.94
91695625|NCT01430403|183286239|SUPERIORITY_OR_OTHER||Linear Regression|-0.13||||0.33|TWO_SIDED|95.0|-0.4|0.13|||F-Test|||||0.13|-0.40|0.33
91695626|NCT01430403|183286240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.552|TWO_SIDED|95.0|0.87|1.31|||Chi-squared|||||1.31|0.87|0.552
91695627|NCT01430403|183286240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.37|TWO_SIDED|95.0|0.87|1.44|||Chi-squared|||||1.44|0.87|0.37
91695628|NCT01430403|183286241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.3||0.09|TWO_SIDED|95.0|-1.11|0.07|||Regression, Linear|Adjustments for randomization CASI, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.07|-1.11|0.09
91695629|NCT01430403|183286242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.86|0.34|||Regression, Linear|Adjustments for randomization CASI, site and dosing group||||0.34|-0.86|0.39
91695630|NCT01430403|183286243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|1.58||0.84|TWO_SIDED|95.0|-3.42|2.78|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.78|-3.42|0.84
91695631|NCT01430403|183286244|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.59||0.14|TWO_SIDED|95.0|-0.76|5.51|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site and dosing group.||||5.51|-0.76|0.14
91695632|NCT01430403|183286245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.49|1.99|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.99|-1.49|0.78
91695633|NCT01430403|183286246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|0.89||0.2|TWO_SIDED|95.0|-0.61|2.91|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site and dosing group.||||2.91|-0.61|0.20
91695634|NCT01430403|183286247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.4||0.006|TWO_SIDED|95.0|0.32|1.9|||Regression, Linear|Adjustments for randomization ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.90|0.32|0.006
91490336|NCT01589978|182853158|NON_INFERIORITY_OR_EQUIVALENCE|Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.||||<.0001
91490337|NCT01589978|182853178|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).||||<.0001
91490338|NCT02197273|182853215|SUPERIORITY_OR_OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.764
91490339|NCT02197273|182853216|SUPERIORITY_OR_OTHER|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||||||0.206
91490340|NCT02197273|182853217|SUPERIORITY_OR_OTHER||Fisher exact|0.486||||0.656|TWO_SIDED||||||Fisher Exact|||||||0.656
91490341|NCT00005044|182853218|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.45|TWO_SIDED|95.0|0.48|1.39|||Log Rank||Reference level = TAS x 8 weeks|Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.||1.39|0.48|0.45
91695635|NCT01430403|183286248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.41||0.89|TWO_SIDED|95.0|-0.76|0.86|||Regression, Linear|Adjustments for randomization ACT, site and dosing group.||||0.86|-0.76|0.89
91695636|NCT01430403|183286249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.36||0.05|TWO_SIDED|95.0|0.0|1.41|||Regression, Linear|Adjustments for randomization C-ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.41|0.00|0.05
91695637|NCT01430403|183286250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.12|TWO_SIDED|95.0|-0.15|1.3|||Regression, Linear|Adjustments for randomization C-ACT, site and dosing group||||1.30|-0.15|0.12
91695638|NCT01430403|183286251|SUPERIORITY_OR_OTHER||Rate Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.68||0.63|TWO_SIDED|95.0|0.19|0.72|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.72|0.19|0.63
91695639|NCT01430403|183286252|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.63||0.99|TWO_SIDED|95.0|0.29|3.46|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||3.46|0.29|0.99
91695640|NCT01430403|183286253|SUPERIORITY_OR_OTHER||Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.32||0.31|TWO_SIDED|95.0|0.39|1.35|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.35|0.39|0.31
91695641|NCT01430403|183286254|SUPERIORITY_OR_OTHER||Ratio|0.48|STANDARD_ERROR_OF_MEAN|0.39||0.06|TWO_SIDED|95.0|0.23|1.02|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||1.02|0.23|0.06
91695642|NCT01430403|183286255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.08|2.72|||Regression, Linear|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.72|-3.08|0.90
91695643|NCT01430403|183286256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.52||0.86|TWO_SIDED|95.0|-3.26|2.71|||Regression, Linear|Adjustments for site and dosing group.||||2.71|-3.26|0.86
91695644|NCT02677922|183286264|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0003|TWO_SIDED|95.0|1.99|11.85|||Chi-squared|||||11.85|1.99|0.0003
91695645|NCT02677922|183286267|SUPERIORITY||Cox Proportional Hazard|0.59||||0.1083|TWO_SIDED|95.0|0.3|1.13|||Log Rank|||||1.13|0.30|0.1083
91695646|NCT02677922|183286269|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|2.74|27.31|||Chi-squared|||||27.31|2.74|<0.001
91695647|NCT02677922|183286270|SUPERIORITY||Odds Ratio (OR)|1.77||||0.1943|TWO_SIDED|95.0|0.74|4.2|||Chi-squared|||||4.20|0.74|0.1943
91695648|NCT02677922|183286273|SUPERIORITY||Cox Proportional Hazard|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Log Rank|Unstratified log-rank test|Cox proportional hazards regression model|||1.87|0.52|0.9720
91695649|NCT02677922|183286274|OTHER|Confidence interval of difference|Difference|2.6|||||TWO_SIDED|95.0|-17.3|22.5|||||The CI for the difference was derived using Greenwood's variance estimate.|||22.5|-17.3|
91695650|NCT00637000|183286289|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|The statistical method used was a group by time repeated measures model with a first-order autoregressive covariance structure||To test the primary study hypothesis that neither soluble film formulation would precipitate an opioid withdrawal syndrome, peak COWS score in the 23.5 hour period after the initial soluble film administration were compared to pre-administration baseline COWS scores (30 minutes prior to soluble film administration) using a group by time repeated measures model with a first-order autoregressive covariance structure.||||<0.0001
91695651|NCT00637000|183286290|SUPERIORITY_OR_OTHER|||||||0|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.000
91695652|NCT00637000|183286291|SUPERIORITY_OR_OTHER|||||||0.035||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.035
91695653|NCT00637000|183286292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91695654|NCT00637000|183286293|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91528227|NCT01370005|182931721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.75|-0.55||Hierarchical testing, no adjustment of p-values|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.55|-0.75|<0.0001
91695655|NCT00637000|183286294|SUPERIORITY_OR_OTHER|||||||0.006||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.006
91695656|NCT00637000|183286295|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91695657|NCT00637000|183286296|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91695658|NCT00637000|183286297|SUPERIORITY_OR_OTHER|||||||0.762||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.762
91695659|NCT00637000|183286298|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91695660|NCT00637000|183286299|SUPERIORITY_OR_OTHER|||||||0.349||||||The p-value is not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.349
91695661|NCT00637000|183286300|SUPERIORITY_OR_OTHER|||||||0.028||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.028
91695662|NCT00637000|183286301|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91695663|NCT00637000|183286302|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91695664|NCT00637000|183286303|SUPERIORITY_OR_OTHER|||||||0.117||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.117
91695665|NCT00637000|183286304|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
91726426|NCT04053452|183348112|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.1059|||||TWO_SIDED|95.0|-0.4028|0.57||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5700|-0.4028|
91726427|NCT04053452|183348112|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.1786|||||TWO_SIDED|95.0|-0.6503|0.2838||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.2838|-0.6503|
91726428|NCT04053452|183348112|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.2396|||||TWO_SIDED|95.0|-0.5714|0.195||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1950|-0.5714|
91490342|NCT00005044|182853219|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.62|TWO_SIDED|95.0|0.79|1.15|||Log Rank|2-sided significance level of 0.05|Reference level = TAS x 8 weeks|With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.||1.15|0.79|0.62
91490343|NCT00005044|182853220|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.85|1.08|||Log Rank|Significance level = 0.05|Reference level = TAS x 8 weeks|||1.08|0.85|0.47
91695666|NCT00637000|183286305|SUPERIORITY_OR_OTHER|||||||0.238||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.238
91695667|NCT03660189|183286307|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
91695668|NCT03660189|183286307|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
91726429|NCT04053452|183348112|OTHER|C6|Kendall's tau correlation coefficient|-0.0671|||||TWO_SIDED|95.0|-0.4667|0.3336||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3336|-0.4667|
91726430|NCT04053452|183348112|OTHER|C7|Kendall's tau correlation coefficient|-0.2134|||||TWO_SIDED|95.0|-0.7018|0.3193||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3193|-0.7018|
91726431|NCT04053452|183348112|OTHER|Vagus|Kendall's tau correlation coefficient|0.0246|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4596|-0.3506|
91695669|NCT03660189|183286309|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91695670|NCT03660189|183286312|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
91695671|NCT03660189|183286313|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
91695672|NCT03660189|183286317|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91695673|NCT03660189|183286318|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91695674|NCT04513080|183286319|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from baseline to week 6||||
91695675|NCT04513080|183286319|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from week 6 to week 12||||
91695676|NCT04513080|183286320|SUPERIORITY||Mean Difference (Final Values)|0.53|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from baseline to week 6||||
91695677|NCT04513080|183286320|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from week 6 to week 12||||
91695678|NCT04513080|183286320|SUPERIORITY||Mean Difference (Final Values)|0.44|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from baseline to week 6||||
91695679|NCT04513080|183286320|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from week 6 to week 12||||
91726432|NCT04053452|183348113|OTHER|Median at wrist|Odds Ratio (OR)|0.7686494||||0.36|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.360
91726433|NCT04053452|183348113|OTHER|Median at forearm|Odds Ratio (OR)|0.9315228||||0.521|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.521
91726434|NCT04053452|183348113|OTHER|Median at cubital fossa|Odds Ratio (OR)|0.7949528||||0.245|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.245
91726435|NCT04053452|183348113|OTHER|Median at humerus|Odds Ratio (OR)|0.8603349||||0.541|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.541
91726436|NCT04053452|183348113|OTHER|Median at axilla|Odds Ratio (OR)|0.8767973||||0.415|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.415
91726437|NCT04053452|183348113|OTHER|Ulnar at wrist|Odds Ratio, log|0.7613965||||0.504|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.504
91726438|NCT04053452|183348113|OTHER|Ulnar at forearm|Odds Ratio (OR)|0.8061505||||0.393|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.393
91726439|NCT04053452|183348113|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|0.8336885||||0.222|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.222
91726440|NCT04053452|183348113|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.1214848||||0.615|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.615
91726441|NCT04053452|183348113|OTHER|Ulnar at axilla|Odds Ratio (OR)|0.9898411||||0.926|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.926
91726442|NCT04053452|183348113|OTHER|C6|Odds Ratio (OR)|0.9402829||||0.519|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.519
91726443|NCT04053452|183348113|OTHER|C7|Odds Ratio (OR)|0.9347906||||0.379|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.379
91726444|NCT04053452|183348113|OTHER|Vagus|Odds Ratio (OR)|0.8968658||||0.511|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.511
91726445|NCT04053452|183348114|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.057735|||||TWO_SIDED|95.0|-0.4273|0.3293||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3293|-0.4273|
91726446|NCT04053452|183348114|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.0359442|||||TWO_SIDED|95.0|-0.548|0.5248||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5248|-0.5480|
91726447|NCT04053452|183348114|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.1429483|||||TWO_SIDED|95.0|-0.1938|0.4763||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.4763|-0.1938|
91726448|NCT04053452|183348114|OTHER|Median at humerus|Kendall's tau correlation coefficient|-0.3955939|||||TWO_SIDED|95.0|-0.6811|-0.0874||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.0874|-0.6811|
91726449|NCT04053452|183348114|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.3681051|||||TWO_SIDED|95.0|-0.7032|0.1185||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.1185|-0.7032|
91726450|NCT04053452|183348114|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.4938292|||||TWO_SIDED|95.0|-0.7112|-0.1978||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.1978|-0.7112|
91726451|NCT04053452|183348114|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.1304373|||||TWO_SIDED|95.0|-0.2201|0.5014||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5014|-0.2201|
91726452|NCT04053452|183348114|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.3273268|||||TWO_SIDED|95.0|-0.0679|0.6612||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.6612|-0.0679|
91726453|NCT04053452|183348114|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.0552157|||||TWO_SIDED|95.0|-0.4213|0.361||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3610|-0.4213|
91726454|NCT04053452|183348114|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.1666667|||||TWO_SIDED|95.0|-0.5389|0.2057||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2057|-0.5389|
91726455|NCT04053452|183348114|OTHER|C6|Kendall's tau correlation coefficient|-0.3194892|||||TWO_SIDED|95.0|-0.6539|0.2288||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2288|-0.6539|
91726456|NCT04053452|183348114|OTHER|C7|Kendall's tau correlation coefficient|-0.4959498|||||TWO_SIDED|95.0|-0.686|-0.2065||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.2065|-0.6860|
91726457|NCT04053452|183348114|OTHER|Vagus|Kendall's tau correlation coefficient|-0.3228883|||||TWO_SIDED|95.0|-0.6487|0.0||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.0000|-0.6487|
91726458|NCT04053452|183348115|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.1415346|||||TWO_SIDED|95.0|-0.735|0.4247||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4247|-0.7350|
91726459|NCT04053452|183348115|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1987845|||||TWO_SIDED|95.0|-0.4377|0.8004||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.8004|-0.4377|
91726460|NCT04053452|183348115|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.0789747|||||TWO_SIDED|95.0|-0.5256|0.3778||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.3778|-0.5256|
91726461|NCT04053452|183348115|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.1621509|||||TWO_SIDED|95.0|-0.3591|0.5606||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5606|-0.3591|
91726462|NCT04053452|183348115|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.1499412|||||TWO_SIDED|95.0|-0.3901|0.6374||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6374|-0.3901|
91726463|NCT04053452|183348115|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0140441|||||TWO_SIDED|95.0|-0.5773|0.5407||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5407|-0.5773|
91726464|NCT04053452|183348115|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.01383297|||||TWO_SIDED|95.0|-0.5288|0.5485||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5485|-0.5288|
91726465|NCT04053452|183348115|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.2935683|||||TWO_SIDED|95.0|-0.6968|0.2414||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.2414|-0.6968|
91726466|NCT04053452|183348115|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.1067521|||||TWO_SIDED|95.0|-0.5204|0.6392||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6392|-0.5204|
91726467|NCT04053452|183348115|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.0549235|||||TWO_SIDED|95.0|-0.4633|0.5594||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5594|-0.4633|
91535593|NCT00991276|182949760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.56|STANDARD_ERROR_OF_MEAN|1.11||0.1622|TWO_SIDED|95.0|-0.64|3.75||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.75|-0.64|0.1622
91726468|NCT04053452|183348115|OTHER|C6|Kendall's tau correlation coefficient|-0.2597622|||||TWO_SIDED|95.0|-0.6816|0.1857||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.1857|-0.6816|
91726469|NCT04053452|183348115|OTHER|C7|Kendall's tau correlation coefficient|-0.0129034|||||TWO_SIDED|95.0|-0.4476|0.4025||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4025|-0.4476|
91726470|NCT04053452|183348115|OTHER|Vagus|Kendall's tau correlation coefficient|0.02457737|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4596|-0.3506|
91726471|NCT04053452|183348116|OTHER|Median at wrist|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
91726472|NCT04053452|183348116|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
91726473|NCT04053452|183348116|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.09040847|||||TWO_SIDED|95.0|-0.3821|0.5979||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5979|-0.3821|
91726474|NCT04053452|183348116|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.02501955|||||TWO_SIDED|95.0|-0.4158|0.479||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4790|-0.4158|
91726475|NCT04053452|183348116|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.0349215|||||TWO_SIDED|95.0|-0.5033|0.443||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4430|-0.5033|
91726476|NCT04053452|183348116|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0961|||||TWO_SIDED|95.0|-0.5458|0.4037||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4037|-0.5458|
91726477|NCT04053452|183348116|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|-0.2239171|||||TWO_SIDED|95.0|-0.6514|0.2935||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2935|-0.6514|
91726478|NCT04053452|183348116|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.0805076|||||TWO_SIDED|95.0|-0.5371|0.2974||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2974|-0.5371|
91726479|NCT04053452|183348116|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.2910126|||||TWO_SIDED|95.0|-0.2791|0.7651||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.7651|-0.2791|
91726480|NCT04053452|183348116|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.02342428|||||TWO_SIDED|95.0|-0.4531|0.5267||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5267|-0.4531|
91726481|NCT04053452|183348116|OTHER|C6|Kendall's tau correlation coefficient|0.06536087|||||TWO_SIDED|95.0|-0.2786|0.4454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4454|-0.2786|
91726482|NCT04053452|183348116|OTHER|C7|Kendall's tau correlation coefficient|0.2207792|||||TWO_SIDED|95.0|-0.2459|0.6708||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6708|-0.2459|
91726483|NCT04053452|183348116|OTHER|Vagus|Kendall's tau correlation coefficient|0.14415|||||TWO_SIDED|95.0|-0.2333|0.4899||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4899|-0.2333|
91726484|NCT04053452|183348117|OTHER|Median at wrist|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
91726485|NCT04053452|183348117|OTHER|Median at forearm|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
91726486|NCT04053452|183348117|OTHER|Median at cubital fossa|Odds Ratio (OR)|1.23944918||||0.25|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.250
91726487|NCT04053452|183348117|OTHER|Median at humerus|Odds Ratio (OR)|0.9613236||||0.874|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.874
91726488|NCT04053452|183348117|OTHER|Median at axilla|Odds Ratio (OR)|0.9442314||||0.698|TWO_SIDED|95.0|||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.698
91726489|NCT04053452|183348117|OTHER|Ulnar at wrist|Odds Ratio (OR)|1.193941||||0.665|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.665
91726490|NCT04053452|183348117|OTHER|Ulnar at forearm|Odds Ratio (OR)|1.0524489||||0.82|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.820
91726491|NCT04053452|183348117|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|1.21669122||||0.193|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.193
91726492|NCT04053452|183348117|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.2994068||||0.314|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.314
91726493|NCT04053452|183348117|OTHER|Ulnar at axilla|Odds Ratio (OR)|1.1015629||||0.405|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.405
91726494|NCT04053452|183348117|OTHER|C6|Odds Ratio (OR)|0.9140133||||0.389|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.389
91726495|NCT04053452|183348117|OTHER|C7|Odds Ratio (OR)|0.7982946||||0.139|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.139
91726496|NCT04053452|183348117|OTHER|Vagus|Odds Ratio (OR)|0.9330042||||0.622|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.622
91726497|NCT04053452|183348118|OTHER|Median at wrist, 3 months|Kendall's tau correlation coefficient|0.2641183|||||TWO_SIDED|95.0|-0.2344|0.7511||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.7511|-0.2344|
91726498|NCT04053452|183348118|OTHER|Median at forearm, 3 months|Kendall's tau correlation coefficient|0.02596308|||||TWO_SIDED|95.0|-0.4859|0.5555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.5555|-0.4859|
91726499|NCT04053452|183348118|OTHER|Median at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.05162687|||||TWO_SIDED|95.0|-0.3342|0.417||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4170|-0.3342|
91726500|NCT04053452|183348118|OTHER|Median at humerus, 3 months|Kendall's tau correlation coefficient|-0.1714461|||||TWO_SIDED|95.0|-0.6473|0.2723||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.2723|-0.6473|
91726501|NCT04053452|183348118|OTHER|Median at axilla, 3 months|Kendall's tau correlation coefficient|-0.0531775|||||TWO_SIDED|95.0|-0.583|0.4451||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4451|-0.5830|
91726502|NCT04053452|183348118|OTHER|Ulnar at wrist, 3 months|Kendall's tau correlation coefficient|0.1371924|||||TWO_SIDED|95.0|-0.3592|0.6944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6944|-0.3592|
91726503|NCT04053452|183348118|OTHER|Ulnar at forearm, 3 months|Kendall's tau correlation coefficient|-0.0134595|||||TWO_SIDED|95.0|-0.5145|0.4627||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4627|-0.5145|
91726504|NCT04053452|183348118|OTHER|Ulnar at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.01313517|||||TWO_SIDED|95.0|-0.5056|0.4833||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4833|-0.5056|
91695680|NCT04513080|183286320|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from baseline to week 6||||
91695681|NCT04513080|183286320|SUPERIORITY||Mean Difference (Final Values)|0.68|||||TWO_SIDED|||||||||Mean difference comparing difference in average scores from week 6 to week 12||||
91695682|NCT00403481|183286339|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
91695683|NCT00403481|183286340|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 for both daytime and nighttime. No multiplicity adjustments.|one-sample t-test|||||||<0.0001
91695684|NCT00403481|183286341|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
91695685|NCT00403481|183286342|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||0.0001
91695686|NCT00403481|183286344|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
91695687|NCT00403481|183286345|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both the daytime and nighttime analyses|one-sample t-test|||||||<0.0001
91695688|NCT00403481|183286346|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
91695689|NCT00403481|183286347|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both 4 hour and 6 hour analyses|one-sample t-test|||||||<0.0001
91695690|NCT02477332|183286391|SUPERIORITY||Estimated target dose|32.5|||<|0.05|TWO_SIDED|60.0|27.5|42.5|||Regression, Logistic|Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.|Min dose with effect size \>15%|||42.5|27.5|<.05
91695691|NCT02977572|183286417|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Based upon previous results, the investigators considered that the need for an intubation could be reduced by 15% \[19% in the CPAP group (control) vs. 4% in the NIV group (study)\]. The estimated sample size was 55 participants in each group (confidence interval \[1-α\] = 90% and power \[1-β\] = 85%).||||1.000
91695692|NCT01075256|183286427|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1||||0.3628|TWO_SIDED|95.0|-6.7|2.46||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||2.46|-6.70|0.3628
91490344|NCT00005044|182853221|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.07|TWO_SIDED|95.0|0.4|1.05|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Locoregional progression||1.05|0.40|0.07
91695693|NCT01075256|183286427|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.9361|TWO_SIDED|95.0|-4.45|4.83||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.83|-4.45|0.9361
91695694|NCT01075256|183286427|SUPERIORITY_OR_OTHER||Adjusted Mean difference|2.3||||0.3257|TWO_SIDED|95.0|-2.31|6.92||No adustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.92|-2.31|0.3257
91695695|NCT01075256|183286428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.6674|TWO_SIDED|95.0|-5.73|3.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||3.68|-5.73|0.6674
91695696|NCT01075256|183286428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9888|TWO_SIDED|95.0|-4.74|4.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.81|-4.74|0.9888
91695697|NCT01075256|183286428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1||||0.6599|TWO_SIDED|95.0|-3.69|5.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.81|-3.69|0.6599
91695698|NCT01075256|183286429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1||||0.9759|TWO_SIDED|95.0|-6.34|6.54||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.54|-6.34|0.9759
91695699|NCT01075256|183286429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.8903|TWO_SIDED|95.0|-6.97|6.06||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.06|-6.97|0.8903
91695700|NCT01075256|183286429|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6||||0.8662|TWO_SIDED|95.0|-7.04|5.93||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.||5.93|-7.04|0.8662
91726505|NCT04053452|183348118|OTHER|Ulnar at humerus, 3 months|Kendall's tau correlation coefficient|-0.1196495|||||TWO_SIDED|95.0|-0.5876|0.3467||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3467|-0.5876|
91726506|NCT04053452|183348118|OTHER|Ulnar at axilla, 3 months|Kendall's tau correlation coefficient|0.0|||||TWO_SIDED|95.0|-0.3682|0.3885||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3885|-0.3682|
91726507|NCT04053452|183348118|OTHER|C6, 3 months|Kendall's tau correlation coefficient|0.1194695|||||TWO_SIDED|95.0|-0.422|0.6686||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6686|-0.4220|
91726508|NCT04053452|183348118|OTHER|C7, 3 months|Kendall's tau correlation coefficient|-0.0593456|||||TWO_SIDED|95.0|-0.5651|0.454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4540|-0.5651|
91695701|NCT01075256|183286430|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8419|TWO_SIDED|95.0|-6.93|5.66||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.66|-6.93|0.8419
91726509|NCT04053452|183348118|OTHER|Vagus, 3 months|Kendall's tau correlation coefficient|-0.1920694|||||TWO_SIDED|95.0|-0.549|0.238||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.238|-0.5490|
91490345|NCT00005044|182853221|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.8|TWO_SIDED|95.0|0.68|1.66|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Distant metastasis||1.66|0.68|0.80
91490346|NCT00005044|182853222|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.74|TWO_SIDED|95.0|0.89|1.17|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Protocol definition||1.17|0.89|0.74
91490347|NCT00005044|182853222|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.79|1.19|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Phoenix definition||1.19|0.79|0.77
91490348|NCT00005044|182853223|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.62|TWO_SIDED|95.0|0.64|1.3|||Log Rank|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|||1.30|0.64|0.62
91490349|NCT00843856|182853225|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.7
91490350|NCT03104543|182853227|SUPERIORITY||Risk Ratio (RR)|0.99||||0.05|TWO_SIDED|95.0|0.67|1.45|||Generalized estimating equation|||||1.45|0.67|.05
91490351|NCT03104543|182853230|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.47|0.28|||t-test, 2 sided|||||0.28|-0.47|.05
91490352|NCT02993757|182853233|OTHER||GMT ratio|0.982|||||TWO_SIDED|95.0|0.664|1.45||||||Antigen HPV-6||1.45|0.664|
91490353|NCT02993757|182853233|OTHER||GMT ratio|0.804|||||TWO_SIDED|95.0|0.626|1.03||||||Antigen HPV-11||1.03|0.626|
91490354|NCT02993757|182853233|OTHER||GMT ratio|0.815|||||TWO_SIDED|95.0|0.608|1.09||||||Antigen HPV-16||1.09|0.608|
91490355|NCT02993757|182853233|OTHER||GMT ratio|0.795|||||TWO_SIDED|95.0|0.603|1.05||||||Antigen HPV-18||1.05|0.603|
91490356|NCT02993757|182853234|OTHER||GMT ratio|0.987|||||TWO_SIDED|95.0|0.574|1.7||||||Serotype 1||1.70|0.574|
91490357|NCT02993757|182853234|OTHER||GMT ratio|0.783|||||TWO_SIDED|95.0|0.5|1.22||||||Serotype 2||1.22|0.500|
91490358|NCT02993757|182853234|OTHER||GMT ratio|0.836|||||TWO_SIDED|95.0|0.568|1.23||||||Serotype 3||1.23|0.568|
91490359|NCT02993757|182853234|OTHER||GMT ratio|1.07|||||TWO_SIDED|95.0|0.813|1.4||||||Serotype 4||1.40|0.813|
91490360|NCT00087607|182853251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.978|TWO_SIDED|95.0|-0.35|0.36|||t-test, 2 sided|||Mean treatment difference was tested using a two-sided t-test.||0.36|-0.35|0.978
91490361|NCT00087607|182853252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.08|TWO_SIDED|95.0|-0.03|0.58|||t-test, 2 sided|||At Week 4: Mean treatment difference was tested using a two-sided t-test.||0.58|-0.03|0.080
91490362|NCT00087607|182853252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.688|TWO_SIDED|95.0|-0.27|0.41|||t-test, 2 sided|||At Week 8: Mean treatment difference was tested using a two-sided t-test.||0.41|-0.27|0.688
91490363|NCT00087607|182853256|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANOVA|||The treatment groups were compared using an analysis of variance (ANOVA) with treatment as the only factor in the model.||||0.304
91490364|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.1||||0.2814|TWO_SIDED|95.0|-8.6|2.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||2.5|-8.6|0.2814
91490365|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.3||||0.0214|TWO_SIDED|95.0|-18.9|-1.6|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||-1.6|-18.9|0.0214
91490366|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.7||||0.0315|TWO_SIDED|95.0|-20.3|-1.0|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||-1.0|-20.3|0.0315
91490367|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-7.4||||0.1467|TWO_SIDED|95.0|-17.4|2.6|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||2.6|-17.4|0.1467
91695702|NCT01075256|183286430|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.9147|TWO_SIDED|95.0|-6.03|6.72||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.72|-6.03|0.9147
91695703|NCT01075256|183286430|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0||||0.76|TWO_SIDED|95.0|-5.36|7.33||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.33|-5.36|0.7600
91695704|NCT01075256|183286431|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.5||||0.9124|TWO_SIDED|95.0|-8.28|9.24||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.24|-8.28|0.9124
91695705|NCT01075256|183286431|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.9083|TWO_SIDED|95.0|-9.13|8.14||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level||8.14|-9.13|0.9083
91695706|NCT01075256|183286431|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.8231|TWO_SIDED|95.0|-9.73|7.77||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.77|-9.73|0.8231
91695707|NCT01075256|183286432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.4||||0.5946|TWO_SIDED|95.0|-9.32|16.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||16.09|-9.32|0.5946
91695708|NCT01075256|183286432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-12.51|12.6||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||12.60|-12.51|0.9944
91726510|NCT04053452|183348118|OTHER|Median at wrist, 6 months|Kendall's tau correlation coefficient|0.3150905|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
91726511|NCT04053452|183348118|OTHER|Median at forearm, 6 months|Kendall's tau correlation coefficient|0.1203751|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
91726512|NCT04053452|183348118|OTHER|Median at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2526605|||||TWO_SIDED|95.0|-0.1865|0.643||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6430|-0.1865|
91726513|NCT04053452|183348118|OTHER|Median at humerus, 6 months|Kendall's tau correlation coefficient|-0.073601|||||TWO_SIDED|95.0|-0.5806|0.4223||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.4223|-0.5806|
91726514|NCT04053452|183348118|OTHER|Median at axilla, 6 months|Kendall's tau correlation coefficient|0.01369735|||||TWO_SIDED|95.0|-0.5619|0.5236||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5236|-0.5619|
91726515|NCT04053452|183348118|OTHER|Ulnar at wrist, 6 months|Kendall's tau correlation coefficient|0.2685663|||||TWO_SIDED|95.0|-0.2488|0.7683||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7683|-0.2488|
91726516|NCT04053452|183348118|OTHER|Ulnar at forearm, 6 months|Kendall's tau correlation coefficient|0.1802776|||||TWO_SIDED|95.0|-0.2573|0.6027||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6027|-0.2573|
91726517|NCT04053452|183348118|OTHER|Ulnar at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2571327|||||TWO_SIDED|95.0|-0.2595|0.6227||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6227|-0.2595|
91726518|NCT04053452|183348118|OTHER|Ulnar at humerus, 6 months|Kendall's tau correlation coefficient|-0.0684867|||||TWO_SIDED|95.0|-0.5757|0.3944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3944|-0.5757|
91726519|NCT04053452|183348118|OTHER|Ulnar at axilla, 6 months|Kendall's tau correlation coefficient|0.1929429|||||TWO_SIDED|95.0|-0.1828|0.555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5550|-0.1828|
91726520|NCT04053452|183348118|OTHER|C6, 6 months|Kendall's tau correlation coefficient|0.1975146|||||TWO_SIDED|95.0|-0.3557|0.7344||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7344|-0.3557|
91726521|NCT04053452|183348118|OTHER|C7, 6 months|Kendall's tau correlation coefficient|-0.0754722|||||TWO_SIDED|95.0|-0.615|0.5083||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5083|-0.6150|
91726522|NCT04053452|183348118|OTHER|Vagus, 6 months|Kendall's tau correlation coefficient|-0.0706753|||||TWO_SIDED|95.0|-0.5042|0.3963||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3963|-0.5042|
91726523|NCT01421134|183348119|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-10.2|-4.8|||Mixed Models Analysis|||||-4.8|-10.2|<0.0001
91726524|NCT01421134|183348120|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-0.96|-0.34|||Mixed Models Analysis|||||-0.34|-0.96|<0.0001
91726525|NCT01421134|183348121|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||Mixed Models Analysis|||||-1.1|-3.1|<0.0001
91726526|NCT01421134|183348122|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||ANCOVA|||||-2.4|-7.2|0.0001
91726527|NCT01421134|183348123|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.1|-2.9|||ANCOVA|||||-2.9|-6.1|<0.0001
91726528|NCT01421134|183348124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.615|||<|0.0001|TWO_SIDED|95.0|3.251|13.459|||Regression, Logistic||Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.|||13.459|3.251|<0.0001
91726529|NCT01421134|183348125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.27|||<|0.0001|TWO_SIDED|95.0|2.105|8.663|||Regression, Logistic|||||8.663|2.105|<0.0001
91726530|NCT06083493|183348157|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91490368|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.8||||0.1823|TWO_SIDED|95.0|-16.9|3.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||3.2|-16.9|0.1823
91726531|NCT06083493|183348158|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
91726532|NCT01810952|183348196|SUPERIORITY_OR_OTHER|||||||0.35||||||This is the p-value for Day 5|t-test, 2 sided|||||||0.35
91726533|NCT01810952|183348197|SUPERIORITY_OR_OTHER|||||||0.65|||||||Chi-squared|||||||0.65
91726534|NCT01810952|183348198|SUPERIORITY_OR_OTHER|||||||0.06||||||Comparison of the 5 day averages resulted in a p-value of 0.06.|t-test, 2 sided|||Daily values for each protocol were compared using t-tests.||||0.06
91726535|NCT01810952|183348199|SUPERIORITY_OR_OTHER||difference in binomial proportions|||||0.795||||||Comparison of the number of participants in each group with glucose value \<70 mg/dL resulted in p-value 0.795.|Chi-squared|||||||0.795
91726536|NCT01810952|183348200|SUPERIORITY_OR_OTHER|||||||0.055||||||Comparison between groups of percent of glucose values \>180 mg/dL.|Chi-squared|||Values in each group were compared by Chi squared.||||0.055
91726537|NCT02618187|183348220|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.766|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.766
91726538|NCT02618187|183348220|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.037|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.037
91726539|NCT02618187|183348220|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.313|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.313
91726540|NCT02618187|183348220|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.384|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.384
91490369|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.1||||0.6871|TWO_SIDED|95.0|-12.1|8.0|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||8.0|-12.1|0.6871
91490370|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.4||||0.9295|TWO_SIDED|95.0|-10.4|9.5|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||9.5|-10.4|0.9295
91490371|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6593|TWO_SIDED|95.0|-7.6|12.1|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||12.1|-7.6|0.6593
91490372|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6637|TWO_SIDED|95.0|-7.7|12.1|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||12.1|-7.7|0.6637
91490373|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.276|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2760
91490374|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.2779|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2779
91726541|NCT02618187|183348220|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.237|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.237
91726542|NCT02618187|183348221|SUPERIORITY|Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority||||||0.257|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.257
91726543|NCT02618187|183348221|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
91726544|NCT02618187|183348221|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
91726545|NCT02618187|183348221|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority||||||0.009|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.009
91726546|NCT02618187|183348221|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority||||||0.168|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.168
91490375|NCT00087607|182853258|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.8||||0.5697|TWO_SIDED|95.0|-6.8|12.4|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||12.4|-6.8|0.5697
91490376|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|0.0||||0.994|TWO_SIDED|95.0|-1.4|1.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||1.5|-1.4|0.9940
91490377|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.5||||0.7133|TWO_SIDED|95.0|-3.2|2.2|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||2.2|-3.2|0.7133
91490378|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.6||||0.0864|TWO_SIDED|95.0|-7.8|0.5|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||0.5|-7.8|0.0864
91490379|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.1||||0.1713|TWO_SIDED|95.0|-10.0|1.8|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||1.8|-10.0|0.1713
91490380|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.6||||0.1888|TWO_SIDED|95.0|-11.4|2.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||2.2|-11.4|0.1888
91490381|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.6||||0.108|TWO_SIDED|95.0|-14.7|1.4|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||1.4|-14.7|0.1080
91726547|NCT02618187|183348222|SUPERIORITY||Rate difference (SER-287 - placebo)|13.3||||0.4923|TWO_SIDED|95.0|-3.87|30.54|||Fisher Exact|||||30.54|-3.87|0.4923
91726548|NCT02618187|183348222|SUPERIORITY||Rate difference (SER-287 - placebo)|40.0||||0.0237|TWO_SIDED|95.0|15.21|64.79|||Fisher Exact|||||64.79|15.21|0.0237
91726549|NCT02618187|183348222|SUPERIORITY||Rate difference (SER-287 - placebo)|17.6||||0.2579|TWO_SIDED|95.0|-0.47|35.77|||Fisher Exact|||||35.77|-0.47|0.2579
91726550|NCT02618187|183348223|SUPERIORITY||Rate difference (SER-287 - placebo)|24.2||||0.1973|TWO_SIDED|95.0|-5.04|53.53|||Fisher Exact|||||53.53|-5.04|0.1973
91726551|NCT02618187|183348223|SUPERIORITY||Rate difference (SER-287 - placebo)|30.9||||0.1783|TWO_SIDED|95.0|0.86|60.96|||Fisher Exact|||||60.96|0.86|0.1783
91726552|NCT02618187|183348223|SUPERIORITY||Rate difference (SER-287 - placebo)|14.4||||0.6195|TWO_SIDED|95.0|-11.93|40.81|||Fisher Exact|||||40.81|-11.93|0.6195
91490382|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.5||||0.3099|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||4.2|-13.1|0.3099
91490383|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.4||||0.4595|TWO_SIDED|95.0|-12.4|5.6|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||5.6|-12.4|0.4595
91490384|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.0||||0.2144|TWO_SIDED|95.0|-15.4|3.4|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||3.4|-15.4|0.2144
91490385|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-5.4||||0.2779|TWO_SIDED|95.0|-15.1|4.3|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||4.3|-15.1|0.2779
91490386|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.7||||0.5876|TWO_SIDED|95.0|-12.6|7.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||7.1|-12.6|0.5876
91726553|NCT03055507|183348262|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.05|TWO_SIDED|96.0|-2.4|0.5|||t-test, 1 sided|||||0.5|-2.4|<0.05
91726554|NCT04560309|183348274|SUPERIORITY|||||||0.993||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.993
91726555|NCT04560309|183348275|SUPERIORITY|||||||0.883||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.883
91726556|NCT04560309|183348276|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.034
91726557|NCT04560309|183348277|SUPERIORITY|||||||0.038||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.038
91726558|NCT04560309|183348278|SUPERIORITY|||||||0.423||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.423
91726559|NCT04560309|183348279|SUPERIORITY|||||||0.216||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.216
91726560|NCT04560309|183348280|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.001
91726561|NCT04560309|183348281|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.043
91695709|NCT01075256|183286432|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.3||||0.5998|TWO_SIDED|95.0|-16.06|9.38||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.38|-16.06|0.5998
91695710|NCT01075256|183286433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7952|TWO_SIDED|95.0|-10.51|8.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.09|-10.51|0.7952
91695711|NCT01075256|183286433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4||||0.601|TWO_SIDED|95.0|-11.56|6.76||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.76|-11.56|0.6010
91695712|NCT01075256|183286433|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7976|TWO_SIDED|95.0|-10.48|8.1||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.10|-10.48|0.7976
91695713|NCT01075256|183286434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7||||0.906|TWO_SIDED|95.0|-10.38|11.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||11.68|-10.38|0.9060
91695714|NCT01075256|183286434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7||||0.7575|TWO_SIDED|95.0|-12.63|9.25||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.25|-12.63|0.7575
91726562|NCT04560309|183348282|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.011
91726563|NCT04560309|183348283|SUPERIORITY|||||||0.975||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.975
91726564|NCT04560309|183348284|SUPERIORITY|||||||0.031||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.031
91490387|NCT00087607|182853259|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.8||||0.3399|TWO_SIDED|95.0|-14.7|5.1|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||5.1|-14.7|0.3399
91695715|NCT01075256|183286434|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.3||||0.6727|TWO_SIDED|95.0|-13.42|8.73||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.73|-13.42|0.6727
91695716|NCT02115581|183286437|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.267
91695717|NCT02115581|183286438|SUPERIORITY_OR_OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
91726565|NCT04560309|183348285|SUPERIORITY|||||||0.549||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.549
91726566|NCT04560309|183348286|SUPERIORITY|||||||0.645||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.645
91726567|NCT04560309|183348287|SUPERIORITY|||||||0.33||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||After induction to anesthesia||||0.330
91726568|NCT04560309|183348287|SUPERIORITY|||||||0.352||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||5 minutes after cardiopulmonary bypass||||0.352
91726569|NCT04560309|183348287|SUPERIORITY|||||||0.544||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||2 hours after cardiopulmonary bypass||||0.544
91726570|NCT04560309|183348287|SUPERIORITY|||||||0.022||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||6 hours after cardiopulmonary bypass||||0.022
91726571|NCT04560309|183348287|SUPERIORITY|||||||0.038||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||24 hour after cardiopulmonary bypass||||0.038
91726572|NCT04560309|183348288|SUPERIORITY|||||||0.2||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.200
91726573|NCT04560309|183348289|SUPERIORITY|||||||0.72||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.720
91726574|NCT04560309|183348290|SUPERIORITY|||||||0.042||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.042
91726575|NCT04560309|183348291|SUPERIORITY|||||||0.044||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.044
91695718|NCT01294241|183286439|SUPERIORITY_OR_OTHER||||||=|0.008||||||Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|Two-sided exact binomial test|||The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0||||=0.008
91695719|NCT01294241|183286440|SUPERIORITY_OR_OTHER||||||=|0.21||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||=0.21
91695720|NCT01294241|183286441|SUPERIORITY_OR_OTHER|||||||0.33||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||0.33
91695721|NCT02748213|183286455|SUPERIORITY_OR_OTHER||Difference in Response Rates|2.2||||0.717|TWO_SIDED|95.0|-10.17|14.56|||Chi-squared||The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.|||14.56|-10.17|0.717
91695722|NCT02748213|183286457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0449|TWO_SIDED|95.0|0.53|0.99|||Log Rank||Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.|||0.99|0.53|0.0449
91695723|NCT02748213|183286459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4758|TWO_SIDED|95.0|0.56|1.32|||Log Rank||HR calculated using Herceptin + Taxotere arm as reference.|||1.32|0.56|0.4758
91695724|NCT03291431|183286480|OTHER|Chi-Square comparison of frequencies|Pearson Chi-Square|0.17||||0.99|TWO_SIDED|||||A p-value of \<0.05 is considered statistically significant.|Chi-squared|||||||0.99
91695725|NCT03291431|183286481|OTHER||Slope|-0.2||||0.68|TWO_SIDED|95.0||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|Linear mixed modeling||||0.68
91695726|NCT03291431|183286482|OTHER|||||||0.34||||||p-value \< .05 considered statistically significant.|Mixed Models Analysis|||||||0.34
91695727|NCT03291431|183286483|OTHER|Linear mixed modeling|Slope|-1.99||||0.7|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|||||0.70
91695728|NCT03291431|183286484|OTHER||Slope|0.3||||0.11|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis|||Linear mixed modeling||||0.11
91695729|NCT03850483|183286485|SUPERIORITY||Least square (LS) mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1641|TWO_SIDED|90.0|-1.71|0.43||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.43|-1.71|0.1641
91695730|NCT03850483|183286485|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.65||0.61|TWO_SIDED|90.0|-0.89|1.26||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||1.26|-0.89|0.6100
91695731|NCT03850483|183286485|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1686|TWO_SIDED|90.0|-1.7|0.45||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.45|-1.70|0.1686
91695732|NCT03850483|183286485|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1051|TWO_SIDED|90.0|-1.87|0.25||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.25|-1.87|0.1051
91695733|NCT03850483|183286485|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.3583|TWO_SIDED|90.0|-1.37|0.88||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.88|-1.37|0.3583
91695734|NCT03850483|183286485|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.1131|TWO_SIDED|90.0|-1.88|0.29||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.29|-1.88|0.1131
91695735|NCT03850483|183286485|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.64||0.1812|TWO_SIDED|90.0|-1.64|0.47||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.47|-1.64|0.1812
91695736|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
91695737|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|8.5||||0.243|TWO_SIDED|90.0|-6.6|25.9|||Chan and Zhang method|||||25.9|-6.6|0.2430
91695738|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
91695739|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|14.5||||0.0665|TWO_SIDED|0.0665|-1.3|31.5|||Chan and Zhang method|||||31.5|-1.3|0.0665
91695740|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|6.1||||0.3423|TWO_SIDED|90.0|-12.1|25.5|||Chan and Zhang method|||||25.5|-12.1|0.3423
91695741|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|12.9||||0.1271|TWO_SIDED|90.0|-4.7|30.9|||Chan and Zhang method|||||30.9|-4.7|0.1271
91726576|NCT04560309|183348292|SUPERIORITY|||||||0.349||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.349
91490388|NCT00087607|182853264|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Repeated measures analysis|The P-value is determined from a repeated measures analysis with terms for treatment group, baseline, week, and the week-by-treatment interaction.||Week 1: The treatment groups were compared using repeated measures analysis||||0.024
91490389|NCT00087607|182853264|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated measures analysis|||Week 8: The treatment groups were compared using Repeated measures analysis||||<0.001
91528228|NCT01370005|182931722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.78|-2.09||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.09|-4.78|<0.0001
91695742|NCT03850483|183286486|SUPERIORITY||Risk Difference (RD)|3.2||||0.401|TWO_SIDED|90.0|-13.2|21.1|||Chan and Zhang method|||||21.1|-13.2|0.4010
91695743|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4225|TWO_SIDED|90.0|-11.2|10.4|||Chan and Zhang method|||Week 1||10.4|-11.2|0.4225
91695744|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 1||5.0|-14.0|0.7483
91695745|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
91695746|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
91695747|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-6.4|8.9|||Chan and Zhang method|||Week 1||8.9|-6.4|0.5000
91695748|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|2.9||||0.2125|TWO_SIDED|90.0|-3.4|13.2|||Chan and Zhang method|||Week 1||13.2|-3.4|0.2125
91695749|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|2.7||||0.2267|TWO_SIDED|90.0|-3.5|12.2|||Chan and Zhang method|||Week 1||12.2|-3.5|0.2267
91695750|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7592|TWO_SIDED|90.0|-14.0|4.6|||Chan and Zhang method|||Week 2||4.6|-14.0|0.7592
91695751|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7299|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 2||5.5|-14.0|0.7299
91695752|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4463|TWO_SIDED|90.0|-11.3|9.4|||Chan and Zhang method|||Week 2||9.4|-11.3|0.4463
91695753|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 2||4.8|-14.0|0.7539
91695754|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-2.2||||0.7009|TWO_SIDED|90.0|-10.1|5.9|||Chan and Zhang method|||Week 2||5.9|-10.1|0.7009
91695755|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|4.0||||0.2507|TWO_SIDED|90.0|-4.5|15.6|||Chan and Zhang method|||Week 2||15.6|-4.5|0.2507
91695756|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|3.5||||0.2993|TWO_SIDED|90.0|-4.8|14.3|||Chan and Zhang method|||Week 2||14.3|-4.8|0.2993
91695757|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7363|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 4||5.5|-14.0|0.7363
91695758|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|0.4||||0.5369|TWO_SIDED|90.0|-10.5|12.3|||Chan and Zhang method|||Week 4||12.3|-10.5|0.5369
91695759|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
91695760|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
91695761|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-2.2||||0.599|TWO_SIDED|90.0|-13.7|11.6|||Chan and Zhang method|||Week 4||11.6|-13.7|0.5990
91695762|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-5.9||||0.7926|TWO_SIDED|90.0|-16.4|4.9|||Chan and Zhang method|||Week 4||4.9|-16.4|0.7926
91695763|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|3.2||||0.3402|TWO_SIDED|90.0|-9.0|17.6|||Chan and Zhang method|||Week 4||17.6|-9.0|0.3402
91695764|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.2||||0.7364|TWO_SIDED|90.0|-14.4|5.7|||Chan and Zhang method|||Week 6||5.7|-14.4|0.7364
91695765|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|4.2||||0.3009|TWO_SIDED|90.0|-7.4|17.7|||Chan and Zhang method|||Week 6||17.7|-7.4|0.3009
91695766|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|3.2||||0.34|TWO_SIDED|90.0|-8.1|15.9|||Chan and Zhang method|||Week 6||15.9|-8.1|0.3400
91695767|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|7.1||||0.1631|TWO_SIDED|90.0|-4.8|21.1|||Chan and Zhang method|||Week 6||21.1|-4.8|0.1631
91695768|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
91695769|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
91695770|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.5||||0.6413|TWO_SIDED|90.0|-17.9|11.7|||Chan and Zhang method|||Week 6||11.7|-17.9|0.6413
91490390|NCT02015754|182853284|OTHER|||||||0.004||||||Differences of p-value \< 0.05 considered statistically significant.|Regression, Cox|||Multivariate Cox-regression analysis to identify independent prognostic factors for overall survival from baseline characteristics. Relative risk with 95% confidence intervals calculated as measure of association.||||0.004
91490391|NCT02015754|182853291|OTHER|VEGF immediately post treatment||||||0.6257|||||||one-sample Wilcoxon signed rank test|||||||0.6257
91490392|NCT02015754|182853291|OTHER|VEGF at 24 hours post treatment.||||||0.4143|||||||one-sample Wilcoxon signed rank test|||||||0.4143
91490393|NCT02015754|182853291|OTHER|VEGFR1 immediately post treatment.||||||0.583|||||||one-sample Wilcoxon signed rank test|||||||0.583
91490394|NCT02015754|182853291|OTHER|VEGFR1 at 24 hours post treatment.||||||0.0012|||||||one-sample Wilcoxon signed rank test|||||||.0012
91490395|NCT02015754|182853291|OTHER|VEGFR2 immediately post treatment.||||||0.1353|||||||one-sample Wilcoxon signed rank test|||||||0.1353
91695771|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-13.1|13.1|||Chan and Zhang method|||Week 8||13.1|-13.1|0.5000
91695772|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|0.7||||0.5134|TWO_SIDED|90.0|-12.6|15.2|||Chan and Zhang method|||Week 8||15.2|-12.6|0.5134
91695773|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4468|TWO_SIDED|90.0|-13.4|12.5|||Chan and Zhang method|||Week 8||12.5|-13.4|0.4468
91695774|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|7.6||||0.2778|TWO_SIDED|90.0|-6.8|23.9|||Chan and Zhang method|||Week 8||23.9|-6.8|0.2778
91695775|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|2.1||||0.4571|TWO_SIDED|90.0|-14.5|21.0|||Chan and Zhang method|||Week 8||21.0|-14.5|0.4571
91695776|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4741|TWO_SIDED|90.0|-15.3|16.7|||Chan and Zhang method|||Week 8||16.7|-15.3|0.4741
91695777|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|0.4||||0.5153|TWO_SIDED|90.0|-14.8|16.7|||Chan and Zhang method|||Week 8||16.7|-14.8|0.5153
91695778|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-7.0||||0.8287|TWO_SIDED|90.0|-21.1|5.3|||Chan and Zhang method|||Week 10||5.3|-21.1|0.8287
91695779|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-2.3||||0.5675|TWO_SIDED|90.0|-17.8|14.2|||Chan and Zhang method|||Week 10||14.2|-17.8|0.5675
91695780|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|6.9||||0.2648|TWO_SIDED|90.0|-9.8|23.2|||Chan and Zhang method|||Week 10||23.2|-9.8|0.2648
91695781|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|3.9||||0.3792|TWO_SIDED|90.0|-11.8|20.8|||Chan and Zhang method|||Week 10||20.8|-11.8|0.3792
91695782|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|2.7||||0.4438|TWO_SIDED|90.0|-16.3|23.1|||Chan and Zhang method|||Week 10||23.1|-16.3|0.4438
91695783|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-7.5||||0.7014|TWO_SIDED|90.0|-23.3|9.4|||Chan and Zhang method|||Week 10||9.4|-23.3|0.7014
91490396|NCT02015754|182853291|OTHER|VEGFR2 at 24 hours post treatment.||||||0.2163|||||||one-sample Wilcoxon signed rank test|||||||0.2163
91695784|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-2.8||||0.5841|TWO_SIDED|90.0|-19.7|15.0|||Chan and Zhang method|||Week 10||15.0|-19.7|0.5841
91695785|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-15.3|15.3|||Chan and Zhang method|||Week 12||15.3|-15.3|0.5000
91695786|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5834|TWO_SIDED|90.0|-17.5|12.3|||Chan and Zhang method|||Week 12||12.3|-17.5|0.5834
91695787|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|10.3||||0.1534|TWO_SIDED|90.0|-6.4|27.2|||Chan and Zhang method|||Week 12||27.2|-6.4|0.1534
91695788|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|7.5||||0.272|TWO_SIDED|90.0|-8.8|24.9|||Chan and Zhang method|||Week 12||24.9|-8.8|0.2720
91695789|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-8.1||||0.6815|TWO_SIDED|90.0|-25.1|10.4|||Chan and Zhang method|||Week 12||10.4|-25.1|0.6815
91695790|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|3.5||||0.39|TWO_SIDED|90.0|-14.4|22.0|||Chan and Zhang method|||Week 12||22.0|-14.4|0.3900
91695791|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5865|TWO_SIDED|90.0|-20.0|15.9|||Chan and Zhang method|||Week 12||15.9|-20.0|0.5865
91695792|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|4.2||||0.3087|TWO_SIDED|90.0|-8.2|18.9|||Chan and Zhang method|||Week 14||18.9|-8.2|0.3087
91695793|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|5.2||||0.3137|TWO_SIDED|90.0|-8.2|20.9|||Chan and Zhang method|||Week 14||20.9|-8.2|0.3137
91695794|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|18.0||||0.0245|TWO_SIDED|90.0|2.7|34.8|||Chan and Zhang method|||Week 14||34.8|2.7|0.0245
91695795|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|10.8||||0.1119|TWO_SIDED|90.0|-3.0|26.0|||Chan and Zhang method|||Week 14||26.0|-3.0|0.1119
91695796|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|2.7||||0.414|TWO_SIDED|90.0|-13.2|20.4|||Chan and Zhang method|||Week 14||20.4|-13.2|0.4140
91695797|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|9.7||||0.2356|TWO_SIDED|90.0|-7.2|28.5|||Chan and Zhang method|||Week 14||28.5|-7.2|0.2356
91695798|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|4.5||||0.3638|TWO_SIDED|90.0|-11.5|21.5|||Chan and Zhang method|||Week 14||21.5|-11.5|0.3638
91695799|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|7.7||||0.1613|TWO_SIDED|90.0|-5.2|22.9|||Chan and Zhang method|||Week 16||22.9|-5.2|0.1613
91695800|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|13.9||||0.0557|TWO_SIDED|90.0|-0.5|31.4|||Chan and Zhang method|||Week 16||31.4|-0.5|0.0557
91490397|NCT02229383|182853294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.94|-0.54|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.54|-0.94|<0.001
91490398|NCT02229383|182853295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.341|<|0.001|TWO_SIDED|95.0|-2.19|-0.85|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.85|-2.19|<0.001
91490399|NCT02229383|182853296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.76|STANDARD_ERROR_OF_MEAN|5.754|<|0.001|TWO_SIDED|95.0|-39.07|-16.45|||ANCOVA|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.||||-16.45|-39.07|<0.001
91490400|NCT02229383|182853297|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
91490401|NCT02229383|182853298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.074|TWO_SIDED|95.0|-4.1|0.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.2|-4.1|0.074
91490402|NCT02229383|182853299|SUPERIORITY_OR_OTHER||Difference in percentages|20.0|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
91490403|NCT02229383|182853300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.13||0.11|TWO_SIDED|95.0|-4.0|0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.4|-4.0|0.110
91490404|NCT05764408|182853318|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.49|1.35||||||||1.35|0.49|
91490405|NCT05764408|182853319|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.39|1.86||||||||1.86|0.39|
91490406|NCT05764408|182853320|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
91490407|NCT05764408|182853322|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
91490408|NCT05764408|182853323|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.07|16.12||||||||16.12|0.07|
91490409|NCT06934993|182853330|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
91490410|NCT06934993|182853331|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In all cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
91490411|NCT06934993|182853331|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
91490412|NCT06934993|182853331|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
91490413|NCT06934993|182853332|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
91490414|NCT06934993|182853332|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
91490415|NCT06934993|182853333|SUPERIORITY|||||||0.04||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.04
91695801|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|21.6||||0.0114|TWO_SIDED|90.0|5.6|38.3|||Chan and Zhang method|||Week 16||38.3|5.6|0.0114
91490416|NCT06934993|182853333|SUPERIORITY|||||||0.679||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.679
91490417|NCT06934993|182853333|SUPERIORITY|||||||0.011||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.011
91490418|NCT01218113|182853334|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|0.801|||||TWO_SIDED|97.5|0.553|1.162|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.||1.162|0.553|
91695802|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|11.9||||0.0753|TWO_SIDED|90.0|-1.8|28.1|||Chan and Zhang method|||Week 16||28.1|-1.8|0.0753
91726577|NCT04560309|183348293|SUPERIORITY|||||||0.95||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.950
91726578|NCT04560309|183348294|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.862|||||||Wilcoxon (Mann-Whitney)|||||||0.862
91726579|NCT04560309|183348295|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.075|||||||Wilcoxon (Mann-Whitney)|||||||0.075
91726580|NCT01860404|183348302|SUPERIORITY|||||||0.871|||||||Kruskal-Wallis|||||||0.871
91726581|NCT01860404|183348303|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.140
91726582|NCT01860404|183348304|SUPERIORITY|||||||0.267|||||||Kruskal-Wallis|||||||0.267
91726583|NCT01860404|183348305|SUPERIORITY|||||||0.476|||||||Kruskal-Wallis|||||||0.476
91726584|NCT01860404|183348306|SUPERIORITY|||||||0.581|||||||Kruskal-Wallis|||||||0.581
91726585|NCT01860404|183348307|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
91726586|NCT01860404|183348308|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91726587|NCT01860404|183348309|SUPERIORITY|||||||0.482|||||||Kruskal-Wallis|||||||0.482
91726588|NCT01860404|183348310|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
91726589|NCT01860404|183348311|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||||||0.629
91726590|NCT01860404|183348312|SUPERIORITY|||||||0.624|||||||Regression, Linear|||||||0.624
91726591|NCT01860404|183348313|SUPERIORITY|||||||0.2554|||||||Regression, Linear|||||||0.2554
91726592|NCT01860404|183348314|SUPERIORITY|||||||0.7964|||||||Regression, Linear|||||||0.7964
91726593|NCT01860404|183348315|SUPERIORITY|||||||0.7749|||||||Regression, Linear|||||||0.7749
91726594|NCT01860404|183348316|SUPERIORITY|||||||0.0036|||||||Regression, Linear|||||||0.0036
91726595|NCT01860404|183348317|SUPERIORITY|||||||0.0053|||||||Regression, Linear|||||||0.0053
91726596|NCT01860404|183348318|SUPERIORITY|||||||0.8234|||||||Regression, Linear|||||||0.8234
91726597|NCT02187055|183348348|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-7.73||||0.2101|TWO_SIDED|98.34|-16.29|0.83|||Normal approximation to proportions|Multiplicity-adjusted||||0.83|-16.29|0.2101
91726598|NCT02187055|183348348|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-5.5||||0.0512|TWO_SIDED|98.34|-13.98|2.98|||Normal approximation to proportions|Multiplicity-adjusted||||2.98|-13.98|0.0512
91726599|NCT02187055|183348348|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|2.23|||<|0.0001|TWO_SIDED|98.34|-6.4|10.86|||Normal approximation to proportions|Multiplicity adjusted||||10.86|-6.40|<0.0001
91695803|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.1||||0.5635|TWO_SIDED|90.0|-20.1|15.2|||Chan and Zhang method|||Week 16||15.2|-20.1|0.5635
91726600|NCT02187055|183348349|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||||TWO_SIDED|95.0|1.23|4.41||||||||4.41|1.23|
91726601|NCT02187055|183348349|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.33|3.49||||||||3.49|0.33|
91490419|NCT01218113|182853334|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|1.184|||||TWO_SIDED|97.5|0.816|1.717|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||1.717|0.816|
91490420|NCT01218113|182853335|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Mean Difference|-0.096|||||TWO_SIDED|97.5|-0.257|0.065|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.065|-0.257|
91490421|NCT01218113|182853335|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Mean Difference|0.073|||||TWO_SIDED|97.5|-0.088|0.235|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.235|-0.088|
91490422|NCT00967668|182853399|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|Linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables||All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.||||<0.05
91490423|NCT03281577|182853404|SUPERIORITY||Least Squares Mean Differences|-25.81||||0.0012|TWO_SIDED|95.0|-41.757|-9.858||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as covariate.|||-9.858|-41.757|0.0012
91726602|NCT02187055|183348349|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.51|0.68||||||||0.68|-2.51|
91490424|NCT03281577|182853404|SUPERIORITY||Least Squares Mean Differences|-27.52||||0.0018|TWO_SIDED|95.0|-45.224|-9.813||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-9.813|-45.224|0.0018
91490425|NCT03281577|182853404|SUPERIORITY||Least Squares Mean Differences|-41.76|||<|0.0001|TWO_SIDED|95.0|-59.616|-23.902||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-23.902|-59.616|<.0001
91490426|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|0.72||||0.259|TWO_SIDED|95.0|-0.364|1.795||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.795|-0.364|0.2590
91726603|NCT02187055|183348350|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|1.08|4.18||||||||4.18|1.08|
91490427|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|1.27||||0.028|TWO_SIDED|95.0|0.119|2.418||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||2.418|0.119|0.0280
91695804|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-3.6||||0.6201|TWO_SIDED|90.0|-20.3|14.5|||Chan and Zhang method|||Week 16||14.5|-20.3|0.6201
91695805|NCT03850483|183286487|SUPERIORITY||Risk Difference (RD)|-0.7||||0.4792|TWO_SIDED|90.0|-17.6|17.0|||Chan and Zhang method|||Week 16||17.0|-17.6|0.4792
91695806|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8038|TWO_SIDED|90.0|-0.25|0.79|||MMRM|||Week 1: Mixed-effect model with repeated measures (MMRM) analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.79|-0.25|0.8038
91726604|NCT02187055|183348350|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.4|3.48||||||||3.48|0.40|
91726605|NCT02187055|183348350|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.24|0.86||||||||0.86|-2.24|
91726606|NCT02187055|183348351|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.16|0.5||||||||0.50|0.16|
91726607|NCT02187055|183348351|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|0.05|0.39||||||||0.39|0.05|
91726608|NCT02187055|183348351|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.28|0.06||||||||0.06|-0.28|
91726609|NCT02187055|183348352|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.15|0.51||||||||0.51|0.15|
91726610|NCT02187055|183348352|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.1|0.46||||||||0.46|0.10|
91726611|NCT02187055|183348352|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.23|0.13||||||||0.13|-0.23|
91726612|NCT02187055|183348353|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.21|||||TWO_SIDED|95.0|-4.99|2.56||||||||2.56|-4.99|
91726613|NCT02187055|183348353|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.78|||||TWO_SIDED|95.0|-5.59|2.04||||||||2.04|-5.59|
91726614|NCT02187055|183348353|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.56|||||TWO_SIDED|95.0|-4.53|3.4||||||||3.40|-4.53|
91726615|NCT02187055|183348354|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.4|||||TWO_SIDED|95.0|-7.95|1.15||||||||1.15|-7.95|
91726616|NCT02187055|183348354|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.55|1.43||||||||1.43|-7.55|
91726617|NCT02187055|183348354|SUPERIORITY_OR_OTHER||Difference in remission rate|0.34|||||TWO_SIDED|95.0|-4.45|5.14||||||||5.14|-4.45|
91695807|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8267|TWO_SIDED|90.0|-0.22|0.81|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.81|-0.22|0.8267
91695808|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6039|TWO_SIDED|90.0|-0.43|0.6|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.60|-0.43|0.6039
91695809|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6339|TWO_SIDED|90.0|-0.41|0.62|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-0.41|0.6339
91695810|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.2666|TWO_SIDED|90.0|-0.68|0.31|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.31|-0.68|0.2666
91726618|NCT02187055|183348355|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.67|||||TWO_SIDED|95.0|-8.29|0.94||||||||0.94|-8.29|
91695811|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.2257|TWO_SIDED|90.0|-0.7|0.26|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-0.70|0.2257
91726619|NCT02187055|183348355|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.59|1.48||||||||1.48|-7.59|
91726620|NCT02187055|183348355|SUPERIORITY_OR_OTHER||Difference in remission rate|0.62|||||TWO_SIDED|95.0|-4.24|5.47||||||||5.47|-4.24|
91726621|NCT02187055|183348356|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.55|||||TWO_SIDED|95.0|-6.03|2.93||||||||2.93|-6.03|
91726622|NCT02187055|183348356|SUPERIORITY_OR_OTHER||Difference in remission rate|-2.02|||||TWO_SIDED|95.0|-6.51|2.47||||||||2.47|-6.51|
91695812|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.1306|TWO_SIDED|90.0|-0.81|0.15|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-0.81|0.1306
91695813|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.9704|TWO_SIDED|90.0|0.09|1.31|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.31|0.09|0.9704
91695814|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.38||0.889|TWO_SIDED|90.0|-0.16|1.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.09|-0.16|0.8890
91726623|NCT02187055|183348356|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.47|||||TWO_SIDED|95.0|-5.11|4.18||||||||4.18|-5.11|
91726624|NCT02187055|183348357|SUPERIORITY_OR_OTHER||Difference in remission rate|-9.49|||||TWO_SIDED|95.0|-15.68|-3.3||||||||-3.30|-15.68|
91726625|NCT02187055|183348357|SUPERIORITY_OR_OTHER||Difference in remission rate|-6.89|||||TWO_SIDED|95.0|-12.94|-0.83||||||||-0.83|-12.94|
91726626|NCT02187055|183348357|SUPERIORITY_OR_OTHER||Difference in remission rate|2.61|||||TWO_SIDED|95.0|-3.86|9.07||||||||9.07|-3.86|
91726627|NCT02187055|183348358|SUPERIORITY_OR_OTHER||Difference in response rate|-6.24|||||TWO_SIDED|95.0|-13.32|0.84||||||||0.84|-13.32|
91726628|NCT02187055|183348358|SUPERIORITY_OR_OTHER||Difference in response rate|-3.66|||||TWO_SIDED|95.0|-10.69|3.37||||||||3.37|-10.69|
91726629|NCT02187055|183348358|SUPERIORITY_OR_OTHER||Difference in response rate|2.58|||||TWO_SIDED|95.0|-4.51|9.68||||||||9.68|-4.51|
91726630|NCT02187055|183348359|SUPERIORITY_OR_OTHER||Difference in response rate|-6.22|||||TWO_SIDED|95.0|-13.29|0.85||||||||0.85|-13.29|
91726631|NCT02187055|183348359|SUPERIORITY_OR_OTHER||Difference in response rate|-3.93|||||TWO_SIDED|95.0|-10.94|3.09||||||||3.09|-10.94|
91726632|NCT02187055|183348359|SUPERIORITY_OR_OTHER||Difference in response rate|2.3|||||TWO_SIDED|95.0|-4.79|9.39||||||||9.39|-4.79|
91726633|NCT02187055|183348360|SUPERIORITY_OR_OTHER||Difference in response rate|-6.02|||||TWO_SIDED|95.0|-12.05|0.0||||||||0.00|-12.05|
91726634|NCT02187055|183348360|SUPERIORITY_OR_OTHER||Difference in response rate|-6.89|||||TWO_SIDED|95.0|-12.9|-0.87||||||||-0.87|-12.90|
91726635|NCT02187055|183348360|SUPERIORITY_OR_OTHER||Difference in response rate|-0.87|||||TWO_SIDED|95.0|-7.17|5.44||||||||5.44|-7.17|
91726636|NCT02187055|183348361|SUPERIORITY_OR_OTHER||Difference in response rate|-4.87|||||TWO_SIDED|95.0|-11.92|2.18||||||||2.18|-11.92|
91726637|NCT02187055|183348361|SUPERIORITY_OR_OTHER||Difference in response rate|-5.48|||||TWO_SIDED|95.0|-12.49|1.52||||||||1.52|-12.49|
91726638|NCT02187055|183348361|SUPERIORITY_OR_OTHER||Difference in rresponse rate|-0.61|||||TWO_SIDED|95.0|-7.7|6.47||||||||6.47|-7.70|
91726639|NCT02187055|183348362|SUPERIORITY_OR_OTHER||Difference in response rate|-8.29|||||TWO_SIDED|95.0|-14.84|-1.75||||||||-1.75|-14.84|
91726640|NCT02187055|183348362|SUPERIORITY_OR_OTHER||Difference in response rate|-6.14|||||TWO_SIDED|95.0|-12.72|0.44||||||||0.44|-12.72|
91726641|NCT02187055|183348362|SUPERIORITY_OR_OTHER||Difference in response rate|2.15|||||TWO_SIDED|95.0|-4.22|8.52||||||||8.52|-4.22|
91726642|NCT02187055|183348363|SUPERIORITY_OR_OTHER||Difference in response rate|-6.77|||||TWO_SIDED|95.0|-12.61|-0.93||||||||-0.93|-12.61|
91726643|NCT02187055|183348363|SUPERIORITY_OR_OTHER||Difference in response rate|-2.5|||||TWO_SIDED|95.0|-8.09|3.1||||||||3.10|-8.09|
91726644|NCT02187055|183348363|SUPERIORITY_OR_OTHER||Difference in response rate|4.27|||||TWO_SIDED|95.0|-1.68|10.23||||||||10.23|-1.68|
91726645|NCT02187055|183348364|SUPERIORITY_OR_OTHER||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.011|0.148||||||||0.148|-0.011|
91726646|NCT02187055|183348364|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.054|0.105||||||||0.105|-0.054|
91726647|NCT02187055|183348364|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|||||TWO_SIDED|95.0|-0.122|0.037||||||||0.037|-0.122|
91726648|NCT02187055|183348365|SUPERIORITY_OR_OTHER||Difference in response rate|-4.07|||||TWO_SIDED|95.0|-10.68|2.55||||||||2.55|-10.68|
91726649|NCT02187055|183348365|SUPERIORITY_OR_OTHER||Difference in response rate|-1.21|||||TWO_SIDED|95.0|-7.87|5.44||||||||5.44|-7.87|
91726650|NCT02187055|183348365|SUPERIORITY_OR_OTHER||Difference in response rate|2.86|||||TWO_SIDED|95.0|-3.72|9.43||||||||9.43|-3.72|
91726651|NCT02187055|183348366|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.28|-0.11||||||||-0.11|-2.28|
91726652|NCT02187055|183348366|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.16|0.01||||||||0.01|-2.16|
91726653|NCT02187055|183348366|SUPERIORITY_OR_OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.97|1.2||||||||1.20|-0.97|
91535594|NCT00991276|182949767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.18|-0.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.47|-1.18|<0.0001
91726654|NCT02187055|183348367|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.74|0.85||||||||0.85|-1.74|
91726655|NCT02187055|183348367|SUPERIORITY_OR_OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.48|2.11||||||||2.11|-0.48|
91726656|NCT02187055|183348367|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||||TWO_SIDED|95.0|-0.04|2.56||||||||2.56|-0.04|
91726657|NCT02187055|183348368|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.22|0.39||||||||0.39|-2.22|
91726658|NCT02187055|183348368|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.19|0.42||||||||0.42|-2.19|
91726659|NCT02187055|183348368|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.27|1.34||||||||1.34|-1.27|
91726660|NCT02187055|183348369|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.52|0.87||||||||0.87|-1.52|
91726661|NCT02187055|183348369|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.8|1.58||||||||1.58|-0.80|
91726662|NCT02187055|183348369|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.47|1.91||||||||1.91|-0.47|
91726663|NCT02187055|183348370|SUPERIORITY_OR_OTHER||LS mean difference|-2.0|||||TWO_SIDED|95.0|-3.25|-0.8||||||||-0.80|-3.25|
91726664|NCT02187055|183348370|SUPERIORITY_OR_OTHER||LS mean difference|-1.7|||||TWO_SIDED|95.0|-2.91|-0.47||||||||-0.47|-2.91|
91726665|NCT02187055|183348370|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.89|1.55||||||||1.55|-0.89|
91726666|NCT02187055|183348371|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.27|-0.05||||||||-0.05|-2.27|
91726667|NCT02187055|183348371|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.4|0.82||||||||0.82|-1.40|
91726668|NCT02187055|183348371|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-0.25|1.98||||||||1.98|-0.25|
91726669|NCT02187055|183348372|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|||||TWO_SIDED|95.0|-1.71|0.68||||||||0.68|-1.71|
91726670|NCT02187055|183348372|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.33|1.05||||||||1.05|-1.33|
91726671|NCT02187055|183348372|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.83|1.57||||||||1.57|-0.83|
91726672|NCT02187055|183348373|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.2|0.45||||||||0.45|-2.20|
91726673|NCT02187055|183348373|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.13|1.51||||||||1.51|-1.13|
91726674|NCT02187055|183348373|SUPERIORITY_OR_OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.26|2.39||||||||2.39|-0.26|
91726675|NCT02187055|183348374|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.54|0.39||||||||0.39|-2.54|
91726676|NCT02187055|183348374|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.76|2.16||||||||2.16|-0.76|
91726677|NCT02187055|183348374|SUPERIORITY_OR_OTHER||LS mean difference|1.8|||||TWO_SIDED|95.0|0.3|3.24||||||||3.24|0.30|
91726678|NCT02187055|183348375|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.55|1.08||||||||1.08|-1.55|
91726679|NCT02187055|183348375|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-1.01|1.62||||||||1.62|-1.01|
91726680|NCT02187055|183348375|SUPERIORITY_OR_OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.78|1.86||||||||1.86|-0.78|
91726681|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-2.279|1.427||||||Work hours missed due to problems||1.427|-2.279|
91726682|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|||||TWO_SIDED|95.0|-2.783|1.044||||||Work hours missed due to problems||1.044|-2.783|
91726683|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||||TWO_SIDED|95.0|-2.349|1.462||||||Work hours missed due to problems||1.462|-2.349|
91726684|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|||||TWO_SIDED|95.0|-2.928|2.346||||||Work hours missed other reason||2.346|-2.928|
91726685|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-1.832|3.64||||||Work hours missed other reason||3.640|-1.832|
91726686|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|-1.52|3.911||||||Work hours missed other reason||3.911|-1.520|
91726687|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|4.95|||||TWO_SIDED|95.0|0.52|9.37||||||Hours worked in past 7 days||9.370|0.520|
91726688|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|2.85|||||TWO_SIDED|90.0|-1.736|7.43||||||Hours worked in past 7 days||7.430|-1.736|
91695815|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.4506|TWO_SIDED|90.0|-0.66|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.66|0.4506
91695816|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.584|TWO_SIDED|90.0|-0.53|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.53|0.5840
91726689|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-2.1|||||TWO_SIDED|95.0|-6.65|2.454||||||Hours worked in past 7 days||2.454|-6.650|
91726690|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.373|0.786||||||Problems affecting productivity||0.786|-0.373|
91695817|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.0769|TWO_SIDED|90.0|-1.17|0.08|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.17|0.0769
91726691|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.578|0.607||||||Problems affecting productivity||0.607|-0.578|
91695818|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.0242|TWO_SIDED|90.0|-1.39|-0.13|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-1.39|0.0242
91695819|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.38||0.0127|TWO_SIDED|90.0|-1.49|-0.23|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.23|-1.49|0.0127
91726692|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.19|||||TWO_SIDED|95.0|-0.784|0.4||||||Problems affecting productivity||0.400|-0.784|
91726693|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.24|||||TWO_SIDED|95.0|-0.112|0.587||||||Problem affecting daily activities||0.587|-0.112|
91726694|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.341|0.357||||||Problem affecting daily activities||0.357|-0.341|
91726695|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|||||TWO_SIDED|95.0|-0.582|0.122||||||Problem affecting daily activities||0.122|-0.582|
91726696|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-5.748|3.553||||||% work time missed due to health||3.553|-5.748|
91726697|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-2.64|||||TWO_SIDED|95.0|-7.339|2.067||||||% work time missed due to health||2.067|-7.339|
91726698|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-1.54|||||TWO_SIDED|95.0|-6.283|3.207||||||% work time missed due to health||3.207|-6.283|
91726699|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||||TWO_SIDED|95.0|-3.726|7.858||||||% impairment while working due to health||7.858|-3.726|
91726700|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.15|||||TWO_SIDED|95.0|-5.777|6.068||||||% impairment while working due to health||6.068|-5.777|
91726701|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-7.839|3.998||||||% impairment while working due to health||3.998|-7.839|
91726702|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|2.11|||||TWO_SIDED|95.0|-4.664|8.877||||||% overall work impairment due to health||8.877|-4.664|
91726703|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|95.0|-5.164|8.58||||||% overall work impairment due to health||8.580|-5.164|
91726704|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-7.307|6.51||||||% overall work impairment due to health||6.510|-7.307|
91695820|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.44||0.6693|TWO_SIDED|90.0|-0.54|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-0.54|0.6693
91726705|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||||TWO_SIDED|95.0|-1.118|5.873||||||% activity impairment due to health||5.873|-1.118|
91726706|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|0.08|||||TWO_SIDED|95.0|-3.411|3.573||||||% activity impairment due to health||3.573|-3.411|
91726707|NCT02187055|183348376|SUPERIORITY_OR_OTHER||LS mean difference|-2.3|||||TWO_SIDED|95.0|-5.818|1.225||||||% activity impairment due to health||1.225|-5.818|
91726708|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.057|0.011||||||Utility score||0.011|-0.057|
91695821|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6742|TWO_SIDED|90.0|-0.55|0.96|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.96|-0.55|0.6742
91695822|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4486|TWO_SIDED|90.0|-0.79|0.67|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.79|0.4486
91695823|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3219|TWO_SIDED|90.0|-0.93|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.93|0.3219
91726709|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.054|0.013||||||Utility score||0.013|-0.054|
91695824|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.55||0.0096|TWO_SIDED|90.0|-2.21|-0.39|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.39|-2.21|0.0096
91726710|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.031|0.036||||||Utility score||0.036|-0.031|
91726711|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|||||TWO_SIDED|95.0|-0.098|0.042||||||Mobility score||0.042|-0.098|
91726712|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.079|0.06||||||Mobility score||0.060|-0.079|
91726713|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.02|||||TWO_SIDED|95.0|-0.051|0.089||||||Mobility score||0.089|-0.051|
91726714|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.014|0.127||||||Self-care score||0.127|-0.014|
91726715|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.027|0.114||||||Self-care score||0.114|-0.027|
91726716|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.083|0.058||||||Self-care score||0.058|-0.083|
91726717|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.062|0.084||||||Usual activities score||0.084|-0.062|
91726718|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.018|0.129||||||Usual activities score||0.129|-0.018|
91726719|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.029|0.118||||||Usual activities score||0.118|-0.029|
91726720|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
91726721|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.015|0.116||||||Pain/discomfort score||0.116|-0.015|
91695825|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.0862|TWO_SIDED|90.0|-1.64|0.15|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.64|0.0862
91695826|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54||0.0111|TWO_SIDED|90.0|-2.15|-0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.36|-2.15|0.0111
91695827|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.6107|TWO_SIDED|90.0|-0.68|0.97|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.97|-0.68|0.6107
91695828|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.724|TWO_SIDED|90.0|-0.54|1.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.15|-0.54|0.7240
91695829|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|90.0|-0.91|0.74|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.91|0.4300
91695830|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.0501|TWO_SIDED|90.0|-1.66|0.0|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.66|0.0501
91695831|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58||0.0157|TWO_SIDED|90.0|-2.23|-0.3|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.30|-2.23|0.0157
91695832|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0645|TWO_SIDED|90.0|-1.83|0.07|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.83|0.0645
91695833|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0621|TWO_SIDED|90.0|-1.84|0.06|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.06|-1.84|0.0621
91695834|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.2959|TWO_SIDED|90.0|-1.21|0.62|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-1.21|0.2959
91695835|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.57||0.9043|TWO_SIDED|90.0|-0.19|1.69|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.69|-0.19|0.9043
91695836|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.2014|TWO_SIDED|90.0|-1.38|0.45|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.45|-1.38|0.2014
91695837|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.0948|TWO_SIDED|90.0|-1.66|0.19|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.19|-1.66|0.0948
91695838|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.65||0.0416|TWO_SIDED|90.0|-2.21|-0.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.06|-2.21|0.0416
91695839|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.64||0.0454|TWO_SIDED|90.0|-2.14|-0.03|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.03|-2.14|0.0454
91695840|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.64||0.0256|TWO_SIDED|90.0|-2.31|-0.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.20|-2.31|0.0256
91695841|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.2326|TWO_SIDED|90.0|-1.36|0.53|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.36|0.2326
91695842|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.5141|TWO_SIDED|90.0|-0.95|0.99|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.99|-0.95|0.5141
91695843|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.1124|TWO_SIDED|90.0|-1.64|0.25|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.25|-1.64|0.1124
91695844|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.0983|TWO_SIDED|90.0|-1.7|0.21|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.70|0.0983
91695845|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.0412|TWO_SIDED|90.0|-2.46|-0.07|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.07|-2.46|0.0412
91490428|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|0.45||||0.6882|TWO_SIDED|95.0|-0.757|1.66||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.660|-0.757|0.6882
91695846|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.034|TWO_SIDED|90.0|-2.47|-0.13|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-2.47|0.0340
91695847|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.0379|TWO_SIDED|90.0|-2.44|-0.09|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.44|0.0379
91695848|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.68||0.1291|TWO_SIDED|90.0|-1.91|0.36|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.36|-1.91|0.1291
91695849|NCT03850483|183286488|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.5776|TWO_SIDED|90.0|-1.03|1.3|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.30|-1.03|0.5776
91695850|NCT03850483|183286488|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1044|TWO_SIDED|90.0|-2.0|0.27|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.27|-2.00|0.1044
91695851|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.0608|TWO_SIDED|90.0|-2.23|0.07|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-2.23|0.0608
91695852|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0309|TWO_SIDED|90.0|-2.84|-0.18|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.18|-2.84|0.0309
91695853|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0242|TWO_SIDED|90.0|-2.85|-0.26|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.26|-2.85|0.0242
91695854|NCT03850483|183286488|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.78||0.0394|TWO_SIDED|90.0|-2.69|-0.09|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.69|0.0394
91695855|NCT03850483|183286490|SUPERIORITY||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|5.09||0.6917|TWO_SIDED|90.0|-5.86|10.97|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.97|-5.86|0.6917
91695856|NCT03850483|183286490|SUPERIORITY||LS mean difference|7.3|STANDARD_ERROR_OF_MEAN|5.07||0.9241|TWO_SIDED|90.0|-1.09|15.69|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.69|-1.09|0.9241
91695857|NCT03850483|183286490|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|5.03||0.8443|TWO_SIDED|90.0|-3.21|13.42|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.42|-3.21|0.8443
91695858|NCT03850483|183286490|SUPERIORITY||LS mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.04||0.6911|TWO_SIDED|90.0|-5.82|10.86|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.86|-5.82|0.6911
91695859|NCT03850483|183286490|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|4.79||0.3676|TWO_SIDED|90.0|-9.56|6.31|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.31|-9.56|0.3676
91695860|NCT03850483|183286490|SUPERIORITY||LS mean difference|-6.3|STANDARD_ERROR_OF_MEAN|4.72||0.0915|TWO_SIDED|90.0|-14.13|1.5|||MMRM|||Week 1: Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.50|-14.13|0.0915
91695861|NCT03850483|183286490|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.72||0.097|TWO_SIDED|90.0|-13.96|1.65|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.65|-13.96|0.0970
91695862|NCT03850483|183286490|SUPERIORITY||LS mean difference|9.2|STANDARD_ERROR_OF_MEAN|5.91||0.9389|TWO_SIDED|90.0|-0.59|18.97|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||18.97|-0.59|0.9389
91726722|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
91726723|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.046|0.103||||||Anxiety/depression score||0.103|-0.046|
91726724|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.066|0.083||||||Anxiety/depression score||0.083|-0.066|
91695863|NCT03850483|183286490|SUPERIORITY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|6.07||0.9295|TWO_SIDED|90.0|-1.06|19.02|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors||19.02|-1.06|0.9295
91695864|NCT03850483|183286490|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.92||0.7308|TWO_SIDED|90.0|-6.15|13.45|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.45|-6.15|0.7308
91695865|NCT03850483|183286490|SUPERIORITY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|5.94||0.6199|TWO_SIDED|90.0|-8.01|11.64|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||11.64|-8.01|0.6199
91695866|NCT03850483|183286490|SUPERIORITY||LS mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.09||0.0699|TWO_SIDED|90.0|-19.13|1.04|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.04|-19.13|0.0699
91695867|NCT03850483|183286490|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|6.14||0.03|TWO_SIDED|90.0|-21.79|-1.48|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.48|-21.79|0.0300
91695868|NCT03850483|183286490|SUPERIORITY||LS mean difference|-13.1|STANDARD_ERROR_OF_MEAN|6.09||0.0168|TWO_SIDED|90.0|-23.15|-2.98|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.98|-23.15|0.0168
91695869|NCT03850483|183286490|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|6.61||0.7083|TWO_SIDED|90.0|-7.3|14.57|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.57|-7.30|0.7083
91695870|NCT03850483|183286490|SUPERIORITY||LS mean difference|8.5|STANDARD_ERROR_OF_MEAN|6.77||0.8955|TWO_SIDED|90.0|-2.66|19.75|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.75|-2.66|0.8955
91695871|NCT03850483|183286490|SUPERIORITY||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.56||0.8386|TWO_SIDED|90.0|-4.35|17.37|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.37|-4.35|0.8386
91695872|NCT03850483|183286490|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|6.58||0.4371|TWO_SIDED|90.0|-11.93|9.84|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.84|-11.93|0.4371
91695873|NCT03850483|183286490|SUPERIORITY||LS mean difference|-20.7|STANDARD_ERROR_OF_MEAN|8.91||0.0108|TWO_SIDED|90.0|-35.42|-5.92|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-5.92|-35.42|0.0108
91695874|NCT03850483|183286490|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|8.75||0.1066|TWO_SIDED|90.0|-25.43|3.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.55|-25.43|0.1066
91695875|NCT03850483|183286490|SUPERIORITY||LS mean difference|-16.0|STANDARD_ERROR_OF_MEAN|8.76||0.0344|TWO_SIDED|90.0|-30.54|-1.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.55|-30.54|0.0344
91695876|NCT03850483|183286490|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|8.29||0.6594|TWO_SIDED|90.0|-10.3|17.13|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.13|-10.30|0.6594
91695877|NCT03850483|183286490|SUPERIORITY||LS mean difference|5.3|STANDARD_ERROR_OF_MEAN|8.52||0.7307|TWO_SIDED|90.0|-8.85|19.36|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.36|-8.85|0.7307
91726725|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.094|0.055||||||Anxiety/depression score||0.055|-0.094|
91726726|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||||TWO_SIDED|95.0|-2.934|2.648||||||VAS score||2.648|-2.934|
91695878|NCT03850483|183286490|SUPERIORITY||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|8.28||0.5914|TWO_SIDED|90.0|-11.78|15.61|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.61|-11.78|0.5914
91695879|NCT03850483|183286490|SUPERIORITY||LS mean difference|-12.3|STANDARD_ERROR_OF_MEAN|8.34||0.0709|TWO_SIDED|90.0|-26.13|1.49|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.49|-26.13|0.0709
91726727|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|1.23|||||TWO_SIDED|95.0|-1.556|4.016||||||VAS score||4.016|-1.556|
91726728|NCT02187055|183348377|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.425|4.171||||||VAS score||4.171|-1.425|
91726729|NCT02187055|183348378|SUPERIORITY_OR_OTHER||LS mean difference|-0.45|||||TWO_SIDED|95.0|-1.706|0.808||||||||0.808|-1.706|
91726730|NCT02187055|183348378|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.178|2.325||||||||2.325|-0.178|
91726731|NCT02187055|183348378|SUPERIORITY_OR_OTHER||LS mean difference|1.52|||||TWO_SIDED|95.0|0.266|2.779||||||||2.779|0.266|
91726732|NCT00441896|183348400|SUPERIORITY|||||||0.7391|||||||ANCOVA|||||||0.7391
91726733|NCT00441896|183348400|SUPERIORITY|||||||0.537|||||||ANCOVA|||||||0.5370
91726734|NCT00441896|183348400|SUPERIORITY|||||||0.908|||||||ANCOVA|||||||0.9080
91695880|NCT03850483|183286490|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|9.53||0.0253|TWO_SIDED|90.0|-34.55|-3.01|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.01|-34.55|0.0253
91490429|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|1.87||||0.0062|TWO_SIDED|95.0|0.493|3.25||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||3.250|0.493|0.0062
91695881|NCT03850483|183286490|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|9.38||0.078|TWO_SIDED|90.0|-28.89|2.15|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.15|-28.89|0.0780
91695882|NCT03850483|183286490|SUPERIORITY||LS mean difference|-9.7|STANDARD_ERROR_OF_MEAN|9.36||0.1516|TWO_SIDED|90.0|-25.17|5.83|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.83|-25.17|0.1516
91695883|NCT03850483|183286490|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|9.14||0.4861|TWO_SIDED|90.0|-15.45|14.81|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.81|-15.45|0.4861
91695884|NCT03850483|183286490|SUPERIORITY||LS mean difference|11.0|STANDARD_ERROR_OF_MEAN|9.38||0.8795|TWO_SIDED|90.0|-4.48|26.55|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||26.55|-4.48|0.8795
91695885|NCT03850483|183286490|SUPERIORITY||LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|9.11||0.2867|TWO_SIDED|90.0|-20.22|9.94|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.94|-20.22|0.2867
91695886|NCT03850483|183286490|SUPERIORITY||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|9.23||0.1267|TWO_SIDED|90.0|-25.86|4.69|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||4.69|-25.86|0.1267
91695887|NCT03850483|183286490|SUPERIORITY||LS mean difference|-17.1|STANDARD_ERROR_OF_MEAN|10.49||0.0526|TWO_SIDED|90.0|-34.48|0.26|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-34.48|0.0526
91695888|NCT03850483|183286490|SUPERIORITY||LS mean difference|-14.3|STANDARD_ERROR_OF_MEAN|10.25||0.0827|TWO_SIDED|90.0|-31.26|2.68|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.68|-31.26|0.0827
91695889|NCT03850483|183286490|SUPERIORITY||LS mean difference|-16.1|STANDARD_ERROR_OF_MEAN|10.26||0.0592|TWO_SIDED|90.0|-33.12|0.86|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-33.12|0.0592
91695890|NCT03850483|183286490|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.03||0.4657|TWO_SIDED|90.0|-15.72|14.16|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.16|-15.72|0.4657
91695891|NCT03850483|183286490|SUPERIORITY||LS mean difference|3.9|STANDARD_ERROR_OF_MEAN|9.3||0.6612|TWO_SIDED|90.0|-11.52|19.26|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.26|-11.52|0.6612
91695892|NCT03850483|183286490|SUPERIORITY||LS mean difference|-8.5|STANDARD_ERROR_OF_MEAN|9.03||0.1749|TWO_SIDED|90.0|-23.42|6.48|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.48|-23.42|0.1749
91695893|NCT03850483|183286490|SUPERIORITY||LS mean difference|-9.3|STANDARD_ERROR_OF_MEAN|9.12||0.1548|TWO_SIDED|90.0|-24.39|5.8|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.80|-24.39|0.1548
91695894|NCT03850483|183286490|SUPERIORITY||LS mean difference|-21.0|STANDARD_ERROR_OF_MEAN|11.89||0.04|TWO_SIDED|90.0|-40.67|-1.28|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.28|-40.67|0.0400
91695895|NCT03850483|183286490|SUPERIORITY||LS mean difference|-22.6|STANDARD_ERROR_OF_MEAN|11.6||0.0267|TWO_SIDED|90.0|-41.82|-3.39|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.39|-41.82|0.0267
91695896|NCT03850483|183286490|SUPERIORITY||LS mean difference|-22.2|STANDARD_ERROR_OF_MEAN|11.63||0.0295|TWO_SIDED|90.0|-41.42|-2.89|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.89|-41.42|0.0295
91695897|NCT03850483|183286490|SUPERIORITY||LS mean difference|-9.1|STANDARD_ERROR_OF_MEAN|10.38||0.1903|TWO_SIDED|90.0|-26.3|8.05|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||8.05|-26.30|0.1903
91695898|NCT03850483|183286490|SUPERIORITY||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|10.65||0.553|TWO_SIDED|90.0|-16.21|19.06|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.06|-16.21|0.5530
91726735|NCT00441896|183348400|SUPERIORITY|||||||0.2539|||||||ANCOVA|||||||0.2539
91726736|NCT00441896|183348400|SUPERIORITY|||||||0.6657|||||||ANCOVA|||||||0.6657
91695899|NCT03850483|183286490|SUPERIORITY||LS mean difference|-13.8|STANDARD_ERROR_OF_MEAN|10.37||0.0933|TWO_SIDED|90.0|-30.92|3.4|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.40|-30.92|0.0933
91695900|NCT03850483|183286490|SUPERIORITY||LS mean difference|-19.0|STANDARD_ERROR_OF_MEAN|10.49||0.036|TWO_SIDED|90.0|-36.37|-1.65|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.65|-36.37|0.0360
91695901|NCT03850483|183286490|SUPERIORITY||LS mean difference|-24.5|STANDARD_ERROR_OF_MEAN|13.46||0.0354|TWO_SIDED|90.0|-46.85|-2.23|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.23|-46.85|0.0354
91695902|NCT03850483|183286490|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|13.07||0.0239|TWO_SIDED|90.0|-47.77|-4.46|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-4.46|-47.77|0.0239
91695903|NCT03850483|183286490|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|13.11||0.0342|TWO_SIDED|90.0|-45.84|-2.38|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.38|-45.84|0.0342
91695904|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3279|TWO_SIDED|90.0|-0.91|0.52|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.91|0.3279
91695905|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3566|TWO_SIDED|90.0|-0.88|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.88|0.3566
91695906|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.1165|TWO_SIDED|90.0|-1.29|0.21|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.29|0.1165
91726737|NCT00441896|183348401|SUPERIORITY|||||||0.4249|||||||ANCOVA|||||||0.4249
91726738|NCT00441896|183348401|SUPERIORITY|||||||0.4177|||||||ANCOVA|||||||0.4177
91726739|NCT00441896|183348401|SUPERIORITY|||||||0.3033|||||||ANCOVA|||||||0.3033
91726740|NCT00441896|183348401|SUPERIORITY|||||||0.3014|||||||ANCOVA|||||||0.3014
91726741|NCT00441896|183348401|SUPERIORITY|||||||0.1839|||||||ANCOVA|||||||0.1839
91726742|NCT01301092|183348409|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.443|||||TWO_SIDED|90.0|0.395|0.497|||Mixed Linear effects model analyses|||||0.497|0.395|
91726743|NCT01301092|183348410|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.1|||||TWO_SIDED|90.0|1.84|2.41|||Mixed Linear effects model analyses|||||2.41|1.84|
91726744|NCT01301092|183348411|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.962|||||TWO_SIDED|90.0|0.858|1.08|||Mixed Linear effects model analyses|||||1.08|0.858|
91726745|NCT01301092|183348412|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.924|1.19|||Mixed Linear effects model analyses|||||1.19|0.924|
91726746|NCT03277274|183348421|OTHER|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.579|||||||ANOVA|||||||0.579
91726747|NCT03277274|183348421|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.026|||||||ANOVA|||||||0.026
91726748|NCT03277274|183348421|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.02|||||||ANOVA|||||||0.020
91726749|NCT03277274|183348421|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.031|||||||ANOVA|||||||0.031
91726750|NCT03277274|183348422|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.151|||||||ANOVA|||||||0.151
91726751|NCT03277274|183348422|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.017|||||||ANOVA|||||||0.017
91726752|NCT03277274|183348422|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.129|||||||ANOVA|||||||0.129
91726753|NCT03277274|183348422|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
91726754|NCT03277274|183348423|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.138|||||||ANOVA|||||||0.138
91726755|NCT03277274|183348423|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.029|||||||ANOVA|||||||0.029
91726756|NCT03277274|183348423|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.201|||||||ANOVA|||||||0.201
91726757|NCT03277274|183348423|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
91726758|NCT01793129|183348439|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that id does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.74|2.0|||||The relative risk estimate was calculated by dividing risk under hypothermia by risk under normothermia.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|To get estimates of RR from the Bayesian logistic regression model, predicted probabilities of the outcome were generated for all infants assuming the infants were treated with and without hypothermia and with/without severe encephalopathy. Next subject level RR values were estimated for all infants and 2.5, 50, and 97.5 percentiles were calculated.|2.00|0.74|
91726759|NCT03548415|183348474|SUPERIORITY|||||||0.306||||||The p-value was analyzed using the nonparametric test, Van Elteren test with IGF-1 level as stratification factor.|Van Elteren test|||||||0.306
91726760|NCT01230814|183348485|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.69|TWO_SIDED|95.0|0.62|1.37||The a priori threshold for statistical significance for VVC was p\<0.020 (two-sided).|Clustered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of positive test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which VVC was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||1.37|0.62|0.690
91726761|NCT01230814|183348486|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.005|TWO_SIDED|95.0|0.48|0.87||The a priori threshold for statistical significance for BV was p\<0.030 (two-sided).|clutstered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which BV was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||0.87|0.48|0.005
91726762|NCT00676052|183348509|SUPERIORITY||Mean Difference (Net)|0.067||||0.009|TWO_SIDED|95.0|0.017|0.117||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.117|0.017|0.009
91726763|NCT00676052|183348509|SUPERIORITY||Mean Difference (Net)|0.097|||<|0.001|TWO_SIDED|95.0|0.047|0.147||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.147|0.047|<0.001
91726764|NCT00676052|183348509|SUPERIORITY||Mean Difference (Net)|0.069||||0.007|TWO_SIDED|95.0|0.019|0.118||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.118|0.019|0.007
91726765|NCT00676052|183348509|SUPERIORITY||Mean Difference (Net)|0.082||||0.001|TWO_SIDED|95.0|0.032|0.132||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.132|0.032|0.001
91695907|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3633|TWO_SIDED|90.0|-0.85|0.55|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.55|-0.85|0.3633
91695908|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.3766|TWO_SIDED|90.0|-0.83|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.83|0.3766
91695909|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1179|TWO_SIDED|90.0|-1.22|0.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.20|-1.22|0.1179
91695910|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.8647|TWO_SIDED|90.0|-0.24|1.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.20|-0.24|0.8647
91695911|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3294|TWO_SIDED|90.0|-0.9|0.52|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.90|0.3294
91695912|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.44||0.1231|TWO_SIDED|90.0|-1.23|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.23|0.1231
91695913|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0878|TWO_SIDED|90.0|-1.37|0.13|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.13|-1.37|0.0878
91695914|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1225|TWO_SIDED|90.0|-1.2|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.20|0.1225
91695915|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3663|TWO_SIDED|90.0|-0.85|0.56|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.85|0.3663
91695916|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0929|TWO_SIDED|90.0|-1.27|0.14|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.27|0.0929
91695917|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3111|TWO_SIDED|90.0|-0.95|0.51|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-0.95|0.3111
91695918|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.4745|TWO_SIDED|90.0|-0.74|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.69|-0.74|0.4745
91695919|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2409|TWO_SIDED|90.0|-1.03|0.42|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.03|0.2409
91695920|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.2018|TWO_SIDED|90.0|-1.13|0.37|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.13|0.2018
91695921|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3925|TWO_SIDED|90.0|-0.83|0.59|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.59|-0.83|0.3925
91695922|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.42||0.5348|TWO_SIDED|90.0|-0.66|0.73|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.73|-0.66|0.5348
91695923|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0739|TWO_SIDED|90.0|-1.33|0.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.09|-1.33|0.0739
91726766|NCT00676052|183348509|SUPERIORITY||Mean Difference (Net)|0.137|||<|0.001|TWO_SIDED|95.0|0.086|0.187||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.187|0.086|<0.001
91726767|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.065|0.146||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.146|0.065|<0.001
91726768|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.107|||<|0.001|TWO_SIDED|95.0|0.067|0.147||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.147|0.067|<0.001
91726769|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.123|||<|0.001|TWO_SIDED|95.0|0.083|0.163||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.163|0.083|<0.001
91726770|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.152|||<|0.001|TWO_SIDED|95.0|0.112|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.193|0.112|<0.001
91695924|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4014|TWO_SIDED|90.0|-0.84|0.62|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.62|-0.84|0.4014
91695925|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6588|TWO_SIDED|90.0|-0.56|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.93|-0.56|0.6588
91695926|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.2997|TWO_SIDED|90.0|-1.0|0.52|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-1.00|0.2997
91695927|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2518|TWO_SIDED|90.0|-1.08|0.46|||MMRM|||Week 4:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.46|-1.08|0.2518
91695928|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2634|TWO_SIDED|90.0|-1.0|0.45|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.00|0.2634
91726771|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.135|0.216||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.216|0.135|<0.001
91726772|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.056|0.157||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.157|0.056|<0.001
91726773|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.192||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV, Day 28||0.192|0.092|<0.001
91726774|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.124|||<|0.001|TWO_SIDED|95.0|0.074|0.174||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.174|0.074|<0.001
91726775|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.193|0.092|<0.001
91726776|NCT00676052|183348510|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.12|0.22||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.220|0.120|<0.001
91726777|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.166|||<|0.001|TWO_SIDED|95.0|0.094|0.237||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.237|0.094|<0.001
91695929|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.1999|TWO_SIDED|90.0|-1.11|0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.36|-1.11|0.1999
91695930|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.44||0.1847|TWO_SIDED|90.0|-1.13|0.33|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.33|-1.13|0.1847
91695931|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4569|TWO_SIDED|90.0|-0.81|0.71|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.71|-0.81|0.4569
91695932|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8536|TWO_SIDED|90.0|-0.27|1.22|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.22|-0.27|0.8536
91695933|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4812|TWO_SIDED|90.0|-0.79|0.74|||MMRM|||Week 6:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.74|-0.79|0.4812
91695934|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.2276|TWO_SIDED|90.0|-1.13|0.42|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.13|0.2276
91726778|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.186|||<|0.001|TWO_SIDED|95.0|0.115|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.258|0.115|<0.001
91695935|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0895|TWO_SIDED|90.0|-1.34|0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.34|0.0895
91726779|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.198|||<|0.001|TWO_SIDED|95.0|0.127|0.268||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.268|0.127|<0.001
91695936|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.47||0.0411|TWO_SIDED|90.0|-1.58|-0.04|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.04|-1.58|0.0411
91695937|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.47||0.0928|TWO_SIDED|90.0|-1.4|0.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.15|-1.40|0.0928
91695938|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.0799|TWO_SIDED|90.0|-1.48|0.12|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.12|-1.48|0.0799
91726780|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.244|||<|0.001|TWO_SIDED|95.0|0.172|0.315||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.315|0.172|<0.001
91726781|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.301|||<|0.001|TWO_SIDED|95.0|0.229|0.372||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.372|0.229|<0.001
91726782|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.178|||<|0.001|TWO_SIDED|95.0|0.098|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.258|0.098|<0.001
91726783|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.219|||<|0.001|TWO_SIDED|95.0|0.139|0.298||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.298|0.139|<0.001
91726784|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.191|||<|0.001|TWO_SIDED|95.0|0.111|0.27||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.270|0.111|<0.001
91726785|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.232|||<|0.001|TWO_SIDED|95.0|0.152|0.312||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.312|0.152|<0.001
91726786|NCT00676052|183348511|SUPERIORITY||Mean Difference (Net)|0.294|||<|0.001|TWO_SIDED|95.0|0.214|0.373||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.373|0.214|<0.001
91726787|NCT00676052|183348512|SUPERIORITY||Mean Difference (Net)|0.099||||0.021|TWO_SIDED|95.0|0.015|0.182||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.182|0.015|0.021
91726788|NCT00676052|183348512|SUPERIORITY||Mean Difference (Net)|0.15|||<|0.001|TWO_SIDED|95.0|0.067|0.233||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.233|0.067|<0.001
91695939|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.46||0.7872|TWO_SIDED|90.0|-0.39|1.11|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.11|-0.39|0.7872
91726789|NCT00676052|183348512|SUPERIORITY||Mean Difference (Net)|0.094||||0.026|TWO_SIDED|95.0|0.011|0.177||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.177|0.011|0.026
91726790|NCT00676052|183348512|SUPERIORITY||Mean Difference (Net)|0.163|||<|0.001|TWO_SIDED|95.0|0.08|0.247||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.247|0.080|<0.001
91726791|NCT00676052|183348512|SUPERIORITY||Mean Difference (Net)|0.235|||<|0.001|TWO_SIDED|95.0|0.152|0.319||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.319|0.152|<0.001
91726792|NCT01243424|183348523|NON_INFERIORITY|This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.|Hazard Ratio (HR)|0.98|||<|0.0001|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test for non-inferiority were calculated.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride||||1.14|0.84|<0.0001
91726793|NCT01243424|183348523|SUPERIORITY|This was the second step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.98||||0.3813|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.84|0.3813
91726794|NCT01243424|183348524|SUPERIORITY|This was the third step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.99||||0.4334|TWO_SIDED|95.47|0.86|1.14||P-values derived from Wald´s Chi-square test for non-inferiority.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.86|0.4334
91726795|NCT01243424|183348525|OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.47|1.43|1.96||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|||1.96|1.43|<0.0001
91726796|NCT01243424|183348526|OTHER||Odds Ratio (OR)|1.29||||0.0004|TWO_SIDED|95.47|1.11|1.48||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.48|1.11|0.0004
91695940|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6294|TWO_SIDED|90.0|-0.61|0.92|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.92|-0.61|0.6294
91695941|NCT03850483|183286492|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.48||0.5174|TWO_SIDED|90.0|-0.76|0.8|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.80|-0.76|0.5174
91535595|NCT00991276|182949767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.31|-0.6||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.60|-1.31|<0.0001
91695942|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3136|TWO_SIDED|90.0|-0.98|0.53|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-0.98|0.3136
91695943|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.102|TWO_SIDED|90.0|-1.42|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.42|0.1020
91695944|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.1923|TWO_SIDED|90.0|-1.2|0.37|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.20|0.1923
91695945|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.0997|TWO_SIDED|90.0|-1.44|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.44|0.0997
91695946|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2497|TWO_SIDED|90.0|-1.08|0.45|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.08|0.2497
91695947|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2568|TWO_SIDED|90.0|-1.08|0.47|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.47|-1.08|0.2568
91695948|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.373|TWO_SIDED|90.0|-0.95|0.64|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.64|-0.95|0.3730
91695949|NCT03850483|183286492|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46||0.0137|TWO_SIDED|90.0|-1.76|-0.26|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.26|-1.76|0.0137
91695950|NCT03850483|183286492|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0055|TWO_SIDED|90.0|-2.06|-0.44|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.44|-2.06|0.0055
91695951|NCT03850483|183286492|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.48||0.0069|TWO_SIDED|90.0|-1.99|-0.4|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.40|-1.99|0.0069
91695952|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.1648|TWO_SIDED|90.0|-1.34|0.34|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.34|-1.34|0.1648
91726797|NCT01243424|183348530|OTHER||Hazard Ratio (HR)|0.96||||0.5249|TWO_SIDED|95.0|0.85|1.09||p-value derived from Wald´s chi-square test.|Regression, Cox||Hazard ratio and confidence interval derived from Cox regression with factor treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.09|0.85|0.5249
91726798|NCT01243424|183348531|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0023|TWO_SIDED|95.0|-0.15|-0.03|||ANCOVA|The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-0.03|-0.15|0.0023
91726799|NCT01243424|183348532|OTHER||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.7|-4.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-4.8|-9.7|<0.0001
91695953|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.2931|TWO_SIDED|90.0|-1.02|0.51|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-1.02|0.2931
91695954|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.47||0.3047|TWO_SIDED|90.0|-1.01|0.53|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-1.01|0.3047
91695955|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.1924|TWO_SIDED|90.0|-1.22|0.38|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.38|-1.22|0.1924
91695956|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0465|TWO_SIDED|90.0|-1.52|-0.02|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.02|-1.52|0.0465
91695957|NCT03850483|183286492|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0048|TWO_SIDED|90.0|-2.08|-0.47|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.47|-2.08|0.0048
91535596|NCT00991276|182949767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4677|TWO_SIDED|95.0|-0.22|0.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.48|-0.22|0.4677
91695958|NCT03850483|183286492|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0186|TWO_SIDED|90.0|-1.78|-0.21|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.21|-1.78|0.0186
91695959|NCT03850483|183286492|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.0675|TWO_SIDED|90.0|-1.61|0.08|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.08|-1.61|0.0675
91695960|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.3232|TWO_SIDED|90.0|-0.69|0.39|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.39|-0.69|0.3232
91695961|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.0736|TWO_SIDED|90.0|-1.03|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.03|0.0736
91695962|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.0743|TWO_SIDED|90.0|-1.07|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.07|0.0743
91695963|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.0641|TWO_SIDED|90.0|-1.03|0.04|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.04|-1.03|0.0641
91695964|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3887|TWO_SIDED|90.0|-0.71|0.5|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.50|-0.71|0.3887
91695965|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.37||0.0767|TWO_SIDED|90.0|-1.15|0.08|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.15|0.0767
91695966|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.2529|TWO_SIDED|90.0|-0.89|0.38|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.38|-0.89|0.2529
91490430|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|1.19||||0.149|TWO_SIDED|95.0|-0.327|2.717||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.717|-0.327|0.1490
91490431|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|0.63||||0.6285|TWO_SIDED|95.0|-0.931|2.2||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.200|-0.931|0.6285
91695967|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5304|TWO_SIDED|90.0|-0.61|0.67|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.61|0.5304
91695968|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.292|TWO_SIDED|90.0|-0.87|0.43|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.43|-0.87|0.2920
91695969|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.2593|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.2593
91695970|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.431|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.4310
91695971|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5477|TWO_SIDED|90.0|-0.59|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.59|0.5477
91695972|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.0696|TWO_SIDED|90.0|-1.24|0.07|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.24|0.0696
91695973|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.3583|TWO_SIDED|90.0|-0.82|0.53|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.82|0.3583
91695974|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6826|TWO_SIDED|90.0|-0.56|1.01|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.01|-0.56|0.6826
91695975|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.457|TWO_SIDED|90.0|-0.84|0.74|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.84|0.4570
91695976|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.3265|TWO_SIDED|90.0|-1.03|0.59|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.59|-1.03|0.3265
91695977|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3039|TWO_SIDED|90.0|-1.0|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.00|0.3039
91695978|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2086|TWO_SIDED|90.0|-1.23|0.42|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.42|-1.23|0.2086
91695979|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2172|TWO_SIDED|90.0|-1.22|0.44|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.44|-1.22|0.2172
91695980|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.2855|TWO_SIDED|90.0|-1.16|0.57|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-1.16|0.2855
91490432|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|1.29||||0.0358|TWO_SIDED|95.0|0.073|2.501||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.501|0.073|0.0358
91490433|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|1.33||||0.043|TWO_SIDED|95.0|0.035|2.621||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.621|0.035|0.0430
91695981|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.8372|TWO_SIDED|90.0|-0.34|1.36|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.36|-0.34|0.8372
91695982|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.52||0.4792|TWO_SIDED|90.0|-0.89|0.84|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.84|-0.89|0.4792
91695983|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3331|TWO_SIDED|90.0|-1.12|0.65|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.65|-1.12|0.3331
91695984|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.108|TWO_SIDED|90.0|-1.47|0.21|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.47|0.1080
91695985|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.48||0.0455|TWO_SIDED|90.0|-1.61|-0.02|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-1.61|0.0455
91695986|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.48||0.0761|TWO_SIDED|90.0|-1.49|0.1|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.10|-1.49|0.0761
91695987|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0273|TWO_SIDED|90.0|-1.8|-0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.14|-1.80|0.0273
91695988|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.54||0.7214|TWO_SIDED|90.0|-0.57|1.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.20|-0.57|0.7214
91695989|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6132|TWO_SIDED|90.0|-0.75|1.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.06|-0.75|0.6132
91695990|NCT03850483|183286494|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.5704|TWO_SIDED|90.0|-0.83|1.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.02|-0.83|0.5704
91695991|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3449|TWO_SIDED|90.0|-1.1|0.67|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-1.10|0.3449
91695992|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.58||0.0493|TWO_SIDED|90.0|-1.94|0.0|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.94|0.0493
91695993|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.149|TWO_SIDED|90.0|-1.55|0.35|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.35|-1.55|0.1490
91695994|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.054|TWO_SIDED|90.0|-1.96|0.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.02|-1.96|0.0540
91695995|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.3119|TWO_SIDED|90.0|-1.32|0.71|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.71|-1.32|0.3119
91695996|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.3947|TWO_SIDED|90.0|-1.2|0.86|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-1.20|0.3947
91490434|NCT03281577|182853405|SUPERIORITY||Least Squares Mean Differences|0.25||||0.9419|TWO_SIDED|95.0|-1.107|1.611||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||1.611|-1.107|0.9419
91490435|NCT03281577|182853406|SUPERIORITY||Least Squares Mean Differences|33.12||||0.0436|TWO_SIDED|95.0|0.799|65.439||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||65.439|0.799|0.0436
91695997|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.4205|TWO_SIDED|90.0|-1.18|0.93|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-1.18|0.4205
91695998|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.0472|TWO_SIDED|90.0|-2.02|-0.02|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-2.02|0.0472
91695999|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.59||0.0044|TWO_SIDED|90.0|-2.55|-0.6|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.60|-2.55|0.0044
91696000|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0098|TWO_SIDED|90.0|-2.32|-0.41|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.41|-2.32|0.0098
91696001|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.1285|TWO_SIDED|90.0|-1.71|0.32|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.32|-1.71|0.1285
91696002|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.6||0.3243|TWO_SIDED|90.0|-1.27|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.27|0.3243
91696003|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.61||0.3795|TWO_SIDED|90.0|-1.2|0.82|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.82|-1.20|0.3795
91696004|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.307|TWO_SIDED|90.0|-1.35|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.35|0.3070
91696005|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.1014|TWO_SIDED|90.0|-1.74|0.22|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.22|-1.74|0.1014
91696006|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.62||0.0033|TWO_SIDED|90.0|-2.75|-0.69|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.69|-2.75|0.0033
91696007|NCT03850483|183286494|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.028|TWO_SIDED|90.0|-2.18|-0.17|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.17|-2.18|0.0280
91726800|NCT01243424|183348533|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.64|TWO_SIDED|95.47|-1.3|2.1|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|LDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||2.1|-1.3|0.6400
91726801|NCT01243424|183348533|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0497|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|HDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.0|0.0|0.0497
91726802|NCT01243424|183348533|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6823|TWO_SIDED|95.0|-2.4|1.6|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|Total cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.6|-2.4|0.6823
91726803|NCT01243424|183348534|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|3.1||0.2678|TWO_SIDED|95.0|-9.6|2.7|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||2.7|-9.6|0.2678
91726804|NCT01243424|183348535|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5165|TWO_SIDED|95.0|-0.03|0.01|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||0.01|-0.03|0.5165
91726805|NCT01243424|183348536|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.4||0.5165|TWO_SIDED|95.0|0.2|1.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.8|0.2|0.5165
91726806|NCT01243424|183348537|OTHER||geometric mean (gMean) ratio (%)|0.97||||0.2921|TWO_SIDED|95.0|0.91|1.03|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.|gMean ration= Linagliptin mean/ Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.03|0.91|0.2921
91726807|NCT01243424|183348539|EQUIVALENCE|This was the fifth step in a pre-defined hierarchical testing approach.|Mean Difference (Net)|4.13||||0.8402|TWO_SIDED|95.0|-36.46|44.71|||ANCOVA|The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.|Mean difference= Linagliptin mean- Glimepiride mean|||44.71|-36.46|0.8402
91726808|NCT01243424|183348540|OTHER||Odds Ratio (OR)|1.01||||0.9112|TWO_SIDED|95.0|0.86|1.18|||Regression, Logistic|Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.|Linagliptin vs. Glimepiride odds is presented.|This was the fifth step in a pre-defined hierarchical testing approach.||1.18|0.86|0.9112
91726809|NCT00710554|183348543|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.34||||0.139|TWO_SIDED|95.0|-0.79|0.11|||ANCOVA|||The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.11|-0.79|0.139
91726810|NCT00710554|183348544|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.86||||0.198|TWO_SIDED|95.0|-7.22|1.5|||ANCOVA|||The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||1.50|-7.22|0.198
91726811|NCT00710554|183348545|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.83||||0.007|TWO_SIDED|95.0|-1.43|-0.23|||ANCOVA|||The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||-0.23|-1.43|0.007
91696008|NCT03850483|183286494|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.0781|TWO_SIDED|90.0|-1.98|0.15|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.98|0.0781
91696009|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
91696010|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
91696011|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7362|TWO_SIDED|90.0|-12.5|5.0|||Chan and Zhang method|||Week 1||5.0|-12.5|0.7362
91696012|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 1||4.7|-12.5|0.7417
91696013|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-5.9|8.0|||Chan and Zhang method|||Week 1||8.0|-5.9|0.5000
91696014|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.7||||0.0714|TWO_SIDED|90.0|-0.8|16.9|||Chan and Zhang method|||Week 1||16.9|-0.8|0.0714
91696015|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.3||||0.0813|TWO_SIDED|90.0|-1.1|15.7|||Chan and Zhang method|||Week 1||15.7|-1.1|0.0813
91696016|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
91696017|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
91696018|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-9.6|9.6|||Chan and Zhang method|||Week 2||9.6|-9.6|0.5000
91696019|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 2||9.1|-9.4|0.4216
91696020|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.0||||0.6894|TWO_SIDED|90.0|-9.4|5.9|||Chan and Zhang method|||Week 2||5.9|-9.4|0.6894
91490436|NCT03281577|182853406|SUPERIORITY||Least Squares Mean Differences|57.98||||0.0007|TWO_SIDED|95.0|23.555|92.396||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||92.396|23.555|0.0007
91696021|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|3.7||||0.2518|TWO_SIDED|90.0|-4.2|14.3|||Chan and Zhang method|||Week 2||14.3|-4.2|0.2518
91696022|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|8.5||||0.0565|TWO_SIDED|90.0|-0.3|20.3|||Chan and Zhang method|||Week 2||20.3|-0.3|0.0565
91696023|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
91696024|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-5.6||||0.9001|TWO_SIDED|90.0|-16.5|1.9|||Chan and Zhang method|||Week 4||1.9|-16.5|0.9001
91696025|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.5000
91696026|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
91696027|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 4||12.5|-10.5|0.5054
91696028|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|3.3||||0.3401|TWO_SIDED|90.0|-8.2|16.9|||Chan and Zhang method|||Week 4||16.9|-8.2|0.3401
91696029|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|12.9||||0.0489|TWO_SIDED|90.0|0.1|27.5|||Chan and Zhang method|||Week 4||27.5|0.1|0.0489
91696030|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 6||8.4|-14.8|0.6349
91696031|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-5.6||||0.8253|TWO_SIDED|90.0|-17.2|4.4|||Chan and Zhang method|||Week 6||4.4|-17.2|0.8253
91696032|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 6||12.5|-12.5|0.5000
91696033|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.2||||0.2709|TWO_SIDED|90.0|-8.3|19.1|||Chan and Zhang method|||Week 6||19.1|-8.3|0.2709
91696034|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 6||12.5|-10.5|0.5054
91696035|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.4||||0.6319|TWO_SIDED|90.0|-12.9|9.3|||Chan and Zhang method|||Week 6||9.3|-12.9|0.6319
91696036|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.0||||0.3199|TWO_SIDED|90.0|-6.4|18.1|||Chan and Zhang method|||Week 6||18.1|-6.4|0.3199
91696037|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
91696038|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
91696039|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-8.3||||0.8808|TWO_SIDED|90.0|-20.6|2.7|||Chan and Zhang method|||Week 8||2.7|-20.6|0.8808
91696040|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4644|TWO_SIDED|90.0|-13.7|13.7|||Chan and Zhang method|||Week 8||13.7|-13.7|0.4644
91696041|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|7.8||||0.1534|TWO_SIDED|90.0|-3.4|20.9|||Chan and Zhang method|||Week 8||20.9|-3.4|0.1534
91696042|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.4||||0.4867|TWO_SIDED|90.0|-10.0|11.4|||Chan and Zhang method|||Week 8||11.4|-10.0|0.4867
91696043|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|12.3||||0.0435|TWO_SIDED|90.0|0.4|25.9|||Chan and Zhang method|||Week 8||25.9|0.4|0.0435
91490437|NCT03281577|182853406|SUPERIORITY||Least Squares Mean Differences|44.44||||0.0134|TWO_SIDED|95.0|8.249|80.629||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||80.629|8.249|0.0134
91490438|NCT03281577|182853407|SUPERIORITY||Least Squares Mean Differences|-10.27||||0.0789|TWO_SIDED|95.0|-21.507|0.96||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.960|-21.507|0.0789
91696044|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 10||8.4|-14.8|0.6349
91696045|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4565|TWO_SIDED|90.0|-12.6|12.5|||Chan and Zhang method|||Week 10||12.5|-12.6|0.4565
91696046|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 10||12.5|-12.5|0.5000
91696047|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|7.9||||0.1765|TWO_SIDED|90.0|-5.7|21.8|||Chan and Zhang method|||Week 10||21.8|-5.7|0.1765
91696048|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|0.3||||0.5013|TWO_SIDED|90.0|-14.0|15.2|||Chan and Zhang method|||Week 10||15.2|-14.0|0.5013
91726812|NCT00710554|183348546|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.08||||0.795|TWO_SIDED|95.0|-0.52|0.68|||ANCOVA|||The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.68|-0.52|0.795
91490439|NCT03281577|182853407|SUPERIORITY||Least Squares Mean Differences|-13.28||||0.027|TWO_SIDED|95.0|-25.242|-1.314||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-1.314|-25.242|0.0270
91490440|NCT03281577|182853407|SUPERIORITY||Least Squares Mean Differences|-11.63||||0.075|TWO_SIDED|95.0|-24.206|0.952||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.952|-24.206|0.0750
91528229|NCT01370005|182931722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.5|-2.83||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.83|-5.50|<0.0001
91490441|NCT01594281|182853420|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.8||||0.0344|TWO_SIDED|95.0|-5.4|-0.2|||ANCOVA|||||-0.2|-5.4|0.0344
91696049|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-7.8||||0.7969|TWO_SIDED|90.0|-20.7|5.9|||Chan and Zhang method|||Week 10||5.9|-20.7|0.7969
91696050|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6424|TWO_SIDED|90.0|-16.4|10.6|||Chan and Zhang method|||Week 10||10.6|-16.4|0.6424
91696051|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
91696052|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|2.8||||0.3402|TWO_SIDED|90.0|-7.0|13.4|||Chan and Zhang method|||Week 14||13.4|-7.0|0.3402
91696053|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.8||||0.1743|TWO_SIDED|90.0|-4.5|17.6|||Chan and Zhang method|||Week 14||17.6|-4.5|0.1743
91696054|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
91696055|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|2.6||||0.3534|TWO_SIDED|90.0|-7.8|15.4|||Chan and Zhang method|||Week 14||15.4|-7.8|0.3534
91696056|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.5||||0.2508|TWO_SIDED|90.0|-5.5|18.8|||Chan and Zhang method|||Week 14||18.8|-5.5|0.2508
91696057|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|1.9||||0.4238|TWO_SIDED|90.0|-8.2|13.6|||Chan and Zhang method|||Week 14||13.6|-8.2|0.4238
91696058|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|5.9||||0.2696|TWO_SIDED|90.0|-6.2|19.3|||Chan and Zhang method|||Week 16||19.3|-6.2|0.2696
91696059|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|3.0||||0.3648|TWO_SIDED|90.0|-8.6|15.3|||Chan and Zhang method|||Week 16||15.3|-8.6|0.3648
91696060|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|8.7||||0.1267|TWO_SIDED|90.0|-3.8|22.2|||Chan and Zhang method|||Week 16||22.2|-3.8|0.1267
91696061|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|10.7||||0.0832|TWO_SIDED|90.0|-2.5|24.4|||Chan and Zhang method|||Week 16||24.4|-2.5|0.0832
91696062|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|6.5||||0.2099|TWO_SIDED|90.0|-5.7|21.3|||Chan and Zhang method|||Week 16||21.3|-5.7|0.2099
91696063|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|3.6||||0.3474|TWO_SIDED|90.0|-8.0|17.4|||Chan and Zhang method|||Week 16||17.4|-8.0|0.3474
91696064|NCT03850483|183286498|SUPERIORITY||Risk Difference (RD)|8.1||||0.2124|TWO_SIDED|90.0|-4.0|21.6|||Chan and Zhang method|||Week 16||21.6|-4.0|0.2124
91696065|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|13.7||||0.0544|TWO_SIDED|90.0|-0.3|27.9|||Chan and Zhang method|||Week 1||27.9|-0.3|0.0544
91696066|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|6.1||||0.2697|TWO_SIDED|90.0|-6.3|19.6|||Chan and Zhang method|||Week 1||19.6|-6.3|0.2697
91696067|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|16.5||||0.0286|TWO_SIDED|90.0|2.0|31.0|||Chan and Zhang method|||Week 1||31.0|2.0|0.0286
91696068|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|7.8||||0.1512|TWO_SIDED|90.0|-4.7|20.8|||Chan and Zhang method|||Week 1||20.8|-4.7|0.1512
91696069|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-7.7||||0.79|TWO_SIDED|90.0|-21.9|7.4|||Chan and Zhang method|||Week 1||7.4|-21.9|0.7900
91696070|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|7.3||||0.3137|TWO_SIDED|90.0|-8.5|24.0|||Chan and Zhang method|||Week 1||24.0|-8.5|0.3137
91696071|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|5.0||||0.3789|TWO_SIDED|90.0|-10.9|22.6|||Chan and Zhang method|||Week 1||22.6|-10.9|0.3789
91696072|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|13.7||||0.0636|TWO_SIDED|90.0|-1.0|28.5|||Chan and Zhang method|||Week 2||28.5|-1.0|0.0636
91696073|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|9.6||||0.1435|TWO_SIDED|90.0|-4.9|24.5|||Chan and Zhang method|||Week 2||24.5|-4.9|0.1435
91696074|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|25.7||||0.0058|TWO_SIDED|90.0|8.9|42.4|||Chan and Zhang method|||Week 2||42.4|8.9|0.0058
91696075|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|22.9||||0.0112|TWO_SIDED|90.0|6.5|38.9|||Chan and Zhang method|||Week 2||38.9|6.5|0.0112
91696076|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|4.9||||0.3349|TWO_SIDED|90.0|-10.8|21.3|||Chan and Zhang method|||Week 2||21.3|-10.8|0.3349
91696077|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|10.6||||0.2065|TWO_SIDED|90.0|-6.1|27.7|||Chan and Zhang method|||Week 2||27.7|-6.1|0.2065
91490442|NCT01594281|182853420|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-1.2||||0.3809|TWO_SIDED|95.0|-3.8|1.5|||ANCOVA|||||1.5|-3.8|0.3809
91490443|NCT01594281|182853420|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|1.7||||0.2113|TWO_SIDED|95.0|-1.0|4.3|||ANCOVA|||||4.3|-1.0|0.2113
91490444|NCT01594281|182853421|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.4||||0.0081|TWO_SIDED|95.0|-4.2|-0.6|||ANCOVA|||||-0.6|-4.2|0.0081
91490445|NCT01594281|182853421|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-0.3||||0.7494|TWO_SIDED|95.0|-2.0|1.5|||ANCOVA|||||1.5|-2.0|0.7494
91490446|NCT01594281|182853421|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|2.1||||0.0175|TWO_SIDED|95.0|0.4|3.9|||ANCOVA|||||3.9|0.4|0.0175
91696078|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|11.4||||0.1871|TWO_SIDED|90.0|-5.6|29.1|||Chan and Zhang method|||Week 2||29.1|-5.6|0.1871
91490447|NCT01594281|182853422|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|5.5||||0.0495|TWO_SIDED|95.0|0.0|11.0|||ANCOVA|||||11.0|0.0|0.0495
91490448|NCT01594281|182853422|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|3.0||||0.2767|TWO_SIDED|95.0|-2.5|8.5|||ANCOVA|||||8.5|-2.5|0.2767
91490449|NCT01594281|182853422|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.5||||0.3641|TWO_SIDED|95.0|-7.9|2.9|||ANCOVA|||||2.9|-7.9|0.3641
91490450|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.47||||0.4019|TWO_SIDED|95.0|0.08|2.749|||Regression, Logistic|||≥10 letters gain||2.749|0.080|0.4019
91490451|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.833||||0.2772|TWO_SIDED|95.0|0.614|5.471|||Regression, Logistic|||≥5 letters gain||5.471|0.614|0.2772
91490452|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.412||||0.4731|TWO_SIDED|95.0|0.55|3.622|||Regression, Logistic|||No clinically relevant change||3.622|0.55|0.4731
91696079|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|13.4||||0.1245|TWO_SIDED|90.0|-4.9|31.4|||Chan and Zhang method|||Week 4||31.4|-4.9|0.1245
91490453|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.35||||0.065|TWO_SIDED|95.0|0.155|1.068|||Regression, Logistic|||≥5 letters loss||1.068|0.155|0.065
91490454|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.229|4.361|||Regression, Logistic|||≥10 letters loss||4.361|0.229|1.000
91490455|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.314||||0.3261|TWO_SIDED|95.0|0.031|3.173|||Regression, Logistic|||≥15 letters loss||3.173|0.031|0.3261
91490456|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.667||||0.668|TWO_SIDED|95.0|0.104|4.253|||Regression, Logistic|||≥10 letters gain||4.253|0.104|0.6680
91490457|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|2.842||||0.0838|TWO_SIDED|95.0|0.87|9.283|||Regression, Logistic|||≥5 letters gain||9.283|0.870|0.0838
91490458|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.674||||0.4116|TWO_SIDED|95.0|0.263|1.729|||Regression, Logistic|||No clinically relevant change||1.729|0.263|0.4116
91696080|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|14.0||||0.128|TWO_SIDED|90.0|-4.7|33.7|||Chan and Zhang method|||Week 4||33.7|-4.7|0.1280
91696081|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|32.9||||0.003|TWO_SIDED|90.0|12.4|50.5|||Chan and Zhang method|||Week 4||50.5|12.4|0.0030
91696082|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|22.6||||0.0235|TWO_SIDED|90.0|3.1|40.6|||Chan and Zhang method|||Week 4||40.6|3.1|0.0235
91696083|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|4.9||||0.3728|TWO_SIDED|90.0|-13.6|24.1|||Chan and Zhang method|||Week 4||24.1|-13.6|0.3728
91696084|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|25.5||||0.0153|TWO_SIDED|90.0|4.0|43.6|||Chan and Zhang method|||Week 4||43.6|4.0|0.0153
91696085|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|9.4||||0.2543|TWO_SIDED|90.0|-8.8|27.8|||Chan and Zhang method|||Week 4||27.8|-8.8|0.2543
91696086|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|7.9||||0.2785|TWO_SIDED|90.0|-10.2|26.4|||Chan and Zhang method|||Week 6||26.4|-10.2|0.2785
91696087|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|13.3||||0.1434|TWO_SIDED|90.0|-7.4|33.7|||Chan and Zhang method|||Week 6||33.7|-7.4|0.1434
91696088|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|36.1||||0.0015|TWO_SIDED|90.0|12.8|54.1|||Chan and Zhang method|||Week 6||54.1|12.8|0.0015
91696089|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|24.1||||0.0242|TWO_SIDED|90.0|3.4|43.9|||Chan and Zhang method|||Week 6||43.9|3.4|0.0242
91696090|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|35.1||||0.0037|TWO_SIDED|90.0|10.0|54.1|||Chan and Zhang method|||Week 6||54.1|10.0|0.0037
91696091|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|16.6||||0.1037|TWO_SIDED|90.0|-4.9|36.7|||Chan and Zhang method|||Week 6||36.7|-4.9|0.1037
91696092|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|1.8||||0.4607|TWO_SIDED|90.0|-17.7|22.5|||Chan and Zhang method|||Week 6||22.5|-17.7|0.4607
91696093|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|12.2||||0.1725|TWO_SIDED|90.0|-8.0|31.9|||Chan and Zhang method|||Week 8||31.9|-8.0|0.1725
91726813|NCT00710554|183348547|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.233|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.09|-0.37|0.233
91726814|NCT00710554|183348548|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.762||||0.023|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.||2.88|1.08|0.023
91726815|NCT00710554|183348549|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.25||||0.288|TWO_SIDED|95.0|-0.72|0.21|||ANCOVA|||The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||0.21|-0.72|0.288
91696094|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|22.8||||0.0451|TWO_SIDED|90.0|0.2|43.6|||Chan and Zhang method|||Week 8||43.6|0.2|0.0451
91696095|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|44.4||||0.0003|TWO_SIDED|90.0|21.3|62.9|||Chan and Zhang method|||Week 8||62.9|21.3|0.0003
91696096|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|26.7||||0.0239|TWO_SIDED|90.0|3.8|47.6|||Chan and Zhang method|||Week 8||47.6|3.8|0.0239
91696097|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|20.8||||0.0643|TWO_SIDED|90.0|-2.1|41.2|||Chan and Zhang method|||Week 8||41.2|-2.1|0.0643
91696098|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-6.0||||0.6676|TWO_SIDED|90.0|-25.9|15.9|||Chan and Zhang method|||Week 8||15.9|-25.9|0.6676
91696099|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|17.6||||0.0898|TWO_SIDED|90.0|-4.2|37.8|||Chan and Zhang method|||Week 8||37.8|-4.2|0.0898
91696100|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|11.8||||0.2707|TWO_SIDED|90.0|-10.1|32.9|||Chan and Zhang method|||Week 10||32.9|-10.1|0.2707
91696101|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|9.0||||0.2981|TWO_SIDED|90.0|-14.2|31.0|||Chan and Zhang method|||Week 10||31.0|-14.2|0.2981
91696102|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|31.0||||0.011|TWO_SIDED|90.0|8.0|51.4|||Chan and Zhang method|||Week 10||51.4|8.0|0.0110
91696103|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|33.3||||0.0083|TWO_SIDED|90.0|9.1|53.2|||Chan and Zhang method|||Week 10||53.2|9.1|0.0083
91696104|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|4.8||||0.4217|TWO_SIDED|90.0|-18.3|27.5|||Chan and Zhang method|||Week 10||27.5|-18.3|0.4217
91696105|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|1.3||||0.5152|TWO_SIDED|90.0|-20.8|23.2|||Chan and Zhang method|||Week 10||23.2|-20.8|0.5152
91696106|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-11.8||||0.7002|TWO_SIDED|90.0|-33.1|11.7|||Chan and Zhang method|||Week 10||11.7|-33.1|0.7002
91696107|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|27.6||||0.0169|TWO_SIDED|90.0|5.2|47.9|||Chan and Zhang method|||Week 12||47.9|5.2|0.0169
91696108|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|25.9||||0.0283|TWO_SIDED|90.0|3.2|46.2|||Chan and Zhang method|||Week 12||46.2|3.2|0.0283
91696109|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|37.9||||0.002|TWO_SIDED|90.0|14.3|57.1|||Chan and Zhang method|||Week 12||57.1|14.3|0.0020
91696110|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|31.4||||0.0095|TWO_SIDED|90.0|8.4|51.5|||Chan and Zhang method|||Week 12||51.5|8.4|0.0095
91696111|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|21.0||||0.0798|TWO_SIDED|90.0|-2.7|42.6|||Chan and Zhang method|||Week 12||42.6|-2.7|0.0798
91696112|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|10.9||||0.2848|TWO_SIDED|90.0|-11.3|31.8|||Chan and Zhang method|||Week 12||31.8|-11.3|0.2848
91696113|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|0.5||||0.5062|TWO_SIDED|90.0|-21.1|23.1|||Chan and Zhang method|||Week 12||23.1|-21.1|0.5062
91696114|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|36.9||||0.0012|TWO_SIDED|90.0|16.7|55.3|||Chan and Zhang method|||Week 14||55.3|16.7|0.0012
91696115|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|38.7||||0.0007|TWO_SIDED|90.0|17.3|57.4|||Chan and Zhang method|||Week 14||57.4|17.3|0.0007
91696116|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|47.0||||0.0001|TWO_SIDED|90.0|24.6|65.1|||Chan and Zhang method|||Week 14||65.1|24.6|0.0001
91535597|NCT00991276|182949768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.32|STANDARD_ERROR_OF_MEAN|5.31|<|0.0001|TWO_SIDED|95.0|-35.83|-14.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-14.80|-35.83|<0.0001
91696117|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|29.9||||0.0039|TWO_SIDED|90.0|9.5|48.7|||Chan and Zhang method|||Week 14||48.7|9.5|0.0039
91696118|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|4.5||||0.3895|TWO_SIDED|90.0|-17.5|26.5|||Chan and Zhang method|||Week 14||26.5|-17.5|0.3895
91696119|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|10.1||||0.2793|TWO_SIDED|90.0|-11.8|31.8|||Chan and Zhang method|||Week 14||31.8|-11.8|0.2793
91696120|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-8.5||||0.7027|TWO_SIDED|90.0|-28.4|12.2|||Chan and Zhang method|||Week 14||12.2|-28.4|0.7027
91696121|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|37.0||||0.0009|TWO_SIDED|90.0|15.4|55.2|||Chan and Zhang method|||Week 16||55.2|15.4|0.0009
91696122|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|23.0||||0.0205|TWO_SIDED|90.0|4.1|43.2|||Chan and Zhang method|||Week 16||43.2|4.1|0.0205
91696123|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|46.8||||0.0001|TWO_SIDED|90.0|24.6|65.7|||Chan and Zhang method|||Week 16||65.7|24.6|0.0001
91696124|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|44.6||||0.0002|TWO_SIDED|90.0|21.5|62.9|||Chan and Zhang method|||Week 16||62.9|21.5|0.0002
91696125|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-18.5||||0.9209|TWO_SIDED|90.0|-38.3|3.2|||Chan and Zhang method|||Week 16||3.2|-38.3|0.9209
91696126|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-13.9||||0.793|TWO_SIDED|90.0|-34.4|8.7|||Chan and Zhang method|||Week 16||8.7|-34.4|0.7930
91696127|NCT03850483|183286499|SUPERIORITY||Risk Difference (RD)|-5.1||||0.6156|TWO_SIDED|90.0|-28.0|20.1|||Chan and Zhang method|||Week 16||20.1|-28.0|0.6156
91696128|NCT01222520|183286531|SUPERIORITY_OR_OTHER||Least square mean difference|9.14|||<|0.0001||95.0|7.09|11.18|||ANCOVA|||||11.18|7.09|<0.0001
91696129|NCT01222520|183286532|SUPERIORITY_OR_OTHER||Least square mean difference|14.88|||<|0.0001||95.0|11.82|17.94|||ANCOVA|||||17.94|11.82|<0.0001
91696130|NCT01222520|183286533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91696131|NCT01222520|183286534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91696132|NCT01222520|183286535|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91696133|NCT01222520|183286536|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91696134|NCT01222520|183286537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91696135|NCT04081610|183286549|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through the incidence of AD.|Median Difference (Final Values)|0.05||||0.409|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.409
91696136|NCT04081610|183286550|NON_INFERIORITY|Compare the tolerability of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit-dose manufactured by Sophia Laboratories S.A. of C.V. using the ICO score.||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
91696137|NCT04081610|183286550|EQUIVALENCE|F=2.606, 15.926||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.009
91696138|NCT04081610|183286550|EQUIVALENCE|F=3.051, 19.336||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.002
91696139|NCT04081610|183286551|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through changes in BCVA.||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||0.904
91696140|NCT04081610|183286551|EQUIVALENCE|F=-1.414, 1.061||||||0.157|||||||Sign test|||Final vs initial VA||||0.157
91696141|NCT04081610|183286551|EQUIVALENCE|||||||1|||||||Sign test|||Final vs initial VA||||1.000
91696142|NCT04081610|183286552|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in corneal and conjunctival staining with fluorescein.||||||1|||||||Fisher Exact|||||||1.000
91696143|NCT04081610|183286552|EQUIVALENCE|Chi-squared (2)= 6.400||||||0.041|||||||Chi-squared|||Final vs initial fluorescein staining||||0.041
91696144|NCT04081610|183286552|EQUIVALENCE|Chi-squared (2)=0.814||||||0.665|||||||Chi-squared|||||||0.665
91696145|NCT04081610|183286553|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes of corneal and conjunctival staining with lysamine green.||||||0.713|||||||Fisher Exact|||||||0.713
91696146|NCT04081610|183286553|EQUIVALENCE|Chi-squared (3)=14.345||||||0.002|||||||Chi-squared|||Final vs initial lissamine green staining||||0.002
91696147|NCT04081610|183286553|EQUIVALENCE|Chi-squared (2)=0.506||||||0.777|||||||Chi-squared|||Final vs initial lissamine green staining||||0.777
91696148|NCT04081610|183286554|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in conjunctival hyperemia.||||||1|||||||Chi-squared, Corrected|||||||1.000
91696149|NCT04081610|183286554|EQUIVALENCE|F=4.167, 1||||||0.031|||||||Fisher Exact|||Final vs initial conjunctival hyperemia||||0.031
91696150|NCT04081610|183286554|EQUIVALENCE|No significant change was observed.||||||1|||||||Chi-squared, Corrected|||Final vs initial conjunctival hyperemia||||1.000
91726816|NCT00710554|183348550|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.01||||0.617|TWO_SIDED|95.0|-0.06|0.04|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||0.04|-0.06|0.617
91726817|NCT00710554|183348551|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|2.459||0.76|TWO_SIDED|95.0|-5.6|4.09|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||4.09|-5.60|0.76
91726818|NCT00710554|183348552|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.38||||0.112|TWO_SIDED|95.0|-0.85|0.09|||ANCOVA|||The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.||0.09|-0.85|0.112
91726819|NCT00292370|183348577|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91726820|NCT03737032|183348597|SUPERIORITY|||||||0.8|||||||ANOVA|||Null hypothesis: post-TBS dmPFC activation will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.80
91726821|NCT03737032|183348598|SUPERIORITY|||||||0.23|||||||ANOVA|Repeated measures ANOVA with time (pre or post), condition (cTBS, iTBS, sham TBS), and time\*condition effects.||Null hypothesis: pre-post change in positive affect will not vary by TBS condition. This is tested using the interaction of time\*condition in a repeated measures model.||||0.23
91726822|NCT03737032|183348599|SUPERIORITY|||||||0.84|||||||ANOVA|||Null hypothesis: post-TBS functional connectivity between the dmPFC and ventral striatum (VS) will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.84
91726823|NCT01368185|183348605|SUPERIORITY_OR_OTHER_LEGACY||% change SUA from baseline|4.6|STANDARD_DEVIATION|0.9|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SUA minus baseline SUA.|Comparison between Month 3 and Baseline||||<0.01
91726824|NCT01368185|183348606|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||||||<0.0001
91726825|NCT01368185|183348607|SUPERIORITY_OR_OTHER_LEGACY||% change DBP from Baseline|-7.1|STANDARD_DEVIATION|0.4|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 DBP minus baseline DBP (n=1239).|Comparison between Month 3 and Baseline||||<0.01
91726826|NCT01368185|183348608|SUPERIORITY_OR_OTHER_LEGACY||% change SBP from Baseline|-9.1|STANDARD_DEVIATION|0.3|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SBP minus baseline SBP (n=1245).|Comparison between Month 3 and Baseline||||<0.01
91726827|NCT04535362|183348614|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.63||0.93|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.93
91726828|NCT04535362|183348615|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.68
91726829|NCT04535362|183348617|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.51||0.37|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.37
91726830|NCT04535362|183348618|SUPERIORITY||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|0.98||0.2|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.20
91696151|NCT00497289|183286560|SUPERIORITY|||||||0.3654|||||||Wilcoxon (Mann-Whitney)|||||||0.3654
91696152|NCT00497289|183286561|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
91696153|NCT04606394|183286562|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.33|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.33
91696154|NCT04606394|183286563|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.04
91696155|NCT02920008|183286591|SUPERIORITY||||||=|0.3287|||||||Stratified log-rank|||||||= 0.3287
91696156|NCT03852264|183286630|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|2.61|||||TWO_SIDED|90.0|-1.29|6.38|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||6.38|-1.29|
91726831|NCT02421510|183348626|SUPERIORITY||Least squares mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.058|<|0.001|TWO_SIDED|95.0|-0.48|-0.25||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||-0.25|-0.48|< 0.001
91726832|NCT02421510|183348626|SUPERIORITY||Least squares mean difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.47|-0.24||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from Mixed effect Model Repeat Measurement (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C- by-time interaction as a covariate.||-0.24|-0.47|< 0.001
91760021|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.59|-0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-0.59|
91490459|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.621||||0.4197|TWO_SIDED|95.0|0.195|1.977|||Regression, Logistic|||≥5 letters loss||1.977|0.195|0.4197
91696157|NCT03852264|183286630|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|1.62|||||TWO_SIDED|90.0|-2.18|5.45|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||5.45|-2.18|
91696158|NCT03852264|183286630|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-4.93|2.83|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||2.83|-4.93|
91696159|NCT03852264|183286631|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.3482|||||TWO_SIDED|90.0|-0.476|1.211|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||1.211|-0.476|
91696160|NCT03852264|183286631|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.0635|||||TWO_SIDED|90.0|-0.931|0.803|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.803|-0.931|
91696161|NCT03852264|183286631|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.422|||||TWO_SIDED|90.0|-1.319|0.445|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.445|-1.319|
91696162|NCT03852264|183286632|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.468|||||TWO_SIDED|90.0|-101.0|99.5|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||99.5|-101|
91696163|NCT03852264|183286632|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.0|||||TWO_SIDED|90.0|-225.0|-15.5|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-15.5|-225|
91696164|NCT03852264|183286632|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.48|||||TWO_SIDED|90.0|-223.0|-16.2|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-16.2|-223|
91696165|NCT02411396|183286641|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Mean Difference (Final Values)|124.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|118.3|130.9||||||This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.||130.9|118.3|
91696166|NCT02411396|183286642|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|5.14|||||TWO_SIDED|95.0|4.13|6.41|||||VOC in patients with SCD whom went to EDs represents the numerator, VOC in patients with SCD whom went to ICs represents the denominator for Odds Ratio.|||6.41|4.13|
91696167|NCT02411396|183286643|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.84|2.72|||||VOC in patients with SCD whom went to ICs represents the numerator, VOC in patients with SCD whom went to EDs represents the denominator for Odds Ratio.|||2.72|1.84|
91696168|NCT01631149|183286646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|0.4|<|0.001|||||||t-test, 2 sided|||"The individual scores obtained during surgery were averaged.~The average values were compared using a t-test between treatments."||||<0.001
91760022|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.51|-0.12||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.12|-0.51|
91726833|NCT02421510|183348627|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|16.3|||<|0.001|TWO_SIDED|95.0|9.17|23.43||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 200 mg versus Placebo|P-values were obtained from a Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%). The 95% Confidence Limits (CL) were calculated using asymptotic Wald method. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.||23.43|9.17|< 0.001
91726834|NCT02421510|183348627|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|17.2|||<|0.001|TWO_SIDED|95.0|10.06|24.35||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 400 mg versus Placebo|P-values were obtained from a CMH test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%). The 95% CL were calculated using asymptotic Wald method.||24.35|10.06|< 0.001
91726835|NCT02421510|183348628|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.53|-1.44||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-1.44|-2.53|< 0.001
91760023|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.55|-0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.16|-0.55|
91490460|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
91490461|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.029||||0.9839|TWO_SIDED|95.0|0.062|17.127|||Regression, Logistic|||≥15 letters loss||17.127|0.062|0.9839
91490462|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.663|TWO_SIDED|95.0|0.294|6.858|||Regression, Logistic|||≥10 letters gain||6.858|0.294|0.6630
91490463|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.55||||0.4941|TWO_SIDED|95.0|0.441|5.444||P-value was calculated as a point estimate.|Regression, Logistic|||≥5 letters gain||5.444|0.441|0.4941
91490464|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.477||||0.1259|TWO_SIDED|95.0|0.185|1.231|||Regression, Logistic|||No clinically relevant change||1.231|0.185|0.1259
91490465|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.773||||0.271|TWO_SIDED|95.0|0.64|4.913|||Regression, Logistic|||≥5 letters loss||4.913|0.640|0.2710
91490466|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
91490467|NCT01594281|182853423|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|3.282||||0.314|TWO_SIDED|95.0|0.325|33.171|||Regression, Logistic|||≥15 letters loss||33.171|0.325|0.3140
91490468|NCT01594281|182853424|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.994||||0.9918|TWO_SIDED|95.0|0.327|3.026|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||3.026|0.327|0.9918
91490469|NCT01594281|182853424|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.607||||0.3595|TWO_SIDED|95.0|0.209|1.765|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.765|0.209|0.3595
91490470|NCT01594281|182853424|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.611||||0.3787|TWO_SIDED|95.0|0.204|1.83|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.830|0.204|0.3787
91490471|NCT01594281|182853424|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.889||||0.9097|TWO_SIDED|95.0|0.116|6.806|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||6.806|0.116|0.9097
91490472|NCT01594281|182853424|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.341||||0.223|TWO_SIDED|95.0|0.06|1.925|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||1.925|0.060|0.2230
91726836|NCT02421510|183348628|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-3.12|-2.04|||MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-2.04|-3.12|< 0.001
91726837|NCT02421510|183348629|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.847|<|0.001|TWO_SIDED|95.0|-4.86|-1.53||Threshold for significance \<=0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.53|-4.86|< 0.001
91726838|NCT02421510|183348629|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.59|STANDARD_ERROR_OF_MEAN|0.845|<|0.001|TWO_SIDED|95.0|-5.25|-1.93||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.93|-5.25|< 0.001
91726839|NCT02421510|183348630|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-21.6|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-32.2|-11.0||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-11|-32.2|< 0.001
91726840|NCT02421510|183348630|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.37|<|0.001|TWO_SIDED|95.0|-36.2|-15.1||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-15.1|-36.2|< 0.001
91726841|NCT02421510|183348631|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.3|2.7||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.7|1.3|< 0.001
91726842|NCT02421510|183348631|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|1.0|2.4||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.4|1|< 0.001
91726843|NCT02421510|183348632|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.025|TWO_SIDED|95.0|-0.6|0.0||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||0|-0.6|0.025
91726844|NCT02421510|183348632|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||-0.2|-0.7|0.003
91490473|NCT01594281|182853424|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.383||||0.2792|TWO_SIDED|95.0|0.068|2.177|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||2.177|0.068|0.2792
91726845|NCT03203512|183348634|SUPERIORITY||||||<|0.001||||||Treatment effect: p\<0.001; period effect : p=0.552; treatment x period interaction: p=0.622|ANOVA|||Null hypothesis is that there was no difference in change of total EV numbers detected by NTA between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total EV numbers.||||<0.001
91726846|NCT03203512|183348635|SUPERIORITY||||||=|0.001||||||Treatment: p=0.001; period: p=0.646; treatment x period interaction: p=0.267|ANOVA|||Null hypothesis is that there was no difference in change of total PS+EV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total PS+EV numbers.||||=0.001
91726847|NCT03203512|183348636|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.350; treatment x period interaction: p=0.572|ANOVA|||Null hypothesis is that there was no difference in change of PDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on PDEV numbers.||||=0.002
91490474|NCT01594281|182853425|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-40.7||||0.0003|TWO_SIDED|95.0|-62.1|-19.3|||ANCOVA|||||-19.3|-62.1|0.0003
91696169|NCT02016105|183286663|EQUIVALENCE|Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval \[-18%, 18%\].|Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|4.75|||TWO_SIDED|95.0|-7.46|11.15||||||||11.15|-7.46|
91696170|NCT02016105|183286664|EQUIVALENCE|"LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.~Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval \[-15%; 15%\]."|LS means difference|0.8|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-3.15|4.84||||||||4.84|-3.15|
91696171|NCT02016105|183286665|EQUIVALENCE|LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval \[-15%; 15%\].|LS means difference|1.2|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-2.78|5.08||||||||5.08|-2.78|
91696172|NCT03521115|183286700|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.01|TWO_SIDED||||||Regression, Logistic|b=-.91, controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
91696173|NCT03521115|183286700|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.1|TWO_SIDED||||||Regression, Logistic||Controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
91696174|NCT03521115|183286700|SUPERIORITY||Chi-Square|5.129||||0.077|TWO_SIDED||||||Chi-squared|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||.077
91696175|NCT03521115|183286701|SUPERIORITY||b|-0.47|||<|0.001|TWO_SIDED||||||Regression, Linear|Controled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.001
91696176|NCT03521115|183286701|SUPERIORITY||b|-0.97|||<|0.01|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
91760024|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.38|0.01||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.01|-0.38|
91726848|NCT03203512|183348636|SUPERIORITY|Null hypothesis is that there was no difference in change of EDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EDEV numbers.|||||<|0.001||||||Treatment: p\<0.001; period: p=0.362; treatment x period interaction: p=0.225|ANOVA|||||||<0.001
91726849|NCT03203512|183348637|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.010; treatment x period: p=0.608|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting lag time for TF-dependent thrombin generation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
91726850|NCT03203512|183348638|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.073; treatment x period: p=0.667|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent thrombin peak concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
91726851|NCT03203512|183348639|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.138; treatment x period: p=0.872|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting the time to reach peak TF-dependent thrombin concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
91726852|NCT03203512|183348640|SUPERIORITY||||||=|0.015||||||Treatment: p=0.015; period: p=0.059; treatment x period: p=0.220|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent velocity index between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||=0.015
91726853|NCT03203512|183348641|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.118; treatment x period: p=0.802|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent endogenous thrombin potential (ETP) between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
91528230|NCT01370005|182931723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.4||0.0008|TWO_SIDED|95.0|-2.15|-0.56||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.56|-2.15|0.0008
91726854|NCT03203512|183348642|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to ADP between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
91726855|NCT03203512|183348642|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to epinephrine between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
91726856|NCT03203512|183348642|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to TRAP-6 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
91726857|NCT03203512|183348642|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to U46619 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
91726858|NCT03203512|183348643|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to CRP-XL between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
91726859|NCT03203512|183348644|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting endpoint for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
91726860|NCT03203512|183348644|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affectingamximum for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
91726861|NCT03203512|183348645|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting area under curve for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
91726862|NCT03203512|183348646|SUPERIORITY||||||<|0.001||||||Treatment: \<0.001; period: p=0.978; treatment x period interaction: p=0.140|ANOVA|||Null hypothesis is that there was no difference in change of EPA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in circulating EV total lipids.||||<0.001
91726863|NCT03203512|183348646|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.699; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DHA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in circulating EV total lipids.||||<0.001
91726864|NCT03203512|183348646|SUPERIORITY||||||=|0.011||||||Treatment: p=0.011; period: p=0.381; treatment x period interaction: p=0.762|ANOVA|||Null hypothesis is that there was no difference in change of oleic acid in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on oleic acid in circulating EV total lipids.||||=0.011
91726865|NCT03203512|183348646|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.512; treatment x period interaction: p=0.812|ANOVA|||Null hypothesis is that there was no difference in change of AA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in circulating EV total lipids.||||<0.001
91726866|NCT03203512|183348646|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.160; treatment x period interaction: p=0.132|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in circulating EV total lipids.||||<0.001
91726867|NCT03203512|183348646|SUPERIORITY||||||=|0.013||||||Treatment: p=0.013; period: p=0.500; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of total MUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total MUFA in circulating EV total lipids.||||=0.013
91726868|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.169; treatment x period interaction: p=0.629|ANOVA|||Null hypothesis is that there was no difference in change of EPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in plasma total phospholipids.||||<0.001
91726869|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.262; treatment x period interaction: p=0.150|ANOVA|||Null hypothesis is that there was no difference in change of DHA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in plasma total phospholipids.||||<0.001
91726870|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.302; treatment x period interaction: p=0.385|ANOVA|||Null hypothesis is that there was no difference in change of DPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DPA in plasma total phospholipids.||||<0.001
91726871|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.793; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of linoleic acid in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on linoleic acid in plasma total phospholipids.||||<0.001
91726872|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.956; treatment x period interaction: p=0.238|ANOVA|||Null hypothesis is that there was no difference in change of dihomo-γ-linolenic acid (DGLA) in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DGLA in plasma total phospholipids.||||<0.001
91726873|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.457; treatment x period interaction: p=0.613|ANOVA|||Null hypothesis is that there was no difference in change of AA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in plasma total phospholipids.||||<0.001
91726874|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.134; treatment x period interaction: p=0.260|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in plasma total phospholipids.||||<0.001
91490475|NCT01594281|182853425|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-22.9||||0.0357|TWO_SIDED|95.0|-44.2|-1.6|||ANCOVA|||||-1.6|-44.2|0.0357
91490476|NCT01594281|182853425|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|17.8||||0.1034|TWO_SIDED|95.0|-3.7|39.3|||ANCOVA|||||39.3|-3.7|0.1034
91490477|NCT01594281|182853426|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-51.7||||0.0007|TWO_SIDED|95.0|-81.1|-22.3|||ANCOVA|||||-22.3|-81.1|0.0007
91490478|NCT01594281|182853426|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-28.9||||0.0542|TWO_SIDED|95.0|-58.4|0.5|||ANCOVA|||||0.5|-58.4|0.0542
91490479|NCT01594281|182853426|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|22.8||||0.1288|TWO_SIDED|95.0|-6.7|52.3|||ANCOVA|||||52.3|-6.7|0.1288
91490480|NCT01890473|182853463|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.908|||||TWO_SIDED|90.0|0.815|1.01||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale (using log (Cmax) without a formal test.||1.01|0.815|
91726875|NCT03203512|183348647|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.917; treatment x period interaction: p=0.603|ANOVA|||Null hypothesis is that there was no difference in change of total n-6 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-6 PUFA in plasma total phospholipids.||||<0.001
91726876|NCT03203512|183348648|SUPERIORITY||||||=|0.016||||||Treatment: p=0.016; period: p=0.566; treatment x period interaction: p=0.659|ANOVA|||Null hypothesis is that there was no difference in change of plasma TAG between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TAG.||||=0.016
91490481|NCT01890473|182853464|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.941|||||TWO_SIDED|90.0|0.843|1.05||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log (AUC (0-T) without a formal test.||1.05|0.843|
91490482|NCT01890473|182853465|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.976|||||TWO_SIDED|90.0|0.888|1.07||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log AUC(INF) without a formal test.||1.07|0.888|
91490483|NCT01945281|182853474|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-24.3|27.7|||||Caspofungin minus Amphotericin|||27.7|-24.3|
91490484|NCT01945281|182853475|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-30.2|22.6|||||Caspofungin minus Amphotericin|||22.6|-30.2|
91490485|NCT02478632|182853501|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.014|TWO_SIDED|95.0|0.27|2.31|||ANCOVA|||||2.31|0.27|0.014
91490486|NCT02478632|182853502|SUPERIORITY||Mean Difference (Final Values)|1.32||||0.039|TWO_SIDED|95.0|0.07|2.57|||ANCOVA|||||2.57|0.07|0.039
91490487|NCT02478632|182853505|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.016|TWO_SIDED|95.0|0.02|0.16||p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores|||0.16|0.02|0.016
91490488|NCT02478632|182853505|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.15||p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.|||0.15|0.01|0.026
91490489|NCT02478632|182853505|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.049|TWO_SIDED|95.0|0.0|0.23||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.|||0.23|0.00|0.049
91490490|NCT02478632|182853505|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.013|TWO_SIDED|95.0|0.03|0.27||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.|||0.27|0.03|0.013
91490491|NCT02478632|182853508|OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|95.0|-3.51|4.81|||||The analysis refers to INSTI and total hip.|||4.81|-3.51|
91490492|NCT02478632|182853508|OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|0.39|2.81|||||The analysis refers to NNRTI and total hip.|||2.81|0.39|
91490493|NCT02478632|182853508|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-1.39|3.38|||||this analysis refers to PI and total hip|||3.38|-1.39|
91490494|NCT02478632|182853508|OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|0.67|7.03|||||this analysis refers to INSTI and lumbar spine.|||7.03|0.67|
91490495|NCT02478632|182853508|OTHER||Mean Difference (Final Values)|1.25|||||TWO_SIDED|95.0|-0.26|2.76|||||this analysis refers to NNRTI and lumbar spine|||2.76|-0.26|
91490496|NCT02478632|182853508|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-3.0|3.77|||||this analysis refers to PI and lumbar spine|||3.77|-3.00|
91726877|NCT03203512|183348648|SUPERIORITY||||||=|0.014||||||Treatment: p=0.014; period: p=0.842; treatment x period interaction: p=0.943|ANOVA|||Null hypothesis is that there was no difference in change of plasma LDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma LDL-C.||||=0.014
91726878|NCT03203512|183348648|SUPERIORITY||||||=|0.077||||||Treatment: p=0.077; period: p=0.921; treatment x period interaction: p=0.793|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC.||||=0.077
91726879|NCT03203512|183348648|SUPERIORITY||||||=|0.379||||||Treatment: p=0.379; period: p=0.938; treatment x period interaction: p=0.341|ANOVA|||Null hypothesis is that there was no difference in change of plasma HDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma HDL-C.||||=0.379
91726880|NCT03203512|183348649|SUPERIORITY||||||=|0.285||||||Treatment: p=0.285; period: p=0.954; treatment x period interaction: p=0.528|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC/HDL-C ratio between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC/HDL-C ratio.||||=0.285
91726881|NCT03203512|183348650|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period effect: p=0.011; treatment x period interaction: p=0.033|ANOVA|||Null hypothesis is that there was no difference in change of SBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on SBP.||||<0.001
91726882|NCT03203512|183348650|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.952; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DBP.||||=0.002
91726883|NCT04098302|183348663|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
91726884|NCT04098302|183348664|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|||||||0.019
91726885|NCT04098302|183348665|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91726886|NCT04098302|183348666|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
91726887|NCT05061706|183348667|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-6.03|-3.02|||Mixed Effects Model for Repeated Measure|||||-3.02|-6.03|<0.0001
91726888|NCT05061706|183348668|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.33|||Mixed Effects Model for Repeated Measure|||||-0.33|-0.72|<0.0001
91726889|NCT00191152|183348669|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
91726890|NCT00191152|183348670|SUPERIORITY_OR_OTHER|||||||0.361||95.0|||||Log Rank|||||||0.361
91726891|NCT00191152|183348671|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
91726892|NCT00191152|183348672|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Log Rank|||||||0.385
91726893|NCT00191152|183348673|SUPERIORITY_OR_OTHER|||||||0.377||95.0|||||Log Rank|||||||0.377
91726894|NCT00191152|183348674|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Log Rank|||||||0.446
91726895|NCT00191152|183348675|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Log Rank|||||||0.785
91726896|NCT00191152|183348676|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Fisher Exact|||||||0.364
91726897|NCT00191152|183348677|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||||||0.446
91726898|NCT00191152|183348678|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Mixed Models Analysis|||||||0.990
91726899|NCT00191152|183348679|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Mixed Models Analysis|||||||0.117
91726900|NCT00191152|183348680|SUPERIORITY_OR_OTHER|||||||0.801||95.0|||||Mixed Models Analysis|||||||0.801
91726901|NCT00191152|183348681|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Mixed Models Analysis|||||||0.190
91726902|NCT00114777|183348682|SUPERIORITY_OR_OTHER||Treament Difference|1.1|||||TWO_SIDED|97.3|-7.2|9.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||9.4|-7.2|
91726903|NCT00114777|183348682|SUPERIORITY_OR_OTHER||Treatment difference|3.2|||||TWO_SIDED|97.3|-5.0|11.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||11.4|-5.0|
91726904|NCT00114777|183348683|SUPERIORITY_OR_OTHER||Percentage difference|-14.4||||0.0018|TWO_SIDED|97.3|-24.0|-4.7|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||-4.7|-24|0.0018
91726905|NCT00114777|183348683|SUPERIORITY_OR_OTHER||Percentage difference|-8.5||||0.0616|TWO_SIDED|97.3|-18.0|0.9|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||0.9|-18|0.0616
91490497|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.26|0.3|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.|||0.30|-0.26|
91490498|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|0.03|0.19|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.|||0.19|0.03|
91490499|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.09|0.24|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.|||0.24|-0.09|
91490500|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.25|0.37|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.|||0.37|-0.25|
91490501|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|0.02|0.18|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.|||0.18|0.02|
91490502|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.14|0.21|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.|||0.21|-0.14|
91490503|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|0.01|0.71|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.|||0.71|0.01|
91726906|NCT01181128|183348719|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.13|||negative binomial model|||The null hypothesis for the primary endpoint is no difference between the individualized (tailored) prophylaxis regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 90% power at the 2-sided 0.05 level of significance to detect a 60% reduction in annualized bleeding episodes, based upon this hypothesis test.||0.13|0.05|<0.001
91726907|NCT01181128|183348725|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||negative binomial model|||||0.46|0.12|<0.001
91726908|NCT04477486|183348758|SUPERIORITY|Comparing against a historical reference of 12.5% CRR.|||||<|0.001|||||||Exact Binomial Distribution|||||||<0.001
91726909|NCT01543503|183348772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.851|||<|0.001|TWO_SIDED|95.0|-1.112|-0.589|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.589|-1.112|<0.001
91726910|NCT01543503|183348773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||<|0.001|TWO_SIDED|95.0|-1.204|-0.617|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an ANCOVA model with change from baseline to 12 months in DAS28-ESR as dependent variable; therapy and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.617|-1.204|<0.001
91726911|NCT01543503|183348774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.23|||<|0.001|TWO_SIDED|95.0|-15.513|-10.947|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in ESR as a dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-10.947|-15.513|<0.001
91726912|NCT01543503|183348774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.648|||<|0.001|TWO_SIDED|95.0|-15.419|-9.876|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in ESR, as the dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-9.876|-15.419|<0.001
91726913|NCT01543503|183348775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.673|||<|0.001|TWO_SIDED|95.0|-10.271|-3.074|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CRP as a dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||-3.074|-10.271|<0.001
91726914|NCT01543503|183348775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.116||||0.659|TWO_SIDED|95.0|-6.074|3.842|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CRP as the dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||3.842|-6.074|0.659
91726915|NCT01543503|183348776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.024|TWO_SIDED|95.0|-1.078|-0.075|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SJC as the dependent variable; therapy and treatment as fixed effects; SJC at baseline as the covariate.||-0.075|-1.078|0.024
91726916|NCT01543503|183348776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.752||||0.002|TWO_SIDED|95.0|-1.238|-0.267|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SJC, as the dependent variable; therapy and treatment as fixed effects; SJC, at baseline as the covariate.||-0.267|-1.238|0.002
91726917|NCT01543503|183348777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.123|TWO_SIDED|95.0|-1.408|0.169|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||0.169|-1.408|0.123
91490504|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.|||0.25|-0.03|
91490505|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.3|0.33|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.|||0.33|-0.30|
91696177|NCT03521115|183286701|SUPERIORITY||F|0.85|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
91696178|NCT03521115|183286702|SUPERIORITY||b|-0.22|||<|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
91696179|NCT03521115|183286702|SUPERIORITY||b|-0.24|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
91696180|NCT03521115|183286702|SUPERIORITY||F|0.43|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
91696181|NCT03521115|183286703|SUPERIORITY||b|-0.16|||<|0.1|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.10
91696182|NCT03521115|183286703|SUPERIORITY||b|-0.26|||<|0.05|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
91696183|NCT03521115|183286703|SUPERIORITY||F|1.55|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
91696184|NCT03521115|183286704|SUPERIORITY||b|-0.35|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
91726918|NCT01543503|183348777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.216||||0.004|TWO_SIDED|95.0|-2.039|-0.393|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||-0.393|-2.039|0.004
91726919|NCT01543503|183348778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.475|||<|0.001|TWO_SIDED|95.0|-5.481|-1.469|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CDAI the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-1.469|-5.481|<0.001
91726920|NCT01543503|183348778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6|||<|0.001|TWO_SIDED|95.0|-6.708|-2.492|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CDAI as the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-2.492|-6.708|<0.001
91726921|NCT01543503|183348778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.229||||0.014|TWO_SIDED|95.0|-5.806|-0.652|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.652|-5.806|0.014
91726922|NCT01543503|183348778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.245||||0.027|TWO_SIDED|95.0|-6.121|-0.37|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.370|-6.121|0.027
91726923|NCT01543503|183348779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.03|||<|0.001|TWO_SIDED|95.0|-12.655|-5.404|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-5.404|-12.655|<0.001
91726924|NCT01543503|183348779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.237|||<|0.001|TWO_SIDED|95.0|-14.13|-6.345|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-6.345|-14.130|<0.001
91726925|NCT01543503|183348783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
91726926|NCT01543503|183348787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.02|TWO_SIDED|95.0|-0.269|-0.024|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.024|-0.269|0.020
91726927|NCT01543503|183348787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.02|TWO_SIDED|95.0|-0.301|-0.026|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.026|-0.301|0.020
91726928|NCT01543503|183348788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.893||||0.032|TWO_SIDED|95.0|-7.457|-0.329|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||-0.329|-7.457|0.032
91726929|NCT01543503|183348788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.787||||0.168|TWO_SIDED|95.0|-6.763|1.189|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||1.189|-6.763|0.168
91726930|NCT01543503|183348789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.661||||0.009|TWO_SIDED|95.0|-9.912|-1.411|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-1.411|-9.912|0.009
91726931|NCT01543503|183348789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.802|||<|0.001|TWO_SIDED|95.0|-14.245|-5.36|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-5.360|-14.245|<0.001
91726932|NCT01543503|183348791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.108||||0.01|TWO_SIDED|95.0|-9.017|-1.2|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-1.200|-9.017|0.010
91726933|NCT01543503|183348791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.767|||<|0.001|TWO_SIDED|95.0|-12.161|-3.372|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-3.372|-12.161|<0.001
91490506|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|0.03|0.74|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.|||0.74|0.03|
91490507|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.02|0.26|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.|||0.26|-0.02|
91726934|NCT00514917|183348837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0501|TWO_SIDED|95.0|1.0|1.65||A priori threshold for statistical significance = 0.05|Log Rank|P-value was not adjusted for multiplicity of tests.|The hazard ratio Leuprolide+Bicalutamide vs. Docetaxel+Leuprolide+Bicalutamide was estimated using an un-stratified Cox proportional hazards model. A hazard ratio \>1 indicates a lower risk of Docetaxel+Leuprolide, compared to Leuprolide.|"Null hypothesis: No difference between new treatment combination (Docetaxel+Leuprolide+Bicalutamide) and conventional treatment (Leuprolide+Bicalutamide).~The study was sized to have 90% power to detect a difference between treatment arms at a 2-sided 0.05 significance level with 186 events and anticipating 10% non-evaluable participants."||1.65|1.00|0.0501
91726935|NCT01666314|183348857|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED||||||Fisher Exact|||||||0.1078
91726936|NCT01666314|183348858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.145||||0.0355|TWO_SIDED|95.0|0.9895|18.7606|||Fisher Exact||Odds ratio \>1 favors orteronel.|||18.7606|0.9895|0.0355
91726937|NCT04739709|183348914|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726938|NCT04739709|183348915|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726939|NCT04739709|183348917|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726940|NCT04739709|183348918|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726941|NCT04739709|183348919|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726942|NCT04739709|183348920|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726943|NCT04739709|183348921|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726944|NCT04739709|183348922|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726945|NCT04739709|183348923|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726946|NCT04739709|183348924|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726947|NCT04739709|183348925|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-1.8|-1.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.3|-1.8|<0.001
91726948|NCT04739709|183348926|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.6|-0.9|<0.001
91726949|NCT04739709|183348927|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.5|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.5|-0.8|<0.001
91726950|NCT04739709|183348928|SUPERIORITY||Mean Difference (Net)|-0.03||||0.017|TWO_SIDED|95.0|-0.06|-0.01|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.01|-0.06|0.017
91726951|NCT04739709|183348929|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.04|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.04|-0.10|<0.001
91726952|NCT04739709|183348930|SUPERIORITY||Mean Difference (Net)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.11|-0.06|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.06|-0.11|<0.001
91726953|NCT04739709|183348931|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91726954|NCT03403517|183349012|SUPERIORITY||Risk Ratio (RR)|0.859||||0.213|TWO_SIDED|95.0|0.682|1.082|||Fisher Exact|||||1.082|0.682|0.213
91726955|NCT03403517|183349016|SUPERIORITY||Risk Ratio (RR)|0.977|||>|0.999|TWO_SIDED|95.0|0.557|1.715|||Fisher Exact|||||1.715|0.557|>0.999
91726956|NCT03403517|183349017|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.160
91726957|NCT01245751|183349049|NON_INFERIORITY_OR_EQUIVALENCE|Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is \>0.67|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.97|1.15||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||Week 6 analysis||1.15|0.97|<0.001
91726958|NCT01245751|183349050|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.54|||<|0.001|TWO_SIDED|95.0|1.44|1.66||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age||A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is \>1.0.||1.66|1.44|<0.001
91726959|NCT02391584|183349095|SUPERIORITY||||||<|0.0001||||||p\<0.025 was considered significant.|t-test, 1 sided|||||||<0.0001
91726960|NCT02391584|183349099|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
91726961|NCT02391584|183349100|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
91726962|NCT02391584|183349101|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
91726963|NCT02391584|183349102|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
91726964|NCT01301001|183349104|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.0|-0.7|0.07
91726965|NCT01301001|183349105|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.76|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||||0.6|-0.9|0.76
91726966|NCT01301001|183349106|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.36|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||||0.2|-0.5|0.36
91726967|NCT03992482|183349120|OTHER|||||||1|||||||Kruskal-Wallis|||||||1.000
91726968|NCT03992482|183349121|OTHER|||||||0.0044|||||||Mixed Models Analysis|||||||0.0044
91726969|NCT03992482|183349122|OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
91726970|NCT03636269|183349123|SUPERIORITY||Odds Ratio (OR)|1.61||||0.02|TWO_SIDED|95.0|1.08|2.41|||Cui, Hung, Wang|||||2.41|1.08|0.020
91726971|NCT03636269|183349124|SUPERIORITY||Odds Ratio (OR)|1.77||||0.01|TWO_SIDED|95.0|1.14|2.74|||Cui, Hung, Wang|||||2.74|1.14|0.010
91726972|NCT03636269|183349125|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.29||0.171|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|||||0.8|-4.3|0.171
91726973|NCT03636269|183349126|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.002|TWO_SIDED|95.0|-1.7|-0.4|||ANCOVA|||||-0.4|-1.7|0.002
91726974|NCT04250363|183349152|OTHER||Odds Ratio (OR)|3.57||||0.00284|TWO_SIDED|95.0|1.85|10.6|||Regression, Logistic|||||10.6|1.85|0.00284
91726975|NCT04250363|183349152|OTHER||Odds Ratio (OR)|4.19||||0.00367|TWO_SIDED|95.0|2.0|14.8|||Regression, Logistic|||||14.8|2.00|0.00367
91726976|NCT04250363|183349152|OTHER||Odds Ratio (OR)|4.22||||0.0137|TWO_SIDED|95.0|1.9|23.7|||Regression, Logistic|||||23.7|1.90|0.0137
91726977|NCT04250363|183349152|OTHER||Odds Ratio (OR)|2.23||||0.00349|TWO_SIDED|95.0|1.47|4.48|||Regression, Logistic|||||4.48|1.47|0.00349
91726978|NCT04250363|183349152|OTHER||Odds Ratio (OR)|11.6||||0.00594|TWO_SIDED|95.0|3.19|129.0|||Regression, Logistic|||||129|3.19|0.00594
91726979|NCT01507103|183349153|SUPERIORITY_OR_OTHER||Effect estimate|-0.04||||0.794|TWO_SIDED|95.0|-0.72|0.65||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.65|-0.72|0.794
91726980|NCT01507103|183349153|SUPERIORITY_OR_OTHER||Effect estimate|-0.2||||0.794|TWO_SIDED|95.0|-0.82|0.43||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.43|-0.82|0.794
91726981|NCT01507103|183349153|SUPERIORITY_OR_OTHER||Effect estimate|0.16||||0.794|TWO_SIDED|95.0|-0.49|0.82||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.82|-0.49|0.794
91726982|NCT01507103|183349153|SUPERIORITY_OR_OTHER||Effect estimate|0.02||||0.654|TWO_SIDED|95.0|-0.52|0.57||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.57|-0.52|0.654
91726983|NCT01507103|183349153|SUPERIORITY_OR_OTHER||Effect estimate|-0.19||||0.654|TWO_SIDED|95.0|-0.69|0.31||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.31|-0.69|0.654
91696185|NCT03521115|183286704|SUPERIORITY||b|-0.02|||>|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
91490508|NCT02478632|182853509|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.|||0.34|-0.26|
91696186|NCT03521115|183286705|SUPERIORITY||b|0.299|||<|0.01|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
91696187|NCT03521115|183286706|SUPERIORITY||b|0.268|||<|0.03|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.03
91696188|NCT03521115|183286707|SUPERIORITY||b|0.075|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
91696189|NCT03521115|183286708|SUPERIORITY||b|0.051|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
91696190|NCT03521115|183286709|SUPERIORITY||b|0.72|||<|0.05|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
91696191|NCT03521115|183286710|SUPERIORITY||||||>|0.1|||||||Chi-squared|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
91696192|NCT01080118|183286723|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.05||||0.001|TWO_SIDED|99.0|0.05|0.05|||t-test, 2 sided|||||.05|.05|.001
91696193|NCT01080118|183286723|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.001||95.0|||||t-test, 2 sided|||||||.001
91696194|NCT00839527|183286729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.68|||ANCOVA|||||-0.68|-1.07|<0.0001
91726984|NCT01507103|183349153|SUPERIORITY_OR_OTHER||Effect estimate|0.21||||0.654|TWO_SIDED|95.0|-0.31|0.74||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.74|-0.31|0.654
91726985|NCT01507103|183349154|SUPERIORITY_OR_OTHER||LS Means estimate|-0.03||||0.921|TWO_SIDED|95.0|-0.73|0.67|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.67|-0.73|0.921
91760025|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.67|-0.27||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.27|-0.67|
91490509|NCT01867424|182853514|OTHER||Median of Differences|0.43||||0.0008|TWO_SIDED|||||Median of difference in CER: All cases.|Wilcoxon Test||The relative difference between groups is based on the change from baseline values to the values collected at each of the three time points.|Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) in prostate cancers upon injection of Eovist. Subgroup analysis of CER in (i) Advanced Disease and (ii) Localized Disease||||0.0008
91726986|NCT01507103|183349154|SUPERIORITY_OR_OTHER||LS Means estimate|-0.2||||0.921|TWO_SIDED|95.0|-0.83|0.44|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.44|-0.83|0.921
91726987|NCT01507103|183349154|SUPERIORITY_OR_OTHER||LS Means estimate|0.17||||0.921|TWO_SIDED|95.0|-0.5|0.83|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.83|-0.50|0.921
91726988|NCT01507103|183349154|SUPERIORITY_OR_OTHER||LS Means estimate|0.02||||0.89|TWO_SIDED|95.0|-0.54|0.58|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.58|-0.54|0.890
91726989|NCT01507103|183349154|SUPERIORITY_OR_OTHER||LS Means estimate|-0.19||||0.89|TWO_SIDED|95.0|-0.7|0.31|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.31|-0.70|0.890
91726990|NCT01507103|183349154|SUPERIORITY_OR_OTHER||LS Means estimate|0.21||||0.89|TWO_SIDED|95.0|-0.32|0.74|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.74|-0.32|0.890
91490510|NCT01867424|182853514|OTHER||Median of Differences|0.42||||0.0039|TWO_SIDED|||||Median of difference in CER: Advanced Disease Cases.|Wilcoxon Test|||||||0.0039
91726991|NCT05075772|183349165|OTHER||Ratio of gMeans (%)|46.3|||||TWO_SIDED|90.0|38.3|55.9|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=28.2."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||55.9|38.3|
91726992|NCT05075772|183349166|OTHER||Ratio of gMeans (%)|26.8|||||TWO_SIDED|90.0|23.2|31.1|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)). Intra-matched-pair geometric coefficient of variation=22.5"|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||31.1|23.2|
91490511|NCT01867424|182853514|OTHER||Median of Differences|0.475||||0.084|TWO_SIDED|||||Median of difference in CER: Local Disease Cases.|Wilcoxon Test|||||||0.084
91490512|NCT01867424|182853514|OTHER||Median Difference CER|0.17||||0.25|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.25
91490513|NCT01867424|182853514|OTHER||Median Difference CER|0.27||||0.1602|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.1602
91726993|NCT05075772|183349167|OTHER||Ratio of gMeans (%)|47.0|||||TWO_SIDED|90.0|39.0|56.6|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=27.7."|The statistical model used for the analysis of this secondary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||56.6|39.0|
91726994|NCT00927186|183349175|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The pre-specified significance level 0.05 was used.|Wilcoxon (Mann-Whitney)|||||||<0.001
91726995|NCT00927186|183349176|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91726996|NCT00927186|183349177|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91726997|NCT00927186|183349177|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
91490514|NCT01867424|182853514|OTHER||Median Difference CER|0.29||||0.0078|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.0078
91490515|NCT01867424|182853514|OTHER||Median Difference CER|0.34||||0.0039|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.0039
91528231|NCT01370005|182931723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.51|-0.93||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.93|-2.51|<0.0001
91726998|NCT00927186|183349178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91726999|NCT00927186|183349178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727000|NCT00927186|183349179|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
91727001|NCT00927186|183349179|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
91490516|NCT01867424|182853514|OTHER||Median Difference CER|0.27||||0.0046|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection; Total cases.||||0.0046
91528232|NCT01370005|182931724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.0001|TWO_SIDED|95.0|3.51|11.18|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.18|3.51|<0.0001
91727002|NCT00927186|183349180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727003|NCT00927186|183349180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727004|NCT00927186|183349180|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
91727005|NCT00927186|183349180|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
91490517|NCT01867424|182853514|OTHER||Median Difference CER|0.33||||0.0017|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection; Total cases.||||0.0017
91727006|NCT00927186|183349181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727007|NCT00927186|183349181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727008|NCT00927186|183349182|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
91727009|NCT00927186|183349182|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
91727010|NCT00927186|183349183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727011|NCT00927186|183349183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727012|NCT00927186|183349183|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
91727013|NCT00927186|183349183|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
91727014|NCT00927186|183349184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727015|NCT00927186|183349184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727016|NCT00927186|183349185|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.020
91727017|NCT00927186|183349185|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.005
91696195|NCT00839527|183286729|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Mean Difference (Net)|0.25||||0.2685|TWO_SIDED|95.0|0.1|0.4|||t-test, 1 sided|||||0.40|0.10|0.2685
91490518|NCT01867424|182853516|OTHER||Spearman r|-0.137||||0.5761|TWO_SIDED|95.0|-0.5665|0.3511|||Nonparametric Spearman correlation|The calculation of Spearman correlation is between baseline PSA and CER at 20 minutes post Eovist injection.||Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) with Eovist injection based on baseline Prostate-specific antigen (PSA) levels at 20-minute timepoint.||0.3511|-0.5665|0.5761
91528233|NCT01370005|182931724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.7|11.75|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.75|3.70|<0.0001
91696196|NCT02295020|183286738|SUPERIORITY_OR_OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
91696197|NCT02295020|183286739|SUPERIORITY_OR_OTHER|||||||0.232|||||||t-test, 2 sided|||||||0.232
91696198|NCT02295020|183286740|SUPERIORITY_OR_OTHER|||||||0.311|||||||t-test, 2 sided|||||||0.311
91696199|NCT02295020|183286742|SUPERIORITY_OR_OTHER|||||||0.449|||||||t-test, 2 sided|||||||0.449
91696200|NCT02295020|183286743|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
91696201|NCT02295020|183286744|SUPERIORITY_OR_OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
91696202|NCT02295020|183286745|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.479
91696203|NCT02295020|183286746|SUPERIORITY_OR_OTHER|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
91696204|NCT02295020|183286747|SUPERIORITY_OR_OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
91490519|NCT01867424|182853516|OTHER||Spearman r|-0.257||||0.3033|TWO_SIDED|95.0|-0.6549|0.2526|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 40 minutes post Eovist injection.||0.2526|-0.6549|0.3033
91696205|NCT02751450|183286751|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.882|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.882|-1.150|<0.0001
91696206|NCT00943150|183286769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
91696207|NCT00943150|183286770|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANOVA|||CD3+ at 0 weeks||||0.33
91696208|NCT00943150|183286770|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||CD3+ at 3 weeks||||0.02
91696209|NCT00943150|183286770|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||CD3+ at 6 weeks||||0.71
91696210|NCT00943150|183286770|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||CD68+ at 0 weeks||||0.67
91696211|NCT00943150|183286770|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||CD68+ at 3 weeks||||0.01
91696212|NCT00943150|183286770|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|||CD68+ at 6 weeks||||0.48
91696213|NCT00943150|183286771|SUPERIORITY_OR_OTHER|||||||0.1128||95.0|||||Exact Wilcoxon rank-sum test|||||||0.1128
91696214|NCT00943150|183286772|SUPERIORITY_OR_OTHER|||||||0.0898||95.0|||||Exact Wilcoxon test|||||||0.0898
91696215|NCT00943150|183286773|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||Exact Wilcoxon test|||Intraoperative narcotic use comparison||||0.0760
91696216|NCT00943150|183286773|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Exact Wilcoxon test|||Postoperative narcotic use comparison||||0.5900
91696217|NCT00943150|183286774|SUPERIORITY_OR_OTHER|||||||0.4589||95.0|||||Exact Wilcoxon test|||||||0.4589
91696218|NCT00943150|183286775|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Exact Wilcoxon test|||||||0.999
91696219|NCT00943150|183286776|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||Exact Wilcoxon test|||||||0.0412
91696220|NCT00937040|183286807|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject.|ANCOVA|P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16.||Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made.||||<0.001
91696221|NCT00937040|183286808|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#02.||||0.206
91696222|NCT00937040|183286809|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#03.||||0.348
91696223|NCT00937040|183286810|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#04.||||0.324
91696224|NCT00937040|183286811|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#05.||||0.631
91727018|NCT00927186|183349186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91490520|NCT01867424|182853516|OTHER||Spearman r|-0.2861||||0.2351|TWO_SIDED|95.0|-0.6634|0.2071|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 60 minutes post Eovist injection.||0.2071|-0.6634|0.2351
91696225|NCT00937040|183286812|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#06.||||<0.001
91696226|NCT00937040|183286813|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#07.||||<0.001
91696227|NCT00937040|183286814|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#08.||||0.008
91696228|NCT00937040|183286815|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#09.||||0.372
91696229|NCT00937040|183286816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#10.||||<0.001
91696230|NCT00937040|183286817|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined using CMH general association controlling for pooled center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#11.||||0.008
91696231|NCT00937040|183286818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#12.||||<0.001
91696232|NCT00937040|183286819|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#13.||||0.003
91696233|NCT00937040|183286820|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#14.||||0.016
91696234|NCT00937040|183286821|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#15.||||0.092
91696235|NCT00937040|183286822|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center. Missing/unknown responses are not included in the p-value.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#16.||||0.284
91727019|NCT00927186|183349186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91696236|NCT00937040|183286823|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||<0.001
91490521|NCT01867424|182853516|OTHER||Median Difference (actual)|-0.47||||0.111|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.111
91696237|NCT00937040|183286824|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.319
91696238|NCT00937040|183286825|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.007
91696239|NCT02477826|183286826|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||||0.93|0.67|
91696240|NCT02477826|183286826|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||||1.12|0.81|
91696241|NCT02477826|183286826|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
91696242|NCT02477826|183286826|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
91727020|NCT00927186|183349186|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
91727021|NCT00927186|183349186|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.025
91727022|NCT00927186|183349187|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727023|NCT00927186|183349187|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91696243|NCT02477826|183286826|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.59|0.93||||||||0.93|0.59|
91696244|NCT02477826|183286826|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.52|0.72||||||||0.72|0.52|
91696245|NCT02477826|183286826|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.89||||||||0.89|0.49|
91696246|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.67|0.91||||||||0.91|0.67|
91696247|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.78|1.05||||||||1.05|0.78|
91696248|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|1.01||||||||1.01|0.74|
91696249|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.51|0.79||||||||0.79|0.51|
91696250|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.63|0.96||||||||0.96|0.63|
91696251|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.64|0.87||||||||0.87|0.64|
91727024|NCT00927186|183349188|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.050
91696252|NCT02477826|183286827|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.64|1.14||||||||1.14|0.64|
91727025|NCT00927186|183349188|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.016
91727026|NCT00927186|183349189|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727027|NCT00927186|183349189|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727028|NCT00927186|183349189|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
91727029|NCT00927186|183349189|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
91727030|NCT00927186|183349190|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727031|NCT00927186|183349190|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91696253|NCT01342523|183286833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.825|TWO_SIDED|95.0|0.88|1.17||P-value is not adjusted for multiple comparisons.|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.||1.17|0.88|.825
91727032|NCT00927186|183349191|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
91727033|NCT00927186|183349191|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
91696254|NCT01342523|183286833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.028|TWO_SIDED|95.0|1.02|1.36||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.||1.36|1.02|.028
91727034|NCT00927186|183349192|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.049
91727035|NCT00927186|183349192|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727036|NCT00927186|183349192|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
91727037|NCT00927186|183349192|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.196
91727038|NCT00927186|183349193|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.502
91727039|NCT00927186|183349193|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.597
91727040|NCT00927186|183349194|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.077
91727041|NCT00927186|183349194|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.358
91727042|NCT00927186|183349195|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.647
91727043|NCT00927186|183349195|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.120
91727044|NCT00927186|183349195|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
91727045|NCT00927186|183349195|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||1.00
91727046|NCT00927186|183349196|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727047|NCT00927186|183349196|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
91727048|NCT00927186|183349197|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||1.00
91490522|NCT01867424|182853516|OTHER||Median Difference (actual)|-0.775||||0.7738|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.7738
91727049|NCT00927186|183349197|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.198
91727050|NCT00927186|183349198|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.022
91727051|NCT00927186|183349198|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727052|NCT00927186|183349198|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
91727053|NCT00927186|183349198|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.139
91727054|NCT00927186|183349199|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.154
91727055|NCT00927186|183349199|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.052
91727056|NCT00927186|183349200|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
91727057|NCT00927186|183349200|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
91727058|NCT00927186|183349201|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.979
91696255|NCT01342523|183286833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.755|TWO_SIDED|95.0|0.85|1.13||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.||1.13|0.85|.755
91727059|NCT00927186|183349201|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.002
91727060|NCT00927186|183349201|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
91727061|NCT00927186|183349201|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.853
91727062|NCT00927186|183349202|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727063|NCT00927186|183349202|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727064|NCT00927186|183349203|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.006
91727065|NCT00927186|183349203|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.001
91727066|NCT00927186|183349204|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727067|NCT00927186|183349204|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727068|NCT00927186|183349204|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for sLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.004
91727069|NCT00927186|183349204|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for dLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
91727070|NCT00927186|183349205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||<0.001
91727071|NCT00927186|183349206|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||0.033
91727072|NCT00927186|183349207|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 6 months."|Fisher Exact|||||||<0.001
91727073|NCT00927186|183349207|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 24 months."|Fisher Exact|||||||0.009
91727074|NCT00927186|183349208|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91727075|NCT00927186|183349209|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.906
91727076|NCT00927186|183349210|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.536
91727077|NCT00927186|183349210|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.896
91727078|NCT00927186|183349211|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91727079|NCT00927186|183349212|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91727080|NCT00927186|183349213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91727081|NCT00927186|183349214|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.008
91727082|NCT00927186|183349215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727083|NCT00927186|183349215|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
91727084|NCT00927186|183349216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91696256|NCT01342523|183286833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.057|TWO_SIDED|95.0|0.996|1.33||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .||1.33|0.996|.057
91696257|NCT01342523|183286833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.555||95.0|0.83|1.11||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.||1.11|0.83|.555
91727085|NCT00927186|183349217|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
91727086|NCT00927186|183349218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91727087|NCT00927186|183349218|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
91727088|NCT00927186|183349219|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
91727089|NCT00927186|183349220|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
91727090|NCT00927186|183349221|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.027
91696258|NCT00305084|183286845|OTHER||MDT|1.6|||||TWO_SIDED|||||||||All data regarding safety were registered and analyzed by descriptive analyses. Summary table were generated to document the safety|at least 3 patients per cohort had to be enrolled with expansion to 6 in presence of Dose Limiting Toxicity(DLT) (stop escalation if 2 or more DLTs at the same dose level). With a projection to achieve the highest level of NGR-hTNF, without significative toxicity (1.6 μg/m2) a planned sample of 20-25 patients was expected. DLTs were defined as: any severe toxicity clearly related to the administration of NGR-hTNF. The patient was defined assessable, according to the standard analysis, if he/she received at least one infusion of the investigational product. Maximal Tollerated Dose (MTD) was defined as the dose which produces DLTs in 2 or more patients out of 6 and will be recommended for phase II trials.|||
91727091|NCT00927186|183349221|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.268
91727092|NCT00927186|183349222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91727093|NCT00927186|183349223|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.025
91727094|NCT00927186|183349224|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.012
91727095|NCT00927186|183349224|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.092
91727096|NCT00927186|183349225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
91727097|NCT00927186|183349225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
91727098|NCT00927186|183349225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
91727099|NCT00927186|183349226|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91727100|NCT00927186|183349227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
91727101|NCT00927186|183349227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
91727102|NCT00927186|183349227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
91727103|NCT00927186|183349228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91727104|NCT00927186|183349229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
91727105|NCT00927186|183349229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
91727106|NCT00927186|183349229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
91727107|NCT00927186|183349230|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91727108|NCT01145222|183349231|SUPERIORITY|Overall comparison between remimazolam and midazolam||||||0.007|||||||Fisher Exact|||||||0.007
91727109|NCT00604383|183349234|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.034
91727110|NCT01429623|183349301|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.16|TWO_SIDED|95.0|0.74|3.25|||Log Rank|||||3.25|0.74|<0.16
91727111|NCT01429623|183349302|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.24|<|0.61|TWO_SIDED||||||Mixed Models Analysis|||||||<0.61
91727112|NCT01429623|183349303|SUPERIORITY||Mean Difference (Net)|-0.066|STANDARD_ERROR_OF_MEAN|0.085|<|0.32|TWO_SIDED||||||Mixed Models Analysis|||||||<0.32
91727113|NCT01429623|183349304|SUPERIORITY||Mean Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|1.17|<|0.97|TWO_SIDED||||||Mixed Models Analysis|||||||<0.97
91490523|NCT04645953|182853518|SUPERIORITY|||||||0.7024|||||||ANOVA|||Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. All statistical tests were 2-sided with a significance value of ≤ 0.05.||||0.7024
91696259|NCT01218087|183286868|NON_INFERIORITY_OR_EQUIVALENCE|Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
91696260|NCT00529373|183286924|OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.4|0.53|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.53|0.40|<0.001
91727114|NCT00793611|183349319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.07|||||||t-test, 2 sided|19 degrees of freedom||ITT between group differences in change scores compared for behavioral therapy and hypnotherapy groups. Power analysis: This is a pilot study underpowered find between group differences based on our power analysis(a 20% difference between groups would require 88 women, assuming 80% power and α=0.05 based on Freeman's study cited later). The purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes||||.07
91490524|NCT04645953|182853518|SUPERIORITY|Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. Patients summarized by actual treatment received. Formal statistical tests (ANOVA, when performed) were 2-sided t-tests with a significance value of 0.05.||||||0.2051|||||||ANOVA|||||||0.2051
91696261|NCT00529373|183286925|OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.71|0.39|<0.001
91696262|NCT00529373|183286926|OTHER||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.87|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.87|0.68|<0.001
91696263|NCT00529373|183286927|OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.42|0.55|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.55|0.42|<0.001
91696264|NCT00529373|183286928|OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.67|0.40|<0.001
91696265|NCT00529373|183286929|OTHER||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.83|0.66|<0.001
91727115|NCT00793611|183349320|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||intent to treat.||||.17
91727116|NCT00793611|183349321|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||intent to treat||||.009
91490525|NCT04645953|182853519|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
91490526|NCT04645953|182853519|SUPERIORITY|Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
91696266|NCT00529373|183286930|OTHER|Miettinen \& Nurminen|Difference in rates|0.88|||||TWO_SIDED|95.0|-2.3|4.07||||||||4.07|-2.3|
91696267|NCT00529373|183286931|OTHER|Miettinen \& Nurminen|Difference in rates|0.11|||||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
91696268|NCT00529373|183286935|OTHER||Difference in Least Squares Means|8.92|||<|0.001|TWO_SIDED|95.0|3.9|13.93|||Longitudinal model|||Odanacatib 50 mg vs Placebo||13.93|3.9|<0.001
91696269|NCT00529373|183286936|OTHER||Difference in Least Squares Means|26.45|||<|0.001|TWO_SIDED|95.0|16.49|36.4|||Longitudinal model|||Odanacatib 50 mg vs Placebo||36.40|16.49|<0.001
91696270|NCT00529373|183286937|OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.14|0.09||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.14|
91696271|NCT00529373|183286937|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.12|0.12||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.12|-0.12|
91727117|NCT04299425|183349346|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91727118|NCT04299425|183349347|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91727119|NCT04299425|183349349|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91727120|NCT04299425|183349350|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
91727121|NCT00601107|183349426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||1|TWO_SIDED|95.0|0.17|4.22||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.22|0.17|1.000
91696272|NCT00529373|183286937|OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.17|0.09||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.17|
91696273|NCT00529373|183286937|OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|95.0|-0.5|0.08||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.08|-0.50|
91696274|NCT00529373|183286938|OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.16|0.38||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.38|-0.16|
91696275|NCT00529373|183286938|OTHER||Difference in Least Squares Means|0.14|||||TWO_SIDED|95.0|-0.15|0.44||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.44|-0.15|
91696276|NCT00529373|183286938|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.15|0.54||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.54|-0.15|
91696277|NCT00529373|183286938|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.24|0.62||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.62|-0.24|
91696278|NCT00529373|183286939|OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.08|0.15||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.15|-0.08|
91696279|NCT00529373|183286939|OTHER||Difference in Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.06|0.21||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.21|-0.06|
91696280|NCT00529373|183286939|OTHER||Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.12|0.17||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.17|-0.12|
91696281|NCT00529373|183286939|OTHER||Difference in Least Squares Means|0.09|||||TWO_SIDED|95.0|-0.09|0.28||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.28|-0.09|
91696282|NCT00529373|183286940|OTHER|Miettinen \& Nurminen|Difference in rates|1.52|||||TWO_SIDED|95.0|-1.8|4.84||||||||4.84|-1.8|
91490527|NCT04645953|182853520|SUPERIORITY|||||||0.8299||||||Prior Episode Duration 1mg AZ-010|Mixed Models Analysis|||||||0.8299
91696283|NCT00529373|183286941|OTHER|Miettinen \& Nurminen|Difference in rates|0.27|||||TWO_SIDED|95.0|-0.04|0.58||||||||0.58|-0.04|
91696284|NCT00529373|183286942|OTHER||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.4|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.40|0.19|<0.001
91696285|NCT00529373|183286943|OTHER||Difference in Least Squares Means|0.01||||0.041|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|||Odanacatib 50 mg OW versus Placebo. The mixed model contained fixed effects for treatment, region, stratum, treatment-year interaction and random effect intercept and slope (year) and unstructured covariance matrix.||0.03|0.00|0.041
91696286|NCT00529373|183286944|OTHER||Odds Ratio (OR)|0.89||||0.014|TWO_SIDED|95.0|0.81|0.98|||Logistic model|||Odanacatib 50 mg OW versus Placebo. Treatment comparison for height loss at any time during the treatment period. The logistic model contained terms for treatment, geographic region and stratum.||0.98|0.81|0.014
91696287|NCT00529373|183286945|OTHER||Difference in Least Squares Means|1.32|||<|0.001|TWO_SIDED|95.0|0.9|1.75|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.75|0.90|<0.001
91696288|NCT00529373|183286945|OTHER||Difference in Least Squares Means|2.49|||<|0.001|TWO_SIDED|95.0|2.37|2.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.61|2.37|<0.001
91696289|NCT00529373|183286945|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
91490528|NCT04645953|182853520|SUPERIORITY|||||||0.2346||||||Prior Episode Duration 3 mg AZ-010|Mixed Models Analysis|||||||0.2346
91490529|NCT04645953|182853520|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 1mg AZ-010|Mixed Models Analysis|||||||0.3997
91696290|NCT00529373|183286945|OTHER||Difference in Least Squares Means|6.44|||<|0.001|TWO_SIDED|95.0|6.25|6.64|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.64|6.25|<0.001
91696291|NCT00529373|183286945|OTHER||Difference in Least Squares Means|8.62|||<|0.001|TWO_SIDED|95.0|8.11|9.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.12|8.11|<0.001
91696292|NCT00529373|183286945|OTHER||Difference in Least Squares Means|9.49|||<|0.001|TWO_SIDED|95.0|8.7|10.29|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.29|8.70|<0.001
91696293|NCT00529373|183286946|OTHER||Difference in Least Squares Means|2.96|||<|0.001|TWO_SIDED|95.0|2.47|3.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.46|2.47|<0.001
91696294|NCT00529373|183286946|OTHER||Difference in Least Squares Means|4.07|||<|0.001|TWO_SIDED|95.0|3.93|4.22|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.22|3.93|<0.001
91696295|NCT00529373|183286946|OTHER||Difference in Least Squares Means|6.05|||<|0.001|TWO_SIDED|95.0|5.87|6.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.23|5.87|<0.001
91696296|NCT00529373|183286946|OTHER||Difference in Least Squares Means|7.84|||<|0.001|TWO_SIDED|95.0|7.62|8.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.06|7.62|<0.001
91696297|NCT00529373|183286946|OTHER||Difference in Least Squares Means|9.72|||<|0.001|TWO_SIDED|95.0|9.16|10.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.27|9.16|<0.001
91696298|NCT00529373|183286946|OTHER||Difference in Least Squares Means|11.23|||<|0.001|TWO_SIDED|95.0|10.23|12.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.23|10.23|<0.001
91696299|NCT00529373|183286947|OTHER||Difference in Least Squares Means|1.49|||<|0.001|TWO_SIDED|95.0|0.95|2.03|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.03|0.95|<0.001
91696300|NCT00529373|183286947|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
91696301|NCT00529373|183286947|OTHER||Difference in Least Squares Means|4.38|||<|0.001|TWO_SIDED|95.0|4.19|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.19|<0.001
91490530|NCT04645953|182853520|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 3mg AZ-010|Mixed Models Analysis|||||||0.3997
91696302|NCT00529373|183286947|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.24|6.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.68|6.24|<0.001
91696303|NCT00529373|183286947|OTHER||Difference in Least Squares Means|8.42|||<|0.001|TWO_SIDED|95.0|7.82|9.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.02|7.82|<0.001
91696304|NCT00529373|183286947|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|7.54|9.53|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.53|7.54|<0.001
91696305|NCT00529373|183286948|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.03|2.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.46|1.03|<0.001
91696306|NCT00529373|183286948|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
91696307|NCT00529373|183286948|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.17|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.17|<0.001
91696308|NCT00529373|183286948|OTHER||Difference in Least Squares Means|9.27|||<|0.001|TWO_SIDED|95.0|8.98|9.57|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 36||9.57|8.98|<0.001
91696309|NCT00529373|183286948|OTHER||Difference in Least Squares Means|12.44|||<|0.001|TWO_SIDED|95.0|11.66|13.22|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 48||13.22|11.66|<0.001
91490531|NCT04645953|182853521|SUPERIORITY|||||||0.3847|||||||Mantel Haenszel|||||||0.3847
91696310|NCT00529373|183286948|OTHER||Difference in Least Squares Means|13.81|||<|0.001|TWO_SIDED|95.0|12.58|15.04|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60||15.04|12.58|<0.001
91727122|NCT00601107|183349426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.992||95.0|0.13|4.14||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.14|0.13|0.992
91727123|NCT00601107|183349426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||1|TWO_SIDED|95.0|0.15|4.59||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.59|0.15|1.000
91727124|NCT00682838|183349434|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 1 sided|||||||0.50
91727125|NCT02864914|183349442|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.5|1.19|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.19|0.50|
91727126|NCT02864914|183349442|OTHER||Adjusted incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.23|1.32|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.32|0.23|
91727127|NCT02864914|183349442|OTHER||Adjusted incidence rate ratio|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.41|0.52|
91727128|NCT02864914|183349443|OTHER||Adjusted incidence rate ratio|0.54|||||TWO_SIDED|95.0|0.41|0.73|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.73|0.41|
91727129|NCT02864914|183349443|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.3|0.55|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.55|0.30|
91727130|NCT02864914|183349443|OTHER||Adjusted incidence rate ratio|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.05|0.45|
91727131|NCT02864914|183349443|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.2|0.86|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.86|0.20|
91727132|NCT02864914|183349443|OTHER||Adjusted incidence rate ratio|0.65|||||TWO_SIDED|95.0|0.56|0.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.76|0.56|
91727133|NCT02864914|183349444|OTHER||Adjusted incidence rate ratio|2.19|||||TWO_SIDED|95.0|1.74|2.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.76|1.74|
91490532|NCT04645953|182853521|SUPERIORITY|||||||0.1785|||||||Mantel Haenszel|||||||0.1785
91490533|NCT04645953|182853522|SUPERIORITY|||||||0.9732|||||||Mantel Haenszel|||||||0.9732
91490534|NCT04645953|182853522|SUPERIORITY|||||||0.1471|||||||Mantel Haenszel|||||||0.1471
91696311|NCT00529373|183286949|OTHER||Difference in Least Squares Means|1.11|||<|0.001|TWO_SIDED|95.0|0.67|1.55|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.55|0.67|<0.001
91696312|NCT00529373|183286949|OTHER||Difference in Least Squares Means|1.35|||<|0.001|TWO_SIDED|95.0|0.85|1.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.84|0.85|<0.001
91696313|NCT00529373|183286949|OTHER||Difference in Least Squares Means|1.93|||<|0.001|TWO_SIDED|95.0|1.38|2.47|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.47|1.38|<0.001
91727134|NCT02864914|183349444|OTHER||Adjusted incidence rate ratio|2.78|||||TWO_SIDED|95.0|1.77|4.36|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.36|1.77|
91727135|NCT02864914|183349444|OTHER||Adjusted incidence rate ratio|2.14|||||TWO_SIDED|95.0|1.11|4.12|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.12|1.11|
91727136|NCT02864914|183349444|OTHER||Adjusted incidence rate ratio|1.99|||||TWO_SIDED|95.0|1.48|2.66|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.66|1.48|
91727137|NCT02864914|183349445|OTHER||Adjusted incidence rate ratio|0.51|||||TWO_SIDED|95.0|0.37|0.72|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.72|0.37|
91727138|NCT02864914|183349446|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.46|4.71|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.71|3.46|
91727139|NCT02864914|183349447|OTHER||Adjusted incidence rate ratio|3.24|||||TWO_SIDED|95.0|2.81|3.74|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.74|2.81|
91696314|NCT00529373|183286949|OTHER||Difference in Least Squares Means|2.2||||0.001|TWO_SIDED|95.0|0.89|3.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.51|0.89|0.001
91727140|NCT02864914|183349448|OTHER||Adjusted incidence rate ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.88|0.56|
91727141|NCT02864914|183349448|OTHER||Adjusted incidence rate ratio|0.5|||||TWO_SIDED|95.0|0.29|0.85|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.85|0.29|
91490535|NCT04645953|182853523|SUPERIORITY|||||||0.1337|||||||ANOVA|||The RINVR is an 8-part questionnaire with each item scored from 0-4, for a total scoring range of 0-32. A lower score indicates less distress related to nausea, vomiting, and retching. The data shown is collected within the first 24 hours after the first at-home dose.||||0.1337
91696315|NCT00529373|183286949|OTHER||Difference in Least Squares Means|3.5||||0.001|TWO_SIDED|95.0|1.46|5.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||5.54|1.46|0.001
91696316|NCT00529373|183286950|OTHER||Difference in Least Squares Means|5.79|||<|0.001|TWO_SIDED|95.0|5.37|6.2|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.2|5.37|<0.001
91696317|NCT00529373|183286950|OTHER||Difference in Least Squares Means|4.02|||<|0.001|TWO_SIDED|95.0|3.67|4.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.37|3.67|<0.001
91696318|NCT00529373|183286950|OTHER||Difference in Least Squares Means|7.62|||<|0.001|TWO_SIDED|95.0|7.11|8.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.13|7.11|<0.001
91696319|NCT00529373|183286950|OTHER||Difference in Least Squares Means|9.51|||<|0.001|TWO_SIDED|95.0|7.96|11.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.06|7.96|<0.001
91696320|NCT00529373|183286951|OTHER||Difference in Least Squares Means|2.4|||<|0.001|TWO_SIDED|95.0|2.11|2.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.68|2.11|<0.001
91696321|NCT00529373|183286951|OTHER||Difference in Least Squares Means|4.21|||<|0.001|TWO_SIDED|95.0|3.84|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|3.84|<0.001
91696322|NCT00529373|183286951|OTHER||Difference in Least Squares Means|5.86|||<|0.001|TWO_SIDED|95.0|5.41|6.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.30|5.41|<0.001
91696323|NCT00529373|183286951|OTHER||Difference in Least Squares Means|8.54|||<|0.001|TWO_SIDED|95.0|7.0|10.09|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.09|7.00|<0.001
91696324|NCT00529373|183286952|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|1.83|2.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.59|1.83|<0.001
91696325|NCT00529373|183286952|OTHER||Difference in Least Squares Means|4.33|||<|0.001|TWO_SIDED|95.0|3.87|4.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.78|3.87|<0.001
91696326|NCT00529373|183286952|OTHER||Difference in Least Squares Means|6.09|||<|0.001|TWO_SIDED|95.0|5.56|6.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.62|5.56|<0.001
91696327|NCT00529373|183286952|OTHER||Difference in Least Squares Means|9.08|||<|0.001|TWO_SIDED|95.0|6.97|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|6.97|<0.001
91696328|NCT00529373|183286953|OTHER||Difference in Least Squares Means|3.44|||<|0.001|TWO_SIDED|95.0|2.98|3.9|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 12||3.90|2.98|<0.001
91490536|NCT04645953|182853523|SUPERIORITY|||||||0.7224|||||||ANOVA|||||||0.7224
91727142|NCT02864914|183349448|OTHER||Adjusted incidence rate ratio|0.66|||||TWO_SIDED|95.0|0.34|1.29|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.29|0.34|
91727143|NCT02864914|183349448|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.61|0.97|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.97|0.61|
91727144|NCT02864914|183349449|OTHER||Adjusted incidence rate ratio|0.53|||||TWO_SIDED|95.0|0.43|0.65|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.65|0.43|
91727145|NCT02864914|183349450|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.44|4.75|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.75|3.44|
91727146|NCT02864914|183349451|OTHER||Adjusted incidence rate ratio|3.34|||||TWO_SIDED|95.0|2.83|3.95|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.95|2.83|
91727147|NCT03501277|183349466|EQUIVALENCE|Alogliptin: For each analyte, an analysis of variance (ANOVA) was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative bioavailability (BA) determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90 percent (%) confidence interval (CI) for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|Least Square Mean (LSM) difference|1.0706||||0.014|TWO_SIDED|90.0|1.023|1.1204|||ANOVA|||||1.1204|1.0230|0.014
91727148|NCT03501277|183349466|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0276||||0.326|TWO_SIDED|90.0|0.9817|1.0757|||ANOVA|||||1.0757|0.9817|0.326
91727149|NCT03501277|183349466|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM diiference|0.9594||||0.405|TWO_SIDED|90.0|0.8837|1.0415|||ANOVA|||||1.0415|0.8837|0.405
91727150|NCT03501277|183349466|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|0.9257||||0.124|TWO_SIDED|90.0|0.8523|1.0053|||ANOVA|||||1.0053|0.8523|0.124
91727151|NCT03501277|183349467|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0157||||0.081|TWO_SIDED|90.0|1.0009|1.0308|||ANOVA|||||1.0308|1.0009|0.081
91727152|NCT03501277|183349467|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0009||||0.922|TWO_SIDED|90.0|0.9862|1.0158|||ANOVA|||||1.0158|0.9862|0.922
91727153|NCT03501277|183349467|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0486||||0.066|TWO_SIDED|90.0|1.0051|1.0939|||ANOVA|||||1.0939|1.0051|0.066
91727154|NCT03501277|183349467|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0267||||0.308|TWO_SIDED|90.0|0.9839|1.0714|||ANOVA|||||1.0714|0.9839|0.308
91727155|NCT00098293|183349514|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.0|||||ONE_SIDED|97.5|-9.5|||||||Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-9.5|
91528234|NCT01370005|182931725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.76|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|-28.91|-18.6|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo.|||-18.60|-28.91|<0.0001
91727156|NCT00098293|183349514|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.2|||||ONE_SIDED|97.5|-10.9|||||||Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.9|
91696329|NCT00529373|183286953|OTHER||Difference in Least Squares Means|6.03|||<|0.001|TWO_SIDED|95.0|5.47|6.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.59|5.47|<0.001
91727157|NCT00098293|183349515|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.1|||||ONE_SIDED|97.5|-10.5|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.5|
91490537|NCT04645953|182853524|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their abdominal pain, nausea, and anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
91490538|NCT04645953|182853524|SUPERIORITY|||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
91490539|NCT04645953|182853525|SUPERIORITY|||||||0.9664|||||||Mixed Models Analysis|||||||0.9664
91696330|NCT00529373|183286953|OTHER||Difference in Least Squares Means|8.49|||<|0.001|TWO_SIDED|95.0|7.81|9.16|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.16|7.81|<0.001
91696331|NCT00529373|183286953|OTHER||Difference in Least Squares Means|11.76|||<|0.001|TWO_SIDED|95.0|9.15|14.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||14.36|9.15|<0.001
91727158|NCT00098293|183349515|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.4|||||ONE_SIDED|97.5|-11.2|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-11.2|
91727159|NCT00098293|183349516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.4485|TWO_SIDED|95.0|0.64|1.22|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio \> 1 would favor maraviroc.||1.22|0.64|0.4485
91696332|NCT00529373|183286954|OTHER||Difference in Least Squares Means|1.08||||0.083|TWO_SIDED|95.0|-0.14|2.31|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.31|-0.14|0.083
91727160|NCT00098293|183349516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.2724|TWO_SIDED|95.0|0.61|1.15|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.15|0.61|0.2724
91727161|NCT00098293|183349517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.3943|TWO_SIDED|95.0|0.65|1.19|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.19|0.65|0.3943
91490540|NCT04645953|182853525|SUPERIORITY|||||||0.7919|||||||Mixed Models Analysis|||||||0.7919
91490541|NCT04613375|182853526|OTHER||Adjusted VE|16.91||||0.3685|TWO_SIDED|95.0|-24.43|44.52|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with respiratory syncytial virus (RSV) infection.|||44.52|-24.43|0.3685
91490542|NCT04613375|182853527|OTHER||Adjusted VE|49.27||||0.0817|TWO_SIDED|95.0|-8.9|76.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||76.37|-8.9|0.0817
91490543|NCT04613375|182853527|OTHER||Adjusted VE|4.72||||0.8367|TWO_SIDED|95.0|-50.96|39.87|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||39.87|-50.96|0.8367
91490544|NCT04613375|182853527|OTHER||Adjusted VE|12.02||||0.7469|TWO_SIDED|95.0|-91.53|59.59|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||59.59|-91.53|0.7469
91490545|NCT04613375|182853533|OTHER||Adjusted VE|25.96||||0.1827|TWO_SIDED|95.0|-15.21|52.42|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|||52.42|-15.21|0.1827
91490546|NCT04613375|182853534|OTHER||Adjusted VE|68.86||||0.028|TWO_SIDED|95.0|11.86|89.0|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||89|11.86|0.028
91490547|NCT04613375|182853534|OTHER||Adjusted VE|7.97||||0.738|TWO_SIDED|95.0|-49.73|43.43|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||43.43|-49.73|0.738
91727162|NCT00098293|183349517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.1289|TWO_SIDED|95.0|0.59|1.07|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.07|0.59|0.1289
91727163|NCT00098293|183349518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.1077||0.2741|TWO_SIDED|95.0|-0.094|0.329|||ANCOVA|||Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.329|-0.094|0.2741
91727164|NCT00098293|183349518|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1162||0.3899|TWO_SIDED|95.0|-0.128|0.328|||ANCOVA|||Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.328|-0.128|0.3899
91490548|NCT04613375|182853534|OTHER||Adjusted VE|30.06||||0.4327|TWO_SIDED|95.0|-70.86|71.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||71.37|-70.86|0.4327
91490549|NCT00434954|182853547|NON_INFERIORITY_OR_EQUIVALENCE|The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).|Mean Difference (Net)|0.14||||0.055|TWO_SIDED|95.0|-0.003|0.291||Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \< 0.4%.|Mixed effect model repeat measures(MMRM)|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.||0.291|-0.003|0.055
91490550|NCT00434954|182853548|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||Chi square test (Pearson)|||||||0.554
91528235|NCT01370005|182931725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-35.32|-25.08|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo.|||-25.08|-35.32|<0.0001
91727165|NCT00098293|183349519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.1002||0.2693|TWO_SIDED|95.0|-0.086|0.307|||ANCOVA|||Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.307|-0.086|0.2693
91727166|NCT00098293|183349519|SUPERIORITY_OR_OTHER||LS Mean Difference|0.089|STANDARD_ERROR_OF_MEAN|0.1121||0.427|TWO_SIDED|95.0|-0.131|0.309|||ANCOVA|||Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.309|-0.131|0.4270
91727167|NCT00098293|183349520|SUPERIORITY_OR_OTHER||LS Mean Difference|26.34|STANDARD_ERROR_OF_MEAN|9.827||0.0075|TWO_SIDED|95.0|7.04|45.63|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||45.63|7.04|0.0075
91727168|NCT00098293|183349520|SUPERIORITY_OR_OTHER||LS Mean Difference|35.44|STANDARD_ERROR_OF_MEAN|11.419||0.002|TWO_SIDED|95.0|13.02|57.86|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||57.86|13.02|0.0020
91490551|NCT00434954|182853549|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi square test (Pearson)|||||||0.159
91490552|NCT00434954|182853554|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Non overlapping 95% CI's: statistically significant difference p\<0.05.|Kaplan-Meier analysis|For each treatment group, the incidence of hypoglycemia at Week 26 and 95% CIs were derived from Kaplan-Meier analysis.||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).||||<0.05
91490553|NCT00434954|182853555|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at baseline \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
91727169|NCT00098293|183349521|SUPERIORITY_OR_OTHER||LS Mean Difference|166.29|STANDARD_ERROR_OF_MEAN|25.04|<|0.0001|TWO_SIDED|95.0|117.13|215.46|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||215.46|117.13|<0.0001
91727170|NCT00098293|183349521|SUPERIORITY_OR_OTHER||LS Mean Difference|172.22|STANDARD_ERROR_OF_MEAN|25.471|<|0.0001|TWO_SIDED|95.0|122.21|222.23|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||222.23|122.21|<0.0001
91727171|NCT00098293|183349522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.5874|TWO_SIDED|95.0|0.83|1.45|||Log Rank|||Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.45|0.83|0.5874
91727172|NCT00098293|183349522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4811|TWO_SIDED|95.0|0.86|1.4|||Log Rank|||Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.40|0.86|0.4811
91727173|NCT00098293|183349529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.2|||||ONE_SIDED|97.5|-10.2|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.2|
91727174|NCT00098293|183349529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-5.8|||||ONE_SIDED|97.5|-12.8|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-12.8|
91727175|NCT00098293|183349530|SUPERIORITY_OR_OTHER||Difference in Percentage|0.6|||||ONE_SIDED|97.5|-6.4|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-6.4|
91727176|NCT00098293|183349530|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||ONE_SIDED|97.5|-7.4|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.4|
91727177|NCT00098293|183349531|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||ONE_SIDED|97.5|-7.9|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.9|
91696333|NCT00529373|183286954|OTHER||Difference in Least Squares Means|1.05||||0.129|TWO_SIDED|95.0|-0.31|2.4|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.40|-0.31|0.129
91696334|NCT00529373|183286954|OTHER||Difference in Least Squares Means|1.21||||0.104|TWO_SIDED|95.0|-0.25|2.67|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.67|-0.25|0.104
91696335|NCT00529373|183286954|OTHER||Difference in Least Squares Means|1.55||||0.617|TWO_SIDED|95.0|-4.92|8.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.02|-4.92|0.617
91696336|NCT00529373|183286955|OTHER||Difference in Least Squares Means|-58.99|||<|0.001|TWO_SIDED|95.0|-64.68|-53.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-53.30|-64.68|<0.001
91696337|NCT00529373|183286955|OTHER||Difference in Least Squares Means|-60.01|||<|0.001|TWO_SIDED|95.0|-66.4|-53.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-53.61|-66.40|<0.001
91696338|NCT00529373|183286955|OTHER||Difference in Least Squares Means|-46.7|||<|0.001|TWO_SIDED|95.0|-53.23|-40.17|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-40.17|-53.23|<0.001
91696339|NCT00529373|183286955|OTHER||Difference in Least Squares Means|-44.67||||0.05|TWO_SIDED|95.0|-52.62|-36.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-36.72|-52.62|0.050
91696340|NCT00529373|183286955|OTHER||Difference in Least Squares Means|-18.73||||0.05|TWO_SIDED|95.0|-37.44|-0.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-0.01|-37.44|0.050
91696341|NCT00529373|183286956|OTHER||Difference in Least Squares Means|-51.7|||<|0.001|TWO_SIDED|95.0|-56.11|-47.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-47.28|-56.11|<0.001
91696342|NCT00529373|183286956|OTHER||Difference in Least Squares Means|-53.59|||<|0.001|TWO_SIDED|95.0|-58.39|-48.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-48.79|-58.39|<0.001
91696343|NCT00529373|183286956|OTHER||Difference in Least Squares Means|-56.68|||<|0.001|TWO_SIDED|95.0|-62.52|-50.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-50.84|-62.52|<0.001
91696344|NCT00529373|183286956|OTHER||Difference in Least Squares Means|-59.14|||<|0.001|TWO_SIDED|95.0|-66.04|-52.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-52.23|-66.04|<0.001
91696345|NCT00529373|183286956|OTHER||Difference in Least Squares Means|-44.54|||<|0.001|TWO_SIDED|95.0|-61.72|-27.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-27.36|-61.72|<0.001
91696346|NCT00529373|183286957|OTHER||Mean Difference (Final Values)|-14.13|||<|0.001|TWO_SIDED|95.0|-17.0|-11.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.27|-17.00|<0.001
91696347|NCT00529373|183286957|OTHER||Mean Difference (Final Values)|-12.01|||<|0.001|TWO_SIDED|95.0|-15.22|-8.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-8.79|-15.22|<0.001
91696348|NCT00529373|183286957|OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-13.45|-5.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-5.13|-13.45|<0.001
91696349|NCT00529373|183286957|OTHER||Mean Difference (Final Values)|-7.64|||<|0.001|TWO_SIDED|95.0|-11.87|-3.41|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-3.41|-11.87|<0.001
91696350|NCT00529373|183286957|OTHER||Mean Difference (Final Values)|-0.77||||0.896|TWO_SIDED|95.0|-12.34|10.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||10.79|-12.34|0.896
91696351|NCT00529373|183286958|OTHER||Mean Difference (Final Values)|-29.43|||<|0.001|TWO_SIDED|95.0|-33.47|-25.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-25.39|-33.47|<0.001
91696352|NCT00529373|183286958|OTHER||Mean Difference (Final Values)|-25.94|||<|0.001|TWO_SIDED|95.0|-30.54|-21.34|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-21.34|-30.54|<0.001
91696353|NCT00529373|183286958|OTHER||Mean Difference (Final Values)|-16.26|||<|0.001|TWO_SIDED|95.0|-21.41|-11.12|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.12|-21.41|<0.001
91696354|NCT00529373|183286958|OTHER||Mean Difference (Final Values)|-12.11|||<|0.001|TWO_SIDED|95.0|-18.03|-6.19|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-6.19|-18.03|<0.001
91696355|NCT00529373|183286958|OTHER||Mean Difference (Final Values)|-3.34||||0.61|TWO_SIDED|95.0|-16.12|9.45|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||9.45|-16.12|0.610
91696356|NCT00529373|183286959|OTHER||Hazard Ratio (HR)|1.12||||0.182|TWO_SIDED|95.0|0.95|1.34|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.34|0.95|0.182
91696357|NCT00529373|183286960|OTHER||Hazard Ratio (HR)|1.18||||0.235|TWO_SIDED|95.0|0.9|1.55|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.55|0.9|0.235
91696358|NCT00529373|183286961|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
91696359|NCT00529373|183286962|OTHER||Hazard Ratio (HR)|1.06||||0.857|TWO_SIDED|95.0|0.59|1.89|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.89|0.59|0.857
91696360|NCT00529373|183286963|OTHER||Hazard Ratio (HR)|1.1||||0.606|TWO_SIDED|95.0|0.76|1.59|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.59|0.76|0.606
91696361|NCT00529373|183286964|OTHER||Hazard Ratio (HR)|1.25||||0.074|TWO_SIDED|95.0|0.98|1.6|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.6|0.98|0.074
91696362|NCT00529373|183286965|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
91696363|NCT00529373|183286966|OTHER||Hazard Ratio (HR)|1.16||||0.277|TWO_SIDED|95.0|0.89|1.52|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.52|0.89|0.277
91696364|NCT00529373|183286967|OTHER||Hazard Ratio (HR)|0.82||||0.256|TWO_SIDED|95.0|0.58|1.15|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.15|0.58|0.256
91696365|NCT00529373|183286968|OTHER||Hazard Ratio (HR)|0.86||||0.794|TWO_SIDED|95.0|0.29|2.57|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.57|0.29|0.794
91727178|NCT00098293|183349531|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.9|||||ONE_SIDED|97.5|-11.5|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-11.5|
91727179|NCT03193307|183349547|OTHER||Geometric Mean (T1/R1) ratio (%)|153.2|||||TWO_SIDED|90.0|134.34|174.7|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =21.4."|||174.70|134.34|
91727180|NCT03193307|183349548|OTHER||Geometric Mean (T1/R1) ratio (%)|115.91|||||TWO_SIDED|90.0|104.559|128.502|||||"Analysis of variance (ANOVA) including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 16.7."|||128.502|104.559|
91727181|NCT03193307|183349549|OTHER||Geometric Mean (T2/R2) ratio (%)|104.82|||||TWO_SIDED|90.0|102.092|107.613|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =4.3."|||107.613|102.092|
91727182|NCT03193307|183349550|OTHER||Geometric Mean (T2/R2) ratio (%)|102.77|||||TWO_SIDED|90.0|100.66|104.92|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 3.3."|||104.92|100.66|
91727183|NCT03193307|183349551|OTHER||Geometric Mean (T2/R2) ratio (%)|114.12|||||TWO_SIDED|90.0|109.266|119.183|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\])=7.0."|||119.183|109.266|
91727184|NCT03193307|183349552|OTHER||Geometric Mean (T2/R2) ratio (%)|110.7|||||TWO_SIDED|90.0|105.8|115.83|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 7.3."|||115.83|105.80|
91490554|NCT00434954|182853556|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at Visit 1 \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
91528236|NCT01370005|182931726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.85|-1.13|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.13|-1.85|<0.0001
91727185|NCT03193307|183349553|OTHER||Geometric Mean (T1/R1) ratio (%)|154.15|||||TWO_SIDED|90.0|133.81|177.58|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 22.4."|||177.58|133.81|
91727186|NCT02186171|183349573|SUPERIORITY||LS Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|9.6|12.2||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||12.2|9.6|< 0.0001
91490555|NCT00002651|182853559|NON_INFERIORITY_OR_EQUIVALENCE|The overall type I error rate used is 0.05. The type II error rate is 0.10 (power = 0.9). The trial planned for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. A hazard ratio of 1.0 was used as the specific alternative in the trial size computations. Thus, rejection of the hypothesis will be evidence against the possibility that the intermittent CAD hazard ratio is larger than the continuous CAD hazard ratio by 20% or more.|Hazard Ratio (HR)|1.1||||0.15|TWO_SIDED|90.0|0.99|1.23|||Regression, Cox|||||1.23|0.99|0.15
91490556|NCT00002651|182853560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.09|TWO_SIDED|95.0|-0.31|3.97||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.97|-0.31|0.09
91490557|NCT00002651|182853561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.003|TWO_SIDED|95.0|1.0|4.76||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||4.76|1.00|0.003
91696366|NCT00529373|183286969|OTHER||Hazard Ratio (HR)|1.32||||0.034|TWO_SIDED|95.0|1.02|1.7|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.7|1.02|0.034
91696367|NCT00529373|183286970|OTHER||Hazard Ratio (HR)|1.91||||0.081|TWO_SIDED|95.0|0.93|3.97|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||3.97|0.93|0.081
91696368|NCT00529373|183286971|OTHER||Difference in Least Squares Means|1.47|||<|0.001|TWO_SIDED|95.0|0.92|2.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.01|0.92|<0.001
91727187|NCT02186171|183349574|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.3|3.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.7|2.3|< 0.0001
91727188|NCT02186171|183349575|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.5|3.3||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.3|1.5|< 0.0001
91490558|NCT00002651|182853562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|||<|0.001|TWO_SIDED|95.0|-14.0|-5.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||-5|-14|<0.001
91696369|NCT00529373|183286971|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
91696370|NCT00529373|183286971|OTHER||Difference in Least Squares Means|4.39|||<|0.001|TWO_SIDED|95.0|4.2|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.20|<0.001
91490559|NCT00002651|182853563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.04|TWO_SIDED|95.0|1.0|36.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||36|1|0.04
91490560|NCT00002651|182853564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.23|TWO_SIDED|95.0|-0.83|3.46||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.46|-0.83|0.23
91490561|NCT02096731|182853604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.92|1.37|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.37|0.92|
91490562|NCT02096731|182853605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.1|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.10|0.69|
91696371|NCT00529373|183286971|OTHER||Difference in Least Squares Means|6.5|||<|0.001|TWO_SIDED|95.0|6.28|6.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.72|6.28|<0.001
91696372|NCT00529373|183286971|OTHER||Difference in Least Squares Means|8.29|||<|0.001|TWO_SIDED|95.0|8.02|8.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.57|8.02|<0.001
91696373|NCT00529373|183286971|OTHER||Difference in Least Squares Means|10.05|||<|0.001|TWO_SIDED|95.0|9.72|10.38|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.38|9.72|<0.001
91696374|NCT00529373|183286972|OTHER||Difference in Least Squares Means|1.1|||<|0.001|TWO_SIDED|95.0|0.66|1.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.54|0.66|<0.001
91696375|NCT00529373|183286972|OTHER||Difference in Least Squares Means|1.36|||<|0.001|TWO_SIDED|95.0|0.87|1.85|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.85|0.87|<0.001
91490563|NCT02096731|182853606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.03|1.3|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.30|1.03|
91696376|NCT00529373|183286972|OTHER||Difference in Least Squares Means|1.96|||<|0.001|TWO_SIDED|95.0|1.42|2.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.50|1.42|<0.001
91696377|NCT00529373|183286972|OTHER||Difference in Least Squares Means|2.18|||<|0.001|TWO_SIDED|95.0|1.4|2.96|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.96|1.40|<0.001
91696378|NCT00529373|183286972|OTHER||Difference in Least Squares Means|2.33||||0.001|TWO_SIDED|95.0|1.54|3.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.11|1.54|0.001
91696379|NCT00529373|183286973|OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.45|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. the Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.45|0.24|<0.001
91696380|NCT00529373|183286974|OTHER||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.75|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.75|0.60|<0.001
91490564|NCT02096731|182853607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.36|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.36|0.81|
91696381|NCT00529373|183286975|OTHER||Difference in Least Squares Means|1.34|||<|0.001|TWO_SIDED|95.0|0.94|1.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.74|0.94|<0.001
91696382|NCT00529373|183286975|OTHER||Difference in Least Squares Means|2.5|||<|0.001|TWO_SIDED|95.0|2.38|2.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.62|2.38|<0.001
91696383|NCT00529373|183286975|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
91696384|NCT00529373|183286975|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.26|6.65|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.65|6.26|<0.001
91696385|NCT00529373|183286975|OTHER||Difference in Least Squares Means|8.48|||<|0.001|TWO_SIDED|95.0|8.24|8.73|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.73|8.24|<0.001
91696386|NCT00529373|183286975|OTHER||Difference in Least Squares Means|10.29|||<|0.001|TWO_SIDED|95.0|9.99|10.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.59|9.99|<0.001
91696387|NCT00529373|183286976|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.06|2.42|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.42|1.06|<0.001
91696388|NCT00529373|183286976|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
91696389|NCT00529373|183286976|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.16|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.16|<0.001
91696390|NCT00529373|183286976|OTHER||Difference in Least Squares Means|9.25|||<|0.001|TWO_SIDED|95.0|8.95|9.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.54|8.95|<0.001
91696391|NCT00529373|183286976|OTHER||Difference in Least Squares Means|12.14|||<|0.001|TWO_SIDED|95.0|11.76|12.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.51|11.76|<0.001
91490565|NCT02096731|182853608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|1.23|1.5|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.50|1.23|
91696392|NCT00529373|183286976|OTHER||Difference in Least Squares Means|14.56|||<|0.001|TWO_SIDED|95.0|14.11|15.01|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||15.01|14.11|<0.001
91696393|NCT00529373|183286977|OTHER||Difference in Least Squares Means|2.9|||<|0.001|TWO_SIDED|95.0|2.4|3.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.39|2.40|<0.001
91696394|NCT00529373|183286977|OTHER||Difference in Least Squares Means|4.01|||<|0.001|TWO_SIDED|95.0|3.87|4.15|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.15|3.87|<0.001
91696395|NCT00529373|183286977|OTHER||Difference in Least Squares Means|5.93|||<|0.001|TWO_SIDED|95.0|5.75|6.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.11|5.75|<0.001
91696396|NCT00529373|183286977|OTHER||Difference in Least Squares Means|7.7|||<|0.001|TWO_SIDED|95.0|7.48|7.91|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||7.91|7.48|<0.001
91727189|NCT02186171|183349576|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|7.6|9.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||9.7|7.6|< 0.0001
91696397|NCT00529373|183286977|OTHER||Difference in Least Squares Means|9.34|||<|0.001|TWO_SIDED|95.0|9.08|9.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.61|9.08|<0.001
91696398|NCT00529373|183286977|OTHER||Difference in Least Squares Means|10.87|||<|0.001|TWO_SIDED|95.0|10.55|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|10.55|<0.001
91696399|NCT00529373|183286986|OTHER||Difference in Least Squares Means|2.76|||<|0.001|TWO_SIDED|95.0|1.43|4.1|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.10|1.43|<0.001
91528237|NCT01370005|182931726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.33|-1.62|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.62|-2.33|<0.0001
91696400|NCT00529373|183286987|OTHER||Difference in Least Squares Means|5.55|||<|0.001|TWO_SIDED|95.0|4.06|7.05|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.05|4.06|<0.001
91696401|NCT00529373|183286988|OTHER||Difference in Least Squares Means|2.79||||0.005|TWO_SIDED|95.0|0.86|4.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.72|0.86|0.005
91696402|NCT00529373|183286989|OTHER||Difference in Least Squares Means|3.63|||<|0.001|TWO_SIDED|95.0|2.35|4.9|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.90|2.35|<0.001
91696403|NCT00529373|183286990|OTHER||Difference in Least Squares Means|5.65|||<|0.001|TWO_SIDED|95.0|3.79|7.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.50|3.79|<0.001
91696404|NCT00529373|183286991|OTHER||Difference in Least Squares Means|-62.25|||<|0.001|TWO_SIDED|95.0|-79.99|-44.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-44.50|-79.99|<0.001
91696405|NCT00529373|183286992|OTHER||Difference in Least Squares Means|-26.7||||0.001|TWO_SIDED|95.0|-42.56|-10.83|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-10.83|-42.56|0.001
91696406|NCT00529373|183286993|OTHER||Difference in Least Squares Means|1.67||||0.016|TWO_SIDED|95.0|0.32|3.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||3.01|0.32|0.016
91696407|NCT00529373|183286994|OTHER||Difference in Least Squares Means|-25.02|||<|0.001|TWO_SIDED|95.0|-35.92|-14.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-14.12|-35.92|<0.001
91696408|NCT00529373|183286995|OTHER||Difference in Least Squares Means|-64.43|||<|0.001|TWO_SIDED|95.0|-87.8|-41.07|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-41.07|-87.80|<0.001
91696409|NCT00529373|183286996|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|5.79|11.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||11.28|5.79|<0.001
91696410|NCT00529373|183286997|OTHER||Difference in Least Squares Means|11.08|||<|0.001|TWO_SIDED|95.0|8.41|13.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.74|8.41|<0.001
91696411|NCT00529373|183286998|OTHER||Difference in Least Squares Means|10.41|||<|0.001|TWO_SIDED|95.0|8.05|12.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||12.78|8.05|<0.001
91490566|NCT05673889|182853609|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.2|||||TWO_SIDED|90.0|166.56|221.79|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||221.79|166.56|
91696412|NCT00529373|183286999|OTHER||Difference in Least Squares Means|9.98|||<|0.001|TWO_SIDED|95.0|6.91|13.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.06|6.91|<0.001
91696413|NCT00529373|183287000|OTHER||Difference in Least Squares Means|14.94|||<|0.001|TWO_SIDED|95.0|11.29|18.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||18.59|11.29|<0.001
91696414|NCT00529373|183287001|OTHER||Hazard Ratio (HR)|0.79||||0.366|TWO_SIDED|95.0|0.47|1.33|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.33|0.47|0.366
91727190|NCT02186171|183349577|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|0.8|2.0||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.0|0.8|< 0.0001
91696415|NCT00529373|183287002|OTHER||Hazard Ratio (HR)|1.13||||0.246|TWO_SIDED|95.0|0.92|1.4|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.4|0.92|0.246
91727191|NCT02186171|183349578|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.4|=|0.0033|TWO_SIDED|95.0|0.4|2.1||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.1|0.4|= 0.0033
91490567|NCT05673889|182853610|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|197.81|||||TWO_SIDED|90.0|177.32|220.66|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||220.66|177.32|
91490568|NCT01776840|182853640|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.011|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||0.96|0.59|0.011
91696416|NCT00529373|183287003|OTHER||Hazard Ratio (HR)|0.8||||0.638|TWO_SIDED|95.0|0.32|2.03|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.03|0.32|0.638
91696417|NCT00529373|183287004|OTHER||Hazard Ratio (HR)|1.17||||0.029|TWO_SIDED|95.0|1.02|1.36|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.36|1.02|0.029
91696418|NCT00529373|183287005|OTHER||Hazard Ratio (HR)|1.05||||0.341|TWO_SIDED|95.0|0.95|1.17|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.17|0.95|0.341
91696419|NCT00529373|183287006|OTHER||Hazard Ratio (HR)|1.23||||0.198|TWO_SIDED|95.0|0.9|1.68|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.68|0.9|0.198
91696420|NCT00529373|183287007|OTHER||Hazard Ratio (HR)|0.94||||0.798|TWO_SIDED|95.0|0.7|1.26|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.26|0.7|0.798
91696421|NCT00529373|183287008|OTHER||Hazard Ratio (HR)|1.37||||0.005|TWO_SIDED|95.0|1.1|1.71|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.71|1.1|0.005
91696422|NCT00529373|183287009|OTHER||Hazard Ratio (HR)|1.22||||0.059|TWO_SIDED|95.0|0.99|1.5|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.5|0.99|0.059
91696423|NCT00529373|183287010|OTHER||Hazard Ratio (HR)|1.61||||0.114|TWO_SIDED|95.0|0.89|2.9|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.9|0.89|0.114
91696424|NCT00529373|183287011|OTHER||Hazard Ratio (HR)|1.14||||0.159|TWO_SIDED|95.0|0.99|1.31|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.31|0.99|0.159
91696425|NCT00529373|183287012|OTHER||Hazard Ratio (HR)|1.17||||0.178|TWO_SIDED|95.0|0.93|1.46|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.46|0.93|0.178
91696426|NCT00529373|183287013|OTHER|Miettinen \& Nurminen|Difference in rates|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
91696427|NCT00529373|183287014|OTHER|Miettinen \& Nurminen|Difference in rates|0.02|||||TWO_SIDED|95.0|0.01|0.05||||||||0.05|0.01|
91696428|NCT00529373|183287015|OTHER|Miettinen \& Nurminen|Difference in rates|0.06|||||TWO_SIDED|95.0|0.03|0.11||||||||0.11|0.03|
91696429|NCT00529373|183287016|OTHER|Miettinen \& Nurminen|Difference in rates|0.03|||||TWO_SIDED|95.0|0.02|0.06||||||||0.06|0.02|
91696430|NCT01385137|183287037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.58|TWO_SIDED|95.0|-0.79|0.44|||Regression, Linear|||||0.44|-0.79|0.58
91696431|NCT01385137|183287039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.42|TWO_SIDED|95.0|-7.3|3.04|||Regression, Linear|||||3.04|-7.30|0.42
91727192|NCT01245062|183349579|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.64||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Investigator-Assessed PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.64|0.31|<0.0001
91727193|NCT01245062|183349579|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Independent Review PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.60|0.29|<0.0001
91727194|NCT06025695|183349598|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in seroconversion rate|-3.73|||||TWO_SIDED|95.0|-6.93|-0.55|||||The asymptotic standardized 95% CI for the difference in seroconversion rate between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post-Dose 2.||-0.55|-6.93|
91727195|NCT06025695|183349599|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.|GMC Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||The comparison is done using the group GMC ratio (HRV PCV-free/HRV) (ANOVA model applied to the log10-transformed titers). The ANOVA model included the group as a fixed effect.|To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post-Dose 2.||0.84|0.60|
91727196|NCT06025695|183349600|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in percentage|-6.37|||||TWO_SIDED|95.0|-10.81|-1.92|||||The asymptotic standardized 95% CI for the difference in in the percentage between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations \>=90 U/mL 1 month post-Dose 2.||-1.92|-10.81|
91727197|NCT01452347|183349604|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|74.22|STANDARD_ERROR_OF_MEAN|1.05||||95.0|68.08|80.91|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||80.91|68.08|
91727198|NCT01452347|183349605|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|84.46|STANDARD_ERROR_OF_MEAN|1.11||||95.0|70.32|101.44|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||101.44|70.32|
91727199|NCT01452347|183349606|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|95.5|STANDARD_ERROR_OF_MEAN|1.05||||95.0|88.69|102.84|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||102.84|88.69|
91727200|NCT01452347|183349607|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|103.25|STANDARD_ERROR_OF_MEAN|1.11||||95.0|86.4|123.4|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||123.40|86.40|
91727201|NCT01452347|183349608|SUPERIORITY_OR_OTHER||||||<|0.001||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||<0.001
91727202|NCT01452347|183349609|SUPERIORITY_OR_OTHER|||||||0.05||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.05
91727203|NCT01452347|183349610|SUPERIORITY_OR_OTHER|||||||0.46||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.46
91727204|NCT01452347|183349611|SUPERIORITY_OR_OTHER|||||||0.65||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.65
91696432|NCT01385137|183287040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.77|TWO_SIDED|95.0|-4.17|5.6|||Regression, Linear|||||5.60|-4.17|0.77
91696433|NCT01385137|183287041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.21|TWO_SIDED|95.0|-1.16|5.44|||Regression, Linear|||||5.44|-1.16|0.21
91696434|NCT02347774|183287109|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.0736|STANDARD_ERROR_OF_MEAN|0.01989||0.0002|TWO_SIDED|95.0|0.0346|0.1127|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1127|0.0346|0.0002
91696435|NCT02347774|183287109|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.081|STANDARD_ERROR_OF_MEAN|0.02006||0.0001|TWO_SIDED|95.0|0.0416|0.1204|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1204|0.0416|0.0001
91696436|NCT02347774|183287110|SUPERIORITY||Least Mean Squared (SE)|0.082|STANDARD_ERROR_OF_MEAN|0.02055|<|0.0001|TWO_SIDED|95.0|0.0417|0.1224||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|I||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1224|0.0417|<0.0001
91727205|NCT05762744|183349612|OTHER|Unpaired two-tailed t-test to test null hypothesis||||||0.37||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: the order of FSIGTs (saline or exenatide-stimulated) does not affect the response during an FSIGT||||0.37
91727206|NCT05762744|183349613|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.66|||||||t-test, 2 sided|||Null hypothesis: The order of FSIGT (exenatide-stimulated or saline) does not affect the response to an FSIGT.||||0.66
91727207|NCT05762744|183349614|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.55|||||||t-test, 2 sided|||Null hypothesis: the order of testing (exenatide-stimulated or saline FSIGT) does not affect data obtained in the FSIGTs.||||0.55
91727208|NCT05762744|183349615|OTHER|Unpaired, two-tailed t-test to test the null hypothesis||||||0.45|||||||t-test, 2 sided|||The order of FSIGTs (exenatide-stimulated or saline) does not affect the response during an FSIGT||||0.45
91727209|NCT05762744|183349616|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.86||||||The t-test was conducted on the logarithms of the variable|t-test, 2 sided|||Null hypothesis: the order of FSIGT (exenatide or saline) does not affect the response during an FSIGT||||0.86
91727210|NCT05762744|183349617|OTHER|Two-tailed p-test for unpaired data||||||0.44||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: The order of FSIGTs (exenatide-stimulated or saline) does not affect the response to an FSIGT||||0.44
91727211|NCT05762744|183349618|OTHER|||||||0.41|||||||t-test, 2 sided|||"Null hypothesis: no differences between the two groups with respect to exenatide's effect on first-phase insulin secretion.~t-test conducted on logarithms of the values"||||0.41
91528238|NCT01370005|182931727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.37|-2.52|||ANCOVA|Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP|Difference calculated as empa 10mg minus placebo.|||-2.52|-5.37|<0.0001
91696437|NCT02347774|183287110|SUPERIORITY||Least Mean Squared (SE)|0.084|STANDARD_ERROR_OF_MEAN|0.02069||0.0001|TWO_SIDED|95.0|0.0433|0.1246||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1246|0.0433|0.0001
91727212|NCT05762744|183349618|OTHER|||||||0.38|||||||t-test, 2 sided|||Null hypothesis: no difference between two groups with respect to exenatide's effect on first phase insulin secretion||||0.38
91727213|NCT05762744|183349619|OTHER|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance||||0.80
91727214|NCT05762744|183349619|OTHER|||||||0.98|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance during an FSIGT||||0.98
91528239|NCT01370005|182931727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.78|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-6.2|-3.36|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP|Difference calculated as empa 25mg minus placebo.|||-3.36|-6.20|<0.0001
91727215|NCT01350973|183349620|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.876|TWO_SIDED|95.0|-4.2491|4.983||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||4.9830|-4.2491|0.8760
91727216|NCT01350973|183349620|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.35|||<|0.0001|TWO_SIDED|95.0|-15.9442|-6.7637||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||-6.7637|-15.9442|< 0.0001
91727217|NCT02507284|183349631|NON_INFERIORITY|Results for the secondary safety endpoint, adverse events (AEs) in study subjects, was performed using a test for non-inferiority with a threshold of 0.50. The null hypothesis is that the treatment minus placebo proportion difference is greater than (or equal to) the margin of 0.50 and the alternative hypothesis is that the difference is less than 0.50.|Risk Ratio (RR)|0.025||||0.5|ONE_SIDED|97.5|||||t-test, 1 sided|||||||0.50
91727218|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 18 to 34||0.01|0.01|
91727219|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 35 to 44||0.01|0.01|
91727220|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.03|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 45 to 54||0.04|0.03|
91727221|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.07|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 55 to 64||0.09|0.07|
91727222|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.11|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 65 to 74||0.14|0.11|
91727223|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.18|||||TWO_SIDED|95.0|0.15|0.21|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age ≥75||0.21|0.15|
91727224|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.09|||||TWO_SIDED|95.0|0.06|0.13|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 18 to 34||0.13|0.06|
91727225|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.11|||||TWO_SIDED|95.0|0.08|0.16|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 35 to 44||0.16|0.08|
91727226|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.3|0.45|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 45 to 54||0.45|0.30|
91727227|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.83|||||TWO_SIDED|95.0|2.68|5.47|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 65 to 74||5.47|2.68|
91727228|NCT01260324|183349632|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.73|||||TWO_SIDED|95.0|4.0|8.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age ≥75||8.22|4.00|
91727229|NCT01260324|183349633|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Female||0.05|0.04|
91727230|NCT01260324|183349633|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Male||0.06|0.05|
91727231|NCT01260324|183349633|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.5|2.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Male||2.22|1.50|
91727232|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2003||0.05|0.04|
91696438|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.51||0.6|TWO_SIDED|95.0|-0.73|1.25||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.25|-0.73|0.60
91727233|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2004||0.05|0.04|
91727234|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2005||0.05|0.04|
91727235|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2006||0.05|0.04|
91727236|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2007||0.05|0.04|
91490569|NCT05338216|182853656|SUPERIORITY||Mean Difference (Final Values)|19.63||||0.021||95.0|4.37|36.24||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Compliance would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||36.24|4.37|0.021
91490570|NCT05338216|182853657|SUPERIORITY||Mean Difference (Final Values)|17.34||||0.027||95.0|0.78|32.77||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Completion would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||32.77|0.78|0.027
91490571|NCT01350492|182853745|SUPERIORITY||Wilks' Lambda|0.939||||0.68|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.680
91727237|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2004||0.96|0.61|
91727238|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2005||0.91|0.58|
91727239|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2006||1.12|0.68|
91727240|NCT01260324|183349634|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.19|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2007||1.19|0.72|
91490572|NCT01350492|182853746|SUPERIORITY||Wilks' Lambda|0.96||||0.854|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mulitvariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.854
91696439|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.73||0.29|TWO_SIDED|95.0|-2.22|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.66|-2.22|0.29
91696440|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.72||0.73|TWO_SIDED|95.0|-1.67|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.16|-1.67|0.73
91727241|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Northeast||0.06|0.04|
91727242|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Midwest||0.05|0.04|
91727243|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate South||0.06|0.05|
91727244|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate West||0.05|0.04|
91705368|NCT01306214|183305230|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11||0.0005|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.13|-0.62|0.0005
91727245|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.31|0.56|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Northeast||0.56|0.31|
91727246|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.56|0.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Midwest||0.84|0.56|
91727247|NCT01260324|183349635|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.57|0.93|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio West||0.93|0.57|
91727248|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diabetes||0.10|0.08|
91528240|NCT01370005|182931728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.44||0.0004|TWO_SIDED|95.0|-2.42|-0.69|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 10mg minus placebo.|||-0.69|-2.42|0.0004
91727249|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.11|||||TWO_SIDED|95.0|0.08|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Smoking||0.14|0.08|
91727250|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.03|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Obesity||0.06|0.03|
91490573|NCT01350492|182853747|SUPERIORITY|||||||0.0002||||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.0002
91490574|NCT01350492|182853748|SUPERIORITY||Wilks' Lambda|0.857||||0.41|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.41
91696441|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.04||0.77|TWO_SIDED|95.0|-2.34|1.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.74|-2.34|0.77
91696442|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|1.1||0.51|TWO_SIDED|95.0|-1.43|2.88||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.88|-1.43|0.51
91696443|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.02||0.05|TWO_SIDED|95.0|0.02|4.01||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||4.01|0.02|0.05
91727251|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.06|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Nitrates||0.09|0.06|
91727252|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.15|||||TWO_SIDED|95.0|0.12|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Anti-platelet agents||0.18|0.12|
91727253|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diuretics||0.17|0.09|
91727254|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.01|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent PDE-5 inhibitors use||0.04|0.01|
91727255|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|1.47|2.25|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diabetes||2.25|1.47|
91727256|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.63|2.85|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Smoking||2.85|0.63|
91727257|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.23|0.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Obesity||0.81|0.23|
91727258|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.42|0.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Nitrates||0.94|0.42|
91727259|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.53|2.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Anti-platelet agents||2.94|1.53|
91528241|NCT01370005|182931728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.84|-1.12|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 25mg minus placebo.|||-1.12|-2.84|<0.0001
91696444|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|1.49||0.54|TWO_SIDED|95.0|-3.84|2.02||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.02|-3.84|0.54
91696445|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.61||0.21|TWO_SIDED|95.0|-1.13|5.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||5.17|-1.13|0.21
91696446|NCT04075682|183287127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|1.48||0.47|TWO_SIDED|95.0|-3.97|1.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.83|-3.97|0.47
91727260|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.46|3.43|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diuretics||3.43|1.46|
91727261|NCT01260324|183349636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57|||||TWO_SIDED|95.0|0.31|1.04|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Recent PDE-5 inhibitors use||1.04|0.31|
91727262|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other retinal disorders||0.39|0.28|
91727263|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.11|0.16|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Glaucoma||0.16|0.11|
91727264|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.2|||||TWO_SIDED|95.0|0.08|0.41|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Cataract||0.41|0.08|
91727265|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.99|||||TWO_SIDED|95.0|0.83|1.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Visual disturbances||1.17|0.83|
91727266|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|2.0|||||TWO_SIDED|95.0|1.6|2.46|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Blindness and low vision||2.46|1.60|
91727267|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.19|||||TWO_SIDED|95.0|0.16|0.23|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of eye||0.23|0.16|
91727268|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.22|||||TWO_SIDED|95.0|0.18|0.27|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Occlusion and stenosis of precerebral arteries||0.27|0.18|
91727269|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Acute sinusitis||0.08|0.05|
91727270|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other dermatoses||0.08|0.05|
91727271|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.06|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of bone and cartilage||0.10|0.06|
91727272|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.1|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Symptoms involving head and neck||0.14|0.10|
91727273|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.14|||||TWO_SIDED|95.0|0.1|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other ill defined and unknown causes of morbidity and mortality||0.18|0.10|
91490575|NCT01350492|182853749|SUPERIORITY||Wilks' Lambda|0.828||||0.16|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.16
91727274|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.65|||||TWO_SIDED|95.0|4.72|9.38|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other retinal disorders||9.38|4.72|
91727275|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.77|3.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Glaucoma||3.81|1.77|
91727276|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|1.02|1.68|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Cataract||1.68|1.02|
91727277|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|14.2|||||TWO_SIDED|95.0|10.4|19.3|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Visual disturbances||19.30|10.40|
91727278|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.1|||||TWO_SIDED|95.0|6.6|34.5|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Blindness and low vision||34.50|6.60|
91727279|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||||TWO_SIDED|95.0|1.44|2.82|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of eye||2.82|1.44|
91727280|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.64|2.31|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Occlusion and stenosis of precerebral arteries||2.31|0.64|
91727281|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.96|1.74|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Acute sinusitis||1.74|0.96|
91727282|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|1.02|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other dermatoses||1.77|1.02|
91727283|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of bone and cartilage||1.77|0.98|
91727284|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.02|1.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Symptoms involving head and neck||1.84|1.02|
91727285|NCT01260324|183349637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.08|2.49|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Ill defined and unknown causes of morbidity and mortality||2.49|1.08|
91727286|NCT01260324|183349638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.07|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent use||0.07|0.03|
91727287|NCT01260324|183349638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.04|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Any use (includes chronic and non-chronic use)||0.08|0.04|
91727288|NCT01260324|183349638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Chronic use||0.08|0.03|
91727289|NCT01260324|183349638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.03|0.11|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Non-chronic use||0.11|0.03|
91696447|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.49||0.57|TWO_SIDED|95.0|-0.68|1.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.24|-0.68|0.57
91696448|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.08|TWO_SIDED|95.0|-2.63|0.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.14|-2.63|0.08
91696449|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.39|TWO_SIDED|95.0|-1.97|0.77||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment, comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.77|-1.97|0.39
91727290|NCT01260324|183349638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Never use||0.10|0.08|
91727291|NCT01160744|183349646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.1318|TWO_SIDED|90.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.1318
91727292|NCT01160744|183349646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.5215|TWO_SIDED|90.0|0.64|1.22|||Log Rank|||||1.22|0.64|0.5215
91727293|NCT01160744|183349647|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||0.1797|TWO_SIDED|90.0|0.9|2.78|||Chi-squared|||||2.78|0.90|0.1797
91727294|NCT01160744|183349647|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.66||||0.007|TWO_SIDED|90.0|1.45|4.86|||Chi-squared|||||4.86|1.45|0.0070
91727295|NCT01160744|183349648|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.8916|TWO_SIDED|90.0|0.74|1.42|||Log Rank|||||1.42|0.74|0.8916
91727296|NCT01160744|183349648|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6847|TWO_SIDED|90.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6847
91727297|NCT01160744|183349651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0316|TWO_SIDED|90.0|1.22|5.02|||Chi-squared|||||5.02|1.22|0.0316
91727298|NCT01160744|183349651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.3962|TWO_SIDED|90.0|0.74|2.52|||Chi-squared|||||2.52|0.74|0.3962
91727299|NCT01160744|183349652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1571|TWO_SIDED||||||t-test, 2 sided|||||||0.1571
91727300|NCT01160744|183349652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1597|TWO_SIDED||||||t-test, 2 sided|||||||0.1597
91727301|NCT03156621|183349673|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-51.2|-19.9||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM||p-value vs Placebo|||-19.9|-51.2|<0.0001
91727302|NCT03156621|183349674|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-42.3|-17.3||p-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-17.3|-42.3|< 0.0001
91727303|NCT03156621|183349675|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|-47.6|-18.2||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-18.2|-47.6|< 0.0001
91727304|NCT03156621|183349676|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_DEVIATION|6.2|<|0.0001|TWO_SIDED|95.0|-38.9|-14.0||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||-14.0|-38.9|< 0.0001
91727305|NCT03156621|183349677|SUPERIORITY||Odds Ratio, log|12.2|||=|0.0004|TWO_SIDED|95.0|3.1|48.8|||Regression, Logistic|||||48.8|3.1|= 0.0004
91727306|NCT03156621|183349678|SUPERIORITY||Odds Ratio, log|36.5|||=|0.001|TWO_SIDED|95.0|4.3|308.9|||Regression, Logistic|||||308.9|4.3|= 0.0010
91727307|NCT03156621|183349679|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|95.0|-41.5|-15.2|||Regression model|||||-15.2|-41.5|< 0.0001
91727308|NCT03156621|183349680|SUPERIORITY||Odds Ratio (OR)|17.7|||=|0.0017|TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist||Exact Conditional Logistic Regression||||||3.3|= 0.0017
91727309|NCT03156621|183349681|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|=|0.3541|TWO_SIDED|95.0|-4.1|11.3||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||11.3|-4.1|= 0.3541
91727310|NCT03156621|183349682|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
91727311|NCT03156621|183349683|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_DEVIATION|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
91727312|NCT03156621|183349684|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-51.2|-19.9||||||||-19.9|-51.2|
91727313|NCT03156621|183349685|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-43.3|-17.3||||||||-17.3|-43.3|
91727314|NCT03156621|183349686|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|||TWO_SIDED|95.0|-47.6|-18.2||||||||-18.2|-47.6|
91727315|NCT03156621|183349687|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-28.9|-14.0||||||||-14.0|-28.9|
91727316|NCT03156621|183349688|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-41.5|-15.2||||||||-15.2|-41.5|
91727317|NCT03156621|183349689|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.1|11.3||||||||11.3|-4.1|
91727318|NCT03156621|183349690|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
91727319|NCT03156621|183349691|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
91727320|NCT03156621|183349692|SUPERIORITY||Odds Ratio (OR)|12.2|||||TWO_SIDED|95.0|3.1|48.8||||||≥15% reduction||48.8|3.1|
91727321|NCT03156621|183349692|SUPERIORITY|≥ 30% reduction|Odds Ratio (OR)|36.5|||||TWO_SIDED|95.0|4.3|308.9||||||||308.9|4.3|
91727322|NCT03156621|183349692|SUPERIORITY||Odds Ratio (OR)|17.7|||||TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist|||||≥ 50% reduction|||3.3|
91727323|NCT03156621|183349693|SUPERIORITY||Least squares (LS) mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.6|-0.1||||||||-0.1|-0.6|
91727324|NCT03016403|183349712|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0057|TWO_SIDED|95.0|0.52|2.98||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.98|0.52|0.0057
91727325|NCT03016403|183349713|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.0243|TWO_SIDED|95.0|0.19|2.73||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||2.73|0.19|0.0243
91727326|NCT03016403|183349714|SUPERIORITY||Mean Difference (Final Values)|-15.31||||0.0061|TWO_SIDED|95.0|-26.23|-4.39||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||-4.39|-26.23|0.0061
91760026|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.3|0.15||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.15|-0.30|
91760027|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.63|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.63|
91760028|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.64|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.64|
91490576|NCT01350492|182853750|SUPERIORITY||Wilks' Lambda|0.919||||0.66|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.66
91696450|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.0||0.61|TWO_SIDED|95.0|-1.45|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.47|-1.45|0.61
91696451|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.07||0.9|TWO_SIDED|95.0|-2.23|1.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.97|-2.23|0.90
91696452|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|0.98||0.04|TWO_SIDED|95.0|0.13|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.97|0.13|0.04
91696453|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|1.43||0.64|TWO_SIDED|95.0|-2.14|3.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.48|-2.14|0.64
91696454|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|1.56||0.92|TWO_SIDED|95.0|-2.91|3.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.20|-2.91|0.92
91758716|NCT00235716|183410639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.17||||0.03|TWO_SIDED|95.0|-3.71|-0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.63|-3.71|0.03
91758717|NCT00235716|183410640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.13||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for vitamin E group relative to the placebo group.|||1.13|0.67|0.31
91758718|NCT00235716|183410640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the memantine group relative to the placebo group.|||1.24|0.91|0.47
91758719|NCT00235716|183410640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.57|1.54||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the vitamin E + memantine group relative to the placebo group.|||1.54|0.57|0.80
91490577|NCT03800173|182853769|OTHER||Slope|0.982|||||TWO_SIDED|90.0|0.868|1.096||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.096|0.868|
91696455|NCT04075682|183287128|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.25|STANDARD_ERROR_OF_MEAN|1.41||0.11|TWO_SIDED|95.0|-5.02|0.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||0.52|-5.02|0.11
91696456|NCT04075682|183287129|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.59||0.57|TWO_SIDED|95.0|-1.48|0.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.82|-1.48|0.57
91696457|NCT04075682|183287129|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.14||0.39|TWO_SIDED|95.0|-3.22|1.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial warnings (averaged over insert) vs no pictorial warnings (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.27|-3.22|0.39
91696458|NCT04075682|183287129|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|1.63||0.92|TWO_SIDED|95.0|-3.35|3.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.04|-3.35|0.92
91696459|NCT04075682|183287130|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4|TWO_SIDED|95.0|-1.33|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.53|-1.33|0.40
91727327|NCT03016403|183349715|SUPERIORITY||Mean Difference (Final Values)|-7.73||||0.21|TWO_SIDED|95.0|-19.73|4.27||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.27|-19.73|0.21
91490578|NCT03800173|182853770|OTHER||Slope|1.0|||||TWO_SIDED|90.0|0.872|1.128||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1||1.128|0.872|
91490579|NCT03800173|182853770|OTHER||Slope|1.086|||||TWO_SIDED|90.0|0.952|1.219||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.219|0.952|
91727328|NCT03016403|183349716|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.052|TWO_SIDED|95.0|-0.01|3.05||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.05|-0.01|0.052
91727329|NCT03016403|183349717|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.214|TWO_SIDED|95.0|-0.52|2.36||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.36|-0.52|0.214
91490580|NCT02149719|182853772|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91490581|NCT01235689|182853815|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by Screening smoking status (yes or no) and weight (\< 70 kg or ≥ 70 kg).||||||0.010
91490582|NCT01235689|182853816|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.014
91727330|NCT03016403|183349718|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.0134|TWO_SIDED|95.0|-7.45|-0.87||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||-0.87|-7.45|0.0134
91727331|NCT03016403|183349719|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.42|TWO_SIDED|95.0|-0.9|2.12||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.12|-0.9|0.42
91758720|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|105.2|||||TWO_SIDED|90.0|90.61|122.13||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||122.13|90.61|
91490583|NCT01235689|182853817|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.006
91490584|NCT01235689|182853818|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.010
91490585|NCT01235689|182853819|SUPERIORITY|||||||0.299|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.299
91490586|NCT01235689|182853820|SUPERIORITY|||||||0.728|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.728
91490587|NCT01235689|182853821|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.067
91490588|NCT01235689|182853822|SUPERIORITY||LS Mean Difference|-1.4||||0.116|TWO_SIDED|95.0|-3.2|0.4|||ANCOVA|Model included factors for treatment group, screening smoking status (yes or no), and weight (\< 70 kg, ≥ 70 kg), and Baseline values as covariate.||||0.4|-3.2|0.116
91490589|NCT01235689|182853824|SUPERIORITY||Cox Proportional Hazard|0.442||||0.012|TWO_SIDED|95.0|0.2|0.8|||Regression, Cox|||||0.8|0.2|0.012
91490590|NCT01235689|182853825|SUPERIORITY||Cox Proportional Hazard|1.45||||0.008|TWO_SIDED|95.0|1.1|1.9|||Regression, Cox|||||1.9|1.1|0.008
91490591|NCT01235689|182853826|SUPERIORITY||Cox Proportional Hazard|1.337||||0.052|TWO_SIDED|95.0|1.0|1.8|||Regression, Cox|||||1.8|1.0|0.052
91490592|NCT01235689|182853829|SUPERIORITY||Cox Proportional Hazard|0.823||||0.501|TWO_SIDED|95.0|0.5|1.5|||Regression, Cox|||||1.5|0.5|0.501
91490593|NCT01235689|182853830|SUPERIORITY||Cox Proportional Hazard|0.785||||0.459|TWO_SIDED|95.0|0.4|1.5|||Regression, Cox|||||1.5|0.4|0.459
91490594|NCT01235689|182853837|SUPERIORITY||Cox Proportional Hazard|0.423||||0.212|TWO_SIDED|95.0|0.1|1.6|||Regression, Cox|||||1.6|0.1|0.212
91528242|NCT01370005|182931729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0021|TWO_SIDED|95.0|-4.09|-0.91|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 10mg minus placebo.|||-0.91|-4.09|0.0021
91528243|NCT01370005|182931729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0003|TWO_SIDED|95.0|-4.48|-1.32|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 25mg minus placebo.|||-1.32|-4.48|0.0003
91696460|NCT04075682|183287130|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.94||0.99|TWO_SIDED|95.0|-1.83|1.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial health warning labels (HWLs) (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.86|-1.83|0.99
91490595|NCT00806351|182853848|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
91490596|NCT00806351|182853849|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
91490597|NCT00806351|182853850|SUPERIORITY_OR_OTHER||Risk Difference|-40.0|||||TWO_SIDED|95.0|-97.5|63.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||63.9|-97.5|
91490598|NCT00806351|182853851|SUPERIORITY_OR_OTHER||Risk Difference|-50.0|||||TWO_SIDED|95.0|-97.5|55.0||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.0|-97.5|
91696461|NCT04075682|183287130|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|1.34||0.17|TWO_SIDED|95.0|-0.78|4.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.48|-0.78|0.17
91696462|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.58||0.45|TWO_SIDED|95.0|-0.69|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.57|-0.69|0.45
91696463|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.58||0.41|TWO_SIDED|95.0|-1.61|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-1.61|0.41
91696464|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.44|STANDARD_ERROR_OF_MEAN|0.84||0.08|TWO_SIDED|95.0|-3.08|0.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.20|-3.08|0.08
91727332|NCT03016403|183349720|SUPERIORITY||Mean Difference (Final Values)|1.77||||0.0269|TWO_SIDED|95.0|0.2|3.34||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.34|0.2|0.0269
91490599|NCT00806351|182853856|SUPERIORITY_OR_OTHER||Risk Difference|-36.4|||||TWO_SIDED|95.0|-90.6|31.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||31.9|-90.6|
91758721|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|65.76|||||TWO_SIDED|90.0|56.62|76.37||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||76.37|56.62|
91696465|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.82||0.52|TWO_SIDED|95.0|-2.14|1.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.09|-2.14|0.52
91696466|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|1.11||0.75|TWO_SIDED|95.0|-1.82|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.51|-1.82|0.75
91727333|NCT03016403|183349721|SUPERIORITY||Mean Difference (Final Values)|2.56||||0.0044|TWO_SIDED|95.0|0.8|4.32||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.32|0.8|0.0044
91727334|NCT04641975|183349746|SUPERIORITY||LS Mean difference|2.22|STANDARD_ERROR_OF_MEAN|1.34||0.121|TWO_SIDED|90.0|-0.15|4.59|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with change from baseline at week 12 Last Observation Carried Forward (LOCF) as response, treatment group, sex and geographical region as fixed effects and the mean number of micturitions per 24 hours at baseline as covariate.||4.59|-0.15|0.121
91727335|NCT04641975|183349747|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
91727336|NCT04641975|183349747|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
91727337|NCT04641975|183349748|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
91727338|NCT04641975|183349748|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
91727339|NCT04641975|183349749|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.53||0.073|TWO_SIDED|90.0|-1.99|-0.1|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.10|-1.99|0.073
91528244|NCT01370005|182931730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.0566|TWO_SIDED|95.0|-1.93|0.03|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 10mg minus placebo.|||0.03|-1.93|0.0566
91696467|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.57||0.64|TWO_SIDED|95.0|-3.82|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.33|-3.82|0.64
91696468|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.18||0.91|TWO_SIDED|95.0|-2.17|2.45||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.45|-2.17|0.91
91696469|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|1.25||0.5|TWO_SIDED|95.0|-3.29|1.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.60|-3.29|0.50
91696470|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.16||0.007|TWO_SIDED|95.0|0.86|5.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.41|0.86|0.007
91696471|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|1.69||0.52|TWO_SIDED|95.0|-2.22|4.4||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.40|-2.22|0.52
91696472|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.82||0.86|TWO_SIDED|95.0|-3.89|3.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.23|-3.89|0.86
91727340|NCT04641975|183349749|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.45||0.044|TWO_SIDED|90.0|-1.8|-0.2|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.20|-1.80|0.044
91490600|NCT00289783|182853877|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by Enzyme Linked Immunosorbent Assay (ELISA) the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
91727341|NCT04641975|183349750|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
91727342|NCT04641975|183349750|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
91727343|NCT04641975|183349751|SUPERIORITY||Mean Difference (Final Values)|2.48|STANDARD_ERROR_OF_MEAN|0.85||0.012|TWO_SIDED|90.0|0.97|3.99|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.99|0.97|0.012
91727344|NCT04641975|183349751|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|0.77||0.007|TWO_SIDED|90.0|1.1|3.82|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.82|1.10|0.007
91490601|NCT00289783|182853877|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
91490602|NCT00289783|182853877|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.26||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.26|0.8|
91727345|NCT04641975|183349752|SUPERIORITY||Rate ratio|0.2||||0.105|TWO_SIDED|90.0|0.04|1.02|||Binomial regression|||Without LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.02|0.04|0.105
91727346|NCT04641975|183349752|SUPERIORITY||Rate ratio|0.22||||0.111|TWO_SIDED|90.0|0.05|1.05|||Binomial regression|||With LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.05|0.05|0.111
91528245|NCT01370005|182931730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0208|TWO_SIDED|95.0|-2.12|-0.18|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 25mg minus placebo.|||-0.18|-2.12|0.0208
91727347|NCT01657500|183349771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|See above|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Main outcome measure was endothelial cell loss at 6 months after EK. Sample size and statistical power calculations for testing equivalence of means within 10% range were performed at 80% power/0.025 level of significance. 20% variability was assumed. 6-month endothelial cell loss) should not differ significantly for surgeon-prepared versus eye bank-prepared tissue. Assuming pairs of corneas matched by pt. diagnosis and other characteristics, the required sample size was 34 donor pairs.||||< 0.05
91727348|NCT03892915|183349788|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93||||||||1.93|0.73|
91727349|NCT03892915|183349789|SUPERIORITY||beta coefficient|5.33|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|||||||||||||
91727350|NCT03892915|183349791|SUPERIORITY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.53|6.5||||||||6.50|0.53|
91727351|NCT03892915|183349792|SUPERIORITY||Odds Ratio (OR)|2.73|||||TWO_SIDED|95.0|0.45|16.64||||||||16.64|0.45|
91727352|NCT03892915|183349793|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.05|0.83||||||||0.83|0.05|
91727353|NCT00449007|183349808|SUPERIORITY||Mean Difference (Final Values)|4.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Difference between 6 months and baseline for Bupropion treated group.~Due to the low number of participants, the results are unreliable."||||1.0
91727354|NCT03566550|183349811|OTHER|||||||0.04|||||||Log Rank|||||||0.04
91696473|NCT04075682|183287131|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.68||0.61|TWO_SIDED|95.0|-4.15|2.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.43|-4.15|0.61
91696474|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.28||0.29|TWO_SIDED|95.0|0.82|1.96||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.96|0.82|0.29
91696475|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.27||0.43|TWO_SIDED|95.0|0.77|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.85|0.77|0.43
91727355|NCT03566550|183349812|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91727356|NCT03566550|183349813|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91727357|NCT03566550|183349814|OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91727358|NCT03566550|183349815|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91727359|NCT00986583|183349819|SUPERIORITY_OR_OTHER||Ratio of medians|1.34||||0.018|TWO_SIDED|95.0|1.05|1.72||This is for the primary comparison at 20 minute|ANCOVA||Ratio of medians of myoglobin measured at 20 minute for statin users vs. non-statin users|||1.72|1.05|0.018
91727360|NCT03518203|183349825|EQUIVALENCE|A binomial test was used to test 6 month survival in study cohort against an 18% historical rate.|Proportion|0.714|||<|0.0001|TWO_SIDED|||||The a priori threshold was 0.05.|binomial test|||||||<0.0001
91727361|NCT00345592|183349847|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987|||||TWO_SIDED|95.0|0.684|1.503||||||||1.503|0.684|
91727362|NCT00137280|183349848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.47|3.58|||Regression, Logistic||Comparison group is the control (denominator)|||3.58|1.47|<0.01
91727363|NCT00137280|183349849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.02|STANDARD_ERROR_OF_MEAN|5.93||0.03|||||||ANCOVA|||||||.03
91727364|NCT00137280|183349850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.22|4.34|||Regression, Logistic||Comparison group is the control (denominator)|||4.34|1.22|<0.01
91727365|NCT00137280|183349851|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||||||.11
91727366|NCT05001165|183349852|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.1|0.7|||Regression, Linear|||||0.7|-0.1|
91727367|NCT05001165|183349853|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.84|2.14|||Regression, Logistic|||||2.14|0.84|
91727368|NCT05001165|183349854|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED|95.0|0.64|1.76|||Regression, Logistic|||||1.76|0.64|<0.05
91727369|NCT05001165|183349855|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93|||Regression, Logistic|||||1.93|0.73|
91727370|NCT05001165|183349856|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.68|2.05|||Regression, Logistic|||||2.05|0.68|
91727371|NCT05001165|183349857|SUPERIORITY||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.88|2.51|||Regression, Logistic|||||2.51|0.88|
91727372|NCT05001165|183349858|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|0.99|3.64|||Regression, Logistic|||||3.64|0.99|
91727373|NCT05001165|183349859|SUPERIORITY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.34|1.33|||Regression, Logistic|||||1.33|0.34|
91727374|NCT03467945|183349864|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.4421|||||TWO_SIDED|90.0|75.2805|88.1079||||||||88.1079|75.2805|
91727375|NCT03467945|183349864|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
91727376|NCT03467945|183349864|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
91727377|NCT03467945|183349865|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
91727378|NCT03467945|183349865|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.7255|||||TWO_SIDED|90.0|101.1665|110.49||||||||110.4900|101.1665|
91727379|NCT03467945|183349865|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.7533|||||TWO_SIDED|90.0|92.5812|101.1135||||||||101.1135|92.5812|
91727380|NCT03467945|183349866|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|77.6923|||||TWO_SIDED|90.0|70.383|85.7606||||||||85.7606|70.3830|
91727381|NCT03467945|183349866|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
91528246|NCT01370005|182931731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-5.86|-1.98|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 10mg minus placebo.|||-1.98|-5.86|<0.0001
91528247|NCT01370005|182931731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.73|-2.87|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 25mg minus placebo.|||-2.87|-6.73|<0.0001
91696476|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.37||0.6|TWO_SIDED|95.0|0.63|2.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.20|0.63|0.60
91727382|NCT03467945|183349866|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|79.4367|||||TWO_SIDED|90.0|71.9633|87.6861||||||||87.6861|71.9633|
91727383|NCT03467945|183349867|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
91727384|NCT03467945|183349867|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|93.6828|||||TWO_SIDED|90.0|88.6166|99.0386||||||||99.0386|88.6166|
91727385|NCT03467945|183349867|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|115.37|||||TWO_SIDED|90.0|109.131|121.9658||||||||121.9658|109.1310|
91727386|NCT03467945|183349868|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|82.6022|||||TWO_SIDED|90.0|76.5513|89.1314||||||||89.1314|76.5513|
91727387|NCT03467945|183349868|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
91727388|NCT03467945|183349868|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
91528248|NCT01370005|182931732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.55||0.0005|TWO_SIDED|95.0|-3.01|-0.84|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 10mg minus placebo.|||-0.84|-3.01|0.0005
91727389|NCT03467945|183349869|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.5947|106.2906||||||||106.2906|97.5947|
91727390|NCT03467945|183349869|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.915|||||TWO_SIDED|90.0|101.49|110.533||||||||110.5330|101.4900|
91727391|NCT03467945|183349869|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.1619|||||TWO_SIDED|90.0|92.1443|100.3546||||||||100.3546|92.1443|
91696477|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.25|STANDARD_ERROR_OF_MEAN|0.4||0.48|TWO_SIDED|95.0|0.67|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.33|0.67|0.48
91727392|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727393|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727394|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727395|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91696478|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.36||0.62|TWO_SIDED|95.0|0.34|1.91||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.91|0.34|0.62
91696479|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.04|STANDARD_ERROR_OF_MEAN|1.93||0.079|TWO_SIDED|95.0|0.88|10.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||10.52|0.88|0.079
91696480|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.95||0.1|TWO_SIDED|95.0|0.87|5.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||5.12|0.87|0.10
91696481|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.68||0.52|TWO_SIDED|95.0|0.52|3.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.61|0.52|0.52
91696482|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.54|TWO_SIDED|95.0|0.55|3.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.17|0.55|0.54
91758722|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|94.08|||||TWO_SIDED|90.0|82.51|107.27||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||107.27|82.51|
91758723|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|127.18|||||TWO_SIDED|90.0|94.89|170.45||||||AUCtau of LDV for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||170.45|94.89|
91758724|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|82.25|||||TWO_SIDED|90.0|61.34|110.3||||||AUCtau of LDV for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||110.30|61.34|
91758725|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|120.46|||||TWO_SIDED|90.0|93.18|155.73||||||AUCtau of LDV for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||155.73|93.18|
91490603|NCT00289783|182853878|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.23|||||TWO_SIDED|95.0|0.93|1.62||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.62|0.93|
91528249|NCT01370005|182931732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.55||0.0006|TWO_SIDED|95.0|-2.97|-0.82|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 25mg minus placebo.|||-0.82|-2.97|0.0006
91696483|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.21||0.33|TWO_SIDED|95.0|0.53|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.61|0.53|0.33
91727396|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727397|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727398|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727399|NCT03336866|183349907|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727400|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91758726|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|159.88|||||TWO_SIDED|90.0|137.89|185.37||||||AUCtau of SOF for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||185.37|137.89|
91490604|NCT00289783|182853878|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.74|1.29||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.29|0.74|
91696484|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.53|STANDARD_ERROR_OF_MEAN|1.08||0.55|TWO_SIDED|95.0|0.38|6.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.11|0.38|0.55
91696485|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.39||0.44|TWO_SIDED|95.0|0.18|2.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.14|0.18|0.44
91696486|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.28||0.251|TWO_SIDED|95.0|0.84|1.98||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation models for pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.98|0.84|0.2510
91696487|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.28||0.2822|TWO_SIDED|95.0|0.82|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.95|0.82|0.2822
91696488|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.34|STANDARD_ERROR_OF_MEAN|0.42||0.3558|TWO_SIDED|95.0|0.72|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for multiple imputation models for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.47|0.72|0.3558
91696489|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.36|STANDARD_ERROR_OF_MEAN|0.43||0.3291|TWO_SIDED|95.0|0.73|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.51|0.73|0.3291
91758727|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|110.79|151.32||||||AUCtau of SOF for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||151.32|110.79|
91758728|NCT02249182|183410648|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|187.76|||||TWO_SIDED|90.0|143.41|245.82||||||AUCtau of SOF for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||245.82|143.41|
91528250|NCT01370005|182931733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0021|TWO_SIDED|95.0|1.39|4.45|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||4.45|1.39|0.0021
91490605|NCT00289783|182853878|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.79|||||TWO_SIDED|95.0|0.6|1.04||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.04|0.6|
91490606|NCT00289783|182853879|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.61|||||TWO_SIDED|95.0|1.14|2.27||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||2.27|1.14|
91490607|NCT00289783|182853879|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.4|||||TWO_SIDED|95.0|0.99|1.97||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.97|0.99|
91490608|NCT00289783|182853879|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.62|1.21||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.21|0.62|
91490609|NCT00289783|182853880|NON_INFERIORITY|Criteria for immunogenicity of MenC (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|12.0|||||TWO_SIDED|95.0|10.4|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||13.8|10.4|
91490610|NCT00289783|182853880|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values)|GMT ratio|1.4|||||TWO_SIDED|95.0|1.4|1.4||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||1.4|1.4|
91758729|NCT00360568|183410708|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91490611|NCT00289783|182853881|NON_INFERIORITY|Criteria for immunogenicity of MenY (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|11.8|||||TWO_SIDED|95.0|10.2|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||13.8|10.2|
91490612|NCT00289783|182853881|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).|GMT ratio|21.1|||||TWO_SIDED|95.0|21.1|21.1||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||21.1|21.1|
91490613|NCT00289783|182853885|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 150 mIU/mL, in initially seronegative subjects (\<150 mIU/mL), for anti-measles antibody is ≥-5% (clinical limit for non-inferiority).|Difference in percentage|-0.15|||||TWO_SIDED|95.0|-2.56|3.06||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||3.06|-2.56|
91758730|NCT00360568|183410709|SUPERIORITY_OR_OTHER|||||||0.394|||||||t-test, 2 sided|||||||0.394
91490614|NCT00289783|182853886|NON_INFERIORITY|Criteria for non-inferiority (42 days after the fourth dose): Lower limit of the two-sided standardized asymptotic 95% CI on the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with anti-PRP concentration ≥ 1.0 µg/mL is ≥ -10% (clinical limit for non-inferiority)|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.78|3.57||||||To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.||3.57|-1.78|
91758731|NCT00360568|183410710|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91758732|NCT00360568|183410711|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91758733|NCT00360568|183410712|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||||||0.055
91758734|NCT00360568|183410713|SUPERIORITY_OR_OTHER|||||||0.766|||||||t-test, 2 sided|||||||0.766
91758735|NCT00360568|183410714|SUPERIORITY_OR_OTHER|||||||0.571|||||||t-test, 2 sided|||||||0.571
91758736|NCT00360568|183410715|SUPERIORITY_OR_OTHER|||||||0.583|||||||t-test, 2 sided|||||||0.583
91696490|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.39||0.7818|TWO_SIDED|95.0|0.38|2.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.09|0.38|0.7818
91696491|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.87|STANDARD_ERROR_OF_MEAN|1.79||0.0912|TWO_SIDED|95.0|0.84|9.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||9.73|0.84|0.0912
91696492|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.94|STANDARD_ERROR_OF_MEAN|0.87||0.1361|TWO_SIDED|95.0|0.81|4.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||4.66|0.81|0.1361
91696493|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.58||0.72|TWO_SIDED|95.0|0.46|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.07|0.46|0.7200
91696494|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.48|STANDARD_ERROR_OF_MEAN|0.66||0.3737|TWO_SIDED|95.0|0.62|3.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.53|0.62|0.3737
91528251|NCT01370005|182931733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0088|TWO_SIDED|95.0|1.22|3.96|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||3.96|1.22|0.0088
91727401|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727402|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91758737|NCT00360568|183410716|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91696495|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|1.63||0.1345|TWO_SIDED|95.0|0.75|8.9||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||8.90|0.75|0.1345
91696496|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.96|STANDARD_ERROR_OF_MEAN|1.36||0.3318|TWO_SIDED|95.0|0.5|7.67||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||7.67|0.50|0.3318
91727403|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727404|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727405|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727406|NCT03336866|183349908|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
91727407|NCT00032487|183349919|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.|Cox Proportional Hazard|0.79|||<|0.05|TWO_SIDED|95.0|0.79|0.99|||Log Rank|||It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.||.99|.79|<0.05
91727408|NCT01125748|183349938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||||TWO_SIDED|95.0|5.0|33.6||||||||33.6|5.0|
91758738|NCT00360568|183410717|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
91758739|NCT00360568|183410718|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||||||0.341
91513235|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.52||||||95.0|1.39|1.67||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.67|1.39|
91528252|NCT03691948|182931741|SUPERIORITY|||||||0.531|||||||ANOVA|||||||.531
91696497|NCT04075682|183287132|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.49||0.7017|TWO_SIDED|95.0|0.23|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.70|0.23|0.7017
91696498|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.47|STANDARD_ERROR_OF_MEAN|0.7||0.001|TWO_SIDED|95.0|1.42|4.31||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.31|1.42|0.001
91696499|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.54||0.025|TWO_SIDED|95.0|1.09|3.3||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.30|1.09|0.025
91727409|NCT01028391|183349940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-0.76|-0.26|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) HbA1c.|||-0.26|-0.76|
91727410|NCT01028391|183349941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-16.3|-0.7|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) FPG.|||-0.7|-16.3|
91727411|NCT01107457|183349942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||Fisher Exact|||||||0.079
91727412|NCT01107457|183349942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91727413|NCT01107457|183349942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91727414|NCT01107457|183349942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91727415|NCT01107457|183349943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91727416|NCT01107457|183349943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91727417|NCT01107457|183349943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91727418|NCT01107457|183349943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91727419|NCT01227395|183350022|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.696
91528253|NCT03691948|182931742|SUPERIORITY|||||||0.076|||||||ANOVA|||||||0.076
91727420|NCT01227395|183350023|SUPERIORITY_OR_OTHER||||||=|0.334|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.334
91727421|NCT01227395|183350024|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
91727422|NCT01227395|183350025|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
91727423|NCT01227395|183350026|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.015
91727424|NCT01227395|183350027|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
91727425|NCT01227395|183350028|SUPERIORITY_OR_OTHER||||||=|0.29|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.290
91727426|NCT01227395|183350029|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.003
91727427|NCT01227395|183350030|SUPERIORITY_OR_OTHER||||||=|0.707|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.707
91758740|NCT00360568|183410719|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.220
91696500|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.37|STANDARD_ERROR_OF_MEAN|0.56||0.44|TWO_SIDED|95.0|0.62|3.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.06|0.62|0.44
91696501|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.73||0.15|TWO_SIDED|95.0|0.81|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||3.97|0.81|0.15
91490615|NCT00289783|182853887|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with a seroconversion ≥28 ED50, in subjects with initial anti-mumps antibody \< 28 ED50, for anti-mumps antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-2.16|0.98||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||0.98|-2.16|
91696502|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.67||0.76|TWO_SIDED|95.0|0.39|3.58||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.58|0.39|0.76
91696503|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.63||0.77|TWO_SIDED|95.0|0.16|3.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.80|0.16|0.77
91696504|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.18|STANDARD_ERROR_OF_MEAN|1.23||0.17|TWO_SIDED|95.0|0.72|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.61|0.72|0.17
91705369|NCT01306214|183305230|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|H013: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo \>0.3 Ha13: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo ≤0.3||-0.22|-0.70|<0.0001
91727428|NCT00809146|183350059|NON_INFERIORITY_OR_EQUIVALENCE|Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|0.04|0.16|||one-sided z statistic|||The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.||0.16|0.04|<0.001
91727429|NCT00809146|183350060|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.7|1.34||||||||1.34|0.70|
91727430|NCT00809146|183350061|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
91490616|NCT00289783|182853888|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroresponse ≥10 IU/ml, in initially seronegative subjects (\< 4 IU/ml), for anti-rubella antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|0.12|||||TWO_SIDED|95.0|-0.57|1.73||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||1.73|-0.57|
91513236|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6||||||95.0|0.54|0.67||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.67|0.54|
91696505|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.46|STANDARD_ERROR_OF_MEAN|0.29||0.22|TWO_SIDED|95.0|0.14|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.57|0.14|0.22
91705370|NCT01306214|183305230|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.22|-0.70|<0.0001
91727431|NCT00809146|183350062|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||||0.95|0.65|
91727432|NCT00809146|183350063|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.56||||||All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.||1.56|0.74|
91727433|NCT00809146|183350064|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.42|1.98||||||||1.98|0.42|
91727434|NCT00809146|183350065|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.3|10.7||||||||10.70|0.30|
91727435|NCT00809146|183350067|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
91727436|NCT00809146|183350068|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
91727437|NCT01049828|183350069|OTHER|The analysis is based on a threshold-free cluster enhancement permutation technique.|||||<|0.01||||||all correlations were transformed into z scores using Fisher's transformation and a t test evaluated group differences.|Fisher Exact|The analysis is based on a threshold-free cluster enhancement permutation technique.||Null hypothesis: Fisher's transform z scores for a seed region were comparable between the control and non-bothered tinnitus groups.||||<0.01
91727438|NCT03572218|183350089|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
91727439|NCT03572218|183350090|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
91727440|NCT03572218|183350091|SUPERIORITY||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.9||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.03
91727441|NCT03572218|183350091|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.02|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.02
91727442|NCT03572218|183350091|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.19
91727443|NCT03572218|183350092|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|2.1||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.11
91727444|NCT03572218|183350092|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.03
91727445|NCT03572218|183350092|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.3||0.53|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.53
91727446|NCT03572218|183350093|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
91727447|NCT03572218|183350094|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
91727448|NCT03572218|183350095|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.84|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.84
91727449|NCT03572218|183350095|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|4.0||0.82|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.82
91727450|NCT03572218|183350095|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.39|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.39
91727451|NCT03572218|183350095|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|5.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.42
91758741|NCT00360568|183410720|SUPERIORITY_OR_OTHER|||||||0.174|||||||t-test, 2 sided|||||||0.174
91696506|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.45|STANDARD_ERROR_OF_MEAN|1.94||0.02|TWO_SIDED|95.0|1.15|10.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||10.37|1.15|0.02
91727452|NCT03572218|183350095|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|4.3||0.64|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.64
91727453|NCT03572218|183350095|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.6||0.59|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.59
91727454|NCT03572218|183350096|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|3.0||0.58|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.58
91727455|NCT03572218|183350096|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.0||0.89|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.89
91727456|NCT03572218|183350096|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.7||0.9|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.90
91727457|NCT03572218|183350096|SUPERIORITY||Mean Difference (Net)|-7.1|STANDARD_ERROR_OF_MEAN|5.0||0.16|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.16
91727458|NCT03572218|183350096|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|4.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.68
91727459|NCT03572218|183350096|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|3.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.72
91727460|NCT03572218|183350097|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||0.08
91727461|NCT03572218|183350098|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|1.7||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
91727462|NCT03572218|183350099|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
91727463|NCT03572218|183350100|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|1.1||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
91727464|NCT03572218|183350101|SUPERIORITY||Mean Difference (Net)|9.7|STANDARD_ERROR_OF_MEAN|6.5||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
91528254|NCT04524598|182931785|SUPERIORITY||t|-1.911||||0.06|TWO_SIDED||||||Mixed Models Analysis|||A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction. Group and Week were entered as fixed factors. Spark version, and assessment completion days since baseline were included as fixed factors to control for effects of app version and differences in time between completion of successive weekly assessments.||||0.06
91727465|NCT03572218|183350102|SUPERIORITY||Mean Difference (Net)|12.1|STANDARD_ERROR_OF_MEAN|6.5||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||0.06
91727466|NCT03572218|183350103|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|4.4||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
91727467|NCT03572218|183350104|SUPERIORITY||Mean Difference (Net)|3.1|STANDARD_ERROR_OF_MEAN|4.4||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
91727468|NCT03572218|183350105|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.4||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
91727469|NCT03572218|183350106|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.54
91727470|NCT03572218|183350107|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.2||0.94|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.94
91727471|NCT03572218|183350107|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.6||0.64|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.64
91727472|NCT03572218|183350108|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.58|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.58
91727473|NCT03572218|183350108|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.49|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.49
91727474|NCT03572218|183350108|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.96|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.96
91727475|NCT03572218|183350108|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.71|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.71
91696507|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.45|STANDARD_ERROR_OF_MEAN|4.4||0.04|TWO_SIDED|95.0|1.12|26.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||26.53|1.12|0.04
91490617|NCT00289783|182853889|NON_INFERIORITY|Criterion for non-inferiority (42 days after the fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 1:5 dilution, in initially seronegative subjects (\< 1:5), for anti-varicella antibody is ≥ -10% (clinical limit for non-inferiority).|Difference in percentage|-0.14|||||TWO_SIDED|95.0|-0.78|1.56||||||To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).||1.56|-0.78|
91696508|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.53||0.56|TWO_SIDED|95.0|0.1|3.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.47|0.10|0.56
91696509|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.55|STANDARD_ERROR_OF_MEAN|0.44||0.46|TWO_SIDED|95.0|0.11|2.68||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.68|0.11|0.46
91696510|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|0.66||0.0002|TWO_SIDED|95.0|1.56|4.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.27|1.56|0.0002
91696511|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.48||0.0135|TWO_SIDED|95.0|1.14|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.12|1.14|0.0135
91696512|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.51|STANDARD_ERROR_OF_MEAN|0.56||0.2619|TWO_SIDED|95.0|0.73|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.12|0.73|0.2619
91705371|NCT02686814|183305246|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-0.9||||0.7646|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.7646
91705372|NCT02686814|183305246|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|3.9||||0.8984|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.8984
91490618|NCT05248867|182853949|SUPERIORITY||Rate Difference|59.3|||<|0.0001|TWO_SIDED|95.0|54.7|63.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||63.9|54.7|<0.0001
91696513|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.07|STANDARD_ERROR_OF_MEAN|0.76||0.0474|TWO_SIDED|95.0|1.01|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||4.24|1.01|0.0474
91696514|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.13|STANDARD_ERROR_OF_MEAN|0.58||0.8094|TWO_SIDED|95.0|0.42|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.07|0.42|0.8094
91696515|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.83|STANDARD_ERROR_OF_MEAN|0.6||0.7978|TWO_SIDED|95.0|0.2|3.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.44|0.20|0.7978
91696516|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.29|STANDARD_ERROR_OF_MEAN|1.15||0.1016|TWO_SIDED|95.0|0.85|6.15||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.15|0.85|0.1016
91705373|NCT02686814|183305246|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.0||||0.8457|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.8457
91705374|NCT02686814|183305246|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-7.7||||0.1309|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.1309
91727476|NCT03572218|183350108|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.41|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.41
91727477|NCT03572218|183350109|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.61|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.61
91727478|NCT03572218|183350109|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.73
91727479|NCT03572218|183350109|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.94
91727480|NCT03572218|183350109|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.47|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.47
91727481|NCT03572218|183350109|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.99
91727482|NCT03572218|183350110|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91727483|NCT03572218|183350111|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91727484|NCT03572218|183350112|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
91727485|NCT03572218|183350113|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
91727486|NCT03572218|183350114|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.83
91727487|NCT03572218|183350114|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
91727488|NCT03572218|183350114|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.30
91727489|NCT03572218|183350114|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.99
91727490|NCT03572218|183350114|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.36|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.36
91727491|NCT03572218|183350115|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.30
91727492|NCT03572218|183350115|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
91727493|NCT03572218|183350115|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.70
91727494|NCT03572218|183350115|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.26|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.26
91727495|NCT03572218|183350115|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.18
91727496|NCT03572218|183350116|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.69
91727497|NCT03572218|183350116|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.28|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.28
91727498|NCT03572218|183350116|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.02
91727499|NCT03572218|183350117|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.29|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.29
91727500|NCT03572218|183350117|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.34|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.34
91727501|NCT03572218|183350117|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|0.8||0.001|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.001
91727502|NCT03572218|183350118|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.1||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
91727503|NCT03572218|183350119|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.2||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
91490619|NCT05248867|182853950|SUPERIORITY||Rate Difference|60.2|||<|0.0001|TWO_SIDED|95.0|54.9|65.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.4|54.9|<0.0001
91490620|NCT05248867|182853951|SUPERIORITY||Rate Difference|71.4|||<|0.0001|TWO_SIDED|95.0|66.5|76.2||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.2|66.5|<0.0001
91727504|NCT03572218|183350120|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|4.8||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
91727505|NCT03572218|183350121|SUPERIORITY||Mean Difference (Net)|-10.2|STANDARD_ERROR_OF_MEAN|13.1||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
91727506|NCT03572218|183350122|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.46|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.46
91727507|NCT03572218|183350122|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.4||0.12|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.12
91727508|NCT03572218|183350122|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.42|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.42
91727509|NCT03572218|183350122|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.03
91727510|NCT03572218|183350123|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
91727511|NCT03572218|183350123|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.9|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.90
91727512|NCT03572218|183350123|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.36|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.36
91727513|NCT03572218|183350123|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.29|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.29
91727514|NCT03572218|183350124|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
91727515|NCT03572218|183350125|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|2.2||0.27|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.27
91727516|NCT03572218|183350125|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.13
91727517|NCT03572218|183350125|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.4||0.65|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.65
91727518|NCT03572218|183350126|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
91727519|NCT03572218|183350127|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7|TWO_SIDED||||||Mixed Models Analysis|||||||0.7
91727520|NCT03572218|183350128|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.8||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.2
91727521|NCT03572218|183350129|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|6.9||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
91758742|NCT00360568|183410721|SUPERIORITY_OR_OTHER|||||||0.259|||||||t-test, 2 sided|||||||0.259
91758743|NCT00360568|183410722|SUPERIORITY_OR_OTHER|||||||0.922|||||||t-test, 2 sided|||||||0.922
91758744|NCT00360568|183410723|SUPERIORITY_OR_OTHER|||||||0.258|||||||t-test, 2 sided|||||||0.258
91758745|NCT00360568|183410724|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||||||0.104
91758746|NCT00360568|183410725|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.650
91758747|NCT00360568|183410726|SUPERIORITY_OR_OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
91758748|NCT00360568|183410727|SUPERIORITY_OR_OTHER|||||||0.459|||||||t-test, 2 sided|||||||0.459
91758749|NCT00360568|183410728|SUPERIORITY_OR_OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
91727522|NCT03572218|183350130|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|3.5||0.81|TWO_SIDED||||||Mixed Models Analysis|||Total||||0.81
91727523|NCT03572218|183350130|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|4.4||0.86|TWO_SIDED||||||Mixed Models Analysis|||Physical Function||||0.86
91727524|NCT03572218|183350130|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|7.0||0.87|TWO_SIDED||||||Mixed Models Analysis|||Self Esteem||||0.87
91727525|NCT03572218|183350130|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|5.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Sexual Life||||0.73
91727526|NCT03572218|183350130|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|4.4||0.95|TWO_SIDED||||||Mixed Models Analysis|||Work||||0.95
91727527|NCT03572218|183350130|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.8||0.19|TWO_SIDED||||||Mixed Models Analysis|||Public Distress||||0.19
91727528|NCT03572218|183350131|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|4.9||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
91727529|NCT03572218|183350132|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
91727530|NCT03572218|183350133|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.5||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
91727531|NCT03572218|183350134|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.71|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.71
91727532|NCT03572218|183350134|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.72|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.72
91490621|NCT05248867|182853956|SUPERIORITY||Rate Difference|72.5|||<|0.0001|TWO_SIDED|95.0|67.4|77.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||77.6|67.4|<0.0001
91727533|NCT03572218|183350135|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
91490622|NCT05248867|182853957|SUPERIORITY||Rate Difference|41.9|||<|0.0001|TWO_SIDED|95.0|34.5|49.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||49.3|34.5|<0.0001
91727534|NCT03572218|183350136|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.52|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.52
91727535|NCT03572218|183350136|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.02
91727536|NCT03572218|183350136|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.63|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.63
91727537|NCT03572218|183350136|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.74|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.74
91490623|NCT05248867|182853958|SUPERIORITY||Rate Difference|69.5|||<|0.0001|TWO_SIDED|95.0|63.7|75.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||75.3|63.7|<0.0001
91490624|NCT05248867|182853959|SUPERIORITY||Rate Difference|58.2|||<|0.0001|TWO_SIDED|95.0|51.3|65.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.0|51.3|<0.0001
91727538|NCT03572218|183350136|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.49|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.49
91727539|NCT03572218|183350137|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
91727540|NCT03572218|183350138|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
91727541|NCT03572218|183350139|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.35|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.35
91727542|NCT03572218|183350139|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.46|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.46
91727543|NCT03572218|183350139|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.33|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.33
91727544|NCT03572218|183350139|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.18
91727545|NCT03572218|183350139|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.16|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.16
91727546|NCT03572218|183350140|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.3||0.82|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.82
91727547|NCT03572218|183350140|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.8||0.45|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.45
91727548|NCT03572218|183350140|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.007|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.007
91727549|NCT03572218|183350141|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
91727550|NCT03572218|183350141|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.48
91727551|NCT03572218|183350141|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.89|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.89
91727552|NCT03572218|183350141|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.30
91727553|NCT03572218|183350142|SUPERIORITY|||||||0.32|||||||ANOVA|||BWL component||||0.32
91727554|NCT03572218|183350143|SUPERIORITY|||||||0.14|||||||ANOVA|||||||0.14
91727555|NCT06765889|183350165|OTHER||Bayes Factor (BF₁₀)|0.03|||||TWO_SIDED|||||||||||||
91727556|NCT06765889|183350168|OTHER||Mean (of both conditions)|4.17|||||TWO_SIDED|||||||||||||
91727557|NCT02935036|183350218|SUPERIORITY||LS Mean Difference|1.33||||0.5947|TWO_SIDED||||||ANOVA|||||||0.5947
91727558|NCT02935036|183350219|SUPERIORITY||LS Mean Difference|2.75||||0.2912|TWO_SIDED||||||ANOVA|||||||0.2912
91727559|NCT02935036|183350220|SUPERIORITY||Percent difference|2.4||||0.692|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6920
91727560|NCT03606213|183350244|OTHER|||||||0.56||||||P-value week 14 versus baseline (Cohort A, arm 1; placebo)|Wilcoxon (Mann-Whitney)|||||||0.56
91727561|NCT01697501|183350258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7831|TWO_SIDED|95.0|0.29|2.57|||univariate logistic analysis|||||2.57|0.29|0.7831
91727562|NCT01697501|183350259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.1951|TWO_SIDED|95.0|0.66|7.67|||univariate logistic analysis|||||7.67|0.66|0.1951
91727563|NCT01697501|183350260|SUPERIORITY_OR_OTHER|||||||0.2642|TWO_SIDED||||||Wald Chi Square|||||||0.2642
91727564|NCT01697501|183350261|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Wald Chi Square|||||||0.0672
91727565|NCT03074643|183350324|SUPERIORITY|||||||0.16|||||||ANCOVA|Adjusted for age, sex, race||||||0.16
91727566|NCT03074643|183350324|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
91727567|NCT03074643|183350325|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for age, sex, race||||||0.81
91727568|NCT03074643|183350325|SUPERIORITY|||||||0.8|||||||ANCOVA|Adjusted for age, sex, race||||||0.80
91727569|NCT03074643|183350326|SUPERIORITY|||||||0.56|||||||ANCOVA|Adjusted for age, sex, race||||||0.56
91727570|NCT03074643|183350326|SUPERIORITY|||||||0.96|||||||ANCOVA|Adjusted for age, sex, race||||||0.96
91727571|NCT03074643|183350327|SUPERIORITY|||||||0.76|||||||ANCOVA|Adjusted for age, sex, race||||||0.76
91727572|NCT03074643|183350327|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
91727573|NCT03074643|183350328|SUPERIORITY|||||||0.75|||||||ANCOVA|Adjusted for age, sex, race||||||0.75
91727574|NCT03074643|183350328|SUPERIORITY|||||||0.95|||||||ANCOVA|Adjusted for age, sex, race||||||0.95
91727575|NCT03074643|183350329|SUPERIORITY|||||||0.06|||||||ANCOVA|Adjusted for age, sex, race||||||0.06
91727576|NCT03074643|183350329|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
91727577|NCT03074643|183350330|SUPERIORITY|||||||0.48|||||||ANCOVA|Adjusted for age, sex, race||||||0.48
91727578|NCT03074643|183350330|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
91727579|NCT00215553|183350344|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.794
91727580|NCT00215553|183350344|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.236
91727581|NCT00215553|183350344|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.396
91727582|NCT00215553|183350345|SUPERIORITY_OR_OTHER|||||||0.346||95.0|||||Cochran-Mantel-Haenszel|||||||0.346
91727583|NCT00215553|183350345|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Cochran-Mantel-Haenszel|||||||0.286
91727584|NCT00215553|183350345|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Cochran-Mantel-Haenszel|||||||0.964
91727585|NCT00215553|183350346|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|ANOVA on ranks||||||0.028
91727586|NCT00215553|183350346|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANOVA|ANOVA on ranks||||||0.147
91727587|NCT00215553|183350346|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANOVA|ANOVA on ranks||||||0.293
91727588|NCT03142334|183350347|OTHER|HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.53|0.87|||Log Rank|One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.|Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.|||0.87|0.53|0.0010
91727589|NCT02006654|183350432|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.46||0.2365|TWO_SIDED|95.0|-1.45|0.36||Corrected for multiplicity|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for idalopirdine at significance level 5%.||0.36|-1.45|0.2365
91727590|NCT02006654|183350433|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4064|TWO_SIDED|95.0|-0.09|0.23||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||0.23|-0.09|0.4064
91705375|NCT02686814|183305246|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-15.2||||0.5|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||0.5000
91705376|NCT02686814|183305247|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.5||||0.2783|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.2783
91705377|NCT02686814|183305247|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0674|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.0674
91705378|NCT02686814|183305247|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0371|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.0371
91705379|NCT02686814|183305247|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.8||||0.6953|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.6953
91705380|NCT02686814|183305247|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.0|||>|0.9999|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||>0.9999
91705381|NCT00571103|183305276|SUPERIORITY_OR_OTHER||Mean Slope|-0.985|STANDARD_ERROR_OF_MEAN|0.158||0.05|TWO_SIDED|95.0|-1.0|1.0|||Linear mixed effects|||||1|-1|0.05
91705382|NCT02368886|183305277|SUPERIORITY||Risk Difference (RD)|0.17||||0.0434|TWO_SIDED|95.0|0.0|0.34||1-sided|Fisher Exact|||||0.34|0.00|0.0434
91705383|NCT02368886|183305278|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1241|TWO_SIDED|95.0|0.47|1.1|||Log Rank|||||1.10|0.47|0.1241
91705384|NCT02368886|183305279|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3797|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3797
91705385|NCT02368886|183305280|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4614|TWO_SIDED|95.0|0.55|1.31|||Log Rank|||||1.31|0.55|0.4614
91705386|NCT02368886|183305285|SUPERIORITY|||||||0.7319|||||||Kruskal-Wallis|||||||0.7319
91705387|NCT04767529|183305287|SUPERIORITY||percent difference|22.6||||0.025|TWO_SIDED|95.0|3.8|41.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the EFX 28 mg and placebo group|% difference from placebo (efruxifermin 28 mg - placebo)|Comparison between proportion of participants in efruxifermin 28 mg group who met the primary endpoint vs the placebo group||41.4|3.8|0.025
91705388|NCT04767529|183305287|SUPERIORITY||percent difference|22.5||||0.036|TWO_SIDED|95.0|1.6|43.3||Threshold for significance was p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors is used for comparison between the EFX 50 mg and placebo group|% difference from placebo (efruxifermin 50 mg - placebo)|Comparison between proportion of participants in efruxifermin 50 mg group who met the primary endpoint vs the placebo group||43.3|1.6|0.036
91705389|NCT04767529|183305288|SUPERIORITY||percent difference|21.8||||0.07|TWO_SIDED|95.0|-1.3|45.0||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||||45.0|-1.3|0.070
91705390|NCT04767529|183305288|SUPERIORITY||percent difference|51.9|||<|0.001|TWO_SIDED|95.0|31.2|72.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||72.7|31.2|<0.001
91705391|NCT04767529|183305289|SUPERIORITY||percent difference|31.9||||0.002|TWO_SIDED|95.0|12.9|50.9||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the efruxifermin 28 mg and placebo group||Week 24||50.9|12.9|0.002
91705392|NCT04767529|183305289|SUPERIORITY||percent difference|61.7|||<|0.001|TWO_SIDED|95.0|44.1|79.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||79.4|44.1|<0.001
91705393|NCT04767529|183305289|SUPERIORITY||percent difference|38.9||||0.002|TWO_SIDED|95.0|17.2|60.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between efruxifermin 28 mg and placebo groups||Week 96||60.7|17.2|0.002
91705394|NCT04767529|183305289|SUPERIORITY||percent difference|33.2||||0.006|TWO_SIDED|95.0|10.5|55.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||55.8|10.5|0.006
91705395|NCT04767529|183305290|SUPERIORITY||percent difference|20.0||||0.053|TWO_SIDED|95.0|0.4|39.5||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||Week 24||39.5|0.4|0.053
91490625|NCT05248867|182853960|SUPERIORITY||Rate Difference|30.1|||<|0.0001|TWO_SIDED|95.0|25.2|35.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||35.1|25.2|<0.0001
91705396|NCT04767529|183305290|SUPERIORITY||percent difference|19.9||||0.069|TWO_SIDED|95.0|-1.5|41.2||Threshold for statistical significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||41.2|-1.5|0.069
91490626|NCT05248867|182853961|SUPERIORITY||Rate Difference|35.7|||<|0.0001|TWO_SIDED|95.0|30.5|40.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||40.9|30.5|<0.0001
91490627|NCT05248867|182853962|SUPERIORITY||Rate Difference|52.6|||<|0.0001|TWO_SIDED|95.0|45.2|60.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||60.0|45.2|<0.0001
91490628|NCT05248867|182853963|SUPERIORITY||Rate Difference|58.6|||<|0.0001|TWO_SIDED|95.0|51.1|66.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||66.1|51.1|<0.0001
91705397|NCT04767529|183305290|SUPERIORITY||percent difference|19.0||||0.123|TWO_SIDED|95.0|-4.8|42.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo groups||Week 96||42.8|-4.8|0.123
91696517|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.25||0.157|TWO_SIDED|95.0|0.15|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.36|0.15|0.1570
91696518|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.02|STANDARD_ERROR_OF_MEAN|1.53||0.0297|TWO_SIDED|95.0|1.11|8.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||8.18|1.11|0.0297
91705398|NCT04767529|183305290|SUPERIORITY||percent difference|49.0|||<|0.001|TWO_SIDED|95.0|27.7|70.2||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 96||70.2|27.7|<0.001
91727591|NCT02006654|183350434|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.63||0.4064|TWO_SIDED|95.0|-0.57|1.92||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||1.92|-0.57|0.4064
91727592|NCT00676689|183350460|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.971|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.889|0.993||||||||0.993|0.889|
91727593|NCT00676689|183350461|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.941|STANDARD_ERROR_OF_MEAN|0.028|||TWO_SIDED|95.0|0.851|0.978||||||Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.||0.978|0.851|
91727594|NCT00676689|183350462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.9|||||TWO_SIDED|||||||||Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.||||
91727595|NCT01487161|183350471|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.1249|TWO_SIDED|90.0|-1.2|0.2|||Longitudinal mixed effect model|||||0.2|-1.2|0.1249
91727596|NCT01487161|183350472|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2002|TWO_SIDED|90.0|-1.1|0.3|||Longitudinal mixed effect model|||||0.3|-1.1|0.2002
91727597|NCT01487161|183350473|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5541|TWO_SIDED|90.0|-0.7|0.8|||Longitudinal mixed effect model|||||0.8|-0.7|0.5541
91705399|NCT04767529|183305291|SUPERIORITY|Week 24|Mean Difference (Net)|-6.9|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-9.09|-4.71||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM: fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariate for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-4.71|-9.09|<0.001
91727598|NCT04595370|183350565|OTHER||F test statistics|1.07||||0.3645|||||||F-Test|||||||0.3645
91727599|NCT04595370|183350566|OTHER||Percent difference between treatment|-33.606||||0.1588|TWO_SIDED|95.0|-62.53|17.644|||Mixed Models Analysis|||||17.644|-62.530|0.1588
91727600|NCT04595370|183350566|OTHER||Percent difference between treatment|-11.826||||0.6846|TWO_SIDED|95.0|-52.195|62.634|||Mixed Models Analysis|||||62.634|-52.195|0.6846
91727601|NCT04595370|183350566|OTHER||Percent difference between treatment|-36.127||||0.1398|TWO_SIDED|95.0|-64.85|16.066|||Mixed Models Analysis|||||16.066|-64.850|0.1398
91727602|NCT03520387|183350572|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-10.2|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.7|-10.2|
91727603|NCT03520387|183350572|SUPERIORITY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-11.0|-1.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||-1.6|-11.0|
91727604|NCT03520387|183350573|SUPERIORITY||Mean Difference (Final Values)|-6059.0|STANDARD_ERROR_OF_MEAN|2832.7|||TWO_SIDED|95.0|-12467.0|349.1|||||This is an analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts. Positive values show increased steps with LRFA over simulated LRFA.|||349.1|-12467.0|
91696519|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.28|STANDARD_ERROR_OF_MEAN|3.81||0.0213|TWO_SIDED|95.0|1.28|21.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||21.73|1.28|0.0213
91696520|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.96|STANDARD_ERROR_OF_MEAN|0.78||0.9648|TWO_SIDED|95.0|0.2|4.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.74|0.20|0.9648
91696521|NCT04075682|183287133|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.72|STANDARD_ERROR_OF_MEAN|0.53||0.6512|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6512
91696522|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|0.66||0.41|TWO_SIDED|95.0|-0.75|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.85|-0.75|0.41
91727605|NCT03520387|183350573|SUPERIORITY||Mean Difference (Final Values)|2081.9|STANDARD_ERROR_OF_MEAN|2983.2|||TWO_SIDED|95.0|-4666.6|8830.4|||||This is an analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts.Positive values show increased steps with AcTIVE-CBT over TBSCE.|||8830.4|-4666.6|
91696523|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.67|STANDARD_ERROR_OF_MEAN|0.96||0.08|TWO_SIDED|95.0|-3.55|0.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.21|-3.55|0.08
91490629|NCT05248867|182853964|SUPERIORITY||Rate Difference|42.5|||<|0.0001|TWO_SIDED|95.0|34.4|50.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.6|34.4|<0.0001
91696524|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.95||0.55|TWO_SIDED|95.0|-2.42|1.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.29|-2.42|0.55
91696525|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.38|TWO_SIDED|95.0|-1.47|3.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||3.86|-1.47|0.38
91696526|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|1.44||0.71|TWO_SIDED|95.0|-3.35|2.28||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.28|-3.35|0.71
91696527|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.21|STANDARD_ERROR_OF_MEAN|1.34||0.02|TWO_SIDED|95.0|0.59|5.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.83|0.59|0.02
91705400|NCT04767529|183305291|SUPERIORITY|Week 24|Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-11.47|-7.02||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-7.02|-11.47|<0.001
91705401|NCT04767529|183305291|SUPERIORITY|Week 96|Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.31||0.005|TWO_SIDED|95.0|-6.39|-1.18||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-1.18|-6.39|0.005
91705402|NCT04767529|183305291|SUPERIORITY|Week 96|Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-8.38|-3.25||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-3.25|-8.38|<0.001
91705403|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|-51.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-71.17|-32.11|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-32.11|-71.17|<0.001
91705404|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|-55.2|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-74.63|-35.71|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-35.71|-74.63|<0.001
91727606|NCT03520387|183350574|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.2|3.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.1|-5.2|
91727607|NCT03520387|183350574|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.2|3.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||3.6|-4.2|
91727608|NCT03520387|183350575|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.1|10.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS physical health scores||10.1|-8.1|
91727609|NCT03520387|183350575|SUPERIORITY||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-0.4|12.9|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS physical health scores||12.9|-0.4|
91727610|NCT03520387|183350575|SUPERIORITY||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|12.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS mental health scores||12.7|-5.4|
91727611|NCT03520387|183350575|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-7.0|10.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS mental health scores||10.6|-7.0|
91727612|NCT03520387|183350576|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-7.7|1.9|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with LRFA over simulated LRFA.|||1.9|-7.7|
91727613|NCT03520387|183350576|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-7.5|1.0|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with AcTIVE-CBT over TBSCE.|||1.0|-7.5|
91727614|NCT03520387|183350577|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.4|1.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate perceived benefit with LRFA over simulated LRFA.|||1.7|-1.4|
91727615|NCT03520387|183350577|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.3|1.5|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Positive scores indicate perceived benefit with AcTIVE-CBT over TBSCE.|||1.5|-1.3|
91727616|NCT03520387|183350578|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-5.5|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with LRFA over simulated LRFA.|||3.7|-5.5|
91727617|NCT03520387|183350578|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.4|2.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with AcTIVE-CBT vs. TBSCE|||2.6|-5.4|
91727618|NCT03520387|183350579|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.5|3.0|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with LRFA over simulated LRFA.|||3.0|-0.5|
91727619|NCT03520387|183350579|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.4|2.8|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||2.8|-0.4|
91727620|NCT03520387|183350580|SUPERIORITY||Mean Difference (Final Values)|-637.0|STANDARD_ERROR_OF_MEAN|433.3|||TWO_SIDED|95.0|-1636.2|362.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate greater activity with LRFA over simulated LRFA.|||362.1|-1636.2|
91727621|NCT03520387|183350580|SUPERIORITY||Mean Difference (Final Values)|572.2|STANDARD_ERROR_OF_MEAN|334.5|||TWO_SIDED|95.0|-199.3|1343.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||1343.6|-199.3|
91727622|NCT00541775|183350581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<=|0.001||95.0|-0.7|-0.32|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-0.32|-0.70|<=0.001
91727623|NCT00541775|183350582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|5.0|<=|0.001||95.0|-27.6|-8.1|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-8.1|-27.6|<=0.001
91696528|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|1.94||0.98|TWO_SIDED|95.0|-3.85|3.76||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.76|-3.85|0.98
91696529|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.13|STANDARD_ERROR_OF_MEAN|2.08||0.31|TWO_SIDED|95.0|-6.2|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.95|-6.2|0.31
91696530|NCT04075682|183287134|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.93||0.68|TWO_SIDED|95.0|-4.58|2.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.97|-4.58|0.68
91696531|NCT04075682|183287135|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED|95.0|-0.81|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.81|0.45
91696532|NCT04075682|183287135|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.25||0.5767|TWO_SIDED|95.0|-0.64|0.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.70|-0.64|0.5767
91705405|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|-43.0|STANDARD_ERROR_OF_MEAN|11.48|<|0.001|TWO_SIDED|95.0|-65.73|-20.27||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-20.27|-65.73|<0.001
91727624|NCT00541775|183350583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.5|STANDARD_ERROR_OF_MEAN|7.9|<=|0.001||95.0|-46.0|-15.0|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-15.0|-46.0|<=0.001
91727625|NCT04913675|183350591|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM dose versus 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A post-hoc weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|1.06|||||TWO_SIDED|95.0|-1.15|3.26|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.26|-1.15|
91727626|NCT04913675|183350591|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM vs 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A pre-specified daily imputation algorithm imputed the missing outcome iteratively for each study day starting with Day 2 and ending at Day 29.|Risk Difference (RD)|1.16|||||TWO_SIDED|95.0|-1.23|3.56|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.56|-1.23|
91727627|NCT04913675|183350609|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of IM dose versus IV using a non-inferiority margin of 3.5% on the risk difference scale. Weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|-1.56|3.28|||||Post-hoc analysis was performed using a binomial regression model with identify link function and with treatment (Sotrovimab 500 mg IM, 500 mg IV), age (\<65, \>-65 years old), and sex (male, female) as covariates.|||3.28|-1.56|
91727628|NCT04913675|183350612|EQUIVALENCE|IM dose was assessed for equivalence to IV based on the two-sided 90% confidence interval for the treatment ratio falling within equivalence bounds of 0.5 to 2.0.|Ratio of least square(LS) geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.07|||||LS geometric mean was calculated for 500mg IV versus IM by using an Analysis of Covariance (ANCOVA) Model with treatment group (sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old), gender (male, female) and Baseline viral load as covariates.|||1.07|1.00|
91727629|NCT05181657|183350661|OTHER|The intervention effect was determined via a two sided, 0.05 level of significance, multivariable Poisson regression model, with Intervention group as the primary predictor.|Risk Ratio (RR)|1.45|||<|0.05|TWO_SIDED|95.0|1.18|1.78||"Alpha significance levels used:~For the primary predictor (i.e., intervention group): alpha=0.05; For covariates: alpha=0.10; For interactions: alpha=0.15"|Poisson Regression||The estimate refers to the relative risk of getting a COVID-19 test onsite (Intervention/Control). Also, the above estimate is from the unadjusted Poisson regression model (i.e., model not adjusted for covariates and interactions).|To assess whether the active intervention was more successful than the control condition at increasing COVID-19 testing, we used univariable and multivariable Poisson regression models, with whether one received onsite testing right after the intervention as the outcome and intervention group as the main predictor. Potential clustering due to the randomization by week was accounted for by specifying an exchangeable correlation structure for participants who were recruited during the same week.||1.78|1.18|<0.05
91727630|NCT00694122|183350663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|277.9|STANDARD_ERROR_OF_MEAN|164.9|<|0.05|TWO_SIDED|95.0|-75.9|631.6|||t-test, 2 sided|No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.|The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).|||631.6|-75.9|<0.05
91727631|NCT00694122|183350664|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91727632|NCT00694122|183350668|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91727633|NCT00063232|183350673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||paired t-test|||"self-controlled comparison of NASH activity index at 48 weeks and baseline. Null hypothesis is no change."||||<0.001
91727634|NCT00063232|183350674|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||self-controlled comparison of serum aminotransferase levels at 48 weeks and baseline. Null hypothesis: No change||||0.04
91727635|NCT00063232|183350675|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||paired t-test|||||||0.04
91727636|NCT03339453|183350676|NON_INFERIORITY|95% Confidence Interval of the treatment differences in treatment success rate.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.52|1.52||||||||1.52|-1.52|
91727637|NCT03632720|183350697|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95 percent (%) confidence interval (CI) was greater (\>) -10% for all four serogroups.|Difference in Percentage|0.64|||||TWO_SIDED|95.0|-1.78|3.54||||||Serogroup A||3.54|-1.78|
91727638|NCT03632720|183350697|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.24|2.28||||||Serogroup C||2.28|-2.24|
91727639|NCT03632720|183350697|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.33|2.36||||||Serogroup Y||2.36|-2.33|
91727640|NCT03632720|183350697|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|-0.58|||||TWO_SIDED|95.0|-3.22|1.81||||||Serogroup W||1.81|-3.22|
91727641|NCT03834883|183350745|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
91727642|NCT03834883|183350746|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
91727643|NCT03834883|183350747|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
91727644|NCT03834883|183350748|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91727645|NCT03834883|183350749|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91727646|NCT03834883|183350750|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91727647|NCT03834883|183350752|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
91727648|NCT03834883|183350753|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
91727649|NCT03834883|183350754|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
91727650|NCT03834883|183350755|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||0.83
91727651|NCT03834883|183350756|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91727652|NCT03738215|183350758|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.005|TWO_SIDED|95.0|-4.17|-0.89||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.89|-4.17|0.0050
91727653|NCT03738215|183350758|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0727|TWO_SIDED|95.0|-3.16|0.12||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||0.12|-3.16|0.0727
91696533|NCT04075682|183287136|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.98|0.36
91696534|NCT04075682|183287136|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.67||0.63|TWO_SIDED|95.0|-1.64|0.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||0.99|-1.64|0.63
91696535|NCT04075682|183287136|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.79|TWO_SIDED|95.0|-1.62|2.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.12|-1.62|0.79
91727654|NCT03738215|183350759|SUPERIORITY||Lease Squares Mean Difference|-0.3||||0.0727|TWO_SIDED|95.0|-0.49|-0.07||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.07|-0.49|0.0727
91727655|NCT03738215|183350759|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0944|TWO_SIDED|95.0|-0.39|0.03||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures.||||0.03|-0.39|0.0944
91727656|NCT03211858|183350762|NON_INFERIORITY|Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was \<0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was \> -0.3%.|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.192|0.039|||||SAR341402 vs NovoLog/NovoRapid|Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.||0.039|-0.192|
91727657|NCT00004228|183350780|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 (A: CCG BFM) to regimens B1+B2 (B: NHL/BFM-95) while adjusting for the other intervention through stratification."||||.97
91727658|NCT00004228|183350780|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 (1: no intensification) to A2 +B2 (2: intensification), while adjusting for the other intervention through stratification."||||.63
91727659|NCT01934231|183350803|SUPERIORITY_OR_OTHER||Rate of Cure|88.5|||||TWO_SIDED|95.0|69.85|97.55|||||"The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of Cure/number of participants analyzed) \* 100."|||97.55|69.85|
91727660|NCT02457546|183350809|NON_INFERIORITY|"The statistical hypothesis for testing the treatment difference was presented as follows:~H0: Δ ≤ -0.10 tested against the alternative hypothesis Ha: Δ \> -0.10. where:~* Δ is the difference between the success rates of Experimental (Evicel®) and Control (DuraSeal™) (Experimental minus Control)~* -0.10 is the non-inferiority difference PC is the proportion of success in DuraSeal™ Control subjects and PE is the proportion of success in EVICEL® subjects."|Difference in Success Rates|6.3|||||TWO_SIDED|95.0|-1.8|14.4||||||||14.4|-1.8|
91727661|NCT01750281|183350859|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.12||||0.584|TWO_SIDED|90.0|0.8|1.61|||Cox Proportional Hazards|||||1.61|0.80|0.584
91727662|NCT01750281|183350859|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|0.92||||0.69|TWO_SIDED|90.0|0.65|1.31|||Cox Proportional Hazards|||||1.31|0.65|0.690
91727663|NCT01750281|183350860|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.43||||0.126|TWO_SIDED|90.0|0.97|2.13|||Cox Proportional Hazards|||||2.13|0.97|0.126
91727664|NCT01750281|183350860|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.18||||0.485|TWO_SIDED|90.0|0.8|1.78|||Cox Proportional Hazards|||||1.78|0.80|0.485
91727665|NCT00564070|183350918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.2|||<|0.0001|TWO_SIDED|95.0|17.37|42.9|||Mixed Models Analysis|General linear model, controlling for baseline values|The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.|Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)||42.9|17.37|<.0001
91490630|NCT05248867|182853965|SUPERIORITY||Rate Difference|70.0|||<|0.0001|TWO_SIDED|95.0|63.7|76.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.3|63.7|<0.0001
91490631|NCT05248867|182853973|SUPERIORITY||Rate Difference|48.8|||<|0.0001|TWO_SIDED|95.0|42.2|55.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||55.4|42.2|<0.0001
91490632|NCT05248867|182853974|SUPERIORITY||Rate Difference|44.2|||<|0.0001|TWO_SIDED|95.0|38.0|50.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.4|38.0|<0.0001
91490633|NCT03128411|182853991|SUPERIORITY||||||<|0.0001|||||||z-test, 1-sided|||With a sample size of 60 participants, study was powered at \>82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.||||<0.0001
91490634|NCT00345839|182854028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||p-value\<0.044 considered significant|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.112
91490635|NCT00345839|182854028|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.85|1.02|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.02|0.85|
91490636|NCT00345839|182854029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.249
91727666|NCT00564070|183350919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||=|0.001|TWO_SIDED|95.0|0.29|1.15|||ANCOVA|General linear model; Controlling for baseline values|The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.|Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)||1.15|.29|=.001
91490637|NCT00345839|182854029|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.04|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.04|0.85|
91490638|NCT00345839|182854030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.800
91490639|NCT00345839|182854030|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.19|0.79|
91490640|NCT00345839|182854031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.283
91490641|NCT00345839|182854031|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.58|1.18|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.18|0.58|
91490642|NCT00345839|182854032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.034
91490643|NCT00345839|182854032|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.68|0.99|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.99|0.68|
91490644|NCT00345839|182854033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.190
91490645|NCT00345839|182854033|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.72|
91727667|NCT00564070|183350920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.22|31.14|||Mixed Models Analysis||The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.||31.14|10.22|<0.0001
91490646|NCT00345839|182854034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.277
91490647|NCT00345839|182854034|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.80|
91490648|NCT00345839|182854035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.607
91490649|NCT00345839|182854035|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.40|0.82|
91490650|NCT00345839|182854036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.218
91490651|NCT00345839|182854036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.75|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.75|
91490652|NCT00345839|182854037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||<0.001
91727668|NCT00564070|183350921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||=|0.002|TWO_SIDED|95.0|2.33|10.56|||Mixed Models Analysis|General linear model, controlling for baseline values.|The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.||10.56|2.33|=.002
91727669|NCT00564070|183350922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||=|0.01|TWO_SIDED|95.0|0.16|1.32|||ANCOVA|using GLM|The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.|||1.32|.16|=.01
91727670|NCT00564070|183350923|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|22.3|STANDARD_ERROR_OF_MEAN|7.0|=|0.002|TWO_SIDED|95.0|8.6|36.1|||Mixed Models Analysis|||We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU||36.1|8.6|=.002
91727671|NCT00564070|183350924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|5.0|=|0.001|TWO_SIDED|95.0|6.5|26.1|||Mixed Models Analysis|||We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU||26.1|6.5|=.001
91727672|NCT00564070|183350925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.1||0.16|TWO_SIDED|95.0|-1.2|7.2|||Mixed Models Analysis|||We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.||7.2|-1.2|.16
91490653|NCT00345839|182854037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.36|0.54|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.54|0.36|
91727673|NCT00564070|183350926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm||1.1|-.1|.10
91727674|NCT00564070|183350927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.29||0.03|TWO_SIDED|95.0|0.6|1.2|||Mixed Models Analysis|||We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.||1.2|.6|.03
91727675|NCT01655069|183350943|OTHER||Adjusted change from baseline|-0.95|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.19|-0.71|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.71|-1.19|
91727676|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.34|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-1.34|
91727677|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.26|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.53|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-1.53|
91727678|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.39|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.63|-1.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.16|-1.63|
91727679|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.54|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-1.76|-1.32|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.32|-1.76|
91727680|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.56|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.81|-1.31|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.31|-1.81|
91727681|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.93|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.19|-1.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.67|-2.19|
91727682|NCT01655069|183350943|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.62|-0.23|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.23|-1.62|
91727683|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.38|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.09|-0.68|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.68|-2.09|
91727684|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.09|-0.7|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.70|-2.09|
91727685|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.58|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.27|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-2.27|
91727686|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.8|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.5|-1.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.10|-2.50|
91727687|NCT01655069|183350943|OTHER||Adjusted change from baseline|-1.57|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.29|-0.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.85|-2.29|
91727688|NCT01655069|183350943|OTHER||Adjusted change from baseline|-2.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.83|-1.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.17|-2.83|
91727689|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.35|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.97|1.73|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.73|0.97|
91727690|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.43|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.02|1.83|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.83|1.02|
91727691|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.72|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.27|2.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.16|1.27|
91727692|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.8|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.36|2.24|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.24|1.36|
91727693|NCT01655069|183350944|OTHER||Adjusted change from baseline|2.21|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|1.74|2.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.67|1.74|
91727694|NCT01655069|183350944|OTHER||Adjusted change from baseline|2.28|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|1.79|2.77|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.77|1.79|
91727695|NCT01655069|183350944|OTHER||Adjusted change from baseline|2.84|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|2.19|3.49|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.49|2.19|
91490654|NCT01960400|182854053|SUPERIORITY_OR_OTHER|||||||0.065||||||"The statistical signifiance level : p\<0.05. After treatment (T1) Pain severity p=0.065~Sub-scale:~* Present pain p=0.046\*~* Average pain p=0.381~* Most intense pain p=0.064~* Least intense pain p=0.142"|ANOVA|To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.||For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).||||0.065
91490655|NCT01960400|182854054|SUPERIORITY_OR_OTHER|||||||0.049||||||interaction group X time|ANOVA|||||||0.049
91696536|NCT04075682|183287136|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.31||0.4491|TWO_SIDED|95.0|-0.84|0.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.37|-0.84|0.4491
91696537|NCT04075682|183287136|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8713|TWO_SIDED|95.0|-1.26|1.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.06|-1.26|0.8713
91696538|NCT04075682|183287136|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.85||0.99|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.66|-1.66|0.99
91696539|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.34||0.04|TWO_SIDED|95.0|0.02|1.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.37|0.02|0.04
91696540|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.85|0.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.11|-1.85|0.08
91705406|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|-47.8|STANDARD_ERROR_OF_MEAN|11.4|<|0.001|TWO_SIDED|95.0|-70.39|-25.24||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-25.24|-70.39|<0.001
91727696|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.53|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.17|2.89|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.89|0.17|
91758750|NCT02611817|183410770|SUPERIORITY||Clopper-Pearson method|13.7||||0.008|TWO_SIDED|95.0|3.8|23.7|||Cochran-Mantel-Haenszel|||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by electronic data capture (EDC) stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||23.7|3.8|0.008
91490656|NCT01960400|182854055|SUPERIORITY_OR_OTHER|||||||0.035||||||interaction group X time|ANOVA|||||||0.035
91490657|NCT01960400|182854056|SUPERIORITY_OR_OTHER|||||||0.046||||||interaction group X time|ANOVA|||||||0.046
91696541|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.49||0.65|TWO_SIDED|95.0|-0.74|1.19||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.19|-0.74|0.65
91696542|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.71||0.3|TWO_SIDED|95.0|-0.66|2.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.11|-0.66|0.30
91696543|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.75||0.78|TWO_SIDED|95.0|-1.68|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.26|-1.68|0.78
91696544|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|0.69||0.03|TWO_SIDED|95.0|0.12|2.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.83|0.12|0.03
91696545|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|-1.92|2.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.04|-1.92|0.95
91696546|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.09||0.48|TWO_SIDED|95.0|-2.91|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|-2.91|0.48
91696547|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.37|TWO_SIDED|95.0|-2.86|1.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.07|-2.86|0.37
91727697|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.9|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|0.52|3.27|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.27|0.52|
91727698|NCT01655069|183350944|OTHER||Adjusted change from baseline|1.75|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.39|3.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.10|0.39|
91727699|NCT01655069|183350944|OTHER||Adjusted change from baseline|2.69|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.34|4.05|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.05|1.34|
91727700|NCT01655069|183350944|OTHER||Adjusted change from baseline|3.07|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.7|4.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.43|1.70|
91727701|NCT01655069|183350944|OTHER||Adjusted change from baseline|2.45|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|1.05|3.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.85|1.05|
91727702|NCT01655069|183350944|OTHER||Adjusted change from baseline|3.93|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|2.34|5.53|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||5.53|2.34|
91727703|NCT01655069|183350945|OTHER||Adjusted change from baseline|-0.98|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.27|-0.69|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.69|-1.27|
91727704|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.44|-0.86|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.86|-1.44|
91727705|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.31|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.6|-1.02|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.02|-1.60|
91727706|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.22|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.51|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.93|-1.51|
91727707|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.5|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.8|-1.21|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.21|-1.80|
91727708|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.52|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-1.83|-1.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.22|-1.83|
91727709|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.83|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-2.22|-1.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.43|-2.22|
91727710|NCT01655069|183350945|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.73|-0.13|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.13|-1.73|
91727711|NCT01655069|183350945|OTHER||Adjusted change from baseline|-0.94|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.48|-0.4|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.40|-1.48|
91727712|NCT01655069|183350945|OTHER||Adjusted change from baseline|-0.81|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.46|-0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.17|-1.46|
91727713|NCT01655069|183350945|OTHER||Adjusted change from baseline|-0.91|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.53|-0.28|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.28|-1.53|
91727714|NCT01655069|183350945|OTHER||Adjusted change from baseline|-0.71|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.8|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-1.80|
91727715|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.18|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.92|-0.44|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.44|-1.92|
91727716|NCT01655069|183350945|OTHER||Adjusted change from baseline|-1.79|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.59|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.59|
91727717|NCT01655069|183350946|OTHER||Adjusted change from baseline|-0.74|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.65|0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||0.17|-1.65|
91727718|NCT01655069|183350946|OTHER||Adjusted change from baseline|-1.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.23|-0.36|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.36|-2.23|
91727719|NCT01655069|183350946|OTHER||Adjusted change from baseline|-1.14|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.06|-0.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.22|-2.06|
91528255|NCT04524598|182931785|SUPERIORITY||t|-2.546||||0.01|TWO_SIDED||||||Mixed Models Analysis|||We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction.||||0.01
91528256|NCT04524598|182931788|SUPERIORITY||F|1.46||||0.23|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on GAD-7 scores to compare the change in anxiety symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.23
91528257|NCT04524598|182931788|SUPERIORITY||F|2.59||||0.11|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS - General Health Score to compare the change in general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.11
91528258|NCT04524598|182931789|SUPERIORITY||F|0.94||||0.33|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Time x Group) on the MFQ to compare the change in parent report of depressive symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.33
91696548|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.31||0.0192|TWO_SIDED|95.0|0.12|1.34||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.34|0.12|0.0192
91696549|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.45||0.186|TWO_SIDED|95.0|-1.48|0.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.29|-1.48|0.1860
91705407|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|11.0|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|7.92|14.17|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||14.17|7.92|<0.001
91758751|NCT02611817|183410771|SUPERIORITY||Clopper-Pearson method|7.3||||0.167|TWO_SIDED|95.0|-3.0|17.5|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||17.5|-3.0|0.167
91528259|NCT04524598|182931789|SUPERIORITY||F|0.02||||0.9|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS Parent Proxy - General Health Score to compare the change in parent reported general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.90
91528260|NCT02306122|182931793|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.034|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
91528261|NCT02306122|182931793|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.041|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
91528262|NCT02306122|182931793|SUPERIORITY||Risk Difference (RD)|0.012|STANDARD_ERROR_OF_MEAN|0.029|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
91528263|NCT02306122|182931794|SUPERIORITY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|2.523|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
91705408|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|12.5|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|9.35|15.57|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||15.57|9.35|<0.001
91705409|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|2.12||0.005|TWO_SIDED|95.0|1.84|10.23||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||10.23|1.84|0.005
91758752|NCT02611817|183410772|SUPERIORITY||Clopper-Pearson method|27.1||||0.002|TWO_SIDED|95.0|11.9|42.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||42.3|11.9|0.002
91528264|NCT02306122|182931794|SUPERIORITY||Mean Difference (Final Values)|-1.582|STANDARD_ERROR_OF_MEAN|2.997|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
91528265|NCT02306122|182931794|SUPERIORITY||Mean Difference (Final Values)|0.308|STANDARD_ERROR_OF_MEAN|2.38|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
91528266|NCT02306122|182931795|SUPERIORITY||Risk Difference (RD)|-0.043|STANDARD_ERROR_OF_MEAN|0.068|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
91528267|NCT02306122|182931795|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.063|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
91727720|NCT01655069|183350946|OTHER||Adjusted change from baseline|-1.28|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.18|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-2.18|
91727721|NCT01655069|183350946|OTHER||Adjusted change from baseline|-1.04|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.95|-0.12|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.12|-1.95|
91727722|NCT01655069|183350946|OTHER||Adjusted change from baseline|-1.96|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.93|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.93|
91727723|NCT01655069|183350946|OTHER||Adjusted change from baseline|-2.2|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.48|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.93|-3.48|
91727724|NCT00835042|183350948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.5||||||90.0|85.8|99.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||99.8|85.8|
91727725|NCT00835042|183350949|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|92.2|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.2|
91727726|NCT00835042|183350950|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|92.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.3|
91727727|NCT00835042|183350951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|99.3|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|99.3|
91727728|NCT00835042|183350952|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|96.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.4|
91727729|NCT00835042|183350953|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|96.7|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.7|
91727730|NCT00835042|183350954|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.0||||||90.0|81.8|101.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101|81.8|
91727731|NCT00835042|183350955|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|94.6|103.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103|94.6|
91727732|NCT00835042|183350956|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.6|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|97.6|
91727733|NCT02571244|183350977|SUPERIORITY||Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.99|1.85||||||||1.85|0.99|
91727734|NCT02571244|183350978|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
91727735|NCT02571244|183350979|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
91727736|NCT02571244|183350980|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.08|1.95||||||||1.95|1.08|
91727737|NCT02571244|183350981|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|1.07|1.92||||||||1.92|1.07|
91727738|NCT00185900|183350982|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91727739|NCT02362412|183351096|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-3.4|2.3||p-value was not adjusted|||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||2.3|-3.4|
91727740|NCT02362412|183351097|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-1.7|1.9|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||1.9|-1.7|
91727741|NCT02362412|183351098|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
91727742|NCT02362412|183351099|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
91727743|NCT02362412|183351101|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
91727744|NCT02362412|183351102|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
91727745|NCT02057666|183351196|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.406||||0.027|TWO_SIDED|95.0|0.182|0.903|||Log Rank|Stratified as per randomisation.|Stratified as per randomisation.|||0.903|0.182|0.027
91727746|NCT02057666|183351197|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.465||||0.448|TWO_SIDED|95.0|0.065|3.355|||Log Rank|||||3.355|0.065|0.448
91727747|NCT01348490|183351206|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.025||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0250
91727748|NCT01348490|183351206|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.0163||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0163
91727749|NCT01348490|183351206|OTHER|1-sample t-test with null hypothesis mean \>= 0|||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
91727750|NCT01348490|183351206|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.2019||||||1-sample t-test was used.|t-test, 1 sided|||||||0.2019
91727751|NCT01348490|183351207|OTHER|||||||0.6887||||||1-sample t-test was used.|t-test, 1 sided|||||||0.6887
91727752|NCT01348490|183351207|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
91727753|NCT01348490|183351207|OTHER|||||||0.8701||||||1-sample t-test was used.|t-test, 1 sided|||||||0.8701
91727754|NCT01348490|183351211|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
91727755|NCT01348490|183351212|OTHER|||||||0.0028||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0028
91727756|NCT00286455|183351230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.76|-0.31||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.31|-0.76|<0.001
91727757|NCT00286455|183351230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.35|||ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.35|-0.80|<0.001
91727758|NCT00286455|183351231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.14|-0.39|<0.001
91727759|NCT00286455|183351231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.46|-0.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.46|<0.001
91727760|NCT00286455|183351232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.23|-0.57|<0.001
91727761|NCT00286455|183351232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
91727762|NCT00286455|183351233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.63|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.63|<0.001
91727763|NCT00286455|183351233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.73|-0.35||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.35|-0.73|<0.001
91727764|NCT00286455|183351234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.68|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.68|<0.001
91727765|NCT00286455|183351234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.74|<0.001
91727766|NCT00286455|183351235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.67|<0.001
91727767|NCT00286455|183351235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.70|<0.001
91727768|NCT00286455|183351236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2||||0.002|TWO_SIDED|95.0|-21.5|-5.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-21.5|0.002
91727769|NCT00286455|183351236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.0|-10.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.4|-27.0|<0.001
91727770|NCT00286455|183351237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-26.7|-10.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.1|-26.7|<0.001
91727771|NCT00286455|183351237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|||<|0.001|TWO_SIDED|95.0|-29.7|-13.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.0|-29.7|<0.001
91727772|NCT00286455|183351238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-27.1|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-27.1|<0.001
91727773|NCT00286455|183351238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-33.2|-15.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.7|-33.2|<0.001
91727774|NCT00286455|183351239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7||||0.001|TWO_SIDED|95.0|-26.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-26.8|0.001
91727775|NCT00286455|183351239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.3|||<|0.001|TWO_SIDED|95.0|-32.4|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-32.4|<0.001
91490658|NCT04547712|182854057|SUPERIORITY||Proportion expressed as a percentage|78.9|||||ONE_SIDED|97.5|59.4||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \> 50%"|||59.4|
91528268|NCT02306122|182931796|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.071|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the choice arm|||||<0.01
91696550|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.44||0.3863|TWO_SIDED|95.0|-0.49|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.26|-0.49|0.3863
91696551|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.571|TWO_SIDED|95.0|-0.89|1.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.61|-0.89|0.5710
91696552|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.68||0.2797|TWO_SIDED|95.0|-2.06|0.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.60|-2.06|0.2797
91727776|NCT00286455|183351240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5||||0.002|TWO_SIDED|95.0|-26.8|-6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.2|-26.8|0.002
91727777|NCT00286455|183351240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||<|0.001|TWO_SIDED|95.0|-31.6|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-31.6|<0.001
91727778|NCT00286455|183351241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||<|0.001|TWO_SIDED|95.0|-30.9|-8.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-30.9|<0.001
91727779|NCT00286455|183351241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||<|0.001|TWO_SIDED|95.0|-34.6|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-34.6|<0.001
91727780|NCT00286455|183351242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-30.6|-8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-30.6|<0.001
91727781|NCT00286455|183351242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED|95.0|-35.7|-12.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.9|-35.7|<0.001
91727782|NCT00286455|183351243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||<|0.001|TWO_SIDED|95.0|-34.1|-9.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.0|-34.1|<0.001
91727783|NCT00286455|183351243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|||<|0.001|TWO_SIDED|95.0|-40.4|-15.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.1|-40.4|<0.001
91727784|NCT00286455|183351244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.569||||0.165|TWO_SIDED|95.0|0.257|1.262|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.262|0.257|0.165
91727785|NCT00286455|183351244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.008|TWO_SIDED|95.0|0.138|0.739|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.739|0.138|0.008
91727786|NCT00286455|183351245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.194||||0.001|TWO_SIDED|95.0|0.073|0.516|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.516|0.073|0.001
91727787|NCT00286455|183351245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.145|||<|0.001|TWO_SIDED|95.0|0.052|0.405|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.405|0.052|<0.001
91528269|NCT00180713|182931797|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
91696553|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.62||0.0312|TWO_SIDED|95.0|0.12|2.55||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.55|0.12|0.0312
91696554|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.5086|TWO_SIDED|95.0|-1.19|2.39||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.39|-1.19|0.5086
91696555|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.98||0.9474|TWO_SIDED|95.0|-1.86|1.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.99|-1.86|0.9474
91696556|NCT04075682|183287137|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.5018|TWO_SIDED|95.0|-2.36|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.16|-2.36|0.5018
91696557|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.39||0.25|TWO_SIDED|95.0|-0.31|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.31|0.25
91727788|NCT00286455|183351246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.056|TWO_SIDED|95.0|-15.3|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.2|-15.3|0.056
91727789|NCT00286455|183351246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3|||<|0.001|TWO_SIDED|95.0|-21.1|-5.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-21.1|<0.001
91727790|NCT00286455|183351247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.85|TWO_SIDED|95.0|-7.8|9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.4|-7.8|0.850
91727791|NCT00286455|183351247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.571|TWO_SIDED|95.0|-6.2|11.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||11.2|-6.2|0.571
91727792|NCT00286455|183351248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.917|TWO_SIDED|95.0|-7.8|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-7.8|0.917
91727793|NCT00286455|183351248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.133|TWO_SIDED|95.0|-13.2|1.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.7|-13.2|0.133
91727794|NCT00286455|183351249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.348|TWO_SIDED|95.0|-12.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-12.1|0.348
91727795|NCT00286455|183351249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.152|TWO_SIDED|95.0|-14.3|2.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.2|-14.3|0.152
91727796|NCT00286455|183351250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.12|TWO_SIDED|95.0|-11.7|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-11.7|0.120
91727797|NCT00286455|183351250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5||||0.104|TWO_SIDED|95.0|-12.1|1.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.1|-12.1|0.104
91727798|NCT00286455|183351251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.247|TWO_SIDED|95.0|-10.9|2.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.8|-10.9|0.247
91727799|NCT00286455|183351251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.129|TWO_SIDED|95.0|-12.3|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-12.3|0.129
91727800|NCT00286455|183351252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.671|TWO_SIDED|95.0|-4.14|2.67||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.67|-4.14|0.671
91727801|NCT00286455|183351252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.218|TWO_SIDED|95.0|-5.57|1.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.27|-5.57|0.218
91727802|NCT00286455|183351253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.403|TWO_SIDED|95.0|-2.07|5.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.14|-2.07|0.403
91727803|NCT00286455|183351253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.487|TWO_SIDED|95.0|-2.35|4.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.93|-2.35|0.487
91727804|NCT00286455|183351254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.143|TWO_SIDED|95.0|-0.88|6.08||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.08|-0.88|0.143
91727805|NCT00286455|183351254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.974|TWO_SIDED|95.0|-3.46|3.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.57|-3.46|0.974
91727806|NCT00286455|183351255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.612|TWO_SIDED|95.0|-2.78|4.71||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.71|-2.78|0.612
91727807|NCT00286455|183351255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.587|TWO_SIDED|95.0|-4.82|2.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.74|-4.82|0.587
91727808|NCT00286455|183351256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.514|TWO_SIDED|95.0|-2.0|3.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.99|-2.00|0.514
91727809|NCT00286455|183351256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.899|TWO_SIDED|95.0|-2.83|3.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.22|-2.83|0.899
91727810|NCT00286455|183351257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.885|TWO_SIDED|95.0|-3.09|3.58||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.58|-3.09|0.885
91727811|NCT00286455|183351257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.958|TWO_SIDED|95.0|-3.28|3.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.46|-3.28|0.958
91727812|NCT00286455|183351258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.003|TWO_SIDED|95.0|-0.084|-0.018||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.018|-0.084|0.003
91727813|NCT00286455|183351258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.072|||<|0.001|TWO_SIDED|95.0|-0.105|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.105|<0.001
91490659|NCT04547712|182854057|SUPERIORITY||Proportion expressed as a percentage|91.0|||||ONE_SIDED|97.5|75.6||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \> 50%"|||75.6|
91490660|NCT04547712|182854058|SUPERIORITY|||||||0.012||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0120
91490661|NCT04547712|182854058|SUPERIORITY|||||||0.0491||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0491
91490662|NCT05544734|182854060|SUPERIORITY||Median Difference (Final Values)|-0.3||||0.69|TWO_SIDED|95.0|-1.85|1.25|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).|||1.25|-1.85|0.69
91490663|NCT05544734|182854061|SUPERIORITY||Median Difference (Final Values)|2.3||||0.62|TWO_SIDED|95.0|-7.25|11.85|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6) minus Non-Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6).|||11.85|-7.25|0.62
91490664|NCT03298867|182854067|SUPERIORITY||Stratified difference in percentages|73.45|STANDARD_ERROR_OF_MEAN|7.43|<|0.001|TWO_SIDED|95.0|58.89|88.01||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||88.01|58.89|<0.001
91490665|NCT03298867|182854068|SUPERIORITY||Stratified difference in percentages|70.82|STANDARD_ERROR_OF_MEAN|7.62|<|0.001|TWO_SIDED|95.0|55.89|85.75||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||85.75|55.89|<0.001
91528270|NCT00180713|182931798|SUPERIORITY|||||||0.86|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.86
91528271|NCT00180713|182931799|SUPERIORITY|||||||0.4|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.4
91528272|NCT00180713|182931800|SUPERIORITY|||||||0.041|||||||ANOVA|||||||0.041
91490666|NCT03298867|182854069|SUPERIORITY||Stratified difference in percentages|36.03|STANDARD_ERROR_OF_MEAN|9.51|<|0.001|TWO_SIDED|95.0|17.39|54.67||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||54.67|17.39|<0.001
91490667|NCT03298867|182854070|SUPERIORITY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|95.0|-2.77|-1.8||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||-1.80|-2.77|<0.001
91490668|NCT03298867|182854071|SUPERIORITY||Stratified difference in percentages|39.29|STANDARD_ERROR_OF_MEAN|12.11||0.001|TWO_SIDED|95.0|15.55|63.02||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||63.02|15.55|0.001
91528273|NCT00180713|182931801|SUPERIORITY|||||||0.26|||||||ANOVA|||||||0.26
91528274|NCT05295732|182931802|SUPERIORITY||treatment difference|-1.0||||0.39|TWO_SIDED|95.0|-18.4|16.5|||Cochran-Mantel-Haenszel|||||16.5|-18.4|0.39
91528275|NCT02322814|182931833|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.247||95.0|0.43|1.24|||Log Rank|||||1.24|0.43|0.2470
91528276|NCT02322814|182931835|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5912||95.0|0.65|2.13|||Log Rank|||||2.13|0.65|0.5912
91727814|NCT00286455|183351259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|||<|0.001|TWO_SIDED|95.0|-0.099|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.099|<0.001
91727815|NCT00286455|183351259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052||||0.001|TWO_SIDED|95.0|-0.083|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.083|0.001
91727816|NCT00286455|183351260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|||<|0.001|TWO_SIDED|95.0|-0.103|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.103|<0.001
91727817|NCT00286455|183351260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||<|0.001|TWO_SIDED|95.0|-0.109|-0.037||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.037|-0.109|<0.001
91727818|NCT00286455|183351261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||0.021|TWO_SIDED|95.0|-0.084|-0.007||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.007|-0.084|0.021
91727819|NCT00286455|183351261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.043|TWO_SIDED|95.0|-0.079|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.079|0.043
91727820|NCT00286455|183351262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|||<|0.001|TWO_SIDED|95.0|-0.255|-0.069||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.069|-0.255|<0.001
91727821|NCT00286455|183351262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.001|TWO_SIDED|95.0|-0.254|-0.065||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.065|-0.254|0.001
91490669|NCT03298867|182854072|SUPERIORITY||Difference in LS mean|9.36|STANDARD_ERROR_OF_MEAN|2.651|<|0.001|TWO_SIDED|95.0|4.08|14.64||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||14.64|4.08|<0.001
91727822|NCT00286455|183351263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086||||0.001|TWO_SIDED|95.0|-0.138|-0.034||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.034|-0.138|0.001
91727823|NCT00286455|183351263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084||||0.002|TWO_SIDED|95.0|-0.137|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.137|0.002
91727824|NCT00286455|183351264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.23|TWO_SIDED|95.0|-0.568|0.137||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.137|-0.568|0.230
91727825|NCT00286455|183351264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.154||||0.393|TWO_SIDED|95.0|-0.508|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.200|-0.508|0.393
91727826|NCT00286455|183351265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084||||0.703|TWO_SIDED|95.0|-0.348|0.515||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.515|-0.348|0.703
91727827|NCT00286455|183351265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.203|TWO_SIDED|95.0|-0.153|0.717||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.717|-0.153|0.203
91727828|NCT00286455|183351266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169||||0.408|TWO_SIDED|95.0|-0.232|0.569||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.569|-0.232|0.408
91727829|NCT00286455|183351266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.949|TWO_SIDED|95.0|-0.391|0.417||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.417|-0.391|0.949
91727830|NCT00286455|183351267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.886|TWO_SIDED|95.0|-0.44|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.440|0.886
91727831|NCT00286455|183351267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.645|TWO_SIDED|95.0|-0.51|0.317||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.317|-0.510|0.645
91727832|NCT00286455|183351268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.656|TWO_SIDED|95.0|-0.378|0.239||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.239|-0.378|0.656
91727833|NCT00286455|183351268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.819|TWO_SIDED|95.0|-0.347|0.275||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.275|-0.347|0.819
91758753|NCT02611817|183410773|SUPERIORITY||Clopper-Pearson method|4.3||||0.591|TWO_SIDED|95.0|-11.6|20.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||20.3|-11.6|0.591
91758754|NCT00265317|183410774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.3206|TWO_SIDED|80.0|0.575|1.404||Primary analysis was based on an unstratified 1-sided log rank test with alpha=0.1|Log Rank|||Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.||1.404|0.575|0.3206
91758755|NCT00265317|183410775|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.546||||0.6251|TWO_SIDED|95.0|0.267|8.954|||Cochran-Mantel-Haenszel|||95% confidence interval (CI) calculated based on f-distribution||8.954|0.267|0.6251
91758756|NCT00265317|183410776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.3732|TWO_SIDED|95.0|0.572|1.485||1-sided unstratified log-rank test|Log Rank|||||1.485|0.572|0.3732
91758757|NCT00265317|183410778|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.066||||0.6171|TWO_SIDED|95.0|0.705|1.612||p-value from 1-sided unstratified log-rank test|Log Rank|||||1.612|0.705|0.6171
91727834|NCT00286455|183351269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079||||0.642|TWO_SIDED|95.0|-0.411|0.253||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.253|-0.411|0.642
91727835|NCT00286455|183351269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.986|TWO_SIDED|95.0|-0.332|0.338||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.338|-0.332|0.986
91727836|NCT00286455|183351270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686||||0.305|TWO_SIDED|95.0|0.622|4.571|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.571|0.622|0.305
91727837|NCT00286455|183351270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.349||||0.091|TWO_SIDED|95.0|0.873|6.321|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.321|0.873|0.091
91727838|NCT00286455|183351271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.704||||0.001|TWO_SIDED|95.0|1.694|8.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.100|1.694|0.001
91727839|NCT00286455|183351271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.305||||0.003|TWO_SIDED|95.0|1.505|7.255|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.255|1.505|0.003
91727840|NCT00286455|183351272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.905||||0.006|TWO_SIDED|95.0|1.359|6.21|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.210|1.359|0.006
91727841|NCT00286455|183351272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.552|||<|0.001|TWO_SIDED|95.0|2.068|10.017|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.017|2.068|<0.001
91727842|NCT00286455|183351273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.663||||0.004|TWO_SIDED|95.0|1.367|5.188|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.188|1.367|0.004
91727843|NCT00286455|183351273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.277|||<|0.001|TWO_SIDED|95.0|1.671|6.429|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.429|1.671|<0.001
91727844|NCT00286455|183351274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.331||||0.002|TWO_SIDED|95.0|1.714|10.947|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.947|1.714|0.002
91727845|NCT00286455|183351274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.732||||0.001|TWO_SIDED|95.0|1.862|12.025|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||12.025|1.862|0.001
91490670|NCT05263895|182854088|OTHER||Ratio of Adjusted Geometric means|90.54|||||TWO_SIDED|90.0|79.85|102.65||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||102.65|79.85|
91727846|NCT00286455|183351275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.766||||0.153|TWO_SIDED|95.0|0.685|11.16|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.160|0.685|0.153
91727847|NCT00286455|183351275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.632||||0.029|TWO_SIDED|95.0|1.169|18.354|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||18.354|1.169|0.029
91727848|NCT00286455|183351276|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.102
91727849|NCT00286455|183351276|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.063
91727850|NCT00286455|183351277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.18|0.186
91727851|NCT00286455|183351277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.237|TWO_SIDED|95.0|-0.22|0.89||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.89|-0.22|0.237
91727852|NCT00286455|183351278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.702|TWO_SIDED|95.0|-0.74|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.50|-0.74|0.702
91727853|NCT00286455|183351278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.338|TWO_SIDED|95.0|-0.32|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.32|0.338
91727854|NCT00286455|183351279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.978|TWO_SIDED|95.0|-0.74|0.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.72|-0.74|0.978
91727855|NCT00286455|183351279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.73|0.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.74|-0.73|0.991
91727856|NCT00286455|183351280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.539|TWO_SIDED|95.0|-1.16|0.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.61|-1.16|0.539
91727857|NCT00286455|183351280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.379|TWO_SIDED|95.0|-1.29|0.49||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.49|-1.29|0.379
91727858|NCT00286455|183351281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.616|TWO_SIDED|95.0|-4.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-4.4|0.616
91727859|NCT00286455|183351281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.4|0.930
91727860|NCT00286455|183351282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.915|TWO_SIDED|95.0|-5.3|6.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.0|-5.3|0.915
91727861|NCT00286455|183351282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.745|TWO_SIDED|95.0|-4.8|6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-4.8|0.745
91727862|NCT00286455|183351283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.466|TWO_SIDED|95.0|-3.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-3.4|0.466
91727863|NCT00286455|183351283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.154|TWO_SIDED|95.0|-1.5|9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.6|-1.5|0.154
91727864|NCT00286455|183351284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.774|TWO_SIDED|95.0|-5.1|6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.9|-5.1|0.774
91727865|NCT00286455|183351284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.761|TWO_SIDED|95.0|-5.2|7.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.1|-5.2|0.761
91727866|NCT00286455|183351285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.559|TWO_SIDED|95.0|-4.2|7.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.7|-4.2|0.559
91727867|NCT00286455|183351285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.523|TWO_SIDED|95.0|-4.1|8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.0|-4.1|0.523
91727868|NCT00286455|183351286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.739|TWO_SIDED|95.0|-7.4|5.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.2|-7.4|0.739
91727869|NCT00286455|183351286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.388|TWO_SIDED|95.0|-9.3|3.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.6|-9.3|0.388
91727870|NCT04826731|183351287|OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.374
91727871|NCT04826731|183351288|OTHER|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.635
91727872|NCT02933151|183351302|SUPERIORITY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.92|1.14|||||Reference group is usual care|||1.14|0.92|
91727873|NCT02596893|183351304|SUPERIORITY||Stratified Difference|-2.9||||0.2523|TWO_SIDED|95.0|-9.7|3.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||3.9|-9.7|0.2523
91727874|NCT02596893|183351304|SUPERIORITY||Slope|4.8||||0.1626|TWO_SIDED|95.0|-3.0|11.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||11.8|-3.0|0.1626
91727875|NCT02596893|183351304|SUPERIORITY||Stratified Difference|-2.1||||0.442|TWO_SIDED|95.0|-9.1|5.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.3|-9.1|0.4420
91727876|NCT02596893|183351305|SUPERIORITY||Stratified Difference|-2.6||||0.1799|TWO_SIDED|95.0|-9.5|5.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.0|-9.5|0.1799
91727877|NCT02596893|183351305|SUPERIORITY||Stratified Difference|-2.4||||0.2309|TWO_SIDED|95.0|-9.4|4.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.9|-9.4|0.2309
91490671|NCT05263895|182854088|OTHER||Ratio of Adjusted Geometric Means|102.78|||||TWO_SIDED|90.0|90.65|116.53||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.53|90.65|
91727878|NCT02596893|183351305|SUPERIORITY||Stratified Difference|-2.1||||0.3264|TWO_SIDED|95.0|-9.1|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.6|-9.1|0.3264
91727879|NCT02596893|183351306|SUPERIORITY||Stratified Difference|-11.7||||0.0299|TWO_SIDED|95.0|-22.0|-1.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.1|-22.0|0.0299
91727880|NCT02596893|183351306|SUPERIORITY||Stratified difference|-9.9||||0.0582|TWO_SIDED|95.0|-20.3|0.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||0.7|-20.3|0.0582
91727881|NCT02596893|183351306|SUPERIORITY||Stratified difference|-9.7||||0.0741|TWO_SIDED|95.0|-20.1|1.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||1.0|-20.1|0.0741
91727882|NCT02596893|183351307|SUPERIORITY||Stratified difference|-5.8||||0.2493|TWO_SIDED|95.0|-15.5|4.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.0|-15.5|0.2493
91727883|NCT02596893|183351307|SUPERIORITY||Stratified difference|-1.8||||0.716|TWO_SIDED|95.0|-11.8|8.2|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||8.2|-11.8|0.7160
91727884|NCT02596893|183351307|SUPERIORITY||Stratified difference|-5.8||||0.2452|TWO_SIDED|95.0|-15.5|4.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.1|-15.5|0.2452
91727885|NCT02596893|183351308|SUPERIORITY||Stratified difference|-1.3||||0.7541|TWO_SIDED|95.0|-9.8|7.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||7.1|-9.8|0.7541
91727886|NCT02596893|183351308|SUPERIORITY||Stratified difference|-3.7||||0.3784|TWO_SIDED|95.0|-12.0|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.6|-12.0|0.3784
91727887|NCT02596893|183351308|SUPERIORITY||Stratified difference|-4.4||||0.2865|TWO_SIDED|95.0|-12.6|3.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||3.8|-12.6|0.2865
91727888|NCT02596893|183351309|SUPERIORITY||Unstratified CMH|-2.2||||0.3572|TWO_SIDED|95.0|-11.3|7.0|||Cochran-Mantel-Haenszel|p-values were based on the unstratified CMH test when 1 and only 1 of the 2 treatment groups being compared had no subjects in a stratum.|The weighted average of the treatment differences across the strata with the CMH weights.|2-sided 95% CI were based on the unstratified Newcombe method.||7.0|-11.3|0.3572
91727889|NCT02596893|183351309|SUPERIORITY||Stratified difference|4.7||||0.2823|TWO_SIDED|95.0|-8.8|18.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||18.9|-8.8|0.2823
91727890|NCT02596893|183351309|SUPERIORITY||Stratified difference|0.0|||>|0.9999|TWO_SIDED|95.0|-12.8|13.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||13.7|-12.8|> 0.9999
91727891|NCT02596893|183351310|SUPERIORITY||Stratified difference|-0.5||||0.8031|TWO_SIDED|95.0|-6.7|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.9|-6.7|0.8031
91727892|NCT02596893|183351310|SUPERIORITY||Stratified difference|1.4||||0.5583|TWO_SIDED|95.0|-5.1|7.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||7.3|-5.1|0.5583
91727893|NCT02596893|183351310|SUPERIORITY||Stratified difference|-1.0||||0.6123|TWO_SIDED|95.0|-7.2|6.8|||Cochran-Mantel-Haenszel||||The weighted average of the treatment differences across the strata with the CMH weights.|6.8|-7.2|0.6123
91727894|NCT02596893|183351311|SUPERIORITY||Stratified difference|-10.6||||0.0239|TWO_SIDED|95.0|-19.6|-1.4|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.4|-19.6|0.0239
91727895|NCT02596893|183351311|SUPERIORITY||Stratified difference|-1.0||||0.8334|TWO_SIDED|95.0|-10.8|8.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||8.7|-10.8|0.8334
91727896|NCT02596893|183351311|SUPERIORITY||Stratified difference|-3.9||||0.4383|TWO_SIDED|95.0|-13.5|5.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||5.8|-13.5|0.4383
91727897|NCT02596893|183351312|SUPERIORITY||Stratified difference|-1.6||||0.3573|TWO_SIDED|95.0|-8.3|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with CMH weights.|||5.9|-8.3|0.3573
91727898|NCT02596893|183351312|SUPERIORITY||Stratified difference|-2.0||||0.2221|TWO_SIDED|95.0|-8.7|5.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.1|-8.7|0.2221
91727899|NCT02596893|183351312|SUPERIORITY||Stratified difference|-2.0||||0.2578|TWO_SIDED|95.0|-8.7|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-8.7|0.2578
91727900|NCT02596893|183351315|SUPERIORITY||Stratified Difference|0.5||||0.9141|TWO_SIDED|95.0|-8.9|10.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights|||10.0|-8.9|0.9141
91727901|NCT02596893|183351315|SUPERIORITY||Stratified Difference|-3.6||||0.4286|TWO_SIDED|95.0|-12.8|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-12.8|0.4286
91727902|NCT02596893|183351315|SUPERIORITY||Stratified Difference|-2.7||||0.5591|TWO_SIDED|95.0|-12.0|6.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||6.6|-12.0|0.5591
91727903|NCT03280615|183351316|SUPERIORITY|||||||0.257|||||||Fisher Exact|||A Fisher exact test was performed||||0.257
91727904|NCT03280615|183351317|SUPERIORITY|||||||0.231|||||||Fisher Exact|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.231
91727905|NCT03280615|183351318|SUPERIORITY|||||||0.043|||||||Mixed Models Analysis|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.043
91727906|NCT03052257|183351319|SUPERIORITY||Median Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.15|0.3|||Regression, Linear|||||0.30|0.15|<0.0001
91727907|NCT00090402|183351331|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Regression, Linear|Adjusted for age and body mass index||||||0.83
91727908|NCT02327143|183351388|SUPERIORITY_OR_OTHER||Ratio of geometric least squares|0.448|||||TWO_SIDED|90.0|0.395|0.508|||||Absolute bioavailability of LY2835219 following the administration of 200 mg LY2835219 (oral) with 0.4 mg \[13C8\]-LY2835219 (IV).|||0.508|0.395|
91727909|NCT02123511|183351391|SUPERIORITY|||||||0.1232|||||||t-test, 1 sided|||||||0.1232
91727910|NCT02123511|183351392|SUPERIORITY|||||||0.0422|||||||t-test, 1 sided|||||||0.0422
91727911|NCT02123511|183351393|SUPERIORITY|||||||0.5634|||||||t-test, 1 sided|||||||0.5634
91727912|NCT02123511|183351394|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
91490672|NCT05263895|182854088|OTHER||Ratio of Adjusted Geometric Means|138.15|||||TWO_SIDED|90.0|118.03|161.69||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||161.69|118.03|
91696558|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.56||0.34|TWO_SIDED|95.0|-1.63|0.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.57|-1.63|0.34
91696559|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.76|TWO_SIDED|95.0|-1.26|0.92||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.92|-1.26|0.76
91696560|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.15|TWO_SIDED|95.0|-0.42|2.63||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.63|-0.42|0.15
91696561|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.66|-1.66|1.00
91696562|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.78||0.01|TWO_SIDED|95.0|0.38|3.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.43|0.38|0.01
91705410|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|2.11|<|0.001|TWO_SIDED|95.0|5.3|13.65||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||13.65|5.30|<0.001
91705411|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|4.99||0.005|TWO_SIDED|95.0|-24.28|-4.53|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||-4.53|-24.28|0.005
91727913|NCT02123511|183351395|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|||||||0.22
91727914|NCT02123511|183351396|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
91727915|NCT02123511|183351397|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
91727916|NCT02123511|183351398|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
91727917|NCT02123511|183351399|SUPERIORITY|||||||0.48|||||||t-test, 1 sided|||||||0.48
91727918|NCT02123511|183351400|SUPERIORITY|||||||0.3824|||||||Wilcoxon (Mann-Whitney)|||||||0.3824
91758758|NCT00265317|183410779|SUPERIORITY_OR_OTHER||Percentage|32.0|||||TWO_SIDED|95.0|19.7|44.3||||||Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method||44.3|19.7|
91758759|NCT00265317|183410779|SUPERIORITY_OR_OTHER||Percentage|42.0|||||TWO_SIDED|95.0|30.1|54.2||||||Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method||54.2|30.1|
91758760|NCT00265317|183410807|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.748||||0.2247|TWO_SIDED|95.0|0.351|1.591|||Log Rank|||Positive EGFR Expression||1.591|0.351|0.2247
91758761|NCT00265317|183410807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.184||||0.6797|TWO_SIDED|95.0|0.581|2.414|||Log Rank|||Negative EGFR Expression||2.414|0.581|0.6797
91696563|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.11||0.58|TWO_SIDED|95.0|-1.56|2.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.80|-1.56|0.58
91696564|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.23||0.39|TWO_SIDED|95.0|-3.47|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.47|0.39
91696565|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.12||0.45|TWO_SIDED|95.0|-3.05|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.05|0.45
91705412|NCT04767529|183305292|SUPERIORITY|Week 24|Median Difference (Net)|-13.6|STANDARD_ERROR_OF_MEAN|4.98||0.007|TWO_SIDED|95.0|-23.5|-3.76|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||-3.76|-23.50|0.007
91705413|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.04||0.99|TWO_SIDED|95.0|-13.86|14.04||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||14.04|-13.86|0.990
91727919|NCT01423084|183351401|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain||1.23|0.82|
91727920|NCT01423084|183351401|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain||1.1|0.77|
91727921|NCT01423084|183351401|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.81|||||TWO_SIDED|95.0|0.6|1.09||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain||1.09|0.6|
91727922|NCT01423084|183351409|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.83|||||TWO_SIDED|95.0|0.67|1.02||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs||1.02|0.67|
91727923|NCT01133977|183351417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.23|0.75||||||The current study was not powered or designed to determine superiority of the '20 mg Lenvatinib + Dacarbazine (Phase 2)' arm compared with 'Dacarbazine (Phase 2) ' arm.||0.75|0.23|
91727924|NCT02462057|183351421|EQUIVALENCE|The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91727925|NCT01791205|183351447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.538||||0.1194|TWO_SIDED|95.0|0.65|19.33||The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.|Regression, Cox|||The relation between retention rate and DAS28 (\<2.6 vs \<3.2) was assayed with the Cox regression.||19.33|0.65|0.1194
91727926|NCT01791205|183351448|SUPERIORITY_OR_OTHER|||||||0.3895|||||||Regression, Cox|||||||0.3895
91727927|NCT01791205|183351449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.211||||0.49|TWO_SIDED|95.0|0.703|2.086|||Regression, Logistic|||||2.086|0.703|0.4900
91727928|NCT01791205|183351450|SUPERIORITY_OR_OTHER||Delta|-0.042||||0.6908|TWO_SIDED|95.0|-0.251|0.167|||t-test, 2 sided|||||0.167|-0.251|0.6908
91727929|NCT01791205|183351451|SUPERIORITY_OR_OTHER|||||||0.021|||||||Pearson's chi-squared test|||||||0.0210
91727930|NCT03615534|183351484|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.||||0.0001
91727931|NCT03615534|183351485|SUPERIORITY|||||||0.06||||||Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.||||0.060
91727932|NCT03615534|183351485|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.||||0.0001
91727933|NCT03615534|183351485|SUPERIORITY|||||||0.334||||||Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .||||0.334
91727934|NCT03615534|183351485|SUPERIORITY|||||||0.012||||||Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.||||0.012
91727935|NCT03615534|183351485|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.||||0.001
91727936|NCT03615534|183351486|SUPERIORITY|||||||0.058||||||Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.||||0.058
91727937|NCT03615534|183351486|SUPERIORITY|||||||0.067||||||Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .||||0.067
91758762|NCT00265317|183410807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
91758763|NCT00265317|183410809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3223|TWO_SIDED|95.0|0.458|1.628|||Log Rank|||Positive EGFR Expression||1.628|0.458|0.3223
91758764|NCT00265317|183410809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.4608|TWO_SIDED|95.0|0.362|2.474|||Log Rank|||Negative EGFR Expression||2.474|0.362|0.4608
91758765|NCT00265317|183410809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
91758766|NCT00265317|183410811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.5526|TWO_SIDED|95.0|0.542|2.031|||Log Rank|||No EGFR Gene Copy Number Increase||2.031|0.542|0.5526
91758767|NCT00265317|183410811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Copy Number Increase||1.344|0.380|0.1529
91758768|NCT00265317|183410813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.5839|TWO_SIDED|95.0|0.557|2.085|||Log Rank|||No EGFR Gene Amplification||2.085|0.557|0.5839
91758769|NCT00265317|183410813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Amplification||1.344|0.380|0.1529
91490673|NCT05263895|182854088|OTHER||Ratio of Adjusted Geometric Means|30.8|||||TWO_SIDED|90.0|25.7|35.2||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||35.20|25.70|
91490674|NCT05263895|182854089|OTHER||Ratio of Adjusted Geometric Means|91.26|||||TWO_SIDED|90.0|80.46|103.51||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||103.51|80.46|
91696566|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.34||0.1147|TWO_SIDED|95.0|-0.13|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.13|0.1147
91696567|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.49||0.3721|TWO_SIDED|95.0|-1.41|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.53|-1.41|0.3721
91696568|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.49||0.8827|TWO_SIDED|95.0|-0.89|1.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.03|-0.89|0.8827
91696569|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.68||0.4335|TWO_SIDED|95.0|-0.8|1.87||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.87|-0.80|0.4335
91696570|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.74||0.4063|TWO_SIDED|95.0|-2.07|0.84||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.84|-2.07|0.4063
91696571|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.68||0.0132|TWO_SIDED|95.0|0.35|3.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.03|0.35|0.0132
91758770|NCT00265317|183410815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6324|TWO_SIDED|95.0|0.516|2.608|||Log Rank|||Wild Type EGFR Gene Mutation||2.608|0.516|0.6324
91758771|NCT00265317|183410815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2413|TWO_SIDED|95.0|0.464|1.424|||Log Rank|||Indeterminate EGFR Gene Mutation||1.424|0.464|0.2413
91758772|NCT00265317|183410817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481||||0.2077|TWO_SIDED|95.0|0.079|2.91|||Log Rank|||Mutated KRAS Gene Mutation||2.910|0.079|0.2077
91490675|NCT05263895|182854089|OTHER||Ratio of Adjusted Geometric Means|102.49|||||TWO_SIDED|90.0|90.36|116.26||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.26|90.36|
91696572|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|0.98||0.3949|TWO_SIDED|95.0|-1.08|2.75||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.75|-1.08|0.3949
91696573|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|1.08||0.7145|TWO_SIDED|95.0|-2.5|1.72||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.72|-2.50|0.7145
91696574|NCT04075682|183287138|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.98||0.6081|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6081
91696575|NCT04075682|183287139|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.46||0.58|TWO_SIDED|95.0|-1.15|0.64||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.64|-1.15|0.58
91696576|NCT04075682|183287139|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.9||0.82|TWO_SIDED|95.0|-1.98|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.57|-1.98|0.82
91705414|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|7.01||0.98|TWO_SIDED|95.0|-14.07|13.71||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||13.71|-14.07|0.980
91705415|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|5.52|<|0.001|TWO_SIDED|95.0|-33.58|-11.71|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||-11.71|-33.58|<0.001
91705416|NCT04767529|183305292|SUPERIORITY|Week 24|Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|5.51|<|0.001|TWO_SIDED|95.0|-33.56|-11.74|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50mg - placebo) in non-HDL cholesterol (mg/dL)||-11.74|-33.56|<0.001
91705417|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|7.9||0.443|TWO_SIDED|95.0|-21.72|9.56||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||9.56|-21.72|0.443
91705418|NCT04767529|183305292|SUPERIORITY|Week 96|Mean Difference (Net)|-8.2|STANDARD_ERROR_OF_MEAN|7.86||0.299|TWO_SIDED|95.0|-23.77|7.36||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in non-HDL cholesterol (mg/dL)||7.36|-23.77|0.299
91696577|NCT04075682|183287139|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.31||0.2|TWO_SIDED|95.0|-0.9|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.24|-0.90|0.20
91696578|NCT04075682|183287139|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.36||0.88|TWO_SIDED|95.0|-0.77|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation analysis are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-0.77|0.8800
91696579|NCT04075682|183287139|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8864|TWO_SIDED|95.0|-1.3|1.5||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.50|-1.30|0.8864
91696580|NCT04075682|183287139|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.02||0.2748|TWO_SIDED|95.0|-0.89|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.12|-0.89|0.2748
91696581|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.5||0.83|TWO_SIDED|95.0|0.45|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||2.70|0.45|0.83
91696582|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.86|STANDARD_ERROR_OF_MEAN|1.34||0.03|TWO_SIDED|95.0|1.14|7.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||7.18|1.14|0.03
91705419|NCT04767529|183305301|SUPERIORITY|Week 24|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.18||0.75|TWO_SIDED|95.0|-1.96|2.72||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in body weight (kg)||2.72|-1.96|0.750
91705420|NCT04767529|183305301|SUPERIORITY|Week 24|Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.18||0.042|TWO_SIDED|95.0|-4.75|-0.09||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||-0.09|-4.75|0.042
91705421|NCT04767529|183305301|SUPERIORITY|Week 96|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|2.07||0.564|TWO_SIDED|95.0|-2.9|5.29|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (28 mg EFX - placebo) in body weight (kg)||5.29|-2.90|0.564
91727938|NCT03615534|183351487|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.||||0.001
91727939|NCT03615534|183351488|SUPERIORITY|||||||0.786||||||Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m\^2.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.||||0.786
91727940|NCT03615534|183351489|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.||||0.0001
91727941|NCT03615534|183351490|OTHER|||||||0.201||||||Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|"Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.~."||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.||||0.201
91727942|NCT03615534|183351490|SUPERIORITY|||||||0.033||||||Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.||||0.033
91727943|NCT03615534|183351490|SUPERIORITY|||||||0.511||||||Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.||||0.511
91727944|NCT03615534|183351491|OTHER|||||||0.434||||||Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.||||0.434
91727945|NCT03615534|183351491|SUPERIORITY|||||||0.966||||||Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.||||0.966
91727946|NCT03757715|183351561|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.16
91727947|NCT03757715|183351562|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
91758773|NCT00265317|183410817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.6439|TWO_SIDED|95.0|0.534|2.531|||Log Rank|||Wild Type KRAS Gene Mutation||2.531|0.534|0.6439
91758774|NCT00265317|183410817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.2664|TWO_SIDED|95.0|0.457|1.489|||Log Rank|||Indeterminate KRAS Gene Mutation||1.489|0.457|0.2664
91758775|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7423|TWO_SIDED|95.0|0.541|2.36||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.360|0.541|0.7423
91758776|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.598||||0.157|TWO_SIDED|95.0|0.29|1.236||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.236|0.290|0.1570
91758777|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.7954|TWO_SIDED|95.0|0.131|4.819||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||4.819|0.131|0.7954
91758778|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.833||||0.621|TWO_SIDED|95.0|0.401|1.732||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/G||1.732|0.401|0.6210
91758779|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.5268|TWO_SIDED|95.0|0.385|1.64||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/T||1.640|0.385|0.5268
91758780|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.9753|TWO_SIDED|95.0|0.504|2.027||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/T||2.027|0.504|0.9753
91758781|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.378||||0.0141|TWO_SIDED|95.0|0.168|0.85||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||0.850|0.168|0.0141
91758782|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
91758783|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.2788|TWO_SIDED|95.0|0.422|1.288||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.288|0.422|0.2788
91758784|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8971|TWO_SIDED|95.0|0.352|3.286||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||3.286|0.352|0.8971
91758785|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.6559|TWO_SIDED|95.0|0.251|2.388||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||2.388|0.251|0.6559
91528277|NCT01744860|182931857|SUPERIORITY_OR_OTHER||Kappa coefficient|0.8611|||||TWO_SIDED|95.0|0.8125|0.9097||||||"Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory in-house methods and Cobas 4800 Mutation Test."||0.9097|0.8125|
91696583|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.27||0.18|TWO_SIDED|95.0|0.15|1.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||1.44|0.15|0.18
91696584|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.3||0.99|TWO_SIDED|95.0|0.08|12.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||12.57|0.08|0.99
91696585|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.52||0.86|TWO_SIDED|95.0|0.29|2.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.||These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.82|0.29|0.86
91696586|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.43||0.8045|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||||0.8045
91696587|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.53|STANDARD_ERROR_OF_MEAN|1.01||0.0205|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||||0.0205
91696588|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.26||0.1918|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||||0.1918
91705422|NCT04767529|183305301|SUPERIORITY|Week 96|Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.06||0.348|TWO_SIDED|95.0|-6.02|2.14|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||2.14|-6.02|0.348
91705423|NCT04767529|183305302|SUPERIORITY|Week 24|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.102|TWO_SIDED|95.0|-4.5|0.4|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||0.4|-4.5|0.102
91528278|NCT05200936|182931900|SUPERIORITY|||||||0.7145||||||p-value is 1-sided|Mixed Models Analysis|||||||0.7145
91528279|NCT05200936|182931901|SUPERIORITY|||||||0.9613|||||||ANCOVA|||||||0.9613
91727948|NCT01122680|183351609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.036|0.19||First step of closed testing procedure, where the active treatments are compared to placebo. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Placebo||0.190|0.036|0.0043
91727949|NCT01122680|183351609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.039||0.1484||95.0|-0.021|0.135||Second step of closed testing procedure. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Placebo||0.135|-0.021|0.1484
91727950|NCT01122680|183351609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.036||0.0664||95.0|-0.005|0.138||This test is considered as descriptive.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.138|-0.005|0.0664
91727951|NCT01122680|183351609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.039||||95.0|-0.031|0.124|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R1.25||0.124|-0.031|
91727952|NCT01122680|183351609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.036||||95.0|-0.014|0.126|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R2.5||0.126|-0.014|
91727953|NCT01122680|183351609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.088|0.069|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Tio R1.25||0.069|-0.088|
91727954|NCT05529173|183351635|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91727955|NCT02777190|183351705|NON_INFERIORITY|Margin of 4 hours|Mean Difference (Final Values)|-1.7||||0.09|ONE_SIDED|97.5||6.7|||t-test, 1 sided|one-sided two-sample t-test with alpha=0.025|Difference calculated as oral minus vaginal|||6.7||0.09
91696589|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|1.12||0.99|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||||0.99
91705424|NCT04767529|183305302|SUPERIORITY|Week 24|Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|1.26||0.009|TWO_SIDED|95.0|-5.8|-0.8|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.8|-5.8|0.009
91727956|NCT02777190|183351706|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
91727957|NCT02777190|183351707|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
91727958|NCT02777190|183351708|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91727959|NCT02777190|183351709|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
91727960|NCT02777190|183351710|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91727961|NCT02777190|183351711|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
91727962|NCT02777190|183351713|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
91727963|NCT02777190|183351714|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91727964|NCT02777190|183351715|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
91727965|NCT02777190|183351716|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91727966|NCT02777190|183351717|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91727967|NCT01452789|183351718|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
91727968|NCT01452789|183351719|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
91727969|NCT01452789|183351720|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
91727970|NCT00066170|183351722|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
91727971|NCT00066170|183351722|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
91727972|NCT00754559|183351739|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Exact Binomial Test|||Null hypothesis: Proportion of participants reaching LDAS (≤ 3.2) at Week 24 equals (=) expected proportion of 42%.||||<0.001
91727973|NCT04000724|183351793|SUPERIORITY||Average treatment effect|-0.54||||0.141|TWO_SIDED|95.0|-1.26|0.18|||Longitudinal Targeted Maximum Likelihood|||||0.18|-1.26|0.141
91727974|NCT04000724|183351793|SUPERIORITY||Average treatment effect|-0.51||||0.123|TWO_SIDED|95.0|-1.16|0.14|||Longitudinal Targeted Maximum Likelihood|||||0.14|-1.16|0.123
91727975|NCT04000724|183351794|SUPERIORITY||Average treatment effect|-0.24||||0.127|TWO_SIDED|95.0|-0.56|0.07|||Longitudinal Targeted Maximum Likelihood|||||.07|-.56|.127
91727976|NCT04000724|183351794|SUPERIORITY||Average treatment effect|-0.02||||0.899|TWO_SIDED|95.0|-0.34|0.3|||Longitudinal Targeted Maximum Likelihood|||||.30|-.34|.899
91727977|NCT00472641|183351804|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
91727978|NCT00472641|183351805|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
91727979|NCT00309244|183351811|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 25% drop-out rate, 677 subjects were randomized.|Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|
91758786|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939||||0.8563|TWO_SIDED|95.0|0.466|1.889||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||1.889|0.466|0.8563
91490676|NCT05263895|182854089|OTHER||Ratio of Adjusted Geometric Means|136.99|||||TWO_SIDED|90.0|117.09|160.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||160.27|117.09|
91490677|NCT05263895|182854089|OTHER||Ratio of Adjusted Geometric Means|29.77|||||TWO_SIDED|90.0|25.45|34.83||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||34.83|25.45|
91696590|NCT04075682|183287140|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|1.54||0.6873|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||||0.6873
91696591|NCT04075682|183287141|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.39||0.37|TWO_SIDED|95.0|-1.12|0.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.41|-1.12|0.37
91696592|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.05||0.92|TWO_SIDED|95.0|0.9|1.1||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.10|0.90|0.92
91696593|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED|95.0|0.9|1.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.11|0.90|0.95
91696594|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.08||0.85|TWO_SIDED|95.0|0.85|1.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||1.14|0.85|0.85
91705425|NCT04767529|183305302|SUPERIORITY|Week 96|Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.43||0.021|TWO_SIDED|95.0|-6.2|-0.5||Threshold for significance set at P\<0.05|Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 28 mg and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.5|-6.2|0.021
91758787|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.382||||0.668|TWO_SIDED|95.0|0.13|1.12||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||1.120|0.130|0.668
91758788|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs35636987 Genotype: C/C||1.309|0.488|0.3681
91758789|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.752|TWO_SIDED|95.0|0.331|2.237||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||2.237|0.331|0.7520
91758790|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.0833|TWO_SIDED|95.0|0.276|1.098||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.098|0.276|0.0833
91758791|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.4772|TWO_SIDED|95.0|0.444|5.506||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||5.506|0.444|0.4772
91758792|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.034||||0.9235|TWO_SIDED|95.0|0.522|2.048||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.048|0.522|0.9235
91696595|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.07||0.75|TWO_SIDED|95.0|0.84|1.13||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.13|0.84|0.75
91490678|NCT05263895|182854090|OTHER||Ratio of Adjusted Geometric Means|94.28|||||TWO_SIDED|90.0|80.77|110.05||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||110.05|80.77|
91490679|NCT05263895|182854090|OTHER||Ratio of Adjusted Geometric Means|108.6|||||TWO_SIDED|90.0|93.04|126.76||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||126.76|93.04|
91696596|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.97|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|0.78|1.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.20|0.78|0.78
91696597|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|0.94|1.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.82|0.94|0.11
91696598|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.93|TWO_SIDED|95.0|0.8|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.22|0.80|0.93
91705426|NCT04767529|183305302|SUPERIORITY|Week 96|Mean Difference (Net)|-6.6|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-9.4|-3.7|||Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 50 mg and placebo group|Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-3.7|-9.4|<0.001
91705427|NCT02636699|183305316|OTHER||Difference in Response Rates (%)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|29.8|||Wald|||Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates ≥15%.||29.8|12.4|<0.001
91490680|NCT05263895|182854090|OTHER||Ratio of Adjusted Geometric Means|264.12|||||TWO_SIDED|90.0|232.32|300.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||300.27|232.32|
91490681|NCT05263895|182854090|OTHER||Ratio of Adjusted Geometric Means|145.53|||||TWO_SIDED|90.0|128.01|165.45||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||165.45|128.01|
91705428|NCT02636699|183305317|OTHER||Difference in Response Rates (%)|19.0||||0.105|TWO_SIDED|95.0|-6.4|38.4|||Wald|||"Screening ED subgroup 1:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||38.4|-6.4|0.105
91705429|NCT02636699|183305317|OTHER||Difference in Response Rates (%)|22.3|||<|0.001|TWO_SIDED|95.0|12.1|30.8|||Wald|||"Screening ED subgroup 2:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||30.8|12.1|<0.001
91490682|NCT01673867|182854100|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0015|TWO_SIDED|95.92|0.59|0.89|||Log Rank||HR = Nivolumab over docetaxel|||0.89|0.59|0.0015
91696599|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.11||0.86|TWO_SIDED|95.0|0.78|1.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.23|0.78|0.86
91696600|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.94|TWO_SIDED|95.0|0.81|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||1.22|0.81|0.94
91696601|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.21||0.13|TWO_SIDED|95.0|0.93|1.78||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.78|0.93|0.13
91696602|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|0.7|1.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.41|0.70|0.96
91696603|NCT04075682|183287142|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.16||0.95|TWO_SIDED|95.0|0.72|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|0.72|0.95
91705430|NCT02636699|183305318|OTHER||Difference in Median CRD|297.0|||<|0.001|TWO_SIDED|95.0|130.0|317.0|||Wilcoxon rank-sum test|||The treatment effect was estimated using the Hodges-Lehmann estimate of the difference in median CRDs at Month 12.||317.0|130.0|<0.001
91705431|NCT03004924|183305375|SUPERIORITY||Difference in response rate|7.7||||0.127|TWO_SIDED|95.0|-1.6|16.9|||Fisher Exact|||||16.9|-1.6|0.127
91705432|NCT03004924|183305376|SUPERIORITY||Difference in response rate|-3.5||||0.5|TWO_SIDED|95.0|-12.8|5.9|||Fisher Exact|||||5.9|-12.8|0.500
91490683|NCT01709513|182854121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.6|-24.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-24.2|-36.6|<0.0001
91705433|NCT02867202|183305390|OTHER||||||<|0.05|||||||t-test, 2 sided|||Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \< 0.05 was considered statistically significant.||||<0.05
91696604|NCT00955955|183287147|SUPERIORITY_OR_OTHER||Mean Score Reduction|-5.6|STANDARD_DEVIATION|5.7||0.05||95.0|||||SPCD|Sequential Parallel Comparison Design (SPCD)|These results reflect the mean score reduction for the pooled Deplin sample.|Hypothesis 1: There will be a statistically significant difference between the two groups in the degree of improvement, as measured by the change in the 17-item Hamilton Depression Rating Scale (HAM-D-17) score from baseline to endpoint, using the sequential parallel comparison design \[51\]; with a greater degree of reduction in HAM-D-17 scores in the 6(S)-5-MTHF 15 mg qd group than in the placebo group, with the change on placebo being estimated from Trials 1 and 2.||||.05
91696605|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|Geometric Mean Titer (GMT) Ratio|0.69|||||TWO_SIDED|95.0|0.46|1.04|||||Analysis of variance (ANOVA) model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.04|0.46|
91696606|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.6|1.38|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.38|0.60|
91696607|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.41|0.96|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||0.96|0.41|
91696608|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.98|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.71|0.98|
91696609|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.51|0.88|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.88|0.51|
91696610|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.15|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.15|0.65|
91696611|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.27|||||TWO_SIDED|95.0|0.91|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.78|0.91|
91696612|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.68|1.33|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.33|0.68|
91696613|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.87|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.87|
91696614|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.82|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||0.82|0.46|
91696615|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.22|2.17|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.17|1.22|
91696616|NCT03423173|183287154|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.75|1.35|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.35|0.75|
91696617|NCT03423173|183287155|OTHER||Seropositivity Rates Difference|0.6|||||TWO_SIDED|95.0|-4.99|6.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||6.06|-4.99|
91696618|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-1.65|||||TWO_SIDED|95.0|-6.9|3.19|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||3.19|-6.90|
91696619|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-2.25|||||TWO_SIDED|95.0|-7.45|2.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||2.69|-7.45|
91696620|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|7.87|||||TWO_SIDED|95.0|0.64|15.3|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||15.30|0.64|
91696621|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|1.5|||||TWO_SIDED|95.0|-4.67|7.65|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||7.65|-4.67|
91696622|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-6.37|||||TWO_SIDED|95.0|-14.0|1.04|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||1.04|-14.00|
91696623|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|0.72|||||TWO_SIDED|95.0|-3.87|5.29|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||5.29|-3.87|
91696624|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-0.83|||||TWO_SIDED|95.0|-5.24|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||3.17|-5.24|
91696625|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-1.55|||||TWO_SIDED|95.0|-6.05|2.58|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||2.58|-6.05|
91696626|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|2.42|||||TWO_SIDED|95.0|-2.12|7.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||7.44|-2.12|
91696627|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|0.83|||||TWO_SIDED|95.0|-3.41|5.24|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||5.24|-3.41|
91696628|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-1.59|||||TWO_SIDED|95.0|-6.67|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||3.17|-6.67|
91696629|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|2.93|||||TWO_SIDED|95.0|-3.07|9.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||9.06|-3.07|
91696630|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-0.81|||||TWO_SIDED|95.0|-6.17|4.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||4.44|-6.17|
91696631|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-3.73|||||TWO_SIDED|95.0|-9.74|2.03|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||2.03|-9.74|
91696632|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|6.79|||||TWO_SIDED|95.0|-1.03|14.56|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||14.56|-1.03|
91696633|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|3.0|||||TWO_SIDED|95.0|-4.28|10.23|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||10.23|-4.28|
91696634|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-3.79|||||TWO_SIDED|95.0|-11.97|4.39|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||4.39|-11.97|
91696635|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-2.5|||||TWO_SIDED|95.0|-7.68|1.55|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||1.55|-7.68|
91696636|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|0.04|||||TWO_SIDED|95.0|-5.47|5.62|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||5.62|-5.47|
91696637|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|2.54|||||TWO_SIDED|95.0|-1.52|7.81|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||7.81|-1.52|
91696638|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|-1.52|||||TWO_SIDED|95.0|-9.14|5.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||5.69|-9.14|
91696639|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|1.13|||||TWO_SIDED|95.0|-6.9|8.95|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||8.95|-6.90|
91696640|NCT03423173|183287155|OTHER||Seropositivity Rate Difference|2.64|||||TWO_SIDED|95.0|-4.68|10.18|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||10.18|-4.68|
91696641|NCT03423173|183287156|OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.42|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.42|0.56|
91696642|NCT03423173|183287156|OTHER||GMT Ratio|0.81|||||TWO_SIDED|95.0|0.51|1.28|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.28|0.51|
91696643|NCT03423173|183287156|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.46|1.16|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.16|0.46|
91696644|NCT03423173|183287156|OTHER||GMT Ratio|1.37|||||TWO_SIDED|95.0|1.02|1.86|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.86|1.02|
91696645|NCT03423173|183287156|OTHER||GMT Ratio|0.65|||||TWO_SIDED|95.0|0.48|0.87|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.87|0.48|
91696646|NCT03423173|183287156|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.66|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.21|0.66|
91696647|NCT03423173|183287156|OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.0|1.94|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.94|1.00|
91696648|NCT03423173|183287156|OTHER||GMT Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.21|0.64|
91696649|NCT03423173|183287156|OTHER||GMT Ratio|1.23|||||TWO_SIDED|95.0|0.88|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.88|
91528280|NCT00405353|182931917|OTHER||||||<|0.05|||||||Mixed Models Analysis|Linear regressions were used to determine slopes of brain volume changes. Statistical software package SAS was used to perform the analysis.||Percent change in brain volume against time scatter plot with a Loess regression curve was produced and a first-degree spline model was developed. This model fitted line pieces for pre-treatment and early treatment periods (month -6 to month 3) and treatment response period (months 3-12), and these pieces were joined together to achieve continuity. Slopes of these lines were estimated and compared. A random intercept was set in the model to allow the difference among subjects.||||<0.05
91696650|NCT03423173|183287156|OTHER||GMT Ratio|0.83|||||TWO_SIDED|95.0|0.58|1.18|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.18|0.58|
91696651|NCT03423173|183287156|OTHER||GMT Ratio|1.51|||||TWO_SIDED|95.0|1.07|2.14|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.14|1.07|
91696652|NCT03423173|183287156|OTHER||GMT Ratio|1.25|||||TWO_SIDED|95.0|0.88|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.78|0.88|
91696653|NCT01062113|183287178|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|38.2|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|20.3|56.1||The difference in the efficacy rates was tested using normal distribution at a significance level of 2-sided 5%. 2-sided 95% confidence interval (CI) for the difference in the efficacy rates was calculated using normal approximation.|asymptotic z-test|||||56.1|20.3|<0.0001
91696654|NCT01062113|183287180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
91696655|NCT01062113|183287181|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91696656|NCT03655470|183287209|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.07||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||.30
91696657|NCT03063086|183287211|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.0001|TWO_SIDED|95.0|0.137|0.208|||Mixed Models Analysis|||||0.208|0.137|<0.0001
91696658|NCT03063086|183287211|SUPERIORITY||Median Difference (Final Values)|0.159|||<|0.0001|TWO_SIDED|95.0|0.123|0.195|||Mixed Models Analysis|||||0.195|0.123|<0.0001
91696659|NCT03063086|183287216|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.0001|TWO_SIDED|95.0|0.086|0.161|||Mixed Models Analysis|||||0.161|0.086|<0.0001
91696660|NCT05481125|183287253|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.0125|||ONE_SIDED|95.0||-0.024||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Mean difference (Clareon/Clareon Toric minus Eyhance/Eyhance Toric). Upper Confidence Limit is presented.|||-0.024||
91696661|NCT03702010|183287259|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||Baseline VAS||||0.112
91696662|NCT03702010|183287259|SUPERIORITY|||||||0.323|||||||t-test, 2 sided|||After first stimulation VAS||||0.323
91696663|NCT03702010|183287259|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||After second stimulation||||0.760
91696664|NCT03702010|183287259|SUPERIORITY|||||||0.624|||||||t-test, 2 sided|||End of Follow-up||||0.624
91696665|NCT03702010|183287260|SUPERIORITY|||||||0.589|||||||t-test, 2 sided|||After first stimulation||||0.589
91696666|NCT03702010|183287260|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||After second stimulation||||0.704
91696667|NCT03702010|183287260|SUPERIORITY|||||||0.908|||||||t-test, 2 sided|||End of Follow-up||||0.908
91696668|NCT03702010|183287261|SUPERIORITY|||||||0.231|||||||t-test, 2 sided|||Baseline||||0.231
91696669|NCT03702010|183287261|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||After first stimulation||||0.663
91696670|NCT03702010|183287261|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||After second stimulation||||0.998
91696671|NCT03702010|183287261|SUPERIORITY|||||||0.713|||||||t-test, 2 sided|||End of Follow-up||||0.713
91696672|NCT04791319|183287268|SUPERIORITY||MH weights|7.1||||0.489|TWO_SIDED|95.0|-12.1|26.2||Threshold for significance at 0.05 level.|Chi-squared|||||26.2|-12.1|0.489
91696673|NCT04791319|183287268|SUPERIORITY||MH Weights|7.1||||0.448|TWO_SIDED|95.0|-9.4|23.7|||Chi-squared|||||23.7|-9.4|0.448
91696674|NCT04791319|183287268|SUPERIORITY||MH Weights|42.0||||0.001|TWO_SIDED|95.0|22.9|61.1|||Chi-squared|||||61.1|22.9|0.001
91696675|NCT01704651|183287309|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
91696676|NCT01704651|183287310|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91696677|NCT00791661|183287314|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.92||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
91696678|NCT00791661|183287316|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.81||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
91696679|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-8.1||||0.368|TWO_SIDED|90.0|-23.0|6.8||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||6.8|-23.0|0.368
91696680|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-16.6||||0.079|TWO_SIDED|90.0|-32.2|-1.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-1.1|-32.2|0.079
91696681|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-25.7||||0.007|TWO_SIDED|90.0|-40.9|-10.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-10.5|-40.9|0.007
91696682|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Diffrence in least squares mean|-36.3|||<|0.001|TWO_SIDED|90.0|-52.0|-20.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-20.5|-52.0|<.001
91696683|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.7||||0.147|TWO_SIDED|90.0|-42.2|2.7|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.|||2.7|-42.2|0.147
91696684|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|12.3||||0.114|TWO_SIDED|90.0|-0.5|25.2|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.|||25.2|-0.5|0.114
91696685|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-28.9||||0.026|TWO_SIDED|90.0|-49.9|-7.9|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.|||-7.9|-49.9|0.026
91696686|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-57.6|||<|0.001|TWO_SIDED|90.0|-73.3|-41.9||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-41.9|-73.3|<.001
91696687|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-15.3||||0.099|TWO_SIDED|90.0|-30.5|-0.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-0.1|-30.5|0.099
91727980|NCT00309244|183351812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.41||0.0002|TWO_SIDED|95.0|-2.4|-0.7|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-0.7|-2.4|0.0002
91727981|NCT00309244|183351813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_ERROR_OF_MEAN|5.9||0.0029|TWO_SIDED|95.0|-29.3|-6.1|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline fasting plasma glucose as covariate||-6.1|-29.3|0.0029
91727982|NCT00309244|183351814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.2793|TWO_SIDED|95.0|0.486|1.231|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.231|0.486|0.2793
91727983|NCT00309244|183351815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.423|||<|0.001|TWO_SIDED|95.0|0.307|0.581|||Regression, Logistic||Model: Treatment + Site|||0.581|0.307|<0.001
91727984|NCT00309244|183351816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.409||||0.0066|TWO_SIDED|95.0|0.215|0.78|||Regression, Logistic||Model: Treatment + Site|||0.780|0.215|0.0066
91696688|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-43.9|||<|0.001|TWO_SIDED|90.0|-60.8|-27.0||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-27.0|-60.8|<.001
91696689|NCT00791661|183287320|SUPERIORITY_OR_OTHER||Difference in least squares mean|-59.4|||<|0.001|TWO_SIDED|90.0|-75.1|-43.7||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-43.7|-75.1|<.001
91696690|NCT00520533|183287445|SUPERIORITY|||||||0.194|||||||t-test, 2 sided|||Comparison of Biological T1/2 at Week 1 and Week 5.||||0.194
91696691|NCT00520533|183287446|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|||Comparison of Effective T1/2 at Week 1 and Week 5.||||0.172
91727985|NCT00309244|183351817|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Generalized Estimation Equation|Based on Poisson distribution||||||0.0027
91727986|NCT00309244|183351818|SUPERIORITY_OR_OTHER|||||||0.0591|||||||Generalized Estimating Equation|Based on Poission distribution||||||0.0591
91490684|NCT01709513|182854122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.1|||<|0.0001|TWO_SIDED|95.0|-40.7|-29.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-29.5|-40.7|<0.0001
91490685|NCT01709513|182854123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|95.0|-36.9|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-26.1|-36.9|<0.0001
91727987|NCT04223687|183351832|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.01
91490686|NCT01709513|182854124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-38.0|-28.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.2|-38.0|<0.0001
91490687|NCT01709513|182854125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-29.8|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-29.8|<0.0001
91490688|NCT01709513|182854126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-24.4|-32.1|<0.0001
91490689|NCT01709513|182854127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-30.4|-20.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.8|-30.4|<0.0001
91490690|NCT01709513|182854128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-33.9|-25.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.8|-33.9|<0.0001
91490691|NCT01709513|182854129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-24.7|-17.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.0|-24.7|<0.0001
91490692|NCT01709513|182854130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-28.7|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-28.7|<0.0001
91727988|NCT04223687|183351833|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|t-test, 2 sided|||||||<0.01
91727989|NCT04223687|183351834|SUPERIORITY|||||||0.03||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.03
91727990|NCT04223687|183351835|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||0.37
91727991|NCT04223687|183351836|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91727992|NCT04223687|183351837|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91727993|NCT04223687|183351838|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91727994|NCT04223687|183351839|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.001
91727995|NCT04223687|183351840|SUPERIORITY|||||||0.06||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.06
91727996|NCT04223687|183351841|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.37
91727997|NCT04223687|183351842|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
91727998|NCT04223687|183351843|SUPERIORITY|||||||0.42||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.42
91727999|NCT04223687|183351844|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.13
91728000|NCT04223687|183351845|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
91728001|NCT02945046|183351852|OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9093|TWO_SIDED|95.0|-2.72|2.42||Threshold for significance at 0.05 level.|ANCOVA|||||2.42|-2.72|0.9093
91728002|NCT02945046|183351852|OTHER||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.1345|TWO_SIDED|95.0|-4.49|0.61||Threshold for significance at 0.05 level.|ANCOVA|||||0.61|-4.49|0.1345
91490693|NCT01709513|182854131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-29.9|-21.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.5|-29.9|<0.0001
91490694|NCT01709513|182854132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-24.5|-17.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.7|-24.5|<0.0001
91490695|NCT01709513|182854133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.5|||<|0.0001|TWO_SIDED|95.0|6.9|55.2||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||55.2|6.9|<0.0001
91490696|NCT01709513|182854134|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|24.9|||<|0.0001|TWO_SIDED|95.0|8.6|71.9||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.9|8.6|<0.0001
91490697|NCT01709513|182854135|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|11.1|3022.1||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a last observation carried forward (LOCF) approach followed by Exact conditional logistic regression model.||3022.1|11.1|<0.0001
91490698|NCT01709513|182854136|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|109.8|||<|0.0001|TWO_SIDED|95.0|16.5|4759.3||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a LOCF approach followed by Exact conditional logistic regression model.||4759.3|16.5|<0.0001
91490699|NCT01709513|182854137|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-25.5|-11.8||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-11.8|-25.5|<0.0001
91490700|NCT01709513|182854138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.9|||=|0.6997|TWO_SIDED|95.0|-3.8|5.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.6|-3.8|=0.6997
91490701|NCT03166735|182854158|OTHER||Predicted mean daily dose in mg|3.45|STANDARD_ERROR_OF_MEAN|0.1|||||||||non-linear regression||The model fit used power of mean variance estimates (POM) to account for heterogeneity.|D10: Estimated dose reaching \<=10% activity the first time.||||
91490702|NCT03166735|182854160|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0212||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0212
91490703|NCT03166735|182854161|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.127||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1270
91490704|NCT03166735|182854162|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.3324||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.3324
91490705|NCT03166735|182854163|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.129||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1290
91490706|NCT03166735|182854164|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0042||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0042
91490707|NCT03166735|182854165|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0728||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0728
91490708|NCT01543958|182854166|SUPERIORITY_OR_OTHER|||||||0.87||||||not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.87
91490709|NCT01543958|182854167|SUPERIORITY_OR_OTHER|||||||0.62||||||Not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.62
91490710|NCT00926328|182854216|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91490711|NCT00926328|182854217|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91728003|NCT03907579|183351872|SUPERIORITY|||||||0.0001|||||||Wilcoxon Signed Rank Test|z= -3.861||||||0.0001
91696692|NCT03307252|183287462|OTHER||Adjusted geometric mean (gMean) ratio|100.7|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|88.84|114.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|114.15|88.84|
91728004|NCT03319654|183351875|OTHER|A generalized estimating equation (GEE)-model with an exchangeable correlation structure and a logit link function was used to analyze the probability of live birth and clinical pregnancy respectively. All IUI cycles are used in this model with correction for the fact that cycles of the same couple are not independent.|Odds Ratio (OR)|0.94||||0.04|TWO_SIDED|95.0|0.9|0.9985|||GEE-model|||The null hypothesis is: there is no association between % total Sperm DNA Fragmentation and live birth.||0.9985|0.90|0.04
91696693|NCT03307252|183287462|OTHER||Adjusted gMean ratio|93.76|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|86.12|102.06|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|102.06|86.12|
91728005|NCT03319654|183351875|OTHER||Area under the ROC curve|0.576|||>|0.05|TWO_SIDED||||||Receiver Operating Characteristics curve|||||||>0.05
91728006|NCT03259308|183351882|SUPERIORITY|||||||0.027|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.027
91728007|NCT03259308|183351882|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.014
91728008|NCT03259308|183351883|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.001
91728009|NCT03259308|183351883|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.003
91728010|NCT03259308|183351884|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
91490712|NCT01513343|182854230|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|Multinomial logistic regression examined program effects on child BMI categories, controlling for child sex, age (months), \& BMI z-score at pretest.||||||<0.05
91728011|NCT03259308|183351884|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
91728012|NCT03259308|183351885|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
91728013|NCT03259308|183351885|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
91728014|NCT03259308|183351886|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
91728015|NCT03259308|183351886|SUPERIORITY|||||||0.017|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.017
91728016|NCT00066937|183351906|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline to each timepoint||||||<.05
91728017|NCT00066937|183351907|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
91728018|NCT00066937|183351908|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
91728019|NCT00066937|183351909|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
91728020|NCT03389750|183351911|EQUIVALENCE|An F-test was used to assess for significant differences among the 13 dose conditions.||||||0.0001|||||||ANOVA|F = 7.06 (DF=12)||||||.0001
91728021|NCT06868667|183351919|OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.11|1.52|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||1.52|0.11|
91728022|NCT01027754|183351946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Fisher Exact|||||||0.03
91728023|NCT01027754|183351947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Fisher Exact|||||||0.24
91728024|NCT01027754|183351956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91490713|NCT01513343|182854231|SUPERIORITY||||||<|0.05||||||To control for type I errors, the critical P values for each assessment were determined with the unweighted Bonferroni method, dividing the critical value of P \< 0.05 by the number of comparisons conducted for a given assessment.|Mixed Models Analysis|||||||<0.05
91490714|NCT02165215|182854265|SUPERIORITY||Adjusted difference in response rates|7.7||||0.1942|TWO_SIDED|95.0|-4.2|19.2|||Cochran-Mantel-Haenszel|||||19.2|-4.2|0.1942
91696694|NCT03307252|183287462|OTHER||Adjusted gMean Ratio|82.97|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|76.96|89.46|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|89.46|76.96|
91696695|NCT03307252|183287462|OTHER||Adjusted gMean Ratio|113.4|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|97.62|131.72|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|131.72|97.62|
91696696|NCT03307252|183287463|OTHER||Adjusted geometric mean (gMean) ratio|131.41|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|115.93|148.97|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|148.97|115.93|
91696697|NCT03307252|183287463|OTHER||Adjusted gMean ratio|119.78|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|110.03|130.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.39|110.03|
91696698|NCT03307252|183287463|OTHER||Adjusted gMean Ratio|108.55|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|100.68|117.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.03|100.68|
91696699|NCT03307252|183287463|OTHER||Adjusted gMean Ratio|348.06|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|299.64|404.31|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|404.31|299.64|
91696700|NCT03307252|183287464|OTHER||Adjusted geometric mean (gMean) ratio|125.61|STANDARD_ERROR_OF_MEAN|13.2|||TWO_SIDED|90.0|113.99|138.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|138.43|113.99|
91696701|NCT03307252|183287464|OTHER||Adjusted gMean ratio|101.21|STANDARD_ERROR_OF_MEAN|9.2|||TWO_SIDED|90.0|94.59|108.3|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.30|94.59|
91728025|NCT05033561|183351962|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
91758793|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501||||0.0845|TWO_SIDED|95.0|0.223|1.126||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.126|0.223|0.0845
91758794|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.724||||0.5493|TWO_SIDED|95.0|0.284|10.47||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||10.47|0.284|0.5493
91490715|NCT02165215|182854266|SUPERIORITY||Adjusted difference in remission rates|14.6||||0.1524|TWO_SIDED|95.0|-5.55|33.15||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.15|-5.55|0.1524
91490716|NCT02165215|182854267|SUPERIORITY||Adjusted difference in remission rates|8.7||||0.1466|TWO_SIDED|95.0|-3.26|20.21||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||20.21|-3.26|0.1466
91758795|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.521|TWO_SIDED|95.0|0.492|3.987||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.987|0.492|0.5210
91758796|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538||||0.0854|TWO_SIDED|95.0|0.261|1.108||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.108|0.261|0.0854
91728026|NCT05033561|183351962|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
91728027|NCT05033561|183351963|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
91728028|NCT05033561|183351963|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
91728029|NCT01557244|183351976|SUPERIORITY|||||||0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||0.0001
91728030|NCT01557244|183351976|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
91728031|NCT01557244|183351976|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
91728032|NCT01557244|183351976|OTHER||Difference in Least square (LS) Mean|-29.06|||||TWO_SIDED|95.0|-71.42|13.31||||||||13.31|-71.42|
91490717|NCT02165215|182854268|SUPERIORITY||Adjusted difference in remission rates|10.9||||0.3083||95.0|-9.72|30.49||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||30.49|-9.72|0.3083
91490718|NCT02165215|182854269|SUPERIORITY||Adjusted difference in response rates|14.4||||0.0235|TWO_SIDED|95.0|1.84|26.28||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||26.28|1.84|0.0235
91490719|NCT02165215|182854270|SUPERIORITY||Adjusted difference in remission rates|12.8||||0.0293||95.0|1.13|23.89||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.89|1.13|0.0293
91490720|NCT02165215|182854271|SUPERIORITY||Adjusted difference in remission rates|19.8||||0.0075|TWO_SIDED|95.0|5.16|33.11||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.11|5.16|0.0075
91490721|NCT02165215|182854272|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
91490722|NCT02165215|182854273|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
91490723|NCT02165215|182854274|SUPERIORITY||Difference in Least Square Means|-2.8||||0.0266|TWO_SIDED|95.0|-5.3|-0.4||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.4|-5.3|0.0266
91490724|NCT02165215|182854275|SUPERIORITY||Difference in Least Square Means|-1.2||||0.0175|TWO_SIDED|95.0|-2.2|-0.2||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.2|-2.2|0.0175
91728033|NCT01557244|183351976|OTHER||Difference in LS Mean|-3.82|||||TWO_SIDED|95.0|-45.87|38.23||||||||38.23|-45.87|
91728034|NCT01557244|183351977|SUPERIORITY|||||||0.2334|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.2334
91728035|NCT01557244|183351977|SUPERIORITY|||||||0.5087|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.5087
91728036|NCT01557244|183351977|SUPERIORITY|||||||0.3333|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.3333
91728037|NCT01557244|183351977|OTHER||Difference in LS Mean|-0.47|||||TWO_SIDED|95.0|-7.28|6.33||||||||6.33|-7.28|
91728038|NCT01557244|183351977|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-5.96|7.6||||||||7.60|-5.96|
91728039|NCT01557244|183351979|SUPERIORITY|||||||0.0336|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0336
91728040|NCT01557244|183351979|SUPERIORITY|||||||0.0327|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0327
91728041|NCT01557244|183351979|SUPERIORITY|||||||0.0017|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0017
91728042|NCT01557244|183351979|OTHER||Difference in LS Mean|-10.78|||||TWO_SIDED|95.0|-48.75|27.19||||||||27.19|-48.75|
91728043|NCT01557244|183351979|OTHER||Difference in LS Mean|-15.25|||||TWO_SIDED|95.0|-50.15|19.64||||||||19.64|-50.15|
91696702|NCT03307252|183287464|OTHER||Adjusted gMean Ratio|130.94|STANDARD_ERROR_OF_MEAN|13.6|||TWO_SIDED|90.0|119.82|143.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.10|119.82|
91696703|NCT03307252|183287464|OTHER||Adjusted gMean Ratio|107.42|STANDARD_ERROR_OF_MEAN|12.9|||TWO_SIDED|90.0|97.57|118.27|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.27|97.57|
91696704|NCT03307252|183287465|OTHER||Adjusted geometric mean (gMean) ratio|106.78|STANDARD_ERROR_OF_MEAN|15.5|||TWO_SIDED|90.0|96.51|118.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.15|96.51|
91696705|NCT03307252|183287465|OTHER||Adjusted gMean ratio|271.63|STANDARD_ERROR_OF_MEAN|15.9|||TWO_SIDED|90.0|246.74|299.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|299.03|246.74|
91696706|NCT03307252|183287465|OTHER||Adjusted gMean Ratio|100.8|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|90.0|94.62|107.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.39|94.62|
91696707|NCT03307252|183287465|OTHER||Adjusted gMean Ratio|223.24|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|203.79|244.55|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|244.55|203.79|
91696708|NCT03307252|183287466|OTHER||Adjusted geometric mean (gMean) ratio|121.64|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|100.43|147.33|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|147.33|100.43|
91696709|NCT03307252|183287466|OTHER||Adjusted gMean ratio|95.18|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|83.03|109.11|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.11|83.03|
91696710|NCT03307252|183287466|OTHER||Adjusted gMean Ratio|80.19|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|73.01|88.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|88.08|73.01|
91728044|NCT01557244|183351980|SUPERIORITY|||||||0.0679|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0679
91728045|NCT01557244|183351980|SUPERIORITY|||||||0.1233|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.1233
91728046|NCT01557244|183351980|SUPERIORITY|||||||0.0019|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0019
91728047|NCT01557244|183351980|OTHER||Difference in LS Mean|-4.96|||||TWO_SIDED|95.0|-14.81|4.89||||||||4.89|-14.81|
91728048|NCT01557244|183351980|OTHER||Difference in LS Mean|-5.95|||||TWO_SIDED|95.0|-15.85|3.95||||||||3.95|-15.85|
91728049|NCT01557244|183351981|SUPERIORITY|||||||0.0116|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0116
91728050|NCT01557244|183351981|SUPERIORITY|||||||0.0765|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0765
91728051|NCT01557244|183351981|SUPERIORITY|||||||0.0061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0061
91728052|NCT01557244|183351981|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.16|0.97||||||||0.97|-1.16|
91728053|NCT01557244|183351981|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.74|1.31||||||||1.31|-0.74|
91728054|NCT01557244|183351982|SUPERIORITY|||||||0.0787|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0787
91728055|NCT01557244|183351982|SUPERIORITY|||||||0.0727|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0727
91728056|NCT01557244|183351982|SUPERIORITY|||||||0.0666|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0666
91728057|NCT01557244|183351982|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.45|0.54||||||||0.54|-0.45|
91728058|NCT01557244|183351982|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.49|0.52||||||||0.52|-0.49|
91728059|NCT01557244|183351983|SUPERIORITY|||||||0.0111|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0111
91728060|NCT01557244|183351983|SUPERIORITY|||||||0.0171|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0171
91728061|NCT01557244|183351983|SUPERIORITY|||||||0.0028|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0028
91728062|NCT01557244|183351983|OTHER||Difference in LS Mean|0.14|||||TWO_SIDED|95.0|-0.53|0.82||||||||0.82|-0.53|
91728063|NCT01557244|183351983|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.54|0.84||||||||0.84|-0.54|
91728064|NCT01557244|183351984|SUPERIORITY|||||||0.0496|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0496
91728065|NCT01557244|183351984|SUPERIORITY|||||||0.0002|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0002
91728066|NCT01557244|183351984|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||<.0001
91728067|NCT01557244|183351984|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.09|1.19||||||||1.19|-0.09|
91728068|NCT01557244|183351984|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.52|0.77||||||||0.77|-0.52|
91728069|NCT01557244|183351985|SUPERIORITY|||||||0.0298|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.0298
91728070|NCT01557244|183351985|SUPERIORITY|||||||0.1417|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.1417
91728071|NCT01557244|183351985|SUPERIORITY|||||||0.6219|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.6219
91728072|NCT01557244|183351985|OTHER||Difference in LS Mean|-0.48|||||TWO_SIDED|95.0|-1.28|0.32||||||||0.32|-1.28|
91728073|NCT01557244|183351985|OTHER||Difference in LS Mean|-0.36|||||TWO_SIDED|95.0|-1.24|0.52||||||||0.52|-1.24|
91728074|NCT01557244|183351986|SUPERIORITY|||||||0.7986|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7986
91728075|NCT01557244|183351986|SUPERIORITY|||||||0.2313|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.2313
91728076|NCT01557244|183351986|SUPERIORITY|||||||0.7571|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7571
91728077|NCT01557244|183351986|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-42.11|42.0||||||||42.00|-42.11|
91696711|NCT03307252|183287466|OTHER||Adjusted gMean Ratio|115.39|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|93.8|141.94|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|141.94|93.80|
91696712|NCT03307252|183287467|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
91696713|NCT03307252|183287467|OTHER||Adjusted gMean ratio|135.07|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|117.83|154.84|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|154.84|117.83|
91696714|NCT03307252|183287467|OTHER||Adjusted gMean Ratio|112.31|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|102.26|123.35|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|123.35|102.26|
91696715|NCT03307252|183287467|OTHER||Adjusted gMean Ratio|1125.1|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|914.63|1384.0|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|1384.00|914.63|
91696716|NCT03307252|183287468|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
91696717|NCT03307252|183287468|OTHER||Adjusted gMean ratio|104.78|STANDARD_ERROR_OF_MEAN|21.0|||TWO_SIDED|90.0|89.97|122.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|122.03|89.97|
91696718|NCT03307252|183287468|OTHER||Adjusted gMean Ratio|122.65|STANDARD_ERROR_OF_MEAN|20.1|||TWO_SIDED|90.0|107.68|139.69|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|139.69|107.68|
91696719|NCT03307252|183287468|OTHER||Adjusted gMean Ratio|116.88|STANDARD_ERROR_OF_MEAN|14.4|||TWO_SIDED|90.0|105.07|130.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.03|105.07|
91728078|NCT01557244|183351986|OTHER||Difference in LS Mean|15.07|||||TWO_SIDED|95.0|-26.5|56.63||||||||56.63|-26.50|
91728079|NCT01557244|183351987|SUPERIORITY|||||||0.061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0610
91728080|NCT01557244|183351987|SUPERIORITY|||||||0.0048|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0048
91728081|NCT01557244|183351987|SUPERIORITY|||||||0.01|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0100
91728082|NCT01557244|183351987|OTHER||Difference in LS Mean|-16.43|||||TWO_SIDED|95.0|-63.14|30.29||||||||30.29|-63.14|
91728083|NCT01557244|183351987|OTHER||Difference in LS Mean|1.28|||||TWO_SIDED|95.0|-46.0|48.57||||||||48.57|-46.00|
91728084|NCT01557244|183351988|SUPERIORITY|||||||0.2246|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.2246
91728085|NCT01557244|183351988|SUPERIORITY|||||||0.0003|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0003
91728086|NCT01557244|183351988|SUPERIORITY|||||||0.0161|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0161
91728087|NCT01557244|183351988|OTHER||Difference in LS Mean|-18.24|||||TWO_SIDED|95.0|-61.0|24.53||||||||24.53|-61.00|
91696720|NCT03307252|183287469|OTHER||Adjusted geometric mean (gMean) ratio|87.07|STANDARD_ERROR_OF_MEAN|20.9|||TWO_SIDED|90.0|76.08|99.64|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.64|76.08|
91490725|NCT02165215|182854276|SUPERIORITY||Difference in Adjusted Mean|2.1||||0.6331|TWO_SIDED|95.0|-6.6|10.8||p-value has not been adjusted for multiplicity|ANCOVA|||||10.8|-6.6|0.6331
91696721|NCT03307252|183287469|OTHER||Adjusted gMean ratio|122.94|STANDARD_ERROR_OF_MEAN|18.0|||TWO_SIDED|90.0|110.25|137.09|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|137.09|110.25|
91696722|NCT03307252|183287469|OTHER||Adjusted gMean Ratio|101.35|STANDARD_ERROR_OF_MEAN|12.0|||TWO_SIDED|90.0|93.65|109.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.70|93.65|
91696723|NCT03307252|183287469|OTHER||Adjusted gMean Ratio|428.23|STANDARD_ERROR_OF_MEAN|26.8|||TWO_SIDED|90.0|359.78|509.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|509.70|359.78|
91696724|NCT03307252|183287470|OTHER||Adjusted gMean ratio|92.24|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|85.28|99.76|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.76|85.28|
91696725|NCT03307252|183287470|OTHER||Adjusted gMean Ratio|83.99|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|78.32|90.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|90.08|78.32|
91696726|NCT03307252|183287470|OTHER||Adjusted gMean Ratio|124.06|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|105.11|146.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|146.43|105.11|
91728088|NCT01557244|183351988|OTHER||Difference in LS Mean|18.86|||||TWO_SIDED|95.0|-22.93|60.65||||||||60.65|-22.93|
91728089|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.137|TWO_SIDED|95.0|0.739|1.042|||Cox Proportional Hazards Model|||||1.042|0.739|0.137
91728090|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|12.2|||||TWO_SIDED|95.0|-4.2|26.1|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||26.1|-4.2|
91728091|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.284|TWO_SIDED|95.0|0.767|1.081|||Cox Proportional Hazards Model|||||1.081|0.767|0.284
91728092|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.9|||||TWO_SIDED|95.0|-8.1|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.1|
91728093|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.962||||0.655|TWO_SIDED|95.0|0.813|1.139|||Cox Proportional Hazards Model|||||1.139|0.813|0.655
91728094|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.8|||||TWO_SIDED|95.0|-13.9|18.7|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||18.7|-13.9|
91728095|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.681|TWO_SIDED|95.0|0.808|1.149|||Cox Proportional Hazards Model|||||1.149|0.808|0.681
91696727|NCT03307252|183287471|OTHER||Adjusted gMean Ratio|112.73|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|104.23|121.92|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|121.92|104.23|
91696728|NCT03307252|183287471|OTHER||Adjusted gMean Ratio|108.56|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|101.22|116.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|116.43|101.22|
91696729|NCT03307252|183287471|OTHER||Adjusted gMean Ratio|340.67|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|288.63|402.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|402.10|288.63|
91728096|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.6|||||TWO_SIDED|95.0|-14.9|19.2|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.2|-14.9|
91728097|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.299|TWO_SIDED|95.0|0.767|1.085|||Cox Proportional Hazards Model|||||1.085|0.767|0.299
91728098|NCT01313676|183352024|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.8|||||TWO_SIDED|95.0|-8.5|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.5|
91728099|NCT01313676|183352025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.019|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||||15|1|0.019
91728100|NCT01313676|183352025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.5||0.026|TWO_SIDED|95.0|1.0|14.0|||Mixed Models Analysis|||||14|1|0.026
91728101|NCT01313676|183352025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.4||0.654|TWO_SIDED|95.0|-8.0|5.0|||Mixed Models Analysis|||||5|-8|0.654
91728102|NCT01313676|183352025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|3.4||0.913|TWO_SIDED|95.0|-6.0|7.0|||Mixed Models Analysis|||||7|-6|0.913
91728103|NCT01313676|183352025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|3.4||0.004|TWO_SIDED|95.0|3.0|16.0|||Mixed Models Analysis|||||16|3|0.004
91728104|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.926||||0.475|TWO_SIDED|95.0|0.75|1.143|||Cox Proportional Hazards Model|||||1.143|0.750|0.475
91728105|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|7.4|||||TWO_SIDED|95.0|-14.3|25.0|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||25.0|-14.3|
91728106|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.317|TWO_SIDED|95.0|0.723|1.111|||Cox Proportional Hazards Model|||||1.111|0.723|0.317
91728107|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|10.4|||||TWO_SIDED|95.0|-11.1|27.7|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||27.7|-11.1|
91728108|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.908|TWO_SIDED|95.0|0.802|1.217|||Cox Proportional Hazards Model|||||1.217|0.802|0.908
91728109|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|1.2|||||TWO_SIDED|95.0|-21.7|19.8|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.8|-21.7|
91696730|NCT03307252|183287472|OTHER||Adjusted gMean ratio|100.78|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|93.59|108.51|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.51|93.59|
91490726|NCT00592384|182854295|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary comparisons|Mixed Models Analysis|see above||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
91696731|NCT03307252|183287472|OTHER||Adjusted gMean Ratio|131.37|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|120.37|143.37|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.37|120.37|
91696732|NCT03307252|183287472|OTHER||Adjusted gMean Ratio|106.55|STANDARD_ERROR_OF_MEAN|12.8|||TWO_SIDED|90.0|96.87|117.19|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.19|96.87|
91696733|NCT03307252|183287473|OTHER||Adjusted gMean ratio|260.11|STANDARD_ERROR_OF_MEAN|14.7|||TWO_SIDED|90.0|237.96|284.32|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|284.32|237.96|
91696734|NCT03307252|183287473|OTHER||Adjusted gMean Ratio|101.21|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|95.15|107.66|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.66|95.15|
91696735|NCT03307252|183287473|OTHER||Adjusted gMean Ratio|215.28|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|90.0|197.53|234.63|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|234.63|197.53|
91696736|NCT01052480|183287474|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
91696737|NCT01578239|183287496|SUPERIORITY||Hazard Ratio (HR)|0.177|||<|0.0001|TWO_SIDED|95.0|0.108|0.289||Derived from a two-sided test between the two groups|Log Rank||Hazard ratio is expressed as Lu-DOTA-Tyr-Octreotate / Octreotide LAR and estimated from the corresponding Cox model.|||0.289|0.108|<0.0001
91490727|NCT00592384|182854308|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary outcomes|Mixed Models Analysis|||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
91696738|NCT01578239|183287497|SUPERIORITY|||||||0.0141|||||||Fisher Exact|||||||0.0141
91696739|NCT01578239|183287498|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank|||||1.17|0.60|0.3039
91696740|NCT01578239|183287499|SUPERIORITY||Cox Proportional Hazard|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR|||1.17|0.60|0.3039
91696741|NCT01578239|183287500|SUPERIORITY||Hazard Ratio (HR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.077|0.242|||Log Rank|||||0.242|0.077|<0.0001
91696742|NCT02347813|183287506|OTHER||Mean Difference (Final Values)|0.5||||0.75|TWO_SIDED|95.0|||||ANOVA|||||||0.750
91696743|NCT00251303|183287594|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Chi-squared|||||||0.959
91696744|NCT01106677|183287605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.758|-0.481|||ANCOVA|||||-0.481|-0.758|<0.001
91696745|NCT01106677|183287605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.914|-0.636|||ANCOVA|||||-0.636|-0.914|<0.001
91696746|NCT01106677|183287605|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.795|-0.516||No formal statistical comparison was conducted.|ANCOVA|||||-0.516|-0.795|
91696747|NCT01106677|183287606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.001|TWO_SIDED|95.0|1.5|3.5|||Regression, Logistic|||||3.50|1.50|<0.001
91696748|NCT01106677|183287606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.85|6.77|||Regression, Logistic|||||6.77|2.85|<0.001
91696749|NCT01106677|183287607|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.8|STANDARD_ERROR_OF_MEAN|3.044|<|0.001|TWO_SIDED|95.0|-35.76|-23.81|||ANCOVA|||||-23.81|-35.76|<0.001
91696750|NCT01106677|183287607|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-40.3|STANDARD_ERROR_OF_MEAN|3.055|<|0.001|TWO_SIDED|95.0|-46.25|-34.26|||ANCOVA|||||-34.26|-46.25|<0.001
91696751|NCT01106677|183287607|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-28.7|-16.69||No formal statistical comparison was conducted.|ANCOVA|||||-16.69|-28.70|
91728110|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.763|TWO_SIDED|95.0|0.834|1.281|||Cox Proportional Hazards Model|||||1.281|0.834|0.763
91728111|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|-3.3|||||TWO_SIDED|95.0|-28.1|16.6|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||16.6|-28.1|
91728112|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.545|TWO_SIDED|95.0|0.761|1.155|||Cox Proportional Hazards Model|||||1.155|0.761|0.545
91696752|NCT01106677|183287608|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|5.601|<|0.001|TWO_SIDED|95.0|-49.14|-27.16|||ANCOVA|||||-27.16|-49.14|<0.001
91696753|NCT01106677|183287608|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|5.635|<|0.001|TWO_SIDED|95.0|-58.4|-36.29|||ANCOVA|||||-36.29|-58.40|<0.001
91696754|NCT01106677|183287608|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-39.6|STANDARD_ERROR_OF_MEAN|5.608|||TWO_SIDED|95.0|-50.56|-28.55||No formal statistical comparison was conducted.|ANCOVA|||||-28.55|-50.56|
91696755|NCT01106677|183287609|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.1|-1.9|||ANCOVA|||||-1.9|-3.1|<0.001
91696756|NCT01106677|183287609|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.3|||ANCOVA|||||-2.3|-3.5|<0.001
91696757|NCT01106677|183287609|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.6||No formal statistical comparison was conducted.|ANCOVA|||||0.6|-0.6|
91696758|NCT01106677|183287610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|0.979|<|0.001|TWO_SIDED|95.0|-7.28|-3.439|||ANCOVA|||||-3.439|-7.280|<0.001
91696759|NCT01106677|183287610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-8.504|-4.653|||ANCOVA|||||-4.653|-8.504|<0.001
91696760|NCT01106677|183287610|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|0.984|||TWO_SIDED|95.0|-5.273|-1.413||No formal statistical comparison was conducted.|ANCOVA|||||-1.413|-5.273|
91696761|NCT01106677|183287611|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|4.2||0.702||95.0|-9.9|6.7|||ANCOVA|||||6.7|-9.9|0.702
91728113|NCT01313676|183352026|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|6.2|||||TWO_SIDED|95.0|-15.5|23.9|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.9|-15.5|
91728114|NCT01654250|183352029|SUPERIORITY_OR_OTHER||Least Square(LS) Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-10.9|-3.1|||Mixed Models Analysis|||Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.1|-10.9|<0.001
91728115|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.7|-3.7|||Mixed Models Analysis|||Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.7|-12.7|<0.001
91696762|NCT01106677|183287611|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|4.3||0.274|TWO_SIDED|95.0|-13.0|3.7|||ANCOVA|||||3.7|-13.0|0.274
91728116|NCT01654250|183352030|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
91728117|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-17.3|-8.3|||Mixed Models Analysis|||Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-8.3|-17.3|<0.001
91696763|NCT01106677|183287611|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-10.6|6.1||No formal statistical comparison was conducted.|ANCOVA|||||6.1|-10.6|
91696764|NCT01106677|183287612|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.6|9.7|||ANCOVA|||||9.7|3.6|<0.001
91696765|NCT01106677|183287612|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|8.5|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|5.4|11.5|||ANCOVA|||||11.5|5.4|<0.001
91696766|NCT01106677|183287612|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-1.7|4.4||No formal statistical comparison was conducted.|ANCOVA|||||4.4|-1.7|
91696767|NCT01106677|183287613|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.061|||TWO_SIDED|95.0|-0.119|0.122|||ANCOVA|||||0.122|-0.119|
91696768|NCT01106677|183287613|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|-0.273|-0.031|||ANCOVA|||||-0.031|-0.273|
91696769|NCT01106677|183287614|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|2.394|<|0.001|TWO_SIDED|95.0|-13.25|-3.857|||ANCOVA|||||-3.857|-13.25|<0.001
91696770|NCT01106677|183287614|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-17.5|STANDARD_ERROR_OF_MEAN|2.404|<|0.001|TWO_SIDED|95.0|-22.24|-12.81|||ANCOVA|||||-12.81|-22.24|<0.001
91696771|NCT01106677|183287615|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.8|||ANCOVA|||||-1.8|-3.0|<0.001
91696772|NCT01106677|183287615|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.4|-2.3|||ANCOVA|||||-2.3|-3.4|<0.001
91696773|NCT01106677|183287616|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-4.464|-1.276|||ANCOVA|||||-1.276|-4.464|<0.001
91728118|NCT01654250|183352030|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
91696774|NCT01106677|183287616|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.99|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.589|-2.389|||ANCOVA|||||-2.389|-5.589|<0.001
91696775|NCT01106677|183287617|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|3.2||0.466|TWO_SIDED|95.0|-3.9|8.5|||ANCOVA|||||8.5|-3.9|0.466
91696776|NCT01106677|183287617|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.2||0.323|TWO_SIDED|95.0|-3.1|9.4|||ANCOVA|||||9.4|-3.1|0.323
91696777|NCT01106677|183287618|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.5|8.0|||ANCOVA|||||8.0|2.5|<0.001
91696778|NCT01106677|183287618|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|4.5|10.1|||ANCOVA|||||10.1|4.5|<0.001
91696779|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.998|||||TWO_SIDED|95.0|2.659|6.009||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.009|2.659|
91728119|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-16.8|-7.8|||Mixed Models Analysis|||Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-7.8|-16.8|<0.001
91728120|NCT01654250|183352030|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
91758797|NCT00265317|183410819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.9198|TWO_SIDED|95.0|0.365|2.489||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||2.489|0.365|0.9198
91758798|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.9486|TWO_SIDED|95.0|0.473|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.014|0.473|0.9486
91758799|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.9084|TWO_SIDED|95.0|0.487|1.897||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.897|0.487|0.9084
91758800|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.876||||0.2009|TWO_SIDED|95.0|0.534|15.48||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||15.48|0.534|0.2009
91728121|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.3|-3.3|||Mixed Models Analysis|||Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.||-3.3|-12.3|<0.001
91728122|NCT01654250|183352030|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
91728123|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.28||0.133|TWO_SIDED|95.0|-7.9|1.1|||Mixed Models Analysis|||Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.1|-7.9|0.133
91728124|NCT01654250|183352030|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
91728125|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.28||0.206|TWO_SIDED|95.0|-7.4|1.6|||Mixed Models Analysis|||Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.6|-7.4|0.206
91490728|NCT01153347|182854311|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|1.07||1|TWO_SIDED|95.0|-2.96|1.24||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.24|-2.96|1.000
91728126|NCT01654250|183352030|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
91728127|NCT01654250|183352030|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.28||0.496|TWO_SIDED|95.0|-6.0|2.9|||Mixed Models Analysis|||Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||2.9|-6.0|0.496
91728128|NCT01654250|183352030|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
91728129|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.56||0.007|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.4|-2.6|0.007
91728130|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.4|-3.6|<0.001
91728131|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.4|-1.2|||Mixed Models Analysis|||Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.2|-3.4|<0.001
91490729|NCT01153347|182854311|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|1.08||1|TWO_SIDED|95.0|-2.67|1.57|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.57|-2.67|1.000
91728132|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.56||0.003|TWO_SIDED|95.0|-2.8|-0.6|||Mixed Models Analysis|||Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.6|-2.8|0.003
91728133|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56||0.097|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis|||Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.2|-2.0|0.097
91728134|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.49|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.7|-1.5|0.490
91490730|NCT01153347|182854311|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|1.09||1|TWO_SIDED|95.0|-2.26|2.04|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.04|-2.26|1.000
91728135|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.164|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.3|-1.9|0.164
91728136|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.94||0.004|TWO_SIDED|95.0|-4.6|-0.9|||Mixed Models Analysis|||Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.9|-4.6|0.004
91728137|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
91728138|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
91490731|NCT01153347|182854312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.24||0.967|TWO_SIDED|95.0|0.64|1.6|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.60|0.64|0.967
91490732|NCT01153347|182854312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.21||0.67|TWO_SIDED|95.0|0.57|1.43|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.43|0.57|0.670
91490733|NCT01153347|182854312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.544|TWO_SIDED|95.0|0.54|1.38|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.38|0.54|0.544
91490734|NCT01153347|182854313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.24||0.73|TWO_SIDED|95.0|0.55|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.53|0.55|0.730
91490735|NCT01153347|182854313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.23||0.671|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.53|0.671
91728139|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.94||0.042|TWO_SIDED|95.0|-3.8|-0.1|||Mixed Models Analysis|||Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.1|-3.8|0.042
91728140|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.94||0.118|TWO_SIDED|95.0|-3.3|0.4|||Mixed Models Analysis|||Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.4|-3.3|0.118
91728141|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.94||0.342|TWO_SIDED|95.0|-2.7|1.9|||Mixed Models Analysis|||Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-2.7|0.342
91490736|NCT01153347|182854313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.2||0.308|TWO_SIDED|95.0|0.45|1.29|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.29|0.45|0.308
91490737|NCT01153347|182854314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.4||0.905|TWO_SIDED|95.0|0.42|2.15|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.15|0.42|0.905
91490738|NCT01153347|182854314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.39||0.864|TWO_SIDED|95.0|0.41|2.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.14|0.41|0.864
91490739|NCT01153347|182854314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.42||0.958|TWO_SIDED|95.0|0.43|2.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.25|0.43|0.958
91490740|NCT01153347|182854315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.778|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.73|0.48|0.778
91490741|NCT01153347|182854315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|STANDARD_ERROR_OF_MEAN|0.38||0.532|TWO_SIDED|95.0|0.66|2.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.24|0.66|0.532
91490742|NCT01153347|182854315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.29||0.633|TWO_SIDED|95.0|0.44|1.64|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.64|0.44|0.633
91728142|NCT01654250|183352031|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.962|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis|||Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-1.8|0.962
91728143|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean difference|25.3|STANDARD_ERROR_OF_MEAN|11.12||0.024|TWO_SIDED|95.0|3.4|47.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||47.1|3.4|0.024
91490743|NCT01153347|182854316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.42||0.949|TWO_SIDED|95.0|0.46|2.31|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.31|0.46|0.949
91696780|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.222|||||TWO_SIDED|95.0|0.813|1.838||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.838|0.813|
91696781|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.661|||||TWO_SIDED|95.0|0.44|0.994||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.994|0.440|
91696782|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.178|||||TWO_SIDED|95.0|1.449|3.276||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.276|1.449|
91696783|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.017|||||TWO_SIDED|95.0|0.676|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.676|
91696784|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.673|||||TWO_SIDED|95.0|0.448|1.012||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.012|0.448|
91696785|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.742|||||TWO_SIDED|95.0|1.156|2.626||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.626|1.156|
91728144|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|11.12||0.001|TWO_SIDED|95.0|14.2|57.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||57.9|14.2|0.001
91758801|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.098||||0.7863|TWO_SIDED|95.0|0.554|2.175||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305845 Genotype: G/G||2.175|0.554|0.7863
91696786|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.306|||||TWO_SIDED|95.0|0.204|0.458||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.458|0.204|
91696787|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.165|||||TWO_SIDED|95.0|0.11|0.248||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.248|0.110|
91696788|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.545|||||TWO_SIDED|95.0|0.363|0.818||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.818|0.363|
91490744|NCT01153347|182854316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|STANDARD_ERROR_OF_MEAN|0.62||0.253|TWO_SIDED|95.0|0.72|3.4|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.40|0.72|0.253
91696789|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.254|||||TWO_SIDED|95.0|0.17|0.381||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.381|0.170|
91490745|NCT01153347|182854316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|STANDARD_ERROR_OF_MEAN|0.39||0.763|TWO_SIDED|95.0|0.37|2.08|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.08|0.37|0.763
91705434|NCT03924505|183305391|SUPERIORITY||Incidence Rate Ratio|2.15|||<|0.01|TWO_SIDED|95.0|1.42|2.35||A priori threshold for statistical significance set at p\<0.05|Negative Binomial Regression|We adjusted for baseline rate due to baseline differences.|The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||2.35|1.42|<0.01
91705435|NCT03924505|183305392|SUPERIORITY||Incidence Rate Ratio|1.97||||0.01|TWO_SIDED|95.0|1.18|3.3||A priori threshold for statistical signicance is p\<0.05|Negative Binomial Regression||The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||3.30|1.18|0.01
91705436|NCT03924505|183305393|OTHER|Testing for differences in means|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.68|TWO_SIDED|95.0|-0.7|1.0|||t-test, 2 sided|||||1.0|-0.7|0.68
91705437|NCT03743402|183305419|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in MME/day between arms.|Mean Difference (Final Values)|-2.54||||0.58|TWO_SIDED|95.0|-10.55|5.88|||Regression, Linear||mean difference=(pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect an average 24 MME/day difference between arms.||5.88|-10.55|0.58
91705438|NCT03743402|183305420|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in PEG score between arms.|Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.51|0.52|||Regression, Linear||mean difference = (pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect a 1.2-point average difference in PEG score between arms.||0.52|-0.51|0.98
91705439|NCT03743402|183305421|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in average MME/day between arms.|Mean Difference (Final Values)|1.3||||0.72|TWO_SIDED|95.0|-5.69|8.29|||Regression, Linear||mean difference=(pain self-management)-(usual care)|||8.29|-5.69|0.72
91705440|NCT03743402|183305422|EQUIVALENCE|The null hypothesis is a point null of exactly 0 difference in expected PEG score between arms.|Mean Difference (Final Values)|-0.53||||0.07|TWO_SIDED|95.0|-1.11|0.05|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.05|-1.11|0.07
91705441|NCT03743402|183305423|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|2.11||||0.8|TWO_SIDED|95.0|-13.83|18.04|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||18.04|-13.83|0.80
91705442|NCT03743402|183305424|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|4.33||||0.02|TWO_SIDED|95.0|0.56|8.09|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||8.09|0.56|0.02
91705443|NCT03743402|183305425|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.35||||0.75|TWO_SIDED|95.0|-2.53|1.82|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.82|-2.53|0.75
91705444|NCT03743402|183305426|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.87|0.87|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.87|-1.87|0.48
91705445|NCT03743402|183305427|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|-0.25||||0.64|TWO_SIDED|95.0|-1.31|0.81|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.81|-1.31|0.64
91705446|NCT03743402|183305428|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|0.28||||0.65|TWO_SIDED|95.0|-0.94|1.51|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.51|-0.94|0.65
91705447|NCT03743402|183305429|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|0.61||||0.02|TWO_SIDED|95.0|0.12|1.1|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.10|0.12|0.02
91696790|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.168|||||TWO_SIDED|95.0|0.112|0.252||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.252|0.112|
91696791|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.436|||||TWO_SIDED|95.0|0.29|0.655||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.655|0.290|
91696792|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.541|||||TWO_SIDED|95.0|0.361|0.811||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.811|0.361|
91490746|NCT01153347|182854317|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.207|TWO_SIDED|95.0|-2.51|0.55|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.55|-2.51|0.207
91490747|NCT01153347|182854317|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.427|TWO_SIDED|95.0|-2.16|0.91|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.91|-2.16|0.427
91490748|NCT01153347|182854317|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.78||0.591|TWO_SIDED|95.0|-1.96|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-1.96|0.591
91490749|NCT01153347|182854318|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.551||95.0|-0.34|0.18|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.18|-0.34|0.551
91696793|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.783|||||TWO_SIDED|95.0|1.188|2.676||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.676|1.188|
91705448|NCT03743402|183305430|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|1.33|||<|0.01|TWO_SIDED|95.0|0.77|1.88|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.88|0.77|<0.01
91705449|NCT03743402|183305431|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.09||||0.42|TWO_SIDED|95.0|-0.13|0.31|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.31|-0.13|0.42
91705450|NCT03743402|183305432|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.13||||0.26|TWO_SIDED|95.0|-0.1|0.36|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.36|-0.10|0.26
91705451|NCT03743402|183305433|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|1.6||||0.54|TWO_SIDED|95.0|-3.47|6.66|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||6.66|-3.47|0.54
91705452|NCT03743402|183305434|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|0.48||||0.59|TWO_SIDED|95.0|-1.26|2.21|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||2.21|-1.26|0.59
91705453|NCT03743402|183305435|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in opioid craving score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.66|0.57|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.57|-0.66|0.90
91705454|NCT03743402|183305436|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|-0.35||||0.3|TWO_SIDED|95.0|-1.03|0.32|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.32|-1.03|0.30
91705455|NCT03743402|183305437|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|2.1||||0.2|TWO_SIDED|95.0|0.68|6.53|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||6.53|0.68|0.20
91705456|NCT03743402|183305438|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|1.34||||0.53|TWO_SIDED|95.0|0.54|3.32|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||3.32|0.54|0.53
91705457|NCT03411902|183305445|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
91728145|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|34.7|STANDARD_ERROR_OF_MEAN|11.12||0.002|TWO_SIDED|95.0|12.8|56.6|||Mixed Models Analysis|||Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.6|12.8|0.002
91728146|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|11.12||0.009|TWO_SIDED|95.0|7.4|51.1|||Mixed Models Analysis|||Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||51.1|7.4|0.009
91728147|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|11.12||0.261|TWO_SIDED|95.0|-9.3|34.4|||Mixed Models Analysis|||Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||34.4|-9.3|0.261
91728148|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|11.12||0.175|TWO_SIDED|95.0|-6.7|37.0|||Mixed Models Analysis|||Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||37.0|-6.7|0.175
91728149|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|18.7|STANDARD_ERROR_OF_MEAN|11.12||0.094|TWO_SIDED|95.0|-3.2|40.5|||Mixed Models Analysis|||Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||40.5|-3.2|0.094
91728150|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6|STANDARD_ERROR_OF_MEAN|11.44||0.049|TWO_SIDED|95.0|0.1|45.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||45.1|0.1|0.049
91728151|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4|STANDARD_ERROR_OF_MEAN|11.44||0.003|TWO_SIDED|95.0|11.9|56.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.9|11.9|0.003
91728152|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|STANDARD_ERROR_OF_MEAN|11.44||0.004|TWO_SIDED|95.0|10.5|55.4|||Mixed Models Analysis|||Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||55.4|10.5|0.004
91490750|NCT01153347|182854318|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.487|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.17|-0.36|0.487
91490751|NCT01153347|182854318|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.78|TWO_SIDED|95.0|-0.23|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.23|0.780
91728153|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|11.44||0.019|TWO_SIDED|95.0|4.5|49.5|||Mixed Models Analysis|||Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||49.5|4.5|0.019
91728154|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean difference|8.6|STANDARD_ERROR_OF_MEAN|11.44||0.451|TWO_SIDED|95.0|-13.9|31.1|||Mixed Models Analysis|||Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||31.1|-13.9|0.451
91728155|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|11.44||0.394|TWO_SIDED|95.0|-12.7|32.2|||Mixed Models Analysis|||Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||32.2|-12.7|0.394
91490752|NCT01153347|182854319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.23||0.908|TWO_SIDED|95.0|0.62|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.53|0.62|0.908
91490753|NCT01153347|182854319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.24||0.803|TWO_SIDED|95.0|0.67|1.67|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.67|0.67|0.803
91490754|NCT01153347|182854319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|0.41|1.03|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.03|0.41|0.066
91490755|NCT01153347|182854320|SUPERIORITY_OR_OTHER||LS mean|-0.82|STANDARD_ERROR_OF_MEAN|0.645||0.202|TWO_SIDED|95.0|-2.091|0.442|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.442|-2.091|0.202
91490756|NCT01153347|182854320|SUPERIORITY_OR_OTHER||LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.647||0.738|TWO_SIDED|95.0|-1.487|1.055|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.055|-1.487|0.738
91490757|NCT01153347|182854320|SUPERIORITY_OR_OTHER||LS mean|-0.51|STANDARD_ERROR_OF_MEAN|0.65||0.433|TWO_SIDED|95.0|-1.787|0.767|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.767|-1.787|0.433
91490758|NCT01153347|182854321|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.097|TWO_SIDED|95.0|-0.18|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.18|0.097
91490759|NCT01153347|182854321|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.882|TWO_SIDED|95.0|-1.29|1.11|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-1.29|0.882
91490760|NCT01153347|182854321|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1|TWO_SIDED|95.0|-0.19|2.23|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.23|-0.19|0.100
91490761|NCT01153347|182854322|SUPERIORITY_OR_OTHER||LS mean|0.8|STANDARD_ERROR_OF_MEAN|0.74||0.303|TWO_SIDED|95.0|-0.69|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.69|0.303
91696794|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.832|||||TWO_SIDED|95.0|0.555|1.246||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.246|0.555|
91696795|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.551|||||TWO_SIDED|95.0|0.367|0.826||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.826|0.367|
91696796|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.426|||||TWO_SIDED|95.0|0.95|2.14||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.140|0.950|
91696797|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.295|||||TWO_SIDED|95.0|2.196|4.944||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.944|2.196|
91705458|NCT03411902|183305446|SUPERIORITY|||||||0.745|||||||Mixed Models Analysis|||||||0.745
91705459|NCT03411902|183305447|SUPERIORITY|||||||0.163|||||||Mixed Models Analysis|||||||0.163
91705460|NCT03411902|183305448|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
91705461|NCT03411902|183305449|SUPERIORITY|||||||0.337|||||||Mixed Models Analysis|||Pertaining to Radius 33 BMD||||0.337
91705462|NCT03411902|183305449|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Pertaining to Radius UD BMD||||0.238
91490762|NCT01153347|182854322|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.74||0.793|TWO_SIDED|95.0|-1.26|1.65|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.65|-1.26|0.793
91490763|NCT01153347|182854322|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.75||0.762|TWO_SIDED|95.0|-1.7|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.25|-1.70|0.762
91696798|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.538|||||TWO_SIDED|95.0|1.026|2.303||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.303|1.026|
91696799|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.018|||||TWO_SIDED|95.0|0.679|1.526||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.526|0.679|
91696800|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.635|||||TWO_SIDED|95.0|1.754|3.959||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.959|1.754|
91696801|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.467|||||TWO_SIDED|95.0|0.311|0.7||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.7|0.311|
91696802|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.309|||||TWO_SIDED|95.0|0.206|0.463||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.463|0.206|
91696803|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.8|||||TWO_SIDED|95.0|0.532|1.203||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||1.203|0.532|
91696804|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.662|||||TWO_SIDED|95.0|0.442|0.992||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.992|0.442|
91696805|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.714|||||TWO_SIDED|95.0|1.142|2.572||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.572|1.142|
91696806|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|Geometric mean ratio at day 22|2.589|||||TWO_SIDED|95.0|1.723|3.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.889|1.723|
91728156|NCT01654250|183352032|SUPERIORITY_OR_OTHER||LS Mean difference|8.3|STANDARD_ERROR_OF_MEAN|11.44||0.466|TWO_SIDED|95.0|-14.1|30.8|||Mixed Models Analysis|||Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||30.8|-14.1|0.466
91758802|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.5267|TWO_SIDED|95.0|0.633|2.442||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR2/rs2305945 Genotype: G/T||2.442|0.633|0.5267
91705463|NCT03411902|183305450|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.860
91705464|NCT01693185|183305452|SUPERIORITY_OR_OTHER||||||<|0.001||||||We wished to be able to distinguish a difference of 7.5 min,|Wilcoxon (Mann-Whitney)|||Recovery time in patients administered remifentanil alone will be significantly shorter than that in patients administered midazolam-meperidine combination for colonoscopy.||||< 0.001
91705465|NCT00419159|183305463|OTHER||Odds Ratio (OR)|1.8||||0.253|TWO_SIDED|95.0|0.657|4.929|||Unadjusted Logistic Regression|||||4.929|0.657|0.253
91705466|NCT00419159|183305464|OTHER||Odds Ratio (OR)|0.382||||0.07|TWO_SIDED|95.0|0.135|1.083|||Unadjusted Logistic Regression|||||1.083|0.135|0.070
91705467|NCT00419159|183305465|OTHER||Hazard Ratio (HR)|0.814||||0.399|TWO_SIDED|95.0|0.505|1.312|||Unadjusted Logistic Regression|||||1.312|0.505|0.399
91705468|NCT00419159|183305465|OTHER||Hazard Ratio, log|1.001||||0.995|TWO_SIDED|95.0|0.62|1.617|||Unadjusted Logistic Regression|||||1.617|0.620|0.995
91758803|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.624|TWO_SIDED|95.0|0.049|6.208||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: T/T||6.208|0.049|0.6240
91758804|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.254||||0.4882|TWO_SIDED|95.0|0.66|2.384||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR/rs1870377 Genotype: T/T||2.384|0.660|0.4882
91758805|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587||||0.1307|TWO_SIDED|95.0|0.29|1.189||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||1.189|0.290|0.1307
91758806|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
91758807|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.7966|TWO_SIDED|95.0|0.628|1.833||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.833|0.628|0.7966
91758808|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.9224|TWO_SIDED|95.0|0.366|2.484||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||2.484|0.366|0.9224
91758809|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047||||0.9317|TWO_SIDED|95.0|0.363|3.025||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||3.025|0.363|0.9317
91758810|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.8696|TWO_SIDED|95.0|0.546|2.044||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||2.044|0.546|0.8696
91758811|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8694|TWO_SIDED|95.0|0.453|2.554||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||2.554|0.453|0.8694
91758812|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs3563987 Genotype: C/C||1.652|0.654|0.8708
91758813|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.7667|TWO_SIDED|95.0|0.442|3.026||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||3.026|0.442|0.7667
91758814|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.3822|TWO_SIDED|95.0|0.401|1.422||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.422|0.401|0.3822
91758815|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.419||||0.5089|TWO_SIDED|95.0|0.498|4.04||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||4.040|0.498|0.5089
91758816|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326||||0.3944|TWO_SIDED|95.0|0.691|2.544||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.544|0.691|0.3944
91758817|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.3103|TWO_SIDED|95.0|0.339|1.416||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.416|0.339|0.3103
91758818|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.857||||0.8942|TWO_SIDED|95.0|0.089|8.294||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||8.294|0.089|0.8942
91758819|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.665|TWO_SIDED|95.0|0.466|3.304||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.304|0.466|0.6650
91758820|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779||||0.4415|TWO_SIDED|95.0|0.412|1.475||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.475|0.412|0.4415
91758821|NCT00265317|183410820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.458||||0.4682|TWO_SIDED|95.0|0.523|4.06||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||4.060|0.523|0.4682
91758822|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.289||||0.7301|TWO_SIDED|95.0|0.304|5.47||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||5.470|0.304|0.7301
91758823|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.788||||0.5013|TWO_SIDED|95.0|0.39|1.592||2-sided unstratified log-rank test|Log Rank|||PDGFRB/rs2304060 C/A||1.592|0.390|0.5013
91758824|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.368|TWO_SIDED|95.0|0.298|1.578||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: A/A||1.578|0.298|0.3680
91758825|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.3804|TWO_SIDED|95.0|0.371|1.467||2-sided, unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.467|0.371|0.3804
91758826|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.1507|TWO_SIDED|95.0|0.261|1.247||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||1.247|0.261|0.1507
91758827|NCT00265317|183410822|SUPERIORITY_OR_OTHER|||||||0.0772||||||2-sided unstratified log-rank test|Log Rank|||Locus PDGFRB/rs17656204 Genotype: T/T||||0.0772
91490764|NCT01153347|182854323|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.339|TWO_SIDED|95.0|-2.65|0.92|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.92|-2.65|0.339
91490765|NCT01153347|182854323|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.321|TWO_SIDED|95.0|-2.7|0.89|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.89|-2.70|0.321
91696807|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|4.975|||||TWO_SIDED|95.0|3.757|6.589||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.589|3.757|
91696808|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.168|||||TWO_SIDED|95.0|0.881|1.547||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.547|0.881|
91705469|NCT00419159|183305466|OTHER||Hazard Ratio, log|1.203||||0.441|TWO_SIDED|95.0|0.752|1.923|||Unadjusted Logistic Regression|||||1.923|0.752|0.441
91705470|NCT00419159|183305466|OTHER||Hazard Ratio, log|1.547||||0.126|TWO_SIDED|95.0|0.884|2.708|||Unadjusted Logistic Regression|||||2.708|0.884|0.126
91705471|NCT00419159|183305467|OTHER||Odds Ratio (OR)|0.529||||0.238|TWO_SIDED|95.0|0.184|1.523|||Unadjusted Logistic Regression|||||1.523|0.184|0.238
91705472|NCT00419159|183305468|OTHER||Odds Ratio (OR)|1.044||||0.938|TWO_SIDED|95.0|0.352|3.099|||Unadjusted Logistic Regression|||||3.099|0.352|0.938
91705473|NCT00419159|183305469|OTHER||Hazard Ratio (HR)|1.474||||0.145|TWO_SIDED|95.0|0.875|2.484|||Unadjusted Cox Model|||||2.484|0.875|0.145
91705474|NCT00419159|183305469|OTHER||Hazard Ratio, log|1.151||||0.583|TWO_SIDED|95.0|0.696|1.903|||Unadjusted Cox Model|||||1.903|0.696|0.583
91705475|NCT00419159|183305470|OTHER||Hazard Ratio (HR)|0.868||||0.588|TWO_SIDED|95.0|0.521|1.447|||Unadjusted Cox Model|||||1.447|0.521|0.588
91705476|NCT00419159|183305470|OTHER||Hazard Ratio (HR)|0.611||||0.148|TWO_SIDED|95.0|0.314|1.191|||Unadjusted Cox Model|||||1.191|0.314|0.148
91705477|NCT01017601|183305476|OTHER|||||||0.5|||||||Wilcoxon Rank Sum|||||||0.50
91705478|NCT01017601|183305477|OTHER|||||||0.96|||||||Wilcoxon Rank Sum|||||||0.96
91705479|NCT01017601|183305478|OTHER|||||||0.54|||||||Fisher Exact|||||||0.54
91705480|NCT01017601|183305479|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91705481|NCT04964986|183305481|SUPERIORITY|||||||0.041|||||||paired t-test|||||||0.041
91705482|NCT04964986|183305483|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 24||||<0.001
91705483|NCT04964986|183305483|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
91705484|NCT04964986|183305487|SUPERIORITY|||||||0.002|||||||paired t-test|||Week 24||||0.002
91705485|NCT04964986|183305487|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
91705486|NCT04964986|183305489|SUPERIORITY|||||||0.294|||||||paired t-test|||Fat absorption increase at Week 4||||0.294
91705487|NCT04964986|183305489|SUPERIORITY|||||||0.155|||||||paired t-test|||Fat absorption increase at Week 48||||0.155
91705488|NCT04964986|183305489|SUPERIORITY|||||||0.26|||||||paired t-test|||Carbohydrate absorption at Week 4||||0.260
91705489|NCT04964986|183305489|SUPERIORITY|||||||0.024|||||||paired t-test|||Carbohydrate absorption at Week 48||||0.024
91705490|NCT04964986|183305489|SUPERIORITY|||||||0.096|||||||paired t-test|||Protein absorption at Week 4||||0.096
91705491|NCT04964986|183305489|SUPERIORITY|||||||0.075|||||||paired t-test|||Protein absorption at Week 48||||0.075
91705492|NCT04964986|183305490|SUPERIORITY|||||||0.063|||||||paired t-test|||Week 4||||0.063
91705493|NCT04964986|183305490|SUPERIORITY|||||||0.112|||||||paired t-test|||Week 48||||0.112
91705494|NCT04964986|183305491|SUPERIORITY|||||||0.306|||||||paired t-test|||||||0.306
91705495|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|0.3346||||0.704|TWO_SIDED|95.0|-0.7887|0.8748|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 4||0.8748|-0.7887|0.704
91705496|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|-0.104||||0.488|TWO_SIDED|95.0|-2.7442|0.8896|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 48||0.8896|-2.7442|0.488
91705497|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|-0.219||||0.382|TWO_SIDED|95.0|-0.896|0.313|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 4||0.313|-0.896|0.382
91705498|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|-1.566||||0.059|TWO_SIDED|95.0|-5.279|-0.165|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 48||-0.165|-5.279|0.059
91696809|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.88|||||TWO_SIDED|95.0|0.665|1.166||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.166|0.665|
91696810|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.219|||||TWO_SIDED|95.0|2.43|4.264||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.264|2.430|
91696811|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.07|||||TWO_SIDED|95.0|0.808|1.417||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.417|0.808|
91696812|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.72|||||TWO_SIDED|95.0|0.544|0.954||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.954|0.544|
91696813|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.509|||||TWO_SIDED|95.0|1.891|3.33||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.330|1.891|
91696814|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.235|||||TWO_SIDED|95.0|0.178|0.31||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.310|0.178|
91696815|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.177|||||TWO_SIDED|95.0|0.134|0.234||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.234|0.134|
91696816|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.647|||||TWO_SIDED|95.0|0.489|0.856||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.856|0.489|
91705499|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|33.116||||0.004|TWO_SIDED|95.0|5.51|51.861|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 4||51.861|5.510|0.004
91758828|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.2149|TWO_SIDED|95.0|0.339|1.284||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.284|0.339|0.2149
91758829|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.9491|TWO_SIDED|95.0|0.466|2.26||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/RS2304061 Genotype: G/A||2.260|0.466|0.9491
91758830|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.8114|TWO_SIDED|95.0|0.447|1.881||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.881|0.447|0.8114
91728157|NCT03777176|183352118|SUPERIORITY|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate and number of hypoglycemic events during Weeks 2-4 as dependent variable.|Event rate ratio|0.85||||0.5028|TWO_SIDED|95.0|0.54|1.36|||Negative binomial regression|||The primary analysis was performed as a negative binominal regression analysis on the difference of the SMPG-detected hypoglycemia episode rate between treatment groups over the Weeks 2-4.||1.36|0.54|0.5028
91728158|NCT03777176|183352119|SUPERIORITY||Mean Difference (Net)|0.84||||0.6433|TWO_SIDED|95.0|-2.71|4.39||The P value should be interpreted with caution given the procedural issues (hypoglycemia at the beginning of the test, test meals not being the same, and some children only having 1 test) which affected the preplanned statistical evaluation.|ANCOVA|||||4.39|-2.71|0.6433
91728159|NCT03777176|183352120|SUPERIORITY||Mean Difference (Net)|0.15||||0.9653|TWO_SIDED|95.0|-6.48|6.78||There was 1 missing value at Baseline for the dasiglucagon + standard of care group.|ANCOVA|||||6.78|-6.48|0.9653
91728160|NCT03777176|183352121|SUPERIORITY||Event rate ratio|0.93||||0.8114|TWO_SIDED|95.0|0.49|1.74|||Negative binominal regression|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate.||||1.74|0.49|0.8114
91728161|NCT00378560|183352133|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|87.6|||||TWO_SIDED|95.0|59.2|97.6|||||Binomial probability conditional on the fixed number of events.|||97.6|59.2|
91728162|NCT00378560|183352134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91728163|NCT00378560|183352135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91728164|NCT00378560|183352136|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91728165|NCT00378560|183352137|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91728166|NCT02070380|183352138|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|47.6|||<|0.0001|TWO_SIDED|95.0|34.5|60.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment."||60.7|34.5|<0.0001
91728167|NCT02070380|183352138|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|7.3||||0.1295|TWO_SIDED|95.0|-2.0|16.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||16.5|-2.0|0.1295
91728168|NCT02070380|183352138|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|79.0|||<|0.0001|TWO_SIDED|95.0|67.1|91.0||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment"||91.0|67.1|<0.0001
91728169|NCT02070380|183352138|SUPERIORITY_OR_OTHER||Percentage MH better minus DM better|-2.1||||0.7503|TWO_SIDED|95.0|-15.0|10.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||10.7|-15.0|0.7503
91728170|NCT02070380|183352138|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|66.1|||<|0.0001|TWO_SIDED|95.0|52.8|79.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment"||79.5|52.8|<0.0001
91728171|NCT02070380|183352138|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|-2.1||||0.7297|TWO_SIDED|95.0|-13.8|9.6||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||9.6|-13.8|0.7297
91758831|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.577||||0.1379|TWO_SIDED|95.0|0.273|1.221||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.221|0.273|0.1379
91758832|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.859||||0.5341|TWO_SIDED|95.0|0.256|13.51||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.51|0.256|0.5341
91758833|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.8564|TWO_SIDED|95.0|0.431|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||2.014|0.431|0.8564
91758834|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.5766|TWO_SIDED|95.0|0.355|1.788||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||1.788|0.355|0.5766
91758835|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.2043|TWO_SIDED|95.0|0.14|1.557||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||1.557|0.140|0.2043
91490766|NCT01153347|182854323|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.92||0.68|TWO_SIDED|95.0|-2.2|1.43|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.43|-2.20|0.680
91728172|NCT02070380|183352139|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728173|NCT02070380|183352139|SUPERIORITY_OR_OTHER|||||||0.8238||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment."||||0.8238
91728174|NCT02070380|183352139|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728175|NCT02070380|183352139|SUPERIORITY_OR_OTHER|||||||0.4597||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.4597
91728176|NCT02070380|183352139|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728177|NCT02070380|183352139|SUPERIORITY_OR_OTHER|||||||0.8145||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.8145
91728178|NCT02070380|183352140|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0020
91490767|NCT01153347|182854324|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.737|TWO_SIDED|95.0|-2.23|1.58|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.58|-2.23|0.737
91490768|NCT01153347|182854324|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.547|TWO_SIDED|95.0|-2.52|1.33|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.33|-2.52|0.547
91728179|NCT02070380|183352140|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
91728180|NCT02070380|183352140|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0001
91728181|NCT02070380|183352140|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||1.0000
91728182|NCT02070380|183352140|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728183|NCT02070380|183352140|SUPERIORITY_OR_OTHER|||||||0.5811|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.5811
91728184|NCT02070380|183352141|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728185|NCT02070380|183352141|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
91728186|NCT02070380|183352141|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728187|NCT02070380|183352141|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
91490769|NCT01153347|182854324|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.99||0.953|TWO_SIDED|95.0|-1.89|2.01|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.01|-1.89|0.953
91728188|NCT02070380|183352141|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||0.0023
91728189|NCT02070380|183352141|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
91728190|NCT02070380|183352142|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728191|NCT02070380|183352142|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
91728192|NCT02070380|183352142|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728193|NCT02070380|183352142|SUPERIORITY_OR_OTHER|||||||0.7503|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.7503
91728194|NCT02070380|183352142|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
91728195|NCT02070380|183352142|SUPERIORITY_OR_OTHER|||||||0.5983|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.5983
91728196|NCT02070380|183352143|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||<0.0001
91728197|NCT02070380|183352143|SUPERIORITY_OR_OTHER|||||||0.6898|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.6898
91728198|NCT02070380|183352143|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect.||||||<0.0001
91728199|NCT02070380|183352143|SUPERIORITY_OR_OTHER|||||||0.1156|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.1156
91728200|NCT02070380|183352143|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91728201|NCT02070380|183352143|SUPERIORITY_OR_OTHER|||||||0.7726|||||||Mixed Models Analysis|||||||0.7726
91728202|NCT02070380|183352144|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0002
91728203|NCT02070380|183352144|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
91728204|NCT02070380|183352144|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
91728205|NCT02070380|183352144|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
91728206|NCT02070380|183352144|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
91728207|NCT02070380|183352144|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0003
91728208|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.139||||0.145|TWO_SIDED|95.0|0.956|1.357|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.357|0.956|0.145
91728209|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.11||||0.298|TWO_SIDED|95.0|0.912|1.35|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.35|0.912|0.298
91728210|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.178||||0.127|TWO_SIDED|95.0|0.955|1.452|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.452|0.955|0.127
91728211|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.117||||0.286|TWO_SIDED|95.0|0.911|1.37|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.37|0.911|0.286
91728212|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.179||||0.183|TWO_SIDED|95.0|0.925|1.504|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.504|0.925|0.183
91728213|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.2||||0.209|TWO_SIDED|95.0|0.903|1.595|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.595|0.903|0.209
91528281|NCT01288781|182931918|SUPERIORITY_OR_OTHER|||||||0.98||||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
91728214|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.144||||0.463|TWO_SIDED|95.0|0.799|1.638|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.638|0.799|0.463
91728215|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.331||||0.074|TWO_SIDED|95.0|0.972|1.822|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.822|0.972|0.074
91728216|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.169||||0.306|TWO_SIDED|95.0|0.867|1.577|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.577|0.867|0.306
91728217|NCT03850431|183352145|OTHER||Odds Ratio (OR)|1.15||||0.373|TWO_SIDED|95.0|0.845|1.565|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.565|0.845|0.373
91728218|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.923||||0.153|TWO_SIDED|95.0|0.826|1.03|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.03|0.826|0.153
91728219|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.911||||0.252|TWO_SIDED|95.0|0.777|1.068|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.068|0.777|0.252
91728220|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.941||||0.413|TWO_SIDED|95.0|0.815|1.088|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.088|0.815|0.413
91728221|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.946||||0.41|TWO_SIDED|95.0|0.83|1.079|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.079|0.83|0.41
91728222|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.887||||0.11|TWO_SIDED|95.0|0.766|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.766|0.11
91728223|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.833||||0.14|TWO_SIDED|95.0|0.654|1.062|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.062|0.654|0.14
91728224|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.882||||0.404|TWO_SIDED|95.0|0.657|1.184|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.184|0.657|0.404
91728225|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.743||||0.072|TWO_SIDED|95.0|0.538|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.538|0.072
91728226|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.778||||0.057|TWO_SIDED|95.0|0.6|1.008|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.008|0.6|0.057
91728227|NCT03850431|183352146|OTHER||Odds Ratio (OR)|0.932||||0.637|TWO_SIDED|95.0|0.697|1.247|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.247|0.697|0.637
91728228|NCT03760640|183352155|SUPERIORITY||LS Mean Difference|-0.86||||0.339|TWO_SIDED|90.0|-2.35|0.63|||Mixed Models Analysis|||||0.63|-2.35|0.339
91728229|NCT03760640|183352156|SUPERIORITY||LS Mean Difference|3.0||||0.011|TWO_SIDED|90.0|1.1|4.9|||Mixed Models Analysis|||||4.90|1.10|0.011
91728230|NCT03760640|183352157|SUPERIORITY||LS Mean Difference|0.56||||0.557|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||||2.14|-1.02|0.557
91728231|NCT03760640|183352158|SUPERIORITY||LS Mean Difference|-0.04||||0.548|TWO_SIDED|90.0|-0.15|0.07|||Mixed Models Analysis|||||0.07|-0.15|0.548
91728232|NCT03760640|183352160|SUPERIORITY||LS Mean Difference|0.49||||0.577|TWO_SIDED|90.0|-0.97|1.94|||Mixed Models Analysis|||||1.94|-0.97|0.577
91728233|NCT05463705|183352161|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.88|1.96||||||||1.96|0.88|
91728234|NCT05463705|183352161|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system),72,73 an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||||1.52|0.66|
91728235|NCT05463705|183352162|SUPERIORITY|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.83|1.61||||||||1.61|0.83|
91728236|NCT05463705|183352162|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.64|1.3||||||||1.30|0.64|
91728237|NCT05463705|183352163|SUPERIORITY||Difference in HbA1c %|0.18|||||TWO_SIDED|95.0|-0.07|0.43||||||||0.43|-0.07|
91728238|NCT05463705|183352163|SUPERIORITY||Difference in HbA1c %|0.06|||||TWO_SIDED|95.0|-0.22|0.34||||||||0.34|-0.22|
91728239|NCT03071965|183352201|SUPERIORITY||Median Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.0881||0.5455|TWO_SIDED|95.0|-0.226|0.12|||Mixed Models Analysis|||||0.120|-0.226|0.5455
91728240|NCT06399471|183352220|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.126||||||One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.|ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.126
91728241|NCT06399471|183352220|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.015|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Ten Meter Walking Test.||||0.015
91728242|NCT06399471|183352220|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.852|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.852
91490770|NCT01153347|182854325|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-2.069|0.864||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.864|-2.069|1.000
91490771|NCT01153347|182854325|SUPERIORITY_OR_OTHER||LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.755||1|TWO_SIDED|95.0|-2.004|0.96||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.960|-2.004|1.000
91490772|NCT01153347|182854325|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.761||1|TWO_SIDED|95.0|-1.095|1.896||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.896|-1.095|1.000
91490773|NCT01153347|182854326|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.953|TWO_SIDED|95.0|-0.56|0.59|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.59|-0.56|0.953
91728243|NCT06399471|183352221|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.003|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.003
91490774|NCT01153347|182854326|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.868|TWO_SIDED|95.0|-0.64|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.64|0.868
91705500|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|20.727||||0.337|TWO_SIDED|95.0|-27.758|55.828|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 48||55.828|-27.758|0.337
91705501|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|1.618||||0.724|TWO_SIDED|95.0|-11.87|14.931|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 4||14.931|-11.870|0.724
91705502|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|-9.19||||0.115|TWO_SIDED|95.0|-18.88|3.737|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 48||3.737|-18.880|0.115
91705503|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|12.297||||0.707|TWO_SIDED|95.0|-39.551|52.617|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 4||52.617|-39.551|0.707
91705504|NCT04964986|183305492|SUPERIORITY||Mean Difference (Final Values)|-91.487||||0.009|TWO_SIDED|95.0|-159.956|-20.068|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 48||-20.068|-159.956|0.009
91705505|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|0.281||||0.572|TWO_SIDED|95.0|-0.649|0.96|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 4||0.960|-0.649|0.572
91705506|NCT04964986|183305492|SUPERIORITY||Median Difference (Final Values)|-0.136||||0.981|TWO_SIDED|95.0|-1.06|1.073|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 48||1.073|-1.060|0.981
91705507|NCT04964986|183305493|SUPERIORITY|||||||0.066|||||||paired t-test|||Week 24||||0.066
91705508|NCT04964986|183305493|SUPERIORITY|||||||0.015|||||||paired t-test|||Week 52||||0.015
91705509|NCT00803205|183305500|SUPERIORITY|||||||0.3264|||||||ANOVA|||||||0.3264
91705510|NCT00803205|183305501|SUPERIORITY||Mean Difference (Final Values)|2.754|STANDARD_ERROR_OF_MEAN|1.78124||0.1235|TWO_SIDED|95.0|-0.756|6.264||The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.|Mixed Models Analysis|||Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.||6.2640|-0.7560|0.1235
91728244|NCT06399471|183352221|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.027|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Two Meter Walking Test.||||0.027
91728245|NCT06399471|183352221|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.425|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.425
91728246|NCT06399471|183352222|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.006|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the C-Leg 4.0.||||0.006
91728247|NCT06399471|183352222|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.236|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the Rheo.||||0.236
91728248|NCT06399471|183352222|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.118|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Rheo and the C-Leg 4.0.||||0.118
91728249|NCT06399471|183352223|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.687|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and the Rheo when used during Stance Time Asymmetry Index test.||||0.687
91490775|NCT01153347|182854326|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.5|0.66|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.66|-0.50|0.792
91728250|NCT06399471|183352224|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.082|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and Rheo when used during the Narrowing beam walking test.||||0.082
91728251|NCT06399471|183352225|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.943|||||||ANOVA|||An ANOVA was used to compare the reported falls when for when the Power Knee, C-Leg 4.0, and the Rheo were used.||||0.943
91728252|NCT06399471|183352226|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.535|||||||ANOVA|||An ANOVA was used to compare the Physiological cost index for when the Power Knee, the C-Leg 4.0, and the Rheo were used.||||0.535
91728253|NCT06399471|183352227|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.229|||||||ANOVA|||An ANOVA was used to compare the Stair Ascent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.229
91728254|NCT06399471|183352228|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.528|||||||ANOVA|||An ANOVA was used to compare the Stair Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.528
91728255|NCT06399471|183352229|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.144|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the C-Leg 4.0.||||0.144
91728256|NCT06399471|183352229|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.024|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the Rheo.||||0.024
91728257|NCT06399471|183352229|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.949|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Rheo and the C-Leg 4.0.||||0.949
91728258|NCT06399471|183352230|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.051|||||||ANOVA|||An ANOVA was used to compare the Ramp Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.051
91728259|NCT06399471|183352231|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.367|||||||ANOVA|||An ANOVA was used to compare the Steps per Day for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.367
91728260|NCT02662582|183352232|SUPERIORITY||LSMean difference|-12.0||||0.734|TWO_SIDED|90.0|-71.2|47.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Least square means (LSMeans), LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||47.2|-71.2|0.734
91728261|NCT02662582|183352233|SUPERIORITY||LSMean Difference|-0.0219||||0.438|TWO_SIDED|90.0|-0.0694|0.0256||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0256|-0.0694|0.438
91728262|NCT02662582|183352233|SUPERIORITY||LSMean Difference|-0.0325||||0.114|TWO_SIDED|90.0|-0.0663|0.0014||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0014|-0.0663|0.114
91728263|NCT02662582|183352234|SUPERIORITY||LSMean difference|0.75||||0.612|TWO_SIDED|90.0|-1.75|3.24||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.24|-1.75|0.612
91728264|NCT02662582|183352234|SUPERIORITY||LSMean difference|0.29||||0.789|TWO_SIDED|90.0|-1.55|2.14||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||2.14|-1.55|0.789
91490776|NCT01153347|182854327|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.915|TWO_SIDED|95.0|-0.54|0.48|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.48|-0.54|0.915
91490777|NCT01153347|182854327|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|95.0|-0.51|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.53|-0.51|0.972
91490778|NCT01153347|182854327|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.237|TWO_SIDED|95.0|-0.21|0.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.84|-0.21|0.237
91696817|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.215|||||TWO_SIDED|95.0|0.163|0.284||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.284|0.163|
91696818|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.145||||||95.0|0.109|0.191||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.191|0.109|
91696819|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.504|||||TWO_SIDED|95.0|0.381|0.668||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.668|0.381|
91696820|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.57|0.997||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.997|0.570|
91728265|NCT02662582|183352235|SUPERIORITY||LSMean difference|0.72||||0.225|TWO_SIDED|90.0|-0.26|1.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.70|-0.26|0.225
91728266|NCT02662582|183352235|SUPERIORITY||LSMean difference|0.92||||0.064||90.0|0.11|1.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.174|0.11|0.064
91728267|NCT02662582|183352236|SUPERIORITY||LSMean difference|0.052||||0.447|TWO_SIDED|90.0|-0.063|0.167||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.167|-0.063|0.447
91728268|NCT02662582|183352237|SUPERIORITY||LSMean difference|-0.8||||0.099|TWO_SIDED|90.0|-1.7|0.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0|-1.7|0.099
91728269|NCT02662582|183352237|SUPERIORITY||LSMean difference|-0.5||||0.255|TWO_SIDED|90.0|-1.3|0.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.2|-1.3|0.255
91728270|NCT02662582|183352237|SUPERIORITY||LSMean difference|-0.2||||0.651|TWO_SIDED|90.0|-1.1|0.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.6|-1.1|0.651
91490779|NCT01153347|182854328|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.213|TWO_SIDED|95.0|-0.87|0.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.19|-0.87|0.213
91728271|NCT02662582|183352237|SUPERIORITY||LSMean difference|-0.3||||0.591|TWO_SIDED|90.0|-1.0|0.5||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.5|-1.0|0.591
91728272|NCT02662582|183352238|SUPERIORITY||LSMean difference|0.0286||||0.04|TWO_SIDED|90.0|0.0061|0.0511||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0511|0.0061|0.040
91728273|NCT02662582|183352238|SUPERIORITY||LSMean differencce|0.0185||||0.155|TWO_SIDED|90.0|-0.0031|0.0401||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0401|-0.0031|0.155
91728274|NCT02662582|183352239|SUPERIORITY||LSMean difference|0.001||||0.972|TWO_SIDED|90.0|-0.0459|0.0479||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0479|-0.0459|0.972
91728275|NCT02662582|183352239|SUPERIORITY||LSMean difference|-0.0118||||0.578|TWO_SIDED|90.0|-0.0471|0.0236||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0236|-0.0471|0.578
91728276|NCT02662582|183352240|SUPERIORITY||LSMean difference|-0.65||||0.235|TWO_SIDED|90.0|-1.55|0.26||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.26|-1.55|0.235
91728277|NCT02662582|183352240|SUPERIORITY||LSMean differencce|-0.57||||0.215|TWO_SIDED|90.0|-1.33|0.19||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.19|-1.33|0.215
91728278|NCT02662582|183352241|SUPERIORITY||LSMean difference|0.7||||0.28|TWO_SIDED|90.0|-0.38|1.77||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.77|-0.38|0.280
91728279|NCT02662582|183352241|SUPERIORITY||LSMean difference|0.46||||0.424|TWO_SIDED|90.0|-0.49|1.4||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.40|-0.49|0.424
91728280|NCT02662582|183352242|SUPERIORITY||LSMean difference|0.039||||0.187|TWO_SIDED|90.0|-0.0099|0.0879||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0879|-0.0099|0.187
91728281|NCT02662582|183352242|SUPERIORITY||LSMean difference|0.0488||||0.213|TWO_SIDED|90.0|-0.0163|0.114||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.1140|-0.0163|0.213
91728282|NCT02662582|183352243|SUPERIORITY||LSMean difference|-0.4||||0.64||90.0|-2.1|1.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.2|-2.1|0.640
91728283|NCT02662582|183352243|SUPERIORITY||LSMean difference|-0.7||||0.487|TWO_SIDED|90.0|-2.5|1.1||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.1|-2.5|0.487
91728284|NCT02662582|183352244|SUPERIORITY||LSMean difference|0.095||||0.1|TWO_SIDED|90.0|0.0|0.189||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.189|0.000|0.100
91728285|NCT02662582|183352244|SUPERIORITY||LSMean difference|0.133||||0.008|TWO_SIDED|90.0|0.053|0.213||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.213|0.053|0.008
91728286|NCT02662582|183352245|SUPERIORITY||LSMean difference|0.051||||0.408|TWO_SIDED|90.0|-0.052|0.154||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.154|-0.052|0.408
91728287|NCT02662582|183352245|SUPERIORITY||LSMean difference|0.094||||0.058|TWO_SIDED|90.0|0.013|0.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.174|0.013|0.058
91728288|NCT02662582|183352246|SUPERIORITY||LSMean difference|1.44||||0.648|TWO_SIDED|90.0|-3.85|6.73||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||6.73|-3.85|0.648
91728289|NCT02662582|183352246|SUPERIORITY||LSMean difference|0.85||||0.775|TWO_SIDED|90.0|-4.12|5.82||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.82|-4.12|0.775
91728290|NCT02662582|183352247|SUPERIORITY||LSMean difference|1.1||||0.544|TWO_SIDED|90.0|-1.9|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-1.9|0.544
91728291|NCT02662582|183352247|SUPERIORITY||LSMean difference|2.1||||0.216|TWO_SIDED|90.0|-0.7|5.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.0|-0.7|0.216
91728292|NCT02662582|183352248|SUPERIORITY||LSMean difference|-7.4||||0.171|TWO_SIDED|90.0|-16.5|1.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.6|-16.5|0.171
91728293|NCT02662582|183352248|SUPERIORITY||LSMean difference|0.2||||0.976|TWO_SIDED|90.0|-10.3|10.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||10.7|-10.3|0.976
91758836|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.1626|TWO_SIDED|95.0|0.214|1.317||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||1.317|0.214|0.1626
91758837|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.968|TWO_SIDED|95.0|0.484|2.006||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.006|0.484|0.9680
91758838|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.3587|TWO_SIDED|95.0|0.171|1.92||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||1.920|0.171|0.3587
91758839|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.742||||0.4635|TWO_SIDED|95.0|0.331|1.662||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||1.662|0.331|0.4635
91758840|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.9834|TWO_SIDED|95.0|0.476|2.069||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.069|0.476|0.9834
91490780|NCT01153347|182854328|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.343|TWO_SIDED|95.0|-0.8|0.28|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.28|-0.80|0.343
91490781|NCT01153347|182854328|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.971|TWO_SIDED|95.0|-0.55|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.53|-0.55|0.971
91490782|NCT01153347|182854329|SUPERIORITY_OR_OTHER||LS mean|2.1|STANDARD_ERROR_OF_MEAN|1.694||0.215|TWO_SIDED|95.0|-1.224|5.431|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||5.431|-1.224|0.215
91696821|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.756|||||TWO_SIDED|95.0|2.083|3.647||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.647|2.083|
91696822|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.916|||||TWO_SIDED|95.0|0.694|1.211||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.211|0.694|
91696823|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.616|||||TWO_SIDED|95.0|0.466|1.815||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.815|0.466|
91696824|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.149|||||TWO_SIDED|95.0|1.624|2.843||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.843|1.624|
91696825|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.656|||||TWO_SIDED|95.0|2.764|4.836||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.836|2.764|
91696826|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.216|||||TWO_SIDED|95.0|0.92|1.606||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.606|0.920|
91696827|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.818|||||TWO_SIDED|95.0|0.619|1.081||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.081|0.619|
91728294|NCT02662582|183352249|SUPERIORITY||LSMean difference|-0.6||||0.844|TWO_SIDED|90.0|-6.1|4.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.9|-6.1|0.844
91696828|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.85|||||TWO_SIDED|95.0|2.152|3.773||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.773|2.152|
91728295|NCT02662582|183352249|SUPERIORITY||LSMean difference|-0.9||||0.751|TWO_SIDED|90.0|-5.8|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-5.8|0.751
91728296|NCT02662582|183352250|SUPERIORITY||LSMean difference|0.2||||0.59|TWO_SIDED|90.0|-0.5|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.5|0.590
91728297|NCT02662582|183352250|SUPERIORITY||LSMean difference|0.3||||0.399|TWO_SIDED|90.0|-0.3|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.3|0.399
91728298|NCT02662582|183352251|SUPERIORITY||LSMean difference|-0.09||||0.151|TWO_SIDED|90.0|-0.2|0.01||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.01|-0.20|0.151
91728299|NCT02662582|183352252|SUPERIORITY||LSMean difference|-0.007||||0.857|TWO_SIDED|90.0|-0.07|0.056||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.056|-0.070|0.857
91728300|NCT02662582|183352253|SUPERIORITY||LSMean difference|1.56||||0.11|TWO_SIDED|90.0|-0.05|3.17||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.17|-0.05|0.110
91728301|NCT02662582|183352254|SUPERIORITY||LSMean difference|2.07||||0.766|TWO_SIDED|90.0|-9.57|13.71||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.71|-9.57|0.766
91728302|NCT02662582|183352254|SUPERIORITY||LSMean difference|2.94||||0.642|TWO_SIDED|90.0|-7.66|13.54||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.54|-7.66|0.642
91728303|NCT01691482|183352270|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
91728304|NCT01691482|183352270|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
91728305|NCT01691482|183352270|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
91728306|NCT01691482|183352270|SUPERIORITY_OR_OTHER||Slope|0.062|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
91728307|NCT01691482|183352274|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
91728308|NCT01691482|183352274|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
91728309|NCT01691482|183352274|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
91728310|NCT01691482|183352274|SUPERIORITY_OR_OTHER||Adjusted Mean|0.062||||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
91758841|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||1.725|0.072|0.1764
91490783|NCT01153347|182854329|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|1.702||0.673|TWO_SIDED|95.0|-2.624|4.062|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.062|-2.624|0.673
91490784|NCT01153347|182854329|SUPERIORITY_OR_OTHER||LS mean|-1.88|STANDARD_ERROR_OF_MEAN|1.716||0.275|TWO_SIDED|95.0|-5.248|1.494|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.494|-5.248|0.275
91696829|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.332|||||TWO_SIDED|95.0|0.251|0.44||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.440|0.251|
91696830|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.224|||||TWO_SIDED|95.0|0.169|0.296||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.296|0.169|
91696831|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.78|||||TWO_SIDED|95.0|0.588|1.003||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.003|0.588|
91696832|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.673|||||TWO_SIDED|95.0|0.509|0.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.889|0.509|
91696833|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.345|||||TWO_SIDED|95.0|1.772|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.772|
91490785|NCT01153347|182854330|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.412|TWO_SIDED|95.0|-0.28|0.11|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.11|-0.28|0.412
91490786|NCT01153347|182854330|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.928|TWO_SIDED|95.0|-0.19|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.19|0.928
91490787|NCT01153347|182854330|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||-0.02|-0.42|0.033
91490788|NCT01153347|182854331|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.353|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.28|-0.10|0.353
91490789|NCT01153347|182854331|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.721|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.23|-0.16|0.721
91490790|NCT01153347|182854331|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.666|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.15|-0.24|0.666
91490791|NCT01153347|182854332|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0201||0.747|TWO_SIDED|95.0|-0.0459|0.0329||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0329|-0.0459|0.747
91490792|NCT01153347|182854332|SUPERIORITY_OR_OTHER||LS mean|-0.013|STANDARD_ERROR_OF_MEAN|0.0203||0.524|TWO_SIDED|95.0|-0.0529|0.027||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0270|-0.0529|0.524
91490793|NCT01153347|182854332|SUPERIORITY_OR_OTHER||LS mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0206||0.502|TWO_SIDED|95.0|-0.0543|0.0267||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0267|-0.0543|0.502
91696834|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.485|||||TWO_SIDED|95.0|2.633|4.614||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.614|2.633|
91696835|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.624|||||TWO_SIDED|95.0|1.817|3.789||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.789|1.817|
91696836|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.096|||||TWO_SIDED|95.0|0.76|1.58||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.580|0.760|
91696837|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.888|||||TWO_SIDED|95.0|0.615|1.282||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.282|0.615|
91696838|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.12|||||TWO_SIDED|95.0|1.473|3.052||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.052|1.473|
91728311|NCT01691482|183352275|SUPERIORITY_OR_OTHER||Adjusted Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.058|0.076|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.076|0.058|
91758842|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.2018|TWO_SIDED|95.0|0.422|1.209||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||1.209|0.422|0.2018
91728312|NCT01691482|183352275|SUPERIORITY_OR_OTHER||Adjusted Mean|0.07|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.061|0.079|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.079|0.061|
91728313|NCT01691482|183352275|SUPERIORITY_OR_OTHER||Adjusted Mean|0.069|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.06|0.078|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.078|0.060|
91728314|NCT01691482|183352275|SUPERIORITY_OR_OTHER||Adjusted Mean|0.064|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.055|0.073|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.073|0.055|
91728315|NCT01691482|183352276|SUPERIORITY_OR_OTHER||Adjusted Mean|0.228|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.2|0.255|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.255|0.200|
91728316|NCT01691482|183352276|SUPERIORITY_OR_OTHER||Adjusted Mean|0.231|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.203|0.258|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.258|0.203|
91728317|NCT01691482|183352276|SUPERIORITY_OR_OTHER||Adjusted Mean|0.232|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.204|0.259|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.259|0.204|
91728318|NCT01691482|183352276|SUPERIORITY_OR_OTHER||Adjusted Mean|0.217|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.19|0.245|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.245|0.190|
91728319|NCT01953354|183352277|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
91728320|NCT01953354|183352278|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
91490794|NCT01153347|182854332|SUPERIORITY_OR_OTHER||LS mean|1.9|STANDARD_ERROR_OF_MEAN|2.06||0.345|TWO_SIDED|95.0|-2.1|6.0||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.00|-2.10|0.345
91728321|NCT01953354|183352279|SUPERIORITY_OR_OTHER|||||||0.242||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.242
91728322|NCT01953354|183352280|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
91728323|NCT01953354|183352283|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
91728324|NCT01953354|183352284|SUPERIORITY_OR_OTHER|||||||0.633||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.633
91728325|NCT00806026|183352290|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-4.5|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.9|-3.2||This analysis was step 1 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region \[United states (US) or European union (EU)\], treatment, week and treatment by week interaction as fixed effects.||-3.20|-5.90|<0.0001
91728326|NCT00806026|183352290|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3603|TWO_SIDED|95.0|-2.0|0.7||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.7|-2.0|0.3603
91728327|NCT00806026|183352290|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.5|-1.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-1.9|-4.5|<0.0001
91728328|NCT00806026|183352291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||This analysis was step 2 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pregabalin 300 mg versus placebo: Cochran-Mantel-Haenszel (CMH) test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||<0.0001
91728329|NCT00806026|183352291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4393|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.25 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.4393
91758843|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.4592|TWO_SIDED|95.0|0.354|9.673||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||9.673|0.354|0.4592
91490795|NCT01153347|182854332|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|2.09||0.486|TWO_SIDED|95.0|-2.65|5.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||5.56|-2.65|0.486
91728330|NCT00806026|183352291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.5 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.0022
91728331|NCT00806026|183352292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0826|TWO_SIDED|||||This analysis was step 6 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.25 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0826
91728332|NCT00806026|183352292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||This analysis was step 3 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.5 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0012
91728333|NCT00806026|183352294|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.25|STANDARD_ERROR_OF_MEAN|4.332|<|0.0001|TWO_SIDED|95.0|-25.76|-8.74||This analysis was step 7 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-8.74|-25.76|<0.0001
91728334|NCT00806026|183352294|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|4.408||0.8075|TWO_SIDED|95.0|-9.73|7.58||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||7.58|-9.73|0.8075
91728335|NCT00806026|183352294|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.57|STANDARD_ERROR_OF_MEAN|4.318||0.2906|TWO_SIDED|95.0|-13.05|3.91||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||3.91|-13.05|0.2906
91728336|NCT00806026|183352300|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.93||0.7073|TWO_SIDED|95.0|-9.3|6.3||This analysis was step 8 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||6.30|-9.30|0.7073
91728337|NCT00806026|183352300|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|3.78||0.5299|TWO_SIDED|95.0|-5.1|9.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||9.9|-5.1|0.5299
91728338|NCT00806026|183352300|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|3.69||0.0354|TWO_SIDED|95.0|-15.2|-0.5||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.5|-15.2|0.0354
91728339|NCT00806026|183352302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|95.0|-1.55|-0.45||This analysis was step 9 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.45|-1.55|0.0004
91758844|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.1593|TWO_SIDED|95.0|0.373|1.184||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.184|0.373|0.1593
91758845|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.327||||0.5897|TWO_SIDED|95.0|0.469|3.755||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||3.755|0.469|0.5897
91758846|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.309|0.488|0.3681
91758847|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.3235|TWO_SIDED|95.0|0.423|1.336||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.336|0.423|0.3235
91490796|NCT01153347|182854332|SUPERIORITY_OR_OTHER||LS mean|-1.2|STANDARD_ERROR_OF_MEAN|2.12||0.564|TWO_SIDED|95.0|-5.39|2.94||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.94|-5.39|0.564
91490797|NCT01153347|182854333|SUPERIORITY_OR_OTHER||LS mean|-1.4|STANDARD_ERROR_OF_MEAN|1.55||0.35|TWO_SIDED|95.0|-4.48|1.59|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.59|-4.48|0.350
91490798|NCT01153347|182854333|SUPERIORITY_OR_OTHER||LS mean|-1.3|STANDARD_ERROR_OF_MEAN|1.56||0.393|TWO_SIDED|95.0|-4.41|1.73|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-4.41|0.393
91696839|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.876|||||TWO_SIDED|95.0|0.61|1.26||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.260|0.610|
91696840|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric mean ratio at day 202|0.898|||||TWO_SIDED|95.0|0.622|1.298||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.298|0.622|
91696841|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.451|||||TWO_SIDED|95.0|1.0|2.105||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.105|1.000|
91696842|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.418|||||TWO_SIDED|95.0|0.289|0.603||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.603|0.289|
91696843|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.338|||||TWO_SIDED|95.0|0.235|0.487||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.487|0.235|
91696844|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.808|||||TWO_SIDED|95.0|0.561|1.165||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.165|0.561|
91696845|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.334|||||TWO_SIDED|95.0|0.233|0.479||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.479|0.233|
91728340|NCT00806026|183352302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.282||0.1242|TWO_SIDED|95.0|-0.99|0.12||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.12|-0.99|0.1242
91728341|NCT00806026|183352302|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.287||0.0553|TWO_SIDED|95.0|-1.12|0.01||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.01|-1.12|0.0553
91728342|NCT03733483|183352319|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on P1NP levels. Change in P1NP in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.53|||||||Mixed Models Analysis|||||||0.53
91728343|NCT03733483|183352320|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on CTX levels. Change in CTX in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.1|||||||Mixed Models Analysis|||||||0.10
91728344|NCT00147537|183352328|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||binomial test|||A one-sided p-value for H0: objective response rate \<=0.28 using exact binomial test at level 0.05.||||=0.027
91728345|NCT00147537|183352329|SUPERIORITY_OR_OTHER||||||=|0.121|TWO_SIDED||||||binomial test|||A One-sided p-value for H0: objective response rate \<=0.30 using exact binomial test at level 0.05.||||=0.121
91728346|NCT01927861|183352359|OTHER||Treatment difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.38|0.88|||ANCOVA|||The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline height SDS as a covariate.||0.88|0.38|< 0.0001
91728347|NCT00987935|183352427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.357|||||TWO_SIDED|95.0|0.802|2.296|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.296|0.802|
91728348|NCT00987935|183352428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|||||TWO_SIDED|95.0|0.73|2.014|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.014|0.730|
91728349|NCT00987935|183352432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|||||TWO_SIDED|95.0|0.728|1.932|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.932|0.728|
91728350|NCT00987935|183352433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.593|1.489|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.489|0.593|
91728351|NCT00452530|183352441|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.0003||||||1-sided P-value|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||||0.0003
91728352|NCT00452530|183352441|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.04||||||95.0|-2.03|-0.05|||Inverse variance method|||Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||-0.05|-2.03|
91728353|NCT00452530|183352442|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.33||||0.3014|TWO_SIDED|95.0|-0.95|0.29|||Mantel Haenszel||Apixaban-enoxaparin|Major bleeding||0.29|-0.95|0.3014
91728354|NCT00452530|183352442|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.91||||0.1668|TWO_SIDED|95.0|-2.2|0.38|||Mantel Haenszel||Apixaban-enoxaparin|CRNM||0.38|-2.20|0.1668
91728355|NCT00452530|183352442|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.24||||0.0881|TWO_SIDED|95.0|-2.66|0.18|||Mantel Haenszel||Apixaban-enoxaparin|Major or CRNM||0.18|-2.66|0.0881
91728356|NCT00452530|183352442|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.39||||0.1412|TWO_SIDED|95.0|-3.29|0.51|||Mantel Haenszel||Apixaban-enoxaparin|Any bleeding||0.51|-3.29|0.1412
91728357|NCT00452530|183352443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.74||P-value was statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||0.74|0.51|<0.0001
91728358|NCT00452530|183352443|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.27|||<|0.0001||95.0|-12.74|-5.79||P-value is statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||-5.79|-12.74|<0.0001
91728359|NCT02222181|183352448|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 1 sided|||||||0.23
91728360|NCT02222181|183352449|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91728361|NCT02222181|183352450|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||||||0.03
91728362|NCT02222181|183352451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91728363|NCT02222181|183352452|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 1 sided|||||||0.025
91728364|NCT02222181|183352453|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91728365|NCT02222181|183352454|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91490799|NCT01153347|182854333|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|1.58||0.745|TWO_SIDED|95.0|-2.59|3.62|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.62|-2.59|0.745
91490800|NCT04678661|182854347|SUPERIORITY|||||||0.207||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Regression, Linear|Model adjusted for covariates of age, race, baseline BMI, and baseline hemoglobin A1c.||||||.207
91490801|NCT04678661|182854348|OTHER|||||||0.011|||||||t-test, 2 sided|||Independent t-test||||.011
91696846|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.342|||||TWO_SIDED|95.0|0.237|0.494||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.494|0.237|
91696847|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.553|||||TWO_SIDED|95.0|0.382|0.801||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.801|0.382|
91696848|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.811|||||TWO_SIDED|95.0|0.562|1.169||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.169|0.562|
91696849|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.935|||||TWO_SIDED|95.0|1.347|2.78||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.780|1.347|
91696850|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.8|||||TWO_SIDED|95.0|0.558|1.147||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.147|0.558|
91696851|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.82|||||TWO_SIDED|95.0|0.568|1.184||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.184|0.568|
91728366|NCT02191397|183352455|NON_INFERIORITY|A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram.|Mean Difference (Final Values)|0.8||||0.139|TWO_SIDED|95.0|-0.27|1.94||Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.94|-0.27|0.139
91728367|NCT02191397|183352456|OTHER||Odds Ratio (OR)|0.85||||0.479|TWO_SIDED|95.0|0.55|1.33||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables.|GEE model|||||1.33|0.55|0.479
91728368|NCT02191397|183352457|OTHER||Odds Ratio (OR)|0.73||||0.129|TWO_SIDED|95.0|0.48|1.1||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.10|0.48|0.129
91490802|NCT04678661|182854349|OTHER|||||||0.024|||||||t-test, 2 sided|||||||.024
91728369|NCT02191397|183352458|OTHER||Odds Ratio (OR)|0.83||||0.354|TWO_SIDED|95.0|0.55|1.24||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.24|0.55|0.354
91728370|NCT02191397|183352459|OTHER||Odds Ratio (OR)|0.85||||0.489|TWO_SIDED|95.0|0.54|1.34||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.34|0.54|0.489
91728371|NCT02191397|183352460|OTHER||Mean Difference (Final Values)|0.2||||0.627|TWO_SIDED|95.0|-0.7|1.16||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.16|-0.70|0.627
91728372|NCT02191397|183352460|OTHER||Mean Difference (Final Values)|1.4||||0.037|TWO_SIDED|95.0|0.08|2.66||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.66|0.08|0.037
91728373|NCT02191397|183352460|OTHER||Mean Difference (Final Values)|1.2||||0.143|TWO_SIDED|95.0|-0.4|2.78||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.78|-0.40|0.143
91696852|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.324|||||TWO_SIDED|95.0|0.915|1.917||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.917|0.915|
91728374|NCT02191397|183352460|OTHER||Mean Difference (Final Values)|0.8||||0.33|TWO_SIDED|95.0|-0.81|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.81|0.330
91728375|NCT02191397|183352460|OTHER||Mean Difference (Final Values)|0.9||||0.278|TWO_SIDED|95.0|-0.69|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.69|0.278
91728376|NCT02191397|183352461|OTHER||Mean Difference (Final Values)|0.0||||0.579|TWO_SIDED|95.0|-0.09|0.16||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.16|-0.09|0.579
91728377|NCT02191397|183352461|OTHER||Mean Difference (Final Values)|0.1||||0.163|TWO_SIDED|95.0|-0.04|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.04|0.163
91728378|NCT02191397|183352461|OTHER||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.34||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.34|0.00|0.050
91728379|NCT02191397|183352461|OTHER||Mean Difference (Final Values)|0.1||||0.337|TWO_SIDED|95.0|-0.09|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.09|0.337
91728380|NCT02191397|183352461|OTHER||Mean Difference (Final Values)|0.0||||0.714|TWO_SIDED|95.0|-0.14|0.2||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.20|-0.14|0.714
91758848|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.7463|TWO_SIDED|95.0|0.303|2.355||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.355|0.303|0.7463
91758849|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.4179|TWO_SIDED|95.0|0.33|1.593||2-sided unstratified log-rank test|Log Rank|||Locus: rs740751 Genotype: C/C||1.593|0.330|0.4179
91758850|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9423|TWO_SIDED|95.0|0.462|2.05||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.050|0.462|0.9423
91490803|NCT04678661|182854350|OTHER|||||||0.579|||||||t-test, 2 sided|||||||.579
91490804|NCT04678661|182854351|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
91490805|NCT04678661|182854352|OTHER|||||||0.269|||||||t-test, 2 sided|||||||.269
91490806|NCT04678661|182854355|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
91490807|NCT04678661|182854356|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
91728381|NCT02191397|183352462|OTHER||Mean Difference (Final Values)|-0.2||||0.358|TWO_SIDED|95.0|-0.5|0.18||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.18|-0.50|0.358
91728382|NCT02191397|183352462|OTHER||Mean Difference (Final Values)|0.4||||0.081|TWO_SIDED|95.0|-0.04|0.75||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.75|-0.04|0.081
91728383|NCT02191397|183352462|OTHER||Mean Difference (Final Values)|0.5||||0.062|TWO_SIDED|95.0|-0.02|0.99||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.99|-0.02|0.062
91728384|NCT02191397|183352462|OTHER||Mean Difference (Final Values)|0.4||||0.118|TWO_SIDED|95.0|-0.1|0.85||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.85|-0.10|0.118
91728385|NCT02191397|183352462|OTHER||Mean Difference (Final Values)|0.3||||0.252|TWO_SIDED|95.0|-0.19|0.71||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.71|-0.19|0.252
91728386|NCT02191397|183352463|OTHER||Mean Difference (Final Values)|0.1||||0.573|TWO_SIDED|95.0|-0.2|0.35||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.20|0.573
91728387|NCT02191397|183352463|OTHER||Mean Difference (Final Values)|0.2||||0.209|TWO_SIDED|95.0|-0.13|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.13|0.209
91728388|NCT02191397|183352463|OTHER||Mean Difference (Final Values)|0.2||||0.427|TWO_SIDED|95.0|-0.25|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.25|0.427
91728389|NCT02191397|183352463|OTHER||Mean Difference (Final Values)|0.0||||0.851|TWO_SIDED|95.0|-0.4|0.48||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.48|-0.40|0.851
91728390|NCT02191397|183352463|OTHER||Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|95.0|-0.25|0.66||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|-0.25|0.370
91728391|NCT02191397|183352464|OTHER||Mean Difference (Final Values)|0.1||||0.438|TWO_SIDED|95.0|-0.16|0.37||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.37|-0.16|0.438
91728392|NCT02191397|183352464|OTHER||Mean Difference (Final Values)|0.4||||0.014|TWO_SIDED|95.0|0.07|0.66||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|0.07|0.014
91728393|NCT02191397|183352464|OTHER||Mean Difference (Final Values)|0.2||||0.207|TWO_SIDED|95.0|-0.11|0.5||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.50|-0.11|0.207
91728394|NCT02191397|183352464|OTHER||Mean Difference (Final Values)|0.2||||0.137|TWO_SIDED|95.0|-0.07|0.54||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.54|-0.07|0.137
91490808|NCT04678661|182854357|OTHER|||||||0.647|||||||t-test, 2 sided|||||||.647
91490809|NCT01773733|182854492|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91490810|NCT03416946|182854551|SUPERIORITY|||||||0.79||||||Post-op HKA angle|t-test, 2 sided|||||||0.790
91490811|NCT01081678|182854566|OTHER|||||||0.1983|||||||F-test|The p-value is based on F-test of multi-linear contrasts at Week 6 through Week 20.||The primary analysis was based on a test for linear trend in dose response at weeks 6, 12, 16, and 20. To account for multiple comparisons over time points, the primary analysis used a size α = 0.05 F-test with 4 degrees of freedom for the contrasts at Weeks 6, 12, 16, and 20.||||0.1983
91490812|NCT01619423|182854578|SUPERIORITY||Odds Ratio (OR)|0.78||||0.31|ONE_SIDED|10.0||1.5|||Cochran-Mantel-Haenszel|||||1.5||0.31
91696853|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.388|||||TWO_SIDED|95.0|1.658|3.438||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.438|1.658|
91696854|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.987|||||TWO_SIDED|95.0|0.688|1.416||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.416|0.688|
91696855|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.012|||||TWO_SIDED|95.0|0.701|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.701|
91696856|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.634|||||TWO_SIDED|95.0|1.128|2.366||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.366|1.128|
91696857|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.413|||||TWO_SIDED|95.0|0.288|0.592||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.592|0.288|
91696858|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.424|||||TWO_SIDED|95.0|0.294|0.61||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.610|0.294|
91696859|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.684|||||TWO_SIDED|95.0|0.473|0.99||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.990|0.473|
91696860|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.025|||||TWO_SIDED|95.0|0.714|1.473||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.473|0.714|
91696861|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.656|||||TWO_SIDED|95.0|1.15|2.385||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.385|1.150|
91696862|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.615|||||TWO_SIDED|95.0|1.115|2.339||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.339|1.115|
91728395|NCT02191397|183352464|OTHER||Mean Difference (Final Values)|0.2||||0.299|TWO_SIDED|95.0|-0.14|0.46||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.46|-0.14|0.299
91728396|NCT02191397|183352465|OTHER||Mean Difference (Final Values)|0.0||||0.804|TWO_SIDED|95.0|-0.1|0.13||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.13|-0.10|0.804
91728397|NCT02191397|183352465|OTHER||Mean Difference (Final Values)|0.1||||0.079|TWO_SIDED|95.0|-0.02|0.28||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.28|-0.02|0.079
91728398|NCT02191397|183352465|OTHER||Mean Difference (Final Values)|0.2||||0.036|TWO_SIDED|95.0|0.01|0.38||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.38|0.01|0.036
91728399|NCT02191397|183352465|OTHER||Mean Difference (Final Values)|0.1||||0.248|TWO_SIDED|95.0|-0.08|0.31||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.31|-0.08|0.248
91728400|NCT02191397|183352465|OTHER||Mean Difference (Final Values)|0.2||||0.11|TWO_SIDED|95.0|-0.04|0.35||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.04|0.110
91728401|NCT02191397|183352466|OTHER||Odds Ratio, log|0.78||||0.545|TWO_SIDED|95.0|0.35|1.75||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.75|0.35|0.545
91728402|NCT02191397|183352466|OTHER||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.58|1.54||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.54|0.58|0.822
91728403|NCT02191397|183352466|OTHER||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|95.0|0.38|0.86||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.86|0.38|0.007
91728404|NCT02191397|183352466|OTHER||Odds Ratio (OR)|0.83||||0.417|TWO_SIDED|95.0|0.54|1.29||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.29|0.54|0.417
91490813|NCT01619423|182854578|SUPERIORITY||Odds Ratio (OR)|0.55||||0.15|ONE_SIDED|10.0||1.16|||Cochran-Mantel-Haenszel|||||1.16||0.15
91490814|NCT01619423|182854578|SUPERIORITY||Odds Ratio (OR)|0.62||||0.16|ONE_SIDED|10.0||1.14|||Cochran-Mantel-Haenszel|||||1.14||0.16
91490815|NCT03733470|182854611|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91728405|NCT02191397|183352466|OTHER||Odds Ratio (OR)|0.83||||0.485|TWO_SIDED|95.0|0.49|1.4||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.40|0.49|0.485
91728406|NCT00728182|183352483|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regression.||Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.||||0.445
91728407|NCT00728182|183352484|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.53||||0.018|TWO_SIDED|95.0|0.38|0.74|||Generalized linear model|With log link and negative bnomial distribution.||Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.||0.74|0.38|0.018
91728408|NCT00728182|183352485|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.59||||0.048|TWO_SIDED|95.0|0.42|0.83|||Generalized linear model|With log link and negative binomial distribution.||Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.||0.83|0.42|0.048
91728409|NCT00728182|183352486|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regresion.||Comparison of the summed volume of new ischemic lesions on DWI.||||0.306
91728410|NCT00728182|183352487|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.43|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.||1.1|0.9|0.43
91728411|NCT00728182|183352488|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.||1.1|0.9|1.00
91728412|NCT00728182|183352489|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|||||||0.023
91728413|NCT00728182|183352490|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.027|TWO_SIDED|95.0|0.17|0.73|||Adjusted Incidence Rate Ratio|||||0.73|0.17|0.027
91728414|NCT00728182|183352491|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.046|TWO_SIDED|95.0|0.17|0.75|||Generalized linear model|||||0.75|0.17|0.046
91728415|NCT00728182|183352492|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
91728416|NCT00728182|183352493|SUPERIORITY_OR_OTHER||Relative Risk|1.5||||0.02|TWO_SIDED|95.0|1.1|2.0|||Chi-squared|||||2.0|1.1|0.02
91728417|NCT00728182|183352494|SUPERIORITY_OR_OTHER||Relative Risk|1.3||||0.18|TWO_SIDED|95.0|0.95|1.7|||Chi-squared|||||1.7|0.95|0.18
91728418|NCT03856177|183352495|OTHER|||||||0.071|||||||t-test, 2 sided|||||||.071
91728419|NCT01898091|183352496|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxin rank sum test|||Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.||||0.84
91728420|NCT01933425|183352497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.05|TWO_SIDED|95.0|0.07|0.59|||t-test, 2 sided|||||0.59|0.07|<0.05
91728421|NCT01933425|183352498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED|95.0|0.06|0.54|||t-test, 2 sided|||||0.54|0.06|<0.05
91728422|NCT03888482|183352500|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.01|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Clariti|||0.01||
91728423|NCT04679818|183352514|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.895|TWO_SIDED|99.0|-1.43|1.58|||Mixed Models Analysis|||||1.58|-1.43|0.895
91728424|NCT04679818|183352515|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.228|TWO_SIDED|99.0|-2.66|0.99|||Mixed Models Analysis|||||0.99|-2.66|0.228
91728425|NCT04679818|183352516|SUPERIORITY||Risk Ratio (RR)|0.81||||0.565|TWO_SIDED|95.0|0.4|1.65|||generalized linear mixed effects model|||||1.65|0.40|0.565
91728426|NCT04679818|183352517|SUPERIORITY||Risk Ratio (RR)|1.48||||0.379|TWO_SIDED|95.0|0.62|3.54|||Generalized linear mixed effects model|||||3.54|0.62|0.379
91728427|NCT04679818|183352518|SUPERIORITY||Median Difference (Final Values)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Wilcoxon (Mann-Whitney)|||||0.97|0.30|0.039
91728428|NCT04679818|183352519|NON_INFERIORITY|We tested noninferiority of NOL to routine care on the Ramsey score using an a priori-defined noninferiority delta of 1.2 for the proportional odds ratio; NOL would be deemed noninferior if the upper confidence limit for the odds ratio was \<1.2.|Odds Ratio (OR)|0.8||||0.169|TWO_SIDED|95.0|0.35|1.82|||proportional odds model|||||1.82|0.35|0.169
91728429|NCT04679818|183352520|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.967|TWO_SIDED|95.0|0.63|1.63|||Cox proportional hazards regression|||||1.63|0.63|0.967
91728430|NCT02205359|183352525|SUPERIORITY||Hazard Ratio (HR)|0.888|STANDARD_ERROR_OF_MEAN|0.067||0.077|TWO_SIDED|95.0|0.779|1.013|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.013|0.779|0.077
91728431|NCT02205359|183352526|SUPERIORITY||Hazard Ratio (HR)|0.881|STANDARD_ERROR_OF_MEAN|0.081||0.12|TWO_SIDED|95.0|0.752|1.032|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.032|0.752|0.12
91728432|NCT02205359|183352527|SUPERIORITY||Hazard Ratio (HR)|0.906|STANDARD_ERROR_OF_MEAN|0.09||0.28|TWO_SIDED|95.0|0.759|1.082|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.082|0.759|0.28
91728433|NCT02205359|183352528|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.|Odds Ratio (OR)|0.888|STANDARD_ERROR_OF_MEAN|0.074||0.11|TWO_SIDED|95.0|0.768|1.026|||Regression, Logistic|Stratified by NYHA class and with investigational site as a random effect|Standard Error is on log-odds ratio scale|||1.026|0.768|0.11
91728434|NCT02205359|183352529|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.85|1.16|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect||||1.16|0.85|0.89
91728435|NCT02205359|183352530|SUPERIORITY||Difference in mean change from baseline|-0.07||||0.88|TWO_SIDED|95.0|-1.03|0.89|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.89|-1.03|0.88
91728436|NCT02205359|183352531|SUPERIORITY||Difference in mean change from baseline|0.0013||||0.75|TWO_SIDED|95.0|-0.0068|0.0094|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.0094|-0.0068|0.75
91728437|NCT02205359|183352532|SUPERIORITY||rate ratio|1.15||||0.52|TWO_SIDED|95.0|0.75|1.75|||negative binomial regression|Stratified by NYHA class||||1.75|0.75|0.52
91728438|NCT00480025|183352538|SUPERIORITY|RMF included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \>100 cigarettes and past smoker).|Treatment Efficacy|1.024||||0.7379|TWO_SIDED|95.0|0.891|1.177||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|Overall population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.||1.177|0.891|0.7379
91728439|NCT00480025|183352539|SUPERIORITY|RMF taken into account included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \> 100 cigarettes and past smoker).|Treatment Efficacy|0.97||||0.7572|TWO_SIDED|95.0|0.797|1.179||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|No-CT population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.||1.179|0.797|0.7572
91728440|NCT03681093|183352570|SUPERIORITY||Least Squares (LS) Mean|0.05|STANDARD_ERROR_OF_MEAN|0.323||0.979|TWO_SIDED|95.0|-0.59|0.7||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|Mixed Model for Repeated Measures (MMRM)|||||0.70|-0.59|0.979
91728441|NCT03681093|183352570|SUPERIORITY||LS Mean|-0.25|STANDARD_ERROR_OF_MEAN|0.319||0.656|TWO_SIDED|95.0|-0.88|0.39||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|MMRM|||||0.39|-0.88|0.656
91728442|NCT03681093|183352571|SUPERIORITY||LS Mean|0.64|STANDARD_ERROR_OF_MEAN|0.249||0.012|TWO_SIDED|95.0|0.15|1.14||Unadjusted p-value|MMRM|||||1.14|0.15|0.012
91728443|NCT03681093|183352571|SUPERIORITY||LS Mean|0.45|STANDARD_ERROR_OF_MEAN|0.248||0.074|TWO_SIDED|95.0|-0.04|0.94||Unadjusted p-value|MMRM|||||0.94|-0.04|0.074
91490816|NCT02983825|182854612|SUPERIORITY|Wilcoxon signed-rank test for nonparametric matched-pairs||||||0.02|||||||Sign test|||"Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs best CPAP"||||0.02
91490817|NCT04457336|182854623|OTHER|Assessment of dose response for change from baseline in log 17-OHP after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results were obtained by using a repeated measures random coefficient mixed-effects model and are reported as the -2loglikelihood results for both the full (including interaction terms) and reduced (excluding interaction terms) models.||||||0.8051||||||Dose response p-value|Mixed Models Analysis|The result for the -2loglikelihood full model was -580.2550766 log(ng/dL) and -583.2846546 log(ng/dL) for the reduced model.||||||0.8051
91490818|NCT03993132|182854668|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.91|
91490819|NCT03993132|182854669|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|1.01|1.13|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.13|1.01|
91728444|NCT03681093|183352572|SUPERIORITY||LS Mean|5.22|STANDARD_ERROR_OF_MEAN|4.881||0.288|TWO_SIDED|95.0|-4.49|14.93||Unadjusted p-value|MMRM|||||14.93|-4.49|0.288
91728445|NCT03681093|183352572|SUPERIORITY||LS Mean|-2.17|STANDARD_ERROR_OF_MEAN|4.936||0.661|TWO_SIDED|95.0|-11.99|7.65||Unadjusted p-value|MMRM|||||7.65|-11.99|0.661
91728446|NCT03681093|183352573|SUPERIORITY||LS Mean|0.61|STANDARD_ERROR_OF_MEAN|1.809||0.735|TWO_SIDED|95.0|-2.98|4.21||Unadjusted p-value|MMRM|||||4.21|-2.98|0.735
91728447|NCT03681093|183352573|SUPERIORITY||LS Mean|4.51|STANDARD_ERROR_OF_MEAN|1.821||0.015|TWO_SIDED|95.0|0.89|8.13||Unadjusted p-value|MMRM|||||8.13|0.89|0.015
91728448|NCT00368849|183352585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.63|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.63
91728449|NCT00368849|183352586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.09|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.09
91728450|NCT00368849|183352587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.46|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.46
91728451|NCT00368849|183352588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.84|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.84
91490820|NCT03993132|182854670|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.84|1.08|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.08|0.84|
91490821|NCT03993132|182854671|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.96|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.96|
91490822|NCT03993132|182854672|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.61|0.83|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.83|0.61|
91490823|NCT03993132|182854673|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.91|0.76|
91490824|NCT03993132|182854674|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
91490825|NCT03993132|182854675|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
91490826|NCT03993132|182854676|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
91490827|NCT03993132|182854677|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
91490828|NCT03993132|182854678|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.18|0.83|
91490829|NCT03993132|182854679|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.16|0.97|
91490830|NCT03993132|182854680|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.06|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.06|0.72|
91490831|NCT03993132|182854681|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.88|1.1|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.10|0.88|
91490832|NCT03407625|182854731|SUPERIORITY||Risk Ratio (RR)|1.0||||0.86|TWO_SIDED|95.0|0.95|1.05|||log binomial regression||||We used generalized estimating equations for the log binomial regression with cluster entered as a random effect.|1.05|0.95|0.86
91490833|NCT01064310|182854786|SUPERIORITY_OR_OTHER||Percentage of participants|49.26|||<|0.001|TWO_SIDED|90.0|37.0|61.5||The p value indicates the difference in preference for pazopanib versus sunitinib treatment|Prescotts test||The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.|||61.5|37.0|<0.001
91490834|NCT05147428|182854816|SUPERIORITY||Cox Proportional Hazard|0.99||||0.76|TWO_SIDED|95.0|0.94|1.04|||Log Rank|||For the primary analysis, we combined all three targeted medication classes (antipsychotics, sedative/hypnotics, or strong anticholinergics). We calculated Kaplan-Meier curves and performed log-rank testing, and estimated hazard ratios using Cox proportional hazards modeling, censoring at death or disenrollment from the health plan, or at the end of the 6-month study observation period, whichever came first. The index date for the survival analysis was the end of the 3-month blackout period.||1.04|0.94|0.76
91490835|NCT05147428|182854817|SUPERIORITY|||||||0.33|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.33
91490836|NCT05147428|182854818|SUPERIORITY|||||||0.55|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.55
91490837|NCT05147428|182854819|SUPERIORITY|||||||0.47|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.47
91490838|NCT05147428|182854820|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
91528282|NCT01288781|182931919|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.63
91528283|NCT01288781|182931920|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.20
91490839|NCT05147428|182854822|SUPERIORITY|||||||0.19|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.19
91490840|NCT05147428|182854823|SUPERIORITY|||||||0.46|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.46
91490841|NCT05147428|182854824|SUPERIORITY|||||||0.79|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.79
91490842|NCT00381485|182854838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91490843|NCT00381485|182854838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91490844|NCT00745823|182854843|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.7||||0.044|TWO_SIDED|95.0|-10.7|-0.83|||Miettinen and Nurminen|||||-0.83|-10.7|0.044
91490845|NCT00745823|182854844|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.1||||0.011|TWO_SIDED|95.0|-9.29|-1.06|||Miettinen and Nurminen|||||-1.06|-9.29|0.011
91490846|NCT00745823|182854845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-5.0|4.6|||Miettinen and Nurminen|||||4.6|-5.0|
91728452|NCT00368849|183352589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.76|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.76
91490847|NCT00745823|182854846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.3|2.0||||||||2.0|-1.3|
91490848|NCT00745823|182854847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.56|||||TWO_SIDED|95.0|-7.29|34.4|||t-test, 2 sided|||||34.40|-7.29|
91490849|NCT01206660|182854858|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91728453|NCT01902303|183352590|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Chi-squared|||||||>.5000
91490850|NCT01206660|182854859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91490851|NCT01206660|182854860|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91490852|NCT01633853|182854861|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline both in group Vitamin D2.||||0.117
91490853|NCT01633853|182854861|SUPERIORITY_OR_OTHER|||||||0.309|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline in group 1,25(OH)2 Vitamin D3.||||0.309
91490854|NCT01633853|182854861|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED|||||t=-0.593|t-test, 2 sided|||The levels of blood calcium at the 24th month of following up were compared between two groups.||||0.554
91490855|NCT01633853|182854862|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group Vitamin D2.||||<0.001
91728454|NCT01902303|183352591|SUPERIORITY_OR_OTHER|||||||0.3835|TWO_SIDED||||||Chi-squared|||||||.3835
91758851|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs7407451 Genotype: T/T||1.725|0.072|0.1764
91758852|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.2352|TWO_SIDED|95.0|0.201|1.501||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.501|0.201|0.2352
91758853|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.9674|TWO_SIDED|95.0|0.485|2.003||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.003|0.485|0.9674
91490856|NCT01633853|182854862|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group 1,25(OH)2 Vitamin D3.||||<0.001
91490857|NCT01633853|182854862|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P\<0.001, t=-14.982.|t-test, 2 sided|||The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups.||||<0.001
91490858|NCT01633853|182854863|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||Chi-square value=0.099|Chi-squared|||||||0.753
91490859|NCT01633853|182854864|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group Vitamin D2.||||<0.001
91490860|NCT01633853|182854864|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group 1,25(OH)2 Vitamin D3, respectively.||||<0.001
91490861|NCT01633853|182854864|SUPERIORITY_OR_OTHER|||||||0.694|TWO_SIDED|||||t=0.394|t-test, 2 sided|||The levels of blood phosphorus at the 24th month of following up were compared between two groups.||||0.694
91490862|NCT01633853|182854865|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline in group Vitamin D2.||||0.179
91490863|NCT01633853|182854865|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline group 1,25(OH)2 Vitamin D3, respectively.||||0.106
91728455|NCT05058456|183352619|OTHER|The primary safety hypothesis is: H0: ΠS \> PGS vs. HA: ΠS ≤ PGS where ΠS is the proportion of patients who experience a MAE within 30 days of procedure and PGS is the Safety Performance Goal. All subjects in whom a Mini S IVL catheter was introduced into the vasculature will be included in the analysis (i.e., it is an intent-to-treat analysis). The hypothesis will be tested using a one-sided Exact Binomial Test at α=0.025.|||||<|0.025|||||||Fisher Exact|||||||<.025
91490864|NCT01633853|182854865|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED|||||t=-0.736|t-test, 2 sided|||The levels of blood iPTH at the 24th month of following up were compared between two groups.||||0.463
91490865|NCT01258582|182854874|SUPERIORITY_OR_OTHER||difference in the acceptance rates|-0.022||||0.34|TWO_SIDED|95.0|-0.067|0.023|||Chi-squared|The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test.||Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).||0.023|-0.067|0.34
91490866|NCT01034631|182854952|OTHER|||||||0.6625|||||||Chi-squared|||||||.6625
91490867|NCT01292746|182854968|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|2 sided t-test for correlated samples.||||||<0.05
91490868|NCT01227434|182854976|SUPERIORITY_OR_OTHER||Exact binomial distribution|0.1||||0.1|TWO_SIDED||||||Exact binomial distribution|||Compared to historical estimates of PFS-6 months. With 30 patients, there would be 90% power to detect an improvement in the PFS-6 months rate from 10% (historical estimate) to 30% based on a one-sided exact test with alpha=0.1.||||0.10
91490869|NCT03486223|182854981|SUPERIORITY|||||||0.71||||||Wilcoxon signed-rank test was used for the within-subject comparison of GSK2256294 versus placebo.|Wilcoxon (Mann-Whitney)|||A sample size of 16 per group was estimated to have 86% power to detect a within-subject difference of 3.76 (80% of the above difference) or larger (with an SD for the within-subject difference of 4.6) in insulin sensitivity.||||0.71
91490870|NCT02417831|182854994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|105.76|STANDARD_DEVIATION|14.18|||TWO_SIDED|90.0|99.81|112.08|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||112.08|99.81|
91490871|NCT02417831|182854995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.4|STANDARD_DEVIATION|9.05|||TWO_SIDED|90.0|97.71|105.23|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.23|97.71|
91490872|NCT02417831|182854996|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.42|STANDARD_DEVIATION|8.85|||TWO_SIDED|90.0|97.81|105.17|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.17|97.81|
91490873|NCT01144286|182855002|SUPERIORITY_OR_OTHER||response rate (%)|80.0||||0.063|TWO_SIDED|95.0||||Significance level was set to α of 0.05 if the primary endpoint was significant, hierarchical testing was to be performed on the primary endpoint (each active dose X placebo). No other adjustment was made for testing multiple secondary outcomes.|Regression, Logistic|||"Primary analysis is the dose response at TOC based on the global therapeutic cure. Dose response will be tested using a logistic regression using linear coefficient for the treatment effect(Wald chi-square).~Assuming that the response rate is 80% for 600 mg, 75% for the 300 mg, 65% for 150 mg and 50% for the placebo group, a sample size of 45 subjects in each group will have 90% power to detect a linear dose response using a 0.05 two-sided test of trend based on the logistic model."||||0.0630
91490874|NCT00590720|182855008|SUPERIORITY_OR_OTHER|||||||0.4|||||||Two-sample t-test|||||||0.40
91728456|NCT05058456|183352620|OTHER|The primary effectiveness hypothesis is: H0: ΠE ≤ PGE vs. HA: ΠE \> PGE, where ΠE is the proportion of target lesions with technical success and PG is the effectiveness Performance Goal. One-sided statistical significance level of 0.025 = α. The hypothesis will be tested using a one-sided Exact Binomial Test.|||||<|0.025|||||||Fisher Exact|||||||<.025
91490875|NCT00590720|182855009|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Two-sample t-test|||||||<0.01
91490876|NCT00590720|182855010|SUPERIORITY_OR_OTHER|||||||0.53|||||||Two-sample t-test|||||||0.53
91490877|NCT00590720|182855011|SUPERIORITY_OR_OTHER|||||||0.22|||||||Two-sample t-test|||||||0.22
91728457|NCT02802865|183352628|SUPERIORITY||Rate ratio|1.8||||0.007|TWO_SIDED|95.0|1.18|2.75|||Chi-squared, Corrected|||||2.75|1.18|0.007
91728458|NCT02802865|183352629|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91728459|NCT02802865|183352630|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91728460|NCT02802865|183352631|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91728461|NCT02802865|183352632|SUPERIORITY|||||||0.709|||||||Chi-squared|||This study was not powered to detect significant between-group differences for this conception.||||0.709
91728462|NCT02802865|183352633|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for clinical pregnancy.||||0.356
91728463|NCT02802865|183352635|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for live birth.||||0.356
91728464|NCT02802865|183352636|SUPERIORITY|||||||0.486|||||||Chi-squared, Corrected|||This study was not powered to detect significant between-group differences for pregnancy loss.||||0.486
91728465|NCT03931785|183352639|SUPERIORITY||Least squares (LS) mean difference|0.08||||0.7467|TWO_SIDED|95.0|-0.42|0.58|||MMRM||MD-7246 minus placebo|||0.58|-0.42|0.7467
91728466|NCT03931785|183352639|SUPERIORITY||LS mean difference|0.43||||0.0941|TWO_SIDED|95.0|-0.07|0.93|||MMRM||MD-7246 minus placebo|||0.93|-0.07|0.0941
91490878|NCT00590720|182855012|SUPERIORITY_OR_OTHER|||||||0.16|||||||Two-sample t-test|||||||0.16
91490879|NCT00590720|182855013|SUPERIORITY_OR_OTHER|||||||0.52|||||||Two-sample t-test|||||||0.52
91490880|NCT02527161|182855036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91490881|NCT02527161|182855037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Pain||||<0.0001
91728467|NCT03931785|183352639|SUPERIORITY||LS mean difference|0.06||||0.8098|TWO_SIDED|95.0|-0.44|0.56|||MMRM||MD-7246 minus placebo|||0.56|-0.44|0.8098
91728468|NCT03931785|183352640|SUPERIORITY||Difference in Responder Rate|1.0|||||TWO_SIDED|95.0|-12.9|15.0|||||Difference in responder rate (MD-7246 - placebo). 95% confidence intervals (CIs) for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||15.0|-12.9|
91728469|NCT03931785|183352640|SUPERIORITY||Difference in Responder Rate|-11.3|||||TWO_SIDED|95.0|-25.3|2.6|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||2.6|-25.3|
91728470|NCT03931785|183352640|SUPERIORITY||Difference in Responder Rate|-7.2|||||TWO_SIDED|95.0|-21.2|6.8|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||6.8|-21.2|
91728471|NCT03931785|183352640|SUPERIORITY||Odds Ratio (OR)|1.043||||0.8852|TWO_SIDED|95.0|0.591|1.839|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.839|0.591|0.8852
91728472|NCT03931785|183352640|SUPERIORITY||Odds Ratio (OR)|0.634||||0.1152|TWO_SIDED|95.0|0.36|1.117|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.117|0.360|0.1152
91728473|NCT03931785|183352640|SUPERIORITY||Odds Ratio (OR)|0.749||||0.3157|TWO_SIDED|95.0|0.425|1.317|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.317|0.425|0.3157
91728474|NCT01292473|183352646|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69||||0.4637|TWO_SIDED|95.0|-2.54|1.16||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.16|-2.54|0.4637
91728475|NCT01292473|183352646|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.0011|TWO_SIDED|95.0|-4.85|-1.24||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.24|-4.85|0.0011
91728476|NCT01292473|183352646|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.81|||<|0.0001|TWO_SIDED|95.0|-6.49|-3.13||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-3.13|-6.49|<0.0001
91728477|NCT01292473|183352647|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.73||||0.1575|TWO_SIDED|95.0|-6.53|1.07||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.07|-6.53|0.1575
91728478|NCT01292473|183352647|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.69||||0.0001||95.0|-11.49|-3.88||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-3.88|-11.49|0.0001
91728479|NCT01292473|183352647|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.4|||<|0.0001|TWO_SIDED|95.0|-16.13|-8.66||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-8.66|-16.13|<0.0001
91728480|NCT01292473|183352648|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01||||0.0603|TWO_SIDED|95.0|-4.11|0.09||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.09|-4.11|0.0603
91490882|NCT02527161|182855037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Pain||||0.0013
91490883|NCT02527161|182855037|SUPERIORITY|||||||0.3316|||||||ANOVA|||Change from 3 months to 6 months KOOS Pain||||0.3316
91490884|NCT02527161|182855037|SUPERIORITY|||||||0.3366|||||||ANOVA|||Change from 6 months to 1 year KOOS Pain||||0.3366
91490885|NCT02527161|182855037|SUPERIORITY|||||||0.9826|||||||ANOVA|||Change from 1 year to 2 year KOOS Pain||||0.9826
91490886|NCT02527161|182855037|SUPERIORITY|||||||0.9276|||||||ANOVA|||Change from 2 year to 5 year KOOS Pain||||0.9276
91490887|NCT02527161|182855038|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Symptoms||||<0.0001
91490888|NCT02527161|182855038|SUPERIORITY|||||||0.0736|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Symptoms||||0.0736
91490889|NCT02527161|182855038|SUPERIORITY|||||||0.4675|||||||ANOVA|||Change from 3 months to 6 months KOOS Symptoms||||0.4675
91490890|NCT02527161|182855038|SUPERIORITY|||||||0.0229|||||||ANOVA|||Change from 6 months to 1 year KOOS Symptoms||||0.0229
91490891|NCT02527161|182855038|SUPERIORITY|||||||0.9968|||||||ANOVA|||Change from 1 year to 2 year KOOS Symptoms||||0.9968
91490892|NCT02527161|182855038|SUPERIORITY|||||||0.7761|||||||ANOVA|||Change from 2 year to 5 year KOOS Symptoms||||0.7761
91490893|NCT02527161|182855039|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS ADL||||<0.0001
91490894|NCT02527161|182855039|SUPERIORITY|||||||0.0212|||||||ANOVA|||Change from 6 weeks to 3 months KOOS ADL||||0.0212
91490895|NCT02527161|182855039|SUPERIORITY|||||||0.7173|||||||ANOVA|||Change from 3 months to 6 months KOOS ADL||||0.7173
91490896|NCT02527161|182855039|SUPERIORITY|||||||0.1834|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.1834
91490897|NCT02527161|182855039|SUPERIORITY|||||||0.9957|||||||ANOVA|||Change from 1 year to 2 year KOOS ADL||||0.9957
91490898|NCT02527161|182855039|SUPERIORITY|||||||0.9999|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.9999
91490899|NCT02527161|182855040|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS S\&R||||<0.0001
91490900|NCT02527161|182855040|SUPERIORITY|||||||0.0522|||||||ANOVA|||Change from 6 weeks to 3 months KOOS S\&R||||0.0522
91490901|NCT02527161|182855040|SUPERIORITY|||||||0.1696|||||||ANOVA|||Change from 3 months to 6 months KOOS S\&R||||0.1696
91490902|NCT02527161|182855040|SUPERIORITY|||||||0.6942|||||||ANOVA|||Change from 6 months to 1 year KOOS S\&R||||0.6942
91490903|NCT02527161|182855040|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KOOS S\&R||||>0.9999
91490904|NCT02527161|182855040|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS S\&R||||>0.9999
91490905|NCT02527161|182855041|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS QoL||||<0.0001
91490906|NCT02527161|182855041|SUPERIORITY|||||||0.0135|||||||ANOVA|||Change from 6 weeks to 3 months KOOS QoL||||0.0135
91490907|NCT02527161|182855041|SUPERIORITY|||||||0.0829|||||||ANOVA|||Change from 3 months to 6 months KOOS QoL||||0.0829
91490908|NCT02527161|182855041|SUPERIORITY|||||||0.1729|||||||ANOVA|||Change from 6 months to 1 year KOOS QoL||||0.1729
91490909|NCT02527161|182855041|SUPERIORITY|||||||0.9687|||||||ANOVA|||Change from 1 year to 2 year KOOS QoL||||0.9687
91490910|NCT02527161|182855041|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS QoL||||>0.9999
91490911|NCT02527161|182855042|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 PCS||||<0.0001
91490912|NCT02527161|182855042|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 PCS||||<0.0001
91490913|NCT02527161|182855042|SUPERIORITY|||||||0.8189|||||||ANOVA|||Change from 3 months to 6 months SF-12 PCS||||0.8189
91490914|NCT02527161|182855042|SUPERIORITY|||||||0.9845|||||||ANOVA|||Change from 6 months to 1 year SF-12 PCS||||0.9845
91490915|NCT02527161|182855042|SUPERIORITY|||||||0.75|||||||ANOVA|||Change from 1 year to 2 year SF-12 PCS||||0.7500
91490916|NCT02527161|182855042|SUPERIORITY|||||||0.1376|||||||ANOVA|||Change from 2 year to 5 year SF-12 PCS||||0.1376
91490917|NCT02527161|182855043|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 week VAS Rest||||<0.0001
91490918|NCT02527161|182855043|SUPERIORITY|||||||0.0031|||||||ANOVA|||Change from 6 weeks to 3 months VAS Rest||||0.0031
91490919|NCT02527161|182855043|SUPERIORITY|||||||0.299|||||||ANOVA|||Change from 3 months to 6 months VAS Rest||||0.2990
91490920|NCT02527161|182855043|SUPERIORITY|||||||0.9832|||||||ANOVA|||Change from 6 months to 1 year VAS Rest||||0.9832
91490921|NCT02527161|182855043|SUPERIORITY|||||||0.9991|||||||ANOVA|||Change from 1 year to 2 year VAS Rest||||0.9991
91490922|NCT02527161|182855043|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year VAS Rest||||>0.9999
91490923|NCT02527161|182855044|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks VAS Mob||||<0.0001
91490924|NCT02527161|182855044|SUPERIORITY|||||||0.0062|||||||ANOVA|||Change from 6 weeks to 3 months VAS Mob||||0.0062
91490925|NCT02527161|182855044|SUPERIORITY|||||||0.373|||||||ANOVA|||Change from 3 months to 6 months VAS Mob||||0.3730
91490926|NCT02527161|182855044|SUPERIORITY|||||||0.8499|||||||ANOVA|||Change from 6 months to 1 year VAS Mob||||0.8499
91490927|NCT02527161|182855044|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year VAS Mob||||>0.9999
91490928|NCT02527161|182855044|SUPERIORITY|||||||0.9958|||||||ANOVA|||Change from 2 year to 5 year VAS Mob||||0.9958
91490929|NCT02527161|182855045|SUPERIORITY|||||||0.3493|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 MCS||||0.3493
91490930|NCT02527161|182855045|SUPERIORITY|||||||0.48|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 MCS||||0.4800
91490931|NCT02527161|182855045|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 3 months to 6 months SF-12 MCS||||>0.9999
91490932|NCT02527161|182855045|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 6 months to 1 year SF-12 MCS||||>0.9999
91728481|NCT01292473|183352648|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.51|||<|0.0001|TWO_SIDED|95.0|-6.65|-2.36||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-2.36|-6.65|<0.0001
91728482|NCT01292473|183352648|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.09|||<|0.0001|TWO_SIDED|95.0|-9.26|-4.93||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-4.93|-9.26|<0.0001
91728483|NCT01292473|183352649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.0478|TWO_SIDED|95.0|1.0|2.05||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between Placebo and Omalizumab 75 mg.||2.05|1.00|0.0478
91728484|NCT01292473|183352649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.0101|TWO_SIDED|95.0|1.12|2.26||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||2.26|1.12|0.0101
91728485|NCT01292473|183352649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.48|3.03||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||3.03|1.48|<0.0001
91728486|NCT01292473|183352650|SUPERIORITY_OR_OTHER|||||||0.3419||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.3419
91728487|NCT01292473|183352650|SUPERIORITY_OR_OTHER|||||||0.001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0010
91490933|NCT02527161|182855045|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year SF-12 MCS||||>0.9999
91490934|NCT02527161|182855045|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year SF-12 MCS||||>0.9999
91490935|NCT02527161|182855046|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KSS Pain||||<0.0001
91490936|NCT02527161|182855046|SUPERIORITY|||||||0.9465|||||||ANOVA|||Change from 3 months to 6 months KSS Pain||||0.9465
91490937|NCT02527161|182855046|SUPERIORITY|||||||0.1215|||||||ANOVA|||Change from 6 months to 1 year KSS Pain||||0.1215
91490938|NCT02527161|182855046|SUPERIORITY|||||||0.9912|||||||ANOVA|||Change from 1 year to 2 years KSS Pain||||0.9912
91490939|NCT02527161|182855046|SUPERIORITY|||||||0.8952|||||||ANOVA|||Change from 2 year to 5 year KSS Pain||||0.8952
91490940|NCT02527161|182855047|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 3 months KSS Function||||<0.0001
91490941|NCT02527161|182855047|SUPERIORITY|||||||0.0266|||||||ANOVA|||Change from 3 months to 6 months KSS Function||||0.0266
91490942|NCT02527161|182855047|SUPERIORITY|||||||0.988|||||||ANOVA|||Change from 6 months to 1 year KSS Function||||0.9880
91728488|NCT01292473|183352650|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||||<0.0001
91728489|NCT01292473|183352651|SUPERIORITY_OR_OTHER|||||||0.4366||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.4366
91728490|NCT01292473|183352651|SUPERIORITY_OR_OTHER|||||||0.0045||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0045
91728491|NCT01292473|183352651|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||||<0.0001
91490943|NCT02527161|182855047|SUPERIORITY|||||||0.9699|||||||ANOVA|||Change from 1 year to 2 years KSS Function||||0.9699
91728492|NCT01292473|183352652|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48||||0.0082|TWO_SIDED|95.0|-4.32|-0.65||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||-0.65|-4.32|0.0082
91728493|NCT01292473|183352652|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.61|-1.9||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.90|-5.61|<0.0001
91728494|NCT01292473|183352652|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.15|||<|0.0001|TWO_SIDED|95.0|-9.03|-5.27||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and the omalizumab 300 mg groups.||-5.27|-9.03|<0.0001
91728495|NCT01292473|183352653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.68||||0.1207|TWO_SIDED|95.0|-3.82|0.45||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.45|-3.82|0.1207
91728496|NCT01292473|183352653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.51||||0.0215|TWO_SIDED|95.0|-4.64|-0.38||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-0.38|-4.64|0.0215
91728497|NCT01292473|183352653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.79||||0.0004|TWO_SIDED|95.0|-5.85|-1.73||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-1.73|-5.85|0.0004
91728498|NCT01292473|183352654|SUPERIORITY_OR_OTHER|||||||0.1361||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.1361
91728499|NCT01292473|183352654|SUPERIORITY_OR_OTHER|||||||0.0905||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0905
91490944|NCT02527161|182855047|SUPERIORITY|||||||0.8575|||||||ANOVA|||Change from 2 year to 5 years KSS Function||||0.8575
91490945|NCT02527161|182855048|SUPERIORITY|||||||0.8581|||||||ANOVA|||Change from preoperative to 3 months KSS Range of Motion||||0.8581
91490946|NCT02527161|182855048|SUPERIORITY|||||||0.7664|||||||ANOVA|||Change from 3 months to 6 months KSS Range of Motion||||0.7664
91490947|NCT02527161|182855048|SUPERIORITY|||||||0.7022|||||||ANOVA|||Change from 6 months to 1 year KSS Range of Motion||||0.7022
91728500|NCT01292473|183352654|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg.||||<0.0001
91728501|NCT00337194|183352709|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.06
91728502|NCT00337194|183352710|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
91728503|NCT00159874|183352748|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.02|STANDARD_ERROR_OF_MEAN|6.1||0.253|TWO_SIDED|95.0|-19.13|5.09|||ANCOVA||Least square mean difference of -7.02 was calculated as ' Sildenafil Medium Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||5.09|-19.13|0.253
91728504|NCT00159874|183352748|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|5.92||0.1|TWO_SIDED|95.0|-21.6|1.93|||ANCOVA||Least square mean difference of -9.84 was calculated as ' Sildenafil High Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||1.93|-21.60|0.100
91758854|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.3524|TWO_SIDED|95.0|0.235|1.686||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||1.686|0.235|0.3524
91758855|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.809||||0.6652|TWO_SIDED|95.0|0.308|2.124||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||2.124|0.308|0.6652
91758856|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.5931|TWO_SIDED|95.0|0.436|1.618||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||1.618|0.436|0.5931
91758857|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.475||||0.2625|TWO_SIDED|95.0|0.125|1.813||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.813|0.125|0.2625
91758858|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.2168|TWO_SIDED|95.0|0.4|1.239||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.239|0.400|0.2168
91758859|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987||||0.9802|TWO_SIDED|95.0|0.353|2.759||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||2.759|0.353|0.9802
91758860|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.652||||0.1145|TWO_SIDED|95.0|0.378|1.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||1.122|0.378|0.1145
91728505|NCT00159874|183352748|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.82|STANDARD_ERROR_OF_MEAN|6.01||0.64|TWO_SIDED|95.0|-14.75|9.11|||ANCOVA||Least square mean difference of -2.82 was calculated as ' Sildenafil High Dose - Medium Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||9.11|-14.75|0.640
91728506|NCT01104870|183352765|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.95
91728507|NCT01104870|183352765|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.27
91728508|NCT00276380|183352791|OTHER||Odds Ratio (OR)|0.83||||0.52|TWO_SIDED|95.0|0.46|1.48|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.48|0.46|0.52
91728509|NCT00276380|183352792|OTHER|Comparison of treatment effect at Day 28|Odds Ratio (OR)|0.86||||0.623|TWO_SIDED|95.0|0.47|1.57|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.57|0.47|0.623
91728510|NCT00276380|183352792|OTHER|Comparison of treatment effect at Day 84|Odds Ratio (OR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.3|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.3|0.42|0.3
91728511|NCT00276380|183352794|OTHER|||||||0.207||||||Treatment effect was derived using a parametric analysis of covariance (ANCOVA) with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.207
91490948|NCT02527161|182855048|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KSS Range of Motion||||>0.9999
91490949|NCT02527161|182855048|SUPERIORITY|||||||0.2943|||||||ANOVA|||Change from 2 year to 5 year KSS Range of Motion||||0.2943
91490950|NCT02527161|182855049|SUPERIORITY|||||||0.0161|||||||ANOVA|||Change from 1 year to 2 year Forgotten Joint Score||||0.0161
91490951|NCT02527161|182855049|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 2 year to 5 year Forgotten Joint Score||||<0.0001
91490952|NCT02609828|182855050|SUPERIORITY||Differences in least square (LS) mean|-0.78|STANDARD_ERROR_OF_MEAN|0.37||0.0381|TWO_SIDED|95.0|-1.52|-0.04|||ANCOVA|||Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.04|-1.52|0.0381
91490953|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0497|TWO_SIDED|95.0|-0.72|0.0|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.00|-0.72|0.0497
91728512|NCT00276380|183352794|OTHER|||||||0.59||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.590
91728513|NCT00276380|183352794|OTHER|Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.||||||0.814|||||||ANCOVA|||Comparison of treatment effect at Day 168||||0.814
91728514|NCT00276380|183352795|OTHER|||||||0.24||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.240
91728515|NCT00276380|183352795|OTHER|||||||0.441||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.441
91728516|NCT00276380|183352795|OTHER|||||||0.645||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 168||||0.645
91728517|NCT00276380|183352796|OTHER|||||||0.623||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.623
91728518|NCT00276380|183352796|OTHER|||||||0.338||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.338
91728519|NCT00276380|183352796|OTHER|||||||0.828||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates|ANCOVA|||Comparison of treatment effect at Day 168||||0.828
91728520|NCT03654326|183352798|SUPERIORITY||Difference in Least Squares Mean|-0.5||||0.066|TWO_SIDED|95.0|-1.01|0.03||Based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|ANCOVA|||||0.03|-1.01|0.066
91728521|NCT03654326|183352799|OTHER|Difference in percentage of participants who experienced one or more adverse events|Difference in % vs Placebo|17.7|||||TWO_SIDED|95.0|3.4|31.3|||||Based on Miettinen \& Nurminen method|||31.3|3.4|
91728522|NCT03654326|183352800|OTHER|Difference in percentage of participants who discontinued study drug due to an adverse event|Difference in % vs Placebo|3.2|||||TWO_SIDED|95.0|-0.9|9.0|||||Based on Miettinen \& Nurminen method|||9.0|-0.9|
91728523|NCT03654326|183352801|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.6|||||TWO_SIDED|95.0|-1.18|-0.06||||||||-0.06|-1.18|
91728524|NCT03654326|183352802|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.5|||||TWO_SIDED|95.0|-1.04|0.03||||||||0.03|-1.04|
91728525|NCT05287685|183352803|OTHER|||||||0.29|||||||t-test, 2 sided|||Preliminary pre-post outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.29
91728526|NCT05287685|183352803|OTHER|||||||0.34|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.34
91490954|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.66|STANDARD_ERROR_OF_MEAN|0.25||0.0092|TWO_SIDED|95.0|-1.16|-0.17|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.16|0.0092
91728527|NCT05287685|183352803|SUPERIORITY|||||||0.02|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.02
91728528|NCT05287685|183352803|SUPERIORITY|||||||0.04|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.04
91728529|NCT05287685|183352804|OTHER|||||||0.88|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.88
91728530|NCT05287685|183352804|OTHER|||||||0.87|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.87
91728531|NCT05287685|183352804|SUPERIORITY|||||||0.1|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.10
91728532|NCT05287685|183352804|SUPERIORITY|||||||0.9|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.90
91728533|NCT05287685|183352805|EQUIVALENCE|Analysis to test whether groups had equivalent levels of satisfaction with treatment (defined as the groups not being significantly different at the level of p\<.05).||||||0.8|||||||t-test, 2 sided|||T-test analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups.||||.80
91490955|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.32||0.0218|TWO_SIDED|95.0|-1.37|-0.11|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.11|-1.37|0.0218
91490956|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.87|STANDARD_ERROR_OF_MEAN|0.36||0.0154|TWO_SIDED|95.0|-1.58|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.58|0.0154
91490957|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.39||0.1289|TWO_SIDED|95.0|-1.36|0.17|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.36|0.1289
91490958|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|0.44||0.211|TWO_SIDED|95.0|-1.43|0.32|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.43|0.2110
91696863|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.906|||||TWO_SIDED|95.0|1.177|3.087||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.087|1.177|
91696864|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.945|||||TWO_SIDED|95.0|0.583|1.533||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.533|0.583|
91696865|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.763|||||TWO_SIDED|95.0|0.468|1.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.245|0.468|
91728534|NCT05287685|183352806|OTHER|||||||0.35|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.35
91728535|NCT05287685|183352806|OTHER|||||||0.049|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.049
91728536|NCT05287685|183352806|SUPERIORITY|||||||0.45|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.45
91728537|NCT05287685|183352806|SUPERIORITY|||||||0.2|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.20
91696866|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.818|||||TWO_SIDED|95.0|1.119|2.956||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.956|1.119|
91728538|NCT05287685|183352807|OTHER|||||||0.006|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.006
91728539|NCT05287685|183352807|OTHER|||||||0.011|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.011
91728540|NCT05287685|183352807|SUPERIORITY|||||||0.22|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.22
91728541|NCT05287685|183352807|SUPERIORITY|||||||0.25|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.25
91758861|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.7725|TWO_SIDED|95.0|0.36|3.946||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||3.946|0.360|0.7725
91490959|NCT02609828|182855051|SUPERIORITY||Difference in LS mean|-0.58|STANDARD_ERROR_OF_MEAN|0.46||0.2049|TWO_SIDED|95.0|-1.49|0.32|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.49|0.2049
91696867|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.917|||||TWO_SIDED|95.0|0.568|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.568|
91696868|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.855|||||TWO_SIDED|95.0|0.524|1.396||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.396|0.524|
91696869|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.203|||||TWO_SIDED|95.0|0.745|1.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.943|0.745|
91696870|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.496|||||TWO_SIDED|95.0|0.31|0.794||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.794|0.310|
91696871|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.4|||||TWO_SIDED|95.0|0.25|0.641||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.641|0.250|
91696872|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.954|||||TWO_SIDED|95.0|0.596|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.596|
91696873|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.481|||||TWO_SIDED|95.0|0.306|0.758||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.758|0.306|
91696874|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.449|||||TWO_SIDED|95.0|0.279|0.722||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.722|0.279|
91728542|NCT04829214|183352808|SUPERIORITY||Risk Difference (RD)|-10.2|STANDARD_ERROR_OF_MEAN|7.9|=|0.385|TWO_SIDED|95.0|-26.0|5.0|||Mantel Haenszel|||The percentage of responders will be compared between the two groups using the Mantel Haenszel test controlling for category of duration of tinnitus and category of baseline TFI overall score. The primary efficacy analysis will be conducted for the comparison of OTO-313 and placebo, using a 2-sided test and an alpha level of 5%. The 95% confidence intervals (CI) around the common risk difference will also be provided.||5|-26|=0.385
91728543|NCT04543786|183352846|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 2.|Mean Difference (Final Values)|2.8||||0.0048|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|One-way||||||0.0048
91758862|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.3286|TWO_SIDED|95.0|0.321|1.473||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||1.473|0.321|0.3286
91758863|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.948|TWO_SIDED|95.0|0.47|2.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||2.028|0.470|0.9480
91528284|NCT01288781|182931921|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||<0.01
91528285|NCT01288781|182931921|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Step down Holm Bonferroni correction was applied|t-test, 2 sided|||Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point.||||<0.01
91696875|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.631|||||TWO_SIDED|95.0|0.398|1.002||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.002|0.398|
91696876|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.807|||||TWO_SIDED|95.0|0.5|1.304||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.304|0.500|
91696877|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.924|||||TWO_SIDED|95.0|1.193|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.193|
91696878|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.97|||||TWO_SIDED|95.0|0.611|1.541||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.541|0.611|
91696879|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.905|||||TWO_SIDED|95.0|0.561|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.561|
91728544|NCT04543786|183352847|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 3.|Mean Difference (Final Values)|3.72|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||< 0.001
91728545|NCT04543786|183352848|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 4.|Mean Difference (Final Values)|3.24|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
91728546|NCT04543786|183352849|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|20.84|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
91728547|NCT04543786|183352851|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|26.78|||<|0.001|TWO_SIDED|||||p \< 0.05 was considered significant|t-test, 2 sided|paired||||||<0.001
91728548|NCT04543786|183352852|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
91728549|NCT04543786|183352853|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|2.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
91728550|NCT04543786|183352854|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
91728551|NCT04543786|183352855|OTHER|No comparison was made to another intervention or therapy.|Mean Difference (Final Values)|1.5||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
91728552|NCT02046200|183352860|SUPERIORITY_OR_OTHER|||||||0.0563|||||||ANOVA|||||||0.0563
91728553|NCT02046200|183352861|SUPERIORITY_OR_OTHER|||||||0.0342|||||||ANOVA|||||||0.0342
91728554|NCT02046200|183352862|SUPERIORITY_OR_OTHER|||||||0.1597|||||||ANOVA|||||||0.1597
91728555|NCT02046200|183352863|SUPERIORITY_OR_OTHER|||||||0.7617|||||||ANOVA|||||||0.7617
91728556|NCT02046200|183352864|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||||||0.93
91728557|NCT02046200|183352865|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||||||0.95
91728558|NCT02046200|183352866|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||||||0.43
91728559|NCT02046200|183352867|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
91490960|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1103|TWO_SIDED|95.0|-0.73|0.07|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.07|-0.73|0.1103
91490961|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.73|STANDARD_ERROR_OF_MEAN|0.27||0.0084|TWO_SIDED|95.0|-1.26|-0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.19|-1.26|0.0084
91490962|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.75|STANDARD_ERROR_OF_MEAN|0.33||0.0236|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|||Change at Week 4:ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.10|-1.39|0.0236
91490963|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.36||0.0155|TWO_SIDED|95.0|-1.59|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.59|0.0155
91490964|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.0505|TWO_SIDED|95.0|-1.52|0.0|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.00|-1.52|0.0505
91528286|NCT01288781|182931922|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
91528287|NCT01288781|182931923|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
91528288|NCT01288781|182931924|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
91490965|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.72|STANDARD_ERROR_OF_MEAN|0.4||0.0761|TWO_SIDED|95.0|-1.52|0.08|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.08|-1.52|0.0761
91490966|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.48||0.1263|TWO_SIDED|95.0|-1.7|0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.21|-1.70|0.1263
91490967|NCT02609828|182855052|SUPERIORITY||Difference in LS mean|-0.79|STANDARD_ERROR_OF_MEAN|0.49||0.1051|TWO_SIDED|95.0|-1.76|0.17|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.76|0.1051
91528289|NCT01946243|182931925|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0029
91528290|NCT01946243|182931926|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|4.2|||||ONE_SIDED|97.5|2.7||||||Units: Percent Accuracy||||2.7|
91490968|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.3003|TWO_SIDED|95.0|-1.47|0.47|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.47|-1.47|0.3003
91528291|NCT01946243|182931927|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.06|||||TWO_SIDED|95.0|0.018|0.112||||||Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.||0.112|0.018|
91728560|NCT02046200|183352868|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||||||0.21
91728561|NCT02046200|183352869|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||||||0.09
91728562|NCT02046200|183352870|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||||||0.99
91728563|NCT02965976|183352886|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
91728564|NCT02965976|183352887|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
91728565|NCT02965976|183352888|SUPERIORITY|||||||0.368|||||||t-test, 2 sided|||||||0.368
91728566|NCT02965976|183352889|SUPERIORITY|||||||0.987|||||||t-test, 2 sided|||||||0.987
91728567|NCT02965976|183352890|SUPERIORITY|||||||0.423|||||||Cochran-Mantel-Haenszel|||||||0.423
91728568|NCT02965976|183352891|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.000
91728569|NCT00407030|183352904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-12.0|-5.9||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-5.9|-12.0|<0.001
91728570|NCT00407030|183352910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.001|TWO_SIDED|95.0|-10.4|-4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-4.6|-10.4|<0.001
91728571|NCT00407030|183352911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.447|TWO_SIDED|95.0|-2.1|4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||4.6|-2.1|0.447
91728572|NCT01370642|183352919|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.0|||<|0.001|TWO_SIDED|95.0|17.2|40.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by Interleukin 28B (IL28B) and age utilizing Cochran-Mantel-Haenszel weights.||40.5|17.2|<0.001
91490969|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-0.84|STANDARD_ERROR_OF_MEAN|0.59||0.1603|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.35|-2.03|0.1603
91728573|NCT01370642|183352919|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|28.6|||<|0.001|TWO_SIDED|95.0|17.4|40.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||40.0|17.4|<0.001
91728574|NCT01370642|183352920|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|30.0|||<|0.001|TWO_SIDED|95.0|18.1|41.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.5|18.1|<0.001
91728575|NCT01370642|183352920|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.6|||<|0.001|TWO_SIDED|95.0|18.3|41.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.0|18.3|<0.001
91728576|NCT01370642|183352921|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|78.1|||<|0.001|TWO_SIDED|95.0|68.2|85.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||85.3|68.2|<0.001
91728577|NCT01370642|183352921|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|76.7|||<|0.001|TWO_SIDED|95.0|66.7|84.1|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||84.1|66.7|<0.001
91728578|NCT01370642|183352922|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|48.4|||<|0.001|TWO_SIDED|95.0|37.2|58.9|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||58.9|37.2|<0.001
91758864|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.3844|TWO_SIDED|95.0|0.125|2.282||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||2.282|0.125|0.3844
91728579|NCT01370642|183352922|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|49.6|||<|0.001|TWO_SIDED|95.0|38.5|60.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||60.0|38.5|<0.001
91490970|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2298|TWO_SIDED|95.0|-2.13|0.53|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.53|-2.13|0.2298
91528292|NCT01946243|182931928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|2.3|||||ONE_SIDED|97.5|0.8||||||Units: Percent Accuracy||||0.8|
91696880|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.273|||||TWO_SIDED|95.0|0.798|2.03||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.030|0.798|
91728580|NCT01370642|183352923|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.0|||<|0.001|TWO_SIDED|95.0|8.1|27.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.3|8.1|<0.001
91728581|NCT01370642|183352923|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.8|||<|0.001|TWO_SIDED|95.0|9.3|27.8|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.8|9.3|<0.001
91728582|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|4.1||||0.385|TWO_SIDED|95.0|-5.4|13.7|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||13.7|-5.4|0.385
91728583|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|-2.2||||0.67|TWO_SIDED|95.0|-12.6|8.1|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||8.1|-12.6|0.670
91728584|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|-4.1||||0.557|TWO_SIDED|95.0|-17.5|9.5|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||9.5|-17.5|0.557
91728585|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|-12.7||||0.072|TWO_SIDED|95.0|-26.2|1.2|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||1.2|-26.2|0.072
91728586|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|0.0|||>|0.999|TWO_SIDED|95.0|-7.9|7.9|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||7.9|-7.9|>0.999
91728587|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|5.2||||0.22|TWO_SIDED|95.0|-3.3|14.2|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||14.2|-3.3|0.220
91728588|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|15.3||||0.032|TWO_SIDED|95.0|1.3|28.7|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||28.7|1.3|0.032
91728589|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|5.6||||0.432|TWO_SIDED|95.0|-8.4|19.4|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||19.4|-8.4|0.432
91728590|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|8.2||||0.252|TWO_SIDED|95.0|-5.8|21.8|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||21.8|-5.8|0.252
91728591|NCT01370642|183352924|SUPERIORITY_OR_OTHER||Difference in percentages|0.5||||0.942|TWO_SIDED|95.0|-13.4|14.4|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||14.4|-13.4|0.942
91728592|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.2|||||TWO_SIDED|95.0|-3.5|-3.0|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.0|-3.5|
91728593|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.5|||||TWO_SIDED|95.0|-3.7|-3.2|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.2|-3.7|
91728594|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.0|||||TWO_SIDED|95.0|-3.3|-2.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.7|-3.3|
91758865|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.662||||0.1373|TWO_SIDED|95.0|0.381|1.153||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.153|0.381|0.1373
91728595|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.1|||||TWO_SIDED|95.0|-3.4|-2.8|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.8|-3.4|
91728596|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-1.9|||||TWO_SIDED|95.0|-2.2|-1.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.6|-2.2|
91728597|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-2.0|||||TWO_SIDED|95.0|-2.3|-1.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.7|-2.3|
91728598|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
91728599|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
91728600|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.5|-1.1|
91728601|NCT01370642|183352925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.9|||||TWO_SIDED|95.0|-1.2|-0.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.6|-1.2|
91728602|NCT01378273|183352944|SUPERIORITY|We assumed no effect of treatment on death, but that Epo will lead to a decrease in the rate of NDI. If we assume a multiplicative reduction in the NDI rate of 0.45 then we expect a treated NDI rate of 12 percent and an overall rate of death+NDI of 30.4% as compared to the control rate of 40.4% corresponding to an overall treatment rate ratio of 0.75. This leads to a sample size of 376 evaluated subjects per arm or a total evaluated sample size of 752 subjects.|Risk Ratio (RR)|1.03||||0.05|TWO_SIDED|0.05|0.81|1.32||A two-sided type I error of 0.05 with no formal adjustment for multiple comparisons unless otherwise specified (such as with safety outcomes).|GEE Wald test based on logistic regressi|adjustments were made for gestational age at birth and recruitment site as a fixed effect.|The numerator is the Epo group, denominator is the control group|We evaluated the primary outcome of death or neurodevelopmental impairment using generalized estimating equations to account for potential correlation within siblings from the same pregnancy, with adjustment for gestational age at birth and recruitment site as a fixed effect. The primary analysis included infants with complete data and excluded data from infants known to be alive but in whom neurodevelopmental outcomes were not assessed.||1.32|0.81|0.05
91728603|NCT01378273|183352945|OTHER|SAEs were defined prospectively. The rate of total SAEs observed through hospital discharge were compared after accounting for potential within-sibship correlation (with multiple gestations) using Generalized Estimating Equations (GEE) with robust standard errors. We used a GEE Wald test based on Poisson or logistic regression for total SAE count and individual events respectively. All other non-categorical data were assessed with GEE regression models appropriate for continuous outcomes.|Risk Ratio (RR)|1.01||||0.05|TWO_SIDED|95.0|0.83|1.22||Statistical significance was set at 0.05 for the efficacy analysis and for the final safety analysis comparing the rate of total SAEs between treatment groups, and 0.031 for death and 0.004 for the ten individual SAEs due to sequential monitoring.|Poisson regression|Adjusted for multiple gestation and gestational age|Epo is numerator and Control is denominator|We hypothesized that Epo would be safe, with no excess of SAEs compared to control infants. Sample size was based on the primary outcome, severe neurodevelopmental impairment or death.||1.22|0.83|0.05
91728604|NCT01378273|183352946|SUPERIORITY|||||||0.36||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.05.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For all statistical comparisons between groups, Generalized Estimating Equations (GEE) with robust standard errors and a working independence correlation structure for infants included from a multiple gestation were used. A GEE-based Wald test was used to examine differences in the global brain injury severity score between treatment groups, with adjustment for gestational age (GA) at birth used to stratify treatment randomization (24+0 to 25+6 vs. 26+0 to 27+6 in weeks+days of GA).||||0.36
91528293|NCT01946243|182931929|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.07||||0.028|TWO_SIDED|95.0|0.007|0.125|||Monte Carlo test|||Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.||0.125|0.007|0.0280
91528294|NCT01946243|182931930|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0025
91490971|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5054|TWO_SIDED|95.0|-1.93|0.97|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.97|-1.93|0.5054
91490972|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|-0.77||0.4793|TWO_SIDED|95.0|-2.1|1.01|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||1.01|-2.10|0.4793
91490973|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.66||0.4496|TWO_SIDED|95.0|-1.83|0.83|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.83|-1.83|0.4496
91490974|NCT02609828|182855053|SUPERIORITY||Difference in least square LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.77||0.1263|TWO_SIDED|95.0|-2.77|0.36|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.36|-2.77|0.1263
91490975|NCT02609828|182855053|SUPERIORITY||Difference in LS mean|-1.05|STANDARD_ERROR_OF_MEAN|0.73||0.162|TWO_SIDED|95.0|-2.54|0.44|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.44|-2.54|0.1620
91696881|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|2.383|||||TWO_SIDED|95.0|1.474|3.851||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.851|1.474|
91696882|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.202|||||TWO_SIDED|95.0|0.754|1.915||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.915|0.754|
91696883|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.12|||||TWO_SIDED|95.0|0.689|1.821||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.821|0.689|
91696884|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.576|||||TWO_SIDED|95.0|0.987|2.516||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.516|0.987|
91696885|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.504|||||TWO_SIDED|95.0|0.316|0.805||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.805|0.316|
91696886|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.47|||||TWO_SIDED|95.0|0.293|0.754||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.754|0.293|
91758866|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.114||||0.8586|TWO_SIDED|95.0|0.339|3.667||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||3.667|0.339|0.8586
91528295|NCT03377790|182932016|SUPERIORITY||||||<|0.0001||||||Differences between treatments arms are compared using a chi-square test.|Chi-squared|||||||<0.0001
91528296|NCT03377790|182932017|SUPERIORITY|||||||0.0067|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0067
91758867|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.935||||0.8478|TWO_SIDED|95.0|0.47|1.861||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||1.861|0.470|0.8478
91696887|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.662|||||TWO_SIDED|95.0|0.414|1.056||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.056|0.414|
91696888|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.932|||||TWO_SIDED|95.0|0.583|1.492||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.492|0.583|
91696889|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.312|||||TWO_SIDED|95.0|0.831|2.071||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.071|0.831|
91696890|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.407|||||TWO_SIDED|95.0|0.88|2.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.249|0.880|
91728605|NCT01378273|183352947|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.007.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For statistical inference, we utilized generalized estimating equations (GEE) with robust standard errors to appropriately account for potential correlation of biomarkers for same-birth siblings. Each respective GEE model adjusted for gestational age at birth and treatment assignment as fixed factors associated with the original study design. Biomarker levels at each follow-up time point were analysed using separate GEE models. Epo levels were log-transformed in all statistical analyses.||||<0.001
91758868|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.634||||0.2445|TWO_SIDED|95.0|0.287|1.401||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.401|0.287|0.2445
91758869|NCT00265317|183410822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.9191|TWO_SIDED|95.0|0.072|18.59||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||18.59|0.072|0.9191
91758870|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121||||0.8563|TWO_SIDED|95.0|0.326|3.847||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||3.847|0.326|0.8563
91758871|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.7375|TWO_SIDED|95.0|0.599|2.064||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/A||2.064|0.599|0.7375
91758872|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.8066|TWO_SIDED|95.0|0.375|2.147||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs234060 Genotype: A/A||2.147|0.375|0.8066
91758873|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.6945|TWO_SIDED|95.0|0.449|1.708||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.708|0.449|0.6945
91758874|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.8536|TWO_SIDED|95.0|0.536|2.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||2.122|0.536|0.8536
91758875|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.732||||0.3657|TWO_SIDED|95.0|0.283|26.42||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: T/T||26.42|0.283|0.3657
91758876|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.4657|TWO_SIDED|95.0|0.424|1.483||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.483|0.424|0.4657
91758877|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.364||||0.4168|TWO_SIDED|95.0|0.641|2.9||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/A||2.900|0.641|0.4168
91758878|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.908||||0.7836|TWO_SIDED|95.0|0.456|1.809||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.809|0.456|0.7836
91758879|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.8531|TWO_SIDED|95.0|0.472|1.863||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.863|0.472|0.8531
91758880|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32||||0.3272|TWO_SIDED|95.0|0.412|13.07||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.07|0.412|0.3272
91758881|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.963|TWO_SIDED|95.0|0.491|1.972||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||1.972|0.491|0.9630
91758882|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.227||||0.6003|TWO_SIDED|95.0|0.567|2.656||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||2.656|0.567|0.6003
91758883|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.6703|TWO_SIDED|95.0|0.229|2.58||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||2.580|0.229|0.6703
91758884|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.106||||0.81|TWO_SIDED|95.0|0.485|2.525||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||2.525|0.485|0.8100
91490976|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0575|TWO_SIDED|95.0|-2.17|0.04|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.04|-2.17|0.0575
91696891|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|5.428|||||TWO_SIDED|95.0|4.0|7.365||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||7.365|4|
91696892|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.091|||||TWO_SIDED|95.0|0.804|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.804|
91758885|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.076||||0.8335|TWO_SIDED|95.0|0.541|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.141|0.541|0.8335
91758886|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.598|TWO_SIDED|95.0|0.268|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||2.141|0.268|0.5980
91758887|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.9287|TWO_SIDED|95.0|0.487|2.199||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||2.199|0.487|0.9287
91758888|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.053||||0.8842|TWO_SIDED|95.0|0.526|2.106||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.106|0.526|0.8842
91758889|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||4.028|0.316|0.8501
91758890|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.229||||0.4118|TWO_SIDED|95.0|0.749|2.017||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||2.017|0.749|0.4118
91758891|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.286||||0.1299|TWO_SIDED|95.0|0.051|1.596||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||1.596|0.051|0.1299
91758892|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.1859|TWO_SIDED|95.0|0.399|1.2||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.200|0.399|0.1859
91758893|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.672||||0.0091|TWO_SIDED|95.0|1.291|10.44||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||10.44|1.291|0.0091
91758894|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.652|0.654|0.8708
91758895|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9888|TWO_SIDED|95.0|0.59|1.681||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.681|0.590|0.9888
91758896|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9702|TWO_SIDED|95.0|0.36|2.891||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.891|0.360|0.9702
91758897|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9419|TWO_SIDED|95.0|0.466|2.032||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/C||2.032|0.466|0.9419
91758898|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.7677|TWO_SIDED|95.0|0.549|2.252||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.252|0.549|0.7677
91758899|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: T/T||4.028|0.316|0.8501
91758900|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5233|TWO_SIDED|95.0|0.322|1.782||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.782|0.322|0.5233
91758901|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.75|TWO_SIDED|95.0|0.549|2.297||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.297|0.549|0.7500
91758902|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.6614|TWO_SIDED|95.0|0.483|3.142||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||3.142|0.483|0.6614
91758903|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.779||||0.2552|TWO_SIDED|95.0|0.652|4.855||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||4.855|0.652|0.2552
91758904|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.088||||0.7931|TWO_SIDED|95.0|0.577|2.052||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||2.052|0.577|0.7931
91758905|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.449||||0.1365|TWO_SIDED|95.0|0.152|1.331||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.331|0.152|0.1365
91758906|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.5544|TWO_SIDED|95.0|0.504|1.447||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.447|0.504|0.5544
91758907|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.721||||0.3132|TWO_SIDED|95.0|0.59|5.021||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||5.021|0.590|0.3132
91758908|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.263||||0.3698|TWO_SIDED|95.0|0.755|2.113||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||2.113|0.755|0.3698
91728606|NCT04128228|183352985|OTHER|"Single group: All individuals with alcohol use disorder received the same treatment.~Brain responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT)."|F value for the 2 X 2 Group Interaction|5.5|||<|0.05|TWO_SIDED|||||A 2 × 2 × 3 Linear Mixed Model was conducted with Early Trauma Group (ET, NT) and Drinking Group (AUD, MD) as between-subjects factors, and Condition (stress, alcohol, neutral) as the within-subjects factor.|Linear Mixed Model|||A regions of interest (ROI) analysis was conducted to evaluate brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas in the BioImage Suite application, from which the beta value for the VmPFC ROI was obtained for a Linear Mixed Model analysis.||||<0.05
91728607|NCT04128228|183352986|OTHER|Single group (all individuals with alcohol use disorder received the same treatment). Hormone responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT).|F value|4.79|||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
91728608|NCT04128228|183352987|OTHER|Single Group|Hazard Ratio (HR)|0.71|||<|0.05|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||||.95|.53|<0.05
91728609|NCT04128228|183352988|OTHER|Single Group. All individuals with alcohol use disorder received the same treatment.|t value|-3.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91728610|NCT04128228|183352989|OTHER|Single Group (All individuals with alcohol use disorder received the same treatment.)|t value|-2.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91490977|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-1.96|STANDARD_ERROR_OF_MEAN|0.62||0.0031|TWO_SIDED|95.0|-3.22|-0.7|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.70|-3.22|0.0031
91490978|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-1.44|STANDARD_ERROR_OF_MEAN|0.68||0.041|TWO_SIDED|95.0|-2.82|-0.06|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.06|-2.82|0.0410
91728611|NCT01117350|183352990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54||||0.439|TWO_SIDED|95.0|-3.88|8.93||"If superiority not demonstrated, switching from superiority to non-inferiority considered.~Conclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine - liraglutide) \> or = to - 3.5%"|Chi-squared|||"Superiority testing~H0: Rate measured with insulin glargine = rate measured with liraglutide~H1: Rate measured with insulin glargine ≠ rate measured with liraglutide~Sample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%."||8.93|-3.88|0.439
91728612|NCT01064622|183353035|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.15|TWO_SIDED|95.0|0.55|1.22||Reported p-value is one-sided. p\<0.10 required for statistical significance.|Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.22|0.55|0.15
91728613|NCT01064622|183353036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.37|TWO_SIDED|95.0|0.64|1.46|||Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.46|0.64|0.37
91490979|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.77||0.2598|TWO_SIDED|95.0|-2.44|0.68|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.68|-2.44|0.2598
91728614|NCT01064622|183353037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|TWO_SIDED|||||Two-sided p-value for Cochran-Mantel-Haenszel test stratified by Karnofsky performance status and disease status.|Cochran-Mantel-Haenszel|||||||0.42
91728615|NCT05330429|183353045|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.9323|TWO_SIDED|95.0|0.339|2.691|||Unstratified Log-rank Test|2-Sided P-value was based on unstratified log-rank test.|Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||2.691|0.339|0.9323
91728616|NCT05330429|183353048|SUPERIORITY||Hazard Ratio (HR)|0.299|||||TWO_SIDED|95.0|0.056|1.6|||||Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||1.600|0.056|
91728617|NCT02931539|183353058|SUPERIORITY||Difference in percentage of responders|32.8|||<|0.001|TWO_SIDED|95.0|22.8|42.74|||Cochran-Mantel-Haenszel|||||42.74|22.80|<0.001
91728618|NCT02931539|183353059|SUPERIORITY||Difference in percentage of responders|9.5||||0.013|TWO_SIDED|95.0|2.02|16.88|||Cochran-Mantel-Haenszel|||||16.88|2.02|0.013
91728619|NCT02931539|183353074|OTHER||Hazard Ratio (HR)|1.14||||0.647|TWO_SIDED|95.0|0.549|2.357|||Log Rank|Two-sided p-value comparing treatment groups was calculated from the log rank test by Kaplan-Meier Method.|Stratified Cox regression model was used as transplant type and baseline plasma CMV DNA level as stratification factors.|||2.357|0.549|0.647
91728620|NCT02059642|183353084|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1||||0.1358|TWO_SIDED|95.0|-4.87|0.66|||Mixed Models Analysis|MMRM: Model of Repeated Measures||||0.66|-4.87|0.1358
91728621|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.155|||||TWO_SIDED|97.5|1.086|1.229||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.229|1.086|
91728622|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>1.|GMR|1.155|||||TWO_SIDED|95.0|1.094|1.22||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.220|1.094|
91728623|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.063|||||TWO_SIDED|97.5|0.999|1.13||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.130|0.999|
91728624|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.063|||||TWO_SIDED|95.0|1.007|1.122||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.122|1.007|
91728625|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.414|||||TWO_SIDED|97.5|1.322|1.513||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.513|1.322|
91728626|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.414|||||TWO_SIDED|95.0|1.333|1.5||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.500|1.333|
91490980|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-0.77|STANDARD_ERROR_OF_MEAN|0.8||0.3426|TWO_SIDED|95.0|-2.38|0.85|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.85|-2.38|0.3426
91528297|NCT03377790|182932018|SUPERIORITY|||||||0.0152|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0152
91728627|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.38|||||TWO_SIDED|97.5|1.3|1.465||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.465|1.300|
91728628|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.38|||||TWO_SIDED|95.0|1.31|1.454||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.454|1.310|
91728629|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.118|||||TWO_SIDED|97.5|1.063|1.175||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.175|1.063|
91728630|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.118|||||TWO_SIDED|95.0|1.07|1.167||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.167|1.070|
91728631|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.007|||||TWO_SIDED|97.5|0.969|1.047||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.047|0.969|
91758909|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.411||||0.1495|TWO_SIDED|95.0|0.119|1.423||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||1.423|0.119|0.1495
91758910|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.1911|TWO_SIDED|95.0|0.781|3.332||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||3.332|0.781|0.1911
91758911|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.5259|TWO_SIDED|95.0|0.384|1.636||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||1.636|0.384|0.5259
91758912|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.331||||0.0996|TWO_SIDED|95.0|0.082|1.339||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||1.339|0.082|0.0996
91696893|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.759|||||TWO_SIDED|95.0|0.559|1.031||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.031|0.559|
91728632|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.007|||||TWO_SIDED|95.0|0.973|1.042||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.042|0.973|
91728633|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.216|||||TWO_SIDED|97.5|1.156|1.278||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.278|1.156|
91490981|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-1.2|STANDARD_ERROR_OF_MEAN|0.72||0.1034|TWO_SIDED|95.0|-2.65|0.26|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.26|-2.65|0.1034
91490982|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-1.91|STANDARD_ERROR_OF_MEAN|0.84||0.029|TWO_SIDED|95.0|-3.6|-0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.21|-3.60|0.0290
91528298|NCT03377790|182932019|SUPERIORITY|||||||0.0302|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0302
91528299|NCT03377790|182932020|SUPERIORITY|||||||0.5921|||||||ANCOVA|Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.||||||0.5921
91728634|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.216|||||TWO_SIDED|95.0|1.163|1.27||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.270|1.163|
91728635|NCT06097273|183353086|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.154|||||TWO_SIDED|97.5|1.109|1.201||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.201|1.109|
91728636|NCT06097273|183353086|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.154|||||TWO_SIDED|95.0|1.115|1.195||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.195|1.115|
91728637|NCT06097273|183353087|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.641|||||TWO_SIDED|95.0|1.526|1.765||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.765|1.526|
91728638|NCT06097273|183353087|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.641|||||TWO_SIDED|97.5|1.51|1.783||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.783|1.510|
91728639|NCT06097273|183353087|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.308|||||TWO_SIDED|95.0|1.219|1.404||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.404|1.219|
91728640|NCT06097273|183353087|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.308|||||TWO_SIDED|97.5|1.207|1.418||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.418|1.207|
91728641|NCT06097273|183353088|SUPERIORITY|The superiority in seroconversion rate (SCR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.4|8.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.4|2.4|
91728642|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|5.4|||||TWO_SIDED|97.5|1.9|8.8||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.8|1.9|
91728643|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.0|||||TWO_SIDED|95.0|1.0|7.1||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.1|1.0|
91728644|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.0|||||TWO_SIDED|97.5|0.5|7.6||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.6|0.5|
91728645|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.9|7.2||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.2|1.9|
91728646|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.5|7.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.5|1.5|
91490983|NCT02609828|182855054|SUPERIORITY||Difference in LS mean|-1.62|STANDARD_ERROR_OF_MEAN|0.83||0.06|TWO_SIDED|95.0|-3.31|0.07|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.07|-3.31|0.0600
91490984|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8054|TWO_SIDED|95.0|0.41|3.18|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.18|0.41|0.8054
91490985|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9292|TWO_SIDED|95.0|0.22|3.98|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.98|0.22|0.9292
91696894|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.499|||||TWO_SIDED|95.0|2.577|4.751||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.751|2.577|
91696895|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.982|||||TWO_SIDED|95.0|0.722|1.334||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.334|0.722|
91696896|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.699|||||TWO_SIDED|95.0|0.513|0.95||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.95|0.513|
91696897|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.513|||||TWO_SIDED|95.0|1.846|3.421||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.421|1.846|
91696898|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.201|||||TWO_SIDED|95.0|0.149|0.272||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.272|0.149|
91696899|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.14|||||TWO_SIDED|95.0|0.103|0.189||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.189|0.103|
91696900|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.645|||||TWO_SIDED|95.0|0.476|0.873||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.873|0.476|
91696901|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.181|||||TWO_SIDED|95.0|0.134|0.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.245|0.134|
91728647|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-3.3|0.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.4|-3.3|
91758913|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.2755|TWO_SIDED|95.0|0.45|1.259||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.259|0.450|0.2755
91696902|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.129|||||TWO_SIDED|95.0|0.095|0.174||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.174|0.095|
91696903|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric Mean Ratio at day 29|0.463|||||TWO_SIDED|95.0|0.341|0.628||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.628|0.341|
91696904|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.696|||||TWO_SIDED|95.0|0.514|0.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.943|0.514|
91696905|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.207|||||TWO_SIDED|95.0|2.368|4.343||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.343|2.368|
91696906|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.9|||||TWO_SIDED|95.0|0.665|1.218||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.218|0.665|
91696907|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.64|||||TWO_SIDED|95.0|0.472|0.868||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.868|0.472|
91696908|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.303|||||TWO_SIDED|95.0|1.7|3.121||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.121|1.7|
91696909|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|4.608|||||TWO_SIDED|95.0|3.398|6.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.249|3.398|
91696910|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.293|||||TWO_SIDED|95.0|0.954|1.753||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.753|0.954|
91696911|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.92|||||TWO_SIDED|95.0|0.677|1.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.249|0.677|
91728648|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|-1.4|||||TWO_SIDED|97.5|-3.6|0.7||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.7|-3.6|
91758914|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.85||||0.012|TWO_SIDED|95.0|1.253|18.78||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||18.78|1.253|0.0120
91728649|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|17.9|||||TWO_SIDED|95.0|14.8|21.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.0|14.8|
91490986|NCT02609828|182855057|SUPERIORITY|||||||0.9565|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9565
91728650|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|17.9|||||TWO_SIDED|97.5|14.3|21.4||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.4|14.3|
91728651|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|14.6|||||TWO_SIDED|95.0|11.6|17.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||17.6|11.6|
91728652|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|14.6|||||TWO_SIDED|97.5|11.1|18.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||18.0|11.1|
91728653|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|8.6|||||TWO_SIDED|95.0|6.0|11.2||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.2|6.0|
91728654|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|8.6|||||TWO_SIDED|97.5|5.6|11.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.6|5.6|
91728655|NCT06097273|183353088|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|2.7|||||TWO_SIDED|95.0|0.6|4.7||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||4.7|0.6|
91728656|NCT06097273|183353088|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|2.7|||||TWO_SIDED|97.5|0.3|5.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||5.0|0.3|
91728657|NCT06097273|183353089|SUPERIORITY|The superiority in seroresponse rate (SRR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|12.8|||||TWO_SIDED|95.0|10.0|15.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.5|10.0|
91728658|NCT06097273|183353089|NON_INFERIORITY|The noninferiority in SRR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|12.8|||||TWO_SIDED|97.5|9.6|15.9||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.9|9.6|
91728659|NCT06097273|183353089|SUPERIORITY|The superiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|8.1|||||TWO_SIDED|95.0|5.5|10.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||10.6|5.5|
91728660|NCT06097273|183353089|NON_INFERIORITY|The noninferiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|8.1|||||TWO_SIDED|97.5|5.2|11.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||11.0|5.2|
91490987|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.88||||0.1429|TWO_SIDED|95.0|0.81|4.36|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.36|0.81|0.1429
91728661|NCT04359680|183353118|SUPERIORITY||Odds Ratio (OR)|1.029||||0.9434|TWO_SIDED|95.0|0.4696|2.2546|||Cochran-Mantel-Haenszel|||||2.2546|0.4696|0.9434
91728662|NCT04359680|183353119|SUPERIORITY||Odds Ratio (OR)|1.1162||||0.6805|TWO_SIDED|95.0|0.6623|1.8813|||Cochran-Mantel-Haenszel|||||1.8813|0.6623|0.6805
91728663|NCT04359680|183353121|SUPERIORITY|||||||0.3459|||||||Cochran-Mantel-Haenszel|||||||0.3459
91728664|NCT02722330|183353130|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
91728665|NCT02722330|183353131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Ease of communication||||<0.0001
91728666|NCT02722330|183353131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Reverberation||||<0.0001
91728667|NCT02722330|183353131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Background noise||||<0.0001
91696912|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.31|||||TWO_SIDED|95.0|2.436|4.496||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.496|2.436|
91696913|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.281|||||TWO_SIDED|95.0|0.207|0.38||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.38|0.207|
91728668|NCT02722330|183353131|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon Signed rank Test|||Aversiveness||||0.0004
91696914|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.2|||||TWO_SIDED|95.0|0.147|0.271||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.271|0.147|
91696915|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.718|||||TWO_SIDED|95.0|0.529|0.975||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.975|0.529|
91696916|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.712|||||TWO_SIDED|95.0|0.524|0.966||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.966|0.524|
91696917|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.56|||||TWO_SIDED|95.0|1.886|3.474||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.474|1.886|
91696918|NCT00972816|183287620|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.597|||||TWO_SIDED|95.0|2.646|4.89||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.89|2.646|
91728669|NCT02722330|183353131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Global score||||<0.0001
91728670|NCT02722330|183353132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech scale||||<0.0001
91728671|NCT02722330|183353132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Spatial scale||||<0.0001
91728672|NCT02722330|183353132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Qualities scale||||<0.0001
91728673|NCT02722330|183353133|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
91728674|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
91728675|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
91728676|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
91728677|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
91728678|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
91728679|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
91728680|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
91728681|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
91728682|NCT02722330|183353134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
91728683|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
91728684|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
91728685|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
91728686|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
91728687|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
91490988|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|5.19||||0.014||95.0|1.4|19.31|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.31|1.40|0.0140
91490989|NCT02609828|182855057|SUPERIORITY|||||||0.945|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9450
91696919|NCT03806933|183287628|OTHER||Hazard Ratio (HR)|1.03|||=|0.881|TWO_SIDED|95.0|0.7|1.51||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||Hazard ratio (HR) was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.51|0.7|= 0.881
91696920|NCT03806933|183287628|OTHER||Hazard Ratio (HR)|0.72|||=|0.089|TWO_SIDED|95.0|0.49|1.05||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.05|0.49|= 0.089
91696921|NCT03806933|183287628|OTHER||Hazard Ratio (HR)|0.56||||0.0035|TWO_SIDED|95.0|0.38|0.83|||Wald Chi-square test|P-values were based on Wald Chi-Square tests for hazard ratios.|HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||0.83|0.38|0.0035
91528300|NCT03377790|182932021|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
91696922|NCT05088603|183287640|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
91696923|NCT05088603|183287641|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91696924|NCT05088603|183287642|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91696925|NCT05088603|183287644|SUPERIORITY|||||||0.529|||||||Fisher Exact|||||||0.529
91696926|NCT05088603|183287645|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91696927|NCT05088603|183287646|SUPERIORITY|||||||0.502|||||||Fisher Exact|||||||0.502
91696928|NCT05088603|183287647|SUPERIORITY|||||||0.431|||||||Fisher Exact|||||||0.431
91696929|NCT05088603|183287648|SUPERIORITY|||||||0.434|||||||Fisher Exact|||||||0.434
91696930|NCT05088603|183287649|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
91696931|NCT05088603|183287650|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||0.051
91696932|NCT02162719|183287661|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.6||||0.0372|TWO_SIDED|90.0|0.4|0.91||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||0.91|0.40|0.0372
91696933|NCT02162719|183287662|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.59||||0.1753|TWO_SIDED|90.0|0.3|1.16||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.16|0.30|0.1753
91728688|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
91728689|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
91728690|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
91696934|NCT02162719|183287663|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|0.76||||0.3636|TWO_SIDED|90.0|0.46|1.27|||Log Rank|||||1.27|0.46|0.3636
91728691|NCT02722330|183353135|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
91728692|NCT02722330|183353136|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon Signed Rank test|||||||0.002
91728693|NCT02722330|183353137|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon Signed Rank test|||||||0.0024
91728694|NCT02722330|183353138|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 50 dB||||<0.0001
91728695|NCT02722330|183353138|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
91728696|NCT02722330|183353138|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
91728697|NCT02722330|183353139|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All variable had the same p value (\<0.0001).|Wolcoxon Signed rank test|||Speech Presentation Level 50 dB||||<0.0001
91728698|NCT02722330|183353139|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
91728699|NCT02722330|183353139|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
91728700|NCT02722330|183353140|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Rank test|||||||0.036
91728701|NCT02722330|183353141|SUPERIORITY_OR_OTHER|||||||0.065|||||||Wilcoxon Signed Rank test|||||||0.065
91728702|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon Signed Rank test|||250 Hz||||0.47
91728703|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||500 Hz||||0.16
91728704|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon Signed Rank test|||750 Hz||||0.59
91728705|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.034|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.034
91728706|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.25
91728707|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.023
91728708|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.028
91490990|NCT02609828|182855057|SUPERIORITY|||||||0.9489|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9489
91490991|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1932|TWO_SIDED|95.0|0.78|3.39|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.39|0.78|0.1932
91490992|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0254|TWO_SIDED|95.0|1.15|8.74|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.74|1.15|0.0254
91490993|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0455|TWO_SIDED|95.0|1.03|24.16|||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||24.16|1.03|0.0455
91490994|NCT02609828|182855057|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
91490995|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0969|TWO_SIDED|95.0|0.9|3.72|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.72|0.90|0.0969
91490996|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0043|TWO_SIDED|95.0|1.58|11.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||11.74|1.58|0.0043
91696935|NCT02162719|183287664|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.8||||0.3607|TWO_SIDED|95.0|0.5|1.28||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.28|0.50|0.3607
91696936|NCT02162719|183287665|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.73||||0.4422|TWO_SIDED|95.0|0.32|1.65||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.65|0.32|0.4422
91696937|NCT02162719|183287666|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|1.13||||0.7599|TWO_SIDED|95.0|0.52|2.47|||Log Rank|||||2.47|0.52|0.7599
91490997|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|5.49||||0.0352|TWO_SIDED|95.0|1.13|26.75|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||26.75|1.13|0.0352
91490998|NCT02609828|182855057|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
91528301|NCT03377790|182932022|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
91490999|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1471|TWO_SIDED|95.0|0.83|3.52|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.52|0.83|0.1471
91491000|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0405|TWO_SIDED|95.0|1.04|6.22|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.22|1.04|0.0405
91491001|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0993|TWO_SIDED|95.0|0.8|12.83|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||12.83|0.80|0.0993
91491002|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1726|TWO_SIDED|95.0|0.51|43.64|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||43.64|0.51|0.1726
91491003|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0918|TWO_SIDED|95.0|0.91|3.74|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.74|0.91|0.0918
91528302|NCT03377790|182932023|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
91528303|NCT03377790|182932024|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
91696938|NCT03854370|183287705|SUPERIORITY|||||||0.23|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub.||||0.23
91696939|NCT03854370|183287705|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.31
91696940|NCT03854370|183287705|SUPERIORITY|||||||0.35|||||||Fisher Exact|||Comparison of Chlorhexidine versus iodine post surgical scrub||||.35
91696941|NCT03854370|183287705|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of chloroxynel versus iodine post surgical scrub||||.61
91696942|NCT03854370|183287706|SUPERIORITY|||||||0.59|||||||Chi-squared|||comparison of all four groups prior to surgical scrub||||.59
91696943|NCT03854370|183287706|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||.05
91696944|NCT03854370|183287706|SUPERIORITY|||||||0.13|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine post surgical scrub||||.13
91696945|NCT03854370|183287706|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
91696946|NCT03854370|183287707|SUPERIORITY|||||||0.45|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub||||0.45
91696947|NCT03854370|183287707|SUPERIORITY|||||||0.99||||||all groups were negative for cultures|Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.99
91696948|NCT03854370|183287707|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chlorhexidine versus iodine at post surgical scrub||||0.99
91696949|NCT03854370|183287707|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
91728709|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.0075
91728710|NCT02722330|183353142|SUPERIORITY_OR_OTHER|||||||0.0035|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.0035
91728711|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon Signed Rank test|||250 Hz||||0.12
91728712|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.072|||||||Wilcoxon Signed Rank test|||500 Hz||||0.072
91728713|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.56|||||||Wilcoxon Signed Rank test|||750 Hz||||0.56
91728714|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.16
91728715|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.39
91728716|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.11
91728717|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.38
91728718|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.014|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.014
91528304|NCT03377790|182932025|SUPERIORITY|||||||0.052|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0520
91696950|NCT03854370|183287708|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.61
91696951|NCT03854370|183287708|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
91696952|NCT03854370|183287708|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
91696953|NCT03854370|183287709|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.32
91728719|NCT02722330|183353143|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.71
91728720|NCT02722330|183353144|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon Signed Rank test|||||||0.48
91728721|NCT02722330|183353145|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||||||0.11
91696954|NCT03854370|183287709|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
91696955|NCT03854370|183287709|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.50
91696956|NCT03854370|183287710|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.99
91696957|NCT03854370|183287710|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||comparison of chlorhexidine versus iodine at post procedure||||0.99
91696958|NCT03854370|183287710|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
91696959|NCT00394836|183287732|SUPERIORITY_OR_OTHER||percentage of responders|13.0|||||TWO_SIDED|95.0|4.0|31.0|||||Response rate is calculated as the number of responses divided by the number of participants treated \* 100.|||31|4|
91728722|NCT02722330|183353146|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.017
91728723|NCT02722330|183353146|SUPERIORITY_OR_OTHER|||||||0.095|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||0.095
91728724|NCT02722330|183353146|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.57
91728725|NCT02722330|183353147|SUPERIORITY_OR_OTHER|||||||0.096|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.096
91728726|NCT02722330|183353147|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||1.00
91728727|NCT02722330|183353147|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.41
91728728|NCT01755156|183353153|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.55|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-0.34|-0.75|<0.001
91728729|NCT01755156|183353154|SUPERIORITY_OR_OTHER||Difference in %|0.5|||||TWO_SIDED|95.0|-8.8|9.8|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||9.8|-8.8|
91728730|NCT01755156|183353155|SUPERIORITY_OR_OTHER||Difference in %|-2.5|||||TWO_SIDED|95.0|-6.6|1.1|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||1.1|-6.6|
91728731|NCT01755156|183353156|SUPERIORITY_OR_OTHER||Difference in %|4.5|||||TWO_SIDED|95.0|-3.3|12.3||||||||12.3|-3.3|
91728732|NCT01755156|183353157|SUPERIORITY_OR_OTHER||Difference in %|-14.5||||0.011|TWO_SIDED|95.0|-25.6|-3.4|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-3.4|-25.6|0.011
91728733|NCT01755156|183353158|SUPERIORITY_OR_OTHER||Difference in least squares means|-9.5||||0.01|TWO_SIDED|95.0|-16.7|-2.3|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-2.3|-16.7|0.010
91728734|NCT01755156|183353161|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|19.2|||<|0.001|TWO_SIDED|95.0|10.1|28.0|||Miettinen & Nurminen method|||||28.0|10.1|<0.001
91728735|NCT01755156|183353162|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|4.2||||0.164|TWO_SIDED|95.0|-1.8|10.5|||Miettinen & Nurminen method|||||10.5|-1.8|0.164
91728736|NCT01755156|183353165|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.8||||0.001|TWO_SIDED|95.0|-44.8|-10.8|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-10.8|-44.8|0.001
91696960|NCT00394836|183287732|SUPERIORITY_OR_OTHER||percentage of responders|10.0|||||TWO_SIDED|95.0|5.0|19.0||||||||19|5|
91696961|NCT03692325|183287751|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91696962|NCT01560234|183287784|SUPERIORITY_OR_OTHER||Slope|0.81|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.63|1.0|||Regression, Linear||AUC (nmol\*h/L) 5 to 30 μg|||1.00|0.63|
91696963|NCT01560234|183287785|SUPERIORITY_OR_OTHER||Slope|0.84|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.65|1.04|||Regression, Linear||AUC(0-t) (nmol\*h/L) 5 to 30 μg|||1.04|0.65|
91696964|NCT01560234|183287786|SUPERIORITY_OR_OTHER||Slope|0.95|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|0.87|1.04|||Regression, Linear||Cmax (nmol/L) 0.5 to 30 μg|||1.04|0.87|
91696965|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|99.75|||||TWO_SIDED|95.0|65.76|151.32|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Plasma||151.32|65.76|
91696966|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|92.99|||||TWO_SIDED|95.0|61.21|141.27|||ANCOVA||Cohort 2/1.5ug vs Placebo|24 hour Plasma||141.27|61.21|
91696967|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|145.83|||||TWO_SIDED|95.0|96.11|221.28|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Plasma||221.28|96.11|
91696968|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|106.23|||||TWO_SIDED|95.0|66.42|169.93|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Plasma||169.93|66.42|
91696969|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|223.76||||||95.0|144.98|345.35|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour plasma||345.35|144.98|
91696970|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|228.23|||||TWO_SIDED|95.0|150.36|346.41|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour plasma||346.41|150.36|
91696971|NCT01560234|183287787|SUPERIORITY_OR_OTHER||Percentage of Placebo|684.03|||||TWO_SIDED|95.0|495.31|944.65|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour plasma||944.65|495.31|
91696972|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|95.81|||||TWO_SIDED|95.0|72.7|126.28|||ANCOVA||Cohort 1/0.15 ug vs Placebo|48 hour plasma||126.28|72.70|
91696973|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|91.72|||||TWO_SIDED|95.0|69.53|121.0|||ANCOVA||Cohort 2/0.5 ug vs Placebo|48 hour plasma||121.00|69.53|
91696974|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|112.34|||||TWO_SIDED|95.0|82.3|153.35|||ANCOVA||Cohort 3/1.5 ug vs Placebo|48 hour Plasma||153.35|82.30|
91696975|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|120.0|||||TWO_SIDED|95.0|91.04|158.18|||ANCOVA||Cohort 4/5 ug vs Placebo|48 hour plasma||158.18|91.04|
91696976|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|102.67|||||TWO_SIDED|95.0|77.02|136.87|||ANCOVA||Cohort 5/15 ug vs Placebo|48 hour placebo||136.87|77.02|
91696977|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|146.86|||||TWO_SIDED|95.0|111.39|193.62|||ANCOVA||Cohort 7/15 ug vs Placebo|48 hour plasma||193.62|111.39|
91696978|NCT01560234|183287788|SUPERIORITY_OR_OTHER||Percentage of Placebo|240.04|||||TWO_SIDED|95.0|193.82|297.28|||ANCOVA||Cohort 6 and 8/30 ug|48 hour plasma||297.28|193.82|
91696979|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|114.87|||||TWO_SIDED|95.0|34.83|378.78|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Sputum||378.78|34.83|
91696980|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.89|||||TWO_SIDED|95.0|24.96|268.7|||ANCOVA||Cohort 2/0.5 ug vs Placebo|24 hour Sputum||268.70|24.96|
91696981|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.55|||||TWO_SIDED|95.0|20.63|322.42|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Sputum||322.42|20.63|
91696982|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|304.37|||||TWO_SIDED|95.0|76.61|1209.33|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Sputum||1209.33|76.61|
91696983|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|193.8|||||TWO_SIDED|95.0|59.01|636.49|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour Sputum||636.49|59.01|
91696984|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|467.96|||||TWO_SIDED|95.0|142.77|1533.92|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour Sputum||1533.92|142.77|
91696985|NCT01560234|183287790|SUPERIORITY_OR_OTHER||Comparison of Placebo|1087.35|||||TWO_SIDED|95.0|317.19|3727.57|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour Sputum||3727.57|317.19|
91696986|NCT02028767|183287791|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.57|STANDARD_ERROR_OF_MEAN|1.024||0|TWO_SIDED|90.0|94.662|102.639||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.639|94.662|0.0000
91696987|NCT02028767|183287791|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.71|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.783|102.796||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.796|94.783|<0.0001
91696988|NCT02028767|183287792|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.93|STANDARD_ERROR_OF_MEAN|1.019||0|TWO_SIDED|90.0|95.856|102.107||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.107|95.856|0.0000
91728737|NCT01755156|183353166|SUPERIORITY_OR_OTHER||Difference in least squares means|3.7||||0.025|TWO_SIDED|95.0|0.5|6.9|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||6.9|0.5|0.025
91728738|NCT01755156|183353168|SUPERIORITY_OR_OTHER||Kaplan-Meier difference %|-1.2||||0.654|TWO_SIDED|95.0|-7.0|4.7|||Log Rank|||||4.7|-7.0|0.654
91728739|NCT03142451|183353172|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|0.749||0.0031|TWO_SIDED|95.0|0.75|3.68|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, baseline inflammatory lesion count, and analysis center.||||3.68|0.75|0.0031
91528305|NCT02564055|182932057|OTHER||Difference in percentages|22.6|||||TWO_SIDED|95.0|-2.4|45.5|||||Difference between GSK2894512 1 percent BID and Vehicle BID has been presented.|||45.5|-2.4|
91491004|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0704|TWO_SIDED|95.0|0.94|4.82|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.82|0.94|0.0704
91491005|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3569|TWO_SIDED|95.0|0.56|5.01|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.01|0.56|0.3569
91491006|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|2.46||||0.3062|TWO_SIDED|95.0|0.44|13.79|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.79|0.44|0.3062
91491007|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1058|TWO_SIDED|95.0|0.88|3.85|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.85|0.88|0.1058
91491008|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.81||||0.1571|TWO_SIDED|95.0|0.79|4.14|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.14|0.79|0.1571
91491009|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2454|TWO_SIDED|95.0|0.65|5.24|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.24|0.65|0.2454
91528306|NCT02564055|182932057|OTHER||Difference in percentages|7.4|||||TWO_SIDED|95.0|-18.3|32.0|||||Difference between GSK2894512 1 percent QD and Vehicle QD has been presented.|||32.0|-18.3|
91696989|NCT02028767|183287792|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.96|STANDARD_ERROR_OF_MEAN|1.019|<|0.0001|TWO_SIDED|90.0|95.877|102.15||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.150|95.877|<0.0001
91491010|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8867|TWO_SIDED|95.0|0.24|3.46|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.46|0.24|0.8867
91491011|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0689|TWO_SIDED|95.0|0.95|4.21|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.21|0.95|0.0689
91728740|NCT03142451|183353173|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0273|TWO_SIDED|95.0|1.022|1.434||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.434|1.022|0.0273
91491012|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0568|TWO_SIDED|95.0|0.98|5.44|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.44|0.98|0.0568
91491013|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1268|TWO_SIDED|95.0|0.78|7.46|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.46|0.78|0.1268
91491014|NCT02609828|182855057|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7971|TWO_SIDED|95.0|0.25|6.0|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.00|0.25|0.7971
91528307|NCT02564055|182932057|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-11.2|38.7|||||Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented.|||38.7|-11.2|
91528308|NCT02564055|182932057|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-29.3|21.6|||||Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented.|||21.6|-29.3|
91528309|NCT02564055|182932065|OTHER||Difference in percentages|21.1|||||TWO_SIDED|95.0|-2.7|43.1|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||43.1|-2.7|
91528310|NCT02564055|182932065|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|3.3|47.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||47.5|3.3|
91528311|NCT02564055|182932065|OTHER||Difference in percentages|2.3|||||TWO_SIDED|95.0|-19.5|24.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 1 has been presented.|||24.5|-19.5|
91728741|NCT03142451|183353174|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0171|TWO_SIDED|95.0|1.028|1.425||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.425|1.028|0.0171
91491015|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6658|TWO_SIDED|95.0|0.43|3.7|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.70|0.43|0.6658
91696990|NCT02028767|183287793|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.28|STANDARD_ERROR_OF_MEAN|1.023||0|TWO_SIDED|90.0|94.549|102.156||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.156|94.549|0.0000
91728742|NCT03142451|183353175|SUPERIORITY||Mean Difference (Final Values)|7.62|STANDARD_ERROR_OF_MEAN|2.626||0.0039|TWO_SIDED|95.0|2.46|12.77|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||12.77|2.46|0.0039
91528312|NCT02564055|182932065|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-14.5|32.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||32.0|-14.5|
91528313|NCT02564055|182932065|OTHER||Difference in percentages|23.1|||||TWO_SIDED|95.0|-0.3|44.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||44.6|-0.3|
91696991|NCT02028767|183287793|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.35|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.603|102.252|||ANOVA|The p-value relates to the null hypothesis of non-equivalence.|"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.252|94.603|<0.0001
91696992|NCT00083759|183287804|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||Cochran-Mantel-Haenszel|||||||0.089
91696993|NCT00083759|183287805|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Cochran-Mantel-Haenszel|||||||0.171
91696994|NCT00083759|183287806|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Cochran-Mantel-Haenszel|||||||0.526
91696995|NCT03567005|183287820|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).|Least Squares Mean (LSM) Difference|0.0|STANDARD_ERROR_OF_MEAN|0.008|||ONE_SIDED|95.0||0.02||||||||0.02||
91696996|NCT03567005|183287821|NON_INFERIORITY|The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15|||ONE_SIDED|95.0|-0.3||||||||||-0.3|
91696997|NCT05338502|183287860|SUPERIORITY||Geometric Least Squares Mean (LSM) Ratio|0.9|||||TWO_SIDED|90.0|0.797|1.02|||ANOVA|||Fasted State||1.02|0.797|
91696998|NCT05338502|183287860|SUPERIORITY||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.876|1.12|||ANOVA|||Fed state||1.12|0.876|
91696999|NCT05338502|183287861|SUPERIORITY||Geometric LS Mean Ratio|0.932|||||TWO_SIDED|90.0|0.829|1.05|||ANOVA|||Fasted state||1.05|0.829|
91697000|NCT05338502|183287861|SUPERIORITY||Geometric LS Mean Ratio|1.0|||||TWO_SIDED|90.0|0.888|1.13|||ANOVA|||Fed State||1.13|0.888|
91728743|NCT03142451|183353176|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_ERROR_OF_MEAN|0.747||0.0004|TWO_SIDED|95.0|1.16|4.09|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 4||4.09|1.16|0.0004
91728744|NCT03142451|183353176|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|1.62|4.56|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 8||4.56|1.62|<0.0001
91728745|NCT03142451|183353177|SUPERIORITY||Risk Ratio (RR)|1.685||||0.0201|TWO_SIDED|95.0|1.085|2.616||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 4||2.616|1.085|0.0201
91728746|NCT03142451|183353177|SUPERIORITY||Risk Ratio (RR)|1.191||||0.1278|TWO_SIDED|95.0|0.951|1.492||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 8||1.492|0.951|0.1278
91528314|NCT02564055|182932065|OTHER||Difference in percentages|37.7|||||TWO_SIDED|95.0|14.7|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||57.6|14.7|
91528315|NCT02564055|182932065|OTHER||Difference in percentages|5.1|||||TWO_SIDED|95.0|-18.0|27.8|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||27.8|-18.0|
91697001|NCT05338502|183287863|SUPERIORITY||Geometric LS Mean Ratio|0.818|||||TWO_SIDED|90.0|0.68|0.985|||ANOVA|||Fasted State||0.985|0.680|
91697002|NCT05338502|183287863|SUPERIORITY||Geometric LS Mean Ratio|0.782|||||TWO_SIDED|90.0|0.645|0.949|||ANOVA|||Fed state||0.949|0.645|
91697003|NCT01290679|183287894|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|32.2|||<|0.001|TWO_SIDED|95.0|23.3|41.2|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.||41.2|23.3|<0.001
91697004|NCT01290679|183287895|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|29.3|||<|0.001|TWO_SIDED|95.0|20.2|38.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.||38.5|20.2|<0.001
91697005|NCT01290679|183287896|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|31.5|||<|0.001|TWO_SIDED|95.0|22.5|40.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.||40.5|22.5|<0.001
91697006|NCT01290679|183287897|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|32.3|||<|0.001|TWO_SIDED|95.0|23.5|41.0|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.||41.0|23.5|<0.001
91697007|NCT01290679|183287924|SUPERIORITY_OR_OTHER||Mean differences|-16.776|STANDARD_ERROR_OF_MEAN|6.3081||0.008|TWO_SIDED|95.0|-29.1502|-4.4025|||Piecewise Linear Model|||Fatigue Severity Score AUC60||-4.4025|-29.1502|0.008
91758915|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.274||||0.4663|TWO_SIDED|95.0|0.661|2.457||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||2.457|0.661|0.4663
91528316|NCT02564055|182932065|OTHER||Difference in percentages|17.1|||||TWO_SIDED|95.0|-6.4|39.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.0|-6.4|
91697008|NCT01290679|183287924|SUPERIORITY_OR_OTHER||Mean differences|-18.837|STANDARD_ERROR_OF_MEAN|7.4715||0.012|TWO_SIDED|95.0|-33.4933|-4.1801|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-4.1801|-33.4933|0.012
91728747|NCT00382863|183353195|SUPERIORITY_OR_OTHER|||||||0.502|||||||Fisher Exact|One-sided||Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.||||0.502
91728748|NCT00382863|183353196|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.044
91728749|NCT00382863|183353197|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.184
91728750|NCT00382863|183353198|NON_INFERIORITY_OR_EQUIVALENCE|Estimated survival for the treatment group was 93%. Estimated survival for the control group was 91.5%. A non-inferiority margin of 7.5%. Final test alpha level of 0.04825.||||||0.012|||||||Exact binomial test|One-sided||The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.||||0.012
91728751|NCT00382863|183353199|SUPERIORITY_OR_OTHER|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||Class change from baseline.||||0.052
91728752|NCT00382863|183353200|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91728753|NCT00382863|183353201|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
91728754|NCT00382863|183353202|SUPERIORITY_OR_OTHER|||||||0.54|||||||Fisher Exact|One-sided||Improvement of at least 1.0 ml/kg/min from baseline.||||0.540
91728755|NCT00382863|183353203|SUPERIORITY_OR_OTHER|||||||0.067|||||||Fisher Exact|One-sided||Improvement of at least 45 m from baseline.||||0.067
91728756|NCT00382863|183353204|SUPERIORITY_OR_OTHER|||||||0.031|||||||Fisher Exact|One-sided||Improvement of at least 7 points from baseline.||||0.031
91728757|NCT00382863|183353205|SUPERIORITY_OR_OTHER|||||||0.109|||||||Log Rank|||Kaplan-Meier actuarial time-to-first-event analysis||||0.109
91728758|NCT00382863|183353206|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.031
91728759|NCT00382863|183353207|SUPERIORITY_OR_OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.179
91728760|NCT00382863|183353208|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.070
91728761|NCT00382863|183353209|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.015
91728762|NCT00382863|183353210|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
91728763|NCT00382863|183353212|SUPERIORITY_OR_OTHER|||||||0.627|||||||Fisher Exact|Two-sided||||||0.627
91728764|NCT00382863|183353213|SUPERIORITY_OR_OTHER|||||||0.386|||||||Log Rank|||||||0.386
91528317|NCT02564055|182932065|OTHER||Difference in percentages|39.6|||||TWO_SIDED|95.0|16.0|60.0|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||60.0|16.0|
91528318|NCT02564055|182932065|OTHER||Difference in percentages|31.2|||||TWO_SIDED|95.0|7.8|52.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||52.1|7.8|
91697009|NCT01290679|183287925|SUPERIORITY_OR_OTHER||Mean differences|-282.16|STANDARD_ERROR_OF_MEAN|105.4927||0.008|TWO_SIDED|95.0|-489.1252|-75.1949|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-75.1949|-489.1252|0.008
91697010|NCT01290679|183287925|SUPERIORITY_OR_OTHER||Mean differences|-324.363|STANDARD_ERROR_OF_MEAN|124.026||0.009|TWO_SIDED|95.0|-567.708|-81.0182|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-81.0182|-567.7080|0.009
91728765|NCT00382863|183353214|SUPERIORITY_OR_OTHER|||||||0.154|||||||Fisher Exact|Two-sided||||||0.154
91728766|NCT00382863|183353215|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-sided||||||1.000
91728767|NCT00382863|183353216|SUPERIORITY_OR_OTHER|||||||0.939|||||||Log Rank|||||||0.939
91728768|NCT00382863|183353217|SUPERIORITY_OR_OTHER|||||||0.012|||||||Fisher Exact|Two-sided||||||0.012
91728769|NCT00382863|183353218|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
91728770|NCT00382863|183353219|SUPERIORITY_OR_OTHER|||||||0.772|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.772
91728771|NCT01879826|183353239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance||||||0.044|||||||t-test, 2 sided|||||||0.044
91728772|NCT01879826|183353240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance.||||||0.04|||||||t-test, 2 sided|||||||0.04
91728773|NCT02197065|183353261|OTHER||Proportion|0.2|||||ONE_SIDED|||||||||This was a pilot feasibility study and we were only powered to determine the frequency of troponin elevation in the entire study population, not to compare the frequency of a rise in troponin in the two study arms. Thus Aim 1 applies to the entire study cohort.||||
91728774|NCT02197065|183353262|SUPERIORITY||Median Difference (Final Values)|13.0||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
91728775|NCT02197065|183353263|SUPERIORITY||Median Difference (Final Values)|0.3||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
91728776|NCT01651208|183353265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Chi-squared|||We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.||||<0.01
91728777|NCT01651208|183353266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean MMAS-4 score is similar in both intervention arms||||<0.01
91728778|NCT01837550|183353310|NON_INFERIORITY_OR_EQUIVALENCE|To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen's d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power.||||||0.685|||||||Mixed Models Analysis|||||||0.685
91491016|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|3.07||||0.3443|TWO_SIDED|95.0|0.3|31.35|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||31.35|0.30|0.3443
91491017|NCT02609828|182855058|SUPERIORITY|||||||0.9527|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9527
91491018|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0757|TWO_SIDED|95.0|0.92|5.5|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.50|0.92|0.0757
91491019|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|4.51||||0.0659|TWO_SIDED|95.0|0.91|22.42|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||22.42|0.91|0.0659
91491020|NCT02609828|182855058|SUPERIORITY|||||||0.938|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9380
91697011|NCT01290679|183287926|SUPERIORITY_OR_OTHER||Mean Differences|-282.436|STANDARD_ERROR_OF_MEAN|104.9894||0.007|TWO_SIDED|95.0|-488.415|-76.4566|||Piecewise linear model|||Impairment in Daily Activities AUC60||-76.4566|-488.4150|0.007
91728779|NCT02633527|183353342|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.0899|TWO_SIDED|95.0|-13.4|1.0|||ANOVA|||||1.0|-13.4|0.0899
91528319|NCT02564055|182932065|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|2.3|48.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||48.4|2.3|
91697012|NCT01290679|183287926|SUPERIORITY_OR_OTHER||Mean differences|-329.204|STANDARD_ERROR_OF_MEAN|123.408||0.008|TWO_SIDED|95.0|-571.3389|-87.0695|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-87.0695|-571.3389|0.008
91728780|NCT02633527|183353342|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.031|TWO_SIDED|95.0|-15.1|-0.7|||ANOVA|||||-0.7|-15.1|0.0310
91528320|NCT02564055|182932065|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-5.3|40.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||40.5|-5.3|
91697013|NCT01290679|183287927|SUPERIORITY_OR_OTHER||Mean differences|-186.852|STANDARD_ERROR_OF_MEAN|121.4741||0.125|TWO_SIDED|95.0|-425.4109|51.7059|||Piecewise linear model|||Time Missed from Work AUC60||51.7059|-425.4109|0.125
91697014|NCT01290679|183287927|SUPERIORITY_OR_OTHER||Mean differences|-188.202|STANDARD_ERROR_OF_MEAN|141.1702||0.183|TWO_SIDED|95.0|-465.507|89.104|||Piecewise linear model|||Time Missed from Work AUC72||89.1040|-465.5070|0.183
91697015|NCT04431908|183287928|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|89.35|||||TWO_SIDED|||||||||||||
91491021|NCT02609828|182855058|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
91491022|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0914|TWO_SIDED|95.0|0.89|4.59|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.59|0.89|0.0914
91491023|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0359|TWO_SIDED|95.0|1.08|9.61|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.61|1.08|0.0359
91491024|NCT02609828|182855058|SUPERIORITY|||||||0.9538|||||||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9538
91491025|NCT02609828|182855058|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
91528321|NCT02564055|182932065|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-2.3|44.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||44.7|-2.3|
91528322|NCT02564055|182932065|OTHER||Difference in percentages|36.3|||||TWO_SIDED|95.0|12.1|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||57.6|12.1|
91728781|NCT02633527|183353342|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0268|TWO_SIDED|95.0|-15.3|-0.9|||ANOVA|||||-0.9|-15.3|0.0268
91728782|NCT02633527|183353342|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0209|TWO_SIDED|95.0|-15.8|-1.3|||ANOVA|||||-1.3|-15.8|0.0209
91728783|NCT02633527|183353343|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1305|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1305
91491026|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0143|TWO_SIDED|95.0|1.22|5.8|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.80|1.22|0.0143
91491027|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0176|TWO_SIDED|95.0|1.28|13.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.74|1.28|0.0176
91491028|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|3.53||||0.1298|TWO_SIDED|95.0|0.69|18.06|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||18.06|0.69|0.1298
91491029|NCT02609828|182855058|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
91491030|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0527|TWO_SIDED|95.0|0.99|4.67|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.67|0.99|0.0527
91491031|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0457|TWO_SIDED|95.0|1.02|7.12|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.12|1.02|0.0457
91491032|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0994|TWO_SIDED|95.0|0.77|19.76|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.76|0.77|0.0994
91491033|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|0.65||||0.6977|TWO_SIDED|95.0|0.07|5.86|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.86|0.07|0.6977
91491034|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.76||||0.146|TWO_SIDED|95.0|0.82|3.75|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.75|0.82|0.1460
91491035|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0742|TWO_SIDED|95.0|0.92|6.01|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.01|0.92|0.0742
91491036|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5565|TWO_SIDED|95.0|0.42|4.91|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.91|0.42|0.5565
91728784|NCT02633527|183353343|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1376|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1376
91491037|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.7||||0.5623|TWO_SIDED|95.0|0.28|10.35|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||10.35|0.28|0.5623
91491038|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.86||||0.0116|TWO_SIDED|95.0|1.27|6.47|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.47|1.27|0.0116
91528323|NCT02564055|182932065|OTHER||Difference in percentages|26.7|||||TWO_SIDED|95.0|1.7|49.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||49.0|1.7|
91528324|NCT02564055|182932065|OTHER||Difference in percentages|23.4|||||TWO_SIDED|95.0|-1.5|46.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||46.1|-1.5|
91728785|NCT02633527|183353343|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.009|TWO_SIDED|95.0|-1.3|-0.2|||ANOVA|||||-0.2|-1.3|0.0090
91728786|NCT02633527|183353343|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0546|TWO_SIDED|95.0|-1.1|0.0|||ANOVA|||||0.0|-1.1|0.0546
91728787|NCT02633527|183353344|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0708|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.0708
91728788|NCT02633527|183353344|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0309|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|||||-0.1|-1.4|0.0309
91728789|NCT02633527|183353344|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0148|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA|||||-0.2|-1.5|0.0148
91728790|NCT02633527|183353344|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0136|TWO_SIDED|95.0|-1.6|-0.2|||ANCOVA|||||-0.2|-1.6|0.0136
91491039|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0615|TWO_SIDED|95.0|0.96|5.7|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.70|0.96|0.0615
91491040|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3316|TWO_SIDED|95.0|0.59|4.8|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.80|0.59|0.3316
91528325|NCT02564055|182932065|OTHER||Difference in percentages|19.0|||||TWO_SIDED|95.0|-6.0|42.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||42.3|-6.0|
91697016|NCT04431908|183287928|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|42.55|||||TWO_SIDED|||||||||||||
91528326|NCT02564055|182932065|OTHER||Difference in percentages|-0.2|||||TWO_SIDED|95.0|-25.0|25.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||25.0|-25.0|
91528327|NCT02564055|182932065|OTHER||Difference in percentages|32.6|||||TWO_SIDED|95.0|6.9|55.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||55.0|6.9|
91528328|NCT02564055|182932065|OTHER||Difference in percentages|-9.7|||||TWO_SIDED|95.0|-34.6|16.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||16.1|-34.6|
91528329|NCT02564055|182932065|OTHER||Difference in percentages|22.3|||||TWO_SIDED|95.0|-3.1|45.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||45.3|-3.1|
91528330|NCT02564055|182932065|OTHER||Difference in percentages|6.3|||||TWO_SIDED|95.0|-19.5|31.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||31.5|-19.5|
91697017|NCT04431908|183287928|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|87.24|||||TWO_SIDED|||||||||||||
91697018|NCT04431908|183287930|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|88.73|||||TWO_SIDED|||||||||||||
91697019|NCT04431908|183287930|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|33.33|||||TWO_SIDED|||||||||||||
91697020|NCT04431908|183287930|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|88.13|||||TWO_SIDED|||||||||||||
91697021|NCT00554515|183287974|SUPERIORITY|Comparison against historical control ORR of 14%.||||||0.042|||||||exact binomial test|||||||0.042
91697022|NCT00554515|183287975|SUPERIORITY|||||||0.39|||||||Fisher Exact|||Objective response rates were compared between ISM good and poor risk subgroups. ISM good risk ORR reported under primary endpoint.||||0.39
91697023|NCT00554515|183287976|SUPERIORITY|||||||0.0014|||||||exact binomial test|||Test against the historical ORR was conducted in the overall study population as secondary analyses.||||0.0014
91697024|NCT00554515|183287979|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between MSKCC subgroups.||||.89
91697025|NCT00554515|183287981|SUPERIORITY|||||||0.33|||||||Fisher Exact|||Objective response rates were compared between tumor type subgroups||||.33
91697026|NCT00554515|183287982|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between clear cell histology subgroups||||.89
91697027|NCT00554515|183287983|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Objective response rates were compared between CA-9 score subgroups||||.19
91697028|NCT00554515|183287984|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Objective response rates were compared between PD-L1 tumor subgroups||||0.01
91697029|NCT00554515|183287985|SUPERIORITY|||||||0.08|||||||Fisher Exact|||Objective response rates were compared between B7-H3 tumor subgroups||||.08
91697030|NCT00554515|183287986|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Objective response rates were compared between CA-9 SNP subgroups||||.28
91728791|NCT06091956|183353346|SUPERIORITY|||||||0.008|||||||McNemar|||||||0.008
91491041|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9946|TWO_SIDED|95.0|0.19|5.33|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.33|0.19|0.9946
91491042|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0083|TWO_SIDED|95.0|1.33|6.76|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.76|1.33|0.0083
91491043|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.42||||0.0513|TWO_SIDED|95.0|1.0|5.88|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.88|1.00|0.0513
91491044|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1528|TWO_SIDED|95.0|0.71|8.58|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.58|0.71|0.1528
91491045|NCT02609828|182855058|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7251|TWO_SIDED|95.0|0.21|9.65|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.65|0.21|0.7251
91491046|NCT02609828|182855059|SUPERIORITY||Difference in LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.12||0.7045|TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.19|-0.28|0.7045
91491047|NCT02609828|182855059|SUPERIORITY||Difference in LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0402|TWO_SIDED|95.0|-0.59|-0.01|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||-0.01|-0.59|0.0402
91491048|NCT02609828|182855059|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.17||0.0637|TWO_SIDED|95.0|-0.67|0.02|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.02|-0.67|0.0637
91728792|NCT06091956|183353347|SUPERIORITY|||||||0.629|||||||Wilcoxon (Mann-Whitney)|||||||0.629
91528331|NCT02564055|182932065|OTHER||Difference in percentages|17.7|||||TWO_SIDED|95.0|-8.4|41.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||41.9|-8.4|
91528332|NCT02564055|182932065|OTHER||Difference in percentages|7.8|||||TWO_SIDED|95.0|-17.8|33.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||33.1|-17.8|
91528333|NCT02564055|182932065|OTHER||Difference in percentages|9.8|||||TWO_SIDED|95.0|-15.5|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||33.9|-15.5|
91728793|NCT06091956|183353350|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
91728794|NCT06091956|183353351|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91728795|NCT00318136|183353357|SUPERIORITY_OR_OTHER||Percentage of patients|3.2||||||90.0|0.3|13.5|||Blyth-Still-Casella|||||13.5|0.3|
91728796|NCT02844075|183353402|SUPERIORITY||||||||||||||||||For sample size calculation, Minimax design to evaluate the null hypothesis that the true pCR rate will be 10% and the alternative hypothesis that the pCR rate≥ 30%, with type I error (α) level of 10% and type II error (β) of 0.10. If 1 or more successes are observed in the first 16 patients, accrual for that stratum will be continued until a total of 25 patients. If, of these 25 patients, 5 or more pCR, an additional investigation is warranted. Allowing for a follow-up loss rate of 10 %, the total sample size is expected as 28. For biomarker evaluation, the categorical groups were investigated to evaluated possible association with response and/or survival. Associations were analyzed by χ2 test or Fisher's exact test for categorical variables. The Kaplan-Meier method was used to analyze survival outcomes (EFS, OS, and DFS). To compare PD-L1 expression between paired pre- and post-neoadjuvant treatment with associated of pCR, the Wilcoxon signed-rank test was used.|||
91728797|NCT03163264|183353408|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|95.0|0.0|3.45||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.050"|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.45|0|0.050
91728798|NCT03163264|183353408|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|||||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.05"|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||||0.05
91491049|NCT02609828|182855059|SUPERIORITY||Difference in LS mean|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3804|TWO_SIDED|95.0|-0.53|0.2|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.20|-0.53|0.3804
91491050|NCT02609828|182855059|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5894|TWO_SIDED|95.0|-0.47|0.27|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.27|-0.47|0.5894
91491051|NCT02609828|182855060|SUPERIORITY||Odds Ratio (OR)|0.38||||0.2033|TWO_SIDED|95.0|0.09|1.69|||Regression, Logistic|||Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||1.69|0.09|0.2033
91491052|NCT02609828|182855060|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7627|TWO_SIDED|95.0|0.41|3.41|||Regression, Logistic|||Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.41|0.41|0.7627
91491053|NCT02609828|182855060|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6894|TWO_SIDED|95.0|0.44|3.43|||Regression, Logistic|||Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.43|0.44|0.6894
91491054|NCT02609828|182855060|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5905|TWO_SIDED|95.0|0.47|3.83|||Regression, Logistic|||Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.83|0.47|0.5905
91491055|NCT02609828|182855060|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8354|TWO_SIDED|95.0|0.38|3.35|||Regression, Logistic|||Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.35|0.38|0.8354
91491056|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8069|TWO_SIDED|95.0|-0.49|0.38|||Mixed Models Analysis|||Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.38|-0.49|0.8069
91491057|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.7127|TWO_SIDED|95.0|-0.28|0.41|||Mixed Models Analysis|||Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.28|0.7127
91491058|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.3933|TWO_SIDED|95.0|-0.57|0.23|||Mixed Models Analysis|||Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.23|-0.57|0.3933
91491059|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5869|TWO_SIDED|95.0|-0.71|0.41|||Mixed Models Analysis|||Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.71|0.5869
91528334|NCT02564055|182932065|OTHER||Difference in percentages|5.8|||||TWO_SIDED|95.0|-19.7|30.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||30.5|-19.7|
91528335|NCT02564055|182932065|OTHER||Difference in percentages|17.2|||||TWO_SIDED|95.0|-9.0|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.0|
91491060|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.42|STANDARD_ERROR_OF_MEAN|0.3||0.1814|TWO_SIDED|95.0|-1.05|0.21|||Mixed Models Analysis|||Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.21|-1.05|0.1814
91491061|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2822|TWO_SIDED|95.0|-0.14|0.46|||Mixed Models Analysis|||Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.46|-0.14|0.2822
91491062|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5795|TWO_SIDED|95.0|-0.23|0.41|||Mixed Models Analysis|||Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.23|0.5795
91491063|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5486|TWO_SIDED|95.0|-0.42|0.22|||Mixed Models Analysis|||Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.22|-0.42|0.5486
91491064|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3692|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis|||Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.24|0.3692
91491065|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4724|TWO_SIDED|95.0|-0.3|0.63|||Mixed Models Analysis|||Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.30|0.4724
91491066|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.477|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.64|-0.30|0.4770
91491067|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9791|TWO_SIDED|95.0|-0.38|0.37|||Mixed Models Analysis|||Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.38|0.9791
91491068|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3574|TWO_SIDED|95.0|-0.27|0.74|||Mixed Models Analysis|||Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.74|-0.27|0.3574
91491069|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5607|TWO_SIDED|95.0|-0.77|0.42|||Mixed Models Analysis|||Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.42|-0.77|0.5607
91491070|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7143|TWO_SIDED|95.0|-0.68|0.47|||Mixed Models Analysis|||Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.47|-0.68|0.7143
91491071|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6381|TWO_SIDED|95.0|-0.28|0.45|||Mixed Models Analysis|||Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.45|-0.28|0.6381
91491072|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7181|TWO_SIDED|95.0|-0.25|0.37|||Mixed Models Analysis|||Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.25|0.7181
91491073|NCT02609828|182855063|SUPERIORITY||Difference in least square (LS) mean|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8378|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.31|-0.38|0.8378
91491074|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.795|TWO_SIDED|95.0|-0.52|0.4|||Mixed Models Analysis|||Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.52|0.7950
91491075|NCT02609828|182855063|SUPERIORITY||Difference in LS mean|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6719|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.62|0.6719
91697031|NCT03139578|183288000|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|1.18|||||TWO_SIDED|95.0|0.46|3.06|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||3.06|0.46|
91697032|NCT03139578|183288000|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|0.93|||||TWO_SIDED|95.0|0.34|2.52|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||2.52|0.34|
91697033|NCT03139578|183288001|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|93.8|||||TWO_SIDED|97.5|81.1|98.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||98.1|81.1|
91697034|NCT03139578|183288001|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|83.3|||||TWO_SIDED|97.5|68.3|92.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||92.1|68.3|
91491076|NCT01517711|182855075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286||||||P value is for overall post-randomization CAPS score|ANOVA|||Women were excluded from analysis because of the small sample size and unequal distribution across groups.||||0.286
91491077|NCT01517711|182855076|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.1|||||||ANOVA|||||||<0.10
91491078|NCT01517711|182855077|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.03|||||||ANOVA|||Analysis is for sleep only (men)||||=0.03
91491079|NCT01786668|182855079|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.8|||||TWO_SIDED|95.0|5.0|30.3|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||30.3|5.0|
91491080|NCT01786668|182855079|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.9|||||TWO_SIDED|95.0|8.4|37.7|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||37.7|8.4|
91491081|NCT01786668|182855079|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|10.7|43.4|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||43.4|10.7|
91491082|NCT01786668|182855080|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.75|STANDARD_ERROR_OF_MEAN|9.77||0.271|TWO_SIDED|95.0|-8.41|29.9|||Normal approximation for two proportions|||||29.90|-8.41|0.271
91491083|NCT01786668|182855080|SUPERIORITY_OR_OTHER||Risk Difference (RD)|39.59|STANDARD_ERROR_OF_MEAN|8.8|<|0.001|TWO_SIDED|95.0|22.35|56.83|||Normal approximation for two proportions|||||56.83|22.35|<0.001
91491084|NCT01786668|182855080|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.59|STANDARD_ERROR_OF_MEAN|9.74||0.134|TWO_SIDED|95.0|-4.5|33.69|||Normal approximation for two proportions|||||33.69|-4.50|0.134
91491085|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 2||31.04|-5.17|0.162
91491086|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 2||22.92|-12.44|0.561
91491087|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 2||24.97|-10.65|0.430
91528336|NCT02564055|182932065|OTHER||Difference in percentages|-0.6|||||TWO_SIDED|95.0|-26.0|25.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||25.0|-26.0|
91728799|NCT03163264|183353409|SUPERIORITY||Mean Difference (Net)|0.069||||0.069|TWO_SIDED|95.0|-0.13|3.39||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.39|-0.13|0.069
91758916|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.867||||0.7097|TWO_SIDED|95.0|0.406|1.848||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.848|0.406|0.7097
91491088|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
91491089|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.44|STANDARD_ERROR_OF_MEAN|9.54||0.019|TWO_SIDED|95.0|3.74|41.13|||Normal approximation for two proportions|||Week 4||41.13|3.74|0.019
91491090|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
91491091|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.56|STANDARD_ERROR_OF_MEAN|9.75||0.135|TWO_SIDED|95.0|-4.55|33.66|||Normal approximation for two proportions|||Week 8||33.66|-4.55|0.135
91491092|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.02|STANDARD_ERROR_OF_MEAN|9.36||0.003|TWO_SIDED|95.0|9.68|46.36|||Normal approximation for two proportions|||Week 8||46.36|9.68|0.003
91491093|NCT01786668|182855081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.71|STANDARD_ERROR_OF_MEAN|9.79||0.274|TWO_SIDED|95.0|-8.48|29.9|||Normal approximation for two proportions|||Week 8||29.90|-8.48|0.274
91491094|NCT01786668|182855082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.123||0.427|TWO_SIDED|95.0|-3.11|1.32|||ANCOVA|||||1.32|-3.11|0.427
91491095|NCT01786668|182855082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|1.13||0.039|TWO_SIDED|95.0|-4.58|-0.12|||ANCOVA|||||-0.12|-4.58|0.039
91491096|NCT01786668|182855082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|STANDARD_ERROR_OF_MEAN|1.131||0.016|TWO_SIDED|95.0|-4.97|-0.51|||ANCOVA|||||-0.51|-4.97|0.016
91491097|NCT01786668|182855083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.517||0.05|TWO_SIDED|95.0|-5.99|0.0|||ANCOVA|||||-0.00|-5.99|0.050
91491098|NCT01786668|182855083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.42|-2.42|||ANCOVA|||||-2.42|-8.42|<0.001
91491099|NCT01786668|182855083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|1.525|<|0.001|TWO_SIDED|95.0|-9.48|-3.46|||ANCOVA|||||-3.46|-9.48|<0.001
91491100|NCT01786668|182855084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.52||0.221|TWO_SIDED|95.0|-1.66|0.39|||ANCOVA|||||0.39|-1.66|0.221
91528337|NCT02564055|182932065|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
91728800|NCT03163264|183353409|SUPERIORITY||Mean Difference (Final Values)|1.53||||0.028|TWO_SIDED|95.0|0.21|3.76||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||3.76|0.21|0.028
91728801|NCT03163264|183353410|SUPERIORITY||Percent Difference|11.18||||0.033|TWO_SIDED|95.0|0.92|21.45|||Mixed Models Analysis|||||21.45|0.92|0.033
91728802|NCT03163264|183353411|SUPERIORITY||Percent Difference|11.08||||0.073|TWO_SIDED|95.0|-1.05|23.2||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis||Adjusted|||23.2|-1.05|0.073
91728803|NCT03163264|183353413|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.065|TWO_SIDED|95.0|-0.05|1.48||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.48|-0.05|0.065
91728804|NCT03163264|183353414|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.378|TWO_SIDED|95.0|-0.52|1.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.37|-0.52|0.378
91728805|NCT03163264|183353416|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.911|TWO_SIDED|95.0|-138.25|154.95||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||154.95|-138.25|0.911
91728806|NCT03163264|183353417|SUPERIORITY||Mean Difference (Final Values)|32.83||||0.648|TWO_SIDED|95.0|-108.15|173.81||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||173.81|-108.15|0.648
91728807|NCT03163264|183353418|SUPERIORITY||Percent Difference|10.32||||0.736|TWO_SIDED|95.0|-49.73|70.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||70.37|-49.73|0.736
91728808|NCT03163264|183353419|SUPERIORITY||Percent Difference|19.36||||0.53|TWO_SIDED|95.0|-41.09|79.8||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||79.8|-41.09|0.53
91728809|NCT04565756|183353438|OTHER|||||||||||||||||Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables. All statistical analyses were descriptive in nature and any statistical inferences were carried out according to the analysis plan and interpreted in view of the exploratory nature of the study.|Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables.|||
91491101|NCT01786668|182855084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.83|-0.78|||ANCOVA|||||-0.78|-2.83|<0.001
91491102|NCT01786668|182855084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.523||0.001|TWO_SIDED|95.0|-2.75|-0.68|||ANCOVA|||||-0.68|-2.75|0.001
91728810|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.61|1.07||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.07|0.61|
91728811|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.87|
91728812|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC Ratio|1.42|||||TWO_SIDED|95.0|1.03|1.96||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.96|1.03|
91728813|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.84|0.46|
91728814|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.66|1.2||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.66|
91728815|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.44|||||TWO_SIDED|95.0|1.02|2.04||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.04|1.02|
91728816|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.82|1.32||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.32|0.82|
91491103|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
91491104|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
91491105|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.62|STANDARD_ERROR_OF_MEAN|7.31||0.824|TWO_SIDED|95.0|-12.71|15.95|||Normal approximation for two proportions|||Week 2||15.95|-12.71|0.824
91491106|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.16|STANDARD_ERROR_OF_MEAN|8.09||0.104|TWO_SIDED|95.0|-2.69|29.01|||Normal approximation for two proportions|||Week 4||29.01|-2.69|0.104
91491107|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.01|STANDARD_ERROR_OF_MEAN|8.26||0.04|TWO_SIDED|95.0|0.81|33.2|||Normal approximation for two proportions|||Week 4||33.20|0.81|0.040
91728817|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.86|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.86|
91491108|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 4||20.40|-9.46|0.473
91728818|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.79|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.79|
91728819|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.77|1.34||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.34|0.77|
91728820|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
91491109|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|8.86||0.875|TWO_SIDED|95.0|-15.97|18.76|||Normal approximation for two proportions|||Week 8||18.76|-15.97|0.875
91491110|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
91491111|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.09|STANDARD_ERROR_OF_MEAN|9.15||0.32|TWO_SIDED|95.0|-8.84|27.01|||Normal approximation for two proportions|||Week 8||27.01|-8.84|0.320
91697035|NCT03139578|183288001|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100|90.5|
91697036|NCT03139578|183288001|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100.0|90.5|
91697037|NCT03139578|183288002|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.7|-0.3|
91697038|NCT03139578|183288002|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
91697039|NCT03139578|183288003|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.4|
91697040|NCT03139578|183288003|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.2|
91697041|NCT03139578|183288004|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.1|
91697042|NCT03139578|183288004|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.2|
91491112|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 12||39.99|5.41|0.010
91491113|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.55|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|95.0|9.16|43.93|||Normal approximation for two proportions|||Week 12||43.93|9.16|0.003
91697043|NCT03139578|183288005|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
91697044|NCT03139578|183288005|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.6|
91697045|NCT03139578|183288006|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.002|||||TWO_SIDED|95.0|-0.009|0.012|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.012|-0.009|
91728821|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.74|1.4||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.40|0.74|
91728822|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.57|0.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.97|0.57|
91491114|NCT01786668|182855085|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.85|STANDARD_ERROR_OF_MEAN|8.74||0.031|TWO_SIDED|95.0|1.72|35.99|||Normal approximation for two proportions|||Week 12||35.99|1.72|0.031
91491115|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.23|STANDARD_ERROR_OF_MEAN|6.95||0.028|TWO_SIDED|95.0|1.61|28.86|||Normal approximation for two proportions|||Week 2||28.86|1.61|0.028
91491116|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 2||17.47|-6.23|0.353
91491117|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.31|STANDARD_ERROR_OF_MEAN|6.8||0.05|TWO_SIDED|95.0|-0.02|26.64|||Normal approximation for two proportions|||Week 2||26.64|-0.02|0.050
91697046|NCT03139578|183288006|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.001|||||TWO_SIDED|95.0|-0.012|0.009|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.009|-0.012|
91728823|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.65|1.11||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.11|0.65|
91728824|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMCratio|1.14|||||TWO_SIDED|95.0|0.84|1.56||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.56|0.84|
91491118|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.39|STANDARD_ERROR_OF_MEAN|6.64||0.086|TWO_SIDED|95.0|-1.62|24.39|||Normal approximation for two proportions|||Week 4||24.39|-1.62|0.086
91491119|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.93|STANDARD_ERROR_OF_MEAN|7.43||0.002|TWO_SIDED|95.0|8.37|37.48|||Normal approximation for two proportions|||Week 4||37.48|8.37|0.002
91728825|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.97|1.94||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.94|0.97|
91728826|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.78|1.55||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.55|0.78|
91728827|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.54|1.19||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.19|0.54|
91758917|NCT00265317|183410823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.607||||0.534|TWO_SIDED|95.0|0.117|3.158||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||3.158|0.117|0.5340
91491120|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|STANDARD_ERROR_OF_MEAN|7.32||0.004|TWO_SIDED|95.0|6.65|35.36|||Normal approximation for two proportions|||Week 4||35.36|6.65|0.004
91491121|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.35|STANDARD_ERROR_OF_MEAN|7.03||0.106|TWO_SIDED|95.0|-2.43|25.13|||Normal approximation for two proportions|||Week 8||25.13|-2.43|0.106
91491122|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.5|STANDARD_ERROR_OF_MEAN|8.02|<|0.001|TWO_SIDED|95.0|16.79|48.22|||Normal approximation for two proportions|||Week 8||48.22|16.79|<0.001
91491123|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.04|STANDARD_ERROR_OF_MEAN|7.54||0.012|TWO_SIDED|95.0|4.27|33.81|||Normal approximation for two proportions|||Week 8||33.81|4.27|0.012
91491124|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.54|STANDARD_ERROR_OF_MEAN|7.47||0.635|TWO_SIDED|95.0|-11.1|18.19|||Normal approximation for two proportions|||Week 12||18.19|-11.10|0.635
91491125|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|34.31|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|17.45|51.18|||Normal approximation for two proportions|||Week 12||51.18|17.45|<0.001
91491126|NCT01786668|182855086|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.78|STANDARD_ERROR_OF_MEAN|8.45||0.007|TWO_SIDED|95.0|6.21|39.34|||Normal approximation for two proportions|||Week 12||39.34|6.21|0.007
91491127|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.136||0.175|TWO_SIDED|95.0|-0.46|0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.08|-0.46|0.175
91491128|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.77|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.24|-0.77|<0.001
91491129|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.20|-0.74|<0.001
91491130|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|-0.7|-0.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.15|-0.70|0.003
91528338|NCT02564055|182932065|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
91697047|NCT03793842|183288007|EQUIVALENCE|Equivalence margin 1 J/min||||||0.002|||||||t-test, 2 sided|||||||.002
91697048|NCT03793842|183288008|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
91697049|NCT03793842|183288009|EQUIVALENCE|Equivalence margin 1 cm H20|Mean Difference (Net)|0.05||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
91697050|NCT03793842|183288010|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91697051|NCT03793842|183288011|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
91491131|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.9|-0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.34|-0.90|<0.001
91697052|NCT02549287|183288016|SUPERIORITY||Odds Ratio, log|0.55||||0.12|TWO_SIDED|95.0|-0.11|1.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.20|-0.11|0.12
91491132|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.86|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.31|-0.86|<0.001
91697053|NCT02549287|183288017|SUPERIORITY||Odds Ratio, log|0.41||||0.14|TWO_SIDED|95.0|-0.2|1.03||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.03|-0.20|0.14
91697054|NCT02549287|183288018|SUPERIORITY||Odds Ratio, log|0.44||||0.2|TWO_SIDED|95.0|-0.2|1.07||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.07|-0.20|0.20
91697055|NCT02549287|183288019|SUPERIORITY||Odds Ratio, log|-0.07||||0.77|TWO_SIDED|95.0|-0.58|0.43||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.43|-0.58|0.77
91697056|NCT02549287|183288020|SUPERIORITY||Odds Ratio, log|0.35||||0.29|TWO_SIDED|95.0|-0.27|0.97|||Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.97|-0.27|0.29
91697057|NCT02549287|183288021|SUPERIORITY||Odds Ratio, log|0.49||||0.15|TWO_SIDED|95.0|-0.08|1.06||Other \[Marginal Model (e.g., GEE)\]|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.06|-0.08|0.15
91728828|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.61|1.05||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.05|0.61|
91491133|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.158||0.026|TWO_SIDED|95.0|-0.66|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.04|-0.66|0.026
91491134|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.157|<|0.001|TWO_SIDED|95.0|-0.94|-0.32|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.32|-0.94|<0.001
91697058|NCT02549287|183288022|SUPERIORITY||Odds Ratio, log|-0.11||||0.61|TWO_SIDED|95.0|-0.73|0.52||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.52|-0.73|0.61
91697059|NCT02549287|183288023|SUPERIORITY||Odds Ratio, log|-0.22||||0.47|TWO_SIDED|95.0|-0.76|0.32||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.32|-0.76|0.47
91697060|NCT02549287|183288024|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-3.7|2.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||2.20|-3.70|0.65
91697061|NCT02549287|183288025|SUPERIORITY||Odds Ratio, log|0.05||||0.64|TWO_SIDED|95.0|-0.59|0.69||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.69|-0.59|0.64
91697062|NCT02549287|183288026|SUPERIORITY||Odds Ratio, log|-0.25||||0.44|TWO_SIDED|95.0|-0.79|0.29||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.29|-0.79|0.44
91697063|NCT02549287|183288027|SUPERIORITY||Odds Ratio, log|0.25||||0.47|TWO_SIDED|95.0|-0.39|0.89||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.89|-0.39|0.47
91697064|NCT02549287|183288028|SUPERIORITY||Slope|-0.18||||0.63|TWO_SIDED|95.0|-3.57|3.22||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||3.22|-3.57|0.63
91697065|NCT01377922|183288103|OTHER|Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline QMG score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||||0.0452|||||||Mixed Models Analysis|Pairwise contrast at Day 14 from MMRM model.||||||0.0452
91697066|NCT01377922|183288104|OTHER|||||||0.0028||||||Pairwise contrast at Day 14 from MMRM model.|Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline SGI score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0028
91697067|NCT01377922|183288105|OTHER|||||||0.6274|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline T25FW walking speed as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||0.6274
91697068|NCT01377922|183288106|OTHER|||||||0.0267|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0267
91697069|NCT00665431|183288108|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority margin (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.94|3.34|||ANCOVA|||||3.34|-5.94|
91697070|NCT00665431|183288109|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-2.11|||||TWO_SIDED|95.0|-6.82|2.6|||ANCOVA|||||2.60|-6.82|
91697071|NCT00665431|183288110|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|3.45|||||TWO_SIDED|95.0|-1.41|8.31|||ANCOVA|||||8.31|-1.41|
91728829|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.95|||||TWO_SIDED|95.0|0.73|1.25||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.73|
91728830|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.87|1.64||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.64|0.87|
91728831|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|3.62|||||TWO_SIDED|95.0|2.76|4.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.74|2.76|
91491135|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.159|<|0.001|TWO_SIDED|95.0|-0.9|-0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.27|-0.90|<0.001
91491136|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.171||0.002|TWO_SIDED|95.0|-0.89|-0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.21|-0.89|0.002
91528339|NCT02564055|182932065|OTHER||Difference in percentages|28.6|||||TWO_SIDED|95.0|-19.2|71.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||71.0|-19.2|
91728832|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
91728833|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.14|||||TWO_SIDED|95.0|0.1|0.2||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.10|
91728834|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.13|||||TWO_SIDED|95.0|0.8|1.59||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.59|0.80|
91728835|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.62|
91728836|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.52|1.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.52|
91728837|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|3.49|||||TWO_SIDED|95.0|2.68|4.54||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.54|2.68|
91491137|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.171|<|0.001|TWO_SIDED|95.0|-1.07|-0.39|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.39|-1.07|<0.001
91491138|NCT01786668|182855087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.172|<|0.001|TWO_SIDED|95.0|-1.03|-0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.35|-1.03|<0.001
91491139|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.24|STANDARD_ERROR_OF_MEAN|7.99||0.159|TWO_SIDED|95.0|-4.41|26.89|||Normal approximation for two proportions|||Week 2||26.89|-4.41|0.159
91528340|NCT02564055|182932065|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
91697072|NCT02547220|183288120|SUPERIORITY||Difference in percentage|2.6||||0.6857|TWO_SIDED|95.0|-29.4|34.5|||Fisher Exact||Difference in percentage was calculated by the difference in percentage of new or worsening TG at 6 months between CINRYZE and placebo|||34.5|-29.4|0.6857
91697073|NCT03771560|183288157|OTHER||Mean Difference (Final Values)|-2.4||||0.56|TWO_SIDED|95.0|-11.3|6.4|||Paired Sample t-test|||The parent-reported change in mean ABC total score from baseline to week 12.||6.4|-11.3|0.56
91697074|NCT03771560|183288158|OTHER||Mean Difference (Final Values)|1.2||||0.68|TWO_SIDED|95.0|-5.2|7.6|||Paired Sample t-test|||The teacher-reported change in mean ABC total score from baseline to week 12.||7.6|-5.2|0.68
91697075|NCT03771560|183288159|OTHER||Mean Difference (Final Values)|-7.8||||0.095|TWO_SIDED|95.0|-17.3|1.6|||Paired Sample t-test|||The parent-reported change in mean SRS total score from baseline to week 12.||1.6|-17.3|0.095
91697076|NCT03771560|183288160|OTHER||Median Difference (Final Values)|-0.5||||0.95|TWO_SIDED|95.0|-7.0|13.5|||Wilcoxon (Mann-Whitney)|||The teacher-reported change in mean SRS total score from baseline to week 12.||13.5|-7.0|0.95
91697077|NCT03771560|183288161|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|95.0|-5.2|3.5|||Paired Sample t-test|||The parent-reported change in mean PedsQL total score from baseline to week 12.||3.5|-5.2|0.69
91528341|NCT02564055|182932066|OTHER||Difference in percentages|5.3|||||TWO_SIDED|95.0|-18.3|28.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||28.4|-18.3|
91697078|NCT02887183|183288162|OTHER||Least Squared Geometric Mean Ratio|0.632|||<|0.0001|TWO_SIDED|95.0|0.5865|0.681|||ANCOVA|||||0.6810|0.5865|<.0001
91697079|NCT02887183|183288163|OTHER||Least Squared Mean|-7.57|||<|0.0001|TWO_SIDED|95.0|-7.98|-7.15|||ANCOVA|||LAVi||-7.15|-7.98|<.0001
91697080|NCT02887183|183288163|OTHER||Least Squared Mean|-12.25|||<|0.0001|TWO_SIDED|95.0|-12.92|-11.58|||ANCOVA|||LVEDVi||-11.58|-12.92|<.0001
91697081|NCT02887183|183288163|OTHER||Least Squared Mean|-15.29|||<|0.0001|TWO_SIDED|95.0|-16.03|-14.55|||ANCOVA|||LVESVi||-14.55|-16.03|<.0001
91697082|NCT02887183|183288164|OTHER||Least Squared Mean|9.37|||<|0.001|TWO_SIDED|95.0|8.84|9.9|||ANCOVA|||||9.90|8.84|<.001
91697083|NCT02887183|183288165|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
91697084|NCT02887183|183288166|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
91697085|NCT02887183|183288167|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||<.0001
91697086|NCT02887183|183288167|OTHER|Pearson's Correlation||||||0.0003|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0003
91697087|NCT02887183|183288167|OTHER|Pearson's Correlation||||||0.0956|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0956
91728838|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
91758918|NCT00265317|183410826|SUPERIORITY_OR_OTHER|||||||0.2702|||||||Wilcoxon Rank Sum Test|||VEGF-C Ratio to Baseline for Cycle 2, Day 1||||0.2702
91528342|NCT02564055|182932066|OTHER||Difference in percentages|5.9|||||TWO_SIDED|95.0|-17.1|28.4|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||28.4|-17.1|
91528343|NCT02564055|182932066|OTHER||Difference in percentages|-0.8|||||TWO_SIDED|95.0|-24.0|22.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||22.7|-24.0|
91697088|NCT02887183|183288168|OTHER|Pearson's Correlation||||||0.006|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0060
91697089|NCT02887183|183288168|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0012
91697090|NCT02887183|183288168|OTHER|Pearson's Correlation||||||0.0181|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0181
91697091|NCT02887183|183288169|OTHER|Pearson's Correlation||||||0.2498|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.2498
91697092|NCT02887183|183288169|OTHER|Pearson's Correlation||||||0.0495|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0495
91697093|NCT02887183|183288169|OTHER|Pearson's Correlation||||||0.2685|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.2685
91697094|NCT02887183|183288170|OTHER|Pearson's Correlation||||||0.0029|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0029
91697095|NCT02887183|183288170|OTHER|Pearson's Correlation||||||0.0011|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0011
91697096|NCT02887183|183288170|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0012
91697097|NCT02887183|183288171|OTHER||Least Squared Mean|9.32|||<|0.0001|TWO_SIDED|95.0|7.94|10.69|||ANCOVA|||||10.69|7.94|<.0001
91697098|NCT03634033|183288172|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on adoption and sustainability using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|10.89|STANDARD_DEVIATION|18.17||0.22|TWO_SIDED|95.0|-7.27|29.05||A priori threshold for statistical significance was .05|t-test, 2 sided|16 degrees of freedom for the t-test comparing two independent groups, n=9 each.||Given 18 sites (9 in each arm) available in Michigan, in the comparison of site-level outcome of adoption and sustainability, the detectable effect size with power of 0.80 in two-sided tests at .05 level of significance was d=1.41.||29.05|-7.27|0.22
91697099|NCT03634033|183288173|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ADLs at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.73|TWO_SIDED|95.0|-0.16|0.73||A priori threshold for statistical significance was .05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering via a random effect of site.|IF minus IF+EF|Adjusted means at month 9 were calculated adjusting for baseline value of the outcome and nesting of participants within sites.||0.73|-0.16|0.73
91697100|NCT03634033|183288174|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries IADLs using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.15|TWO_SIDED|95.0|-0.11|0.72||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|Post-intervention means were compared adjusting for baseline values and nesting of participants within sites.||0.72|-0.11|0.15
91697101|NCT03634033|183288175|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries pain at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.61|TWO_SIDED|95.0|-0.23|0.39||Threshold for statistical significance was.05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|||0.39|-0.23|0.61
91697102|NCT03634033|183288176|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries depression (baseline to exit) using an evidence-based intervention (CAPABLE).|LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.04|TWO_SIDED|95.0|0.01|0.24|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||0.24|0.01|0.04
91758919|NCT00265317|183410826|SUPERIORITY_OR_OTHER|||||||0.7354||95.0|||||Wilcoxon Rank Sum Test|||VEGF-C ratio to Baseline for Cycle 3, Day 1||||0.7354
91758920|NCT00265317|183410828|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
91491140|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.39|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|15.54|49.24|||Normal approximation for two proportions|||Week 2||49.24|15.54|<0.001
91491141|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|STANDARD_ERROR_OF_MEAN|8.5||0.004|TWO_SIDED|95.0|8.04|41.36|||Normal approximation for two proportions|||Week 2||41.36|8.04|0.004
91728839|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.11|0.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.11|
91728840|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.61|||||TWO_SIDED|95.0|1.15|2.23||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.23|1.15|
91728841|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.89|1.72||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.72|0.89|
91728842|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.53|1.13||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.53|
91728843|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.63|||||TWO_SIDED|95.0|1.28|2.08||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.08|1.28|
91728844|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.03|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.81|
91728845|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.47|0.83||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.83|0.47|
91728846|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.99|||||TWO_SIDED|95.0|1.51|2.63||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.63|1.51|
91728847|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
91728848|NCT01026038|183353462|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.38|0.72||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.72|0.38|
91728849|NCT01026038|183353463|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
91728850|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.429||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.429
91728851|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.314
91728852|NCT01026038|183353463|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
91728853|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.552||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.552
91728854|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.499
91728855|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.376||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.376
91491142|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 4||39.99|5.41|0.010
91728856|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.633
91491143|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.08|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|20.79|55.38|||Normal approximation for two proportions|||Week 4||55.38|20.79|<0.001
91491144|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.32|STANDARD_ERROR_OF_MEAN|8.88|<|0.001|TWO_SIDED|95.0|14.9|49.73|||Normal approximation for two proportions|||Week 4||49.73|14.90|<0.001
91491145|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.82|STANDARD_ERROR_OF_MEAN|9.39||0.114|TWO_SIDED|95.0|-3.58|33.22|||Normal approximation for two proportions|||Week 8||33.22|-3.58|0.114
91491146|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
91491147|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
91491148|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.47|STANDARD_ERROR_OF_MEAN|9.33||0.009|TWO_SIDED|95.0|6.18|42.76|||Normal approximation for two proportions|||Week 12||42.76|6.18|0.009
91491149|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.01|STANDARD_ERROR_OF_MEAN|9.15|<|0.001|TWO_SIDED|95.0|18.09|53.94|||Normal approximation for two proportions|||Week 12||53.94|18.09|<0.001
91697103|NCT03634033|183288177|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries fall rates at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.16|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|95.0|0.93|1.45|||Mixed Models Analysis|||||1.45|0.93|0.18
91697104|NCT03634033|183288177|SUPERIORITY||Odds Ratio (OR)|1.16||||0.18|TWO_SIDED|95.0|0.93|1.45||Threshold for statistical significance was .05; no adjustment for multiple comparisons.|Mixed Models Analysis||Odds ratio for IF versus IF+EF|Occurrence of falls was analyzed with adjustment for baseline and nesting of participants within sites.||1.45|0.93|.18
91697105|NCT03634033|183288178|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ED Visits at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.01||0.86|TWO_SIDED|95.0|0.79|1.22||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|Adjustment for baseline and nesting of participants within sites.||||1.22|0.79|0.86
91697106|NCT03634033|183288179|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries hospitalizations (baseline to exit) using an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|0.72|1.42|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||1.42|0.72|0.95
91697107|NCT03634033|183288180|SUPERIORITY|Examination of clinician attitude on facilitation (IF vs IF+EF) at exit when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.55||0.05|TWO_SIDED|95.0|0.09|10.14|||Mixed Models Analysis|||Mixed modeling was used to account for nesting of clinicians within sites.||10.14|0.09|0.05
91697108|NCT03634033|183288181|OTHER|Examination of clinician self-efficacy on facilitation (IF vs IF+EF) (baseline to exit) when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.36||0.54|TWO_SIDED|95.0|-0.51|0.97||Threshold for statistical significance was .05 with no adjustments for multiple testing.|Mixed Models Analysis|Nesting of clinicians within site was adjusted for as a random effect.||||0.97|-0.51|0.54
91697109|NCT03634033|183288184|SUPERIORITY|Pre-/post-intervention comparison.|Mean Difference (Net)|-2.69|STANDARD_ERROR_OF_MEAN|1.63|<|0.01|TWO_SIDED|95.0|-3.96|-1.42|||t-test, 2 sided||Pre minus post|Pain||-1.42|-3.96|<.01
91697110|NCT03634033|183288184|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.9||0.58|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||ADL||4.91|-2.80|.58
91697111|NCT03634033|183288184|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.29||0.44|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||IADL||4.91|-2.80|.44
91697112|NCT03634033|183288184|SUPERIORITY||Mean Difference (Net)|1.46|STANDARD_ERROR_OF_MEAN|1.63||0.38|TWO_SIDED|95.0|-1.85|4.77||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Depression||4.77|-1.85|.38
91697113|NCT03634033|183288185|SUPERIORITY|Self-efficacy|Mean Difference (Net)|-0.81|STANDARD_DEVIATION|0.11|<|0.01|TWO_SIDED|95.0|-1.02|-0.6||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Self-efficacy change baseline (month-0) to exit (month-4).||-0.60|-1.02|<0.01
91697114|NCT03634033|183288186|OTHER|Score on scale.|Mean|8.09|STANDARD_DEVIATION|1.6|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<.01
91697115|NCT03634033|183288186|OTHER||Mean|7.55|STANDARD_DEVIATION|2.06|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Satisfaction with format||||<.01
91697116|NCT03634033|183288186|OTHER||Mean|8.35|STANDARD_DEVIATION|1.5|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for caregiver||||<.01
91697117|NCT03634033|183288186|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for clinician||||<.01
91697118|NCT03634033|183288186|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Intent to use new information||||<.01
91697119|NCT06366087|183288187|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.7|||||TWO_SIDED|90.0|0.67|0.724|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCinf lies within 80.00 to 125.00%.|||0.724|0.670|
91697120|NCT06366087|183288188|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.67|||||TWO_SIDED|90.0|0.64|0.697|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCt lies within 80.00 to 125.00%.|||0.697|0.640|
91697121|NCT06366087|183288189|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.11|||||TWO_SIDED|90.0|0.088|0.136|||Mixed Models Analysis|||||0.136|0.088|
91697122|NCT06366087|183288190|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.15|||||TWO_SIDED|90.0|0.12|0.189|||Mixed Models Analysis|||||0.189|0.120|
91491150|NCT01786668|182855088|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.32|STANDARD_ERROR_OF_MEAN|9.3||0.002|TWO_SIDED|95.0|10.09|46.55|||Normal approximation for two proportions|||Week 12||46.55|10.09|0.002
91491151|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
91491152|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
91491153|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
91697123|NCT06366087|183288191|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.26|||||TWO_SIDED|90.0|0.217|0.309|||Mixed Models Analysis|||||0.309|0.217|
91697124|NCT06366087|183288192|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.36|||||TWO_SIDED|90.0|0.318|0.416|||Mixed Models Analysis|||||0.416|0.318|
91697125|NCT06366087|183288193|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.44|||||TWO_SIDED|90.0|0.396|0.492|||Mixed Models Analysis|||||0.492|0.396|
91697126|NCT06366087|183288194|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.532|0.608|||Mixed Models Analysis|||||0.608|0.532|
91697127|NCT06366087|183288195|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.524|0.62|||Mixed Models Analysis|||||0.620|0.524|
91697128|NCT00504725|183288230|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.|ANOVA|||IL-6||||0.39
91697129|NCT00504725|183288230|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||IL-8||||0.18
91697130|NCT00504725|183288230|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||IL-10||||0.14
91697131|NCT00504725|183288231|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
91697132|NCT00504725|183288232|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||Baseline Pain Level Score|Fisher Exact|||||||0.44
91697133|NCT00504725|183288232|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||4 Hour Pain Level Score|Fisher Exact|||||||0.20
91697134|NCT00504725|183288232|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||24 Hour Pain Level Score|Fisher Exact|||||||0.37
91697135|NCT00504725|183288232|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Pain Level Score at Discharge|Fisher Exact|||||||0.15
91697136|NCT01435018|183288233|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically relevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-30.3|||||TWO_SIDED|95.0|-52.3|-8.3|||||Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-8.3|-52.3|
91697137|NCT01435018|183288234|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-19.8|||||TWO_SIDED|95.0|-32.3|-7.4|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-7.4|-32.3|
91697138|NCT01435018|183288234|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-20.1|||||TWO_SIDED|95.0|-32.2|-7.9|||||Confidence interval estimation was stratified by country using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative PFS rate with 95% two-sided confidence interval.||-7.9|-32.2|
91697139|NCT01435018|183288235|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
91491154|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
91491155|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
91697140|NCT01435018|183288236|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
91697141|NCT01435018|183288238|OTHER||Cumulative rate difference|16.3|||||TWO_SIDED|95.0|3.7|28.8||||||Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of IERC-confirmed KS progression with 95% two-sided confidence interval.|Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|28.8|3.7|
91697142|NCT01435018|183288239|OTHER||Cumulative rate difference|-15.0|||||TWO_SIDED|95.0|-34.4|4.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||4.3|-34.4|
91697143|NCT01435018|183288240|OTHER||Cumulative rate difference|-3.3|||||TWO_SIDED|95.0|-13.3|6.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||6.6|-13.3|
91697144|NCT01435018|183288241|OTHER||Cumulative rate difference|4.3|||||TWO_SIDED|95.0|-1.9|10.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||10.6|-1.9|
91697145|NCT01435018|183288242|OTHER||Cumulative rate difference|5.5|||||TWO_SIDED|95.0|-0.1|11.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||11.0|-0.1|
91697146|NCT01435018|183288245|OTHER||Cumulative rate difference|19.4|||||TWO_SIDED|95.0|-4.1|43.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||43.0|-4.1|
91697147|NCT01435018|183288246|OTHER||Cumulative rate difference|14.4|||||TWO_SIDED|95.0|1.8|27.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||27.0|1.8|
91697148|NCT01435018|183288247|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||47.4|0.9|
91697149|NCT01435018|183288248|OTHER||Cumulative rate difference|18.8|||||TWO_SIDED|95.0|6.3|31.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||31.3|6.3|
91697150|NCT01435018|183288249|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||47.4|0.9|
91697151|NCT01435018|183288250|OTHER||Cumulative rate difference|17.7|||||TWO_SIDED|95.0|6.2|29.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||29.3|6.2|
91697152|NCT01435018|183288251|OTHER||Cumulative rate difference|37.5|||||TWO_SIDED|95.0|13.6|61.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||61.4|13.6|
91697153|NCT01435018|183288252|OTHER||Cumulative rate difference|11.1|||||TWO_SIDED|95.0|-0.4|22.7|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||22.7|-0.4|
91697154|NCT01435018|183288253|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
91491156|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5|STANDARD_ERROR_OF_MEAN|5.99||0.113|TWO_SIDED|95.0|-2.24|21.24|||Normal approximation for two proportions|||Week 4||21.24|-2.24|0.113
91728857|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.658
91728858|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.544
91728859|NCT01026038|183353463|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728860|NCT01026038|183353463|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728861|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
91728862|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.197
91728863|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.198
91728864|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.443||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.443
91728865|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.261
91728866|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.687
91728867|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.671
91728868|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.253
91728869|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.074
91728870|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
91491157|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.73|STANDARD_ERROR_OF_MEAN|6.08||0.775|TWO_SIDED|95.0|-10.18|13.65|||Normal approximation for two proportions|||Week 8||13.65|-10.18|0.775
91491158|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.12|STANDARD_ERROR_OF_MEAN|7.43||0.021|TWO_SIDED|95.0|2.56|31.68|||Normal approximation for two proportions|||Week 8||31.68|2.56|0.021
91491159|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.27|STANDARD_ERROR_OF_MEAN|7.17||0.064|TWO_SIDED|95.0|-0.79|27.34|||Normal approximation for two proportions|||Week 8||27.34|-0.79|0.064
91728871|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
91728872|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.607
91728873|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.549
91728874|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.864||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.864
91728875|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
91728876|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.836
91728877|NCT01026038|183353463|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728878|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.297
91728879|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.145
91728880|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.517
91758921|NCT00265317|183410828|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
91758922|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.553||||0.1667|TWO_SIDED|95.0|0.159|1.921||1-sided unstratified log-rank test|Log Rank|||High CSF-1R expression||1.921|0.159|0.1667
91758923|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.451||||0.7688|TWO_SIDED|95.0|0.534|3.944||1-sided unstratified log-rank test|Log Rank|||Low CSF-1R expression||3.944|0.534|0.7688
91758924|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3498|TWO_SIDED|95.0|0.503|1.574||1-sided unstratified log-rank test|Log Rank|||Indeterminate CSF-1R expression||1.574|0.503|0.3498
91491160|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.47|STANDARD_ERROR_OF_MEAN|7.09||0.292|TWO_SIDED|95.0|-6.42|21.36|||Normal approximation for two proportions|||Week 12||21.36|-6.42|0.292
91491161|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.31|STANDARD_ERROR_OF_MEAN|7.38||0.125|TWO_SIDED|95.0|-3.16|25.78|||Normal approximation for two proportions|||Week 12||25.78|-3.16|0.125
91728881|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
91728882|NCT01026038|183353463|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
91728883|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC||||0.075
91728884|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.345
91728885|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.628
91728886|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.592||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.592
91728887|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.608
91728888|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728889|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728890|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.333
91728891|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
91728892|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
91728893|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
91728894|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
91728895|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
91728896|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
91728897|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
91728898|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
91728899|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728900|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
91728901|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
91728902|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728903|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
91728904|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728905|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.237
91491162|NCT01786668|182855089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.24|STANDARD_ERROR_OF_MEAN|7.51||0.078|TWO_SIDED|95.0|-1.49|27.96|||Normal approximation for two proportions|||Week 12||27.96|-1.49|0.078
91491163|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
91728906|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.045
91728907|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.285
91728908|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
91728909|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.174
91728910|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.125
91728911|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.058
91491164|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
91491165|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
91728912|NCT01026038|183353464|SUPERIORITY_OR_OTHER|||||||0.092||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.092
91728913|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728914|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
91728915|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728916|NCT01026038|183353464|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
91728917|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.56|1.0||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.56|
91728918|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.73|1.28||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.28|0.73|
91728919|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC Ratio|1.29|||||TWO_SIDED|95.0|0.92|1.79||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.92|
91728920|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.49|1.0||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.49|
91728921|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.62|1.27||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.62|
91728922|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.27|||||TWO_SIDED|95.0|0.84|1.94||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.84|
91728923|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.58|1.03||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.03|0.58|
91728924|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.76|1.33||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.33|0.76|
91728925|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.29|||||TWO_SIDED|95.0|0.93|1.8||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.80|0.93|
91728926|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.69|1.58||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.58|0.69|
91491166|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 4||5.29|-5.37|0.989
91491167|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 4||11.20|-3.58|0.313
91491168|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 4||13.91|-2.45|0.170
91697155|NCT01435018|183288254|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
91728927|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.3|||||TWO_SIDED|95.0|0.86|1.97||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.86|
91491169|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 8||11.20|-3.58|0.313
91697156|NCT01435018|183288255|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.1|3.4|||||Hazard ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||3.4|1.1|
91697157|NCT01435018|183288256|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|1.1|2.2|||||Hazard ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||2.2|1.1|
91697158|NCT01435018|183288257|OTHER||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.1|0.7|||||Odds ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||0.7|0.1|
91697159|NCT01435018|183288258|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Odds ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count and country.|||1.3|0.5|
91697160|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Asiatic acid||||0.01
91697161|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Caffeic acid||||0.23
91697162|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.001||||||Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Dihydrocaffeic acid||||0.001
91697163|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Dihydroferulic acid||||0.05
91697164|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.07|||||||t-test, 2 sided|||Ferulic acid||||0.07
91697165|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.09
91697166|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.003|||||||t-test, 2 sided|||Isoferulic acid||||0.003
91697167|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Madecassic acid||||0.10
91697168|NCT03937908|183288278|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.11|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.11
91697169|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.82|||||||t-test, 2 sided|||Asiatic acid||||0.82
91697170|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Caffeic acid||||0.40
91728928|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.77|2.03||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.77|
91728929|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.58|||||TWO_SIDED|95.0|0.42|0.78||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.78|0.42|
91491170|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 8||5.29|-5.37|0.989
91697171|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.20
91697172|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.48|||||||t-test, 2 sided|||Dihydroferulic acid||||0.48
91697173|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Ferulic acid||||0.20
91697174|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.32|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.32
91728930|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
91491171|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.65|STANDARD_ERROR_OF_MEAN|4.53||0.091|TWO_SIDED|95.0|-1.22|16.52|||Normal approximation for two proportions|||Week 8||16.52|-1.22|0.091
91491172|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
91491173|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
91728931|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.58|||||TWO_SIDED|95.0|1.11|2.25||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.25|1.11|
91728932|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.66|
91728933|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.54|||||TWO_SIDED|95.0|0.97|2.44||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.44|0.97|
91728934|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.46|||||TWO_SIDED|95.0|0.85|2.51||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.51|0.85|
91728935|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.56|
91491174|NCT01786668|182855090|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.54|STANDARD_ERROR_OF_MEAN|6.26||0.228|TWO_SIDED|95.0|-4.73|19.81|||Normal approximation for two proportions|||Week 12||19.81|-4.73|0.228
91491175|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.926|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.58|-0.64|0.926
91728936|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.74|1.52||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.74|
91728937|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|0.87|2.01||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.01|0.87|
91728938|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|2.59|||||TWO_SIDED|95.0|1.8|3.73||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.73|1.80|
91728939|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.26|||||TWO_SIDED|95.0|0.88|1.79||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.88|
91728940|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.49|||||TWO_SIDED|95.0|0.32|0.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.32|
91728941|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.61|1.87||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.87|0.61|
91728942|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.68|2.09||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.09|0.68|
91728943|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.12|||||TWO_SIDED|95.0|0.59|2.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.15|0.59|
91728944|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.52|0.87|
91728945|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.69|
91728946|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.79|||||TWO_SIDED|95.0|0.57|1.1||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.57|
91491176|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.718|TWO_SIDED|95.0|-0.72|0.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.50|-0.72|0.718
91528344|NCT02564055|182932066|OTHER||Difference in percentages|11.4|||||TWO_SIDED|95.0|-12.0|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||33.9|-12.0|
91491177|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.57|TWO_SIDED|95.0|-0.43|0.79|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.79|-0.43|0.570
91491178|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.343||0.384|TWO_SIDED|95.0|-0.97|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.38|-0.97|0.384
91491179|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.341||0.334|TWO_SIDED|95.0|-1.0|0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.34|-1.00|0.334
91491180|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.343||0.474|TWO_SIDED|95.0|-0.92|0.43|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.43|-0.92|0.474
91491181|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.381||0.445|TWO_SIDED|95.0|-1.04|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.46|-1.04|0.445
91491182|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.38||0.174|TWO_SIDED|95.0|-1.27|0.23|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.23|-1.27|0.174
91491183|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.383||0.217|TWO_SIDED|95.0|-1.23|0.28|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.28|-1.23|0.217
91728947|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|2.14|||||TWO_SIDED|95.0|1.52|3.02||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.02|1.52|
91728948|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.64|||||TWO_SIDED|95.0|1.16|2.3||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.30|1.16|
91728949|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.76|||||TWO_SIDED|95.0|0.51|1.14||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.14|0.51|
91728950|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|2.23|4.33||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.33|2.23|
91728951|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.17|0.61|
91728952|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.27|||||TWO_SIDED|95.0|0.19|0.4||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.40|0.19|
91728953|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratrio|1.82|||||TWO_SIDED|95.0|1.25|2.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.66|1.25|
91728954|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.91|1.94||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.91|
91728955|NCT01026038|183353465|SUPERIORITY_OR_OTHER||GMC ratio|0.73|||||TWO_SIDED|95.0|0.47|1.13||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.47|
91728956|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.23|1.76||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.76|0.23|
91728957|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.3|1.99||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.99|0.30|
91728958|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|0.38|3.86||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.86|0.38|
91728959|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.43|1.99||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.99|0.43|
91728960|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.54|2.22||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.22|0.54|
91528345|NCT02564055|182932066|OTHER||Difference in percentages|30.2|||||TWO_SIDED|95.0|6.8|51.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||51.0|6.8|
91491184|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.396||0.024|TWO_SIDED|95.0|-1.69|-0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.12|-1.69|0.024
91491185|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.396||0.01|TWO_SIDED|95.0|-1.81|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.24|-1.81|0.010
91491186|NCT01786668|182855091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.399||0.038|TWO_SIDED|95.0|-1.62|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.04|-1.62|0.038
91491187|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.15|STANDARD_ERROR_OF_MEAN|6.75||0.539|TWO_SIDED|95.0|-17.38|9.08|||Normal approximation for two proportions|||Week 2||9.08|-17.38|0.539
91491188|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 2||20.40|-9.46|0.473
91491189|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
91728961|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.79|0.50|
91728962|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.56|2.19||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.19|0.56|
91728963|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.58|2.06||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.06|0.58|
91728964|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.46|2.13||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.13|0.46|
91728965|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.38|2.55||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.55|0.38|
91728966|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.5|3.0||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.00|0.50|
91491190|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
91491191|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.51|STANDARD_ERROR_OF_MEAN|8.2||0.854|TWO_SIDED|95.0|-14.57|17.59|||Normal approximation for two proportions|||Week 4||17.59|-14.57|0.854
91728967|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.42|3.72||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.42|
91728968|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.29|1.68||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.29|
91728969|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.4|2.1||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.10|0.40|
91728970|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.49|3.64||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.64|0.49|
91728971|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.7|||||TWO_SIDED|95.0|0.7|4.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.12|0.70|
91758925|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.687||||0.9497|TWO_SIDED|95.0|0.79|9.143||1-sided unstratified log-rank test|Log Rank|||High PDGFRalpha expression||9.143|0.790|0.9497
91491192|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
91491193|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
91491194|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 8||22.92|-12.44|0.561
91491195|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 8||31.04|-5.17|0.162
91491196|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.62|STANDARD_ERROR_OF_MEAN|9.11||0.013|TWO_SIDED|95.0|4.76|40.49|||Normal approximation for two proportions|||Week 12||40.49|4.76|0.013
91491197|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
91528346|NCT02564055|182932066|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-19.4|26.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||26.6|-19.4|
91528347|NCT02564055|182932066|OTHER||Difference in percentages|17.4|||||TWO_SIDED|95.0|-6.0|39.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.5|-6.0|
91528348|NCT02564055|182932066|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-7.1|39.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||39.4|-7.1|
91528349|NCT02564055|182932066|OTHER||Difference in percentages|41.9|||||TWO_SIDED|95.0|19.2|61.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||61.2|19.2|
91528350|NCT02564055|182932066|OTHER||Difference in percentages|8.9|||||TWO_SIDED|95.0|-14.9|32.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||32.0|-14.9|
91697175|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.35|||||||t-test, 2 sided|||Isoferulic acid||||0.35
91728972|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.6|3.14||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.14|0.60|
91728973|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.3|2.21||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.21|0.30|
91728974|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.43|1.89||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.89|0.43|
91528351|NCT02564055|182932066|OTHER||Difference in percentages|16.3|||||TWO_SIDED|95.0|-7.3|38.3|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||38.3|-7.3|
91528352|NCT02564055|182932066|OTHER||Difference in percentages|13.4|||||TWO_SIDED|95.0|-11.3|36.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||36.5|-11.3|
91528353|NCT02564055|182932066|OTHER||Difference in percentages|30.8|||||TWO_SIDED|95.0|6.1|52.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||52.8|6.1|
91728975|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.83|||||TWO_SIDED|95.0|0.42|1.67||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.67|0.42|
91728976|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.4|2.16||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.16|0.40|
91728977|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|7.53|||||TWO_SIDED|95.0|2.86|19.78||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||19.78|2.86|
91728978|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.53|||||TWO_SIDED|95.0|0.22|1.31||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.22|
91728979|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.07|||||TWO_SIDED|95.0|0.02|0.21||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.21|0.02|
91528354|NCT02564055|182932066|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-3.0|44.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||44.9|-3.0|
91528355|NCT02564055|182932066|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-13.5|34.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||34.7|-13.5|
91528356|NCT02564055|182932066|OTHER||Difference in percentages|27.4|||||TWO_SIDED|95.0|2.5|49.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||49.9|2.5|
91528357|NCT02564055|182932066|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.0|40.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||40.7|-9.0|
91528358|NCT02564055|182932066|OTHER||Difference in percentages|29.5|||||TWO_SIDED|95.0|3.7|52.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||52.3|3.7|
91528359|NCT02564055|182932066|OTHER||Difference in percentages|5.7|||||TWO_SIDED|95.0|-20.1|30.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||30.9|-20.1|
91528360|NCT02564055|182932066|OTHER||Difference in percentages|9.3|||||TWO_SIDED|95.0|-16.2|33.8|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||33.8|-16.2|
91528361|NCT02564055|182932066|OTHER||Difference in percentages|12.6|||||TWO_SIDED|95.0|-13.4|37.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||37.3|-13.4|
91528362|NCT02564055|182932066|OTHER||Difference in percentages|27.0|||||TWO_SIDED|95.0|0.7|50.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||50.5|0.7|
91528363|NCT02564055|182932066|OTHER||Difference in percentages|0.4|||||TWO_SIDED|95.0|-25.6|25.6|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||25.6|-25.6|
91528364|NCT02564055|182932066|OTHER||Difference in percentages|2.6|||||TWO_SIDED|95.0|-22.6|27.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||27.6|-22.6|
91697176|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.52|||||||t-test, 2 sided|||Madecassic acid||||0.52
91697177|NCT03937908|183288279|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.13|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.13
91697178|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.34|||||||t-test, 2 sided|||Asiatic acid||||0.34
91728980|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.53|2.3||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.30|0.53|
91491198|NCT01786668|182855092|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
91491199|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.272||0.164|TWO_SIDED|95.0|-0.92|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.16|-0.92|0.164
91491200|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.271||0.129|TWO_SIDED|95.0|-0.95|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.95|0.129
91491201|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.272||0.66|TWO_SIDED|95.0|-0.66|0.42|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.42|-0.66|0.660
91491202|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.297||0.256|TWO_SIDED|95.0|-0.92|0.25|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.25|-0.92|0.256
91491203|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.296||0.048|TWO_SIDED|95.0|-1.17|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.00|-1.17|0.048
91491204|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.297||0.318|TWO_SIDED|95.0|-0.88|0.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.29|-0.88|0.318
91728981|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.5|1.97||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.50|
91728982|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.39|2.07||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.07|0.39|
91728983|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|4.2|||||TWO_SIDED|95.0|2.18|8.09||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||8.09|2.18|
91491205|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.35||0.522|TWO_SIDED|95.0|-0.92|0.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.47|-0.92|0.522
91491206|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|-1.38|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.00|-1.38|0.050
91491207|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.352||0.337|TWO_SIDED|95.0|-1.03|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.36|-1.03|0.337
91728984|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.33|1.13||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.33|
91728985|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.07|0.31||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.31|0.07|
91728986|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|1.51|6.4||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.40|1.51|
91491208|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.373||0.214|TWO_SIDED|95.0|-1.2|0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.27|-1.20|0.214
91728987|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.88|||||TWO_SIDED|95.0|0.96|3.69||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.69|0.96|
91697179|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.08
91697180|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Dihydroferulic acid||||0.23
91728988|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.6|||||TWO_SIDED|95.0|0.27|1.37||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.27|
91728989|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|2.88|||||TWO_SIDED|95.0|1.39|5.98||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.98|1.39|
91728990|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.58|2.28||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.28|0.58|
91728991|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.4|||||TWO_SIDED|95.0|0.17|0.92||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.92|0.17|
91728992|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|2.57|||||TWO_SIDED|95.0|1.5|4.39||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.39|1.50|
91728993|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.75|2.05||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.05|0.75|
91728994|NCT01026038|183353466|SUPERIORITY_OR_OTHER||GMC ratio|0.48|||||TWO_SIDED|95.0|0.26|0.89||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.89|0.26|
91728995|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.73||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.73|0.04|
91491209|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.372||0.011|TWO_SIDED|95.0|-1.69|-0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.22|-1.69|0.011
91491210|NCT01786668|182855093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.375||0.031|TWO_SIDED|95.0|-1.55|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-1.55|0.031
91728996|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.64||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.64|0.04|
91728997|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.19|5.46||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.46|0.19|
91728998|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.17|5.85||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.85|0.17|
91728999|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.15|3.72||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.15|
91729000|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.1|5.37||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.37|0.10|
91729001|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.25||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.25|0.23|
91758926|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.386||||0.0401|TWO_SIDED|95.0|0.127|1.173||1-sided unstratified log-rank test|Log Rank|||Low PDGFRalpha expression||1.173|0.127|0.0401
91758927|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.862||||0.3128|TWO_SIDED|95.0|0.487|1.524||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRalpha expression||1.524|0.487|0.3128
91758928|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.823||||0.365|TWO_SIDED|95.0|0.273|2.488||1-sided unstratified log-rank test|Log Rank|||High PDGFRbeta expression||2.488|0.273|0.3650
91758929|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.6105|TWO_SIDED|95.0|0.408|3.48||1-sided unstratified log-rank test|Log Rank|||Low PDGFRbeta expression||3.480|0.408|0.6105
91758930|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.3027|TWO_SIDED|95.0|0.488|1.502||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRbeta expression||1.502|0.488|0.3027
91758931|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.4436|TWO_SIDED|95.0|0.262|3.184||1-sided unstratified log-rank test|Log Rank|||High VEGF expression||3.184|0.262|0.4436
91758932|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.4582|TWO_SIDED|95.0|0.296|3.062||1-sided unstratified log-rank test|Log Rank|||Low VEGF expression||3.062|0.296|0.4582
91491211|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.106||0.982|TWO_SIDED|95.0|-0.21|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.21|-0.21|0.982
91528365|NCT02564055|182932066|OTHER||Difference in percentages|6.9|||||TWO_SIDED|95.0|-18.7|31.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||31.7|-18.7|
91491212|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.151|TWO_SIDED|95.0|-0.36|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.06|-0.36|0.151
91491213|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.106||0.205|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.07|-0.34|0.205
91491214|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.118||0.898|TWO_SIDED|95.0|-0.25|0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.22|-0.25|0.898
91491215|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.37|TWO_SIDED|95.0|-0.34|0.13|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.13|-0.34|0.370
91491216|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.119||0.288|TWO_SIDED|95.0|-0.36|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.11|-0.36|0.288
91729002|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.17|3.92||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.92|0.17|
91491217|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.242|TWO_SIDED|95.0|-0.42|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.11|-0.42|0.242
91491218|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.12|TWO_SIDED|95.0|-0.48|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.06|-0.48|0.120
91491219|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.031|TWO_SIDED|95.0|-0.56|-0.03|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.03|-0.56|0.031
91491220|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.157||0.28|TWO_SIDED|95.0|-0.48|0.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.14|-0.48|0.280
91491221|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.157||0.099|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.05|-0.57|0.099
91697181|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.14|||||||t-test, 2 sided|||Ferulic acid||||0.14
91491222|NCT01786668|182855094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.158||0.014|TWO_SIDED|95.0|-0.7|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-0.70|0.014
91491223|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.387||0.895|TWO_SIDED|95.0|-0.81|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.71|-0.81|0.895
91697182|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.28|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.28
91491224|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.386||0.033|TWO_SIDED|95.0|-1.59|-0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.07|-1.59|0.033
91491225|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.388||0.044|TWO_SIDED|95.0|-1.55|-0.02|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.02|-1.55|0.044
91491226|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.411||0.53|TWO_SIDED|95.0|-1.07|0.55|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.55|-1.07|0.530
91528366|NCT02564055|182932066|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.5|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.5|
91697183|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.17|||||||t-test, 2 sided|||Isoferulic acid||||0.17
91697184|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.98|||||||t-test, 2 sided|||Madecassic acid||||0.98
91697185|NCT03937908|183288280|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
91729003|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.11|4.43||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.43|0.11|
91729004|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|2.4|||||TWO_SIDED|95.0|0.48|12.35||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||12.35|0.48|
91729005|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.45|9.05||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.05|0.45|
91729006|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.13|5.14||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.14|0.13|
91729007|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.04|0.8||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.80|0.04|
91729008|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.12|2.03||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.12|
91729009|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|2.7|||||TWO_SIDED|95.0|0.48|14.92||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||14.92|0.48|
91729010|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.23|4.36||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.36|0.23|
91729011|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.31|4.84||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.84|0.31|
91729012|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.65||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||6.65|0.23|
91729013|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.17|4.17||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.17|0.17|
91729014|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.07|1.24||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.24|0.07|
91729015|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.06|2.08||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.08|0.06|
91729016|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.79|1.97||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.97|0.79|
91528367|NCT02564055|182932066|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-14.9|35.8|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||35.8|-14.9|
91729017|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.38|0.88||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.88|0.38|
91729018|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.27|0.77||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.77|0.27|
91729019|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.85|4.9||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.90|0.85|
91729020|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.49|2.48||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.48|0.49|
91528368|NCT02564055|182932066|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
91528369|NCT02564055|182932066|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
91528370|NCT02564055|182932066|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-32.2|57.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||57.9|-32.2|
91528371|NCT02564055|182932066|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
91528372|NCT02564055|182932073|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-45.8|32.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||32.5|-45.8|
91491227|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.411||0.114|TWO_SIDED|95.0|-1.46|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.16|-1.46|0.114
91491228|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.415||0.297|TWO_SIDED|95.0|-1.25|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.38|-1.25|0.297
91491229|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.37||0.377|TWO_SIDED|95.0|-1.06|0.4|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.40|-1.06|0.377
91491230|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.77|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.31|-1.77|0.006
91491231|NCT01786668|182855095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.017|TWO_SIDED|95.0|-1.64|-0.17|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.17|-1.64|0.017
91729021|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.2|1.45||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.45|0.20|
91729022|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.87|
91729023|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.79|
91729024|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.76|1.06||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.76|
91491232|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.414||0.8|TWO_SIDED|95.0|-0.92|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.71|-0.92|0.800
91491233|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.413||0.113|TWO_SIDED|95.0|-0.16|1.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||1.47|-0.16|0.113
91491234|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.414||0.064|TWO_SIDED|95.0|-1.59|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.05|-1.59|0.064
91491235|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.972|TWO_SIDED|95.0|-0.74|0.71|||Mixed Models Analysis|||Week 4||0.71|-0.74|0.972
91729025|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|16.5|||||TWO_SIDED|95.0|3.56|76.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||76.14|3.56|
91491236|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.368||0.44|TWO_SIDED|95.0|-0.44|1.01|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||1.01|-0.44|0.440
91491237|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.369||0.311|TWO_SIDED|95.0|-1.1|0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.35|-1.10|0.311
91528373|NCT02564055|182932073|OTHER||Difference in percentages|15.4|||||TWO_SIDED|95.0|-25.7|52.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 1 has been presented.|||52.6|-25.7|
91697186|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.04|||||||t-test, 2 sided|||Asiatic acid||||0.04
91697187|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Caffeic acid||||0.01
91697188|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.06|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.06
91697189|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydroferulic acid||||0.08
91729026|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|2.3|||||TWO_SIDED|95.0|0.56|9.06||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.06|0.56|
91697190|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.56|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.56
91491238|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.629||0.501|TWO_SIDED|95.0|-1.66|0.82|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.82|-1.66|0.501
91491239|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.629||0.543|TWO_SIDED|95.0|-1.63|0.86|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.86|-1.63|0.543
91697191|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.21|||||||t-test, 2 sided|||Ferulic acid||||0.21
91697192|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.05
91697193|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Isoferulic acid||||0.05
91697194|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Madecassic acid||||0.23
91697195|NCT03937908|183288281|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
91697196|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.7|||||||t-test, 2 sided|||Asiatic acid||||0.7
91697197|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||Madecassic acid||||0.09
91697198|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Asiaticoside||||0.4
91697199|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Madecassoside||||0.6
91697200|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.4
91697201|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.1
91697202|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.9
91697203|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.03|||||||t-test, 2 sided|||Caffeic acid||||0.03
91697204|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||Ferulic acid||||0.9
91697205|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Isoferulic acid||||0.6
91697206|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Dihydroferulic acid||||0.4
91697207|NCT03937908|183288282|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.8|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.8
91491240|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.636||0.287|TWO_SIDED|95.0|-1.93|0.57|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.57|-1.93|0.287
91697208|NCT03937908|183288283|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||1 hour||||0.1
91697209|NCT03937908|183288283|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||2 hours||||0.1
91697210|NCT03937908|183288283|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.3|||||||t-test, 1 sided|||3 hours||||0.3
91697211|NCT03937908|183288283|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||4 hours||||0.5
91697212|NCT03937908|183288283|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||6 hours||||0.5
91729027|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.78||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.02|
91491241|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.519||0.82|TWO_SIDED|95.0|-0.91|1.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.14|-0.91|0.820
91729028|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.22|7.07||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||7.07|0.22|
91729029|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.03|0.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.03|
91729030|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.84||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.84|0.02|
91729031|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|4.8|||||TWO_SIDED|95.0|1.35|16.98||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||16.98|1.35|
91729032|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.28|3.23||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.23|0.28|
91491242|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.711|TWO_SIDED|95.0|-0.83|1.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.22|-0.83|0.711
91697213|NCT03875092|183288284|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.24|0.52|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.52|0.24|
91729033|NCT01026038|183353467|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.05|0.85||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.85|0.05|
91729034|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.38||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.38|0.80|
91729035|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.76|
91729036|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.69|
91491243|NCT01786668|182855097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.524||0.424|TWO_SIDED|95.0|-1.45|0.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.61|-1.45|0.424
91697214|NCT03875092|183288285|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.28|0.7|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.70|0.28|
91697215|NCT03875092|183288286|OTHER||Difference in Percentage|36.7|||||TWO_SIDED|95.0|19.9|51.6|||||Based on unstratified Miettinen \& Nurminen method, due to small sample size.|||51.6|19.9|
91697216|NCT02163226|183288309|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
91729037|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.49|0.9||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.90|0.49|
91729038|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.55|1.01||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.01|0.55|
91729039|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.79|1.59||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.59|0.79|
91729040|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.98|1.63||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.63|0.98|
91729041|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.76|1.27||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.76|
91697217|NCT02163226|183288309|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
91697218|NCT02163226|183288309|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
91697219|NCT02163226|183288309|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
91697220|NCT02163226|183288309|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
91491244|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.203||0.785|TWO_SIDED|95.0|-0.34|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.46|-0.34|0.785
91491245|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.203||0.605|TWO_SIDED|95.0|-0.3|0.51|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.51|-0.30|0.605
91491246|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.204||0.175|TWO_SIDED|95.0|-0.68|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.68|0.175
91491247|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.232||0.482|TWO_SIDED|95.0|-0.29|0.62|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.62|-0.29|0.482
91697221|NCT02163226|183288309|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
91697222|NCT02163226|183288309|OTHER|2 sided p value||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
91697223|NCT02163226|183288309|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
91697224|NCT02163226|183288309|OTHER|2 sided p value||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
91697225|NCT02163226|183288309|OTHER|2 sided p value||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
91697226|NCT02163226|183288310|OTHER|2 sided p value||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
91697227|NCT02163226|183288310|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
91697228|NCT02163226|183288310|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
91697229|NCT02163226|183288310|OTHER|2 sided p valued||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
91491248|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.231||0.288|TWO_SIDED|95.0|-0.7|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.70|0.288
91697230|NCT02163226|183288310|OTHER|2 sided p valued||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
91697231|NCT02163226|183288310|OTHER|2 sided p valued||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
91697232|NCT02163226|183288310|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
91697233|NCT02163226|183288310|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
91697234|NCT02163226|183288310|OTHER|2 sided p value||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
91697235|NCT02163226|183288310|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
91528374|NCT02564055|182932073|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-46.0|32.6|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 1 has been presented.|||32.6|-46.0|
91697236|NCT01585324|183288313|SUPERIORITY_OR_OTHER|||||||0.8333|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.||||||0.8333
91697237|NCT01585324|183288315|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Fisher Exact|||||||0.0867
91697238|NCT01585324|183288317|SUPERIORITY_OR_OTHER|||||||0.6492|TWO_SIDED||||||ANCOVA|||||||0.6492
91697239|NCT01585324|183288319|SUPERIORITY_OR_OTHER|||||||0.0333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0333
91697240|NCT03625466|183288320|SUPERIORITY||Mean Difference|-1.5|||||TWO_SIDED|95.0|-5.5|2.6||||||||2.6|-5.5|
91697241|NCT01058993|183288330|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Student t-test-comparison means of normal subjects \& controls.||||||<0.05
91697242|NCT01058993|183288330|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Ratio paired t-test|Ratio paired t-test for comparison of baselines and responses for each category of leukocytes||The patients' leukocyte counts before and after plerixafor were compared.||||<0.05
91697243|NCT03214380|183288379|NON_INFERIORITY|Non-inferiority Margin = 0.4 for HbA1c|Least Square Mean Difference (LSMean)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
91697244|NCT03214380|183288380|SUPERIORITY||Mean Difference (Net)|-11.8|||<|0.001|TWO_SIDED|95.0|-18.1|-5.5|||ANCOVA|||||-5.5|-18.1|<0.001
91697245|NCT03214380|183288381|SUPERIORITY||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.3|-9.5|||ANCOVA|||||-9.5|-25.3|<0.001
91697246|NCT02230696|183288390|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.19|||||TWO_SIDED|90.0|84.77|104.52|||Trial and Error approach|||||104.52|84.77|
91697247|NCT02230696|183288391|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.68|||||TWO_SIDED|90.0|84.86|105.54|||Trial and Error approach|||||105.54|84.86|
91697248|NCT00614523|183288393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.13|TWO_SIDED|95.0|0.66|1.05|||Anderson-Gill model|Anderson-Gill model using the model-based variance estimate and stratified by the randomization stratification factors|Romiplostim /Placebo|||1.05|0.66|0.13
91697249|NCT00614523|183288394|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.766|||<|0.001|TWO_SIDED|95.0|0.66|0.88|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.88|0.66|<0.001
91697250|NCT00614523|183288395|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.922||||0.026|TWO_SIDED|95.0|0.86|0.99|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.99|0.86|0.026
91697251|NCT00614523|183288396|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.739|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||Poisson Regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.8|0.68|<0.001
91697252|NCT00614523|183288397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.001|TWO_SIDED|95.0|4.7|51.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for stratification factors.|Romiplostim /Placebo|||51.8|4.7|<0.001
91697253|NCT00614523|183288398|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.402||||0.032|TWO_SIDED|95.0|1.03|1.91|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||1.91|1.03|0.032
91697254|NCT00614523|183288402|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.639|||<|0.001|TWO_SIDED|95.0|0.57|0.71|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.71|0.57|<0.001
91697255|NCT00748189|183288475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.45|0.72|||Log Rank||Hazard ratios are obtained using the Pike estimator.|||0.72|0.45|<0.001
91697256|NCT00748189|183288478|OTHER||Hazard Ratio (HR)|0.88||||0.363|TWO_SIDED|95.0|0.65|1.17|||Log Rank||hazard ratios are obtained using the Pike estimator. A hazard ratio \<1 indicates a lower risk with O+CHL treatment compared with chlorambucil|||1.17|0.65|0.363
91697257|NCT00748189|183288491|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.71|||||TWO_SIDED|90.0|0.53|0.94|||||Ratio of Cmax/Dose is the ratio of dose-normalized chlorambucil Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.94|0.53|
91697258|NCT00748189|183288491|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.79|||||TWO_SIDED|90.0|0.63|0.99|||||Ratio of Cmax/Dose is the ratio of dose-normalized PAAM Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.99|0.63|
91697259|NCT00748189|183288492|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|1.04|||||TWO_SIDED|90.0|0.77|1.4|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized chlorambucil AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.40|0.77|
91697260|NCT00748189|183288492|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-inf) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-inf)/Dose|1.11|||||TWO_SIDED|90.0|0.82|1.5|||||Ratio of AUC(0-inf)/Dose is the ratio of dose-normalized chlorambucil AUC(0-inf) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.50|0.82|
91697261|NCT00748189|183288492|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|0.89|||||TWO_SIDED|90.0|0.72|1.1|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized PAAM AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.10|0.72|
91697262|NCT04481191|183288501|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.0|0.9||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||0.9|-4.0|< 0.001
91697263|NCT04481191|183288501|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||1.5|-4.3|< 0.001
91697264|NCT04481191|183288501|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|-1.6|3.0||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use % - Staggered-use %||3.0|-1.6|< 0.001
91697265|NCT01598090|183288515|NON_INFERIORITY|Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.||||||0.0855||||||Non-inferiority testing is based on lower limit of confidence interval.|Mantel Haenszel|||||||0.0855
91697266|NCT03628339|183288525|OTHER||% Ratio of Geometric Least square Mean|101.4|||||TWO_SIDED|90.0|89.35|115.06||||||||115.06|89.35|
91697267|NCT03628339|183288526|OTHER||% Ratio of Geometric Least square Mean|101.16|||||TWO_SIDED|90.0|89.24|114.66||||||||114.66|89.24|
91697268|NCT03628339|183288527|OTHER||% Ratio of Geometric Least square Mean|103.62|||||TWO_SIDED|90.0|86.91|123.56||||||||123.56|86.91|
91697269|NCT00355147|183288538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.69|TWO_SIDED||||||Mixed Models Analysis|Adjusted for site, strata, baseline score, randomized group, month and the group by month interaction|This score represents change from baseline to six months across the groups.|This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.||||0.69
91697270|NCT00355147|183288538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED|||||Adjusted for site, strata, baseline value, treatment group, month of assessment, treatment group x month, random subject effect|Mixed Models Analysis||This score represents change from baseline to three months across groups.|This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measure||||0.05
91729042|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.05||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.05|0.58|
91729043|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.21|0.67|
91729044|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.25||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.70|
91729045|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.73|1.46||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.46|0.73|
91729046|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.83|1.43||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.43|0.83|
91729047|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.70|
91729048|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.61|1.15||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.61|
91729049|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.51|1.15||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.51|
91729050|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.46|1.03||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.46|
91729051|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.56|1.44||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.44|0.56|
91729052|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.37||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.37|0.74|
91729053|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
91729054|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.29||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.29|0.63|
91729055|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|3.1|||||TWO_SIDED|95.0|2.4|4.06||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.06|2.40|
91729056|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.66|0.39|
91729057|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.12|0.22||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.22|0.12|
91729058|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.4|||||TWO_SIDED|95.0|1.11|1.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.78|1.11|
91729059|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.66|1.06||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.66|
91729060|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.45|
91729061|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.84|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.62|0.84|
91729062|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.87||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.87|0.45|
91729063|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.36|0.79||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.79|0.36|
91758933|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.372|TWO_SIDED|95.0|0.536|1.548||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF expression||1.548|0.536|0.3720
91729064|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.71|1.4||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.40|0.71|
91729065|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.66|1.31||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.66|
91697271|NCT00355147|183288539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.66|TWO_SIDED||||||Mixed Models Analysis|Adjusted by site, strata, baseline score, treatment group, month and group by month interaction|The score is the change from baseline to six months between groups.|||||0.66
91697272|NCT00355147|183288540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.74||||0.06|TWO_SIDED|95.0|0.88|51.31|||Regression, Logistic|||||51.31|0.88|0.06
91697273|NCT00355147|183288540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45||||0.036|TWO_SIDED|95.0|1.08|10.96|||Regression, Logistic|||Within group Intervention Pre Post Comparison Compliance with Diabetes Medication||10.96|1.08|0.036
91729066|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.39||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.63|
91729067|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.70|0.41|
91528375|NCT02564055|182932073|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-32.2|48.8|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 1 has been presented.|||48.8|-32.2|
91697274|NCT00355147|183288540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.7|||Regression, Logistic|||Within Group attention control group intervention pre post comparison compliance with Diabetes Medication||2.70|0.10|0.407
91697275|NCT00355147|183288541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|0.54|4.48|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Statin Medication||4.48|0.54|0.05
91697276|NCT00355147|183288541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98||||0.0001|TWO_SIDED|95.0|2.81|12.76|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Statin Medication||12.76|2.81|0.0001
91729068|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.82|1.38||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.38|0.82|
91729069|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|1.46|2.69||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.69|1.46|
91729070|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.28|0.74|
91491249|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.233||0.278|TWO_SIDED|95.0|-0.71|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.71|0.278
91491250|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.254||0.134|TWO_SIDED|95.0|-0.12|0.88|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.88|-0.12|0.134
91491251|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.254||0.397|TWO_SIDED|95.0|-0.29|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.72|-0.29|0.397
91491252|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.257||0.964|TWO_SIDED|95.0|-0.5|0.52|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.52|-0.50|0.964
91491253|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.269||0.155|TWO_SIDED|95.0|-0.15|0.91|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.91|-0.15|0.155
91491254|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.269||0.491|TWO_SIDED|95.0|-0.34|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.72|-0.34|0.491
91491255|NCT01786668|182855098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.271||0.515|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.36|-0.71|0.515
91491256|NCT01786668|182855099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|1.312||0.006|TWO_SIDED|95.0|1.06|6.24|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.24|1.06|0.006
91491257|NCT01786668|182855099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|1.305||0.004|TWO_SIDED|95.0|1.23|6.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.37|1.23|0.004
91491258|NCT01786668|182855099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|1.74|6.98|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.98|1.74|0.001
91729071|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.59|1.02||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.02|0.59|
91729072|NCT01026038|183353468|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.58|
91729073|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
91491259|NCT01786668|182855099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.857||0.857|TWO_SIDED|95.0|-4.0|3.33|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||3.33|-4.00|0.857
91491260|NCT01786668|182855099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|1.848||0.35|TWO_SIDED|95.0|-1.91|5.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.37|-1.91|0.350
91729074|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
91729075|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
91729076|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
91729077|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
91758934|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5586|TWO_SIDED|95.0|0.35|3.397||1-sided unstratified log-rank test|Log Rank|||High VEGF-C expression||3.397|0.350|0.5586
91729078|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.4|
91729079|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
91729080|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
91729081|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
91729082|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.6||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.7|
91729083|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.7|
91729084|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
91729085|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
91729086|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
91491261|NCT01786668|182855099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.876||0.49|TWO_SIDED|95.0|-2.4|5.0|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.00|-2.40|0.490
91491262|NCT01786668|182855100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.048||0.125|TWO_SIDED|95.0|-0.02|0.17|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.17|-0.02|0.125
91729087|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.4||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-6.6|
91491263|NCT01786668|182855100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.048||0.207|TWO_SIDED|95.0|-0.03|0.16|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.16|-0.03|0.207
91729088|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|-1.7|||||TWO_SIDED|95.0|-6.2|4.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-6.2|
91729089|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.1|||||TWO_SIDED|95.0|-4.8|7.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||7.5|-4.8|
91729090|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-4.8|9.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||9.5|-4.8|
91729091|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
91729092|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
91758935|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.842||||0.3652|TWO_SIDED|95.0|0.313|2.266||1-sided unstratified log-rank test|Log Rank|||Low VEGF-C expression||2.266|0.313|0.3652
91758936|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.3301|TWO_SIDED|95.0|0.493|1.554||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF-C expression||1.554|0.493|0.3301
91758937|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.5605|TWO_SIDED|95.0|0.331|3.636||1-sided unstratified log-rank test|Log Rank|||High VEGFR1 expression||3.636|0.331|0.5605
91758938|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.599||||0.2132|TWO_SIDED|95.0|0.16|2.236||1-sided unstratified log-rank test|Log Rank|||Low VEGFR1 expression||2.236|0.160|0.2132
91491264|NCT01786668|182855100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.049||0.013|TWO_SIDED|95.0|0.03|0.22|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.22|0.03|0.013
91697277|NCT00355147|183288541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0004|TWO_SIDED|95.0|1.83|8.01|||Regression, Logistic|||Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.||8.01|1.83|0.0004
91697278|NCT00355147|183288542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.096|TWO_SIDED|95.0|0.86|6.4|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Hypertension Medication||6.40|0.86|0.096
91697279|NCT00355147|183288542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.68||||0.0004|TWO_SIDED|95.0|1.81|7.48|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Hypertension Medication||7.48|1.81|0.0004
91697280|NCT00355147|183288542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.21|TWO_SIDED|95.0|0.77|3.21|||Regression, Logistic|||Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.||3.21|0.77|0.21
91697281|NCT01146379|183288543|SUPERIORITY_OR_OTHER|||||||0.01||||||a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons|Mixed Models Analysis|||The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.||||.01
91697282|NCT01146379|183288543|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||This analysis then asked which groups were different from the Low Movement Dose group||||.036
91697283|NCT01146379|183288543|SUPERIORITY_OR_OTHER|||||||0.679|||||||t-test, 2 sided|||This analysis asked if the Low Movement Dose group was different from the High Movement Dose group||||0.679
91697284|NCT01146379|183288543|SUPERIORITY_OR_OTHER|||||||0.209|||||||t-test, 2 sided|||This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group||||0.209
91697285|NCT03557931|183288544|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.02||0.858|TWO_SIDED|90.0|-1.51|1.88|||MMRM Method|||Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (least square (LS) Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 50 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 50 mg vs placebo is 0.035.|1.88|-1.51|0.858
91697286|NCT03557931|183288544|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-1.93|1.36|||0.775|||MMRM analysis model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 150 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 150 mg vs placebo is - 0.053.|1.36|-1.93|
91697287|NCT03557931|183288550|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|1.6||0.639|TWO_SIDED|90.0|-1.9|3.41|||ANCOVA|||Analysis of covariance (ANCOVA) model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||3.41|-1.90|0.639
91697288|NCT03557931|183288550|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|1.54||0.721|TWO_SIDED|90.0|-3.11|2.01|||ANCOVA|||ANCOVA model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||2.01|-3.11|0.721
91729093|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
91697289|NCT02805179|183288557|SUPERIORITY|Compared to historical controls||||||0.03|||||||1-sided binomial test|||||||0.03
91697290|NCT02157376|183288593|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the two-sided 95% confidence interval for the difference is larger than -0.05, the non-inferiority claim will be met.|Risk Difference (RD)|1.9||||0.393|TWO_SIDED|95.0|-2.8|6.5|||Pearson's Chi-square||The difference in treatment group percentages is given by Cimetidine minus Esomeprazole.|Assuming a bleeding percent of 6.3% for the active comparator, a risk reduction of 3.7% for esomeprazole, and a 5% non-inferiority margin, 150 patients per treatment arm will provide 94% power to demonstrate non-inferiority. The null hypothesis is that the bleeding rate for iv esomeprazole 40 mg bid exceeds the rate for iv cimetidine by an amount at least as large as 5%.||6.5|-2.8|0.393
91697291|NCT02703467|183288618|SUPERIORITY||||||>|0.05||||||calculated|t-test, 2 sided|||||||>0.05
91697292|NCT02729051|183288657|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.|Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.0161|||TWO_SIDED|95.0|-0.013|0.05|||||MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.|||0.050|-0.013|
91697293|NCT02729051|183288658|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.71|1.2|||||Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.|||1.20|0.71|
91697294|NCT02729051|183288659|OTHER||Least Square Mean Difference|-0.906|STANDARD_ERROR_OF_MEAN|0.8327|||TWO_SIDED|95.0|-2.54|0.728|||||Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.|||0.728|-2.540|
91729094|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.4||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.5|
91729095|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.6|
91729096|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-6.5|
91729097|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-1.7|9.6||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||9.6|-1.7|
91729098|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.2||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.2|-3.7|
91729099|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|-1.8|||||TWO_SIDED|95.0|-9.6|4.5||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-9.6|
91729100|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-2.0|11.3||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||11.3|-2.0|
91729101|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.9|5.6||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||5.6|-4.9|
91729102|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|-3.6|||||TWO_SIDED|95.0|-12.5|3.2||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||3.2|-12.5|
91729103|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
91729104|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
91491265|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|1.232||0.163|TWO_SIDED|95.0|-0.71|4.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||4.15|-0.71|0.163
91491266|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.232||0.955|TWO_SIDED|95.0|-2.36|2.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.50|-2.36|0.955
91491267|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.237||0.826|TWO_SIDED|95.0|-2.17|2.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.71|-2.17|0.826
91729105|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.6||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.6|
91729106|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
91729107|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.6||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.5|
91729108|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.7||||||Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-6.5|
91729109|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.7||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.6|
91729110|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
91729111|NCT01026038|183353471|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
91729112|NCT03782103|183353490|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|-0.2845|||||TWO_SIDED|95.0|-0.6033|0.0334||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.0334|-0.6033|
91729113|NCT03782103|183353490|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|2.8535|||||TWO_SIDED|95.0|2.5415|3.1655||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||3.1655|2.5415|
91729114|NCT03782103|183353491|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|0.0577|||||TWO_SIDED|95.0|-0.1457|0.2611||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.2611|-0.1457|
91729115|NCT03782103|183353491|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.8208|||||TWO_SIDED|95.0|1.6153|2.0264||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.0264|1.6153|
91729116|NCT01712074|183353525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.695|STANDARD_ERROR_OF_MEAN|0.8697||0.4256|TWO_SIDED|80.0|-0.424|1.814|||Mixed Models Analysis|||||1.814|-0.424|0.4256
91491268|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|1.322||0.246|TWO_SIDED|95.0|-1.07|4.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||4.14|-1.07|0.246
91729117|NCT01712074|183353526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.194|STANDARD_ERROR_OF_MEAN|1.7149||0.2027|TWO_SIDED|80.0|-0.013|4.401|||Mixed Models Analysis|||||4.401|-0.013|0.2027
91729118|NCT03478787|183353549|NON_INFERIORITY|Non-inferiority is met if the lower bound of the 96.25% confidence interval (CI) of adjusted treatment difference is above -12%.|Adjusted percentage difference|8.2|||||TWO_SIDED|96.25|-2.2|18.6|||||Across the strata, 96.25% confidence interval (CI) for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||18.6|-2.2|
91491269|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.318||0.467|TWO_SIDED|95.0|-1.64|3.56|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||3.56|-1.64|0.467
91729119|NCT03478787|183353550|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.8|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.8|< 0.001
91729120|NCT03478787|183353551|SUPERIORITY||Adjusted percentage difference|26.2|||<|0.001|TWO_SIDED|95.0|15.9|36.5||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||36.5|15.9|< 0.001
91729121|NCT03478787|183353552|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.9|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.9|< 0.001
91491270|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.328||0.948|TWO_SIDED|95.0|-2.53|2.7|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||2.70|-2.53|0.948
91729122|NCT03478787|183353553|SUPERIORITY||Adjusted percentage difference|20.0|||<|0.001|TWO_SIDED|95.0|11.7|28.3||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||28.3|11.7|< 0.001
91729123|NCT02792257|183353556|SUPERIORITY||Difference in slopes|-0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.328|-0.152|||Regression, Linear||standard error NOT standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||-0.152|-1.328|.015
91491271|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.479||0.255|TWO_SIDED|95.0|-1.23|4.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.61|-1.23|0.255
91491272|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.479||0.187|TWO_SIDED|95.0|-0.96|4.87|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.87|-0.96|0.187
91729124|NCT02792257|183353557|SUPERIORITY||Difference in slopes|-1.26|STANDARD_ERROR_OF_MEAN|0.75||0.094|TWO_SIDED|95.0|-2.73|0.21|||Regression, Linear||standard error not standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||0.21|-2.73|.094
91729125|NCT02792257|183353558|SUPERIORITY||Incident rate ratio|1.14|STANDARD_ERROR_OF_MEAN|0.26||0.57|TWO_SIDED|95.0|0.73|1.79|||Regression, Logistic|The original analytic plan called for a logistic regression of ever/never SAE as a function of treatment assignment.|not standard error of the mean just standard error.|||1.79|0.73|.57
91729126|NCT01245049|183353674|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|0.56|||||TWO_SIDED|95.0|-3.55|3.14|||Standardized asymptotic|||Non-inferiority in terms of booster response to D||3.14|-3.55|
91729127|NCT01245049|183353674|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups' difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|1.7|||||TWO_SIDED|95.0|-2.43|4.9||||||Non-inferiority in terms of booster response to T||4.9|-2.43|
91729128|NCT01245049|183353676|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.|Difference in adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.65|1.28|||ANCOVA|||Immune response difference to anti-Polio 1 antigen||1.28|0.65|
91729129|NCT01245049|183353676|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|0.78|||||TWO_SIDED|95.0|0.54|1.12|||ANCOVA|||Immune response difference to anti-Polio 2 antigen||1.12|0.54|
91729130|NCT01245049|183353676|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|1.3|||||TWO_SIDED|95.0|0.93|1.84|||ANCOVA|||Immune response difference to anti-Polio 3 antigen||1.84|0.93|
91729131|NCT01197300|183353723|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|3.7||||0.8505|TWO_SIDED|95.0|-37.242|44.642||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 18||44.642|-37.242|0.8505
91729132|NCT01197300|183353723|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|21.752||||0.218|TWO_SIDED|95.0|-14.126|57.63||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 24||57.630|-14.126|0.2180
91491273|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.497||0.373|TWO_SIDED|95.0|-1.62|4.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.29|-1.62|0.373
91729133|NCT01197300|183353724|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|2.36||||0.3544|TWO_SIDED|95.0|-2.886|7.606||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 18||7.606|-2.886|0.3544
91729134|NCT01197300|183353724|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|1.179||||0.705|TWO_SIDED|95.0|-5.281|7.639||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 24||7.639|-5.281|0.7050
91729135|NCT01197300|183353725|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|121.129||||0.531|TWO_SIDED|95.0|-291.0|533.258||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 18||533.258|-291.000|0.5310
91758939|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.3605|TWO_SIDED|95.0|0.53|1.537||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR1 expression||1.537|0.530|0.3605
91491274|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.643||0.313|TWO_SIDED|95.0|-1.58|4.9|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||4.90|-1.58|0.313
91491275|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|1.642||0.017|TWO_SIDED|95.0|0.71|7.19|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.19|0.71|0.017
91491276|NCT01786668|182855101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51|STANDARD_ERROR_OF_MEAN|1.66||0.007|TWO_SIDED|95.0|1.23|7.78|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.78|1.23|0.007
91491277|NCT03068455|182855107|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.04|0.78|
91491278|NCT03068455|182855108|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.75|1.14|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.14|0.75|
91491279|NCT03068455|182855109|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.32|0.80|
91491280|NCT03068455|182855110|SUPERIORITY||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.85|1.73|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.73|0.85|
91697295|NCT02729051|183288660|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.|||1.25|0.72|
91697296|NCT02729051|183288661|OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.1773|||TWO_SIDED|95.0|-0.211|0.485|||||Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.|||0.485|-0.211|
91697297|NCT02729051|183288662|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Analysis was performed using a Cox proportional hazards model.|||1.12|0.68|
91697298|NCT02702388|183288663|NON_INFERIORITY|Odds ratio of ORR as of Week 24 response (18 mg vs 24 mg) along with its 95% confidence interval (CI) using the Cochran-Mantel-Haenszel (CMH) method, stratified by the randomization stratification factors. The test was performed per the 95% CI using the noninferiority margin of 0.4. Noninferiority will be declared if the lower limit of the 95% CI for the odds ratio is greater than 0.4.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
91697299|NCT00596817|183288696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.0035|TWO_SIDED|95.0|1.26|3.21|||Cox-model|Cox-model using an exact method to handle ties||||3.21|1.26|0.0035
91697300|NCT00596817|183288697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.001|TWO_SIDED|95.0|1.35|3.23||A nominal p-value is provided.|Cox-Model|||||3.23|1.35|0.0010
91697301|NCT00596817|183288698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.66||0.002|TWO_SIDED|95.0|-3.36|-0.77||A nominal p-value is provided.|ANCOVA|||||-0.77|-3.36|0.0020
91758940|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.4438|TWO_SIDED|95.0|0.304|2.784||1-sided unstratified log-rank test|Log Rank|||High VEGFR2 expression||2.784|0.304|0.4438
91491281|NCT03068455|182855111|SUPERIORITY|\< 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.73|1.14|||||Unstratisfied HR, Nivolumab over Ipilimumab|||1.14|0.73|
91491282|NCT03068455|182855111|SUPERIORITY|\>= 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.18|0.76|
91697302|NCT00596817|183288699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.55||0.0171|TWO_SIDED|95.0|-2.39|-0.24||A nominal p-value is provided.|ANCOVA|||||-0.24|-2.39|0.0171
91758941|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.122||||0.5699|TWO_SIDED|95.0|0.403|3.125||1-sided unstratified log-rank test|Log Rank|||Low VEGFR2 expression||3.125|0.403|0.5699
91491283|NCT03068455|182855111|SUPERIORITY|\>= 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.71|1.34|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.34|0.71|
91491284|NCT03068455|182855111|SUPERIORITY|\< 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.10|0.77|
91491285|NCT03068455|182855111|SUPERIORITY|Non-quantifiable Tumor PD-L1 Expression|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.38|1.51|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.51|0.38|
91491286|NCT00692341|182855125|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|88.61|||||TWO_SIDED|90.0|49.2|159.56||||||For mild hepatic impairment, analysis of variance (ANOVA) was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and confidence intervals (CIs) on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||159.56|49.20|
91697303|NCT00596817|183288700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.6||0.0612|TWO_SIDED|95.0|-2.3|0.05||A nominal p-value is provided.|ANCOVA|||||0.05|-2.30|0.0612
91697304|NCT00596817|183288701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18||A nominal p-value is provided.|ANCOVA|||||-0.18|-0.57|0.0002
91697305|NCT00596817|183288702|SUPERIORITY_OR_OTHER||Difference|6.35||||0.025|TWO_SIDED|95.0|1.13|11.56||A nominal p-value is provided.|Fisher Exact|||||11.56|1.13|0.025
91697306|NCT00596817|183288703|SUPERIORITY_OR_OTHER||Difference|12.13||||0.002|TWO_SIDED|95.0|4.73|19.52||A nominal p-value is provided.|Fisher Exact|||||19.52|4.73|0.002
91697307|NCT00596817|183288704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.73||0.3642|TWO_SIDED|95.0|-2.12|0.78||A nominal p-value is provided.|ANCOVA|||||0.78|-2.12|0.3642
91697308|NCT00869622|183288706|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||||||0.0229
91697309|NCT01314872|183288728|SUPERIORITY_OR_OTHER||Difference in least squares (LS) means|-0.46||||0.056|TWO_SIDED|95.0|-0.92|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.01|-0.92|0.056
91697310|NCT01314872|183288728|SUPERIORITY_OR_OTHER||Difference in LS means|-0.45||||0.064|TWO_SIDED|95.0|-0.93|0.03|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.03|-0.93|0.064
91491287|NCT00692341|182855125|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|127.67|||||TWO_SIDED|90.0|70.9|229.91||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.91|70.90|
91491288|NCT00692341|182855126|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.34|||||TWO_SIDED|90.0|39.92|153.75||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||153.75|39.92|
91491289|NCT00692341|182855126|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|195.25|||||TWO_SIDED|90.0|99.49|383.18||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||383.18|99.49|
91491290|NCT00692341|182855127|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.14|||||TWO_SIDED|90.0|38.68|157.82||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||157.82|38.68|
91491291|NCT00692341|182855127|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|198.9|||||TWO_SIDED|90.0|98.47|401.74||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||401.74|98.47|
91697311|NCT01314872|183288728|SUPERIORITY_OR_OTHER||Difference in LS means|-0.64||||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.18|-1.11|0.007
91697312|NCT01314872|183288728|SUPERIORITY_OR_OTHER||Difference in LS means|-0.91|||<|0.001|TWO_SIDED|95.0|-1.37|-0.44|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.44|-1.37|< 0.001
91729136|NCT01197300|183353725|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|65.674||||0.7347|TWO_SIDED|95.0|-344.067|475.415||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 24||475.415|-344.067|0.7347
91729137|NCT01197300|183353726|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-147.68||||0.4143|TWO_SIDED|95.0|-394.41|99.049||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 18||99.049|-394.410|0.4143
91491292|NCT00692341|182855132|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|73.78|||||TWO_SIDED|90.0|37.4|145.56||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||145.56|37.40|
91729138|NCT01197300|183353726|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-132.437||||0.1266|TWO_SIDED|95.0|-286.452|21.579||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 24||21.579|-286.452|0.1266
91758942|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3147|TWO_SIDED|95.0|0.489|1.528||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR2 expression||1.528|0.489|0.3147
91491293|NCT00692341|182855132|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.86|||||TWO_SIDED|90.0|55.58|183.02||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||183.02|55.58|
91491294|NCT00692341|182855133|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.43|||||TWO_SIDED|90.0|44.75|186.79||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||186.79|44.75|
91697313|NCT01314872|183288728|SUPERIORITY_OR_OTHER||Difference in LS means|-0.54||||0.026|TWO_SIDED|95.0|-1.02|-0.07|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.07|-1.02|0.026
91758943|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002||||0.5015|TWO_SIDED|95.0|0.281|3.581||1-sided unstratified log-rank test|Log Rank|||High VEGFR3 expression||3.581|0.281|0.5015
91697314|NCT01314872|183288733|SUPERIORITY_OR_OTHER||Difference in LS means|-0.28||||0.167|TWO_SIDED|95.0|-0.68|0.12|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.12|-0.68|0.167
91697315|NCT01314872|183288733|SUPERIORITY_OR_OTHER||Difference in LS means|-0.57||||0.005|TWO_SIDED|95.0|-0.97|-0.17|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.17|-0.97|0.005
91697316|NCT01314872|183288733|SUPERIORITY_OR_OTHER||Difference in LS means|-0.72|||<|0.001|TWO_SIDED|95.0|-1.11|-0.33|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.33|-1.11|< 0.001
91697317|NCT01314872|183288733|SUPERIORITY_OR_OTHER||Difference in LS means|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.32|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.32|-1.10|< 0.001
91697318|NCT01314872|183288733|SUPERIORITY_OR_OTHER||Difference in LS means|-0.46||||0.03|TWO_SIDED|95.0|-0.87|-0.04|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.04|-0.87|0.030
91697319|NCT01314872|183288734|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.18||||0.401|TWO_SIDED|95.0|-0.61|0.25|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.25|-0.61|0.401
91697320|NCT01314872|183288734|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48||||0.029|TWO_SIDED|95.0|-0.91|-0.05|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.05|-0.91|0.029
91697321|NCT01314872|183288734|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.005|TWO_SIDED|95.0|-1.02|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.18|-1.02|0.005
91697322|NCT01314872|183288734|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58||||0.007|TWO_SIDED|95.0|-1.01|-0.16|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.16|-1.01|0.007
91697323|NCT01314872|183288734|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.14|TWO_SIDED|95.0|-0.78|0.11|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.11|-0.78|0.140
91697324|NCT01314872|183288735|SUPERIORITY_OR_OTHER||Difference in LS means|-0.18||||0.598|TWO_SIDED|95.0|-0.84|0.49|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.49|-0.84|0.598
91758944|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005||||0.4887|TWO_SIDED|95.0|0.334|3.025||1-sided unstratified log-rank test|Log Rank|||Low VEGFR3 expression||3.025|0.334|0.4887
91758945|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.818||||0.2432|TWO_SIDED|95.0|0.473|1.414||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR3 expression||1.414|0.473|0.2432
91758946|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446||||0.2321|TWO_SIDED|95.0|0.048|4.101||1-sided unstratified log-rank test|Log Rank|||Detected FGF expression||4.101|0.048|0.2321
91697325|NCT01314872|183288735|SUPERIORITY_OR_OTHER||Difference in LS means|-0.67||||0.052|TWO_SIDED|95.0|-1.35|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.01|-1.35|0.052
91528376|NCT02564055|182932073|OTHER||Difference in percentages|-24.2|||||TWO_SIDED|95.0|-60.8|14.8|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 2 has been presented.|||14.8|-60.8|
91697326|NCT01314872|183288735|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76||||0.024|TWO_SIDED|95.0|-1.43|-0.1|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.10|-1.43|0.024
91697327|NCT01314872|183288735|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.9|-0.58|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.58|-1.90|< 0.001
91697328|NCT01314872|183288735|SUPERIORITY_OR_OTHER||Difference in LS means|-0.94||||0.007|TWO_SIDED|95.0|-1.62|-0.26|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.26|-1.62|0.007
91697329|NCT01314872|183288736|SUPERIORITY_OR_OTHER||Difference in LS means|-0.49|||||TWO_SIDED|95.0|-1.0|0.03||||||||0.03|-1.00|
91697330|NCT01314872|183288736|SUPERIORITY_OR_OTHER||Difference in LS means|-1.1|||||TWO_SIDED|95.0|-1.62|-0.58||||||||-0.58|-1.62|
91697331|NCT01314872|183288737|SUPERIORITY_OR_OTHER||Difference in LS means|-0.29|||||TWO_SIDED|95.0|-0.71|0.13||||||||0.13|-0.71|
91697332|NCT01314872|183288737|SUPERIORITY_OR_OTHER||Difference in LS means|-0.21|||||TWO_SIDED|95.0|-0.64|0.21||||||||0.21|-0.64|
91697333|NCT01314872|183288738|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.56|0.43||||||||0.43|-0.56|
91697334|NCT01314872|183288738|SUPERIORITY_OR_OTHER||Difference in LS means|0.02|||||TWO_SIDED|95.0|-0.48|0.51||||||||0.51|-0.48|
91697335|NCT01314872|183288739|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76|||||TWO_SIDED|95.0|-1.45|-0.08||||||||-0.08|-1.45|
91697336|NCT01314872|183288739|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||||TWO_SIDED|95.0|-1.93|-0.56||||||||-0.56|-1.93|
91697337|NCT00860249|183288770|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
91697338|NCT00860249|183288771|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We intended to use a Bonferroni calculation to adjust for multiple comparisons among study arms.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
91697339|NCT02579343|183288802|SUPERIORITY|||||||0.05||||||P-value above was calculated. Does not reference threshold for clinical significance.|Repeated Measures Analysis of Variance|||||||.05
91697340|NCT02579343|183288803|SUPERIORITY|||||||0.05|||||||Repeated Measures Analysis of Variance|||||||.05
91697341|NCT04984278|183288804|SUPERIORITY||Combined least mean square difference|-0.29|STANDARD_ERROR_OF_MEAN|0.092|=|0.0048|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|=0.0048
91491295|NCT00692341|182855133|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|50.78|||||TWO_SIDED|90.0|27.14|95.03||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||95.03|27.14|
91491296|NCT00692341|182855134|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.09|||||TWO_SIDED|90.0|51.53|206.22||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||206.22|51.53|
91528377|NCT02564055|182932073|OTHER||Difference in percentages|28.5|||||TWO_SIDED|95.0|-13.7|63.0|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 2 has been presented.|||63.0|-13.7|
91697342|NCT05406479|183288855|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-5.146|4.76||||||Adults||4.76|-5.146|
91697343|NCT05406479|183288855|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|10.556|||||TWO_SIDED|95.0|0.926|20.185||||||Adolescents (13-17)||20.185|0.926|
91697344|NCT05406479|183288855|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|2.076|||||TWO_SIDED|95.0|-3.374|7.525||||||Children (5-12)||7.525|-3.374|
91697345|NCT04932655|183288877|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|103.22|||||TWO_SIDED|90.0|96.88|109.98||||||||109.98|96.88|
91697346|NCT04932655|183288877|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|109.64|||||TWO_SIDED|90.0|102.9|116.82||||||||116.82|102.9|
91697347|NCT04932655|183288877|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|102.9|||||TWO_SIDED|90.0|96.57|109.64||||||||109.64|96.57|
91697348|NCT04932655|183288878|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.47|||||TWO_SIDED|90.0|96.33|100.65||||||||100.65|96.33|
91729139|NCT01197300|183353727|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-17.691||||0.2123|TWO_SIDED|95.0|-41.925|6.543||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 18||6.543|-41.925|0.2123
91729140|NCT01197300|183353727|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-3.662||||0.4852|TWO_SIDED|95.0|-21.479|14.155||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 24||14.155|-21.479|0.4852
91729141|NCT01197300|183353728|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-4.661||||0.9009|TWO_SIDED|95.0|-16.647|7.325||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 18||7.325|-16.647|0.9009
91729142|NCT01197300|183353728|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-2.558||||0.9472|TWO_SIDED|95.0|-8.864|3.747||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 24||3.747|-8.864|0.9472
91758947|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7143|TWO_SIDED|95.0|0.526|3.292||1-sided unstratified log-rank test|Log Rank|||No detected FGF expression||3.292|0.526|0.7143
91697349|NCT04932655|183288878|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.88|||||TWO_SIDED|90.0|96.74|101.07||||||||101.07|96.74|
91758948|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.844||||0.2812|TWO_SIDED|95.0|0.486|1.465||1-sided unstratified log-rank test|Log Rank|||Indeterminate FGF expression||1.465|0.486|0.2812
91697350|NCT04932655|183288878|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.32|||||TWO_SIDED|90.0|98.15|102.54||||||||102.54|98.15|
91491297|NCT00692341|182855134|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|76.06|||||TWO_SIDED|90.0|41.41|139.73||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||139.73|41.41|
91491298|NCT00692341|182855135|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|109.38|||||TWO_SIDED|90.0|53.54|223.47||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||223.47|53.54|
91528378|NCT02564055|182932073|OTHER||Difference in percentages|-33.3|||||TWO_SIDED|95.0|-67.4|6.1|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 2 has been presented.|||6.1|-67.4|
91697351|NCT04932655|183288879|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.5|||||TWO_SIDED|90.0|96.33|100.71||||||||100.71|96.33|
91697352|NCT04932655|183288879|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|99.03|||||TWO_SIDED|90.0|96.85|101.26||||||||101.26|96.85|
91697353|NCT04932655|183288879|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.25|||||TWO_SIDED|90.0|98.05|102.5||||||||102.50|98.05|
91697354|NCT00379080|183288896|OTHER|||||||0.04|||||||Regression, Cox|||VEGFR2||||0.04
91697355|NCT00379080|183288896|OTHER|||||||0.04|||||||Regression, Cox|||PIGF||||0.04
91697356|NCT00379080|183288896|OTHER|||||||0.02|||||||Regression, Cox|||CAIX||||0.02
91697357|NCT00379080|183288896|OTHER|||||||0.05|||||||Regression, Cox|||sFLT\_1||||0.05
91697358|NCT00379080|183288896|OTHER|||||||0.01|||||||Regression, Cox|||sFLT\_1||||0.01
91697359|NCT00379080|183288896|OTHER|||||||0.05|||||||Regression, Cox|||VEGFR2||||0.05
91697360|NCT01089608|183288897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.01||||0.072|TWO_SIDED|95.0|-16.3|0.28|||Mixed Models Analysis|||||0.28|-16.30|0.072
91697361|NCT06175026|183288905|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.13|1.37||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health messages would not elicit different levels of perceived message effectiveness compared to the neutral messages.||1.37|1.13|<0.001
91697362|NCT06175026|183288905|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.03|1.26||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the environment messages would not elicit different perceived message effectiveness than the control messages.||1.26|1.03|<.001
91697363|NCT06175026|183288905|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.17|1.41||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health and environment messages would not elicit different perceived message effectiveness than the control messages.||1.41|1.17|<0.001
91697364|NCT06175026|183288905|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.062||0.1892|TWO_SIDED|95.0|-0.018|0.223||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.223|-0.018|.1892
91697365|NCT06175026|183288905|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.62||0.47|TWO_SIDED|95.0|-0.17|0.08||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.08|-.17|.47
91697366|NCT06175026|183288905|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.051|TWO_SIDED|95.0|-0.27|-0.03||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||-.03|-.27|.051
91697367|NCT01028014|183288909|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
91697368|NCT01028014|183288910|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
91528379|NCT02564055|182932073|OTHER||Difference in percentages|-0.9|||||TWO_SIDED|95.0|-40.7|40.7|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 2 has been presented.|||40.7|-40.7|
91697369|NCT00425061|183288921|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-5.2||||0.612|TWO_SIDED|95.0|-25.6|15.2|||ANCOVA|||Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid \[ICS\] only or ICS plus LABA) and treatment as two factors.||15.2|-25.6|0.612
91697370|NCT00425061|183288923|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.482|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.482
91697371|NCT00425061|183288923|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.492|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.492
91697372|NCT00425061|183288923|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.323|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.323
91697373|NCT00425061|183288923|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.226|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.226
91697374|NCT00425061|183288923|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.256|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.256
91697375|NCT00425061|183288924|SUPERIORITY_OR_OTHER||LS mean difference|1.8||||0.09|TWO_SIDED|95.0|-0.3|3.9|||ANCOVA|||Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||3.9|-0.3|0.090
91697376|NCT00425061|183288924|SUPERIORITY_OR_OTHER||LS mean difference|2.1||||0.144|TWO_SIDED|95.0|-0.8|5.0|||ANCOVA|||Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||5.0|-0.8|0.144
91697377|NCT00425061|183288926|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.354|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.4|0.354
91697378|NCT00425061|183288926|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.9|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.900
91697379|NCT00425061|183288926|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.921|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.921
91729143|NCT01197300|183353729|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-1.482||||0.46|TWO_SIDED|95.0|-3.805|0.841||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 18||0.841|-3.805|0.4600
91697380|NCT00425061|183288926|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.388|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.6|-0.2|0.388
91758949|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.6504|TWO_SIDED|95.0|0.248|7.96||1-sided unstratified log-rank test|Log Rank|||Detected FLT3 expression||7.960|0.248|0.6504
91528380|NCT02564055|182932073|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
91697381|NCT00425061|183288926|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.249|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.7|-0.2|0.249
91697382|NCT00425061|183288927|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Chi-squared|||||||0.267
91697383|NCT00425061|183288928|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Chi-squared|||||||0.029
91697384|NCT02111577|183288951|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)|Hazard Ratio (HR)|1.042||||0.596|TWO_SIDED|95.0|0.895|1.213|||Log Rank|||Stratified||1.213|0.895|0.596
91697385|NCT02111577|183288951|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.648|TWO_SIDED|95.0|0.891|1.204|||Log Rank|||Unstratified||1.204|0.891|0.648
91697386|NCT02111577|183288952|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.908||||0.335|TWO_SIDED|95.0|0.746|1.105|||Log Rank|||Stratified||1.105|0.746|0.335
91697387|NCT02111577|183288952|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.192|TWO_SIDED|95.0|0.725|1.067|||Log Rank|||Unstratified||1.067|0.725|0.192
91697388|NCT02111577|183288953|SUPERIORITY|Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.312||||0.071|TWO_SIDED|95.0|0.976|1.762|||Log Rank|||Stratified||1.762|0.976|0.071
91697389|NCT02111577|183288953|SUPERIORITY||Hazard Ratio (HR)|1.283||||0.09|TWO_SIDED|95.0|0.961|1.712|||Log Rank|||Unstratified||1.712|0.961|0.09
91697390|NCT02111577|183288954|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.461||||0.049|TWO_SIDED|95.0|1.0|2.134|||Log Rank|||Stratified||2.134|1|0.049
91697391|NCT02111577|183288954|SUPERIORITY||Hazard Ratio (HR)|1.436||||0.053|TWO_SIDED|95.0|0.993|2.077|||Log Rank|||Unstratified||2.077|0.993|0.053
91697392|NCT02111577|183288955|SUPERIORITY|Stratified by region (US vs other) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.938||||0.501|TWO_SIDED|95.0|0.779|1.13|||Log Rank|||Stratified||1.13|0.779|0.501
91697393|NCT02111577|183288955|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.512|TWO_SIDED|95.0|0.781|1.131|||Log Rank|||Unstratified||1.131|0.781|0.512
91697394|NCT02111577|183288956|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.99||||0.886|TWO_SIDED|95.0|0.863|1.136|||Log Rank|||Stratified||1.136|0.863|0.886
91491299|NCT00692341|182855135|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|196.92|||||TWO_SIDED|90.0|105.23|368.49||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||368.49|105.23|
91491300|NCT00692341|182855136|SUPERIORITY_OR_OTHER||Adjusted ratio of geometric means|111.65|||||TWO_SIDED|90.0|54.35|229.37||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.37|54.35|
91491301|NCT00692341|182855136|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|200.6|||||TWO_SIDED|90.0|106.68|377.2||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||377.20|106.68|
91491302|NCT00692341|182855137|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.82|||||TWO_SIDED|90.0|58.22|195.99||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||195.99|58.22|
91491303|NCT00692341|182855137|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|128.76|||||TWO_SIDED|90.0|75.62|219.25||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||219.25|75.62|
91491304|NCT00702689|182855144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Paired t-test|||||||.011
91491305|NCT00702689|182855146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||t-test, 2 sided|||||||.47
91491306|NCT00702689|182855147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||t-test, 2 sided|||||||.29
91491307|NCT02805972|182855157|SUPERIORITY|"The null hypothesis is that there would be no difference across the Naloxone and placebo conditions.~The alternative hypothesis is that the cortisol value would be higher in the Naloxone condition than in the placebo condition."|Mean Difference (Final Values)|1.26||||0.067|TWO_SIDED|95.0|0.98|1.61||If the Winsorized value is excluded from analyses altogether, the P value is .012|t-test, 2 sided|Cortisol was log transformed for the statistical test, and the reported mean difference was exponentiated back to the original units of nmol/L below.||We compared cortisol values at 55 minutes, within person, across conditions. We Winsorized one participant's values for the placebo visit where values were between 2-4x above the 99th percentile value in the data and then log-transformed the data.||1.61|0.98|.067
91491308|NCT00939640|182855164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||Wilcoxon matched-pairs|||||||.17
91491309|NCT00939640|182855165|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon matched-pairs tests|||||||.02
91697395|NCT02111577|183288956|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.992|TWO_SIDED|95.0|0.875|1.145|||Log Rank|||Unstratified||1.145|0.875|0.992
91697396|NCT02111577|183288957|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.001||||0.994|TWO_SIDED|95.0|0.847|1.184|||Log Rank|||Stratified||1.184|0.847|0.994
91491310|NCT00939640|182855170|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
91491311|NCT00939640|182855171|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
91491312|NCT00389597|182855177|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.||||||0.0021|||||||Farrington Manning|||1 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.||||0.0021
91491313|NCT00389597|182855177|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.|||||<|0.0001|||||||Farrington-Manning|||"2 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc \<= 0 (not superior) Alternative hypothesis: Ha: pm-pc \>0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group."||||<0.0001
91491314|NCT00306189|182855182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|5.76|8.24|||t-test, 2 sided|||||8.24|5.76|<0.0001
91697397|NCT02111577|183288957|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.982|TWO_SIDED|95.0|0.851|1.18|||Log Rank|||Unstratified||1.18|0.851|0.982
91697398|NCT02111577|183288958|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.077||||0.392|TWO_SIDED|95.0|0.909|1.277|||Log Rank|||Stratified||1.277|0.909|0.392
91697399|NCT02111577|183288958|SUPERIORITY||Hazard Ratio (HR)|1.068||||0.439|TWO_SIDED|95.0|0.905|1.262|||Log Rank|||Unstratified||1.262|0.905|0.439
91758950|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838||||0.3266|TWO_SIDED|95.0|0.375|1.876||1-sided unstratified log-rank test|Log Rank|||No detected FLT3 expression||1.876|0.375|0.3266
91491315|NCT00306189|182855182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.0001||95.0|4.1|6.4|||t-test, 2 sided|||||6.4|4.1|<0.0001
91491316|NCT00306189|182855182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.27|||<|0.0001||95.0|5.06|7.49|||t-test, 2 sided|||||7.49|5.06|<0.0001
91491317|NCT00282984|182855192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001||95.0|4.13|8.86||To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected \& clinically meaningful var \& pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates \& corresponding 95% OR confidence interval (CI) from A30510285 \& A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.||8.86|4.13|<0.0001
91513237|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.82|||||TWO_SIDED|95.0|4.39|5.3||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.30|4.39|
91528381|NCT02564055|182932073|OTHER||Difference in percentages|43.4|||||TWO_SIDED|95.0|2.7|74.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 4 has been presented.|||74.6|2.7|
91758951|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate FLT3 expression||1.598|0.502|0.3597
91758952|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.342||||0.6907|TWO_SIDED|95.0|0.419|4.297||1-sided unstratified log-rank test|Log Rank|||Detected KIT expression||4.297|0.419|0.6907
91758953|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.199|TWO_SIDED|95.0|0.265|1.731||1-sided unstratified log-rank test|Log Rank|||Participants with no detected KIT expression||1.731|0.265|0.1990
91758954|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate KIT expression||1.598|0.502|0.3597
91758955|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.693||||0.3757|TWO_SIDED|95.0|0.071|6.765||1-sided unstratified log-rank test|Log Rank|||Detected RET expression||6.765|0.071|0.3757
91758956|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3723|TWO_SIDED|95.0|0.358|2.13||1-sided unstratified log-rank test|Log Rank|||No detected RET expression||2.130|0.358|0.3723
91758957|NCT00265317|183410829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3263|TWO_SIDED|95.0|0.501|1.523||1-sided unstratified log-rank test|Log Rank|||Indeterminate RET expression||1.523|0.501|0.3263
91758958|NCT00265317|183410830|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
91758959|NCT00265317|183410830|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
91758960|NCT00265317|183410832|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 2, Day 1||||<0.0001
91758961|NCT00265317|183410832|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 3, Day 1||||<0.0001
91758962|NCT00265317|183410837|SUPERIORITY_OR_OTHER|||||||0.3681||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3681
91758963|NCT00265317|183410838|SUPERIORITY_OR_OTHER|||||||0.5982||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.5982
91758964|NCT00265317|183410839|SUPERIORITY_OR_OTHER|||||||0.9807||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.9807
91758965|NCT00265317|183410840|SUPERIORITY_OR_OTHER|||||||0.3945||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3945
91758966|NCT02510001|183410880|OTHER||||||||||||||||||"The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with PD-0325901 at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or PD-0325901.~The MTD for the PD 0325901/PF-02341066 combination was 8mg BD(days1-21) and 200mg BD continuously in a 28 day cycle (Dose Level 4)."|||
91758967|NCT02510001|183410882|OTHER|||||||||||||||||The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with Binimetinib at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or Binimetinib.|"Binimetinib 30mg BD on days 1 - 21 every 28 days with Crizotinib 250 mg OD continuously is the MTD, the recommended dose and schedule for further evaluation in our and other trials.~This was as only one DLT was experienced in 6 evaluable patients at this final dose escalation level."|||
91758968|NCT04120402|183410906|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
91758969|NCT04120402|183410907|SUPERIORITY|||||||0.014|||||||ANCOVA|||||||0.014
91758970|NCT04120402|183410908|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91758971|NCT04120402|183410909|SUPERIORITY|||||||0.518|||||||ANCOVA|||||||0.518
91758972|NCT04120402|183410910|SUPERIORITY|||||||0.028|||||||Fisher Exact|||||||0.028
91758973|NCT00921843|183410919|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91758974|NCT00711971|183410920|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Significance for the BDI test at 26-28 weeks||||.29
91758975|NCT00711971|183410920|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Significance for BDI at 34-36 weeks gestation||||.51
91758976|NCT00711971|183410920|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||BDI score at 6-8 weeks postpartum||||.56
91491318|NCT00282984|182855193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||<|0.0001||95.0|1.97|5.18||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of treatment group \& center as independent var.||Estimates for expected and clinically meaningful var \& pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04) \& a power of 84% for the 2 key secondary endpts.||5.18|1.97|<0.0001
91491319|NCT00282984|182855194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.0001||95.0|1.82|4.38||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected and clinically meaningful varenicline (var) \& pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.||4.38|1.82|<0.0001
91491320|NCT00282984|182855195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.97|||<|0.0001||95.0|4.17|8.56|||Regression, Logistic|||Week 12 analysis||8.56|4.17|<0.0001
91491321|NCT00282984|182855196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001||95.0|2.03|4.23|||Regression, Logistic|||24 Week analysis||4.23|2.03|<0.0001
91491322|NCT00282984|182855197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0003||95.0|1.34|2.77|||Regression, Logistic|||52 Week analysis||2.77|1.34|0.0003
91697400|NCT02111577|183288959|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.238|||Log Rank|||Stratified||1.238|0.857|0.754
91697401|NCT02111577|183288959|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.924|TWO_SIDED|95.0|0.844|1.207|||Log Rank|||Unstratified||1.207|0.844|0.924
91491323|NCT00282984|182855198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0001||95.0|1.41|2.97|||Regression, Logistic|||||2.97|1.41|0.0001
91491324|NCT00282984|182855199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.51|5.93|||Regression, Logistic|||||5.93|2.51|<0.0001
91491325|NCT00282984|182855201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001||95.0|2.58|5.75|||Regression, Logistic|||||5.75|2.58|<0.0001
91491326|NCT04665856|182855249|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0348|TWO_SIDED|95.0|0.43|0.97||This study is a bridging study without formal testing, the p value here is descriptive.|Log Rank|||||0.97|0.43|0.0348
91491327|NCT04665856|182855250|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6105|TWO_SIDED|95.0|0.56|1.4||This study is a bridging study without formal testing, the p value here is descriptive.|Log Rank|||||1.40|0.56|0.6105
91491328|NCT04665856|182855251|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1044|TWO_SIDED|95.0|0.49|1.07|||Log Rank|||||1.07|0.49|0.1044
91491329|NCT04665856|182855252|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9363|TWO_SIDED|95.0|0.64|1.52|||Log Rank|||||1.52|0.64|0.9363
91491330|NCT04665856|182855253|SUPERIORITY||Difference in Overall Response Rates|22.55||||0.0136|TWO_SIDED|95.0|4.12|39.03|||Chi-square with Schouten Correction|||||39.03|4.12|0.0136
91491331|NCT04665856|182855254|SUPERIORITY||Difference in Overall Response Rates|17.37||||0.0493|TWO_SIDED|95.0|-0.22|33.6|||Chi-square with Schouten Correction|||||33.60|-0.22|0.0493
91491332|NCT04665856|182855257|SUPERIORITY||Difference in EFR at Month 6|8.09||||0.3968|TWO_SIDED|95.0|-10.62|26.81|||Z-test|||6 Months||26.81|-10.62|0.3968
91491333|NCT04665856|182855257|SUPERIORITY||Difference in EFR at Month 12|17.45||||0.0205|TWO_SIDED|95.0|2.69|32.21|||Z-test|||12 Months||32.21|2.69|0.0205
91491334|NCT04665856|182855258|SUPERIORITY||Difference in EFR at Month 6|8.18||||0.3633|TWO_SIDED|95.0|-9.46|25.82|||Z-test|||6 Months||25.82|-9.46|0.3633
91491335|NCT04665856|182855258|SUPERIORITY||Difference in EFR at Month12|13.36||||0.0642|TWO_SIDED|95.0|-0.79|27.51|||Z-test|||12 Months||27.51|-0.79|0.0642
91491336|NCT04665856|182855259|SUPERIORITY||Difference in EFR|20.47||||0.0261|TWO_SIDED|95.0|2.43|38.5|||Z-test|||12 Months||38.50|2.43|0.0261
91491337|NCT04665856|182855259|SUPERIORITY||Difference in EFR|-0.5||||0.9572|TWO_SIDED|95.0|-18.79|17.79|||Z-test|||24 Months||17.79|-18.79|0.9572
91491338|NCT04665856|182855260|SUPERIORITY||Difference in EFR|13.88||||0.1145|TWO_SIDED|95.0|-3.36|31.12|||Z-test|||12 Months||31.12|-3.36|0.1145
91491339|NCT04665856|182855260|SUPERIORITY||Difference in EFR|-2.54||||0.7734|TWO_SIDED|95.0|-19.83|14.75|||Z-test|||24 Months||14.75|-19.83|0.7734
91491340|NCT03386448|182855269|SUPERIORITY|Student test was performed|Mean Difference (Final Values)|9.0||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91697402|NCT02111577|183288960|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.918||||0.732|TWO_SIDED|95.0|0.563|1.497|||Log Rank|||Stratified||1.497|0.563|0.732
91697403|NCT02111577|183288960|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.713|TWO_SIDED|95.0|0.561|1.485|||Log Rank|||Unstratified||1.485|0.561|0.713
91758977|NCT00711971|183410921|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Gestational diabetes mellitus||||.06
91758978|NCT00711971|183410921|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||Hypertension or preeclampsia||||.12
91758979|NCT00711971|183410921|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Induced labor||||.20
91758980|NCT00711971|183410921|SUPERIORITY_OR_OTHER|||||||0.08|||||||Fisher Exact|||Cesarean section||||.08
91758981|NCT00711971|183410921|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||Spontaneous vaginal delivery||||.88
91758982|NCT00711971|183410921|SUPERIORITY_OR_OTHER|||||||0.32|||||||Fisher Exact|||Operative vaginal delivery||||.32
91758983|NCT00711971|183410922|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
91758984|NCT00711971|183410923|SUPERIORITY_OR_OTHER|||||||0.81|||||||ANOVA|||||||.81
91491341|NCT00114530|182855275|SUPERIORITY|||||||0.013||||||A Data and Safety Monitoring Board reviewed 4 pre-specified futility analyses that included an ability to stop for efficacy with p\<0.0001, leaving alpha equal to 0.0496 for the primary ITT analysis of the GRCS at 54 months post-randomization.|Wilcoxon (Mann-Whitney)|||||||0.013
91491342|NCT00114530|182855276|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91491343|NCT00114530|182855277|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91491344|NCT00114530|182855278|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91491345|NCT00114530|182855279|SUPERIORITY|||||||0.059|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.059
91491346|NCT00114530|182855279|SUPERIORITY|||||||0.06|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.06
91491347|NCT00114530|182855280|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.021
91491348|NCT00114530|182855280|SUPERIORITY|||||||0.03|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.03
91528382|NCT02564055|182932073|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
91697404|NCT02111577|183288961|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.891||||0.694|TWO_SIDED|95.0|0.5|1.587|||Log Rank|||Stratified||1.587|0.5|0.694
91697405|NCT02111577|183288961|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.661|TWO_SIDED|95.0|0.496|1.562|||Log Rank|||Unstratified||1.562|0.496|0.661
91491349|NCT00114530|182855281|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
91491350|NCT00114530|182855282|SUPERIORITY|||||||0.021|||||||Fisher Exact|||||||0.021
91491351|NCT00114530|182855283|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
91491352|NCT00114530|182855284|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91491353|NCT00114530|182855285|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
91491354|NCT00114530|182855286|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91491355|NCT00114530|182855287|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.28
91491356|NCT00114530|182855287|SUPERIORITY|||||||0.05|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.05
91491357|NCT00114530|182855288|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.19
91491358|NCT00114530|182855288|SUPERIORITY|||||||0.02|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.02
91491359|NCT00114530|182855289|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
91491360|NCT00114530|182855290|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
91491361|NCT00114530|182855291|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
91491362|NCT00114530|182855291|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
91491363|NCT00114530|182855292|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
91491364|NCT00114530|182855292|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.002
91491365|NCT00114530|182855293|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.001
91491366|NCT00114530|182855293|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.02
91491367|NCT00114530|182855293|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.05
91491368|NCT00114530|182855293|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.1
91491369|NCT00114530|182855294|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
91491370|NCT00114530|182855294|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.003
91491371|NCT00114530|182855294|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
91528383|NCT02564055|182932073|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 4 has been presented.|||51.2|-35.6|
91528384|NCT02564055|182932073|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-25.1|57.1|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 8 has been presented.|||57.1|-25.1|
91697406|NCT02111577|183288962|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.895||||0.111|TWO_SIDED|95.0|0.781|1.027|||Log Rank|||Stratified||1.027|0.781|0.111
91697407|NCT02111577|183288962|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.184|TWO_SIDED|95.0|0.798|1.044|||Log Rank|||Unstratified||1.044|0.798|0.184
91491372|NCT00114530|182855294|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.07
91491373|NCT00114530|182855295|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.08
91491374|NCT00114530|182855295|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.9
91491375|NCT00114530|182855296|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.1
91491376|NCT00114530|182855296|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.6
91491377|NCT00114530|182855297|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
91697408|NCT02111577|183288963|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.939||||0.46|TWO_SIDED|95.0|0.795|1.11|||Log Rank|||Stratified||1.11|0.795|0.46
91491378|NCT00114530|182855297|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.3
91697409|NCT02111577|183288963|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.534|TWO_SIDED|95.0|0.807|1.118|||Log Rank|||Unstratified||1.118|0.807|0.534
91697410|NCT02111577|183288964|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.845||||0.485|TWO_SIDED|95.0|0.528|1.355|||Log binomial model|||Stratified||1.355|0.528|0.485
91697411|NCT02111577|183288965|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.92||||0.768|TWO_SIDED|95.0|0.529|1.601|||Log binomial model|||Stratified||1.601|0.529|0.768
91729144|NCT01197300|183353729|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.41||||0.9236|TWO_SIDED|95.0|-2.423|1.603||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 24||1.603|-2.423|0.9236
91729145|NCT01197300|183353730|OTHER|The number and percentage of patients with new vertebral fractures during the 12 month Extension period was presented by Core treatment group. Between-treatment differences were evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New vertebral fractures at Month 12 Extension||||1.0000
91729146|NCT01197300|183353731|OTHER|The number and percentage of patients with new morphometric vertebral fractures during the 12 month extension period was presented by core treatment group. Between-treatment differences will be evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New morphometric vertebral fractures at Month 12 Extension||||1.0000
91729147|NCT01197300|183353732|OTHER||Odds Ratio (OR)|4.73||||0.3971|TWO_SIDED|95.0|0.13|173.07||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 15||173.07|0.13|0.3971
91729148|NCT01197300|183353732|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 18||999.99|0.01|0.6046
91729149|NCT01197300|183353732|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 21||999.99|0.01|0.6046
91491379|NCT00114530|182855298|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.03
91491380|NCT00114530|182855298|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.5
91491381|NCT00114530|182855299|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.002
91491382|NCT00114530|182855299|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.05
91697412|NCT04501640|183288973|OTHER||Geomteric Least Squares (LS) Mean Ratio|57.06|||||TWO_SIDED|90.0|46.21|70.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an analysis of variance (ANOVA) performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.47|46.21|
91697413|NCT04501640|183288973|OTHER||Geometric LSMean Ratio|61.42|||||TWO_SIDED|90.0|52.06|72.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.47|52.06|
91729150|NCT01197300|183353732|OTHER||Odds Ratio (OR)|1.31||||0.875|TWO_SIDED|95.0|0.05|38.04||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 24||38.04|0.05|0.8750
91758985|NCT00711971|183410924|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.||||||<.001
91758986|NCT00711971|183410925|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||||||.39
91758987|NCT00711971|183410926|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|||||||.19
91729151|NCT01197300|183353733|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.01||||0.9231|TWO_SIDED|95.0|-0.18|0.17||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL1 at Month 24||0.17|-0.18|0.9231
91729152|NCT01197300|183353733|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.11||||0.2694|TWO_SIDED|95.0|-0.32|0.1||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Extension baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL2 at Month 24||0.10|-0.32|0.2694
91729153|NCT02255279|183353753|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|3.0|5.51|||ANCOVA|||Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.||5.51|3.00|
91729154|NCT02255279|183353753|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|2.05|3.25|||ANCOVA|||Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||3.25|2.05|
91729155|NCT02255279|183353753|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.67|||||TWO_SIDED|95.0|3.52|6.2|||ANCOVA|||Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||6.20|3.52|
91729156|NCT02255279|183353754|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|17.0|||||TWO_SIDED|95.0|8.1|26.3|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.||26.3|8.1|
91729157|NCT02255279|183353754|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|-1.8|21.0|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.||21|-1.8|
91729158|NCT02255279|183353754|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|58.0|||||TWO_SIDED|95.0|47.5|68.5|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.||68.5|47.5|
91729159|NCT01052428|183353783|SUPERIORITY_OR_OTHER|||||||0.4568||95.0|||||Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.4568
91729160|NCT01052428|183353784|SUPERIORITY_OR_OTHER|||||||0.1967||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.1967
91491383|NCT00114530|182855300|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
91491384|NCT00114530|182855300|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
91729161|NCT01052428|183353785|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.55
91729162|NCT01052428|183353786|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.21
91729163|NCT01052428|183353787|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.006
91729164|NCT01052428|183353788|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.16
91729165|NCT01052428|183353789|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.001
91729166|NCT00871000|183353792|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.||2.7|-2.61|
91729167|NCT00871000|183353792|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.||2.7|-2.61|
91729168|NCT00871000|183353792|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.72||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.||2.72|-2.61|
91729169|NCT00871000|183353793|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.||2.7|-2.61|
91729170|NCT00871000|183353793|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.||2.7|-2.61|
91729171|NCT03400787|183353809|SUPERIORITY|||||||0.0001||||||p\<0.025 indicates statistical significance.|t-test, 1 sided|||Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.||||0.0001
91729172|NCT02837952|183353822|SUPERIORITY||Least Square Mean Difference|72.89|||<|0.001|TWO_SIDED|95.0|50.075|95.707|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||95.707|50.075|<0.001
91758988|NCT00711971|183410927|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91491385|NCT00114530|182855301|SUPERIORITY|||||||0.42|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.42
91491386|NCT00114530|182855301|SUPERIORITY|||||||0.048|||||||Chi-squared|||CHF requiring clinical treatment||||0.048
91491387|NCT00114530|182855301|SUPERIORITY|||||||0.51|||||||Chi-squared|||Clinically significant pericardial effusion||||0.51
91491388|NCT00114530|182855302|SUPERIORITY|||||||0.46|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.46
91491389|NCT00114530|182855302|SUPERIORITY|||||||0.042|||||||Chi-squared|||CHF requiring clinical treatment||||0.042
91697414|NCT04501640|183288974|OTHER||Geomteric LSMean Ratio|53.31|||||TWO_SIDED|90.0|43.02|66.05|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||66.05|43.02|
91697415|NCT04501640|183288974|OTHER||Geomteric LSMean Ratio|59.14|||||TWO_SIDED|90.0|49.48|70.7|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.70|49.48|
91758989|NCT00711971|183410928|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||||||0.54
91491390|NCT00114530|182855302|SUPERIORITY|||||||0.15|||||||Chi-squared|||Clinically significant pericardial effusion||||0.15
91491391|NCT00114530|182855303|SUPERIORITY|||||||0.026|||||||Chi-squared|||||||0.026
91491392|NCT00114530|182855304|SUPERIORITY|||||||0.022|||||||Chi-squared|||||||0.022
91491393|NCT00114530|182855305|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
91491394|NCT00114530|182855306|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
91491395|NCT00114530|182855307|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
91758990|NCT00887549|183410938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015|||<|0.0001|TWO_SIDED|95.0|1.008|1.021|||Regression, Cox|The Cox model, based upon participant level data, included PFS as dependent variable and TS score in the nucleus as independent variable.||||1.021|1.008|<0.0001
91758991|NCT01919801|183410982|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||||||Test was performed using a weighted log-rank test called the Peto-Prentice test with a global 2-sided significance level of 5% after adjusting for stratification factors (race, and severity) in the ITT population.|Adjusted Peto-Prentice|||A total of 121 participants were analysed, however 3 participants did not receive the study medication and were censored at time 0.||||0.633
91758992|NCT01059994|183410992|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
91758993|NCT01059994|183410993|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
91758994|NCT01677858|183410994|OTHER||Maximum Tolerated Dose (mg/m²)|70.0|||||TWO_SIDED|||||||||||||
91758995|NCT00988091|183411010|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.33||||0.034|TWO_SIDED|95.0|0.41|10.24||The p-value was not adjusted for multiple comparisons because there was a single treatment comparison for the primary endpoint. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||A treatment difference of \>=7.0 mm and a pooled SD of 27.6 mm, requires a sample size of 244 subjects/treatment to complete the trial at 80% power at a two-sided significance level of 5%. To account for 18% dropout rate, the sample size was increased to 298/arm (total of 596). The primary null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||10.24|0.41|0.034
91758996|NCT00988091|183411011|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.89||||0.175|TWO_SIDED|95.0|-1.29|7.08||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||7.08|-1.29|0.175
91758997|NCT00988091|183411012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.777||||0.193|TWO_SIDED|95.0|0.532|1.136||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||1.136|0.532|0.193
91758998|NCT00988091|183411013|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Cochran-Mantel-Haenszel|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||||0.887
91758999|NCT00988091|183411015|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.0||||0.116|TWO_SIDED|95.0|-0.99|8.98||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||8.98|-0.99|0.116
91759000|NCT00988091|183411016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.081|TWO_SIDED|95.0|0.483|1.044||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.\[||1.044|0.483|0.081
91759001|NCT03078855|183411022|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.26|TWO_SIDED|95.0|0.83|1.98|||Regression, Cox||The EFS hazard ratio was adjusted for enrolling site, continuous age at randomization, and (via stratification) 3 randomization strata: non-follicular histology, follicular (FL) with low/intermediate FLIPI score and FL with high FLIPI score.|||1.98|0.83|0.26
91491396|NCT00114530|182855308|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
91729173|NCT02837952|183353823|SUPERIORITY||Least Square Mean Difference|26.45|||<|0.001|TWO_SIDED|95.0|19.895|33.005|||ANCOVA|||0 to 8 hours: Treatment difference and 95% CI were based on least square (LS) mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||33.005|19.895|< 0.001
91491397|NCT00114530|182855309|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
91697416|NCT04501640|183288975|OTHER||Geometric LSMean Ratio|38.93|||||TWO_SIDED|90.0|26.78|56.59|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||56.59|26.78|
91697417|NCT04501640|183288975|OTHER||Geometric LSMean Ratio|47.9|||||TWO_SIDED|90.0|31.76|72.24|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.24|31.76|
91697418|NCT04590586|183288987|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6672|TWO_SIDED|95.0|0.59|2.35|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (Lanadelumab vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||2.35|0.59|0.6672
91697419|NCT04590586|183288988|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8779|TWO_SIDED|95.0|0.77|1.24|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (apremilast vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.24|0.77|0.8779
91697420|NCT04590586|183289000|OTHER||Risk Difference (RD)|-4.0||||0.3773|TWO_SIDED|95.0|-12.9|4.9|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||4.9|-12.9|0.3773
91697421|NCT04590586|183289000|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.52|1.28|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.28|0.52|
91697422|NCT04590586|183289001|OTHER||Risk Difference (RD)|-2.9||||0.4846|TWO_SIDED|95.0|-11.2|5.3|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||5.3|-11.2|0.4846
91697423|NCT04590586|183289001|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.51|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.37|0.51|
91697424|NCT04590586|183289002|OTHER||Risk Difference (RD)|0.2||||0.9665|TWO_SIDED|95.0|-7.3|7.6|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||7.6|-7.3|0.9665
91491398|NCT00114530|182855310|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91697425|NCT04590586|183289002|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.59|1.74|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.74|0.59|
91697426|NCT04590586|183289003|OTHER||Odds Ratio (OR)|1.02||||0.9119|TWO_SIDED|95.0|0.71|1.46|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 8||1.46|0.71|0.9119
91491399|NCT00114530|182855311|SUPERIORITY||||||<|0.001|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||<0.001
91491400|NCT00114530|182855311|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.61, Probably related = 0.57, Definitely related = 0.52|||||
91491401|NCT00114530|182855311|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.17, Probably related = 0.09, Definitely related = 0.04|||||
91697427|NCT04590586|183289003|OTHER||Odds Ratio (OR)|1.09||||0.6475|TWO_SIDED|95.0|0.75|1.58|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 15||1.58|0.75|0.6475
91697428|NCT04590586|183289003|OTHER||Odds Ratio (OR)|0.98||||0.9071|TWO_SIDED|95.0|0.64|1.48|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 29||1.48|0.64|0.9071
91697429|NCT04590586|183289004|OTHER||Odds Ratio (OR)|1.15||||0.4507|TWO_SIDED|95.0|0.8|1.66|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.66|0.80|0.4507
91491402|NCT00114530|182855313|SUPERIORITY|||||||0.7|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||0.7
91491403|NCT00114530|182855313|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.76|||||
91491404|NCT00114530|182855313|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.80|||||
91491405|NCT01466153|182855326|SUPERIORITY_OR_OTHER|||||||0.4475|||||||Cochran-Mantel-Haenszel|||||||0.4475
91491406|NCT01466153|182855330|SUPERIORITY_OR_OTHER|||||||0.3206|||||||Cochran-Mantel-Haenszel|||||||0.3206
91491407|NCT01466153|182855331|SUPERIORITY_OR_OTHER|||||||0.313|||||||Cochran-Mantel-Haenszel|||||||0.3130
91697430|NCT04590586|183289005|OTHER||Odds Ratio (OR)|0.99||||0.9741|TWO_SIDED|95.0|0.64|1.53|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.53|0.64|0.9741
91491408|NCT01466153|182855333|SUPERIORITY_OR_OTHER|||||||0.9527|||||||Log Rank|||||||0.9527
91697431|NCT04590586|183289006|OTHER||Odds Ratio (OR)|1.04||||0.8754|TWO_SIDED|95.0|0.64|1.7|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.70|0.64|0.8754
91697432|NCT04590586|183289007|OTHER||Risk Difference (RD)|0.2||||0.9695|TWO_SIDED|95.0|-8.7|9.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||9.1|-8.7|0.9695
91697433|NCT04590586|183289007|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||1.59|0.64|
91729174|NCT02837952|183353823|SUPERIORITY||LS Mean Difference|7.91|||<|0.001|TWO_SIDED|95.0|5.196|10.632|||ANCOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.632|5.196|< 0.001
91491409|NCT01703039|182855349|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
91491410|NCT01703039|182855350|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
91491411|NCT01703039|182855351|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
91491412|NCT01703039|182855352|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
91697434|NCT04590586|183289007|OTHER||Risk Difference (RD)|-2.4||||0.6236|TWO_SIDED|95.0|-11.9|7.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||7.1|-11.9|0.6236
91697435|NCT04590586|183289007|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.59|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||1.37|0.59|
91491413|NCT01703039|182855353|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91491414|NCT02342327|182855360|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.55|1.22||||||Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.22|0.55|
91491415|NCT02342327|182855361|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.42|1.06||||||Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.06|0.42|
91491416|NCT01637935|182855386|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||||95.0|0.92|1.31||||||Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.||1.31|0.92|
91491417|NCT01637935|182855386|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||||95.0|0.89|1.26||||||Fully adjusted adding the proteinuria testing variable.||1.26|0.89|
91491418|NCT01637935|182855387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||||95.0|0.71|1.12||||||Time since starting pioglitazone \<4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.12|0.71|
91528385|NCT02564055|182932073|OTHER||Difference in percentages|47.7|||||TWO_SIDED|95.0|4.8|78.7|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 8 has been presented.|||78.7|4.8|
91528386|NCT02564055|182932073|OTHER||Difference in percentages|-11.7|||||TWO_SIDED|95.0|-51.3|30.2|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 8 has been presented.|||30.2|-51.3|
91697436|NCT04590586|183289007|OTHER||Risk Difference (RD)|-6.2||||0.1664|TWO_SIDED|95.0|-14.9|2.5|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||2.5|-14.9|0.1664
91729175|NCT02837952|183353823|SUPERIORITY||LS Mean Difference|51.67|||<|0.001|TWO_SIDED|95.0|37.075|66.258|||ANCOVA|||0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||66.258|37.075|< 0.001
91729176|NCT02837952|183353823|SUPERIORITY||LS Mean Difference|27.32|||<|0.001|TWO_SIDED|95.0|18.139|36.508|||ANCOVA|||8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||36.508|18.139|< 0.001
91491419|NCT01637935|182855387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||||95.0|0.93|1.59||||||Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.59|0.93|
91491420|NCT01637935|182855387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||||95.0|0.83|1.75||||||Time since starting pioglitazone \>8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.75|0.83|
91491421|NCT01637935|182855388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||||95.0|0.68|1.16||||||Duration of therapy \<1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.68|
91491422|NCT01637935|182855388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.8|1.33||||||Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.33|0.80|
91491423|NCT01637935|182855388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||||95.0|0.87|1.54||||||Duration of therapy \>4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.54|0.87|
91491424|NCT01637935|182855389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.69|1.16||||||Cumulative dose 1-14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.69|
91491425|NCT01637935|182855389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.85|1.42||||||Cumulative dose 14001-40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.42|0.85|
91491426|NCT01637935|182855389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||||95.0|0.79|1.44||||||Cumulative dose \>40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.44|0.79|
91491427|NCT02200211|182855392|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.||0.53||
91697437|NCT04590586|183289007|OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.45|1.15|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||1.15|0.45|
91697438|NCT04590586|183289008|OTHER||Risk Difference (RD)|-0.5||||0.9043|TWO_SIDED|95.0|-9.3|8.3|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||8.3|-9.3|0.9043
91697439|NCT04590586|183289008|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.62|1.54|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.54|0.62|
91697440|NCT01893281|183289024|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91697441|NCT00910208|183289027|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
91697442|NCT00910208|183289028|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
91697443|NCT00910208|183289029|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
91697444|NCT00910208|183289030|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
91697445|NCT00910208|183289031|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91697446|NCT00910208|183289032|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91697447|NCT00737204|183289033|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
91729177|NCT02837952|183353823|SUPERIORITY||LS Mean Difference|138.65|||<|0.001|TWO_SIDED|95.0|91.045|186.261|||ANCOVA|||0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||186.261|91.045|< 0.001
91729178|NCT02837952|183353824|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
91729179|NCT02837952|183353825|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
91729180|NCT01959919|183353826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.907||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between ease of using clotting factor treatment score at Final visit (Month 8) and baseline visit||||0.000
91729181|NCT01959919|183353827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.572|STANDARD_ERROR_OF_MEAN|0.584||0|TWO_SIDED|95.0|3.411|5.733|||t-test, 2 sided|||Comparison between time for reconstructing the drug at Final visit (Month 8) and baseline visit||5.733|3.411|0.000
91729182|NCT01959919|183353828|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.789||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between burden of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
91729183|NCT01959919|183353829|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.98||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between impact of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
91729184|NCT01959919|183353830|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.445||||0.001|||||||Wilcoxon Signed Ranks Test|||Comparison between risk associated with clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.001
91729185|NCT02003898|183353855|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|-0.03|0.098||||||||0.098|-0.03|
91729186|NCT03721107|183353990|SUPERIORITY||Difference in Percentage|7.9||||0.152|TWO_SIDED|95.0|-6.0|21.9||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||21.9|-6.0|0.152
91729187|NCT03721107|183353990|SUPERIORITY||Difference in Percentage|5.6||||0.216|TWO_SIDED|95.0|-6.8|18.0||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||18.0|-6.8|0.216
91729188|NCT02991859|183354008|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FF E0 (Response of Placebo participants)|||19.39|9.39|
91729189|NCT02991859|183354008|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||Emax-Maximum Dose response|||25.40|8.21|
91729190|NCT02991859|183354008|OTHER||3 parameter Emax model|48.52|||||TWO_SIDED|95.0|18.21|129.32|||||ED50-Dose at which 50% of the maximum dose response reached (mcg)|||129.32|18.21|
91729191|NCT02991859|183354008|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FP E0-Response of Placebo participants|||19.39|9.39|
91697448|NCT00737204|183289034|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||ANCOVA|||Repeated measure analysis||||.01
91697449|NCT00737204|183289035|SUPERIORITY_OR_OTHER||||||>=|0.805||95.0|||||Paired t-tests|||Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.||||>=.805
91697450|NCT03605862|183289042|SUPERIORITY|||||||0.4009|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.4009
91697451|NCT03605862|183289043|SUPERIORITY|||||||0.1923|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.1923
91697452|NCT03605862|183289044|SUPERIORITY|||||||0.2057|||||||Fisher Exact|||||||0.2057
91697453|NCT03605862|183289045|SUPERIORITY|||||||0.0712|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at Baseline, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0712
91697454|NCT03605862|183289046|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for study day 2||||1.0000
91697455|NCT03605862|183289046|SUPERIORITY|||||||0.9142|||||||Fisher Exact|||Comparison for study day 3||||0.9142
91697456|NCT03605862|183289046|SUPERIORITY|||||||0.0132|||||||Fisher Exact|||Comparison for study day 7||||0.0132
91697457|NCT03605862|183289047|SUPERIORITY|||||||0.1239|||||||t-test, 2 sided|||Comparison for day 2||||0.1239
91697458|NCT03605862|183289047|SUPERIORITY|||||||0.1022|||||||t-test, 2 sided|||Comparison for day 3||||0.1022
91697459|NCT03605862|183289047|SUPERIORITY|||||||0.46213|||||||t-test, 2 sided|||Comparison for day 7||||0.46213
91697460|NCT03605862|183289050|SUPERIORITY|||||||0.014|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0140
91697461|NCT03605862|183289051|SUPERIORITY|||||||0.0112|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0112
91697462|NCT03605862|183289052|SUPERIORITY||||||<|0.0001|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||<0.0001
91697463|NCT00778869|183289053|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student t-test|||||||<0.05
91697464|NCT01582178|183289088|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Fisher Exact|||||||0.89
91697465|NCT00570063|183289089|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.61|STANDARD_ERROR_OF_MEAN|8.94||0.86|TWO_SIDED|90.0|-16.49|13.27|||Mixed Models Analysis|||P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||13.27|-16.49|0.86
91697466|NCT00570063|183289090|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|2.69||0.65|TWO_SIDED|90.0|-5.71|3.24|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.24|-5.71|0.65
91697467|NCT00570063|183289091|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|2.61||0.93|TWO_SIDED|90.0|-4.59|4.1|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.10|-4.59|0.93
91697468|NCT00570063|183289092|SUPERIORITY_OR_OTHER||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|4.18||0.86|TWO_SIDED|90.0|-6.21|7.69|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||7.69|-6.21|0.86
91697469|NCT00570063|183289093|SUPERIORITY_OR_OTHER||LS mean difference|-2.57|STANDARD_ERROR_OF_MEAN|3.22||0.43|TWO_SIDED|90.0|-7.92|2.79|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.79|-7.92|0.43
91697470|NCT00570063|183289094|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.68||0.91|TWO_SIDED|90.0|-4.76|4.16|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.16|-4.76|0.91
91697471|NCT00570063|183289095|SUPERIORITY_OR_OTHER||LS mean difference|0.63|STANDARD_ERROR_OF_MEAN|2.29||0.78|TWO_SIDED|90.0|-3.17|4.43|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.43|-3.17|0.78
91697472|NCT00570063|183289096|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.35||0.92|TWO_SIDED|90.0|-2.11|2.39|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.39|-2.11|0.92
91491428|NCT02200211|182855392|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).||0.53||
91697473|NCT00570063|183289097|SUPERIORITY_OR_OTHER||LS mean difference|0.84|STANDARD_ERROR_OF_MEAN|1.62||0.6|TWO_SIDED|90.0|-1.85|3.54|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.54|-1.85|0.60
91697474|NCT00570063|183289098|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.86||0.81|TWO_SIDED|90.0|-2.65|3.53|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.53|-2.65|0.81
91697475|NCT00570063|183289099|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.48||0.93|TWO_SIDED|90.0|-0.84|0.76|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||0.76|-0.84|0.93
91697476|NCT00570063|183289100|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.68||0.99|TWO_SIDED|90.0|-1.13|1.14|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.||1.14|-1.13|0.99
91697477|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.158|STANDARD_DEVIATION|0.844|||TWO_SIDED|90.0|-1.546|1.231||||||Change at Day 21: Cried||1.231|-1.546|
91697478|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.444|STANDARD_DEVIATION|1.078|||TWO_SIDED|90.0|-1.329|2.218||||||Change at Day 21: Felt blue or depressed||2.218|-1.329|
91697479|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.544|STANDARD_DEVIATION|4.32|||TWO_SIDED|90.0|-5.561|8.649||||||Change at Day 21: Irritability||8.649|-5.561|
91697480|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_DEVIATION|2.955|||TWO_SIDED|90.0|-4.287|5.433||||||Change at Day 21: Manifest psychosis||5.433|-4.287|
91697481|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_DEVIATION|2.096|||TWO_SIDED|90.0|-2.892|4.003||||||Change at Day 21: Personal neatness||4.003|-2.892|
91697482|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.327|STANDARD_DEVIATION|0.532|||TWO_SIDED|90.0|-1.202|0.547||||||Change at Day 21: Refused to speak||0.547|-1.202|
91697483|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.632|STANDARD_DEVIATION|2.749|||TWO_SIDED|90.0|-5.152|3.889||||||Change at Day 21: Retardation||3.889|-5.152|
91697484|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.572|||TWO_SIDED|90.0|-1.11|0.771||||||Change at Day 21: Said he/she was no good||0.771|-1.110|
91697485|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.561|STANDARD_DEVIATION|2.63|||TWO_SIDED|90.0|-4.887|3.764||||||Change at Day 21: Social competence||3.764|-4.887|
91729192|NCT02991859|183354008|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||FP Emax-Maximum Dose response|||25.40|8.21|
91697486|NCT00570063|183289101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62|STANDARD_DEVIATION|4.447|||TWO_SIDED|90.0|-7.934|6.694||||||Change at Day 21: Social interest||6.694|-7.934|
91697487|NCT00570063|183289102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.712|STANDARD_DEVIATION|12.24|||TWO_SIDED|90.0|-14.42|25.845||||||||25.845|-14.42|
91697488|NCT00570063|183289112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.849|STANDARD_DEVIATION|4.23|||TWO_SIDED|90.0|-7.807|6.109||||||||6.109|-7.807|
91697489|NCT00570063|183289113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.195|STANDARD_DEVIATION|9.307|||TWO_SIDED|90.0|-19.5|11.114||||||||11.114|-19.50|
91697490|NCT00570063|183289114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.273|STANDARD_DEVIATION|3.488|||TWO_SIDED|90.0|-6.01|5.465||||||Change at Day 21: Parkinsonism||5.465|-6.010|
91697491|NCT00570063|183289114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_DEVIATION|3.008|||TWO_SIDED|90.0|-5.13|4.766||||||Change at Day 21: Dyskinesia||4.766|-5.130|
91697492|NCT00570063|183289114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.932|STANDARD_DEVIATION|1.425|||TWO_SIDED|90.0|-3.275|1.411||||||Change at Day 21: Dystonia||1.411|-3.275|
91697493|NCT00570063|183289114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.705|STANDARD_DEVIATION|1.652|||TWO_SIDED|90.0|-2.013|3.422||||||Change at Day 21: Akathisia||3.422|-2.013|
91697494|NCT00570063|183289115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291|STANDARD_DEVIATION|1.203|||TWO_SIDED|90.0|-2.27|1.688||||||Change at Day 4||1.688|-2.270|
91697495|NCT00570063|183289115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.327|STANDARD_DEVIATION|1.349|||TWO_SIDED|90.0|-1.892|2.547||||||Change at Day 7||2.547|-1.892|
91697496|NCT00570063|183289115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.436|STANDARD_DEVIATION|1.448|||TWO_SIDED|90.0|-1.946|2.817||||||Change at Day 14||2.817|-1.946|
91697497|NCT00570063|183289115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.133|||TWO_SIDED|90.0|-1.763|1.963||||||Change at Day 21||1.963|-1.763|
91729193|NCT02991859|183354008|OTHER||3 parameter Emax model|1081.27|||||TWO_SIDED|95.0|448.0|2609.66|||||FP ED50-Dose at which 50% of the maximum dose response reached (mcg)|||2609.66|448.00|
91729194|NCT02991859|183354008|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||BUD E0-Response of Placebo participants|||19.39|9.39|
91729195|NCT02991859|183354008|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||BUD Emax-Maximum Dose response|||25.40|8.21|
91729196|NCT02991859|183354008|OTHER||3 parameter Emax model|1467.36|||||TWO_SIDED|95.0|546.51|3939.84|||||BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)|||3939.84|546.51|
91729197|NCT02991859|183354009|OTHER||Exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FF E0-Response of Placebo participants|||190.38|162.87|
91729198|NCT02991859|183354009|OTHER||exponential power-law model|899.99|||||TWO_SIDED|95.0|698.36|1101.62|||||FF ED50 Dose at which 50% of the maximum dose response reached|||1101.62|698.36|
91697498|NCT01031680|183289152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0473|<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.37|-0.56|<0.0001
91491429|NCT02200211|182855392|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.54|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).||0.54||
91697499|NCT01031680|183289153|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||<|0.0001|TWO_SIDED|95.0|7.0|12.9||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.9|7.0|<0.0001
91697500|NCT01031680|183289154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.7898||0.0126|TWO_SIDED|95.0|-3.52|-0.42||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.42|-3.52|0.0126
91697501|NCT01031680|183289155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001||95.0|-2.64|-1.89||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.89|-2.64|<0.0001
91697502|NCT01031680|183289156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.8203||0.0174|TWO_SIDED|95.0|-3.56|-0.34||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.34|-3.56|0.0174
91697503|NCT01031680|183289157|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|2.126|<|0.0001|TWO_SIDED|95.0|8.3|16.6||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender)||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||16.6|8.3|<0.0001
91729199|NCT02991859|183354009|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FP E0-Response of Placebo participants|||190.38|162.87|
91729200|NCT02991859|183354009|OTHER||exponential power-law model|1986.05|||||TWO_SIDED|95.0|1574.7|2397.39|||||FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2397.39|1574.70|
91729201|NCT02991859|183354009|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||BUD E0 - Response of Placebo participants|||190.38|162.87|
91729202|NCT02991859|183354009|OTHER||exponential power-law model|1927.42|||||TWO_SIDED|95.0|1698.47|2156.37|||||BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2156.37|1698.47|
91729203|NCT02991859|183354010|OTHER||Emax Model|289.73|||||TWO_SIDED|95.0|224.82|354.64|||||ED20 Cortisol Suppression 0-24 Hours Weighted Mean|||354.64|224.82|
91729204|NCT02991859|183354010|OTHER||Emax Model|194.09|||||TWO_SIDED|95.0|72.82|517.28|||||ED80 for AMP PC20|||517.28|72.82|
91729205|NCT02991859|183354011|OTHER||Emax Model|639.36|||||TWO_SIDED|95.0|506.94|771.79|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||771.79|506.94|
91729206|NCT02991859|183354011|OTHER||Emax Model|4325.07|||||TWO_SIDED|95.0|1792.02|10438.64|||||ED80 for AMP PC20|||10438.64|1792.02|
91729207|NCT02991859|183354012|OTHER||Emax Model|620.49|||||TWO_SIDED|95.0|546.79|694.2|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||694.20|546.79|
91729208|NCT02991859|183354012|OTHER||Emax Model|5869.45|||||TWO_SIDED|95.0|2186.03|15759.35|||||ED80 for AMP PC20|||15759.35|2186.03|
91729209|NCT00425854|183354073|SUPERIORITY_OR_OTHER||Maximum Likelihood|0.048|||||TWO_SIDED|95.0|0.001|0.238|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI.|||0.238|0.001|
91759002|NCT03194646|183411044|OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-2.44|-1.26||||||||-1.26|-2.44|
91759003|NCT03194646|183411044|OTHER||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-2.87|-1.8||||||||-1.80|-2.87|
91759004|NCT03194646|183411044|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-2.51|-1.1||||||||-1.10|-2.51|
91528387|NCT02564055|182932073|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 8 has been presented.|||51.2|-35.6|
91697504|NCT00789698|183289163|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.|Hazard Ratio (HR)|0.728|||||TWO_SIDED|95.0|0.41|1.295||There is no hypothesis tested. Since this was a non-inferiority study, the upper bound of the 95% CI for the hazard ratio was compared to the pre-specified margin of 1.93 to demonstrate the non-inferiority of lurasidone compared to Quetiapine XR.|COX Proportional Hazards Model|||Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.||1.295|0.410|
91697505|NCT01921101|183289167|SUPERIORITY_OR_OTHER|||||||0.29|||||||Chi-squared|||||||0.29
91697506|NCT00150488|183289173|OTHER|Compared to baseline|||||<|0.001|||||||Chi-squared|||||||<0.001
91697507|NCT05129293|183289194|SUPERIORITY|||||||0.229|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.229
91697508|NCT05129293|183289195|SUPERIORITY|||||||0.04|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.040
91697509|NCT05129293|183289196|SUPERIORITY|||||||0.266|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.266
91697510|NCT00519428|183289197|SUPERIORITY|Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|4.0||0.05|TWO_SIDED|||||"Each individual test will require the calculated p to be \< .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05."|Cochran-Mantel-Haenszel|||Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.||||.05
91697511|NCT00519428|183289199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|8.0||0.0916|TWO_SIDED|95.0||||escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns|ANCOVA|adjusting for baseline score and country||To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country||||.0916
91697512|NCT01729338|183289210|SUPERIORITY_OR_OTHER|||||||0.45||||||Compared baseline to 3 months|paired t-test|||||||0.45
91697513|NCT01729338|183289210|SUPERIORITY_OR_OTHER|||||||0.19|||||||paired t-test|compares baseline to month 5||||||0.19
91697514|NCT01729338|183289211|SUPERIORITY_OR_OTHER|||||||0.1||||||baseline, 3 month|paired t-test|||||||0.1
91697515|NCT01729338|183289211|SUPERIORITY_OR_OTHER|||||||0.09|||||||paired t-test|baseline, month 5||||||0.09
91528388|NCT02564055|182932073|OTHER||Difference in percentages|6.4|||||TWO_SIDED|95.0|-35.4|48.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||48.5|-35.4|
91697516|NCT00688701|183289214|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.123|<|0.0001|TWO_SIDED|95.0|-0.785|-0.3||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.300|-0.785|<0.0001
91697517|NCT00688701|183289214|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-0.903|-0.423||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.423|-0.903|<0.0001
91697518|NCT01953874|183289229|OTHER|The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang.||||||0.916|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects.||||0.916
91491430|NCT02200211|182855392|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.56|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to \<20 weeks after randomization).||0.56||
91697519|NCT00653133|183289284|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.||||<0.05
91697520|NCT01669174|183289366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|106.1|||<|0.001|TWO_SIDED|90.0|104.64|107.58|||ANCOVA|||Week 4||107.58|104.64|<0.001
91697521|NCT01669174|183289366|SUPERIORITY_OR_OTHER||Median Difference (Net)|107.75|||<|0.001|TWO_SIDED|90.0|106.18|109.35|||ANCOVA|||Week 8||109.35|106.18|<0.001
91697522|NCT01669174|183289366|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.63|||<|0.001|TWO_SIDED|90.0|106.31|111.0|||ANCOVA|||Week 16||111.00|106.31|<0.001
91697523|NCT01669174|183289366|SUPERIORITY_OR_OTHER||Median Difference (Net)|106.63|||<|0.001|TWO_SIDED|90.0|104.39|108.93|||ANCOVA|||Week 24||108.93|104.39|<0.001
91697524|NCT01953601|183289381|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.1||||0.6734|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.6734
91697525|NCT01953601|183289381|SUPERIORITY||Difference in Least Squares Means (LSM)|0.4||||0.0141|TWO_SIDED|97.51|0.0|0.8|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.8|0.0|0.0141
91697526|NCT01953601|183289383|OTHER||Difference in % vs Placebo|4.32|||||TWO_SIDED|95.0|0.4|8.31|||||Difference in % = Arm A - Arm C|||8.31|0.40|
91697527|NCT01953601|183289383|OTHER||Difference in % vs Placebo|5.17|||||TWO_SIDED|95.0|1.33|9.09|||||Difference in % = Arm B - Arm C|||9.09|1.33|
91697528|NCT01953601|183289384|OTHER||Difference in % vs Placebo|2.08|||||TWO_SIDED|95.0|-0.84|5.1|||||Difference in % = Arm A - Arm C|||5.10|-0.84|
91697529|NCT01953601|183289384|OTHER||Difference in % vs Placebo|5.58|||||TWO_SIDED|95.0|2.35|8.99|||||Difference in % = Arm B - Arm C|||8.99|2.35|
91697530|NCT01953601|183289385|OTHER||Difference in % vs Placebo|-6.79|||||TWO_SIDED|95.0|-16.16|2.68|||||Difference in % = Arm A - Arm C|||2.68|-16.16|
91697531|NCT01953601|183289385|OTHER||Difference in % vs Placebo|-10.68|||||TWO_SIDED|95.0|-20.16|-1.04|||||Difference in % = Arm B - Arm C|||-1.04|-20.16|
91697532|NCT01953601|183289386|OTHER||Difference in % vs Placebo|-2.42|||||TWO_SIDED|95.0|-6.03|0.61|||||Difference in % = Arm A - Arm C|||0.61|-6.03|
91697533|NCT01953601|183289386|OTHER||Difference in % vs Placebo|-2.38|||||TWO_SIDED|95.0|-6.01|0.71|||||Difference in % = Arm B - Arm C|||0.71|-6.01|
91697534|NCT01953601|183289387|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.0222|TWO_SIDED|97.51|1.005|1.684|||Regression, Cox||HR = Arm A / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.684|1.005|0.0222
91729210|NCT00425854|183354078|SUPERIORITY_OR_OTHER||Clinical benefit rate|0.1|||||TWO_SIDED|95.0|0.02|0.27|||Maxium Likelihood||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI.|||0.27|0.02|
91729211|NCT01725308|183354089|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.4||||0.034|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|||An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.||-0.2|-4.7|0.034
91729212|NCT01725308|183354096|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.7||||0.033|TWO_SIDED|95.0|-3.3|-0.1|||ANCOVA|||At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.||-0.1|-3.3|0.033
91729213|NCT00562861|183354165|SUPERIORITY_OR_OTHER||F value|1.88||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
91729214|NCT00655356|183354168|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
91697535|NCT01953601|183289387|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.005|TWO_SIDED|97.51|1.067|1.79|||Regression, Cox||HR = Arm B / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.790|1.067|0.0050
91697536|NCT01953601|183289388|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9109|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.9109
91729215|NCT00655356|183354169|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.0075
91729216|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993||95% confidence interval is used instead of p-value.|Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
91729217|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.17|-0.25|
91729218|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
91729219|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.03|||||TWO_SIDED|95.0|-0.24|0.18|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.18|-0.24|
91729220|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.995|||||TWO_SIDED|95.0|0.99|1.0|||Passing-Bablock|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||1.000|0.990|
91729221|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.3|0.01|||Passing-Bablok|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.||0.01|-0.30|
91729222|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|Described previously|Relative Sensitivity, %|100.0|||||TWO_SIDED|95.0|85.8|100.0|||||95% confidence interval is used instead of p-value.|Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.||100|85.8|
91729223|NCT01623154|183354173|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously|Relative Specificity, %|100.0|||||TWO_SIDED|95.0|94.9|100.0|||||95% confidence interval is used instead of p-value.|||100|94.9|
91729224|NCT04349098|183354175|SUPERIORITY||Odds Ratio (OR)|0.84||||0.675|TWO_SIDED|95.0|0.39|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.39|0.6750
91729225|NCT02151604|183354194|OTHER||Pearson's coefficient|-0.57||||0.041|TWO_SIDED||||||Pearson's correlation analysis|||Correlation with field of irradiation||||0.041
91729226|NCT02151604|183354196|OTHER||Pearson's coefficient|0.6||||0.037|TWO_SIDED|||||Pearson's correlation coefficient: 0.60|Pearson's Correlation Analysis|0.60||Correlation of change in ventilation signal with that of alveolar volume (VA)||||0.037
91729227|NCT02151604|183354196|OTHER||Pearson's correlation coefficient|0.7||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient: 0.70||Correlation of change in ventilation signal with that of diffusing capacity for carbon monoxide(TLCO)||||0.012
91729228|NCT02151604|183354196|OTHER||Pearson's correlation coefficient|-0.85||||0.032|TWO_SIDED||||||Pearson's correlation analysis|R = -0.85||Correlation of change in ventilation signal with that of residual volume (RV)||||0.032
91729229|NCT02151604|183354196|OTHER||Pearson's correlation coefficient|-0.95||||0.004|TWO_SIDED||||||Pearson's correlation analysis|R = -0.95||Correlation of change in ventilation signal with that of functional residual capacity (FRC)||||0.004
91729230|NCT02151604|183354196|OTHER||Pearson's correlation coefficient|-0.88||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient = -0.88||Correlation of change in ventilation signal with that of inspiratory capacity(IC)||||0.012
91729231|NCT00561821|183354214|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729232|NCT00561821|183354214|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729233|NCT00561821|183354214|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729234|NCT00561821|183354215|SUPERIORITY_OR_OTHER|||||||0.0146||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0146
91729235|NCT00561821|183354215|SUPERIORITY_OR_OTHER|||||||0.0234||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0234
91729236|NCT00561821|183354215|SUPERIORITY_OR_OTHER|||||||0.0102||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0102
91729237|NCT00561821|183354216|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729238|NCT00561821|183354216|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729239|NCT00561821|183354216|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729240|NCT00561821|183354217|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.001
91729241|NCT00561821|183354217|SUPERIORITY_OR_OTHER|||||||0.0213||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0213
91729242|NCT00561821|183354217|SUPERIORITY_OR_OTHER|||||||0.0135||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0135
91729243|NCT00561821|183354218|SUPERIORITY_OR_OTHER|||||||0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0001
91729244|NCT00561821|183354218|SUPERIORITY_OR_OTHER|||||||0.0003||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0003
91729245|NCT00561821|183354218|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729246|NCT00561821|183354219|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729247|NCT00561821|183354219|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729248|NCT00561821|183354219|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729249|NCT00561821|183354220|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729250|NCT00561821|183354220|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729251|NCT00561821|183354220|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729252|NCT00561821|183354221|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91491431|NCT02200211|182855392|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).||0.53||
91528389|NCT02564055|182932073|OTHER||Difference in percentages|6.0|||||TWO_SIDED|95.0|-35.8|47.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||47.1|-35.8|
91528390|NCT02564055|182932073|OTHER||Difference in percentages|-13.6|||||TWO_SIDED|95.0|-54.0|31.2|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||31.2|-54.0|
91729253|NCT00561821|183354221|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729254|NCT00561821|183354221|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729255|NCT00561821|183354222|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729256|NCT00561821|183354222|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729257|NCT00561821|183354222|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729258|NCT00561821|183354223|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729259|NCT00561821|183354223|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729260|NCT00561821|183354223|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729261|NCT00561821|183354224|SUPERIORITY_OR_OTHER|||||||0.6317||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6317
91729262|NCT00561821|183354224|SUPERIORITY_OR_OTHER|||||||0.6355||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6355
91729263|NCT00561821|183354224|SUPERIORITY_OR_OTHER|||||||0.7865||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.7865
91528391|NCT02564055|182932073|OTHER||Difference in percentages|-25.6|||||TWO_SIDED|95.0|-65.3|22.4|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||22.4|-65.3|
91729264|NCT00561821|183354225|SUPERIORITY_OR_OTHER|||||||0.4033||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4033
91729265|NCT00561821|183354225|SUPERIORITY_OR_OTHER|||||||0.4153||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4153
91729266|NCT00561821|183354225|SUPERIORITY_OR_OTHER|||||||0.6271||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6271
91528392|NCT02564055|182932073|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||42.7|-44.5|
91729267|NCT00561821|183354226|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729268|NCT00561821|183354226|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729269|NCT00561821|183354226|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
91729270|NCT00561821|183354227|SUPERIORITY_OR_OTHER|||||||0.0243||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0243
91729271|NCT00561821|183354227|SUPERIORITY_OR_OTHER|||||||0.0242||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0242
91729272|NCT00561821|183354227|SUPERIORITY_OR_OTHER|||||||0.0007||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0007
91697537|NCT01953601|183289388|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.3||||0.0824|TWO_SIDED|97.51|-0.1|0.7|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.7|-0.1|0.0824
91697538|NCT01953601|183289389|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.951|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9510
91697539|NCT01953601|183289389|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9392|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9392
91697540|NCT01953601|183289390|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.4||||0.1133|TWO_SIDED|97.51|-1.0|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-1.0|0.1133
91697541|NCT01953601|183289390|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.6||||0.031|TWO_SIDED|97.51|-1.2|0.0|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.0|-1.2|0.0310
91697542|NCT01953601|183289391|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.05|||<|0.0001|TWO_SIDED|97.51|-0.06|-0.04|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.04|-0.06|<0.0001
91697543|NCT01953601|183289391|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.06|||<|0.0001|TWO_SIDED|97.51|-0.07|-0.05|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.05|-0.07|<0.0001
91697544|NCT01953601|183289392|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.0||||0.096|TWO_SIDED|97.51|-2.4|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-2.4|0.0960
91697545|NCT01953601|183289392|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.7||||0.011|TWO_SIDED|97.51|-3.2|-0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.2|-3.2|0.0110
91697546|NCT01246349|183289394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.616|STANDARD_ERROR_OF_MEAN|7.373||0.24|TWO_SIDED|95.0|-5.871|23.103|||Regression, Linear|||Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[WEL\] change between the treatment and control groups from baseline to a 6 month follow-up).||23.103|-5.871|0.24
91697547|NCT01246349|183289395|SUPERIORITY_OR_OTHER|||||||0.56|||||||Regression, Linear|||Results published comprise baseline and follow-up BMI z-score means and standard deviations for both the MI and control groups (reported above), as well as the attributable effect of intervention (i.e., the difference in BMI change between the treatment and control groups from baseline to a 6-month follow-up)||||0.56
91697548|NCT01246349|183289396|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||Results published comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the attributable effect of intervention (i.e., the difference in waist circumference change between the treatment and control groups from baseline to a 6-month follow-up).||||0.09
91697549|NCT01246349|183289398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|1.265||0.88|TWO_SIDED|95.0|-2.301|2.668|||Regression, Linear|||"Based on previous research , baseline CDSS means were expected between 5 - 6.5 with a SD of 3 - 4. It was hypothesized that an attributable effect of 1.5 would be detected.~Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[CDSS\] change between the treatment and control groups from baseline to a 6 month follow-up)."||2.668|-2.301|0.88
91528393|NCT02564055|182932073|OTHER||Difference in percentages|5.6|||||TWO_SIDED|95.0|-37.8|47.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||47.3|-37.8|
91697550|NCT02991729|183289399|NON_INFERIORITY|The non-inferiority limit was 1 point on the questionnaire scale.||||||0.929||||||a priori threshold for statistical significance was p\<0.05.|Wilcoxon rank-sum|||||||0.929
91528394|NCT02564055|182932073|OTHER||Difference in percentages|-5.5|||||TWO_SIDED|95.0|-47.9|37.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||37.6|-47.9|
91528395|NCT02564055|182932073|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-48.3|41.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||41.5|-48.3|
91528396|NCT02564055|182932073|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||42.7|-44.5|
91697551|NCT02991729|183289400|SUPERIORITY|||||||0.369|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion but prior to genetic counseling (first row, second column in above table).||||0.369
91697552|NCT02991729|183289400|SUPERIORITY|||||||0.003|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion and genetic counseling (second row, second column in above table).||||0.003
91697553|NCT02991729|183289400|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict pre-genetic counseling/post-decision aid to post-genetic counseling.||||0.003
91697554|NCT05537441|183289403|SUPERIORITY||Percent Difference|0.64||||0.216|TWO_SIDED||||||2 proportion Z-test|||||||0.216
91697555|NCT05537441|183289404|SUPERIORITY||Percent Difference|-0.61||||0.34|TWO_SIDED||||||2 proportion Z-test|||Previously vaccinated||||0.34
91697556|NCT05537441|183289404|SUPERIORITY||Percent Difference|-0.45||||0.247|TWO_SIDED||||||2 proportion Z-test|||Previously unvaccinated||||0.247
91697557|NCT01905553|183289405|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.77||||||||0.770|0.670|
91697558|NCT01905553|183289406|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.769||||||||0.769|0.670|
91697559|NCT01905553|183289407|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.449|||||TWO_SIDED|90.0|0.38|0.53||||||||0.530|0.380|
91697560|NCT05225298|183289411|OTHER|||||||0.9||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.90
91697561|NCT05225298|183289412|OTHER|||||||0.94||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.94
91697562|NCT05225298|183289413|OTHER|||||||0.053|||||||log binomial model|||||||0.053
91697563|NCT03962790|183289415|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the credible interval (CrI) of the mean difference between Test and Control was greater than -5.|Posterior Mean Difference|0.09|STANDARD_DEVIATION|2.281|||TWO_SIDED|95.0|-4.37|4.65|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||4.65|-4.37|
91697564|NCT03962790|183289416|NON_INFERIORITY|Non-inferiority is established if the lower limit of the 95% credible interval is above -5 points in CLUE Scale.|Posterior Mean Difference|-1.02|STANDARD_DEVIATION|1.565|||TWO_SIDED|95.0|-4.07|2.06|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||2.06|-4.07|
91697565|NCT03962790|183289417|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.001|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|-0.012|0.01|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.010|-0.012|
91697566|NCT03962790|183289417|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.002|STANDARD_DEVIATION|0.0057|||TWO_SIDED|95.0|-0.014|0.009|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.009|-0.014|
91697567|NCT03962790|183289418|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the CrI of the mean difference between Test and Control was greater than -1.|Posterior Mean Difference|0.02|STANDARD_DEVIATION|0.168|||TWO_SIDED|95.0|-0.32|0.34|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.34|-0.32|
91697568|NCT02877095|183289419|OTHER|||||||||||||||||All subjects on study received active drug.|Total count of events is provided.|||
91697569|NCT02223650|183289420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.01|TWO_SIDED|95.0|-1.42|-0.07||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment|Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group|||-0.07|-1.42|0.01
91697570|NCT02223650|183289421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.14|TWO_SIDED|95.0|-0.68|0.19||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|||0.19|-0.68|0.14
91491432|NCT02200211|182855392|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.55|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).||0.55||
91491433|NCT02200211|182855392|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.04|0.58|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.|Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.||0.58|0.04|
91491434|NCT02200211|182855394|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.082|TWO_SIDED|95.0|-5.7|0.3||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANCOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.||0.3|-5.7|0.082
91491435|NCT02200211|182855394|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.9|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).||0.5|-5.9|
91528397|NCT02564055|182932073|OTHER||Difference in percentages|8.3|||||TWO_SIDED|95.0|-35.0|49.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||49.2|-35.0|
91697571|NCT02223650|183289424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0||||0.07|TWO_SIDED|95.0|-6.0|45.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||45|-6|0.07
91528398|NCT02564055|182932073|OTHER||Difference in percentages|-3.3|||||TWO_SIDED|95.0|-46.0|42.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||42.3|-46.0|
91528399|NCT04542226|182932097|OTHER||||||<|1e-07||||||the a priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test for repeated measures was used to compare with baseline.||||||<0.0000001
91697572|NCT02223650|183289432|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.54|TWO_SIDED|95.0|-23.0|24.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||24|-23|0.54
91697573|NCT01767506|183289434|SUPERIORITY||Odds Ratio (OR)|2.6|||>|0.05|TWO_SIDED|95.0|0.56|11.9|||Regression, Logistic||||The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.|11.9|0.56|>0.05
91697574|NCT01767506|183289435|SUPERIORITY||Mean Difference (Final Values)|3.9||||1|TWO_SIDED||||||Fisher Exact|||||||1
91697575|NCT01608087|183289437|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|96.58|||||TWO_SIDED|93.93|88.54|105.35|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|105.35|88.54|
91697576|NCT01608087|183289437|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.68|||||TWO_SIDED|93.93|83.5|100.65|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.65|83.50|
91697577|NCT01608087|183289437|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|94.92|||||TWO_SIDED|93.93|87.14|103.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|103.40|87.14|
91697578|NCT01608087|183289438|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|98.96|||||TWO_SIDED|90.0|90.97|107.64|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|107.64|90.97|
91697579|NCT01608087|183289438|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.67|||||TWO_SIDED|90.0|84.02|100.01|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.01|84.02|
91491436|NCT02200211|182855394|SUPERIORITY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.9|0.3|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).||0.3|-5.9|
91491437|NCT02200211|182855394|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-5.0|1.2|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).||1.2|-5.0|
91491438|NCT02200211|182855394|SUPERIORITY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.5|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).||0.5|-5.5|
91491439|NCT02200211|182855394|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.7|0.4|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.||0.4|-5.7|
91491440|NCT02200211|182855398|SUPERIORITY||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-4.0|13.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (treated as a continuous covariate).||13|-4|
91491441|NCT02200211|182855398|SUPERIORITY||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-31.0|2.0|||||Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.||2|-31|
91491442|NCT02200211|182855399|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.0|5.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (20/40, 20/50 or worse).||5|-1|
91491443|NCT02200211|182855400|SUPERIORITY|||||||0.83||||||For testing the interaction term, the a priori threshold for statistical significance was 0.05.|ANCOVA|Previously described above in the Statistical Analysis Overview section.||A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p\>0.05), no further comparisons would be performed.||||0.83
91729273|NCT00561821|183354228|SUPERIORITY_OR_OTHER|||||||0.0199||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0199
91491444|NCT02200211|182855401|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.|ANCOVA|Previously described in the Statistical Analysis Overview.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.83
91491445|NCT02200211|182855401|SUPERIORITY|||||||0.54||||||The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.|ANCOVA|Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.54
91528400|NCT00919893|182932108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated."||||<0.05
91729274|NCT00561821|183354228|SUPERIORITY_OR_OTHER|||||||0.0316||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0316
91729275|NCT00561821|183354228|SUPERIORITY_OR_OTHER|||||||0.0014||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0014
91729276|NCT05170061|183354255|SUPERIORITY|||||||0.05||||||see above|t-test, 2 sided|paired analysis||Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)||||0.05
91729277|NCT05170061|183354256|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||||||0.05
91491446|NCT02200211|182855401|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.||||0.80
91528401|NCT01580098|182932115|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.025
91729278|NCT05170061|183354257|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729279|NCT05170061|183354258|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729280|NCT05170061|183354259|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729281|NCT05170061|183354260|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729282|NCT05170061|183354261|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729283|NCT05170061|183354262|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729284|NCT05170061|183354263|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729285|NCT05170061|183354264|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729286|NCT05170061|183354265|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91491447|NCT02200211|182855401|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.||||0.99
91729287|NCT05170061|183354266|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729288|NCT05170061|183354267|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729289|NCT05170061|183354268|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729290|NCT05170061|183354269|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729291|NCT05170061|183354270|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729292|NCT05170061|183354271|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729293|NCT05170061|183354272|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729294|NCT05170061|183354273|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729295|NCT05170061|183354274|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729296|NCT05170061|183354275|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729297|NCT05170061|183354276|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
91729298|NCT03443401|183354284|SUPERIORITY||Mean Difference (Net)|80.0||||0.004|TWO_SIDED|||||level of significance at \<0.05|Spearman's rho|||||||0.004
91528402|NCT01580098|182932116|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Blood pressure: diastolic||||0.182
91729299|NCT03443401|183354285|SUPERIORITY||Mean Difference (Net)|80.0||||0.027|TWO_SIDED|||||Level of significance \<0.05|Spearman's rho|||||||0.027
91729300|NCT00530257|183354295|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of \<=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen's d= \>0.655)|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.01
91729301|NCT00530257|183354296|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch Walk, Don't Walk||||<0.01
91729302|NCT00530257|183354297|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||This p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.05
91729303|NCT00530257|183354299|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||We did not correct for multiple comparisons|t-test, 2 sided|We used a paired t-test||A paired t-test was used to compare the medication versus placebo.||||<0.05
91729304|NCT00530257|183354301|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk.|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
91729305|NCT00530257|183354302|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The p value adjusts for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||<0.01
91729306|NCT00530257|183354303|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
91729307|NCT00530257|183354304|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
91729308|NCT00530257|183354305|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
91729309|NCT00530257|183354306|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
91729310|NCT04392362|183354321|NON_INFERIORITY|The non-inferiority margin or delta was calculated as -0.12(-12%)|Risk Ratio (RR)|0.89||||0.8982|ONE_SIDED|95.0||||0.05 was the level of significance|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the AHA method is inferior to the SIM method but not lower than a pre calculated noninferiority delta of -0.12 (-12 %) and a 95% one sided confidence interval. Only 33 (instead of 151 for a power of 95%) patients could be enrolled with 25 in the SIM and 8 in the AHA arms, which resulted in an estimated power test of 59.08%.||||0.8982
91729311|NCT03160573|183354335|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Flavored Rinse, Placebo Flavored Rinse||||<0.00001
91729312|NCT03160573|183354335|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Unflavored Rinse, Placebo Unflavored Rinse||||<0.00001
91729313|NCT02336555|183354343|SUPERIORITY||Mean Difference (Final Values)|-0.452||||0.075|TWO_SIDED|95.0|-1.076|0.172||Linear mixed model with a posterior probability evaluation for the treatment effect|Linear mixed model|One-sided p-value and a posterior probability greater than 90% that the treatment effect is less than 0.||||0.172|-1.076|0.075
91729314|NCT02336555|183354344|SUPERIORITY||Odds Ratio (OR)|1.073|||||TWO_SIDED|95.0|0.446|2.58|||||Logistic regression model with factors for treatment \& baseline pain intensity|||2.580|0.446|
91729315|NCT01537432|183354345|SUPERIORITY_OR_OTHER||difference in proportions|0.565|||<|0.001|TWO_SIDED|95.0|0.363|0.768|||Fisher Exact|||||0.768|0.363|<0.001
91729316|NCT03704922|183354361|OTHER|||||||0.051|||||||Fisher Exact|||||||0.051
91729317|NCT03093246|183354366|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
91729318|NCT03093246|183354367|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
91729319|NCT03093246|183354368|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
91729320|NCT00830336|183354457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|103.08||||||90.0|95.41|111.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.37|95.41|
91729321|NCT00830336|183354458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|105.84||||||90.0|99.33|112.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.77|99.33|
91729322|NCT00830336|183354459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|107.04||||||90.0|99.96|114.62|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114.62|99.96|
91729323|NCT00835549|183354465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|94.8|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|94.8|
91729324|NCT00835549|183354466|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.5|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.5|
91729325|NCT00835549|183354467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.7|
91729326|NCT04526158|183354468|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.031|TWO_SIDED|95.0|0.0|0.6||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|0.0|0.031
91491448|NCT02200211|182855401|SUPERIORITY|||||||0.87||||||The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.87
91729327|NCT04526158|183354468|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED|95.0|-0.7|-0.2||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|0.002
91729328|NCT04526158|183354468|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-1.0|<0.001
91729329|NCT04526158|183354469|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.736|TWO_SIDED|95.0|-0.2|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.2|0.736
91729330|NCT04526158|183354469|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.6|<0.001
91729331|NCT04526158|183354469|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|<0.001
91729332|NCT04526158|183354470|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.829|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.4|0.829
91491449|NCT02200211|182855401|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.33
91491450|NCT02200211|182855401|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.23
91491451|NCT02200211|182855406|SUPERIORITY|||||||0.66||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.66
91491452|NCT02200211|182855406|SUPERIORITY|||||||0.83||||||A priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.83
91491453|NCT02200211|182855407|SUPERIORITY|||||||0.19||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.19
91729333|NCT04526158|183354470|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.005|TWO_SIDED|95.0|0.2|0.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.9|0.2|0.005
91729334|NCT04526158|183354470|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.004|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.0|0.2|0.004
91729335|NCT04526158|183354471|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.079|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.8|0.0|0.079
91729336|NCT04526158|183354471|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.296|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.2|-0.6|0.296
91729337|NCT04526158|183354471|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.0|0.005
91729338|NCT04526158|183354472|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.464|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.7|-0.3|0.464
91729339|NCT04526158|183354472|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.019|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.1|-1.1|0.019
91729340|NCT04526158|183354472|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.002|TWO_SIDED|95.0|-1.3|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.3|0.002
91729341|NCT04526158|183354473|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.5|0.889
91729342|NCT04526158|183354473|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.004|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.004
91729343|NCT04526158|183354473|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.006|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.006
91729344|NCT04526158|183354474|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.76|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.5|-0.4|0.76
91729345|NCT04526158|183354474|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.4|0.6|<0.001
91729346|NCT04526158|183354474|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.5|1.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.3|0.5|<0.001
91729347|NCT04526158|183354475|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|-0.7|0.89
91729348|NCT04526158|183354475|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.5|0.003
91729349|NCT04526158|183354475|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.007|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.5|0.007
91729350|NCT04526158|183354476|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.886|TWO_SIDED|95.0|-1.6|1.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.9|-1.6|0.886
91729351|NCT04526158|183354476|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.017|TWO_SIDED|95.0|-3.7|-0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-3.7|0.017
91729352|NCT04526158|183354476|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.013|TWO_SIDED|95.0|-3.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-3.9|0.013
91729353|NCT04526158|183354477|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.437|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.1|0.437
91729354|NCT04526158|183354477|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-0.9|<0.001
91729355|NCT04526158|183354477|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.6|-1.0|<0.001
91491454|NCT02200211|182855407|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.69
91729356|NCT04526158|183354478|SUPERIORITY||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-13.9|-1.2||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-1.2|-13.9|
91729357|NCT04526158|183354478|SUPERIORITY||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|6.4|17.6||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||17.6|6.4|
91729358|NCT04526158|183354478|SUPERIORITY||Mean Difference (Final Values)|19.5|||||TWO_SIDED|95.0|13.6|25.4||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||25.4|13.6|
91729359|NCT00677040|183354479|EQUIVALENCE|t-test to determine if tissue oxygen measurements are equivalent between treated and nontreated breast|t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
91729360|NCT00677040|183354479|OTHER||t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.5
91491455|NCT02200211|182855413|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.02|0.3|||||A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.|The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.||0.30|0.02|
91729361|NCT01725282|183354481|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-3.1|3.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||3.6|-3.1|
91729362|NCT01725282|183354481|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.0|2.8|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||2.8|-4.0|
91729363|NCT01725282|183354481|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-2.1|4.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||4.6|-2.1|
91729364|NCT04576481|183354492|SUPERIORITY||F-Statistic|1.18||||0.32|TWO_SIDED||||||ANOVA|||Analysis of Variance statistical testing.||||0.32
91729365|NCT04576481|183354493|SUPERIORITY||F-Statistic|0.25||||0.78|TWO_SIDED||||||ANOVA|||||||0.78
91729366|NCT04576481|183354494|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
91729367|NCT04576481|183354495|SUPERIORITY|||||||0.46|||||||ANOVA|||||||0.46
91729368|NCT04576481|183354496|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
91729369|NCT02739828|183354524|SUPERIORITY|||||||0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0001
91729370|NCT02739828|183354525|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||< 0.0001
91729371|NCT02739828|183354526|SUPERIORITY|||||||0.0004|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
91729372|NCT02739828|183354527|SUPERIORITY|||||||0.0005|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0005
91729373|NCT02739828|183354527|SUPERIORITY|||||||0.0006|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0006
91729374|NCT02739828|183354528|SUPERIORITY|||||||0.0004|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
91729375|NCT02739828|183354528|SUPERIORITY|||||||0.0016|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0016
91729376|NCT02739828|183354529|SUPERIORITY|||||||0.0003|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0003
91729377|NCT02739828|183354529|SUPERIORITY|||||||0.0094|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0094
91491456|NCT02200211|182855414|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-1.1|1.3|||||A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.||1.3|-1.1|
91491457|NCT02200211|182855415|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.32
91491458|NCT02200211|182855415|SUPERIORITY|||||||0.68|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.68
91729378|NCT02739828|183354533|SUPERIORITY|||||||0.0278|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0278
91729379|NCT02739828|183354534|SUPERIORITY|||||||0.0215|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0215
91729380|NCT02739828|183354535|SUPERIORITY|||||||0.1652|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1652
91729381|NCT02739828|183354539|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
91729382|NCT02739828|183354540|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
91729383|NCT02739828|183354541|SUPERIORITY|||||||0.5|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.5000
91729384|NCT02739828|183354542|SUPERIORITY|||||||0.1797|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1797
91729385|NCT02739828|183354543|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
91729386|NCT02739828|183354544|SUPERIORITY|||||||0.0313|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0313
91729387|NCT02739828|183354545|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
91729388|NCT02739828|183354546|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
91729389|NCT02739828|183354547|SUPERIORITY|||||||0.0156|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0156
91729390|NCT02739828|183354548|SUPERIORITY|||||||0.0386|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0386
91729391|NCT02739828|183354549|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
91729392|NCT02739828|183354550|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
91729393|NCT02739828|183354551|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
91729394|NCT02739828|183354552|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
91729395|NCT02739828|183354553|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
91729396|NCT04191733|183354579|NON_INFERIORITY|The non-inferiority analysis was demonstrated when the 1-sided upper 95% confidence interval (CI) limit was less than 1.25.|||||<|0.0001||||||one-sided p-value|t-test, 1 sided|||||||<0.0001
91729397|NCT04191733|183354580|NON_INFERIORITY|1-sided test with 5% alpha was used to demonstrate non-inferiority with greater than 99% power. The non-inferiority margin was 3.75 minutes.||||||0.1004|||||||t-test, 1 sided|||A gatekeeping strategy was used to control family-wise type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The testing sequence continued only when previous endpoint was statistically significant with a 1-sided alpha of 0.05.||||0.1004
91729398|NCT02349477|183354599|SUPERIORITY||Odds Ratio (OR)|3.9||||0.028|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.||||.028
91729399|NCT02349477|183354600|SUPERIORITY||Odds Ratio (OR)|4.9||||0.053|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.||||.053
91729400|NCT02349477|183354601|SUPERIORITY|||||||0.001|||||||Chi-squared|||For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.001
91729401|NCT02349477|183354601|SUPERIORITY|||||||0.67|||||||Chi-squared|||For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.67
91729402|NCT02202577|183354602|SUPERIORITY||Risk Ratio (RR)|0.9||||0.38|ONE_SIDED|95.0||1.35||This is the calculated p-value for the intention to treat analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||"We estimated a cesarean related surgical site infection rate of 7.5% with povidone-iodine and hypothesized chlorhexidine-alcohol treatment to be superior based on existing literature. We considered a 50% reduction to be significant. We performed our power analysis assuming~1-directional effects in favor of chlorhexidine, which best fit our hypothesis. Using a 1-tailed alpha of 0.05 and an 80% power to detect a difference, we estimated that 466 subjects would be required in each group."||1.35||0.38
91729403|NCT02202577|183354602|SUPERIORITY||Risk Ratio (RR)|0.83||||0.26|ONE_SIDED|95.0||1.25||This is the calculated p-value for the per protocol analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||Per Protocol Analysis||1.25||0.26
91729404|NCT01714063|183354604|OTHER|We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter|||||<|0.001|||||||paired t-test|||||||<0.001
91729405|NCT00563316|183354619|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.894|1.074|||||Ratio of Cycle 2 : Cycle 1|||1.074|0.894|
91729406|NCT00563316|183354620|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.819|0.985|||||Ratio of Cycle 2 : Cycle 1|||0.985|0.819|
91729407|NCT00563316|183354621|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.897|||||TWO_SIDED|90.0|0.818|0.983|||||Ratio of Cycle 2 : Cycle 1|||0.983|0.818|
91491459|NCT02200211|182855416|SUPERIORITY|||||||0.17|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||0.17
91491460|NCT02200211|182855416|SUPERIORITY|||||||0.48|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.48
91729408|NCT03511209|183354626|SUPERIORITY||Odds Ratio (OR)|2.13|STANDARD_ERROR_OF_MEAN|0.85||0.056|TWO_SIDED|95.0|0.98|4.64|||Regression, Logistic|||Compared CBTI plus Taper method A to CBTI plus Taper method B||4.64|0.98|0.056
91729409|NCT03511209|183354627|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.27||0.405|TWO_SIDED|95.0|-3.57|1.44|||Mixed Models Analysis|Interaction contrast of Treatment Group (CBTI plus Taper method A vs. CBTI plus Taper method B) by Time (6 Months vs. Baseline)||||1.44|-3.57|0.405
91729410|NCT02628145|183354628|OTHER||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
91729411|NCT02628145|183354629|SUPERIORITY|||||||0.88|||||||Chi-squared|||||||0.88
91729412|NCT02628145|183354630|SUPERIORITY|||||||0.068|||||||Fisher Exact|||||||0.068
91729413|NCT02628145|183354631|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
91729414|NCT02628145|183354632|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
91729415|NCT02628145|183354633|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91729416|NCT02628145|183354634|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91729417|NCT02628145|183354635|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91729418|NCT02628145|183354636|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91729419|NCT02628145|183354638|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
91729420|NCT02757963|183354641|OTHER||Proportion|0.883|||||TWO_SIDED|95.0|0.849|0.912|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|||0.912|0.849|
91729421|NCT02757963|183354642|OTHER||Proportion|0.877|||||TWO_SIDED|95.0|0.846|0.904|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.904|0.846|
91729422|NCT02757963|183354642|OTHER||Proportion|0.889|||||TWO_SIDED|95.0|0.854|0.917|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.917|0.854|
91729423|NCT02757963|183354642|OTHER||Proportion|0.873|||||TWO_SIDED|95.0|0.843|0.9|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.900|0.843|
91729424|NCT02757963|183354643|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.926|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.926|0.870|
91729425|NCT02757963|183354643|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.934|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.934|0.873|
91729426|NCT02757963|183354643|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.935|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.935|0.873|
91729427|NCT02757963|183354643|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.925|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm PSS \>=8 or BPE/BPO \>=3||0.925|0.870|
91491461|NCT02200211|182855416|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
91491462|NCT02200211|182855416|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
91697580|NCT01608087|183289438|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|92.63|||||TWO_SIDED|90.0|85.18|100.74|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.74|85.18|
91697581|NCT01608087|183289439|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|101.53|||||TWO_SIDED|90.0|92.74|111.14|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|111.14|92.74|
91697582|NCT01608087|183289439|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|93.25|||||TWO_SIDED|90.0|87.12|99.81|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|99.81|87.12|
91697583|NCT01608087|183289439|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.85|||||TWO_SIDED|90.0|83.91|100.54|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least square estimates of log-transformed PK endpoint for R1 and R2 were back transformed to original scale to get adjusted point estimator and interval estimates for the inter-subject ratio of the geometric means for treatments.|100.54|83.91|
91697584|NCT00908791|183289454|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|exact McNemar test for paired binary data.||||||0.003
91697585|NCT00908791|183289455|SUPERIORITY_OR_OTHER|||||||0.41|||||||McNemar|||||||0.41
91697586|NCT00908791|183289456|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||bowker's test of symmetry|||||||0.48
91697587|NCT00908791|183289457|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|95.0|||||Sign test|||The Sign-Rank test for paired data.||||0.029
91697588|NCT00908791|183289458|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||||||0.62
91729428|NCT02757963|183354644|OTHER||Proportion|0.362|||||TWO_SIDED|95.0|0.337|0.386|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.386|0.337|
91697589|NCT00908791|183289459|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
91697590|NCT00908791|183289460|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
91697591|NCT00722566|183289534|NON_INFERIORITY_OR_EQUIVALENCE|Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.|ORR_SQ - 0.6 ORR_IV|16.8||||0.00201|TWO_SIDED|95.0|6.1|27.1|||Farrrington and Manning|CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).||In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).||27.1|6.1|0.00201
91697592|NCT00401544|183289536|SUPERIORITY_OR_OTHER||Percentage of participants|71.0||||||95.0|63.0|80.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||80|63|
91729429|NCT02757963|183354644|OTHER||Proportion|0.368|||||TWO_SIDED|95.0|0.341|0.395|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.395|0.341|
91491463|NCT02200211|182855417|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||0.05
91697593|NCT00401544|183289536|SUPERIORITY_OR_OTHER||Percentage of participants|63.0||||||95.0|54.0|72.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||72|54|
91697594|NCT00401544|183289537|SUPERIORITY_OR_OTHER||Percentage of participants|73.0||||||95.0|64.0|81.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||81|64|
91697595|NCT00401544|183289537|SUPERIORITY_OR_OTHER||Percentage of participants|62.0||||||95.0|54.0|71.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||71|54|
91697596|NCT00401544|183289542|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
91697597|NCT00401544|183289542|SUPERIORITY_OR_OTHER||Percentage of participants|38.0||||||95.0|29.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|29|
91697598|NCT00401544|183289543|SUPERIORITY_OR_OTHER||Percentage of participants|35.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
91697599|NCT00401544|183289543|SUPERIORITY_OR_OTHER||Percentage of participants|39.0||||||95.0|30.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|30|
91697600|NCT00401544|183289544|SUPERIORITY_OR_OTHER||Percentage of participants|26.0||||||95.0|15.0|38.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||38|15|
91697601|NCT00401544|183289544|SUPERIORITY_OR_OTHER||Percentage of participants|31.0||||||95.0|19.0|42.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||42|19|
91697602|NCT00401544|183289544|SUPERIORITY_OR_OTHER||Percentage of participants|28.0||||||95.0|17.0|40.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||40|17|
91697603|NCT00401544|183289544|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|14.0|36.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||36|14|
91491464|NCT02200211|182855417|SUPERIORITY|||||||0.02|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.02
91697604|NCT00401544|183289545|SUPERIORITY_OR_OTHER||Percentage of participants|68.0||||||95.0|59.0|76.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||76|59|
91697605|NCT00401544|183289545|SUPERIORITY_OR_OTHER||Percentage of participants|59.0||||||95.0|50.0|68.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||68|50|
91697606|NCT00401544|183289546|SUPERIORITY_OR_OTHER||Percentage of participants|53.0||||||95.0|44.0|62.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||62|44|
91697607|NCT00401544|183289546|SUPERIORITY_OR_OTHER||Percentage of participants|74.0||||||95.0|66.0|82.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||82|66|
91697608|NCT02780713|183289572|SUPERIORITY||Percentage|17.02|||||TWO_SIDED|95.0|11.79|24.58||||||||24.58|11.79|
91697609|NCT02780713|183289572|SUPERIORITY||Percentage|36.28|||||TWO_SIDED|95.0|23.84|55.2||||||||55.20|23.84|
91697610|NCT02780713|183289572|SUPERIORITY||Percentage|24.1|||||TWO_SIDED|95.0|16.84|34.48||||||||34.48|16.84|
91697611|NCT02780713|183289573|SUPERIORITY||Percentage|31.75|||||TWO_SIDED|95.0|25.77|39.12||||||||39.12|25.77|
91697612|NCT02780713|183289573|SUPERIORITY||Percentage|54.17|||||TWO_SIDED|95.0|42.16|69.6||||||||69.60|42.16|
91697613|NCT02780713|183289573|SUPERIORITY||Pecentage|41.23|||||TWO_SIDED|95.0|34.79|48.86||||||||48.86|34.79|
91697614|NCT01931475|183289591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||||-0.2|-0.80|
91729430|NCT02757963|183354644|OTHER||Proportion|0.377|||||TWO_SIDED|95.0|0.349|0.406|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.406|0.349|
91729431|NCT02757963|183354644|OTHER||Proportion|0.355|||||TWO_SIDED|95.0|0.332|0.379|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.379|0.332|
91729432|NCT02757963|183354645|OTHER||Kappa statistic|0.55|||||TWO_SIDED|95.0|0.51|0.58||||||||0.58|0.51|
91491465|NCT02200211|182855417|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
91491466|NCT02200211|182855417|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
91528403|NCT00345384|182932123|SUPERIORITY_OR_OTHER||Precentage Difference|41.0||||0.03|TWO_SIDED|95.0|||||t-test, 2 sided||The percentage in opioid use by the dexmedetomidine group in comparison to the placebo for the period of time on study drug is calculated as follows: numerator = 29, denominator = 49.|||||0.03
91697615|NCT01931475|183289592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.19||||||||-0.19|-0.54|
91697616|NCT01931475|183289593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||||TWO_SIDED|95.0|-5.62|-1.35|||||Total Score|||-1.35|-5.62|
91697617|NCT01931475|183289593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.21|-0.21|||||Pain|||-0.21|-1.21|
91697618|NCT01931475|183289593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36|||||TWO_SIDED|95.0|-3.95|-0.78|||||Physical Function|||-0.78|-3.95|
91697619|NCT01931475|183289593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.62|-0.16|||||Stiffness|||-0.16|-0.62|
91697620|NCT01931475|183289594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.41|-0.15||||||||-0.15|-0.41|
91697621|NCT01931475|183289595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.07|-0.34|||||BPI Severity of Worst Pain|||-0.34|-1.07|
91697622|NCT01931475|183289595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.6|0.03|||||BPI Severity of Least Pain|||0.03|-0.60|
91697623|NCT01931475|183289595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||BPI Severity of Right Now Pain|||-0.11|-0.82|
91697624|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.53|-0.02|||||BPI Interference Average Score|||-0.02|-0.53|
91697625|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-0.94|-0.19|||||General activity|||-0.19|-0.94|
91697626|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.74|-0.05|||||Mood|||-0.05|-0.74|
91697627|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||Walking ability|||-0.11|-0.82|
91697628|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.68|0.06|||||Normal work (includes both work outside the home and housework)|||0.06|-0.68|
91697629|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.34|0.21|||||Relations with other people|||0.21|-0.34|
91697630|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.57|0.14|||||Sleep|||0.14|-0.57|
91697631|NCT01931475|183289596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.4|0.27|||||Enjoyment of life|||0.27|-0.40|
91697632|NCT01931475|183289598|SUPERIORITY_OR_OTHER||Total Effect|97.49||||0.002|TWO_SIDED||||||Regression, Linear|||Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.||||0.002
91697633|NCT02821338|183289601|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference ratio|0.9863|||||TWO_SIDED|90.0|0.9598|1.0134||||||90% confidence interval of the geometric mean ratio of test/reference||1.0134|0.9598|
91697634|NCT02821338|183289602|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|0.9785|||||TWO_SIDED|90.0|0.9484|1.0095||||||||1.0095|0.9484|
91491467|NCT00621985|182855439|SUPERIORITY_OR_OTHER||Percent Difference|-19.0||||0.09||95.0|||||t-test, 2 sided|||"A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:~(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone"||||0.09
91491468|NCT01001377|182855448|SUPERIORITY_OR_OTHER_LEGACY||Stratified Cox proportional hazard ratio|0.966|||||TWO_SIDED|95.0|0.839|1.113|||||Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.|Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).||1.113|0.839|
91697635|NCT02821338|183289603|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|1.047|||||TWO_SIDED|90.0|1.0079|1.0877||||||||1.0877|1.0079|
91697636|NCT02225860|183289607|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
91697637|NCT02225860|183289608|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
91697638|NCT01250873|183289610|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.17|||||TWO_SIDED|90.0|1.06|1.3|||ANOVA|||||1.30|1.06|
91697639|NCT01250873|183289611|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.14|||||TWO_SIDED|90.0|1.01|1.28|||ANOVA|||||1.28|1.01|
91697640|NCT01250873|183289612|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8281|TWO_SIDED|90.0|-0.5|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-0.50|0.8281
91697641|NCT01250873|183289613|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.27|||||TWO_SIDED|90.0|1.17|1.39|||ANOVA|||||1.39|1.17|
91697642|NCT01250873|183289614|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.22|||||TWO_SIDED|90.0|1.1|1.36|||ANOVA|||||1.36|1.10|
91697643|NCT01250873|183289615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|0.00|0.3125
91697644|NCT00422695|183289685|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91697645|NCT00422695|183289685|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91697646|NCT03514485|183289717|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.34|0.25||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.25|-0.34|
91697647|NCT03514485|183289717|SUPERIORITY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.34|0.18||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.18|-0.34|
91697648|NCT03514485|183289717|SUPERIORITY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.48|0.04||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.04|-0.48|
91697649|NCT03514485|183289717|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.44|0.9||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.9|-0.44|
91697650|NCT03514485|183289717|SUPERIORITY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.36|0.09||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.09|-0.36|
91697651|NCT03514485|183289718|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.39|0.55||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.55|-0.39|
91697652|NCT03514485|183289718|SUPERIORITY||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|0.04|0.88||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.88|0.04|
91697653|NCT03514485|183289718|SUPERIORITY||Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-1.06|-0.23||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.23|-1.06|
91729433|NCT01887600|183354660|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|20.48|58.93|||Cochran-Mantel-Haenszel||Please note Odds Ratio and CI are shown in percentages.|The Cochran-Mantel-Haenszel (CMH) test was adjusted by region, history of of cardiovascular, cerebrovascular or thromboembolic (CV) disease, baseline Hb and baseline estimated glomerular filtration rate (eGFR). Superiority of roxadustat versus placebo was to be declared if the lower bound of the two-sided 95% confidence interval of the CMH odds ratio was higher than 1.||58.93|20.48|<0.001
91729434|NCT01887600|183354661|SUPERIORITY||Least squares mean difference|1.692|||<|0.001||95.0|1.52|1.86|||ANCOVA|||The Analysis of Covariance (ANCOVA) with Multiple Imputations (MI) model, adjusting for covariates was used for the analysis. The model included treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates. Superiority of roxadustat versus placebo was considered successful if the lower bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) was higher than 0.||1.86|1.52|<0.001
91729435|NCT01887600|183354662|SUPERIORITY||Least squares mean difference|1.599|||<|0.001|TWO_SIDED|95.0|1.41|1.78||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit interaction as continuous covariates.||1.78|1.41|<0.001
91491469|NCT01001377|182855448|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.|Normal score|-3.19||||0.0007||||||A synthesis approach with an asymptotic standard normal test statistic|Asymptotic standard normal test|||A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).||||0.0007
91491470|NCT01001377|182855450|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.58|||||Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).|||1.58|0.83|
91697654|NCT03514485|183289718|SUPERIORITY||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-1.39|-0.67||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.67|-1.39|
91697655|NCT03514485|183289718|SUPERIORITY||Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.95|-0.18||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.18|-0.95|
91697656|NCT03514485|183289719|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.53|0.28||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.28|-0.53|
91729436|NCT01887600|183354663|SUPERIORITY|Superiority of roxadustat versus placebo was considered successful if the upper bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) is below 0.|Least squares mean difference|-0.701|||<|0.001||95.0|-0.83|-0.57||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects during the period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb, baseline eGFR and baseline LDL as continuous variables.||-0.57|-0.83|<0.001
91697657|NCT03514485|183289719|SUPERIORITY||Median Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.45|0.26||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.45|
91697658|NCT03514485|183289719|SUPERIORITY||Mean Difference (Net)|-0.25|||||TWO_SIDED|95.0|-0.6|0.1||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.10|-0.60|
91759005|NCT04765202|183411227|SUPERIORITY||Percentage Difference|14.3||||1|TWO_SIDED|95.0|-11.64|40.21|||Fisher Exact||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 1.||40.21|-11.64|1.0000
91697659|NCT03514485|183289719|SUPERIORITY||Median Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.57|0.01||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.01|-0.57|
91697660|NCT03514485|183289719|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.72|-0.04||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.04|-0.72|
91729437|NCT01887600|183354664|SUPERIORITY||Hazard Ratio (HR)|0.238|||<|0.001|TWO_SIDED|95.0|0.17|0.33||Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority is declared if the upper bound of the 95% CI is below 1.0.||0.33|0.17|<0.001
91729438|NCT01887600|183354665|SUPERIORITY||Least squares mean difference|1.127|||=|0.093|TWO_SIDED|95.0|-0.19|2.44||LSM Difference p-value is for test of differences.Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 VT, baseline Hb and baseline eGFR as continuous variables.||2.44|-0.19|=0.093
91729439|NCT01887600|183354666|SUPERIORITY||Least squares mean difference|0.713|||=|0.27|TWO_SIDED|95.0|-0.56|1.98||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 PF, baseline Hb and baseline eGFR as continuous variables.||1.98|-0.56|=0.27
91491471|NCT01001377|182855454|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0126|||||TWO_SIDED|95.0|-0.0353|0.0605|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||0.0605|-0.0353|
91491472|NCT01001377|182855455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6745|||||TWO_SIDED|95.0|-4.9331|1.5841|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||1.5841|-4.9331|
91491473|NCT01001377|182855456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0372|||||TWO_SIDED|95.0|-2.3267|4.401|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.4010|-2.3267|
91491474|NCT01001377|182855457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5836|||||TWO_SIDED|95.0|-3.0269|4.1941|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.1941|-3.0269|
91729440|NCT01887600|183354667|NON_INFERIORITY|Non-inferiority can be concluded if the upper bound of the two-sided 95% CI of the difference between roxadustat and placebo (roxadustat minus placebo) is below 2 mmHg.|Least squares mean difference|0.842|||=|0.182|TWO_SIDED|95.0|-0.4|2.08||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms with overall mean effects throughout the evaluation period (weeks 20 to 28). The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||2.08|-0.40|=0.182
91729441|NCT01887600|183354668|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the 95% CI is below 1.3 (hazard ratio).|Hazard Ratio (HR)|1.29|||=|0.334|TWO_SIDED|95.0|0.77|2.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.16|0.77|=0.334
91729442|NCT01887600|183354669|SUPERIORITY||Least squares mean difference|0.59|||=|0.316|TWO_SIDED|95.0|-0.57|1.75|||Mixed Models Analysis|||Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values adjusted on baseline Hb, region, CV history at Baseline and the interaction terms.||1.75|-0.57|=0.316
91729443|NCT01887600|183354670|SUPERIORITY||Least squares mean difference|1.638|||<|0.001|TWO_SIDED|95.0|1.44|1.84||LSM Difference p-value is for test of differences|Mixed Models Analysis|||Average Level of Hb Over Weeks 28 to 36. A Mixed Model of Repeated Measures was applied using the visits over weeks 28 to 36. The results were based on the estimated difference between the two treatment arms by visit based on this MMRM model. The model included treatment arm, region, CV History, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.84|1.44|<0.001
91729444|NCT01887600|183354671|SUPERIORITY||Least squares mean difference|1.604|||<|0.001|TWO_SIDED|95.0|1.39|1.82||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 44 to 52. A Mixed Model of Repeated Measures was applied using the visits over weeks 44 to 52. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.39|<0.001
91491475|NCT01001377|182855458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1998|||||TWO_SIDED|95.0|-6.0093|5.6098|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||5.6098|-6.0093|
91528404|NCT00345384|182932123|SUPERIORITY_OR_OTHER||Percentage difference|35.0||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided||A measure of opioid use, weighted for total time on study drug. This is examined by a comparison of the dexmedetomidine group to the placebo group: numerator = 35, denominator = 54.|||||0.04
91491476|NCT02849678|182855464|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.148|||||||t-test, 1 sided|||||||0.148
91491477|NCT02849678|182855466|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.636|||||||t-test, 1 sided|||||||.636
91491478|NCT02849678|182855468|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.193||||||Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU)|t-test, 2 sided|||||||0.193
91528405|NCT00345384|182932124|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The p-value reported in this table corresponds with the 6 to 16 hour time frame.||||0.02
91697661|NCT03514485|183289720|SUPERIORITY||Mean Difference (Net)|2.38|||||TWO_SIDED|95.0|0.58|4.19||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||4.19|0.58|
91697662|NCT03514485|183289720|SUPERIORITY||Mean Difference (Net)|4.49|||||TWO_SIDED|95.0|2.54|6.43||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||6.43|2.54|
91697663|NCT03514485|183289720|SUPERIORITY||Mean Difference (Net)|-0.97|||||TWO_SIDED|95.0|-2.78|0.84||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.84|-2.78|
91697664|NCT03514485|183289720|SUPERIORITY||Mean Difference (Net)|-3.07|||||TWO_SIDED|95.0|-5.03|-1.12||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-1.12|-5.03|
91697665|NCT03514485|183289720|SUPERIORITY||Mean Difference (Net)|1.41|||||TWO_SIDED|95.0|-0.48|3.31||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||3.31|-0.48|
91697666|NCT03514485|183289721|SUPERIORITY||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.19|0.54||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.19|
91697667|NCT03514485|183289721|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.28|0.35||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.35|-0.28|
91697668|NCT03514485|183289721|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.68|-0.01||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.01|-0.68|
91729445|NCT01887600|183354672|SUPERIORITY||Least squares mean difference|1.492|||<|0.001|TWO_SIDED|95.0|1.14|1.85||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 96 to 104. A Mixed Model of Repeated Measures was applied using the visits over weeks 96 to 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.85|1.14|<0.001
91729446|NCT01887600|183354673|SUPERIORITY||Hazard Ratio (HR)|19.001|||<|0.001|TWO_SIDED|95.0|11.98|30.15|||Regression, Cox|||Time to Achieve the First Hb Response. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||30.15|11.98|<0.001
91729447|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|0.396|||<|0.001|TWO_SIDED|95.0|0.29|0.5||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 1. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||0.50|0.29|<0.001
91759006|NCT04765202|183411227|SUPERIORITY||Percentage Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 2.||0|0|
91697669|NCT03514485|183289721|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.48|0.08||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.08|-0.48|
91697670|NCT03514485|183289721|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-0.48|0.14||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.14|-0.48|
91697671|NCT03514485|183289722|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.11|0.29||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.11|
91697672|NCT03514485|183289722|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.03|0.34||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.34|-0.03|
91697673|NCT03514485|183289722|SUPERIORITY||Mean Difference (Net)|-0.001|||||TWO_SIDED|95.0|-0.19|0.18||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.19|
91697674|NCT03514485|183289722|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.23|0.09||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.09|-0.23|
91697675|NCT03514485|183289722|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.09|0.26||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.09|
91697676|NCT03514485|183289723|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|0.0|0.65||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.65|0.00|
91697677|NCT03514485|183289723|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.12|0.45||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.45|-0.12|
91697678|NCT03514485|183289723|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.4|0.18||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.40|
91697679|NCT03514485|183289723|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.2|0.29||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.20|
91697680|NCT03514485|183289723|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.08|0.5||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.50|-0.08|
91697681|NCT03514485|183289724|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.19|0.69||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.69|-0.19|
91697682|NCT03514485|183289724|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.14|0.63||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.63|-0.14|
91528406|NCT00365378|182932125|SUPERIORITY_OR_OTHER||Vaccine Efficacy|94.3||||||95.0|87.8|97.7|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.7|87.8|
91759007|NCT04929249|183411229|SUPERIORITY||LS mean difference|-53.0|||<|0.001|TWO_SIDED|97.5|-60.0|-46.0|||Mixed Models Analysis|||||-46.0|-60.0|<0.001
91491479|NCT02849678|182855468|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.635||||||Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours|ANOVA|||||||0.635
91491480|NCT02849678|182855469|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.063|||||||ANOVA|Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours||||||0.063
91697683|NCT03514485|183289724|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.49|0.3||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.30|-0.49|
91513238|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.06||||||95.0|3.68|4.48||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.48|3.68|
91528407|NCT00365378|182932126|SUPERIORITY_OR_OTHER||Vaccine Efficacy|100.0||||||95.0|84.0|100.0|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||100.0|84.0|
91697684|NCT03514485|183289724|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.43|0.24||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.24|-0.43|
91697685|NCT03514485|183289724|SUPERIORITY||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.24|0.54||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.24|
91697686|NCT03075891|183289728|SUPERIORITY|||||||0.032|||||||Cochran-Mantel-Haenszel|||||||0.032
91697687|NCT02461524|183289763|OTHER||Percentage|2.9|||<|0.001|ONE_SIDED|97.5||8.7|||Exact binomial test|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a Major Adverse Event (MAE) within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system and 20% is the safety PG."||8.7||<0.001
91697688|NCT02461524|183289764|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|100.0||||0.001|ONE_SIDED|95.0|95.8||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||95.8|0.001
91697689|NCT02278939|183289830|SUPERIORITY|||||||0.003||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months||||0.003
91697690|NCT02278939|183289831|SUPERIORITY|||||||0.001||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months||||.001
91697691|NCT02278939|183289832|SUPERIORITY|||||||0.002||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months||||.002
91697692|NCT00930774|183289858|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANOVA|df = 3,83; F=0.748||||||0.527
91697693|NCT00930774|183289859|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANOVA|df = 3,83; F=0.286||||||0.835
91729448|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|0.938|||<|0.001|TWO_SIDED|95.0|0.81|1.07||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 2. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.07|0.81|<0.001
91697694|NCT00930774|183289860|SUPERIORITY_OR_OTHER|||||||0.983|||||||ANOVA|df = 3,83; F=0.054||||||0.983
91697695|NCT00930774|183289861|SUPERIORITY_OR_OTHER|||||||0.554||||||df = 3,83; F=0.701|ANOVA|||||||0.554
91697696|NCT00930774|183289862|SUPERIORITY_OR_OTHER|||||||0.757||||||df = 3,83; F=0.395|ANOVA|||||||0.757
91697697|NCT00930774|183289863|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANOVA|df = 3,83; F=1.236||||||0.302
91697698|NCT00930774|183289864|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|df = 3,83. F=6.343||||||0.001
91697699|NCT00930774|183289864|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91697700|NCT00930774|183289865|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANOVA|df = 3,83; F=3.797||||||0.013
91697701|NCT00930774|183289865|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
91697702|NCT00712881|183289896|OTHER|||||||0.154||||||Threshold for significance at 0.05 level.|2-sided, binomial proportions|||||||0.154
91729449|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.471|||<|0.001|TWO_SIDED|95.0|1.3|1.64||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 4. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.64|1.30|<0.001
91729450|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.827|||<|0.001|TWO_SIDED|95.0|1.64|2.02||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 6. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.02|1.64|<0.001
91729451|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|2.058|||<|0.001|TWO_SIDED|95.0|1.87|2.25||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 8. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.25|1.87|<0.001
91729452|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.949|||<|0.001|TWO_SIDED|95.0|1.75|2.14||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 10. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.14|1.75|<0.001
91491481|NCT00289991|182855470|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true success rate of 50% in voriconazole (Vori) treatment (Tx) group and 45% in itraconazole (Itra) Tx group, sample size of 232 subjects per group=90% power to demonstrate non-inferiority of Vori to Itra using pre-specified non-inferiority margin of -10%. Sample has at least 80% power to demonstrate superiority of Vori over Itra if true success rates for Vori and Itra are 57% and 44% respectively. Based on this, up to 500 subjects were to be enrolled to obtain 464 eligible subjects.|percent difference adjusted proportions|16.4|||||TWO_SIDED|95.0|7.7|25.1|||Difference in adjusted responder rates|Difference in adjusted responder rates using Fleiss method|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|"Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant does not include zero and is positive."||25.1|7.7|
91491482|NCT00289991|182855471|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority inferred if lower limit of the 2-sided 95% confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant does not include zero and is positive."|percent difference adjusted proportions|15.4|||||TWO_SIDED|95.0|6.6|24.2|||Difference in adjusted responder rates|Difference in adjusted responder rates using the Fleiss method.|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|||24.2|6.6|
91491483|NCT00289991|182855473|SUPERIORITY_OR_OTHER||difference in proportions: percent|-0.4||||0.7114|TWO_SIDED|95.0|-2.2|1.5|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 100; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.5|-2.2|0.7114
91491484|NCT00289991|182855473|SUPERIORITY_OR_OTHER||difference in proportion: percent|-0.3||||0.7759|TWO_SIDED|95.0|-2.5|1.9|||Difference in proportions|Difference in proportions (approximate result).|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.9|-2.5|0.7759
91729453|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.9|2.28||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 12. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.28|1.90|<0.001
91491485|NCT00289991|182855474|SUPERIORITY_OR_OTHER||difference in proportions: percent|0.3|||||TWO_SIDED|95.0|-6.3|6.9|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||6.9|-6.3|
91491486|NCT00289991|182855475|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon (Mann-Whitney)||Mann-Whitney test used to investigate the null hypothesis that the times to discontinuation of study medication in each treatment group come from the same distribution.||||0.0026
91491487|NCT00289991|182855476|SUPERIORITY_OR_OTHER||difference in proportions: percent|-4.8||||0.2487|TWO_SIDED|95.0|-13.0|3.4|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent % confidence interval for the difference in proportions.|Day 365; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||3.4|-13.0|0.2487
91729454|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|2.051|||<|0.001|TWO_SIDED|95.0|1.86|2.24||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 14. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.24|1.86|<0.001
91491488|NCT00289991|182855478|SUPERIORITY_OR_OTHER||difference in proportions: percent|-8.8||||0.057|TWO_SIDED|95.0|-17.8|0.3|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||0.3|-17.8|0.0570
91491489|NCT01172522|182855504|SUPERIORITY_OR_OTHER||Other|0.0|||=|1|TWO_SIDED||||||Chi-squared||P values above 0.05 is considered statistically insignificant in this study.|||||=1
91729455|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.987|||<|0.001|TWO_SIDED|95.0|1.79|2.19||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 16. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.19|1.79|<0.001
91729456|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.841|||<|0.001|TWO_SIDED|95.0|1.64|2.05||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 18. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.05|1.64|<0.001
91729457|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.824|||<|0.001|TWO_SIDED|95.0|1.61|2.04||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 20. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.04|1.61|<0.001
91697703|NCT03200704|183289905|NON_INFERIORITY|90% power, 2.5% one-sided significance level,5% non-inferiority margin|||||<|0.0001|||||||Regression, Logistic|||"Hypothesis:~H0: QT ≤ QC - 0.05 H1: QT \> QC - 0.05"||||<0.0001
91697704|NCT01680861|183289909|SUPERIORITY_OR_OTHER|||||||0.32|||||||Log Rank|||||||0.32
91729458|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.651|||<|0.001|TWO_SIDED|95.0|1.43|1.87||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 22. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.87|1.43|<0.001
91729459|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.447|||<|0.001|TWO_SIDED|95.0|1.23|1.67||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 24. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.67|1.23|<0.001
91729460|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.561|||<|0.001|TWO_SIDED|95.0|1.34|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 28. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.34|<0.001
91729461|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.587|||<|0.001|TWO_SIDED|95.0|1.37|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 32. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.37|<0.001
91729462|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.46|1.92||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb Change from BL to week 36. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.92|1.46|<0.001
91729463|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.645|||<|0.001|TWO_SIDED|95.0|1.41|1.88||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 40. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.88|1.41|<0.001
91729464|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.699|||<|0.001|TWO_SIDED|95.0|1.45|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 44. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.45|<0.001
91491490|NCT04203498|182855510|SUPERIORITY||Difference in least squares means|-0.73|STANDARD_ERROR_OF_MEAN|0.914|=|0.4263|TWO_SIDED|95.0|-2.54|1.08|||Linear mixed model repeated measures|||Week 9 to 12 (primary outcome statistics)||1.08|-2.54|=0.4263
91697705|NCT01680861|183289910|SUPERIORITY_OR_OTHER|||||||0.99|||||||Log Rank|||||||0.99
91697706|NCT01680861|183289911|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0
91697707|NCT01680861|183289912|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
91697708|NCT01680861|183289913|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
91697709|NCT01680861|183289914|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
91697710|NCT04967885|183289917|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91697711|NCT01011465|183289919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.03||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.03
91491491|NCT02762578|182855558|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Non-inferiority with respect to change from baseline in HbA1c (%) to week 26 for IDegAsp vs. BIAsp 30.~Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
91491492|NCT02762578|182855558|SUPERIORITY|"If non-inferiority was confirmed, the superiority of the IDegAsp group over the BIAsp 30 group was to be investigated.~Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval, which was calculated using the FAS, was below 0%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
91528408|NCT00708305|182932211|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9762||95.0|-0.21|0.2||No adjustment was made for multiple comparisons as the primary comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.||0.20|-0.21|0.9762
91697712|NCT01011465|183289919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.89||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.89
91729465|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.446|||<|0.001|TWO_SIDED|95.0|1.2|1.69||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 48. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.69|1.20|<0.001
91729466|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.641|||<|0.001|TWO_SIDED|95.0|1.39|1.89||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 52. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.89|1.39|<0.001
91729467|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.37|1.91||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 56. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.91|1.37|<0.001
91729468|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.634|||<|0.001|TWO_SIDED|95.0|1.33|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 60. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.33|<0.001
91697713|NCT01011465|183289919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.52||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.52
91729469|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.404|||<|0.001|TWO_SIDED|95.0|1.08|1.73||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 64. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.73|1.08|<0.001
91729470|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.499|||<|0.001|TWO_SIDED|95.0|1.18|1.82||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 68. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.18|<0.001
91697714|NCT01011465|183289920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.43||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.43
91697715|NCT01011465|183289920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.08||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.08
91697716|NCT01011465|183289920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.25||95.0|||||ANOVA|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.25
91729471|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.438|||<|0.001|TWO_SIDED|95.0|1.1|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 72. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.10|<0.001
91759008|NCT04929249|183411230|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the one-sided 98.75% confidence interval did not exceed the non-inferiority margin of 15%.|Difference in percentage|-10.6|||||TWO_SIDED|97.5|-18.3|-3.0|||Normal approx. to binomial distribution||||Upper limit of one-sided 98.75% CI (-3.0%)|-3.0|-18.3|
91697717|NCT01011465|183289921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.83||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.83
91491493|NCT02762578|182855559|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Superiority with respect to change from baseline in FPG to week 26 for IDegAsp vs. BIAsp 30 (Provided that non-inferiority was confirmed for the primary endpoint)~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero."|Treatment Contrast|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.||-1.10|-1.74|<0.0001
91491494|NCT02762578|182855560|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: Superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in FPG to week 26 was confirmed for IDegAsp vs. BIAsp 30).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.53||||0.0112|TWO_SIDED|95.0|0.33|0.87|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.||0.87|0.33|0.0112
91491495|NCT02762578|182855561|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.57||||0.0002|TWO_SIDED|95.0|0.42|0.77|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate||0.77|0.42|0.0002
91697718|NCT01011465|183289921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.56||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.56
91697719|NCT01011465|183289921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.95||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.95
91697720|NCT00926848|183290040|SUPERIORITY||Mean Difference (Final Values)|4.0|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91697721|NCT00926848|183290041|SUPERIORITY||Mean Difference (Final Values)|6.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91697722|NCT00926848|183290042|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91697723|NCT00926848|183290043|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91697724|NCT00926848|183290044|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91697725|NCT00926848|183290045|SUPERIORITY||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
91697726|NCT01551264|183290046|OTHER|P-value by chi-square comparing the Kaplan-Meier recurrence-free survival probability at 1.2 years post treatment with robust estimate of standard error due to the a priori assumption that data from bilateral limbs are correlated.||||||0.03|||||||Chi-squared|||||||0.03
91697727|NCT03482453|183290061|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.881|||||TWO_SIDED|90.0|0.7108|1.0921||||||||1.0921|0.7108|
91697728|NCT03482453|183290061|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9637|||||TWO_SIDED|90.0|0.8361|1.1107||||||||1.1107|0.8361|
91697729|NCT03482453|183290062|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9317|||||TWO_SIDED|90.0|0.8458|1.0263||||||||1.0263|0.8458|
91697730|NCT03482453|183290067|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|1.0153|||||TWO_SIDED|90.0|0.8977|1.1483||||||||1.1483|0.8977|
91697731|NCT03482453|183290067|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9506|||||TWO_SIDED|90.0|0.874|1.0339||||||||1.0339|0.8740|
91697732|NCT03482453|183290068|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.8861|1.0408||||||||1.0408|0.8861|
91491496|NCT02762578|182855562|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: Superiority with respect to change from baseline in body weight for IDegAsp vs. BIAsp 30 (provided that Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero"|Treatment contrast|0.61||||0.0092|TWO_SIDED|95.0|0.15|1.08|||ANCOVA|Two-sided p-value for testing difference||The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.||1.08|0.15|0.0092
91491497|NCT02762578|182855563|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 6: Superiority with respect to subjects achieving HbA1c \< 7% at end of trial without confirmed hypoglycaemia for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in body weight was confirmed).~Superiority was considered confirmed if the 95% CI for the odds ratio (IDegAsp group/BIAsp 30 group) was entirely above one."|Treatment Ratio|2.22||||0.0002|TWO_SIDED|95.0|1.47|3.35||Two-sided p-value for testing difference|Regression, Logistic|||The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.||3.35|1.47|0.0002
91491498|NCT01090492|182855606|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11||||0.6513|TWO_SIDED|80.0|-0.21|0.44|||ANCOVA|||PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.44|-0.21|0.6513
91491499|NCT01090492|182855606|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.69||||0.0057|TWO_SIDED|80.0|-0.99|-0.38|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.38|-0.99|0.0057
91491500|NCT01090492|182855606|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.1157|TWO_SIDED|80.0|-0.8|-0.08|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.08|-0.80|0.1157
91491501|NCT01090492|182855606|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6286|TWO_SIDED|80.0|-0.56|0.25|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.25|-0.56|0.6286
91491502|NCT01090492|182855607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12||||0.9504|TWO_SIDED|80.0|-2.43|2.68|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||2.68|-2.43|0.9504
91491503|NCT01090492|182855607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35||||0.4651|TWO_SIDED|80.0|-3.74|1.03|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.03|-3.74|0.4651
91491504|NCT01090492|182855607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.59||||0.7423|TWO_SIDED|80.0|-2.92|1.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.73|-2.92|0.7423
91491505|NCT01090492|182855607|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.91||||0.3524|TWO_SIDED|80.0|-4.55|0.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.73|-4.55|0.3524
91491506|NCT01090492|182855608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.21||||0.79|TWO_SIDED|80.0|-4.61|7.03|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||7.03|-4.61|0.7900
91491507|NCT01090492|182855608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.17||||0.1463|TWO_SIDED|80.0|-11.61|-0.73|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.73|-11.61|0.1463
91491508|NCT01090492|182855608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.37||||0.1446|TWO_SIDED|80.0|-4.44|-0.29|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.29|-4.44|0.1446
91491509|NCT01090492|182855608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.09||||0.5497|TWO_SIDED|80.0|-3.45|1.26|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.26|-3.45|0.5497
91491510|NCT01090492|182855609|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.15||||0.5909|TWO_SIDED|80.0|-0.21|0.52|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.52|-0.21|0.5909
91759009|NCT04929249|183411231|SUPERIORITY||LS mean difference|-47.6|||<|0.001|TWO_SIDED|95.0|-52.8|-42.3|||Mixed Models Analysis|||||-42.3|-52.8|<0.001
91759010|NCT04929249|183411232|SUPERIORITY||LS mean difference|-54.4|||<|0.001|TWO_SIDED|95.0|-59.0|-49.8|||Regression, Linear|||||-49.8|-59.0|<0.001
91759011|NCT04929249|183411233|SUPERIORITY||LS mean difference|-48.9|||<|0.001|TWO_SIDED|95.0|-52.9|-44.9|||Regression, Linear|||||-44.9|-52.9|<0.001
91759012|NCT04929249|183411234|SUPERIORITY||Odds Ratio (OR)|42.32|||<|0.001|TWO_SIDED|95.0|22.07|81.16|||Regression, Logistic|||||81.16|22.07|<0.001
91759013|NCT04929249|183411235|SUPERIORITY||Odds Ratio (OR)|17.32|||<|0.001|TWO_SIDED|95.0|6.72|44.66|||Regression, Logistic|||||44.66|6.72|<0.001
91759014|NCT04929249|183411236|SUPERIORITY||Odds Ratio (OR)|24.46|||<|0.001|TWO_SIDED|95.0|14.18|42.19|||Regression, Logistic|||||42.19|14.18|<0.001
91697733|NCT04740827|183290100|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.426|<|0.0001|TWO_SIDED|95.0|-3.27|-1.59|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.59|-3.27|<0.0001
91697734|NCT04740827|183290101|SUPERIORITY||Least Squares Mean Difference|-2.35|STANDARD_ERROR_OF_MEAN|0.425|<|0.0001|TWO_SIDED|95.0|-3.19|-1.52|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.52|-3.19|<0.0001
91697735|NCT04740827|183290102|SUPERIORITY||Odds Ratio (OR)|5.15|||<|0.0001|TWO_SIDED|95.0|3.02|8.79|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.79|3.02|<0.0001
91697736|NCT04740827|183290103|SUPERIORITY||Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|95.0|2.85|8.14|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.14|2.85|<0.0001
91697737|NCT04740827|183290104|SUPERIORITY||Least Squares Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.42|-3.15|<0.0001
91759015|NCT04929249|183411237|SUPERIORITY||Odds Ratio (OR)|35.12|||<|0.001|TWO_SIDED|95.0|19.51|63.24|||Regression, Logistic|||||63.24|19.51|<0.001
91697738|NCT04740827|183290105|SUPERIORITY||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-3.05|-1.32|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.32|-3.05|<0.0001
91759016|NCT04929249|183411238|SUPERIORITY||LS mean difference|-30.1|||<|0.001|TWO_SIDED|95.0|-33.8|-26.3|||Mixed Models Analysis|||Total Cholesterol||-26.3|-33.8|<0.001
91759017|NCT04929249|183411238|SUPERIORITY||LS mean difference|6.6|||<|0.001|TWO_SIDED|95.0|3.6|9.5|||Mixed Models Analysis|||HDL Cholesterol||9.5|3.6|<0.001
91759018|NCT04929249|183411238|SUPERIORITY||LS mean difference|-44.2|||<|0.001|TWO_SIDED|95.0|-49.1|-39.3|||Mixed Models Analysis|||Non-HDL Cholesterol||-39.3|-49.1|<0.001
91759019|NCT04929249|183411238|SUPERIORITY||LS mean difference|-16.9|||<|0.001|TWO_SIDED|95.0|-23.8|-10.0|||Mixed Models Analysis|||VLDL Cholesterol||-10.0|-23.8|<0.001
91759020|NCT04929249|183411238|SUPERIORITY||LS mean difference|-17.8|||<|0.001|TWO_SIDED|95.0|-24.7|-10.9|||Mixed Models Analysis|||Triglycerides||-10.9|-24.7|<0.001
91759021|NCT04929249|183411238|SUPERIORITY||LS mean difference|-42.6|||<|0.001|TWO_SIDED|95.0|-47.5|-37.8|||Mixed Models Analysis|||Apolipoprotein B||-37.8|-47.5|<0.001
91759022|NCT04929249|183411238|SUPERIORITY||LS mean difference|-21.9|||<|0.001|TWO_SIDED|95.0|-25.8|-18.0|||Mixed Models Analysis|||Lipoprotein(a)||-18.0|-25.8|<0.001
91759023|NCT04929249|183411239|SUPERIORITY||LS mean difference|-49.9|||<|0.001|TWO_SIDED|95.0|-56.0|-43.9|||Mixed Models Analysis|||Total Cholesterol||-43.9|-56.0|<0.001
91759024|NCT04929249|183411239|SUPERIORITY||LS mean difference|3.1|||<|0.001|TWO_SIDED|95.0|1.8|4.4|||Mixed Models Analysis|||HDL Cholesterol||4.4|1.8|<0.001
91759025|NCT04929249|183411239|SUPERIORITY||LS mean difference|-52.4|||<|0.001|TWO_SIDED|95.0|-58.1|-46.7|||Mixed Models Analysis|||Non-HDL Cholesterol||-46.7|-58.1|<0.001
91759026|NCT04929249|183411239|SUPERIORITY||LS mean difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.5|-2.8|||Mixed Models Analysis|||VLDL Cholesterol||-2.8|-6.5|<0.001
91759027|NCT04929249|183411239|SUPERIORITY||LS mean difference|-25.3|||<|0.001|TWO_SIDED|95.0|-34.8|-15.8|||Mixed Models Analysis|||Triglycerides||-15.8|-34.8|<0.001
91759028|NCT04929249|183411239|SUPERIORITY||LS mean difference|-36.3|||<|0.001|TWO_SIDED|95.0|-39.7|-32.9|||Mixed Models Analysis|||Apolipoprotein B||-32.9|-39.7|<0.001
91759029|NCT04929249|183411239|SUPERIORITY||LS mean difference|-8.7|||<|0.001|TWO_SIDED|95.0|-10.7|-6.8|||Mixed Models Analysis|||Lipoprotein(a)||-6.8|-10.7|<0.001
91759030|NCT04929249|183411240|SUPERIORITY||Odds Ratio (OR)|1.06||||0.899|TWO_SIDED|95.0|0.43|2.61|||proportional odds model|||||2.61|0.43|0.899
91759031|NCT04929249|183411241|SUPERIORITY||LS mean difference|-0.008||||0.727|TWO_SIDED|95.0|-0.055|0.039|||Regression, Linear|||||0.039|-0.055|0.727
91759032|NCT01009086|183411251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759033|NCT01009086|183411251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759034|NCT01009086|183411251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759035|NCT01009086|183411252|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759036|NCT01009086|183411252|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759037|NCT01009086|183411252|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759038|NCT01009086|183411253|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759039|NCT01009086|183411253|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759040|NCT01009086|183411253|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759041|NCT01009086|183411254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759042|NCT01009086|183411254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759043|NCT01009086|183411254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759044|NCT01009086|183411255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759045|NCT01009086|183411255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759046|NCT01009086|183411255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91759047|NCT01009086|183411256|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
91759048|NCT01009086|183411256|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91491511|NCT01090492|182855609|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.0053|TWO_SIDED|80.0|-1.12|-0.43|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.43|-1.12|0.0053
91491512|NCT01090492|182855609|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.3462|TWO_SIDED|80.0|-0.67|0.1|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.10|-0.67|0.3462
91491513|NCT01090492|182855609|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.194|TWO_SIDED|80.0|-0.88|-0.01|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.01|-0.88|0.1940
91491514|NCT00457301|182855675|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.05||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.05
91491515|NCT00457301|182855676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||95.0|||||ANCOVA|||ANCOVA adjuusting for baseline HADS anxiety scores||||0.34
91491516|NCT00457301|182855676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANCOVA|||ANCOVA adjusting for baseline HADS depression scores.||||0.55
91528409|NCT00708305|182932212|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.49|||<|0.0001|TWO_SIDED|95.0|0.28|0.7||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
91729472|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.185|||<|0.001|TWO_SIDED|95.0|0.83|1.54||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 76. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.54|0.83|<0.001
91729473|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.443|||<|0.001|TWO_SIDED|95.0|1.11|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 80. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.11|<0.001
91729474|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.374|||<|0.001|TWO_SIDED|95.0|0.99|1.75||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 84. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.75|0.99|<0.001
91491517|NCT00457301|182855677|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|||||ANCOVA|||||||0.001
91491518|NCT00457301|182855678|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.46||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.46
91491519|NCT03583697|182855693|SUPERIORITY||Least Square Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.02|0.53||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in least squares (LS) means were obtained from an analysis of covariance model."||0.53|-0.02|
91528410|NCT00708305|182932212|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001||95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
91729475|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.171|||<|0.001|TWO_SIDED|95.0|0.79|1.55||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 88. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.55|0.79|<0.001
91729476|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.382|||<|0.001|TWO_SIDED|95.0|0.98|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 92. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|0.98|<0.001
91729477|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.563|||<|0.001|TWO_SIDED|95.0|1.15|1.97||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 96. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.97|1.15|<0.001
91759049|NCT01009086|183411256|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
91729478|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.448|||<|0.001|TWO_SIDED|95.0|1.06|1.83||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 100. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.83|1.06|<0.001
91491520|NCT03583697|182855693|SUPERIORITY||Least Square Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|0.07|0.54||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in LS means were obtained from an analysis of covariance model."||0.54|0.07|
91491521|NCT03583697|182855694|SUPERIORITY||Least Square Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|-0.02|1.56||||||Difference in LS means were obtained from an analysis of covariance model.||1.56|-0.02|
91491522|NCT03583697|182855694|SUPERIORITY||Least Square Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.26|1.66||||||Difference in LS means were obtained from an analysis of covariance model.||1.66|0.26|
91491523|NCT03583697|182855695|SUPERIORITY||Least Square Mean Difference (Net)|0.78|||||TWO_SIDED|95.0|0.02|1.54||||||||1.54|0.02|
91491524|NCT03583697|182855695|SUPERIORITY||Least Square Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.24|1.59||||||Difference in LS means were obtained from an analysis of covariance model.||1.59|0.24|
91528411|NCT00708305|182932212|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001||95.0|0.28|0.7||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
91528412|NCT00708305|182932212|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001|TWO_SIDED|95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
91729479|NCT01887600|183354674|SUPERIORITY||Least squares mean difference|1.347|||<|0.001|TWO_SIDED|95.0|0.9|1.79||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 104. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.79|0.90|<0.001
91729480|NCT01887600|183354675|SUPERIORITY||Least squares mean difference|1.614|||<|0.001|TWO_SIDED|95.0|1.42|1.81||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 28-36. A Mixed Model of Repeated Measures was applied using the visits up to week 36. The results were based on the estimated difference between the two treatment arms overall mean effect during week 28 to 36 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.42|<0.001
91491525|NCT03583697|182855696|SUPERIORITY||Least Square Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.17|0.04||||||Difference in LS means were obtained from an analysis of covariance model.||0.04|-0.17|
91729481|NCT01887600|183354676|SUPERIORITY||Least squares mean difference|1.594|||<|0.001|TWO_SIDED|95.0|1.38|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 44-52. A Mixed Model of Repeated Measures was applied using the visits up to week 52. The results were based on the estimated difference between the two treatment arms overall mean effect during week 44 to 52 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.38|<0.001
91729482|NCT01887600|183354677|SUPERIORITY||Least squares mean difference|1.452|||<|0.001|TWO_SIDED|95.0|1.1|1.8||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from BL to average Hb weeks 96-104. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms overall mean effect during week 96 to 104 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.80|1.10|<0.001
91729483|NCT01887600|183354681|SUPERIORITY||Hazard Ratio (HR)|0.945|||=|0.643|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.20|0.74|=0.643
91759050|NCT01192828|183411257|OTHER|Descriptive analysis||||||0.235|||||||t-test, 2 sided|paired||Null hypothesis applied.||||0.235
91759051|NCT01192828|183411258|OTHER|Descriptive analysis.||||||0.701|||||||t-test, 2 sided|paired||Null hypothesis assumed.||||0.701
91759052|NCT01192828|183411259|OTHER|Descriptive analysis.||||||0.19|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.190
91759053|NCT01192828|183411260|OTHER|Descriptive analysis.||||||0.052|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.052
91759054|NCT01192828|183411261|OTHER|Descriptive analysis.||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed.||||0.014
91759055|NCT01192828|183411263|OTHER|Descriptive analysis||||||0.541|||||||Spearman's rank correlation|||Null hypothesis assumed|Spearman's rank correlation rho is 0.179, with p value 0.541, N is 14|||.541
91491526|NCT03583697|182855696|SUPERIORITY||Least Square Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.15|0.03||||||Difference in LS means were obtained from an analysis of covariance model.||0.03|-0.15|
91491527|NCT00365508|182855747|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||a priori threshold for statistical significance|Chi-squared|||Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.||||.05
91729484|NCT01887600|183354683|SUPERIORITY||Hazard Ratio (HR)|0.139|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Regression, Cox|||Time to start rescue therapy within first 24 weeks. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.23|0.08|<0.001
91729485|NCT01887600|183354684|SUPERIORITY||Cox Proportional Hazard|0.343|||<|0.001|TWO_SIDED|95.0|0.21|0.55|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.55|0.21|<0.001
91729486|NCT01887600|183354685|SUPERIORITY||Least squares mean difference|-0.045|||=|0.128|TWO_SIDED|95.0|-0.1|0.01|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied including treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates.||0.01|-0.10|=0.128
91491528|NCT00679432|182855759|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.1393|TWO_SIDED|95.0|-1.8|13.4|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.||13.4|-1.8|0.1393
91491529|NCT00679432|182855759|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|10.4||||0.0143|TWO_SIDED|95.0|2.2|18.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||18.7|2.2|0.0143
91491530|NCT00679432|182855759|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.7||||0.22|TWO_SIDED|95.0|-2.7|12.1|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.1|-2.7|0.2200
91729487|NCT01887600|183354686|SUPERIORITY||Least squares mean difference|-10.429|||=|0.183|TWO_SIDED|95.0|-25.81|4.95|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied included treatment arm, region, CV history as categorical variables and baseline Hb and baseline eGFR as continuous variables.||4.95|-25.81|=0.183
91729488|NCT01887600|183354687|SUPERIORITY||Hazard Ratio (HR)|0.101|||<|0.001|TWO_SIDED|95.0|0.06|0.17|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.17|0.06|<0.001
91729489|NCT01887600|183354688|SUPERIORITY||Hazard Ratio (HR)|0.538|||=|0.045|TWO_SIDED|95.0|0.29|0.99|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.99|0.29|=0.045
91729490|NCT01887600|183354697|SUPERIORITY||Least squares mean difference|0.374|||=|0.475|TWO_SIDED|95.0|-0.65|1.4||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||The Mixed Model of Repeated Measures included treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline eGFR as continuous covariates.||1.40|-0.65|=0.475
91729491|NCT01887600|183354698|SUPERIORITY||Least squares mean difference|1.704|||=|0.047|TWO_SIDED|95.0|0.02|3.38||LSM difference p-value is for test of differences|Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The model includes treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, baseline eGFR as continuous covariates. Baseline FACT-An Ans is defined as the FACT-An Ans value on day 1.||3.38|0.02|=0.047
91729492|NCT01887600|183354699|SUPERIORITY||Least squares mean difference|2.086|||=|0.225|TWO_SIDED|95.0|-1.29|5.46|||Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms overall mean effect during week 12 to 28 period based on this MMRM model.The model includes treatment, visit (week8, week12 and week28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Total Score, baseline Hb, baseline eGFR as continuous covariates.||5.46|-1.29|=0.225
91729493|NCT01887600|183354710|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.973|TWO_SIDED|95.0|0.75|1.32|||Regression, Cox|||Time to doubling of serum Creatinine. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.32|0.75|=0.973
91729494|NCT01887600|183354711|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.972|TWO_SIDED|95.0|0.76|1.3|||Regression, Cox|||Time to CKD progression. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.30|0.76|=0.972
91729495|NCT01887600|183354712|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.439|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.16|0.70|=0.439
91729496|NCT03688139|183354713|SUPERIORITY||difference in slopes|0.23||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
91729497|NCT03688139|183354713|OTHER|This analysis tested whether the course of LPP was associated with the course of BADS over the 9-week treatment period in the Engage group.|Slope|0.03||||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||.14
91729498|NCT03688139|183354714|SUPERIORITY||difference in slopes|-0.06||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
91729499|NCT03688139|183354715|SUPERIORITY||difference in slopes|-0.03||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
91729500|NCT03688139|183354716|SUPERIORITY||difference in slopes|-0.45||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||.39
91729501|NCT03688139|183354717|OTHER|This analysis tested the hypothesis that change in LPP for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|-0.1||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||.58
91491531|NCT00679432|182855760|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.3146|TWO_SIDED|95.0|-5.5|17.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||17.0|-5.5|0.3146
91491532|NCT00679432|182855760|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.142|TWO_SIDED|95.0|-2.8|19.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||19.9|-2.8|0.1420
91491533|NCT00679432|182855760|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|9.1||||0.1189|TWO_SIDED|95.0|-2.3|20.4|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||20.4|-2.3|0.1189
91528413|NCT00708305|182932212|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.95|||<|0.0001|TWO_SIDED|95.0|0.74|1.16||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.16|0.74|<0.0001
91697739|NCT04740827|183290106|SUPERIORITY||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.43|-1.93|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.93|-3.43|<0.0001
91528414|NCT00708305|182932213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.83||||0.0151|TWO_SIDED|95.0|0.12|1.72||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.72|0.12|0.0151
91528415|NCT00708305|182932213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.36|||<|0.0001|TWO_SIDED|95.0|0.69|2.36||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.36|0.69|<0.0001
91697740|NCT04740827|183290107|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-3.36|-1.86|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.86|-3.36|<0.0001
91697741|NCT04740827|183290108|SUPERIORITY||Least Squares Mean Difference|17.67|STANDARD_ERROR_OF_MEAN|2.348|<|0.0001|TWO_SIDED|95.0|13.05|22.3|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.30|13.05|<0.0001
91729502|NCT03688139|183354717|OTHER|This analysis tested the hypothesis that change in SHAPS for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|0.0||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||.96
91729503|NCT00498485|183354724|SUPERIORITY_OR_OTHER||||||<|0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.||||<0.04
91729504|NCT00452400|183354735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.027||0.0233||95.0|0.008|0.113|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.113|0.008|0.0233
91729505|NCT00452400|183354735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.027||0.0003||95.0|0.044|0.149|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.149|0.044|0.0003
91729506|NCT00452400|183354735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.072|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.072|<0.0001
91729507|NCT00452400|183354735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.08|0.185|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.185|0.080|<0.0001
91729508|NCT00452400|183354736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0004||95.0|0.039|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|0.039|0.0004
91729509|NCT00452400|183354736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.088|0.186|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.186|0.088|<0.0001
91729510|NCT00452400|183354736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.176|0.080|<0.0001
91729511|NCT00452400|183354736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.218|0.120|<0.0001
91491534|NCT00679432|182855761|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|0.0||||0.9991|TWO_SIDED|95.0|-11.8|11.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.||11.8|-11.8|0.9991
91491535|NCT00824720|182855762|SUPERIORITY_OR_OTHER||least square mean difference|-0.22|STANDARD_DEVIATION|2.3||0.9737|||||||ANCOVA||Mean difference was calculated as high dose minus placebo.|The alternative hypothesis was that the high dose was different from the placebo.||||0.9737
91528416|NCT00708305|182932213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.01|||<|0.0001|TWO_SIDED|95.0|2.06|4.05||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments. Tests were 2-sided.||4.05|2.06|<0.0001
91729512|NCT00452400|183354737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.026||0.0011||95.0|0.034|0.136|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.136|0.034|0.0011
91729513|NCT00452400|183354737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.07|0.173|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.173|0.070|<0.0001
91729514|NCT00452400|183354737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.075|<0.0001
91729515|NCT00452400|183354737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.179|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.179|0.077|<0.0001
91729516|NCT00452400|183354738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0127||95.0|0.024|0.197|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.197|0.024|0.0127
91729517|NCT00452400|183354738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001||95.0|0.087|0.261|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.261|0.087|<0.0001
91491536|NCT00824720|182855762|SUPERIORITY_OR_OTHER||least square mean difference|-1.11|STANDARD_DEVIATION|3.5||0.4711|||||||ANCOVA||The mean difference was calculated as low dose minus placebo.|The alternative hypothesis is that the low dose was different from placebo.||||0.4711
91528417|NCT00708305|182932213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||<|0.0001|TWO_SIDED|95.0|0.41|1.27||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.27|0.41|<0.0001
91491537|NCT01558271|182855779|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|||<|0.001|TWO_SIDED|95.0|-1.79|-1.35|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide greater than 99% power to demonstrate superiority of LY2189265 to placebo. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and placebo being 0.8%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||-1.35|-1.79|<0.001
91729518|NCT00452400|183354738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001||95.0|0.084|0.255|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.255|0.084|0.0001
91729519|NCT00452400|183354738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.084|0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.258|0.084|0.0001
91729520|NCT00452400|183354739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.0836||95.0|-0.012|0.192|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.192|-0.012|0.0836
91729521|NCT00452400|183354739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.052||0.0011||95.0|0.068|0.274|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.274|0.068|0.0011
91729522|NCT00452400|183354739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.051||0.0037||95.0|0.049|0.25|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.250|0.049|0.0037
91759056|NCT01192828|183411265|OTHER|Descriptive analysis||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.014
91759057|NCT01192828|183411266|OTHER|Descriptive analysis||||||0.012|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.012
91759058|NCT01192828|183411267|OTHER|Descriptive analysis.||||||0.16|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.160
91759059|NCT01192828|183411268|OTHER|Descriptive analysis||||||0.1|||||||t-test, 2 sided|||||||0.10
91759060|NCT03037983|183411271|SUPERIORITY||Mean Difference (Net)|1.38||||0.849|TWO_SIDED||||||t-test, 2 sided|||||||.849
91759061|NCT03037983|183411273|SUPERIORITY||Mean Difference (Net)|0.5||||0.782|TWO_SIDED|||||t = 0.287|t-test, 2 sided|||||||.782
91491538|NCT01558271|182855779|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to Liraglutide. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to liraglutide.|LS Mean Difference|-0.1||||0.248|TWO_SIDED|95.0|-0.27|0.07|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide \>90% power to confirm non-inferiority of LY2189265 to liraglutide by a margin of 0.4%. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and Liraglutide being 0%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||0.07|-0.27|0.248
91491539|NCT01558271|182855780|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.04|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||||-0.01|-0.39|0.040
91729523|NCT00452400|183354739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.052||0.0047||95.0|0.046|0.251|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.251|0.046|0.0047
91491540|NCT01558271|182855781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
91491541|NCT01558271|182855781|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.608
91491542|NCT01558271|182855781|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
91491543|NCT01558271|182855781|SUPERIORITY_OR_OTHER|||||||0.844|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.844
91491544|NCT01558271|182855781|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.112
91491545|NCT01558271|182855781|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.103
91697742|NCT04740827|183290109|SUPERIORITY||Least Squares Mean Difference|17.88|STANDARD_ERROR_OF_MEAN|2.308|<|0.0001|TWO_SIDED|95.0|13.34|22.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.42|13.34|<0.0001
91697743|NCT04740827|183290110|SUPERIORITY||Least Squares Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.844|<|0.0001|TWO_SIDED|95.0|-6.37|-3.05|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-3.05|-6.37|<0.0001
91697744|NCT04740827|183290111|SUPERIORITY||Least Squares Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|0.786|<|0.0001|TWO_SIDED|95.0|-5.94|-2.85|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-2.85|-5.94|<0.0001
91697745|NCT04740827|183290112|SUPERIORITY||Least Squares Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.912|<|0.0001|TWO_SIDED|95.0|-8.22|-4.63|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-4.63|-8.22|<0.0001
91729524|NCT00452400|183354740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.051||0.0695||95.0|-0.008|0.195|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.195|-0.008|0.0695
91491546|NCT01558271|182855782|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.21|||<|0.001|TWO_SIDED|95.0|-47.31|-33.11||Treatment comparison for FBG at 26 weeks between LY2189265 and placebo.|Mixed Models Analysis|||||-33.11|-47.31|<0.001
91697746|NCT00784550|183290120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91697747|NCT00784550|183290121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91697748|NCT00784550|183290122|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
91697749|NCT00784550|183290123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91697750|NCT00784550|183290124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91697751|NCT00784550|183290125|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Mastery domain|ANCOVA|||||||0.069
91729525|NCT00452400|183354740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.052||0.0018||95.0|0.061|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.264|0.061|0.0018
91729526|NCT00452400|183354740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.051||0.0008||95.0|0.072|0.272|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.272|0.072|0.0008
91697752|NCT00784550|183290125|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||Fatigue domain|ANCOVA|||||||0.470
91697753|NCT00784550|183290125|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||Emotional function domain|ANCOVA|||||||0.394
91491547|NCT01558271|182855782|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.835|TWO_SIDED|95.0|-4.82|5.96|||Mixed Models Analysis|Treatment comparison for FBG at 26 weeks between LY2189265 and Liraglutide.||||5.96|-4.82|0.835
91491548|NCT01558271|182855782|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77||||0.553|TWO_SIDED|95.0|-7.65|4.1||Treatment comparison for FBG at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||4.10|-7.65|0.553
91491549|NCT01558271|182855784|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.057|TWO_SIDED|95.0|-0.02|1.23|||Mixed Models Analysis|Treatment comparison for body weight at 26 weeks between LY2189265 and placebo.||||1.23|-0.02|0.057
91491550|NCT01558271|182855784|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.168|TWO_SIDED|95.0|-0.14|0.82||Treatment comparison for body weight at 26 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.82|-0.14|0.168
91697754|NCT00784550|183290125|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||ANCOVA|Dyspnea domain||||||0.879
91697755|NCT02715700|183290126|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.9|1.01||||||||1.01|0.90|
91697756|NCT02715700|183290127|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
91697757|NCT02715700|183290128|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||||1.03|0.93|
91697758|NCT02715700|183290130|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.9|1.06||||||||1.06|0.90|
91697759|NCT02715700|183290131|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.86|1.1||||||||1.10|0.86|
91697760|NCT02715700|183290132|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
91697761|NCT02715700|183290134|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.9|1.03||||||||1.03|0.90|
91697762|NCT02715700|183290135|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.87|1.05||||||||1.05|0.87|
91697763|NCT02715700|183290136|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.92|1.03||||||||1.03|0.92|
91697764|NCT04166591|183290161|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||binomial test|||||||<0.01
91697765|NCT04166591|183290161|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
91697766|NCT04166591|183290161|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
91697767|NCT04166591|183290161|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
91697768|NCT04166591|183290162|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
91697769|NCT04166591|183290162|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.||||||0.12|||||||Binomial test|||||||0.12
91697770|NCT04166591|183290162|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
91697771|NCT04166591|183290162|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
91697772|NCT03535194|183290167|SUPERIORITY||Risk Difference (RD)|73.5|||<|0.001|TWO_SIDED|95.0|68.2|78.7|||Cochran-Mantel-Haenszel|||||78.7|68.2|<0.001
91729527|NCT00452400|183354740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.052||0.0006||95.0|0.077|0.281|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.281|0.077|0.0006
91729528|NCT00452400|183354741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.078|0.204|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.204|0.078|<0.0001
91729529|NCT00452400|183354741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.099|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.225|0.099|<0.0001
91491551|NCT01558271|182855784|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.911|TWO_SIDED|95.0|-0.64|0.57||Treatment comparison for body weight at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.57|-0.64|0.911
91491552|NCT01558271|182855785|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86||||0.723|TWO_SIDED|95.0|-12.2|8.48||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||8.48|-12.20|0.723
91491553|NCT01558271|182855785|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.998|TWO_SIDED|95.0|-7.92|7.91||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||7.91|-7.92|0.998
91697773|NCT03535194|183290168|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|62.7|73.3|||Cochran-Mantel-Haenszel|||||73.3|62.7|<0.001
91729530|NCT00452400|183354741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.151|0.275|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.275|0.151|<0.0001
91729531|NCT00452400|183354741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.151|0.277|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.277|0.151|<0.0001
91729532|NCT00452400|183354742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.097|0.231|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.231|0.097|<0.0001
91729533|NCT00452400|183354742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.102|0.237|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.237|0.102|<0.0001
91729534|NCT00452400|183354742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.152|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.152|<0.0001
91729535|NCT00452400|183354742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.157|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.292|0.157|<0.0001
91729536|NCT00452400|183354743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.15|0.373|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.373|0.150|<0.0001
91729537|NCT00452400|183354743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.171|0.395|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.395|0.171|<0.0001
91697774|NCT03535194|183290169|SUPERIORITY||Risk Difference (RD)|81.6|||<|0.001|TWO_SIDED|95.0|76.1|87.0|||Cochran-Mantel-Haenszel|||||87.0|76.1|<0.001
91697775|NCT03535194|183290170|SUPERIORITY||Risk Difference (RD)|51.7|||<|0.001|TWO_SIDED|95.0|47.6|55.8|||Cochran-Mantel-Haenszel|||||55.8|47.6|<0.001
91697776|NCT03535194|183290171|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|19.3|27.1|||Cochran-Mantel-Haenszel|||||27.1|19.3|<0.001
91697777|NCT03535194|183290172|SUPERIORITY||Risk Difference (RD)|53.5|||<|0.001|TWO_SIDED|95.0|47.7|59.3|||Cochran-Mantel-Haenszel|||||59.3|47.7|<0.001
91729538|NCT00452400|183354743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.201|0.421|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.421|0.201|<0.0001
91729539|NCT00452400|183354743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.192|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.416|0.192|<0.0001
91729540|NCT00452400|183354744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.167|0.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.409|0.167|<0.0001
91729541|NCT00452400|183354744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.159|0.401|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.401|0.159|<0.0001
91729542|NCT00452400|183354744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.178|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.416|0.178|<0.0001
91729543|NCT00452400|183354744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.164|0.407|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.407|0.164|<0.0001
91491554|NCT01558271|182855785|SUPERIORITY_OR_OTHER||LS Mean Difference|0.83||||0.848|TWO_SIDED|95.0|-7.72|9.38||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||9.38|-7.72|0.848
91697778|NCT03535194|183290173|SUPERIORITY||LSMean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|-7.01|-2.88|||Mixed Models Analysis|||||-2.88|-7.01|<0.001
91729544|NCT00452400|183354745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.09|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.176|0.090|<0.0001
91491555|NCT01558271|182855785|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.03||||0.357|TWO_SIDED|95.0|-9.48|3.42||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||3.42|-9.48|0.357
91491556|NCT01558271|182855785|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.49||||0.533|TWO_SIDED|95.0|-10.35|5.36||Treatment comparison for HOMA2-%S based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.36|-10.35|0.533
91697779|NCT03535194|183290174|SUPERIORITY||LSMean Difference|-15.15|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|95.0|-16.51|-13.8|||Mixed Models Analysis|||||-13.80|-16.51|<0.001
91491557|NCT01558271|182855785|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.747|TWO_SIDED|95.0|-7.32|5.25||Treatment comparison for HOMA2-%S based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.25|-7.32|0.747
91491558|NCT01558271|182855786|SUPERIORITY_OR_OTHER||LS Mean Difference|28.35|||<|0.001|TWO_SIDED|95.0|21.63|35.07||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||35.07|21.63|<0.001
91491559|NCT01558271|182855786|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.242|TWO_SIDED|95.0|-2.09|8.24||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||8.24|-2.09|0.242
91491560|NCT01558271|182855786|SUPERIORITY_OR_OTHER||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|19.25|30.4||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||30.40|19.25|<0.001
91697780|NCT03535194|183290175|SUPERIORITY||LSMean Difference|-9.59|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-12.63|-6.55|||Mixed Models Analysis|||||-6.55|-12.63|<0.001
91697781|NCT03535194|183290176|SUPERIORITY||LSMean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.642|<|0.001|TWO_SIDED|95.0|2.2|4.72|||ANCOVA|||||4.72|2.20|<0.001
91697782|NCT03535194|183290177|SUPERIORITY||LSMean Difference|3.96|STANDARD_ERROR_OF_MEAN|0.711|<|0.001|TWO_SIDED|95.0|2.56|5.35|||ANCOVA|||||5.35|2.56|<0.001
91697783|NCT03535194|183290178|SUPERIORITY||Risk Difference (RD)|65.0|||<|0.001|TWO_SIDED|95.0|59.3|70.8|||Cochran-Mantel-Haenszel|||||70.8|59.3|<0.001
91697784|NCT03535194|183290180|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.255||0.826|TWO_SIDED|95.0|-4.96|3.96|||ANCOVA|||||3.96|-4.96|0.826
91697785|NCT03535194|183290182|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|3.3|||<|0.0001|TWO_SIDED|95.0|-1.4|7.9|||Cochran-Mantel-Haenszel|||||7.9|-1.4|<0.0001
91697786|NCT03535194|183290183|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|1.6|||<|0.0001|TWO_SIDED|95.0|-3.4|6.6|||Cochran-Mantel-Haenszel|||||6.6|-3.4|<0.0001
91697787|NCT01665157|183290205|SUPERIORITY_OR_OTHER|||||||0.435||||||Not significant|ANOVA|||||||0.435
91697788|NCT01665157|183290206|SUPERIORITY_OR_OTHER|||||||0.046|||||||Chi-squared|||||||0.046
91697789|NCT01665157|183290206|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||"Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality."||||0.024
91697790|NCT01665157|183290206|SUPERIORITY_OR_OTHER|||||||0.041|||||||Chi-squared|||||||0.041
91697791|NCT01665157|183290209|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
91697792|NCT01665157|183290210|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
91697793|NCT01665157|183290211|SUPERIORITY_OR_OTHER|||||||0.025|||||||Chi-squared|||||||0.025
91697794|NCT04304235|183290215|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|||||||||||||
91697795|NCT02217410|183290229|OTHER||Mean Difference (Final Values)|0.095||||0.8976|TWO_SIDED|95.0|-0.067|0.263|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 3|||0.263|-0.067|0.8976
91697796|NCT02217410|183290229|OTHER||Mean Difference (Final Values)|0.093||||0.8836|TWO_SIDED|95.0|-0.084|0.271|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 6|||0.271|-0.084|0.8836
91697797|NCT02217410|183290229|OTHER||Mean Difference (Final Values)|0.093||||0.8822|TWO_SIDED|95.0|-0.085|0.272|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 9|||0.272|-0.085|0.8822
91697798|NCT02217410|183290229|OTHER||Mean Difference (Final Values)|0.093||||0.8821|TWO_SIDED|95.0|-0.087|0.273|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 12|||0.273|-0.087|0.8821
91697799|NCT00626821|183290237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.813|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|1.553|2.073|||Mixed Models Analysis|||||2.073|1.553|<0.0001
91697800|NCT01471340|183290239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The projected sample size provided 90% power at a 2.5% alpha level (one-sided) to determine non-inferiority of MF/F and MF. For analysis of the first SAO in participants, MF/F MDI BID was considered non-inferior to MF MDI BID if the upper bound for the 95% confidence interval (CI) of the hazard ratio (HR) of MF/F MDI BID versus MF MDI BID was lower than 2.0 (noninferiority margin).|Hazard Ratio (HR)|1.22||||0.411|TWO_SIDED|95.0|0.76|1.94|||Cox proportional-hazard model||The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAO; pooled MF/F treatments and pooled MF treatments||1.94|0.76|0.411
91697801|NCT01471340|183290240|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.021|TWO_SIDED|95.0|0.8|0.98|||Cox proportional-hazard model|Superiority of MF/F MDI BID vs MF MDI BID was determined if the HR was less than 1 and achieved statistical significance (one-sided p-value \< 0.025).|The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAEX; pooled MF/F treatments and pooled MF treatments||0.98|0.80|0.021
91491561|NCT01558271|182855786|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.376|TWO_SIDED|95.0|-2.32|6.13||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.13|-2.32|0.376
91491562|NCT01558271|182855786|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.417|TWO_SIDED|95.0|-2.72|6.54||Treatment comparison for HOMA2-%B based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.54|-2.72|0.417
91491563|NCT01558271|182855786|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.753|TWO_SIDED|95.0|-3.83|5.29||Treatment comparison for HOMA2-%B based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.29|-3.83|0.753
91528418|NCT00708305|182932213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.74||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.74|1.50|<0.0001
91491564|NCT01558271|182855787|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and placebo.|Fisher Exact|||||||>0.999
91491565|NCT01558271|182855787|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
91491566|NCT01558271|182855787|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 52 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
91697802|NCT05875025|183290243|OTHER||Adjusted mean difference|1.36||||0.442|TWO_SIDED|95.0|-2.28|4.99|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR2 at baseline as a covariate.||||4.99|-2.28|0.442
91697803|NCT05875025|183290244|OTHER||Adjusted mean difference|0.7||||0.553|TWO_SIDED|95.0|-1.73|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR4 at baseline as a covariate.||||3.12|-1.73|0.553
91697804|NCT01098500|183290246|SUPERIORITY_OR_OTHER||Prevalence percentage|2.2|||||TWO_SIDED|95.0|0.9|3.5|||||Prevalence percentage is the number of patients with an ALT \>=3 times ULN divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||3.5|0.9|
91697805|NCT01098500|183290247|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|6.2|||||TWO_SIDED|95.0|3.3|9.0|||||Incidence rate (IR) is the number of patients with an ALT \>=3 times ULN after initiation of TKI divided by person time contributed by all patients with normal ALT (\<1 times ULN) at baseline. IR expressed per 100 person years.|||9.0|3.3|
91697806|NCT01098500|183290248|SUPERIORITY_OR_OTHER||Prevalence percentage|0.4|||||TWO_SIDED|95.0|0.1|1.4|||||Prevalence percentage is the number of patients with Hy's Law divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||1.4|0.1|
91697807|NCT01098500|183290249|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|0.4|||||TWO_SIDED|95.0|0.0|2.0|||||Incidence rate (IR) is the number of patients with Hy's Law after initiation of TKI divided by person time contributed by all patients with normal ALT, AST, ALP, and BIL (\< 1 times ULN) at baseline. IR is expressed per 100 person years.|||2.0|0.0|
91697808|NCT02218736|183290258|SUPERIORITY|||||||0.0095|||||||t-test, 1 sided|||||||0.0095
91697809|NCT02218736|183290259|SUPERIORITY|||||||0.0345|||||||t-test, 1 sided|||||||0.0345
91697810|NCT02218736|183290260|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.430
91697811|NCT03452488|183290261|SUPERIORITY|||||||0.2437|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic.||||0.2437
91697812|NCT03452488|183290261|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic||||0.2000
91697813|NCT03452488|183290261|SUPERIORITY|||||||0.324|TWO_SIDED|95.0|||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.3240
91697814|NCT03452488|183290261|SUPERIORITY|Gait Speed Based on Adjusted Bayesian Imputation||||||0.5123|||||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.5123
91697815|NCT03452488|183290261|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.6920
91697816|NCT03452488|183290261|SUPERIORITY|||||||0.085|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.0850
91697817|NCT03452488|183290262|SUPERIORITY|||||||0.9408|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9408
91697818|NCT03452488|183290262|SUPERIORITY|||||||0.9485|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9485
91697819|NCT03452488|183290262|SUPERIORITY|||||||0.9848|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.9848
91697820|NCT03452488|183290262|SUPERIORITY|||||||0.5017|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.5017
91697821|NCT03452488|183290263|SUPERIORITY|||||||0.52|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.5200
91491567|NCT02610725|182855798|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|0.81||0.013|TWO_SIDED|95.0|-3.73|-0.46|||t-test, 2 sided|51 degrees of freedom.|Means were analyzed in (pre-post) format. A negative mean here indicates an increase in positive affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.||-0.46|-3.73|0.013
91491568|NCT02610725|182855798|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|4.1|8.02|||t-test, 2 sided|51 degrees of freedom|Means were analyzed in a (pre-post) format. A positive mean indicates a decrease in negative affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.||8.02|4.10|<0.001
91491569|NCT00743483|182855805|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||t-test, 2 sided|||||||0.2179
91513239|NCT04382326|182898000|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.64||||||95.0|1.46|1.83||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.83|1.46|
91513240|NCT04382326|182898008|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.29||||||95.0|1.05|1.58||||||Measles: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.58|1.05|
91697822|NCT03452488|183290263|SUPERIORITY|||||||0.3577|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.3577
91697823|NCT03452488|183290263|SUPERIORITY|||||||0.9237|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.9237
91697824|NCT03452488|183290263|SUPERIORITY|||||||0.7629|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.7629
91697825|NCT03452488|183290263|SUPERIORITY|||||||0.5695|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Change from Baseline in Handgrip Strength Test (left hand)||||0.5695
91697826|NCT03452488|183290263|SUPERIORITY|||||||0.3523|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Left hand)||||0.3523
91697827|NCT03452488|183290263|SUPERIORITY|||||||0.5652|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.5652
91697828|NCT03452488|183290263|SUPERIORITY|||||||0.2472|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.2472
91697829|NCT03452488|183290264|SUPERIORITY|||||||0.9859||||||Statistical Analysis of Change from Baseline in ALM|ANCOVA|||||||0.9859
91697830|NCT03452488|183290264|SUPERIORITY|||||||0.404|||||||ANCOVA|||Statistical Analysis of Change from Baseline in ALM||||0.4040
91729545|NCT00452400|183354745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.128|0.215|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.215|0.128|<0.0001
91729546|NCT00452400|183354745|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.162|0.247|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.247|0.162|<0.0001
91697831|NCT03452488|183290265|SUPERIORITY|||||||0.1219|||||||Regression, Logistic|||||||0.1219
91697832|NCT03452488|183290265|SUPERIORITY|||||||0.052|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0520
91697833|NCT03452488|183290266|SUPERIORITY|||||||0.8917|||||||ANCOVA|||||||0.8917
91697834|NCT03452488|183290266|SUPERIORITY||Mean Difference (Final Values)|-4.999|STANDARD_ERROR_OF_MEAN|10.2172||0.6317|TWO_SIDED|95.0|-26.777|16.778|||ANCOVA|||||16.778|-26.777|0.6317
91697835|NCT03452488|183290267|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
91697836|NCT03452488|183290267|SUPERIORITY|||||||0.0543|||||||Mixed Models Analysis|||||||0.0543
91697837|NCT03452488|183290268|SUPERIORITY|||||||0.8824|||||||ANCOVA|||||||0.8824
91697838|NCT03452488|183290268|SUPERIORITY|||||||0.1578|||||||ANCOVA|||||||0.1578
91697839|NCT03452488|183290269|SUPERIORITY|||||||0.0511|||||||ANCOVA|||||||0.0511
91697840|NCT03452488|183290269|SUPERIORITY|||||||0.2771|||||||ANCOVA|||||||0.2771
91697841|NCT03452488|183290270|SUPERIORITY|||||||0.8084|||||||Mixed Models Analysis|||||||0.8084
91697842|NCT03452488|183290270|SUPERIORITY|||||||0.7266|||||||Mixed Models Analysis|||||||0.7266
91697843|NCT03452488|183290271|SUPERIORITY|||||||0.2312|||||||Mixed Models Analysis|||||||0.2312
91697844|NCT03452488|183290271|SUPERIORITY|||||||0.2701|||||||Mixed Models Analysis|||||||0.2701
91697845|NCT03452488|183290272|SUPERIORITY|||||||0.8934|||||||ANCOVA|||||||0.8934
91697846|NCT03452488|183290272|SUPERIORITY|||||||0.3526|||||||ANCOVA|||||||0.3526
91697847|NCT03315286|183290282|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91697848|NCT03315286|183290283|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91697849|NCT03315286|183290284|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline results are reported here.||||0.6
91697850|NCT03315286|183290284|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||6 month data is reported here||||0.3
91697851|NCT03315286|183290285|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline data is reported here.||||0.2
91697852|NCT03315286|183290285|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||6 month data is reported here||||0.4
91697853|NCT03315286|183290286|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||baseline data is reported here||||0.07
91491570|NCT00873912|182855817|NON_INFERIORITY_OR_EQUIVALENCE|Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.|rate difference|-1.3|||||TWO_SIDED|95.0|-7.9|1.3|||score statistic|||The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage points.||1.3|-7.9|
91491571|NCT00147446|182855862|SUPERIORITY_OR_OTHER||Wilcoxon two smaple test statistics|2.09||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that treatment with stress management produced a significant reduction in cumulative Gd+ lesions compared to the control condition during the treatment period||||0.04
91491572|NCT00147446|182855862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.02|TWO_SIDED|95.0|1.17|6.55|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving stress management remained free of Gd+ lesions during the treatment, compared to those receiving the control condition.||6.55|1.17|0.02
91697854|NCT03315286|183290286|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||6 month data is reported here||||0.0002
91697855|NCT02989649|183290338|OTHER||Least Square Mean (LSM)|-1.25|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-1.44|-1.05|||Regression, Linear||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|<0.001
91697856|NCT02989649|183290339|OTHER|||||||0.423|||||||Regression, Linear|||Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used||||0.423
91697857|NCT02989649|183290339|OTHER|||||||0.747|||||||Regression, Linear|||Statistical analysis for subgroup: Sex, Male or Female||||0.747
91697858|NCT02989649|183290339|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Age, \<45 or \>=45 to \<65 years or \>=65 years||||<0.001
91697859|NCT02989649|183290339|OTHER|||||||0.99|||||||Regression, Linear|||Statistical analysis for subgroup: Cardiovascular risk group, Yes or No||||0.990
91697860|NCT02989649|183290339|OTHER|||||||0.841|||||||Regression, Linear|||Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy||||0.841
91697861|NCT02989649|183290339|OTHER|||||||0.847|||||||Regression, Linear|||Statistical analysis for subgroup: Baseline BMI, \<25 or 25 to \<30 or \>=30 kg/m\^2||||0.847
91697862|NCT02989649|183290339|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Initial glycemic control, \<7% or \>=7%||||<0.001
91697863|NCT02989649|183290342|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.29|-0.62|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.62|-1.29|
91729547|NCT00452400|183354745|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.159|0.246|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.246|0.159|<0.0001
91729548|NCT00452400|183354746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.131|0.243|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.243|0.131|<0.0001
91729549|NCT00452400|183354746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.159|0.271|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.271|0.159|<0.0001
91729550|NCT00452400|183354746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.163|0.273|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.273|0.163|<0.0001
91729551|NCT00452400|183354746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.191|0.304|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.304|0.191|<0.0001
91729552|NCT00452400|183354747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.1|0.219|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.219|0.100|<0.0001
91697864|NCT02989649|183290342|OTHER||Least Square Mean (LSM)|-0.87|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|-1.36|-0.39|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-0.39|-1.36|
91697865|NCT02989649|183290343|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-1.18|-0.72|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.72|-1.18|
91697866|NCT02989649|183290343|OTHER||Least Square Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-1.44|-1.05|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|
91697867|NCT00281632|183290347|SUPERIORITY_OR_OTHER||Reponse rate|31.0||||||95.0|16.3|48.1|||||50% Response Rate (Normalized and Non-Normalized)|||48.1|16.3|
91697868|NCT00281632|183290351|SUPERIORITY_OR_OTHER||Response rate|17.6||||||95.0|3.8|43.4|||||Response rate (CR+PR)|||43.4|3.8|
91697869|NCT00281632|183290351|SUPERIORITY_OR_OTHER||Response rate|21.1||||||95.0|6.1|45.6|||||Response rate (CR+PR)|||45.6|6.1|
91697870|NCT00281632|183290351|SUPERIORITY_OR_OTHER||Response rate|19.4||||||95.0|8.2|36.0|||||Response rate (CR+PR)|||36.0|8.2|
91491573|NCT00147446|182855863|SUPERIORITY_OR_OTHER||Wilcoxon two sample test statistics|2.84||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that participants receiving SMT-MS showed a significant reduction in cumulative new T2 lesions, compared to those receiving the control condition during the treatment period.||||0.005
91491574|NCT00147446|182855863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07||||0.006|TWO_SIDED|95.0|1.38|6.81|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.||6.81|1.38|0.006
91697871|NCT01876784|183290371|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.08|TWO_SIDED|95.0|0.55|1.03||Threshold for significance at 0.05 level.|Log Rank||Vandetanib 300 mg vs Placebo|A multiple testing procedure (MTP) with an alpha-exhaustive recycling strategy was employed to provide adequate control of type I error.||1.03|0.55|0.080
91697872|NCT00732758|183290389|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.||||||0.003
91697873|NCT00732758|183290390|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|unadjusted p-values||||||0.51
91697874|NCT00732758|183290391|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
91697875|NCT00732758|183290392|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
91697876|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-7.3|-0.1||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-7.3|
91729553|NCT00452400|183354747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.134|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.253|0.134|<0.0001
91729554|NCT00452400|183354747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.262|0.144|<0.0001
91729555|NCT00452400|183354747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.145|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.264|0.145|<0.0001
91491575|NCT02302807|182855864|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4134|TWO_SIDED|95.0|0.63|1.21|||Log Rank|||||1.21|0.63|0.4134
91491576|NCT02302807|182855864|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.71|1.05||||||||1.05|0.71|
91697877|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-10.9|-0.1||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-10.9|
91697878|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-7.9||||||95.0|-12.4|-4.0||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-4.0|-12.4|
91697879|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.7|3.5||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.5|-2.7|
91697880|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.6||||||95.0|-4.7|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.7|
91697881|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.4|3.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.4|-2.4|
91697882|NCT00373958|183290393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-8.5|1.2||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-8.5|
91697883|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.8||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
91697884|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.74||||||95.0|0.61|0.89||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.61|
91491577|NCT02302807|182855864|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||||0.99|0.73|
91697885|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.62|0.85||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.85|0.62|
91697886|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
91729556|NCT00452400|183354748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.101|0.209|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.209|0.101|<0.0001
91491578|NCT01980940|182855882|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|5.09|||||TWO_SIDED|90.0|4.03|6.42|||ANOVA|||The geometric least squares mean ratio (GLSMR) and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||6.42|4.03|
91491579|NCT01980940|182855882|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|7.3|||||TWO_SIDED|90.0|6.05|8.81|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||8.81|6.05|
91697887|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.81||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.81|0.57|
91697888|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|1.18||||||95.0|0.98|1.41||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.41|0.98|
91697889|NCT00373958|183290394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.54|0.78||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.78|0.54|
91697890|NCT00373958|183290395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|0.1||||||95.0|-2.9|3.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||3.1|-2.9|
91697891|NCT00373958|183290395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.6||||||95.0|-8.3|7.0||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||7.0|-8.3|
91697892|NCT00373958|183290395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.4||||||95.0|-4.3|3.5||||||For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||3.5|-4.3|
91697893|NCT00373958|183290395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|1.7||||||95.0|-2.1|5.6||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.||5.6|-2.1|
91697894|NCT00373958|183290395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.9||||||95.0|-5.2|3.4||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.||3.4|-5.2|
91697895|NCT00373958|183290395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-2.1||||||95.0|-6.4|2.0||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.||2.0|-6.4|
91729557|NCT00452400|183354748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.131|0.239|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.239|0.131|<0.0001
91729558|NCT00452400|183354748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.178|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.178|<0.0001
91729559|NCT00452400|183354748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.177|0.286|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.286|0.177|<0.0001
91729560|NCT00452400|183354749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.264|0.140|<0.0001
91729561|NCT00452400|183354749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.169|0.294|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.294|0.169|<0.0001
91729562|NCT00452400|183354749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.172|0.295|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.295|0.172|<0.0001
91729563|NCT00452400|183354749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.197|0.322|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.322|0.197|<0.0001
91729564|NCT00452400|183354750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.101|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.228|0.101|<0.0001
91729565|NCT00452400|183354750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.125|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.125|<0.0001
91729566|NCT00452400|183354750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.266|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.266|0.140|<0.0001
91729567|NCT00452400|183354750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.137|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.265|0.137|<0.0001
91729568|NCT00452400|183354751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.039||0.2392||95.0|-0.03|0.121|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.121|-0.030|0.2392
91729569|NCT00452400|183354751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.038||0.0001||95.0|0.072|0.222|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.222|0.072|0.0001
91729570|NCT00452400|183354751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.099|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.253|0.099|<0.0001
91697896|NCT00373958|183290396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||1.7|-1.6|
91729571|NCT00452400|183354751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.039||0.0001||95.0|0.076|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.228|0.076|0.0001
91729572|NCT00452400|183354752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.0309||95.0|0.008|0.162|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.162|0.008|0.0309
91729573|NCT00452400|183354752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.098|0.25|||ANCOVA||Olo 2 mcg qd minus Placebo|||0.250|0.098|<0.0001
91697897|NCT00373958|183290396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.6||||||95.0|-7.1|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.||3.8|-7.1|
91697898|NCT00373958|183290396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|-0.8||||||95.0|-4.5|2.9||||||For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||2.9|-4.5|
91697899|NCT00373958|183290396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|3.6||||||95.0|-4.7|11.9||||||For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||11.9|-4.7|
91697900|NCT00373958|183290396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|1.2||||||95.0|-4.4|6.9||||||For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.||6.9|-4.4|
91697901|NCT00373958|183290396|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.8||||||95.0|-3.4|13.0||||||For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.||13.0|-3.4|
91729574|NCT00452400|183354752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.072|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.228|0.072|0.0002
91729575|NCT00452400|183354752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.039||0.0006||95.0|0.059|0.214|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.214|0.059|0.0006
91729576|NCT00452400|183354753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.215||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2150
91729577|NCT00452400|183354753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
91729578|NCT00452400|183354753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.043||0.023||95.0|0.014|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.184|0.014|0.0230
91491580|NCT01980940|182855882|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.45|||||TWO_SIDED|90.0|0.38|0.55|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.55|0.38|
91729579|NCT00452400|183354753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.043||0.0333||95.0|0.007|0.177|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.177|0.007|0.0333
91729580|NCT00452400|183354754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.2158||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2158
91729581|NCT00452400|183354754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
91729582|NCT00452400|183354754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.043||0.0013||95.0|0.055|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.225|0.055|0.0013
91729583|NCT00452400|183354754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.043||0.0376||95.0|0.005|0.174|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.174|0.005|0.0376
91729584|NCT00452400|183354755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.705|STANDARD_ERROR_OF_MEAN|5.916||0.0211|TWO_SIDED|95.0|2.07|25.34|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||25.340|2.070|0.0211
91729585|NCT00452400|183354755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.285|STANDARD_ERROR_OF_MEAN|5.951||0.0004|TWO_SIDED|95.0|9.581|32.99|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||32.990|9.581|0.0004
91491581|NCT01980940|182855882|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.65|||||TWO_SIDED|90.0|0.51|0.83|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.83|0.51|
91491582|NCT01980940|182855884|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|9.32|||||TWO_SIDED|90.0|4.77|18.18|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||18.18|4.77|
91729586|NCT00452400|183354755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.077|STANDARD_ERROR_OF_MEAN|5.832|<|0.0001|TWO_SIDED|95.0|26.607|49.546|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||49.546|26.607|<.0001
91729587|NCT00452400|183354755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.063|STANDARD_ERROR_OF_MEAN|5.99||0.0001|TWO_SIDED|95.0|11.282|34.845|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||34.845|11.282|0.0001
91729588|NCT00452400|183354756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.446|STANDARD_ERROR_OF_MEAN|6.283||0.0973|TWO_SIDED|95.0|-1.911|22.803|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||22.803|-1.911|0.0973
91729589|NCT00452400|183354756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.333|STANDARD_ERROR_OF_MEAN|6.36||0.0005|TWO_SIDED|95.0|9.824|34.842|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||34.842|9.824|0.0005
91729590|NCT00452400|183354756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.232|STANDARD_ERROR_OF_MEAN|6.192|<|0.0001|TWO_SIDED|95.0|26.054|50.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||50.409|26.054|<.0001
91729591|NCT00452400|183354756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.408|STANDARD_ERROR_OF_MEAN|6.403|<|0.0001|TWO_SIDED|95.0|12.814|38.002|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||38.002|12.814|<.0001
91729592|NCT00452400|183354757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.364||0.1541|TWO_SIDED|95.0|-1.237|0.196|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.196|-1.237|0.1541
91729593|NCT00452400|183354757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.367||0.7065|TWO_SIDED|95.0|-0.583|0.859|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.859|-0.583|0.7065
91729594|NCT00452400|183354757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.964|STANDARD_ERROR_OF_MEAN|0.359||0.0076|TWO_SIDED|95.0|-1.671|-0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.258|-1.671|0.0076
91729595|NCT00452400|183354757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|STANDARD_ERROR_OF_MEAN|0.369||0.2626|TWO_SIDED|95.0|-1.138|0.311|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.311|-1.138|0.2626
91729596|NCT03378635|183354768|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test. Kaplan-Meier estimate with 95% CI, p-value based on treatment group difference between dasiglucagon and placebo using a two-sided log-rank test stratified by injection site. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.||||<0.001
91729597|NCT03378635|183354769|SUPERIORITY||||||<|0.001||||||p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|Fisher Exact|||Pairwise test of independent binomial proportions with Fisher's Exact test comparing dasiglucagon versus placebo. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.001
91491583|NCT01980940|182855884|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|8.12|||||TWO_SIDED|90.0|6.39|10.32|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||10.32|6.39|
91491584|NCT01980940|182855884|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.47|||||TWO_SIDED|90.0|0.39|0.57|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.57|0.39|
91759062|NCT01853878|183411285|EQUIVALENCE|P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)|Hazard Ratio (HR)|4.592||||0.1422|TWO_SIDED|95.0|0.6|35.167|||Regression, Cox|||Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment \[Chemotherapy (CT) vs. no-CT\] and disease stage.||35.167|0.600|0.1422
91759063|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.008
91759064|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||0.040
91759065|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 months||||0.033
91759066|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.500
91759067|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.750
91759068|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.156
91759069|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.938
91759070|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.250
91759071|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.999
91759072|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.057
91729598|NCT03378635|183354770|SUPERIORITY||||||<|0.001||||||The p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|ANCOVA|||Plasma glucose (PG) change from baseline at rescue was carried forward in patients who required rescue intravenous (IV) glucose before reaching PG recovery. Change from baseline was analyzed using an ANCOVA, with treatment group as fixed effect and baseline PG as covariate. Group difference was evaluated inferentially following an a priori defined hierarchical test order, proceeding until the first failure to reject the null hypothesis.||||<0.001
91729599|NCT03378635|183354771|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% confidence interval, p-value based on a pairwise two-sided log-rank test versus placebo.||||<0.001
91729600|NCT03378635|183354772|SUPERIORITY||Mean Difference (Net)|0.131|||<|0.001|TWO_SIDED|95.0|0.1|0.171|||ANCOVA|||The log-transformed AUC endpoint was analyzed using an analysis of covariance model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences were back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% confidence interval.||0.171|0.1|<0.001
91729601|NCT03378635|183354773|SUPERIORITY||Mean Difference (Net)|0.91||||0.144|TWO_SIDED|95.0|0.801|1.033|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||1.033|0.801|0.144
91729602|NCT03378635|183354774|SUPERIORITY||Mean Difference (Net)|0.844||||0.006|TWO_SIDED|95.0|0.749|0.951|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||0.951|0.749|0.006
91528419|NCT00708305|182932213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.01|||<|0.0001|TWO_SIDED|95.0|0.73|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.73|<0.0001
91729603|NCT02474901|183354782|EQUIVALENCE|Looked for statistically-significant difference in numbers of adverse events between the two groups, used a p-value of 0.05 as the cutoff value for significance.|||||<|0.05|||||||Chi-squared, Corrected|Groups were compared with Yates-corrected chi-square test or Fisher exact test for binary or categorical variables.||||||<0.05
91729604|NCT01044693|183354811|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||0.036
91729605|NCT01044693|183354811|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||<0.001
91729606|NCT01044693|183354811|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||>0.05
91729607|NCT01044693|183354812|SUPERIORITY_OR_OTHER|||||||0.607|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.607
91729608|NCT01044693|183354813|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.597
91729609|NCT01044693|183354814|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.||||0.996
91729610|NCT01316900|183354822|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.142|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.142|0.039|<0.001
91729611|NCT01316900|183354822|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.141||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Tio 18 µg.|||0.141|0.039|<0.001
91729612|NCT01316900|183354822|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.140|0.036|<0.001
91729613|NCT01316900|183354822|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.140|0.036|<0.001
91729614|NCT01703221|183354829|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-0.96|-0.63|||Constrained longitudinal analysis|Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.63|-0.96|<0.001
91729615|NCT01703221|183354829|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.78|||<|0.001|TWO_SIDED|95.0|-0.94|-0.61|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.61|-0.94|<0.001
91491585|NCT01980940|182855884|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.41|||||TWO_SIDED|90.0|0.21|0.79|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.79|0.21|
91729616|NCT01703221|183354829|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).|Difference in the least squares means|-0.02||||0.792|TWO_SIDED|95.0|-0.15|0.12|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||0.12|-0.15|0.792
91729617|NCT01703221|183354834|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-36.89|||<|0.001|TWO_SIDED|95.0|-48.46|-25.33|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-25.33|-48.46|<0.001
91729618|NCT01703221|183354834|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-39.76|||<|0.001|TWO_SIDED|95.0|-51.28|-28.23|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-28.23|-51.28|<0.001
91729619|NCT01703221|183354834|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.86||||0.555|TWO_SIDED|95.0|-6.67|12.39|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||12.39|-6.67|0.555
91729620|NCT01703221|183354835|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-12.28|||<|0.001|TWO_SIDED|95.0|-17.78|-6.78|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-6.78|-17.78|<0.001
91729621|NCT01703221|183354835|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-14.51|||<|0.001|TWO_SIDED|95.0|-20.04|-8.98|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-8.98|-20.04|<0.001
91491586|NCT01980940|182855885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.3|STANDARD_ERROR_OF_MEAN|21.57||0.2113|TWO_SIDED|90.0|-63.6|8.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||8.9|-63.6|0.2113
91491587|NCT01980940|182855885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|19.66||0.2548|TWO_SIDED|90.0|-55.7|10.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||10.3|-55.7|0.2548
91729622|NCT01703221|183354835|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.23||||0.33|TWO_SIDED|95.0|-2.27|6.73|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||6.73|-2.27|0.330
91729623|NCT03061214|183354885|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
91729624|NCT03061214|183354885|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
91729625|NCT03061214|183354885|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
91729626|NCT03061214|183354885|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
91729627|NCT06844812|183354970|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
91729628|NCT06844812|183354971|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|paired t-test||||||0.021
91729629|NCT06844812|183354972|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|paired t-test||||||0.003
91729630|NCT06844812|183354973|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91729631|NCT06844812|183354974|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91729632|NCT02006836|183354976|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 1 sided|||H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people \> 0 α=5%||||0.005
91491588|NCT01980940|182855885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4|STANDARD_ERROR_OF_MEAN|19.94||0.288|TWO_SIDED|90.0|-54.9|12.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||12.0|-54.9|0.2880
91729633|NCT02006836|183354977|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast \> 0 α=5%~* g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~* g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."||||>0.05
91729634|NCT02006836|183354978|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch \> 0 α=5%~* g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch.~* g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch."||||>0.05
91729635|NCT02006836|183354979|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner \> 0 α=5%~* g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner.~* g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner."||||>0.05
91729636|NCT02006836|183354980|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||H0: AUC||||>0.05
91513241|NCT04382326|182898009|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.08|||||TWO_SIDED|95.0|0.85|1.38||||||Mumps: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.38|0.85|
91729637|NCT02683954|183354981|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.||||0.05
91729638|NCT02410200|183354982|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Signed Rank test|||||||0.0090
91729639|NCT01500135|183355022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|STANDARD_ERROR_OF_MEAN|0.72||0.276|TWO_SIDED|95.0|0.68|3.88||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||3.88|0.68|0.276
91729640|NCT01500135|183355023|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.684|TWO_SIDED|95.0|0.4|1.82||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||1.82|0.40|0.684
91729641|NCT01500135|183355024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.684|TWO_SIDED|95.0|0.7|1.8||P-value was adjusted using Hochberg's adjustment for multiplicity.|Proportional Hazard Model|||||1.8|0.7|0.684
91729642|NCT01362530|183355062|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
91729643|NCT01362530|183355063|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.05
91729644|NCT01362530|183355064|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
91491589|NCT01980940|182855885|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|19.52||0.3709|TWO_SIDED|90.0|-50.4|15.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||15.1|-50.4|0.3709
91729645|NCT01362530|183355065|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
91729646|NCT01557569|183355066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.413|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||Due to skewed data, Kruskal Wallis Test was used.||||<0.05
91729647|NCT02254460|183355067|SUPERIORITY_OR_OTHER||[Treatment difference]|1.74||||0.0944|TWO_SIDED|95.0|0.9|3.34|||ANOVA||Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).|||3.34|0.90|0.0944
91759073|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.031
91759074|NCT01846741|183411300|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.625
91759075|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0008
91759076|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0544|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure Score||||0.0544
91759077|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0207|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0207
91759078|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0163|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0163
91759079|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0156
91759080|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0742
91759081|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0884|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0884
91759082|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0007
91759083|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.1173
91759084|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0214
91759085|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0114
91759086|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0078
91759087|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0875|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0875
91759088|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.1526|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.1526
91729648|NCT01633112|183355073|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.0138|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.0138
91729649|NCT01633112|183355073|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.4153|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.4153
91729650|NCT01633112|183355074|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
91729651|NCT01633112|183355074|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
91729652|NCT01633112|183355076|OTHER||||||<|0.0001|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||<0.0001
91729653|NCT01633112|183355076|OTHER|||||||0.006|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||0.0060
91729654|NCT01633112|183355077|OTHER|||||||0.0167|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .||||||0.0167
91729655|NCT01633112|183355077|OTHER|||||||0.0011|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||0.0011
91729656|NCT01633112|183355078|OTHER|||||||0.0052|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0052
91491590|NCT01980940|182855885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|19.81||0.3883|TWO_SIDED|90.0|-50.5|16.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||16.0|-50.5|0.3883
91513242|NCT04382326|182898010|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.23|||||TWO_SIDED|95.0|1.02|1.48||||||Rubella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.48|1.02|
91729657|NCT01633112|183355078|OTHER|||||||0.0636|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0636
91729658|NCT01633112|183355079|OTHER|||||||0.0011||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0011
91729659|NCT01633112|183355079|OTHER|||||||0.0146||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0146
91729660|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729661|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729662|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729663|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729664|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729665|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729666|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729667|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729668|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91513243|NCT04382326|182898011|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.99|||||TWO_SIDED|95.0|0.84|1.17||||||Varicella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution)||1.17|0.84|
91697902|NCT00373958|183290397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.75|1.17||||||For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.75|
91697903|NCT00373958|183290398|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08||||||For Measles the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.85|
91697904|NCT00373958|183290398|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||For Mumps the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.87|
91697905|NCT00373958|183290398|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.1||||||For Varicella the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.92|
91697906|NCT00373958|183290399|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78|||||TWO_SIDED|95.0|0.62|1.0||||||For Rubella the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.62|
91697907|NCT01552915|183290404|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-2.1|STANDARD_ERROR_OF_MEAN|1.15||0.0717|TWO_SIDED|95.0|-4.3|0.2|||mixed effects model for repeated measure|||||0.2|-4.3|0.0717
91697908|NCT01552915|183290404|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-12.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-15.1|-9.4|||mixed effects model for repeated measure|||||-9.4|-15.1|<0.0001
91697909|NCT01552915|183290404|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-10.1|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|-13.0|-7.3|||mixed effects model for repeated measure|||||-7.3|-13.0|<0.0001
91697910|NCT01552915|183290405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6165|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6165
91697911|NCT01552915|183290405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91697912|NCT01552915|183290405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91697913|NCT01777568|183290409|SUPERIORITY||Risk Ratio (RR)|0.99||||0.85|TWO_SIDED|95.0|0.85|1.14|||GEE model||Relative Risk: 80% (numerator) vs. 30% (denominator)|||1.14|0.85|0.85
91697914|NCT01777568|183290410|SUPERIORITY||Risk Ratio (RR)|0.8||||0.047|TWO_SIDED|95.0|0.66|1.01|||Chi-squared|||||1.01|0.66|0.047
91697915|NCT00282113|183290422|SUPERIORITY_OR_OTHER||||||>|0.5||95.0|||||Mixed-effects regression|||||||>0.5
91697916|NCT00282113|183290423|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91697917|NCT00282113|183290424|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
91697918|NCT03382834|183290426|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)||||||0.68
91697919|NCT03382834|183290428|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
91697920|NCT02120833|183290452|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91513244|NCT00618657|182898012|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
91697921|NCT02120833|183290452|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.4360
91697922|NCT02120833|183290452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.62||0.051|TWO_SIDED|95.0|-2.51|0.01||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.01|-2.51|0.0510
91697923|NCT02120833|183290453|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0004
91697924|NCT02120833|183290453|SUPERIORITY_OR_OTHER|||||||0.0213|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0213
91697925|NCT02120833|183290453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.7698|TWO_SIDED|95.0|-0.5|0.37|||ANCOVA|The significance threshold level was 0.05 (two-sided).||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.37|-0.50|0.7698
91697926|NCT02120833|183290454|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0003
91697927|NCT02120833|183290454|SUPERIORITY_OR_OTHER|||||||0.6063|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6063
91697928|NCT02120833|183290454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.43||0.3686|TWO_SIDED|95.0|-1.27|0.48||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-1.27|0.3686
91697929|NCT02120833|183290455|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697930|NCT02120833|183290455|SUPERIORITY_OR_OTHER|||||||0.6118|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6118
91697931|NCT02120833|183290455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.56||0.1485|TWO_SIDED|95.0|-1.98|0.31||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.98|0.1485
91697932|NCT02120833|183290456|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697933|NCT02120833|183290456|SUPERIORITY_OR_OTHER|||||||0.2447|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2447
91697934|NCT02120833|183290456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.67||0.0216|TWO_SIDED|95.0|-2.95|-0.25||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.25|-2.95|0.0216
91697935|NCT02120833|183290457|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697936|NCT02120833|183290457|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0476
91697937|NCT02120833|183290457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.78||0.2349|TWO_SIDED|95.0|-2.52|0.64||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.64|-2.52|0.2349
91697938|NCT02120833|183290458|SUPERIORITY_OR_OTHER|||||||0.7842|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.7842
91697939|NCT02120833|183290458|SUPERIORITY_OR_OTHER|||||||0.6083|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6083
91697940|NCT02120833|183290458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3599|TWO_SIDED|95.0|-0.08|0.22||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.08|0.3599
91697941|NCT02120833|183290459|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0001
91697942|NCT02120833|183290459|SUPERIORITY_OR_OTHER|||||||0.0317|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0317
91697943|NCT02120833|183290459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.19||0.8037|TWO_SIDED|95.0|-0.42|0.33||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.33|-0.42|0.8037
91697944|NCT02120833|183290460|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697945|NCT02120833|183290460|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0244
91697946|NCT02120833|183290460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.8|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.06|-0.80|0.0900
91697947|NCT02120833|183290461|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697948|NCT02120833|183290461|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0065
91729669|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729670|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91491591|NCT01980940|182855886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|9.32||0.1383|TWO_SIDED|90.0|-29.7|1.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||1.6|-29.7|0.1383
91491592|NCT01980940|182855886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.66||0.238|TWO_SIDED|90.0|-24.9|4.2|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.2|-24.9|0.2380
91491593|NCT01980940|182855886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|8.53||0.2691|TWO_SIDED|90.0|-23.9|4.8|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.8|-23.9|0.2691
91491594|NCT01980940|182855886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.15||0.3246|TWO_SIDED|90.0|-21.8|5.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||5.6|-21.8|0.3246
91513245|NCT00618657|182898012|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
91697949|NCT02120833|183290461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.97|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.16|-0.97|0.1561
91697950|NCT02120833|183290462|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697951|NCT02120833|183290462|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0049
91697952|NCT02120833|183290462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|STANDARD_ERROR_OF_MEAN|4.71||0.2409|TWO_SIDED|95.0|-3.88|15.07||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.07|-3.88|0.2409
91697953|NCT02120833|183290463|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697954|NCT02120833|183290463|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2386
91697955|NCT02120833|183290463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|STANDARD_ERROR_OF_MEAN|3.98||0.0241|TWO_SIDED|95.0|1.28|17.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.32|1.28|0.0241
91697956|NCT02120833|183290464|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91729671|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91697957|NCT02120833|183290464|SUPERIORITY_OR_OTHER|||||||0.0696|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0696
91697958|NCT02120833|183290464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|4.23||0.0394|TWO_SIDED|95.0|0.46|17.52||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.52|0.46|0.0394
91697959|NCT02120833|183290465|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91697960|NCT02120833|183290465|SUPERIORITY_OR_OTHER|||||||0.0772|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0772
91697961|NCT02120833|183290465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|3.54||0.0213|TWO_SIDED|95.0|1.33|15.63||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.63|1.33|0.0213
91697962|NCT02120833|183290466|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91491595|NCT01980940|182855886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.19||0.3881|TWO_SIDED|90.0|-20.9|6.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||6.6|-20.9|0.3881
91491596|NCT01980940|182855887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.3|STANDARD_ERROR_OF_MEAN|68.25||0.4477|TWO_SIDED|90.0|-166.8|62.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.3|-166.8|0.4477
91528420|NCT00708305|182932214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.5545|TWO_SIDED|95.0|-0.22|0.47||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.47|-0.22|0.5545
91697963|NCT02120833|183290466|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0172
91491597|NCT01980940|182855887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.7|STANDARD_ERROR_OF_MEAN|65.42||0.6084|TWO_SIDED|90.0|-143.6|76.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||76.1|-143.6|0.6084
91528421|NCT00708305|182932214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4||||0.0003|TWO_SIDED|95.0|0.15|0.71||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.71|0.15|0.0003
91697964|NCT02120833|183290466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.56|STANDARD_ERROR_OF_MEAN|3.48||0.1968|TWO_SIDED|95.0|-2.46|11.58||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||11.58|-2.46|0.1968
91697965|NCT02120833|183290467|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
91729672|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729673|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729674|NCT01633112|183355080|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||0.0005
91697966|NCT02120833|183290467|SUPERIORITY_OR_OTHER|||||||0.0712|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0712
91729675|NCT01633112|183355080|OTHER||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0051
91729676|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729677|NCT01633112|183355080|OTHER|||||||0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||0.0051
91729678|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729679|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
91729680|NCT01633112|183355080|OTHER|||||||0.0068|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||0.0068
91729681|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729682|NCT01633112|183355080|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
91729683|NCT01633112|183355080|OTHER|||||||0.4595|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||0.4595
91729684|NCT01633112|183355081|OTHER|||||||0.1045|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1045
91491598|NCT01980940|182855887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.2|STANDARD_ERROR_OF_MEAN|65.25||0.5926|TWO_SIDED|90.0|-144.7|74.4|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||74.4|-144.7|0.5926
91729685|NCT01633112|183355081|OTHER|||||||0.1358|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1358
91729686|NCT04019704|183355103|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91729687|NCT01550965|183355104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||paired t-test, 2 sided|||Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||18.73|16.08|<0.001
91729688|NCT01550965|183355105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1383.81|||<|0.001|TWO_SIDED|95.0|-1586.36|-1181.26|||Paired t-test, 2 sided|||Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||-1181.26|-1586.36|<0.001
91729689|NCT01550965|183355106|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1297.77|||<|0.001|TWO_SIDED|95.0|-1562.17|-1033.36|||Paired t-test, 2 sided|||||-1033.36|-1562.17|<0.001
91729690|NCT01550965|183355107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4308.32|||<|0.001|TWO_SIDED|95.0|-4985.13|-3631.51|||Paired t-test, 2 sided|||||-3631.51|-4985.13|<0.001
91729691|NCT01550965|183355108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|||<|0.001|TWO_SIDED|95.0|-9.83|-4.78|||Paired t-test, 2 sided|||||-4.78|-9.83|<0.001
91729692|NCT01550965|183355109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|||<|0.001|TWO_SIDED|95.0|21.5|27.25|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.||27.25|21.50|<0.001
91729693|NCT01550965|183355109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.95|||<|0.001|TWO_SIDED|95.0|15.42|22.48|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.||22.48|15.42|<0.001
91729694|NCT01550965|183355109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|||<|0.001|TWO_SIDED|95.0|3.89|8.5|||Paired t-test, 2 sided)|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.||8.50|3.89|<0.001
91729695|NCT01550965|183355109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6|||<|0.001|TWO_SIDED|95.0|19.55|25.64|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.||25.64|19.55|<0.001
91729696|NCT01550965|183355110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.85|||<|0.001|TWO_SIDED|95.0|-5.42|-4.27|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization.||-4.27|-5.42|<0.001
91729697|NCT01550965|183355110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.11|0.09|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during emergency department visits.||0.09|-0.11|0.830
91729698|NCT01550965|183355110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.18|-0.66|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.||-0.66|-1.18|<0.001
91729699|NCT01550965|183355111|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||McNemar|||Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.||||<0.001
91729700|NCT01550965|183355112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||<|0.001|TWO_SIDED|95.0|10.21|12.02|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.||12.02|10.21|<0.001
91729701|NCT01550965|183355112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||<|0.001|TWO_SIDED|95.0|14.2|16.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.||16.56|14.20|<0.001
91729702|NCT01550965|183355112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.77|||<|0.001|TWO_SIDED|95.0|13.57|15.96|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||15.96|13.57|<0.001
91729703|NCT01550965|183355112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.||18.73|16.08|<0.001
91729704|NCT01550965|183355113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 2.||-0.57|-0.69|<0.001
91729705|NCT01550965|183355113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001|TWO_SIDED|95.0|-1.16|-1.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 8.||-1.00|-1.16|<0.001
91491599|NCT01980940|182855887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|62.49||0.5022|TWO_SIDED|90.0|-147.2|62.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.6|-147.2|0.5022
91697967|NCT02120833|183290467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43|STANDARD_ERROR_OF_MEAN|3.34||0.0313|TWO_SIDED|95.0|0.7|14.15||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||14.15|0.70|0.0313
91697968|NCT02397122|183290527|SUPERIORITY|||||||0.259|||||||Mann-Whitney|||Baseline||||0.259
91697969|NCT02397122|183290527|SUPERIORITY|||||||0.097|||||||Mann-Whitney|||6 weeks||||0.097
91697970|NCT02397122|183290527|SUPERIORITY|||||||0.07||||||\<0.05|Mann-Whitney U|||6 months||||0.070
91697971|NCT02397122|183290528|SUPERIORITY|||||||0.067|||||||Mann-Whitney|||Baseline||||0.067
91697972|NCT02397122|183290528|SUPERIORITY|||||||0.13|||||||Mann-Whitney|||6 weeks||||0.130
91697973|NCT02397122|183290528|SUPERIORITY|||||||0.128||||||\<0.05|Mann-Whitney U|||6 months||||0.128
91697974|NCT02397122|183290529|SUPERIORITY|||||||0.298|||||||Mann-Whitney|||Baseline||||0.298
91697975|NCT02397122|183290529|SUPERIORITY|||||||0.152|||||||Mann-Whitney|||6 weeks||||0.152
91697976|NCT02397122|183290529|SUPERIORITY|||||||0.317||||||\<0.05|Mann-Whitney U|||6 months||||0.317
91697977|NCT02397122|183290530|SUPERIORITY|||||||0.136|||||||Mann-Whitney|||Baseline||||0.136
91697978|NCT02397122|183290530|SUPERIORITY|||||||0.041|||||||Mann-Whitney|||6 weeks||||0.041
91697979|NCT02397122|183290530|SUPERIORITY|||||||0.064||||||\<0.05|Mann-Whitney U|||6 months||||0.064
91697980|NCT02397122|183290531|SUPERIORITY|||||||0.245|||||||Mann-Whitney|||Baseline||||0.245
91697981|NCT02397122|183290531|SUPERIORITY|||||||0.099|||||||Mann-Whitney|||6 weeks||||0.099
91697982|NCT02397122|183290531|SUPERIORITY|||||||0.077|||||||Mann-Whitney U|||||||0.077
91697983|NCT02397122|183290532|SUPERIORITY|||||||0.946|||||||Mann-Whitney|||Baseline||||0.946
91697984|NCT02397122|183290532|SUPERIORITY|||||||0.001|||||||Mann-Whitney|||6 weeks||||0.001
91697985|NCT02397122|183290532|SUPERIORITY|||||||0.001||||||\<0.05|Mann-Whitney U|||6 months||||0.001
91697986|NCT02438826|183290533|SUPERIORITY||LSMean Difference|-0.8||||0.334|TWO_SIDED|95.0|-2.77|1.17||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||1.17|-2.77|0.334
91697987|NCT02438826|183290534|SUPERIORITY||Odds Ratio (OR)|1.297||||0.17|TWO_SIDED|95.0|0.83|2.028||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||2.028|0.830|0.170
91697988|NCT02438826|183290535|SUPERIORITY|||||||0.946||||||Chui, Hung, Wang (CHW) procedure applied)|Mixed Models Analysis|||||||0.946
91697989|NCT02438826|183290536|SUPERIORITY||Odds Ratio (OR)|1.51||||0.057|TWO_SIDED|95.0|0.987|2.309|||Mixed Models Analysis|||||2.309|0.987|0.057
91697990|NCT02438826|183290537|SUPERIORITY||Odds Ratio (OR)|1.141||||0.713|TWO_SIDED|95.0|0.563|2.314|||Mixed Models Analysis|||||2.314|0.563|0.713
91697991|NCT02438826|183290538|SUPERIORITY||Odds Ratio (OR)|1.008||||0.979|TWO_SIDED|95.0|0.548|1.856|||Mixed Models Analysis|||||1.856|0.548|0.979
91697992|NCT02438826|183290539|SUPERIORITY||Odds Ratio (OR)|0.788||||0.437|TWO_SIDED|95.0|0.431|1.44|||Mixed Models Analysis|||||1.440|0.431|0.437
91697993|NCT01500187|183290552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.636|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baseline||||0.636
91697994|NCT01500187|183290552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three months||||0.001
91697995|NCT01500187|183290552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six months||||0.423
91697996|NCT02784613|183290553|SUPERIORITY|||||||0.05||||||Differences in pre- and post-treatment scores were compared using Wilcoxon signed-rank test for non-parametric matched pairs. All tests of significance were 2-tailed. All analyses were performed in Stata®, version 13.|t-test, 2 sided|||||||0.05
91697997|NCT00586820|183290559|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
91697998|NCT00586820|183290560|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 8 hours post PCI.||||0.019
91697999|NCT00586820|183290560|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 16 hours post-PCI.||||0.007
91698000|NCT00688662|183290574|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.6||||0.01|TWO_SIDED|95.0|-28.0|-3.3||The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.|Regression, Logistic|Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.|The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).|The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome ('success') in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O'Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.||-3.3|-28.0|0.01
91698001|NCT00688662|183290575|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-24.1|5.9||A confidence interval approach was used for examining this outcome.||||Only patients with abnormal manometry were included in this subgroup analysis.||5.9|-24.1|
91698002|NCT01483027|183290576|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0013|TWO_SIDED|95.0|0.54|0.88|||Log Rank|||Analysis performed using a log-rank test||0.88|0.54|0.0013
91698003|NCT01483027|183290577|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.77|||Log Rank|||Analysis performed using a log-rank test.||0.77|0.46|<0.0001
91729706|NCT01550965|183355113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-0.95|-0.77|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-0.77|-0.95|<0.001
91729707|NCT01550965|183355113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.23|-1.06|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 26.||-1.06|-1.23|<0.001
91729708|NCT01550965|183355114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|||<|0.001|TWO_SIDED|95.0|-3.46|-2.99|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 2.||-2.99|-3.46|<0.001
91729709|NCT01550965|183355114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06|||<|0.001|TWO_SIDED|95.0|-4.37|-3.76|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 8.||-3.76|-4.37|<0.001
91729710|NCT01550965|183355114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01|||<|0.001|TWO_SIDED|95.0|-3.36|-2.66|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-2.66|-3.36|<0.001
91729711|NCT01550965|183355114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|||<|0.001|TWO_SIDED|95.0|-4.43|-3.72|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 26.||-3.72|-4.43|<0.001
91729712|NCT01550965|183355115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.08|0.11|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.||0.11|0.08|<0.001
91729713|NCT01550965|183355115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.11|0.15|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.||0.15|0.11|<0.001
91729714|NCT01550965|183355115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.001|TWO_SIDED|95.0|0.1|0.14|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||0.14|0.10|<0.001
91729715|NCT01550965|183355115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.12|0.17|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.||0.17|0.12|<0.001
91729716|NCT01550965|183355116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-12.07|-5.18|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.||-5.18|-12.07|<0.001
91729717|NCT01550965|183355116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.27|-8.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.||-8.16|-16.27|<0.001
91729718|NCT01550965|183355116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.61|||<|0.001|TWO_SIDED|95.0|-15.82|-7.4|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-7.40|-15.82|<0.001
91729719|NCT01550965|183355116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-15.5|-7.35|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.||-7.35|-15.50|<0.001
91729720|NCT01550965|183355117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.56|||<|0.001|TWO_SIDED|95.0|-20.0|-13.12|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.||-13.12|-20.00|<0.001
91729721|NCT01550965|183355117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.95|||<|0.001|TWO_SIDED|95.0|-26.93|-18.97|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.||-18.97|-26.93|<0.001
91528422|NCT00708305|182932214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.56|0.58|<0.0001
91729722|NCT01550965|183355117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.68|||<|0.001|TWO_SIDED|95.0|-25.69|-17.67|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-17.67|-25.69|<0.001
91729723|NCT01550965|183355117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.45|||<|0.001|TWO_SIDED|95.0|-28.33|-20.58|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.||-20.58|-28.33|<0.001
91729724|NCT01550965|183355118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.34|||<|0.001|TWO_SIDED|95.0|-22.1|-14.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.||-14.57|-22.10|<0.001
91729725|NCT01550965|183355118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.54|||<|0.001|TWO_SIDED|95.0|-31.08|-22.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.||-22.00|-31.08|<0.001
91729726|NCT01550965|183355118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.33|||<|0.001|TWO_SIDED|95.0|-29.97|-20.7|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-20.70|-29.97|<0.001
91729727|NCT01550965|183355118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.22|||<|0.001|TWO_SIDED|95.0|-33.5|-24.93|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.||-24.93|-33.50|<0.001
91729728|NCT01550965|183355119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001|TWO_SIDED|95.0|-20.47|-15.85|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.||-15.85|-20.47|<0.001
91729729|NCT01550965|183355119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.43|||<|0.001|TWO_SIDED|95.0|-28.3|-22.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.||-22.56|-28.30|<0.001
91729730|NCT01550965|183355119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.42|||<|0.001|TWO_SIDED|95.0|-27.33|-21.5|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-21.50|-27.33|<0.001
91729731|NCT01550965|183355119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.22|||<|0.001|TWO_SIDED|95.0|-30.28|-24.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.||-24.16|-30.28|<0.001
91729732|NCT03464461|183355218|OTHER|non-parametric||||||0.9844|||||||Kruskal-Wallis|||||||0.9844
91729733|NCT03464461|183355219|OTHER|non-parametric||||||0.158|||||||Kruskal-Wallis|||||||0.1580
91729734|NCT03464461|183355220|OTHER|non-parametric||||||0.873|||||||Kruskal-Wallis|||||||0.8730
91729735|NCT03464461|183355221|OTHER|non-parametric||||||0.074|||||||Kruskal-Wallis|||||||0.0740
91729736|NCT03464461|183355222|OTHER|non-parametric||||||0.0984|||||||Kruskal-Wallis|||||||0.0984
91729737|NCT05524948|183355223|OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.71|-0.9|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.90|-1.71|<0.0001
91729738|NCT05524948|183355224|OTHER||Adjusted Mean Difference|-569.64|STANDARD_ERROR_OF_MEAN|97.479|<|0.0001|TWO_SIDED|95.0|-763.11|-376.17|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-376.17|-763.11|<0.0001
91729739|NCT05524948|183355225|OTHER||Adjusted Mean Difference|-418.86|STANDARD_ERROR_OF_MEAN|64.848|<|0.0001|TWO_SIDED|95.0|-547.56|-290.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-290.15|-547.56|<0.0001
91729740|NCT05524948|183355225|OTHER||Adjusted Mean Difference|-108.9|STANDARD_ERROR_OF_MEAN|32.626||0.0012|TWO_SIDED|95.0|-173.66|-44.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-44.15|-173.66|0.0012
91729741|NCT05524948|183355225|OTHER||Adjusted Mean Difference|-26.17|STANDARD_ERROR_OF_MEAN|22.909||0.2561|TWO_SIDED|95.0|-71.64|19.29|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||19.29|-71.64|0.2561
91729742|NCT05524948|183355226|OTHER||Adjusted Mean Difference|-721.58|STANDARD_ERROR_OF_MEAN|94.584|<|0.0001|TWO_SIDED|95.0|-909.31|-533.86|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-533.86|-909.31|<0.0001
91729743|NCT05524948|183355227|OTHER||Adjusted Mean Difference|-567.89|STANDARD_ERROR_OF_MEAN|68.09|<|0.0001|TWO_SIDED|95.0|-703.03|-432.75|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-432.75|-703.03|<0.0001
91729744|NCT05524948|183355227|OTHER||Adjusted Mean Difference|-105.39|STANDARD_ERROR_OF_MEAN|24.57|<|0.0001|TWO_SIDED|95.0|-154.15|-56.62|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-56.62|-154.15|<0.0001
91729745|NCT05524948|183355227|OTHER||Adjusted Mean Difference|-38.04|STANDARD_ERROR_OF_MEAN|26.201||0.1498|TWO_SIDED|95.0|-90.04|13.97|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||13.97|-90.04|0.1498
91729746|NCT05524948|183355228|OTHER||Adjusted Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.204|<|0.0001|TWO_SIDED|95.0|-2.58|-1.77|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-1.77|-2.58|<0.0001
91729747|NCT05524948|183355229|OTHER||Adjusted Mean Difference|-396.96|STANDARD_ERROR_OF_MEAN|95.541|<|0.0001|TWO_SIDED|95.0|-586.51|-207.41|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-207.41|-586.51|<0.0001
91729748|NCT05524948|183355230|OTHER||Adjusted Mean Difference|-341.37|STANDARD_ERROR_OF_MEAN|72.446|<|0.0001|TWO_SIDED|95.0|-485.1|-197.64|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-197.64|-485.10|<0.0001
91729749|NCT05524948|183355230|OTHER||Adjusted Mean Difference|-74.15|STANDARD_ERROR_OF_MEAN|20.905||0.0006|TWO_SIDED|95.0|-115.62|-32.68|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-32.68|-115.62|0.0006
91698004|NCT03010800|183290581|SUPERIORITY|||||||0.0469||||||One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.|Wilcoxon (Mann-Whitney)|||"Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.~A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected."||||0.0469
91729750|NCT05524948|183355230|OTHER||Adjusted Mean Difference|27.98|STANDARD_ERROR_OF_MEAN|25.942||0.2834|TWO_SIDED|95.0|-23.49|79.45|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||79.45|-23.49|0.2834
91729751|NCT05524948|183355231|OTHER||Adjusted Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-1.83|-1.28|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as the experimental dentifrice minus the reference dentifrice.|||-1.28|-1.83|<0.0001
91729752|NCT05524948|183355232|OTHER||Adjusted Mean Difference|-322.75|STANDARD_ERROR_OF_MEAN|67.778|<|0.0001|TWO_SIDED|95.0|-457.27|-188.23|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-188.23|-457.27|<0.0001
91729753|NCT05524948|183355233|OTHER||Adjusted Mean Difference|-250.33|STANDARD_ERROR_OF_MEAN|42.838|<|0.0001|TWO_SIDED|95.0|-335.35|-165.3|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-165.30|-335.35|<0.0001
91698005|NCT04463251|183290582|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
91729754|NCT05524948|183355233|OTHER||Adjusted Mean Difference|-45.53|STANDARD_ERROR_OF_MEAN|23.439||0.055|TWO_SIDED|95.0|-92.05|0.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||0.99|-92.05|0.0550
91729755|NCT05524948|183355233|OTHER||Adjusted Mean Difference|-32.68|STANDARD_ERROR_OF_MEAN|26.036||0.2124|TWO_SIDED|95.0|-84.36|18.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||18.99|-84.36|0.2124
91729756|NCT05524948|183355234|OTHER||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|-1.52|-0.87|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.87|-1.52|<0.0001
91729757|NCT05155085|183355235|SUPERIORITY||Risk Difference (RD)|5.1||||0.4662|TWO_SIDED|95.0|-9.8|19.8|||Cochran-Mantel-Haenszel|||||19.8|-9.8|0.4662
91729758|NCT05155085|183355236|SUPERIORITY||LSM Difference from Placebo|-9.7|STANDARD_ERROR_OF_MEAN|11.4||0.3968|TWO_SIDED|95.0|-32.2|12.9|||Mixed Models Analysis|||||12.9|-32.2|0.3968
91729759|NCT05155085|183355237|SUPERIORITY||Risk Difference (RD)|3.3||||0.7625|TWO_SIDED|95.0|-15.2|21.6|||Fisher Exact|||||21.6|-15.2|0.7625
91729760|NCT03460704|183355239|SUPERIORITY||LS Mean rate ratio|1.004||||0.97889|TWO_SIDED|95.0|0.747|1.349|||negative binomial model|||The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, country, and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-exposure time on treatment as an offset.||1.349|0.747|0.97889
91729761|NCT01767857|183355248|SUPERIORITY|||||||0.613|||||||Log Rank|||||||0.613
91729762|NCT01767857|183355249|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
91729763|NCT01767857|183355250|SUPERIORITY|||||||0.541|||||||ANCOVA|||Statistical Analysis for Global Health Status/Qol||||0.541
91729764|NCT01767857|183355250|SUPERIORITY|||||||0.56|||||||ANCOVA|||Statistical Analysis for Pain||||0.560
91729765|NCT01767857|183355250|SUPERIORITY|||||||0.603|||||||ANCOVA|||Statistical Analysis for Fatigue||||0.603
91729766|NCT01767857|183355250|SUPERIORITY|||||||0.485|||||||ANCOVA|||Statistical Analysis for Appetite Loss||||0.485
91729767|NCT01767857|183355251|SUPERIORITY|||||||0.21|||||||ANCOVA|||||||0.210
91729768|NCT01767857|183355252|SUPERIORITY|||||||0.768|||||||Log Rank|||||||0.768
91729769|NCT01421459|183355255|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|0.052||||0.403|TWO_SIDED|95.0|-0.07|0.175|||ANCOVA|||||0.175|-0.070|0.403
91729770|NCT01421459|183355257|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value is for 4 weeks.|ANCOVA|||||||0.382
91729771|NCT01421459|183355257|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for 8 weeks.|ANCOVA|||||||0.910
91729772|NCT01421459|183355257|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for 12 weeks.|ANCOVA|||||||0.869
91729773|NCT01421459|183355257|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for 16 weeks.|ANCOVA|||||||0.345
91729774|NCT01421459|183355257|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for 20 weeks.|ANCOVA|||||||0.161
91729775|NCT01421459|183355257|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value is for 24 weeks.|ANCOVA|||||||0.097
91729776|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is at Morning Pre-Meal at Baseline.|ANCOVA|||||||0.837
91729777|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value is for Morning 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.620
91729778|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value is for Midday Pre-Meal at Baseline|ANCOVA|||||||0.107
91729779|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Midday 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.258
91729780|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Evening Pre-Meal at Baseline.|ANCOVA|||||||0.161
91729781|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for Bed Time at Baseline.|ANCOVA|||||||0.725
91729782|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-value is for 0300 hrs at Baseline.|ANCOVA|||||||0.543
91729783|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.|ANCOVA|||||||0.265
91729784|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.050
91729785|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.040
91729786|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.366
91729787|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.485||95.0||||P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.485
91729788|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for Bed Time at Endpoint, up to 24 weeks.|ANCOVA|||||||0.537
91729789|NCT01421459|183355258|SUPERIORITY_OR_OTHER|||||||0.878||95.0||||P-value is for 0300 hrs at Endpoint, up to 24 weeks.|ANCOVA|||||||0.878
91729790|NCT01421459|183355259|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Baseline.|ANCOVA|||||||0.779
91729791|NCT01421459|183355259|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||||0.788
91729792|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value is for Baseline.|ANCOVA|||||||0.687
91729793|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value is for change at 4 wks.|ANCOVA|||||||0.036
91729794|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||P-value is for change at 8 wks.|ANCOVA|||||||0.323
91729795|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value is for change at 12 wks.|ANCOVA|||||||0.368
91729796|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for change at 16 wks.|ANCOVA|||||||0.089
91729797|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value is for change at 20 wks.|ANCOVA|||||||0.041
91729798|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||P-value is for change at 24 wks.|ANCOVA|||||||0.330
91729799|NCT01421459|183355260|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value is for change at Endpoint, up to 24 wks.|ANCOVA|||||||0.334
91729800|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Behavior domain at 4 weeks.|ANCOVA|||||||0.726
91729801|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for Behavior domain at 12 weeks.|ANCOVA|||||||0.502
91513246|NCT02710630|182898017|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|119.33|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|101.838|139.834|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||139.834|101.838|
91729802|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-value is for Behavior domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.437
91729803|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||P-value is for Worry domain at 4 weeks.|ANCOVA|||||||0.237
91729804|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||P-value is for Worry domain at 12 weeks.|ANCOVA|||||||0.860
91729805|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for Worry domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.966
91729806|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||P-value is for ALBSS Total Score at 4 weeks.|ANCOVA|||||||0.313
91729807|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||P-value is for ALBSS Total Score at 12 weeks.|ANCOVA|||||||0.683
91729808|NCT01421459|183355261|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.765
91729809|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for Inconvenience of Regimen at 4 weeks.|ANCOVA|||||||0.983
91729810|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Inconvenience of Regimen at 12 weeks.|ANCOVA|||||||0.371
91729811|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.|ANCOVA|||||||0.757
91729812|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||P-value is for Lifestyle Flexibility at 4 weeks.|ANCOVA|||||||0.890
91729813|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||P-value is for Lifestyle Flexibility at 12 weeks.|ANCOVA|||||||0.326
91729814|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.|ANCOVA|||||||0.831
91729815|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value is for Hypoglycemic Control at 4 weeks.|ANCOVA|||||||0.507
91729816|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Hypoglycemic Control at 12 weeks.|ANCOVA|||||||0.690
91729817|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.307
91729818|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Glycemic Control at 4 weeks.|ANCOVA|||||||0.902
91729819|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||P-value is for Glycemic Control at 12 weeks.|ANCOVA|||||||0.109
91729820|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value is for Glycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.754
91729821|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||P-value is for Insulin Deliver Device at 4 weeks.|ANCOVA|||||||0.088
91729822|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||P-value is for Insulin Delivery Device at 12 weeks.|ANCOVA|||||||0.456
91729823|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.|ANCOVA|||||||0.531
91729824|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value is for ITSQ Total Score at 4 weeks.|ANCOVA|||||||0.393
91729825|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||P-value is for ITSQ Total Score at 12 weeks.|ANCOVA|||||||0.296
91729826|NCT01421459|183355262|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.662
91729827|NCT01421459|183355263|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||ANCOVA|||||||0.393
91729828|NCT01421459|183355264|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value is for Insulin Dose at Endpoint, up to 24 weeks.|ANOVA|||||||0.185
91513247|NCT02710630|182898017|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|52.97|STANDARD_DEVIATION|168.9|||TWO_SIDED|90.0|33.341|84.158|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||84.158|33.341|
91729829|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||P-value is for HbA1c \<7% at Baseline.|Chi-squared|||||||0.661
91729830|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value is for HbA1c ≤ 6.5% at Baseline.|Chi-squared|||||||0.394
91729831|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for HbA1c \<7% at 4 weeks.|Chi-squared|||||||0.688
91729832|NCT01421459|183355265|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-value is for HbA1c ≤ 6.5% at 4 weeks.|Chi-squared|||||||>0.999
91491600|NCT01980940|182855887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.0|STANDARD_ERROR_OF_MEAN|63.7||0.5125|TWO_SIDED|90.0|-149.0|64.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||64.9|-149.0|0.5125
91491601|NCT01980940|182855888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2632|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 2 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.2632
91528423|NCT00708305|182932214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.36|||<|0.0001|TWO_SIDED|95.0|0.15|0.68||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signal Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.68|0.15|<0.0001
91528424|NCT00708305|182932214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.58|<0.0001
91729833|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.409||95.0||||P-value is for HbA1c \<7% at 8 weeks.|Chi-squared|||||||0.409
91729834|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for HbA1c ≤ 6.5% at 8 weeks.|Chi-squared|||||||0.090
91729835|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value is for HbA1c \<7% at 12 weeks.|Chi-squared|||||||0.319
91729836|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value is for HbA1c ≤6.5% at 12 weeks.|Chi-squared|||||||0.463
91491602|NCT01980940|182855888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4703|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 4 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.4703
91528425|NCT00708305|182932214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.56|0.26|<0.0001
91729837|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for HbA1c \<7% at 16 weeks.|Chi-squared|||||||0.128
91729838|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value is for HbA1c ≤6.5% at 16 weeks.|Chi-squared|||||||0.261
91729839|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is for HbA1c \<7% at 20 weeks.|Chi-squared|||||||0.218
91528426|NCT00708305|182932215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.6865|TWO_SIDED|95.0|-0.13|0.08||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.08|-0.13|0.6865
91528427|NCT00708305|182932215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.1756|TWO_SIDED|95.0|-0.02|0.12||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.12|-0.02|0.1756
91729840|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for HbA1c ≤6.5% at 20 weeks.|Chi-squared|||||||0.092
91729841|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value is for HbA1c \<7%% at 24 weeks.|Chi-squared|||||||0.186
91729842|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for HbA1c ≤6.5% at 24 weeks.|Chi-squared|||||||0.174
91729843|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value is for HbA1c \<7% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.340
91729844|NCT01421459|183355265|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.293
91729845|NCT01421459|183355266|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.594
91729846|NCT01421459|183355266|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.462
91729847|NCT01421459|183355267|SUPERIORITY_OR_OTHER|||||||0.995||95.0||||P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.995
91729848|NCT01421459|183355267|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.686
91729849|NCT01421459|183355268|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value is for Baseline.|Chi-squared|||||||0.285
91729850|NCT01421459|183355268|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.047
91729851|NCT01421459|183355268|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.882
91729852|NCT01421459|183355268|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.179
91729853|NCT01421459|183355268|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||P-value is for Endpoint, up to 24 weeks.|Chi-squared|||||||0.314
91491603|NCT01980940|182855888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 7 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.5507
91729854|NCT01421459|183355268|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value is for Baseline to 24 weeks (Overall).|Chi-squared|||||||0.100
91729855|NCT01421459|183355269|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.176
91729856|NCT01421459|183355269|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.999
91729857|NCT01421459|183355269|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.618
91729858|NCT01421459|183355269|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||P-value is for Endpoint (LOCF).|Chi-squared|||||||0.874
91729859|NCT01421459|183355269|SUPERIORITY_OR_OTHER||||||>|0.233||95.0||||P-value is for Overall (Baseline to 24 weeks).|Chi-squared|||||||>0.233
91729860|NCT00967499|183355272|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||||||0.4010
91729861|NCT00967499|183355273|SUPERIORITY|||||||0.5672|||||||Cochran-Mantel-Haenszel|||||||0.5672
91729862|NCT00967499|183355274|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.0570
91729863|NCT00967499|183355275|SUPERIORITY|||||||0.515|||||||Cochran-Mantel-Haenszel|||||||0.5150
91729864|NCT00967499|183355276|SUPERIORITY|||||||0.3601||||||P-values are based on Cochran-Mantel-Haenszel row mean score test with gender adjustment for the ranks of the change from baseline values.|Cochran-Mantel-Haenszel|||||||0.3601
91729865|NCT00967499|183355277|SUPERIORITY|||||||0.3453|||||||Mann-Whitney Test|||24 hours postdose||||0.3453
91729866|NCT00967499|183355277|SUPERIORITY|||||||0.7874|||||||Mann-Whitney Test|||48 hours postdose||||0.7874
91729867|NCT00967499|183355277|SUPERIORITY|||||||0.8485|||||||Mann-Whitney Test|||72 Hours Postdose||||0.8485
91729868|NCT02899754|183355278|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Primary outcome assessed at 1 month post-intervention||||0.18
91729869|NCT02899754|183355280|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91729870|NCT02899754|183355281|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91729871|NCT02899754|183355282|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91729872|NCT02899754|183355283|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||0.22
91729873|NCT02899754|183355284|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
91729874|NCT02899754|183355285|SUPERIORITY|||||||0.01|||||||Chi-squared|||chi-square test||||0.01
91729875|NCT02899754|183355286|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
91729876|NCT02592655|183355330|SUPERIORITY_OR_OTHER|||||||0.002||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.002
91729877|NCT02592655|183355330|SUPERIORITY_OR_OTHER|||||||0.008||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.008
91729878|NCT02592655|183355330|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.5
91729879|NCT02592655|183355330|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 17 to accommodate for missing ultrasound data."||||0.5
91729880|NCT03000166|183355337|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
91729881|NCT03000166|183355338|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
91729882|NCT03000166|183355339|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
91729883|NCT03000166|183355340|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91729884|NCT05259722|183355386|SUPERIORITY||Mean Difference (Net)|-16.1|||<|0.001|TWO_SIDED|95.0|-23.28|-8.86|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-8.86|-23.28|<0.001
91729885|NCT05259722|183355387|SUPERIORITY||Risk Difference (RD)|12.6|||=|0.003|TWO_SIDED|95.0|4.34|20.78|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||20.78|4.34|=0.003
91729886|NCT05259722|183355388|SUPERIORITY||Risk Difference (RD)|10.6|||=|0.004|TWO_SIDED|95.0|3.31|17.87|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||17.87|3.31|=0.004
91729887|NCT05259722|183355389|SUPERIORITY||Mean Difference (Net)|-0.7|||=|0.005|TWO_SIDED|95.0|-1.12|-0.2|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.20|-1.12|=0.005
91729888|NCT05259722|183355390|SUPERIORITY||Mean Difference (Net)|-0.6|||=|0.018|TWO_SIDED|95.0|-1.08|-0.1|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.10|-1.08|=0.018
91729889|NCT05259722|183355391|SUPERIORITY||Mean Difference (Net)|14.3|||<|0.001|TWO_SIDED|95.0|5.81|22.86|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||22.86|5.81|<0.001
91729890|NCT05259722|183355392|SUPERIORITY||Mean Difference (Net)|334.0|||<|0.001|TWO_SIDED|95.0|195.69|472.26|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||472.26|195.69|<0.001
91729891|NCT05259722|183355393|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-32.55|-16.36|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-16.36|-32.55|<0.001
91729892|NCT00420056|183355401|SUPERIORITY_OR_OTHER|||||||0.4854|TWO_SIDED||||||Regression, Linear|||||||0.4854
91729893|NCT00420056|183355402|SUPERIORITY_OR_OTHER|||||||0.709|TWO_SIDED||||||Regression, Linear|||||||0.7090
91729894|NCT00420056|183355405|SUPERIORITY_OR_OTHER||Kappa|0.0638|||||TWO_SIDED|95.0|-0.0449|0.1726||||||FLT-PET response versus Objective response||0.1726|-0.0449|
91729895|NCT00420056|183355405|SUPERIORITY_OR_OTHER||Kappa|0.1864|||||TWO_SIDED|95.0|-0.2316|0.6045||||||FDG-PET response versus Objective response||0.6045|-0.2316|
91729896|NCT00420056|183355419|SUPERIORITY_OR_OTHER|||||||0.5954|TWO_SIDED||||||Regression, Linear|||Concentration versus Ki-67||||0.5954
91729897|NCT00420056|183355419|SUPERIORITY_OR_OTHER|||||||0.1286|TWO_SIDED||||||Regression, Linear|||Concentration versus Cyclin D1||||0.1286
91729898|NCT00420056|183355419|SUPERIORITY_OR_OTHER|||||||0.0956|TWO_SIDED||||||Regression, Linear|||Concentration versus phospho-Rb||||0.0956
91729899|NCT00420056|183355419|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Linear|||Concentration versus FLT-PET SUVmax||||0.2800
91729900|NCT00420056|183355419|SUPERIORITY_OR_OTHER|||||||0.4921|TWO_SIDED||||||Regression, Linear|||Concentration versus FDG-PET SUVmax||||0.4921
91729901|NCT03072875|183355451|OTHER|Descriptive statistic.|||||||||||||||||Quantitative data (descriptive statistic) from the USAQ were used to determine feasibility. Specifically, we established an a priori mean score of 3.5 or greater on the USAQ to determine feasibility.|||
91729902|NCT00907088|183355453|SUPERIORITY_OR_OTHER|||||||0.42|||||||Chi-squared|||||||0.42
91729903|NCT03726879|183355458|SUPERIORITY||Odds Ratio (OR)|0.67||||0.1846|TWO_SIDED|95.0|0.37|1.21||The threshold for statistical significance was a p-value =0.048|Cochran-Mantel-Haenszel|||||1.21|0.37|0.1846
91729904|NCT03726879|183355459|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9551|TWO_SIDED|95.0|0.67|1.46||The threshold for statistical significance was a p-value =0.002|Cochran-Mantel-Haenszel|||||1.46|0.67|0.9551
91729905|NCT03726879|183355462|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.59|||Log Rank|||All Participants||1.59|0.50|
91729906|NCT03726879|183355462|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.65|4.32|||Log Rank|||PD-L1 IC1/2/3||4.32|0.65|
91729907|NCT03726879|183355462|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.27|1.22|||Log Rank|||PD-L1 IC0 Participants||1.22|0.27|
91729908|NCT03726879|183355462|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.58|2.82|||Log Rank|||ER/PgR Negative Participants||2.82|0.58|
91729909|NCT03726879|183355462|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.24|1.36|||Log Rank|||ER/PgR Positive Participants||1.36|0.24|
91729910|NCT03726879|183355463|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.38|1.32|||Log Rank|||All Participants||1.32|0.38|
91729911|NCT03726879|183355463|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.51|3.69|||Log Rank|||PD-L1 IC1/2/3||3.69|0.51|
91729912|NCT03726879|183355463|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.19|1.02|||Log Rank|||PD-L1 IC0||1.02|0.19|
91729913|NCT03726879|183355464|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|2.0|||Log Rank|||All Participants||2.00|0.40|
91729914|NCT03726879|183355464|SUPERIORITY||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.33|||Log Rank|||PD-L1 IC1/2/3||7.33|0.42|
91729915|NCT03726879|183355464|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.21|1.59|||Log Rank|||PD-L1 IC0||1.59|0.21|
91729916|NCT03726879|183355478|SUPERIORITY||Hazard Ratio (HR)|2.38|||||TWO_SIDED|95.0|0.22|26.42|||Regression, Cox|||PIK3CA-Missing||26.42|0.22|
91729917|NCT03726879|183355478|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.9|||Regression, Cox|||PIK3CA-Mutated||1.90|0.23|
91729918|NCT03726879|183355478|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.45|1.87|||Regression, Cox|||PIK3CA-Wildtype||1.87|0.45|
91729919|NCT03726879|183355479|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.07|18.91|||Regression, Cox|||PIK3CA-Missing||18.91|0.07|
91729920|NCT03726879|183355479|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.19|1.92||||||PIK3CA-Mutated||1.92|0.19|
91729921|NCT03726879|183355479|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.33|1.55|||Regression, Cox|||PIK3CA-Wildtype||1.55|0.33|
91729922|NCT03726879|183355480|SUPERIORITY||Hazard Ratio (HR)|999.99|||||TWO_SIDED|95.0|0.0||Upper limit of the CI was not evaluable due to low number of events||Regression, Cox||The estimated value is \>999.99|PIK3CA-Missing|||0.00|
91729923|NCT03726879|183355480|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.1|3.53|||Regression, Cox|||PIK3CA-Mutated||3.53|0.10|
91729924|NCT03726879|183355480|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.33|2.09|||Regression, Cox|||PIK3CA-Wildtype||2.09|0.33|
91729925|NCT02496156|183355481|SUPERIORITY||||||<|0.39||||||This is a computed p-value.|Mixed Models Analysis|||Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||<0.39
91729926|NCT02496156|183355482|SUPERIORITY||||||>|0.05||||||Computed p-value exceeded the .05 level of significance.|Mixed Models Analysis||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
91729927|NCT02496156|183355483|SUPERIORITY||||||>|0.05||||||This is a computed p-value.|Mixed Models Analysis|||See description of analysis below.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
91729928|NCT02496156|183355484|SUPERIORITY||||||>|0.05||||||Computed p-value|ANCOVA|Difference in post-test scores with baseline Knowledge test score as the covariate.||||||>0.05
91729929|NCT02496156|183355486|SUPERIORITY|See analysis description below.|||||>|0.05||||||Computed p-value|ANOVA||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
91729930|NCT00507507|183355487|SUPERIORITY_OR_OTHER|||||||0.016||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||The null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference. The sample size provided at least 85% power to detect a difference of 30% between the groups, assuming response rates of 30% and 60% in the Tenofovir DF and FTC+Tenofovir DF groups, respectively.||||0.016
91729931|NCT00507507|183355488|SUPERIORITY_OR_OTHER|||||||0.05||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.050
91729932|NCT00507507|183355488|SUPERIORITY_OR_OTHER|||||||0.009||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.009
91491604|NCT01980940|182855888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3992|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 11 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3992
91491605|NCT01980940|182855888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6626|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 14 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.6626
91729933|NCT00507507|183355488|SUPERIORITY_OR_OTHER|||||||0.03||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.030
91729934|NCT00507507|183355489|SUPERIORITY_OR_OTHER|||||||0.703||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.703
91729935|NCT00507507|183355489|SUPERIORITY_OR_OTHER|||||||0.034||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.034
91729936|NCT00507507|183355489|SUPERIORITY_OR_OTHER|||||||0.011||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.011
91729937|NCT00507507|183355489|SUPERIORITY_OR_OTHER|||||||0.007||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.007
91729938|NCT00507507|183355490|SUPERIORITY_OR_OTHER|||||||0.01||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.010
91729939|NCT00507507|183355491|SUPERIORITY_OR_OTHER|||||||0.019||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.019
91729940|NCT00507507|183355492|SUPERIORITY_OR_OTHER|||||||0.186||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.186
91729941|NCT00507507|183355493|SUPERIORITY_OR_OTHER|||||||0.07||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.070
91729942|NCT00507507|183355494|SUPERIORITY_OR_OTHER|||||||0.467||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.467
91729943|NCT00507507|183355494|SUPERIORITY_OR_OTHER|||||||1||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||1.000
91729944|NCT00507507|183355494|SUPERIORITY_OR_OTHER|||||||0.529||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.529
91729945|NCT00507507|183355494|SUPERIORITY_OR_OTHER|||||||0.451||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.451
91729946|NCT00507507|183355495|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
91729947|NCT00507507|183355495|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
91729948|NCT00507507|183355495|SUPERIORITY_OR_OTHER|||||||0.365||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.365
91729949|NCT00507507|183355496|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
91729950|NCT00507507|183355496|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
91729951|NCT00507507|183355496|SUPERIORITY_OR_OTHER|||||||0.244||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.244
91729952|NCT00289900|183355500|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.2|||<|0.001|TWO_SIDED|95.0|-16.8|-9.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.6|-16.8|<0.001
91729953|NCT00289900|183355500|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.8|-7.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-7.8|-13.8|<0.001
91729954|NCT00289900|183355500|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.1|||<|0.001|TWO_SIDED|95.0|-8.1|-2.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.1|-8.1|<0.001
91729955|NCT00289900|183355500|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.2||||0.007|TWO_SIDED|95.0|-7.2|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-7.2|0.007
91729956|NCT00289900|183355501|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|19.9|||<|0.001|TWO_SIDED|95.0|17.2|22.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||22.6|17.2|<0.001
91729957|NCT00289900|183355501|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|21.3|||<|0.001|TWO_SIDED|95.0|19.0|23.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||23.6|19.0|<0.001
91729958|NCT00289900|183355501|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|22.1|||<|0.001|TWO_SIDED|95.0|19.8|24.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||24.4|19.8|<0.001
91729959|NCT00289900|183355501|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|23.0|||<|0.001|TWO_SIDED|95.0|20.7|25.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||25.3|20.7|<0.001
91729960|NCT00289900|183355502|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-17.3|||<|0.001|TWO_SIDED|95.0|-21.2|-13.3|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test|||-13.3|-21.2|<0.001
91729961|NCT00289900|183355502|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-19.1|-11.9|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-11.9|-19.1|<0.001
91729962|NCT00289900|183355502|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-7.0|-13.7|<0.001
91729963|NCT00289900|183355502|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-3.4|-10.2|<0.001
91729964|NCT00289900|183355503|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|||<|0.001|TWO_SIDED|95.0|-12.1|-6.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.0|-12.1|<0.001
91729965|NCT00289900|183355503|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.4|||<|0.001|TWO_SIDED|95.0|-8.0|-2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.9|-8.0|<0.001
91729966|NCT00289900|183355503|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.4||||0.771|TWO_SIDED|95.0|-2.2|2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.9|-2.2|0.771
91729967|NCT00289900|183355503|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.4||||0.065|TWO_SIDED|95.0|-0.2|5.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.0|-0.2|0.065
91729968|NCT00289900|183355504|SUPERIORITY_OR_OTHER||Difference in least Squares Mean|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.5|-10.2|<0.001
91729969|NCT00289900|183355504|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.0||||0.037|TWO_SIDED|95.0|-5.8|-0.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-0.2|-5.8|0.037
91729970|NCT00289900|183355504|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.8||||0.047|TWO_SIDED|95.0|0.0|5.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.6|0.0|0.047
91491606|NCT01980940|182855888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.315|||||||Jonckheere-Terpstra test|||Treatment comparison of post-trial PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3150
91491607|NCT03187197|182855919|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 2.||||0.0001
91491608|NCT03187197|182855919|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 3.||||0.0001
91491609|NCT03187197|182855919|OTHER|||||||0.0031|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 2.||||0.0031
91491610|NCT03187197|182855919|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 3.||||0.0001
91491611|NCT03187197|182855920|OTHER|||||||0.7879|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment convenience before PSM.||||0.7879
91729971|NCT00289900|183355504|SUPERIORITY_OR_OTHER||Difference in Least Sqaures Mean|4.7|||<|0.001|TWO_SIDED|95.0|2.0|7.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||7.5|2.0|<0.001
91729972|NCT00289900|183355505|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.2|||<|0.001|TWO_SIDED|95.0|-12.1|-6.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.3|-12.1|<0.001
91729973|NCT00289900|183355505|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.2|||<|0.001|TWO_SIDED|95.0|-7.7|-2.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.8|-7.7|<0.001
91729974|NCT00289900|183355505|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9||||0.476|TWO_SIDED|95.0|-3.3|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-3.3|0.476
91729975|NCT00289900|183355505|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.2||||0.845|TWO_SIDED|95.0|-2.2|2.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.7|-2.2|0.845
91729976|NCT00289900|183355506|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|6.6|11.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||11.4|6.6|<0.001
91729977|NCT00289900|183355506|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|7.7|||<|0.001|TWO_SIDED|95.0|5.8|9.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||9.7|5.8|<0.001
91729978|NCT00289900|183355506|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|7.0|10.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||10.9|7.0|<0.001
91729979|NCT00289900|183355506|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|10.7|||<|0.001|TWO_SIDED|95.0|8.7|12.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||12.7|8.7|<0.001
91729980|NCT00289900|183355507|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.6||||0.003|TWO_SIDED|95.0|-6.0|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-6.0|0.003
91729981|NCT00289900|183355507|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.595|TWO_SIDED|95.0|-2.5|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-2.5|0.595
91729982|NCT00289900|183355507|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||6.2|2.2|<0.001
91729983|NCT00289900|183355507|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|6.1|||<|0.001|TWO_SIDED|95.0|4.1|8.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||8.1|4.1|<0.001
91729984|NCT00289900|183355508|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.8|||<|0.001|TWO_SIDED|95.0|-24.2|-14.2|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-14.2|-24.2|<0.001
91729985|NCT00289900|183355508|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-25.0|-16.6|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-16.6|-25.0|<0.001
91729986|NCT00289900|183355508|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.9|||<|0.001|TWO_SIDED|95.0|-27.8|-19.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-19.4|-27.8|<0.001
91729987|NCT00289900|183355508|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-24.6|||<|0.001|TWO_SIDED|95.0|-28.6|-20.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-20.0|-28.6|<0.001
91729988|NCT00289900|183355509|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.5|TWO_SIDED|95.0|-9.6|7.5|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||7.5|-9.6|0.500
91491612|NCT03187197|182855920|OTHER|||||||0.611|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment convenience before PSM.||||0.6110
91491613|NCT03187197|182855920|OTHER|||||||0.0832|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment satisfaction before PSM.||||0.0832
91491614|NCT03187197|182855920|OTHER|||||||0.6488|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment satisfaction before PSM.||||0.6488
91491615|NCT03187197|182855920|OTHER|||||||0.1301|||||||Two sample T test|||Between group comparison of Visit 2 treatment convenience after PSM.||||0.1301
91729989|NCT00289900|183355509|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.9||||0.083|TWO_SIDED|95.0|0.0|13.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||13.8|0.0|0.083
91729990|NCT00289900|183355509|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.9||||0.005|TWO_SIDED|95.0|5.2|18.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||18.8|5.2|0.005
91729991|NCT00289900|183355509|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.4|||<|0.001|TWO_SIDED|95.0|9.8|22.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||22.8|9.8|<0.001
91729992|NCT00289900|183355510|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.8|||<|0.001|TWO_SIDED|95.0|-15.6|-9.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.9|-15.6|<0.001
91729993|NCT00289900|183355510|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.2|-8.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-8.4|-13.2|<0.001
91729994|NCT00289900|183355510|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.4||||0.001|TWO_SIDED|95.0|-8.8|-4.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-4.0|-8.8|0.001
91729995|NCT00289900|183355510|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.6|||<|0.001|TWO_SIDED|95.0|-8.0|-3.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.2|-8.0|<0.001
91729996|NCT00289900|183355511|SUPERIORITY_OR_OTHER||Difference in Proportion|-1.4||||0.008|TWO_SIDED|95.0|-2.3|-0.5|||Miettinen and Nurminen|||||-0.5|-2.3|0.008
91729997|NCT00289900|183355512|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.7||||0.042|TWO_SIDED|95.0|-1.4|0.0|||Miettinen and Nurminen|||||-0.0|-1.4|0.042
91729998|NCT00289900|183355513|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.1||||0.346|TWO_SIDED|95.0|-0.5|0.4|||Miettinen and Nurminen|||||0.4|-0.5|0.346
91729999|NCT00289900|183355514|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.556|TWO_SIDED|95.0|-0.2|0.7|||Miettinen and Nurminen|||||0.7|-0.2|0.556
91730000|NCT00289900|183355515|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134|TWO_SIDED|95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
91730001|NCT00289900|183355516|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134||95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
91730002|NCT00289900|183355517|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1||||0.5625|TWO_SIDED|95.0|-0.3|0.9|||Miettinen and Nurminen|||||0.9|-0.3|0.5625
91730003|NCT00289900|183355518|SUPERIORITY_OR_OTHER||Difference in Percentage|0.7||||0.0233|TWO_SIDED|95.0|0.1|1.7|||Miettinen and Nurminen|||||1.7|0.1|0.0233
91730004|NCT00289900|183355519|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.7858|TWO_SIDED|95.0|-0.4|0.6|||Miettinen and Nurminen|||||0.6|-0.4|0.7858
91491616|NCT03187197|182855920|OTHER|||||||0.1257|||||||Two sample T test|||Between group comparison of Visit 2 treatment satisfaction after PSM.||||0.1257
91730005|NCT00289900|183355520|SUPERIORITY_OR_OTHER||Difference in Percentage|13.7|||||TWO_SIDED|95.0|9.4|18.0|||Miettinen and Nurminen|||||18.0|9.4|
91730006|NCT00289900|183355521|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.7|||||TWO_SIDED|95.0|-2.6|1.4|||Miettinen and Nurminen|||||1.4|-2.6|
91730007|NCT00289900|183355522|SUPERIORITY_OR_OTHER||Difference in Percentage|11.7|||||TWO_SIDED|95.0|8.9|14.7|||Miettinen and Nurminen|||||14.7|8.9|
91730008|NCT00289900|183355523|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-0.8|0.9|||Miettinen and Nurminen|||||0.9|-0.8|
91730009|NCT00289900|183355524|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.4997|TWO_SIDED|95.0|-0.4|0.5|||Miettinen and Nurminen|||||0.5|-0.4|0.4997
91730010|NCT02656173|183355527|SUPERIORITY||least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.82|-0.21|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis, including treatment group and region as fixed factors and baseline as a covariate.||-0.21|-0.82|<0.001
91730011|NCT02656173|183355528|SUPERIORITY||least square mean difference|-0.48|||<|0.001|TWO_SIDED|95.0|-0.78|-0.17|||mixed model repeated measure|||Mixed Model Repeated Measure (MMRM) was used for analysis, which included the baseline as a covariate, treatment group, analysis visits and region as a fixed effect, subject as random effect and including interaction of \[treatment group x visit\] for FAS.||-0.17|-0.78|<0.001
91730012|NCT02656173|183355529|SUPERIORITY||least square mean difference|-0.28||||0.112|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.07|-0.63|0.112
91730013|NCT02656173|183355530|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|1.75||||0.186|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.186
91759089|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0031
91759090|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.0828
91759091|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0092
91491617|NCT00674700|182855953|SUPERIORITY_OR_OTHER|||||||0.0066||||||main effects = treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.0066
91698006|NCT04463251|183290582|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
91698007|NCT04463251|183290583|OTHER||Least square means ratio|0.54|||||TWO_SIDED|95.0|0.34|0.87|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.87|0.34|
91698008|NCT04463251|183290583|OTHER||Least square means ratio|0.6|||||TWO_SIDED|95.0|0.37|0.95|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.95|0.37|
91698009|NCT04463251|183290584|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
91698010|NCT04463251|183290584|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
91698011|NCT04463251|183290585|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
91698012|NCT04463251|183290585|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
91698013|NCT04463251|183290586|OTHER||Least square means ratio|0.52|||||TWO_SIDED|95.0|0.34|0.81||||||"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."|"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|0.81|0.34|
91698014|NCT04463251|183290586|OTHER||Least square means ratio|0.48|||||TWO_SIDED|95.0|0.31|0.74|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.74|0.31|
91759092|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0096
91759093|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0234|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0234
91759094|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0284|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0284
91759095|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.0679
91759096|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0003
91730014|NCT02656173|183355531|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|0.09||||0.76|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.760
91730015|NCT02656173|183355532|SUPERIORITY||Least square mean difference|-0.03||||0.646|TWO_SIDED|95.0|-0.18|0.11|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.11|-0.18|0.646
91730016|NCT02656173|183355533|SUPERIORITY||Least square mean difference|12.08|||<|0.001|TWO_SIDED|95.0|6.33|17.84|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||17.84|6.33|<0.001
91730017|NCT02656173|183355534|SUPERIORITY||Least square mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.26|-1.04|0.001
91730018|NCT02656173|183355535|SUPERIORITY||Least square mean difference|-0.11||||0.006|TWO_SIDED|95.0|-0.19|-0.03|||ANCOVA|||Subscale: Daytime Frequency. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.03|-0.19|0.006
91730019|NCT02656173|183355535|SUPERIORITY||Least square mean difference|-0.08||||0.174|TWO_SIDED|95.0|-0.19|0.03|||ANCOVA|||Subscale: Nighttime Frequency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.03|-0.19|0.174
91730020|NCT02656173|183355535|SUPERIORITY||Least square mean difference|-0.26||||0.037|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Subscale: Urgency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.02|-0.50|0.037
91730021|NCT02656173|183355535|SUPERIORITY||Least square mean difference|-0.18||||0.014|TWO_SIDED|95.0|-0.32|-0.04|||ANCOVA|||Subscale: Urgency Incontinence. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.04|-0.32|0.014
91730022|NCT02656173|183355536|SUPERIORITY||Least square mean difference|-1.19||||0.002|TWO_SIDED|95.0|-1.94|-0.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.44|-1.94|0.002
91730023|NCT02656173|183355537|SUPERIORITY||Least square mean difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Subscale: Storage Subscale. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.43|-1.13|<0.001
91730024|NCT02656173|183355537|SUPERIORITY||Least square mean difference|-0.3||||0.167|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||Subscale: Voiding Subscale-1. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.13|-0.72|0.167
91730025|NCT02656173|183355537|SUPERIORITY||Least square mean difference|-0.42||||0.103|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||Subscale: Voiding Subscale-2. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.09|-0.93|0.103
91730026|NCT02656173|183355537|SUPERIORITY||Least square mean difference|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07|||ANCOVA|||Subscale: Quality of Life (QoL) Item. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.07|-0.51|0.009
91730027|NCT02656173|183355538|SUPERIORITY||Least square mean difference|-4.52|||<|0.001|TWO_SIDED|95.0|-6.91|-2.13|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-2.13|-6.91|<0.001
91730028|NCT02656173|183355539|SUPERIORITY||Least square mean difference|2.79|||<|0.001|TWO_SIDED|95.0|1.13|4.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||4.44|1.13|<0.001
91730029|NCT03449147|183355547|SUPERIORITY||Estimated Relative Reduction (%)|-1.14||||0.875|TWO_SIDED|95.0|-14.27|14.02||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||14.02|-14.27|0.875
91730030|NCT03449147|183355547|SUPERIORITY||Estimated Relative Reduction (%)|-14.64||||0.031|TWO_SIDED|95.0|-26.07|-1.43||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-1.43|-26.07|0.031
91730031|NCT03449147|183355550|SUPERIORITY||Estimated Relative Reduction (%)|-3.03||||0.677|TWO_SIDED|95.0|-16.14|12.12||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||12.12|-16.14|0.677
91730032|NCT03449147|183355550|SUPERIORITY||Estimated Relative Reduction (%)|-15.79||||0.022|TWO_SIDED|95.0|-27.27|-2.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-2.50|-27.27|0.022
91698015|NCT04463251|183290587|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.29|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.29|
91698016|NCT04463251|183290587|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.3|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.30|
91698017|NCT00877487|183290668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.23|||<|0.0001|TWO_SIDED|95.0|-19.1|-11.4|||ANCOVA|||||-11.4|-19.1|<0.0001
91698018|NCT00877487|183290669|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91698019|NCT00877487|183290670|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91730033|NCT03449147|183355551|SUPERIORITY||Odds Ratio (OR)|1.34||||0.077|TWO_SIDED|95.0|0.97|1.85||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.85|0.97|0.077
91528428|NCT00708305|182932215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.38||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.38|0.16|<0.0001
91698020|NCT03425396|183290688|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.5|||||TWO_SIDED|95.0|-16.8|9.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.6|-16.8|
91730034|NCT03449147|183355551|SUPERIORITY||Odds Ratio (OR)|1.41||||0.04|TWO_SIDED|95.0|1.02|1.96||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.96|1.02|0.040
91730035|NCT03449147|183355552|SUPERIORITY||Odds Ratio (OR)|1.03||||0.872|TWO_SIDED|95.0|0.75|1.4||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.40|0.75|0.872
91730036|NCT03449147|183355552|SUPERIORITY||Odds Ratio (OR)|1.33||||0.082|TWO_SIDED|95.0|0.96|1.83||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.83|0.96|0.082
91730037|NCT03449147|183355553|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.96|1.83||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.83|0.96|
91698021|NCT03425396|183290688|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.0|||||TWO_SIDED|95.0|-27.4|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-27.4|
91698022|NCT03425396|183290688|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.6|||||TWO_SIDED|95.0|-19.6|7.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.4|-19.6|
91698023|NCT03425396|183290688|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
91698024|NCT03425396|183290689|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-14.3|11.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.2|-14.3|
91491618|NCT00674700|182855953|SUPERIORITY_OR_OTHER|||||||0.015||||||main effects= treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.015
91698025|NCT03425396|183290689|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.7|||||TWO_SIDED|95.0|-16.8|9.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.0|-16.8|
91491619|NCT00674700|182855954|SUPERIORITY_OR_OTHER|||||||0.0086|||||||ANCOVA|||||||0.0086
91491620|NCT00674700|182855954|SUPERIORITY_OR_OTHER|||||||0.0095|||||||ANCOVA|||||||0.0095
91698026|NCT03425396|183290689|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.3|12.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.3|-12.3|
91698027|NCT03425396|183290689|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
91698028|NCT03425396|183290690|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.0|||||TWO_SIDED|95.0|-22.5|16.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||16.8|-22.5|
91698029|NCT03425396|183290690|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-4.7|||||TWO_SIDED|95.0|-23.3|14.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.2|-23.3|
91698030|NCT03425396|183290690|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|5.7|||||TWO_SIDED|95.0|-13.0|22.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||22.6|-13.0|
91698031|NCT03425396|183290690|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
91698032|NCT03425396|183290691|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.7|||||TWO_SIDED|95.0|-10.0|13.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.4|-10.0|
91698033|NCT03425396|183290691|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-2.9|||||TWO_SIDED|95.0|-16.2|9.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.7|-16.2|
91698034|NCT03425396|183290691|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment Difference|7.7|||||TWO_SIDED|95.0|-0.3|18.5|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||18.5|-0.3|
91698035|NCT03425396|183290691|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatm,ent difference|7.7|||||TWO_SIDED|95.0|-34.9|20.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.6|-34.9|
91698036|NCT03425396|183290692|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.6|12.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.6|-12.6|
91698037|NCT03425396|183290692|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.7|||||TWO_SIDED|95.0|-16.3|10.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||10.2|-16.3|
91698038|NCT03425396|183290692|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.0|||||TWO_SIDED|95.0|-4.5|17.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||17.7|-4.5|
91698039|NCT03425396|183290692|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
91698040|NCT03425396|183290693|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.3|-27.3|
91698041|NCT03425396|183290693|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.6|||||TWO_SIDED|95.0|-29.2|8.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||8.6|-29.2|
91698042|NCT03425396|183290693|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|1.3|||||TWO_SIDED|95.0|-19.0|19.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.2|-19.0|
91698043|NCT03425396|183290693|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
91698044|NCT03425396|183290694|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.3|||||TWO_SIDED|95.0|-18.6|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-18.6|
91698045|NCT03425396|183290694|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.8|||||TWO_SIDED|95.0|-29.6|-0.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-0.6|-29.6|
91698046|NCT03425396|183290694|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.3|||||TWO_SIDED|95.0|-23.2|4.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.4|-23.2|
91698047|NCT03425396|183290694|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
91730038|NCT03449147|183355553|OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.08|2.09||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.09|1.08|
91730039|NCT03449147|183355554|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.69|0.93|
91730040|NCT03449147|183355554|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.31|2.39||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.39|1.31|
91730041|NCT03449147|183355555|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.14|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.05|1.14|
91730042|NCT03449147|183355555|OTHER||Odds Ratio (OR)|1.65||||||95.0|1.23|2.22||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.22|1.23|
91730043|NCT00954538|183355560|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91730044|NCT00954538|183355561|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|||||TWO_SIDED|90.0|-0.04|0.27|||Linear Fixed Effects Model||Difference = AD group value - HE group value|A 90% confidence interval was calculated for the group difference (AD - HE) using the model results. As prespecified by the analysis plan, if the lower bound of the 90% confidence interval is above 0, then the hypothesis that \[18F\]MK-3328 can discriminate between AD patients and cognitively normal elderly controls as measured by regional tracer uptake following single IV doses of \[18F\]MK-3328 is supported.||0.27|-0.04|
91730045|NCT01866150|183355579|SUPERIORITY_OR_OTHER||Treatment Difference|1.2||||0.8222|TWO_SIDED|95.0|-9.5|12.0|||Pearson's chi-squared|||A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||12.0|-9.5|0.8222
91730046|NCT01866150|183355580|SUPERIORITY_OR_OTHER||Treatment Difference|3.7||||0.4727|TWO_SIDED|95.0|-6.2|13.6|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.6|-6.2|0.4727
91730047|NCT01866150|183355580|SUPERIORITY_OR_OTHER||Treatment Difference|2.6||||0.6349|TWO_SIDED|95.0|-8.0|13.1|||Pearson's chi-squared|||Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.1|-8.0|0.6349
91730048|NCT01866150|183355581|SUPERIORITY_OR_OTHER||Slope|-0.9||||0.8769|TWO_SIDED|95.0|-12.1|10.4|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||10.4|-12.1|0.8769
91730049|NCT01866150|183355581|SUPERIORITY_OR_OTHER||Treatment Difference|3.4||||0.5649|TWO_SIDED|95.0|-8.2|15.0|||Pearson's chi-squared|||Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||15.0|-8.2|0.5649
91730050|NCT01866150|183355581|SUPERIORITY_OR_OTHER||Treatment Difference|9.9||||0.0556|TWO_SIDED|95.0|-0.3|20.2|||Pearson's chi-squared|||Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||20.2|-0.3|0.0556
91730051|NCT01866150|183355582|SUPERIORITY_OR_OTHER||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.152||0.5195|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.20|-0.40|0.5195
91730052|NCT01866150|183355582|SUPERIORITY_OR_OTHER||Treatment difference|-0.17|STANDARD_ERROR_OF_MEAN|0.149||0.242|TWO_SIDED|95.0|-0.47|0.12|||Mixed Models Analysis|||Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.12|-0.47|0.2420
91698048|NCT03425396|183290695|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-0.3|||||TWO_SIDED|95.0|-13.1|12.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.7|-13.1|
91491621|NCT00964860|182855968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05||0.001|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%. Units on the MGI Scale.|||||0.001
91491622|NCT00964860|182855969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.004|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%|||||0.004
91491623|NCT02585960|182855970|SUPERIORITY||Gaussian Statistic estimate|1.96||||0.0545|TWO_SIDED|95.0|-0.038|3.958|||Chi-squared||Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.|The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.||3.958|-0.038|0.0545
91491624|NCT01847274|182855998|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.173|0.41||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.410|0.173|<0.0001
91491625|NCT01847274|182855999|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.243|0.586||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.586|0.243|<0.0001
91491626|NCT01847274|182856000|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.338|0.607||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.607|0.338|<0.0001
91491627|NCT01847274|182856001|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.412|0.783||Two-sided p-value|Log Rank|||||0.783|0.412|0.0005
91491628|NCT01847274|182856002|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.454|0.74||Two-sided P-value.|Log Rank|||||0.740|0.454|<0.0001
91491629|NCT01847274|182856003|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.268|0.561||Two-sided P-value.|Log Rank|||||0.561|0.268|<0.0001
91491630|NCT01847274|182856004|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.428|0.727||Two-sided P-value.|Log Rank|||||0.727|0.428|<0.0001
91698049|NCT03425396|183290695|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.8|||||TWO_SIDED|95.0|-20.7|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-20.7|
91698050|NCT03425396|183290695|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.1|||||TWO_SIDED|95.0|-15.1|11.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.6|-15.1|
91698051|NCT03425396|183290695|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
91698052|NCT03425396|183290696|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||13.3|-27.3|
91698053|NCT03425396|183290696|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.5|||||TWO_SIDED|95.0|-32.4|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||5.9|-32.4|
91491631|NCT01847274|182856005|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0302|TWO_SIDED|95.0|0.5|0.968||Two-sided P-value.|Log Rank|||||0.968|0.500|0.0302
91491632|NCT01847274|182856006|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0748|TWO_SIDED|95.0|0.627|1.022||Two-sided P-value.|Log Rank|||||1.022|0.627|0.0748
91491633|NCT01847274|182856007|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.606|1.198||Two-sided P-value.|Log Rank|||||1.198|0.606|0.3580
91491634|NCT01847274|182856008|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6868|TWO_SIDED|95.0|0.813|1.369||Two-sided P-value.|Log Rank|||||1.369|0.813|0.6868
91491635|NCT01847274|182856009|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0061|TWO_SIDED|95.0|0.451|0.878||Two-sided P-value.|Log Rank|||||0.878|0.451|0.0061
91491636|NCT01847274|182856010|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1674|TWO_SIDED|95.0|0.654|1.077||Two-sided P-value.|Log Rank|||||1.077|0.654|0.1674
91491637|NCT01847274|182856027|SUPERIORITY|||||||0.7969|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.7969
91491638|NCT01847274|182856027|SUPERIORITY|||||||0.8794|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.8794
91491639|NCT01847274|182856028|SUPERIORITY|||||||0.2399|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.2399
91491640|NCT01847274|182856028|SUPERIORITY|||||||0.4584|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4584
91491641|NCT01847274|182856029|SUPERIORITY|||||||0.8566|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8566
91491642|NCT01847274|182856029|SUPERIORITY|||||||0.4705|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4705
91491643|NCT01847274|182856030|SUPERIORITY|||||||0.8521|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8521
91491644|NCT01847274|182856030|SUPERIORITY|||||||0.9923|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9923
91698054|NCT03425396|183290696|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.0|||||TWO_SIDED|95.0|-25.7|15.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||15.6|-25.7|
91698055|NCT03425396|183290696|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||28.9|-40.4|
91698056|NCT03425396|183290697|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-21.3|||||TWO_SIDED|95.0|-44.1|-1.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-1.0|-44.1|
91698057|NCT03425396|183290697|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.9|||||TWO_SIDED|95.0|-32.2|4.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.9|-32.2|
91491645|NCT01847274|182856031|SUPERIORITY|||||||0.9997|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9997
91698058|NCT03425396|183290697|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-19.4|||||TWO_SIDED|95.0|-43.1|1.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.1|-43.1|
91698059|NCT03425396|183290697|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.7|||||TWO_SIDED|95.0|-43.8|23.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||23.2|-43.8|
91698060|NCT03425396|183290698|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.7|||||TWO_SIDED|95.0|-37.2|3.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||3.1|-37.2|
91698061|NCT03425396|183290698|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-15.9|||||TWO_SIDED|95.0|-34.3|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-34.3|
91730053|NCT01866150|183355582|SUPERIORITY_OR_OTHER||Treatment difference|-0.15|STANDARD_ERROR_OF_MEAN|0.154||0.3264|TWO_SIDED|95.0|-0.45|0.15|||Mixed Models Analysis|||Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.15|-0.45|0.3264
91698062|NCT03425396|183290698|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-23.8|||||TWO_SIDED|95.0|-46.9|-4.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-4.3|-46.9|
91698063|NCT03425396|183290698|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.4|||||TWO_SIDED|95.0|-48.5|19.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.7|-48.5|
91730054|NCT01866150|183355584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81||||0.0237|TWO_SIDED|95.0|-16.44|-1.18|||General Linear Model|||Analysis was performed using a general linear model with cohort as a factor.||-1.18|-16.44|0.0237
91730055|NCT00600704|183355589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.379|STANDARD_DEVIATION|0.096|<|0.05|TWO_SIDED|95.0|0.189|0.569|||t-test, 2 sided|||Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.||0.569|0.189|<0.05
91491646|NCT01847274|182856031|SUPERIORITY|||||||0.3518|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.3518
91491647|NCT01847274|182856032|SUPERIORITY|||||||0.9367|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9367
91491648|NCT01847274|182856032|SUPERIORITY|||||||0.2502|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2502
91491649|NCT01847274|182856033|SUPERIORITY|||||||0.5037|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5037
91491650|NCT01847274|182856033|SUPERIORITY|||||||0.164|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.1640
91491651|NCT01847274|182856034|SUPERIORITY|||||||0.9599|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9599
91491652|NCT01847274|182856034|SUPERIORITY|||||||0.247|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2470
91491653|NCT01847274|182856035|SUPERIORITY|||||||0.5921|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5921
91491654|NCT01847274|182856035|SUPERIORITY|||||||0.7459|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.7459
91491655|NCT01847274|182856036|SUPERIORITY|||||||0.0259|||||||Pearson's Chi-squared test|||||||0.0259
91491656|NCT01847274|182856036|SUPERIORITY|||||||0.2798|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2798
91698064|NCT03425396|183290699|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-20.7|||||TWO_SIDED|95.0|-45.1|6.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||6.0|-45.1|
91698065|NCT03425396|183290699|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-17.8|||||TWO_SIDED|95.0|-40.2|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||5.9|-40.2|
91698066|NCT03425396|183290699|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.4|||||TWO_SIDED|95.0|-36.8|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-36.8|
91698067|NCT03425396|183290699|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.3|||||TWO_SIDED|95.0|-47.0|33.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||33.2|-47.0|
91698068|NCT03425396|183290700|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.6|||||TWO_SIDED|95.0|-40.4|13.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.2|-40.4|
91730056|NCT00600704|183355589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.797|STANDARD_ERROR_OF_MEAN|0.168|<|0.05|TWO_SIDED|95.0|0.465|1.129|||Regression, Linear||The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.|Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.||1.129|0.465|<0.05
91730057|NCT01644331|183355616|SUPERIORITY_OR_OTHER|||||||0.315|||||||Chi-squared|||||||0.315
91491657|NCT01847274|182856043|SUPERIORITY||Ratio of Least square mean|1.1|||||TWO_SIDED|90.0|0.997|1.216||||||||1.216|0.997|
91491658|NCT01847274|182856044|SUPERIORITY||Ratio of Least square mean|1.068|||||TWO_SIDED|90.0|0.978|1.166||||||||1.166|0.978|
91491659|NCT01847274|182856045|SUPERIORITY||Ratio of Least square mean|0.785|||||TWO_SIDED|90.0|0.695|0.886||||||||0.886|0.695|
91491660|NCT00724932|182856061|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|3.4|||<|0.0001|TWO_SIDED|95.0|2.8|4.1||Testing was performed using a two-sided test at the 0.05 significance level. There was only one primary comparison, therefore no adjustment for multiplicity was required.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.9 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a two-way analysis of variance (ANOVA) model adjusted for treatment group and trial site.||4.1|2.8|<0.0001
91698069|NCT03425396|183290700|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.6|||||TWO_SIDED|95.0|-32.7|14.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.6|-32.7|
91491661|NCT00724932|182856062|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.1|2.8||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.7 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.7 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||2.8|2.1|<0.0001
91698070|NCT03425396|183290700|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.9|||||TWO_SIDED|95.0|-38.2|14.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.9|-38.2|
91698071|NCT03425396|183290700|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.4|||||TWO_SIDED|95.0|-50.3|30.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||30.9|-50.3|
91698072|NCT00601172|183290705|SUPERIORITY_OR_OTHER||difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
91730058|NCT01644331|183355617|SUPERIORITY_OR_OTHER||Slope|0.19||||0.021|TWO_SIDED|95.0|0.03|0.34|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.34|0.03|0.021
91730059|NCT01644331|183355618|SUPERIORITY_OR_OTHER||Slope|0.99||||0.43|TWO_SIDED|95.0|-1.47|3.44|||Mixed Models Analysis|||This a repeated measure analysis so all rows (visits) are taken into account.||3.44|-1.47|0.430
91491662|NCT00724932|182856070|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.5|3.4||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.8 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.8 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||3.4|2.5|<0.0001
91491663|NCT02340975|182856144|OTHER|Comparison|Mean Difference (Net)|11.1||||0.2376|TWO_SIDED|95.0|-0.7|23.0|||Fisher Exact|||||23.0|-0.7|0.2376
91698073|NCT00601172|183290706|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.4771|TWO_SIDED|95.0|-1.8|3.8||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||3.8|-1.8|0.4771
91491664|NCT02340975|182856144|OTHER|Comparison|Median Difference (Net)|2.8||||1|TWO_SIDED|95.0|-16.8|22.4|||Fisher Exact|||||22.4|-16.8|1.0000
91491665|NCT03948581|182856175|EQUIVALENCE|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with group, treatment, and injection site as fixed effects and weight as a continuous covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9807|||||TWO_SIDED|90.0|0.9011|1.0675||||||||1.0675|0.9011|
91491666|NCT03948581|182856176|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9981|||||TWO_SIDED|90.0|0.9223|1.0801||||||||1.0801|0.9223|
91491667|NCT03948581|182856177|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0038|||||TWO_SIDED|90.0|0.9401|1.0719||||||||1.0719|0.9401|
91491668|NCT02498132|182856193|OTHER|A generalized estimating equation (GEE) model assuming a normal distribution, identity link function, and exchangeable correlation matrix was used to examine the interaction between time and treatment condition on BDI-II depressive symptoms adjusting for the main effects of baseline depressive symptoms, time, and treatment condition.|||||<|0.05|||||||Chi-squared|||||||<.05
91491669|NCT00730405|182856206|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491670|NCT00730405|182856206|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491671|NCT00730405|182856206|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491672|NCT00730405|182856206|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491673|NCT00730405|182856207|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91698074|NCT00601172|183290707|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6|||Pooled Z test|p-value based on normal approximation to the binomial using a pooled Z test.|The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
91491674|NCT00730405|182856207|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491675|NCT00730405|182856207|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491676|NCT00730405|182856207|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491677|NCT00730405|182856208|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491678|NCT00730405|182856208|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491679|NCT00730405|182856208|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491680|NCT00730405|182856208|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491681|NCT00730405|182856209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491682|NCT00730405|182856209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491683|NCT00730405|182856209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491684|NCT00730405|182856209|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491685|NCT00730405|182856210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
91491686|NCT00730405|182856210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.71|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
91491687|NCT00730405|182856210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.44|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
91491688|NCT00730405|182856210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.22|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|||||||ANOVA|||||||<0.001
91491689|NCT00730405|182856211|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491690|NCT00730405|182856211|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491691|NCT00730405|182856211|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491692|NCT00730405|182856211|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91491693|NCT00963937|182856212|SUPERIORITY_OR_OTHER||Percent Difference|-7.49||||0.345|TWO_SIDED|95.0|-23.02|8.04||Multiplicity was not considered because the primary analysis included a single statistical comparison.|Chi-squared||Percent difference = sumatriptan pooled group minus the placebo group|||8.04|-23.02|0.345
91491694|NCT00181155|182856246|SUPERIORITY_OR_OTHER||||||<|0.007||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.007
91491695|NCT00181155|182856247|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.02
91698075|NCT00601172|183290708|SUPERIORITY_OR_OTHER||Treatment difference (%)|6.0||||0.0317|TWO_SIDED|95.0|0.5|11.5||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test|||Placebo vs Casopitant 90 mg||11.5|0.5|0.0317
91698076|NCT00601172|183290709|SUPERIORITY_OR_OTHER|||||||0.056|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-120 hours)||||0.0560
91698077|NCT00601172|183290709|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-24 hours)||||0.0443
91698078|NCT00601172|183290709|SUPERIORITY_OR_OTHER|||||||0.1709|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (24-120 hours)||||0.1709
91698079|NCT00601172|183290710|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||2.3|-5.9|0.3986
91698080|NCT00601172|183290710|SUPERIORITY_OR_OTHER||Treatment difference (%)|-0.9||||0.3545|TWO_SIDED|95.0|-2.7|1.0|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.0|-2.7|0.3545
91698081|NCT00601172|183290710|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||2.3|-5.9|0.3986
91698082|NCT00601172|183290711|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||3.5|-5.4|0.6795
91698083|NCT00601172|183290711|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.4507|TWO_SIDED|95.0|-3.1|1.4|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.4|-3.1|0.4507
91698084|NCT00601172|183290711|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||3.5|-5.4|0.6795
91698085|NCT00601172|183290712|SUPERIORITY_OR_OTHER||Difference in percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||8.0|-3.8|0.4846
91698086|NCT00601172|183290712|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.8||||0.6101|TWO_SIDED|95.0|-2.3|3.9|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||3.9|-2.3|0.6101
91698087|NCT00601172|183290712|SUPERIORITY_OR_OTHER||Percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||8.0|-3.8|0.4846
91698088|NCT00601172|183290713|SUPERIORITY_OR_OTHER||Difference in percentage of participants|3.8||||0.1356|TWO_SIDED|95.0|-1.2|8.9|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||8.9|-1.2|0.1356
91491696|NCT02572401|182856248|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.21|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.21|.59|<.05
91491697|NCT02572401|182856248|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED|95.0|0.69|1.42|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.42|0.69|<.05
91491698|NCT02572401|182856248|SUPERIORITY||Risk Ratio (RR)|0.72|||<|0.05|TWO_SIDED|95.0|0.35|1.49|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.49|.35|<.05
91528429|NCT00708305|182932215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.11||||0.0023|TWO_SIDED|95.0|0.04|0.22||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.22|0.04|0.0023
91528430|NCT00708305|182932215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.34|||<|0.0001|TWO_SIDED|95.0|0.22|0.51||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.51|0.22|<0.0001
91698089|NCT00601172|183290713|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||15.4|0.9|0.0280
91698090|NCT00601172|183290713|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||15.4|0.9|0.0280
91698091|NCT00601172|183290714|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||5.5|-7.3|0.7799
91698092|NCT00601172|183290714|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.5||||0.7883|TWO_SIDED|95.0|-3.2|4.2|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||4.2|-3.2|0.7883
91698093|NCT00601172|183290714|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||5.5|-7.3|0.7799
91698094|NCT00601172|183290715|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||0.0|-15|0.0507
91698095|NCT00601172|183290715|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-4.7||||0.08|TWO_SIDED|95.0|-9.9|0.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||0.5|-9.9|0.0800
91698096|NCT00601172|183290715|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||0.0|-15|0.0507
91698097|NCT00601172|183290716|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-2.6|||||TWO_SIDED|97.5|-9.9|4.7|||||The parameter estimated was difference in percentage of participants with response.|Nausea Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||4.7|-9.9|
91698098|NCT00601172|183290716|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.7||||||97.5|-5.2|6.6|||||The parameter estimated was difference in percentage of participants with response.|Vomiting Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||6.6|-5.2|
91698099|NCT00601172|183290717|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-120 hours) in Cycle 1||||0.1572
91698100|NCT00601172|183290717|SUPERIORITY_OR_OTHER|||||||0.2908|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-24 hours) in Cycle 1||||0.2908
91698101|NCT00601172|183290717|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (24-120 hours) in Cycle 1||||0.1572
91491699|NCT02572401|182856249|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.92|1.18|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.18|0.92|<.05
91491700|NCT02572401|182856249|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.9|1.16|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.16|0.90|<.05
91528431|NCT00708305|182932215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.12|0.25||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.25|0.12|<0.0001
91698102|NCT05896527|183290807|SUPERIORITY||Odds Ratio (OR)|0.46||||0.4839|TWO_SIDED|95.0|0.07|2.37|||Fisher Exact||DC-806 200 mg BID compared to Placebo|||2.37|0.07|0.4839
91698103|NCT05896527|183290807|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4111|TWO_SIDED|95.0|0.51|6.49|||Fisher Exact||DC-806 400 mg BID compared to Placebo|||6.49|0.51|0.4111
91698104|NCT05896527|183290807|SUPERIORITY||Odds Ratio (OR)|1.3||||0.7744|TWO_SIDED|95.0|0.36|4.99|||Fisher Exact||DC-806 600 mg QD compared to Placebo|||4.99|0.36|0.7744
91698105|NCT05896527|183290807|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0164|TWO_SIDED|95.0|1.15|12.37|||Fisher Exact||DC-806 800 mg BID compared to Placebo|||12.37|1.15|0.0164
91698106|NCT01279070|183290809|SUPERIORITY_OR_OTHER||Effect size|0.43|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML.An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 16 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
91698107|NCT01279070|183290810|SUPERIORITY_OR_OTHER||Effect Size|0.42|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood(REML).An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 40 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
91698108|NCT01279070|183290811|SUPERIORITY_OR_OTHER||Effect Size|0.33|||<|0.05|TWO_SIDED|95.0|0.06|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.06|<0.05
91698109|NCT01279070|183290812|SUPERIORITY_OR_OTHER||Effect Size|0.35|||<|0.05|TWO_SIDED|95.0|0.09|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.09|<0.05
91698110|NCT01279070|183290813|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
91698111|NCT01279070|183290814|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups, standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR) assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
91698112|NCT01683266|183290905|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.098|0.185||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.185|-0.098|
91698113|NCT01683266|183290908|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.322|||TWO_SIDED|95.0|-0.982|0.287||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.||0.287|-0.982|
91698114|NCT00090220|183290934|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|88.7||||||95.0|78.1|94.8|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||94.8|78.1|
91698115|NCT00090220|183290960|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|94.8||||||95.0|79.9|99.4|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||99.4|79.9|
91698116|NCT00090220|183290968|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|84.7||||||95.0|67.5|93.7|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||93.7|67.5|
91730060|NCT01644331|183355619|SUPERIORITY_OR_OTHER||Slope|-493.21||||0.157|TWO_SIDED|95.0|-1176.96|190.55|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||190.55|-1176.96|0.157
91698117|NCT00823043|183290983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<.001
91698118|NCT00823043|183290984|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
91698119|NCT00823043|183290985|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
91698120|NCT00823043|183290986|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
91698121|NCT02651155|183290987|SUPERIORITY_OR_OTHER||Median Values of CI|1.0||||0.003|TWO_SIDED|95.0|0.1|1.0|||Van Elteren Test|SBM was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|CI was estimated by inverting the hypothesis test.|||1.0|0.1|0.003
91698122|NCT00526669|183291092|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: TS|Wilcoxon signed rank test|||||||0.10
91730061|NCT01644331|183355620|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||This is a repeated measures analysis so all rows (visits) are taken into account.||||0.206
91730062|NCT01644331|183355621|SUPERIORITY_OR_OTHER||Kaplan Meier|0.98||||0.334|TWO_SIDED|95.0|0.96|0.99|||Log Rank|||||0.99|0.96|0.334
91698123|NCT00526669|183291092|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||Biomarker: DPD|Wilcoxon signed rank test|||||||0.097
91730063|NCT01644331|183355622|SUPERIORITY_OR_OTHER|||||||0.148|||||||Chi-squared|||||||0.148
91730064|NCT01644331|183355623|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||||||0.334
91730065|NCT01644331|183355624|SUPERIORITY_OR_OTHER||Slope|-0.67||||0.241|TWO_SIDED|95.0|-1.79|0.45|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.45|-1.79|0.241
91730066|NCT01644331|183355625|SUPERIORITY_OR_OTHER||Slope|0.28||||0.303|TWO_SIDED|95.0|-0.26|0.82|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.82|-0.26|0.303
91730067|NCT01644331|183355626|SUPERIORITY_OR_OTHER|||||||0.471||||||24 hours|Chi-squared|||||||0.471
91730068|NCT01644331|183355626|SUPERIORITY_OR_OTHER|||||||0.585||||||48 hrs|Chi-squared|||||||0.585
91730069|NCT01644331|183355626|SUPERIORITY_OR_OTHER|||||||0.12||||||72 hrs|Chi-squared|||||||0.120
91730070|NCT01644331|183355627|SUPERIORITY_OR_OTHER|||||||0.037|||||||Chi-squared|||||||0.037
91698124|NCT00526669|183291092|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: EGFR/HER1|Wilcoxon signed rank test|||||||0.10
91698125|NCT00526669|183291092|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Biomarker: HER2|Wilcoxon signed rank test|||||||0.26
91698126|NCT00526669|183291092|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||Biomarker: HER3|Wilcoxon signed rank test|||||||0.38
91698127|NCT00526669|183291093|SUPERIORITY_OR_OTHER||percentage of participants|17.9|||||TWO_SIDED|95.0|9.6|29.2|||||The estimated value represents the percentage of participants with complete response or partial response.|||29.2|9.6|
91698128|NCT00526669|183291094|SUPERIORITY_OR_OTHER||percentage of participants|29.0|||||TWO_SIDED|95.0|17.9|40.3|||||The estimated value reflects the percentage of participants who achieved progression-free survival.|||40.3|17.9|
91698129|NCT04259424|183291136|OTHER|||||||0.15|||||||t-test, 2 sided|||||||.15
91698130|NCT01489254|183291171|NON_INFERIORITY_OR_EQUIVALENCE|To conclude study sensitivity the combined active treatment groups Glatiramer 20 mg and Copaxone 20 mg needed to be superior to placebo.|Ratio (or Ratio of estimated means)|0.488|||||TWO_SIDED|95.0|0.365|0.651|||||Ratio of combined Glatiramer 20 mg + Copaxone 20 mg to placebo and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function. To assess study sensitivity, data of the active treatment groups and placebo were included in the model, resulting in the ratios and 95% CIs for the combined Glatiramer 20 mg and Copaxone 20 mg treatment group and the individual treatments over placebo.||0.651|0.365|
91730071|NCT01644331|183355628|SUPERIORITY_OR_OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
91730072|NCT01644331|183355629|SUPERIORITY_OR_OTHER||Kaplan Meier|0.26||||0.709|TWO_SIDED|95.0|0.21|0.32|||Log Rank|||||0.32|0.21|0.709
91759097|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0728|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0728
91759098|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0005
91698131|NCT01489254|183291171|NON_INFERIORITY_OR_EQUIVALENCE|To conclude equivalence between Glatiramer 20 mg and Copaxone 20 mg, efficacy in the combined active treatment groups needed to be superior to placebo (confirming study sensitivity) and the 2-sided 95% CI for the estimated ratio of Glatiramer 20 mg to Copaxone 20 mg needed to be fully enclosed in the prespecified equivalence margin (0.727 - 1.375).|Ratio (or Ratio of estimated means)|1.095|||||TWO_SIDED|95.0|0.883|1.36|||||Ratio of Glatiramer 20 mg to Copaxone 20 mg and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function including Glatiramer 20 mg and Copaxone 20 mg treatment groups to assess study equivalence.||1.360|0.883|
91698132|NCT01981954|183291172|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 MCC Analysis||||<0.001
91698133|NCT01981954|183291174|OTHER|||||||0.003||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline=0.|t-test, 2 sided|||Week 24 Analysis||||0.003
91698134|NCT01981954|183291175|OTHER|||||||0.744||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.744
91698135|NCT01981954|183291176|OTHER|||||||0.352||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.352
91730073|NCT03829514|183355630|OTHER|||||||0.05|||||||t-test, 2 sided|Signal intensity data were loess normalized and normalized data were used to perform a limma t-test with empirical Bayes smoothing to standard errors|||Proteins were identified and quantified using EncyclopeDIA and visualized with Scaffold DIA using 1% false discovery thresholds at both the protein and peptide level. Protein exclusive intensity values were assessed for quality using an in-house ProteiNorm app, a tool for systematic evaluation of normalization methods, imputation of missing values and comparisons of multiple differential abundance methods . Cyclic loess normalization. The normalized data were used to perform statistical analysis using linear models for microarray data (limma) with empirical Bayes (eBayes) smoothing to the standard errors. Proteins with p-value \< 0.05 were considered significant.|||0.05
91730074|NCT01339091|183355631|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|1.5|||||TWO_SIDED|95.0|-4.6|7.9|||||Confidence intervals were adjusted for fever at baseline|||7.9|-4.6|
91730075|NCT03992872|183355661|SUPERIORITY|The significance of the difference between groups in seroconversion rates was assessed using a Fisher's exact test. The percentage who seroconverted in each group was presented along with its 95% CI calculated using the Wilson method. The Newcombe method was use to estimate the 95% confidence interval for the difference between groups in the percentage of subjects who seroconverted.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-11.4|11.4|||Fisher Exact|||||11.4|-11.4|1
91730076|NCT03992872|183355662|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.2|||||TWO_SIDED|95.0||||P- value = NE (Not estimable due to lack of response; all baseline values in this group were \<LOD and imputed as LOD/2, or 7.5)||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
91759099|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0005
91759100|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0078
91759101|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0078
91759102|NCT01846741|183411301|SUPERIORITY_OR_OTHER|||||||0.0273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0273
91759103|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0192|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0192
91759104|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.8069|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.8069
91759105|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.2416
91698136|NCT01981954|183291177|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
91698137|NCT01981954|183291178|OTHER|||||||0.177||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.177
91759106|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.1111|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1111
91759107|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0014
91759108|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.3247|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3247
91491701|NCT02572401|182856249|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.86|1.42|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.42|0.86|<.05
91491702|NCT02572401|182856250|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.89|1.24|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.24|0.89|<.05
91491703|NCT02572401|182856250|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.94|1.3|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|The numerator is the treatment.|1.30|0.94|<.05
91491704|NCT02572401|182856250|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.76|1.47|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.47|0.76|<.05
91698138|NCT01981954|183291179|OTHER|||||||0.025||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analyis||||0.025
91698139|NCT01981954|183291180|OTHER|||||||0.05||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.050
91698140|NCT01981954|183291181|OTHER|||||||0.567||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.567
91491705|NCT02572401|182856251|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.73|1.48|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.48|0.73|<.05
91698141|NCT01981954|183291182|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
91491706|NCT02572401|182856251|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.71|1.45|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.45|0.71|<.05
91698142|NCT01981954|183291183|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
91698143|NCT01981954|183291184|OTHER|||||||0.004||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.004
91698144|NCT01981954|183291185|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
91698145|NCT01981954|183291186|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
91698146|NCT01981954|183291203|OTHER|||||||0.688||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.688
91698147|NCT01981954|183291204|OTHER|||||||0.61||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.610
91698148|NCT01981954|183291205|OTHER|||||||0.562||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.562
91698149|NCT01981954|183291206|OTHER|||||||0.657||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.657
91698150|NCT01981954|183291207|OTHER|||||||0.631||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.631
91698151|NCT01981954|183291208|OTHER|||||||0.41||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.410
91698152|NCT01981954|183291209|OTHER|||||||0.94||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.940
91698153|NCT01981954|183291210|OTHER|||||||1||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||1.000
91698154|NCT01981954|183291211|OTHER|||||||0.575||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|t-test, 2 sided|||Week 24 Analysis||||0.575
91698155|NCT01981954|183291212|OTHER|||||||0.031||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.031
91698156|NCT01981954|183291213|OTHER|||||||0.721||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.721
91730077|NCT03992872|183355662|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|3.11||||0.0019|TWO_SIDED|95.0|1.55|6.23|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 8: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||6.23|1.55|0.0019
91730078|NCT03992872|183355662|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6223|TWO_SIDED|95.0|0.54|1.46|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.46|0.54|0.6223
91491707|NCT02572401|182856251|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.5|2.08|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||2.08|.50|<.05
91491708|NCT02572401|182856252|SUPERIORITY||Mean Difference (Final Values)|0.001|||<|0.05|TWO_SIDED|95.0|-0.078|0.08|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||0.080|-0.078|<.05
91491709|NCT02572401|182856252|SUPERIORITY||Mean Difference (Final Values)|-0.003|||<|0.05|TWO_SIDED|95.0|-0.082|0.076|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||0.076|-0.082|<.05
91513248|NCT02710630|182898017|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|59.01|STANDARD_DEVIATION|73.4|||TWO_SIDED|90.0|45.255|76.955|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.955|45.255|
91698157|NCT04016779|183291219|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.28||0.004|TWO_SIDED|95.0|-6.2|-1.2|||Mixed Model for Repeated Measures|||||-1.2|-6.2|0.0040
91698158|NCT04016779|183291220|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Model for Repeated Measures|||||-0.2|-0.7|0.0023
91698159|NCT04016779|183291221|SUPERIORITY||Difference in percentage of responders|5.6||||0.303|TWO_SIDED|95.0|-5.0|16.1|||Pearson's chi-squared test|||||16.1|-5.0|0.3030
91698160|NCT04016779|183291222|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0076|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-0.6|0.0076
91698161|NCT04016779|183291223|SUPERIORITY||Difference in percentage of responders|10.7||||0.0744|TWO_SIDED|95.0|-1.0|22.1|||Pearson's chi-squared test|||||22.1|-1.0|0.0744
91698162|NCT04016779|183291224|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.9205|TWO_SIDED|95.0|-0.9|0.8|||Mixed Model for Repeated Measures|||||0.8|-0.9|0.9205
91698163|NCT04016779|183291225|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.77||0.0015|TWO_SIDED|95.0|-4.0|-0.9|||Mixed Model for Repeated Measures|||||-0.9|-4.0|0.0015
91698164|NCT04016779|183291226|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.038|TWO_SIDED|95.0|-2.7|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-2.7|0.0380
91698165|NCT04016779|183291227|SUPERIORITY||Difference in percentage of responders|12.4||||0.0395|TWO_SIDED|95.0|0.6|23.8|||Pearson's chi-squared test|||||23.8|0.6|0.0395
91698166|NCT04016779|183291228|SUPERIORITY||Difference in percentage of responders|6.4||||0.2736|TWO_SIDED|95.0|-5.0|17.5|||Pearson's chi-squared test|||||17.5|-5.0|0.2736
91698167|NCT04016779|183291229|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.22||0.0468|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|||||0.0|-4.8|0.0468
91698168|NCT04016779|183291230|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.04||0.4462|TWO_SIDED|95.0|-2.8|1.3|||ANCOVA|||||1.3|-2.8|0.4462
91698169|NCT04016779|183291231|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.29||0.01|TWO_SIDED|95.0|-5.9|-0.8|||ANCOVA|||||-0.8|-5.9|0.0100
91698170|NCT04016779|183291232|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.16||0.2186|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|||||0.9|-3.7|0.2186
91698171|NCT04016779|183291233|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0344|TWO_SIDED|95.0|-4.5|-0.2|||ANCOVA|||||-0.2|-4.5|0.0344
91698172|NCT04016779|183291234|SUPERIORITY||Least Square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.99||0.368|TWO_SIDED|95.0|-1.1|2.8|||ANCOVA|||||2.8|-1.1|0.3680
91698173|NCT04016779|183291235|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6361|TWO_SIDED|95.0|-2.7|1.6|||ANCOVA|||||1.6|-2.7|0.6361
91698174|NCT04016779|183291236|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.1708|TWO_SIDED|95.0|-4.0|0.7|||ANCOVA|||||0.7|-4.0|0.1708
91698175|NCT04016779|183291237|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.3||0.0094|TWO_SIDED|95.0|-6.0|-0.8|||ANCOVA|||||-0.8|-6.0|0.0094
91698176|NCT04016779|183291238|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.34||0.0104|TWO_SIDED|95.0|-6.1|-0.8|||ANCOVA|||||-0.8|-6.1|0.0104
91698177|NCT04016779|183291239|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.13||0.0178|TWO_SIDED|95.0|-4.9|-0.5|||ANCOVA|||||-0.5|-4.9|0.0178
91698178|NCT04016779|183291240|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.34||0.0187|TWO_SIDED|95.0|-5.8|-0.5|||ANCOVA|||||-0.5|-5.8|0.0187
91698179|NCT00979875|183291241|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.08|||<|0.0001|TWO_SIDED|90.0|1.7|2.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||2.55|1.70|<0.0001
91698180|NCT00979875|183291241|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|5.26|||<|0.0001|TWO_SIDED|90.0|3.88|7.12||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||7.12|3.88|<0.0001
91491710|NCT02572401|182856252|SUPERIORITY||Mean Difference (Final Values)|-0.009|||<|0.05|TWO_SIDED|95.0|-0.167|0.149|||Regression, Linear|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.||The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||0.149|-0.167|<.05
91491711|NCT01323959|182856253|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|96.8|||||TWO_SIDED|95.0|89.0|99.6|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|"The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing."||99.6|89|
91698181|NCT00979875|183291241|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|4.14|||<|0.0001|TWO_SIDED|90.0|3.05|5.6||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||5.60|3.05|<0.0001
91698182|NCT00979875|183291242|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-38.93|||<|0.0001|TWO_SIDED|90.0|-53.31|-24.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-24.55|-53.31|<0.0001
91698183|NCT00979875|183291242|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-26.43||||0.0032|TWO_SIDED|90.0|-40.81|-12.05||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-12.05|-40.81|0.0032
91698184|NCT00979875|183291242|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-42.14|||<|0.0001|TWO_SIDED|90.0|-56.53|-27.76||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-27.76|-56.53|<0.0001
91698185|NCT01945970|183291247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.36|TWO_SIDED|95.0|-1.09|0.4|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.40|-1.09|0.36
91698186|NCT01945970|183291248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.18|TWO_SIDED|95.0|-0.24|1.28|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.28|-0.24|0.18
91759109|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0826
91698187|NCT01945970|183291249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.014|TWO_SIDED|95.0|-1.59|-0.19|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||-0.19|-1.59|0.014
91759110|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1040
91759111|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0094
91759112|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.5874|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.5874
91759113|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.1508|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1508
91759114|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.0136
91759115|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0015
91513249|NCT02710630|182898017|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.21|STANDARD_DEVIATION|55.7|||TWO_SIDED|90.0|87.698|133.53|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.530|87.698|
91698188|NCT01945970|183291250|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.49||||0.22|TWO_SIDED|95.0|-1.3|0.31|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.31|-1.30|0.22
91698189|NCT01945970|183291251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.09|TWO_SIDED|95.0|-0.11|1.53|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.53|-0.11|0.09
91513250|NCT02710630|182898017|SUPERIORITY_OR_OTHER||Ratio|110.21|STANDARD_DEVIATION|41.1|||TWO_SIDED|90.0|93.939|129.297|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.297|93.939|
91513251|NCT02710630|182898018|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|99.569|140.579|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||140.579|99.569|
91513252|NCT02710630|182898018|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|57.49|STANDARD_DEVIATION|132.3|||TWO_SIDED|90.0|38.502|85.837|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||85.837|38.502|
91513253|NCT02710630|182898018|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|61.94|STANDARD_DEVIATION|69.0|||TWO_SIDED|90.0|48.13|79.72|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||79.720|48.130|
91698190|NCT01945970|183291252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.32|TWO_SIDED|95.0|-1.13|0.37|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.37|-1.13|0.32
91698191|NCT01945970|183291253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.89||||0.14|TWO_SIDED|95.0|-0.61|4.39|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||4.39|-0.61|0.14
91698192|NCT01945970|183291254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.41|1.62|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||1.62|-2.41|0.69
91698193|NCT01945970|183291255|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.44||||0.72|TWO_SIDED|95.0|-2.06|2.95|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.95|-2.06|0.72
91698194|NCT01945970|183291256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.39|TWO_SIDED|95.0|-1.15|2.88|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.88|-1.15|0.39
91698195|NCT01945970|183291257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.74|TWO_SIDED|95.0|-1.75|1.24|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.24|-1.75|0.74
91698196|NCT01945970|183291258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.41|TWO_SIDED|95.0|-2.12|0.88|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.88|-2.12|0.41
91698197|NCT01945970|183291259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.74|TWO_SIDED|95.0|-1.11|1.54|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects||1.54|-1.11|0.74
91698198|NCT01945970|183291260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.66|TWO_SIDED|95.0|-1.84|1.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.17|-1.84|0.66
91698199|NCT01945970|183291261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|95.0|-2.7|0.3|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.30|-2.70|0.11
91698200|NCT01945970|183291262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.55|TWO_SIDED|95.0|-0.93|1.73|||Mixed Models Analysis||Effect of positive control adjusted for placebo|||1.73|-0.93|0.55
91698201|NCT02738879|183291263|NON_INFERIORITY|Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.|Between Group Difference in the LSM|-0.46|||||TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM||-0.34|-0.58|
91698202|NCT02738879|183291263|SUPERIORITY|Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.|Between Group Difference in the LSM|-0.46|||<|0.001|TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-0.34|-0.58|< 0.001
91698203|NCT02738879|183291264|SUPERIORITY||Event Rate Ratio|0.73|||=|0.039|TWO_SIDED|95.0|0.54|0.98|||Negative Binomial Model|||Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.98|0.54|= 0.039
91698204|NCT02738879|183291265|OTHER|95% CI|Between Group Difference in Percentages|-0.3|||||TWO_SIDED|95.0|-2.3|1.7|||Miettinen & Nurminen|||||1.7|-2.3|
91698205|NCT02738879|183291266|SUPERIORITY||Between Group Difference in Percentages|-4.1|||=|0.25|TWO_SIDED|95.0|-11.2|2.9|||Miettinen and Nurminen|||||2.9|-11.2|= 0.250
91698206|NCT02738879|183291267|SUPERIORITY||Between Group Difference in the LSM|-8.0|||=|0.016|TWO_SIDED|95.0|-14.6|-1.5|||LDA model|||The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.5|-14.6|= 0.016
91698207|NCT02738879|183291268|SUPERIORITY||Event Rate Ratio|0.81|||=|0.041|TWO_SIDED|95.0|0.67|0.99|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.99|0.67|= 0.041
91698208|NCT02738879|183291269|SUPERIORITY||Event Rate Ratio|0.83|||=|0.473|TWO_SIDED|95.0|0.51|1.37|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.37|0.51|= 0.473
91759116|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.3522|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3522
91730079|NCT03992872|183355662|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6444|TWO_SIDED|95.0|0.5|1.55||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.55|0.50|0.6444
91730080|NCT03992872|183355662|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6198|TWO_SIDED|95.0|0.57|1.41||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 57: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.41|0.57|0.6198
91730081|NCT03992872|183355662|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6451|TWO_SIDED|95.0|0.55|1.45||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 182: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.45|0.55|0.6451
91730082|NCT03992872|183355663|SUPERIORITY|||||||0.0211|||||||Fisher Exact|"Day 8~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.0211
91491712|NCT01323959|182856253|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|95.7|||||TWO_SIDED|95.0|87.8|99.1|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||99.1|87.8|
91730083|NCT03992872|183355663|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
91730084|NCT03992872|183355663|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 57.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
91730085|NCT03992872|183355663|SUPERIORITY|||||||0.1124|||||||Fisher Exact|"Day 182.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.1124
91730086|NCT03992872|183355664|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1 : Subjects with Titer \>=40"||||>0.9999
91730087|NCT03992872|183355664|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 1: Subjects with Titer \>=160"||||>0.9999
91730088|NCT03992872|183355664|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1: Subjects with Titer \>=640"||||1.0000
91730089|NCT03992872|183355664|SUPERIORITY|||||||0.0257|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8 : Subjects with Titer \>=40"||||0.0257
91730090|NCT03992872|183355664|SUPERIORITY|||||||0.037|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 8: Subjects with Titer \>=160"||||0.0370
91730091|NCT03992872|183355664|SUPERIORITY|||||||0.1806|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8: Subjects with Titer \>=640"||||0.1806
91730092|NCT03992872|183355664|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 22: Subjects with Titer \>=40"||||1.0000
91730093|NCT03992872|183355664|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=160"||||1.0000
91730094|NCT03992872|183355664|SUPERIORITY|||||||0.0797|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=640"||||0.0797
91730095|NCT03992872|183355664|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=40"||||1.0000
91491713|NCT01323959|182856253|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|100.0|||||TWO_SIDED|95.0|94.8|100.0|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||100|94.8|
91730096|NCT03992872|183355664|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=160"||||1.0000
91730097|NCT03992872|183355664|SUPERIORITY|||||||0.1284|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 640"||||0.1284
91730098|NCT03992872|183355664|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer \>= 40"||||1.0000
91730099|NCT03992872|183355664|SUPERIORITY|||||||0.6411|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=160"||||0.6411
91730100|NCT03992872|183355664|SUPERIORITY|||||||0.5382|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=640"||||0.5382
91730101|NCT03992872|183355664|SUPERIORITY|||||||0.4915|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 40"||||0.4915
91730102|NCT03992872|183355664|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 160"||||>0.9999
91730103|NCT03992872|183355664|SUPERIORITY|||||||0.552|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 640"||||0.5520
91730104|NCT03992872|183355665|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.51||||0.0277|TWO_SIDED|95.0|1.05|2.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.19|1.05|0.0277
91730105|NCT03992872|183355665|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.83||||0.0088|TWO_SIDED|95.0|1.17|2.86||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.86|1.17|0.0088
91730106|NCT03992872|183355665|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.68||||0.0475|TWO_SIDED|95.0|1.01|2.82||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.82|1.01|0.0475
91730107|NCT03992872|183355666|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
91730108|NCT03992872|183355666|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
91730109|NCT03992872|183355667|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|45.17|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE~NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
91730110|NCT03992872|183355667|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|47.34|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
91730111|NCT03992872|183355667|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|55.74|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
91698209|NCT02738879|183291270|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.624|TWO_SIDED|95.0|-6.2|3.7|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.7|-6.2|= 0.624
91698210|NCT02738879|183291271|SUPERIORITY||Between Group Difference in Percentages|18.8|||<|0.001|TWO_SIDED|95.0|11.6|25.7|||Miettinen and Nurminen|||||25.7|11.6|< 0.001
91698211|NCT02738879|183291272|SUPERIORITY||Between Group Difference in the LSM|-6.5|||=|0.02|TWO_SIDED|95.0|-11.9|-1.0|||LDA|||Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.0|-11.9|= 0.020
91698212|NCT02738879|183291273|OTHER|95% CI|Between Group Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-9.1|5.0|||Miettinen & Nurminen|||||5.0|-9.1|
91698213|NCT02738879|183291274|SUPERIORITY||Event Rate Ratio|0.76|||=|0.394|TWO_SIDED|95.0|0.4|1.44|||Negative Binomial Model|||The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.44|0.40|= 0.394
91698214|NCT02738879|183291275|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.74|TWO_SIDED|95.0|-8.2|5.8|||Miettinen and Nurminen|||The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.||5.8|-8.2|= 0.740
91730112|NCT03992872|183355669|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
91730113|NCT03992872|183355669|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
91491714|NCT01323959|182856255|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|92.1|||||TWO_SIDED|95.0|82.4|97.4|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.||97.4|82.4|
91698215|NCT02738879|183291276|SUPERIORITY||Between Group Difference in Percentages|-0.7|||=|0.712|TWO_SIDED|95.0|-4.7|3.2|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.2|-4.7|= 0.712
91698216|NCT02738879|183291277|SUPERIORITY||Between Group Difference in Percentages|5.3|||=|0.03|TWO_SIDED|95.0|0.5|10.1|||Miettinen and Nurminen|||||10.1|0.5|= 0.030
91698217|NCT01044290|183291308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||<|0.61|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||.7|-1.1|<0.61
91698218|NCT01044290|183291308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.02|TWO_SIDED|95.0|0.2|2.0|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.0|.2|<.02
91698219|NCT01044290|183291309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|||=|0.9|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||1.1|-1.2|=.9
91698220|NCT01044290|183291309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||<|0.97|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks.||1.1|-1.2|<.97
91698221|NCT01044290|183291310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||<|0.91|TWO_SIDED|95.0|-1.4|1.5|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||1.5|-1.4|<.91
91698222|NCT01044290|183291310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||=|0.42|TWO_SIDED|95.0|-2.1|0.9|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||0.9|-2.1|=.42
91698223|NCT01044290|183291311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||=|0.58|TWO_SIDED|95.0|-1.5|2.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.8|-1.5|=.58
91698224|NCT01044290|183291311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||<|0.97|TWO_SIDED|95.0|-2.1|2.2|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.2|-2.1|<.97
91730114|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 40"||||<0.0001
91730115|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 160"||||<0.0001
91513254|NCT02710630|182898018|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.26|STANDARD_DEVIATION|55.8|||TWO_SIDED|90.0|87.704|133.629|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.629|87.704|
91730116|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 640"||||<0.0001
91730117|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 40"||||<0.0001
91730118|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 160"||||<0.0001
91730119|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>=640"||||<0.0001
91730120|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 40"||||<0.0001
91730121|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subjects with Titer \>= 160"||||<0.0001
91730122|NCT03992872|183355670|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29 : Subjects with Titer \>=640"||||<0.0001
91730123|NCT03992872|183355671|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|23.12|||<|0.0001|TWO_SIDED|95.0|11.54|46.35||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||46.35|11.54|<0.0001
91730124|NCT03992872|183355671|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|172.51|||<|0.0001|TWO_SIDED|95.0|106.6|279.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||279.19|106.60|<0.0001
91730125|NCT03992872|183355671|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|118.45|||<|0.0001|TWO_SIDED|95.0|61.76|227.16||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naive alpha group) and 95% confidence interval||227.16|61.76|<0.0001
91730126|NCT03992872|183355672|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
91730127|NCT03992872|183355672|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 29~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
91730128|NCT00062764|183355678|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||paired t-test|||||||0.004
91730129|NCT00889005|183355705|SUPERIORITY_OR_OTHER|||||||0.927|||||||ANOVA|||||||0.927
91730130|NCT05122143|183355712|SUPERIORITY|||||||0.0085||||||Treatment D (A+B) versus Treatment C|ANCOVA|||"Treatment A + B were pooled to Treatment D for the Primary endpoint. The primary objective was to compare the efficacy of the AM-301 nasal spray (treatment D= A+B) and no treatment (C) in reducing nasal symptoms induced from HDM allergen exposure.~The TNSS value from the baseline exposure (at screening exposure visit 2) was subtracted from the TNSS value of the treatment exposure to obtain change from baseline. A lower value resembles less symptoms."||||0.0085
91730131|NCT03766906|183355717|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.003|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||.003
91730132|NCT03766906|183355718|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.022|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than zero at P\<0.05.|||||.022
91730133|NCT03766906|183355719|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.016|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.016
91730134|NCT03766906|183355720|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.002|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.002
91730135|NCT03766906|183355721|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.626|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.626
91698225|NCT01044290|183291312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.6|2.4|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.4|-.6|.25
91698226|NCT01044290|183291312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED|95.0|0.05|3.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||3.1|.05|<.05
91698227|NCT01044290|183291313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.57|TWO_SIDED|95.0|-1.0|1.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||1.8|-1.0|<.57
91698228|NCT01044290|183291313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||=|0.055|TWO_SIDED|95.0|-0.03|2.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||2.7|-0.03|=0.055
91698229|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.|Least-Squares Mean Double Delta Value|-0.99|||||ONE_SIDED|95.0||0.635||||||"Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).~Power Calculation:~Enrollment of 72 subjects would provide at least 84% power to conclude a negative effect, given that up to 16 subjects may withdraw early prior to beginning to replace subjects (at least 56 subjects evaluable), and assuming a standard deviation of ΔΔQTcF of 7 msec and an underlying effect of 5 msec."||0.635||
91698230|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.59|||||ONE_SIDED|95.0||2.2||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.200||
91698231|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.17|||||ONE_SIDED|95.0||1.795||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.795||
91698232|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.42|||||ONE_SIDED|95.0||3.044||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.044||
91698233|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.792||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.792||
91698234|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.45|||||ONE_SIDED|95.0||2.074||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.074||
91730136|NCT03766906|183355721|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.909|TWO_SIDED||||||t-test, 2 sided|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.||The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.909
91698235|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.83|||||ONE_SIDED|95.0||0.79||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||0.790||
91698236|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.03|||||ONE_SIDED|95.0||1.65||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.650||
91698237|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.53|||||ONE_SIDED|95.0||1.131||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.131||
91698238|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.815||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.815||
91698239|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.36|||||ONE_SIDED|95.0||3.997||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.997||
91698240|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.18|||||ONE_SIDED|95.0||3.812||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.812||
91698241|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.59|||||ONE_SIDED|95.0||4.228||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.228||
91698242|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|3.04|||||ONE_SIDED|95.0||4.674||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.674||
91698243|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.63|||||ONE_SIDED|95.0||3.259||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.259||
91698244|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.07|||||ONE_SIDED|95.0||1.566||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.566||
91491715|NCT01323959|182856255|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|79.4|||||TWO_SIDED|95.0|67.9|88.3|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||88.3|67.9|
91698245|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.82|||||ONE_SIDED|95.0||3.459||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.459||
91698246|NCT03613649|183291329|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.72|||||ONE_SIDED|95.0||3.415||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.415||
91698247|NCT03613649|183291334|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.19|||||ONE_SIDED|98.75|8.257|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 1 h after dose.|||8.257|
91730137|NCT03766906|183355721|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.905|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.905
91730138|NCT03766906|183355722|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.054|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.054
91730139|NCT03766906|183355723|SUPERIORITY||Mean Difference (Final Values)|3.48|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
91730140|NCT03766906|183355724|SUPERIORITY||Mean Difference (Final Values)|7.52|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
91759117|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0240
91759118|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0353
91698248|NCT03613649|183291334|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.79|||||ONE_SIDED|98.75|8.86|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 2 h after dose.|||8.860|
91698249|NCT03613649|183291334|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.62|||||ONE_SIDED|98.75|8.683|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 3 h after dose.|||8.683|
91698250|NCT03613649|183291334|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.63|||||ONE_SIDED|98.75|8.698|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 4 h after dose.|||8.698|
91698251|NCT02783729|183291365|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.773|||=|0.0003|TWO_SIDED|95.0|0.672|0.889||Based on mixed effect model repeated measurement (MMRM) model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.889|0.672|= 0.0003
91698252|NCT02783729|183291365|SUPERIORITY||LSGM Ratio|0.723|||<|0.0001|TWO_SIDED|95.0|0.628|0.832||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.832|0.628|< 0.0001
91698253|NCT02783729|183291366|SUPERIORITY||Least Squares Mean (LSM) Difference|7.07|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|5.61|8.54||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||8.54|5.61|< 0.0001
91513255|NCT02710630|182898018|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.76|STANDARD_DEVIATION|43.0|||TWO_SIDED|90.0|91.238|127.281|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.281|91.238|
91698254|NCT02783729|183291366|SUPERIORITY||LSM Difference|8.03|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|6.57|9.49||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||9.49|6.57|< 0.0001
91698255|NCT02783729|183291367|SUPERIORITY||LSM Difference|-23.96|STANDARD_ERROR_OF_MEAN|3.068|<|0.0001|TWO_SIDED|95.0|-29.98|-17.95||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||||-17.95|-29.98|< 0.0001
91698256|NCT02783729|183291367|SUPERIORITY||LSM Difference|-25.35|STANDARD_ERROR_OF_MEAN|3.067|<|0.0001|TWO_SIDED|95.0|-31.36|-19.34|||MMRM|||||-19.34|-31.36|< 0.0001
91698257|NCT02783729|183291368|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-6.65|STANDARD_ERROR_OF_MEAN|2.298|=|0.0038|TWO_SIDED|95.0|-11.15|-2.15|||MMRM|||||-2.15|-11.15|= 0.0038
91698258|NCT02783729|183291368|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.309|=|0.0005|TWO_SIDED|95.0|-12.53|-3.47|||MMRM|||||-3.47|-12.53|= 0.0005
91730141|NCT00836901|183355725|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.7||||||90.0|93.19|102.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.43|93.19|
91528432|NCT00708305|182932216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.0783|TWO_SIDED|95.0|-0.08|0.0||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.00|-0.08|0.0783
91698259|NCT02783729|183291369|SUPERIORITY||LSM Difference|-9.63|STANDARD_ERROR_OF_MEAN|4.029|=|0.0171|TWO_SIDED|95.0|-17.53|-1.72||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 5 mg||-1.72|-17.53|= 0.0171
91698260|NCT02783729|183291369|SUPERIORITY||LSM Difference|-10.74|STANDARD_ERROR_OF_MEAN|4.04|=|0.008|TWO_SIDED|95.0|-18.67|-2.81||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 10 mg||-2.81|-18.67|= 0.008
91698261|NCT02783729|183291370|SUPERIORITY||LSGM Ratio|0.874|||=|0.0218|TWO_SIDED|95.0|0.78|0.981||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||0.981|0.78|= 0.0218
91698262|NCT02783729|183291370|OTHER||LSGM Ratio|0.818|||=|0.0006|TWO_SIDED|95.0|0.729|0.917||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||0.917|0.729|= 0.0006
91698263|NCT02783729|183291370|SUPERIORITY||LSGM Ratio|0.634|||<|0.0001|TWO_SIDED|95.0|0.556|0.724||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||0.724|0.556|< 0.0001
91698264|NCT02783729|183291370|SUPERIORITY||LSGM Ratio|0.594|||<|0.0001|TWO_SIDED|95.0|0.521|0.677||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||0.677|0.521|< 0.0001
91698265|NCT02783729|183291370|SUPERIORITY||LSM Difference|-6.16|STANDARD_ERROR_OF_MEAN|2.544|=|0.0154|TWO_SIDED|95.0|-11.15|-1.17||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||-1.17|-11.15|= 0.0154
91698266|NCT02783729|183291370|SUPERIORITY||LSM Difference|-15.03|STANDARD_ERROR_OF_MEAN|2.542|<|0.0001|TWO_SIDED|95.0|-20.01|-10.05||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 10 mg||-10.05|-20.01|< 0.0001
91698267|NCT02783729|183291370|SUPERIORITY||LSM Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.876|=|0.0073|TWO_SIDED|95.0|-13.36|-2.08||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||-2.08|-13.36|= 0.0073
91513256|NCT02710630|182898019|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.26|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|101.627|137.621|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.621|101.627|
91698268|NCT02783729|183291370|SUPERIORITY||LSM Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.883|=|0.0016|TWO_SIDED|95.0|-14.75|-3.45|||MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||-3.45|-14.75|= 0.0016
91698269|NCT02783729|183291370|SUPERIORITY||LSM Difference|10.25|STANDARD_ERROR_OF_MEAN|3.094|=|0.001|TWO_SIDED|95.0|4.18|16.32||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 5 mg||16.32|4.18|= 0.001
91698270|NCT02783729|183291370|SUPERIORITY||LSM Difference|23.1|STANDARD_ERROR_OF_MEAN|3.085|<|0.0001|TWO_SIDED|95.0|17.04|29.15||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 10 mg||29.15|17.04|< 0.0001
91698271|NCT02783729|183291370|SUPERIORITY||LSM Difference|19.41|STANDARD_ERROR_OF_MEAN|3.457|<|0.0001|TWO_SIDED|95.0|12.63|26.2||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 5 mg||26.2|12.63|< 0.0001
91698272|NCT02783729|183291370|SUPERIORITY||LSM Difference|24.1|STANDARD_ERROR_OF_MEAN|3.456|<|0.0001|TWO_SIDED|95.0|17.32|30.88||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 10 mg||30.88|17.32|< 0.0001
91698273|NCT02783729|183291371|SUPERIORITY||LSGM Ratio|0.898|||=|0.0122|TWO_SIDED|95.0|0.825|0.977||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.977|0.825|= 0.0122
91698274|NCT02783729|183291371|SUPERIORITY||LSGM Ratio|0.83|||<|0.0001|TWO_SIDED|95.0|0.763|0.902||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 10 mg||0.902|0.763|< 0.0001
91698275|NCT02783729|183291371|SUPERIORITY||LSGM Ratio|0.882|||=|0.0176|TWO_SIDED|95.0|0.796|0.978||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.978|0.796|= 0.0176
91698276|NCT02783729|183291371|SUPERIORITY||LSGM Ratio|0.811|||<|0.0001|TWO_SIDED|95.0|0.732|0.899||Based on MMRM model model with log transformation of sSOL and with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||0.899|0.732|< 0.0001
91698277|NCT02783729|183291371|SUPERIORITY||LSM Difference|8.12|STANDARD_ERROR_OF_MEAN|4.484|=|0.0706|TWO_SIDED|95.0|-0.68|16.91||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||16.91|-0.68|= 0.0706
91759119|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0361
91759120|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.1921|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.1921
91698278|NCT02783729|183291371|SUPERIORITY||LSM Difference|-5.81|STANDARD_ERROR_OF_MEAN|4.481|=|0.1949|TWO_SIDED|95.0|-14.61|2.98||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 10 mg||2.98|-14.61|= 0.1949
91698279|NCT02783729|183291371|SUPERIORITY||LSM Difference|14.45|STANDARD_ERROR_OF_MEAN|5.241|=|0.0059|TWO_SIDED|95.0|4.16|24.73||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||24.73|4.16|= 0.0059
91698280|NCT02783729|183291371|SUPERIORITY||LSM Difference|5.36|STANDARD_ERROR_OF_MEAN|5.241|=|0.3064|TWO_SIDED|95.0|-4.92|15.65||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||15.65|-4.92|= 0.3064
91698281|NCT02783729|183291371|SUPERIORITY||LSM Difference|-6.57|STANDARD_ERROR_OF_MEAN|5.325|=|0.2174|TWO_SIDED|95.0|-17.02|3.88||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 5 mg||3.88|-17.02|= 0.2174
91698282|NCT02783729|183291371|SUPERIORITY||LSM Difference|8.88|STANDARD_ERROR_OF_MEAN|5.313|=|0.0949|TWO_SIDED|95.0|-1.55|19.31||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 10 mg||19.31|-1.55|= 0.0949
91698283|NCT02783729|183291371|SUPERIORITY||LSM Difference|-6.82|STANDARD_ERROR_OF_MEAN|6.207|=|0.2718|TWO_SIDED|95.0|-19.01|5.36||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||5.36|-19.01|= 0.2718
91698284|NCT02783729|183291371|SUPERIORITY||LSM Difference|7.43|STANDARD_ERROR_OF_MEAN|6.206|=|0.2317|TWO_SIDED|95.0|-4.75|19.61||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||19.61|-4.75|= 0.2317
91491716|NCT01323959|182856255|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|84.1|||||TWO_SIDED|95.0|73.3|91.8|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||91.8|73.3|
91491717|NCT01768286|182856271|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
91698285|NCT02783729|183291372|SUPERIORITY||LSM Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.063|=|0.1963|TWO_SIDED|95.0|-3.46|0.71||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.71|-3.46|= 0.1963
91698286|NCT02783729|183291372|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate|LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|1.06|=|0.1093|TWO_SIDED|95.0|-0.38|3.78|||MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 10 mg||3.78|-0.38|= 0.1093
91698287|NCT02783729|183291372|SUPERIORITY||LSM Difference|-1.53|STANDARD_ERROR_OF_MEAN|1.247|=|0.2196|TWO_SIDED|95.0|-3.98|0.92||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.92|-3.98|= 0.2196
91698288|NCT02783729|183291372|SUPERIORITY||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|1.246|=|0.4013|TWO_SIDED|95.0|-1.4|3.49||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||3.49|-1.4|= 0.4013
91698289|NCT02783729|183291373|SUPERIORITY||LSGM Ratio|0.85|||=|0.0092|TWO_SIDED|95.0|0.752|0.961||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 5 mg||0.961|0.752|= 0.0092
91698290|NCT02783729|183291373|SUPERIORITY||LSGM Ratio|0.795|||=|0.0002|TWO_SIDED|95.0|0.704|0.899||Based on MMRM model with factors of age group, region, treatment, visit (Days1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 10 mg||0.899|0.704|= 0.0002
91698291|NCT02783729|183291373|SUPERIORITY||LSM Difference|-33.4|STANDARD_ERROR_OF_MEAN|2.711|<|0.0001|TWO_SIDED|95.0|-38.71|-28.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 5 mg||-28.09|-38.71|< 0.0001
91491718|NCT01768286|182856271|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
91698292|NCT02783729|183291373|SUPERIORITY||LSM Difference|-42.27|STANDARD_ERROR_OF_MEAN|2.705|<|0.0001|TWO_SIDED|95.0|-47.57|-36.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 10 mg||-36.97|-47.57|< 0.0001
91730142|NCT00836901|183355726|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.28||||||90.0|97.09|101.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.53|97.09|
91491719|NCT01768286|182856271|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
91698293|NCT02783729|183291373|SUPERIORITY||LSM Difference|-21.66|STANDARD_ERROR_OF_MEAN|2.221|<|0.0001|TWO_SIDED|95.0|-26.01|-17.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-17.3|-26.01|< 0.0001
91730143|NCT00836901|183355727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.64||||||90.0|96.12|99.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.19|96.12|
91491720|NCT01768286|182856271|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
91698294|NCT02783729|183291373|SUPERIORITY||LSM Difference|-28.33|STANDARD_ERROR_OF_MEAN|2.219|<|0.0001|TWO_SIDED|95.0|-32.68|-23.98||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-23.98|-32.68|< 0.0001
91698295|NCT02783729|183291373|SUPERIORITY||LSM Difference|44.05|STANDARD_ERROR_OF_MEAN|3.291|<|0.0001|TWO_SIDED|95.0|37.59|50.51||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||50.51|37.59|< 0.0001
91698296|NCT02783729|183291373|SUPERIORITY||LSM Difference|56.9|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|50.46|63.34||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||63.34|50.46|< 0.0001
91698297|NCT02783729|183291374|SUPERIORITY||LSM Difference|9.01|STANDARD_ERROR_OF_MEAN|0.666|<|0.0001|TWO_SIDED|95.0|7.7|10.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 5 mg||10.31|7.7|< 0.0001
91698298|NCT02783729|183291374|SUPERIORITY||LSM Difference|11.6|STANDARD_ERROR_OF_MEAN|0.664|<|0.0001|TWO_SIDED|95.0|10.3|12.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 10 mg||12.9|10.3|< 0.0001
91698299|NCT02783729|183291375|SUPERIORITY||LSM Difference|-16.41|STANDARD_ERROR_OF_MEAN|2.457|<|0.0001|TWO_SIDED|95.0|-21.23|-11.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-11.6|-21.23|< 0.0001
91698300|NCT02783729|183291375|SUPERIORITY||LSM Difference|-17.76|STANDARD_ERROR_OF_MEAN|2.451|<|0.0001|TWO_SIDED|95.0|-22.57|-12.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-12.96|-22.57|< 0.0001
91698301|NCT02783729|183291375|SUPERIORITY||LSM Difference|34.16|STANDARD_ERROR_OF_MEAN|3.673|<|0.0001|TWO_SIDED|95.0|26.95|41.36||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||41.36|26.95|< 0.0001
91698302|NCT02783729|183291375|SUPERIORITY||LSM Difference|38.85|STANDARD_ERROR_OF_MEAN|3.672|<|0.0001|TWO_SIDED|95.0|31.64|46.05||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||46.05|31.64|< 0.0001
91698303|NCT02783729|183291376|SUPERIORITY||LSGM Ratio|0.815|||<|0.0001|TWO_SIDED|95.0|0.745|0.891||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||0.891|0.745|< 0.0001
91698304|NCT02783729|183291376|SUPERIORITY||LSGM Ratio|0.753|||<|0.0001|TWO_SIDED|95.0|0.689|0.823||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||0.823|0.689|< 0.0001
91730144|NCT00836901|183355728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.59||||||90.0|85.64|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|85.64|
91730145|NCT00836901|183355729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.44||||||90.0|87.83|101.54|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.54|87.83|
91698305|NCT02783729|183291376|SUPERIORITY||LSGM Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.671|0.837||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||0.837|0.671|< 0.0001
91698306|NCT02783729|183291376|SUPERIORITY||LSGM Ratio|0.689|||<|0.0001|TWO_SIDED|95.0|0.618|0.769||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||0.769|0.618|< 0.0001
91513257|NCT02710630|182898019|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|87.26|STANDARD_DEVIATION|60.2|||TWO_SIDED|90.0|69.404|109.722|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||109.722|69.404|
91698307|NCT02783729|183291376|SUPERIORITY||LSM Difference|-12.41|STANDARD_ERROR_OF_MEAN|4.764|=|0.0093|TWO_SIDED|95.0|-21.76|-3.06||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 5 mg||-3.06|-21.76|= 0.0093
91698308|NCT02783729|183291376|SUPERIORITY||LSM Difference|-26.34|STANDARD_ERROR_OF_MEAN|4.762|<|0.0001|TWO_SIDED|95.0|-35.68|-16.99||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||-16.99|-35.68|< 0.0001
91698309|NCT02783729|183291376|SUPERIORITY||LSM Difference|-11.49|STANDARD_ERROR_OF_MEAN|5.573|=|0.0396|TWO_SIDED|95.0|-22.42|-0.55||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||-0.55|-22.42|= 0.0396
91698310|NCT02783729|183291376|SUPERIORITY||LSM Difference|-20.57|STANDARD_ERROR_OF_MEAN|5.574|=|0.0002|TWO_SIDED|95.0|-31.51|-9.63||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||-9.63|-31.51|= 0.0002
91698311|NCT02783729|183291376|SUPERIORITY||LSM Difference|19.05|STANDARD_ERROR_OF_MEAN|5.619|=|0.0007|TWO_SIDED|95.0|8.03|30.08||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 5 mg||30.08|8.03|= 0.0007
91698312|NCT02783729|183291376|SUPERIORITY||LSM Difference|34.51|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|23.5|45.52||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 10 mg||45.52|23.5|< 0.0001
91730146|NCT00836901|183355730|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.08||||||90.0|87.19|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.52|87.19|
91730147|NCT01220687|183355731|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.0012|TWO_SIDED||||||t-test, 2 sided|||||||0.0012
91730148|NCT01220687|183355732|SUPERIORITY||Rate Ratio|1.91|||<|0.0001|TWO_SIDED|95.0|1.68|2.18|||Poisson|||||2.18|1.68|<0.0001
91730149|NCT04250207|183355743|SUPERIORITY|||||||0.0065|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0065
91730150|NCT04250207|183355743|SUPERIORITY|||||||0.0344|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0344
91730151|NCT04250207|183355744|SUPERIORITY|||||||0.3587|||||||Wilcoxon Rank Sum Test|||Baseline||||0.3587
91491721|NCT00622284|182856292|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.|Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.0005||97.5|0.13|0.31||Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.|ANCOVA|||Linagliptin versus Glimepiride||0.31|0.13|0.0005
91698313|NCT02783729|183291376|SUPERIORITY||LSM Difference|23.57|STANDARD_ERROR_OF_MEAN|6.565|=|0.0003|TWO_SIDED|95.0|10.68|36.45||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 5 mg||36.45|10.68|= 0.0003
91698314|NCT02783729|183291376|SUPERIORITY||LSM Difference|37.82|STANDARD_ERROR_OF_MEAN|6.565|<|0.0001|TWO_SIDED|95.0|24.94|50.71||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 10 mg||50.71|24.94|< 0.0001
91698315|NCT02783729|183291377|SUPERIORITY||LSM Difference|3.76|STANDARD_ERROR_OF_MEAN|1.122|=|0.0008|TWO_SIDED|95.0|1.56|5.97||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 5 mg||5.97|1.56|= 0.0008
91698316|NCT02783729|183291377|SUPERIORITY||LSM Difference|6.84|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.64|9.04||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 10 mg||9.04|4.64|< 0.0001
91698317|NCT02783729|183291377|SUPERIORITY||LSM Difference|4.61|STANDARD_ERROR_OF_MEAN|1.319|=|0.0005|TWO_SIDED|95.0|2.02|7.19||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 5 mg||7.19|2.02|= 0.0005
91730152|NCT04250207|183355744|SUPERIORITY|||||||0.5724|||||||Wilcoxon Rank Sum Test|||Baseline||||0.5724
91730153|NCT04250207|183355744|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3703
91730154|NCT04250207|183355744|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 1||||> 0.9999
91730155|NCT04250207|183355744|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3703
91730156|NCT04250207|183355744|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
91730157|NCT04250207|183355744|SUPERIORITY|||||||0.0257|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0257
91730158|NCT04250207|183355744|SUPERIORITY|||||||0.7263|||||||Wilcoxon Rank Sum Test|||||||0.7263
91730159|NCT04250207|183355744|SUPERIORITY|||||||0.0607|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0607
91730160|NCT04250207|183355744|SUPERIORITY|||||||0.046|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0460
91730161|NCT04250207|183355744|SUPERIORITY|||||||0.0111|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0111
91730162|NCT04250207|183355744|SUPERIORITY|||||||0.0011|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0011
91730163|NCT04250207|183355744|SUPERIORITY|||||||0.02|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0200
91730164|NCT04250207|183355744|SUPERIORITY|||||||0.0476|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0476
91528433|NCT00708305|182932216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0531|TWO_SIDED|95.0|0.0|0.07||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.00|0.0531
91528434|NCT00708305|182932216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.14||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.14|0.07|<0.0001
91528435|NCT00708305|182932216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.0005|TWO_SIDED|95.0|0.03|0.15||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.15|0.03|0.0005
91528436|NCT00708305|182932216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.20|0.08|<0.0001
91528437|NCT00708305|182932216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07|||<|0.0001|TWO_SIDED|95.0|0.04|0.1||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.10|0.04|<0.0001
91698318|NCT02783729|183291377|SUPERIORITY||LSM Difference|7.18|STANDARD_ERROR_OF_MEAN|1.319|<|0.0001|TWO_SIDED|95.0|4.6|9.77||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 10 mg||9.77|4.6|< 0.0001
91698319|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|0.41|||=|0.9028|TWO_SIDED|95.0|-6.22|7.04||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 5 mg||7.04|-6.22|= 0.9028
91698320|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|2.49|||=|0.4699|TWO_SIDED|95.0|-4.2|9.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 10 mg||9.18|-4.2|= 0.4699
91698321|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|5.58|||=|0.0566|TWO_SIDED|95.0|-0.14|11.31|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by age group.||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||11.31|-0.14|= 0.0566
91730165|NCT04250207|183355744|SUPERIORITY|||||||0.0065|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0065
91730166|NCT04250207|183355744|SUPERIORITY|||||||0.0344|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0344
91730167|NCT04250207|183355744|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0250
91730168|NCT04250207|183355744|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0733
91730169|NCT04250207|183355744|SUPERIORITY|||||||0.0072|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0072
91730170|NCT04250207|183355744|SUPERIORITY|||||||0.1124|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1124
91730171|NCT04250207|183355744|SUPERIORITY|||||||0.0199|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0199
91491722|NCT00622284|182856293|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0004||97.5|0.09|0.3||This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.|ANCOVA|||Linagliptin versus Glimepiride||0.30|0.09|0.0004
91491723|NCT00622284|182856294|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001||97.5|-2.91|-2.09||This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.|ANCOVA|||Linagliptin versus Glimepiride||-2.09|-2.91|<0.0001
91528438|NCT00708305|182932217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.4309|TWO_SIDED|95.0|-0.03|0.01||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.01|-0.03|0.4309
91730172|NCT04250207|183355744|SUPERIORITY|||||||0.2331|||||||Wilcoxon Rank Sum Test|||Week 24||||0.2331
91730173|NCT04250207|183355744|SUPERIORITY|||||||0.0024|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0024
91730174|NCT04250207|183355744|SUPERIORITY|||||||0.1672|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1672
91730175|NCT04250207|183355744|SUPERIORITY|||||||0.0047|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0047
91730176|NCT04250207|183355744|SUPERIORITY|||||||0.0625|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0625
91730177|NCT04250207|183355745|SUPERIORITY|||||||0.2434|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2434
91730178|NCT04250207|183355745|SUPERIORITY|||||||0.2126|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2126
91698322|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|7.57|||=|0.0122|TWO_SIDED|95.0|1.71|13.44||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||13.44|1.71|= 0.0122
91730179|NCT04250207|183355745|SUPERIORITY|||||||0.079|||||||Wilcoxon Rank Sum Test|||Week 2||||0.0790
91730180|NCT04250207|183355745|SUPERIORITY|||||||0.3043|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3043
91491724|NCT00622284|182856295|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||97.5|-3.17|-2.19||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|ANCOVA|||Linagliptin versus Glimepiride||-2.19|-3.17|<0.0001
91491725|NCT00622284|182856296|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
91491726|NCT00622284|182856297|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
91491727|NCT00622284|182856298|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001||95.0|3.51|10.16|||ANCOVA|||Linagliptin versus Glimepiride||10.16|3.51|<0.0001
91491728|NCT00622284|182856299|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.38|STANDARD_ERROR_OF_MEAN|1.97||0.0012||95.0|2.51|10.25|||ANCOVA|||Linagliptin versus Glimepiride||10.25|2.51|0.0012
91491729|NCT00622284|182856300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.625||||0.0004||95.0|0.482|0.811|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.811|0.482|0.0004
91491730|NCT00622284|182856301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.654||||0.003||95.0|0.494|0.866|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.866|0.494|0.0030
91491731|NCT00622284|182856302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.648||||0.0025||95.0|0.489|0.859|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.859|0.489|0.0025
91491732|NCT00622284|182856303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.689||||0.024||95.0|0.498|0.952|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.952|0.498|0.0240
91491733|NCT00622284|182856304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.0018||95.0|0.56|0.875|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.875|0.560|0.0018
91698323|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|4.42|||=|0.2176|TWO_SIDED|95.0|-2.5|11.34||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 5 mg||11.34|-2.5|= 0.2176
91698324|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|6.47|||=|0.0773|TWO_SIDED|95.0|-0.55|13.49||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 10 mg||13.49|-0.55|= 0.0773
91730181|NCT04250207|183355745|SUPERIORITY|||||||0.0357|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0357
91730182|NCT04250207|183355745|SUPERIORITY|||||||0.0803|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0803
91730183|NCT04250207|183355745|SUPERIORITY|||||||0.015|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0150
91730184|NCT04250207|183355745|SUPERIORITY|||||||0.0012|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0012
91730185|NCT04250207|183355745|SUPERIORITY|||||||0.0314|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0314
91730186|NCT04250207|183355745|SUPERIORITY|||||||0.0019|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0019
91491734|NCT00622284|182856305|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.47|STANDARD_ERROR_OF_MEAN|5.77||0.0918||95.0|-21.07|1.59|||ANCOVA|||Linagliptin versus Glimepiride||1.59|-21.07|0.0918
91491735|NCT02935842|182856321|OTHER|||||||||||||||||First Reliable Change (RC), Reliable Change Index (RCI) were calculated on every individual score. Further, ANOVAs and t-tests were administered in order to verify differences between groups or interventions. Significance levels were set at p \< .05.|Reliable Change / Reliable Change Index according to Jacobson \& Truax (1991). There, on the basis of every individual score, the change in performance (i.e. BL-4Weeks/ BL-6Months) has been calculated and is reported with level of significance as well as effect size.|||
91491736|NCT02935842|182856321|OTHER|||||||0.05|||||||ANOVA|||||||.05
91491737|NCT02935842|182856325|OTHER|||||||0.05|||||||ANOVA|||||||.05
91491738|NCT02935842|182856327|OTHER|||||||0.05|||||||ANOVA|||||||.05
91491739|NCT02774954|182856328|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
91491740|NCT02774954|182856329|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
91491741|NCT01552694|182856346|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted p-value compares the change (week 8 - baseline) for plasma hsCRP between the 2 groups.|t-test, 2 sided|||||||0.006
91491742|NCT01552694|182856347|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis.|t-test, 2 sided|||||||0.24
91491743|NCT01552694|182856348|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis|t-test, 2 sided|||||||0.78
91491744|NCT03338010|182856351|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
91491745|NCT03338010|182856352|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
91491746|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|1.0||||0.602|TWO_SIDED|95.0|-2.8|4.8|||Mixed Models Analysis|||Before Morning Meal Glucose||4.8|-2.8|0.602
91730187|NCT04250207|183355745|SUPERIORITY|||||||0.017|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0170
91730188|NCT04250207|183355745|SUPERIORITY|||||||0.0021|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0021
91730189|NCT04250207|183355745|SUPERIORITY|||||||0.0127|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0127
91730190|NCT04250207|183355745|SUPERIORITY|||||||0.0014|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0014
91491747|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|-3.7||||0.373|TWO_SIDED|95.0|-11.8|4.4|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||4.4|-11.8|0.373
91698325|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|8.85|||=|0.0054|TWO_SIDED|95.0|2.68|15.02||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||15.02|2.68|= 0.0054
91698326|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|10.89|||=|0.0008|TWO_SIDED|95.0|4.61|17.17||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||17.17|4.61|= 0.0008
91698327|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|6.9|||=|0.003|TWO_SIDED|95.0|2.66|11.14||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||11.14|2.66|= 0.003
91698328|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|7.5|||=|0.0016|TWO_SIDED|95.0|3.19|11.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||11.81|3.19|= 0.0016
91730191|NCT04250207|183355745|SUPERIORITY|||||||0.0677|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0677
91730192|NCT04250207|183355745|SUPERIORITY|||||||0.0243|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0243
91730193|NCT04250207|183355745|SUPERIORITY|||||||0.1867|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1867
91730194|NCT04250207|183355745|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0250
91730195|NCT04250207|183355745|SUPERIORITY|||||||0.3213|||||||Wilcoxon Rank Sum Test|||Week 24||||0.3213
91730196|NCT04250207|183355745|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0298
91730197|NCT04250207|183355745|SUPERIORITY|||||||0.1449|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1449
91730198|NCT04250207|183355745|SUPERIORITY|||||||0.0947|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0947
91730199|NCT04250207|183355745|SUPERIORITY|||||||0.5181|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5181
91730200|NCT04250207|183355745|SUPERIORITY|||||||0.1898|||||||Wilcoxon Rank Sum Test|||Week 52||||0.1898
91730201|NCT04250207|183355746|SUPERIORITY|||||||0.0021|||||||Log Rank|||||||0.0021
91698329|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|2.22|||=|0.3643|TWO_SIDED|95.0|-2.56|7.01||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 5 mg||7.01|-2.56|= 0.3643
91730202|NCT04250207|183355746|SUPERIORITY|||||||0.1696|||||||Log Rank|||||||0.1696
91698330|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|2.82|||=|0.2553|TWO_SIDED|95.0|-2.02|7.66||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 10 mg||7.66|-2.02|= 0.2553
91698331|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|9.69|||=|0.0016|TWO_SIDED|95.0|3.98|15.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||15.4|3.98|= 0.0016
91698332|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|7.29|||=|0.0128|TWO_SIDED|95.0|1.8|12.79||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||12.79|1.8|= 0.0128
91730203|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4872|||||||Chi-square or Fisher exact|||Week 5||||0.4872
91730204|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4634|||||||Chi-square or Fisher exact|||Week 5||||0.4634
91730205|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.605|||||||Chi-square or Fisher exact|||Week 7||||0.6050
91698333|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|8.16|||=|0.0051|TWO_SIDED|95.0|2.51|13.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||13.81|2.51|= 0.0051
91730206|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4762|||||||Chi-square or Fisher exact|||Week 7||||0.4762
91730207|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
91730208|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
91730209|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4227|||||||Chi-square or Fisher exact|||Week 12||||0.4227
91730210|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6796|||||||Chi-square or Fisher exact|||Week 12||||0.6796
91491748|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|-3.3||||0.351|TWO_SIDED|95.0|-10.3|3.7|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||3.7|-10.3|0.351
91491749|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|4.9||||0.23|TWO_SIDED|95.0|-3.1|12.8|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||12.8|-3.1|0.230
91698334|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|5.76|||=|0.0389|TWO_SIDED|95.0|0.34|11.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7nights: Zolpidem ER, Lemborexant 10 mg||11.18|0.34|= 0.0389
91698335|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|34.26|||<|0.0001|TWO_SIDED|95.0|26.46|42.06||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 5 mg||42.06|26.46|< 0.0001
91698336|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|47.57|||<|0.0001|TWO_SIDED|95.0|40.02|55.13||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 10 mg||55.13|40.02|< 0.0001
91698337|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|4.89|||=|0.2534|TWO_SIDED|95.0|-3.49|13.28||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||13.28|-3.49|= 0.2534
91698338|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|18.25|||<|0.0001|TWO_SIDED|95.0|10.1|26.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO: Days 1/2: Zolpidem ER, Lemborexant 10 mg||26.4|10.1|< 0.0001
91698339|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.06|30.35||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 5 mg||30.35|14.06|< 0.0001
91698340|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|24.13|||<|0.0001|TWO_SIDED|95.0|16.16|32.1||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 10 mg||32.1|16.16|< 0.0001
91698341|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|9.59|||=|0.023|TWO_SIDED|95.0|1.36|17.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||17.81|1.36|= 0.023
91698342|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|11.43|||=|0.0058|TWO_SIDED|95.0|3.38|19.48||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||19.48|3.38|= 0.0058
91698343|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|7.3|||=|0.0222|TWO_SIDED|95.0|1.27|13.33||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 5||13.33|1.27|= 0.0222
91698344|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|10.84|||=|0.0013|TWO_SIDED|95.0|4.57|17.11||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||17.11|4.57|= 0.0013
91698345|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|0.21|||=|0.9495|TWO_SIDED|95.0|-6.17|6.58||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||6.58|-6.17|= 0.9495
91698346|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|3.72|||=|0.2708|TWO_SIDED|95.0|-2.88|10.32||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO: First 7 nights: Zolpidem ER, Lemborexant 10 mg||10.32|-2.88|= 0.2708
91698347|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|7.91|||=|0.0322|TWO_SIDED|95.0|0.86|14.96||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||14.96|0.86|= 0.0322
91698348|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|7.69|||=|0.0363|TWO_SIDED|95.0|0.68|14.71||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||14.71|0.68|= 0.0363
91698349|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|0.05|||=|0.9885|TWO_SIDED|95.0|-7.14|7.24||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||7.24|-7.14|= 0.9885
91698350|NCT02783729|183291378|SUPERIORITY||Difference of Percentage|-0.16|||=|0.9651|TWO_SIDED|95.0|-7.31|6.99||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||6.99|-7.31|= 0.9651
91698351|NCT02783729|183291379|SUPERIORITY||LSM Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.319|=|0.0006|TWO_SIDED|95.0|-1.73|-0.47||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||-0.47|-1.73|= 0.0006
91698352|NCT02783729|183291379|SUPERIORITY||LSM Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.32|=|0.0007|TWO_SIDED|95.0|-1.71|-0.46||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||-0.46|-1.71|= 0.0007
91698353|NCT02783729|183291379|SUPERIORITY||LSM Difference|0.32|STANDARD_ERROR_OF_MEAN|0.301|=|0.2951|TWO_SIDED|95.0|-0.28|0.91||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||0.91|-0.28|= 0.2951
91698354|NCT02783729|183291379|SUPERIORITY||LSM Difference|0.33|STANDARD_ERROR_OF_MEAN|0.303|=|0.2744|TWO_SIDED|95.0|-0.26|0.92||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||0.92|-0.26|= 0.2744
91730211|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4642|||||||Chi-square or Fisher exact|||Week 16||||0.4642
91698355|NCT02783729|183291380|SUPERIORITY||LSM Difference|-1.26|STANDARD_ERROR_OF_MEAN|1.063|=|0.2348|TWO_SIDED|95.0|-3.35|0.82||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||0.82|-3.35|= 0.2348
91698356|NCT02783729|183291380|SUPERIORITY||LSM Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.067|=|0.2745|TWO_SIDED|95.0|-3.26|0.93||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||0.93|-3.26|= 0.2745
91698357|NCT02783729|183291380|SUPERIORITY||LSM Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.005|=|0.711|TWO_SIDED|95.0|-2.35|1.6||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||1.6|-2.35|= 0.711
91698358|NCT02783729|183291380|SUPERIORITY||LSM Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.009|=|0.7854|TWO_SIDED|95.0|-2.26|1.71||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||1.71|-2.26|= 0.7854
91698359|NCT02783729|183291381|SUPERIORITY||LSM Difference|30.77|STANDARD_ERROR_OF_MEAN|12.505|=|0.0141|TWO_SIDED|95.0|6.23|55.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 5 mg||55.31|6.23|= 0.0141
91698360|NCT02783729|183291381|SUPERIORITY||LSM Difference|39.67|STANDARD_ERROR_OF_MEAN|12.542|=|0.0016|TWO_SIDED|95.0|15.05|64.29||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 10 mg||64.29|15.05|= 0.0016
91698361|NCT02783729|183291381|SUPERIORITY||LSM Difference|-19.22|STANDARD_ERROR_OF_MEAN|11.779|=|0.1031|TWO_SIDED|95.0|-42.34|3.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 5 mg||3.9|-42.34|= 0.1031
91698362|NCT02783729|183291381|SUPERIORITY||LSM Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.813|=|0.3825|TWO_SIDED|95.0|-33.5|12.86||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 10 mg||12.86|-33.5|= 0.3825
91698363|NCT02783729|183291381|SUPERIORITY||LSM Difference|28.81|STANDARD_ERROR_OF_MEAN|60.626|=|0.6348|TWO_SIDED|95.0|-90.18|147.8||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 5 mg||147.8|-90.18|= 0.6348
91698364|NCT02783729|183291381|SUPERIORITY||LSM Difference|50.83|STANDARD_ERROR_OF_MEAN|60.702|=|0.4026|TWO_SIDED|95.0|-68.3|169.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 10 mg||169.97|-68.3|= 0.4026
91730212|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4645|||||||Chi-square or Fisher exact|||Week 16||||0.4645
91730213|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2744|||||||Chi-square or Fisher exact|||Week 20||||0.2744
91730214|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7026|||||||Chi-square or Fisher exact|||Week 20||||0.7026
91730215|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7817|||||||Chi-square or Fisher exact|||Week 24||||0.7817
91698365|NCT02783729|183291381|SUPERIORITY||LSM Difference|-203.36|STANDARD_ERROR_OF_MEAN|57.171|=|0.0004|TWO_SIDED|95.0|-315.56|-91.15||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 5 mg||-91.15|-315.56|= 0.0004
91698366|NCT02783729|183291381|SUPERIORITY||LSM Difference|-181.33|STANDARD_ERROR_OF_MEAN|57.255|=|0.0016|TWO_SIDED|95.0|-293.71|-68.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 10 mg||-68.96|-293.71|= 0.0016
91698367|NCT02783729|183291382|SUPERIORITY||LSM Difference|-0.03|STANDARD_ERROR_OF_MEAN|4.141|=|0.9936|TWO_SIDED|95.0|-8.16|8.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 5 mg||8.09|-8.16|= 0.9936
91698368|NCT02783729|183291382|SUPERIORITY||LSM Difference|-5.85|STANDARD_ERROR_OF_MEAN|4.154|=|0.1595|TWO_SIDED|95.0|-14.0|2.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 10 mg||2.3|-14|= 0.1595
91698369|NCT02783729|183291382|SUPERIORITY||LSM Difference|12.73|STANDARD_ERROR_OF_MEAN|3.894|=|0.0011|TWO_SIDED|95.0|5.09|20.38||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 5 mg||20.38|5.09|= 0.0011
91698370|NCT02783729|183291382|SUPERIORITY||LSM Difference|6.92|STANDARD_ERROR_OF_MEAN|3.913|=|0.0774|TWO_SIDED|95.0|-0.76|14.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 10 mg||14.6|-0.76|= 0.0774
91698371|NCT02783729|183291382|SUPERIORITY||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.393|=|0.3726|TWO_SIDED|95.0|-0.42|1.12||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 5 mg||1.12|-0.42|= 0.3726
91698372|NCT02783729|183291382|SUPERIORITY||LSM Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.394|=|0.2579|TWO_SIDED|95.0|-1.22|0.33||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 10 mg||0.33|-1.22|= 0.2579
91698373|NCT02783729|183291382|SUPERIORITY||LSM Difference|1.39|STANDARD_ERROR_OF_MEAN|0.37|=|0.0002|TWO_SIDED|95.0|0.66|2.11||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 5 mg||2.11|0.66|= 0.0002
91730216|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.9285|||||||Chi-square or Fisher exact|||Week 24||||0.9285
91698374|NCT02783729|183291382|SUPERIORITY||LSM Difference|0.59|STANDARD_ERROR_OF_MEAN|0.372|=|0.112|TWO_SIDED|95.0|-0.14|1.32||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 10 mg||1.32|-0.14|= 0.112
91698375|NCT03421145|183291388|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91698376|NCT03421145|183291389|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91698377|NCT03421145|183291390|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91698378|NCT03421145|183291391|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91698379|NCT03421145|183291392|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91698380|NCT00474201|183291394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|Students paired, two-tailed T-test||"Null hypothesis: lopinavir-ritonavir does not alter gemfibrozil pharmacokinetics.~A sample size of 13 healthy subjects yielded 81% power to detect a clinically relevant change of 30% in gemfibrozil AUC with concomitant lopinavir-ritonavir (alpha = 0.05; beta = 0.2). Gemfibrozil pharmacokinetic parameters derived pre- and post lopinavir-ritonavir exposure (Days 1 and 14, respectively) were compared using a paired Students t test."||||<0.0001
91698381|NCT00750139|183291397|SUPERIORITY_OR_OTHER|||||||0.01||||||The first primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025.|Cochran-Mantel-Haenszel|||"The first primary efficacy hypotheses tests are:~H01: p1 ≤ p01 vs. H1: p1 \> p01 where p01 and p1 denote the proportions of complete cure in the placebo 2wks and NAFT-500 groups, respectively."||||0.010
91698382|NCT00750139|183291397|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025|Cochran-Mantel-Haenszel|||"The second primary efficacy hypotheses tests are:~H02: p2 ≤ P02 vs. H2: P2 \> p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively"||||0.001
91698383|NCT01082211|183291447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Chi-squared|||Assuming a 3-year rate of 25% using a chi-squared test, a sample size of 55 patients will ensure at least 90% probability of detecting a reduction in the 3-year ipsilateral in-breast recurrence rate from 25% to 9%, with a significance level of 0.05 (1-sided). In-breast recurrence will be estimated using the cumulative incidence method.||||0.0002
91698384|NCT01082211|183291455|OTHER||Effect size|0.1|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
91698385|NCT01082211|183291455|OTHER||Effect size|0.14|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
91698386|NCT01082211|183291455|OTHER||Effect size|0.34|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
91698387|NCT01082211|183291456|OTHER||Effect size|0.04|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
91698388|NCT01082211|183291456|OTHER||Effect size|0.32|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
91698389|NCT01082211|183291456|OTHER||Effect size|0.28|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
91698390|NCT01082211|183291458|OTHER|||||||0.054|||||||Spearman rank-order correlation test|||||||0.054
91698391|NCT01082211|183291458|OTHER|||||||0.044|||||||Spearman rank-order correlation test|||||||0.044
91698392|NCT01082211|183291458|OTHER|||||||0.087|||||||Spearman rank-order correlation test|||||||0.087
91698393|NCT04338269|183291480|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7844|TWO_SIDED|95.0|0.83|1.28|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.28|0.83|0.7844
91698394|NCT04338269|183291480|OTHER||Hazard Ratio (HR)|1.04||||0.7195|TWO_SIDED|95.0|0.84|1.29|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|Cox Proportional Hazards Model||1.29|0.84|0.7195
91698395|NCT04338269|183291481|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|0.94||||0.6902|TWO_SIDED|95.0|0.7|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.70|0.6902
91698396|NCT04338269|183291481|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|0.96||||0.7853||95.0|0.71|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.71|0.7853
91698397|NCT04338269|183291482|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.8037|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.83|0.8037
91698398|NCT04338269|183291482|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7894|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.83|0.7894
91698399|NCT04338269|183291483|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|-3.68||||0.4306|TWO_SIDED|95.0|-12.45|5.1|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||5.10|-12.45|0.4306
91698400|NCT04338269|183291484|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.7|1.43|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||1.43|0.70|0.9893
91698401|NCT04338269|183291485|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.7||||0.0816|TWO_SIDED|95.0|0.47|1.05|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.05|0.47|0.0816
91698402|NCT04338269|183291485|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.72||||0.1099||95.0|0.49|1.08|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.08|0.49|0.1099
91698403|NCT04338269|183291486|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.04||||0.8354|TWO_SIDED|95.0|0.7|1.54|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.54|0.70|0.8354
91698404|NCT04338269|183291486|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.05||||0.8159|TWO_SIDED|95.0|0.71|1.55|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.55|0.71|0.8159
91698405|NCT00174967|183291487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698406|NCT00174967|183291487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91730217|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 38||||0.0135
91698407|NCT00174967|183291487|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698408|NCT00174967|183291488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698409|NCT00174967|183291488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698410|NCT00174967|183291488|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91730218|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6992|||||||Chi-square or Fisher exact|||Week 38||||0.6992
91698411|NCT00174967|183291489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698412|NCT00174967|183291489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91759121|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1639
91698413|NCT00174967|183291489|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698414|NCT00174967|183291490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698415|NCT00174967|183291490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698416|NCT00174967|183291490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
91698417|NCT00174967|183291491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698418|NCT00174967|183291491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91491750|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|0.9||||0.819|TWO_SIDED|95.0|-6.7|8.5|||Mixed Models Analysis|||Before Evening Meal Glucose||8.5|-6.7|0.819
91491751|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|2.3||||0.588|TWO_SIDED|95.0|-6.2|10.9|||Mixed Models Analysis|||2 Hours After Evening Meal Glucose||10.9|-6.2|0.588
91698419|NCT00174967|183291491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698420|NCT00174967|183291492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698421|NCT00174967|183291492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698422|NCT00174967|183291492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698423|NCT00174967|183291493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698424|NCT00174967|183291493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91730219|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 52||||0.0135
91698425|NCT00174967|183291493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698426|NCT00174967|183291494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698427|NCT00174967|183291494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698428|NCT00174967|183291494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698429|NCT00174967|183291495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698430|NCT00174967|183291495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91730220|NCT04250207|183355747|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5154|||||||Chi-square or Fisher exact|||Week 52||||0.5154
91730221|NCT04250207|183355748|SUPERIORITY|||||||0.1209|||||||Log Rank|||||||0.1209
91730222|NCT04250207|183355748|SUPERIORITY|||||||0.7116|||||||Log Rank|||||||0.7116
91759122|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.1738|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1738
91759123|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0401
91698431|NCT00174967|183291495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698432|NCT00174967|183291496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698433|NCT00174967|183291496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698434|NCT00174967|183291496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
91698435|NCT02730377|183291499|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.||||<.0001
91698436|NCT03917472|183291539|SUPERIORITY|(1-sided)|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.89||0.099|TWO_SIDED|95.0|-0.6|2.9|||ANOVA|||||2.9|-0.6|0.099
91698437|NCT03917472|183291539|NON_INFERIORITY|(4-letter margin) (1-sided)|||||<|0.001|||||||ANOVA|||||||<0.001
91698438|NCT03917472|183291540|SUPERIORITY|(1-sided); Week 52|LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|8.94|<|0.001|TWO_SIDED|95.0|-58.9|-23.8|||ANOVA|||||-23.8|-58.9|<0.001
91698439|NCT03917472|183291541|SUPERIORITY|(1-sided) Week 52|Difference - %|20.0|||<|0.001|TWO_SIDED|95.0|12.5|28.6|||Clopper-Pearson exact method.|||||28.6|12.5|<0.001
91698440|NCT03917472|183291548|OTHER|Descriptive|Difference - %|9.3|||||TWO_SIDED|95.0|1.7|17.0|||Clopper-Pearson exact method|||≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|1.7|
91759124|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.2753|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.2753
91698441|NCT03917472|183291548|OTHER|Descriptive|Difference - %|7.7|||||TWO_SIDED|95.0|-1.5|17.0|||Clopper-Pearson exact method|||≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|-1.5|
91698442|NCT03917472|183291548|OTHER|Descriptive|Difference - %|5.5|||||TWO_SIDED|95.0|-2.7|14.3|||Clopper-Pearson exact method|||≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52||14.3|-2.7|
91698443|NCT03917472|183291549|OTHER|descriptive; week 12|Difference - %|8.3|||||TWO_SIDED|95.0|0.2|16.5|||Clopper-Pearson exact method|||||16.5|0.2|
91698444|NCT03917472|183291549|OTHER|descriptive; week 24|Difference - %|6.0|||||TWO_SIDED|95.0|-3.0|14.9|||Clopper-Pearson exact method|||||14.9|-3.0|
91698445|NCT03917472|183291549|NON_INFERIORITY|(10% margin); week 52|Difference - %|6.0||||0.002|TWO_SIDED|95.0|-3.9|16.1||(10% margin) (1-sided)|Clopper-Pearson exact method|||||16.1|-3.9|0.002
91698446|NCT03917472|183291550|OTHER|descriptive; week 12|Difference - %|2.0|||||TWO_SIDED|95.0|-2.5|6.6|||Clopper-Pearson exact method|||||6.6|-2.5|
91698447|NCT03917472|183291550|OTHER|descriptive; week 24|Difference - %|2.4|||||TWO_SIDED|95.0|-3.0|7.7|||Clopper-Pearson exact method|||||7.7|-3.0|
91698448|NCT03917472|183291550|OTHER|descriptive; week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.0|9.8|||Clopper-Pearson exact method|||||9.8|-2.0|
91730223|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0915|||||||Chi-square or Fisher exact|||Week 3||||0.0915
91698449|NCT01154296|183291554|SUPERIORITY_OR_OTHER||adjusted risk ratio (aRR)|1.12|||||TWO_SIDED|95.0|0.94|1.33||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).||1.33|0.94|
91698450|NCT01154296|183291555|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.09|0.90|
91698451|NCT01154296|183291556|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.98|||||TWO_SIDED|95.0|0.86|1.13|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.13|0.86|
91698452|NCT01154296|183291557|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.88|||||TWO_SIDED|95.0|0.82|0.94|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||0.94|0.82|
91491752|NCT03338010|182856353|SUPERIORITY||LS Mean Difference|1.4||||0.732|TWO_SIDED|95.0|-6.7|9.5|||Mixed Models Analysis|||Bedtime Glucose||9.5|-6.7|0.732
91698453|NCT01154296|183291558|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.05|0.90|
91730224|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3282|||||||Chi-square or Fisher exact|||Week 3||||0.3282
91730225|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0648|||||||Chi-square or Fisher exact|||Week 5||||0.0648
91698454|NCT01154296|183291559|SUPERIORITY_OR_OTHER||Adjusted Risk Ratio (aRR)|1.14||||||95.0|0.89|1.46||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||||1.46|0.89|
91698455|NCT04934189|183291570|OTHER||Mean Difference (Final Values)|0.295|STANDARD_DEVIATION|1.184||0.08|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.08
91491753|NCT03338010|182856354|SUPERIORITY|||||||0.846|||||||Fisher Exact|||||||0.846
91698456|NCT04934189|183291571|OTHER||Mean Difference (Net)|0.417|STANDARD_DEVIATION|0.89||0.005|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up mean) was statistically different from the baseline mean.||||.005
91698457|NCT04934189|183291573|OTHER||Mean Difference (Net)|-0.103|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||0.40
91730226|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.031|||||||Chi-square or Fisher exact|||Week 5||||0.0310
91730227|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0187|||||||Chi-square or Fisher exact|||Week 7||||0.0187
91730228|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0036|||||||Chi-square or Fisher exact|||Week 7||||0.0036
91730229|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0687|||||||Chi-square or Fisher exact|||Week 9||||0.0687
91730230|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0016|||||||Chi-square or Fisher exact|||Week 9||||0.0016
91730231|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0218|||||||Chi-square or Fisher exact|||Week 12||||0.0218
91730232|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0013|||||||Chi-square or Fisher exact|||Week 12||||0.0013
91730233|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0348|||||||Chi-square or Fisher exact|||Week 16||||0.0348
91491754|NCT03338010|182856355|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
91730234|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1028|||||||Chi-square or Fisher exact|||Week 16||||0.1028
91730235|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.8677|||||||Chi-square or Fisher exact|||Week 20||||0.8677
91491755|NCT03338010|182856356|SUPERIORITY||LS Mean Difference|0.32||||0.767|TWO_SIDED|95.0|-1.78|2.42|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||2.42|-1.78|0.767
91730236|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4401|||||||Chi-square or Fisher exact|||Week 20||||0.4401
91730237|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5926|||||||Chi-square or Fisher exact|||Week 24||||0.5926
91730238|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0732|||||||Chi-square or Fisher exact|||Week 24||||0.0732
91491756|NCT03338010|182856356|SUPERIORITY||LS Mean Difference|0.4||||0.781|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.3|-2.5|0.781
91491757|NCT03338010|182856357|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
91491758|NCT03338010|182856358|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
91491759|NCT03338010|182856359|SUPERIORITY||LS Mean Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-0.6|0.3|||Mixed Models Analysis|||||0.3|-0.6|<0.001
91491760|NCT03338010|182856360|SUPERIORITY||LS Mean Difference|-0.95||||0.5|TWO_SIDED|95.0|-3.72|1.82|||Mixed Models Analysis|||Inconvenience of Regimen Transformed Score||1.82|-3.72|0.500
91491761|NCT03338010|182856360|SUPERIORITY||LS Mean Difference|-3.99||||0.031|TWO_SIDED|95.0|-7.62|-0.36|||Mixed Models Analysis|||Lifestyle Flexibility Transformed Score||-0.36|-7.62|0.031
91698458|NCT04934189|183291574|OTHER||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|2.08||0.49|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up) mean was statistically different from the baseline mean.||||.49
91698459|NCT04934189|183291576|OTHER||Mean Difference (Net)|0.195|STANDARD_DEVIATION|1.41||0.21|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.21
91698460|NCT04934189|183291577|OTHER||Mean Difference (Net)|0.019|STANDARD_DEVIATION|1.43||0.47|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.47
91698461|NCT04934189|183291579|OTHER||Mean Difference (Net)|0.175|STANDARD_DEVIATION|1.02||0.16|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.16
91698462|NCT04934189|183291580|OTHER||Mean Difference (Net)|0.0481|STANDARD_DEVIATION|0.926||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.38
91698463|NCT04934189|183291582|OTHER||Mean Difference (Net)|0.179|STANDARD_DEVIATION|2.73||0.35|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.35
91698464|NCT04934189|183291583|OTHER||Mean Difference (Net)|-0.335|STANDARD_DEVIATION|2.05||0.17|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.17
91698465|NCT04934189|183291587|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|2.18||||0.02|ONE_SIDED|||||A priori threshold for statistical significance was \<.05|t-test, 1 sided|||||||.02
91698466|NCT04934189|183291587|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|1.29||||0.1|ONE_SIDED|||||A priori threshold for statistical significant was p \<.05|t-test, 1 sided|||||||.10
91698467|NCT04934189|183291587|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|0.17||||0.43|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.43
91730239|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2497|||||||Chi-square or Fisher exact|||Week 38||||0.2497
91730240|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2453|||||||Chi-square or Fisher exact|||Week 38||||0.2453
91730241|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
91730242|NCT04250207|183355749|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
91730243|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0093|||||||Chi-square or Fisher exact|||Week 3||||0.0093
91759125|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0056
91759126|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1173
91759127|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0268
91698468|NCT04934189|183291587|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|-0.68||||0.25|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.25
91698469|NCT04934189|183291587|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.36||||0.36|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.36
91698470|NCT04934189|183291587|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for pride was statistically different from the baseline mean.|t-test|-0.09||||0.47|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.47
91698471|NCT04934189|183291588|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|3.76|||<|0.001|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided||||"A series of one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean for each of the five gender minority stress subscales measured. See below for T-scores and associated p-values for each statistical test.~Nonaffirmation (t = 3.76; p = .001) Internalized Transphobia (t = 2.01; p = .02) Negative Expectations (t = 2.06; p =.02) Community Connection (t = -0.82; p =.21) Pride (t = .01; p = .50 )"|||<.001
91698472|NCT04934189|183291588|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|2.01||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance is p \< .05|t-test, 1 sided|||||||.02
91698473|NCT04934189|183291588|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|1.61||||0.06|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.06
91698474|NCT04934189|183291588|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|2.06||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.02
91698475|NCT04934189|183291588|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.818||||0.21|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.21
91698476|NCT04934189|183291588|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for pride was statistically different from the baseline mean.|t-test|0.009||||0.5|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.50
91698477|NCT04934189|183291591|OTHER||Chi-squared|5.59||||0.04|TWO_SIDED|||||A priori threshold for statistical significance was p \<.05|Chi-squared|||For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting freedom from sexual victimization over a 6 month time period||||.04
91698478|NCT04934189|183291591|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting any exposure to nonpenetrative sexual assault over a 6 month time period|Chi-squared|0.21||||0.55|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.55
91698479|NCT04934189|183291591|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting exposure to rape over a 6 month time period|Chi-squared|0.11||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.59
91698480|NCT04934189|183291593|OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|1.68||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.38
91698481|NCT04934189|183291594|OTHER||Mean Difference (Net)|-0.265|STANDARD_DEVIATION|2.21||0.25|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month) mean was statistically different from the baseline mean.||||.25
91698482|NCT01194999|183291595|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No significant difference from baseline to final follow-up.||||0.001
91698483|NCT03834974|183291608|SUPERIORITY||||||<|0.0286|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in intent to tan outdoors 10 or more times in the next year.||||<0.0286
91698484|NCT03834974|183291608|SUPERIORITY|||||||0.0937|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in in intent to tan later in life.||||0.0937
91698485|NCT03834974|183291612|SUPERIORITY||||||<|0.0002|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in tanning outside at follow-up||||<0.0002
91698486|NCT03330262|183291652|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
91698487|NCT03330262|183291653|OTHER|Ho: mean change = 0||||||0.006|||||||Mixed Models Analysis|||||||0.006
91698488|NCT03330262|183291653|OTHER|Ho: mean change = 0||||||0.869|||||||Mixed Models Analysis|||||||0.869
91698489|NCT03330262|183291654|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||||||0.448
91698490|NCT03330262|183291655|OTHER|This test evaluated whether the change in ABC was significant for the BALCAP condition##. Ho: mean = 0||||||0.273|||||||Mixed Models Analysis|||||||0.273
91698491|NCT03330262|183291655|OTHER|This test evaluated if the change in ABC score was significant for the control group.||||||0.796|||||||Mixed Models Analysis|||||||0.796
91698492|NCT03330262|183291656|OTHER|Ho: Mean change in score = 0||||||0.189|||||||Mixed Models Analysis|||||||0.189
91698493|NCT03330262|183291656|OTHER|Ho: mean change = 0||||||0.713|||||||Mixed Models Analysis|||||||0.713
91698494|NCT01647516|183291677|SUPERIORITY||Odds Ratio (OR)|3.262||||0.0482|TWO_SIDED|95.0|0.969|10.984|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||10.984|0.969|0.0482
91698495|NCT01647516|183291677|SUPERIORITY||Odds Ratio (OR)|2.5||||0.1422|TWO_SIDED|95.0|0.722|8.661|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||8.661|0.722|0.1422
91698496|NCT01647516|183291678|SUPERIORITY||Odds Ratio (OR)|2.158||||0.0207|TWO_SIDED|95.0|1.093|4.263|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||4.263|1.093|0.0207
91698497|NCT01647516|183291678|SUPERIORITY||Odds Ratio (OR)|1.947||||0.0648|TWO_SIDED|95.0|0.961|3.946|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||3.946|0.961|0.0648
91698498|NCT01647516|183291679|SUPERIORITY|||||||0.0042|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.0042
91698499|NCT01647516|183291679|SUPERIORITY|||||||0.1415|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.1415
91698500|NCT01647516|183291680|SUPERIORITY||Odds Ratio (OR)|3.861||||0.0023|TWO_SIDED|95.0|1.572|9.484|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||9.484|1.572|0.0023
91698501|NCT01647516|183291680|SUPERIORITY||Odds Ratio (OR)|2.647||||0.0348|TWO_SIDED|95.0|1.058|6.621|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||6.621|1.058|0.0348
91698502|NCT01647516|183291681|SUPERIORITY||Odds Ratio (OR)|4.332||||0.0108|TWO_SIDED|95.0|1.323|14.186|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||14.186|1.323|0.0108
91698503|NCT01647516|183291681|SUPERIORITY||Odds Ratio (OR)|5.443||||0.0021|TWO_SIDED|95.0|1.706|17.365|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||17.365|1.706|0.0021
91698504|NCT01647516|183291682|SUPERIORITY|Stratified by prior anti-TNF therapy experience, (yes or no).|Odds Ratio (OR)|4.03||||0.0002|TWO_SIDED|95.0|1.871|8.678|||Cochran-Mantel-Haenszel|||||8.678|1.871|0.0002
91698505|NCT01647516|183291682|SUPERIORITY||Odds Ratio (OR)|2.154||||0.0571|TWO_SIDED|95.0|0.974|4.763|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||4.763|0.974|0.0571
91528439|NCT00708305|182932217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.0726|TWO_SIDED|95.0|0.0|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.00|0.0726
91528440|NCT00708305|182932217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.03|<0.0001
91528441|NCT00708305|182932217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0107|TWO_SIDED|95.0|0.01|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.01|0.0107
91528442|NCT00708305|182932217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|||<|0.0001|TWO_SIDED|95.0|0.03|0.07|||Wilcoxon Signed Rank Test|No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.03|<0.0001
91528443|NCT00708305|182932217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0012|TWO_SIDED|95.0|0.01|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.01|0.0012
91730244|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 3||||> 0.9999
91730245|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0006|||||||Chi-square or Fisher exact|||Week 5||||0.0006
91528444|NCT04711460|182932218|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.003|STANDARD_DEVIATION|5.59||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||||0.003
91730246|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3449|||||||Chi-square or Fisher exact|||Week 5||||0.3449
91730247|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
91730248|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
91730249|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0001|||||||Chi-square or Fisher exact|||Week 9||||0.0001
91528445|NCT04711460|182932218|SUPERIORITY|The threshold for statistical significance was set at p=0.05. No power analysis was conducted.|Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|5.59||0.009|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.009
91698506|NCT01647516|183291683|SUPERIORITY||Odds Ratio (OR)|3.557||||0.0046|TWO_SIDED|95.0|1.444|8.762|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.762|1.444|0.0046
91698507|NCT01647516|183291683|SUPERIORITY||Odds Ratio (OR)|3.428||||0.0064|TWO_SIDED|95.0|1.384|8.494|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.494|1.384|0.0064
91698508|NCT03886519|183291687|SUPERIORITY||Odds Ratio (OR)|0.73||||0.07|TWO_SIDED|95.0|0.52|1.03||The a priori threshold for statistical significance is \<0.05.|Regression, Logistic|Adjusted for correlation between 2 eyes of a participant and baseline trichiasis severity.||||1.03|0.52|0.07
91698509|NCT04964544|183291695|OTHER||Percentage|90.7|||||TWO_SIDED|95.0|88.9|92.3|||||Proportion of participants|Proportion of participants with overall correct initial TASS assessment, with mitigations, worst case imputation (Self-Selection Population)||92.3|88.9|
91698510|NCT04964544|183291696|OTHER||Percentage|98.1|||||TWO_SIDED|95.0|97.1|98.8|||||Proportion of participants|Proportion of participants with overall correct final TASS assessment, with mitigations, worst case imputation (Per Protocol Population)||98.8|97.1|
91698511|NCT04964544|183291697|OTHER||Mean percent change from paseline|-35.48|||||TWO_SIDED|95.0|-36.63|-34.33||||||||-34.33|-36.63|
91698512|NCT04143594|183291730|SUPERIORITY||Difference in percentage|-2.6||||0.7178|TWO_SIDED|95.0|-18.4|13.2||P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||13.2|-18.4|0.7178
91730250|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 9||||0.0028
91730251|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 12||||< 0.0001
91730252|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 12||||0.0028
91698513|NCT04143594|183291730|SUPERIORITY||Difference in percentage|-7.1||||0.39|TWO_SIDED|95.0|-23.4|9.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.3|-23.4|0.3900
91698514|NCT04143594|183291730|SUPERIORITY||Difference in percentage|-7.2||||0.3797|TWO_SIDED|95.0|-23.5|9.1||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.1|-23.5|0.3797
91730253|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 16||||< 0.0001
91730254|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0011|||||||Chi-square or Fisher exact|||Week 16||||0.0011
91730255|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0094|||||||Chi-square or Fisher exact|||Week 20||||0.0094
91730256|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1281|||||||Chi-square or Fisher exact|||Week 20||||0.1281
91730257|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0051|||||||Chi-square or Fisher exact|||Week 24||||0.0051
91730258|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1313|||||||Chi-square or Fisher exact|||Week 24||||0.1313
91730259|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0268|||||||Chi-square or Fisher exact|||Week 38||||0.0268
91730260|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3652|||||||Chi-square or Fisher exact|||Week 38||||0.3652
91730261|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1854|||||||Chi-square or Fisher exact|||Week 52||||0.1854
91730262|NCT04250207|183355750|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
91730263|NCT04250207|183355751|SUPERIORITY|||||||0.0259|||||||Wilcoxon Rank Sum Test|||||||0.0259
91730264|NCT04250207|183355751|SUPERIORITY|||||||0.0068|||||||Wilcoxon Rank Sum Test|||||||0.0068
91730265|NCT04250207|183355752|SUPERIORITY|||||||0.4435|||||||Wilcoxon Rank Sum Test|||Week 1||||0.4435
91491762|NCT03338010|182856360|SUPERIORITY||LS Mean Difference|-1.79||||0.2|TWO_SIDED|95.0|-4.53|0.95|||Mixed Models Analysis|||Hypoglycemic Control Transformed Score||0.95|-4.53|0.200
91698515|NCT04143594|183291731|SUPERIORITY||Difference in percentage|-5.5||||0.2398|TWO_SIDED|95.0|-15.9|4.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.8|-15.9|0.2398
91698516|NCT04143594|183291731|SUPERIORITY||Difference in percentage|-7.4||||0.1639|TWO_SIDED|95.0|-18.3|3.4||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||3.4|-18.3|0.1639
91698517|NCT04143594|183291731|SUPERIORITY||Difference in percentage|-5.7||||0.2307|TWO_SIDED|95.0|-16.3|4.9||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.9|-16.3|0.2307
91698518|NCT04143594|183291732|SUPERIORITY||Difference in percentage|-6.7||||0.3142|TWO_SIDED|95.0|-20.7|7.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||7.3|-20.7|0.3142
91698519|NCT04143594|183291732|SUPERIORITY||Difference in percentage|-7.2||||0.3009|TWO_SIDED|95.0|-21.3|6.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.8|-21.3|0.3009
91698520|NCT04143594|183291732|SUPERIORITY||Difference in percentage|-7.6||||0.2859|TWO_SIDED|95.0|-21.8|6.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.7|-21.8|0.2859
91698521|NCT04143594|183291733|SUPERIORITY||Difference in percentage|-7.1||||0.3686|TWO_SIDED|95.0|-23.2|9.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.0|-23.2|0.3686
91698522|NCT04143594|183291733|SUPERIORITY||Difference in percentage|-16.5||||0.0887|TWO_SIDED|95.0|-34.0|1.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||1.0|-34.0|0.0887
91491763|NCT03338010|182856360|SUPERIORITY||LS Mean Difference|-0.02||||0.988|TWO_SIDED|95.0|-2.92|2.88|||Mixed Models Analysis|||Glycemic Control Transformed Score||2.88|-2.92|0.988
91491764|NCT03338010|182856360|SUPERIORITY||LS Mean Difference|-1.45||||0.337|TWO_SIDED|95.0|-4.41|1.51|||Mixed Models Analysis|||Insulin Delivery Device Satisfaction Transformed Score||1.51|-4.41|0.337
91491765|NCT03338010|182856360|SUPERIORITY||LS Mean Difference|-1.67||||0.205|TWO_SIDED|95.0|-4.26|0.92|||Mixed Models Analysis|||ITSQ Overall Total||0.92|-4.26|0.205
91698523|NCT04143594|183291733|SUPERIORITY||Difference in percentage|-5.4||||0.4949|TWO_SIDED|95.0|-21.5|10.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||10.7|-21.5|0.4949
91730266|NCT04250207|183355752|SUPERIORITY|||||||0.3402|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3402
91730267|NCT04250207|183355752|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
91730268|NCT04250207|183355752|SUPERIORITY|||||||0.0655|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0655
91730269|NCT04250207|183355752|SUPERIORITY|||||||0.0903|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0903
91730270|NCT04250207|183355752|SUPERIORITY|||||||0.0216|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0216
91730271|NCT04250207|183355752|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0020
91730272|NCT04250207|183355752|SUPERIORITY|||||||0.0676|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0676
91491766|NCT03338010|182856361|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
91491767|NCT03338010|182856362|SUPERIORITY||Relative Ratio|1.19||||0.143|TWO_SIDED|95.0|0.74|1.92|||Wilcoxon (Mann-Whitney)|||||1.92|0.74|0.143
91491768|NCT03338010|182856362|SUPERIORITY||Relative Ratio|1.22||||0.945|TWO_SIDED|95.0|0.67|2.23|||Wilcoxon (Mann-Whitney)|||||2.23|0.67|0.945
91491769|NCT00758836|182856363|SUPERIORITY_OR_OTHER||Proportion difference|24.5|||<|0.001|TWO_SIDED|90.0|16.7|32.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.||||32.2|16.7|<0.001
91491770|NCT00758836|182856363|SUPERIORITY_OR_OTHER||Proportion difference|27.7|||<|0.001|TWO_SIDED|90.0|19.6|35.8|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||35.8|19.6|<0.001
91730273|NCT04250207|183355752|SUPERIORITY|||||||0.0029|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0029
91730274|NCT04250207|183355752|SUPERIORITY|||||||0.0335|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0335
91730275|NCT04250207|183355752|SUPERIORITY|||||||0.0053|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0053
91730276|NCT04250207|183355752|SUPERIORITY|||||||0.0608|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0608
91730277|NCT04250207|183355752|SUPERIORITY|||||||0.0071|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0071
91698524|NCT04143594|183291734|SUPERIORITY||Difference in LSM|0.08||||0.5755|TWO_SIDED|95.0|-0.2|0.37||P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.37|-0.20|0.5755
91698525|NCT04143594|183291734|SUPERIORITY||Difference in LSM|0.02||||0.8697|TWO_SIDED|95.0|-0.25|0.29||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.29|-0.25|0.8697
91698526|NCT04143594|183291734|SUPERIORITY||Difference in LSM|0.06||||0.7052|TWO_SIDED|95.0|-0.23|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.23|0.7052
91698527|NCT04143594|183291735|SUPERIORITY||Difference in LSM|0.02||||0.8942|TWO_SIDED|95.0|-0.26|0.3||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.30|-0.26|0.8942
91698528|NCT04143594|183291735|SUPERIORITY||Difference in LSM|-0.02||||0.9058|TWO_SIDED|95.0|-0.28|0.25||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.25|-0.28|0.9058
91698529|NCT04143594|183291735|SUPERIORITY||Difference in LSM|0.04||||0.8129|TWO_SIDED|95.0|-0.27|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.27|0.8129
91730278|NCT04250207|183355752|SUPERIORITY|||||||0.4406|||||||Wilcoxon Rank Sum Test|||Week 16||||0.4406
91730279|NCT04250207|183355752|SUPERIORITY|||||||0.1716|||||||Wilcoxon Rank Sum Test|||Week 16||||0.1716
91730280|NCT04250207|183355752|SUPERIORITY|||||||0.9856|||||||Wilcoxon Rank Sum Test|||Week 20||||0.9856
91528446|NCT04711460|182932218|SUPERIORITY|The Tukey Kramer Post Hoc Test q value = 0.05 threshold|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.609|<|0.05|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Tukey Kramer Post-Hoc|Threshold of statistically significance was set at p=0.05.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||<0.05
91730281|NCT04250207|183355752|SUPERIORITY|||||||0.2229|||||||Wilcoxon Rank Sum Test|||Week 20||||0.2229
91730282|NCT04250207|183355752|SUPERIORITY|||||||0.8817|||||||Wilcoxon Rank Sum Test|||Week 24||||0.8817
91730283|NCT04250207|183355752|SUPERIORITY|||||||0.2081|||||||Wilcoxon Rank Sum Test|||||||0.2081
91730284|NCT04250207|183355752|SUPERIORITY|||||||0.7335|||||||Wilcoxon Rank Sum Test|||Week 38||||0.7335
91730285|NCT04250207|183355752|SUPERIORITY|||||||0.5367|||||||Wilcoxon Rank Sum Test|||Week 38||||0.5367
91730286|NCT04250207|183355752|SUPERIORITY|||||||0.555|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5550
91730287|NCT04250207|183355752|SUPERIORITY|||||||0.8718|||||||Wilcoxon Rank Sum Test|||Week 52||||0.8718
91730288|NCT05263791|183355757|NON_INFERIORITY|The primary objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR.|||||<|0.001|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -3, In the target of p\<0.05 indicates significance.||||<0.001
91730289|NCT05263791|183355758|NON_INFERIORITY|The hypothesis tested is demonstrated airRR non-inferior to acoRR when the capnostream is less sensitive.|||||<|0.001|||||||Paired t Test|||"In this study, a non-inferiority test was conducted during periods of reduced sensitivity in capnography to compare respiratory rate measurements using the Airmod device (airRR) versus manually scored auscultation sounds (referred to as acoRR, implying manARR in the statistical analysis plan). The research physician identified periods of reduced sensitivity in capnography."||||<0.001
91730290|NCT05263791|183355760|SUPERIORITY|This analysis were examined to assess the responsiveness of Airmod and Capnography.|||||<|0.001|||||||Paired t Test|||The hypothesis tested whether the response times obtained with the Airmod device were equal to those recorded with Capnography.||||<0.001
91698530|NCT04143594|183291736|SUPERIORITY||Difference in LSM|0.04||||0.7864|TWO_SIDED|95.0|-0.25|0.33||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.33|-0.25|0.7864
91730291|NCT05263791|183355761|NON_INFERIORITY|The objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR by subjects.|||||<|0.05|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -2, In the target of p\<0.05 indicates significance.||||<0.05
91730292|NCT04135443|183355813|SUPERIORITY||Odds Ratio (OR)|1.027||||0.94|TWO_SIDED|95.0|0.511|2.063|||Regression, Logistic|||||2.063|0.511|0.94
91730293|NCT04135443|183355815|SUPERIORITY||Slope|0.064||||0.455|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.455
91730294|NCT04135443|183355816|SUPERIORITY||Slope|0.026||||0.702|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.702
91730295|NCT04135443|183355817|SUPERIORITY||Slope|0.049||||0.375|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.375
91730296|NCT04135443|183355818|SUPERIORITY||Slope|0.076||||0.313|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.313
91730297|NCT04135443|183355819|SUPERIORITY||Slope|-0.01||||0.89|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.890
91730298|NCT02554474|183355839|SUPERIORITY||Adjusted difference in mean change|9.4|||||TWO_SIDED|95.0|-0.5|19.3||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||19.3|-0.5|
91730299|NCT02554474|183355840|SUPERIORITY||Adjusted difference in mean change|-10.4|||||TWO_SIDED|95.0|-53.4|32.6||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking.||32.6|-53.4|
91730300|NCT02554474|183355841|SUPERIORITY||Adjusted difference in mean change|-0.31|||||TWO_SIDED|95.0|-0.63|0.01||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking.||0.01|-0.63|
91730301|NCT02554474|183355842|SUPERIORITY||Adjusted difference in mean change|-2.45|||||TWO_SIDED|95.0|-4.78|-0.13||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking.||-0.13|-4.78|
91730302|NCT02554474|183355843|SUPERIORITY||Adjusted difference in mean change|-0.22|||||TWO_SIDED|95.0|-1.78|1.35||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||1.35|-1.78|
91730303|NCT02554474|183355844|SUPERIORITY||Adjusted difference in mean change|1.58|||||TWO_SIDED|95.0|-1.02|4.18||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||4.18|-1.02|
91730304|NCT02554474|183355845|SUPERIORITY||Adjusted difference in mean change|0.05|||||TWO_SIDED|95.0|-0.05|0.16||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.16|-0.05|
91730305|NCT02554474|183355846|SUPERIORITY||Adjusted difference in mean change|0.0|||||TWO_SIDED|95.0|-0.37|0.37||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.37|-0.37|
91730306|NCT02554474|183355847|SUPERIORITY||Adjusted difference in mean change|0.54|||||TWO_SIDED|95.0|0.08|0.99||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.99|0.08|
91730307|NCT02770365|183355859|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.14|||||TWO_SIDED|90.0|-2.92|12.53|||Wald's method|||||12.53|-2.92|
91730308|NCT02770365|183355860|EQUIVALENCE|the proportion of subjects with treatment success based on the improvement of the Most Bothersome Symptom (MBS) of vulvo-vaginal atrophy at Day 8.|equivalence ratio|0.94||||0.05|TWO_SIDED|90.0|-12.35|4.31|||Wald's method|||||4.31|-12.35|0.05
91730309|NCT00489476|183355878|SUPERIORITY|||||||0.0212|||||||Fisher Exact|||||||0.0212
91730310|NCT00489476|183355878|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
91730311|NCT00489476|183355879|SUPERIORITY|||||||0.0123|||||||Fisher Exact|||||||0.0123
91730312|NCT00489476|183355879|SUPERIORITY|||||||0.0228|||||||Fisher Exact|||||||0.0228
91730313|NCT00489476|183355880|SUPERIORITY|||||||0.0409|||||||Fisher Exact|||||||0.0409
91730314|NCT04003389|183355887|SUPERIORITY||LSMean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.0604|TWO_SIDED|95.0|-0.36|0.21||LSM, SE, CI, \& p-values come from an analysis of covariance (ANCOVA) model with change from baseline at Week 52 timepoint as response, treatment \& smoking status (current vs former/never) as fixed effects with baseline weight \& baseline as covariate.|ANCOVA|||LSMeans (LSM), standard errors (SE), confidence intervals (CI)||0.21|-0.36|0.0604
91730315|NCT04003389|183355887|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.45|0.11||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.11|-0.45|0.239
91730316|NCT04003389|183355889|SUPERIORITY||LSMean difference|0.007|STANDARD_ERROR_OF_MEAN|0.003||0.029|TWO_SIDED|95.0|0.001|0.014||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.014|0.001|0.029
91730317|NCT04003389|183355889|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.003||0.867|TWO_SIDED|95.0|-0.006|0.007||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.007|-0.006|0.867
91730318|NCT04003389|183355889|SUPERIORITY||LSMean difference|0.006|STANDARD_ERROR_OF_MEAN|0.003||0.027|TWO_SIDED|95.0|0.001|0.012||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.012|0.001|0.027
91730319|NCT04003389|183355889|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.003||0.41|TWO_SIDED|95.0|-0.003|0.008||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.008|-0.003|0.410
91730320|NCT04003389|183355889|SUPERIORITY||LSMean difference|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.087||95.0|-0.001|0.011||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.011|-0.001|0.087
91730321|NCT04003389|183355889|SUPERIORITY||LSMean difference|0.003|STANDARD_ERROR_OF_MEAN|0.003||0.259||95.0|-0.002|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.009|-0.002|0.259
91698531|NCT04143594|183291736|SUPERIORITY||Difference in LSM|-0.05||||0.7013|TWO_SIDED|95.0|-0.31|0.21||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.21|-0.31|0.7013
91698532|NCT04143594|183291736|SUPERIORITY||Difference in LSM|0.22||||0.2753|TWO_SIDED|95.0|-0.18|0.62||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.62|-0.18|0.2753
91491771|NCT00758836|182856363|SUPERIORITY_OR_OTHER||Proportion difference|20.4|||<|0.001|TWO_SIDED|90.0|12.6|28.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||28.2|12.6|<0.001
91491772|NCT00758836|182856363|SUPERIORITY_OR_OTHER||Proportion differenece|4.2||||0.449|TWO_SIDED|90.0|-5.0|13.3|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||13.3|-5.0|0.449
91698533|NCT04143594|183291737|SUPERIORITY||Difference in LSM|0.08||||0.564|TWO_SIDED|95.0|-0.19|0.34||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.34|-0.19|0.5640
91730322|NCT04003389|183355890|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.079|TWO_SIDED|95.0|-0.006|0.102||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.102|-0.006|0.079
91491773|NCT00758836|182856363|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.182|TWO_SIDED|90.0|-1.8|17.1|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||17.1|-1.8|0.182
91491774|NCT00758836|182856364|SUPERIORITY_OR_OTHER||Proportion difference|40.8|||<|0.001|TWO_SIDED|90.0|31.9|49.0|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||49.0|31.9|<0.001
91698534|NCT04143594|183291737|SUPERIORITY||Difference in LSM|-0.01||||0.9555|TWO_SIDED|95.0|-0.28|0.26||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.26|-0.28|0.9555
91698535|NCT04143594|183291737|SUPERIORITY||Difference in LSM|0.14||||0.4025|TWO_SIDED|95.0|-0.19|0.46||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.46|-0.19|0.4025
91698536|NCT04143594|183291738|SUPERIORITY||Difference in LSM|12.0||||0.7751|TWO_SIDED|95.0|-73.0|97.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||97|-73|0.7751
91698537|NCT04143594|183291738|SUPERIORITY||Difference in LSM|-2.0||||0.9549|TWO_SIDED|95.0|-79.0|75.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||75|-79|0.9549
91698538|NCT04143594|183291738|SUPERIORITY||Difference in LSM|44.0||||0.2603|TWO_SIDED|95.0|-33.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-33|0.2603
91698539|NCT04143594|183291739|SUPERIORITY||Difference in LSM|-31.0||||0.4827|TWO_SIDED|95.0|-119.0|57.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||57|-119|0.4827
91698540|NCT04143594|183291739|SUPERIORITY||Difference in LSM|-12.0||||0.7963|TWO_SIDED|95.0|-106.0|81.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||81|-106|0.7963
91698541|NCT04143594|183291739|SUPERIORITY||Difference in LSM|-22.0||||0.6169|TWO_SIDED|95.0|-111.0|67.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||67|-111|0.6169
91698542|NCT04143594|183291740|SUPERIORITY||Difference in LSM|21.0||||0.6614|TWO_SIDED|95.0|-73.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-73|0.6614
91698543|NCT04143594|183291740|SUPERIORITY||Difference in LSM|20.0||||0.6791|TWO_SIDED|95.0|-75.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-75|0.6791
91698544|NCT04143594|183291740|SUPERIORITY||Difference in LSM|27.0||||0.5563|TWO_SIDED|95.0|-65.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-65|0.5563
91730323|NCT04003389|183355890|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.98|TWO_SIDED|95.0|-0.052|0.053||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.053|-0.052|0.980
91698545|NCT04143594|183291741|SUPERIORITY||Difference in LSM|32.0||||0.5492|TWO_SIDED|95.0|-75.0|140.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||140|-75|0.5492
91698546|NCT04143594|183291741|SUPERIORITY||Difference in LSM|17.0||||0.722|TWO_SIDED|95.0|-80.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|Difference in LSM||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-80|0.7220
91698547|NCT04143594|183291741|SUPERIORITY||Difference in LSM|-4.0||||0.9486|TWO_SIDED|95.0|-118.0|110.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||110|-118|0.9486
91698548|NCT01023256|183291768|SUPERIORITY_OR_OTHER|||||||0.095||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.095
91730324|NCT04003389|183355890|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.023||0.042||95.0|0.002|0.094||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.094|0.002|0.042
91730325|NCT04003389|183355890|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.023||0.386||95.0|-0.025|0.065||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.065|-0.025|0.386
91759128|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.4406|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final||||0.4406
91698549|NCT01023256|183291768|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||<0.0001
91491775|NCT00758836|182856364|SUPERIORITY_OR_OTHER||Proportion difference|39.9|||<|0.001|TWO_SIDED|90.0|30.5|48.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||48.5|30.5|<0.001
91491776|NCT00758836|182856364|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.265|TWO_SIDED|90.0|-2.9|14.9|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.9|-2.9|0.265
91491777|NCT00758836|182856364|SUPERIORITY_OR_OTHER||Proportion difference|5.2||||0.362|TWO_SIDED|90.0|-4.2|14.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.5|-4.2|0.362
91491778|NCT00758836|182856364|SUPERIORITY_OR_OTHER||Proportion difference|34.7|||<|0.001|TWO_SIDED|90.0|25.3|43.4|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||43.4|25.3|<0.001
91491779|NCT00293033|182856367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.31|16.18|||Mixed Models Analysis|The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.|Onsolis minus placebo|||16.18|3.31|0.004
91491780|NCT00293033|182856368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.44|TWO_SIDED|95.0|-0.4|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|-0.40|0.440
91491781|NCT00293033|182856369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.7||0.179|TWO_SIDED|95.0|-0.44|2.33|||Mixed Models Analysis|||||2.33|-0.44|0.179
91491782|NCT00293033|182856370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.16||0.047|TWO_SIDED|95.0|0.04|4.61|||Mixed Models Analysis|||||4.61|0.04|0.047
91698550|NCT01023256|183291768|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
91698551|NCT01023256|183291770|SUPERIORITY_OR_OTHER|||||||0.421||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.421
91698552|NCT01023256|183291770|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
91730326|NCT04003389|183355890|SUPERIORITY||LSMean difference|0.041|STANDARD_ERROR_OF_MEAN|0.029||0.156||95.0|-0.016|0.099||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.099|-0.016|0.156
91730327|NCT04003389|183355890|SUPERIORITY||LSMean difference|0.028|STANDARD_ERROR_OF_MEAN|0.029||0.328|TWO_SIDED|95.0|-0.028|0.084||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.084|-0.028|0.328
91730328|NCT04003389|183355891|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.497||95.0|-0.005|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.009|-0.005|0.497
91730329|NCT04003389|183355891|SUPERIORITY||LSMean difference|-0.001|STANDARD_ERROR_OF_MEAN|0.004||0.878||95.0|-0.007|0.006||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.006|-0.007|0.878
91491783|NCT00293033|182856371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.68|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|8.5|30.86|||Mixed Models Analysis|||||30.86|8.50|<0.001
91491784|NCT00293033|182856372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|31.98|STANDARD_ERROR_OF_MEAN|8.23|<|0.001|TWO_SIDED|95.0|15.85|48.12|||Mixed Models Analysis|||||48.12|15.85|<0.001
91491785|NCT00293033|182856373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||||||0.517
91491786|NCT00293033|182856374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
91491787|NCT00293033|182856375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.223
91491788|NCT00293033|182856376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
91491789|NCT00293033|182856377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91491790|NCT00293033|182856378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91491791|NCT00293033|182856379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|||||||Wilcoxon (Mann-Whitney)|||||||0.193
91491792|NCT00293033|182856380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||||||0.113
91491793|NCT00293033|182856381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||Wilcoxon (Mann-Whitney)|||||||0.192
91491794|NCT00293033|182856382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91491795|NCT00293033|182856383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91491796|NCT00293033|182856384|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91491797|NCT00293033|182856385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
91491798|NCT00293033|182856386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
91491799|NCT00293033|182856387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
91491800|NCT00293033|182856388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91491801|NCT00293033|182856389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91491802|NCT00293033|182856390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91491803|NCT00293033|182856391|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91528447|NCT04711460|182932218|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.13||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.003
91528448|NCT04711460|182932218|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.07||0.454|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.454
91491804|NCT00293033|182856392|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91491805|NCT00293033|182856393|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91491806|NCT00293033|182856394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
91491807|NCT00293033|182856395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||||||0.498
91491808|NCT00293033|182856396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
91491809|NCT00293033|182856397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
91491810|NCT00293033|182856398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||Wilcoxon (Mann-Whitney)|||||||0.963
91491811|NCT00293033|182856399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91491812|NCT00293033|182856400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91491813|NCT00293033|182856401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91491814|NCT00293033|182856402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
91491815|NCT00293033|182856403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91491816|NCT00293033|182856404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91491817|NCT00293033|182856405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91491818|NCT00293033|182856406|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91491819|NCT00293033|182856407|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91491820|NCT00293033|182856408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
91491821|NCT00293033|182856409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91491822|NCT00293033|182856410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
91491823|NCT00293033|182856411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91491824|NCT00293033|182856412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91491825|NCT00293033|182856413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|2.57||0.023|TWO_SIDED|95.0|0.92|11.01|||Mixed Models Analysis|||||11.01|0.92|0.023
91491826|NCT00293033|182856414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.84|STANDARD_ERROR_OF_MEAN|7.25||0.009|TWO_SIDED|95.0|5.63|34.04|||Mixed Models Analysis|||||34.04|5.63|0.009
91491827|NCT00293033|182856415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.26|STANDARD_ERROR_OF_MEAN|12.72||0.012|TWO_SIDED|95.0|8.32|58.2|||Mixed Models Analysis|||||58.20|8.32|0.012
91491828|NCT00293033|182856416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|46.88|STANDARD_ERROR_OF_MEAN|18.46||0.015|TWO_SIDED|95.0|10.69|83.08|||Mixed Models Analysis|||||83.08|10.69|0.015
91491829|NCT01135420|182856458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
91491830|NCT00717197|182856459|SUPERIORITY_OR_OTHER||Percentage|21.7|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|7.46|43.7||||||||43.7|7.46|
91491831|NCT03003390|182856464|SUPERIORITY||Posterior probabilities|0.09|||||TWO_SIDED||||||||||Using informative priors of B(1, 1) on the enoxaparin arm and B(18, 82) on the usual care arm, the risks of CADVT were 0.32 (95% CrI: 0.16, 0.51) in the enoxaparin arm and 0.25 (95% CrI: 0.18, 0.33) in the usual care arm. The posterior probability that the absolute difference in the risk of CADVT was lower by 0.06 in the enoxaparin arm was 9.1%. Using minimally informative priors, the risk ratio of CADVT with enoxaparin was 0.55 (95% CrI: 0.24, 1.11).|||
91491832|NCT03003390|182856465|SUPERIORITY|||||||0.22|||||||Linear mixed effects model|||||||0.22
91491833|NCT03003390|182856466|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91491834|NCT03003390|182856467|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91491835|NCT03003390|182856468|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
91491836|NCT03003390|182856469|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91491837|NCT03003390|182856471|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
91491838|NCT03311724|182856535|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
91491839|NCT03311724|182856535|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||||-1.7|-2.8|<0.001
91491840|NCT03311724|182856535|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
91491841|NCT03311724|182856536|SUPERIORITY||Odds Ratio (OR)|56.54|||<|0.001|TWO_SIDED|95.0|9.43|338.97|||Regression, Logistic|||||338.97|9.43|<0.001
91698553|NCT01023256|183291770|SUPERIORITY_OR_OTHER|||||||0.065||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.065
91698554|NCT01023256|183291771|SUPERIORITY_OR_OTHER|||||||0.243||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included||||||0.243
91698555|NCT01023256|183291771|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values \< 0.05 were considered significant.|Fisher Exact|Patients with missing values were not included||||||<0.0001
91698556|NCT01023256|183291771|SUPERIORITY_OR_OTHER|||||||0.135||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included.||||||0.135
91491842|NCT03311724|182856536|SUPERIORITY||Odds Ratio (OR)|183.48|||<|0.001|TWO_SIDED|95.0|22.0|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|22.0|<0.001
91698557|NCT00308087|183291775|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||"Exact Conditional Test is stratified on the number~\> of prior therapies (1 or 2, 3 or more prior therapies)."|2-sided Exact Conditional Test|||||||0.6182
91730330|NCT04003389|183355892|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.031||0.527|TWO_SIDED|95.0|-0.042|0.082||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.082|-0.042|0.527
91730331|NCT04003389|183355892|SUPERIORITY||LSMean difference|-0.005|STANDARD_ERROR_OF_MEAN|0.031||0.872||95.0|-0.066|0.056||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.056|-0.066|0.872
91730332|NCT02514746|183355906|OTHER||Difference (Group A - B)|-0.6|||||TWO_SIDED|95.0|-7.5|4.5||||||Difference at Year 3||4.5|-7.5|
91730333|NCT02514746|183355906|OTHER||Difference (Group A - B)|0.6|||||TWO_SIDED|95.0|-7.4|6.5||||||Difference at Year 4||6.5|-7.4|
91698558|NCT00308087|183291778|SUPERIORITY_OR_OTHER|||||||0.5501||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.5501
91698559|NCT00308087|183291779|SUPERIORITY_OR_OTHER|||||||0.8217||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.8217
91698560|NCT01967706|183291781|OTHER||Geometric LS Mean Ratio|88.47|||||TWO_SIDED|95.0|68.64|114.03|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||114.03|68.64|
91698561|NCT01967706|183291782|OTHER||Geometric LS Mean Ratio|98.13|||||TWO_SIDED|95.0|80.61|119.46|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||119.46|80.61|
91730334|NCT02514746|183355907|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 3||1.1|0.9|
91491843|NCT03311724|182856536|SUPERIORITY||Odds Ratio (OR)|157.54|||<|0.001|TWO_SIDED|95.0|21.63|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|21.63|<0.001
91491844|NCT03311724|182856537|SUPERIORITY||Mean Difference (Final Values)|-48.5|||<|0.001|TWO_SIDED|95.0|-70.6|-26.3|||Mixed Models Analysis|||||-26.3|-70.6|<0.001
91698562|NCT01154088|183291783|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|5.42|||||TWO_SIDED|95.0|-1.41|12.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||12.25|-1.41|
91730335|NCT02514746|183355907|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 4||1.1|0.9|
91730336|NCT02514746|183355908|OTHER||Difference (Group A - B)|-3.7|||||TWO_SIDED|95.0|-8.1|2.8||||||Difference at 7 days post booster vaccination||2.8|-8.1|
91730337|NCT02514746|183355908|OTHER||Difference (Group A - B)|-1.3|||||TWO_SIDED|95.0|-3.3|3.0||||||Difference at 28 days post booster vaccination||3.0|-3.3|
91730338|NCT02514746|183355909|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.5|1.0||||||Geometric mean titer ratio 7 days after booster dose||1.0|0.5|
91730339|NCT02514746|183355909|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.6|0.9||||||Geometric mean titer ratio 28 days after booster dose||0.9|0.6|
91730340|NCT02514746|183355910|OTHER||Difference (Group A - B)|-2.9|||||TWO_SIDED|95.0|-8.0|4.5||||||Difference at 7 days post booster vaccination||4.5|-8.0|
91491845|NCT03311724|182856537|SUPERIORITY||Mean Difference (Final Values)|-58.0|||<|0.001|TWO_SIDED|95.0|-80.7|-35.2|||Mixed Models Analysis|||||-35.2|-80.7|<0.001
91491846|NCT03311724|182856537|SUPERIORITY||Mean Difference (Final Values)|-61.9|||<|0.001|TWO_SIDED|95.0|-84.6|-39.2|||Mixed Models Analysis|||||-39.2|-84.6|<0.001
91491847|NCT03311724|182856538|SUPERIORITY||Mean Difference (Final Values)|-4.8|||<|0.001|TWO_SIDED|95.0|-7.1|-2.6|||Mixed Models Analysis|||||-2.6|-7.1|<0.001
91698563|NCT01154088|183291783|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|-0.41|||||TWO_SIDED|95.0|-4.11|3.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||3.25|-4.11|
91698564|NCT01154088|183291783|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|6.83|||||TWO_SIDED|95.0|3.28|10.78||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||10.78|3.28|
91698565|NCT01154088|183291783|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|7.02|||||TWO_SIDED|95.0|2.63|11.58||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||11.58|2.63|
91491848|NCT03311724|182856538|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.2|-2.7|||Mixed Models Analysis|||||-2.7|-7.2|<0.001
91698566|NCT01154088|183291784|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.||1.17|0.92|
91698567|NCT01154088|183291784|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.15|||||TWO_SIDED|95.0|0.96|1.37||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.||1.37|0.96|
91491849|NCT03311724|182856538|SUPERIORITY||Mean Difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-7.5|-2.9|||Mixed Models Analysis|||||-2.9|-7.5|<0.001
91730341|NCT02514746|183355910|OTHER||Difference (Group A - B)|-1.8|||||TWO_SIDED|95.0|-4.4|3.0||||||Difference at 28 days post booster vaccination||3.0|-4.4|
91759129|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.7926|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional Well Being Final||||0.7926
91759130|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0987|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final||||0.0987
91759131|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final||||0.0361
91491850|NCT03311724|182856539|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.075|TWO_SIDED|95.0|-4.7|0.2|||Mixed Models Analysis|||||0.2|-4.7|0.075
91759132|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0615|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final||||0.0615
91759133|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0024
91759134|NCT01846741|183411302|SUPERIORITY_OR_OTHER|||||||0.0155|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0155
91759135|NCT01846741|183411304|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||3 months||||0.0625
91759136|NCT01846741|183411304|SUPERIORITY_OR_OTHER|||||||0.1094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||6 months||||0.1094
91759137|NCT01846741|183411304|SUPERIORITY_OR_OTHER|||||||0.0342|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||12 months||||0.0342
91759138|NCT01846741|183411304|SUPERIORITY_OR_OTHER|||||||0.5417|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||18 Months||||0.5417
91759139|NCT01399866|183411315|SUPERIORITY|||||||0.574|||||||ANOVA|||||||0.574
91491851|NCT03311724|182856539|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.065
91491852|NCT03311724|182856539|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.2|||Mixed Models Analysis|||||0.2|-4.9|0.065
91759140|NCT01399866|183411315|SUPERIORITY|||||||0.747|||||||ANOVA|||||||0.747
91698568|NCT01154088|183291784|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.||1.04|0.8|
91698569|NCT01154088|183291784|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.||0.99|0.78|
91698570|NCT02949843|183291808|OTHER|||||||0.6|||||||Fisher Exact|||Null Hypothesis is that each arm has equal rates of smoking history.||||0.6
91491853|NCT02955602|182856578|OTHER||||||=|0.2242|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 5 mg treatment groups after 8 weeks of treatment.||||= 0.2242
91698571|NCT05831644|183291809|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.1925|TWO_SIDED|90.0|-0.285|0.037|||ANOVA|||The primary endpoint (RHI score) was compared between treatments using an analysis of variance model (ANOVA) with treatment and period as fixed effects and subjects as random effect.||0.037|-0.285|0.1925
91698572|NCT05831644|183291810|SUPERIORITY||Mean Difference (Final Values)|-4.94||||0.1941|TWO_SIDED|90.0|-11.392|1.513|||ANOVA|||The secondary pharmacodynamic endpoint (AI) was analysed using a similar ANOVA model as for the primary endpoint.||1.513|-11.392|0.1941
91698573|NCT03085238|183291819|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.1309|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||0.1309
91698574|NCT03085238|183291820|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.0181|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||.0181
91698575|NCT00977314|183291881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|1.0|<|0.001|||||||t-test, 2 sided|||The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).||||<0.001
91698576|NCT00288600|183291893|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Chi-squared, Corrected|||Need of Exchange transfusion following the AAP criteria||||0.765
91698577|NCT03600194|183291920|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Design\*Therapy interaction term||||||.019
91698578|NCT00556933|183291923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||Chi-squared|||||||0.0004
91698579|NCT00556933|183291924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||General Linear Model|||||||0.45
91698580|NCT00556933|183291925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Fisher Exact|||||||0.53
91698581|NCT00556933|183291926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463|TWO_SIDED||||||Fisher Exact|||||||0.463
91698582|NCT00556933|183291927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Kaplan-Meier|||||||0.67
91698583|NCT00556933|183291928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Fisher Exact|||||||0.193
91698584|NCT00556933|183291929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|TWO_SIDED||||||Fisher Exact|||||||0.422
91698585|NCT00556933|183291930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871|TWO_SIDED||||||Fisher Exact|||||||0.871
91698586|NCT00556933|183291931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED||||||Kruskal-Wallis|||||||0.068
91698587|NCT00556933|183291932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
91698588|NCT00556933|183291933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
91698589|NCT00556933|183291934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Kruskal-Wallis|||||||0.40
91698590|NCT00746564|183291936|SUPERIORITY_OR_OTHER||percentage of recordings|100.0|||||TWO_SIDED|95.0|100.0|100.0||||||"The sensitivity was calculated for each recording and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|100|
91698591|NCT00746564|183291937|SUPERIORITY_OR_OTHER||percentage of clinical recordings|98.1|||||TWO_SIDED|95.0|95.7|100.0||||||"The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.7|
91698592|NCT00746564|183291938|SUPERIORITY_OR_OTHER||percentage of recordings|98.0|||||TWO_SIDED|95.0|95.5|100.0||||||"The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.5|
91698593|NCT00746564|183291939|SUPERIORITY_OR_OTHER||percentage of recordings|98.9|||||TWO_SIDED|95.0|96.7|100.0||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||100|96.7|
91759141|NCT01399866|183411316|SUPERIORITY|||||||0.94|||||||ANOVA|||||||0.94
91698594|NCT00746564|183291940|SUPERIORITY_OR_OTHER||percentage of recording|77.1|||||TWO_SIDED|95.0|65.9|88.4||||||"The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||88.4|65.9|
91698595|NCT00746564|183291941|SUPERIORITY_OR_OTHER||Percentage of recordings|85.0|||||TWO_SIDED|95.0|78.3|91.7||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||91.7|78.3|
91698596|NCT00746564|183291942|SUPERIORITY_OR_OTHER||percentage of interpretable recording|99.2|||||TWO_SIDED|95.0|98.5|100.0||||||"The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:~Duration (sec) of interpretable recording / Total duration of recording time (sec)"||100|98.5|
91698597|NCT00746564|183291943|SUPERIORITY_OR_OTHER||percentage of interpretable recording|92.3|||||TWO_SIDED|95.0|91.9|92.6||||||"The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:~Duration of interpretable recording / Total duration of recording time"||92.6|91.9|
91698598|NCT00746564|183291944|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|86.2|||||TWO_SIDED|95.0|79.4|91.0||||||||91.0|79.4|
91698599|NCT00746564|183291945|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|63.2|||||TWO_SIDED|95.0|48.1|76.2||||||||76.2|48.1|
91698600|NCT03689374|183291972|NON_INFERIORITY|The responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as a covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomized treatment, using a regression model including randomized treatment group and data from baseline and all previous visits as covariates. The prespecified non inferiority margin was 0.3%-point.|Treatment difference|-0.29|||<|0.0001|TWO_SIDED|95.0|-0.38|-0.2|||t-distributed test|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test.||||-0.20|-0.38|<0.0001
91759142|NCT01399866|183411317|SUPERIORITY|||||||0.818|||||||ANOVA|||||||0.818
91759143|NCT01399866|183411318|SUPERIORITY|||||||0.123|||||||ANOVA|||||||0.123
91759144|NCT01399866|183411319|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||||||0.473
91759145|NCT04146935|183411343|OTHER|Mixed model repeated measures||||||0.4147||||||Visit 1 (baseline) to visit 4 (peak)|Mixed Models Analysis|||||||0.4147
91759146|NCT04146935|183411344|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91759147|NCT04146935|183411345|OTHER|Mixed model repeated measures||||||0.6957|||||||Mixed Models Analysis|||||||0.6957
91759148|NCT04146935|183411346|OTHER|||||||0.0092|||||||Mixed Models Analysis|||||||0.0092
91759149|NCT04146935|183411347|OTHER|Mixed model repeated measures||||||0.1383|||||||Mixed Models Analysis|||||||0.1383
91759150|NCT04146935|183411348|OTHER|mixed model repeated measures||||||0.0572|||||||Mixed Models Analysis|||||||0.0572
91759151|NCT04038567|183411361|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-1.14|1.2||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.20|-1.14|
91759152|NCT04038567|183411361|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.39|-0.04||||||Values are change in model-estimated means for his vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.04|-2.39|
91491854|NCT02955602|182856578|OTHER||||||=|0.0021|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0021
91491855|NCT02955602|182856578|OTHER||||||=|0.0024|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 5 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0024
91528449|NCT04711460|182932219|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|7.194||0.002|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.002
91491856|NCT01581931|182856598|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.69|STANDARD_DEVIATION|9.7|||TWO_SIDED|95.0|93.63|101.94|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||101.94|93.63|
91698601|NCT00986921|183292008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.05|TWO_SIDED|95.0|0.0|3.0|||t-test, 1 sided|Data was not distributed normally. After log transformation, the log values were distributed normally.||||3|0|0.05
91491857|NCT01581931|182856601|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.76|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|93.64|102.07|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||102.07|93.64|
91491858|NCT01581931|182856602|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|98.79|STANDARD_DEVIATION|10.0|||TWO_SIDED|90.0|94.55|103.21|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||103.21|94.55|
91491859|NCT04666051|182856615|SUPERIORITY|Data from both groups has been collected compared to verify significant statistical difference||||||0.022|||||||Chi-squared|||||||0.022
91491860|NCT00980057|182856641|NON_INFERIORITY|The non-inferiority margin was 12%.||||||0.0002|||||||Farrington-Manning test of two ind. prop|||||||0.0002
91491861|NCT00980057|182856642|SUPERIORITY|The pre-specified minimum objective performance criteria was 0.82|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91698602|NCT00986921|183292009|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0||||A threshold value of p of 0.05 was considered significant.|Chi-squared|||The null hypothesis was that the groups would vary, with a p values of less than 0.05.||||0.49
91698603|NCT00986921|183292010|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
91698604|NCT04445714|183292017|SUPERIORITY||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.34|-1.03|||Paired t-test test|||Change from baseline||-1.03|-1.34|<.0001
91698605|NCT04445714|183292018|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.51|||Paired t-test test|||Change from baseline||-1.51|-2.66|<.0001
91730342|NCT04003142|183355923|SUPERIORITY|Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)|Least squares (LS) Mean difference|-1.82|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.73|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.91|-2.73|<0.001
91730343|NCT04003142|183355923|SUPERIORITY||LSMean difference|-2.55|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.45|-1.64||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.64|-3.45|<0.001
91730344|NCT04003142|183355923|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
91730345|NCT04003142|183355923|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
91730346|NCT04003142|183355924|SUPERIORITY||LSMean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.55|<|0.001||95.0|-2.94|-0.78||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.78|-2.94|<0.001
91730347|NCT04003142|183355924|SUPERIORITY||LSMean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.6|-1.46||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.46|-3.60|<0.001
91730348|NCT04003142|183355924|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
91491862|NCT00980057|182856644|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91491863|NCT00980057|182856645|NON_INFERIORITY|The non-inferiority margin is 15|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91491864|NCT00980057|182856646|NON_INFERIORITY|The non-inferiority margin is 2.5||||||0.0009|||||||t-test, 1 sided|||||||0.0009
91491865|NCT00980057|182856647|NON_INFERIORITY|The non-inferiority margin is 0.3|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91698606|NCT04445714|183292019|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.8416|TWO_SIDED|95.0|-2.34|1.91|||Paired t-test test|||Change from baseline||1.91|-2.34|0.8416
91698607|NCT04445714|183292020|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.0001|TWO_SIDED|95.0|-33.4|-15.4|||Paired t-test test|||Change from baseline||-15.4|-33.4|<.0001
91698608|NCT02396420|183292028|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698609|NCT02396420|183292029|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698610|NCT02396420|183292030|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698611|NCT02396420|183292031|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
91730349|NCT04003142|183355924|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
91730350|NCT04003142|183355925|SUPERIORITY||LSMean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.021||95.0|-0.27|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.02|-0.27|0.021
91730351|NCT04003142|183355925|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001||95.0|-0.41|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.16|-0.41|<0.001
91730352|NCT04003142|183355925|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
91730353|NCT04003142|183355925|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
91730354|NCT04003142|183355926|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.049||95.0|-0.33|0.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.00|-0.33|0.049
91730355|NCT04003142|183355926|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.45|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.13|-0.45|<0.001
91730356|NCT04003142|183355926|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
91698612|NCT02396420|183292032|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
91698613|NCT02396420|183292033|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698614|NCT02396420|183292034|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698615|NCT02396420|183292035|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91491866|NCT00980057|182856648|NON_INFERIORITY|The non-inferiority margin is 30||||||0.0002|||||||t-test, 1 sided|||||||0.0002
91491867|NCT00980057|182856649|NON_INFERIORITY|The non-inferiority margin is 5.1||||||0.002|||||||t-test, 1 sided|||||||0.002
91698616|NCT02396420|183292036|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698617|NCT02396420|183292037|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698618|NCT02396420|183292038|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698619|NCT02396420|183292039|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91730357|NCT04003142|183355926|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
91730358|NCT04003142|183355927|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.381|TWO_SIDED|95.0|-2.1|0.8||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.8|-2.1|0.381
91730359|NCT04003142|183355927|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.007|TWO_SIDED|95.0|-3.5|-0.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.6|-3.5|0.007
91730360|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.09|-0.51||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.51|-2.09|0.001
91491868|NCT01397084|182856661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
91491869|NCT02139228|182856665|SUPERIORITY_OR_OTHER||Vaccine Group Ratios|0.53|||||TWO_SIDED|95.0|0.36|0.76|||ANOVA|||||0.76|0.36|
91491870|NCT02139228|182856666|SUPERIORITY_OR_OTHER||Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-18.6|-4.2|||Clopper-Pearson|||||-4.2|-18.6|
91491871|NCT00706823|182856674|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
91698620|NCT02396420|183292040|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698621|NCT02396420|183292041|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698622|NCT02396420|183292042|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698623|NCT02396420|183292043|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698624|NCT02396420|183292044|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
91698625|NCT01273623|183292048|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91730361|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.4|<|0.001||95.0|-2.51|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.91|-2.51|<0.001
91730362|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.65|-0.87||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.87|-2.65|<0.001
91730363|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.86|-1.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.08|-2.86|<0.001
91730364|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-2.63|-0.84||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.84|-2.63|<0.001
91759153|NCT04038567|183411361|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-1.12|1.23||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.23|-1.12|
91698626|NCT01640379|183292051|SUPERIORITY||Odds Ratio (OR)|0.4||||0.07|TWO_SIDED|95.0|0.15|1.09||Judged by type one error limit alpha = 0.05.|t-test, 2 sided||The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.|A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.||1.09|0.15|0.070
91698627|NCT01640379|183292051|SUPERIORITY||Odds Ratio (OR)|0.59||||0.043|TWO_SIDED|95.0|0.39|0.98||Judged by type one error limit alpha = 0.05.|generalized estimating equations||The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.|"We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.~The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm."||0.98|0.39|0.043
91698628|NCT01640379|183292052|SUPERIORITY||Odds Ratio (OR)|92.2|||<|0.001|TWO_SIDED|95.0|37.0|230.1|||Chi-squared|Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.|Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.|H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.||230.1|37.0|<0.001
91698629|NCT01640379|183292052|SUPERIORITY||Odds Ratio (OR)|0.6||||0.084|TWO_SIDED|95.0|0.36|1.05|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for intervention arm relative to control.|H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.||1.05|0.36|0.084
91730365|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.29|-1.5||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.50|-3.29|<0.001
91730366|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.48|<|0.001||95.0|-2.79|-0.9||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.90|-2.79|<0.001
91491872|NCT00706823|182856675|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
91491873|NCT00706823|182856677|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
91491874|NCT00706823|182856679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.11||||0.03|TWO_SIDED|95.0|1.1|58.6|||Regression, Logistic|||||58.6|1.1|0.03
91730367|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.61|-1.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.72|-3.61|<0.001
91730368|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.78|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.71|-0.85||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.85|-2.71|<0.001
91730369|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.47|<|0.001||95.0|-3.59|-1.73||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.73|-3.59|<0.001
91491875|NCT03766581|182856680|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.87|1.1|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg QD over Placebo||1.10|0.87|
91491876|NCT03766581|182856680|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.83|1.15|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg BID over Placebo||1.15|0.83|
91730370|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-2.77|-0.83||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.83|-2.77|<0.001
91491877|NCT03766581|182856680|SUPERIORITY||Relative Risk (RR)|0.93|||||TWO_SIDED|95.0|0.76|1.16|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 50 mg BID over Placebo||1.16|0.76|
91491878|NCT03766581|182856680|SUPERIORITY||Relative Risk (RR)|0.92|||||TWO_SIDED|95.0|0.73|1.18|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 100 mg BID over Placebo||1.18|0.73|
91491879|NCT03766581|182856680|SUPERIORITY||Relative Risk (RR)|0.91|||||TWO_SIDED|95.0|0.69|1.31|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 200 mg BID over Placebo||1.31|0.69|
91491880|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.49|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg QD over Placebo||1.49|0.46|
91698630|NCT01640379|183292052|SUPERIORITY||Odds Ratio (OR)|0.9||||0.867|TWO_SIDED|95.0|0.36|2.34|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.|H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.||2.34|0.36|0.867
91698631|NCT01640379|183292052|SUPERIORITY||Odds Ratio (OR)|0.6||||0.153|TWO_SIDED|95.0|0.33|1.19|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.|H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.||1.19|0.33|0.153
91698632|NCT01640379|183292052|SUPERIORITY||Odds Ratio (OR)|1.0||||0.351|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for women in the TECH-N arm relative to women in the control arm.|H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.||1.06|0.86|0.351
91698633|NCT04223635|183292053|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Interval (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|92.6|||||TWO_SIDED|90.0|54.38|157.69|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||157.69|54.38|
91698634|NCT04223635|183292055|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|147.17|||||TWO_SIDED|90.0|95.39|227.07|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||227.07|95.39|
91698635|NCT04223635|183292056|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|142.87|||||TWO_SIDED|90.0|91.21|223.79|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||223.79|91.21|
91698636|NCT02122887|183292083|OTHER|χ² (1) =4.57, Cramer's V=.24|||||<|0.05|||||||Chi-squared|||we hypothesised that following intervention, those undergoing intervention will be more likely to see justice on both sides, compared to control group||||<0.05
91491881|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg BID over Placebo||1.30|0.36|
91491882|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|0.72|||||TWO_SIDED|95.0|0.39|1.33|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg BID over Placebo||1.33|0.39|
91491883|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|0.65|||||TWO_SIDED|95.0|0.33|1.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg BID over Placebo||1.25|0.33|
91698637|NCT02122887|183292084|EQUIVALENCE|we compared participants levels of tension (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.65|||>|0.05|TWO_SIDED|95.0|||||ANOVA|df=1||||||>0.05
91698638|NCT02122887|183292085|EQUIVALENCE|we compared participants levels of empathy (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.04|||>|0.05|TWO_SIDED|95.0|||||ANOVA|||||||>0.05
91698639|NCT03320850|183292086|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.635||0.0845|TWO_SIDED|95.0|-0.15|2.35|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.35|-0.15|0.0845
91491884|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|1.4|||||TWO_SIDED|95.0|0.87|2.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 200 mg BID||2.25|0.87|
91698640|NCT03320850|183292086|SUPERIORITY||Least Squares Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|0.633||0.0041|TWO_SIDED|95.0|0.59|3.08|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||3.08|0.59|0.0041
91491885|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|2.48|||||TWO_SIDED|95.0|0.83|7.42|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg QD over Placebo||7.42|0.83|
91491886|NCT03766581|182856702|SUPERIORITY||Relative Risk (RR)|1.01|||||TWO_SIDED|95.0|0.15|6.96|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg QD over Placebo||6.96|0.15|
91491887|NCT03716024|182856703|SUPERIORITY||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|1.3|26.0|||||omadacycline minus linezolid|||26.0|1.3|
91491888|NCT03716024|182856704|SUPERIORITY||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-1.7|11.4|||||omadacycline minus linezolid|||11.4|-1.7|
91491889|NCT03716024|182856705|SUPERIORITY||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|0.9|26.7|||||omadacycline minus linezolid|||26.7|0.9|
91491890|NCT03716024|182856706|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-5.3|14.0||||||||14.0|-5.3|
91491891|NCT01056653|182856713|SUPERIORITY_OR_OTHER||||||=|0.03|||||||ANCOVA|F(2,107)=3.48, partial n2=0.061, observed power=0.639||ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||=0.03
91698641|NCT03320850|183292086|SUPERIORITY||Least Squares Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.632||0.06|TWO_SIDED|95.0|-0.05|2.44|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.44|-0.05|0.0600
91698642|NCT03320850|183292086|SUPERIORITY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|0.631||0.1702|TWO_SIDED|95.0|-0.37|2.11|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.11|-0.37|0.1702
91698643|NCT03320850|183292088|SUPERIORITY||Least Square Mean|0.73|STANDARD_ERROR_OF_MEAN|0.617||0.2361|TWO_SIDED|95.0|-0.48|1.95|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.95|-0.48|0.2361
91698644|NCT03320850|183292088|SUPERIORITY||Least Square Mean|0.78|STANDARD_ERROR_OF_MEAN|0.608||0.1985|TWO_SIDED|95.0|-0.41|1.98|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.98|-0.41|0.1985
91698645|NCT03320850|183292088|SUPERIORITY||Least Square Mean|0.64|STANDARD_ERROR_OF_MEAN|0.607||0.2923|TWO_SIDED|95.0|-0.56|1.84|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.84|-0.56|0.2923
91698646|NCT03320850|183292088|SUPERIORITY||Least Square Mean|0.54|STANDARD_ERROR_OF_MEAN|0.609||0.3769|TWO_SIDED|95.0|-0.66|1.74|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.74|-0.66|0.3769
91698647|NCT03320850|183292089|SUPERIORITY||Least Square Mean|-7.05|STANDARD_ERROR_OF_MEAN|13.107||0.5911|TWO_SIDED|95.0|-32.87|18.77|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||18.77|-32.87|0.5911
91698648|NCT03320850|183292089|SUPERIORITY||Least Square Mean|-8.0|STANDARD_ERROR_OF_MEAN|12.956||0.5375|TWO_SIDED|95.0|-33.52|17.52|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||17.52|-33.52|0.5375
91698649|NCT03320850|183292089|SUPERIORITY||Least Square Mean|-1.33|STANDARD_ERROR_OF_MEAN|12.764||0.9173|TWO_SIDED|95.0|-26.47|23.81|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||23.81|-26.47|0.9173
91698650|NCT03320850|183292089|SUPERIORITY||Least Square Mean|9.33|STANDARD_ERROR_OF_MEAN|12.981||0.473|TWO_SIDED|95.0|-16.24|34.9|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||34.90|-16.24|0.4730
91698651|NCT02002533|183292097|SUPERIORITY||||||>|0.9999|||||||exact binomial test|The percentage is greater than or equal to 40%.||||||>0.9999
91698652|NCT02002533|183292098|SUPERIORITY|||||||0.735|||||||exact binomial test|||||||0.7350
91698653|NCT02002533|183292099|SUPERIORITY||Mean Difference (Final Values)|0.8075|STANDARD_ERROR_OF_MEAN|0.0845|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91698654|NCT02002533|183292100|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.21||0.1808|TWO_SIDED||||||ANCOVA||The estimated value is BBT minus HEAL.|||||0.1808
91698655|NCT02002533|183292101|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.73||0.14|TWO_SIDED||||||ANCOVA||Estimated value is BBT minus HEAL.|||||0.14
91698656|NCT02002533|183292102|SUPERIORITY||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.137||0.005|TWO_SIDED||||||ANCOVA|For baseline of 0.7.||||||0.005
91698657|NCT02002533|183292102|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|||||At baseline 1.3.|ANCOVA|||||||0.092
91698658|NCT02002533|183292102|SUPERIORITY||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.053||0.556|TWO_SIDED|||||At baseline of 1.5.|ANCOVA|||||||0.556
91698659|NCT02002533|183292102|SUPERIORITY||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|||||Grouped by baseline interaction.|ANCOVA||The estimated value is grouped by baseline interaction parameter.|||||0.007
91698660|NCT02002533|183292103|SUPERIORITY|||||||0|||||||ANCOVA|||||||0.000
91698661|NCT02002533|183292104|SUPERIORITY|||||||0.295|||||||ANCOVA|||||||0.295
91698662|NCT02002533|183292105|SUPERIORITY|||||||0.573|||||||ANCOVA|||||||0.573
91698663|NCT02002533|183292106|SUPERIORITY||Mean Difference (Final Values)|-6.502|STANDARD_ERROR_OF_MEAN|2.558||0.015|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.015
91698664|NCT02002533|183292106|SUPERIORITY||Mean Difference (Final Values)|-1.723|STANDARD_ERROR_OF_MEAN|1.007||0.094|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.094
91698665|NCT02002533|183292106|SUPERIORITY||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.326||0.114|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.114
91730371|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-3.3|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.37|-3.30|<0.001
91730372|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.79|-0.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.74|-2.79|<0.001
91491892|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.03||||||Bonferroni adjustments for multiple comparisons used|ANOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.03
91730373|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.38|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-3.4|-1.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.35|-3.40|<0.001
91730374|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.65|STANDARD_ERROR_OF_MEAN|0.54||0.002||95.0|-2.71|-0.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.59|-2.71|0.002
91730375|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.51|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-3.57|-1.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.45|-3.57|<0.001
91491893|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.534||||||Bonferroni adjustment for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.534
91491894|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANCOVA|F(2,107)=3.145, partial n2=0.056, observed power=0.593.||ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.047
91491895|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.056||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.056
91698666|NCT02002533|183292106|SUPERIORITY||Mean Difference (Final Values)|0.911|STANDARD_ERROR_OF_MEAN|0.4||0.027|TWO_SIDED||||||ANCOVA||This is an arm by baseline interaction parameter.|||||0.027
91698667|NCT03796442|183292110|NON_INFERIORITY|The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis.||||||0.0004|||||||t-test, 1 sided|||The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025.||||0.0004
91698668|NCT02031640|183292138|SUPERIORITY||Least Square Mean (LSM) Difference|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||ANCOVA|||||0.095|-0.027|0.272
91698669|NCT02031640|183292138|SUPERIORITY||LSM Difference|0.045||||0.1415|TWO_SIDED|95.0|-0.015|0.106|||ANCOVA|||||0.106|-0.015|0.1415
91698670|NCT02031640|183292138|SUPERIORITY||LSM Difference|-0.015||||0.6356|TWO_SIDED|95.0|-0.075|0.046|||ANCOVA|||||0.046|-0.075|0.6356
91730376|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-2.96|-0.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.86|-2.96|<0.001
91730377|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-3.69|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.60|-3.69|<0.001
91730378|NCT04003142|183355928|SUPERIORITY||LSMean difference|-1.86|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-2.91|-0.81||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.81|-2.91|<0.001
91730379|NCT04003142|183355928|SUPERIORITY||LSMean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.61|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.52|-3.61|<0.001
91730380|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.001||95.0|-0.21|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.05|-0.21|0.001
91491896|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.267||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.267
91491897|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|F(2,107)=3.440, partial n2=0.060, observed power=0.634||ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.036
91491898|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.036||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||0.036
91528450|NCT04711460|182932219|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.09||0.054|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.054
91698671|NCT02031640|183292138|SUPERIORITY||LSM Difference|0.04||||0.1932|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.1|-0.02|0.1932
91698672|NCT02031640|183292139|OTHER|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction.|LSM Difference|10.616||||0.0036|TWO_SIDED|95.0|3.489|17.744|||Mixed Model for repeated measures|||||17.744|3.489|0.0036
91698673|NCT02031640|183292139|SUPERIORITY||LSM Difference|8.419||||0.0204|TWO_SIDED|95.0|1.309|15.53|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||15.53|1.309|0.0204
91698674|NCT02031640|183292139|SUPERIORITY||LSM Difference|6.004||||0.0984|TWO_SIDED|95.0|-1.121|13.129|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||13.129|-1.121|0.0984
91698675|NCT02031640|183292139|SUPERIORITY||LSM Difference|12.512||||0.0006|TWO_SIDED|95.0|5.435|19.589|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||19.589|5.435|0.0006
91698676|NCT02031640|183292140|SUPERIORITY||LSM Difference|9.147||||0.0139|TWO_SIDED|95.0|1.866|16.429|||Mixed Model for repeated measures|||||16.429|1.866|0.0139
91698677|NCT02031640|183292140|SUPERIORITY||LSM Difference|9.17||||0.0133|TWO_SIDED|95.0|1.914|16.425|||Mixed Model for repeated measures|||||16.425|1.914|0.0133
91698678|NCT02031640|183292140|SUPERIORITY||LSM Difference|4.088||||0.2704|TWO_SIDED|95.0|-3.191|11.367|||Mixed Model for repeated measures|||||11.367|-3.191|0.2704
91698679|NCT02031640|183292140|SUPERIORITY||LSM Difference|10.301||||0.0053|TWO_SIDED|95.0|3.073|17.53|||Mixed Model for repeated measures|||||17.53|3.073|0.0053
91698680|NCT02031640|183292141|SUPERIORITY||LSM Difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.044|-0.363|||Mixed Model for repeated measures|||||-0.363|-1.044|<0.0001
91698681|NCT02031640|183292141|SUPERIORITY||LSM Difference|-0.691|||<|0.0001|TWO_SIDED|95.0|-1.029|-0.352|||Mixed Model for repeated measures|||||-0.352|-1.029|<0.0001
91491899|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||1||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||1.00
91491900|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|F(2,107)=0.409||ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.665
91698682|NCT02031640|183292141|SUPERIORITY||LSM Difference|-0.651||||0.0002|TWO_SIDED|95.0|-0.994|-0.309|||Mixed Model for repeated measures|||||-0.309|-0.994|0.0002
91698683|NCT02031640|183292141|SUPERIORITY||LSM difference|-0.801|||<|0.0001|TWO_SIDED|95.0|-1.138|-0.464|||Mixed Model for repeated measures|||||-0.464|-1.138|<0.0001
91698684|NCT02031640|183292142|SUPERIORITY||Mean Difference (Final Values)|-0.149||||0.0119|TWO_SIDED|95.0|-0.265|-0.033|||Mixed Models Analysis|||||-0.033|-0.265|0.0119
91698685|NCT02031640|183292142|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.0854|TWO_SIDED|95.0|-0.217|0.014|||Mixed Models Analysis|||||0.014|-0.217|0.0854
91698686|NCT02031640|183292142|SUPERIORITY||Mean Difference (Final Values)|-0.189||||0.0016|TWO_SIDED|95.0|-0.306|-0.072|||Mixed Models Analysis|||||-0.072|-0.306|0.0016
91698687|NCT02031640|183292142|SUPERIORITY||Mean Difference (Final Values)|-0.216||||0.0003|TWO_SIDED|95.0|-0.332|-0.101|||Mixed Models Analysis|||||-0.101|-0.332|0.0003
91698688|NCT01895270|183292169|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||.42
91698689|NCT02091375|183292175|SUPERIORITY||Median Difference (Final Values)|-22.79||||0.0123|TWO_SIDED|95.0|-41.06|-5.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach.|||-5.43|-41.06|0.0123
91698690|NCT02091375|183292176|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0784|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|Stratified by age group (2-5 years, 6-12 years, and 13-18 years).||||4.30|0.93|0.0784
91698691|NCT00537316|183292200|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Chi-squared|||||||0.032
91698692|NCT00782184|183292215|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||<|0.001|TWO_SIDED|95.0|3.4|21.0|||Regression, Logistic|||COMPARISON BETWEEN GROUPS FOR NUMBER OF PARTICIPANTS REACHING LDL-C GOAL OF \<70 MG/DL||21.0|3.4|<0.001
91698693|NCT00782184|183292216|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-15.0|||<|0.001|TWO_SIDED|95.0|-21.15|-8.84|||Longitudinal Data Analysis (LDA) Model|||||-8.84|-21.15|<0.001
91698694|NCT00782184|183292217|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|3.3|13.9|||Regression, Logistic|||||13.9|3.3|<0.001
91698695|NCT00782184|183292218|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|6.0|||Regression, Logistic|||||6.0|2.0|<0.001
91698696|NCT00782184|183292219|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.24|||<|0.001|TWO_SIDED|95.0|-12.5|-3.97|||LDA Model|||||-3.97|-12.50|<0.001
91698697|NCT00782184|183292220|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.13||||0.593|TWO_SIDED|95.0|-5.67|9.93|||LDA Model|||||9.93|-5.67|0.593
91491901|NCT01056653|182856713|SUPERIORITY_OR_OTHER|||||||0.732|||||||ANCOVA|F(2,107)=0.313||ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.732
91491902|NCT01056653|182856714|SUPERIORITY_OR_OTHER|||||||0.61|||||||ANCOVA|F(2,107)=0.49||ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.61
91491903|NCT01056653|182856714|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|F(2,107)=0.96||ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.38
91528451|NCT04711460|182932219|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.93||0.019|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.019
91698698|NCT00782184|183292221|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.48||||0.211|TWO_SIDED|95.0|-1.41|6.37|||LDA Model|||||6.37|-1.41|0.211
91698699|NCT00782184|183292222|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.62|||<|0.001|TWO_SIDED|95.0|-17.32|-5.92|||LDA Model|||||-5.92|-17.32|<0.001
91698700|NCT00782184|183292223|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-16.1|||<|0.001|TWO_SIDED|95.0|-22.77|-9.44|||LDA Model|||||-9.44|-22.77|<0.001
91698701|NCT00782184|183292224|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.02|||<|0.001|TWO_SIDED|95.0|-14.96|-5.08|||LDA Model|||||-5.08|-14.96|<0.001
91698702|NCT00782184|183292225|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.21|||<|0.001|TWO_SIDED|95.0|-19.83|-6.59|||LDA Model|||||-6.59|-19.83|<0.001
91698703|NCT00782184|183292226|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-7.69||||0.002|TWO_SIDED|95.0|-12.5|-2.88|||LDA Model|||||-2.88|-12.50|0.002
91491904|NCT01056653|182856715|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|F(2,106)=2.24.||ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.11
91491905|NCT01056653|182856715|SUPERIORITY_OR_OTHER|||||||0.686|||||||ANCOVA|F(2,106)=0.379||ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.686
91491906|NCT01056653|182856715|SUPERIORITY_OR_OTHER|||||||0.121|||||||ANCOVA|F(2,106)=2.158||ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.121
91698704|NCT00782184|183292227|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|5.25|||<|0.001|TWO_SIDED|95.0|2.44|8.06|||LDA Model|||||8.06|2.44|<0.001
91698705|NCT00782184|183292228|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.91|||<|0.001|TWO_SIDED|95.0|-18.31|-7.52|||LDA Model|||||-7.52|-18.31|<0.001
91698706|NCT00782184|183292229|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.68||||0.785|TWO_SIDED|95.0|-16.5|21.86|||LDA Model|||||21.86|-16.50|0.785
91698707|NCT01730534|183292246|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.172||95.0|0.84|1.03|||Regression, Cox|||||1.03|0.84|0.172
91698708|NCT01730534|183292247|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.005||95.0|0.73|0.95|||Regression, Cox|||||0.95|0.73|0.005
91698709|NCT01730534|183292248|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.001||95.0|0.67|0.87|||Regression, Cox|||||0.87|0.67|<0.001
91698710|NCT01730534|183292249|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.198||95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.198
91698711|NCT01369108|183292285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||null hypothesis no difference in anatomic form||||0.8
91698712|NCT01369108|183292285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||null hypothesis no difference in margin adaptation||||0.89
91698713|NCT01369108|183292285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||null hypothesis no difference in margin discoloration||||0.79
91698714|NCT01369108|183292285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||ANOVA|||null hypothesis no difference in surface integrity||||0.18
91698715|NCT01369108|183292285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||null hypothesis no difference in secondary caries||||0.66
91698716|NCT01369108|183292286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||ANOVA|||null hypothesis no difference in sensitivity to cold||||0.522
91698717|NCT01369108|183292286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.449|||||||Chi-squared|||null hypothesis no difference in biting pressure||||.449
91698718|NCT01895608|183292287|OTHER|non-parametric statistic: Mann-Whitney U test for independent samples||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.562
91698719|NCT01895608|183292287|OTHER|||||||0.414|||||||Wilcoxon (Mann-Whitney)|non-parametric statistical analysis: Mann Whitney U Test for independent samples||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.414
91698720|NCT01895608|183292288|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.181
91491907|NCT05275400|182856716|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Difference|-0.089|||||TWO_SIDED|95.0|-0.191|0.013||||||||0.013|-0.191|
91491908|NCT05275400|182856717|SUPERIORITY||LS Mean Difference|-0.089||||0.088|TWO_SIDED|95.0|-0.191|0.013|||ANCOVA|||||0.013|-0.191|0.088
91491909|NCT05275400|182856718|SUPERIORITY||Relative rate|1.03||||0.897|TWO_SIDED|95.0|0.62|1.74|||Negative binomial model|||||1.74|0.62|0.897
91491910|NCT05275400|182856719|SUPERIORITY||LS Mean Difference|0.42||||0.722|TWO_SIDED|95.0|-1.88|2.72|||ANCOVA|||||2.72|-1.88|0.722
91491911|NCT05275400|182856720|SUPERIORITY||LS Mean Difference|-0.84||||0.605|TWO_SIDED|95.0|-4.01|2.33|||ANCOVA|||||2.33|-4.01|0.605
91491912|NCT05275400|182856721|SUPERIORITY||LS Mean Difference|-30.0||||0.003|TWO_SIDED|95.0|-50.1|-9.97|||Mixed Models Analysis|||||-9.97|-50.10|0.003
91491913|NCT05275400|182856722|SUPERIORITY||Relative rate|1.14||||0.43|TWO_SIDED|95.0|0.83|1.56|||Negative binomial model|||||1.56|0.83|0.430
91491914|NCT05275400|182856723|SUPERIORITY||LS Mean Difference|0.071||||0.756|TWO_SIDED|95.0|-0.38|0.52|||Mixed Models Analysis|||||0.52|-0.38|0.756
91491915|NCT05275400|182856724|SUPERIORITY||LS Mean Difference|0.14||||0.021|TWO_SIDED|95.0|0.02|0.27|||ANCOVA|||||0.27|0.02|0.021
91491916|NCT05275400|182856725|SUPERIORITY||LS Mean Difference|-0.99||||0.417|TWO_SIDED|95.0|-3.37|1.4|||ANCOVA|||||1.40|-3.37|0.417
91698721|NCT01895608|183292288|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||1.000
91698722|NCT01895608|183292289|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||1.000
91698723|NCT01895608|183292289|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.662|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.662
91491917|NCT05275400|182856726|SUPERIORITY||LS Mean Difference|3.15|||<|0.001|TWO_SIDED|95.0|1.71|4.59|||Mixed Models Analysis|||Week 26||4.59|1.71|<0.001
91491918|NCT05275400|182856726|SUPERIORITY||LS Mean Difference|3.56|||<|0.001|TWO_SIDED|95.0|2.05|5.07|||Mixed Models Analysis|||Week 52||5.07|2.05|<0.001
91491919|NCT05275400|182856726|SUPERIORITY||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|1.75|4.94|||Mixed Models Analysis|||Week 78||4.94|1.75|<0.001
91491920|NCT03727230|182856739|OTHER||||||<|0.001|||||||Chi-squared|||In this study, a single-arm clinical trial was conducted. The summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis (Ji YL, et al. Vox Sang 2022; 117: 633-40) was used as the control for comparison with alloanti-D rate identified in Asian-type DEL patients after RhD+ RBC transfusion in the clinical trial.||||< 0.001
91491921|NCT03600818|182856741|SUPERIORITY||Difference in percentage|18.0|||=|0.0193|TWO_SIDED|95.0|4.15|31.82||Threshold for significance at 0.05 level.|Fisher Exact|||||31.82|4.15|=0.0193
91491922|NCT03600818|182856742|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Wilcoxon rank-sum test|||A hierarchical testing procedure was used to control the overall type I error. If the primary endpoint reaches statistical significance then the secondary endpoint for total cumulative CS dose was tested next.||||<0.0001
91491923|NCT04377620|182856774|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0292|TWO_SIDED|95.0|0.201|1.028|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.028|0.201|0.0292
91491924|NCT04377620|182856774|SUPERIORITY||Odds Ratio (OR)|0.42||||0.028|TWO_SIDED|95.0|0.171|1.023|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.023|0.171|0.0280
91491925|NCT00044083|182856814|OTHER||||||<|0.0001||||||Diagnosis effect on placebo|ANOVA|||||||<0.0001
91491926|NCT00044083|182856814|OTHER|||||||0.0034||||||Drug Effect on Patients|ANOVA|||||||0.0034
91491927|NCT00044083|182856815|OTHER||||||<|0.0001||||||Diagnosis Effect on Placebo in right DLPFC|ANOVA|||||||<0.0001
91491928|NCT00044083|182856815|OTHER|||||||0.014||||||Diagnosis Effect of Placebo in left DLPFC|ANOVA|||||||0.014
91491929|NCT00044083|182856816|OTHER|||||||0.05||||||Drug Effect across both groups in left DLPFC|ANOVA|||||||0.05
91491930|NCT00044083|182856816|OTHER|||||||0.32||||||Drug Effect across both groups in right DLPFC|ANOVA|||||||0.32
91491931|NCT00044083|182856817|OTHER|||||||0.05||||||The Effect of Drug on Patients with Schizophrenia in right DLPFC|t-test, 1 sided|||||||0.05
91491932|NCT00044083|182856817|OTHER|||||||0.078||||||Effect of Drug on Patients with Schizophrenia in left DLPFC|t-test, 1 sided|||||||0.078
91491933|NCT00044083|182856818|OTHER|||||||0.05||||||Drug Effect on Healthy Volunteers in left DLPFC|t-test, 1 sided|||||||0.05
91491934|NCT00044083|182856818|OTHER|||||||0.73||||||Drug Effect on Healthy Volunteers in right DLPFC|t-test, 1 sided|||||||0.73
91491935|NCT00044083|182856819|OTHER||||||<|0.0001|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in right DLPFC||||||<0.0001
91698724|NCT01895608|183292290|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.05
91491936|NCT00044083|182856819|OTHER|||||||0.167|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in left DLPFC||||||0.167
91491937|NCT00044083|182856820|OTHER|||||||0.189||||||Drug by Genotype Effect in left DLPFC|ANOVA|||||||0.189
91491938|NCT00044083|182856820|OTHER|||||||0.041||||||Drug Effect on Val/Val Genotype in left DLPFC|t-test, 1 sided|||||||0.041
91491939|NCT00044083|182856820|OTHER|||||||0.718||||||Drug Effect on Val/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.718
91491940|NCT00044083|182856820|OTHER|||||||0.469||||||Drug Effect of Met/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.469
91491941|NCT00044083|182856821|OTHER|||||||0.7||||||Drug Effect on Positive Syndrome for Patients|t-test, 1 sided|||||||0.7
91491942|NCT00044083|182856821|OTHER|||||||0.4||||||Drug Effect on Negative Syndrome for Patients|t-test, 1 sided|||||||0.4
91698725|NCT01895608|183292290|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.171|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.171
91491943|NCT00044083|182856821|OTHER|||||||0.12||||||Drug Effect on General Pathology for Patients|t-test, 1 sided|||||||0.12
91491944|NCT03758066|182856838|OTHER|||||||0.03||||||P-value reported for quality of life measured between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.03
91491945|NCT03758066|182856839|SUPERIORITY|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.02
91491946|NCT03758066|182856839|OTHER|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between 6- and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||||||.02
91698726|NCT01895608|183292291|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.313|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.313
91491947|NCT00332163|182856841|SUPERIORITY_OR_OTHER||Difference|-33.0|||||TWO_SIDED|95.0|-51.0|-14.0|||||Difference = Pre-emptive - Reactive|||-14|-51|
91491948|NCT00332163|182856842|SUPERIORITY_OR_OTHER||Difference|-22.0|||||TWO_SIDED|95.0|-42.0|-3.0|||||Difference = Pre-emptive - Reactive|||-3|-42|
91491949|NCT00332163|182856843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (pre-emptive vs. reactive), stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
91491950|NCT00332163|182856845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
91491951|NCT00332163|182856846|SUPERIORITY_OR_OTHER||Difference|-4.0|||||TWO_SIDED|95.0|-16.0|7.0|||||Difference = Pre-emptive - Reactive|||7|-16|
91491952|NCT00332163|182856847|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.0|10.0|||||Difference = Pre-emptive - Reactive|||10|-10|
91491953|NCT00332163|182856848|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|95.0|-9.0|17.0|||||Rate difference = Pre-emptive - Reactive|||17|-9|
91491954|NCT00332163|182856849|SUPERIORITY_OR_OTHER||Difference|-1.0|||||TWO_SIDED|95.0|-21.0|18.0|||||Rate difference = Pre-emptive - Reactive|||18|-21|
91491955|NCT00332163|182856850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.0|0.9|
91491956|NCT00332163|182856851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.5|0.6|
91491957|NCT00332163|182856852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.1|0.7|
91491958|NCT00332163|182856853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.6|||||Hazard ratio is estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.6|0.6|
91491959|NCT03706079|182856878|SUPERIORITY||Rate Ratio|0.42|||||TWO_SIDED|95.0|0.35|0.51||||||||0.51|0.35|
91491960|NCT03706079|182856878|SUPERIORITY||Rate Ratio|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||||0.96|0.38|
91513258|NCT02710630|182898019|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|71.4|STANDARD_DEVIATION|49.2|||TWO_SIDED|90.0|58.828|86.648|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||86.648|58.828|
91698727|NCT01895608|183292291|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.852|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.852
91698728|NCT01895608|183292292|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.263|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.263
91698729|NCT01895608|183292292|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.181
91698730|NCT02833844|183292320|SUPERIORITY||treatment difference|-56.92|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-61.55|-52.28||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-52.28|-61.55|< 0.0001
91698731|NCT02833844|183292321|SUPERIORITY||treatment difference|-75.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-82.1|-68.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-68.4|-82.1|< 0.0001
91730381|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.24|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.08|-0.24|<0.001
91730382|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001||95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
91730383|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
91730384|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.067||95.0|-0.23|0.01||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||0.01|-0.23|0.067
91730385|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.35|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.11|-0.35|<0.001
91730386|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED|95.0|-0.3|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.03|-0.30|0.020
91698732|NCT02833844|183292322|SUPERIORITY||treatment difference|65.4|||<|0.0001|TWO_SIDED|95.0|57.8|71.1||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||71.1|57.8|< 0.0001
91730387|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.16|-0.43|<0.001
91730388|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.012|TWO_SIDED|95.0|-0.32|-0.04||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.04|-0.32|0.012
91730389|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.42|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.14|-0.42|<0.001
91730390|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.31|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.02|-0.31|0.030
91730391|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.14|-0.43|<0.001
91698733|NCT02833844|183292323|SUPERIORITY||treatment difference|71.9|||<|0.0001|TWO_SIDED|95.0|65.7|76.7||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as a reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||76.7|65.7|< 0.0001
91730392|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.095|TWO_SIDED|95.0|-0.28|0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||0.02|-0.28|0.095
91730393|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.41|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.41|<0.001
91730394|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.109|TWO_SIDED|95.0|-0.28|0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||0.03|-0.28|0.109
91698734|NCT02833844|183292324|SUPERIORITY||treatment difference|-50.94|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-54.88|-46.99||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-46.99|-54.88|< 0.0001
91730395|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.43|<0.001
91513259|NCT02710630|182898019|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|116.67|STANDARD_DEVIATION|37.7|||TWO_SIDED|90.0|100.516|135.41|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.410|100.516|
91698735|NCT02833844|183292325|SUPERIORITY||treatment difference|-47.73|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED|95.0|-51.11|-44.35||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-44.35|-51.11|< 0.0001
91698736|NCT02833844|183292326|SUPERIORITY||treatment difference|-38.12|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|-41.3|-34.94||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-34.94|-41.30|< 0.0001
91698737|NCT02833844|183292327|SUPERIORITY||treatment difference|-26.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-34.17|-19.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-19.40|-34.17|< 0.0001
91698738|NCT02833844|183292328|SUPERIORITY||treatment difference|-22.46|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-31.03|-13.88||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-13.88|-31.03|< 0.0001
91730396|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02||95.0|-0.35|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.03|-0.35|0.020
91730397|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.15|-0.47|<0.001
91730398|NCT04003142|183355929|SUPERIORITY||LSMean diferrence|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012||95.0|-0.37|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.05|-0.37|0.012
91730399|NCT04003142|183355929|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.15|-0.47|<0.001
91698739|NCT02833844|183292329|SUPERIORITY||treatment difference|8.36|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|4.83|11.89||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||11.89|4.83|< 0.0001
91698740|NCT02833844|183292330|SUPERIORITY||treatment difference|-22.15|STANDARD_ERROR_OF_MEAN|4.01|<|0.0001|TWO_SIDED|95.0|-30.04|-14.26||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-14.26|-30.04|< 0.0001
91698741|NCT01646021|183292336|OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.35|0.6|||Log Rank|||||0.60|0.35|< 0.0001
91698742|NCT01646021|183292338|SUPERIORITY||Hazard Ratio (HR)|0.74|||=|0.0621|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|= 0.0621
91698743|NCT02347891|183292353|SUPERIORITY||Risk Ratio (RR)|0.5||||0.6|TWO_SIDED|95.0|0.08|2.65|||ANOVA|||Definition of Improvement (DOI) at week 40||2.65|0.08|0.60
91698744|NCT02347891|183292353|SUPERIORITY||Risk Ratio (RR)|0.6||||0.61|TWO_SIDED|95.0|0.16|1.82|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 40||1.82|0.16|0.61
91698745|NCT02347891|183292353|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 40||1.47|0|0.23
91698746|NCT02347891|183292354|SUPERIORITY|||||||0.92|||||||ANOVA|||Mean Total Improvement Score (TIS) during Randomized Phase at Week 40||||0.92
91698747|NCT02347891|183292355|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Definition of Improvement (DOI) at Week 64||1.47|0|0.23
91698748|NCT02347891|183292355|SUPERIORITY||Risk Ratio (RR)|0.75||||0.99|TWO_SIDED|95.0|0.19|2.51|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 64||2.51|0.19|0.99
91698749|NCT02347891|183292355|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 64||1.47|0|0.23
91698750|NCT02347891|183292356|SUPERIORITY|||||||0.62|||||||ANOVA|||Mean Total Improvement Score (TIS) after Open Label Phase at 64 Week||||0.62
91698751|NCT00614120|183292358|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|-0.06|||<|0.0001||95.0|-0.23|0.11||Non-inferiority; \<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.11|-0.23|<0.0001
91698752|NCT00614120|183292358|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.03|||<|0.0001||95.0|-0.14|0.2||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.20|-0.14|<.0001
91698753|NCT00614120|183292358|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.25||||0.0421||95.0|0.08|0.42||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.42|0.08|0.0421
91730400|NCT04003142|183355930|SUPERIORITY||LSMean difference|-12.16|STANDARD_ERROR_OF_MEAN|3.43|<|0.001||95.0|-18.9|-5.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.43|-18.90|<0.001
91730401|NCT04003142|183355930|SUPERIORITY||LSMean difference|-15.68|STANDARD_ERROR_OF_MEAN|3.44|<|0.001||95.0|-22.44|-8.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-8.91|-22.44|<0.001
91698754|NCT04257032|183292379|OTHER||Ratio of geometric means (T/R) %|105.37|||||TWO_SIDED|90.0|97.94|113.35|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 9.9|Relative bioavailability||113.35|97.94|
91698755|NCT04257032|183292380|OTHER||Ratio of geometric means (T/R) %|114.5|||||TWO_SIDED|90.0|104.22|125.81|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 14.0|Relative bioavailability||125.81|104.22|
91698756|NCT04257032|183292381|OTHER||Ratio of geometric means (T/R) %|108.18|||||TWO_SIDED|90.0|100.26|116.73|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.3|Relative bioavailability||116.73|100.26|
91698757|NCT04257032|183292382|OTHER||Ratio of geometric means (T/R) %|108.89|||||TWO_SIDED|90.0|99.84|118.76|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 12.9|Relative bioavailability||118.76|99.84|
91698758|NCT04257032|183292383|OTHER||Ratio of geometric means (T/R) %|104.52|||||TWO_SIDED|90.0|97.34|112.23|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 10.6|Relative bioavailability||112.23|97.34|
91698759|NCT04257032|183292384|OTHER||Ratio of geometric means (T/R) %|108.42|||||TWO_SIDED|90.0|100.37|117.12|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.5|Relative bioavailability||117.12|100.37|
91698760|NCT00792688|183292388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0062
91698761|NCT00792688|183292388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0331||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0331
91698762|NCT03386994|183292420|OTHER|||||||0.0002|||||||ANOVA|Total annual IPF-related costs||||||0.0002
91698763|NCT03386994|183292420|OTHER|||||||0.0007|||||||ANOVA|Annual direct health IPF-related costs||||||0.0007
91698764|NCT03386994|183292420|OTHER||||||<|0.0001|||||||ANOVA|Annual direct non-health IPF-related costs||||||<0.0001
91698765|NCT03386994|183292420|OTHER|||||||0.6839|||||||ANOVA|Annual indirect IPF-related costs||||||0.6839
91698766|NCT03386994|183292421|OTHER|||||||0.002|||||||Kruskal-Wallis|Timepoint: T0||||||0.0020
91730402|NCT04003142|183355930|SUPERIORITY||LSMean difference|-14.61|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-22.09|-7.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-7.13|-22.09|<0.001
91698767|NCT03386994|183292421|OTHER|||||||0.1385|||||||Kruskal-Wallis|Timepoint: T6||||||0.1385
91698768|NCT03386994|183292421|OTHER|||||||0.0233|||||||Kruskal-Wallis|Timepoint: T12||||||0.0233
91698769|NCT03386994|183292422|OTHER|||||||0.156||||||Timepoint: T0|Kruskal-Wallis|||||||0.1560
91698770|NCT03386994|183292422|OTHER|||||||0.3144||||||Timepoint: T6|Kruskal-Wallis|||||||0.3144
91698771|NCT03386994|183292422|OTHER|||||||0.2019||||||Timepoint: T12|Kruskal-Wallis|||||||0.2019
91698772|NCT03386994|183292423|OTHER|||||||0.0075||||||Timepoint: T0|Kruskal-Wallis|||||||0.0075
91698773|NCT03386994|183292423|OTHER|||||||0.0361||||||Timepoint: T6|Kruskal-Wallis|||||||0.0361
91698774|NCT03386994|183292423|OTHER|||||||0.4794||||||Timepoint: T12|Kruskal-Wallis|||||||0.4794
91698775|NCT03386994|183292424|OTHER|||||||0.0333|||||||Fisher Exact|||||||0.0333
91698776|NCT03386994|183292426|OTHER|||||||0.4711|||||||ANOVA|Total annual IPF-related costs||||||0.4711
91698777|NCT03386994|183292426|OTHER|||||||0.4095|||||||ANOVA|Annual direct health IPF-related costs||||||0.4095
91698778|NCT03386994|183292426|OTHER|||||||0.0435|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0435
91698779|NCT03386994|183292426|OTHER|||||||0.5479|||||||ANOVA|Annual indirect IPF-related costs||||||0.5479
91698780|NCT03386994|183292428|OTHER|||||||0.7486|||||||ANOVA|Total annual IPF-related costs||||||0.7486
91698781|NCT03386994|183292428|OTHER|||||||0.7652|||||||ANOVA|Annual direct health IPF-related costs||||||0.7652
91698782|NCT03386994|183292428|OTHER|||||||0.0037|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0037
91698783|NCT03386994|183292428|OTHER|||||||0.6119|||||||ANOVA|Annual indirect IPF-related costs||||||0.6119
91698784|NCT03386994|183292429|OTHER|||||||0.1581|||||||ANOVA|Total annual IPF-related costs||||||0.1581
91698785|NCT03386994|183292429|OTHER|||||||0.1581|||||||ANOVA|Annual direct health IPF-related costs||||||0.1581
91698786|NCT03386994|183292429|OTHER|||||||0.7165|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.7165
91698787|NCT03386994|183292429|OTHER|||||||1|||||||ANOVA|Annual indirect IPF-related costs||||||1.0000
91698788|NCT03386994|183292430|OTHER|||||||0.0733|||||||Kruskal-Wallis|||||||0.0733
91698789|NCT03386994|183292432|OTHER|||||||0.0207|||||||Kruskal-Wallis|||||||0.0207
91698790|NCT03386994|183292433|OTHER|||||||0.0942|||||||Kruskal-Wallis|||||||0.0942
91698791|NCT03386994|183292434|OTHER|||||||0.0747|||||||Kruskal-Wallis|||||||0.0747
91698792|NCT03386994|183292436|OTHER|||||||0.1282|||||||Kruskal-Wallis|||||||0.1282
91698793|NCT03386994|183292437|OTHER|||||||0.7471|||||||Kruskal-Wallis|||||||0.7471
91698794|NCT03395184|183292480|OTHER||Percentage risk difference|14.3||||0.0119|TWO_SIDED|90.0|4.0|24.5|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum (min) risk weight method (Mehrotra-Railkar 2000)|||24.5|4.0|0.0119
91698795|NCT03395184|183292480|OTHER||Percentage risk difference|21.4||||0.0012|TWO_SIDED|90.0|10.0|32.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||32.9|10.0|0.0012
91730403|NCT04003142|183355930|SUPERIORITY||LSMean difference|-15.95|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-23.45|-8.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-8.45|-23.45|<0.001
91491961|NCT00329238|182856881|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Hazard Ratio (HR)|1.44||||0.0137||95.0|0.78|2.64||p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.|Regression, Cox|HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.|HR for time to first recurrent VTE or VTE death.|||2.64|0.78|0.0137
91491962|NCT00329238|182856881|SUPERIORITY_OR_OTHER|||||||0.2424||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.|Regression, Cox|||||||0.2424
91491963|NCT00329238|182856882|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Risk Difference (RD)|0.38|||<|0.0001||95.0|-0.5|1.25||p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.|Regression, Cox|Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.||||1.25|-0.50|<0.0001
91491964|NCT00329238|182856882|SUPERIORITY_OR_OTHER|||||||0.4013||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.|Kaplan-Meier|||||||0.4013
91491965|NCT00329238|182856883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4732||95.0|0.75|1.84|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent VTE or all cause death.|||1.84|0.75|0.4732
91698796|NCT03395184|183292494|OTHER||Percentage risk difference|13.3||||0.039|TWO_SIDED|90.0|1.0|25.7|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.7|1.0|0.0390
91698797|NCT03395184|183292494|OTHER||Percentage risk difference|29.7||||0.0001|TWO_SIDED|90.0|17.2|42.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||42.2|17.2|0.0001
91698798|NCT03395184|183292495|OTHER||LS mean difference|-3.0||||0.0007|TWO_SIDED|90.0|-4.55|-1.48|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-1.48|-4.55|0.0007
91698799|NCT03395184|183292495|OTHER||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|90.0|-6.62|-3.26|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-3.26|-6.62|<.0001
91491966|NCT00329238|182856884|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.8876||95.0|-1.11|1.28|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.||Dabigatran versus Warfarin||1.28|-1.11|0.8876
91698800|NCT03395184|183292496|OTHER||Percentage risk difference|13.9||||0.0279|TWO_SIDED|90.0|2.1|25.6|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.6|2.1|0.0279
91698801|NCT03395184|183292496|OTHER||Percentage risk difference|31.5|||<|0.0001|TWO_SIDED|90.0|19.1|43.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||43.9|19.1|<.0001
91698802|NCT03395184|183292497|OTHER||Percentage risk difference|2.5||||0.2922|TWO_SIDED|90.0|-4.3|9.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||9.3|-4.3|0.2922
91698803|NCT03395184|183292497|OTHER||Percentage risk difference|7.4||||0.0449|TWO_SIDED|90.0|-0.4|15.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||15.2|-0.4|0.0449
91698804|NCT03395184|183292498|OTHER||Percentage risk difference|5.8||||0.0998|TWO_SIDED|90.0|-1.6|13.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||13.3|-1.6|0.0998
91698805|NCT03395184|183292498|OTHER||Percentage risk difference|11.8||||0.0111|TWO_SIDED|90.0|2.8|20.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||20.9|2.8|0.0111
91698806|NCT02060058|183292501|OTHER|The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.||||||0.01|||||||Chi-squared|||||||0.01
91698807|NCT02017717|183292533|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
91698808|NCT02017717|183292534|SUPERIORITY||Difference of OS rates at 12 months|-0.5||||0.9208|TWO_SIDED|95.0|-10.8|9.7|||Z test with variance estimation based on|Greenwood formula using log(-log) transformation||||9.7|-10.8|0.9208
91698809|NCT02017717|183292536|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|1.5|2.35||||||||2.35|1.50|
91698810|NCT02017717|183292537|SUPERIORITY||Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.15|0.59||||||||0.59|0.15|
91698811|NCT02017717|183292538|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
91698812|NCT00765895|183292562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Mantel Haenszel|Stratified by clinic||||||0.86
91698813|NCT00970632|183292570|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.|ANCOVA|||||||0.001
91698814|NCT00970632|183292570|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.023||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.023
91698815|NCT00970632|183292571|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
91698816|NCT00970632|183292571|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
91698817|NCT00970632|183292572|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
91698818|NCT00970632|183292572|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
91698819|NCT00970632|183292573|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
91698820|NCT00970632|183292573|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.026||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
91698821|NCT00970632|183292574|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.08||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.080
91698822|NCT00970632|183292574|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.118||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.118
91698823|NCT00970632|183292575|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.022||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.022
91698824|NCT00970632|183292575|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.546||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.546
91698825|NCT00970632|183292576|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
91698826|NCT00970632|183292576|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.005
91491967|NCT00329238|182856885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.4548||95.0|0.64|2.71|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent symptomatic DVT|Dabigatran versus Warfarin||2.71|0.64|0.4548
91491968|NCT00329238|182856886|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.19||||0.6563||95.0|-0.63|1.0|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.||Dabigatran versus Warfarin||1.00|-0.63|0.6563
91698827|NCT00970632|183292577|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
91698828|NCT00970632|183292577|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
91698829|NCT00970632|183292578|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
91698830|NCT00970632|183292578|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.026||95.0||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
91698831|NCT00970632|183292579|SUPERIORITY_OR_OTHER|||||||0.001||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.001
91698832|NCT00970632|183292579|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.114
91698833|NCT00970632|183292580|SUPERIORITY_OR_OTHER|||||||0.004||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.004
91491969|NCT00329238|182856887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04||||0.1925||95.0|0.7|5.98|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.|Dabigatran versus Warfarin||5.98|0.70|0.1925
91698834|NCT00970632|183292580|SUPERIORITY_OR_OTHER|||||||0.452||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.452
91698835|NCT00970632|183292581|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-4.4||||0.005||||||The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.005
91698836|NCT00970632|183292581|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-2.2||||0.457||||||The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.457
91698837|NCT00970632|183292582|SUPERIORITY_OR_OTHER||Difference in LS Means|4.0|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||<0.001
91698838|NCT00970632|183292582|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.699||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||0.699
91698839|NCT00970632|183292583|SUPERIORITY_OR_OTHER|||||||0.009||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.009
91698840|NCT00970632|183292583|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.014
91698841|NCT00970632|183292586|SUPERIORITY_OR_OTHER|||||||0.303||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.303
91698842|NCT00970632|183292586|SUPERIORITY_OR_OTHER|||||||0.146||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.146
91698843|NCT03192995|183292587|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
91698844|NCT03192995|183292588|SUPERIORITY|||||||0.53|||||||Fisher Exact|||||||0.53
91698845|NCT03192995|183292589|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||.32
91698846|NCT03192995|183292590|SUPERIORITY|||||||0.541|||||||Fisher Exact|||||||.541
91698847|NCT03192995|183292591|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.24|3.82||||||||3.82|0.24|
91491970|NCT00329238|182856888|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26||||0.3723||95.0|-0.32|0.84|||Kaplan-Meier||Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18|Dabigatran versus Warfarin||0.84|-0.32|0.3723
91698848|NCT01286168|183292602|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.02
91698849|NCT01286168|183292603|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.03
91698850|NCT01286168|183292604|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|||Antisepsis and Control sides were compared.||||0.003
91698851|NCT01286168|183292605|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.13
91698852|NCT01286168|183292606|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.45
91698853|NCT01286168|183292607|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.02
91698854|NCT01286168|183292607|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.02
91698855|NCT01286168|183292608|SUPERIORITY_OR_OTHER|||||||0.004|||||||Likelihood-ratio test|||Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.||||0.004
91698856|NCT01286168|183292609|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.003
91698857|NCT01286168|183292609|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.003
91698858|NCT01871402|183292691|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
91698859|NCT01871402|183292692|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
91698860|NCT01871402|183292693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91698861|NCT01871402|183292694|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
91698862|NCT04594941|183292697|OTHER||Least Sqaure (LS) Mean Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.754||0.8452|TWO_SIDED|90.0|-1.431|1.133|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.133|-1.431|0.8452
91698863|NCT04594941|183292697|OTHER||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|1.109||0.989|TWO_SIDED|90.0|-1.899|1.868|||Mixed-effects model for repeated measure|||"SPE VS HPLC: Reader 1~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.868|-1.899|0.9890
91698864|NCT04594941|183292697|OTHER||LS Mean Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.854||0.3852|TWO_SIDED|90.0|-2.204|0.698|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||0.698|-2.204|0.3852
91698865|NCT04594941|183292697|OTHER||LS Mean Difference|-0.091|STANDARD_ERROR_OF_MEAN|0.968||0.926|TWO_SIDED|90.0|-1.735|1.554|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.554|-1.735|0.9260
91698866|NCT04594941|183292698|OTHER||LS Mean Difference|-0.219|STANDARD_ERROR_OF_MEAN|1.109||0.8452|TWO_SIDED|90.0|-2.104|1.667|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.667|-2.104|0.8452
91730404|NCT04003142|183355930|SUPERIORITY||LSMean difference|-15.51|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-23.16|-7.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-7.86|-23.16|<0.001
91698867|NCT04594941|183292698|OTHER||Least Square Mean (LSM) Difference|-0.023|STANDARD_ERROR_OF_MEAN|1.63||0.989|TWO_SIDED|90.0|-2.793|2.747|||Mixed-effects model for repeated measure|||"Reader 1: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.747|-2.793|0.9890
91698868|NCT04594941|183292698|OTHER||LS Mean Difference|-1.107|STANDARD_ERROR_OF_MEAN|1.256||0.3852|TWO_SIDED|90.0|-3.241|1.027|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.027|-3.241|0.3852
91698869|NCT04594941|183292698|OTHER||LS Mean Difference|-0.133|STANDARD_ERROR_OF_MEAN|1.424||0.926|TWO_SIDED|90.0|-2.552|2.285|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.285|-2.552|0.9260
91698870|NCT04594941|183292699|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||<0.0001
91698871|NCT04594941|183292699|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
91698872|NCT04594941|183292699|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
91698873|NCT04594941|183292699|OTHER|||||||0.0072|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0072
91698874|NCT04594941|183292699|OTHER|||||||0.0051|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0051
91698875|NCT04594941|183292699|OTHER|||||||0.0023|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0023
91698876|NCT04594941|183292699|OTHER|||||||0.0002|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0002
91730405|NCT04003142|183355930|SUPERIORITY||LSMean difference|-20.25|STANDARD_ERROR_OF_MEAN|3.9|<|0.001||95.0|-27.91|-12.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-12.59|-27.91|<0.001
91698877|NCT04594941|183292699|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
91730406|NCT04003142|183355930|SUPERIORITY||LSMean difference|-16.34|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-24.04|-8.63||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-8.63|-24.04|<0.001
91730407|NCT04003142|183355930|SUPERIORITY||LSMean difference|-21.65|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-29.36|-13.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.94|-29.36|<0.001
91730408|NCT04003142|183355930|SUPERIORITY||LSMean difference|-15.62|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-23.27|-7.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-7.98|-23.27|<0.001
91730409|NCT04003142|183355930|SUPERIORITY||LSMean difference|-22.88|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-30.52|-15.24||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-15.24|-30.52|<0.001
91730410|NCT04003142|183355930|SUPERIORITY||LSMean difference|-14.78|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-22.38|-7.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-7.19|-22.38|<0.001
91730411|NCT04003142|183355930|SUPERIORITY||LSMean difference|-22.66|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-30.25|-15.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-15.07|-30.25|<0.001
91491971|NCT00329238|182856889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9921||95.0|0.06|16.22|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to deaths related to VTE.|Dabigatran versus Warfarin||16.22|0.06|0.9921
91491972|NCT00329238|182856890|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.9204||95.0|-0.2|0.23|||Kaplan-Meier|Risk difference for the time to deaths related to VTE at Month 18.||Dabigatran versus Warfarin||0.23|-0.20|0.9204
91698878|NCT04594941|183292699|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
91698879|NCT04594941|183292700|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0089
91698880|NCT04594941|183292700|OTHER|||||||0.0207|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0207
91698881|NCT04594941|183292700|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0089
91698882|NCT04594941|183292700|OTHER|||||||0.732|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.732
91698883|NCT04594941|183292700|OTHER|||||||0.0083|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0083
91698884|NCT04594941|183292700|OTHER|||||||0.0412|||||||Wilcoxon (Mann-Whitney)|||Reader 3||||0.0412
91698885|NCT04594941|183292700|OTHER|||||||0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0001
91698886|NCT04594941|183292700|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
91698887|NCT04594941|183292700|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
91730412|NCT04003142|183355930|SUPERIORITY||LSMean difference|-14.97|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-22.86|-7.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-7.09|-22.86|<0.001
91730413|NCT04003142|183355930|SUPERIORITY||LSMean difference|-21.47|STANDARD_ERROR_OF_MEAN|4.01|<|0.001||95.0|-29.34|-13.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.60|-29.34|<0.001
91730414|NCT04003142|183355930|SUPERIORITY||LSMean difference|-14.38|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-22.33|-6.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-6.43|-22.33|<0.001
91730415|NCT04003142|183355930|SUPERIORITY||LSMean difference|-20.57|STANDARD_ERROR_OF_MEAN|4.03|<|0.001||95.0|-28.5|-12.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.65|-28.50|<0.001
91730416|NCT04003142|183355930|SUPERIORITY||LSMean difference|-12.14|STANDARD_ERROR_OF_MEAN|4.07||0.003||95.0|-20.14|-4.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-4.14|-20.14|0.003
91730417|NCT04003142|183355930|SUPERIORITY||LSMean difference|-19.73|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.71|-11.755||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-11.755|-27.71|<0.001
91730418|NCT04003142|183355930|SUPERIORITY||LSMean difference|-14.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-22.25|-6.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-6.54|-22.25|<0.001
91698888|NCT04594941|183292702|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|1.0000|
91698889|NCT04594941|183292702|OTHER||Kappa Statistics|0.6957|||||TWO_SIDED|95.0|0.1696|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.1696|
91698890|NCT04594941|183292702|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
91698891|NCT04594941|183292702|OTHER||Kappa Statistics|0.4615|||||TWO_SIDED|95.0|-0.0699|0.993|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||0.9930|-0.0699|
91698892|NCT04594941|183292702|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|1.0000|
91698893|NCT04594941|183292702|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
91698894|NCT04594941|183292702|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|0.6567|
91698895|NCT04594941|183292702|OTHER||Kappa Statistics|0.8828|||||TWO_SIDED|95.0|0.6614|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.6614|
91491973|NCT00329238|182856891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7405||95.0|0.47|1.72|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to all deaths|Dabigatran versus Warfarin||1.72|0.47|0.7405
91491974|NCT00329238|182856892|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9622||95.0|-0.89|0.84|||Kaplan-Meier|Risk difference for the time to all deaths at Month 18.||Dabigatran versus Warfarin||0.84|-0.89|0.9622
91528452|NCT04711460|182932219|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.04||0.101|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.101
91730419|NCT04003142|183355930|SUPERIORITY||LSMean difference|-20.1|STANDARD_ERROR_OF_MEAN|3.98|<|0.001||95.0|-27.93|-12.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-12.27|-27.93|<0.001
91698896|NCT04594941|183292702|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|0.6567|
91698897|NCT03408444|183292709|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.063|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.106|-0.02|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.020|-0.106|
91698898|NCT03408444|183292709|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0183|||TWO_SIDED|95.0|-0.1|-0.013|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.013|-0.100|
91698899|NCT03408444|183292709|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.105|STANDARD_ERROR_OF_MEAN|0.0184|||TWO_SIDED|95.0|-0.149|-0.062|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.062|-0.149|
91698900|NCT03408444|183292710|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|Kenward and Roger method was for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.21|-0.04|
91698901|NCT03408444|183292710|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.01|0.25|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.25|-0.01|
91730420|NCT04003142|183355930|SUPERIORITY||LSMean difference|-14.96|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-22.96|-6.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-6.96|-22.96|<0.001
91491975|NCT00329238|182856893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0577||95.0|0.27|1.02|||Regression, Cox||This is the analysis of the time to the first MBE.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||1.02|0.27|0.0577
91730421|NCT04003142|183355930|SUPERIORITY||LSMean difference|-20.15|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.13|-12.18||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.18|-28.13|<0.001
91491976|NCT00329238|182856893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||0.83|0.61|<0.0001
91491977|NCT00959764|182856898|NON_INFERIORITY_OR_EQUIVALENCE|"Assumed placebo-adjusted effect for both active treatment groups (% increase in BMD)was 1.56% and that the placebo adjusted effect for the rsCT tablets must be at least 0.5 times the placebo adjusted effect for the calcitonin nasal spray (active control treatment group). The null hypothesis to be tested was:~\[Mean(oral) - Mean(placebo)\] - 0.5 x \[Mean(nasal) - Mean(placebo)\] \< 0. Reference Pigeot, et al. 2003"|Mean Difference (Net)|0.77|STANDARD_DEVIATION|2.5||0.002|TWO_SIDED|95.0|0.08|1.45||The P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05|ANCOVA|||The overall analysis across groups was an Analysis of Covariance where the study was powered to 80% with an assumption of a standard deviation of 2.5% and a two-sided 5% level of significance. For each treatment group, the BMD at 48 weeks was compared with the BMD at baseline and a % increase was calculated (baseline = 0%). This difference was subjected to the t-test. Two-sided P-value is less than or equal to 0.05 and was not adjusted as multiple comparisons were not done.||1.45|0.08|0.002
91491978|NCT00959764|182856899|NON_INFERIORITY_OR_EQUIVALENCE|Same as for Primary Outcome|Mean Difference (Net)|-21.84|STANDARD_DEVIATION|41.99||0.0006||||||P-value not adjusted for multiple comparisons; a priori threshold for significance was 0.05|ANCOVA|95% confidence interval not calculated||Same as for Primary Outcome||||0.0006
91491979|NCT00959764|182856900|NON_INFERIORITY_OR_EQUIVALENCE|Same as Primary Outcome|Mean Difference (Net)|-18.09|STANDARD_DEVIATION|47.53||0.0012||||||p-value not adjusted for multiple comparisons; a priori threshold for statistical significance was set at 0.05.|ANCOVA||oral calcitonin vs placebo|Same as Primary Outcome||||0.0012
91491980|NCT02284516|182856901|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.16|STANDARD_ERROR_OF_MEAN|2.096|=|0.0007|TWO_SIDED|95.0|3.04|11.28||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||||11.28|3.04|=0.0007
91698902|NCT03408444|183292710|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|0.09|0.35|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.35|0.09|
91698903|NCT02045862|183292801|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.21||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.69|<0.001
91491981|NCT02284516|182856902|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.85|STANDARD_ERROR_OF_MEAN|1.792|<|0.0001|TWO_SIDED|95.0|4.33|11.37||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 14||11.37|4.33|<0.0001
91491982|NCT02284516|182856902|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|9.32|STANDARD_ERROR_OF_MEAN|1.976|<|0.0001|TWO_SIDED|95.0|5.44|13.2||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 42||13.20|5.44|<0.0001
91491983|NCT00864383|182856903|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.|Adjusted difference in proportions|6.1|||||TWO_SIDED|97.5|1.7|10.5|||||Adjusted difference from control in proportion of unfavorable outcome - percentage points|||10.5|1.7|
91491984|NCT00864383|182856903|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the proportion of patients with an unfavorable outcome.|Adjusted difference from control|11.4|||||TWO_SIDED|97.5|6.7|16.1|||||Adjusted difference from control in rate of unfavorable outcome- percentage points|||16.1|6.7|
91491985|NCT03344796|182856934|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91698904|NCT02045862|183292801|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.37|0.11||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.11|-0.37|0.002
91491986|NCT03344796|182856935|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
91698905|NCT02045862|183292802|SUPERIORITY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.77|-0.2||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.77|<0.001
91698906|NCT02045862|183292802|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.71|-0.13||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.13|-0.71|0.004
91698907|NCT02045862|183292803|SUPERIORITY||Least Squares Mean Difference|15.84|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|8.99|22.69|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||22.69|8.99|<0.001
91698908|NCT02045862|183292803|SUPERIORITY||Least Squares Mean Difference|12.77|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|5.98|19.57|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||19.57|5.98|<0.001
91730422|NCT04003142|183355930|SUPERIORITY||LSMean difference|-13.64|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-21.62|-5.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-5.65|-21.62|<0.001
91730423|NCT04003142|183355930|SUPERIORITY||LSMean difference|-18.94|STANDARD_ERROR_OF_MEAN|4.05|<|0.001||95.0|-26.89|-10.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-10.98|-26.89|<0.001
91491987|NCT03344796|182856936|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91698909|NCT02045862|183292804|SUPERIORITY||Least Squares Mean Difference|-7.55|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-10.05|-5.05|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-5.05|-10.05|<0.001
91698910|NCT02045862|183292804|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-7.09|-2.12|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-2.12|-7.09|<0.001
91730424|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|1.881||||0.02||95.0|1.11|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||3.233|1.110|0.020
91730425|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.645|||<|0.001|TWO_SIDED|95.0|1.585|4.498||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||4.498|1.585|<0.001
91730426|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001||95.0|1.535|4.001||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.001|1.535|<0.001
91491988|NCT03344796|182856937|SUPERIORITY||||||<|0.1|||||||Chi-squared|||Knowledge of sun protection score at baseline compared with score after completion of the arm. The hypothesis is that the focus group, usability test and structured interviews arms will not have significant change in knowledge. It is expected that cohort studies 1 and 2 will have significant change in knowledge of sun protection.||||< 0.1
91491989|NCT02516046|182856967|OTHER||Fleiss' kappa|0.8|||||TWO_SIDED|95.0|0.74|0.86||||||Inter-reader agreement analysis using Fleiss' kappa. The hypothesis tested was that the observed kappa values were ≥0.64 and the lower bound of the 2-sided 95% CIs were ≥0.55 for the inter-reader agreement among readers.||0.86|0.74|
91698911|NCT02045862|183292805|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.28|0.82|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.82|0.28|<0.001
91698912|NCT02045862|183292805|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.32|0.86|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.86|0.32|<0.001
91730427|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001|TWO_SIDED|95.0|1.534|4.004||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.004|1.534|<0.001
91698913|NCT02045862|183292807|SUPERIORITY||Rate Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.54|0.84|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.84|0.54|<0.001
91698914|NCT02045862|183292807|SUPERIORITY||Rate Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.12||0.029|TWO_SIDED|95.0|0.61|0.97|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.97|0.61|0.029
91491990|NCT03137537|182856980|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91491991|NCT03137537|182856981|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91730428|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.367|||<|0.001||95.0|1.502|3.762||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.762|1.502|<0.001
91730429|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.894|||<|0.001||95.0|1.835|4.609||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||4.609|1.835|<0.001
91491992|NCT01211730|182856989|SUPERIORITY_OR_OTHER|||||||0.709|||||||Chi-squared, Corrected|||||||0.709
91491993|NCT01211730|182856990|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared, Corrected|||||||0.003
91491994|NCT01211730|182856991|SUPERIORITY_OR_OTHER|||||||0.0046|||||||Chi-squared, Corrected|||||||0.0046
91491995|NCT01211730|182856992|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||||||0.75
91491996|NCT01211730|182856993|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared, Corrected|||||||0.56
91491997|NCT01211730|182856994|SUPERIORITY_OR_OTHER|||||||0.77|||||||Chi-squared, Corrected|||||||0.77
91513260|NCT02710630|182898019|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|109.85|STANDARD_DEVIATION|38.7|||TWO_SIDED|90.0|94.452|127.75|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.750|94.452|
91698915|NCT02045862|183292808|SUPERIORITY||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.76|-1.49||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.49|-4.76|<0.001
91698916|NCT02045862|183292808|SUPERIORITY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-2.57|0.72||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.72|-2.57|<0.001
91698917|NCT02045862|183292809|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.01|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate||2.01|1.26|<0.001
91698918|NCT02045862|183292809|SUPERIORITY||Odds Ratio (OR)|1.38||||0.009|TWO_SIDED|95.0|1.08|1.75|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.||1.75|1.08|0.009
91698919|NCT02045862|183292810|SUPERIORITY||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.05|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||2.05|1.26|<0.001
91698920|NCT02045862|183292810|SUPERIORITY||Odds Ratio (OR)|1.45||||0.002|TWO_SIDED|95.0|1.14|1.85|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||1.85|1.14|0.002
91698921|NCT02045862|183292811|SUPERIORITY||Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.65|-0.21||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.65|<0.001
91698922|NCT02045862|183292811|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.009|TWO_SIDED|95.0|-0.36|0.09||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate||0.09|-0.36|0.009
91698923|NCT02045862|183292812|SUPERIORITY||Rate Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|0.48|0.79|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable||0.79|0.48|<0.001
91698924|NCT02045862|183292812|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|95.0|0.58|0.96|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable||0.96|0.58|0.023
91698925|NCT02045862|183292813|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.51|-1.46||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.46|-4.51|<0.001
91730430|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.902|||<|0.001|TWO_SIDED|95.0|1.829|4.657||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.657|1.829|<0.001
91730431|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|3.218|||<|0.001||95.0|2.025|5.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.172|2.025|<0.001
91730432|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.153|||<|0.001||95.0|1.375|3.394||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.394|1.375|<0.001
91698926|NCT02045862|183292813|SUPERIORITY||Stratified Rank ANCOVA|-0.93|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-2.47|0.61||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.61|-2.47|0.006
91698927|NCT02045862|183292815|SUPERIORITY||Odds Ratio (OR)|1.44||||0.002|TWO_SIDED|95.0|1.14|1.8|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.8|1.14|0.002
91698928|NCT02045862|183292815|SUPERIORITY||Odds Ratio (OR)|1.37||||0.007|TWO_SIDED|95.0|1.09|1.73|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.73|1.09|0.007
91698929|NCT02045862|183292816|SUPERIORITY||Least Squares Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.16|-0.41|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.41|-1.16|<0.001
91698930|NCT02045862|183292816|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.037|TWO_SIDED|95.0|-0.77|-0.02|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.02|-0.77|0.037
91698931|NCT02045862|183292818|SUPERIORITY||Least Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.37|-1.10|<0.001
91698932|NCT02045862|183292818|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.036|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.03|-0.76|0.036
91698933|NCT02045862|183292819|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.059|TWO_SIDED|95.0|-0.19|0.0|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.00|-0.19|0.059
91698934|NCT02045862|183292819|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.068|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.068
91698935|NCT02045862|183292820|SUPERIORITY||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.067|TWO_SIDED|95.0|0.81|1.01|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable||1.01|0.81|0.067
91730433|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|3.074|||<|0.001||95.0|1.957|4.878||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||4.878|1.957|<0.001
91730434|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.05||||0.002||95.0|1.31|3.228||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.228|1.310|0.002
91730435|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.908|||<|0.001||95.0|1.856|4.599||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.599|1.856|<0.001
91491998|NCT02465515|182856995|NON_INFERIORITY|Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p \<0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3)|Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.68|0.9||One-sided p-value based on Wald test of hazard ratio (HR) \>=1.3 versus HR \<1.3.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||0.90|0.68|<0.0001
91491999|NCT02465515|182856995|SUPERIORITY||||||<|0.001||||||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test|||||||<0.001
91492000|NCT02465515|182856996|OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.69|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.69|<0.001
91492001|NCT02465515|182856997|OTHER||Hazard Ratio (HR)|0.93||||0.578|TWO_SIDED|95.0|0.73|1.19||Two-sided p-value based on the Wald statistic|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||1.19|0.73|0.578
91492002|NCT02465515|182856998|OTHER||Hazard Ratio (HR)|0.75||||0.003|TWO_SIDED|95.0|0.61|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.61|0.003
91492003|NCT02465515|182856999|OTHER||Hazard Ratio (HR)|0.86||||0.3|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.14|0.66|0.300
91492004|NCT02465515|182857000|OTHER||Hazard Ratio (HR)|0.85||||0.113|TWO_SIDED|95.0|0.7|1.04||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.04|0.70|0.113
91492005|NCT02465515|182857001|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.53||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.53|0.33|<0.001
91492006|NCT02465515|182857002|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.043|TWO_SIDED|95.0|0.51|0.99||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.99|0.51|0.043
91492007|NCT02465515|182857003|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 8||||||<0.001
91492008|NCT02465515|182857003|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 16||||||<0.001
91492009|NCT02465515|182857003|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 24||||||<0.001
91698936|NCT02045862|183292820|SUPERIORITY||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.06||0.131||95.0|0.82|1.03|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.||1.03|0.82|0.131
91492010|NCT02465515|182857003|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Final assessment||||||<0.001
91492011|NCT02465515|182857004|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.055|TWO_SIDED|95.0|0.43|1.01||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.01|0.43|0.055
91492012|NCT02465515|182857005|OTHER||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.58||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.58|-0.69|<0.001
91492013|NCT02465515|182857005|OTHER||Mean Difference (Net)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.58|-0.45||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.45|-0.58|<0.001
91492014|NCT02465515|182857006|OTHER||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.83|-0.49||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.49|-0.83|<0.001
91513261|NCT02710630|182898020|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.69|STANDARD_DEVIATION|40.2|||TWO_SIDED|90.0|98.783|135.491|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.491|98.783|
91513262|NCT02710630|182898020|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|50.43|STANDARD_DEVIATION|173.7|||TWO_SIDED|90.0|31.519|80.689|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||80.689|31.519|
91698937|NCT02045862|183292821|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.055|TWO_SIDED|95.0|-1.34|0.01|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-1.34|0.055
91698938|NCT02045862|183292821|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.048|TWO_SIDED|95.0|-1.39|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-1.39|0.048
91698939|NCT02045862|183292822|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|-0.69|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.69|0.002
91698940|NCT02045862|183292822|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.039|TWO_SIDED|95.0|-0.55|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.55|0.039
91698941|NCT02045862|183292823|SUPERIORITY||Rate Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.45|0.76|||Negative Binomial Regression|||Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.76|0.45|<0.001
91698942|NCT02045862|183292823|SUPERIORITY||Rate Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.14||0.044|TWO_SIDED|95.0|0.58|0.99|||Negative Binomial Regression|||Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.99|0.58|0.044
91698943|NCT02045862|183292824|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.92||0.001|TWO_SIDED|95.0|-4.78|-1.18|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.18|-4.78|0.001
91698944|NCT02045862|183292824|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.072|TWO_SIDED|95.0|-3.52|0.15|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.15|-3.52|0.072
91698945|NCT02045862|183292826|SUPERIORITY||Least Squares Mean Difference|4.76|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.56|6.96|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.96|2.56|<0.001
91698946|NCT02045862|183292826|SUPERIORITY||Least Squares Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|1.11||0.01|TWO_SIDED|95.0|0.68|5.04|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.04|0.68|0.010
91698947|NCT02045862|183292827|SUPERIORITY||Least Squares Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|2.99|8.2|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||8.20|2.99|<0.001
91698948|NCT02045862|183292827|SUPERIORITY||Least Squares Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|1.32||0.022|TWO_SIDED|95.0|0.43|5.6|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.60|0.43|0.022
91730436|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.113||||0.001||95.0|1.349|3.332||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.332|1.349|0.001
91698949|NCT02045862|183292828|SUPERIORITY||Least Squares Mean Difference|5.01|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|2.65|7.38|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.38|2.65|<0.001
91698950|NCT02045862|183292828|SUPERIORITY||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|1.43|6.13|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.13|1.43|0.002
91698951|NCT02045862|183292829|SUPERIORITY||Least Squares Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|2.47|7.83|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.83|2.47|<0.001
91698952|NCT02045862|183292829|SUPERIORITY||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|1.35||0.016|TWO_SIDED|95.0|0.62|5.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.93|0.62|0.016
91698953|NCT02045862|183292830|SUPERIORITY||Least Squares Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.98||0.006|TWO_SIDED|95.0|0.77|4.59|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||4.59|0.77|0.006
91698954|NCT02045862|183292830|SUPERIORITY||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.97||0.287|TWO_SIDED|95.0|-0.87|2.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||2.93|-0.87|0.287
91698955|NCT02045862|183292832|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.47|<0.001
91698956|NCT02045862|183292832|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.36|-0.05|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.05|-0.36|0.011
91698957|NCT02045862|183292844|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.26|2.15|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.15|1.26|<0.001
91698958|NCT02045862|183292844|SUPERIORITY||Odds Ratio (OR)|1.27||||0.08|TWO_SIDED|95.0|0.97|1.67|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.67|0.97|0.080
91698959|NCT02045862|183292845|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.001|TWO_SIDED|95.0|1.49|2.78|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.78|1.49|<0.001
91698960|NCT02045862|183292845|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.37|2.57|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.57|1.37|<0.001
91698961|NCT02045862|183292846|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.36|2.43|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.43|1.36|<0.001
91730437|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.594|||<|0.001||95.0|1.653|4.104||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.104|1.653|<0.001
91730438|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|1.891||||0.005|TWO_SIDED|95.0|1.21|2.973||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||2.973|1.210|0.005
91698962|NCT02045862|183292846|SUPERIORITY||Odds Ratio (OR)|1.44||||0.014|TWO_SIDED|95.0|1.08|1.92|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||1.92|1.08|0.014
91492015|NCT02465515|182857006|OTHER||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.6||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.60|-1.06|<0.001
91492016|NCT02465515|182857007|OTHER||Mean Difference (Net)|2.39|||<|0.001|TWO_SIDED|95.0|1.85|2.93||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||2.93|1.85|<0.001
91492017|NCT02465515|182857007|OTHER||Mean Difference (Net)|2.33|||<|0.001|TWO_SIDED|95.0|1.66|3.01||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||3.01|1.66|<0.001
91492018|NCT02465515|182857008|OTHER||Mean Difference (Net)|1.47|||<|0.001|TWO_SIDED|95.0|0.87|2.07||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||2.07|0.87|<0.001
91492019|NCT02465515|182857008|OTHER||Mean Difference (Net)|0.52||||0.192|TWO_SIDED|95.0|-0.26|1.31||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16|||1.31|-0.26|0.192
91698963|NCT02045862|183292847|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.34|2.41|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.41|1.34|<0.001
91698964|NCT02045862|183292847|SUPERIORITY||Odds Ratio (OR)|1.44||||0.019|TWO_SIDED|95.0|1.06|1.95|||Regression, Logistic|||Odds ratio wa from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.06|0.019
91698965|NCT02045862|183292848|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.26|2.19|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.19|1.26|<0.001
91698966|NCT02045862|183292848|SUPERIORITY||Odds Ratio (OR)|1.23||||0.133|TWO_SIDED|95.0|0.94|1.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.62|0.94|0.133
91698967|NCT02045862|183292849|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.18|2.03|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.03|1.18|0.002
91698968|NCT02045862|183292849|SUPERIORITY||Odds Ratio (OR)|1.48||||0.006|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.95|1.12|0.006
91698969|NCT02045862|183292850|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.24|2.29|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.29|1.24|<0.001
91698970|NCT02045862|183292850|SUPERIORITY||Odds Ratio (OR)|1.29||||0.109|TWO_SIDED|95.0|0.94|1.77|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||1.77|0.94|0.109
91698971|NCT02045862|183292851|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.26|2.25|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.25|1.26|<0.001
91698972|NCT02045862|183292851|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.22|2.16|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.16|1.22|<0.001
91698973|NCT02045862|183292852|SUPERIORITY||Odds Ratio (OR)|1.99|||<|0.001|TWO_SIDED|95.0|1.5|2.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.62|1.50|<0.001
91492020|NCT02465515|182857009|OTHER||Hazard Ratio (HR)|0.95||||0.644|TWO_SIDED|95.0|0.79|1.16||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.16|0.79|0.644
91698974|NCT02045862|183292852|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.35|2.36|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.36|1.35|<0.001
91698975|NCT02045862|183292853|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.46|2.54|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.54|1.46|<0.001
91492021|NCT02465515|182857013|OTHER||Mean Difference (Net)|-1.11||||0.003|TWO_SIDED|95.0|-1.84|-0.39||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||-0.39|-1.84|0.003
91492022|NCT02465515|182857013|OTHER||Mean Difference (Net)|-0.43||||0.315|TWO_SIDED|95.0|-1.26|0.41||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16.|||0.41|-1.26|0.315
91492023|NCT00453063|182857018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
91492024|NCT00453063|182857019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304||95.0|||||ANCOVA|||||||0.304
91528453|NCT00192023|182932222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to Week 8 Endpoint. Change = Endpoint minus baseline. Model: Change to Week 8=score at Week 8+treatment+site+treatment-by-site interaction. If treatment-by-site interaction isn't significant it will be removed from model.|ANCOVA|||Using an estimate of the common standard deviation of 13 points, the planned sample size will give about 80% power to detect a difference between the groups of 8 points on the SNAP-IV. The sample size was determined using a two-sided test with p=0.05, and assumes that up to 10% of patients will discontinue the study without providing post-baseline efficacy data in Study Period III.||||<0.001
91528454|NCT00192023|182932223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
91528455|NCT00192023|182932224|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.001
91528456|NCT00192023|182932225|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.836
91528457|NCT00192023|182932226|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.870
91492025|NCT00453063|182857020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
91528458|NCT00192023|182932227|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
91528459|NCT00192023|182932227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
91698976|NCT02045862|183292853|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.2|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.09|1.20|0.001
91528460|NCT00192023|182932227|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.022
91492026|NCT00453063|182857021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||ANCOVA|||||||0.063
91492027|NCT00453063|182857022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356||95.0|||||ANCOVA|||||||0.356
91492028|NCT01918774|182857032|OTHER|Pre-post analysis comparing weeks worked in the 6 months preceding baseline and the 6 month study follow-up.|||||<|0.001||||||A priori threshold of significance was p\<.05|within groups t-test|||||||<.001
91492029|NCT03000439|182857050|OTHER||Hazard Ratio (HR)|0.633|||=|0.1171|TWO_SIDED|95.0|0.296|1.354||1-sided p-value is provided.|Unstratified log-rank test||Hazard ratio and 95% CI was based on Cox proportional hazards model with treatment group as covariate. Hazard ratio \< 1 indicates a reduction in hazard ratio in favor of Tofacitinib 5 mg BID to Placebo.|||1.354|0.296|= 0.1171
91492030|NCT03000439|182857051|OTHER||Difference in percentage|0.7|||||TWO_SIDED|95.0|-12.2|13.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 4||13.6|-12.2|
91492031|NCT03000439|182857051|OTHER||Difference in percentage|-8.3|||||TWO_SIDED|95.0|-27.9|11.3|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 8||11.3|-27.9|
91528461|NCT00192023|182932227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
91528462|NCT00192023|182932228|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.071
91698977|NCT02045862|183292854|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||2.26|1.28|<0.001
91698978|NCT02045862|183292854|SUPERIORITY||Odds Ratio (OR)|1.4||||0.019|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||1.86|1.06|0.019
91698979|NCT02045862|183292855|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.46|1.40|<0.001
91492032|NCT03000439|182857051|OTHER||Difference in percentage|-10.8|||||TWO_SIDED|95.0|-33.2|11.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 12||11.6|-33.2|
91492033|NCT03000439|182857051|OTHER||Difference in percentage|-13.7|||||TWO_SIDED|95.0|-37.2|9.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 16||9.8|-37.2|
91492034|NCT03000439|182857051|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 20||11.5|-37.9|
91698980|NCT02045862|183292855|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.19|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.09|1.19|0.001
91730439|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|3.314|||<|0.001||95.0|2.108|5.265||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.265|2.108|<0.001
91730440|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|1.646||||0.027||95.0|1.06|2.566||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||2.566|1.060|0.027
91730441|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.347|||<|0.001||95.0|1.507|3.683||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.683|1.507|<0.001
91730442|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|1.792||||0.01|TWO_SIDED|95.0|1.153|2.799||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||2.799|1.153|0.010
91492035|NCT03000439|182857051|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 24||11.5|-37.9|
91492036|NCT03000439|182857051|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-34.5|15.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 28||15.6|-34.5|
91492037|NCT03000439|182857051|OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-39.5|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 32||11.5|-39.5|
91492038|NCT03000439|182857051|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 36||16.7|-35.5|
91492039|NCT03000439|182857051|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 40||16.7|-35.5|
91492040|NCT03000439|182857051|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 44||11.8|-41.8|
91528463|NCT00192023|182932229|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
91730443|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.819|||<|0.001||95.0|1.805|4.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.441|1.805|<0.001
91730444|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.357|||<|0.001||95.0|1.513|3.699||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.699|1.513|<0.001
91730445|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|3.131|||<|0.001||95.0|1.999|4.95||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.950|1.999|<0.001
91730446|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|1.373||||0.152||95.0|0.891|2.122||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.122|0.891|0.152
91730447|NCT04003142|183355931|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.001||95.0|1.351|3.252||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||3.252|1.351|<0.001
91730448|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|0.915||||0.951||95.0|0.036|23.464||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||23.464|0.036|0.951
91698981|NCT02045862|183292856|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.33|2.34|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.34|1.33|<0.001
91698982|NCT02045862|183292856|SUPERIORITY||Odds Ratio (OR)|1.43||||0.012|TWO_SIDED|95.0|1.08|1.89|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.89|1.08|0.012
91698983|NCT02004886|183292891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.9|||<|0.001|TWO_SIDED|95.0|-38.4|-13.3|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.3|-38.4|<0.001
91698984|NCT02004886|183292891|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-53.6|||<|0.001|TWO_SIDED|95.0|-66.1|-41.1|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-41.1|-66.1|<0.001
91698985|NCT02004886|183292891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-38.4|-13.6|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.6|-38.4|<0.001
91698986|NCT02004886|183292894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.04|TWO_SIDED|95.0|-35.7|-0.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-0.9|-35.7|0.04
91698987|NCT02004886|183292894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|||<|0.001|TWO_SIDED|95.0|-60.9|-26.3|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-26.3|-60.9|<0.001
91698988|NCT02004886|183292894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.32|TWO_SIDED|95.0|-25.7|8.5|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||8.5|-25.7|0.320
91698989|NCT02004886|183292896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.751|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.751
91730449|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.889||||0.362|TWO_SIDED|95.0|0.364|58.864||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||58.864|0.364|0.362
91528464|NCT00192023|182932229|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.113
91528465|NCT00192023|182932229|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.051
91528466|NCT00192023|182932229|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.061
91528467|NCT02572817|182932236|SUPERIORITY||Odds Ratio (OR)|1.22||||0.54|TWO_SIDED|95.0|0.65|2.29|||Regression, Logistic|||||2.29|0.65|0.54
91698990|NCT02004886|183292896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.581|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||||0.6|-1.0|0.581
91698991|NCT02004886|183292896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.918|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||||0.8|-0.8|0.918
91698992|NCT02004886|183292898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.253|TWO_SIDED|95.0|-21.1|5.6|||ANCOVA|||||5.6|-21.1|0.253
91698993|NCT02004886|183292898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5||||0.07|TWO_SIDED|95.0|-26.0|1.0|||ANCOVA|||||1.0|-26.0|0.070
91698994|NCT02004886|183292898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-39.5|-12.8|||ANCOVA|||||-12.8|-39.5|<0.001
91698995|NCT02004886|183292899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.9||||0.002|TWO_SIDED|95.0|-145.6|-34.0|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-34.0|-145.6|0.002
91698996|NCT02004886|183292899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-191.1|||<|0.001|TWO_SIDED|95.0|-246.4|-135.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-135.9|-246.4|<0.001
91698997|NCT02004886|183292899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.7||||0.001|TWO_SIDED|95.0|-152.4|-42.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-42.9|-152.4|0.001
91698998|NCT02004886|183292900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.408|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||||3.7|-1.5|0.408
91698999|NCT02004886|183292900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.741|TWO_SIDED|95.0|-3.1|2.2|||ANCOVA|||||2.2|-3.1|0.741
91699000|NCT02004886|183292900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.906|TWO_SIDED|95.0|-2.8|2.5|||ANCOVA|||||2.5|-2.8|0.906
91699001|NCT02004886|183292901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.857|TWO_SIDED|95.0|-30.4|25.3|||ANCOVA|||||25.3|-30.4|0.857
91699002|NCT02004886|183292901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.906|TWO_SIDED|95.0|-30.3|26.9|||ANCOVA|||||26.9|-30.3|0.906
91699003|NCT02004886|183292901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.63|TWO_SIDED|95.0|-34.0|20.8|||ANCOVA|||||20.8|-34.0|0.630
91730450|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.775||||0.138||95.0|0.785|12.87||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||12.870|0.785|0.138
91492041|NCT03000439|182857051|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 48||11.8|-41.8|
91699004|NCT02822573|183292902|SUPERIORITY|Mixed effects repeated measures analysis of covariance (RMANCOVA) models with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification and an unstructured covariance matrix. The primary objective was assessed using a linear contrast of group effect at 24 weeks.||||||0.32|||||||ANCOVA|||With a sample size of 266, there was 90% power to detect a treatment difference of 2 words for HVLT-R total recall score (SD=4.26, effect size=0.47) with a two-sided 5% level of significance. This calculation assumed an ANCOVA model analysis with 25% dropout and 2% missing data at end of treatment. A single interim analysis for futility occurred after 138 participants, with stopping rule of two-sided p-value \< 0.0154. This design required 3.5% more than fixed design, increasing total to 276.||||0.32
91699005|NCT04789291|183292978|OTHER||Ratios of adjusted geometric means [%]|102.76|||||TWO_SIDED|90.0|99.34|106.29|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.8.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.29|99.34|
91699006|NCT04789291|183292979|OTHER||Ratios of adjusted geometric means [%]|77.81|||||TWO_SIDED|90.0|69.77|86.76|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.5.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||86.76|69.77|
91730451|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.342||||0.704||95.0|0.291|6.914||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||6.914|0.291|0.704
91730452|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|0.798||||0.741||95.0|0.194|3.079||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.079|0.194|0.741
91492042|NCT03000439|182857051|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 52||11.8|-41.8|
91492043|NCT03000439|182857054|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 4||5.21|-28.02|
91492044|NCT03000439|182857054|OTHER||Difference in percentage|1.5|||||TWO_SIDED|95.0|-18.37|21.36|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 8||21.36|-18.37|
91492045|NCT03000439|182857054|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 12||23.60|-22.68|
91492046|NCT03000439|182857054|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 16||34.10|-13.82|
91492047|NCT03000439|182857054|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 20||40.92|-8.43|
91492048|NCT03000439|182857054|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 24||34.39|-15.49|
91528468|NCT02572817|182932237|SUPERIORITY||Odds Ratio (OR)|0.86||||0.66|TWO_SIDED|95.0|0.45|1.66|||Regression, Logistic|||||1.66|0.45|0.66
91528469|NCT02572817|182932238|SUPERIORITY||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.5|1.8|||Regression, Logistic|||||1.8|0.5|0.87
91528470|NCT02572817|182932239|SUPERIORITY||Odds Ratio (OR)|1.26||||0.49|TWO_SIDED|95.0|0.65|2.41|||Regression, Logistic|||||2.41|0.65|0.49
91730453|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.292||||0.134||95.0|0.809|7.443||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||7.443|0.809|0.134
91730454|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|3.474||||0.062||95.0|1.039|15.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||15.712|1.039|0.062
91730455|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|6.184||||0.004||95.0|2.025|26.875||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||26.875|2.025|0.004
91492049|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 28||34.33|-16.13|
91492050|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 32||34.33|-16.13|
91492051|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 36||34.33|-16.13|
91528471|NCT02572817|182932240|SUPERIORITY||Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.55|2.08|||Regression, Logistic|||||2.08|0.55|0.83
91699007|NCT04789291|183292980|OTHER||Ratios of adjusted geometric means [%]|103.24|||||TWO_SIDED|90.0|99.73|106.89|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.9.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.89|99.73|
91492052|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 40||34.33|-16.13|
91492053|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 44||34.33|-16.13|
91492054|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 48||37.56|-12.91|
91492055|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 52||37.56|-12.91|
91528472|NCT02572817|182932241|SUPERIORITY||Odds Ratio (OR)|1.29||||0.47|TWO_SIDED|95.0|0.65|2.56|||Regression, Logistic|||||2.56|0.65|0.47
91528473|NCT02572817|182932242|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91528474|NCT02572817|182932243|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Log Rank|||||2.64|0.21|0.64
91492056|NCT03000439|182857054|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 4||5.21|-28.02|
91492057|NCT03000439|182857054|OTHER||Difference in percentage|4.72|||||TWO_SIDED|95.0|-15.72|25.17|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 8||25.17|-15.72|
91492058|NCT03000439|182857054|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 12||23.60|-22.68|
91528475|NCT02572817|182932244|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
91699008|NCT02447497|183292983|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.51|4.1|||Paired t-test|||48 hours post treatment time point. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||4.10|0.51|<0.0001
91492059|NCT03000439|182857054|OTHER||Difference in percentage|13.36|||||TWO_SIDED|95.0|-10.76|37.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 16||37.48|-10.76|
91492060|NCT03000439|182857054|OTHER||Difference in percentage|19.47|||||TWO_SIDED|95.0|-5.2|44.14|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 20||44.14|-5.20|
91492061|NCT03000439|182857054|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 24||34.39|-15.49|
91528476|NCT02572817|182932245|SUPERIORITY||Odds Ratio (OR)|1.33||||0.43|TWO_SIDED|95.0|0.65|2.71|||Regression, Logistic|||Composite mortality and hospitalization, Day 7||2.71|0.65|0.43
91528477|NCT02572817|182932245|SUPERIORITY||Odds Ratio (OR)|1.11||||0.79|TWO_SIDED|95.0|0.5|2.48|||Regression, Logistic|||Composite mortality and hospitalization, Day 14||2.48|0.5|0.79
91528478|NCT02572817|182932245|SUPERIORITY||Odds Ratio (OR)|1.65||||0.29|TWO_SIDED|95.0|0.66|4.12|||Regression, Logistic|||Composite mortality and hospitalization, Day 28||4.12|0.66|0.29
91528479|NCT02572817|182932246|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.2|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||0|-2|0.2
91528480|NCT02572817|182932246|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.66|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||1|-1|0.66
91528481|NCT02572817|182932247|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 3||||0.18
91528482|NCT02572817|182932247|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 7||||0.61
91528483|NCT02572817|182932248|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.68|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.68
91699009|NCT02447497|183292983|SUPERIORITY||Mean Difference (Final Values)|2.37|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|0.6|5.75|||Paired t-test|||48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.75|0.60|0.0001
91699010|NCT02447497|183292983|SUPERIORITY||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.23||0.0001|TWO_SIDED|95.0|0.17|3.75|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||3.75|0.17|0.0001
91699011|NCT02447497|183292983|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.33||0.0001|TWO_SIDED|95.0|0.13|5.04|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.04|0.13|0.0001
91699012|NCT02017912|183292987|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5567||0.7208|TWO_SIDED|95.0|-1.321|0.92|||Mixed Models Analysis|||||0.920|-1.321|0.7208
91699013|NCT02017912|183292988|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.881||0.641|TWO_SIDED|95.0|-2.187|1.36|||Mixed Models Analysis|||||1.360|-2.187|0.6410
91699014|NCT00985959|183293006|SUPERIORITY_OR_OTHER||Overall response rate (%)|69.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|95.0|58.9|79.2||Significance level 5% one-tailed. Threshold response rate 35%|Binominal test|||||79.2|58.9|<0.0001
91699015|NCT02235077|183293043|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5688|TWO_SIDED|95.0|-0.11|0.2|||Regression, Linear|||||0.20|-0.11|0.5688
91699016|NCT02235077|183293044|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4155|TWO_SIDED|95.0|-0.35|0.86|||Regression, Linear|||||0.86|-0.35|0.4155
91699017|NCT02235077|183293045|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3039|TWO_SIDED|95.0|0.83|1.81|||Chi-squared|||||1.81|0.83|0.3039
91699018|NCT02235077|183293046|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.7673|TWO_SIDED|95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.7673
91699019|NCT02235077|183293047|SUPERIORITY||Mean Difference (Final Values)|319.2||||0.5734|TWO_SIDED|95.0|-797.4|1435.8|||Regression, Linear|||||1435.8|-797.4|0.5734
91699020|NCT02235077|183293048|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.3528|TWO_SIDED|95.0|-3.05|1.01|||Regression, Linear|||||1.01|-3.05|0.3528
91699021|NCT02235077|183293049|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0846|TWO_SIDED|95.0|-0.02|0.25|||Regression, Linear|||||0.25|-0.02|0.0846
91730456|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|4.217||||0.028|TWO_SIDED|95.0|1.305|18.806||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||18.806|1.305|0.028
91492062|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 28||34.33|-16.13|
91699022|NCT02235077|183293050|SUPERIORITY||Mean Difference (Final Values)|-12.17||||0.0842|TWO_SIDED|95.0|-25.98|1.65|||Regression, Linear|||||1.65|-25.98|0.0842
91699023|NCT02235077|183293051|SUPERIORITY||Odds Ratio (OR)|1.11||||0.7628|TWO_SIDED|95.0|0.56|2.23|||Regression, Logistic|||||2.23|0.56|0.7628
91699024|NCT02235077|183293052|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.6102|TWO_SIDED|95.0|-5.02|2.95|||Regression, Linear|||||2.95|-5.02|0.6102
91699025|NCT02235077|183293053|SUPERIORITY||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|1.99|||Regression, Logistic|||||1.99|0.29|0.5818
91699026|NCT03852628|183293054|SUPERIORITY||Odds Ratio (OR)|0.17||||0.08|TWO_SIDED|95.0|0.02|1.22|||Mixed Models Analysis|Modeled the probability of having a reduction in AUD||The Placebo arm served as the reference group.||1.22|0.02|0.08
91699027|NCT03852628|183293055|SUPERIORITY||Odds Ratio (OR)|0.76||||0.69|TWO_SIDED|95.0|0.2|2.97|||Mixed Models Analysis|Modeled the probability of reduction in PTSD symptom.||The placebo arm served as the reference group.||2.97|0.20|0.690
91699028|NCT03852628|183293056|SUPERIORITY||Odds Ratio (OR)|0.63||||0.52|TWO_SIDED|95.0|0.15|2.66|||Mixed Models Analysis|Modeled the probability of have both a reduction in PTSD and AUD||The Placebo arm served as the reference group.||2.66|0.15|0.52
91699029|NCT04064411|183293070|NON_INFERIORITY|"Noninferiority margin = 2.0% for abaloparatide-sMTS compared with abaloparatide-SC.~Non-inferiority was to be concluded if the lower bound of the 2-sided 95% confidence interval (CI) for the estimated treatment difference (abaloparatide-sMTS minus abaloparatide-SC) in the percent change from baseline in lumbar spine BMD at 12 months was above -2.0% using a Mixed Model for Repeated Measures (MMRM) analysis."|Least Squares Means (LSM) Difference|-3.721|||||TWO_SIDED|95.0|-5.0089|-2.4331|||||LSM Difference = abaloparatide-sMTS minus abaloparatide-SC|||-2.4331|-5.0089|
91699030|NCT01672710|183293085|SUPERIORITY||Mean Difference (Net)|6.9|||<|0.05|TWO_SIDED|95.0|-0.3|14.2|||ANCOVA|||||14.2|-0.3|<0.05
91699031|NCT05239494|183293093|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.001|TWO_SIDED||||||Shapiro-Wilks|||This study used a ±50 VAS scale, with values in the positive and negative range indicating that the contact lenses were comfortable or uncomfortable, respectively. A score of zero on this scale indicated neutral CL comfort.||||<0.001
91699032|NCT03155178|183293103|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|-0.53|0.07|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.07|-0.53|0.13
91699033|NCT03155178|183293103|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.78|TWO_SIDED|95.0|-0.23|0.3|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.30|-0.23|0.78
91730457|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|3.802||||0.044||95.0|1.157|17.075||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||17.075|1.157|0.044
91730458|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.342||||0.519||95.0|0.551|3.382||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.382|0.551|0.519
91730459|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.961||||0.117||95.0|0.863|4.741||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.741|0.863|0.117
91699034|NCT03155178|183293103|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.77|TWO_SIDED|95.0|-0.38|0.29|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.29|-0.38|0.77
91699035|NCT03155178|183293103|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.15||0.37|TWO_SIDED|95.0|-0.45|0.17|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.17|-0.45|0.37
91699036|NCT03155178|183293103|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.58|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.58|-0.20|0.33
91699037|NCT03155178|183293103|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.65|TWO_SIDED|95.0|-0.25|0.39|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.39|-0.25|0.65
91730460|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.471||||0.393||95.0|0.612|3.687||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.687|0.612|0.393
91730461|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.087||||0.086||95.0|0.923|5.043||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||5.043|0.923|0.086
91492063|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 32||34.33|-16.13|
91730462|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.774||||0.168||95.0|0.798|4.143||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.143|0.798|0.168
91492064|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 36||34.33|-16.13|
91492065|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 40||34.33|-16.13|
91528484|NCT02572817|182932249|SUPERIORITY||Odds Ratio (OR)|1.42||||0.98|TWO_SIDED|95.0|0.23|11.01|||Regression, Logistic|||||11.01|0.23|0.98
91492066|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 44||37.56|-12.91|
91492067|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 48||37.56|-12.91|
91528485|NCT02572817|182932250|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.5||||0.37|TWO_SIDED|95.0|-6.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-6|0.37
91730463|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.374||||0.03||95.0|1.112|5.41||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.410|1.112|0.030
91730464|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.605||||0.287|TWO_SIDED|95.0|0.681|3.971||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.971|0.681|0.287
91730465|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.108||||0.08||95.0|0.936|5.076||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||5.076|0.936|0.080
91730466|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.599||||0.247|TWO_SIDED|95.0|0.73|3.636||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||3.636|0.730|0.247
91492068|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 52||37.56|-12.91|
91730467|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|2.481||||0.017||95.0|1.201|5.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||5.441|1.201|0.017
91699038|NCT03155178|183293104|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.63|0.24|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.24|-0.63|0.38
91699039|NCT03155178|183293104|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.68|TWO_SIDED|95.0|-0.3|0.45|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||0.45|-0.30|0.68
91699040|NCT03155178|183293104|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.97|TWO_SIDED|95.0|-0.47|0.45|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.45|-0.47|0.97
91699041|NCT03155178|183293104|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.23||0.4|TWO_SIDED|95.0|-0.27|0.65|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.65|-0.27|0.40
91699042|NCT03155178|183293104|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.25||0.03|TWO_SIDED|95.0|0.05|1.03||Using a Hochberg Step-up procedure the critical p value is 0.17|Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||1.03|0.05|0.03
91699043|NCT03155178|183293104|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.23||0.07|TWO_SIDED|95.0|-0.03|0.87|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.87|-0.03|0.07
91699044|NCT02195310|183293142|SUPERIORITY|||||||0.7007|||||||Fisher Exact Test (2-sided)|||||||0.7007
91730468|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.728||||0.212||95.0|0.744|4.236||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.236|0.744|0.212
91492069|NCT03000439|182857054|OTHER||Difference in percentage|-13.82|||||TWO_SIDED|95.0|-38.14|10.49|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 4||10.49|-38.14|
91492070|NCT03000439|182857054|OTHER||Difference in percentage|-9.56|||||TWO_SIDED|95.0|-32.28|13.15|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 8||13.15|-32.28|
91730469|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|3.536||||0.002||95.0|1.666|8.207||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||8.207|1.666|0.002
91492071|NCT03000439|182857054|OTHER||Difference in percentage|-0.23|||||TWO_SIDED|95.0|-24.7|24.24|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 12||24.24|-24.70|
91492072|NCT03000439|182857054|OTHER||Difference in percentage|5.88|||||TWO_SIDED|95.0|-19.31|31.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 16||31.06|-19.31|
91492073|NCT03000439|182857054|OTHER||Difference in percentage|19.12|||||TWO_SIDED|95.0|-5.81|44.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 20||44.06|-5.81|
91492074|NCT03000439|182857054|OTHER||Difference in percentage|1.96|||||TWO_SIDED|95.0|-23.55|27.47|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 24||27.47|-23.55|
91730470|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|1.701||||0.225||95.0|0.733|4.169||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.169|0.733|0.225
91730471|NCT04003142|183355932|SUPERIORITY||Odds Ratio (OR)|3.049||||0.006||95.0|1.42|7.125||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||7.125|1.420|0.006
91730472|NCT04806373|183355937|OTHER|||||||0.863|||||||Fisher Exact|||||||0.863
91730473|NCT04806373|183355938|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Difference in pleural drainage volume day 1 post-TSP||||0.005
91528486|NCT02572817|182932251|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
91528487|NCT02572817|182932252|SUPERIORITY||Hodges-Lehman estimate of location shift|-3.0||||0.22|TWO_SIDED|95.0|-14.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-14|0.22
91730474|NCT04806373|183355939|OTHER|||||||0.891|||||||Wilcoxon (Mann-Whitney)|||Borg dyspnea scale day 3 post-TSP||||0.891
91730475|NCT04806373|183355940|OTHER|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Pain score at day 3 post-TSP||||0.899
91730476|NCT04806373|183355941|OTHER|||||||0.809|||||||Fisher Exact|||||||0.809
91730477|NCT04806373|183355942|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
91699045|NCT00834639|183293150|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|97.36||||||90.0|93.68|101.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.18|93.68|
91699046|NCT00834639|183293151|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.59||||||90.0|97.07|104.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.24|97.07|
91699047|NCT00834639|183293152|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.36||||||90.0|97.35|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.46|97.35|
91699048|NCT05010512|183293163|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with terms for lens, period and sequence as fixed effects, subject as a random effect. Difference = DT1 minus Infuse|||0.01||
91699049|NCT00805870|183293175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.271|STANDARD_ERROR_OF_MEAN|26.298|>|0.05|TWO_SIDED|95.0|-63.521|46.978|||ANOVA|||Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.||46.978|-63.521|>0.05
91492075|NCT03000439|182857054|OTHER|The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|Difference in percentage|15.21|||||TWO_SIDED|95.0|-10.05|40.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 28||40.46|-10.05|
91492076|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 32||37.56|-12.91|
91492077|NCT03000439|182857054|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 36||34.33|-16.13|
91699050|NCT00805870|183293176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.845|STANDARD_ERROR_OF_MEAN|1.417|>|0.05|TWO_SIDED|95.0|-4.823|1.132|||ANOVA|||Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.||1.132|-4.823|>0.05
91730478|NCT04806373|183355943|OTHER|||||||0.808|||||||Wilcoxon (Mann-Whitney)|||||||0.808
91492078|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 40||37.56|-12.91|
91492079|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 44||37.56|-12.91|
91492080|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 48||37.56|-12.91|
91492081|NCT03000439|182857054|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 52||37.56|-12.91|
91528488|NCT02572817|182932253|SUPERIORITY||Odds Ratio (OR)|0.74||||1|TWO_SIDED|95.0|0.08|9.29|||Regression, Logistic|||||9.29|0.08|1
91528489|NCT02572817|182932255|SUPERIORITY||Odds Ratio (OR)|0.33||||0.24|TWO_SIDED|95.0|0.05|1.79|||Regression, Logistic|||||1.79|0.05|0.24
91699051|NCT00805870|183293177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.015|STANDARD_ERROR_OF_MEAN|47.093|>|0.05|TWO_SIDED|95.0|-156.373|42.344|||ANOVA|||Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.||42.344|-156.373|>0.05
91699052|NCT00805870|183293178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.188|>|0.05|TWO_SIDED|95.0|-0.374|0.417|||ANOVA|||The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.||0.417|-0.374|>0.05
91730479|NCT04806373|183355944|OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
91730480|NCT04806373|183355945|OTHER|||||||0.714|||||||t-test, 2 sided|||||||0.714
91492082|NCT03000439|182857054|OTHER||Difference in percentage|-19.82|||||TWO_SIDED|95.0|-44.09|4.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 4||4.46|-44.09|
91492083|NCT03000439|182857054|OTHER||Difference in percentage|-17.28|||||TWO_SIDED|95.0|-40.19|5.63|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 8||5.63|-40.19|
91492084|NCT03000439|182857054|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 20||14.45|-29.66|
91492085|NCT03000439|182857054|OTHER||Difference in percentage|-13.71|||||TWO_SIDED|95.0|-37.19|9.77|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 12||9.77|-37.19|
91730481|NCT04806373|183355946|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91730482|NCT03382873|183355947|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91730483|NCT03382873|183355948|SUPERIORITY|||||||0.0001|||||||ANOVA|Intervention sequence and sex were used as independent predictors in the model.||Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.0001
91699053|NCT00380081|183293212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91699054|NCT00380081|183293213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.001
91730484|NCT03382873|183355949|SUPERIORITY|||||||0.9476|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9476
91492086|NCT03000439|182857054|OTHER||Difference in percentage|-4.03|||||TWO_SIDED|95.0|-26.67|18.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 16||18.61|-26.67|
91492087|NCT03000439|182857054|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 32||5.83|-35.32|
91492088|NCT03000439|182857054|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 24||17.26|-26.02|
91492089|NCT03000439|182857054|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 28||12.99|-28.89|
91492090|NCT03000439|182857054|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 36||16.83|-30.65|
91492091|NCT03000439|182857054|OTHER||Difference in percentage|-3.69|||||TWO_SIDED|95.0|-27.16|19.78|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 40||19.78|-27.16|
91492092|NCT03000439|182857054|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 44||22.68|-23.60|
91699055|NCT00380081|183293214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91492093|NCT03000439|182857054|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 48||22.68|-23.60|
91492094|NCT03000439|182857054|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 52||22.68|-23.60|
91492095|NCT03000439|182857054|OTHER||Difference in percentage|-21.2|||||TWO_SIDED|95.0|-42.45|0.05|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 4||0.05|-42.45|
91492096|NCT03000439|182857054|OTHER||Difference in percentage|-18.32|||||TWO_SIDED|95.0|-37.98|1.34|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 8||1.34|-37.98|
91528490|NCT02572817|182932257|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91699056|NCT00380081|183293215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91699057|NCT00380081|183293216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91492097|NCT03000439|182857054|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 12||8.61|-31.65|
91492098|NCT03000439|182857054|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 16||12.99|-28.89|
91492099|NCT03000439|182857054|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 20||18.91|-16.15|
91492100|NCT03000439|182857054|OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-21.36|18.37|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 24||18.37|-21.36|
91492101|NCT03000439|182857054|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 28||11.32|-27.91|
91492102|NCT03000439|182857054|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 32||4.10|-34.29|
91492103|NCT03000439|182857054|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 36||8.61|-31.65|
91699058|NCT00380081|183293217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91699059|NCT00380081|183293218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.||||<0.001
91699060|NCT00380081|183293219|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.004
91699061|NCT00380081|183293220|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||0.012
91699062|NCT00380081|183293221|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91730485|NCT03382873|183355950|SUPERIORITY|||||||0.0112|||||||ANOVA|Treatment group, time and their interaction were fixed effects and participants were random effects||||||0.0112
91730486|NCT03382873|183355951|SUPERIORITY|||||||0.9085|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9085
91699063|NCT00380081|183293222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
91699064|NCT00380081|183293223|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||Treatment effect|ANCOVA|||||||0.790
91699065|NCT00380081|183293224|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||Treatment effect|ANCOVA|||||||0.083
91699066|NCT00380081|183293225|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Treatment effect|ANCOVA|||||||0.072
91699067|NCT00380081|183293225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Period effect|ANCOVA|||||||<0.001
91699068|NCT00380081|183293226|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Treatment effect|ANCOVA|||||||0.017
91699069|NCT02231879|183293228|SUPERIORITY|This is a two-sided test, with the null hypothesis that the distribution of the difference scores is the same in both arms.||||||0.65||||||Not adjusted for multiple comparisons, since this is the only pre-specified primary analysis. P\<=0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||This was a pre-specified primary analysis plan, and the two arms are compared with a Wilcoxon-Mann-Whitney test on the primary outcome. This is non-standard (since both arms contain both treatment groups), however, it is a valid test by randomization since it is a permutation test. The statistic of TISS in Period 1 minus TISS in Period 2 was chosen so that even if there are carry-over effects this will give a valid test.||||0.65
91730487|NCT03382873|183355952|SUPERIORITY|||||||0.2063|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison between the GLB/GLB intervention sequence and the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.2063
91730488|NCT02470377|183355957|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0439||||||Only p-values \<0.05 were considered significant|ANOVA|One way ANOVA, immediate DHI changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0439
91492104|NCT03000439|182857054|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 40||14.45|-29.66|
91492105|NCT03000439|182857054|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 44||17.26|-26.02|
91492106|NCT03000439|182857054|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 48||21.43|-23.04|
91492107|NCT03000439|182857054|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 52||21.43|-23.04|
91492108|NCT03000439|182857062|OTHER||Difference in percentage|-7.83|||||TWO_SIDED|95.0|-23.42|7.75|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.75|-23.42|
91528491|NCT02572817|182932258|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.06|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 3||0|-1|0.06
91699070|NCT02231879|183293228|SUPERIORITY||||||<|0.0001||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute lymphocyte count greater than 1000 cells/microliter measured 3 hours after a dose for plerixafor as compared to G-CSF||||<0.0001
91699071|NCT02231879|183293228|NON_INFERIORITY|Pre-specified non-inferiority margin of 0.40 which was estimated to be about 50% of the effect size of G-CSF versus placebo.||||||0.023||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute neutrophil counts \>500 cells/microliter for G-CSF versus plerixafor measured as the proportion of successes (75% of measured) while on G-CSF minus the proportion on plerixafor||||0.023
91699072|NCT00459706|183293231|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95 percent (%) two-sided confidence interval (CI) of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.71|1.5|||ANOVA|ANOVA=analysis of variance||Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (\>) -1.||1.50|0.71|<0.001
91699073|NCT00459706|183293232|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95% two-sided CI of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.85|1.64|||ANOVA|||"Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI - PFS ≤ -1 H1: AI - PFS \> -1"||1.64|0.85|<0.001
91699074|NCT00459706|183293233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.058|TWO_SIDED|95.0|0.98|3.05|||GEE Model+Logit Link+Binomial Distributn|GEE=Generalized estimating equation Distribn=distribution||||3.05|0.98|0.058
91699075|NCT00459706|183293234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.019|TWO_SIDED|95.0|1.12|3.43|||GEE Model+Logit Link+Binomial Distributn|||||3.43|1.12|0.019
91492109|NCT03000439|182857062|OTHER||Difference in percentage|5.07|||||TWO_SIDED|95.0|-13.94|24.08|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||24.08|-13.94|
91730489|NCT02470377|183355958|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0316|||||||ANOVA|One way ANOVA, immediate MBRS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0316
91699076|NCT00459706|183293235|SUPERIORITY_OR_OTHER||Regression coefficient|0.11||||0.16|TWO_SIDED|95.0|-0.04|0.27|||Regression, Linear|||All categories||0.27|-0.04|0.160
91699077|NCT00459706|183293236|SUPERIORITY_OR_OTHER||Regression coefficients|-0.75||||0.001|TWO_SIDED|95.0|-1.2|-0.29|||Regression, Linear|||Female versus male (reference).||-0.29|-1.20|0.001
91699078|NCT00459706|183293237|SUPERIORITY_OR_OTHER||Regression coefficient|-0.18||||0.676|TWO_SIDED|95.0|-0.62|0.26|||Regression, Linear|||Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).||0.26|-0.62|0.676
91699079|NCT00459706|183293237|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.676|TWO_SIDED|95.0|-0.59|0.6|||Regression, Linear|||Participants at University Level versus participants with only Reading/Writing Capacity (reference).||0.60|-0.59|0.676
91699080|NCT00459706|183293238|SUPERIORITY_OR_OTHER||Regression coefficient|-0.28||||0.02|TWO_SIDED|95.0|-0.52|-0.05|||Regression, Linear|||All categories||-0.05|-0.52|0.020
91699081|NCT00459706|183293239|SUPERIORITY_OR_OTHER||Regression coefficient|-0.35||||0.008|TWO_SIDED|95.0|-0.61|-0.09|||Regression, Linear|||All categories||-0.09|-0.61|0.008
91699082|NCT00459706|183293240|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.03|TWO_SIDED|95.0|0.02|0.32|||Regression, Linear|||All categories||0.32|0.02|0.030
91730490|NCT02470377|183355959|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.1754|||||||ANOVA|One way ANOVA, immediate HADS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.1754
91730491|NCT02539394|183355971|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.394|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms||||0.394
91492110|NCT03000439|182857062|OTHER||Difference in percentage|0.81|||||TWO_SIDED|95.0|-21.43|23.04|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.04|-21.43|
91699083|NCT00459706|183293241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.6||||0.006|TWO_SIDED|95.0|-1.03|-0.18|||Regression, Linear|||Self-injection Experience versus No Self-injection Experience (reference).||-0.18|-1.03|0.006
91699084|NCT00459706|183293242|SUPERIORITY_OR_OTHER||Regression coefficient|0.06||||0.278|TWO_SIDED|95.0|-0.05|0.18|||Regression, Linear|||All categories||0.18|-0.05|0.278
91492111|NCT03000439|182857062|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||34.10|-13.82|
91699085|NCT00459706|183293243|SUPERIORITY_OR_OTHER||Regression coefficient|0.03||||0.749|TWO_SIDED|95.0|-0.15|0.21|||Regression, Linear|||All categories||0.21|-0.15|0.749
91699086|NCT00459706|183293244|SUPERIORITY_OR_OTHER||Regression coefficient|-0.08||||0.105|TWO_SIDED|95.0|-0.18|0.02|||Regression, Linear|||All categories||0.02|-0.18|0.105
91699087|NCT00459706|183293245|SUPERIORITY_OR_OTHER||Regression coefficient|0.01||||0.819|TWO_SIDED|95.0|-0.1|0.12|||Regression, Linear|||All categories||0.12|-0.10|0.819
91699088|NCT00459706|183293246|SUPERIORITY_OR_OTHER||Regression coefficient|-0.39||||0.012|TWO_SIDED|95.0|-0.69|-0.09|||Regression, Linear|||All categories, by 1-unit increments.||-0.09|-0.69|0.012
91699089|NCT00459706|183293247|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1||||0.541|TWO_SIDED|95.0|-0.52|0.32|||Regression, Linear|||2 DMARDs versus 1 DMARD (reference).||0.32|-0.52|0.541
91699090|NCT00459706|183293247|SUPERIORITY_OR_OTHER||Regression coefficient|-0.14||||0.541|TWO_SIDED|95.0|-0.97|0.68|||Regression, Linear|||3 DMARDs versus 1 DMARD (reference).||0.68|-0.97|0.541
91699091|NCT00459706|183293247|SUPERIORITY_OR_OTHER||Regression coefficient|1.72||||0.541|TWO_SIDED|95.0|-0.82|4.25|||Regression, Linear|||At least 4 DMARDs versus 1 DMARD (reference).||4.25|-0.82|0.541
91699092|NCT00459706|183293248|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.465|TWO_SIDED|95.0|-0.55|0.25|||Regression, Linear|||Prior Injection Experience versus No Prior Injection Experience (reference)||0.25|-0.55|0.465
91699093|NCT00459706|183293249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.29||0.154|TWO_SIDED|95.0|-0.97|0.15|||ANOVA|||||0.15|-0.97|0.154
91699094|NCT00459706|183293250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.17||0.212|TWO_SIDED|95.0|-0.12|0.56|||ANOVA|||||0.56|-0.12|0.212
91699095|NCT00459706|183293251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.19||0.965|TWO_SIDED|95.0|-0.39|0.37|||ANOVA|||||0.37|-0.39|0.965
91699096|NCT00459706|183293252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.19||0.519|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||||0.50|-0.25|0.519
91699097|NCT00459706|183293253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.33|2.57|||GEE model+logit link+multinomial distrib|||Day 84||2.57|1.33|<0.001
91699098|NCT00459706|183293254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.007|TWO_SIDED|95.0|1.14|2.29|||GEE model+logit link+multinomial distrib|||||2.29|1.14|0.007
91699099|NCT00459706|183293255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.26|2.92|||GEE model+logit link+multinomial distrib|||||2.92|1.26|0.002
91730492|NCT02539394|183355971|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.017|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms||||0.017
91730493|NCT02539394|183355971|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.015|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Burden is the same across the 2 arms||||0.015
91730494|NCT02539394|183355971|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.125|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 arms||||0.125
91699100|NCT00459706|183293256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.65|3.46|||GEE model+logit link+multinomial distrib|||||3.46|1.65|<0.001
91699101|NCT00459706|183293257|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001|TWO_SIDED|95.0|1.5|2.83|||GEE model+logit link+multinomial distrib|||||2.83|1.50|<0.001
91699102|NCT00459706|183293258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.44|2.78|||GEE model+logit link+multinomial distrib|||||2.78|1.44|<0.001
91699103|NCT00459706|183293259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.184|TWO_SIDED|95.0|0.9|1.72|||GEE model+logit link+multinomial distrib|||||1.72|0.90|0.184
91699104|NCT00459706|183293260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.106|TWO_SIDED|95.0|0.94|1.85|||GEE model+logit link+multinomial distrib|||||1.85|0.94|0.106
91699105|NCT00459706|183293261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.112|TWO_SIDED|95.0|0.93|1.96|||GEE model+logit link+multinomial distrib|||||1.96|0.93|0.112
91699106|NCT00459706|183293262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.24|||GEE model+logit link+multinomial distrib|||||2.24|1.21|0.002
91699107|NCT00459706|183293263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57|||<|0.001|TWO_SIDED|95.0|0.41|0.78|||GEE model+logit link+multinomial distrib|||||0.78|0.41|<0.001
91492112|NCT03000439|182857062|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||40.92|-8.43|
91492113|NCT03000439|182857062|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||34.39|-15.49|
91492114|NCT03000439|182857062|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||34.33|-16.13|
91699108|NCT00459706|183293264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.022|TWO_SIDED|95.0|0.47|0.94|||GEE model+logit link+multinomial distrib|||||0.94|0.47|0.022
91699109|NCT00459706|183293265|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.009|TWO_SIDED|95.0|0.46|0.89|||GEE model+logit link+multinomial distrib|||||0.89|0.46|0.009
91699110|NCT00459706|183293266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.007|TWO_SIDED|95.0|0.45|0.88|||GEE model+logit link+multinomial distrib|||||0.88|0.45|0.007
91699111|NCT00459706|183293267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.014|TWO_SIDED|95.0|0.47|0.92|||GEE model+logit link+multinomial distrib|||||0.92|0.47|0.014
91699112|NCT00459706|183293268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.88|||GEE model+logit link+multinomial distrib|||||2.88|1.53|<0.001
91699113|NCT00459706|183293269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.57|2.91|||GEE model+logit link+multinomial distrib|||||2.91|1.57|<0.001
91699114|NCT00459706|183293270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|2.23|4.25|||GEE model+logit link+multinomial distrib|||||4.25|2.23|<0.001
91699115|NCT00459706|183293271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.35|2.62|||GEE model+logit link+multinomial distrib|||||2.62|1.35|<0.001
91699116|NCT00459706|183293272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.34|||GEE model+logit link+multinomial distrib|||||0.34|0.18|<0.001
91699117|NCT00459706|183293273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.19|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.19|<0.001
91492115|NCT03000439|182857062|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||34.33|-16.13|
91492116|NCT03000439|182857062|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||34.33|-16.13|
91492117|NCT03000439|182857062|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.33|-16.13|
91699118|NCT00459706|183293274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.2|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.20|<0.001
91699119|NCT00459706|183293275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.196|TWO_SIDED|95.0|0.61|1.11|||GEE model+logit link+multinomial distrib|||||1.11|0.61|0.196
91699120|NCT00459706|183293276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.001|TWO_SIDED|95.0|1.25|2.42|||GEE model+logit link+multinomial distrib|||||2.42|1.25|0.001
91699121|NCT00459706|183293277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.42|||GEE model+logit link+multinomial distrib|||||0.42|0.21|<0.001
91699122|NCT00459706|183293278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.29|0.56|||GEE model+logit link+multinomial distrib|||||0.56|0.29|<0.001
91699123|NCT00459706|183293279|SUPERIORITY_OR_OTHER|||||||0.896|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.896
91699124|NCT00459706|183293279|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.166
91699125|NCT00459706|183293280|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
91699126|NCT00459706|183293280|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
91699127|NCT00459706|183293281|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
91699128|NCT00459706|183293281|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
91699129|NCT00459706|183293282|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
91699130|NCT00459706|183293282|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
91699131|NCT00459706|183293283|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
91492118|NCT03000439|182857062|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||34.33|-16.13|
91492119|NCT03000439|182857062|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||37.56|-12.91|
91492120|NCT03000439|182857062|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||37.56|-12.91|
91492121|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-2.4|2.38||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.38|-2.40|
91492122|NCT03000439|182857068|OTHER||Difference in LS Mean|0.94|||||TWO_SIDED|95.0|-2.25|4.12||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.12|-2.25|
91492123|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-4.54|4.06||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.06|-4.54|
91492124|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.86|||||TWO_SIDED|95.0|-3.99|2.28||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.28|-3.99|
91492125|NCT03000439|182857068|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-3.12|0.94||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-3.12|
91492126|NCT03000439|182857068|OTHER||Difference in LS Mean|0.3|||||TWO_SIDED|95.0|-1.46|2.06||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.06|-1.46|
91492127|NCT03000439|182857068|OTHER||Difference in LS Mean|-1.28|||||TWO_SIDED|95.0|-7.85|5.29||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.29|-7.85|
91492128|NCT03000439|182857068|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-1.98|2.93||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-1.98|
91492129|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.86|1.35||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.35|-1.86|
91492130|NCT03000439|182857068|OTHER||Difference in LS Mean|0.73|||||TWO_SIDED|95.0|-2.18|3.63||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.63|-2.18|
91730495|NCT02539394|183355972|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.043|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 arms||||0.043
91492131|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.83|||||TWO_SIDED|95.0|-3.22|1.56||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.56|-3.22|
91492132|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.23|||||TWO_SIDED|95.0|-1.76|1.3||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.76|
91492133|NCT03000439|182857068|OTHER||Difference in LS Mean|-0.75|||||TWO_SIDED|95.0|-3.43|1.93||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.93|-3.43|
91492134|NCT03000439|182857069|OTHER||Difference in LS Mean|0.9|||||TWO_SIDED|95.0|-1.8|3.61||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.61|-1.80|
91492135|NCT03000439|182857069|OTHER||Difference in LS Mean|2.11|||||TWO_SIDED|95.0|-0.64|4.86||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.86|-0.64|
91492136|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-4.25|4.21||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.21|-4.25|
91492137|NCT03000439|182857069|OTHER||Difference in LS Mean|-1.12|||||TWO_SIDED|95.0|-4.32|2.09||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.09|-4.32|
91492138|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.53|||||TWO_SIDED|95.0|-3.04|1.98||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.98|-3.04|
91730496|NCT02539394|183355972|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.606|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 arms||||0.606
91730497|NCT02539394|183355972|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.155|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 arms||||0.155
91699132|NCT00459706|183293283|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
91699133|NCT00459706|183293284|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
91492139|NCT03000439|182857069|OTHER||Difference in LS Mean|1.84|||||TWO_SIDED|95.0|-1.29|4.97||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.97|-1.29|
91492140|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-5.89|5.72||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.72|-5.89|
91492141|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.69|||||TWO_SIDED|95.0|-3.79|2.41||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.41|-3.79|
91492142|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.35|||||TWO_SIDED|95.0|-1.89|1.19||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-1.89|
91492143|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-3.63|3.58||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.58|-3.63|
91492144|NCT03000439|182857069|OTHER||Difference in LS Mean|-2.59|||||TWO_SIDED|95.0|-5.67|0.49||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-5.67|
91492145|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.82|||||TWO_SIDED|95.0|-2.82|1.19||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-2.82|
91492146|NCT03000439|182857069|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-3.27|2.36||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.36|-3.27|
91699134|NCT00459706|183293284|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
91699135|NCT00459706|183293285|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.023
91492147|NCT03000439|182857082|OTHER||Difference in LS Mean|0.86|||||TWO_SIDED|95.0|-0.08|1.79||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.79|-0.08|
91492148|NCT03000439|182857082|OTHER||Difference in LS Mean|1.32|||||TWO_SIDED|95.0|0.25|2.4||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.40|0.25|
91699136|NCT00459706|183293285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
91699137|NCT00459706|183293286|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.038
91699138|NCT00459706|183293286|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
91492149|NCT03000439|182857082|OTHER||Difference in LS Mean|1.43|||||TWO_SIDED|95.0|-0.79|3.66||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||3.66|-0.79|
91492150|NCT03000439|182857082|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.7|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.74|-0.70|
91492151|NCT03000439|182857082|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.43|0.64||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.64|-0.43|
91492152|NCT03000439|182857082|OTHER||Difference in LS Mean|0.44|||||TWO_SIDED|95.0|0.06|0.81||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.81|0.06|
91492153|NCT03000439|182857082|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.64|2.06||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.06|-1.64|
91492154|NCT03000439|182857082|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.04|1.03||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.03|-0.04|
91699139|NCT00459706|183293287|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.018
91699140|NCT00459706|183293287|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.019
91699141|NCT00459706|183293288|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.049
91699142|NCT00459706|183293288|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.736
91699143|NCT00459706|183293289|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.033
91699144|NCT00459706|183293289|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.730
91528492|NCT02572817|182932258|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.13|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 7||0|-1|0.13
91699145|NCT00459706|183293290|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.838
91492155|NCT03000439|182857082|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.09|0.79||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.79|-0.09|
91492156|NCT03000439|182857082|OTHER||Difference in LS Mean|0.52|||||TWO_SIDED|95.0|-0.23|1.28||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.28|-0.23|
91492157|NCT03000439|182857082|OTHER||Difference in LS Mean|-0.19|||||TWO_SIDED|95.0|-1.2|0.83||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.83|-1.20|
91492158|NCT03000439|182857082|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.49|0.91||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.91|-0.49|
91492159|NCT03000439|182857082|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.8|0.92||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.92|-0.80|
91492160|NCT03000439|182857083|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.43|1.0||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.00|-0.43|
91528493|NCT02572817|182932259|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 3||||0.36
91528494|NCT02572817|182932259|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 7||||0.15
91492161|NCT03000439|182857083|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|-0.06|2.08||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-0.06|
91492162|NCT03000439|182857083|OTHER||Difference in LS Mean|1.25|||||TWO_SIDED|95.0|-1.13|3.64||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.64|-1.13|
91528495|NCT02572817|182932260|SUPERIORITY||Odds Ratio (OR)|1.73||||0.12|TWO_SIDED|95.0|0.87|3.44|||Regression, Logistic|||||3.44|0.87|0.12
91528496|NCT02572817|182932261|SUPERIORITY||Odds Ratio (OR)|0.47||||0.23|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||||1.43|0.13|0.23
91528497|NCT02340520|182932314|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91699146|NCT00459706|183293290|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.483
91699147|NCT00459706|183293291|SUPERIORITY_OR_OTHER|||||||0.466||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.466
91492163|NCT03000439|182857083|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.68|0.88||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-0.68|
91492164|NCT03000439|182857083|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.58|0.33||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.58|
91492165|NCT03000439|182857083|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.03|0.68||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.68|-0.03|
91492166|NCT03000439|182857083|OTHER||Difference in LS Mean|-0.17|||||TWO_SIDED|95.0|-2.42|2.08||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-2.42|
91492167|NCT03000439|182857083|OTHER||Difference in LS Mean|0.42|||||TWO_SIDED|95.0|-0.14|0.97||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.97|-0.14|
91528498|NCT02340520|182932315|OTHER||||||>|0.1|||||||ANOVA|||||||>0.1
91528499|NCT01586338|182932317|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance = 0.05.|Paired t-test|||||||<0.0001
91528500|NCT01586338|182932317|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign Rank Test|||||||<0.0001
91528501|NCT00930943|182932383|SUPERIORITY||||||<|0.001||||||repeated-measure ANOVA tested time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||The a priori sample-size estimation for a power of 80% with alpha = 0.05 was based on the primary-outcome measure, the rapid visual information processing (RVP) sensitivity (A') score. Using a repeated-measure ANOVA for the food effect (fed versus fasting) and assuming an effect size of f =0.26 generated a required sample size of 32 participants. However, only 30 subjects completed both testing visits, generating a power of 78.2%.|(F\[1,28\] = 22.71; η2 = 0.45)|||<0.001
91528502|NCT00930943|182932383|SUPERIORITY|||||||0.01||||||repeated-measure ANOVA tested food x time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA||||F\[1,28\]=6.88; η2=0.20|||0.01
91528503|NCT00930943|182932383|SUPERIORITY||||||>|0.05||||||repeated-measure ANOVA testing food effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||||||>0.05
91699148|NCT00459706|183293291|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.035
91699149|NCT00459706|183293292|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.784
91699150|NCT00459706|183293292|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.006
91699151|NCT00459706|183293293|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.843
91699152|NCT00459706|183293293|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.461
91699153|NCT00459706|183293294|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.150
91699154|NCT00459706|183293294|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.002
91699155|NCT00459706|183293295|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
91699156|NCT00459706|183293295|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
91730498|NCT02539394|183355972|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 arms||||0.019
91730499|NCT02539394|183355973|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.25|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 arms||||0.250
91528504|NCT00930943|182932384|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Rapid Visual Information Processing (RVP): response latency|ANOVA||||(F\[1,28\] = 14.05; η2 = 0.33)|||<0.001
91528505|NCT00930943|182932384|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time post dose effect for Rapid Visual Information Processing (RVP): response latency"|ANOVA|||||||>0.05
91699157|NCT00459706|183293296|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
91699158|NCT00459706|183293296|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
91699159|NCT00459706|183293297|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
91492168|NCT03000439|182857083|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.15|0.79||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.79|-0.15|
91699160|NCT00459706|183293297|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
91699161|NCT00459706|183293298|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||<0.001
91699162|NCT00459706|183293298|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
91699163|NCT01322035|183293315|EQUIVALENCE|95% confidence limits from standard deviation of the mean were used as the equivalence.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|95% confidence limits from standard deviation||||||<0.05
91699164|NCT00535847|183293323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.703|||||TWO_SIDED|95.0|4.259|37.884||||||Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.||37.884|4.259|
91705511|NCT00497770|183305541|NON_INFERIORITY_OR_EQUIVALENCE|A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was \<1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%.|Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.427|1.58||Adjusted:baseline characteristics, income, marital/insurance status, comorbid, time between end of 1st line therapy and start of pemetrexed, prior platinum- or Paclitaxel-containing regimen, number of cycles and best response during 1st line therapy.|Regression, Logistic|||||1.580|0.427|
91730500|NCT02539394|183355973|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.478|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 arms||||0.478
91730501|NCT02539394|183355973|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 arms||||0.019
91730502|NCT02539394|183355973|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 arms||||0.049
91699165|NCT00715728|183293343|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.||||||0.91||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|"Two 1-tailed tests were conducted to assess equivalence. See  Type of Statistical Test."||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||0.91
91699166|NCT00715728|183293343|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.001||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||<0.001
91699167|NCT00715728|183293344|NON_INFERIORITY|The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C.|Mean Difference (Final Values)|-0.12||||0.018|TWO_SIDED|95.0|-0.37|0.14||P-value was adjusted for preoperative oral temperature and ASA physical status.|t-test, 1 sided||Non-inferiority will be established, at the 0.025 significance level, if the lower limit of a 95% confidence interval for the difference is above -0.5 °C.|Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.||0.14|-0.37|0.018
91699168|NCT01820572|183293366|SUPERIORITY|difference between belatacept and CNI|Difference in proportions|0.9|||||TWO_SIDED|95.0|-8.6|10.4||||||||10.4|-8.6|
91699169|NCT01820572|183293367|SUPERIORITY|difference between belatacept and CNI|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-9.9|9.0||||||||9.0|-9.9|
91730503|NCT02539394|183355974|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.376|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 arms||||0.376
91492169|NCT03000439|182857083|OTHER||Difference in LS Mean|0.68|||||TWO_SIDED|95.0|-0.14|1.49||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.49|-0.14|
91528506|NCT00930943|182932385|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SRM percentage of correct hits"|ANOVA|||||||>0.05
91699170|NCT02105246|183293388|EQUIVALENCE|This analysis compared the proportion of eligible patients who participated in cardiac rehab after referral to home-based vs. referral to center-based programs.|Risk Ratio (RR)|0.98||||0.8|TWO_SIDED||||||Chi-squared|||Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programs||||0.80
91699171|NCT02105246|183293389|NON_INFERIORITY|This analysis compared Baseline to 3-month change in 6-minute walk test distance among subjects who participated in home-based cardiac rehab vs. subjects who participated in center-based cardiac rehab|Median Difference (Final Values)|196.0|||<|0.001|TWO_SIDED|||||This comparison was unadjusted.|Wilcoxon (Mann-Whitney)|||Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||<0.001
91699172|NCT02105246|183293390|NON_INFERIORITY|This analysis compared 6-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab.|Median Difference (Final Values)|159.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||0.03
91699173|NCT00387010|183293391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.3223|TWO_SIDED|95.0|-4.64|1.54|||t-test, 2 sided|||||1.54|-4.64|0.3223
91699174|NCT05356533|183293409|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
91492170|NCT03000439|182857083|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-1.28|0.96||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.96|-1.28|
91528507|NCT00930943|182932386|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Spatial Recognition Memory (SRM) response latency|ANOVA||||(F\[1,28\] = 31.26; η2 = 0.53)|||<0.001
91699175|NCT05356533|183293409|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
91730504|NCT02539394|183355974|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.013|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 arms||||0.013
91730505|NCT02539394|183355974|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 arms||||0.049
91730506|NCT02539394|183355974|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.3|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 arms||||0.300
91492171|NCT03000439|182857083|OTHER||Difference in LS Mean|0.37|||||TWO_SIDED|95.0|-0.43|1.16||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.43|
91528508|NCT00930943|182932386|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time-post-dose effect for SRM response latency"|ANOVA|||||||>0.05
91528509|NCT00930943|182932387|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM total errors"|ANOVA|||||||>0.05
91699176|NCT05356533|183293410|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
91699177|NCT05356533|183293411|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
91699178|NCT05356533|183293412|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
91699179|NCT05356533|183293413|SUPERIORITY||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
91699180|NCT05356533|183293414|SUPERIORITY||Risk Ratio (RR)|1.11|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
91699181|NCT01167881|183293418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|97.5|-4.87|-4.05||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.05|-4.87|<0.0001
91699182|NCT01167881|183293419|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.2|-0.01|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|<0.0001
91699183|NCT01167881|183293419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.0153|TWO_SIDED|97.5|-0.2|-0.01||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|0.0153
91699184|NCT01167881|183293420|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.102|||<|0.0001|TWO_SIDED|97.5|0.06|0.173||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||0.173|0.060|<0.0001
91699185|NCT01167881|183293421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.0|-4.2||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.2|-7.0|<0.0001
91699186|NCT01167881|183293422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.5|-1.8||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-1.8|-3.5|<0.0001
91492172|NCT03000439|182857083|OTHER||Difference in LS Mean|0.24|||||TWO_SIDED|95.0|-0.82|1.3||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.82|
91492173|NCT03000439|182857084|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.07|0.5||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.50|-0.07|
91528510|NCT00930943|182932388|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM strategy score"|ANOVA|||||||>0.05
91730507|NCT02539394|183355975|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.037|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 arms||||0.037
91492174|NCT03000439|182857084|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.15|0.32||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.32|-0.15|
91699187|NCT01167881|183293423|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.16|0.02|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.02|-0.16|<0.0001
91699188|NCT01167881|183293424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|97.5|-5.16|-4.46||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.46|-5.16|<0.0001
91699189|NCT01167881|183293425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.077|||<|0.0001|TWO_SIDED|97.5|0.04|0.148||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.148|0.040|<0.0001
91699190|NCT01167881|183293426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.3|-4.4||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.4|-7.3|<0.0001
91699191|NCT01167881|183293427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.7|-2.0||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-2.0|-3.7|<0.0001
91730508|NCT02539394|183355975|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.858|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Communication is the same across the 2 arms||||0.858
91730509|NCT02539394|183355975|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Communication is the same across the 2 arms||||0.042
91730510|NCT02539394|183355975|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.031|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 arms||||0.031
91730511|NCT02539394|183355976|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.343|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 arms||||0.343
91730512|NCT02539394|183355976|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.022|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.022
91730513|NCT02539394|183355976|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.018|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.018
91492175|NCT03000439|182857084|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.17|0.28||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.28|-0.17|
91492176|NCT03000439|182857084|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.16|0.36||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.16|
91492177|NCT03000439|182857084|OTHER||Difference in LS Mean|0.19|||||TWO_SIDED|95.0|-0.01|0.38||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.01|
91492178|NCT03000439|182857084|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.12|0.35||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.35|-0.12|
91730514|NCT02539394|183355976|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.008|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 arms||||0.008
91492179|NCT03000439|182857084|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.18|0.31||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.31|-0.18|
91492180|NCT03000439|182857084|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.06|0.37||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.37|-0.06|
91492181|NCT03000439|182857084|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.14|0.36||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.14|
91492182|NCT03000439|182857084|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.06|0.38||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.06|
91492183|NCT03000439|182857084|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.30|-0.22|
91492184|NCT03000439|182857084|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.20|
91492185|NCT03000439|182857084|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.24|0.42||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.42|-0.24|
91528511|NCT00856661|182932389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.229|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if alive, or 6, if otherwise = death||All patients who were treated and had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included.||2.64|0.79|0.2290
91528512|NCT00856661|182932390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9401|TWO_SIDED|95.0|0.59|1.62|||Regression, Logistic|||||1.62|0.59|0.9401
91528513|NCT00856661|182932391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.5076|TWO_SIDED|95.0|0.68|2.18|||Regression, Logistic|||All patients treated, who had at least one valid post-baseline assessment of the mRS and with a baseline NIHSS score of 8 to 24. If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if the patient was known to be alive, or 6, if otherwise = dead.||2.18|0.68|0.5076
91528514|NCT00856661|182932392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.6146|TWO_SIDED|95.0|0.72|1.75|||Regression, Logistic|||all patients treated, who had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included||1.75|0.72|0.6146
91492186|NCT03000439|182857085|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.24|-0.10|
91528515|NCT02301156|182932403|SUPERIORITY|||||||0.0463|||||||Cochran-Mantel-Haenszel|P-value was estimated by Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata prior lines of therapy.||||||0.0463
91528516|NCT02301156|182932404|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|P-value was estimated by CMH test stratified by the randomization strata prior lines of therapy.||||||0.0159
91492187|NCT03000439|182857085|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.19|0.15||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-0.19|
91492188|NCT03000439|182857085|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-0.19|0.16||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.16|-0.19|
91492189|NCT03000439|182857085|OTHER||Difference in LS Mean|0.01|||||TWO_SIDED|95.0|-0.2|0.23||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.23|-0.20|
91492190|NCT03000439|182857085|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.02|0.32||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.32|-0.02|
91528517|NCT02301156|182932405|SUPERIORITY||Rate Difference|35.64|||<|0.0001|TWO_SIDED|95.0|21.39|49.88|||Cochran-Mantel-Haenszel|P-value was estimated using CMH test stratified by the randomization strata prior lines of therapy.|95% Confidence Interval (CI) was estimated using Clopper-Pearson method based on the binomial distribution.|||49.88|21.39|<0.0001
91730515|NCT02539394|183355977|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.28|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 arms||||0.280
91730516|NCT02539394|183355977|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.483|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Social is the same across the 2 arms||||0.483
91730517|NCT02539394|183355977|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.07|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Social is the same across the 2 arms||||0.070
91699192|NCT02294175|183293517|SUPERIORITY|||||||0.029||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.029
91699193|NCT02294175|183293518|SUPERIORITY|||||||0.037||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.037
91699194|NCT02294175|183293519|SUPERIORITY|||||||0.012||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.012
91492191|NCT03000439|182857085|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.09|0.4||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.09|
91492192|NCT03000439|182857085|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.16|0.34||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.34|-0.16|
91699195|NCT02294175|183293520|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||.397
91699196|NCT02294175|183293521|SUPERIORITY|||||||0.661||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.||||.661
91699197|NCT02294175|183293522|SUPERIORITY|||||||0.979||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.||||.979
91699198|NCT02294175|183293523|SUPERIORITY|||||||0.999|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.999
91699199|NCT02294175|183293524|SUPERIORITY|||||||0.415|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.415
91730518|NCT02539394|183355977|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.2|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 arms||||0.200
91730519|NCT02539394|183355978|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 arms||||0.148
91730520|NCT02539394|183355978|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Mental is the same across the 2 arms||||0.040
91730521|NCT02539394|183355978|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Mental is the same across the 2 arms||||0.042
91492193|NCT03000439|182857085|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.05|0.36||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.36|-0.05|
91492194|NCT03000439|182857085|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.1|0.43||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.10|
91492195|NCT03000439|182857085|OTHER||Difference in LS Mean|0.17|||||TWO_SIDED|95.0|-0.06|0.39||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-0.06|
91492196|NCT03000439|182857085|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.30|-0.22|
91730522|NCT02539394|183355978|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.319|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 arms||||0.319
91730523|NCT02539394|183355979|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.161|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 arms||||0.161
91730524|NCT02539394|183355979|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.763|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 arms||||0.763
91730525|NCT02539394|183355979|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.178|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 arms||||0.178
91492197|NCT03000439|182857085|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.18|0.49||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-0.18|
91492198|NCT03000439|182857085|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.23|0.55||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.55|-0.23|
91492199|NCT03000439|182857086|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.97|1.4||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.40|-0.97|
91492200|NCT03000439|182857086|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.68|1.84||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.84|-0.68|
91492201|NCT03000439|182857086|OTHER||Difference in LS Mean|1.2|||||TWO_SIDED|95.0|-0.77|3.16||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.16|-0.77|
91492202|NCT03000439|182857086|OTHER||Difference in LS Mean|-0.06|||||TWO_SIDED|95.0|-1.3|1.18||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.18|-1.30|
91492203|NCT03000439|182857086|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.29|0.82||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.82|-0.29|
91492204|NCT03000439|182857086|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.46|0.64||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.64|-0.46|
91492205|NCT03000439|182857086|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-2.05|1.13||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.13|-2.05|
91492206|NCT03000439|182857086|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.18|0.88||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.18|
91492207|NCT03000439|182857086|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.26|0.88||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.26|
91528518|NCT02301156|182932406|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.0961|TWO_SIDED|95.0|0.295|1.113|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.113|0.295|0.0961
91528519|NCT02301156|182932407|SUPERIORITY||Hazard Ratio (HR)|0.569||||0.1486|TWO_SIDED|95.0|0.263|1.234|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.234|0.263|0.1486
91492208|NCT03000439|182857086|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.43|0.99||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.99|-0.43|
91492209|NCT03000439|182857086|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.45|1.03||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.03|-0.45|
91492210|NCT03000439|182857086|OTHER||Difference in LS Mean|0.22|||||TWO_SIDED|95.0|-0.63|1.08||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.08|-0.63|
91492211|NCT03000439|182857086|OTHER||Difference in LS Mean|0.45|||||TWO_SIDED|95.0|-0.66|1.57||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.57|-0.66|
91492212|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.73|0.47||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.47|-0.73|
91492213|NCT03000439|182857087|OTHER||Difference in LS Mean|0.39|||||TWO_SIDED|95.0|-0.81|1.59||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.59|-0.81|
91492214|NCT03000439|182857087|OTHER||Difference in LS Mean|0.7|||||TWO_SIDED|95.0|-0.54|1.95||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-0.54|
91492215|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.10|-0.90|
91528520|NCT02301156|182932408|SUPERIORITY||Hazard Ratio (HR)|2.163||||0.0004|TWO_SIDED|95.0|1.399|3.344|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||3.344|1.399|0.0004
91528521|NCT04195880|182932410|SUPERIORITY||||||<|0.05|TWO_SIDED|5.0|||||negative-binomial regression coefficient|||We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.||||<.05
91492216|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.46|0.13||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.13|-0.46|
91492217|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.32|||||TWO_SIDED|95.0|-0.63|-0.01||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.01|-0.63|
91492218|NCT03000439|182857087|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-2.34|0.15||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-2.34|
91492219|NCT03000439|182857087|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.26|0.4||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.26|
91492220|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.3|0.26||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.26|-0.30|
91492221|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.53|0.43||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.53|
91528522|NCT03012061|182932454|SUPERIORITY||Mean Difference (Net)|0.1758|STANDARD_ERROR_OF_MEAN|0.0426|<|0.001|TWO_SIDED|95.0|0.092|0.2595|||Mixed-model repeated measures (MMRM)||UMEC 31.25 mcg versus placebo|||0.2595|0.0920|<0.001
91528523|NCT03012061|182932454|SUPERIORITY||Mean Difference (Net)|0.1841|STANDARD_ERROR_OF_MEAN|0.0424|<|0.001|TWO_SIDED|95.0|0.1008|0.2675|||MMRM||UMEC 62.5 mcg versus placebo|||0.2675|0.1008|<0.001
91528524|NCT03012061|182932455|SUPERIORITY||Mean Difference (Net)|0.1895|STANDARD_ERROR_OF_MEAN|0.0455|<|0.001|TWO_SIDED|95.0|0.1|0.2789||Analysis of covariance (ANCOVA)|ANCOVA||UMEC 31.25 mcg vs Placebo|||0.2789|0.1000|<0.001
91699200|NCT02294175|183293525|SUPERIORITY|||||||0.993|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.993
91528525|NCT03012061|182932455|SUPERIORITY||Mean Difference (Net)|0.1976|STANDARD_ERROR_OF_MEAN|0.0453|<|0.001|TWO_SIDED|95.0|0.1086|0.2866|||ANCOVA||UMEC 62.5 mcg vs Placebo|||0.2866|0.1086|<0.001
91528526|NCT03012061|182932458|SUPERIORITY||Median Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.083|TWO_SIDED|95.0|-0.2|3.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 4|||3.7|-0.2|0.083
91528527|NCT03012061|182932458|SUPERIORITY||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.11||0.636|TWO_SIDED|95.0|-2.7|1.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 12|||1.7|-2.7|0.636
91528528|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.1||0.115|TWO_SIDED|95.0|-0.4|3.9|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 24|||3.9|-0.4|0.115
91699201|NCT02294175|183293526|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.990
91699202|NCT02548351|183293527|OTHER||Hazard Ratio (HR)|0.814||||0.1028|TWO_SIDED|95.0|0.635|1.043|||Log Rank|||||1.043|0.635|0.1028
91492222|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.56|0.46||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.46|-0.56|
91492223|NCT03000439|182857087|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.74|0.69||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.74|
91492224|NCT03000439|182857087|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.91|1.32||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.32|-0.91|
91528529|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.99||0.336|TWO_SIDED|95.0|-1.0|2.9|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 4|||2.9|-1.0|0.336
91528530|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.787|TWO_SIDED|95.0|-1.9|2.5|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 12|||2.5|-1.9|0.787
91528531|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.625|TWO_SIDED|95.0|-1.6|2.7|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 24|||2.7|-1.6|0.625
91528532|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.79||0.309|TWO_SIDED|95.0|-0.7|2.3|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 4|||2.3|-0.7|0.309
91699203|NCT02548351|183293527|OTHER||Hazard Ratio (HR)|0.772||||0.0444|TWO_SIDED|95.0|0.6|0.994|||Log Rank|||||0.994|0.600|0.0444
91699204|NCT02548351|183293528|OTHER||Difference in percentages|7.1|||<|0.0001|TWO_SIDED|95.0|3.6|10.6|||Cochran-Mantel-Haenszel|||||10.6|3.6|<0.0001
91699205|NCT02548351|183293528|OTHER||Treatment difference|9.4|||<|0.0001|TWO_SIDED|95.0|5.8|13.0|||Cochran-Mantel-Haenszel|||||13.0|5.8|<0.0001
91699206|NCT02548351|183293529|OTHER||Treatment difference|6.7||||0.0004|TWO_SIDED|95.0|3.0|10.4|||Cochran-Mantel-Haenszel|||||10.4|3.0|0.0004
91699207|NCT02548351|183293529|OTHER||Treatment difference|9.0|||<|0.0001|TWO_SIDED|95.0|5.2|12.8|||Cochran-Mantel-Haenszel|||||12.8|5.2|<0.0001
91699208|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9788||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Computer Usage||||0.9788
91699209|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.6571||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Reading||||0.6571
91699210|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.471||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Leisure Activities||||0.4710
91699211|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.736||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Social Activities||||0.7360
91699212|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4999||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Driving||||0.4999
91699213|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1159||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Outdoor Activities||||0.1159
91699214|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4567||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Frequency of Outdoor Activities||||0.4567
91699215|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3439||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Time Spent to Take Care of Eyes||||0.3439
91699216|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3331||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered With Amount of Time Taking Care of Eyes||||0.3331
91699217|NCT03226769|183293609|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4774||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered by Appearance||||0.4774
91699218|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.5457||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyes||||0.5457
91699219|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9786||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Blurred Vision||||0.9786
91699220|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3894||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Dry Eyes||||0.3894
91699221|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0591||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Itchy Eyes||||0.0591
91699222|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1818||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Burning Eyes||||0.1818
91699223|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4284||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Gritty Eyes||||0.4284
91528533|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.521|TWO_SIDED|95.0|-2.1|1.1|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 12|||1.1|-2.1|0.521
91528534|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.81||0.047|TWO_SIDED|95.0|0.0|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 24|||3.2|0.0|0.047
91492225|NCT03000439|182857088|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|0.09|1.92||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.92|0.09|
91699224|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1051||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Painful Eyes||||0.1051
91730526|NCT02539394|183355979|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.091|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 arms||||0.091
91730527|NCT02539394|183355980|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.602|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 arms||||0.602
91730528|NCT02539394|183355980|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.302|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 arms||||0.302
91699225|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.7998||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Watery Eyes||||0.7998
91699226|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1229||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Swollen Eyelids||||0.1229
91699227|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3907||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyelids||||0.3907
91699228|NCT03226769|183293610|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0336||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Crusty Eyelids||||0.0336
91699229|NCT01516008|183293611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|76.35|||<|0.001|TWO_SIDED|95.0|51.0|101.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||101.7|51.0|<0.001
91699230|NCT01516008|183293611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|90.6|||<|0.001|TWO_SIDED|95.0|65.1|116.1||P-value is adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||116.1|65.1|<0.001
91492226|NCT03000439|182857088|OTHER||Difference in LS Mean|1.31|||||TWO_SIDED|95.0|0.4|2.22||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||2.22|0.40|
91492227|NCT03000439|182857088|OTHER||Difference in LS Mean|0.53|||||TWO_SIDED|95.0|-0.47|1.53||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.53|-0.47|
91528535|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.78||0.779|TWO_SIDED|95.0|-1.3|1.8|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 4|||1.8|-1.3|0.779
91699231|NCT01516008|183293612|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
91699232|NCT01516008|183293612|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
91730529|NCT02539394|183355980|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.114|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 arms||||0.114
91492228|NCT03000439|182857088|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.63|1.16||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.16|-0.63|
91492229|NCT03000439|182857088|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.33|0.97||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.97|-0.33|
91730530|NCT02539394|183355980|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.005|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 arms||||0.005
91730531|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.933|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative Eat-10 is the same across the 2 arms||||0.933
91730532|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.95|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative modified Eat-10 is the same across the 2 arms||||0.950
91730533|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.059|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 Eat-10 is the same across the 2 arms||||0.059
91492230|NCT03000439|182857088|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.1|1.2||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.20|-0.10|
91492231|NCT03000439|182857088|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.93|1.33||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.33|-0.93|
91492232|NCT03000439|182857088|OTHER||Difference in LS Mean|0.62|||||TWO_SIDED|95.0|-0.17|1.42||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.42|-0.17|
91492233|NCT03000439|182857088|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.02|0.98||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.98|-0.02|
91492234|NCT03000439|182857088|OTHER||Difference in LS Mean|0.64|||||TWO_SIDED|95.0|-0.3|1.58||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.58|-0.30|
91492235|NCT03000439|182857088|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.4|0.85||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.85|-0.40|
91492236|NCT03000439|182857088|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.36|0.88||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.36|
91699233|NCT01516008|183293613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
91699234|NCT01516008|183293613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
91699235|NCT01516008|183293613|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||0.001
91699236|NCT01516008|183293613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||<0.001
91730534|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 modified Eat-10 is the same across the 2 arms||||0.042
91492237|NCT03000439|182857088|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.87|1.09||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.09|-0.87|
91528536|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.82||0.204|TWO_SIDED|95.0|-0.6|2.6|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 12|||2.6|-0.6|0.204
91699237|NCT01516008|183293613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
91492238|NCT03000439|182857089|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.77|0.67||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.67|-0.77|
91492239|NCT03000439|182857089|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.37|1.53||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.53|-0.37|
91699238|NCT01516008|183293613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
91699239|NCT01516008|183293613|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||0.001
91492240|NCT03000439|182857089|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-1.06|1.3||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.06|
91492241|NCT03000439|182857089|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.27|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.27|
91492242|NCT03000439|182857089|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.83|0.52||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.52|-0.83|
91699240|NCT01516008|183293613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||<0.001
91699241|NCT01516008|183293614|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||0.001
91699242|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
91699243|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
91699244|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
91730535|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.032|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 Eat-10 is the same across the 2 arms||||0.032
91730536|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.014|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 modified Eat-10 is the same across the 2 arms||||0.014
91730537|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks Eat-10 is the same across the 2 arms||||0.030
91699245|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
91699246|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
91699247|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
91699248|NCT01516008|183293614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
91699249|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
91699250|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
91699251|NCT01516008|183293615|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||0.021
91699252|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
91730538|NCT02539394|183355981|EQUIVALENCE|Two-sided 95% confidence interval||||||0.039|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks modified Eat-10 is the same across the 2 arms||||0.039
91699253|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
91699254|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
91699255|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
91730539|NCT02539394|183355982|EQUIVALENCE|Two-sided||||||0.121|||||||Chi-squared|||Proportion of Pre-operative Bazaz Liquid is the same between the 2 arms||||0.121
91699256|NCT01516008|183293615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
91699257|NCT01516008|183293616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.52|||<|0.001|TWO_SIDED|95.0|11.1|22.0|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||22.0|11.1|<0.001
91699258|NCT01516008|183293616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.11|||<|0.001|TWO_SIDED|95.0|13.6|24.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||24.6|13.6|<0.001
91699259|NCT01516008|183293616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.71|||<|0.001|TWO_SIDED|95.0|23.2|46.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||46.2|23.2|<0.001
91699260|NCT01516008|183293616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.04|||<|0.001|TWO_SIDED|95.0|31.5|54.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||54.6|31.5|<0.001
91699261|NCT01516008|183293616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.32|||<|0.001|TWO_SIDED|95.0|81.8|162.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||162.9|81.8|<0.001
91699262|NCT01516008|183293616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.57|||<|0.001||95.0|97.8|179.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||179.4|97.8|<0.001
91699263|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||<|0.001|TWO_SIDED|95.0|5.0|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|5.0|<0.001
91699264|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.13|||<|0.001|TWO_SIDED|95.0|4.9|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|4.9|<0.001
91699265|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.21|||<|0.001|TWO_SIDED|95.0|10.6|19.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||19.8|10.6|<0.001
91699266|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.54|||<|0.001|TWO_SIDED|95.0|10.9|20.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||20.2|10.9|<0.001
91699267|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.76|||<|0.001|TWO_SIDED|95.0|24.3|45.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||45.3|24.3|<0.001
91699268|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.6|||<|0.001|TWO_SIDED|95.0|23.0|44.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||44.2|23.0|<0.001
91699269|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.59|||<|0.001|TWO_SIDED|95.0|39.4|73.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||73.8|39.4|<0.001
91730540|NCT02539394|183355982|EQUIVALENCE|Two-sided||||||0.006|||||||Chi-squared|||Proportion of POD1 Bazaz Liquid is the same between the 2 arms||||0.006
91730541|NCT02539394|183355982|EQUIVALENCE|Two-sided||||||0.329|||||||Chi-squared|||Proportion of POD2 Bazaz Liquid is the same between the 2 arms||||0.329
91730542|NCT02539394|183355982|EQUIVALENCE|Two-sided||||||0.687|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 arms||||0.687
91730543|NCT02539394|183355983|EQUIVALENCE|Two-sided||||||0.066|||||||Chi-squared|||Proportion of Pre-operative Bazaz Solid is the same between the 2 arms||||0.066
91730544|NCT02539394|183355983|EQUIVALENCE|Two-sided||||||0.252|||||||Chi-squared|||Proportion of POD1 Bazaz Solid is the same between the 2 arms||||0.252
91730545|NCT02539394|183355983|EQUIVALENCE|Two-sided||||||0.1|||||||Chi-squared|||Proportion of POD2 Bazaz Solid is the same between the 2 arms||||0.100
91730546|NCT02539394|183355983|EQUIVALENCE|Two-sided||||||0.279|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Solid is the same between the 2 arms||||0.279
91699270|NCT01516008|183293617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|53.48|||<|0.001|TWO_SIDED|95.0|36.2|70.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||70.8|36.2|<0.001
91699271|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.66|||<|0.001|TWO_SIDED|95.0|16.4|30.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||30.9|16.4|<0.001
91492243|NCT03000439|182857089|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.61|0.71||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.61|
91492244|NCT03000439|182857089|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.45|1.25||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.25|-1.45|
91492245|NCT03000439|182857089|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.61|1.23||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.23|-0.61|
91492246|NCT03000439|182857089|OTHER||Difference in LS Mean|0.18|||||TWO_SIDED|95.0|-0.34|0.71||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.34|
91492247|NCT03000439|182857089|OTHER||Difference in LS Mean|0.36|||||TWO_SIDED|95.0|-0.74|1.46||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.46|-0.74|
91492248|NCT03000439|182857089|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.75|0.56||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.56|-0.75|
91492249|NCT03000439|182857089|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.68|0.81||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.81|-0.68|
91492250|NCT03000439|182857089|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.1|0.94||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-1.10|
91492251|NCT03000439|182857090|OTHER||Difference in LS Mean|-1.46|||||TWO_SIDED|95.0|-14.59|11.66||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||11.66|-14.59|
91492252|NCT03000439|182857090|OTHER||Difference in LS Mean|-7.22|||||TWO_SIDED|95.0|-19.62|5.17||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.17|-19.62|
91492253|NCT03000439|182857090|OTHER||Difference in LS Mean|-6.61|||||TWO_SIDED|95.0|-19.36|6.14||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||6.14|-19.36|
91528537|NCT03012061|182932458|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.81||0.066|TWO_SIDED|95.0|-0.1|3.1|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 24|||3.1|-0.1|0.066
91699272|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.24|||<|0.001|TWO_SIDED|95.0|18.9|33.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||33.6|18.9|<0.001
91699273|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.93|||<|0.001|TWO_SIDED|95.0|34.4|65.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||65.4|34.4|<0.001
91492254|NCT03000439|182857090|OTHER||Difference in LS Mean|-8.5|||||TWO_SIDED|95.0|-20.28|3.27||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.27|-20.28|
91492255|NCT03000439|182857090|OTHER||Difference in LS Mean|-3.95|||||TWO_SIDED|95.0|-10.53|2.62||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.62|-10.53|
91492256|NCT03000439|182857090|OTHER||Difference in LS Mean|-1.44|||||TWO_SIDED|95.0|-8.09|5.21||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.21|-8.09|
91492257|NCT03000439|182857090|OTHER||Difference in LS Mean|-4.32|||||TWO_SIDED|95.0|-16.67|8.03||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.03|-16.67|
91492258|NCT03000439|182857090|OTHER||Difference in LS Mean|-2.86|||||TWO_SIDED|95.0|-13.97|8.25||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.25|-13.97|
91492259|NCT03000439|182857090|OTHER||Difference in LS Mean|-10.95|||||TWO_SIDED|95.0|-24.63|2.73||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.73|-24.63|
91492260|NCT03000439|182857090|OTHER||Difference in LS Mean|-4.28|||||TWO_SIDED|95.0|-16.74|8.18||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.18|-16.74|
91699274|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.58|||<|0.001|TWO_SIDED|95.0|43.0|74.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||74.2|43.0|<0.001
91699275|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|111.12|||<|0.001||95.0|76.3|145.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||145.9|76.3|<0.001
91699276|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.21|||<|0.001|TWO_SIDED|95.0|89.2|159.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||159.2|89.2|<0.001
91699277|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|178.91|||<|0.001|TWO_SIDED|95.0|122.4|235.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||235.4|122.4|<0.001
91699278|NCT01516008|183293618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|192.05|||<|0.001|TWO_SIDED|95.0|135.2|248.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||248.9|135.2|<0.001
91699279|NCT01516008|183293619|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
91699280|NCT01516008|183293619|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
91699281|NCT01217476|183293620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.4039|TWO_SIDED|95.0|0.66|2.8|||Regression, Logistic|||||2.80|0.66|0.4039
91492261|NCT03000439|182857090|OTHER||Difference in LS Mean|-8.32|||||TWO_SIDED|95.0|-15.2|-1.43||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||-1.43|-15.20|
91528538|NCT03012061|182932459|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.7|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, Week 4|||3.2|-0.7|0.195
91699282|NCT01217476|183293621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||||1.56|0.52|
91699283|NCT02805660|183293625|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.537|||||||Exact Test|||||||0.537
91699284|NCT02805660|183293625|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.|||||>|0.999|||||||Exact Test|||||||>0.999
91699285|NCT02805660|183293625|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.283|||||||Exact Test|||||||0.283
91699286|NCT02805660|183293625|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.025|||||||Exact Test|||||||0.025
91699287|NCT02572076|183293636|OTHER|Pilot study- no sample size was calculated|number of subjects with adequate cleansi|100.0|||||TWO_SIDED|95.0|66.0|100.0||||||patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.||100|66|
91699288|NCT02778074|183293637|SUPERIORITY||Mean Difference (Final Values)|-2.34|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91699289|NCT03963232|183293647|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.32|-1.32|||Mixed Models Analysis|||||-1.32|-2.32|<.0001
91730547|NCT02539394|183355984|EQUIVALENCE|Two-sided 95% confidence interval||||||0.145|||||||t-test, 2 sided|||The means Pre-operative NDI for the two populations is equal||||0.145
91730548|NCT02539394|183355984|EQUIVALENCE|Two-sided 95% confidence interval||||||0.234|||||||t-test, 2 sided|||The means 4-6 weeks NDI for the two populations is equal||||0.234
91730549|NCT02539394|183355989|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91730550|NCT02301793|183355999|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
91699290|NCT03963232|183293648|SUPERIORITY||Odds Ratio (OR)|2.674|||<|0.0001|TWO_SIDED|95.0|2.01|3.557|||GLIMMIX|||30% responder||3.557|2.010|<.0001
91699291|NCT03963232|183293648|SUPERIORITY||Odds Ratio (OR)|2.481|||<|0.0001|TWO_SIDED|95.0|1.869|3.293|||GLIMMIX|||50% responder||3.293|1.869|<.0001
91699292|NCT03963232|183293648|SUPERIORITY||Odds Ratio (OR)|2.824|||<|0.0001|TWO_SIDED|95.0|2.007|3.972|||GLIMMIX|||75% responder||3.972|2.007|<.0001
91699293|NCT03963232|183293648|SUPERIORITY||Odds Ratio (OR)|3.309|||<|0.0001|TWO_SIDED|95.0|1.989|5.504|||GLIMMIX|||100% responder||5.504|1.989|<.0001
91699294|NCT03963232|183293649|SUPERIORITY||LS Mean Difference|7.07|STANDARD_DEVIATION|0.95|<|0.0001|TWO_SIDED|95.0|5.2|8.95|||Mixed Models Analysis|||||8.95|5.20|<.0001
91699295|NCT03963232|183293650|SUPERIORITY||LS Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.0001
91699296|NCT03963232|183293651|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.35|-1.29|||Mixed Models Analysis|||||-1.29|-2.35|<.0001
91699297|NCT03963232|183293652|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.92|4.81|||Regression, Logistic|||||4.81|1.92|<.0001
91699298|NCT03963232|183293653|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.15|-0.62|||Mixed Models Analysis|||||-0.62|-1.15|<.0001
91699299|NCT03963232|183293654|SUPERIORITY||LS Mean Difference|-18.88|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-23.21|-14.56|||Mixed Models Analysis|||||-14.56|-23.21|<.0001
91699300|NCT03963232|183293655|SUPERIORITY||LS Mean Difference|-19.24|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-23.73|-14.75|||Mixed Models Analysis|||||-14.75|-23.73|<.0001
91699301|NCT03963232|183293656|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.22|-0.1|||Mixed Models Analysis|||||-0.10|-0.22|<.0001
91699302|NCT03963232|183293657|SUPERIORITY||LS Mean Difference|-0.224|STANDARD_ERROR_OF_MEAN|0.1021||0.0284|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|||||-0.02|-0.43|0.0284
91699303|NCT03963232|183293658|SUPERIORITY||LS Mean Difference|-12.429|STANDARD_ERROR_OF_MEAN|3.2484||0.0001|TWO_SIDED|95.0|-18.81|-6.05|||ANCOVA|||||-6.05|-18.81|0.0001
91699304|NCT00356135|183293661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.91|||<|0.0001||95.0|-19.1|-8.73|||ANOVA|Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.|Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.|||-8.73|-19.10|<0.0001
91730551|NCT02301793|183356003|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
91730552|NCT00761137|183356004|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||"Primary outcome was analyzed by a mixed-effects ANOVA model employing subject as a random factor as well as visit and treatment as fixed factors. Intention-to-treat (ITT) sample was analyzed. Unweighted means and their 95% Confidence Interval (CI) are reported, which represent treatment group means adjusted for the effect of visit and removing the intra-subject variability. For all analyses, significance level was set at 5%."||||0.6
91699305|NCT00356135|183293661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.98|||<|0.0001||95.0|-19.26|-8.71|||ANCOVA|||||-8.71|-19.26|<0.0001
91699306|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.4||||0.4055|TWO_SIDED|95.0|-8.22|3.35||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.35|-8.22|0.4055
91699307|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-17.51||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-17.51|-29.30|<0.0001
91699308|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.2||||0.068|TWO_SIDED|95.0|-8.82|0.32||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.32|-8.82|0.0680
91699309|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-33.2|-23.94||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|Comparison of MPA to 20 uM ADP at 24 hours||-23.94|-33.20|<0.0001
91528539|NCT03012061|182932459|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.84||0.457|TWO_SIDED|95.0|-1.0|2.3|||MMRM||UMEC 31.25 mcg versus Placebo, Week 12|||2.3|-1.0|0.457
91699310|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.96|-9.65||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.65|-19.96|<0.0001
91699311|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.87|-9.32||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.32|-19.87|<0.0001
91699312|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.3|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.30|<0.0001
91730553|NCT00834587|183356009|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|92.4|106.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.2|92.4|
91730554|NCT00834587|183356010|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.7||||||90.0|98.8|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.6|98.8|
91730555|NCT00834587|183356011|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.6||||||90.0|98.8|102.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.5|98.8|
91730556|NCT00834587|183356012|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.7||||||90.0|97.3|106.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.3|97.3|
91730557|NCT00834587|183356013|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.2||||||90.0|96.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.0|96.5|
91730558|NCT00834587|183356014|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|96.5|101.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.8|96.5|
91730559|NCT00581100|183356028|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
91730560|NCT00581100|183356028|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730561|NCT00581100|183356029|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
91730562|NCT00581100|183356029|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730563|NCT00581100|183356030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91492262|NCT03000439|182857090|OTHER||Difference in LS Mean|-4.84|||||TWO_SIDED|95.0|-12.6|2.92||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.92|-12.60|
91492263|NCT03000439|182857090|OTHER||Difference in LS Mean|-1.34|||||TWO_SIDED|95.0|-5.16|2.48||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.48|-5.16|
91730564|NCT00581100|183356030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91730565|NCT00581100|183356030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730566|NCT00581100|183356030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730567|NCT00581100|183356031|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.007
91730568|NCT00581100|183356031|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
91730569|NCT00581100|183356031|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730570|NCT00581100|183356031|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730571|NCT00581100|183356032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91492264|NCT03000439|182857091|OTHER||Difference in LS Mean|-6.05|||||TWO_SIDED|95.0|-16.3|4.19||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.19|-16.30|
91528540|NCT03012061|182932459|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.07||0.3|TWO_SIDED|95.0|-1.0|3.2|||MMRM||UMEC 31.25 mcg versus Placebo, Week 24|||3.2|-1.0|0.300
91492265|NCT03000439|182857091|OTHER||Difference in LS Mean|-10.46|||||TWO_SIDED|95.0|-21.68|0.77||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.77|-21.68|
91492266|NCT03000439|182857091|OTHER||Difference in LS Mean|-10.86|||||TWO_SIDED|95.0|-23.75|2.03||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.03|-23.75|
91492267|NCT03000439|182857091|OTHER||Difference in LS Mean|-13.15|||||TWO_SIDED|95.0|-25.83|-0.46||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.46|-25.83|
91492268|NCT03000439|182857091|OTHER||Difference in LS Mean|-7.02|||||TWO_SIDED|95.0|-13.56|-0.47||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.47|-13.56|
91492269|NCT03000439|182857091|OTHER||Difference in LS Mean|-4.53|||||TWO_SIDED|95.0|-11.0|1.95||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-11.00|
91492270|NCT03000439|182857091|OTHER||Difference in LS Mean|-9.35|||||TWO_SIDED|95.0|-22.24|3.54||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.54|-22.24|
91699313|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.59|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.59|<0.0001
91492271|NCT03000439|182857091|OTHER||Difference in LS Mean|-6.75|||||TWO_SIDED|95.0|-18.34|4.83||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.83|-18.34|
91492272|NCT03000439|182857091|OTHER||Difference in LS Mean|-15.49|||||TWO_SIDED|95.0|-30.36|-0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.63|-30.36|
91492273|NCT03000439|182857091|OTHER||Difference in LS Mean|-7.99|||||TWO_SIDED|95.0|-21.0|5.03||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.03|-21.00|
91492274|NCT03000439|182857091|OTHER||Difference in LS Mean|-10.49|||||TWO_SIDED|95.0|-17.67|-3.31||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-3.31|-17.67|
91492275|NCT03000439|182857091|OTHER||Difference in LS Mean|-5.93|||||TWO_SIDED|95.0|-13.53|1.67||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.67|-13.53|
91528541|NCT03012061|182932459|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.14|TWO_SIDED|95.0|-0.5|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 4|||3.3|-0.5|0.140
91699314|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.5501|TWO_SIDED|95.0|-5.85|3.14||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.14|-5.85|0.5501
91699315|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-17.0|||<|0.0001|TWO_SIDED|95.0|-21.55|-12.37||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.37|-21.55|<0.0001
91492276|NCT03000439|182857091|OTHER||Difference in LS Mean|-2.57|||||TWO_SIDED|95.0|-6.37|1.24||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.24|-6.37|
91492277|NCT03000439|182857092|OTHER||Difference in LS Mean|0.51|||||TWO_SIDED|95.0|0.2|2.22||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.22|0.20|
91492278|NCT03000439|182857092|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-0.2|1.85||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.85|-0.20|
91492279|NCT03000439|182857092|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.65|1.27||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-0.65|
91492280|NCT03000439|182857092|OTHER||Difference in LS Mean|0.57|||||TWO_SIDED|95.0|-0.26|1.41||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.41|-0.26|
91492281|NCT03000439|182857092|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.78|1.1||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.10|-0.78|
91492282|NCT03000439|182857092|OTHER||Difference in LS Mean|0.66|||||TWO_SIDED|95.0|-0.18|1.49||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.49|-0.18|
91730572|NCT00581100|183356032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91492283|NCT03000439|182857092|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.43|1.27||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-1.43|
91492284|NCT03000439|182857092|OTHER||Difference in LS Mean|-0.07|||||TWO_SIDED|95.0|-0.65|0.5||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.65|
91492285|NCT03000439|182857092|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.51|0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.63|-0.51|
91492286|NCT03000439|182857092|OTHER||Difference in LS Mean|-0.04|||||TWO_SIDED|95.0|-0.55|0.47||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.47|-0.55|
91492287|NCT03000439|182857092|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.82|0.5||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.82|
91492288|NCT03000439|182857092|OTHER||Difference in LS Mean|-0.14|||||TWO_SIDED|95.0|-1.51|1.22||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.22|-1.51|
91492289|NCT03000439|182857092|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.05|0.88||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.88|-1.05|
91492290|NCT03000439|182857093|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.32|1.3||||||DB at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.32|
91492291|NCT03000439|182857093|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.64|1.61||||||DB at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.61|-0.64|
91492292|NCT03000439|182857093|OTHER||Difference in LS Mean|0.03|||||TWO_SIDED|95.0|-1.02|1.07||||||DB at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.07|-1.02|
91492293|NCT03000439|182857093|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.69|1.14||||||DB at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.69|
91730573|NCT00581100|183356032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730574|NCT00581100|183356032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730575|NCT00581100|183356033|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.069
91492294|NCT03000439|182857093|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-1.05|1.22||||||DB at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.22|-1.05|
91492295|NCT03000439|182857093|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.6|1.16||||||DB at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.60|
91492296|NCT03000439|182857093|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
91492297|NCT03000439|182857093|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
91492298|NCT03000439|182857093|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.58|0.73||||||DB at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.73|-0.58|
91492299|NCT03000439|182857093|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.53|0.65||||||DB at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.65|-0.53|
91492300|NCT03000439|182857093|OTHER||Difference in LS Mean|-0.12|||||TWO_SIDED|95.0|-0.87|0.64||||||DB at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.64|-0.87|
91528542|NCT03012061|182932459|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|0.84||0.045|TWO_SIDED|95.0|0.0|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 12|||3.3|0.0|0.045
91730576|NCT00581100|183356033|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
91699316|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.1||||0.0752|TWO_SIDED|95.0|-8.58|0.42||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.42|-8.58|0.0752
91699317|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-24.81|-15.64||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.64|-24.81|<0.0001
91492301|NCT03000439|182857093|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.13|1.54||||||DB at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.54|-1.13|
91492302|NCT03000439|182857093|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-1.0|1.11||||||DB at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.11|-1.00|
91492303|NCT03000439|182857096|OTHER||Difference in LS Mean|6.0|||||TWO_SIDED|95.0|-8.35|20.36||||||CHQ01-Global Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||20.36|-8.35|
91492304|NCT03000439|182857096|OTHER||Difference in LS Mean|2.85|||||TWO_SIDED|95.0|-12.43|18.14||||||CHQ01-Global Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.14|-12.43|
91492305|NCT03000439|182857096|OTHER||Difference in LS Mean|-4.19|||||TWO_SIDED|95.0|-15.78|7.4||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.40|-15.78|
91528543|NCT03012061|182932459|SUPERIORITY||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|1.3|5.5|||MMRM||UMEC 62.5 mcg versus Placebo, Week 24|||5.5|1.3|0.002
91730577|NCT00581100|183356033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91492306|NCT03000439|182857096|OTHER||Difference in LS Mean|2.31|||||TWO_SIDED|95.0|-37.06|41.68||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||41.68|-37.06|
91730578|NCT00581100|183356033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730579|NCT00581100|183356034|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91492307|NCT03000439|182857096|OTHER||Difference in LS Mean|-5.47|||||TWO_SIDED|95.0|-17.37|6.43||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.43|-17.37|
91528544|NCT00309608|182932484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.95|-0.39||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 10 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.39|-0.95|<0.0001
91730580|NCT00581100|183356034|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91492308|NCT03000439|182857096|OTHER||Difference in LS Mean|6.82|||||TWO_SIDED|95.0|-20.92|34.57||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||34.57|-20.92|
91492309|NCT03000439|182857096|OTHER||Difference in LS Mean|-6.22|||||TWO_SIDED|95.0|-18.95|6.5||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.50|-18.95|
91492310|NCT03000439|182857096|OTHER||Difference in LS Mean|11.09|||||TWO_SIDED|95.0|-46.24|68.42||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||68.42|-46.24|
91730581|NCT00581100|183356035|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91492311|NCT03000439|182857096|OTHER||Difference in LS Mean|-1.45|||||TWO_SIDED|95.0|-13.97|11.06||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||11.06|-13.97|
91492312|NCT03000439|182857096|OTHER||Difference in LS Mean|17.2|||||TWO_SIDED|95.0|-28.01|62.41||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||62.41|-28.01|
91492313|NCT03000439|182857096|OTHER||Difference in LS Mean|-5.15|||||TWO_SIDED|95.0|-13.24|2.93||||||CHQ01-Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-13.24|
91492314|NCT03000439|182857096|OTHER||Difference in LS Mean|-15.03|||||TWO_SIDED|95.0|-33.12|3.06||||||CHQ01-Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.06|-33.12|
91492315|NCT03000439|182857096|OTHER||Difference in LS Mean|-5.32|||||TWO_SIDED|95.0|-16.92|6.29||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.29|-16.92|
91528545|NCT00309608|182932484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.01|-0.44||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.44|-1.01|<0.0001
91699318|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.5||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.50|-17.21|<0.0001
91699319|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.79|-5.79||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.79|-15.79|<0.0001
91492316|NCT03000439|182857096|OTHER||Difference in LS Mean|-7.24|||||TWO_SIDED|95.0|-20.35|5.87||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.87|-20.35|
91492317|NCT03000439|182857096|OTHER||Difference in LS Mean|4.44|||||TWO_SIDED|95.0|-6.18|15.07||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.07|-6.18|
91492318|NCT03000439|182857096|OTHER||Difference in LS Mean|-7.46|||||TWO_SIDED|95.0|-24.37|9.45||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.45|-24.37|
91492319|NCT03000439|182857096|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-9.14|9.13||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.13|-9.14|
91492320|NCT03000439|182857096|OTHER||Difference in LS Mean|-7.59|||||TWO_SIDED|95.0|-33.87|18.7||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.70|-33.87|
91492321|NCT03000439|182857096|OTHER||Difference in LS Mean|4.98|||||TWO_SIDED|95.0|-4.81|14.77||||||CHQ01-General Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||14.77|-4.81|
91492322|NCT03000439|182857096|OTHER||Difference in LS Mean|-1.02|||||TWO_SIDED|95.0|-20.31|18.28||||||CHQ01-General Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.28|-20.31|
91492323|NCT03000439|182857096|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.4|0.33||||||CHQ01-Change in Health Subscale Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.40|
91492324|NCT03000439|182857096|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.68|1.65||||||CHQ01-Change in Health Subscale Score; DB Week48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.65|-0.68|
91492325|NCT03000439|182857096|OTHER||Difference in LS Mean|2.25|||||TWO_SIDED|95.0|-10.59|15.1||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.10|-10.59|
91528546|NCT00309608|182932484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0055||95.0|-0.68|-0.12||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.12|-0.68|0.0055
91699320|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.41|-7.72||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.72|-17.41|<0.0001
91699321|NCT00356135|183293662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-16.8|-6.82||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.82|-16.80|<0.0001
91699322|NCT00356135|183293663|SUPERIORITY_OR_OTHER|||||||0.1824|||||||t-test, 2 sided|||The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.||||0.1824
91699323|NCT00356135|183293663|SUPERIORITY_OR_OTHER|||||||0.1101|||||||F-test|||The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.||||0.1101
91699324|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.3466|TWO_SIDED|95.0|-9.5|3.37||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.37|-9.50|0.3466
91699325|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-33.4|-20.33||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-20.33|-33.40|<0.0001
91730582|NCT00581100|183356035|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91699326|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.3||||0.0127|TWO_SIDED|95.0|-13.04|-1.6||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-1.60|-13.04|0.0127
91730583|NCT00581100|183356035|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730584|NCT00581100|183356035|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730585|NCT00581100|183356036|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91730586|NCT00581100|183356036|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
91699327|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-34.0|||<|0.0001|TWO_SIDED|95.0|-39.99|-28.42||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-28.42|-39.99|<0.0001
91699328|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-25.58|-11.09||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-11.09|-25.58|<0.0001
91699329|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-27.09|-12.26||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.26|-27.09|<0.0001
91730587|NCT00581100|183356036|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730588|NCT00581100|183356036|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
91730589|NCT00581100|183356037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91699330|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-28.42|-14.77||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-14.77|-28.42|<0.0001
91699331|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.61|-15.63||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.63|-29.61|<0.0001
91699332|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.6||||0.4954|TWO_SIDED|95.0|-3.11|6.38||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||6.38|-3.11|0.4954
91699333|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.92|-6.24||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.24|-15.92|<0.0001
91699334|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.3||||0.1971|TWO_SIDED|95.0|-8.31|1.74||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||1.74|-8.31|0.1971
91699335|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-20.98|-10.75||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-10.75|-20.98|<0.0001
91730590|NCT00581100|183356037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91528547|NCT00309608|182932484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.99|-0.46|||Pairwise comparison based on ANCOVA|||"Placebo vs. Linagliptin 10 mg~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)."||-0.46|-0.99|<0.0001
91528548|NCT00309608|182932484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.02|-0.48|||Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.48|-1.02|<0.0001
91730591|NCT00581100|183356038|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
91730592|NCT00581100|183356038|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
91528549|NCT00309608|182932484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0049||95.0|-0.66|-0.12|||Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.12|-0.66|0.0049
91528550|NCT00309608|182932485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.575||||0.0054|TWO_SIDED|95.0|2.367|145.781|||Regression, Logistic|||Linagliptin 10 mg vs. Placebo||145.781|2.367|0.0054
91699336|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-18.81|-7.32||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.32|-18.81|<0.0001
91699337|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0||||0.0001|TWO_SIDED|95.0|-17.91|-6.09||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.09|-17.91|0.0001
91730593|NCT00581100|183356039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
91730594|NCT00581100|183356039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
91699338|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.64|-6.32||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-6.32|-15.64|<0.0001
91492326|NCT03000439|182857096|OTHER||Difference in LS Mean|-25.07|||||TWO_SIDED|95.0|-60.96|10.82||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||10.82|-60.96|
91492327|NCT03000439|182857096|OTHER||Difference in LS Mean|1.87|||||TWO_SIDED|95.0|-13.55|17.29||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||17.29|-13.55|
91528551|NCT00309608|182932485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.715||||0.0214|TWO_SIDED|95.0|1.439|95.351|||Regression, Logistic|||Linagliptin 5 mg vs. Placebo||95.351|1.439|0.0214
91699339|NCT00356135|183293664|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.67|-5.09||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.09|-14.67|<0.0001
91699340|NCT00356135|183293665|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0005
91699341|NCT00356135|183293665|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||<0.0001
91699342|NCT00356135|183293665|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0150
91699343|NCT00356135|183293665|SUPERIORITY_OR_OTHER|||||||0.0152||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0152
91699344|NCT00356135|183293665|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0153
91699345|NCT00356135|183293665|SUPERIORITY_OR_OTHER|||||||0.0018||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0018
91730595|NCT00581100|183356040|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91528552|NCT00309608|182932485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.776||||0.0167|TWO_SIDED|95.0|1.586|102.895|||Regression, Logistic|||Linagliptin 1 mg vs. Placebo||102.895|1.586|0.0167
91699346|NCT05270395|183293686|SUPERIORITY||Odds Ratio (OR)|8.02||||0.02|TWO_SIDED|95.0|1.38|46.69|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||46.69|1.38|0.02
91699347|NCT05270395|183293687|SUPERIORITY||Odds Ratio (OR)|1.35||||0.63|TWO_SIDED|95.0|0.4|4.56|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||4.56|0.40|0.63
91699348|NCT05270395|183293688|SUPERIORITY||Odds Ratio (OR)|0.29||||0.13|TWO_SIDED|95.0|0.06|1.46|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||1.46|0.06|0.13
91699349|NCT05270395|183293689|SUPERIORITY||Odds Ratio (OR)|0.54||||0.4|TWO_SIDED|95.0|0.13|2.24|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||2.24|0.13|0.40
91699350|NCT05270395|183293690|SUPERIORITY||Odds Ratio (OR)|2.22||||0.29|TWO_SIDED|95.0|0.51|9.62|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.62|0.51|0.29
91699351|NCT05270395|183293691|SUPERIORITY||Odds Ratio (OR)|3.55||||0.07|TWO_SIDED|95.0|0.88|14.32|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||14.32|0.88|0.07
91699352|NCT05270395|183293692|SUPERIORITY||Odds Ratio (OR)|3.93||||0.09|TWO_SIDED|95.0|0.82|18.89|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||18.89|0.82|0.09
91699353|NCT05270395|183293693|SUPERIORITY||Odds Ratio (OR)|1.73||||0.42|TWO_SIDED|95.0|0.46|6.43|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||6.43|0.46|0.42
91699354|NCT05270395|183293694|SUPERIORITY||Odds Ratio (OR)|2.86||||0.08|TWO_SIDED|95.0|0.87|9.42|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.42|0.87|0.08
91699355|NCT05270395|183293695|SUPERIORITY||Odds Ratio (OR)|8.29||||0.004|TWO_SIDED|95.0|1.99|34.49|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||34.49|1.99|0.004
91699356|NCT03055494|183293696|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|76.1|||||TWO_SIDED|95.0|63.3|88.8|||95% confidence interval|"Statistical analysis of no response of skin histology/K16 expression to treatment at Week 12"|||"A patient with missing assessment was considered as having a yes response of skin histology/K16 expression to treatment regardless of the reason for missing data (eg, premature study discontinuation, missed visit, administrative issues). However, missing baseline value was not imputed."|88.8|63.3|
91699357|NCT03055494|183293697|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|55.8|||||TWO_SIDED|95.0|42.3|69.3|||95% confidence interval|||||69.3|42.3|
91699358|NCT05027048|183293727|SUPERIORITY||Mean Difference (Net)|211.0|||<|0.05|TWO_SIDED|95.0|-33.0|410.0||a priori threshold for statistical significance p\<0.05|inverse Gaussian distribution and log li|Inverse Gaussian distribution and log link fit to estimate the effect size and 95% CIs|Inverse gaussian regression with a log link was used to calculate the mean reduction in blood loss in the calcium group relative to placebo group.|||410|-33|<0.05
91699359|NCT05027048|183293728|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||Regression (poisson with robust SE)|||||1.03|0.48|
91699360|NCT05027048|183293729|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.46|1.23|||Poisson regression with robust SE|||||1.23|0.46|
91699361|NCT05027048|183293730|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.2|1.56||||||||1.56|0.2|
91699362|NCT05027048|183293731|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.6|0.2|||Regression, Linear|Data were log transformed to approximate a normal distribution prior to linear regression.||||0.2|-3.6|
91699363|NCT05027048|183293733|SUPERIORITY|||||||0.415|||||||Wilcoxon (Mann-Whitney)|||||||0.415
91699364|NCT05027048|183293734|SUPERIORITY|||||||0.566|||||||Wilcoxon (Mann-Whitney)|||||||0.566
91699365|NCT05027048|183293736|SUPERIORITY|||||||0.348|||||||ANOVA|||Repeated measures ANOVA used to analyze differences between groups.||||0.348
91699366|NCT05027048|183293737|SUPERIORITY|||||||0.011|||||||ANOVA|Repeated measures ANOVA.||Repeated measures ANOVA used to assess for difference between groups in the % change from baseline heart rate.||||0.011
91699367|NCT05027048|183293739|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
91699368|NCT05027048|183293740|OTHER||||||||||||||||||"Note: a two-compartment pharmacokinetic model was generated in NONMEM using 6 venous blood ionized calcium measurements per participant at random times. The change in ionized calcium was defined as a measured value minus the measured baseline for the patient.~Once the two-compartment pharmacokinetic model was generated, NONMEM was used to generate a predicted ionized calcium concentration at 10 minutes (Tmax) for each participant to generate mean and 95% confidence interval."|||
91730596|NCT00581100|183356040|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730597|NCT00581100|183356041|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730598|NCT00581100|183356041|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730599|NCT00581100|183356042|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730600|NCT00581100|183356042|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<Table 8-14\> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Mixed Models Analysis|||||||<0.0001
91730601|NCT00581100|183356043|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91528553|NCT00309608|182932485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|31.36||||0.001|TWO_SIDED|95.0|4.063|242.028|||Regression, Logistic|||Glimepiride vs. Placebo||242.028|4.063|0.0010
91699369|NCT05027048|183293742|SUPERIORITY||Mean Difference (Net)|356.0|||<|0.05|TWO_SIDED|95.0|159.0|515.0|||Inverse Gaussian regression, log link||Reduction in blood loss was calculated by inverse Gaussian regression with a log link as detailed in the description of statistical methods for the primary outcome.|||515|159|<0.05
91699370|NCT03051516|183293761|SUPERIORITY|||||||0.89|||||||Chi-squared|||This p-value compares HPV16 persistence by study arm.||||0.89
91699371|NCT03051516|183293761|SUPERIORITY|||||||0.65|||||||Chi-squared|||This p-value compares HPV18/45 persistence by study arm.||||0.65
91699372|NCT03051516|183293761|SUPERIORITY|||||||0.056|||||||Chi-squared|||This p-value compares HPV31/33/52/58 persistence by study arm.||||0.056
91699373|NCT03051516|183293761|SUPERIORITY|||||||0.38|||||||Chi-squared|||This p-value compares HPV35/39/51/56/59 persistence by study arm.||||0.38
91699374|NCT03051516|183293761|SUPERIORITY|||||||0.33||||||This p-value compares overall HPV persistence and is not specific to HPV genotype.|Chi-squared|||||||0.33
91699375|NCT03051516|183293762|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
91699376|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.135|||||||Chi-squared|||This comparison is specific to the incidence of fever or chills.||||0.135
91699377|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.64|||||||Chi-squared|||This comparison is specific to the incidence of headache.||||0.640
91699378|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.838|||||||Chi-squared|||This comparison is specific to the incidence of fatigue.||||0.838
91699379|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.917|||||||Chi-squared|||This comparison is specific to the incidence of muscle aches.||||0.917
91699380|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.005|||||||Chi-squared|||This comparison is specific to the incidence of pain at injection site.||||0.005
91699381|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.001|||||||Chi-squared|||This comparison is specific to the incidence of tenderness at injection site.||||0.001
91699382|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.004|||||||Chi-squared|||This comparison is specific to the incidence of swelling at injection site.||||0.004
91699383|NCT03051516|183293763|OTHER|Descriptive analysis||||||0.133|||||||Chi-squared|||This comparison is specific to the incidence of medical attention/medication required.||||0.133
91699384|NCT03051516|183293764|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)||||0.93
91699385|NCT03051516|183293764|SUPERIORITY|||||||0.77|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)||||0.77
91699386|NCT03051516|183293764|SUPERIORITY|||||||0.57|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)||||0.57
91699387|NCT03051516|183293764|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)||||0.73
91699388|NCT03051516|183293764|SUPERIORITY|||||||0.998|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)||||0.998
91699389|NCT03051516|183293764|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)||||0.93
91730602|NCT00581100|183356043|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
91730603|NCT00993473|183356068|NON_INFERIORITY_OR_EQUIVALENCE|"Noninferiority would be demonstrated if the upper bound of the 95% confidence interval (CI) for the ratio of the rate of all hypoglycemia in the Lantus group to the rate in the NPH group was \<1.15. Superiority would be demonstrated if the upper bound of the 95% CI was \<1. The margin for noninferiority corresponded to one-half of the 30% difference in hypoglycemia event rate considered as a clinically significant difference by American Diabetes Association 2005 Working Group on Hypoglycemia."|Risk Ratio (RR)|1.18|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.97|1.44|||Generalized Linear Model|"A stepwise closed testing approach was used for the primary all hypoglycemia outcome analysis to assess noninferiority and superiority sequentially."|Risk ratio between treatment groups (Lantus/NPH) estimated by Generalized Linear Model with fixed effect terms for randomization strata and treatment.|"The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of all hypoglycemia of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment."||1.44|0.97|
91699390|NCT03051516|183293764|SUPERIORITY|||||||0.95|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)||||0.95
91699391|NCT03051516|183293764|SUPERIORITY|||||||0.91|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)||||0.91
91699392|NCT03051516|183293764|SUPERIORITY|||||||0.22|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)||||0.22
91699393|NCT03051516|183293764|SUPERIORITY|||||||0.27|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)||||0.27
91730604|NCT00839930|183356089|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.39||||||90.0|87.33|99.86|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.86|87.33|
91730605|NCT00839930|183356090|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.14||||||90.0|91.04|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.52|91.04|
91492328|NCT03000439|182857096|OTHER||Difference in LS Mean|-9.19|||||TWO_SIDED|95.0|-48.91|30.53||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||30.53|-48.91|
91492329|NCT03000439|182857096|OTHER||Difference in LS Mean|-3.97|||||TWO_SIDED|95.0|-12.84|4.9||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.90|-12.84|
91492330|NCT03000439|182857096|OTHER||Difference in LS Mean|-9.3|||||TWO_SIDED|95.0|-32.35|13.75||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||13.75|-32.35|
91492331|NCT03000439|182857096|OTHER||Difference in LS Mean|-3.52|||||TWO_SIDED|95.0|-14.84|7.81||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.81|-14.84|
91528554|NCT00309608|182932486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.5|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001||95.0|-41.4|-17.5|||Pairwise comparison based on ANCOVA|||Linagliptin 10mg vs. Placebo||-17.5|-41.4|<0.0001
91699394|NCT03051516|183293764|SUPERIORITY|||||||0.72|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)||||0.72
91699395|NCT03051516|183293764|SUPERIORITY|||||||0.71|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)||||0.71
91699396|NCT03051516|183293764|SUPERIORITY|||||||0.11|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm II (Placebo)||||0.11
91699397|NCT03051516|183293764|SUPERIORITY|||||||0.58|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm II (Placebo)||||0.58
91699398|NCT03051516|183293764|SUPERIORITY|||||||0.81|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm II (Placebo)||||0.81
91699399|NCT03051516|183293764|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm II (Placebo)||||0.73
91699400|NCT05139303|183293812|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91699401|NCT04507256|183293826|OTHER|Bioavailability|Ratio of geometric mean AUCinf|68.69|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895.|Bioavailability of AZD8895 at the end of study (Day 361)||||
91730606|NCT00839930|183356091|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.64||||||90.0|92.13|101.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.37|92.13|
91492332|NCT03000439|182857096|OTHER||Difference in LS Mean|-20.42|||||TWO_SIDED|95.0|-79.03|38.18||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||38.18|-79.03|
91528555|NCT00309608|182932486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.92|STANDARD_ERROR_OF_MEAN|6.16|<|0.0001||95.0|-47.0|-22.8|||Pairwise comparison based on ANCOVA|||Linagliptin 5mg vs. Placebo||-22.8|-47.0|<0.0001
91528556|NCT00309608|182932486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.95|STANDARD_ERROR_OF_MEAN|6.13||0.0022||95.0|-31.0|-6.87|||Pairwise comparison based on ANCOVA|||Linagliptin 1 mg vs. Placebo||-6.87|-31.0|0.0022
91699402|NCT04507256|183293826|OTHER|Bioavailability|Ratio of geometric mean AUCinf|65.02|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD1061.|Bioavailability of AZD1061 at the end of study (Day 361)||||
91699403|NCT02858180|183293844|OTHER||Proportion|86.7|||||TWO_SIDED|95.0|59.5|98.3||||||||98.3|59.5|
91699404|NCT00844480|183293847|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
91699405|NCT00574249|183293852|SUPERIORITY_OR_OTHER|||||||0.086||||||Level of significance 5%; no adjustment for multiple comparisons necessary.|Cochran-Mantel-Haenszel|Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).||Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.||||0.086
91699406|NCT00574249|183293853|SUPERIORITY_OR_OTHER|||||||0.565||95.0|||||Fisher Exact|||||||0.565
91699407|NCT00574249|183293854|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
91699408|NCT00574249|183293855|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
91730607|NCT02500836|183356092|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
91730608|NCT02500836|183356093|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
91730609|NCT03253627|183356125|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||baseline||||0.460
91730610|NCT03253627|183356125|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||3 months||||0.896
91699409|NCT00574249|183293856|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
91699410|NCT00574249|183293857|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
91699411|NCT00574249|183293858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74||||0.204||95.0|-5.3|24.78|||ANOVA|One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.||||24.78|-5.30|0.204
91699412|NCT00574249|183293859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.55||||0.272||95.0|-48.92|13.82|||ANOVA|One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.||||13.82|-48.92|0.272
91699413|NCT00574249|183293860|SUPERIORITY_OR_OTHER|||||||0.413||95.0|||||Fisher Exact|||||||0.413
91492333|NCT03000439|182857099|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-1.02|0.54||||||CHAQ-Discomfort Index at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.54|-1.02|
91492334|NCT03000439|182857099|OTHER||Difference in LS Mean|0.54|||||TWO_SIDED|95.0|-0.49|1.57||||||CHAQ-Discomfort Index at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.57|-0.49|
91492335|NCT03000439|182857099|OTHER||Difference in LS Mean|0.47|||||TWO_SIDED|95.0|-1.01|0.9||||||CHAQ-Discomfort Index at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.90|-1.01|
91492336|NCT03000439|182857099|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.49|1.58||||||CHAQ-Discomfort Index at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.58|-0.49|
91492337|NCT03000439|182857099|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.98|1.45||||||CHAQ-Discomfort Index at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.45|-0.98|
91492338|NCT03000439|182857099|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.51|1.14||||||CHAQ-Discomfort Index at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.51|
91699414|NCT00574249|183293861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91730611|NCT03253627|183356126|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||baseline||||0.374
91699415|NCT00574249|183293862|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Fisher Exact|||||||0.028
91699416|NCT00574249|183293863|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||ANOVA|One-way ANOVA.||||||0.228
91528557|NCT02441946|182932625|SUPERIORITY||Ratio of Geometric Means|0.19|||<|0.001|TWO_SIDED|90.0|0.13|0.28|||t-test, 1 sided|||||0.28|0.13|<0.001
91528558|NCT02441946|182932625|SUPERIORITY||Ratio of Geometric Means|0.25|||<|0.001|TWO_SIDED|90.0|0.17|0.38|||t-test, 1 sided|||||0.38|0.17|<0.001
91492339|NCT03000439|182857099|OTHER||Difference in LS Mean|-0.42|||||TWO_SIDED|95.0|-1.87|1.03||||||CHAQ-Discomfort Index at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.03|-1.87|
91492340|NCT03000439|182857099|OTHER||Difference in LS Mean|-0.33|||||TWO_SIDED|95.0|-1.53|0.88||||||CHAQ-Discomfort Index at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-1.53|
91699417|NCT00574249|183293864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|One-way ANOVA.||||||< 0.001
91699418|NCT00574249|183293865|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|One-way ANOVA.||||||0.001
91699419|NCT00574249|183293866|SUPERIORITY_OR_OTHER|||||||0.764||95.0|||||ANOVA|One-way ANOVA.||||||0.764
91699420|NCT00574249|183293867|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||ANOVA|One-way ANOVA.||||||0.437
91699421|NCT00574249|183293868|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|One-way ANOVA.||||||0.740
91699422|NCT00574249|183293869|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANOVA|One-way ANOVA.||||||0.634
91699423|NCT03197870|183293870|SUPERIORITY|The primary hypotheses was tested in the modified intent-to-treat population using a Fisher's Exact Test with a 2-sided 5% significance level. razuprotafib 15 mg twice daily was tested first. If this was found to be statistically significant, then razuprotafib 15 mg once daily will be tested for statistical significance, at the same significance level.||||||0.495||||||Missing data was imputed using last observation carried forward; baseline values were not carried forward.|Fisher Exact|||The primary hypotheses tested was that razuprotafib 15 mg twice daily and razuprotafib 15 mg once daily will be superior to placebo in the improvement of diabetic retinopathy as measured by the Early Treatment Diabetic Retinopathy Study severity scale change from baseline at 48 weeks.||||0.495
91699424|NCT01542034|183293891|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.702|||<|0.001|TWO_SIDED|95.0|2.808|4.88|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||4.880|2.808|<0.001
91730612|NCT03253627|183356126|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||6 months||||0.236
91730613|NCT03253627|183356127|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||baseline||||0.180
91730614|NCT03253627|183356127|SUPERIORITY|||||||0.822|||||||t-test, 2 sided|||6 months||||0.822
91730615|NCT03253627|183356128|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||baseline||||.715
91730616|NCT03253627|183356128|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||3 months||||0.861
91730617|NCT03253627|183356128|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||6 months||||.790
91730618|NCT03253627|183356129|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||baseline||||0.452
91492341|NCT03000439|182857099|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.36|0.74||||||CHAQ-Discomfort Index at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.36|
91492342|NCT03000439|182857099|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.55|0.69||||||CHAQ-Discomfort Index at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.55|
91492343|NCT03000439|182857099|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.01|0.39||||||CHAQ-Discomfort Index at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-1.01|
91492344|NCT03000439|182857099|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-1.45|1.92||||||CHAQ-Discomfort Index at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.92|-1.45|
91492345|NCT03000439|182857099|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.87|0.69||||||CHAQ-Discomfort Index at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.87|
91492346|NCT03000439|182857108|OTHER||Difference in percentage|-30.18|||||TWO_SIDED|95.0|-53.43|-6.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-6.94|-53.43|
91492347|NCT03000439|182857108|OTHER||Difference in percentage|-23.39|||||TWO_SIDED|95.0|-47.19|0.42|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||0.42|-47.19|
91492348|NCT03000439|182857108|OTHER||Difference in percentage|-0.12|||||TWO_SIDED|95.0|-23.99|23.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.76|-23.99|
91492349|NCT03000439|182857108|OTHER||Difference in percentage|6.68|||||TWO_SIDED|95.0|-17.2|30.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||30.56|-17.20|
91492350|NCT03000439|182857108|OTHER||Difference in percentage|13.13|||||TWO_SIDED|95.0|-9.92|36.19|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||36.19|-9.92|
91492351|NCT03000439|182857108|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||24.70|-24.24|
91492352|NCT03000439|182857108|OTHER||Difference in percentage|3.46|||||TWO_SIDED|95.0|-20.75|27.66|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||27.66|-20.75|
91492353|NCT03000439|182857108|OTHER||Difference in percentage|5.99|||||TWO_SIDED|95.0|-16.29|28.28|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||28.28|-16.29|
91492354|NCT03000439|182857108|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
91492355|NCT03000439|182857108|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.39|-13.88|
91492356|NCT03000439|182857108|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||44.67|-3.43|
91492357|NCT03000439|182857108|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||44.67|-3.43|
91492358|NCT03000439|182857108|OTHER||Difference in percentage|17.4|||||TWO_SIDED|95.0|-7.03|41.82|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||41.82|-7.03|
91492359|NCT03000439|182857109|OTHER||Difference in percentage|-26.61|||||TWO_SIDED|95.0|-50.42|-2.81|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-2.81|-50.42|
91492360|NCT03000439|182857109|OTHER||Difference in percentage|-20.16|||||TWO_SIDED|95.0|-43.91|3.59|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||3.59|-43.91|
91492361|NCT03000439|182857109|OTHER||Difference in percentage|-9.79|||||TWO_SIDED|95.0|-34.31|14.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||14.72|-34.31|
91492362|NCT03000439|182857109|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||24.70|-24.24|
91492363|NCT03000439|182857109|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||34.39|-13.88|
91492364|NCT03000439|182857109|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||21.68|-27.67|
91492365|NCT03000439|182857109|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||21.68|-27.67|
91730619|NCT03253627|183356129|SUPERIORITY|||||||0.253|||||||t-test, 2 sided|||3 months||||0.253
91730620|NCT03253627|183356129|SUPERIORITY|||||||0.469|||||||t-test, 2 sided|||6 months||||0.469
91492366|NCT03000439|182857109|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||16.83|-30.65|
91492367|NCT03000439|182857109|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
91492368|NCT03000439|182857109|OTHER||Difference in percentage|7.03|||||TWO_SIDED|95.0|-17.43|31.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||31.48|-17.43|
91492369|NCT03000439|182857109|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||42.52|-7.03|
91492370|NCT03000439|182857109|OTHER||Difference in percentage|14.52|||||TWO_SIDED|95.0|-10.52|39.55|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||39.55|-10.52|
91528559|NCT00600743|182932632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.2|STANDARD_ERROR_OF_MEAN|41.4||0.007|TWO_SIDED|95.0||||t test following ANOVA for difference between drug and placebo - There were 3 doses, and the value reported is for the highest and only effective dose|t-test, 2 sided|The overall error term was used to compare differences between placebo and drug||Repeated measures ANOVA||||0.007
91528560|NCT00600743|182932633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.4|STANDARD_ERROR_OF_MEAN|22.8||0.033|TWO_SIDED|95.0||||t-test after ANOVA with repeated measures on placebo minus drug (within groups) between binge and normal instructions (between groups)|t-test, 2 sided|This was part of an overall ANOVA (SAS proc mixed) with all four groups (3 doses eat normally. 4 ng dose, binge eat) and the error term had 76 df.||Each group was compared separately in an overall ANOVA with all dose groups included. The results are presented for the groups which received 4 mg dose and instructions to eat normally (normal group) or to binge eat (binge group). The test is the interaction between drug and group i.e. drug effect difference (placebo minus drug) in fullness between the group instructed to binge and the group instructed to eat normally.||||.033
91699425|NCT01542034|183293892|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.||The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||||<0.001
91730621|NCT03253627|183356130|SUPERIORITY|||||||0.628|||||||t-test, 2 sided|||baseline||||0.628
91730622|NCT03253627|183356130|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||3 months||||0.345
91492371|NCT03000439|182857109|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||42.52|-7.03|
91492372|NCT03000439|182857110|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.10|-34.29|
91492373|NCT03000439|182857110|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||4.65|-29.08|
91492374|NCT03000439|182857110|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||7.10|-25.07|
91492375|NCT03000439|182857110|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||21.23|-12.01|
91492376|NCT03000439|182857110|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||21.23|-12.01|
91528561|NCT00600743|182932634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4286|STANDARD_ERROR_OF_MEAN|13.134|<|0.014|TWO_SIDED|||||p-value is based on ANOVA with all groups and conditions and is a planned comparison|ANOVA||df = 53. 26 Used proc GLMMIX in SAS 9.4.|Tests the difference between drug and placebo for group = binge instructions||||<.014
91730623|NCT03253627|183356130|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||6 months||||0.384
91492377|NCT03000439|182857110|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||7.10|-25.07|
91492378|NCT03000439|182857110|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
91492379|NCT03000439|182857110|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
91492380|NCT03000439|182857110|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||11.87|-22.70|
91492381|NCT03000439|182857110|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
91492382|NCT03000439|182857110|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||16.48|-20.16|
91730624|NCT03253627|183356131|SUPERIORITY|||||||0.398|||||||t-test, 2 sided|||baseline||||.398
91730625|NCT03253627|183356131|SUPERIORITY|||||||0.811|||||||t-test, 2 sided|||3 months||||0.811
91730626|NCT03253627|183356131|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||6 months||||0.027
91705512|NCT01080391|183305555|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.57|0.834||Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)|Log Rank|The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).||||0.834|0.570|< 0.0001
91492383|NCT03000439|182857110|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||9.38|-26.66|
91492384|NCT03000439|182857110|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
91492385|NCT03000439|182857111|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.65|-29.08|
91492386|NCT03000439|182857111|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||5.83|-35.32|
91492387|NCT03000439|182857111|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||11.32|-27.91|
91492388|NCT03000439|182857111|OTHER||Difference in percentage|1.73|||||TWO_SIDED|95.0|-17.48|20.93|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||20.93|-17.48|
91492389|NCT03000439|182857111|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||18.91|-16.15|
91492390|NCT03000439|182857111|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||11.87|-22.70|
91492391|NCT03000439|182857111|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
91492392|NCT03000439|182857111|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
91492393|NCT03000439|182857111|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||9.38|-26.66|
91492394|NCT03000439|182857111|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
91492395|NCT03000439|182857111|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
91492396|NCT03000439|182857111|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||11.32|-27.91|
91492397|NCT03000439|182857111|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
91528562|NCT00579982|182932635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Paired t-test|t-test, 2 sided|||||||<0.001
91528563|NCT00988351|182932653|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.4|=|0.27|TWO_SIDED|95.0|-0.35|1.26||level of significance \<0.05, Power = 0.80|t-test, 2 sided|||||1.26|-.35|= 0.27
91492398|NCT03000439|182857114|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.10|-25.07|
91492399|NCT03000439|182857114|OTHER||Difference in percentage|-19.01|||||TWO_SIDED|95.0|-35.25|-2.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||-2.76|-35.25|
91492400|NCT03000439|182857114|OTHER||Difference in percentage|-15.44|||||TWO_SIDED|95.0|-32.98|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||2.10|-32.98|
91492401|NCT03000439|182857114|OTHER||Difference in percentage|-12.56|||||TWO_SIDED|95.0|-27.22|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||2.10|-27.22|
91492402|NCT03000439|182857114|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||7.10|-25.07|
91492403|NCT03000439|182857114|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||4.65|-29.08|
91492404|NCT03000439|182857114|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||9.38|-26.66|
91492405|NCT03000439|182857114|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||9.38|-26.66|
91492406|NCT03000439|182857114|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||16.48|-20.16|
91528564|NCT00988351|182932654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.65|TWO_SIDED|95.0|-1.3|2.1|||t-test, 2 sided|||Patients using PAP (average of \>=1/2 hour per night) at 6 weeks clinic visit||2.1|-1.3|= 0.65
91699426|NCT01542034|183293893|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|8.541|||<|0.001|TWO_SIDED|95.0|3.62|20.148|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||20.148|3.620|<0.001
91492407|NCT03000439|182857114|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||15.72|-25.17|
91492408|NCT03000439|182857114|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
91492409|NCT03000439|182857114|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||15.72|-25.17|
91699427|NCT01542034|183293894|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
91699428|NCT02612610|183293895|OTHER||LS Mean Difference|-0.25||||0.0971|TWO_SIDED|95.0|-0.54|0.05|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.05|-0.54|0.0971
91699429|NCT02612610|183293895|OTHER||LS Mean Difference|-0.25||||0.0928|TWO_SIDED|95.0|-0.54|0.04|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.04|-0.54|0.0928
91699430|NCT02612610|183293895|OTHER||LS Mean Difference|-0.46||||0.0027|TWO_SIDED|95.0|-0.76|-0.16|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||-0.16|-0.76|0.0027
91699431|NCT02612610|183293896|OTHER||LS Mean Difference|-0.19||||0.1914|TWO_SIDED|95.0|-0.47|0.09|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.09|-0.47|0.1914
91699432|NCT02612610|183293896|OTHER||LS Mean Difference|-0.05||||0.7099|TWO_SIDED|95.0|-0.33|0.23|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.23|-0.33|0.7099
91730627|NCT03163667|183356207|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07905|TWO_SIDED|95.0|0.34|1.2||One-sided p-value comparing the treatment groups was based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CB-839+Everolimus (CBE), and a hazard ratio \> 1 favors Placebo+Everolimus (PboE).|Stratified analysis. Stratification factors were Memorial Sloan Kettering Cancer Center (MSKCC) Prognostic Risk (favorable versus intermediate/poor risk) and number of prior therapies with a tyrosine kinase inhibitor (TKI; 1 versus \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.20|0.34|0.07905
91730628|NCT03163667|183356207|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1184|TWO_SIDED|95.0|0.37|1.28||One-sided p-value comparing the treatment groups was based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.28|0.37|0.1184
91730629|NCT03163667|183356208|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4801|TWO_SIDED|95.0|0.42|1.5||P-value comparing the treatment groups is based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Stratified analysis: Stratification factors are MSKCC Prognostic Risk (favorable vs intermediate/poor risk) and number of prior therapies with a TKI (1 vs \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.50|0.42|0.4801
91492410|NCT03000439|182857114|OTHER||Difference in percentage|2.07|||||TWO_SIDED|95.0|-18.53|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||22.68|-18.53|
91492411|NCT01749137|182857118|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.059|TWO_SIDED|95.0|-2.27|0.04|||Mixed Model Repeated Measures (MMRM)|||||0.04|-2.27|0.059
91492412|NCT01749137|182857119|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.66||0.079|TWO_SIDED|95.0|-2.48|0.14|||MMRM|||||0.14|-2.48|0.079
91699433|NCT02612610|183293896|OTHER||LS Mean Difference|-0.52||||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.24|-0.80|0.0003
91699434|NCT02612610|183293897|OTHER||LS Mean Difference|-0.4||||0.0099|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.10|-0.71|0.0099
91699435|NCT02612610|183293897|OTHER||LS Mean Difference|-0.28||||0.0695|TWO_SIDED|95.0|-0.58|0.02|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.02|-0.58|0.0695
91699436|NCT02612610|183293897|OTHER||LS Mean Difference|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.31|-0.93|0.0001
91699437|NCT02612610|183293898|OTHER||LS Mean Difference|-0.24||||0.0991|TWO_SIDED|95.0|-0.52|0.04|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.04|-0.52|0.0991
91699438|NCT02612610|183293898|OTHER||LS Mean Difference|-0.25||||0.0811|TWO_SIDED|95.0|-0.53|0.03|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.03|-0.53|0.0811
91699439|NCT02612610|183293898|OTHER||LS Mean Difference|-0.47||||0.0014|TWO_SIDED|95.0|-0.76|-0.19|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.19|-0.76|0.0014
91699440|NCT02612610|183293899|OTHER||LS Mean Difference|-0.21||||0.1468|TWO_SIDED|95.0|-0.5|0.07|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. ."||0.07|-0.50|0.1468
91699441|NCT02612610|183293899|OTHER||LS Mean Difference|-0.08||||0.5874|TWO_SIDED|95.0|-0.36|0.2|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.20|-0.36|0.5874
91699442|NCT02612610|183293899|OTHER||LS Mean Difference|-0.49||||0.0008|TWO_SIDED|95.0|-0.78|-0.21|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.21|-0.78|0.0008
91699443|NCT02612610|183293900|OTHER||Mixed Effect Repeated Measures model|-0.39||||0.0177|TWO_SIDED|95.0|-0.7|-0.07|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.07|-0.70|0.0177
91730630|NCT03163667|183356208|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5603|TWO_SIDED|95.0|0.44|1.56||P-value comparing the treatment groups is based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.56|0.44|0.5603
91492413|NCT01749137|182857120|SUPERIORITY|||||||0.513||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site and the stratification factor severely obese (yes/no).|Cochran-Mantel-Haenszel|||||||0.513
91528565|NCT00988351|182932655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.71|=|0.33|TWO_SIDED|95.0|-0.73|2.1||\< 0.05 criteria for statistical significance|t-test, 2 sided|||Patients using PAP (average \>=1/2 hour per nightly use) at 6 weeks clinic visit||2.1|-0.73|=0.33
91699444|NCT02612610|183293900|OTHER||LS Mean Difference|-0.32||||0.0498|TWO_SIDED|95.0|-0.63|0.0|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.00|-0.63|0.0498
91492414|NCT01749137|182857128|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.87||0.387|TWO_SIDED|95.0|-2.5|0.98|||MMRM|||||0.98|-2.50|0.387
91699445|NCT02612610|183293900|OTHER||LS Mean Difference|-0.59||||0.0004|TWO_SIDED|95.0|-0.92|-0.27|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.27|-0.92|0.0004
91699446|NCT02612610|183293902|OTHER||LS Mean Difference|-6.4||||0.1318|TWO_SIDED|95.0|-14.8|1.9|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-14.8|0.1318
91699447|NCT02612610|183293902|OTHER||LS Mean Difference|-2.9||||0.4917|TWO_SIDED|95.0|-11.3|5.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.4|-11.3|0.4917
91699448|NCT02612610|183293902|OTHER||LS Mean Difference|-9.8||||0.0228|TWO_SIDED|95.0|-18.2|-1.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.4|-18.2|0.0228
91699449|NCT02612610|183293903|OTHER||LS Mean Difference|-2.6||||0.554|TWO_SIDED|95.0|-11.5|6.2|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||6.2|-11.5|0.5540
91699450|NCT02612610|183293903|OTHER||LS Mean Difference|-3.2||||0.4702|TWO_SIDED|95.0|-12.0|5.6|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.6|-12.0|0.4702
91730631|NCT00855166|183356227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3885|<|0.0001|TWO_SIDED|95.0|-2.84|-1.31||Significant at alpha=0.05 (2-sided)|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.31|-2.84|<0.0001
91730632|NCT00855166|183356228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.6162||0.0143|TWO_SIDED|95.0|-2.74|-0.31||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.31|-2.74|0.0143
91699451|NCT02612610|183293903|OTHER||LS Mean Difference|-10.7||||0.0197|TWO_SIDED|95.0|-19.8|-1.7|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.7|-19.8|0.0197
91699452|NCT02612610|183293904|OTHER||LS Mean Difference|-4.4||||0.302|TWO_SIDED|95.0|-12.9|4.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.0|-12.9|0.3020
91699453|NCT02612610|183293904|OTHER||LS Mean Difference|-6.4||||0.1365|TWO_SIDED|95.0|-14.8|2.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.0|-14.8|0.1365
91699454|NCT02612610|183293904|OTHER||LS Mean Difference|-11.2||||0.0108|TWO_SIDED|95.0|-19.7|-2.6|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-2.6|-19.7|0.0108
91492415|NCT01749137|182857129|SUPERIORITY|||||||1||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site.|Cochran-Mantel-Haenszel|||||||1.000
91730633|NCT00855166|183356229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.3731||0.0001|TWO_SIDED|95.0|-2.22|-0.74||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.74|-2.22|0.0001
91528566|NCT00988351|182932656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||=|0.49|TWO_SIDED|95.0|-1.12|2.29|||t-test, 2 sided|||Patients using PAP (average \>= 1/2 hour of nightly use) at 6 weeks clinic visit||2.29|-1.12|=0.49
91730634|NCT00855166|183356230|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.3|STANDARD_ERROR_OF_MEAN|5.309|<|0.0001|TWO_SIDED|95.0|15.9|36.7||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender).||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||36.7|15.9|<0.0001
91513263|NCT02710630|182898020|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|56.71|STANDARD_DEVIATION|74.2|||TWO_SIDED|90.0|43.388|74.122|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||74.122|43.388|
91492416|NCT03130257|182857140|EQUIVALENCE|The study planned for a sample size of 510 and 80% protocol completion, resulting in sample size 136 per group. With this sample size, the least detectable difference (LDD) is 4.1 mmHg systolic BP (SBP) and 2.8 mmHg diastolic BP (DBP) between any two groups (assuming Standard Deviation 12.1 and 8.3 for SBP and DBP respectively). Actual sample sizes completing protocol were 142, 149, and 111 for Clinic, Home, and Kiosk groups respectively, resulting in LDD of at least 4.3 for SBP and 3.0 for DBP.|||||<|0.05|||||||Regression, Linear|||We used linear regression models to estimate the mean difference in BP between diagnostic measurement and daytime average 24-hr BP for each randomization group. Models were estimated using generalized estimating equations with robust standard errors, and adjusted for age, sex, BMI, education, and baseline systolic and diastolic BP. Separate models estimated mean differences (diagnostic protocol - 24-hr BP) between groups for systolic and diastolic BP.||||<0.05
91492417|NCT02064894|182857143|SUPERIORITY_OR_OTHER|||||||0.81|||||||Cochran-Mantel-Haenszel|||||||0.81
91492418|NCT01976338|182857145|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91492419|NCT01112865|182857169|SUPERIORITY_OR_OTHER|||||||0.6858|TWO_SIDED|||||Binomial test against the null hypothesis|binomial test|||Null hypothesis: percentage of participants preferring Genotropin Mark VII injection pen = 50%||||0.6858
91492420|NCT02197247|182857172|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% confidence intervals (CIs) for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric least-squares (LS) mean ratio|27.16|||||TWO_SIDED|90.0|24.36|30.29|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed Css,max values were compared between periods using a mixed effects analysis of variance (ANOVA) with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both area under the plasma concentration-time curve during the dosing interval (AUCtau) and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||30.29|24.36|
91492421|NCT02197247|182857173|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% CIs for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric LS Mean Ratio|21.55|||||TWO_SIDED|90.0|19.5|23.83|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both AUCtau and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||23.83|19.50|
91492422|NCT02197247|182857174|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.53|||||TWO_SIDED|90.0|85.27|107.03|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||107.03|85.27|
91759154|NCT04038567|183411362|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|95.0|-2.12|-0.16||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.16|-2.12|
91492423|NCT02197247|182857175|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|21.72|||||TWO_SIDED|90.0|19.08|24.72|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||24.72|19.08|
91492424|NCT02197247|182857175|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|88.31|||||TWO_SIDED|90.0|77.17|101.07|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||101.07|77.17|
91492425|NCT02197247|182857176|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|139.32|||||TWO_SIDED|90.0|127.74|151.96|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||151.96|127.74|
91492426|NCT02197247|182857176|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.75|||||TWO_SIDED|90.0|92.04|110.29|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.29|92.04|
91492427|NCT02197247|182857178|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.89|||||TWO_SIDED|90.0|86.37|106.45|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||106.45|86.37|
91492428|NCT02197247|182857179|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|18.76|||||TWO_SIDED|90.0|16.61|21.19|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||21.19|16.61|
91513264|NCT02710630|182898020|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.99|STANDARD_DEVIATION|52.8|||TWO_SIDED|90.0|87.554|130.732|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||130.732|87.554|
91699455|NCT02612610|183293905|OTHER||LS Mean Difference|-4.0||||0.3509|TWO_SIDED|95.0|-12.3|4.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.4|-12.3|0.3509
91699456|NCT02612610|183293905|OTHER||LS Mean Difference|-8.2||||0.0519|TWO_SIDED|95.0|-16.6|0.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-16.6|0.0519
91699457|NCT02612610|183293905|OTHER||LS Mean Difference|-15.9||||0.0003|TWO_SIDED|95.0|-24.3|-7.5|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-7.5|-24.3|0.0003
91730635|NCT00855166|183356231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.5652||0.7013|TWO_SIDED|95.0|-0.89|1.34||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||1.34|-0.89|0.7013
91730636|NCT00855166|183356232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.6473||0.1521|TWO_SIDED|95.0|-2.21|0.35||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.35|-2.21|0.1521
91730637|NCT00855166|183356233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.4428||0.3105|TWO_SIDED|95.0|-1.32|0.43||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.43|-1.32|0.3105
91730638|NCT03769116|183356242|OTHER||Hodges-Lehmann treatment diff|6.11|||<|0.0001|TWO_SIDED|95.0|2.08|12.58|||Wilcoxon rank sum test|||Analysis conducted on changes from baseline.||12.58|2.08|< 0.0001
91730639|NCT03769116|183356243|OTHER||LSM Change Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9|=|0.373|TWO_SIDED|95.0|-1.0|2.7|||Mixed-model for Repeated Measures|||||2.7|-1.0|= 0.3730
91730640|NCT03769116|183356251|OTHER||LSM Change Difference|2.5|STANDARD_ERROR_OF_MEAN|0.9|=|0.0172|TWO_SIDED|95.0|0.5|4.4|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 4-5 years old||4.4|0.5|= 0.0172
91730641|NCT03769116|183356251|OTHER||LSM Change Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1|=|0.5384|TWO_SIDED|95.0|-3.0|1.6|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 6-7 years old||1.6|-3.0|= 0.5384
91730642|NCT02214212|183356270|SUPERIORITY||Slope|-0.16||||0.955|TWO_SIDED|95.0|-5.69|5.37|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.|The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||5.37|-5.69|.955
91492429|NCT02197247|182857179|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|90.08|||||TWO_SIDED|90.0|79.34|102.27|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||102.27|79.34|
91730643|NCT02214212|183356271|SUPERIORITY||Mean Difference (Net)|0.69||||0.807|TWO_SIDED|95.0|-4.9|6.29|||Mixed Models Analysis|||||6.29|-4.90|.807
91730644|NCT02214212|183356272|SUPERIORITY||Mean Difference (Net)|-0.48||||0.847|TWO_SIDED|95.0|-5.38|4.43|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.||||4.43|-5.38|.847
91730645|NCT02214212|183356273|SUPERIORITY||Mean Difference (Net)|3.14||||0.252|TWO_SIDED|95.0|-2.29|8.56|||Mixed Models Analysis|Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.||||8.56|-2.29|.252
91730646|NCT02214212|183356274|SUPERIORITY||Mean Difference (Net)|0.67||||0.722|TWO_SIDED|95.0|-3.08|4.4|||Mixed Models Analysis|||||4.4|-3.08|.722
91730647|NCT02214212|183356275|SUPERIORITY||Mean Difference (Net)|-2.25||||0.253|TWO_SIDED|95.0|-6.13|1.64|||Mixed Models Analysis|||||1.64|-6.13|.253
91730648|NCT02214212|183356276|SUPERIORITY||Mean Difference (Net)|-0.39||||0.351|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.|A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.|||0.44|-1.21|.351
91730649|NCT02214212|183356277|SUPERIORITY||Slope|0.0||||0.91|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects|The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||0.03|-0.03|.910
91730650|NCT02214212|183356278|SUPERIORITY||Mean Difference (Net)|0.857||||0.19|TWO_SIDED|95.0|-1.93|2.32|||Mixed Models Analysis|Mixed-effects model adjusts for treatment time (pre/post)||||2.32|-1.93|0.19
91730651|NCT02214212|183356279|SUPERIORITY||Mean Difference (Net)|-4.8||||0.345|TWO_SIDED|95.0|-14.83|5.24|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.||||5.24|-14.83|.345
91730652|NCT04903093|183356281|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|96.96|||||TWO_SIDED|90.0|85.43|110.03||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||110.03|85.43|
91730653|NCT04903093|183356281|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio (%) of adjusted geometric means|62.87|||||TWO_SIDED|90.0|54.85|72.07||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet||72.07|54.85|
91730654|NCT04903093|183356282|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|100.07|||||TWO_SIDED|90.0|80.28|124.74||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||124.74|80.28|
91730655|NCT04903093|183356282|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|15.53|||||TWO_SIDED|90.0|12.46|19.36||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet; Reference: Abrocitinib 200 mg commercial tablet||19.36|12.46|
91730656|NCT03657407|183356302|SUPERIORITY||Mean Difference (Final Values)|-0.65||||0.17|TWO_SIDED|95.0|-0.71|2.0|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||2.0|-0.71|0.17
91730657|NCT03657407|183356303|SUPERIORITY||Mean Difference (Final Values)|-2.02||||0.29|TWO_SIDED|95.0|-5.4|9.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||9.5|-5.4|0.29
91730658|NCT03657407|183356304|SUPERIORITY||Median Difference (Final Values)|-19.31||||0.05|TWO_SIDED|95.0|-43.1|4.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||4.5|-43.1|0.05
91492430|NCT02197247|182857180|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|129.81|||||TWO_SIDED|90.0|119.14|141.44|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||141.44|119.14|
91492431|NCT02197247|182857180|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.76|||||TWO_SIDED|90.0|92.15|110.19|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.19|92.15|
91492432|NCT01606007|182857190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.1112|<|0.0001|TWO_SIDED|95.0|-0.81|-0.37||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.37|-0.81|<0.0001
91492433|NCT01606007|182857190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1108||0.0166|TWO_SIDED|95.0|-0.48|-0.05||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.05|-0.48|0.0166
91492434|NCT01606007|182857191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|STANDARD_ERROR_OF_MEAN|4.914|<|0.0001|TWO_SIDED|95.0|-53.7|-34.3||Each secondary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|ANCOVA|||LOCF||-34.3|-53.7|<0.0001
91730659|NCT03657407|183356305|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.42|TWO_SIDED|95.0|0.42|1.7|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||1.7|0.42|0.42
91730660|NCT03926247|183356311|OTHER|Within-group longitudinal analysis (no comparison groups)|LSM Final Difference|-0.044|STANDARD_ERROR_OF_MEAN|0.019|=|0.019|TWO_SIDED|95.0|-0.087|-0.008|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' depression/anxiety symptoms would decrease overtime.||-0.008|-0.087|=0.019
91730661|NCT03926247|183356312|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.643|=|0.168|TWO_SIDED|95.0|-2.161|0.372|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' PTSD symptoms would decrease overtime.||0.372|-2.161|=0.168
91730662|NCT03926247|183356313|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.035|=|0.051|TWO_SIDED|95.0|-0.14|0.0|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' stress would decrease overtime.||-0.000|-0.140|=0.051
91730663|NCT03926247|183356314|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.029|=|0.211|TWO_SIDED|95.0|-0.106|0.023|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' social support would increase overtime.||0.023|-0.106|=0.211
91730664|NCT03926247|183356315|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.053|=|0.074|TWO_SIDED|95.0|-0.008|0.201|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' access to resources would increase overtime.||0.201|-0.008|=0.074
91730665|NCT03926247|183356316|OTHER|Within-group longitudinal analysis (no comparison groups)=|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.061|=|0.089|TWO_SIDED|95.0|-0.257|0.017|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' difficulty accessing resources would decrease overtime.||0.017|-0.257|=0.089
91730666|NCT03926247|183356317|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.216|STANDARD_ERROR_OF_MEAN|0.124|=|0.086|TWO_SIDED|95.0|-0.461|0.03|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' quality of life would increase overtime.||0.030|-0.461|=0.086
91730667|NCT05226884|183356318|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
91730668|NCT05226884|183356319|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
91730669|NCT05226884|183356320|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
91730670|NCT05226884|183356321|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||||||||||||||The defocus curve is generated based on measurements over a dioptric range.|||
91730671|NCT05226884|183356322|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
91730672|NCT01539525|183356360|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.118|-0.038|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the linear effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.038|-0.118|<0.001
91730673|NCT01539525|183356360|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.066|TWO_SIDED|95.0|-0.0004|0.011|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the quadratic effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.011|-0.0004|0.066
91492435|NCT01606007|182857191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|4.923||0.0639|TWO_SIDED|95.0|-18.8|0.5||Each secondary endpoint was tested at alpha=0.05; significance testing stops at the endpoint where p-value\>0.05.|ANCOVA|||LOCF||0.5|-18.8|0.0639
91492436|NCT01606007|182857192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|3.988|||TWO_SIDED|95.0|-31.6|-15.9|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-15.9|-31.6|
91492437|NCT01606007|182857192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.957|||TWO_SIDED|95.0|-13.8|1.7|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||1.7|-13.8|
91492438|NCT01606007|182857193|SUPERIORITY_OR_OTHER||Mean difference in percentages|23.1|STANDARD_ERROR_OF_MEAN|4.282|||TWO_SIDED|95.0|14.7|31.5|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||31.5|14.7|
91730674|NCT01539525|183356360|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.034||0.038|TWO_SIDED|95.0|-0.151|-0.004||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.004|-0.151|0.038
91730675|NCT01539525|183356360|SUPERIORITY_OR_OTHER||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.034||0.008|TWO_SIDED|95.0|-0.157|-0.023||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.023|-0.157|0.008
91492439|NCT01606007|182857193|SUPERIORITY_OR_OTHER||Mean difference in percentages|19.1|STANDARD_ERROR_OF_MEAN|4.587|||TWO_SIDED|95.0|10.1|28.1|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||28.1|10.1|
91492440|NCT01606007|182857194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|0.3451|||TWO_SIDED|95.0|-2.73|-1.37|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-1.37|-2.73|
91492441|NCT02499783|182857211|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7|||Cochran-Mantel-Haenszel|Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Risk difference = (adalimumab 160/80 mg - placebo). Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|||41.7|19.2|<0.001
91492442|NCT02499783|182857212|SUPERIORITY||Risk Difference Compared to 30%|34.6|||<|0.001|TWO_SIDED|95.0|26.2|42.4|||One Sample Exact Test|The one sample Exact test was performed by comparing it to the clinically meaningful remission rate of 30%.||||42.4|26.2|< 0.001
91492443|NCT02499783|182857213|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||43.6|23.2|< 0.001
91492444|NCT02499783|182857217|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||54.2|26.7|< 0.001
91492445|NCT02499783|182857218|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||63.5|36.9|< 0.001
91699458|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1387|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1387
91699459|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7238|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7238
91699460|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0144|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0144
91699461|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0922|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0922
91730676|NCT01539525|183356360|SUPERIORITY_OR_OTHER||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.005||0.031|TWO_SIDED|95.0|0.001|0.022||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.022|0.001|0.031
91492446|NCT02499783|182857219|SUPERIORITY||Adjusted Risk Difference|27.6|||<|0.001|TWO_SIDED|95.0|18.2|37.0||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||37.0|18.2|< 0.001
91492447|NCT02499783|182857221|SUPERIORITY||Adjusted Risk Difference|19.6||||0.002|TWO_SIDED|95.0|7.1|32.1||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||32.1|7.1|0.002
91730677|NCT01539525|183356360|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.0005||0.01|TWO_SIDED|95.0|0.002|0.021||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.021|0.002|0.010
91730678|NCT01539525|183356361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.81|TWO_SIDED|95.0|0.559|1.551|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual|||1.551|0.559|0.810
91730679|NCT01539525|183356361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.99|TWO_SIDED|95.0|0.579|1.617|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual|||1.617|0.579|0.990
91730680|NCT01539525|183356362|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.258||||0.465|TWO_SIDED|95.0|0.409|3.871|||Regression, Logistic|adjusted for stratifying variables- primary drug and pregnancy status|odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual|||3.871|0.409|0.465
91730681|NCT01539525|183356362|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.749||||0.49|TWO_SIDED|95.0|0.205|2.732|||Regression, Logistic||Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual|||2.732|0.205|0.490
91730682|NCT02691494|183356373|SUPERIORITY||Odds Ratio (OR)|28.73|||<|0.001|TWO_SIDED|95.0|12.248|67.387||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||67.387|12.248|< 0.001
91730683|NCT02691494|183356373|SUPERIORITY||Odds Ratio (OR)|28.31|||<|0.001|TWO_SIDED|95.0|13.042|61.431||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||61.431|13.042|< 0.001
91730684|NCT02691494|183356374|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|21.7|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
91730685|NCT02691494|183356374|SUPERIORITY||LS Mean of Difference|-164.6|STANDARD_ERROR_OF_MEAN|18.87|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
91730686|NCT02691494|183356375|SUPERIORITY||Between-Group Difference (%)|84.2|||<|0.001|TWO_SIDED|95.0|75.99|92.37||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||92.37|75.99|< 0.001
91730687|NCT02691494|183356375|SUPERIORITY||Between-Group Difference (%)|56.3|||<|0.001|TWO_SIDED|95.0|47.77|64.91||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||64.91|47.77|< 0.001
91730688|NCT02691494|183356376|SUPERIORITY||LS Mean of Difference|-252.3|STANDARD_ERROR_OF_MEAN|24.53|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91730689|NCT02691494|183356376|SUPERIORITY||LS Mean of Difference|-226.6|STANDARD_ERROR_OF_MEAN|20.5|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91730690|NCT02691494|183356377|SUPERIORITY||LS Mean of Difference|-196.9|STANDARD_ERROR_OF_MEAN|16.66|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91730691|NCT02691494|183356377|SUPERIORITY||LS Mean of Difference|-186.1|STANDARD_ERROR_OF_MEAN|14.18|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91730692|NCT02691494|183356378|SUPERIORITY||Between-Group Difference (%)|19.2||||0.146|TWO_SIDED|95.0|-5.99|44.32||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||44.32|-5.99|0.146
91730693|NCT02691494|183356378|SUPERIORITY||Between-Group Difference (%)|29.2||||0.017|TWO_SIDED|95.0|7.62|50.71||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||50.71|7.62|0.017
91730694|NCT02691494|183356379|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|20.56|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91730695|NCT02691494|183356379|SUPERIORITY||LS Mean of Difference|-125.0|STANDARD_ERROR_OF_MEAN|17.55|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
91730696|NCT01694771|183356397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.144|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.144|0.090|<0.0001
91730697|NCT01694771|183356398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.088|0.037|<0.0001
91730698|NCT01694771|183356399|SUPERIORITY_OR_OTHER||Mean change from baseline|0.119|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.147|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.147|0.090|<0.0001
91730699|NCT01694771|183356400|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.146|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.192|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.192|0.100|<0.0001
91730700|NCT01694771|183356401|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.063|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.019|0.106|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.106|0.019|0.0047
91730701|NCT01694771|183356402|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.106|0.201|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.201|0.106|<0.0001
91730702|NCT01694771|183356403|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|8.459|STANDARD_ERROR_OF_MEAN|2.192||0.0001|TWO_SIDED|95.0|4.159|12.759|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||12.759|4.159|0.0001
91492448|NCT02499783|182857223|SUPERIORITY||Least Squares Mean Difference|-385.2|||<|0.001|TWO_SIDED|95.0|-598.81|-171.5||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||||-171.50|-598.81|< 0.001
91492449|NCT02499783|182857224|SUPERIORITY||Adjusted Risk Difference|9.8||||0.001|TWO_SIDED|95.0|3.9|15.8||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||15.8|3.9|0.001
91730703|NCT01694771|183356404|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.478|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.706|-0.25|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.250|-0.706|<.0001
91492450|NCT02499783|182857226|SUPERIORITY||Adjusted Risk Difference|18.4|||<|0.001|TWO_SIDED|95.0|8.2|28.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 2||28.6|8.2|< 0.001
91492451|NCT02499783|182857226|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 4||41.7|19.2|< 0.001
91528567|NCT00988351|182932657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.51|=|0.07|TWO_SIDED|95.0|-1.92|0.09||P \< 0.05 considered statistically significant|t-test, 2 sided|||participants using PAP (average \>=1/2 hour of use) at 6 weeks clinic visit||0.09|-1.92|=0.07
91528568|NCT01304082|182932751|SUPERIORITY_OR_OTHER|||||||0.7535||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||0.7535
91528569|NCT01304082|182932752|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
91730704|NCT01694771|183356405|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.083|STANDARD_ERROR_OF_MEAN|0.041||0.0442|TWO_SIDED|95.0|-0.164|-0.002|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.002|-0.164|0.0442
91730705|NCT01694771|183356406|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.393|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001|TWO_SIDED|95.0|-0.586|-0.2|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.200|-0.586|<.0001
91492452|NCT02499783|182857228|SUPERIORITY||Adjusted Risk Difference|21.4|||<|0.001|TWO_SIDED|95.0|12.6|30.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2||30.2|12.6|< 0.001
91492453|NCT02499783|182857228|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4||43.6|23.2|< 0.001
91492454|NCT02499783|182857230|SUPERIORITY||Adjusted Risk Difference|21.7||||0.001|TWO_SIDED|95.0|8.7|34.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2||34.6|8.7|0.001
91492455|NCT02499783|182857230|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4||54.2|26.7|< 0.001
91492456|NCT02499783|182857232|SUPERIORITY||Adjusted Risk Difference|31.4|||<|0.001|TWO_SIDED|95.0|19.6|43.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2||43.2|19.6|< 0.001
91528570|NCT01304082|182932753|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
91730706|NCT03759379|183356464|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|2.44|<|1e-07|TWO_SIDED|95.0|-21.78|-12.22||P=3.542E-12|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset) and continuous covariate (baseline value).||-12.22|-21.78|<0.0000001
91492457|NCT02499783|182857232|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4||63.5|36.9|< 0.001
91492458|NCT02499783|182857234|SUPERIORITY||Least Squares Mean Difference|-43.34|||<|0.001|TWO_SIDED|95.0|-59.39|-27.3||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 2||-27.30|-59.39|< 0.001
91492459|NCT02499783|182857234|SUPERIORITY||Least Squares Mean Difference|-66.63|||<|0.001|TWO_SIDED|95.0|-84.2|-49.06||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 4||-49.06|-84.20|< 0.001
91492460|NCT02499783|182857236|SUPERIORITY||Least Squares Mean Difference|-13.921|||<|0.001|TWO_SIDED|95.0|-19.183|-8.659||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 2||-8.659|-19.183|< 0.001
91513265|NCT02710630|182898020|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.07|STANDARD_DEVIATION|40.7|||TWO_SIDED|90.0|91.399|125.432|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||125.432|91.399|
91513266|NCT02710630|182898021|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.39|STANDARD_DEVIATION|45.3|||TWO_SIDED|90.0|96.74|137.644|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.644|96.740|
91730707|NCT03759379|183356465|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-16.2|STANDARD_ERROR_OF_MEAN|2.8|<|1e-07|TWO_SIDED|95.0|-21.7|-10.8||P=5.426E-09|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset baseline NIS) and continuous covariate (baseline value).||-10.8|-21.7|<0.0000001
91492461|NCT02499783|182857236|SUPERIORITY||Least Squares Mean Difference|-16.844|||<|0.001|TWO_SIDED|95.0|-21.206|-12.483||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 4||-12.483|-21.206|< 0.001
91730708|NCT03759379|183356466|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|0.131|STANDARD_ERROR_OF_MEAN|0.031|<|1e-07|TWO_SIDED|95.0|0.07|0.193||P=3.103E-05|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset, baseline NIS) and continuous covariate (baseline value).||0.193|0.070|<0.0000001
91730709|NCT04924608|183356473|SUPERIORITY|||||||0.0112|||||||Fisher Exact|The ORR will be compared at the end of Cycle 16 between selumetinib vs placebo with the 2-sided significance level 0.047.||||||0.0112
91730710|NCT04924608|183356474|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.07|TWO_SIDED|95.0|-1.6|0.1|||Mixed Models Analysis|Analysis is based on a MMRM model for repeated measures, Kenward-Roger method is used to estimate the degrees of freedom.||||0.1|-1.6|0.070
91492462|NCT02228460|182857239|OTHER|||||||0.3173||||||Threshold for significance at 0.05 level.|McNemar Test|||A McNemar test was used to test the treatment effect based on paired pre-treatment and post-treatment (Week 26) frequencies of skin GL-3 score grouped into the categories (0 to \<2; 2 to 3).||||0.3173
91492463|NCT02228460|182857240|OTHER|||||||0.625||||||Threshold for significance at 0.05 level.|Wilcoxon signed rank test|||Wilcoxon signed rank test was used to assess the mean change from Baseline to Week 26 in skin GL-3 score.||||0.625
91492464|NCT01010061|182857279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.28||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.28|0.16|<0.0001
91730711|NCT04924608|183356475|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.024|TWO_SIDED|95.0|-1.3|-0.1||nominal|Mixed Models Analysis|Analysis is based on a MMRM model for repeated measures, Kenward-Roger method is used to estimate the degrees of freedom.||supplementary analysis is not controlled for multiplicity.||-0.1|-1.3|0.024
91730712|NCT04924608|183356476|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.918|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Analysis is based on a MMRM model for repeated measures, Kenward-Roger method is used to estimate the degrees of freedom.||||1.1|-1.2|0.918
91730713|NCT03727022|183356505|SUPERIORITY||Mean Difference (Final Values)|-2.81|||||TWO_SIDED|95.0|-7.19|1.58||||||||1.58|-7.19|
91492465|NCT01010061|182857281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.14|0.27|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.27|0.14|<0.0001
91730714|NCT03727022|183356506|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-3.24|3.24||||||||3.24|-3.24|
91730715|NCT03727022|183356507|SUPERIORITY||Mean Difference (Final Values)|-2.09|||||TWO_SIDED|95.0|-5.84|1.65||||||||1.65|-5.84|
91730716|NCT03727022|183356508|SUPERIORITY||Median Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-4.05|3.54||||||||3.54|-4.05|
91730717|NCT03727022|183356509|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-4.64|6.23||||||||6.23|-4.64|
91730718|NCT03727022|183356510|SUPERIORITY||Mean Difference (Final Values)|-3.2|||||TWO_SIDED|95.0|-8.64|2.23||||||||2.23|-8.64|
91730719|NCT03727022|183356511|SUPERIORITY||Mean Difference (Final Values)|-2.36|||||TWO_SIDED|95.0|-8.75|4.03||||||||4.03|-8.75|
91730720|NCT03727022|183356512|SUPERIORITY||Median Difference (Final Values)|-4.05|||||TWO_SIDED|95.0|-11.21|3.11||||||||3.11|-11.21|
91730721|NCT03031912|183356540|SUPERIORITY||Fold difference|42.9|||<|0.001|TWO_SIDED|95.0|31.49|58.43|||ANOVA|||V920 vs. placebo in Cohorts 1 to 5 combined||58.43|31.49|<0.001
91730722|NCT03031912|183356541|SUPERIORITY||Fold difference|208.66|||<|0.001|TWO_SIDED|95.0|115.57|376.72|||ANOVA|||||376.72|115.57|<0.001
91492466|NCT01010061|182857284|SUPERIORITY||Difference in Response Rates|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||55.5|34.7|< 0.0001
91492467|NCT01010061|182857285|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.26|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.26|0.15|<0.0001
91492468|NCT01010061|182857286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0196|TWO_SIDED|95.0|0.49|0.94|||Log Rank, Stratified|||||0.94|0.49|0.0196
91492469|NCT01010061|182857287|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.28|0.13|<0.0001
91492470|NCT01010061|182857289|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.35|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.35|0.19|<0.0001
91492471|NCT03066804|182857293|SUPERIORITY||Geometric Mean Ratio|0.8362|||<|0.0001|TWO_SIDED|95.0|0.7987|0.8754|||Mixed Models Analysis|||Week 12||0.8754|0.7987|<0.0001
91730723|NCT04097743|183356578|SUPERIORITY||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|4.36||0.41|TWO_SIDED||||||ANOVA|||||||0.41
91730724|NCT04097743|183356579|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|4.41||0.81|TWO_SIDED||||||ANOVA|||||||0.81
91730725|NCT04097743|183356580|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.47||0.39|TWO_SIDED||||||ANOVA|||||||0.39
91730726|NCT04097743|183356581|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.47||0.67|TWO_SIDED||||||ANOVA|||||||0.67
91492472|NCT03066804|182857294|SUPERIORITY||Mean Difference (Net)|-2.4985||||0.4164|TWO_SIDED|95.0|-8.5267|3.52297|||Mixed Models Analysis|||||3.52297|-8.5267|0.4164
91492473|NCT03066804|182857295|SUPERIORITY||Mean Difference (Net)|0.5231||||0.4791|TWO_SIDED|95.0|-0.9258|1.972|||Mixed Models Analysis|||||1.9720|-0.9258|0.4791
91492474|NCT03066804|182857296|SUPERIORITY||Odds Ratio (OR)|0.8993||||0.5294|TWO_SIDED|95.0|0.6461|1.2518|||longitudinal binary logistic regression|||||1.2518|0.6461|0.5294
91730727|NCT04097743|183356582|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.47||0.99|TWO_SIDED||||||ANOVA|||||||0.99
91730728|NCT04097743|183356583|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|1.49||0.49|TWO_SIDED||||||ANOVA|||||||0.49
91730729|NCT04097743|183356584|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|1.36||0.67|TWO_SIDED||||||ANOVA|||||||0.67
91730730|NCT04097743|183356585|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|1.37||0.89|TWO_SIDED||||||ANOVA|||||||0.89
91730731|NCT04097743|183356586|SUPERIORITY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|0.9||0.08|TWO_SIDED||||||ANOVA|||||||0.08
91730732|NCT04975230|183356618|OTHER||Cohen's D|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.0227|TWO_SIDED|95.0|-0.37|0.78|||Mixed Models Analysis|||||0.78|-0.37|0.0227
91730733|NCT05562934|183356638|SUPERIORITY|||||||0.5651||||||Single best candidate model is the one with the lowest adjusted p-value of the 5 candidate models|Multiple Comparisons Procedure-MOD|||||||0.5651
91730734|NCT05562934|183356639|SUPERIORITY||Median Difference (Net)|1.37||||0.6955|TWO_SIDED|95.0|-5.48|8.21|||ANCOVA|||||8.21|-5.48|0.6955
91730735|NCT05562934|183356640|SUPERIORITY||Median Difference (Net)|1.14||||0.7108|TWO_SIDED|95.0|-4.9|7.18|||ANCOVA|||||7.18|-4.90|0.7108
91730736|NCT06547814|183356655|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.79|1.35|||||The Standard implementation arm was the reference group.|||1.35|0.79|
91730737|NCT03997383|183356656|SUPERIORITY||Median Difference (Net)|14.693||||0.0162|TWO_SIDED|95.0|0.693|28.692||P-value was determined by the Wilcoxon Rank Sum test,stratified by baseline tafamidis use.Analysis was performed on the 100 multiply-imputed datasets.|Wilcoxon Rank Sum Test||Median difference estimated by the Hodges-Lehmann method, stratified by baseline tafamidis use. Analysis was performed on the 100 multiply-imputed datasets.|||28.692|0.693|0.0162
91730738|NCT03997383|183356657|SUPERIORITY||Least squares (LS) mean difference|3.709|STANDARD_ERROR_OF_MEAN|1.796||0.0397|TWO_SIDED|95.0|0.176|7.242||P-value was analyzed using mixed model repeated measures (MMRM) as described in the Statistical analysis plan.|MMRM|||||7.242|0.176|0.0397
91730739|NCT03997383|183356658|SUPERIORITY||Stratified Win Ratio|1.27||||0.0574|TWO_SIDED|95.0|0.99|1.61|||Z-test|P-value was analyzed by a z-test using the mean and variance of the log-transformed win ratio estimate.||||1.61|0.99|0.0574
91730740|NCT03997383|183356659|SUPERIORITY||Hazard Ratio (HR)|0.997||||0.9888|TWO_SIDED|95.0|0.62|1.602|||Andersen-Gill||HR was derived using an Andersen-Gill model, including the treatment arm, type of ATTR amyloidosis, baseline New York Heart Association (NYHA) class, and age as covariates.|||1.602|0.620|0.9888
91730741|NCT03997383|183356660|SUPERIORITY||Hazard Ratio (HR)|0.883||||0.5609|TWO_SIDED|95.0|0.582|1.341|||Modified Andersen-Gill|P-value was derived using the modified Andersen-Gill model stratified by baseline tafamidis use.|HR was derived using the modified Andersen-Gill model stratified by baseline tafamidis use, including treatment arm, type of ATTR amyloidosis, baseline NYHA class, and age as covariates.|||1.341|0.582|0.5609
91730742|NCT01302834|183356772|NON_INFERIORITY|The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.|Hazard Ratio (HR)|1.45|||||ONE_SIDED|95.0||1.94|||||Reference level = IMRT + Cisplatin|||1.94||
91492475|NCT03066804|182857297|SUPERIORITY||Odds Ratio (OR)|1.106||||0.4938|TWO_SIDED|95.0|0.8287|1.476|||longitudinal binary logistic regression|||||1.4760|0.8287|0.4938
91492476|NCT03066804|182857298|SUPERIORITY||Odds Ratio (OR)|0.9798||||0.8314|TWO_SIDED|95.0|0.8122|1.182|||Proportional cumulative odds model|||||1.1820|0.8122|0.8314
91492477|NCT03066804|182857299|SUPERIORITY||Mean Difference (Net)|-0.157||||0.637||95.0|-0.8093|0.4953|||Mixed Models Analysis|||||0.4953|-0.8093|0.6370
91492478|NCT00740831|182857300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|1.2|||||ONE_SIDED|97.5|-9.3||||||Newcombe-Wilson method for CI. Percentage in A minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||-9.3|
91528571|NCT01304082|182932754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
91528572|NCT03912220|182932755|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91730743|NCT01302834|183356773|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.0002|TWO_SIDED|95.0|1.29|2.29|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||2.29|1.29|0.0002
91730744|NCT01302834|183356774|SUPERIORITY||Hazard Ratio (HR)|2.05||||0.0005|TWO_SIDED|95.0|1.35|3.1|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||3.10|1.35|0.0005
91730745|NCT01302834|183356775|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.09|TWO_SIDED|95.0|0.94|2.36||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||2.36|0.94|0.09
91492479|NCT00740831|182857300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|8.8|||||ONE_SIDED|97.5|0.4||||||Newcombe-Wilson method for CI. Percentage in B minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||0.4|
91492480|NCT00740831|182857301|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.003|0.181||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.181|-0.003|
91492481|NCT00740831|182857301|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.043|0.14||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.14|-0.043|
91528573|NCT03912220|182932756|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91528574|NCT04654468|182932770|SUPERIORITY||||||<|0.0001|||||||Paired McNemar|||Percentage of participants who achieved TA from baseline through Week 25 were compared with the percentage of participants who reported TA within 24 weeks prior to screening.||||<.0001
91528575|NCT05064735|182932810|SUPERIORITY||Estimated Treatment Difference|-10.48|||<|0.0001|TWO_SIDED|95.0|-12.34|-8.63|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.||-8.63|-12.34|<0.0001
91528576|NCT05064735|182932811|SUPERIORITY||Estimated Treatment Difference|-14.14|||<|0.0001|TWO_SIDED|95.0|-19.98|-8.3|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline WOMAC pain score as covariate.||-8.30|-19.98|<0.0001
91528577|NCT03757234|182932861|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.6|||||TWO_SIDED|95.0|-12.4|6.9|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||6.9|-12.4|
91528578|NCT03757234|182932861|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.9|||||TWO_SIDED|95.0|-34.8|5.3|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||5.3|-34.8|
91730746|NCT01302834|183356776|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.61|1.58||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||1.58|0.61|0.95
91730747|NCT01302834|183356778|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.0
91730748|NCT01302834|183356786|SUPERIORITY|||||||0.79||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.79
91730749|NCT01302834|183356789|SUPERIORITY|||||||0.5438||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.5438
91730750|NCT01302834|183356793|SUPERIORITY|||||||0.7108||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.7108
91730751|NCT01302834|183356808|SUPERIORITY||Cox Proportional Hazard|0.87||||0.2571|TWO_SIDED|95.0|0.56|1.34||One-sided significance level = 0.025.|Regression, Cox|Stratified by treatment arm.|Reference level = non-variant|||1.34|0.56|0.2571
91730752|NCT01302834|183356809|SUPERIORITY||Cox Proportional Hazard|0.94||||0.3704|TWO_SIDED|95.0|0.64|1.38||One-sided significance level = 0.05.|Regression, Cox|Stratified by treatment arm.|Reference level = non-variant|||1.38|0.64|0.3704
91730753|NCT01302834|183356810|SUPERIORITY||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.49|2.46|||||Reference level = IMRT + Cisplatin|Variant||2.46|0.49|
91730754|NCT01302834|183356810|SUPERIORITY||Cox Proportional Hazard|1.1||||||95.0|0.79|1.53|||||Reference level = IMRT + Cisplatin|Non-variant||1.53|0.79|
91730755|NCT01302834|183356810|OTHER|||||||0.989||||||Two-sided significance level = 0.05|Regression, Cox|||Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.||||0.9890
91730756|NCT01302834|183356811|SUPERIORITY||Cox Proportional Hazard|1.01||||||95.0|0.5|2.04|||||Reference level = IMRT + Cisplatin|Variant||2.04|0.50|
91730757|NCT01302834|183356811|SUPERIORITY||Cox Proportional Hazard|1.27|||||TWO_SIDED|95.0|0.94|1.73|||||Reference level = IMRT + Cisplatin|Non-variant||1.73|0.94|
91699462|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3812|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3812
91699463|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0088
91699464|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0653|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0653
91699465|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6443|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6443
91730758|NCT01302834|183356811|OTHER|||||||0.5556||||||Two-sided significance level = 0.05|Regression, Cox|||Testing Cox proportional hazards model interaction term for KRAS variant status and treatment arm.||||0.5556
91730759|NCT05528510|183356815|SUPERIORITY||Adjusted Treatment Difference|21.1|||<|0.001|TWO_SIDED|95.0|14.5|27.6|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||27.6|14.5|<0.001
91730760|NCT05528510|183356816|SUPERIORITY||Adjusted Treatment Difference|30.4|||<|0.001|TWO_SIDED|95.0|21.6|39.2|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||39.2|21.6|<0.001
91730761|NCT05528510|183356817|SUPERIORITY||Adjusted Treatment Difference|24.3|||<|0.001|TWO_SIDED|95.0|16.6|31.9|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||31.9|16.6|<0.001
91492482|NCT00740831|182857302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
91492483|NCT00740831|182857302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
91730762|NCT05528510|183356818|SUPERIORITY||Adjusted Treatment Difference|31.0|||<|0.001|TWO_SIDED|95.0|21.6|40.5|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||40.5|21.6|<0.001
91730763|NCT05528510|183356819|SUPERIORITY||Adjusted Treatment Difference|19.6|||<|0.001|TWO_SIDED|95.0|12.4|26.9|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||26.9|12.4|<0.001
91730764|NCT05528510|183356820|SUPERIORITY||Adjusted Treatment Difference|25.9|||<|0.001|TWO_SIDED|95.0|16.7|35.1|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||35.1|16.7|<0.001
91730765|NCT05528510|183356820|SUPERIORITY||Adjusted Treatment Difference|27.0|||<|0.001|TWO_SIDED|95.0|17.9|36.2|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||36.2|17.9|<0.001
91730766|NCT05528510|183356821|SUPERIORITY||Adjusted Treatment Difference|29.5|||<|0.001|TWO_SIDED|95.0|18.5|40.5|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||40.5|18.5|<0.001
91730767|NCT05528510|183356821|SUPERIORITY||Adjusted Treatment Difference|24.8|||<|0.001|TWO_SIDED|95.0|14.3|35.3|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||35.3|14.3|<0.001
91730768|NCT05528510|183356822|SUPERIORITY||Adjusted Treatment Difference|28.1|||<|0.001|TWO_SIDED|95.0|18.5|37.6|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||37.6|18.5|<0.001
91492484|NCT00740831|182857303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
91492485|NCT00740831|182857303|SUPERIORITY_OR_OTHER||Median Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
91492486|NCT03982368|182857308|SUPERIORITY||least square mean difference|0.93||||0.078|TWO_SIDED|95.0|-1.47|3.32|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||3.32|-1.47|0.078
91492487|NCT03982368|182857308|SUPERIORITY||least square mean difference|2.31||||0.066|TWO_SIDED|95.0|-0.08|4.7|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.70|-0.08|0.066
91492488|NCT03982368|182857309|SUPERIORITY||Least square mean difference|1.71||||0.032|TWO_SIDED|95.0|-0.7|4.12|||ANOVA|||||4.12|-0.70|0.032
91492489|NCT03982368|182857309|SUPERIORITY||Least square mean difference|2.44||||0.029|TWO_SIDED|95.0|0.02|4.86|||ANOVA|||||4.86|0.02|0.029
91492490|NCT03982368|182857310|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||||||0.534
91492491|NCT03982368|182857310|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
91699466|NCT02612610|183293906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1511
91699467|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0045
91699468|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0947|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0947
91699469|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0080
91730769|NCT05528510|183356822|SUPERIORITY||Adjusted Treatment Difference|32.7|||<|0.001|TWO_SIDED|95.0|23.1|42.3|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||42.3|23.1|<0.001
91730770|NCT05528510|183356823|SUPERIORITY||Adjusted Treatment Difference|32.4|||<|0.001|TWO_SIDED|95.0|21.3|43.4|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||43.4|21.3|<0.001
91730771|NCT05528510|183356823|SUPERIORITY||Adjusted Treatment Difference|30.5|||<|0.001|TWO_SIDED|95.0|20.0|41.0|||Mantel Haenszel|Stratification was by Androgen Deprivation Therapy for Intermediate-Risk status (Yes/No) and Mayo endoscopy subscore at baseline(moderate or severe).||||41.0|20.0|<0.001
91730772|NCT01856478|183356825|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0016|TWO_SIDED|95.0|1.47|5.18||Null hypothesis: Afatinib and methotrexate have an equal response rate.|Cochran-Mantel-Haenszel||"Linear regression stratified by baseline ECOG performance score and use of prior EGFR-targeted antibody in the R/M setting was used to calculate the OR of response and its confidence interval.~Data presented as Afatinib versus Methotrexate."|Stratified Cochran-Mantel-Haenszel was used to test the effect of afatinib compared with methotrexate. The stratification was done on the baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No).||5.18|1.47|0.0016
91492492|NCT03982368|182857311|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||0.486
91492493|NCT03982368|182857311|SUPERIORITY|||||||0.564|||||||t-test, 2 sided|||||||0.564
91492494|NCT03982368|182857313|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.810
91492495|NCT03982368|182857313|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||||||0.733
91492496|NCT03982368|182857314|SUPERIORITY||Least square mean difference|1.97||||0.025|TWO_SIDED|95.0|-0.19|4.13|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.13|-0.19|0.025
91492497|NCT03982368|182857314|SUPERIORITY||Least square mean difference|0.68||||0.243|TWO_SIDED|95.0|-1.48|2.83|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||2.83|-1.48|0.243
91759155|NCT04038567|183411362|SUPERIORITY||Mean Difference (Final Values)|-0.82|||||TWO_SIDED|95.0|-1.8|1.49||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-1.80|
91730773|NCT01856478|183356826|SUPERIORITY|Stratified log-rank test was used to test the effect of afatinib on PFS compared with methotrexate. The stratification was done on the baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No).|Hazard Ratio (HR)|0.627||||0.0005|TWO_SIDED|95.0|0.478|0.823||Null hypothesis: Afatinib and methotrexate are equally effective in terms of PFS.|Log Rank||"Cox proportional hazards model stratified by baseline ECOG performance score and use of prior EGFR-targeted antibody in the R/M setting was used to calculate HR and its confidence interval.~Data presented as Afatinib versus Methotrexate."|||0.823|0.478|0.0005
91730774|NCT01856478|183356827|OTHER||Hazard Ratio (HR)|0.881||||0.3162|TWO_SIDED|95.0|0.687|1.129|||Log Rank||"Cox proportional hazards model stratified by baseline ECOG performance score and use of prior EGFR-targeted antibody in the R/M setting was used to calculate HR and its confidence interval.~Data presented as Afatinib versus Methotrexate."|Stratified log-rank test was used to test the effect of afatinib compared with methotrexate. The stratification was done on the baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No).||1.129|0.687|0.3162
91730775|NCT01856478|183356828|OTHER||Hazard Ratio (HR)|0.79||||0.2121|TWO_SIDED|95.0|0.54|1.15|||Log Rank||"Cox proportional hazards model stratified by baseline ECOG performance score and use of prior EGFR-targeted antibody in the R/M setting was used to calculate HR and its confidence interval.~Data presented as Afatinib versus Methotrexate."|Stratified log-rank test was used to test the effect of afatinib compared with methotrexate. The stratification was done on the baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No).||1.15|0.54|0.2121
91730776|NCT01856478|183356829|OTHER||Hazard Ratio (HR)|1.0||||0.9888|TWO_SIDED|95.0|0.67|1.49|||Log Rank||"Cox proportional hazards model stratified by baseline ECOG performance score and use of prior EGFR-targeted antibody in the R/M setting was used to calculate HR and its confidence interval.~Data presented as Afatinib versus Methotrexate."|Stratified log-rank test was used to test the effect of afatinib compared with methotrexate. The stratification was done on the baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No).||1.49|0.67|0.9888
91492498|NCT03982368|182857315|SUPERIORITY||Least square mean difference|2.41||||0.007|TWO_SIDED|95.0|0.28|4.54|||ANOVA|||||4.54|0.28|0.007
91492499|NCT03982368|182857315|SUPERIORITY||Least square mean difference|0.71||||0.23|TWO_SIDED|95.0|-1.43|2.85|||ANOVA|||||2.85|-1.43|0.230
91492500|NCT03982368|182857316|SUPERIORITY||Least square mean difference|-1.16||||0.799|TWO_SIDED|95.0|-3.11|0.8|||ANOVA|Last Observation Carried Forward (LOCF) was used for imputing missing data in the Full analysis set at Week 4.||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.80|-3.11|0.799
91492501|NCT03982368|182857316|SUPERIORITY||Least square mean difference|-0.36||||0.715|TWO_SIDED|95.0|-2.3|1.59|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||1.59|-2.30|0.715
91492502|NCT03982368|182857317|SUPERIORITY||Least square mean difference|-1.54||||0.831|TWO_SIDED|95.0|-3.4|0.31|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.31|-3.40|0.831
91492503|NCT03982368|182857317|SUPERIORITY||Least square mean difference|-0.21||||0.75|TWO_SIDED|95.0|-2.07|1.66|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||1.66|-2.07|0.750
91492504|NCT03982368|182857318|SUPERIORITY||Least square mean difference|0.96||||0.004|TWO_SIDED|95.0|0.17|1.75|||ANOVA|||||1.75|0.17|0.004
91492505|NCT03982368|182857318|SUPERIORITY||Least square mean difference|0.28||||0.217|TWO_SIDED|95.0|-0.51|1.07|||ANOVA|||||1.07|-0.51|0.217
91492506|NCT03982368|182857319|SUPERIORITY||Least square mean difference|0.92||||0.007|TWO_SIDED|95.0|0.1|1.74|||ANOVA|||||1.74|0.10|0.007
91492507|NCT03982368|182857319|SUPERIORITY||Least square mean difference|0.28||||0.225|TWO_SIDED|95.0|-0.54|1.1|||ANOVA|||||1.10|-0.54|0.225
91492508|NCT03982368|182857320|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.680
91492509|NCT03982368|182857320|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||0.066
91492510|NCT03982368|182857321|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
91492511|NCT03982368|182857321|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
91492512|NCT03982368|182857322|SUPERIORITY||Least square mean difference|16.4||||0.289|TWO_SIDED|95.0|12.0|20.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||20.8|12.0|0.289
91492513|NCT03982368|182857322|SUPERIORITY||Least square mean difference|19.7||||0.032|TWO_SIDED|95.0|15.4|24.0|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.0|15.4|0.032
91492514|NCT03982368|182857322|SUPERIORITY||Least square mean difference|16.4||||0.095|TWO_SIDED|95.0|11.9|20.8|||ANOVA|||Daily Activity Limitations - change to baseline to week 8||20.8|11.9|0.095
91492515|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.5||||0.282|TWO_SIDED|95.0|10.1|18.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||18.8|10.1|0.282
91492516|NCT03982368|182857322|SUPERIORITY||Least square mean difference|15.0||||0.169|TWO_SIDED|95.0|10.6|19.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.4|10.6|0.169
91492517|NCT03982368|182857322|SUPERIORITY||Least square mean difference|15.4||||0.129|TWO_SIDED|95.0|11.1|19.7|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.7|11.1|0.129
91492518|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.0||||0.111|TWO_SIDED|95.0|9.7|18.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.4|9.7|0.111
91492519|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.0||||0.107|TWO_SIDED|95.0|9.7|18.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.3|9.7|0.107
91492520|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.3||||0.827|TWO_SIDED|95.0|9.7|18.9|||ANOVA|||Emotional Well-Being - change from baseline to week 4||18.9|9.7|0.827
91699470|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
91528579|NCT03757234|182932861|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.0|||||TWO_SIDED|95.0|-30.6|8.2|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||8.2|-30.6|
91699471|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1493
91699472|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0026
91699473|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0652|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0652
91699474|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3601|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3601
91699475|NCT02612610|183293907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0086
91699476|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3893|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3893
91699477|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2803|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2803
91699478|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0427|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0427
91699479|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0209|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0209
91699480|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3401|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3401
91759156|NCT04038567|183411362|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.48|1.49||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-0.48|
91492521|NCT03982368|182857322|SUPERIORITY||Least square mean difference|16.3||||0.688|TWO_SIDED|95.0|11.8|20.8|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.8|11.8|0.688
91492522|NCT03982368|182857322|SUPERIORITY||Least square mean difference|15.7||||0.324|TWO_SIDED|95.0|11.4|20.0|||ANOVA|||Emotional Well-Being - change from baseline to week 8||20.0|11.4|0.324
91492523|NCT03982368|182857322|SUPERIORITY||Least square mean difference|12.9||||0.949|TWO_SIDED|95.0|8.7|17.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||17.1|8.7|0.949
91492524|NCT03982368|182857322|SUPERIORITY||Least square mean difference|15.7||||0.927|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.1|11.4|0.927
91492525|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.8||||0.776|TWO_SIDED|95.0|10.8|18.8|||ANOVA|||Emotional Well-Being - change from baseline to week 12||18.8|10.8|0.776
91492526|NCT03982368|182857322|SUPERIORITY||Least square mean difference|15.7||||0.418|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.1|11.4|0.418
91492527|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.8||||0.613|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||19.0|10.6|0.613
91492528|NCT03982368|182857322|SUPERIORITY||Least square mean difference|15.8||||0.721|TWO_SIDED|95.0|8.3|23.2|||ANOVA|||Work Limitations - change from baseline to week 4||23.2|8.3|0.721
91492529|NCT03982368|182857322|SUPERIORITY||Least square mean difference|20.6||||0.558|TWO_SIDED|95.0|13.1|28.0|||ANOVA|||Work Limitations - change from baseline to week 4||28.0|13.1|0.558
91492530|NCT03982368|182857322|SUPERIORITY||Least square mean difference|18.4||||0.809|TWO_SIDED|95.0|11.5|25.3|||ANOVA|||Work Limitations - change from baseline to week 8||25.3|11.5|0.809
91492531|NCT03982368|182857322|SUPERIORITY||Least square mean difference|19.4||||0.651|TWO_SIDED|95.0|12.4|26.4|||ANOVA|||Work Limitations - change from baseline to week 8||26.4|12.4|0.651
91492532|NCT03982368|182857322|SUPERIORITY||Least square mean difference|16.4||||0.769|TWO_SIDED|95.0|9.5|23.3|||ANOVA|||Work Limitations - change from baseline to week 12||23.3|9.5|0.769
91492533|NCT03982368|182857322|SUPERIORITY||Least square mean difference|21.3||||0.454|TWO_SIDED|95.0|14.3|28.3|||ANOVA|||Work Limitations - change from baseline to week 12||28.3|14.3|0.454
91492534|NCT03982368|182857322|SUPERIORITY||Least square mean difference|18.3||||0.564|TWO_SIDED|95.0|11.6|25.0|||ANOVA|||Work Limitations - change from baseline to week 16||25.0|11.6|0.564
91492535|NCT03982368|182857322|SUPERIORITY||Least square mean difference|21.0||||0.25|TWO_SIDED|95.0|14.1|27.8|||ANOVA|||Work Limitations - change from baseline to week 16||27.8|14.1|0.250
91492536|NCT03982368|182857322|SUPERIORITY||Least square mean difference|23.9||||0.853|TWO_SIDED|95.0|15.6|32.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||32.2|15.6|0.853
91492537|NCT03982368|182857322|SUPERIORITY||Least square mean difference|20.0||||0.393|TWO_SIDED|95.0|11.9|28.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||28.0|11.9|0.393
91492538|NCT03982368|182857322|SUPERIORITY||Least square mean difference|27.9||||0.01|TWO_SIDED|95.0|20.2|35.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||35.6|20.2|0.010
91699481|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0031
91492539|NCT03982368|182857322|SUPERIORITY||Least square mean difference|18.3||||0.395|TWO_SIDED|95.0|11.1|25.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||25.4|11.1|0.395
91492540|NCT03982368|182857322|SUPERIORITY||Least square mean difference|24.8||||0.068|TWO_SIDED|95.0|17.1|32.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||32.4|17.1|0.068
91492541|NCT03982368|182857322|SUPERIORITY||Least square mean difference|19.3||||0.4|TWO_SIDED|95.0|12.2|26.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||26.4|12.2|0.400
91492542|NCT03982368|182857322|SUPERIORITY||Least square mean difference|25.5||||0.021|TWO_SIDED|95.0|18.1|33.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.0|18.1|0.021
91492543|NCT03982368|182857322|SUPERIORITY||Least square mean difference|23.1||||0.056|TWO_SIDED|95.0|16.1|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||30.0|16.1|0.056
91492544|NCT03982368|182857322|SUPERIORITY||Least square mean difference|14.2||||0.981|TWO_SIDED|95.0|7.6|20.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||20.7|7.6|0.981
91492545|NCT03982368|182857322|SUPERIORITY||Least square mean difference|17.0||||0.525|TWO_SIDED|95.0|11.1|22.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.9|11.1|0.525
91492546|NCT03982368|182857322|SUPERIORITY||Least square mean difference|9.5||||0.356|TWO_SIDED|95.0|2.9|16.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||16.0|2.9|0.356
91528580|NCT03757234|182932861|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|0.9|||||TWO_SIDED|95.0|-22.4|11.8|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||11.8|-22.4|
91528581|NCT03757234|182932862|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.4|||||TWO_SIDED|95.0|-23.6|12.7|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||12.7|-23.6|
91492547|NCT03982368|182857322|SUPERIORITY||Least square mean difference|6.5||||0.771|TWO_SIDED|95.0|0.7|12.4|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||12.4|0.7|0.771
91492548|NCT03982368|182857322|SUPERIORITY||Least square mean difference|8.7||||0.926|TWO_SIDED|95.0|2.0|15.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.5|2.0|0.926
91492549|NCT03982368|182857322|SUPERIORITY||Least square mean difference|7.9||||0.778|TWO_SIDED|95.0|1.9|13.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||13.9|1.9|0.778
91492550|NCT03982368|182857322|SUPERIORITY||Least square mean difference|10.0||||0.984|TWO_SIDED||||||ANOVA|||Treatment-Related Bother - change from baseline to week 16||||0.984
91492551|NCT03982368|182857322|SUPERIORITY||Least square mean difference|7.4||||0.514|TWO_SIDED|95.0|1.6|13.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||13.1|1.6|0.514
91492552|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-16.6||||0.985|TWO_SIDED|95.0|-20.4|-12.8|||ANOVA|||Symptom Bother - change from baseline to week 4||-12.8|-20.4|0.985
91492553|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-17.8||||0.646|TWO_SIDED|95.0|-21.5|-14.0|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.0|-21.5|0.646
91492554|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-20.7||||0.007|TWO_SIDED|95.0|-24.5|-16.9|||ANOVA|||Symptom Bother - change from baseline to week 8||-16.9|-24.5|0.007
91492555|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-16.2||||0.305|TWO_SIDED|95.0|-19.9|-12.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-12.5|-19.9|0.305
91492556|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-19.0||||0.015|TWO_SIDED|95.0|-22.7|-15.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.4|-22.7|0.015
91492557|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-18.0||||0.039|TWO_SIDED|95.0|-21.5|-14.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-14.4|-21.5|0.039
91528582|NCT03757234|182932862|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-47.7|||||TWO_SIDED|95.0|-71.3|-6.0|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-6.0|-71.3|
91699482|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
91699483|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6233|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6233
91699484|NCT02612610|183293908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
91699485|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4925|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4925
91699486|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9007|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9007
91699487|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
91699488|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3440
91492558|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-19.7||||0.001|TWO_SIDED|95.0|-23.3|-16.0|||ANOVA|||||-16.0|-23.3|0.001
91492559|NCT03982368|182857322|SUPERIORITY||Least square mean difference|-18.9||||0.002|TWO_SIDED|95.0|-22.4|-15.3|||ANOVA|||Symptom Bother - change from baseline to week 16||-15.3|-22.4|0.002
91492560|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.8||||0.241|TWO_SIDED|95.0|12.2|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||21.4|12.2|0.241
91492561|NCT03982368|182857323|SUPERIORITY||Least square mean difference|19.7||||0.04|TWO_SIDED|95.0|15.1|24.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.4|15.1|0.040
91492562|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.8||||0.097|TWO_SIDED|95.0|12.3|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||21.4|12.3|0.097
91492563|NCT03982368|182857323|SUPERIORITY||Least square mean difference|15.3||||0.238|TWO_SIDED|95.0|10.7|19.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||19.9|10.7|0.238
91492564|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.5||||0.07|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||20.9|12.0|0.070
91492565|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.7||||0.058|TWO_SIDED|95.0|12.3|21.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||21.1|12.3|0.058
91492566|NCT03982368|182857323|SUPERIORITY||Least square mean difference|13.7||||0.128|TWO_SIDED|95.0|9.3|18.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.1|9.3|0.128
91492567|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.0||||0.024|TWO_SIDED|95.0|11.6|20.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||20.3|11.6|0.024
91492568|NCT03982368|182857323|SUPERIORITY||Least square mean difference|15.2||||0.865|TWO_SIDED|95.0|10.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.1|10.4|0.865
91492569|NCT03982368|182857323|SUPERIORITY||Least square mean difference|17.3||||0.662|TWO_SIDED|95.0|12.4|22.2|||ANOVA|||Emotional Well-Being - change from baseline to week 4||22.2|12.4|0.662
91492570|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.7||||0.266|TWO_SIDED|95.0|12.2|21.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||21.1|12.2|0.266
91492571|NCT03982368|182857323|SUPERIORITY||Least square mean difference|13.9||||0.824|TWO_SIDED|95.0|9.4|18.3|||ANOVA|||Emotional Well-Being - change from baseline to week 8||18.3|9.4|0.824
91492572|NCT03982368|182857323|SUPERIORITY||Least square mean difference|14.8||||0.883|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 12||19.0|10.6|0.883
91492573|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.3||||0.516|TWO_SIDED|95.0|12.1|20.4|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.4|12.1|0.516
91492574|NCT03982368|182857323|SUPERIORITY|Emotional Well-Being - change from baseline to week 16|Least square mean difference|16.5||||0.407|TWO_SIDED|95.0|12.1|21.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||21.0|12.1|0.407
91492575|NCT03982368|182857323|SUPERIORITY||Least square mean difference|16.4||||0.422|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.9|12.0|0.422
91528583|NCT03757234|182932862|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.7|||||TWO_SIDED|95.0|-40.8|15.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||15.1|-40.8|
91528584|NCT03757234|182932862|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-36.5|||||TWO_SIDED|95.0|-62.6|-1.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-1.1|-62.6|
91528585|NCT00610701|182932869|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
91699489|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9876|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9876
91699490|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
91492576|NCT03982368|182857323|SUPERIORITY||Least square mean difference|15.9||||0.615|TWO_SIDED|95.0|8.1|23.8|||ANOVA|||Work Limitations - change from baseline to week 4||23.8|8.1|0.615
91492577|NCT03982368|182857323|SUPERIORITY||Least square mean difference|21.3||||0.626|TWO_SIDED|95.0|13.3|29.2|||ANOVA|||Work Limitations - change from baseline to week 4||29.2|13.3|0.626
91492578|NCT03982368|182857323|SUPERIORITY||Least square mean difference|18.3||||0.968|TWO_SIDED|95.0|11.1|25.6|||ANOVA|||Work Limitations - change from baseline to week 8||25.6|11.1|0.968
91492579|NCT03982368|182857323|SUPERIORITY||Least square mean difference|20.1||||0.689|TWO_SIDED|95.0|12.8|27.4|||ANOVA|||||27.4|12.8|0.689
91528586|NCT01152294|182932870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6|STANDARD_DEVIATION|2.4||0.01|TWO_SIDED|95.0|1.02|7.96|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||7.96|1.02|0.01
91492580|NCT03982368|182857323|SUPERIORITY||Least square mean difference|15.6||||0.528|TWO_SIDED|95.0|8.5|22.7|||ANOVA|||Work Limitations - change from baseline to week 12||22.7|8.5|0.528
91492581|NCT03982368|182857323|SUPERIORITY||Least square mean difference|23.0||||0.368|TWO_SIDED|95.0|15.8|30.1|||ANOVA|||Work Limitations - change from baseline to week 12||30.1|15.8|0.368
91492582|NCT03982368|182857323|SUPERIORITY||Least square mean difference|17.7||||0.764|TWO_SIDED|95.0|10.7|24.7|||ANOVA|||Work Limitations - change from baseline to week 16||24.7|10.7|0.764
91492583|NCT03982368|182857323|SUPERIORITY||Least square mean difference|22.6||||0.184|TWO_SIDED|95.0|15.5|29.6|||ANOVA|||Work Limitations - change from baseline to week 16||29.6|15.5|0.184
91492584|NCT03982368|182857323|SUPERIORITY||Least square mean difference|25.4||||0.909|TWO_SIDED|95.0|16.5|34.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||34.2|16.5|0.909
91492585|NCT03982368|182857323|SUPERIORITY||Least square mean difference|21.1||||0.428|TWO_SIDED|95.0|12.2|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||30.0|12.2|0.428
91492586|NCT03982368|182857323|SUPERIORITY||Least square mean difference|29.8||||0.008|TWO_SIDED|95.0|21.6|37.9|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||37.9|21.6|0.008
91492587|NCT03982368|182857323|SUPERIORITY||Least square mean difference|21.3||||0.222|TWO_SIDED|95.0|13.5|29.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||29.2|13.5|0.222
91492588|NCT03982368|182857323|SUPERIORITY||Least square mean difference|25.3||||0.082|TWO_SIDED|95.0|17.2|33.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||33.4|17.2|0.082
91492589|NCT03982368|182857323|SUPERIORITY||Least square mean difference|23.3||||0.154|TWO_SIDED|95.0|15.6|31.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||31.1|15.6|0.154
91699491|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5968|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5968
91492590|NCT03982368|182857323|SUPERIORITY||Least square mean difference|25.8||||0.03|TWO_SIDED|95.0|18.0|33.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.6|18.0|0.030
91492591|NCT03982368|182857323|SUPERIORITY||Least square mean difference|24.6||||0.046|TWO_SIDED|95.0|17.1|32.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||32.1|17.1|0.046
91528587|NCT02736968|182932887|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.12|0.12||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of resolution of diarrhea by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.12|-0.12|>0.999
91699492|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8726|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.8726
91699493|NCT02612610|183293909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4092|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4092
91699494|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0781
91699495|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7098|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7098
91699496|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0068|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0068
91699497|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1284|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1284
91699498|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.267|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2670
91492592|NCT03982368|182857323|SUPERIORITY||Least square mean difference|15.4||||0.861|TWO_SIDED|95.0|8.6|22.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.2|8.6|0.861
91492593|NCT03982368|182857323|SUPERIORITY||Least square mean difference|15.3||||0.865|TWO_SIDED|95.0|9.0|21.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||21.7|9.0|0.865
91492594|NCT03982368|182857323|SUPERIORITY||Least square mean difference|10.5||||0.278|TWO_SIDED|95.0|3.6|17.3|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||17.3|3.6|0.278
91492595|NCT03982368|182857323|SUPERIORITY||Least square mean difference|7.2||||0.689|TWO_SIDED|95.0|0.9|13.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||13.5|0.9|0.689
91699499|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0013
91699500|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4343|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4343
91699501|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5384|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5384
91759157|NCT04038567|183411363|SUPERIORITY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-1.66|1.01||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.01|-1.66|
91699502|NCT02612610|183293910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0822
91699503|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
91699504|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0223|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0223
91492596|NCT03982368|182857323|SUPERIORITY||Least square mean difference|9.1||||0.993|TWO_SIDED|95.0|2.1|16.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||16.2|2.1|0.993
91699505|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
91730777|NCT01856478|183356830|OTHER||Hazard Ratio (HR)|0.91||||0.626|TWO_SIDED|95.0|0.62|1.34|||Log Rank||"Cox proportional hazards model stratified by baseline ECOG performance score and use of prior EGFR-targeted antibody in the R/M setting was used to calculate HR and its confidence interval.~Data presented as Afatinib versus Methotrexate."|Stratified log-rank test was used to test the effect of afatinib compared with methotrexate. The stratification was done on the baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No).||1.34|0.62|0.6260
91730778|NCT01856478|183356831|OTHER||Adjusted mean difference|7.9||||0.0005|TWO_SIDED|95.0|3.45|12.36|||t-test, 2 sided||Calculated as \[Afatinib\]-\[Methotrexate\]|||12.36|3.45|0.0005
91730779|NCT01856478|183356832|OTHER||Adjusted mean difference|-3.8||||0.109|TWO_SIDED|95.0|-8.39|0.84|||t-test, 2 sided||Calculated as \[Afatinib\]-\[Methotrexate\]|||0.84|-8.39|0.1090
91730780|NCT01856478|183356833|OTHER||Adjusted mean difference|-3.9||||0.1819|TWO_SIDED|95.0|-9.73|1.85|||t-test, 2 sided||Calculated as \[Afatinib\]-\[Methotrexate\]|||1.85|-9.73|0.1819
91730781|NCT01856478|183356834|OTHER||Odds Ratio (OR)|1.46||||0.222|||||||Regression, Logistic||Afatinib versus Methotrexate|Stratified logistic regression model stratified by baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No) was used to compare the number of patients that of improved vs. not improved (i.e. stable and worsened) between the two treatment groups.||||0.222
91730782|NCT01856478|183356835|OTHER||Odds Ratio (OR)|2.37||||0.012|||||||Regression, Logistic||Afatinib versus Methotrexate|Stratified logistic regression model stratified by baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No) was used to compare the number of patients that of improved vs. not improved (i.e. stable and worsened) between the two treatment groups.||||0.012
91492597|NCT03982368|182857323|SUPERIORITY||Least square mean difference|9.2||||0.989|TWO_SIDED|95.0|2.8|15.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.7|2.8|0.989
91492598|NCT03982368|182857323|SUPERIORITY||Least square mean difference|10.4||||0.976|TWO_SIDED|95.0|3.7|17.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||17.0|3.7|0.976
91492599|NCT03982368|182857323|SUPERIORITY||Least square mean difference|9.0||||0.778|TWO_SIDED|95.0|2.9|15.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||15.1|2.9|0.778
91730783|NCT01856478|183356836|OTHER|||||||0.008|||||||Regression, Logistic|||Stratified logistic regression model stratified by baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No) was used to compare the number of patients that of improved vs. not improved (i.e. stable and worsened) between the two treatment groups.||||0.008
91492600|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-17.3||||0.964|TWO_SIDED|95.0|-21.2|-13.3|||ANOVA|||Symptom Bother - change from baseline to week 4||-13.3|-21.2|0.964
91492601|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-18.7||||0.581|TWO_SIDED|95.0|-22.7|-14.7|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.7|-22.7|0.581
91492602|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-21.4||||0.006|TWO_SIDED|95.0|-25.2|-17.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-17.5|-25.2|0.006
91492603|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-17.6||||0.175|TWO_SIDED|95.0|-21.4|-13.7|||ANOVA|||Symptom Bother - change from baseline to week 8||-13.7|-21.4|0.175
91730784|NCT01856478|183356837|OTHER|||||||0.091|||||||Regression, Logistic|||Stratified logistic regression model stratified by baseline ECOG performance score (0 or 1) and use of prior EGFR-targeted antibody in the R/M setting (Yes or No) was used to compare the number of patients that of improved vs. not improved (i.e. stable and worsened) between the two treatment groups.||||0.091
91730785|NCT05032820|183356838|SUPERIORITY||Proportion of Patients Achieving CR/sCR|65.8|||<|0.0001|TWO_SIDED|90.0|51.2|78.4||p-value is calculated using Fisher's exact test and is a one-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.|Fisher Exact|One-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.||||78.4|51.2|<0.0001
91730786|NCT04108208|183356854|SUPERIORITY||Hazard Ratio (HR)|0.233|||=|0.0052|TWO_SIDED|95.0|0.077|0.705|||Log Rank|||||0.705|0.077|=0.0052
91492604|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-19.4||||0.016|TWO_SIDED|95.0|-23.1|-15.6|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.6|-23.1|0.016
91492605|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-19.8||||0.01|TWO_SIDED|95.0|-23.5|-16.1|||ANOVA|||Symptom Bother - change from baseline to week 12||-16.1|-23.5|0.010
91492606|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-20.5||||0|TWO_SIDED|95.0|-24.3|-16.8|||ANOVA|||Symptom Bother - change from baseline to week 16||-16.8|-24.3|0.000
91492607|NCT03982368|182857323|SUPERIORITY||Least square mean difference|-20.8||||0|TWO_SIDED|95.0|-24.6|-17.1|||ANOVA|||Symptom Bother - change from baseline to week 16||-17.1|-24.6|0.000
91492608|NCT03982368|182857324|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.302
91492609|NCT03982368|182857324|SUPERIORITY|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.224
91492610|NCT03982368|182857324|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.000
91492611|NCT03982368|182857324|SUPERIORITY|||||||0.885|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.885
91492612|NCT03982368|182857324|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.035
91492613|NCT03982368|182857324|SUPERIORITY|||||||0.698|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.698
91699506|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0165
91492614|NCT03982368|182857324|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.016
91492615|NCT03982368|182857324|SUPERIORITY|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.706
91492616|NCT03982368|182857325|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.210
91528588|NCT02736968|182932888|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.34|0.34||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of parasitological response by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.34|-0.34|>0.999
91528589|NCT02736968|182932893|SUPERIORITY|||||||0.142||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||The null hypothesis is that there is no difference in time to resolution of diarrhea between treatment arms, with a two-sided alternative.||||0.142
91492617|NCT03982368|182857325|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||at weeek 4||||0.260
91492618|NCT03982368|182857325|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||At week 8 (FUP)||||0.000
91492619|NCT03982368|182857325|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.734
91492620|NCT03982368|182857325|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.050
91492621|NCT03982368|182857325|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.985
91492622|NCT03982368|182857325|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.018
91492623|NCT03982368|182857325|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.580
91492624|NCT03982368|182857326|SUPERIORITY||Least square mean difference|1.2||||0.282|TWO_SIDED|95.0|-1.0|3.3|||ANOVA|||statistical analysis at week 4||3.3|-1.0|0.282
91492625|NCT03982368|182857326|SUPERIORITY||Least square mean difference|3.9||||0.497|TWO_SIDED|95.0|1.7|6.0|||ANOVA|||statistical analysis at week 4||6.0|1.7|0.497
91492626|NCT03982368|182857326|SUPERIORITY||Least square mean difference|2.6||||0.734|TWO_SIDED|95.0|0.5|4.8|||ANOVA|||statistical analysis at week 8||4.8|0.5|0.734
91492627|NCT03982368|182857326|SUPERIORITY||Least square mean difference|2.2||||0.963|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||statistical analysis at week 8||4.3|0.1|0.963
91492628|NCT03982368|182857326|SUPERIORITY||Least square mean difference|2.7||||0.854|TWO_SIDED|95.0|0.7|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.7|0.854
91492629|NCT03982368|182857326|SUPERIORITY||Least square mean difference|2.8||||0.881|TWO_SIDED|95.0|0.8|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.8|0.881
91492630|NCT03982368|182857326|SUPERIORITY||Least square mean difference|3.0||||0.632|TWO_SIDED|95.0|0.3|5.7|||ANOVA|||statistical analysis at week 16||5.7|0.3|0.632
91492631|NCT03982368|182857326|SUPERIORITY||Least square mean difference|4.4||||0.22|TWO_SIDED|95.0|1.7|7.0|||ANOVA|||statistical analysis at week 16||7.0|1.7|0.220
91492632|NCT03982368|182857327|SUPERIORITY||Least square mean difference|1.2||||0.296|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|||statistical analysis at week 4||3.3|-0.9|0.296
91492633|NCT03982368|182857327|SUPERIORITY||Least square mean difference|3.6||||0.57|TWO_SIDED|95.0|1.5|5.7|||ANOVA|||statistical analysis at week 4||5.7|1.5|0.570
91492634|NCT03982368|182857327|SUPERIORITY||Least square mean difference|2.7||||0.754|TWO_SIDED|95.0|0.5|4.9|||ANOVA|||statistical analysis at week 8||4.9|0.5|0.754
91492635|NCT03982368|182857327|SUPERIORITY||Least square mean difference|2.3||||0.972|TWO_SIDED|95.0|0.0|4.5|||ANOVA|||statistical analysis at week 8||4.5|0.0|0.972
91492636|NCT03982368|182857327|SUPERIORITY||Least square mean difference|3.4||||0.793|TWO_SIDED|95.0|1.4|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.4|0.793
91492637|NCT03982368|182857327|SUPERIORITY||Least square mean difference|3.4||||0.766|TWO_SIDED|95.0|1.5|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.5|0.766
91492638|NCT03982368|182857327|SUPERIORITY||Least square mean difference|3.3||||0.458|TWO_SIDED|95.0|0.6|6.0|||ANOVA|||statistical analysis at week 16||6.0|0.6|0.458
91492639|NCT03982368|182857327|SUPERIORITY||Least square mean difference|4.6||||0.147|TWO_SIDED|95.0|2.0|7.3|||ANOVA|||statistical analysis at week 16||7.3|2.0|0.147
91492640|NCT03570697|182857328|SUPERIORITY||Treatment difference|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.015|TWO_SIDED|95.0|4.7|37.7|||ANCOVA|||||37.7|4.7|0.015
91492641|NCT03570697|182857329|SUPERIORITY||Treatment difference|37.47|STANDARD_ERROR_OF_MEAN|17.04||0.041|TWO_SIDED|95.0|1.63|73.31|||ANCOVA|||||73.31|1.63|0.041
91730787|NCT04770272|183356880|SUPERIORITY|The primary analysis uses Bayesian statistics for proportions, and is based on non-informative uniform (beta) priors for the pCR rates pA and pB in arms A (experimental) and B (control) respectively. Similar to a proof-of-concept trial, a dual criterion to simultaneously test for significant and relevant superiority at different levels of certainty was used, by requiring posterior probabilities, conditional on observed response counts xA, xB respectively in the two arms.|Risk Difference (RD)|-0.0327|||||TWO_SIDED|95.0|-0.1307|0.0663||||||This was a randomized, open-label, adaptive, two arm, multicenter phase II trial that enrolled female and male patients with primary TNBC (defined as ER/PR \< 10% and HER2-negative) with tumor stages cT1c - cT4d (cN0 and cN+). Patients were randomized to Arm A and B, stratified by PD-L1 expression on immune cells (IC-status) and anatomic tumor stage (Anatomic Stage Groups I, II and III). PD-L1 status was determined by central pathology using the VENTANA PD-L1 (SP142) assay.||0.0663|-0.1307|
91730788|NCT04770272|183356882|SUPERIORITY||Risk Difference (RD)|-0.0411|||||TWO_SIDED|95.0|-0.1497|0.0689||||||||0.0689|-0.1497|
91730789|NCT04770272|183356883|SUPERIORITY||Risk Difference (RD)|0.0323|||||TWO_SIDED|95.0|-0.1957|0.2524||||||||0.2524|-0.1957|
91730790|NCT04770272|183356884|SUPERIORITY||Risk Difference (RD)|-0.051|||||TWO_SIDED|95.0|-0.153|0.051||||||||0.051|-0.153|
91730791|NCT04770272|183356885|SUPERIORITY||Risk Difference (RD)|-0.041|||||TWO_SIDED|95.0|-0.127|0.044||||||||0.044|-0.127|
91730792|NCT04770272|183356886|SUPERIORITY||Risk Difference (RD)|-0.064|||||TWO_SIDED|95.0|-0.166|0.034||||||||0.034|-0.166|
91730793|NCT04770272|183356887|SUPERIORITY||Risk Difference (RD)|-0.233|||||TWO_SIDED|95.0|-0.326|-0.14|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||-0.14|-0.326|
91730794|NCT04770272|183356888|SUPERIORITY||Risk Difference (RD)|0.039|||||TWO_SIDED|95.0|-0.078|0.15|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||0.15|-0.078|
91730795|NCT04770272|183356889|SUPERIORITY||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.245|-0.054|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||-0.054|-0.245|
91730796|NCT04770272|183356890|SUPERIORITY||Risk Difference (RD)|-0.052|||||TWO_SIDED|95.0|-0.157|0.055|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||0.055|-0.157|
91730797|NCT04770272|183356891|SUPERIORITY||Risk Difference (RD)|-0.001|||||TWO_SIDED|95.0|-0.022|0.018|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||0.018|-0.022|
91730798|NCT04770272|183356892|SUPERIORITY||Risk Difference (RD)|0.007|||||TWO_SIDED|95.0|-0.017|0.034|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||0.034|-0.017|
91730799|NCT04770272|183356893|SUPERIORITY||Risk Difference (RD)|-0.229|||||TWO_SIDED|95.0|-0.31|-0.148|||||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|-0.148|-0.31|
91730800|NCT04770272|183356894|SUPERIORITY||Risk Difference (RD)|0.056|||||TWO_SIDED|95.0|-0.052|0.163|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||0.163|-0.052|
91730801|NCT04770272|183356895|SUPERIORITY||Risk Difference (RD)|-0.343|||||TWO_SIDED|95.0|-0.447|-0.238|||||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|-0.238|-0.447|
91730802|NCT04770272|183356896|SUPERIORITY||Risk Difference (RD)|0.035|||||TWO_SIDED|95.0|-0.076|0.146|||||CI given as High posterior density interval (Bayesian confidence interval based on posterior distribution of effect/parameter of interest).|||0.146|-0.076|
91730803|NCT04770272|183356897|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.29|TWO_SIDED|95.0|0.69|3.43|||Regression, Cox|||||3.43|0.69|0.290
91492642|NCT03570697|182857330|SUPERIORITY||Treatment difference|32.51|STANDARD_ERROR_OF_MEAN|9.52||0.003|TWO_SIDED|95.0|12.67|52.35|||ANCOVA|||||52.35|12.67|0.003
91730804|NCT04770272|183356898|SUPERIORITY||Hazard Ratio (HR)|1.65||||0.495|TWO_SIDED|95.0|0.39|6.89|||Regression, Cox|||||6.89|0.39|0.495
91730805|NCT04770272|183356899|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.529|TWO_SIDED|95.0|0.64|2.38|||Regression, Cox|Univariable Cox Regression.||||2.38|0.64|0.529
91730806|NCT02363946|183356903|OTHER||alpha estimate|9.557|STANDARD_ERROR_OF_MEAN|0.037|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370||||
91730807|NCT02363946|183356903|OTHER||beta estimate|1.173|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|1.128|1.218|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|R-square (r\^2)=0.98|1.218|1.128|
91730808|NCT02363946|183356903|OTHER||alpha estimate|9.824|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP||||
91730809|NCT02363946|183356903|OTHER||beta estimate|1.103|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|1.054|1.153|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|R-square (r\^2)=0.98|1.153|1.054|
91730810|NCT02363946|183356905|OTHER||alpha estimate|11.274|STANDARD_ERROR_OF_MEAN|0.057|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370||||
91730811|NCT02363946|183356905|OTHER||beta estimate|1.181|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.112|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.112|
91492643|NCT03570697|182857331|SUPERIORITY||Treatment difference|-26.0|STANDARD_ERROR_OF_MEAN|11.4||0.032|TWO_SIDED|95.0|-49.6|-2.4|||ANCOVA|||||-2.4|-49.6|0.032
91492644|NCT03570697|182857332|SUPERIORITY||Treatment difference|16.0|STANDARD_ERROR_OF_MEAN|7.5||0.036|TWO_SIDED|95.0|1.1|31.0|||ANCOVA|||||31.0|1.1|0.036
91492645|NCT03570697|182857333|SUPERIORITY||Treatment difference|-30.0|STANDARD_ERROR_OF_MEAN|10.4||0.005|TWO_SIDED|95.0|-50.5|-9.5|||ANCOVA|||||-9.5|-50.5|0.005
91492646|NCT03570697|182857334|SUPERIORITY||Treatment difference|-2.43|STANDARD_ERROR_OF_MEAN|0.81||0.003|TWO_SIDED|95.0|-4.04|-0.82|||ANCOVA|||||-0.82|-4.04|0.003
91492647|NCT02571777|182857351|SUPERIORITY||LS Mean|0.065|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.031|0.099|||Mixed Model for Repeated Measures (MMRM)|||||0.099|0.031|<0.001
91492648|NCT02571777|182857351|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.041|0.111|||MMRM|||||0.111|0.041|<0.001
91492649|NCT02571777|182857352|SUPERIORITY||LS Mean|0.014|STANDARD_ERROR_OF_MEAN|0.0406||0.729|TWO_SIDED|95.0|-0.066|0.094|||MMRM|||Week 26||0.094|-0.066|0.729
91730812|NCT02363946|183356905|OTHER||alpha estimate|12.133|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP||||
91492650|NCT02571777|182857352|SUPERIORITY||LS Mean|-0.086|STANDARD_ERROR_OF_MEAN|0.0404||0.034|TWO_SIDED|95.0|-0.165|-0.006|||MMRM|||Week 26||-0.006|-0.165|0.034
91492651|NCT02571777|182857352|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.0409||0.085|TWO_SIDED|95.0|-0.151|0.01|||MMRM|||Week 26||0.010|-0.151|0.085
91492652|NCT02571777|182857352|SUPERIORITY||LS Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0406||0.038|TWO_SIDED|95.0|-0.164|-0.005|||MMRM|||Week 26||-0.005|-0.164|0.038
91492653|NCT02571777|182857352|SUPERIORITY||LS Mean|-0.059|STANDARD_ERROR_OF_MEAN|0.0415||0.157|TWO_SIDED|95.0|-0.14|0.023|||MMRM|||Week 52||0.023|-0.140|0.157
91492654|NCT02571777|182857352|SUPERIORITY||LS Mean|-0.121|STANDARD_ERROR_OF_MEAN|0.0414||0.003|TWO_SIDED|95.0|-0.202|-0.04|||MMRM|||Week 52||-0.040|-0.202|0.003
91730813|NCT02363946|183356905|OTHER||beta estimate|1.147|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.08|1.215|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|R-square (r\^2)=0.96|1.215|1.080|
91492655|NCT02571777|182857352|SUPERIORITY||LS Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.814|TWO_SIDED|95.0|-0.092|0.072|||MMRM|||Week 52||0.072|-0.092|0.814
91492656|NCT02571777|182857352|SUPERIORITY||LS Mean|0.008|STANDARD_ERROR_OF_MEAN|0.0416||0.845|TWO_SIDED|95.0|-0.073|0.09|||MMRM|||Week 52||0.090|-0.073|0.845
91730814|NCT02363946|183356906|OTHER||alpha estimate|11.286|STANDARD_ERROR_OF_MEAN|0.058|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370||||
91492657|NCT02571777|182857353|SUPERIORITY||LS Mean|0.119|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.085|0.154|||MMRM|||||0.154|0.085|<0.001
91492658|NCT02571777|182857353|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.064|0.133|||MMRM|||||0.133|0.064|<0.001
91492659|NCT02571777|182857354|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.051|0.12|||MMRM|||||0.120|0.051|<0.001
91492660|NCT02571777|182857354|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.111|0.18|||MMRM|||||0.180|0.111|<0.001
91492661|NCT02571777|182857354|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.027|0.096|||MMRM|||||0.096|0.027|<0.001
91730815|NCT02363946|183356906|OTHER||beta estimate|1.179|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED|95.0|1.11|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.110|
91492662|NCT02571777|182857354|SUPERIORITY||LS Mean|0.087|STANDARD_ERROR_OF_MEAN|0.0179|<|0.001|TWO_SIDED|95.0|0.052|0.122|||MMRM|||||0.122|0.052|<0.001
91492663|NCT02571777|182857355|SUPERIORITY||LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.03|0.116|||MMRM|||Week 4||0.116|0.030|<0.001
91492664|NCT02571777|182857355|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.096|0.181|||MMRM|||Week 4||0.181|0.096|<0.001
91492665|NCT02571777|182857355|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.022||0.074|TWO_SIDED|95.0|-0.004|0.082|||MMRM|||Week 4||0.082|-0.004|0.074
91492666|NCT02571777|182857355|SUPERIORITY||LS Mean|0.108|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.065|0.15|||MMRM|||Week 4||0.150|0.065|<0.001
91492667|NCT02571777|182857355|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0219||0.01|TWO_SIDED|95.0|0.014|0.099|||MMRM|||Week 12||0.099|0.014|0.010
91492668|NCT02571777|182857355|SUPERIORITY||LS Mean|0.102|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.059|0.145|||MMRM|||Week 12||0.145|0.059|<0.001
91492669|NCT02571777|182857355|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0221||0.022|TWO_SIDED|95.0|0.007|0.094|||MMRM|||Week 12||0.094|0.007|0.022
91492670|NCT02571777|182857355|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.056|0.142|||MMRM|||Week 12||0.142|0.056|<0.001
91492671|NCT02571777|182857356|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.0254|<|0.001|TWO_SIDED|95.0|0.045|0.145|||MMRM|||||0.145|0.045|<0.001
91492672|NCT02571777|182857356|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0256|<|0.001|TWO_SIDED|95.0|0.097|0.198|||MMRM|||||0.198|0.097|<0.001
91492673|NCT02571777|182857356|SUPERIORITY||LS Mean|0.049|STANDARD_ERROR_OF_MEAN|0.0256||0.057|TWO_SIDED|95.0|-0.001|0.099|||MMRM|||||0.099|-0.001|0.057
91492674|NCT02571777|182857356|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0258||0.029|TWO_SIDED|95.0|0.006|0.107|||MMRM|||||0.107|0.006|0.029
91492675|NCT02571777|182857357|SUPERIORITY||LS Mean|18.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|13.2|23.3|||Linear Mixed Model (LMM)|||Week 26 - Mean morning PEF||23.3|13.2|<0.001
91492676|NCT02571777|182857357|SUPERIORITY||LS Mean|35.3|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|30.2|40.3|||LMM|||Week 26 - Mean morning PEF||40.3|30.2|<0.001
91730816|NCT02363946|183356906|OTHER||alpha estimate|12.347|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP||||
91492677|NCT02571777|182857357|SUPERIORITY||LS Mean|14.9|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|9.8|20.0|||LMM|||Week 26 - Mean morning PEF||20.0|9.8|<0.001
91492678|NCT02571777|182857357|SUPERIORITY||LS Mean|28.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|22.9|33.1|||LMM|||Week 26 - Mean morning PEF||33.1|22.9|<0.001
91492679|NCT02571777|182857357|SUPERIORITY||LS Mean|16.8|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|11.8|21.7|||LMM|||Week 26 - Mean evening PEF||21.7|11.8|<0.001
91492680|NCT02571777|182857357|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|24.2|34.1|||LMM|||Week 26 - Mean evening PEF||34.1|24.2|<0.001
91492681|NCT02571777|182857357|SUPERIORITY||LS Mean|14.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|9.1|19.1|||LMM|||Week 26 - Mean evening PEF||19.1|9.1|<0.001
91492682|NCT02571777|182857357|SUPERIORITY||LS Mean|24.3|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|19.3|29.3|||LMM|||Week 26 - Mean evening PEF||29.3|19.3|<0.001
91699507|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6255
91699508|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0085
91699509|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0722|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0722
91699510|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3577|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3577
91699511|NCT02612610|183293911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
91699512|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3845|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3845
91699513|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1177|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1177
91699514|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0236|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0236
91699515|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0192|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0192
91492683|NCT02571777|182857357|SUPERIORITY||LS Mean|18.7|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|13.4|24.1|||LMM|||Week 52 - Mean morning PEF||24.1|13.4|<0.001
91492684|NCT02571777|182857357|SUPERIORITY||LS Mean|34.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|29.5|40.1|||LMM|||Week 52 - Mean morning PEF||40.1|29.5|<0.001
91492685|NCT02571777|182857357|SUPERIORITY||LS Mean|15.6|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|10.2|20.9|||LMM|||Week 52 - Mean morning PEF||20.9|10.2|<0.001
91492686|NCT02571777|182857357|SUPERIORITY||LS Mean|28.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|23.2|33.8|||LMM|||Week 52 - Mean morning PEF||33.8|23.2|<0.001
91492687|NCT02571777|182857357|SUPERIORITY||LS Mean|17.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|12.3|22.8|||LMM|||Week 52 - Mean evening PEF||22.8|12.3|<0.001
91492688|NCT02571777|182857357|SUPERIORITY||LS Mean|29.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|24.2|34.7|||LMM|||Week 52 - Mean evening PEF||34.7|24.2|<0.001
91492689|NCT02571777|182857357|SUPERIORITY||LS Mean|15.0|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|9.7|20.2|||LMM|||Week 52 - Mean evening PEF||20.2|9.7|<0.001
91492690|NCT02571777|182857357|SUPERIORITY||LS Mean|25.8|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|20.5|31.0|||LMM|||Week 52 - Mean evening PEF||31.0|20.5|<0.001
91492691|NCT02571777|182857358|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.81||0.907|TWO_SIDED|95.0|-3.3|3.8|||LMM|||||3.8|-3.3|0.907
91492692|NCT02571777|182857358|SUPERIORITY||LS Mean|3.5|STANDARD_ERROR_OF_MEAN|1.81||0.055|TWO_SIDED|95.0|-0.1|7.0|||LMM|||||7.0|-0.1|0.055
91699516|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3301|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3301
91492693|NCT02571777|182857358|SUPERIORITY||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.83||0.997|TWO_SIDED|95.0|-3.6|3.6|||LMM|||||3.6|-3.6|0.997
91492694|NCT02571777|182857358|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.82||0.606|TWO_SIDED|95.0|-4.5|2.6|||LMM|||||2.6|-4.5|0.606
91492695|NCT02571777|182857359|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.78||0.712|TWO_SIDED|95.0|-2.8|4.2|||LMM|||||4.2|-2.8|0.712
91492696|NCT02571777|182857359|SUPERIORITY||LS Mean|3.7|STANDARD_ERROR_OF_MEAN|1.78||0.038|TWO_SIDED|95.0|0.2|7.2|||LMM|||||7.2|0.2|0.038
91492697|NCT02571777|182857359|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.943|TWO_SIDED|95.0|-3.7|3.4|||LMM|||||3.4|-3.7|0.943
91492698|NCT02571777|182857359|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.79||0.612|TWO_SIDED|95.0|-4.4|2.6|||LMM|||||2.6|-4.4|0.612
91492699|NCT02571777|182857360|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.51||0.809|TWO_SIDED|95.0|-3.3|2.6|||LMM|||||2.6|-3.3|0.809
91492700|NCT02571777|182857360|SUPERIORITY||LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.5||0.467|TWO_SIDED|95.0|-1.9|4.0|||LMM|||||4.0|-1.9|0.467
91492701|NCT02571777|182857360|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.318|TWO_SIDED|95.0|-1.5|4.5|||LMM|||||4.5|-1.5|0.318
91492702|NCT02571777|182857360|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.51||0.64|TWO_SIDED|95.0|-2.3|3.7|||LMM|||||3.7|-2.3|0.640
91492703|NCT02571777|182857361|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.83||0.814|TWO_SIDED|95.0|-4.0|3.2|||LMM|||||3.2|-4.0|0.814
91492704|NCT02571777|182857361|SUPERIORITY||LS Mean|3.8|STANDARD_ERROR_OF_MEAN|1.83||0.036|TWO_SIDED|95.0|0.2|7.4|||LMM|||||7.4|0.2|0.036
91492705|NCT02571777|182857361|SUPERIORITY||LS Mean|3.1|STANDARD_ERROR_OF_MEAN|1.84||0.098|TWO_SIDED|95.0|-0.6|6.7|||LMM|||||6.7|-0.6|0.098
91492706|NCT02571777|182857361|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.84||0.118|TWO_SIDED|95.0|-0.7|6.5|||LMM|||||6.5|-0.7|0.118
91492707|NCT02571777|182857362|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
91492708|NCT02571777|182857362|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
91492709|NCT02571777|182857362|SUPERIORITY||LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
91492710|NCT02571777|182857362|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
91492711|NCT02571777|182857362|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
91492712|NCT02571777|182857362|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
91492713|NCT02571777|182857362|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
91492714|NCT02571777|182857362|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
91492715|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|0.92||||0.535|TWO_SIDED|95.0|0.7|1.2|||Logistic regression model|||Week 26||1.20|0.70|0.535
91492716|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|1.21||||0.151|TWO_SIDED|95.0|0.93|1.57|||Logistic regression model|||Week 26||1.57|0.93|0.151
91492717|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|1.13||||0.38|TWO_SIDED|95.0|0.86|1.48|||Logistic regression model|||Week 26||1.48|0.86|0.380
91492718|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|1.2||||0.172|TWO_SIDED|95.0|0.92|1.57|||Logistic regression model|||Week 26||1.57|0.92|0.172
91492719|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|1.1||||0.51|TWO_SIDED|95.0|0.83|1.47|||Logistic regression model|||Week 52||1.47|0.83|0.510
91492720|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|1.41||||0.017|TWO_SIDED|95.0|1.06|1.86|||Logistic regression model|||Week 52||1.86|1.06|0.017
91492721|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|1.05||||0.744|TWO_SIDED|95.0|0.79|1.38|||Logistic regression model|||Week 52||1.38|0.79|0.744
91492722|NCT02571777|182857363|SUPERIORITY||Odds Ratio (OR)|0.99||||0.922|TWO_SIDED|95.0|0.75|1.29|||Logistic regression model|||Week 52||1.29|0.75|0.922
91492723|NCT02571777|182857364|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.371|TWO_SIDED|95.0|0.27|1.63|||Regression, Cox|||||1.63|0.27|0.371
91492724|NCT02571777|182857364|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.996|TWO_SIDED|95.0|0.37|2.66|||Regression, Cox|||||2.66|0.37|0.996
91492725|NCT02571777|182857364|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.145|TWO_SIDED|95.0|0.8|4.47|||Regression, Cox|||||4.47|0.80|0.145
91492726|NCT02571777|182857364|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.15|TWO_SIDED|95.0|0.8|4.43|||Regression, Cox|||||4.43|0.80|0.150
91492727|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.523|TWO_SIDED|95.0|0.77|1.15|||Regression, Cox|||Moderate or severe asthma exacerbation||1.15|0.77|0.523
91492728|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Regression, Cox|||Moderate or severe asthma exacerbation||0.84|0.58|<0.001
91730817|NCT02363946|183356906|OTHER||beta estimate|1.163|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|1.081|1.245|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|R-square (r\^2)=0.95|1.245|1.081|
91730818|NCT05213624|183356929|OTHER||Odds Ratio (OR)|10.0|||||TWO_SIDED|95.0|1.59|118.14|||||BI 764198 (comparator) vs. Placebo (reference)|Logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates.||118.14|1.59|
91730819|NCT05213624|183356929|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|0.16|19.48|||||BI 764198 (comparator) vs. Placebo (reference)|Logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates.||19.48|0.16|
91730820|NCT05213624|183356929|OTHER||Odds Ratio (OR)|5.97|||||TWO_SIDED|95.0|0.86|73.57|||||BI 764198 (comparator) vs. Placebo (reference)|Logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates.||73.57|0.86|
91730821|NCT05213624|183356930|OTHER||Relative difference|-39.82||||0.0024|TWO_SIDED|95.0|-56.17|-17.36||Nominal and unadjusted|ANCOVA||"Comparison vs Placebo~Calculated as (exp(difference of least square means) - 1) \* 100."|An analysis of covariance (ANCOVA) model was used to estimate the change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates.||-17.36|-56.17|0.0024
91730822|NCT05213624|183356930|OTHER||Relative difference|-4.57||||0.7906|TWO_SIDED|95.0|-32.92|35.77||Nominal and unadjusted|ANCOVA||"Comparison vs Placebo~Calculated as (exp(difference of least square means) - 1) \* 100."|An analysis of covariance (ANCOVA) model was used to estimate the change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates.||35.77|-32.92|0.7906
91730823|NCT05213624|183356930|OTHER||Relative difference|-23.27||||0.1325|TWO_SIDED|95.0|-45.83|8.7||Nominal and unadjusted|ANCOVA||"Comparison vs Placebo~Calculated as (exp(difference of least square means) - 1) \* 100."|An analysis of covariance (ANCOVA) model was used to estimate the change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates.||8.70|-45.83|0.1325
91730824|NCT01602380|183356935|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.797||||0.0486|TWO_SIDED|95.0|0.637|0.999||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio \< 1 favours fulvestrant.|If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).||0.999|0.637|0.0486
91730825|NCT01602380|183356936|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.966||||0.7579|TWO_SIDED|95.0|0.773|1.206||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A HR of \<1 favours fulvestrant.|65% OS maturity||1.206|0.773|0.7579
91492729|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox|||Moderate or severe asthma exacerbation||1.06|0.72|0.164
91730826|NCT01602380|183356937|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.074||||0.729|TWO_SIDED|95.0|0.716|1.614||2-sided p-value|Regression, Logistic|||||1.614|0.716|0.7290
91730827|NCT01602380|183356939|SUPERIORITY_OR_OTHER_LEGACY||Rato of EDoR|1.52||||0.0367|TWO_SIDED|95.0|1.03|2.26||2-sided p-value|Method of Ellis et al|||||2.26|1.03|0.0367
91730828|NCT01602380|183356940|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.253||||0.3045|TWO_SIDED|95.0|0.815|1.932||2-sided p-value|Regression, Logistic|||||1.932|0.815|0.3045
91730829|NCT01602380|183356942|SUPERIORITY_OR_OTHER_LEGACY||Ratio of EDoCB|1.26||||0.0561||95.0|0.99|1.59||2-sided p-value|Method of Ellis et al|||||1.59|0.99|0.0561
91730830|NCT01602380|183356943|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.2846|TWO_SIDED|95.0|0.7|1.11||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).||1.11|0.70|0.2846
91730831|NCT01602380|183356943|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0844|TWO_SIDED|95.0|0.66|1.03||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).||1.03|0.66|0.0844
91730832|NCT00787800|183356968|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Log Rank|||||||1.0
91730833|NCT00787800|183356970|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.050
91730834|NCT00787800|183356972|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91730835|NCT03369704|183356977|OTHER||Least Square Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.44|-0.62||"H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.~H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period."|ANCOVA||nasal symptom score|||-0.62|-1.44|<0.001
91730836|NCT03369704|183356978|OTHER||ANCOVA|-1.89|STANDARD_ERROR_OF_MEAN|0.331|||TWO_SIDED|95.0|-2.55|-1.24|||||Nasal Ocular Symptom|||-1.24|-2.55|
91730837|NCT03369704|183356978|OTHER||ANCOVA|-0.87|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-1.18|-0.55|||||Ocular symptom|||-0.55|-1.18|
91492730|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.005|TWO_SIDED|95.0|0.63|0.92|||Regression, Cox|||Moderate or severe asthma exacerbation||0.92|0.63|0.005
91730838|NCT03369704|183356979|OTHER||ANCOVA|-1.1|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|95.0|-1.55|-0.64|||||nasal symptom medication score|||-0.64|-1.55|
91730839|NCT03369704|183356979|OTHER||ANCOVA|-0.95|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-1.32|-0.58|||||ocular symptom medication score|||-0.58|-1.32|
91730840|NCT03369704|183356979|OTHER||ANCOVA|-2.05|STANDARD_ERROR_OF_MEAN|0.375|||TWO_SIDED|95.0|-2.78|-1.31|||||nasal ocular symptom medication score|||-1.31|-2.78|
91730841|NCT03369704|183356980|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.073|||TWO_SIDED|95.0|-0.54|-0.26|||||sneezing score|||-0.26|-0.54|
91730842|NCT03369704|183356980|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|95.0|-0.51|-0.16|||||rhinorrhea score|||-0.16|-0.51|
91730843|NCT03369704|183356980|OTHER||ANCOVA|-0.29|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|-0.45|-0.13|||||nasal congestion score|||-0.13|-0.45|
91730844|NCT03369704|183356981|OTHER||ANCOVA|-0.47|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|95.0|-0.63|-0.3|||||itchy eye score|||-0.30|-0.63|
91492731|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.476|TWO_SIDED|95.0|0.72|1.16|||Regression, Cox|||Severe asthma exacerbation||1.16|0.72|0.476
91492732|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.54|0.85|||Regression, Cox|||Severe asthma exacerbation||0.85|0.54|<0.001
91492733|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.243|TWO_SIDED|95.0|0.7|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.70|0.243
91492734|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.027|TWO_SIDED|95.0|0.63|0.97|||Regression, Cox|||Severe asthma exacerbation||0.97|0.63|0.027
91492735|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.497|TWO_SIDED|95.0|0.79|1.12|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.12|0.79|0.497
91730845|NCT03369704|183356981|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.57|-0.23|||||watery eye score|||-0.23|-0.57|
91492736|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.84|0.60|<0.001
91730846|NCT03369704|183356982|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.48|-0.2|||||score for impairment of daily activities|||-0.20|-0.48|
91730847|NCT03369704|183356983|OTHER||Hodges-Lehmann Estimate|3.0|STANDARD_ERROR_OF_MEAN|1.02||0.005|TWO_SIDED|95.0|1.0|5.0|||van Elteren test||Nasal symptom free days|||5.0|1.0|0.005
91492737|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.126|TWO_SIDED|95.0|0.73|1.04|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.04|0.73|0.126
91492738|NCT02571777|182857365|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.61|0.85|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.85|0.61|<0.001
91492739|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.85||||0.12|TWO_SIDED|95.0|0.68|1.04|||Generalized linear model|||Moderate or severe asthma exacerbation||1.04|0.68|0.120
91492740|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.52|0.78|||Generalized linear model|||Moderate or severe asthma exacerbation||0.78|0.52|<0.001
91492741|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06|||Generalized linear modeñ|||Moderate or severe asthma exacerbation||1.06|0.71|0.170
91492742|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.81||||0.041|TWO_SIDED|95.0|0.66|0.99|||Generalized linear model|||Moderate or severe asthma exacerbation||0.99|0.66|0.041
91492743|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.78||||0.05|TWO_SIDED|95.0|0.61|1.0|||Generalized linear model|||Severe asthma exacerbation||1.00|0.61|0.050
91492744|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||Generalized linear model|||Severe asthma exacerbation||0.73|0.45|<0.001
91492745|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.93||||0.531|TWO_SIDED|95.0|0.74|1.17|||Generalized linear model|||Severe asthma exacerbation||1.17|0.74|0.531
91492746|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Linear generalized model|||Severe asthma exacerbation||1.05|0.67|0.117
91730848|NCT03369704|183356983|OTHER||Hodges-Lehmann Estimate|4.0|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.0|6.5|||van Elteren test||Ocular symptom free days|||6.5|2.0|<0.001
91730849|NCT03369704|183356984|OTHER||Odds Ratio (OR)|3.43||||0.005|TWO_SIDED|95.0|1.21|9.75|||logistic regression||Completely nasal symptom free patients|||9.75|1.21|0.005
91730850|NCT03369704|183356985|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.14|-0.01|||||Nasal rescue mediation score|||-0.01|-0.14|
91730851|NCT03369704|183356985|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.16|0.0|||||Ocular rescue medication score|||0.00|-0.16|
91730852|NCT03369704|183356985|OTHER||ANCOVA|-0.16|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.28|-0.04|||||Nasal ocular rescue medication score|||-0.04|-0.28|
91730853|NCT03369704|183356986|OTHER||Hodges-Lehmann Estimate|1.5|STANDARD_ERROR_OF_MEAN|0.89||0.011|TWO_SIDED|95.0|0.0|3.5|||van Elteren test||Nasal rescue mediation free days|||3.5|0.0|0.011
91492747|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.79||||0.016|TWO_SIDED|95.0|0.66|0.96|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.96|0.66|0.016
91492748|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.72|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.72|0.50|<0.001
91492749|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.87||||0.161|TWO_SIDED|95.0|0.72|1.06|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.06|0.72|0.161
91492750|NCT02571777|182857366|SUPERIORITY||Rate ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.84|0.58|<0.001
91492751|NCT02571777|182857367|SUPERIORITY|||||||0.183|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.183
91492752|NCT02571777|182857367|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
91492753|NCT02571777|182857367|SUPERIORITY|||||||0.155|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.155
91492754|NCT02571777|182857367|SUPERIORITY|||||||0.007|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.007
91492755|NCT02571777|182857367|SUPERIORITY|||||||0.172|||||||van Elteren test|||Severe asthma exacerbation||||0.172
91492756|NCT02571777|182857367|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Severe asthma exacerbation||||<0.001
91492757|NCT02571777|182857367|SUPERIORITY|||||||0.241|||||||van Elteren test|||Severe asthma exacerbation||||0.241
91492758|NCT02571777|182857367|SUPERIORITY|||||||0.033|||||||van Elteren test|||Severe asthma exacerbation||||0.033
91492759|NCT02571777|182857367|SUPERIORITY|||||||0.095|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.095
91492760|NCT02571777|182857367|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
91492761|NCT02571777|182857367|SUPERIORITY|||||||0.09|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.090
91492762|NCT02571777|182857367|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
91492763|NCT02571777|182857369|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.314|TWO_SIDED|95.0|0.12|1.96|||Regression, Cox|||||1.96|0.12|0.314
91699517|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0008
91699518|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0285|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0285
91699519|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3856|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3856
91699520|NCT02612610|183293912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
91699521|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2441|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2441
91699522|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5055|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5055
91699523|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
91699524|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2721|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2721
91699525|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9763|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9763
91699526|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
91699527|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4575|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4575
91492764|NCT02571777|182857369|SUPERIORITY||Hazard Ratio (HR)|0.28||||0.055|TWO_SIDED|95.0|0.08|1.03|||Regression, Cox|||||1.03|0.08|0.055
91492765|NCT02571777|182857369|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.306|TWO_SIDED|95.0|0.25|1.54|||Regression, Cox|||||1.54|0.25|0.306
91492766|NCT02571777|182857369|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.566|TWO_SIDED|95.0|0.3|1.94|||Regression, Cox|||||1.94|0.30|0.566
91699528|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9706|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9706
91730854|NCT03369704|183356986|OTHER||Hodges-Lehmann Estimate|2.0|STANDARD_ERROR_OF_MEAN|1.21||0.074|TWO_SIDED|95.0|0.0|4.8|||van Elteren test||Ocular rescue medication free days|||4.8|0.0|0.074
91699529|NCT02612610|183293913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3258|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3258
91492767|NCT02571777|182857371|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
91492768|NCT02571777|182857371|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
91492769|NCT02571777|182857371|SUPERIORITY||LMM|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
91492770|NCT02571777|182857371|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
91492771|NCT02571777|182857371|SUPERIORITY||LMM|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
91492772|NCT02571777|182857371|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
91699530|NCT02612610|183293914|OTHER||LS Mean Difference|0.0||||0.9858|TWO_SIDED|95.0|-0.53|0.54|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.54|-0.53|0.9858
91699531|NCT02612610|183293914|OTHER||LS Mean Difference|-0.01||||0.9813|TWO_SIDED|95.0|-0.53|0.52|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.52|-0.53|0.9813
91699532|NCT02612610|183293914|OTHER||LS Mean Difference|-0.11||||0.6746|TWO_SIDED|95.0|-0.65|0.42|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.42|-0.65|0.6746
91699533|NCT02612610|183293915|OTHER||LS Mean Difference|-0.32||||0.2583|TWO_SIDED|95.0|-0.88|0.24|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.24|-0.88|0.2583
91699534|NCT02612610|183293915|OTHER||LS Mean Difference|0.01||||0.9826|TWO_SIDED|95.0|-0.55|0.56|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.56|-0.55|0.9826
91699535|NCT02612610|183293915|OTHER||LS Mean Difference|-0.4||||0.1672|TWO_SIDED|95.0|-0.98|0.17|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.17|-0.98|0.1672
91699536|NCT02612610|183293916|OTHER||LS Mean Difference|0.14||||0.6102|TWO_SIDED|95.0|-0.4|0.68|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.68|-0.4|0.6102
91492773|NCT02571777|182857371|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
91492774|NCT02571777|182857371|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
91492775|NCT02571777|182857372|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.0502||0.69|TWO_SIDED|95.0|-0.078|0.118|||MMRM|||||0.118|-0.078|0.690
91492776|NCT02571777|182857372|SUPERIORITY||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.0502||0.232|TWO_SIDED|95.0|-0.038|0.159|||MMRM|||||0.159|-0.038|0.232
91492777|NCT02571777|182857372|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0506||0.285|TWO_SIDED|95.0|-0.153|0.045|||MMRM|||||0.045|-0.153|0.285
91492778|NCT02571777|182857372|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.0505||0.319|TWO_SIDED|95.0|-0.15|0.049|||MMRM|||||0.049|-0.150|0.319
91699537|NCT02612610|183293916|OTHER||LS Mean Difference|0.08||||0.7782|TWO_SIDED|95.0|-0.46|0.61|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.61|-0.46|0.7782
91699538|NCT02612610|183293916|OTHER||LS Mean Difference|0.28||||0.3167|TWO_SIDED|95.0|-0.27|0.83|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.83|-0.27|0.3167
91492779|NCT02571777|182857373|SUPERIORITY||LS Mean|0.068|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.036|0.101|||MMRM|||Week 4||0.101|0.036|<0.001
91492780|NCT02571777|182857373|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0165|<|0.001|TWO_SIDED|95.0|0.113|0.177|||MMRM|||Week 4||0.177|0.113|<0.001
91492781|NCT02571777|182857373|SUPERIORITY||LS Mean|0.033|STANDARD_ERROR_OF_MEAN|0.0167||0.049|TWO_SIDED|95.0|0.0|0.066|||MMRM|||Week 4||0.066|0.000|0.049
91492782|NCT02571777|182857373|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.064|0.129|||MMRM|||Week 4||0.129|0.064|<0.001
91699539|NCT02612610|183293917|OTHER||LS Mean Difference|0.3||||0.1545|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.1545
91699540|NCT02612610|183293917|OTHER||LS Mean Difference|0.3||||0.2013|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.2013
91730855|NCT03369704|183356986|OTHER||Hodges-Lehmann Estimate|1.8|STANDARD_ERROR_OF_MEAN|1.02||0.098|TWO_SIDED|95.0|0.0|4.0|||van Elteren test||Nasal ocular rescue medication free days|||4.0|0.0|0.098
91492783|NCT02571777|182857373|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0184||0.002|TWO_SIDED|95.0|0.022|0.094|||MMRM|||Week 12||0.094|0.022|0.002
91535598|NCT00991276|182949768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.45|STANDARD_ERROR_OF_MEAN|5.27|<|0.0001|TWO_SIDED|95.0|-38.89|-18.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.02|-38.89|<0.0001
91730856|NCT03369704|183356987|OTHER||Hodges-Lehmann Estimate|-2.0|STANDARD_ERROR_OF_MEAN|1.15||0.006|TWO_SIDED|95.0|-4.5|0.0|||van Elteren test||Nasal rescue mediation used|||0.0|-4.5|0.006
91730857|NCT03369704|183356987|OTHER||Hodges-Lehmann Estimate|-7.0|STANDARD_ERROR_OF_MEAN|2.81||0.012|TWO_SIDED|95.0|-12.0|-1.0|||van Elteren test||Ocular rescue medication used|||-1.0|-12.0|0.012
91730858|NCT03369704|183356988|OTHER||ANCOVA|-0.5|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|-0.66|-0.33|||||JRQLQ I|||-0.33|-0.66|
91492784|NCT02571777|182857373|SUPERIORITY||LS Mean|0.117|STANDARD_ERROR_OF_MEAN|0.0183|<|0.001|TWO_SIDED|95.0|0.081|0.153|||MMRM|||Week 12||0.153|0.081|<0.001
91492785|NCT02571777|182857373|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0185||0.007|TWO_SIDED|95.0|0.013|0.086|||MMRM|||Week 12||0.086|0.013|0.007
91492786|NCT02571777|182857373|SUPERIORITY||MMRM|0.087|STANDARD_ERROR_OF_MEAN|0.0184|<|0.001|TWO_SIDED|95.0|0.051|0.123|||MMRM|||Week 12||0.123|0.051|<0.001
91492787|NCT03652012|182857376|SUPERIORITY||Mean Difference (Final Values)|54.2||||0.044|TWO_SIDED|95.0|1.54|106.85||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference (Healthy Controls - MCI).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure."||106.85|1.54|0.044
91492788|NCT03652012|182857376|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.912|TWO_SIDED|95.0|-51.87|57.47||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference in slope of the stimulus-response curve by muscle contraction condition (Active - Rest).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.~The results presented here reflect the main effect of Condition on the slope of the stimulus-response curve."||57.47|-51.87|0.912
91492789|NCT03652012|182857377|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.1021|TWO_SIDED|95.0|-4.33|45.54|||t-test, 2 sided|No adjustment for multiple comparisons.|Mean cortical silent period (CSP; units = milliseconds) in the CN group minus mean CSP in the MCI group. Positive values indicate a longer cortical silent period in the control group.|||45.54|-4.33|0.1021
91492790|NCT03652012|182857378|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.19|TWO_SIDED|95.0|-0.113|0.529|||t-test, 2 sided|||||0.529|-0.113|0.19
91492791|NCT03652012|182857379|SUPERIORITY||Mean Difference (Net)|0.0078||||0.97|TWO_SIDED|95.0|-0.51|0.5|||t-test, 2 sided|||||0.50|-0.51|0.97
91492792|NCT01288235|182857380|OTHER||3-Year Cumulative incidence|14.5|||||TWO_SIDED|95.0|8.3|22.3||||||||22.3|8.3|
91492793|NCT01288235|182857380|OTHER||5-Year Cumulative incidence|20.2|||||TWO_SIDED|95.0|12.7|28.9||||||||28.9|12.7|
91492794|NCT01288235|182857381|OTHER||Mean Difference (Net)|1.1||||0.543|TWO_SIDED|95.0|-2.6|4.9|||t-test, 2 sided|Paired t test||||4.9|-2.6|0.543
91492795|NCT01288235|182857382|OTHER||3-Year Local Disease Control Probability|89.9|||||TWO_SIDED|95.0|83.1|94.9||||||||94.9|83.1|
91492796|NCT01288235|182857382|OTHER||5-Year Local Disease Control Probability|85.9|||||TWO_SIDED|95.0|78.2|91.9||||||||91.9|78.2|
91730859|NCT03369704|183356988|OTHER||ANCOVA|-0.51|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|-0.69|-0.33|||||JRQLQ II|||-0.33|-0.69|
91730860|NCT03369704|183356988|OTHER||ANCOVA|-0.6|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.8|-0.4|||||JRQLQ III|||-0.4|-0.8|
91759158|NCT04038567|183411363|SUPERIORITY||Mean Difference (Final Values)|-1.47|||||TWO_SIDED|95.0|-2.81|-0.14||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.14|-2.81|
91535599|NCT00991276|182949768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|5.19||0.5461|TWO_SIDED|95.0|-7.13|13.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||13.40|-7.13|0.5461
91699541|NCT02612610|183293917|OTHER||LS Mean Difference|0.0||||0.9962|TWO_SIDED|95.0|-0.4|0.4|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.4|0.9962
91699542|NCT02612610|183293918|OTHER||LS Mean Difference|0.1||||0.7328|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7328
91699543|NCT02612610|183293918|OTHER||LS Mean Difference|0.1||||0.7635|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7635
91699544|NCT02612610|183293918|OTHER||LS Mean Difference|-0.4||||0.0951|TWO_SIDED|95.0|-0.9|0.1|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-0.9|0.0951
91699545|NCT02612610|183293919|OTHER||LS Mean Difference|-0.2||||0.5797|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5797
91699546|NCT02612610|183293919|OTHER||LS Mean Difference|-0.3||||0.2499|TWO_SIDED|95.0|-0.9|0.2|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-0.9|0.2499
91699547|NCT02612610|183293919|OTHER||LS Mean Difference|-0.5||||0.0612|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0612
91699548|NCT02612610|183293920|OTHER||LS Mean Difference|-0.2||||0.5358|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5358
91699549|NCT02612610|183293920|OTHER||LS Mean Difference|-0.3||||0.3129|TWO_SIDED|95.0|-0.8|0.3|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.8|0.3129
91699550|NCT02612610|183293920|OTHER||LS Mean Difference|-0.5||||0.1046|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1046
91699551|NCT02612610|183293921|OTHER||LS Mean Difference|-0.2||||0.5796|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5796
91699552|NCT02612610|183293921|OTHER||LS Mean Difference|-0.4||||0.143|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1430
91699553|NCT02612610|183293921|OTHER||LS Mean Difference|-0.7||||0.0221|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0221
91730861|NCT06401551|183356992|NON_INFERIORITY|Study success will be concluded if the upper bound of the one-sided 95.1% confidence interval does not exceed the noninferiority margin of 0.1 logMAR.|Difference in Means|-0.026|STANDARD_ERROR_OF_MEAN|0.0123|||ONE_SIDED|95.1||-0.0055||The upper boundary of the confidence interval is reported instead of a p-value.|t-test, 1 sided|The upper bound of the one-sided 95.1% confidence limit will be compared to the margin, 0.10 logMAR.|Difference in Means = CPO Pro IOL minus CPO|||-0.0055||
91730862|NCT02037984|183357017|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
91730863|NCT02037984|183357017|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.22|||||TWO_SIDED|95.0|1.64|3.02||||||||3.02|1.64|
91492797|NCT01288235|182857382|OTHER||3-Year Distant Disease Control|97.0|||||TWO_SIDED|95.0|92.1|99.2||||||||99.2|92.1|
91699554|NCT02612610|183293922|OTHER||LS Mean Difference|-0.4||||0.1562|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1562
91492798|NCT01288235|182857382|OTHER||5-Year Distant Disease Control|95.0|||||TWO_SIDED|95.0|89.4|98.1||||||||98.1|89.4|
91699555|NCT02612610|183293922|OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0710
91699556|NCT02612610|183293922|OTHER||LS Mean Difference|-0.7||||0.0274|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0274
91699557|NCT02612610|183293923|OTHER||LS Mean Difference|-0.2||||0.4464|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4464
91699558|NCT02612610|183293923|OTHER||LS Mean Difference|-0.3||||0.332|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.3320
91699559|NCT02612610|183293923|OTHER||LS Mean Difference|-0.5||||0.0792|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.0792
91699560|NCT02612610|183293924|OTHER||LS Mean Difference|-0.2||||0.4716|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4716
91699561|NCT02612610|183293924|OTHER||LS Mean Difference|-0.2||||0.4371|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4371
91699562|NCT02612610|183293924|OTHER||LS Mean Difference|-0.4||||0.1907|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1907
91730864|NCT02037984|183357017|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.37|||||TWO_SIDED|95.0|1.01|1.84||||||||1.84|1.01|
91730865|NCT02037984|183357017|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.71|||||TWO_SIDED|95.0|0.48|1.05||||||||1.05|0.48|
91730866|NCT02037984|183357017|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.6|||||TWO_SIDED|95.0|0.32|1.13||||||||1.13|0.32|
91730867|NCT02037984|183357017|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.34|||||TWO_SIDED|95.0|0.16|0.73||||||||0.73|0.16|
91730868|NCT02037984|183357017|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.72|||||TWO_SIDED|95.0|0.51|1.02||||||||1.02|0.51|
91730869|NCT02037984|183357017|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||||1.08|0.51|
91492799|NCT01288235|182857383|OTHER||3-Year Cumulative incidence of grade 3+|12.2|||||TWO_SIDED|95.0|6.6|19.5||||||||19.5|6.6|
91492800|NCT01288235|182857383|OTHER||5-Year Cumulative incidence of grade 3+|16.3|||||TWO_SIDED|95.0|9.8|24.3||||||||24.3|9.8|
91492801|NCT01288235|182857384|OTHER||3-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
91492802|NCT01288235|182857384|OTHER||5-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
91492803|NCT00113022|182857418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|18.867||0.919|TWO_SIDED|95.0|-46.565|51.006||The test reported here examines the main effect for placebo versus drug.|Mixed Models Analysis||A positive value indicates greater depression in the active treatment group compared to placebo.|Per protocol, a linear mixed model with a first order autoregressive covariance structure was used. Baseline was included as a covariate. Drug and visit were main effects with an interaction between them included.||51.006|-46.565|.919
91492804|NCT02021773|182857420|SUPERIORITY||Mean Difference (Final Values)|-22.74|STANDARD_ERROR_OF_MEAN|10.937||0.0386|TWO_SIDED|95.0|-44.28|-1.21||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.21|-44.28|0.0386
91492805|NCT02021773|182857420|SUPERIORITY||Mean Difference (Final Values)|-30.41|STANDARD_ERROR_OF_MEAN|10.9||0.0057|TWO_SIDED|95.0|-51.88|-8.95||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-8.95|-51.88|0.0057
91492806|NCT00191139|182857467|SUPERIORITY_OR_OTHER||survival rate|40.6||||||95.0|23.8|56.8|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||56.8|23.8|
91730870|NCT02037984|183357017|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||||0.90|0.39|
91730871|NCT02037984|183357017|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.31||||||||1.31|0.64|
91492807|NCT00191139|182857467|SUPERIORITY_OR_OTHER||survival rate|55.7||||||95.0|36.8|70.9|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||70.9|36.8|
91528590|NCT02294474|182932899|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 \& Humalog\>-0.3%.|Least Square (LS) Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.215|0.067|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.067|-0.215|
91528591|NCT02041923|182932928|EQUIVALENCE|A t-test was conducted to evaluate equivalency.|Mean Difference (Net)|46.3|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91528592|NCT02023879|182932950|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-56.4|||<|0.0001|TWO_SIDED|95.0|-62.9|-49.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.||-49.9|-62.9|<0.0001
91699563|NCT02612610|183293925|OTHER||LS Mean Difference|-0.3||||0.2772|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.2772
91699564|NCT02612610|183293925|OTHER||LS Mean Difference|-0.5||||0.1132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.1132
91699565|NCT02612610|183293925|OTHER||LS Mean Difference|-0.6||||0.0737|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0737
91699566|NCT02612610|183293926|OTHER||LS Mean Difference|-0.1||||0.6266|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6266
91699567|NCT02612610|183293926|OTHER||LS Mean Difference|-0.4||||0.1769|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1769
91699568|NCT02612610|183293926|OTHER||LS Mean Difference|-0.7||||0.0313|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.3|0.0313
91699569|NCT02612610|183293927|OTHER||LS Mean Difference|-0.4||||0.2058|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.2058
91699570|NCT02612610|183293927|OTHER||LS Mean Difference|-0.6||||0.0665|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0665
91730872|NCT02037984|183357017|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.61|1.27||||||||1.27|0.61|
91730873|NCT02037984|183357017|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.22|||||TWO_SIDED|95.0|0.83|1.78||||||||1.78|0.83|
91730874|NCT02037984|183357017|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.91|||||TWO_SIDED|95.0|0.57|1.45||||||||1.45|0.57|
91492808|NCT00191139|182857468|SUPERIORITY_OR_OTHER||Response Rate|75.0||||||95.0|56.6|88.5|||normal approximation|||||88.5|56.6|
91730875|NCT02037984|183357017|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|67.5|||||TWO_SIDED|95.0|45.58|99.97||||||||99.97|45.58|
91730876|NCT02037984|183357017|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|23.9|||||TWO_SIDED|95.0|13.21|43.24||||||||43.24|13.21|
91730877|NCT02037984|183357018|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.52|||||TWO_SIDED|95.0|0.39|0.7||||||||0.70|0.39|
91730878|NCT02037984|183357018|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|1.79|||||TWO_SIDED|95.0|1.33|2.41||||||||2.41|1.33|
91492809|NCT00191139|182857468|SUPERIORITY_OR_OTHER||Response rate|84.4||||||95.0|67.2|94.7|||Normal approximation|||||94.7|67.2|
91492810|NCT00191139|182857469|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Log Rank|||||||0.08
91492811|NCT00191139|182857470|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Log Rank|||||||0.38
91492812|NCT01817530|182857475|SUPERIORITY||Odds Ratio (OR)|32.51|||<|0.001|TWO_SIDED|95.0|11.12|95.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||95.05|11.12|< 0.001
91730879|NCT02037984|183357018|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.87|||||TWO_SIDED|95.0|0.65|1.16||||||||1.16|0.65|
91730880|NCT02037984|183357018|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.35|0.74||||||||0.74|0.35|
91730881|NCT02037984|183357018|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.31|||||TWO_SIDED|95.0|0.17|0.58||||||||0.58|0.17|
91730882|NCT02037984|183357018|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.16|||||TWO_SIDED|95.0|0.08|0.34||||||||0.34|0.08|
91730883|NCT02037984|183357018|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.48|||||TWO_SIDED|95.0|0.34|0.67||||||||0.67|0.34|
91730884|NCT02037984|183357018|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.56|||||TWO_SIDED|95.0|0.39|0.82||||||||0.82|0.39|
91730885|NCT02037984|183357018|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||||0.97|0.42|
91730886|NCT02037984|183357018|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
91730887|NCT02037984|183357018|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
91730888|NCT02037984|183357018|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.11|||||TWO_SIDED|95.0|0.77|1.6||||||||1.60|0.77|
91730889|NCT02037984|183357018|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.68|||||TWO_SIDED|95.0|0.43|1.07||||||||1.07|0.43|
91730890|NCT02037984|183357018|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|44.61|||||TWO_SIDED|95.0|30.42|65.43||||||||65.43|30.42|
91730891|NCT02037984|183357018|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.29|||||TWO_SIDED|95.0|8.58|27.26||||||||27.26|8.58|
91730892|NCT02037984|183357019|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.07||||||||1.07|0.57|
91730893|NCT02037984|183357019|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.68|||||TWO_SIDED|95.0|1.95|3.68||||||||3.68|1.95|
91730894|NCT02037984|183357019|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.52|||||TWO_SIDED|95.0|1.11|2.07||||||||2.07|1.11|
91730895|NCT02037984|183357019|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.02||||||||1.02|0.46|
91730896|NCT02037984|183357019|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.33|||||TWO_SIDED|95.0|0.17|0.64||||||||0.64|0.17|
91730897|NCT02037984|183357019|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.11|||||TWO_SIDED|95.0|0.05|0.23||||||||0.23|0.05|
91730898|NCT02037984|183357019|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.73|||||TWO_SIDED|95.0|0.51|1.04||||||||1.04|0.51|
91730899|NCT02037984|183357019|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||||1.30|0.59|
91730900|NCT02037984|183357019|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|1.03|||||TWO_SIDED|95.0|0.66|1.6||||||||1.60|0.66|
91730901|NCT02037984|183357019|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.96|||||TWO_SIDED|95.0|0.66|1.39||||||||1.39|0.66|
91730902|NCT02037984|183357019|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.64|1.39||||||||1.39|0.64|
91730903|NCT02037984|183357019|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.24|||||TWO_SIDED|95.0|0.84|1.84||||||||1.84|0.84|
91730904|NCT02037984|183357019|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
91730905|NCT02037984|183357019|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|77.57|||||TWO_SIDED|95.0|51.6|116.6||||||||116.60|51.60|
91730906|NCT02037984|183357019|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.66|||||TWO_SIDED|95.0|8.46|28.98||||||||28.98|8.46|
91730907|NCT02037984|183357020|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.93||||||||0.93|0.50|
91730908|NCT02037984|183357020|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.21|||||TWO_SIDED|95.0|1.62|3.02||||||||3.02|1.62|
91730909|NCT02037984|183357020|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||||1.31|0.71|
91730910|NCT02037984|183357020|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79||||||||0.79|0.36|
91730911|NCT02037984|183357020|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.49|||||TWO_SIDED|95.0|0.26|0.94||||||||0.94|0.26|
91730912|NCT02037984|183357020|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.36|||||TWO_SIDED|95.0|0.17|0.77||||||||0.77|0.17|
91730913|NCT02037984|183357020|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.6|||||TWO_SIDED|95.0|0.42|0.85||||||||0.85|0.42|
91730914|NCT02037984|183357020|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.54|1.16||||||||1.16|0.54|
91730915|NCT02037984|183357020|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.48|1.14||||||||1.14|0.48|
91730916|NCT02037984|183357020|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
91730917|NCT02037984|183357020|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.02||||||||1.02|0.48|
91730918|NCT02037984|183357020|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.88|||||TWO_SIDED|95.0|0.6|1.29||||||||1.29|0.60|
91730919|NCT02037984|183357020|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.43|1.12||||||||1.12|0.43|
91730920|NCT02037984|183357020|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|56.08|||||TWO_SIDED|95.0|37.66|83.52||||||||83.52|37.66|
91730921|NCT02037984|183357020|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|25.75|||||TWO_SIDED|95.0|14.18|46.78||||||||46.78|14.18|
91730922|NCT02037984|183357021|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09||||||||1.09|0.58|
91730923|NCT02037984|183357021|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.55|||||TWO_SIDED|95.0|1.86|3.49||||||||3.49|1.86|
91730924|NCT02037984|183357021|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
91730925|NCT02037984|183357021|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.34|0.76||||||||0.76|0.34|
91730926|NCT02037984|183357021|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.34|||||TWO_SIDED|95.0|0.17|0.65||||||||0.65|0.17|
91730927|NCT02037984|183357021|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.18|||||TWO_SIDED|95.0|0.08|0.38||||||||0.38|0.08|
91730928|NCT02037984|183357021|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.59|||||TWO_SIDED|95.0|0.41|0.84||||||||0.84|0.41|
91699571|NCT02612610|183293927|OTHER||LS Mean Difference|-0.8||||0.0155|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0155
91492813|NCT01817530|182857475|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492814|NCT01817530|182857475|SUPERIORITY||Odds Ratio (OR)|16.66|||<|0.001|TWO_SIDED|95.0|6.72|41.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||41.3|6.72|< 0.001
91492815|NCT01817530|182857475|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91699572|NCT02612610|183293928|OTHER||LS Mean Difference|-0.4||||0.2458|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2458
91699573|NCT02612610|183293928|OTHER||LS Mean Difference|-0.6||||0.0662|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0662
91699574|NCT02612610|183293928|OTHER||LS Mean Difference|-0.7||||0.0197|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0197
91699575|NCT02612610|183293929|OTHER||LS Mean Difference|0.3||||0.1921|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.1921
91699576|NCT02612610|183293929|OTHER||LS Mean Difference|0.3||||0.2428|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.2428
91699577|NCT02612610|183293929|OTHER||LS Mean Difference|-0.1||||0.7383|TWO_SIDED|95.0|-0.6|0.4|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.6|0.7383
91699578|NCT02612610|183293930|OTHER||LS Mean Difference|0.3||||0.4033|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4033
91699579|NCT02612610|183293930|OTHER||LS Mean Difference|0.2||||0.4599|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4599
91699580|NCT02612610|183293930|OTHER||LS Mean Difference|-0.3||||0.2837|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2837
91699581|NCT02612610|183293931|OTHER||LS Mean Difference|0.1||||0.8084|TWO_SIDED|95.0|-0.6|0.8|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.6|0.8084
91699582|NCT02612610|183293931|OTHER||LS Mean Difference|-0.2||||0.6108|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6108
91699583|NCT02612610|183293931|OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4220
91699584|NCT02612610|183293932|OTHER||LS Mean Difference|-0.1||||0.8457|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.8457
91699585|NCT02612610|183293932|OTHER||LS Mean Difference|-0.3||||0.4044|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4044
91492816|NCT01817530|182857475|SUPERIORITY||Odds Ratio (OR)|11.13|||<|0.001|TWO_SIDED|95.0|4.79|25.84||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||25.84|4.79|< 0.001
91492817|NCT01817530|182857475|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492818|NCT01817530|182857475|SUPERIORITY||Odds Ratio (OR)|19.62|||<|0.001|TWO_SIDED|95.0|7.81|49.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||49.27|7.81|< 0.001
91528593|NCT02023879|182932951|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.7|||<|0.0001|TWO_SIDED|95.0|-65.6|-53.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-53.8|-65.6|<0.0001
91528594|NCT02023879|182932952|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.9|||<|0.0001|TWO_SIDED|95.0|-51.8|-38.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.1|-51.8|<0.0001
91699586|NCT02612610|183293932|OTHER||LS Mean Difference|-0.3||||0.3031|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.3031
91699587|NCT02612610|183293933|OTHER||LS Mean Difference|0.0||||0.9126|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.9126
91699588|NCT02612610|183293933|OTHER||LS Mean Difference|-0.5||||0.1136|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.1136
91699589|NCT02612610|183293933|OTHER||LS Mean Difference|-0.7||||0.0352|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.0|-1.4|0.0352
91699590|NCT02612610|183293934|OTHER||LS Mean Difference|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.1|0.1718
91699591|NCT02612610|183293934|OTHER||LS Mean Difference|-0.6||||0.0651|TWO_SIDED|95.0|-1.3|0.0|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.3|0.0651
91730929|NCT02037984|183357021|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.01||||||||1.01|0.46|
91730930|NCT02037984|183357021|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.51|1.22||||||||1.22|0.51|
91730931|NCT02037984|183357021|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.72|||||TWO_SIDED|95.0|0.5|1.05||||||||1.05|0.50|
91730932|NCT02037984|183357021|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.55|||||TWO_SIDED|95.0|0.37|0.8||||||||0.80|0.37|
91492819|NCT01817530|182857475|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492820|NCT01817530|182857475|SUPERIORITY||Odds Ratio (OR)|6.02|||<|0.001|TWO_SIDED|95.0|2.95|12.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||12.3|2.95|< 0.001
91492821|NCT01817530|182857475|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492822|NCT01817530|182857475|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|4.79|22.34||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||22.34|4.79|< 0.001
91492823|NCT01817530|182857475|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492824|NCT01817530|182857476|SUPERIORITY||Odds Ratio (OR)|156.17|||<|0.001|TWO_SIDED|95.0|38.04|641.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||641.22|38.04|< 0.001
91492825|NCT01817530|182857476|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492826|NCT01817530|182857476|SUPERIORITY||Odds Ratio (OR)|66.07|||<|0.001|TWO_SIDED|95.0|21.1|206.88||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||206.88|21.1|< 0.001
91699592|NCT02612610|183293934|OTHER||LS Mean Difference|-0.6||||0.0848|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0848
91730933|NCT02037984|183357021|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.97|||||TWO_SIDED|95.0|0.66|1.44||||||||1.44|0.66|
91730934|NCT02037984|183357021|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.79|||||TWO_SIDED|95.0|0.49|1.28||||||||1.28|0.49|
91730935|NCT02037984|183357021|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|68.64|||||TWO_SIDED|95.0|45.81|102.84||||||||102.84|45.81|
91730936|NCT02037984|183357021|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|20.03|||||TWO_SIDED|95.0|10.88|36.88||||||||36.88|10.88|
91730937|NCT02037984|183357025|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.2|||||TWO_SIDED|95.0|-16.3|6.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.5|-16.3|
91730938|NCT02037984|183357025|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.6|||||TWO_SIDED|95.0|-4.1|32.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.5|-4.1|
91730939|NCT02037984|183357025|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.0|||||TWO_SIDED|95.0|-22.8|5.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.7|-22.8|
91730940|NCT02037984|183357025|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730941|NCT02037984|183357025|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91699593|NCT02612610|183293935|OTHER||LS Mean Difference|-0.1||||0.6715|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6715
91492827|NCT01817530|182857476|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492828|NCT01817530|182857476|SUPERIORITY||Odds Ratio (OR)|52.15|||<|0.001|TWO_SIDED|95.0|17.42|156.09||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||156.09|17.42|< 0.001
91492829|NCT01817530|182857476|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91730942|NCT02037984|183357025|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730943|NCT02037984|183357025|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730944|NCT02037984|183357025|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730945|NCT02037984|183357025|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730946|NCT02037984|183357025|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730947|NCT02037984|183357025|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730948|NCT02037984|183357025|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730949|NCT02037984|183357025|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
91730950|NCT02037984|183357025|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
91730951|NCT02037984|183357025|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.1|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.1|
91730952|NCT02037984|183357026|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-4.2|||||TWO_SIDED|95.0|-20.4|5.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.6|-20.4|
91730953|NCT02037984|183357026|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|11.8|||||TWO_SIDED|95.0|-10.0|30.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||30.6|-10.0|
91730954|NCT02037984|183357026|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-1.6|||||TWO_SIDED|95.0|-18.8|10.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||10.3|-18.8|
91730955|NCT02037984|183357026|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91492830|NCT01817530|182857476|SUPERIORITY||Odds Ratio (OR)|25.45|||<|0.001|TWO_SIDED|95.0|10.45|61.96||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||61.96|10.45|< 0.001
91492831|NCT01817530|182857476|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492832|NCT01817530|182857476|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.001|TWO_SIDED|95.0|4.38|21.25||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.25|4.38|< 0.001
91699594|NCT02612610|183293935|OTHER||LS Mean Difference|-0.3||||0.3514|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3514
91699595|NCT02612610|183293935|OTHER||LS Mean Difference|-0.4||||0.2809|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2809
91492833|NCT01817530|182857476|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492834|NCT01817530|182857476|SUPERIORITY||Odds Ratio (OR)|16.17|||<|0.001|TWO_SIDED|95.0|7.13|36.67||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||36.67|7.13|< 0.001
91699596|NCT02612610|183293936|OTHER||LS Mean Difference|-0.2||||0.6022|TWO_SIDED|95.0|-0.9|0.5|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.9|0.6022
91699597|NCT02612610|183293936|OTHER||LS Mean Difference|-0.3||||0.4456|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4456
91699598|NCT02612610|183293936|OTHER||LS Mean Difference|-0.3||||0.4629|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4629
91699599|NCT02612610|183293937|OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3749
91699600|NCT02612610|183293937|OTHER||LS Mean Difference|-0.6||||0.0854|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0854
91699601|NCT02612610|183293937|OTHER||LS Mean Difference|-0.4||||0.2672|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2672
91699602|NCT02612610|183293938|OTHER||LS Mean Difference|-0.1||||0.7255|TWO_SIDED|95.0|-0.8|0.6|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.8|0.7255
91699603|NCT02612610|183293938|OTHER||LS Mean Difference|-0.6||||0.0918|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0918
91699604|NCT02612610|183293938|OTHER||LS Mean Difference|-0.5||||0.1263|TWO_SIDED|95.0|-1.2|0.2|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.2|0.1263
91699605|NCT02612610|183293939|OTHER||LS Mean Difference|-0.3||||0.4058|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4058
91492835|NCT01817530|182857476|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492836|NCT01817530|182857477|SUPERIORITY||Odds Ratio (OR)|123.14|||<|0.001|TWO_SIDED|95.0|25.93|584.85||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||584.85|25.93|< 0.001
91492837|NCT01817530|182857477|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91699606|NCT02612610|183293939|OTHER||LS Mean Difference|-0.6||||0.0828|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0828
91492838|NCT01817530|182857477|SUPERIORITY||Odds Ratio (OR)|40.56|||<|0.001|TWO_SIDED|95.0|13.59|121.03||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||121.03|13.59|< 0.001
91492839|NCT01817530|182857477|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492840|NCT01817530|182857477|SUPERIORITY||Odds Ratio (OR)|19.01|||<|0.001|TWO_SIDED|95.0|7.44|48.58||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||48.58|7.44|< 0.001
91492841|NCT01817530|182857477|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91699607|NCT02612610|183293939|OTHER||LS Mean Difference|-0.7||||0.0575|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.4|0.0575
91699608|NCT02612610|183293940|OTHER||LS Mean Difference|-0.3||||0.4163|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4163
91699609|NCT02612610|183293940|OTHER||LS Mean Difference|-0.6||||0.0882|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0882
91699610|NCT02612610|183293940|OTHER||LS Mean Difference|-0.6||||0.0961|TWO_SIDED|95.0|-1.4|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.4|0.0961
91699611|NCT02612610|183293941|OTHER||LS Mean Difference|0.8||||0.163|TWO_SIDED|95.0|-0.3|1.9|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-0.3|0.1630
91699612|NCT02612610|183293941|OTHER||LS Mean Difference|0.2||||0.7601|TWO_SIDED|95.0|-1.0|1.3|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.3|-1.0|0.7601
91699613|NCT02612610|183293941|OTHER||LS Mean Difference|2.1||||0.0004|TWO_SIDED|95.0|0.9|3.2|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.2|0.9|0.0004
91699614|NCT02612610|183293942|OTHER||LS Mean Difference|1.0||||0.0941|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0941
91699615|NCT02612610|183293942|OTHER||LS Mean Difference|0.9||||0.1321|TWO_SIDED|95.0|-0.3|2.2|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.2|-0.3|0.1321
91699616|NCT02612610|183293942|OTHER||LS Mean Difference|1.5||||0.0192|TWO_SIDED|95.0|0.2|2.7|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.7|0.2|0.0192
91699617|NCT02612610|183293943|OTHER||LS Mean Difference|1.2||||0.0626|TWO_SIDED|95.0|-0.1|2.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.4|-0.1|0.0626
91699618|NCT02612610|183293943|OTHER||LS Mean Difference|1.0||||0.0967|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0967
91699619|NCT02612610|183293943|OTHER||LS Mean Difference|1.9||||0.0028|TWO_SIDED|95.0|0.7|3.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.1|0.7|0.0028
91730956|NCT02037984|183357026|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
91730957|NCT02037984|183357026|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
91730958|NCT02037984|183357026|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91730959|NCT02037984|183357026|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91730960|NCT02037984|183357026|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91730961|NCT02037984|183357026|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
91730962|NCT02037984|183357026|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91699620|NCT02612610|183293944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3182|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.3182
91730963|NCT02037984|183357026|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91730964|NCT02037984|183357026|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
91730965|NCT02037984|183357026|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|85.0|||||TWO_SIDED|95.0|65.8|93.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||93.6|65.8|
91730966|NCT02037984|183357026|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|92.9|||||TWO_SIDED|95.0|75.1|98.1|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.1|75.1|
91730967|NCT02037984|183357027|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
91730968|NCT02037984|183357027|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|24.3|||||TWO_SIDED|95.0|12.6|40.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||40.2|12.6|
91730969|NCT02037984|183357027|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|2.7|||||TWO_SIDED|95.0|-8.0|14.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||14.0|-8.0|
91730970|NCT02037984|183357027|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730971|NCT02037984|183357027|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730972|NCT02037984|183357027|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
91730973|NCT02037984|183357027|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730974|NCT02037984|183357027|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730975|NCT02037984|183357027|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730976|NCT02037984|183357027|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730977|NCT02037984|183357027|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730978|NCT02037984|183357027|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
91730979|NCT02037984|183357027|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
91730980|NCT02037984|183357027|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
91730981|NCT02037984|183357027|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.7|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.7|
91492842|NCT01817530|182857477|SUPERIORITY||Odds Ratio (OR)|22.77|||<|0.001|TWO_SIDED|95.0|9.29|55.77||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||55.77|9.29|< 0.001
91730982|NCT02037984|183357028|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730983|NCT02037984|183357028|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|18.4|||||TWO_SIDED|95.0|1.7|35.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||35.5|1.7|
91492843|NCT01817530|182857477|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492844|NCT01817530|182857477|SUPERIORITY||Odds Ratio (OR)|10.89|||<|0.001|TWO_SIDED|95.0|4.88|24.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||24.27|4.88|< 0.001
91492845|NCT01817530|182857477|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492846|NCT01817530|182857477|SUPERIORITY||Odds Ratio (OR)|9.72|||<|0.001|TWO_SIDED|95.0|4.46|21.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.22|4.46|< 0.001
91699621|NCT02612610|183293944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5021|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.5021
91699622|NCT02612610|183293944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0665|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0665
91699623|NCT02612610|183293945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0872|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0872
91699624|NCT02612610|183293945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0994|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0994
91699625|NCT02612610|183293945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0009
91699626|NCT02612610|183293946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0037
91699627|NCT02612610|183293946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0166
91699628|NCT02612610|183293946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||<0.0001
91699629|NCT02612610|183293947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0396
91492847|NCT01817530|182857477|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91699630|NCT02612610|183293947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0751|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0751
91699631|NCT02612610|183293947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0010
91730984|NCT02037984|183357028|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-14.9|||||TWO_SIDED|95.0|-31.4|-1.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||-1.2|-31.4|
91730985|NCT02037984|183357028|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730986|NCT02037984|183357028|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91492848|NCT01817530|182857478|SUPERIORITY||Odds Ratio (OR)|24.73|||<|0.001|TWO_SIDED|95.0|8.57|71.32||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||71.32|8.57|< 0.001
91730987|NCT02037984|183357028|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91492849|NCT01817530|182857478|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492850|NCT01817530|182857478|SUPERIORITY||Odds Ratio (OR)|17.21|||<|0.001|TWO_SIDED|95.0|6.57|45.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||45.05|6.57|< 0.001
91492851|NCT01817530|182857478|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492852|NCT01817530|182857478|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.001|TWO_SIDED|95.0|3.79|19.92||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||19.92|3.79|< 0.001
91492853|NCT01817530|182857478|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492854|NCT01817530|182857478|SUPERIORITY||Odds Ratio (OR)|18.67|||<|0.001|TWO_SIDED|95.0|7.11|49.02||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||49.02|7.11|< 0.001
91492855|NCT01817530|182857478|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492856|NCT01817530|182857478|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.43|10.04||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||10.04|2.43|< 0.001
91492857|NCT01817530|182857478|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492858|NCT01817530|182857478|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.001|TWO_SIDED|95.0|5.17|26.79|||Regression, Logistic|P value is from a logistic regression model including treatment as the main effect and baseline value as a covariate.||||26.79|5.17|< 0.001
91492859|NCT01817530|182857478|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492860|NCT01817530|182857479|SUPERIORITY||Odds Ratio (OR)|31.48|||<|0.001|TWO_SIDED|95.0|10.02|98.83||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||98.83|10.02|< 0.001
91492861|NCT01817530|182857479|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492862|NCT01817530|182857479|SUPERIORITY||Odds Ratio (OR)|14.39|||<|0.001|TWO_SIDED|95.0|5.77|35.91||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||35.91|5.77|< 0.001
91492863|NCT01817530|182857479|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492864|NCT01817530|182857479|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.001|TWO_SIDED|95.0|4.23|22.8||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||22.8|4.23|< 0.001
91492865|NCT01817530|182857479|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91730988|NCT02037984|183357028|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730989|NCT02037984|183357028|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730990|NCT02037984|183357028|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91492866|NCT01817530|182857479|SUPERIORITY||Odds Ratio (OR)|16.58|||<|0.001|TWO_SIDED|95.0|6.66|41.26||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||41.26|6.66|< 0.001
91492867|NCT01817530|182857479|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492868|NCT01817530|182857479|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.36|14.68||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||14.68|3.36|< 0.001
91492869|NCT01817530|182857479|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492870|NCT01817530|182857479|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.001|TWO_SIDED|95.0|4.85|23.76||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||23.76|4.85|< 0.001
91528595|NCT02023879|182932953|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.8|-41.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.9|-54.8|<0.0001
91528596|NCT02023879|182932954|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-61.1|<0.0001
91528597|NCT02023879|182932955|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-63.8|-53.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.4|-63.8|<0.0001
91699632|NCT02612610|183293948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test."||||0.8464
91699633|NCT02612610|183293948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7687|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7687
91699634|NCT02612610|183293948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4364|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.4364
91699635|NCT02612610|183293949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9966|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.9966
91492871|NCT01817530|182857479|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
91492872|NCT01817530|182857480|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492873|NCT01817530|182857480|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492874|NCT01817530|182857480|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492875|NCT01817530|182857480|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492876|NCT01817530|182857480|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492877|NCT01817530|182857480|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492878|NCT01817530|182857481|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91528598|NCT02023879|182932956|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.4|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-40.4|-52.4|<0.0001
91492879|NCT01817530|182857481|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492880|NCT01817530|182857481|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492881|NCT01817530|182857481|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492882|NCT01817530|182857481|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492883|NCT01817530|182857481|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91492884|NCT01817530|182857482|SUPERIORITY||difference in LS mean change|-3.7|STANDARD_ERROR_OF_MEAN|1.32||0.007|TWO_SIDED|95.0|-6.28|-1.03||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-1.03|-6.28|0.007
91528599|NCT02023879|182932957|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.6|||<|0.0001|TWO_SIDED|95.0|-54.3|-42.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.8|-54.3|<0.0001
91528600|NCT02023879|182932958|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.9|-43.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-54.9|<0.0001
91699636|NCT02612610|183293949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6372|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6372
91730991|NCT02037984|183357028|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730992|NCT02037984|183357028|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730993|NCT02037984|183357028|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
91730994|NCT02037984|183357028|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-5.9|||||TWO_SIDED|95.0|-19.2|3.9|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.9|-19.2|
91730995|NCT02037984|183357028|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
91730996|NCT02037984|183357028|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.9|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.9|
91492885|NCT01817530|182857482|SUPERIORITY||difference in LS mean change|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.132|TWO_SIDED|95.0|-3.44|0.46||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.46|-3.44|0.132
91492886|NCT01817530|182857482|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.94||0.876|TWO_SIDED|95.0|-1.71|2.0||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||2.00|-1.71|0.876
91492887|NCT01817530|182857482|SUPERIORITY||difference in LS mean change|-1.9|STANDARD_ERROR_OF_MEAN|1.0||0.055|TWO_SIDED|95.0|-3.92|0.04||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.04|-3.92|0.055
91492888|NCT01817530|182857482|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.82||0.898|TWO_SIDED|95.0|-1.52|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|-1.52|0.898
91492889|NCT01817530|182857482|SUPERIORITY||difference in LS mean change|-0.4|STANDARD_ERROR_OF_MEAN|0.81||0.59|TWO_SIDED|95.0|-2.05|1.17||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.17|-2.05|0.59
91492890|NCT01817530|182857483|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.31||0.001|TWO_SIDED|95.0|-1.64|-0.42||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.42|-1.64|0.001
91492891|NCT01817530|182857483|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.42|-0.48||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.48|-1.42|< 0.001
91492892|NCT01817530|182857483|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|95.0|-1.12|-0.25||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.25|-1.12|0.002
91730997|NCT02037984|183357029|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
91730998|NCT02037984|183357029|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.0|||||TWO_SIDED|95.0|-5.5|32.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.0|-5.5|
91730999|NCT02037984|183357029|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.6|||||TWO_SIDED|95.0|-24.2|5.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.2|-24.2|
91731000|NCT02037984|183357029|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
91731001|NCT02037984|183357029|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
91731002|NCT02037984|183357029|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
91731003|NCT02037984|183357029|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
91731004|NCT02037984|183357029|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
91731005|NCT02037984|183357029|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
91731006|NCT02037984|183357029|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
91731007|NCT02037984|183357029|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|-6.9|||||TWO_SIDED|95.0|-22.1|3.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.0|-22.1|
91731008|NCT02037984|183357029|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
91731009|NCT02037984|183357029|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
91731010|NCT02037984|183357029|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
91731011|NCT02037984|183357029|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|93.8|||||TWO_SIDED|95.0|78.5|98.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.3|78.5|
91731012|NCT04350866|183357049|SUPERIORITY||Odds Ratio (OR)|15.61|||<|0.0001|TWO_SIDED|95.0|8.99|21.11|||Regression, Logistic|||pre-training to implementation||21.11|8.99|<0.0001
91731013|NCT04350866|183357049|SUPERIORITY||Odds Ratio (OR)|1.56||||0.18|TWO_SIDED|95.0|0.81|3.0|||Regression, Logistic|||pre-implementation to implementation||3.00|0.81|0.18
91731014|NCT04350866|183357049|SUPERIORITY||Odds Ratio (OR)|1.61||||0.003|TWO_SIDED|95.0|1.17|2.22|||Regression, Logistic|||pre-implementation to implementation||2.22|1.17|0.003
91731015|NCT04350866|183357049|SUPERIORITY||Odds Ratio (OR)|1.16||||0.48|TWO_SIDED|95.0|0.77|1.76|||Regression, Logistic|||pre-implementation to implementation||1.76|0.77|0.48
91731016|NCT04350866|183357052|SUPERIORITY||effect size for mixed effects model|0.72|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
91731017|NCT04350866|183357052|SUPERIORITY||effect size for mixed effects model|0.83|||<|0.0001|||||||Mixed Models Analysis|||Minneapolis VAMC||||<0.0001
91492893|NCT01817530|182857483|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.118|TWO_SIDED|95.0|-1.04|0.12||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.12|-1.04|0.118
91492894|NCT01817530|182857483|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.22|-1.16|0.004
91731018|NCT04350866|183357052|SUPERIORITY||effect size for mixed effects model|0.79|||<|0.0001|||||||Mixed Models Analysis|||Philadelphia VAMC||||<0.0001
91492895|NCT01817530|182857483|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.51|-0.59||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.59|-1.51|< 0.001
91492896|NCT01817530|182857484|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.79|-0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||-0.15|-0.79|0.004
91492897|NCT01817530|182857484|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.314|TWO_SIDED|95.0|-0.4|0.13||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.13|-0.4|0.314
91731019|NCT04350866|183357052|SUPERIORITY||effect size for mixed effects model|0.6|||<|0.0001|||||||Mixed Models Analysis|||Durham VAMC||||<0.0001
91731020|NCT04350866|183357052|SUPERIORITY||effect size for mixed effects model|1.01|||<|0.0001|||||||Mixed Models Analysis|||Baltimore VAMC||||<0.0001
91731021|NCT04350866|183357053|SUPERIORITY||effect size for mixed effects model|1.05|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||All Sites||||<0.0001
91731022|NCT04350866|183357053|SUPERIORITY||effect size for mixed effects model|1.72|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Minneapolis VAMC||||<0.0001
91731023|NCT04350866|183357053|SUPERIORITY||effect size for mixed effects model|0.93|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Philadelphia VAMC||||<0.0001
91731024|NCT04350866|183357053|SUPERIORITY||effect size for mixed effects model|0.82|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Durham VAMC||||<0.0001
91731025|NCT04350866|183357053|SUPERIORITY||effect size for mixed effects model|1.38|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Baltimore VAMC||||<0.0001
91731026|NCT06433908|183357114|OTHER||Ratio of Geometric Least Squares Mean|0.9649|||||TWO_SIDED|90.0|0.8695|1.0707||||||||1.0707|0.8695|
91731027|NCT06433908|183357115|OTHER||Ratio of Geometric Least Squares Mean|1.2941|||||TWO_SIDED|90.0|1.1795|1.4199||||||||1.4199|1.1795|
91731028|NCT06433908|183357116|OTHER||Ratio of Geometric Least Squares Mean|1.2329|||||TWO_SIDED|90.0|1.1171|1.3608||||||||1.3608|1.1171|
91731029|NCT06433908|183357117|OTHER||Ratio of Geometric Least Squares Mean|0.9475|||||TWO_SIDED|90.0|0.7746|1.159||||||||1.1590|0.7746|
91731030|NCT06433908|183357118|OTHER||Ratio of Geometric Least Squares Mean|1.2032|||||TWO_SIDED|90.0|1.162|1.2459||||||||1.2459|1.1620|
91731031|NCT06433908|183357119|OTHER||Ratio of Geometric Least Squares Mean|1.1273|||||TWO_SIDED|90.0|1.0229|1.2423||||||||1.2423|1.0229|
91731032|NCT03768414|183357197|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.72|1.14|||Log Rank|||||1.14|0.72|0.41
91731033|NCT00124306|183357207|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.5|-0.5||||||IC Symptom Index - change from baseline to 12 weeks||-0.5|-2.5|
91731034|NCT00124306|183357207|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.2||||||IC Problem Index - change from baseline to 12 weeks||-0.2|-2.3|
91731035|NCT00124306|183357207|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.3|-1.3||||||Wisconsin Symptom Survey - change from baseline to 12 weeks||-1.3|-6.3|
91731036|NCT04153149|183357218|SUPERIORITY||Hazard Ratio (HR)|0.718|||=|0.0118|TWO_SIDED|95.0|0.555|0.929|||Modified Andersen-Gill Model|||Analysis done using a modified Andersen-Gill model with a robust variance. The model included treatment group, ATTR amyloidosis disease type, New York Heart Association (NYHA) class, age group, and log-transformed baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) as covariates.||0.929|0.555|=0.0118
91731037|NCT04153149|183357219|SUPERIORITY||Hazard Ratio (HR)|0.672|||=|0.0162|TWO_SIDED|95.0|0.487|0.929|||Modified Andersen-Gill Model|||Analysis done using a modified Andersen-Gill model with a robust variance. The model included treatment group, ATTR amyloidosis disease type, NYHA class, age group, and log-transformed baseline NT-proBNP as covariates.||0.929|0.487|=0.0162
91731038|NCT04153149|183357220|SUPERIORITY||Least Square (LS) Mean Difference|26.46|STANDARD_ERROR_OF_MEAN|6.66|=|7.97e-05|TWO_SIDED|95.0|13.38|39.55|||MMRM|||Analysis done using MMRM with baseline 6-MWT as a covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline tafamidis use, treatment-by-baseline tafamidis use interaction, type of ATTR amyloidosis, and age group. Missing change values due to amyloidosis disease progression and death were imputed using sampling with replacement from the worst 10% of observed values, as specified in the SAP.||39.55|13.38|=0.0000797
91731039|NCT04153149|183357221|SUPERIORITY||LS Mean Difference|32.09|STANDARD_ERROR_OF_MEAN|9.19|=|0.0005|TWO_SIDED|95.0|14.03|50.15|||MMRM|||Analysis done using MMRM with baseline 6-MWT as a covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, type of ATTR amyloidosis, and age group. Missing change values due to amyloidosis disease progression and death were imputed using sampling with replacement from the worst 10% of observed values, as specified in the SAP.||50.15|14.03|=0.0005
91731040|NCT04153149|183357222|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|1.73|=|0.0008|TWO_SIDED|95.0|2.4|9.2|||MMRM|||Analysis done using MMRM with baseline KCCQ-OS as a covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline tafamidis use, treatment-by-baseline tafamidis use interaction, type of ATTR amyloidosis, and age group. Missing change values due to death were imputed using sampling with replacement from the worst 10% of observed values, as specified in the SAP.||9.20|2.40|=0.0008
91731041|NCT04153149|183357223|SUPERIORITY||LS Mean Difference|8.69|STANDARD_ERROR_OF_MEAN|2.4|=|0.0003|TWO_SIDED|95.0|3.98|13.4|||MMRM|||Analysis done using MMRM with baseline KCCQ-OS as a covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, type of ATTR amyloidosis, and age group. Missing change values due to death were imputed using sampling with replacement from the worst 10% of observed values, as specified in the SAP.||13.40|3.98|=0.0003
91731042|NCT04153149|183357225|SUPERIORITY||Mean Difference|8.7|||=|0.0217|TWO_SIDED|95.0|1.3|16.1|||Cochran-Mantel-Haenszel|Missing change value in NYHA Class due to death were imputed as worsened. All other missing were imputed using multiple imputation approach.|Adjusted difference in percentage of stable or improved (vutrisiran - placebo) participants was estimated. Adjusted difference, 95% CI, and p-value were derived from multiple imputation procedure by combining estimates per Rubin's rules.|||16.1|1.3|=0.0217
91731043|NCT04153149|183357226|SUPERIORITY||Mean Difference|12.5|||=|0.0121|TWO_SIDED|95.0|2.7|22.2|||Cochran-Mantel-Haenszel|Missing change value in NYHA Class due to death were imputed as worsened. All other missing were imputed using multiple imputation approach.|Adjusted difference in percentage of stable or improved (vutrisiran - placebo) participants was estimated. Adjusted difference, 95% CI, and p-value were derived from multiple imputation procedure by combining estimates per Rubin's rules.|||22.2|2.7|=0.0121
91731044|NCT00266032|183357252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_DEVIATION|29.0|<|0.0001||95.0|-29.0|-20.0|||t-test, 2 sided||Mean of Yaz flexible regimen minus mean of Yaz standard was tested|Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.||-20|-29|<0.0001
91731045|NCT00124657|183357279|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.75|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.48|1.0||||||1-year progression-free survival (n=8)||1.00|0.48|
91731046|NCT00124657|183357279|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.33|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.09|0.57||||||1-year progression-free survival (n=12)||0.57|0.09|
91731047|NCT00124657|183357279|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.45|STANDARD_DEVIATION|0.106|||TWO_SIDED|95.0|0.198|0.602||||||1-year progression free survival (n=20)||0.602|0.198|
91731048|NCT00124657|183357279|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.15|STANDARD_DEVIATION|0.069|||TWO_SIDED|95.0|0.015|0.285||||||2-year progression free survival (n=20)||0.285|0.015|
91731049|NCT00124657|183357279|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||1-year progression free survival (n=21)||0.341|0.039|
91731050|NCT00124657|183357279|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||2-year progression free survival (n=21)||0.341|0.039|
91731051|NCT03533491|183357328|EQUIVALENCE|A test of the null hypothesis that the proportion of participants from pretest to posttest change is equal to zero.|Proportion Difference|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.044|TWO_SIDED||||||t-test, 2 sided||A paired t-test that evaluates whether significant pretest to posttest change in the proportion of users is different from zero.|||||.044
91731052|NCT03533491|183357329|EQUIVALENCE|A test of the null hypothesis that the proportion who use from pretest to posttest is equal to zero.|Proportion Difference|0.035|STANDARD_ERROR_OF_MEAN|0.056||0.532|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether the proportion who use from pretest to posttest change is different from zero.||||||.532
91731053|NCT03533491|183357330|EQUIVALENCE|A test of the null hypothesis that the proportion of participants who use from pretest to posttest is equal to zero.|Proportion Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.058||0.37|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.370
91492898|NCT01817530|182857484|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.307|TWO_SIDED|95.0|-0.12|0.39||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.39|-0.12|0.307
91731054|NCT03533491|183357331|EQUIVALENCE|A test of the null hypothesis that the proportion of participants that use from pretest to posttest is equal to zero.|Proportion Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether proportion who use from pretest to posttest is different from zero.||||||.020
91731055|NCT03533491|183357332|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.108||0.773|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.773
91731056|NCT03533491|183357333|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.978|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.978
91492899|NCT01817530|182857484|SUPERIORITY||difference in LS mean change|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.106|TWO_SIDED|95.0|-0.58|0.06||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.06|-0.58|0.106
91492900|NCT01817530|182857484|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.424|TWO_SIDED|95.0|-0.36|0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.15|-0.36|0.424
91492901|NCT01817530|182857484|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.528|TWO_SIDED|95.0|-0.18|0.35||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.35|-0.18|0.528
91492902|NCT01817530|182857485|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.8|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|0.80|< 0.001
91492903|NCT01817530|182857485|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.78|1.72||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.72|0.78|< 0.001
91492904|NCT01817530|182857485|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.33|1.27||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.27|0.33|< 0.001
91492905|NCT01817530|182857485|SUPERIORITY||difference in LS means|1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.65|1.52||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.52|0.65|< 0.001
91492906|NCT01817530|182857485|SUPERIORITY||difference in LS means|0.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.29|1.16||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.16|0.29|< 0.001
91492907|NCT01817530|182857485|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.4|1.26||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.26|0.4|< 0.001
91492908|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492909|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492910|NCT01817530|182857486|SUPERIORITY|||||||0.018||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.018
91492911|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492912|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492913|NCT01817530|182857486|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.021
91492914|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492915|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492916|NCT01817530|182857486|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.032
91492917|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492918|NCT01817530|182857486|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.007
91731057|NCT03533491|183357334|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.089||0.745|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.745
91731058|NCT03533491|183357335|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.101||0.132|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.132
91731059|NCT03533491|183357336|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.551|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.551
91731060|NCT03533491|183357337|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.255||0.255|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.255
91731061|NCT03533491|183357338|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|||||||A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||
91731062|NCT03533491|183357339|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.091||0.198|TWO_SIDED||||||t-test, 2 sided|||||||.198
91731063|NCT03533491|183357340|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.121||0.77|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.770
91731064|NCT03533491|183357341|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.137||0.834|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.834
91731065|NCT03533491|183357342|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.096|STANDARD_ERROR_OF_MEAN|0.07||0.175|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.175
91731066|NCT02412982|183357380|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
91731067|NCT00803049|183357382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.2079|TWO_SIDED|95.0|0.602|1.128||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.128|0.602|0.2079
91731068|NCT00803049|183357382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.3039|TWO_SIDED|95.0|0.591|1.152||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs.Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.152|0.591|0.3039
91731069|NCT00803049|183357382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8271|TWO_SIDED|95.0|0.736|1.26||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.260|0.736|0.8271
91731070|NCT00803049|183357383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.8017|TWO_SIDED|95.0|0.678|1.362||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.362|0.678|0.8017
91492919|NCT01817530|182857486|SUPERIORITY|||||||0.495||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.495
91731071|NCT00803049|183357383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1866|TWO_SIDED|95.0|0.559|1.117||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.117|0.559|0.1866
91731072|NCT00803049|183357383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8763|TWO_SIDED|95.0|0.767|1.357||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.357|0.767|0.8763
91731073|NCT01272219|183357387|SUPERIORITY_OR_OTHER||Estimated mean difference|-5.39|||<|0.0001|TWO_SIDED|95.0|-5.82|-4.95|||ANCOVA||ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.||-4.95|-5.82|<0.0001
91759159|NCT04038567|183411363|SUPERIORITY||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-0.52|2.15||||||Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.15|-0.52|
91759160|NCT04038567|183411364|SUPERIORITY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.23|0.91||||||||0.91|-1.23|
91759161|NCT04038567|183411364|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.29|-0.15||||||||-0.15|-2.29|
91759162|NCT04038567|183411364|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.77|0.37||||||||0.37|-1.77|
91492920|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492921|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91699637|NCT02612610|183293949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2155|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2155
91699638|NCT02612610|183293950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7559|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7559
91699639|NCT02612610|183293950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5091|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.5091
91699640|NCT02612610|183293950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2790
91492922|NCT01817530|182857486|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.015
91492923|NCT01817530|182857486|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492924|NCT01817530|182857486|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
91492925|NCT01817530|182857486|SUPERIORITY|||||||0.329||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.329
91492926|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492927|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91699641|NCT02612610|183293951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3887|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.3887
91699642|NCT02612610|183293951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2333|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2333
91699643|NCT02612610|183293951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0534|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.0534
91699644|NCT02612610|183293952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6115|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6115
91699645|NCT02612610|183293952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
91699646|NCT02612610|183293952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
91699647|NCT02612610|183293953|SUPERIORITY_OR_OTHER_LEGACY|||||||0||||||"A p-value of zero was calculated if all participants (100%) had No Taste Effect Noted or Not at All responses in both comparison groups."|Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0
91699648|NCT02612610|183293953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
91699649|NCT02612610|183293953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
91731074|NCT01272219|183357388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|4.12|5.6|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.60|4.12|<0.0001
91731075|NCT01272219|183357389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.34|||<|0.0001|TWO_SIDED|95.0|3.54|5.32|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing \>10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.32|3.54|<0.0001
91731076|NCT01272219|183357390|SUPERIORITY_OR_OTHER||Treatment estimate|2.681|||<|0.0001|TWO_SIDED|95.0|1.856|3.872|||Weibull analysis||The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo.|If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM ('diabetes-free time'), is statistically significantly \>1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.||3.872|1.856|<.0001
91731077|NCT00392288|183357477|SUPERIORITY_OR_OTHER|||||||0.2696||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.||||0.2696
91731078|NCT00392288|183357477|SUPERIORITY_OR_OTHER|||||||0.0703||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.||||0.0703
91731079|NCT00392288|183357477|SUPERIORITY_OR_OTHER|||||||0.9146||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.||||0.9146
91731080|NCT02544763|183357480|SUPERIORITY||Percentage reduction|48.6|||||TWO_SIDED|95.0|40.4|55.8||||||||55.8|40.4|
91731081|NCT02544763|183357480|SUPERIORITY||Percentage reduction|47.5|||||TWO_SIDED|95.0|39.0|54.8||||||||54.8|39.0|
91731082|NCT02544763|183357480|SUPERIORITY||Percentage reduction|26.5|||||TWO_SIDED|95.0|14.9|36.5||||||||36.5|14.9|
91731083|NCT02544763|183357480|SUPERIORITY||Treatment ratio|0.699|||=|0.0009|TWO_SIDED|95.0|0.567|0.861|||Mixed Models Analysis|||||0.861|0.567|=0.0009
91731084|NCT02544763|183357480|SUPERIORITY||Treatment ratio|0.715|||=|0.0018|TWO_SIDED|95.0|0.58|0.881|||Mixed Models Analysis|||||0.881|0.580|=0.0018
91492928|NCT01817530|182857487|SUPERIORITY|||||||0.036||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.036
91731085|NCT02544763|183357481|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.0692|TWO_SIDED|95.0|0.95|4.0|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.00|0.95|=0.0692
91492929|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492930|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492931|NCT01817530|182857487|SUPERIORITY|||||||0.04||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||0.040
91731086|NCT02544763|183357481|SUPERIORITY||Odds Ratio (OR)|2.29|||=|0.0245|TWO_SIDED|95.0|1.12|4.67|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.67|1.12|=0.0245
91731087|NCT02544763|183357482|SUPERIORITY||Odds Ratio (OR)|2.25|||=|0.0074|TWO_SIDED|95.0|1.24|4.07|||nominal|The global impression of change was analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||4.07|1.24|=0.0074
91731088|NCT02544763|183357482|SUPERIORITY||Odds Ratio (OR)|1.77|||=|0.058|TWO_SIDED|95.0|0.98|3.2|||nominal|The global impression of change is analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||3.20|0.98|=0.0580
91492932|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492933|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||< 0.001
91492934|NCT01817530|182857487|SUPERIORITY|||||||0.098||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.098
91492935|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91731089|NCT02544763|183357483|SUPERIORITY|Model includes the total number of seizures as a response variable and age group, time (Baseline and treatment period), treatment and treatment by time interaction as fixed effects and participant as a random effect. The log transformed number of days seizures were reported by period is included as an offset.|Percentage reduction|0.519|||||TWO_SIDED|95.0|0.447|0.602||||||||0.602|0.447|
91731090|NCT02544763|183357483|SUPERIORITY||Percentage reduction|0.524|||||TWO_SIDED|95.0|0.452|0.607||||||||0.607|0.452|
91731091|NCT02544763|183357483|SUPERIORITY||Percentage reduction|0.731|||||TWO_SIDED|95.0|0.632|0.846||||||||0.846|0.632|
91492936|NCT01817530|182857487|SUPERIORITY|||||||0.014||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.014
91492937|NCT01817530|182857487|SUPERIORITY|||||||0.409||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.409
91492938|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492939|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492940|NCT01817530|182857487|SUPERIORITY|||||||0.094||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.094
91492941|NCT01817530|182857487|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492942|NCT01817530|182857487|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
91492943|NCT01817530|182857487|SUPERIORITY|||||||0.393||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.393
91492944|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492945|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492946|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492947|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492948|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
91492949|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492950|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492951|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492952|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492953|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492954|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
91492955|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91731092|NCT02544763|183357483|SUPERIORITY||Treatment ratio|0.709|||=|0.0013|TWO_SIDED|95.0|0.576|0.873|||Mixed Models Analysis|||||0.873|0.576|=0.0013
91731093|NCT02544763|183357483|SUPERIORITY||Treatment ratio|0.716|||=|0.0018|TWO_SIDED|95.0|0.582|0.882|||Mixed Models Analysis|||||0.882|0.582|=0.0018
91731094|NCT03109769|183357496|SUPERIORITY|||||||0.0444|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0444
91731095|NCT03109769|183357496|SUPERIORITY||Mean Difference (Net)|-0.1373||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0002
91731096|NCT03109769|183357496|SUPERIORITY||Median Difference (Final Values)|0.0932||||0.0283|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0283
91731097|NCT03109769|183357497|SUPERIORITY|||||||0.0283|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0283
91731098|NCT03109769|183357497|SUPERIORITY||Mean Difference (Net)|-0.1177||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.0002
91492956|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492957|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492958|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492959|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492960|NCT01817530|182857488|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
91492961|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91492962|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91731099|NCT03109769|183357497|SUPERIORITY||Mean Difference (Net)|0.1014||||0.4809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.4809
91492963|NCT01817530|182857489|SUPERIORITY|||||||0.02||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.020
91492964|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91731100|NCT02528305|183357498|SUPERIORITY_OR_OTHER|||||||0.474|||||||ANOVA|||||||0.474
91731101|NCT02528305|183357499|SUPERIORITY_OR_OTHER|||||||0.174|||||||ANOVA|||||||0.174
91731102|NCT02528305|183357500|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
91731103|NCT02528305|183357501|SUPERIORITY|||||||0.023|||||||ANOVA|||||||0.023
91731104|NCT02528305|183357502|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|For the analysis of Total body fat||||||0.092
91731105|NCT02528305|183357502|SUPERIORITY_OR_OTHER|||||||0.101|||||||ANOVA|For the analysis of Trunk fat||||||0.101
91699650|NCT01260272|183293954|SUPERIORITY_OR_OTHER||||||=|0.033||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.033
91699651|NCT01260272|183293955|SUPERIORITY_OR_OTHER||||||=|0.0468||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.0468
91699652|NCT01260272|183293956|SUPERIORITY_OR_OTHER||||||=|0.2114||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2114
91731106|NCT02528305|183357503|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANOVA|For the analysis of systolic blood pressure||||||0.771
91731107|NCT02528305|183357503|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA|For the analysis of diastolic blood pressure||||||0.028
91731108|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.099|||||||ANOVA|For the analysis of Physical Function||||||0.099
91731109|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.566|||||||ANOVA|For the analysis of Social Function||||||0.566
91731110|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.246|||||||ANOVA|For the analysis of Mental Health||||||0.246
91731111|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|For the analysis of Pain||||||0.145
91731112|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|For the analysis of Change in Health||||||0.085
91731113|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANOVA|For the analysis of Physical Role Limitation||||||0.114
91731114|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.841|||||||ANOVA|For the analysis of Mental Role Limitation||||||0.841
91731115|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.366|||||||ANOVA|For the analysis of Energy/Vitality||||||0.366
91492965|NCT01817530|182857489|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.002
91492966|NCT01817530|182857489|SUPERIORITY|||||||0.061||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.061
91699653|NCT01260272|183293957|SUPERIORITY_OR_OTHER||||||=|0.1727||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.1727
91699654|NCT01260272|183293958|SUPERIORITY_OR_OTHER||||||=|0.7498||||||Apriori threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||=0.7498
91699655|NCT01260272|183293959|SUPERIORITY_OR_OTHER||||||=|0.2615||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2615
91699656|NCT01260272|183293960|SUPERIORITY_OR_OTHER||||||=|0.6915||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.6915
91731116|NCT02528305|183357504|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|For the analysis of Health Perception||||||0.745
91731117|NCT02528305|183357505|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANOVA|||||||0.310
91731118|NCT02528305|183357506|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91731119|NCT02528305|183357507|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
91731120|NCT02528305|183357508|SUPERIORITY_OR_OTHER|||||||0.793|||||||ANOVA|||||||0.793
91731121|NCT02528305|183357509|SUPERIORITY_OR_OTHER|||||||0.513|||||||ANOVA|||||||0.513
91731122|NCT02528305|183357510|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANOVA|||||||0.009
91731123|NCT01308788|183357511|SUPERIORITY_OR_OTHER|||||||0.4414||95.0|||||ANCOVA|||||||.4414
91731124|NCT01308788|183357512|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.7820
91731125|NCT01308788|183357513|SUPERIORITY_OR_OTHER|||||||0.5496||95.0|||||ANCOVA|||||||.5496
91731126|NCT01308788|183357514|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANCOVA|||||||.2930
91731127|NCT01308788|183357515|SUPERIORITY_OR_OTHER|||||||0.5058||95.0|||||ANCOVA|||||||.5058
91731128|NCT01308788|183357516|SUPERIORITY_OR_OTHER|||||||0.6156||95.0|||||ANCOVA|||||||.6156
91731129|NCT01308788|183357517|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||||||.5443
91731130|NCT01308788|183357518|SUPERIORITY_OR_OTHER|||||||0.7847||95.0|||||ANCOVA|||||||.7847
91731131|NCT01308788|183357519|SUPERIORITY_OR_OTHER|||||||0.1331||95.0|||||ANCOVA|||||||.1331
91731132|NCT01308788|183357520|SUPERIORITY_OR_OTHER|||||||0.5431||95.0|||||ANCOVA|||||||.5431
91731133|NCT01308788|183357521|SUPERIORITY_OR_OTHER|||||||0.0684||95.0|||||ANCOVA|||||||.0684
91731134|NCT01308788|183357522|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||.2500
91731135|NCT01308788|183357523|SUPERIORITY_OR_OTHER|||||||0.6896||95.0|||||ANCOVA|||||||.6896
91731136|NCT01308788|183357524|SUPERIORITY_OR_OTHER|||||||0.7965||95.0|||||ANCOVA|||||||.7965
91731137|NCT00322218|183357526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8578|||||||Stratified Log-Rank Test|||||||0.8578
91731138|NCT04101331|183357612|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
91731139|NCT04101331|183357613|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
91731140|NCT04101331|183357614|OTHER|||||||0.112||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.112
91731141|NCT04101331|183357616|OTHER|||||||0.537||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.537
91731142|NCT02579759|183357666|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|97.5|-0.68|-0.06|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.06|-0.68|0.008
91731143|NCT02579759|183357666|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.287|TWO_SIDED|97.5|-0.39|0.14|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.14|-0.39|0.287
91731144|NCT02579759|183357666|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.013|TWO_SIDED|97.5|-0.59|-0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||-0.03|-0.59|0.013
91731145|NCT02579759|183357666|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.05|TWO_SIDED|97.5|-0.42|0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||0.03|-0.42|0.05
91731146|NCT02579759|183357666|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.31|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.31|0.013
91731147|NCT02579759|183357667|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.016|TWO_SIDED|97.5|-0.91|-0.03|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.03|-0.91|0.016
91492967|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91492968|NCT01817530|182857489|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.004
91492969|NCT01817530|182857489|SUPERIORITY|||||||0.085||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.085
91492970|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91492971|NCT01817530|182857489|SUPERIORITY|||||||0.012||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.012
91731148|NCT02579759|183357667|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.084|TWO_SIDED|97.5|-0.65|0.08|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.08|-0.65|0.084
91731149|NCT02579759|183357667|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.015|TWO_SIDED|95.0|-0.41|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.41|0.015
91731150|NCT02579759|183357668|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.162|TWO_SIDED|97.5|-1.01|0.23|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-1.01|0.162
91731151|NCT02579759|183357668|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.556|TWO_SIDED|97.5|-0.66|0.39|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.39|-0.66|0.556
91731152|NCT02579759|183357668|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.204|TWO_SIDED|95.0|-0.43|0.09|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.43|0.204
91731153|NCT02579759|183357669|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.36||0.232|TWO_SIDED|97.5|-1.25|0.38|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.38|-1.25|0.232
91731154|NCT02579759|183357669|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.31||0.868|TWO_SIDED|97.5|-0.74|0.64|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.64|-0.74|0.868
91731155|NCT02579759|183357669|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.322|TWO_SIDED|95.0|-0.53|0.17|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.17|-0.53|0.322
91492972|NCT01817530|182857489|SUPERIORITY|||||||0.049||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.049
91731156|NCT02579759|183357670|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.46||0.377|TWO_SIDED|97.5|-1.43|0.62|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.62|-1.43|0.377
91731157|NCT02579759|183357670|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.38||0.334|TWO_SIDED|97.5|-1.21|0.48|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.48|-1.21|0.334
91731158|NCT02579759|183357670|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.373|TWO_SIDED|95.0|-0.62|0.23|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-0.62|0.373
91492973|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91492974|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91699657|NCT01260272|183293961|SUPERIORITY_OR_OTHER|||||||0.106||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||0.1060
91699658|NCT01546571|183293964|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0||||||||||||
91699659|NCT00478699|183293986|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.73|TWO_SIDED|95.0|0.689|1.298|||Log Rank|||Based on the relevant clinical evidence of the prognostic and predictive value of BRCA1, proposes the present study with which it is intended to demonstrate that adjuvant chemotherapy Individualized based on BRCA1 expression (Experimental arm), it is more effective than chemotherapy without individualize based (Control arm) in patients with completely resected stage II-IIIA NSCLC.||1.298|0.689|0.73
91699660|NCT00478699|183293987|SUPERIORITY||Median Difference (Final Values)|79.3||||0.753|TWO_SIDED|95.0|63.5|95.1|||Log Rank|||Control Arm v Experimental Arm||95.1|63.5|0.753
91731159|NCT02579759|183357674|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|97.5|-0.58|0.0|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0|-0.58|0.023
91731160|NCT02579759|183357674|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.162|TWO_SIDED|97.5|-0.4|0.09|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.4|0.162
91492975|NCT01817530|182857489|SUPERIORITY|||||||0.056||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.056
91731161|NCT02579759|183357678|SUPERIORITY||Odds Ratio (OR)|2.09||||0.097|TWO_SIDED|97.5|0.77|5.68|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||5.68|0.77|0.097
91492976|NCT01817530|182857489|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91731162|NCT02579759|183357678|SUPERIORITY||Odds Ratio (OR)|1.07||||0.865|TWO_SIDED|97.5|0.42|2.7|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||2.7|0.42|0.865
91731163|NCT02579759|183357679|SUPERIORITY||Odds Ratio (OR)|3.39||||0.026|TWO_SIDED|97.5|0.99|11.62|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||11.62|0.99|0.026
91492977|NCT01817530|182857489|SUPERIORITY|||||||0.005||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.005
91492978|NCT01817530|182857489|SUPERIORITY|||||||0.088||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.088
91492979|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91731164|NCT02579759|183357679|SUPERIORITY||Odds Ratio (OR)|1.26||||0.569|TWO_SIDED|97.5|0.5|3.16|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||3.16|0.5|0.569
91731165|NCT02943499|183357685|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.||||0.92
91492980|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91492981|NCT01817530|182857490|SUPERIORITY|||||||0.188||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.188
91699661|NCT00478699|183293987|SUPERIORITY|The initial hyphotesis were the disease free survival were longest under 65 vs upper 65.|Median Difference (Final Values)|38.7||||0.025|TWO_SIDED|95.0|28.0|38.7|||Log Rank|||Control Arm v Experimental Arm||38.7|28|0.025
91699662|NCT01508130|183293988|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.6451|TWO_SIDED|95.0|0.78|1.49|||Wald residual chi-square test||Due to the non-interventional study design, the Cox model included a propensity score as a covariate (incorporated important demographics and baseline characteristics) to account for the potential imbalance between treatment groups.|||1.49|0.78|0.6451
91699663|NCT01508130|183293988|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.8826|TWO_SIDED|95.0|0.78|1.34|||Wald residual chi-square test||Without Propensity Score as a Covariate.|||1.34|0.78|0.8826
91699664|NCT01508130|183293989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7695|TWO_SIDED|95.0|0.58|1.49|||Multiple Logistic Regression||A multiple logistic regression model including a propensity score as a covariate (incorporated important demographics and baseline characteristics) was used for the treatment comparison.|||1.49|0.58|0.7695
91731166|NCT00666263|183357708|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|35.13||||0.005|TWO_SIDED|95.0|8.81|61.46|||ANOVA|Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), \& treatment (IGIV, 10% or placebo)||||61.46|8.81|0.005
91731167|NCT00666263|183357709|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
91731168|NCT00666263|183357711|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|32.54|||<|0.001|TWO_SIDED|95.0|14.01|51.06|||ANOVA|||||51.06|14.01|<0.001
91731169|NCT00666263|183357712|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
91731170|NCT00666263|183357716|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|6.03||||0.002|TWO_SIDED|95.0|2.14|9.92|||ANOVA|||||9.92|2.14|0.002
91731171|NCT00666263|183357718|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-15.57|||<|0.001|TWO_SIDED|95.0|-24.37|-6.77|||ANOVA|||||-6.77|-24.37|<0.001
91492982|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91492983|NCT01817530|182857490|SUPERIORITY|||||||0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.001
91492984|NCT01817530|182857490|SUPERIORITY|||||||0.104||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.104
91731172|NCT00666263|183357720|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-26.11|||<|0.001|TWO_SIDED|95.0|-38.96|-13.26|||ANOVA|||||-13.26|-38.96|<0.001
91492985|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91492986|NCT01817530|182857490|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.021
91492987|NCT01817530|182857490|SUPERIORITY|||||||0.859||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.859
91492988|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91492989|NCT01817530|182857490|SUPERIORITY|||||||0.006||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.006
91492990|NCT01817530|182857490|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.015
91731173|NCT00666263|183357722|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-216.6||||0.059|TWO_SIDED|95.0|-490.41|57.22|||ANOVA|||||57.22|-490.41|0.059
91731174|NCT00666263|183357724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
91731175|NCT00666263|183357725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0|||||McNemar|||||||0.021
91731176|NCT00586157|183357736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Z-test|||||||<.001
91731177|NCT00586157|183357737|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Z-test|||||||.001
91731178|NCT00586157|183357738|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Z-test|||||||.003
91731179|NCT02853136|183357756|OTHER||Adjusted geometric Mean ratio [%]|3107.8|||||TWO_SIDED|90.0|2332.9|4140.1|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\] =42.7.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4140.10|2332.90|
91731180|NCT02853136|183357757|OTHER||Adjusted geometric Mean ratio [%]|659.0|||||TWO_SIDED|90.0|489.791|886.676|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\]=44.8.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||886.676|489.791|
91731181|NCT02853136|183357758|OTHER||Adjusted geometric Mean ratio [%]|3103.41|||||TWO_SIDED|90.0|2330.5|4132.65|||||"The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2.~Intra-individual geometric coefficient of variation \[%\] =42.7."|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4132.65|2330.50|
91492991|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91492992|NCT01817530|182857490|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.007
91492993|NCT01817530|182857490|SUPERIORITY|||||||0.722||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.722
91492994|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91492995|NCT01817530|182857490|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91492996|NCT01817530|182857490|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.032
91492997|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91492998|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91492999|NCT01817530|182857491|SUPERIORITY|||||||0.041||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.041
91493000|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91493001|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
91493002|NCT01817530|182857491|SUPERIORITY|||||||0.008||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.008
91493003|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91493004|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91493005|NCT01817530|182857491|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
91493006|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91493007|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
91493008|NCT01817530|182857491|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
91493009|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91493010|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91493011|NCT01817530|182857491|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.004
91493012|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91493013|NCT01817530|182857491|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
91699665|NCT01508130|183293989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.2594|TWO_SIDED|95.0|0.84|1.92|||Multiple Logistic Regression||Without Propensity Score as a Covariate|||1.92|0.84|0.2594
91699666|NCT01508130|183293996|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.9156|TWO_SIDED|95.0|0.64|1.64|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.64|0.64|0.9156
91699667|NCT01508130|183293997|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.5649|TWO_SIDED|95.0|0.57|1.36|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.36|0.57|0.5649
91699668|NCT03403751|183294053|SUPERIORITY|||||||0.649|||||||Chi-squared|||||||0.649
91731182|NCT00841815|183357759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|96.43||||||90.0|91.4|101.74|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.74|91.40|
91731183|NCT00841815|183357760|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.94||||||90.0|95.6|106.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.58|95.60|
91731184|NCT00841815|183357761|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.11||||||90.0|95.08|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.40|95.08|
91731185|NCT02732145|183357782|OTHER|"Question: Determination of sensitivity of the Vulvoscopy Index as a measure of the sensitivity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
91731186|NCT02732145|183357782|OTHER|"Question: Determination of specificity of the Vulvoscopy index as a measure of the specificity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)"|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
91493014|NCT01817530|182857491|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.002
91493015|NCT01817530|182857492|SUPERIORITY||difference in LS means|-1.5|STANDARD_ERROR_OF_MEAN|2.58||0.556|TWO_SIDED|95.0|-6.65|3.59||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||3.59|-6.65|0.556
91493016|NCT01817530|182857492|SUPERIORITY||difference in LS means|-1.1|STANDARD_ERROR_OF_MEAN|2.63||0.672|TWO_SIDED|95.0|-6.33|4.09||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||4.09|-6.33|0.672
91493017|NCT01817530|182857492|SUPERIORITY||difference in LS means|3.0|STANDARD_ERROR_OF_MEAN|2.71||0.274|TWO_SIDED|95.0|-2.39|8.36||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||8.36|-2.39|0.274
91493018|NCT01817530|182857492|SUPERIORITY||difference in LS means|-2.0|STANDARD_ERROR_OF_MEAN|1.65||0.223|TWO_SIDED|95.0|-5.26|1.23||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.23|-5.26|0.223
91493019|NCT01817530|182857492|SUPERIORITY||difference in LS means|-2.1|STANDARD_ERROR_OF_MEAN|1.68||0.215|TWO_SIDED|95.0|-5.38|1.22||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.22|-5.38|0.215
91493020|NCT01817530|182857492|SUPERIORITY||difference in LS means|-1.4|STANDARD_ERROR_OF_MEAN|1.68||0.392|TWO_SIDED|95.0|-4.75|1.87||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.87|-4.75|0.392
91493021|NCT02761252|182857580|SUPERIORITY||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.3429||0.5721|TWO_SIDED|95.0|-0.8693|0.4813|||ANCOVA|||||0.4813|-0.8693|0.5721
91493022|NCT02761252|182857581|SUPERIORITY||Mean Difference (Final Values)|-1.1552|STANDARD_ERROR_OF_MEAN|0.4489||0.0105|TWO_SIDED|95.0|-2.0379|-0.2725|||ANCOVA|||||-0.2725|-2.0379|0.0105
91493023|NCT02761252|182857582|SUPERIORITY||Mean Difference (Final Values)|-0.1393|STANDARD_ERROR_OF_MEAN|0.2009||0.4885|TWO_SIDED|95.0|-0.5342|0.2557|||ANCOVA|||||0.2557|-0.5342|0.4885
91493024|NCT02761252|182857583|SUPERIORITY||Mean Difference (Final Values)|-0.03615|STANDARD_ERROR_OF_MEAN|0.1504||0.81032|TWO_SIDED|95.0|-0.3319|0.2596|||ANCOVA|||||0.2596|-0.3319|0.81032
91493025|NCT02761252|182857584|OTHER||Mean Difference (Final Values)|0.8359|STANDARD_ERROR_OF_MEAN|0.9322||0.3704|TWO_SIDED|95.0|-0.9969|2.6688|||ANOVA|||||2.6688|-0.9969|0.3704
91493026|NCT02761252|182857585|SUPERIORITY||Median Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|2.5735||0.7452|TWO_SIDED|95.0|-5.8968|4.2228|||ANOVA|||||4.2228|-5.8968|0.7452
91493027|NCT01758432|182857590|SUPERIORITY||Least Squares Means (Difference)|-95.74|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493028|NCT01758432|182857590|SUPERIORITY||Least Squares Means (Difference)|-130.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493029|NCT01758432|182857590|SUPERIORITY||Least Squares Means (Difference)|-129.86|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493030|NCT01758432|182857590|SUPERIORITY||Least Squares Means (Difference)|-165.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493031|NCT01758432|182857590|SUPERIORITY||Least Squares Means (Difference)|-167.94|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493032|NCT01758432|182857590|SUPERIORITY||Least Squares Means (Difference)|-135.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493033|NCT01758432|182857591|SUPERIORITY||Least Squares Means (Difference)|85559.49||||0.0004|TWO_SIDED|95.0|||||ANCOVA|||||||0.0004
91493034|NCT01758432|182857591|SUPERIORITY||Least Squares Means (Difference)|105508.3|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493035|NCT01758432|182857591|SUPERIORITY||Least Squares Means (Difference)|182753.2|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493036|NCT01758432|182857591|SUPERIORITY||Least Squares Means (Difference)|193684.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493037|NCT01758432|182857591|SUPERIORITY||Least Squares Means (Difference)|178055.0|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493038|NCT01758432|182857591|SUPERIORITY||Least Squares Means (Difference)|169709.9|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493039|NCT01758432|182857592|SUPERIORITY||Least Squares Means (Difference)|-4.58|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493040|NCT01758432|182857592|SUPERIORITY||Least Squares Means (Difference)|-4.29|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493041|NCT01758432|182857592|SUPERIORITY||Least Squares Means (Difference)|-6.15|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493042|NCT01758432|182857592|SUPERIORITY||Least Squares Means (Difference)|-6.79|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493043|NCT01758432|182857592|SUPERIORITY||Least Squares Means (Difference)|-7.49|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493044|NCT01758432|182857592|SUPERIORITY||Least Squares Means (Difference)|-6.71|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
91493045|NCT04115839|182857624|SUPERIORITY||Difference in response rates|26.9||||0.022|TWO_SIDED|95.0|4.3|49.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio)DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.6|4.3|0.022
91699669|NCT03403751|183294056|SUPERIORITY|||||||0.871|||||||Chi-squared|||||||0.871
91699670|NCT03403751|183294057|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
91699671|NCT03403751|183294058|SUPERIORITY|||||||0.448|||||||Wilcoxon (Mann-Whitney)|||||||0.448
91699672|NCT03403751|183294059|SUPERIORITY|||||||0.579|||||||Wilcoxon (Mann-Whitney)|||||||0.579
91699673|NCT03403751|183294060|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
91699674|NCT03403751|183294063|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91699675|NCT03403751|183294064|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91699676|NCT03403751|183294065|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91699677|NCT03403751|183294066|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91699678|NCT01623037|183294069|OTHER||sucess proportion|71.1|||||TWO_SIDED|95.0|55.7|83.6||||||||83.6|55.7|
91699679|NCT04442269|183294094|SUPERIORITY||Mean Difference|0.201||||0.0022|TWO_SIDED|95.0|0.0768|0.3256|||Mixed Models Analysis|||||0.3256|0.0768|0.0022
91699680|NCT03559868|183294112|SUPERIORITY||||||<|0.01|||||||ANOVA|Ordinary one-way ANOVA Bartlett's test||For IL10||||<0.01
91699681|NCT01817582|183294199|OTHER||Least square (LS) mean difference|0.3||||0.6199|TWO_SIDED|95.0|-0.7|1.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.3|-0.7|0.6199
91699682|NCT01817582|183294199|OTHER||LS mean difference|0.1||||0.807|TWO_SIDED|95.0|-0.9|1.2||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.2|-0.9|0.8070
91699683|NCT01817582|183294199|OTHER||LS mean difference|-0.1||||0.8068|TWO_SIDED|95.0|-1.1|0.9||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||0.9|-1.1|0.8068
91699684|NCT01817582|183294200|OTHER||LS mean difference|-4.4||||0.2296|TWO_SIDED|95.0|-11.6|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.8|-11.6|0.2296
91699685|NCT01817582|183294200|OTHER||LS mean difference|-4.9||||0.189|TWO_SIDED|95.0|-12.3|2.5||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.5|-12.3|0.1890
91699686|NCT01817582|183294200|OTHER||LS mean difference|-0.5||||0.8836|TWO_SIDED|95.0|-7.7|6.7||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||6.7|-7.7|0.8836
91699687|NCT03053063|183294218|SUPERIORITY||Percentage Difference|1.9||||0.5572|TWO_SIDED|95.0|-4.4|8.2||Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-4.4|0.5572
91699688|NCT03053063|183294218|SUPERIORITY||Percentage Difference|0.3||||0.9272|TWO_SIDED|95.0|-6.0|6.5||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||6.5|-6.0|0.9272
91699689|NCT03053063|183294221|SUPERIORITY||Percentage Difference|3.8||||0.285|TWO_SIDED|95.0|-3.1|10.6||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||10.6|-3.1|0.2850
91699690|NCT03053063|183294221|SUPERIORITY||Percentage Difference|1.5||||0.6731|TWO_SIDED|95.0|-5.3|8.2||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-5.3|0.6731
91699691|NCT03053063|183294223|SUPERIORITY||Percentage Difference|-1.7||||0.365|TWO_SIDED|95.0|-5.5|2.0||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||2.0|-5.5|0.3650
91699692|NCT03053063|183294223|SUPERIORITY||Percentage Difference|-0.4||||0.8557|TWO_SIDED|95.0|-4.3|3.6||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||3.6|-4.3|0.8557
91699693|NCT00197002|183294241|NON_INFERIORITY_OR_EQUIVALENCE|"The two-sided standardized asymptotic 95% confidence interval (CI) for the difference in seropositivity rates \[Havrix+Prevnar Group minus Havrix Group\] was computed. The anti-HAV seropositivity rates in the Havrix+Prevnar Group were considered as non-inferior to the seropositivity rates in the Havrix Group, if the lower limit of the 95% CI was not lower (≥) than -5%.~The non-inferiority was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Difference in seropositivity rate|-1.06|||||TWO_SIDED|95.0|-5.78|2.45||||||"Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10)."||2.45|-5.78|
91699694|NCT00197002|183294242|NON_INFERIORITY_OR_EQUIVALENCE|"The standardized two-sided 95% CI for the GMC ratio (Havrix+Prevnar Group divided by Havrix Group) was computed. The anti-HAV GMC in the Havrix+Prevnar Group was considered as non-inferior to the anti-HAV GMC in the Havrix Group if the lower limit of the 95% CI was not lower than (≥) 0.5.~The non-inferiority of the anti-HAV immune response in Havrix+Prevnar Group compared to Havrix Group was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.63|1.31|||ANCOVA|||To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).||1.31|0.63|
91493046|NCT04115839|182857624|SUPERIORITY||Difference in response rates|2.2||||0.89|TWO_SIDED|95.0|-20.5|25.0||The stratification factors (Geographic Region, Concurrent Use of csDMARD(s) and/or Apremilast at Randomization, Prior Use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||25.0|-20.5|0.89
91493047|NCT04115839|182857627|SUPERIORITY||Difference in response rates|-5.9||||0.39|TWO_SIDED|95.0|-21.6|9.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||9.9|-21.6|0.39
91493048|NCT04115839|182857627|SUPERIORITY||Difference in response rates|-2.6||||0.65|TWO_SIDED|95.0|-19.7|14.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||14.5|-19.7|0.65
91699695|NCT03569293|183294262|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|63.4|||<|0.001|TWO_SIDED|95.0|57.1|69.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||69.8|57.1|<0.001
91699696|NCT03569293|183294262|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.4|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.2|46.4|<0.001
91699697|NCT03569293|183294263|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|47.2|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||60.0|47.2|<0.001
91699698|NCT03569293|183294263|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|39.8|||<|0.001|TWO_SIDED|95.0|33.2|46.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||46.4|33.2|<0.001
91699699|NCT03569293|183294264|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.2|||<|0.001|TWO_SIDED|95.0|41.3|55.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.0|41.3|<0.001
91699700|NCT03569293|183294264|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.5|||<|0.001|TWO_SIDED|95.0|33.5|47.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||47.5|33.5|<0.001
91699701|NCT03569293|183294265|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.8|||<|0.001|TWO_SIDED|95.0|51.5|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||64.1|51.5|<0.001
91699702|NCT03569293|183294265|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|38.6|51.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.7|38.6|<0.001
91699703|NCT03569293|183294266|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|62.3|||<|0.001|TWO_SIDED|95.0|56.3|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||68.3|56.3|<0.001
91493049|NCT04115839|182857627|SUPERIORITY||Difference in response rates|0.9||||0.86|TWO_SIDED|-19.4|-19.4|21.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||21.3|-19.4|0.86
91493050|NCT04115839|182857627|SUPERIORITY||Difference in response rates|-2.9||||0.7|TWO_SIDED|95.0|-22.0|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.1|-22.0|0.70
91493051|NCT04115839|182857627|SUPERIORITY||Difference in response rates|12.4||||0.15|TWO_SIDED|95.0|-7.5|32.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||32.3|-7.5|0.15
91493052|NCT04115839|182857627|SUPERIORITY||Difference in response rates|8.8||||0.3|TWO_SIDED|95.0|-10.1|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||27.7|-10.1|0.30
91493053|NCT04115839|182857627|SUPERIORITY||Difference in response rates|22.3||||0.035|TWO_SIDED|95.0|-0.7|45.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.2|-0.7|0.035
91493054|NCT04115839|182857627|SUPERIORITY||Difference in response rates|12.1||||0.22|TWO_SIDED|95.0|-9.3|33.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.5|-9.3|0.22
91493055|NCT04115839|182857629|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.8|2.8|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.8|-2.8|
91493056|NCT04115839|182857629|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
91493057|NCT04115839|182857629|SUPERIORITY||Difference in response rates|3.1|||||TWO_SIDED|95.0|-5.9|12.2|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||12.2|-5.9|
91493058|NCT04115839|182857629|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||2.9|-2.9|
91493059|NCT04115839|182857629|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-5.8|11.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||11.9|-5.8|
91699704|NCT03569293|183294266|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|40.7|53.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.4|40.7|<0.001
91699705|NCT03569293|183294267|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|37.7|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.0|37.7|<0.001
91493060|NCT04115839|182857629|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-5.0|16.7|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||16.7|-5.0|
91493061|NCT04115839|182857629|SUPERIORITY||Difference in response rates|0.1|||||TWO_SIDED|95.0|-11.4|11.6|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||11.6|-11.4|
91493062|NCT04115839|182857629|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-10.0|16.1|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||16.1|-10.0|
91493063|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.24|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from mixed-effects model for repeated measures (MMRM) having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.24
91493064|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.22|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.22
91528601|NCT02023879|182932959|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.7|||<|0.0001|TWO_SIDED|95.0|-57.1|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.4|-57.1|<0.0001
91699706|NCT03569293|183294267|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|28.6|40.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.5|28.6|<0.001
91699707|NCT03569293|183294268|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|19.2|||<|0.001|TWO_SIDED|95.0|14.6|23.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||23.9|14.6|<0.001
91731187|NCT02732145|183357782|OTHER|"Question: Determination of diagnostic accuracy of the Vulvoscopy index as a measure of the diagnostic value of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)"|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
91731188|NCT02732145|183357782|SUPERIORITY|"Question: Determination of positive predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
91731189|NCT02732145|183357782|OTHER|"Question: Determination of negative predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
91731190|NCT02732145|183357782|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the Vulvoscopy Index as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the Vulvoscopy Index and histopathology for detection of vulvar dermatosis."||||0.6108
91493065|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.43
91493066|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.7|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.70
91731191|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731192|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9628|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9628
91493067|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.1|TWO_SIDED|95.0|-2.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0|-2|0.10
91493068|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||1|-1|0.90
91493069|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.88|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.88
91493070|NCT04115839|182857637|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.89|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.89
91699708|NCT03569293|183294268|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.6|||<|0.001|TWO_SIDED|95.0|10.3|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||18.8|10.3|<0.001
91699709|NCT03569293|183294269|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.1|||<|0.001|TWO_SIDED|95.0|3.8|12.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.5|3.8|<0.001
91731193|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9152|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9152
91731194|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731195|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with vulvar dermatosis diagnosed with vulvoscopy and histopathology?||||||0.8862|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8862
91731196|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731197|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3319|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3319
91731198|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8662|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8662
91731199|NCT02732145|183357783|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731200|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5399|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5399
91731201|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
91731202|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
91731203|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7537|||||||t|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7537
91731204|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2054|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2054
91731205|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6409|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6409
91731206|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
91731207|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8986|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8986
91731208|NCT02732145|183357784|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0017|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0017
91731209|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731210|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (mean) among patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9899|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9899
91731211|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9686|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9686
91528602|NCT02023879|182932960|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.8|-30.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.8|-39.8|<0.0001
91699710|NCT03569293|183294270|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.0|||<|0.001|TWO_SIDED|95.0|8.1|17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.8|8.1|<0.001
91699711|NCT03569293|183294271|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-25.2|||<|0.001|TWO_SIDED|95.0|-30.3|-20.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-20.1|-30.3|<0.001
91731212|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7055|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7055
91731213|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8852|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8852
91731214|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731215|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3351|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3351
91493071|NCT04115839|182857641|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-15.9|16.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||16.5|-15.9|
91493072|NCT04115839|182857641|SUPERIORITY||Difference in response rates|12.6|||||TWO_SIDED|95.0|-7.1|32.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.3|-7.1|
91493073|NCT04115839|182857641|SUPERIORITY||Difference in response rates|26.6|||||TWO_SIDED|95.0|3.0|50.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||50.2|3.0|
91699712|NCT03569293|183294271|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.3|-18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-18.9|-29.3|<0.001
91699713|NCT03569293|183294272|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.2|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|45.2|<0.001
91699714|NCT03569293|183294272|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|41.8|||<|0.001|TWO_SIDED|95.0|33.9|49.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||49.7|33.9|<0.001
91699715|NCT03569293|183294273|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.6|||<|0.001|TWO_SIDED|95.0|41.0|56.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.1|41.0|<0.001
91699716|NCT03569293|183294273|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|30.9|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|30.9|<0.001
91699717|NCT03569293|183294274|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.4|60.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.3|45.4|<0.001
91699718|NCT03569293|183294274|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.3|||<|0.001|TWO_SIDED|95.0|30.4|46.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.2|30.4|<0.001
91699719|NCT03569293|183294275|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|44.7|60.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.4|44.7|<0.001
91731216|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
91493074|NCT04115839|182857641|SUPERIORITY||Difference in response rates|18.2|||||TWO_SIDED|95.0|-4.1|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.4|-4.1|
91493075|NCT04115839|182857643|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.5|-5.6|
91699720|NCT03569293|183294275|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|42.7|||<|0.001|TWO_SIDED|95.0|34.4|50.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.9|34.4|<0.001
91699721|NCT03569293|183294276|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|44.9|61.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.3|44.9|<0.001
91699722|NCT03569293|183294276|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|36.2|53.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.2|36.2|<0.001
91699723|NCT03569293|183294277|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|20.0|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||30.6|20.0|<0.001
91699724|NCT03569293|183294277|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|15.0|||<|0.001|TWO_SIDED|95.0|10.4|19.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.6|10.4|<0.001
91699725|NCT03569293|183294278|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-45.98|STANDARD_ERROR_OF_MEAN|6.549|<|0.001|TWO_SIDED|95.0|-58.82|-33.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.15|-58.82|<0.001
91699726|NCT03569293|183294278|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-36.74|||<|0.001|TWO_SIDED|95.0|-49.66|-23.81|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-23.81|-49.66|<0.001
91699727|NCT03569293|183294279|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-47.03|STANDARD_ERROR_OF_MEAN|2.716|<|0.001|TWO_SIDED|95.0|-52.37|-41.7|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-41.70|-52.37|<0.001
91699728|NCT03569293|183294279|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.738|<|0.001|TWO_SIDED|95.0|-44.91|-34.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.15|-44.91|<0.001
91731217|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
91528603|NCT02023879|182932961|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-44.3|-32.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.1|-44.3|<0.0001
91699729|NCT03569293|183294280|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|58.6|||<|0.001|TWO_SIDED|95.0|51.9|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||65.3|51.9|<0.001
91731218|NCT02732145|183357785|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (mean) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731219|NCT02732145|183357785|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8472|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8472
91731220|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731221|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9629|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9629
91731222|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9155|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9155
91731223|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.4913|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.4913
91731224|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8866|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8866
91731225|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731226|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3335|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3335
91493076|NCT04115839|182857643|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
91731227|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
91731228|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
91731229|NCT02732145|183357787|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (median) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
91731230|NCT02732145|183357787|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8144|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8144
91731231|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5403|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5403
91731232|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
91731233|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
91731234|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5124|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5124
91731235|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2058|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2058
91731236|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6412|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6412
91731237|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
91731238|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3621|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3621
91731239|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8987|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8987
91731240|NCT02732145|183357788|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar lesions specific for dermatosis (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0018
91493077|NCT04115839|182857643|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-2.0|27.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.8|-2.0|
91731241|NCT02732145|183357788|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.4409|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.4409
91731242|NCT02732145|183357789|OTHER|"Question: Determination of sensitivity of the N-S-P Scheme as a measure of the sensitivity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
91759163|NCT04038567|183411365|SUPERIORITY||Mean Difference (Final Values)|-1.58|||||TWO_SIDED|95.0|-4.41|1.25||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.25|-4.41|
91731243|NCT02732145|183357789|OTHER|"Question: Determination of specificity of the N-S-P Scheme as a measure of the specificity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)."|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
91731244|NCT02732145|183357789|OTHER|"Question: Determination of diagnostic accuracy of the N-S-P Scheme as a measure of the diagnostic value of the Three Rings Vulvoscopy, in relation to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)."|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
91731245|NCT02732145|183357789|OTHER|"Question: Determination of positive predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
91731246|NCT02732145|183357789|OTHER|"Question: Determination of negative predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
91731247|NCT02732145|183357789|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the N-S-P Scheme as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the N-S-P Scheme and histopathology for detection of vulvar dermatosis."||||0.6108
91731248|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9286|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9286
91731249|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8618|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8618
91731250|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9786|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9786
91731251|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
91731252|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8634|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8634
91731253|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7992|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7992
91731254|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.3912|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.3912
91731255|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6152|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6152
91731256|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6108
91731257|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
91731258|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7912|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7912
91493078|NCT04115839|182857643|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
91699730|NCT03569293|183294280|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|52.3|||<|0.001|TWO_SIDED|95.0|45.2|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|45.2|<0.001
91699731|NCT03569293|183294281|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|45.9|60.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.5|45.9|<0.001
91699732|NCT03569293|183294281|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|39.0|54.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.4|39.0|<0.001
91699733|NCT03569293|183294282|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.39|STANDARD_ERROR_OF_MEAN|2.732|<|0.001|TWO_SIDED|95.0|-45.75|-35.03|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-35.03|-45.75|<0.001
91699734|NCT03569293|183294282|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-33.03|STANDARD_ERROR_OF_MEAN|2.758|<|0.001|TWO_SIDED|95.0|-38.44|-27.61|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.61|-38.44|<0.001
91699735|NCT03569293|183294283|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|24.8|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.1|24.8|<0.001
91699736|NCT03569293|183294283|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|21.4|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||41.6|21.4|<0.001
91699737|NCT03569293|183294284|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|30.8|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|30.8|<0.001
91699738|NCT03569293|183294284|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|25.9|||<|0.001|TWO_SIDED|95.0|19.7|32.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||32.1|19.7|<0.001
91699739|NCT03569293|183294285|SUPERIORITY||Adjusted Response Rate Difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||79.4|53.8|<0.001
91699740|NCT03569293|183294285|SUPERIORITY||Adjusted Response Rate Difference|62.0|||<|0.001|TWO_SIDED|95.0|48.6|75.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.4|48.6|<0.001
91699741|NCT03569293|183294286|SUPERIORITY||Adjusted Response Rate Difference|57.4|||<|0.001|TWO_SIDED|95.0|44.6|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|44.6|<0.001
91699742|NCT03569293|183294286|SUPERIORITY||Adjusted Response Rate Difference|39.1|||<|0.001|TWO_SIDED|95.0|25.6|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|25.6|<0.001
91699743|NCT03569293|183294287|SUPERIORITY||Adjusted Response Rate Difference|46.6|||<|0.001|TWO_SIDED|95.0|32.6|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.6|32.6|<0.001
91699744|NCT03569293|183294287|SUPERIORITY||Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|24.3|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|24.3|<0.001
91699745|NCT03569293|183294288|SUPERIORITY||Adjusted Response Rate Difference|63.9|||<|0.001|TWO_SIDED|95.0|51.8|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.9|51.8|<0.001
91699746|NCT03569293|183294288|SUPERIORITY||Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|30.9|56.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.7|30.9|<0.001
91699747|NCT03569293|183294289|SUPERIORITY||Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|41.7|67.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.8|41.7|<0.001
91699748|NCT03569293|183294289|SUPERIORITY||Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|32.0|58.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||58.3|32.0|<0.001
91699749|NCT03569293|183294290|SUPERIORITY||Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|34.0|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.2|34.0|<0.001
91699750|NCT03569293|183294290|SUPERIORITY||Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|23.2|48.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.6|23.2|<0.001
91699751|NCT03569293|183294291|SUPERIORITY||Adjusted Response Rate Difference|21.0|||<|0.001|TWO_SIDED|95.0|11.0|31.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.1|11.0|<0.001
91699752|NCT03569293|183294291|SUPERIORITY||Adjusted Response Rate Difference|9.4||||0.008|TWO_SIDED|95.0|2.5|16.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||16.4|2.5|0.008
91699753|NCT03569293|183294292|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.015|TWO_SIDED|95.0|2.1|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||19.9|2.1|0.015
91699754|NCT03569293|183294292|SUPERIORITY||Adjusted Response Rate Difference|6.5||||0.086|TWO_SIDED|95.0|-0.9|13.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||13.9|-0.9|0.086
91699755|NCT03569293|183294293|SUPERIORITY||Adjusted Response Rate Difference|10.8||||0.045|TWO_SIDED|95.0|0.2|21.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.4|0.2|0.045
91699756|NCT03569293|183294293|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.04|TWO_SIDED|95.0|0.5|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|0.5|0.040
91699757|NCT03569293|183294294|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.6|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.6|<0.001
91699758|NCT03569293|183294294|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.7|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.7|<0.001
91699759|NCT03569293|183294295|SUPERIORITY||Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.7|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|37.7|<0.001
91699760|NCT03569293|183294295|SUPERIORITY||Adjusted Response Rate Difference|34.8|||<|0.001|TWO_SIDED|95.0|18.1|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||51.4|18.1|<0.001
91699761|NCT03569293|183294296|SUPERIORITY||Adjusted Response Rate Difference|56.6|||<|0.001|TWO_SIDED|95.0|42.0|71.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.1|42.0|<0.001
91699762|NCT03569293|183294296|SUPERIORITY||Adjusted Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|16.9|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.1|16.9|<0.001
91699763|NCT03569293|183294297|SUPERIORITY||Adjusted Response Rate Difference|50.9|||<|0.001|TWO_SIDED|95.0|35.1|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|35.1|<0.001
91699764|NCT03569293|183294297|SUPERIORITY||Adjusted Response Rate Difference|35.7|||<|0.001|TWO_SIDED|95.0|18.8|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|18.8|<0.001
91493079|NCT04115839|182857645|SUPERIORITY||Difference in response rates|15.4||||0.098|TWO_SIDED|95.0|-5.5|36.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||36.3|-5.5|0.098
91493080|NCT04115839|182857645|SUPERIORITY||Difference in response rates|-5.1||||0.4|TWO_SIDED|95.0|-21.1|11.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.0|-21.1|0.40
91493081|NCT04115839|182857645|SUPERIORITY||Difference in response rates|10.8||||0.26|TWO_SIDED|95.0|-12.6|34.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.3|-12.6|0.26
91493082|NCT04115839|182857645|SUPERIORITY||Difference in response rates|8.8||||0.39|TWO_SIDED|95.0|-14.6|32.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.2|-14.6|0.39
91493083|NCT04115839|182857645|SUPERIORITY||Difference in response rates|20.0||||0.088|TWO_SIDED|95.0|-6.9|46.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.9|-6.9|0.088
91493084|NCT04115839|182857645|SUPERIORITY||Difference in response rates|-7.0||||0.49|TWO_SIDED|95.0|-32.9|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.9|-32.9|0.49
91493085|NCT04115839|182857645|SUPERIORITY||Difference in response rates|28.3||||0.019|TWO_SIDED|95.0|2.4|54.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.2|2.4|0.019
91493086|NCT04115839|182857645|SUPERIORITY||Difference in response rates|2.9||||0.85|TWO_SIDED|95.0|-22.5|28.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.4|-22.5|0.85
91493087|NCT04115839|182857645|SUPERIORITY||Difference in response rates|25.9||||0.036|TWO_SIDED|95.0|-0.4|52.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||52.3|-0.4|0.036
91493088|NCT04115839|182857645|SUPERIORITY||Difference in response rates|6.1||||0.6|TWO_SIDED|95.0|-19.7|31.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.8|-19.7|0.60
91493089|NCT04115839|182857647|SUPERIORITY||Difference in response rates|6.0||||0.31|TWO_SIDED|95.0|-7.8|19.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.8|-7.8|0.31
91699765|NCT03569293|183294298|SUPERIORITY||Adjusted Response Rate Difference|54.4|||<|0.001|TWO_SIDED|95.0|37.4|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.3|37.4|<0.001
91699766|NCT03569293|183294298|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|19.8|56.4|||Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.4|19.8|<0.001
91699767|NCT03569293|183294299|SUPERIORITY||Adjusted Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|33.3|69.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.1|33.3|<0.001
91699768|NCT03569293|183294299|SUPERIORITY||Adjusted Response Rate Difference|28.1||||0.006|TWO_SIDED|95.0|8.0|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|8.0|0.006
91699769|NCT03569293|183294300|SUPERIORITY||Adjusted Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|19.9|42.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||42.5|19.9|<0.001
91493090|NCT04115839|182857647|SUPERIORITY||Difference in response rates|-2.8||||0.48|TWO_SIDED|95.0|-11.1|5.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.5|-11.1|0.48
91493091|NCT04115839|182857647|SUPERIORITY||Difference in response rates|2.5||||0.7|TWO_SIDED|95.0|-14.1|19.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.2|-14.1|0.70
91493092|NCT04115839|182857647|SUPERIORITY||Difference in response rates|-8.6||||0.17|TWO_SIDED|95.0|-20.7|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||3.6|-20.7|0.17
91493093|NCT04115839|182857647|SUPERIORITY||Difference in response rates|6.5||||0.34|TWO_SIDED|95.0|-12.5|25.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||25.6|-12.5|0.34
91493094|NCT04115839|182857647|SUPERIORITY||Difference in response rates|-0.3||||0.98|TWO_SIDED|95.0|-16.9|16.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.4|-16.9|0.98
91493095|NCT04115839|182857647|SUPERIORITY||Difference in response rates|18.7||||0.071|TWO_SIDED|95.0|-5.1|42.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.5|-5.1|0.071
91493096|NCT04115839|182857647|SUPERIORITY||Difference in response rates|-8.8||||0.27|TWO_SIDED|95.0|-27.7|10.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||10.1|-27.7|0.27
91493097|NCT04115839|182857647|SUPERIORITY||Difference in response rates|40.7||||0.002|TWO_SIDED|95.0|19.5|62.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.0|19.5|0.002
91493098|NCT04115839|182857647|SUPERIORITY||Difference in response rates|15.2||||0.082|TWO_SIDED|95.0|-2.3|32.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-2.3|0.082
91699770|NCT03569293|183294300|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.001|TWO_SIDED|95.0|6.9|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||24.6|6.9|0.001
91699771|NCT03569293|183294301|SUPERIORITY||LS Mean Difference|-42.42|||<|0.001|TWO_SIDED|95.0|-56.16|-28.68|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-28.68|-56.16|<0.001
91699772|NCT03569293|183294301|SUPERIORITY||LS Mean Difference|-33.88|||<|0.001|TWO_SIDED|95.0|-47.76|-19.99|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-19.99|-47.76|<0.001
91699773|NCT03569293|183294302|SUPERIORITY||LS Mean Difference|-41.84|||<|0.001|TWO_SIDED|95.0|-52.09|-31.58|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-31.58|-52.09|<0.001
91699774|NCT03569293|183294302|SUPERIORITY||LS Mean Difference|-37.84|||<|0.001|TWO_SIDED|95.0|-48.17|-27.52|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-27.52|-48.17|<0.001
91699775|NCT03569293|183294303|SUPERIORITY||Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|40.3|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|40.3|<0.001
91699776|NCT03569293|183294303|SUPERIORITY||Adjusted Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|34.8|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||65.3|34.8|<0.001
91699777|NCT03569293|183294304|SUPERIORITY||Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|21.0|69.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.2|21.0|<0.001
91493099|NCT04115839|182857649|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.5|-5.6|
91493100|NCT04115839|182857649|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||2.9|-2.9|
91493101|NCT04115839|182857649|SUPERIORITY||Difference in response rates|2.8|||||TWO_SIDED|95.0|-5.4|11.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.0|-5.4|
91493102|NCT04115839|182857649|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
91699778|NCT03569293|183294304|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.7|72.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.5|26.7|<0.001
91493103|NCT04115839|182857649|SUPERIORITY||Difference in response rates|12.7|||||TWO_SIDED|95.0|-4.2|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||29.5|-4.2|
91493104|NCT04115839|182857649|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-11.6|5.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||5.7|-11.6|
91493105|NCT04115839|182857649|SUPERIORITY||Difference in response rates|18.3|||||TWO_SIDED|95.0|0.2|36.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||36.3|0.2|
91493106|NCT04115839|182857649|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.6|-9.7|
91493107|NCT04115839|182857649|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-2.0|27.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.0|-2.0|
91699779|NCT03569293|183294305|SUPERIORITY||LS Mean Difference|-38.92|||<|0.001|TWO_SIDED|95.0|-49.54|-28.31|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-28.31|-49.54|<0.001
91699780|NCT03569293|183294305|SUPERIORITY||LS Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-43.44|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-21.96|-43.44|<0.001
91699781|NCT03569293|183294306|SUPERIORITY||Adjusted Response Rate Difference|51.7|||<|0.001|TWO_SIDED|95.0|31.7|71.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.8|31.7|<0.001
91699782|NCT03569293|183294306|SUPERIORITY||Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|26.7|62.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.8|26.7|<0.001
91699783|NCT03569293|183294307|SUPERIORITY||Adjusted Response Rate Difference|25.1||||0.006|TWO_SIDED|95.0|7.3|43.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.0|7.3|0.006
91699784|NCT03569293|183294307|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.093|TWO_SIDED|95.0|-2.6|34.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||34.2|-2.6|0.093
91493108|NCT04115839|182857649|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
91493109|NCT04115839|182857665|SUPERIORITY||Difference in response rates|9.5|||||TWO_SIDED|95.0|-10.4|29.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||29.4|-10.4|
91699785|NCT05072106|183294309|OTHER|Bioequivalence|Least-squares geometric mean ratio|96.83|||||TWO_SIDED|90.0|81.09|115.62|||||The reported results are the same as the ones reported in the CSR of the trial.|||115.62|81.09|
91699786|NCT05072106|183294310|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.81|||||TWO_SIDED|90.0|64.78|98.32||||||||98.32|64.78|
91699787|NCT05072106|183294311|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.2|||||TWO_SIDED|90.0|64.12|97.82||||||||97.82|64.12|
91699788|NCT05072106|183294312|OTHER|Bioequivalence|Least-squares geometric mean ratio|125.3|||||TWO_SIDED|90.0|101.71|154.36||||||||154.36|101.71|
91699789|NCT05072106|183294313|OTHER|Bioequivalence|Least-squares geometric mean ratio|106.79|||||TWO_SIDED|90.0|74.63|152.8||||||||152.8|74.63|
91699790|NCT05072106|183294314|OTHER|Bioequivalence|Least-squares geometric mean ratio|104.93|||||TWO_SIDED|90.0|69.49|158.44||||||||158.44|69.49|
91699791|NCT05072106|183294315|OTHER|bioequivalence|Least-squares geometric mean ratio|88.44|||||TWO_SIDED|90.0|65.62|119.19||||||||119.19|65.62|
91699792|NCT05072106|183294316|OTHER|bioequivalence|Least-squares geometric mean ratio|81.8|||||TWO_SIDED|90.0|54.8|119.96||||||||119.96|54.8|
91699793|NCT05072106|183294317|OTHER|bioequivalence|Least-squares geometric mean ratio|80.26|||||TWO_SIDED|90.0|54.26|118.72||||||||118.72|54.26|
91699794|NCT05072106|183294318|OTHER|bioequivalence|Least-squares geometric mean ratio|123.34|||||TWO_SIDED|90.0|83.36|182.49||||||||182.49|83.36|
91699795|NCT05072106|183294319|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
91699796|NCT05072106|183294320|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
91699797|NCT05072106|183294321|OTHER|bioequivalence|Least-squares geometric mean ratio|188.13|||||TWO_SIDED|90.0|132.93|266.26||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized Cmax.||266.26|132.93|
91699798|NCT05072106|183294322|OTHER|bioequivalence|Least-squares geometric mean ratio|245.46|||||TWO_SIDED|90.0|133.4|451.65||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized AUC0-t.||451.65|133.4|
91699799|NCT05072106|183294323|OTHER|bioequivalence|Least-squares geometric mean ratio|104.94|||||TWO_SIDED|90.0|94.07|117.05||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized Cmax.||117.05|94.07|
91493110|NCT04115839|182857665|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-12.5|26.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.7|-12.5|
91493111|NCT04115839|182857665|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-3.8|43.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||43.8|-3.8|
91493112|NCT04115839|182857665|SUPERIORITY||Difference in response rates|6.5|||||TWO_SIDED|95.0|-16.3|29.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||29.3|-16.3|
91493113|NCT04115839|182857665|SUPERIORITY||Difference in response rates|17.8|||||TWO_SIDED|95.0|-8.8|44.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||44.5|-8.8|
91493114|NCT04115839|182857665|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-22.9|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||28.8|-22.9|
91699800|NCT05072106|183294324|OTHER|bioequivalence|Least-squares geometric mean ratio|91.02|||||TWO_SIDED|90.0|71.39|116.04||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized AUC0-t.||116.04|71.39|
91493115|NCT04115839|182857665|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-0.5|50.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||50.6|-0.5|
91493116|NCT04115839|182857665|SUPERIORITY||Difference in response rates|14.7|||||TWO_SIDED|95.0|-10.5|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||39.9|-10.5|
91699801|NCT02276053|183294347|OTHER||Retention rate|86.0|||||TWO_SIDED|95.0|79.0|93.1|||||"Confidence intervals for the 6-month retention rate were calculated using Greenwood's formula.~Addition of a note: Not all patients had an Observation Period of 6 months."|The retention rate was derived using Kaplan-Meier methodology where patients who completed the study were censored at the date of last administration of LCM in the study.||93.1|79.0|
91699802|NCT02059434|183294359|SUPERIORITY_OR_OTHER||Least squares mean difference|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.06|0.149||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.149|0.060|<0.0001
91699803|NCT02059434|183294359|SUPERIORITY_OR_OTHER||Least squares mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.223||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.223|0.133|<0.0001
91699804|NCT00771264|183294366|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.||Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p\<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher's exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.||||0.05
91699805|NCT02928770|183294367|OTHER|||||||0.0559|||||||t-test, 2 sided|Comparison between baseline and experimental (Nastent) conditions||||||0.0559
91699806|NCT02759055|183294395|SUPERIORITY||Risk Ratio (RR)|1.003|||<|0.05|TWO_SIDED|95.0|0.998|1.008|||Mixed Models Analysis|||||1.008|0.998|<0.05
91699807|NCT01424514|183294405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.6|0.36||||||Placebo vs SB-705498 12 mg for 1 h in WM 0-60 TSS||0.36|-0.60|
91699808|NCT01424514|183294405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.45|0.51||||||Placebo vs SB-705498 12 mg for 24 h in WM 0-60 TSS||0.51|-0.45|
91699809|NCT01424514|183294405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.58|0.51||||||Placebo vs SB-705498 12 mg for 1 h in Maximum TSS||0.51|-0.58|
91699810|NCT01424514|183294405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.51|0.72||||||Placebo vs SB-705498 12 mg for 24 h in Maximum TSS||0.72|-0.51|
91493117|NCT04115839|182857665|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.6|-8.7|
91493118|NCT04115839|182857665|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-20.5|32.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-20.5|
91493119|NCT04115839|182857667|SUPERIORITY||Difference in response rates|9.0|||||TWO_SIDED|95.0|-6.0|23.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||23.9|-6.0|
91493120|NCT04115839|182857667|SUPERIORITY||Difference in response rates|3.3|||||TWO_SIDED|95.0|-9.4|15.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||15.9|-9.4|
91493121|NCT04115839|182857667|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-14.7|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||26.2|-14.7|
91493122|NCT04115839|182857667|SUPERIORITY||Difference in response rates|-5.5|||||TWO_SIDED|95.0|-23.4|12.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||12.4|-23.4|
91493123|NCT04115839|182857667|SUPERIORITY||Difference in response rates|1.3|||||TWO_SIDED|95.0|-21.5|24.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.1|-21.5|
91699811|NCT01424514|183294407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.3|0.54||||||Placebo vs SB-705498 12 mg for WM 0-60 TSS||0.54|-0.30|
91699812|NCT01424514|183294407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.39|0.57||||||Placebo vs SB-705498 12 mg for Maximum TSS||0.57|-0.39|
91699813|NCT01424514|183294411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.14|0.08||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 sneezing||0.08|-0.14|
91699814|NCT01424514|183294411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.13|0.09||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 sneezing||0.09|-0.13|
91699815|NCT01424514|183294411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.2|0.11||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 sneezing||0.11|-0.20|
91699816|NCT01424514|183294411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.28|0.14||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum sneezing||0.14|-0.28|
91699817|NCT01424514|183294411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.15|0.13||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum sneezing||0.13|-0.15|
91699818|NCT01424514|183294411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.16||||||Placebo vs SB-705498 12 mg for Day 1, 24 h in Maximum sneezing||0.16|-0.20|
91699819|NCT01424514|183294412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026|||TWO_SIDED|95.0|-0.03|0.07||||||Placebo vs SB-705498 12 mg for Day 1, 2 h in AR||0.07|-0.03|
91699820|NCT01424514|183294412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.13|-0.02||||||Placebo vs SB-705498 12 mg for Day 14, 2 h in AR||-0.02|-0.13|
91699821|NCT01424514|183294412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.04|0.08||||||Placebo vs SB-705498 12 mg for Day 14, 25 h in AR||0.08|-0.04|
91699822|NCT01424514|183294413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.26||||||Placebo vs SB-705498 12 mg for Day 14 in AR||0.26|-0.36|
91699823|NCT01424514|183294414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.06|0.6||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 TOSS||0.60|-0.06|
91699824|NCT01424514|183294414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.32|0.53||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 TOSS||0.53|-0.32|
91699825|NCT01424514|183294414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.22|0.63||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 TOSS||0.63|-0.22|
91699826|NCT01424514|183294414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.3|0.68||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum TOSS||0.68|-0.30|
91699827|NCT01424514|183294414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.34|0.86||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum TOSS||0.86|-0.34|
91699828|NCT01424514|183294414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.15|0.73||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in Maximum TOSS||0.73|-0.15|
91699829|NCT02653170|183294424|SUPERIORITY||difference-in-differences (DID) p-value|0.025||||0.025|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p\<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.025
91699830|NCT02653170|183294425|SUPERIORITY||difference-in-differences (DID) p-value|0.562||||0.562|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.562
91493124|NCT04115839|182857667|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.2|22.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.2|-22.2|
91699831|NCT02653170|183294426|SUPERIORITY|||||||0.789||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.789
91493125|NCT04115839|182857667|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-0.8|43.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||43.9|-0.8|
91699832|NCT02653170|183294427|SUPERIORITY||difference-in-differences (DID) p-value|0.042||||0.042|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis||The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.042
91699833|NCT02653170|183294428|SUPERIORITY|||||||0.993||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.993
91699834|NCT01473394|183294438|SUPERIORITY_OR_OTHER||Least square mean difference|-5.117|||<|1e-05|TWO_SIDED|95.0|-6.886|-3.347|||Mixed-effects model for repeated measure|||||-3.347|-6.886|<0.00001
91699835|NCT01473394|183294439|SUPERIORITY_OR_OTHER||Least square mean difference|-0.622|||<|1e-05|TWO_SIDED|95.0|-0.845|-0.399|||Mixed-effects model for repeated measure|||||-0.399|-0.845|<0.00001
91699836|NCT01473394|183294440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2||||0.0047|TWO_SIDED|95.0|3.0|17.4|||Cochran-Mantel-Haenszel||The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.|||17.4|3.0|0.0047
91699837|NCT03875482|183294459|SUPERIORITY||Mean Difference|59.0|||<|0.001|TWO_SIDED|95.0|48.4|69.6|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||69.6|48.4|<0.001
91699838|NCT03875482|183294460|SUPERIORITY||Mean Difference|68.5|||<|0.001|TWO_SIDED|95.0|57.2|79.7|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||79.7|57.2|<0.001
91699839|NCT03875482|183294461|SUPERIORITY||Mean Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints had been rejected.||46.2|26.2|<0.001
91699840|NCT03875482|183294462|SUPERIORITY||Mean Difference|37.1|||<|0.001|TWO_SIDED|95.0|27.1|47.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints and for the first secondary endpoint had been rejected.||47.2|27.1|<0.001
91699841|NCT03875482|183294463|SUPERIORITY||LS Mean Difference|-36.14|STANDARD_ERROR_OF_MEAN|4.956|<|0.001|TWO_SIDED|95.0|-45.936|-26.346|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 4~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-26.346|-45.936|<0.001
91731259|NCT02732145|183357790|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
91759164|NCT04038567|183411365|SUPERIORITY||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-3.26|2.42||||||Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.42|-3.26|
91759165|NCT04038567|183411365|SUPERIORITY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-1.35|4.33||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||4.33|-1.35|
91493126|NCT04115839|182857667|SUPERIORITY||Difference in response rates|20.6|||||TWO_SIDED|95.0|-1.4|42.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.6|-1.4|
91493127|NCT04115839|182857667|SUPERIORITY||Difference in response rates|17.5|||||TWO_SIDED|95.0|-7.7|42.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.7|-7.7|
91493128|NCT04115839|182857667|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-20.2|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||26.3|-20.2|
91493129|NCT04115839|182857670|SUPERIORITY||Difference in response rates|9.3|||||TWO_SIDED|95.0|-9.2|27.8||||||Week 2||27.8|-9.2|
91493130|NCT04115839|182857670|SUPERIORITY||Difference in response rates|3.8|||||TWO_SIDED|95.0|-13.5|21.0||||||Week 2||21.0|-13.5|
91493131|NCT04115839|182857670|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-16.8|28.2||||||Week 4||28.2|-16.8|
91493132|NCT04115839|182857670|SUPERIORITY||Difference in response rates|-2.4|||||TWO_SIDED|95.0|-23.7|19.0||||||Week 4||19.0|-23.7|
91493133|NCT04115839|182857670|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-21.1|31.8||||||Week 8||31.8|-21.1|
91493134|NCT04115839|182857670|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-31.0|19.3||||||Week 8||19.3|-31.0|
91528604|NCT02023879|182932962|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.9|||<|0.0001|TWO_SIDED|95.0|-43.9|-31.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.8|-43.9|<0.0001
91699842|NCT03875482|183294463|SUPERIORITY||LS Mean Difference|-59.97|STANDARD_ERROR_OF_MEAN|5.326|<|0.001|TWO_SIDED|95.0|-70.501|-49.439|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 16~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-49.439|-70.501|<0.001
91699843|NCT04777201|183294467|OTHER||Mean Difference (Final Values)|0.2||||0.7702|TWO_SIDED|95.0|-1.14|1.54|||Paired t-test||Difference is the result of study eye minus fellow eye.|No formal hypothesis testing was planned for this study. The paired t-tests were for reference purposes and thus not considered formal. The test was 2-sided, with the null hypothesis of no difference in percent change from baseline between the study eye and fellow eye in each patient.||1.54|-1.14|0.7702
91699844|NCT04777201|183294468|OTHER||Mean Difference (Final Values)|0.27||||0.6305|TWO_SIDED|95.0|-0.84|1.38|||Paired t-test||Difference is the result of study eye minus fellow eye.|No formal hypothesis testing was planned for this study. The paired t-tests were for reference purposes and thus not considered formal. The test was 2-sided, with the null hypothesis of no difference in percent change from baseline between the study eye and fellow eye in each patient.||1.38|-0.84|0.6305
91699845|NCT00507819|183294478|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Regression, Linear|||||||0.73
91699846|NCT00507819|183294479|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Regression, Linear|||||||0.37
91699847|NCT00507819|183294480|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
91699848|NCT00507819|183294481|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.04
91699849|NCT02357706|183294498|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs"|Mean Difference (Final Values)|1.24||||0.537|TWO_SIDED||||||t-test, 1 sided|||"Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test"||||0.537
91699850|NCT02357706|183294498|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|1.24||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
91699851|NCT02357706|183294499|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.205|TWO_SIDED||||||t-test, 1 sided|||||||0.205
91699852|NCT02357706|183294499|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.134|TWO_SIDED||||||t-test, 1 sided|||||||0.134
91699853|NCT02275780|183294522|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|3.913|||||TWO_SIDED|95.0|-1.59|9.415|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.415|-1.590|
91699854|NCT02275780|183294523|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|7.082|||||TWO_SIDED|95.0|0.508|13.656|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||13.656|0.508|
91493135|NCT04115839|182857670|SUPERIORITY||Difference in response rates|19.2|||||TWO_SIDED|95.0|-7.0|45.3||||||Week 12||45.3|-7.0|
91493136|NCT04115839|182857670|SUPERIORITY||Difference in response rates|8.8|||||TWO_SIDED|95.0|-16.9|34.6||||||Week 12||34.6|-16.9|
91493137|NCT04115839|182857670|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6||||||Week 16||45.6|-8.7|
91493138|NCT04115839|182857670|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-23.4|29.5||||||Week 16||29.5|-23.4|
91493139|NCT04115839|182857672|SUPERIORITY||Difference in response rates|-2.8|||||TWO_SIDED|95.0|-11.0|5.4||||||Week 2||5.4|-11.0|
91493140|NCT04115839|182857672|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-10.6|11.1||||||Week 2||11.1|-10.6|
91493141|NCT04115839|182857672|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-15.2|9.5||||||Week 4||9.5|-15.2|
91493142|NCT04115839|182857672|SUPERIORITY||Difference in response rates|-5.7|||||TWO_SIDED|95.0|-16.3|4.9||||||Week 4||4.9|-16.3|
91493143|NCT04115839|182857672|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-16.4|17.5||||||Week 8||17.5|-16.4|
91493144|NCT04115839|182857672|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-19.9|8.2||||||Week 8||8.2|-19.9|
91493145|NCT04115839|182857672|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-4.3|28.7||||||Week 12||28.7|-4.3|
91493146|NCT04115839|182857672|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6||||||Week 12||15.6|-9.7|
91493147|NCT04115839|182857672|SUPERIORITY||Difference in response rates|13.1|||||TWO_SIDED|95.0|-4.2|30.4||||||Week 16||30.4|-4.2|
91493148|NCT04115839|182857672|SUPERIORITY||Difference in response rates|12.1|||||TWO_SIDED|95.0|-4.5|28.7||||||Week 16||28.7|-4.5|
91493149|NCT04115839|182857675|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-3.8|40.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||40.7|-3.8|
91493150|NCT04115839|182857675|SUPERIORITY||Difference in response rates|7.3|||||TWO_SIDED|95.0|-13.5|28.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||28.2|-13.5|
91493151|NCT04115839|182857675|SUPERIORITY||Difference in response rates|16.0|||||TWO_SIDED|95.0|-8.5|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.4|-8.5|
91493152|NCT04115839|182857675|SUPERIORITY||Difference in response rates|15.5|||||TWO_SIDED|95.0|-9.4|40.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.3|-9.4|
91493153|NCT04115839|182857675|SUPERIORITY||Difference in response rates|18.8|||||TWO_SIDED|95.0|-7.5|45.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.0|-7.5|
91699855|NCT02275780|183294524|OTHER||Mean treatment difference|7.1|||||TWO_SIDED|95.0|-20.8|35.0|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||35.0|-20.8|
91699856|NCT02275780|183294525|OTHER||Mean treatment difference|17.4|||||TWO_SIDED|95.0|-14.5|49.3|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||49.3|-14.5|
91699857|NCT02275780|183294526|OTHER||Treatment Difference (mg/dL)|-14.61|||<|0.0001|TWO_SIDED|95.0|-18.15|-11.06|||ANCOVA|Terms for Baseline lipid level and treatment group||||-11.06|-18.15|<0.0001
91699858|NCT02275780|183294527|OTHER||Treatment Difference (mg/dL)|-19.34|||<|0.0001|TWO_SIDED|95.0|-23.33|-15.35|||ANCOVA|Terms for Baseline lipid level and treatment group||||-15.35|-23.33|<0.0001
91699859|NCT02275780|183294536|OTHER||Treatment Difference|4.169|||||TWO_SIDED|95.0|-1.404|9.743|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.743|-1.404|
91699860|NCT02275780|183294537|OTHER||Treatment Difference|7.606|||||TWO_SIDED|95.0|0.98|14.232|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||14.232|0.980|
91699861|NCT03960866|183294538|SUPERIORITY||Mean Difference (Net)|0.12||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
91699862|NCT03369067|183294542|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.010
91699863|NCT03369067|183294542|OTHER|||||||0.089||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.089
91493154|NCT04115839|182857675|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-32.5|20.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||20.7|-32.5|
91493155|NCT04115839|182857675|SUPERIORITY||Difference in response rates|40.5|||||TWO_SIDED|95.0|15.8|65.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||65.2|15.8|
91493156|NCT04115839|182857675|SUPERIORITY||Difference in response rates|23.5|||||TWO_SIDED|95.0|-2.5|49.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||49.5|-2.5|
91493157|NCT04115839|182857675|SUPERIORITY||Difference in response rates|20.1|||||TWO_SIDED|95.0|-6.8|46.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||46.9|-6.8|
91493158|NCT04115839|182857675|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-21.0|33.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.1|-21.0|
91493159|NCT04115839|182857679|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-31.0|31.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||31.0|-31.0|
91493160|NCT04115839|182857679|SUPERIORITY||Difference in response rates|22.0|||||TWO_SIDED|95.0|-12.8|56.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||56.7|-12.8|
91493161|NCT04115839|182857679|SUPERIORITY||Difference in response rates|4.3|||||TWO_SIDED|95.0|-37.9|46.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.5|-37.9|
91493162|NCT04115839|182857679|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-35.4|46.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.3|-35.4|
91493163|NCT04115839|182857679|SUPERIORITY||Difference in response rates|17.1|||||TWO_SIDED|95.0|-25.6|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-25.6|
91493164|NCT04115839|182857679|SUPERIORITY||Difference in response rates|-13.4|||||TWO_SIDED|95.0|-53.7|26.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||26.8|-53.7|
91493165|NCT04115839|182857679|SUPERIORITY||Difference in response rates|28.6|||||TWO_SIDED|95.0|-14.1|71.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.2|-14.1|
91493166|NCT04115839|182857679|SUPERIORITY||Difference in response rates|-0.4|||||TWO_SIDED|95.0|-40.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||39.9|-40.8|
91731260|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.253|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.2530
91493167|NCT04115839|182857681|SUPERIORITY||Difference in response rates|6.7||||0.55|TWO_SIDED|95.0|-21.3|34.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.7|-21.3|0.55
91493168|NCT04115839|182857681|SUPERIORITY||Difference in response rates|11.0||||0.24|TWO_SIDED|95.0|-17.4|39.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.3|-17.4|0.24
91493169|NCT04115839|182857681|SUPERIORITY||Difference in response rates|6.2||||0.47|TWO_SIDED|95.0|-22.6|35.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-22.6|0.47
91731261|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8338|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8338
91731262|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0019|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0019
91493170|NCT04115839|182857681|SUPERIORITY||Difference in response rates|10.5||||0.25|TWO_SIDED|95.0|-18.6|39.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||39.6|-18.6|0.25
91493171|NCT04115839|182857681|SUPERIORITY||Difference in response rates|18.6||||0.44|TWO_SIDED|95.0|-21.1|58.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||58.3|-21.1|0.44
91528605|NCT02023879|182932963|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.3|||<|0.0001|TWO_SIDED|95.0|-30.9|-21.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-30.9|<0.0001
91493172|NCT04115839|182857681|SUPERIORITY||Difference in response rates|-3.8||||0.68|TWO_SIDED|95.0|-38.4|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||30.8|-38.4|0.68
91493173|NCT04115839|182857681|SUPERIORITY||Difference in response rates|21.4||||0.33|TWO_SIDED|95.0|-19.4|62.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.2|-19.4|0.33
91493174|NCT04115839|182857681|SUPERIORITY||Difference in response rates|2.1||||0.98|TWO_SIDED|95.0|-33.9|38.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.1|-33.9|0.98
91493175|NCT04115839|182857683|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.5|24.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||24.5|-24.5|
91493176|NCT04115839|182857683|SUPERIORITY||Difference in response rates|-0.8|||||TWO_SIDED|95.0|-23.9|22.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.4|-23.9|
91493177|NCT04115839|182857683|SUPERIORITY||Difference in response rates|13.3|||||TWO_SIDED|95.0|-10.8|37.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||37.4|-10.8|
91493178|NCT04115839|182857683|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
91493179|NCT04115839|182857683|SUPERIORITY||Difference in response rates|-14.8|||||TWO_SIDED|95.0|-46.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||17.1|-46.6|
91493180|NCT04115839|182857683|SUPERIORITY||Difference in response rates|-15.5|||||TWO_SIDED|95.0|-46.3|15.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.2|-46.3|
91493181|NCT04115839|182857683|SUPERIORITY||Difference in response rates|21.4|||||TWO_SIDED|95.0|-13.0|55.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||55.8|-13.0|
91493182|NCT04115839|182857683|SUPERIORITY||Difference in response rates|4.6|||||TWO_SIDED|95.0|-22.3|31.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.5|-22.3|
91493183|NCT04115839|182857685|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.7|6.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||6.7|-6.7|
91493184|NCT04115839|182857685|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.6|23.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||23.3|-11.6|
91731263|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6541|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6541
91731264|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8224|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8224
91731265|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0064|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0064
91493185|NCT04115839|182857685|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-12.9|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.2|-12.9|
91493186|NCT04115839|182857685|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
91493187|NCT04115839|182857685|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.9|6.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||6.9|-6.9|
91493188|NCT04115839|182857685|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||23.6|-11.8|
91493189|NCT04115839|182857685|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||7.1|-7.1|
91493190|NCT04115839|182857685|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||23.6|-11.8|
91493191|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.066||0.19|TWO_SIDED|95.0|-0.22|0.04||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.04|-0.22|0.19
91493192|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.067||0.84|TWO_SIDED|95.0|-0.15|0.12||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.12|-0.15|0.84
91493193|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.073||0.3|TWO_SIDED|95.0|-0.22|0.07||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.07|-0.22|0.30
91493194|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.89|TWO_SIDED|95.0|-0.14|0.16||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.16|-0.14|0.89
91493195|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.096||0.064|TWO_SIDED|95.0|-0.37|0.01||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.01|-0.37|0.064
91493196|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.096||0.88|TWO_SIDED|95.0|-0.17|0.2||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.20|-0.17|0.88
91731266|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9723|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9723
91731267|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8161|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8161
91493197|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.099||0.023|TWO_SIDED|95.0|-0.43|-0.03||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||-0.03|-0.43|0.023
91699864|NCT03369067|183294542|OTHER|||||||0.024||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.024
91699865|NCT03369067|183294543|OTHER|||||||0.095||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.095
91699866|NCT03369067|183294543|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.104
91699867|NCT03369067|183294543|OTHER|||||||0.042||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.042
91699868|NCT03369067|183294544|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
91699869|NCT03369067|183294544|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699870|NCT03369067|183294544|OTHER|||||||0.065||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.065
91699871|NCT03369067|183294545|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699872|NCT03369067|183294545|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699873|NCT03369067|183294545|OTHER|||||||0.063||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.063
91699874|NCT03369067|183294546|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699875|NCT03369067|183294546|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91731268|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.1165|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.1165
91699876|NCT03369067|183294546|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699877|NCT03369067|183294547|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699878|NCT03369067|183294547|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699879|NCT03369067|183294547|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699880|NCT03369067|183294548|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699881|NCT03369067|183294548|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91493198|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.75|TWO_SIDED|95.0|-0.23|0.17||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0.17|-0.23|0.75
91699882|NCT03369067|183294548|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91528606|NCT02023879|182932964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|279.8|||<|0.0001|TWO_SIDED|95.0|29.1|2690.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2690.1|29.1|<0.0001
91699883|NCT03369067|183294549|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91731269|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6339|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6339
91731270|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9724|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9724
91731271|NCT02732145|183357791|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0016|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0016
91731272|NCT02732145|183357792|EQUIVALENCE|Question: Is there a difference in the age of patients from different groups?||||||0|||||||ANOVA|||Parameter: The difference in the age of patients from different groups.||||0.0000
91731273|NCT02732145|183357793|EQUIVALENCE|Is there a difference in the weight of patients from different groups?||||||0|||||||ANOVA|||The difference in the weight of patients from different groups.||||0.0000
91731274|NCT02732145|183357794|EQUIVALENCE|Is there a difference in the height of patients from different groups.||||||0.0557|||||||ANOVA|||The difference in the height of patients from different groups.||||0.0557
91528607|NCT02023879|182932965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|354.7|||<|0.0001|TWO_SIDED|95.0|36.2|3479.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3479.5|36.2|<0.0001
91699884|NCT03369067|183294549|OTHER|||||||0.062||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.062
91699885|NCT03369067|183294549|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91731275|NCT02732145|183357795|EQUIVALENCE|Is there a difference in the body mass index of patients from different groups.||||||0|||||||ANOVA|||The difference in the body mass index of patients from different groups.||||0.0000
91731276|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the incidence of patients older than 65 years in different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of patients older than 65 years between different groups.||||0.0000
91731277|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the incidence of menopausal patients among different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of menopausal patients among different groups.||||0.0000
91731278|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||||0.3708|||||||Chi-squared|||Parameter: The difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||0.3708
91731279|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the incidence of patients educated equally or less than 12 years among different groups?||||||0.018|||||||Chi-squared|||Parameter: The difference in the incidence of patients educated equally or less than 12 years among different groups.||||0.0180
91731280|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in marital status among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of marital status among patients from different groups.||||0.0000
91731281|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the nulliparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the nulliparity among patients from different groups.||||0.0000
91731282|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the multiparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the multiparity among patients from different groups.||||0.0000
91699886|NCT03369067|183294550|OTHER|||||||0.015||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.015
91699887|NCT03369067|183294550|OTHER|||||||0.199||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.199
91731283|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the number of abortions among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the number of abortions among patients from different groups.||||0.0000
91731284|NCT02732145|183357796|EQUIVALENCE|Question: Is there a difference in the using of contraception among patients from different groups?||||||0.1323|||||||Chi-squared|||Parameter: The difference in the using of contraception among patients from different groups.||||0.1323
91759166|NCT04038567|183411370|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-0.62|1.78||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.78|-0.62|
91699888|NCT03369067|183294550|OTHER|||||||0.025||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.025
91731285|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva among patients with vulvar discomfort?||||||0.3158|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) among patients with vulvar discomfort.||||0.3158
91731286|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the sharp pain of the vulva among patients with vulvar discomfort?||||||0.0007|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp pain in the vulva (stabbing, sticking, knife-like pain, paper-cuts pain) among patients with vulvar discomfort.||||0.0007
91731287|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvar dermatosis.||||0.0000
91731288|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvodynia.||||0.0000
91731289|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar burning among patients with vulvar discomfort?||||||0.0147|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar burning among patients with vulvar discomfort.||||0.0147
91731290|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar stinging among patients with vulvar discomfort?||||||0.8456|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar stinging among patients with vulvar discomfort.||||0.8456
91731291|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar soreness among patients with vulvar discomfort?||||||0.0076|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar soreness among patients with vulvar discomfort.||||0.0076
91731292|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of irritation of the vulva among the patients with vulvar discomfort?||||||0.0423|||||||Chi-squared|||Parameter: The difference in the incidence of irritation of the vulva among patients with vulvar discomfort.||||0.0423
91731293|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of the knife-like pain in the vulva among the patients with vulvar discomfort?||||||0.0457|||||||Chi-squared|||Parameter: The difference in the incidence of the knife-like pain in the vulva among patients with vulvar discomfort.||||0.0457
91731294|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of the paper-cuts pain of the vulva among the patients with vulvar discomfort?||||||0.043|||||||Chi-squared|||Parameter: The difference in the incidence of the paper-cuts pain of the vulva among patients with vulvar discomfort.||||0.0430
91731295|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of the stabbing of the vulva among the patients with vulvar discomfort?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of the stabbing of the vulva among patients with vulvar discomfort.||||0.0134
91731296|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of sticking of the vulva among the patients with vulvar discomfort?||||||0.0581|||||||Chi-squared|||Parameter: The difference in the incidence of sticking of the vulva among patients with vulvar discomfort.||||0.0581
91731297|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of itching of the vulva among the patients with vulvar discomfort?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the incidence of itching of the vulva among patients with vulvar discomfort.||||0.0002
91731298|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of the feeling of inflammation of the vulva among the patients with vulvar discomfort?|t-test proportion|0.0||||0.0852|TWO_SIDED||||||Chi-squared|||Parameter: The difference in the incidence of the feeling of inflammation of the vulva among patients with vulvar discomfort.||||0.0852
91731299|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the incidence of aching of the vulva among the patients with vulvar discomfort?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of aching of the vulva among patients with vulvar discomfort.||||0.0001
91731300|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the association of different symptoms of the vulva among the patients with vulvar discomfort?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of association of different vulvar symptoms among patients with vulvar discomfort.||||0.0000
91731301|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvar dermatosis.||||0.0000
91699889|NCT03369067|183294551|OTHER|||||||0.059||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.059
91699890|NCT03369067|183294551|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.064
91731302|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus stinging in the patients with vulvar dermatosis?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus stinging in patients with vulvar dermatosis.||||0.0008
91699891|NCT03369067|183294551|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
91731303|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvar dermatosis.||||0.0000
91731304|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvar dermatosis.||||0.0000
91699892|NCT03369067|183294552|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.034
91699893|NCT03369067|183294552|OTHER|||||||0.074||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.074
91699894|NCT03369067|183294552|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.034
91699895|NCT03369067|183294553|OTHER|||||||0.023||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.023
91699896|NCT03369067|183294553|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699897|NCT03369067|183294553|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
91699898|NCT03369067|183294554|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699899|NCT03369067|183294554|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699900|NCT03369067|183294554|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699901|NCT03369067|183294555|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699902|NCT03369067|183294555|OTHER|||||||0.081||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.081
91699903|NCT03369067|183294555|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699904|NCT03369067|183294556|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699905|NCT03369067|183294556|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91759167|NCT04038567|183411370|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-0.47|1.92||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.92|-0.47|
91699906|NCT03369067|183294556|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699907|NCT03369067|183294557|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699908|NCT03369067|183294557|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699909|NCT03369067|183294557|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699910|NCT03369067|183294558|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699911|NCT03369067|183294558|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699912|NCT03369067|183294558|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699913|NCT03369067|183294559|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699914|NCT03369067|183294559|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699915|NCT03369067|183294559|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91528608|NCT02023879|182932966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|126.0|||<|0.0001|TWO_SIDED|95.0|20.0|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|20.0|<0.0001
91699916|NCT03369067|183294560|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699917|NCT03369067|183294560|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699918|NCT03369067|183294560|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699919|NCT03369067|183294561|OTHER|||||||0.124||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.124
91699920|NCT03369067|183294561|OTHER|||||||0.187||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.187
91699921|NCT03369067|183294561|OTHER|||||||0.04||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.040
91699922|NCT03369067|183294562|OTHER|||||||0.108||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.108
91699923|NCT03369067|183294562|OTHER|||||||0.053||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.053
91699924|NCT03369067|183294562|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.010
91699925|NCT03369067|183294563|OTHER|||||||0.08||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.080
91699926|NCT03369067|183294563|OTHER|||||||0.038||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.038
91699927|NCT03369067|183294563|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
91699928|NCT03369067|183294564|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.111
91699929|NCT03369067|183294564|OTHER|||||||0.13||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.130
91699930|NCT03369067|183294564|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
91699931|NCT03369067|183294565|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699932|NCT03369067|183294565|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699933|NCT03369067|183294565|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699934|NCT03369067|183294566|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699935|NCT03369067|183294566|OTHER|||||||0.044||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.044
91699936|NCT03369067|183294566|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91493199|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.005|TWO_SIDED|95.0|-0.51|-0.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||-0.10|-0.51|0.005
91493200|NCT04115839|182857693|SUPERIORITY||LS Mean Treatment Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.105||0.54|TWO_SIDED|95.0|-0.27|0.14||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||0.14|-0.27|0.54
91493201|NCT04115839|182857695|SUPERIORITY||LS Mean Treatment Difference|1.3|STANDARD_ERROR_OF_MEAN|1.64||0.43|TWO_SIDED|95.0|-1.9|4.5||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||4.5|-1.9|0.43
91731305|NCT02732145|183357797|SUPERIORITY|||||||0||||||There was a statistically significant difference at p\<0.001. Patients with vulvar dermatosis had significantly more often itching than the feeling of inflammation of the vulva.|t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
91731306|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvar dermatosis.||||0.0000
91731307|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvar dermatosis.||||0.0000
91731308|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvar dermatosis.||||0.0000
91731309|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvar dermatosis.||||0.0000
91731310|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
91731311|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvar dermatosis.||||0.0000
91731312|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvar dermatosis?||||||0.8591|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvar dermatosis.||||0.8591
91528609|NCT02023879|182932967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|141.5|||<|0.0001|TWO_SIDED|95.0|22.2|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|22.2|<0.0001
91731313|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvar dermatosis?||||||0.009|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvar dermatosis.||||0.0090
91731314|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvar dermatosis?||||||0.0212|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvar dermatosis.||||0.0212
91731315|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0.0057|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0057
91731316|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0977|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0977
91699937|NCT03369067|183294567|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699938|NCT03369067|183294567|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699939|NCT03369067|183294567|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699940|NCT03369067|183294568|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699941|NCT03369067|183294568|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699942|NCT03369067|183294568|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699943|NCT03369067|183294569|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699944|NCT03369067|183294569|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699945|NCT03369067|183294569|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699946|NCT03369067|183294570|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699947|NCT03369067|183294570|OTHER|||||||0.141||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.141
91699948|NCT03369067|183294570|OTHER|||||||0.149||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.149
91699949|NCT03369067|183294571|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699950|NCT03369067|183294571|OTHER|||||||0.094||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.094
91699951|NCT03369067|183294571|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699952|NCT03369067|183294572|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
91699953|NCT03369067|183294572|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699954|NCT03369067|183294572|OTHER|||||||0.033||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.033
91699955|NCT03369067|183294573|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
91699956|NCT03369067|183294573|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699957|NCT03369067|183294573|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.111
91699958|NCT03369067|183294574|OTHER|||||||0.118||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.118
91699959|NCT03369067|183294574|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699960|NCT03369067|183294574|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699961|NCT03369067|183294575|OTHER|||||||0.116||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.116
91699962|NCT03369067|183294575|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699963|NCT03369067|183294575|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699964|NCT03369067|183294576|OTHER|||||||0.005||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.005
91699965|NCT03369067|183294576|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699966|NCT03369067|183294576|OTHER|||||||0.193||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.193
91699967|NCT03369067|183294577|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699968|NCT03369067|183294577|OTHER|||||||0.106||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.106
91699969|NCT03369067|183294577|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699970|NCT03369067|183294578|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699971|NCT03369067|183294578|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699972|NCT03369067|183294578|OTHER|||||||0.157||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.157
91699973|NCT03369067|183294579|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699974|NCT03369067|183294579|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699975|NCT03369067|183294579|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699976|NCT03369067|183294580|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699977|NCT03369067|183294580|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699978|NCT03369067|183294580|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699979|NCT03369067|183294581|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699980|NCT03369067|183294581|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699981|NCT03369067|183294581|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699982|NCT03369067|183294582|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699983|NCT03369067|183294582|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699984|NCT03369067|183294582|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699985|NCT03369067|183294583|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699986|NCT03369067|183294583|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699987|NCT03369067|183294583|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
91699988|NCT03369067|183294584|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699989|NCT03369067|183294584|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699990|NCT03369067|183294584|OTHER|||||||0.073||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.073
91699991|NCT03369067|183294585|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699992|NCT03369067|183294585|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699993|NCT03369067|183294585|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.064
91699994|NCT03369067|183294586|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699995|NCT03369067|183294586|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699996|NCT03369067|183294586|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699997|NCT03369067|183294587|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91731317|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0143|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0143
91493202|NCT04115839|182857695|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.64||0.81|TWO_SIDED|95.0|-3.6|2.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||2.9|-3.6|0.81
91493203|NCT04115839|182857695|SUPERIORITY||LS Mean Treatment Difference|5.1|STANDARD_ERROR_OF_MEAN|2.43||0.04|TWO_SIDED|95.0|0.2|9.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||9.9|0.2|0.040
91699998|NCT03369067|183294587|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91699999|NCT03369067|183294587|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.104
91700000|NCT03369067|183294588|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91700001|NCT03369067|183294588|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91700002|NCT03369067|183294588|OTHER|||||||0.198||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.198
91700003|NCT03369067|183294589|OTHER|||||||0.105||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.105
91700004|NCT03369067|183294589|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
91731318|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
91493204|NCT04115839|182857695|SUPERIORITY||LS Mean Treatment Difference|1.4|STANDARD_ERROR_OF_MEAN|2.41||0.58|TWO_SIDED|95.0|-3.4|6.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.1|-3.4|0.58
91700005|NCT03369067|183294589|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91700006|NCT03369067|183294590|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91700007|NCT03369067|183294590|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91700008|NCT03369067|183294590|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
91700009|NCT05129475|183294604|OTHER||Ratio of Adjusted Geometric Means|120.9|||||TWO_SIDED|90.0|109.3|133.74|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||133.74|109.30|
91700010|NCT05129475|183294605|OTHER||Ratio of Adjusted Geometric Means|119.67|||||TWO_SIDED|90.0|108.75|131.68|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||131.68|108.75|
91700011|NCT05129475|183294606|OTHER||Ratio of Adjusted Geometric Means|161.01|||||TWO_SIDED|90.0|139.05|186.44|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||186.44|139.05|
91700012|NCT01899742|183294615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.001|TWO_SIDED|95.0|0.045|0.131|||Mixed Models Analysis|||||0.131|0.045|<0.001
91700013|NCT01899742|183294616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.004|TWO_SIDED|95.0|0.024|0.122|||Mixed Models Analysis|||||0.122|0.024|0.004
91700014|NCT00135798|183294617|SUPERIORITY_OR_OTHER|||||||0.0477||95.0||||One-sided test|Fisher Exact|||ITT analysis of pTVR: 0/13 Standard care vs. 11/46 Combined LADR-treated groups||||0.0477
91700015|NCT00135798|183294617|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 5/24 Genotypes 1,4,6 vs 6/22 Genotypes 2,3||||0.6090
91700016|NCT00135798|183294618|SUPERIORITY_OR_OTHER|||||||0.2014||95.0||||One-sided test|Fisher Exact|||ITT analysis of CVR: 1/16 Standard care vs. 12/63 Combined LADR-treated groups||||0.2014
91493205|NCT04115839|182857699|SUPERIORITY||LS Mean Treatment Difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4|TWO_SIDED|95.0|-1.2|3.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.1|-1.2|0.40
91493206|NCT04115839|182857699|SUPERIORITY||LS Mean Treatment Difference|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.4|-1.0|0.28
91528610|NCT02023879|182932968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.6||||0.0002|TWO_SIDED|95.0|-29.8|-9.4||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-9.4|-29.8|0.0002
91731319|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.682|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.6820
91731320|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
91731321|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvodynia.||||0.0000
91731322|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvodynia?||||||0.0344|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvodynia.||||0.0344
91731323|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvodynia?||||||0.0023|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvodynia.||||0.0023
91731324|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus itching in the patients with vulvodynia?||||||0.5675|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus itching in patients with vulvodynia.||||0.5675
91731325|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvodynia?||||||0.0037|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvodynia.||||0.0037
91731326|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvodynia?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvodynia.||||0.0005
91731327|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvodynia.||||0.0000
91731328|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvodynia?||||||0.1201|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvodynia.||||0.1201
91731329|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvodynia?||||||0.0123|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvodynia.||||0.0123
91731330|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus the feeling of inflammation in the patients with vulvodynia?||||||0.0188|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvodynia.||||0.0188
91731331|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvodynia?||||||0.003|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvodynia.||||0.0030
91731332|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvodynia?||||||0.2155|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvodynia.||||0.2155
91731333|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvodynia?||||||0.1508|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvodynia.||||0.1508
91731334|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvodynia?||||||0.6364|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvodynia.||||0.6364
91493207|NCT04115839|182857699|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.46||0.011|TWO_SIDED|95.0|0.9|6.7||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.7|0.9|0.011
91493208|NCT04115839|182857699|SUPERIORITY||LS Mean Treatment Difference|2.1|STANDARD_ERROR_OF_MEAN|1.45||0.14|TWO_SIDED|95.0|-0.7|5.0||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||5.0|-0.7|0.14
91700017|NCT00135798|183294618|SUPERIORITY_OR_OTHER|||||||0.9513||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 6/31 Genotypes 1,4,6 vs 6/32 Genotypes 2,3||||0.9513
91700018|NCT00135798|183294619|SUPERIORITY_OR_OTHER|||||||0.0274||95.0||||One-sided test|Fisher Exact|||PP analysis of pTVR: 0/13 Standard care vs. 11/44 Combined LADR-treated groups||||0.0274
91700019|NCT00135798|183294619|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Chi-squared|||PP analysis of LADR-treated: 5/23 G1,4,6 vs 6/21 G2,3||||0.6011
91700020|NCT00135798|183294620|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||One-sided test|Fisher Exact|||PP analysis of CVR: 0/20 Standard care vs. 13/59 Combined LADR-treated groups||||0.0153
91700021|NCT00135798|183294620|SUPERIORITY_OR_OTHER|||||||0.8065||95.0|||||Chi-squared|||PP analysis of LADR-treated: 7/30 G1,4,6 vs 6/29 G2,3||||0.8065
91700022|NCT01663779|183294724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.01|TWO_SIDED|95.0|3.0|7.0|||Chi-squared|||||7|3|<0.01
91700023|NCT05845567|183294733|SUPERIORITY||ratio of the Geometric LSmeans|139.43|||||TWO_SIDED|90.0|129.73|149.86||||||||149.86|129.73|
91493209|NCT01751867|182857712|SUPERIORITY_OR_OTHER||ORR %|29.4||||0.003|TWO_SIDED|95.0|15.1|47.5|||Exact binomial proportion test||ORR % = Number of participants who achieved response divided by total ITT participants|Null Hypothesis: threshold for statistical significance = 10%||47.5|15.1|0.003
91700024|NCT05845567|183294734|SUPERIORITY||ratio of the Geometric LSmeans|117.97|||||TWO_SIDED|90.0|112.24|124.0||||||||124.00|112.24|
91700025|NCT05845567|183294735|SUPERIORITY||ratio of the Geometric LSmeans|117.88|||||TWO_SIDED|90.0|112.13|123.92||||||||123.92|112.13|
91493210|NCT01751867|182857712|SUPERIORITY_OR_OTHER||ORR %|25.5|||<|0.001|TWO_SIDED|95.0|17.2|35.3|||Exact binomial proportion test|||Null Hypothesis: threshold for statistical significance = 10%||35.3|17.2|<0.001
91493211|NCT03095066|182857755|SUPERIORITY||Difference in LS Mean|-1.7||||0.405|TWO_SIDED|95.0|-5.8|2.4||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Treatment differences in each stage were estimated by the Mixed Model Repeated Measures (MMRM).||2.4|-5.8|0.405
91493212|NCT03095066|182857756|SUPERIORITY||Difference in LS Mean|-0.7||||0.921|TWO_SIDED|95.0|-15.3|13.9||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Treatment differences in each stage were estimated by the MMRM.||13.9|-15.3|0.921
91700026|NCT01869699|183294768|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.002|TWO_SIDED|95.0|-0.76|-0.18|||ANCOVA|||We estimated that 20 patients per group would provide 80% power for detecting a difference in means of 0.6 degrees Celsius, with a pooled SD of 0.67 degrees, using a two group t test and a two sided alpha level of 0.05. A previous RCT of IV acetaminophen in healthy male volunteers with induced fever found a core temperature difference of 0.60 degrees with a common SD of 0.67 degrees Celsius.||-0.18|-0.76|0.002
91700027|NCT01869699|183294769|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.03|TWO_SIDED|95.0|-10.0|-1.0|||ANCOVA|||||-1|-10|0.03
91700028|NCT01869699|183294770|SUPERIORITY||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.0|-8.0|||ANCOVA|||||-8|-25|<0.001
91700029|NCT01869699|183294771|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.42|TWO_SIDED|95.0|-4.0|12.0|||ANCOVA|||||12|-4|0.42
91700030|NCT01869699|183294772|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||||-0.3|-1|0.002
91700031|NCT01869699|183294773|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.001|TWO_SIDED|95.0|-38.0|-10.0|||ANCOVA|||||-10|-38|0.001
91700032|NCT01869699|183294774|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.02|TWO_SIDED|95.0|-15.0|-1.0|||ANCOVA|||||-1|-15|0.02
91700033|NCT01041976|183294846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91700034|NCT01041976|183294847|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91700035|NCT01252563|183294872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
91700036|NCT01252563|183294872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
91700037|NCT01252563|183294872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
91700038|NCT01252563|183294872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
91700039|NCT01252563|183294873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
91700040|NCT01252563|183294873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
91700041|NCT01252563|183294873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
91700042|NCT01252563|183294873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
91700043|NCT01252563|183294876|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Complication. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events."||||<0.001
91700044|NCT01252563|183294877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events."||||<0.001
91700045|NCT01252563|183294878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Chi-squared|||"The risk factor tested was angina pectoris as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events."||||0.036
91700046|NCT01252563|183294879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||"The risk factor tested was dyslipidaemia as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events."||||0.020
91700047|NCT01252563|183294880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Chi-squared|||"The risk factor tested was antihypertensive as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events."||||0.049
91700048|NCT01252563|183294881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||Chi-squared|||"The risk factor tested was ARB as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events."||||0.043
91700049|NCT01252563|183294882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was diabetes mellitus as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy."||||<0.001
91700050|NCT01252563|183294883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was chronic kidney disease as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy."||||<0.001
91700051|NCT01252563|183294884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Chi-squared|||"The risk factor tested was myocardial infarction as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy."||||0.039
91700052|NCT01252563|183294885|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was metabolic syndrome as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy."||||<0.001
91700053|NCT01252563|183294886|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was ambulatory SBP at baseline. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines."||||<0.001
91700054|NCT01252563|183294888|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
91700055|NCT01252563|183294888|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
91528611|NCT02023879|182932969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.9||||0.0892|TWO_SIDED|95.0|-17.1|1.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.2|-17.1|0.0892
91731335|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvodynia?||||||0.5277|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvodynia.||||0.5277
91731336|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.2041|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.2041
91731337|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.0412|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0412
91731338|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvodynia who had sharp vulvar pain?||||||0.7978|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvodynia who had sharp vulvar pain.||||0.7978
91731339|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.3094|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.3094
91731340|NCT02732145|183357797|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.073|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0730
91731341|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis and vulvodynia?||||||0.4038|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis or vulvodynia.||||0.4038
91731342|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis and vulvodynia?||||||0.7299|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis or vulvodynia.||||0.7299
91528612|NCT00874432|182932977|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||p-value for CBPWV between CKD and Control groups||||0.685
91731343|NCT02732145|183357797|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis and vulvodynia?||||||0.7241|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis or vulvodynia.||||0.7241
91731344|NCT02732145|183357798|EQUIVALENCE|Question: Is there a difference in the sexual activity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the sexual activity among patients from different groups.||||0.0000
91731345|NCT02732145|183357798|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups?||||||0.0006|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups.||||0.0006
91731346|NCT02732145|183357798|EQUIVALENCE|Question: Is there a difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups.||||0.0000
91731347|NCT02732145|183357799|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia among patients from different groups.||||0.0000
91731348|NCT02732145|183357799|EQUIVALENCE|Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||||0.2999|||||||Chi-squared|||Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||0.2999
91731349|NCT02732145|183357800|EQUIVALENCE|Question: Is there a difference in the incidence of the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0000
91731350|NCT02732145|183357800|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis?||||||0.0347|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis.||||0.0347
91528613|NCT00874432|182932977|SUPERIORITY|||||||0.739|||||||t-test, 2 sided|||p-value for CRPWV between CKD and Control groups||||0.739
91700056|NCT01252563|183294888|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
91731351|NCT02732145|183357800|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.7068|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.7068
91700057|NCT01252563|183294888|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
91700058|NCT01252563|183294889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
91700059|NCT01252563|183294889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
91700060|NCT01252563|183294889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
91700061|NCT01252563|183294889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
91700062|NCT03036098|183294976|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0032|TWO_SIDED|95.0|0.64|0.97|||Log Rank|Stratified weighted log-rank test||||0.97|0.64|0.0032
91700063|NCT03036098|183294983|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0018|TWO_SIDED|95.0|0.59|0.88|||Log Rank|Stratified weighted log-rank test||||0.88|0.59|0.0018
91700064|NCT03036098|183294984|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0171|TWO_SIDED|95.0|0.63|0.96|||Log Rank|Stratified weighted log-rank test||||0.96|0.63|0.0171
91700065|NCT01632904|183295007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.139|TWO_SIDED|95.0|0.82|4.04|||Chi-squared|||||4.04|0.82|0.139
91700066|NCT04769466|183295015|OTHER|||||||0.02|||||||t-test, 1 sided|||T-Test||||0.020
91700067|NCT04769466|183295016|OTHER|||||||0.223|||||||t-test, 1 sided|||T-Test||||0.223
91700068|NCT04769466|183295017|OTHER|||||||0.036|||||||t-test, 2 sided|||T-Test||||0.036
91700069|NCT04769466|183295018|OTHER|||||||0.131|||||||t-test, 1 sided|||||||0.131
91700070|NCT04769466|183295019|OTHER|||||||0.351|||||||t-test, 1 sided|||||||0.351
91700071|NCT04769466|183295020|OTHER|||||||0.08|||||||t-test, 1 sided|||||||0.08
91731352|NCT02732145|183357800|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.0025|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0025
91731353|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis.||||0.0000
91700072|NCT04769466|183295021|OTHER|||||||0.4|||||||t-test, 1 sided|||T-Test||||0.400
91700073|NCT04769466|183295023|OTHER|||||||0.011|||||||t-test, 2 sided|||||||0.011
91700074|NCT04769466|183295025|OTHER|||||||0.459|||||||t-test, 1 sided|||||||0.459
91700075|NCT04769466|183295026|OTHER|||||||0.033|||||||t-test, 1 sided|||||||0.033
91700076|NCT04769466|183295027|OTHER|||||||0.103|||||||t-test, 1 sided|||||||0.103
91700077|NCT04769466|183295028|OTHER|||||||0.494|||||||t-test, 1 sided|||||||0.494
91700078|NCT04769466|183295029|OTHER|||||||0.214|||||||t-test, 1 sided|||||||0.214
91700079|NCT04769466|183295030|OTHER|||||||0.199|||||||t-test, 1 sided|||||||0.199
91700080|NCT04769466|183295033|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91700081|NCT04769466|183295034|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91700082|NCT04542499|183295039|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||1.653|0.553|<0.0001
91700083|NCT04542499|183295040|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||-0.410|-1.475|0.0006
91700084|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.188||0.2216|TWO_SIDED|95.0|-0.6|0.139||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.139|-0.600|0.2216
91700085|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|0.099|STANDARD_ERROR_OF_MEAN|0.211||0.6379|TWO_SIDED|95.0|-0.316|0.515||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.515|-0.316|0.6379
91700086|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|0.582|STANDARD_ERROR_OF_MEAN|0.234||0.0132|TWO_SIDED|95.0|0.122|1.042||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||1.042|0.122|0.0132
91700087|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|0.358|STANDARD_ERROR_OF_MEAN|0.236||0.1299|TWO_SIDED|95.0|-0.106|0.821||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||0.821|-0.106|0.1299
91700088|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|0.698|STANDARD_ERROR_OF_MEAN|0.257||0.0068|TWO_SIDED|95.0|0.194|1.202||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||1.202|0.194|0.0068
91700089|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|0.969|STANDARD_ERROR_OF_MEAN|0.254||0.0002|TWO_SIDED|95.0|0.469|1.469||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||1.469|0.469|0.0002
91700090|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|0.879|STANDARD_ERROR_OF_MEAN|0.259||0.0008|TWO_SIDED|95.0|0.369|1.389||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||1.389|0.369|0.0008
91700091|NCT04542499|183295041|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.653|0.553|<0.0001
91700092|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|0.108|STANDARD_ERROR_OF_MEAN|0.18||0.5471|TWO_SIDED|95.0|-0.245|0.461||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.461|-0.245|0.5471
91700093|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-0.237|STANDARD_ERROR_OF_MEAN|0.205||0.2488|TWO_SIDED|95.0|-0.64|0.166||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.166|-0.640|0.2488
91700094|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-0.818|STANDARD_ERROR_OF_MEAN|0.221||0.0002|TWO_SIDED|95.0|-1.252|-0.384||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||-0.384|-1.252|0.0002
91700095|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.227||0.001|TWO_SIDED|95.0|-1.199|-0.307||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||-0.307|-1.199|0.0010
91700096|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-0.904|STANDARD_ERROR_OF_MEAN|0.254||0.0004|TWO_SIDED|95.0|-1.403|-0.405||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||-0.405|-1.403|0.0004
91700097|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-1.024|STANDARD_ERROR_OF_MEAN|0.256|<|0.0001|TWO_SIDED|95.0|-1.528|-0.52||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||-0.520|-1.528|<0.0001
91700098|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-0.979|STANDARD_ERROR_OF_MEAN|0.261||0.0002|TWO_SIDED|95.0|-1.493|-0.465||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||-0.465|-1.493|0.0002
91700099|NCT04542499|183295042|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.410|-1.475|0.0006
91700100|NCT04542499|183295043|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3265|TWO_SIDED|95.0|-0.4|1.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part I||1.2|-0.4|0.3265
91700101|NCT04542499|183295043|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52||0.0203|TWO_SIDED|95.0|-2.2|-0.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part II||-0.2|-2.2|0.0203
91700102|NCT04542499|183295043|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.96||0.0118|TWO_SIDED|95.0|-4.3|-0.5||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part III||-0.5|-4.3|0.0118
91493213|NCT03095066|182857757|SUPERIORITY||Difference in LS Mean|-0.7||||0.15|TWO_SIDED|95.0|-1.7|0.3||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Baseline to Week 6: Treatment differences in each stage were estimated by the MMRM.||0.3|-1.7|0.150
91493214|NCT03095066|182857757|SUPERIORITY||Difference in LS Mean|0.2||||0.921|TWO_SIDED|95.0|-4.3|4.7||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Week 7 to Week 12: Treatment differences in each stage were estimated by the MMRM.||4.7|-4.3|0.921
91493215|NCT03095066|182857758|SUPERIORITY||Difference in LS Mean|0.3||||0.702|TWO_SIDED|95.0|-1.3|1.9||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Baseline to Week 6: Treatment differences in each stage were estimated by the MMRM.||1.9|-1.3|0.702
91700103|NCT04281784|183295085|SUPERIORITY||Risk Difference (RD)|0.0421||||0.027|TWO_SIDED|95.0|0.0047|0.0777||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Occurrence of discussion regressed on randomization condition, adjusted for ADRD status, hospital, and time between study start \& randomization date.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.0777|0.0047|0.027
91700104|NCT04281784|183295087|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.246||0.75|TWO_SIDED|95.0|-0.56|0.404|||Regression, Linear|Outcome (days alive and out of ICU) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.404|-0.560|0.750
91700105|NCT04281784|183295088|SUPERIORITY||Median Difference (Final Values)|-0.361|STANDARD_ERROR_OF_MEAN|0.357||0.312|TWO_SIDED|95.0|-1.06|0.338|||Regression, Linear|Outcome (days alive and out of hospital) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.338|-1.060|0.312
91700106|NCT04281784|183295089|SUPERIORITY||Risk Difference (RD)|0.012||||0.475|TWO_SIDED|95.0|-0.02|0.043||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Readmission (0, 1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.043|-0.020|0.475
91700107|NCT04281784|183295090|SUPERIORITY||Risk Difference (RD)|-0.009||||0.61|TWO_SIDED|95.0|-0.043|0.025||two-sided test, no adjustment for multiple comparisons|Regression, Linear|ICU care (0,1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.025|-0.043|0.610
91700108|NCT04281784|183295091|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|0.022|STANDARD_ERROR_OF_MEAN|0.058||0.71|TWO_SIDED|95.0|-0.092|0.135|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.135|-0.092|0.710
91700109|NCT04281784|183295092|SUPERIORITY||Risk Difference (RD)|0.487|STANDARD_ERROR_OF_MEAN|0.899||0.588|TWO_SIDED|95.0|-1.275|2.249||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Died within 30 days after randomization regressed on randomization condition (0=usual care, 1=intervention) adjusted for hospital and ADRD status|Robust standard error|Usual care=reference group; intervention arm = comparison group||2.249|-1.275|0.588
91700110|NCT04281784|183295093|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|-0.028|STANDARD_ERROR_OF_MEAN|0.069||0.685|TWO_SIDED|95.0|-0.162|0.107|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.107|-0.162|0.685
91700111|NCT04488497|183295105|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
91700112|NCT04488497|183295106|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91700113|NCT04488497|183295107|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
91700114|NCT04488497|183295108|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91700115|NCT04488497|183295109|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
91700116|NCT04488497|183295110|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
91700117|NCT04488497|183295111|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
91700118|NCT04322539|183295112|SUPERIORITY||Stratified Hazard Ratio|0.662|||<|0.001|TWO_SIDED|95.0|0.549|0.8||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.800|0.549|< .001
91493216|NCT03095066|182857758|SUPERIORITY||Difference in LS Mean|2.0||||0.469|TWO_SIDED|95.0|-3.6|7.6||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Week 7 to Week 12: Treatment differences in each stage were estimated by the MMRM.||7.6|-3.6|0.469
91528614|NCT00874432|182932977|SUPERIORITY|||||||0.471|||||||t-test, 2 sided|||p-value for CFPWV between CKD and Control groups||||0.471
91700119|NCT04322539|183295113|SUPERIORITY||Hazard Ratio (HR)|0.321|||<|0.001|TWO_SIDED|95.0|0.267|0.386||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.386|0.267|< .001
91700120|NCT04322539|183295114|SUPERIORITY||Adjusted difference|1.5||||0.059|TWO_SIDED|95.0|0.4|2.7||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||2.7|0.4|.059
91731354|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons?||||||0.6552|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons.||||0.6552
91731355|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis.||||0.0002
91731356|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle?||||||0.2877|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle.||||0.2877
91700121|NCT04322539|183295115|SUPERIORITY||Adjusted difference|39.4|||<|0.001|TWO_SIDED|95.0|32.8|46.0||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||46.0|32.8|<.001
91700122|NCT04322539|183295121|OTHER|||||||0.06|||||||Wald test|||CminSS Based on the Starting Dose for OS Exposure-Response Analyses||||0.0600
91700123|NCT04322539|183295121|OTHER|||||||0.8065|||||||Wald test|||CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses||||0.8065
91700124|NCT04322539|183295122|OTHER|||||||0.265|||||||Wald test|||CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.||||0.265
91700125|NCT04322539|183295122|OTHER|||||||0.0159|||||||Wald test|||CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.||||0.0159
91700126|NCT04322539|183295122|OTHER|||||||0.484|||||||Wald test|||CmaxSS for Gr Proteinuria for Exposure-Response Analyses.||||0.484
91700127|NCT04322539|183295122|OTHER|||||||0.642|||||||Wald test|||CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.||||0.642
91700128|NCT04322539|183295122|OTHER|||||||0.166|||||||Wald test|||CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.||||0.166
91700129|NCT02111746|183295128|SUPERIORITY|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||||||0.934
91700130|NCT02111746|183295129|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
91700131|NCT02111746|183295130|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91700132|NCT02111746|183295131|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
91700133|NCT02111746|183295132|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
91700134|NCT02111746|183295133|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91700135|NCT02111746|183295134|SUPERIORITY|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
91700136|NCT02111746|183295135|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
91700137|NCT02111746|183295136|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
91700138|NCT01702532|183295154|SUPERIORITY_OR_OTHER||LS Means Difference|-4.9||||0.0141|TWO_SIDED|95.0|-8.8|-0.99||The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.|ANCOVA|ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed|Comment: The confidence interval is for the difference between treatments groups|Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.||-0.99|-8.80|0.0141
91700139|NCT03617861|183295156|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.12
91700140|NCT03617861|183295156|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.65
91700141|NCT03617861|183295156|SUPERIORITY|||||||0.0574|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.0574
91700142|NCT03617861|183295157|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
91700143|NCT03617861|183295157|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.82
91700144|NCT03617861|183295157|SUPERIORITY|||||||0.1451|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.1451
91700145|NCT03617861|183295158|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
91700146|NCT03617861|183295158|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
91700147|NCT03617861|183295158|SUPERIORITY|||||||0.4233|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.4233
91700148|NCT03617861|183295159|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.92
91700149|NCT03617861|183295159|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
91700150|NCT03617861|183295159|SUPERIORITY|||||||0.3891|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.3891
91700151|NCT03617861|183295160|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Healthy Secretin vs Healthy Placebo||||0.004
91700152|NCT03617861|183295160|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.03
91700153|NCT03617861|183295160|SUPERIORITY|||||||0.0355|||||||ANCOVA|||Healthy vs Functional Dyspepsia||||0.0355
91700154|NCT03617861|183295161|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Nausea: Healthy Controls Secretin vs Healthy Controls Placebo||||0.5
91700155|NCT03617861|183295161|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.16
91700156|NCT03617861|183295161|SUPERIORITY|||||||0.0016|||||||ANCOVA|||Nausea: Healthy Controls vs Functional Dyspepsia||||0.0016
91700157|NCT03617861|183295161|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Fullness: Healthy Controls Secretin vs Healthy Controls Placebo||||0.10
91700158|NCT03617861|183295161|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.30
91700159|NCT03617861|183295161|SUPERIORITY|||||||0.0002|||||||ANCOVA|||Fullness: Healthy Controls vs Functional Dyspepsia||||0.0002
91700160|NCT03617861|183295161|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Bloating: Healthy Controls Secretin vs Healthy Controls Placebo||||0.41
91731357|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia.||||0.0001
91731358|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes?||||||0.4754|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes.||||0.4754
91731359|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age?||||||0.1082|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age.||||0.1082
91731360|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age?||||||0.0179|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age.||||0.0179
91700161|NCT03617861|183295161|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.67
91731361|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age?||||||0.5722|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age.||||0.5722
91731362|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age?||||||0.6148|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age.||||0.6148
91731363|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age?||||||0.5307|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age.||||0.5307
91493217|NCT03095066|182857759|SUPERIORITY||Difference in LS Mean|-1.3||||0.267|TWO_SIDED|95.0|-3.5|1.0||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Baseline to Week 6: Treatment differences in each stage were estimated by the MMRM.||1.0|-3.5|0.267
91528615|NCT00874432|182932978|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||This p-value compares the baseline CBPWV measures for the CKD vs Controls group||||0.685
91731364|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during urination?||||||0.1546|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during urination.||||0.1546
91731365|NCT02732145|183357801|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active?||||||0.1019|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active.||||0.1019
91731366|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of problems associated with urination and defecation between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of problems associated with urination and defecation between patients from different groups.||||0.0000
91731367|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of dysuria between patients from different groups.||||0.0000
91731368|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent dysuria between patients from different groups.||||0.0000
91731369|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent dysuria between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent dysuria between patients from different groups.||||0.0003
91731370|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of urinary incontinence between patients from different groups?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of urinary incontinence between patients from different groups.||||0.0010
91731371|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urinary incontinence between patients from different groups?||||||0.1859|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urinary incontinence between patients from different groups.||||0.1859
91731372|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urinary incontinence between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urinary incontinence between patients from different groups.||||0.0003
91700162|NCT03617861|183295161|SUPERIORITY|||||||0.033|||||||ANCOVA|||Bloating: Healthy Controls vs Functional Dyspepsia||||0.0330
91528616|NCT00874432|182932978|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.869
91528617|NCT00874432|182932978|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||This p-value compares the baseline CRPWV measures for the CKD vs Controls group||||0.709
91700163|NCT03617861|183295161|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo||||0.25
91731373|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of difficulties at starting urination between patients from different groups?||||||0.0015|||||||Chi-squared|||Parameter: The difference in the incidence of difficulties at starting urination between patients from different groups.||||0.0015
91731374|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent difficulties at starting urination between patients from different groups?||||||0.0013|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent difficulties at starting urination between patients from different groups.||||0.0013
91731375|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent difficulties at starting urination between patients from different groups?||||||0.5673|||||||Chi-squared|||Parameter: The difference in the incidence of frequent difficulties at starting urination between patients from different groups.||||0.5673
91731376|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of urgency between patients from different groups?||||||0.0065|||||||Chi-squared|||Parameter: The difference in the incidence of urgency between patients from different groups.||||0.0065
91731377|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urgency between patients from different groups?||||||0.083|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urgency between patients from different groups.||||0.0830
91493218|NCT03095066|182857759|SUPERIORITY||Difference in LS Mean|-1.6||||0.609|TWO_SIDED|95.0|-8.0|4.8||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Week 7 to Week 12: Treatment differences in each stage were estimated by the MMRM.||4.8|-8.0|0.609
91731378|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urgency between patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urgency between patients from different groups.||||0.0001
91731379|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of nocturia between patients from different groups.||||0.0000
91731380|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent nocturia between patients from different groups?||||||0.2315|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent nocturia between patients from different groups.||||0.2315
91731381|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of frequent nocturia between patients from different groups.||||0.0000
91731382|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent cystitis between patients from different groups?||||||0.0539|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent cystitis between patients from different groups.||||0.0539
91731383|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of constipation between patients from different groups?||||||0.0379|||||||Chi-squared|||Parameter: The difference in the incidence of constipation between patients from different groups.||||0.0379
91731384|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent constipation between patients from different groups?||||||0.1485|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent constipation between patients from different groups.||||0.1485
91731385|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent constipation between patients from different groups?||||||0.4155|||||||Chi-squared|||Parameter: The difference in the incidence of frequent constipation between patients from different groups.||||0.4155
91731386|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of diarrhea between patients from different groups?||||||0.0092|||||||Chi-squared|||Parameter: The difference in the incidence of diarrhea between patients from different groups.||||0.0092
91731387|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent diarrhea between patients from different groups?||||||0.0192|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent diarrhea between patients from different groups.||||0.0192
91731388|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of frequent diarrhea between patients from different groups?||||||0.5253|||||||Chi-squared|||Parameter: The difference in the incidence of frequent diarrhea between patients from different groups.||||0.5253
91731389|NCT02732145|183357802|EQUIVALENCE|Question: Is there a difference in the incidence of the irritable colon between patients from different groups?||||||0.006|||||||Chi-squared|||Parameter: The difference in the incidence of the irritable colon between patients from different groups.||||0.0060
91731390|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of any associated symptom or disease among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of any associated symptom or disease among patients from different groups.||||0.0000
91731391|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of a frequent headache among patients from different groups?||||||0.3957|||||||Chi-squared|||Parameter: The difference in the incidence of a frequent headache among patients from different groups.||||0.3957
91731392|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of chronic fatigue among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of chronic fatigue among patients from different groups.||||0.0000
91528618|NCT00874432|182932978|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.340
91731393|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of lumbar pain among patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of lumbar pain among patients from different groups.||||0.0001
91731394|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of fibromyalgia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of fibromyalgia among patients from different groups.||||0.0000
91731395|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of energy loss among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of energy loss among patients from different groups.||||0.0000
91731396|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of sleep disorders among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of sleep disorders among patients from different groups.||||0.0000
91731397|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of pelvic pain among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of pelvic pain among patients from different groups.||||0.0000
91731398|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of unintended weight loss among patients from different groups?||||||0.1764|||||||Chi-squared|||Parameter: The difference in the incidence of unintended weight loss among patients from different groups.||||0.1764
91731399|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of endometriosis among patients from different groups?||||||0.3127|||||||Chi-squared|||Parameter: The difference in the incidence of endometriosis among patients from different groups.||||0.3127
91731400|NCT02732145|183357803|EQUIVALENCE|"Question: Is there a difference in the incidence of D-D-D Triad among patients from different groups?"||||||0.0028|||||||Chi-squared|||"Parameter: The difference in the difference in the incidence of D-D-D Triad (Dysmenorrhoea-Dyspareunia-Dysuria) among patients from different groups."||||0.0028
91493219|NCT03095066|182857760|SUPERIORITY||Difference in LS Mean|-0.3||||0.743|TWO_SIDED|95.0|-2.4|1.7||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Baseline to Week 6: Treatment differences in each stage were estimated by the MMRM.||1.7|-2.4|0.743
91493220|NCT03095066|182857760|SUPERIORITY||Difference in LS Mean|1.2||||0.575|TWO_SIDED|95.0|-3.8|6.1||MMRM included fixed effects of treatment, site, visit, treatment-by-visit interaction, baseline NPI-C-3 value and baseline-by-visit interaction.|MMRM|||Week 7 to Week 12: Treatment differences in each stage were estimated by the MMRM.||6.1|-3.8|0.575
91731401|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of hypertension among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of hypertension among patients from different groups.||||0.0000
91731402|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of genital herpes among patients from different groups?||||||0.9323|||||||Chi-squared|||Parameter: The difference in the incidence of genital herpes among patients from different groups.||||0.9323
91731403|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of thyroid disease among patients from different groups?||||||0.0011|||||||Chi-squared|||Parameter: The difference in the incidence of thyroid disease among patients from different groups.||||0.0011
91731404|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of drug allergy among patients from different groups?||||||0.2756|||||||Chi-squared|||Parameter: The difference in the incidence of drug allergy among patients from different groups.||||0.2756
91731405|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent attacks of sinusitis among patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent attacks of sinusitis among patients from different groups.||||0.0105
91731406|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of HPV infection among patients from different groups, who were tested for HPV?||||||0.2128|||||||Chi-squared|||Parameter: The difference in the incidence of HPV infection among patients from different groups, who were tested for HPV.||||0.2128
91731407|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of abnormal PAP smear among patients from different groups?||||||0.0018|||||||Chi-squared|||Parameter: The difference in the incidence of abnormal PAP smear among patients from different groups.||||0.0018
91731408|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of genital warts among patients from different groups?||||||0.2524|||||||Chi-squared|||Parameter: The difference in the incidence of genital warts among patients from different groups.||||0.2524
91731409|NCT02732145|183357803|EQUIVALENCE|Question: Is there a difference in the incidence of conization or LETZ among patients from different groups?||||||0.2452|||||||Chi-squared|||Parameter: The difference in the incidence of conization or LETZ among patients from different groups.||||0.2452
91731410|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia?||||||0.1583|||||||Chi-squared|||Parameter: The difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia.||||0.1583
91731411|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.038|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.0380
91731412|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.6468
91731413|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.467|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.4670
91493221|NCT03095066|182857761|SUPERIORITY||Difference in LS Mean|-0.1||||0.664|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Baseline to Week 6||0.3|-0.5|0.664
91493222|NCT03095066|182857761|SUPERIORITY||Difference in LS Mean|-0.6||||0.273|TWO_SIDED|95.0|-1.9|0.6|||ANCOVA|||Week 7 to Week 12||0.6|-1.9|0.273
91493223|NCT03095066|182857762|SUPERIORITY||Difference in LS Mean|-0.4||||0.159|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||Baseline to Week 6||0.1|-0.9|0.159
91493224|NCT03095066|182857762|SUPERIORITY||Difference in LS Mean|-0.2||||0.745|TWO_SIDED|95.0|-1.5|1.1|||ANCOVA|||Week 7 to Week 12||1.1|-1.5|0.745
91493225|NCT03095066|182857763|SUPERIORITY||Difference in LS Mean|-0.2||||0.268|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Baseline to Week 6||0.2|-0.5|0.268
91700164|NCT03617861|183295161|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.57
91700165|NCT03617861|183295161|SUPERIORITY|||||||0.2375|||||||ANCOVA|||Abdominal Pain: Healthy Controls vs Functional Dyspepsia||||0.2375
91731414|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.2131|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.2131
91731415|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with corticosteroids between the patients with vulvar dermatosis and vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with corticoids among patients with vulvar dermatosis and vulvodynia.||||0.0000
91700166|NCT03409107|183295336|SUPERIORITY||LS Mean Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.23|1.56|||ANCOVA|One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Treatment group comparisons were based on a ANCOVA model with terms for treatment, Baseline hemoglobin, and region.|||1.56|1.23|<0.0001
91700167|NCT03409107|183295337|SUPERIORITY||Difference in Response rate|0.56|||<|0.0001|TWO_SIDED|95.0|0.49|0.63||One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \<=0 versus alternative: difference \> 0|Cochran-Mantel-Haenszel||Treatment group comparisons were based on a Cochran-Mantel-Haenszel test adjusted for treatment group and region.|||0.63|0.49|<0.0001
91493226|NCT03095066|182857763|SUPERIORITY||Difference in LS Mean|-0.5||||0.147|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|||Week 7 to Week 12||0.2|-1.2|0.147
91700168|NCT03409107|183295338|SUPERIORITY||LS Mean Difference|5.36||||0.0005|TWO_SIDED|95.0|2.17|8.56||One-sided p-value based on test of null hypothesis:(Daprodustat-Placebo) \<= 0 vs alternative: difference \> 0.|ANCOVA||Treatment group comparisons were based on ANCOVA model with terms for treatment, Baseline score, and region.|||8.56|2.17|0.0005
91731416|NCT02732145|183357804|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antidepressant between the patients with vulvar dermatosis and vulvodynia?||||||0.0962|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antidepressant among patients with vulvar dermatosis and vulvodynia.||||0.0962
91731417|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups.||||0.0000
91493227|NCT03095066|182857764|SUPERIORITY||Difference in LS Mean|-0.1||||0.655|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Baseline to Week 6||0.3|-0.5|0.655
91493228|NCT03095066|182857764|SUPERIORITY||Difference in LS Mean|-0.2||||0.734|TWO_SIDED|95.0|-1.2|0.9|||ANCOVA|||Week 7 to Week 12||0.9|-1.2|0.734
91493229|NCT02864498|182857799|SUPERIORITY|||||||0.557|||||||General Linear Model|||||||0.5570
91493230|NCT02864498|182857799|SUPERIORITY|||||||0.8774|||||||General Linear Model|||||||0.8774
91528619|NCT00874432|182932978|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||This p-value compares the baseline CFPWV measures for the CKD vs Controls group||||0.730
91493231|NCT00730132|182857806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Pearson Chi-Square|||Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.||||0.007
91493232|NCT00730132|182857807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Chi square, continuity corrected. Asymptotic significance.|McNemar|||Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison||||<0.001
91493233|NCT00730132|182857808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.757|STANDARD_DEVIATION|12.30606||||95.0||||||||Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2||||
91493234|NCT00730132|182857808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|15.662||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
91493235|NCT00730132|182857808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.8181|STANDARD_DEVIATION|14.03545||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
91493236|NCT00730132|182857808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.80928|STANDARD_ERROR_OF_MEAN|1.48621||0.143|TWO_SIDED|95.0|-6.307|0.6884|||Games-Howell|||Statin Dose Titration compared to New Statin||.6884|-6.3070|.143
91493237|NCT00730132|182857808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.74811|STANDARD_ERROR_OF_MEAN|1.56351||0.001|TWO_SIDED|95.0|-9.4298|-2.0664|||Games-Howell|||Statin Dose Titration compared to Ezetimbe||-2.0664|-9.4298|.001
91528620|NCT00874432|182932978|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||This p-value compares the 12 month CFPWV measures for the CKD vs Controls group||||0.204
91528621|NCT00874432|182932978|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of ACE-I CKD and Control groups||||0.963
91528622|NCT00874432|182932978|SUPERIORITY|||||||0.991|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of ACE-I CKD and Control groups||||0.991
91731418|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups.||||0.0000
91731419|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups.||||0.0000
91731420|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups.||||0.0000
91731421|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups.||||0.0000
91731422|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups.||||0.0000
91731423|NCT02732145|183357805|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups.||||0.0000
91700169|NCT03409107|183295339|SUPERIORITY||Difference in Response rate|0.45|||<|0.0001|TWO_SIDED|95.0|0.37|0.52||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|Cochran-Mantel-Haenszel||Treatment group comparisons are based on a Cochran-Mantel-Haenszel test adjusted for treatment group, and region|||0.52|0.37|<0.0001
91700170|NCT03409107|183295340|SUPERIORITY||Difference in treatment effect|38.8|||||TWO_SIDED|95.0|25.0|54.55|||Hodges-Lehmann Estimate|Hodges-Lehmann Estimate of treatment difference has been reported.||||54.55|25.00|
91731424|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva?||||||0.0009|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva.||||0.0009
91731425|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva?||||||0.0289|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva.||||0.0289
91700171|NCT03409107|183295341|SUPERIORITY||Difference in treatment effect|0.768|||<|0.0001|TWO_SIDED|95.0|0.729|0.806||One-sided superiority p-value from the van Elteren test|van Elteren test||Mann-Whitney estimate of the treatment difference stratified by region has been presented.|||0.806|0.729|<0.0001
91700172|NCT03409107|183295342|SUPERIORITY||LS Mean difference|1.36|||<|0.0001|TWO_SIDED|95.0|1.16|1.55||One-sided superiority p-value from the MMRM model|MMRM||Treatment group comparisons were based on MMRM fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline Hb and Baseline Hb by time and treatment by time interactions.|||1.55|1.16|<0.0001
91700173|NCT03409107|183295343|SUPERIORITY||Hazard Ratio (HR)|0.07||||0.0002|TWO_SIDED|95.0|0.02|0.3||One-sided p-value was based on Wald test of null hypothesis: (Daprodustat/Placebo) \>=1 versus alternative: ratio\<1.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||0.30|0.02|0.0002
91528623|NCT00874432|182932978|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of ACE-I CKD and Control groups||||0.176
91731426|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis versus normal vulva?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis and normal vulva.||||0.0134
91731427|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis versus normal vulva?||||||0.0037|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis and normal vulva.||||0.0037
91731428|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva?||||||0.008|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva.||||0.0080
91528624|NCT00874432|182932978|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I CKD||||0.402
91731429|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis versus normal vulva?||||||0.0579|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis and normal vulva.||||0.0579
91493238|NCT00730132|182857808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.93883|STANDARD_ERROR_OF_MEAN|1.38286||0.086|TWO_SIDED|95.0|-6.1948|0.3171|||Games-Howell|||New Statin compared to Ezetimibe||.3171|-6.1948|.086
91700174|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|5.91|||<|0.0001|TWO_SIDED|95.0|2.83|9.0||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Tired/Low Energy/Weak domain.|||9.00|2.83|<0.0001
91731430|NCT02732145|183357805|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis versus normal vulva?||||||0.072|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis and normal vulva.||||0.0720
91700175|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|2.93||||0.0152|TWO_SIDED|95.0|0.28|5.57||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Chest Pain/Shortness of Breath Domain.|||5.57|0.28|0.0152
91700176|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|3.79||||0.0045|TWO_SIDED|95.0|0.95|6.63||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Cognitive Domain.|||6.63|0.95|0.0045
91700177|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|2.61||||0.1267|TWO_SIDED|95.0|-1.87|7.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Sleeping|||7.09|-1.87|0.1267
91700178|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|4.64||||0.0203|TWO_SIDED|95.0|0.2|9.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Standing for Long Periods of Time|||9.09|0.20|0.0203
91700179|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|2.68||||0.0266|TWO_SIDED|95.0|-0.04|5.39||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Severity of Shortness of Breath While Sitting or Resting|||5.39|-0.04|0.0266
91700180|NCT03409107|183295344|SUPERIORITY||Mean Difference (Net)|2.01||||0.0907|TWO_SIDED|95.0|-0.94|4.96||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Time with Shortness of Breath While not Doing an Activity|||4.96|-0.94|0.0907
91700181|NCT03409107|183295345|SUPERIORITY||Mean Difference (Net)|-0.13||||0.0391|TWO_SIDED|95.0|-0.28|0.02||One-sided p-value was based on test of null hypothesis: (Daprodustat-rhEPO) \>=0 versus alternative: difference \<0|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-0.28|0.0391
91700182|NCT03409107|183295346|SUPERIORITY||Mean Difference (Net)|2.57||||0.0858|TWO_SIDED|95.0|-1.12|6.26||One sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||6.26|-1.12|0.0858
91700183|NCT03409107|183295347|SUPERIORITY||Mean Difference (Net)|0.17||||0.0357|TWO_SIDED|95.0|-0.02|0.36||One sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel full of life?.|||0.36|-0.02|0.0357
91700184|NCT03409107|183295347|SUPERIORITY||Mean Difference (Net)|0.17||||0.0328|TWO_SIDED|95.0|-0.01|0.35||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you have a lot of energy?.|||0.35|-0.01|0.0328
91700185|NCT03409107|183295347|SUPERIORITY||Mean Difference (Net)|0.18||||0.0252|TWO_SIDED|95.0|0.0|0.37||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel worn out?.|||0.37|0.00|0.0252
91700186|NCT03409107|183295347|SUPERIORITY||Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.1|0.42||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel tired?.|||0.42|0.10|0.0010
91731431|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91493239|NCT00730132|182857809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.8174|STANDARD_DEVIATION|19.85205||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
91493240|NCT00730132|182857809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.2488|STANDARD_DEVIATION|20.78727||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
91731432|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731433|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731434|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731435|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731436|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731437|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731438|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of fissures the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731439|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731440|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731441|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Inner Vulvar Ring between patients within different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731442|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Middle Vulvar Ring between patients from different groups?||||||0.0632|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0632
91731443|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731444|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Middle Vulvar Ring between patients within different groups?||||||0.0043|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0043
91493241|NCT00730132|182857809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0665|STANDARD_DEVIATION|15.5901||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
91493242|NCT00730132|182857809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43138|STANDARD_ERROR_OF_MEAN|2.01009||0.756|TWO_SIDED|95.0|-6.1604|3.2977|||Games-Howell|||Statin Dose Titration compared to New Statin||3.2977|-6.1604|.756
91493243|NCT00730132|182857809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.24911|STANDARD_ERROR_OF_MEAN|1.97821||0.023|TWO_SIDED|95.0|-9.9072|-0.591|||Games-Howell|||Statin Dose Titration compared to Ezetimibe||-.5910|-9.9072|.023
91493244|NCT00730132|182857809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.81773|STANDARD_ERROR_OF_MEAN|1.88425||0.107|TWO_SIDED|95.0|-8.2523|0.6169|||Games-Howell|||New Statin compared to Ezetimibe||.6169|-8.2523|.107
91493245|NCT00370032|182857810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.131||95.0|-18.4|2.157|||paired t-test Hommel-Simes|||||2.157|-18.4|0.131
91493246|NCT00370032|182857810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.131||95.0|-21.2|2.997|||paired t-test Hommel-Simes|||||2.997|-21.2|0.131
91493247|NCT00801632|182857813|SUPERIORITY_OR_OTHER||Percentage of Participants|60.0|||||TWO_SIDED|95.0|14.7|94.7|||||Clopper-Pearson used to derive confidence interval|||94.7|14.7|
91493248|NCT00801632|182857815|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.|t-test, 2 sided|The test describes whether the average of the difference is different from zero.||||||0.215
91493249|NCT01203098|182857826|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.3|||||TWO_SIDED|95.0|-7.2|4.6||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||4.6|-7.2|
91700187|NCT03409107|183295354|SUPERIORITY||Mean Difference (Net)|0.03||||0.1098|TWO_SIDED|95.0|-0.02|0.07||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus. alternative: difference \>0.|MMRM||Based on MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.07|-0.02|0.1098
91700188|NCT03409107|183295355|SUPERIORITY||Mean Difference (Net)|4.5||||0.012|TWO_SIDED|95.0|0.6|8.4||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||8.40|0.60|0.0120
91731445|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Typ), evaluated with Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91493250|NCT01203098|182857826|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|-4.6|6.8||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||6.8|-4.6|
91493251|NCT03851705|182857835|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.9047|TWO_SIDED|95.0|-29.19|25.83||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||25.83|-29.19|0.9047
91493252|NCT03851705|182857836|SUPERIORITY||Mean Difference (Final Values)|6.47||||0.8685|TWO_SIDED|95.0|-70.11|83.05||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||83.05|-70.11|0.8685
91493253|NCT03851705|182857837|SUPERIORITY||Mean Difference (Final Values)|-12.1||||0.2347|TWO_SIDED|95.0|-32.2|8.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.1|-32.2|0.2347
91493254|NCT03851705|182857837|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.7058|TWO_SIDED|95.0|-19.9|29.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||29.2|-19.9|0.7058
91493255|NCT03851705|182857837|SUPERIORITY||Mean Difference (Final Values)|-5.7||||0.5653|TWO_SIDED|95.0|-25.5|14.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||14.1|-25.5|0.5653
91493256|NCT03851705|182857839|SUPERIORITY||Mean Difference (Final Values)|-19.9||||0.4589|TWO_SIDED|95.0|-73.3|33.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.6|-73.3|0.4589
91493257|NCT03851705|182857839|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.5956|TWO_SIDED|95.0|-48.8|84.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||84.3|-48.8|0.5956
91493258|NCT03851705|182857839|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.7861|TWO_SIDED|95.0|-62.7|47.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||47.7|-62.7|0.7861
91493259|NCT03851705|182857841|SUPERIORITY||Mean Difference (Final Values)|-62.6|||<|0.0001|TWO_SIDED|95.0|-80.1|-45.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-45.1|-80.1|<.0001
91493260|NCT03851705|182857841|SUPERIORITY||Mean Difference (Final Values)|-60.6|||<|0.0001|TWO_SIDED|95.0|-83.5|-37.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-37.8|-83.5|<.0001
91700189|NCT03409107|183295356|SUPERIORITY||Mean Difference (Net)|0.4||||0.6106|TWO_SIDED|95.0|-2.42|3.22||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline SBP and Baseline SBP by time and treatment by time interactions.|||3.22|-2.42|0.6106
91700190|NCT03409107|183295356|SUPERIORITY||Mean Difference (Net)|1.8||||0.9819|TWO_SIDED|95.0|0.12|3.49||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \< 0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline DBP and Baseline DBP by time and treatment by time interactions.|||3.49|0.12|0.9819
91493261|NCT03851705|182857841|SUPERIORITY||Mean Difference (Final Values)|-92.3|||<|0.0001|TWO_SIDED|95.0|-120.4|-64.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-64.2|-120.4|<.0001
91493262|NCT03851705|182857843|SUPERIORITY||Mean Difference (Final Values)|-316.6|||<|0.0001|TWO_SIDED|95.0|-420.7|-212.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-212.6|-420.7|<.0001
91493263|NCT03851705|182857843|SUPERIORITY||Mean Difference (Final Values)|-304.4|||<|0.0001|TWO_SIDED|95.0|-408.0|-200.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-200.8|-408.0|<.0001
91700191|NCT03409107|183295356|SUPERIORITY||Mean Difference (Net)|1.31||||0.9215|TWO_SIDED|95.0|-0.51|3.13||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline MAP and Baseline MAP by time and treatment by time interactions.|||3.13|-0.51|0.9215
91700192|NCT03409107|183295357|SUPERIORITY||Difference in Response rate|0.06||||0.068|TWO_SIDED|95.0|-0.02|0.13||One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test was performed for treatment group comparison.|||0.13|-0.02|0.0680
91700193|NCT05174949|183295397|SUPERIORITY|We performed a linear regression analysis (generalized estimating equations) in which we compared both intervention groups to the sham group and added a time interaction term|Mean Difference (Final Values)|5.4|STANDARD_DEVIATION|3.58|<|0.0001|TWO_SIDED|95.0|2.4|8.4||Anode compared to sham: p = 0.0516 Cathode compared to sham: p \<.0001 . Anode change over time compared to sham p=0.0255 Cathode change over time compared to sham p\<.0001|Generalized Estimating Equations||Anode mean change = 4.13 std = 4.29 CLM = 0.5-7.7 Cathode mean change = 5.38 std = 3.58 CLM=2.4-8.4|We will report first anode compared to sham and then cathode compared to sham||8.4|2.4|<0.0001
91700194|NCT05174949|183295398|SUPERIORITY||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|9.5||0.002|TWO_SIDED|95.0|-32.2|-16.2||anode compared to sham p= 0.0020 cathode compared to sham p = 0.0088 anode over time anode compared to sham p \<.0001 Cathode over time compared to sham p \<.0001|Regression, Cox||anode -24.2 (-32.2, -16.2) cathode -22.2 (-30.6, -13.8)|We compared anode to sham We compared cathode to sham We compared the change over time of anode to sham We compared the change over time of cathode to shal||-16.2|-32.2|0.0020
91700195|NCT05174949|183295399|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0001|TWO_SIDED|95.0|0.0|0.1||Compare anode to sham p= 0.0001 Compare cathode to sham p=0.1073 Compare anode change in time to sham p=0.0938 Compare cathode change in time to sham 0.0068|Regression, Linear|Using generalized estimating equations with group and time component|Anode = 0.077 (0.00, 0.10) Cathode = -.0.125 (-0.32 0.07 )|e compare anode to sham We compare cathode to sham||0.10|0.00|0.0001
91700196|NCT02951533|183295400|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91700197|NCT01537068|183295474|SUPERIORITY_OR_OTHER||Test of Within-subjects effects|2.95||||0.09|TWO_SIDED||||||Mixed Models Analysis|Repeated Measures of ANOVA||||||0.09
91700198|NCT01537068|183295476|SUPERIORITY_OR_OTHER||Chi-squared|6.32||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
91759168|NCT04038567|183411370|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.0|1.39||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.39|-1.00|
91493264|NCT03851705|182857843|SUPERIORITY||Mean Difference (Final Values)|-390.4|||<|0.0001|TWO_SIDED|95.0|-504.5|-276.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||-276.3|-504.5|<.0001
91493265|NCT03851705|182857845|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.3299|TWO_SIDED|95.0|-23.9|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.2|-23.9|0.3299
91493266|NCT03851705|182857845|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.7778|TWO_SIDED|95.0|-16.7|22.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||22.2|-16.7|0.7778
91700199|NCT03724877|183295493|OTHER||Adjusted hazard ratio (HR)|1.04|||||TWO_SIDED|95.0|0.79|1.38|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted forced expiratory volume1 (FEV1).|||1.38|0.79|
91700200|NCT03724877|183295494|OTHER||Adjusted HR|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||1.09|0.87|
91700201|NCT03724877|183295495|OTHER||Adjusted HR|1.46|||||TWO_SIDED|95.0|1.03|2.07|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||2.07|1.03|
91700202|NCT03724877|183295496|OTHER||Adjusted rate ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Moderate/ sever exacerbation||1.04|0.83|
91700203|NCT03724877|183295496|OTHER||Adjusted rate ratio|0.94|||||TWO_SIDED|95.0|0.7|1.28|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Severe exacerbation||1.28|0.70|
91700204|NCT04017832|183295497|SUPERIORITY||Mean Difference (Net)|-0.2||||0.0078|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.1|-0.3|0.0078
91700205|NCT04017832|183295497|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.6||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.6|-0.8|<0.0001
91700206|NCT04017832|183295497|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.8|-1.1|< 0.0001
91700207|NCT01565369|183295543|SUPERIORITY_OR_OTHER||Fleiss' kappa|0.8547|STANDARD_ERROR_OF_MEAN|0.0282|<|0.0001||95.0||||evaluated at the .05 significance level|Fleiss' kappa|||Fleiss' kappa||||<0.0001
91700208|NCT00125242|183295561|SUPERIORITY_OR_OTHER||effect size|7.15|STANDARD_DEVIATION|3.1|||TWO_SIDED||||||||the reported effect size is a d-index value|Effect sizes were calculated - this is a comparison of perfomance in baseline (repeated measurements prior to treatment) relative to peformance following treatment||||
91700209|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|7.44||0.97|TWO_SIDED|95.0|-14.3|14.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||14.9|-14.3|0.97
91700210|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|6.15||0.58|TWO_SIDED|95.0|-8.6|15.5|||ANCOVA|||||15.5|-8.6|0.58
91700211|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|6.13||0.33|TWO_SIDED|95.0|-6.1|18.0|||ANCOVA|||||18.0|-6.1|0.33
91700212|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.6|STANDARD_ERROR_OF_MEAN|6.2||0.005|TWO_SIDED|95.0|5.4|29.8|||ANCOVA|||||29.8|5.4|0.005
91700213|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.2|STANDARD_ERROR_OF_MEAN|6.1||0.003|TWO_SIDED|95.0|6.2|30.2|||ANCOVA|||||30.2|6.2|0.003
91700214|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|7.37||0.003|TWO_SIDED|95.0|7.2|36.1|||ANCOVA|||||36.1|7.2|0.003
91700215|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.3|STANDARD_ERROR_OF_MEAN|7.32|<|0.001|TWO_SIDED|95.0|11.9|40.7|||ANCOVA|||||40.7|11.9|<0.001
91700216|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0|STANDARD_ERROR_OF_MEAN|8.46||0.2|TWO_SIDED|95.0|-5.6|27.6|||ANCOVA|||||27.6|-5.6|0.20
91700217|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.5|STANDARD_ERROR_OF_MEAN|8.43||0.015|TWO_SIDED|95.0|4.0|37.1|||ANCOVA|||||37.1|4.0|0.015
91700218|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.4|STANDARD_ERROR_OF_MEAN|8.43||0.008|TWO_SIDED|95.0|5.9|39.0|||ANCOVA|||||39.0|5.9|0.008
91700219|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.0|STANDARD_ERROR_OF_MEAN|7.32||0.003|TWO_SIDED|95.0|7.6|36.3|||ANCOVA|||||36.3|7.6|0.003
91700220|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.2|STANDARD_ERROR_OF_MEAN|8.46||0.009|TWO_SIDED|95.0|5.6|38.8|||ANCOVA|||||38.8|5.6|0.009
91700221|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|7.35|<|0.001|TWO_SIDED|95.0|11.0|39.8|||ANCOVA|||||39.8|11.0|<0.001
91700222|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|27.9|STANDARD_ERROR_OF_MEAN|7.34|<|0.001|TWO_SIDED|95.0|13.5|42.3|||ANCOVA|||||42.3|13.5|<0.001
91700223|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|39.6|STANDARD_ERROR_OF_MEAN|7.39|<|0.001|TWO_SIDED|95.0|25.1|54.1|||ANCOVA|||||54.1|25.1|<0.001
91700224|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|40.2|STANDARD_ERROR_OF_MEAN|7.31|<|0.001|TWO_SIDED|95.0|25.8|54.5|||ANCOVA|||||54.5|25.8|<0.001
91700225|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|43.6|STANDARD_ERROR_OF_MEAN|8.42|<|0.001|TWO_SIDED|95.0|27.1|60.1|||ANCOVA|||||60.1|27.1|<0.001
91700226|NCT01340027|183295643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|48.3|STANDARD_ERROR_OF_MEAN|8.35|<|0.001|TWO_SIDED|95.0|31.9|64.7|||ANCOVA|||||64.7|31.9|<0.001
91700227|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.366||0.062|TWO_SIDED|95.0|-1.4|0.03|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.03|-1.40|0.062
91700228|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.302||0.91|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA|||||0.56|-0.63|0.91
91700229|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.302||0.2|TWO_SIDED|95.0|-0.98|0.2|||ANCOVA|||||0.20|-0.98|0.20
91700230|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.96|TWO_SIDED|95.0|-0.62|0.58|||ANCOVA|||||0.58|-0.62|0.96
91700231|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||||-0.22|-1.39|0.007
91700232|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.363||0.016|TWO_SIDED|95.0|-1.59|-0.16|||ANCOVA|||||-0.16|-1.59|0.016
91700233|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.36||0.007|TWO_SIDED|95.0|-1.68|-0.27|||ANCOVA|||||-0.27|-1.68|0.007
91528625|NCT00874432|182932978|SUPERIORITY|||||||0.586|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I CKD||||0.586
91700234|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.417||0.91|TWO_SIDED|95.0|-0.87|0.77|||ANCOVA|||||0.77|-0.87|0.91
91700235|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.415||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
91493267|NCT03851705|182857845|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.6613|TWO_SIDED|95.0|-19.2|12.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||12.3|-19.2|0.6613
91493268|NCT03851705|182857846|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.4911|TWO_SIDED|95.0|-74.0|36.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||36.0|-74.0|0.4911
91493269|NCT03851705|182857846|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.7461|TWO_SIDED|95.0|-57.2|79.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||79.4|-57.2|0.7461
91493270|NCT03851705|182857846|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.837|TWO_SIDED|95.0|-62.8|51.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||51.1|-62.8|0.8370
91731446|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of papillae of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of papillae of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731447|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.0697|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.0697
91731448|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0319|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0319
91731449|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.7273|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.7273
91731450|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91731451|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91731452|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia?||||||0.2203|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.2203
91731453|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin.||||0.0000
91731454|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.0000
91731455|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0.1456|||||||t-test proportion|||Parameter: The incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.1456
91731456|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.1133|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.1133
91493271|NCT03851705|182857849|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.1371|TWO_SIDED|95.0|-29.5|4.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.2|-29.5|0.1371
91493272|NCT03851705|182857849|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.71|TWO_SIDED|95.0|-22.6|15.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||15.5|-22.6|0.7100
91493273|NCT03851705|182857849|SUPERIORITY||Mean Difference (Final Values)|-10.3||||0.2278|TWO_SIDED|95.0|-27.2|6.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||6.6|-27.2|0.2278
91493274|NCT03851705|182857851|SUPERIORITY||Mean Difference (Final Values)|-19.4||||0.2044|TWO_SIDED|95.0|-49.7|10.9||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||10.9|-49.7|0.2044
91493275|NCT03851705|182857851|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.7875|TWO_SIDED|95.0|-39.9|30.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||30.4|-39.9|0.7875
91700236|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.416||0.99|TWO_SIDED|95.0|-0.82|0.81|||ANCOVA|||||0.81|-0.82|0.99
91700237|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.361||0.77|TWO_SIDED|95.0|-0.82|0.6|||ANCOVA|||||0.60|-0.82|0.77
91700238|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.417||0.058|TWO_SIDED|95.0|-1.61|0.03|||ANCOVA|||||0.03|-1.61|0.058
91700239|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.362||0.69|TWO_SIDED|95.0|-0.85|0.57|||ANCOVA|||||0.57|-0.85|0.69
91700240|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.362||0.17|TWO_SIDED|95.0|-1.21|0.21|||ANCOVA|||||0.21|-1.21|0.17
91700241|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.364||0.73|TWO_SIDED|95.0|-0.84|0.59|||ANCOVA|||||0.59|-0.84|0.73
91700242|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.361||0.012|TWO_SIDED|95.0|-1.62|-0.2|||ANCOVA|||||-0.20|-1.62|0.012
91700243|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.414||0.018|TWO_SIDED|95.0|-1.8|-0.17|||ANCOVA|||||-0.17|-1.80|0.018
91700244|NCT01340027|183295644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.412||0.009|TWO_SIDED|95.0|-1.89|-0.28|||ANCOVA|||||-0.28|-1.89|0.009
91700245|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.46||0.51|TWO_SIDED|95.0|-1.0|0.82||Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.82|-1.00|0.51
91700246|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.355||0.21|TWO_SIDED|95.0|-0.57|0.83|||Stratified Rank ANCOVA|||||0.83|-0.57|0.21
91700247|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.361||0.89|TWO_SIDED|95.0|-0.68|0.74|||Stratified Rank ANCOVA|||||0.74|-0.68|0.89
91700248|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.365||0.001|TWO_SIDED|95.0|-1.06|0.38||P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.|Stratified Rank ANCOVA|||||0.38|-1.06|0.001
91700249|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.397||0.058|TWO_SIDED|95.0|-1.04|0.52|||Stratified Rank ANCOVA|||||0.52|-1.04|0.058
91700250|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.395||0.15|TWO_SIDED|95.0|-0.17|1.38|||Stratified Rank ANCOVA|||||1.38|-0.17|0.15
91700251|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.417||0.41|TWO_SIDED|95.0|-0.91|0.73|||Stratified Rank ANCOVA|||||0.73|-0.91|0.41
91700252|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.554||0.44|TWO_SIDED|95.0|-0.88|1.3|||Stratified Rank ANCOVA|||||1.30|-0.88|0.44
91700253|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.505||0.85|TWO_SIDED|95.0|-0.95|1.04|||Stratified Rank ANCOVA|||||1.04|-0.95|0.85
91700254|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.533||0.83|TWO_SIDED|95.0|-1.36|0.74|||Stratified Rank ANCOVA|||||0.74|-1.36|0.83
91700255|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.444||0.56|TWO_SIDED|95.0|-0.8|0.95|||Stratified Rank ANCOVA|||||0.95|-0.80|0.56
91493276|NCT03851705|182857851|SUPERIORITY||Mean Difference (Final Values)|-15.8||||0.3193|TWO_SIDED|95.0|-47.3|15.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||15.7|-47.3|0.3193
91493277|NCT03851705|182857853|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.2877|TWO_SIDED|95.0|-29.0|8.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.8|-29.0|0.2877
91700256|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.534||0.48|TWO_SIDED|95.0|-1.07|1.03|||Stratified Rank ANCOVA|||||1.03|-1.07|0.48
91700257|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.443||0.13|TWO_SIDED|95.0|-0.67|1.07|||Stratified Rank ANCOVA|||||1.07|-0.67|0.13
91493278|NCT03851705|182857853|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.7944|TWO_SIDED|95.0|-19.7|25.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||25.7|-19.7|0.7944
91493279|NCT03851705|182857853|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.5803|TWO_SIDED|95.0|-23.4|13.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.3|-23.4|0.5803
91731457|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0000
91493280|NCT03851705|182857855|SUPERIORITY||Mean Difference (Final Values)|-19.1||||0.4848|TWO_SIDED|95.0|-73.6|35.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||35.3|-73.6|0.4848
91493281|NCT03851705|182857855|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.722|TWO_SIDED|95.0|-56.0|80.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||80.3|-56.0|0.7220
91493282|NCT03851705|182857855|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.8036|TWO_SIDED|95.0|-63.6|49.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||49.5|-63.6|0.8036
91731458|NCT02732145|183357806|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0058|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0058
91493283|NCT03851705|182857863|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6028|TWO_SIDED|95.0|-6.8|11.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||11.7|-6.8|0.6028
91528626|NCT00874432|182932978|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I CKD||||0.455
91731459|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Mons pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731460|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731461|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731462|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731463|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731464|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731465|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731466|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731467|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731468|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Mons Pubis among patients from different groups?||||||0.0016|||||||Chi-squared|||"Parameter: The incidence of rhagades of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0016
91731469|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731470|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91493284|NCT03851705|182857863|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.8428|TWO_SIDED|95.0|-11.5|14.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||14.0|-11.5|0.8428
91700258|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.448||0.62|TWO_SIDED|2.0|-0.78|0.99|||Stratified Rank ANCOVA|||||0.99|-0.78|0.62
91700259|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.454||0.34|TWO_SIDED|95.0|-1.16|0.63|||Stratified Rank ANCOVA|||||0.63|-1.16|0.34
91700260|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.472||0.24|TWO_SIDED|95.0|-1.12|0.74|||Stratified Rank ANCOVA|||||0.74|-1.12|0.24
91700261|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.475||0.88|TWO_SIDED|95.0|-0.26|1.61|||Stratified Rank ANCOVA|||||1.61|-0.26|0.88
91700262|NCT01340027|183295645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.494||0.83|TWO_SIDED|95.0|-0.99|0.95|||Stratified Rank ANCOVA|||||0.95|-0.99|0.83
91700263|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.42|TWO_SIDED|95.0|0.69|2.39|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.39|0.69|0.42
91700264|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.48|TWO_SIDED|95.0|0.72|2.0|||Regression, Logistic|||||2.00|0.72|0.48
91700265|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.69|TWO_SIDED|95.0|0.67|1.83|||Regression, Logistic|||||1.83|0.67|0.69
91731471|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0014|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0014
91731472|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
91731473|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0414|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0414
91700266|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.95|TWO_SIDED|95.0|0.61|1.69|||Regression, Logistic|||||1.69|0.61|0.95
91700267|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.015|TWO_SIDED|95.0|1.14|3.21|||Regression, Logistic|||||3.21|1.14|0.015
91700268|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.023|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|||||3.84|1.11|0.023
91700269|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.16|TWO_SIDED|95.0|0.84|2.84|||Regression, Logistic|||||2.84|0.84|0.16
91700270|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|||||1.76|0.45|0.73
91700271|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||0.7|TWO_SIDED|95.0|0.45|1.72|||Regression, Logistic|||||1.72|0.45|0.70
91700272|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.74|2.99|||Regression, Logistic|||||2.99|0.74|0.26
91700273|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.63|2.04|||Regression, Logistic|||||2.04|0.63|0.69
91700274|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.29|TWO_SIDED|95.0|0.73|2.89|||Regression, Logistic|||||2.89|0.73|0.29
91700275|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.31|TWO_SIDED|95.0|0.75|2.45|||Regression, Logistic|||||2.45|0.75|0.31
91700276|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.25|||Regression, Logistic|||||2.25|0.70|0.45
91700277|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.64|TWO_SIDED|95.0|0.64|2.07|||Regression, Logistic|||||2.07|0.64|0.64
91700278|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.16||||0.013|TWO_SIDED|95.0|1.18|3.94|||Regression, Logistic|||||3.94|1.18|0.013
91700279|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.017|TWO_SIDED|95.0|1.16|4.66|||Regression, Logistic|||||4.66|1.16|0.017
91700280|NCT01340027|183295648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.74||||0.11|TWO_SIDED|95.0|0.88|3.45|||Regression, Logistic|||||3.45|0.88|0.11
91700281|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|95.0|0.16|2.56|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.56|0.16|0.52
91731474|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia?||||||0.0898|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0898
91528627|NCT00874432|182932978|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I Control Group||||0.418
91731475|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0008|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0008
91731476|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0587|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0587
91731477|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin.||||1.0000
91731478|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
91731479|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
91731480|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0002
91731481|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
91731482|NCT02732145|183357807|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0854|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0854
91731483|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731484|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731485|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91528628|NCT00874432|182932978|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I Control Group||||0.091
91528629|NCT00874432|182932978|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I Control Group||||0.034
91731486|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731487|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Anterior Commissure among patients from different groups?||||||0.0199|||||||Chi-squared|||"Parameter: The incidence of erythema of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0199
91731488|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731489|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91700282|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||0.48|TWO_SIDED|95.0|0.23|1.99|||Regression, Logistic|||||1.99|0.23|0.48
91700283|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95||||0.93|TWO_SIDED|95.0|0.32|2.81|||Regression, Logistic|||||2.81|0.32|0.93
91700284|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.12||||0.013|TWO_SIDED|95.0|1.47|25.6|||Regression, Logistic|||||25.60|1.47|0.013
91700285|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.49||||0.031|TWO_SIDED|95.0|1.17|25.77|||Regression, Logistic|||||25.77|1.17|0.031
91700286|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.84||||0.059|TWO_SIDED|95.0|0.95|15.58|||Regression, Logistic|||||15.58|0.95|0.059
91700287|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.36|TWO_SIDED|95.0|0.48|7.58|||Regression, Logistic|||||7.58|0.48|0.36
91700288|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.34||||0.26|TWO_SIDED|95.0|0.05|2.17|||Regression, Logistic|||||2.17|0.05|0.26
91700289|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43||||0.33|TWO_SIDED|95.0|0.08|2.31|||Regression, Logistic|||||2.31|0.08|0.33
91700290|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.94|TWO_SIDED|95.0|0.17|6.68|||Regression, Logistic|||||6.68|0.17|0.94
91700291|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.29|TWO_SIDED|95.0|0.09|2.02|||Regression, Logistic|||||2.02|0.09|0.29
91700292|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.15|TWO_SIDED|95.0|0.05|1.6|||Regression, Logistic|||||1.60|0.05|0.15
91700293|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.29||||0.11|TWO_SIDED|95.0|0.06|1.34|||Regression, Logistic|||||1.34|0.06|0.11
91700294|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.26|TWO_SIDED|95.0|0.09|1.89|||Regression, Logistic|||||1.89|0.09|0.26
91700295|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.67||||0.28|TWO_SIDED|95.0|0.44|16.17|||Regression, Logistic|||||16.17|0.44|0.28
91700296|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.39||||0.36|TWO_SIDED|95.0|0.37|15.46|||Regression, Logistic|||||15.46|0.37|0.36
91700297|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.56|TWO_SIDED|95.0|0.29|9.72|||Regression, Logistic|||||9.72|0.29|0.56
91700298|NCT01340027|183295650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.83||||0.84|TWO_SIDED|95.0|0.15|4.76|||Regression, Logistic|||||4.76|0.15|0.84
91700299|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61||||0.48|TWO_SIDED|95.0|0.16|2.38|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.38|0.16|0.48
91700300|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.58|TWO_SIDED|95.0|0.25|2.17|||Regression, Logistic|||||2.17|0.25|0.58
91700301|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.93|TWO_SIDED|95.0|0.34|3.28|||Regression, Logistic|||||3.28|0.34|0.93
91700302|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.16||||0.023|TWO_SIDED|95.0|1.4|105.3|||Regression, Logistic|||||105.30|1.40|0.023
91700303|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.48||||0.042|TWO_SIDED|95.0|1.08|83.24|||Regression, Logistic|||||83.24|1.08|0.042
91700304|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.03||||0.047|TWO_SIDED|95.0|1.03|79.19|||Regression, Logistic|||||79.19|1.03|0.047
91700305|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.23|TWO_SIDED|95.0|0.52|14.9|||Regression, Logistic|||||14.90|0.52|0.23
91700306|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.058|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.058
91700307|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.18||||0.15|TWO_SIDED|95.0|0.02|1.87|||Regression, Logistic|||||1.87|0.02|0.15
91700308|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.99|||Regression, Logistic|||||5.99|0.04|0.55
91700309|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.16||||0.11|TWO_SIDED|95.0|0.02|1.48|||Regression, Logistic|||||1.48|0.02|0.11
91700310|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.054|TWO_SIDED|95.0|0.01|1.05|||Regression, Logistic|||||1.05|0.01|0.054
91700311|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.12||||0.059|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.059
91700312|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.17||||0.12|TWO_SIDED|95.0|0.02|1.58|||Regression, Logistic|||||1.58|0.02|0.12
91700313|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.64|TWO_SIDED|95.0|0.11|35.46|||Regression, Logistic|||||35.46|0.11|0.64
91493285|NCT03851705|182857863|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.4946|TWO_SIDED|95.0|-6.6|13.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.4|-6.6|0.4946
91700314|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.76|TWO_SIDED|95.0|0.09|27.42|||Regression, Logistic|||||27.42|0.09|0.76
91493286|NCT03851705|182857865|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.9237|TWO_SIDED|95.0|-4.0|4.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.4|-4.0|0.9237
91528630|NCT00874432|182932978|SUPERIORITY|||||||0.921|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of the CKD and Control groups||||0.921
91528631|NCT00874432|182932978|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of the CKD and Control groups||||0.887
91700315|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.79|TWO_SIDED|95.0|0.08|26.47|||Regression, Logistic|||||26.47|0.08|0.79
91700316|NCT01340027|183295651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.77|||Regression, Logistic|||||5.77|0.04|0.55
91700317|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.495||0.25|TWO_SIDED|95.0|-1.24|0.71||All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.71|-1.24|0.25
91700318|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.383||0.35|TWO_SIDED|95.0|-0.7|0.81|||Stratified Rank ANCOVA|||||0.81|-0.70|0.35
91700319|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.371||1|TWO_SIDED|95.0|-0.74|0.72|||Stratified Rank ANCOVA|||||0.72|-0.74|1.0
91700320|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.377||0.003|TWO_SIDED|95.0|-1.08|0.41|||Stratified Rank ANCOVA|||||0.41|-1.08|0.003
91700321|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.413||0.12|TWO_SIDED|95.0|-1.04|0.59|||Stratified Rank ANCOVA|||||0.59|-1.04|0.12
91700322|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.405||0.24|TWO_SIDED|95.0|-0.21|1.38|||Stratified Rank ANCOVA|||||1.38|-0.21|0.24
91493287|NCT03851705|182857865|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7177|TWO_SIDED|95.0|-6.5|4.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||4.5|-6.5|0.7177
91493288|NCT03851705|182857865|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.5416|TWO_SIDED|95.0|-2.9|5.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.4|-2.9|0.5416
91700323|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.435||0.54|TWO_SIDED|95.0|-0.94|0.78|||Stratified Rank ANCOVA|||||0.78|-0.94|0.54
91700324|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.95|TWO_SIDED|95.0|-1.1|1.22|||Stratified Rank ANCOVA|||||1.22|-1.10|0.95
91700325|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.552||0.74|TWO_SIDED|95.0|-1.11|1.07|||Stratified Rank ANCOVA|||||1.07|-1.11|0.74
91700326|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.57||0.89|TWO_SIDED|95.0|-1.43|0.82|||Stratified Rank ANCOVA|||||0.82|-1.43|0.89
91700327|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.487||0.82|TWO_SIDED|95.0|-0.96|0.96|||Stratified Rank ANCOVA|||||0.96|-0.96|0.82
91700328|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.593||0.58|TWO_SIDED|95.0|-1.44|0.9|||Stratified Rank ANCOVA|||||0.90|-1.44|0.58
91700329|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.5||0.46|TWO_SIDED|95.0|-0.93|1.04|||Stratified Rank ANCOVA|||||1.04|-0.93|0.46
91700330|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.49||0.95|TWO_SIDED|95.0|-0.97|0.96|||Stratified Rank ANCOVA|||||0.96|-0.97|0.95
91528632|NCT00874432|182932978|SUPERIORITY|||||||0.759|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of the CKD and Control groups||||0.759
91528633|NCT00874432|182932978|SUPERIORITY|||||||0.851|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the Control groups||||0.851
91700331|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.499||0.18|TWO_SIDED|95.0|-1.32|0.65|||Stratified Rank ANCOVA|||||0.65|-1.32|0.18
91700332|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.517||0.21|TWO_SIDED|95.0|-1.24|0.8|||Stratified Rank ANCOVA|||||0.80|-1.24|0.21
91700333|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.516||0.72|TWO_SIDED|95.0|-0.43|1.6|||Stratified Rank ANCOVA|||||1.60|-0.43|0.72
91731490|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731491|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of fissures of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731492|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of fissures of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731493|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91731494|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
91700334|NCT01340027|183295652|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.541||0.92|TWO_SIDED|95.0|-1.15|0.98|||Stratified Rank ANCOVA|||||0.98|-1.15|0.92
91700335|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.412||0.002|TWO_SIDED|95.0|-2.06|-0.45|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||-0.45|-2.06|0.002
91731495|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of Labia Minora among patients from different groups?||||||0.0024|||||||Chi-squared|||"Parameter: The frequency of smoothness of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0024
91700336|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.34||0.16|TWO_SIDED|95.0|-1.15|0.19|||ANCOVA|||||0.19|-1.15|0.16
91700337|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.91|-0.57|||ANCOVA|||||-0.57|-1.91|<0.001
91700338|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.343||0.001|TWO_SIDED|95.0|-1.8|-0.46|||ANCOVA|||||-0.46|-1.80|0.001
91528634|NCT00874432|182932978|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the Control groups||||0.733
91528635|NCT00874432|182932978|SUPERIORITY|||||||0.902|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the Control groups||||0.902
91528636|NCT00874432|182932978|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the CKD ACE-I and CKD Control groups.||||0.414
91528637|NCT00874432|182932978|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the CKD ACE-I and CKD Control groups.||||0.942
91700339|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.338|<|0.001|TWO_SIDED|95.0|-2.03|-0.7|||ANCOVA|||||-0.70|-2.03|<0.001
91493289|NCT03851705|182857867|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6497|TWO_SIDED|95.0|-3.2|5.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||5.2|-3.2|0.6497
91700340|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.409||0.017|TWO_SIDED|95.0|-1.78|-0.18|||ANCOVA|||||-0.18|-1.78|0.017
91731496|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Posterior Commissure among patients from different groups?||||||0.0205|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0205
91731497|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.0158|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.0158
91493290|NCT03851705|182857867|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.3209|TWO_SIDED|95.0|-7.9|2.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||2.6|-7.9|0.3209
91731498|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0001
91731499|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.028|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0280
91731500|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91731501|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91528638|NCT00874432|182932978|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the CKD ACE-I and CKD Control groups.||||0.990
91700341|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.405||0.004|TWO_SIDED|95.0|-1.98|-0.39|||ANCOVA|||||-0.39|-1.98|0.004
91700342|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.469||0.53|TWO_SIDED|95.0|-0.63|1.22|||ANCOVA|||||1.22|-0.63|0.53
91528639|NCT00874432|182932978|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the ACE-I Control and CKD Control groups.||||0.273
91700343|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.468||0.85|TWO_SIDED|95.0|-0.83|1.01|||ANCOVA|||||1.01|-0.83|0.85
91700344|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.468||0.84|TWO_SIDED|95.0|-1.01|0.83|||ANCOVA|||||0.83|-1.01|0.84
91700345|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.406||0.05|TWO_SIDED|95.0|0.0|1.59|||ANCOVA|||||1.59|-0.00|0.050
91493291|NCT03851705|182857867|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9294|TWO_SIDED|95.0|-6.3|5.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.7|-6.3|0.9294
91493292|NCT03851705|182857869|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.3105|TWO_SIDED|95.0|-10.8|33.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.4|-10.8|0.3105
91493293|NCT03851705|182857869|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.3018|TWO_SIDED|95.0|-33.3|10.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||10.5|-33.3|0.3018
91528640|NCT00874432|182932978|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the ACE-I Control and CKD Control groups.||||0.516
91493294|NCT03851705|182857869|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8755|TWO_SIDED|95.0|-27.0|31.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||31.6|-27.0|0.8755
91493295|NCT03851705|182857871|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6848|TWO_SIDED|95.0|-11.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||7.6|-11.5|0.6848
91493296|NCT03851705|182857871|SUPERIORITY||Mean Difference (Final Values)|-5.4||||0.4075|TWO_SIDED|95.0|-18.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.6|-18.5|0.4075
91700346|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.469||0.33|TWO_SIDED|95.0|-1.38|0.46|||ANCOVA|||||0.46|-1.38|0.33
91493297|NCT03851705|182857871|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.5998|TWO_SIDED|95.0|-13.4|7.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||7.8|-13.4|0.5998
91493298|NCT03851705|182857873|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7958|TWO_SIDED|95.0|-8.4|6.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||6.5|-8.4|0.7958
91493299|NCT03851705|182857873|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.6003|TWO_SIDED|95.0|-12.7|7.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.4|-12.7|0.6003
91700347|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.407||0.44|TWO_SIDED|95.0|-0.48|1.12|||ANCOVA|||||1.12|-0.48|0.44
91700348|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.408||0.28|TWO_SIDED|95.0|-1.24|0.36|||ANCOVA|||||0.36|-1.24|0.28
91700349|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.41||0.42|TWO_SIDED|95.0|-1.14|0.47|||ANCOVA|||||0.47|-1.14|0.42
91700350|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.406||0.16|TWO_SIDED|95.0|-1.37|0.23|||ANCOVA|||||0.23|-1.37|0.16
91700351|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.467||0.7|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||||0.73|-1.10|0.70
91700352|NCT01340027|183295653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.464||0.4|TWO_SIDED|95.0|-1.3|0.52|||ANCOVA|||||0.52|-1.30|0.40
91700353|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.079||0.062|TWO_SIDED|95.0|-0.3|0.01|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.01|-0.30|0.062
91700354|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.15|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|||||0.03|-0.22|0.15
91700355|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.065||0.007|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||||-0.05|-0.30|0.007
91700356|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.066||0.017|TWO_SIDED|95.0|-0.29|-0.03|||ANCOVA|||||-0.03|-0.29|0.017
91700357|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||ANCOVA|||||-0.10|-0.35|<0.001
91700358|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||||-0.11|-0.41|<0.001
91700359|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.077||0.07|TWO_SIDED|95.0|-0.29|0.01|||ANCOVA|||||0.01|-0.29|0.070
91700360|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.15|TWO_SIDED|95.0|-0.05|0.31|||ANCOVA|||||0.31|-0.05|0.15
91700361|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.57|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|||||0.23|-0.12|0.57
91700362|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.089||0.89|TWO_SIDED|95.0|-0.16|0.19|||ANCOVA|||||0.19|-0.16|0.89
91700363|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.077||0.086|TWO_SIDED|95.0|-0.02|0.29|||ANCOVA|||||0.29|-0.02|0.086
91700364|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.88|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||||0.16|-0.19|0.88
91700365|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.078||0.61|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA|||||0.19|-0.11|0.61
91700366|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.078||0.58|TWO_SIDED|95.0|-0.2|0.11|||ANCOVA|||||0.11|-0.20|0.58
91700367|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.76|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||||0.13|-0.18|0.76
91700368|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_DEVIATION|0.077||0.23|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||||0.06|-0.25|0.23
91700369|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.15|TWO_SIDED|95.0|-0.3|0.05|||ANCOVA|||||0.05|-0.30|0.15
91700370|NCT01340027|183295654|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.94|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||||0.17|-0.18|0.94
91700371|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.33||0.29|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.30|-0.99|0.29
91700372|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.239||0.15|TWO_SIDED|95.0|-0.12|0.82|||ANCOVA|||||0.82|-0.12|0.15
91528641|NCT00874432|182932978|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the ACE-I Control and CKD Control groups.||||0.102
91700373|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.248||0.99|TWO_SIDED|95.0|-0.48|0.49|||ANCOVA|||||0.49|-0.48|0.99
91700374|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.239||0.76|TWO_SIDED|95.0|-0.54|0.4|||ANCOVA|||||0.40|-0.54|0.76
91700375|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238||0.3|TWO_SIDED|95.0|-0.71|0.22|||ANCOVA|||||0.22|-0.71|0.30
91700376|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.262||0.43|TWO_SIDED|95.0|-0.72|0.31|||ANCOVA|||||0.31|-0.72|0.43
91700377|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.296||0.4|TWO_SIDED|95.0|-0.83|0.33|||ANCOVA|||||0.33|-0.83|0.40
91700378|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.343||0.24|TWO_SIDED|95.0|-1.08|0.27|||ANCOVA|||||0.27|-1.08|0.24
91700379|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36|||ANCOVA|||||0.36|-0.98|0.36
91700380|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.348||0.02|TWO_SIDED|95.0|-1.49|-0.13|||ANCOVA|||||-0.13|-1.49|0.020
91700381|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.293||0.011|TWO_SIDED|95.0|-1.33|-0.18|||ANCOVA|||||-0.18|-1.33|0.011
91700382|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.377||0.004|TWO_SIDED|95.0|-1.84|-0.36|||ANCOVA|||||-0.36|-1.84|0.004
91700383|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.301||0.18|TWO_SIDED|95.0|-1.0|0.19|||ANCOVA|||||0.19|-1.00|0.18
91700384|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.308||0.015|TWO_SIDED|95.0|-1.35|-0.14|||ANCOVA|||||-0.14|-1.35|0.015
91700385|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.301||0.006|TWO_SIDED|95.0|-1.41|-0.23|||ANCOVA|||||-0.23|-1.41|0.006
91700386|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.59|-0.41|||ANCOVA|||||-0.41|-1.59|<0.001
91700387|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.32||0.003|TWO_SIDED|95.0|-1.59|-0.33|||ANCOVA|||||-0.33|-1.59|0.003
91700388|NCT01340027|183295655|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.348||0.004|TWO_SIDED|95.0|-1.68|-0.31|||ANCOVA|||||-0.31|-1.68|0.004
91700389|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.177||0.15|TWO_SIDED|95.0|-0.6|0.09|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.09|-0.60|0.15
91700390|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.146||0.78|TWO_SIDED|95.0|-0.33|0.25|||ANCOVA|||||0.25|-0.33|0.78
91700391|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146||0.58|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.58
91700392|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.147||0.6|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.60
91700393|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|95.0|-0.63|-0.06|||ANCOVA|||||-0.06|-0.63|0.017
91700394|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.176||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.10|-0.60|0.16
91700395|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.175||0.13|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|||||0.08|-0.61|0.13
91700396|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.81|TWO_SIDED|95.0|-0.35|0.44|||ANCOVA|||||0.44|-0.35|0.81
91700397|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.199||0.67|TWO_SIDED|95.0|-0.48|0.31|||ANCOVA|||||0.31|-0.48|0.67
91700398|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.77|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||||0.45|-0.33|0.77
91700399|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.81||0.81|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA|||||0.38|-0.30|0.81
91700400|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.201||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
91700401|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.174||0.99|TWO_SIDED|95.0|-0.34|0.34|||ANCOVA|||||0.34|-0.34|0.99
91731502|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91731503|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91731504|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
91731505|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin.||||0.0000
91731506|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin.||||0.0006
91731507|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
91731508|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0.0003|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0003
91731509|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
91731510|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.3053|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.3053
91731511|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.7758|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.7758
91731512|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.6676|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.6676
91731513|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.4577|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.4577
91700402|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.82|TWO_SIDED|95.0|-0.38|0.3|||ANCOVA|||||0.30|-0.38|0.82
91731514|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.1681|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.1681
91731515|NCT02732145|183357808|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.8848|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.8848
91731516|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731517|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
91731518|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731519|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731520|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91700403|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.84|TWO_SIDED|95.0|-0.38|0.31|||ANCOVA|||||0.31|-0.38|0.84
91700404|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.173||0.08|TWO_SIDED|95.0|-0.64|0.04|||ANCOVA|||||0.04|-0.64|0.080
91700405|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
91700406|NCT01340027|183295656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.199||0.26|TWO_SIDED|95.0|-0.62|0.17|||ANCOVA|||||0.17|-0.62|0.26
91731521|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening among the patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731522|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91700407|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.38|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.2|-0.5|0.38
91700408|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.85|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.85
91700409|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.024|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.024
91700410|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.005
91700411|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.003
91700412|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.004
91700413|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.15|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.15
91700414|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.99|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||||0.4|-0.4|0.99
91700415|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.67|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.67
91700416|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.44
91700417|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.88|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.88
91700418|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.53|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.53
91700419|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||1|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|1.0
91700420|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.084
91700421|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||||-0.0|-0.7|0.030
91700422|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.020
91700423|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.017|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.017
91700424|NCT01340027|183295657|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.26|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.26
91700425|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.04|TWO_SIDED|95.0|1.04|4.95|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||4.95|1.04|0.040
91700426|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.73|TWO_SIDED|95.0|0.63|1.92|||Regression, Logistic|||||1.92|0.63|0.73
91700427|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82||||0.05|TWO_SIDED|95.0|1.0|3.3|||Regression, Logistic|||||3.30|1.00|0.050
91700428|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.21|TWO_SIDED|95.0|0.81|2.59|||Regression, Logistic|||||2.59|0.81|0.21
91700429|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.021|TWO_SIDED|95.0|1.11|3.66|||Regression, Logistic|||||3.66|1.11|0.021
91700430|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.19|TWO_SIDED|95.0|0.79|3.4|||Regression, Logistic|||||3.40|0.79|0.19
91700431|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.57|2.19|||Regression, Logistic|||||2.19|0.57|0.74
91700432|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.57|TWO_SIDED|95.0|0.58|2.71|||Regression, Logistic|||||2.71|0.58|0.57
91700433|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.19|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|||||3.64|0.77|0.19
91700434|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.69|TWO_SIDED|95.0|0.41|1.79|||Regression, Logistic|||||1.79|0.41|0.69
91700435|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.9|TWO_SIDED|95.0|0.55|1.99|||Regression, Logistic|||||1.99|0.55|0.90
91700436|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.048|TWO_SIDED|95.0|1.01|5.55|||Regression, Logistic|||||5.55|1.01|0.048
91700437|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.67|TWO_SIDED|95.0|0.6|2.22|||Regression, Logistic|||||2.22|0.60|0.67
91700438|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.07|TWO_SIDED|95.0|0.95|3.78|||Regression, Logistic|||||3.78|0.95|0.070
91700439|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.23|TWO_SIDED|95.0|0.77|2.98|||Regression, Logistic|||||2.98|0.77|0.23
91700440|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.034|TWO_SIDED|95.0|1.06|4.19|||Regression, Logistic|||||4.19|1.06|0.034
91528642|NCT01518946|182933012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|521.0||||0.0131|TWO_SIDED|95.0|124.2|917.7|||ANOVA|||||917.7|124.2|0.0131
91731523|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731524|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731525|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731526|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731527|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hymenal Remnants among patients from different groups?||||||0.0001|||||||Chi-squared|||"Parameter: The incidence of erythema of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0001
91731528|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Bartholin's Gland Opening among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731529|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731530|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Clitoris among patients from different groups?||||||0.0023|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0023
91731531|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731532|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Meatus among patients from different groups?||||||0.0235|||||||Chi-squared|||"Parameter: The incidence of smoothness of Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0235
91731533|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Clitoris among patients from different groups?||||||0.0021|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0021
91731534|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91731535|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Meatus among patients from different groups?||||||0.0038|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0038
91731536|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Vestibule among patients from different groups?||||||0.0019|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0019
91731537|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
91493300|NCT03851705|182857873|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5352|TWO_SIDED|95.0|-11.0|5.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.8|-11.0|0.5352
91528643|NCT03918239|182933057|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.986|1.181|||ANOVA|||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.181|0.986|
91731538|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of the Vestibule among patients from different groups?||||||0.0198|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0198
91493301|NCT03851705|182857875|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.1716|TWO_SIDED|95.0|-21.8|4.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.0|-21.8|0.1716
91493302|NCT03851705|182857875|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.1671|TWO_SIDED|95.0|-46.2|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||8.2|-46.2|0.1671
91493303|NCT03851705|182857875|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.1808|TWO_SIDED|95.0|-24.2|4.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||4.7|-24.2|0.1808
91493304|NCT03851705|182857877|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.3077|TWO_SIDED|95.0|-28.3|9.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||9.1|-28.3|0.3077
91493305|NCT03851705|182857877|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.3628|TWO_SIDED|95.0|-30.1|11.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||11.2|-30.1|0.3628
91700441|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.2|TWO_SIDED|95.0|0.76|3.84|||Regression, Logistic|||||3.84|0.76|0.20
91493306|NCT03851705|182857877|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.4669|TWO_SIDED|95.0|-23.2|10.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||10.8|-23.2|0.4669
91493307|NCT03851705|182857883|SUPERIORITY||Mean Difference (Final Values)|-4.31||||0.6814|TWO_SIDED|95.0|-24.88|16.27|||ANCOVA|||||16.27|-24.88|0.6814
91493308|NCT03851705|182857884|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.8725|TWO_SIDED|95.0|-27.7|23.51|||ANCOVA|||||23.51|-27.70|0.8725
91493309|NCT03851705|182857885|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.9425|TWO_SIDED|95.0|-22.3|20.72|||ANCOVA|||||20.72|-22.30|0.9425
91493310|NCT03851705|182857886|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.2|5.2|||Regression, Logistic|||||5.2|0.2|
91493311|NCT00621582|182857889|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||comparing results of post-treatment global assessment by patient with that of pre-treatment||||0.01
91493312|NCT03617185|182857899|SUPERIORITY||Mean Difference (Net)|-1.98||||0.15|TWO_SIDED|95.0|-4.63|0.74||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.74|-4.63|0.15
91493313|NCT03617185|182857899|SUPERIORITY||Mean Difference (Net)|-2.33||||0.08|TWO_SIDED|95.0|-4.98|0.31||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.31|-4.98|0.08
91493314|NCT03617185|182857899|SUPERIORITY||Mean Difference (Net)|-1.84||||0.15|TWO_SIDED|95.0|-4.43|0.74||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.74|-4.43|0.15
91493315|NCT03617185|182857899|SUPERIORITY||Interaction term for difference in slope|0.07||||0.67|TWO_SIDED|95.0|-0.02|0.16||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.16|-0.02|0.67
91493316|NCT03617185|182857899|SUPERIORITY||Interaction term for difference in slope|0.09||||0.77|TWO_SIDED|95.0|0.002|0.19||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.19|0.002|0.77
91700442|NCT01340027|183295658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.68|TWO_SIDED|95.0|0.55|2.49|||Regression, Logistic|||||2.49|0.55|0.68
91700443|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.64|2.12|||Regression, Logistic|||||2.12|0.64|0.62
91700444|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Logistic|||||2.17|0.82|0.25
91700445|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.11|TWO_SIDED|95.0|0.91|2.41|||Regression, Logistic|||||2.41|0.91|0.11
91700446|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.81||||0.02|TWO_SIDED|95.0|1.1|2.97|||Regression, Logistic|||||2.97|1.10|0.020
91700447|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.012|TWO_SIDED|95.0|1.15|3.05|||Regression, Logistic|||||3.05|1.15|0.012
91700448|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|||||3.10|0.95|0.072
91700449|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.77|2.44|||Regression, Logistic|||||2.44|0.77|0.29
91700450|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.94|TWO_SIDED|95.0|0.49|1.93|||Regression, Logistic|||||1.93|0.49|0.94
91700451|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.8|TWO_SIDED|95.0|0.46|1.81|||Regression, Logistic|||||1.81|0.46|0.80
91700452|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.67|TWO_SIDED|95.0|0.59|2.28|||Regression, Logistic|||||2.28|0.59|0.67
91700453|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.55|1.8|||Regression, Logistic|||||1.80|0.55|1.0
91700454|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.66|TWO_SIDED|95.0|0.59|2.31|||Regression, Logistic|||||2.31|0.59|0.66
91700455|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.35|TWO_SIDED|95.0|0.73|2.4|||Regression, Logistic|||||2.40|0.73|0.35
91700456|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.19|TWO_SIDED|95.0|0.82|2.67|||Regression, Logistic|||||2.67|0.82|0.19
91700457|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.054|TWO_SIDED|95.0|0.99|3.28|||Regression, Logistic|||||3.28|0.99|0.054
91700458|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.038|TWO_SIDED|95.0|1.04|3.38|||Regression, Logistic|||||3.38|1.04|0.038
91700459|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.12|TWO_SIDED|95.0|0.87|3.39|||Regression, Logistic|||||3.39|0.87|0.12
91700460|NCT01340027|183295659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.36|TWO_SIDED|95.0|0.7|2.67|||Regression, Logistic|||||2.67|0.70|0.36
91700461|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.32|TWO_SIDED|95.0|0.06|2.43|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.43|0.06|0.32
91700462|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.21|2.61|||Regression, Logistic|||||2.61|0.21|0.65
91700463|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.39|TWO_SIDED|95.0|0.13|2.19|||Regression, Logistic|||||2.19|0.13|0.39
91700464|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.22|TWO_SIDED|95.0|0.1|1.67|||Regression, Logistic|||||1.67|0.10|0.22
91700465|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.22||||0.082|TWO_SIDED|95.0|0.04|1.22|||Regression, Logistic|||||1.22|0.04|0.082
91700466|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.36||||0.36|TWO_SIDED|95.0|0.04|3.2|||Regression, Logistic|||||3.20|0.04|0.36
91700467|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.51|TWO_SIDED|95.0|0.42|5.71|||Regression, Logistic|||||5.71|0.42|0.51
91700468|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.19|5.36|||Regression, Logistic|||||5.36|0.19|0.99
91700469|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.96|TWO_SIDED|95.0|0.24|4.59|||Regression, Logistic|||||4.59|0.24|0.96
91700470|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.57|TWO_SIDED|95.0|0.12|3.3|||Regression, Logistic|||||3.30|0.12|0.57
91700471|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.93|TWO_SIDED|95.0|0.28|3.95|||Regression, Logistic|||||3.95|0.28|0.93
91700472|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.42||||0.37|TWO_SIDED|95.0|0.06|2.79|||Regression, Logistic|||||2.79|0.06|0.37
91700473|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.74|TWO_SIDED|95.0|0.2|3.13|||Regression, Logistic|||||3.13|0.20|0.74
91700474|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57||||0.46|TWO_SIDED|95.0|0.12|2.59|||Regression, Logistic|||||2.59|0.12|0.46
91700475|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.28|TWO_SIDED|95.0|0.1|1.96|||Regression, Logistic|||||1.96|0.10|0.28
91700476|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.23||||0.11|TWO_SIDED|95.0|0.04|1.4|||Regression, Logistic|||||1.40|0.04|0.11
91700477|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.4|TWO_SIDED|95.0|0.04|3.66|||Regression, Logistic|||||3.66|0.04|0.40
91700478|NCT01340027|183295660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.5|TWO_SIDED|95.0|0.39|6.85|||Regression, Logistic|||||6.85|0.39|0.50
91700479|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.47||0.21|TWO_SIDED|95.0|-8.0|1.7|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||1.7|-8.0|0.21
91700480|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.03||0.54|TWO_SIDED|95.0|-5.2|2.7|||ANCOVA|||||2.7|-5.2|0.54
91700481|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.03||0.016|TWO_SIDED|95.0|-8.9|-0.9|||ANCOVA|||||-0.9|-8.9|0.016
91700482|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|2.05||0.011|TWO_SIDED|95.0|-9.3|-1.2|||ANCOVA|||||-1.2|-9.3|0.011
91700483|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-10.7|-2.8|||ANCOVA|||||-2.8|-10.7|<0.001
91700484|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.43||0.005|TWO_SIDED|95.0|-11.6|-2.0|||ANCOVA|||||-2.0|-11.6|0.005
91700485|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|2.44||0.056|TWO_SIDED|95.0|-9.4|0.1|||ANCOVA|||||0.1|-9.4|0.056
91700486|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.81||0.56|TWO_SIDED|95.0|-7.1|3.9|||ANCOVA|||||3.9|-7.1|0.56
91700487|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.8||0.48|TWO_SIDED|95.0|-7.5|3.5|||ANCOVA|||||3.5|-7.5|0.48
91700488|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.13||0.13|TWO_SIDED|95.0|-9.8|1.2|||ANCOVA|||||1.2|-9.8|0.13
91700489|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.42||0.61|TWO_SIDED|95.0|-6.0|3.5|||ANCOVA|||||3.5|-6.0|0.61
91700490|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|2.81||0.12|TWO_SIDED|95.0|-9.9|1.2|||ANCOVA|||||1.2|-9.9|0.12
91700491|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.44||0.31|TWO_SIDED|95.0|-7.3|2.3|||ANCOVA|||||2.3|-7.3|0.31
91700492|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|2.44||0.012|TWO_SIDED|95.0|-10.9|-1.3|||ANCOVA|||||-1.3|-10.9|0.012
91700493|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|2.46||0.008|TWO_SIDED|95.0|-11.3|-1.7|||ANCOVA|||||-1.7|-11.3|0.008
91700494|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.44||0.001|TWO_SIDED|95.0|-12.8|-3.2|||ANCOVA|||||-3.2|-12.8|0.001
91731539|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of Hart's Line among patients from different groups?||||||0.0004|||||||Chi-squared|||"Parameter: The incidence of papillae of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0004
91759169|NCT04038567|183411371|SUPERIORITY||Mean Difference (Final Values)|0.91|||||TWO_SIDED|95.0|-0.45|2.27||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.27|-0.45|
91700495|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.78||0.004|TWO_SIDED|95.0|-13.5|-2.6|||ANCOVA|||||-2.6|-13.5|0.004
91700496|NCT01340027|183295661|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.79||0.035|TWO_SIDED|95.0|-11.4|-0.4|||ANCOVA|||||-0.4|-11.4|0.035
91700497|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.2|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||3.20|0.63|0.40
91700498|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.89|TWO_SIDED|95.0|0.55|1.97|||Regression, Logistic|||||1.97|0.55|0.89
91700499|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.57|TWO_SIDED|95.0|0.63|2.33|||Regression, Logistic|||||2.33|0.63|0.57
91700500|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.36|TWO_SIDED|95.0|0.7|2.66|||Regression, Logistic|||||2.66|0.70|0.36
91700501|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.15|TWO_SIDED|95.0|0.83|3.32|||Regression, Logistic|||||3.32|0.83|0.15
91700502|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.31|TWO_SIDED|95.0|0.67|3.59|||Regression, Logistic|||||3.59|0.67|0.31
91700503|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.81|TWO_SIDED|95.0|0.42|1.95|||Regression, Logistic|||||1.95|0.42|0.81
91700504|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||0.19|TWO_SIDED|95.0|0.75|4.08|||Regression, Logistic|||||4.08|0.75|0.19
91700505|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.59|TWO_SIDED|95.0|0.56|2.77|||Regression, Logistic|||||2.77|0.56|0.59
91700506|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.13|TWO_SIDED|95.0|0.83|4.71|||Regression, Logistic|||||4.71|0.83|0.13
91700507|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.2|TWO_SIDED|95.0|0.78|3.16|||Regression, Logistic|||||3.16|0.78|0.20
91700508|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.07|TWO_SIDED|95.0|0.94|5.34|||Regression, Logistic|||||5.34|0.94|0.070
91700509|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.17|TWO_SIDED|95.0|0.81|3.33|||Regression, Logistic|||||3.33|0.81|0.17
91759170|NCT04038567|183411371|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-1.33|1.38||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.38|-1.33|
91759171|NCT04038567|183411371|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.72|0.99||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.99|-1.72|
91731540|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of the Vestibule among patients from different groups?||||||0.0053|||||||Chi-squared|||"Parameter: The incidence of papillae of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0053
91731541|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0010
91731542|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.0010
91731543|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
91731544|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
91731545|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
91731546|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
91731547|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
91731548|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.004|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0040
91700510|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.084|TWO_SIDED|95.0|0.92|3.92|||Regression, Logistic|||||3.92|0.92|0.084
91700511|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.043|TWO_SIDED|95.0|1.02|4.48|||Regression, Logistic|||||4.48|1.02|0.043
91700512|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61||||0.013|TWO_SIDED|95.0|1.22|5.58|||Regression, Logistic|||||5.58|1.22|0.013
91700513|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.43||||0.053|TWO_SIDED|95.0|0.99|5.97|||Regression, Logistic|||||5.97|0.99|0.053
91700514|NCT01340027|183295662|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.39|TWO_SIDED|95.0|0.63|3.26|||Regression, Logistic|||||3.26|0.63|0.39
91528644|NCT03918239|182933058|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.987|1.179||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.179|0.987|
91700515|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.55||0.26|TWO_SIDED|95.0|-2.1|7.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||7.9|-2.1|0.26
91700516|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.1||0.38|TWO_SIDED|95.0|-2.3|6.0|||ANCOVA|||||6.0|-2.3|0.38
91700517|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differrence|4.8|STANDARD_ERROR_OF_MEAN|2.1||0.022|TWO_SIDED|95.0|0.7|8.9|||ANCOVA|||||8.9|0.7|0.022
91700518|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|2.12||0.01|TWO_SIDED|95.0|1.3|9.7|||ANCOVA|||||9.7|1.3|0.010
91700519|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.09||0.002|TWO_SIDED|95.0|2.3|10.5|||ANCOVA|||||10.5|2.3|0.002
91700520|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|2.52||0.008|TWO_SIDED|95.0|1.7|11.6|||ANCOVA|||||11.6|1.7|0.008
91700521|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.52||0.037|TWO_SIDED|95.0|0.3|10.2|||ANCOVA|||||10.2|0.3|0.037
91700522|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.9||0.5|TWO_SIDED|95.0|-7.7|3.7|||ANCOVA|||||3.7|-7.7|0.50
91700523|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.89||0.65|TWO_SIDED|95.0|-4.4|7.0|||ANCOVA|||||7.0|-4.4|0.65
91700524|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.88||0.25|TWO_SIDED|95.0|-2.4|8.9|||ANCOVA|||||8.9|-2.4|0.25
91700525|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.51||0.76|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|||||4.1|-5.7|0.76
91700526|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.91||0.47|TWO_SIDED|95.0|-3.6|7.8|||ANCOVA|||||7.8|-3.6|0.47
91700527|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|2.52||0.67|TWO_SIDED|95.0|-3.9|6.0|||ANCOVA|||||6.0|-3.9|0.67
91700528|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED|95.0|-0.9|9.0|||ANCOVA|||||9.0|-0.9|0.11
91700529|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.2|9.7|||ANCOVA|||||9.7|-0.2|0.062
91700530|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.52||0.025|TWO_SIDED|95.0|0.7|10.6|||ANCOVA|||||10.6|0.7|0.025
91700531|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.88||0.041|TWO_SIDED|95.0|0.2|11.5|||ANCOVA|||||11.5|0.2|0.041
91700532|NCT01340027|183295663|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.88||0.12|TWO_SIDED|95.0|-1.2|10.1|||ANCOVA|||||10.1|-1.2|0.12
91700533|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.52|2.08|||Regression, Logistic|||"All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.08|0.52|0.92
91700534|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.58|1.77|||Regression, Logistic|||||1.77|0.58|0.98
91700535|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic|||||2.23|0.70|0.45
91700536|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.24|TWO_SIDED|95.0|0.79|2.53|||Regression, Logistic|||||2.53|0.79|0.24
91700537|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.21||||0.012|TWO_SIDED|95.0|1.19|4.09|||Regression, Logistic|||||4.09|1.19|0.012
91700538|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Logistic|||||2.90|0.70|0.32
91700539|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.14|||Regression, Logistic|||||3.14|0.72|0.27
91700540|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.064|TWO_SIDED|95.0|0.24|1.04|||Regression, Logistic|||||1.04|0.24|0.064
91700541|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.57|TWO_SIDED|95.0|0.59|2.61|||Regression, Logistic|||||2.61|0.59|0.57
91700542|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.55|TWO_SIDED|95.0|0.59|2.68|||Regression, Logistic|||||2.68|0.59|0.55
91700543|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.75|TWO_SIDED|95.0|0.58|2.13|||Regression, Logistic|||||2.13|0.58|0.75
91700544|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.72|TWO_SIDED|95.0|0.53|2.49|||Regression, Logistic|||||2.49|0.53|0.72
91700545|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.58|2.15|||Regression, Logistic|||||2.15|0.58|0.74
91700546|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.34|TWO_SIDED|95.0|0.71|2.71|||Regression, Logistic|||||2.71|0.71|0.34
91700547|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.19|TWO_SIDED|95.0|0.8|3.07|||Regression, Logistic|||||3.07|0.80|0.19
91731549|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0012|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0012
91731550|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
91731551|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
91731552|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
91731553|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
91731554|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
91731555|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0131|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0131
91731556|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia?||||||0.0423|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0423
91731557|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0021|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0021
91731558|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin.||||0.0000
91731559|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin.||||0.0000
91731560|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0091|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0091
91731561|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0002
91731562|NCT02732145|183357809|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
91493317|NCT03617185|182857899|SUPERIORITY||Interaction term for difference in slope|0.07||||0.69|TWO_SIDED|95.0|-0.02|0.16||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.16|-0.02|0.69
91493318|NCT03617185|182857900|SUPERIORITY||Mean Difference (Net)|-0.98||||0.27|TWO_SIDED|95.0|-2.77|0.79||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.79|-2.77|0.27
91493319|NCT03617185|182857900|SUPERIORITY||Mean Difference (Net)|-1.09||||0.18|TWO_SIDED|95.0|-2.71|0.53||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.53|-2.71|0.18
91493320|NCT03617185|182857900|SUPERIORITY||Mean Difference (Net)|1.32||||0.21|TWO_SIDED|95.0|-0.82|3.48||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||3.48|-0.82|0.21
91493321|NCT03617185|182857900|SUPERIORITY||Interaction term for difference in slope|0.02||||0.66|TWO_SIDED|95.0|-0.05|0.09||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.09|-0.05|0.66
91528645|NCT03918239|182933059|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.157|||||TWO_SIDED|90.0|1.044|1.281||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.281|1.044|
91700548|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.45||||0.012|TWO_SIDED|95.0|1.22|4.94|||Regression, Logistic|||||4.94|1.22|0.012
91700549|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.59||||0.25|TWO_SIDED|95.0|0.72|3.47|||Regression, Logistic|||||3.47|0.72|0.25
91700550|NCT01340027|183295664|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.21|TWO_SIDED|95.0|0.74|3.75|||Regression, Logistic|||||3.75|0.74|0.21
91700551|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.376||0.63|TWO_SIDED|95.0|-0.56|0.92|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.92|-0.56|0.63
91700552|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.56|TWO_SIDED|95.0|-0.43|0.79|||ANCOVA|||||0.79|-0.43|0.56
91700553|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.14|TWO_SIDED|95.0|-0.15|1.06|||ANCOVA|||||1.06|-0.15|0.14
91700554|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.313||0.027|TWO_SIDED|95.0|0.08|1.3|||ANCOVA|||||1.30|0.08|0.027
91700555|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.13|TWO_SIDED|95.0|-0.14|1.07|||ANCOVA|||||1.07|-0.14|0.13
91700556|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.371||0.049|TWO_SIDED|95.0|0.0|1.46|||ANCOVA|||||1.46|0.00|0.049
91700557|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.368||0.011|TWO_SIDED|95.0|0.22|1.66|||ANCOVA|||||1.66|0.22|0.011
91700558|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.428||0.7|TWO_SIDED|95.0|-0.67|1.01|||ANCOVA|||||1.01|-0.67|0.70
91700559|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.423||0.084|TWO_SIDED|95.0|-0.1|1.56|||ANCOVA|||||1.56|-0.10|0.084
91700560|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.425||0.12|TWO_SIDED|95.0|-0.18|1.49|||ANCOVA|||||1.49|-0.18|0.12
91700561|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.369||0.36|TWO_SIDED|95.0|-0.39|1.06|||ANCOVA|||||1.06|-0.39|0.36
91731563|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0013|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0013
91493322|NCT03617185|182857900|SUPERIORITY||Interaction term for difference in slope|0.05||||0.25|TWO_SIDED|95.0|-0.02|0.11||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.11|-0.02|0.25
91493323|NCT03617185|182857900|SUPERIORITY||Interaction term for difference in slope|-0.06||||0.09|TWO_SIDED|95.0|-0.13|0.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.01|-0.13|0.09
91493324|NCT03617185|182857901|SUPERIORITY||Mean Difference (Net)|0.06||||0.97|TWO_SIDED|95.0|-3.72|3.85||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||3.85|-3.72|0.97
91493325|NCT03617185|182857901|SUPERIORITY||Mean Difference (Net)|-3.82||||0.03|TWO_SIDED|95.0|-7.32|-0.31||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||-0.31|-7.32|0.03
91493326|NCT03617185|182857901|SUPERIORITY||Mean Difference (Net)|-1.56||||0.38|TWO_SIDED|95.0|-5.18|2.05||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||2.05|-5.18|0.38
91493327|NCT03617185|182857902|SUPERIORITY|||||||0.62||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.62
91493328|NCT03617185|182857902|SUPERIORITY|||||||0.95||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.95
91493329|NCT03617185|182857902|SUPERIORITY|||||||0.59||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.59
91700562|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.428||0.23|TWO_SIDED|95.0|-0.32|1.36|||ANCOVA|||||1.36|-0.32|0.23
91700563|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.371||0.16|TWO_SIDED|95.0|-0.21|1.25|||ANCOVA|||||1.25|-0.21|0.16
91700564|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.371||0.032|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.032
91700565|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.373||0.006|TWO_SIDED|95.0|0.3|1.76|||ANCOVA|||||1.76|0.30|0.006
91700566|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.369||0.031|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.031
91700567|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.423||0.012|TWO_SIDED|95.0|0.24|1.9|||ANCOVA|||||1.90|0.24|0.012
91700568|NCT01340027|183295672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.421||0.002|TWO_SIDED|95.0|0.45|2.1|||ANCOVA|||||2.10|0.45|0.002
91700569|NCT03518619|183295692|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.05||||||This is a calculated p-value.|t-test, 2 sided|||||||<.05
91700570|NCT03518619|183295693|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.01||||||This is a calculated p-value.|t-test, 2 sided|||||||<.01
91700571|NCT01752634|183295722|SUPERIORITY||Odds Ratio (OR)|2.32||||0.02|TWO_SIDED|95.0|1.14|4.73|||Regression, Logistic|||||4.73|1.14|0.0200
91700572|NCT01752634|183295722|SUPERIORITY||Odds Ratio (OR)|6.52|||<|1|TWO_SIDED|95.0|3.25|13.08|||Regression, Logistic|||||13.08|3.25|<0001
91700573|NCT01752634|183295722|SUPERIORITY||Odds Ratio (OR)|6.81|||<|0.0001|TWO_SIDED|95.0|3.42|13.56|||Regression, Logistic|||||13.56|3.42|<.0001
91700574|NCT01752634|183295723|SUPERIORITY||Odds Ratio (OR)|2.07||||0.165|TWO_SIDED|95.0|0.74|5.81|||Regression, Logistic|||||5.81|0.74|0.1650
91700575|NCT01752634|183295723|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0006|TWO_SIDED|95.0|2.12|15.34|||Regression, Logistic|||||15.34|2.12|0.0006
91700576|NCT01752634|183295723|SUPERIORITY||Odds Ratio (OR)|9.48|||<|0.0001|TWO_SIDED|95.0|3.33|27.0|||Regression, Logistic|||||27.00|3.33|<.0001
91700577|NCT01752634|183295724|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6421|TWO_SIDED|95.0|0.36|5.36|||Regression, Logistic|||||5.36|0.36|0.6421
91700578|NCT01752634|183295724|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0029|TWO_SIDED|95.0|1.89|21.47|||Regression, Logistic|||||21.47|1.89|0.0029
91700579|NCT01752634|183295724|SUPERIORITY||Odds Ratio (OR)|10.74||||0.0002|TWO_SIDED|95.0|3.13|36.84|||Regression, Logistic|||||36.84|3.13|0.0002
91700580|NCT01752634|183295725|SUPERIORITY||Mean Difference (Net)|-0.16||||0.3763|TWO_SIDED|95.0|-0.53|0.2|||Mixed Models Analysis|||||0.20|-0.53|0.3763
91700581|NCT01752634|183295725|SUPERIORITY||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26|||Mixed Models Analysis|||||-0.26|-0.98|0.0008
91700582|NCT01752634|183295725|SUPERIORITY||Mean Difference (Net)|-0.65||||0.0004|TWO_SIDED|95.0|-1.02|-0.29|||Mixed Models Analysis|||||-0.29|-1.02|0.0004
91700583|NCT01752634|183295726|SUPERIORITY||Mean Difference (Net)|2.42||||0.0482|TWO_SIDED|95.0|0.02|4.83|||Mixed Models Analysis|||||4.83|0.02|0.0482
91700584|NCT01752634|183295726|SUPERIORITY||Mean Difference (Net)|4.44||||0.0003|TWO_SIDED|95.0|2.05|6.83|||Mixed Models Analysis|||||6.83|2.05|0.0003
91700585|NCT01752634|183295726|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.0001|TWO_SIDED|95.0|2.91|7.69|||Mixed Models Analysis|||||7.69|2.91|<0.0001
91700586|NCT01752634|183295727|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9195|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.9195
91700587|NCT01752634|183295727|SUPERIORITY||Mean Difference (Net)|-0.17||||0.0278|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||||-0.02|-0.32|0.0278
91700588|NCT01752634|183295727|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0013|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.10|-0.40|0.0013
91700589|NCT01752634|183295728|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0245|TWO_SIDED|95.0|1.15|7.36|||Regression, Logistic|||||7.36|1.15|0.0245
91700590|NCT01752634|183295728|SUPERIORITY||Odds Ratio (OR)|7.54|||<|0.0001|TWO_SIDED|95.0|3.11|18.25|||Regression, Logistic|||||18.25|3.11|<.0001
91731564|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0001
91493330|NCT03617185|182857903|SUPERIORITY||Mean Difference (Net)|0.3||||0.89|TWO_SIDED|95.0|-4.26|4.86||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||4.86|-4.26|0.89
91493331|NCT03617185|182857903|SUPERIORITY||Mean Difference (Net)|-0.43||||0.83|TWO_SIDED|95.0|-4.64|3.76||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||3.76|-4.64|0.83
91700591|NCT01752634|183295728|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|2.97|17.22|||Regression, Logistic|||||17.22|2.97|<.0001
91700592|NCT01752634|183295729|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3149|TWO_SIDED|95.0|0.13|1.91|||Regression, Logistic|||||1.91|0.13|0.3149
91700593|NCT01752634|183295729|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0056|TWO_SIDED|95.0|0.04|0.58|||Regression, Logistic|||||0.58|0.04|0.0056
91700594|NCT01752634|183295729|SUPERIORITY||Odds Ratio (OR)|0.14||||0.0021|TWO_SIDED|95.0|0.04|0.5|||Regression, Logistic|||||0.50|0.04|0.0021
91700595|NCT01752634|183295730|SUPERIORITY||Odds Ratio (OR)|0.58||||0.1678|TWO_SIDED|95.0|0.26|1.26|||Regression, Logistic|||||1.26|0.26|0.1678
91700596|NCT01752634|183295730|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0108|TWO_SIDED|95.0|0.17|0.79|||Regression, Logistic|||||0.79|0.17|0.0108
91700597|NCT01752634|183295730|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0025|TWO_SIDED|95.0|0.13|0.65|||Regression, Logistic|||||0.65|0.13|0.0025
91700598|NCT03339726|183295773|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.22||0.3|TWO_SIDED|95.0|-0.205|0.662||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.662|-0.205|0.300
91700599|NCT03339726|183295773|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.222||0.569|TWO_SIDED|95.0|-0.311|0.564||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.564|-0.311|0.569
91700600|NCT03339726|183295773|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.645|TWO_SIDED|95.0|-0.537|0.333||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.333|-0.537|0.645
91700601|NCT03339726|183295774|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.346|TWO_SIDED|95.0|-0.267|0.759||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.759|-0.267|0.346
91700602|NCT03339726|183295774|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.263||0.938|TWO_SIDED|95.0|-0.498|0.539||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.498|0.938
91700603|NCT03339726|183295774|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.261||0.389|TWO_SIDED|95.0|-0.741|0.289||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.289|-0.741|0.389
91700604|NCT03339726|183295775|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.23||0.607|TWO_SIDED|95.0|-0.33|0.57|||ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.33|0.607
91700605|NCT03339726|183295775|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.232||0.085|TWO_SIDED|95.0|-0.06|0.86||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.86|-0.06|0.085
91700606|NCT03339726|183295775|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.22|TWO_SIDED|95.0|-0.17|0.74||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.17|0.220
91700607|NCT03339726|183295776|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.271||0.633|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.633
91700608|NCT03339726|183295776|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.952|TWO_SIDED|95.0|-0.52|0.56||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.52|0.952
91731565|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
91731566|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0008
91700609|NCT03339726|183295776|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.272||0.678|TWO_SIDED|95.0|-0.65|0.42||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.65|0.678
91700610|NCT03339726|183295777|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.25||0.126|TWO_SIDED|95.0|-0.11|0.88||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.88|-0.11|0.126
91493332|NCT03617185|182857903|SUPERIORITY||Mean Difference (Net)|0.51||||0.82|TWO_SIDED|95.0|-4.27|5.3||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||5.3|-4.27|0.82
91700611|NCT03339726|183295777|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.253||0.27|TWO_SIDED|95.0|-0.22|0.78||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-0.22|0.270
91700612|NCT03339726|183295777|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.251||0.676|TWO_SIDED|95.0|-0.6|0.39||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.39|-0.60|0.676
91700613|NCT03339726|183295778|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.264||0.421|TWO_SIDED|95.0|-0.31|0.73||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.31|0.421
91700614|NCT03339726|183295778|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.97|TWO_SIDED|95.0|-0.54|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.54|0.970
91700615|NCT03339726|183295778|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.265||0.401|TWO_SIDED|95.0|-0.74|0.3||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.30|-0.74|0.401
91700616|NCT03339726|183295779|SUPERIORITY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.272||0.257|TWO_SIDED|95.0|-0.23|0.85||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.85|-0.23|0.257
91731567|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0251|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0251
91731568|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0006
91731569|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.0211|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0211
91731570|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.3067|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.3067
91731571|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis.||||0.0295
91731572|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0149|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0149
91731573|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
91731574|NCT02732145|183357809|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0295
91731575|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening between patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening between patients from different groups, with positive AWR.||||0.0000
91731576|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of coarse AWR between patients from different groups and positive AWR?||||||0.0071|||||||Chi-squared|||Parameter: The difference in the incidence of coarse AWR between patients from different groups and positive AWR.||||0.0071
91731577|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of slow AWR between patients from different groups and positive AWR?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of slow AWR occurrence between patients from different groups and positive AWR.||||0.0010
91731578|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of provoked erythema among patients from different groups and positive AWR?||||||0.0036|||||||Chi-squared|||Parameter: The difference in the incidence of provoked erythema among patients from different groups and positive AWR.||||0.0036
91731579|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR.||||0.0032
91731580|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
91731581|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
91731582|NCT02732145|183357810|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
91731583|NCT02732145|183357810|EQUIVALENCE|"Question: Is there a difference in the incidence of Ring sign between the patients from different groups and positive AWR?"||||||0|||||||Chi-squared|||"Parameter: The difference in the incidence of Ring sign, aceto-whitening of all structures of the Inner Vulvar Ring, between the patients from different groups and positive AWR."||||0.0000
91731584|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0856|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0856
91493333|NCT03617185|182857903|SUPERIORITY||Interaction term for difference in slope|0.05||||0.51|TWO_SIDED|95.0|-0.11|0.21||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.21|-0.11|0.51
91493334|NCT03617185|182857903|SUPERIORITY||Interaction term for difference in slope|0.04||||0.6|TWO_SIDED|95.0|-0.11|0.19||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.19|-0.11|0.60
91493335|NCT03617185|182857903|SUPERIORITY||Mean Difference (Net)|0.002||||0.99|TWO_SIDED|95.0|-0.17|0.17||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.17|-0.17|0.99
91493336|NCT03617185|182857904|SUPERIORITY|||||||0.82||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.82
91493337|NCT03617185|182857904|SUPERIORITY|||||||0.21||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.21
91731585|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.4290
91731586|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0124|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0124
91731587|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
91731588|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
91731589|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.1918
91731590|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
91731591|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
91731592|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0.5822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.5822
91731593|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
91731594|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
91731595|NCT02732145|183357810|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0.4975|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.4975
91731596|NCT02732145|183357811|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients from different groups, in which the AWR was positive?||||||0.0003|||||||ANOVA|||Parameter: The difference in the velocity of the aceto-whitening occurrence (positive AWR) among patients from different groups, in which the AWR was positive.||||0.0003
91731597|NCT02732145|183357812|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups?||||||0.0004|||||||Kruskal-Wallis|||Parameter: The difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups.||||0.0004
91731598|NCT02732145|183357812|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR?||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR.||||0.0231
91731599|NCT02732145|183357812|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR?||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR.||||0.0006
91731600|NCT02732145|183357812|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR?||||||0|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR.||||0.0000
91493338|NCT03617185|182857904|SUPERIORITY|||||||0.33||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.33
91493339|NCT03617185|182857905|SUPERIORITY||Mean Difference (Net)|0.02||||0.98|TWO_SIDED|95.0|-2.12|2.17||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||2.17|-2.12|0.98
91493340|NCT03617185|182857905|SUPERIORITY||Mean Difference (Net)|-0.35||||0.71|TWO_SIDED|95.0|-2.26|1.56||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||1.56|-2.26|0.71
91700617|NCT03339726|183295779|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.275||0.877|TWO_SIDED|95.0|-0.5|0.58||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.58|-0.50|0.877
91700618|NCT03339726|183295779|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.273||0.329|TWO_SIDED|95.0|-0.8|0.27||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.80|0.329
91700619|NCT03339726|183295780|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.298||0.469|TWO_SIDED|95.0|-0.37|0.8||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.80|-0.37|0.469
91700620|NCT03339726|183295780|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.301||0.924|TWO_SIDED|95.0|-0.57|0.62||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.62|-0.57|0.924
91700621|NCT03339726|183295780|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.299||0.532|TWO_SIDED|95.0|-0.78|0.4||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.78|0.532
91700622|NCT03339726|183295781|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.309||0.579|TWO_SIDED|95.0|-0.78|0.44||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.44|-0.78|0.579
91700623|NCT03339726|183295781|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.312||0.394|TWO_SIDED|95.0|-0.88|0.35||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.35|-0.88|0.394
91700624|NCT03339726|183295781|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.31||0.76|TWO_SIDED|95.0|-0.71|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.71|0.760
91700625|NCT03339726|183295782|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.218||0.616|TWO_SIDED|95.0|-0.32|0.539||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.320|0.616
91700626|NCT03339726|183295782|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.734|TWO_SIDED|95.0|-0.359|0.508||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.508|-0.359|0.734
91700627|NCT03339726|183295782|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.218||0.874|TWO_SIDED|95.0|-0.465|0.395||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.395|-0.465|0.874
91700628|NCT03339726|183295783|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.75|TWO_SIDED|95.0|-0.53|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.53|0.750
91700629|NCT03339726|183295783|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.232||0.39|TWO_SIDED|95.0|-0.26|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.26|0.390
91700630|NCT03339726|183295783|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.236|TWO_SIDED|95.0|-0.18|0.73||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.18|0.236
91731601|NCT02732145|183357813|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR.||||0.0000
91493341|NCT03617185|182857905|SUPERIORITY||Mean Difference (Net)|0.1||||0.92|TWO_SIDED|95.0|-2.1|2.31||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||2.31|-2.10|0.92
91731602|NCT02732145|183357813|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR.||||0.0000
91700631|NCT03339726|183295784|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.267||0.707|TWO_SIDED|95.0|-0.63|0.43||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.63|0.707
91731603|NCT02732145|183357813|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR.||||0.0000
91493342|NCT03617185|182857905|SUPERIORITY||Interaction term for difference of slope|0.001||||0.98|TWO_SIDED|95.0|-0.08|0.08||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.08|-0.08|0.98
91731604|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR?||||||0.0128|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR.||||0.0128
91731605|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0000
91731606|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0.0635|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0635
91700632|NCT03339726|183295784|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.269||0.839|TWO_SIDED|95.0|-0.59|0.48||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-0.59|0.839
91731607|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR.||||0.0429
91731608|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR?||||||0.0011|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR.||||0.0011
91731609|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR?||||||0.0936|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR.||||0.0936
91493343|NCT03617185|182857905|SUPERIORITY||Interaction term for difference in slope|0.02||||0.66|TWO_SIDED|95.0|-0.06|0.1||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.10|-0.06|0.66
91700633|NCT03339726|183295784|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.267||0.864|TWO_SIDED|95.0|-0.48|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.48|0.864
91731610|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR.||||1.0000
91731611|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
91731612|NCT02732145|183357813|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
91731613|NCT02732145|183357814|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR.||||0.0000
91700634|NCT03339726|183295785|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.255||0.794|TWO_SIDED|95.0|-0.44|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.44|0.794
91700635|NCT03339726|183295785|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.257||0.628|TWO_SIDED|95.0|-0.38|0.63||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.63|-0.38|0.628
91700636|NCT03339726|183295785|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.255||0.82|TWO_SIDED|95.0|-0.45|0.56||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.45|0.820
91700637|NCT03339726|183295786|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.266||0.33|TWO_SIDED|95.0|-0.27|0.79||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.79|-0.27|0.330
91700638|NCT03339726|183295786|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.631|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.631
91700639|NCT03339726|183295786|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.625|TWO_SIDED|95.0|-0.66|0.4||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.66|0.625
91700640|NCT03339726|183295787|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.275||0.24|TWO_SIDED|95.0|-0.22|0.87||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.87|-0.22|0.240
91700641|NCT03339726|183295787|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.278||0.865|TWO_SIDED|95.0|-0.5|0.6||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.60|-0.50|0.865
91700642|NCT03339726|183295787|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.316|TWO_SIDED|95.0|-0.82|0.27||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.82|0.316
91700643|NCT03339726|183295788|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.284||0.529|TWO_SIDED|95.0|-0.38|0.74||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.38|0.529
91700644|NCT03339726|183295788|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.287||0.997|TWO_SIDED|95.0|-0.56|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.56|0.997
91700645|NCT03339726|183295788|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.285||0.532|TWO_SIDED|95.0|-0.74|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.74|0.532
91731614|NCT02732145|183357814|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR.||||0.0000
91731615|NCT02732145|183357814|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR.||||0.0000
91731616|NCT02732145|183357814|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR.||||0.0000
91700646|NCT03339726|183295789|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.309||0.468|TWO_SIDED|95.0|-0.83|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.83|0.468
91731617|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR.||||0.0318
91493344|NCT03617185|182857905|SUPERIORITY||Interaction term for difference in slope|-0.02||||0.66|TWO_SIDED|95.0|-0.1|0.06||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.06|-0.10|0.66
91493345|NCT03617185|182857906|SUPERIORITY|||||||0.26||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.26
91493346|NCT03617185|182857906|SUPERIORITY|||||||0.58||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.58
91493347|NCT03617185|182857906|SUPERIORITY|||||||0.97||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.97
91493348|NCT03617185|182857907|SUPERIORITY|||||||0.25||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.25
91493349|NCT03617185|182857907|SUPERIORITY|||||||0.98||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.98
91700647|NCT03339726|183295789|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.312||0.218|TWO_SIDED|95.0|-1.0|0.23||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.23|-1.00|0.218
91493350|NCT03617185|182857907|SUPERIORITY|||||||0.88||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.88
91493351|NCT03617185|182857908|SUPERIORITY|||||||1|TWO_SIDED|||||The P-value tests whether the change in participant count (as either having retinopathy or not having retinopathy) from baseline to 2 years differs between the treatment and no-treatment groups.|Fisher Exact|||||||1
91493352|NCT03617185|182857908|SUPERIORITY|||||||1|TWO_SIDED|||||The P-value tests whether the change in participant count (as either having retinopathy or not having retinopathy) from baseline to 2 years differs between the treatment and no-treatment groups.|Fisher Exact|||||||1
91700648|NCT03339726|183295789|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.309||0.604|TWO_SIDED|95.0|-0.77|0.45||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.45|-0.77|0.604
91493353|NCT03617185|182857908|SUPERIORITY|||||||0.44|TWO_SIDED|||||The P-value tests whether the change in participant count (as either having retinopathy or not having retinopathy) from baseline to 2 years differs between the treatment and no-treatment groups.|Fisher Exact|||||||0.44
91700649|NCT03681990|183295790|OTHER|Mixed Model ANOVA with subject as a random effect.||||||0.34||||||F test|ANOVA|||||||0.34
91700650|NCT00308750|183295796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||||||0.40
91731618|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||0.0318
91731619|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0000
91493354|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|0.05||||0.83|TWO_SIDED|95.0|-0.4|0.5||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal distal motor latency (ms)||0.50|-0.40|0.83
91493355|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|-0.2||||0.33|TWO_SIDED|95.0|-0.62|0.21||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure -Peroneal distal motor latency (ms)||0.21|-0.62|0.33
91493356|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|0.06||||0.75|TWO_SIDED|95.0|-0.36|0.49||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure -Peroneal distal motor latency (ms)||0.49|-0.36|0.75
91493357|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|-0.13||||0.45|TWO_SIDED|95.0|-0.49|0.23||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Sural peak latency (ms)||0.23|-0.49|0.45
91700651|NCT00308750|183295796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Log Rank|||||||0.19
91700652|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.96
91700653|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.15
91700654|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.92
91700655|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.97
91700656|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.71
91700657|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.66
91700658|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.93
91731620|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||1.0000
91700659|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.33
91700660|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.19
91700661|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.40
91700662|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.63
91700663|NCT00308750|183295800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.55
91700664|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.93
91700665|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.86
91700666|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.69
91700667|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.77
91700668|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.83
91700669|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.78
91700670|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||1.00
91700671|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||0.91
91700672|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.49
91700673|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.53
91700674|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.80
91700675|NCT00308750|183295801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.85
91700676|NCT00308750|183295802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87|||||||Log Rank|||||||0.87
91700677|NCT00308750|183295802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Log Rank|||||||0.05
91700678|NCT00308750|183295805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Log Rank|||||||0.71
91700679|NCT00308750|183295805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.04
91700680|NCT05007041|183295856|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-0.96||||0.0037|TWO_SIDED|95.0|-8.94|7.1|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||The null hypothesis is simultaneous vaccination with RZV and allV4 is inferior (i.e., RZV and allV4 will have a higher proportion) to RZV and HD-IIV4 with regard to the proportion of adults with at least one severe (Grade 3) solicited local or systemic reactogenicity event on days 1-8 after RZV dose||7.10|-8.94|0.0037
91493358|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|-0.24||||0.13|TWO_SIDED|95.0|-0.57|0.08||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure -Sural peak latency (ms)||0.08|-0.57|0.13
91700681|NCT05007041|183295857|OTHER|Difference in proportions|Difference in proportions|-7.77|||||TWO_SIDED|95.0|-20.22|4.69||||||||4.69|-20.22|
91700682|NCT05007041|183295858|OTHER|Difference in proportions|Difference in proportions|2.59|||||TWO_SIDED|95.0|-7.29|12.47||||||||12.47|-7.29|
91700683|NCT05007041|183295859|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|1.74||||0.0031|TWO_SIDED|95.0|-4.04|7.77||The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Difference in proportions|||Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After SHINGRIX® Dose 1 in Each Study Group||7.77|-4.04|0.0031
91700684|NCT05007041|183295860|OTHER|Difference in proportions|Difference in proportions|-6.25|||||TWO_SIDED|95.0|-13.1|0.6|||Difference in proportions|||||0.60|-13.10|
91700685|NCT05007041|183295861|OTHER|Difference in proportions|Difference in proportions|5.89|||||TWO_SIDED|95.0|-1.32|13.11|||Difference in proportions|||||13.11|-1.32|
91700686|NCT05007041|183295862|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-4.17|||<|0.0001|TWO_SIDED|95.0|-10.9|2.47|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||||2.47|-10.90|<0.0001
91700687|NCT05007041|183295863|OTHER|Difference in proportions|Difference in proportions|-5.68|||||TWO_SIDED|95.0|-17.64|6.28|||Difference in proportions|||||6.28|-17.64|
91493359|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|-0.41||||0.03|TWO_SIDED|95.0|-0.79|-0.03||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure -Sural peak latency (ms)||-0.03|-0.79|0.03
91493360|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|0.5||||0.05|TWO_SIDED|95.0|-0.002|1.01||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial distal motor latency (ms)||1.01|-0.002|0.05
91493361|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|0.48||||0.08|TWO_SIDED|95.0|-0.07|1.03||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial distal motor latency (ms)||1.03|-0.07|0.08
91493362|NCT03617185|182857909|SUPERIORITY||Mean Difference (Net)|0.21||||0.38|TWO_SIDED|95.0|-0.27|0.7||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial distal motor latency (ms)||0.70|-0.27|0.38
91493363|NCT03617185|182857910|SUPERIORITY|||||||0.48||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal amplitude (mV)||||0.48
91493364|NCT03617185|182857910|SUPERIORITY|||||||0.31||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal amplitude (mV)||||0.31
91493365|NCT03617185|182857910|SUPERIORITY|||||||0.23||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal amplitude (mV)||||0.23
91493366|NCT03617185|182857910|SUPERIORITY|||||||0.65||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial amplitude (mV)||||0.65
91493367|NCT03617185|182857910|SUPERIORITY|||||||0.69||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial amplitude (mV)||||0.69
91493368|NCT03617185|182857910|SUPERIORITY|||||||0.69||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial amplitude (mV)||||0.69
91493369|NCT03617185|182857911|SUPERIORITY|||||||0.82||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Sural amplitude (µV)||||0.82
91493370|NCT03617185|182857911|SUPERIORITY|||||||0.26||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Sural amplitude (µV)||||0.26
91493371|NCT03617185|182857911|SUPERIORITY|||||||0.62||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Sural amplitude (µV)||||0.62
91493372|NCT03617185|182857912|SUPERIORITY|||||||0.82||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal CV (m/s)||||0.82
91493373|NCT03617185|182857912|SUPERIORITY|||||||0.27||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal CV (m/s)||||0.27
91493374|NCT03617185|182857912|SUPERIORITY|||||||0.52||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal CV (m/s)||||0.52
91493375|NCT03617185|182857913|SUPERIORITY|||||||0.32||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal F wave index (ms)||||0.32
91493376|NCT03617185|182857913|SUPERIORITY|||||||0.43||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal F wave index (ms)||||0.43
91493377|NCT03617185|182857913|SUPERIORITY|||||||0.48||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Peroneal F wave index (ms)||||0.48
91493378|NCT03617185|182857913|SUPERIORITY|||||||0.75||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial F wave index (ms)||||0.75
91493379|NCT03617185|182857913|SUPERIORITY|||||||0.09||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial F wave index (ms)||||0.09
91493380|NCT03617185|182857913|SUPERIORITY|||||||0.03||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Measure - Tibial F wave index (ms)||||0.03
91493381|NCT03617185|182857914|SUPERIORITY||Mean Difference (Net)|-0.02||||0.79|TWO_SIDED|95.0|-0.16|0.129||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.129|-0.16|0.79
91493382|NCT03617185|182857914|SUPERIORITY||Mean Difference (Net)|-0.05||||0.46|TWO_SIDED|95.0|-0.2|0.01||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.01|-0.2|0.46
91700688|NCT05007041|183295864|OTHER|Difference in proportions|Difference in proportions|-3.3|||||TWO_SIDED|95.0|-10.5|3.89|||Difference in proportions|||||3.89|-10.50|
91528646|NCT01984424|182933083|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-42.31|-33.28|||Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.28|-42.31|<0.0001
91700689|NCT05007041|183295865|OTHER|Difference in proportions|Difference in proportions|-0.73|||||TWO_SIDED|95.0|-2.16|0.7|||Difference in proportions|||||0.70|-2.16|
91700690|NCT05007041|183295866|OTHER|The proportion and 95% exact binomial confidence interval between vaccine groups.|Difference in proportions|-2.88|||||TWO_SIDED|95.0|-6.36|0.6|||Difference in proportions|||||0.60|-6.36|
91700691|NCT02901275|183295900|SUPERIORITY|||||||0.61||||||No covariate or correction for multiple comparisons. a priori statistical threshold is p\<.05|Mixed Models Analysis|||||||0.61
91700692|NCT02901275|183295901|SUPERIORITY||||||<|0.0001||||||No covariates or correction for multiple comparisons. a priori threshold is p\<.05.|Mixed Models Analysis|||||||<.0001
91700693|NCT02901275|183295902|SUPERIORITY|||||||0.51||||||No covariate or correction for multiple comparisons. a priori threshold for significance is p\<.05|Mixed Models Analysis|||||||0.51
91700694|NCT01258075|183295910|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.21||0.5494|TWO_SIDED|95.0|-0.54|0.29|||ANCOVA|Based on a mixed effect ANCOVA model with treatment and previous type 2 diabetes treatment stratum as fixed effects and baseline as a covariate.||||0.29|-0.54|0.5494
91700695|NCT05870956|183295939|OTHER||Mean Difference (Net)|932.88||||0.516|TWO_SIDED|95.0|-1880.17|3745.94|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||3745.94|-1880.17|0.516
91700696|NCT05870956|183295939|OTHER||Mean Difference (Net)|4902.02||||0.02|TWO_SIDED|95.0|767.6|9036.43|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||9036.43|767.60|0.020
91700697|NCT05870956|183295939|OTHER||Mean Difference (Net)|2727.38||||0.026|TWO_SIDED|95.0|323.48|5131.27|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5131.27|323.48|0.026
91700698|NCT05870956|183295939|OTHER||Mean Difference (Net)|5462.41||||0|TWO_SIDED|95.0|2520.93|8403.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8403.90|2520.93|0.000
91700699|NCT05870956|183295940|OTHER||Mean Difference (Net)|-303.94||||0.439|TWO_SIDED|95.0|-1074.77|466.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||466.90|-1074.77|0.439
91700700|NCT05870956|183295940|OTHER||Mean Difference (Net)|2772.06||||0.021|TWO_SIDED|95.0|422.1|5122.02|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5122.02|422.10|0.021
91700701|NCT05870956|183295940|OTHER||Mean Difference (Net)|456.79||||0.328|TWO_SIDED|95.0|-458.64|1372.21|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||1372.21|-458.64|0.328
91700702|NCT05870956|183295940|OTHER||Mean Difference (Net)|620.87||||0.382|TWO_SIDED|95.0|-771.77|2013.51|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||2013.51|-771.77|0.382
91700703|NCT05870956|183295941|OTHER||Mean Difference (Net)|2.4||||0.463|TWO_SIDED|95.0|-4.0|8.9|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.9|-4.0|0.463
91700704|NCT05870956|183295941|OTHER||Mean Difference (Net)|9.6||||0.008|TWO_SIDED|95.0|2.5|16.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||16.8|2.5|0.008
91700705|NCT05870956|183295941|OTHER||Mean Difference (Net)|9.1||||0.005|TWO_SIDED|95.0|2.8|15.3|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||15.3|2.8|0.005
91700706|NCT05870956|183295941|OTHER||Mean Difference (Net)|6.4||||0.019|TWO_SIDED|95.0|1.1|11.7|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||11.7|1.1|0.019
91700707|NCT05870956|183295942|OTHER||Mean Difference (Net)|0.6||||0.801|TWO_SIDED|95.0|-4.3|5.5|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.5|-4.3|0.801
91700708|NCT05870956|183295942|OTHER||Mean Difference (Net)|8.7||||0.005|TWO_SIDED|95.0|2.7|14.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||14.8|2.7|0.005
91700709|NCT05870956|183295942|OTHER||Mean Difference (Net)|3.4||||0.17|TWO_SIDED|95.0|-1.4|8.2|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.2|-1.4|0.170
91700710|NCT05870956|183295942|OTHER||Mean Difference (Net)|1.4||||0.489|TWO_SIDED|95.0|-2.6|5.4|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.4|-2.6|0.489
91700711|NCT02091986|183295962|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.006
91493383|NCT03617185|182857914|SUPERIORITY||Mean Difference (Net)|-0.01||||0.24|TWO_SIDED|95.0|-0.26|0.07||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.07|-0.26|0.24
91493384|NCT03617185|182857914|SUPERIORITY||Interaction term for difference in slope|0.001||||0.98|TWO_SIDED|95.0|-0.01|0.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.01|-0.01|0.98
91700712|NCT02091986|183295962|SUPERIORITY_OR_OTHER|||||||0.063|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.063
91700713|NCT02091986|183295962|SUPERIORITY_OR_OTHER|||||||0.373|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.373
91700714|NCT02091986|183295963|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.001
91700715|NCT02091986|183295963|SUPERIORITY_OR_OTHER|||||||0.195|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.195
91700716|NCT02091986|183295963|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.032
91700717|NCT02091986|183295964|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||<0.001
91700718|NCT02091986|183295964|SUPERIORITY_OR_OTHER|||||||0.005|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.005
91700719|NCT02091986|183295964|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.326
91700720|NCT02091986|183295965|SUPERIORITY_OR_OTHER|||||||0.276|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.276
91700721|NCT02091986|183295965|SUPERIORITY_OR_OTHER|||||||0.759|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.759
91700722|NCT02091986|183295965|SUPERIORITY_OR_OTHER|||||||0.165|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.165
91700723|NCT02091986|183295966|SUPERIORITY_OR_OTHER|||||||0.724|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.724
91700724|NCT02091986|183295966|SUPERIORITY_OR_OTHER|||||||0.909|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.909
91493385|NCT03617185|182857914|SUPERIORITY||Interaction term for difference in slope|0.002||||0.49|TWO_SIDED|95.0|-0.004|0.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.01|-0.004|0.49
91700725|NCT02091986|183295966|SUPERIORITY_OR_OTHER|||||||0.811|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.811
91700726|NCT02091986|183295967|SUPERIORITY_OR_OTHER|||||||0.134|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.134
91700727|NCT02091986|183295967|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.985
91700728|NCT02091986|183295967|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.128
91700729|NCT02091986|183295968|SUPERIORITY_OR_OTHER|||||||0.684|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.684
91700730|NCT02091986|183295968|SUPERIORITY_OR_OTHER|||||||0.621|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.621
91700731|NCT02091986|183295968|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.929
91493386|NCT03617185|182857914|SUPERIORITY||Interaction term for difference in slope|0.004||||0.17|TWO_SIDED|95.0|-0.002|0.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.01|-0.002|0.17
91700732|NCT02091986|183295969|SUPERIORITY_OR_OTHER|||||||0.664|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.664
91700733|NCT02091986|183295969|SUPERIORITY_OR_OTHER|||||||0.747|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.747
91493387|NCT03617185|182857915|SUPERIORITY||Mean Difference (Net)|0.15||||0.07|TWO_SIDED|95.0|-0.01|0.31||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.31|-0.01|0.07
91493388|NCT03617185|182857915|SUPERIORITY||Mean Difference (Net)|0.024||||0.72|TWO_SIDED|95.0|-0.11|0.16||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.16|-0.11|0.72
91493389|NCT03617185|182857915|SUPERIORITY||Mean Difference (Net)|0.06||||0.33|TWO_SIDED|95.0|-0.06|0.19||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.19|-0.06|0.33
91700734|NCT02091986|183295969|SUPERIORITY_OR_OTHER|||||||0.913|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.913
91700735|NCT02091986|183295970|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.015
91700736|NCT02091986|183295970|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.342
91700737|NCT02091986|183295970|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.138
91700738|NCT02091986|183295974|SUPERIORITY_OR_OTHER|||||||0.098|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.098
91700739|NCT02091986|183295974|SUPERIORITY_OR_OTHER|||||||0.367|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.367
91700740|NCT02091986|183295974|SUPERIORITY_OR_OTHER|||||||0.449|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.449
91700741|NCT00606554|183295976|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
91700742|NCT00606554|183295980|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
91700743|NCT00606554|183295983|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
91700744|NCT00915876|183295984|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91700745|NCT01662791|183295990|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Comparison between the groups for \>12 ppm.||||1.0
91700746|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.235|||||||Chi-squared|||Comparison between groups for mobility sub-scale.||||0.235
91700747|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||Comparison between groups for activities of daily living sub-scale.||||0.206
91493390|NCT03617185|182857916|SUPERIORITY||Mean Difference (Net)|0.064||||0.46|TWO_SIDED|95.0|-0.11|0.24||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.24|-0.11|0.46
91493391|NCT03617185|182857916|SUPERIORITY||Mean Difference (Net)|0.13||||0.15|TWO_SIDED|95.0|-0.04|0.31||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.31|-0.04|0.15
91493392|NCT03617185|182857916|SUPERIORITY||Mean Difference (Net)|0.11||||0.2|TWO_SIDED|95.0|-0.06|0.3||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||0.30|-0.06|0.20
91493393|NCT03617185|182857917|SUPERIORITY||Wilcoxon test statistic|10.0||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment group||||0.07
91493394|NCT03617185|182857917|SUPERIORITY||Wilcoxon test statistic|3.0||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment group||||0.34
91700748|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.641|||||||Chi-squared|||Comparison between groups for emotional well-being sub-scale.||||0.641
91700749|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.446|||||||Chi-squared|||Comparison between groups for stigma sub-scale.||||0.446
91700750|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.466|||||||Chi-squared|||Comparison between groups for social support sub-scale.||||0.466
91700751|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.205|||||||Chi-squared|||Comparison between groups for cognition sub-scale.||||0.205
91700752|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.153|||||||Chi-squared|||Comparison between groups for communication sub-scale.||||0.153
91700753|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.73|||||||Chi-squared|||Comparison between groups for bodily discomfort sub-scale.||||0.730
91700754|NCT01662791|183295991|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||Comparison between groups for summary index sub-scale.||||0.334
91700755|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.167|||||||McNemar|||Comparison in case group between baseline and 3 months for mobility sub-scale.||||0.167
91700756|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.159|||||||McNemar|||Comparison in case group between baseline and 3 months for activities of daily living sub-scale.||||0.159
91700757|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.041|||||||McNemar|||Comparison in case group between baseline and 3 months for emotional well-being sub-scale.||||0.041
91700758|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.19|||||||McNemar|||Comparison in case group between baseline and 3 months for stigma sub-scale.||||0.190
91700759|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Comparison in case group between baseline and 3 months for social support sub-scale.||||1.0
91493395|NCT03617185|182857917|SUPERIORITY||Wilcoxon test statistic|2.5||||0.42|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment group||||0.42
91493396|NCT03617185|182857917|SUPERIORITY||Wilcoxon test statistic|9.0||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare within-participant change between baseline and 2 year for each treatment group||||0.77
91493397|NCT03617185|182857918|SUPERIORITY||Mean Difference (Net)|-0.61||||0.21|TWO_SIDED|95.0|-1.5|0.35||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Questionnaire||0.35|-1.5|0.21
91493398|NCT03617185|182857918|SUPERIORITY||Mean Difference (Net)|-0.09||||0.85|TWO_SIDED|95.0|-0.98|0.8||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Questionnaire||0.80|-0.98|0.85
91493399|NCT03617185|182857918|SUPERIORITY||Mean Difference (Net)|0.46||||0.37|TWO_SIDED|95.0|-0.58|1.5||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Questionnaire||1.50|-0.58|0.37
91700760|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.16|||||||McNemar|||Comparison in case group between baseline and 3 months for cognition sub-scale.||||0.160
91700761|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.276|||||||McNemar|||Comparison in case group between baseline and 3 months for communication sub-scale.||||0.276
91700762|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for bodily discomfort sub-scale.||||0.351
91700763|NCT01662791|183295992|SUPERIORITY_OR_OTHER|||||||0.186|||||||McNemar|||Comparison in case group between baseline and 3 months for summary index sub-scale.||||0.186
91700764|NCT01662791|183295993|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||Comparison between groups for constipation sub-scale.||||0.303
91700765|NCT01662791|183295993|SUPERIORITY_OR_OTHER|||||||0.518|||||||Chi-squared|||Comparison between groups for dyspepsia sub-scale.||||0.518
91700766|NCT01662791|183295993|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Comparison between groups for abdominal discomfort sub-scale.||||0.800
91700767|NCT01662791|183295993|SUPERIORITY_OR_OTHER|||||||0.736|||||||Chi-squared|||Comparison between groups for diarrhea sub-scale.||||0.736
91700768|NCT01662791|183295993|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||Comparison between groups for GERD sub-scale.||||0.570
91700769|NCT01662791|183295993|SUPERIORITY_OR_OTHER|||||||0.394|||||||Chi-squared|||Comparison between groups for nausea and vomiting sub-scale.||||0.394
91700770|NCT01662791|183295994|SUPERIORITY_OR_OTHER|||||||0.056|||||||McNemar|||Comparison in case group between baseline and 3 months for constipation sub-scale.||||0.056
91700771|NCT01662791|183295994|SUPERIORITY_OR_OTHER|||||||0.38|||||||McNemar|||Comparison in case group between baseline and 3 months for dyspepsia sub-scale.||||0.380
91700772|NCT01662791|183295994|SUPERIORITY_OR_OTHER|||||||0.244|||||||McNemar|||Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale.||||0.244
91700773|NCT01662791|183295994|SUPERIORITY_OR_OTHER|||||||0.279|||||||McNemar|||Comparison in case group between baseline and 3 months for diarrhea sub-scale.||||0.279
91700774|NCT01662791|183295994|SUPERIORITY_OR_OTHER|||||||0.554|||||||McNemar|||Comparison in case group between baseline and 3 months for GERD sub-scale.||||0.554
91700775|NCT01662791|183295994|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale.||||0.351
91700776|NCT01662791|183295995|SUPERIORITY_OR_OTHER|||||||0.872|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for depression||||0.872
91700777|NCT01662791|183295995|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for anxiety.||||0.835
91700778|NCT02496091|183296001|OTHER||95% confidence interval (using the exact|92.7|||||TWO_SIDED|95.0|88.8|95.5||||||Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.||95.5|88.8|
91493400|NCT03617185|182857918|SUPERIORITY||Interaction term for difference in slope|1.0||||0.78|TWO_SIDED|95.0|0.99|1.02||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Questionnaire||1.02|0.99|0.78
91493401|NCT03617185|182857918|SUPERIORITY||Interaction term for difference in slope|0.99||||0.53|TWO_SIDED|95.0|0.98|1.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Questionnaire||1.01|0.98|0.53
91493402|NCT03617185|182857918|SUPERIORITY||Interaction term for difference in slope|0.98||||0.08|TWO_SIDED|95.0|0.96|1.0||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Questionnaire||1.00|0.96|0.08
91493403|NCT03617185|182857919|SUPERIORITY|||||||0.01||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.01
91493404|NCT03617185|182857919|SUPERIORITY|||||||0.04||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.04
91493405|NCT03617185|182857919|SUPERIORITY|||||||0.47||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.47
91700779|NCT02272842|183296007|SUPERIORITY|The study had 80% power to detect a standardized effect size of 0.22 and had 90% power to detect an effect size of 0.28. In these calculations, we assumed a loss to follow-up of 10%. Details on the samples size calculations are also presented in the previously published protocol paper.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.35|>|0.16|TWO_SIDED|95.0|-0.54|0.87||The main analysis was the change in cognitive scores from baseline until the end of the intervention.|t-test, 2 sided||This is the P-value for the effect on the cognitive scores.|||.87|-.54|>.16
91700780|NCT02272842|183296017|SUPERIORITY|the means were compared using Students t-test|Mean Difference (Final Values)|-0.5|||>|0.3|TWO_SIDED|95.0|-1.97|0.94||"Mean difference -0.5 points in the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition.~95 % Confidence Interval of the mean difference: (-1.97, 0.94)"|t-test, 2 sided|||Comparing mean differences between the two study arms||0.94|-1.97|>.3
91700781|NCT04464720|183296025|OTHER|||||||0.05|||||||Wilcoxon Ranked Sum|||comparing pre and post intervention PM2.5||||0.050
91700782|NCT04464720|183296028|OTHER|||||||0.043|||||||Wilcoxon Ranked Sum|||comparing pre v post intervention NO2||||0.043
91700783|NCT04464720|183296031|OTHER|||||||0.056|||||||Wilcoxon Ranked Sum|||comparing FVC pre and post intervention||||0.056
91700784|NCT04464720|183296032|OTHER|||||||0.058|||||||Wilcoxon Signed Rank|||Comparing FEV1 pre and post intervention||||0.058
91700785|NCT04464720|183296034|OTHER|||||||0.058|||||||Wilcoxon Ranked Sum|||comparing FeNO pre v post intervention||||0.058
91700786|NCT02156895|183296048|OTHER||Odds Ratio (OR)|1.1||||0.1244|TWO_SIDED|95.0|0.97|1.24|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.24|0.97|0.1244
91700787|NCT02156895|183296054|OTHER||Odds Ratio (OR)|1.11||||0.0109|TWO_SIDED|95.0|1.02|1.2|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.2|1.02|0.0109
91700788|NCT03728985|183296071|NON_INFERIORITY|Performance Goal 80%|Absolute Percentage with Success|77.5||||0.5908|TWO_SIDED|90.0|69.6|84.1|||Fisher Exact||The lower estimated confidence interval above the Performance Goal of 80% would be considered success.|||84.1|69.6|0.5908
91700789|NCT03728985|183296072|NON_INFERIORITY|Performance Goal 68%|Percentage with Success|70.6||||0.7017|TWO_SIDED|90.0|61.4|78.7|||Fisher Exact|||||78.7|61.4|0.7017
91700790|NCT02417961|183296109|SUPERIORITY_OR_OTHER||Percentage|98.2||||||95.0|93.81|99.79|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)|||99.79|93.81|
91700791|NCT02417961|183296109|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)|||99.98|94.99|
91700792|NCT02417961|183296109|SUPERIORITY_OR_OTHER||Percentage|93.0|||||TWO_SIDED|95.0|86.64|96.92|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)|||96.92|86.64|
91700793|NCT02417961|183296110|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|95.21|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional APFS administered at home (Week 12)|||99.98|95.21|
91700794|NCT02417961|183296110|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional APFS administered at home (Week 16)|||99.98|94.99|
91700795|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)|||3.13|0.00|
91700796|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.9|||||TWO_SIDED|95.0|0.02|4.67|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)|||4.67|0.02|
91700797|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.16|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)|||3.16|0.00|
91700798|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)|||3.13|0.00|
91700799|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.33|||Clopper-Pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)|||3.33|0|
91700800|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.3|||||TWO_SIDED|95.0|0.01|1.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)|||1.59|0.01|
91700801|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.63|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)|||1.63|0.00|
91700802|NCT02417961|183296111|SUPERIORITY_OR_OTHER||Percentage|0.2|||||TWO_SIDED|95.0|0.0|0.97|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)|||0.97|0.00|
91700803|NCT01390428|183296116|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.73|2.01|||||Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI|Day 1||2.01|0.73|
91700804|NCT01390428|183296116|SUPERIORITY_OR_OTHER||GMR|1.66|||||TWO_SIDED|90.0|1.05|2.61|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.61|1.05|
91759172|NCT04038567|183411372|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.3|0.3||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.30|-1.30|
91700805|NCT01390428|183296116|SUPERIORITY_OR_OTHER||GMR|5.03|||||TWO_SIDED|90.0|2.19|11.56|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||11.56|2.19|
91700806|NCT01390428|183296116|SUPERIORITY_OR_OTHER||GMR|4.82|||||TWO_SIDED|90.0|2.6|8.93|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||8.93|2.60|
91700807|NCT01390428|183296116|SUPERIORITY_OR_OTHER||GMR|19.83|||||TWO_SIDED|90.0|8.11|48.51|||||Severe HI/Healthy Matched to Severe HI|Day 1||48.51|8.11|
91700808|NCT01390428|183296116|SUPERIORITY_OR_OTHER||GMR|11.68|||||TWO_SIDED|90.0|6.1|22.35|||||Severe HI/Healthy Matched to Severe HI|Day 10||22.35|6.10|
91700809|NCT01390428|183296117|SUPERIORITY_OR_OTHER||GMR|0.84|||||TWO_SIDED|90.0|0.35|2.01|||||Mild HI/Healthy Matched to Mild HI|Day 1||2.01|0.35|
91700810|NCT01390428|183296117|SUPERIORITY_OR_OTHER||GMR|1.37|||||TWO_SIDED|90.0|0.83|2.27|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.27|0.83|
91700811|NCT01390428|183296117|SUPERIORITY_OR_OTHER||GMR|7.64|||||TWO_SIDED|90.0|2.74|21.27|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||21.27|2.74|
91700812|NCT01390428|183296117|SUPERIORITY_OR_OTHER||GMR|5.98|||||TWO_SIDED|90.0|2.84|12.57|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||12.57|2.84|
91700813|NCT01390428|183296117|SUPERIORITY_OR_OTHER||GMR|15.18|||||TWO_SIDED|90.0|6.02|38.25|||||Severe HI/Healthy Matched to Severe HI|Day 1||38.25|6.02|
91700814|NCT01390428|183296117|SUPERIORITY_OR_OTHER||GMR|13.01|||||TWO_SIDED|90.0|6.0|28.21|||||Severe HI/Healthy Matched to Severe HI|Day 10||28.21|6.00|
91700815|NCT01390428|183296119|SUPERIORITY_OR_OTHER||GMR|1.86|||||TWO_SIDED|90.0|1.54|2.24|||||Mild HI/Healthy Matched to Mild HI|||2.24|1.54|
91700816|NCT01390428|183296119|SUPERIORITY_OR_OTHER||GMR|2.99|||||TWO_SIDED|90.0|1.31|6.82|||||Moderate HI/Healthy Matched to Moderate HI|||6.82|1.31|
91700817|NCT01390428|183296121|SUPERIORITY_OR_OTHER||GMR|1.92|||||TWO_SIDED|90.0|1.4|2.63|||||Mild HI/Healthy Matched to Mild HI|||2.63|1.40|
91700818|NCT01390428|183296121|SUPERIORITY_OR_OTHER||GMR|3.59|||||TWO_SIDED|90.0|1.81|7.11|||||Moderate HI/Healthy Matched to Moderate HI|||7.11|1.81|
91700819|NCT01390428|183296121|SUPERIORITY_OR_OTHER||GMR|9.34|||||TWO_SIDED|90.0|4.98|17.51|||||Severe HI/Healthy Matched to Severe HI|||17.51|4.98|
91700820|NCT05897827|183296123|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|3.93||||0.074|TWO_SIDED|95.0|3.73|4.13||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.13|3.73|0.074
91700821|NCT05897827|183296124|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 75.|Mean|75.47||||0.827|TWO_SIDED|95.0|71.12|79.83||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||79.83|71.12|0.827
91700822|NCT05897827|183296125|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.003|TWO_SIDED|95.0|3.84|4.17||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.17|3.84|0.003
91700823|NCT05897827|183296126|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.002|TWO_SIDED|95.0|3.85|4.18||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.18|3.85|0.002
91700824|NCT05897827|183296130|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.22||||0.03|TWO_SIDED|95.0|0.03|0.42||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.42|0.03|0.03
91700825|NCT05897827|183296130|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.36|0.38||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.38|-0.36|0.95
91700826|NCT05897827|183296131|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.95||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.95|0.46|<0.001
91700827|NCT05897827|183296131|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.45||||0.01|TWO_SIDED|95.0|0.1|0.8||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.80|0.10|0.01
91700828|NCT05897827|183296131|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.11|0.41||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.41|0.11|0.001
91700829|NCT05897827|183296131|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.13||||0.01|TWO_SIDED|95.0|0.03|0.24||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.24|0.03|0.01
91700830|NCT05897827|183296131|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.43||||0.001|TWO_SIDED|95.0|0.18|0.68||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.68|0.18|0.001
91493406|NCT03617185|182857919|SUPERIORITY||Interaction term for difference in slope|0.98||||0.18|TWO_SIDED|95.0|0.96|1.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||1.01|0.96|0.18
91493407|NCT03617185|182857919|SUPERIORITY||Interaction term for difference in slope|0.99||||0.52|TWO_SIDED|95.0|0.96|1.02||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||1.02|0.96|0.52
91493408|NCT03617185|182857919|SUPERIORITY||Interaction term for difference in slope|1.0||||0.87|TWO_SIDED|95.0|0.97|1.02||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||1.02|0.97|0.87
91493409|NCT03617185|182857920|SUPERIORITY|||||||0.2||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.20
91493410|NCT03617185|182857920|SUPERIORITY|||||||0.57||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.57
91493411|NCT03617185|182857920|SUPERIORITY|||||||0.61||||||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||||0.61
91493412|NCT03617185|182857921|SUPERIORITY||Mean Difference (Net)|0.73||||0.44|TWO_SIDED|-1.2|-1.2|2.67||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Total Score||2.67|-1.2|0.44
91493413|NCT03617185|182857921|SUPERIORITY||Mean Difference (Net)|-0.03||||0.97|TWO_SIDED|95.0|-2.16|2.1||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Total Score||2.10|-2.16|0.97
91493414|NCT03617185|182857921|SUPERIORITY||Mean Difference (Net)|0.4||||0.71|TWO_SIDED|95.0|-1.78|2.58||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Total Score||2.58|-1.78|0.71
91493415|NCT03617185|182857921|SUPERIORITY||Interaction term for difference in slope|1.0||||0.99|TWO_SIDED|95.0|0.98|1.02||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Total Score||1.02|0.98|0.99
91493416|NCT03617185|182857921|SUPERIORITY||Interaction term for difference in slope|1.0||||0.88|TWO_SIDED|95.0|0.98|1.02||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Total Score||1.02|0.98|0.88
91700831|NCT05897827|183296131|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44||||0.04|TWO_SIDED|95.0|0.02|0.86||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.86|0.02|0.04
91493417|NCT03617185|182857921|SUPERIORITY||Interaction term for difference in slope|0.99||||0.09|TWO_SIDED|95.0|0.97|1.0||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Total Score||1.00|0.97|0.09
91493418|NCT03617185|182857922|SUPERIORITY||Mean Difference (Net)|0.52||||0.78|TWO_SIDED|95.0|-3.41|4.45||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||4.45|-3.41|0.78
91493419|NCT03617185|182857922|SUPERIORITY||Mean Difference (Net)|-0.59||||0.63|TWO_SIDED|95.0|-3.14|1.95||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||1.95|-3.14|0.63
91493420|NCT03617185|182857922|SUPERIORITY||Mean Difference (Net)|1.01||||0.43|TWO_SIDED|95.0|-1.55|3.58||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||3.58|-1.55|0.43
91493421|NCT03617185|182857922|SUPERIORITY||Interaction term for difference in slope|0.99||||0.43|TWO_SIDED|95.0|0.98|1.01||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||1.01|0.98|0.43
91493422|NCT03617185|182857922|SUPERIORITY||Interaction term for difference in slope|1.0||||0.83|TWO_SIDED|95.0|0.98|1.02||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||1.02|0.98|0.83
91493423|NCT03617185|182857922|SUPERIORITY||Interaction term for difference in slope|0.97|||<|0.01|TWO_SIDED|95.0|0.94|0.99||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.99|0.94|<0.01
91493424|NCT03617185|182857923|SUPERIORITY||Mean Difference (Net)|-0.54||||0.84|TWO_SIDED|95.0|-6.68|5.59||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||5.59|-6.68|0.84
91493425|NCT03617185|182857923|SUPERIORITY||Mean Difference (Net)|2.7||||0.48|TWO_SIDED|95.0|-7.57|12.97||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||12.97|-7.57|0.48
91700832|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|95.0|-0.5|0.04||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.04|-0.50|0.10
91493426|NCT03617185|182857923|SUPERIORITY||Mean Difference (Net)|-0.87||||0.64|TWO_SIDED|95.0|-4.94|3.18||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||3.18|-4.94|0.64
91493427|NCT03617185|182857924|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.3||0.69|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.69
91493428|NCT03617185|182857924|SUPERIORITY||Median Difference (Net)|-0.3|STANDARD_DEVIATION|0.9||0.24|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.24
91493429|NCT03617185|182857924|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.1||0.45|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.45
91493430|NCT03617185|182857924|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.5||0.84|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.84
91493431|NCT03617185|182857925|SUPERIORITY||Mean Difference (Net)|-2.6||||0.09|TWO_SIDED|95.0|-5.66|0.44||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|t-test, 2 sided|||Mcgill Total Score||0.44|-5.66|0.09
91700833|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.24||||0.14|TWO_SIDED|95.0|-0.55|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.55|0.14
91700834|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.19||||0.07|TWO_SIDED|95.0|-0.39|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.39|0.07
91700835|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.22||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.22|-0.18|0.85
91700836|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.06|TWO_SIDED|95.0|-0.3|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.30|0.06
91700837|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.07||||0.51|TWO_SIDED|95.0|-0.14|0.28||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.28|-0.14|0.51
91700838|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.33||||0.001|TWO_SIDED|95.0|0.13|0.53||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.53|0.13|0.001
91700839|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.28||||0.04|TWO_SIDED|95.0|0.01|0.55||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.55|0.01|0.04
91700840|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.06||||0.36|TWO_SIDED|95.0|-0.19|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.19|0.36
91700841|NCT05897827|183296132|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.03||||0.62|TWO_SIDED|95.0|-0.16|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.16|0.62
91731621|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
91731622|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
91731623|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR?||||||1e-05|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR.||||0.00001
91731624|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0000
91731625|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
91493432|NCT03617185|182857925|SUPERIORITY||Mean Difference (Net)|-0.97||||0.56|TWO_SIDED|95.0|-4.36|2.41||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|t-test, 2 sided|||Mcgill Total Score||2.41|-4.36|0.56
91731626|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0008
91731627|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
91731628|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
91731629|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR.||||0.0005
91731630|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.0000
91731631|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
91731632|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0.4505|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.4505
91731633|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
91731634|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
91493433|NCT03617185|182857925|SUPERIORITY||Mean Difference (Net)|-1.72||||0.21|TWO_SIDED|95.0|-4.5|1.05||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|t-test, 2 sided|||Mcgill Total Score||1.05|-4.5|0.21
91731635|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR.||||1.0000
91731636|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
91731637|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
91731638|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
91731639|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
91731640|NCT02732145|183357814|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0005
91493434|NCT03617185|182857926|SUPERIORITY|||||||0.62||||||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|t-test, 2 sided|||||||0.62
91493435|NCT03617185|182857926|SUPERIORITY|||||||0.92||||||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|t-test, 2 sided|||||||0.92
91493436|NCT03617185|182857926|SUPERIORITY|||||||0.9||||||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|t-test, 2 sided|||||||0.90
91493437|NCT03617185|182857926|SUPERIORITY||Interaction term for difference in slope|-0.02||||0.46|TWO_SIDED|95.0|-0.06|0.03||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.03|-0.06|0.46
91731641|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR.||||0.0000
91731642|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR.||||0.0000
91731643|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR.||||0.0000
91731644|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR.||||0.0000
91731645|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR.||||0.0000
91731646|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR.||||0.0000
91731647|NCT02732145|183357815|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR.||||0.0000
91731648|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR?||||||0.8545|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR.||||0.8545
91731649|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.8569|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.8569
91493438|NCT03617185|182857926|SUPERIORITY||Interaction term for difference in slope|-0.02||||0.47|TWO_SIDED|95.0|-0.06|0.03||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.03|-0.06|0.47
91493439|NCT03617185|182857926|SUPERIORITY||Interaction term for difference in slope|0.003||||0.91|TWO_SIDED|95.0|-0.04|0.05||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||||0.05|-0.04|0.91
91731650|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.2478
91731651|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.2478
91731652|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
91731653|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.5943|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.5943
91731654|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.7161|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.7161
91731655|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.3301
91493440|NCT03617185|182857927|SUPERIORITY||Mean Difference (Net)|0.06||||0.83|TWO_SIDED|95.0|-0.53|0.65||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||NeuroQOL- overall QOL||0.65|-0.53|0.83
91700842|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.08|TWO_SIDED|95.0|-0.32|0.02||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.02|-0.32|0.08
91700843|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.21||||0.2|TWO_SIDED|95.0|-0.55|0.12||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.12|-0.55|0.20
91700844|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.02||||0.74|TWO_SIDED|95.0|-0.14|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.14|0.74
91700845|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.05||||0.55|TWO_SIDED|95.0|-0.12|0.23||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.23|-0.12|0.55
91700846|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.07||||0.4|TWO_SIDED|95.0|-0.22|0.09||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.09|-0.22|0.40
91700847|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.12||||0.36|TWO_SIDED|95.0|-0.37|0.13||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.13|-0.37|0.36
91700848|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.39|||<|0.001|TWO_SIDED|95.0|0.18|0.6||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.60|0.18|<0.001
91700849|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.12||||0.41|TWO_SIDED|95.0|-0.16|0.39||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.39|-0.16|0.41
91700850|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.22|0.2||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.20|-0.22|0.92
91700851|NCT05897827|183296133|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.14||||0.37|TWO_SIDED|95.0|-0.16|0.44||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.44|-0.16|0.37
91700852|NCT05897827|183296134|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.59||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.59|0.28|<0.001
91700853|NCT05897827|183296134|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.49|||<|0.001|TWO_SIDED|95.0|0.29|0.69||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.69|0.29|<0.001
91700854|NCT04599933|183296136|SUPERIORITY||Odds Ratio (OR)|2.916|||<|0.01|TWO_SIDED|95.0|1.663|5.113|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.113|1.663|<0.01
91700855|NCT04599933|183296137|SUPERIORITY||Odds Ratio (OR)|3.035|||<|0.01|TWO_SIDED|95.0|1.736|5.305|||Regression, Logistic|||||5.305|1.736|<0.01
91700856|NCT04599933|183296138|SUPERIORITY||Odds Ratio (OR)|4.751|||<|0.01|TWO_SIDED|95.0|2.694|8.379|||Regression, Logistic|||||8.379|2.694|<0.01
91700857|NCT04599933|183296139|SUPERIORITY||Odds Ratio (OR)|3.422|||<|0.01|TWO_SIDED|95.0|1.923|6.09|||Regression, Logistic|||||6.090|1.923|<0.01
91700858|NCT01643798|183296163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91700859|NCT01643798|183296163|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
91700860|NCT01643798|183296164|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||||||.0003
91700861|NCT01643798|183296164|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||ANOVA|||||||0.794
91700862|NCT01911780|183296169|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-7.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.7|-5.3|||LOCF-ANCOVA|Last observation carried forward (LOCF) was used as the imputation method|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.|||-5.3|-9.7|<0.0001
91700863|NCT01911780|183296170|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-8.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-12.7|-4.5||Additional information, the p-value is not adjusted for multiplicity.|LOCF-ANCOVA||Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.|||-4.5|-12.7|<0.0001
91700864|NCT01911780|183296171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.0052|TWO_SIDED|95.0|1.4|7.1||Additional information, the p-value is not adjusted for multiplicity.|Regression, Logistic|Non-completers considered failures (NCF) was used as the imputation method.|Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.|||7.1|1.4|0.0052
91493441|NCT03617185|182857927|SUPERIORITY||Mean Difference (Net)|0.01||||0.97|TWO_SIDED|95.0|-0.76|0.78||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||NeuroQOL- overall QOL||0.78|-0.76|0.97
91700865|NCT01911780|183296173|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.1|2.3|||mixed-effects model repeated measures||As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||2.3|-3.1|
91493442|NCT03617185|182857927|SUPERIORITY||Mean Difference (Net)|-0.09||||0.76|TWO_SIDED|95.0|-0.73|0.54||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||NeuroQOL- overall QOL||0.54|-0.73|0.76
91700866|NCT01911780|183296174|SUPERIORITY_OR_OTHER||Adjusted Mean|2.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-1.5|6.1|||mixed-effects model repeated measures||Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||6.1|-1.5|
91700867|NCT03833804|183296186|NON_INFERIORITY|The investigators conducted a noninferiority analysis using a prespecified margin of 0.5%. The noninferiority margin was selected based on expert input from addiction medicine clinicians and implementation scientists, who agreed that a 0.5% absolute difference in the composite intervention rate would be clinically acceptable given the workflow and scalability benefits of automation. The margin was chosen to reflect a reasonable balance between clinical impact and operational gain.|z-test|0.86||||0.2|TWO_SIDED||||||One-sided independent samples z-test|||||||0.20
91700868|NCT02677896|183296191|SUPERIORITY||Cox hazard ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|rPFS Treatment Comparison||0.50|0.30|<0.0001
91700869|NCT02677896|183296192|SUPERIORITY||Cox proportional hazards model|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5|||Log Rank|||rPFS Treatment Comparision||0.50|0.30|<0.0001
91700870|NCT02677896|183296193|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Log Rank|P-value from stratified log-rank test.|Significance level is 0.04. Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.81|0.53|<0.0001
91700871|NCT02677896|183296194|SUPERIORITY||Cox hazard ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.26||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to PSA Progression Treatment Comparison||0.26|0.13|<0.0001
91700872|NCT02677896|183296195|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.31|0.48|||||Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.48|0.31|
91700873|NCT02677896|183296196|SUPERIORITY||Difference in rate|50.5|||<|0.0001|TWO_SIDED|95.0|45.3|55.7||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||PSA Undetectable Rate Treatment Comparison||55.7|45.3|<0.0001
91700874|NCT02677896|183296197|SUPERIORITY||Difference in rate|19.3|||<|0.0001|TWO_SIDED|95.0|10.4|28.2||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||ORR Treatment Comparison||28.2|10.4|<0.0001
91700875|NCT02677896|183296198|SUPERIORITY||Cox hazard ratio|0.88||||0.2162|TWO_SIDED|95.0|0.72|1.08||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Deterioration of Urinary Symptoms Treatment Comparison||1.08|0.72|0.2162
91493443|NCT03617185|182857928|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_DEVIATION|2.6||0.58|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.58
91700876|NCT02677896|183296199|SUPERIORITY||Cox hazard ratio|0.52||||0.0026|TWO_SIDED|95.0|0.33|0.8|||Log Rank|||Time to SSE Treatment Comparison||0.80|0.33|0.0026
91700877|NCT02677896|183296200|SUPERIORITY||Cox hazard ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.22|0.36|||Log Rank|||Time to Castration Resistance Treatment Comparison||0.36|0.22|<0.0001
91700878|NCT02677896|183296201|SUPERIORITY||Cox hazard ratio|0.96||||0.6548|TWO_SIDED|95.0|0.81|1.14|||Log Rank|||Time to Deterioration of QoL in FACT-P Treatment Comparison||1.14|0.81|0.6548
91700879|NCT02677896|183296202|SUPERIORITY||Cox hazard ratio|0.92||||0.2715|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||Time to Pain Progression Based on BPI-SF Treatment Comparison||1.07|0.78|0.2715
91700880|NCT02729038|183296211|OTHER||Ratio of geometric LS means|1.507|||||TWO_SIDED|90.0|0.902|2.519|||||AUC (0-inf) for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.519|0.902|
91700881|NCT02729038|183296211|OTHER||Ratio of geometric LS means|1.924|||||TWO_SIDED|90.0|1.151|3.215|||||AUC (0-inf) for participants with normal renal function Vs participants with Severe/ESRD not on hemodialysis|||3.215|1.151|
91700882|NCT02729038|183296212|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.421|3.969|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||3.969|1.421|
91700883|NCT02729038|183296212|OTHER||Ratio of geometric LS means|4.075|||||TWO_SIDED|90.0|2.438|6.81|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||6.810|2.438|
91700884|NCT02729038|183296213|OTHER||Ratio of geometric LS means|1.179|||||TWO_SIDED|90.0|0.467|2.977|||||Cmax for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.977|0.467|
91700885|NCT02729038|183296213|OTHER||Ratio of geometric LS means|1.575|||||TWO_SIDED|90.0|0.624|3.975|||||Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis|||3.975|0.624|
91700886|NCT02729038|183296214|OTHER||Ratio of geometric LS means|2.25|||||TWO_SIDED|90.0|0.891|5.681|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||5.681|0.891|
91493444|NCT03617185|182857928|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.0||0.8|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.80
91493445|NCT03617185|182857928|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.4||0.86|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.86
91493446|NCT03617185|182857928|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|1.4||0.46|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.46
91700887|NCT02729038|183296214|OTHER||Ratio of geometric LS means|5.966|||||TWO_SIDED|90.0|2.363|15.062|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||15.062|2.363|
91700888|NCT02729038|183296236|OTHER||Ratio of geometric LS means|1.501|||||TWO_SIDED|90.0|0.894|2.52|||||Normal Vs Moderate|||2.520|0.894|
91700889|NCT02729038|183296236|OTHER||Ratio of geometric LS means|1.912|||||TWO_SIDED|90.0|1.139|3.212|||||Normal Vs Severe/ESRD not on hemodialysis|||3.212|1.139|
91700890|NCT02729038|183296237|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.414|3.989|||||Normal Vs ESRD on hemodialysis (before hemodialysis)|||3.989|1.414|
91700891|NCT02729038|183296237|OTHER||Ratio of geometric LS means|4.068|||||TWO_SIDED|90.0|2.422|6.831|||||Normal Vs ESRD on hemodialysis (after hemodialysis)|||6.831|2.422|
91700892|NCT03687372|183296267|SUPERIORITY||Mean Difference (Final Values)|3.22||||0.0003|TWO_SIDED|95.0|1.67|6.22||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||6.22|1.67|0.0003
91700893|NCT03687372|183296268|SUPERIORITY|P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|1.3|3.52|||Mixed Models Analysis|||||3.52|1.30|0.0024
91700894|NCT03687372|183296269|SUPERIORITY||Odds Ratio (OR)|14.12|||<|0.0001|TWO_SIDED|95.0|7.5|20.8|||Wilcoxon (Mann-Whitney)|||||20.8|7.5|<0.0001
91700895|NCT03687372|183296270|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0009|TWO_SIDED|95.0|1.55|6.65|||Wilcoxon (Mann-Whitney)|||||6.65|1.55|0.0009
91700896|NCT03687372|183296271|SUPERIORITY||Hazard Ratio (HR)|2.56|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
91700897|NCT01482962|183296288|SUPERIORITY||Odds Ratio (OR)|0.6||||0.038|TWO_SIDED|95.0|0.33|1.08||P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.|Cochran-Mantel-Haenszel|||||1.08|0.33|0.038
91700898|NCT01482962|183296289|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.637|1.178|||Stratified Log Rank||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.178|0.637|0.177
91700899|NCT01482962|183296290|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.338|TWO_SIDED|95.0|0.707|1.369|||Stratified Log-rank Test||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.369|0.707|0.338
91700900|NCT01482962|183296295|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.362|TWO_SIDED|95.0|0.679|1.329|||Stratified Log Rank||Hazard ratio was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.329|0.679|0.362
91700901|NCT01152359|183296316|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|-0.8|2.9|||Mixed Models Analysis|||||2.9|-0.8|<0.05
91700902|NCT01152359|183296317|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.66|TWO_SIDED|95.0|-4.9|3.1|||Mixed Models Analysis|||||3.1|-4.9|0.66
91700903|NCT01152359|183296318|SUPERIORITY||Mean Difference (Net)|-0.8||||0.65|TWO_SIDED|95.0|-4.1|2.6|||Mixed Models Analysis|||||2.6|-4.1|0.65
91493447|NCT03617185|182857929|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_DEVIATION|2.7||0.38|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.38
91493448|NCT03617185|182857929|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_DEVIATION|1.15||0.72|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.72
91493449|NCT03617185|182857929|SUPERIORITY||Mean Difference (Net)|-0.31|STANDARD_DEVIATION|2.07||0.55|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.55
91493450|NCT03617185|182857929|SUPERIORITY||Mean Difference (Net)|0.57|STANDARD_DEVIATION|2.7||0.28|TWO_SIDED|||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.28
91493451|NCT03617185|182857930|SUPERIORITY|||||||0.54||||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.54
91493452|NCT03617185|182857930|SUPERIORITY|||||||1||||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||1.00
91700904|NCT01210495|183296375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.2872|TWO_SIDED|95.0|0.646|1.274||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio less than (\<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (\>) 1 indicated reduction to favor Placebo.|The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent \[%\] improvement in median OS).||1.274|0.646|0.2872
91700905|NCT01210495|183296376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.0039|TWO_SIDED|95.0|0.438|0.871||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.871|0.438|0.0039
91700906|NCT01210495|183296377|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.172||||0.0914|TWO_SIDED|95.0|0.759|13.265||ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.|Cochran-Mantel-Haenszel||Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||13.265|0.759|0.0914
91700907|NCT01210495|183296378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.006|TWO_SIDED|95.0|0.434|0.889||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.889|0.434|0.006
91700908|NCT01210495|183296380|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.65||||0.0025|TWO_SIDED|95.0|1.319|5.326||For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.|Cochran-Mantel-Haenszel||Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||5.326|1.319|0.0025
91700909|NCT01210495|183296389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.89||||0.0006|TWO_SIDED|95.0|-18.7|-5.08||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.08|-18.70|0.0006
91700910|NCT01210495|183296390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.0014|TWO_SIDED|95.0|-12.27|-2.94||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.94|-12.27|0.0014
91700911|NCT01210495|183296391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|95.0|-4.76|-1.78||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.78|-4.76|<0.0001
91700912|NCT01210495|183296392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.21|-5.26|<0.0001
91493453|NCT03617185|182857930|SUPERIORITY|||||||0.77||||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.77
91493454|NCT03617185|182857930|SUPERIORITY|||||||0.24||||||The P-value tests whether the within-participant change in the group from baseline to 2 years is significant|t-test, 2 sided|||||||0.24
91493455|NCT03617185|182857931|SUPERIORITY||Mean Difference (Net)|-2.0||||0.36|TWO_SIDED|95.0|-6.37|2.36||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||2.36|-6.37|0.36
91493456|NCT03617185|182857931|SUPERIORITY||Mean Difference (Net)|4.5|||<|0.01|TWO_SIDED|95.0|1.31|7.71||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||7.71|1.31|<0.01
91493457|NCT03617185|182857931|SUPERIORITY||Mean Difference (Net)|5.62||||0.3|TWO_SIDED|95.0|-5.37|16.63||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||||16.63|-5.37|0.30
91493458|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|3.14||||0.16|TWO_SIDED|95.0|-1.3|7.58||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Inhibitory Control and Attention Test||7.58|-1.30|0.16
91493459|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|1.91||||0.33|TWO_SIDED|95.0|-2.05|5.88||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Inhibitory Control and Attention Test||5.88|-2.05|0.33
91700913|NCT01210495|183296392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.1642|TWO_SIDED|95.0|-3.07|0.52||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.52|-3.07|0.1642
91700914|NCT01210495|183296392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.4759|TWO_SIDED|95.0|-1.8|0.84||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.84|-1.80|0.4759
91700915|NCT01210495|183296392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07||||0.0288|TWO_SIDED|95.0|-3.92|-0.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.21|-3.92|0.0288
91700916|NCT01210495|183296393|SUPERIORITY||Mean Difference (Final Values)|-4.96||||0.0011|TWO_SIDED|95.0|-7.93|-1.99||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.99|-7.93|0.0011
91700917|NCT01210495|183296394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.45|||<|0.0001|TWO_SIDED|95.0|-15.49|-5.42||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.42|-15.49|<0.0001
91700918|NCT01210495|183296395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.252||||0.9182|TWO_SIDED|95.0|0.923|1.698||The p-value is from a 1-sided log-rank test.|1-sided, unstratified log-rank test||Assuming proportional hazards, a hazard ratio \<1 indicates reduction in hazard rate to favor Axitinib, hazard ratio \>1 indicates reduction to favor Placebo.|||1.698|0.923|0.9182
91700919|NCT01210495|183296396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.0024|TWO_SIDED|95.0|-0.2|-0.04|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.04|-0.20|0.0024
91700920|NCT01210495|183296397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03||||0.0193|TWO_SIDED|95.0|-12.91|-1.15|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.15|-12.91|0.0193
91700921|NCT00640653|183296434|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.03|TWO_SIDED|95.0|0.48|0.96||The significance criterion was set at alpha = .05.|generalized linear regression|Log link was specified|Treatment was coded as 1 vs health control coded as 0.|With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.||0.96|0.48|.03
91700922|NCT02938949|183296439|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91700923|NCT02938949|183296440|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||> 0.20
91700924|NCT02938949|183296441|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||>0.20
91700925|NCT01500213|183296460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.043|TWO_SIDED|95.0|1.0|2.1||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.1|1.0|0.043
91700926|NCT01500213|183296461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.233|TWO_SIDED|95.0|0.8|2.0||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|0.8|0.233
91700927|NCT01500213|183296462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.084|TWO_SIDED|95.0|1.0|1.9||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.9|1.0|0.084
91700928|NCT04027075|183296463|SUPERIORITY||Odds Ratio (OR)|1.02||||0.962|TWO_SIDED|95.0|0.51|2.02|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.02|0.51|.962
91700929|NCT04027075|183296464|SUPERIORITY||Odds Ratio (OR)|0.47||||0.109|TWO_SIDED|95.0|0.19|1.18|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||1.18|0.19|.109
91700930|NCT04027075|183296465|SUPERIORITY||Odds Ratio (OR)|1.58||||0.227|TWO_SIDED|95.0|0.75|3.29|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.29|0.75|.227
91493460|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|1.43||||0.49|TWO_SIDED|95.0|-2.72|5.59||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Inhibitory Control and Attention Test||5.59|-2.72|0.49
91493461|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|2.97||||0.35|TWO_SIDED|95.0|-3.48|9.44||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Dimensional Change Card Sort Test||9.44|-3.48|0.35
91493462|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|5.6||||0.1|TWO_SIDED|95.0|-3.48|9.44||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Dimensional Change Card Sort Test||9.44|-3.48|0.10
91493463|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|3.24||||0.32|TWO_SIDED|95.0|-3.34|9.82||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Dimensional Change Card Sort Test||9.82|-3.34|0.32
91493464|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|2.4||||0.49|TWO_SIDED|95.0|-4.57|9.37||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Picture Sequence Memory Test||9.37|-4.57|0.49
91493465|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|3.2||||0.3|TWO_SIDED|95.0|-3.03|9.56||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Picture Sequence Memory Test||9.56|-3.03|0.30
91493466|NCT03617185|182857932|SUPERIORITY||Median Difference (Net)|0.49||||0.86|TWO_SIDED|95.0|-5.4|6.38||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Picture Sequence Memory Test||6.38|-5.40|0.86
91493467|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|0.42||||0.88|TWO_SIDED|95.0|-5.39|6.24||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||List Sorting Working Memory Test||6.24|-5.39|0.88
91493468|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|0.6||||0.83|TWO_SIDED|95.0|-5.14|6.31||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||List Sorting Working Memory Test||6.31|-5.14|0.83
91700931|NCT04027075|183296466|SUPERIORITY||Odds Ratio (OR)|1.2||||0.681|TWO_SIDED|95.0|0.5|2.87|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.87|0.50|.681
91700932|NCT04027075|183296467|SUPERIORITY||Odds Ratio (OR)|1.18||||0.65|TWO_SIDED|95.0|0.58|2.42|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.42|0.58|.650
91493469|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|-0.62||||0.81|TWO_SIDED|95.0|-6.02|4.76||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||List Sorting Working Memory Test||4.76|-6.02|0.81
91493470|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|-5.29||||0.12|TWO_SIDED|95.0|-12.1|1.57||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Pattern Comparison Processing Speed Test||1.57|-12.1|0.12
91493471|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|-1.84||||0.63|TWO_SIDED|95.0|-9.53|5.84||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Pattern Comparison Processing Speed Test||5.84|-9.53|0.63
91493472|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|-2.87||||0.4|TWO_SIDED|95.0|-9.8|4.05||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Pattern Comparison Processing Speed Test||4.05|-9.80|0.40
91493473|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|1.04||||0.65|TWO_SIDED|95.0|-3.63|5.73||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Cognition Fluid Composite||5.73|-3.63|0.65
91493474|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|2.68||||0.27|TWO_SIDED|95.0|-2.17|7.54||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Cognition Fluid Composite||7.54|-2.17|0.27
91493475|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|0.27||||0.9|TWO_SIDED|95.0|-4.1|4.65||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Cognition Fluid Composite||4.65|-4.10|0.90
91700933|NCT04027075|183296468|SUPERIORITY||Odds Ratio (OR)|1.41||||0.304|TWO_SIDED|95.0|0.73|2.73|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.73|0.73|.304
91700934|NCT04027075|183296469|SUPERIORITY||Odds Ratio (OR)|1.44||||0.97|TWO_SIDED|95.0|0.69|3.0|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.00|0.69|0.97
91493476|NCT03617185|182857932|SUPERIORITY||Interaction term for difference in slope|-0.02||||0.85|TWO_SIDED|95.0|-0.21|0.17||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Cognition Fluid Composite||0.17|-0.21|0.85
91700935|NCT04027075|183296470|SUPERIORITY||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.005
91700936|NCT04027075|183296471|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.09||0.46|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.460
91700937|NCT04027075|183296472|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.26||0.851|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.851
91700938|NCT04027075|183296473|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.977|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.977
91700939|NCT04027075|183296474|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.456|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.456
91700940|NCT04027075|183296475|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.31||0.874|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.874
91700941|NCT04027075|183296476|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.24||0.069|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.069
91700942|NCT04027075|183296477|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.658|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.658
91700943|NCT04027075|183296478|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.783|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.783
91700944|NCT00195494|183296513|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.0|||<|0.001|||||||Fisher Exact||E+M (49.8%) - M (27.8%) creates the risk difference estimated value.|||||<0.001
91700945|NCT00195494|183296514|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|||<|0.001|||||||Fisher Exact||E+M (79.7%) - M (58.7%) creates the risk difference estimated value.|||||<0.001
91700946|NCT00347919|183296557|SUPERIORITY_OR_OTHER||Percentage difference|2.7||||0.3724||90.0|-11.0|16.3|||Chi-squared||Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||16.3|-11.0|0.3724
91700947|NCT00347919|183296557|SUPERIORITY_OR_OTHER||Percentage difference|5.4||||0.2578||90.0|-8.4|19.2|||Chi-squared||Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||19.2|-8.4|0.2578
91700948|NCT00347919|183296558|SUPERIORITY_OR_OTHER|||||||0.7488||95.0|||||Log Rank|||||||0.7488
91700949|NCT01187498|183296585|NON_INFERIORITY_OR_EQUIVALENCE|A power analysis indicated that a sample size of 70 per group would provide 80% power with a one-sided alpha of 0.05 to declare two means equivalent, assuming a mean voiding frequency of 8.2 for behavioral treatment, a mean voiding frequency of 8.0 for drug therapy, and a standard deviation of 2.3 for both groups. Equivalence was defined as ±15% of the drug therapy posttreatment mean.|Difference of the Means|0.4|STANDARD_ERROR_OF_MEAN|0.346||0.001||95.0|||||Regression, Linear||The estimated parameter of dispersion is the standard error of the regression coefficient which measured the adjusted difference of the group means.|The primary analysis was an equivalence analysis to compare the two treatment groups on posttreatment 24- hour voiding frequency using a margin of ±15% of the drug group mean. Schuirmann's two one-sided tests (TOST) approach was used first to examine completers and then repeated using last observation carried forward to include participants who did not complete therapy. Adjusting the test to regression, the analyses were repeated using baseline voiding frequency as a covariate.||||.001
91700950|NCT01187498|183296586|SUPERIORITY_OR_OTHER||Difference of the Means|-0.38|STANDARD_ERROR_OF_MEAN|0.188||0.05||95.0|||||Regression, Linear||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
91700951|NCT01187498|183296587|SUPERIORITY_OR_OTHER||Difference of Group Means|0.19|STANDARD_ERROR_OF_MEAN|0.091||0.05||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
91493477|NCT03617185|182857932|SUPERIORITY||Interaction term for difference in slope|-0.1||||0.28|TWO_SIDED|95.0|-0.29|0.09||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Cognition Fluid Composite||0.09|-0.29|0.28
91700952|NCT01187498|183296588|SUPERIORITY_OR_OTHER||Difference in Group Means|-0.14|STANDARD_ERROR_OF_MEAN|0.091||0.33||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.33
91700953|NCT01187498|183296589|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.924||0.84||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.84
91700954|NCT01187498|183296590|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|-0.0563|STANDARD_ERROR_OF_MEAN|0.1249||0.69||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.69
91700955|NCT01187498|183296591|SUPERIORITY_OR_OTHER||Difference between Group Weighted Means|-0.1563|STANDARD_ERROR_OF_MEAN|0.1009||0.16||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.16
91700956|NCT01187498|183296592|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.1079|STANDARD_ERROR_OF_MEAN|0.1625||0.56||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.56
91700957|NCT01187498|183296593|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.054|STANDARD_ERROR_OF_MEAN|0.1265||0.65||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.65
91700958|NCT01187498|183296594|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.01
91700959|NCT01187498|183296595|SUPERIORITY_OR_OTHER||Difference in Group Proportions|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.02||95.0|||||Chi-squared||The estimated parameter of dispersion represents the standard error for the difference of the group proportions.|Cochran Mantel-Haenszel procedure.||||.02
91700960|NCT01970475|183296596|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).|Risk Ratio (RR)|1.039|||||TWO_SIDED|90.0|0.954|1.133|||||Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.|The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.||1.133|0.954|
91700961|NCT03495154|183296666|OTHER|This was not a comparative endpoint.|Percentage and confidence interval|3.3|||||TWO_SIDED|95.0|1.0|8.5||||||Number of participants with hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair||8.5|1.0|
91700962|NCT03495154|183296667|OTHER|Statistical Analysis is based on number of participants with incidence of with ADEs at discharge. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|14.0|||||TWO_SIDED|||||||||||||
91700963|NCT03495154|183296667|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 1 month. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|31.0|||||TWO_SIDED|||||||||||||
91700964|NCT03495154|183296667|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 3 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|34.0|||||TWO_SIDED|||||||||||||
91700965|NCT03495154|183296667|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 12 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|40.0|||||TWO_SIDED|||||||||||||
91700966|NCT03495154|183296667|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 24 months. Adverse Device Effects (ADEs) are inclusive of both procedure and device related AEs.|Number of Subjects with ADEs|42.0|||||TWO_SIDED|||||||||||||
91700967|NCT03495154|183296668|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 1M|0.0|||||TWO_SIDED|95.0|0.0|2.9||||||||2.9|0|
91700968|NCT03495154|183296668|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 3M|0.0|||||TWO_SIDED|95.0|0.0|3.0||||||||3.0|0|
91700969|NCT03495154|183296668|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 24M|4.0|||||TWO_SIDED|95.0|1.2|9.6||||||||9.6|1.2|
91700970|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.75|1.17|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 3||1.17|0.75|<0.001
91493478|NCT03617185|182857932|SUPERIORITY||Mean Difference (Net)|0.001||||0.99|TWO_SIDED|95.0|-0.18|0.19||The P-value tests for association between the outcome and treatment at each visit, compared to the no-treatment group|Mixed Models Analysis|||Cognition Fluid Composite||0.19|-0.18|0.99
91493479|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|-0.19||||0.57|TWO_SIDED|95.0|-0.87|0.49||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Auditory Learning||0.49|-0.87|0.57
91700971|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.88|1.33|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 7F||1.33|0.88|<0.001
91493480|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|-0.26||||0.33|TWO_SIDED|95.0|-0.81|0.28||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Auditory Learning||0.28|-0.81|0.33
91493481|NCT03617185|182857933|SUPERIORITY||Median Difference (Net)|-0.38||||0.22|TWO_SIDED|95.0|-1.0|0.23||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Auditory Learning||0.23|-1.00|0.22
91731656|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.3301
91700972|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.93|1.36|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 8||1.36|0.93|<0.001
91700973|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.86|1.29|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 9N||1.29|0.86|<0.001
91700974|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.14|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 10A||2.14|1.28|<0.001
91700975|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.52|||<|0.001|TWO_SIDED|95.0|1.2|1.92|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 11A||1.92|1.20|<0.001
91700976|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.43|2.72|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 12F||2.72|1.43|<0.001
91700977|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.28|2.0|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 17F||2.00|1.28|<0.001
91700978|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|0.93|1.45|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 19A||1.45|0.93|<0.001
91700979|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.44|||<|0.001|TWO_SIDED|95.0|1.18|1.77|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 20A||1.77|1.18|<0.001
91731657|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
91493482|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|0.29||||0.27|TWO_SIDED|95.0|-0.23|0.81||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Delayed Recall||0.81|-0.23|0.27
91493483|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|-0.16||||0.54|TWO_SIDED|95.0|-0.69|0.37||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Delayed Recall||0.37|-0.69|0.54
91493484|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|-0.02||||0.93|TWO_SIDED|95.0|-0.57|0.53||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Delayed Recall||0.53|-0.57|0.93
91700980|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.1|1.76|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 22F||1.76|1.10|<0.001
91493485|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|0.14||||0.64|TWO_SIDED|95.0|-0.46|0.74||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Recognition||0.74|-0.46|0.64
91493486|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|-0.21||||0.37|TWO_SIDED|95.0|-0.7|0.27||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Recognition||0.27|-0.70|0.37
91493487|NCT03617185|182857933|SUPERIORITY||Mean Difference (Net)|0.04||||0.88|TWO_SIDED|95.0|-0.59|0.69||The P-value tests whether the within-participant change in the outcome from baseline to 2 years differs between the treatment and no-treatment groups.|t-test, 2 sided|||Recognition||0.69|-0.59|0.88
91493488|NCT01964430|182857938|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1824|TWO_SIDED|95.0|0.729|1.063|||Log Rank|Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).|||1.063|0.729|0.1824
91493489|NCT01964430|182857939|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0128|TWO_SIDED|95.0|0.691|0.957|||Log Rank|Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus|||0.957|0.691|0.0128
91700981|NCT05633992|183296690|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.68|1.12|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 33F||1.12|0.68|<0.001
91700982|NCT05633992|183296690|NON_INFERIORITY|For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.43|||<|0.001|TWO_SIDED|95.0|1.07|1.89|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15B||1.89|1.07|<0.001
91731658|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.4742|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.4742
91731659|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.1822
91493490|NCT00578383|182857963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|1.17||0.009|TWO_SIDED|95.0|0.5|5.8||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||5.8|0.5|0.009
91513267|NCT02710630|182898021|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|54.12|STANDARD_DEVIATION|138.6|||TWO_SIDED|90.0|35.818|81.774|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||81.774|35.818|
91731660|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.1822
91513268|NCT02710630|182898021|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|58.96|STANDARD_DEVIATION|71.4|||TWO_SIDED|90.0|45.489|76.431|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.431|45.489|
91493491|NCT00578383|182857964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|0.2|1.9||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.||1.9|0.2|0.006
91700983|NCT05633992|183296690|SUPERIORITY|For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>1.0 (one-sided p-value \<0.025).|Day 30 GMT Ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.56|2.7|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15C||2.70|1.56|<0.001
91700984|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.6|||<|0.001|TWO_SIDED|95.0|17.8|36.9|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 6A||36.9|17.8|<0.001
91700985|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.0|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 15A||43.0|23.6|<0.001
91700986|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.8|46.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 16F||46.4|29.8|<0.001
91700987|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|29.5|||<|0.001|TWO_SIDED|95.0|17.4|40.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23A||40.6|17.4|<0.001
91700988|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.3|46.7|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23B||46.7|29.3|<0.001
91700989|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.1|||<|0.001|TWO_SIDED|95.0|18.3|35.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 24F||35.6|18.3|<0.001
91700990|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|57.3|||<|0.001|TWO_SIDED|95.0|49.3|64.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 31||64.4|49.3|<0.001
91700991|NCT05633992|183296691|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|47.0|||<|0.001|TWO_SIDED|95.0|39.5|54.1|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 35B||54.1|39.5|<0.001
91700992|NCT02339155|183296730|NON_INFERIORITY|If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.|Ratio|1.18||||0.0016|TWO_SIDED|90.0|1.03|1.35|||t-test, 1 sided|||||1.35|1.03|0.0016
91700993|NCT02339155|183296731|OTHER||Ratio|1.09|||||TWO_SIDED|90.0|0.98|1.22|||t-test, 1 sided||Week 8|||1.22|0.98|
91700994|NCT02339155|183296731|OTHER||Ratio|0.98|||<|0.0001|TWO_SIDED|90.0|0.89|1.07|||t-test, 1 sided||Week 26|||1.07|0.89|<0.0001
91700995|NCT02102100|183296768|OTHER||Mean Difference (Net)|0.9436|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Least square means and standard errors were calculated to describe the patterns of means for each outcome. Effect slices were tested to explain significant interactions in the models. Pairwise comparisons of least square means were used to describe significant main effects.||||<.0001
91700996|NCT05014815|183296769|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4698|TWO_SIDED|95.0|0.74|1.33||1-sided p-value|Log Rank|Stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.33|0.74|0.4698
91731661|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.0927|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0927
91731662|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.036|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0360
91528647|NCT01984424|182933084|SUPERIORITY||LS Mean Treatment Difference|-36.07|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|95.0|-41.07|-31.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-31.08|-41.07|<0.0001
91700997|NCT05014815|183296770|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.47|1.26|||||The Mantel-Haenszel common OR and its 95% CI were estimated using a normal approximation of the log odds ratio and the Robins-Breslow-Greenland variance, stratified by PD-L1 expression and histology.|||1.26|0.47|
91700998|NCT05014815|183296772|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.67|1.34|||||The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.34|0.67|
91700999|NCT02634268|183296850|SUPERIORITY||Mean Difference (Final Values)|42.3||||0.02|TWO_SIDED|95.0|7.93|76.6|||Mixed Models Analysis|Difference in average six minute walk test distance at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||76.6|7.93|.02
91701000|NCT02634268|183296851|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0008|TWO_SIDED|95.0|-0.63|-0.09|||Mixed Models Analysis|Difference in average Modified Borg Scale score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.09|-0.63|.0008
91701001|NCT02634268|183296852|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.0008|TWO_SIDED|95.0|-2.33|-0.34|||Mixed Models Analysis|Difference in average body weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.34|-2.33|0.0008
91701002|NCT02634268|183296853|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.01|TWO_SIDED|95.0|0.35|2.6|||Mixed Models Analysis|Difference in average SF-12 PCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||2.60|0.35|0.01
91701003|NCT02634268|183296854|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.45|TWO_SIDED|95.0|-0.84|1.89|||Mixed Models Analysis|Difference in average SF-12 MCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.89|-0.84|0.45
91701004|NCT02634268|183296855|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.009|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Models Analysis|Difference in average Framingham Risk Score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.10|-0.71|0.009
91701005|NCT02634268|183296856|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.13|TWO_SIDED|95.0|-2.12|0.26|||Mixed Models Analysis|Difference in average waist circumference at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.26|-2.12|0.13
91731663|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR.||||0.0720
91731664|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||1.0000
91731665|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
91731666|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
91731667|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.5987|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.5987
91731668|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR?||||||0.4164|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR.||||0.4164
91731669|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||0.0720
91731670|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.0148|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.0148
91493492|NCT00578383|182857965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|1.24||0.001|TWO_SIDED|95.0|1.3|6.9||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).||6.9|1.3|0.001
91528648|NCT01984424|182933085|SUPERIORITY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|-84.7|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-67.0|-84.7|<0.0001
91731671|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.0085|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.0085
91493493|NCT00578383|182857966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.39||0.15|TWO_SIDED|95.0|-1.1|5.1||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)||5.1|-1.1|0.15
91731672|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.1918
91731673|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR?||||||0.3037|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR.||||0.3037
91731674|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
91493494|NCT00578383|182857967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.09|TWO_SIDED|95.0|-1.2|6.2||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.||6.2|-1.2|0.09
91493495|NCT00578383|182857968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|2.11||0.19|TWO_SIDED|95.0|-3.3|9.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||9.6|-3.3|0.19
91731675|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
91731676|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR?||||||0.0877|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR.||||0.0877
91731677|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR?||||||0.7726|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR.||||0.7726
91731678|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR?||||||0.0191|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR.||||0.0191
91731679|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.0287
91731680|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.6374|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.6374
91731681|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.7512|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.7512
91731682|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2734|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2734
91731683|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0287
91731684|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.8732
91731685|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0602|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0602
91493496|NCT00578383|182857969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.51||0.15|TWO_SIDED|95.0|-0.6|2.1||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.||2.1|-0.6|0.15
91493497|NCT00578383|182857970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.67||0.04|TWO_SIDED|95.0|-0.4|3.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.||3.6|-0.4|0.04
91513269|NCT02710630|182898021|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.38|STANDARD_DEVIATION|57.0|||TWO_SIDED|90.0|85.846|131.836|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||131.836|85.846|
91513270|NCT02710630|182898021|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|103.73|STANDARD_DEVIATION|43.3|||TWO_SIDED|90.0|87.74|122.628|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||122.628|87.740|
91493498|NCT00578383|182857971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|1.67||0.004|TWO_SIDED|95.0|0.8|9.2||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)||9.2|0.8|0.004
91493499|NCT00578383|182857972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.58||0.3|TWO_SIDED|95.0|1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)||5.8|1.3|0.30
91493500|NCT00578383|182857973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.01||0.52|TWO_SIDED|95.0|-4.1|6.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)||6.8|-4.1|0.52
91493501|NCT00578383|182857974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.43||0.1||95.0|-1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)||5.8|-1.3|0.10
91493502|NCT03385564|182857989|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-5.68||||0.7957|TWO_SIDED|80.0|-34.192|22.825|||Regression, Logistic||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||22.825|-34.192|0.7957
91731686|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0079|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0079
91701006|NCT02634268|183296857|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.64|TWO_SIDED|95.0|-3.02|1.84|||Mixed Models Analysis|Difference in average 12 month systolic blood at 12 months between control and intervention groups|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.84|-3.02|0.64
91493503|NCT03385564|182857989|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-9.37||||0.5811|TWO_SIDED|80.0|-31.178|12.44|||Regression, Logistic||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||12.440|-31.178|0.5811
91493504|NCT03385564|182857989|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|1.97||||0.8972|TWO_SIDED|80.0|-17.534|21.48|||Regression, Logistic||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||21.480|-17.534|0.8972
91493505|NCT03385564|182857990|OTHER||Difference|-9.14||||0.825|TWO_SIDED|80.0|-32.83|17.02|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||17.02|-32.83|0.8250
91701007|NCT02634268|183296858|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.004|TWO_SIDED|95.0|-0.85|-0.17|||Mixed Models Analysis|Difference in average BMI at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.17|-0.85|0.004
91731687|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2081|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2081
91731688|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.8732
91493506|NCT03385564|182857990|OTHER||Difference|-21.23||||0.2562|TWO_SIDED|80.0|-39.44|0.51|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||0.51|-39.44|0.2562
91493507|NCT03385564|182857990|OTHER||Difference|-2.0||||0.9632|TWO_SIDED|80.0|-20.45|16.62|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||16.62|-20.45|0.9632
91528649|NCT01984424|182933086|SUPERIORITY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|95.0|-81.3|-62.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-62.2|-81.3|<0.0001
91528650|NCT01984424|182933087|SUPERIORITY||Treatment Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.1|36.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.7|19.1|<0.0001
91528651|NCT01984424|182933088|SUPERIORITY||Treatment Difference|27.4|||<|0.0001|TWO_SIDED|95.0|17.7|36.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.1|17.7|<0.0001
91528652|NCT01984424|182933089|SUPERIORITY||LS Mean Treatment Difference|-26.61|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-29.95|-23.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-23.27|-29.95|<0.0001
91528653|NCT01984424|182933090|SUPERIORITY||LS Mean Treatment Difference|-25.08|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED|95.0|-28.67|-21.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-21.48|-28.67|<0.0001
91701008|NCT02634268|183296859|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.09|TWO_SIDED|95.0|-4.87|0.36|||Mixed Models Analysis|Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|0.36|-4.87|0.09
91528654|NCT01984424|182933091|SUPERIORITY||LS Mean Treatment Difference|-33.06|STANDARD_ERROR_OF_MEAN|2.06|<|0.0001|TWO_SIDED|95.0|-37.12|-28.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-28.99|-37.12|<0.0001
91528655|NCT01984424|182933092|SUPERIORITY||LS Mean Treatment Difference|-31.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-35.44|-16.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-16.76|-35.44|<0.0001
91493508|NCT03385564|182857991|OTHER||Difference|-2.86||||0.9275|TWO_SIDED|80.0|-28.58|21.1|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||21.10|-28.58|0.9275
91701009|NCT02634268|183296860|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.12|TWO_SIDED|95.0|-5.19|0.56|||Mixed Models Analysis|Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.56|-5.19|0.12
91759173|NCT04038567|183411372|SUPERIORITY||Mean Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-1.33|0.27||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.27|-1.33|
91493509|NCT03385564|182857991|OTHER||Difference|-10.0||||0.6064|TWO_SIDED|80.0|-29.9|10.64|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||10.64|-29.90|0.6064
91528656|NCT01984424|182933093|SUPERIORITY||LS Mean Treatment Difference|-33.86|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-38.15|-29.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.58|-38.15|<0.0001
91759174|NCT04038567|183411372|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.55|1.05||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.05|-.55|
91759175|NCT04038567|183411373|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.41|0.41||||||||0.41|-1.41|
91493510|NCT03385564|182857991|OTHER||Difference|0.0|||||TWO_SIDED|80.0|-18.37|18.07|||||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||18.07|-18.37|
91528657|NCT01984424|182933094|SUPERIORITY||LS Mean Treatment Difference|-31.75|STANDARD_ERROR_OF_MEAN|2.33|<|0.0001|TWO_SIDED|95.0|-36.35|-27.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.16|-36.35|<0.0001
91759176|NCT04038567|183411373|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.27|0.55||||||||0.55|-1.27|
91493511|NCT03385564|182857992|OTHER||Difference|3.73||||0.9119|TWO_SIDED|80.0|-20.53|29.6|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||29.60|-20.53|0.9119
91493512|NCT03385564|182857992|OTHER||Difference|3.73||||0.851|TWO_SIDED|80.0|-16.58|24.31|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||24.31|-16.58|0.8510
91493513|NCT03385564|182857992|OTHER||Difference|16.43||||0.3498|TWO_SIDED|80.0|-3.53|34.73|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||34.73|-3.53|0.3498
91528658|NCT01984424|182933095|SUPERIORITY||LS Mean Treatment Difference|-29.91|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-34.06|-25.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-25.77|-34.06|<0.0001
91528659|NCT01984424|182933096|SUPERIORITY||LS Mean Treatment Difference|-27.2|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|-31.58|-22.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-22.82|-31.58|<0.0001
91528660|NCT01984424|182933097|SUPERIORITY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001|TWO_SIDED|95.0|-38.59|-29.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.67|-38.59|<0.0001
91701010|NCT02634268|183296861|SUPERIORITY||Mean Difference (Final Values)|-2.72||||0.03|TWO_SIDED|95.0|-5.19|-0.25|||Mixed Models Analysis|Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.25|-5.19|0.03
91701011|NCT02634268|183296862|SUPERIORITY||Mean Difference (Final Values)|-2.42||||0.03|TWO_SIDED|95.0|-4.55|-0.28|||Mixed Models Analysis|Difference in average SGRQ-C Total score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.28|-4.55|0.03
91701012|NCT00628095|183296914|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0221||||0.591|TWO_SIDED|90.0|-0.17|0.13|||Normal Approximation method|No adjustments for multiple comparisons were performed.|Power of 80% and a Type I error at 0.10 in a 1-sided test was calculated. Null hypothesis stated that there was no difference between the CE-224,535 and placebo arm groups, on the percentage of ACR 20 responders at Week 12.|Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.13|-0.17|0.591
91701013|NCT00628095|183296915|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.1232||||0.941|TWO_SIDED|80.0|-0.22|-0.02|||Normal Approximation method|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||-0.02|-0.22|0.941
91701014|NCT00628095|183296915|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0622||||0.742|TWO_SIDED|80.0|-0.18|0.05|||Normal Approximation method|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.05|-0.18|0.742
91701015|NCT00628095|183296915|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.004||||0.482|TWO_SIDED|80.0|-0.11|0.12|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.12|-0.11|0.482
91701016|NCT00628095|183296916|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0072||||0.989|TWO_SIDED|80.0|-0.08|0.06|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.06|-0.08|0.989
91528661|NCT01984424|182933098|SUPERIORITY||LS Mean Treatment Difference|-31.98|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-36.64|-27.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.32|-36.64|<0.0001
91701017|NCT00628095|183296916|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0096||||0.957|TWO_SIDED|80.0|-0.08|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.08|0.957
91701018|NCT00628095|183296916|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0044||||0.473|TWO_SIDED|80.0|-0.08|0.09|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.09|-0.08|0.473
91701019|NCT00628095|183296916|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.057||||0.793|TWO_SIDED|80.0|-0.15|0.03|||Normal Approximation method|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.03|-0.15|0.793
91493514|NCT03385564|182857993|OTHER||Difference|5.43||||0.7921|TWO_SIDED|80.0|-10.19|23.57|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.57|-10.19|0.7921
91528662|NCT01984424|182933099|SUPERIORITY||LS Mean Treatment Difference|-21.08|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-27.65|-14.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.51|-27.65|<0.0001
91528663|NCT01984424|182933100|SUPERIORITY||LS Mean Treatment Difference|-21.24|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|TWO_SIDED|95.0|-28.42|-14.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.05|-28.42|<0.0001
91528664|NCT01984424|182933101|SUPERIORITY||LS Mean Treatment Difference|-4.44|STANDARD_ERROR_OF_MEAN|4.72||0.37|TWO_SIDED|95.0|-13.74|4.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||4.87|-13.74|0.37
91528665|NCT01984424|182933102|SUPERIORITY||LS Mean Treatment Difference|-1.82|STANDARD_ERROR_OF_MEAN|6.0||0.37|TWO_SIDED|95.0|-13.64|10.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.01|-13.64|0.37
91528666|NCT01984424|182933103|SUPERIORITY||LS Mean Treatment Difference|6.18|STANDARD_ERROR_OF_MEAN|2.05||0.0083|TWO_SIDED|95.0|2.15|10.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.22|2.15|0.0083
91528667|NCT01984424|182933104|SUPERIORITY||LS Mean Treatment Difference|4.5|STANDARD_ERROR_OF_MEAN|2.27||0.0083|TWO_SIDED|95.0|0.02|8.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||8.98|0.02|0.0083
91701020|NCT00628095|183296917|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
91701021|NCT00628095|183296917|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0141||||0.421|TWO_SIDED|80.0|-0.05|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.05|0.421
91701022|NCT00628095|183296917|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0566||||0.058|TWO_SIDED|80.0|0.01|0.12|||Barnard exact test|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.12|0.01|0.058
91701023|NCT00628095|183296917|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
91701024|NCT00628095|183296925|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 2: p-value was analyzed using Barnard Exact Test.||||1.0000
91701025|NCT00628095|183296925|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 4: p-value was analyzed using Barnard Exact Test.||||1.0000
91701026|NCT00628095|183296925|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 8: p-value was analyzed using Barnard Exact Test.||||1.0000
91701027|NCT00628095|183296925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 12: p-value was analyzed using Barnard Exact Test.||||0.0637
91701028|NCT00628095|183296925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 14: p-value was analyzed using Barnard Exact Test.||||0.0637
91701029|NCT01005888|183296936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Observed number of attacks.|ANOVA|||||||<0.0001
91701030|NCT01005888|183296936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Normalized number of attacks.|ANOVA|||||||<0.0001
91701031|NCT01005888|183296937|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 1.|Fisher Exact|||||||>0.999
91701032|NCT01005888|183296937|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 2.|Fisher Exact|||||||>0.999
91701033|NCT01005888|183296938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
91701034|NCT01005888|183296939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
91701035|NCT01005888|183296940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91701036|NCT01005888|183296941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91493515|NCT03385564|182857995|OTHER||Difference|32.0||||0.1016|TWO_SIDED|80.0|10.28|44.74|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||44.74|10.28|0.1016
91493516|NCT03385564|182857995|OTHER||Difference|-3.71||||0.8323|TWO_SIDED|80.0|-23.79|15.29|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||15.29|-23.79|0.8323
91493517|NCT03385564|182857995|OTHER||Difference|7.0||||0.6247|TWO_SIDED|80.0|-10.5|23.31|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.31|-10.50|0.6247
91493518|NCT01146834|182858000|SUPERIORITY||Risk Difference (RD)|-0.02||||0.9|TWO_SIDED|95.0|-0.32|0.28|||Chi-squared|||Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.||0.28|-0.32|0.90
91493519|NCT01146834|182858002|SUPERIORITY||Risk Difference (RD)|-0.25||||0.25|TWO_SIDED|95.0|-0.68|0.18|||Fisher Exact|||||0.18|-0.68|0.25
91493520|NCT00826943|182858044|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.03
91493521|NCT00826943|182858044|SUPERIORITY_OR_OTHER|||||||0.11||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.11
91493522|NCT00826943|182858044|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||.45
91493523|NCT00826943|182858045|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||The threshold for significance was p \< .05.|Wilcoxon (Mann-Whitney)|||||||.27
91493524|NCT00826943|182858045|SUPERIORITY_OR_OTHER|||||||0.8||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.8
91493525|NCT00826943|182858045|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.52
91493526|NCT00826943|182858046|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.14
91701037|NCT01005888|183296942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91493527|NCT00826943|182858046|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||.54
91493528|NCT00826943|182858046|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||.42
91493529|NCT03338998|182858068|SUPERIORITY||Geo-mean ratio|1.05||||0.585|TWO_SIDED|90.0|0.717|1.535|||ANCOVA|||||1.535|0.717|0.585
91493530|NCT03329573|182858075|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.059|||||TWO_SIDED|90.0|1.006|1.115||||||||1.115|1.006|
91493531|NCT03329573|182858076|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.947|1.047||||||||1.047|0.947|
91493532|NCT03329573|182858077|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.064|||||TWO_SIDED|90.0|1.01|1.12||||||||1.120|1.010|
91701038|NCT01005888|183296942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91493533|NCT03329573|182858078|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.949|1.044||||||||1.044|0.949|
91493534|NCT03329573|182858079|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.024|||||TWO_SIDED|90.0|0.952|1.101||||||||1.101|0.952|
91493535|NCT03329573|182858080|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.02|||||TWO_SIDED|90.0|0.968|1.074||||||||1.074|0.968|
91493536|NCT00650260|182858105|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher Exact|||||||0.027
91701039|NCT01005888|183296942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0||||Week 8 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0001
91701040|NCT01005888|183296942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0||||Week 12 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0028
91701041|NCT01005888|183296943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91701042|NCT01005888|183296943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91493537|NCT00650260|182858106|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 1 sided|||||||0.078
91493538|NCT00650260|182858109|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91513271|NCT02710630|182898022|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.27|STANDARD_DEVIATION|38.4|||TWO_SIDED|90.0|99.063|134.13|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||134.130|99.063|
91513272|NCT02710630|182898022|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|83.73|STANDARD_DEVIATION|62.8|||TWO_SIDED|90.0|66.033|106.163|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||106.163|66.033|
91513273|NCT02710630|182898022|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|68.77|STANDARD_DEVIATION|50.3|||TWO_SIDED|90.0|56.452|83.782|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||83.782|56.452|
91513274|NCT02710630|182898022|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.13|STANDARD_DEVIATION|49.6|||TWO_SIDED|90.0|88.616|129.51|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.510|88.616|
91493539|NCT05405309|182858111|OTHER||||||||||||||||||"The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was estimated after the first 5 patients were treated at Original DL1 (camonsertib 40mg daily and olaparib 100mg BID dosing 2 days per week, at 28 day cycles)~After the first 5 patients were treated, it was determined that this dosing strategy may not be appropriate for R/R CLL patients and reduced dosing frequency may be necessary to increase the safety of the combination therapy. The protocol and DLs were amended, and sought to enroll an additional 18 patients.~Before the enrollment of 18 additional participants and MTD determination, the study was terminated due to sponsor de-activation of all programs associated with camonsertib."|||
91493540|NCT04997304|182858153|OTHER|Test of paired differences||||||0.0019|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0019
91493541|NCT04997304|182858153|OTHER|Test of paired differences||||||0.002|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0020
91493542|NCT04997304|182858154|OTHER|Test of paired differences||||||0.0008|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0008
91493543|NCT04997304|182858154|OTHER|Test of paired differences||||||0.0003|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0003
91493544|NCT04997304|182858155|OTHER|Test of paired differences||||||0.04|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.04
91493545|NCT04997304|182858155|OTHER|Test of paired differences||||||0.0965|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0965
91493546|NCT05231954|182858161|SUPERIORITY||Odds Ratio (OR)|1.29||||0.006|TWO_SIDED|95.0|1.08|1.55||P-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.55|1.08|0.006
91493547|NCT05231954|182858161|SUPERIORITY||Odds Ratio (OR)|0.82||||0.081|TWO_SIDED|95.0|0.65|1.03||The p-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.03|0.65|0.081
91493548|NCT05231954|182858162|SUPERIORITY||Odds Ratio (OR)|1.44||||0.044|TWO_SIDED|95.0|1.01|2.05||The p-value is adjusted for multiple comparisons, and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.05|1.01|0.044
91493549|NCT05231954|182858162|SUPERIORITY||Odds Ratio (OR)|1.02||||0.919|TWO_SIDED|95.0|0.69|1.5||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.50|0.69|0.919
91493550|NCT04249583|182858175|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
91493551|NCT02370160|182858186|OTHER||||||||||||||||||In Phase I: There were 9 subjects treated on dose level 1 (60 µg/kg/dose). There were 6 subjects treated on Dose level 2 (80 µg/kg/dose). There were four DLT events happened in Phase I. One was treated on dose level 1 and the other three were treated on dose level 2. Therefore the MTD was dose level 1.|||
91493552|NCT04487730|182858193|SUPERIORITY||Mean Difference (Final Values)|0.4727||||0.6249|TWO_SIDED||||||Mixed Models Analysis|||Functional connectivity within the orbital prefrontal cortex (OFC; specifically between lateral and medial OFC), significantly changed over time.||||0.6249
91493553|NCT04487730|182858194|SUPERIORITY||Mean Difference (Final Values)|3.8176||||0.525|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.525
91493554|NCT04487730|182858195|SUPERIORITY||Mean Difference (Final Values)|0.6503||||0.844|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.844
91493555|NCT03291808|182858205|OTHER|||||||0.35|||||||Kruskal-Wallis|||||||.35
91493556|NCT02891850|182858235|EQUIVALENCE|The hypothesis was that there was no difference in the satisfactory clinical response rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|2.78||||0.0007|TWO_SIDED|95.0|1.526|5.06|||Mantel Haenszel|Stratified by PAH category at baseline||||5.060|1.526|0.0007
91493557|NCT02891850|182858236|EQUIVALENCE|The hypothesis was that there was no difference in the change of 6MWD in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|22.56||||0.0542|TWO_SIDED|95.0|5.03|40.1|||t-test, 2 sided|Stratified by PAH category at baseline||||40.10|5.03|0.0542
91493558|NCT02891850|182858237|EQUIVALENCE|The hypothesis was that there was no difference in the change of NT-proBNP in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-169.65||||0.1067|TWO_SIDED|95.0|-426.18|86.88|||t-test, 2 sided|Stratified by PAH category at baseline||||86.88|-426.18|0.1067
91493559|NCT02891850|182858238|EQUIVALENCE|The hypothesis was that there was no difference in the change from baseline in WHO FC in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-0.26||||0.0007|TWO_SIDED|95.0|-0.42|-0.11|||t-test, 2 sided|Stratified by PAH category at baseline||||-0.11|-0.42|0.0007
91493560|NCT02891850|182858239|EQUIVALENCE|The hypothesis was that there was no difference in the clinical worsening rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|0.1||||0.0047|TWO_SIDED|95.0|0.013|0.725|||Mantel Haenszel|Stratified by PAH category at baseline||||0.725|0.013|0.0047
91513275|NCT02710630|182898022|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.64|STANDARD_DEVIATION|38.9|||TWO_SIDED|90.0|91.625|124.114|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||124.114|91.625|
91701043|NCT01005888|183296943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 8 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91701044|NCT01005888|183296943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Week 12 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0002
91701045|NCT01043705|183296944|SUPERIORITY_OR_OTHER||One sided Fisher's exact test.|0.0044||||0.0023|ONE_SIDED|95.0||0.009|||Fisher Exact|||||0.009||0.0023
91701046|NCT01043705|183296944|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Text|0.002||||0.0052|ONE_SIDED|95.0||0.01|||Fisher Exact|||||0.01||0.0052
91731689|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0852|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0852
91731690|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0125
91731691|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0125
91731692|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.2714|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.2714
91731693|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR.||||0.1692
91731694|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.0772|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.0772
91731695|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.5762
91731696|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.5762
91701047|NCT01043705|183296944|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Test|0.006||||0.0176|ONE_SIDED|95.0||0.014|||Fisher Exact|||||0.014||0.0176
91701048|NCT01043705|183296944|SUPERIORITY_OR_OTHER||Fisher's Exact Test|0.7||||0.3764|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3764
91701049|NCT01043705|183296945|SUPERIORITY_OR_OTHER||Rate compared to performance goal|4.4||||0.0005|TWO_SIDED|95.0|3.3|5.8|||1-sided Chi-square|||||5.8|3.3|0.0005
91701050|NCT01043705|183296945|SUPERIORITY_OR_OTHER||Rate compared to a performance goal|3.1||||0.0444|TWO_SIDED|95.0|1.7|5.1|||1-sided Chi-square test|||||5.1|1.7|0.0444
91731697|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||1.0000
91701051|NCT01043705|183296945|SUPERIORITY_OR_OTHER||rate compared to performance goal|5.4||||0.0006|TWO_SIDED|95.0|3.8|5.4|||1-sided Chi-squared test|||All types of mechanical complications combined.||5.4|3.8|0.0006
91701052|NCT01043705|183296945|SUPERIORITY_OR_OTHER||Descriptive|5.4||||0.0745|TWO_SIDED|95.0|3.7|7.5|||Chi-squared|||All mechanical complications, retrospective, non-TYRX cohort||7.5|3.7|0.0745
91701053|NCT02635542|183296948|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
91701054|NCT02635542|183296949|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91701055|NCT02003963|183296951|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91701056|NCT01323010|183296975|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Chi-squared|||||||0.689
91701057|NCT01323010|183296976|SUPERIORITY_OR_OTHER|||||||0.591|TWO_SIDED||||||t-test, 2 sided|||||||0.591
91701058|NCT01323010|183296977|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.||||||0.150
91701059|NCT01323010|183296978|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
91731698|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
91731699|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.6862|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.6862
91528668|NCT01984424|182933105|SUPERIORITY||LS Mean Treatment Difference|-4.65|STANDARD_ERROR_OF_MEAN|3.85||0.37|TWO_SIDED|95.0|-12.25|2.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||2.94|-12.25|0.37
91528669|NCT01984424|182933106|SUPERIORITY||LS Mean Treatment Difference|-1.23|STANDARD_ERROR_OF_MEAN|4.67||0.37|TWO_SIDED|95.0|-10.45|7.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||7.98|-10.45|0.37
91528670|NCT01807221|182933110|OTHER||Mean Difference (Final Values)|-6.3||||0.8771|TWO_SIDED|90.0|-14.9|2.3|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||2.3|-14.9|0.8771
91528671|NCT01807221|182933110|OTHER||Mean Difference (Final Values)|-4.7||||0.7945|TWO_SIDED|90.0|-13.4|4.0|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||4|-13.4|0.7945
91528672|NCT01807221|182933110|OTHER||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED|90.0|-8.5|8.8|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||8.8|-8.5|0.5
91701060|NCT01323010|183296979|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANOVA|||||||0.108
91701061|NCT01323010|183296981|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||ANOVA|||||||0.122
91701062|NCT01323010|183296983|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.||||||0.164
91701063|NCT01323010|183296984|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||ANOVA|||||||0.165
91701064|NCT01323010|183296985|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED||||||ANOVA|||||||0.436
91528673|NCT01807221|182933110|OTHER||Mean Difference (Final Values)|1.6||||0.4225|TWO_SIDED|90.0|-7.1|10.2|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||10.2|-7.1|0.4225
91528674|NCT01807221|182933110|OTHER||Mean Difference (Final Values)|-3.0||||0.6865|TWO_SIDED|90.0|-11.7|5.7|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||5.7|-11.7|0.6865
91528675|NCT01087723|182933123|SUPERIORITY_OR_OTHER||Relative risk|0.6||||0.0014|TWO_SIDED|95.0|0.43|0.82|||Chi-squared|||||0.82|0.43|0.0014
91528676|NCT01649596|182933145|SUPERIORITY_OR_OTHER||percent|10.0||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
91528677|NCT01649596|182933146|SUPERIORITY_OR_OTHER||percent|48.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|A t-test for percents was used to compare the number of participants (%) from each group reporting satisfaction (somewhat and highly satisfied).||||||<0.05
91701065|NCT01323010|183296986|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||ANOVA|||||||0.046
91701066|NCT01323010|183296987|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED||||||ANOVA|||||||0.723
91701067|NCT01323010|183296988|SUPERIORITY_OR_OTHER|||||||0.235|TWO_SIDED||||||ANOVA|||||||0.235
91701068|NCT01323010|183296989|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||ANOVA|||||||0.284
91701069|NCT01323010|183296990|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANOVA|||||||0.905
91701070|NCT01323010|183296993|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.892
91701071|NCT01323010|183296994|SUPERIORITY_OR_OTHER|||||||0.195|TWO_SIDED||||||Chi-squared|||||||0.195
91701072|NCT01323010|183296995|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||Chi-squared, Corrected|||||||0.203
91701073|NCT01323010|183296996|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.03
91701074|NCT01203826|183297038|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|P-value based on Wilcoxon signed-rank test.||Change is relative to Baseline in Study ENB-006-09 (NCT00952484). The RGI-C score represents evaluations of skeletal X-rays at each post-treatment study timepoint in Study ENB-008-10 compared with pre-treatment X-rays from Study ENB-006-09, using an ordinal scale. Therefore, no Baseline data for RGI-C are available.||||0.0005
91701075|NCT01785849|183297043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.46|||<|0.001|TWO_SIDED|95.0|18.71|56.31|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||56.31|18.71|<0.001
91701076|NCT01785849|183297044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.08|||<|0.001|TWO_SIDED|95.0|11.47|42.48|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by screening PTH category, recent cinacalcet use within 8 weeks before randomization, and region.||||42.48|11.47|<0.001
91701077|NCT01785849|183297045|SUPERIORITY_OR_OTHER||Mean Difference|-71.11|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-77.77|-64.46|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-64.46|-77.77|<0.001
91493561|NCT02957305|182858240|NON_INFERIORITY|400µg of misoprostol yields a 96% cervical dilation \> 8 mm. We considered 86% of the 200 µg misoprostol group as the minimal acceptable percentage. The non-inferiority margin was determined by 24.46.|treatment difference|25.0||||0.025|ONE_SIDED|95.0||97.5||The null hypothesis: percentage of dilation with 400µg ≥ percentage of dilation with 200µg + 25% Alternative hypothesis: percentage of dilation with 400µg - 25% \< percentage of dilation with 200µg|difference between proportions|difference between percentages and 95% confidence interval||If there is a true difference in favour of the standard treatment of 10% (96% vs 86%), then 184 patients are required to be 95% sure that the upper limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 25%||97.5||0.025
91701078|NCT01785849|183297046|SUPERIORITY_OR_OTHER||Mean Difference|-8.38|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|-9.52|-7.23|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-7.23|-9.52|<0.001
91701079|NCT01785849|183297047|SUPERIORITY_OR_OTHER||Mean Difference|-14.99|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-19.73|-10.25|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.25|-19.73|<0.001
91701080|NCT01785849|183297048|SUPERIORITY_OR_OTHER||Mean Difference|-7.45|STANDARD_ERROR_OF_MEAN|2.47||0.003|TWO_SIDED|95.0|-12.31|-2.59|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-2.59|-12.31|0.003
91701081|NCT02880865|183297049|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||2.2|-2.1|
91701082|NCT02880865|183297050|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% CI for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||1.0|-0.3|
91701083|NCT02880865|183297051|NON_INFERIORITY|The percentage of participants with seropositivity for mumps at 56 days post-vaccination between Group 1 and Group 2 were compared using a non-inferiority test. Non-inferiority of Group 1 to Group 2 in terms of seropositivity for mumps was demonstrated if the lower limit of the two-sided 95% CI for the difference of seropositivity rates between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.1||||||||2.1|-2.0|
91701084|NCT02880865|183297052|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.2|||||Group 1/Group 2 ratio obtained using analysis of covariance (ANCOVA) with log10-transformed antibody concentration as dependent variable and treatment group as the explanatory variable adjusted for log10-transformed baseline antibody concentration.|||1.2|0.9|
91701085|NCT02880865|183297053|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Group 1/Group 2 ratio obtained using an ANCOVA method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody concentration.|||1.1|0.9|
91701086|NCT02880865|183297054|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2|||||Group 1 - Group 2|||2.2|-2.1|
91701087|NCT02880865|183297055|OTHER||Difference|1.6|||||TWO_SIDED|95.0|-1.8|4.9|||||Group 1 - Group 2|||4.9|-1.8|
91701088|NCT02880865|183297056|OTHER||Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0|||||Group 1 - Group 2|||1.0|-0.3|
91701089|NCT02880865|183297057|OTHER||Difference|4.1|||||TWO_SIDED|95.0|-3.1|11.3||||||||11.3|-3.1|
91701090|NCT02880865|183297058|OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|1.0|1.4|||||Group 1 / Group 2 ratio obtained using an analysis of covariance (ANCOVA) method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody titer.|||1.4|1.0|
91701091|NCT03379753|183297065|OTHER||U statistic|984.5||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
91701092|NCT04450407|183297102|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% CI (Confidence Interval) is below 0.4.|LS Mean Difference|0.17|||||TWO_SIDED|90.0|0.01|0.32||||||||0.32|0.01|
91528678|NCT01757665|182933150|SUPERIORITY||percent of patients|0.1|||||ONE_SIDED|95.0||0.7|||||Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.|The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.||0.7||
91528679|NCT00183456|182933183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.01|TWO_SIDED|95.0|0.13|0.63|||Generalized Estimating Equations|||||0.63|0.13|<0.01
91493562|NCT02957305|182858240|NON_INFERIORITY|The non-inferiority margin was determined by ⅓ of the difference between the 400µg effect (96.7%), compared to the 200 µg dose (23.3%), i.e. 73.4 / 3 = 24.46%|Difference between proportions|0.1146||||0.004|TWO_SIDED|95.0|0.037|0.192|||Chi-squared||The difference between both groups was 11.5% (95%CI = 3.7% to 19.2%)|||0.192|0.037|0.004
91493563|NCT02957305|182858242|SUPERIORITY||Median Difference (Final Values)|0.0||||0.9|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.9
91493564|NCT01509950|182858297|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
91493565|NCT02820753|182858318|SUPERIORITY||Mean Difference (Net)|0.26||||0.04|TWO_SIDED|95.0|0.01|0.51||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment difference = (Text or Portal) - Enhanced Usual Care|||0.51|0.01|0.04
91493566|NCT02820753|182858319|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.15||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment Difference = (Text or Portal - Enhanced Usual Care|||0.15|-0.08|0.53
91493567|NCT02820753|182858320|SUPERIORITY||Mean Difference (Net)|-0.34||||0.41|TWO_SIDED|95.0|-1.16|0.48||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.48|-1.16|0.41
91528680|NCT00183456|182933184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.05|TWO_SIDED|95.0|1.22|5.89|||Generalized Estimating Equations|||||5.89|1.22|0.05
91528681|NCT00183456|182933185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.05|TWO_SIDED|95.0|0.16|0.84|||Generalized Estimating Equations|||||0.84|0.16|0.05
91528682|NCT00183456|182933186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82||||0.01|TWO_SIDED|95.0|1.41|5.64|||Generalized Estimating Equations|||||5.64|1.41|0.01
91528683|NCT00183456|182933187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.01|TWO_SIDED|95.0|0.09|0.68|||Generalized Estimating Equations|||||0.68|0.09|0.01
91701093|NCT00715104|183297113|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|16.2||||1|TWO_SIDED|95.0|1.7|30.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||30.7|1.7|1.000
91528684|NCT00183456|182933188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.05|TWO_SIDED|95.0|0.25|0.87|||Generalized Estimating Equations|||||0.87|0.25|0.05
91528685|NCT00183456|182933189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.01|TWO_SIDED|95.0|0.21|0.77|||Generalized Estimating Equations|||||0.77|0.21|0.01
91493568|NCT02820753|182858321|SUPERIORITY||Mean Difference (Net)|1.83||||0.27|TWO_SIDED|95.0|-1.39|5.06||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment difference = (Text or Portal ) - Enhanced Usual Care|||5.06|-1.39|0.27
91493569|NCT02820753|182858322|SUPERIORITY||Mean Difference (Net)|-0.23||||0.33|TWO_SIDED|95.0|-0.68|0.23||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.23|-0.68|0.33
91493570|NCT01652703|182858323|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.61|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-74.51|-62.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-62.71|-74.51|<0.001
91528686|NCT00183456|182933190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.05|TWO_SIDED|95.0|0.14|0.79|||Generalized Estimating Equations|||||0.79|0.14|0.05
91528687|NCT00183456|182933191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.01|TWO_SIDED|95.0|0.14|0.64|||Generalized Estimating Equations|||||0.64|0.14|0.01
91528688|NCT00183456|182933192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.01|TWO_SIDED|95.0|1.25|4.65|||Generalized Estimating Equations|||||4.65|1.25|0.01
91528689|NCT00981825|182933210|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91528690|NCT01263106|182933344|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.05|1.2|||Mixed Models Analysis|||||1.20|1.05|
91528691|NCT01263106|182933345|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|||||1.01|0.92|
91528692|NCT01263106|182933346|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8008|TWO_SIDED|90.0|-3.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-3.00|0.8008
91528693|NCT05027074|182933368|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.47|TWO_SIDED|95.0|0.6|1.26||From log-rank test stratified by region (US, Non-US), previous thrombosis of active AVG (yes, no) and regular aspirin use up to 150 mg daily at baseline (yes, no).|Log Rank||HR based on stratified Cox model with Efron's method of tie handling and with a single treatment covariate, controlling for stratification factors of region, previous thrombosis of active AVG and regular aspirin use up to 150 mg daily at baseline.|||1.26|0.60|0.470
91528694|NCT05027074|182933368|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.57|1.19|||||HR based on stratified Cox model with Efron's method of tie handling and with a single treatment covariate, controlling for stratification factors of region, previous thrombosis of active AVG and regular aspirin use up to 150 mg daily at baseline.|||1.19|0.57|
91528695|NCT05027074|182933369|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.68|1.21|||||HR based on Andersen-Gill model with stratification factors of region, previous thrombosis of active AVG, and regular aspirin use up to 150 mg daily at baseline as fixed effect.|||1.21|0.68|
91493571|NCT01652703|182858323|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.85|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-58.84|-46.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-46.86|-58.84|<0.001
91493572|NCT01652703|182858323|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.94|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-70.23|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-57.66|-70.23|<0.001
91493573|NCT01652703|182858323|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.16|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-64.51|-51.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.81|-64.51|<0.001
91493574|NCT01652703|182858324|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-96.3|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-106.0|-86.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-86.5|-106.0|<0.001
91493575|NCT01652703|182858324|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-75.5|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-85.4|-65.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-65.5|-85.4|<0.001
91493576|NCT01652703|182858324|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-88.2|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-97.4|-79.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-79.0|-97.4|<0.001
91493577|NCT01652703|182858324|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-80.7|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-90.0|-71.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-71.4|-90.0|<0.001
91493578|NCT01652703|182858325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1945.68|||<|0.001|TWO_SIDED|95.0|89.64|42232.63||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||42232.63|89.64|<0.001
91493579|NCT01652703|182858325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|281.13|||<|0.001|TWO_SIDED|95.0|14.74|5360.92||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||5360.92|14.74|<0.001
91493580|NCT01652703|182858325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|536.45|||<|0.001|TWO_SIDED|95.0|28.37|10143.4||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||10143.40|28.37|<0.001
91493581|NCT01652703|182858325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|595.59|||<|0.001|TWO_SIDED|95.0|31.11|11402.67||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||11402.67|31.11|<0.001
91493582|NCT01652703|182858326|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.56|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-67.85|-57.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-57.27|-67.85|<0.001
91493583|NCT01652703|182858326|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.46|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-54.83|-44.08||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-44.08|-54.83|<0.001
91493584|NCT01652703|182858326|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.08|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.93|-52.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-52.22|-63.93|<0.001
91493585|NCT01652703|182858326|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.54|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-59.46|-47.63||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.63|-59.46|<0.001
91493586|NCT01652703|182858327|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.69|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-65.67|-55.72||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.72|-65.67|<0.001
91493587|NCT01652703|182858327|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.75|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-51.8|-41.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.70|-51.80|<0.001
91493588|NCT01652703|182858327|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-58.91|-47.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.97|-58.91|<0.001
91528696|NCT05027074|182933369|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.7|1.23|||||HR based on Andersen-Gill model with stratification factors of region, previous thrombosis of active AVG, and regular aspirin use up to 150 mg daily at baseline as fixed effect.|||1.23|0.70|
91731700|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0563
91493589|NCT01652703|182858327|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.37|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-52.9|-41.85||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.85|-52.90|<0.001
91731701|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0563
91731702|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||0.1692
91731703|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR?||||||0.1822|||||||t|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR.||||0.1822
91731704|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0220
91731705|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0220
91731706|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR.||||0.0220
91731707|NCT02732145|183357815|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
91731708|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of hyperkeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperkeratosis in vulvar specimens of patients from different groups.||||0.0000
91731709|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of parakeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of parakeratosis in vulvar specimens of patients from different groups.||||0.0000
91493590|NCT01652703|182858328|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-34.49|STANDARD_ERROR_OF_MEAN|11.75||0.004|TWO_SIDED|95.0|-57.71|-11.26||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.26|-57.71|0.004
91493591|NCT01652703|182858328|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.25|STANDARD_ERROR_OF_MEAN|11.93||0.044|TWO_SIDED|95.0|-47.83|-0.68||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-0.68|-47.83|0.044
91731710|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of acanthosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of acanthosis in vulvar specimens of patients from different groups.||||0.0000
91731711|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of epidermal atrophy in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of epidermal atrophy in vulvar specimens of patients from different groups.||||0.0000
91731712|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
91731713|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
91731714|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of lymphocytes in vulvar specimens of patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes (infiltrates) in vulvar specimens of patients from different groups.||||0.0105
91701094|NCT00715104|183297113|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|18.9||||1|TWO_SIDED|95.0|3.5|34.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||34.3|3.5|1.000
91701095|NCT00715104|183297113|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|70.3|||<|0.001|TWO_SIDED|95.0|52.3|88.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||88.3|52.3|<0.001
91701096|NCT00715104|183297114|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|20.6||||1|TWO_SIDED|95.0|4.0|37.2||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||37.2|4.0|1.000
91701097|NCT00715104|183297114|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|32.4||||0.014|TWO_SIDED|95.0|13.1|51.6||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||51.6|13.1|0.014
91493592|NCT01652703|182858328|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.82|STANDARD_ERROR_OF_MEAN|9.36||0.002|TWO_SIDED|95.0|-48.32|-11.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.32|-48.32|0.002
91701098|NCT00715104|183297114|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|79.4|||<|0.001|TWO_SIDED|95.0|62.8|96.0||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||96.0|62.8|<0.001
91705513|NCT01080391|183305556|SUPERIORITY|The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).|Hazard Ratio (HR)|0.794||||0.0045|TWO_SIDED|95.0|0.667|0.945|||Log Rank|Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).||The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).||0.945|0.667|0.0045
91731715|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of mastocytes in vulvar specimens of patients from different groups?||||||0.0064|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mastocytes in vulvar specimens of patients from different groups.||||0.0064
91731716|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of collagen fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens of patients from different groups.||||0.0000
91731717|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of hyalinization in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens of patients from different groups.||||0.0000
91731718|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of hyperpigmentation in vulvar specimens of patients from different groups?||||||0.0342|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperpigmentation in vulvar specimens of patients from different groups.||||0.0342
91493593|NCT01652703|182858328|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.82|STANDARD_ERROR_OF_MEAN|9.41||0.028|TWO_SIDED|95.0|-39.41|-2.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-2.22|-39.41|0.028
91493594|NCT01652703|182858329|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.98|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-52.21|-41.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.76|-52.21|<0.001
91493595|NCT01652703|182858329|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.22|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-42.52|-31.91||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-31.91|-42.52|<0.001
91493596|NCT01652703|182858329|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.66|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.32|-41.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.00|-52.32|<0.001
91731719|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of elongated dermal papillae in vulvar specimens of patients from different groups?||||||0.0148|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of elongated dermal papillae in vulvar specimens of patients from different groups.||||0.0148
91731720|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of blood vessels in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens of patients from different groups.||||0.0000
91731721|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens of patients from different groups.||||0.0000
91731722|NCT02732145|183357816|EQUIVALENCE|Question: Is there a difference in the incidence of nerve fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens of patients from different groups.||||0.0000
91731723|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0000
91731724|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||1|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||1.0000
91731725|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.3533|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.3533
91731726|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.5641|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.5641
91731727|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9684|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9684
91731728|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8599|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8599
91731729|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
91731730|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8389|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8389
91731731|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.7617|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.7617
91493597|NCT01652703|182858329|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.3|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.02|-39.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-39.58|-51.02|<0.001
91731732|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of the sharp pain of the vulva depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.4613|||||||Chi-squared|||Parameter: The difference in the incidence of the sharp (fast) pain of the vulva (knife-like pain, paper-cuts pain, stabbing, sticking) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.4613
91731733|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.0331|||||||Chi-squared, Corrected|||Parameter: The incidence of the vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0331
91731734|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of the vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
91731735|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9139|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9139
91731736|NCT02732145|183357817|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8925|||||||Chi-squared|||Parameter: The incidence of the vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8925
91731737|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0000
91731738|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6921|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6921
91493598|NCT01652703|182858330|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.35|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-67.14|-55.56||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.56|-67.14|<0.001
91493599|NCT01652703|182858330|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.53|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-53.41|-41.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.65|-53.41|<0.001
91493600|NCT01652703|182858330|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-63.73|-51.77||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-51.77|-63.73|<0.001
91493601|NCT01652703|182858330|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.22|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-58.27|-46.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-46.18|-58.27|<0.001
91731739|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.1848|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.1848
91731740|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.9048|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.9048
91731741|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3953|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3953
91493602|NCT02728050|182858343|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"Participants on study receiving CLAGM-S were compared to a historical cohort of newly diagnosed AML/high-risk MDS patients treated with CLAG-M alone, matched for mitoxantrone dose, age, and TRM score.~Number of participants in historical cohort = 71. Number of participants in historical cohort who achieved MRD-negative CR = 55 (77.46%)"||||0.48
91493603|NCT02577510|182858363|OTHER|||||||0.05|||||||t-test, 1 sided|||Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon's signed ranks or McNemar's test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant||||0.05
91701099|NCT00715104|183297115|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|35.1||||0.002|TWO_SIDED|95.0|16.3|53.9||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||53.9|16.3|0.002
91493604|NCT00777608|182858407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.231|TWO_SIDED|90.0|-0.2|0.08|||ANOVA|||||0.08|-0.2|0.231
91493605|NCT00777608|182858408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|90.0|-0.3|-0.008|||ANOVA||Statistical analysis for Week 2|||-0.008|-0.3|0.041
91701100|NCT00715104|183297115|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|29.7||||0.036|TWO_SIDED|95.0|11.7|47.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||47.7|11.7|0.036
91701101|NCT00715104|183297115|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|83.8|||<|0.001|TWO_SIDED|95.0|69.3|98.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||98.3|69.3|<0.001
91701102|NCT00715104|183297116|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||<0.001
91701103|NCT00715104|183297117|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.||||0.173
91701104|NCT00715104|183297118|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.667
91701105|NCT00715104|183297118|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.191
91701106|NCT00715104|183297118|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.699
91493606|NCT00777608|182858408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.143|TWO_SIDED|90.0|-0.3|0.06|||ANOVA||Statistical analysis for Week 8|||0.06|-0.3|0.143
91731742|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0921|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0921
91731743|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6734|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6734
91731744|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3458|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3458
91731745|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.5304|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.5304
91493607|NCT00777608|182858408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.226|TWO_SIDED|90.0|-0.2|0.09|||ANOVA||Statistical analysis for Week 12|||0.09|-0.2|0.226
91731746|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the sharp pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0012|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp (fast) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0012
91731747|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0002|||||||Chi-squared|||Parameter: The incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0002
91493608|NCT00777608|182858409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.324|TWO_SIDED|90.0|-1.2|2.2|||ANOVA||Statistical analysis for Week 4|||2.2|-1.2|0.324
91493609|NCT00777608|182858409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.4||0.285|TWO_SIDED|90.0|-1.5|3.1|||ANOVA|||||3.1|-1.5|0.285
91493610|NCT00777608|182858409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.401|TWO_SIDED|90.0|-2.6|1.9|||ANOVA||Statistical analysis for Week 12|||1.9|-2.6|0.401
91493611|NCT02621060|182858439|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.0||0.004|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
91493612|NCT02621060|182858440|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
91493613|NCT02621060|182858441|SUPERIORITY_OR_OTHER|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||||||0.755
91493614|NCT02621060|182858442|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91493615|NCT02621060|182858443|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
91493616|NCT02621060|182858444|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91731748|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0218|||||||Chi-squared, Corrected|||Parameter: The incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0218
91731749|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0297|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0297
91731750|NCT02732145|183357818|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6468
91701107|NCT00715104|183297119|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.086
91701108|NCT00715104|183297119|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.432
91731751|NCT02732145|183357819|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.2045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.2045
91731752|NCT02732145|183357819|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.7469|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.7469
91731753|NCT02732145|183357819|SUPERIORITY|Question: Is there a difference in the incidence of the finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.4271|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.4271
91731754|NCT02732145|183357819|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.3607|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.3607
91731755|NCT02732145|183357819|SUPERIORITY|Question: Is there a difference in the incidence of the finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.8672
91731756|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0045
91731757|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0032
91731758|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.1067|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.1067
91493617|NCT02621060|182858446|SUPERIORITY_OR_OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
91731759|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of inflammatory cells in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8672
91493618|NCT02621060|182858447|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
91493619|NCT02621060|182858448|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
91493620|NCT02621060|182858449|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|5.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
91731760|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0219|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0219
91731761|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8213|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8213
91731762|NCT02732145|183357820|SUPERIORITY|Question: Is there a difference in the incidence of the finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0613|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0613
91493621|NCT02621060|182858450|SUPERIORITY_OR_OTHER|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
91493622|NCT02621060|182858451|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91731763|NCT04204902|183357829|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|91.15|||||TWO_SIDED|90.0|83.21|99.84||||||||99.84|83.21|
91731764|NCT04204902|183357830|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least square Mean|90.92|||||TWO_SIDED|90.0|82.99|99.61||||||||99.61|82.99|
91731765|NCT04204902|183357831|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|104.62|||||TWO_SIDED|90.0|95.17|115.0||||||||115.00|95.17|
91731766|NCT03715829|183357843|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.62|<|0.0001|TWO_SIDED|90.0|-32.53|-13.96||Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.96|-32.53|<0.0001
91731767|NCT03715829|183357843|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.63|<|0.0001|TWO_SIDED|90.0|-32.53|-13.93||Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.93|-32.53|<0.0001
91731768|NCT03715829|183357843|SUPERIORITY||Least Squares Mean Difference (Net)|-20.6|STANDARD_ERROR_OF_MEAN|5.84||0.0003|TWO_SIDED|90.0|-30.23|-10.93||Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-10.93|-30.23|0.0003
91731769|NCT03715829|183357843|SUPERIORITY||Least Squares Mean Difference (Net)|-16.7|STANDARD_ERROR_OF_MEAN|6.71||0.0068|TWO_SIDED|90.0|-27.77|-5.61||Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||-5.61|-27.77|0.0068
91731770|NCT03715829|183357843|SUPERIORITY||Least Squares Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|6.03||0.2015|TWO_SIDED|90.0|-15.02|4.91||Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||4.91|-15.02|0.2015
91731771|NCT05273437|183357876|OTHER|We conducted a Bayesian Regression for all available participants, then visualized the results. (N x 16 table, N: number of participants).|Credibility interval|80.0|||||TWO_SIDED||||||Bayesian Regression|We explicitly sought 80% credibility of at least 100 steps more within the 3-hour increment in comparison to the intervention.|We decided that 100 steps/3 hours is the minimum value of the MAP intervention effect estimate and that an INUS condition is valid only if there is at least an 80% chance of achieving an effect beyond 100 steps/3 hours.|We hypothesized that some individuals have their own time and decision-policy-specific response pattern regardless of day elapsed since the beginning of the intervention. We did not hypothesize the direction of the effect variation.|The decision point was the unit of analysis. For the Bayesian Regression, we used Markov Chain Monte Carlo (MCMC). Four sampling chains were used when performing Bayesian modeling. The number of estimation samples and target acceptance rate were gradually increased until numerical stability was achieved. The number of estimation samples was increased by multiplied by 2, as advised by previous literature, depending on the ratio of convergence diagnostics R̂ \> 1.1. We used 100 steps increase during 3 hours as the effect threshold value. We assumed that there is an effect only if the estimated effect is more than 80% probable (i.e., the credibility interval is over 100 steps/3 hours) and the Maximum A Posteriori Point (MAP) of the effect is more than 100 steps/3 hours. Otherwise, there is no effect. Among the models with effects, we clipped to 1000 steps/3hours as a maximum if the MAP was greater than 1000 steps/3 hours.|||
91493623|NCT02621060|182858452|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91493624|NCT02621060|182858453|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91493625|NCT02621060|182858454|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
91493626|NCT02621060|182858455|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
91493627|NCT02621060|182858456|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91731772|NCT03647137|183357877|OTHER||Standardized β Coefficient|-2.256||||0.00468|TWO_SIDED|||||The p-value is derived from model comparison between the FEOVB model and the FEOVB\*PIB interaction model.|ChiSq Goodness of Fit Test|||L-DOPA sensitivity outcome measure was modeled with 3-level hierarchical ordinal logistic regression. The null model contained only striatal DTBZ as predictor of group, the FEOVB model additionally had FEOVB tracer, and interaction model had in addition an interaction term between FEOVB and PIB tracer. Model comparisons were performed using Chi-Square goodness of fit test.||||0.00468
91731773|NCT03900650|183357899|OTHER||Mean Difference (Final Values)|7.32|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
91731774|NCT03900650|183357900|OTHER||Mean Difference (Final Values)|0.377||||0.77|TWO_SIDED|||||This p-value tests the effect of the study arms on number of sex events.|ANOVA|||||||.770
91731775|NCT00829868|183357901|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|109.0||||||90.0|99.3|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|99.3|
91493628|NCT02621060|182858457|SUPERIORITY_OR_OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
91493629|NCT02621060|182858458|SUPERIORITY_OR_OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||||||0.472
91493630|NCT02621060|182858459|SUPERIORITY_OR_OTHER|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
91493631|NCT02621060|182858460|SUPERIORITY_OR_OTHER|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||||||0.637
91493632|NCT03087643|182858529|OTHER|||||||0.0492|||||||Mixed Models Analysis|||||||0.0492
91528697|NCT05027074|182933371|OTHER||Hazard Ratio (HR)|1.68||||0.022|TWO_SIDED|95.0|1.07|2.62||From log-rank test stratified by region (US, Non-US), previous thrombosis of active AVG (yes, no) and regular aspirin use up to 150 mg daily at baseline (yes, no).|Log Rank||HR based on stratified Cox model with Efron's method of tie handling and with a single treatment covariate, controlling for stratification factors of region, previous thrombosis of active AVG and regular aspirin use up to 150 mg daily at baseline.|||2.62|1.07|0.022
91701109|NCT00715104|183297119|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.249
91701110|NCT00715104|183297120|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.950
91701111|NCT00715104|183297121|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.048
91701112|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Week 12||||0.101
91701113|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.139|||||||Paired t-test|||Statistical analysis at Week 24||||0.139
91701114|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Week 36||||0.116
91701115|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.167|||||||Paired t-test|||Statistical analysis at Week 48||||0.167
91701116|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.21|||||||Paired t-test|||Statistical analysis at Week 56||||0.210
91701117|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.343|||||||Paired t-test|||Statistical analysis at Week 68||||0.343
91701118|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.533|||||||Paired t-test|||Statistical analysis at Week 80||||0.533
91731776|NCT00829868|183357902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|101.0||||||90.0|97.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|97.5|
91701119|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.593|||||||Paired t-test|||Statistical analysis at Week 92||||0.593
91701120|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.044|||||||Paired t-test|||Statistical analysis at Week 104||||0.044
91701121|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.243|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.243
91701122|NCT01668966|183297156|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.009
91701123|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.1853|||||||Paired t-test|||Statistical analysis at Week 12||||0.1853
91701124|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.2992|||||||Paired t-test|||Statistical analysis at Week 24||||0.2992
91731777|NCT00829868|183357903|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|100.0||||||90.0|96.2|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.2|
91701125|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.2249|||||||Paired t-test|||Statistical analysis at Week 36||||0.2249
91701126|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.3102|||||||Paired t-test|||Statistical analysis at Week 48||||0.3102
91701127|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.2164|||||||Paired t-test|||Statistical analysis at Week 56||||0.2164
91701128|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.8822|||||||Paired t-test|||Statistical analysis at Week 68||||0.8822
91701129|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.7649|||||||Paired t-test|||Statistical analysis at Week 80||||0.7649
91701130|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.605|||||||Paired t-test|||Statistical analysis at Week 92||||0.6050
91701131|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.4478|||||||Paired t-test|||Statistical analysis at Week 104||||0.4478
91701132|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.4821|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4821
91701133|NCT01668966|183297157|SUPERIORITY_OR_OTHER|||||||0.0522|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0522
91701134|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Week 12||||0.0624
91701135|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.0616|||||||Paired t-test|||Statistical analysis at Week 24||||0.0616
91701136|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.248|||||||Paired t-test|||Statistical analysis at Week 36||||0.2480
91701137|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.5393|||||||Paired t-test|||Statistical analysis at Week 48||||0.5393
91701138|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.1401|||||||Paired t-test|||Statistical analysis at Week 56||||0.1401
91701139|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.0679|||||||Paired t-test|||Statistical analysis at Week 68||||0.0679
91701140|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Paired t-test|||Statistical analysis at Week 80||||0.6017
91701141|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.4772|||||||Paired t-test|||Statistical analysis at Week 92||||0.4772
91731778|NCT01603368|183357921|OTHER|Student's t-test|||||=|0.001|||||||t-test, 2 sided|||||||=0.001
91731779|NCT01554904|183357925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.24|STANDARD_ERROR_OF_MEAN|62.4||0.02|TWO_SIDED|95.0|27.32|297.16|||paired t test|||The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.||297.16|27.32|0.02
91731780|NCT01554904|183357926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.22|TWO_SIDED|95.0|-2.28|0.584||paired t test|t-test, 2 sided|||Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.||0.584|-2.28|0.22
91701142|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.4877|||||||Paired t-test|||Statistical analysis at Week 104||||0.4877
91731781|NCT00967486|183357961|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
91493633|NCT03087643|182858530|OTHER|||||||0.0283|||||||Mixed Models Analysis|||||||0.0283
91493634|NCT03087643|182858531|OTHER|||||||0.0321|||||||Mixed Models Analysis|||||||0.0321
91701143|NCT01668966|183297158|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.0624
91701144|NCT01668966|183297158|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||<0.0001
91701145|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.2388|||||||Paired t-test|||Statistical analysis at Week 12||||0.2388
91701146|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.1084|||||||Paired t-test|||Statistical analysis at Week 24||||0.1084
91701147|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Paired t-test|||Statistical analysis at Week 36||||0.0321
91731782|NCT01469156|183357962|OTHER|Visually significant ocular or systemic AEs were predominantly mild or moderate. No significant safety signals were observed in either group.High- and standard-dose ranibizumab were generally well tolerated without evidence of ocular or systemic severe adverse events, including arterial thromboembolic events.|data survey|28.0||||0.05|TWO_SIDED|95.0|0.0|28.0||28 ocular and non-ocular adverse events collected, in mild to moderate nature|t-test, 2 sided|||Purpose was to determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment of active PCV.|Visually significant ocular or systemic AEs that were either reported by subjects or identified by imaging and/or ocular exam|28|0|0.05
91731783|NCT03773562|183357985|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Responders vs Non-responders||||0.04
91493635|NCT03087643|182858532|OTHER|||||||0.0451|||||||Mixed Models Analysis|||||||0.0451
91493636|NCT03087643|182858533|OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
91493637|NCT02083783|182858534|SUPERIORITY||Mean Difference (Final Values)|-14.68|||<|0.0001|TWO_SIDED|95.0|-17.9|11.6|||ANCOVA|||Treatment difference in SKAMP-C scores from baseline to 4 hours postdose.||11.6|-17.9|<0.0001
91493638|NCT02083783|182858535|SUPERIORITY||Mean Difference (Final Values)|38.9|||<|0.0001|TWO_SIDED|95.0|27.3|50.6|||ANCOVA|||p-value for comparison between change from baseline in placebo vs active treatment||50.6|27.3|<0.0001
91493639|NCT02168361|182858553|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Null hypothesis is no difference between two regimens in SVR-12.||||.02
91493640|NCT00668707|182858600|SUPERIORITY||Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic|||Analysis conducted was an adjusted logistic regression (adjuvant chemotherapy, adjuvant radiation, smoking history). Results were presented as a relative risk. Based on an estimated 30% outcome rate of recurrence or mortality in the control arm, 294 participants per arm provided 80% power to detect a relative risk of one third at an alpha of 0.05. We inflated this sample size to 346 per arm to account for 15% lost to follow-up.||1.22|0.83|0.94
91701148|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Paired t-test|||Statistical analysis at Week 48||||0.0203
91701149|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.0193|||||||Paired t-test|||Statistical analysis at Week 56||||0.0193
91701150|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.6235|||||||Paired t-test|||Statistical analysis at Week 68||||0.6235
91701151|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.2814|||||||Paired t-test|||Statistical analysis at Week 80||||0.2814
91701152|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.3391|||||||Paired t-test|||Statistical analysis at Week 92||||0.3391
91701153|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.1605|||||||Paired t-test|||Statistical analysis at Week 104||||0.1605
91701154|NCT01668966|183297159|SUPERIORITY_OR_OTHER|||||||0.4312|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.4312
91701155|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.934|||||||Paired t-test|||Statistical analysis at Week 12||||0.934
91701156|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.624|||||||Paired t-test|||Statistical analysis at Week 24||||0.624
91701157|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.642|||||||Paired t-test|||Statistical analysis at Week 36||||0.642
91701158|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.952|||||||Paired t-test|||Statistical analysis at Week 48||||0.952
91701159|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.928|||||||Paired t-test|||Statistical analysis at Week 56||||0.928
91701160|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.832|||||||Paired t-test|||Statistical analysis at Week 68||||0.832
91701161|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.315|||||||Paired t-test|||Statistical analysis at Week 80||||0.315
91701162|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.485|||||||Paired t-test|||Statistical analysis at Week 92||||0.485
91701163|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 104||||0.246
91701164|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.375|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.375
91701165|NCT01668966|183297162|SUPERIORITY_OR_OTHER|||||||0.185|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.185
91701166|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.445|||||||Paired t-test|||Statistical analysis at Week 12||||0.445
91731784|NCT03773562|183357987|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.002
91731785|NCT03773562|183357988|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Responders vs Non-responders||||0.01
91731786|NCT03773562|183357990|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
91731787|NCT03773562|183357991|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
91731788|NCT03773562|183357992|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
91731789|NCT03773562|183357993|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||Responder vs non-responder||||0.0033
91493641|NCT00668707|182858601|SUPERIORITY||Mean Difference (Net)|1.2||||0.36|TWO_SIDED|95.0|-1.3|3.7|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Analysis for the LC-13 scale.||3.7|-1.3|0.36
91701167|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.414|||||||Paired t-test|||Statistical analysis at Week 24||||0.414
91493642|NCT00668707|182858601|SUPERIORITY||Mean Difference (Net)|0.4||||0.8|TWO_SIDED|95.0|-2.5|3.3||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Symptom Scale.||3.3|-2.5|0.80
91528698|NCT05027074|182933371|OTHER||Hazard Ratio (HR)|1.27||||0.311|TWO_SIDED|95.0|0.8|2.0||From log-rank test stratified by region (US, Non-US), previous thrombosis of active AVG (yes, no) and regular aspirin use up to 150 mg daily at baseline (yes, no).|Log Rank||HR based on stratified Cox model with Efron's method of tie handling and with a single treatment covariate, controlling for stratification factors of region, previous thrombosis of active AVG and regular aspirin use up to 150 mg daily at baseline.|||2.00|0.800|0.311
91701168|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.401|||||||Paired t-test|||Statistical analysis at Week 36||||0.401
91701169|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.92|||||||Paired t-test|||Statistical analysis at Week 48||||0.920
91701170|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.834|||||||Paired t-test|||Statistical analysis at Week 56||||0.834
91701171|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.539|||||||Paired t-test|||Statistical analysis at Week 68||||0.539
91701172|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 80||||0.246
91701173|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.602|||||||Paired t-test|||Statistical analysis at Week 92||||0.602
91701174|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.218|||||||Paired t-test|||Statistical analysis at Week 104||||0.218
91701175|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.208|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.208
91701176|NCT01668966|183297163|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.101
91701177|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.565|||||||Paired t-test|||Statistical analysis at Week 12||||0.565
91701178|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.637|||||||Paired t-test|||Statistical analysis at Week 24||||0.637
91731790|NCT03773562|183357994|SUPERIORITY|||||||0.0041|||||||t-test, 2 sided|||Responder vs non-responder||||0.0041
91731791|NCT03773562|183357995|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Responder vs non-responder||||0.0046
91731792|NCT01854762|183358037|OTHER||Odds Ratio (OR)|3.1|||<|0.01|TWO_SIDED|95.0|1.3|7.4|||Fisher Exact||||Kaplan-Meier estimates for the proportion of patients without virological failure by weeks 2, 4 and 6, and at delivery, using treatment-related discontinuation equal failure analysis|7.4|1.3|<0.01
91731793|NCT05078112|183358040|OTHER|||||||0.000393|||||||t-test, 2 sided|||||||0.000393
91731794|NCT03996395|183358048|OTHER||Descriptive statistic|71.0|STANDARD_DEVIATION|23.0|||TWO_SIDED|||||||||||||
91731795|NCT03555994|183358071|SUPERIORITY||Least square mean difference|-105.7||||0.023||90.0|-178.8|-32.6|||ANCOVA|||||-32.6|-178.8|0.023
91731796|NCT03555994|183358072|SUPERIORITY||Least square mean difference|-25.87||||0.008||90.0|-40.88|-10.86|||ANCOVA|||||-10.86|-40.88|0.008
91731797|NCT03555994|183358073|SUPERIORITY||Least Square Mean difference|-21.99||||0.008||90.0|-34.55|-9.43|||ANCOVA|||||-9.43|-34.55|0.008
91731798|NCT03555994|183358074|SUPERIORITY||Least Square Mean difference|-35.06||||0.07||90.0|-66.54|-3.58|||ANCOVA|||||-3.58|-66.54|0.070
91731799|NCT03555994|183358074|SUPERIORITY||Least Square Mean difference|-11.72||||0.03||90.0|-20.13|-3.3|||ANCOVA|||||-3.30|-20.13|0.030
91731800|NCT03379870|183358090|SUPERIORITY|Analyzed Consonant Nucleus Consonant (CNC) Word scores obtained 12-months post-activation to evaluate differences between groups. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).||||||0.768||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.768
91731801|NCT03379870|183358091|SUPERIORITY|Analyzed BKB-SIN scores obtained 12-months post-activation to evaluate differences between groups. Scores range from -6 to +21 and lower scores are better.||||||0.529||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.529
91731802|NCT03379870|183358092|SUPERIORITY|Analyzed SSQ scores obtained pre-operatively and at 12-months post-activation to evaluate benefit of cochlear implantation.||||||0.01||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.010
91731803|NCT03379870|183358093|SUPERIORITY|Analyzed receptive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.|||||>|0.069||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||>.069
91731804|NCT03379870|183358094|SUPERIORITY|Analyzed articulation scores pre-operative and 12-months post activation to test for change over time and differences between groups.||||||0.02||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post-activation)||||||.02
91731805|NCT03379870|183358095|SUPERIORITY|Analyzed expressive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.||||||0.007||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post activation)||||||.007
91731806|NCT01373281|183358100|SUPERIORITY_OR_OTHER_LEGACY||Vaccine efficacy|56.5|||||TWO_SIDED|95.0|43.8|66.4||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||66.4|43.8|
91493643|NCT00668707|182858601|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.1|2.7||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Functional Scale.||2.7|-4.1|0.69
91528699|NCT03169881|182933373|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.88|TWO_SIDED|95.0|-3.09|2.64||The mean difference in Bayley-III cognitive scores between treatment groups was adjusted for center, gestational age group, and familial clustering.|Mixed Models Analysis||Adjusted mean difference in cognitive score for the Darbepoetin minus Placebo treatment groups.|Null hypothesis: Weekly administration of Darbepoetin during the neonatal period will not impact neurocognitive outcomes at 22-26 months compared to Placebo in premature infants 23 to 28 weeks gestation.||2.64|-3.09|0.88
91528700|NCT02090634|182933410|SUPERIORITY|||||||0.95||||||Cliff's d = 0.01; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to ARV medications.||||0.95
91701179|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.594|||||||Paired t-test|||Statistical analysis at Week 36||||0.594
91701180|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.788|||||||Paired t-test|||Statistical analysis at Week 48||||0.788
91701181|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.329|||||||Paired t-test|||Statistical analysis at Week 56||||0.329
91701182|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.716|||||||Paired t-test|||Statistical analysis at Week 68||||0.716
91701183|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.119|||||||Paired t-test|||Statistical analysis at Week 80||||0.119
91701184|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.201|||||||Paired t-test|||Statistical analysis at Week 92||||0.201
91701185|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.087|||||||Paired t-test|||Statistical analysis at Week 104||||0.087
91701186|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.116
91701187|NCT01668966|183297164|SUPERIORITY_OR_OTHER|||||||0.07|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.070
91701188|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.3299|||||||Paired t-test|||Statistical analysis at Week 12||||0.3299
91701189|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.9247|||||||Paired t-test|||Statistical analysis at Week 24||||0.9247
91701190|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.9602|||||||Paired t-test|||Statistical analysis at Week 36||||0.9602
91701191|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.2773|||||||Paired t-test|||Statistical analysis at Week 48||||0.2773
91701192|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.5031|||||||Paired t-test|||Statistical analysis at Week 56||||0.5031
91701193|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.8109|||||||Paired t-test|||Statistical analysis at Week 68||||0.8109
91701194|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.254|||||||Paired t-test|||Statistical analysis at Week 80||||0.2540
91701195|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Paired t-test|||Statistical analysis at Week 92||||0.3794
91701196|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.8687|||||||Paired t-test|||Statistical analysis at Week 104||||0.8687
91701197|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.4685|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4685
91701198|NCT01668966|183297165|SUPERIORITY_OR_OTHER|||||||0.0511|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0511
91701199|NCT01573767|183297166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.227|TWO_SIDED|95.0|-2.7|11.4||Inference for VI 12.5 µg versus (vs) placebo was dependent upon statistical significance (SS) having first been achieved for VI 25 µg vs placebo; inference for VI 6.25 µg vs placebo was dependent on SS having been achieved for VI 12.5 µg vs placebo.|ANCOVA|||||11.4|-2.7|0.227
91701200|NCT01573767|183297166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.073|TWO_SIDED|95.0|-0.6|13.5|||ANCOVA|||||13.5|-0.6|0.073
91701201|NCT01573767|183297166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5||||0.127|TWO_SIDED|95.0|-1.6|12.5|||ANCOVA|||||12.5|-1.6|0.127
91701202|NCT01573767|183297167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057|||||TWO_SIDED|95.0|-0.138|0.024||||||||0.024|-0.138|
91701203|NCT01573767|183297167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.063|0.096||||||||0.096|-0.063|
91701204|NCT01573767|183297167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.051||||||||0.051|-0.110|
91701205|NCT01573767|183297168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-10.5|6.0||||||||6.0|-10.5|
91701206|NCT01573767|183297168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-6.9|9.6||||||||9.6|-6.9|
91701207|NCT01573767|183297168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|0.4|17.0||||||||17.0|0.4|
91701208|NCT01573767|183297169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-1.2|12.3||||||||12.3|-1.2|
91701209|NCT01573767|183297169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.7|14.2||||||||14.2|0.7|
91701210|NCT01573767|183297169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2||||||95.0|0.4|14.0||||||||14.0|0.4|
91701211|NCT01573767|183297170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-6.1|13.1||||||||13.1|-6.1|
91493644|NCT00668707|182858601|SUPERIORITY||Mean Difference (Net)|-3.8||||0.11|TWO_SIDED|95.0|-8.5|0.9||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Global Scale.||0.9|-8.5|0.11
91493645|NCT00668707|182858602|SUPERIORITY||Mean Difference (Net)|-3.1||||0.13|TWO_SIDED|95.0|-7.2|0.9|||Mixed Models Analysis|||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||0.9|-7.2|0.13
91493646|NCT00668707|182858603|SUPERIORITY||Mean Difference (Net)|-4.1||||0.18|TWO_SIDED|95.0|-10.0|1.9|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep Adequacy Analysis.||1.9|-10.0|0.18
91701212|NCT01573767|183297170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.8|17.4||||||||17.4|-1.8|
91701213|NCT01573767|183297170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|||||TWO_SIDED|95.0|-4.4|14.9||||||||14.9|-4.4|
91493647|NCT00668707|182858603|SUPERIORITY||Mean Difference (Net)|1.4||||0.41|TWO_SIDED|95.0|-2.0|4.8|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep problems index II analysis.||4.8|-2.0|0.41
91493648|NCT00668707|182858607|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
91493649|NCT00668707|182858608|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|95.0|0.85|1.07|||Log Rank|||DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.07|0.85|0.41
91493650|NCT00668707|182858608|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66|TWO_SIDED|95.0|0.85|1.11|||Log Rank|||This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.11|0.85|0.66
91493651|NCT00668707|182858608|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.92|||Log Rank|||This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||0.92|0.61|0.004
91528701|NCT02090634|182933410|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Cliff's d = -0.13; calculated to estimate the effect size for between-group comparisons with non-parametric data||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to PSY medications.||||0.43
91528702|NCT02090634|182933411|SUPERIORITY|||||||0.02||||||Cliff's d = 0.37; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for ARV medications.||||0.02
91528703|NCT02090634|182933411|SUPERIORITY|||||||0.42||||||Cliff's d = 0.14; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for PSY medications.||||0.42
91528704|NCT01861457|182933430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91528705|NCT01861457|182933431|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91493652|NCT00668707|182858609|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.95|TWO_SIDED|95.0|-3.21|4.56|||Wilcoxon (Mann-Whitney)|||Analysis of melatonin changes||4.56|-3.21|0.95
91528706|NCT01567865|182933437|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|1.84|||||TWO_SIDED|95.0|-5.97|9.66||||||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||9.66|-5.97|
91493653|NCT00668707|182858609|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.02|TWO_SIDED|95.0|-0.15|7.42|||Wilcoxon (Mann-Whitney)|||Analysis of placebo changes||7.42|-0.15|0.02
91493654|NCT00668707|182858610|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
91493655|NCT00668707|182858611|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||This analysis compares the mean ratios of 6 month cytotoxicity and baseline cytotoxicity between arms.||||0.34
91493656|NCT03846804|182858641|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91493657|NCT05438888|182858649|OTHER||Hazard Ratio (HR)|0.753|||<|0.001|TWO_SIDED|95.0|0.711|0.798|||Log Rank|||||0.798|0.711|<0.001
91493658|NCT05438888|182858650|OTHER||Hazard Ratio (HR)|0.687|||<|0.001|TWO_SIDED|95.0|0.622|0.76|||Log Rank|||||0.760|0.622|<0.001
91493659|NCT05438888|182858651|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.714|||Log Rank|||||0.714|0.570|<0.001
91535600|NCT00991276|182949769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.04|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|0.63|1.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.45|0.63|<0.0001
91701214|NCT01573767|183297171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-3.7|15.6||||||||15.6|-3.7|
91701215|NCT01573767|183297171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||||TWO_SIDED|95.0|0.0|19.3||||||||19.3|0.0|
91701216|NCT01573767|183297171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||||95.0|-2.7|16.7||||||||16.7|-2.7|
91701217|NCT01573767|183297172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.2|7.5||||||||7.5|-7.2|
91701218|NCT01573767|183297172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3|||||TWO_SIDED|95.0|1.0|15.7||||||||15.7|1.0|
91701219|NCT01573767|183297172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|2.3|17.2||||||||17.2|2.3|
91701220|NCT02961062|183297183|SUPERIORITY||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|0.0||0.005|TWO_SIDED|90.0|-17.54|-4.71|||Kenward-Roger method|||||-4.71|-17.54|0.005
91701221|NCT02961062|183297184|SUPERIORITY||Median Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.37||0.017|TWO_SIDED|90.0|-14.29|-2.83|||Kenward-Roger method|||||-2.83|-14.29|0.017
91701222|NCT01629823|183297196|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.51|TWO_SIDED|95.0|0.44|1.5||Comparison of 5cm group to control. No adjustment for multiple comparisons.|Regression, Linear|||Both the 5 and 10cm groups were compared to the control group, \<1cm H₂O||1.50|0.44|0.51
91701223|NCT01629823|183297196|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.57|TWO_SIDED|95.0|0.47|1.52|||Regression, Linear|||||1.52|0.47|0.57
91493660|NCT05438888|182858652|OTHER||Hazard Ratio (HR)|0.854|||<|0.001|TWO_SIDED|95.0|0.791|0.922|||Log Rank|||||0.922|0.791|<0.001
91493661|NCT05438888|182858653|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.715|||Log Rank|||||0.715|0.570|<0.001
91493662|NCT05438888|182858654|OTHER||Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.807|0.934|||Log Rank|||||0.934|0.807|<0.001
91493663|NCT05438888|182858655|OTHER||Hazard Ratio (HR)|0.646|||<|0.001|TWO_SIDED|95.0|0.503|0.83|||Log Rank|||||0.830|0.503|<0.001
91493664|NCT00844831|182858746|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
91493665|NCT00844831|182858748|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.9
91493666|NCT03156543|182858760|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Analysis was based on the participants who were positive for C. acnes.||||0.004
91493667|NCT00056316|182858778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
91493668|NCT00056316|182858779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.07||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
91493669|NCT01315678|182858788|SUPERIORITY||Cox Proportional Hazard|1.51||||0.0286|TWO_SIDED|95.0|1.07|2.13|||Regression, Cox|||Stratified Cox proportional hazards model||2.13|1.07|0.0286
91493670|NCT01315678|182858789|SUPERIORITY||Cox Proportional Hazard|1.12||||0.6031|TWO_SIDED|95.0|0.76|1.66|||Regression, Cox|||||1.66|0.76|0.6031
91493671|NCT01315678|182858790|SUPERIORITY||Cox Proportional Hazard|0.84||||0.4861|TWO_SIDED|95.0|0.49|1.44|||Regression, Cox|||||1.44|0.49|0.4861
91493672|NCT00790023|182858798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.0001|TWO_SIDED|95.0|0.57|1.32||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.32|0.57|<0.0001
91493673|NCT00790023|182858798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.0001|TWO_SIDED|95.0|0.7|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.70|<0.0001
91493674|NCT00790023|182858799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.5|1.25|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.25|0.50|<0.0001
91493675|NCT00790023|182858799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.63|1.37|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.37|0.63|<0.0001
91493676|NCT00790023|182858800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.0004|TWO_SIDED|95.0|0.28|0.95|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.95|0.28|0.0004
91493677|NCT00790023|182858800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0005|TWO_SIDED|95.0|0.27|0.94|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.94|0.27|0.0005
91493678|NCT00004978|182858835|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.55|TWO_SIDED|95.0|0.75|1.16||P-value is 2-sided using an alpha of .05.|Regression, Cox|Hazard ratio is from unadjusted proportional hazards regression model.|HR is for rIL-2 vs control.|||1.16|0.75|.55
91493679|NCT00004978|182858836|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.62|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||||1.20|0.74|.62
91493680|NCT00004978|182858837|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.42|TWO_SIDED|95.0|0.69|1.17|||Regression, Cox|||||1.17|0.69|.42
91493681|NCT00004978|182858838|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|||||1.14|0.73|.41
91493682|NCT00004978|182858839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|159.0|||||TWO_SIDED|95.0|145.0|174.0|||||treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits|||174|145|
91493683|NCT00004978|182858841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.07|TWO_SIDED|95.0|0.88|1.0|||Regression, Cox|Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.||||1.00|0.88|.07
91493684|NCT00004978|182858842|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.003|TWO_SIDED|95.0|1.07|1.41|||Regression, Cox||HR (IL-2 vs control) for first grade 4 event, ITT analysis.|||1.41|1.07|.003
91493685|NCT00004978|182858843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||Chi-squared|||||||.97
91493686|NCT00004978|182858844|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.76|1.22|||Regression, Cox|||||1.22|0.76|.74
91513276|NCT01038921|182898023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.013|||||||Mixed Models Analysis|||Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.||||0.013
91701224|NCT00455520|183297202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.7|-0.92|||ANCOVA|||Analysis of Covariance Model with factors of treatment, country, prior opioid use, and baseline dose level and start of DB pain score as factors.||-0.92|-1.7|<0.001
91493687|NCT02155608|182858856|SUPERIORITY|||||||0.54||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .38, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.54
91513277|NCT02480621|182898096|SUPERIORITY||Mean Difference (Net)|1.74|||<|0.1|TWO_SIDED||||||t-test, 2 sided|||||||<0.10
91513278|NCT01975389|182898126|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.021469|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.65|0.021469
91701225|NCT04601103|183297216|OTHER|Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing||||||0.916|||||||Fisher Exact|||||||.916
91701226|NCT02719938|183297229|SUPERIORITY|||||||0.415|||||||t-test, 2 sided|||||||0.415
91513279|NCT01975389|182898127|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.007597|TWO_SIDED|95.0|0.6|0.93|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.93|0.60|0.007597
91701227|NCT02719938|183297230|SUPERIORITY|||||||0.521|||||||t-test, 2 sided|||||||0.521
91701228|NCT02719938|183297231|SUPERIORITY|||||||0.409|||||||t-test, 2 sided|||||||0.409
91701229|NCT02719938|183297232|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
91701230|NCT02719938|183297233|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91701231|NCT02719938|183297234|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91701232|NCT02719938|183297235|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
91701233|NCT01032239|183297299|SUPERIORITY||Hodges-Lehmann|-0.667||||0.014|TWO_SIDED|95.1|-1.0|-0.1667|||Wilcoxon (Mann-Whitney)|||To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.||-0.1667|-1.000|0.0140
91513280|NCT01975389|182898128|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.035958|TWO_SIDED|95.0|0.68|0.99|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.99|0.68|0.035958
91513281|NCT01975389|182898129|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.015694|TWO_SIDED|95.0|0.64|0.95|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.95|0.64|0.015694
91701234|NCT01032239|183297300|SUPERIORITY||Hodges-Lehmann|-0.6||||0.0042|TWO_SIDED|95.0|-1.0|-0.2|||Wilcoxon (Mann-Whitney)|||||-0.2000|-1.0000|0.0042
91701235|NCT01032239|183297301|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.0540
91701236|NCT01032239|183297302|SUPERIORITY|||||||0.6256|||||||Wilcoxon (Mann-Whitney)|||||||0.6256
91701237|NCT01032239|183297303|SUPERIORITY|||||||0.3676|||||||Cochran-Mantel-Haenszel|||||||0.3676
91701238|NCT01032239|183297304|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Actual Pain||||0.0380
91701239|NCT01032239|183297304|SUPERIORITY|||||||0.0136|||||||Wilcoxon (Mann-Whitney)|||Least Pain||||0.0136
91701240|NCT01032239|183297304|SUPERIORITY|||||||0.2427|||||||Wilcoxon (Mann-Whitney)|||Worst Pain||||0.2427
91701241|NCT01032239|183297305|SUPERIORITY|||||||0.7661|||||||Fisher Exact|||||||0.7661
91701242|NCT01032239|183297306|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||Utility Score||||0.0197
91701243|NCT01032239|183297306|SUPERIORITY|||||||0.3807|||||||t-test, 2 sided|||VAS||||0.3807
91701244|NCT01032239|183297307|SUPERIORITY|||||||0.1068|||||||t-test, 2 sided|||PCS||||0.1068
91701245|NCT01032239|183297307|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||MCS||||0.6824
91701246|NCT01032239|183297308|SUPERIORITY|||||||0.2105|||||||t-test, 2 sided|||||||0.2105
91701247|NCT04713592|183297328|SUPERIORITY||Rate Difference|17.2|||=|0.006|TWO_SIDED|95.0|5.0|29.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||29.3|5.0|=0.006
91513282|NCT01975389|182898130|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.814224|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.46|0.62|0.814224
91513283|NCT01975389|182898131|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018053|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.96|0.65|0.018053
91513284|NCT01975389|182898132|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.446033|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.36|0.50|0.446033
91493688|NCT02155608|182858856|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance|Mixed Models Analysis|Time: F=39.97, df = 1/228||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
91493689|NCT02155608|182858856|SUPERIORITY|||||||0.005||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 8.12, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.005
91701248|NCT04713592|183297330|SUPERIORITY||Rate Difference|27.6|||<|0.001|TWO_SIDED|95.0|15.4|39.7||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||39.7|15.4|<0.001
91701249|NCT04713592|183297331|SUPERIORITY||Rate Difference|21.8|||<|0.001|TWO_SIDED|95.0|11.5|32.1||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.1|11.5|<0.001
91701250|NCT04713592|183297332|SUPERIORITY||Rate Difference|20.7|||<|0.001|TWO_SIDED|95.0|9.1|32.2||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.2|9.1|<0.001
91701251|NCT04713592|183297333|SUPERIORITY||Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|8.2|24.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||24.3|8.2|<0.001
91701252|NCT01056198|183297343|SUPERIORITY_OR_OTHER||||||=|0.208||95.0|||||ANCOVA|||The BWAT-m scores were compared at each of the 4 treatment weeks and at the end of the follow-up using a mixed-effects ANCOVA for the intent-to-treat population. Treatment and treatment week, as well as their interaction, were defined as fixed effects with subject as a random effect. The BWAT-m score at baseline was used as a covariate.||||=0.208
91701253|NCT01056198|183297344|SUPERIORITY_OR_OTHER||||||=|0.2737||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2737
91701254|NCT01056198|183297345|SUPERIORITY_OR_OTHER||||||=|0.2741||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2741
91701255|NCT01056198|183297346|SUPERIORITY_OR_OTHER||||||=|0.0164||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.0164
91701256|NCT01056198|183297347|SUPERIORITY_OR_OTHER||||||=|0.9392||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.9392
91701257|NCT02431806|183297352|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.8035|TWO_SIDED|95.0|-3.41|2.64|||Mixed Model Repeated Measures (MMRM)||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||2.64|-3.41|0.8035
91701258|NCT02431806|183297352|SUPERIORITY||LS Mean Difference|0.26||||0.8681|TWO_SIDED|95.0|-2.8|3.31|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||3.31|-2.80|0.8681
91701259|NCT02431806|183297352|SUPERIORITY||LS Mean|-1.47||||0.3439|TWO_SIDED|95.0|-4.52|1.58|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||1.58|-4.52|0.3439
91701260|NCT02431806|183297353|SUPERIORITY||LS Mean Difference|0.02||||0.8788|TWO_SIDED|95.0|-0.25|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.25|0.8788
91701261|NCT02431806|183297353|SUPERIORITY||LS Mean Difference|0.01||||0.923|TWO_SIDED|95.0|-0.26|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.26|0.9230
91701262|NCT02431806|183297353|SUPERIORITY||LS Mean Difference|-0.15||||0.2895|TWO_SIDED|95.0|-0.42|0.13|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.13|-0.42|0.2895
91701263|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.38|STANDARD_ERROR_OF_MEAN|5.449|||TWO_SIDED|95.0|-5.75|24.51|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||24.51|-5.75|
91701264|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.55|STANDARD_ERROR_OF_MEAN|5.849|||TWO_SIDED|95.0|-8.68|23.79|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||23.79|-8.68|
91701265|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92|STANDARD_ERROR_OF_MEAN|3.645|||TWO_SIDED|95.0|-12.04|8.2|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||8.20|-12.04|
91493690|NCT02155608|182858856|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time2: F = 28.96, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
91493691|NCT02155608|182858856|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 6.23, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.02
91493692|NCT02155608|182858856|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 4.18, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
91493693|NCT02155608|182858856|SUPERIORITY|||||||0.73||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .12, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
91493694|NCT02155608|182858857|SUPERIORITY|||||||0.003||||||p \< .05 for statistical significance|Chi-squared|Group: F = 8.75, df = 1/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.003
91701266|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.21|STANDARD_ERROR_OF_MEAN|6.361|||TWO_SIDED|95.0|-3.45|31.87|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||31.87|-3.45|
91493695|NCT02155608|182858857|SUPERIORITY|||||||0.17||||||p \< .05 for statistical significance.|Chi-squared|Time: F = 1.69, df = 3/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.17
91701267|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-10.12|10.92|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||10.92|-10.12|
91493696|NCT02155608|182858857|SUPERIORITY|||||||0.46|||||||Chi-squared|Group: Chi-square = .53, df = 1.||Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline.||||.46
91493697|NCT02155608|182858858|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|Group: F=.01; df =1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.91
91493698|NCT02155608|182858858|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F=13.03; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.0004
91493699|NCT02155608|182858858|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|Group \* time: F = .83; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.37
91493700|NCT02155608|182858858|SUPERIORITY|||||||0.007||||||Time2: F = 7.45, df = 1/209.|Mixed Models Analysis|||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.007
91701268|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.04|STANDARD_ERROR_OF_MEAN|4.281|||TWO_SIDED|95.0|13.16|36.93|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||36.93|13.16|
91701269|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|10.62||||95.0|-29.94|29.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||29.03|-29.94|
91493701|NCT02155608|182858858|SUPERIORITY|||||||0.67||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .19, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.67
91493702|NCT02155608|182858858|SUPERIORITY|||||||0.68||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .17, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.68
91493703|NCT02155608|182858858|SUPERIORITY|||||||0.16||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.05, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.16
91493704|NCT02155608|182858859|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
91701270|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31|STANDARD_ERROR_OF_MEAN|7.194|||TWO_SIDED|95.0|-11.67|28.28|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||28.28|-11.67|
91493705|NCT02155608|182858859|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.12, df = .15||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.15
91493706|NCT02155608|182858859|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .21, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
91493707|NCT02155608|182858859|SUPERIORITY|||||||0.66||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .20, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.66
91493708|NCT02155608|182858859|SUPERIORITY|||||||0.48||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .50, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.48
91493709|NCT02155608|182858859|SUPERIORITY|||||||0.81||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.81
91493710|NCT02155608|182858860|SUPERIORITY|||||||0.89||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .02, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.89
91528707|NCT01567865|182933437|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-2.48|||<|0.05|TWO_SIDED|95.0|-9.92|4.98|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||4.98|-9.92|<0.05
91528708|NCT01567865|182933437|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-4.33|||<|0.05|TWO_SIDED|95.0|-11.94|3.31|||t-test, 2 sided|||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||3.31|-11.94|<0.05
91701271|NCT00742508|183297358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.63|0.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.15|-0.63|
91493711|NCT02155608|182858860|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.28, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.14
91493712|NCT02155608|182858860|SUPERIORITY|||||||0.8||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = .81.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.80
91701272|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|4.833|||TWO_SIDED|95.0|-11.2|15.63|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||15.63|-11.20|
91493713|NCT02155608|182858860|SUPERIORITY|||||||0.93||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.93
91493714|NCT02155608|182858860|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.22, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
91493715|NCT02155608|182858860|SUPERIORITY|||||||0.28||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.23, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.28
91493716|NCT02155608|182858861|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01; df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
91493717|NCT02155608|182858861|SUPERIORITY|||||||0.11||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.62, df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.11
91493718|NCT02155608|182858861|SUPERIORITY|||||||0.4||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .71; df = .40.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.40
91701273|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|6.265|||TWO_SIDED|95.0|-17.95|16.84|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||16.84|-17.95|
91701274|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.93|STANDARD_ERROR_OF_MEAN|3.885|||TWO_SIDED|95.0|-15.71|5.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||5.86|-15.71|
91493719|NCT02155608|182858861|SUPERIORITY|||||||0.49||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .48. df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.49
91493720|NCT02155608|182858861|SUPERIORITY|||||||0.18||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.87, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.18
91493721|NCT02155608|182858861|SUPERIORITY|||||||0.72||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .13, df = 1/38.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.72
91493722|NCT02155608|182858862|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|Group: F =.25, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.62
91493723|NCT02155608|182858862|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Time: F = 3.58, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.06
91731807|NCT01373281|183358103|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|55.4|||||TWO_SIDED|95.0|47.3|62.3||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||62.3|47.3|
91731808|NCT01373281|183358104|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|57.9|||||TWO_SIDED|95.0|49.0|65.2||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||65.2|49.0|
91731809|NCT01373281|183358105|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|54.8|||||TWO_SIDED|95.0|46.8|61.7||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||61.7|46.8|
91731810|NCT05796245|183358125|OTHER|Estimation|Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.39|5.2|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.20|0.39|
91493724|NCT02155608|182858862|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.90, df 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.09
91731811|NCT05796245|183358125|OTHER|Estimation|Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.38|5.34|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.34|0.38|
91493725|NCT02155608|182858862|SUPERIORITY|||||||0.06||||||p \< .05 for statistical significance|Mixed Models Analysis|Group: F = 3.36, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.06
91493726|NCT02155608|182858862|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.20, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
91493727|NCT02155608|182858862|SUPERIORITY|||||||0.42||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .66, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.42
91493728|NCT02155608|182858863|SUPERIORITY|||||||0.29||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 0.29, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.29
91493729|NCT02155608|182858863|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.83, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
91493730|NCT02155608|182858863|SUPERIORITY|||||||0.31||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.03, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.31
91731812|NCT05796245|183358125|OTHER|Estimation|Risk Difference (RD)|0.04|||||TWO_SIDED|95.0|-0.2|0.11|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.11|-0.20|
91731813|NCT05796245|183358125|OTHER|Estimation|Cox Proportional Hazard|1.63|||||TWO_SIDED|95.0|0.54|4.9|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||4.90|0.54|
91731814|NCT05796245|183358125|OTHER|Estimation|Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|0.55|5.26|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||5.26|0.55|
91731815|NCT05796245|183358125|OTHER|Estimation|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.39|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.39|-0.10|
91731816|NCT05796245|183358125|OTHER|Estimation|Cox Proportional Hazard|2.44|||||TWO_SIDED|95.0|1.05|5.67|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.67|1.05|
91731817|NCT05796245|183358125|OTHER|Estimation|Risk Ratio (RR)|2.47|||||TWO_SIDED|95.0|1.02|5.99|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.99|1.02|
91731818|NCT05796245|183358125|OTHER|Estimation|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.06|0.32|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.32|-0.06|
91493731|NCT02155608|182858863|SUPERIORITY|||||||0.69||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.69
91493732|NCT02155608|182858863|SUPERIORITY|||||||0.33||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .98, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.33
91493733|NCT02155608|182858863|SUPERIORITY|||||||0.35||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .88, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.35
91731819|NCT05796245|183358126|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.01|0.0|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the Comparative analysis set (IPTW weighted) and for the Comparative matched analysis set could not be calculated. Also, crude hazard ratio and crude risk ratio could not be calculated.||0.00|-0.01|
91493734|NCT02155608|182858864|SUPERIORITY|||||||0.21||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 1.62, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.21
91493735|NCT02155608|182858864|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.18, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
91493736|NCT02155608|182858864|SUPERIORITY|||||||0.01||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 6.89, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.01
91493737|NCT02155608|182858864|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F= 2.16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
91493738|NCT02155608|182858864|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.15, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
91493739|NCT02155608|182858864|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
91493740|NCT02155608|182858865|SUPERIORITY|||||||0.94||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.94
91493741|NCT02155608|182858865|SUPERIORITY|||||||0.76||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .09, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.76
91493742|NCT02155608|182858865|SUPERIORITY|||||||0.39||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .75, df =1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.39
91493743|NCT02155608|182858865|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.06, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.09
91493744|NCT02155608|182858865|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
91493745|NCT02155608|182858865|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.55, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.22
91493746|NCT02155608|182858866|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .22, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
91493747|NCT02155608|182858866|SUPERIORITY|||||||0.19||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.19
91493748|NCT02155608|182858866|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.22
91493749|NCT02155608|182858866|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.95, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
91731820|NCT05796245|183358127|OTHER|Estimation|Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.12|12.49|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||12.49|0.12|
91731821|NCT05796245|183358127|OTHER|Estimation|Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.12|17.14|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.14|0.12|
91731822|NCT05796245|183358127|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.05|0.01|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.01|-0.05|
91493750|NCT02155608|182858866|SUPERIORITY|||||||0.96||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 0.00, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.96
91493751|NCT02155608|182858866|SUPERIORITY|||||||0.92||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .01, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.92
91493752|NCT02155608|182858867|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .07, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.79
91493753|NCT02155608|182858867|SUPERIORITY|||||||0.3||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.10, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.30
91493754|NCT02155608|182858867|SUPERIORITY|||||||0.03||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 4.61, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.03
91701275|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-7.11|26.59|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||26.59|-7.11|
91701276|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|4.08|||TWO_SIDED|95.0|-14.78|7.88|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||7.88|-14.78|
91701277|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.06|STANDARD_ERROR_OF_MEAN|1.694|||TWO_SIDED|95.0|13.36|22.76|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||22.76|13.36|
91701278|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.46|STANDARD_ERROR_OF_MEAN|8.902|||TWO_SIDED|95.0|-32.17|17.26|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||17.26|-32.17|
91701279|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|5.297|||TWO_SIDED|95.0|-13.61|15.8|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||15.80|-13.61|
91701280|NCT00742508|183297378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.54|0.3|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.30|-0.54|
91701281|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.99|STANDARD_ERROR_OF_MEAN|3.187|||TWO_SIDED|95.0|-12.84|4.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||4.86|-12.84|
91701282|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.27|STANDARD_ERROR_OF_MEAN|2.962|||TWO_SIDED|95.0|-13.5|2.95|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||2.95|-13.50|
91493755|NCT02155608|182858867|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 2.24, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.14
91701283|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98|STANDARD_ERROR_OF_MEAN|3.209|||TWO_SIDED|95.0|-10.89|6.94|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||6.94|-10.89|
91701284|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.14|STANDARD_ERROR_OF_MEAN|3.665|||TWO_SIDED|95.0|-14.32|6.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||6.03|-14.32|
91701285|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.99|STANDARD_ERROR_OF_MEAN|3.047|||TWO_SIDED|95.0|-11.45|5.47|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||5.47|-11.45|
91701286|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|4.686|||TWO_SIDED|95.0|-16.12|9.89|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||9.89|-16.12|
91701287|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|STANDARD_ERROR_OF_MEAN|3.749|||TWO_SIDED|95.0|-20.41|0.41|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||0.41|-20.41|
91701288|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|5.249|||TWO_SIDED|95.0|-16.0|13.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||13.15|-16.00|
91701289|NCT00742508|183297379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.71|0.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.03|-0.71|
91493756|NCT02155608|182858867|SUPERIORITY|||||||0.82||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .05, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.82
91493757|NCT02155608|182858867|SUPERIORITY|||||||0.07||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 3.35, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.07
91493758|NCT02155608|182858868|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|Group: F = .36, df = 1/52||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.55
91701290|NCT02426749|183297399|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91701291|NCT02484651|183297423|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Sample size calculation was performed with a power of 0.80 and an α of 0.05, considering the primary hypothesis of a reduction in the BIS variability (measured as the standard deviation). A 25% reduction on the BIS variability (standard deviation) was considered clinically relevant, and gave a minimum sample size of 26 per group.||||0.651
91493759|NCT02155608|182858868|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Time: F = .09, df = 1/52||Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.||||.34
91493760|NCT02155608|182858868|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|Group \* time: F = .06, df = 1/52||Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects.||||.81
91493761|NCT02155608|182858868|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Group: F = .05, df = 1/59||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.83
91493762|NCT02155608|182858868|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|Time: F = 4.52, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.04
91493763|NCT02155608|182858868|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|Group \* time: F = .12, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
91493764|NCT02155608|182858869|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.62, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.21
91493765|NCT02155608|182858869|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Time: F = .74, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.39
91493766|NCT02155608|182858869|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|Time2: F = 1.88, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.18
91528709|NCT01567865|182933437|NON_INFERIORITY|The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.|Mean Difference (Net)|-4.03|||<|0.05|TWO_SIDED|95.0|-9.74|3.1|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%."||3.1|-9.74|<0.05
91528710|NCT05569954|182933489|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-1.6|||||TWO_SIDED|95.0|-4.0|0.7|||||V116 minus PPSV23|Injection site erythema: estimated difference in percent||0.7|-4.0|
91493767|NCT02155608|182858869|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|Group \* time: F = 1.56; df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.22
91731823|NCT05796245|183358127|OTHER|Estimation|Cox Proportional Hazard|6.12|||||TWO_SIDED|95.0|0.81|45.94|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the comparative matched analysis set could not be calculated.||45.94|0.81|
91493768|NCT02155608|182858869|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.72, df = 1/12.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.21
91493769|NCT02155608|182858869|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Time: F = 0.00, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
91493770|NCT02155608|182858869|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Group \* time: F = .87, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
91731824|NCT05796245|183358127|OTHER|Estimation|Risk Ratio (RR)|7.07|||||TWO_SIDED|95.0|0.93|53.51|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||53.51|0.93|
91493771|NCT00869349|182858878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||0.0|-1.1|0.04
91493772|NCT00869349|182858879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.01|TWO_SIDED|95.0|-5.6|-0.8||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||-0.8|-5.6|0.01
91493773|NCT00869349|182858880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.01|TWO_SIDED|95.0|0.5|3.1||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||3.1|0.5|0.01
91701292|NCT02484651|183297424|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This statistical analysis applies to the propofol effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the propofol drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on propofol mean effect-site concentration of 20% was considered clinically relevant, giving a minimum of 34 patients per group||||<0.001
91493774|NCT03984994|182858965|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.27|TWO_SIDED||||||t-test, 2 sided|||"Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group."||||0.27
91493775|NCT03984994|182858966|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.22|TWO_SIDED||||||t-test, 2 sided|||"Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group."||||0.22
91528711|NCT05569954|182933489|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|3.7|||||TWO_SIDED|95.0|-1.2|8.7|||||V116 minus PPSV23|Injection site pain: estimated difference in percent||8.7|-1.2|
91528712|NCT05569954|182933489|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.6|||||TWO_SIDED|95.0|-1.6|2.7|||||V116 minus PPSV23|Injection site swelling: estimated difference in percent||2.7|-1.6|
91701293|NCT02484651|183297424|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||"This statistical analysis applies to the remifentanil effect-site concentration.~Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group"||||0.245
91701294|NCT02484651|183297425|SUPERIORITY|||||||0.419|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 15 minutes was independent from the study group.||||0.419
91701295|NCT02484651|183297425|SUPERIORITY|||||||0.107|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 40 minutes was independent from the study group.||||0.107
91701296|NCT02484651|183297426|SUPERIORITY|||||||0.669|||||||Chi-squared|||The null hypothesis was that PQRS satisfaction with anesthetic care was independent of the study group.||||0.669
91701297|NCT04972968|183297433|SUPERIORITY||Cox Proportional Hazard|0.49||||0.012|TWO_SIDED|95.0|0.273|0.878||P-value \<= 0.05|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\].||||0.878|0.273|0.012
91701298|NCT04972968|183297433|SUPERIORITY||Cox Proportional Hazard|0.443||||0.004|TWO_SIDED|95.0|0.248|0.794||P-value \<= 0.01|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.794|0.248|0.004
91701299|NCT04972968|183297433|SUPERIORITY||Cox Proportional Hazard|0.198|||<|0.001|TWO_SIDED|95.0|0.094|0.419||P-value \<= 0.001|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.419|0.094|<0.001
91493776|NCT03984994|182858967|SUPERIORITY||Mean Difference (Final Values)|251.0||||0.21|TWO_SIDED||||||t-test, 2 sided|||"Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group."||||0.21
91528713|NCT05569954|182933490|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.9|||||TWO_SIDED|95.0|-2.9|4.6|||||V116 minus PPSV23|Fatigue: estimated difference in percent||4.6|-2.9|
91701300|NCT04972968|183297434|SUPERIORITY||Mean Difference (Net)|18.7||||0.107|TWO_SIDED|95.0|-4.0|41.4|||Cochran-Mantel-Haenszel||From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid (GC) use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.4|-4.0|0.107
91701301|NCT04972968|183297434|SUPERIORITY||Mean Difference (Net)|18.9||||0.092|TWO_SIDED|95.0|-3.1|41.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.0|-3.1|0.092
91701302|NCT04972968|183297434|SUPERIORITY||Mean Difference (Net)|41.9|||<|0.001|TWO_SIDED|95.0|21.4|62.3||P-value ≤ 0.001|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||62.3|21.4|< 0.001
91701303|NCT04972968|183297435|SUPERIORITY||Mean Difference (Net)|-88.67||||0.144|TWO_SIDED|95.0|-208.04|30.71|||ANCOVA|P-value based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors.|95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[GC use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent);|||30.71|-208.04|0.144
91701304|NCT04972968|183297435|SUPERIORITY||Mean Difference (Net)|-164.76||||0.007|TWO_SIDED|95.0|-283.62|-45.89||P-value ≤ 0.01|ANCOVA||P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone\] equivalent);|||-45.89|-283.62|0.007
91731825|NCT05796245|183358127|OTHER|Estimation|Risk Difference (RD)|0.03|||||TWO_SIDED|95.0|-0.04|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.04|
91493777|NCT03984994|182858968|SUPERIORITY||Mean Difference (Final Values)|10.7||||0.28|TWO_SIDED||||||t-test, 2 sided|||"Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.~The hypothesis was that the Aerobic exercise training followed by resistance training arm would have greater changes/improvements in study outcomes than the Resistance training followed by aerobic training group."||||0.28
91493778|NCT00709761|182858997|SUPERIORITY_OR_OTHER||percentage of participants|53.0||||||95.0|40.7|66.0|||||The estimation parameter represents the percentage of participants experiencing either a CR or a PR.|||66.0|40.7|
91493779|NCT04950998|182859020|SUPERIORITY||Mean Difference (Final Values)|604.07|STANDARD_DEVIATION|2560.36||0.376|TWO_SIDED|95.0|-813.815|2021.95|||t-test, 2 sided|||||2021.95|-813.815|0.376
91493780|NCT04950998|182859021|SUPERIORITY||Mean Difference (Final Values)|-35.019|STANDARD_DEVIATION|172.168||0.444|TWO_SIDED|95.0|-130.36|60.324|||t-test, 2 sided|||||60.324|-130.36|.444
91493781|NCT00555971|182859029|EQUIVALENCE|This was a statistical analysis to address the null hypothesis that there was no difference between treatment and placebo groups.||||||0.036|||||||Fisher Exact|||||||0.036
91493782|NCT02557555|182859109|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Researched options for labor pain|Test of equal proportion (50/50)|||||||<0.0001
91493783|NCT02557555|182859109|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Pamphlet better explained options for pain|Test of equal proportion (50/50)|||||||<0.0001
91528714|NCT05569954|182933490|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|1.7||||||95.0|-1.8|5.1|||||V116 minus PPSV23|Headache: estimated difference in percent||5.1|-1.8|
91528715|NCT05569954|182933490|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.7||||||95.0|-3.1|1.7|||||V116 minus PPSV23|Myalgia: estimated difference in percent||1.7|-3.1|
91528716|NCT05569954|182933490|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.3||||||95.0|-1.5|0.9|||||V116 minus PPSV23|Pyrexia: estimated difference in percent||0.9|-1.5|
91701305|NCT04972968|183297435|SUPERIORITY||Mean Difference (Final Values)|-182.55||||0.003|TWO_SIDED|95.0|-300.52|-64.58||P-value ≤ 0.01|ANCOVA||P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent)|||-64.58|-300.52|0.003
91701306|NCT04972968|183297436|SUPERIORITY||Mean Difference (Net)|-1.58||||0.039|TWO_SIDED|95.0|-3.08|-0.08||P-value \<= 0.05|ANCOVA|P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)||||-0.08|-3.08|0.039
91701307|NCT04972968|183297436|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.001|TWO_SIDED|95.0|-4.15|-1.16||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.16|-4.15|<0.001
91701308|NCT04972968|183297436|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.49|-1.52||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.52|-4.49|<0.001
91701309|NCT03649178|183297443|OTHER|||||||0.55|||||||Mixed Models Analysis|||||||0.55
91701310|NCT03649178|183297444|OTHER|||||||0.76|||||||Mixed Models Analysis|||||||0.76
91701311|NCT03649178|183297445|OTHER|||||||0.02|||||||Mixed Models Analysis|||||||0.02
91701312|NCT04120584|183297446|SUPERIORITY||Mean Difference (Final Values)|9.62|||<|0.001|TWO_SIDED|5.0|||||ANOVA|||||||<0.001
91701313|NCT04120584|183297447|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||ANOVA|||||||<0.001
91701314|NCT03660475|183297459|SUPERIORITY|||||||0.967|||||||t-test, 2 sided|||||||0.967
91701315|NCT03660475|183297460|SUPERIORITY|||||||0.836|||||||t-test, 2 sided|||||||0.836
91701316|NCT03660475|183297461|SUPERIORITY|||||||0.166|||||||t-test, 2 sided|||||||0.166
91701317|NCT03660475|183297462|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||0.638
91701318|NCT03660475|183297463|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
91701319|NCT03660475|183297464|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
91701320|NCT03660475|183297465|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
91701321|NCT03660475|183297467|SUPERIORITY|||||||0.903|||||||t-test, 2 sided|||||||0.903
91701322|NCT03660475|183297468|SUPERIORITY|||||||0.898|||||||t-test, 2 sided|||||||0.898
91701323|NCT03660475|183297469|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
91701324|NCT03660475|183297470|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
91701325|NCT00794040|183297489|SUPERIORITY||Odds Ratio (OR)|11.7||||0.006|TWO_SIDED|95.0|2.0|68.16||priori threshold p\<0.05|Multilevel growth curve model|||||68.16|2.00|0.006
91701326|NCT00794040|183297490|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.085|TWO_SIDED|95.0|-1.32|0.09||priori threshold \<0.05|Multilevel growth curve model|||||0.09|-1.32|0.085
91701327|NCT00794040|183297491|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.124|TWO_SIDED|95.0|-1.3|10.74||priori threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||10.74|-1.30|0.124
91701328|NCT00794040|183297492|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.993|TWO_SIDED|95.0|-4.76|4.8||priori threshold p\<0.05|Multilevel growth curve model|||||4.80|-4.76|0.993
91493784|NCT02557555|182859109|OTHER||||||<|0.0001||||||Pamphlet should be given before onset labor pain|Test of equal proportion (50/50)|||||||<0.0001
91493785|NCT02557555|182859109|OTHER||||||<|0.0001||||||Pamphlet information helped to reduce anxiety|Test of equal proportion (50/50)|||||||<0.0001
91528717|NCT05569954|182933491|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.0||||||95.0|-0.5|0.5|||||V116 minus PPSV23|Vaccine-Related Serious Adverse Events||0.5|-0.5|
91731826|NCT05796245|183358128|OTHER|Estimation|Cox Proportional Hazard|1.7|||||TWO_SIDED|95.0|0.16|17.61|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.61|0.16|
91731827|NCT05796245|183358128|OTHER|Estimation|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.17|19.79|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||19.79|0.17|
91701329|NCT00794040|183297493|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.598|TWO_SIDED|95.0|-4.23|2.19||priori threshold p\<0.05|Multilevel growth curve model|||||2.19|-4.23|0.598
91731828|NCT05796245|183358128|OTHER|Estimation|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-0.12|0.03|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.03|-0.12|
91731829|NCT05796245|183358128|OTHER|Estimation|Cox Proportional Hazard|2.61|||||TWO_SIDED|95.0|0.15|45.68|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||45.68|0.15|
91731830|NCT05796245|183358128|OTHER|Estimation|Risk Ratio (RR)|2.01|||||TWO_SIDED|95.0|0.12|34.94|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||34.94|0.12|
91731831|NCT05796245|183358128|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.1|0.26|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.26|-0.10|
91731832|NCT05796245|183358128|OTHER|Estimation|Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|0.37|19.93|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.93|0.37|
91731833|NCT05796245|183358128|OTHER|Estimation|Risk Ratio (RR)|2.66|||||TWO_SIDED|95.0|0.37|19.31|||||Crude Risk Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.31|0.37|
91731834|NCT05796245|183358128|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.05|
91731835|NCT05796245|183358129|OTHER|Estimation|Cox Proportional Hazard|0.18|||||TWO_SIDED|95.0|0.02|1.85|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.85|0.02|
91493786|NCT02557555|182859109|OTHER|||||||0.0002||||||Information corrected any misconception|Test of equal proportion (50/50)|||||||0.0002
91493787|NCT02557555|182859109|OTHER||||||<|0.0001||||||Written information should always be available|Test of equal proportion (50/50)|||||||<0.0001
91493788|NCT04967443|182859113|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.1|||||TWO_SIDED|90.0|96.14|108.43|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.43|96.14|
91528718|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.23||1-sided|cLDA model||V116/PPSV23|Serotype 3: V116/PPSV23 GMT Ratio||1.23|0.96|<0.001
91701330|NCT04687072|183297494|SUPERIORITY||Difference in percentage|-3.5||||0.5081|TWO_SIDED|95.0|-14.7|7.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% confidence interval (CI) (Klingenberg approach) were presented.|||7.0|-14.7|0.5081
91701331|NCT04687072|183297495|SUPERIORITY||Location shift|0.0||||0.4925|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.4925
91701332|NCT04687072|183297496|SUPERIORITY||Difference in percentage|-0.5||||0.9314|TWO_SIDED|95.0|-11.7|10.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% CI (Klingenberg approach) were presented.|||10.0|-11.7|0.9314
91701333|NCT04687072|183297497|SUPERIORITY||Difference in percentage|-1.7||||0.7379|TWO_SIDED|95.0|-12.4|8.2||The Cochran-Mantel-Haenszel test p-value was used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentage and 95% CI (Klingenberg approach) are presented.|||8.2|-12.4|0.7379
91701334|NCT04687072|183297498|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-9.3|16.8|||||||The 95% Agresti-Min CIs are presented.|16.8|-9.3|
91701335|NCT04687072|183297499|SUPERIORITY||Location shift|0.0||||0.726|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.7260
91731836|NCT05796245|183358129|OTHER|Estimation|Risk Ratio (RR)|0.19|||||TWO_SIDED|95.0|0.02|1.99|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.99|0.02|
91731837|NCT05796245|183358129|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.17|0.0|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.00|-0.17|
91731838|NCT05796245|183358129|OTHER|Estimation|Cox Proportional Hazard|0.63|||||TWO_SIDED|95.0|0.07|6.0|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.00|0.07|
91731839|NCT05796245|183358129|OTHER|Estimation|Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.08|6.61|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.61|0.08|
91493789|NCT04967443|182859113|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.87|||||TWO_SIDED|90.0|98.68|111.44|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||111.44|98.68|
91493790|NCT04967443|182859113|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.45|||||TWO_SIDED|90.0|99.58|109.55|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.55|99.58|
91701336|NCT04687072|183297500|OTHER||Difference in percentage|2.5|||||TWO_SIDED|95.0|-9.6|13.0|||||The 95% Agresti-Min CIs are presented.|||13.0|-9.6|
91701337|NCT04687072|183297503|SUPERIORITY||Location shift|0.0||||0.2929|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.2929
91701338|NCT04687072|183297504|SUPERIORITY||Location shift|0.0||||0.1475|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.1475
91701339|NCT04687072|183297505|SUPERIORITY||Location shift|0.0||||0.7677|TWO_SIDED|95.0|-2.0|2.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|WHO Classified Bleeding Event Grade ≥1||2.000|-2.000|0.7677
91493791|NCT04967443|182859114|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|113.96|||||TWO_SIDED|90.0|102.79|126.34|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||126.34|102.79|
91493792|NCT04967443|182859114|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|126.83|||||TWO_SIDED|90.0|114.32|140.7|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||140.70|114.32|
91513285|NCT01975389|182898133|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.029977|TWO_SIDED|95.0|0.57|0.97|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.57|0.029977
91513286|NCT01975389|182898134|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.162615|TWO_SIDED|95.0|0.14|1.44|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.44|0.14|0.162615
91513287|NCT01975389|182898135|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.051534|TWO_SIDED|95.0|0.59|1.0|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.00|0.59|0.051534
91513288|NCT01975389|182898136|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
91513289|NCT01975389|182898137|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.294331|TWO_SIDED|95.0|0.5|1.24|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.24|0.50|0.294331
91701340|NCT04687072|183297506|OTHER||Difference in percentage|-1.2|||||TWO_SIDED|95.0|-11.8|7.3|||||The 95% Agresti-Min CIs are presented.|IWG Complete Response||7.3|-11.8|
91701341|NCT04687072|183297506|OTHER||Difference in percentage|8.5|||||TWO_SIDED|95.0|-4.6|20.2|||||The 95% Agresti-Min CIs are presented.|IWG Response||20.2|-4.6|
91701342|NCT04687072|183297506|OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-9.7|13.3|||||The 95% Agresti-Min CIs are presented.|Initial Response||13.3|-9.7|
91701343|NCT04687072|183297508|OTHER||Difference in percentage|-4.0|||||TWO_SIDED|95.0|-15.6|5.7|||||The 95% Agresti-Min CIs are presented.|||5.7|-15.6|
91701344|NCT04545567|183297521|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91701345|NCT04545567|183297522|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91701346|NCT04545567|183297523|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91701347|NCT04545567|183297524|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91701348|NCT04545567|183297525|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91701349|NCT04545567|183297526|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
91701350|NCT04545567|183297527|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91701351|NCT04545567|183297528|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91701352|NCT04545567|183297529|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91701353|NCT04545567|183297530|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91701354|NCT04545567|183297531|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91701355|NCT04545567|183297532|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
91701356|NCT04545567|183297533|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
91701357|NCT04545567|183297534|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
91701358|NCT04545567|183297535|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91701359|NCT04545567|183297536|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91701360|NCT04545567|183297537|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91701361|NCT04545567|183297538|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91701362|NCT04545567|183297539|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
91701363|NCT04545567|183297540|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91701364|NCT03979807|183297541|OTHER||Adjusted Hazard Ratio|1.11|||||TWO_SIDED|95.0|1.06|1.17|||||Cox proportional hazard model. 'Treatment' is the only Independent variable used to estimate the hazard ratios. Umeclidinium/Vilanterol is Reference Group.|||1.17|1.06|
91731840|NCT05796245|183358129|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.1|0.21|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.21|-0.10|
91528719|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.47|||<|0.001|TWO_SIDED|95.0|1.29|1.68||1-sided|cLDA model||V116/PPSV23|Serotype 7F: V116/PPSV23 GMT Ratio||1.68|1.29|<0.001
91493793|NCT04967443|182859114|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|118.07|||||TWO_SIDED|90.0|106.46|130.94|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||130.94|106.46|
91493794|NCT04967443|182859115|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|100.91|||||TWO_SIDED|90.0|94.92|107.27|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||107.27|94.92|
91493795|NCT04967443|182859115|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|95.97|108.57|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.57|95.97|
91701365|NCT02754674|183297542|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
91701366|NCT02754674|183297543|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
91701367|NCT02754674|183297544|SUPERIORITY|Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.|||||>|0.05|||||||t-test, 2 sided|||We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson's Chi-square test or Fisher's exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.||||>0.05
91701368|NCT02754674|183297545|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91701369|NCT02754674|183297546|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
91701370|NCT03626363|183297553|SUPERIORITY|We sought to have up to 20 participants complete each group so that we could have a statistical power of 0.89 to detect about a 4 burst per minute difference with an alpha of 0.05. We would have had sympathetic nerve data on up to 18 more of the 21 participants that we were not allowed to post-test in the spring of 2020 due to COVID-19 restrictions.|Mean Difference (Net)|-2.0||||0.51|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in the mean number of bursts per minute of muscle sympathetic nerve activity (MSNA) from pre to post.||||0.51
91701371|NCT03626363|183297554|SUPERIORITY|To detect a 0.5 meter per second change in carotid-to-femoral pulse wave velocity with at least 80% power with an alpha of 0.05 we should have had at least 12 participants complete measurements in each group (MBSR and SME). We fell a little short of that in the MBSR group and met the 12 participants in the SME group. The number of participants we were able to study from pre to post was limited by COVID-19 restrictions.|Mean Difference (Net)|-0.2||||0.25|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in carotid-to-femoral pulse wave velocity in meters per second from pre to post. We had 21 participants in the spring of 2020 that were were not allowed to bring into the laboratory for post testing during COVID-19 restrictions which led to our limited sample size.||||0.25
91701372|NCT02100670|183297618|SUPERIORITY_OR_OTHER||Difference of LS mean|-9.23||||0.4144|TWO_SIDED|95.0|-31.45|12.98||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||12.98|-31.45|0.4144
91701373|NCT02100670|183297619|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.8761|TWO_SIDED|95.0|-18.34|21.5||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||21.50|-18.34|0.8761
91701374|NCT02100670|183297619|SUPERIORITY_OR_OTHER||LS mean difference|2.61||||0.8164|TWO_SIDED|95.0|-19.46|24.67||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||24.67|-19.46|0.8164
91701375|NCT02100670|183297619|SUPERIORITY_OR_OTHER||LS mean difference|1.03||||0.9279|TWO_SIDED|95.0|-21.27|23.33||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||23.33|-21.27|0.9279
91701376|NCT02100670|183297619|SUPERIORITY_OR_OTHER||LS mean difference|-10.81||||0.3442|TWO_SIDED|95.0|-33.26|11.64||P-value from multiple comparisons using t-test in Proc Mixed.|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||11.64|-33.26|0.3442
91493796|NCT04967443|182859115|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.04|||||TWO_SIDED|90.0|99.09|109.23|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.23|99.09|
91493797|NCT04502693|182859119|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE (Vaccine Effectiveness)|83.2|||||TWO_SIDED|97.5|81.9|84.4||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||84.4|81.9|
91493798|NCT04502693|182859119|OTHER|"Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_ 6 and the ACWY groups is above 65%.~VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage."|VE|81.8|||||TWO_SIDED|97.5|80.4|83.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB\_0\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||83.1|80.4|
91701377|NCT02100670|183297624|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.1||||0.5404|TWO_SIDED|95.0|0.81|1.48||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.48|0.81|0.5404
91701378|NCT02100670|183297624|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.9||||0.4639|TWO_SIDED|95.0|0.67|1.2||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.20|0.67|0.4639
91701379|NCT02100670|183297624|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.09||||0.5118|TWO_SIDED|95.0|0.84|1.43||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.84|0.5118
91701380|NCT02100670|183297625|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.93||||0.6918|TWO_SIDED|95.0|0.67|1.31||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.31|0.67|0.6918
91701381|NCT02100670|183297625|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.23||||0.2389|TWO_SIDED|95.0|0.87|1.73||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.73|0.87|0.2389
91701382|NCT02100670|183297625|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.0||||0.9817|TWO_SIDED|95.0|0.74|1.37||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.37|0.74|0.9817
91701383|NCT02100670|183297626|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.06||||0.7003|TWO_SIDED|95.0|0.79|1.43||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.79|0.7003
91701384|NCT02100670|183297626|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.01||||0.9565|TWO_SIDED|95.0|0.75|1.35||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.35|0.75|0.9565
91701385|NCT02100670|183297626|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.07||||0.6216|TWO_SIDED|95.0|0.82|1.4||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.40|0.82|0.6216
91701386|NCT02100670|183297630|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|2.43||||0.0408|TWO_SIDED|95.0|1.04|5.7||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||5.70|1.04|0.0408
91701387|NCT02100670|183297630|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.31||||0.4507|TWO_SIDED|95.0|0.65|2.65||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.65|0.65|0.4507
91701388|NCT02100670|183297630|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.38||||0.315|TWO_SIDED|95.0|0.73|2.61||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.61|0.73|0.3150
91701389|NCT01556997|183297636|SUPERIORITY_OR_OTHER|||||||0.025|ONE_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
91701390|NCT01556997|183297637|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
91731841|NCT05796245|183358129|OTHER|Estimation|Cox Proportional Hazard|2.07|||||TWO_SIDED|95.0|0.28|15.22|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.22|0.28|
91528720|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|1.04|1.32||1-sided|cLDA model||V116/PPSV23|Serotype 8: V116/PPSV23 GMT Ratio||1.32|1.04|<0.001
91528721|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.12|||<|0.001||95.0|1.0|1.26||1-sided|cLDA model||V116/PPSV23|Serotype 9N: V116/PPSV23 GMT Ratio||1.26|1.00|<0.001
91528722|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.37|1.77|||cLDA model||V116/PPSV23|Serotype 10A: V116/PPSV23 GMT Ratio||1.77|1.37|<0.001
91528723|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.05|||<|0.001||95.0|1.82|2.31|||cLDA model||V116/PPSV23|Serotype 11A: V116/PPSV23 GMT Ratio||2.31|1.82|<0.001
91731842|NCT05796245|183358129|OTHER|Estimation|Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.29|15.08|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.08|0.29|
91731843|NCT05796245|183358129|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.09|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.09|-0.05|
91731844|NCT03257657|183358147|OTHER|||||||0.1|||||||t-test, 2 sided|||||||0.1
91731845|NCT03257657|183358149|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
91528724|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.63|||<|0.001|TWO_SIDED|95.0|1.4|1.9|||cLDA model||V116/PPSV23|Serotype 12F: V116/PPSV23 GMT Ratio||1.90|1.40|<0.001
91731846|NCT03257657|183358151|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91731847|NCT02014467|183358161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|||<|0.0001|TWO_SIDED|95.0|3.67|5.18|||ANCOVA|||||5.18|3.67|<0.0001
91731848|NCT02014467|183358161|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.7495
91731849|NCT02014467|183358162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.21|||<|0.0001|TWO_SIDED|95.0|2.45|3.96|||ANCOVA|||||3.96|2.45|<0.0001
91731850|NCT02014467|183358162|SUPERIORITY_OR_OTHER|||||||0.9029||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.9029
91731851|NCT02014467|183358163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|||<|0.0001|TWO_SIDED|95.0|1.72|2.8|||ANCOVA|||||2.80|1.72|<0.0001
91528725|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.77|2.31|||cLDA model||V116/PPSV23|Serotype 17F: V116/PPSV23GMT Ratio||2.31|1.77|<0.001
91528726|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.42|||<|0.001|TWO_SIDED|95.0|1.26|1.6|||cLDA model||V116/PPSV23|Serotype 19A: V116/PPSV23 GMT Ratio||1.60|1.26|<0.001
91731852|NCT02014467|183358163|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.1070
91731853|NCT02014467|183358164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.59|||<|0.0001|TWO_SIDED|95.0|0.98|2.2|||ANCOVA|||||2.20|0.98|<0.0001
91731854|NCT02014467|183358164|SUPERIORITY_OR_OTHER|||||||0.4369||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.4369
91731855|NCT02014467|183358165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.0001||95.0|2.39|4.32|||ANCOVA|||||4.32|2.39|<0.0001
91731856|NCT02014467|183358165|SUPERIORITY_OR_OTHER|||||||0.6082||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.6082
91731857|NCT02014467|183358166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.31|||<|0.0001|TWO_SIDED|95.0|2.74|3.88|||ANCOVA|||||3.88|2.74|<0.0001
91731858|NCT02014467|183358166|SUPERIORITY_OR_OTHER|||||||0.3513||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3513
91731859|NCT02014467|183358167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|||<|0.0001|TWO_SIDED|95.0|1.96|3.27|||ANCOVA|||||3.27|1.96|<0.0001
91731860|NCT02014467|183358167|SUPERIORITY_OR_OTHER|||||||0.541||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.5410
91731861|NCT02014467|183358168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.72|||<|0.0001|TWO_SIDED|95.0|3.71|5.72|||ANCOVA|||||5.72|3.71|<0.0001
91731862|NCT02014467|183358168|SUPERIORITY_OR_OTHER|||||||0.3957||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3957
91701391|NCT05459558|183297638|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
91528727|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.46|1.88|||cLDA model||V116/PPSV23|Serotype 20A: V116/PPSV23 GMT Ratio||1.88|1.46|<0.001
91528728|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.53|||<|0.001|TWO_SIDED|95.0|1.34|1.75|||cLDA model||V116/PPSV23|Serotype 22F: V116/PPSV23 GMT Ratio||1.75|1.34|<0.001
91701392|NCT05459558|183297638|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
91701393|NCT05459558|183297639|SUPERIORITY||||||<|0.0001|||||||Mixed Models with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
91701394|NCT05459558|183297639|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
91701395|NCT05459558|183297640|SUPERIORITY||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.88|-1.62|||Mixed Model with Repeated Measures|||Week 4||-1.62|-1.88|<0.0001
91701396|NCT05459558|183297640|SUPERIORITY||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.87|-1.61|||Mixed Model with Repeated Measures|||Week 4||-1.61|-1.87|<0.0001
91701397|NCT05459558|183297640|SUPERIORITY||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.08|-1.81||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.81|-2.08|<0.0001
91701398|NCT05459558|183297640|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.18|-1.9||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.90|-2.18|<0.0001
91701399|NCT05459558|183297641|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||Mixed Model with Repeated Measures|||Week 4||-0.62|-1.00|<0.0001
91701400|NCT05459558|183297641|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41|||Mixed Model with Repeated Measures|||Week 4||-0.41|-0.79|<0.0001
91701401|NCT05459558|183297641|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.06|-1.31||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.31|-2.06|<0.0001
91701402|NCT05459558|183297641|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-2.19|-1.44||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.44|-2.19|<0.0001
91701403|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
91701404|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
91701405|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.69|-2.31|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.31|-2.69|<0.0001
91701406|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.81|-2.44|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.44|-2.81|<0.0001
91701407|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.22|-1.91|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.91|-2.22|<0.0001
91701408|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.2|-1.89|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.89|-2.20|<0.0001
91701409|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-2.45|-2.13|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.13|-2.45|<0.0001
91701410|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001|TWO_SIDED|95.0|-2.57|-2.25|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.25|-2.57|<0.0001
91701411|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.76|-0.5|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.50|-0.76|<0.0001
91701412|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.77|-0.51|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.51|-0.77|<0.0001
91701413|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
91701414|NCT05459558|183297642|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
91701415|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.97|-0.82|||Mixed Model with Repeated Measures|||Area, Week 4||-0.82|-0.97|<0.0001
91701416|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.95|-0.79|||Mixed Model with Repeated Measures|||Area, Week 4||-0.79|-0.95|<0.0001
91701417|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.15|-1.01|||Mixed Model with Repeated Measures|||Area, Week 8||-1.01|-1.15|<0.0001
91701418|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.22|-1.07|||Mixed Model with Repeated Measures|||Area, Week 8||-1.07|-1.22|<0.0001
91701419|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
91528729|NCT05569954|182933492|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||cLDA model||V116/PPSV23|Serotype 33F: V116/PPSV23 GMT Ratio||1.04|0.76|<0.001
91731863|NCT02014467|183358169|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.92|||<|0.0001|TWO_SIDED|95.0|-61.38|-52.65||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 6|||-52.65|-61.38|<0.0001
91731864|NCT02014467|183358169|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-52.56|||<|0.0001||95.0|-59.38|-46.17||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 12|||-46.17|-59.38|<0.0001
91731865|NCT02014467|183358170|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.94|||<|0.0001|TWO_SIDED|95.0|-61.6|-52.7||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 6|||-52.70|-61.60|<0.0001
91731866|NCT02014467|183358170|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-51.21|||<|0.0001|TWO_SIDED|95.0|-56.26|-45.91||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 12|||-45.91|-56.26|<0.0001
91731867|NCT01217892|183358195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.084||0.0106|TWO_SIDED|95.0|-0.38|-0.05||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.05|-0.38|0.0106
91528730|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.31|||<|0.001|TWO_SIDED|95.0|2.84|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 6A: V116/PPSV23 GMT Ratio||3.87|2.84|<0.001
91528731|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.61|||<|0.001|TWO_SIDED|95.0|3.99|5.33||1-sided|cLDA model||V116/PPSV23|Serotype 15A: V116/PPSV23 GMT Ratio||5.33|3.99|<0.001
91528732|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|2.92|||<|0.001||95.0|2.5|3.42||1-sided|cLDA model||V116/PPSV23|Serotype 15C: V116/PPSV23 GMT Ratio||3.42|2.50|<0.001
91731868|NCT01217892|183358195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0843|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.18|-0.52|<0.0001
91731869|NCT01217892|183358196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.363|<|0.0001|TWO_SIDED|95.0|-2.53|-1.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.10|-2.53|<0.0001
91731870|NCT01217892|183358196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.3636|<|0.0001|TWO_SIDED|95.0|-2.89|-1.46||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.46|-2.89|<0.0001
91731871|NCT01217892|183358197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|3.04|<|0.0001|TWO_SIDED|95.0|-21.7|-9.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.7|-21.7|<0.0001
91528733|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.5|||<|0.001|TWO_SIDED|95.0|3.99|5.09||1-sided|cLDA model||V116/PPSV23|Serotype 16F: V116/PPSV23 GMT Ratio||5.09|3.99|<0.001
91731872|NCT01217892|183358197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|STANDARD_ERROR_OF_MEAN|3.039|<|0.0001|TWO_SIDED|95.0|-22.7|-10.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-10.7|-22.7|<0.0001
91731873|NCT01217892|183358198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.132||0.001|TWO_SIDED|95.0|-16.5|-4.2||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-4.2|-16.5|0.0010
91731874|NCT01217892|183358198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|3.139|<|0.0001|TWO_SIDED|95.0|-21.4|-9.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.1|-21.4|<0.0001
91731875|NCT01217892|183358199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|6.097||0.0455|TWO_SIDED|95.0|0.2|24.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||24.1|0.2|0.0455
91701420|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
91701421|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.04|-0.9|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.90|-1.04|<0.0001
91701422|NCT05459558|183297643|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.08|-0.95|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.95|-1.08|<0.0001
91731876|NCT01217892|183358199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.8|STANDARD_ERROR_OF_MEAN|6.153||0.0062|TWO_SIDED|95.0|4.8|28.9||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||28.9|4.8|0.0062
91731877|NCT00831389|183358201|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.||||0.791
91731878|NCT00831389|183358202|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.||||0.5
91731879|NCT00831389|183358203|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.||||0.25
91493799|NCT04502693|182859120|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|78.7|||||TWO_SIDED|97.5|77.2|80.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||80.1|77.2|
91701423|NCT05175131|183297684|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.0042|TWO_SIDED|95.0|0.3|1.8|||ANCOVA||Mean difference of Mebeverine+Simethicone combination to Mebeverine. Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||1.8|0.3|0.0042
91701424|NCT05175131|183297684|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.0001|TWO_SIDED|95.0|0.9|2.4|||ANCOVA||Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|Mean difference of Mebeverine+Simethicone combination to Simethicone. ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||2.4|0.9|<0.0001
91701425|NCT05711381|183297689|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.59|1.41||||||||1.41|0.59|
91493800|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.10|0.84|
91493801|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.75|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||0.98|0.75|
91493802|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.78|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.02|0.78|
91493803|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.92|||||TWO_SIDED|95.0|0.76|1.11||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.11|0.76|
91493804|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.41|0.97|
91493805|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.27|||||TWO_SIDED|95.0|1.05|1.54||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.54|1.05|
91493806|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
91493807|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
91493808|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.86|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.14|0.86|
91493809|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.73|1.01||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.01|0.73|
91493810|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||0.98|0.71|
91513290|NCT01975389|182898139|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
91528734|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|5.74|||<|0.001|TWO_SIDED|95.0|4.81|6.85||1-sided|cLDA model||V116/PPSV23|Serotype 23A: V116/PPSV23 GMT Ratio||6.85|4.81|<0.001
91731880|NCT00831389|183358204|SUPERIORITY_OR_OTHER|||||||0.0669||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.||||0.0669
91731881|NCT00831389|183358205|SUPERIORITY_OR_OTHER|||||||0.2256||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.||||0.2256
91731882|NCT00831389|183358206|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.||||0.791
91731883|NCT00831389|183358207|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.||||0.2036
91731884|NCT00831389|183358208|SUPERIORITY_OR_OTHER|||||||0.6221||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.||||0.6221
91731885|NCT00831389|183358209|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.||||0.021
91731886|NCT00831389|183358210|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.||||0.0176
91731887|NCT01592747|183358251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.659|TWO_SIDED|95.0|0.7|1.8|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. memantine full dose.||1.8|0.7|0.6590
91731888|NCT01592747|183358251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7839|TWO_SIDED|95.0|0.7|1.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. Memantine reduced dose||1.7|0.7|0.7839
91731889|NCT01592747|183358253|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.8136|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.8136
91493811|NCT04502693|182859123|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.82|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.14|0.82|
91513291|NCT01975389|182898140|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6012|TWO_SIDED|95.0|0.6|1.34|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.34|0.60|0.601200
91731890|NCT01592747|183358253|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9244|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.9244
91731891|NCT01592747|183358254|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.7611|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.7611
91731892|NCT01592747|183358254|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3176|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3176
91731893|NCT01592747|183358255|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.902|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.9020
91731894|NCT01592747|183358255|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.1279|TWO_SIDED|95.0|-0.1|1.0|||ANCOVA|||||1.0|-0.1|0.1279
91731895|NCT01592747|183358256|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4144|TWO_SIDED|95.0|-0.4|1.1|||ANCOVA|||||1.1|-0.4|0.4144
91731896|NCT01592747|183358256|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4212|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4212
91731897|NCT01592747|183358257|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6238|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.6238
91731898|NCT01592747|183358257|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.5957|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||||0.9|-0.5|0.5957
91731899|NCT01592747|183358258|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.864|TWO_SIDED|95.0|-0.6|0.7|||ANCOVA|||||0.7|-0.6|0.8640
91731900|NCT01592747|183358258|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4362|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.4362
91731901|NCT01592747|183358259|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.7182|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.7182
91731902|NCT01592747|183358259|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.839|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.8390
91731903|NCT01592747|183358260|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||0.0813|TWO_SIDED|95.0|-0.1|1.4|||ANCOVA|||||1.4|-0.1|0.0813
91731904|NCT01592747|183358260|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4365|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4365
91731905|NCT01592747|183358261|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4213|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4213
91731906|NCT01592747|183358261|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4267|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4267
91731907|NCT01592747|183358262|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3713||95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.3713
91731908|NCT01592747|183358262|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.2855|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.2855
91731909|NCT00456365|183358342|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
91731910|NCT00456365|183358343|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
91731911|NCT00456365|183358344|SUPERIORITY_OR_OTHER|||||||0.69|||||||ANOVA|||||||0.69
91731912|NCT00456365|183358345|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||||||0.21
91493812|NCT04502693|182859124|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|11.29|||||TWO_SIDED|95.0|5.88|19.01|||Difference in percentage of participants|||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||19.01|5.88|
91701426|NCT05711381|183297690|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|1.25|||||TWO_SIDED|90.0|0.93|1.68||||||||1.68|0.93|
91493813|NCT04502693|182859124|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|47.22|||||TWO_SIDED|95.0|38.14|56.3||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||56.30|38.14|
91493814|NCT04502693|182859124|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|35.31|||||TWO_SIDED|95.0|26.88|44.49||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||44.49|26.88|
91701427|NCT01892085|183297722|SUPERIORITY|||||||0.015|||||||Marginalized two part model|||||||0.015
91701428|NCT01892085|183297722|SUPERIORITY|||||||0.339|||||||Marginalized two part model|||||||0.339
91731913|NCT00928720|183358346|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
91731914|NCT00721110|183358364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.96|TWO_SIDED|97.5|-52.0|54.0||Significant if P \< 0.003 for efficacy and P \> 0.5311 for futility; 97.5% confidence intervals adjusted for group sequential design to maintain the overall alpha of 0.025 for each primary intervention.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||54|-52|0.96
91731915|NCT00721110|183358364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.54|TWO_SIDED|97.5|-65.0|44.0||97.5% confidence interval adjusted for group sequential design (using confidence coefficient of 2.97) to maintain theoverall α of 0.025 for each primary intervention and 0.05 for the trial.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||44|-65|0.54
91731916|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.2|TWO_SIDED|97.5|-3.3|1.3||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Groups compared on VRS scores at PACU admit using a t test.||1.3|-3.3|0.20
91701429|NCT01892085|183297723|SUPERIORITY|||||||0.024|||||||Marginalized two part model|||||||0.024
91701430|NCT01892085|183297723|SUPERIORITY|||||||0.317|||||||Marginalized two part model|||||||0.317
91701431|NCT01892085|183297724|SUPERIORITY|||||||0.031|||||||Marginalized two part model|||||||0.031
91731917|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.54|TWO_SIDED|97.5|-2.8|1.9||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine compared to placebo at PACU admit using a t test||1.9|-2.8|0.54
91731918|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.11|TWO_SIDED|97.5|-2.5|0.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.||0.8|-2.5|0.11
91731919|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.56|TWO_SIDED|97.5|-1.4|2.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.||2.0|-1.4|0.56
91701432|NCT01892085|183297724|SUPERIORITY|||||||0.298|||||||Marginalized two part model|||||||0.298
91701433|NCT01892085|183297725|SUPERIORITY|||||||0.05|||||||Marginalized two part model|||||||0.05
91701434|NCT01892085|183297725|SUPERIORITY|||||||0.27|||||||Marginalized 2 part model|||||||0.27
91701435|NCT01892085|183297726|SUPERIORITY|||||||0.069|||||||Marginalized two part model|||||||0.069
91701436|NCT01892085|183297726|SUPERIORITY|||||||0.244|||||||Marginalized two part model|||||||0.244
91701437|NCT01892085|183297727|SUPERIORITY|||||||0.094|||||||Marginalized two part model|||||||0.094
91701438|NCT01892085|183297727|SUPERIORITY|||||||0.235|||||||Marginalized 2 part model|||||||0.235
91701439|NCT01892085|183297728|SUPERIORITY|||||||0.123|||||||Marginalized two part model|||||||0.123
91701440|NCT01892085|183297728|SUPERIORITY|||||||0.21|||||||Marginalized two part model|||||||0.210
91701441|NCT01892085|183297729|SUPERIORITY|||||||0.143|||||||Marginalized two part model|||||||0.143
91701442|NCT01892085|183297729|SUPERIORITY|||||||0.196|||||||Marginalized two part model|||||||0.196
91701443|NCT01892085|183297730|SUPERIORITY|||||||0.185|||||||Marginalized two part model|||||||0.185
91701444|NCT01892085|183297730|SUPERIORITY|||||||0.183|||||||Marginalized two part model|||||||0.183
91701445|NCT01892085|183297731|SUPERIORITY|||||||0.229|||||||Marginalized two part model|||||||0.229
91701446|NCT01892085|183297731|SUPERIORITY|||||||0.17|||||||Marginalized two part model|||||||0.170
91701447|NCT01892085|183297732|SUPERIORITY|||||||0.314|||||||Marginalized two part model|||||||0.314
91701448|NCT01892085|183297732|SUPERIORITY|||||||0.162|||||||Marginalized two part model|||||||0.162
91701449|NCT01892085|183297733|SUPERIORITY|||||||0.377|||||||Marginalized two part model|||||||0.377
91701450|NCT01892085|183297733|SUPERIORITY|||||||0.149|||||||Marginalized two part model|||||||0.149
91701451|NCT01892085|183297734|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
91701452|NCT01892085|183297735|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
91701453|NCT01892085|183297736|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||00.22
91701454|NCT01892085|183297737|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
91701455|NCT01892085|183297738|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
91701456|NCT01892085|183297739|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
91701457|NCT01892085|183297740|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
91701458|NCT01892085|183297741|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
91701459|NCT01892085|183297742|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
91701460|NCT01472757|183297743|SUPERIORITY|||||||0.013|||||||ANCOVA|||||||0.013
91701461|NCT01472757|183297743|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
91701462|NCT01472757|183297743|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
91701463|NCT01472757|183297744|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
91701464|NCT01472757|183297744|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
91701465|NCT01472757|183297744|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
91701466|NCT01472757|183297745|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91701467|NCT01472757|183297745|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91701468|NCT01472757|183297745|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
91701469|NCT00480493|183297764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|3.36||0.468|TWO_SIDED|95.0|-4.32|9.24|||t-test, 2 sided||Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.||9.24|-4.32|0.468
91701470|NCT00480493|183297765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82|STANDARD_ERROR_OF_MEAN|10.05||0.634|TWO_SIDED|95.0|-15.47|25.11|||t-test, 2 sided||Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.||25.11|-15.47|0.634
91701471|NCT00480493|183297766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|3.12||0.43|TWO_SIDED|95.0|-8.76|3.8|||t-test, 2 sided||We also used a random-effect, mixed regression models to look for between group changes over time.|The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.||3.80|-8.76|0.430
91701472|NCT03747302|183297767|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
91701473|NCT03747302|183297768|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Change in mean scores for behavioral intent to vaccine: negative values: smaller values indicate more likely to vaccinate.||||>.05
91701474|NCT00738062|183297792|SUPERIORITY_OR_OTHER|||||||0.438|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.438
91701475|NCT00738062|183297793|SUPERIORITY_OR_OTHER|||||||0.554|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.||||||0.554
91701476|NCT00738062|183297794|SUPERIORITY_OR_OTHER|||||||0.198|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.||||||0.198
91701477|NCT00738062|183297795|SUPERIORITY_OR_OTHER|||||||0.286|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.286
91701478|NCT00738062|183297796|SUPERIORITY_OR_OTHER|||||||0.251|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.251
91701479|NCT00738062|183297797|SUPERIORITY_OR_OTHER|||||||0.708|||||||Fisher Exact|||||||0.708
91701480|NCT00738062|183297798|SUPERIORITY_OR_OTHER|||||||0.873|||||||Fisher Exact|||||||0.873
91701481|NCT00738062|183297799|SUPERIORITY_OR_OTHER|||||||0.252|||||||Fisher Exact|||||||0.252
91701482|NCT00738062|183297800|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.330
91701483|NCT00033657|183297814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED|95.0|||||Log Rank|||||||0.48
91701484|NCT01683422|183297816|SUPERIORITY|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||||0.1|||||||t-test, 1 sided|||In the RTOG 9812 (NCT00003591) for unresectable pancreatic cancer, a one-year survival rate of 43% was observed. There were 109 analyzable patients on NCT00003591 with 61 still at risk for death at one year. Using the method of Dixon and Simon, a sample size of 39 analyzable patients followed over 12 months will ensure at least 90% probability of detecting a minimum of 17% improvement in the one-year survival rate compared to NCT00003591 at the 0.10 significance level (with a one-sided test).||||0.1
91493815|NCT04502693|182859124|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|26.99|||||TWO_SIDED|95.0|19.38|35.81||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||35.81|19.38|
91493816|NCT04502693|182859125|OTHER|Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY\_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|77.9|||||TWO_SIDED|95.0|76.6|79.2||||||To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.||79.2|76.6|
91528735|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|16.42|||<|0.001|TWO_SIDED|95.0|13.46|20.03||1-sided|cLDA model||V116/PPSV23|Serotype 23B: V116/PPSV23 GMT Ratio||20.03|13.46|<0.001
91528736|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.39|||<|0.001||95.0|2.97|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 24F: V116/PPSV23 GMT Ratio||3.87|2.97|<0.001
91528737|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|11.89|||<|0.001|TWO_SIDED|95.0|10.16|13.91||1-sided|cLDA model||V116/PPSV23|Serotype 31: V116/PPSV23 GMT Ratio||13.91|10.16|<0.001
91701485|NCT01225289|183297835|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91701486|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.12|||||TWO_SIDED|95.0|1.0|1.24||||||||1.24|1|
91701487|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.05|||||TWO_SIDED|95.0|0.95|1.17||||||||1.17|0.95|
91701488|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
91701489|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
91701490|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.99|||||TWO_SIDED|95.0|0.9|1.08||||||||1.08|0.9|
91701491|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.89|1.07||||||||1.07|0.89|
91701492|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.1|0.91|
91701493|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
91701494|NCT01162122|183297839|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
91701495|NCT01162122|183297840|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|1.32|1.49||||||||1.49|1.32|
91701496|NCT01162122|183297840|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.61|||||TWO_SIDED|95.0|1.52|1.7||||||||1.7|1.52|
91701497|NCT01162122|183297840|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.15|||||TWO_SIDED|95.0|1.08|1.21||||||||1.21|1.08|
91701498|NCT01162122|183297841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H1N1 strain)|9.2|||||TWO_SIDED|95.0|7.1|11.3||||||||11.3|7.1|
91701499|NCT01162122|183297841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.5|14.9||||||||14.9|10.5|
91701500|NCT01162122|183297841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (B strain)|5.2|||||TWO_SIDED|95.0|3.0|7.4||||||||7.4|3.0|
91701501|NCT01162122|183297842|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.37|||||TWO_SIDED|95.0|1.29|1.46||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.46|1.29|
91701502|NCT01162122|183297842|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.51|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.51|
91701503|NCT01162122|183297842|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.14|||||TWO_SIDED|95.0|1.08|1.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.2|1.08|
91701504|NCT01162122|183297843|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|8.9|||||TWO_SIDED|95.0|6.9|10.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||10.9|6.9|
91493817|NCT04502693|182859126|NON_INFERIORITY|Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.|Difference in percentage of participants|-0.61|||||TWO_SIDED|95.0|-1.25|0.03||||||To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.||0.03|-1.25|
91493818|NCT00279305|182859158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.104||0.05|TWO_SIDED|95.0|-0.0699|0.348|||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||0.348|-0.0699|0.05
91493819|NCT04404361|182859159|SUPERIORITY||Risk Difference (RD)|1.51||||0.8516|TWO_SIDED|95.0|-10.55|13.53|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5).||||13.53|-10.55|0.8516
91493820|NCT04404361|182859160|SUPERIORITY|||||||0.7494|||||||Wilcoxon (Mann-Whitney)|||||||0.7494
91493821|NCT04404361|182859161|SUPERIORITY||Odds Ratio (OR)|1.29||||0.6323|TWO_SIDED|95.0|0.46|3.58|||Cochran-Mantel-Haenszel||OR from a CMH test stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||3.58|0.46|0.6323
91493822|NCT04404361|182859162|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7541|TWO_SIDED|95.0|0.31|4.96|||Cochran-Mantel-Haenszel||OR from a CMH test Stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||4.96|0.31|0.7541
91493823|NCT04404361|182859163|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5666|TWO_SIDED|95.0|0.79|1.53||"log-rank test stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS"|Log Rank|"stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)"|estimated using a stratified Cox proportional hazards model stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)|||1.53|0.79|0.5666
91493824|NCT04404361|182859165|SUPERIORITY||Odds Ratio (OR)|2.46||||0.2722|TWO_SIDED|95.0|0.47|12.93|||Chi-squared|||||12.93|0.47|0.2722
91493825|NCT03307967|182859185|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum||||||.07
91528738|NCT05569954|182933492|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.54|6.87||1-sided|cLDA model||V116/PPSV23|Serotype 35B: V116/PPSV23 GMT Ratio||6.87|5.54|<0.001
91493826|NCT03307967|182859186|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum Test||||||.98
91701505|NCT01162122|183297843|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.6|14.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||14.8|10.6|
91701506|NCT01162122|183297843|SUPERIORITY_OR_OTHER||Group difference (B strain)|5.1|||||TWO_SIDED|95.0|2.9|7.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||7.2|2.9|
91493827|NCT02166905|182859227|OTHER||Hazard Ratio (HR)|0.4||||0.177|TWO_SIDED|90.0|0.1|1.2|||Log Rank||Reference=arm 1|||1.2|0.1|0.177
91701507|NCT01162122|183297847|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||||1.52|1.25|
91759177|NCT04038567|183411373|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.42|-0.40|
91493828|NCT02617628|182859233|EQUIVALENCE|The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.|Odds Ratio (OR)|1.56||||0.38|TWO_SIDED|95.0|0.57|4.27|||Regression, Logistic||Threshold for significance was set at p\<.05|Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.||4.27|0.57|0.38
91493829|NCT02617628|182859234|SUPERIORITY||Cox Proportional Hazard|-0.74486||||0.01|TWO_SIDED|95.0|||||Regression, Cox|||We used Cox proportional hazards regression model to compare the groups on time to reincarceration.||||0.01
91701508|NCT01162122|183297847|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.57|||||TWO_SIDED|95.0|1.44|1.72||||||||1.72|1.44|
91701509|NCT01162122|183297847|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.12|||||TWO_SIDED|95.0|1.03|1.21||||||||1.21|1.03|
91701510|NCT01162122|183297848|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H1N1 strain)|11.1|||||TWO_SIDED|95.0|7.5|14.6||||||||14.6|7.5|
91493830|NCT02065375|182859235|SUPERIORITY||Difference in proportion of patients|-1.2||||0.4543|TWO_SIDED|95.0|-21.3|18.9|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||18.9|-21.3|0.4543
91528739|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|26.0|||<|0.001|TWO_SIDED|95.0|20.9|31.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 6A: V116-PPSV23 Percentage Difference||31.0|20.9|<0.001
91528740|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|39.4|||<|0.001|TWO_SIDED|95.0|33.6|44.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15A: V116-PPSV23 Percentage Difference||44.8|33.6|<0.001
91731920|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.2|TWO_SIDED|97.5|-0.9|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.||2.2|-0.9|0.20
91731921|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|97.5|-1.4|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.||1.7|-1.4|0.79
91731922|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|97.5|-1.1|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.||1.7|-1.1|0.55
91493831|NCT02065375|182859235|SUPERIORITY||Difference in proportion of patients|8.2||||0.2297|TWO_SIDED|95.0|-13.5|29.8|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||29.8|-13.5|0.2297
91701511|NCT01162122|183297848|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H3N2 strain)|13.5|||||TWO_SIDED|95.0|9.8|17.2||||||||17.2|9.8|
91701512|NCT01162122|183297848|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (B strain)|5.0|||||TWO_SIDED|95.0|1.4|8.5||||||||8.5|1.4|
91701513|NCT01162122|183297849|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.32|||||TWO_SIDED|95.0|1.2|1.45||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.45|1.2|
91701514|NCT01162122|183297849|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.42|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.42|
91701515|NCT01162122|183297849|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.11|||||TWO_SIDED|95.0|1.03|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.21|1.03|
91731923|NCT00721110|183358365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.47|TWO_SIDED|97.5|-1.1|1.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.||1.8|-1.1|0.47
91731924|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.63|TWO_SIDED|97.5|-7.0|7.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.||7|-7|0.63
91701516|NCT01162122|183297853|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.9|||||TWO_SIDED|95.0|6.4|13.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||13.3|6.4|
91701517|NCT01162122|183297853|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|13.0|||||TWO_SIDED|95.0|9.5|16.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||16.6|9.5|
91701518|NCT01162122|183297853|SUPERIORITY_OR_OTHER||Group difference (B strain)|4.9|||||TWO_SIDED|95.0|1.5|8.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||8.3|1.5|
91701519|NCT01162122|183297854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Brisbane-overall)|1.45|||||TWO_SIDED|95.0|1.29|1.63||||||||1.63|1.29|
91701520|NCT01162122|183297854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Wisconsin-overall)|1.36|||||TWO_SIDED|95.0|1.23|1.5||||||||1.5|1.23|
91701521|NCT01162122|183297854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.|GMT Ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.98|1.21||||||||1.21|0.98|
91493832|NCT02065375|182859236|SUPERIORITY||Difference in proportion of patients|-21.6||||0.028|TWO_SIDED|95.0|-43.1|0.0|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||0.00|-43.1|.0280
91731925|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.0||||0.27|TWO_SIDED|97.5|-10.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.||5|-10|0.27
91493833|NCT02065375|182859236|SUPERIORITY||Difference in proportion of patients|-24.0||||0.0192|TWO_SIDED|95.0|-45.8|-2.2|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||-2.2|-45.8|0.0192
91493834|NCT02801331|182859327|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A chi squared test of proportions was used for unadjusted comparisons.||||||0.6||||||Unadjusted|Chi-squared|||||||.60
91493835|NCT02801331|182859328|EQUIVALENCE|A statistical test comparing cumulative morphine dose was performed for the cohort that was treated with morphine (n=60)||||||0.62|||||||t-test, 2 sided|degrees of freedom =58 for cohort analyzed that received morphine treatment.||||||.62
91493836|NCT02801331|182859329|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants who completed hospitalization at study site (n=181).||||||0.29|||||||t-test, 2 sided|df = 179 based on number of infants who completed hospitalization at study site.||||||0.29
91493837|NCT02801331|182859330|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants (n=121)||||||0.55|||||||t-test, 2 sided|df = 119 based on number of infants who did not receive morphine treatment.||||||0.55
91493838|NCT02801331|182859331|EQUIVALENCE|A statistical test comparing day of life discharged among treated infants, n=60||||||0.36|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.36
91493839|NCT02801331|182859332|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A t test of means was used for unadjusted comparisons.||||||0.56|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.56
91493840|NCT02801331|182859333|EQUIVALENCE|A statistical test comparing day of life infant started treatment as performed for the cohort that was treated with morphine (n=60)||||||0.25|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.25
91493841|NCT02443987|182859337|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
91493842|NCT02443987|182859338|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91731926|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.28|TWO_SIDED|97.5|-15.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||5|-15|0.28
91493843|NCT02443987|182859339|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91493844|NCT02443987|182859340|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
91493845|NCT02513394|182859344|OTHER||Hazard Ratio (HR)|0.96||||0.65|TWO_SIDED|95.0|0.81|1.14|||Log Rank||This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).|||1.14|0.81|0.65
91493846|NCT02513394|182859345|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.82|1.19||||||||1.19|0.82|
91493847|NCT02513394|182859346|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.87|1.28||||||||1.28|0.87|
91493848|NCT02513394|182859347|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.98|1.78||||||||1.78|0.98|
91493849|NCT02513394|182859348|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.57|1.23||||||||1.23|0.57|
91528741|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|11.7||||0.214|TWO_SIDED|95.0|7.5|15.9||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15C: V116-PPSV23 Percentage Difference||15.9|7.5|0.214
91493850|NCT03633695|182859355|SUPERIORITY||Mean Difference (Final Values)|-0.177|||<|0.0001|TWO_SIDED|95.0|-0.214|-0.14||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.140|-0.214|<.0001
91493851|NCT03633695|182859356|SUPERIORITY||Mean Difference (Final Values)|-0.191|||<|0.0001|TWO_SIDED|95.0|-0.223|-0.158||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.158|-0.223|<.0001
91493852|NCT03633695|182859357|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|-0.012|||<|0.0001|ONE_SIDED|95.0||0.007||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.||0.007||<.0001
91493853|NCT03633695|182859358|SUPERIORITY||Mean Difference (Final Values)|-0.18|||<|0.0001|TWO_SIDED|95.0|-0.198|-0.163||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 IOL Eye (IC-8 IOL Group) - Fellow Eye (IC-8 IOL Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.||-0.163|-0.198|<.0001
91493854|NCT03633695|182859359|OTHER||Difference in depth of focus|0.91|||||TWO_SIDED||||||||Difference in depth of focus \[IC-8™ IOL Eyes (IC-8™ IOL Group) - Fellow Eyes (IC-8™ IOL Group)\]|||||
91493855|NCT03633695|182859360|NON_INFERIORITY|The non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|0.068|||<|0.0001|ONE_SIDED|95.0||0.082||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Eyes (IC-8 Group) - Fellow Eyes (IC-8 Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.||0.082||<.0001
91493856|NCT03633695|182859368|NON_INFERIORITY|Non-inferiority margin was 0.12 logMAR.|Mean Difference (Final Values)|0.023|||<|0.0001|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05.|t-test, 1 sided|||The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.||||<.0001
91701522|NCT01162122|183297854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Brisbane-high risk group)|1.35||||||95.0|1.13|1.61||||||||1.61|1.13|
91701523|NCT01162122|183297854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Wisconsin-high risk group|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||||1.5|1.1|
91701524|NCT01162122|183297854|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (B strain-high risk group)|1.11|||||TWO_SIDED|95.0|0.95|1.3||||||||1.3|0.95|
91731927|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.22|TWO_SIDED|97.5|-15.0|4.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||4|-15|0.22
91731928|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.76|TWO_SIDED|97.5|-13.0|21.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||21|-13|0.76
91731929|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.66|TWO_SIDED|97.5|-19.0|14.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||14|-19|0.66
91731930|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.3|TWO_SIDED|97.5|-5.0|10.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||10|-5|0.30
91731931|NCT00721110|183358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|97.5|-5.0|8.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||8|-5|0.79
91493857|NCT05426902|182859383|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
91731932|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.58|TWO_SIDED|97.5|-0.28|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||numerator: lidocaine; denominator: control|Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.41|-0.28|0.58
91731933|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.02||||0.87|TWO_SIDED|97.5|-0.32|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||Numinator: ketamine; denominator: nonketamine|Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.36|-0.32|0.87
91731934|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.61|TWO_SIDED|97.5|-0.31|0.44||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.||0.44|-0.31|0.61
91701525|NCT01162122|183297855|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-overall)|1.49|||||TWO_SIDED|95.0|1.33|1.67||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.67|1.33|
91701526|NCT01162122|183297855|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-overall)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.52|1.25|
91701527|NCT01162122|183297855|SUPERIORITY_OR_OTHER||GMT ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.21|0.99|
91701528|NCT01162122|183297855|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-high risk)|1.36|||||TWO_SIDED|95.0|1.15|1.61||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.61|1.15|
91701529|NCT01162122|183297855|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-high risk)|1.28|||||TWO_SIDED|95.0|1.1|1.48||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.48|1.1|
91701530|NCT01162122|183297855|SUPERIORITY_OR_OTHER||GMT ratio (B strain-high risk)|1.13|||||TWO_SIDED|95.0|0.97|1.31||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.31|0.97|
91701531|NCT01162122|183297856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (H3N2/Brisbane-overall)|11.3|||||TWO_SIDED|95.0|6.7|15.9||||||||15.9|6.7|
91701532|NCT01162122|183297856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Wisconsin-overall)|11.9|||||TWO_SIDED|95.0|7.3|16.6||||||||16.6|7.3|
91701533|NCT01162122|183297856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Slope|4.0|||||TWO_SIDED|95.0|-0.4|8.4||||||||8.4|-0.4|
91701534|NCT01162122|183297856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Brisbane-high risk|12.3|||||TWO_SIDED|95.0|4.8|19.9||||||||19.9|4.8|
91701535|NCT01162122|183297856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference(H3N2Wisconsin-high risk|12.6|||||TWO_SIDED|95.0|5.0|20.2||||||||20.2|5.0|
91701536|NCT01162122|183297856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (B strain-high risk)|4.8|||||TWO_SIDED|95.0|-2.1|11.8||||||||11.8|-2.1|
91701537|NCT01162122|183297857|SUPERIORITY_OR_OTHER||Group difference (H3N2/Brisbane-overall)|12.5|||||TWO_SIDED|95.0|8.1|16.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||16.9|8.1|
91701538|NCT01162122|183297857|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-overall)|12.6|||||TWO_SIDED|95.0|8.1|17.1||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||17.1|8.1|
91701539|NCT01162122|183297857|SUPERIORITY_OR_OTHER||Group difference (B strain-overall)|4.6|||||TWO_SIDED|95.0|0.4|8.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||8.8|0.4|
91701540|NCT01162122|183297857|SUPERIORITY_OR_OTHER||Group difference(H3N2/Brisbane-high risk|12.4|||||TWO_SIDED|95.0|5.2|19.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||19.6|5.2|
91701541|NCT01162122|183297857|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-highrisk|13.0|||||TWO_SIDED|95.0|5.8|20.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||20.3|5.8|
91701542|NCT01162122|183297857|SUPERIORITY_OR_OTHER||Group difference (B strain-high risk)|5.1|||||TWO_SIDED|95.0|-1.6|11.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||11.8|-1.6|
91493858|NCT05426902|182859384|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.6
91493859|NCT05426902|182859385|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.2
91493860|NCT05426902|182859386|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
91493861|NCT05426902|182859387|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||0.4
91493862|NCT05426902|182859392|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"I feel good about my medical visit at baseline (month 1) vs. intervention period (month 2)."||||0.7
91493863|NCT05426902|182859392|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"My rheumatologist gave me his/her full attention at baseline (month 1) vs. intervention period (month 2)."||||0.8
91493864|NCT05426902|182859392|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"I was able to say everything I wanted to say to my rheumatologist at baseline (month 1) vs. intervention period (month 2)."||||1.0
91701543|NCT05127304|183297866|OTHER|||||||0.639|||||||Weighted clustered linear regression|||Ambulatory visits||||0.639
91701544|NCT05127304|183297866|OTHER|||||||0.535|||||||Weighted clustered linear regression|||Office visits||||0.535
91701545|NCT05127304|183297866|OTHER|||||||0.337|||||||Weighted clustered linear regression|||Outpatient visits||||0.337
91701546|NCT05127304|183297866|OTHER|||||||0.058|||||||Weighted clustered linear regression|||Emergency room visits||||0.058
91701547|NCT05127304|183297866|OTHER|||||||0.192|||||||Weighted clustered linear regression|||Inpatient visits||||0.192
91701548|NCT05127304|183297866|OTHER|||||||0.176|||||||Weighted clustered linear regression|||Other medical visits||||0.176
91701549|NCT05127304|183297867|OTHER|||||||0.313|||||||Weighted clustered linear regression|||||||0.313
91701550|NCT05127304|183297868|OTHER|||||||0.021|||||||Weighted clustered linear regression|||||||0.021
91701551|NCT05127304|183297869|OTHER|||||||0.022|||||||Weighted clustered linear regression|||Ambulatory visits||||0.022
91701552|NCT05127304|183297869|OTHER|||||||0.124|||||||Weighted clustered linear regression|||Office visits||||0.124
91701553|NCT05127304|183297869|OTHER|||||||0.043|||||||Weighted clustered linear regression|||Outpatient visits||||0.043
91701554|NCT05127304|183297869|OTHER|||||||0.99|||||||Weighted clustered linear regression|||Emergency room visits||||0.990
91701555|NCT05127304|183297869|OTHER|||||||0.039|||||||Weighted clustered linear regression|||Inpatient visits||||0.039
91701556|NCT05127304|183297869|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Other medical visits||||<0.001
91701557|NCT05127304|183297870|OTHER|||||||0.163|||||||Weighted clustered linear regression|||||||0.163
91701558|NCT05127304|183297871|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
91701559|NCT05127304|183297872|OTHER|||||||0.017|||||||Weighted clustered linear regression|||Ambulatory visits||||0.017
91701560|NCT05127304|183297872|OTHER|||||||0.098|||||||Weighted clustered linear regression|||Office visits||||0.098
91701561|NCT05127304|183297872|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Outpatient visits||||0.036
91701562|NCT05127304|183297872|OTHER|||||||0.894|||||||Weighted clustered linear regression|||Emergency room visits||||0.894
91701563|NCT05127304|183297872|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Inpatient visits||||0.036
91701564|NCT05127304|183297872|OTHER|||||||0.001|||||||Weighted clustered linear regression|||Other medical visits||||0.001
91701565|NCT05127304|183297873|OTHER|||||||0.162|||||||Weighted clustered linear regression|||||||0.162
91701566|NCT05127304|183297874|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
91701567|NCT05127304|183297875|OTHER|||||||0.065|||||||Weighted clustered linear regression|||Ambulatory visits||||0.065
91701568|NCT05127304|183297875|OTHER|||||||0.102|||||||Weighted clustered linear regression|||Office visits||||0.102
91701569|NCT05127304|183297875|OTHER|||||||0.1|||||||Weighted clustered linear regression|||Outpatient visits||||0.100
91701570|NCT05127304|183297875|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Emergency room visits||||0.189
91701571|NCT05127304|183297875|OTHER|||||||0.024|||||||Weighted clustered linear regression|||Inpatient visits||||0.024
91701572|NCT05127304|183297875|OTHER|||||||0.767|||||||Weighted clustered linear regression|||Other medical visits||||0.767
91701573|NCT05127304|183297876|OTHER|||||||0.357|||||||Weighted clustered linear regression|||||||0.357
91701574|NCT05127304|183297877|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory visits||||0.002
91701575|NCT05127304|183297877|OTHER|||||||0.42|||||||Weighted clustered linear regression|||Office visits||||0.420
91701576|NCT05127304|183297877|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Outpatient visits||||0.002
91701577|NCT05127304|183297877|OTHER|||||||0.304|||||||Weighted clustered linear regression|||Emergency room visits||||0.304
91701578|NCT05127304|183297877|OTHER|||||||0.326|||||||Weighted clustered linear regression|||Inpatient visits||||0.326
91701579|NCT05127304|183297877|OTHER|||||||0.007|||||||Weighted clustered linear regression|||Other medical visits||||0.007
91701580|NCT05127304|183297878|OTHER|||||||0.52|||||||Weighted clustered linear regression|||||||0.520
91493865|NCT05426902|182859394|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"My rheumatologist and I agreed on how active my lupus was today at baseline (month 1) vs. intervention period (month 2)."||||0.7
91493866|NCT05426902|182859394|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"I understand the care recommendations that my doctor or provider gave me today at baseline (month 1) vs. intervention period (month 2)."||||0.8
91493867|NCT05426902|182859395|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline vs. Follow-Up||||0.02
91493868|NCT05426902|182859396|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke meets my approval at baseline (month 1) vs. intervention period (month 2)."||||0.7
91701581|NCT05127304|183297879|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
91701582|NCT05127304|183297880|OTHER|||||||0.06|||||||Weighted clustered linear regression|||Medical costs||||0.060
91701583|NCT05127304|183297880|OTHER|||||||0.177|||||||Weighted clustered linear regression|||Ambulatory costs||||0.177
91701584|NCT05127304|183297880|OTHER|||||||0.834|||||||Weighted clustered linear regression|||Office visits costs||||0.834
91701585|NCT05127304|183297880|OTHER|||||||0.121|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.121
91701586|NCT05127304|183297880|OTHER|||||||0.159|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.159
91701587|NCT05127304|183297880|OTHER|||||||0.289|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.289
91701588|NCT05127304|183297880|OTHER|||||||0.055|||||||Weighted clustered linear regression|||Other medical costs||||0.055
91701589|NCT05127304|183297880|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
91701590|NCT05127304|183297880|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
91701591|NCT05127304|183297881|OTHER|||||||0.066|||||||Weighted clustered linear regression|||Medical costs||||0.066
91701592|NCT05127304|183297881|OTHER|||||||0.193|||||||Weighted clustered linear regression|||Ambulatory costs||||0.193
91701593|NCT05127304|183297881|OTHER|||||||0.117|||||||Weighted clustered linear regression|||Office visits costs||||0.117
91701594|NCT05127304|183297881|OTHER|||||||0.25|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.250
91701595|NCT05127304|183297881|OTHER|||||||0.431|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.431
91701596|NCT05127304|183297881|OTHER|||||||0.129|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.129
91701597|NCT05127304|183297881|OTHER|||||||0.236|||||||Weighted clustered linear regression|||Other medical costs||||0.236
91701598|NCT05127304|183297881|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
91701599|NCT05127304|183297881|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
91701600|NCT05127304|183297882|OTHER|||||||0.057|||||||Weighted clustered linear regression|||Medical costs||||0.057
91701601|NCT05127304|183297882|OTHER|||||||0.182|||||||Weighted clustered linear regression|||Ambulatory costs||||0.182
91701602|NCT05127304|183297882|OTHER|||||||0.083|||||||Weighted clustered linear regression|||Office visits costs||||0.083
91701603|NCT05127304|183297882|OTHER|||||||0.245|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.245
91701604|NCT05127304|183297882|OTHER|||||||0.386|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.386
91701605|NCT05127304|183297882|OTHER|||||||0.115|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.115
91701606|NCT05127304|183297882|OTHER|||||||0.237|||||||Weighted clustered linear regression|||Other medical costs||||0.237
91701607|NCT05127304|183297882|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
91701608|NCT05127304|183297882|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
91731935|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.03||||0.79|TWO_SIDED|97.5|-0.34|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.||0.41|-0.34|0.79
91731936|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.13||||0.26|TWO_SIDED|97.5|-0.38|0.12||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.||0.12|-0.38|0.26
91731937|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.06||||0.71|TWO_SIDED|97.5|-0.31|0.19||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.||0.19|-0.31|0.71
91731938|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.52|TWO_SIDED|97.5|-0.23|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.||0.36|-0.23|0.52
91731939|NCT00721110|183358367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.07||||0.44|TWO_SIDED|97.5|-0.22|0.38|||Chi-squared|||Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.||0.38|-0.22|0.44
91731940|NCT00721110|183358368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.96|TWO_SIDED|97.5|-2.14|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.||2.2|-2.14|0.96
91731941|NCT00721110|183358368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.59|TWO_SIDED|97.5|-1.8|2.57||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.||2.57|-1.80|0.59
91493869|NCT05426902|182859396|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke is appealing to me at baseline (month 1) vs. intervention period (month 2)."||||1.0
91731942|NCT02951481|183358369|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
91731943|NCT02951481|183358370|SUPERIORITY|||||||0.55|TWO_SIDED|95.0|||||Fisher Exact|||||||0.55
91731944|NCT02951481|183358371|SUPERIORITY|||||||0.023|||||||Chi-squared|||||||0.023
91731945|NCT02951481|183358372|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91731946|NCT02951481|183358373|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
91731947|NCT02951481|183358374|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
91731948|NCT02951481|183358375|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
91731949|NCT02951481|183358376|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
91731950|NCT01051661|183358377|SUPERIORITY|The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was \> -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was \>0.|Vaccine efficacy increase|76.7|||||TWO_SIDED|95.0|18.53|93.39||||||Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.||93.39|18.53|
91731951|NCT01051661|183358405|OTHER||Adjusted GMT ratios|5.61|||||TWO_SIDED|95.0|4.92|6.41||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).||6.41|4.92|
91731952|NCT01051661|183358405|OTHER||Adjusted GMT ratios|1.05|||||TWO_SIDED|95.0|0.93|1.19||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).||1.19|0.93|
91731953|NCT01916226|183358445|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|-0.3||0.278|TWO_SIDED|95.0|-0.7|0.2||Estimating the standard deviation of CFB in rTNSS over 2 weeks to be approximately 2.6, a two-sample t-test with α=0.05 suggests that a sample size of 144 participants per arm would provide 90% power to show a difference of 1.0 between treatments.|ANCOVA|||||0.2|-0.7|0.278
91731954|NCT05430919|183358513|SUPERIORITY||Least Squares (LS) Mean Difference|-2.31|||<|0.0001|TWO_SIDED|95.0|-3.229|-1.385|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-1.385|-3.229|<0.0001
91731955|NCT05430919|183358514|SUPERIORITY||LS Mean Difference|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.634|-1.658|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-1.658|-3.634|<0.0001
91731956|NCT05430919|183358514|SUPERIORITY||LS Mean Difference|-1.51||||0.0023|TWO_SIDED|95.0|-2.478|-0.539|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-0.539|-2.478|0.0023
91731957|NCT05430919|183358530|SUPERIORITY||LS Mean Difference|-63.18|||<|0.0001|TWO_SIDED|95.0|-73.411|-52.95|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-52.950|-73.411|<0.0001
91493870|NCT05426902|182859396|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||"I like SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.5
91493871|NCT05426902|182859396|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||"I welcome SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.6
91731958|NCT05430919|183358530|SUPERIORITY||LS Mean Difference|-56.01|||<|0.0001|TWO_SIDED|95.0|-66.806|-45.204|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-45.204|-66.806|<0.0001
91731959|NCT05430919|183358530|SUPERIORITY||LS Mean Difference|-34.82|||<|0.0001|TWO_SIDED|95.0|-45.304|-24.343|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-24.343|-45.304|<0.0001
91731960|NCT01852214|183358621|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
91731961|NCT01852214|183358622|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|||||||0.086
91731962|NCT04105725|183358639|SUPERIORITY||||||<|0.05|||||||negative binomial regression|||||||<0.05
91731963|NCT00553475|183358658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0075||95.0|-1.09|-0.17|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.09|0.0075
91731964|NCT00553475|183358658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0254||95.0|-1.39|-0.09|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.09|-1.39|0.0254
91731965|NCT00553475|183358659|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28||||0.8731||95.0|-3.67|3.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.12|-3.67|0.8731
91731966|NCT00553475|183358659|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.16||||0.6337||95.0|-3.62|5.94|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.94|-3.62|0.6337
91731967|NCT00553475|183358660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1||||0.4398||95.0|-7.44|3.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.24|-7.44|0.4398
91731968|NCT00553475|183358660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.9153||95.0|-7.96|7.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.14|-7.96|0.9153
91731969|NCT00553475|183358661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.4873||95.0|-2.75|5.76|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.76|-2.75|0.4873
91731970|NCT00553475|183358661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.56||||0.4008||95.0|-3.42|8.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.53|-3.42|0.4008
91731971|NCT00553475|183358662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.5372||95.0|-2.13|4.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.09|-2.13|0.5372
91731972|NCT00553475|183358662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.09||||0.348||95.0|-2.29|6.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.47|-2.29|0.3480
91731973|NCT00553475|183358663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.06||||0.0544||95.0|-0.1|10.21|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.21|-0.10|0.0544
91731974|NCT00553475|183358663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.15||||0.0278||95.0|0.89|15.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.42|0.89|0.0278
91731975|NCT00553475|183358664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92||||0.7394||95.0|-4.52|6.37|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.37|-4.52|0.7394
91731976|NCT00553475|183358664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.22||||0.5712||95.0|-5.49|9.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.93|-5.49|0.5712
91731977|NCT00553475|183358665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0058||95.0|-1.14|-0.19|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.0058
91731978|NCT00553475|183358665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0333||95.0|-1.23|-0.05|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.23|0.0333
91731979|NCT00553475|183358666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.153
91731980|NCT00553475|183358666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.059
91731981|NCT00553475|183358667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.0287||95.0|-0.82|-0.05|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-0.82|0.0287
91731982|NCT00553475|183358667|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75||||0.0073||95.0|-1.29|-0.2|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.20|-1.29|0.0073
91731983|NCT00553475|183358668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0021||95.0|-1.0|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.00|0.0021
91731984|NCT00553475|183358668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|||<|0.0001||95.0|-1.78|-0.69|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.69|-1.78|<0.0001
91731985|NCT00553475|183358669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0026||95.0|-0.99|-0.21|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.21|-0.99|0.0026
91731986|NCT00553475|183358669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.13|||<|0.0001||95.0|-1.69|-0.58|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.58|-1.69|<0.0001
91493872|NCT05426902|182859397|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems fitting at baseline (month 1) vs. intervention period (month 2)."||||0.7
91731987|NCT00553475|183358670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0012||95.0|-1.03|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.03|0.0012
91731988|NCT00553475|183358670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||<|0.0001||95.0|-1.67|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.67|<0.0001
91493873|NCT05426902|182859397|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems suitable at baseline (month 1) vs. intervention period (month 2)."||||0.7
91731989|NCT00553475|183358671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0011||95.0|-1.04|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.04|0.0011
91493874|NCT05426902|182859397|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems applicable at baseline (month 1) vs. intervention period (month 2)."||||1.0
91493875|NCT05426902|182859397|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems like a good match at baseline (month 1) vs. intervention period (month 2)."||||1.0
91493876|NCT05426902|182859398|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems implementable at baseline (month 1) vs. intervention period (month 2)."||||0.3
91493877|NCT05426902|182859398|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems possible at baseline (month 1) vs. intervention period (month 2)."||||0.3
91493878|NCT05426902|182859398|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||"SLE@Duke seems doable at baseline (month 1) vs. intervention period (month 2)."||||0.4
91493879|NCT05426902|182859398|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems easy to use at baseline (month 1) vs. intervention period (month 2)."||||0.3
91701609|NCT05127304|183297883|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Medical costs||||0.189
91493880|NCT00429273|182859404|OTHER|Test for differences in treatment outcomes between three different tx|F-Value for variance component|18.9|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Analyses are based on a generalized linear mixed model (GLMM) modelling the effects of the medication when calibrated to optimal dosage and controlling for time effects and within-subject effects. The design is a combined within-between subject design, where each participant is exposed to, and provides information about multiple tx modalities.||||<.01
91493881|NCT01246401|182859412|SUPERIORITY|||||||0.431|||||||Welch's T Test|||||||0.431
91493882|NCT01246401|182859413|SUPERIORITY|||||||0.087|||||||Welch's T Test|||||||0.087
91493883|NCT01246401|182859415|SUPERIORITY|||||||0.03||||||Wilcoxon one sided|Wilcoxon (Mann-Whitney)|||||||0.03
91701610|NCT05127304|183297883|OTHER|||||||0.314|||||||Weighted clustered linear regression|||Ambulatory costs||||0.314
91731990|NCT00553475|183358671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|||<|0.0001||95.0|-1.72|-0.6|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.60|-1.72|<0.0001
91493884|NCT01246401|182859420|SUPERIORITY|||||||0.03962|||||||Chi-squared|||||||0.03962
91493885|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.473|||||TWO_SIDED|95.0|-15.7096|26.6553|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1||26.6553|-15.7096|
91493886|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.598|||||TWO_SIDED|95.0|-21.784|20.5888|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1||20.5888|-21.7840|
91493887|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.906|||||TWO_SIDED|95.0|-9.3489|33.1602|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||33.1602|-9.3489|
91493888|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.671|||||TWO_SIDED|95.0|-16.9957|24.3384|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1||24.3384|-16.9957|
91493889|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.618|||||TWO_SIDED|95.0|-28.2069|37.4425|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||37.4425|-28.2069|
91493890|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.713|||||TWO_SIDED|95.0|-17.0405|39.8527|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein A1||39.8527|-17.0405|
91493891|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.934|||||TWO_SIDED|95.0|-21.0153|31.5504|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein A1||31.5504|-21.0153|
91493892|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.466|||||TWO_SIDED|95.0|-23.7517|24.7608|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein A1||24.7608|-23.7517|
91493893|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.743|||||TWO_SIDED|95.0|-3.246|33.7161|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100||33.7161|-3.2460|
91493894|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.428|||||TWO_SIDED|95.0|-21.3243|8.9224|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.9224|-21.3243|
91701611|NCT05127304|183297883|OTHER|||||||0.203|||||||Weighted clustered linear regression|||Office visits costs||||0.203
91493895|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.96|||||TWO_SIDED|95.0|-26.8137|1.1513|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||1.1513|-26.8137|
91493896|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.903|||||TWO_SIDED|95.0|-16.6557|13.1191|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100||13.1191|-16.6557|
91493897|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.231|||||TWO_SIDED|95.0|-45.1045|-11.3579|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||-11.3579|-45.1045|
91493898|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-23.5021|11.3014|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein B100||11.3014|-23.5021|
91493899|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.49|||||TWO_SIDED|95.0|-25.2721|8.2918|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.2918|-25.2721|
91701612|NCT05127304|183297883|OTHER|||||||0.379|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.379
91701613|NCT05127304|183297883|OTHER|||||||0.815|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.815
91701614|NCT05127304|183297883|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.205
91701615|NCT05127304|183297883|OTHER|||||||0.556|||||||Weighted clustered linear regression|||Other medical costs||||0.556
91701616|NCT05127304|183297883|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||0.189
91731991|NCT00553475|183358672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|||<|0.0001||95.0|-1.18|-0.4|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.40|-1.18|<0.0001
91731992|NCT00553475|183358672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||<|0.0001||95.0|-1.68|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.68|<0.0001
91731993|NCT00553475|183358673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
91731994|NCT00553475|183358673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09||||0.0002||95.0|-1.66|-0.52|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.66|0.0002
91731995|NCT00553475|183358674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0008||95.0|-1.07|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.07|0.0008
91731996|NCT00553475|183358674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94||||0.0014||95.0|-1.51|-0.36|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.36|-1.51|0.0014
91731997|NCT00553475|183358675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
91731998|NCT00553475|183358675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.0036||95.0|-1.44|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.44|0.0036
91731999|NCT00553475|183358676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0005||95.0|-1.1|-0.31|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.31|-1.10|0.0005
91732000|NCT00553475|183358676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.0034||95.0|-1.46|-0.29|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.29|-1.46|0.0034
91732001|NCT00553475|183358677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.0023||95.0|-1.02|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.02|0.0023
91732002|NCT00553475|183358677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0105||95.0|-1.36|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.36|0.0105
91732003|NCT00553475|183358678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0016||95.0|-1.05|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.05|0.0016
91732004|NCT00553475|183358678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0111||95.0|-1.37|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.37|0.0111
91732005|NCT00553475|183358679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07||||0.6118||95.0|-5.23|3.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.08|-5.23|0.6118
91732006|NCT00553475|183358679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.59||||0.0109||95.0|1.76|13.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.42|1.76|0.0109
91732007|NCT00553475|183358680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49||||0.4602||95.0|-2.47|5.45|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.45|-2.47|0.4602
91701617|NCT05127304|183297884|OTHER|||||||0.483|||||||Weighted clustered linear regression|||Medical costs||||0.483
91493900|NCT01218204|182859459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.687|||||TWO_SIDED|95.0|-26.0247|6.6498|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein B100||6.6498|-26.0247|
91701618|NCT05127304|183297884|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory costs||||0.002
91701619|NCT05127304|183297884|OTHER|||||||0.123|||||||Weighted clustered linear regression|||Office visits costs||||0.123
91701620|NCT05127304|183297884|OTHER|||||||0.003|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.003
91701621|NCT05127304|183297884|OTHER|||||||0.17|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.170
91701622|NCT05127304|183297884|OTHER|||||||0.582|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.582
91701623|NCT05127304|183297884|OTHER|||||||0.887|||||||Weighted clustered linear regression|||Other medical costs||||0.887
91701624|NCT05127304|183297884|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
91701625|NCT05127304|183297884|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
91528742|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.9|||<|0.001|TWO_SIDED|95.0|37.8|47.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 16F: V116-PPSV23 Percentage Difference||47.8|37.8|<0.001
91732008|NCT00553475|183358680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.97||||0.1625||95.0|-1.61|9.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.54|-1.61|0.1625
91732009|NCT00553475|183358681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.25|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.25|<0.0001
91732010|NCT00553475|183358681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0273||95.0|-1.19|-0.07|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.07|-1.19|0.0273
91732011|NCT00553475|183358682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.79||||0.0013||95.0|-2.87|-0.71|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.71|-2.87|0.0013
91732012|NCT00553475|183358682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13||||0.0062||95.0|-3.65|-0.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.61|-3.65|0.0062
91732013|NCT00553475|183358683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0068||95.0|-1.03|-0.17|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.03|0.0068
91732014|NCT00553475|183358683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||0.0707||95.0|-1.17|0.05|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.05|-1.17|0.0707
91732015|NCT00553475|183358684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.35||||0.0013||95.0|-3.76|-0.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.93|-3.76|0.0013
91732016|NCT00553475|183358684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.67||||0.0087||95.0|-4.67|-0.68|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.68|-4.67|0.0087
91732017|NCT00553475|183358685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.27||||0.0056||95.0|-12.4|-2.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.14|-12.40|0.0056
91732018|NCT00553475|183358685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.49||||0.0427||95.0|-14.74|-0.25|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-14.74|0.0427
91732019|NCT00553475|183358686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.0365||95.0|-0.4|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-0.40|0.0365
91732020|NCT00553475|183358686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.0073||95.0|-0.65|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-0.65|0.0073
91493901|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.471|||||TWO_SIDED|95.0|-47.9323|3.202|||||Statistical analysis was performed using LS mean value Atorvastatin|||3.2020|-47.9323|
91732021|NCT00553475|183358687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.37||||0.0019||95.0|-10.38|-2.36|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.36|-10.38|0.0019
91732022|NCT00553475|183358687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.78||||0.1907||95.0|-9.45|1.89|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.89|-9.45|0.1907
91493902|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.91|||||TWO_SIDED|95.0|-38.1027|25.3126|||||Statistical analysis was performed using LS mean value Atorvastatin|||25.3126|-38.1027|
91732023|NCT00553475|183358688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9905||95.0|-5.37|5.43|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.43|-5.37|0.9905
91732024|NCT00553475|183358688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.44||||0.2532||95.0|-3.19|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-3.19|0.2532
91493903|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.985|||||TWO_SIDED|95.0|-45.5492|1.8605|||||Statistical analysis was performed using LS mean value Atorvastatin|||1.8605|-45.5492|
91493904|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.697|||||TWO_SIDED|95.0|-45.0846|13.3024|||||Statistical analysis was performed using LS mean value Atorvastatin|||13.3024|-45.0846|
91493905|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.036|||||TWO_SIDED|95.0|-27.2281|15.1569|||||Statistical analysis was performed using LS mean value of Atorvastatin|||15.1569|-27.2281|
91493906|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.198|||||TWO_SIDED|95.0|-24.2901|32.6057|||||Statistical analysis was performed using LS mean value of GSK1292263|||32.6057|-24.2901|
91493907|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.117|||||TWO_SIDED|95.0|-40.4767|1.906|||||Statistical analysis was performed using LS mean value of GSK1292263|||1.9060|-40.4767|
91528743|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|29.6|41.8||1-sided|Stratified Miettinen & Nurminen method||V16 minus PPSV23|Serotype 23A: V116-PPSV23 Percentage Difference||41.8|29.6|<0.001
91528744|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|37.6|47.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 23B: V116-PPSV23 Percentage Difference||47.0|37.6|<0.001
91493908|NCT01218204|182859460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.798|||||TWO_SIDED|95.0|-48.3842|-12.5064|||||Statistical analysis was performed using LS mean value of GSK1292263|||-12.5064|-48.3842|
91528745|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|30.6|41.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 24F: V116-PPSV23 Percentage Difference||41.0|30.6|<0.001
91493909|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.101|||||TWO_SIDED|95.0|-4.5469|14.7495|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||14.7495|-4.5469|
91528746|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|56.2|||<|0.001|TWO_SIDED|95.0|51.5|60.5||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 31: V116-PPSV23 Percentage Difference||60.5|51.5|<0.001
91701626|NCT05127304|183297885|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Any COPD exacerbation||||0.205
91493910|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.273|||||TWO_SIDED|95.0|2.5937|21.9532|||||Statistical analysis was performed using LS mean value of Atorvastatin|Fo HDLc||21.9532|2.5937|
91493911|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.833|||||TWO_SIDED|95.0|18.955|38.7102|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||38.7102|18.9550|
91493912|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.701|||||TWO_SIDED|95.0|-5.5562|12.9578|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||12.9578|-5.5562|
91493913|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.946|||||TWO_SIDED|95.0|8.612|33.281|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||33.2810|8.6120|
91493914|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.561|||||TWO_SIDED|95.0|-0.9675|22.0898|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.0898|-0.9675|
91493915|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.122|||||TWO_SIDED|95.0|-0.2902|22.5351|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.5351|-0.2902|
91493916|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.689|||||TWO_SIDED|95.0|9.7527|31.6262|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||31.6262|9.7527|
91701627|NCT05127304|183297885|OTHER|||||||0.454|||||||Weighted clustered linear regression|||Severe COPD exacerbation||||0.454
91701628|NCT05127304|183297886|OTHER|||||||0.06|||||||Rao-Scott test|||||||0.060
91701629|NCT00955968|183297909|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.54|TWO_SIDED|95.0|0.19|2.4||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.40|0.19|0.54
91701630|NCT00955968|183297910|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.66|TWO_SIDED|95.0|0.11|4.01||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||4.01|0.11|0.66
91701631|NCT00955968|183297912|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.44|TWO_SIDED|95.0|0.09|2.81||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.81|0.09|0.44
91701632|NCT00955968|183297913|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.79|TWO_SIDED|95.0|0.54|1.6||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.60|0.54|0.79
91701633|NCT00955968|183297914|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.52|0.54|0.71
91701634|NCT00955968|183297915|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.42|0.8||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||0.80|0.42|<0.001
91701635|NCT00955968|183297916|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1|TWO_SIDED|95.0|0.72|1.03||5% alpha level and 2-sided test|Log Rank|||||1.03|0.72|0.10
91705514|NCT01080391|183305557|SUPERIORITY||Odds Ratio (OR)|3.472|||<|0.0001|TWO_SIDED|95.0|2.411|5.001|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||5.001|2.411|< 0.0001
91705515|NCT01080391|183305558|SUPERIORITY||Odds Ratio (OR)|1.897||||0.0044|TWO_SIDED|95.0|1.17|3.08|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||3.08|1.17|0.0044
91705516|NCT02638051|183305594|SUPERIORITY_OR_OTHER|||||||0.014|||||||Chi-squared|||"Applies to Objective Response Rate (ORR)"||||0.0140
91493917|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.549|||||TWO_SIDED|95.0|-18.775|9.6768|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||9.6768|-18.7750|
91493918|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.337|||||TWO_SIDED|95.0|-24.4549|3.7803|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||3.7803|-24.4549|
91493919|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.317|||||TWO_SIDED|95.0|-36.0144|-6.619|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.6190|-36.0144|
91493920|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.173|||||TWO_SIDED|95.0|-34.271|-6.0755|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.0755|-34.2710|
91493921|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.472|||||TWO_SIDED|95.0|-49.3385|-8.1558|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-8.1558|-49.3385|
91528747|NCT05569954|182933493|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|58.7|||<|0.001||95.0|54.6|62.7||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 35B: V116-PPSV23 Percentage Difference||62.7|54.6|<0.001
91701636|NCT00474045|183297956|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.074||0.4||95.0|-0.21|0.08||P-value for superiority was calculated.|Regression, Linear|Treatment, country, pregnancy (preg.) status at randomisation (random.)-fixed. HbA1c at rand.(covariate) \& at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% confidence interval (CI) was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.08|-0.21|0.400
91705517|NCT02638051|183305595|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Chi-squared|||"Applies to All Adverse Events rate"||||0.0016
91705518|NCT02638051|183305595|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Abdominal pain rate"||||>0.05
91528748|NCT05569954|182933494|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."||||||0.093||||||1-sided|Clopper-Pearson method|||Serotype 6C||||0.093
91528749|NCT05569954|182933494|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method|||Serotype 15B||||<0.001
91528750|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|1.04|1.25|||||V116/PPSV23|Serotype 3: V116/PPSV23 GMC Ratio||1.25|1.04|
91493922|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.128|||||TWO_SIDED|95.0|-23.3049|-0.9514|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-0.9514|-23.3049|
91493923|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.798|||||TWO_SIDED|95.0|-27.1364|-4.4589|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-4.4589|-27.1364|
91493924|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.789|||||TWO_SIDED|95.0|-32.3413|-11.2372|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-11.2372|-32.3413|
91493925|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.498|||||TWO_SIDED|95.0|-38.446|-2.4169|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-2.4169|-38.4460|
91493926|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.781|||||TWO_SIDED|95.0|-39.1603|-4.513|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-4.5130|-39.1603|
91493927|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.923|||||TWO_SIDED|95.0|-52.3394|-24.2717|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-24.2717|-52.3394|
91493928|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.444|||||TWO_SIDED|95.0|-33.502|2.491|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||2.4910|-33.5020|
91493929|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.781|||||TWO_SIDED|95.0|-40.296|-3.2667|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-3.2667|-40.2960|
91493930|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.421|||||TWO_SIDED|95.0|-38.3519|-4.4911|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-4.4911|-38.3519|
91493931|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.361|||||TWO_SIDED|95.0|-63.465|-29.2561|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-29.2561|-63.4650|
91493932|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.843|||||TWO_SIDED|95.0|-70.7854|-38.9007|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-38.9007|-70.7854|
91493933|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.756|||||TWO_SIDED|95.0|-21.7561|2.2448|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||2.2448|-21.7561|
91528751|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 7F: V116/PPSV23 GMC Ratio||2.10|1.65|
91528752|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|1.04|1.31|||||V116/PPSV23|Serotype 8: V116/PPSV23 GMC Ratio||1.31|1.04|
91705519|NCT02638051|183305595|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Gastrointestinal reactions"||||>0.05
91705520|NCT02638051|183305595|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Damage of hepatic or renal function"||||>0.05
91705521|NCT02638051|183305595|SUPERIORITY_OR_OTHER|||||||0.0215|||||||Chi-squared|||"Applies to Bone marrow depression"||||0.0215
91493934|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.014|||||TWO_SIDED|95.0|-25.7497|-2.2787|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-2.2787|-25.7497|
91701637|NCT00474045|183297957|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.096||0.122||95.0|-0.34|0.04||P-value for superiority was calculated|Regression, Linear|Treatment, country, preg. status at rand.(fixed factors),HbA1c at rand.(covariate),HbA1c at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% CI was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.04|-0.34|0.122
91493935|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.675|||||TWO_SIDED|95.0|-39.8454|-15.5045|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-15.5045|-39.8454|
91493936|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.937|||||TWO_SIDED|95.0|-32.6057|-9.269|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-9.2690|-32.6057|
91493937|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.702|||||TWO_SIDED|95.0|-29.0346|-14.3696|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-14.3696|-29.0346|
91493938|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|||||TWO_SIDED|95.0|-23.0636|-3.2961|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-3.2961|-23.0636|
91701638|NCT02135107|183298003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||||||<0.001
91701639|NCT02135107|183298004|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at a two-sided significance level of alpha = 0.05.||Comparison at Week 12||||<0.001
91701640|NCT02135107|183298004|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||Comparison at Week 24||||<0.001
91701641|NCT02135107|183298005|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.49|||Log Rank|||||0.49|0.23|<0.001
91701642|NCT02135107|183298006|SUPERIORITY||Group difference|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||-6.8|-23.5|<0.001
91701643|NCT02135107|183298009|SUPERIORITY||Group difference|0.0|||=|0.992|TWO_SIDED|95.0|-3.5|3.5||P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Chi-squared||Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||3.5|-3.5|=0.992
91701644|NCT02278120|183298014|SUPERIORITY||Hazard Ratio, log|0.553|||<|1e-07|TWO_SIDED|95.0|0.441|0.694|||Log Rank|||||0.694|0.441|<0.0000001
91701645|NCT02278120|183298015|SUPERIORITY||Cox Proportional Hazard|0.712||||0.00973|TWO_SIDED|95.0|0.535|0.948||One-sided stratified log-rank test|Log Rank|||||0.948|0.535|0.00973
91701646|NCT02278120|183298016|SUPERIORITY|||||||0.00098|||||||Cochran-Mantel-Haenszel|||||||0.000980
91701647|NCT02278120|183298017|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.002
91701648|NCT00808639|183298027|SUPERIORITY_OR_OTHER||Pathologic response rate|49.0|||||TWO_SIDED|80.0|38.0|61.0||||||This study used a Simon's optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.||61|38|
91701649|NCT02266472|183298030|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|99.11|STANDARD_DEVIATION|6.3|<|0.0001|TWO_SIDED|90.0|96.4|101.89|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.89|96.40|<0.0001
91701650|NCT02266472|183298031|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints,using an acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|101.25|STANDARD_DEVIATION|10.7|<|0.0001|TWO_SIDED|90.0|96.54|106.19|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.19|96.54|<0.0001
91705522|NCT02638051|183305596|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Chi-squared|||"Applies to Better QoL"||||0.0053
91705523|NCT02638051|183305596|SUPERIORITY_OR_OTHER|||||||0.0527|||||||Chi-squared|||"Applies to No Change"||||0.0527
91705524|NCT02638051|183305596|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Worse QoL"||||>0.05
91705525|NCT03611582|183305611|SUPERIORITY||Treatment difference|-10.27|||<|0.0001|TWO_SIDED|95.0|-11.97|-8.57|||ANCOVA|||Treatment policy estimand||-8.57|-11.97|<.0001
91705526|NCT03611582|183305611|SUPERIORITY||Treatment difference|-12.67|||<|0.0001|TWO_SIDED|95.0|-14.34|-11.0|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-11.00|-14.34|<0.0001
91705527|NCT03611582|183305612|SUPERIORITY||Odds Ratio (OR)|6.11|||<|0.0001|TWO_SIDED|95.0|4.04|9.26|||Regression, Logistic|||Treatment policy estimand||9.26|4.04|<0.0001
91705528|NCT03611582|183305612|SUPERIORITY||Odds Ratio (OR)|11.67|||<|0.0001|TWO_SIDED|95.0|7.64|17.81|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||17.81|7.64|<0.0001
91528753|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.76|||||V116/PPSV23|Serotype 9N: V116/PPSV23 GMC Ratio||1.76|1.37|
91528754|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.03|||||TWO_SIDED|95.0|1.79|2.31|||||V116/PPSV23|Serotype 10A: V116/PPSV23 GMC Ratio||2.31|1.79|
91528755|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.2|||||TWO_SIDED|95.0|1.97|2.46|||||V116/PPSV23|Serotype 11A: V116/PPSV23 GMC Ratio||2.46|1.97|
91528756|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.72|2.3|||||V116/PPSV23|Serotype 12F: V116/PPSV23 GMC Ratio||2.30|1.72|
91528757|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.39|||||TWO_SIDED|95.0|2.12|2.7|||||V116/PPSV23|Serotype 17F: V116/PPSV23 GMC Ratio||2.70|2.12|
91732025|NCT00553475|183358689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.4538||95.0|-5.05|2.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.26|-5.05|0.4538
91732026|NCT00553475|183358689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84||||0.2782||95.0|-7.97|2.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.30|-7.97|0.2782
91732027|NCT00553475|183358690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32||||0.0177||95.0|0.06|0.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.59|0.06|0.0177
91732028|NCT00553475|183358690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.3661||95.0|-0.2|0.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.55|-0.20|0.3661
91732029|NCT00553475|183358691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62||||0.0511||95.0|-0.03|11.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.26|-0.03|0.0511
91732030|NCT00553475|183358691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.65||||0.0173||95.0|1.72|17.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.59|1.72|0.0173
91732031|NCT00553475|183358692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.79||||0.1123||95.0|-0.89|8.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.47|-0.89|0.1123
91732032|NCT00553475|183358692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.79||||0.0206||95.0|1.2|14.38|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||14.38|1.20|0.0206
91732033|NCT00553475|183358693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54||||0.0269||95.0|-6.67|-0.41|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.41|-6.67|0.0269
91732034|NCT00553475|183358693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.4183||95.0|-6.24|2.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.60|-6.24|0.4183
91528758|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.49|||||TWO_SIDED|95.0|1.32|1.67||||||Serotype 19A: V116/PPSV23 GMC Ratio|V116/PPSV23|1.67|1.32|
91528759|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 20A: V116/PPSV23 GMC Ratio||2.10|1.65|
91732035|NCT00553475|183358694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0148
91732036|NCT00553475|183358694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0063
91493939|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.151|||||TWO_SIDED|95.0|-31.942|-12.3605|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-12.3605|-31.9420|
91493940|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.948|||||TWO_SIDED|95.0|-36.2874|-17.6092|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-17.6092|-36.2874|
91493941|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.904|||||TWO_SIDED|95.0|-11.8484|4.04|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||4.0400|-11.8484|
91493942|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.437|||||TWO_SIDED|95.0|-14.346|1.4722|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||1.4722|-14.3460|
91493943|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.294|||||TWO_SIDED|95.0|-18.3923|-2.196|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-2.1960|-18.3923|
91732037|NCT00553475|183358695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0818
91732038|NCT00553475|183358695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0075
91732039|NCT00553475|183358696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.0013||95.0|-1.07|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.07|0.0013
91732040|NCT00553475|183358696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0152||95.0|-1.34|-0.14|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.34|0.0152
91732041|NCT00773461|183358697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91732042|NCT00773461|183358697|SUPERIORITY_OR_OTHER||||||<|0.0001||||||ITT Population (Sensitivity)|Cochran-Mantel-Haenszel|||||||<0.0001
91732043|NCT00773461|183358698|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Comparison of ACR 50 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||<0.0001
91732044|NCT00773461|183358698|SUPERIORITY_OR_OTHER|||||||0.0345||||||Comparison of ACR 70 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||0.0345
91732045|NCT00773461|183358700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||<|0.0001|TWO_SIDED|95.0|-6.6|-2.8||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Swollen Joint Count||-2.8|-6.6|<0.0001
91732046|NCT00773461|183358700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.3|-6.1||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count||-6.1|-11.3|<0.0001
91493944|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.065|||||TWO_SIDED|95.0|-19.7688|-4.3609|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-4.3609|-19.7688|
91493945|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.941|||||TWO_SIDED|95.0|-13.9778|-1.9039|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-1.9039|-13.9778|
91493946|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.384|||||TWO_SIDED|95.0|-15.9023|-0.866|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-0.8660|-15.9023|
91493947|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||||TWO_SIDED|95.0|-23.1404|-8.2592|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-8.2592|-23.1404|
91493948|NCT01218204|182859461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.728|||||TWO_SIDED|95.0|-23.8395|-9.6161||||||For Cholesterol||-9.6161|-23.8395|
91493949|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.123|||||TWO_SIDED|95.0|-26.6276|2.3814|||||Statistical analysis was performed using LS mean value of Atorvastatin|||2.3814|-26.6276|
91493950|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.63|||||TWO_SIDED|95.0|-35.9419|-7.3181|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-7.3181|-35.9419|
91493951|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-41.506|||||TWO_SIDED|95.0|-56.3924|-26.6205|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-26.6205|-56.3924|
91493952|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.041|||||TWO_SIDED|95.0|-42.2554|-13.8263|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-13.8263|-42.2554|
91493953|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.293|||||TWO_SIDED|95.0|-51.5654|-12.4042|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-12.4042|-51.5654|
91732047|NCT00773461|183358701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.3|-12.9|||ANCOVA|||||-12.9|-25.3|<0.0001
91493954|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.042|||||TWO_SIDED|95.0|-34.8358|-5.2472|||||Statistical analysis was performed using LS mean value of GSK1292263|||-5.2472|-34.8358|
91493955|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.903|||||TWO_SIDED|95.0|-36.6155|-7.1913|||||Statistical analysis was performed using LS mean value of GSK1292263|||-7.1913|-36.6155|
91493956|NCT01218204|182859462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.735|||||TWO_SIDED|95.0|-49.722|-21.7485|||||Statistical analysis was performed using LS mean value of GSK1292263|||-21.7485|-49.7220|
91732048|NCT00773461|183358702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.0001|TWO_SIDED|95.0|-24.5|-14.0|||ANCOVA|||||-14.0|-24.5|<0.0001
91493957|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.409|||||TWO_SIDED|95.0|-1.0123|0.1942|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1942|-1.0123|
91493958|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296|||||TWO_SIDED|95.0|-0.9063|0.3141|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.3141|-0.9063|
91493959|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.811|||||TWO_SIDED|95.0|-1.4125|-0.2098|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.2098|-1.4125|
91732049|NCT00773461|183358703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|||<|0.0001|TWO_SIDED|95.0|-25.2|-12.7|||ANCOVA|||||-12.7|-25.2|<0.0001
91732050|NCT00773461|183358704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7384|||<|0.0001|TWO_SIDED|95.0|-2.1464|-1.3303|||ANCOVA|||||-1.3303|-2.1464|<0.0001
91732051|NCT00773461|183358705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.2|||<|0.0001|TWO_SIDED|95.0|-44.7|-33.7|||ANCOVA|||||-33.7|-44.7|<.0001
91732052|NCT00773461|183358707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0003|TWO_SIDED|95.0|1.8|5.9|||ANCOVA|||||5.9|1.8|0.0003
91732053|NCT00773461|183358708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.3||||0.0599|TWO_SIDED|95.0|-139.5|2.9|||ANCOVA|||||2.9|-139.5|0.0599
91732054|NCT00773461|183358709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.956|||<|0.0001|TWO_SIDED|95.0|9.125|16.786|||ANCOVA|||||16.786|9.125|<0.0001
91732055|NCT00773461|183358710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||ANCOVA|||||-0.28|-0.56|<0.0001
91732056|NCT00913835|183358714|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.054||||0.8049|TWO_SIDED|90.0|0.751|1.478|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.478|0.751|0.8049
91732057|NCT00913835|183358715|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.115||||0.6346|TWO_SIDED|90.0|0.768|1.618|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.618|0.768|0.6346
91732058|NCT00913835|183358716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.6190
91732059|NCT00107575|183358739|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>.05
91732060|NCT00107575|183358740|SUPERIORITY_OR_OTHER||expected count ratio|0.81||||0.027|TWO_SIDED|95.0|0.67|0.98||a priori p-value was p \< .05|generalized estimating equations|Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking||||0.98|0.67|.027
91732061|NCT00107575|183358741|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||.18
91732062|NCT00107575|183358742|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||||||.95
91732063|NCT00107575|183358743|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared|||||||.76
91493960|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.422|||||TWO_SIDED|95.0|-0.9831|0.1394|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1394|-0.9831|
91493961|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.384|||||TWO_SIDED|95.0|-0.6009|-0.1669|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.1669|-0.6009|
91493962|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.648|||||TWO_SIDED|95.0|-1.1657|-0.1302|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.1302|-1.1657|
91493963|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.782|||||TWO_SIDED|95.0|-1.2804|-0.2844|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.2844|-1.2804|
91493964|NCT01218204|182859463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.884|||||TWO_SIDED|95.0|-1.3652|-0.4026|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.4026|-1.3652|
91732064|NCT02947984|183358760|OTHER|||||||0.234|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the overall cohort.||||0.234
91732065|NCT02947984|183358760|OTHER|||||||0.82|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the subgroup receiving treatment due to a sub-total resection||||.820
91732066|NCT02947984|183358760|OTHER|||||||0.061|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the sub-group receiving treatment due to recurrent disease||||.061
91732067|NCT04378153|183358776|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
91732068|NCT03345550|183358777|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||Baseline||||.24
91732069|NCT03345550|183358777|SUPERIORITY|||||||0.43|||||||Kruskal-Wallis|||1 month analysis||||.43
91732070|NCT03345550|183358777|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||3 month||||.54
91732071|NCT03345550|183358780|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||.31
91732072|NCT01149460|183358792|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|111.34|||||TWO_SIDED|90.0|100.54|123.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||123.29|100.54|
91732073|NCT01149460|183358793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.34|103.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.82|96.34|
91732074|NCT01149460|183358794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.38|103.78|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.78|96.38|
91732075|NCT01149460|183358795|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|103.48|||||TWO_SIDED|90.0|97.87|109.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||109.41|97.87|
91732076|NCT01149460|183358796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|99.2|||||TWO_SIDED|90.0|97.14|101.31|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.31|97.14|
91732077|NCT01149460|183358797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means|99.1|||||TWO_SIDED|90.0|97.04|101.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.19|97.04|
91732078|NCT00734032|183358813|SUPERIORITY||Ratio|0.514|||<|0.001|TWO_SIDED|95.0|0.449|0.59|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 40 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.590|0.449|<.001
91732079|NCT00734032|183358813|SUPERIORITY||Ratio|0.421|||<|0.001|TWO_SIDED|95.0|0.367|0.483|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 80 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.483|0.367|<.001
91732080|NCT00734032|183358813|SUPERIORITY||Ratio|0.326|||<|0.001|TWO_SIDED|95.0|0.284|0.375|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 160 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.375|0.284|<.001
91732081|NCT00137449|183358819|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.0||||||95.0|31.3|68.7|||F distribution|||||68.7|31.3|
91493965|NCT00407797|182859479|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
91493966|NCT00407797|182859480|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.0001
91732082|NCT00137449|183358819|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|56.7||||||95.0|37.4|74.5|||F distribution|||||74.5|37.4|
91732083|NCT00137449|183358819|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|53.3||||||95.0|40.0|66.3|||F distribution|||Null hypothesis that the true CBR \<=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% \& 90% power. If \>=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If \<= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.||66.3|40.0|
91732084|NCT00137449|183358821|SUPERIORITY_OR_OTHER||ORR rate (percentage)|10.0||||||95.0|2.1|26.5|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||26.5|2.1|
91732085|NCT00137449|183358821|SUPERIORITY_OR_OTHER||ORR rate (percentage)|16.7||||||95.0|5.6|34.7|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||34.7|5.6|
91732086|NCT00137449|183358821|SUPERIORITY_OR_OTHER||ORR rate (percentage)|13.3||||||95.0|5.9|24.6|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||24.6|5.9|
91732087|NCT00137449|183358823|SUPERIORITY_OR_OTHER||median|27.0||||||95.0|22.0|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.||73.1|22.0|
91732088|NCT00137449|183358823|SUPERIORITY_OR_OTHER||median|35.1||||||95.0|24.4|51.6|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||51.6|24.4|
91732089|NCT00137449|183358823|SUPERIORITY_OR_OTHER||median|33.6||||||95.0|24.1|49.0|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||49.0|24.1|
91732090|NCT00137449|183358824|SUPERIORITY_OR_OTHER||median|57.0||||||95.0|24.1|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||73.1|24.1|
91732091|NCT00137449|183358824|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
91732092|NCT00137449|183358824|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
91732093|NCT00137449|183358826|SUPERIORITY_OR_OTHER||1 year survival rate|60.0||||||95.0|40.5|75.0|||Kaplan-Meier method|||||75.0|40.5|
91493967|NCT00407797|182859481|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
91493968|NCT00407797|182859482|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \<= 6 seizures during Baseline period.||||<.0001
91493969|NCT00407797|182859482|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \> 6 seizures during Baseline Period.||||<.0001
91732094|NCT00137449|183358826|SUPERIORITY_OR_OTHER||1 year survival rate|79.7||||||95.0|60.3|90.3|||Kaplan-Meier method|||||90.3|60.3|
91732095|NCT00137449|183358826|SUPERIORITY_OR_OTHER||1 year survival rate|69.7||||||95.0|56.3|79.7|||Kaplan-Meier method|||||79.7|56.3|
91493970|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0552
91732096|NCT02296099|183358830|EQUIVALENCE|The Mann-Whitney U test was utilized.||||||0.014||||||The p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|There were no adjustments.||The null hypothesis is that there is no difference in the pain scores between the two groups.||||0.014
91732097|NCT01356940|183358840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.586||||0.586|TWO_SIDED||||||Mixed Models Analysis||P values above 0.05 are considered statistically not significant in this study|||||0.586
91732098|NCT02272985|183358846|OTHER||||||=|0.03||||||the p value was calculated|Mixed Models Analysis|||||||=0.03
91732099|NCT02272985|183358847|OTHER|||||||0.001|||||||Mixed Models Analysis|||Left frontal gray matter:||||0.001
91732100|NCT02272985|183358847|OTHER|||||||0.08|||||||Mixed Models Analysis|||Right frontal gray matter:||||0.08
91732101|NCT02489279|183358850|SUPERIORITY|||||||0.026|||||||GLM with repeated measures ANOVA|||We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.026
91732102|NCT02489279|183358850|SUPERIORITY|||||||0.0075|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0075
91732103|NCT02489279|183358850|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.25
91732104|NCT02489279|183358851|SUPERIORITY|||||||0.014|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.014
91732105|NCT02489279|183358851|SUPERIORITY|||||||0.0005|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0005
91732106|NCT02489279|183358851|SUPERIORITY|||||||0.21|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.21
91732107|NCT02489279|183358852|SUPERIORITY|||||||1e-06|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.000001
91493971|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0350
91493972|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||t-test, 2 sided|||Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.6743
91732108|NCT02489279|183358853|SUPERIORITY|||||||0.00018|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.00018
91732109|NCT03707821|183358868|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|3.3|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|-2.0|8.5|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||8.5|-2.0|
91732110|NCT03707821|183358869|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 2 was used. This margin is based on a 10% difference if the proportion of subjects that report a higher rating/experience.|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.034|||TWO_SIDED|95.0|0.02|0.15|||Bayesian random -effects model|A 95% Credible Interval for the Posterior proportion mean difference between the Test and Control was used to test for non-inferiority.|mean difference was calculated as Test minus Control.|It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).||0.15|0.02|
91732111|NCT03707821|183358870|NON_INFERIORITY|A non-inferiority margin of 0.05 points was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-0.04|-0.01|||Bayesian Normal Random effects model|A 95% Credible Interval for the Posterior mean difference between the Test and control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||-0.01|-0.04|
91493973|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4736|TWO_SIDED||||||t-test, 2 sided|||LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.4736
91493974|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8173|TWO_SIDED||||||t-test, 2 sided|||Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8173
91493975|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9092|TWO_SIDED||||||t-test, 2 sided|||LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.9092
91493976|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1091|TWO_SIDED||||||t-test, 2 sided|||Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1091
91493977|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||t-test, 2 sided|||LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0944
91528760|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.77|||||TWO_SIDED|95.0|1.55|2.02|||||V116/PPSV23|Serotype 22F: V116/PPSV23 GMC Ratio||2.02|1.55|
91493978|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928|TWO_SIDED||||||t-test, 2 sided|||Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8928
91493979|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7669|TWO_SIDED||||||t-test, 2 sided|||LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.7669
91493980|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1698|TWO_SIDED||||||t-test, 2 sided|||Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1698
91528761|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.08|1.37|||||V116/PPSV23|Serotype 33F: V116/PPSV23 GMC Ratio||1.37|1.08|
91732112|NCT03707821|183358871|SUPERIORITY|A superiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|Mean Percentage of Acceptable Fitting|99.5|STANDARD_DEVIATION|0.38|||TWO_SIDED|95.0|98.5|100.0|||Bayesian Beta-Binomial Model|model for correlated data||It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100|98.5|
91732113|NCT03707821|183358872|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0036|||TWO_SIDED|95.0|-0.007|0.008|||Bayesian beta-binomial model|model for correlated data|mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.008|-0.007|
91493981|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0898|TWO_SIDED||||||t-test, 2 sided|||LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0898
91493982|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0465|TWO_SIDED||||||t-test, 2 sided|||Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0465
91493983|NCT00407797|182859488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0316|TWO_SIDED||||||t-test, 2 sided|||LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0316
91493984|NCT00407797|182859489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2187|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.2187
91493985|NCT00407797|182859489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1905|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1905
91493986|NCT00407797|182859490|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
91493987|NCT00407797|182859490|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
91493988|NCT00407797|182859490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0799|TWO_SIDED||||||t-test, 2 sided|||Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0799
91493989|NCT00407797|182859490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846|TWO_SIDED||||||t-test, 2 sided|||Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0846
91493990|NCT03250845|182859507|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%||||<0.0001
91493991|NCT03250845|182859508|SUPERIORITY||||||<|0.0005|||||||t-test, 1 sided|||H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%||||<0.0005
91493992|NCT03250845|182859510|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion||||0.03
91493993|NCT05973981|182859560|OTHER||Slope|0.19|||||TWO_SIDED|95.0|-0.25|0.63|||||Adjusted for age, sex, and race|||0.63|-0.25|
91493994|NCT05973981|182859560|OTHER||Slope|0.03|||||TWO_SIDED|95.0|-0.41|0.46|||||adjusted for age, sex, and race|||0.46|-0.41|
91493995|NCT02002091|182859561|OTHER|||||||0.706|||||||Chi-squared|||||||0.706
91528762|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.78|||||TWO_SIDED|95.0|3.29|4.35|||||V116/PPSV23|Serotype 6A: V116/PPSV23 GMC Ratio||4.35|3.29|
91528763|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|7.89|10.09|||||V116/PPSV23|Serotype 15A: V116/PPSV23 GMC Ratio||10.09|7.89|
91528764|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|3.01|3.92|||||V116/PPSV23|Serotype 15C: V116/PPSV23 GMC Ratio||3.92|3.01|
91732114|NCT03707821|183358873|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|2.5|STANDARD_DEVIATION|1.94|||TWO_SIDED|95.0|-1.3|6.3|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||6.3|-1.3|
91493996|NCT02002091|182859562|OTHER|||||||0.346|||||||Chi-squared|||||||0.346
91493997|NCT02002091|182859563|OTHER|||||||0.123|||||||Mantel Haenszel|||||||0.123
91493998|NCT02002091|182859564|OTHER|||||||0.968|||||||Chi-squared, Corrected|||||||0.968
91493999|NCT02002091|182859565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The threshold for statistical significance for P-Value is \<0.05|Fisher Exact|||||||0.004
91494000|NCT02002091|182859566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|||||||Fisher Exact|||||||0.988
91528765|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|9.84|||||TWO_SIDED|95.0|8.83|10.97|||||V116/PPSV23|Serotype 16F: V116/PPSV23 GMC Ratio||10.97|8.83|
91732115|NCT03707821|183358874|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|8.03|STANDARD_DEVIATION|2.295|||TWO_SIDED|95.0|3.48|12.54|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||12.54|3.48|
91732116|NCT01432444|183358875|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was derived from Exact McNemar test.|McNemar|||Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.||||<.0001
91732117|NCT01432444|183358876|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, 12 and 24.||||<.0001
91732118|NCT01432444|183358877|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, Week 12 and Week 24.||||<.0001
91732119|NCT01432444|183358878|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analysis for Week 4, 12 and 24.||||<.0001
91732120|NCT01432444|183358879|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from t-test of mean=0.|t-test|||Statistical analysEs for Week 4, 12 and 24.||||<.0001
91732121|NCT02378480|183358890|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||4.9|-6.3|
91732122|NCT02378480|183358891|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-3.2|8.2|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.2|-3.2|
91732123|NCT02378480|183358892|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.8|||||TWO_SIDED|95.0|-1.0|6.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||6.9|-1.0|
91732124|NCT03802916|183358906|SUPERIORITY|||||||0.0074||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0074
91732125|NCT03802916|183358906|SUPERIORITY|||||||0.0002||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0002
91528766|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|7.59|||||TWO_SIDED|95.0|6.68|8.61|||||V116/PPSV23|Serotype 23A: V116/PPSV23 GMC Ratio||8.61|6.68|
91528767|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|4.79|||||TWO_SIDED|95.0|4.26|5.38|||||V116/PPSV23|Serotype 23B: V116/PPSV23 GMC Ratio||5.38|4.26|
91732126|NCT02743221|183358928|OTHER|This was a non-comparative study.|Hazard Ratio (HR)|0.71||||0.09|TWO_SIDED|95.0|0.48|1.06|||Cox proportional hazard model|Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)||||1.06|0.48|0.09
91732127|NCT02743221|183358929|OTHER|||||||0.73|||||||Fisher Exact|||||||0.73
91732128|NCT02743221|183358930|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.49|2.74||||||||2.74|0.49|
91732129|NCT02743221|183358931|OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
91732130|NCT02743221|183358932|OTHER||Hazard Ratio (HR)|0.56||||0.04|TWO_SIDED|95.0|0.32|0.98|||Cox proportional hazard model|||||0.98|0.32|0.04
91732131|NCT01946880|183358942|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.068|0.214||||||||0.214|-0.068|
91732132|NCT01946880|183358944|OTHER||Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.116|0.279||||||||0.279|-0.116|
91732133|NCT01946880|183358945|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.091|0.36||||||||0.360|-0.091|
91732134|NCT01946880|183358946|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.07|||||TWO_SIDED|95.0|-0.475|0.333||||||||0.333|-0.475|
91732135|NCT01946880|183358947|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.286|0.249||||||The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.||0.249|-0.286|
91732136|NCT01946880|183358948|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.09|0.497||||||||0.497|-0.090|
91732137|NCT01946880|183358949|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.056|0.211||||||||0.211|-0.056|
91732138|NCT01946880|183358950|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.12|||||TWO_SIDED|95.0|-0.041|0.284||||||||0.284|-0.041|
91732139|NCT01946880|183358951|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.04|||||TWO_SIDED|95.0|-0.285|0.206||||||||0.206|-0.285|
91732140|NCT01946880|183358952|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.118|0.289||||||||0.289|-0.118|
91732141|NCT01946880|183358953|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.05|||||TWO_SIDED|95.0|-0.103|0.212||||||||0.212|-0.103|
91732142|NCT01946880|183358956|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.028|0.149||||||||0.149|-0.028|
91732143|NCT01946880|183358957|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.02|0.134||||||||0.134|-0.020|
91494001|NCT02002091|182859567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Fisher Exact|||||||0.038
91494002|NCT02002091|182859569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917|||||||Chi-squared, Corrected|||||||0.917
91494003|NCT02002091|182859570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.816|||||||Chi-squared, Corrected|||||||0.816
91494004|NCT02002091|182859571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Statistical significance : p\< 0.05|Fisher Exact|||||||0.008
91494005|NCT02002091|182859573|OTHER|||||||0.025||||||The threshold of statistical difference is P-value \< 0.05|Chi-squared, Corrected|||||||0.025
91732144|NCT01946880|183358958|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 24.||0.1|-0.1|
91732145|NCT01946880|183358958|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 48.||0.1|-0.1|
91732146|NCT01946880|183358958|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 60.||0.1|-0.2|
91732147|NCT01946880|183358959|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.019|0.059||||||||0.059|-0.019|
91732148|NCT01946880|183358961|OTHER||Mean Difference (Final Values)|1.61|||||TWO_SIDED|95.0|-2.24|5.45|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 24.||5.45|-2.24|
91732149|NCT01946880|183358961|OTHER||Mean Difference (Final Values)|2.54|||||TWO_SIDED|95.0|-1.13|6.21|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 48.||6.21|-1.13|
91494006|NCT02002091|182859576|OTHER|||||||0.059||||||the threshold for statistical significance used is P-value \<0.05|Fisher Exact|||||||0.059
91494007|NCT01233258|182859583|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as only 1 primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.||||0.0001
91732150|NCT01946880|183358961|OTHER||Mean Difference (Final Values)|3.55|||||TWO_SIDED|95.0|-0.17|7.28|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 60.||7.28|-0.17|
91732151|NCT01946880|183358962|OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.82|2.92|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 24.||2.92|-1.82|
91732152|NCT01946880|183358962|OTHER||Mean Difference (Final Values)|1.44|||||TWO_SIDED|95.0|-1.14|4.03|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 48.||4.03|-1.14|
91732153|NCT01946880|183358962|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|95.0|-0.71|4.67|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 60.||4.67|-0.71|
91732154|NCT01946880|183358963|OTHER||Mean Difference (Final Values)|1.65|||||TWO_SIDED|95.0|-1.03|4.32|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 24.||4.32|-1.03|
91732155|NCT01946880|183358963|OTHER||Mean Difference (Final Values)|2.17|||||TWO_SIDED|95.0|-0.69|5.02|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 48.||5.02|-0.69|
91732156|NCT01946880|183358963|OTHER||Mean Difference (Final Values)|3.02|||||TWO_SIDED|95.0|0.22|5.82|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 60.||5.82|0.22|
91732157|NCT03131479|183359040|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-9.21||||0.154|TWO_SIDED|90.0|-19.88|1.45|||Regression, Logistic|An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.||||1.45|-19.88|0.154
91732158|NCT03131479|183359040|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-6.05||||0.343|TWO_SIDED|90.0|-16.65|4.55|||Regression, Logistic|||||4.55|-16.65|0.343
91732159|NCT03131479|183359040|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-21.5||||0.001|TWO_SIDED|90.0|-31.79|4.55|||Regression, Logistic|||||4.55|-31.79|0.001
91494008|NCT01233258|182859584|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as this is not primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
91494009|NCT01233258|182859585|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
91494010|NCT01233258|182859586|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 10%|Median Difference (Net)|-0.0001||||0.0001|ONE_SIDED|95.0|-0.049|||No multiplicity adjustment as not primary endpoint.|Exact Permutation Test for paired sample||Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ|Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.|||-0.0490|0.0001
91528768|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|21.19||||||95.0|18.98|23.65|||||V116/PPSV23|Serotype 24F: V116/PPSV23 GMC Ratio||23.65|18.98|
91528769|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.69|||||TWO_SIDED|95.0|7.82|9.65|||||V116/PPSV23|Serotype 31: V116/PPSV23 GMC Ratio||9.65|7.82|
91732160|NCT03131479|183359040|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-35.6||||0|TWO_SIDED|90.0|-46.0|-25.11|||Regression, Logistic|||||-25.11|-46.00|0.000
91732161|NCT04439903|183359053|OTHER||Intercept|1.9726|STANDARD_ERROR_OF_MEAN|3.8238||0.61532|TWO_SIDED||||||Regression, Linear|||||||0.61532
91732162|NCT04439903|183359053|OTHER||Slope|-0.68016|STANDARD_ERROR_OF_MEAN|1.0084||0.5128|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.5128
91732163|NCT04439903|183359053|OTHER||Slope|0.15238|STANDARD_ERROR_OF_MEAN|0.3629||0.68197|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.68197
91732164|NCT04439903|183359054|OTHER||Intercept|-0.49527|STANDARD_ERROR_OF_MEAN|0.44535||0.28789|TWO_SIDED||||||Regression, Linear|||||||0.28789
91732165|NCT04439903|183359054|OTHER||Slope|0.16785|STANDARD_ERROR_OF_MEAN|0.11745||0.17848|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.17848
91732166|NCT04439903|183359054|OTHER||Slope|-0.06091|STANDARD_ERROR_OF_MEAN|0.042266||0.17514|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.17514
91732167|NCT04439903|183359055|OTHER||Intercept|-0.28825|STANDARD_ERROR_OF_MEAN|0.59949||0.63929|TWO_SIDED||||||Regression, Linear|||||||0.63929
91732168|NCT04439903|183359055|OTHER||Slope|-0.14422|STANDARD_ERROR_OF_MEAN|0.1581||0.37964|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.37964
91732169|NCT04439903|183359055|OTHER||Slope|0.06718|STANDARD_ERROR_OF_MEAN|0.056895||0.26057|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.26057
91732170|NCT01111552|183359056|SUPERIORITY||Treatment Difference|-1.3|||=|0.595|TWO_SIDED|95.0|-5.9|3.4|||ANCOVA|||||3.4|-5.9|=0.595
91732171|NCT01111552|183359056|SUPERIORITY||Treatment Difference|0.4|||=|0.869|TWO_SIDED|95.0|-4.4|5.1|||ANCOVA|||||5.1|-4.4|=0.869
91732172|NCT01111552|183359057|SUPERIORITY||Treatment Difference|-0.1|||=|0.856|TWO_SIDED|95.0|-0.7|0.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.6|-0.7|=0.856
91732173|NCT01111552|183359057|SUPERIORITY||Treatment Difference|0.1|||=|0.838|TWO_SIDED|95.0|-0.6|0.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.7|-0.6|=0.838
91732174|NCT01111552|183359058|SUPERIORITY||Treatment Difference|-0.2|||=|0.765|TWO_SIDED|95.0|-1.6|1.2|||ANCOVA|||||1.2|-1.6|=0.765
91732175|NCT01111552|183359058|SUPERIORITY||Treatment Difference|0.2|||=|0.76|TWO_SIDED|95.0|-1.2|1.6|||ANCOVA|||||1.6|-1.2|=0.760
91732176|NCT05135754|183359059|SUPERIORITY||Risk Ratio (RR)|0.59||||0.046|TWO_SIDED|95.0|0.35|0.99|||Mixed Models Analysis|||||0.99|0.35|0.046
91732177|NCT05135754|183359060|SUPERIORITY||Mean Difference (Final Values)|6.61|||<|0.001|TWO_SIDED|95.0|3.45|9.78|||Mixed Models Analysis|||||9.78|3.45|<0.001
91732178|NCT05135754|183359061|SUPERIORITY||Mean Difference (Final Values)|20.01|||<|0.001|TWO_SIDED|95.0|15.02|25.0|||Mixed Models Analysis|||||25.00|15.02|<0.001
91732179|NCT05135754|183359062|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED|95.0|2.71|9.94|||Mixed Models Analysis|||||9.94|2.71|<0.001
91732180|NCT05135754|183359063|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|8.26|20.35|||Mixed Models Analysis|||||20.35|8.26|<0.001
91732181|NCT05135754|183359064|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
91732182|NCT05135754|183359065|SUPERIORITY||Mean Difference (Final Values)|4.68||||0.004|TWO_SIDED|95.0|1.55|7.81|||Mixed Models Analysis|||||7.81|1.55|0.004
91732183|NCT00373360|183359066|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
91732184|NCT00373360|183359067|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.008
91732185|NCT00373360|183359068|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
91732186|NCT00373360|183359069|SUPERIORITY_OR_OTHER|||||||0.531||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.531
91732187|NCT00373360|183359070|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
91732188|NCT00373360|183359071|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.500
91732189|NCT00373360|183359072|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
91732190|NCT00373360|183359073|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||1.000
91732191|NCT00373360|183359074|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0
91732192|NCT00373360|183359075|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
91732193|NCT00373360|183359076|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
91732194|NCT00373360|183359077|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
91732195|NCT00373360|183359078|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
91732196|NCT00373360|183359079|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.063
91732197|NCT00373360|183359080|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Wilcoxon signed rank test|||Change Between Baseline and Week 8||||0.203
91732198|NCT00373360|183359084|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||0.250
91732199|NCT00373360|183359085|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.207
91732200|NCT00373360|183359086|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.297
91732201|NCT00373360|183359087|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
91759178|NCT04038567|183411374|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|-3.25|7.91||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.91|-3.25|
91759179|NCT04038567|183411374|SUPERIORITY||Mean Difference (Final Values)|4.82|||||TWO_SIDED|95.0|-0.76|10.4||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||10.40|-0.76|
91759180|NCT04038567|183411374|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-5.6|5.56||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||5.56|-5.60|
91494011|NCT00602797|182859631|OTHER|An interim analysis was conducted after 10 patients were accrued. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.|Proportion|6.0|||||TWO_SIDED||||||||If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated.|Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).||||
91494012|NCT00418457|182859657|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.74|1.28|||Regression, Cox|||||1.28|0.74|0.84
91494013|NCT00418457|182859658|SUPERIORITY||Odds Ratio (OR)|1.0||||0.7|TWO_SIDED|95.0|0.85|1.17|||GEE|||||1.17|0.85|0.70
91494014|NCT00418457|182859659|SUPERIORITY||Odds Ratio (OR)|0.98||||0.81|TWO_SIDED|95.0|0.75|1.28|||GEE|||||1.28|0.75|0.81
91494015|NCT00418457|182859660|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.96|TWO_SIDED|95.0|-0.63|0.6|||Mixed Models Analysis|||||0.60|-0.63|0.96
91494016|NCT00418457|182859661|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.043|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.043
91494017|NCT03736447|182859666|SUPERIORITY||Risk Difference (RD)|67.2|||<|0.0001|TWO_SIDED|95.0|50.0|84.5|||Farrington-Manning test|||||84.5|50.0|<0.0001
91494018|NCT03736447|182859667|SUPERIORITY||Risk Difference (RD)|64.2|||<|0.0001|TWO_SIDED|95.0|47.0|81.4|||Farrington-Manning test|||||81.4|47.0|<0.0001
91494019|NCT03736447|182859668|SUPERIORITY||Risk Difference (RD)|56.7|||<|0.0001|TWO_SIDED|95.0|39.8|73.5|||Farrington-Manning test|||||73.5|39.8|<0.0001
91494020|NCT02795832|182859679|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|12.441||0.5016|TWO_SIDED|90.0|-21.24|21.34||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Observed case||21.34|-21.24|0.5016
91494021|NCT02795832|182859679|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-3.01|STANDARD_ERROR_OF_MEAN|12.964||0.4082|TWO_SIDED|90.0|-24.39|18.36||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Multiple imputations||18.36|-24.39|0.4082
91494022|NCT02795832|182859679|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-18.27|STANDARD_ERROR_OF_MEAN|13.138||0.0878|TWO_SIDED|90.0|-40.65|4.11||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Last observation carried forward||4.11|-40.65|0.0878
91494023|NCT02795832|182859679|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-37.6|STANDARD_ERROR_OF_MEAN|18.748||0.0275|TWO_SIDED|90.0|-69.53|-5.66||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Worst case imputation||-5.66|-69.53|0.0275
91494024|NCT02795832|182859680|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-11.72||||0.1284|TWO_SIDED|90.0|-28.85|5.51||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 5||5.51|-28.85|0.1284
91494025|NCT02795832|182859680|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-5.95||||0.2765|TWO_SIDED|90.0|-22.85|10.95||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 8||10.95|-22.85|0.2765
91528770|NCT05569954|182933496|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|15.53|||||TWO_SIDED|95.0|14.13|17.07|||||V116/PPSV23|Serotype 35B: V116/PPSV23 GMC Ratio||17.07|14.13|
91494026|NCT02795832|182859680|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-6.01||||0.2765|TWO_SIDED|90.0|-23.08|11.06||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 10||11.06|-23.08|0.2765
91494027|NCT02795832|182859680|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05||||0.5016|TWO_SIDED|90.0|-21.24|21.34|||ANCOVA|||Day 15||21.34|-21.24|0.5016
91494028|NCT02795832|182859681|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|1.55||||0.4789|TWO_SIDED|90.0|0.28|10.75||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI 50||10.75|0.28|0.4789
91494029|NCT02795832|182859681|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|2.0||||0.3|TWO_SIDED|90.0|0.24|999.0||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI-75||999|0.24|0.3000
91494030|NCT02795832|182859682|SUPERIORITY||Odds Ratio (OR)|0.45||||0.5|TWO_SIDED|95.0|0.01|19.2||Results for the ZPL-5212372 and placebo groups are estimated adjusted LS means from the fitted model.|Shapiro-Wilkes test|The p-value tests if the residuals are normally distributed.||||19.20|0.01|0.500
91494031|NCT02795832|182859683|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.22||0.5233|TWO_SIDED|90.0|-2.02|2.16|||Shapiro-Wilkes test|||||2.16|-2.02|0.5233
91528771|NCT02708433|182933500|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|49.0||0.74|TWO_SIDED|95.0|-0.49|0.57|||Wilcoxon (Mann-Whitney)|||||0.57|-0.49|0.74
91528772|NCT02708433|182933501|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|48.0||0.5|TWO_SIDED|95.0|-0.89|0.52|||Wilcoxon (Mann-Whitney)|||||0.52|-0.89|0.5
91701651|NCT02266472|183298032|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|99.12|STANDARD_DEVIATION|12.9|<|0.0001|TWO_SIDED|90.0|93.69|104.87|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||104.87|93.69|<0.0001
91701652|NCT02266472|183298033|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|108.58|STANDARD_DEVIATION|9.3|<|0.0001|TWO_SIDED|90.0|104.17|113.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||113.17|104.17|<0.0001
91701653|NCT02266472|183298034|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|98.89|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|96.18|101.67|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.67|96.18|
91701654|NCT02266472|183298035|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|101.37|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|96.53|106.45|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.45|96.53|
91701655|NCT03197324|183298037|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|100.4|||||TWO_SIDED|90.0|86.49|116.56|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||116.56|86.49|
91701656|NCT03197324|183298040|SUPERIORITY|Compare if co-administration of digoxin with bexagliflozin had significant impact on the PK of digoxin|Ratio of Geometric LSM|106.12|||||TWO_SIDED|90.0|95.82|117.53|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||117.53|95.82|
91701657|NCT00710684|183298051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.279|TWO_SIDED|95.0|-1.9|0.5|||mixed model for repeated measures (MMRM)|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15mg versus placebo at Week 24||0.5|-1.9|0.279
91701658|NCT00710684|183298051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.012|TWO_SIDED|95.0|-2.7|-0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35mg versus placebo at Week 24||-0.3|-2.7|0.012
91701659|NCT00710684|183298052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.711|TWO_SIDED|95.0|-0.4|0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.3|-0.4|0.711
91701660|NCT00710684|183298052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.462|TWO_SIDED|95.0|-0.5|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||0.2|-0.5|0.462
91732202|NCT00637156|183359104|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.113||||1|TWO_SIDED|95.0|0.022|0.201||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.201|0.022|1.000
91701661|NCT00710684|183298053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.174|TWO_SIDED|95.0|-5.8|1.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||1.1|-5.8|0.174
91701662|NCT00710684|183298053|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.776|TWO_SIDED|95.0|-3.6|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||2.7|-3.6|0.776
91701663|NCT00710684|183298054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.7|-1.2|0.631
91701664|NCT00710684|183298054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.006|TWO_SIDED|95.0|-2.2|-0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||-0.4|-2.2|0.006
91494032|NCT02795832|182859684|SUPERIORITY||Odds Ratio (OR)|2.43||||0.2455|TWO_SIDED|95.0|0.45|13.26|||t-test, 1 sided|||||13.26|0.45|0.2455
91494033|NCT02795832|182859685|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|4.521||0.2812|TWO_SIDED|90.0|-10.4|5.09||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|Shapiro-Wilkes test|||||5.09|-10.40|0.2812
91494034|NCT03547583|182859729|OTHER||Difference of LS-means|-0.52|||=|0.8008|TWO_SIDED|97.5|-5.17|4.13|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||4.13|-5.17|= 0.8008
91494035|NCT03547583|182859729|OTHER||Difference of LS-means|-1.46|||=|0.4722|TWO_SIDED|97.5|-6.02|3.1|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||3.10|-6.02|= 0.4722
91494036|NCT03547583|182859730|OTHER||Difference of LS-means|-1.81|||=|0.8054|TWO_SIDED|97.5|-18.3|14.67|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||14.67|-18.30|= 0.8054
91494037|NCT03547583|182859730|OTHER||Difference of LS-means|-5.49|||=|0.4502|TWO_SIDED|97.5|-21.77|10.8|||mixed model repeated measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||10.80|-21.77|= 0.4502
91494038|NCT01269463|182859767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
91494039|NCT01269463|182859768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
91494040|NCT02657915|182859772|SUPERIORITY||Mean Difference (Final Values)|-6.0|||=|0.165|TWO_SIDED|95.0|-14.56|2.57|||ANCOVA|||||2.57|-14.56|=0.165
91494041|NCT04518306|182859785|SUPERIORITY||LS Means Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.451|<|0.0001|TWO_SIDED|95.0|-10.176|-4.486||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ¼ GMRx2 and placebo at Week 4||-4.486|-10.176|<0.0001
91494042|NCT04518306|182859785|SUPERIORITY||LS Means Difference|-8.23|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|-11.305|-5.151||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ½ GMRx2 and placebo at Week 4||-5.151|-11.305|<0.0001
91494043|NCT04518306|182859786|SUPERIORITY||LS Means Difference|-7.98|STANDARD_ERROR_OF_MEAN|1.649|<|0.0001|TWO_SIDED|95.0|-11.281|-4.681||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-4.681|-11.281|<0.0001
91494044|NCT04518306|182859786|SUPERIORITY||LS Means Difference|-9.52|STANDARD_ERROR_OF_MEAN|2.034|<|0.0001|TWO_SIDED|95.0|-13.588|5.449||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||5.449|-13.588|<0.0001
91528773|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.8|3.9||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||3.9|-3.8|
91494045|NCT04518306|182859787|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.204||0.0015|TWO_SIDED|95.0|-6.413|-1.597||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-1.597|-6.413|0.0015
91494046|NCT04518306|182859787|SUPERIORITY||LS Means Difference|-4.86|STANDARD_ERROR_OF_MEAN|1.133|<|0.0001|TWO_SIDED|95.0|-7.13|-2.595||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.595|-7.130|<0.0001
91494047|NCT04518306|182859788|SUPERIORITY||Risk Difference (RD)|28.09||||0.0002|TWO_SIDED|95.0|11.811|42.45|||Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||42.450|11.811|0.0002
91494048|NCT04518306|182859788|SUPERIORITY||Risk Difference (RD)|33.24|||<|0.0001|TWO_SIDED|95.0|17.199|47.186|||Wald test||95% confidence intervals for risk difference utilize Newcombe estimation method|||47.186|17.199|<0.0001
91494049|NCT04518306|182859789|SUPERIORITY||Risk Difference (RD)|17.18|||<|0.0001|TWO_SIDED|95.0|6.07|26.385||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method.|Percentages were calculated from the total number of participants within the randomized set.||26.385|6.070|<0.0001
91494050|NCT04518306|182859789|SUPERIORITY||Risk Difference (RD)|27.08|||<|0.0001|TWO_SIDED|95.0|15.237|36.646||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|Percentages were calculated from the total number of participants within the randomized set||36.646|15.237|<0.0001
91528774|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.1|3.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.7|-7.1|
91732203|NCT00637156|183359104|SUPERIORITY_OR_OTHER|||||||0.993||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.993
91732204|NCT00637156|183359105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.088||||1|TWO_SIDED|95.0|0.012|0.167||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.167|0.012|1.000
91732205|NCT00637156|183359105|SUPERIORITY_OR_OTHER|||||||0.99||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.990
91732206|NCT00637156|183359106|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.05||||1|TWO_SIDED|95.0|-0.014|0.119||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.119|-0.014|1.000
91732207|NCT00637156|183359106|SUPERIORITY_OR_OTHER|||||||0.931||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.931
91732208|NCT00637156|183359107|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.021||||1|TWO_SIDED|95.0|-0.019|0.062||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.062|-0.019|1.000
91732209|NCT00637156|183359107|SUPERIORITY_OR_OTHER|||||||0.852||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.852
91732210|NCT00637156|183359108|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.008||||0.997|TWO_SIDED|95.0|-0.073|0.056||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.056|-0.073|0.997
91732211|NCT00637156|183359108|SUPERIORITY_OR_OTHER|||||||0.395||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.395
91494051|NCT04518306|182859790|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.978|-2.013||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.013|-5.978|0.0002
91494052|NCT04518306|182859790|SUPERIORITY||LS Means Difference|-5.51|STANDARD_ERROR_OF_MEAN|0.908|<|0.0001|TWO_SIDED|95.0|-7.328|-3.694||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-3.694|-7.328|<0.0001
91494053|NCT04518306|182859791|SUPERIORITY||LS Means Difference|-6.79|STANDARD_ERROR_OF_MEAN|1.752||0.0003|TWO_SIDED|95.0|-10.3|-3.287||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-3.287|-10.300|0.0003
91732212|NCT00637156|183359109|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.024||||1|TWO_SIDED|95.0|-0.042|0.088||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.088|-0.042|1.000
91732213|NCT00637156|183359109|SUPERIORITY_OR_OTHER|||||||0.767||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.767
91732214|NCT00637156|183359110|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.024||||0.945|TWO_SIDED|95.0|-0.12|0.067||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.067|-0.120|0.945
91732215|NCT00637156|183359111|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.017||||0.997|TWO_SIDED|95.0|-0.072|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.072|0.997
91732216|NCT00637156|183359111|SUPERIORITY_OR_OTHER|||||||0.271||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.271
91732217|NCT00637156|183359112|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.013||||1|TWO_SIDED|95.0|-0.013|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.013|1.000
91732218|NCT00637156|183359112|SUPERIORITY_OR_OTHER|||||||0.859||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.859
91732219|NCT00637156|183359113|SUPERIORITY_OR_OTHER||Posterior Mean Difference|0.4||||0|TWO_SIDED|95.0|0.252|0.548||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.548|0.252|0.0
91732220|NCT00637156|183359114|SUPERIORITY_OR_OTHER||Posterior Mean Difference|11.5||||0.02|TWO_SIDED|95.0|0.56|22.44|||Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||22.440|0.560|0.02
91494054|NCT04518306|182859791|SUPERIORITY||LS Means Difference|-8.74|STANDARD_ERROR_OF_MEAN|1.829|<|0.0001|TWO_SIDED|95.0|-12.403|-5.082||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-5.082|-12.403|<0.0001
91494055|NCT04518306|182859792|SUPERIORITY||LS Means Difference|-3.86|STANDARD_ERROR_OF_MEAN|1.004||0.0003|TWO_SIDED|95.0|-5.865|-1.847||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-1.847|-5.865|0.0003
91494056|NCT04518306|182859792|SUPERIORITY||LS Means Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.245|<|0.0001|TWO_SIDED|95.0|-7.915|-2.932||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-2.932|-7.915|<0.0001
91494057|NCT04518306|182859793|SUPERIORITY||Risk Difference (RD)|35.48|||<|0.0001|TWO_SIDED|95.0|19.541|48.549||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||48.549|19.541|<0.0001
91494058|NCT04518306|182859793|SUPERIORITY||Risk Difference (RD)|29.97|||<|0.0001|TWO_SIDED|95.0|14.218|43.093||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||43.093|14.218|<0.0001
91494059|NCT04518306|182859794|SUPERIORITY||Risk Difference (RD)|17.21||||0.003|TWO_SIDED|95.0|3.637|28.424||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||28.424|3.637|0.0030
91494060|NCT04518306|182859794|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.0001|TWO_SIDED|95.0|8.72|33.665||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||33.665|8.720|<0.0001
91494061|NCT04518306|182859795|SUPERIORITY||Risk Difference (RD)|-1.61|||||TWO_SIDED|95.0|-9.83|2.76|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.760|-9.830|
91494062|NCT04518306|182859795|SUPERIORITY||Risk Difference (RD)|3.47|||||TWO_SIDED|95.0|-5.276|9.774|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.774|-5.276|
91732221|NCT00637156|183359115|SUPERIORITY_OR_OTHER||Posterior Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.258|0.058||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.058|-0.258|0.892
91732222|NCT04548219|183359135|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.907|||||TWO_SIDED|90.0|0.775|1.06||||||||1.06|0.775|
91732223|NCT04548219|183359136|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.761|1.1||||||||1.10|0.761|
91732224|NCT04548219|183359137|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.76|1.1||||||||1.10|0.760|
91494063|NCT04518306|182859796|SUPERIORITY||Risk Difference (RD)|-3.23|||||TWO_SIDED|95.0|-12.171|1.662|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||1.662|-12.171|
91494064|NCT04518306|182859796|SUPERIORITY||Risk Difference (RD)|-1.53|||||TWO_SIDED|95.0|-10.585|4.049||||||||4.049|-10.585|
91494065|NCT04518306|182859797|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.115|9.352|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.352|-4.115|
91494066|NCT04518306|182859797|SUPERIORITY||Risk Difference (RD)|5.08|||||TWO_SIDED|95.0|-2.779|11.2||||||||11.200|-2.779|
91494067|NCT04518306|182859798|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.012|9.35|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.350|-4.012|
91494068|NCT04518306|182859798|SUPERIORITY||Risk Difference (RD)|0.84|||||TWO_SIDED|95.0|-6.364|5.278|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.278|-6.364|
91494069|NCT04518306|182859799|SUPERIORITY||Risk Difference (RD)|-1.22|||||TWO_SIDED|95.0|-10.928|5.573|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||5.573|-10.928|
91494070|NCT04518306|182859799|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|1.38|9.53|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.53|1.38|
91494071|NCT04518306|182859800|SUPERIORITY||Risk Difference (RD)|1.95|||||TWO_SIDED|95.0|-6.492|7.954|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||7.954|-6.492|
91494072|NCT04518306|182859800|SUPERIORITY||Risk Difference (RD)|3.45|||||TWO_SIDED|95.0|-5.171|9.704|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.704|-5.171|
91494073|NCT04518306|182859801|SUPERIORITY||Risk Difference (RD)|0.88|||||TWO_SIDED|95.0|-6.324|5.548|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.548|-6.324|
91494074|NCT04518306|182859801|SUPERIORITY||number of participants at 95% CI|0.0|||||TWO_SIDED|95.0|0.0|3.05|||||For this particular parameter we have used number of participants at 95% CI computed from Clopper-Pearson method as no risk difference was found between the Triple ½ (GMRx2) vs placebo|||3.05|0.00|
91494075|NCT04518306|182859802|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.778|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.778|-9.684|
91494076|NCT04518306|182859802|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.59|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||2.590|-9.684|
91494077|NCT04518306|182859803|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|-6.722|12.959|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.959|-6.722|
91494078|NCT04518306|182859803|SUPERIORITY||Risk Difference (RD)|3.73|||||TWO_SIDED|95.0|-7.158|12.133|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.133|-7.158|
91732225|NCT02657356|183359185|SUPERIORITY||LS Mean difference (Net)|-12.86|STANDARD_ERROR_OF_MEAN|7.012||0.0683|TWO_SIDED|95.0|-26.69|0.98|||Mixed Models Analysis|Covariates: screening 6MWT, day 1 hemoglobin, treatment grp, # of PAH medications, time, interactions btwn treatment \& time, and screening 6MWT \& time|Difference is bardoxolone methyl - placebo|||0.98|-26.69|0.0683
91732226|NCT02657356|183359186|SUPERIORITY||Hazard Ratio (HR)|1.984||||0.0004|TWO_SIDED|95.0|1.36|2.895|||Chi-squared||Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \>1 indicates a beneficial effect that favors bardoxolone methyl.|||2.895|1.360|0.0004
91732227|NCT00834574|183359187|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.2|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|97.2|
91732228|NCT00834574|183359188|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
91732229|NCT00834574|183359189|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
91732230|NCT00500331|183359211|OTHER|Tukey's trend test for dose response: Change= Baseline+Treatment|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change= Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mg||||<0.001
91732231|NCT00500331|183359211|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg||||<0.001
91732232|NCT00500331|183359211|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg||||<0.001
91732233|NCT00500331|183359211|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg||||<0.001
91528775|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.1||||||95.0|-13.4|5.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||5.1|-13.4|
91732234|NCT00500331|183359211|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg||||<0.001
91732235|NCT00500331|183359211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.02|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 50 mg||-0.44|-1.02|<0.001
91732236|NCT00500331|183359211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.94|-0.35||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 100 mg||-0.35|-0.94|<0.001
91732237|NCT00500331|183359211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 250 mg||-0.44|-1.03|<0.001
91732238|NCT00500331|183359211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.19|-0.61||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 500 mg||-0.61|-1.19|<0.001
91732239|NCT00500331|183359211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.36|-0.77||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 1000 mg||-0.77|-1.36|<0.001
91732240|NCT00500331|183359211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76|||<|0.001|TWO_SIDED|95.0|-1.05|-0.47||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. Pioglitazone 30 mg||-0.47|-1.05|<0.001
91732241|NCT00856557|183359234|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is equal distribution of proportion of successful encounters among groups||||0.33
91701665|NCT00710684|183298054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.947|TWO_SIDED|95.0|-1.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||1.2|-1.3|0.947
91494079|NCT04518306|182859804|SUPERIORITY||Risk Difference (RD)|1.43|||||TWO_SIDED|95.0|-8.585|8.916||||||||8.916|-8.585|
91494080|NCT04518306|182859804|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-11.077|5.161||||||||5.161|-11.077|
91701666|NCT00710684|183298054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.5|0.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.0|-2.5|0.057
91701667|NCT00710684|183298054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.925|TWO_SIDED|95.0|-1.6|1.5|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.5|-1.6|0.925
91701668|NCT00710684|183298054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.024|TWO_SIDED|95.0|-3.1|-0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||-0.2|-3.1|0.024
91701669|NCT00710684|183298055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.387|TWO_SIDED|95.0|-0.4|0.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.1|-0.4|0.387
91701670|NCT00710684|183298055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.018|TWO_SIDED|95.0|-0.5|-0.1|||MMRM|||SB-742457 35 mg versus placebo at Week 12||-0.1|-0.5|0.018
91701671|NCT00710684|183298055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.439|TWO_SIDED|95.0|-0.3|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||0.6|-0.3|0.439
91701672|NCT00710684|183298055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.336|TWO_SIDED|95.0|-0.6|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.2|-0.6|0.336
91701673|NCT00710684|183298055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.8|-0.2|0.190
91701674|NCT00710684|183298055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.787|TWO_SIDED|95.0|-0.5|0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||0.4|-0.5|0.787
91701675|NCT00710684|183298056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.337|TWO_SIDED|95.0|-4.0|1.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||1.4|-4.0|0.337
91701676|NCT00710684|183298056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.596|TWO_SIDED|95.0|-1.7|3.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.0|-1.7|0.596
91701677|NCT00710684|183298056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.634|TWO_SIDED|95.0|-4.4|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||2.7|-4.4|0.634
91701678|NCT00710684|183298056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1||||0.238|TWO_SIDED|95.0|-1.4|5.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||5.6|-1.4|0.238
91701679|NCT00710684|183298056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.292|TWO_SIDED|95.0|-6.0|1.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.8|-6.0|0.292
91701680|NCT00710684|183298056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.161|TWO_SIDED|95.0|-1.0|6.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||6.2|-1.0|0.161
91701681|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.396|TWO_SIDED|95.0|-0.8|2.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||2.1|-0.8|0.396
91701682|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.019|TWO_SIDED|95.0|0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.2|0.3|0.019
91701683|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.11|TWO_SIDED|95.0|-0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||3.2|-0.3|0.110
91701684|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.024|TWO_SIDED|95.0|0.3|3.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||3.7|0.3|0.024
91701685|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.944|TWO_SIDED|95.0|-2.1|2.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo ate Week 36||2.0|-2.1|0.944
91701686|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.037|TWO_SIDED|95.0|0.1|3.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||3.8|0.1|0.037
91528776|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.3||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.3|-3.2|
91528777|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.1||||||95.0|-4.5|7.1||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated||7.1|-4.5|
91528778|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
91732242|NCT00856557|183359234|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.724|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED||||||Mixed Models Analysis|||Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)||||.036
91732243|NCT00856557|183359235|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.99
91732244|NCT00856557|183359236|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.39
91732245|NCT02301897|183359237|SUPERIORITY|||||||0.0008|||||||Chi-Square Test|||||||0.0008
91732246|NCT02301897|183359237|SUPERIORITY||||||<|0.001|||||||Chi-Square Test|||||||<0.001
91732247|NCT02301897|183359238|SUPERIORITY|||||||0.0719|||||||Chi-Square Test|||||||0.0719
91732248|NCT02301897|183359238|SUPERIORITY|||||||0.0004|||||||Chi-Square Test|||||||0.0004
91732249|NCT02301897|183359239|SUPERIORITY|||||||0.0167|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.0167
91528779|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||3.2|-3.2|
91732250|NCT02301897|183359239|SUPERIORITY|||||||0.1257|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.1257
91732251|NCT02301897|183359239|SUPERIORITY|||||||0.9754|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.9754
91732252|NCT02301897|183359239|SUPERIORITY|||||||0.7672|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.7672
91732253|NCT02301897|183359239|SUPERIORITY|||||||0.2232|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.2232
91732254|NCT02301897|183359239|SUPERIORITY|||||||0.4512|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.4512
91732255|NCT02301897|183359239|SUPERIORITY|||||||0.3545|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.3545
91732256|NCT02301897|183359239|SUPERIORITY|||||||0.2482|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.2482
91732257|NCT02301897|183359240|SUPERIORITY|||||||0.0016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0016
91732258|NCT02301897|183359240|SUPERIORITY|||||||0.0003|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0003
91732259|NCT02301897|183359240|SUPERIORITY|||||||0.6666|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.6666
91732260|NCT02301897|183359240|SUPERIORITY|||||||0.3612|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.3612
91732261|NCT02301897|183359240|SUPERIORITY|||||||0.0309|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0309
91732262|NCT02301897|183359240|SUPERIORITY|||||||0.0007|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0007
91732263|NCT02301897|183359240|SUPERIORITY|||||||0.0641|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.0641
91732264|NCT02301897|183359240|SUPERIORITY|||||||0.3743|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.3743
91732265|NCT02301897|183359241|SUPERIORITY|||||||0.0049|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0049
91732266|NCT02301897|183359241|SUPERIORITY|||||||0.0064|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0064
91732267|NCT02301897|183359241|SUPERIORITY|||||||0.5637|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5637
91528780|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.9|4.8||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||4.8|-7.9|
91701687|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.705|TWO_SIDED|95.0|-1.9|2.9|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||2.9|-1.9|0.705
91701688|NCT00710684|183298057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.088|TWO_SIDED|95.0|-0.3|4.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||4.2|-0.3|0.088
91701689|NCT00710684|183298058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.6|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.6|-0.6|0.962
91701690|NCT00710684|183298058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.134|TWO_SIDED|95.0|-0.1|1.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||1.0|-0.1|0.134
91701691|NCT00710684|183298058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.782|TWO_SIDED|95.0|-1.0|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.7|-1.0|0.782
91701692|NCT00710684|183298058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.268|TWO_SIDED|95.0|-0.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||1.2|-0.3|0.268
91701693|NCT02832375|183298069|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.577|-0.319|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|H0= no difference between experimental dentifrice and control dentifrice H1= a difference between experimental dentifrice and control dentifrice||-0.319|-0.577|<0.0001
91701694|NCT00514904|183298072|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] greater than or equal to (≥) -10%.|Difference in percentage|14.77|||||TWO_SIDED|95.0|10.26|20.23||||||||20.23|10.26|
91732268|NCT02301897|183359241|SUPERIORITY|||||||0.0505|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0505
91732269|NCT02301897|183359241|SUPERIORITY|||||||0.4262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4262
91701695|NCT00514904|183298072|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|24.47|||||TWO_SIDED|95.0|17.52|31.87||||||||31.87|17.52|
91701696|NCT00514904|183298072|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|6.35|||||TWO_SIDED|95.0|2.68|11.08|||Difference in percentage|||||11.08|2.68|
91701697|NCT00514904|183298072|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|23.92|||||TWO_SIDED|95.0|18.02|30.3||||||||30.3|18.02|
91701698|NCT00514904|183298073|NON_INFERIORITY|Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.|Risk Ratio (RR)|3.34||||0.2202|TWO_SIDED|95.0|0.56|20.25|||Chi-squared|||||20.25|0.56|0.2202
91732270|NCT02301897|183359241|SUPERIORITY|||||||0.1419|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1419
91732271|NCT02301897|183359241|SUPERIORITY|||||||0.4497|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4497
91732272|NCT02301897|183359241|SUPERIORITY|||||||0.5371|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5371
91732273|NCT02301897|183359242|SUPERIORITY|||||||0.0069|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0069
91732274|NCT02301897|183359242|SUPERIORITY|||||||0.0059|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0059
91732275|NCT02301897|183359242|SUPERIORITY|||||||0.2117|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2117
91732276|NCT02301897|183359242|SUPERIORITY|||||||0.0006|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0006
91732277|NCT02301897|183359242|SUPERIORITY|||||||0.0788|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0788
91732278|NCT02301897|183359242|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0080
91732279|NCT02301897|183359242|SUPERIORITY|||||||0.1516|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1516
91732280|NCT02301897|183359242|SUPERIORITY|||||||0.0565|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.0565
91494081|NCT04518306|182859805|SUPERIORITY||Risk Difference (RD)|-3.82|||<|0.0001|TWO_SIDED|95.0|-17.664|8.366|||GEE procedure|||||8.366|-17.664|<0.0001
91494082|NCT04518306|182859805|SUPERIORITY||LS Means|5.42|||<|0.0001|TWO_SIDED|95.0|-9.04|17.981|||GEE procedure|||||17.981|-9.040|<0.0001
91494083|NCT03268954|182859806|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.557|TWO_SIDED|95.0|0.757|1.238|||Log Rank|P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|IPSS-R indicates the Revised International Prognostic Scoring System.||1.238|0.757|=0.557
91732281|NCT02301897|183359243|SUPERIORITY|||||||0.011|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0110
91732282|NCT02301897|183359243|SUPERIORITY|||||||0.0601|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0601
91732283|NCT02301897|183359243|SUPERIORITY|||||||0.2168|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2168
91732284|NCT02301897|183359243|SUPERIORITY|||||||0.0101|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0101
91732285|NCT02301897|183359243|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2430
91732286|NCT02301897|183359243|SUPERIORITY|||||||0.0843|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0843
91732287|NCT02301897|183359243|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
91732288|NCT02301897|183359243|SUPERIORITY|||||||0.5302|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5302
91732289|NCT02301897|183359244|SUPERIORITY|||||||0.0504|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0504
91494084|NCT03268954|182859807|SUPERIORITY||Hazard Ratio (HR)|0.888|||=|0.152|TWO_SIDED|95.0|0.709|1.113||P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival (OS)||1.113|0.709|=0.152
91513292|NCT01975389|182898141|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.678061|TWO_SIDED|95.0|0.72|1.67|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.67|0.72|0.678061
91513293|NCT01975389|182898142|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.010457|TWO_SIDED|95.0|0.63|0.94|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.94|0.63|0.010457
91732290|NCT02301897|183359244|SUPERIORITY|||||||0.0151|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0151
91732291|NCT02301897|183359244|SUPERIORITY|||||||0.5932|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5932
91732292|NCT02301897|183359244|SUPERIORITY|||||||0.0831|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0831
91732293|NCT02301897|183359244|SUPERIORITY|||||||0.1416|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1416
91732294|NCT02301897|183359244|SUPERIORITY|||||||0.0392|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0392
91513294|NCT01975389|182898143|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.509847|TWO_SIDED|95.0|0.71|2.01|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||2.01|0.71|0.509847
91513295|NCT01975389|182898144|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002981|TWO_SIDED|95.0|0.58|0.9|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.90|0.58|0.002981
91513296|NCT01975389|182898145|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.748975|TWO_SIDED|95.0|0.7|1.3|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.30|0.70|0.748975
91513297|NCT01975389|182898146|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.626157|TWO_SIDED|95.0|0.63|1.32|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.32|0.63|0.626157
91732295|NCT02301897|183359244|SUPERIORITY|||||||0.8275|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8275
91732296|NCT02301897|183359244|SUPERIORITY|||||||0.8733|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8733
91732297|NCT02301897|183359245|SUPERIORITY|||||||0.0651|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0651
91732298|NCT02301897|183359245|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0298
91732299|NCT02301897|183359245|SUPERIORITY|||||||0.4005|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4005
91732300|NCT02301897|183359245|SUPERIORITY|||||||0.1114|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.1114
91732301|NCT02301897|183359245|SUPERIORITY|||||||0.1318|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1318
91732302|NCT02301897|183359245|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
91732303|NCT02301897|183359245|SUPERIORITY|||||||0.4506|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4506
91732304|NCT02301897|183359245|SUPERIORITY|||||||0.4614|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4614
91732305|NCT02301897|183359246|SUPERIORITY|||||||0.0653|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0653
91732306|NCT02301897|183359246|SUPERIORITY|||||||0.048|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0480
91732307|NCT02301897|183359246|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4010
91732308|NCT02301897|183359246|SUPERIORITY|||||||0.0772|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0772
91732309|NCT02301897|183359246|SUPERIORITY|||||||0.3206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.3206
91528781|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
91528782|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.1||||||95.0|-10.0|3.4||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated||3.4|-10.0|
91528783|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-0.5|7.6||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated||7.6|-0.5|
91732310|NCT02301897|183359246|SUPERIORITY|||||||0.1605|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1605
91732311|NCT02301897|183359246|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
91732312|NCT02301897|183359246|SUPERIORITY|||||||0.3437|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.3437
91732313|NCT02301897|183359247|SUPERIORITY|||||||0.2624|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2624
91732314|NCT02301897|183359247|SUPERIORITY|||||||0.0688|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0688
91732315|NCT02301897|183359247|SUPERIORITY|||||||0.279|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2790
91732316|NCT02301897|183359247|SUPERIORITY|||||||0.6541|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6541
91732317|NCT02301897|183359247|SUPERIORITY|||||||0.8559|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.8559
91528784|NCT00384059|182933504|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.0||||||95.0|-4.1|6.5||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||6.5|-4.1|
91732318|NCT02301897|183359247|SUPERIORITY|||||||0.4326|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4326
91732319|NCT02301897|183359247|SUPERIORITY|||||||0.1052|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1052
91732320|NCT02301897|183359247|SUPERIORITY|||||||0.9206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.9206
91732321|NCT02301897|183359248|SUPERIORITY|||||||0.1439|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1439
91528785|NCT00384059|182933505|SUPERIORITY_OR_OTHER||Difference|-5.3||||||95.0|-19.7|8.8||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.8|-19.7|
91528786|NCT00384059|182933505|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-8.0|8.1||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.1|-8.0|
91732322|NCT02301897|183359248|SUPERIORITY|||||||0.067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0670
91732323|NCT02301897|183359248|SUPERIORITY|||||||0.6761|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6761
91732324|NCT02301897|183359248|SUPERIORITY|||||||0.0639|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0639
91732325|NCT02301897|183359248|SUPERIORITY|||||||0.2218|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2218
91732326|NCT02301897|183359248|SUPERIORITY|||||||0.4468|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4468
91732327|NCT02301897|183359248|SUPERIORITY|||||||0.7678|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7678
91732328|NCT02301897|183359248|SUPERIORITY|||||||0.8922|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8922
91732329|NCT02301897|183359249|SUPERIORITY|||||||0.1262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1262
91732330|NCT02301897|183359249|SUPERIORITY|||||||0.2075|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2075
91732331|NCT02301897|183359249|SUPERIORITY|||||||0.5904|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5904
91732332|NCT02301897|183359249|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2430
91732333|NCT02301897|183359249|SUPERIORITY|||||||0.7067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.7067
91732334|NCT02301897|183359249|SUPERIORITY|||||||0.2725|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2725
91732335|NCT02301897|183359249|SUPERIORITY|||||||0.7016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7016
91732336|NCT02301897|183359249|SUPERIORITY|||||||0.8751|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8751
91732337|NCT02301897|183359250|SUPERIORITY|||||||0.0338|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0338
91732338|NCT02301897|183359250|SUPERIORITY|||||||0.0004|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0004
91732339|NCT02301897|183359250|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0807
91732340|NCT02301897|183359250|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0142
91732341|NCT02301897|183359250|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
91732342|NCT02301897|183359250|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0142
91732343|NCT02301897|183359250|SUPERIORITY|||||||0.1859|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.1859
91494085|NCT03268954|182859812|SUPERIORITY||Hazard Ratio (HR)|1.037|||=|0.562|TWO_SIDED|95.0|0.66|1.63||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS Participants||1.630|0.660|=0.562
91494086|NCT03268954|182859812|SUPERIORITY||Hazard Ratio (HR)|1.512|||=|0.603|TWO_SIDED|95.0|0.068|33.773||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR CMML Participants||33.773|0.068|=0.603
91494087|NCT03268954|182859812|SUPERIORITY||Hazard Ratio (HR)|1.034|||=|0.558|TWO_SIDED|95.0|0.663|1.61||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML/MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS/CMML Participants||1.610|0.663|=0.558
91701699|NCT00084318|183298087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.05|TWO_SIDED|95.0|0.54|1.06|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \[RTOG = Radiation Therapy Oncology Group\]||1.06|0.54|0.05
91701700|NCT00084318|183298087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.5|0.96|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.||0.96|0.50|0.01
91701701|NCT00084318|183298088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.5|1.03|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.03|0.5|0.04
91701702|NCT00084318|183298088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.001|TWO_SIDED|95.0|0.39|0.82|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.||0.82|0.39|0.001
91701703|NCT00084318|183298092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.63|1.76|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.76|0.63|0.66
91701704|NCT00084318|183298092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.86|TWO_SIDED|95.0|0.72|1.87|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.||1.87|0.72|0.86
91701705|NCT05537792|183298096|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.579|||||||t-test, 1 sided|||||||0.579
91701706|NCT05537792|183298096|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.0008|||||||t-test, 1 sided|||||||0.0008
91732344|NCT02301897|183359250|SUPERIORITY|||||||0.0896|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.0896
91732345|NCT02069847|183359294|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
91528787|NCT00384059|182933506|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.5|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.8|-3.5|
91701707|NCT05537792|183298096|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.5513|||||||t-test, 1 sided|||||||0.5513
91701708|NCT05537792|183298096|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.00034|||||||t-test, 1 sided|||||||0.00034
91732346|NCT02069847|183359295|SUPERIORITY|||||||0.531|||||||t-test, 2 sided|||Total number of budesonide subjects with 50% or greater esophageal stricture (N=4) vs total number of control subjects with 50% or greater esophageal structure (N=15)||||0.531
91732347|NCT00557440|183359305|SUPERIORITY_OR_OTHER||LS Mean Difference|0.165|STANDARD_ERROR_OF_MEAN|0.0492||0.001|TWO_SIDED|95.0|0.066|0.263||Statistical significance (two-sided) at 5% level. p-values were not corrected for multiplicity.|ANCOVA|Treatment, period, sequence and center as fixed effects, period baseline FEV1 as a covariate, and patient nested within sequence as a random effect.||||0.263|0.066|0.001
91732348|NCT04507763|183359310|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
91701709|NCT00224406|183298120|SUPERIORITY||Mean Difference (Final Values)|5.022||||0.8541|ONE_SIDED|95.0||50.26|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at ICU Admission (Time 0).||50.26||0.8541
91701710|NCT00224406|183298120|SUPERIORITY||Mean Difference (Final Values)|10.426||||0.6996|ONE_SIDED|95.0||55.17|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at 24 Hours Post ICU Admission.||55.17||0.6996
91701711|NCT00224406|183298121|SUPERIORITY||Mean Difference (Final Values)|4.377||||0.8654|ONE_SIDED|95.0||47.15|||t-test, 1 sided|||ICU Admission (Time 0)||47.15||0.8654
91701712|NCT00224406|183298121|SUPERIORITY||Median Difference (Final Values)|13.386||||0.6789|ONE_SIDED|95.0||66.91|||t-test, 1 sided|||24 Hours Post ICU Admission||66.91||0.6789
91701713|NCT00224406|183298121|SUPERIORITY||Mean Difference (Final Values)|-19.968||||0.6345|ONE_SIDED|95.0||49.56|||t-test, 1 sided|||48 Hours Post ICU Admission||49.56||0.6345
91701714|NCT00224406|183298121|SUPERIORITY||Mean Difference (Final Values)|0.908||||0.9858|ONE_SIDED|95.0||85.49|||t-test, 1 sided|||72 Hours Post ICU Admission||85.49||0.9858
91701715|NCT00224406|183298122|SUPERIORITY||Odds Ratio (OR)|2.867||||0.7985|TWO_SIDED|95.0|0.727|11.302|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at ICU Admission (Time 0). One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||11.302|0.727|0.7985
91701716|NCT00224406|183298122|SUPERIORITY||Odds Ratio (OR)|0.837||||0.5606|TWO_SIDED|95.0|0.226|3.092|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 24h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||3.092|0.226|0.5606
91701717|NCT00224406|183298122|SUPERIORITY||Odds Ratio (OR)|1.716||||0.8786|TWO_SIDED|95.0|0.531|5.552|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 48h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.552|0.531|0.8786
91701718|NCT00224406|183298122|SUPERIORITY||Odds Ratio (OR)|1.337||||0.8499|TWO_SIDED|95.0|0.352|5.072|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 72h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.072|0.352|0.8499
91701719|NCT00224406|183298123|SUPERIORITY|at 24 hrs from mechanical ventilation|difference in event probability|0.0091||||0.7076|TWO_SIDED|95.0|-0.1867|0.2049|||Log Rank|||||0.2049|-0.1867|0.7076
91701720|NCT00224406|183298123|SUPERIORITY||difference in event probability|-0.0316||||0.7076|TWO_SIDED|95.0|-0.2092|0.146|||Log Rank|||at 48 hrs from mechanical ventilation||0.1460|-0.2092|0.7076
91701721|NCT00224406|183298123|SUPERIORITY||difference in event probability|-0.0661||||0.7076|TWO_SIDED|95.0|-0.2314|0.0993|||Log Rank|||at 72 hrs from mechanical ventilation||0.0993|-0.2314|0.7076
91701722|NCT00224406|183298124|SUPERIORITY||Difference in event probability|-0.0364||||0.9632|TWO_SIDED|95.0|-0.0858|0.0131|||Log Rank|||Analysis at 24 hours||0.0131|-0.0858|0.9632
91701723|NCT00224406|183298124|SUPERIORITY||Difference in event probability|0.0352||||0.9632|TWO_SIDED|95.0|-0.1458|0.2162|||Log Rank|||Analysis at 48 h||0.2162|-0.1458|0.9632
91701724|NCT00224406|183298124|SUPERIORITY||Difference in event probability|-0.0179||||0.9632|TWO_SIDED|95.0|-0.2143|0.1785|||Log Rank|||analysis at 72 h||0.1785|-0.2143|0.9632
91701725|NCT00224406|183298129|SUPERIORITY||Difference in event probability|-0.0566||||0.0111|TWO_SIDED|95.0|-0.1188|0.0056|||Log Rank|||Herein analysis up to month 3 was reported.||0.0056|-0.1188|0.0111
91732349|NCT04507763|183359311|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
91701726|NCT00224406|183298129|SUPERIORITY||Difference in event probability|-0.0943||||0.0111|TWO_SIDED|95.0|-0.173|-0.0156|||Log Rank|||Herein analysis up to month 6 was reported.||-0.0156|-0.1730|0.0111
91701727|NCT00224406|183298129|SUPERIORITY||Difference in event probability|-0.1132||||0.0111|TWO_SIDED|95.0|-0.1985|-0.0279|||Log Rank|||Herein analysis up to month 9 was reported.||-0.0279|-0.1985|0.0111
91701728|NCT00224406|183298129|SUPERIORITY||Slope|-0.1334||||0.0111|TWO_SIDED|95.0|-0.2254|-0.0413|||Log Rank|||Herein analysis up to month 12 was reported.||-0.0413|-0.2254|0.0111
91701729|NCT01010009|183298132|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||>0.05
91701730|NCT01010009|183298132|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||<0.05
91701731|NCT01010009|183298133|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
91701732|NCT01010009|183298133|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
91701733|NCT01010009|183298134|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
91701734|NCT01010009|183298134|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
91701735|NCT03315455|183298158|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.016|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.016|<0.0001
91759181|NCT04038567|183411375|SUPERIORITY||Mean Difference (Final Values)|3.18|||||TWO_SIDED|95.0|-3.01|9.37||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||9.37|-3.01|
91732350|NCT03322566|183359312|SUPERIORITY||Difference in Percentages|-18.5||||0.9948|TWO_SIDED|95.0|-32.0|-4.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen method||Stratified by PD-L1 TPS ( \<50% vs. \>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \>= 50 percent Non-squamous' and 'TPS \>= 50% Squamous' were combined into one stratum.|||-4.3|-32.0|0.9948
91732351|NCT03322566|183359313|OTHER||Hazard Ratio (HR)|1.47||||0.94305|TWO_SIDED|95.0|0.91|2.36||One-sided p-value based on log-rank test stratified by TPS (\<50% vs \>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \>= 50% Non-squamous' and 'TPS \>= 50% Squamous' were combined into one.|Regression, Cox|Efron's method of tie handling||||2.36|0.91|0.94305
91732352|NCT03322566|183359314|OTHER||Hazard Ratio (HR)|1.9||||0.96272|TWO_SIDED|95.0|0.93|3.9||One-sided p-value based on log-rank test stratified by PD-L1 TPS (\<50% vs \>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\<50% vs \>=50%) were combined into one stratum.|Regression, Cox|||||3.90|0.93|0.96272
91732353|NCT06045273|183359358|SUPERIORITY||Slope|0.224|STANDARD_ERROR_OF_MEAN|0.064||0.0006|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0006
91494088|NCT03268954|182859813|SUPERIORITY||Absolute Rate Difference|-4.18|||=|0.374|TWO_SIDED|95.0|-13.18|4.83||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants With Complete Remission (CR) and CR+Complete Remission with Incomplete Blood Count Recovery (CRi)||4.83|-13.18|=0.374
91701736|NCT03315455|183298158|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.015|0.082||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.082|0.015|<0.0001
91701737|NCT03315455|183298161|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.026|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.026|<0.0001
91701738|NCT03315455|183298161|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.092||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.092|0.028|<0.0001
91701739|NCT03315455|183298164|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.053||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.053|0.006|<0.0001
91701740|NCT03315455|183298164|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.007|0.059||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.059|0.007|<0.0001
91701741|NCT03315455|183298167|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.017|0.102||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.102|0.017|<0.0001
91701742|NCT03315455|183298167|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.013|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.013|<0.0001
91732354|NCT06045273|183359359|SUPERIORITY||Slope|0.084|STANDARD_ERROR_OF_MEAN|0.043||0.0504|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0504
91701743|NCT03315455|183298170|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.163||Not controlled for Type I error|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|||0.163|0.016|<0.0001
91701744|NCT03315455|183298170|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.011|0.122||Not controlled for Type I error|ABR Ratio||The ABR ratio was calculated as Arm B vs. Arm C.|||0.122|0.011|<0.0001
91701745|NCT03315455|183298175|SUPERIORITY||Difference in Adjusted Means|14.68||||0.0515|TWO_SIDED|95.0|-0.1|29.46||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||29.46|-0.10|0.0515
91701746|NCT03315455|183298175|SUPERIORITY||Difference in Adjusted Means|18.33||||0.0204|TWO_SIDED|95.0|2.97|33.68||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||33.68|2.97|0.0204
91732355|NCT06045273|183359360|SUPERIORITY||Slope|0.131|STANDARD_ERROR_OF_MEAN|0.04||0.00134|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.00134
91732356|NCT02947048|183359365|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.42||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.61
91732357|NCT02947048|183359365|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.52||0.33|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.33
91732358|NCT02947048|183359365|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.47||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.61
91732359|NCT02947048|183359365|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.43||0.91|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.91
91732360|NCT03895372|183359406|SUPERIORITY||Risk Difference (RD)|8.87||||0.2621|TWO_SIDED|90.0|-4.5|26.26||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||26.26|-4.50|0.2621
91732361|NCT03895372|183359406|SUPERIORITY||Risk Difference (RD)|4.76||||0.2621|TWO_SIDED|90.0|-7.07|21.48||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||21.48|-7.07|0.2621
91732362|NCT03895372|183359406|SUPERIORITY||Risk Difference (RD)|33.02||||0.0004|TWO_SIDED|90.0|18.01|47.11||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||47.11|18.01|0.0004
91732363|NCT03895372|183359406|SUPERIORITY||Risk Difference (RD)|46.46|||<|0.0001|TWO_SIDED|90.0|30.62|60.56||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||60.56|30.62|<0.0001
91732364|NCT03895372|183359414|SUPERIORITY||Risk Difference (RD)|3.9|||||TWO_SIDED|90.0|-11.82|23.42||||||The analysis was based on the data at Week 16.||23.42|-11.82|
91732365|NCT03895372|183359414|SUPERIORITY||Risk Difference (RD)|-4.76|||||TWO_SIDED|90.0|-18.61|13.29||||||The analysis was based on the data at Week 16.||13.29|-18.61|
91732366|NCT03895372|183359414|SUPERIORITY||Risk Difference (RD)|32.38|||||TWO_SIDED|90.0|14.32|47.52||||||The analysis was based on the data at Week 16.||47.52|14.32|
91732367|NCT03895372|183359414|SUPERIORITY||Risk Difference (RD)|58.89|||||TWO_SIDED|90.0|41.01|72.41||||||The analysis was based on the data at Week 16.||72.41|41.01|
91732368|NCT03895372|183359415|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
91732369|NCT03895372|183359415|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
91732370|NCT03895372|183359415|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
91732371|NCT03895372|183359415|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
91732372|NCT03895372|183359416|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
91732373|NCT03895372|183359416|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
91732374|NCT03895372|183359416|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
91732375|NCT03895372|183359416|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
91732376|NCT03895372|183359419|SUPERIORITY||Least Squares Mean Difference|-1.46|||||TWO_SIDED|90.0|-5.42|2.51||||||The analysis was based on the data at Week 16.||2.51|-5.42|
91732377|NCT03895372|183359419|SUPERIORITY||Least Squares Mean Difference|-3.54|||||TWO_SIDED|90.0|-7.5|0.42||||||The analysis was based on the data at Week 16.||0.42|-7.50|
91732378|NCT03895372|183359419|SUPERIORITY||Least Squares Mean Difference|-9.8|||||TWO_SIDED|90.0|-13.05|-6.56||||||The analysis was based on the data at Week 16.||-6.56|-13.05|
91732379|NCT03895372|183359419|SUPERIORITY||Least Squares Mean Difference|-12.33|||||TWO_SIDED|90.0|-15.61|-9.04||||||The analysis was based on the data at Week 16.||-9.04|-15.61|
91732380|NCT03895372|183359420|SUPERIORITY||Least Squares Mean Difference|-8.63|||||TWO_SIDED|90.0|-23.61|6.35||||||The analysis was based on the data at Week 16.||6.35|-23.61|
91732381|NCT03895372|183359420|SUPERIORITY||Least Squares Mean Difference|-13.02|||||TWO_SIDED|90.0|-27.98|1.94||||||The analysis was based on the data at Week 16.||1.94|-27.98|
91732382|NCT03895372|183359420|SUPERIORITY||Least Squares Mean Difference|-40.74|||||TWO_SIDED|90.0|-53.02|-28.46||||||The analysis was based on the data at Week 16.||-28.46|-53.02|
91732383|NCT03895372|183359420|SUPERIORITY||Least Squares Mean Difference|-53.04|||||TWO_SIDED|90.0|-65.44|-40.63||||||The analysis was based on the data at Week 16.||-40.63|-65.44|
91732384|NCT03895372|183359421|SUPERIORITY||Least Squares Mean Difference|-1.22|||||TWO_SIDED|90.0|-2.52|0.09||||||The analysis was based on the data at Week 16.||0.09|-2.52|
91732385|NCT03895372|183359421|SUPERIORITY||Least Squares Mean Difference|-1.21|||||TWO_SIDED|90.0|-2.46|0.05||||||The analysis was based on the data at Week 16.||0.05|-2.46|
91732386|NCT03895372|183359421|SUPERIORITY||Least Squares Mean Difference|-3.47|||||TWO_SIDED|90.0|-4.51|-2.43||||||The analysis was based on the data at Week 16.||-2.43|-4.51|
91732387|NCT03895372|183359421|SUPERIORITY||Least Squares Mean Difference|-3.66|||||TWO_SIDED|90.0|-4.71|-2.61||||||The analysis was based on the data at Week 16.||-2.61|-4.71|
91732388|NCT03895372|183359422|SUPERIORITY||Risk Difference (RD)|12.99|||||TWO_SIDED|90.0|-4.52|32.87||||||The analysis was based on the data at Week 16.||32.87|-4.52|
91732389|NCT03895372|183359422|SUPERIORITY||Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|2.62|44.64||||||The analysis was based on the data at Week 16.||44.64|2.62|
91732390|NCT03895372|183359422|SUPERIORITY||Risk Difference (RD)|41.27|||||TWO_SIDED|90.0|23.47|56.18||||||The analysis was based on the data at Week 16.||56.18|23.47|
91732391|NCT03895372|183359422|SUPERIORITY||Risk Difference (RD)|49.13|||||TWO_SIDED|90.0|30.62|63.69||||||The analysis was based on the data at Week 16.||63.69|30.62|
91732392|NCT03895372|183359423|SUPERIORITY||Least Squares Mean Difference|-4.21|||||TWO_SIDED|90.0|-7.82|-0.59||||||The analysis was based on the data at Week 16.||-0.59|-7.82|
91732393|NCT03895372|183359423|SUPERIORITY||Least Squares Mean Difference|-6.44|||||TWO_SIDED|90.0|-9.89|-2.99||||||The analysis was based on the data at Week 16.||-2.99|-9.89|
91732394|NCT03895372|183359423|SUPERIORITY||Least Squares Mean Difference|-10.51|||||TWO_SIDED|90.0|-13.4|-7.62||||||The analysis was based on the data at Week 16.||-7.62|-13.40|
91732395|NCT03895372|183359423|SUPERIORITY||Least Squares Mean Difference|-10.81|||||TWO_SIDED|90.0|-13.68|-7.94||||||The analysis was based on the data at Week 16.||-7.94|-13.68|
91701747|NCT03315455|183298177|SUPERIORITY||Difference in Adjusted Means|6.06||||0.3281|TWO_SIDED|95.0|-6.27|18.4||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||18.40|-6.27|0.3281
91732396|NCT03685149|183359431|SUPERIORITY||percent reduction|72.0|||<|0.0001|TWO_SIDED|95.0|56.0|82.0|||Mixed Models Analysis|||||82|56|<0.0001
91701748|NCT03315455|183298177|SUPERIORITY||Difference in Adjusted Means|14.01||||0.0297|TWO_SIDED|95.0|1.44|26.59||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||26.59|1.44|0.0297
91701749|NCT03315455|183298180|SUPERIORITY||Difference in Adjusted Means|-3.46||||0.6165|TWO_SIDED|95.0|-17.23|10.31||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||10.31|-17.23|0.6165
91701750|NCT03315455|183298180|SUPERIORITY||Difference in Adjusted Means|-7.58||||0.2797|TWO_SIDED|95.0|-21.48|6.33||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||6.33|-21.48|0.2797
91701751|NCT03315455|183298182|SUPERIORITY||Difference in Adjusted Means|-0.05||||0.489|TWO_SIDED|95.0|-0.18|0.09||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||0.09|-0.18|0.4890
91701752|NCT03315455|183298182|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.2454|TWO_SIDED|95.0|-0.22|0.06||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||0.06|-0.22|0.2454
91701753|NCT02407132|183298201|SUPERIORITY|||||||0.038||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.038
91701754|NCT02407132|183298202|SUPERIORITY|||||||0.234||||||The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.234
91701755|NCT02407132|183298203|SUPERIORITY|||||||0.019||||||The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.019
91701756|NCT02407132|183298204|SUPERIORITY|||||||0.186||||||The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.186
91701757|NCT02407132|183298205|SUPERIORITY|||||||0.04||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.040
91701758|NCT02407132|183298206|SUPERIORITY|||||||0.312||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed Effects Logistic Regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.312
91701759|NCT02407132|183298207|SUPERIORITY|||||||0.622||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.622
91701760|NCT02407132|183298208|SUPERIORITY|||||||0.957||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.957
91732397|NCT03685149|183359432|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
91732398|NCT03685149|183359433|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91494089|NCT03268954|182859818|SUPERIORITY||Absolute Rate Difference|-4.67|||=|0.329|TWO_SIDED|95.0|-13.72|4.39||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, Revised International Prognostic Scoring System (IPSS-R) risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR||4.39|-13.72|=0.329
91494090|NCT03268954|182859819|SUPERIORITY||Absolute Rate Difference|-0.44|||=|0.891|TWO_SIDED|95.0|-10.03|9.15||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR2||9.15|-10.03|=0.891
91494091|NCT03268954|182859820|SUPERIORITY||Hazard Ratio (HR)|0.679|||=|0.072|TWO_SIDED|95.0|0.402|1.146|||Log Rank|P-value was based on 1-sided log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of CR||1.146|0.402|=0.072
91494092|NCT03268954|182859821|SUPERIORITY||Hazard Ratio (HR)|0.846|||=|0.373|TWO_SIDED|95.0|0.306|2.339||P-value comparing duration of CR+CRi between treatment groups was based on 1-sided unstratified log-rank.|Log Rank||Hazard ratio was based on an unadjusted unstratified Cox proportional hazard regression model with treatment as a factor in the model.|Duration of Complete Remission + Complete Remission with Incomplete Blood Count Recovery (CRi)||2.339|0.306|=0.373
91494093|NCT03268954|182859822|SUPERIORITY||Hazard Ratio (HR)|0.889|||=|0.32|TWO_SIDED|95.0|0.542|1.458||P-value comparing duration of PR or better response between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response (OR)||1.458|0.542|=0.320
91494094|NCT03268954|182859823|SUPERIORITY||Hazard Ratio (HR)|0.796|||=|0.151|TWO_SIDED|95.0|0.514|1.231||P-value comparing duration of overall response 2 between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response 2 (OR2)||1.231|0.514|=0.151
91494095|NCT03268954|182859824|SUPERIORITY||Absolute Rate Difference|3.27|||=|0.573|TWO_SIDED|95.0|-9.02|15.55||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBC-transfusion Independence||15.55|-9.02|=0.573
91494096|NCT03268954|182859824|SUPERIORITY||Absolute Rate Difference|-3.43|||=|0.477|TWO_SIDED|95.0|-25.84|18.97||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||18.97|-25.84|=0.477
91494097|NCT03268954|182859825|SUPERIORITY||Hazard Ratio (HR)|1.231|||=|0.774|TWO_SIDED|95.0|0.715|2.119||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of RBC Transfusion Independence||2.119|0.715|=0.774
91732399|NCT03685149|183359434|SUPERIORITY|||||||0.207|||||||Wilcoxon (Mann-Whitney)|||||||0.207
91732400|NCT02034565|183359451|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.977|||||TWO_SIDED|90.0|0.756|1.261||||||||1.261|0.756|
91732401|NCT02034565|183359452|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.05|||||TWO_SIDED|90.0|0.938|1.176||||||||1.176|0.938|
91732402|NCT02034565|183359453|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.043|||||TWO_SIDED|90.0|0.933|1.167||||||||1.167|0.933|
91732403|NCT03232567|183359464|SUPERIORITY|||||||0.2451|||||||Fisher Exact|||||||0.2451
91513298|NCT01975389|182898147|SUPERIORITY||LS mean difference|-56.9|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-57.91|-55.89|||MMRM|||Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-55.89|-57.91|<0.001
91732404|NCT03232567|183359464|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
91732405|NCT03232567|183359464|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
91732406|NCT03232567|183359465|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||||||0.4828
91732407|NCT03232567|183359465|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
91732408|NCT03232567|183359465|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
91732409|NCT03232567|183359467|SUPERIORITY|||||||0.0169|||||||Fisher Exact|||NasoVAX low dose vs placebo||||0.0169
91732410|NCT03232567|183359467|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||NasoVAX medium dose vs placebo||||0.0063
91732411|NCT03232567|183359467|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||NasoVAX high dose vs placebo||||<0.0001
91732412|NCT02655601|183359469|SUPERIORITY||Hazard Ratio (HR)|0.791||||0.135|ONE_SIDED|95.0||95.0||Study was originally designed with 1 IA after approximately 42 deaths. An unplanned, 2nd IA was conducted to support a BTDR. The study was not terminated early as a result of either IAs. No further IA were conducted until the primary analysis.|Log Rank|89 study participants had passed away at the time of this analysis (41 in the RT/TMZ + BMX-001 arm and 48 in the Radiation Therapy/TMZ arm).||A 1-tailed logrank test was conducted at the 0.2 level. This test had 90% power to detect a hazard ratio of 0.63 after 84 deaths were observed among the 160 randomized patients.||95||0.135
91732413|NCT02655601|183359481|SUPERIORITY||Odds Ratio (OR)|0.45||||0.465|ONE_SIDED||||||Fisher Exact|||With 78 and 71 patients in Arms A and B, respectively, there was 80% power with a one-tailed chi-square test (α=0.05) to detect a reduction in grade 3 or 4 thrombocytopenia from 15% in Arm B (without BMX-001) to 3.7% in Arm A (with BMX-001). Given the small number of patients that experienced low platelet counts or thrombocytopenia, a one-tailed Fisher's exact test was performed instead.||||0.465
91732414|NCT02655601|183359482|SUPERIORITY||Hazard Ratio (HR)|0.978||||0.911|ONE_SIDED||||||Log Rank|||A 1-tailed logrank test was conducted at the 0.2 level.||||0.911
91732415|NCT02655601|183359483|SUPERIORITY|||||||0.401|||||||Chi-squared, Corrected|A continuity adjusted Chi-Squared test was performed.||||||0.401
91732416|NCT02014376|183359489|SUPERIORITY||||||=|0.3699|||||||Fisher Exact|||||||=0.3699
91528788|NCT00384059|182933506|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.3|2.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||2.8|-5.3|
91701761|NCT02407132|183298209|SUPERIORITY|||||||0.147||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.147
91701762|NCT02407132|183298210|SUPERIORITY|||||||0.326||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.326
91701763|NCT01846221|183298214|OTHER|||||||0.38|||||||ANOVA|||||||0.38
91701764|NCT02304380|183298233|OTHER||Difference in differences|-0.0064|||||TWO_SIDED|95.0|-0.0469|0.034|||||Linear model difference in incidences.|||0.0340|-0.0469|
91701765|NCT02304380|183298234|OTHER||Difference in Differences|0.0506|||||TWO_SIDED|95.0|0.029|0.0722|||||Linear model difference in incidences.|||0.0722|0.0290|
91701766|NCT02304380|183298235|OTHER||Difference in Differences|-0.0005|||||TWO_SIDED|95.0|-0.0109|0.0099|||||Linear model difference in incidences.|||0.0099|-0.0109|
91701767|NCT02304380|183298236|OTHER||Difference in differences|-0.0207|||||TWO_SIDED|95.0|-0.0318|0.0096||||||||0.0096|-0.0318|
91701768|NCT02304380|183298237|OTHER||Difference in differences|0.0163|||||TWO_SIDED|95.0|0.0036|0.0289|||||Linear model difference in incidences.|||0.0289|0.0036|
91701769|NCT02304380|183298238|OTHER||Difference in differences|0.0046|||||TWO_SIDED|95.0|-0.002|0.0111|||||||Linear model difference in incidences.|0.0111|-0.0020|
91701770|NCT02304380|183298239|OTHER||Difference in differences|0.0151|||||TWO_SIDED|95.0|-0.0129|0.0431|||||Linear model difference in incidences.|||0.0431|-0.0129|
91732417|NCT04011241|183359497|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|173.71|||||TWO_SIDED|90.0|154.58|195.21|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 17.6.|||195.21|154.58|
91701771|NCT02304380|183298240|OTHER||Difference in Differences|-0.0066|||||TWO_SIDED|95.0|-0.0328|0.0197|||||Linear model difference in incidences.|||0.0197|-0.0328|
91732418|NCT04011241|183359498|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|137.4|||||TWO_SIDED|90.0|120.84|156.24|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 19.4.|||156.24|120.84|
91732419|NCT04011241|183359499|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|168.64|||||TWO_SIDED|90.0|145.59|195.34|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 18.1.|||195.34|145.59|
91732420|NCT00086515|183359505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C||||-0.53|-0.77|<0.001
91701772|NCT02304380|183298241|OTHER||Difference in Differences|-0.0105|||||TWO_SIDED|95.0|-0.0374|0.0163|||||Linear model difference in incidences.|||0.0163|-0.0374|
91701773|NCT02304380|183298242|OTHER||Difference in Differences|0.0006|||||TWO_SIDED|95.0|-0.0031|0.0044|||||Linear model difference in incidences.|||0.0044|-0.0031|
91701774|NCT02304380|183298243|OTHER||Difference in Differences|-0.0293|||||TWO_SIDED|95.0|-0.1025|0.044||||Linear model difference in incidences.||||0.0440|-0.1025|
91701775|NCT02304380|183298244|OTHER||Difference in Differences|-0.0579|||||TWO_SIDED|95.0|-0.1492|0.0116|||||Linear model difference in incidences.|||0.0116|-0.1492|
91701776|NCT02304380|183298245|OTHER||Difference in differences|0.0072|||||TWO_SIDED|95.0|0.001|0.0134|||||Linear model difference in incidences.|||0.0134|0.0010|
91701777|NCT02304380|183298246|OTHER||Difference in Differences|0.0058|||||TWO_SIDED|95.0|0.0009|0.0107||||||||0.0107|0.0009|
91701778|NCT02304380|183298247|OTHER||Difference in Differences|0.0054|||||TWO_SIDED|95.0|0.0001|0.0106|||||Linear model difference in incidences.|||0.0106|0.0001|
91701779|NCT02304380|183298248|OTHER||Difference in Differences|-0.0039|||||TWO_SIDED|95.0|-0.0096|0.0017|||||Linear model difference in incidences.|||0.0017|-0.0096|
91701780|NCT02304380|183298249|OTHER||Difference in Differences|-0.011|||||TWO_SIDED|95.0|-0.0178|-0.0043|||||Linear model difference in incidences.|||-0.0043|-0.0178|
91701781|NCT02304380|183298250|OTHER||Difference in Differences|0.0026|||||TWO_SIDED|95.0|-0.0036|0.0086|||||Linear model difference in incidences.|||0.0086|-0.0036|
91701782|NCT02304380|183298251|OTHER||Difference in differences|0.0197|||||TWO_SIDED|95.0|0.011|0.0284|||||Linear model difference in incidences.|||0.0284|0.0110|
91701783|NCT00328094|183298255|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.23|TWO_SIDED|95.0|0.85|1.97|||Chi-squared|||||1.97|0.85|0.23
91701784|NCT01349322|183298258|NON_INFERIORITY|Non-inferiority is defined as a hazard ratio upper limit of 2.12.|Hazard Ratio (HR)|1.32||||0.039|TWO_SIDED|90.0|0.84|2.05|||Regression, Cox||Cause-specific hazard ratio; reference level = Arm 1.|"Assuming Arm 1 5-year IBR of 1.59%, for hypothesized upper bound hazard ratio (HR) of 2.12 (Arm 2 5-year IBR of 3.33%), 46 IBR events provide \>80% power to conclude non-inferiority with one-sided significance level = 0.05. Null hypothesis: HR ≥ 2.12 (inferior). Alternative hypothesis: HR \< 2.12 (non-inferior). See Limitations and Caveats section."||2.05|0.84|0.039
91701785|NCT01349322|183298259|SUPERIORITY|||||||0.96||||||Two-sided significance level = 0.05|Log Rank|||||||0.96
91701786|NCT01349322|183298260|SUPERIORITY|||||||0.14||||||Two-sided significance level = 0.05.|Log Rank|||||||0.14
91701787|NCT01349322|183298261|SUPERIORITY|||||||0.34||||||Two-sided significance level = 0.05|Log Rank|||||||0.34
91732421|NCT00086515|183359506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|||<|0.001|TWO_SIDED|95.0|-31.0|-19.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG||||-19.8|-31.0|<0.001
91494098|NCT03268954|182859825|SUPERIORITY||Hazard Ratio (HR)|1.533|||=|0.801|TWO_SIDED|95.0|0.567|4.147||P-value comparing duration of platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Platelet Transfusion Independence||4.147|0.567|=0.801
91701788|NCT01349322|183298263|NON_INFERIORITY|Null hypothesis (H0) of inferiority: the mean change in cosmetic subscale score in Arm 2 will be at least 0.4 standard deviations worse than in Arm 1. If H0 is rejected, then non-inferiority can be concluded.|Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.62|<|0.0001|TWO_SIDED|95.0|-0.08|0.13||One-side significance level = 0.025|t-test, 1 sided|||||0.13|-0.08|<0.0001
91732422|NCT00086515|183359507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001|TWO_SIDED|95.0|-60.5|-40.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG||||-40.8|-60.5|<0.001
91732423|NCT01618708|183359527|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.07|||=|0.7462|TWO_SIDED|95.0|-0.38|0.52||Threshold for significance at 0.05 level|Mixed Models Analysis||Placebo vs Synvisc-One|Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).||0.52|-0.38|= 0.7462
91732424|NCT02181413|183359561|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.582|0.89|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.|HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.|||0.890|0.582|0.002
91732425|NCT02181413|183359562|SUPERIORITY||Hazard Ratio (HR)|1.025||||0.85|TWO_SIDED|95.0|0.789|1.332||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.332|0.789|0.850
91732426|NCT02181413|183359563|SUPERIORITY||Odds Ratio (OR)|0.732||||0.37|TWO_SIDED|95.0|0.365|1.466||P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by pre-induction regimen, pre-induction international staging system (ISS), and response after transplantation at screening.|Cochran-Mantel-Haenszel||Odds ratio and CI are based on a logistic regression model with treatment group as a categorical predictor variable and pre-induction regimen, pre-induction ISS, and response after transplantation at screening as covariates.|CR||1.466|0.365|0.370
91732427|NCT02181413|183359564|SUPERIORITY||Hazard Ratio (HR)|0.716||||0.002|TWO_SIDED|95.0|0.579|0.886||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||0.886|0.579|0.002
91701789|NCT04076059|183298273|SUPERIORITY||Cox Proportional Hazard|0.13|||<|0.0001|TWO_SIDED|95.0|0.076|0.222|||Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|||0.222|0.076|<0.0001
91701790|NCT04076059|183298274|SUPERIORITY||Cox Proportional Hazard|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.556|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.556|0.196|<0.0001
91701791|NCT04076059|183298275|SUPERIORITY||Cox Proportional Hazard|0.789||||0.7279|TWO_SIDED|95.0|0.208|2.998|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||2.998|0.208|0.7279
91701792|NCT04076059|183298276|SUPERIORITY||Cox Proportional Hazard|0.172|||<|0.0001|TWO_SIDED|95.0|0.107|0.276|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.276|0.107|<0.0001
91732428|NCT02181413|183359565|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.902|TWO_SIDED|95.0|0.795|1.298||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.298|0.795|0.902
91732429|NCT02181413|183359566|SUPERIORITY||Hazard Ratio (HR)|0.833||||0.056|TWO_SIDED|95.0|0.69|1.005|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.005|0.690|0.056
91528789|NCT00384059|182933507|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.68|1.16||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.68|
91701793|NCT04076059|183298277|SUPERIORITY|||||||0.0036|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||0.0036
91701794|NCT04076059|183298278|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||<0.0001
91701795|NCT04076059|183298279|SUPERIORITY||Cox Proportional Hazard|0.797||||0.5899|TWO_SIDED|95.0|0.35|1.819|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||1.819|0.350|0.5899
91701796|NCT04076059|183298280|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|40.1|66.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||66.9|40.1|<0.0001
91494099|NCT03268954|182859825|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.45|TWO_SIDED|95.0|0.58|1.614||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Transfusion Independence||1.614|0.580|=0.450
91494100|NCT03268954|182859826|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.228|TWO_SIDED|95.0|0.628|1.234||P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)||1.234|0.628|=0.228
91732430|NCT02181413|183359567|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.431|TWO_SIDED|95.0|0.753|1.129||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage, and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.129|0.753|0.431
91701797|NCT04076059|183298281|SUPERIORITY||Difference in Percentage|-5.2||||0.8312|TWO_SIDED|95.0|-25.4|14.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||14.9|-25.4|0.8312
91701798|NCT04186806|183298282|NON_INFERIORITY|Non-inferiority margin was 1.5 cm|Mean Difference (Final Values)|-0.3426|||||TWO_SIDED|95.0|-1.2601|0.5749||The conclusion of the non-inferiority test is based on the 95% confidence interval and not on a p value. A p value was not computed.|Mixed Models Analysis||Non-inferiority testing was carried out using 95% confidence intervals.|||0.5749|-1.2601|
91701799|NCT02720744|183298341|SUPERIORITY||Mean Difference (Net)|6.13|||<|0.001|TWO_SIDED|95.0|3.52|8.75||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline (or its log transformation).|Difference from placebo was defined by the FT218 mean value minus placebo value.|||8.75|3.52|<0.001
91701800|NCT02720744|183298342|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.001|TWO_SIDED|95.0|2.76|11.23||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|GLIMMIX model|P-values estimated with categorized CGI-Improvement response (very much or much improved versus other category) at the specific visit.||||11.23|2.76|<0.001
91701801|NCT02720744|183298343|SUPERIORITY||Mean Difference (Net)|-6.65|||<|0.001|TWO_SIDED|95.0|-9.32|-3.98||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline to the end of the respective treatment period.||||-3.98|-9.32|<0.001
91701802|NCT02122770|183298344|SUPERIORITY||Geometric LS Mean Ratio|98.75|||||TWO_SIDED|90.0|82.6|118.05||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric least square (LS) means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.05|82.60|
91701803|NCT02122770|183298345|SUPERIORITY||Geometric LS Mean Ratio|110.21|||||TWO_SIDED|90.0|102.34|118.69||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.69|102.34|
91701804|NCT02122770|183298346|SUPERIORITY||Geometric LS Mean Ratio|110.66|||||TWO_SIDED|90.0|102.53|119.43||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||119.43|102.53|
91701805|NCT02122770|183298347|SUPERIORITY||Geometric LS Mean Ratio|113.05|||||TWO_SIDED|90.0|85.35|149.74||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||149.74|85.35|
91494101|NCT03268954|182859827|SUPERIORITY||Absolute Rate Difference|-5.46|||=|0.32|TWO_SIDED|95.0|-16.36|5.44||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Number of Participants With HI||5.44|-16.36|=0.320
91701806|NCT02122770|183298347|SUPERIORITY||Geometric LS Mean Ratio|159.55|||||TWO_SIDED|90.0|89.97|282.96||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||282.96|89.97|
91701807|NCT02122770|183298347|SUPERIORITY||Geometric LS Mean Ratio|77.26|||||TWO_SIDED|90.0|55.19|108.17||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||108.17|55.19|
91701808|NCT02122770|183298348|SUPERIORITY||Geometric LS Mean Ratio|121.57|||||TWO_SIDED|90.0|110.92|133.24||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||133.24|110.92|
91701809|NCT02122770|183298348|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
91701810|NCT02122770|183298348|SUPERIORITY||Geometric LS Mean Ratio|101.36|||||TWO_SIDED|90.0|90.72|113.23||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||113.23|90.72|
91701811|NCT02122770|183298349|SUPERIORITY||Geometric LS Mean Ratio|122.95|||||TWO_SIDED|90.0|112.13|134.82||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||134.82|112.13|
91701812|NCT02122770|183298349|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
91701813|NCT02122770|183298349|SUPERIORITY||Geometric LS Mean Ratio|100.89|||||TWO_SIDED|90.0|91.14|111.68||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||111.68|91.14|
91701814|NCT00767039|183298402|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|t-test, 2 sided|||Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive \>/= 3 days were included in the analysis.||||< 0.05
91701815|NCT00767039|183298403|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.43|||<|0.05|TWO_SIDED|95.0|0.19|0.95|||Mantel Haenszel|||||0.95|0.19|<0.05
91701816|NCT00767039|183298404|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
91701817|NCT00767039|183298405|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.05|TWO_SIDED|95.0|0.25|0.96|||Mantel Haenszel|||||0.96|0.25|<0.05
91701818|NCT00767039|183298406|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||<|0.01|TWO_SIDED|95.0|1.29|4.38|||Mantel Haenszel|||||4.38|1.29|<0.01
91701819|NCT00767039|183298407|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
91701820|NCT00767039|183298408|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
91701821|NCT00767039|183298409|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
91732431|NCT02181413|183359568|SUPERIORITY||Hazard Ratio (HR)|1.179|||||TWO_SIDED|95.0|0.959|1.45|||||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.450|0.959|
91494102|NCT03268954|182859828|SUPERIORITY||Rate Difference|2.64|||||TWO_SIDED|95.0|-0.3|5.58||||||Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML||5.58|-0.30|
91513299|NCT01975389|182898148|SUPERIORITY||LS mean difference|-73.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-75.11|-72.5|||MMRM|||LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-72.50|-75.11|<0.001
91701822|NCT00767039|183298410|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
91701823|NCT00767039|183298411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.44|||>|0.05|TWO_SIDED|95.0|0.71|2.89|||Mantel Haenszel|||||2.89|0.71|>0.05
91701824|NCT00767039|183298412|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||>|0.05|TWO_SIDED|90.0|0.84|2.63|||Mantel Haenszel|||||2.63|0.84|>0.05
91701825|NCT02505334|183298413|SUPERIORITY|Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||ANCOVA|||Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.||-0.24|-0.55|<0.0001
91701826|NCT02945254|183298507|SUPERIORITY|||||||0.011||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.011
91701827|NCT02945254|183298508|SUPERIORITY|||||||0.13||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.13
91701828|NCT01711619|183298509|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 4% was predefined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation of the proportion for ITT.||||<0.0001
91701829|NCT01711619|183298510|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Regression, Linear|||||||<0.0001
91701830|NCT01711619|183298511|SUPERIORITY_OR_OTHER|||||||0.0002||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||0.0002
91701831|NCT01711619|183298512|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||<0.0001
91701832|NCT00783224|183298513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
91701833|NCT00783224|183298513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
91701834|NCT03422159|183298514|NON_INFERIORITY|Based on the results of the preliminary study of Marik et al, 5 we projected that the combination of ascorbic acid, thiamine, and hydrocortisone could reduce time to vasopressor discontinuation from 54 (+/-30 hours) vs 30 hours. For the additional primary outcome, we projected a greater change of SOFA score of 4 (+/-3) vs 2. Assuming a type 1 error of 5% (alpha of 0.05) and a power of 80%, this study would require a sample size of 94 patients.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91701835|NCT01432275|183298548|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test|Comparison to 27 participants that preferred their usual method to FreeStyle InsuLinx. Twelve(12) participants did not have a preference.||||||<0.0001
91701836|NCT01935700|183298556|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in median survival between the colchicine group and the sorafenib treated group.||||||0.4593|||||||Mann-Whitney U test|||||||0.4593
91701837|NCT01935700|183298556|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in survival between the colchicine group and the sorafenib treated group.||||||0.329|||||||Log Rank|||||||0.3290
91701838|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0552||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pneumonia between two groups||||0.0552
91701839|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0184||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups||||0.0184
91701840|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0931||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of cholangitis between two groups||||0.0931
91701841|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0506||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of peritonitis between two groups||||0.0506
91701842|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of sepsis between two groups||||1
91701843|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5374||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of diarrhea between two groups||||0.5374
91701844|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of anorexia between two groups||||0.14
91701845|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.4584||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of abdominal pain between two groups||||0.4584
91701846|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of skin rash between two groups||||1
91732432|NCT02181413|183359570|SUPERIORITY|||||||0.814||||||P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.814
91701847|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups||||1
91701848|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypertension between two groups||||1
91701849|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5958||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hemorrhage between two groups||||0.5958
91701850|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypoglycemia between two groups||||0.14
91701851|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hyperglycemia between two groups||||1
91701852|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypocalcemia between two groups||||1
91701853|NCT01935700|183298557|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pleural effusion between two groups||||1
91701854|NCT00475878|183298558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.19|TWO_SIDED|95.0|0.33|1.24|||Chi-squared|||||1.24|.33|.19
91701855|NCT00475878|183298559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.16||0.18|TWO_SIDED|95.0|-2.79|5.84|||t-test, 2 sided|||||5.84|-2.79|.18
91701856|NCT01438814|183298586|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to 0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|<0.0001
91701857|NCT01438814|183298586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8924||95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|0.8924
91701858|NCT01438814|183298587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8201||95.0|0.672|1.37|||Regression, Logistic|Model includes treatment and continuous baseline HbA1c||||1.370|0.672|0.8201
91701859|NCT01438814|183298588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.022||||0.9397|TWO_SIDED|95.0|0.582|1.796|||Regression, Logistic|Model includes treatment and baseline HbA1c.||||1.796|0.582|0.9397
91732433|NCT02181413|183359571|SUPERIORITY|||||||0.805||||||P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.805
91732434|NCT02181413|183359572|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.034|TWO_SIDED|95.0|0.386|0.969||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||0.969|0.386|0.034
91732435|NCT02181413|183359572|SUPERIORITY||Hazard Ratio (HR)|0.704||||0.01|TWO_SIDED|95.0|0.539|0.92||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||0.920|0.539|0.010
91732436|NCT02181413|183359573|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.182|TWO_SIDED|95.0|0.414|1.184||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||1.184|0.414|0.182
91732437|NCT02181413|183359573|SUPERIORITY||Hazard Ratio (HR)|0.966||||0.847|TWO_SIDED|95.0|0.682|1.368||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||1.368|0.682|0.847
91732438|NCT02181413|183359574|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.905|TWO_SIDED|95.0|0.583|1.613||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.613|0.583|0.905
91732439|NCT02181413|183359579|SUPERIORITY||Least Squares (LS) Mean Difference|-2.3||||0.074|TWO_SIDED|95.0|-4.9|0.2|||t-test, 2 sided|P-value was from the significance test for the coefficient of the interaction between treatment and visit.||||0.2|-4.9|0.074
91732440|NCT04603560|183359634|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.66|||||The odds ratio represents Social Norming vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||1.66|0.54|
91732441|NCT04603560|183359634|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.72|2.29|||||The odds ratio represents Pharmacist E-Detailing vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||2.29|0.72|
91732442|NCT04603560|183359634|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.74|2.56|||||The odds ratio represents Pharmacist e-detailing vs Social Norming.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size.||2.56|0.74|
91494103|NCT03268954|182859829|SUPERIORITY||Hazard Ratio (HR)|0.858|||=|0.084|TWO_SIDED|95.0|0.689|1.067||P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.|Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death||1.067|0.689|=0.084
91732443|NCT03514134|183359643|SUPERIORITY||||||<|0.001|||||||ANCOVA|Repeated measures ANCOVA||||||<0.001
91732444|NCT03514134|183359644|SUPERIORITY|||||||0.358|||||||ANCOVA|Repeated measures ANCOVA||||||0.358
91732445|NCT03514134|183359645|SUPERIORITY|||||||0.029|||||||ANCOVA|Repeated measures ANCOVA||||||0.029
91732446|NCT03514134|183359646|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91732447|NCT03514134|183359646|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
91494104|NCT03268954|182859831|SUPERIORITY||Absolute Rate Difference|-2.85|||=|0.683|TWO_SIDED|95.0|-19.44|13.75||P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel|||OR: HR MDS/CMML Participants||13.75|-19.44|=0.683
91732448|NCT03514134|183359647|SUPERIORITY|||||||0.7||||||Group by time interaction|ANOVA|Repeated measures ANOVA||||||0.70
91732449|NCT00775658|183359668|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.||||0.57
91732450|NCT00775658|183359669|SUPERIORITY|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
91732451|NCT04033640|183359716|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
91732452|NCT01892189|183359719|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.2348|STANDARD_ERROR_OF_MEAN|0.20458||0.259|TWO_SIDED|95.0|-0.6506|0.1809|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.||0.1809|-0.6506|0.259
91732453|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0367|STANDARD_ERROR_OF_MEAN|0.22075||0.869|TWO_SIDED|95.0|-0.4853|0.4119|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4119|-0.4853|0.869
91701860|NCT01438814|183298589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.3352||95.0|-2.1|6.1|||ANCOVA|||||6.1|-2.1|0.3352
91494105|NCT03268954|182859831|SUPERIORITY||Absolute Rate Difference|2.36|||=|0.84|TWO_SIDED|95.0|-20.39|25.12||P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||ORR: Low-blast AML Participants||25.12|-20.39|=0.840
91494106|NCT03268954|182859832|SUPERIORITY||Hazard Ratio (HR)|0.877|||=|0.24|TWO_SIDED|95.0|0.608|1.263||P-value comparing EFS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.263|0.608|=0.240
91494107|NCT03268954|182859833|SUPERIORITY||Hazard Ratio (HR)|0.826|||=|0.145|TWO_SIDED|95.0|0.58|1.178||P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.178|0.580|=0.145
91494108|NCT03268954|182859834|SUPERIORITY||Absolute Rate Difference|-5.14|||=|0.261|TWO_SIDED|95.0|-13.95|3.68||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Overall Response for HR MDS/CMML||3.68|-13.95|=0.261
91528790|NCT00384059|182933508|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.54|1.08||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.54|
91701861|NCT01438814|183298590|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Fisher Exact|Fishers exact p-value presented due to small cell counts||||||0.0308
91701862|NCT01438814|183298591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0545||95.0|0.0|1.0|||ANCOVA|||||1.0|-0.0|0.0545
91701863|NCT01438814|183298592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.997||||0.9886||95.0|0.689|1.445|||Regression, Logistic|||||1.445|0.689|0.9886
91701864|NCT01438814|183298593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.2108||95.0|0.558|1.137|||Regression, Logistic|||||1.137|0.558|0.2108
91494109|NCT03268954|182859834|SUPERIORITY||Absolute Rate Difference|22.36|||=|0.026|TWO_SIDED|95.0|3.22|41.49||P-value was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Overall Response for Low-blast AML||41.49|3.22|=0.026
91494110|NCT03820986|182859872|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|0.81||||0.0176|TWO_SIDED|95.0|0.67|0.98|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||0.98|0.67|0.0176
91494111|NCT03820986|182859873|SUPERIORITY|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|1.2||||0.9521|TWO_SIDED|95.0|0.97|1.48|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.97|0.9521
91513300|NCT01975389|182898149|SUPERIORITY||LS mean difference|-39.31|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-40.55|-38.06|||ANCOVA|||LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.||-38.06|-40.55|<0.001
91701865|NCT01438814|183298594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.9972||95.0|0.712|1.402|||Regression, Logistic|||||1.402|0.712|0.9972
91701866|NCT01438814|183298595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.2816||95.0|0.594|1.163|||Regression, Logistic|||||1.163|0.594|0.2816
91701867|NCT01438814|183298596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0011||95.0|0.25|0.98|||ANCOVA|||||0.98|0.25|0.0011
91701868|NCT01438814|183298597|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.7682||95.0|0.681|1.328|||Regression, Logistic|||||1.328|0.681|0.7682
91701869|NCT03887429|183298608|SUPERIORITY||||||=|0.009|||||||t-test, 1 sided|||It was hypothesized that treatment with SXC-2023 would reduce impulsivity as measured by SSRT in chronic cigarette smokers abstaining from nicotine for 5 days.||||=.009
91701870|NCT03887429|183298609|SUPERIORITY||||||=|0.015|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would result in increased risk taking behavior as measured using DAVT in subjects receiving placebo as treatment.||||=.015
91701871|NCT03887429|183298609|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would not result in increased risk taking behavior as measured using DAVT in subjects treated with SXC-2023.||||>.1
91701872|NCT05238025|183298617|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|42.9|||||TWO_SIDED|95.0|-16.1|71.9||||||||71.9|-16.1|
91732454|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|0.20968||0.306|TWO_SIDED|95.0|-0.6441|0.2081|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2081|-0.6441|0.306
91759182|NCT04038567|183411375|SUPERIORITY||Mean Difference (Final Values)|1.28|||||TWO_SIDED|95.0|-4.92|7.47||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.47|-4.92|
91494112|NCT03820986|182859878|OTHER||Difference in LS means|-3.69||||0.0345|TWO_SIDED|95.0|-7.1|-0.27||No formal hypothesis testing was conducted. P-value is nominal.|cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a constrained longitudinal data analysis (cLDA) model with GHS/QoL as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate. No formal hypothesis testing was conducted. P-value is nominal.||-0.27|-7.10|0.0345
91494113|NCT03820986|182859879|OTHER||Difference in LS means|-5.49||||0.0004|TWO_SIDED|95.0|-8.53|-2.45|||cLDA model|No formal hypothesis testing was conducted. P-value is nominal.|Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a cLDA model with PF as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate. No formal hypothesis testing was conducted. P-value is nominal.||-2.45|-8.53|0.0004
91528791|NCT00384059|182933509|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.82|1.16||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.82|
91701873|NCT05238025|183298618|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the first primary outcome is met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|59.0|||||TWO_SIDED|95.0|34.7|74.3|||||Not formally tested, since the first primary outcome was not met|||74.3|34.7|
91528792|NCT00384059|182933509|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.83|1.17||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.83|
91732455|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2525|STANDARD_ERROR_OF_MEAN|0.17956||0.169|TWO_SIDED|95.0|-0.6174|0.1124|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1124|-0.6174|0.169
91732456|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0417|STANDARD_ERROR_OF_MEAN|0.19375||0.831|TWO_SIDED|95.0|-0.4354|0.3521|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3521|-0.4354|0.831
91732457|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2421|STANDARD_ERROR_OF_MEAN|0.18403||0.197|TWO_SIDED|95.0|-0.6161|0.1319|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1319|-0.6161|0.197
91732458|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1155|STANDARD_ERROR_OF_MEAN|0.1618||0.48|TWO_SIDED|95.0|-0.4443|0.2133|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2133|-0.4443|0.480
91732459|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1673|STANDARD_ERROR_OF_MEAN|0.17458||0.345|TWO_SIDED|95.0|-0.1875|0.5221|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5221|-0.1875|0.345
91732460|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1504|STANDARD_ERROR_OF_MEAN|0.16583||0.371|TWO_SIDED|95.0|-0.4874|0.1866|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1866|-0.4874|0.371
91732461|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1731|STANDARD_ERROR_OF_MEAN|0.18808||0.364|TWO_SIDED|95.0|-0.5553|0.2092|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2092|-0.5553|0.364
91732462|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.20294||0.507|TWO_SIDED|95.0|-0.2762|0.5486|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5486|-0.2762|0.507
91732463|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2464|STANDARD_ERROR_OF_MEAN|0.19276||0.21|TWO_SIDED|95.0|-0.6381|0.1453|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1453|-0.6381|0.210
91732464|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3059|STANDARD_ERROR_OF_MEAN|0.14253||0.039|TWO_SIDED|95.0|-0.5955|-0.0162|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0162|-0.5955|0.039
91732465|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0134|STANDARD_ERROR_OF_MEAN|0.1538||0.931|TWO_SIDED|95.0|-0.2991|0.326|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3260|-0.2991|0.931
91732466|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1164|STANDARD_ERROR_OF_MEAN|0.14608||0.431|TWO_SIDED|95.0|-0.4133|0.1804|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1804|-0.4133|0.431
91494114|NCT03820986|182859880|OTHER||Hazard Ratio (HR)|1.58||||0.0001|TWO_SIDED|95.0|1.25|2.0|||Log Rank|No formal hypothesis testing was conducted. P-value is nominal.|HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown) No formal hypothesis testing was conducted. P-value is nominal.||2.00|1.25|0.0001
91494115|NCT03820986|182859881|OTHER||Hazard Ratio (HR)|1.95||||0.0001|TWO_SIDED|95.0|1.52|2.5|||Log Rank|No formal hypothesis testing was conducted. P-value is nominal.|HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown). No formal hypothesis testing was conducted. P-value is nominal.||2.50|1.52|.0001
91513301|NCT01975389|182898150|SUPERIORITY||LS mean difference|-51.87|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-52.81|-50.94|||MMRM|||Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.94|-52.81|<0.001
91701874|NCT05238025|183298619|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if both primary outcomes are met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|48.8|||||TWO_SIDED|95.0|25.8|64.7|||||Not formally tested, since the first primary outcome was not met|||64.7|25.8|
91701875|NCT02419612|183298641|SUPERIORITY||Least Squares (LS) Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.57|-0.18|||Mixed Models Analysis|Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.||||-0.18|-0.57|<0.001
91701876|NCT02419612|183298642|SUPERIORITY||LS Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.||||-3.28|-4.84|<0.001
91701877|NCT02419612|183298643|SUPERIORITY||Odds Ratio (OR)|1.5||||0.044||95.0|1.01|2.29|||Regression, Logistic|Adjusted for baseline HbA1c value||||2.29|1.01|0.044
91701878|NCT02419612|183298644|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|1.35||0.007|TWO_SIDED|95.0|-6.3|-1.0|||Mixed Models Analysis|Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction||||-1.0|-6.3|0.007
91701879|NCT02419612|183298645|SUPERIORITY||Hazard Ratio (HR)|0.15||||0.002|TWO_SIDED|95.0|0.04|0.5||This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.|Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.50|0.04|0.002
91701880|NCT02419612|183298646|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.68|0.39|<0.001
91701881|NCT02419612|183298647|SUPERIORITY||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.54||0.006|TWO_SIDED|95.0|1.23|3.42|||Regression, Logistic|Adjusted for baseline HbA1c value.||||3.42|1.23|0.006
91701882|NCT02419612|183298648|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||||0.68|0.39|<0.001
91701883|NCT00191282|183298698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.866||95.0|||||Log Rank|||To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: \>=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of \>=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.||||0.866
91732467|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3269|STANDARD_ERROR_OF_MEAN|0.13362||0.02|TWO_SIDED|95.0|-0.5985|-0.0554|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0554|-0.5985|0.020
91701884|NCT00191282|183298699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.715||95.0|||||Log Rank|||||||0.715
91701885|NCT00191282|183298700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.914||95.0|||||Log Rank|||||||0.914
91701886|NCT00191282|183298701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.706||95.0|||||Log Rank|||||||0.706
91701887|NCT00191282|183298702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.982||95.0|||||Log Rank|||||||0.982
91701888|NCT00191282|183298703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.816||95.0|||||Log Rank|||||||0.816
91701889|NCT00191282|183298704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.948||95.0|||||Log Rank|||||||0.948
91701890|NCT00191282|183298705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.581||95.0|||||Log Rank|||||||0.581
91701891|NCT00191282|183298706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.647||95.0|||||Log Rank|||||||0.647
91701892|NCT00191282|183298707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.525||95.0|||||Log Rank|||||||0.525
91701893|NCT00191282|183298708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8||95.0|||||Log Rank|||||||0.800
91701894|NCT00191282|183298709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.662||95.0|||||Log Rank|||||||0.662
91701895|NCT00191282|183298710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.863||95.0|||||Log Rank|||||||0.863
91701896|NCT00191282|183298711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.471||95.0|||||Log Rank|||||||0.471
91701897|NCT00191282|183298712|SUPERIORITY_OR_OTHER|||||||0.7168||95.0|||||Chi-squared|||||||0.7168
91701898|NCT00191282|183298714|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Chi-squared|||||||0.0860
91701899|NCT00191282|183298716|SUPERIORITY_OR_OTHER|||||||0.1424||95.0|||||Chi-squared|||||||0.1424
91701900|NCT00191282|183298719|SUPERIORITY_OR_OTHER|||||||0.1957||95.0|||||Chi-squared|||||||0.1957
91701901|NCT00191282|183298721|SUPERIORITY_OR_OTHER|||||||0.2434||95.0|||||Chi-squared|||||||0.2434
91701902|NCT00191282|183298723|SUPERIORITY_OR_OTHER|||||||0.2617||95.0|||||Chi-squared|||||||0.2617
91701903|NCT02921750|183298760|NON_INFERIORITY|In this non-inferiority study the primary efficacy analysis included constructing a two sided 95% confidence interval, using Fisher's non-parametric permutation test, for between-treatment differences (Exufiber - Aquacel Extra) in the mean percentage area change from baseline to 6 weeks. This means that if the lower limit of this confidence interval was found to be greater than 12%, non-inferiority will be established.|Mean Difference (Final Values)|-29.4||||0.093|TWO_SIDED|95.0|-63.5|3.2|||Fisher Exact|||||3.2|-63.5|0.093
91701904|NCT04676412|183298768|OTHER|Percent difference and 95% CI were calculated using Miettinen and Nurminen method with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Difference in percentage|-8.4||||0.79262|TWO_SIDED|95.0|-27.4|11.9|||Stratified Miettinen and Nurminen|One-sided p-value for testing. H0: difference in percentage =0 versus H1: difference in percentage \> 0||||11.9|-27.4|0.79262
91701905|NCT04676412|183298771|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-0.25||||0.9519|TWO_SIDED|95.0|-8.59|8.09|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||8.09|-8.59|0.9519
91701906|NCT04676412|183298772|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|8.81||||0.0628|TWO_SIDED|95.0|-0.49|18.11|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||18.11|-0.49|0.0628
91494116|NCT01638546|182859892|OTHER||||||||||||||||||The study will be performed as a double-blind, placebo controlled, randomized Phase II in patients with relapsed sensitive or refractory SCLC. Eligible patients will be randomized 1:1 to one of two treatment arms: ABT-888 and temozolomide as the investigational arm, versus placebo and temozolomide as the control arm. The randomization will be stratified by center and by type or relapse (sensitive vs. refractory). The primary objective is to compare the two treatment regimens with respect to efficacy, expressed as Progression Free Survival (PFS) at 4 months post-randomization. PFS will be calculated as proportion of patients alive and without evidence of disease at 4 months after randomization.|||
91494117|NCT00540514|182859907|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.313||||0.005|TWO_SIDED|95.1|1.082|1.593||Statistical significance defined as P-value \< 0.049.|Chi-squared||Response rate ratio = PA/PT. A response rate ratio \> 1 favors the albumin-bound paclitaxel/carboplatin arm of the study.|The null hypothesis is that the albumin-bound paclitaxel/carboplatin regimen response rate (PA) is equal to that of the paclitaxel (Taxol)/carboplatin regimen (PT). Superiority of albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin will be established if the lower bound of the 95.1% CI of the response rate ratio is \> 1.0.||1.593|1.082|0.005
91494118|NCT00540514|182859908|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.902||||0.214|TWO_SIDED|95.1|0.767|1.06||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.060|0.767|0.214
91732468|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0845|STANDARD_ERROR_OF_MEAN|0.14418||0.562|TWO_SIDED|95.0|-0.3775|0.2085|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2085|-0.3775|0.562
91732469|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1727|STANDARD_ERROR_OF_MEAN|0.13695||0.216|TWO_SIDED|95.0|-0.451|0.1056|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1056|-0.4510|0.216
91701907|NCT04676412|183298773|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|3.59||||0.3298|TWO_SIDED|95.0|-3.7|10.87|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.87|-3.70|0.3298
91701908|NCT04676412|183298774|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-0.28||||0.9594|TWO_SIDED|95.0|-11.32|10.75|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.75|-11.32|0.9594
91732470|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0084|STANDARD_ERROR_OF_MEAN|0.17609||0.962|TWO_SIDED|95.0|-0.3663|0.3495|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3495|-0.3663|0.962
91732471|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0357|STANDARD_ERROR_OF_MEAN|0.19001||0.852|TWO_SIDED|95.0|-0.4218|0.3505|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3505|-0.4218|0.852
91732472|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2154|STANDARD_ERROR_OF_MEAN|0.18048||0.241|TWO_SIDED|95.0|-0.5822|0.1514|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1514|-0.5822|0.241
91494119|NCT00540514|182859909|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.922||||0.271|TWO_SIDED|95.1|0.797|1.066||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.066|0.797|0.271
91732473|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.17766||0.443|TWO_SIDED|95.0|-0.4991|0.223|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2230|-0.4991|0.443
91732474|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2037|STANDARD_ERROR_OF_MEAN|0.1917||0.295|TWO_SIDED|95.0|-0.5933|0.1859|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1859|-0.5933|0.295
91732475|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0602|STANDARD_ERROR_OF_MEAN|0.18209||0.743|TWO_SIDED|95.0|-0.4303|0.3098|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3098|-0.4303|0.743
91732476|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1774|STANDARD_ERROR_OF_MEAN|0.16068||0.277||95.0|-0.504|0.1491|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1491|-0.5040|0.277
91528793|NCT00384059|182933509|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.8|1.26||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.26|0.80|
91528794|NCT00384059|182933509|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.23||||||For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated||1.23|0.81|
91732477|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.17338||0.758|TWO_SIDED|95.0|-0.4062|0.2985|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2985|-0.4062|0.758
91732478|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4377|STANDARD_ERROR_OF_MEAN|0.16468||0.012|TWO_SIDED|95.0|-0.7724|-0.1031|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.1031|-0.7724|0.012
91494120|NCT00540514|182859910|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.074||||0.239|TWO_SIDED|95.0|0.953|1.21|||Chi-squared|||||1.210|0.953|0.239
91528795|NCT00384059|182933510|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.83|1.53||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.53|0.83|
91528796|NCT00384059|182933515|SUPERIORITY_OR_OTHER||Ration|0.85||||||95.0|0.48|1.49||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.49|0.48|
91701909|NCT04676412|183298775|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-5.53||||0.162|TWO_SIDED|95.0|-13.37|2.31|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||2.31|-13.37|0.1620
91701910|NCT04676412|183298776|OTHER|HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.03||||0.9419|TWO_SIDED|95.0|0.47|2.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.26|0.47|0.9419
91701911|NCT04676412|183298777|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.01||||0.9789|TWO_SIDED|95.0|0.43|2.38|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.38|0.43|0.9789
91701912|NCT04676412|183298778|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.08||||0.8856|TWO_SIDED|95.0|0.36|3.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.28|0.36|0.8856
91701913|NCT04676412|183298779|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.55||||0.3264|TWO_SIDED|95.0|0.64|3.75|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.75|0.64|0.3264
91701914|NCT04676412|183298780|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.46|0.70|0.4068
91494121|NCT00540514|182859911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.901||||0.551|TWO_SIDED|95.0|0.652|1.244||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma or Non squamous cell carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.244|0.652|0.551
91494122|NCT00540514|182859914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.302||95.0|||||Univariate Cox regression|||SPARC correlation with overall survival for the overall SPARC population.||||0.302
91528797|NCT00381641|182933521|SUPERIORITY|"Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.~Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative."|||||<|0.1||||||"For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.~For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed."|Simon, two-stage design|||Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.||||<0.10
91528798|NCT00802737|182933551|SUPERIORITY_OR_OTHER||proportion of responders|0.24|||||TWO_SIDED|95.0|0.07|0.5|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.50|0.07|
91528799|NCT00802737|182933551|SUPERIORITY_OR_OTHER||proportion of responders|0.18|||||TWO_SIDED|95.0|0.02|0.52|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.52|0.02|
91732479|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1037|STANDARD_ERROR_OF_MEAN|0.14849||0.49|TWO_SIDED|95.0|-0.4055|0.1981|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1981|-0.4055|0.490
91732480|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1007|STANDARD_ERROR_OF_MEAN|0.16023||0.534|TWO_SIDED|95.0|-0.4263|0.2249|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2249|-0.4263|0.534
91732481|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.15219||0.169|TWO_SIDED|95.0|-0.5233|0.0953|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0953|-0.5233|0.169
91732482|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2641|STANDARD_ERROR_OF_MEAN|0.14118||0.07|TWO_SIDED|95.0|-0.551|0.0228|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0228|-0.5510|0.070
91494123|NCT00540514|182859915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||A nonsignificant interaction P-value (ie, p-value ≥ 0.100) indicates the treatment regimen effect was consistent within a prognostic factor.|Regression, Logistic|Logistic regression model with effects for treatment regimen, prognostic factor (histology), and treatment regimen by prognostic factor interaction.||||||0.036
91732483|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0854|STANDARD_ERROR_OF_MEAN|0.15234||0.579|TWO_SIDED|95.0|-0.395|0.2242|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2242|-0.3950|0.579
91528800|NCT00802737|182933551|SUPERIORITY_OR_OTHER||proportion of responders|1.0|||||TWO_SIDED|95.0|0.03|1.0|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||1.00|0.03|
91528801|NCT00445601|182933575|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.9|||Log Rank|||||0.90|0.48|0.01
91528802|NCT00445601|182933576|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.23|TWO_SIDED|95.0|0.18|1.49|||Log Rank|||||1.49|0.18|0.23
91528803|NCT00619476|182933579|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.81||||0.013|TWO_SIDED|95.0|-1.4|-0.23||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.23|-1.40|0.013
91528804|NCT00619476|182933579|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.7||||0.029|TWO_SIDED|95.0|-1.33|-0.07||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.07|-1.33|0.029
91732484|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2446|STANDARD_ERROR_OF_MEAN|0.1447||0.1|TWO_SIDED|95.0|-0.5387|0.0494|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0494|-0.5387|0.100
91732485|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13533||0.113|TWO_SIDED|95.0|-0.495|0.055|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0550|-0.4950|0.113
91494124|NCT01651195|182859920|SUPERIORITY|We estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.14990 and α=0.05), we needed 467 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.|||||<|0.05|||||||Fisher Exact||||"Result variables were analyzed according to intention to treat (ITT) principle. Missing data was handled by statistic modeling. Data on symptom diaries were calculated as follows: the incidence and duration of individual infection symptoms and respiratory episodes were analyzed between the intervention groups using time to event analysis (cox model for hazard) and duration analysis (gamma regression model). The results are expressed as a hazard ratio (incidence rate ratio) of symptoms and the mean duration of symptoms (days) with 95% confidence intervals or standard deviations. The sums of respiratory and gastrointestinal symptoms were calculated with gamma regression analysis."|||< 0.05
91494125|NCT01651195|182859921|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
91494126|NCT01651195|182859922|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
91494127|NCT01651195|182859923|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
91494128|NCT04617509|182859956|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric means|1.4514|||||TWO_SIDED|90.0|1.111|1.4514||||||Relative bioavailability (A versus B)||1.4514|1.1110|
91701915|NCT04676412|183298781|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|7.81||||0.002|TWO_SIDED|95.0|1.71|35.62|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||35.62|1.71|0.0020
91494129|NCT04617509|182859956|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.5497|||||TWO_SIDED|90.0|0.3977|0.7597||||||Relative bioavailability (A FED versus A FASTED)||0.7597|0.3977|
91494130|NCT04617509|182859957|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.3441|||||TWO_SIDED|90.0|1.0953|1.6495||||||Relative bioavailability (A versus B)||1.6495|1.0953|
91494131|NCT04617509|182859957|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7327|||||TWO_SIDED|90.0|0.591|0.9083||||||Relative bioavailability (A FED versus A FASTED)||0.9083|0.5910|
91494132|NCT04617509|182859958|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.371|||||TWO_SIDED|90.0|1.112|1.6904||||||Relative bioavailability (A versus B)||1.6904|1.1120|
91494133|NCT04617509|182859958|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7083|||||TWO_SIDED|90.0|0.5728|0.8759||||||Relative bioavailability (A FED versus A FASTED)||0.8759|0.5728|
91494134|NCT00618072|182859971|SUPERIORITY_OR_OTHER|||||||0.181|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.181
91701916|NCT04676412|183298782|OTHER|Hazard ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.18||||0.71084|TWO_SIDED|95.0|0.61|2.25|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||||2.25|0.61|0.71084
91494135|NCT00618072|182859971|SUPERIORITY_OR_OTHER|||||||0.026|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.026
91494136|NCT00618072|182859971|SUPERIORITY_OR_OTHER|||||||0.063|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.063
91494137|NCT00618072|182859972|SUPERIORITY_OR_OTHER|||||||0.049|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.049
91494138|NCT00618072|182859972|SUPERIORITY_OR_OTHER|||||||0.002|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.002
91494139|NCT00618072|182859972|SUPERIORITY_OR_OTHER|||||||0.032|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.032
91494140|NCT00618072|182859973|SUPERIORITY_OR_OTHER|||||||0.142|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.142
91494141|NCT00618072|182859973|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
91705529|NCT04494425|183305651|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Log Rank|The analysis was performed using the stratified log-rank test.|HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.|||0.75|0.52|<0.0001
91705530|NCT02242019|183305689|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91705531|NCT02242019|183305690|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91701917|NCT04676412|183298783|OTHER||Hazard Ratio (HR)|1.53||||0.8197|TWO_SIDED|95.0|0.61|3.87|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||HR and 95% CIs were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).||3.87|0.61|0.81970
91701918|NCT04765722|183298794|SUPERIORITY||% change relative to placebo|18.0||||0.99|TWO_SIDED|95.0|-46.4|160.1||The model included treatment group, week, the interaction between treatment group and week, and baseline log-transformed 24-hour cough frequency as fixed effects.|Generalized estimating equations|Hypothesis tests were two-sided, a p\<0.05 indicated statistical significance. We made no adjustments for multiple comparisons across outcomes.||The primary outcome was the change from baseline in log-transformed 24-hour cough frequency (coughs/hour) at week 14.||160.1|-46.4|0.99
91701919|NCT01458951|183298810|SUPERIORITY_OR_OTHER||Percentage difference|13.0||||0.0005|TWO_SIDED|95.0|8.1|17.9|||CMH Chi-square Test|||P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).||17.9|8.1|0.0005
91701920|NCT01458951|183298811|SUPERIORITY_OR_OTHER||Percentage difference|16.8||||0.0002|TWO_SIDED|95.0|9.5|24.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|9.5|0.0002
91701921|NCT01458951|183298812|SUPERIORITY_OR_OTHER||Percentage difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.0|16.8|<0.0001
91701922|NCT01458951|183298813|SUPERIORITY_OR_OTHER||Percentage difference|5.2||||0.0425|TWO_SIDED|95.0|1.8|8.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.6|1.8|0.0425
91701923|NCT01458951|183298814|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0004|TWO_SIDED|95.0|8.3|18.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.1|8.3|0.0004
91701924|NCT01458951|183298815|SUPERIORITY_OR_OTHER||Percentage difference|8.0||||0.009|TWO_SIDED|95.0|3.9|12.2|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||12.2|3.9|0.0090
91701925|NCT01458951|183298816|SUPERIORITY_OR_OTHER||Percentage difference|3.3||||0.1408|TWO_SIDED|95.0|0.1|6.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||6.6|0.1|0.1408
91701926|NCT01458951|183298818|SUPERIORITY_OR_OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.6|-1.4|<0.0001
91701927|NCT01458951|183298818|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.7|-1.6|<0.0001
91701928|NCT01458951|183298818|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Models Analysis|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.9|-1.7|<0.0001
91732486|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0527|STANDARD_ERROR_OF_MEAN|0.14603||0.72|TWO_SIDED|95.0|-0.3495|0.244|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2440|-0.3495|0.720
91494142|NCT00618072|182859973|SUPERIORITY_OR_OTHER|||||||0.013|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.013
91701929|NCT01458951|183298819|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||ANCOVA|||The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.0|-2.2|<0.0001
91701930|NCT00585013|183298820|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This p value applies to all time points for all variables.|Wilcoxon (Mann-Whitney)|||||||>0.05
91494143|NCT00618072|182859974|SUPERIORITY_OR_OTHER|||||||0.052|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.052
91701931|NCT00585013|183298821|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies for measurements at preoperative and 0 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
91732487|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183|STANDARD_ERROR_OF_MEAN|0.1387||0.196|TWO_SIDED|95.0|-0.4649|0.0989|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0989|-0.4649|0.196
91732488|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2051|STANDARD_ERROR_OF_MEAN|0.20032||0.313|TWO_SIDED|95.0|-0.6122|0.202|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2020|-0.6122|0.313
91732489|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0253|STANDARD_ERROR_OF_MEAN|0.21616||0.908|TWO_SIDED|95.0|-0.414|0.4646|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4646|-0.4140|0.908
91732490|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3042|STANDARD_ERROR_OF_MEAN|0.20531||0.148|TWO_SIDED|95.0|-0.7214|0.1131|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1131|-0.7214|0.148
91732491|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3409|STANDARD_ERROR_OF_MEAN|0.17997||0.067|TWO_SIDED|95.0|-0.7066|0.0249|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0249|-0.7066|0.067
91732492|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0652|STANDARD_ERROR_OF_MEAN|0.19419||0.739|TWO_SIDED|95.0|-0.4599|0.3294|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3294|-0.4599|0.739
91732493|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4163|STANDARD_ERROR_OF_MEAN|0.18445||0.031|TWO_SIDED|95.0|-0.7912|-0.0415|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0415|-0.7912|0.031
91732494|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2032|STANDARD_ERROR_OF_MEAN|0.14369||0.166|TWO_SIDED|95.0|-0.4952|0.0888|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0888|-0.4952|0.166
91732495|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0932|STANDARD_ERROR_OF_MEAN|0.15504||0.552|TWO_SIDED|95.0|-0.2219|0.4083|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4083|-0.2219|0.552
91732496|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1648|STANDARD_ERROR_OF_MEAN|0.14727||0.271|TWO_SIDED|95.0|-0.4641|0.1345|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1345|-0.4641|0.271
91732497|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2516|STANDARD_ERROR_OF_MEAN|0.16169||0.129|TWO_SIDED|95.0|-0.5802|0.077|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0770|-0.5802|0.129
91732498|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1279|STANDARD_ERROR_OF_MEAN|0.17447||0.468|TWO_SIDED|95.0|-0.2266|0.4825|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4825|-0.2266|0.468
91732499|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2033|STANDARD_ERROR_OF_MEAN|0.16572||0.228|TWO_SIDED|95.0|-0.5401|0.1334|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1334|-0.5401|0.228
91732500|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13268||0.141|TWO_SIDED|95.0|-0.4696|0.0696|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0696|-0.4696|0.141
91732501|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0065|STANDARD_ERROR_OF_MEAN|0.14317||0.964|TWO_SIDED|95.0|-0.2975|0.2844|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2844|-0.2975|0.964
91701932|NCT00585013|183298821|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to measurements at time points 12 h, 24 h, and 48 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
91701933|NCT00585013|183298822|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies to measurements at preoperative, 0 h, and 48 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
91701934|NCT00585013|183298822|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to time points at 12 h and 24 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
91701935|NCT00585013|183298823|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Applies to all time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
91701936|NCT03309696|183298828|EQUIVALENCE|A p value of \<.0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.59||||0.055|TWO_SIDED|||||The p value is not adjusted because it was a planned contrast.|Mixed Models Analysis||Active tDCS - sham tDCS.|Examines the effect of tDCS preconditioning on P100 amplitudes. The effect size for this comparison was .33 (Cohen's).||||.055
91732502|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1935|STANDARD_ERROR_OF_MEAN|0.13599||0.164|TWO_SIDED|95.0|-0.4699|0.0828|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0828|-0.4699|0.164
91732503|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1446|STANDARD_ERROR_OF_MEAN|0.13315||0.285|TWO_SIDED|95.0|-0.4152|0.126|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1260|-0.4152|0.285
91732504|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0176|STANDARD_ERROR_OF_MEAN|0.14368||0.903|TWO_SIDED|95.0|-0.3096|0.2744|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2744|-0.3096|0.903
91732505|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1615|STANDARD_ERROR_OF_MEAN|0.13647||0.245|TWO_SIDED|95.0|-0.4388|0.1159|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1159|-0.4388|0.245
91732506|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3659|STANDARD_ERROR_OF_MEAN|0.45708||0.429|TWO_SIDED|95.0|-0.563|1.2948|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.2948|-0.5630|0.429
91732507|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0395|STANDARD_ERROR_OF_MEAN|0.49321||0.937|TWO_SIDED|95.0|-0.9628|1.0419|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.0419|-0.9628|0.937
91732508|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7902|STANDARD_ERROR_OF_MEAN|0.46847||0.101|TWO_SIDED|95.0|-0.1618|1.7423|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.7423|-0.1618|0.101
91732509|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4404|STANDARD_ERROR_OF_MEAN|0.43756||0.321|TWO_SIDED|95.0|-1.3296|0.4488|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4488|-1.3296|0.321
91732510|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4685|STANDARD_ERROR_OF_MEAN|0.47214||0.328|TWO_SIDED|95.0|-1.428|0.491|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4910|-1.4280|0.328
91494144|NCT00618072|182859974|SUPERIORITY_OR_OTHER|||||||0.143|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.143
91701937|NCT03309696|183298828|EQUIVALENCE|A p value of \<.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|0.36||||0.0418|TWO_SIDED|||||This p value is not adjusted for multiple comparisons because it was a planned contrast.|Mixed Models Analysis||Sham tDCS - Sham tDCS and Active rTMS|Examines the effect of rTMS on the P100 amplitude. The calculated effect size is .35 (Cohen's).||||0.0418
91701938|NCT03309696|183298828|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.19||||0.4|TWO_SIDED|||||The p value is not adjusted as this was a planned contrast.|Mixed Models Analysis||Effect of tDCS preconditioning on active rTMS: active tDCS preconditioning of active rTMS - sham tDCS preconditioning of active rTMS.|Examines the additive effect of tDCS preconditioning on the P100 amplitude after rTMS. The effect size for this comparison was 0.14.||||0.40
91701939|NCT03309696|183298828|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.48||||0.086|TWO_SIDED|||||The p value was not adjusted for this planned contrast.|Mixed Models Analysis||Active tDCS and Active rTMS - Sham tDCS and Sham rTMS.|Examines the combined effect of tDCS and rTMS on the P100 amplitude. The effect size for this comparison was .29 (Cohen's).||||.086
91701940|NCT05070468|183298848|SUPERIORITY|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
91701941|NCT05070468|183298849|SUPERIORITY|||||||0.483|||||||Wilcoxon (Mann-Whitney)|||||||0.483
91701942|NCT05070468|183298850|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
91732511|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.44846||0.356|TWO_SIDED|95.0|-0.4914|1.3314|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.3314|-0.4914|0.356
91732512|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2254|STANDARD_ERROR_OF_MEAN|0.1679||0.188|TWO_SIDED|95.0|-0.5666|0.1158|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1158|-0.5666|0.188
91732513|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0232|STANDARD_ERROR_OF_MEAN|0.18117||0.899|TWO_SIDED|95.0|-0.3914|0.3449|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3449|-0.3914|0.899
91701943|NCT00577005|183298851|SUPERIORITY_OR_OTHER||Slope|-0.05425|STANDARD_ERROR_OF_MEAN|0.03211||0.09|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly cocaine urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z=-1.68950 p = 0.09112|||||0.09
91701944|NCT00577005|183298852|SUPERIORITY_OR_OTHER||Slope|0.0257|STANDARD_ERROR_OF_MEAN|0.04369||0.55|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly opioid urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z= 0.58823 p = 0.55638|||||0.55
91701945|NCT00577005|183298853|SUPERIORITY_OR_OTHER|||||||0.67||||||p-value \<0.05 considered statistically significant|Log Rank|Chi-Square 0.175. df = 1, p=0.676||||||0.67
91701946|NCT00577005|183298854|SUPERIORITY_OR_OTHER||Slope|-0.1557||||0.11|TWO_SIDED|||||Significant p-value \< 0.05|Mixed Models Analysis||Interaction of time x group: Z = -1.5671, p = 0.11708|||||0.11
91701947|NCT02453282|183298875|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.036|TWO_SIDED|97.54|0.564|1.019||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.019|0.564|0.036
91701948|NCT02453282|183298875|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.202|TWO_SIDED|98.77|0.611|1.173||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.173|0.611|0.202
91701949|NCT02453282|183298876|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.705|TWO_SIDED|99.5|0.722|1.534||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.534|0.722|0.705
91701950|NCT02453282|183298877|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.523|TWO_SIDED|95.0|0.836|1.421||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.421|0.836|0.523
91732514|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2534|STANDARD_ERROR_OF_MEAN|0.17208||0.15|TWO_SIDED|95.0|-0.6032|0.0963|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0963|-0.6032|0.150
91732515|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2821|STANDARD_ERROR_OF_MEAN|0.19038||0.148|TWO_SIDED|95.0|-0.669|0.1048|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1048|-0.6690|0.148
91759183|NCT04038567|183411375|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-6.09|6.3||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||6.30|-6.09|
91759184|NCT04038567|183411382|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.26|-0.13||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.13|-5.26|
91701951|NCT02453282|183298878|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.194|TWO_SIDED|95.0|0.725|1.067||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.067|0.725|0.194
91701952|NCT02453282|183298878|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.952|TWO_SIDED|95.0|0.834|1.213||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.213|0.834|0.952
91701953|NCT02453282|183298878|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.218|TWO_SIDED|95.0|0.931|1.371||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.371|0.931|0.218
91701954|NCT02453282|183298879|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.602|TWO_SIDED|95.0|0.812|1.128||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.128|0.812|0.602
91705532|NCT05206734|183305708|OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|1.12|1.46|||||HR was calculated using a Cox Proportional Hazard model adjusted for age,sex,socioeconomic status, ethnicity and common childhood conditions. Reflects a comparison of the incidence rates between participants diagnosed with IBD and those without IBD.|||1.46|1.12|
91705533|NCT05206734|183305709|OTHER||Risk Ratio (RR)|1.82|||||TWO_SIDED|95.0|1.33|2.52|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.52|1.33|
91705534|NCT05206734|183305710|OTHER||Hazard Ratio (HR)|1.63|||||TWO_SIDED|95.0|1.02|2.62|||||HR calculated using Cox regression models adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.62|1.02|
91705535|NCT05206734|183305711|OTHER||Risk Ratio (RR)|2.78|||||TWO_SIDED|95.0|1.76|4.43|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||4.43|1.76|
91705536|NCT05206734|183305713|OTHER||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||1.58|1.12|
91705537|NCT05206734|183305714|OTHER||Risk Ratio (RR)|1.87|||||TWO_SIDED|95.0|1.29|2.75|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.75|1.29|
91705538|NCT00762034|183305715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.94896|TWO_SIDED|95.0|0.86|1.16|||Log Rank|||||1.16|0.86|0.94896
91705539|NCT00762034|183305716|SUPERIORITY_OR_OTHER|||||||0.72997||95.0|||||Fisher Exact|||||||0.72997
91705540|NCT00762034|183305717|SUPERIORITY_OR_OTHER|||||||0.20892|||||||Fisher Exact|||||||0.20892
91705541|NCT00762034|183305718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.01206|TWO_SIDED|95.0|0.71|0.96|||Log Rank|||||0.96|0.71|0.01206
91705542|NCT00762034|183305719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.006|TWO_SIDED|95.0|0.67|0.94|||Log Rank|||||0.94|0.67|0.006
91705543|NCT00762034|183305724|SUPERIORITY_OR_OTHER|||||||0.667||95.0||||Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.667
91705544|NCT00762034|183305725|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.815
91705545|NCT00762034|183305725|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.978
91705546|NCT00762034|183305726|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91705547|NCT00762034|183305726|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91705548|NCT00762034|183305740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.338|0.681||p-value was not adjusted for multiple comparisons.|Regression, Cox|||||0.681|0.338|<0.001
91705549|NCT00762034|183305741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.673|TWO_SIDED|95.0|0.654|1.316||p-value is for TS Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.316|0.654|0.673
91705550|NCT00762034|183305741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.521||||0.287|TWO_SIDED|95.0|0.157|1.729||p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.729|0.157|0.287
91705551|NCT00762034|183305741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.759||||0.2|TWO_SIDED|95.0|0.498|1.157||p-value is for TS Nucleus Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.157|0.498|0.2
91705552|NCT00762034|183305741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.915|TWO_SIDED|95.0|0.54|1.738||p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.738|0.540|0.915
91705553|NCT00762034|183305742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.891|TWO_SIDED|95.0|0.622|1.511||p-value for FR-α Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.511|0.622|0.891
91705554|NCT00762034|183305742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.06|TWO_SIDED|95.0|0.342|1.023||p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.023|0.342|0.060
91705555|NCT00762034|183305742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.905|TWO_SIDED|95.0|0.49|1.88||p-value for FR-α Membrane Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.880|0.490|0.905
91732516|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.048|STANDARD_ERROR_OF_MEAN|0.20543||0.817|TWO_SIDED|95.0|-0.4655|0.3695|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3695|-0.4655|0.817
91732517|NCT01892189|183359719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3395|STANDARD_ERROR_OF_MEAN|0.19513||0.091|TWO_SIDED|95.0|-0.7361|0.057|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0570|-0.7361|0.091
91732518|NCT01052779|183359754|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.1||||0.515|TWO_SIDED|95.0|-0.21|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.21|0.515
91732519|NCT01052779|183359754|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.09||||0.587|TWO_SIDED|95.0|-0.23|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.23|0.587
91732520|NCT03524157|183359776|NON_INFERIORITY|it will be considered non-inferior if there are no differences greater than 20%.||||||0.273|||||||Kruskal-Wallis|||||||0.273
91732521|NCT03524157|183359777|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.788|||||||Kruskal-Wallis|||||||0.788
91732522|NCT03524157|183359779|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91732523|NCT03524157|183359780|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.008|||||||Kruskal-Wallis|||||||0.008
91732524|NCT03524157|183359781|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91494145|NCT00618072|182859974|SUPERIORITY_OR_OTHER|||||||0.005|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.005
91732525|NCT03524157|183359783|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91494146|NCT00618072|182859975|SUPERIORITY_OR_OTHER|||||||0.265|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.265
91494147|NCT00618072|182859975|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.001
91494148|NCT00618072|182859975|SUPERIORITY_OR_OTHER|||||||0.389|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.389
91732526|NCT03524157|183359784|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91732527|NCT03524157|183359785|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared|||||||>0.05
91732528|NCT02743962|183359786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|2.12|||TWO_SIDED|||||||||The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.||||
91732529|NCT02743962|183359786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.25|STANDARD_DEVIATION|2.67|||TWO_SIDED|||||||||There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group's score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).||||
91732530|NCT04805593|183359794|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 50%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
91732531|NCT04805593|183359795|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 75%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
91732532|NCT04330859|183359839|SUPERIORITY||Agresti-Caffo|95.0||||0.0543|TWO_SIDED|||||58.8 ± 7.2 (intervention) and 57.2 ± 11.2 (control; p = 0.0543)|t-test, 1 sided|||||||0.0543
91732533|NCT03312543|183359871|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.18|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.09|0.26|||t-test, 2 sided|||||0.26|0.09|<0.001
91732534|NCT03312543|183359871|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.341|<|0.001|TWO_SIDED|95.0|0.21|0.39|||t-test, 2 sided|||||0.39|0.21|<0.001
91732535|NCT03312543|183359871|OTHER|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.025|TWO_SIDED|95.0|0.02|0.25|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.25|0.02|0.025
91732536|NCT03312543|183359872|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.349|<|0.001|TWO_SIDED|95.0|0.11|0.29|||t-test, 2 sided|||||0.29|0.11|<0.001
91732537|NCT03312543|183359872|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.13|0.31|||t-test, 2 sided|||||0.31|0.13|<0.001
91494149|NCT00618072|182859976|SUPERIORITY_OR_OTHER|||||||0.025|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.025
91732538|NCT03312543|183359872|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.54|TWO_SIDED|95.0|-0.09|0.16|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.16|-0.09|0.540
91732539|NCT03312543|183359873|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.532||0.627|TWO_SIDED|95.0|-0.17|0.1|||t-test, 2 sided|||||0.10|-0.17|0.627
91732540|NCT03312543|183359873|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.5||0.002|TWO_SIDED|95.0|0.08|0.34|||t-test, 2 sided|||||0.34|0.08|0.002
91732541|NCT03312543|183359873|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.092||0.009|TWO_SIDED|95.0|0.06|0.42|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.42|0.06|0.009
91732542|NCT03312543|183359874|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.36|STANDARD_DEVIATION|0.465|<|0.001|TWO_SIDED|95.0|0.23|0.48|||t-test, 2 sided|||||0.48|0.23|<0.001
91732543|NCT03312543|183359874|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.47|STANDARD_DEVIATION|0.578|<|0.001|TWO_SIDED|95.0|0.32|0.63|||t-test, 2 sided|||||0.63|0.32|<0.001
91494150|NCT00618072|182859976|SUPERIORITY_OR_OTHER|||||||0.162|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.162
91494151|NCT00618072|182859976|SUPERIORITY_OR_OTHER|||||||0.562|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.562
91494152|NCT00618072|182859977|SUPERIORITY_OR_OTHER|||||||0.016|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.016
91494153|NCT00618072|182859977|SUPERIORITY_OR_OTHER|||||||0.03|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.03
91494154|NCT00618072|182859977|SUPERIORITY_OR_OTHER|||||||0.15|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.150
91701955|NCT02453282|183298879|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.43|TWO_SIDED|95.0|0.794|1.103||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.103|0.794|0.430
91701956|NCT02453282|183298879|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.802|TWO_SIDED|95.0|0.828|1.157||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.157|0.828|0.802
91701957|NCT02453282|183298880|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.324|TWO_SIDED|95.0|0.667|1.143||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.143|0.667|0.324
91701958|NCT02453282|183298880|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.207|TWO_SIDED|95.0|0.911|1.541||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.541|0.911|0.207
91701959|NCT02453282|183298881|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.383|TWO_SIDED|95.0|0.894|1.339||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.339|0.894|0.383
91701960|NCT02453282|183298881|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.001|TWO_SIDED|95.0|1.136|1.678||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.678|1.136|0.001
91701961|NCT02453282|183298881|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.138|TWO_SIDED|95.0|0.954|1.403||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.403|0.954|0.138
91701962|NCT02453282|183298882|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.015|TWO_SIDED|95.0|1.043|1.475||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.475|1.043|0.015
91705556|NCT00762034|183305742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859||||0.455|TWO_SIDED|95.0|0.575|1.281||p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.281|0.575|0.455
91705557|NCT00734656|183305743|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||null hypothesis - dutasteride does not affect blood alcohol following standardized dose of alcohol (0.8 gr/kg)||||0.28
91494155|NCT00618072|182859978|SUPERIORITY_OR_OTHER|||||||0.648|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.648
91494156|NCT00618072|182859978|SUPERIORITY_OR_OTHER|||||||0.094|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.094
91705558|NCT00734656|183305744|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the sedative effect of alcohol||||0.010
91705559|NCT00734656|183305745|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the stimulating effect of alcohol||||0.17
91705560|NCT00734656|183305746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||null hypothesis - A single 4 mg dose of dutasteride does not reduce serum 3a-androstanediol glucuronide levels||||<0.001
91705561|NCT03214679|183305748|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
91705562|NCT01601067|183305753|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.002
91705563|NCT01601067|183305754|SUPERIORITY|||||||0.91||||||heavy drinking days|Mixed Models Analysis|||||||.91
91705564|NCT02412878|183305769|SUPERIORITY||Odds Ratio (OR)|2.485|||<|0.0001|TWO_SIDED|95.0|1.716|3.598||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Cochran-Mantel-Haenszel|One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.|||3.598|1.716|< 0.0001
91701963|NCT02453282|183298882|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.01|TWO_SIDED|95.0|1.054|1.485||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.485|1.054|0.010
91701964|NCT02453282|183298882|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.984|TWO_SIDED|95.0|0.845|1.179||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.179|0.845|0.984
91494157|NCT00618072|182859978|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
91701965|NCT02453282|183298883|SUPERIORITY||Odds Ratio (OR)|0.91||||0.698|TWO_SIDED|95.0|0.582|1.437||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.437|0.582|0.698
91701966|NCT02453282|183298883|SUPERIORITY||Odds Ratio (OR)|0.87||||0.534|TWO_SIDED|95.0|0.549|1.363||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.363|0.549|0.534
91701967|NCT02453282|183298883|SUPERIORITY||Odds Ratio (OR)|0.95||||0.82|TWO_SIDED|95.0|0.601|1.496||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.496|0.601|0.820
91701968|NCT02453282|183298884|SUPERIORITY||Odds Ratio (OR)|0.69||||0.05|TWO_SIDED|95.0|0.48|1.0||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.000|0.480|0.050
91701969|NCT02453282|183298884|SUPERIORITY||Odds Ratio (OR)|0.67||||0.029|TWO_SIDED|95.0|0.464|0.959||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.959|0.464|0.029
91701970|NCT02453282|183298884|SUPERIORITY||Odds Ratio (OR)|0.97||||0.887|TWO_SIDED|95.0|0.661|1.43||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.430|0.661|0.887
91701971|NCT02453282|183298885|SUPERIORITY||Odds Ratio (OR)|0.65||||0.012|TWO_SIDED|95.0|0.462|0.908||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.908|0.462|0.012
91701972|NCT02453282|183298885|SUPERIORITY||Odds Ratio (OR)|0.76||||0.093|TWO_SIDED|95.0|0.543|1.048||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.048|0.543|0.093
91732544|NCT03312543|183359874|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.094||0.224|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.30|-0.07|0.224
91494158|NCT00618072|182859979|SUPERIORITY_OR_OTHER|||||||0.092|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.092
91494159|NCT00618072|182859979|SUPERIORITY_OR_OTHER|||||||0.73|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.730
91494160|NCT00618072|182859979|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||<0.001
91494161|NCT03143894|182859992|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.47|TWO_SIDED||||||t-test, 2 sided|||||||0.47
91494162|NCT03143894|182859993|SUPERIORITY||Mean Difference (Net)|0.69||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
91494163|NCT03143894|182859994|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
91701973|NCT02453282|183298885|SUPERIORITY||Odds Ratio (OR)|1.16||||0.406|TWO_SIDED|95.0|0.818|1.647||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.647|0.818|0.406
91494164|NCT05048784|182860001|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for Cmax.|Ratio of geometric least squares means|1.009|||||TWO_SIDED|90.0|0.98|1.04|||||The geometric least squares mean ratios and confidence intervals (Cls) were obtained by taking the exponential of the corresponding differences and Cls on the natural-log (In) scale.|||1.040|0.980|
91701974|NCT02453282|183298892|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.03|TWO_SIDED|95.0|0.597|0.975||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.975|0.597|0.030
91701975|NCT02453282|183298892|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.045|TWO_SIDED|95.0|0.606|0.994||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.994|0.606|0.045
91701976|NCT02453282|183298893|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.255|TWO_SIDED|95.0|0.746|1.08||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.080|0.746|0.255
91701977|NCT02453282|183298893|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.534|TWO_SIDED|95.0|0.787|1.132||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.132|0.787|0.534
91701978|NCT02453282|183298894|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.663|TWO_SIDED|95.0|0.824|1.131||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.131|0.824|0.663
91701979|NCT02453282|183298894|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.103|TWO_SIDED|95.0|0.746|1.027||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.027|0.746|0.103
91701980|NCT00985426|183298911|NON_INFERIORITY|Non-inferiority is achieved if the lower limit of the two-sided 95% CI was greater than -10%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3|||||SPR difference = SPR for HEPLISAV-B minus SPR for Engerix-B.|Two-sided 95% confidence intervals (CIs) of the difference in seroprotection rates (SPR) between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
91701981|NCT00985426|183298911|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3||||||Two-sided 95% CIs of the difference in SPR between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
91701982|NCT00985426|183298916|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|12.9|||||TWO_SIDED|95.0|4.4|21.2||||||Two-sided 95% CIs of the difference in SPRs between the HEPLISAV group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||21.2|4.4|
91701983|NCT02327013|183298934|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.9723|TWO_SIDED|95.0|-3.6|3.5|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.||3.5|-3.6|0.9723
91701984|NCT02327013|183298934|SUPERIORITY|The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.9||0.601|TWO_SIDED|95.0|-2.8|4.8|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||||4.8|-2.8|0.6010
91701985|NCT02380859|183298977|SUPERIORITY|||||||0.005|||||||ANOVA|||Group (real, sham) x Time (pre, 1d post) x Stepping Direction (forward, backward) ANOVA||||0.005
91701986|NCT01661933|183298991|SUPERIORITY_OR_OTHER|||||||0.693|TWO_SIDED||||||t-test, 2 sided|||||||0.693
91701987|NCT01661933|183298992|SUPERIORITY_OR_OTHER||||||=|0.837|TWO_SIDED||||||t-test, 2 sided|||||||=0.837
91701988|NCT01661933|183298993|SUPERIORITY_OR_OTHER||||||=|0.99|ONE_SIDED||||||Binomial distribution|||The null hypothesis was that irrespective of hookworm infection, GC-1g would result in a 2-point or more deterioration in the Marsh score. A binomial (yes=deterioration or no=no deterioration) distribution was applied to pre- and post-GC-1g paired biopsies.||||=0.99
91701989|NCT01661933|183298994|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Mixed effects model.|||||||=0.005
91701990|NCT02063178|183299029|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This randomized clinical trial was designed to have 90% power to detect a 4% weight loss percent difference at 12 months between the two study arms.||||<0.001
91701991|NCT02063178|183299030|OTHER|Correlation|||||<|0.0001|||||||Correlation|||The association between weight change percent and attendance was described using Spearman rank correlation.||||<0.0001
91732545|NCT05852340|183359921|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|102.36|||||TWO_SIDED|90.0|95.81|109.35||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||109.35|95.81|
91732546|NCT05852340|183359921|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|97.15|||||TWO_SIDED|90.0|90.94|103.79||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||103.79|90.94|
91732547|NCT05852340|183359921|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|99.65|||||TWO_SIDED|90.0|93.28|106.46||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||106.46|93.28|
91732548|NCT05852340|183359921|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.84|||||TWO_SIDED|90.0|97.3|112.96||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||112.96|97.30|
91732549|NCT05852340|183359922|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.63|||||TWO_SIDED|90.0|83.66|111.62||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||111.62|83.66|
91732550|NCT05852340|183359922|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|84.58|||||TWO_SIDED|90.0|73.23|97.7||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||97.70|73.23|
91732551|NCT05852340|183359922|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|93.91|||||TWO_SIDED|90.0|81.3|108.48||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||108.48|81.30|
91701992|NCT02063178|183299031|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
91701993|NCT02063178|183299032|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
91701994|NCT00001656|183299046|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||.04
91701995|NCT00001656|183299047|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.21
91701996|NCT00001656|183299048|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.35
91701997|NCT00001656|183299049|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.19
91732552|NCT05852340|183359922|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|43.83|||||TWO_SIDED|90.0|37.5|51.23||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||51.23|37.50|
91732553|NCT00071032|183359929|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.84|1.22|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.22|0.84|
91732554|NCT00071032|183359930|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9|||||TWO_SIDED|99.0|-3.3|1.6|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.6|-3.3|
91732555|NCT04197583|183359945|OTHER||Proportion by group|0.984|||||TWO_SIDED|95.0|0.948|0.995|||||For Tria subjects with stone management indication only|||0.995|0.948|
91732556|NCT00375713|183359949|NON_INFERIORITY_OR_EQUIVALENCE|The pre-set threshold for non inferiority is -10%.|Difference in proportion of responders|0.00069213||||||95.0|-0.0875|0.0888||||||The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.||0.0888|-0.0875|
91732557|NCT00375713|183359950|SUPERIORITY_OR_OTHER|||||||0.4369||95.0|||||ANCOVA|Pruritus score is adjusted on pruritus Baseline score.||The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor||||0.4369
91494165|NCT05048784|182860002|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUClast.|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.967|1.055|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.055|0.967|
91494166|NCT05048784|182860003|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUCinf.|Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.977|1.065|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.065|0.977|
91494167|NCT05048784|182860005|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for Cmax.|Ratio of geometric least squares means|1.001|||||TWO_SIDED|90.0|0.836|1.199|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.199|0.836|
91494168|NCT05048784|182860006|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUClast.|Ratio of geometric least squares means|1.447|||||TWO_SIDED|90.0|1.2|1.745|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.745|1.200|
91494169|NCT05048784|182860007|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUCinf.|Ratio of geometric least squares means|1.484|||||TWO_SIDED|90.0|1.236|1.783|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.783|1.236|
91494170|NCT01603056|182860010|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||t-test, 2 sided|||||||0.743
91494171|NCT01603056|182860011|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||t-test, 2 sided|||||||0.627
91494172|NCT01603056|182860012|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
91494173|NCT01603056|182860013|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||t-test, 2 sided|||||||0.641
91494174|NCT01603056|182860014|SUPERIORITY_OR_OTHER|||||||0.818|TWO_SIDED||||||t-test, 2 sided|||||||0.818
91494175|NCT01603056|182860015|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||t-test, 2 sided|||||||0.391
91701998|NCT00001656|183299050|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.59
91701999|NCT00001656|183299051|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.72
91702000|NCT00001656|183299052|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.27
91494176|NCT01603056|182860016|SUPERIORITY_OR_OTHER|||||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||0.497
91702001|NCT00001656|183299053|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|Covariate is baseline score||||||0.11
91702002|NCT00001656|183299054|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
91702003|NCT00001656|183299055|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
91702004|NCT00001656|183299057|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.73
91702005|NCT01313494|183299060|SUPERIORITY_OR_OTHER||LSM Difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.095|||Repeated measures ANCOVA|Independent variables: treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction.||The primary endpoint was tested in a confirmatory manner with a 2-sided significance level of 5%.||0.095|0.046|<0.0001
91705565|NCT02412878|183305769|SUPERIORITY||Odds Ratio (OR)|2.466|||<|0.0001|TWO_SIDED|95.0|1.707|3.563|||Fisher Exact||Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.|||3.563|1.707|<0.0001
91705566|NCT02412878|183305770|SUPERIORITY||Hazard Ratio (HR)|0.693||||0.0014|TWO_SIDED|95.0|0.544|0.883||Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.||0.883|0.544|0.0014
91705567|NCT02412878|183305770|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0033|TWO_SIDED|95.0|0.567|0.913|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||0.913|0.567|0.0033
91705568|NCT02412878|183305771|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.107|TWO_SIDED|95.0|0.563|1.138||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|||1.138|0.563|0.1070
91705569|NCT02412878|183305771|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1326|TWO_SIDED|95.0|0.578|1.164|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||1.164|0.578|0.1326
91705570|NCT02081014|183305777|SUPERIORITY_OR_OTHER||Point estimate ratio|0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705571|NCT02081014|183305777|SUPERIORITY_OR_OTHER||Point estimate ratio|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705572|NCT02081014|183305777|SUPERIORITY_OR_OTHER||Point estimate ratio|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705573|NCT02081014|183305778|SUPERIORITY_OR_OTHER||Point estimate ratio|0.74|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705574|NCT02081014|183305778|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705575|NCT02081014|183305778|SUPERIORITY_OR_OTHER||Point estimate ratio|0.59|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705576|NCT02081014|183305779|SUPERIORITY_OR_OTHER||Point point ratio|0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705577|NCT02081014|183305779|SUPERIORITY_OR_OTHER||Point estimate ratio|0.36|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705578|NCT02081014|183305779|SUPERIORITY_OR_OTHER||Point estimate ratio|0.53|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705579|NCT02081014|183305780|SUPERIORITY_OR_OTHER||Point estimate ratio|0.72|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91494177|NCT01603056|182860017|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||t-test, 2 sided|||||||0.222
91702006|NCT00550862|183299115|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
91494178|NCT01603056|182860018|SUPERIORITY_OR_OTHER|||||||0.438|TWO_SIDED||||||Fisher Exact|||||||0.438
91494179|NCT01603056|182860019|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED||||||t-test, 2 sided|||||||0.465
91494180|NCT01603056|182860020|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|||||||0.123
91494181|NCT01603056|182860021|SUPERIORITY_OR_OTHER|||||||0.719|TWO_SIDED||||||t-test, 2 sided|||||||0.719
91494182|NCT02270957|182860085|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
91494183|NCT02270957|182860086|SUPERIORITY|||||||0.587|||||||Chi-squared|||||||0.587
91494184|NCT02270957|182860087|SUPERIORITY|||||||0.587|TWO_SIDED|95.0||||None of the endpoints were met in any pre-specified unbiased Full Analysis Set analysis|Chi-squared|||||||0.587
91494185|NCT02535312|182860102|OTHER|||||||0.08|||||||Log Rank|||||||0.08
91494186|NCT02535312|182860103|OTHER|||||||0.15|||||||Log Rank|||||||0.15
91494187|NCT01539538|182860104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of - 15% for lower boundary of 95% confidence interval|difference in proportion|12.9|||<|0.001|TWO_SIDED|95.0|3.69|22.11|||one-sided, z-test|||||22.11|3.69|<0.001
91702007|NCT00550862|183299115|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
91702008|NCT00550862|183299115|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals||||<0.0001
91702009|NCT00550862|183299116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91702010|NCT00550862|183299117|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0005
91702011|NCT02248974|183299153|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.01
91702012|NCT02248974|183299154|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.47
91702013|NCT02248974|183299155|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.12
91702014|NCT02248974|183299156|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.79
91702015|NCT02248974|183299157|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
91702016|NCT02248974|183299158|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
91702017|NCT02248974|183299159|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91702018|NCT02248974|183299160|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91702019|NCT02248974|183299161|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91702020|NCT02248974|183299162|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
91702021|NCT02248974|183299163|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91702022|NCT02248974|183299165|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91702023|NCT02248974|183299166|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91702024|NCT02248974|183299170|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91702025|NCT02248974|183299171|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91702026|NCT02248974|183299172|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
91702027|NCT02248974|183299173|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
91702028|NCT02248974|183299174|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91702029|NCT02248974|183299175|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91702030|NCT02248974|183299177|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91702031|NCT02248974|183299178|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91702032|NCT02248974|183299179|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91702033|NCT02248974|183299186|SUPERIORITY|||||||0.98|||||||Fisher Exact|||||||0.98
91702034|NCT02248974|183299187|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
91702035|NCT01928797|183299193|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
91494188|NCT01539538|182860104|SUPERIORITY_OR_OTHER||Difference in proportion|12.9||||0.007|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.007
91702036|NCT01928797|183299194|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
91702037|NCT03436199|183299196|SUPERIORITY||Risk Difference (RD)|0.064||||0.0811|TWO_SIDED|95.0|-0.008|0.136|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.136|-0.008|0.0811
91702038|NCT03436199|183299196|SUPERIORITY||Risk Difference (RD)|0.098||||0.0104|TWO_SIDED|95.0|0.023|0.174|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.174|0.023|0.0104
91702039|NCT03436199|183299197|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.048||0.0162|TWO_SIDED|95.0|0.02|0.21|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.21|0.02|0.0162
91702040|NCT03436199|183299197|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0142|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.22|0.02|0.0142
91702041|NCT03436199|183299198|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.538||0.1424|TWO_SIDED|95.0|-1.85|0.27|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.27|-1.85|0.1424
91702042|NCT03436199|183299198|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.56||0.9467|TWO_SIDED|95.0|-1.14|1.06|||Mixed Models Analysis|Mixed models analysis with repeated measures||||1.06|-1.14|0.9467
91702043|NCT03436199|183299199|SUPERIORITY||Mean Difference (Net)|4.143|STANDARD_ERROR_OF_MEAN|1.7389||0.0176|TWO_SIDED|95.0|0.726|7.56|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.560|0.726|0.0176
91702044|NCT03436199|183299199|SUPERIORITY||Mean Difference (Net)|3.529|STANDARD_ERROR_OF_MEAN|1.8196||0.053|TWO_SIDED|95.0|-0.046|7.104|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.104|-0.046|0.0530
91702045|NCT00926536|183299206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.6|||<|0.001|TWO_SIDED|||||Decrease in DAP in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||<.001
91702046|NCT00926536|183299207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|158.3||||0.017|TWO_SIDED|||||Decrease in CD in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||0.017
91702047|NCT00435487|183299208|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-2.6||||||95.0|-8.59|3.4|||upper limit of 95% CI <= 10%||95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||3.40|-8.59|
91702048|NCT00435487|183299208|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|1.25||||||95.0|-3.02|5.52|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.52|-3.02|
91702049|NCT00435487|183299208|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-1.35||||||95.0|-8.62|5.93|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.93|-8.62|
91702050|NCT00435487|183299209|SUPERIORITY_OR_OTHER||Difference in proportion|1.27||||1||95.0|-1.2|3.73|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||3.73|-1.20|1.0000
91702051|NCT00435487|183299210|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
91705580|NCT02081014|183305780|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91513302|NCT01975389|182898150|SUPERIORITY||LS mean difference|-18.41|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-19.96|-16.86|||MMRM|||VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-16.86|-19.96|<0.001
91705581|NCT02081014|183305780|SUPERIORITY_OR_OTHER||Point estimate ratio|0.6|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705582|NCT02081014|183305781|SUPERIORITY_OR_OTHER||Point esimate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705583|NCT02081014|183305781|SUPERIORITY_OR_OTHER||Point estimate ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91494189|NCT03897465|182860105|NON_INFERIORITY|Pre-specified non-inferiority margin was 10%|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-10.0||Upper Limit= +Infinity|||||Descriptive analysis of the primary endpoint was provided on per protocol population. The overall difference LomatuellPro (LP) - UrgoTul (UT) of the % of patients meeting main efficacy criterion was calculated with 95% bilateral confidence interval (CI). If lower limit of the 95% CI did not exceed the -10% value of pre-specified non-inferiority margin, non-inferiority had to be accepted. As a sensitivity analysis, the same analysis was performed on mITT (modified Intention-to-treat) population.|||-10|
91494190|NCT02042183|182860174|OTHER|||||||0.1609||||||Cochran-Mantel-Haenszel (CMH) test stratified by baseline spontaneous bowel movement (SBM) frequency (\<1.5 or ≥1.5)|Cochran-Mantel-Haenszel|||||||0.1609
91494191|NCT00378378|182860182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from basline||||0.258
91494192|NCT00378378|182860182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.735
91702052|NCT00435487|183299211|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
91702053|NCT06350461|183299226|NON_INFERIORITY|The non-inferiority margin is -3.|Median Difference (Final Values)|-0.324|||<|0.0001|TWO_SIDED|95.0|-1.3|0.6||One-sided test for non-inferiority|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||0.6|-1.3|<0.0001
91702054|NCT06350461|183299227|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.733|TWO_SIDED|95.0|-0.4|0.4|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue|||0.4|-0.4|0.733
91702055|NCT06350461|183299228|SUPERIORITY||Mean Difference (Final Values)|-1.52||||0.226|TWO_SIDED|95.0|-4.1|0.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.9|-4.1|0.226
91702056|NCT06350461|183299229|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.857|TWO_SIDED|95.0|-1.8|2.1|||ANOVA|Adjusted for four dichotomous randomization strata|Direction of the difference is Discontinue - Continue|||2.1|-1.8|0.857
91702057|NCT06350461|183299230|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.16|TWO_SIDED|95.0|-0.25|1.54|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||1.54|-0.25|0.16
91702058|NCT06350461|183299231|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.56|TWO_SIDED|95.0|-1.04|0.57|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||0.57|-1.04|0.56
91494193|NCT00378378|182860182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.194
91494194|NCT00378378|182860183|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint||||0.361
91494195|NCT00378378|182860183|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.603
91702059|NCT06350461|183299232|SUPERIORITY||Difference in % Participants|1.1||||0.653|TWO_SIDED|95.0|-3.7|6.1|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants initiating acute antibiotics is the same in the Discontinue and Continue arms||6.1|-3.7|0.653
91702060|NCT06350461|183299233|SUPERIORITY||Difference in % Participants|0.5||||0.622|TWO_SIDED|95.0|-2.0|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one hospitalization is the same in Discontinue and Continue arms.||3.4|-2.0|0.622
91702061|NCT06350461|183299234|SUPERIORITY||Difference in % Participants|-1.1||||0.623|TWO_SIDED|95.0|-4.1|1.6|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one protocol-defined pulmonary exacerbation is the same in Discontinue and Continue arms.||1.6|-4.1|0.623
91702062|NCT06350461|183299235|SUPERIORITY||Difference in % Participants|11.7||||0.0165|TWO_SIDED|95.0|2.4|20.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||20.7|2.4|0.0165
91705584|NCT02081014|183305781|SUPERIORITY_OR_OTHER||Point estimate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705585|NCT02081014|183305782|SUPERIORITY_OR_OTHER||Point estimate ratio|0.75|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91494196|NCT00378378|182860183|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.193
91494197|NCT00601458|182860215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.7||||0.005||97.8|-73.6|-8.0||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (pregabalin - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-8.0|-73.6|0.005
91494198|NCT00601458|182860215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-65.4||||0.0001||97.8|-81.7|-34.6||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (naproxen - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-34.6|-81.7|0.0001
91494199|NCT00601458|182860216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.46||||0.004||95.0|0.183|2.95||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||2.95|0.183|0.004
91702063|NCT06350461|183299236|SUPERIORITY||Rate Ratio|1.29||||0.0958|TWO_SIDED|95.0|0.96|1.74|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the HS-discontinue and HS-continue arms are 1135.7 and 1163.9 weeks, respectively. Ratio is Discontinue / Continue.||1.74|0.96|0.0958
91732558|NCT00375713|183359951|SUPERIORITY_OR_OTHER|||||||0.3549||95.0|||||ANCOVA|pruritus severity score at baseline has been used as a covariate.||The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.||||0.3549
91732559|NCT00375713|183359952|SUPERIORITY_OR_OTHER|||||||0.7518||95.0|||||Cochran-Mantel-Haenszel|stratified on the prurity severity score at the previous day of randomization.||||||0.7518
91732560|NCT00323622|183360001|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|16.8||||0.08|TWO_SIDED|95.0|-2.5|32.4||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.40|-2.50|0.08
91732561|NCT00323622|183360001|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|11.8||||0.43|TWO_SIDED|95.0|-20.11|35.18||The p-value presented is the Wald Chi-square p-value from the Cox regression model|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||35.18|-20.11|0.43
91702064|NCT06350461|183299237|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
91702065|NCT02584998|183299241|OTHER||||||<|0.001|||||||Chi-squared|||In our power and sample size analysis, we assumed 15% screening rate in usual care, 25% with invitation, and 40% with mailed-FIT. A sample size of 500 (250/arm) will give 80% power for UC vs. screening invitation-reminder, and 152/arm will give a power of 80% for the screening invitation-reminder vs. mailed-FIT. Accounting for the possibility that up to 20% of participants could be ineligible post-randomization, we concluded that we should enroll 783 patients, 261 per arm, for this trial.||||<0.001
91702066|NCT04216589|183299275|OTHER|This was a single arm trial.|Mean Difference (Net)|-4.24|STANDARD_DEVIATION|4.05|<|0.001|TWO_SIDED|95.0|-5.41|-3.06|||Regression, Linear|||The study was powered to detect an absolute IHTG change of -5% assuming a null change of 0%, a standard deviation of absolute IHTG change of 9%, and 37 evaluable participants.||-3.06|-5.41|<0.001
91702067|NCT04216589|183299276|OTHER|This was a single arm trial.|Mean Difference (Net)|-31.33|STANDARD_DEVIATION|26.5|<|0.001|TWO_SIDED|95.0|-39.04|-23.62||No adjustment for multiple comparisons|Regression, Linear|||||-23.62|-39.04|<0.001
91702068|NCT04216589|183299280|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.77|STANDARD_DEVIATION|2.05|<|0.001|TWO_SIDED|95.0|-3.36|-2.17||Not adjusted for multiple comparisons.|Regression, Linear|||||-2.17|-3.36|<0.001
91702069|NCT04216589|183299281|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.15|STANDARD_DEVIATION|1.38|<|0.001|TWO_SIDED|95.0|-2.55|-1.75||Not adjusted for multiple comparisons|Regression, Linear|||||-1.75|-2.55|<0.001
91702070|NCT04216589|183299282|OTHER|This was a single arm trial.|Mean Difference (Net)|-7.8|STANDARD_DEVIATION|5.77|<|0.001|TWO_SIDED|95.0|-9.48|-6.13||Not adjusted for multiple comparisons|Regression, Linear|||||-6.13|-9.48|<0.001
91702071|NCT04216589|183299283|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.16|STANDARD_DEVIATION|3.96|<|0.001|TWO_SIDED|95.0|-7.3|-5.03||Not adjusted for multiple comparisons|Regression, Linear|||||-5.03|-7.30|<0.001
91702072|NCT04216589|183299284|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.66|STANDARD_DEVIATION|6.47|<|0.001|TWO_SIDED|95.0|-8.54|-4.78||Not adjusted for multiple comparisons|Regression, Linear|||||-4.78|-8.54|<0.001
91702073|NCT04216589|183299285|OTHER|This was a single arm trial.|Mean Difference (Net)|-5.53|STANDARD_DEVIATION|5.3|<|0.001|TWO_SIDED|95.0|-7.07|-3.99||Not adjusted for multiple comparisons|Regression, Linear|||||-3.99|-7.07|<0.001
91702074|NCT04216589|183299286|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.46|STANDARD_DEVIATION|5.82||0.092|TWO_SIDED|95.0|-3.17|0.25||Not adjusted for multiple comparisons|Regression, Linear|||||0.25|-3.17|0.092
91702075|NCT04216589|183299288|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.259|<|0.001|TWO_SIDED|95.0|-0.32|-0.17||Not adjusted for multiple comparisons|Regression, Linear|||||-0.17|-0.32|< 0.001
91702076|NCT04216589|183299289|OTHER|This was a single arm trial.|Mean Difference (Net)|-9.9|STANDARD_DEVIATION|16.6|<|0.001|TWO_SIDED|95.0|-14.7|-5.09||Not adjusted for multiple comparisons|Regression, Linear|||||-5.09|-14.70|<0.001
91702077|NCT04216589|183299290|OTHER|This was a single arm trial.|Mean Difference (Net)|-8.87|STANDARD_DEVIATION|11.5|<|0.001|TWO_SIDED|95.0|-12.26|-5.48||Not adjusted for multiple comparisons|Regression, Linear|||||-5.48|-12.26|<0.001
91702078|NCT04216589|183299291|OTHER|This was a single arm trial.|Mean Difference (Net)|-3.98|STANDARD_DEVIATION|23.1||0.25|TWO_SIDED|95.0|-10.84|2.89||Not adjusted for multiple comparisons|Regression, Linear|||||2.89|-10.84|0.25
91702079|NCT04216589|183299292|OTHER|This was a single arm trial.|Mean Difference (Net)|-11.93|STANDARD_DEVIATION|26.4||0.004|TWO_SIDED|95.0|-19.79|-4.08||Not adjusted for multiple comparisons|Regression, Linear|||||-4.08|-19.79|0.004
91702080|NCT04216589|183299293|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.04|STANDARD_DEVIATION|20.5||0.73|TWO_SIDED|95.0|-7.14|5.05||Not adjusted for multiple comparisons|Regression, Linear|||||5.05|-7.14|0.73
91702081|NCT04216589|183299294|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.91|STANDARD_DEVIATION|23.1||0.051|TWO_SIDED|95.0|-13.85|0.03||Not adjusted for multiple comparisons|Regression, Linear|||||0.03|-13.85|0.051
91702082|NCT04216589|183299295|OTHER|This was a single arm trial.|Mean Difference (Net)|2.04|STANDARD_DEVIATION|6.96||0.053|TWO_SIDED|95.0|-0.02|4.11||Not adjusted for multiple comparisons|Regression, Linear|||||4.11|-0.02|0.053
91702083|NCT04216589|183299296|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.78|STANDARD_DEVIATION|6.66||0.43|TWO_SIDED|95.0|-2.76|1.2||Not adjusted for multiple comparisons|Regression, Linear|||||1.20|-2.76|0.43
91702084|NCT04216589|183299297|OTHER|This was a single arm trial.|Mean Difference (Net)|-26.78|STANDARD_DEVIATION|64.8||0.007|TWO_SIDED|95.0|-46.04|-7.53||Not adjusted for multiple comparisons|Regression, Linear|||||-7.53|-46.04|0.007
91702085|NCT04216589|183299298|OTHER|This was a single arm trial.|Mean Difference (Net)|-18.65|STANDARD_DEVIATION|49.3||0.014|TWO_SIDED|95.0|-33.29|-4.01||Not adjusted for multiple comparisons|Regression, Linear|||||-4.01|-33.29|0.014
91702086|NCT04216589|183299299|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.72||||0.016|TWO_SIDED|95.0|0.55|0.94||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 12 (0.55; 95% CI: 0.43, 0.72) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 12.||0.94|0.55|0.016
91702087|NCT04216589|183299299|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.75||||0.033|TWO_SIDED|95.0|0.58|0.98||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 24 (0.58; 95% CI: 0.46, 0.74) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 24.||0.98|0.58|0.033
91702088|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-3.3|3.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 1||3.0|-3.3|< 0.001
91702089|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|24.2|||<|0.001|TWO_SIDED|95.0|18.7|30.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar|Type 3||30.0|18.7|< 0.001
91702090|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|3.0|||<|0.001|TWO_SIDED|95.0|0.0|6.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 4||6.4|0.0|< 0.001
91702091|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.5|||<|0.001|TWO_SIDED|95.0|-3.9|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 5||2.8|-3.9|< 0.001
91705586|NCT02081014|183305782|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705587|NCT02081014|183305782|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705588|NCT02081014|183305783|SUPERIORITY_OR_OTHER||Point estimate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705589|NCT02081014|183305783|SUPERIORITY_OR_OTHER||Point estimate ratio|0.7|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705590|NCT02081014|183305783|SUPERIORITY_OR_OTHER||Point estimate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705591|NCT02081014|183305784|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705592|NCT02081014|183305784|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
91705593|NCT02081014|183305784|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705594|NCT02081014|183305785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3693.2|STANDARD_ERROR_OF_MEAN|1520.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91705595|NCT02081014|183305785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7548.05|STANDARD_ERROR_OF_MEAN|1542.93||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||0.05
91705596|NCT02081014|183305785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3854.86|STANDARD_ERROR_OF_MEAN|1533.95|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91705597|NCT02081014|183305786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-144.9|STANDARD_ERROR_OF_MEAN|741.24|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
91705598|NCT02081014|183305786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1665.32|STANDARD_ERROR_OF_MEAN|696.97|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91705599|NCT02081014|183305786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1520.39|STANDARD_ERROR_OF_MEAN|700.92|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
91705600|NCT02081014|183305787|SUPERIORITY_OR_OTHER||Point estimate ratio|0.41|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705601|NCT02081014|183305787|SUPERIORITY_OR_OTHER||Point estimate ratio|0.43|STANDARD_ERROR_OF_MEAN|0.34|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705602|NCT02081014|183305787|SUPERIORITY_OR_OTHER||Point estimate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.81|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91702092|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-5.6|||<|0.001|TWO_SIDED|95.0|-10.0|-1.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6A||-1.6|-10.0|< 0.001
91702093|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-5.7|4.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6B||4.0|-5.7|< 0.001
91702094|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.7|||<|0.001|TWO_SIDED|95.0|-1.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 7F||2.7|-1.1|< 0.001
91702095|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.3|||<|0.001|TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 9V||4.6|-1.9|< 0.001
91702096|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-0.2|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 14||4.7|-0.2|< 0.001
91702097|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.2|||<|0.001|TWO_SIDED|95.0|-2.1|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 18C||4.7|-2.1|< 0.001
91702098|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.9|2.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19A||2.6|-1.9|< 0.001
91702099|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.0|1.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19F||1.9|-1.0|< 0.001
91702100|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.8|||<|0.001|TWO_SIDED|95.0|-2.9|6.5|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 23F||6.5|-2.9|< 0.001
91702101|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-2.0|3.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 1||3.9|-2.0|< 0.001
91702102|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|22.3|||<|0.001|TWO_SIDED|95.0|16.5|28.3|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 3||28.3|16.5|< 0.001
91702103|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.9|||<|0.001|TWO_SIDED|95.0|-1.4|5.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 4||5.4|-1.4|< 0.001
91702104|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 5||2.7|-4.1|< 0.001
91702105|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.2|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6A||2.8|-4.2|< 0.001
91702106|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-3.7|5.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6B||5.6|-3.7|< 0.001
91759185|NCT04038567|183411382|SUPERIORITY||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.46|0.67||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.67|-4.46|
91732562|NCT00323622|183360002|SUPERIORITY_OR_OTHER||1 - (R1/R2)|14.9||||0.11|TWO_SIDED|95.0|-3.88|30.28||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||30.28|-3.88|0.11
91732563|NCT00323622|183360002|SUPERIORITY_OR_OTHER||1 - (R1/R2)|12.79||||0.35|TWO_SIDED|95.0|-16.27|34.59||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||34.59|-16.27|0.35
91732564|NCT00323622|183360003|SUPERIORITY_OR_OTHER||1 - (R1/R2)|19.42||||0.01|TWO_SIDED|95.0|4.62|31.93||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||31.93|4.62|0.01
91702107|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.7|2.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 7F||2.4|-1.7|< 0.001
91702108|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-1.1|5.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 9V||5.2|-1.1|< 0.001
91702109|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.2|||<|0.001|TWO_SIDED|95.0|-2.8|3.1|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 14||3.1|-2.8|< 0.001
91702110|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.6|||<|0.001|TWO_SIDED|95.0|-0.3|5.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 18C||5.9|-0.3|< 0.001
91702111|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-2.5|2.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19A||2.2|-2.5|< 0.001
91702112|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.9|0.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19F||0.9|-2.9|< 0.001
91702113|NCT02987972|183299345|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|4.2|||<|0.001|TWO_SIDED|95.0|-0.1|8.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 23F||8.7|-0.1|< 0.001
91702114|NCT02987972|183299346|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.64|
91702115|NCT02987972|183299346|OTHER||GMC Ratio|1.98|||||TWO_SIDED|95.0|1.75|2.23|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.23|1.75|
91702116|NCT02987972|183299346|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.92|1.16|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.16|0.92|
91702117|NCT02987972|183299346|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.89|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.89|0.68|
91702118|NCT02987972|183299346|OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.47|0.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.63|0.47|
91702119|NCT02987972|183299346|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.26|0.84|
91702120|NCT02987972|183299346|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.92|0.73|
91702121|NCT02987972|183299346|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.00|0.77|
91702122|NCT02987972|183299346|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.03|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.03|0.75|
91702123|NCT02987972|183299346|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||0.84|0.66|
91702124|NCT02987972|183299346|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
91702125|NCT02987972|183299346|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.98|0.79|
91702126|NCT02987972|183299346|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.13|0.84|
91702127|NCT02987972|183299346|OTHER||GMC Ratio|92.05|||||TWO_SIDED|95.0|80.84|104.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||104.81|80.84|
91702128|NCT02987972|183299346|OTHER||GMC Ratio|34.41|||||TWO_SIDED|95.0|28.5|41.54|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||41.54|28.50|
91705603|NCT02081014|183305788|SUPERIORITY_OR_OTHER||Point estimate ratio|0.23|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705604|NCT02081014|183305788|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.88|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
91705605|NCT02081014|183305788|SUPERIORITY_OR_OTHER||Point estimate ratio|3.23|STANDARD_ERROR_OF_MEAN|3.84|>|0.05|TWO_SIDED||||||Regression, Linear||Geometric means|||||>0.05
91705606|NCT01026818|183305789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.675|TWO_SIDED|95.0|0.63|2.06||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||2.06|0.63|0.675
91705607|NCT01026818|183305789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.704|TWO_SIDED|95.0|0.48|1.65||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||1.65|0.48|0.704
91705608|NCT01026818|183305790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.016|TWO_SIDED|95.0|1.16|3.99||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||3.99|1.16|0.016
91705609|NCT01026818|183305790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.21|TWO_SIDED|95.0|0.79|2.85||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.85|0.79|0.210
91705610|NCT01026818|183305790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.273|TWO_SIDED|95.0|0.79|2.28||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.28|0.79|0.273
91705611|NCT01026818|183305790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.259|TWO_SIDED|95.0|0.8|2.29||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.29|0.80|0.259
91705612|NCT01026818|183305791|SUPERIORITY_OR_OTHER||LS Mean Differences|2.8|STANDARD_ERROR_OF_MEAN|1.03||0.007|TWO_SIDED|95.0|0.76|4.83||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.83|0.76|0.007
91705613|NCT01026818|183305791|SUPERIORITY_OR_OTHER||LS Mean differences|1.59|STANDARD_ERROR_OF_MEAN|1.02||0.118|TWO_SIDED|95.0|-0.41|3.6||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.60|-0.41|0.118
91705614|NCT01026818|183305791|SUPERIORITY_OR_OTHER||LS Mean Differences|0.26|STANDARD_ERROR_OF_MEAN|1.04||0.802|TWO_SIDED|95.0|-1.79|2.31||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.31|-1.79|0.802
91705615|NCT01026818|183305791|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.22|STANDARD_ERROR_OF_MEAN|1.02||0.83|TWO_SIDED|95.0|-2.23|1.79||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.79|-2.23|0.830
91732565|NCT00323622|183360003|SUPERIORITY_OR_OTHER||1 - (R1/R2)|7.08||||0.54|TWO_SIDED|95.0|-17.37|26.44||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||26.44|-17.37|0.54
91732566|NCT00323622|183360004|SUPERIORITY_OR_OTHER||1 - (R1/R2)|16.79||||0.1|TWO_SIDED|95.0|-3.75|33.25||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||33.25|-3.75|0.10
91732567|NCT00323622|183360004|SUPERIORITY_OR_OTHER||1 - (R1/R2)|6.31||||0.7|TWO_SIDED|95.0|-31.0|32.99||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.99|-31.00|0.70
91732568|NCT02085720|183360030|NON_INFERIORITY_OR_EQUIVALENCE|Data were given as means and standard deviations, unless otherwise stated. AHI was categorized as ≥ 5, ≥ 10, ≥ 15 and ≥ 20. The frequency distribution of responses on the SHQ and their relationship to AHI was assessed with the chi-squared analysis. The association of variables such as age, BMI, neck circumference, ESS and sleep health questionnaire responses versus AHI was evaluated using one-way analysis of variance and Pearson Correlation Analysis.|||||<|0.05|||||||ANOVA|||||||<0.05
91732569|NCT05293314|183360078|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.964|||<|0.05|TWO_SIDED|95.0|0.932|0.996|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.996|0.932|<0.05
91732570|NCT05293314|183360078|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.932|||<|0.05|TWO_SIDED|95.0|0.879|0.982|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.982|0.879|<0.05
91759186|NCT04038567|183411382|SUPERIORITY||Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-3.31|1.83||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.83|-3.31|
91759187|NCT02726022|183411385|SUPERIORITY_OR_OTHER|||||||0.647|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.647
91702129|NCT02987972|183299346|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.74|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.94|0.74|
91702130|NCT02987972|183299346|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.71|2.18|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.18|1.71|
91702131|NCT02987972|183299346|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.14|0.90|
91702132|NCT02987972|183299346|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.94|0.72|
91702133|NCT02987972|183299346|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.66|0.49|
91702134|NCT02987972|183299346|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.10|0.74|
91759188|NCT02726022|183411385|SUPERIORITY_OR_OTHER|||||||0.373|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.373
91759189|NCT02726022|183411386|SUPERIORITY_OR_OTHER|||||||0.049|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.049
91759190|NCT02726022|183411386|SUPERIORITY_OR_OTHER|||||||0.86|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.860
91494200|NCT00601458|182860216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.7|||<|0.001||95.0|1.77|6.72||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||6.72|1.77|<0.001
91732571|NCT05293314|183360079|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
91732572|NCT05293314|183360079|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
91732573|NCT05293314|183360080|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|92.5|||||TWO_SIDED|95.0|86.2|98.8||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||98.8|86.2|
91732574|NCT05293314|183360080|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|73.9|||||TWO_SIDED|95.0|56.0|91.9||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||91.9|56|
91732575|NCT00934180|183360081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.0||||||90.0|95.1|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|95.1|
91732576|NCT00934180|183360082|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.3|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|95.3|
91732577|NCT00934180|183360083|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.2|108.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108|95.2|
91732578|NCT02613507|183360084|SUPERIORITY|||||||0.0006|TWO_SIDED|||||The boundary for statistical significance requires the p-value to be less than 0.0231|Stratified weighted Log-Rank|Stratified weighted using G \[rho=0, gamma=1\] Fleming and Harrington.||||||0.0006
91732579|NCT02613507|183360084|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|97.7|0.52|0.9|||Stratified Cox Proportional Hazard Model|||||0.90|0.52|
91702135|NCT02987972|183299346|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.72|0.91|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.91|0.72|
91702136|NCT02987972|183299346|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.22|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.22|0.94|
91702137|NCT02987972|183299346|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.71|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.97|0.71|
91702138|NCT02987972|183299346|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.12|0.88|
91702139|NCT02987972|183299346|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
91732580|NCT02613507|183360084|SUPERIORITY|||||||0.0017|||||||Log Rank|regular stratified log-rank test p-value||||||0.0017
91732581|NCT02471144|183360117|SUPERIORITY||Odds Ratio (OR)|25.78|||<|0.0001|TWO_SIDED|95.0|7.08|114.66|||Regression, Logistic|||vs Placebo||114.66|7.08|<.0001
91732582|NCT02471144|183360117|SUPERIORITY||Odds Ratio (OR)|22.65|||<|0.0001|TWO_SIDED|95.0|6.31|98.93|||Regression, Logistic|||vs Placebo||98.93|6.31|<.0001
91732583|NCT02471144|183360118|SUPERIORITY||Odds Ratio (OR)|51.77|||<|0.0001|TWO_SIDED|95.0|10.02|538.64|||Regression, Logistic|||vs Placebo||538.64|10.02|<.0001
91732584|NCT02471144|183360118|SUPERIORITY||Odds Ratio (OR)|32.52|||<|0.0001||95.0|6.48|329.52|||Regression, Logistic|||vs Placebo||329.52|6.48|<.0001
91732585|NCT02471144|183360119|SUPERIORITY||Odds Ratio (OR)|72.5|||<|0.0001|TWO_SIDED|95.0|55.9|84.9|||Regression, Logistic|||vs Placebo||84.9|55.9|<.0001
91732586|NCT02471144|183360119|SUPERIORITY||Odds Ratio (OR)|67.5|||<|0.0001|TWO_SIDED|95.0|50.8|80.9|||Regression, Logistic|||vs Placebo||80.9|50.8|<.0001
91759191|NCT02726022|183411387|SUPERIORITY_OR_OTHER|||||||0.921|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.921
91702140|NCT02987972|183299346|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.01|0.81|
91702141|NCT02987972|183299346|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.01|1.37|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.37|1.01|
91702142|NCT02987972|183299346|OTHER||GMC Ratio|80.09|||||TWO_SIDED|95.0|70.3|91.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||91.24|70.30|
91702143|NCT02987972|183299346|OTHER||GMC Ratio|32.92|||||TWO_SIDED|95.0|27.25|39.78|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||39.78|27.25|
91702144|NCT02987972|183299347|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||3.2|-3.1|
91702145|NCT02987972|183299347|OTHER||Difference in Percentages|2.0|||||TWO_SIDED|95.0|-0.7|5.0||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||5.0|-0.7|
91702146|NCT02987972|183299348|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
91702147|NCT02987972|183299348|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
91732587|NCT03977155|183360135|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.35||0.3776|TWO_SIDED|95.0|-1.0|0.38|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.38|-1.00|0.3776
91732588|NCT03977155|183360135|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.73|0.82||||||Statistical Analysis 2||0.82|-0.73|
91732589|NCT03977155|183360135|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.403|||TWO_SIDED|95.0|-1.41|0.19||||||Statistical Analysis 3||0.19|-1.41|
91732590|NCT03977155|183360135|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.13|1.44||||||Statistical Analysis 4||1.44|-0.13|
91732591|NCT03977155|183360137|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.211||0.884|TWO_SIDED|95.0|-0.45|0.39|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.39|-0.45|0.8840
91732592|NCT03977155|183360137|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.249|||TWO_SIDED|95.0|-0.6|0.39||||||Statistical Analysis 2||0.39|-0.60|
91732593|NCT03977155|183360137|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.43|0.49||||||Statistical Analysis 3||0.49|-0.43|
91732594|NCT03977155|183360137|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|-0.63|0.36||||||Statistical Analysis 4||0.36|-0.63|
91732595|NCT03977155|183360138|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.228||0.4725|TWO_SIDED|95.0|-0.62|0.29|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.29|-0.62|0.4725
91732596|NCT03977155|183360138|SUPERIORITY||Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|95.0|-0.71|0.31||||||Statistical Analysis 2||0.31|-0.71|
91732597|NCT03977155|183360138|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.62|0.37||||||Statistical Analysis 3||0.37|-0.62|
91732598|NCT03977155|183360138|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|95.0|-0.6|0.45||||||Statistical Analysis 4||0.45|-0.60|
91732599|NCT03977155|183360139|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5693|TWO_SIDED|95.0|-0.28|0.51|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.51|-0.28|0.5693
91732600|NCT03977155|183360139|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.35|0.63||||||Statistical Analysis 2||0.63|-0.35|
91732601|NCT03977155|183360139|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.33|0.51||||||Statistical Analysis 3||0.51|-0.33|
91732602|NCT03977155|183360139|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.41|0.51||||||Statistical Analysis 4||0.51|-0.41|
91732603|NCT03977155|183360140|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-7.71|STANDARD_ERROR_OF_MEAN|25.208||0.7603|TWO_SIDED|95.0|-57.76|42.33|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||42.33|-57.76|0.7603
91732604|NCT03977155|183360140|SUPERIORITY||Mean Difference (Net)|24.0|STANDARD_ERROR_OF_MEAN|29.087|||TWO_SIDED|95.0|-34.22|82.22||||||Statistical Analysis 2||82.22|-34.22|
91732605|NCT03977155|183360140|SUPERIORITY||Mean Difference (Net)|-33.42|STANDARD_ERROR_OF_MEAN|27.285|||TWO_SIDED|95.0|-87.91|21.07||||||Statistical Analysis 3||21.07|-87.91|
91732606|NCT03977155|183360140|SUPERIORITY||Mean Difference (Net)|57.42|STANDARD_ERROR_OF_MEAN|28.174|||TWO_SIDED|95.0|1.16|113.69||||||Statistical Analysis 4||113.69|1.16|
91732607|NCT03977155|183360141|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.2149|TWO_SIDED|95.0|-0.44|0.1|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.10|-0.44|0.2149
91732608|NCT03977155|183360141|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.27|0.29||||||Statistical Analysis 2||0.29|-0.27|
91732609|NCT03977155|183360141|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.64|-0.01||||||Statistical Analysis 3||-0.01|-0.64|
91702148|NCT02987972|183299349|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.3|12.8|||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||12.8|-0.3|
91513303|NCT01975389|182898150|SUPERIORITY||LS mean difference|-29.2|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-31.44|-26.96|||MMRM|||RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-26.96|-31.44|<0.001
91702149|NCT02987972|183299349|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.2|12.9|||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||12.9|-0.2|
91702150|NCT02987972|183299350|OTHER||Difference in Percentages|0.7||||0.772|TWO_SIDED|95.0|-3.9|5.2|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||5.2|-3.9|0.772
91702151|NCT02987972|183299350|OTHER||Difference in Percentages|2.6||||0.235|TWO_SIDED|95.0|-1.7|7.0|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||7.0|-1.7|0.235
91702152|NCT02987972|183299351|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.76|0.62|
91702153|NCT02987972|183299351|OTHER||GMC Ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.28|1.75|
91702154|NCT02987972|183299351|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.07|0.86|
91702155|NCT02987972|183299351|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.78|0.96|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.96|0.78|
91702156|NCT02987972|183299351|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.65|0.50|
91702157|NCT02987972|183299351|OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|1.06|1.39|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.39|1.06|
91702158|NCT02987972|183299351|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.82|0.67|
91702159|NCT02987972|183299351|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.95|0.74|
91702160|NCT02987972|183299351|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.76|0.58|
91702161|NCT02987972|183299351|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Type 18C|IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|0.90|0.72|
91702162|NCT02987972|183299351|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.69|0.91|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.91|0.69|
91732610|NCT03977155|183360141|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.02|0.65||||||Statistical Analysis 4||0.65|0.02|
91732611|NCT03440385|183360180|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8125|TWO_SIDED|95.0|0.66|1.39|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.39|0.66|0.8125
91702163|NCT02987972|183299351|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.85|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.85|0.65|
91702164|NCT02987972|183299351|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.07|0.79|
91702165|NCT02987972|183299351|OTHER||GMC Ratio|27.82|||||TWO_SIDED|95.0|24.64|31.4|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|type 22F||31.40|24.64|
91702166|NCT02987972|183299351|OTHER||GMC Ratio|25.57|||||TWO_SIDED|95.0|22.61|28.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||28.92|22.61|
91702167|NCT02987972|183299351|OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.69|0.85|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.85|0.69|
91702168|NCT02987972|183299351|OTHER||GMC Ratio|2.1|||||TWO_SIDED|95.0|1.84|2.39|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.39|1.84|
91702169|NCT02987972|183299351|OTHER||GMC Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.05|0.85|
91702170|NCT02987972|183299351|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.95|0.77|
91732612|NCT03440385|183360181|SUPERIORITY||Odds Ratio (OR)|1.13||||0.54|TWO_SIDED|95.0|0.77|1.66|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.66|0.77|0.5400
91732613|NCT03440385|183360182|SUPERIORITY||Odds Ratio (OR)|1.28||||0.2411|TWO_SIDED|95.0|0.85|1.95|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.95|0.85|0.2411
91494201|NCT00518986|182860217|SUPERIORITY_OR_OTHER|||||||0.3043||95.0|||||ANCOVA|Study drug was fixed factor and corresponding baseline value was a covariate.||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.3043
91702171|NCT02987972|183299351|OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.57|0.74|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.74|0.57|
91494202|NCT00518986|182860218|SUPERIORITY_OR_OTHER|||||||0.012|||||||Chi-squared|P-value for comparison is from a Pearson's chi-square test||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.0120
91494203|NCT00518986|182860219|SUPERIORITY_OR_OTHER|||||||0.0027||||||Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.|ANCOVA|||Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.||||0.0027
91702172|NCT02987972|183299351|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.97|1.28|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.28|0.97|
91494204|NCT00518986|182860220|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
91494205|NCT00518986|182860221|SUPERIORITY_OR_OTHER|||||||0.3145|||||||ANCOVA|||||||0.3145
91494206|NCT00518986|182860222|SUPERIORITY_OR_OTHER|||||||0.2196|||||||ANCOVA|||||||0.2196
91702173|NCT02987972|183299351|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.86|0.70|
91702174|NCT02987972|183299351|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.76|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.97|0.76|
91702175|NCT02987972|183299351|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.53|0.7|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.70|0.53|
91702176|NCT02987972|183299351|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.07|1.34|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.34|1.07|
91494207|NCT00518986|182860223|SUPERIORITY_OR_OTHER|||||||0.2017||||||P-value is from Pearson's chi-square test|Chi-squared|||||||0.2017
91494208|NCT00518986|182860224|SUPERIORITY_OR_OTHER|||||||0.0032||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0032
91494209|NCT00518986|182860225|SUPERIORITY_OR_OTHER|||||||0.0207||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0207
91494210|NCT00518986|182860226|SUPERIORITY_OR_OTHER|||||||0.0529||||||P-value was generated from a Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||||||0.0529
91494211|NCT00518986|182860227|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
91702177|NCT02987972|183299351|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.94|0.71|
91702178|NCT02987972|183299351|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.94|0.73|
91702179|NCT02987972|183299351|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.99|1.35|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.35|0.99|
91494212|NCT00518986|182860228|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|||||||0.0064
91494213|NCT00518986|182860229|SUPERIORITY_OR_OTHER|||||||0.1072|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1072
91702180|NCT02987972|183299351|OTHER||GMC Ratio|26.3|||||TWO_SIDED|95.0|23.31|29.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||29.68|23.31|
91494214|NCT00518986|182860230|SUPERIORITY_OR_OTHER|||||||0.0355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0355
91494215|NCT00518986|182860231|SUPERIORITY_OR_OTHER|||||||0.0591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0591
91494216|NCT00518986|182860232|SUPERIORITY_OR_OTHER|||||||0.0025|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0025
91702181|NCT02987972|183299351|OTHER||GMC Ratio|24.1|||||TWO_SIDED|95.0|21.32|27.25|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||27.25|21.32|
91702182|NCT02987972|183299352|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.62|
91702183|NCT02987972|183299352|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.27|1.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.63|1.27|
91702184|NCT02987972|183299352|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.02|0.76|
91702185|NCT02987972|183299352|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.84|0.63|
91702186|NCT02987972|183299352|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.82|0.62|
91702187|NCT02987972|183299352|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.22|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.22|0.93|
91702188|NCT02987972|183299352|OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.77|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.77|0.59|
91702189|NCT02987972|183299352|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.79|0.60|
91702190|NCT02987972|183299352|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.02|0.76|
91702191|NCT02987972|183299352|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.08|0.81|
91702192|NCT02987972|183299352|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.01|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||1.01|0.78|
91702193|NCT02987972|183299352|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.10|0.85|
91702194|NCT02987972|183299352|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.64|0.87|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||0.87|0.64|
91702195|NCT02987972|183299352|OTHER||GMC Ratio|149.69|||||TWO_SIDED|95.0|130.23|172.06|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||172.06|130.23|
91702196|NCT02987972|183299352|OTHER||GMC Ratio|90.35|||||TWO_SIDED|95.0|79.93|102.12|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||102.12|79.93|
91702197|NCT02987972|183299352|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.93|0.71|
91494217|NCT00518986|182860233|SUPERIORITY_OR_OTHER|||||||0.0794||||||P-value for treatment comparison is from Pearson's chi-square test|Chi-squared|||||||0.0794
91494218|NCT00518986|182860234|SUPERIORITY_OR_OTHER|||||||0.0888||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||||||0.0888
91494219|NCT00518986|182860235|SUPERIORITY_OR_OTHER|||||||0.0433||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0433
91494220|NCT00518986|182860236|SUPERIORITY_OR_OTHER|||||||0.0105||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0105
91494221|NCT00518986|182860237|SUPERIORITY_OR_OTHER|||||||0.0523|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0523
91759192|NCT02726022|183411387|SUPERIORITY_OR_OTHER|||||||0.962|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.962
91494222|NCT00518986|182860238|SUPERIORITY_OR_OTHER|||||||0.0289|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0289
91494223|NCT00518986|182860239|SUPERIORITY_OR_OTHER|||||||0.1272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1272
91494224|NCT00518986|182860240|SUPERIORITY_OR_OTHER|||||||0.0349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0349
91494225|NCT00518986|182860241|SUPERIORITY_OR_OTHER|||||||0.0094|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0094
91702198|NCT02987972|183299352|OTHER||GMC Ratio|1.48|||||TWO_SIDED|95.0|1.31|1.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.68|1.31|
91702199|NCT02987972|183299352|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||0.94|0.70|
91702200|NCT02987972|183299352|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.79|0.60|
91702201|NCT02987972|183299352|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.76|0.58|
91702202|NCT02987972|183299352|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||0.95|0.72|
91702203|NCT02987972|183299352|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.81|0.62|
91702204|NCT02987972|183299352|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.88|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.88|0.67|
91702205|NCT02987972|183299352|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.98|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.98|0.73|
91702206|NCT02987972|183299352|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.24|0.93|
91702207|NCT02987972|183299352|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.93|0.72|
91702208|NCT02987972|183299352|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.03|0.79|
91702209|NCT02987972|183299352|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.08|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.08|0.79|
91702210|NCT02987972|183299352|OTHER||GMC Ratio|131.23|||||TWO_SIDED|95.0|114.05|151.0|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||151.00|114.05|
91702211|NCT02987972|183299352|OTHER||GMC Ratio|78.99|||||TWO_SIDED|95.0|69.82|89.36|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||89.36|69.82|
91732614|NCT03440385|183360183|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7469|TWO_SIDED|95.0|0.67|1.34|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.34|0.67|0.7469
91494226|NCT00518986|182860242|SUPERIORITY_OR_OTHER|||||||0.0754|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0754
91494227|NCT00518986|182860243|SUPERIORITY_OR_OTHER|||||||0.0105|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0105
91494228|NCT00518986|182860244|SUPERIORITY_OR_OTHER|||||||0.2888|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2888
91494229|NCT00518986|182860245|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0130
91702212|NCT01726036|183299365|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
91702213|NCT01047332|183299366|OTHER|||||||0.53|||||||Log Rank|||||||0.530
91702214|NCT01047332|183299367|OTHER|||||||0.997|||||||Log Rank|||||||0.997
91702215|NCT03521817|183299370|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.14|<|0.231|TWO_SIDED||||||t-test, 2 sided|||||||<0.231
91702216|NCT00778102|183299404|SUPERIORITY_OR_OTHER||Difference in Resection Rate|12.3||||0.2707|TWO_SIDED|95.0|-11.0|35.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with R0, R1, or R2.||35.5|-11.0|0.2707
91494230|NCT00518986|182860246|SUPERIORITY_OR_OTHER|||||||0.0354|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0354
91494231|NCT00518986|182860247|SUPERIORITY_OR_OTHER|||||||0.3854||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7 after baseline||||0.3854
91494232|NCT00518986|182860248|SUPERIORITY_OR_OTHER|||||||0.0145||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders were defined as subjects with worst fatigue score \< 7||||0.0145
91494233|NCT00518986|182860249|SUPERIORITY_OR_OTHER|||||||0.6475||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders were patients with worst fatigue scores \< 7||||0.6475
91494234|NCT00518986|182860250|SUPERIORITY_OR_OTHER|||||||0.0118||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7||||0.0118
91494235|NCT00518986|182860251|SUPERIORITY_OR_OTHER|||||||0.3483||||||P-value for the treatment comparison is from the Pearson's chi-square test.|Chi-squared|||Responders are subjects with a worst fatigue score of \< 7||||0.3483
91494236|NCT00518986|182860252|SUPERIORITY_OR_OTHER|||||||0.0879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0879
91494237|NCT00518986|182860253|SUPERIORITY_OR_OTHER|||||||0.0277|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0277
91494238|NCT00518986|182860254|SUPERIORITY_OR_OTHER|||||||0.1245|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1245
91528805|NCT00619476|182933579|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-1.07||||0.002|TWO_SIDED|95.0|-1.68|-0.45||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.45|-1.68|0.002
91528806|NCT00214903|182933625|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE, region, and HRT user status.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||1.3|0.5|
91494239|NCT00518986|182860255|SUPERIORITY_OR_OTHER|||||||0.0305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0305
91494240|NCT00518986|182860256|SUPERIORITY_OR_OTHER|||||||0.0129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0129
91494241|NCT00518986|182860257|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0308
91494242|NCT00518986|182860258|SUPERIORITY_OR_OTHER|||||||0.0679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0679
91494243|NCT00518986|182860259|SUPERIORITY_OR_OTHER|||||||0.0153|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0153
91494244|NCT00518986|182860260|SUPERIORITY_OR_OTHER|||||||0.0296|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0296
91494245|NCT00518986|182860261|SUPERIORITY_OR_OTHER|||||||0.0107|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0107
91494246|NCT00518986|182860262|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as patients with a total score on FOSQ \> 17.9||||0.0100
91494247|NCT00518986|182860263|SUPERIORITY_OR_OTHER|||||||0.0854||95.0||||P-value for treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score of \> 17.9||||0.0854
91494248|NCT00518986|182860264|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score \> 17.9||||0.0027
91494249|NCT00518986|182860265|SUPERIORITY_OR_OTHER|||||||0.0189||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||Responders are defined as subjects who had a total score of \> 17.9||||0.0189
91494250|NCT00518986|182860266|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with total score \> 17.9||||0.0240
91494251|NCT00518986|182860267|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3320
91528807|NCT00214903|182933626|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.3|0.8|||||Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||0.8|0.3|
91732615|NCT03440385|183360184|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4255|TWO_SIDED|95.0|0.75|1.97|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.97|0.75|0.4255
91494252|NCT00518986|182860268|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8930
91494253|NCT00518986|182860269|SUPERIORITY_OR_OTHER|||||||0.1774||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1774
91494254|NCT00518986|182860270|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1000
91528808|NCT01625910|182933627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.21||||||Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.||0.21|-0.10|
91528809|NCT01625910|182933628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.74|0.4||||||unadjusted net difference between groups||0.40|-0.74|
91528810|NCT02959138|182933629|OTHER|The test-to-reference ratio (geometric least squares mean (GLSM) ratio) and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.68|||||TWO_SIDED|90.0|86.94|143.47||||||The Estimate statement was used to produce the point estimate and the corresponding 90% confidence interval of the difference in PK parameters of interest on a logarithmic scale.||143.47|86.94|
91528811|NCT02959138|182933629|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.04|||||TWO_SIDED|90.0|78.47|146.02||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||146.02|78.47|
91528812|NCT02959138|182933630|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.92|||||TWO_SIDED|90.0|86.92|144.12||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||144.12|86.92|
91528813|NCT02959138|182933630|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.69|||||TWO_SIDED|90.0|79.63|145.65||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||145.65|79.63|
91528814|NCT02959138|182933631|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|102.0|||||TWO_SIDED|90.0|81.42|127.79||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||127.79|81.42|
91528815|NCT02959138|182933631|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|87.8|||||TWO_SIDED|90.0|68.14|113.13||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||113.13|68.14|
91528816|NCT01327547|182933692|SUPERIORITY_OR_OTHER||Difference in proportion|-0.002||||0.4598|TWO_SIDED|95.0|-0.0417|0.0376|||Cochran-Mantel-Haenszel||Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.||0.0376|-0.0417|0.4598
91732616|NCT03440385|183360185|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9313|TWO_SIDED|95.0|0.6|1.76|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.76|0.60|0.9313
91494255|NCT00518986|182860271|SUPERIORITY_OR_OTHER|||||||0.2428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2428
91494256|NCT00518986|182860272|SUPERIORITY_OR_OTHER|||||||0.1816||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1816
91528817|NCT01327547|182933693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0167|||||TWO_SIDED|95.0|-0.0653|0.0319|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.|||0.0319|-0.0653|
91528818|NCT01327547|182933693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0177|||||TWO_SIDED|95.0|-0.0805|0.0452|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.|||0.0452|-0.0805|
91528819|NCT01327547|182933698|SUPERIORITY_OR_OTHER||Difference in proportion|-0.015|||||TWO_SIDED|95.0|-0.1484|0.1185|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.||0.1185|-0.1484|
91528820|NCT01327547|182933698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0255|||||TWO_SIDED|95.0|-0.1784|0.1274|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.||0.1274|-0.1784|
91528821|NCT01327547|182933698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|||||TWO_SIDED|95.0|-0.2421|0.0761|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.||0.0761|-0.2421|
91528822|NCT01327547|182933699|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|-41.12||||0.1174|TWO_SIDED|95.0|-92.72|10.49|||ANCOVA||Difference in Least Square (LS) Mean|The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||10.49|-92.72|0.1174
91528823|NCT01327547|182933699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-21.96||||0.593|TWO_SIDED|95.0|-103.05|59.12|||ANCOVA||Difference in LS Mean|The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||59.12|-103.05|0.5930
91528824|NCT01327547|182933699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-48.26||||0.0669|TWO_SIDED|95.0|-99.93|3.41|||ANCOVA|||The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||3.41|-99.93|0.0669
91528825|NCT01327547|182933699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-65.28||||0.1799|TWO_SIDED|95.0|-161.07|30.5|||ANCOVA|||The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||30.50|-161.07|0.1799
91528826|NCT01327547|182933699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-27.71||||0.3859|TWO_SIDED|95.0|-90.71|35.29|||ANCOVA|||The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||35.29|-90.71|0.3859
91528827|NCT01327547|182933699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-31.86||||0.5571|TWO_SIDED|95.0|-138.93|75.21|||ANCOVA|||The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||75.21|-138.93|0.5571
91528828|NCT01327547|182933700|SUPERIORITY_OR_OTHER||Difference in LS Mean|-56.06||||0.0153|TWO_SIDED|95.0|-101.2|-10.92|||ANCOVA||Difference in LS Mean|The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||-10.92|-101.20|0.0153
91528829|NCT01327547|182933700|SUPERIORITY_OR_OTHER||Difference in LS Mean|-44.93||||0.0947|TWO_SIDED|95.0|-97.72|7.87|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||7.87|-97.72|0.0947
91732617|NCT03440385|183360186|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4339|TWO_SIDED|95.0|0.7|2.31|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.31|0.70|0.4339
91732618|NCT03440385|183360187|SUPERIORITY||Odds Ratio (OR)|1.3||||0.333|TWO_SIDED|95.0|0.77|2.2|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.20|0.77|0.3330
91732619|NCT03440385|183360188|SUPERIORITY||Odds Ratio (OR)|1.04||||0.82|TWO_SIDED|95.0|0.74|1.47|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.47|0.74|0.8200
91732620|NCT03440385|183360189|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7776|TWO_SIDED|95.0|0.71|1.59|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.59|0.71|0.7776
91732621|NCT03440385|183360190|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1187|TWO_SIDED|95.0|0.92|2.11|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.11|0.92|0.1187
91732622|NCT03440385|183360191|SUPERIORITY||Odds Ratio (OR)|1.28||||0.403|TWO_SIDED|95.0|0.72|2.26|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.26|0.72|0.4030
91732623|NCT03440385|183360192|SUPERIORITY||Odds Ratio (OR)|0.79||||0.563|TWO_SIDED|95.0|0.35|1.78|||Mantel Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.78|0.35|0.5630
91732624|NCT00488293|183360193|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
91732625|NCT00488293|183360194|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Chi-squared|||||||0.88
91732626|NCT00488293|183360195|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
91732627|NCT00488293|183360196|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
91732628|NCT00488293|183360197|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
91732629|NCT00488293|183360198|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
91528830|NCT01327547|182933700|SUPERIORITY_OR_OTHER||Difference in LS Mean|-29.75||||0.3595|TWO_SIDED|95.0|-93.74|34.24|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||34.24|-93.74|0.3595
91528831|NCT01327547|182933701|SUPERIORITY_OR_OTHER||Difference in LS Mean|-2.53||||0.4476|TWO_SIDED|95.0|-9.11|4.05|||ANCOVA||Difference in LS Mean|The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||4.05|-9.11|0.4476
91528832|NCT01327547|182933701|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.67||||0.3012|TWO_SIDED|95.0|-0.61|1.96|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.96|-0.61|0.3012
91732630|NCT00488293|183360199|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
91732631|NCT00488293|183360200|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
91732632|NCT00488293|183360201|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
91732633|NCT00488293|183360202|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Chi-squared|||||||0.65
91732634|NCT01425814|183360226|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.219|0.298|||ANCOVA|||||0.298|0.219|<0.0001
91732635|NCT01425814|183360226|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.233|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.194|0.273|||ANCOVA|||||0.273|0.194|<0.0001
91732636|NCT01425814|183360226|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.203|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.164|0.242|||ANCOVA|||||0.242|0.164|<0.0001
91732637|NCT01425814|183360226|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.062|0.141|||ANCOVA|||||0.141|0.062|<0.0001
91732638|NCT01358734|183360240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.789||||0.119|TWO_SIDED|95.0|0.861|3.718|||Log Rank|||||3.718|0.861|0.119
91732639|NCT01358734|183360240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.659||||0.014|TWO_SIDED|95.0|1.214|5.822|||Log Rank|||||5.822|1.214|0.014
91732640|NCT01358734|183360240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367||||0.356|TWO_SIDED|95.0|0.704|2.653|||Log Rank|||||2.653|0.704|0.356
91732641|NCT00127439|183360276|NON_INFERIORITY_OR_EQUIVALENCE|The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.||||||0.05|||||||t-test, 2 sided|||||||0.05
91732642|NCT00127439|183360276|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon rank sum test|||Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)||||0.05
91732643|NCT00127439|183360277|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
91732644|NCT00127439|183360278|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
91732645|NCT00127439|183360279|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
91732646|NCT00127439|183360280|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
91732647|NCT00127439|183360281|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
91732648|NCT00127439|183360282|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
91732649|NCT00127439|183360283|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
91732650|NCT00127439|183360284|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
91732651|NCT00376558|183360285|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
91732652|NCT00376558|183360286|SUPERIORITY_OR_OTHER||delta bpnd|-12.0|STANDARD_DEVIATION|7.0||0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.||||0.001
91528833|NCT01327547|182933701|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.92||||0.4196|TWO_SIDED|95.0|-1.33|3.17|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||3.17|-1.33|0.4196
91528834|NCT01327547|182933702|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.3||||0.9904|TWO_SIDED|95.0|-48.66|49.26||Not specifed.|ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||49.26|-48.66|0.9904
91528835|NCT01327547|182933702|SUPERIORITY_OR_OTHER||Difference in LS Mean|10.87||||0.7697|TWO_SIDED|95.0|-62.44|84.18|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||84.18|-62.44|0.7697
91528836|NCT01327547|182933702|SUPERIORITY_OR_OTHER||Difference in LS Mean|-24.49||||0.5816|TWO_SIDED|95.0|-112.21|63.23|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||63.23|-112.21|0.5816
91528837|NCT01327547|182933703|SUPERIORITY_OR_OTHER||Difference in LS Mean|498.04||||0.3786|TWO_SIDED|95.0|-617.33|1613.41|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1613.41|-617.33|0.3786
91528838|NCT01327547|182933703|SUPERIORITY_OR_OTHER||Difference in LS Mean|348.7||||0.4388|TWO_SIDED|95.0|-539.61|1237.01|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1237.01|-539.61|0.4388
91528839|NCT01327547|182933703|SUPERIORITY_OR_OTHER||Difference in LS Mean|-173.57||||0.8559|TWO_SIDED|95.0|-2060.81|1713.68|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1713.68|-2060.81|0.8559
91528840|NCT01327547|182933704|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.03||||0.8024|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.28|-0.22|0.8024
91528841|NCT01327547|182933704|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.266|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.43|-0.12|0.2660
91528842|NCT01327547|182933704|SUPERIORITY_OR_OTHER||Difference in LS mean|0.15||||0.2855|TWO_SIDED|95.0|-0.12|0.41|||ANCOVA||Difference in LS mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.41|-0.12|0.2855
91528843|NCT01327547|182933705|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.7778|TWO_SIDED|95.0|-0.93|1.23|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.23|-0.93|0.7778
91528844|NCT01327547|182933705|SUPERIORITY_OR_OTHER||Difference in LS mean|0.0||||0.9991|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.10|-0.10|0.9991
91528845|NCT01327547|182933705|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.02||||0.7275|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.11|-0.16|0.7275
91528846|NCT01327547|182933706|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.07||||0.5201|TWO_SIDED|95.0|-0.15|0.3|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.30|-0.15|0.5201
91528847|NCT01327547|182933706|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.08||||0.4657|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|||Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.13|-0.28|0.4657
91528848|NCT01327547|182933706|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.03||||0.8087|TWO_SIDED|95.0|-0.25|0.2|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.20|-0.25|0.8087
91528849|NCT01327547|182933707|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.84||||0.1417|TWO_SIDED|95.0|-4.31|0.63|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.63|-4.31|0.1417
91732653|NCT04620668|183360326|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
91732654|NCT04620668|183360326|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
91494257|NCT00518986|182860273|SUPERIORITY_OR_OTHER|||||||0.1627||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1627
91494258|NCT00518986|182860274|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0018
91732655|NCT04620668|183360326|SUPERIORITY|||||||0.044|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.044
91732656|NCT04620668|183360326|SUPERIORITY|||||||0.001|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.001
91732657|NCT04620668|183360326|SUPERIORITY|||||||0.731|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.731
91732658|NCT04620668|183360327|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
91732659|NCT04620668|183360327|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
91732660|NCT04620668|183360327|SUPERIORITY|||||||0.05|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.05
91732661|NCT04620668|183360327|SUPERIORITY|||||||0.024|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.024
91732662|NCT04620668|183360327|SUPERIORITY|||||||0.674|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.674
91732663|NCT04620668|183360328|SUPERIORITY|||||||0.159|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.159
91732664|NCT04620668|183360329|SUPERIORITY|||||||0.326|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.326
91732665|NCT04047355|183360332|SUPERIORITY||Median Difference (Final Values)|3.0||||0.12|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.12
91732666|NCT04047355|183360332|SUPERIORITY||Effect size (r)|-0.64|||||TWO_SIDED|||||||||||||
91732667|NCT04047355|183360332|SUPERIORITY||Post-hoc power analysis|0.39|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
91732668|NCT04047355|183360333|SUPERIORITY||Median Difference (Final Values)|2.0||||0.07|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.07
91732669|NCT04047355|183360333|SUPERIORITY||Effect size (r)|-0.74|||||TWO_SIDED|||||||||||||
91732670|NCT04047355|183360333|SUPERIORITY||Post-hoc power analysis|0.59|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
91732671|NCT00427700|183360336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.0||||0.3|TWO_SIDED|95.0|-9.0|33.0|||Fisher Exact|||The null hypothesis is that there is no significant difference between two drugs for ovulation induction.A sample size of 40 women per arm was calculated for this superiority trial, considering an alpha and beta error of 0.05 and 0.2, respectively, to find an absolute difference of 30% in the ovulation rate between groups, based on a previous study published by Mitwally and Casper (18) where the ovulation rate with CC was approximately 45%.||33|-9|0.3
91732672|NCT00427700|183360337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.2|TWO_SIDED|95.0|-6.0|34.0|||t-test, 2 sided|||Null hypothesis: There is no difference between the mean values of progesterone between both groups.||34|-6|0.2
91732673|NCT05081843|183360368|SUPERIORITY||Mean Difference (Final Values)|0.233||||0.05|TWO_SIDED|95.0|-0.056|0.522|||t-test, 2 sided|||||0.522|-0.056|0.05
91494259|NCT00518986|182860275|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
91732674|NCT05081843|183360369|SUPERIORITY||Median Difference (Final Values)|0.534||||0.05|TWO_SIDED|95.0|0.078|0.99|||t-test, 2 sided|||||0.990|0.078|0.05
91732675|NCT05081843|183360370|SUPERIORITY||Mean Difference (Final Values)|0.326||||0.05|TWO_SIDED|95.0|-0.177|0.829|||t-test, 2 sided|||||0.829|-0.177|0.05
91732676|NCT05081843|183360371|SUPERIORITY||Mean Difference (Final Values)|0.756||||0.05|TWO_SIDED|95.0|0.208|1.31|||t-test, 2 sided|||||1.31|0.208|0.05
91732677|NCT00835354|183360385|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|89.2||||||90.0|86.2|92.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.2|86.2|
91732678|NCT00835354|183360386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.5||||||90.0|88.9|92.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.1|88.9|
91759193|NCT02726022|183411388|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.052
91494260|NCT00518986|182860276|SUPERIORITY_OR_OTHER|||||||0.0126||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0126
91494261|NCT01930123|182860341|OTHER||Mean Difference (Final Values)|6.26|STANDARD_DEVIATION|9.98||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.01
91494262|NCT01930123|182860342|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Mild fibrosis vs. advanced fibrosis||||0.006
91494263|NCT01930123|182860343|OTHER||Median Difference (Final Values)|56.7|STANDARD_DEVIATION|2.6||0.09|TWO_SIDED||||||t-test, 1 sided|||||||0.09
91494264|NCT02899793|182860344|SUPERIORITY|||||||0.024|||||||Fisher Exact|||Subgroup difference in ORRs||||0.024
91494265|NCT00729651|182860352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.0|0.08|||Cochran-Mantel-Haenszel|Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.08|0.00|<0.0001
91494266|NCT00729651|182860353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091||95.0|||||ANCOVA|Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.||||||0.0091
91494267|NCT00729651|182860354|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.01|0.04|||Cochran-Mantel-Haenszel|It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.04|0.01|<0.0001
91494268|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-65.5||||0.0275|TWO_SIDED|95.0|-78.0|-58.0|||2-sided Wilcoxon Rank Sum|||||-58.00|-78.00|0.0275
91494269|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-61.0||||0.025|TWO_SIDED|95.0|-65.0|-44.0|||2-sided Wilcoxon Rank Sum|||||-44.00|-65.00|0.025
91494270|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-32.5||||0.0136|TWO_SIDED|95.0|-47.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-47.00|0.0136
91494271|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-36.5||||0.0136|TWO_SIDED|95.0|-62.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-62.00|0.0136
91494272|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-59.0||||0.025|TWO_SIDED|95.0|-70.0|-38.0|||2-sided Wilcoxon Rank Sum|||||-38.00|-70.00|0.025
91494273|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-66.0||||0.0119|TWO_SIDED|95.0|-68.0|-61.0|||2-sided Wilcoxon Rank Sum|||||-61.00|-68.00|0.0119
91494274|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-15.5||||0.2667|TWO_SIDED|95.0|-38.0|17.0|||2-sided Wilcoxon Rank Sum|||||17.00|-38.00|0.2667
91494275|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-68.0||||0.0238|TWO_SIDED|95.0|-74.0|-59.0|||2-sided Wilcoxon Rank Sum|||||-59.00|-74.00|0.0238
91494276|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-56.5||||0.0007|TWO_SIDED|95.0|-65.0|-39.0|||2-sided Wilcoxon Rank Sum|||||-39.00|-65.00|0.0007
91494277|NCT03310021|182860356|SUPERIORITY||Hodges lehman Location shift|-35.0||||0.0121|TWO_SIDED|95.0|-53.0|-24.0|||2-sided Wilcoxon Rank Sum|||||-24.00|-53.00|0.0121
91494278|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-80.0||||0.0256|TWO_SIDED|95.0|-83.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-83.00|0.0256
91494279|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-79.5||||0.025|TWO_SIDED|95.0|-97.0|-67.0|||2-sided Wilcoxon Rank Sum|||||-67.00|-97.00|0.025
91494280|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-37.0||||0.074|TWO_SIDED|95.0|-66.0|5.0|||2-sided Wilcoxon Rank Sum|||||5.00|-66.00|0.074
91494281|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-10.5||||0.1066|TWO_SIDED|95.0|-59.0|10.0|||2-sided Wilcoxon Rank Sum|||||10.00|-59.00|0.1066
91494282|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0219|TWO_SIDED|95.0|-87.0|-71.0|||2-sided Wilcoxon Rank Sum|||||-71.00|-87.00|0.0219
91494283|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-78.0||||0.0262|TWO_SIDED|95.0|-83.0|-74.0|||2-sided Wilcoxon Rank Sum|||||-74.0|-83.00|0.0262
91494284|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-50.0||||0.0412|TWO_SIDED|95.0|-65.0|0.0|||2-sided Wilcoxon Rank Sum|||||0.00|-65.00|0.0412
91494285|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-89.5||||0.0269|TWO_SIDED|95.0|-93.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-93.00|0.0269
91494286|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0026|TWO_SIDED|95.0|-86.0|-69.0|||2-sided Wilcoxon Rank Sum|||||-69.00|-86.00|0.0026
91494287|NCT03310021|182860357|SUPERIORITY||Hodges lehman Location shift|-65.0||||0.0181|TWO_SIDED|95.0|-76.0|-57.0|||2-sided Wilcoxon Rank Sum|||||-57.00|-76.00|0.0181
91494288|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-81.06||||0.0282|TWO_SIDED|95.0|-92.99|-71.96|||2-sided Wilcoxon Rank Sum|||||-71.96|-92.99|0.0282
91494289|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-69.15||||0.0282|TWO_SIDED|95.0|-96.91|-48.64|||2-sided Wilcoxon Rank Sum|||||-48.64|-96.91|0.0282
91494290|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-57.39||||0.0085|TWO_SIDED|95.0|-72.07|-40.03|||2-sided Wilcoxon Rank Sum|||||-40.03|-72.07|0.0085
91494291|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-54.96||||0.0085|TWO_SIDED|95.0|-80.42|-25.5|||2-sided Wilcoxon Rank Sum|||||-25.50|-80.42|0.0085
91494292|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-100.25||||0.0282|TWO_SIDED|95.0|-133.08|-84.48|||2-sided Wilcoxon Rank Sum|||||-84.48|-133.08|0.0282
91494293|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-79.87||||0.0282|TWO_SIDED|95.0|-86.36|-65.74|||2-sided Wilcoxon Rank Sum|||||-65.74|-86.36|0.0282
91494294|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-65.02||||0.0085|TWO_SIDED|95.0|-89.54|-39.17|||2-sided Wilcoxon Rank Sum|||||-39.17|-89.54|0.0085
91494295|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-91.29||||0.0282|TWO_SIDED|95.0|-128.88|-60.83|||2-sided Wilcoxon Rank Sum|||||-60.83|-128.88|0.0282
91494296|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-81.49||||0.0034|TWO_SIDED|95.0|-91.05|-65.96|||2-sided Wilcoxon Rank Sum|||||-65.96|-91.05|0.0034
91494297|NCT03310021|182860358|SUPERIORITY||Hodges lehman Location shift|-58.47||||0.0189|TWO_SIDED|95.0|-110.86|-46.12|||2-sided Wilcoxon Rank Sum|||||-46.12|-110.86|0.0189
91494298|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-59.39||||0.0282|TWO_SIDED|95.0|-66.48|-52.62|||2-sided Wilcoxon Rank Sum|||||-52.62|-66.48|0.0282
91494299|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-59.26||||0.0282|TWO_SIDED|95.0|-70.34|-26.94|||2-sided Wilcoxon Rank Sum|||||-26.94|-70.34|0.0282
91494300|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-36.76||||0.0085|TWO_SIDED|95.0|-46.14|-29.76|||2-sided Wilcoxon Rank Sum|||||-29.76|-46.14|0.0085
91494301|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-36.82||||0.0085|TWO_SIDED|95.0|-55.81|-20.46|||2-sided Wilcoxon Rank Sum|||||-20.46|-55.81|0.0085
91494302|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-61.67||||0.0282|TWO_SIDED|95.0|-75.82|-43.78|||2-sided Wilcoxon Rank Sum|||||-43.78|-75.82|0.0282
91494303|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-67.63||||0.0282|TWO_SIDED|95.0|-77.4|-61.99|||2-sided Wilcoxon Rank Sum|||||-61.99|-77.40|0.0282
91494304|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-40.33||||0.0085|TWO_SIDED|95.0|-59.77|-11.17|||2-sided Wilcoxon Rank Sum|||||-11.17|-59.77|0.0085
91494305|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-59.18||||0.0282|TWO_SIDED|95.0|-101.02|-48.14|||2-sided Wilcoxon Rank Sum|||||-48.14|-101.02|0.0282
91494306|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-54.63||||0.0027|TWO_SIDED|95.0|-59.14|-41.19|||2-sided Wilcoxon Rank Sum|||||-41.19|-59.14|0.0027
91494307|NCT03310021|182860359|SUPERIORITY||Hodges lehman Location shift|-38.14||||0.0189|TWO_SIDED|95.0|-65.78|-15.37|||2-sided Wilcoxon Rank Sum|||||-15.37|-65.78|0.0189
91732679|NCT00835354|183360387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.7||||||90.0|89.1|92.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.3|89.1|
91494308|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|965.09||||0.0282|TWO_SIDED|95.0|474.48|1377.35|||2-sided Wilcoxon Rank Sum|||||1377.35|474.48|0.0282
91494309|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|1127.29||||0.0282|TWO_SIDED|95.0|769.46|1575.02|||2-sided Wilcoxon Rank Sum|||||1575.02|769.46|0.0282
91494310|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|574.89||||0.0085|TWO_SIDED|95.0|307.65|1175.28|||2-sided Wilcoxon Rank Sum|||||1175.28|307.65|0.0085
91528850|NCT01327547|182933707|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.44||||0.2679|TWO_SIDED|95.0|-4.01|1.14|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.14|-4.01|0.2679
91528851|NCT01327547|182933707|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.48||||0.1366|TWO_SIDED|95.0|-3.45|0.49|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.49|-3.45|0.1366
91759194|NCT02726022|183411388|SUPERIORITY_OR_OTHER|||||||0.677|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.677
91494311|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|715.34||||0.0085|TWO_SIDED|95.0|535.38|836.4|||2-sided Wilcoxon Rank Sum|||||836.40|535.38|0.0085
91494312|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|1141.17||||0.0282|TWO_SIDED|95.0|964.03|1736.78|||2-sided Wilcoxon Rank Sum|||||1736.78|964.03|0.0282
91494313|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|1198.83||||0.0282|TWO_SIDED|95.0|988.82|1670.3|||2-sided Wilcoxon Rank Sum|||||1670.30|988.82|0.0282
91494314|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|721.21||||0.0085|TWO_SIDED|95.0|585.92|1108.92|||2-sided Wilcoxon Rank Sum|||||1108.92|585.92|0.0085
91494315|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|1204.62||||0.0282|TWO_SIDED|95.0|1001.72|1471.45|||2-sided Wilcoxon Rank Sum|||||1471.45|1001.72|0.0282
91494316|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|1180.5||||0.0027|TWO_SIDED|95.0|857.21|1296.02|||2-sided Wilcoxon Rank Sum|||||1296.02|857.21|0.0027
91494317|NCT03310021|182860360|SUPERIORITY||Hodges lehman Location shift|976.59||||0.0189|TWO_SIDED|95.0|585.99|1498.37|||2-sided Wilcoxon Rank Sum|||||1498.37|585.99|0.0189
91494318|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|826.9||||0.0282|TWO_SIDED|95.0|505.4|1362.11|||2-sided Wilcoxon Rank Sum|||||1362.11|505.40|0.0282
91494319|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|1125.7||||0.0282|TWO_SIDED|95.0|873.87|1552.77|||2-sided Wilcoxon Rank Sum|||||1552.77|873.87|0.0282
91494320|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|538.84||||0.0085|TWO_SIDED|95.0|291.2|1077.46|||2-sided Wilcoxon Rank Sum|||||1077.46|291.20|0.0085
91494321|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|687.57||||0.0085|TWO_SIDED|95.0|500.92|902.73|||2-sided Wilcoxon Rank Sum|||||902.73|500.92|0.0085
91494322|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|1012.45||||0.0282|TWO_SIDED|95.0|859.08|1352.05|||2-sided Wilcoxon Rank Sum|||||1352.05|859.08|0.0282
91494323|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|1057.27||||0.0282|TWO_SIDED|95.0|818.96|1634.3|||2-sided Wilcoxon Rank Sum|||||1634.30|818.96|0.0282
91759195|NCT02726022|183411389|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.720
91494324|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|630.81||||0.0085|TWO_SIDED|95.0|421.78|1124.28|||2-sided Wilcoxon Rank Sum|||||1124.28|421.78|0.0085
91494325|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|925.84||||0.0282|TWO_SIDED|95.0|663.74|1216.28|||2-sided Wilcoxon Rank Sum|||||1216.28|663.74|0.0282
91494326|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|871.11||||0.0027|TWO_SIDED|95.0|631.67|1051.06|||2-sided Wilcoxon Rank Sum|||||1051.06|631.67|0.0027
91494327|NCT03310021|182860361|SUPERIORITY||Hodges lehman Location shift|874.44||||0.0189|TWO_SIDED|95.0|637.25|1412.21|||2-sided Wilcoxon Rank Sum|||||1412.21|637.25|0.0189
91494328|NCT01049308|182860428|SUPERIORITY_OR_OTHER||percentage|57.6|||||TWO_SIDED|||||||||Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure||||
91732680|NCT05472870|183360394|SUPERIORITY|One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS. A P value \<0.05 was considered statistically significant for all analyses.|||||<|0.001||||||Bonferroni correction was used to adjust P values in post hoc analyses.|ANOVA|||All clinical behavioral data analysis was performed using Statistical Product and Service Solutions (SPSS) software (version 25.0). A P value \<0.05 was considered statistically significant for all analyses. One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS.||||<0.001
91732681|NCT01385995|183360404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.57|TWO_SIDED|95.0|0.52|3.24|||Generalized Estimating Equation|Controlled for period and baseline 2 hour OGTT glucose level.||Based on an intent to treat approach a Generalized Estimating Equation (GEE) was used to estimate the effect of therapy (CPAP or Sham) on the odds of normalization of Impaired Glucose Tolerance (IGT). This model provides an estimate of the odds ratio of normalizing the 2-hour oral glucose tolerance test (OGTT) with CPAP compared with Sham-CPAP.||3.24|0.52|0.57
91732682|NCT01385995|183360405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.38|TWO_SIDED|95.0|-1.2|3.0|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP.||3.0|-1.2|0.38
91732683|NCT01385995|183360405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.11|TWO_SIDED|95.0|-16.3|1.7|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham.||1.7|-16.3|0.11
91732684|NCT01385995|183360405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.86|TWO_SIDED|95.0|-3.3|2.7|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25.||2.7|-3.3|0.86
91732685|NCT01385995|183360405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6||||0.08|TWO_SIDED|95.0|-24.6|1.3|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25.||1.3|-24.6|0.08
91732686|NCT01385995|183360406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.14|TWO_SIDED|95.0|-3.4|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, fasting insulin, between CPAP and sham-CPAP.||0.5|-3.4|0.14
91759196|NCT02726022|183411389|SUPERIORITY_OR_OTHER|||||||0.237|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.237
91759197|NCT02726022|183411390|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.184
91759198|NCT02726022|183411390|SUPERIORITY_OR_OTHER|||||||0.889|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.889
91759199|NCT01124955|183411397|SUPERIORITY_OR_OTHER||||||,|0|||||||ANOVA|||||||0,05
91494329|NCT03396367|182860461|SUPERIORITY||Slope|0.372||||0.433|TWO_SIDED|95.0|-0.558|1.302||Condition (referent = education control).|Latent Growth Curve||Variable:|||1.302|-.558|.433
91494330|NCT03396367|182860461|SUPERIORITY||Slope|-0.017||||0.749|TWO_SIDED|95.0|-0.121|0.087|||Latent Growth Curve||Variable: Communication Compentence|||.087|-.121|.749
91494331|NCT03396367|182860461|SUPERIORITY||Slope|0.073||||0.302|TWO_SIDED|95.0|-0.121|0.087|||Latent Growth Curve||Moderating Variable: Communication Competence by Condition|||.087|-.121|.302
91494332|NCT03396367|182860461|SUPERIORITY||Slope|0.027||||0.799|TWO_SIDED|95.0|-0.182|0.236|||Latent Growth Curve||Variable: Relationship Satisfaction|||.236|-.182|.799
91494333|NCT03396367|182860461|SUPERIORITY||Slope|-0.211||||0.173|TWO_SIDED|95.0|-0.514|0.092|||Latent Growth Curve||Moderating Variable: Relationship Satisfaction by Condition|||.092|-.514|.173
91494334|NCT03396367|182860462|SUPERIORITY||Slope|0.427||||0.172|TWO_SIDED|95.0|-0.186|1.04||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at baseline.|Latent Growth Curve|||||1.04|-.186|.172
91494335|NCT03396367|182860462|SUPERIORITY||Slope|-0.281||||0.054|TWO_SIDED|95.0|-0.623|0.061||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at the 3-month follow-up.|Latent Growth Curve|||||.061|-.623|.054
91494336|NCT03396367|182860462|SUPERIORITY||Slope|0.125||||0.036|TWO_SIDED|95.0|-0.011|0.26||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention across the 3-,6-,9-, and 12- month follow-ups.|Latent Growth Curve|||||.260|-.011|.036
91494337|NCT03396367|182860463|SUPERIORITY||Slope|0.245||||0.679|TWO_SIDED|95.0|-0.913|1.403||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at baseline.|Latent Growth Curve|||||1.403|-.913|.679
91494338|NCT03396367|182860463|SUPERIORITY||Slope|-0.301||||0.359|TWO_SIDED|95.0|-1.938|1.336||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at the 3-month follow-up.|Latent Growth Curve|||||1.336|-1.938|.359
91494339|NCT03396367|182860463|SUPERIORITY||Slope|0.048||||0.431|TWO_SIDED|95.0|-0.496|0.593||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention across the 3-,6-,9-, and 12- month follow-ups.|Latent Growth Curve|||||.593|-.496|.431
91732687|NCT01385995|183360406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.12|TWO_SIDED|95.0|-23.3|2.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP.||2.8|-23.3|0.12
91732688|NCT01385995|183360406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1|TWO_SIDED|95.0|-5.2|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||0.5|-5.2|0.10
91732689|NCT01385995|183360406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.7||||0.002|TWO_SIDED|95.0|-46.5|-10.9|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||-10.9|-46.5|0.002
91732690|NCT01385995|183360407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.18|TWO_SIDED|95.0|-17.6|3.8|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP.||3.8|-17.6|0.18
91732691|NCT01385995|183360407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.08|TWO_SIDED|95.0|-27.5|1.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||1.8|-27.5|0.08
91732692|NCT01385995|183360408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.2|TWO_SIDED|95.0|-2.0|9.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensivity Index, between CPAP and sham-CPAP.||9.8|-2.0|0.20
91732693|NCT01385995|183360408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.3||||0.002|TWO_SIDED|95.0|5.2|22.1|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||22.1|5.2|0.002
91732694|NCT02414841|183360409|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.932|TWO_SIDED|95.0|0.67|1.39|||Log Rank|Weighted|Performed as sensitivity analysis|||1.39|0.67|0.932
91732695|NCT02414841|183360410|SUPERIORITY|||||||0.328|||||||Chi-squared|||||||0.328
91732696|NCT05339659|183360445|OTHER|The point null hypothesis of the significance test was a difference in expected number of log ins of 0.|Mean Difference (Final Values)|3.55||||0.219|TWO_SIDED|95.0|-2.33|9.44|||Regression, Linear||mean difference=experimental-control|A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.||9.44|-2.33|0.219
91732697|NCT05339659|183360447|OTHER|The null hypothesis for the significance test is 0 difference in average number of days of use between arms.|Mean Difference (Final Values)|-22.12||||0.153|TWO_SIDED|95.0|-53.44|9.19|||Regression, Linear||mean difference=experimental-control|||9.19|-53.44|0.153
91732698|NCT05339659|183360448|OTHER|The null hypothesis for the significance test is a relative difference=0.|Risk Difference (RD)|0.095||||0.727|TWO_SIDED|95.0|-0.352|0.558|||Barnard's exact test||risk difference=experimental-control|||0.558|-0.352|0.727
91732699|NCT05339659|183360449|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.6|1.61|||Regression, Linear||mean difference=experimental-control|||1.61|-0.60|0.325
91732700|NCT05339659|183360450|OTHER|The null hypothesis of the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.22||||0.745|TWO_SIDED|95.0|-1.28|1.72|||Regression, Linear||mean difference=experimental-control|||1.72|-1.28|0.745
91732701|NCT05339659|183360451|OTHER|The null hypothesis of the significance test is a risk difference=0.|Risk Difference (RD)|0.58||||0.009|TWO_SIDED|95.0|0.16|0.85|||Barnard's exact test||risk difference=experimental-control|||0.85|0.16|0.009
91494340|NCT03396367|182860464|SUPERIORITY||Slope|-1.251||||0.326|TWO_SIDED|95.0|-3.814|1.311||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at baseline.|Latent Growth Curve|||||1.311|-3.814|.326
91494341|NCT03396367|182860464|SUPERIORITY||Slope|0.246||||0.384|TWO_SIDED|95.0|-1.383|1.875||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention at the 3-month follow-up.|Latent Growth Curve|||||1.875|-1.383|.384
91494342|NCT03396367|182860464|SUPERIORITY||Slope|0.856||||0.019|TWO_SIDED|95.0|0.052|1.659||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between the Partner intervention and the Education intervention across the 3-,6-,9-, and 12- month follow-ups.|Latent Growth Curve|||||1.659|.052|.019
91494343|NCT01411774|182860467|SUPERIORITY|||||||0.95||||||p \< .05 was the threshold of significance.|Mixed Models Analysis|Analysis for the outcomes used linear mixed-effects models, with treatment group as the between-participant factor and time as the within group factor||||||.95
91494344|NCT03292588|182860483|SUPERIORITY|Negative binomial model for the rate of exacerbations in the first year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.73||||0.027|TWO_SIDED|95.0|0.56|0.96|||Regression, Negative Binomial|Adjusted relative rate of exacerbations in the first year.||||0.96|0.56|0.027
91494345|NCT03292588|182860484|SUPERIORITY||Least Square Mean Difference|-0.28||||0.29|TWO_SIDED|95.0|-0.81|0.24|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 12.||Week 12||0.24|-0.81|0.290
91494346|NCT03292588|182860484|SUPERIORITY||Least Square Mean Difference|-0.07||||0.82|TWO_SIDED|95.0|-0.69|0.55|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 24.||Week 24||0.55|-0.69|0.820
91494347|NCT03292588|182860484|SUPERIORITY||Least Square Mean Difference|-0.51||||0.096|TWO_SIDED|95.0|-1.11|0.09|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 36.||Week 36||0.09|-1.11|0.096
91494348|NCT03292588|182860484|SUPERIORITY||Least Square Mean Difference|-0.06||||0.831|TWO_SIDED|95.0|-0.65|0.52|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 48.||Week 48||0.52|-0.65|0.831
91494349|NCT03292588|182860484|SUPERIORITY||Least Square Mean Difference|0.02||||0.947|TWO_SIDED|95.0|-0.6|0.64|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 52.||Week 52||0.64|-0.60|0.947
91528852|NCT00900627|182933719|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|40.0|||||||||||||Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.|A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where \>25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.||||
91528853|NCT00900627|182933720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.679|TWO_SIDED|95.0|0.76|1.52||Statistical significance threshold at this analysis was 5%|Cox Proportional Hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||1.52|0.76|0.679
91494350|NCT03292588|182860485|SUPERIORITY|A generalized logit model was used to analyze Physician Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as primary exposure but was also adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.62|1.64|||Regression, Logistic|||Physician Global Assessment Tool||1.64|0.62|0.974
91494351|NCT03292588|182860486|SUPERIORITY|A generalized logit model was used to analyze the Patient Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as the primary exposure but was adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|0.72||||0.238|TWO_SIDED|95.0|0.42|1.24|||Regression, Logistic|||Patient Global Assessment Tool||1.24|0.42|0.238
91494352|NCT03292588|182860487|SUPERIORITY|A generalized mixed model as described in section 8.3.1 was used to analyze each spirometry and impulse oscillometry parameter, separately, at each visit where the lung function was collected.|Least Square Mean Difference|-0.005||||0.591|TWO_SIDED|95.0|-0.023|0.013|||Mixed Models Analysis|||FEV1/FVC Week 12||0.013|-0.023|0.591
91494353|NCT03292588|182860487|SUPERIORITY||Least Square Mean Difference|-0.011||||0.265|TWO_SIDED|95.0|-0.031|0.008|||Mixed Models Analysis|||FEV1/FVC Week 24||0.008|-0.031|0.265
91702217|NCT00778102|183299407|SUPERIORITY_OR_OTHER||Difference in Response Rate|-4.8||||0.7817|TWO_SIDED|95.0|-43.0|33.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with complete or major histopathological response.||33.5|-43.0|0.7817
91494354|NCT03292588|182860487|SUPERIORITY||Least Square Mean Difference|0.011||||0.345|TWO_SIDED|95.0|-0.012|0.033|||Mixed Models Analysis|||FEV1/FVC Week 36||0.033|-0.012|0.345
91494355|NCT03292588|182860487|SUPERIORITY||Least Square Mean Difference|0.013||||0.248|TWO_SIDED|95.0|-0.009|0.036|||Mixed Models Analysis|||FEV1/FVC Week 48||0.036|-0.009|0.248
91732702|NCT05339659|183360454|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|1.39||||0.469|TWO_SIDED|95.0|-2.66|5.44|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||5.44|-2.66|0.469
91732703|NCT05339659|183360455|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|-0.66||||0.614|TWO_SIDED|95.0|-3.48|2.16|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||2.16|-3.48|0.614
91732704|NCT05339659|183360456|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.14||||0.9|TWO_SIDED|95.0|-2.67|2.38|||Regression, Linear||mean difference=experimental-control|||2.38|-2.67|0.90
91732705|NCT05339659|183360457|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.55||||0.632|TWO_SIDED|95.0|-3.03|1.93|||Regression, Linear||mean difference=experimental-control|||1.93|-3.03|0.632
91732706|NCT05339659|183360458|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.31||||0.227|TWO_SIDED|95.0|-3.55|-0.94|||Regression, Linear||mean difference=experimental-control|||-0.94|-3.55|0.227
91732707|NCT05339659|183360459|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.22||||0.274|TWO_SIDED|95.0|-3.58|1.15|||Regression, Linear||mean difference=experimental-control|||1.15|-3.58|0.274
91528854|NCT00900627|182933721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.026|TWO_SIDED|95.0|1.09|3.75||Statistical significance threshold at this analysis was 5%|Logistic Regression|Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||3.75|1.09|0.026
91528855|NCT00900627|182933722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.607|TWO_SIDED|95.0|0.67|2.01||Statistical significance threshold at this analysis was 5%|Cox proportional hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||2.01|0.67|0.607
91528856|NCT01474512|182933738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528857|NCT01474512|182933738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528858|NCT01474512|182933739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528859|NCT01474512|182933739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528860|NCT01474512|182933740|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
91528861|NCT01474512|182933740|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
91528862|NCT01474512|182933741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528863|NCT01474512|182933741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528864|NCT01474512|182933741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
91732708|NCT05339659|183360463|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
91732709|NCT05339659|183360464|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.01||||0.845|TWO_SIDED|95.0|-0.49|0.43|||Barnard's exact test||risk difference=experimental-control|||0.43|-0.49|0.845
91732710|NCT05339659|183360465|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.05||||0.56|TWO_SIDED|95.0|-0.47|0.28|||Barnard's exact test||||risk difference=experimental-control|0.28|-0.47|0.560
91732711|NCT05339659|183360466|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
91732712|NCT05339659|183360467|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.13||||0.632|TWO_SIDED|95.0|-0.49|0.34|||Barnard's exact test||risk difference=experimental-control|||0.34|-0.49|0.632
91494356|NCT03292588|182860487|SUPERIORITY||Least Square Mean Difference|-0.002||||0.864|TWO_SIDED|95.0|-0.023|0.02|||Mixed Models Analysis|||FEV1/FVC Week 52||0.020|-0.023|0.864
91528865|NCT01474512|182933741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
91494357|NCT03292588|182860488|SUPERIORITY||Least Square Mean Difference|-0.4||||0.816|TWO_SIDED|95.0|-3.8|3.0|||Mixed Models Analysis|||FEV1PP Week 12||3.0|-3.8|0.816
91494358|NCT03292588|182860488|SUPERIORITY||Least Square Mean Difference|-3.4||||0.095|TWO_SIDED|95.0|-7.4|0.6|||Mixed Models Analysis|||FEV1PP Week 24||0.6|-7.4|0.095
91528866|NCT01474512|182933742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
91494359|NCT03292588|182860488|SUPERIORITY||Least Square Mean Difference|1.5||||0.444|TWO_SIDED|95.0|-2.4|5.5|||Mixed Models Analysis|||FEV1PP Week 36||5.5|-2.4|0.444
91494360|NCT03292588|182860488|SUPERIORITY||Least Square Mean Difference|0.6||||0.751|TWO_SIDED|95.0|-3.3|4.6|||Mixed Models Analysis|||FEV1PP Week 48||4.6|-3.3|0.751
91494361|NCT03292588|182860488|SUPERIORITY||Least Square Mean Difference|-2.6||||0.184|TWO_SIDED|95.0|-6.5|1.3|||Mixed Models Analysis|||FEV1PP Week 52||1.3|-6.5|0.184
91528867|NCT01474512|182933742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
91759200|NCT03274518|183411401|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.4534|||||||t-test, 2 sided|||||||0.4534
91759201|NCT03274518|183411402|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.1179|||||||t-test, 2 sided|||||||0.1179
91759202|NCT03274518|183411403|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.3054|||||||t-test, 2 sided|||||||0.3054
91759203|NCT03274518|183411404|NON_INFERIORITY|The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)||||||0.045|||||||t-test, 2 sided|||||||0.045
91759204|NCT00781859|183411406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.003|TWO_SIDED|95.0|1.32|5.24||comparing placebo and ocriplasmin|Fisher Exact|||||5.24|1.32|0.003
91759205|NCT01220180|183411425|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759206|NCT01220180|183411426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759207|NCT01220180|183411427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759208|NCT01220180|183411428|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759209|NCT01220180|183411429|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759210|NCT01220180|183411430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759211|NCT01220180|183411431|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759212|NCT01220180|183411432|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91759213|NCT00348309|183411449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.049|TWO_SIDED|95.0|-2.7|0.0||APOE4 negatives|Mixed Models Analysis|||||-0.0|-2.7|0.049
91759214|NCT00348309|183411449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.808|TWO_SIDED|95.0|-1.7|1.3||APOE4 negatives|Mixed Models Analysis|||||1.3|-1.7|0.808
91759215|NCT00348309|183411449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.035|TWO_SIDED|95.0|-1.9|-0.1||All except E4/E4s|Mixed Models Analysis|||||-0.1|-1.9|0.035
91759216|NCT00348309|183411449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.999|TWO_SIDED|95.0|-1.0|1.0||All except E4/E4s|Mixed Models Analysis|||||1.0|-1.0|0.999
91759217|NCT00348309|183411449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-1.9|0.020
91759218|NCT00348309|183411449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.661|TWO_SIDED|95.0|-1.2|0.7||Full population|Mixed Models Analysis|||||0.7|-1.2|0.661
91759219|NCT00348309|183411450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.056|TWO_SIDED|95.0|-1.0|0.0||APOE4 negatives|Mixed Models Analysis|||||0.0|-1.0|=0.056
91759220|NCT00348309|183411450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.587|TWO_SIDED|95.0|-0.4|0.7||APOE4 negatives|Mixed Models Analysis|||||0.7|-0.4|=0.587
91759221|NCT00348309|183411450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.004|TWO_SIDED|95.0|-0.9|-0.2||All except E4/E4s|Mixed Models Analysis|||||-0.2|-0.9|=0.004
91759222|NCT00348309|183411450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.402|TWO_SIDED|95.0|-0.2|0.6||All except E4/E4s|Mixed Models Analysis|||||0.6|-0.2|=0.402
91759223|NCT00348309|183411450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.002|TWO_SIDED|95.0|-0.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-0.9|=0.002
91759224|NCT00348309|183411450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||=|0.478|TWO_SIDED|95.0|-0.2|0.5||Full population|Mixed Models Analysis|||||0.5|-0.2|=0.478
91759225|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||=|0.34|TWO_SIDED|95.0|-2.0|0.7||Week 8|Mixed Models Analysis|||||0.7|-2.0|=0.340
91759226|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.079|TWO_SIDED|95.0|-2.5|0.1||Week 8|Mixed Models Analysis|||||0.1|-2.5|=0.079
91759227|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.91|TWO_SIDED|95.0|-1.7|1.5||Week 16|Mixed Models Analysis|||||1.5|-1.7|=0.910
91759228|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.521|TWO_SIDED|95.0|-2.1|1.0||Week 16|Mixed Models Analysis|||||1.0|-2.1|0.521
91759229|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||=|0.154|TWO_SIDED|95.0|-0.5|3.0||Week 24|Mixed Models Analysis|||||3.0|-0.5|=0.154
91759230|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.836|TWO_SIDED|95.0|-1.6|2.0||Week 24|Mixed Models Analysis|||||2.0|-1.6|=0.836
91759231|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.061|TWO_SIDED|95.0|-0.1|4.2||Week 48|Mixed Models Analysis|||||4.2|-0.1|0.061
91528868|NCT01474512|182933743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91732713|NCT05339659|183360468|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.03|||>|0.999|TWO_SIDED|95.0|-0.48|0.45|||Barnard's exact test||risk difference=experimental-control|||0.45|-0.48|>0.999
91732714|NCT03360344|183360529|OTHER|non-parametric tests were used as data was not normally distributed.||||||0.48|||||||Wilcoxan signed Rank|||statistical analysis for wrist||||0.48
91732715|NCT03360344|183360529|OTHER|nonparametric test were used as the distribution was not normal.||||||0.99|||||||Wilcoxan Signed Rank|||statistical analysis for forearm||||.99
91732716|NCT03360344|183360530|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for forearm||||.001
91732717|NCT03360344|183360530|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for wrist||||.001
91732718|NCT03360344|183360531|OTHER|||||||0.06|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.06
91732719|NCT03360344|183360532|OTHER|||||||0.01|||||||ANCOVA|||||||.01
91732720|NCT03360344|183360533|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||.001
91732721|NCT01765400|183360552|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91732722|NCT01342666|183360556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1154|STANDARD_ERROR_OF_MEAN|0.9057|<|0.0001|TWO_SIDED|95.0|3.2925|6.9383||We did only one comparison. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||We compare de mean difference of the delta (final-basal levels) between groups. The values posted are the difference found in the tomato group in comparison of the control group. The mean represent the increment of HDL-c in the tomato group.|We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.||6.9383|3.2925|<0.0001
91732723|NCT01342666|183360556|SUPERIORITY_OR_OTHER||Slope|5.656|STANDARD_ERROR_OF_MEAN|0.789|<|0.0001|TWO_SIDED|95.0|4.027|7.232||A priori p value of \<0.05|Regression, Linear|Adjusted for adherence, smoking, age, gender, waist to hip ratio, triglycerides, body mass index, exercise, omega 3, alcohol, fish, simple sugars.|Parameters of the model: F= 4.06; r = 0.798; r2 = 0.638; p=0.001|||7.232|4.027|<0.0001
91732724|NCT00688740|183360561|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.795||||0.0043|TWO_SIDED|95.0|0.679|0.932||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.932|0.679|0.0043
91528869|NCT01474512|182933743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91732725|NCT00688740|183360562|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.742||||0.002|TWO_SIDED|95.0|0.613|0.898||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.898|0.613|0.0020
91732726|NCT00895921|183360582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.1139||0.042|TWO_SIDED|95.0|0.00943|0.47605||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||.47605|.00943|0.042
91732727|NCT00895921|183360583|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.253|STANDARD_ERROR_OF_MEAN|0.224||0.269|TWO_SIDED|95.0|-0.208|0.714||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||0.714|-0.208|0.269
91732728|NCT00895921|183360584|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.149||0.012|TWO_SIDED|95.0|0.095|0.705|||Chi-squared, Corrected|||Comparison of akathisia rates between the two arms.||.705|.095|0.012
91732729|NCT01905540|183360585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.244|||||TWO_SIDED|90.0|1.081|1.43||||||||1.430|1.081|
91732730|NCT01905540|183360586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Geometric LS Means|1.233|||||TWO_SIDED|90.0|1.07|1.422||||||||1.422|1.070|
91732731|NCT01905540|183360587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.344|||||TWO_SIDED|90.0|1.135|1.592||||||||1.592|1.135|
91732732|NCT04770285|183360596|SUPERIORITY||Treatment Difference|-1.78||||0.0568|TWO_SIDED|95.0|-3.6|0.05|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.05|-3.60|0.0568
91732733|NCT04770285|183360597|SUPERIORITY||Treatment Difference|-0.77||||0.0705|TWO_SIDED|95.0|-1.61|0.07|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.07|-1.61|0.0705
91528870|NCT01474512|182933744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528871|NCT01474512|182933744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528872|NCT01474512|182933745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528873|NCT01474512|182933745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528874|NCT01474512|182933746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528875|NCT01474512|182933746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528876|NCT01474512|182933747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528877|NCT01474512|182933747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528878|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for Absenteeism.||||||<0.001
91528879|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for absenteeism.||||||0.003
91528880|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
91528881|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
91528882|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
91528883|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
91528884|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
91528885|NCT01474512|182933748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
91528886|NCT01474512|182933749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
91528887|NCT01474512|182933749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
91528888|NCT01474512|182933750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
91528889|NCT01474512|182933750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
91732734|NCT04770285|183360598|SUPERIORITY||Treatment Difference|-0.62||||0.3687|TWO_SIDED|95.0|-1.99|0.74||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.74|-1.99|0.3687
91732735|NCT04770285|183360598|SUPERIORITY||Treatment Difference|-1.45||||0.0828|TWO_SIDED|95.0|-3.1|0.19||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.19|-3.10|0.0828
91528890|NCT01474512|182933750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
91732736|NCT04770285|183360599|SUPERIORITY||Treatment Difference|-0.34||||0.3549|TWO_SIDED|95.0|-1.06|0.38||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.38|-1.06|0.3549
91732737|NCT04770285|183360599|SUPERIORITY||Treatment Difference|-0.28||||0.4948|TWO_SIDED|95.0|-1.09|0.53||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.53|-1.09|0.4948
91732738|NCT04770285|183360600|SUPERIORITY||Ratio of Response Rate|1.68||||0.142|TWO_SIDED|95.0|0.84|3.34||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||3.34|0.84|0.1420
91732739|NCT04770285|183360600|SUPERIORITY||Ratio of Response Rate|1.31||||0.2939|TWO_SIDED|95.0|0.79|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||2.16|0.79|0.2939
91732740|NCT04770285|183360600|SUPERIORITY||Ratio of Response Rate|1.38||||0.0884|TWO_SIDED|95.0|0.96|1.99||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.99|0.96|0.0884
91732741|NCT04770285|183360601|SUPERIORITY||Treatment Difference|-0.19||||0.0039|TWO_SIDED|95.0|-0.32|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||-0.06|-0.32|0.0039
91732742|NCT04770285|183360601|SUPERIORITY||Treatment Difference|-0.32||||0.0003|TWO_SIDED|95.0|-0.5|-0.15||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.15|-0.50|0.0003
91732743|NCT04770285|183360601|SUPERIORITY||Treatment Difference|-0.26||||0.0098|TWO_SIDED|95.0|-0.46|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.06|-0.46|0.0098
91732744|NCT04770285|183360602|SUPERIORITY||Treatment Difference|-1.02||||0.4463|TWO_SIDED|95.0|-3.66|1.61||p-value was calculated by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|ANCOVA|||||1.61|-3.66|0.4463
91732745|NCT04770285|183360603|SUPERIORITY||Treatment Difference|-1.29||||0.0102|TWO_SIDED|95.0|-2.28|-0.31||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.31|-2.28|0.0102
91732746|NCT04770285|183360603|SUPERIORITY||Treatment Difference|-1.58||||0.0029|TWO_SIDED|95.0|-2.62|-0.54||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.54|-2.62|0.0029
91732747|NCT04770285|183360604|SUPERIORITY||Ratio of Response Rate|1.18||||0.5757|TWO_SIDED|95.0|0.65|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||2.16|0.65|0.5757
91732748|NCT04770285|183360604|SUPERIORITY||Ratio of Response Rate|1.16||||0.5102|TWO_SIDED|95.0|0.75|1.78||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||1.78|0.75|0.5102
91732749|NCT04770285|183360604|SUPERIORITY||Ratio of Response Rate|1.15||||0.5342|TWO_SIDED|95.0|0.74|1.79||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.79|0.74|0.5342
91732750|NCT04770285|183360605|SUPERIORITY||Ratio of Response Rate|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Week 8||1.22|0.82|
91732751|NCT04770285|183360605|SUPERIORITY||Ratio of Response Rate|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||Week 10||1.25|0.88|
91732752|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.108|||<|0.001|TWO_SIDED|95.0|0.055|0.161|||Mixed Models Analysis|||||0.161|0.055|<0.001
91732753|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.117|||<|0.001|TWO_SIDED|95.0|0.064|0.171|||Mixed Models Analysis|||||0.171|0.064|<0.001
91732754|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.162|||<|0.001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|||||0.216|0.107|<0.001
91732755|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.069|0.175|||Mixed Models Analysis|||||0.175|0.069|<0.001
91732756|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.009||||0.556|TWO_SIDED|95.0|-0.021|0.039|||Mixed Models Analysis|||||0.039|-0.021|0.556
91732757|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.053||||0.001|TWO_SIDED|95.0|0.021|0.085|||Mixed Models Analysis|||||0.085|0.021|0.001
91732758|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.014||||0.365|TWO_SIDED|95.0|-0.016|0.044|||Mixed Models Analysis|||||0.044|-0.016|0.365
91732759|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.044||||0.006|TWO_SIDED|95.0|0.013|0.076|||Mixed Models Analysis|||||0.076|0.013|0.006
91732760|NCT02796651|183360678|SUPERIORITY||LSMean difference|0.005||||0.756|TWO_SIDED|95.0|-0.026|0.036|||Mixed Models Analysis|||||0.036|-0.026|0.756
91732761|NCT02796651|183360678|SUPERIORITY||LSMean difference|-0.039||||0.014|TWO_SIDED|95.0|-0.071|-0.008|||Mixed Models Analysis|||||-0.008|-0.071|0.014
91732762|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.091|0.169|||Mixed Models Analysis|||||0.169|0.091|<0.001
91732763|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.206|||Mixed Models Analysis|||||0.206|0.128|<0.001
91732764|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.224|||<|0.001|TWO_SIDED|95.0|0.184|0.263|||Mixed Models Analysis|||||0.263|0.184|<0.001
91494362|NCT03292588|182860489|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.85||||0.458|TWO_SIDED|95.0|0.55|1.31|||Mixed Models Analysis|||Did not meet FDA-approved dosing||1.31|0.55|0.458
91494363|NCT03292588|182860490|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.67||||0.025|TWO_SIDED|95.0|0.47|0.95|||Regression, Negative Binomial|||Fit FDA-approved dosing||0.95|0.47|0.025
91494364|NCT03292588|182860491|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3587|TWO_SIDED|95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3587
91494365|NCT03808493|182860505|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the least square means (LS-Means) between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0211|||||TWO_SIDED|90.0|-0.0752|0.0329||||||||0.0329|-0.0752|
91494366|NCT03808493|182860505|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0019|||||TWO_SIDED|90.0|-0.0778|0.0815||||||||0.0815|-0.0778|
91494367|NCT03808493|182860506|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0698|||||TWO_SIDED|90.0|-0.1404|0.0008||||||||0.0008|-0.1404|
91494368|NCT03808493|182860506|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0811|||||TWO_SIDED|90.0|-0.1658|0.0036||||||||0.0036|-0.1658|
91528891|NCT01474512|182933750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
91528892|NCT01474512|182933751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528893|NCT01474512|182933751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
91528894|NCT01474512|182933752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91494369|NCT03808493|182860507|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0199|||||TWO_SIDED|90.0|-0.0731|0.0333||||||||0.0333|-0.0731|
91494370|NCT03808493|182860507|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0035|||||TWO_SIDED|90.0|-0.076|0.083||||||||0.0830|-0.0760|
91494371|NCT03808493|182860508|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.1902|||||TWO_SIDED|90.0|0.0199|0.3605||||||||0.3605|0.0199|
91494372|NCT03808493|182860508|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.2142|||||TWO_SIDED|90.0|0.0558|0.3725||||||||0.3725|0.0558|
91494373|NCT03808493|182860509|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0311|||||TWO_SIDED|90.0|0.0022|0.0599||||||||0.0599|0.0022|
91494374|NCT03808493|182860509|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0306|||||TWO_SIDED|90.0|-0.0003|0.0616||||||||0.0616|-0.0003|
91494375|NCT03808493|182860510|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0209|||||TWO_SIDED|90.0|-0.0112|0.053||||||||0.0530|-0.0112|
91494376|NCT03808493|182860510|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0135|||||TWO_SIDED|90.0|-0.0508|0.0238||||||||0.0238|-0.0508|
91494377|NCT05526716|182860519|NON_INFERIORITY|Serotype 3|Geometric Mean Titers Ratio (GMT Ratio)|0.84|||||TWO_SIDED|95.0|0.72|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.97|0.72|
91528895|NCT01474512|182933752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91494378|NCT05526716|182860519|NON_INFERIORITY|Serotype 6A|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.66|
91494379|NCT05526716|182860519|NON_INFERIORITY|Serotype 7F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.63|
91494380|NCT05526716|182860519|NON_INFERIORITY|Serotype 8|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.61|0.82||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.82|0.61|
91494381|NCT05526716|182860519|NON_INFERIORITY|Serotype 9N|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.79||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.79|0.57|
91528896|NCT01474512|182933752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528897|NCT01474512|182933752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528898|NCT01474512|182933752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI100|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528899|NCT01474512|182933752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value if for PPASI100.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
91528900|NCT01089556|182933767|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.192||||0.37||95.0|||||Mixed Models Analysis|||||||0.370
91528901|NCT01089556|182933768|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.614|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91528902|NCT01089556|182933769|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.003||||0.991||95.0|||||Mixed Models Analysis|||||||0.991
91528903|NCT01089556|182933770|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.431|||<|0.001|TWO_SIDED|95.0|1.233|1.662|||Cochran-Mantel-Haenszel|||||1.662|1.233|<0.001
91528904|NCT01089556|182933771|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.052||||0.565|TWO_SIDED|95.0|0.884|1.253|||Cochran-Mantel-Haenszel|||||1.253|0.884|0.565
91494382|NCT05526716|182860519|NON_INFERIORITY|Serotype 10A|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
91494383|NCT05526716|182860519|NON_INFERIORITY|Serotype 11A|GMT Ratio|0.64|||||TWO_SIDED|95.0|0.54|0.75||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.75|0.54|
91528905|NCT01089556|182933772|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.467|||<|0.001|TWO_SIDED|95.0|1.214|1.771|||Cochran-Mantel-Haenszel|||||1.771|1.214|<0.001
91732765|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.176|0.253|||Mixed Models Analysis|||||0.253|0.176|<0.001
91494384|NCT05526716|182860519|NON_INFERIORITY|Serotype 12F|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.62|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.62|
91528906|NCT01089556|182933773|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.233||||0.068|TWO_SIDED|95.0|0.98|1.55|||Cochran-Mantel-Haenszel|||||1.550|0.980|0.068
91528907|NCT01089556|182933774|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.279|||<|0.001|TWO_SIDED|95.0|1.125|1.456|||Cochran-Mantel-Haenszel|||||1.456|1.125|<0.001
91528908|NCT01089556|182933775|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.985||||0.843|TWO_SIDED|95.0|0.842|1.151|||Cochran-Mantel-Haenszel|||||1.151|0.842|0.843
91528909|NCT01089556|182933776|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.341|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91528910|NCT01089556|182933777|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.073||||0.475||95.0|||||Mixed Models Analysis|||||||0.475
91528911|NCT01089556|182933778|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-4.758|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91528912|NCT01089556|182933779|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.933||||0.289||95.0|||||Mixed Models Analysis|||||||0.289
91528913|NCT01089556|182933780|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.02||||0.071||95.0|||||ANCOVA|||||||0.071
91528914|NCT01089556|182933781|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.193||||0.78||95.0|||||ANCOVA|||||||0.780
91528915|NCT01089556|182933782|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.558||||0.008||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.008
91528916|NCT01089556|182933782|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.423||||0.031||95.0||||p-value is for depression subscale score.|Mixed Models Analysis|||||||0.031
91528917|NCT01089556|182933783|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.615||||0.049||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.049
91528918|NCT01089556|182933783|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.378||||0.198||95.0||||P-value is for depression subscale score.|Mixed Models Analysis|||||||0.198
91528919|NCT01089556|182933788|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.343|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91528920|NCT01089556|182933789|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.095||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
91528921|NCT01089556|182933790|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-2.02||||0.064||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.064
91528922|NCT01089556|182933790|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.135||||0.843||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.843
91528923|NCT01089556|182933791|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.329||||0.354||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.354
91732766|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.265|||<|0.001|TWO_SIDED|95.0|0.226|0.304|||Mixed Models Analysis|||||0.304|0.226|<0.001
91732767|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.037||||0.004|TWO_SIDED|95.0|0.012|0.062|||Mixed Models Analysis|||||0.062|0.012|0.004
91528924|NCT01089556|182933791|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.003||||0.997||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.997
91528925|NCT01089556|182933792|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|3.317|||<|0.001||95.0|||||ANCOVA|||||||<0.001
91528926|NCT01089556|182933793|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.942||||0.332||95.0|||||ANCOVA|||||||0.332
91528927|NCT01089556|182933794|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Fisher Exact|||||||0.618
91494385|NCT05526716|182860519|NON_INFERIORITY|Serotype 15A|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.60|
91528928|NCT01089556|182933795|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Fisher Exact|||||||0.571
91528929|NCT01089556|182933796|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
91528930|NCT01089556|182933797|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
91732768|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.094|||<|0.001|TWO_SIDED|95.0|0.068|0.119|||Mixed Models Analysis|||||0.119|0.068|<0.001
91494386|NCT05526716|182860519|NON_INFERIORITY|Serotype 15C|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.58|
91494387|NCT05526716|182860519|NON_INFERIORITY|Serotype 16F|GMT Ratio|0.69|||||TWO_SIDED|95.0|0.59|0.81||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.81|0.59|
91494388|NCT05526716|182860519|NON_INFERIORITY|Serotype 17F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.62|
91494389|NCT05526716|182860519|NON_INFERIORITY|Serotype 19A|GMT Ratio|0.75|||||TWO_SIDED|95.0|0.65|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.65|
91528931|NCT01027364|182933854|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.17|||<|0.001|TWO_SIDED|95.0|0.11|0.24||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 95% power at the 2-sided 0.05 level of significance, based upon this hypothesis test.||0.24|0.11|<0.001
91528932|NCT01027364|182933854|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.2||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations.||0.20|0.08|<0.001
91528933|NCT02500979|182933869|SUPERIORITY_OR_OTHER||Least squares mean difference|-21.5|STANDARD_ERROR_OF_MEAN|7.88||0.0118|TWO_SIDED|95.0|-37.8|-5.2|||Linear mixed-effects model|||||-5.2|-37.8|0.0118
91528934|NCT02500979|182933870|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-7.897||||0.0013|TWO_SIDED|95.0|-12.356|-3.438|||Linear mixed effects model|||||-3.438|-12.356|0.0013
91528935|NCT02500979|182933871|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-5.277||||0.0091|TWO_SIDED|95.0|-9.175|-1.378|||Linear mixed effects model|||||-1.378|-9.175|0.0091
91528936|NCT02500979|182933872|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-4.435||||0.0057|TWO_SIDED|95.0|-7.445|-1.424|||Linear mixed effects model|||||-1.424|-7.445|0.0057
91528937|NCT02500979|182933873|SUPERIORITY_OR_OTHER||Least squares mean difference|-28733.0|STANDARD_ERROR_OF_MEAN|4163.6|<|0.0001|TWO_SIDED|95.0|-37326.0|-20139.0|||Linear mixed-effects model|||||-20139|-37326|<0.0001
91528938|NCT02500979|182933874|SUPERIORITY_OR_OTHER||LS mean difference|-28.418||||0.0258|TWO_SIDED|95.0|-53.099|-3.737|||Linear mixed-effects model|||||-3.737|-53.099|0.0258
91528939|NCT02500979|182933876|SUPERIORITY_OR_OTHER||LS Mean Ratio (Pramlintide/Placebo)|1.31||||0.0456|TWO_SIDED|95.0|1.01|1.7|||Linear mixed-effects model|||||1.70|1.01|0.0456
91528940|NCT02500979|182933877|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|0.951||||0.1015|TWO_SIDED|95.0|0.896|1.011|||Linear mixed-effects model|||||1.011|0.896|0.1015
91528941|NCT02500979|182933879|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|1.085||||0.373|TWO_SIDED|95.0|0.901|1.307|||Linear mixed effects model|||||1.307|0.901|0.3730
91528942|NCT00267111|182933884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant.|t-test, 2 sided|||We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of \< 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.||||< 0.05
91528943|NCT00267111|182933885|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant|t-test, 2 sided|||We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.||||<0.05
91528944|NCT01613027|182933897|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 6||||<0.001
91528945|NCT01613027|182933897|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 12||||<0.001
91528946|NCT02354963|182933913|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||||||0.302
91732769|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.059|0.11|||Mixed Models Analysis|||||0.110|0.059|<0.001
91732770|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.109|0.161|||Mixed Models Analysis|||||0.161|0.109|<0.001
91732771|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.057|||<|0.001|TWO_SIDED|95.0|0.031|0.082|||Mixed Models Analysis|||||0.082|0.031|<0.001
91732772|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.047|||<|0.001|TWO_SIDED|95.0|0.023|0.071|||Mixed Models Analysis|||||0.071|0.023|<0.001
91732773|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.073|0.123|||Mixed Models Analysis|||||0.123|0.073|<0.001
91732774|NCT02796651|183360679|SUPERIORITY||LSMean difference|-0.009||||0.469|TWO_SIDED|95.0|-0.035|0.016|||Mixed Models Analysis|||||0.016|-0.035|0.469
91494390|NCT05526716|182860519|NON_INFERIORITY|Serotype 20A|GMT Ratio|0.74|||||TWO_SIDED|95.0|0.63|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.63|
91732775|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.041||||0.002|TWO_SIDED|95.0|0.015|0.068|||Mixed Models Analysis|||||0.068|0.015|0.002
91732776|NCT02796651|183360679|SUPERIORITY||LSMean difference|0.051|||<|0.001|TWO_SIDED|95.0|0.025|0.076|||Mixed Models Analysis|||||0.076|0.025|<0.001
91732777|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.159|||<|0.001|TWO_SIDED|95.0|0.105|0.213|||Mixed Models Analysis|||||0.213|0.105|<0.001
91732778|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.17|||<|0.001|TWO_SIDED|95.0|0.116|0.224|||Mixed Models Analysis|||||0.224|0.116|<0.001
91732779|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.219|||<|0.001|TWO_SIDED|95.0|0.163|0.274|||Mixed Models Analysis|||||0.274|0.163|<0.001
91494391|NCT05526716|182860519|NON_INFERIORITY|Serotype 22F|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
91732780|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.179|||<|0.001|TWO_SIDED|95.0|0.125|0.233|||Mixed Models Analysis|||||0.233|0.125|<0.001
91494392|NCT05526716|182860519|NON_INFERIORITY|Serotype 23A|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.63|0.96||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.96|0.63|
91494393|NCT05526716|182860519|NON_INFERIORITY|Serotype 23B|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.44|0.72||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.72|0.44|
91494394|NCT05526716|182860519|NON_INFERIORITY|Serotype 24F|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.61|
91494395|NCT05526716|182860519|NON_INFERIORITY|Serotype 31|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.56|0.83||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.83|0.56|
91494396|NCT05526716|182860519|NON_INFERIORITY|Serotype 33F|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||1.01|0.70|
91494397|NCT05526716|182860519|NON_INFERIORITY|Serotype 35B|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of serotypes is \>0.50.||0.89|0.67|
91494398|NCT05526716|182860520|NON_INFERIORITY|A/H1N1|GMT Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.97|0.70|
91528947|NCT02354963|182933914|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
91732781|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.011||||0.488|TWO_SIDED|95.0|-0.02|0.042|||Mixed Models Analysis|||||0.042|-0.020|0.488
91732782|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.06|||<|0.001|TWO_SIDED|95.0|0.027|0.092|||Mixed Models Analysis|||||0.092|0.027|<0.001
91732783|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.02||||0.206|TWO_SIDED|95.0|-0.011|0.051|||Mixed Models Analysis|||||0.051|-0.011|0.206
91732784|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.049||||0.004|TWO_SIDED|95.0|0.016|0.081|||Mixed Models Analysis|||||0.081|0.016|0.004
91732785|NCT02796651|183360680|SUPERIORITY||LSMean difference|0.009||||0.567|TWO_SIDED|95.0|-0.022|0.041|||Mixed Models Analysis|||||0.041|-0.022|0.567
91732786|NCT02796651|183360680|SUPERIORITY||LSMean difference|-0.039||||0.017|TWO_SIDED|95.0|-0.072|-0.007|||Mixed Models Analysis|||||-0.007|-0.072|0.017
91732787|NCT02796651|183360681|SUPERIORITY||LSMean difference|0.075||||0.027|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||||0.141|0.008|0.027
91732788|NCT02796651|183360681|SUPERIORITY||LSMean difference|0.065||||0.054|TWO_SIDED|95.0|-0.001|0.131|||Mixed Models Analysis|||||0.131|-0.001|0.054
91732789|NCT02796651|183360681|SUPERIORITY||LSMean difference|0.1||||0.004|TWO_SIDED|95.0|0.032|0.168|||Mixed Models Analysis|||||0.168|0.032|0.004
91732790|NCT02796651|183360681|SUPERIORITY||LSMean difference|0.059||||0.075|TWO_SIDED|95.0|-0.006|0.123|||Mixed Models Analysis|||||0.123|-0.006|0.075
91732791|NCT02796651|183360681|SUPERIORITY||LSMean difference|-0.01||||0.615|TWO_SIDED|95.0|-0.048|0.028|||Mixed Models Analysis|||||0.028|-0.048|0.615
91732792|NCT02796651|183360681|SUPERIORITY||LSMean difference|0.025||||0.209|TWO_SIDED|95.0|-0.014|0.065|||Mixed Models Analysis|||||0.065|-0.014|0.209
91732793|NCT02796651|183360681|SUPERIORITY||LSMean difference|-0.016||||0.403|TWO_SIDED|95.0|-0.053|0.022|||Mixed Models Analysis|||||0.022|-0.053|0.403
91732794|NCT02796651|183360681|SUPERIORITY||LSMean difference|0.035||||0.074|TWO_SIDED|95.0|-0.003|0.074|||Mixed Models Analysis|||||0.074|-0.003|0.074
91732795|NCT02796651|183360681|SUPERIORITY||LSMean difference|-0.006||||0.75|TWO_SIDED|95.0|-0.045|0.032|||Mixed Models Analysis|||||0.032|-0.045|0.750
91732796|NCT02796651|183360681|SUPERIORITY||LSMean difference|-0.041||||0.035|TWO_SIDED|95.0|-0.08|-0.003|||Mixed Models Analysis|||||-0.003|-0.080|0.035
91732797|NCT00437073|183360683|SUPERIORITY_OR_OTHER||percentage of participants|38.0|||||TWO_SIDED|95.0|13.9|68.4|||||The estimated value indicates the percentage of participants with CNS OR in the Lapatinib plus Capecitabine treatment arm.|||68.4|13.9|
91528948|NCT02354963|182933915|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91528949|NCT02354963|182933916|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
91494399|NCT05526716|182860520|NON_INFERIORITY|A/H3N2|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.93|0.67|
91494400|NCT05526716|182860520|NON_INFERIORITY|B/Victoria|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.95|0.70|
91494401|NCT05526716|182860520|NON_INFERIORITY|B/Yamagata|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.0||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||1.00|0.78|
91494402|NCT05526716|182860521|OTHER|Serotype 3|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.02||||||||1.02|0.80|
91494403|NCT05526716|182860521|OTHER|Serotype 6A|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.79|1.11||||||||1.11|0.79|
91494404|NCT05526716|182860521|OTHER|Serotype 7F|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.67|0.9||||||||0.90|0.67|
91494405|NCT05526716|182860521|OTHER|Serotype 8|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||||0.95|0.70|
91494406|NCT05526716|182860521|OTHER|Serotype 9N|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.05||||||||1.05|0.75|
91494407|NCT05526716|182860521|OTHER|Serotype 10A|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||||0.94|0.67|
91494408|NCT05526716|182860521|OTHER|Serotype 11A|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.96||||||||0.96|0.72|
91494409|NCT05526716|182860521|OTHER|Serotype 12F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.01||||||||1.01|0.69|
91494410|NCT05526716|182860521|OTHER|Serotype 15A|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.63|0.9||||||||0.90|0.63|
91494411|NCT05526716|182860521|OTHER|Serotype 15C|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
91494412|NCT05526716|182860521|OTHER|Serotype 16F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||||0.99|0.70|
91494413|NCT05526716|182860521|OTHER|Serotype 17F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
91494414|NCT05526716|182860521|OTHER|Serotype 19A|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||||0.93|0.71|
91494415|NCT05526716|182860521|OTHER|Serotype 20A|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.97||||||||0.97|0.70|
91494416|NCT05526716|182860521|OTHER|Serotype 22F|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||||1.10|0.80|
91494417|NCT05526716|182860521|OTHER|Serotype 23A|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.7|1.03||||||||1.03|0.70|
91494418|NCT05526716|182860521|OTHER|Serotype 23B|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||||1.02|0.72|
91494419|NCT05526716|182860521|OTHER|Serotype 24F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
91494420|NCT05526716|182860521|OTHER|Serotype 31|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
91494421|NCT05526716|182860521|OTHER|Serotype 33F|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.94||||||||0.94|0.69|
91494422|NCT05526716|182860521|OTHER|Serotype 35B|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
91494423|NCT01438957|182860550|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
91494424|NCT01438957|182860550|SUPERIORITY|||||||0.003|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.003
91494425|NCT01438957|182860550|SUPERIORITY|||||||0.086|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.086
91494426|NCT01438957|182860550|SUPERIORITY||||||<|0.001|||||||Mantel-extension test|Stratified by the anesthesia type||Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.||||<0.001
91494427|NCT01438957|182860551|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
91494428|NCT01438957|182860551|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
91494429|NCT01438957|182860551|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
91494430|NCT01438957|182860551|SUPERIORITY|||||||0.329|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.329
91494431|NCT01438957|182860552|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
91494432|NCT01438957|182860552|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
91494433|NCT01438957|182860552|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
91494434|NCT01438957|182860552|SUPERIORITY|||||||0.371|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.371
91494435|NCT01438957|182860553|SUPERIORITY||||||<|0.001|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
91494436|NCT01438957|182860553|SUPERIORITY|||||||0.001|||||||Log Rank|Stratified by the anesthesia type||||||0.001
91494437|NCT01438957|182860553|SUPERIORITY|||||||0.212|||||||Log Rank|Stratified by the anesthesia type||||||0.212
91494438|NCT01438957|182860554|SUPERIORITY|||||||0.869|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.869
91528950|NCT02354963|182933917|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
91528951|NCT02354963|182933918|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
91528952|NCT02354963|182933919|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
91528953|NCT02354963|182933920|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
91528954|NCT02354963|182933921|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
91528955|NCT02354963|182933922|SUPERIORITY||Risk Ratio (RR)|0.36||||0.512|TWO_SIDED|95.0|0.04|3.05|||Chi-squared|||||3.05|0.04|0.512
91528956|NCT04267614|182933923|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91528957|NCT04267614|182933924|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91528958|NCT04267614|182933925|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91528959|NCT04267614|182933926|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91528960|NCT00119262|182933939|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|95.0|||||Fisher Exact|||||||0.12
91528961|NCT00119262|182933940|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Fisher Exact|||||||0.32
91528962|NCT00305864|182933979|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Log Rank|One-sided||A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.||||0.27
91528963|NCT03881059|182933981|SUPERIORITY||Slope Coefficient of Dose|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Regression, Logistic|||||0.17|0.05|<0.001
91528964|NCT02065570|182934017|SUPERIORITY||Adjusted risk difference|0.3||||0.939|TWO_SIDED|95.0|-8.1|8.8||Adjusted for previous infliximab use (or prior anti-tumor necrosis factor (TNF) use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.8|-8.1|0.939
91528965|NCT02065570|182934018|SUPERIORITY||Adjusted risk difference|3.2||||0.462|TWO_SIDED|95.0|-5.3|11.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.7|-5.3|0.462
91528966|NCT02065570|182934020|SUPERIORITY||Adjusted risk difference|4.6||||0.269|TWO_SIDED|95.0|-3.6|12.8||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||12.8|-3.6|0.269
91528967|NCT02065570|182934021|SUPERIORITY||Adjusted risk difference|1.8||||0.61|TWO_SIDED|95.0|-5.1|8.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.7|-5.1|0.610
91528968|NCT02065570|182934022|SUPERIORITY||Adjusted risk difference|11.2||||0.008|TWO_SIDED|95.0|2.9|19.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||19.6|2.9|0.008
91528969|NCT02065570|182934023|SUPERIORITY||Adjusted risk difference|6.0||||0.336|TWO_SIDED|95.0|-6.2|18.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||18.2|-6.2|0.336
91528970|NCT02065570|182934024|SUPERIORITY||Adjusted risk difference|1.5||||0.694|TWO_SIDED|95.0|-6.1|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-6.1|0.694
91528971|NCT02065570|182934025|SUPERIORITY||LS Mean of Difference|6.8||||0.946|TWO_SIDED|95.0|-192.3|205.9|||Cochran-Mantel-Haenszel|||||205.9|-192.3|0.946
91528972|NCT02065570|182934026|SUPERIORITY||Adjusted risk difference|4.0||||0.293|TWO_SIDED|95.0|-3.5|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-3.5|0.293
91528973|NCT02065570|182934027|SUPERIORITY||Adjusted risk difference|3.0||||0.304|TWO_SIDED|95.0|-2.7|8.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.6|-2.7|0.304
91528974|NCT02065570|182934028|SUPERIORITY||Adjusted risk difference|4.2||||0.092|TWO_SIDED|95.0|-0.7|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-0.7|0.092
91528975|NCT02065570|182934029|SUPERIORITY||Adjusted risk difference|3.6||||0.278|TWO_SIDED|95.0|-2.9|10.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||10.2|-2.9|0.278
91528976|NCT02065570|182934030|SUPERIORITY||Adjusted risk difference|3.7||||0.353|TWO_SIDED|95.0|-4.1|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-4.1|0.353
91702218|NCT00778102|183299414|SUPERIORITY_OR_OTHER||Difference in Response Rate (CR or PR)|18.9||||0.0612|TWO_SIDED|95.0|-2.1|40.0|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with confirmed best overall response of CR or PR.||40.0|-2.1|0.0612
91702219|NCT04643964|183299447|SUPERIORITY|||||||0.54|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. No covariates were included.||||.54
91702220|NCT04643964|183299448|SUPERIORITY|||||||0.92|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.92
91702221|NCT04643964|183299449|SUPERIORITY|||||||0.37|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There were three covariates in this model: QIDS at Time 1, gender, and COVID interference.||||.37
91702222|NCT04643964|183299450|SUPERIORITY|||||||0.87|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.87
91702223|NCT02368210|183299451|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
91702224|NCT02368210|183299452|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Scaling.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
91702225|NCT02368210|183299452|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: erythema.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
91702226|NCT02368210|183299452|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Plaque Elevation.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
91702227|NCT00078949|183299457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The literature has suggested that the ORR is approximately 50% for this patient population treated with DHAP. The treatment difference is defined as the response rate for the DHAP arm minus that of GDP arm. We would consider GDP to be non-inferior to DHAP if we are 95% sure that the true difference is less than 10%. In order to rule out that the 10% difference with 80% power, we need to accrue a total of 630 eligible patients. The actual sample size for this final analysis is 619 patients.|Risk Difference (RD)|-1.2||||0.005|TWO_SIDED|95.0|-9.0|6.7||p-value for non-inferiority|Cochran-Mantel-Haenszel|||||6.7|-9.0|0.005
91702228|NCT00078949|183299458|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.1||||0.55||95.0|-10.0|5.8|||Cochran-Mantel-Haenszel|||||5.8|-10.0|0.55
91702229|NCT00078949|183299459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.17|TWO_SIDED|95.0|0.52|1.12|||Log Rank|||It was estimated that 240 patients will be eligible for the maintenance question, and randomized with a 1:1 ratio to either rituximab or observation. It is expected that the 2-year event-free survival will be 50% on the observation arm. In order to detect a 15% difference in the 2-year event-free survival with an 80% power using a two-sided 5% level test, 142 events are required to detect an HR of 0.622.||1.12|0.52|0.17
91702230|NCT02539134|183299476|SUPERIORITY_OR_OTHER||Slope|1.06||||0.757|TWO_SIDED|90.0|0.741|1.374|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90 percent (%) confidence interval (CI) for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.374|0.741|0.757
91702231|NCT02539134|183299476|SUPERIORITY_OR_OTHER||Slope|1.37||||0.042|TWO_SIDED|90.0|1.078|1.664|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.664|1.078|0.042
91702232|NCT02539134|183299477|SUPERIORITY_OR_OTHER||Slope|1.2||||0.191|TWO_SIDED|90.0|0.946|1.45|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.450|0.946|0.191
91702233|NCT02539134|183299477|SUPERIORITY_OR_OTHER||Slope|1.37||||0.036|TWO_SIDED|90.0|1.089|1.657|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.657|1.089|0.036
91702234|NCT02539134|183299478|SUPERIORITY_OR_OTHER||Slope|1.19||||0.288|TWO_SIDED|90.0|0.89|1.489|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.489|0.890|0.288
91702235|NCT02539134|183299479|SUPERIORITY_OR_OTHER||Slope|1.36||||0.039|TWO_SIDED|90.0|1.08|1.642|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.642|1.080|0.039
91702236|NCT04068688|183299571|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91702237|NCT04068688|183299571|OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
91702238|NCT04068688|183299572|OTHER|||||||0.655|||||||Wilcoxon (Mann-Whitney)|||||||0.655
91702239|NCT04068688|183299572|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
91702240|NCT04068688|183299573|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
91702241|NCT04068688|183299573|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
91702242|NCT04068688|183299574|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||||||0.096
91702243|NCT04068688|183299574|OTHER|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||0.732
91528977|NCT02065570|182934031|SUPERIORITY||Adjusted risk difference|8.9||||0.015|TWO_SIDED|95.0|1.8|16.0||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||16.0|1.8|0.015
91732798|NCT04918771|183360706|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0003|TWO_SIDED|95.0|0.51|1.67|||t-test, 2 sided|||Mean time to resolution of ARVI symptoms||1.67|0.51|0.0003
91732799|NCT04918771|183360707|SUPERIORITY||Mean Difference (Final Values)|2.35||||0.3274|TWO_SIDED|95.0|-2.36|7.06|||t-test, 2 sided|||Mean AUC score for severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).||7.06|-2.36|0.3274
91732800|NCT04918771|183360707|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.1171|TWO_SIDED|95.0|-1.34|11.93|||t-test, 2 sided|||Mean AUC score for severity of ARVI (PCR-confirmed).||11.93|-1.34|0.1171
91732801|NCT04918771|183360708|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91732802|NCT04918771|183360709|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.0073|TWO_SIDED|95.0|0.16|1.0|||t-test, 2 sided|||The mean time to Resolution of ARVI Symptoms was analysed.||1.00|0.16|0.0073
91732803|NCT04918771|183360710|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91732804|NCT04918771|183360711|SUPERIORITY|||||||0.3627|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 1.||||0.3627
91732805|NCT04918771|183360711|SUPERIORITY|||||||0.5578|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 2.||||0.5578
91732806|NCT04918771|183360711|SUPERIORITY|||||||0.7688|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 3.||||0.7688
91732807|NCT04918771|183360712|SUPERIORITY|||||||0.4926|||||||Fisher Exact|||||||0.4926
91528978|NCT02065570|182934032|SUPERIORITY||Adjusted risk difference|3.4||||0.394|TWO_SIDED|95.0|-4.4|11.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.1|-4.4|0.394
91528979|NCT02065570|182934033|SUPERIORITY||Adjusted risk difference|3.6||||0.349|TWO_SIDED|95.0|-4.0|11.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||11.2|-4.0|0.349
91528980|NCT02065570|182934034|SUPERIORITY||Adjusted risk difference|7.6||||0.054|TWO_SIDED|95.0|-0.1|15.3||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||15.3|-0.1|0.054
91732808|NCT04918771|183360713|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Comparison of severity distributions.||||0.021
91732809|NCT04918771|183360713|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for outcome distribution.||||1.00
91528981|NCT02743793|182934035|OTHER|No test was performed.|Kaplan-Meier survival estimate|64.0|||||TWO_SIDED|95.0|21.3|87.9|||||Percent of participants that remained tolerant during study participation.|||87.9|21.3|
91528982|NCT02733042|182934050|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.|||
91732810|NCT04918771|183360714|SUPERIORITY|||||||0.7848|||||||Median test|||Comparison for Visit 1.||||0.7848
91732811|NCT04918771|183360714|SUPERIORITY|||||||0.9596|||||||Median test|||Comparison for Visit 2.||||0.9596
91732812|NCT04918771|183360714|SUPERIORITY|||||||0.6902|||||||Median test|||Comparison for Visit 3.||||0.6902
91732813|NCT04918771|183360715|SUPERIORITY|||||||0.3266|||||||Median test|||Comparison for Visit 1.||||0.3266
91732814|NCT04918771|183360715|SUPERIORITY|||||||0.093|||||||Median test|||Comparison for Visit 2.||||0.0930
91732815|NCT04918771|183360715|SUPERIORITY|||||||0.2308|||||||Median test|||Comparison for Visit 3.||||0.2308
91732816|NCT04918771|183360716|SUPERIORITY|||||||0.661|||||||Median test|||Comparison for Visit 1/Systolic blood pressure.||||0.6610
91732817|NCT04918771|183360716|SUPERIORITY|||||||0.4884|||||||Median test|||Comparison for Visit 2/Systolic blood pressure.||||0.4884
91732818|NCT04918771|183360716|SUPERIORITY|||||||0.3494|||||||Median test|||Comparison for Visit 3/Systolic blood pressure.||||0.3494
91732819|NCT04918771|183360716|SUPERIORITY|||||||0.9531|||||||Median test|||Comparison for Visit 1/Diastolic blood pressure.||||0.9531
91732820|NCT04918771|183360716|SUPERIORITY|||||||0.5506|||||||Median test|||Comparison for Visit 2/Diastolic blood pressure.||||0.5506
91732821|NCT04918771|183360716|SUPERIORITY|||||||0.8259|||||||Median test|||Comparison for Visit 3/Diastolic blood pressure.||||0.8259
91732822|NCT04918771|183360717|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91732823|NCT02702999|183360735|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
91732824|NCT02702999|183360736|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
91732825|NCT02702999|183360737|SUPERIORITY||Risk Ratio (RR)|1.9|||||TWO_SIDED|95.0|0.4|10.5|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||10.5|0.4|
91732826|NCT02702999|183360738|SUPERIORITY||Risk Ratio (RR)|5.4|||||TWO_SIDED|95.0|1.2|23.7|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||23.7|1.2|
91528983|NCT02733042|182934050|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².|||
91528984|NCT01088529|182934078|SUPERIORITY_OR_OTHER||Relative risk|1.432||||0.2148|TWO_SIDED|90.0|0.859|2.386|||Chi-squared|||||2.386|0.859|0.2148
91528985|NCT01088529|182934079|SUPERIORITY_OR_OTHER||Relative risk|0.477||||0.1796|TWO_SIDED|90.0|0.205|1.109|||Fisher Exact|||||1.109|0.205|0.1796
91528986|NCT01088529|182934080|SUPERIORITY_OR_OTHER||Relative risk|6.523|||<|0.0001|TWO_SIDED|90.0|2.701|15.753|||Chi-squared|||||15.753|2.701|<0.0001
91528987|NCT00337662|182934120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Between-group p-values for each baseline to post-baseline visit were the same, p\<0.001.|Mixed Effects Model Repeated Measures|||||||<0.001
91528988|NCT00337662|182934121|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Change from Week 2 to Week 3 p-value|Mixed-Effects Model Repeated-Measures|||||||0.266
91528989|NCT00337662|182934121|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||Change from Week 2 to Week 4 p-value|Mixed-Effects Model Repeated-Measures|||||||0.884
91528990|NCT00337662|182934121|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Change from Week 2 to Week 6 p-value|Mixed-Effects Model Repeated-Measures|||||||0.151
91528991|NCT00337662|182934121|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Change from Week 2 to Week 8 p-value|Mixed-Effects Model Repeated-Measures|||||||0.216
91528992|NCT00337662|182934121|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Change from Week 2 to Week 12 p-value|Mixed-Effects Model Repeated-Measures|||||||0.020
91528993|NCT00337662|182934122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91528994|NCT00337662|182934123|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||Fisher Exact|||||||0.604
91528995|NCT00337662|182934124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91528996|NCT00337662|182934125|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||Fisher Exact|||||||0.745
91528997|NCT00337662|182934126|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||||||0.474
91528998|NCT00337662|182934127|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.034
91528999|NCT00337662|182934127|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.125
91529000|NCT00337662|182934128|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||All comparisons between EO-RIS and NEO-RIS and between NEO-RIS and NEO-OLZ had p-values greater than 0.05.|Fisher Exact|||||||>0.05
91529001|NCT00337662|182934129|SUPERIORITY_OR_OTHER|||||||0.355||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.355
91529002|NCT00337662|182934129|SUPERIORITY_OR_OTHER|||||||0.244||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.244
91529003|NCT00337662|182934130|SUPERIORITY_OR_OTHER|||||||0.998||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.998
91529004|NCT00337662|182934130|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.505
91529005|NCT00337662|182934131|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.266
91529006|NCT00337662|182934131|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.015
91529007|NCT00337662|182934132|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.140
91529008|NCT00337662|182934132|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.181
91529009|NCT00337662|182934133|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.254
91529010|NCT00337662|182934133|SUPERIORITY_OR_OTHER|||||||0.299||95.0|||||ANOVA|P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.||||||0.299
91529011|NCT00337662|182934134|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.291
91529012|NCT00337662|182934134|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.259
91529013|NCT00337662|182934135|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.209
91529014|NCT00337662|182934135|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.411
91529015|NCT00337662|182934136|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.544
91529016|NCT00337662|182934136|SUPERIORITY_OR_OTHER|||||||0.386||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.386
91529017|NCT00337662|182934137|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.026
91529018|NCT00337662|182934137|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.143
91529019|NCT00882921|182934138|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.873||||0.1309|TWO_SIDED|95.0|0.731|11.296|||Negative Binomial Model|||The groups compared are Ab+ vs Ab-||11.296|0.731|0.1309
91702244|NCT04068688|183299575|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91702245|NCT04068688|183299575|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
91529020|NCT00882921|182934138|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.082||||0.2718|TWO_SIDED|95.0|0.563|7.706|||Negative Binomial Model|||The groups compared are Ab+ (age adjusted) vs Ab- (age adjusted)||7.706|0.563|0.2718
91529021|NCT03662360|182934140|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations in scores (T3 - T1) regarding the two interest groups of patients (control and treated).||||<0.001
91529022|NCT03662360|182934141|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations scores in T3 and T1, concerning the distress of the professional caregivers in the two intereste groups of patients||||<0.01
91529023|NCT03390036|182934159|SUPERIORITY|||||||0.8106|||||||ANOVA|||||||0.8106
91529024|NCT03390036|182934160|SUPERIORITY|||||||0.3007|||||||ANOVA|||||||0.3007
91529025|NCT03390036|182934161|SUPERIORITY|||||||0.6354|||||||ANOVA|||||||0.6354
91529026|NCT03390036|182934162|SUPERIORITY|||||||0.5754|||||||ANOVA|||||||0.5754
91529027|NCT03390036|182934163|SUPERIORITY|||||||0.4759|||||||ANOVA|||||||0.4759
91529028|NCT03390036|182934164|SUPERIORITY|||||||0.5596|||||||ANOVA|||||||0.5596
91529029|NCT03390036|182934165|SUPERIORITY|||||||0.4551|||||||ANOVA|||||||0.4551
91529030|NCT03390036|182934166|SUPERIORITY|||||||0.7931|||||||ANOVA|||||||0.7931
91529031|NCT06017999|182934184|SUPERIORITY||Least Square Mean (LSM) difference|-153.35|||<|0.0001|TWO_SIDED|95.0|-173.8|-132.91|||ANCOVA|||||-132.91|-173.80|<0.0001
91529032|NCT06017999|182934185|SUPERIORITY||Least Square Mean (LSM) difference|-131.64|||<|0.0001|TWO_SIDED|95.0|-153.13|-110.16|||ANCOVA|||||-110.16|-153.13|<0.0001
91732827|NCT02702999|183360739|SUPERIORITY||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.03|2.1|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.1|0.03|
91732828|NCT02702999|183360740|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.4|2.3|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.3|0.4|
91732829|NCT01287208|183360761|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91529033|NCT01702428|182934216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|-0.54|||||TWO_SIDED|95.0|-1.69|0.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||0.58|-1.69|
91529034|NCT01702428|182934216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.79|||||TWO_SIDED|95.0|-0.35|1.98|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.98|-0.35|
91529035|NCT01702428|182934216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.25|||||TWO_SIDED|95.0|-0.98|1.5|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.50|-0.98|
91529036|NCT01702428|182934217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
91529037|NCT01702428|182934217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.05|0.90|
91529038|NCT01702428|182934217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
91529039|NCT01702428|182934217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
91529040|NCT01702428|182934217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.11|0.95|
91732830|NCT01287208|183360764|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91732831|NCT04910165|183360766|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
91732832|NCT04910165|183360767|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
91529041|NCT01702428|182934217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
91529042|NCT01702428|182934218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.02|||||TWO_SIDED|95.0|-1.05|1.09|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.09|-1.05|
91529043|NCT01702428|182934218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.63|||||TWO_SIDED|95.0|-0.5|1.81|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.81|-0.50|
91529044|NCT01702428|182934218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.61|||||TWO_SIDED|95.0|-0.53|1.79|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.79|-0.53|
91529045|NCT01702428|182934219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|1.0|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||1.00|0.87|
91529046|NCT01702428|182934219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.97|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.11|0.97|
91529047|NCT01702428|182934219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|1.0|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.15|1.00|
91529048|NCT01702428|182934219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.04|1.19|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.19|1.04|
91529049|NCT01702428|182934219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.9|1.03|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.03|0.90|
91529050|NCT01702428|182934219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.84|0.96|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||0.96|0.84|
91529051|NCT01702428|182934220|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|0.14|||||TWO_SIDED|95.0|-1.3|1.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||1.58|-1.3|
91529052|NCT01702428|182934220|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.49|||||TWO_SIDED|95.0|-1.86|0.86|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.86|-1.86|
91702246|NCT04068688|183299576|OTHER|||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
91702247|NCT04068688|183299576|OTHER|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
91702248|NCT04068688|183299577|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
91702249|NCT04068688|183299577|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91702250|NCT04068688|183299581|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91702251|NCT04068688|183299582|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
91702252|NCT04068688|183299583|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91702253|NCT04068688|183299583|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
91702254|NCT04068688|183299584|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91702255|NCT04068688|183299584|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
91702256|NCT04068688|183299588|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91494439|NCT01438957|182860555|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
91702257|NCT04068688|183299588|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
91702258|NCT04679051|183299593|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Two-tailed paired t-tests were used to compare variables between time in bed conditions.||||0.36
91702259|NCT04679051|183299594|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Paired t-test comparing the two time in bed protocols.||||0.51
91702260|NCT04679051|183299595|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Paired t-test comparing peak forearm blood flow between sleep protocols.||||0.03
91702261|NCT04679051|183299596|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Paired t-test used to compare carotid-femoral pulse wave velocity (index of arterial stiffness) between sleep protocols.||||0.29
91702262|NCT04679051|183299597|SUPERIORITY||||||<|0.001||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on Manikin throughput scores.||||<0.001
91702263|NCT04679051|183299598|SUPERIORITY|||||||0.04||||||Null hypothesis is that there was no difference in the change of executive function following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on the number of correct answers during a Stroop color-word test.||||0.04
91702264|NCT04679051|183299599|SUPERIORITY|||||||0.02||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on throughput scores from a Switching task.||||0.02
91702265|NCT00231283|183299623|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|STANDARD_ERROR_OF_MEAN|1.71||||95.0|91.5|99.4|||Qualitative Comparison|Reported in qualitative/semi-quantitative comparitive fashion due to study design.||||99.4|91.5|
91702266|NCT00231283|183299624|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.6|||No formal statistical testing|||||8.6|0.6|
91702267|NCT00231283|183299625|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.5|||Descriptive statistics|||||8.5|0.6|
91702268|NCT00231283|183299626|SUPERIORITY_OR_OTHER||Percentage of participants|10.4||||||95.0|5.1|18.3|||Descriptive statistics|||||18.3|5.1|
91702269|NCT00772005|183299627|SUPERIORITY_OR_OTHER|||||||0.8514||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8514
91702270|NCT00772005|183299627|SUPERIORITY_OR_OTHER|||||||0.6995||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6995
91702271|NCT00772005|183299627|SUPERIORITY_OR_OTHER|||||||0.9766||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9766
91702272|NCT00772005|183299628|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7596
91702273|NCT00772005|183299628|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5620
91702274|NCT00772005|183299628|SUPERIORITY_OR_OTHER|||||||0.6688||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6688
91702275|NCT00772005|183299629|SUPERIORITY_OR_OTHER|||||||0.1894||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1894
91702276|NCT00772005|183299629|SUPERIORITY_OR_OTHER|||||||0.4582||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4582
91494440|NCT01438957|182860556|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
91494441|NCT01438957|182860557|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
91494442|NCT01438957|182860557|SUPERIORITY|||||||0.002|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.002
91494443|NCT01438957|182860557|SUPERIORITY|||||||0.116|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.116
91494444|NCT01438957|182860558|SUPERIORITY|||||||0.088|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.088
91494445|NCT01438957|182860559|SUPERIORITY|||||||0.085|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.085
91494446|NCT01438957|182860560|SUPERIORITY|||||||0.005|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.005
91494447|NCT01438957|182860560|SUPERIORITY|||||||0.014|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.014
91702277|NCT00772005|183299629|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
91494448|NCT01438957|182860560|SUPERIORITY|||||||0.055|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.055
91494449|NCT01438957|182860561|SUPERIORITY|||||||0.737|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.737
91494450|NCT01438957|182860562|SUPERIORITY|||||||0.11|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.11
91494451|NCT01438957|182860563|SUPERIORITY|||||||0.567|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.567
91494452|NCT01438957|182860564|SUPERIORITY|||||||0.044|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.044
91494453|NCT01438957|182860564|SUPERIORITY|||||||0.234|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.234
91494454|NCT01438957|182860565|SUPERIORITY|||||||0.729|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.729
91702278|NCT00772005|183299630|SUPERIORITY_OR_OTHER|||||||0.3275||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3275
91702279|NCT00772005|183299630|SUPERIORITY_OR_OTHER|||||||0.2597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2597
91702280|NCT00772005|183299630|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0039
91702281|NCT00772005|183299631|SUPERIORITY_OR_OTHER|||||||0.0713||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0713
91702282|NCT00772005|183299631|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0431
91702283|NCT00772005|183299631|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0063
91702284|NCT00772005|183299632|SUPERIORITY_OR_OTHER|||||||0.0619||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0619
91702285|NCT00772005|183299632|SUPERIORITY_OR_OTHER|||||||0.1137||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1137
91702286|NCT00772005|183299632|SUPERIORITY_OR_OTHER|||||||0.0598||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0598
91494455|NCT01438957|182860566|SUPERIORITY|||||||0.082|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.082
91494456|NCT01438957|182860567|SUPERIORITY|||||||0.451|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.451
91494457|NCT01438957|182860568|SUPERIORITY|||||||0.873|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.873
91494458|NCT01438957|182860569|SUPERIORITY|||||||0.374|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.374
91494459|NCT00133952|182860577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.724|TWO_SIDED|95.0|0.15|2.67|||Fisher Exact|||||2.67|0.15|0.724
91494460|NCT00133952|182860578|SUPERIORITY_OR_OTHER||LS Mean difference|-3.3||||0.616|TWO_SIDED|95.0|-16.5|9.8|||Mixed models repeated measures|||||9.8|-16.5|0.616
91494461|NCT00133952|182860579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||||1.44|0.68|0.971
91494462|NCT00133952|182860581|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.344|TWO_SIDED|95.0|-0.6|1.6|||Mixed models repeated measures|||||1.6|-0.6|0.344
91494463|NCT00133952|182860582|SUPERIORITY_OR_OTHER|||||||0.663||95.0|||||ANCOVA|||||||0.663
91494464|NCT00133952|182860583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.203|TWO_SIDED|95.0|0.37|1.23|||Cochran-Mantel-Haenszel|||||1.23|0.37|0.203
91494465|NCT00133952|182860585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.749|TWO_SIDED|95.0|0.46|2.92|||Cochran-Mantel-Haenszel|||||2.92|0.46|0.749
91494466|NCT04592874|182860586|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.7975|TWO_SIDED|95.0|-1.49|1.15|||Mixed Models Analysis|||This is using the Week 96 timepoint||1.15|-1.49|0.7975
91494467|NCT04592874|182860586|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.6341|TWO_SIDED|95.0|-1.61|0.98|||Mixed Models Analysis|||This is using the Week 96 timepoint||0.98|-1.61|0.6341
91494468|NCT04592874|182860586|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.8489|TWO_SIDED|95.0|-1.18|1.43|||Mixed Models Analysis|||This is using the Week 96 timepoint||1.43|-1.18|0.8489
91494469|NCT04592874|182860587|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.7417|TWO_SIDED|95.0|-2.81|2.01|||Mixed Models Analysis|||This is using the Week 96 timepoint||2.01|-2.81|0.7417
91494470|NCT04592874|182860587|SUPERIORITY||Mean Difference (Final Values)|-1.74||||0.1559|TWO_SIDED|95.0|-4.16|0.67|||Mixed Models Analysis|||This is using the Week 96 timepoint||0.67|-4.16|0.1559
91494471|NCT04592874|182860587|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.785|TWO_SIDED|95.0|-2.78|2.11|||Mixed Models Analysis|||This is using the Week 96 timepoint||2.11|-2.78|0.7850
91494472|NCT04592874|182860588|SUPERIORITY||Mean Difference (Final Values)|-0.65||||0.7934|TWO_SIDED|95.0|-5.58|4.28|||Mixed Models Analysis|||This is using the Week 96 timepoint||4.28|-5.58|0.7934
91494473|NCT04592874|182860588|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.9259|TWO_SIDED|95.0|-4.84|5.32|||Mixed Models Analysis|||This is using the Week 96 timepoint||5.32|-4.84|0.9259
91494474|NCT04592874|182860588|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.7147|TWO_SIDED|95.0|-4.04|5.87|||Mixed Models Analysis|||This is using the Week 96 timepoint||5.87|-4.04|0.7147
91494475|NCT04592874|182860589|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.6403|TWO_SIDED|95.0|-3.14|5.09|||Mixed Models Analysis|||This is using the Week 96 timepoint||5.09|-3.14|0.6403
91494476|NCT04592874|182860589|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.5016|TWO_SIDED|95.0|-2.71|5.51|||Mixed Models Analysis|||This is using the Week 96 timepoint||5.51|-2.71|0.5016
91494477|NCT04592874|182860589|SUPERIORITY||Mean Difference (Final Values)|2.94||||0.1631|TWO_SIDED|95.0|-1.21|7.08|||Mixed Models Analysis|||This is using the Week 96 timepoint||7.08|-1.21|0.1631
91494478|NCT04592874|182860590|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.7945|TWO_SIDED|95.0|-4.57|3.51|||Mixed Models Analysis|||This is using the Week 96 timepoint||3.51|-4.57|0.7945
91494479|NCT04592874|182860590|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.9371|TWO_SIDED|95.0|-3.92|4.25|||Mixed Models Analysis|||This is using the Week 96 timepoint||4.25|-3.92|0.9371
91702287|NCT00772005|183299633|SUPERIORITY_OR_OTHER|||||||0.7093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7093
91494480|NCT04592874|182860590|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.7991|TWO_SIDED|95.0|-3.58|4.64|||Mixed Models Analysis|||This is using the Week 96 timepoint||4.64|-3.58|0.7991
91494481|NCT04592874|182860591|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.6458|TWO_SIDED|95.0|-0.17|0.11|||Mixed Models Analysis|||This is using the Week 96 timepoint||0.11|-0.17|0.6458
91702288|NCT00772005|183299633|SUPERIORITY_OR_OTHER|||||||0.5129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5129
91702289|NCT00772005|183299633|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1097
91702290|NCT00772005|183299634|SUPERIORITY_OR_OTHER|||||||0.4291||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4291
91702291|NCT00772005|183299634|SUPERIORITY_OR_OTHER|||||||0.3195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3195
91494482|NCT04592874|182860591|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.2779|TWO_SIDED|95.0|-0.06|0.21|||Mixed Models Analysis|||This is using the Week 96 timepoint||0.21|-0.06|0.2779
91494483|NCT04592874|182860591|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.5355|TWO_SIDED|95.0|-0.1|0.18|||Mixed Models Analysis|||This is using the Week 96 timepoint||0.18|-0.10|0.5355
91494484|NCT02321800|182860672|NON_INFERIORITY|The margin of noninferiority was 20%. Noninferiority was concluded if the lower bound of a 2-sided 95% CI for the difference in response rates between the 2 treatment groups was greater than -20%. If the noninferiority inference based on the 20% margin was concluded successfully, noninferiority inference based on the 15% margin was performed.|Treatment Difference|18.58|||||TWO_SIDED|95.0|8.23|28.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||28.92|8.23|
91494485|NCT02321800|182860673|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-6.48|7.79||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.79|-6.48|
91494486|NCT02321800|182860674|OTHER||Treatment Difference|0.72|||||TWO_SIDED|95.0|-3.48|4.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||4.92|-3.48|
91529053|NCT01702428|182934220|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.62|||||TWO_SIDED|95.0|-2.02|0.74|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.74|-2.02|
91529054|NCT01702428|182934221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||"Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.~."||1.15|1.01|
91732833|NCT04910165|183360768|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
91732834|NCT04910165|183360769|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
91494487|NCT02321800|182860675|OTHER||Treatment Difference|15.31|||||TWO_SIDED|95.0|4.69|25.92||||||||25.92|4.69|
91529055|NCT01702428|182934221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.94|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||1.07|0.94|
91494488|NCT02321800|182860676|OTHER||Treatment Difference|17.25|||||TWO_SIDED|95.0|6.92|27.58||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||27.58|6.92|
91494489|NCT02321800|182860677|OTHER||Treatment Difference|1.28|||||TWO_SIDED|95.0|-4.83|7.39||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.39|-4.83|
91494490|NCT02321800|182860678|OTHER||Treatment Difference|1.1|||||TWO_SIDED|95.0|-3.04|5.25||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||5.25|-3.04|
91494491|NCT02321800|182860679|OTHER||Treatment Difference|13.92|||||TWO_SIDED|95.0|3.21|24.63||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||24.63|3.21|
91529056|NCT01702428|182934221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
91702292|NCT00772005|183299634|SUPERIORITY_OR_OTHER|||||||0.1591||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1591
91702293|NCT00772005|183299635|SUPERIORITY_OR_OTHER|||||||0.7768||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7768
91702294|NCT00772005|183299635|SUPERIORITY_OR_OTHER|||||||0.4014||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4014
91732835|NCT04910165|183360770|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
91732836|NCT04910165|183360771|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
91494492|NCT02321800|182860684|OTHER||Treatment Difference|2.39|||||TWO_SIDED|95.0|-4.66|9.44||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||9.44|-4.66|
91494493|NCT02321800|182860685|OTHER||Treatment Difference|-0.26|||||TWO_SIDED|95.0|-6.57|6.05||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||6.05|-6.57|
91494494|NCT02321800|182860686|OTHER||Treatment Difference|-1.07|||||TWO_SIDED|95.0|-3.42|1.29||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||1.29|-3.42|
91494495|NCT02321800|182860687|OTHER||Treatment Difference|9.02|||||TWO_SIDED|95.0|-0.37|18.41||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||18.41|-0.37|
91494496|NCT01115101|182860765|NON_INFERIORITY_OR_EQUIVALENCE|VAS score at 24h were defined as primary endpoint because of the expectation of the maximal effect at this time. Testing for differences of continuous variables between the study groups at baseline was accomplished by the 2-sample t test for independent samples or the Mann-Whitney U test, as appropriate.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|<|0.05||95.0|||||Chi-squared|Test selection was based on evaluating the variables for normal distribution employing the Kolmogorov-Smirnov test.||"The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time)."||||<0.05
91494497|NCT02454296|182860772|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91529057|NCT01702428|182934221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
91529058|NCT01702428|182934221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.93|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||1.07|0.93|
91494498|NCT02454296|182860773|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91494499|NCT02454296|182860774|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
91494500|NCT03366337|182860842|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|9.31|STANDARD_ERROR_OF_MEAN|1.3743|<|0.0001|TWO_SIDED|95.0|6.5|12.13|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.13|6.5|<0.0001
91494501|NCT03366337|182860842|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|8.0|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|4.75|11.25|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||11.25|4.75|<0.0001
91494502|NCT03366337|182860842|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|5.46|STANDARD_ERROR_OF_MEAN|2.2792||0.0247|TWO_SIDED|95.0|0.76|10.16|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||10.16|0.76|0.0247
91494503|NCT03366337|182860842|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|7.83|STANDARD_ERROR_OF_MEAN|2.216||0.003|TWO_SIDED|95.0|3.11|12.55|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.55|3.11|0.0030
91494504|NCT00769392|182860843|OTHER|||||||0.28|||||||single factor analysis of variance|||A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.||||0.28
91494505|NCT00769392|182860844|OTHER|||||||0.17|||||||single factor analysis of variance|||A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.||||0.17
91494506|NCT02296320|182860845|SUPERIORITY||Relative risk reduction|31.9||||0.166|TWO_SIDED|90.0|-7.5|56.8|||Poisson regression with robust variance|||The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.||56.8|-7.5|0.166
91494507|NCT01697566|182860881|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Body Weight||||0.006
91494508|NCT01697566|182860881|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fat Mass||||<0.001
91529059|NCT01702428|182934221|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.||1.15|1.01|
91732837|NCT04910165|183360772|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
91494509|NCT01697566|182860883|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
91494510|NCT01447433|182860885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.439|STANDARD_ERROR_OF_MEAN|0.56||0.441|TWO_SIDED|95.0|-0.7|1.58|||t-test, 2 sided|||||1.58|-0.70|0.441
91494511|NCT01447433|182860886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_ERROR_OF_MEAN|0.41||0.038|TWO_SIDED|95.0|0.05|1.7|||t-test, 2 sided|||Body Fat Mass||1.70|0.05|0.038
91494512|NCT01447433|182860886|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.082|TWO_SIDED|95.0|-1.06|0.07|||t-test, 2 sided|||Body Lean Mass||0.07|-1.06|0.082
91529060|NCT01702428|182934222|NON_INFERIORITY|The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to measles virus.|Difference in seroresponse rate|0.18|||||TWO_SIDED|95.0|-0.68|1.25|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-measles antibody concentration at Day 42.||1.25|-0.68|
91529061|NCT01702428|182934223|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.93|1.05|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to measles virus at Day 42.||1.05|0.93|
91529062|NCT01702428|182934224|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to mumps virus.|Difference in seroresponse rate|0.81|||||TWO_SIDED|95.0|-0.1|1.96|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.||1.96|-0.1|
91494513|NCT01447433|182860886|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.32|||t-test, 2 sided|||Visceral Fat Mass||0.32|0.03|0.018
91494514|NCT01447433|182860887|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.49||0.031|TWO_SIDED|95.0|0.1|2.09|||t-test, 2 sided|||||2.09|0.10|0.031
91494515|NCT01447433|182860888|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.72|STANDARD_ERROR_OF_MEAN|2.25||0.016|TWO_SIDED|95.0|1.15|10.29|||t-test, 2 sided|||||10.29|1.15|0.016
91494516|NCT01447433|182860889|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.14|STANDARD_ERROR_OF_MEAN|1.7||0.508|TWO_SIDED|95.0|-2.31|4.58|||t-test, 2 sided|||Waist Circumference||4.58|-2.31|0.508
91494517|NCT01447433|182860889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|2.07||0.56|TWO_SIDED|95.0|-5.42|2.98|||t-test, 2 sided|||Abdominal Circumference||2.98|-5.42|0.560
91529063|NCT01702428|182934225|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to mumps virus.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.99|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to mumps virus at Day 42.||1.11|0.99|
91529064|NCT01702428|182934226|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to rubella virus.|Difference in seroresponse rate|-1.15|||||TWO_SIDED|95.0|-2.0|-0.15|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.||-0.15|-2.00|
91529065|NCT01702428|182934227|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.83|0.92|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to rubella virus at Day 42.||0.92|0.83|
91732838|NCT01813357|183360773|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.684|TWO_SIDED||||||Mixed Models Analysis|||||||0.684
91732839|NCT01441492|183360782|OTHER|||||||0.804|||||||Chi-squared|||the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.||||0.804
91732840|NCT03863574|183360799|OTHER|Proof of Concept||||||0.7689|||||||t-test, 2 sided|||||||0.7689
91732841|NCT03863574|183360799|OTHER|Proof-of-concept||||||0.6007|||||||t-test, 2 sided|||||||0.6007
91732842|NCT03863574|183360800|OTHER|||||||0.5238|||||||Fisher Exact|||||||0.5238
91732843|NCT03863574|183360800|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
91732844|NCT03863574|183360801|OTHER|Proof-of-concept||||||0.0476|||||||Fisher Exact|||||||0.0476
91732845|NCT03863574|183360801|OTHER|Proof-of-concept||||||0.0333|||||||Fisher Exact|||||||0.0333
91732846|NCT03863574|183360802|OTHER|Proof-of-concept||||||0.6845|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.6845
91732847|NCT03863574|183360802|OTHER|Proof-of-concept||||||0.4625|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.4625
91732848|NCT03863574|183360802|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Lobular Inflammation||||0.1705
91732849|NCT03863574|183360802|OTHER|Proof-of-concept||||||0.3122|||||||t-test, 2 sided|||Outcome variable: Lobular Inflammation||||0.3122
91732850|NCT03863574|183360802|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.1705
91732851|NCT03863574|183360802|OTHER|Proof-of-concept||||||0.3877|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.3877
91732852|NCT03863574|183360803|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||||||0.1705
91732853|NCT03863574|183360803|OTHER|Proof-of-concept||||||0.174|||||||t-test, 2 sided|||||||0.1740
91732854|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.8019|||||||t-test, 2 sided|||Outcome variable: Alanine Aminotransferase||||0.8019
91732855|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.5396|||||||t-test, 2 sided|||Outcome Variable: Alanine Aminotransferase||||0.5396
91732856|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.774|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.7740
91494518|NCT01447433|182860889|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|0.85||0.255|TWO_SIDED|95.0|-0.74|2.7|||t-test, 2 sided|||Hip Circumference||2.70|-0.74|0.255
91494519|NCT01447433|182860890|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|4.5||0.404|TWO_SIDED|95.0|-12.9|5.3|||t-test, 2 sided|||Systolic Blood Pressure||5.3|-12.9|0.404
91494520|NCT01447433|182860890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.18||0.768|TWO_SIDED|95.0|-5.52|7.41|||t-test, 2 sided|||Diastolic Blood Pressure||7.41|-5.52|0.768
91494521|NCT01447433|182860891|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.565|TWO_SIDED|95.0|-0.36|0.2|||t-test, 2 sided|||TC||0.20|-0.36|0.565
91732857|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.9221|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.9221
91732858|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.003|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0030
91732859|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.0177|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0177
91732860|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.1399|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.1399
91732861|NCT03863574|183360804|OTHER|Proof-of-concept||||||0.2384|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.2384
91732862|NCT03863574|183360805|OTHER|Proof-of-concept||||||0.2218|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.2218
91732863|NCT03863574|183360805|OTHER|Proof-of-Concept||||||0.1483|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.1483
91732864|NCT03863574|183360805|OTHER|Proof-of-concept||||||0.0839|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.0839
91732865|NCT03863574|183360805|OTHER|Proof-of-concept||||||0.2895|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.2895
91732866|NCT03863574|183360806|OTHER|Proof-of-concept||||||0.6808|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.6808
91732867|NCT03863574|183360806|OTHER|Proof-of-concept||||||0.5351|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.5351
91732868|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.2329|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.2329
91732869|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.7211|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.7211
91732870|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.652|||||||t-test, 2 sided|||Outcome Variables: Total Cholesterol||||0.6520
91732871|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.4302|||||||t-test, 2 sided|||Outcome Variable: Total Cholesterol||||0.4302
91732872|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.9432|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.9432
91732873|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.2133|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.2133
91732874|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.2446|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.2446
91732875|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.7075|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.7075
91732876|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.2195|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.2195
91732877|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.7435|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.7435
91732878|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.5702|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.5702
91732879|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.6441|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.6441
91732880|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.8415|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.8415
91732881|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.0786|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.0786
91732882|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.8878|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein B||||0.8878
91732883|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.3219|||||||t-test, 2 sided|||Outcome variable: Apo lipoprotein B||||0.3219
91732884|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.6557|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.6557
91732885|NCT03863574|183360807|OTHER|Proof-of-concept||||||0.0763|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.0763
91732886|NCT03863574|183360809|OTHER|Proof-of-concept||||||0.6988|||||||t-test, 2 sided|||||||0.6988
91732887|NCT03863574|183360809|OTHER|Proof-of-concept||||||0.7413|||||||t-test, 2 sided|||||||0.7413
91732888|NCT03863574|183360810|OTHER|Proof-of-concept||||||0.22|||||||t-test, 2 sided|||||||0.2200
91732889|NCT03863574|183360810|OTHER|Proof-of-concept||||||0.5798|||||||t-test, 2 sided|||||||0.5798
91732890|NCT03863574|183360811|OTHER|Proof-of-concept||||||0.4981|||||||t-test, 2 sided|||||||0.4981
91732891|NCT03863574|183360811|OTHER|Proof-of-concept||||||0.8939|||||||t-test, 2 sided|||||||0.8939
91732892|NCT03863574|183360812|OTHER|Proof-of-concept||||||0.3605|||||||t-test, 2 sided|||||||0.3605
91732893|NCT03863574|183360812|OTHER|Proof-of-concept||||||0.8394|||||||t-test, 2 sided|||||||0.8394
91494522|NCT01447433|182860891|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.15||0.636|TWO_SIDED|95.0|-0.24|0.39|||t-test, 2 sided|||TG||0.39|-0.24|0.636
91529066|NCT01702428|182934228|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV\_MMR Group minus pooled COM\_MMR Group) should be ≥-10% for antibodies to VZV.|Difference in seroresponse rate|1.3|||||TWO_SIDED|95.0|-1.31|4.29|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|In US sub-cohort: Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.||4.29|-1.31|
91529067|NCT01702428|182934229|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to VZV.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.95|1.08|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to VZV virus at Day 42.||1.08|0.95|
91529068|NCT01702428|182934231|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) was ≥0.5 for antibodies to HAV virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to HAV virus at Day 42.||1.11|0.86|
91529069|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 1 antibody at Day 42.||1.05|0.85|
91529070|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 3 antibody at Day 42.||1.08|0.91|
91529071|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.88||||||95.0|0.79|0.98|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 4 antibody at Day 42.||0.98|0.79|
91529072|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.83|1.01|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 5 antibody at Day 42.||1.01|0.83|
91529073|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6A antibody at Day 42.||1.11|0.92|
91529074|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.89|1.09|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6B antibody at Day 42.||1.09|0.89|
91529075|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 7F antibody at Day 42.||1.03|0.86|
91529076|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 9V antibody at Day 42.||1.08|0.90|
91529077|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 14 antibody at Day 42.||1.02|0.81|
91702295|NCT00772005|183299635|SUPERIORITY_OR_OTHER|||||||0.4016||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4016
91494523|NCT01447433|182860891|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.112|TWO_SIDED|95.0|-0.58|0.06|||t-test, 2 sided|||HDL||0.06|-0.58|0.112
91494524|NCT01447433|182860891|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.647|TWO_SIDED|95.0|-0.11|0.05|||t-test, 2 sided|||LDL||0.05|-0.11|0.647
91494525|NCT01447433|182860892|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.26|TWO_SIDED|95.0|-0.1|0.35|||t-test, 2 sided|||||0.35|-0.10|0.260
91494526|NCT01447433|182860893|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|1.63||0.598|TWO_SIDED|95.0|-2.44|4.17|||t-test, 2 sided|||||4.17|-2.44|0.598
91732894|NCT03863574|183360813|OTHER|Proof-of-concept||||||0.2665|||||||t-test, 2 sided|||||||0.2665
91494527|NCT01447433|182860894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.5|STANDARD_ERROR_OF_MEAN|89.0||0.275|TWO_SIDED|95.0|-81.6|278.7|||t-test, 2 sided|||||278.7|-81.6|0.275
91494528|NCT04518293|182860897|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).|LS Means Difference|-5.44|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-6.774|-4.107|||MIANALYZE procedure|||The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.107|-6.774|<.0001
91494529|NCT04518293|182860897|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.723|-1.251|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.251|-3.723|<.0001
91494530|NCT04518293|182860897|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.42|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.758|-3.091|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.091|-5.758|<.0001
91494531|NCT04518293|182860898|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a MMRM.|LS Means Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.863|<|0.0001|TWO_SIDED|95.0|-7.307|-3.902|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 between dual-TA arms.||-3.902|-7.307|<.0001
91494532|NCT04518293|182860898|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.33|STANDARD_ERROR_OF_MEAN|1.212||0.0005|TWO_SIDED|95.0|-6.718|-1.933|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.933|-6.718|0.0005
91494533|NCT04518293|182860898|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-6.33|STANDARD_ERROR_OF_MEAN|0.837|<|0.0001|TWO_SIDED|95.0|-7.984|-4.68|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-4.680|-7.984|<.0001
91494534|NCT04518293|182860899|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-5.01|STANDARD_ERROR_OF_MEAN|0.858|<|0.0001|TWO_SIDED|95.0|-6.703|-3.317|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TA arms.||-3.317|-6.703|<.0001
91494535|NCT04518293|182860899|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.91||0.0002|TWO_SIDED|95.0|-5.293|-1.7|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.700|-5.293|0.0002
91494536|NCT04518293|182860899|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.35|STANDARD_ERROR_OF_MEAN|0.965|<|0.0001|TWO_SIDED|95.0|-7.251|-3.444|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.444|-7.251|<.0001
91494537|NCT04518293|182860900|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.72|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-4.692|-2.757|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.757|-4.692|<.0001
91494538|NCT04518293|182860900|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-3.51|STANDARD_ERROR_OF_MEAN|0.702|<|0.0001|TWO_SIDED|95.0|-4.897|-2.128|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-2.128|-4.897|<.0001
91494539|NCT04518293|182860900|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|95.0|-5.812|-3.189|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-3.189|-5.812|<.0001
91494540|NCT04518293|182860901|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.487|<|0.0001|TWO_SIDED|95.0|-3.392|-1.469|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-1.469|-3.392|<.0001
91494541|NCT04518293|182860901|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.29|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-3.371|-1.201|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.201|-3.371|<.0001
91494542|NCT04518293|182860901|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.562|<|0.0001|TWO_SIDED|95.0|-4.882|-2.664|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.664|-4.882|<.0001
91494543|NCT04518293|182860902|OTHER||Risk Difference (RD)|12.52||||0.0003|TWO_SIDED|95.0|5.63|19.487|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||19.487|5.630|0.0003
91494544|NCT04518293|182860902|OTHER||Risk Difference (RD)|13.36||||0.0001|TWO_SIDED|95.0|6.392|20.394|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||20.394|6.392|0.0001
91494545|NCT04518293|182860902|OTHER||Risk Difference (RD)|20.97|||<|0.0001|TWO_SIDED|95.0|13.812|28.013|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||28.013|13.812|<.0001
91494546|NCT04518293|182860903|OTHER||Risk Difference (RD)|10.31||||0.0044|TWO_SIDED|95.0|3.044|17.535|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||17.535|3.044|0.0044
91494547|NCT04518293|182860903|OTHER||Risk Difference (RD)|8.08||||0.0262|TWO_SIDED|95.0|0.804|15.373|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.373|0.804|0.0262
91494548|NCT04518293|182860903|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.201|25.746|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||25.746|11.201|<.0001
91494549|NCT04518293|182860904|OTHER||Risk Difference (RD)|16.51|||<|0.0001|TWO_SIDED|95.0|9.707|22.837|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||22.837|9.707|<.0001
91529078|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 18C antibody at Day 42.||1.02|0.84|
91529079|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.87|1.07|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19A antibody at Day 42.||1.07|0.87|
91529080|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19F antibody at Day 42.||1.06|0.87|
91529081|NCT01702428|182934232|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 23F antibody at Day 42.||1.06|0.85|
91529082|NCT02771210|182934252|SUPERIORITY||Odds Ratio (OR)|1.63||||0.136|TWO_SIDED|95.0|0.87|3.08|||Regression, Logistic|||||3.08|0.87|0.136
91529083|NCT04397523|182934264|OTHER|||||||0.05||||||p=0.00000|ANOVA|df 2||||||0.05
91529084|NCT04397523|182934269|OTHER|||||||0.05||||||Chi- square = 24.98174, p = 0.00000|Chi-squared|df = 2||Overall survival between the three WHO score groups 3, 4 and 5||||0.05
91529085|NCT04397523|182934269|OTHER|||||||0.05||||||p=0.000|Chi-squared|df = 2||Correlation of mortality versus WHO disease progression score of patients||||0.05
91529086|NCT04397523|182934269|OTHER|||||||0.05||||||p = 0.000|Chi-squared|df = 1||Correlation of mortality versus stay in the intensive care unit (ICU)||||0.05
91529087|NCT01275196|182934270|NON_INFERIORITY_OR_EQUIVALENCE|This trial was powered to detect an odds ratio of at least 2.333 which corresponds, for example, to increases of 18% (from 22% to 40%) and increases of 20% (from 30% to 50%).||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
91529088|NCT01744496|182934290|SUPERIORITY_OR_OTHER||Least Square Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.55||0.172|TWO_SIDED|95.0|-1.87|0.34|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.34|-1.87|0.172
91529089|NCT01744496|182934292|SUPERIORITY_OR_OTHER||Least Square Mean|-8.01|STANDARD_ERROR_OF_MEAN|3.77||0.038|TWO_SIDED|95.0|-15.56|-0.46|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||-0.46|-15.56|0.038
91529090|NCT01744496|182934293|SUPERIORITY_OR_OTHER||Least Square Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.87||0.247|TWO_SIDED|95.0|-2.76|0.73|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.73|-2.76|0.247
91529091|NCT01744496|182934294|SUPERIORITY_OR_OTHER||Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.64||0.371|TWO_SIDED|95.0|-1.85|0.7|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.70|-1.85|0.371
91529092|NCT01744496|182934295|SUPERIORITY_OR_OTHER||Least Square Mean|-2.82|STANDARD_ERROR_OF_MEAN|2.97||0.346|TWO_SIDED|95.0|-8.76|3.13|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||3.13|-8.76|0.346
91529093|NCT01284140|182934297|OTHER|||||||0.37|||||||Extra sum-of-squares F test|The null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was not rejected for the Usual Care group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Usual Care group.||||0.37
91529094|NCT01284140|182934297|OTHER|||||||0.0074|||||||Extra sum-of-squares F test|This result suggests that the best-fit values for amplitude and phase are different between Day 1 and Day 3 in the Sleep Promotion group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Sleep promotion group.||||0.0074
91529095|NCT01284140|182934298|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
91529096|NCT01284140|182934299|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.03|TWO_SIDED||||||t-test, 2 sided|||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. This resulted in 4 separate best-fit curves. The model parameter of amplitude was derived from the best-fit curves.||||0.03
91529097|NCT05033080|182934383|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI).|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.7|1.1|||Mixed Models Repeated Measures|||||1.1|-0.7|< 0.0001
91529098|NCT05033080|182934384|SUPERIORITY||LS Mean difference|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.5|-6.3|||Mixed Models Repeated Measures|||||-6.3|-10.5|< 0.0001
91529099|NCT05033080|182934385|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.15|||Generalized Estimated Equation Model|||||3.15|1.55|< 0.0001
91732895|NCT03863574|183360813|OTHER|Proof-of-concept||||||0.9133|||||||t-test, 2 sided|||||||0.9133
91494550|NCT04518293|182860904|OTHER||Risk Difference (RD)|12.03||||0.0004|TWO_SIDED|95.0|4.982|18.658|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||18.658|4.982|0.0004
91529100|NCT05033080|182934386|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
91529101|NCT04159415|182934415|SUPERIORITY||Least Squares (LS) Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.9|2.3|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||2.3|-1.9|
91732896|NCT03863574|183360814|OTHER|Proof-of-concept||||||0.7267|||||||t-test, 2 sided|||||||0.7267
91732897|NCT03863574|183360814|OTHER|Proof-of-concept||||||0.9211|||||||t-test, 2 sided|||||||0.9211
91732898|NCT03863574|183360815|OTHER|Proof-of-concept||||||0.8683|||||||t-test, 2 sided|||||||0.8683
91732899|NCT03863574|183360815|OTHER|Proof-of-concept||||||0.7436|||||||t-test, 2 sided|||||||0.7436
91732900|NCT04938427|183360839|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-1.17|||=|0.785|TWO_SIDED|95.0|-13.02|9.99||The p-value was calculated using Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) are based on the Hodges-Lehmann estimation.|||9.99|-13.02|=0.785
91732901|NCT04938427|183360840|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|2.43|||=|0.778|TWO_SIDED|95.0|-10.86|15.14||The p-value was calculated using the Rank ANCOVA model using the treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||15.14|-10.86|=0.778
91732902|NCT04938427|183360841|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|0.94|3.87||||||||3.87|0.94|
91732903|NCT04938427|183360842|SUPERIORITY||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.92|4.05||||||||4.05|0.92|
91732904|NCT04938427|183360844|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.86|2.13||||||||2.13|0.86|
91529102|NCT04159415|182934416|SUPERIORITY||LS Mean Difference|38.1|STANDARD_ERROR_OF_MEAN|27.3|||TWO_SIDED|95.0|-21.3|97.5|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||97.5|-21.3|
91529103|NCT04159415|182934417|SUPERIORITY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|29.0|||TWO_SIDED|95.0|-56.9|56.9|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from ANCOVA model analyses of the different imputed data sets.|||56.9|-56.9|
91732905|NCT04938427|183360845|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.89|2.21||||||||2.21|0.89|
91732906|NCT04938427|183360846|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.85|2.3||||||Alertness Domain||2.30|0.85|
91494551|NCT04518293|182860904|OTHER||Risk Difference (RD)|18.19|||<|0.0001|TWO_SIDED|95.0|11.412|24.432|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||24.432|11.412|<.0001
91494552|NCT04518293|182860905|OTHER||Risk Difference (RD)|10.45||||0.0007|TWO_SIDED|95.0|3.993|16.433|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||16.433|3.993|0.0007
91494553|NCT04518293|182860905|OTHER||Risk Difference (RD)|8.93||||0.0046|TWO_SIDED|95.0|2.337|15.058|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.058|2.337|0.0046
91529104|NCT04159415|182934418|SUPERIORITY||Adjusted Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|43.6|||TWO_SIDED|95.0|-67.6|103.2|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.|||103.2|-67.6|
91529105|NCT03560245|182934420|EQUIVALENCE|"The change from baseline to Week 13 in the SIB total score was summarized descriptively and compared using Analysis of Covariance (ANCOVA) adjusted for baseline SIB total score.~If the normality assumption was not met, a non-parametric method or a rank-ANCOVA analysis (i.e., an ANCOVA analysis on rank-transformed data) was to be used."||||||0.373|||||||t-test, 2 sided|||||||0.3730
91529106|NCT02058290|182934460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91732907|NCT04938427|183360846|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.91|2.48||||||Communication Domain||2.48|0.91|
91732908|NCT04938427|183360846|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|1.06|3.43||||||Disruptive Behaviors Domain||3.43|1.06|
91732909|NCT04938427|183360847|SUPERIORITY||Least Square Mean Difference|0.52|||||TWO_SIDED|95.0|-2.2|3.24||||||||3.24|-2.20|
91732910|NCT04938427|183360848|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.06|2.65||||||||2.65|1.06|
91732911|NCT04938427|183360849|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.37|||||TWO_SIDED|95.0|-16.83|4.16|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||4.16|-16.83|
91732912|NCT04938427|183360850|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.65|||||TWO_SIDED|95.0|-16.67|3.12|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||3.12|-16.67|
91732913|NCT04938427|183360851|SUPERIORITY||LS Mean Difference|2.47|||||TWO_SIDED|95.0|-1.74|6.67|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||6.67|-1.74|
91732914|NCT04938427|183360852|SUPERIORITY||LS Mean Difference|5.4|||||TWO_SIDED|95.0|1.9|8.9||||||||8.9|1.9|
91732915|NCT04938427|183360853|SUPERIORITY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-3.7|2.0||||||||2.0|-3.7|
91732916|NCT01107496|183360861|SUPERIORITY||Median Difference (Net)|6.0||||0.0414|TWO_SIDED|95.0|1.0|12.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||12.00|1.00|0.0414
91732917|NCT01107496|183360862|SUPERIORITY||Median Difference (Net)|3.0||||0.0803|TWO_SIDED|95.0|0.0|7.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 1 data.||7.00|0.00|0.0803
91732918|NCT01107496|183360863|SUPERIORITY||Median Difference (Net)|0.0||||0.5308|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 1 data.||1.00|-1.00|0.5308
91732919|NCT01107496|183360863|SUPERIORITY||Median Difference (Net)|-1.0||||0.2032|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 2 data.||0.00|-2.00|0.2032
91494554|NCT04518293|182860905|OTHER||Risk Difference (RD)|12.19|||<|0.0001|TWO_SIDED|95.0|5.792|18.073|||Wald test|||||18.073|5.792|<.0001
91494555|NCT04518293|182860906|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.11|STANDARD_ERROR_OF_MEAN|0.495|<|0.0001|TWO_SIDED|95.0|-7.086|-5.144|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.144|-7.086|<.0001
91529107|NCT02058290|182934461|SUPERIORITY_OR_OTHER|||||||0.2612|||||||ANOVA|||||||0.2612
91529108|NCT02058290|182934462|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
91529109|NCT02262260|182934497|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in BCVA at month 12 from the baseline visit were determined for both treatment groups, and a comparison was made between the two groups using the Independent Samples t-test."||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91529110|NCT02262260|182934498|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in Central Retinal Thickness determined with Optical Coherence Tomography for both eyes were calculated for both groups and were compared using the Mann Whitney u test."||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
91529111|NCT02262260|182934501|NON_INFERIORITY|Comparison was made between the two groups using the Independent Samples t-test.||||||0.095|||||||Chi-squared|||||||0.095
91529112|NCT02262260|182934502|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test.||||||0.072|||||||Chi-squared|||||||0.072
91529113|NCT02262260|182934503|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test||||||0.466|||||||Chi-squared|||||||0.466
91529114|NCT01794117|182934506|SUPERIORITY|||||||0.033|||||||Wilcoxon Signed Rank Test|||||||0.033
91529115|NCT01233609|182934637|SUPERIORITY||Mean Difference (Net)|-150.43|STANDARD_ERROR_OF_MEAN|71.37||0.035|TWO_SIDED||||||Mixed Models Analysis|degrees of freedom = 830|Right eye and Left Eye within each of the 2 treatment groups (Placebo and Valproic Acid) were combined to estimate the difference|||||0.035
91529116|NCT01233609|182934638|SUPERIORITY|||||||0.581|||||||Mixed Models Analysis|||||||0.581
91529117|NCT01233609|182934639|SUPERIORITY|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
91529118|NCT01233609|182934640|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
91529119|NCT03677128|182934674|OTHER||Mean Difference (Final Values)|23.8|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91529120|NCT03677128|182934674|OTHER||Mean Difference (Final Values)|21.1|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91529121|NCT04834362|182934689|OTHER|||||||0.677|||||||t-test, 2 sided|||||||0.677
91529122|NCT04834362|182934690|OTHER|||||||0.053|||||||t-test, 2 sided|||||||0.053
91529123|NCT04834362|182934691|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
91529124|NCT04834362|182934692|OTHER|||||||0.729|||||||Chi-squared|||||||0.729
91529125|NCT02802020|182934715|SUPERIORITY|||||||0.999|||||||Fisher Exact|||"We hypothesized that pain reduction (as defined in Study endpoints above) would be achieved in a performance goal of at least 53% of patients receiving the study SEMS. Assuming an observed pain reduction rate of 75% and using an exact test with a one-sided alpha of 0.025, 43 patients were required to obtain power of at least 80%."||||0.999
91529126|NCT02802020|182934716|SUPERIORITY|we hypothesized that the proportion of patients reporting one or more related SAE(s) would be below a performance goal of 32%. Assuming an observed SAE rate of 15% and using an exact test with one-sided alpha of 0.025, 57 patients were required to obtain power of at least 80%.||||||0.513|||||||Fisher Exact|||||||0.513
91529127|NCT00883103|182934767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91529128|NCT03954158|182934810|SUPERIORITY||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.53||0.0071|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.7|0.0071
91529129|NCT03954158|182934810|SUPERIORITY||Least squares mean of difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0029|TWO_SIDED|95.0|-3.3|-0.8|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.8|-3.3|0.0029
91529130|NCT03954158|182934810|SUPERIORITY||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.025|TWO_SIDED|95.0|-2.7|-0.2|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|0.0250
91529131|NCT03954158|182934810|SUPERIORITY||Least squares mean of difference|-2.1|STANDARD_ERROR_OF_MEAN|0.56||0.0014|TWO_SIDED|95.0|-3.3|-0.9|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.9|-3.3|0.0014
91494556|NCT04518293|182860906|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.543|<|0.0001|TWO_SIDED|95.0|-4.06|-1.932|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.932|-4.060|<.0001
91494557|NCT04518293|182860906|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.09|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-6.274|-3.912|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.912|-6.274|<.0001
91494558|NCT04518293|182860907|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.364|<|0.0001|TWO_SIDED|95.0|-4.069|-2.632|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.632|-4.069|<.0001
91529132|NCT03954158|182934811|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.4295|||TWO_SIDED|95.0|-2.0|0.9||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.9|-2.0|
91529133|NCT03954158|182934811|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.4|-2.1|
91529134|NCT03954158|182934812|OTHER||Least squares mean of difference|-1.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.1|-0.7||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.7|-3.1|
91529135|NCT03954158|182934812|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-2.7|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|
91529136|NCT03954158|182934812|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.2|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.2|
91529137|NCT03954158|182934812|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-2.8|-0.5||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.8|
91529138|NCT03954158|182934812|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.3||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.3|-1.5|
91529139|NCT03954158|182934812|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.2|1.0||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.0|-1.2|
91529140|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.9|-0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.1|-0.9|
91529141|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.9|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.9|
91529142|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.1|-0.8|
91529143|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.8|
91529144|NCT03954158|182934813|OTHER||Difference of least square mean|0.1|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.4|0.6||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.4|
91529145|NCT03954158|182934813|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.3|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.7|-0.3|
91529146|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-1.4|-0.4||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.4|-1.4|
91529147|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
91529148|NCT03954158|182934813|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
91529149|NCT03954158|182934813|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.4|-0.6||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.6|-1.4|
91529150|NCT03954158|182934813|OTHER||Difference of least square mean|0.0|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.5|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.5|
91529151|NCT03954158|182934813|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.5|-0.7|
91529152|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.2|-1.0|
91529153|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.5|-0.7|
91529154|NCT03954158|182934814|OTHER||Difference of least squares mean|0.6|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.5|1.7||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.7|-0.5|
91529155|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
91529156|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.9|0.4||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-0.9|
91494559|NCT04518293|182860907|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.456|<|0.0001|TWO_SIDED|95.0|-2.998|-1.2|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.200|-2.998|<.0001
91529157|NCT03954158|182934814|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-0.9|1.3||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.9|
91732920|NCT01107496|183360863|SUPERIORITY||Median Difference (Net)|-1.0||||0.0677|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 3 data.||0.00|-2.00|0.0677
91732921|NCT01107496|183360863|SUPERIORITY||Median Difference (Net)|-1.0||||0.0743|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 4 data.||0.00|-2.00|0.0743
91732922|NCT01107496|183360863|SUPERIORITY||Median Difference (Net)|-1.0||||0.0437|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 5 data.||0.00|-2.00|0.0437
91732923|NCT01107496|183360863|SUPERIORITY||Median Difference (Net)|-1.0||||0.1209|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||0.00|-2.00|0.1209
91732924|NCT01107496|183360864|SUPERIORITY||Median Difference (Net)|1.0||||0.6022|TWO_SIDED|95.0|-4.0|6.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 2 data.||6.00|-4.00|0.6022
91732925|NCT01107496|183360864|SUPERIORITY||Median Difference (Net)|-4.0||||0.0794|TWO_SIDED|95.0|-10.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 3 data.||1.00|-10.0|0.0794
91732926|NCT01107496|183360864|SUPERIORITY||Median Difference (Net)|-6.0||||0.0747|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 4 data.||0.00|-10.0|0.0747
91732927|NCT01107496|183360864|SUPERIORITY||Median Difference (Net)|-6.5||||0.0545|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 5 data.||0.00|-12.0|0.0545
91732928|NCT01107496|183360865|SUPERIORITY||Median Difference (Net)|7.0||||0.0349|TWO_SIDED|95.0|1.0|13.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||13.00|1.00|0.0349
91732929|NCT01107496|183360866|SUPERIORITY||Median Difference (Net)|-0.5||||0.4038|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 1 data||0.00|-1.00|0.4038
91494560|NCT04518293|182860907|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.63|STANDARD_ERROR_OF_MEAN|0.499|<|0.0001|TWO_SIDED|95.0|-4.617|-2.649|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.649|-4.617|<.0001
91529158|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.1|-0.5||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.1|
91529159|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
91732930|NCT01107496|183360866|SUPERIORITY||Median Difference (Net)|-0.5||||0.446|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 2 data||0.00|-1.00|0.4460
91732931|NCT01107496|183360866|SUPERIORITY||Median Difference (Net)|-0.5||||0.0549|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 3 data||0.00|-1.00|0.0549
91732932|NCT01107496|183360866|SUPERIORITY||Median Difference (Net)|-0.5||||0.0759|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 4 data||0.00|-1.00|0.0759
91494561|NCT04518293|182860908|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-3.52|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-4.137|-2.908|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.908|-4.137|<.0001
91494562|NCT04518293|182860908|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.361|<|0.0001|TWO_SIDED|95.0|-2.803|-1.376|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.376|-2.803|<.0001
91732933|NCT01107496|183360866|SUPERIORITY||Median Difference (Net)|-0.5||||0.0342|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 5 data||0.00|-1.00|0.0342
91732934|NCT01107496|183360866|SUPERIORITY||Median Difference (Net)|-1.0||||0.0474|TWO_SIDED||||||Wilcoxon rank-sum test|||Analysis pertains to Week 6 data||||0.0474
91732935|NCT02496000|183360869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0117|||||||Kruskal-Wallis|ANOVA model on the ranks||This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.||||0.0117
91732936|NCT01877278|183360874|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91732937|NCT01877278|183360874|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
91732938|NCT01877278|183360875|SUPERIORITY_OR_OTHER||||||=|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||=0.0001
91732939|NCT01877278|183360875|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
91732940|NCT01969058|183360876|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.||||0.030
91732941|NCT04262479|183360918|OTHER||||||||||||||||||Counting number of events.|||
91732942|NCT04262479|183360919|OTHER||||||||||||||||||Counting number of events|||
91732943|NCT04262479|183360920|OTHER||||||<|0.001||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.001
91732944|NCT04262479|183360921|OTHER||||||<|0.05||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.05
91732945|NCT04262479|183360922|OTHER||||||<|0.61||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.61
91732946|NCT04262479|183360923|OTHER||||||<|0.3||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.30
91732947|NCT04262479|183360924|OTHER||||||<|0.002||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.002
91732948|NCT04262479|183360925|OTHER||||||<|0.72||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.72
91732949|NCT04262479|183360926|OTHER||||||<|0.03||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.03
91494563|NCT04518293|182860908|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.58|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-4.446|-2.713|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.713|-4.446|<.0001
91494564|NCT04518293|182860909|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-5.58|STANDARD_ERROR_OF_MEAN|0.713|<|0.0001|TWO_SIDED|95.0|-6.983|-4.169|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.169|-6.983|<.0001
91494565|NCT04518293|182860909|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.662||0.0043|TWO_SIDED|95.0|-3.218|-0.607|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-0.607|-3.218|0.0043
91529160|NCT03954158|182934814|OTHER||Difference of least square mean|0.4|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.6|1.4||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.4|-0.6|
91494566|NCT04518293|182860909|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.74|STANDARD_ERROR_OF_MEAN|0.745|<|0.0001|TWO_SIDED|95.0|-5.214|-2.274|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-2.274|-5.214|<.0001
91494567|NCT04518293|182860910|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.25|STANDARD_ERROR_OF_MEAN|0.546|<|0.0001|TWO_SIDED|95.0|-7.324|-5.168|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.168|-7.324|<.0001
91494568|NCT04518293|182860910|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.72|STANDARD_ERROR_OF_MEAN|0.616|<|0.0001|TWO_SIDED|95.0|-3.941|-1.507|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.507|-3.941|<.0001
91529161|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.9|-0.3||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.9|
91732950|NCT04262479|183360927|OTHER||||||<|0.044||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.044
91732951|NCT00791648|183360966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Pearson x2|||||||.75
91529162|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
91529163|NCT03954158|182934814|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.1|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.0|-1.1|
91529164|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.1|-0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.4|-2.1|
91529165|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.1|0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-1.1|
91529166|NCT03954158|182934814|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.6|1.5||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.5|-0.6|
91529167|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.3|
91529168|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.2|-1.0|
91529169|NCT03954158|182934814|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.6|1.3||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.6|
91529170|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.0|-0.3||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-2.0|
91529171|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
91529172|NCT03954158|182934814|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.6|1.2||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.2|-0.6|
91529173|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.4|-0.9||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.4|
91529174|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.7|-1.5|
91529175|NCT03954158|182934814|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.7|1.6||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.6|-0.7|
91529176|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-2.3|-0.9||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.3|
91529177|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.1|
91529178|NCT03954158|182934814|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.8|
91529179|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.7|0.0||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-1.7|
91529180|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.3|-0.7||||||Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.||-0.7|-2.3|
91732952|NCT00791648|183360967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||.56
91732953|NCT00791648|183360968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
91732954|NCT00791648|183360969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||.11
91732955|NCT00791648|183360970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
91732956|NCT00791648|183360971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
91759232|NCT00348309|183411451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||=|0.566|TWO_SIDED|95.0|-2.9|1.6||Week 48|Mixed Models Analysis|||||1.6|-2.9|=0.566
91494569|NCT04518293|182860910|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-4.43|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-5.489|-3.368|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.368|-5.489|<.0001
91494570|NCT04518293|182860911|OTHER||Risk Difference (RD)|14.79|||<|0.0001|TWO_SIDED|95.0|7.749|21.824|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||21.824|7.749|<.0001
91494571|NCT04518293|182860911|OTHER||Risk Difference (RD)|8.46||||0.0146|TWO_SIDED|95.0|1.58|15.501|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||15.501|1.580|0.0146
91529181|NCT03954158|182934814|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.7|1.1||||||Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.1|-0.7|
91529182|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.0|-0.5||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.0|
91732957|NCT03396445|183360990|OTHER||Difference in Percent|6.2|||||TWO_SIDED|95.0|-21.2|32.8|||||Comparison based on Miettinen \& Nurminen method|Difference in percentage of participants who experienced a CR or PR (Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W \[Endometrial\] - Arm 1a Boserolimab 30 mg Q3W \[Endometrial\])||32.8|-21.2|
91732958|NCT03396445|183360990|OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|95.0|-32.1|17.2|||||Comparison based on Miettinen \& Nurminen method|Difference in percentage of participants who experienced a CR or PR (Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W \[Endometrial\] - Arm 1a Boserolimab 30 mg \[Endometrial\])||17.2|-32.1|
91732959|NCT03396445|183360990|OTHER||Difference in Percentage|13.3|||||TWO_SIDED|95.0|-11.7|38.4|||||Comparison based on Miettinen \& Nurminen method|Difference in percentage of participants who experienced a CR or PR (Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W \[Endometrial\] - Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W \[Endometrial\])||38.4|-11.7|
91732960|NCT02964377|183360995|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0482|||||||t-test, 2 sided|||||||0.0482
91732961|NCT02964377|183360995|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0075|||||||t-test, 2 sided|||||||0.0075
91732962|NCT02964377|183360995|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0083|||||||t-test, 2 sided|||||||0.0083
91732963|NCT02964377|183360996|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0127|||||||t-test, 2 sided|||||||0.0127
91732964|NCT02964377|183360996|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0202|||||||t-test, 2 sided|||||||0.0202
91732965|NCT02964377|183360996|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0007|||||||t-test, 2 sided|||||||0.0007
91732966|NCT02964377|183360997|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 1)||||<0.0001
91732967|NCT02964377|183360997|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 2)||||<0.0001
91494572|NCT04518293|182860911|OTHER||Risk Difference (RD)|16.07|||<|0.0001|TWO_SIDED|95.0|8.953|23.171|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||23.171|8.953|<.0001
91494573|NCT04518293|182860912|OTHER||Risk Difference (RD)|18.11|||<|0.0001|TWO_SIDED|95.0|10.778|25.226|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.226|10.778|<.0001
91529183|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-2.0|
91529184|NCT03954158|182934814|OTHER||Difference of Least Squares Mean|0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.9|1.2||||||Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.9|
91732968|NCT02964377|183360997|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 3)||||<0.0001
91732969|NCT02964377|183360997|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 1)||||<0.0001
91494574|NCT04518293|182860912|OTHER||Risk Difference (RD)|6.64||||0.0674|TWO_SIDED|95.0|-0.613|13.926|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||13.926|-0.613|0.0674
91732970|NCT02964377|183360997|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 2)||||<0.0001
91732971|NCT02964377|183360997|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 3)||||<0.0001
91732972|NCT02964377|183361000|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 4||||0.002
91732973|NCT02964377|183361000|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.001
91732974|NCT02964377|183361000|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732975|NCT02964377|183361000|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732976|NCT02964377|183361000|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732977|NCT02964377|183361000|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732978|NCT02964377|183361001|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732979|NCT02964377|183361001|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732980|NCT02964377|183361001|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91529185|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.8|-0.3||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.8|
91732981|NCT02964377|183361001|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732982|NCT02964377|183361001|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732983|NCT02964377|183361001|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732984|NCT02964377|183361002|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732985|NCT02964377|183361002|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732986|NCT02964377|183361002|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732987|NCT02964377|183361002|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732988|NCT02964377|183361002|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732989|NCT02964377|183361002|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732990|NCT02964377|183361003|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.012|||||||Regression, Linear|||Baseline vs. Week 4||||0.012
91732991|NCT02964377|183361003|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732992|NCT02964377|183361003|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
91732993|NCT02964377|183361003|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 8||||0.01
91732994|NCT02964377|183361003|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732995|NCT02964377|183361003|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
91732996|NCT02964377|183361005|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 4||||0.01
91529186|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|-0.1||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.0|
91732997|NCT02964377|183361005|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.019|||||||Regression, Linear|||Baseline vs. Week 4||||0.019
91732998|NCT02964377|183361005|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.001
91732999|NCT02964377|183361005|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.05|||||||Regression, Linear|||Baseline vs. Week 8||||0.05
91733000|NCT02964377|183361006|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.054||||||p-value for difference at Week 4|Regression, Linear|||Baseline vs. Week 8||||0.054
91733001|NCT02964377|183361006|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.009|||||||Regression, Linear|||Baseline vs. Week 4||||0.009
91733002|NCT02964377|183361007|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.025|||||||Regression, Linear|||Baseline vs. Week 8||||0.025
91733003|NCT02964377|183361007|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.026|||||||Regression, Linear|||Baseline vs. Week 4||||0.026
91733004|NCT02964377|183361008|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.006|||||||Regression, Linear|||Baseline vs. Week 4||||0.006
91733005|NCT02964377|183361008|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 8||||0.002
91733006|NCT00836706|183361015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|85.2|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|85.2|
91733007|NCT00836706|183361016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.7|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.7|
91733008|NCT00836706|183361017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.4|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.4|
91733009|NCT02989857|183361018|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.54||P-value was calculated from the one-sided stratified log-rank test.|Log Rank||Hazard ratio was calculated from stratified Cox regression model with placebo as the denominator, with two-sided 95% confidence interval.|||0.54|0.25|<0.0001
91733010|NCT02989857|183361025|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.093|TWO_SIDED|95.0|0.56|1.12||P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||1.12|0.56|0.093
91733011|NCT02989857|183361026|SUPERIORITY|||||||0.466||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.466
91733012|NCT02989857|183361027|SUPERIORITY|||||||0.299||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.299
91733013|NCT02989857|183361032|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68||P-value was calculated from one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the denominator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||0.68|0.33|<0.0001
91733014|NCT02989857|183361033|OTHER||Least-squares mean difference|11.0|||||TWO_SIDED|95.0|4.23|17.73||||||Cycle 2 Day 1: Physical Functioning||17.73|4.23|
91494575|NCT04518293|182860912|OTHER||Risk Difference (RD)|18.23|||<|0.0001|TWO_SIDED|95.0|10.839|25.392|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||25.392|10.839|<.0001
91733015|NCT02989857|183361033|OTHER||Least-squares mean difference|-10.4|||||TWO_SIDED|95.0|-20.18|-0.52||||||Cycle 2 Day 1: Pain||-0.52|-20.18|
91733016|NCT02989857|183361033|OTHER||Least-squares mean difference|3.6|||||TWO_SIDED|95.0|-6.65|13.91||||||Cycle 2 Day 1: Appetite Loss||13.91|-6.65|
91733017|NCT02989857|183361033|OTHER||Least-squares mean difference|12.3|||||TWO_SIDED|95.0|3.85|20.78||||||Cycle 3 Day 1: Physical Functioning||20.78|3.85|
91733018|NCT02989857|183361033|OTHER||Least-squares mean difference|4.1|||||TWO_SIDED|95.0|-8.74|17.04||||||Cycle 3 Day 1: Pain||17.04|-8.74|
91733019|NCT02989857|183361033|OTHER||Least-squares mean difference|-3.7|||||TWO_SIDED|95.0|-17.46|10.11||||||Cycle 3 Day 1: Appetite Loss||10.11|-17.46|
91494576|NCT04518293|182860913|OTHER||Risk Difference (RD)|17.25|||<|0.0001|TWO_SIDED|95.0|9.902|24.286|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||24.286|9.902|<.0001
91733020|NCT02989857|183361034|OTHER||Least-squares mean difference|-5.1|||||TWO_SIDED|95.0|-12.93|2.8||||||Cycle 2 Day 1: Pain||2.80|-12.93|
91733021|NCT02989857|183361034|OTHER||Least-squares mean difference|0.7|||||TWO_SIDED|95.0|-6.56|7.88||||||Cycle 2 Day 1: Appetite Loss||7.88|-6.56|
91733022|NCT02989857|183361034|OTHER||Least-squares mean difference|4.4|||||TWO_SIDED|95.0|-5.82|14.55||||||Cycle 3 Day 1: Pain||14.55|-5.82|
91733023|NCT02989857|183361034|OTHER||Least-squares mean difference|-6.1|||||TWO_SIDED|95.0|-15.34|3.12||||||Cycle 3 Day 1: Appetite Loss||3.12|-15.34|
91733024|NCT02541591|183361063|SUPERIORITY||Median ratio of final values|1.37||||0.0881|TWO_SIDED|95.0|0.95|1.98|||ANOVA|due to non normality of the residuals the data were log-transformed prior to the anova|the estimated mean difference obtained using the anova on the log-transformed data was back transformed thus yielding a ratio of median values|missing data were accounted for by multiple imputation||1.98|0.95|0.0881
91733025|NCT00123630|183361077|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91733026|NCT01098747|183361086|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|24.21|||<|0.001|TWO_SIDED|95.0|19.32|29.09||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||29.09|19.32|<0.001
91733027|NCT01098747|183361087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.8|||<|0.001|TWO_SIDED|95.0|6.78|24.15||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||24.15|6.78|<0.001
91733028|NCT01098747|183361087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.001|TWO_SIDED|95.0|1.22|2.06||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||2.06|1.22|<0.001
91494577|NCT04518293|182860913|OTHER||Risk Difference (RD)|12.06||||0.001|TWO_SIDED|95.0|4.632|19.293|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||19.293|4.632|0.0010
91494578|NCT04518293|182860913|OTHER||Risk Difference (RD)|22.93|||<|0.0001|TWO_SIDED|95.0|15.622|29.796|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||29.796|15.622|<.0001
91494579|NCT04518293|182860914|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.579|25.124|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.124|11.579|<.0001
91494580|NCT04518293|182860914|OTHER||Risk Difference (RD)|12.22||||0.0005|TWO_SIDED|95.0|4.963|19.123|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||19.123|4.963|0.0005
91733029|NCT01098747|183361088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.36|||<|0.001|TWO_SIDED|95.0|6.51|23.46||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||23.46|6.51|<0.001
91733030|NCT01098747|183361088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|||<|0.001|TWO_SIDED|95.0|1.38|2.34||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.34|1.38|<0.001
91733031|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|0.35||||0.007|TWO_SIDED|95.0|0.1|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.10|0.007
91733032|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.01|TWO_SIDED|95.0|0.06|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.42|0.06|0.010
91494581|NCT04518293|182860914|OTHER||Risk Difference (RD)|16.2|||<|0.0001|TWO_SIDED|95.0|9.06|22.914|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||22.914|9.060|<.0001
91529187|NCT03954158|182934814|OTHER||Difference of Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.3|0.9||||||Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.9|-1.3|
91529188|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.9|-0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-1.9|
91529189|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.1||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.8|
91529190|NCT03954158|182934814|OTHER||Difference of Least Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.7|-1.5|
91529191|NCT03954158|182934814|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.2|-0.8||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.8|-2.2|
91529192|NCT03954158|182934814|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.5|0.0||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-1.5|
91529193|NCT03954158|182934814|OTHER||Difference of least square mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.4|0.8||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||0.8|-1.4|
91529194|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.2|-1.0|
91529195|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
91529196|NCT03954158|182934815|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.5|1.1||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.1|-0.5|
91529197|NCT03954158|182934815|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.7||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.6|
91529198|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
91529199|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
91494582|NCT04518293|182860915|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-1.529|2.768||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TA arms.||2.768|-1.529|
91494583|NCT04518293|182860915|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TI arms.||2.475|-2.098|
91529200|NCT03954158|182934815|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|96.0|-1.1|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.1|
91529201|NCT03954158|182934815|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.8|-0.8|
91529202|NCT03954158|182934815|OTHER||Difference of least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-0.9|0.8||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.9|
91529203|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.2|0.3||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.2|
91529204|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
91494584|NCT04518293|182860915|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-AI arms.||2.475|-2.098|
91494585|NCT04518293|182860921|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.07|||||TWO_SIDED|95.0|0.494|7.116||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||7.116|0.494|
91494586|NCT04518293|182860921|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-3.927|4.02||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||4.020|-3.927|
91494587|NCT04518293|182860921|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.64|||||TWO_SIDED|95.0|-0.07|6.764||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||6.764|-0.070|
91529205|NCT03954158|182934815|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.8|
91494588|NCT04518293|182860922|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.59|||||TWO_SIDED|95.0|-0.5|5.136||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.136|-0.500|
91494589|NCT04518293|182860922|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
91529206|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
91529207|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-0.9|
91529208|NCT03954158|182934815|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
91529209|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.0|0.9||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.9|-1.0|
91529210|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.7||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-1.0|
91529211|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.2|
91529212|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.3|0.5||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.3|
91494590|NCT04518293|182860922|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.73|||||TWO_SIDED|95.0|-2.855|3.633||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||3.633|-2.855|
91494591|NCT04518293|182860923|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06|||||TWO_SIDED|95.0|-3.911|3.129||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||3.129|-3.911|
91494592|NCT04518293|182860923|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53|||||TWO_SIDED|95.0|-4.519|2.744||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.744|-4.519|
91494593|NCT04518293|182860923|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-3.228|3.647||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||3.647|-3.228|
91529213|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.4|0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.4|
91529214|NCT03954158|182934815|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
91529215|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
91529216|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
91759233|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||=|0.414|TWO_SIDED|95.0|-1.3|0.5||Week 8|Mixed Models Analysis|||||0.5|-1.3|=0.414
91494594|NCT04518293|182860924|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-3.993|2.816||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||2.816|-3.993|
91733033|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|1.47|||<|0.001|TWO_SIDED|95.0|1.1|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.||1.84|1.10|<0.001
91733034|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.27|0.8||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.80|0.27|<0.001
91759234|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.931|TWO_SIDED|95.0|-1.0|1.1||Week 8|Mixed Models Analysis|||||1.1|-1.0|0.931
91494595|NCT04518293|182860924|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
91494596|NCT04518293|182860924|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.72|||||TWO_SIDED|95.0|-4.596|2.44||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||2.440|-4.596|
91494597|NCT04518293|182860925|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|6.72|||||TWO_SIDED|95.0|4.196|9.222||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||9.222|4.196|
91494598|NCT04518293|182860925|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.883|5.257||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||5.257|-1.883|
91494599|NCT04518293|182860925|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-5.97|||||TWO_SIDED|95.0|-10.979|-1.6||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||-1.600|-10.979|
91494600|NCT04518293|182860926|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.13|||||TWO_SIDED|95.0|0.123|5.632||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.632|0.123|
91494601|NCT04518293|182860926|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-2.245|4.134||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.134|-2.245|
91494602|NCT04518293|182860926|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.71|||||TWO_SIDED|95.0|-6.968|0.819||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||0.819|-6.968|
91494603|NCT04518293|182860927|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.863|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||2.231|-0.863|
91494604|NCT04518293|182860927|OTHER||Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.897|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.231|-0.897|
91494605|NCT04518293|182860927|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-1.494|1.913||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||1.913|-1.494|
91494606|NCT04518293|182860928|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-1.931|1.149||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||1.149|-1.931|
91494607|NCT04518293|182860928|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.979|1.143||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||1.143|-1.979|
91494608|NCT04518293|182860928|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-1.374|1.453||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||1.453|-1.374|
91494609|NCT04518293|182860929|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.39|||||TWO_SIDED|95.0|-2.014|2.087||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TA arms.||2.087|-2.014|
91494610|NCT04518293|182860929|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TI arms.||2.633|-1.015|
91494611|NCT04518293|182860929|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-AI arms.||2.633|-1.015|
91494612|NCT04518293|182860930|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-2.501|1.385||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TA arms.||1.385|-2.501|
91733035|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|2.22|||<|0.001|TWO_SIDED|95.0|1.84|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.84|<0.001
91733036|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.006|TWO_SIDED|95.0|0.12|0.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.66|0.12|0.006
91733037|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.77||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.77|2.00|<0.001
91733038|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.022|TWO_SIDED|95.0|0.05|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.05|0.022
91733039|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.79|2.00|<0.001
91733040|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|0.13||||0.369|TWO_SIDED|95.0|-0.15|0.41||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.41|-0.15|0.369
91494613|NCT04518293|182860930|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.54|||||TWO_SIDED|95.0|-3.078|1.108||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TI arms.||1.108|-3.078|
91529217|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-1.2|0.1||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.1|-1.2|
91529218|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.3|0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-1.3|
91529219|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.6|-1.0|
91529220|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.8|0.5||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-0.8|
91529221|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.6|0.3||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.6|
91529222|NCT03954158|182934815|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.4|1.0||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.4|
91529223|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
91529224|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-1.9|
91529225|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
91529226|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
91529227|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.5|0.4||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.5|
91529228|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
91529229|NCT03954158|182934815|OTHER||Least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.1|0.3||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.3|-1.1|
91529230|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.4|0.4||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.4|
91529231|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
91733041|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|2.19|||<|0.001|TWO_SIDED|95.0|1.78|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.78|<0.001
91494614|NCT04518293|182860930|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.18|||||TWO_SIDED|95.0|-2.571|1.37||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-AI arms.||1.370|-2.571|
91529232|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
91529233|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
91529234|NCT03954158|182934815|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
91529235|NCT03954158|182934815|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
91529236|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.9|
91494615|NCT04518293|182860931|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|10.55|||||TWO_SIDED|95.0|5.422|15.138||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TA arms.||15.138|5.422|
91494616|NCT04518293|182860931|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.11|||||TWO_SIDED|95.0|-2.776|8.49||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TI arms.||8.490|-2.776|
91733042|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.42|TWO_SIDED|95.0|-0.42|0.17||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.17|-0.42|0.420
91733043|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|2.02|||<|0.001|TWO_SIDED|95.0|1.58|2.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.45|1.58|<0.001
91733044|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.151|TWO_SIDED|95.0|-0.54|0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.08|-0.54|0.151
91733045|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.33|1.43|<0.001
91494617|NCT04518293|182860931|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.807|4.174||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-AI arms.||4.174|-7.807|
91529237|NCT03954158|182934816|OTHER||Least squares mean of difference|0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.6|1.0||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-0.6|
91733046|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.16|TWO_SIDED|95.0|-0.56|0.09||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.09|-0.56|0.160
91733047|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.16|2.1||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.10|1.16|<0.001
91733048|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.055|TWO_SIDED|95.0|-0.67|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.01|-0.67|0.055
91733049|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|0.91|1.88||p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.88|0.91|<0.001
91733050|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|-0.37||||0.04|TWO_SIDED|95.0|-0.71|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.02|-0.71|0.040
91733051|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.71|1.69||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.69|0.71|<0.001
91733052|NCT01098747|183361089|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.015|TWO_SIDED|95.0|-0.79|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.08|-0.79|0.015
91733053|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||<|0.001|TWO_SIDED|95.0|0.13|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.13|<0.001
91759235|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.485|TWO_SIDED|95.0|-1.4|0.7||Week 16|Mixed Models Analysis|||||0.7|-1.4|0.485
91494618|NCT04518293|182860932|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|5.47|||||TWO_SIDED|95.0|0.531|9.867||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TA arms.||9.867|0.531|
91494619|NCT04518293|182860932|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.92|||||TWO_SIDED|95.0|-0.136|9.397||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TI arms.||9.397|-0.136|
91494620|NCT04518293|182860932|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.299|3.567||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-AI arms.||3.567|-7.299|
91494621|NCT04518293|182860933|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06||||0.9677|TWO_SIDED|95.0|-3.825|3.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.019|-3.825|0.9677
91529238|NCT03954158|182934816|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-0.8|
91529239|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
91529240|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-1.5|1.0||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-1.5|
91529241|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.6|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.6|
91529242|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.1|0.8||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.8|-1.1|
91529243|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.5|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.5|
91494622|NCT04518293|182860933|OTHER||Risk Difference (RD)|-2.35||||0.1952|TWO_SIDED|95.0|-6.55|1.125|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TI arms.||1.125|-6.550|0.1952
91529244|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.4|0.6||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-2.4|
91529245|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-2.2|-0.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.5|-2.2|
91529246|NCT03954158|182934816|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.3|1.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.5|-1.3|
91529247|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.7|1.2||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-1.7|
91529248|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
91529249|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-1.4|0.5||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.4|
91494623|NCT04518293|182860933|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53||||0.7453|TWO_SIDED|95.0|-4.428|2.642|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-AI arms.||2.642|-4.428|0.7453
91494624|NCT04518293|182860934|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.12||||0.9415|TWO_SIDED|95.0|-3.657|3.222|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TA arms.||3.222|-3.657|0.9415
91494625|NCT04518293|182860934|OTHER||Risk Difference (RD)|-2.53||||0.1719|TWO_SIDED|95.0|-6.799|1.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TI arms.||1.019|-6.799|0.1719
91529250|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-1.7|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-1.7|
91529251|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.0|-0.2||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.0|
91529252|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.1|
91759236|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5||Week 16|Mixed Models Analysis|||||1.5|-0.8|0.550
91733054|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|0.11|<0.001
91733055|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.7|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.70|<0.001
91733056|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.38|||<|0.001|TWO_SIDED|95.0|0.2|0.55||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|0.20|<0.001
91494626|NCT04518293|182860934|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.16||||0.2342|TWO_SIDED|95.0|-6.38|1.326|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-AI arms.||1.326|-6.380|0.2342
91733057|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.18|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.75|1.18|<0.001
91733058|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.017|TWO_SIDED|95.0|0.04|0.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|0.04|0.017
91733059|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.39|1.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.96|1.39|<0.001
91733060|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.015|TWO_SIDED|95.0|0.05|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.05|0.015
91733061|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.41|1.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.98|1.41|<0.001
91733062|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.362|TWO_SIDED|95.0|-0.11|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.11|0.362
91494627|NCT04518293|182860935|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.87||||0.3548|TWO_SIDED|95.0|-9.316|3.215|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.215|-9.316|0.3548
91494628|NCT04518293|182860935|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.94||||0.7529|TWO_SIDED|95.0|-5.356|6.8|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TI arms.||6.800|-5.356|0.7529
91494629|NCT04518293|182860935|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.32||||0.4563|TWO_SIDED|95.0|-8.791|3.772|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-AI arms.||3.772|-8.791|0.4563
91494630|NCT04518293|182860936|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.11||||0.9691|TWO_SIDED|95.0|-6.063|5.859|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TA arms.||5.859|-6.063|0.9691
91494631|NCT04518293|182860936|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-3.59||||0.2454|TWO_SIDED|95.0|-10.018|2.462|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TI arms.||2.462|-10.018|0.2454
91494632|NCT04518293|182860936|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.33||||0.913|TWO_SIDED|95.0|-6.583|5.488|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-AI arms.||5.488|-6.583|0.9130
91494633|NCT02446483|182860945|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|101.32|||||TWO_SIDED|90.0|95.81|107.15||||||||107.15|95.81|
91494634|NCT02446483|182860946|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.71|||||TWO_SIDED|90.0|92.54|105.28||||||Comparison of T- rabeprazole 20 mg and R- rabeprazole 20 mg for AUC0-t.||105.28|92.54|
91733063|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.56|||<|0.001|TWO_SIDED|95.0|1.27|1.86||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.86|1.27|<0.001
91733064|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.472|TWO_SIDED|95.0|-0.29|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.29|0.472
91733065|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|1.07|1.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.70|1.07|<0.001
91733066|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.134|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.134
91733067|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.31|||<|0.001|TWO_SIDED|95.0|1.0|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|1.00|<0.001
91733068|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.135
91733069|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.84|1.5||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.84|<0.001
91733070|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.036|TWO_SIDED|95.0|-0.49|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-0.49|0.036
91733071|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.61|<0.001
91733072|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.064|TWO_SIDED|95.0|-0.46|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.01|-0.46|0.064
91733073|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.18|0.52|<0.001
91733074|NCT01098747|183361090|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.074|TWO_SIDED|95.0|-0.46|0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.02|-0.46|0.074
91733075|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.26|1.04||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.04|0.26|0.001
91759237|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.264|TWO_SIDED|95.0|-1.8|0.5||Week 24|Mixed Models Analysis|||||0.5|-1.8|0.264
91759238|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.732|TWO_SIDED|95.0|-1.5|1.0||Week 24|Mixed Models Analysis|||||1.0|-1.5|0.732
91759239|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.043|TWO_SIDED|95.0|-2.9|0.0||Week 48|Mixed Models Analysis|||||-0.0|-2.9|0.043
91759240|NCT00348309|183411452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.814|TWO_SIDED|95.0|-1.4|1.8||Week 48|Mixed Models Analysis|||||1.8|-1.4|0.814
91759241|NCT00348309|183411453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.870
91759242|NCT00348309|183411453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.617
91494635|NCT02446483|182860946|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.05|||||TWO_SIDED|90.0|91.81|104.71||||||Comparison of Treatment A- rabeprazole 20 mg and Treatment B- rabeprazole 20 mg for AUC0-infinity.||104.71|91.81|
91529253|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.6||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.9|
91529254|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
91733076|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.75|0.18|0.001
91733077|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|2.41|||<|0.001|TWO_SIDED|95.0|1.82|3.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.01|1.82|<0.001
91733078|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|0.91|||<|0.001|TWO_SIDED|95.0|0.48|1.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.34|0.48|<0.001
91733079|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|3.03|4.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.33|3.03|<0.001
91529255|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.4|-0.2||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.4|
91529256|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.9|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.7|-1.9|
91529257|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.3|
91529258|NCT03954158|182934816|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.9|0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-1.9|
91494636|NCT02446483|182860947|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||Wilcoxon's Signed-Rank Test|||||||0.0029
91494637|NCT04545385|182860981|OTHER||Odds Ratio (OR)|1.49||||0.7817|TWO_SIDED|95.0|0.545|4.071|||Regression, Logistic|||Analysis was performed using logistic regression with fixed effects for treatment, baseline FEV1, weight, age group, and gender.||4.071|0.545|0.7817
91494638|NCT01146418|182861037|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-6.5|3.0|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.0|-6.5|
91733080|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|0.64||||0.008|TWO_SIDED|95.0|0.17|1.11||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.17|0.008
91733081|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.4|4.72||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.72|3.40|<0.001
91733082|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|0.58||||0.017|TWO_SIDED|95.0|0.1|1.06||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.06|0.10|0.017
91494639|NCT01146418|182861038|SUPERIORITY_OR_OTHER_LEGACY||Estimated difference|-1.2|||||TWO_SIDED|95.0|-5.7|3.4|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.4|-5.7|
91733083|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.001|TWO_SIDED|95.0|3.42|4.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.75|3.42|<0.001
91733084|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.359|TWO_SIDED|95.0|-0.26|0.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.70|-0.26|0.359
91733085|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|3.06|4.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.45|3.06|<0.001
91733086|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.436|TWO_SIDED|95.0|-0.7|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.70|0.436
91733087|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|3.4|||<|0.001|TWO_SIDED|95.0|2.66|4.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|2.66|<0.001
91733088|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.139|TWO_SIDED|95.0|-0.93|0.13||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.93|0.139
91733089|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||<|0.001|TWO_SIDED|95.0|2.44|3.95||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.95|2.44|<0.001
91759243|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.789|TWO_SIDED|95.0|-5.2|6.9|||Mixed Models Analysis|||Week 12 Q1||6.9|-5.2|0.789
91494640|NCT03334539|182861039|SUPERIORITY||Least Squares (LS) Mean Difference|0.11||||0.3378|TWO_SIDED|95.0|-0.12|0.34||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.34|-0.12|0.3378
91494641|NCT03334539|182861039|SUPERIORITY||LS Mean Difference|0.12||||0.2883|TWO_SIDED|95.0|-0.1|0.35||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.35|-0.10|0.2883
91494642|NCT03334539|182861039|OTHER||LS Mean Difference|0.01||||0.9293|TWO_SIDED|95.0|-0.22|0.24||P-value calculated using a model with treatment, baseline score, and site as covariates|ANCOVA|||||0.24|-0.22|0.9293
91494643|NCT03334539|182861040|SUPERIORITY||LS Mean Difference|-0.3||||0.1473|TWO_SIDED|95.0|-0.7|0.1||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.1|-0.7|0.1473
91494644|NCT03334539|182861040|SUPERIORITY||LS Mean Difference|-0.3||||0.2321|TWO_SIDED|95.0|-0.7|0.2||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.2|-0.7|0.2321
91494645|NCT03334539|182861040|OTHER||LS Mean Difference|0.0||||0.8217|TWO_SIDED|95.0|-0.4|0.5||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.5|-0.4|0.8217
91494646|NCT04523220|182861116|OTHER||Cox Proportional Hazard|0.59|||=|0.222|TWO_SIDED|90.0|0.28|1.21||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.21|0.28|= 0.222
91494647|NCT04523220|182861116|OTHER||Cox Proportional Hazard|0.72|||=|0.427|TWO_SIDED|90.0|0.36|1.42||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.42|0.36|= 0.427
91494648|NCT04523220|182861117|OTHER||Cox Proportional Hazard|1.27|||=|0.128|TWO_SIDED|90.0|0.98|1.64||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.64|0.98|= 0.128
91529259|NCT03954158|182934816|OTHER||Difference of least squares mean|-1.1|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.4|0.2||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.2|-2.4|
91529260|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
91529261|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.5|
91529262|NCT03954158|182934816|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.6|-0.2||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.2|-2.6|
91733090|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.144|TWO_SIDED|95.0|-0.95|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.95|0.144
91733091|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||<|0.001|TWO_SIDED|95.0|2.01|3.58||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.58|2.01|<0.001
91733092|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|-0.58||||0.043|TWO_SIDED|95.0|-1.15|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.15|0.043
91733093|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|2.33|||<|0.001|TWO_SIDED|95.0|1.53|3.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|1.53|<0.001
91733094|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|-0.59||||0.044|TWO_SIDED|95.0|-1.16|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.16|0.044
91494649|NCT04523220|182861117|OTHER||Cox Proportional Hazard|1.24|||=|0.166|TWO_SIDED|90.0|0.96|1.61||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.61|0.96|= 0.166
91529263|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
91529264|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.2|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.2|
91529265|NCT03954158|182934816|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.2|0.5||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-2.2|
91529266|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.9|
91529267|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.4|-0.7||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.4|
91529268|NCT03954158|182934816|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.9|-0.3||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.3|-2.9|
91529269|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-2.5|0.3||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-2.5|
91529270|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-2.4|-0.6||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.4|
91733095|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.25|2.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.85|1.25|<0.001
91733096|NCT01098747|183361091|SUPERIORITY_OR_OTHER||LS mean difference|-0.65||||0.027|TWO_SIDED|95.0|-1.23|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.08|-1.23|0.027
91494650|NCT00256750|182861121|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.7|||||TWO_SIDED|97.3|-1.1|9.0||||||||9.0|-1.1|
91494651|NCT00256750|182861121|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|2.7|||||TWO_SIDED|97.3|-2.5|8.1|||||If the lower bound of the CI (belatacept-CsA) was \> -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.|||8.1|-2.5|
91529271|NCT03954158|182934816|OTHER||Difference of least squares mean|-1.7|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-3.0|-0.5||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.5|-3.0|
91529272|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.6||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.5|
91529273|NCT03954158|182934816|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.8|-0.4||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.4|-2.8|
91529274|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-2.5|0.1||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-2.5|
91529275|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
91529276|NCT03954158|182934816|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.2|-0.3||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.3|-2.2|
91529277|NCT03954158|182934816|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.8|-0.1||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.1|-2.8|
91529278|NCT04076020|182934838|SUPERIORITY|||||||0.99||||||Results presented from Wilcoxon-Mann-Whitney test with PDC as the dependent variable.|Wilcoxon (Mann-Whitney)|||Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.||||0.99
91529279|NCT04076020|182934838|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.||||<0.05
91529280|NCT04076020|182934839|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.||||<0.05
91529281|NCT03230864|182934846|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.0809|TWO_SIDED|95.0|-0.7|11.65|||Mixed Model Repeated Measures|||The mean changes from randomization in PANNS total score was analysed using a mixed model for repeated measures (MMRM) approach. The model will include the fixed, categorical effects of treatment, strata, visit, treatment-by-visit interaction, fixed covariates of baseline scores and baseline scores-by-visit interaction. An unstructured (co)variance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||11.65|-0.70|0.0809
91529282|NCT05462652|182934857|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.68|-1.59|||Mixed Models Analysis|||||-1.59|-3.68|<0.001
91529283|NCT05462652|182934858|SUPERIORITY||Difference in proportion z-test|20.1|||<|0.001|TWO_SIDED|95.0|9.1|31.0|||Chi-squared|||"Missing values imputed with multiple imputation.~P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test."||31.0|9.1|<0.001
91529284|NCT05462652|182934859|SUPERIORITY||Difference in proportions z-test|15.4||||0.003|TWO_SIDED|95.0|5.3|25.6|||Chi-squared|||P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||25.6|5.3|0.003
91529285|NCT05462652|182934860|SUPERIORITY||Difference in proportion z-test|24.7|||<|0.001|TWO_SIDED|95.0|13.0|36.4|||Chi-squared|||Missing values imputed with multiple imputation. P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||36.4|13.0|<0.001
91494652|NCT00256750|182861122|SUPERIORITY_OR_OTHER||Difference in Percent|-23.7|||<|0.0001|TWO_SIDED|97.3|-33.3|-13.7|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-13.7|-33.3|<.0001
91529286|NCT00479037|182934873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|360.3|||<|0.0001|TWO_SIDED|95.0|256.5|494.3||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||494.3|256.5|<0.0001
91733097|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||<|0.001|TWO_SIDED|95.0|2.27|3.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.18|2.27|<0.001
91733098|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.007|TWO_SIDED|95.0|0.12|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.12|0.007
91733099|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|4.29|||<|0.001|TWO_SIDED|95.0|3.6|4.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.98|3.60|<0.001
91733100|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.144|TWO_SIDED|95.0|-0.13|0.87||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.13|0.144
91733101|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|8.16|||<|0.001|TWO_SIDED|95.0|6.66|9.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.66|6.66|<0.001
91733102|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.679|TWO_SIDED|95.0|-1.31|0.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|-1.31|0.679
91494653|NCT00256750|182861122|SUPERIORITY_OR_OTHER||Difference in Percent|-22.9|||<|0.0001|TWO_SIDED|97.3|-32.6|-12.9|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-12.9|-32.6|<.0001
91702296|NCT00772005|183299636|SUPERIORITY_OR_OTHER|||||||0.5612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5612
91702297|NCT00772005|183299636|SUPERIORITY_OR_OTHER|||||||0.9704||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9704
91702298|NCT00772005|183299636|SUPERIORITY_OR_OTHER|||||||0.2424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2424
91702299|NCT00772005|183299637|SUPERIORITY_OR_OTHER|||||||0.8847||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8847
91702300|NCT00772005|183299637|SUPERIORITY_OR_OTHER|||||||0.2958||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2958
91702301|NCT00772005|183299637|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2660
91702302|NCT00772005|183299638|SUPERIORITY_OR_OTHER|||||||0.0524||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0524
91702303|NCT00772005|183299638|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
91702304|NCT00772005|183299638|SUPERIORITY_OR_OTHER|||||||0.0084||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0084
91733103|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|9.94|||<|0.001|TWO_SIDED|95.0|7.92|11.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.96|7.92|<0.001
91733104|NCT01098747|183361092|SUPERIORITY_OR_OTHER||LS mean difference|-0.67||||0.367|TWO_SIDED|95.0|-2.12|0.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.79|-2.12|0.367
91733105|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||<|0.001|TWO_SIDED|95.0|3.32|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|3.32|< 0.001
91733106|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|0.62||||0.009|TWO_SIDED|95.0|0.16|1.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.07|0.16|0.009
91733107|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|6.15|||<|0.001|TWO_SIDED|95.0|5.18|7.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.12|5.18|<0.001
91733108|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.166|TWO_SIDED|95.0|-0.21|1.2||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.20|-0.21|0.166
91733109|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|11.67|||<|0.001|TWO_SIDED|95.0|9.54|13.81||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.81|9.54|<0.001
91733110|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.703|TWO_SIDED|95.0|-1.84|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|-1.84|0.703
91702305|NCT00772005|183299639|SUPERIORITY_OR_OTHER|||||||0.3651||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3651
91702306|NCT00772005|183299639|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
91702307|NCT00772005|183299639|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
91702308|NCT00772005|183299640|SUPERIORITY_OR_OTHER|||||||0.2091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2091
91702309|NCT00772005|183299640|SUPERIORITY_OR_OTHER|||||||0.0706||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0706
91702310|NCT00772005|183299640|SUPERIORITY_OR_OTHER|||||||0.3052||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3052
91702311|NCT00772005|183299641|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9960
91702312|NCT00772005|183299641|SUPERIORITY_OR_OTHER|||||||0.3604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3604
91702313|NCT00772005|183299641|SUPERIORITY_OR_OTHER|||||||0.9528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9528
91702314|NCT00772005|183299642|SUPERIORITY_OR_OTHER|||||||0.9797||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9797
91702315|NCT00772005|183299642|SUPERIORITY_OR_OTHER|||||||0.6173||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6173
91529287|NCT00479037|182934874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.9|||<|0.0001|TWO_SIDED|95.0|63.8|127.1||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||127.1|63.8|<0.0001
91733111|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|14.27|||<|0.001|TWO_SIDED|95.0|11.36|17.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||17.18|11.36|<0.001
91733112|NCT01098747|183361093|SUPERIORITY_OR_OTHER||LS mean difference|-1.1||||0.303|TWO_SIDED|95.0|-3.2|1.0||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.00|-3.20|0.303
91759244|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.643|TWO_SIDED|95.0|-9.0|5.6||Week 12Q1|Mixed Models Analysis|||||5.6|-9.0|0.643
91759245|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.052|TWO_SIDED|95.0|-14.7|0.1||Week 24 Q1|Mixed Models Analysis|||||0.1|-14.7|0.052
91702316|NCT00772005|183299642|SUPERIORITY_OR_OTHER|||||||0.5415||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5415
91702317|NCT00772005|183299643|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
91702318|NCT00772005|183299643|SUPERIORITY_OR_OTHER|||||||0.6642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6642
91702319|NCT00772005|183299643|SUPERIORITY_OR_OTHER|||||||0.7395||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7395
91702320|NCT00772005|183299644|SUPERIORITY_OR_OTHER|||||||0.8124||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8124
91702321|NCT00772005|183299644|SUPERIORITY_OR_OTHER|||||||0.8961||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8961
91702322|NCT00772005|183299644|SUPERIORITY_OR_OTHER|||||||0.4999||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4999
91702323|NCT00772005|183299654|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4540
91702324|NCT00772005|183299654|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3580
91702325|NCT00772005|183299654|SUPERIORITY_OR_OTHER|||||||0.6271||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6271
91702326|NCT00772005|183299655|SUPERIORITY_OR_OTHER|||||||0.1459||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1459
91702327|NCT00772005|183299655|SUPERIORITY_OR_OTHER|||||||0.6004||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6004
91702328|NCT00772005|183299655|SUPERIORITY_OR_OTHER|||||||0.0192||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0192
91702329|NCT00772005|183299656|SUPERIORITY_OR_OTHER|||||||0.8455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8455
91702330|NCT00772005|183299656|SUPERIORITY_OR_OTHER|||||||0.8715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8715
91702331|NCT00772005|183299656|SUPERIORITY_OR_OTHER|||||||0.0309||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0309
91494654|NCT00256750|182861123|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|10.0|||||TWO_SIDED|97.3|3.3|17.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||17.1|3.3|
91494655|NCT00256750|182861123|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.5|22.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||22.2|7.5|
91494656|NCT00256750|182861124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|||<|0.0001|TWO_SIDED|97.3|7.3|18.7||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||18.7|7.3|<0.0001
91494657|NCT00256750|182861124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|97.3|8.9|20.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||20.4|8.9|<0.0001
91494658|NCT00256750|182861124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.0001|TWO_SIDED|97.3|11.5|23.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||23.4|11.5|<0.0001
91494659|NCT00256750|182861124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.5|||<|0.0001|TWO_SIDED|97.3|8.5|20.5||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||20.5|8.5|<0.0001
91494660|NCT00256750|182861125|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-8.5||||0.0581|TWO_SIDED|97.3|-17.9|0.9|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||0.9|-17.9|0.0581
91494661|NCT00256750|182861125|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-14.2||||0.001|TWO_SIDED|97.3|-23.2|-5.0|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||-5.0|-23.2|0.0010
91494662|NCT00256750|182861130|SUPERIORITY_OR_OTHER||Difference in Percent|-8.5|||||TWO_SIDED|97.3|-14.6|-3.3|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-3.3|-14.6|
91494663|NCT00256750|182861130|SUPERIORITY_OR_OTHER||Difference in Percent|-10.3|||||TWO_SIDED|97.3|-16.1|-5.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-5.1|-16.1|
91529288|NCT00479037|182934875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.5|||<|0.0001|TWO_SIDED|95.0|94.8|191.8||P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||191.8|94.8|<0.0001
91494664|NCT00256750|182861134|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.3|||||TWO_SIDED|97.3|10.3|20.3|||||ANOVA model: GFR = treatment|Month 12||20.3|10.3|
91494665|NCT00256750|182861134|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.1|||||TWO_SIDED|97.3|10.1|20.1|||||ANOVA model: GFR = treatment|Month 12||20.1|10.1|
91494666|NCT00256750|182861134|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.5|||||TWO_SIDED|97.3|12.0|23.1|||||ANOVA model: GFR = treatment|Month 24||23.1|12.0|
91494667|NCT00256750|182861134|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.6|||||TWO_SIDED|97.3|12.0|23.3|||||ANOVA model: GFR = treatment|Month 24||23.3|12.0|
91494668|NCT00256750|182861134|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|21.4|||||TWO_SIDED|97.3|15.4|27.4|||||ANOVA model: GFR = treatment|Month 36||27.4|15.4|
91494669|NCT00256750|182861134|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|20.8|||||TWO_SIDED|97.3|14.8|26.9|||||ANOVA model: GFR = treatment|Month 36||26.9|14.8|
91494670|NCT00256750|182861136|SUPERIORITY_OR_OTHER||Difference in Percent|-5.7||||0.0687|TWO_SIDED|97.3|-12.6|0.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||0.5|-12.6|0.0687
91733113|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|6.68|||<|0.001|TWO_SIDED|95.0|5.6|7.76||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||7.76|5.60|<0.001
91733114|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.007|TWO_SIDED|95.0|0.29|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.84|0.29|0.007
91733115|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|8.79|12.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||12.08|8.79|<0.001
91733116|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|0.87||||0.152|TWO_SIDED|95.0|-0.32|2.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.05|-0.32|0.152
91733117|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|19.83|||<|0.001|TWO_SIDED|95.0|16.23|23.43||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||23.43|16.23|<0.001
91733118|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.69|TWO_SIDED|95.0|-3.12|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.07|-3.12|0.690
91733119|NCT01098747|183361094|SUPERIORITY_OR_OTHER||LS mean difference|-1.77||||0.323|TWO_SIDED|95.0|-5.29|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-8 Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.75|-5.29|0.323
91733120|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|1.01||||0.49|TWO_SIDED|95.0|-0.97|3.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.00|-0.97|0.490
91733121|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|0.54||||0.623|TWO_SIDED|95.0|-1.88|2.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.95|-1.88|0.623
91733122|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|24.36|||<|0.001|TWO_SIDED|95.0|13.51|35.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||35.22|13.51|<0.001
91702332|NCT00772005|183299657|SUPERIORITY_OR_OTHER|||||||0.2664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2664
91733123|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|11.82||||0.023|TWO_SIDED|95.0|1.15|22.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.48|1.15|0.023
91759246|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.481|TWO_SIDED|95.0|-14.0|6.6||Week 24 Q1|Mixed Models Analysis|||||6.6|-14.0|0.481
91702333|NCT00772005|183299657|SUPERIORITY_OR_OTHER|||||||0.3528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3528
91702334|NCT00772005|183299657|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0380
91702335|NCT00772005|183299658|SUPERIORITY_OR_OTHER|||||||0.3316||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3316
91702336|NCT00772005|183299658|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3490
91702337|NCT00772005|183299658|SUPERIORITY_OR_OTHER|||||||0.0926||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0926
91494671|NCT00256750|182861136|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8||||0.4825|TWO_SIDED|97.3|-10.2|4.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||4.4|-10.2|0.4825
91494672|NCT00256750|182861136|SUPERIORITY_OR_OTHER||Difference in Percent|-5.1||||0.1267|TWO_SIDED|97.3|-12.3|1.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||1.5|-12.3|0.1267
91494673|NCT00256750|182861136|SUPERIORITY_OR_OTHER||Difference in Percent|-2.2||||0.6405|TWO_SIDED|97.3|-9.8|5.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||5.4|-9.8|0.6405
91494674|NCT00256750|182861136|SUPERIORITY_OR_OTHER||Difference in Percent|-4.6||||0.2043|TWO_SIDED|97.3|-12.0|2.5|||Chi-squared|Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.||Month 36||2.5|-12.0|0.2043
91494675|NCT00256750|182861136|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9||||0.9481|TWO_SIDED|97.3|-8.8|7.1||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 36||7.1|-8.8|0.9481
91494676|NCT00256750|182861137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0002|TWO_SIDED|97.3|0.31|0.74|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.74|0.31|0.0002
91494677|NCT00256750|182861137|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.6||||0.0092|TWO_SIDED|97.3|0.38|0.92|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.92|0.38|0.0092
91529289|NCT02368002|182934903|SUPERIORITY|||||||0.25||||||2 df re-random\*time interaction tested if baseline to 6M or 18M PCM and ABT weight changes differed; primary hypothesis tests were 2 planned contrasts estimating baseline to 6M (H1a, expected neg) and 18M (H1b, expected pos) PCM vs. ABT weight change|Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.||H1 predicted that suboptimal responders re-randomized to PCM would lose more weight at 6m (H1a) while those re-randomized to ABT would lose more weight at 18m (H1b). A mixed linear model predicted weight change from fixed re-randomization, measurement time, the re-randomization by measurement time interaction and covariate parameters.|The primary hypothesis tests were two planned contrasts that estimated weight change from baseline to 6M and 18M relative to baseline in PCM relative to ABT. A mixed linear model predicted weight changes between baseline and post-baseline for suboptimal responders, and this model included two a priori simple effects tests resulting in two mean differences, confidence intervals, and p-values. H1a: -2.7 lbs; 95% CI: -5.8, 0.5; p=0.09. H1b: -1.0 lbs; 95% CI: -4.2, 2.2; p=0.53|||0.25
91733124|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|61.35|||<|0.001|TWO_SIDED|95.0|48.99|73.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.70|48.99|<0.001
91733125|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|21.25|||<|0.001|TWO_SIDED|95.0|9.58|32.92||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.92|9.58|<0.001
91494678|NCT00256750|182861138|SUPERIORITY_OR_OTHER||Difference in Percent|-21.2|||||TWO_SIDED|97.3|-67.6|43.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||43.2|-67.6|
91759247|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.195|TWO_SIDED|95.0|-15.6|3.2||Week 36 Q1|Mixed Models Analysis|||||3.2|-15.6|0.195
91494679|NCT00256750|182861138|SUPERIORITY_OR_OTHER||Difference in Percent|-17.9|||||TWO_SIDED|97.3|-72.3|52.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||52.2|-72.3|
91494680|NCT00256750|182861139|SUPERIORITY_OR_OTHER||Difference in Percent|-1.13|||||TWO_SIDED|97.3|-7.51|5.23|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||5.23|-7.51|
91494681|NCT00256750|182861139|SUPERIORITY_OR_OTHER||Difference in Percent|-2.37|||||TWO_SIDED|97.3|-9.01|4.15|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||4.15|-9.01|
91494682|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.3|||||TWO_SIDED|97.3|-11.4|-3.3||||||Systolic, Month 12||-3.3|-11.4|
91494683|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-6.0|||||TWO_SIDED|97.3|-10.1|-2.0||||||Systolic, Month 12||-2.0|-10.1|
91494684|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.2|||||TWO_SIDED|97.3|-5.8|-0.7||||||Diastolic, Month 12||-0.7|-5.8|
91494685|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.6|||||TWO_SIDED|97.3|-5.1|0.0||||||Diastolic, Month 12||0.0|-5.1|
91494686|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-4.9|||||TWO_SIDED|97.3|-9.2|-0.6||||||Systolic, Month 24||-0.6|-9.2|
91494687|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.5|||||TWO_SIDED|97.3|-9.9|-1.1||||||Systolic, Month 24||-1.1|-9.9|
91494688|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-1.9|||||TWO_SIDED|97.3|-4.4|0.5||||||Diastolic, Month 24||0.5|-4.4|
91494689|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.4|||||TWO_SIDED|97.3|-5.0|0.1||||||Diastolic, Month 24||0.1|-5.0|
91494690|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.8|||||TWO_SIDED|97.3|-10.0|-1.6||||||Systolic, Month 36||-1.6|-10.0|
91494691|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.5|||||TWO_SIDED|97.3|-11.7|-3.3||||||Systolic, Month 36||-3.3|-11.7|
91494692|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.9|||||TWO_SIDED|97.3|-5.4|-0.4||||||Diastolic, Month 36||-0.4|-5.4|
91494693|NCT00256750|182861140|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.4|||||TWO_SIDED|97.3|-6.0|-0.9||||||Diastolic, Month 36||-0.9|-6.0|
91494694|NCT00256750|182861141|SUPERIORITY_OR_OTHER||Difference in Percent|7.1|||||TWO_SIDED|97.3|-2.9|17.1|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||17.1|-2.9|
91733126|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|72.65|||<|0.001|TWO_SIDED|95.0|61.59|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|61.59|<0.001
91733127|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|17.44||||0.001|TWO_SIDED|95.0|7.83|27.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.06|7.83|0.001
91733128|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|72.63|||<|0.001|TWO_SIDED|95.0|61.14|84.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.11|61.14|<0.001
91733129|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|11.7||||0.013|TWO_SIDED|95.0|3.47|19.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.93|3.47|0.013
91733130|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
91733131|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|8.01||||0.041|TWO_SIDED|95.0|1.27|14.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.75|1.27|0.041
91494695|NCT00256750|182861141|SUPERIORITY_OR_OTHER||Difference in Percent|3.2|||||TWO_SIDED|97.3|-6.6|12.9|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||12.9|-6.6|
91494696|NCT00256750|182861142|SUPERIORITY_OR_OTHER||Difference in Percent|7.01|||||TWO_SIDED|97.3|-2.79|16.71|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||16.71|-2.79|
91494697|NCT00256750|182861142|SUPERIORITY_OR_OTHER||Difference in Percent|3.77|||||TWO_SIDED|97.3|-5.86|13.35|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||13.35|-5.86|
91494698|NCT00256750|182861147|SUPERIORITY_OR_OTHER||Difference in Percent|-10.4|||||TWO_SIDED|97.3|-21.4|1.0||||||||1.0|-21.4|
91529290|NCT02368002|182934904|SUPERIORITY||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.4|2.3|||Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).||Hypothesis 2 predicted that among all participants, those randomized to Early TRA would lose more weight at 6 and 18 months than those randomized to Late TRA. A mixed linear model predicted weight change from fixed treatment response assessment timing and covariate parameters.||2.3|-2.4|0.96
91529291|NCT02001974|182934916|OTHER|||||||0.0341|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0341
91494699|NCT00256750|182861147|SUPERIORITY_OR_OTHER||Difference in Percent|-8.7|||||TWO_SIDED|97.3|-19.9|2.7||||||||2.7|-19.9|
91494700|NCT00256750|182861149|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|11.4|||||TWO_SIDED|97.3|5.0|18.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||18.2|5.0|
91529292|NCT02001974|182934916|OTHER|||||||0.0636|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0636
91529293|NCT02001974|182934916|OTHER|||||||0.0487|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.0487
91529294|NCT02001974|182934916|OTHER|||||||0.3498|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.3498
91529295|NCT02001974|182934916|OTHER|||||||0.0096|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.0096
91733132|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
91733133|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
91733134|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
91759248|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.857|TWO_SIDED|95.0|-12.9|10.7||Week 36 Q1|Mixed Models Analysis|||||10.7|-12.9|0.857
91733135|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
91733136|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
91494701|NCT00256750|182861149|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|16.5|||||TWO_SIDED|97.3|9.6|23.8|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||23.8|9.6|
91494702|NCT00256750|182861149|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|8.2|||||TWO_SIDED|97.3|1.2|15.4|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used|Month 24||15.4|1.2|
91529296|NCT02001974|182934916|OTHER|||||||0.1374|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.1374
91733137|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
91733138|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|74.71|||<|0.001|TWO_SIDED|95.0|63.14|86.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.27|63.14|<0.001
91733139|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|7.84||||0.035|TWO_SIDED|95.0|1.57|14.1||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.10|1.57|0.035
91733140|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733141|NCT01098747|183361095|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91733142|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|20.01||||0.004|TWO_SIDED|95.0|8.79|31.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.24|8.79|0.004
91733143|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|14.35||||0.003|TWO_SIDED|95.0|4.26|24.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.43|4.26|0.003
91733144|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|69.53|||<|0.001|TWO_SIDED|95.0|57.67|81.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.40|57.67|<0.001
91759249|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.422|TWO_SIDED|95.0|-15.9|6.7||Week 48 Q1|Mixed Models Analysis|||||6.7|-15.9|0.422
91759250|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.562|TWO_SIDED|95.0|-15.7|8.6||Week 48 Q1|Mixed Models Analysis|||||8.6|-15.7|0.562
91759251|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.129|TWO_SIDED|95.0|-2.6|20.2||Week 12 Q2|Mixed Models Analysis|||||20.2|-2.6|0.129
91759252|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.194|TWO_SIDED|95.0|-4.0|19.9||Week 12 Q2|Mixed Models Analysis|||||19.9|-4.0|0.194
91529297|NCT02001974|182934916|OTHER|||||||0.0065|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.0065
91529298|NCT02001974|182934916|OTHER|||||||0.147|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.1470
91529299|NCT02001974|182934917|OTHER|||||||0.0015|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0015
91529300|NCT02001974|182934917|OTHER|||||||0.0176|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0176
91494703|NCT00256750|182861149|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|15.2|||||TWO_SIDED|97.3|7.5|23.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 24||23.0|7.5|
91494704|NCT00256750|182861149|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|7.8|||||TWO_SIDED|97.3|0.6|15.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||15.0|0.6|
91494705|NCT00256750|182861149|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.0|22.6|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||22.6|7.0|
91494706|NCT00256750|182861151|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
91494707|NCT00256750|182861151|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
91494708|NCT00256750|182861155|SUPERIORITY_OR_OTHER||Difference in Percent|-0.5|||||TWO_SIDED|97.3|-6.5|5.3||||||Month 12||5.3|-6.5|
91494709|NCT00256750|182861155|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9|||||TWO_SIDED|97.3|-6.9|4.8||||||||4.8|-6.9|
91494710|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6573|TWO_SIDED|95.0|-1.6|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.6|-1.6|0.6573
91494711|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1198|TWO_SIDED|95.0|-0.4|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.4|0.1198
91529301|NCT02001974|182934917|OTHER|||||||0.0048|||||||ANOVA|||DF2243 Cmax at Day 1||||0.0048
91529302|NCT02001974|182934917|OTHER|||||||0.2083|||||||ANOVA|||DF2243 Cmax at Day 1||||0.2083
91529303|NCT02001974|182934917|OTHER|||||||0.0111|||||||ANOVA|||DF2243 Cmax at Day 8||||0.0111
91494712|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.0672|TWO_SIDED|95.0|-0.1|3.2||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.2|-0.1|0.0672
91494713|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0257|TWO_SIDED|95.0|0.2|3.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.6|0.2|0.0257
91494714|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4146|TWO_SIDED|95.0|-1.2|2.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.9|-1.2|0.4146
91494715|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7327|TWO_SIDED|95.0|-1.7|2.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.4|-1.7|0.7327
91529304|NCT02001974|182934917|OTHER|||||||0.1441|||||||ANOVA|||DF2243 Cmax at Day 8||||0.1441
91529305|NCT02001974|182934917|OTHER|||||||0.0283|||||||ANOVA|||DF2243 Cmax at Day 21||||0.0283
91529306|NCT02001974|182934917|OTHER|||||||0.1331|||||||ANOVA|||DF2243 Cmax at Day 21||||0.1331
91529307|NCT02001974|182934918|OTHER|||||||0.0097|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0097
91529308|NCT02001974|182934918|OTHER|||||||0.0354|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0354
91529309|NCT02001974|182934918|OTHER|||||||0.02|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.0200
91529310|NCT02001974|182934918|OTHER|||||||0.2134|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.2134
91529311|NCT02001974|182934918|OTHER|||||||0.0235|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0235
91529312|NCT02001974|182934918|OTHER|||||||0.0964|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0964
91494716|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0144|TWO_SIDED|95.0|0.4|3.8||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.8|0.4|0.0144
91529313|NCT02001974|182934918|OTHER|||||||0.0314|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0314
91733145|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|23.45|||<|0.001|TWO_SIDED|95.0|13.16|33.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.75|13.16|<0.001
91529314|NCT02001974|182934918|OTHER|||||||0.0773|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0773
91733146|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|73.72|||<|0.001|TWO_SIDED|95.0|62.77|84.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.67|62.77|<0.001
91733147|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|10.14||||0.014|TWO_SIDED|95.0|3.21|17.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.08|3.21|0.014
91733148|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733149|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|8.35||||0.028|TWO_SIDED|95.0|2.02|14.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.68|2.02|0.028
91733150|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733151|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.81||||0.036|TWO_SIDED|95.0|1.54|14.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.08|1.54|0.036
91529315|NCT02001974|182934919|OTHER|||||||0.1016|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.1016
91529316|NCT02001974|182934919|OTHER|||||||0.2001|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.2001
91529317|NCT02001974|182934919|OTHER|||||||0.0802|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.0802
91733152|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733153|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91733154|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91759253|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.832|TWO_SIDED|95.0|-10.5|13.1||Week 24 Q2|Mixed Models Analysis|||||13.1|-10.5|0.832
91759254|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.351|TWO_SIDED|95.0|-6.8|19.1||Week 24 Q2|Mixed Models Analysis|||||19.1|-6.8|0.351
91529318|NCT02001974|182934919|OTHER|||||||0.4728|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.4728
91529319|NCT02001974|182934919|OTHER|||||||0.0355|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0355
91529320|NCT02001974|182934919|OTHER|||||||0.1709|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1709
91529321|NCT02001974|182934919|OTHER|||||||0.0685|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.0685
91529322|NCT02001974|182934919|OTHER|||||||0.3189|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.3189
91529323|NCT02001974|182934920|OTHER|||||||0.2375|||||||ANOVA|||Paclitaxel, Cmax, Day 1||||0.2375
91529324|NCT02001974|182934920|OTHER|||||||0.3608|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.3608
91529325|NCT02001974|182934920|OTHER|||||||0.0442|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0442
91529326|NCT02001974|182934920|OTHER|||||||0.1067|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1067
91529327|NCT02001974|182934926|OTHER|||||||0.0134|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0134
91529328|NCT02001974|182934926|OTHER|||||||0.0799|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0799
91529329|NCT02001974|182934926|OTHER|||||||0.0241|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.0241
91529330|NCT02001974|182934926|OTHER|||||||0.01384|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.01384
91529331|NCT02001974|182934926|OTHER|||||||0.0091|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.0091
91529332|NCT02001974|182934926|OTHER|||||||0.5687|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.5687
91529333|NCT02001974|182934926|OTHER|||||||0.0058|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.0058
91529334|NCT02001974|182934926|OTHER|||||||0.3667|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.3667
91529335|NCT02001974|182934927|OTHER|||||||0.0029|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0029
91529336|NCT02001974|182934927|OTHER|||||||0.0349|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0349
91529337|NCT02001974|182934927|OTHER|||||||0.0119|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.0119
91529338|NCT02001974|182934927|OTHER|||||||0.21|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.2100
91529339|NCT02001974|182934927|OTHER|||||||0.0165|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.0165
91529340|NCT02001974|182934927|OTHER|||||||0.1496|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.1496
91529341|NCT02001974|182934927|OTHER|||||||0.0321|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.0321
91529342|NCT02001974|182934927|OTHER|||||||0.1404|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.1404
91529343|NCT02001974|182934928|OTHER|||||||0.0081|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0081
91529344|NCT02001974|182934928|OTHER|||||||0.064|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0640
91529345|NCT02001974|182934928|OTHER|||||||0.0397|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.0397
91529346|NCT02001974|182934928|OTHER|||||||0.1898|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.1898
91529347|NCT02001974|182934928|OTHER|||||||0.025|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.0250
91529348|NCT02001974|182934928|OTHER|||||||0.1605|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.1605
91529349|NCT02001974|182934928|OTHER|||||||0.0786|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.0786
91529350|NCT02001974|182934928|OTHER|||||||0.2652|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.2652
91529351|NCT02001974|182934929|OTHER|||||||0.1335|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.1335
91529352|NCT02001974|182934929|OTHER|||||||0.2658|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.2658
91529353|NCT02001974|182934929|OTHER|||||||0.1063|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1063
91529354|NCT02001974|182934929|OTHER|||||||0.4959|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.4959
91529355|NCT02001974|182934929|OTHER|||||||0.0452|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0452
91529356|NCT02001974|182934929|OTHER|||||||0.2223|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.2223
91529357|NCT02001974|182934929|OTHER|||||||0.0737|||||||ANOVA|||Ibuprofen, AUC0-8, Day 21||||0.0737
91529358|NCT02001974|182934929|OTHER|||||||0.2804|||||||ANOVA|||Ibuprofen, AUC0-8, Day21||||0.2804
91529359|NCT02001974|182934930|OTHER|||||||0.1449|||||||ANOVA|||Paclitaxel, AUC0-8, Day 1||||0.1449
91529360|NCT02001974|182934930|OTHER|||||||0.1338|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1338
91529361|NCT02001974|182934930|OTHER|||||||0.0633|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0633
91529362|NCT02001974|182934930|OTHER|||||||0.6939|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.6939
91529363|NCT01380990|182934948|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
91529364|NCT01380990|182934948|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
91529365|NCT01380990|182934948|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
91529366|NCT01380990|182934948|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
91702338|NCT00772005|183299659|SUPERIORITY_OR_OTHER|||||||0.8835||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8835
91494717|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||4.5|1.1|0.0015
91529367|NCT01380990|182934948|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
91494718|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.234|TWO_SIDED|95.0|-0.8|3.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.8|0.2340
91494719|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6635|TWO_SIDED|95.0|-1.7|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.6|-1.7|0.6635
91494720|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0417|TWO_SIDED|95.0|0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.5|0.1|0.0417
91494721|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0026|TWO_SIDED|95.0|0.9|4.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||4.4|0.9|0.0026
91494722|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0953|TWO_SIDED|95.0|-0.3|4.1||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.1|-0.3|0.0953
91494723|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1961|TWO_SIDED|95.0|-0.8|3.7||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||3.7|-0.8|0.1961
91494724|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0191|TWO_SIDED|95.0|0.3|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.9|0.3|0.0191
91494725|NCT00256750|182861157|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0684|TWO_SIDED|95.0|-0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.5|-0.1|0.0684
91494726|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0714|TWO_SIDED|95.0|-0.2|3.9|||ANOVA|Domain Score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||3.9|-0.2|0.0714
91494727|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0536|TWO_SIDED|95.0|0.0|4.1|||ANOVA|Domain score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||4.1|-0.0|0.0536
91494728|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7543|TWO_SIDED|95.0|-1.6|2.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||2.2|-1.6|0.7543
91494729|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.2499|TWO_SIDED|95.0|-0.8|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||3.0|-0.8|0.2499
91494730|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.2||||0.8332|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||2.3|-1.9|0.8332
91529368|NCT01380990|182934948|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
91529369|NCT01380990|182934949|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
91494731|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2523|TWO_SIDED|95.0|-0.9|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||3.4|-0.9|0.2523
91529370|NCT01380990|182934949|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
91759255|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.949|TWO_SIDED|95.0|-13.3|12.5||Week 36 Q2|Mixed Models Analysis|||||12.5|-13.3|0.949
91759256|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.253|TWO_SIDED|95.0|-6.0|22.6||Week 36 Q2|Mixed Models Analysis|||||22.6|-6.0|0.253
91759257|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.735|TWO_SIDED|95.0|-16.2|11.4||Week 48 Q2|Mixed Models Analysis|||||11.4|-16.2|0.735
91494732|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3018|TWO_SIDED|95.0|-0.8|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.7|-0.8|0.3018
91494733|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.6||||0.5437|TWO_SIDED|95.0|-1.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.3|-1.2|0.5437
91494734|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.237|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||3.6|-0.9|0.2370
91494735|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0588|TWO_SIDED|95.0|-0.1|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||4.5|-0.1|0.0588
91494736|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0502|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Physical, Month 6||4.0|-0.0|0.0502
91494737|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.6||||0.0007|TWO_SIDED|95.0|1.5|5.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 6||5.6|1.5|0.0007
91494738|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7637|TWO_SIDED|95.0|-1.8|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.4|-1.8|0.7637
91494739|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7006|TWO_SIDED|95.0|-1.7|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.5|-1.7|0.7006
91494740|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1222|TWO_SIDED|95.0|-0.4|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||3.4|-0.4|0.1222
91494741|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0289|TWO_SIDED|95.0|0.2|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||4.1|0.2|0.0289
91494742|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0571|TWO_SIDED|95.0|-0.1|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||3.8|-0.1|0.0571
91494743|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.9||||0.0042|TWO_SIDED|95.0|0.9|4.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||4.9|0.9|0.0042
91494744|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0423|TWO_SIDED|95.0|0.1|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||3.7|0.1|0.0423
91494745|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0174|TWO_SIDED|95.0|0.4|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||4.1|0.4|0.0174
91759258|NCT00348309|183411454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2||||0.046|TWO_SIDED|95.0|0.3|32.0||Week 48 Q2|Mixed Models Analysis|||||32.0|0.3|0.046
91759259|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.914|TWO_SIDED|95.0|-2.3|2.0||Week 12 Thermometer|Mixed Models Analysis|||||2.0|-2.3|0.914
91759260|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.415|TWO_SIDED|95.0|-3.3|1.4||Week 12 Thermometer|Mixed Models Analysis|||||1.4|-3.3|0.415
91759261|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.063|TWO_SIDED|95.0|-4.9|0.1||Week 36 Thermometer|Mixed Models Analysis|||||0.1|-4.9|0.063
91759262|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.03|TWO_SIDED|95.0|-5.6|-0.3||Week 36 Thermometer|Mixed Models Analysis|||||-0.3|-5.6|0.030
91759263|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.392|TWO_SIDED|95.0|-1.5|3.8||Week 48 Thermometer|Mixed Models Analysis|||||3.8|-1.5|0.392
91759264|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.557|TWO_SIDED|95.0|-3.7|2.0||Week 48 Thermometer|Mixed Models Analysis|||||2.0|-3.7|0.557
91759265|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.03||Week 12 Utility|Mixed Models Analysis|||||0.03|-0.01|0.320
91759266|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.18|TWO_SIDED|95.0|-0.04|0.01||Week 12 Utility|Mixed Models Analysis|||||0.01|-0.04|0.180
91759267|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.498|TWO_SIDED|95.0|-0.02|0.04||Week 36 Utility|Mixed Models Analysis|||||0.04|-0.02|0.498
91759268|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.081|TWO_SIDED|95.0|-0.06|0.0||Week 36 Utility|Mixed Models Analysis|||||0.00|-0.06|0.081
91759269|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.077|TWO_SIDED|95.0|0.0|0.06||Week 48 Utility|Mixed Models Analysis|||||0.06|-0.00|0.077
91759270|NCT00348309|183411455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.64|TWO_SIDED|95.0|-0.04|0.03||Week 48 Utility|Mixed Models Analysis|||||0.03|-0.04|0.640
91759271|NCT00348309|183411456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.105|TWO_SIDED|95.0|-1.6|0.2|||ANCOVA|||||0.2|-1.6|0.105
91759272|NCT00348309|183411456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.483|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.483
91494746|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.363|TWO_SIDED|95.0|-1.1|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 12||3.0|-1.1|0.3630
91529371|NCT01380990|182934949|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
91529372|NCT01380990|182934949|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
91529373|NCT01380990|182934949|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
91529374|NCT01380990|182934949|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
91529375|NCT01380990|182934954|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||=|0.002|||||||Mixed Models Analysis|||"Mixed-Effect Model Repeated Measure (MMRM) Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study subjects group."||||= 0.002
91529376|NCT01380990|182934954|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||<|0.001|||||||Mixed Models Analysis|||"MMRM Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study and CUP subjects group."||||< 0.001
91529377|NCT01380990|182934959|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
91529378|NCT01380990|182934959|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-22.41|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||48.25|-22.41|
91529379|NCT01380990|182934959|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-28.1|34.23||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||34.23|-28.10|
91494747|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6319|TWO_SIDED|95.0|-1.6|2.6|||ANOVA|Missing data were imputed by LOCF|Missing data were imputed by LOCF|Mental Health, Month 12||2.6|-1.6|0.6319
91494748|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0503|TWO_SIDED|95.0|0.0|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||3.7|-0.0|0.0503
91494749|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3291|TWO_SIDED|95.0|-0.9|2.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||2.8|-0.9|0.3291
91529380|NCT01380990|182934959|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
91529381|NCT01380990|182934959|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-10.01|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||48.25|-10.01|
91529382|NCT01380990|182934959|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-12.91|33.87||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||33.87|-12.91|
91529383|NCT01380990|182934960|SUPERIORITY||||||=|0.645|||||||Log Rank|||||||=0.645
91529384|NCT01380990|182934960|SUPERIORITY||||||=|0.299|||||||Log Rank|||||||=0.299
91529385|NCT01380990|182934960|SUPERIORITY||||||=|0.2|||||||Log Rank|||||||= 0.2
91529386|NCT01380990|182934960|SUPERIORITY||||||=|0.028|||||||Log Rank|||||||= 0.028
91529387|NCT01380990|182934960|SUPERIORITY||||||=|0.259|||||||Log Rank|||||||= 0.259
91529388|NCT01380990|182934960|SUPERIORITY||||||=|0.044|||||||Log Rank|||||||= 0.044
91529389|NCT01380990|182934960|SUPERIORITY||Difference in percentages|10.0|||||TWO_SIDED|95.0|-32.05|61.97||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||61.97|-32.05|
91529390|NCT01380990|182934960|SUPERIORITY||Difference in percentages|30.0|||||TWO_SIDED|95.0|-10.72|65.87||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||65.87|-10.72|
91733155|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91759273|NCT00348309|183411457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||||-0.2|-0.9|0.004
91494750|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.386|TWO_SIDED|95.0|-1.2|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||3.1|-1.2|0.3860
91494751|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.0||||0.9672|TWO_SIDED|95.0|-2.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||2.3|-2.2|0.9672
91494752|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0392|TWO_SIDED|95.0|0.1|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.1|0.1|0.0392
91494753|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0151|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.5|0.5|0.0151
91494754|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.3978|TWO_SIDED|95.0|-1.1|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||2.7|-1.1|0.3978
91494755|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1263|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||3.5|-0.4|0.1263
91494756|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.016|TWO_SIDED|95.0|0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.2|0.4|0.0160
91494757|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0075|TWO_SIDED|95.0|0.7|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.5|0.7|0.0075
91494758|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.699|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||2.4|-1.6|0.6990
91494759|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1608|TWO_SIDED|95.0|-0.6|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||3.5|-0.6|0.1608
91494760|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0214|TWO_SIDED|95.0|0.3|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.0|0.3|0.0214
91494761|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.00886|TWO_SIDED|95.0|0.6|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.4|0.6|0.00886
91494762|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.2555|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||3.3|-0.9|0.2555
91494763|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4804|TWO_SIDED|95.0|-1.4|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||2.9|-1.4|0.4804
91494764|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0276|TWO_SIDED|95.0|0.2|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||4.2|0.2|0.0276
91494765|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1285|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||3.5|-0.4|0.1285
91494766|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1352|TWO_SIDED|95.0|-0.5|3.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.9|-0.5|0.1352
91494767|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2663|TWO_SIDED|95.0|-1.0|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.5|-1.0|0.2663
91494768|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0164|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||4.5|0.5|0.0164
91494769|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.9||||0.0002|TWO_SIDED|95.0|1.9|5.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||5.9|1.9|0.0002
91494770|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1914|TWO_SIDED|95.0|-0.7|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||3.3|-0.7|0.1914
91494771|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.6882|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||2.4|-1.6|0.6882
91494772|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0547|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||4.0|-0.0|0.0547
91494773|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0992|TWO_SIDED|95.0|-0.3|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||3.8|-0.3|0.0992
91494774|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0339|TWO_SIDED|95.0|0.2|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||4.4|0.2|0.0339
91494775|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3572|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||3.1|-1.1|0.3572
91494776|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0211|TWO_SIDED|95.0|0.3|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.2|0.3|0.0211
91494777|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.045|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.0|0.0|0.0450
91494778|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.171|TWO_SIDED|95.0|-0.7|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.7|-0.7|0.1710
91494779|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2484|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.6|-0.9|0.2484
91494780|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1836|TWO_SIDED|95.0|-0.6|3.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||3.2|-0.6|0.1836
91494781|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3303|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||2.9|-1.0|0.3303
91494782|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0299|TWO_SIDED|95.0|0.2|4.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.8|0.2|0.0299
91494783|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.1141|TWO_SIDED|95.0|-0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.2|-0.4|0.1141
91529391|NCT01380990|182934960|SUPERIORITY||Difference in percentages|23.33|||||TWO_SIDED|95.0|-15.24|54.59||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||54.59|-15.24|
91529392|NCT01380990|182934960|SUPERIORITY||Difference in percentages|15.0|||||TWO_SIDED|95.0|-13.7|63.54||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||63.54|-13.70|
91529393|NCT01380990|182934960|SUPERIORITY||Difference in percentages|35.0|||||TWO_SIDED|95.0|2.29|68.45||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||68.45|2.29|
91702339|NCT00772005|183299659|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
91494784|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0087|TWO_SIDED|95.0|0.7|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.7|0.0087
91494785|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0128|TWO_SIDED|95.0|0.6|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.6|0.0128
91494786|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1369|TWO_SIDED|95.0|-0.5|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||3.5|-0.5|0.1369
91494787|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6331|TWO_SIDED|95.0|-1.5|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||2.5|-1.5|0.6331
91494788|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0361|TWO_SIDED|95.0|0.1|4.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.3|0.1|0.0361
91494789|NCT00256750|182861158|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0525|TWO_SIDED|95.0|0.0|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.2|-0.0|0.0525
91494790|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.015|-0.032|<0.0001
91494791|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.019|||<|0.0001|TWO_SIDED|95.0|-0.028|-0.011||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.011|-0.028|<0.0001
91494792|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.014||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.014|-0.031|<0.0001
91494793|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.035|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.017|-0.035|<0.0001
91494794|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.016|-0.032|<0.0001
91733156|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733157|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91733158|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733159|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91733160|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733161|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91494795|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.029|-0.012||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.012|-0.029|<0.0001
91529394|NCT01380990|182934960|SUPERIORITY||Difference in percentages|28.33|||||TWO_SIDED|95.0|2.04|56.36||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||56.36|2.04|
91529395|NCT03192215|182934992|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.64|1.55|||Log Rank|||||1.55|0.64|0.99
91529396|NCT03192215|182934993|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.59|1.44|||Log Rank|||||1.44|0.59|0.72
91733162|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
91733163|NCT01098747|183361096|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
91759274|NCT00348309|183411457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.554|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||||0.5|-0.3|0.554
91759275|NCT00348309|183411458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.292
91529397|NCT03192215|182934994|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.76|1.52|||Log Rank|||||1.52|0.76|0.67
91529398|NCT03192215|182934995|SUPERIORITY||Difference of annual rate.|-0.011||||0.02|TWO_SIDED|95.0|-0.018|-0.003|||Exact Binomial Test|||||-0.003|-0.018|.02
91529399|NCT03192215|182934996|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||||3.52|0.29|0.98
91529400|NCT03192215|182934997|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.35|TWO_SIDED|95.0|0.63|3.75|||Log Rank|||||3.75|0.63|0.35
91529401|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-15.9|STANDARD_ERROR_OF_MEAN|7.76||0.362|TWO_SIDED|95.0|-31.2|-0.6|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||-0.6|-31.2|0.362
91529402|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-10.7|STANDARD_ERROR_OF_MEAN|7.12||0.729|TWO_SIDED|95.0|-24.8|3.3|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||3.3|-24.8|0.729
91529403|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-16.5|STANDARD_ERROR_OF_MEAN|4.73||0.173|TWO_SIDED|95.0|-25.8|-7.1|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B)||-7.1|-25.8|0.173
91733164|NCT01098747|183361097|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
91733165|NCT01098747|183361097|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.281|TWO_SIDED|95.0|0.79|2.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.22|0.79|0.281
91733166|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-23.93|||<|0.001|TWO_SIDED|95.0|-36.67|-11.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.20|-36.67|<0.001
91733167|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.483|TWO_SIDED|95.0|-4.12|1.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.70|-4.12|0.483
91733168|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-51.93|||<|0.001|TWO_SIDED|95.0|-65.63|-38.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.22|-65.63|<0.001
91733169|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-3.61||||0.174|TWO_SIDED|95.0|-7.97|0.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.75|-7.97|0.174
91733170|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-66.58|||<|0.001|TWO_SIDED|95.0|-79.8|-53.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.35|-79.80|<0.001
91529404|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-14.9|STANDARD_ERROR_OF_MEAN|3.25||0.185|TWO_SIDED|95.0|-21.3|-8.5|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B)||-8.5|-21.3|0.185
91529405|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-31.6|STANDARD_ERROR_OF_MEAN|7.71||0.02|TWO_SIDED|95.0|-46.9|-16.3|||ANCOVA|||140 micrograms of Tropifexor (Part C) vs placebo||-16.3|-46.9|0.020
91529406|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-32.5|STANDARD_ERROR_OF_MEAN|9.1||0.03|TWO_SIDED|95.0|-50.6|-14.5|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-14.5|-50.6|0.030
91529407|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.4|STANDARD_ERROR_OF_MEAN|7.86||0.456|TWO_SIDED|95.0|-26.3|-0.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A + B + C)||-0.4|-26.3|0.456
91529408|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.5|STANDARD_ERROR_OF_MEAN|7.27||0.966|TWO_SIDED|95.0|-19.5|4.4|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A + B + C)||4.4|-19.5|0.966
91529409|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.3|STANDARD_ERROR_OF_MEAN|4.93||0.275|TWO_SIDED|95.0|-21.4|-5.2|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.2|-21.4|0.275
91733171|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-3.75||||0.24|TWO_SIDED|95.0|-9.38|1.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.89|-9.38|0.240
91733172|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-61.36|||<|0.001|TWO_SIDED|95.0|-75.21|-47.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.50|-75.21|<0.001
91733173|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|1.52||||0.668|TWO_SIDED|95.0|-5.47|8.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.52|-5.47|0.668
91759276|NCT00348309|183411458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.297|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.297
91759277|NCT00348309|183411459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.598
91529410|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-11.8|STANDARD_ERROR_OF_MEAN|3.56||0.304|TWO_SIDED|95.0|-17.6|-5.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.9|-17.6|0.304
91529411|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) FAS|LS Mean change|-17.1|STANDARD_ERROR_OF_MEAN|4.45||0.057|TWO_SIDED|95.0|-24.5|-9.8|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A + B + C)||-9.8|-24.5|0.057
91733174|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-60.31|||<|0.001|TWO_SIDED|95.0|-74.28|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-74.28|<0.001
91733175|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|1.1||||0.98|TWO_SIDED|95.0|-7.44|7.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.63|-7.44|0.980
91733176|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-59.28|||<|0.001|TWO_SIDED|95.0|-73.05|-45.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.50|-73.05|<0.001
91733177|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|1.56||||0.711|TWO_SIDED|95.0|-6.68|9.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.81|-6.68|0.711
91733178|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-56.84|||<|0.001|TWO_SIDED|95.0|-70.84|-42.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.85|-70.84|<0.001
91733179|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|3.72||||0.445|TWO_SIDED|95.0|-5.94|13.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.38|-5.94|0.445
91759278|NCT00348309|183411459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.073|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.073
91759279|NCT00348309|183411460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.006|TWO_SIDED|95.0|0.02|0.12|||ANCOVA|||||0.12|0.02|0.006
91529412|NCT02855164|182935018|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B + C) FAS|LS Mean change|-23.0|STANDARD_ERROR_OF_MEAN|4.49||0.003|TWO_SIDED|95.0|-30.5|-15.6|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A + B + C)||-15.6|-30.5|0.003
91529413|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-9.9|STANDARD_ERROR_OF_MEAN|6.56||0.722|TWO_SIDED|95.0|-22.9|3.0|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||3.0|-22.9|0.722
91529414|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-2.2|STANDARD_ERROR_OF_MEAN|5.96||0.468|TWO_SIDED|95.0|-14.0|9.5|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||9.5|-14.0|0.468
91529415|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-8.8|STANDARD_ERROR_OF_MEAN|3.97||0.774|TWO_SIDED|95.0|-16.7|-1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B)||-1.0|-16.7|0.774
91529416|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.6|STANDARD_ERROR_OF_MEAN|2.76||0.136|TWO_SIDED|95.0|-6.0|4.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B)||4.9|-6.0|0.136
91529417|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-16.0|STANDARD_ERROR_OF_MEAN|3.97||0.145|TWO_SIDED|95.0|-23.9|-8.2|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Part C)||-8.2|-23.9|0.145
91759280|NCT00348309|183411460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.14|TWO_SIDED|95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.140
91759281|NCT00348309|183411470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.027|TWO_SIDED|95.0|-1.2|-0.1||Week 12|Mixed Models Analysis|||||-0.1|-1.2|0.027
91529418|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-15.3|STANDARD_ERROR_OF_MEAN|4.49||0.236|TWO_SIDED|95.0|-24.2|-6.4|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-6.4|-24.2|0.236
91529419|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.1|STANDARD_ERROR_OF_MEAN|7.0||0.788|TWO_SIDED|95.0|-18.7|4.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A+B+ C)||4.4|-18.7|0.788
91529420|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|0.4|STANDARD_ERROR_OF_MEAN|6.43||0.413|TWO_SIDED|95.0|-10.2|11.0|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A+B+ C)||11.0|-10.2|0.413
91529421|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-6.2|STANDARD_ERROR_OF_MEAN|4.38||0.833|TWO_SIDED|95.0|-13.4|1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B+ C)||1.0|-13.4|0.833
91494796|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.017|-0.034|<0.0001
91494797|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.025|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.016|-0.034|<0.0001
91529422|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|2.0|STANDARD_ERROR_OF_MEAN|3.19||0.068|TWO_SIDED|95.0|-3.2|7.3|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B+ C)||7.3|-3.2|0.068
91529423|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-0.1|STANDARD_ERROR_OF_MEAN|3.98||0.269|TWO_SIDED|95.0|-6.6|6.5|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A+B+ C)||6.5|-6.6|0.269
91529424|NCT02855164|182935019|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-3.8|STANDARD_ERROR_OF_MEAN|4.05||0.777|TWO_SIDED|95.0|-10.5|2.9|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A+B+ C)||2.9|-10.5|0.777
91529425|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-7.48|STANDARD_ERROR_OF_MEAN|6.174||0.853|TWO_SIDED|95.0|-19.66|4.7|||ANCOVA|||10 microgramsof Tropifexor - Change in percentage of fat in the liver Part A||4.70|-19.66|0.853
91529426|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-14.07|STANDARD_ERROR_OF_MEAN|5.661||0.232|TWO_SIDED|95.0|-25.24|-2.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Part A||-2.91|-25.24|0.232
91529427|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-15.04|STANDARD_ERROR_OF_MEAN|3.754||0.077|TWO_SIDED|95.0|-22.45|-7.64|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.64|-22.45|0.077
91529428|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline|LS Mean change|-12.34|STANDARD_ERROR_OF_MEAN|2.482||0.141|TWO_SIDED|95.0|-17.23|-7.44|||ANCOVA|||90 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.44|-17.23|0.141
91529429|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-31.25|STANDARD_ERROR_OF_MEAN|5.228|<|0.001|TWO_SIDED|95.0|-41.58|-20.92|||ANCOVA|||140 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-20.92|-41.58|<0.001
91529430|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-39.54|STANDARD_ERROR_OF_MEAN|4.968|<|0.001|TWO_SIDED|95.0|-49.37|-29.71|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-29.71|-49.37|<0.001
91733180|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|-52.79|||<|0.001|TWO_SIDED|95.0|-66.77|-38.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.81|-66.77|<0.001
91733181|NCT01098747|183361098|SUPERIORITY_OR_OTHER||Difference in proportion|6.05||||0.256|TWO_SIDED|95.0|-4.75|16.84||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.84|-4.75|0.256
91759282|NCT00348309|183411470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.091|TWO_SIDED|95.0|-1.1|0.1||Week 12|Mixed Models Analysis|||||0.1|-1.1|0.091
91494798|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.013|-0.030|<0.0001
91529431|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-8.09|STANDARD_ERROR_OF_MEAN|6.65||0.872|TWO_SIDED|95.0|-19.06|2.88|||ANCOVA|||10 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||2.88|-19.06|0.872
91529432|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-14.14|STANDARD_ERROR_OF_MEAN|6.198||0.465|TWO_SIDED|95.0|-24.36|-3.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-3.91|-24.36|0.465
91529433|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-15.02|STANDARD_ERROR_OF_MEAN|4.078||0.228|TWO_SIDED|95.0|-21.75|-8.29|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-8.29|-21.75|0.228
91529434|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-12.56|STANDARD_ERROR_OF_MEAN|2.717||0.37|TWO_SIDED|95.0|-17.04|-8.08|||ANCOVA|||90 micrograms - Change in percentage of fat in the liver Parts A+B+C||-8.08|-17.04|0.370
91529435|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-18.71|STANDARD_ERROR_OF_MEAN|3.517||0.029|TWO_SIDED|95.0|-24.51|-12.91|||ANCOVA|||140 micrograms - Change in percentage of fat in the liver Parts A+B+C||-12.91|-24.51|0.029
91529436|NCT02855164|182935020|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-34.38|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-40.13|-28.64|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-28.64|-40.13|<0.001
91733182|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|6.34||||0.078|TWO_SIDED|95.0|1.34|11.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.34|1.34|0.078
91494799|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.015|||<|0.0001|TWO_SIDED|95.0|-0.024|-0.007||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.007|-0.024|<0.0001
91733183|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|2.74||||0.303|TWO_SIDED|95.0|-3.01|8.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.49|-3.01|0.303
91733184|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|27.24|||<|0.001|TWO_SIDED|95.0|18.14|36.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.34|18.14|<0.001
91733185|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|6.66||||0.217|TWO_SIDED|95.0|-4.31|17.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.63|-4.31|0.217
91733186|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|41.16|||<|0.001|TWO_SIDED|95.0|31.2|51.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.12|31.20|<0.001
91733187|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|8.86||||0.149|TWO_SIDED|95.0|-3.33|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.33|0.149
91494800|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.015|-0.031|<0.0001
91494801|NCT00256750|182861159|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.013|-0.030|<0.0001
91529437|NCT02855164|182935021|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.79|STANDARD_ERROR_OF_MEAN|0.608||0.01|TWO_SIDED|95.0|-2.99|0.59|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.59|-2.99|0.010
91733188|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|48.61|||<|0.001|TWO_SIDED|95.0|38.49|58.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||58.73|38.49|<0.001
91733189|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|4.55||||0.477|TWO_SIDED|95.0|-8.03|17.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.13|-8.03|0.477
91733190|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|52.81|||<|0.001|TWO_SIDED|95.0|42.63|62.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.99|42.63|<0.001
91733191|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|-2.14||||0.739|TWO_SIDED|95.0|-14.77|10.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-14.77|0.739
91759283|NCT00348309|183411470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.268|TWO_SIDED|95.0|-1.1|0.3||Week 36|Mixed Models Analysis|||||0.3|-1.1|0.268
91494802|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4498|TWO_SIDED|95.0|-1.2|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.7|-1.2|0.4498
91759284|NCT00348309|183411470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.318|TWO_SIDED|95.0|-1.1|0.4||Week 36|Mixed Models Analysis|||||0.4|-1.1|0.318
91759285|NCT00348309|183411470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03|TWO_SIDED|95.0|-1.6|-0.1||Week 48|Mixed Models Analysis|||||-0.1|-1.6|0.030
91494803|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0584|TWO_SIDED|95.0|-0.1|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.1|0.0584
91494804|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.1595|TWO_SIDED|95.0|-0.5|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||2.7|-0.5|0.1595
91494805|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0457|TWO_SIDED|95.0|0.0|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.3|0.0|0.0457
91494806|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1729|TWO_SIDED|95.0|-0.6|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||3.2|-0.6|0.1729
91494807|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4209|TWO_SIDED|95.0|-1.1|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.7|-1.1|0.4209
91494808|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0526|TWO_SIDED|95.0|0.0|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.2|-0.0|0.0526
91494809|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0077|TWO_SIDED|95.0|0.6|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.9|0.6|0.0077
91494810|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.1849|TWO_SIDED|95.0|-0.6|3.4|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.6|0.1849
91494811|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4633|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.8|-1.3|0.4633
91494812|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.0971|TWO_SIDED|95.0|-0.3|3.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.0|-0.3|0.0971
91494813|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0102|TWO_SIDED|95.0|0.5|3.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.8|0.5|0.0102
91494814|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0186|TWO_SIDED|95.0|0.4|4.5|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.5|0.4|0.0186
91494815|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0775|TWO_SIDED|95.0|-0.2|4.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.0|-0.2|0.0775
91494816|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0768|TWO_SIDED|95.0|-0.2|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.3|-0.2|0.0768
91494817|NCT00256750|182861160|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.1876|TWO_SIDED|95.0|-0.6|2.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||2.9|-0.6|0.1876
91529438|NCT02855164|182935021|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-0.78|STANDARD_ERROR_OF_MEAN|0.567||0.237|TWO_SIDED|95.0|-1.9|0.34|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.34|-1.90|0.237
91529439|NCT02855164|182935021|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.05|STANDARD_ERROR_OF_MEAN|0.377||0.037|TWO_SIDED|95.0|-1.8|0.31|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.31|-1.80|0.037
91733192|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
91733193|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|-6.8||||0.28|TWO_SIDED|95.0|-19.24|5.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.65|-19.24|0.280
91529440|NCT02855164|182935021|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.15|STANDARD_ERROR_OF_MEAN|0.253||0.007|TWO_SIDED|95.0|-1.65|0.65|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.65|-1.65|0.007
91529441|NCT02855164|182935021|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.1|STANDARD_ERROR_OF_MEAN|0.988||0.053|TWO_SIDED|95.0|-7.05|-3.14|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-3.14|-7.05|0.053
91529442|NCT02855164|182935021|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.89|STANDARD_ERROR_OF_MEAN|1.002||0.013|TWO_SIDED|95.0|-7.87|-3.91|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-3.91|-7.87|0.013
91529443|NCT02855164|182935022|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.64|STANDARD_ERROR_OF_MEAN|0.208||0.006|TWO_SIDED|95.0|-1.05|0.23|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.23|-1.05|0.006
91529444|NCT02855164|182935022|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.29|STANDARD_ERROR_OF_MEAN|0.194||0.177|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.09|-0.67|0.177
91529445|NCT02855164|182935022|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-0.35|STANDARD_ERROR_OF_MEAN|0.129||0.032|TWO_SIDED|95.0|-0.61|0.1|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.10|-0.61|0.032
91529446|NCT02855164|182935022|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.42|STANDARD_ERROR_OF_MEAN|0.087||0.003|TWO_SIDED|95.0|-0.59|0.25|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.25|-0.59|0.003
91529447|NCT02855164|182935022|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-1.88|STANDARD_ERROR_OF_MEAN|0.322||0.015|TWO_SIDED|95.0|-2.51|-1.24|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-1.24|-2.51|0.015
91529448|NCT02855164|182935022|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-2.11|STANDARD_ERROR_OF_MEAN|0.327||0.004|TWO_SIDED|95.0|-2.75|-1.46|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-1.46|-2.75|0.004
91529449|NCT02855164|182935023|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.53|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.03|0.530
91529450|NCT02855164|182935023|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.008||0.857|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.02|0.857
91529451|NCT02855164|182935023|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.005||0.262|TWO_SIDED|95.0|-0.02|0.0|||Mixed Models Analysis|||60 micrograms of Tropifexor (Part A) vs Placebo||0.00|-0.02|0.262
91529452|NCT02855164|182935023|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.323|TWO_SIDED|95.0|0.0|0.01|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.01|0.00|0.323
91529453|NCT02855164|182935023|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.1|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||0.01|-0.02|0.100
91529454|NCT02855164|182935023|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.007||0.693|TWO_SIDED|95.0|-0.03|0.0|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||0.00|-0.03|0.693
91529455|NCT02855164|182935035|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.223|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.223|-0.214|1.0000
91529456|NCT02855164|182935035|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.251|-0.196|0.8074
91529457|NCT02855164|182935036|SUPERIORITY||Risk Difference (RD)|0.028||||0.807|TWO_SIDED|95.0|-0.191|0.246|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.246|-0.191|0.8070
91529458|NCT02855164|182935036|SUPERIORITY||Risk Difference (RD)|0.052||||0.6233|TWO_SIDED|95.0|-0.173|0.273|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.273|-0.173|0.6233
91529459|NCT02855164|182935037|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.233|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.233|-0.214|1.0000
91733194|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
91733195|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|-8.01||||0.202|TWO_SIDED|95.0|-20.44|4.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.41|-20.44|0.202
91733196|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
91733197|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|-8.61||||0.17|TWO_SIDED|95.0|-21.02|3.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.80|-21.02|0.170
91733198|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
91733199|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
91733200|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
91733201|NCT01098747|183361099|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
91733202|NCT01098747|183361100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.83|0.98||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.98|0.83|<0.001
91733203|NCT01098747|183361100|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.667|TWO_SIDED|95.0|-0.15|0.24||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.24|-0.15|0.667
91733204|NCT00600340|183361116|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.042||||0.1983|ONE_SIDED|97.5||1.689||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.689||0.1983
91733205|NCT00600340|183361116|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.018||||0.007|ONE_SIDED|97.5||1.261||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.261||0.0070
91733206|NCT00600340|183361116|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.2024|ONE_SIDED|97.5||1.674||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.674||0.2024
91759286|NCT00348309|183411470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.797|TWO_SIDED|95.0|-0.9|0.7||Week 48|Mixed Models Analysis|||||0.7|-0.9|0.797
91494818|NCT00256750|182861162|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|4.2|||||TWO_SIDED|97.3|-1.3|10.1||||||Month 24||10.1|-1.3|
91494819|NCT00256750|182861162|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.6|||||TWO_SIDED|97.3|-2.2|9.6||||||Month 24||9.6|-2.2|
91494820|NCT00256750|182861162|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.3|||||TWO_SIDED|97.3|-2.9|9.8||||||Month 36||9.8|-2.9|
91494821|NCT00256750|182861162|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.5|||||TWO_SIDED|97.3|-2.8|10.0||||||||10.0|-2.8|
91494822|NCT00256750|182861163|SUPERIORITY_OR_OTHER||Difference in Percent|5.9|||||TWO_SIDED|95.0|-1.0|12.8||||||Month 12||12.8|-1.0|
91529460|NCT02855164|182935037|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.251|-0.196|0.8074
91529461|NCT02855164|182935038|SUPERIORITY||Risk Difference (RD)|0.034||||0.7028|TWO_SIDED|95.0|-0.184|0.252|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.252|-0.184|0.7028
91529462|NCT02855164|182935038|SUPERIORITY||Risk Difference (RD)|0.129||||0.1713|TWO_SIDED|95.0|-0.098|0.345|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.345|-0.098|0.1713
91529463|NCT02855164|182935039|SUPERIORITY||Risk Difference (RD)|0.057||||0.2033|TWO_SIDED|95.0|-0.168|0.278|||Mixed Models Analysis|||Resolution of steatohepatitis (FDA, EMA) without worsening of fibrosis (NASH CRN staging)||0.278|-0.168|0.2033
91529464|NCT00654940|182935061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.305||||80.0|-1.21|-0.41|||ANCOVA|||Treatment comparison of pregabalin - placebo: mixed effects analysis of covariance model fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect, and baseline was fitted as two covariates.||-0.41|-1.21|
91529465|NCT00654940|182935062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.493||||80.0|-3.82|2.78|||ANCOVA|||Neuropathic Pain Symptom Inventory treatment comparison: Pregabalin - Placebo. Total score was analyzed using a mixed effect analysis of covariance model based on the full analysis set (FAS), accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||2.78|-3.82|
91529466|NCT00654940|182935063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29000.0|STANDARD_ERROR_OF_MEAN|17000.0||||80.0|6100.0|51000.0|||ANCOVA|||Difference in least squares means Pregabalin-Placebo. Model of day (8 am to 8 pm) total activity score at end of treatment. Mixed effects analysis of covariance model was fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||51000|6100|
91759287|NCT00622388|183411471|SUPERIORITY_OR_OTHER||Response rate|11.0|||||TWO_SIDED|95.0|5.0|20.0|||||Response rate is calculated as the number of responses divided by the number of participants treated, expressed as a percentage.|||20|5|
91759288|NCT00516165|183411532|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kaplan Meier|||||||0.05
91494823|NCT00256750|182861163|SUPERIORITY_OR_OTHER||Difference in Percent|11.5|||||TWO_SIDED|95.0|4.2|18.9||||||Month 12||18.9|4.2|
91494824|NCT00256750|182861163|SUPERIORITY_OR_OTHER||Difference in Percent|1.8|||||TWO_SIDED|95.0|-5.5|9.1||||||Month 24||9.1|-5.5|
91494825|NCT00256750|182861163|SUPERIORITY_OR_OTHER||Difference in Percent|9.8|||||TWO_SIDED|95.0|1.9|17.6||||||Month 24||17.6|1.9|
91494826|NCT00256750|182861163|SUPERIORITY_OR_OTHER||Difference in Percent|0.9|||||TWO_SIDED|95.0|-6.6|8.4||||||Month 36||8.4|-6.6|
91529467|NCT01682538|182935083|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.858|||||TWO_SIDED|90.0|0.81|0.91|||ANOVA|||||0.91|0.81|
91529468|NCT01682538|182935084|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.954|||||TWO_SIDED|90.0|0.85|1.07|||ANOVA|||||1.07|0.85|
91529469|NCT01682538|182935085|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25).|Ratio of geometric means|1.013|||||TWO_SIDED|90.0|0.96|1.07|||ANOVA|||||1.07|0.96|
91529470|NCT01682538|182935086|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25)|Ratio of geometric means|0.802|||||TWO_SIDED|90.0|0.71|0.9|||ANOVA|||||0.90|0.71|
91702340|NCT00772005|183299659|SUPERIORITY_OR_OTHER|||||||0.0883||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0883
91759289|NCT00516165|183411533|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
91494827|NCT00256750|182861163|SUPERIORITY_OR_OTHER||Difference in Percent|8.4|||||TWO_SIDED|95.0|0.4|16.4||||||Month 36||16.4|0.4|
91494828|NCT04659161|182861173|SUPERIORITY||LS mean difference|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.9|-5.2|||Mixed Model for Repeated Measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-5.2|-13.9|<0.0001
91733207|NCT00600340|183361116|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.134||||0.0612|ONE_SIDED|97.5||1.386||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.386||0.0612
91733208|NCT00600340|183361117|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.027||||0.1534|ONE_SIDED|97.5||1.606||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.606||0.1534
91733209|NCT00600340|183361117|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.035||||0.0085|ONE_SIDED|97.5||1.273||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.273||0.0085
91733210|NCT00600340|183361117|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.1778|ONE_SIDED|97.5||1.623||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.623||0.1778
91733211|NCT00600340|183361117|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.126||||0.049|ONE_SIDED|97.5||1.37||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.37||0.049
91733212|NCT00600340|183361123|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR) of objective response and Cochran-Mantel-Haenszel (CMH) test (stratified)||0.67|0.33|< 0.0001
91733213|NCT00600340|183361123|SUPERIORITY||Risk Difference (RD)|-17.0|||||TWO_SIDED|95.0|-24.0|-9.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-9|-24|
91733214|NCT00600340|183361123|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
91733215|NCT00600340|183361123|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
91733216|NCT00600340|183361124|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.65|0.31|< 0.0001
91733217|NCT00600340|183361124|SUPERIORITY||Risk Difference (RD)|-18.0|||||TWO_SIDED|95.0|-26.0|-10.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-10|-26|
91494829|NCT04659161|182861174|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
91494830|NCT04659161|182861175|SUPERIORITY|||||||0.0055|||||||Mixed Model Repeated Measures|||||||0.0055
91494831|NCT04659161|182861176|SUPERIORITY|||||||0.0022|||||||Mixed Model for Repeated Measures|||||||0.0022
91494832|NCT04659161|182861177|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
91494833|NCT04659161|182861178|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
91494834|NCT02197130|182861187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.192||0.2033|TWO_SIDED|90.0|-0.45|3.49|||MMRM|MMRM: A linear mixed-effect repeated measures model||||3.49|-0.45|0.2033
91494835|NCT02197130|182861187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|1.118||0.7549|TWO_SIDED|90.0|-2.2|1.5|||MMRM|||||1.50|-2.20|0.7549
91759290|NCT00516165|183411534|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
91494836|NCT02197130|182861199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|0.515||0.003|TWO_SIDED|90.0|0.69|2.39|||MMRM|||Week 13||2.39|0.69|0.0030
91494837|NCT02197130|182861199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.491||0.4656|TWO_SIDED|90.0|-0.45|1.17|||MMRM|||Week 13||1.17|-0.45|0.4656
91494838|NCT02197130|182861199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21|STANDARD_ERROR_OF_MEAN|0.492||0.0149|TWO_SIDED|90.0|0.39|2.02|||MMRM|||Week 26||2.02|0.39|0.0149
91494839|NCT02197130|182861199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8233|TWO_SIDED|90.0|-0.66|0.86|||MMRM|||Week 26||0.86|-0.66|0.8233
91759291|NCT00516165|183411535|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
91759292|NCT00516165|183411536|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
91759293|NCT00516165|183411537|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
91759294|NCT00061633|183411541|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.||||||0.5289|||||||2-sided 95% confidence interval|||95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference||||0.5289
91759295|NCT01431963|183411542|SUPERIORITY_OR_OTHER||percentage of participants|43.1|||||TWO_SIDED|95.0|30.85|55.96|||||The estimated value reflects the percentage of participants who were seizure free for all seizures.|||55.96|30.85|
91759296|NCT01431963|183411542|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.02|54.09|||||The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.|||54.09|27.02|
91759297|NCT01431963|183411542|SUPERIORITY_OR_OTHER||percentage of participants|40.5|||||TWO_SIDED|95.0|25.63|56.72|||||The estimated value reflects the percentage of participants who were seizure free for A+B seizures.|||56.72|25.63|
91759298|NCT01431963|183411542|SUPERIORITY_OR_OTHER||percentage of participants|69.7|||||TWO_SIDED|95.0|51.29|84.41|||||The estimated value reflects the percentage of participants who were seizure free for C seizures.|||84.41|51.29|
91759299|NCT01431963|183411542|SUPERIORITY_OR_OTHER||percentage of participants|80.0|||||TWO_SIDED|95.0|44.39|97.48|||||The estimated value reflects the percentage of participants who were seizure free for D5 seizures.|||97.48|44.39|
91759300|NCT04254666|183411549|OTHER||||||||||||||||||pre and post scores for this measure are presented as the percent of foods correctly classified.|||
91759301|NCT01865448|183411625|SUPERIORITY_OR_OTHER|||||||0.278|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2780
91759302|NCT01865448|183411625|SUPERIORITY_OR_OTHER|||||||0.8689|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8689
91759303|NCT01865448|183411625|SUPERIORITY_OR_OTHER|||||||0.4533|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4533
91759304|NCT01865448|183411626|SUPERIORITY_OR_OTHER|||||||0.71833|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.71833
91759305|NCT01865448|183411626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759306|NCT01865448|183411626|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759307|NCT01865448|183411627|SUPERIORITY_OR_OTHER|||||||0.519|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.51900
91759308|NCT01865448|183411627|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759309|NCT01865448|183411627|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759310|NCT01865448|183411628|SUPERIORITY_OR_OTHER|||||||0.24567|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24567
91759311|NCT01865448|183411628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759312|NCT01865448|183411628|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759313|NCT01865448|183411629|SUPERIORITY_OR_OTHER|||||||0.9573|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9573
91759314|NCT01865448|183411629|SUPERIORITY_OR_OTHER|||||||0.5257|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5257
91759315|NCT01865448|183411629|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0657
91759316|NCT01865448|183411630|SUPERIORITY_OR_OTHER|||||||0.7474|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7474
91759317|NCT01865448|183411630|SUPERIORITY_OR_OTHER|||||||0.3745|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3745
91759318|NCT01865448|183411630|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0476
91759319|NCT01865448|183411631|SUPERIORITY_OR_OTHER|||||||0.27444|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.27444
91759320|NCT01865448|183411631|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759321|NCT01865448|183411631|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759322|NCT01865448|183411632|SUPERIORITY_OR_OTHER|||||||0.28489|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28489
91759323|NCT01865448|183411632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759324|NCT01865448|183411632|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
91759325|NCT01865448|183411633|SUPERIORITY_OR_OTHER|||||||0.04491|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.04491
91702341|NCT00772005|183299660|SUPERIORITY_OR_OTHER|||||||0.6948||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6948
91702342|NCT00772005|183299660|SUPERIORITY_OR_OTHER|||||||0.3345||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3345
91702343|NCT00772005|183299660|SUPERIORITY_OR_OTHER|||||||0.2447||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2447
91702344|NCT00772005|183299661|SUPERIORITY_OR_OTHER|||||||0.6115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6115
91702345|NCT00772005|183299661|SUPERIORITY_OR_OTHER|||||||0.2233||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2233
91702346|NCT00772005|183299661|SUPERIORITY_OR_OTHER|||||||0.2343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2343
91702347|NCT00772005|183299662|SUPERIORITY_OR_OTHER|||||||0.8228||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8228
91702348|NCT00772005|183299662|SUPERIORITY_OR_OTHER|||||||0.9373||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9373
91702349|NCT00772005|183299662|SUPERIORITY_OR_OTHER|||||||0.319||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3190
91702350|NCT00772005|183299663|SUPERIORITY_OR_OTHER|||||||0.9769||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9769
91702351|NCT00772005|183299663|SUPERIORITY_OR_OTHER|||||||0.8374||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8374
91702352|NCT00772005|183299663|SUPERIORITY_OR_OTHER|||||||0.7061||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7061
91702353|NCT00772005|183299664|SUPERIORITY_OR_OTHER|||||||0.9577||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9577
91702354|NCT00772005|183299664|SUPERIORITY_OR_OTHER|||||||0.5106||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5106
91702355|NCT00772005|183299664|SUPERIORITY_OR_OTHER|||||||0.2655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2655
91702356|NCT00772005|183299665|SUPERIORITY_OR_OTHER|||||||0.3825||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3825
91702357|NCT00772005|183299665|SUPERIORITY_OR_OTHER|||||||0.2003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2003
91702358|NCT00772005|183299665|SUPERIORITY_OR_OTHER|||||||0.0625||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0625
91702359|NCT00772005|183299666|SUPERIORITY_OR_OTHER|||||||0.2981||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2981
91702360|NCT00772005|183299666|SUPERIORITY_OR_OTHER|||||||0.0104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0104
91702361|NCT00772005|183299666|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0150
91702362|NCT00772005|183299667|SUPERIORITY_OR_OTHER|||||||0.4608||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4608
91529471|NCT00777803|182935104|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.|difference of response rates|0.7|||||TWO_SIDED|95.0|-3.2|7.1|||||Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)|Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).||7.1|-3.2|
91529472|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.99|1.43|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.||1.43|0.99|
91529473|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.21|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.||1.21|0.84|
91494840|NCT02197130|182861201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.148||0.0181|TWO_SIDED|90.0|0.11|0.6|||MMRM|||Week 13||0.60|0.11|0.0181
91529474|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.51|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.||1.51|0.93|
91733218|NCT00600340|183361124|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
91733219|NCT00600340|183361124|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
91733220|NCT00600340|183361125|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.63|0.31|< 0.0001
91733221|NCT00600340|183361125|SUPERIORITY||Risk Difference (RD)|-20.0|||||TWO_SIDED|95.0|-28.0|-11.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-11|-28|
91733222|NCT00600340|183361125|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
91733223|NCT00600340|183361125|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
91733224|NCT00600340|183361126|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.60|0.29|< 0.0001
91733225|NCT00600340|183361126|SUPERIORITY||Risk Difference (RD)|-21.0|||||TWO_SIDED|95.0|-30.0|-13.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-13|-30|
91733226|NCT00600340|183361126|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
91733227|NCT00600340|183361126|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
91494841|NCT02197130|182861201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7133|TWO_SIDED|90.0|-0.18|0.28|||MMRM|||Week 13||0.28|-0.18|0.7133
91494842|NCT02197130|182861201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.163||0.4657|TWO_SIDED|90.0|-0.15|0.39|||MMRM|||Week 26||0.39|-0.15|0.4657
91494843|NCT02197130|182861201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.15||0.8339|TWO_SIDED|90.0|-0.22|0.28|||MMRM|||Week 26||0.28|-0.22|0.8339
91529475|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.83|||||TWO_SIDED|95.0|0.66|1.06|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.||1.06|0.66|
91529476|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.||1.64|0.97|
91529477|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.||1.07|0.63|
91529478|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.24|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.||1.24|0.89|
91529479|NCT01755689|182935118|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.||1.12|0.80|
91529480|NCT01755689|182935119|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.15|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.||1.15|0.81|
91529481|NCT01755689|182935119|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.||1.29|0.92|
91529482|NCT01755689|182935119|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.2|||||TWO_SIDED|95.0|1.01|1.43|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.||1.43|1.01|
91529483|NCT01755689|182935119|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.19|||||TWO_SIDED|95.0|1.0|1.41|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.||1.41|1.00|
91529484|NCT01755689|182935120|NON_INFERIORITY|For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-2.88|||||TWO_SIDED|95.0|-6.9|0.81||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.||0.81|-6.90|
91529485|NCT01755689|182935120|NON_INFERIORITY|For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-0.4|||||TWO_SIDED|95.0|-2.23|1.08||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.||1.08|-2.23|
91529486|NCT01755689|182935121|NON_INFERIORITY|For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.53|||||TWO_SIDED|95.0|1.25|1.87|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.||1.87|1.25|
91529487|NCT01755689|182935121|NON_INFERIORITY|For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.65|||||TWO_SIDED|95.0|1.42|1.93|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.||1.93|1.42|
91529488|NCT01755689|182935121|NON_INFERIORITY|For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.||1.61|1.20|
91529489|NCT02609659|182935154|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 92% to achieve noninferiority.|percentage of participants|89.5|||||TWO_SIDED|95.0|83.7|95.4||||||||95.4|83.7|
91529490|NCT00377741|182935192|SUPERIORITY_OR_OTHER||Mean exposure ratio for AUC(0-tau)|1.24|||||TWO_SIDED|90.0|0.98|1.55||||||||1.55|0.98|
91529491|NCT00377741|182935193|SUPERIORITY_OR_OTHER||Mean exposure ratio for Cmax|1.12|||||TWO_SIDED|90.0|0.88|1.42||||||||1.42|0.88|
91529492|NCT01115998|182935206|SUPERIORITY_OR_OTHER|||||||0.02||||||The a priori alpha level was \< 0.10 and was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.02
91759326|NCT01865448|183411633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759327|NCT01865448|183411633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759328|NCT01865448|183411634|SUPERIORITY_OR_OTHER|||||||0.24396|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24396
91733228|NCT00600340|183361127|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.32||||0.0066|TWO_SIDED|95.0|1.08|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.08|0.0066
91733229|NCT00600340|183361128|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.31||||0.0094|TWO_SIDED|95.0|1.07|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.07|0.0094
91733230|NCT00600340|183361129|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.13||||0.1957|TWO_SIDED|95.0|0.94|1.35||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.35|0.94|0.1957
91733231|NCT00600340|183361130|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.11||||0.2583|TWO_SIDED|95.0|0.92|1.34||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.34|0.92|0.2583
91759329|NCT01865448|183411634|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
91494844|NCT02615145|182861208|SUPERIORITY|||||||0.111||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||||0.1110
91494845|NCT02615145|182861208|SUPERIORITY||difference in LS means|1.64||||0.2704|TWO_SIDED|95.0|-1.28|4.56||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||4.56|-1.28|0.2704
91494846|NCT02615145|182861208|SUPERIORITY||difference in LS means|-0.09||||0.9516|TWO_SIDED|95.0|-3.17|2.98||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||2.98|-3.17|0.9516
91494847|NCT02615145|182861208|SUPERIORITY||difference in LS means|-1.73||||0.0489|TWO_SIDED|95.0|-3.46|-0.01||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||-0.01|-3.46|0.0489
91494848|NCT02615145|182861208|SUPERIORITY|||||||0.9785||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||||0.9785
91494849|NCT02615145|182861208|SUPERIORITY||difference in LS means|-0.13||||0.9379|TWO_SIDED|95.0|-3.37|3.11||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.11|-3.37|0.9379
91494850|NCT02615145|182861208|SUPERIORITY||difference in LS means|0.07||||0.9678|TWO_SIDED|95.0|-3.33|3.47||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.47|-3.33|0.9678
91494851|NCT02615145|182861208|SUPERIORITY||difference in LS means|0.2||||0.8373|TWO_SIDED|95.0|-1.7|2.1||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||2.10|-1.70|0.8373
91494852|NCT02615145|182861208|SUPERIORITY||Mean Difference (Final Values)|6.37|||<|0.0001|TWO_SIDED|95.0|5.417|7.32|||paired t-test|paired t-test of whether difference in means is 0||Week 12 vs Baseline across all participants||7.320|5.417|< 0.0001
91494853|NCT02615145|182861208|SUPERIORITY||Mean Difference (Final Values)|10.15|||<|0.0001|TWO_SIDED|95.0|8.936|11.362|||paired t-test|paired t-test of whether difference in means is 0||Week 48 vs Baseline across all participants||11.362|8.936|< 0.0001
91494854|NCT02615145|182861213|SUPERIORITY|||||||0.5751||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EOT||||0.5751
91494855|NCT02615145|182861213|SUPERIORITY||difference in LS means|2.29||||0.5176|TWO_SIDED|95.0|-4.66|9.23||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||9.23|-4.66|0.5176
91494856|NCT02615145|182861213|SUPERIORITY||difference in LS means|0.324||||0.9308|TWO_SIDED|95.0|-7.0|7.64||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||7.64|-7.00|0.9308
91494857|NCT02615145|182861213|SUPERIORITY||difference in LS means|-1.96||||0.3462|TWO_SIDED|95.0|-6.06|2.13||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||2.13|-6.06|0.3462
91494858|NCT02615145|182861213|SUPERIORITY|||||||0.7016||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 Weeks after EoT||||0.7016
91529493|NCT01115998|182935206|SUPERIORITY_OR_OTHER|||||||0.52||||||The a priori alpha level was \<0.10 and was not adjusted for multiple comparisons|Wilcoxon Signed-Rank Test|||"Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.52
91529494|NCT01115998|182935206|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
91494859|NCT02615145|182861213|SUPERIORITY||difference in LS means|-2.61||||0.4002|TWO_SIDED|95.0|-8.71|3.49||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.49|-8.71|0.4002
91494860|NCT02615145|182861213|SUPERIORITY||difference in LS means|-2.33||||0.475|TWO_SIDED|95.0|-8.74|4.08||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||4.08|-8.74|0.4750
91494861|NCT02615145|182861213|SUPERIORITY||difference in LS means|0.282||||0.874|TWO_SIDED|95.0|-3.21|3.77||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.77|-3.21|0.8740
91494862|NCT02615145|182861213|SUPERIORITY|||||||0.7211||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||||0.7211
91494863|NCT02615145|182861213|SUPERIORITY||difference in LS means|-3.67||||0.4256|TWO_SIDED|95.0|-12.7|5.39||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.39|-12.7|0.4256
91494864|NCT02615145|182861213|SUPERIORITY||difference in LS means|-3.01||||0.5347|TWO_SIDED|95.0|-12.6|6.54||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||6.54|-12.6|0.5347
91494865|NCT02615145|182861213|SUPERIORITY||difference in LS means|0.654||||0.792|TWO_SIDED|95.0|-4.23|5.54||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.54|-4.23|0.7920
91494866|NCT02615145|182861213|SUPERIORITY||Mean Difference (Final Values)|5.64|||<|0.0001|TWO_SIDED|95.0|3.355|7.935|||paired t-test|paired t-test of mean difference from 0||Baseline to EOT across all participants||7.935|3.355|< 0.0001
91494867|NCT02615145|182861213|SUPERIORITY||Mean Difference (Final Values)|10.21|||<|0.0001|TWO_SIDED|95.0|8.113|12.299|||paired t-test|paired t-test of mean difference versus 0||Baseline vs 12 weeks after EOT across all participants||12.299|8.113|< 0.0001
91494868|NCT02615145|182861213|SUPERIORITY||Mean Difference (Final Values)|10.13|||<|0.0001|TWO_SIDED|95.0|7.259|12.992|||paired t-test|paired t-test of mean difference versus 0||baseline vs 48 weeks after EOT across all participants||12.992|7.259|< 0.0001
91494869|NCT02615145|182861214|SUPERIORITY|||||||0.3869||||||Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||||0.3869
91494870|NCT02615145|182861214|SUPERIORITY||difference in LS means|-1.89||||0.3125|TWO_SIDED|95.0|-5.57|1.79||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.79|-5.57|0.3125
91494871|NCT02615145|182861214|SUPERIORITY||difference in LS means|-2.65||||0.1741|TWO_SIDED|95.0|-6.48|1.18||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.18|-6.48|0.1741
91494872|NCT02615145|182861214|SUPERIORITY||difference in LS means|-0.76||||0.4941|TWO_SIDED|95.0|-2.94|1.42||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.42|-2.94|0.4941
91494873|NCT02615145|182861214|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8842|TWO_SIDED|95.0|-1.271|1.096|||paired t-test|paired t-test of mean difference vs 0||Change from Baseline to Final visit across all participants||1.096|-1.271|0.8842
91494874|NCT00006237|182861218|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Log Rank|||||||0.49
91494875|NCT00006237|182861219|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||||||0.02
91494876|NCT02320669|182861224|SUPERIORITY||Cox Proportional Hazard|1.083|||<|0.05|TWO_SIDED|95.0|0.82|1.432|||Regression, Cox|||||1.432|.82|<.05
91494877|NCT01600638|182861230|OTHER||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|||||||||||||
91494878|NCT01600638|182861231|OTHER||sucess proportion|0.7823|||||TWO_SIDED|95.0|0.614|0.951||||||||0.951|0.614|
91494879|NCT00911820|182861249|SUPERIORITY|||||||0.714|||||||Log Rank|||||||0.714
91494880|NCT00911820|182861251|SUPERIORITY|||||||0.605|||||||Fisher Exact|||||||0.605
91494881|NCT00911820|182861252|SUPERIORITY|||||||0.721|||||||Log Rank|||||||0.721
91494882|NCT00583778|182861273|SUPERIORITY||Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using STATA 10 SE.Categorical variables were described using frequencies and relative frequencies. Distribution of continuous variables were evaluated for normality using the Shapiro-Walk test and graphically using histograms and box plots. Because most data were non-parametric, they were described using the median and 25th and 75th percentiles (interquartile range) and then compared using Wilcoxon rank sum test.|This study was designed to detect an absolute difference of 12 % in change of FEV-1percent predicted, with a standard deviation of 25% based on data provided to us from previous studies conducted by Sepracor. Based on this assumption, we sought to enter 76 patients in each group to have an 80% power to detect a 12 % absolute difference in charge of FEV-1 percent predicted over time at an alpha of 0.05. This accounted for a potential 10% dropout rate after randomization.|||< 0.05
91529495|NCT01115998|182935206|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.03
91494883|NCT01806545|182861318|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.11||||0.1197|TWO_SIDED|95.0|-0.242|0.025||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.025|-0.242|0.1197
91529496|NCT01115998|182935206|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Signed-Rank Test|The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.||"Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||.006
91529497|NCT01115998|182935206|SUPERIORITY_OR_OTHER|||||||0.45||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.45
91494884|NCT01806545|182861319|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.08||||0.1962|TWO_SIDED|95.0|-0.204|0.045||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.045|-0.204|0.1962
91494885|NCT01806545|182861320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||||||0.090
91759330|NCT01865448|183411634|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
91759331|NCT01865448|183411635|SUPERIORITY_OR_OTHER|||||||0.82322|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.82322
91759332|NCT01865448|183411635|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
91759333|NCT01865448|183411635|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
91759334|NCT01865448|183411636|SUPERIORITY_OR_OTHER|||||||0.76435|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.76435
91759335|NCT01865448|183411636|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
91759336|NCT01865448|183411636|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
91759337|NCT01865448|183411637|SUPERIORITY_OR_OTHER|||||||0.40485|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.40485
91759338|NCT01865448|183411637|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759339|NCT01865448|183411637|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759340|NCT01865448|183411638|SUPERIORITY_OR_OTHER|||||||0.13911|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.13911
91759341|NCT01865448|183411638|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
91759342|NCT01865448|183411638|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
91759343|NCT01865448|183411639|SUPERIORITY_OR_OTHER|||||||0.60214|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.60214
91759344|NCT01865448|183411639|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759345|NCT01865448|183411639|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759346|NCT01865448|183411640|SUPERIORITY_OR_OTHER|||||||0.66053|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.66053
91759347|NCT01865448|183411640|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759348|NCT01865448|183411640|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.05
91759349|NCT01865448|183411641|SUPERIORITY_OR_OTHER|||||||0.28743|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28743
91759350|NCT01865448|183411641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759351|NCT01865448|183411641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
91759352|NCT01865448|183411642|SUPERIORITY_OR_OTHER|||||||0.58561|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.58561
91759353|NCT01865448|183411642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
91759354|NCT01865448|183411642|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
91759355|NCT01865448|183411643|SUPERIORITY_OR_OTHER|||||||0.1953|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1953
91759356|NCT01865448|183411643|SUPERIORITY_OR_OTHER|||||||0.0351|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0351
91759357|NCT01865448|183411643|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0795
91759358|NCT01865448|183411644|SUPERIORITY_OR_OTHER|||||||0.6664|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6664
91759359|NCT01865448|183411644|SUPERIORITY_OR_OTHER|||||||0.431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4310
91759360|NCT01865448|183411644|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
91759361|NCT01865448|183411645|SUPERIORITY_OR_OTHER|||||||0.247|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2470
91759362|NCT01865448|183411645|SUPERIORITY_OR_OTHER|||||||0.2755|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2755
91759363|NCT01865448|183411645|SUPERIORITY_OR_OTHER|||||||0.8226|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.8226
91759364|NCT01865448|183411646|SUPERIORITY_OR_OTHER|||||||0.6779|||||||ANCOVA|||Between-Group Comparison||||0.6779
91529498|NCT01115998|182935207|SUPERIORITY_OR_OTHER|||||||0.92||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.92
91759365|NCT01865448|183411646|SUPERIORITY_OR_OTHER|||||||0.3761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3761
91759366|NCT01865448|183411646|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0281
91759367|NCT01865448|183411647|SUPERIORITY_OR_OTHER|||||||0.8591|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8591
91759368|NCT01865448|183411647|SUPERIORITY_OR_OTHER|||||||0.0404|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0404
91759369|NCT01865448|183411647|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0474
91759370|NCT01865448|183411648|SUPERIORITY_OR_OTHER|||||||0.3187|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3187
91759371|NCT01865448|183411648|SUPERIORITY_OR_OTHER|||||||0.0482|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0482
91759372|NCT01865448|183411648|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0394
91759373|NCT01865448|183411649|SUPERIORITY_OR_OTHER|||||||0.2813|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2813
91759374|NCT01865448|183411649|SUPERIORITY_OR_OTHER|||||||0.4421|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4421
91759375|NCT01865448|183411649|SUPERIORITY_OR_OTHER|||||||0.3198|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3198
91759376|NCT01865448|183411650|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2792
91759377|NCT01865448|183411650|SUPERIORITY_OR_OTHER|||||||0.1034|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1034
91759378|NCT01865448|183411650|SUPERIORITY_OR_OTHER|||||||0.9898|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.9898
91759379|NCT01865448|183411651|SUPERIORITY_OR_OTHER|||||||0.7047|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7047
91759380|NCT01865448|183411651|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4749
91759381|NCT01865448|183411651|SUPERIORITY_OR_OTHER|||||||0.6014|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.6014
91759382|NCT01865448|183411652|SUPERIORITY_OR_OTHER|||||||0.5932|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5932
91759383|NCT01865448|183411652|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.7140
91759384|NCT01865448|183411652|SUPERIORITY_OR_OTHER|||||||0.5827|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5827
91759385|NCT01865448|183411653|SUPERIORITY_OR_OTHER|||||||0.2894|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2894
91759386|NCT01865448|183411653|SUPERIORITY_OR_OTHER|||||||0.2128|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2128
91759387|NCT01865448|183411653|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0823
91494886|NCT01806545|182861321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Log Rank|P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.||Analysis of time to loss of patency||||0.193
91494887|NCT01806545|182861322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.231
91733232|NCT00600340|183361131|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.43|0.77||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.77|0.43|0.0001
91733233|NCT00600340|183361132|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.41|0.75||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.75|0.41|0.0001
91733234|NCT00600340|183361133|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.41||||0.0582|TWO_SIDED|95.0|0.99|2.02||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.02|0.99|0.0582
91733235|NCT00600340|183361134|SUPERIORITY|HR is the hazard rate of Arm B divided by hazard rate of Arm A.|Hazard Ratio (HR)|1.45||||0.0429|TWO_SIDED|95.0|1.01|2.1||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Arm B divided by hazard rate of Arm A.|"HR of Arm B vs. Arm A for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.10|1.01|0.0429
91733236|NCT00725985|183361141|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.248|0.584||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.584|0.248|<0.0001
91733237|NCT00725985|183361141|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.327|||<|0.0001|TWO_SIDED|95.0|0.21|0.509||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.509|0.210|< 0.0001
91733238|NCT00725985|183361142|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.331|0.547||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.547|0.331|< 0.0001
91733239|NCT00725985|183361142|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.497|||<|0.0001|TWO_SIDED|95.0|0.39|0.633||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.633|0.390|< 0.0001
91733240|NCT00725985|183361143|SUPERIORITY||Median Difference (Final Values)|-0.667|||<|0.0001|TWO_SIDED|95.0|-0.971|-0.5|||ANCOVA|||CUA lesions||-0.500|-0.971|<0.0001
91733241|NCT00725985|183361143|SUPERIORITY||Median Difference (Final Values)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.857|-0.429|||ANCOVA|||CUA lesions||-0.429|-0.857|<0.0001
91494888|NCT01806545|182861323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.158
91529499|NCT01115998|182935207|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
91733242|NCT00725985|183361143|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.333|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.333|<0.0001
91733243|NCT00725985|183361143|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.375|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.375|<0.0001
91733244|NCT00725985|183361143|SUPERIORITY||Median Difference (Final Values)|-0.333|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.167|||ANCOVA|||T2 Lesions||-0.167|-0.500|<0.0001
91733245|NCT00725985|183361143|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.429|-0.143|||ANCOVA|||T2 Lesions||-0.143|-0.429|<0.0001
91733246|NCT00725985|183361162|SUPERIORITY||Point Estimate|-1.7|||<|0.0001|TWO_SIDED|95.0|-37.2|0.0|||ANCOVA|||||0.000|-37.200|<0.0001
91733247|NCT00725985|183361162|SUPERIORITY||Point Estimate|-28.6|||<|0.0001|TWO_SIDED|95.0|-117.3|0.0|||ANCOVA|||||0.000|-117.300|<0.0001
91494889|NCT01806545|182861324|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.895|||||TWO_SIDED|95.0|-2.213|0.423||||||Treatment difference at week 12||0.423|-2.213|
91494890|NCT01806545|182861324|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.232|||||TWO_SIDED|95.0|-1.791|1.327||||||Treatment difference at week 26||1.327|-1.791|
91494891|NCT01806545|182861325|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.04|||||TWO_SIDED|95.0|-0.273|0.2||||||Analysis of week 12||0.200|-0.273|
91494892|NCT01806545|182861325|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|0.08|||||TWO_SIDED|95.0|-0.165|0.318||||||Analysis of week 26||0.318|-0.165|
91494893|NCT01806545|182861326|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.154|||||TWO_SIDED|95.0|-0.096|0.404||||||Analysis of week 12||0.404|-0.096|
91494894|NCT01806545|182861326|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.565|||||TWO_SIDED|95.0|-0.023|1.152||||||Analysis of week 26||1.152|-0.023|
91733248|NCT02546323|183361190|OTHER||Estimated mean difference|-0.0103|STANDARD_ERROR_OF_MEAN|0.00445||0.02|TWO_SIDED|95.0|-0.0191|-0.0016||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0016|-0.0191|0.020
91733249|NCT02546323|183361191|OTHER||Estimated mean difference|-0.011|STANDARD_ERROR_OF_MEAN|0.00442||0.013|TWO_SIDED|95.0|-0.0197|-0.0024||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0024|-0.0197|0.013
91733250|NCT02546323|183361192|OTHER||Estimated mean difference|-0.0162|STANDARD_ERROR_OF_MEAN|0.00903||0.073|TWO_SIDED|95.0|-0.0339|0.0015||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0015|-0.0339|0.073
91733251|NCT02546323|183361193|OTHER||Estimated mean difference|-0.0043|STANDARD_ERROR_OF_MEAN|0.00716||0.547|TWO_SIDED|95.0|-0.0183|0.0097||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0097|-0.0183|0.547
91733252|NCT02546323|183361194|OTHER||Estimated mean difference|-0.0086|STANDARD_ERROR_OF_MEAN|0.00272||0.002|TWO_SIDED|95.0|-0.0139|-0.0032||Statistical significance of the MeanMean CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients|Comparison of annualized rate of change in MeanMean CIMT measurement difference between rosuvastatin 20 mg and placebo||-0.0032|-0.0139|0.002
91733253|NCT02546323|183361195|OTHER||Least squares mean difference|-35.46|STANDARD_ERROR_OF_MEAN|2.426|<|0.001|TWO_SIDED|95.0|-40.23|-30.7|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-30.70|-40.23|<0.001
91733254|NCT02546323|183361195|OTHER||Least squares mean difference|-21.85|STANDARD_ERROR_OF_MEAN|1.441|<|0.001|TWO_SIDED|95.0|-24.68|-19.02|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-19.02|-24.68|<0.001
91733255|NCT02546323|183361195|OTHER||Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|1.347|<|0.001|TWO_SIDED|95.0|2.35|7.64|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||7.64|2.35|<0.001
91733256|NCT02546323|183361195|OTHER||Least squares mean difference|-19.65|STANDARD_ERROR_OF_MEAN|3.671|<|0.001|TWO_SIDED|95.0|-26.86|-12.44|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.44|-26.86|<0.001
91733257|NCT02546323|183361195|OTHER||Least squares mean difference|-29.49|STANDARD_ERROR_OF_MEAN|1.917|<|0.001|TWO_SIDED|95.0|-33.25|-25.72|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-25.72|-33.25|<0.001
91529500|NCT01115998|182935207|SUPERIORITY_OR_OTHER|||||||0.42||90.0||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.42
91733258|NCT02546323|183361195|OTHER||Least squares mean difference|-31.75|STANDARD_ERROR_OF_MEAN|2.334|<|0.001|TWO_SIDED|95.0|-36.33|-27.16|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-27.16|-36.33|<0.001
91733259|NCT02546323|183361195|OTHER||Least squares mean difference|-26.12|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-29.73|-22.5|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB||-22.50|-29.73|<0.001
91759388|NCT01865448|183411654|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|||Between-Group Comparison||||0.3450
91759389|NCT01865448|183411654|SUPERIORITY_OR_OTHER|||||||0.1365|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1365
91759390|NCT01865448|183411654|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0073
91759391|NCT01865448|183411655|SUPERIORITY_OR_OTHER|||||||0.2333|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2333
91759392|NCT01865448|183411655|SUPERIORITY_OR_OTHER|||||||0.4292|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4292
91759393|NCT01865448|183411655|SUPERIORITY_OR_OTHER|||||||0.3356|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3356
91759394|NCT01865448|183411656|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6830
91529501|NCT01115998|182935207|SUPERIORITY_OR_OTHER|||||||0.57||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.57
91494895|NCT02442869|182861341|SUPERIORITY||Net difference in proportion|1.73||||0.19|TWO_SIDED|95.0|-2.41|15.35|||Chi-squared|Df (1)|NNT = 5.59|Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.||15.35|-2.41|0.19
91494896|NCT02442869|182861342|SUPERIORITY||Net difference in proportion|1.3||||0.25|TWO_SIDED||||||Regression, Logistic|||||||0.25
91529502|NCT01115998|182935207|SUPERIORITY_OR_OTHER|||||||0.69||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Personal-social total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.69
91529503|NCT01115998|182935207|SUPERIORITY_OR_OTHER|||||||0.28||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"BID total score~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.28
91529504|NCT01115998|182935208|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
91733260|NCT02546323|183361195|OTHER||Least squares mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.104||0.047|TWO_SIDED|95.0|0.02|4.36|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate|Treatment difference (rosuvastatin 20 mg - placebo): ApoA-I||4.36|0.02|0.047
91733261|NCT02546323|183361195|OTHER||Least squares mean difference|-26.77|STANDARD_ERROR_OF_MEAN|2.041|<|0.001|TWO_SIDED|95.0|-30.78|-22.76|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB/ApoA-I ratio||-22.76|-30.78|<0.001
91733262|NCT02546323|183361196|OTHER||Least squares mean difference|-39.51|STANDARD_ERROR_OF_MEAN|1.819|<|0.001|TWO_SIDED|95.0|-43.08|-35.94|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-35.94|-43.08|<0.001
91733263|NCT02546323|183361196|OTHER||Least squares mean difference|-25.46|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-27.7|-23.23|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-23.23|-27.70|<0.001
91733264|NCT02546323|183361196|OTHER||Least squares mean difference|3.67|STANDARD_ERROR_OF_MEAN|1.051|<|0.001|TWO_SIDED|95.0|1.6|5.73|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||5.73|1.60|<0.001
91494897|NCT02442869|182861343|SUPERIORITY|Power analyses. We determined that with a sample size of 62 clients, the outcome analyses had at least 80% power to detect an effect size of 0.80 (Ahn etal., 2001)|Mean Difference (Net)|0.55||||0.035|TWO_SIDED|95.0|0.04|1.05|||t-test, 2 sided|t(60) = 2.15||||1.05|0.04|0.035
91529505|NCT01115998|182935208|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
91733265|NCT02546323|183361196|OTHER||Least squares mean difference|-18.41|STANDARD_ERROR_OF_MEAN|2.981|<|0.001|TWO_SIDED|95.0|-24.26|-12.55|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.55|-24.26|<0.001
91733266|NCT02546323|183361196|OTHER||Least squares mean difference|-33.78|STANDARD_ERROR_OF_MEAN|1.529|<|0.001|TWO_SIDED|95.0|-36.78|-30.78|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-30.78|-36.78|<0.001
91733267|NCT02546323|183361196|OTHER||Least squares mean difference|-33.93|STANDARD_ERROR_OF_MEAN|1.836|<|0.001|TWO_SIDED|95.0|-37.54|-30.32|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-30.32|-37.54|<0.001
91733268|NCT00863304|183361207|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.65|-0.62||P-value was based on pairwise comparisons.|ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.62|-1.65|<0.001
91494898|NCT03521934|182861344|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.52|0.85|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.85|0.52|< 0.001
91529506|NCT03268590|182935286|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
91529507|NCT03268590|182935287|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
91529508|NCT03268590|182935288|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
91529509|NCT03537261|182935312|SUPERIORITY||Mean Difference (Net)|5.8||||0.11|TWO_SIDED|95.0|-1.4|13.1|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||13.1|-1.4|0.11
91529510|NCT03537261|182935313|SUPERIORITY||Mean Difference (Net)|-2.2||||0.4|TWO_SIDED|95.0|-7.4|3.0|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||3.0|-7.4|0.40
91529511|NCT03537261|182935314|SUPERIORITY||Mean Difference (Net)|0.6||||0.72|TWO_SIDED|95.0|-2.9|4.2|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||4.2|-2.9|0.72
91494899|NCT03521934|182861345|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.49|< 0.001
91494900|NCT03521934|182861346|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.36|TWO_SIDED|95.0|0.58|1.22|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.22|0.58|= 0.36
91529512|NCT00672958|182935456|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74||||0.407|TWO_SIDED|95.0|-2.48|1.01||Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.||Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.||1.01|-2.48|0.407
91529513|NCT00672958|182935457|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.901|TWO_SIDED|95.0|-0.97|1.1|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Comparison of change from Baseline at Week 1.||1.10|-0.97|0.901
91529514|NCT00672958|182935457|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.701|TWO_SIDED|95.0|-1.07|1.59|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 2||1.59|-1.07|0.701
91529515|NCT00672958|182935457|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68||||0.356|TWO_SIDED|95.0|-2.11|0.76|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 3||0.76|-2.11|0.356
91529516|NCT00672958|182935457|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.67|TWO_SIDED|95.0|-1.85|1.19|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 4||1.19|-1.85|0.670
91529517|NCT00672958|182935457|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87||||0.304|TWO_SIDED|95.0|-2.52|0.79|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 5||0.79|-2.52|0.304
91529518|NCT04844918|182935471|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-18.7|-13.5|||Mixed Models Analysis|||||-13.5|-18.7|<0.001
91733269|NCT00863304|183361207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.32|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.32|0.002
91733270|NCT00863304|183361207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.09|TWO_SIDED|95.0|-0.96|0.07||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.96|0.090
91733271|NCT00863304|183361207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.26||0.009|TWO_SIDED|95.0|-1.21|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-1.21|0.009
91733272|NCT00863304|183361207|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.26||0.175|TWO_SIDED|95.0|-0.87|0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.87|0.175
91529519|NCT04844918|182935471|SUPERIORITY||LS Mean Difference|-21.1|||<|0.001|TWO_SIDED|95.0|-23.6|-18.5|||Mixed Models Analysis|||||-18.5|-23.6|<0.001
91529520|NCT04844918|182935472|SUPERIORITY||Odds Ratio (OR)|119.65|||<|0.001|TWO_SIDED|95.0|29.06|492.67|||Mixed Models Analysis|||||492.67|29.06|<0.001
91529521|NCT04844918|182935472|SUPERIORITY||Odds Ratio (OR)|153.57|||<|0.001|TWO_SIDED|95.0|36.03|654.53|||Mixed Models Analysis|||||654.53|36.03|<0.001
91529522|NCT04844918|182935473|SUPERIORITY||Odds Ratio (OR)|24.26|||<|0.001|TWO_SIDED|95.0|8.62|68.28|||Regression, Logistic|||||68.28|8.62|<0.001
91529523|NCT04844918|182935473|SUPERIORITY||Odds Ratio (OR)|38.27|||<|0.001|TWO_SIDED|95.0|13.21|110.89|||Regression, Logistic|||||110.89|13.21|<0.001
91529524|NCT04844918|182935474|SUPERIORITY||LS Mean Difference|-15.0|||<|0.001|TWO_SIDED|95.0|-18.91|-11.09|||Mixed Models Analysis|||||-11.09|-18.91|<0.001
91529525|NCT04844918|182935474|SUPERIORITY||LS Mean Difference|-12.8|||<|0.001|TWO_SIDED|95.0|-16.56|-9.05|||Mixed Models Analysis|||||-9.05|-16.56|<0.001
91529526|NCT04844918|182935475|SUPERIORITY||LS Mean Difference|-55.76|||<|0.001|TWO_SIDED|95.0|-69.74|-41.77|||Mixed Models Analysis|||||-41.77|-69.74|<0.001
91529527|NCT04844918|182935475|SUPERIORITY||LS Mean Difference|-64.82|||<|0.001|TWO_SIDED|95.0|-78.2|-51.43|||Mixed Models Analysis|||||-51.43|-78.20|<0.001
91529528|NCT04844918|182935476|SUPERIORITY||LS Mean Difference|-40.7|||<|0.001|TWO_SIDED|95.0|-50.0|-29.7|||Mixed Models Analysis|||||-29.7|-50.0|<0.001
91529529|NCT04844918|182935476|SUPERIORITY||LS Mean Difference|-44.5|||<|0.001|TWO_SIDED|95.0|-52.7|-34.9|||Mixed Models Analysis|||||-34.9|-52.7|<0.001
91529530|NCT04844918|182935477|SUPERIORITY||LS Mean Difference|-44.4|||<|0.001|TWO_SIDED|95.0|-53.0|-35.7|||ANCOVA|||||-35.7|-53.0|<0.001
91529531|NCT04844918|182935477|SUPERIORITY||LS Mean Difference|-50.4|||<|0.001|TWO_SIDED|95.0|-58.8|-41.9|||ANCOVA|||||-41.9|-58.8|<0.001
91529532|NCT04844918|182935478|SUPERIORITY||Odds Ratio (OR)|25.42|||<|0.001|TWO_SIDED|95.0|7.25|89.14|||Regression, Logistic|||||89.14|7.25|<0.001
91529533|NCT04844918|182935478|SUPERIORITY||Odds Ratio (OR)|70.66|||<|0.001|TWO_SIDED|95.0|12.73|392.24|||Regression, Logistic|||||392.24|12.73|<0.001
91529534|NCT04844918|182935479|SUPERIORITY||Odds Ratio (OR)|9.29|||<|0.001|TWO_SIDED|95.0|2.86|30.2|||Regression, Logistic|||||30.20|2.86|<0.001
91733273|NCT00863304|183361208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.71|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.71|<0.001
91733274|NCT00863304|183361208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.48|-0.51||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.51|-1.48|<0.001
91733275|NCT00863304|183361208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.067|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.067
91494901|NCT03521934|182861347|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.56|0.92||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.92|0.56|
91494902|NCT03521934|182861348|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.86||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.86|0.54|
91529535|NCT04844918|182935479|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|4.78|51.37|||Regression, Logistic|||||51.37|4.78|<0.001
91733276|NCT00863304|183361208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.25||0.002|TWO_SIDED|95.0|-1.26|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.26|0.002
91733277|NCT00863304|183361208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.031|TWO_SIDED|95.0|-1.03|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-1.03|0.031
91733278|NCT00863304|183361209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.50|<0.001
91733279|NCT00863304|183361209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-0.48|<0.001
91733280|NCT00863304|183361209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.078|TWO_SIDED|95.0|-0.3|0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.02|-0.30|0.078
91733281|NCT00863304|183361209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.019
91733282|NCT00863304|183361209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.029
91733283|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
91733284|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
91733285|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
91733286|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
91733287|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
91733288|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.63|<0.001
91733289|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.49|-1.42|<0.001
91494903|NCT03521934|182861349|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.59|1.14||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.14|0.59|
91494904|NCT03521934|182861350|SUPERIORITY||Hazard Ratio (HR)|4.1|||||TWO_SIDED|95.0|1.3|7.0||||||The change from baseline to Month 4 was analyzed using an ANCOVA model with treatment groups as factor and baseline KCCQ-12 score and randomization stratification factors as covariates.||7|1.3|
91733290|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.007|TWO_SIDED|95.0|-1.11|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-1.11|0.007
91733291|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.029|TWO_SIDED|95.0|-0.99|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.99|0.029
91494905|NCT03521934|182861351|SUPERIORITY||Difference in Least Squares Means|-0.16|||||TWO_SIDED|95.0|-1.3|0.98||||||Rate of decline in eGFR observed over time was analyzed by MMRM with absolute change in eGFR from baseline as the outcome, a random effect for intercept, and fixed effects for treatment, baseline value, and time.||0.98|-1.3|
91494906|NCT01391559|182861352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.17||95.0|||||t-test, 2 sided|||||||0.17
91513304|NCT01975389|182898150|SUPERIORITY||LS mean difference|-51.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-52.37|-50.42|||MMRM|||Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.42|-52.37|<0.001
91733292|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.193|TWO_SIDED|95.0|-0.78|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.78|0.193
91733293|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.68|-0.73||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.73|-1.68|<0.001
91733294|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.24||0.001|TWO_SIDED|95.0|-1.28|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.28|0.001
91733295|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.011|TWO_SIDED|95.0|-1.1|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.10|0.011
91733296|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.06|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.06|0.017
91733297|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.24||0.464|TWO_SIDED|95.0|-0.66|0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.30|-0.66|0.464
91733298|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.72|-0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.72|-1.72|<0.001
91494907|NCT00489541|182861385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||t-test, 2 sided|||A superiority test of TAXUX Element vs bare metal (BMS) Express historical control. The null hypothesis that the true difference in means (TAXUS Element - BMS Express) is equal to zero was tested against the two-sided alternative that the true difference in means is different from zero. A sample size of 224 patients in the TAXUS Element group (190 after 15% attrition due to angiographic follow-up) provided 85% power.||-0.30|-0.54|<0.0001
91733299|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.55|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.55|<0.001
91733300|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.26||0.014|TWO_SIDED|95.0|-1.14|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.14|0.014
91494908|NCT00489541|182861386|SUPERIORITY_OR_OTHER||12-month TLR rate|7.34|||<|0.0001|ONE_SIDED|95.0||10.8|||Chi-squared|||One-sided, single-sample binomial test to compare the observed TLF rate in PERSEUS SV to the pre-specified performance goal (19.5%). The normal approximation of the test statistic was used. The null hypothesis that the true TAXUS Element TLF rate is greater than or equal to the performance goal was tested against the one-sided alternative that the true rate is less than the performance goal. A sample size of 224 patients (accounting for 5% attrition to follow-up) provided 80% power.||10.8||<0.0001
91494909|NCT04182763|182861389|SUPERIORITY|||||||0.5|||||||Wald test after neg binomial regression|Chi-squared with 3 d.f.||Mean counts of events per person were calculated from a negative binomial regression model with categorical coefficients for active dose levels, controlling for the baseline number of prescriptions. A joint test of the null hypothesis that the three regression parameters representing active treatment = 0 was done.||||0.50
91494910|NCT04182763|182861394|SUPERIORITY|||||||0.105||||||Two-sided threshold of p\<.10|Linear contrast / test for trend|Contrast after mixed-effects GLM with log link, random subject intercept, treatment, PKAN type, and time (1 mo vs 3d).||Test that high \> med \> low \> placebo vs the null that all groups are equal at 1 month + 3 days after first dose. Adjusted for PKAN type (classical or atypical), because randomization was stratified on type, and time point.||||0.105
91494911|NCT04182763|182861394|SUPERIORITY|||||||0.55||||||Two-sided threshold of p\<.10|Linear contrast / test for trend|Contrast after GLM with log link, treatment, and PKAN type.||Test that high \> med \> low \> placebo vs the null that all groups are equal at 6 months after first dose. PKAN type (classical or atypical) was included because randomization was stratified on type. The study hypothesis was that expression levels would not vary significantly at this time point.||||0.55
91494912|NCT01774604|182861465|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.33
91494913|NCT01774604|182861466|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91494914|NCT01774604|182861467|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91494915|NCT01774604|182861468|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||0.15
91494916|NCT01774604|182861469|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
91494917|NCT01774604|182861470|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
91494918|NCT01774604|182861471|SUPERIORITY_OR_OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
91494919|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.08|||<|0.001|TWO_SIDED|95.0|1.05|1.11||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.|Regression, Cox||The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF|The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.11|1.05|< 0.001
91529536|NCT04844918|182935480|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|9.35|80.88|||Regression, Logistic|||||80.88|9.35|<0.001
91529537|NCT04844918|182935480|SUPERIORITY||Odds Ratio (OR)|40.01|||<|0.001|TWO_SIDED|95.0|13.27|120.57|||Regression, Logistic|||||120.57|13.27|<0.001
91759395|NCT01865448|183411656|SUPERIORITY_OR_OTHER|||||||0.8625|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8625
91494920|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.02|TWO_SIDED|95.0|1.01|1.08||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.|Regression, Cox||The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF|The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.08|1.01|0.02
91529538|NCT04844918|182935481|SUPERIORITY||Odds Ratio (OR)|185.92|||<|0.001|TWO_SIDED|95.0|46.39|745.16|||Regression, Logistic|||||745.16|46.39|<0.001
91529539|NCT04844918|182935481|SUPERIORITY||Odds Ratio (OR)|318.02|||<|0.001|TWO_SIDED|95.0|74.49|1357.79|||Regression, Logistic|||||1357.79|74.49|<0.001
91529540|NCT04844918|182935482|SUPERIORITY||Odds Ratio (OR)|100.21|||<|0.001|TWO_SIDED|95.0|18.64|538.74|||Regression, Logistic|||||538.74|18.64|<0.001
91529541|NCT04844918|182935482|SUPERIORITY||Odds Ratio (OR)|286.73|||<|0.001|TWO_SIDED|95.0|50.68|1622.06|||Regression, Logistic|||||1622.06|50.68|<0.001
91529542|NCT04844918|182935483|SUPERIORITY||LS Mean Difference|-14.5|||<|0.001|TWO_SIDED|95.0|-16.8|-12.2|||Mixed Models Analysis|||||-12.2|-16.8|<0.001
91529543|NCT04844918|182935483|SUPERIORITY||LS Mean Difference|-19.3|||<|0.001|TWO_SIDED|95.0|-21.6|-17.0|||Mixed Models Analysis|||||-17.0|-21.6|<0.001
91529544|NCT04844918|182935484|SUPERIORITY||LS Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.1|-4.4|||Mixed Models Analysis|||||-4.4|-6.1|<0.001
91529545|NCT04844918|182935484|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.0|-6.3|||Mixed Models Analysis|||||-6.3|-8.0|<0.001
91733301|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.26||0.023|TWO_SIDED|95.0|-1.09|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.09|0.023
91733302|NCT00863304|183361210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.26||0.114|TWO_SIDED|95.0|-0.92|0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.10|-0.92|0.114
91529546|NCT04844918|182935485|SUPERIORITY||LS Mean Difference|-36.1|||<|0.001|TWO_SIDED|95.0|-42.9|-29.3|||Mixed Models Analysis|||||-29.3|-42.9|<0.001
91529547|NCT04844918|182935485|SUPERIORITY||LS Mean Difference|-41.1|||<|0.001|TWO_SIDED|95.0|-47.8|-34.4|||Mixed Models Analysis|||||-34.4|-47.8|<0.001
91529548|NCT04844918|182935486|SUPERIORITY||LS Mean Difference|-27.2|||<|0.001|TWO_SIDED|95.0|-32.6|-21.9|||Mixed Models Analysis|||||-21.9|-32.6|<0.001
91529549|NCT04844918|182935486|SUPERIORITY||LS Mean Difference|-31.5|||<|0.001|TWO_SIDED|95.0|-36.7|-26.2|||Mixed Models Analysis|||||-26.2|-36.7|<0.001
91529550|NCT04844918|182935487|SUPERIORITY||LS Mean Difference|-0.1||||0.004|TWO_SIDED|95.0|-0.16|-0.03|||Mixed Models Analysis|||||-0.03|-0.16|0.004
91529551|NCT04844918|182935487|SUPERIORITY||LS Mean Difference|-0.09||||0.006|TWO_SIDED|95.0|-0.15|-0.03|||Mixed Models Analysis|||||-0.03|-0.15|0.006
91529552|NCT04844918|182935488|SUPERIORITY||Odds Ratio (OR)|28.52|||<|0.001|TWO_SIDED|95.0|4.31|188.55|||Regression, Logistic|||||188.55|4.31|<0.001
91529553|NCT04844918|182935488|SUPERIORITY||Odds Ratio (OR)|57.73|||<|0.001|TWO_SIDED|95.0|8.68|383.88|||Regression, Logistic|||||383.88|8.68|<0.001
91529554|NCT04844918|182935489|SUPERIORITY||LS Mean Difference|-11.4|||<|0.001|TWO_SIDED|95.0|-13.8|-9.0|||Mixed Models Analysis|||||-9.0|-13.8|<0.001
91529555|NCT04844918|182935489|SUPERIORITY||LS Mean Difference|-15.3|||<|0.001|TWO_SIDED|95.0|-17.7|-13.0|||Mixed Models Analysis|||||-13.0|-17.7|<0.001
91529556|NCT04844918|182935490|SUPERIORITY||LS Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||Mixed Models Analysis|||||-0.53|-0.77|<0.001
91529557|NCT04844918|182935490|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.77|-0.55|||Mixed Models Analysis|||||-0.55|-0.77|<0.001
91529558|NCT04844918|182935491|SUPERIORITY||LS Mean Difference|-3.91|||||TWO_SIDED|95.0|-5.74|-2.08||||||||-2.08|-5.74|
91529559|NCT04844918|182935491|SUPERIORITY||LS Mean Difference|-4.55|||||TWO_SIDED|95.0|-6.29|-2.81||||||||-2.81|-6.29|
91529560|NCT04844918|182935492|SUPERIORITY||LS Mean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-17.0|-9.3|||Mixed Models Analysis|||||-9.3|-17.0|<0.001
91529561|NCT04844918|182935492|SUPERIORITY||LS Mean Difference|-13.9|||<|0.001|TWO_SIDED|95.0|-17.7|-10.1|||Mixed Models Analysis|||||-10.1|-17.7|<0.001
91529562|NCT04844918|182935493|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.3|-3.4|||Mixed Models Analysis|||||-3.4|-9.3|<0.001
91529563|NCT04844918|182935493|SUPERIORITY||LS Mean Difference|-6.8|||<|0.001|TWO_SIDED|95.0|-9.7|-3.9|||Mixed Models Analysis|||||-3.9|-9.7|<0.001
91529564|NCT04844918|182935494|SUPERIORITY||LS Mean Difference|1.3||||0.022|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||||2.3|0.2|0.022
91529565|NCT04844918|182935494|SUPERIORITY||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.2|||ANCOVA|||||3.2|1.1|<0.001
91529566|NCT04844918|182935495|SUPERIORITY||LS Mean Difference|13.0|||<|0.001|TWO_SIDED|95.0|7.4|18.7|||ANCOVA|||||18.7|7.4|<0.001
91529567|NCT04844918|182935495|SUPERIORITY||LS Mean Difference|10.8|||<|0.001|TWO_SIDED|95.0|5.4|16.3|||ANCOVA|||||16.3|5.4|<0.001
91529568|NCT04844918|182935496|SUPERIORITY||LS Mean Difference|0.03||||0.099|TWO_SIDED|95.0|0.0|0.06|||ANCOVA|||||0.06|0.00|0.099
91529569|NCT04844918|182935496|SUPERIORITY||LS Mean Difference|0.02||||0.236|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA|||||0.05|-0.01|0.236
91529570|NCT01009047|182935497|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.83||0.935|TWO_SIDED|95.0|-3.46|3.76||Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.76|-3.46|0.935
91529571|NCT01009047|182935498|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.2||0.877|TWO_SIDED|95.0|-4.68|4.0||Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||4.00|-4.68|0.877
91759396|NCT01865448|183411656|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0068
91494921|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.56|TWO_SIDED|95.0|0.77|1.61||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of being male on a patient's risk of developing AF.|The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).||1.61|0.77|0.56
91494922|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.66|TWO_SIDED|95.0|0.74|1.59||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.|The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.59|0.74|0.66
91529572|NCT01009047|182935499|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.341|TWO_SIDED|95.0|-0.55|1.59||Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.59|-0.55|0.341
91733303|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
91733304|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
91733305|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
91733306|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
91733307|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
91733308|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.59|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.59|<0.001
91733309|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.37|-0.45||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.45|-1.37|<0.001
91733310|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.012|TWO_SIDED|95.0|-1.05|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.05|0.012
91733311|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.0|-0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.07|-1.00|0.023
91529573|NCT01009047|182935499|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.723|TWO_SIDED|95.0|-1.06|1.53||Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.53|-1.06|0.723
91529574|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.351||||||Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.351
91529575|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.691||||||Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.691
91529576|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.965||||||Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.965
91733312|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.175|TWO_SIDED|95.0|-0.78|0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.14|-0.78|0.175
91733313|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.55|<0.001
91759397|NCT01865448|183411657|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3694
91759398|NCT01865448|183411657|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0291
91759399|NCT01865448|183411657|SUPERIORITY_OR_OTHER|||||||0.0402|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0402
91759400|NCT01865448|183411658|SUPERIORITY_OR_OTHER|||||||0.1226|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1226
91759401|NCT01865448|183411658|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0472
91759402|NCT01865448|183411658|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0197
91494923|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.73|TWO_SIDED|95.0|0.69|1.69||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.|The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.69|0.69|0.73
91733314|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.41||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.41|-1.34|<0.001
91733315|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.03|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.03|0.017
91733316|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.027|TWO_SIDED|95.0|-0.99|-0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.06|-0.99|0.027
91733317|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.19|TWO_SIDED|95.0|-0.78|0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.15|-0.78|0.190
91733318|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.68||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.68|-1.63|<0.001
91733319|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.6||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.60|-1.55|<0.001
91733320|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.034|TWO_SIDED|95.0|-0.99|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.99|0.034
91733321|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|9.0|-1.12|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.12|0.009
91733322|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.04|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.04|0.023
91733323|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.64||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.64|-1.60|<0.001
91494924|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.58|2.6||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.|The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||2.60|0.58|0.58
91529577|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.766||||||Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.766
91733324|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.35|<0.001
91529578|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.984||||||Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.984
91733325|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.25||0.092|TWO_SIDED|95.0|-0.9|0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.90|0.092
91733326|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.19|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.19|0.004
91733327|NCT00863304|183361211|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.064|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.064
91494925|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.64|1.32||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.|The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.32|0.64|0.65
91494926|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.22|TWO_SIDED|95.0|0.45|1.2||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.|The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.20|0.45|0.22
91494927|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.53|TWO_SIDED|95.0|0.54|1.38||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.|The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.38|0.54|0.53
91733328|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
91733329|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
91733330|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
91733331|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
91733332|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
91733333|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.74|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.74|<0.001
91494928|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.21|TWO_SIDED|95.0|0.53|1.15||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.|The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.15|0.53|0.21
91733334|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.58|-0.66||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.66|-1.58|<0.001
91733335|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.19|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.19|0.002
91733336|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.019|TWO_SIDED|95.0|-1.01|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-1.01|0.019
91733337|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
91513305|NCT01975389|182898150|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.33|7.5|||MMRM|||HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||7.50|6.33|<0.001
91513306|NCT01975389|182898150|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|3.9|4.9|||MMRM|||Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||4.90|3.90|<0.001
91733338|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.7|-0.78||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.78|-1.70|<0.001
91733339|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.47|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.47|<0.001
91733340|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.009
91733341|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.008
91733342|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
91733343|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.79|<0.001
91733344|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.63|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.63|<0.001
91733345|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.21|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.21|0.003
91733346|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.08|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.08|0.016
91733347|NCT00863304|183361212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.25||0.082|TWO_SIDED|95.0|-0.91|0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.06|-0.91|0.082
91733348|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
91733349|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
91733350|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
91733351|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
91733352|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
91733353|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.73|-0.82||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.82|-1.73|<0.001
91733354|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.61|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.61|<0.001
91733355|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.16|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.16|0.003
91733356|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.03|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.03|0.015
91733357|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.053|TWO_SIDED|95.0|-0.91|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.91|0.053
91733358|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.66|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.66|<0.001
91733359|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.56|-0.65||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.65|-1.56|<0.001
91759403|NCT01865448|183411659|SUPERIORITY_OR_OTHER|||||||0.8969|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8969
91494929|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.19|TWO_SIDED|95.0|0.45|1.17||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.|The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.17|0.45|0.19
91494930|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|1.97||||0.16|TWO_SIDED|95.0|0.76|5.14||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.|The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||5.14|0.76|0.16
91494931|NCT01727297|182861473|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.63|TWO_SIDED|95.0|0.56|1.43||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.|The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.43|0.56|0.63
91494932|NCT01192516|182861477|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, pain level, and body mass index at baseline.||||||.85
91494933|NCT01192516|182861480|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, and body mass index.||||||.06
91494934|NCT01192516|182861483|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Adjusted for age, gender, body mass index, and pain at baseline.|Mixed Models Analysis|||||||.36
91494935|NCT01217801|182861517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|93.77||||0.05|TWO_SIDED|90.0|89.15|98.63|||Regression, Linear|||Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CI||98.63|89.15|0.05
91494936|NCT00291577|182861558|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.89||||||90.0|80.34|121.73|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3. Due to the exploratory nature of the study, no statistical hypothesis testing was done since the primary purpose was to assess the tolerability of the combination of SU011248 with docetaxel.||121.73|80.34|
91494937|NCT00291577|182861558|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.96||||||90.0|59.76|112.41|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||112.41|59.76|
91494938|NCT00291577|182861558|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|97.81||||||90.0|80.44|118.94|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||118.94|80.44|
91494939|NCT00291577|182861559|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.23||||||90.0|82.75|123.83|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3||123.83|82.75|
91494940|NCT00291577|182861559|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.72||||||90.0|62.4|107.04|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||107.04|62.40|
91494941|NCT00291577|182861559|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.0||||||90.0|82.95|120.56|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||120.56|82.95|
91494942|NCT00291577|182861563|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|99.18||||||90.0|78.73|124.95|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||124.95|78.73|
91494943|NCT00291577|182861564|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.98||||||90.0|78.73|114.58|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.58|78.73|
91494944|NCT00291577|182861566|SUPERIORITY_OR_OTHER||rate (percent)|73.7||||||95.0|48.8|90.9|||||Two-sided Confidence Interval (CI) (%) from exact method based on F distribution.|Overall confirmed objective response rate (CR + PR)||90.9|48.8|
91494945|NCT00291577|182861567|SUPERIORITY_OR_OTHER||rate (percent)|89.5||||||95.0|66.9|98.7|||||Two-sided CI (%) from exact method based on F distribution.|Clinical Benefit Rate (CR + PR + SD \> = 24 weeks)||98.7|66.9|
91494946|NCT00291577|182861569|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.57||||||90.0|79.9|114.32|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.32|79.90|
91494947|NCT00291577|182861570|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|112.39||||||90.0|81.05|155.85|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||155.85|81.05|
91494948|NCT00291577|182861571|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.79||||||90.0|79.82|114.96|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.96|79.82|
91494949|NCT03473977|182861578|OTHER|||||||0.0001|||||||Fisher Exact|||||||0.0001
91494950|NCT03473977|182861579|OTHER|||||||0.75|||||||Kruskal-Wallis|||||||0.75
91494951|NCT03473977|182861580|OTHER|||||||0.006|||||||Kruskal-Wallis|||||||0.006
91494952|NCT03473977|182861581|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91494953|NCT03473977|182861582|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
91494954|NCT03473977|182861583|OTHER|||||||0.014|||||||Kruskal-Wallis|||||||0.014
91494955|NCT03473977|182861584|OTHER|||||||0.78|||||||Kruskal-Wallis|||Pain Score Comparison||||0.78
91494956|NCT03473977|182861584|OTHER|||||||0.34|||||||Kruskal-Wallis|||Non-pain score comparison||||0.34
91494957|NCT03473977|182861584|OTHER|||||||0.66|||||||Kruskal-Wallis|||Satisfaction score comparison||||0.66
91513307|NCT01975389|182898150|SUPERIORITY||LS mean difference|-37.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-38.75|-37.22|||MMRM|||Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-37.22|-38.75|<0.001
91494958|NCT00545662|182861585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.83|1.14||a priori threshold for statistical significance is 0.05|Regression, Logistic|Logistic regression estimated global OR. GEE accounted for correlations of the scales. Models adjusted for site \& injury severity.|The odds in the citicoline group were compared to the odds in the placebo group.|"Null hypothesis: The placebo and citicoline groups do not differ at 90-days on the Core Battery~Power:~1. Two sided type I error of 0.05~2. 85% power~3. Expected OR=1.40 for the global statistic~4. Response rate in the control group~5. Correlations among the nine measures were accounted for. Response rates for the whole sample were a weighted average of the rates provided by TBI severity.~1240 participants were required to detect an OR \>= 1.4 for the global statistic."||1.14|0.83|0.76
91733360|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.23||0.009|TWO_SIDED|95.0|-1.07|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.07|0.009
91733361|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.011|TWO_SIDED|95.0|-1.05|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.05|0.011
91733362|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.035|TWO_SIDED|95.0|-0.95|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.95|0.035
91733363|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.85||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.85|-1.79|<0.001
91733364|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.71|-0.76||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.76|-1.71|<0.001
91733365|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.008
91733366|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.005|TWO_SIDED|95.0|-1.16|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-1.16|0.005
91733367|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.013|TWO_SIDED|95.0|-1.07|-0.12||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.12|-1.07|0.013
91733368|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.76|-0.81||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.81|-1.76|<0.001
91733369|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.58|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.58|<0.001
91733370|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|-0.95|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.00|-0.95|0.050
91733371|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.29|-0.34||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.34|-1.29|<0.001
91733372|NCT00863304|183361213|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.009
91733373|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
91759404|NCT01865448|183411659|SUPERIORITY_OR_OTHER|||||||0.7218|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7218
91759405|NCT01865448|183411659|SUPERIORITY_OR_OTHER|||||||0.4536|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4536
91494959|NCT03845985|182861586|SUPERIORITY|||||||0.838||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.838
91494960|NCT03845985|182861587|SUPERIORITY|||||||0.62||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.620
91759406|NCT01865448|183411660|SUPERIORITY_OR_OTHER|||||||0.8765|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8765
91759407|NCT01865448|183411660|SUPERIORITY_OR_OTHER|||||||0.5114|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5114
91759408|NCT01865448|183411660|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0237
91759409|NCT01865448|183411661|SUPERIORITY_OR_OTHER|||||||0.2914|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2914
91759410|NCT01865448|183411661|SUPERIORITY_OR_OTHER|||||||0.5594|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5594
91494961|NCT03845985|182861588|SUPERIORITY|||||||0.713||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.713
91529579|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.985||||||Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.985
91494962|NCT03845985|182861589|SUPERIORITY|||||||0.509||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.509
91494963|NCT03845985|182861590|SUPERIORITY|||||||0.491||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.491
91529580|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.803||||||Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.803
91529581|NCT01009047|182935500|SUPERIORITY_OR_OTHER|||||||0.745||||||Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.745
91529582|NCT01009047|182935502|SUPERIORITY_OR_OTHER|||||||0.296||||||Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.|Cochran-Mantel-Haenszel|||||||0.296
91529583|NCT01009047|182935503|SUPERIORITY_OR_OTHER|||||||0.843||||||Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.843
91529584|NCT01009047|182935503|SUPERIORITY_OR_OTHER|||||||0.914||||||Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.914
91529585|NCT01009047|182935504|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.27||0.895|TWO_SIDED|95.0|-2.34|2.67||Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||2.67|-2.34|0.895
91529586|NCT01009047|182935504|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.66||0.705|TWO_SIDED|95.0|-2.64|3.89||Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.89|-2.64|0.705
91529587|NCT01009047|182935505|SUPERIORITY_OR_OTHER|||||||0.119||||||Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.119
91494964|NCT03845985|182861591|SUPERIORITY|||||||0.715||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.715
91494965|NCT03845985|182861592|SUPERIORITY|||||||0.665||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.665
91494966|NCT03845985|182861593|SUPERIORITY|||||||0.875||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.875
91494967|NCT03845985|182861594|SUPERIORITY|||||||0.61||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Risk and Aggression/Liquid Courage/Sociability Subscale||||.610
91529588|NCT01009047|182935505|SUPERIORITY_OR_OTHER|||||||0.444||||||Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.444
91529589|NCT02731313|182935506|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): kappa coefficient = 0.90||||||0.7436|||||||Kappa-test p-value, 2 sided|||Rationale for the determination of the number of samples:The following hypotheses were considered: two-sided risk alpha = 5%, power (1 - beta) = 90%, a success rate (rate of positive HER-2 status) = 17%, null hypothesis (H0): kappa coefficient = 0.90. 359 samples would allow determining a first estimate of the 0.90 coefficient of correlation kappa. The total number of samples, which had to be included in this study was 395, considering a 10% rate of non-evaluable samples.||||0.7436
91529590|NCT01558674|182935524|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-98.5|||||TWO_SIDED|95.0|-138.0|-59.1|||Linear mixed effect model||8-mg MK-7145 LS Mean minus Furosemide LS Mean|||-59.1|-138.0|
91529591|NCT01558674|182935526|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|1.1|||||TWO_SIDED|90.0|0.99|1.22|||Mixed Linear Effects Model||GMR = Geometric mean (GM) MK-7145 8 mg divided by GM Furosemide|||1.22|0.99|
91529592|NCT00614198|182935553|SUPERIORITY_OR_OTHER||||||<|0.01||||||A priori p threshold set for stage 1 (baseline - 8m; p\<0.01) or (baseline - 12 months, p\<0.05) in order to progress to stage 2 (8 or 12 months - 20 or 24 months).|Mixed Models Analysis|||1st stage analysis (baseline-8m or 12m) used a repeated measures model for all assessment measures. Model included baseline, age, time and time\*treatment interaction. Results informed 2nd stage (8 or 12 months - 20 or 24 months). 2nd stage analysis based on various statistical scenarios (baseline vs 12 months on intervention, 12 months of no intervention vs 12 on intervention, baseline vs 24 months on intervention). No ADOS assessments were used at 12 months because of risk of practice effects.||||<0.01
91529593|NCT01225835|182935555|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.003
91529594|NCT01225835|182935555|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \< 39 years||||0.015
91529595|NCT01225835|182935555|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \>= 39 years||||0.027
91529596|NCT01225835|182935557|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05.|Fisher Exact|||||||1.00
91529597|NCT01225835|182935558|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.004
91529598|NCT01225835|182935559|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.121
91529599|NCT01225835|182935560|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Level of significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91529600|NCT01225835|182935561|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
91529601|NCT01225835|182935563|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.482
91529602|NCT01225835|182935564|SUPERIORITY_OR_OTHER|||||||0.871||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Chi-squared|||||||0.871
91494968|NCT03845985|182861594|SUPERIORITY|||||||0.658||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Self-Perception/Cognitive and Behavioral Impairment Subscale||||.658
91529603|NCT01225835|182935565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
91733374|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
91733375|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
91733376|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
91733377|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
91733378|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.56|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.56|<0.001
91494969|NCT03845985|182861594|SUPERIORITY|||||||1||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Sexuality Subscale||||1.000
91494970|NCT03845985|182861594|SUPERIORITY|||||||0.007||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Tension Reduction Subscale||||.007
91733379|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.58|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.58|<0.001
91733380|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|<0.001
91733381|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.102
91733382|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.066|TWO_SIDED|95.0|-0.31|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.31|0.066
91759411|NCT01865448|183411661|SUPERIORITY_OR_OTHER|||||||0.2532|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2532
91494971|NCT03845985|182861595|SUPERIORITY|||||||0.407||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.407
91494972|NCT03845985|182861596|SUPERIORITY|||||||0.893||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.893
91494973|NCT03845985|182861597|SUPERIORITY|||||||0.709||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.709
91759412|NCT01865448|183411662|SUPERIORITY_OR_OTHER|||||||0.0528|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0528
91759413|NCT01865448|183411662|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1920
91759414|NCT01865448|183411662|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0011
91494974|NCT03926169|182861600|SUPERIORITY||Adjusted Response Rate Difference (%)|6.0||||0.422|TWO_SIDED|97.5|-10.8|22.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||22.8|-10.8|0.422
91494975|NCT03926169|182861600|SUPERIORITY||Adjusted Response Rate Difference (%)|1.3||||0.858|TWO_SIDED|97.5|-15.4|18.1||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||18.1|-15.4|0.858
91529604|NCT01225835|182935566|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.620
91529605|NCT01225835|182935567|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.478
91529606|NCT01225835|182935568|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||0.69
91759415|NCT01865448|183411663|SUPERIORITY_OR_OTHER|||||||0.2999|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2999
91759416|NCT01865448|183411663|SUPERIORITY_OR_OTHER|||||||0.5184|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5184
91759417|NCT01865448|183411663|SUPERIORITY_OR_OTHER|||||||0.0564|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0564
91759418|NCT01865448|183411664|SUPERIORITY_OR_OTHER|||||||0.0783|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0783
91759419|NCT01865448|183411664|SUPERIORITY_OR_OTHER|||||||0.1263|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1263
91529607|NCT01225835|182935569|SUPERIORITY_OR_OTHER|||||||0.295||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.295
91494976|NCT03926169|182861601|SUPERIORITY||Adjusted Response Rate Difference (%)|-3.0||||0.725|TWO_SIDED|97.5|-21.8|15.9||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||15.9|-21.8|0.725
91494977|NCT03926169|182861601|SUPERIORITY||Adjusted Response Rate Difference (%)|8.8||||0.301|TWO_SIDED|97.5|-10.3|27.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||27.8|-10.3|0.301
91494978|NCT03926169|182861602|SUPERIORITY||Adjusted Response Rate Difference (%)|3.7||||0.65|TWO_SIDED|97.5|-14.5|21.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||21.8|-14.5|0.650
91529608|NCT01225835|182935570|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.405
91529609|NCT01225835|182935571|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||1.000
91529610|NCT02559609|182935623|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1||||.028
91529611|NCT02559609|182935624|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1)||||.027
91529612|NCT02559609|182935625|SUPERIORITY|||||||0.66|||||||ANOVA|df = 1||Group A/B (contrast -1) was compared to Group C/D (contrast 1) to test Aim 2.||||.66
91529613|NCT02559609|182935626|SUPERIORITY|||||||0.89|||||||Regression, Cox|||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.89
91733383|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.28||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.28|-0.60|<0.001
91733384|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-0.53|<0.001
91733385|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.027
91733386|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.42|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-0.42|0.001
91733387|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.020
91733388|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-0.49|<0.001
91733389|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|0.001
91529614|NCT02559609|182935627|SUPERIORITY|||||||0.58|||||||ANOVA|df = 1||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.58
91733390|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.328|TWO_SIDED|95.0|-0.24|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.24|0.328
91733391|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.41|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-0.41|0.002
91733392|NCT00863304|183361214|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.022
91733393|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
91529615|NCT02559609|182935628|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1.||||.024
91529616|NCT00383240|182935640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91733394|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
91733395|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
91733396|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
91733397|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
91494979|NCT03926169|182861602|SUPERIORITY||Adjusted Response Rate Difference (%)|12.3||||0.147|TWO_SIDED|97.5|-6.7|31.3||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||31.3|-6.7|0.147
91494980|NCT03926169|182861603|SUPERIORITY||Adjusted Response Rate Difference (%)|-6.5||||0.342|TWO_SIDED|97.5|-21.8|8.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||8.8|-21.8|0.342
91494981|NCT03926169|182861603|SUPERIORITY||Adjusted Response Rate Difference (%)|-10.6||||0.108|TWO_SIDED|97.5|-25.3|4.2||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||4.2|-25.3|0.108
91529617|NCT00383240|182935640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529618|NCT00383240|182935640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529619|NCT00383240|182935640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491||95.0||||P-Value for Endpoint|ANCOVA|||||||0.491
91529620|NCT00383240|182935640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||P-Value for Endpoint|ANCOVA|||||||0.055
91733398|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.57|<0.001
91733399|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
91733400|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-0.45|<0.001
91733401|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.12|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.120
91733402|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.29|0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.04|-0.29|0.126
91733403|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.30|-0.62|<0.001
91733404|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
91733405|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
91733406|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.009|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.38|0.009
91733407|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|-0.32|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.32|0.052
91733408|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
91733409|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.15|-0.48|<0.001
91733410|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.051|TWO_SIDED|95.0|-0.33|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.33|0.051
91529621|NCT00383240|182935640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||P-Value for Endpoint|ANCOVA|||||||0.008
91529622|NCT00383240|182935641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-Value for Endpoint|ANCOVA|||||||0.174
91529623|NCT00383240|182935641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529624|NCT00383240|182935641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529625|NCT00383240|182935641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529626|NCT00383240|182935641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529627|NCT00383240|182935641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||P-Value for Endpoint|ANCOVA|||||||0.521
91529628|NCT00383240|182935643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||P-Value for Endpoint|ANCOVA|||||||0.026
91733411|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
91733412|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.069|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.069
91733413|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.57|<0.001
91733414|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.20|-0.53|<0.001
91733415|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.37|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.37|0.012
91733416|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.36|0.020
91494982|NCT03926169|182861604|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.97||0.179|TWO_SIDED|97.5|-3.5|0.9||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.9|-3.5|0.179
91494983|NCT03926169|182861604|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.98||0.105|TWO_SIDED|97.5|-3.8|0.6||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.6|-3.8|0.105
91494984|NCT03926169|182861605|SUPERIORITY||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.3385||0.727|TWO_SIDED|97.5|-0.646|0.883||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.883|-0.646|0.727
91733417|NCT00863304|183361215|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.064|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.064
91733418|NCT03898180|183361269|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4107|TWO_SIDED|95.0|0.72|1.14||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, programmed cell death ligand 1 (PD-L1) CPS, and ECOG performance status (PS).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.14|0.72|0.4107
91733419|NCT03898180|183361270|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3505|TWO_SIDED|95.0|0.87|1.48||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.48|0.87|0.3505
91733420|NCT03898180|183361271|SUPERIORITY||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-4.0|12.2|||||Based on Miettinen \& Nurminen method stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||12.2|-4.0|
91733421|NCT03898180|183361274|OTHER||Difference in least squares means|-3.07||||0.182|TWO_SIDED|95.0|-7.57|1.44||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|cLDA model||Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.44|-7.57|0.182
91759420|NCT01865448|183411664|SUPERIORITY_OR_OTHER|||||||0.6484|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.6484
91759421|NCT01865448|183411665|SUPERIORITY_OR_OTHER|||||||0.6896|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6896
91759422|NCT01865448|183411665|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0980
91529629|NCT00383240|182935643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529630|NCT00383240|182935643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529631|NCT00383240|182935643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91759423|NCT01865448|183411665|SUPERIORITY_OR_OTHER|||||||0.3526|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3526
91759424|NCT01865448|183411666|SUPERIORITY_OR_OTHER|||||||0.9662|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9662
91759425|NCT01865448|183411666|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1450
91529632|NCT00383240|182935643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529633|NCT00383240|182935643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||95.0||||P-Value for Endpoint|ANCOVA|||||||0.738
91759426|NCT01865448|183411666|SUPERIORITY_OR_OTHER|||||||0.3811|TWO_SIDED||||||Paired t-test|||||||0.3811
91759427|NCT01865448|183411667|SUPERIORITY_OR_OTHER|||||||0.2643|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2643
91759428|NCT01865448|183411667|SUPERIORITY_OR_OTHER|||||||0.0761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0761
91759429|NCT01865448|183411667|SUPERIORITY_OR_OTHER|||||||0.1342|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.1342
91494985|NCT03926169|182861605|SUPERIORITY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.3273||0.963|TWO_SIDED|97.5|-0.755|0.724||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.724|-0.755|0.963
91494986|NCT03926169|182861606|SUPERIORITY||LS Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.2941||0.886|TWO_SIDED|97.5|-0.622|0.706||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.706|-0.622|0.886
91494987|NCT03926169|182861606|SUPERIORITY||LS Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.2851||0.409|TWO_SIDED|97.5|-0.408|0.879||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.879|-0.408|0.409
91529634|NCT00383240|182935644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0||||P-Value for endpoint|ANCOVA|||||||0.063
91494988|NCT03926169|182861607|SUPERIORITY||LS Mean Difference|-0.252|STANDARD_ERROR_OF_MEAN|0.3212||0.434|TWO_SIDED|97.5|-0.977|0.473||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.473|-0.977|0.434
91494989|NCT03926169|182861607|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.3123||0.813|TWO_SIDED|97.5|-0.779|0.631||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.631|-0.779|0.813
91529635|NCT00383240|182935644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529636|NCT00383240|182935644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529637|NCT00383240|182935644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
91529638|NCT00383240|182935644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-Value for Endpoint|ANCOVA|||||||0.003
91529639|NCT00383240|182935644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.601||95.0||||P-Value for Endpoint|ANCOVA|||||||0.601
91529640|NCT02049710|182935646|OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|95.0|3.0|15.0||||||Summation scores are reported across 3 items measured on a 5-point scale from 1(not at all sure)to5(very sure), which loaded together on a principal components analysis of the baseline data.The summation score thus represents a theoretical range from 3 to 15.The 3 items were as follows:Indicate How Sure You are that You Would be Able to Perform Each of the Following:a)Get the money needed to buy condoms b)Walk into a store\&buy condoms c)Find a place to get condoms for free(Cronbach alpha-0.72)||15|3|
91529641|NCT01216293|182935653|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.2|||||TWO_SIDED|95.0|7.0|30.2|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.2|7.0|
91529642|NCT01216293|182935653|SUPERIORITY_OR_OTHER_LEGACY||Difference|18.2|||||TWO_SIDED|95.0|6.7|30.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.4|6.7|
91529643|NCT01216293|182935654|SUPERIORITY_OR_OTHER_LEGACY||Difference|27.366|||||TWO_SIDED|95.0|12.749|42.957|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||42.957|12.749|
91529644|NCT01216293|182935654|SUPERIORITY_OR_OTHER_LEGACY||Difference|22.025|||||TWO_SIDED|95.0|8.357|35.714|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||35.714|8.357|
91529645|NCT01216293|182935655|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.1|||||TWO_SIDED|95.0|4.0|34.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||34.4|4.0|
91529646|NCT01216293|182935655|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.6|||||TWO_SIDED|95.0|-2.7|28.3|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||28.3|-2.7|
91529647|NCT01216293|182935656|SUPERIORITY_OR_OTHER_LEGACY||Difference|6.83|||||TWO_SIDED|95.0|0.4|12.78|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.78|0.40|
91529648|NCT01216293|182935656|SUPERIORITY_OR_OTHER_LEGACY||Difference|7.23|||||TWO_SIDED|95.0|0.59|12.86|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.86|0.59|
91529649|NCT02555371|182935715|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.004|TWO_SIDED|95.0|0.45|0.86|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.86|0.45|0.004
91529650|NCT02555371|182935716|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.|||0.24|0.15|<0.001
91529651|NCT02555371|182935716|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.12|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.|||0.20|0.12|<0.001
91529652|NCT02555371|182935716|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.|||0.24|0.15|<0.001
91529653|NCT02555371|182935716|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.13|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.|||0.20|0.13|<0.001
91529654|NCT02555371|182935717|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.88|0.49|0.005
91529655|NCT02555371|182935718|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.57|TWO_SIDED|95.0|0.5|3.51|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||3.51|0.50|0.570
91759430|NCT01865448|183411668|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1410
91494990|NCT04974697|182861635|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for myope.|Least-square Mean|58.1|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|50.9|65.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 22 subjects were required to test superiority for myope.||65.4|50.9|
91733422|NCT03898180|183361275|OTHER||Hazard Ratio (HR)|1.64||||0.0005|TWO_SIDED|95.0|1.24|2.16||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||2.16|1.24|0.0005
91733423|NCT01472185|183361298|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.36||P-value is from a mixed effects model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.36|-0.76|< 0.0001
91733424|NCT02958865|183361303|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.69||0.0017|TWO_SIDED|90.0|-3.17|-0.89|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-0.89|-3.17|0.0017
91733425|NCT02958865|183361303|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-5.01|-2.74|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.74|-5.01|< 0.0001
91733426|NCT02958865|183361303|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|90.0|-5.76|-3.46|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-3.46|-5.76|< 0.0001
91733427|NCT02958865|183361303|SUPERIORITY||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.68||0.0045|TWO_SIDED|90.0|-2.92|-0.67|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.||-0.67|-2.92|0.0045
91733428|NCT02958865|183361303|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.69||0.0005|TWO_SIDED|90.0|-3.41|-1.14|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-1.14|-3.41|0.0005
91733429|NCT02958865|183361303|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-4.34|-2.08|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.08|-4.34|< 0.0001
91733430|NCT02958865|183361320|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.0626|TWO_SIDED|90.0|-1.0|19.5|||Chan and Zhang method|||||19.5|-1.0|0.0626
91733431|NCT02958865|183361320|SUPERIORITY||Mean Difference (Final Values)|28.6||||0.0027|TWO_SIDED|90.0|13.9|41.0|||Chan and Zhang method|||||41.0|13.9|0.0027
91733432|NCT02958865|183361320|SUPERIORITY||Mean Difference (Final Values)|34.0||||0.001|TWO_SIDED|90.0|20.2|46.5|||Chan and Zhang Method|||||46.5|20.2|0.0010
91733433|NCT02958865|183361320|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0774|TWO_SIDED|90.0|-4.0|18.1|||Chan and Zhang method|||||18.1|-4.0|0.0774
91733434|NCT02958865|183361320|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
91733435|NCT02958865|183361320|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
91733436|NCT02958865|183361321|SUPERIORITY||Mean Difference (Final Values)|21.6||||0.0111|TWO_SIDED|90.0|5.6|33.2|||Chan and Zhang method|||||33.2|5.6|0.0111
91733437|NCT02958865|183361321|SUPERIORITY||Mean Difference (Final Values)|34.7||||0.0006|TWO_SIDED|90.0|20.2|47.4|||Chan and Zhang method|||||47.4|20.2|0.0006
91733438|NCT02958865|183361321|SUPERIORITY||Mean Difference (Final Values)|42.0||||0.0001|TWO_SIDED|90.0|29.5|54.6|||Chan and Zhang Method|||||54.6|29.5|0.0001
91529656|NCT03615482|182935756|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-0.9||||0.617|TWO_SIDED|95.0|-4.5|2.7|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Erythema||2.7|-4.5|0.617
91733439|NCT02958865|183361321|SUPERIORITY||Mean Difference (Final Values)|20.8||||0.0101|TWO_SIDED|90.0|5.6|33.0|||Chan and Zhang method|||||33.0|5.6|0.0101
91733440|NCT02958865|183361321|SUPERIORITY||Mean Difference (Final Values)|31.9||||0.0014|TWO_SIDED|90.0|17.0|44.8|||Chan and Zhang method|||||44.8|17.0|0.0014
91733441|NCT02958865|183361321|SUPERIORITY||Mean Difference (Final Values)|29.8||||0.0015|TWO_SIDED|90.0|17.0|42.6|||Chan and Zhang method|||||42.6|17.0|0.0015
91733442|NCT02958865|183361322|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.0788|TWO_SIDED|90.0|-3.4|34.4|||Chan and Zhang method|||||34.4|-3.4|0.0788
91733443|NCT02958865|183361322|SUPERIORITY||Mean Difference (Final Values)|45.4||||0.0002|TWO_SIDED|90.0|23.6|62.1|||Chan and Zhang method|||||62.1|23.6|0.0002
91494991|NCT04974697|182861635|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points for hyperope.|Least-square Mean|55.0|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|47.2|62.8|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 18 subjects were required to test superiority for hyperope.||62.8|47.2|
91494992|NCT04974697|182861636|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold 0.00 logMAR for Distance.|Least-square Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.167|-0.091|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 42 subjects were required to test superiority for distance (4m).||-0.091|-0.167|
91494993|NCT04974697|182861636|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate.|Least-square Mean|-0.046|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.084|-0.008|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 7 subjects were required to test superiority for intermediate (64 cm).||-0.008|-0.084|
91494994|NCT04974697|182861636|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near.|Least-square Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|0.029|0.105|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 36 subjects were required to test superiority for near (40 cm).||0.105|0.029|
91494995|NCT04974697|182861637|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|8.4|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|3.1|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|3.1|
91494996|NCT04974697|182861637|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|5.0|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-1.2|11.2|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.2|-1.2|
91529657|NCT03615482|182935756|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.6||||0.32|TWO_SIDED|95.0|-7.8|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Pain||2.6|-7.8|0.320
91494997|NCT04974697|182861638|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|6.9|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|0.0|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|0.0|
91494998|NCT04974697|182861638|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|3.3|STANDARD_ERROR_OF_MEAN|4.03|||TWO_SIDED|95.0|-4.7|11.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.3|-4.7|
91529658|NCT03615482|182935756|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.1||||0.31|TWO_SIDED|95.0|-6.2|2.0|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Swelling||2.0|-6.2|0.310
91529659|NCT03615482|182935757|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.205|TWO_SIDED|95.0|-5.8|1.2|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Arthralgia||1.2|-5.8|0.205
91529660|NCT03615482|182935757|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.9||||0.273|TWO_SIDED|95.0|-8.0|2.3|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Fatigue||2.3|-8.0|0.273
91529661|NCT03615482|182935757|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.372|TWO_SIDED|95.0|-6.9|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Headache||2.6|-6.9|0.372
91494999|NCT04974697|182861639|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|11.2|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|5.0|17.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.4|5.0|
91529662|NCT03615482|182935757|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|2.4||||0.329|TWO_SIDED|95.0|-2.4|7.1|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Myalgia||7.1|-2.4|0.329
91529663|NCT03615482|182935758|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||||0.6|-0.6|
91529664|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.66||||0.004|TWO_SIDED|95.0|0.54|0.82|||cLDA|GMT ratio, 95% CI and p-value were estimated from a constrained longitudinal data analysis (cLDA) model including all vaccinated participants.||Serotype 1||0.82|0.54|0.004
91733444|NCT02958865|183361322|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.0003|TWO_SIDED|90.0|23.5|60.5|||Chan and Zhang Method|||||60.5|23.5|0.0003
91733445|NCT02958865|183361322|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.0773|TWO_SIDED|90.0|-4.0|35.1|||Chan and Zhang method|||||35.1|-4.0|0.0773
91733446|NCT02958865|183361322|SUPERIORITY||Mean Difference (Final Values)|29.2||||0.0136|TWO_SIDED|90.0|5.6|47.0|||Chan and Zhang method|||||47.0|5.6|0.0136
91733447|NCT02958865|183361322|SUPERIORITY||Mean Difference (Final Values)|37.7||||0.0015|TWO_SIDED|90.0|13.9|54.7|||Chan and Zhang method|||||54.7|13.9|0.0015
91733448|NCT02958865|183361323|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
91733449|NCT02958865|183361323|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
91733450|NCT02958865|183361323|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
91733451|NCT02958865|183361323|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3777|TWO_SIDED|90.0|-8.6|9.7|||Chan and Zhang method|||||9.7|-8.6|0.3777
91733452|NCT02958865|183361323|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.0212|TWO_SIDED|90.0|2.9|28.6|||Chan and Zhang method|||||28.6|2.9|0.0212
91733453|NCT02958865|183361323|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0742|TWO_SIDED|90.0|-4.2|18.4|||Chan and Zhang method|||||18.4|-4.2|0.0742
91495000|NCT04974697|182861639|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|10.0|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|2.8|17.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.3|2.8|
91733454|NCT02958865|183361324|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.0872|TWO_SIDED|90.0|-3.4|17.1|||Chan and Zhang method|||||17.1|-3.4|0.0872
91733455|NCT02958865|183361324|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.0254|TWO_SIDED|90.0|3.0|27.5|||Chan and Zhang method|||||27.5|3.0|0.0254
91733456|NCT02958865|183361324|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.0034|TWO_SIDED|90.0|11.0|38.1|||Chan and Zhang Method|||||38.1|11.0|0.0034
91733457|NCT02958865|183361324|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.1565|TWO_SIDED|90.0|-4.5|15.4|||Chan and Zhang method|||||15.4|-4.5|0.1565
91733458|NCT02958865|183361324|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
91733459|NCT02958865|183361324|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
91733460|NCT02958865|183361325|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
91733461|NCT02958865|183361325|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
91733462|NCT02958865|183361325|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
91733463|NCT02958865|183361325|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-11.3|6.1|||Chan and Zhang method|||||6.1|-11.3|1.0000
91733464|NCT02958865|183361325|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
91733465|NCT02958865|183361325|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.1593|TWO_SIDED|90.0|-4.4|15.7|||Chan and Zhang method|||||15.7|-4.4|0.1593
91733466|NCT00635050|183361362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|||||||||||||
91759431|NCT01865448|183411668|SUPERIORITY_OR_OTHER|||||||0.3774|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3774
91759432|NCT01865448|183411668|SUPERIORITY_OR_OTHER|||||||0.1811|TWO_SIDED||||||Paired t-test|||||||0.1811
91759433|NCT01865448|183411669|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
91759434|NCT01865448|183411669|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
91759435|NCT01865448|183411669|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
91759436|NCT01865448|183411670|SUPERIORITY_OR_OTHER|||||||0.5893|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5893
91759437|NCT01865448|183411670|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0431
91759438|NCT01865448|183411670|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0066
91759439|NCT01865448|183411671|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
91759440|NCT01865448|183411671|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
91759441|NCT01865448|183411671|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
91759442|NCT01865448|183411672|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9850
91759443|NCT01865448|183411672|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
91759444|NCT01865448|183411672|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Paired t-test|||||||0.0062
91759445|NCT01865448|183411673|SUPERIORITY_OR_OTHER|||||||0.1946|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1946
91759446|NCT01865448|183411673|SUPERIORITY_OR_OTHER|||||||0.2337|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2337
91759447|NCT01865448|183411673|SUPERIORITY_OR_OTHER|||||||0.9188|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.9188
91759448|NCT01865448|183411674|SUPERIORITY_OR_OTHER|||||||0.7964|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7964
91759449|NCT01865448|183411674|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7680
91759450|NCT01865448|183411674|SUPERIORITY_OR_OTHER|||||||0.5669|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5669
91495001|NCT03302234|182861640|OTHER||Hazard Ratio (HR)|1.08||||0.74156|TWO_SIDED|95.0|0.85|1.37||One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|||1.37|0.85|0.74156
91733467|NCT04380142|183361373|SUPERIORITY||Least Squares (LS) Mean of Difference|1.75|STANDARD_ERROR_OF_MEAN|0.65||0.0083|TWO_SIDED|95.0|0.46|3.05||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||3.05|0.46|0.0083
91495002|NCT03302234|182861641|OTHER||Hazard Ratio (HR)|1.06||||0.7172|TWO_SIDED|95.0|0.86|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||1.30|0.86|0.71720
91495003|NCT03302234|182861642|OTHER||Difference in percentage|-0.1||||0.50644|TWO_SIDED|95.0|-8.2|8.1|||Miettinen & Nurminen method|One-sided p-value for testing|Based on Miettinen \& Nurminen method stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||8.1|-8.2|0.50644
91733468|NCT04380142|183361374|SUPERIORITY||LS Mean of Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.63||0.0054|TWO_SIDED|95.0|-3.03|-0.54||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||-0.54|-3.03|0.0054
91733469|NCT04380142|183361375|SUPERIORITY||LS Mean of Difference|-1.58|STANDARD_ERROR_OF_MEAN|1.05||0.1318|TWO_SIDED|95.0|-3.65|0.48||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||0.48|-3.65|0.1318
91733470|NCT04380142|183361376|SUPERIORITY||Odds Ratio (OR)|0.12|STANDARD_ERROR_OF_MEAN|0.49|<=|0.001|TWO_SIDED|95.0|0.04|0.31||The generalized linear mixed model: status = treatment country visit baseline treatment\*visit. The unstructured variance-covariance structure is used.|generalized linear mixed model|||||0.31|0.04|<=0.001
91733471|NCT04380142|183361377|SUPERIORITY||Odds Ratio (OR)|1.81|STANDARD_ERROR_OF_MEAN|0.68||0.0091|TWO_SIDED|95.0|0.46|3.16|||generalized linear mixed model|||||3.16|0.46|0.0091
91733472|NCT04380142|183361378|SUPERIORITY||LS Mean of Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.32|<=|0.001|TWO_SIDED|95.0|-8.03|-2.78||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-2.78|-8.03|<=0.001
91733473|NCT04380142|183361379|SUPERIORITY||Least Squares (LS) Mean of Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.04||0.047|TWO_SIDED|95.0|-8.14|-0.05||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-0.05|-8.14|0.0470
91733474|NCT04380142|183361380|SUPERIORITY||LS Mean of Difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0566|TWO_SIDED|95.0|-0.001|0.1||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||0.100|-0.001|0.0566
91733475|NCT04380142|183361381|SUPERIORITY||LS Mean of Difference|1.72|STANDARD_ERROR_OF_MEAN|0.72||0.0184|TWO_SIDED|95.0|0.3|3.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||3.15|0.30|0.0184
91733476|NCT04380142|183361382|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.69||0.7989|TWO_SIDED|95.0|-1.2|1.55||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.55|-1.20|0.7989
91733477|NCT04380142|183361383|SUPERIORITY||LS Mean of Difference|-2.73|STANDARD_ERROR_OF_MEAN|1.96||0.1656|TWO_SIDED|95.0|-6.61|1.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.15|-6.61|0.1656
91733478|NCT04380142|183361384|SUPERIORITY||LS Mean of Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.65||0.1347|TWO_SIDED|95.0|-12.71|1.73||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.73|-12.71|0.1347
91733479|NCT00209131|183361391|NON_INFERIORITY_OR_EQUIVALENCE||||||<|0.05||95.0|||||Other|||No analysis was conducted.||||<0.05
91495004|NCT03302234|182861644|OTHER||Hazard Ratio (HR)|0.9815||||0.9112|TWO_SIDED|95.0|0.7386|1.3042|||Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|||1.3042|0.7386|0.9112
91529665|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.09|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 3||1.09|0.81|<0.001
91733480|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 1: the ratio of GMT (GMR) (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.92|0.66|
91759451|NCT01865448|183411675|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0320
91759452|NCT01865448|183411675|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0220
91759453|NCT01865448|183411675|SUPERIORITY_OR_OTHER|||||||0.4563|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4563
91759454|NCT01865448|183411676|SUPERIORITY_OR_OTHER|||||||0.72828|TWO_SIDED||||||Fisher Exact|||Between-Group Comparison||||0.72828
91733481|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.89|||||TWO_SIDED|95.0|0.79|0.99||||||Serotype 3: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.79|
91733482|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||Serotype 4: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.94|0.67|
91733483|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||Serotype 5: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.91|0.65|
91733484|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.87|||||TWO_SIDED|95.0|0.73|1.05||||||Serotype 6A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.05|0.73|
91495005|NCT03302234|182861647|OTHER||Difference in LS Means|-0.42||||0.8151|TWO_SIDED|95.0|-3.96|3.12|||cLDA Model|Constrained longitudinal data analysis (cLDA) Model|Based on a cLDA model with PRO scores as response variable, with covariates for treatment by time interaction, and stratification factors (ECOG, geographic region of the enrolling site, \& predominant tumor histology) as covariates.|||3.12|-3.96|0.8151
91529666|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.69|1.01|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 4||1.01|0.69|<0.001
91733485|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.91|||||TWO_SIDED|95.0|0.77|1.08||||||Serotype 6B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.08|0.77|
91733486|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.84|||||TWO_SIDED|95.0|0.75|0.93||||||Serotype 7F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.93|0.75|
91733487|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.88|||||TWO_SIDED|95.0|0.76|1.02||||||Serotype 9V: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.02|0.76|
91495006|NCT02216591|182861659|SUPERIORITY|||||||0.013|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.||||||.013
91495007|NCT02216591|182861660|SUPERIORITY|||||||0.274|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274||||||.274
91495008|NCT02216591|182861661|SUPERIORITY|||||||0.41|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410||||||.410
91495009|NCT01372462|182861662|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||The primary endpoint was difference in endurance between nasal cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD, and α=0.05, a sample size of 15 yielded 85% power.||||<0.05
91495010|NCT01372462|182861662|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91495011|NCT01372462|182861662|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91495012|NCT01372462|182861663|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons test||||< 0.05
91495013|NCT01372462|182861663|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91495014|NCT01372462|182861663|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91495015|NCT01372462|182861664|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons tests|ANOVA|Newman-Keuls multiple comparisons tests||Per protocol||||<0.05
91495016|NCT01372462|182861664|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91495017|NCT01372462|182861664|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91733488|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|1.09|||||TWO_SIDED|95.0|0.92|1.29||||||Serotype 14: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.29|0.92|
91733489|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.73|||||TWO_SIDED|95.0|0.62|0.85||||||Serotype 18C: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.85|0.62|
91733490|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.74|||||TWO_SIDED|95.0|0.63|0.86||||||Serotype 19A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.86|0.63|
91495018|NCT01125605|182861681|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed||||0.0033
91495019|NCT01125605|182861681|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit1) and last observation by duration of treatment||||0.0002
91495020|NCT01125605|182861682|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||||||0.0014
91495021|NCT01125605|182861683|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Fisher Exact|||||||0.0125
91495022|NCT01125605|182861684|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Fisher Exact|||||||0.0006
91495023|NCT01125605|182861685|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||Fisher Exact|||||||0.0016
91495024|NCT01125605|182861686|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact|||||||0.0504
91495025|NCT01125605|182861688|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||||||0.0002
91495026|NCT02674529|182861759|OTHER|This was a mechanistic trial and non-inferiority or equivalence analysis were not performed.|regression coefficient|-1.29864|STANDARD_ERROR_OF_MEAN|2.3||0.58|TWO_SIDED|95.0|||||Regression, Linear|Drug (antidepressant vs. placebo) prediction of changes in mood as measured by the MADRS scores.||||||0.58
91495027|NCT02674529|182861759|OTHER||r|0.02||||0.05|TWO_SIDED||||||Correlation|Change in MADRS after 8 weeks correlation with brain responses during the baseline fMRI task.||||||0.05
91495028|NCT02674529|182861760|OTHER|This is a mechanistic trial, we did not perform non-inferiority or equivalence analysis.|regression coefficient|-1.4328918|STANDARD_DEVIATION|1.4||0.8|TWO_SIDED|95.0|||||Regression, Linear|||||||0.8
91495029|NCT02674529|182861761|OTHER||||||<|0.05||||||The resulting voxel-wise parametric maps are thresholded with height and extent values generated by Monte Carlo simulations with 3dClustSim to protect against overall type I error at p \< 0.05.|t-test, 2 sided|||At the group-level, a random-effects analysis determines the main effects of the regressors of interest (e.g., high vs. low expectancy) resulting in statistical parametric maps (t or F statistics). To control for potential confounders, sex and depression severity will be entered as covariates in statistical models.||||<0.05
91495030|NCT03761277|182861781|NON_INFERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|ONE_SIDED|97.5||-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit.|Due to non-normality, the non-inferiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and the upper 97.5% confidence limit are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1||< 0.001
91495031|NCT03761277|182861781|SUPERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|TWO_SIDED|95.0|-22.7|-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit.|Due to non-normality, the superiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and 95% confidence interval are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1|-22.7|< 0.001
91495032|NCT00759031|182861784|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91495033|NCT00543140|182861785|SUPERIORITY_OR_OTHER|||||||0.6919|TWO_SIDED|||||No adjustments for multiple comparisons were performed as only one hypothesis was tested in this study. The level of significance was set at 0.05.|Exact Binomial method|||The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.||||0.6919
91495034|NCT02483520|182861799|SUPERIORITY||LSM Estimate|0.03||||0.977|TWO_SIDED|95.0|-2.02|2.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||2.08|-2.02|.977
91529667|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 5||0.98|0.64|<0.001
91529668|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.71|1.0|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6A||1.00|0.71|<0.001
91529669|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.74|1.04|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6B||1.04|0.74|<0.001
91529670|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.75|0.99|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 7F||0.99|0.75|<0.001
91529671|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.86|1.15|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 9V||1.15|0.86|<0.001
91529672|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 14||1.08|0.77|<0.001
91529673|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.92|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 18C||0.92|0.68|<0.001
91529674|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19A||0.95|0.73|<0.001
91529675|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19F||1.17|0.89|<0.001
91702363|NCT00772005|183299667|SUPERIORITY_OR_OTHER|||||||0.0807||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0807
91733491|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 19F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.76|0.53|
91733492|NCT04875533|183361397|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||Serotype 23F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.65|
91733493|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|0.58|||||TWO_SIDED|95.0|0.5|0.67||||||Serotype 8: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.67|0.50|
91733494|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.14|||||TWO_SIDED|95.0|1.8|2.53||||||Serotype 10A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.53|1.80|
91733495|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.72|||||TWO_SIDED|95.0|1.44|2.06||||||Serotype 11A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.06|1.44|
91733496|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.68|||||TWO_SIDED|95.0|1.39|2.04||||||Serotype 12F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.04|1.39|
91733497|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.13|||||TWO_SIDED|95.0|1.72|2.64||||||Serotype 15B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.64|1.72|
91733498|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.62|||||TWO_SIDED|95.0|1.33|1.98||||||Serotype 22F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.98|1.33|
91529676|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.64|0.91|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 22F||0.91|0.64|<0.001
91733499|NCT04875533|183361398|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.14|||||TWO_SIDED|95.0|0.97|1.34||||||Serotype 33F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.34|0.97|
91733500|NCT01299961|183361407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_DEVIATION|13.1|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.||||<0.01
91733501|NCT01299961|183361408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.7|<|0.01|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.||||<0.01
91733502|NCT01299961|183361409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|3.7||0.19|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.||||0.19
91733503|NCT02904096|183361410|NON_INFERIORITY|Estimates for PA, PB, and PA-PB were reported together with one-sided 95% confidence interval (CI) for PA-PB constructed via the Farrington-Manning likelihood method. Here PA and PB are the percentage of subjects in Group A and B (Non-inferiority margin = 12%).|Difference in percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
91495035|NCT02483520|182861800|SUPERIORITY||LSM Estimate|-0.22||||0.812|TWO_SIDED|95.0|-2.09|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-2.09|.812
91495036|NCT02483520|182861803|SUPERIORITY||LSM Estimate|-1.5||||0.343|TWO_SIDED|95.0|-4.64|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-4.64|.343
91495037|NCT02483520|182861804|SUPERIORITY||LSM Estimate|-4.79||||0.012|TWO_SIDED|95.0|-8.51|-1.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||-1.08|-8.51|.012
91733504|NCT02904096|183361411|OTHER||Difference in Percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
91733505|NCT02904096|183361412|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.||||<.001
91733506|NCT02904096|183361412|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
91733507|NCT02904096|183361412|OTHER|||||||0.054|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.||||.054
91733508|NCT02904096|183361412|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
91733509|NCT02904096|183361412|OTHER|||||||0.049|||||||t-test, 1 sided|||Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.||||.049
91733510|NCT02904096|183361412|OTHER|||||||0.003|||||||t-test, 1 sided|||Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.||||.003
91702364|NCT00772005|183299667|SUPERIORITY_OR_OTHER|||||||0.2959||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2959
91702365|NCT00772005|183299668|SUPERIORITY_OR_OTHER|||||||0.6759||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6759
91702366|NCT00772005|183299668|SUPERIORITY_OR_OTHER|||||||0.2418||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2418
91702367|NCT00772005|183299668|SUPERIORITY_OR_OTHER|||||||0.9808||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9808
91702368|NCT00772005|183299669|SUPERIORITY_OR_OTHER|||||||0.7599||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7599
91702369|NCT00772005|183299669|SUPERIORITY_OR_OTHER|||||||0.4543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4543
91702370|NCT00772005|183299669|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6040
91702371|NCT00772005|183299670|SUPERIORITY_OR_OTHER|||||||0.2476||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2476
91702372|NCT00772005|183299670|SUPERIORITY_OR_OTHER|||||||0.949||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9490
91702373|NCT00772005|183299670|SUPERIORITY_OR_OTHER|||||||0.9035||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9035
91495038|NCT02483520|182861805|SUPERIORITY||LSM Estimate|0.77||||0.033|TWO_SIDED|95.0|0.07|1.47|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.47|0.07|.033
91495039|NCT02483520|182861808|SUPERIORITY|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.211
91733511|NCT02904096|183361412|OTHER|||||||0.781|||||||t-test, 1 sided|||Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.||||.781
91733512|NCT02904096|183361412|OTHER|||||||0.573|||||||t-test, 1 sided|||Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.||||.573
91733513|NCT02904096|183361413|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
91733514|NCT02904096|183361413|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
91733515|NCT02904096|183361413|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
91733516|NCT02904096|183361413|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
91733517|NCT02904096|183361414|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
91733518|NCT02904096|183361414|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
91733519|NCT02904096|183361414|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
91733520|NCT02904096|183361414|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
91733521|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
91733522|NCT02904096|183361415|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.001
91733523|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
91495040|NCT02483520|182861808|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||<.001
91495041|NCT02483520|182861809|SUPERIORITY|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.476
91733524|NCT02904096|183361415|OTHER|||||||0.002|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.002
91733525|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
91733526|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
91733527|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
91733528|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
91733529|NCT02904096|183361415|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||.001
91733530|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
91733531|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
91733532|NCT02904096|183361415|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
91733533|NCT02904096|183361415|OTHER|||||||0.01|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.010
91733534|NCT02904096|183361415|OTHER|||||||0.06|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.060
91733535|NCT02904096|183361415|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.177
91733536|NCT02904096|183361415|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.177
91759455|NCT01618695|183411678|SUPERIORITY||Median Difference (Final Values)|-5.09||||0.233|TWO_SIDED|95.0|-14.112|4.519|||ANCOVA||Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.|||4.519|-14.112|0.2330
91733537|NCT00980798|183361420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2365||||0.1212|TWO_SIDED|95.0|-0.5357|0.0627||No adjustment for multiple comparisons necessary, as only 1 primary hypothesis was tested. Threshold for statistical significance was 0.05.|Mixed-model regression analysis|The difference above is presented as the difference OROS hydromorphone HCl minus placebo, so negative scores favour OROS hydromorphone HCl.|The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee.|The F test for treatment tested the null hypothesis of no treatment difference. Assuming that 3 baseline measures and 7 post baseline measures were collected 81 patients were required per group to detect a difference of 1 point in the BPI measure with 90% power at a significance level of 5%. To allow for a drop-out rate of approximately 40%, the study planned to recruit 135 patients per group (i.e. 270 in total).||0.0627|-0.5357|0.1212
91733538|NCT02757768|183361437|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.039|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.039
91733539|NCT02757768|183361438|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.558|TWO_SIDED|95.0|-0.46|0.25|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.25|-0.46|0.558
91733540|NCT02757768|183361438|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.89|-0.14|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.14|-0.89|0.007
91733541|NCT02757768|183361438|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.041|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.041
91733542|NCT02757768|183361439|SUPERIORITY||LS Mean of Difference|3.87|STANDARD_ERROR_OF_MEAN|2.8||0.167|TWO_SIDED|95.0|-1.63|9.37|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||9.37|-1.63|0.167
91733543|NCT02757768|183361439|SUPERIORITY||LS Mean of Difference|6.29|STANDARD_ERROR_OF_MEAN|3.28||0.056|TWO_SIDED|95.0|-0.15|12.73|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||12.73|-0.15|0.056
91733544|NCT02757768|183361439|SUPERIORITY||LS Mean of Difference|8.99|STANDARD_ERROR_OF_MEAN|3.58||0.012|TWO_SIDED|95.0|1.97|16.01|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||16.01|1.97|0.012
91733545|NCT02757768|183361439|SUPERIORITY||LS Mean of Difference|9.25|STANDARD_ERROR_OF_MEAN|3.43||0.007|TWO_SIDED|95.0|2.53|15.98|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||15.98|2.53|0.007
91733546|NCT02757768|183361440|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.747|TWO_SIDED|95.0|-0.63|0.38|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.63|0.747
91733547|NCT02757768|183361440|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.393|TWO_SIDED|95.0|-0.72|0.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.54|-0.72|0.393
91733548|NCT02757768|183361440|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.32||0.672|TWO_SIDED|95.0|-0.87|0.38|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.87|0.672
91733549|NCT02757768|183361440|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.64|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.30|-0.90|0.640
91759456|NCT01618695|183411678|SUPERIORITY||Median Difference (Final Values)|-16.45||||0.0003|TWO_SIDED|95.0|-25.683|-7.251|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-7.251|-25.683|0.0003
91759457|NCT01618695|183411678|SUPERIORITY||Median Difference (Final Values)|-24.95|||<|0.0001|TWO_SIDED|95.0|-33.878|-16.235|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-16.235|-33.878|<0.0001
91759458|NCT01618695|183411679|SUPERIORITY|||||||0.3954|||||||Cochran-Mantel-Haenszel|||||||0.3954
91759459|NCT01618695|183411679|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
91759460|NCT01618695|183411679|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91759461|NCT01618695|183411680|SUPERIORITY||Median Difference (Final Values)|-8.27||||0.0552|TWO_SIDED|95.0|-18.067|1.671|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||1.671|-18.067|0.0552
91759462|NCT01618695|183411680|SUPERIORITY||Median Difference (Final Values)|-21.21|||<|0.0001|TWO_SIDED|95.0|-30.941|-11.368|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-11.368|-30.941|<0.0001
91495042|NCT02483520|182861809|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.005
91495043|NCT02483520|182861810|SUPERIORITY|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.677
91495044|NCT02483520|182861810|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.020
91733550|NCT02757768|183361441|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|-0.68|0.16|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.16|-0.68|0.222
91733551|NCT02757768|183361441|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.003|TWO_SIDED|95.0|-1.18|-0.24|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.24|-1.18|0.003
91733552|NCT02757768|183361441|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.17|-1.13|0.008
91733553|NCT02757768|183361441|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.21|-1.13|0.004
91733554|NCT02757768|183361442|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.723|TWO_SIDED|95.0|-0.6|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.6|0.723
91495045|NCT02483520|182861811|SUPERIORITY||LSM Estimate|-0.62||||0.432|TWO_SIDED|95.0|-2.18|0.94|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||0.94|-2.18|.432
91495046|NCT02483520|182861812|SUPERIORITY|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||.255
91495047|NCT01104493|182861817|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|rate difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6|||score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.||2.6|-5.2|
91733555|NCT02757768|183361442|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.7|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.0|-0.7|0.700
91733556|NCT02757768|183361442|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-1.3|0.400
91759463|NCT01618695|183411680|SUPERIORITY||Median Difference (Final Values)|-28.65|||<|0.0001|TWO_SIDED|95.0|-37.698|-19.794|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-19.794|-37.698|<0.0001
91759464|NCT00931606|183411692|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759465|NCT00931606|183411692|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759466|NCT00931606|183411692|SUPERIORITY|||||||0.524|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.524
91759467|NCT00931606|183411692|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759468|NCT00931606|183411692|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
91759469|NCT00931606|183411692|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
91759470|NCT00931606|183411692|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
91759471|NCT00931606|183411692|SUPERIORITY|||||||0.236|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.236
91759472|NCT00931606|183411692|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
91759473|NCT00931606|183411692|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
91759474|NCT00931606|183411695|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759475|NCT00931606|183411695|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759476|NCT00931606|183411695|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
91759477|NCT00931606|183411695|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
91529677|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.7|1.03|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 23F||1.03|0.70|<0.001
91495048|NCT02033694|182861824|OTHER||Cox Proportional Hazard|1.21||||0.0004|TWO_SIDED|95.0|1.09|1.35|||Regression, Cox|||Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.||1.35|1.09|0.0004
91495049|NCT02033694|182861824|OTHER||Cox Proportional Hazard|1.45|||<|0.0001|TWO_SIDED|95.0|1.3|1.6|||Regression, Cox|||Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.||1.60|1.30|<0.0001
91495050|NCT02033694|182861825|OTHER||Cox Proportional Hazard|2.18|||<|0.0001|TWO_SIDED|95.0|1.48|3.22|||Regression, Cox|||Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 as the independent variable and NC-MACE during 2 years as the outcome.||3.22|1.48|<0.0001
91759478|NCT00931606|183411696|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759479|NCT00931606|183411696|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759480|NCT00931606|183411696|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
91759481|NCT00931606|183411696|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759482|NCT00931606|183411696|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
91759483|NCT00931606|183411696|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
91759484|NCT00931606|183411696|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
91759485|NCT00931606|183411696|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
91759486|NCT00931606|183411696|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
91759487|NCT00931606|183411696|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
91759488|NCT00931606|183411696|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
91759489|NCT00931606|183411697|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759490|NCT00931606|183411697|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759491|NCT00931606|183411697|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
91759492|NCT00931606|183411697|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
91759493|NCT00931606|183411697|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
91759494|NCT00931606|183411697|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
91759495|NCT00931606|183411697|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
91759496|NCT00931606|183411697|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
91759497|NCT00931606|183411697|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
91759498|NCT00931606|183411697|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
91759499|NCT00931606|183411697|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
91759500|NCT02391363|183411751|SUPERIORITY|||||||0.77||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05."||||0.77
91759501|NCT02391363|183411752|SUPERIORITY|||||||0.07||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.07
91495051|NCT02033694|182861825|OTHER||Cox Proportional Hazard|4.22|||<|0.0001|TWO_SIDED|95.0|2.39|7.45|||Regression, Cox|||Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.||7.45|2.39|<0.0001
91733557|NCT02757768|183361442|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.812|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-1.0|0.812
91733558|NCT02757768|183361443|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.121|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.1|0.121
91733559|NCT02757768|183361443|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.241|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-0.2|0.241
91733560|NCT02757768|183361443|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.843|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-0.6|0.843
91733561|NCT02757768|183361443|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.679|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.7|-0.4|0.679
91733562|NCT02757768|183361444|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.175|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.7|0.175
91733563|NCT02757768|183361444|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.6|0.430
91733564|NCT02757768|183361444|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.141|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.8|0.141
91733565|NCT02757768|183361444|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.288|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.7|0.288
91495052|NCT02111772|182861826|SUPERIORITY|||||||0.049|||||||Negative binomial regression|||||||0.049
91495053|NCT02111772|182861827|SUPERIORITY||||||<|0.001|||||||Negative binomial regression|||||||<0.001
91495054|NCT01425281|182861840|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm \[258 lesions\] vs Xience arm \[130 lesions\]).||||0.49
91733566|NCT02757768|183361445|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.3|0.128
91733567|NCT02757768|183361445|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.054
91733568|NCT02757768|183361445|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.079|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.079
91733569|NCT02757768|183361445|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.148|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.4|0.148
91733570|NCT02757768|183361446|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|95.0|-0.61|0.39|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.39|-0.61|0.660
91495055|NCT01425281|182861841|NON_INFERIORITY|Using t-test with non-inferiority margin of 0.140mm||||||0.78|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.||||0.78
91733571|NCT02757768|183361446|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.767|TWO_SIDED|95.0|-0.72|0.53|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.53|-0.72|0.767
91495056|NCT02509156|182861983|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.57||0.746|TWO_SIDED|95.0|-4.52|6.11|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||6.11|-4.52|0.746
91495057|NCT02509156|182861984|SUPERIORITY||slope of time|1.53|STANDARD_ERROR_OF_MEAN|0.63||0.024|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.024
91733572|NCT02757768|183361446|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.372|TWO_SIDED|95.0|-0.89|0.34|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.89|0.372
91733573|NCT02757768|183361446|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.3||0.272|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.26|-0.92|0.272
91733574|NCT02757768|183361447|SUPERIORITY||LS Mean of Difference|-1.75|STANDARD_ERROR_OF_MEAN|1.3||0.179|TWO_SIDED|95.0|-4.29|0.8|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-4.29|0.179
91733575|NCT02757768|183361447|SUPERIORITY||LS Mean of Difference|-3.84|STANDARD_ERROR_OF_MEAN|1.41||0.006|TWO_SIDED|95.0|-6.6|-1.08|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-1.08|-6.60|0.006
91733576|NCT02757768|183361447|SUPERIORITY||LS Mean of Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.51||0.055|TWO_SIDED|95.0|-5.86|0.06|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.06|-5.86|0.055
91733577|NCT02757768|183361447|SUPERIORITY||LS Mean of Difference|-2.11|STANDARD_ERROR_OF_MEAN|1.48||0.154|TWO_SIDED|95.0|-5.02|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-5.02|0.154
91733578|NCT02757768|183361448|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|1.13||0.233|TWO_SIDED|95.0|-3.57|0.87|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.87|-3.57|0.233
91733579|NCT02757768|183361448|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.2||0.698|TWO_SIDED|95.0|-1.89|2.82|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.82|-1.89|0.698
91733580|NCT02757768|183361448|SUPERIORITY||LS Mean of Difference|0.89|STANDARD_ERROR_OF_MEAN|1.28||0.486|TWO_SIDED|95.0|-1.62|3.4|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.40|-1.62|0.486
91733581|NCT02757768|183361448|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.968|TWO_SIDED|95.0|-2.52|2.42|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.42|-2.52|0.968
91733582|NCT02757768|183361449|SUPERIORITY||LS Mean of Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.36||0.165|TWO_SIDED|95.0|-4.56|0.78|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.78|-4.56|0.165
91733583|NCT02757768|183361449|SUPERIORITY||LS Mean of Difference|0.76|STANDARD_ERROR_OF_MEAN|1.41||0.592|TWO_SIDED|95.0|-2.02|3.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.54|-2.02|0.592
91733584|NCT02757768|183361449|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|1.54||0.559|TWO_SIDED|95.0|-2.12|3.92|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.92|-2.12|0.559
91733585|NCT02757768|183361449|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|1.51||0.985|TWO_SIDED|95.0|-2.94|3.0|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.00|-2.94|0.985
91733586|NCT02757768|183361450|SUPERIORITY||LS Mean of Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.29||0.161|TWO_SIDED|95.0|-4.35|0.72|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.72|-4.35|0.161
91733587|NCT02757768|183361450|SUPERIORITY||LS Mean of Difference|0.35|STANDARD_ERROR_OF_MEAN|1.38||0.798|TWO_SIDED|95.0|-2.36|3.07|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.07|-2.36|0.798
91733588|NCT02757768|183361450|SUPERIORITY||LS Mean of Difference|1.17|STANDARD_ERROR_OF_MEAN|1.42||0.408|TWO_SIDED|95.0|-1.61|3.95|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.95|-1.61|0.408
91733589|NCT02757768|183361450|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|1.39||0.919|TWO_SIDED|95.0|-2.6|2.88|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.88|-2.60|0.919
91733590|NCT02757768|183361451|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|1.49||0.99|TWO_SIDED|95.0|-2.94|2.91|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.91|-2.94|0.990
91733591|NCT02757768|183361451|SUPERIORITY||LS Mean of Difference|0.92|STANDARD_ERROR_OF_MEAN|1.55||0.554|TWO_SIDED|95.0|-2.12|3.96|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.96|-2.12|0.554
91733592|NCT02757768|183361451|SUPERIORITY||LS Mean of Difference|1.53|STANDARD_ERROR_OF_MEAN|1.63||0.348|TWO_SIDED|95.0|-1.67|4.73|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||4.73|-1.67|0.348
91495058|NCT02509156|182861985|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.94||0.328|TWO_SIDED|95.0|-2.68|1.26|||ANCOVA||Confidence intervals based on t-test|The change in global strain was compared using ANCOVA analyses adjusting for baseline values.||1.26|-2.68|0.328
91495059|NCT02509156|182861986|SUPERIORITY||slope of time|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.261|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.261
91495060|NCT02509156|182861987|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|1.41||0.071|TWO_SIDED|95.0|-4.51|1.35|||ANCOVA||Confidence intervals based on t-test|The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.||1.35|-4.51|0.071
91529678|NCT03615482|182935759|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.72|0.96|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 33F||0.96|0.72|<0.001
91733593|NCT02757768|183361451|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|1.6||0.876|TWO_SIDED|95.0|-2.89|3.38|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.38|-2.89|0.876
91733594|NCT02757768|183361452|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.05||0.293|TWO_SIDED|95.0|-3.16|0.95|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.95|-3.16|0.293
91733595|NCT02757768|183361452|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.773|TWO_SIDED|95.0|-2.52|1.87|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.87|-2.52|0.773
91733596|NCT02757768|183361452|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.12||0.94|TWO_SIDED|95.0|-2.28|2.11|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.11|-2.28|0.940
91733597|NCT02757768|183361452|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1||0.516|TWO_SIDED|95.0|-2.86|1.44|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.44|-2.86|0.516
91733598|NCT02757768|183361453|SUPERIORITY|||||||0.4591|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 4 Placebo vs. Mirabegron.||||0.4591
91733599|NCT02757768|183361453|SUPERIORITY|||||||0.4073|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 8 Placebo vs. Mirabegron.||||0.4073
91733600|NCT02757768|183361453|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 12 Placebo vs. Mirabegron.||||0.7740
91733601|NCT02757768|183361453|SUPERIORITY|||||||0.5121|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||EoT Placebo vs. Mirabegron.||||0.5121
91495061|NCT02509156|182861988|SUPERIORITY||slope of time|-0.14|STANDARD_ERROR_OF_MEAN|0.35||0.689|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.689
91495062|NCT02509156|182861989|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|6.46||0.935|TWO_SIDED|95.0|-12.33|14.45|||ANCOVA||Confidence intervals based on t-test|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.||14.45|-12.33|0.935
91495063|NCT02509156|182861990|SUPERIORITY||slope of time|-1.56|STANDARD_ERROR_OF_MEAN|1.55||0.325|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.325
91495064|NCT02509156|182861991|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|5.99||0.919|TWO_SIDED|95.0|-11.75|13.08|||ANCOVA||Confidence intervals based on t-test|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.||13.08|-11.75|0.919
91529679|NCT03615482|182935760|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.25|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H1N1||1.25|0.94|<0.001
91529680|NCT03615482|182935760|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H3N2||1.17|0.90|<0.001
91529681|NCT03615482|182935760|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.86|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Victoria||1.08|0.86|<0.001
91529682|NCT03615482|182935760|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.13|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Yamagata||1.13|0.90|<0.001
91529683|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||Serotype 1||0.89|0.67|
91529684|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||Serotype 3||0.99|0.76|
91529685|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 4||0.91|0.68|
91733602|NCT02757768|183361454|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.223|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.223
91733603|NCT02757768|183361454|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.598
91733604|NCT02757768|183361454|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.3|0.312
91529686|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 5||1.02|0.77|
91529687|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.87||||||Serotype 6A||0.87|0.61|
91529688|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 6B||0.91|0.64|
91529689|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.01||||||Serotype 7F||1.01|0.76|
91529690|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 9V||1.03|0.79|
91529691|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 14||0.99|0.73|
91529692|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 18C||0.91|0.68|
91529693|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 19A||1.02|0.78|
91529694|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03||||||Serotype 19F||1.03|0.77|
91529695|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 22F||0.89|0.65|
91529696|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 23F||0.98|0.70|
91529697|NCT03615482|182935761|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|0.99||||||Serotype 33F||0.99|0.75|
91529698|NCT02451930|182935804|OTHER|||||||0.4491|||||||Fisher Exact|||||||0.4491
91733605|NCT02757768|183361454|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.525|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.525
91495065|NCT02509156|182861992|SUPERIORITY||slope of time|-1.99|STANDARD_ERROR_OF_MEAN|1.45||0.183|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.183
91495066|NCT02509156|182861993|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.035||0.124|TWO_SIDED|95.0|0.003|0.15|||ANCOVA||Confidence intervals based on t-test|The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.||0.15|0.003|0.124
91733606|NCT02757768|183361456|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.226|TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.08|0.226
91495067|NCT02509156|182861994|SUPERIORITY|||||||||||||||||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.|There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.|||
91495068|NCT02509156|182861995|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.14||0.993|TWO_SIDED|95.0|-3.05|1.74|||ANCOVA||Confidence intervals based on t-test|The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.||1.74|-3.05|0.993
91495069|NCT02509156|182861996|SUPERIORITY||slope of time|-0.44|STANDARD_ERROR_OF_MEAN|0.29||0.151|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.151
91495070|NCT02509156|182861997|SUPERIORITY||Mean Difference (Final Values)|38.03|STANDARD_ERROR_OF_MEAN|20.96||0.056|TWO_SIDED|95.0|-5.84|81.89|||ANCOVA||Confidence intervals based on t-test|The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.||81.89|-5.84|0.056
91495071|NCT02509156|182861998|SUPERIORITY||slope of time|2.82|STANDARD_ERROR_OF_MEAN|5.06||0.583|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.583
91495072|NCT02509156|182861999|SUPERIORITY||Mean Difference (Final Values)|-12.82|STANDARD_ERROR_OF_MEAN|8.37||0.048|TWO_SIDED|95.0|-30.49|4.84|||ANCOVA||Confidence intervals based on t-test|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.||4.84|-30.49|0.048
91495073|NCT02509156|182862000|SUPERIORITY||slope of time|-8.07|STANDARD_ERROR_OF_MEAN|1.86||0.0002|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.0002
91495074|NCT02509156|182862001|SUPERIORITY||Mean Difference (Final Values)|-315.8|STANDARD_ERROR_OF_MEAN|295.0||0.199|TWO_SIDED|95.0|-947.5|315.8|||ANCOVA||Confidence intervals based on t-test|The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.||315.80|-947.50|0.199
91495075|NCT02509156|182862002|SUPERIORITY||slope of time|-23.391|STANDARD_ERROR_OF_MEAN|202.08||0.229|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.||||0.229
91495076|NCT02128113|182862011|SUPERIORITY||LS Mean difference (Net)|26.95||||0.4529|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension (pooled) - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4529
91495077|NCT02128113|182862011|SUPERIORITY||LS Mean difference (Net)|64.31||||0.1276|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.1276
91495078|NCT02128113|182862011|SUPERIORITY||LS Mean difference (Net)|-11.08||||0.7996|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.7996
91495079|NCT02128113|182862012|SUPERIORITY||Difference in proportion of patients|-13.55||||0.0647|TWO_SIDED|95.0|-26.75|-0.36|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.36|-26.75|0.0647
91495080|NCT02128113|182862012|SUPERIORITY||Difference in proportion of patients|-15.15||||0.0517|TWO_SIDED|95.0|-28.34|-1.96|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||-1.96|-28.34|0.0517
91495081|NCT02128113|182862013|SUPERIORITY||Difference in proportion of patients|-0.11||||0.9258|TWO_SIDED|95.0|-8.91|8.68|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||8.68|-8.91|0.9258
91733607|NCT02757768|183361456|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.501|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.28|-0.14|0.501
91733608|NCT02757768|183361456|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.984|TWO_SIDED|95.0|-0.22|0.23|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.23|-0.22|0.984
91733609|NCT02757768|183361456|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.24|-0.18|0.780
91733610|NCT02757768|183361457|SUPERIORITY||LS Mean of Difference|3.1|STANDARD_ERROR_OF_MEAN|1.9||0.107|TWO_SIDED|95.0|-0.7|6.8|||ANCOVA|||Week 4 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.8|-0.7|0.107
91733611|NCT02757768|183361457|SUPERIORITY||LS Mean of Difference|2.5|STANDARD_ERROR_OF_MEAN|1.9||0.19|TWO_SIDED|95.0|-1.3|6.3|||ANCOVA|||Week 8 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.3|0.190
91733612|NCT02757768|183361457|SUPERIORITY||LS Mean of Difference|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.297|TWO_SIDED|95.0|-1.9|6.3|||ANCOVA|||Week 12 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.9|0.297
91733613|NCT02757768|183361457|SUPERIORITY||LS Mean of Difference|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.493|TWO_SIDED|95.0|-2.7|5.5|||ANCOVA|||EoT Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||5.5|-2.7|0.493
91733614|NCT00835367|183361458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.84||||||90.0|98.22|105.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.59|98.22|
91733615|NCT00835367|183361459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|102.53||||||90.0|99.71|105.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.44|99.71|
91495082|NCT02128113|182862013|SUPERIORITY||Difference in proportion of patients|-3.03||||0.6547|TWO_SIDED|95.0|-12.27|6.21|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||6.21|-12.27|0.6547
91733616|NCT00835367|183361460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.49||||||90.0|99.75|105.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.30|99.75|
91733617|NCT00835367|183361461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|91.79||||||90.0|84.83|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.32|84.83|
91733618|NCT00835367|183361462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.85||||||90.0|92.54|99.27|||||Metabolite presented for informational purposes only.|||99.27|92.54|
91733619|NCT00835367|183361463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.3|102.3|||||Metabolite presented for informational purposes only|||102.30|98.30|
91733620|NCT00835367|183361464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.74||||||90.0|100.35|105.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.19|100.35|
91733621|NCT00835367|183361465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.72||||||90.0|100.3|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.20|100.30|
91495083|NCT02128113|182862014|SUPERIORITY||Difference in proportion of patients|-13.56||||0.0657|TWO_SIDED|95.0|-26.84|-0.28|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.28|-26.84|0.0657
91733622|NCT00835367|183361466|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.25|102.35|||||Metabolite presented for informational purposes only.|||102.35|98.25|
91733623|NCT00835172|183361467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|92.1|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|92.1|
91733624|NCT00835172|183361468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|96.8|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|96.8|
91733625|NCT00835172|183361469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.0||||||90.0|99.3|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|99.3|
91733626|NCT04734210|183361470|OTHER|Exploratory, descriptive analysis||||||0.2933||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.2933
91733627|NCT04734210|183361471|OTHER|Exploratory, descriptive analysis||||||0.1966||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.1966
91733628|NCT04734210|183361472|OTHER|Exploratory, descriptive analysis||||||0.0213||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.0213
91733629|NCT04023045|183361476|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733630|NCT04023045|183361477|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733631|NCT04023045|183361478|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733632|NCT04023045|183361479|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733633|NCT04023045|183361480|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91495084|NCT02128113|182862014|SUPERIORITY|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution|Difference in proportion of patients|-15.15||||0.0526|TWO_SIDED|95.0|-28.42|-1.88|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|||-1.88|-28.42|0.0526
91495085|NCT02128113|182862015|SUPERIORITY||Difference in proportion of patients|0.0||||0.8771|TWO_SIDED|95.0|-10.87|10.87|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||10.87|-10.87|0.8771
91495086|NCT02128113|182862015|SUPERIORITY||Difference in proportion of patients|1.35||||0.8248|TWO_SIDED|95.0|-9.32|12.02|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||12.02|-9.32|0.8248
91733634|NCT04023045|183361481|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733635|NCT04023045|183361482|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733636|NCT04023045|183361483|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
91733637|NCT02314923|183361513|OTHER|||||||0.951|||||||ANOVA|||||||0.951
91733638|NCT02314923|183361513|OTHER|||||||0.458|||||||ANOVA|||||||0.458
91733639|NCT02314923|183361513|OTHER|||||||0.071|||||||ANOVA|||||||0.071
91733640|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91495087|NCT02128113|182862016|SUPERIORITY||LS Mean difference (Net)|27.21||||0.4686|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4686
91733641|NCT02314923|183361513|OTHER|||||||0.029|||||||ANOVA|||||||0.029
91733642|NCT02314923|183361513|OTHER|||||||0.325|||||||ANOVA|||||||0.325
91733643|NCT02314923|183361513|OTHER|||||||0.003|||||||ANOVA|||||||0.003
91733644|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733645|NCT02314923|183361513|OTHER|||||||0.427|||||||ANOVA|||||||0.427
91733646|NCT02314923|183361513|OTHER|||||||0.065|||||||ANOVA|||||||0.065
91733647|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733648|NCT02314923|183361513|OTHER|||||||0.027|||||||ANOVA|||||||0.027
91733649|NCT02314923|183361513|OTHER|||||||0.303|||||||ANOVA|||||||0.303
91733650|NCT02314923|183361513|OTHER|||||||0.003|||||||ANOVA|||||||0.003
91733651|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733652|NCT02314923|183361513|OTHER|||||||0.286|||||||ANOVA|||||||0.286
91733653|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733654|NCT02314923|183361513|OTHER|||||||0.094|||||||ANOVA|||||||0.094
91733655|NCT02314923|183361513|OTHER|||||||0.757|||||||ANOVA|||||||0.757
91733656|NCT02314923|183361513|OTHER|||||||0.022|||||||ANOVA|||||||0.022
91733657|NCT02314923|183361513|OTHER|||||||0.001|||||||ANOVA|||||||0.001
91733658|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733659|NCT02314923|183361513|OTHER|||||||0.348|||||||ANOVA|||||||0.348
91733660|NCT02314923|183361513|OTHER|||||||0.508|||||||ANOVA|||||||0.508
91733661|NCT02314923|183361513|OTHER|||||||0.191|||||||ANOVA|||||||0.191
91733662|NCT02314923|183361513|OTHER|||||||0.024|||||||ANOVA|||||||0.024
91733663|NCT02314923|183361513|OTHER|||||||0.169|||||||ANOVA|||||||0.169
91733664|NCT02314923|183361513|OTHER|||||||0.961|||||||ANOVA|||||||0.961
91733665|NCT02314923|183361513|OTHER|||||||0.454|||||||ANOVA|||||||0.454
91733666|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733667|NCT02314923|183361513|OTHER|||||||0.068|||||||ANOVA|||||||0.068
91733668|NCT02314923|183361513|OTHER|||||||0.007|||||||ANOVA|||||||0.007
91733669|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733670|NCT02314923|183361513|OTHER|||||||0.37|||||||ANOVA|||||||0.370
91733671|NCT02314923|183361513|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91733672|NCT02008617|183361518|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91733673|NCT02008617|183361519|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||At Rest||||0.86
91733674|NCT02008617|183361519|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Plantar Flexion||||0.89
91733675|NCT02008617|183361520|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91733676|NCT02008617|183361521|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
91733677|NCT00976456|183361522|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.|Hazard Ratio (HR)|1.29||||0.0583|TWO_SIDED|95.0|0.989|1.682|||Wilcoxon (Mann-Whitney)|||||1.682|0.989|0.0583
91733678|NCT00976456|183361523|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.|Hazard Ratio (HR)|1.091||||0.3869|TWO_SIDED|95.0|0.794|1.499|||Wilcoxon (Mann-Whitney)|||||1.499|0.794|0.3869
91733679|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.253|TWO_SIDED|95.0|-3.1|0.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.8|-3.1|0.253
91495088|NCT02128113|182862016|SUPERIORITY||LS Mean difference (Net)|49.99||||0.2636|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.2636
91733680|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.1||||0.919|TWO_SIDED|95.0|-2.1|1.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.9|-2.1|0.919
91733681|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.2||||0.829|TWO_SIDED|95.0|-2.2|1.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.8|-2.2|0.829
91733682|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.1||||0.074|TWO_SIDED|95.0|-4.5|0.2|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.2|-4.5|0.074
91733683|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|1.0||||0.393|TWO_SIDED|95.0|-1.3|3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||3.3|-1.3|0.393
91733684|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|2.0||||0.088|TWO_SIDED|95.0|-0.3|4.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.4|-0.3|0.088
91733685|NCT00806585|183361525|SUPERIORITY_OR_OTHER||Difference in least squares means|1.9||||0.108|TWO_SIDED|95.0|-0.4|4.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.3|-0.4|0.108
91733686|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.543|TWO_SIDED|95.0|-4.0|2.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.1|-4.0|0.543
91733687|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.8||||0.246|TWO_SIDED|95.0|-4.9|1.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.3|-4.9|0.246
91733688|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.821|TWO_SIDED|95.0|-3.5|2.7|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.7|-3.5|0.821
91733689|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.0|||<|0.001|TWO_SIDED|95.0|-10.7|-3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-3.3|-10.7|<0.001
91733690|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|6.1||||0.001|TWO_SIDED|95.0|2.4|9.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||9.8|2.4|0.001
91702374|NCT00772005|183299671|SUPERIORITY_OR_OTHER|||||||0.9472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9472
91495089|NCT02128113|182862016|SUPERIORITY||LS Mean difference (Net)|-1.74||||0.9691|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.9691
91495090|NCT01750242|182862017|SUPERIORITY_OR_OTHER_LEGACY||% of leads|86.5|||||ONE_SIDED|95.0|73.7|||||||A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.|||73.7|
91495091|NCT01750242|182862018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.5|STANDARD_DEVIATION|8.7|||TWO_SIDED|95.0|-26.5|-18.4||||||Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.||-18.4|-26.5|
91495092|NCT03765918|182862019|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.3|||<|1e-05|TWO_SIDED|95.0|6.7|12.8||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||12.8|6.7|<0.00001
91495093|NCT03765918|182862020|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|13.7|||<|1e-05|TWO_SIDED|95.0|9.7|18.7||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||18.7|9.7|<0.00001
91495094|NCT03765918|182862021|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.8|||<|1e-05|TWO_SIDED|95.0|7.0|13.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||13.3|7.0|<0.00001
91495095|NCT03765918|182862022|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.0||||0.0006|TWO_SIDED|95.0|1.5|5.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.3|1.5|0.0006
91495096|NCT03765918|182862023|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|4.2||||0.0011|TWO_SIDED|95.0|2.1|7.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||7.6|2.1|0.0011
91495097|NCT03765918|182862024|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.1||||0.0006|TWO_SIDED|95.0|1.6|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.6|1.6|0.0006
91495098|NCT03765918|182862031|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.29||||0.4671|TWO_SIDED|95.0|-4.78|2.2||Two-sided p-value based on cLDA model.|cLDA model|||||2.20|-4.78|0.4671
91495099|NCT03765918|182862032|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1606|TWO_SIDED|95.0|-7.27|1.21||Two-sided p-value based on cLDA model.|cLDA model|||||1.21|-7.27|0.1606
91495100|NCT03765918|182862033|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.41||||0.4374|TWO_SIDED|95.0|-4.96|2.15||Two-sided p-value based on cLDA model.|cLDA model|||||2.15|-4.96|0.4374
91495101|NCT03765918|182862034|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.39||||0.8379|TWO_SIDED|95.0|-3.35|4.13||Two-sided p-value based on cLDA model.|cLDA model|||||4.13|-3.35|0.8379
91495102|NCT03765918|182862035|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.39||||0.8643|TWO_SIDED|95.0|-4.84|4.07||Two-sided p-value based on cLDA model.|cLDA model|||||4.07|-4.84|0.8643
91495103|NCT03765918|182862036|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.29||||0.8813|TWO_SIDED|95.0|-4.12|3.54||Two-sided p-value based on cLDA model.|cLDA model|||||3.54|-4.12|0.8813
91495104|NCT03765918|182862043|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.34||||0.8287|TWO_SIDED|95.0|-2.76|3.45||Two-sided p-value based on cLDA model.|cLDA model|||||3.45|-2.76|0.8287
91495105|NCT03765918|182862044|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.53||||0.7761|TWO_SIDED|95.0|-3.12|4.18||Two-sided p-value based on cLDA model.|cLDA model|||||4.18|-3.12|0.7761
91495106|NCT03765918|182862045|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.65||||0.688|TWO_SIDED|95.0|-2.54|3.84||Two-sided p-value based on cLDA model.|cLDA model|||||3.84|-2.54|0.6880
91495107|NCT03765918|182862046|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.45||||0.3858|TWO_SIDED|95.0|-4.73|1.83||Two-sided p-value based on cLDA model.|cLDA model|||||1.83|-4.73|0.3858
91495108|NCT03765918|182862047|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.45||||0.237|TWO_SIDED|95.0|-6.53|1.62||Two-sided p-value based on cLDA model.|cLDA model|||||1.62|-6.53|0.2370
91495109|NCT03765918|182862048|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.76||||0.3138|TWO_SIDED|95.0|-5.2|1.67||Two-sided p-value based on cLDA model.|cLDA model|||||1.67|-5.20|0.3138
91495110|NCT03765918|182862055|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.28||||0.1763|TWO_SIDED|95.0|-8.05|1.48||Two-sided p-value based on cLDA model.|cLDA model|||||1.48|-8.05|0.1763
91495111|NCT03765918|182862056|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.18||||0.6882|TWO_SIDED|95.0|-6.95|4.59||Two-sided p-value based on cLDA model.|cLDA model|||||4.59|-6.95|0.6882
91702375|NCT00772005|183299671|SUPERIORITY_OR_OTHER|||||||0.8335||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8335
91529699|NCT00962585|182935812|SUPERIORITY_OR_OTHER|||||||0.573||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model (Analysis of covariance): Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.~The ANCOVA procedure was used to test the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp where μ1 and μp denote the mean frequency of MSVS (at Week 4 in case of primary efficacy endpoint), adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively."||||0.5730
91529700|NCT00962585|182935812|SUPERIORITY_OR_OTHER||LS means difference|1.13|||>|0.05|TWO_SIDED|95.0|-10.06|12.32|||Pair-wise comparisons|||||12.32|-10.06|>0.05
91529701|NCT00962585|182935812|SUPERIORITY_OR_OTHER||LS means difference|6.98|||>|0.05|TWO_SIDED|95.0|-3.87|17.84|||Pair-wise comparisons|||||17.84|-3.87|>0.05
91529702|NCT00962585|182935812|SUPERIORITY_OR_OTHER||LS means difference|0.94|||>|0.05|TWO_SIDED|95.0|-10.16|12.04|||Pair-wise comparisons|||||12.04|-10.16|>0.05
91529703|NCT00962585|182935813|SUPERIORITY_OR_OTHER|||||||0.7364||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model: Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7~1-week period = remaining days of the period since the last visit (i.e. period following first 7 days, as per CRF)"||||0.7364
91529704|NCT00962585|182935813|SUPERIORITY_OR_OTHER||LS means difference|-0.19|||>|0.05|TWO_SIDED|95.0|-12.38|12.01|||Pair-wise comparisons|||||12.01|-12.38|>0.05
91529705|NCT00962585|182935813|SUPERIORITY_OR_OTHER||LS means difference|4.77|||>|0.05|TWO_SIDED|95.0|-6.94|16.48|||Pair-wise comparisons|||||16.48|-6.94|>0.05
91529706|NCT00962585|182935813|SUPERIORITY_OR_OTHER||LS means difference|-1.63|||>|0.05|TWO_SIDED|95.0|-13.41|10.15|||Pair-wise comparisons|||||10.15|-13.41|>0.05
91529707|NCT00962585|182935814|SUPERIORITY_OR_OTHER|||||||0.1217||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1 and 2.|Repeated measures ANCOVA|"Mixed Model: MSVS = Baseline (MSVS) + Treatment + Site + Weeks + Treatment x Weeks~Difference Between Means: S-equol treatment group - Placebo"||\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.||||0.1217
91529708|NCT00962585|182935814|SUPERIORITY_OR_OTHER||LS means difference|-3.77|||>|0.05||95.0|-12.69|5.16|||Pair-wise comparisons|||Week 1, Treatment Effect||5.16|-12.69|>0.05
91529709|NCT00962585|182935814|SUPERIORITY_OR_OTHER||LS means difference|9.69|||<|0.05|TWO_SIDED|95.0|0.79|18.6|||Pair-wise comparisons|||Week 1, Treatment Effect||18.60|0.79|<0.05
91529710|NCT00962585|182935814|SUPERIORITY_OR_OTHER||LS means difference|1.31|||>|0.05|TWO_SIDED|95.0|-7.73|10.36|||Pair-wise comparisons|||Week 1, Treatment Effect||10.36|-7.73|>0.05
91529711|NCT00962585|182935814|SUPERIORITY_OR_OTHER||LS means difference|-6.7|||>|0.05|TWO_SIDED|95.0|-18.36|4.96|||Pair-wise comparisons|||Week 2, Treatment Effect||4.96|-18.36|>0.05
91529712|NCT00962585|182935814|SUPERIORITY_OR_OTHER||LS means difference|3.56|||>|0.05|TWO_SIDED|95.0|-8.01|15.14|||Pair-wise comparisons|||Week 2, Treatment Effect||15.14|-8.01|>0.05
91529713|NCT00962585|182935814|SUPERIORITY_OR_OTHER||LS means difference|0.91|||>|0.05|TWO_SIDED|95.0|-10.77|12.58|||Pair-wise comparisons|||Week 2, Treatment Effect||12.58|-10.77|>0.05
91529714|NCT00962585|182935815|SUPERIORITY_OR_OTHER|||||||0.1609||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1, 2 and 4.|Repeated measures ANCOVA|Mixed Model: Severity of VMS = Baseline (severity of VMS) + Treatment + Site + Weeks + Treatment x Weeks||Severity of VMS per week at each protocol visits = (Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7, where severity of vasomotor symptoms are scored as: 1 = mild, 2 = moderate and 3 = severe.||||0.1609
91529715|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|-6.34|||>|0.05|TWO_SIDED|95.0|-26.41|13.73|||Pair-wise comparisons|||Week 1, Treatment Effect||13.73|-26.41|>0.05
91529716|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|25.67|||<|0.05|TWO_SIDED|95.0|5.64|45.69|||Pair-wise comparisons|||Week 1, Treatment Effect||45.69|5.64|<0.05
91529717|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|2.09|||>|0.05|TWO_SIDED|95.0|-18.21|22.39|||Pair-wise comparisons|||Week 1, Treatment Effect||22.39|-18.21|>0.05
91529718|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|-16.14|||>|0.05|TWO_SIDED|95.0|-43.29|11.01|||Pair-wise comparisons|||Week 2, Treatment Effect||11.01|-43.29|>0.05
91529719|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|8.73|||>|0.05|TWO_SIDED|95.0|-18.19|35.65|||Pair-wise comparisons|||Week 2, Treatment Effect||35.65|-18.19|>0.05
91529720|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|-0.65|||>|0.05|TWO_SIDED|95.0|-27.8|26.5|||Pair-wise comparisons|||Week 2, Treatment Effect||26.50|-27.80|>0.05
91529721|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|-1.69|||>|0.05|TWO_SIDED|95.0|-28.68|25.3|||Pair-wise comparisons|||Week 4, Treatment Effect||25.30|-28.68|>0.05
91529722|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|16.15|||>|0.05|TWO_SIDED|95.0|-10.4|42.71|||Pair-wise comparisons|||Week 4, Treatment Effect||42.71|-10.40|>0.05
91529723|NCT00962585|182935815|SUPERIORITY_OR_OTHER||LS means difference|-1.29|||>|0.05|TWO_SIDED|95.0|-28.18|25.6|||Pair-wise comparisons|||Week 4, Treatment Effect||25.60|-28.18|>0.05
91529724|NCT00962585|182935816|SUPERIORITY_OR_OTHER|||||||0.2211||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal pH) = Baseline (Vaginal pH) + Treatment + Site + Weeks + Treatment x Weeks||||||0.2211
91529725|NCT00962585|182935816|SUPERIORITY_OR_OTHER||LS means difference|-0.21|||>|0.05|TWO_SIDED|95.0|-0.53|0.12|||Pair-wise comparisons|||Week 2, Treatment Effect||0.12|-0.53|>0.05
91529726|NCT00962585|182935816|SUPERIORITY_OR_OTHER||LS means difference|-0.23|||>|0.05|TWO_SIDED|95.0|-0.55|0.09|||Pair-wise comparisons|||Week 2, Treatment Effect||0.09|-0.55|>0.05
91529727|NCT00962585|182935816|SUPERIORITY_OR_OTHER||LS means difference|0.03|||>|0.05|TWO_SIDED|95.0|-0.28|0.35|||Pair-wise comparisons|||Week 2, Treatment Effect||0.35|-0.28|>0.05
91529728|NCT00962585|182935816|SUPERIORITY_OR_OTHER||LS means difference|-0.26|||>|0.05|TWO_SIDED|95.0|-0.54|0.02|||Pair-wise comparisons|||Week 4, Treatment Effect||0.02|-0.54|>0.05
91529729|NCT00962585|182935816|SUPERIORITY_OR_OTHER||LS means difference|-0.13|||>|0.05|TWO_SIDED|95.0|-0.4|0.14|||Pair-wise comparisons|||Week 4, Treatment Effect||0.14|-0.40|>0.05
91529730|NCT00962585|182935816|SUPERIORITY_OR_OTHER||LS means difference|-0.24|||>|0.05|TWO_SIDED|95.0|-0.51|0.03|||Pair-wise comparisons|||Week 4, Treatment Effect||0.03|-0.51|>0.05
91529731|NCT00962585|182935817|SUPERIORITY_OR_OTHER|||||||0.6375||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal Maturation Index) = Baseline (Vaginal Maturation Index) + Treatment + Site + Weeks + Treatment x Weeks||Vaginal maturation index = 0.2 x (% parabasal cells) + 0.6 x(% intermediate cells) + 1.0 x (% superficial cells)||||0.6375
91529732|NCT00962585|182935817|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.57|6.42|||Pair-wise comparisons|||Week 2, Treatment Effect||6.42|-9.57|>0.05
91529733|NCT00962585|182935817|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.63|6.46|||Pair-wise comparisons|||Week 2, Treatment Effect||6.46|-9.63|>0.05
91529734|NCT00962585|182935817|SUPERIORITY_OR_OTHER||LS means difference|-1.59|||>|0.05|TWO_SIDED|95.0|-9.66|6.47|||Pair-wise comparisons|||Week 2, Treatment Effect||6.47|-9.66|>0.05
91529735|NCT00962585|182935817|SUPERIORITY_OR_OTHER||LS means difference|-0.31|||>|0.05|TWO_SIDED|95.0|-6.73|6.11|||Pair-wise comparisons|||Week 4, Treatment Effect||6.11|-6.73|>0.05
91529736|NCT00962585|182935817|SUPERIORITY_OR_OTHER||LS means difference|-6.14|||>|0.05|TWO_SIDED|95.0|-12.36|0.07|||Pair-wise comparisons|||Week 4, Treatment Effect||0.07|-12.36|>0.05
91529737|NCT00962585|182935817|SUPERIORITY_OR_OTHER||LS means difference|-2.88|||>|0.05|TWO_SIDED|95.0|-9.05|3.28|||Pair-wise comparisons|||Week 4, Treatment Effect||3.28|-9.05|>0.05
91529738|NCT00962585|182935818|SUPERIORITY_OR_OTHER|||||||0.0681||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Estradiol) = Baseline (Estradiol) + Treatment + Site + Weeks + Treatment x Weeks||||||0.0681
91529739|NCT00962585|182935818|SUPERIORITY_OR_OTHER||LS means difference|35.32|||>|0.05|TWO_SIDED|95.0|1.75|68.9|||Pair-wise comparisons|||Week 2, Treatment Effect||68.90|1.75|>0.05
91733691|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|5.2||||0.006|TWO_SIDED|95.0|1.5|8.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||8.9|1.5|0.006
91529740|NCT00962585|182935818|SUPERIORITY_OR_OTHER||LS means difference|3.61|||>|0.05|TWO_SIDED|95.0|-29.12|36.34|||Pair-wise comparisons|||Week 2, Treatment Effect||36.34|-29.12|>0.05
91529741|NCT00962585|182935818|SUPERIORITY_OR_OTHER||LS means difference|-4.58|||>|0.05|TWO_SIDED|95.0|-37.39|28.23|||Pair-wise comparisons|||Week 2, Treatment Effect||28.23|-37.39|>0.05
91529742|NCT00962585|182935818|SUPERIORITY_OR_OTHER||LS means difference|22.12|||>|0.05|TWO_SIDED|95.0|-23.56|67.8|||Pair-wise comparisons|||Week 4, Treatment Effect||67.80|-23.56|>0.05
91529743|NCT00962585|182935818|SUPERIORITY_OR_OTHER||LS means difference|7.8|||>|0.05|TWO_SIDED|95.0|-36.7|52.29|||Pair-wise comparisons|||Week 4, Treatment Effect||52.29|-36.70|>0.05
91529744|NCT00962585|182935818|SUPERIORITY_OR_OTHER||LS means difference|-22.74|||>|0.05|TWO_SIDED|95.0|-67.44|21.96|||Pair-wise comparisons|||Week 4, Treatment Effect||21.96|-67.44|>0.05
91529745|NCT00962585|182935822|SUPERIORITY_OR_OTHER|||||||0.0475||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0475
91529746|NCT00962585|182935822|SUPERIORITY_OR_OTHER|||||||0.0258||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0258
91529747|NCT00962585|182935822|SUPERIORITY_OR_OTHER|||||||0.0281||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0281
91529748|NCT00962585|182935822|SUPERIORITY_OR_OTHER|||||||0.0645||95.0|||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.0645
91529749|NCT00962585|182935823|SUPERIORITY_OR_OTHER|||||||0.0097||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0097
91529750|NCT00962585|182935824|SUPERIORITY_OR_OTHER|||||||0.4352||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.4352
91529751|NCT00962585|182935824|SUPERIORITY_OR_OTHER|||||||0.26||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.2600
91529752|NCT00962585|182935824|SUPERIORITY_OR_OTHER|||||||0.7037||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.7037
91529753|NCT00962585|182935824|SUPERIORITY_OR_OTHER|||||||0.7155|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.7155
91529754|NCT00962585|182935825|SUPERIORITY_OR_OTHER|||||||0.0381||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0381
91733692|NCT00806585|183361526|SUPERIORITY_OR_OTHER||Difference in least squares means|6.7|||<|0.001|TWO_SIDED|95.0|3.0|10.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||10.4|3.0|<0.001
91529755|NCT05454449|182935830|OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
91529756|NCT05454449|182935831|OTHER|||||||0.009|||||||t-test, 2 sided|||||||0.009
91529757|NCT05454449|182935832|OTHER|||||||0.082|||||||t-test, 2 sided|||||||0.082
91529758|NCT05454449|182935833|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
91529759|NCT05454449|182935834|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
91529760|NCT05454449|182935835|OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
91529761|NCT05454449|182935836|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
91529762|NCT01950273|182935875|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) mean ratio|89.53|||||TWO_SIDED|90.0|75.42|106.29|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||106.29|75.42|
91529763|NCT01950273|182935876|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|94.6||||||90.0|85.04|105.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.23|85.04|
91529764|NCT01950273|182935877|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|89.94|||||TWO_SIDED|90.0|77.62|104.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||104.23|77.62|
91529765|NCT01950273|182935878|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|97.65|||||TWO_SIDED|90.0|90.45|105.42|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.42|90.45|
91529766|NCT01950273|182935879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|249.2|||||TWO_SIDED|90.0|-210.6|709.0|||||Mean difference calculated as BI 695500-Rituximab (MabThera®).|||709|-210.6|
91529767|NCT01950273|182935881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||||TWO_SIDED|95.0|-29.4|11.1|||||Difference in ORR calculated as ORR (BI695500) - ORR (MabThera®). The confidence interval represented is 95% difference in proportions.|||11.1|-29.4|
91529768|NCT01950273|182935882|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-18.0|22.1|||||Difference in TEAE incidence calculated as BI695500 - TEAE incidence (MabThera®). The confidence interval represented is 95% difference in proportions.|||22.1|-18.0|
91529769|NCT00179010|182935899|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANOVA|||||||0.854
91529770|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|Mixed Model for Repeated Measures (MMRM)|||||||<0.0001
91529771|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
91529772|NCT03748979|182935908|SUPERIORITY|||||||0.0002||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||0.0002
91529773|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
91529774|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
91529775|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
91529776|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
91529777|NCT03748979|182935908|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
91529778|NCT03249376|182935909|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.34|-2.83|||Mixed Effects Model for Repeated Measure|||||-2.83|-6.34|<0.0001
91529779|NCT03249376|182935910|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.37|-0.51|||Mixed Effects Model for Repeated Measure|||||-0.51|-1.37|<0.0001
91529780|NCT03249376|182935911|SUPERIORITY||Least Squares Mean Difference|4.6||||0.005|TWO_SIDED|95.0|1.42|7.69|||ANCOVA|||||7.69|1.42|0.005
91529781|NCT02694640|182935925|SUPERIORITY|The study was powered to detect significant between-group differences in mean min/week MVPA at follow-up.|effect size|0.11|||<|0.05|TWO_SIDED|||||No adjustment for multiple comparisons was made|Regression, Linear||Effect size refers to between-group difference at follow-up.|A series of longitudinal mixed effects models with subject-specific intercepts were used to examine between-group differences in mean min/week of self reported moderate-to-vigorous physical activity (MVPA).||||<.05
91529782|NCT02694640|182935926|SUPERIORITY||effect size|0.09|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
91529783|NCT00432679|182935936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.01|-0.61||Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)|ANCOVA|||||-0.61|-1.01|<0.001
91529784|NCT00432679|182935937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.1|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.1|-12.1|||Unpaired t-test|||||-12.1|-32.1|<0.001
91529785|NCT00432679|182935938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.718|STANDARD_ERROR_OF_MEAN|0.8102||0.377|TWO_SIDED|95.0|-0.883|2.319|||Unpaired t-test|||||2.319|-0.883|0.377
91529786|NCT00432679|182935939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.094||0.33|TWO_SIDED|95.0|-6.18|2.09|||Unpaired t-test|||||2.09|-6.18|0.330
91529787|NCT00432679|182935940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.473||0.983|TWO_SIDED|95.0|-0.945|0.925|||Unpaired t-test|||||0.925|-0.945|0.983
91529788|NCT00432679|182935941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.556||0.022|TWO_SIDED|95.0|1.191|15.248|||Unpaired t-test|||||15.248|1.191|0.022
91529789|NCT00432679|182935942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.21|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|6.52|9.91|||Unpaired t-test|||||9.91|6.52|<0.001
91733693|NCT00806585|183361527|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.4||||0.684|TWO_SIDED|95.0|-8.3|5.5|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.5|-8.3|0.684
91733694|NCT00806585|183361527|SUPERIORITY_OR_OTHER||Difference in least squares means|1.8||||0.597|TWO_SIDED|95.0|-5.0|8.7|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||8.7|-5.0|0.597
91733695|NCT00806585|183361527|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.793|TWO_SIDED|95.0|-7.6|5.8|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.8|-7.6|0.793
91733696|NCT00806585|183361527|SUPERIORITY_OR_OTHER||Difference in least squares means|0.8||||0.854|TWO_SIDED|95.0|-7.6|9.2|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||9.2|-7.6|0.854
91733697|NCT00806585|183361528|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.9||||0.006|TWO_SIDED|95.0|-3.2|-0.5|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.5|-3.2|0.006
91495112|NCT03765918|182862057|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.52||||0.3103|TWO_SIDED|95.0|-7.39|2.35||Two-sided p-value based on cLDA model.|cLDA model|||||2.35|-7.39|0.3103
91495113|NCT03765918|182862058|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.48||||0.8475|TWO_SIDED|95.0|-5.41|4.45||Two-sided p-value based on cLDA model.|cLDA model|||||4.45|-5.41|0.8475
91495114|NCT03765918|182862059|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.42||||0.8881|TWO_SIDED|95.0|-6.36|5.51||Two-sided p-value based on cLDA model.|cLDA model|||||5.51|-6.36|0.8881
91529790|NCT00432679|182935943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.355||0.069|TWO_SIDED|95.0|-0.05|1.35|||Unpaired t-test||Comparison of leptin.|||1.35|-0.05|0.069
91733698|NCT00806585|183361528|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.004|TWO_SIDED|95.0|-3.3|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.3|0.004
91733699|NCT00806585|183361528|SUPERIORITY_OR_OTHER||Diffference in least squares means|-1.3||||0.066|TWO_SIDED|95.0|-2.6|0.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.1|-2.6|0.066
91733700|NCT00806585|183361528|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.7|0.008
91733701|NCT00806585|183361529|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.18||||0.152|TWO_SIDED|95.0|-0.44|0.07|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.07|-0.44|0.152
91733702|NCT00806585|183361529|SUPERIORITY_OR_OTHER||Difference in least sqaures means|-0.28||||0.035|TWO_SIDED|95.0|-0.54|-0.02|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.02|-0.54|0.035
91495115|NCT03765918|182862060|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.22||||0.9307|TWO_SIDED|95.0|-5.22|4.78||Two-sided p-value based on cLDA model.|cLDA model|||||4.78|-5.22|0.9307
91495116|NCT03765918|182862067|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|1.3||||0.5752|TWO_SIDED|95.0|-3.25|5.85||Two-sided p-value based on cLDA model.|cLDA model|||||5.85|-3.25|0.5752
91529791|NCT00432679|182935943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-888.8|STANDARD_ERROR_OF_MEAN|803.96||0.271|TWO_SIDED|95.0|-2477.7|700.1|||Unpaired t-test||Comparison of hs-CRP|||700.1|-2477.7|0.271
91733703|NCT00806585|183361529|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.095|TWO_SIDED|95.0|-0.48|0.04|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.04|-0.48|0.095
91733704|NCT00806585|183361529|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.32||||0.045|TWO_SIDED|95.0|-0.63|-0.01|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.01|-0.63|0.045
91733705|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0129|TWO_SIDED|95.0|2.41|14.72||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Left eye||14.72|2.41|0.0129
91733706|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|7.58||||0.0077|TWO_SIDED|95.0|1.7|13.45||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Right eye||13.45|1.70|0.0077
91733707|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|3.99||||0.1589|TWO_SIDED|95.0|-1.64|9.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Left eye||9.62|-1.64|0.1589
91733708|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.3167|TWO_SIDED|95.0|-2.78|8.35||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Right eye||8.35|-2.78|0.3167
91733709|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.5243|TWO_SIDED|95.0|-7.64|3.96||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Left eye||3.96|-7.64|0.5243
91733710|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.6714|TWO_SIDED|95.0|-4.45|6.82||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Right eye||6.82|-4.45|0.6714
91733711|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.0828|TWO_SIDED|95.0|-8.31|0.53||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Left eye||0.53|-8.31|0.0828
91733712|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.7823|TWO_SIDED|95.0|-4.77|3.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Right eye||3.62|-4.77|0.7823
91733713|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.0432|TWO_SIDED|95.0|0.16|9.7||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Left eye||9.70|0.16|0.0432
91733714|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|6.35||||0.0088|TWO_SIDED|95.0|1.7|11.0||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Right eye||11.00|1.70|0.0088
91733715|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|9.28||||0.0013|TWO_SIDED|95.0|3.9|14.66||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Left eye||14.66|3.90|0.0013
91733716|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|5.31||||0.00629|TWO_SIDED|95.0|-0.3|10.92||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Right eye||10.92|-0.30|0.00629
91733717|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|9.92||||0.002|TWO_SIDED|95.0|3.89|15.95||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Left eye||15.95|3.89|0.0020
91733718|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|7.95||||0.0111|TWO_SIDED|95.0|1.93|13.97||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Right eye||13.97|1.93|0.0111
91733719|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|31.67||||0.0448|TWO_SIDED|95.0|0.78|62.56||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Left eye||62.56|0.78|0.0448
91733720|NCT02507934|183361530|SUPERIORITY||Mean Difference (Final Values)|26.36||||0.0834|TWO_SIDED|95.0|-3.66|56.37||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Right eye||56.37|-3.66|0.0834
91733721|NCT02507934|183361532|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.2317|TWO_SIDED|95.0|-0.14|0.57|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 7 ±1||0.57|-0.14|0.2317
91733722|NCT02507934|183361532|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.6017|TWO_SIDED|95.0|-0.7|0.41|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 7 ±1||0.41|-0.70|0.6017
91733723|NCT02507934|183361532|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.0232|TWO_SIDED|95.0|0.11|1.36|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 14 ±1||1.36|0.11|0.0232
91733724|NCT02507934|183361532|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0398|TWO_SIDED|95.0|0.03|1.17|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 14 ±1||1.17|0.03|0.0398
91733725|NCT02507934|183361532|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.0038|TWO_SIDED|95.0|0.36|1.74|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 21 ±1||1.74|0.36|0.0038
91733726|NCT02507934|183361532|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.0135|TWO_SIDED|95.0|0.17|1.33|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - right eye||1.33|0.17|0.0135
91733727|NCT02507934|183361533|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.3442|TWO_SIDED|95.0|-0.66|1.83|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 7±1||1.83|-0.66|0.3442
91733728|NCT02507934|183361533|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.772|TWO_SIDED|95.0|-1.99|1.49|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 7±1||1.49|-1.99|0.7720
91733729|NCT02507934|183361533|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9725|TWO_SIDED|95.0|-1.49|1.44|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 14±1||1.44|-1.49|0.9725
91733730|NCT02507934|183361533|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.2111|TWO_SIDED|95.0|-3.54|0.81|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 14±1||0.81|-3.54|0.2111
91733731|NCT02507934|183361533|SUPERIORITY||Median Difference (Final Values)|-1.1||||0.2629|TWO_SIDED|90.0|-3.06|0.86|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 21±1||0.86|-3.06|0.2629
91733732|NCT02507934|183361533|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.2862|TWO_SIDED|95.0|-3.6|1.1|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - 21±1||1.10|-3.60|0.2862
91733733|NCT02507934|183361534|SUPERIORITY||Mean Difference (Final Values)|11.24||||0.2075|TWO_SIDED|95.0|-6.66|29.14|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 7±1||29.14|-6.66|0.2075
91733734|NCT02507934|183361534|SUPERIORITY||Mean Difference (Final Values)|18.16||||0.0435|TWO_SIDED|95.0|0.57|35.76|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 14±1||35.76|0.57|0.0435
91733735|NCT02507934|183361534|SUPERIORITY||Mean Difference (Final Values)|23.58||||0.0133|TWO_SIDED|95.0|5.24|41.93|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 21±1||41.93|5.24|0.0133
91733736|NCT02507934|183361535|SUPERIORITY||Mean Difference (Final Values)|4.36||||0.613|TWO_SIDED|95.0|-12.98|21.69|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 7±1||21.69|-12.98|0.6130
91733737|NCT02507934|183361535|SUPERIORITY||Mean Difference (Final Values)|12.7||||0.1047|TWO_SIDED|95.0|-2.78|28.18|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 14±1||28.18|-2.78|0.1047
91733738|NCT02507934|183361535|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.1108|TWO_SIDED|95.0|-3.24|30.04|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 21±1||30.04|-3.24|0.1108
91733739|NCT02507934|183361536|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.498|TWO_SIDED|95.0|-0.4|0.81|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 7±1||0.81|-0.40|0.4980
91529792|NCT00432679|182935944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, decrease by 0.7%|||54.1|27.1|
91529793|NCT00432679|182935944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|-0.3|13.8|||||Comparison of HbA1c, fell below 6.5%|||13.8|-0.3|
91529794|NCT00432679|182935944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, satisfied either 1 or 2|||54.1|27.1|
91529795|NCT00432679|182935944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.5|36.6|||||Comparison of FPG, decrease of 30 milligrams per decilliter|||36.6|9.5|
91733740|NCT02507934|183361536|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.1986|TWO_SIDED|95.0|-0.18|0.83|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 7±1||0.83|-0.18|0.1986
91733741|NCT02507934|183361536|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4067|TWO_SIDED|95.0|-0.9|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 14±1||0.37|-0.90|0.4067
91733742|NCT02507934|183361536|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.5256|TWO_SIDED|95.0|-0.81|0.42|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 14±1||0.42|-0.81|0.5256
91733743|NCT02507934|183361536|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.1471|TWO_SIDED|95.0|-1.12|0.17|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 21±1||0.17|-1.12|0.1471
91733744|NCT02507934|183361536|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.2455|TWO_SIDED|95.0|-0.96|0.25|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 21±1||0.25|-0.96|0.2455
91733745|NCT02507934|183361537|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.4233|TWO_SIDED|95.0|-1.98|0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 7±1||0.85|-1.98|0.4233
91733746|NCT02507934|183361537|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.6335|TWO_SIDED|95.0|-1.04|1.69|||Student t-test for unpaired data|||T test p-value - Right eye - Day 7±1||1.69|-1.04|0.6335
91733747|NCT02507934|183361537|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.0103|TWO_SIDED|95.0|-3.56|-0.51|||Student t-test for unpaired data|||T test p-value - Left eye - Day 14±1||-0.51|-3.56|0.0103
91733748|NCT02507934|183361537|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.1006|TWO_SIDED|95.0|-2.95|0.27|||Student t-test for unpaired data|||T test p-value - Right eye - Day 14±1||0.27|-2.95|0.1006
91733749|NCT02507934|183361537|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0041|TWO_SIDED|95.0|-4.15|-0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 21±1||-0.85|-4.15|0.0041
91733750|NCT02507934|183361537|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.0429|TWO_SIDED|95.0|-3.67|-0.06|||Student t-test for unpaired data|||T test p-value - Right eye - Day 21±1||-0.06|-3.67|0.0429
91733751|NCT02507934|183361538|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2338|TWO_SIDED|95.0|-0.75|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 7±1||0.19|-0.75|0.2338
91733752|NCT02507934|183361538|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.3081|TWO_SIDED|95.0|-0.58|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 7±1||0.19|-0.58|0.3081
91733753|NCT02507934|183361538|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.4287|TWO_SIDED|95.0|-2.57|5.74|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 14±1||5.74|-2.57|0.4287
91733754|NCT02507934|183361538|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.5765|TWO_SIDED|95.0|-3.14|5.44|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 14±1||5.44|-3.14|0.5765
91733755|NCT02507934|183361538|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.0259|TWO_SIDED|95.0|-2.18|-0.15|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 21±1||-0.15|-2.18|0.0259
91733756|NCT02507934|183361538|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.1496|TWO_SIDED|95.0|-2.23|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 21±1||0.37|-2.23|0.1496
91733757|NCT02507934|183361539|SUPERIORITY|||||||0.2342|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 7±1||||0.2342
91733758|NCT02507934|183361539|SUPERIORITY|||||||0.8874|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 7±1||||0.8874
91733759|NCT02507934|183361539|SUPERIORITY|||||||0.0504|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 7±1||||0.0504
91733760|NCT02507934|183361539|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 7±1||||0.0814
91733761|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 7±1||||1.0000
91733762|NCT02507934|183361539|SUPERIORITY|||||||0.3855|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 7±1||||0.3855
91733763|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 7±1||||1.0000
91733764|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 7±1||||1.0000
91733765|NCT02507934|183361539|SUPERIORITY|||||||0.4754|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 7±1||||0.4754
91733766|NCT02507934|183361539|SUPERIORITY|||||||0.2914|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 7±1||||0.2914
91495117|NCT03765918|182862068|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.98||||0.7196|TWO_SIDED|95.0|-4.38|6.34||Two-sided p-value based on cLDA model.|cLDA model|||||6.34|-4.38|0.7196
91495118|NCT03765918|182862069|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.74||||0.7522|TWO_SIDED|95.0|-3.88|5.37||Two-sided p-value based on cLDA model.|cLDA model|||||5.37|-3.88|0.7522
91495119|NCT03765918|182862070|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.24||||0.9255|TWO_SIDED|95.0|-5.3|4.82||Two-sided p-value based on cLDA model.|cLDA model|||||4.82|-5.30|0.9255
91495120|NCT03765918|182862071|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|2.22||||0.4926|TWO_SIDED|95.0|-4.15|8.6||Two-sided p-value based on cLDA model.|cLDA model|||||8.60|-4.15|0.4926
91529796|NCT00432679|182935944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.9|||||TWO_SIDED|95.0|-5.1|18.9|||||Comparison of FPG, fell below 126 milligrams per deciliter|||18.9|-5.1|
91529797|NCT00432679|182935944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|5.6|35.3|||||Comparison of FPG, satisfied either 1 or 2|||35.3|5.6|
91529798|NCT00906503|182935945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|STANDARD_DEVIATION|1.6|||TWO_SIDED|95.0|0.06|31.1||||||||31.1|0.06|
91529799|NCT03405662|182935946|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
91529800|NCT03405662|182935947|SUPERIORITY|||||||0.29|||||||non-parametric Kolmogorov-Smirnov test|||||||0.29
91529801|NCT03405662|182935948|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
91529802|NCT03405662|182935949|SUPERIORITY|||||||0.23|||||||non-parametric Kolmogorov-Smirnov test|||||||0.23
91529803|NCT03405662|182935950|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
91529804|NCT03405662|182935951|SUPERIORITY|||||||0.13|||||||non-parametric Kolmogorov-Smirnov test|||||||0.13
91529805|NCT03405662|182935952|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
91529806|NCT03405662|182935953|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
91529807|NCT03405662|182935954|SUPERIORITY|||||||0.86|||||||non-parametric Kolmogorov-Smirnov test|||||||0.86
91529808|NCT03405662|182935955|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
91529809|NCT01177813|182935960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.9|-0.57||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.57|-0.90|<0.0001
91529810|NCT01177813|182935960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-1.01|-0.69||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.69|-1.01|<0.0001
91529811|NCT01177813|182935961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.48|-1.38||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.38|-2.48|<0.0001
91529812|NCT01177813|182935961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.7|-1.6||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.60|-2.70|<0.0001
91529813|NCT01177813|182935962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.0231|TWO_SIDED|97.5|-5.2|0.0||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for Systolic Blood Pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||0.0|-5.2|0.0231
91529814|NCT01177813|182935962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0028|TWO_SIDED|97.5|-6.0|-0.9||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for Systolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||-0.9|-6.0|0.0028
91529815|NCT01177813|182935962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.3987|TWO_SIDED|97.5|-2.1|0.9||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.9|-2.1|0.3987
91529816|NCT01177813|182935962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0296|TWO_SIDED|97.5|-3.0|0.0||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.0|-3.0|0.0296
91529817|NCT00581256|182935964|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||A Perfusion Defect (PD) increase of greater than 5% for a 2.5 SD threshold was considered significant.||||0.6
91529818|NCT00581256|182935964|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||A PD increase of greater than 10% for a 1.5 SD threshold was considered significant.||||0.46
91733767|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 7±1||||1.0000
91733768|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 7±1||||1.0000
91733769|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 7±1||||1.0000
91733770|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 7±1||||1.0000
91733771|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 7±1||||1.0000
91733772|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 7±1||||1.0000
91733773|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 7±1||||1.0000
91733774|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 7±1||||1.0000
91495121|NCT03765918|182862072|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.99||||0.7087|TWO_SIDED|95.0|-4.23|6.21||Two-sided p-value based on cLDA model.|cLDA model|||||6.21|-4.23|0.7087
91733775|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 7±1||||1.0000
91733776|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 7±1||||1.0000
91733777|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 7±1||||1.0000
91733778|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 7±1||||1.0000
91733779|NCT02507934|183361539|SUPERIORITY|||||||0.2429|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 14±1||||0.2429
91733780|NCT02507934|183361539|SUPERIORITY|||||||0.5707|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 14±1||||0.5707
91733781|NCT02507934|183361539|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 14±1||||0.0092
91733782|NCT02507934|183361539|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 14±1||||0.0039
91733783|NCT02507934|183361539|SUPERIORITY|||||||0.2882|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 14±1||||0.2882
91733784|NCT02507934|183361539|SUPERIORITY|||||||0.4017|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 14±1||||0.4017
91733785|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 14±1||||1.0000
91733786|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 14±1||||1.0000
91733787|NCT02507934|183361539|SUPERIORITY|||||||0.0731|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 14±1||||0.0731
91733788|NCT02507934|183361539|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 14±1||||0.0020
91733789|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 14±1||||1.0000
91733790|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 14±1||||1.0000
91733791|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 14±1||||1.0000
91733792|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 14±1||||1.0000
91733793|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 14±1||||1.0000
91733794|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 14±1||||1.0000
91495122|NCT03765918|182862079|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.75||||0.1654|TWO_SIDED|95.0|-6.65|1.14||Two-sided p-value based on cLDA model.|cLDA model|||||1.14|-6.65|0.1654
91495123|NCT03765918|182862080|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.26||||0.9117|TWO_SIDED|95.0|-4.29|4.8||Two-sided p-value based on cLDA model.|cLDA model|||||4.80|-4.29|0.9117
91495124|NCT03765918|182862081|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.22||||0.2808|TWO_SIDED|95.0|-6.25|1.82||Two-sided p-value based on cLDA model.|cLDA model|||||1.82|-6.25|0.2808
91733795|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 14±1||||1.0000
91733796|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 14±1||||1.0000
91733797|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 14±1||||1.0000
91733798|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 14±1||||1.0000
91733799|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 14±1||||1.0000
91733800|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 14±1||||1.0000
91733801|NCT02507934|183361539|SUPERIORITY|||||||0.1376|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 21±1||||0.1376
91733802|NCT02507934|183361539|SUPERIORITY|||||||0.3252|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 21±1||||0.3252
91733803|NCT02507934|183361539|SUPERIORITY|||||||0.0111|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0111
91733804|NCT02507934|183361539|SUPERIORITY|||||||0.0049|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0049
91733805|NCT02507934|183361539|SUPERIORITY|||||||0.1178|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 21±1||||0.1178
91733806|NCT02507934|183361539|SUPERIORITY|||||||0.9042|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 21±1||||0.9042
91733807|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 21±1||||1.0000
91733808|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 21±1||||1.0000
91733809|NCT02507934|183361539|SUPERIORITY|||||||0.0253|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 21±1||||0.0253
91733810|NCT02507934|183361539|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 21±1||||0.0016
91733811|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 21±1||||1.0000
91733812|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 21±1||||1.0000
91733813|NCT02507934|183361539|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 21±1||||0.3165
91733814|NCT02507934|183361539|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 21±1||||0.3165
91733815|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 21±1||||1.0000
91733816|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 21±1||||1.0000
91733817|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 21±1||||1.0000
91733818|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 21±1||||1.0000
91733819|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 21±1||||1.0000
91733820|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 21±1||||1.0000
91733821|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 21±1||||1.0000
91529819|NCT03220737|182936002|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to co-primary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
91733822|NCT02507934|183361539|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 21±1||||1.0000
91733823|NCT02507934|183361540|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0599|TWO_SIDED|95.0|-0.05|2.29|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 7±1||2.29|-0.05|0.0599
91702376|NCT00772005|183299671|SUPERIORITY_OR_OTHER|||||||0.5674||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5674
91702377|NCT00772005|183299672|SUPERIORITY_OR_OTHER|||||||0.3536||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3536
91702378|NCT00772005|183299672|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1940
91702379|NCT00772005|183299672|SUPERIORITY_OR_OTHER|||||||0.2129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2129
91702380|NCT00772005|183299673|SUPERIORITY_OR_OTHER|||||||0.584||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5840
91702381|NCT00772005|183299673|SUPERIORITY_OR_OTHER|||||||0.6028||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6028
91702382|NCT00772005|183299673|SUPERIORITY_OR_OTHER|||||||0.1426||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1426
91702383|NCT00772005|183299674|SUPERIORITY_OR_OTHER|||||||0.5989||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5989
91702384|NCT00772005|183299674|SUPERIORITY_OR_OTHER|||||||0.7411||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7411
91702385|NCT00772005|183299674|SUPERIORITY_OR_OTHER|||||||0.1566||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1566
91702386|NCT00772005|183299675|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2610
91702387|NCT00772005|183299675|SUPERIORITY_OR_OTHER|||||||0.4457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4457
91702388|NCT00772005|183299675|SUPERIORITY_OR_OTHER|||||||0.1342||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1342
91702389|NCT00772005|183299676|SUPERIORITY_OR_OTHER|||||||0.0974||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0974
91702390|NCT00772005|183299676|SUPERIORITY_OR_OTHER|||||||0.664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6640
91702391|NCT00772005|183299676|SUPERIORITY_OR_OTHER|||||||0.1507||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1507
91702392|NCT00772005|183299677|SUPERIORITY_OR_OTHER|||||||0.7649||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7649
91702393|NCT00772005|183299677|SUPERIORITY_OR_OTHER|||||||0.4866||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4866
91702394|NCT00772005|183299677|SUPERIORITY_OR_OTHER|||||||0.5002||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5002
91495125|NCT03765918|182862082|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.77||||0.1577|TWO_SIDED|95.0|-6.62|1.08||Two-sided p-value based on cLDA model.|cLDA model|||||1.08|-6.62|0.1577
91495126|NCT03765918|182862083|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.81||||0.2485|TWO_SIDED|95.0|-7.59|1.97||Two-sided p-value based on cLDA model.|cLDA model|||||1.97|-7.59|0.2485
91495127|NCT03765918|182862084|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1364|TWO_SIDED|95.0|-7.03|0.96||Two-sided p-value based on cLDA model.|cLDA model|||||0.96|-7.03|0.1364
91495128|NCT03765918|182862090|SUPERIORITY|Hazard ratio (HR) and associated 95% confidence interval (CI) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.73||||0.00411|TWO_SIDED|95.0|0.58|0.92|||Stratified Log Rank|One-sided p-value was based on log-rank test stratified by primary tumor site and tumor stage.||||0.92|0.58|0.00411
91529820|NCT03220737|182936003|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
91529821|NCT03220737|182936004|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
91529822|NCT03220737|182936005|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|5.8|||||TWO_SIDED|96.7|2.4|7.1|||||Newcombe method of determining the difference between two independent binomial distributions|||7.1|2.4|
91529823|NCT03220737|182936006|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.3|||||TWO_SIDED|96.7|-0.3|6.2||||||||6.2|-0.3|
91529824|NCT03220737|182936007|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.5|||||TWO_SIDED|96.7|-1.1|6.4||||||||6.4|-1.1|
91495129|NCT03765918|182862091|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.66||||0.00217|TWO_SIDED|95.0|0.49|0.88|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.88|0.49|0.00217
91495130|NCT03765918|182862092|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.55|0.89|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.89|0.55|0.00140
91495131|NCT00299975|182862111|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
91495132|NCT00299975|182862112|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
91495133|NCT00299975|182862113|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91495134|NCT00299975|182862114|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91529825|NCT03220737|182936008|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91529826|NCT03220737|182936009|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91529827|NCT03220737|182936010|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91529828|NCT03220737|182936014|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91529829|NCT03220737|182936015|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91529830|NCT00684983|182936026|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.89|TWO_SIDED|95.0|0.58|1.89|||Regression, Cox|||Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.||1.89|0.58|.89
91529831|NCT00684983|182936027|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.93|TWO_SIDED|95.0|0.5|3.0|||Log Rank|||||3|0.5|0.93
91529832|NCT00684983|182936028|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.66|TWO_SIDED|95.0|0.53|1.92|||Log Rank|||||1.92|.53|.66
91529833|NCT00684983|182936030|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.26|TWO_SIDED|95.0|0.09|1.53|||Log Rank|||||1.53|.09|.26
91529834|NCT02593032|182936051|SUPERIORITY||Mean Difference (Net)|12.0|||<|0.05|TWO_SIDED|||||This is the calculated p-value, not a threshold.|t-test, 2 sided|||||||<0.05
91529835|NCT01751113|182936081|SUPERIORITY_OR_OTHER||AUC ratio|1.158|||<|0.001|TWO_SIDED|95.0|1.1|1.219|||Mixed Models Analysis|||||1.219|1.100|<0.001
91529836|NCT01751113|182936081|SUPERIORITY_OR_OTHER||AUC ratio|1.288|||<|0.001|TWO_SIDED|95.0|1.224|1.355|||Mixed Models Analysis|||||1.355|1.224|<0.001
91529837|NCT01751113|182936082|SUPERIORITY_OR_OTHER||AUC ratio|0.856|||<|0.001|TWO_SIDED|95.0|0.812|0.902|||Mixed Models Analysis|||||0.902|0.812|<0.001
91529838|NCT01751113|182936082|SUPERIORITY_OR_OTHER||AUC ratio|0.774|||<|0.001|TWO_SIDED|95.0|0.735|0.816|||Mixed Models Analysis|||||0.816|0.735|<0.001
91733824|NCT02507934|183361540|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.3969|TWO_SIDED|95.0|-0.68|1.66|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 7±1||1.66|-0.68|0.3969
91733825|NCT02507934|183361540|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.7225|TWO_SIDED|95.0|-1.29|1.84|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 14±1||1.84|-1.29|0.7225
91733826|NCT02507934|183361540|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.269|TWO_SIDED|95.0|-2.14|0.62|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 14±1||0.62|-2.14|0.2690
91529839|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.181|||<|0.001|TWO_SIDED|95.0|1.104|1.263|||Mixed Models Analysis||Statistical data for 30 minutes|||1.263|1.104|<0.001
91529840|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.303|||<|0.001|TWO_SIDED|95.0|1.219|1.393|||Mixed Models Analysis||Statistical data for 30 minutes|||1.393|1.219|<0.001
91529841|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.175|||<|0.001|TWO_SIDED|95.0|1.099|1.257|||Mixed Models Analysis||Statistical data for 75 minutes|||1.257|1.099|<0.001
91529842|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.34|||<|0.001|TWO_SIDED|95.0|1.253|1.432|||Mixed Models Analysis||Statistical data for 75 minutes|||1.432|1.253|<0.001
91529843|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.151|||<|0.001|TWO_SIDED|95.0|1.076|1.231|||Mixed Models Analysis||Statistical data for 120 minutes|||1.231|1.076|<0.001
91529844|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.301|||<|0.001|TWO_SIDED|95.0|1.217|1.391|||Mixed Models Analysis||Statistical data for 120 minutes|||1.391|1.217|<0.001
91529845|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.141|||<|0.001|TWO_SIDED|95.0|1.067|1.22|||Mixed Models Analysis||Statistical data for 240 minutes|||1.220|1.067|<0.001
91529846|NCT01751113|182936083|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.239|||<|0.001|TWO_SIDED|95.0|1.159|1.325|||Mixed Models Analysis||Statistical data for 240 minutes|||1.325|1.159|<0.001
91529847|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.846|||<|0.001|TWO_SIDED|95.0|0.792|0.905|||Mixed Models Analysis||Statistical data for 30 minutes|||0.905|0.792|<0.001
91529848|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.767|||<|0.001|TWO_SIDED|95.0|0.717|0.819|||Mixed Models Analysis||Statistical data for 30 minutes|||0.819|0.717|<0.001
91529849|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.795|0.909|||Mixed Models Analysis||Statistical data for 75 minutes|||0.909|0.795|<0.001
91529850|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.746|||<|0.001|TWO_SIDED|95.0|0.698|0.798|||Mixed Models Analysis||Statistical data for 75 minutes|||0.798|0.698|<0.001
91529851|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.868|||<|0.001|TWO_SIDED|95.0|0.812|0.928|||Mixed Models Analysis||Statistical data for 120 minutes|||0.928|0.812|<0.001
91529852|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.769|||<|0.001|TWO_SIDED|95.0|0.719|0.822|||Mixed Models Analysis||Statistical data for 120 minutes|||0.822|0.719|<0.001
91529853|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.877|||<|0.001|TWO_SIDED|95.0|0.82|0.938|||Mixed Models Analysis||Statistical data for 240 minutes|||0.938|0.820|<0.001
91529854|NCT01751113|182936084|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.809|||<|0.001|TWO_SIDED|95.0|0.757|0.865|||Mixed Models Analysis||Statistical data for 240 minutes|||0.865|0.757|<0.001
91529855|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.157|||<|0.001|TWO_SIDED|95.0|0.116|0.198|||Mixed Models Analysis||Statistical data for FEV1|||0.198|0.116|<0.001
91529856|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.118|||<|0.001|TWO_SIDED|95.0|0.077|0.159|||Mixed Models Analysis||Statistical data for FEV1|||0.159|0.077|<0.001
91529857|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.082||||0.002|TWO_SIDED|95.0|0.031|0.133|||Mixed Models Analysis||Statistical data for FVC|||0.133|0.031|0.002
91529858|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.135|||<|0.001|TWO_SIDED|95.0|0.084|0.186|||Mixed Models Analysis||Statistical data for FVC|||0.186|0.084|<0.001
91529859|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of IC|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|0.004|0.035
91529860|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of IC|0.064||||0.011|TWO_SIDED|95.0|0.015|0.114|||Mixed Models Analysis||Statistical data for IC|||0.114|0.015|0.011
91529861|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.107||||0.009|TWO_SIDED|95.0|-0.187|-0.028|||Mixed Models Analysis||Statistical data for RV|||-0.028|-0.187|0.009
91495135|NCT00299975|182862115|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between three treatment groups in each time frame.||||||<0.05
91495136|NCT00299975|182862116|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91529862|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.102||||0.012|TWO_SIDED|95.0|-0.18|-0.023|||Mixed Models Analysis||Statistical data for RV|||-0.023|-0.180|0.012
91529863|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.013||||0.632|TWO_SIDED|95.0|-0.066|0.04|||Mixed Models Analysis||Statistical data for TLC|||0.040|-0.066|0.632
91529864|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.014||||0.596|TWO_SIDED|95.0|-0.067|0.038|||Mixed Models Analysis||Statistical data for TLC|||0.038|-0.067|0.596
91529865|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.065||||0.028|TWO_SIDED|95.0|-0.123|-0.007|||Mixed Models Analysis||Statistical data for TGV|||-0.007|-0.123|0.028
91529866|NCT01751113|182936085|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.075||||0.01|TWO_SIDED|95.0|-0.133|-0.018|||Mixed Models Analysis||Statistical data for TGV|||-0.018|-0.133|0.010
91529867|NCT01751113|182936086|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.032|||<|0.001|TWO_SIDED|95.0|0.023|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.023|<0.001
91529868|NCT01751113|182936086|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.017|||<|0.001|TWO_SIDED|95.0|0.008|0.026|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.026|0.008|<0.001
91529869|NCT01751113|182936087|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.835|||<|0.001|TWO_SIDED|95.0|0.77|0.905|||Mixed Models Analysis|||||0.905|0.770|<0.001
91733827|NCT02507934|183361540|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.2344|TWO_SIDED|95.0|-0.53|2.1|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 21±1||2.10|-0.53|0.2344
91733828|NCT02507934|183361540|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.5953|TWO_SIDED|95.0|-1.3|2.24|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye||2.24|-1.30|0.5953
91733829|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.2193|TWO_SIDED|95.0|-0.54|2.11|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 7||2.11|-0.54|0.2193
91495137|NCT00299975|182862117|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91495138|NCT00299975|182862118|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91495139|NCT00299975|182862119|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91495140|NCT00299975|182862120|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91495141|NCT00299975|182862121|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
91529870|NCT01751113|182936087|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.803|||<|0.001|TWO_SIDED|95.0|0.741|0.869|||Mixed Models Analysis|||||0.869|0.741|<0.001
91529871|NCT01751113|182936088|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.108|1.301|||Mixed Models Analysis|||||1.301|1.108|<0.001
91529872|NCT01751113|182936088|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.249|||<|0.001|TWO_SIDED|95.0|1.153|1.352|||Mixed Models Analysis|||||1.352|1.153|<0.001
91529873|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.161|||<|0.001|TWO_SIDED|95.0|0.086|0.236|||Mixed Models Analysis||Statistical data for FEV1|||0.236|0.086|<0.001
91529874|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.103||||0.008|TWO_SIDED|95.0|0.028|0.178|||Mixed Models Analysis||Statistical data for FEV1|||0.178|0.028|0.008
91529875|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.104||||0.051|TWO_SIDED|95.0|0.0|0.209|||Mixed Models Analysis||Statistical data for FVC|||0.209|0.000|0.051
91529876|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.148||||0.006|TWO_SIDED|95.0|0.043|0.253|||Mixed Models Analysis||Statistical data for FVC|||0.253|0.043|0.006
91529877|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.12|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|-0.120|0.890
91529878|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.118|0.103|||Mixed Models Analysis||Statistical data for IC|||0.103|-0.118|0.890
91529879|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.229|||<|0.001|TWO_SIDED|95.0|-0.355|-0.103|||Mixed Models Analysis||Statistical data for RV|||-0.103|-0.355|<0.001
91529880|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.189||||0.003|TWO_SIDED|95.0|-0.314|-0.064|||Mixed Models Analysis||Statistical data for RV|||-0.064|-0.314|0.003
91529881|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.101||||0.055|TWO_SIDED|95.0|-0.204|0.002|||Mixed Models Analysis||Statistical data for TLC|||0.002|-0.204|0.055
91529882|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.105||||0.044|TWO_SIDED|95.0|-0.206|-0.003|||Mixed Models Analysis||Statistical data for TLC|||-0.003|-0.206|0.044
91529883|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.092||||0.085|TWO_SIDED|95.0|-0.197|0.013|||Mixed Models Analysis||Statistical data for TGV|||0.013|-0.197|0.085
91529884|NCT01751113|182936089|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.091||||0.083|TWO_SIDED|95.0|-0.195|0.012|||Mixed Models Analysis||Statistical data for TGV|||0.012|-0.195|0.083
91529885|NCT01751113|182936090|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.027|||<|0.001|TWO_SIDED|95.0|0.014|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.014|<0.001
91529886|NCT01751113|182936090|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.008||||0.223|TWO_SIDED|95.0|-0.005|0.021|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.021|-0.005|0.223
91529887|NCT04147260|182936097|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|90.0|-0.03|0.2|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.20|-0.03|
91733830|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.0024|TWO_SIDED|95.0|0.51|2.18|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 8||2.18|0.51|0.0024
91733831|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.425|TWO_SIDED|95.0|-0.49|1.14|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 9||1.14|-0.49|0.4250
91495142|NCT00299975|182862123|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91495143|NCT00299975|182862124|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91733832|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.1275|TWO_SIDED|95.0|-0.17|1.29|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 10||1.29|-0.17|0.1275
91733833|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.0844|TWO_SIDED|95.0|-0.09|1.42|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 11||1.42|-0.09|0.0844
91733834|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.0238|TWO_SIDED|95.0|0.12|1.6|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 12||1.60|0.12|0.0238
91733835|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.0369|TWO_SIDED|95.0|0.05|1.61|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 13||1.61|0.05|0.0369
91733836|NCT02507934|183361541|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.3496|TWO_SIDED|95.0|-0.61|1.64|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 14||1.64|-0.61|0.3496
91733837|NCT03766399|183361566|OTHER||LS means difference|-0.44||||0.9511|TWO_SIDED|90.0|-12.9|12.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||12.0|-12.9|0.9511
91733838|NCT03766399|183361566|OTHER||LS means difference|-7.87||||0.2849|TWO_SIDED|90.0|-20.3|4.59|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||4.59|-20.3|0.2849
91733839|NCT03766399|183361566|OTHER||LS means difference|-8.31||||0.2595|TWO_SIDED|90.0|-20.8|4.14|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||4.14|-20.8|0.2595
91733840|NCT03766399|183361566|OTHER||LS means difference|-3.04||||0.3604|TWO_SIDED|90.0|-8.6|2.51|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||2.51|-8.60|0.3604
91733841|NCT03766399|183361567|OTHER||LS means difference|-25.4||||0.7544|TWO_SIDED|90.0|-166.0|115.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||115|-166|0.7544
91733842|NCT03766399|183361567|OTHER||LS means difference|-73.3||||0.375|TWO_SIDED|90.0|-214.0|67.6|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||67.6|-214|0.3750
91733843|NCT03766399|183361567|OTHER||LS means difference|-98.7||||0.2377|TWO_SIDED|90.0|-240.0|42.3|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||42.3|-240|0.2377
91733844|NCT03766399|183361567|OTHER||LS means difference|-50.4||||0.1105|TWO_SIDED|90.0|-102.0|1.61|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||1.61|-102|0.1105
91733845|NCT03331354|183361568|SUPERIORITY||Cox Proportional Hazard|1.87|||=|0.016|TWO_SIDED||||||Chi-squared|||||||=.016
91733846|NCT03331354|183361569|SUPERIORITY|||||||0.008|||||||ANCOVA|Initial interview scores were used as control in the ANCOVA||||||.008
91733847|NCT03331354|183361570|SUPERIORITY|||||||0.99|||||||ANCOVA|Change in confidence was evaluated using time one as a covariate.||||||.99
91733848|NCT03331354|183361570|SUPERIORITY|||||||0.99|||||||ANCOVA|Interview scores at enrollment were used as a covariate||||||.99
91733849|NCT03331354|183361571|OTHER||||||<|0.001|||||||Pearson Correlation|||This post-hoc analysis was performed on only the COMPASS group to determine the association between percent of the online system completed and change in interview scores||||<.001
91733850|NCT05889468|183361574|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test, a non-parametric test, was used since the empirical distribution of data did not follow the normality assumption.||This was an intention-to-treat analysis.||||0.49
91733851|NCT05889468|183361575|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Intention-to-treat analysis||||0.32
91733852|NCT05889468|183361577|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
91733853|NCT05889468|183361578|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
91733854|NCT05468918|183361581|OTHER|||||||0.002|||||||ANOVA|||||||0.002
91733855|NCT05468918|183361582|OTHER|||||||0.023|||||||ANOVA|||||||0.023
91733856|NCT01251757|183361640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||<|0.001|TWO_SIDED|95.0|0.011|0.034|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.034|0.011|<.001
91733857|NCT01251757|183361640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||<|0.001|TWO_SIDED|95.0|0.019|0.042|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.042|0.019|<.001
91495144|NCT00299975|182862125|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91759502|NCT02391363|183411753|SUPERIORITY|||||||0.34||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.34
91495145|NCT00299975|182862126|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
91733858|NCT01251757|183361641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.022|TWO_SIDED|95.0|0.002|0.029|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.029|0.002|0.022
91733859|NCT01251757|183361641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|||<|0.001|TWO_SIDED|95.0|0.023|0.05|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.050|0.023|<.001
91733860|NCT01251757|183361642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.002|TWO_SIDED|95.0|1.05|1.24||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.24|1.05|0.002
91733861|NCT01251757|183361642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.001|TWO_SIDED|95.0|1.06|1.26||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.26|1.06|<0.001
91733862|NCT01251757|183361643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.014|TWO_SIDED|95.0|1.02|1.23||adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.23|1.02|0.014
91733863|NCT01251757|183361643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||<|0.001|TWO_SIDED|95.0|1.1|1.32||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.32|1.10|<0.001
91733864|NCT01251757|183361644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.041|TWO_SIDED|95.0|-1.0|0.0||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||0.0|-1.0|.041
91733865|NCT01251757|183361644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.5|0.5||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||.5|-.5|.93
91733866|NCT01251757|183361645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.404|TWO_SIDED|95.0|0.93|1.19||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.19|0.93|.404
91733867|NCT01251757|183361645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.54|TWO_SIDED|95.0|0.85|1.09||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.09|.85|.54
91495146|NCT04380116|182862128|SUPERIORITY|||||||0.366|||||||ANOVA|||||||.366
91495147|NCT01370356|182862204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.0001|TWO_SIDED|95.0|6.09|12.53||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.||12.53|6.09|<0.0001
91495148|NCT01370356|182862205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|4.21|7.61||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||7.61|4.21|<0.0001
91495149|NCT01370356|182862206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.94|5.5||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||5.50|2.94|<0.0001
91495150|NCT01370356|182862207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.03|12.51||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||12.51|6.03|<0.0001
91495151|NCT01370356|182862207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.51|5.98||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||5.98|3.51|<0.0001
91495152|NCT01370356|182862207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.66|||<|0.0001|TWO_SIDED|95.0|2.05|3.44||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||3.44|2.05|<0.0001
91495153|NCT01370356|182862208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|2.05|3.47||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||3.47|2.05|<0.0001
91495154|NCT03129100|182862240|SUPERIORITY||Odds Ratio (OR)|4.35|||<|0.001|TWO_SIDED|95.0|2.03|9.35|||Regression, Logistic|||||9.35|2.03|<0.001
91495155|NCT03129100|182862241|SUPERIORITY||Odds Ratio (OR)|4.28||||0.003|TWO_SIDED|95.0|1.66|11.03|||Regression, Logistic|||||11.03|1.66|0.003
91495156|NCT03129100|182862241|SUPERIORITY||Odds Ratio (OR)|4.42||||0.001|TWO_SIDED|95.0|1.77|11.02|||Regression, Logistic|||||11.02|1.77|0.001
91495157|NCT03129100|182862243|SUPERIORITY||Odds Ratio (OR)|4.51||||0.001|TWO_SIDED|95.0|1.78|11.41|||Regression, Logistic|||||11.41|1.78|0.001
91495158|NCT03129100|182862243|SUPERIORITY||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|1.88|11.31|||Regression, Logistic|||||11.31|1.88|<0.001
91495159|NCT03129100|182862244|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.11|12.69|||Regression, Logistic|||||12.69|2.11|<0.001
91495160|NCT03129100|182862244|SUPERIORITY||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|2.2|12.47|||Regression, Logistic|||||12.47|2.20|<0.001
91495161|NCT03129100|182862245|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|1.9|11.17|||Regression, Logistic|||||11.17|1.90|<0.001
91495162|NCT03129100|182862245|SUPERIORITY||Odds Ratio (OR)|3.55||||0.003|TWO_SIDED|95.0|1.56|8.09|||Regression, Logistic|||||8.09|1.56|0.003
91495163|NCT03129100|182862246|SUPERIORITY||Odds Ratio (OR)|4.92|||<|0.001|TWO_SIDED|95.0|2.07|11.72|||Regression, Logistic|||||11.72|2.07|<0.001
91733868|NCT01251757|183361646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.38|TWO_SIDED|95.0|-1.8|0.7||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.||0.7|-1.8|.38
91733869|NCT01251757|183361646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.019|TWO_SIDED|95.0|-2.7|-0.2||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||-0.2|-2.7|.019
91733870|NCT01251757|183361647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.59|TWO_SIDED|95.0|0.93|1.13||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.13|0.93|.59
91733871|NCT01251757|183361647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.058|TWO_SIDED|95.0|1.0|1.22||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.22|1.00|.058
91733872|NCT02284893|183361648|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1001||0.0008|||||||Mixed Models Analysis|||||||0.0008
91733873|NCT02284893|183361649|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.175||0.0034|||||||Regression, Logistic|the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.||||||0.0034
91733874|NCT02284893|183361650|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.2891||0.0001|||||||Mixed Models Analysis|||||||0.0001
91733875|NCT02284893|183361651|SUPERIORITY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|3.682||0.0001|||||||Mixed Models Analysis|||||||0.0001
91733876|NCT04992065|183361691|SUPERIORITY||Treatment difference|-31.95|||<|0.0001|TWO_SIDED|95.0|-43.02|-20.87|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-20.87|-43.02|<.0001
91733877|NCT04992065|183361691|SUPERIORITY||Treatment difference|-44.91|||<|0.0001|TWO_SIDED|95.0|-56.04|-33.79|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-33.79|-56.04|<.0001
91733878|NCT04992065|183361691|SUPERIORITY||Treatment difference|-61.83|||<|0.0001|TWO_SIDED|95.0|-72.94|-50.72|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-50.72|-72.94|<.0001
91733879|NCT04992065|183361691|SUPERIORITY||Treatment difference|33.32|||||TWO_SIDED|95.0|22.16|44.47||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||44.47|22.16|
91495164|NCT03129100|182862246|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.32|||Regression, Logistic|||||8.32|1.57|0.003
91733880|NCT04992065|183361691|SUPERIORITY||Treatment difference|20.35|||||TWO_SIDED|95.0|9.21|31.48||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||31.48|9.21|
91733881|NCT04992065|183361691|SUPERIORITY||Treatment difference|3.43|||||TWO_SIDED|95.0|-7.81|14.68||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||14.68|-7.81|
91733882|NCT00663260|183361717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1448||0.561|TWO_SIDED|95.0|-0.37|0.2||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.20|-0.37|0.561
91495165|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||Patient Global||-1.1|-3.1|<0.001
91495166|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.9|-1.0|||ANCOVA|||Patient Global||-1.0|-2.9|<0.001
91495167|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||ANCOVA|||Spinal Pain||-1.0|-3.1|<0.001
91495168|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||ANCOVA|||Spinal Pain||-0.8|-2.8|<0.001
91733883|NCT00663260|183361717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1457||0.435|TWO_SIDED|95.0|-0.4|0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.17|-0.40|0.435
91733884|NCT00663260|183361718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|8.142|||TWO_SIDED|95.0|-29.7|2.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||2.4|-29.7|
91733885|NCT00663260|183361718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|8.136|||TWO_SIDED|95.0|-25.0|7.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||7.0|-25.0|
91733886|NCT00663260|183361719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.4435|||TWO_SIDED|95.0|-2.68|-0.94||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-0.94|-2.68|
91733887|NCT00663260|183361719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.4395|||TWO_SIDED|95.0|-3.03|-1.29||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-1.29|-3.03|
91733888|NCT04562090|183361743|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.73|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-4.3|-3.16||Repeated Measures Analysis (RMA): CFB as response, treatment group (TG), visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.16|-4.30|<0.001
91733889|NCT04562090|183361746|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.62|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-3.25|-1.99||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.99|-3.25|<0.001
91733890|NCT04562090|183361746|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.47|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.93|-2.02||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-2.02|-2.93|<0.001
91733891|NCT04562090|183361746|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.96|-2.3||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.30|-3.96|<0.001
91733892|NCT04562090|183361746|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.39|-2.47||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.47|-3.39|<0.001
91733893|NCT04562090|183361746|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.47|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.37|-2.56||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-2.56|-4.37|<0.001
91733894|NCT04562090|183361746|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.59|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-4.06|-3.12||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.12|-4.06|<0.001
91733895|NCT04562090|183361747|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.66|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.88|-0.44||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.44|-0.88|<0.001
91733896|NCT04562090|183361747|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.81|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.97|-0.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.65|-0.97|<0.001
91495169|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|-2.39|-0.72|||ANCOVA|||BASFI||-0.72|-2.39|<0.001
91495170|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.409|<|0.001|TWO_SIDED|95.0|-2.2|-0.59|||ANCOVA|||BASFI||-0.59|-2.20|<0.001
91495171|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.448|<|0.001|TWO_SIDED|95.0|-3.05|-1.28|||ANCOVA|||Inflammation||-1.28|-3.05|<0.001
91495172|NCT03129100|182862247|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.433|<|0.001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||Inflammation||-0.95|-2.66|<0.001
91495173|NCT03129100|182862248|SUPERIORITY||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|2.13|13.35|||Regression, Logistic|||||13.35|2.13|<0.001
91495174|NCT03129100|182862248|SUPERIORITY||Odds Ratio (OR)|4.07||||0.001|TWO_SIDED|95.0|1.75|9.45|||Regression, Logistic|||||9.45|1.75|0.001
91495175|NCT03129100|182862249|SUPERIORITY||LS Mean Difference|-7.858|STANDARD_ERROR_OF_MEAN|1.9586|<|0.001|TWO_SIDED|95.0|-11.729|-3.987|||ANCOVA|||||-3.987|-11.729|<0.001
91495176|NCT03129100|182862249|SUPERIORITY||LS Mean Difference|-5.979|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.655|-2.304|||ANCOVA|||||-2.304|-9.655|0.002
91495177|NCT03129100|182862250|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.104||0.062|TWO_SIDED|95.0|-0.4|0.01|||ANCOVA|||||0.01|-0.40|0.062
91495178|NCT03129100|182862250|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.099||0.018|TWO_SIDED|95.0|-0.43|-0.04|||ANCOVA|||||-0.04|-0.43|0.018
91495179|NCT03129100|182862251|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.335||0.757|TWO_SIDED|95.0|-0.56|0.77|||ANCOVA|||||0.77|-0.56|0.757
91495180|NCT03129100|182862251|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.322||0.67|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|||||0.50|-0.77|0.670
91495181|NCT03129100|182862252|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.338||0.236|TWO_SIDED|95.0|-1.07|0.27|||ANCOVA|||||0.27|-1.07|0.236
91495182|NCT03129100|182862252|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.319||0.373|TWO_SIDED|95.0|-0.92|0.35|||ANCOVA|||||0.35|-0.92|0.373
91495183|NCT03129100|182862253|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.459||0.885|TWO_SIDED|95.0|-0.98|0.85|||ANCOVA|||||0.85|-0.98|0.885
91495184|NCT03129100|182862253|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.735|TWO_SIDED|95.0|-0.95|0.68|||ANCOVA|||||0.68|-0.95|0.735
91495185|NCT03129100|182862254|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.501||0.294|TWO_SIDED|95.0|-1.53|0.47|||ANCOVA|||||0.47|-1.53|0.294
91495186|NCT03129100|182862254|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.453||0.164|TWO_SIDED|95.0|-1.54|0.27|||ANCOVA|||||0.27|-1.54|0.164
91495187|NCT03129100|182862255|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.063|TWO_SIDED|95.0|-4.3|0.1|||ANCOVA|||||0.1|-4.3|0.063
91495188|NCT03129100|182862255|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.02||0.211|TWO_SIDED|95.0|-3.3|0.7|||ANCOVA|||||0.7|-3.3|0.211
91495189|NCT03129100|182862256|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.9||0.334|TWO_SIDED|95.0|-2.7|0.9|||ANCOVA|||||0.9|-2.7|0.334
91495190|NCT03129100|182862256|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.88||0.168|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|0.168
91495191|NCT03129100|182862258|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.1|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||||0.1|-1.5|0.100
91495192|NCT03129100|182862258|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.047|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||-0.0|-1.5|0.047
91495193|NCT03129100|182862259|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.479||0.068|TWO_SIDED|95.0|-1.83|0.06|||ANCOVA|||||0.06|-1.83|0.068
91495194|NCT03129100|182862259|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.465||0.307|TWO_SIDED|95.0|-1.4|0.44|||ANCOVA|||||0.44|-1.40|0.307
91495195|NCT03129100|182862260|SUPERIORITY||LS Mean Difference|2.6021|STANDARD_ERROR_OF_MEAN|1.4684||0.079|TWO_SIDED|95.0|-0.3011|5.5053|||ANCOVA|||||5.5053|-0.3011|0.079
91495196|NCT03129100|182862260|SUPERIORITY||LS Mean Difference|2.4096|STANDARD_ERROR_OF_MEAN|1.3978||0.087|TWO_SIDED|95.0|-0.3541|5.1734|||ANCOVA|||||5.1734|-0.3541|0.087
91495197|NCT03129100|182862261|SUPERIORITY||LS Mean Difference|0.837|STANDARD_ERROR_OF_MEAN|1.1752||0.477|TWO_SIDED|95.0|-1.4864|3.1605|||ANCOVA|||||3.1605|-1.4864|0.477
91495198|NCT03129100|182862261|SUPERIORITY||LS Mean Difference|2.3009|STANDARD_ERROR_OF_MEAN|1.1192||0.042|TWO_SIDED|95.0|0.088|4.5138|||ANCOVA|||||4.5138|0.0880|0.042
91495199|NCT03129100|182862262|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.058|TWO_SIDED|95.0|-2.02|0.04|||ANCOVA|||||0.04|-2.02|0.058
91495200|NCT03129100|182862262|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.497||0.147|TWO_SIDED|95.0|-1.71|0.26|||ANCOVA|||||0.26|-1.71|0.147
91495201|NCT03129100|182862263|SUPERIORITY||LS Mean Difference|0.0418|STANDARD_ERROR_OF_MEAN|0.0334||0.213|TWO_SIDED|95.0|-0.0329|0.1164|||ANCOVA|||||0.1164|-0.0329|0.213
91495202|NCT03129100|182862263|SUPERIORITY||LS Mean Difference|0.0388|STANDARD_ERROR_OF_MEAN|0.0319||0.225|TWO_SIDED|95.0|-0.0324|0.1101|||ANCOVA|||||0.1101|-0.0324|0.225
91495203|NCT03129100|182862264|SUPERIORITY||LS Mean Difference|-10.62|STANDARD_ERROR_OF_MEAN|4.383||0.017|TWO_SIDED|95.0|-19.28|-1.95|||ANCOVA|||Percentage of Activity Impairment||-1.95|-19.28|0.017
91495204|NCT03129100|182862264|SUPERIORITY||LS Mean Difference|-7.14|STANDARD_ERROR_OF_MEAN|4.199||0.091|TWO_SIDED|95.0|-15.44|1.16|||ANCOVA|||Percentage of Activity Impairment||1.16|-15.44|0.091
91495205|NCT03129100|182862265|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.66||0.531|TWO_SIDED|95.0|-1.7|0.9|||ANCOVA|||||0.9|-1.7|0.531
91495206|NCT03129100|182862265|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.743|TWO_SIDED|95.0|-1.4|1.0|||ANCOVA|||||1.0|-1.4|0.743
91495207|NCT03789474|182862268|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||.443
91495208|NCT03789474|182862269|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||.063
91495209|NCT03789474|182862270|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||||||.057
91495210|NCT03789474|182862271|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||.038
91495211|NCT03789474|182862272|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||.072
91495212|NCT03789474|182862273|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||.189
91495213|NCT03789474|182862274|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||.358
91495214|NCT03789474|182862275|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||.406
91495215|NCT03789474|182862276|SUPERIORITY|||||||0.256|||||||t-test, 2 sided|||||||.256
91529888|NCT04147260|182936097|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|90.0|-0.07|0.16|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.16|-0.07|
91529889|NCT04147260|182936097|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.055||0.572|TWO_SIDED|90.0|-0.14|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.14|0.572
91495216|NCT03789474|182862277|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
91495217|NCT03789474|182862278|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||||||.316
91495218|NCT03789474|182862279|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||.971
91495219|NCT03789474|182862280|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
91495220|NCT03789474|182862281|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||.009
91495221|NCT03789474|182862282|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||.704
91495222|NCT03789474|182862283|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
91495223|NCT03789474|182862284|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||.708
91495224|NCT03789474|182862285|SUPERIORITY|||||||0.711|||||||t-test, 2 sided|||||||.711
91495225|NCT03789474|182862286|SUPERIORITY|||||||0.956|||||||t-test, 2 sided|||||||.956
91495226|NCT03789474|182862287|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||.139
91529890|NCT04147260|182936097|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.075||0.315|TWO_SIDED|90.0|-0.07|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.07|0.315
91733897|NCT04562090|183361747|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.17|-0.58||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.58|-1.17|<0.001
91733898|NCT04562090|183361747|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.78||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.78|-1.10|<0.001
91733899|NCT04562090|183361747|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.71||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.71|-1.35|<0.001
91733900|NCT04562090|183361747|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.14|-0.81||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.81|-1.14|<0.001
91733901|NCT04562090|183361748|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.58|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.37|-0.58|<0.001
91733902|NCT04562090|183361748|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.53|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.38|-0.53|<0.001
91733903|NCT04562090|183361748|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.67|-0.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.39|-0.67|<0.001
91733904|NCT04562090|183361748|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.45|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.52|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.37|-0.52|<0.001
91733905|NCT04562090|183361748|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.38|-0.68|<0.001
91733906|NCT04562090|183361748|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.6|-0.45||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.45|-0.60|<0.001
91733907|NCT04562090|183361749|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-1.31|-0.9||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.90|-1.31|<0.001
91495227|NCT03789474|182862288|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||.035
91495228|NCT03789474|182862289|SUPERIORITY|||||||0.502|||||||t-test, 2 sided|||||||.502
91495229|NCT03789474|182862290|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
91495230|NCT03789474|182862291|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.380
91529891|NCT04147260|182936097|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.286|TWO_SIDED|90.0|-0.18|0.05||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.05|-0.18|0.286
91495231|NCT03789474|182862292|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||||||.914
91495232|NCT03789474|182862293|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|||||||.915
91495233|NCT03789474|182862294|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||.087
91495234|NCT03789474|182862295|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||.011
91495235|NCT03789474|182862296|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||.207
91733908|NCT04562090|183361749|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.25|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.96|-1.25|<0.001
91733909|NCT04562090|183361749|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.53|-0.99||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.99|-1.53|<0.001
91495236|NCT03789474|182862297|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
91495237|NCT03789474|182862298|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||||||.021
91529892|NCT04147260|182936097|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.077||0.057|TWO_SIDED|90.0|0.0|0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.31|0.00|0.057
91495238|NCT03789474|182862299|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91495239|NCT03789474|182862300|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
91495240|NCT03789474|182862301|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
91495241|NCT03789474|182862302|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
91495242|NCT03789474|182862303|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
91495243|NCT03789474|182862304|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
91495244|NCT03789474|182862305|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
91495245|NCT03789474|182862306|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.020
91495246|NCT03789474|182862307|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
91495247|NCT03789474|182862308|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
91495248|NCT03789474|182862309|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||.746
91495249|NCT03789474|182862310|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
91495250|NCT03789474|182862311|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
91495251|NCT03789474|182862312|SUPERIORITY|||||||0.043|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.043
91495252|NCT03789474|182862313|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.160
91733910|NCT04562090|183361749|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.34|-1.05||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-1.05|-1.34|<0.001
91733911|NCT04562090|183361749|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.54|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.96|-1.54|<0.001
91733912|NCT04562090|183361749|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.42|-1.12||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-1.12|-1.42|<0.001
91733913|NCT04562090|183361750|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-3.5|-2.43||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.43|-3.50|<0.001
91733914|NCT04562090|183361750|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-3.44|-2.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.65|-3.44|<0.001
91733915|NCT04562090|183361750|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.09|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-5.8|-4.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-4.39|-5.80|<0.001
91733916|NCT04562090|183361750|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-4.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-4.7|-3.9||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-3.90|-4.70|<0.001
91733917|NCT04562090|183361750|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-6.01|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-6.78|-5.24||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-5.24|-6.78|<0.001
91733918|NCT04562090|183361750|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.4|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-5.82|-4.98||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-4.98|-5.82|<0.001
91733919|NCT04562090|183361751|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.97|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.73|-1.21||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.21|-2.73|<0.001
91733920|NCT04562090|183361751|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.36|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.9|-1.81||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.81|-2.90|<0.001
91733921|NCT04562090|183361751|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-4.2|-2.2||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.20|-4.20|<0.001
91733922|NCT04562090|183361751|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-3.47|-2.37||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.37|-3.47|<0.001
91495253|NCT02010775|182862353|OTHER||Least Squares Mean (LS) Mean Difference|-3.88|||<|0.001|TWO_SIDED|95.0|-5.58|-2.19|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-2.19|-5.58|< 0.001
91495254|NCT02010775|182862353|OTHER||LS Mean Difference|-6.32|||<|0.001|TWO_SIDED|95.0|-8.02|-4.62|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-4.62|-8.02|<0.001
91495255|NCT02010775|182862353|OTHER||LS Mean Difference|-6.89|||<|0.001|TWO_SIDED|95.0|-8.56|-5.22|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-5.22|-8.56|<0.001
91495256|NCT02010775|182862353|OTHER||LS Mean Difference|-7.68|||<|0.001|TWO_SIDED|95.0|-9.35|-6.0|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-6.00|-9.35|<0.001
91733923|NCT00432965|183361753|SUPERIORITY||Odds Ratio (OR)|1.89||||0.007|TWO_SIDED|95.0|1.19|3.02|||Fisher Exact|||Time Frame: Days 0-114||3.02|1.19|0.007
91733924|NCT01903863|183361755|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91733925|NCT01903863|183361756|SUPERIORITY|||||||0.07||||||Intracranial hemorrhage|Fisher Exact|||||||0.07
91733926|NCT01903863|183361756|SUPERIORITY|||||||0.7||||||Surgical bleed|Fisher Exact|||||||0.7
91733927|NCT01903863|183361756|SUPERIORITY|||||||0.5||||||Gastrointestinal hemorrhage|Fisher Exact|||||||0.5
91733928|NCT01903863|183361757|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91733929|NCT01903863|183361758|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91495257|NCT02010775|182862354|OTHER||Percentage Difference|31.5||||0.008|TWO_SIDED|95.0|9.8|53.3|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using Cochran-Mantel-Haenszel (CMH) tests stratified by baseline MMPS.||||53.3|9.8|0.008
91529893|NCT04147260|182936098|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.02|0.49|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.49|-0.02|
91495258|NCT02010775|182862354|OTHER||Percentage Difference|48.2|||<|0.001|TWO_SIDED|95.0|28.6|67.8|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||67.8|28.6|< 0.001
91529894|NCT04147260|182936098|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|90.0|-0.2|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.20|
91529895|NCT04147260|182936098|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|90.0|-0.72|-0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.31|-0.72|<0.001
91529896|NCT04147260|182936098|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|90.0|0.24|0.8||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.80|0.24|<0.001
91529897|NCT04147260|182936098|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.01|TWO_SIDED|90.0|-0.62|-0.09||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.09|-0.62|0.010
91529898|NCT04147260|182936098|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.173||0.001|TWO_SIDED|90.0|0.24|0.93||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.93|0.24|0.001
91529899|NCT04147260|182936099|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.044|||TWO_SIDED|90.0|-0.05|0.1|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.10|-0.05|
91529900|NCT04147260|182936099|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.038||0.998|TWO_SIDED|90.0|-0.08|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.08|0.998
91529901|NCT04147260|182936099|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.618|TWO_SIDED|90.0|-0.08|0.13||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.13|-0.08|0.618
91495259|NCT02010775|182862354|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|< 0.001
91495260|NCT02010775|182862354|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|<0.001
91529902|NCT04147260|182936099|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|90.0|-0.1|0.23|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.23|-0.10|
91529903|NCT04147260|182936099|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.451|TWO_SIDED|90.0|-0.1|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.10|0.451
91529904|NCT04147260|182936099|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11||1|TWO_SIDED|90.0|-0.22|0.22||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.22|-0.22|1.000
91529905|NCT04147260|182936100|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|90.0|-0.15|0.36|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.36|-0.15|
91529906|NCT04147260|182936100|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.131||0.446|TWO_SIDED|90.0|-0.16|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.16|0.446
91702395|NCT00772005|183299678|SUPERIORITY_OR_OTHER|||||||0.2076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2076
91495261|NCT02984709|182862379|SUPERIORITY||Estimated Mean Difference|-0.17||||0.593|TWO_SIDED|95.0|-0.81|0.47||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.47|-0.81|0.593
91495262|NCT02984709|182862380|SUPERIORITY||Estimated Mean Difference|-1.137||||0.581|TWO_SIDED|95.0|-5.27|2.99||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||2.99|-5.27|0.581
91495263|NCT02984709|182862381|SUPERIORITY||Estimated Mean Difference|-0.587||||0.206|TWO_SIDED|95.0|-1.52|0.34||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.34|-1.52|0.206
91495264|NCT02984709|182862382|SUPERIORITY||Estimated Mean Difference|-2.494||||0.511|TWO_SIDED|95.0|-10.11|5.13||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Child-reported family conflict||5.13|-10.11|0.511
91495265|NCT02984709|182862382|SUPERIORITY||Estimated Mean Difference|-3.354||||0.19|TWO_SIDED|95.0|-8.44|1.73||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Parent-reported family conflict||1.73|-8.44|0.190
91733930|NCT01903863|183361759|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91733931|NCT01903863|183361760|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91495266|NCT02984709|182862383|SUPERIORITY||Estimated Mean Difference|0.396||||0.873|TWO_SIDED|95.0|-4.57|5.36||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||5.36|-4.57|0.873
91495267|NCT02984709|182862384|SUPERIORITY||Estimated Mean Difference|2.996||||0.603|TWO_SIDED|95.0|-8.57|14.56||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||14.56|-8.57|0.603
91733932|NCT01903863|183361761|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91733933|NCT01903863|183361762|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91733934|NCT03909971|183361790|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91733935|NCT05318287|183361849|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.083|TWO_SIDED||||||t-test, 2 sided|||||||.083
91733936|NCT05318287|183361850|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||t-test, 2 sided|||||||.010
91733937|NCT05318287|183361851|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.16|TWO_SIDED||||||t-test, 2 sided|||||||.160
91733938|NCT05318287|183361852|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.167|TWO_SIDED||||||t-test, 2 sided|||||||.167
91733939|NCT05318287|183361853|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.012|TWO_SIDED||||||t-test, 2 sided|||||||.012
91733940|NCT05318287|183361854|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.347|TWO_SIDED||||||t-test, 2 sided|||||||.347
91733941|NCT05318287|183361855|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.007|TWO_SIDED||||||t-test, 2 sided|||||||.007
91733942|NCT05318287|183361856|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
91733943|NCT05318287|183361857|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.403|TWO_SIDED||||||t-test, 2 sided|||||||.403
91733944|NCT05318287|183361858|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.194|TWO_SIDED||||||t-test, 2 sided|||||||.194
91733945|NCT03537508|183361905|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.86|||||TWO_SIDED|95.0|-4.38|8.64||||||Statistical analysis for Serogroup A||8.64|-4.38|
91733946|NCT03537508|183361905|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|8.75|||||TWO_SIDED|95.0|4.8|13.6||||||Statistical analysis for Serogroup C||13.60|4.80|
91733947|NCT03537508|183361905|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|4.09|||||TWO_SIDED|95.0|0.68|8.44||||||Statistical analysis for Serogroup Y||8.44|0.68|
91733948|NCT03537508|183361905|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.19|||||TWO_SIDED|95.0|-1.18|4.45||||||Statistical analysis for Serogroup W||4.45|-1.18|
91733949|NCT03537508|183361906|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|10.21|||||TWO_SIDED|95.0|4.98|15.59||||||Statistical analysis for Serogroup A||15.59|4.98|
91733950|NCT03537508|183361906|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|7.83|||||TWO_SIDED|95.0|5.31|10.96||||||Statistical analysis for Serogroup C||10.96|5.31|
91733951|NCT03537508|183361906|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|6.53|||||TWO_SIDED|95.0|4.01|9.62||||||Statistical analysis for Serogroup Y||9.62|4.01|
91733952|NCT03537508|183361906|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|5.72|||||TWO_SIDED|95.0|3.44|8.57||||||Statistical analysis for Serogroup W||8.57|3.44|
91733953|NCT00391716|183361934|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.|Mantel Haenszel|Extended Mantel-Haenszel Chi-square test for linear-by-linear association.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.04
91529907|NCT04147260|182936100|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.972|TWO_SIDED|90.0|-0.34|0.35||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.35|-0.34|0.972
91733954|NCT00391716|183361934|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED|||||linear dose effects for rates of abstinence were assessed using the extended Mantel-Haenszel chi-square test for linear association.|Mantel Haenszel|The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.02
91733955|NCT00391716|183361935|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
91733956|NCT00391716|183361936|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
91733957|NCT00391716|183361937|SUPERIORITY_OR_OTHER||||||<|0.003||||||Cumulative means over 12 weeks|ANOVA|||||||<0.003
91733958|NCT04632030|183361950|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Adjusted for age, education, and lifetime tobacco use|||3.6|.69|
91733959|NCT04632030|183361950|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|1.28|6.55|||||Adjusted for age, education, and lifetime tobacco use|||6.55|1.28|
91733960|NCT04632030|183361951|OTHER||Odds Ratio (OR)|2.88|||||TWO_SIDED|95.0|1.28|6.47|||||Adjusted for age, education, and lifetime tobacco use|||6.47|1.28|
91495268|NCT01362205|182862421|OTHER|||||||0.2454|||||||Wilcoxon (Mann-Whitney)|||||||0.2454
91495269|NCT02854631|182862445|SUPERIORITY|||||||1|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||1.00
91495270|NCT02854631|182862446|SUPERIORITY|||||||0.061|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.061
91495271|NCT02854631|182862447|SUPERIORITY|||||||0.06|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.060
91733961|NCT04632030|183361951|OTHER||Odds Ratio (OR)|2.87|||||TWO_SIDED|95.0|1.26|6.5|||||Adjusted for age, education, and lifetime tobacco use|||6.50|1.26|
91733962|NCT04632030|183361952|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.59|3.86|||||Adjusted for age, education, and lifetime tobacco use|||3.86|.59|
91733963|NCT04632030|183361952|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.73|4.67|||||Adjusted for age, education, and lifetime tobacco use|||4.67|.73|
91733964|NCT04632030|183361953|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.53|2.99|||||Adjusted for age, education, and lifetime tobacco use|||2.99|.53|
91733965|NCT04632030|183361953|OTHER||Odds Ratio (OR)|2.19|||||TWO_SIDED|95.0|0.94|5.13|||||Adjusted for age, education, and lifetime tobacco use|||5.13|.94|
91733966|NCT00964678|183361954|SUPERIORITY|||||||0.028|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
91733967|NCT00964678|183361955|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
91733968|NCT00964678|183361956|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||>0.05
91733969|NCT00964678|183361957|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0|||||ANOVA|||||||>0.05
91733970|NCT01323192|183361972|SUPERIORITY_OR_OTHER||Difference in least square means|-4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.7|-2.4|||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||-2.4|-6.7|<0.0001
91733971|NCT01323192|183361973|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0002
91733972|NCT01323192|183361974|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91733973|NCT01323192|183361975|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91733974|NCT01323192|183361976|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0003|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0003
91733975|NCT01323192|183361977|SUPERIORITY_OR_OTHER|||||||0.4041|||||||ANCOVA|||||||0.4041
91733976|NCT01168596|183361983|SUPERIORITY_OR_OTHER||Slope|1.3|STANDARD_ERROR_OF_MEAN|5.26||0.81|TWO_SIDED|95.0|-9.13|11.73|||Regression, Linear|||||11.73|-9.13|0.81
91733977|NCT01168596|183361984|SUPERIORITY_OR_OTHER||Slope|4.38|STANDARD_ERROR_OF_MEAN|3.6||0.23|TWO_SIDED|95.0|-2.75|11.51|||Regression, Linear|||||11.51|-2.75|0.23
91733978|NCT01168596|183361985|SUPERIORITY_OR_OTHER||Slope|1.61|STANDARD_ERROR_OF_MEAN|5.03||0.75|TWO_SIDED|95.0|-8.37|11.59|||Regression, Linear|||||11.59|-8.37|0.75
91733979|NCT01168596|183361986|SUPERIORITY_OR_OTHER||Slope|1.88|STANDARD_ERROR_OF_MEAN|3.06||0.54|TWO_SIDED|95.0|-4.18|7.94|||Regression, Linear|||||7.94|-4.18|0.54
91733980|NCT01168596|183361987|SUPERIORITY_OR_OTHER||Slope|-5.17|STANDARD_ERROR_OF_MEAN|6.36||0.42|TWO_SIDED|95.0|-17.76|7.43|||Regression, Linear|||||7.43|-17.76|0.42
91733981|NCT01168596|183361988|SUPERIORITY_OR_OTHER||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.47||0.44|TWO_SIDED|95.0|-0.56|1.29|||Regression, Linear|||||1.29|-0.56|0.44
91733982|NCT01168596|183361989|SUPERIORITY_OR_OTHER||Slope|2.27|STANDARD_ERROR_OF_MEAN|10.02||0.82|TWO_SIDED|95.0|-17.59|22.13|||Regression, Linear|||||22.13|-17.59|0.82
91733983|NCT01168596|183361990|SUPERIORITY_OR_OTHER||Slope|-4.73|STANDARD_ERROR_OF_MEAN|7.36||0.52|TWO_SIDED|95.0|-19.31|9.85|||Regression, Linear|||||9.85|-19.31|0.52
91733984|NCT01168596|183361991|SUPERIORITY_OR_OTHER||Slope|0.11|STANDARD_ERROR_OF_MEAN|1.14||0.93|TWO_SIDED|95.0|-2.15|2.36|||Regression, Linear|||||2.36|-2.15|0.93
91733985|NCT01168596|183361992|SUPERIORITY_OR_OTHER||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.47||0.82|TWO_SIDED|95.0|-1.05|0.83|||Regression, Linear|||||0.83|-1.05|0.82
91733986|NCT01168596|183361993|SUPERIORITY_OR_OTHER||Slope|-4.53|STANDARD_ERROR_OF_MEAN|7.68||0.56|TWO_SIDED|95.0|-19.74|10.69|||Regression, Linear|||||10.69|-19.74|0.56
91733987|NCT01168596|183361994|SUPERIORITY_OR_OTHER||Slope|-2.21|STANDARD_ERROR_OF_MEAN|2.93||0.45|TWO_SIDED|95.0|-8.02|3.59|||Regression, Linear|||||3.59|-8.02|0.45
91733988|NCT01168596|183361995|SUPERIORITY_OR_OTHER||Slope|2.76|STANDARD_ERROR_OF_MEAN|4.94||0.58|TWO_SIDED|95.0|-7.02|12.55|||Regression, Linear|||||12.55|-7.02|0.58
91733989|NCT01168596|183361996|SUPERIORITY_OR_OTHER||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.54||0.95|TWO_SIDED|95.0|-1.04|1.11|||Regression, Linear|||||1.11|-1.04|0.95
91733990|NCT01168596|183361997|SUPERIORITY_OR_OTHER||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.54||0.48|TWO_SIDED|95.0|-1.45|0.69|||Regression, Linear|||||0.69|-1.45|0.48
91733991|NCT01168596|183361998|SUPERIORITY_OR_OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.84|TWO_SIDED|95.0|-0.71|0.58|||Regression, Linear|||||0.58|-0.71|0.84
91733992|NCT01168596|183361999|SUPERIORITY_OR_OTHER||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.44|TWO_SIDED|95.0|-0.77|1.76|||Regression, Linear|||||1.76|-0.77|0.44
91733993|NCT01168596|183362000|SUPERIORITY_OR_OTHER||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.88||0.71|TWO_SIDED|95.0|-2.06|1.41|||Regression, Linear|||||1.41|-2.06|0.71
91733994|NCT01168596|183362001|SUPERIORITY_OR_OTHER||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.64||0.31|TWO_SIDED|95.0|-0.62|1.9|||Regression, Linear|||||1.90|-0.62|0.31
91733995|NCT01168596|183362002|SUPERIORITY_OR_OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.82||0.94|TWO_SIDED|95.0|-1.68|1.56|||Regression, Linear|||||1.56|-1.68|0.94
91733996|NCT01276704|183362003|SUPERIORITY|||||||0.72||||||a priori threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||83% power to detect an absolute 2.5% reduction in Ki-67 for the treatment group compared with no reduction in the control group.||||0.72
91733997|NCT01276704|183362004|SUPERIORITY|||||||0.018||||||No adjustment for multiple comparisons. Standard threshold of P\<0.05|Wilcoxon (Mann-Whitney)|||||||0.018
91733998|NCT01276704|183362005|SUPERIORITY|||||||0.036||||||No adjustment for multiple comparisons. Standard threshold of P \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.036
91495272|NCT02854631|182862448|SUPERIORITY|||||||0.22||||||P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|Fisher Exact|||||||0.22
91733999|NCT00710593|183362007|SUPERIORITY_OR_OTHER||% of participants who were responders|97.5||||0.1613|TWO_SIDED|95.0|86.8|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|86.8|0.1613
91734000|NCT00710593|183362008|SUPERIORITY_OR_OTHER||% of participants who were responders|96.8||||0.0534|TWO_SIDED|95.0|89.0|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|89.0|0.0534
91734001|NCT00710593|183362009|SUPERIORITY_OR_OTHER||% of participants who were responders|96.1||||0.0427|TWO_SIDED|95.0|86.5|99.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.5|86.5|0.0427
91734002|NCT00710593|183362010|SUPERIORITY_OR_OTHER||% of participants who were responders|92.5||||0.0006|TWO_SIDED|95.0|83.4|97.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||97.5|83.4|0.0006
91734003|NCT00710593|183362011|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|49.3||||0.8305|TWO_SIDED|95.0||||The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
91734004|NCT00710593|183362011|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|46.7||||0.8305|TWO_SIDED|||||The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
91734005|NCT00710593|183362019|SUPERIORITY_OR_OTHER||Overall aquisition rate|7.9||||1||95.0|||||Fisher Exact|P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.||||||1.000
91734006|NCT00710593|183362020|SUPERIORITY_OR_OTHER||Overall aquisition rate|1.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91734007|NCT00710593|183362021|SUPERIORITY_OR_OTHER||Overall aquisition rate|2.0||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91734008|NCT00710593|183362022|SUPERIORITY_OR_OTHER||Overall aquisition rate|4.5||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91734009|NCT00710593|183362023|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91734010|NCT00710593|183362024|SUPERIORITY_OR_OTHER||Overall aquistion rate|3.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91734011|NCT00710593|183362025|SUPERIORITY_OR_OTHER||Overall aquisition rate|6.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91495273|NCT02854631|182862464|SUPERIORITY|||||||0.3|||||||Fisher Exact|Fisher's exact test (2-sided) was used to explore differences between groups in the percentage of participants with response/non-response.||||||0.30
91513308|NCT01975389|182898151|SUPERIORITY||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.81|0.83|||MMRM|||Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.83|0.81|<0.001
91513309|NCT01975389|182898151|SUPERIORITY||LS mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.67|0.69|||MMRM|||Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.69|0.67|<0.001
91513310|NCT01975389|182898152|SUPERIORITY||LS mean difference|1.06||||0.002|TWO_SIDED|95.0|1.02|1.09|||MMRM|||LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance.||1.09|1.02|0.002
91513311|NCT01312961|182898153|SUPERIORITY||Odds Ratio (OR)|0.077|||<|0.0001|TWO_SIDED|95.0|0.021|0.28||Threshold for significance at 0.05 level.|Regression, Logistic||Dupilumab 300 mg vs. Placebo|Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.||0.280|0.021|<0.0001
91513312|NCT03735862|182898171|OTHER|Paired t-Test|||||<|0.001|||||||t-test, 1 sided|||Difference between baseline and follow-up||||<0.001
91513313|NCT03735862|182898172|SUPERIORITY||||||<|0.0001|||||||McNemar|||Difference between baseline and follow-up||||<0.0001
91513314|NCT01720069|182898198|SUPERIORITY|||||||0.772|||||||ANCOVA|||||||0.772
91513315|NCT01720069|182898199|SUPERIORITY|||||||0.891|||||||ANCOVA|||||||0.891
91513316|NCT01720069|182898200|SUPERIORITY|||||||0.066|||||||ANCOVA|||||||0.066
91513317|NCT01720069|182898201|SUPERIORITY|||||||0.063|||||||ANCOVA|||||||0.063
91513318|NCT01720069|182898202|SUPERIORITY|||||||0.054|||||||ANCOVA|||||||0.054
91513319|NCT01720069|182898203|SUPERIORITY|||||||0.168|||||||Fisher Exact|||||||0.168
91513320|NCT01720069|182898203|SUPERIORITY|||||||0.363|||||||Fisher Exact|||||||0.363
91513321|NCT01720069|182898203|SUPERIORITY|||||||0.805|||||||Fisher Exact|||||||0.805
91513322|NCT00360334|182898205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.71|||<|0.001||95.0|2.62|8.46|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome||8.46|2.62|<0.001
91734012|NCT00710593|183362026|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.1||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
91734013|NCT00710593|183362027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.0004|TWO_SIDED|95.0|1.02|1.1|||Regression, Logistic|||||1.1|1.02|0.0004
91734014|NCT00710593|183362028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0012|TWO_SIDED|95.0|1.0|1.1|||Regression, Logistic|||||1.1|1.0|0.0012
91734015|NCT00710593|183362029|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91734016|NCT03801525|183362074|SUPERIORITY||Hazard Ratio (HR)|0.778||||0.696|TWO_SIDED|95.0|0.219|2.755|||Log Rank|||||2.755|0.219|0.6960
91734017|NCT03801525|183362081|SUPERIORITY||Hazard Ratio (HR)|0.201||||0.1038|TWO_SIDED|95.0|0.023|1.721|||Log Rank|||||1.721|0.023|0.1038
91734018|NCT03309202|183362082|OTHER||Mean Difference (Final Values)|130.47|||||TWO_SIDED|90.0|101.57|167.6|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.60|101.57|
91734019|NCT03309202|183362082|OTHER||Mean Difference (Final Values)|117.49|||||TWO_SIDED|90.0|91.46|150.93|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||150.93|91.46|
91734020|NCT03309202|183362082|OTHER||Mean Difference (Final Values)|130.55|||||TWO_SIDED|90.0|101.63|167.7|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.70|101.63|
91734021|NCT03309202|183362083|OTHER||Mean Difference (Final Values)|136.37|||||TWO_SIDED|90.0|94.63|196.53|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||196.53|94.63|
91734022|NCT03309202|183362083|OTHER||Mean Difference (Final Values)|124.23|||||TWO_SIDED|90.0|86.2|179.03|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||179.03|86.20|
91734023|NCT03309202|183362083|OTHER||Mean Difference (Final Values)|118.65|||||TWO_SIDED|90.0|82.33|170.99|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||170.99|82.33|
91734024|NCT03309202|183362084|OTHER||Mean Difference (Final Values)|124.7309|||||TWO_SIDED|90.0|82.5275|188.5165|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||188.5165|82.5275|
91734025|NCT03309202|183362084|OTHER||Mean Difference (Final Values)|147.0778|||||TWO_SIDED|90.0|97.3132|222.2911|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||222.2911|97.3132|
91734026|NCT03309202|183362084|OTHER||Mean Difference (Final Values)|224.7373|||||TWO_SIDED|90.0|148.6962|339.6647|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||339.6647|148.6962|
91734027|NCT03309202|183362085|OTHER||Mean Difference (Final Values)|162.58|||||TWO_SIDED|90.0|103.12|256.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||256.32|103.12|
91734028|NCT03309202|183362085|OTHER||Mean Difference (Final Values)|172.74|||||TWO_SIDED|90.0|109.56|272.35|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||272.35|109.56|
91734029|NCT03309202|183362085|OTHER||Mean Difference (Final Values)|293.31|||||TWO_SIDED|90.0|186.04|462.44|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||462.44|186.04|
91734030|NCT03309202|183362086|OTHER||Mean Difference (Final Values)|169.84|||||TWO_SIDED|90.0|104.02|277.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||277.32|104.02|
91734031|NCT03309202|183362086|OTHER||Mean Difference (Final Values)|182.51|||||TWO_SIDED|90.0|111.78|298.02|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||298.02|111.78|
91734032|NCT03309202|183362086|OTHER||Mean Difference (Final Values)|266.29|||||TWO_SIDED|90.0|163.08|434.8|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||434.80|163.08|
91734033|NCT03243084|183362103|SUPERIORITY|||||||0.319||||||Threshold for significance is \<.05.|ANOVA|||A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables||||.319
91734034|NCT03243084|183362105|SUPERIORITY|||||||0.0488||||||Threshold for significance is \<.05.|Wilcoxon (Mann-Whitney)|||Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index \[(Pre-Post)/(Pre+Post)\]||||.0488
91734035|NCT05870345|183362113|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
91734036|NCT05870345|183362114|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
91734037|NCT04562116|183362132|OTHER||Ratio|94.59||||0.5789|TWO_SIDED|90.0|79.57|112.45||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||112.45|79.57|0.5789
91734038|NCT04562116|183362132|OTHER||Ratio|99.34||||0.9468|TWO_SIDED|90.0|83.66|117.96||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.96|83.66|0.9468
91734039|NCT04562116|183362132|OTHER||Ratio|107.81||||0.1364|TWO_SIDED|90.0|99.14|117.24||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.24|99.14|0.1364
91734040|NCT04562116|183362132|OTHER||Ratio|92.13||||0.1915|TWO_SIDED|90.0|82.85|102.44||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||102.44|82.85|0.1915
91734041|NCT04562116|183362132|OTHER||Ratio|101.67||||0.5059|TWO_SIDED|90.0|97.41|106.12||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||106.12|97.41|0.5059
91734042|NCT04562116|183362133|OTHER||Ratio|95.82||||0.6665|TWO_SIDED|90.0|80.72|113.75||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||113.75|80.72|0.6665
91734043|NCT04562116|183362133|OTHER||Ratio|99.15||||0.9316|TWO_SIDED|90.0|83.43|117.83||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.83|83.43|0.9316
91529908|NCT04147260|182936100|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.02|0.6|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.60|-0.02|
91734044|NCT04562116|183362133|OTHER||Ratio|107.75||||0.1371|TWO_SIDED|90.0|99.12|117.13||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.13|99.12|0.1371
91734045|NCT04562116|183362133|OTHER||Ratio|88.66||||0.0962|TWO_SIDED|90.0|78.72|99.85||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||99.85|78.72|0.0962
91734046|NCT04562116|183362133|OTHER||Ratio|100.81||||0.6807|TWO_SIDED|90.0|97.45|104.29||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.29|97.45|0.6807
91734047|NCT04562116|183362134|OTHER||Ratio|91.22||||0.3431|TWO_SIDED|90.0|77.3|107.63||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||107.63|77.30|0.3431
91734048|NCT04562116|183362134|OTHER||Ratio|91.05||||0.4277|TWO_SIDED|90.0|74.33|111.53||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||111.53|74.33|0.4277
91734049|NCT04562116|183362134|OTHER||Ratio|94.79||||0.4963|TWO_SIDED|90.0|82.8|108.52||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||108.52|82.80|0.4963
91734050|NCT04562116|183362134|OTHER||Ratio|88.24||||0.1931|TWO_SIDED|90.0|75.08|103.7||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||103.70|75.08|0.1931
91734051|NCT04562116|183362134|OTHER||Ratio|92.94||||0.296|TWO_SIDED|90.0|82.51|104.69||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.69|82.51|0.2960
91513323|NCT00360334|182898206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.001||95.0|3.11|10.64|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||10.64|3.11|<0.001
91734052|NCT02908178|183362157|OTHER||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|99.0|1.18|1.63||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.||1.63|1.18|<.001
91734053|NCT02908178|183362157|OTHER||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|99.0|2.27|8.75||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.||8.75|2.27|<.001
91734054|NCT02908178|183362157|OTHER||Odds Ratio (OR)|1.24|||<|0.001|TWO_SIDED|99.0|1.0|1.54||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.||1.54|1.00|<.001
91734055|NCT02908178|183362157|OTHER||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|99.0|1.03|1.91||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.||1.91|1.03|<.001
91734056|NCT02908178|183362157|OTHER||Odds Ratio (OR)|1.31||||0.003|TWO_SIDED|99.0|1.04|1.65||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.||1.65|1.04|.003
91734057|NCT02908178|183362158|OTHER||||||<|0.001||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.||||<.001
91734058|NCT02908178|183362159|OTHER|||||||0.48||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.||||.48
91734059|NCT02908178|183362160|OTHER||Hazard Ratio (HR)|0.88|||<|0.001|TWO_SIDED|99.0|0.73|1.05||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.||1.05|0.73|<.001
91734060|NCT02908178|183362161|OTHER||Hazard Ratio (HR)|1.09||||0.207|TWO_SIDED|99.0|1.0|1.2||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.||1.20|1.00|0.207
91734061|NCT02908178|183362161|OTHER||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|99.0|1.12|2.11||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.||2.11|1.12|<.001
91734062|NCT02908178|183362161|OTHER||Hazard Ratio (HR)|0.98||||0.113|TWO_SIDED|99.0|0.87|1.1||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.||1.10|0.87|0.113
91734063|NCT02908178|183362161|OTHER||Hazard Ratio (HR)|1.21||||0.01|TWO_SIDED|99.0|0.93|1.58||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.||1.58|0.93|0.010
91734064|NCT02908178|183362161|OTHER||Hazard Ratio (HR)|1.1||||0.029|TWO_SIDED|99.0|0.98|1.25||P-value is unadjusted. Threshold for statistical significance is 0.01|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.||1.25|0.98|0.029
91513324|NCT00360334|182898207|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91734065|NCT02908178|183362162|OTHER||Hazard Ratio (HR)|1.13||||0.861|TWO_SIDED|99.0|0.54|2.35||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.||2.35|0.54|0.861
91734066|NCT02908178|183362163|OTHER||Hazard Ratio (HR)|1.03||||0.603|TWO_SIDED|99.0|0.71|1.51||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.||1.51|0.71|0.603
91734067|NCT02908178|183362164|OTHER||Hazard Ratio (HR)|1.17||||0.62|TWO_SIDED|99.0|0.81|1.69||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.||1.69|0.81|0.620
91734068|NCT01506726|183362165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.23|TWO_SIDED|95.0|-2.08|0.2|||Wilcoxon (Mann-Whitney)|Wilcoxon two sample test||||0.20|-2.08|0.230
91734069|NCT01506726|183362166|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||t-test, 2 sided|||||||0.347
91734070|NCT01506726|183362167|SUPERIORITY_OR_OTHER|||||||0.857|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.857
91734071|NCT01506726|183362167|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.706
91734072|NCT01506726|183362167|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.014
91734073|NCT01506726|183362167|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.136
91529909|NCT04147260|182936100|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.15||0.091|TWO_SIDED|90.0|-0.04|0.56||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.56|-0.04|0.091
91734074|NCT01506726|183362167|SUPERIORITY_OR_OTHER|||||||0.803|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.803
91734075|NCT01506726|183362167|SUPERIORITY_OR_OTHER|||||||0.894|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.894
91734076|NCT01506726|183362168|SUPERIORITY_OR_OTHER|||||||0.143|TWO_SIDED|||||P value comparing change in IL6 between treatment groups.|t-test, 2 sided|||||||0.143
91734077|NCT01506726|183362168|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED|||||P value comparing the change in TNF between treatment groups.|t-test, 2 sided|||||||0.257
91734078|NCT01506726|183362169|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED|||||P-value comparing the change in EPO between treatment groups.|t-test, 2 sided|||||||0.535
91529910|NCT04147260|182936100|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.203||0.88|TWO_SIDED|90.0|-0.38|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.38|0.880
91734079|NCT01506726|183362170|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED||||||t-test, 2 sided|||||||0.232
91734080|NCT01506726|183362171|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED||||||t-test, 2 sided|||||||0.076
91734081|NCT01506726|183362172|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
91734082|NCT01506726|183362173|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||t-test, 2 sided|||||||0.187
91734083|NCT01506726|183362174|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
91734084|NCT01506726|183362175|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||t-test, 2 sided|||||||0.619
91734085|NCT01506726|183362176|SUPERIORITY_OR_OTHER|||||||0.642|TWO_SIDED||||||t-test, 2 sided|||||||0.642
91734086|NCT01506726|183362177|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||||||0.42
91734087|NCT01506726|183362178|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
91734088|NCT01506726|183362179|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Chi-squared|||||||0.375
91734089|NCT01506726|183362181|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
91734090|NCT01506726|183362182|SUPERIORITY_OR_OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
91734091|NCT02231580|183362188|SUPERIORITY_OR_OTHER||GLS mean ratio|1.104|||=|0.5743|TWO_SIDED|90.0|0.823|1.482|||MMRM|||Left hand position-index statistical analysis is presented (BN82451B versus Placebo). The Mixed Effect Model Repeat Measurement (MMRM) analysis was performed on log-transformed data using the restricted maximum likelihood (REML) model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.482|0.823|=0.5743
91495274|NCT01179568|182862499|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|0.82|1.81|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)||1.81|0.82|<0.05
91734092|NCT02231580|183362188|SUPERIORITY_OR_OTHER||GLS mean ratio|1.141|||=|0.4349|TWO_SIDED|90.0|0.862|1.51|||MMRM|||Right hand position-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.510|0.862|=0.4349
91734093|NCT02231580|183362189|SUPERIORITY_OR_OTHER||GLS mean ratio|1.035|||=|0.8937|TWO_SIDED|90.0|0.675|1.587|||MMRM|||Left hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.587|0.675|=0.8937
91734094|NCT02231580|183362189|SUPERIORITY_OR_OTHER||GLS mean ratio|1.093|||=|0.636|TWO_SIDED|90.0|0.8|1.493|||MMRM|||Right hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.493|0.800|=0.6360
91734095|NCT02231580|183362190|SUPERIORITY_OR_OTHER||GLS mean ratio|1.247|||=|0.2865|TWO_SIDED|90.0|0.886|1.756|||MMRM|||Left hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.756|0.886|=0.2865
91734096|NCT02231580|183362190|SUPERIORITY_OR_OTHER||GLS mean ratio|1.16|||=|0.5338|TWO_SIDED|90.0|0.781|1.724|||MMRM|||Right hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.724|0.781|=0.5338
91734097|NCT02231580|183362191|SUPERIORITY_OR_OTHER||GLS mean ratio|0.693|||=|0.0864|TWO_SIDED|90.0|0.487|0.985|||MMRM|||Left hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.985|0.487|=0.0864
91734098|NCT02231580|183362191|SUPERIORITY_OR_OTHER||GLS mean ratio|0.686|||=|0.0399|TWO_SIDED|90.0|0.508|0.925|||MMRM|||Right hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.925|0.508|=0.0399
91734099|NCT02231580|183362192|SUPERIORITY_OR_OTHER||GLS mean ratio|1.509|||=|0.0574|TWO_SIDED|90.0|1.06|2.15|||MMRM|||Left finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.150|1.060|=0.0574
91495275|NCT01179568|182862499|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.88|1.17|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.||1.17|0.88|<0.05
91734100|NCT02231580|183362192|SUPERIORITY_OR_OTHER||GLS mean ratio|0.953|||=|0.8277|TWO_SIDED|90.0|0.662|1.372|||MMRM|||Right finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.372|0.662|=0.8277
91513325|NCT00360334|182898208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.28||95.0|0.44|1.26|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.26|0.44|0.280
91734101|NCT02231580|183362192|SUPERIORITY_OR_OTHER||GLS mean ratio|1.238|||=|0.0162|TWO_SIDED|90.0|1.074|1.426|||MMRM|||Left finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.426|1.074|=0.0162
91734102|NCT02231580|183362192|SUPERIORITY_OR_OTHER||GLS mean ratio|1.038|||=|0.632|TWO_SIDED|90.0|0.912|1.182|||MMRM|||Right finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.182|0.912|=0.6320
91760029|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.59|-0.14||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.14|-0.59|
91495276|NCT01179568|182862499|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|1.0|1.46|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.||1.46|1|<0.05
91734103|NCT02231580|183362193|SUPERIORITY_OR_OTHER||GLS mean ratio|1.308|||=|0.3005|TWO_SIDED|90.0|0.85|2.014|||MMRM|||Left finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.014|0.85|=0.3005
91734104|NCT02231580|183362193|SUPERIORITY_OR_OTHER||GLS mean ratio|1.177|||=|0.4793|TWO_SIDED|90.0|0.804|1.722|||MMRM|||Right finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.722|0.804|=0.4793
91734105|NCT02231580|183362193|SUPERIORITY_OR_OTHER||GLS mean ratio|1.15|||=|0.2653|TWO_SIDED|90.0|0.934|1.416|||MMRM|||Left finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.416|0.934|=0.2653
91734106|NCT02231580|183362193|SUPERIORITY_OR_OTHER||GLS mean ratio|1.045|||=|0.6777|TWO_SIDED|90.0|0.875|1.248|||MMRM|||Right finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.248|0.875|=0.6777
91734107|NCT02231580|183362194|SUPERIORITY_OR_OTHER||GLS mean ratio|1.618|||=|0.0326|TWO_SIDED|90.0|1.124|2.331|||MMRM|||Left finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.331|1.124|=0.0326
91734108|NCT02231580|183362194|SUPERIORITY_OR_OTHER||GLS mean ratio|0.886|||=|0.6016|TWO_SIDED|90.0|0.605|1.299|||MMRM|||Right finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.299|0.605|=0.6016
91495277|NCT01179568|182862500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.04||0.74|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||0.74
91495278|NCT01179568|182862501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|1.98||0.53|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.53
91495279|NCT01179568|182862501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.37|STANDARD_ERROR_OF_MEAN|2.08|<|0.001|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||<.001
91495280|NCT01179568|182862502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.57||0.59|TWO_SIDED|||||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.59
91495281|NCT01179568|182862503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.44||0.4|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.40
91734109|NCT02231580|183362194|SUPERIORITY_OR_OTHER||GLS mean ratio|1.242|||=|0.0152|TWO_SIDED|90.0|1.077|1.433|||MMRM|||Left finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.433|1.077|=0.0152
91734110|NCT02231580|183362194|SUPERIORITY_OR_OTHER||GLS mean ratio|1.042|||=|0.6033|TWO_SIDED|90.0|0.915|1.186|||MMRM|||Right finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.186|0.915|=0.6033
91734111|NCT02231580|183362195|SUPERIORITY_OR_OTHER||GLS mean ratio|1.657|||=|0.052|TWO_SIDED|90.0|1.086|2.529|||MMRM|||Left finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.529|1.086|=0.0520
91495282|NCT01179568|182862503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|1.46||0.005|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.005
91495283|NCT03727347|182862504|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the improvement (decrease) in rTNSS mean score, from baseline to 12 weeks, would exceed 1 point||||||<0.0001
91529911|NCT04147260|182936101|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.043|||TWO_SIDED|90.0|-0.15|-0.01|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||-0.01|-0.15|
91734112|NCT02231580|183362195|SUPERIORITY_OR_OTHER||GLS mean ratio|0.916|||=|0.6978|TWO_SIDED|90.0|0.63|1.333|||MMRM|||Right finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.333|0.630|=0.6978
91734113|NCT02231580|183362195|SUPERIORITY_OR_OTHER||GLS mean ratio|1.298|||=|0.0522|TWO_SIDED|90.0|1.043|1.614|||MMRM|||Left finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.614|1.043|=0.0522
91734114|NCT02231580|183362195|SUPERIORITY_OR_OTHER||GLS mean ratio|1.014|||=|0.9012|TWO_SIDED|90.0|0.837|1.229|||MMRM|||Right finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.837|=0.9012
91734115|NCT02231580|183362196|SUPERIORITY_OR_OTHER||GLS mean ratio|1.198|||=|0.1779|TWO_SIDED|90.0|0.96|1.494|||MMRM|||Left finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.494|0.96|=0.1779
91495284|NCT02881554|182862517|OTHER|Non-parametric|Median Difference (Final Values)|0.12|||<|0.05|TWO_SIDED|||||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in TLF between mid-treatment and baseline. Wilcoxon (Mann-Whitney) tests were performed assessing the longitudinal difference between mid-treatment TLF from baseline TLF.||||<0.05
91495285|NCT02881554|182862517|OTHER|Non-parametric|Median Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|||||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in TLF between mid-treatment and baseline. Wilcoxon (Mann-Whitney) tests were performed assessing the longitudinal difference between post-treatment TLF from baseline TLF.||||<0.001
91495286|NCT02881554|182862517|OTHER|Non-parametric|Median Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|||||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in TLF between mid-treatment and baseline. Wilcoxon (Mann-Whitney) tests were performed assessing the longitudinal difference between mid-treatment TLF from baseline TLF.||||<0.05
91495287|NCT02881554|182862517|OTHER|Non-parametric|Median Difference (Final Values)|0.15|||<|0.01|TWO_SIDED|||||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in TLF between mid-treatment and baseline. Wilcoxon (Mann-Whitney) tests were performed assessing the longitudinal difference between post-treatment TLF from baseline TLF.||||<0.01
91495288|NCT02881554|182862517|OTHER|Non-parametric|Median Difference (Final Values)|0.03||||0.13|TWO_SIDED|||||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in TLF between mid-treatment and baseline. Wilcoxon (Mann-Whitney) tests were performed assessing the longitudinal difference between mid-treatment TLF from baseline TLF.||||0.13
91495289|NCT02881554|182862517|OTHER|Non-parametric|Median Difference (Final Values)|0.09|||<|0.05|TWO_SIDED|||||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in TLF between mid-treatment and baseline. Wilcoxon (Mann-Whitney) tests were performed assessing the longitudinal difference between post-treatment TLF from baseline TLF.||||<0.05
91495290|NCT02881554|182862517|OTHER|Non-parametric|Spearman's correlation coefficient|-0.61||||0.002|TWO_SIDED|||||Statistically significant p-value is \<0.05|Spearman rank correlation|||Null hypothesis = no monotonic association between the baseline TLF and Child-Pugh scores. Spearman rank correlation was performed to assess association between baseline TLF and Child-Pugh scores.||||0.002
91495291|NCT01852110|182862522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.7623|TWO_SIDED|95.0|-1.0|1.37|||Constrained Longitudinal Data Analysis|||||1.37|-1.00|0.7623
91495292|NCT01852110|182862526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9604|TWO_SIDED|95.0|-2.42|2.54|||Constrained Longitudinal Data Analysis|||||2.54|-2.42|0.9604
91495293|NCT01852110|182862527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.0829|TWO_SIDED|95.0|-0.01|0.22|||Constrained Longitudinal Data Analysis|||||0.22|-0.01|0.0829
91495294|NCT00279591|182862539|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Fisher Exact|||||||0.03
91495295|NCT00903695|182862543|SUPERIORITY_OR_OTHER|||||||0.8133||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio = 0.06, t-test = -0.25."||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.8133
91495296|NCT00903695|182862544|SUPERIORITY_OR_OTHER|||||||0.31||||||a priori threshold for statistical sginficance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio=1.22, t-test=1.1"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.31
91495297|NCT00903695|182862545|SUPERIORITY_OR_OTHER|||||||0.27||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.5, t-test = -1.23"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.27
91734116|NCT02231580|183362196|SUPERIORITY_OR_OTHER||GLS mean ratio|0.966|||=|0.8036|TWO_SIDED|90.0|0.765|1.22|||MMRM|||Right finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.220|0.765|=0.8036
91734117|NCT02231580|183362197|SUPERIORITY_OR_OTHER||GLS mean ratio|0.812|||=|0.0177|TWO_SIDED|90.0|0.706|0.935|||MMRM|||Left finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.935|0.706|=0.0177
91734118|NCT02231580|183362197|SUPERIORITY_OR_OTHER||GLS mean ratio|0.967|||=|0.6491|TWO_SIDED|90.0|0.856|1.093|||MMRM|||Right finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.093|0.856|=0.6491
91734119|NCT02231580|183362198|SUPERIORITY_OR_OTHER||GLS mean ratio|1.168|||=|0.6176|TWO_SIDED|90.0|0.697|1.955|||MMRM|||Left hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.955|0.697|=0.6176
91734120|NCT02231580|183362198|SUPERIORITY_OR_OTHER||GLS mean ratio|0.759|||=|0.4541|TWO_SIDED|90.0|0.411|1.399|||MMRM|||Right hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.399|0.411|=0.4541
91734121|NCT02231580|183362198|SUPERIORITY_OR_OTHER||GLS mean ratio|1.119|||=|0.2018|TWO_SIDED|90.0|0.967|1.294|||MMRM|||Left hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.294|0.967|=0.2018
91734122|NCT02231580|183362198|SUPERIORITY_OR_OTHER||GLS mean ratio|1.046|||=|0.6527|TWO_SIDED|90.0|0.886|1.234|||MMRM|||Right hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.234|0.886|=0.6527
91734123|NCT02231580|183362199|SUPERIORITY_OR_OTHER||GLS mean ratio|0.929|||=|0.8279|TWO_SIDED|90.0|0.529|1.63|||MMRM|||Left hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.630|0.529|=0.8279
91734124|NCT02231580|183362199|SUPERIORITY_OR_OTHER||GLS mean ratio|0.612|||=|0.2738|TWO_SIDED|90.0|0.292|1.283|||MMRM|||Right hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.283|0.292|=0.2738
91734125|NCT02231580|183362199|SUPERIORITY_OR_OTHER||GLS mean ratio|1.018|||=|0.9218|TWO_SIDED|90.0|0.752|1.378|||MMRM|||Left hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.378|0.752|=0.9218
91734126|NCT02231580|183362199|SUPERIORITY_OR_OTHER||GLS mean ratio|0.847|||=|0.5032|TWO_SIDED|90.0|0.561|1.277|||MMRM|||Right hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.277|0.561|=0.5032
91734127|NCT02231580|183362200|SUPERIORITY_OR_OTHER||GLS mean ratio|1.14|||=|0.6759|TWO_SIDED|90.0|0.677|1.917|||MMRM|||Left hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.917|0.677|=0.6759
91734128|NCT02231580|183362200|SUPERIORITY_OR_OTHER||GLS mean ratio|0.815|||=|0.5764|TWO_SIDED|90.0|0.444|1.496|||MMRM|||Right hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.496|0.444|=0.5764
91734129|NCT02231580|183362200|SUPERIORITY_OR_OTHER||GLS mean ratio|1.115|||=|0.2127|TWO_SIDED|90.0|0.965|1.289|||MMRM|||Left hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.289|0.965|=0.2127
91495298|NCT00903695|182862546|SUPERIORITY_OR_OTHER|||||||0.24||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.7, t-test = 1.3"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.24
91529912|NCT04147260|182936101|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.757|TWO_SIDED|90.0|-0.09|0.06||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.06|-0.09|0.757
91734130|NCT02231580|183362200|SUPERIORITY_OR_OTHER||GLS mean ratio|1.059|||=|0.5661|TWO_SIDED|90.0|0.897|1.25|||MMRM|||Right hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.25|0.897|=0.5661
91734131|NCT02231580|183362201|SUPERIORITY_OR_OTHER||GLS mean ratio|1.571|||=|0.0874|TWO_SIDED|90.0|1.018|2.424|||MMRM|||Left hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.424|1.018|=0.0874
91734132|NCT02231580|183362201|SUPERIORITY_OR_OTHER||GLS mean ratio|1.18|||=|0.6431|TWO_SIDED|90.0|0.644|2.162|||MMRM|||Right hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.162|0.644|=0.6431
91734133|NCT02231580|183362201|SUPERIORITY_OR_OTHER||GLS mean ratio|1.193|||=|0.0389|TWO_SIDED|90.0|1.038|1.371|||MMRM|||Left hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.371|1.038|=0.0389
91734134|NCT02231580|183362201|SUPERIORITY_OR_OTHER||GLS mean ratio|1.138|||=|0.1641|TWO_SIDED|90.0|0.976|1.327|||MMRM|||Right hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.327|0.976|=0.1641
91734135|NCT02231580|183362202|SUPERIORITY_OR_OTHER||GLS mean ratio|0.93|||=|0.5668|TWO_SIDED|90.0|0.755|1.147|||MMRM|||Left hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.147|0.755|=0.5668
91734136|NCT02231580|183362202|SUPERIORITY_OR_OTHER||GLS mean ratio|0.978|||=|0.8686|TWO_SIDED|90.0|0.778|1.229|||MMRM|||Right hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.778|=0.8686
91529913|NCT04147260|182936101|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.049||0.158|TWO_SIDED|90.0|-0.17|0.03||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.03|-0.17|0.158
91734137|NCT02231580|183362203|SUPERIORITY_OR_OTHER||GLS mean ratio|0.879|||=|0.1244|TWO_SIDED|90.0|0.765|1.009|||MMRM|||Left hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.009|0.765|=0.1244
91734138|NCT02231580|183362203|SUPERIORITY_OR_OTHER||GLS mean ratio|0.919|||=|0.3535|TWO_SIDED|90.0|0.789|1.069|||MMRM|||Right hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.069|0.789|=0.3535
91734139|NCT02231580|183362204|SUPERIORITY_OR_OTHER||GLS mean ratio|2.163|||=|0.015|TWO_SIDED|90.0|1.295|3.614|||MMRM|||Left foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.614|1.295|=0.015
91734140|NCT02231580|183362204|SUPERIORITY_OR_OTHER||GLS mean ratio|1.274|||=|0.5136|TWO_SIDED|90.0|0.688|2.361|||MMRM|||Right foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.361|0.688|=0.5136
91529914|NCT04147260|182936101|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|90.0|-0.12|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.12|
91734141|NCT02231580|183362204|SUPERIORITY_OR_OTHER||GLS mean ratio|1.56|||=|0.0218|TWO_SIDED|90.0|1.139|2.137|||MMRM|||Left foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.137|1.139|=0.0218
91734142|NCT02231580|183362204|SUPERIORITY_OR_OTHER||GLS mean ratio|1.251|||=|0.372|TWO_SIDED|90.0|0.825|1.899|||MMRM|||Right foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.899|0.825|=0.3720
91734143|NCT02231580|183362205|SUPERIORITY_OR_OTHER||GLS mean ratio|1.911|||=|0.915|TWO_SIDED|90.0|1.017|3.592|||MMRM|||Left foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.592|1.017|=0.915
91734144|NCT02231580|183362205|SUPERIORITY_OR_OTHER||GLS mean ratio|1.687|||=|0.2745|TWO_SIDED|90.0|0.762|3.737|||MMRM|||Right foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|0.762|=0.2745
91734145|NCT02231580|183362205|SUPERIORITY_OR_OTHER||GLS mean ratio|1.598|||=|0.1148|TWO_SIDED|90.0|0.98|2.608|||MMRM|||Left foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.608|0.980|=0.1148
91734146|NCT02231580|183362205|SUPERIORITY_OR_OTHER||GLS mean ratio|1.454|||=|0.308|TWO_SIDED|90.0|0.789|2.679|||MMRM|||Right foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.679|0.789|=0.3080
91734147|NCT02231580|183362206|SUPERIORITY_OR_OTHER||GLS mean ratio|2.272|||=|0.0079|TWO_SIDED|90.0|1.381|3.737|||MMRM|||Left foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|1.381|=0.0079
91734148|NCT02231580|183362206|SUPERIORITY_OR_OTHER||GLS mean ratio|1.21|||=|0.0204|TWO_SIDED|90.0|0.686|2.133|||MMRM|||Right foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.133|0.686|=0.0204
91734149|NCT02231580|183362206|SUPERIORITY_OR_OTHER||GLS mean ratio|1.564|||=|0.0204|TWO_SIDED|90.0|1.144|2.138|||MMRM|||Left foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.138|1.144|=0.0204
91734150|NCT02231580|183362206|SUPERIORITY_OR_OTHER||GLS mean ratio|1.269|||=|0.3144|TWO_SIDED|90.0|0.856|1.884|||MMRM|||Right foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.884|0.856|=0.3144
91734151|NCT02231580|183362207|SUPERIORITY_OR_OTHER||GLS mean ratio|1.914|||=|0.0324|TWO_SIDED|90.0|1.167|3.141|||MMRM|||Left foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.141|1.167|=0.0324
91734152|NCT02231580|183362207|SUPERIORITY_OR_OTHER||GLS mean ratio|1.462|||=|0.246|TWO_SIDED|90.0|0.85|2.515|||MMRM|||Right foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.515|0.85|=0.246
91529915|NCT04147260|182936101|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.083||0.33|TWO_SIDED|90.0|-0.09|0.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.25|-0.09|0.330
91529916|NCT04147260|182936101|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.113||0.754|TWO_SIDED|90.0|-0.26|0.19||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.19|-0.26|0.754
91495299|NCT00903695|182862547|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 0.15, t-test = 0.39"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.71
91734153|NCT02231580|183362207|SUPERIORITY_OR_OTHER||GLS mean ratio|1.387|||=|0.1057|TWO_SIDED|90.0|0.994|1.935|||MMRM|||Left foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.935|0.994|=0.1057
91734154|NCT02231580|183362207|SUPERIORITY_OR_OTHER||GLS mean ratio|1.074|||=|0.7342|TWO_SIDED|90.0|0.758|1.523|||MMRM|||Right foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.523|0.758|=0.7342
91734155|NCT02231580|183362208|SUPERIORITY_OR_OTHER||GLS mean ratio|1.392|||=|0.1027|TWO_SIDED|90.0|0.997|1.943|||MMRM|||Left foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.943|0.997|=0.1027
91734156|NCT02231580|183362208|SUPERIORITY_OR_OTHER||GLS mean ratio|1.158|||=|0.4494|TWO_SIDED|90.0|0.84|1.595|||MMRM|||Right foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.595|0.840|=0.4494
91734157|NCT02231580|183362209|SUPERIORITY_OR_OTHER||GLS mean ratio|0.699|||=|0.035|TWO_SIDED|90.0|0.53|0.922|||MMRM|||Left foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.922|0.530|=0.0350
91734158|NCT02231580|183362209|SUPERIORITY_OR_OTHER||GLS mean ratio|0.853|||=|0.3556|TWO_SIDED|90.0|0.64|1.136|||MMRM|||Right foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.136|0.640|=0.3556
91734159|NCT01380080|183362238|SUPERIORITY_OR_OTHER_LEGACY||Cumulative probability difference|-0.06||||0.97|TWO_SIDED|95.0|-3.05|2.94|||z-test|||Treatment comparison was made using the difference (arm B- arm A) in the Kaplan-Meier estimate for 24 week cumulative probability of death or unknown vital status with 95% confidence interval||2.94|-3.05|0.97
91734160|NCT02303821|183362265|OTHER||||||||||||||||||The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).|||
91734161|NCT02303821|183362266|OTHER||||||||||||||||||The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270).|||
91734162|NCT02303821|183362267|OTHER||||||||||||||||||The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).|||
91734163|NCT02303821|183362268|OTHER||||||||||||||||||The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).|||
91734164|NCT02303821|183362280|OTHER||||||||||||||||||The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval \[CI\]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31).|||
91734165|NCT00210132|183362281|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of proportions.||||0.99
91734166|NCT00210132|183362282|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91495300|NCT00903695|182862548|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 2.25, ttest = -1.5"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.18
91734167|NCT00057577|183362373|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Subdistribution hazard model|||||||=.038
91734168|NCT00057577|183362374|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Subdistribution hazard model|||||||<0.01
91734169|NCT00937105|183362393|SUPERIORITY_OR_OTHER||Cumulative Probability of no-CIE|92.8|||||TWO_SIDED|95.0|88.6|96.9|||Kaplan-Meier|Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim||Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort||96.9|88.6|
91495301|NCT00903695|182862549|SUPERIORITY_OR_OTHER|||||||0.34||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.06, t-test = -1.03"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.34
91734170|NCT00937105|183362394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.737||||0.3923|TWO_SIDED|95.0|0.49|6.156|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial lens bioburden|To determine if microbial contamination of lenses is a risk factor for CIE||6.156|0.49|0.3923
91734171|NCT00937105|183362395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7943|TWO_SIDED|95.0|0.167|10.393|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no corneal staining|||10.393|0.167|0.7943
91734172|NCT00937105|183362396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.674||||0.5894|TWO_SIDED|95.0|0.161|2.822|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial case bioburden|||2.822|0.161|0.5894
91734173|NCT00937105|183362397|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.406||||0.1742|TWO_SIDED|95.0|0.678|8.537||Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|Regression, Cox||referent is no substantial overall lid bioburden|||8.537|0.678|0.1742
91734174|NCT00937105|183362398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.22||||0.04|TWO_SIDED|95.0|1.1|24.7|||Regression, Cox|Multivariate model adjusted for solution, gender and age|referent is no substantial CNS lid bioburden|||24.70|1.10|0.04
91734175|NCT04983979|183362399|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.752|0.552||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.552|-0.752|
91734176|NCT04983979|183362400|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.97|0.65|||||Only the mean difference for the study end (week 12) is presented here|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.65|-1.97|
91734177|NCT04983979|183362401|OTHER||Mean Difference (Final Values)|25.15|||||TWO_SIDED|95.0|-48.83|99.13|||||Difference in change in systolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||99.13|-48.83|
91734178|NCT04983979|183362401|OTHER||Mean Difference (Final Values)|8.78|||||TWO_SIDED|95.0|-22.92|40.47|||||Difference in change in diastolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||40.47|-22.92|
91495302|NCT01549860|182862550|SUPERIORITY_OR_OTHER||||||<|0.024|TWO_SIDED||||||t-test, 2 sided|||||||<0.024
91495303|NCT01549860|182862552|SUPERIORITY_OR_OTHER||||||<|0.0126|TWO_SIDED|||||The MIST+SOC subjects decreased in their reported mean pain scores and reduced from a median of 3.0 to 0.6 cm after four weeks of study treatment.|ANCOVA|||||||<0.0126
91734179|NCT04983979|183362402|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
91495304|NCT01599234|182862652|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.23||||0.22||95.0|-0.59|0.14|||ANCOVA|||The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.||0.14|-0.59|0.220
91495305|NCT01599234|182862653|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.341||||0.231|TWO_SIDED|95.0|0.83|2.167|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.167|0.830|0.231
91495306|NCT01599234|182862654|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.16||||0.857|TWO_SIDED|95.0|-1.94|1.61|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.61|-1.94|0.857
91734180|NCT04983979|183362403|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.00|0.00|
91734181|NCT04983979|183362404|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
91734182|NCT04983979|183362405|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-19.5|11.4||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||11.4|-19.5|
91734183|NCT03176173|183362419|SUPERIORITY|||||||0.0007|||||||Exact binomial test|||||||0.0007
91734184|NCT03941093|183362488|OTHER||Hazard Ratio (HR)|1.08||||0.5487|TWO_SIDED|95.0|0.83|1.41|||Stratified Log Rank Test|||||1.41|0.83|0.5487
91734185|NCT05847686|183362503|OTHER||||||<|0.0001|||||||t-test, 1 sided|||||||<.0001
91734186|NCT05395936|183362513|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91734187|NCT04795531|183362514|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment, region and sulfonylureas (SU)/glinides use as fixed factors, and baseline response as covariate.||-0.08|-0.34|<0.0001
91734188|NCT00582907|183362595|SUPERIORITY_OR_OTHER||Risk Ratio, log|-1.7|STANDARD_DEVIATION|0.78||0.027|TWO_SIDED|95.0|-3.4|-0.1|||Signed rank|||Based upon FMF colchicine controlled studies showing an \~80% decrease in attacks, we estimated, based on baseline attacks every 4 weeks, there would be a difference of 0.5 attacks per month between rilonacept and placebo. With a two-sided 5% significance level and power of 80% we aimed for 14 evaluable participants who completed at least 2 treatment courses. The null hypothesis is that there would be no significant differences in the number of attacks between use of rilonacept and placebo.||-0.1|-3.4|0.027
91734189|NCT00582907|183362595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|STANDARD_DEVIATION|0.12||||95.0|0.39|0.85|||Bayesian modeling||Attacks while receiving rilonacept is the numerator and attacks while receiving placebo is the denominator. In Bayesian statistics credible interval equals confidence interval.|This analysis was done by Bayesian Statistics using a non-informative (neutral) prior (log normal distribution mean 9 \[SD 10\]). The null hypothesis was that the rilonacept/placebo FMF odds ratio of attacks was 1.||0.85|0.39|
91734190|NCT00582907|183362596|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|1.26||0.047|TWO_SIDED|95.0|-4.0|0.0|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of injection site reactions. No power calculations for this outcome.||0|-4|0.047
91734191|NCT00582907|183362596|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.13|TWO_SIDED|95.0|-0.56|0.17|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of infections. No power calculations for this outcome.||0.17|-0.56|0.13
91734192|NCT00582907|183362597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|0.5||0.32||95.0|-2.4|0.5|||Signed rank|||Null hypothesis: There were no significant differences in the length of attacks during rilonacept vs. placebo treatment courses. Since this was a secondary outcome there were no power calculations performed.||0.5|-2.4|0.32
91734193|NCT00582907|183362598|SUPERIORITY_OR_OTHER||Differences in percent of courses|29.0||||0.004||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses without attacks between rilonacept and placebo. As a secondary measure there were no power calculations.||||0.004
91734194|NCT00582907|183362599|SUPERIORITY_OR_OTHER||Difference in percent of courses|40.0||||0.006||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses attaining at least a 50% decrease in attacks when compared to baseline between rilonacept and placebo courses.Since this was a secondary measure there were no power calculations.||||0.006
91734195|NCT00582907|183362600|SUPERIORITY_OR_OTHER||Log Rank|0.009||||0.009||95.0|||||Kaplan-Meier survival analysis|||Null hypothesis: There were no significant differences between rilonacept and placebo in the number of days from the start of the treatment course until the development of the a second attack.||||0.009
91734196|NCT00582907|183362601|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.5||||0.156|TWO_SIDED|95.0|-0.5|12.5|||Signed Rank|||Null hypothesis: There are no significant differences in the erythrocyte sedimentation rate between rilonacept and placebo. As a secondary measure there were no power calculations.||12.5|-0.5|0.156
91734197|NCT00582907|183362602|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.04||||0.22|TWO_SIDED|95.0|-0.03|0.29|||Signed Rank|||Null hypothesis: There are no differences in the C-reactive protein levels between the treatment courses. Since this was a secondary outcome measure no power calculations were performed.||0.29|-0.03|0.22
91734198|NCT00582907|183362603|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.4||||0.078|TWO_SIDED|95.0|0.4|78.1|||Signed Rank|||Null hypothesis: There were no differences between the platelet count between the rilonacept and placebo courses. Since this was a secondary outcome no power calculations were performed.||78.1|0.4|0.078
91734199|NCT00582907|183362604|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.0||||0.063|TWO_SIDED|95.0|6.5|139.5|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the fibrinogen level. Since this was a secondary outcome no power calculations were performed.||139.5|6.5|0.063
91734200|NCT00582907|183362605|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5|TWO_SIDED|95.0|-4.0|0.0|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the serum amyloid A levels. Since this was a secondary outcome no power calculations were performed.||0|-4|0.50
91734201|NCT00582907|183362606|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.5||||0.021|TWO_SIDED|95.0|-11.1|-2.3|||Signed rank|||Null hypothesis: There are no significant differences in the physical health-related quality of life between rilonacept and placebo. As a secondary measure there were no power calculations.||-2.3|-11.1|0.021
91734202|NCT00582907|183362606|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.2||||0.42|TWO_SIDED|95.0|-6.8|3.9|||Signed Rank|||||3.9|-6.8|0.42
91734203|NCT00582907|183362607|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.136|TWO_SIDED|95.0|-2.3|9.8|||Signed rank|||Null hypothesis: There are no significant differences in the FMF Armenian Evaluation (severity) Score between rilonacept and placebo. As a secondary measure there were no power calculations.||9.8|-2.3|0.136
91734204|NCT00582907|183362608|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.0||||0.089|TWO_SIDED|95.0|-15.0|-1.0|||Signed rank|||Null hypothesis: There are no significant differences in the proportion of time participants were treated with rilonacept and placebo. As a secondary measure there were no power calculations.||-1|-15|0.089
91495307|NCT01599234|182862655|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.07||||0.734|TWO_SIDED|95.0|-0.55|0.4|||ANCOVA|||The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||0.40|-0.55|0.734
91734205|NCT00189423|183362656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.019|TWO_SIDED|95.0|1.07|2.36|||Fisher Exact|||||2.36|1.07|0.019
91734206|NCT00189423|183362657|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 5%||||||0.0001|TWO_SIDED|95.0||||p value is for non-inferiority with a margin of 5% (exact binomial test)|Fisher Exact test, for non-inferiority|||||||0.0001
91734207|NCT00189423|183362657|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED|95.0|||||Fisher Exact|||||||0.681
91734208|NCT00189423|183362663|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||Fisher Exact|||||||0.024
91734209|NCT01263119|183362669|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.07|||||TWO_SIDED|90.0|1.0|1.13|||Mixed Models Analysis|||||1.13|1.00|
91734210|NCT01263119|183362670|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.07|1.16|||Mixed Models Analysis|||||1.16|1.07|
91734211|NCT01263119|183362671|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9551|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.9551
91495308|NCT01599234|182862657|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.0||||0.624|TWO_SIDED|95.0|-2.0|1.0|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.0|-2.0|0.624
91734212|NCT01263119|183362672|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.15|||||TWO_SIDED|90.0|1.1|1.2|||Mixed Models Analysis|||||1.20|1.10|
91734213|NCT01263119|183362673|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.13|||||TWO_SIDED|90.0|1.09|1.17|||Mixed Models Analysis|||||1.17|1.09|
91734214|NCT01263119|183362674|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6094|TWO_SIDED|90.0|-0.5|0.02|||Wilcoxon (Mann-Whitney)|||||0.02|-0.50|0.6094
91734215|NCT01263119|183362675|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.02|1.05|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.||1.05|1.02|
91734216|NCT01263119|183362676|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.08|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.||1.08|1.01|
91734217|NCT02138825|183362677|SUPERIORITY_OR_OTHER||LS mean difference|21.48||||0.2074|TWO_SIDED|95.0|-8.75|51.71|||ANCOVA|||The evaluation of primary efficacy endpoint will be based on change from baseline in 6MWD using analysis of covariance (ANCOVA) with baseline 6MWD, treatment arm and region as factors.||51.71|-8.75|0.2074
91734218|NCT02138825|183362678|SUPERIORITY_OR_OTHER|||||||0.3437|||||||Mantel Haenszel|||The difference in incidences in clinical worsening and mortality will be analyzed using Mantel-Haenszel weights, stratified by region.||||0.3437
91734219|NCT01690273|183362685|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
91734220|NCT01690273|183362685|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91734221|NCT01690273|183362685|SUPERIORITY_OR_OTHER|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91734222|NCT01690273|183362685|SUPERIORITY_OR_OTHER|||||||0.9913|||||||Mixed Models Analysis|||||||0.9913
91734223|NCT01690273|183362685|SUPERIORITY_OR_OTHER|||||||0.0427|||||||Mixed Models Analysis|||||||0.0427
91734224|NCT01690273|183362685|SUPERIORITY_OR_OTHER|||||||0.1856|||||||Mixed Models Analysis|||||||0.1856
91734225|NCT01690273|183362686|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
91734226|NCT01690273|183362686|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
91734227|NCT01690273|183362686|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
91734228|NCT01690273|183362686|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734229|NCT01690273|183362686|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
91734230|NCT01690273|183362686|SUPERIORITY_OR_OTHER|||||||0.876|||||||Mixed Models Analysis|||||||0.876
91734231|NCT01690273|183362687|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91734232|NCT01690273|183362687|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|||||||0.87
91734233|NCT01690273|183362687|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
91734234|NCT01690273|183362687|SUPERIORITY_OR_OTHER|||||||0.989|||||||Mixed Models Analysis|||||||0.989
91734235|NCT01690273|183362687|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
91734236|NCT01690273|183362687|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
91734237|NCT01690273|183362688|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91734238|NCT01690273|183362688|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91734239|NCT01690273|183362688|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||0.94
91734240|NCT01690273|183362688|SUPERIORITY_OR_OTHER|||||||0.213|||||||Mixed Models Analysis|||||||0.213
91734241|NCT01690273|183362688|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91734242|NCT01690273|183362688|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
91734243|NCT01690273|183362689|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
91734244|NCT01690273|183362689|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91734245|NCT01690273|183362689|SUPERIORITY_OR_OTHER|||||||0.69|||||||Mixed Models Analysis|||||||0.69
91734246|NCT01690273|183362689|SUPERIORITY_OR_OTHER|||||||0.874|||||||Mixed Models Analysis|||||||0.874
91734247|NCT01690273|183362689|SUPERIORITY_OR_OTHER|||||||0.057|||||||Mixed Models Analysis|||||||0.057
91734248|NCT01690273|183362689|SUPERIORITY_OR_OTHER|||||||0.526|||||||Mixed Models Analysis|||||||0.526
91734249|NCT01690273|183362690|SUPERIORITY_OR_OTHER|||||||0.853|||||||Mixed Models Analysis|||||||0.853
91734250|NCT01690273|183362690|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
91734251|NCT01690273|183362690|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
91734252|NCT01690273|183362690|SUPERIORITY_OR_OTHER|||||||0.889|||||||Mixed Models Analysis|||||||0.889
91734253|NCT01690273|183362690|SUPERIORITY_OR_OTHER|||||||0.098|||||||Mixed Models Analysis|||||||0.098
91734254|NCT01690273|183362690|SUPERIORITY_OR_OTHER|||||||0.645|||||||Mixed Models Analysis|||||||0.645
91734255|NCT01690273|183362691|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
91734256|NCT01690273|183362691|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
91734257|NCT01690273|183362691|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
91734258|NCT01690273|183362691|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734259|NCT01690273|183362691|SUPERIORITY_OR_OTHER|||||||0.338|||||||Mixed Models Analysis|||||||0.338
91734260|NCT01690273|183362691|SUPERIORITY_OR_OTHER|||||||0.476|||||||Mixed Models Analysis|||||||0.476
91734261|NCT01690273|183362692|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
91734262|NCT01690273|183362692|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91734263|NCT01690273|183362692|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734264|NCT01690273|183362692|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734265|NCT01690273|183362692|SUPERIORITY_OR_OTHER|||||||0.995|||||||Mixed Models Analysis|||||||0.995
91734266|NCT01690273|183362692|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|||||||0.985
91734267|NCT01690273|183362693|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.9
91495309|NCT01599234|182862658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.248||||0.27|TWO_SIDED|95.0|0.842|1.849|||Regression, Logistic|||The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.||1.849|0.842|0.270
91734268|NCT01690273|183362693|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.7
91734269|NCT01690273|183362693|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91734270|NCT01690273|183362693|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
91734271|NCT01690273|183362693|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
91734272|NCT01690273|183362693|SUPERIORITY_OR_OTHER|||||||0.739|||||||Mixed Models Analysis|||||||0.739
91734273|NCT01690273|183362694|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734274|NCT01690273|183362694|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734275|NCT01690273|183362694|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|||||||0.37
91734276|NCT01690273|183362694|SUPERIORITY_OR_OTHER|||||||0.618|||||||Mixed Models Analysis|||||||0.618
91734277|NCT01690273|183362694|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734278|NCT01690273|183362694|SUPERIORITY_OR_OTHER|||||||0.689|||||||Mixed Models Analysis|||||||0.689
91734279|NCT01690273|183362695|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||0.8
91734280|NCT01690273|183362695|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
91734281|NCT01690273|183362695|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91495310|NCT01599234|182862659|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.15||||0.867|TWO_SIDED|95.0|-1.95|1.64|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.64|-1.95|0.867
91495311|NCT01599234|182862660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.215||||0.569|TWO_SIDED|95.0|0.622|2.373|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.373|0.622|0.569
91734282|NCT01690273|183362695|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
91513326|NCT00360334|182898209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.191||95.0|0.42|1.19|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.19|0.42|0.191
91734283|NCT01690273|183362695|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|||||||0.929
91734284|NCT01690273|183362695|SUPERIORITY_OR_OTHER|||||||0.98|||||||Mixed Models Analysis|||||||0.980
91734285|NCT01690273|183362696|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
91734286|NCT01690273|183362696|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
91734287|NCT01690273|183362696|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
91734288|NCT01690273|183362696|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
91734289|NCT01690273|183362696|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.970
91734290|NCT01690273|183362696|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
91734291|NCT01690273|183362697|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
91734292|NCT01690273|183362697|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
91734293|NCT01690273|183362697|SUPERIORITY_OR_OTHER|||||||0.503|||||||Mixed Models Analysis|||||||0.503
91734294|NCT01690273|183362697|SUPERIORITY_OR_OTHER|||||||0.814|||||||Mixed Models Analysis|||||||0.814
91734295|NCT01690273|183362697|SUPERIORITY_OR_OTHER|||||||0.643|||||||Mixed Models Analysis|||||||0.643
91734296|NCT01690273|183362697|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
91734297|NCT01690273|183362698|SUPERIORITY_OR_OTHER|||||||0.787|||||||Mixed Models Analysis|||||||0.787
91734298|NCT01690273|183362698|SUPERIORITY_OR_OTHER|||||||0.408|||||||Mixed Models Analysis|||||||0.408
91734299|NCT01690273|183362698|SUPERIORITY_OR_OTHER|||||||0.157|||||||Mixed Models Analysis|||||||0.157
91734300|NCT01690273|183362698|SUPERIORITY_OR_OTHER|||||||0.835|||||||Mixed Models Analysis|||||||0.835
91734301|NCT01690273|183362698|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||||||0.256
91734302|NCT01690273|183362698|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
91734303|NCT01690273|183362699|SUPERIORITY_OR_OTHER|||||||0.978|||||||Mixed Models Analysis|||||||0.978
91734304|NCT01690273|183362699|SUPERIORITY_OR_OTHER|||||||0.169|||||||Mixed Models Analysis|||||||0.169
91734305|NCT01690273|183362699|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91734306|NCT01690273|183362699|SUPERIORITY_OR_OTHER|||||||0.993|||||||Mixed Models Analysis|||||||0.993
91734307|NCT01690273|183362699|SUPERIORITY_OR_OTHER|||||||0.105|||||||Mixed Models Analysis|||||||0.105
91734308|NCT01690273|183362699|SUPERIORITY_OR_OTHER|||||||0.335|||||||Mixed Models Analysis|||||||0.335
91513327|NCT00360334|182898210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.363||95.0|0.66|3.07|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||3.07|0.66|0.363
91734309|NCT01383005|183362719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.001|TWO_SIDED|95.0|0.052|0.494|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from detectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'detectable to undetectable' in the last model of the Wald test.||0.494|0.052|0.001
91734310|NCT01383005|183362719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.279||||0.072|TWO_SIDED|95.0|0.07|1.118|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from undetectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 2 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' in the last model of the Wald test.||1.118|0.070|0.072
91734311|NCT01383005|183362720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.025|TWO_SIDED|95.0|0.992|0.999|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'time on LPV/r.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.||0.999|0.992|0.025
91734312|NCT02090764|183362748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Chi-squared|||The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.||||0.001
91734313|NCT02300233|183362751|SUPERIORITY||Difference in Least Squares Mean (LSM)|-70.3|||<|0.0001|TWO_SIDED|95.0|-85.4|-55.3|||ANCOVA|||||-55.3|-85.4|<0.0001
91734314|NCT02300233|183362752|SUPERIORITY||Difference in LSM|-943.0|||<|0.0001|TWO_SIDED|95.0|-1197.0|-689.0|||ANCOVA|||||-689|-1197|<0.0001
91734315|NCT02300233|183362753|SUPERIORITY||Odds Ratio (OR)|96.02|||<|0.0001|TWO_SIDED|95.0|19.71|467.79|||Regression, Logistic|||||467.79|19.71|<0.0001
91734316|NCT02300233|183362754|SUPERIORITY||Difference in LSM|56.8|||<|0.0001|TWO_SIDED|95.0|45.1|68.6|||ANCOVA|||||68.6|45.1|<0.0001
91734317|NCT02300233|183362755|SUPERIORITY||Odds Ratio (OR)|14.93||||0.0474|TWO_SIDED|95.0|1.03|215.88|||Regression, Logistic|||||215.88|1.03|0.0474
91734318|NCT00744861|183362797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|||||||Cochran-Mantel-Haenszel|site stratified||||||0.9905
91734319|NCT04752566|183362835|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.8938|TWO_SIDED|95.0|0.45|1.97||Log Rank Test stratified by randomization strata.|Log Rank||Cox proportional hazard model stratified by randomization strata, with treatment group as the fixed effect. Firth's adjustment was applied if no event was observed in a treatment group.|||1.97|0.45|0.8938
91734320|NCT04752566|183362836|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8987|TWO_SIDED|95.0|0.27|3.17|||Regression, Logistic|||Week 8||3.17|0.27|0.8987
91734321|NCT04752566|183362836|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4083|TWO_SIDED|95.0|0.18|2.02|||Regression, Logistic|||Week 24||2.02|0.18|0.4083
91734322|NCT04752566|183362837|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6739|TWO_SIDED|95.0|0.24|2.54|||Regression, Logistic|||||2.54|0.24|0.6739
91734323|NCT02038647|183362854|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.113|TWO_SIDED|95.0|0.557|1.067||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.067|0.557|0.113
91529917|NCT04147260|182936102|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|0.09|0.52|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.52|0.09|
91529918|NCT04147260|182936102|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.151|TWO_SIDED|90.0|-0.06|0.38||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.38|-0.06|0.151
91529919|NCT04147260|182936102|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.145||0.319|TWO_SIDED|90.0|-0.15|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.15|0.319
91529920|NCT04147260|182936102|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.04|0.42|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.42|-0.04|
91529921|NCT04147260|182936102|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.112||0.246|TWO_SIDED|90.0|-0.09|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.09|0.246
91529922|NCT04147260|182936102|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.704|TWO_SIDED|90.0|-0.25|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.25|0.704
91529923|NCT04147260|182936103|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.929||0.692|TWO_SIDED|90.0|-11.92|7.99||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.99|-11.92|0.692
91529924|NCT04147260|182936103|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.048||0.63|TWO_SIDED|90.0|-10.14|6.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||6.21|-10.14|0.630
91529925|NCT04147260|182936103|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.482||1|TWO_SIDED|90.0|-11.07|11.07||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.07|-11.07|1.000
91734324|NCT02038647|183362856|SUPERIORITY||Cox Proportional Hazard|0.93||||0.714|TWO_SIDED|95.0|0.652|1.341||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.341|0.652|0.714
91529926|NCT04147260|182936103|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|4.518||0.751|TWO_SIDED|90.0|-10.55|7.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.66|-10.55|0.751
91529927|NCT04147260|182936103|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|3.894||0.669|TWO_SIDED|90.0|-6.17|9.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.52|-6.17|0.669
91529928|NCT04147260|182936103|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|5.123||0.546|TWO_SIDED|90.0|-13.44|7.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.21|-13.44|0.546
91513328|NCT00360334|182898212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
91529929|NCT04147260|182936104|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-12.45|STANDARD_ERROR_OF_MEAN|11.385||0.281|TWO_SIDED|90.0|-35.44|10.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.54|-35.44|0.281
91529930|NCT04147260|182936104|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-16.14|STANDARD_ERROR_OF_MEAN|9.35||0.092|TWO_SIDED|90.0|-35.02|2.74||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.74|-35.02|0.092
91513329|NCT00360334|182898213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
91495312|NCT00869206|182862672|NON_INFERIORITY_OR_EQUIVALENCE|Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0|||||<=|0.05|||||||Cochran-Mantel-Haenszel|||||||<=.05
91513330|NCT00360334|182898214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
91495313|NCT00869206|182862673|SUPERIORITY_OR_OTHER||Slope|-0.00394|STANDARD_ERROR_OF_MEAN|0.00962||0.68|TWO_SIDED||||||Mixed Models Analysis|Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status||||||0.68
91495314|NCT00869206|182862674|SUPERIORITY_OR_OTHER||Slope|0.0016|STANDARD_ERROR_OF_MEAN|0.0034||0.64|TWO_SIDED||||||Mixed Models Analysis|Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status||||||0.64
91495315|NCT00869206|182862676|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.1|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.10
91495316|NCT03462082|182862702|SUPERIORITY|||||||0.163||||||"Holm-adjusted P-Value: 0.326~\*Gait Velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.163
91495317|NCT03462082|182862702|SUPERIORITY|||||||0.749||||||"Holm-adjusted P-Value: 0.749~\*Gait Velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.749
91495318|NCT03462082|182862703|SUPERIORITY|||||||0.031||||||"Holm-adjusted P-Value: 0.155~\*MDS-UPDRS (total) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.031
91529931|NCT04147260|182936104|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|12.662||0.772|TWO_SIDED|90.0|-21.88|29.27||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||29.27|-21.88|0.772
91529932|NCT04147260|182936104|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|13.255||0.539|TWO_SIDED|90.0|-34.93|18.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.50|-34.93|0.539
91529933|NCT04147260|182936104|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-4.71|STANDARD_ERROR_OF_MEAN|11.424||0.682|TWO_SIDED|90.0|-27.74|18.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.31|-27.74|0.682
91529934|NCT04147260|182936104|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|15.03||0.817|TWO_SIDED|90.0|-33.79|26.79||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||26.79|-33.79|0.817
91529935|NCT04147260|182936105|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|5.327||0.891|TWO_SIDED|90.0|-11.49|10.02||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.02|-11.49|0.891
91529936|NCT04147260|182936105|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|4.375||0.417|TWO_SIDED|90.0|-12.42|5.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.25|-12.42|0.417
91529937|NCT04147260|182936105|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|5.925||0.633|TWO_SIDED|90.0|-9.11|14.82||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.82|-9.11|0.633
91529938|NCT04147260|182936105|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|6.79|STANDARD_ERROR_OF_MEAN|4.384||0.129|TWO_SIDED|90.0|-2.05|15.62||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||15.62|-2.05|0.129
91734325|NCT02038647|183362857|SUPERIORITY||Odds Ratio (OR)|0.74||||0.406|TWO_SIDED|95.0|0.35|1.55||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using ORR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.55|0.35|0.406
91734326|NCT02038647|183362858|SUPERIORITY||Odds Ratio (OR)|0.01||||0.283|TWO_SIDED|95.0|0.01|9999.99||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using CRR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||9999.99|0.01|0.283
91734327|NCT02038647|183362859|SUPERIORITY||Odds Ratio (OR)|0.59||||0.077|TWO_SIDED|95.0|0.32|1.08||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using DCR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.08|0.32|0.077
91760030|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.54|-0.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.54|
91529939|NCT04147260|182936105|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.778||0.548|TWO_SIDED|90.0|-5.33|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-5.33|0.548
91529940|NCT04147260|182936105|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|4.97||0.37|TWO_SIDED|90.0|-5.51|14.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.52|-5.51|0.370
91529941|NCT04147260|182936106|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|10.379||0.375|TWO_SIDED|90.0|-30.26|11.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.66|-30.26|0.375
91529942|NCT04147260|182936106|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|8.524||0.185|TWO_SIDED|90.0|-28.7|5.73||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.73|-28.70|0.185
91734328|NCT01983111|183362889|NON_INFERIORITY_OR_EQUIVALENCE|In the PP set, for a non-inferiority test of the reduction in the pain intensity score from Visit 1 (Baseline) to Week 6 of treatment, the lower limit of the 97.5% onesided confidence interval was compared to a clinical non-inferiority margin, -1.5.|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|1.79||0.2658|TWO_SIDED|97.5|-6.0|3.0|||t-test, 2 sided|||In the Per protocol set||3|-6|0.2658
91734329|NCT03097289|183362929|NON_INFERIORITY|"The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: Null Hypothesis H0: μd ≤ 0 where μd=μT-0.66\*μC Alternate Hypothesis H1: μd \>~Let Xi = (XTi-0.66\*XCi) be a difference if recovery for patient i. The sample mean and standard deviations of these observed differences will be used to construct the lower limit of a 1-sided 97.5% confidence interval."|Mean Difference (Final Values)|8.18|||||ONE_SIDED|97.5|4.03||||||||||4.03|
91734330|NCT03097289|183362930|NON_INFERIORITY|"The acceptance criterion for the survival (days) of platelets is the demonstration of non inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses:~Null Hypothesis H0: μd ≤ 0 where μd = μT-0.58 × μC Alternate Hypothesis H1: μd \> 0"|Mean Difference (Final Values)|0.8|||||ONE_SIDED|97.5|0.39||||||||||0.39|
91734331|NCT00049543|183363009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.14|TWO_SIDED|95.0|0.94|1.64|||Log Rank|||The Kaplan-Meier estimates of survival distribution for overall survival by treatment arm are reported, and the log rank test stratified by the stratification factors at randomization (exclude center) was used to compare the difference in the overall survival between two treatment arms. Hazard ratio of comparison of study treatment arm to placebo and it 95% C.I. were reported.||1.64|0.94|0.14
91734332|NCT00049543|183363010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.15|TWO_SIDED|95.0|0.93|1.61||Stratified by stratification factors at randomization (except center)|Log Rank|Stratified by stratification factors at randomization (except center)||||1.61|0.93|0.15
91734333|NCT06203717|183363022|SUPERIORITY||Mean Difference (Net)|9.15|STANDARD_DEVIATION|10.06||0.007|TWO_SIDED|95.0|3.08|15.23||a priori threshold for statistical significance: p\<0.05|Paired-sample t-test|||||15.23|3.08|0.007
91734334|NCT06203717|183363023|SUPERIORITY||Mean Difference (Net)|7.77|STANDARD_DEVIATION|6.35||0.0009|TWO_SIDED|95.0|3.93|11.61|||Paired-sample t-test|||||11.61|3.93|0.0009
91734335|NCT05819398|183363053|OTHER||Difference of least square means|-20.4|STANDARD_ERROR_OF_MEAN|10.9|||TWO_SIDED|95.0|-41.9|1.1|||||Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.||1.1|-41.9|
91734336|NCT05819398|183363053|OTHER||Difference of least square means|-17.8|STANDARD_ERROR_OF_MEAN|11.0|||TWO_SIDED|95.0|-39.5|3.9|||||Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.||3.9|-39.5|
91734337|NCT05819398|183363053|OTHER||Difference of least square means|-4.3|STANDARD_ERROR_OF_MEAN|11.0|||TWO_SIDED|95.0|-26.0|17.5|||||Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.||17.5|-26.0|
91734338|NCT05819398|183363053|OTHER|||||||0.697||||||Adjusted p-value from multiple contrast test.|MCPMod Linear model|No assumptions.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.697
91734339|NCT05819398|183363053|OTHER|||||||0.844||||||Adjusted p-value from multiple contrast test.|MCPMod Exponential: model|Assumption: 30% of the maximum effect is achieved at the medium dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.844
91734340|NCT05819398|183363053|OTHER|||||||0.256||||||Adjusted p-value from multiple contrast test.|MCPMod Emax model|Assumption: 70% of the maximum effect is achieved at the medium dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.256
91734341|NCT05819398|183363053|OTHER|||||||0.571||||||Adjusted p-value from multiple contrast test.|MCPMod SigEmax model|Assumption: 70% of the maximum effect is achieved at the medium dose and 25% of the maximum effect is achieved at the low dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.571
91734342|NCT05819398|183363053|OTHER|||||||0.232||||||Adjusted p-value from multiple contrast test.|MCPMod BetaMod model|Assumption: 80% of the maximum effect is achieved at the medium dose and the maximum effect is achieved at the 70% of the high dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.232
91734343|NCT05819398|183363054|OTHER||Difference of least square means|-9.6|STANDARD_ERROR_OF_MEAN|15.0|||TWO_SIDED|95.0|-39.2|20.1|||||Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||20.1|-39.2|
91760031|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-0.81|-0.35||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.35|-0.81|
91495319|NCT03462082|182862703|SUPERIORITY|||||||0.778||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS total for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.778
91529943|NCT04147260|182936106|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|11.544||0.851|TWO_SIDED|90.0|-21.12|25.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||25.50|-21.12|0.851
91513331|NCT00360334|182898215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
91513332|NCT00360334|182898216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Repeated Measures|||||||<0.001
91529944|NCT04147260|182936106|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-26.64|STANDARD_ERROR_OF_MEAN|9.405||0.007|TWO_SIDED|90.0|-45.59|-7.69||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-7.69|-45.59|0.007
91529945|NCT04147260|182936106|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-15.01|STANDARD_ERROR_OF_MEAN|8.106||0.071|TWO_SIDED|90.0|-31.34|1.33||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||1.33|-31.34|0.071
91529946|NCT04147260|182936106|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.63|STANDARD_ERROR_OF_MEAN|10.664||0.281|TWO_SIDED|90.0|-33.13|9.86||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.86|-33.13|0.281
91529947|NCT04147260|182936107|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|5.37||0.599|TWO_SIDED|90.0|-13.69|8.0||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.00|-13.69|0.599
91529948|NCT04147260|182936107|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|4.41||0.824|TWO_SIDED|90.0|-7.92|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-7.92|0.824
91529949|NCT04147260|182936107|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.83|STANDARD_ERROR_OF_MEAN|5.973||0.525|TWO_SIDED|90.0|-15.9|8.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.23|-15.90|0.525
91529950|NCT04147260|182936107|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|6.867||0.25|TWO_SIDED|90.0|-21.84|5.84||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.84|-21.84|0.250
91529951|NCT04147260|182936107|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|5.919||0.386|TWO_SIDED|90.0|-6.74|17.12||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||17.12|-6.74|0.386
91529952|NCT04147260|182936107|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|7.787||0.097|TWO_SIDED|90.0|-28.88|2.51||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.51|-28.88|0.097
91529953|NCT04147260|182936108|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|6.842||0.885|TWO_SIDED|90.0|-12.83|14.81||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.81|-12.83|0.885
91529954|NCT04147260|182936108|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|28.9|STANDARD_ERROR_OF_MEAN|5.619|<|0.001|TWO_SIDED|90.0|17.55|40.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||40.25|17.55|<0.001
91529955|NCT04147260|182936108|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-27.91|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|90.0|-43.28|-12.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-12.54|-43.28|<0.001
91529956|NCT04147260|182936108|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-20.13|STANDARD_ERROR_OF_MEAN|8.041||0.016|TWO_SIDED|90.0|-36.33|-3.92||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-3.92|-36.33|0.016
91529957|NCT04147260|182936108|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|18.5|STANDARD_ERROR_OF_MEAN|6.931||0.011|TWO_SIDED|90.0|4.53|32.46||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||32.46|4.53|0.011
91529958|NCT04147260|182936108|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-38.62|STANDARD_ERROR_OF_MEAN|9.118|<|0.001|TWO_SIDED|90.0|-57.0|-20.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-20.25|-57.00|<0.001
91702396|NCT00772005|183299678|SUPERIORITY_OR_OTHER|||||||0.9355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9355
91529959|NCT02471404|182936131|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.0294|0.2986|||Mixed Models Analysis|||||0.2986|0.0294|
91529960|NCT02471404|182936131|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|-0.21||||0.001|TWO_SIDED|95.0|-0.3443|-0.0825||(superiority)|Mixed Models Analysis|||||-0.0825|-0.3443|0.001
91734344|NCT05819398|183363054|OTHER||Difference of least square means|-22.2|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|95.0|-52.0|7.6|||||Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||7.6|-52.0|
91734345|NCT05819398|183363054|OTHER||Difference of least square means|-8.8|STANDARD_ERROR_OF_MEAN|15.4|||TWO_SIDED|95.0|-39.1|21.6|||||Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||21.6|-39.1|
91734346|NCT05819398|183363055|OTHER||Difference of least square means|2.4|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-4.5|9.4|||||Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||9.4|-4.5|
91734347|NCT05819398|183363055|OTHER||Difference of least square means|-0.6|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-7.5|6.3|||||Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||6.3|-7.5|
91734348|NCT05819398|183363055|OTHER||Difference of least square means|3.0|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-3.9|10.0|||||Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||10.0|-3.9|
91734349|NCT05819398|183363055|OTHER|||||||0.887||||||Adjusted p-value from multiple contrast test.|MCPMod Linear model|No assumptions.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.887
91734350|NCT05819398|183363055|OTHER|||||||0.902||||||Adjusted p-value from multiple contrast test.|MCPMod Exponential: model|Assumption: 30% of the maximum effect is achieved at the medium dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.902
91734351|NCT05819398|183363055|OTHER|||||||0.866||||||Adjusted p-value from multiple contrast test.|MCPMod Emax model|Assumption: 70% of the maximum effect is achieved at the medium dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.866
91734352|NCT05819398|183363055|OTHER|||||||0.825||||||Adjusted p-value from multiple contrast test.|MCPMod SigEmax model|Assumption: 70% of the maximum effect is achieved at the medium dose and 25% of the maximum effect is achieved at the low dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.825
91734353|NCT05819398|183363055|OTHER|||||||0.634||||||Adjusted p-value from multiple contrast test.|MCPMod BetaMod model|Assumption: 80% of the maximum effect is achieved at the medium dose and the maximum effect is achieved at the 70% of the high dose.||Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.||||0.634
91734354|NCT05819398|183363056|OTHER||Difference of least square means|4.6|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-6.1|15.3|||||Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||15.3|-6.1|
91495320|NCT03462082|182862703|SUPERIORITY|||||||0.039||||||"Holm-adjusted P-Value: 0.157~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.039
91734355|NCT05819398|183363056|OTHER||Difference of least square means|-5.2|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-15.9|5.5|||||Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||5.5|-15.9|
91734356|NCT05819398|183363056|OTHER||Difference of least square means|7.6|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-3.3|18.5|||||Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)|The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.||18.5|-3.3|
91734357|NCT04887831|183363076|OTHER||Adjusted percentage difference|-0.101|STANDARD_ERROR_OF_MEAN|0.1052||0.34|TWO_SIDED|95.0|-0.308|0.105||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.105|-0.308|0.340
91734358|NCT04887831|183363077|OTHER||Adjusted percentage difference|-0.008|STANDARD_ERROR_OF_MEAN|0.1078||0.938|TWO_SIDED|95.0|-0.22|0.203||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.203|-0.220|0.938
91734359|NCT02180828|183363092|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.925|||||||Chi-squared|||||||0.925
91734360|NCT02180828|183363093|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.298|||||||Chi-squared|||||||0.298
91734361|NCT02180828|183363094|NON_INFERIORITY_OR_EQUIVALENCE|90% power and a two-sided alpha level of 0.05||||||0.147|||||||Chi-squared|||||||0.147
91734362|NCT02180828|183363095|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.147|||||||Chi-squared|||||||0.147
91734363|NCT02180828|183363096|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
91734364|NCT02180828|183363097|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
91734365|NCT02180828|183363098|SUPERIORITY_OR_OTHER|||||||0.658|||||||Chi-squared|||||||0.658
91734366|NCT02180828|183363099|SUPERIORITY_OR_OTHER|||||||0.123|||||||Chi-squared|||||||0.123
91734367|NCT02180828|183363100|SUPERIORITY_OR_OTHER|||||||0.274|||||||Chi-squared|||||||0.274
91734368|NCT03674281|183363123|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
91734369|NCT03674281|183363123|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91734370|NCT02448381|183363253|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
91513333|NCT00360334|182898217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.91||||0.001||95.0|3.7|210.54|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||210.54|3.70|0.001
91734371|NCT02448381|183363254|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
91734372|NCT02448381|183363255|SUPERIORITY|||||||0.046|||||||McNemar|||||||0.046
91734373|NCT02448381|183363256|SUPERIORITY||||||=|0.0009|||||||Fisher Exact|||||||=0.0009
91734374|NCT02448381|183363257|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91734375|NCT01137890|183363258|SUPERIORITY||F-value for main effect of Coc dose|24.9|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on VAQ score|||||<0.01
91734376|NCT01137890|183363258|SUPERIORITY||F-value for main effect of Zon dose|0.34||||0.72|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on VAQ score|||||0.72
91734377|NCT01137890|183363258|SUPERIORITY||F-value for main effect of Coc x Zon|0.66||||0.63|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine x Zonisamide interaction on VAQ scores|||||0.63
91734378|NCT01137890|183363259|SUPERIORITY||F-value for main effect of Coc dose|9.91|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on Behavioral Choice measure|||||<0.01
91734379|NCT01137890|183363259|SUPERIORITY||F-value for main effect of Zon dose|0.07||||0.93|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on Behavioral Choice measure|||||0.93
91734380|NCT01137890|183363259|SUPERIORITY||F-value for main effect of Coc x Zon|0.24||||0.92|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine dose x Zonisamide dose interaction on Behavioral Choice measure|||||0.92
91734381|NCT01137890|183363260|SUPERIORITY||t-value for main effect of Group|1.51||||0.16|TWO_SIDED|||||Group (Zonisamide vs Placebo)|t-test, 2 sided|||||||0.16
91734382|NCT01137890|183363260|SUPERIORITY|Day (Day 1-39)|t-value for main effect of Day|-3.2||||0.0015|TWO_SIDED||||||t-test, 2 sided|||||||0.0015
91734383|NCT01137890|183363260|SUPERIORITY|Group\*Day interaction|t value for Group x Day interaction|-1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
91734384|NCT01137890|183363261|SUPERIORITY||F-value for main effect of Coc dose|21.1|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose|||||<0.01
91734385|NCT01137890|183363261|SUPERIORITY||F-value for main effect of Zon dose|0.77||||0.48|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose|||||0.48
91734386|NCT01137890|183363261|SUPERIORITY||F-value for the main effect of Zon x Coc|0.93||||0.46|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide x Cocaine interaction on drug value (i.e., street value) measurement|||||0.46
91734387|NCT02621892|183363269|SUPERIORITY||Risk Difference (RD)|8.31|||<|0.02|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.02
91734388|NCT02621892|183363271|SUPERIORITY||Risk Difference (RD)|10.86|||<|0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.008
91529961|NCT02471404|182936132|SUPERIORITY||Risk Difference (RD)|-4.21|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-6.45|-1.97|||Fisher Exact|||||-1.97|-6.45|<0.001
91734389|NCT02621892|183363272|SUPERIORITY||Risk Difference (RD)|10.34|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91734390|NCT02621892|183363273|SUPERIORITY||Risk Difference (RD)|11.92|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91734391|NCT02621892|183363274|SUPERIORITY||Risk Difference (RD)|10.9|||<|0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.003
91734392|NCT02735200|183363275|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.9|TWO_SIDED|||||the p value correspond to the pretreatment time frame.|t-test, 2 sided|||||||0.9
91734393|NCT02735200|183363275|SUPERIORITY||Mean Difference (Final Values)|26.66|||<|0.001|TWO_SIDED|||||p value corresponds to the post treatment time frame.|t-test, 2 sided|||||||<0.001
91734394|NCT01838226|183363295|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.8|||Mixed Models Analysis|||||2.8|-1.3|0.50
91734395|NCT01838226|183363296|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-1.3|3.1|||Mixed Models Analysis|||||3.1|-1.3|
91734396|NCT01838226|183363297|SUPERIORITY||Mean Difference (Net)|-2.6|||||TWO_SIDED|95.0|-4.9|-0.2||||||||-0.2|-4.9|
91734397|NCT00023595|183363298|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.12|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.04|0.72|0.12
91734398|NCT00023595|183363299|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.02
91734399|NCT00023595|183363300|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.17|0.84|0.90
91734400|NCT00023595|183363301|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio, log|0.79||||0.006|TWO_SIDED|95.0|0.66|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.66|0.006
91734401|NCT00023595|183363302|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.05|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.00|0.66|0.05
91734402|NCT00023595|183363303|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.64|0.85|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.85|0.64|<0.001
91734403|NCT00023595|183363304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.64|0.82|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.82|0.64|<0.001
91734404|NCT00023595|183363305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.26|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.26|0.79|0.98
91734405|NCT00023595|183363306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.19||||0.008|TWO_SIDED|95.0|1.35|7.52|||Regression, Logistic||Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||7.52|1.35|0.008
91734406|NCT00023595|183363307|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.275|TWO_SIDED|95.0|0.78|2.41|||Regression, Logistic||Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||2.41|0.78|0.275
91734407|NCT00023595|183363308|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.03|TWO_SIDED|95.0|0.71|0.98|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.98|0.71|0.030
91529962|NCT02471404|182936132|SUPERIORITY||Risk Difference (RD)|-3.89|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|-6.21|-1.56|||Fisher Exact|||||-1.56|-6.21|<0.001
91529963|NCT02471404|182936133|SUPERIORITY||Mean Difference (Final Values)|-5.3|||<|0.001|TWO_SIDED|95.0|-5.93|-4.67|||Mixed Models Analysis|||||-4.67|-5.93|<0.001
91734408|NCT00023595|183363309|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.401|TWO_SIDED|95.0|0.89|1.31|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.31|0.89|0.401
91734409|NCT00023595|183363310|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.71|0.002
91734410|NCT00023595|183363326|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.71|0.51|<0.001
91734411|NCT00023595|183363327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.414|TWO_SIDED|95.0|0.73|1.13|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.13|0.73|0.414
91734412|NCT00023595|183363328|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.55|0.73|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.73|0.55|<0.001
91734413|NCT00023595|183363329|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.108|TWO_SIDED|95.0|0.72|1.03|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.03|0.72|0.108
91734414|NCT00023595|183363330|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.717|TWO_SIDED|95.0|0.83|1.32|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.32|0.83|0.717
91734415|NCT00023595|183363331|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.018|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.018
91734416|NCT00023595|183363347|SUPERIORITY|||||||0.015||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.015
91734417|NCT00023595|183363347|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
91734418|NCT00023595|183363347|SUPERIORITY|||||||0.011||||||24 months|Chi-squared|||||||0.011
91734419|NCT00023595|183363347|SUPERIORITY|||||||0.44||||||36 months|Chi-squared|||||||0.44
91734420|NCT00023595|183363348|SUPERIORITY|||||||0.91||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.91
91734421|NCT00023595|183363348|SUPERIORITY|||||||0.62||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.62
91734422|NCT00023595|183363348|SUPERIORITY|||||||0.04||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.04
91734423|NCT00023595|183363348|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91734424|NCT00023595|183363348|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91734425|NCT00023595|183363349|SUPERIORITY|||||||0.31||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.31
91734426|NCT00023595|183363349|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
91734427|NCT00023595|183363349|SUPERIORITY|24 months||||||0.028|||||||Chi-squared|||||||0.028
91734428|NCT00023595|183363349|SUPERIORITY|||||||0.079||||||36 months|Chi-squared|||||||0.079
91734429|NCT00023595|183363350|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
91734430|NCT00023595|183363350|SUPERIORITY|||||||0.61||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.61
91734431|NCT00023595|183363350|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91734432|NCT00023595|183363350|SUPERIORITY|||||||0.94||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.94
91734433|NCT00023595|183363350|SUPERIORITY|||||||0.29||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.29
91734434|NCT00023595|183363351|SUPERIORITY|||||||0.063||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.063
91734435|NCT00023595|183363351|SUPERIORITY|||||||0.187||||||12 months|Chi-squared|||||||0.187
91734436|NCT00023595|183363351|SUPERIORITY|||||||0.168||||||24 months|Chi-squared|||||||0.168
91734437|NCT00023595|183363351|SUPERIORITY|||||||0.05||||||36 months|Chi-squared|||||||0.050
91734438|NCT00023595|183363352|SUPERIORITY|||||||0.82||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.82
91734439|NCT00023595|183363352|SUPERIORITY|||||||0.48||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.48
91734440|NCT00023595|183363352|SUPERIORITY|||||||0.69||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.69
91734441|NCT00023595|183363352|SUPERIORITY|||||||0.63||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.63
91734442|NCT00023595|183363352|SUPERIORITY|||||||0.9||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.90
91734443|NCT00023595|183363353|SUPERIORITY|||||||0.039||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.039
91734444|NCT00023595|183363353|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
91734445|NCT00023595|183363353|SUPERIORITY|||||||0.008||||||24 months|Chi-squared|||||||0.008
91734446|NCT00023595|183363353|SUPERIORITY|||||||0.31||||||36 months|Chi-squared|||||||0.31
91734447|NCT00023595|183363354|SUPERIORITY|||||||0.36||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.36
91734448|NCT00023595|183363354|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
91734449|NCT00023595|183363354|SUPERIORITY|||||||0.17||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.17
91734450|NCT00023595|183363354|SUPERIORITY|||||||0.12||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.12
91734451|NCT00023595|183363354|SUPERIORITY|||||||0.79||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.79
91734452|NCT00023595|183363355|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|||||||<0.001
91734453|NCT00023595|183363355|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
91734454|NCT00023595|183363355|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
91734455|NCT00023595|183363355|SUPERIORITY||||||<|0.024||||||36 months|Chi-squared|||||||<0.024
91734456|NCT00023595|183363356|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
91734457|NCT00023595|183363356|SUPERIORITY|||||||0.42||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.42
91734458|NCT00023595|183363356|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
91734459|NCT00023595|183363356|SUPERIORITY|||||||0.32||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.32
91734460|NCT00023595|183363356|SUPERIORITY|||||||0.43||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.43
91734461|NCT00023595|183363357|SUPERIORITY|||||||0.051||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.051
91734462|NCT00023595|183363357|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
91734463|NCT00023595|183363357|SUPERIORITY|||||||0.065||||||24 months|Chi-squared|||||||0.065
91734464|NCT00023595|183363357|SUPERIORITY|||||||0.83||||||36 months|Chi-squared|||||||0.83
91734465|NCT00023595|183363358|SUPERIORITY|||||||0.71||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.71
91734466|NCT00023595|183363358|SUPERIORITY|||||||0.57||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.57
91734467|NCT00023595|183363358|SUPERIORITY|||||||0.15||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.15
91734468|NCT00023595|183363358|SUPERIORITY|||||||0.64||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.64
91734469|NCT00023595|183363358|SUPERIORITY|||||||0.07||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.07
91734470|NCT00023595|183363359|SUPERIORITY|||||||0.004||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.004
91734471|NCT00023595|183363359|SUPERIORITY|||||||0.011||||||12 months|Chi-squared|||||||0.011
91734472|NCT00023595|183363359|SUPERIORITY|||||||0.007||||||24 months|Chi-squared|||||||0.007
91734473|NCT00023595|183363359|SUPERIORITY|||||||0.044||||||36 months|Chi-squared|||||||0.044
91734474|NCT00023595|183363360|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
91734475|NCT00023595|183363360|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
91734476|NCT00023595|183363360|SUPERIORITY|||||||0.03||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.03
91734477|NCT00023595|183363360|SUPERIORITY|||||||0.6||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.60
91734478|NCT00023595|183363360|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
91495321|NCT03462082|182862703|SUPERIORITY|||||||0.451||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.451
91495322|NCT03462082|182862703|SUPERIORITY|||||||0.111||||||"Holm-adjusted P-Value: 0.333~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.111
91495323|NCT03462082|182862703|SUPERIORITY|||||||0.005||||||"Holm-adjusted P-Value: 0.030~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.005
91734479|NCT00023595|183363361|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
91734480|NCT00023595|183363361|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
91734481|NCT00023595|183363361|SUPERIORITY|24 months||||||0.049|||||||Chi-squared|||||||0.049
91734482|NCT00023595|183363361|SUPERIORITY|||||||0.097||||||36 months|Chi-squared|||||||0.097
91734483|NCT00023595|183363362|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
91734484|NCT00023595|183363362|SUPERIORITY|||||||0.13||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.13
91734485|NCT00023595|183363362|SUPERIORITY|||||||0.86||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.86
91495324|NCT03462082|182862704|SUPERIORITY|||||||0.984||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.984
91495325|NCT03462082|182862704|SUPERIORITY|||||||0.067||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.067
91734486|NCT00023595|183363362|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
91734487|NCT00023595|183363362|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
91734488|NCT00023595|183363363|SUPERIORITY|||||||0.005||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.005
91734489|NCT00023595|183363363|SUPERIORITY|||||||0.023||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.023
91513334|NCT00360334|182898219|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Model Repeated Measures|||||||0.014
91513335|NCT00360334|182898220|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Model Repeated Measures|||||||0.100
91734490|NCT00023595|183363363|SUPERIORITY|||||||0.009||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.009
91734491|NCT00023595|183363363|SUPERIORITY|||||||0.26||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.26
91734492|NCT00023595|183363364|SUPERIORITY|||||||0.38||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.38
91734493|NCT00023595|183363364|SUPERIORITY|||||||0.45||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.45
91734494|NCT00023595|183363364|SUPERIORITY|||||||0.62||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.62
91734495|NCT00023595|183363364|SUPERIORITY|||||||0.82||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.82
91734496|NCT00023595|183363364|SUPERIORITY|||||||0.94||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.94
91734497|NCT00023595|183363365|SUPERIORITY|||||||0.205||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.205
91734498|NCT00023595|183363365|SUPERIORITY|||||||0.017||||||12 months|Chi-squared|||||||0.017
91734499|NCT00023595|183363365|SUPERIORITY|||||||0.028||||||24 months|Chi-squared|||||||0.028
91734500|NCT00023595|183363365|SUPERIORITY|||||||0.123||||||36 months|Chi-squared|||||||0.123
91734501|NCT00023595|183363366|SUPERIORITY|||||||0.19||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.19
91734502|NCT00023595|183363366|SUPERIORITY|||||||0.07||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.07
91734503|NCT00023595|183363366|SUPERIORITY|||||||0.94||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.94
91734504|NCT00023595|183363366|SUPERIORITY|||||||0.67||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.67
91734505|NCT00023595|183363366|SUPERIORITY|||||||0.44||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.44
91734506|NCT00023595|183363367|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
91734507|NCT00023595|183363367|SUPERIORITY|||||||0.006||||||12 months|Chi-squared|||||||0.006
91734508|NCT00023595|183363367|SUPERIORITY|||||||0.039||||||24 months|Chi-squared|||||||0.039
91734509|NCT00023595|183363367|SUPERIORITY|||||||0.074||||||36 months|Chi-squared|||||||0.074
91734510|NCT00023595|183363368|SUPERIORITY|||||||0.23||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.23
91734511|NCT00023595|183363368|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
91734512|NCT00023595|183363368|SUPERIORITY|||||||0.35||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.35
91734513|NCT00023595|183363368|SUPERIORITY|||||||0.9||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.90
91734514|NCT00023595|183363368|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
91734515|NCT00023595|183363369|SUPERIORITY|||||||0.085||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.085
91734516|NCT00023595|183363369|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
91734517|NCT00023595|183363369|SUPERIORITY|||||||0.026||||||24 months|Chi-squared|||||||0.026
91734518|NCT00023595|183363369|SUPERIORITY|||||||0.085||||||36 months|Chi-squared|||||||0.085
91734519|NCT00023595|183363370|SUPERIORITY|||||||0.18||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.18
91734520|NCT00023595|183363370|SUPERIORITY|||||||0.17||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.17
91734521|NCT00023595|183363370|SUPERIORITY|||||||0.59||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.59
91734522|NCT00023595|183363370|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
91734523|NCT00023595|183363370|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
91734524|NCT00023595|183363371|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
91734525|NCT00023595|183363371|SUPERIORITY||||||<|0.001||||||12 month|Chi-squared|||||||<0.001
91734526|NCT00023595|183363371|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
91734527|NCT00023595|183363371|SUPERIORITY|||||||0.018||||||36 months|Chi-squared|||||||0.018
91734528|NCT00023595|183363372|SUPERIORITY|||||||0.7||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.70
91734529|NCT00023595|183363372|SUPERIORITY|||||||0.47||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.47
91734530|NCT00023595|183363372|SUPERIORITY|||||||0.87||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.87
91734531|NCT00023595|183363372|SUPERIORITY|||||||0.84||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.84
91734532|NCT00023595|183363372|SUPERIORITY|||||||0.82||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.82
91734533|NCT00023595|183363373|SUPERIORITY|||||||0.023||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.023
91734534|NCT00023595|183363373|SUPERIORITY|||||||0.001||||||12 months|Chi-squared|||||||0.001
91513336|NCT00360334|182898221|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||ANCOVA|||||||0.125
91513337|NCT00360334|182898222|SUPERIORITY_OR_OTHER|||||||0.471||95.0|||||ANCOVA|||||||0.471
91734535|NCT00023595|183363373|SUPERIORITY|||||||0.077||||||24 months|Chi-squared|||||||0.077
91734536|NCT00023595|183363373|SUPERIORITY|||||||0.17||||||36 months|Chi-squared|||||||0.170
91734537|NCT00023595|183363374|SUPERIORITY|||||||0.63||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.63
91734538|NCT00023595|183363374|SUPERIORITY|||||||0.29||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.29
91734539|NCT00023595|183363374|SUPERIORITY|||||||0.68||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.68
91734540|NCT00023595|183363374|SUPERIORITY|||||||0.25||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.25
91734541|NCT00023595|183363374|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
91734542|NCT00023595|183363375|SUPERIORITY|||||||0.033||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.033
91734543|NCT00023595|183363375|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
91734544|NCT00023595|183363375|SUPERIORITY|||||||0.015||||||24 months|Chi-squared|||||||0.015
91734545|NCT00023595|183363375|SUPERIORITY|||||||0.051||||||36 months|Chi-squared|||||||0.051
91734546|NCT00023595|183363376|SUPERIORITY|||||||0.26||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.26
91734547|NCT00023595|183363376|SUPERIORITY|||||||0.23||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.23
91734548|NCT00023595|183363376|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
91734549|NCT00023595|183363376|SUPERIORITY|||||||0.98||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.98
91734550|NCT00023595|183363376|SUPERIORITY|||||||0.86||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.86
91734551|NCT00023595|183363377|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
91734552|NCT00023595|183363377|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91734553|NCT00023595|183363377|SUPERIORITY|||||||0.006||||||24 months|Chi-squared|||||||0.006
91734554|NCT00023595|183363377|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
91734555|NCT00023595|183363378|SUPERIORITY|||||||0.53||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.53
91734556|NCT00023595|183363378|SUPERIORITY|||||||0.26||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.26
91734557|NCT00023595|183363378|SUPERIORITY|||||||0.76||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.76
91734558|NCT00023595|183363378|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
91734559|NCT00023595|183363378|SUPERIORITY|||||||0.89||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.89
91734560|NCT00023595|183363379|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
91734561|NCT00023595|183363379|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
91734562|NCT00023595|183363379|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
91734563|NCT00023595|183363379|SUPERIORITY|||||||0.01||||||36 months|Chi-squared|||||||0.010
91734564|NCT00023595|183363380|SUPERIORITY|||||||0.01||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.01
91734565|NCT00023595|183363380|SUPERIORITY|||||||0.74||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.74
91734566|NCT00023595|183363380|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
91734567|NCT00023595|183363380|SUPERIORITY|||||||0.46||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.46
91734568|NCT00023595|183363380|SUPERIORITY|||||||0.27||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.27
91734569|NCT00023595|183363381|SUPERIORITY|||||||0.029||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.029
91734570|NCT00023595|183363381|SUPERIORITY|||||||0.042||||||12 months|Chi-squared|||||||0.042
91734571|NCT00023595|183363381|SUPERIORITY|||||||0.3||||||24 months|Chi-squared|||||||0.30
91734572|NCT00023595|183363381|SUPERIORITY|||||||0.2||||||36 months|Chi-squared|||||||0.20
91734573|NCT00023595|183363382|SUPERIORITY|||||||0.98||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.98
91734574|NCT00023595|183363382|SUPERIORITY|||||||0.16||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.16
91495326|NCT03462082|182862705|SUPERIORITY|||||||0.44||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.440
91529964|NCT02471404|182936133|SUPERIORITY||Mean Difference (Final Values)|-4.91|||<|0.001|TWO_SIDED|95.0|-5.52|-4.29|||Mixed Models Analysis|||||-4.29|-5.52|<0.001
91495327|NCT03462082|182862705|SUPERIORITY|||||||0.051||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.051
91513338|NCT00360334|182898223|SUPERIORITY_OR_OTHER|||||||0.601||95.0|||||ANCOVA|||||||0.601
91513339|NCT00360334|182898224|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||||||0.650
91529965|NCT02471404|182936134|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.374|TWO_SIDED|95.0|-0.43|0.16|||Mixed Models Analysis|||||0.16|-0.43|0.374
91734575|NCT00023595|183363382|SUPERIORITY|||||||0.88||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.88
91734576|NCT00023595|183363382|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
91734577|NCT00023595|183363382|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
91734578|NCT00023595|183363383|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
91734579|NCT00023595|183363383|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
91734580|NCT00023595|183363383|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
91734581|NCT00023595|183363383|SUPERIORITY|||||||0.001||||||36 months|Chi-squared|||||||0.001
91734582|NCT00023595|183363384|SUPERIORITY|||||||0.86||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.86
91734583|NCT00023595|183363384|SUPERIORITY|||||||0.39||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.39
91734584|NCT00023595|183363384|SUPERIORITY|||||||0.65||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.65
91734585|NCT00023595|183363384|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
91734586|NCT00023595|183363384|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
91734587|NCT00023595|183363385|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
91734588|NCT00023595|183363385|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
91734589|NCT00023595|183363385|SUPERIORITY|||||||0.001||||||24 months|Chi-squared|||||||0.001
91734590|NCT00023595|183363385|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91734591|NCT00023595|183363386|SUPERIORITY|||||||0.96||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.96
91734592|NCT00023595|183363386|SUPERIORITY|||||||0.53||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.53
91734593|NCT00023595|183363386|SUPERIORITY|||||||0.37||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.37
91734594|NCT00023595|183363386|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
91734595|NCT00023595|183363386|SUPERIORITY|||||||0.21||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.21
91734596|NCT00023595|183363387|SUPERIORITY|||||||0.007||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.007
91734597|NCT00023595|183363387|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
91734598|NCT00023595|183363387|SUPERIORITY|||||||0.023||||||24 months|Chi-squared|||||||0.023
91734599|NCT00023595|183363387|SUPERIORITY|||||||0.06||||||36 months|Chi-squared|||||||0.060
91734600|NCT00023595|183363388|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
91734601|NCT00023595|183363388|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
91734602|NCT00023595|183363388|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
91734603|NCT00023595|183363388|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
91734604|NCT00023595|183363388|SUPERIORITY|||||||0.38||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.38
91734605|NCT00023595|183363389|SUPERIORITY|||||||0.86||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.86
91734606|NCT00023595|183363389|SUPERIORITY|||||||0.78||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.78
91734607|NCT00023595|183363389|SUPERIORITY|||||||0.55||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.55
91734608|NCT00023595|183363389|SUPERIORITY|||||||0.027||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.027
91734609|NCT00023595|183363389|SUPERIORITY|||||||0.031||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.031
91734610|NCT00023595|183363390|SUPERIORITY|||||||0.4||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.40
91734611|NCT00023595|183363390|SUPERIORITY|||||||0.42||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.42
91734612|NCT00023595|183363390|SUPERIORITY|||||||0.41||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.41
91734613|NCT00023595|183363390|SUPERIORITY|||||||0.25||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
91734614|NCT00023595|183363390|SUPERIORITY|||||||0.25||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
91734615|NCT00023595|183363391|SUPERIORITY|||||||0.002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.002
91734616|NCT00023595|183363391|SUPERIORITY|||||||0.007||||||12 months|Chi-squared|||||||0.007
91734617|NCT00023595|183363391|SUPERIORITY|||||||0.049||||||24 months|Chi-squared|||||||0.049
91734618|NCT00023595|183363391|SUPERIORITY|||||||0.038||||||36 months|Chi-squared|||||||0.038
91734619|NCT00023595|183363392|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
91734620|NCT00023595|183363392|SUPERIORITY|||||||0.37||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.37
91734621|NCT00023595|183363392|SUPERIORITY|||||||0.98||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.98
91734622|NCT00023595|183363392|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
91734623|NCT00023595|183363392|SUPERIORITY|||||||0.04||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.04
91734624|NCT00023595|183363393|SUPERIORITY|||||||0.036||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.036
91734625|NCT00023595|183363393|SUPERIORITY|||||||0.043||||||12 months|Chi-squared|||||||0.043
91734626|NCT00023595|183363393|SUPERIORITY|||||||0.018||||||24 months|Chi-squared|||||||0.018
91734627|NCT00023595|183363393|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
91734628|NCT00023595|183363394|SUPERIORITY|||||||0.75||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.75
91734629|NCT00023595|183363394|SUPERIORITY|||||||0.72||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.72
91734630|NCT00023595|183363394|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
91734631|NCT00023595|183363394|SUPERIORITY|||||||0.52||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.52
91734632|NCT00023595|183363394|SUPERIORITY|||||||0.12||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.12
91734633|NCT00023595|183363395|SUPERIORITY|||||||0.0002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.0002
91734634|NCT00023595|183363395|SUPERIORITY||||||<|0.0001||||||12 months|Chi-squared|||||||<0.0001
91734635|NCT00023595|183363395|SUPERIORITY|||||||0.009||||||24 months|Chi-squared|||||||0.009
91734636|NCT00023595|183363395|SUPERIORITY|||||||0.32||||||36 months|Chi-squared|||||||0.32
91734637|NCT00023595|183363396|SUPERIORITY|||||||0.6||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.60
91734638|NCT00023595|183363396|SUPERIORITY|||||||0.14||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.14
91734639|NCT00023595|183363396|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
91513340|NCT00360334|182898225|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANCOVA|||||||0.017
91734640|NCT00023595|183363396|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
91734641|NCT00023595|183363396|SUPERIORITY|||||||0.84||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.84
91734642|NCT00023595|183363397|SUPERIORITY||||||<|0.0001||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||<0.0001
91734643|NCT00023595|183363397|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
91734644|NCT00023595|183363397|SUPERIORITY||||||<|0.0001||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||<0.0001
91734645|NCT00023595|183363398|SUPERIORITY|||||||0.006||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||0.006
91734646|NCT00023595|183363398|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
91734647|NCT00023595|183363398|SUPERIORITY|||||||0.004||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||0.004
91734648|NCT02106832|183363404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7062||||0.0511|TWO_SIDED|99.9|0.3928|1.2698|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2698|0.3928|0.0511
91734649|NCT02106832|183363412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8662||||0.3965|TWO_SIDED|95.1|0.6206|1.209|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2090|0.6206|0.3965
91734650|NCT00619866|183363415|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2311|TWO_SIDED|95.0|-0.81|0.2|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.20|-0.81|0.2311
91495328|NCT03462082|182862706|SUPERIORITY|||||||0.945||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.945
91495329|NCT03462082|182862706|SUPERIORITY|||||||0.024||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.024
91495330|NCT03462082|182862707|SUPERIORITY|||||||0.097||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.097
91529966|NCT02471404|182936134|SUPERIORITY||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.88|-0.31|||Mixed Models Analysis|||||-0.31|-0.88|<0.001
91529967|NCT02471404|182936135|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.777|TWO_SIDED|95.0|0.67|1.35|||Regression, Cox|||||1.35|0.67|0.777
91529968|NCT02471404|182936135|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.23|0.57|||Regression, Cox|||||0.57|0.23|<0.001
91529969|NCT02204293|182936137|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.||||||0.1811|||||||Fisher Exact|||||||0.1811
91529970|NCT02204293|182936152|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|19.9||||0.3175|TWO_SIDED|95.0|-15.0|51.3|||Fisher Exact|||||51.3|-15.0|0.3175
91529971|NCT02204293|182936153|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|31.7||||0.0922|TWO_SIDED|95.0|-2.9|61.8|||Fisher Exact|||||61.8|-2.9|0.0922
91529972|NCT02204293|182936154|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.0||||0.0858|TWO_SIDED|95.0|-1.5|61.1|||Fisher Exact|||||61.1|-1.5|0.0858
91529973|NCT02204293|182936155|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.4||||0.075|TWO_SIDED|95.0|-0.7|60.5|||Fisher Exact|||||60.5|-0.7|0.075
91529974|NCT02204293|182936156|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||||43.4|-12.6|0.4018
91529975|NCT02204293|182936157|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|5.2||||1|TWO_SIDED|95.0|-18.8|29.2|||Fisher Exact|||||29.2|-18.8|1
91529976|NCT02204293|182936158|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|24.8||||0.1642|TWO_SIDED|95.0|-8.0|54.2|||Fisher Exact|||EULAR DAS28-ESR Response||54.2|-8.0|0.1642
91529977|NCT02204293|182936158|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|25.2||||0.1756|TWO_SIDED|95.0|-9.1|55.1|||Fisher Exact|||EULAR DAS28-CRP Response||55.1|-9.1|0.1756
91734651|NCT00619866|183363415|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.25||0.1521|TWO_SIDED|95.0|-0.86|0.14|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.14|-0.86|0.1521
91734652|NCT00619866|183363416|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2041|TWO_SIDED|95.0|-0.77|0.17|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.17|-0.77|0.2041
91734653|NCT00619866|183363416|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.24||0.3375|TWO_SIDED|95.0|-0.69|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-0.69|0.3375
91734654|NCT00619866|183363416|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.0354|TWO_SIDED|95.0|-1.01|-0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.04|-1.01|0.0354
91760032|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.01|
91529978|NCT02204293|182936159|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|3.9||||1|TWO_SIDED|95.0|-27.7|35.0|||Fisher Exact|||DAS28 (ESR) LDA||35.0|-27.7|1
91529979|NCT02204293|182936159|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|26.5||||0.1642|TWO_SIDED|95.0|-6.6|56.0|||Fisher Exact|||DAS28 (CRP) LDA||56.0|-6.6|0.1642
91529980|NCT02204293|182936160|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|21.6||||0.2285|TWO_SIDED|95.0|-8.1|49.9|||Fisher Exact|||DAS28 (ESR) remission||49.9|-8.1|0.2285
91495331|NCT03462082|182862707|SUPERIORITY|||||||0.75||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.750
91529981|NCT02204293|182936160|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|27.1||||0.1212|TWO_SIDED|95.0|-4.6|54.6|||Fisher Exact|||DAS28 (CRP) Remission||54.6|-4.6|0.1212
91495332|NCT03462082|182862708|SUPERIORITY|||||||0.128||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.128
91529982|NCT02204293|182936160|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||Extended Remission||43.4|-12.6|0.4018
91529983|NCT04779242|182936170|OTHER|Difference was observed difference in early clinical success rate between the omadacycline and moxifloxacin groups|Percentage difference|1.9|||||TWO_SIDED|95.0|-3.0|6.8|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification.|||6.8|-3.0|
91529984|NCT04779242|182936171|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups.|Percentage difference|-1.7|||||TWO_SIDED|95.0|-6.9|3.4|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||3.4|-6.9|
91529985|NCT04779242|182936172|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups|Percentage difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.0|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||2.0|-5.7|
91529986|NCT01757067|182936173|OTHER|The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||||||||||||||||The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||
91529987|NCT00507026|182936233|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529988|NCT00507026|182936233|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529989|NCT00507026|182936234|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529990|NCT00507026|182936234|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529991|NCT00507026|182936235|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529992|NCT00507026|182936235|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529993|NCT00507026|182936236|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529994|NCT00507026|182936236|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529995|NCT00507026|182936237|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529996|NCT00507026|182936237|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91529997|NCT04230980|182936248|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.01|TWO_SIDED|95.0|-2.02|-0.24|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean NRS-11 score at post-operative day 7 (compared between the two arms).||-0.24|-2.02|0.01
91529998|NCT04230980|182936249|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.19|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean number of opioid tablets taken at post-operative day 7 (compared between the two arms).||0.03|-0.13|0.19
91529999|NCT04285229|182936252|SUPERIORITY||Odds Ratio (OR)|7.64|||<|0.001|TWO_SIDED|95.0|2.68|21.76|||Regression, Logistic|||||21.76|2.68|<0.001
91530000|NCT04285229|182936253|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.42|16.9|||Regression, Logistic|||||16.90|2.42|<0.001
91530001|NCT04285229|182936254|SUPERIORITY||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.31|5.09|||Regression, Logistic|||||5.09|1.31|0.006
91530002|NCT04285229|182936255|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.38|-0.9|||Mixed Models Analysis|||||-0.90|-1.38|<0.001
91530003|NCT04285229|182936256|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.04|-0.94|||Mixed Models Analysis|||||-0.94|-2.04|<0.001
91530004|NCT04285229|182936257|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.28||0.002|TWO_SIDED|95.0|-1.43|-0.32|||Mixed Models Analysis|||||-0.32|-1.43|0.002
91530005|NCT04285229|182936258|SUPERIORITY||LS Mean Difference|-7.72|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-10.85|-4.6|||ANCOVA|||||-4.60|-10.85|<0.001
91530006|NCT04285229|182936259|SUPERIORITY||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.785||0.001|TWO_SIDED|95.0|1.07|4.17|||Mixed Models Analysis|||||4.17|1.07|0.001
91530007|NCT04285229|182936260|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.152||0.66|TWO_SIDED|95.0|-1.77|2.79|||Mixed Models Analysis|||||2.79|-1.77|0.660
91530008|NCT04285229|182936261|SUPERIORITY||LS Mean Difference|-12.75|STANDARD_ERROR_OF_MEAN|1.594|<|0.001|TWO_SIDED|95.0|-15.91|-9.59|||Mixed Models Analysis|||||-9.59|-15.91|<0.001
91530009|NCT04285229|182936262|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.57|-0.15|||Mixed Models Analysis|||||-0.15|-0.57|<0.001
91530010|NCT04285229|182936263|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.413||0.086|TWO_SIDED|95.0|-1.54|0.1|||Mixed Models Analysis|||||0.10|-1.54|0.086
91530011|NCT04285229|182936264|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.034|<|0.001|TWO_SIDED|95.0|-7.71|-3.62|||ANCOVA|||||-3.62|-7.71|<0.001
91530012|NCT00322868|182936297|SUPERIORITY_OR_OTHER|||||||0.2772|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum white cell count||||||0.2772
91734655|NCT00619866|183363416|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3618|TWO_SIDED|95.0|-0.71|0.26|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.26|-0.71|0.3618
91495333|NCT03462082|182862708|SUPERIORITY|||||||0.117||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.117
91495334|NCT03462082|182862708|SUPERIORITY|||||||0.145||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.145
91513341|NCT00360334|182898226|SUPERIORITY_OR_OTHER|||||||0.667||95.0|||||ANCOVA|||||||0.667
91513342|NCT00360334|182898227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.675||||0.139||95.0|0.401|1.136|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.136|0.401|0.139
91530013|NCT00322868|182936298|SUPERIORITY_OR_OTHER|||||||0.2467|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count||||||0.2467
91530014|NCT00322868|182936299|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in sputum percent neutrophils||||||0.0288
91530015|NCT00322868|182936300|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum active elastase||||||0.50
91513343|NCT00360334|182898228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.317||||0.001||95.0|0.159|0.63|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||0.630|0.159|0.001
91513344|NCT00360334|182898229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.716||95.0|0.235|2.705|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||2.705|0.235|0.716
91513345|NCT00360334|182898230|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANCOVA on ranks|||||||0.113
91513346|NCT00360334|182898231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA on ranks|||||||<0.001
91513347|NCT00360334|182898232|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANCOVA on ranks|||||||0.740
91513348|NCT03809182|182898266|SUPERIORITY|||||||0.38|TWO_SIDED|95.0||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.38
91513349|NCT03809182|182898267|SUPERIORITY|||||||0.02||||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.02
91513350|NCT01763567|182898273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|STANDARD_DEVIATION|9.5|||TWO_SIDED|||||||||||||
91513351|NCT01763567|182898274|SUPERIORITY_OR_OTHER||percent of events correctly detected|16.7|||||TWO_SIDED|||||||||||||
91513352|NCT01763567|182898275|SUPERIORITY_OR_OTHER||percent of events correctly detected|88.9|||||TWO_SIDED|||||||||||||
91513353|NCT01763567|182898276|SUPERIORITY_OR_OTHER||% of false alert|85.8|||||TWO_SIDED|||||||||||||
91513354|NCT01763567|182898277|SUPERIORITY_OR_OTHER||% of false alert|56.5|||||TWO_SIDED|||||||||||||
91513355|NCT03017508|182898305|SUPERIORITY||Mean Difference (Final Values)|-8.34|STANDARD_DEVIATION|18.34||0.056|TWO_SIDED||||||t-test, 2 sided|||Paired t-test on VAS scores during speech comparing sublingual riluzole to placebo||||0.056
91513356|NCT02162810|182898306|OTHER||||||<|0.62|||||||Fisher Exact|||Due to the number of 0 cell counts, it is not possible to do individual statistics for each complication, so we looked at the incidence of complications overall between the two arms.||||<.62
91513357|NCT02162810|182898307|OTHER||||||<|0.61|||||||Fisher Exact|||||||<0.61
91513358|NCT02162810|182898308|OTHER||||||<|0.87|||||||Fisher Exact|||Improvement category: Chordee with Degloving||||<.87
91513359|NCT02162810|182898308|OTHER||||||<|0.64|||||||Fisher Exact|||Improvement category: Ventral Chordee||||<.64
91513360|NCT02162810|182898308|OTHER||||||<|0.85|||||||Fisher Exact|||Improvement category: Chordee with Plication||||<.85
91513361|NCT00389324|182898314|NON_INFERIORITY_OR_EQUIVALENCE|The administration effect between SC and IV was assessed by exponentiation of the difference in least squares means between study phases (Test minus Reference) and the corresponding 90% confidence interval (CI) for the geometric LSM ratio between study phases (Test/Reference) for AUC. The Test (SC) was to be considered non-inferior to Reference (IV) if the lower bound of 90% CIs for the geometric LSM ratios of AUC between the Test and Reference was above 0.80 (80%).|Geometric Least Square Mean Ratio|0.888||||||90.0|0.861|0.917|||ANOVA||An adjusted steady-state area under the concentration vs. time curve following SC administration based on IV dosing schedule was calculated as AUC0-τ,SC multiplied by 3 or 4 for subjects on every-3-week or every-4-week IV dosing schedule.|The IV phase was considered as the Reference study phase and the SC phase as the Test study phase. The ANOVA included calculation of least-squares means (LSM), differences between adjusted means and the standard error associated with these differences.||0.917|0.861|
91495335|NCT03462082|182862708|SUPERIORITY|||||||0.056||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.056
91495336|NCT03462082|182862708|SUPERIORITY|||||||0.151||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.151
91495337|NCT03462082|182862708|SUPERIORITY|||||||0.129||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.129
91530016|NCT00322868|182936301|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum TNFα||||||0.62
91530017|NCT00322868|182936302|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß||||||0.50
91734656|NCT00619866|183363417|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.46||0.799|TWO_SIDED|95.0|-1.01|0.78|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.78|-1.01|0.7990
91734657|NCT00619866|183363417|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.46||0.5042|TWO_SIDED|95.0|-1.21|0.59|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.59|-1.21|0.5042
91734658|NCT00619866|183363417|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.48||0.1459|TWO_SIDED|95.0|-1.63|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-1.63|0.1459
91734659|NCT00619866|183363417|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.48||0.0163|TWO_SIDED|95.0|-2.1|-0.21|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.21|-2.10|0.0163
91734660|NCT00619866|183363417|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0207|TWO_SIDED|95.0|-2.13|-0.18|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.18|-2.13|0.0207
91734661|NCT00619866|183363417|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.5||0.0038|TWO_SIDED|95.0|-2.42|-0.47|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.47|-2.42|0.0038
91734662|NCT00619866|183363418|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5744|TWO_SIDED|95.0|-0.18|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.18|0.5744
91734663|NCT00619866|183363418|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.728|TWO_SIDED|95.0|-0.17|0.12|||Repeated measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.17|0.7280
91530018|NCT00322868|182936303|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-6||||||0.55
91530019|NCT00322868|182936304|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-8||||||0.75
91734664|NCT00619866|183363418|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0195|TWO_SIDED|95.0|-0.32|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.32|0.0195
91734665|NCT00619866|183363418|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5589|TWO_SIDED|95.0|-0.19|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.19|0.5589
91734666|NCT00619866|183363418|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5558|TWO_SIDED|95.0|-0.2|0.11|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.11|-0.20|0.5558
91734667|NCT00619866|183363418|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.7121|TWO_SIDED|95.0|-0.18|0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.18|0.7121
91734668|NCT00619866|183363419|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.0286|TWO_SIDED|95.0|-0.54|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.54|0.0286
91734669|NCT00619866|183363419|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.121|TWO_SIDED|95.0|-0.45|0.05|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.05|-0.45|0.1210
91734670|NCT00619866|183363419|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.68|-0.15|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.15|-0.68|0.0024
91734671|NCT00619866|183363419|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.76|-0.22|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.22|-0.76|0.0003
91734672|NCT00619866|183363419|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0021|TWO_SIDED|95.0|-0.72|-0.16|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.16|-0.72|0.0021
91734673|NCT00619866|183363419|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.24|-0.80|0.0003
91734674|NCT00619866|183363420|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0603|TWO_SIDED|95.0|-0.34|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.34|0.0603
91495338|NCT03462082|182862708|SUPERIORITY|||||||0.698||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.698
91495339|NCT03462082|182862708|SUPERIORITY|||||||0.779||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.779
91495340|NCT03462082|182862709|SUPERIORITY|||||||0.874||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.874
91495341|NCT03462082|182862709|SUPERIORITY|||||||0.976||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.976
91495342|NCT03462082|182862709|SUPERIORITY|||||||0.859||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.859
91734675|NCT00619866|183363420|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1855|TWO_SIDED|95.0|-0.29|0.06|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.06|-0.29|0.1855
91734676|NCT00619866|183363420|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0012|TWO_SIDED|95.0|-0.48|-0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.12|-0.48|0.0012
91734677|NCT00619866|183363420|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1002|TWO_SIDED|95.0|-0.33|0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.03|-0.33|0.1002
91734678|NCT00619866|183363420|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0568|TWO_SIDED|95.0|-0.36|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.36|0.0568
91734679|NCT00619866|183363420|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.119|TWO_SIDED|95.0|-0.33|0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.04|-0.33|0.1190
91734680|NCT03510273|183363476|OTHER|"Type of statistical test: Independence~Description: Adequacy of baseline image"||||||0.396|||||||Fisher Exact|||||||0.396
91734681|NCT03510273|183363476|OTHER|"Type of statistical test: Independence~Description: Squamous columnar junction visibility"||||||0.351|||||||Fisher Exact|||||||0.351
91734682|NCT03510273|183363476|OTHER|"Type of statistical test: Independence~Description: Visible abnormal areas"||||||0.774|||||||Fisher Exact|||||||0.774
91734683|NCT03510273|183363476|OTHER|"Type of statistical test: Independence~Description: Location of the lesion"||||||1|||||||Fisher Exact|||||||1
91495343|NCT03462082|182862709|SUPERIORITY|||||||0.86||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.860
91734684|NCT03510273|183363476|OTHER|"Type of statistical test: Independence~Description: Mosaic of the worst lesion"||||||0.36|||||||Fisher Exact|||||||0.36
91734685|NCT03510273|183363476|OTHER|"Type of Statistical Test: Independence~Description: Acetowhite changes"||||||0.881|||||||Fisher Exact|||||||0.881
91734686|NCT03510273|183363476|OTHER|"Type of Statistical Test: Independence~Description: Border of the worst lesion"||||||0.829|||||||Fisher Exact|||||||0.829
91734687|NCT03510273|183363476|OTHER|"Type of Statistical Test: Independence~Description: Possible diagnosis"||||||1|||||||Fisher Exact|||||||1
91734688|NCT03510273|183363476|OTHER|"Type of Statistical Test: Independence~Description: Baseline histology"||||||1|||||||Fisher Exact|||||||1
91734689|NCT03510273|183363476|OTHER|"Type of Statistical Test: Independence~Description: Size of the worst lesion (% coverage)"||||||0.493|||||||Fisher Exact|||||||0.493
91734690|NCT01474109|183363477|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.103||||0.706|TWO_SIDED|95.0|0.663|1.834|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 3 mg and in Placebo|||1.834|0.663|0.706
91734691|NCT01474109|183363477|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.268||||0.36|TWO_SIDED|95.0|0.763|2.106|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 10 mg and in Placebo|||2.106|0.763|0.360
91734692|NCT01474109|183363478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.875||||0.667|TWO_SIDED|95.0|0.477|1.606|||Chi-squared|||||1.606|0.477|0.6670
91734693|NCT01474109|183363478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.5518|TWO_SIDED|95.0|0.454|1.524|||Chi-squared|||||1.524|0.454|0.5518
91734694|NCT01474109|183363479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.696||||0.3625|TWO_SIDED|95.0|0.319|1.518|||Chi-squared|||||1.518|0.319|0.3625
91495344|NCT03462082|182862710|SUPERIORITY|||||||0.04||||||"Holm-adjusted P-Value: 0.480~\*Pitch (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.040
91495345|NCT03462082|182862710|SUPERIORITY|||||||0.883||||||"Holm-adjusted P-Value: 1.00~\*Pitch (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.883
91495346|NCT03462082|182862710|SUPERIORITY|||||||0.071||||||"Holm-adjusted P-Value: 0.781~\*Pitch (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.071
91495347|NCT03462082|182862710|SUPERIORITY|||||||0.327||||||"Holm-adjusted P-Value: 1.00~\*Pitch (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.327
91495348|NCT03462082|182862711|SUPERIORITY|||||||0.487||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.487
91495349|NCT03462082|182862711|SUPERIORITY|||||||0.861||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.861
91530020|NCT01852162|182936305|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An analysis of covariance (ANCOVA) method with a general linear model, using the corresponding baseline PD value as a covariate, was used to evaluate the comparisons between dabigatran and placebo at 7 days.|ANCOVA|||Assuming a 20% relative difference in TRAP induced MPA between dabigatran and placebo with a common standard deviation of 10%, 13 patients with available data needed to be randomized to obtain a 95% power and 2-sided alpha=0.05.||||<0.05
91702397|NCT00772005|183299678|SUPERIORITY_OR_OTHER|||||||0.189||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1890
91734695|NCT01474109|183363479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9362|TWO_SIDED|95.0|0.498|2.133|||Chi-squared|||||2.133|0.498|0.9362
91734696|NCT01474109|183363480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.863|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.863
91702398|NCT00772005|183299679|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6320
91702399|NCT00772005|183299679|SUPERIORITY_OR_OTHER|||||||0.8777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8777
91702400|NCT00772005|183299679|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4378
91702401|NCT00772005|183299680|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5544
91702402|NCT00772005|183299680|SUPERIORITY_OR_OTHER|||||||0.4446||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4446
91702403|NCT00772005|183299680|SUPERIORITY_OR_OTHER|||||||0.4483||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4483
91702404|NCT00772005|183299681|SUPERIORITY_OR_OTHER|||||||0.1914||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1914
91702405|NCT00772005|183299681|SUPERIORITY_OR_OTHER|||||||0.2543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2543
91702406|NCT00772005|183299681|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
91702407|NCT00772005|183299682|SUPERIORITY_OR_OTHER|||||||0.5312||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5312
91495350|NCT03462082|182862711|SUPERIORITY|||||||0.411||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.411
91495351|NCT03462082|182862711|SUPERIORITY|||||||0.997||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.997
91495352|NCT03462082|182862712|SUPERIORITY|||||||0.388||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.388
91495353|NCT03462082|182862712|SUPERIORITY|||||||0.684||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.684
91530021|NCT01500226|182936320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.2|<0.001
91530022|NCT01500226|182936321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.143|TWO_SIDED|95.0|0.9|1.6||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.6|0.9|0.143
91530023|NCT01500226|182936322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.3|<0.001
91530024|NCT04212169|182936347|SUPERIORITY||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|8.981||0.888|TWO_SIDED|90.0|-13.67|16.22|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||16.22|-13.67|0.888
91530025|NCT04212169|182936347|SUPERIORITY||Mean Difference (Final Values)|5.87|STANDARD_ERROR_OF_MEAN|9.756||0.549|TWO_SIDED|90.0|-10.36|22.1|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||22.10|-10.36|0.549
91530026|NCT04212169|182936347|SUPERIORITY||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|7.014||0.807|TWO_SIDED|90.0|-13.38|9.95|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||9.95|-13.38|0.807
91530027|NCT04212169|182936349|SUPERIORITY||Odds Ratio (OR)|1.53||||0.6396|TWO_SIDED|90.0|0.19|9.94|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||9.94|0.19|0.6396
91530028|NCT04212169|182936349|SUPERIORITY||Odds Ratio (OR)|0.76||||0.9999|TWO_SIDED|90.0|0.03|6.38|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||6.38|0.03|0.9999
91530029|NCT04212169|182936349|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0935|TWO_SIDED|90.0|0.91|10.49|||Regression, Logistic||Odds ratio greater than 1 favours MEDI3506|||10.49|0.91|0.0935
91530030|NCT04212169|182936351|SUPERIORITY||Odds Ratio (OR)|3.06||||0.445|TWO_SIDED|90.0|0.08|119.65|||Fisher Exact||Odds ratio greater than one favour MEDI3506|||119.65|0.08|0.4450
91530031|NCT04212169|182936351|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9999|TWO_SIDED|90.0|0.0|28.0|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||28.0|0.0|0.9999
91530032|NCT04212169|182936351|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1132|TWO_SIDED|90.0|0.75|130.35|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||130.35|0.75|0.1132
91530033|NCT01646320|182936428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.0964|<|0.0001|TWO_SIDED|95.0|-0.91|-0.53||Tested at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.53|-0.91|<0.0001
91495354|NCT03462082|182862713|SUPERIORITY|||||||0.85||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.850
91530034|NCT01646320|182936429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|4.015|<|0.0001|TWO_SIDED|95.0|-35.4|-19.6||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-19.6|-35.4|<0.0001
91530035|NCT01646320|182936430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|5.493|<|0.0001|TWO_SIDED|95.0|-46.3|-24.7||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-24.7|-46.3|<0.0001
91530036|NCT01646320|182936431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3126|<|0.0001|TWO_SIDED|95.0|-2.12|-0.89||Secondary endpoints are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.89|-2.12|<0.0001
91530037|NCT01646320|182936432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|||<|0.0001|TWO_SIDED|95.0|16.7|34.4||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||34.4|16.7|<0.0001
91530038|NCT02254421|182936433|SUPERIORITY||Treatment difference|-0.02||||0.94|TWO_SIDED|95.0|-0.62|0.57||P-value was calculated from the ANCOVA model including baseline values and stratification factors.|ANCOVA|||||0.57|-0.62|0.94
91530039|NCT02254421|182936434|SUPERIORITY|||||||0.84||||||P-value was calculated from the negative binomial model with stratification factors as covariates.|Negative binomial|||||||0.84
91495355|NCT03462082|182862713|SUPERIORITY|||||||0.712||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.712
91495356|NCT03462082|182862714|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.501
91495357|NCT03462082|182862714|SUPERIORITY|||||||0.216||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.216
91495358|NCT03462082|182862715|SUPERIORITY||||||>|0.05||||||Non-adjusted P-Values were \>0.05 and Holm-adjusted P-Values were 1.00 for all comparisons, except for the Hopkins Verbal Learning Test-Revised: Delayed Recall. For this test, the non-adjusted P-Value was 0.04 and the Holm-adjusted P-Value was 0.44.|Friedman test|Using ranks for repeated measures (3 conditions)||||||>0.05
91530040|NCT02254421|182936435|SUPERIORITY|||||||0.98||||||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.98
91530041|NCT02254421|182936436|SUPERIORITY|||||||0.19||||||P-value was calculated from the CMH test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.19
91530042|NCT01154036|182936453|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-12.7|||<|0.001|TWO_SIDED|95.0|-16.6|-8.7||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-8.7|-16.6|<0.001
91495359|NCT00919724|182862716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.6||0.1||||||Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.|Regression, Linear|||||||0.10
91495360|NCT00166114|182862717|SUPERIORITY_OR_OTHER|||||||0.918|||||||Chi-squared|||Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.||||.918
91495361|NCT03266107|182862743|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91495362|NCT03266107|182862744|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91530043|NCT01154036|182936453|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimate|-9.1|||<|0.001|TWO_SIDED|95.0|-12.9|-5.4||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.4|-12.9|<0.001
91530044|NCT01154036|182936454|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.5|||<|0.001|TWO_SIDED|95.0|-15.9|-5.1||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.1|-15.9|<0.001
91530045|NCT01154036|182936454|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.5|||<|0.001|TWO_SIDED|95.0|-13.6|-5.5||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.5|-13.6|<0.001
91530046|NCT01154036|182936455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.62|3.89|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.89|1.62|<0.001
91530047|NCT01154036|182936455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.007|TWO_SIDED|95.0|1.17|2.67|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||2.67|1.17|0.007
91530048|NCT01154036|182936456|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.55|4.73|||Logistic regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||4.73|1.55|<0.001
91530049|NCT01154036|182936456|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.38|||<|0.001|TWO_SIDED|95.0|1.56|3.63|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.63|1.56|<0.001
91530050|NCT01154036|182936457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.46|||<|0.001|TWO_SIDED|95.0|4.56|19.62|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||19.62|4.56|<0.001
91530051|NCT01154036|182936457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.23|6.82|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||6.82|2.23|<0.001
91495363|NCT03266107|182862747|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91530052|NCT01154036|182936458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|27.77||||0.001|TWO_SIDED|95.0|3.64|211.83|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||211.83|3.64|0.001
91530053|NCT01154036|182936458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.08|||<|0.001|TWO_SIDED|95.0|2.85|17.56|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||17.56|2.85|<0.001
91734697|NCT01474109|183363480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.649|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.649
91495364|NCT02548650|182862760|NON_INFERIORITY|Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.|Mean Difference (Net)|12.0|||>|0.05|TWO_SIDED|95.0|3.0|21.0|||ANOVA|||The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment||21|3|>0.05
91495365|NCT01191801|182862762|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.0305|ONE_SIDED|95.0||||Unstratified one sided P-Value|Unstratified Log Rank|Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).||||||0.0305
91495366|NCT01191801|182862763|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
91734698|NCT01474109|183363481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.456|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.456
91734699|NCT01474109|183363481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.44|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.440
91734700|NCT01474109|183363482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.464|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.464
91734701|NCT01474109|183363482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.342|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.342
91734702|NCT02589938|183363483|SUPERIORITY|Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks||||||0.0167|||||||ANCOVA|||The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.||||0.0167
91734703|NCT04716894|183363486|OTHER||adjusted geometric mean (gMean) ratio(%)|197.77|||||TWO_SIDED|90.0|187.9|208.15|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 7.0.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||208.15|187.90|
91734704|NCT04716894|183363487|OTHER||adjusted geometric mean (gMean) ratio(%)|143.38|||||TWO_SIDED|90.0|121.92|168.6|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 22.1.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||168.60|121.92|
91734705|NCT04716894|183363488|OTHER||adjusted geometric mean (gMean) ratio(%)|201.64|||||TWO_SIDED|90.0|192.23|211.52|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 6.5.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||211.52|192.23|
91734706|NCT00608062|183363490|OTHER|Repeated measurements of FMD were modeled using a general linear mixed model with maximum likelihood estimation. An unstructured covariance structure allowing for heterogeneity in the parameter estimate for each level of menopause stage was chosen for the model based on using AIC to compare various covariance structures.||||||0.05|||||||Mixed Models Analysis|||||||0.05
91734707|NCT00608062|183363492|OTHER|Similar analyses as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
91495367|NCT01191801|182862766|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
91495368|NCT01191801|182862767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|ONE_SIDED|95.0||||Unstratified one-sided P-Value|Log Rank|||||||<0.0001
91734708|NCT00608062|183363493|OTHER|same analysis as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
91734709|NCT01467466|183363506|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7|TWO_SIDED|95.0|0.73|1.24|||Wald's Chi-Square|||||1.24|0.73|0.70
91734710|NCT01467466|183363507|SUPERIORITY||Odds Ratio (OR)|1.02||||0.86|TWO_SIDED|95.0|0.78|1.34|||Wald's Chi-Square|||||1.34|0.78|0.86
91734711|NCT00330733|183363524|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student's t tests or Wilcoxon signed rank tests.||||<0.05
91734712|NCT01979185|183363567|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.632|||||TWO_SIDED|90.0|0.538|0.744|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.744|0.538|
91759503|NCT02391363|183411754|SUPERIORITY|||||||0.08||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.08
91495369|NCT01191801|182862768|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3134|TWO_SIDED|95.0||||One sided P-Value|Log Rank|||||||0.3134
91495370|NCT00320411|182862797|SUPERIORITY_OR_OTHER||percentage of participants|17.2||||||95.0|8.6|29.4||||||||29.4|8.6|
91495371|NCT00320411|182862799|SUPERIORITY_OR_OTHER||percentage of participants|32.3||||||95.0|20.0|44.7||||||||44.7|20.0|
91495372|NCT00320411|182862800|SUPERIORITY_OR_OTHER||percentage of participants|22.8||||||95.0|11.6|34.0||||||||34.0|11.6|
91530054|NCT01154036|182936459|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.1|||<|0.001|TWO_SIDED|95.0|-9.7|-4.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.4|-9.7|<0.001
91530055|NCT01154036|182936459|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8|||<|0.001|TWO_SIDED|95.0|-8.3|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-8.3|<0.001
91530056|NCT01154036|182936460|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.8|||<|0.001|TWO_SIDED|95.0|-10.7|-3.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.0|-10.7|<0.001
91495373|NCT01537393|182862845|NON_INFERIORITY|The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.|Risk Difference (RD)|3.2|||||ONE_SIDED|95.0||5.4|||||||The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.|5.4||
91495374|NCT01537393|182862845|OTHER|Confounding and treatment interactions were assessed in Cox proportional hazards regression models|Hazard Ratio (HR)|1.71||||0.02|TWO_SIDED|95.0|1.09|2.71|||Regression, Cox|Unadjusted Hazard Ratio||||2.71|1.09|0.02
91530057|NCT01154036|182936460|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.4|||<|0.001|TWO_SIDED|95.0|-10.2|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-10.2|<0.001
91530058|NCT01154036|182936461|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-2.1||||0.466|TWO_SIDED|95.0|-7.8|3.5|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||3.5|-7.8|0.466
91734713|NCT01979185|183363568|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.63|||||TWO_SIDED|90.0|0.543|0.73|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.730|0.543|
91495375|NCT01537393|182862846|OTHER|The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.|Mean Difference (Final Values)|73.0||||0.03|TWO_SIDED|95.0|8.0|138.0|||Mixed Models Analysis|Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor||||138|8|0.03
91530059|NCT01154036|182936461|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-4.9||||0.081|TWO_SIDED|95.0|-10.3|0.5|||Constrained Longitudinal Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||0.5|-10.3|0.081
91760033|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.24|-0.10|
91530060|NCT01154036|182936462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-2.8||||0.466|TWO_SIDED|95.0|-10.2|4.7|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.7|-10.2|0.466
91530061|NCT01154036|182936462|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squarres Means|-7.1||||0.011|TWO_SIDED|95.0|-12.6|-1.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||-1.6|-12.6|0.011
91530062|NCT01154036|182936463|SUPERIORITY_OR_OTHER_LEGACY||Difference in M--estimates|1.7||||0.133|TWO_SIDED|95.0|-0.5|4.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||4.0|-0.5|0.133
91760034|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.1|0.25||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.10|
91760035|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.18||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.17|
91760036|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.51|0.13|
91760037|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.11|0.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.11|
91760038|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.04|0.34||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.04|
91495376|NCT00036270|182862851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.118|TWO_SIDED|95.0|0.77|1.03|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.~To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis."||1.03|0.77|0.118
91495377|NCT00036270|182862852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.604|TWO_SIDED|95.0|0.88|1.08|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.~To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used."||1.08|0.88|0.604
91495378|NCT00036270|182862853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.951|TWO_SIDED|95.0|0.89|1.14|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.14|0.89|0.951
91734714|NCT01979185|183363569|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.594|||||TWO_SIDED|90.0|0.526|0.672|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.672|0.526|
91734715|NCT03620981|183363589|SUPERIORITY||LS Mean Difference (Final Values)|-7.2|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.3|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-4.3|-10.0|< 0.0001
91734716|NCT03620981|183363589|SUPERIORITY||LS Mean Difference (Final Values)|-3.7||||0.0175|TWO_SIDED|95.0|-6.8|-0.7|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.7|-6.8|0.0175
91734717|NCT03620981|183363590|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.5|-1.0|< 0.0001
91734718|NCT03620981|183363590|SUPERIORITY||LS Mean Difference (Final Values)|-0.3||||0.0083|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.6|0.0083
91734719|NCT03620981|183363591|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH), Last observation carried forward (LOCF)||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.6|-1.2|< 0.0001
91734720|NCT03620981|183363591|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0052|TWO_SIDED|95.0|-0.8|-0.1|||Cochran-Mantel-Haenszel|CMH, LOCF||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.8|0.0052
91734721|NCT05852470|183363604|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Difference in Means|0.034|STANDARD_ERROR_OF_MEAN|0.0167|||TWO_SIDED|95.0|0.001|0.067||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||0.067|0.001|
91734722|NCT05852470|183363605|SUPERIORITY||Difference in Means|-0.091|STANDARD_ERROR_OF_MEAN|0.0151|<|0.001|TWO_SIDED|95.0|-0.12|-0.061|||t-test, 1 sided||||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|-0.061|-0.120|<.001
91734723|NCT05852470|183363606|SUPERIORITY||Difference in Means|-0.129|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|-0.169|-0.089|||t-test, 1 sided||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||-0.089|-0.169|<.001
91734724|NCT05852470|183363607|SUPERIORITY||Difference in Percentages|17.32|||||TWO_SIDED|90.0|8.66||Upper limit is not applicable for testing.|The lower boundary of the confidence interval is reported instead of a p-value.|Miettinen-Nurminen||Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL||||8.66|
91734725|NCT04116489|183363624|SUPERIORITY|||||||0.5272|||||||Regression, Linear|||||||.5272
91734726|NCT04116489|183363625|SUPERIORITY|||||||0.1657|||||||Regression, Linear|||||||.1657
91734727|NCT04116489|183363626|SUPERIORITY|||||||0.2437|||||||Regression, Linear|||||||.2437
91734728|NCT04116489|183363627|OTHER|||||||0.0373|||||||Regression, Linear|||||||.0373
91734729|NCT03781570|183363629|SUPERIORITY||Mean Difference (Final Values)|-0.0544|STANDARD_ERROR_OF_MEAN|0.00517|<|0.001|TWO_SIDED|95.0|-0.0648|-0.0441|||Mixed Models Analysis|Satterthwaite's method was used to estimate degrees of freedom for the mixed effects model.||Comparing placebo vs. control for thermal pain ratings with mixed effects models controlling for the stimulus intensity and the familial structure of the data.||-0.0441|-0.0648|<0.001
91734730|NCT06028464|183363640|OTHER||Adjusted geometric mean ratio (%)|36.48|||||TWO_SIDED|90.0|31.96|41.64|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 21.9|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||41.64|31.96|
91734731|NCT06028464|183363641|OTHER||Adjusted geometric mean ratio (%)|56.44|||||TWO_SIDED|90.0|45.11|70.6|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 37.9.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||70.60|45.11|
91495379|NCT00036270|182862855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.293|TWO_SIDED|95.0|0.83|1.06|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.06|0.83|0.293
91495380|NCT01218243|182862861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.51|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|2.67|6.36|||ANCOVA|||||6.36|2.67|< 0.01
91495381|NCT01218243|182862862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|6.6|>|0.05|TWO_SIDED|95.0|-9.76|16.44|||Wilcoxon (Mann-Whitney)|||||16.44|-9.76|>0.05
91495382|NCT01218243|182862863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.184|STANDARD_ERROR_OF_MEAN|0.8|>|0.05|TWO_SIDED|95.0|-1.41|1.78|||ANCOVA|||||1.78|-1.41|> 0.05
91495383|NCT01218243|182862864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|1.36|5.05|||ANCOVA|||||5.05|1.36|< 0.01
91495384|NCT01218243|182862865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.12|STANDARD_ERROR_OF_MEAN|1.03|<|0.01|TWO_SIDED|95.0|2.07|6.18|||ANCOVA|||||6.18|2.07|<0.01
91530063|NCT01154036|182936463|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.6||||0.61|TWO_SIDED|95.0|-2.7|1.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.6|-2.7|0.610
91495385|NCT01197560|182862866|SUPERIORITY|||||||0.079|||||||Fisher Exact|||Pertains to all participants; row 1||||0.079
91530064|NCT01154036|182936464|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.52|TWO_SIDED|95.0|-4.2|2.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||2.1|-4.2|0.520
91530065|NCT01154036|182936464|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.7||||0.567|TWO_SIDED|95.0|-3.1|1.7|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.7|-3.1|0.567
91530066|NCT01154036|182936465|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.3||||0.003|TWO_SIDED|95.0|-8.8|-1.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.8|-8.8|0.003
91530067|NCT01154036|182936465|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.011|TWO_SIDED|95.0|-7.7|-1.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.0|-7.7|0.011
91530068|NCT01154036|182936466|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.079|TWO_SIDED|95.0|-9.2|0.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.5|-9.2|0.079
91530069|NCT01154036|182936466|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.7|||<|0.001|TWO_SIDED|95.0|-11.4|-4.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.1|-11.4|<0.001
91530070|NCT01154036|182936467|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|1.6||||0.156|TWO_SIDED|95.0|-0.6|3.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.8|-0.6|0.156
91530071|NCT01154036|182936467|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.9||||0.425|TWO_SIDED|95.0|-2.9|1.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.2|-2.9|0.425
91495386|NCT01197560|182862866|SUPERIORITY|||||||0.279|||||||Fisher Exact|||Pertains to GCB Subtype; row 2||||0.279
91495387|NCT01197560|182862866|SUPERIORITY|||||||0.179|||||||Fisher Exact|||Pertains to non-GCB Sub-type; row 3||||0.179
91495388|NCT01197560|182862867|SUPERIORITY|||||||0.091|||||||Fisher Exact|||Pertains to all participants||||0.091
91495389|NCT01197560|182862868|SUPERIORITY|||||||0.109|||||||Fisher Exact|||||||0.109
91495390|NCT01197560|182862869|SUPERIORITY|||||||0.16|||||||Fisher Exact|||Pertains to all participants; row 1||||0.160
91495391|NCT01197560|182862870|SUPERIORITY|||||||0.529|||||||Log Rank|||||||0.529
91495392|NCT01197560|182862871|SUPERIORITY|||||||0.972|||||||Log Rank|||||||0.972
91495393|NCT01197560|182862872|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.020
91495394|NCT01197560|182862873|SUPERIORITY|||||||0.211|||||||Log Rank|||||||0.211
91495395|NCT02207244|182862905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
91495396|NCT02207244|182862906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
91495397|NCT02207244|182862907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
91495398|NCT02207244|182862908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
91495399|NCT02207244|182862909|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
91495400|NCT02207244|182862910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|||p value is based on the log-rank test stratified by investigator site (pooled).||||< 0.001
91495401|NCT02207244|182862911|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
91495402|NCT02207244|182862912|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|16.4|||<|0.001|TWO_SIDED|95.0|10.0|23.2|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||23.2|10.0|< 0.001
91495403|NCT02207244|182862912|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91495404|NCT02207244|182862913|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|23.3|||<|0.001|TWO_SIDED|95.0|16.0|30.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||30.4|16.0|< 0.001
91495405|NCT02207244|182862913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91495406|NCT02207244|182862914|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10%|Difference in percentage|17.7|||<|0.001|TWO_SIDED|95.0|11.4|24.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||24.4|11.4|< 0.001
91495407|NCT02207244|182862914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91530072|NCT01154036|182936468|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|0.5||||0.739|TWO_SIDED|95.0|-2.5|3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.6|-2.5|0.739
91495408|NCT02207244|182862915|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91495409|NCT02207244|182862916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
91495410|NCT02207244|182862917|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
91530073|NCT01154036|182936468|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.3|-3.3|0.410
91495411|NCT03791489|182862927|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91495412|NCT03791489|182862928|SUPERIORITY||||||<|0.03||||||Threshold for statistical significance = p\<0.05.|t-test, 2 sided|||||||<0.03
91495413|NCT01414010|182863005|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Statistical analysis was performed using a variety of computer packages including XLstat, NCSS 2007, R and NCSS 2010"||||<0.05
91495414|NCT00357968|182863006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.21|||<|0.0001|TWO_SIDED|95.0|38.04|48.38|||ANCOVA|||||48.38|38.04|<0.0001
91530074|NCT01154036|182936469|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.1|||<|0.001|TWO_SIDED|95.0|-13.6|-6.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.6|-13.6|<0.001
91530075|NCT01154036|182936469|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.6|||<|0.001|TWO_SIDED|95.0|-10.9|-4.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.3|-10.9|<0.001
91530076|NCT01154036|182936470|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.0|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-14.0|<0.001
91530077|NCT01154036|182936470|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.8||||0.001|TWO_SIDED|95.0|-13.5|-6.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.2|-13.5|0.001
91530078|NCT01154036|182936471|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.1|||<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-11.2|<0.001
91495415|NCT00357968|182863007|SUPERIORITY_OR_OTHER||LS Mean difference|14.93|||<|0.0001|TWO_SIDED|95.0|10.6|19.26|||Mixed Models Analysis|||||19.26|10.6|<0.0001
91495416|NCT00357968|182863008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.75|||<|0.0001|TWO_SIDED|95.0|38.35|51.15|||ANCOVA|||||51.15|38.35|<0.0001
91495417|NCT00357968|182863013|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91495418|NCT00357968|182863014|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Fisher Exact|||||||0.0629
91495419|NCT00357968|182863015|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||Fisher Exact|||||||0.1827
91495420|NCT00357968|182863016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.3|||<|0.0001|TWO_SIDED|95.0|-61.2|-47.4|||ANCOVA|||||-47.4|-61.2|<0.0001
91495421|NCT00357968|182863017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-60.5|||<|0.0001|TWO_SIDED|95.0|-67.1|-54.0|||ANCOVA|||||-54.0|-67.1|<0.0001
91495422|NCT00357968|182863018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.2|||<|0.0001|TWO_SIDED|95.0|-63.2|-49.2|||ANCOVA|||||-49.2|-63.2|<0.0001
91495423|NCT00357968|182863019|SUPERIORITY_OR_OTHER||LS Mean difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.5|||Mixed Models Analysis|||||-14.5|-25.7|<0.0001
91495424|NCT00357968|182863020|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.7058|TWO_SIDED|95.0|-2.95|2.0|||ANCOVA|||||2.00|-2.95|0.7058
91495425|NCT00357968|182863021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.33||||0.4029|TWO_SIDED|95.0|-4.48|1.82|||ANCOVA|||||1.82|-4.48|0.4029
91495426|NCT00357968|182863022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.7893|TWO_SIDED|95.0|-0.06|0.08|||ANCOVA|||||0.08|-0.06|0.7893
91495427|NCT00357968|182863023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.4528|TWO_SIDED|95.0|-0.25|0.07|||ANCOVA|||||0.07|-0.25|0.4528
91495428|NCT03919799|182863024|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|1.06||||0.9472|TWO_SIDED|95.0|0.19|5.82||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg QD versus Placebo||5.82|0.19|0.9472
91495429|NCT03919799|182863024|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|0.39||||0.3078|TWO_SIDED|95.0|0.07|2.35||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg BID versus Placebo||2.35|0.07|0.3078
91495430|NCT03919799|182863025|SUPERIORITY|MMRM analysis used rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-0.04||||0.9889|TWO_SIDED|95.0|-6.51|6.42||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||6.42|-6.51|0.9889
91495431|NCT03919799|182863025|SUPERIORITY|MMRM analysis using rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-4.18||||0.1916|TWO_SIDED|95.0|-10.59|2.23||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||2.23|-10.59|0.1916
91495432|NCT03919799|182863027|SUPERIORITY||Least square mean difference|-0.6||||0.771|TWO_SIDED|95.0|-4.7|3.6||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||3.6|-4.7|0.7710
91495433|NCT03919799|182863027|SUPERIORITY||Least square mean difference|4.6||||0.0308|TWO_SIDED|95.0|0.5|8.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||8.8|0.5|0.0308
91495434|NCT03919799|182863028|SUPERIORITY||Least square mean difference|1.4||||0.6533|TWO_SIDED|95.0|-4.9|7.7||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||7.7|-4.9|0.6533
91495435|NCT03919799|182863028|SUPERIORITY||Least square mean difference|-1.5||||0.6338|TWO_SIDED|95.0|-8.1|5.0||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||5.0|-8.1|0.6338
91734732|NCT06028464|183363642|OTHER||Adjusted geometric mean ratio (%)|36.5|||||TWO_SIDED|90.0|31.91|41.74|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 22.3.|Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||41.74|31.91|
91734733|NCT03330847|183363646|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|90.0|0.63|1.66|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.66|0.63|0.9403
91734734|NCT03330847|183363646|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9282|TWO_SIDED|90.0|0.52|1.88|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.88|0.52|0.9282
91734735|NCT03330847|183363646|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.1274|TWO_SIDED|90.0|0.28|1.03|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.03|0.28|0.1274
91734736|NCT03330847|183363646|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.2956|TWO_SIDED|90.0|0.23|1.26|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.26|0.23|0.2956
91734737|NCT03330847|183363646|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2959|TWO_SIDED|90.0|0.5|1.14|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.14|0.50|0.2959
91734738|NCT03330847|183363646|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0193|TWO_SIDED|90.0|0.28|0.8|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||0.80|0.28|0.0193
91495436|NCT03919799|182863029|SUPERIORITY||Least square mean difference|14.6||||0.0916|TWO_SIDED|95.0|-2.5|31.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||31.8|-2.5|0.0916
91495437|NCT03919799|182863029|SUPERIORITY||Least square mean difference|-8.6||||0.3146|TWO_SIDED|95.0|-25.7|8.6|||MMRM|||Belumosudil 200 mg BID versus Placebo||8.6|-25.7|0.3146
91734739|NCT03330847|183363647|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.6147|TWO_SIDED|90.0|0.53|1.39|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population BRCAm||1.39|0.53|0.6147
91530079|NCT01154036|182936471|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.8||||0.001|TWO_SIDED|95.0|-7.8|-1.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.9|-7.8|0.001
91734740|NCT03330847|183363647|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7879|TWO_SIDED|90.0|0.48|1.68|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population BRCAm||1.68|0.48|0.7879
91495438|NCT03919799|182863030|SUPERIORITY||Least square mean difference|-10.0||||0.3753|TWO_SIDED|95.0|-32.8|12.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||12.8|-32.8|0.3753
91495439|NCT03919799|182863030|SUPERIORITY||Least square mean difference|-0.7||||0.9481|TWO_SIDED|95.0|-23.5|22.1||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||22.1|-23.5|0.9481
91495440|NCT03919799|182863031|SUPERIORITY||Least square mean difference|-0.036||||0.8387|TWO_SIDED|95.0|-0.392|0.32||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||0.320|-0.392|0.8387
91495441|NCT03919799|182863031|SUPERIORITY||Least square mean difference|0.039||||0.8234|TWO_SIDED|95.0|-0.317|0.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||0.395|-0.317|0.8234
91530080|NCT01154036|182936472|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.9|||<|0.001|TWO_SIDED|95.0|-11.0|-2.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.8|-11.0|<0.001
91530081|NCT01154036|182936472|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.4|||<|0.001|TWO_SIDED|95.0|-9.4|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-9.4|<0.001
91734741|NCT03330847|183363647|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3695|TWO_SIDED|90.0|0.38|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.31|0.38|0.3695
91734742|NCT03330847|183363647|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.4586|TWO_SIDED|90.0|0.29|1.58|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.58|0.29|0.4586
91734743|NCT03330847|183363647|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.7452|TWO_SIDED|90.0|0.61|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.31|0.61|0.7452
91734744|NCT03330847|183363647|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.1185|TWO_SIDED|90.0|0.37|1.0|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||1.00|0.37|0.1185
91734745|NCT01346592|183363663|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|2.44|||||TWO_SIDED|97.6|2.06|2.9||||||||2.9|2.06|
91734746|NCT01346592|183363663|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|1.89|||||TWO_SIDED|97.6|1.69|2.1||||||||2.1|1.69|
91734747|NCT01346592|183363663|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.07|||||TWO_SIDED|97.6|2.66|3.54||||||||3.54|2.66|
91734748|NCT01346592|183363663|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|3.2|||||TWO_SIDED|97.6|2.7|3.8||||||||3.8|2.7|
91495442|NCT03919799|182863032|SUPERIORITY||Least square mean difference|-3.009||||0.7535|TWO_SIDED|95.0|-22.413|16.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||16.395|-22.413|0.7535
91495443|NCT03919799|182863032|SUPERIORITY||Least square mean difference|-21.015||||0.0348|TWO_SIDED|95.0|-40.419|-1.611||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||-1.611|-40.419|0.0348
91734749|NCT01346592|183363663|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|2.38|||||TWO_SIDED|97.6|2.14|2.65||||||||2.65|2.14|
91734750|NCT01346592|183363663|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.14|||||TWO_SIDED|97.6|2.72|3.62||||||||3.62|2.72|
91734751|NCT01346592|183363664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%.|Group difference (H1N1 strain)|9.09|||||TWO_SIDED|97.6|5.48|12.69||||||||12.69|5.48|
91734752|NCT01346592|183363664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%|Group difference (H3N2 strain)|4.07|||||TWO_SIDED|97.6|1.58|6.55||||||||6.55|1.58|
91495444|NCT03919799|182863033|SUPERIORITY||Least square mean difference|45.566||||0.0343|TWO_SIDED|95.0|3.621|87.512||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||87.512|3.621|0.0343
91495445|NCT03919799|182863033|SUPERIORITY||Least square mean difference|-21.984||||0.2922|TWO_SIDED|95.0|-63.93|19.962||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||19.962|-63.930|0.2922
91495446|NCT03919799|182863034|SUPERIORITY||Least square mean difference|-16.757||||0.532|TWO_SIDED|95.0|-70.933|37.419||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||37.419|-70.933|0.5320
91495447|NCT03919799|182863034|SUPERIORITY||Least square mean difference|4.02||||0.8804|TWO_SIDED|95.0|-50.156|58.196||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||58.196|-50.156|0.8804
91495448|NCT03919799|182863035|SUPERIORITY||Least square mean difference|7.522||||0.8628|TWO_SIDED|95.0|-80.837|95.88||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||95.880|-80.837|0.8628
91495449|NCT03919799|182863035|SUPERIORITY||Least square mean difference|-42.442||||0.3196|TWO_SIDED|95.0|-128.242|43.359|||MMRM|||Belumosudil 200 mg BID versus Placebo||43.359|-128.242|0.3196
91495450|NCT02142959|182863095|SUPERIORITY||LS Mean Difference Final Values|-0.1||||0.237|TWO_SIDED|65.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factors: treatment grp \& wk of visit; covariates of site, smoking status \& surgery. Missing data imputed using each patient's worst-observation.||Comparison of omaveloxolone lotion pooled (0.5% and 3%) versus vehicle lotion||0.0|-0.2|0.237
91495451|NCT02142959|182863095|SUPERIORITY||LS Mean Difference Final Values|-0.1|||>|0.05|TWO_SIDED|95.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 0.5% versus Vehicle Lotion||0.0|-0.2|>0.05
91495452|NCT02142959|182863095|SUPERIORITY||LS Mean Difference Final Values|0.0|||>|0.05|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 3% versus Vehicle Lotion||0.1|-0.1|>0.05
91495453|NCT02970422|182863096|OTHER|||||||0.91|||||||Chi-squared|Chi-squared value= .57||Relief of breathlessness||||.91
91530082|NCT01154036|182936473|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-13.7|||<|0.001|TWO_SIDED|95.0|-18.1|-9.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-9.3|-18.1|<0.001
91495454|NCT02970422|182863096|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.56||Improve your ability to perform activities in and out of your home||||.31
91530083|NCT01154036|182936473|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.8|||<|0.001|TWO_SIDED|95.0|-11.9|-3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.6|-11.9|<0.001
91530084|NCT01154036|182936474|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.4|||<|0.001|TWO_SIDED|95.0|-15.8|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-15.8|<0.001
91530085|NCT01154036|182936474|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.3|||<|0.001|TWO_SIDED|95.0|-12.5|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.5|<0.001
91734753|NCT01346592|183363664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.82|||||TWO_SIDED|97.6|8.72|14.92||||||||14.92|8.72|
91495455|NCT02970422|182863096|OTHER|||||||0.96|||||||Chi-squared|Chi-squared value=.32||Prevent lung flare-ups||||.96
91495456|NCT02970422|182863096|OTHER|||||||0.04|||||||Chi-squared|Chi-squared value= 8.09||Discuss COPD and its progression||||.04
91495457|NCT02970422|182863096|OTHER|||||||0.7|||||||Chi-squared|Chi-squared value: 1.41||Improve your physical well-being||||.70
91495458|NCT02970422|182863096|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 10.81||Relief of breathlessness||||.01
91495459|NCT02970422|182863096|OTHER|||||||0.49|||||||Chi-squared|Chi-squared value= 2.41||Improve your ability to perform activities in and out of your home||||.49
91495460|NCT02970422|182863096|OTHER|||||||0.93|||||||Chi-squared|Chi-squared value= .44||Prevent lung flare-ups||||.93
91495461|NCT02970422|182863096|OTHER|||||||0.6|||||||Chi-squared|Chi-squared value= 1.87||Discuss COPD and its progression||||.60
91495462|NCT02970422|182863096|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.61||Improve your physical well-being||||.31
91495463|NCT02970422|182863097|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value: 1.31||To relieve breathlessness in adults living with COPD||||.73
91495464|NCT02970422|182863097|OTHER|||||||0.23|||||||Chi-squared|Chi-squared value= 4.28||To prevent the development of COPD||||.23
91495465|NCT02970422|182863097|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.51||To prevent lung flare-ups in adults living with COPD||||.14
91495466|NCT02970422|182863097|OTHER|||||||0.52|||||||Chi-squared|Chi-squared value= 2.28||To increase the ability of adults living with COPD to exercise||||.52
91495467|NCT02970422|182863097|OTHER|||||||0.11|||||||Chi-squared|Chi-squared value= 5.88||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.11
91495468|NCT02970422|182863097|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.57||To relieve breathlessness in adults living with COPD||||.14
91495469|NCT02970422|182863097|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value= 1.29||To prevent the development of COPD||||.73
91495470|NCT02970422|182863097|OTHER|||||||0.2|||||||Chi-squared|Chi-squared value= 4.64||To prevent lung flare-ups in adults living with COPD||||.20
91495471|NCT02970422|182863097|OTHER|||||||0.17|||||||Chi-squared|Chi-squared value= 5.02||To increase the ability of adults living with COPD to exercise||||.17
91495472|NCT02970422|182863097|OTHER|||||||0.02|||||||Chi-squared|Chi-square value= 9.97||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.02
91495473|NCT02970422|182863098|OTHER|||||||0.05|||||||Chi-squared|Chi squared value= 17.20||Activity 1: Walking from one place to another outside of your home on a flat surface||||.05
91495474|NCT02970422|182863098|OTHER|||||||0.87|||||||Chi-squared|Chi-squared value= 4.56||Activity 2: Moving from one place to another using motorized transportation||||.87
91495475|NCT02970422|182863098|OTHER|||||||0.65|||||||Chi-squared|Chi-squared value= 6.85||Activity 3: Climbing two or more flights of stairs||||.65
91495476|NCT02970422|182863098|OTHER|||||||0.35|||||||Chi-squared|Chi-squared value= 10.00||Activity 4: Walking up a hill||||.35
91495477|NCT02970422|182863098|OTHER|||||||0.03|||||||Chi-squared|Chi-squared value= 18.75||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.03
91495478|NCT02970422|182863098|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 35.52||Activity 1: Walking from one place to another outside of your home on a flat surface||||.00
91495479|NCT02970422|182863098|OTHER|||||||0.33|||||||Chi-squared|Chi-squared value= 10.23||Activity 2: Moving from one place to another using motorized transportation||||.33
91495480|NCT02970422|182863098|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 23.94||Activity 3: Climbing two or more flights of stairs||||.00
91495481|NCT02970422|182863098|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 22.80||Activity 4: Walking up a hill||||.01
91495482|NCT02970422|182863098|OTHER|||||||0.02|||||||Chi-squared|Chi-squared value= 20.43||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.02
91495483|NCT02970422|182863099|OTHER|||||||0|||||||Kruskal-Wallis|Non-parametric led to equal variance (levene's test) which couldn't be assumed, independent samples were taken (Kruskal-Wallis)|||F(3,144)=137.82|||.00
91530086|NCT01154036|182936475|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.3|||<|0.001|TWO_SIDED|95.0|-10.0|-2.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.5|-10.0|<0.001
91530087|NCT01154036|182936475|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-3.5||||0.052|TWO_SIDED|95.0|-7.1|0.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.0|-7.1|0.052
91530088|NCT01154036|182936476|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8||||0.024|TWO_SIDED|95.0|-10.8|-0.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-0.8|-10.8|0.024
91530089|NCT01154036|182936476|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.1||||0.002|TWO_SIDED|95.0|-9.9|-2.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.3|-9.9|0.002
91530090|NCT01154036|182936477|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.6|||<|0.001|TWO_SIDED|95.0|-14.9|-6.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.4|-14.9|<0.001
91495484|NCT02970422|182863100|OTHER|||||||0|||||||ANOVA|Factorial ANOVA used because variance could be assumed|||F(3,144)=55.89 Partial ETA squared (effect size)=0.54|||.000
91495485|NCT02970422|182863101|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,142)=7.61|||.00
91495486|NCT02970422|182863102|OTHER|||||||0.31|||||||ANOVA|One-way ANOVA|||F(3,142)=1.21|||.31
91495487|NCT02970422|182863103|OTHER|||||||0.04|||||||Kruskal-Wallis|Non-parametric independent sample Kruskal-Wallis test (failed variance assumed|||F(3,139)=8.09|||.04
91495488|NCT02970422|182863104|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,143)=8.01|||.00
91495489|NCT00646776|182863117|SUPERIORITY_OR_OTHER||Point Estimate|1.477|||||TWO_SIDED|90.0|1.188|1.835|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.835|1.188|
91495490|NCT00646776|182863118|SUPERIORITY_OR_OTHER||Point Estimate|2.489|||||TWO_SIDED|90.0|2.025|3.06|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||3.060|2.025|
91495491|NCT00646776|182863119|SUPERIORITY_OR_OTHER||Point Estimate|1.402|||||TWO_SIDED|90.0|1.052|1.867|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.867|1.052|
91495492|NCT00646776|182863120|SUPERIORITY_OR_OTHER||Point Estimate|0.947|||||TWO_SIDED|90.0|0.817|1.098|||ANOVA|||||1.098|0.817|
91495493|NCT00646776|182863121|SUPERIORITY_OR_OTHER||Point Estimate|0.745||||0.0963|TWO_SIDED|90.0|0.5569|0.9967|||ANOVA|||||0.9967|0.5569|0.0963
91495494|NCT00646776|182863122|SUPERIORITY_OR_OTHER||Point Estimate|0.857|||||TWO_SIDED|90.0|0.723|1.015|||ANOVA|||||1.015|0.723|
91495495|NCT00646776|182863125|SUPERIORITY_OR_OTHER||Point Estimate|0.66|||||TWO_SIDED|90.0|0.538|0.809|||ANOVA|||||0.809|0.538|
91495496|NCT00646776|182863126|SUPERIORITY_OR_OTHER||Point Estimate|0.651|||||TWO_SIDED|90.0|0.43|0.986|||ANOVA|||||0.986|0.430|
91495497|NCT00646776|182863127|SUPERIORITY_OR_OTHER||Point Estimate|0.696|||||TWO_SIDED|90.0|0.563|0.862|||ANOVA|||||0.862|0.563|
91495498|NCT00646776|182863133|SUPERIORITY_OR_OTHER||Point Estimate|10.902|||||TWO_SIDED|90.0|8.135|14.61|||ANOVA|||||14.610|8.135|
91495499|NCT00646776|182863134|SUPERIORITY_OR_OTHER||Point Estimate|7.766|||||TWO_SIDED|90.0|6.133|9.833|||ANCOVA|||||9.833|6.133|
91495500|NCT00646776|182863135|SUPERIORITY_OR_OTHER||Point Estimate|11.451|||||TWO_SIDED|90.0|8.147|16.095|||ANOVA|||||16.095|8.147|
91495501|NCT00646776|182863136|SUPERIORITY_OR_OTHER||Point Estimate|2.19|||||TWO_SIDED|90.0|1.783|2.691|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||2.691|1.783|
91495502|NCT01753856|182863149|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
91495503|NCT01753856|182863150|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in CC.|Fisher Exact|||||||<0.001
91495504|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||SL Only, in CC.|Fisher Exact|||||||0.002
91495505|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.494|TWO_SIDED|||||No Label, in CC.|Fisher Exact|||||||0.494
91734754|NCT01346592|183363664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|14.21|||||TWO_SIDED|97.6|10.3|18.13||||||||18.13|10.3|
91734755|NCT01346592|183363664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H3N2 strain)|7.31|||||TWO_SIDED|97.6|4.47|10.14||||||||10.14|4.47|
91734756|NCT01346592|183363664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.1|||||TWO_SIDED|97.6|8.11|14.1||||||||14.1|8.11|
91734757|NCT01346592|183363665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|Group ratio (H1N1 strain)|0.76|||||TWO_SIDED|97.4|0.62|0.93||||||||0.93|0.62|
91734758|NCT01346592|183363665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (H3N2 strain)|0.77|||||TWO_SIDED|97.4|0.68|0.86||||||||0.86|0.68|
91734759|NCT01346592|183363665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (B strain)|0.94|||||TWO_SIDED|97.4|0.8|1.11||||||||1.11|0.8|
91734760|NCT01346592|183363666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H1N1 strain)|-5.3|||||TWO_SIDED|97.4|-10.13|-0.47||||||||-0.47|-10.13|
91734761|NCT01346592|183363666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H3N2 strain)|-2.84|||||TWO_SIDED|97.4|-6.16|0.5||||||||0.5|-6.16|
91734762|NCT01346592|183363666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (B strain)|-2.49|||||TWO_SIDED|97.4|-7.01|2.0||||||||2|-7.01|
91495506|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||DL and SL, in EC.|Fisher Exact|||||||0.001
91495507|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||SL Only, in EC.|Fisher Exact|||||||0.027
91495508|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED|||||No Label, in EC.|Fisher Exact|||||||0.118
91495509|NCT01753856|182863150|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in IC.|Fisher Exact|||||||<0.001
91495510|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||SL Only, in IC.|Fisher Exact|||||||0.001
91495511|NCT01753856|182863150|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||No Label, in IC.|Fisher Exact|||||||>0.999
91495512|NCT01753856|182863150|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL and SL, in PC.|Fisher Exact|||||||0.002
91495513|NCT01753856|182863150|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SL Only, in PC.|Fisher Exact|||||||<0.001
91495514|NCT01753856|182863150|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No Label, in PC.|Fisher Exact|||||||<0.001
91734763|NCT01346592|183363667|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.63|||||TWO_SIDED|95.0|2.86|4.6||||||Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||4.6|2.86|
91734764|NCT01346592|183363667|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.25|||||TWO_SIDED|95.0|1.96|2.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.59|1.96|
91734765|NCT01346592|183363667|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
91734766|NCT01346592|183363667|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|5.28|||||TWO_SIDED|95.0|4.16|6.7||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||6.7|4.16|
91734767|NCT01346592|183363667|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|3.1|||||TWO_SIDED|95.0|2.69|3.56||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.56|2.69|
91734768|NCT01346592|183363667|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
91495515|NCT01753856|182863151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
91495516|NCT01753856|182863151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
91530091|NCT01154036|182936477|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.2||||0.002|TWO_SIDED|95.0|-10.2|-2.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.2|-10.2|0.002
91530092|NCT01154036|182936478|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.8|-3.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.9|-14.8|<0.001
91495517|NCT01753856|182863151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
91495518|NCT01753856|182863152|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495519|NCT01753856|182863152|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495520|NCT01753856|182863152|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495521|NCT01753856|182863152|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495522|NCT01753856|182863153|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Remodeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
91495523|NCT01753856|182863153|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Modeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
91495524|NCT01753856|182863153|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Remodeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
91495525|NCT01753856|182863153|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Modeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
91495526|NCT01753856|182863153|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Remodeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
91495527|NCT01753856|182863153|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Modeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
91495528|NCT01753856|182863155|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495529|NCT01753856|182863155|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495530|NCT01753856|182863155|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||0.740
91495531|NCT01753856|182863156|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495532|NCT01753856|182863156|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
91495533|NCT01753856|182863156|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495534|NCT01753856|182863156|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.850
91495535|NCT01753856|182863157|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
91495536|NCT01753856|182863157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in the CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495537|NCT01753856|182863157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495538|NCT01753856|182863157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495539|NCT01753856|182863157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495540|NCT01753856|182863157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495541|NCT01753856|182863157|SUPERIORITY_OR_OTHER|||||||0.931|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.931
91495542|NCT01753856|182863157|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.549
91495543|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495544|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495545|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495546|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495547|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495548|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495549|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495550|NCT01753856|182863158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495551|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495552|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495553|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91734769|NCT01346592|183363668|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|10.4|||||TWO_SIDED|95.0|6.1|14.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||14.7|6.1|
91734770|NCT01346592|183363668|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|2.5|||||TWO_SIDED|95.0|-0.12|5.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.1|-0.12|
91734771|NCT01346592|183363668|SUPERIORITY_OR_OTHER||Group difference (B strain)|12.8|||||TWO_SIDED|95.0|8.9|16.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||16.7|8.9|
91734772|NCT01346592|183363668|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|17.7|||||TWO_SIDED|95.0|12.9|22.6||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||22.6|12.9|
91734773|NCT01346592|183363668|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|5.6|||||TWO_SIDED|95.0|2.5|8.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||8.7|2.5|
91734774|NCT01346592|183363668|SUPERIORITY_OR_OTHER||Group difference (B strain)|18.8|||||TWO_SIDED|95.0|14.4|23.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||23.1|14.4|
91734775|NCT01346592|183363669|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|2.38|||||TWO_SIDED|95.0|2.07|2.75||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.75|2.07|
91734776|NCT01346592|183363669|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|1.88|||||TWO_SIDED|95.0|1.72|2.06||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.06|1.72|
91495554|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495555|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495556|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495557|NCT01753856|182863159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
91495558|NCT01753856|182863159|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||dLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.028
91495559|NCT01753856|182863160|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495560|NCT01753856|182863160|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495561|NCT01753856|182863160|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495562|NCT01753856|182863161|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495563|NCT01753856|182863161|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495564|NCT01753856|182863161|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495565|NCT01753856|182863162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495566|NCT01753856|182863162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495567|NCT01753856|182863162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495568|NCT01753856|182863163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495569|NCT01753856|182863163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495570|NCT01753856|182863163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495571|NCT01753856|182863164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495572|NCT01753856|182863164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495573|NCT01753856|182863164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495574|NCT01753856|182863164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495575|NCT01753856|182863164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495576|NCT01753856|182863164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495577|NCT01753856|182863165|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||0.002
91495578|NCT01753856|182863165|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495579|NCT01753856|182863165|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||0.214
91495580|NCT01753856|182863165|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||0.031
91495581|NCT01753856|182863165|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495582|NCT01753856|182863165|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495583|NCT01753856|182863166|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91495584|NCT01753856|182863167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495585|NCT01753856|182863167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495586|NCT01753856|182863167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495587|NCT01753856|182863168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495588|NCT01753856|182863168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495589|NCT01753856|182863168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495590|NCT01753856|182863169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of DLs in the CC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
91495591|NCT01753856|182863169|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Average length of double labels in EC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.004
91495592|NCT01753856|182863169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of double labels in IC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
91495593|NCT01753856|182863169|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||Average length of double labels in the PC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.850
91495594|NCT01753856|182863170|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
91495595|NCT01753856|182863170|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||0.042
91495596|NCT01753856|182863170|SUPERIORITY_OR_OTHER|||||||0.678|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||0.678
91495597|NCT01753856|182863171|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC|Wilcoxon (Mann-Whitney)|||||||<0.001
91495598|NCT01753856|182863171|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC|Wilcoxon (Mann-Whitney)|||||||<0.001
91495599|NCT01753856|182863171|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC|Wilcoxon (Mann-Whitney)|||||||<0.001
91495600|NCT02324569|182863224|SUPERIORITY||Least square (LS) mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.826|-0.443|||ANCOVA|||||-0.443|-0.826|<0.0001
91495601|NCT02016560|182863234|OTHER||Cox Proportional Hazard|1.581||||0.067|TWO_SIDED|95.0|0.968|2.581||A p-value of \<0.05 was the a priori threshold for statistical significance.|Cox proportional hazards|The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.||The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).||2.581|0.968|0.067
91495602|NCT02016560|182863235|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and Older Cognitively Healthy within amyloid positive group.||||<0.0001
91495603|NCT02016560|182863235|OTHER|||||||0.0622||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between MCI and Older Cognitively Healthy within the amyloid positive group.||||0.0622
91495604|NCT02016560|182863235|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and MCI within the amyloid positive group.||||<0.0001
91495605|NCT02016560|182863236|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero|||||<|0.0001|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid positive subjects only.||||<0.0001
91495606|NCT02016560|182863236|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero||||||0.7851|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid negative subjects only.||||0.7851
91495607|NCT02016560|182863237|OTHER||||||||||||||||||The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% confidence intervals ≥50%, for both sensitivity and specificity.|||
91495608|NCT02016560|182863238|OTHER||Pearson's correlation coefficient|-0.0925||||0.4361|TWO_SIDED||||||Pearson|||Pearson's correlation coefficient||||0.4361
91495609|NCT03758274|182863239|SUPERIORITY|||||||0.746|||||||Based on simple path model in Mplus.|||||||0.746
91495610|NCT03758274|182863240|SUPERIORITY|||||||0.247|||||||Based on simple path model in Mplus.|||||||0.247
91495611|NCT03758274|182863241|SUPERIORITY|||||||0.689|||||||Chi-squared|||||||0.689
91495612|NCT00842712|182863306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.718||||0.0845|TWO_SIDED|95.0|0.492|1.048|||Log Rank|||PFS Time: Independent read||1.048|0.492|0.0845
91495613|NCT00842712|182863307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.5912|TWO_SIDED|95.0|0.642|1.286|||Log Rank|||||1.286|0.642|0.5912
91495614|NCT00842712|182863308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2648|TWO_SIDED|95.0|0.564|1.171|||Log Rank|||||1.171|0.564|0.2648
91495615|NCT00309387|182863351|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.03|TWO_SIDED|95.0|0.68|0.98|||Regression, Cox|||||0.98|0.68|0.03
91495616|NCT00208091|182863359|SUPERIORITY_OR_OTHER||||||=|0.06||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.06
91495617|NCT00208091|182863360|SUPERIORITY_OR_OTHER||||||=|0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.23
91495618|NCT02899988|182863362|SUPERIORITY||Risk Difference (RD)|29.4||||0.009|TWO_SIDED|95.0|16.9|41.9|||Regression, Logistic|||||41.9|16.9|0.009
91495619|NCT02899988|182863362|SUPERIORITY||Risk Difference (RD)|58.8|||<|0.001|TWO_SIDED|95.0|45.3|72.3|||Regression, Logistic|||||72.3|45.3|<0.001
91734777|NCT01346592|183363669|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|2.93|||||TWO_SIDED|95.0|2.6|3.3||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.3|2.6|
91734778|NCT01346592|183363669|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|3.21|||||TWO_SIDED|95.0|2.79|3.71||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.71|2.79|
91734779|NCT01346592|183363669|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.19|2.62||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.62|2.19|
91734780|NCT01346592|183363669|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.73|3.47||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.47|2.73|
91734781|NCT01346592|183363670|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.3|||||TWO_SIDED|95.0|6.3|12.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||12.4|6.3|
91734782|NCT01346592|183363670|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|3.9|||||TWO_SIDED|95.0|1.8|5.9||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.9|1.8|
91734783|NCT01346592|183363670|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.7|||||TWO_SIDED|95.0|8.1|13.3||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.3|8.1|
91734784|NCT01346592|183363670|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|14.4|||||TWO_SIDED|95.0|11.1|17.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||17.7|11.1|
91734785|NCT01346592|183363670|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|6.8|||||TWO_SIDED|95.0|4.5|9.1||||||superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||9.1|4.5|
91495620|NCT02899988|182863362|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.7|79.6|||Regression, Logistic|||||79.6|53.7|<0.001
91495621|NCT02899988|182863363|SUPERIORITY||Risk Difference (RD)|15.7||||0.039|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||||25.7|5.7|0.039
91734786|NCT01346592|183363670|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.9|||||TWO_SIDED|95.0|8.3|13.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.4|8.3|
91734787|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.68|||||TWO_SIDED|95.0|2.3|3.12||||||No risk subjects.||3.12|2.3|
91495622|NCT02899988|182863363|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
91495623|NCT02899988|182863363|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
91734788|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.87|||||TWO_SIDED|95.0|1.7|2.05||||||No risk subjects.||2.05|1.7|
91734789|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.04|||||TWO_SIDED|95.0|2.68|3.44||||||No risk subjects.||3.44|2.68|
91495624|NCT02899988|182863364|SUPERIORITY||Risk Difference (RD)|22.49|||<|0.001|TWO_SIDED|95.0|5.62|89.97|||Regression, Logistic|||||89.97|5.62|<0.001
91495625|NCT02899988|182863364|SUPERIORITY||Risk Difference (RD)|74.6|||<|0.001|TWO_SIDED|95.0|62.1|87.0|||Regression, Logistic|||||87.0|62.1|<0.001
91734790|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.21|||||TWO_SIDED|95.0|1.11|4.42||||||At risk subjects.||4.42|1.11|
91495626|NCT02899988|182863364|SUPERIORITY||Risk Difference (RD)|70.7|||<|0.001|TWO_SIDED|95.0|57.6|83.7|||Regression, Logistic|||||83.7|57.6|<0.001
91495627|NCT02899988|182863365|SUPERIORITY||Risk Difference (RD)|15.7||||0.041|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||sPGA (0)||25.7|5.7|0.041
91734791|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.45|||||TWO_SIDED|95.0|1.61|3.72||||||At risk subjects.||3.72|1.61|
91734792|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.46|||||TWO_SIDED|95.0|1.88|6.34||||||At risk subjects||6.34|1.88|
91734793|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratios (H1N1 strain)|3.52|||||TWO_SIDED|95.0|3.03|4.1||||||No risk subjects.||4.1|3.03|
91734794|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.36|||||TWO_SIDED|95.0|2.15|2.59||||||No risk subjects.||2.59|2.15|
91734795|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.14|||||TWO_SIDED|95.0|2.78|3.56||||||No risk subjects.||3.56|2.78|
91495628|NCT02899988|182863365|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.007
91495629|NCT02899988|182863365|SUPERIORITY||Risk Difference (RD)|31.4||||0.008|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.008
91495630|NCT02899988|182863365|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.001|TWO_SIDED|95.0|21.5|49.1|||Regression, Logistic|||sPGA (0/1)||49.1|21.5|<0.001
91495631|NCT02899988|182863365|SUPERIORITY||Risk Difference (RD)|68.7|||<|0.001|TWO_SIDED|95.0|55.6|81.7|||Regression, Logistic|||sPGA (0/1)||81.7|55.6|<0.001
91495632|NCT02899988|182863365|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Regression, Logistic|||sPGA (0/1)||80.0|53.4|<0.001
91495633|NCT02899988|182863366|SUPERIORITY||Mean Difference (Net)|-26.84|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495634|NCT02899988|182863366|SUPERIORITY||Mean Difference (Net)|-37.99|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495635|NCT02899988|182863366|SUPERIORITY||Mean Difference (Net)|-29.32|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495636|NCT02899988|182863367|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495637|NCT02899988|182863367|SUPERIORITY||Mean Difference (Net)|2.56|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495638|NCT02899988|182863367|SUPERIORITY||Mean Difference (Net)|2.47|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91530093|NCT01154036|182936478|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.4|||<|0.001|TWO_SIDED|95.0|-12.6|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.6|<0.001
91530094|NCT01154036|182936479|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-3.9||||0.613|TWO_SIDED|95.0|-18.9|11.1|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||11.1|-18.9|0.613
91530095|NCT01154036|182936479|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-1.5||||0.831|TWO_SIDED|95.0|-15.7|12.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||12.6|-15.7|0.831
91495639|NCT02899988|182863368|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495640|NCT02899988|182863368|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495641|NCT02899988|182863368|SUPERIORITY||Mean Difference (Net)|-8.57|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91495642|NCT02899988|182863369|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.24||0.009|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.009
91495643|NCT02899988|182863369|SUPERIORITY||Mean Difference (Net)|2.74|STANDARD_ERROR_OF_MEAN|1.22||0.002|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.002
91495644|NCT02899988|182863369|SUPERIORITY||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.24||0.087|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.087
91495645|NCT02899988|182863369|SUPERIORITY||Mean Difference (Net)|3.35|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
91495646|NCT02899988|182863369|SUPERIORITY||Mean Difference (Net)|3.16|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
91495647|NCT02899988|182863369|SUPERIORITY||Mean Difference (Net)|3.86|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
91495648|NCT03454581|182863377|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
91495649|NCT03454581|182863378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
91495650|NCT03454581|182863379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
91495651|NCT03454581|182863380|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Generalized Estimating Equation|||||||<0.05
91495652|NCT03454581|182863381|OTHER||||||<|0.01|||||||Generalized Estimating Equation|||||||<0.01
91495653|NCT03454581|182863382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
91495654|NCT03454581|182863383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
91495655|NCT03454581|182863384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
91495656|NCT00411645|182863393|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.902||||0.789|TWO_SIDED|95.0|0.424|1.92||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|||1.920|0.424|0.789
91495657|NCT00411645|182863394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.721||||0.056|TWO_SIDED|95.0|0.515|1.008||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||1.008|0.515|0.056
91495658|NCT00411645|182863394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.979||||0.904|TWO_SIDED|95.0|0.697|1.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.375|0.697|0.904
91495659|NCT00411645|182863394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.838||||0.289|TWO_SIDED|95.0|0.606|1.161||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia or CMV DNA PCR assay||1.161|0.606|0.289
91495660|NCT00411645|182863394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.891||||0.493|TWO_SIDED|95.0|0.64|1.239||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.239|0.640|0.493
91734796|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.7|||||TWO_SIDED|95.0|1.28|5.68||||||At risk subjects.||5.68|1.28|
91734797|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.25|||||TWO_SIDED|95.0|2.09|5.06||||||At risk subjects.||5.06|2.09|
91734798|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.76|||||TWO_SIDED|95.0|1.44|5.3||||||At risk subjects.||5.3|1.44|
91734799|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.81|||||TWO_SIDED|95.0|2.34|3.37||||||No risk subjects.||3.37|2.34|
91734800|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.04|||||TWO_SIDED|95.0|1.83|2.28||||||No risk subjects.||2.28|1.83|
91734801|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.74|||||TWO_SIDED|95.0|3.22|4.34||||||No risk subjects||4.34|3.22|
91734802|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.34|||||TWO_SIDED|95.0|0.92|6.0||||||At risk subjects.||6|0.92|
91734803|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.93|||||TWO_SIDED|95.0|1.57|5.45||||||At risk subjects.||5.45|1.57|
91734804|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.55|||||TWO_SIDED|95.0|2.52|12.0||||||At risk subjects||12|2.52|
91734805|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.66|||||TWO_SIDED|95.0|3.05|4.39||||||No risk subjects.||4.39|3.05|
91734806|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.68|||||TWO_SIDED|95.0|2.4|2.99||||||No risk subjects||2.99|2.4|
91495661|NCT00411645|182863395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129|TWO_SIDED||||||Log Rank|||||||0.129
91495662|NCT00411645|182863395|SUPERIORITY_OR_OTHER_LEGACY||Adjusted hazard ratio|0.83||||0.13|TWO_SIDED|95.0|0.65|1.06||The p-value from Wald Chi-Square test for treatment effect.|Wald Chi-squared||Maribavir versus placebo; based on Cox's proportional hazards regression model: time = recipient CMV serostatus (R+ or R-) + transplant type (myeloablative or non-myeloablative/reduced intensity) + treatment.|||1.06|0.65|0.130
91530096|NCT01154036|182936480|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.1||||0.187|TWO_SIDED|95.0|-32.6|6.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||6.4|-32.6|0.187
91734807|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.97|||||TWO_SIDED|95.0|3.42|4.61||||||No risk subjects.||4.61|3.42|
91495663|NCT00411645|182863396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.542
91530097|NCT01154036|182936480|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.6||||0.153|TWO_SIDED|95.0|-27.7|4.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.4|-27.7|0.153
91495664|NCT00411645|182863396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.637
91495665|NCT00411645|182863396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.825|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 12 months post-transplant||||0.825
91734808|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.72|||||TWO_SIDED|95.0|1.02|7.31||||||At risk subjects.||7.31|1.02|
91734809|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.5|||||TWO_SIDED|95.0|1.85|6.62||||||At risk subjects.||6.62|1.85|
91734810|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.26|||||TWO_SIDED|95.0|2.32|12.0||||||At risk subjects.||12|2.32|
91734811|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.55|||||TWO_SIDED|95.0|1.21|1.97||||||No risk subjects.||1.97|1.21|
91734812|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.51|||||TWO_SIDED|95.0|1.26|1.82||||||No risk subjects||1.82|1.26|
91734813|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.9|||||TWO_SIDED|95.0|1.52|2.38||||||No risk subjects||2.38|1.52|
91734814|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.76|||||TWO_SIDED|95.0|0.57|5.4||||||At risk subjects||5.4|0.57|
91734815|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.78|||||TWO_SIDED|95.0|1.09|2.89||||||At risk subjects||2.89|1.09|
91734816|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.82|||||TWO_SIDED|95.0|0.73|4.54||||||At risk subjects||4.54|0.73|
91734817|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.4|||||TWO_SIDED|95.0|1.89|3.05||||||No risk subjects||3.05|1.89|
91734818|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.29|1.85||||||No risk subjects.||1.85|1.29|
91734819|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.7|||||TWO_SIDED|95.0|1.36|2.11||||||No risk subjects||2.11|1.36|
91734820|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.12|||||TWO_SIDED|95.0|0.58|7.71||||||At risk subjects.||7.71|0.58|
91734821|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.81|||||TWO_SIDED|95.0|1.61|4.89||||||At risk subjects||4.89|1.61|
91734822|NCT01346592|183363675|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.17|||||TWO_SIDED|95.0|0.37|3.67||||||At risk subjects||3.67|0.37|
91734823|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|9.0|||||TWO_SIDED|95.0|5.4|12.0||||||No risk subjects.||12|5.4|
91734824|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.6||||||No risk subjects.||6.6|1.8|
91530098|NCT00390455|182936481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis then is that the hazard ratio of the two treatment arms is 1.0; the alternative hypothesis is that the hazard ratio of the control to the experimental regimen is 1.5 (0.67). The test of these hypotheses is one-sided (alpha = 0.025), and interim analyses will be used to stop for futility and superiority. Under these assumptions, there is at least 90% power to detect the stated difference in median PFS between the two treatment arms.|Hazard Ratio (HR)|1.04||||0.37|TWO_SIDED|95.0|0.82|1.33||Tests were stratified by prior tamoxifen therapy (yes/no) and bone disease only (yes/no).|Log Rank|||||1.33|0.82|0.37
91734825|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|14.8||||||No risk subjects.||14.8|9.2|
91734826|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-24.0|18.7||||||At risk subjects.||18.7|-24|
91734827|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|1.0|||||TWO_SIDED|95.0|-21.2|18.9||||||At risk subjects.||18.9|-21.2|
91530099|NCT01183650|182936527|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.05|||||TWO_SIDED|90.0|0.84|1.32|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.32|0.84|
91734828|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|14.0|||||TWO_SIDED|95.0|-1.6|29.5||||||At risk subjects.||29.5|-1.6|
91734829|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|14.0|||||TWO_SIDED|95.0|10.7|17.7||||||No risk subjects.||17.7|10.7|
91734830|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects.||9.8|4.6|
91734831|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.7|16.4||||||No risk subjects||16.4|10.7|
91734832|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-3.0|||||TWO_SIDED|95.0|-26.1|19.2||||||At risk subjects.||19.2|-26.1|
91734833|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-17.5|27.3||||||At risk subjects.||27.3|-17.5|
91734834|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|-4.4|29.2||||||At risk subjects.||29.2|-4.4|
91734835|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|11.0|||||TWO_SIDED|95.0|7.2|14.5||||||No risk subjects.||14.5|7.2|
91734836|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.6|7.5||||||No risk subjects.||7.5|2.6|
91734837|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|9.5|15.8||||||No risk subjects.||15.8|9.5|
91734838|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|5.0|||||TWO_SIDED|95.0|-24.7|26.3||||||At risk subjects.||26.3|-24.7|
91734839|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|-26.9|30.3||||||At risk subjects.||30.3|-26.9|
91734840|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-16.9|27.1||||||At risk subjects.||27.1|-16.9|
91734841|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.4|20.2||||||No risk subjects.||20.2|12.4|
91734842|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|5.1|10.5||||||No risk subjects||10.5|5.1|
91734843|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|12.0|18.6||||||No risk subjects||18.6|12|
91734844|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-27.1|25.5||||||At risk subjects||25.5|-27.1|
91734845|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|10.0|||||TWO_SIDED|95.0|-23.5|37.2||||||At risk subjects||37.2|-23.5|
91734846|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|16.0|||||TWO_SIDED|95.0|-10.7|38.0||||||At risk subjects.||38|-10.7|
91734847|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-4.2|10.4||||||No risk subjects.||10.4|-4.2|
91734848|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 subjects)|4.0|||||TWO_SIDED|95.0|-1.2|11.9||||||No risk subjects.||11.9|-1.2|
91734849|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|8.0|||||TWO_SIDED|95.0|2.9|15.1||||||No risk subjects.||15.1|2.9|
91734850|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-42.4|32.0||||||At risk subjects.||32|-42.4|
91734851|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.2|16.6||||||At risk subjects.||16.6|-41.2|
91734852|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|25.0|||||TWO_SIDED|95.0|-7.1|53.9||||||At risk subjects.||53.9|-7.1|
91734853|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|8.0|||||TWO_SIDED|95.0|1.0|16.4||||||No risk subjects.||16.4|1|
91734854|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.0|16.1||||||No risk subjects.||16.1|2|
91734855|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|10.0||||||No risk subjects.||10|0|
91734856|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-42.1|43.0||||||At risk subjects.||43|-42.1|
91734857|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.5|28.7||||||At risk subjects||28.7|-41.5|
91495666|NCT00411645|182863397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.669||||0.022|TWO_SIDED|95.0|0.474|0.946||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||0.946|0.474|0.022
91495667|NCT00411645|182863397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.878||||0.468|TWO_SIDED|95.0|0.617|1.247||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.247|0.617|0.468
91495668|NCT00411645|182863397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.772||||0.125|TWO_SIDED|95.0|0.555|1.075||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay or CMV DNA PCR assay||1.075|0.555|0.125
91495669|NCT00411645|182863397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.731||||0.069|TWO_SIDED|95.0|0.521|1.026||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.026|0.521|0.069
91530100|NCT01183650|182936527|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.8|||||TWO_SIDED|90.0|0.64|1.0|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.00|0.64|
91530101|NCT01183650|182936527|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.31|||||TWO_SIDED|90.0|1.05|1.64|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.64|1.05|
91495670|NCT00411645|182863397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.913||||0.86|TWO_SIDED|95.0|0.332|2.508||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of EC-confirmed disease||2.508|0.332|0.860
91495671|NCT00411645|182863398|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.835||||0.617|TWO_SIDED|95.0|0.411|1.693||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 12 months post-transplant||1.693|0.411|0.617
91530102|NCT01183650|182936527|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.99|||||TWO_SIDED|90.0|0.79|1.24|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.24|0.79|
91530103|NCT01183650|182936528|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.98|||||TWO_SIDED|90.0|0.81|1.18|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means(Japanese/Caucasian)|||1.18|0.81|
91530104|NCT01183650|182936528|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.81|||||TWO_SIDED|90.0|0.67|0.97|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||0.97|0.67|
91530105|NCT01183650|182936528|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.33|||||TWO_SIDED|90.0|1.07|1.67|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.67|1.07|
91495672|NCT00411645|182863399|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.7808|TWO_SIDED|95.0|0.754|1.457||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||1.457|0.754|0.7808
91495673|NCT00411645|182863399|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.068||||0.6946|TWO_SIDED|95.0|0.771|1.479||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.479|0.771|0.6946
91495674|NCT00411645|182863400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.186||||0.6304|TWO_SIDED|95.0|0.592|2.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||2.375|0.592|0.6304
91495675|NCT00411645|182863400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.726||||0.1019|TWO_SIDED|95.0|0.495|1.066||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.066|0.495|0.1019
91495676|NCT02289690|182863420|OTHER||RP2D for veliparib in mg BID for 14 days|240.0|||||TWO_SIDED||||||||The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL\*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.|A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.||||
91495677|NCT02289690|182863436|SUPERIORITY||Hazard Ratio (HR)|0.665||||0.059|TWO_SIDED|80.0|0.503|0.88|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"The primary efficacy analysis in the Phase 2 portion of the study was the comparison of PFS among participants who received veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A) vs. placebo in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm C).~Statistical significance was determined by a two-sided p-value ≤ 0.2"||0.880|0.503|0.059
91495678|NCT02289690|182863436|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.924|TWO_SIDED|80.0|0.744|1.288|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.288|0.744|0.924
91495679|NCT02289690|182863437|SUPERIORITY||Hazard Ratio (HR)|1.432||||0.088|TWO_SIDED|80.0|1.092|1.879|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.879|1.092|0.088
91530106|NCT01183650|182936528|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.83|1.29|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.29|0.83|
91530107|NCT01183650|182936529|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Japanese Participants||||||
91734858|NCT01346592|183363676|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-29.0|36.8||||||At risk subjects.||36.8|-29|
91530108|NCT01183650|182936529|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Caucasian Participants||||||
91530109|NCT01183650|182936529|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|19.83||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Japanese participants||||||
91530110|NCT01183650|182936529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.02||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Caucasian participants||||||
91530111|NCT04827134|182936530|OTHER||Ratio of Geometric Least Square Means|0.88|||||TWO_SIDED|90.0|0.8344|0.9282|||||An analysis of variance (ANOVA) was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9282|0.8344|
91530112|NCT04827134|182936530|OTHER||Ratio of Geometric Least Square Means|0.8578|||||TWO_SIDED|90.0|0.8168|0.9007|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9007|0.8168|
91734859|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|6.4|12.8||||||No risk subjects.||12.8|6.4|
91734860|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.4||||||No risk subjects.||6.4|1.8|
91495680|NCT02289690|182863437|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.083|TWO_SIDED|80.0|1.104|1.931|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.931|1.104|0.083
91495681|NCT02289690|182863438|SUPERIORITY||Odds Ratio (OR)|1.9||||0.115|TWO_SIDED|80.0|1.1|3.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||3.2|1.1|0.115
91495682|NCT02289690|182863438|SUPERIORITY||Odds Ratio (OR)|0.8||||0.604|TWO_SIDED|80.0|0.5|1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.3|0.5|0.604
91495683|NCT00299104|182863451|SUPERIORITY_OR_OTHER|||||||0.0016||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0016
91495684|NCT00299104|182863451|SUPERIORITY_OR_OTHER|||||||0.1824||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status||||0.1824
91495685|NCT00299104|182863451|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0004
91530113|NCT04827134|182936530|OTHER||Ratio of Geometric Least Square Means|0.8919|||||TWO_SIDED|90.0|0.8316|0.9566|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9566|0.8316|
91530114|NCT04827134|182936531|OTHER||Ratio of Geometric Least Square Means|0.8744|||||TWO_SIDED|90.0|0.8293|0.9219|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9219|0.8293|
91530115|NCT04827134|182936531|OTHER||Ratio of Geometric Least Square Means|0.8567|||||TWO_SIDED|90.0|0.8159|0.8995|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.8995|0.8159|
91530116|NCT04827134|182936531|OTHER||Ratio of Geometric Least Square Means|0.8798|||||TWO_SIDED|90.0|0.8202|0.9438|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9438|0.8202|
91530117|NCT04827134|182936532|OTHER||Ratio of Geometric Least Square Means|0.7102|||||TWO_SIDED|90.0|0.6598|0.7643|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7643|0.6598|
91530118|NCT04827134|182936532|OTHER||Ratio of Geometric Least Square Means|0.4503|||||TWO_SIDED|90.0|0.3976|0.51|||||An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.5100|0.3976|
91530119|NCT04827134|182936532|OTHER||Ratio of Geometric Least Square Means|0.6373|||||TWO_SIDED|90.0|0.5594|0.726|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7260|0.5594|
91530120|NCT04827134|182936533|OTHER||Ratio of Geometric Least Square Means|0.9148|||||TWO_SIDED|90.0|0.8834|0.9472|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9472|0.8834|
91530121|NCT04827134|182936533|OTHER||Ratio of Geometric Least Square Means|0.8847|||||TWO_SIDED|90.0|0.8303|0.9426|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9426|0.8303|
91530122|NCT04827134|182936534|OTHER||Ratio of Geometric Least Square Means|0.9163|||||TWO_SIDED|90.0|0.8862|0.9475|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9475|0.8862|
91530123|NCT04827134|182936534|OTHER||Ratio of Geometric Least Square Means|0.8806|||||TWO_SIDED|90.0|0.8251|0.9398|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9398|0.8251|
91495686|NCT00299104|182863452|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0004
91495687|NCT00299104|182863452|SUPERIORITY_OR_OTHER|||||||0.1194||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.1194
91495688|NCT00299104|182863452|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0001
91495689|NCT00299104|182863453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.3803||95.0|-0.05|0.13||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.13|-0.05|0.3803
91530124|NCT04827134|182936535|OTHER||Ratio of Geometric Least Square Means|0.7284|||||TWO_SIDED|90.0|0.6576|0.8068|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.8068|0.6576|
91530125|NCT04827134|182936535|OTHER||Ratio of Geometric Least Square Means|0.5191|||||TWO_SIDED|90.0|0.4535|0.5943|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.5943|0.4535|
91530126|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.23|2.69||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||2.69|-1.23|
91530127|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-1.32|2.29||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||2.29|-1.32|
91530128|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.76|2.08||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.08|-1.76|
91530129|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.09|2.35||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.35|-1.09|
91530130|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.88|2.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.25|-1.88|
91530131|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.47|2.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||2.37|-1.47|
91530132|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.99|1.92||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||1.92|-1.99|
91530133|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|2.39|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|0.35|4.43||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||4.43|0.35|
91530134|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.57|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||2.12|-1.57|
91530135|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-1.15|3.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||3.37|-1.15|
91530136|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-1.52|2.14||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.14|-1.52|
91530137|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|4.81|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|2.84|6.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||6.78|2.84|
91530138|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|0.12|3.73||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||3.73|0.12|
91530139|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.71|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.12|-1.71|
91734861|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|11.0|||||TWO_SIDED|95.0|8.6|13.9||||||No risk subjects.||13.9|8.6|
91734862|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-24.7|14.9||||||At risk subjects.||14.9|-24.7|
91734863|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|-14.4|20.7||||||At risk subjects.||20.7|-14.4|
91734864|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-6.8|23.4||||||At risk subjects.||23.4|-6.8|
91734865|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|15.0|||||TWO_SIDED|95.0|11.3|18.1||||||No risk subjects.||18.1|11.3|
91734866|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.2|9.1||||||No risk subjects.||9.1|4.2|
91734867|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.5|16.1||||||No risk subjects.||16.1|10.5|
91495690|NCT00299104|182863453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.0309||95.0|0.01|0.18||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.18|0.01|0.0309
91495691|NCT00299104|182863454|SUPERIORITY_OR_OTHER|||||||0.3752||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||0.3752
91495692|NCT00299104|182863454|SUPERIORITY_OR_OTHER|||||||0.0081||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.||||0.0081
91495693|NCT00299104|182863455|SUPERIORITY_OR_OTHER|||||||0.5939||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups.||||0.5939
91530140|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.29|2.15||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.15|-1.29|
91530141|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.6|2.53||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.53|-1.60|
91734868|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-25.3|15.4||||||At risk subjects||15.4|-25.3|
91734869|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-12.7|24.2||||||At risk subjects.||24.2|-12.7|
91734870|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group differences (B strain)|8.0|||||TWO_SIDED|95.0|-7.8|23.2||||||At risk subjects.||23.2|-7.8|
91734871|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|12.0|||||TWO_SIDED|95.0|8.2|15.3||||||No risk subjects.||15.3|8.2|
91734872|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.5|7.4||||||No risk subjects.||7.4|2.5|
91734873|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|15.3||||||No risk subjects.||15.3|9.2|
91734874|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
91734875|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
91734876|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|2.0|||||TWO_SIDED|95.0|-20.7|19.7||||||At risk subjects.||19.7|-20.7|
91734877|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.6|20.1||||||No risk subjects.||20.1|12.6|
91530142|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-3.03|0.81||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||0.81|-3.03|
91734878|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects||9.8|4.6|
91734879|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|11.9|18.3||||||No risk subjects.||18.3|11.9|
91734880|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
91734881|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
91734882|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|10.0|||||TWO_SIDED|95.0|-14.0|29.3||||||At risk subjects.||29.3|-14|
91734883|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-3.8|9.5||||||No risk subjects.||9.5|-3.8|
91734884|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|3.0|||||TWO_SIDED|95.0|-1.8|10.0||||||No risk subjects.||10|-1.8|
91734885|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|6.0|||||TWO_SIDED|95.0|1.5|12.5||||||No risk subjects.||12.5|1.5|
91734886|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-6.0|||||TWO_SIDED|95.0|-40.7|27.9||||||At risk subjects.||27.9|-40.7|
91734887|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.4|14.3||||||At risk subjects.||14.3|-38.4|
91734888|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|21.0|||||TWO_SIDED|95.0|-7.9|48.1||||||At risk subjects.||48.1|-7.9|
91734889|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|3.0|18.5||||||No risk subjects.||18.5|3|
91734890|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.2|15.6||||||No risk subjects.||15.6|2.2|
91734891|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|9.6||||||No risk subjects.||9.6|0|
91734892|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-41.7|35.0||||||At risk subjects.||35|-41.7|
91734893|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.6|23.4||||||At risk subjects.||23.4|-38.6|
91734894|NCT01346592|183363677|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-26.9|31.0||||||At risk subjects.||31|-26.9|
91734895|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.29|||||TWO_SIDED|95.0|1.91|2.76||||||No risk subjects.||2.76|1.91|
91734896|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.35|1.89||||||No risk subjects.||1.89|1.35|
91734897|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.92|||||TWO_SIDED|95.0|2.57|3.31||||||No risk subjects.||3.31|2.57|
91734898|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.53|||||TWO_SIDED|95.0|0.6|3.93||||||At risk subjects.||3.93|0.6|
91734899|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.02|||||TWO_SIDED|95.0|0.89|4.61||||||At risk subjects.||4.61|0.89|
91734900|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.5|||||TWO_SIDED|95.0|1.34|4.67||||||At risk subjects.||4.67|1.34|
91495694|NCT00299104|182863455|SUPERIORITY_OR_OTHER|||||||0.5478||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.5478
91495695|NCT00299104|182863455|SUPERIORITY_OR_OTHER|||||||0.3096||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.3096
91495696|NCT00299104|182863460|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
91530143|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-3.13|0.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||0.78|-3.13|
91530144|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|-3.36|0.71||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||0.71|-3.36|
91530145|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-2.69|1.0||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||1.00|-2.69|
91734901|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.33|||||TWO_SIDED|95.0|2.77|4.01||||||No risk subjects.||4.01|2.77|
91734902|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.07|||||TWO_SIDED|95.0|1.75|2.45||||||No risk subjects||2.45|1.75|
91734903|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.72|3.49||||||No risk subjects||3.49|2.72|
91734904|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.71|||||TWO_SIDED|95.0|0.65|4.5||||||At risk subjects.||4.5|0.65|
91734905|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.22|||||TWO_SIDED|95.0|1.38|7.51||||||At risk subjects.||7.51|1.38|
91734906|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.1|||||TWO_SIDED|95.0|1.1|3.98||||||At risk subjects.||3.98|1.1|
91734907|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|2.59|||||TWO_SIDED|95.0|2.1|3.21||||||No risk subjects.||3.21|2.1|
91734908|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.08|||||TWO_SIDED|95.0|1.71|2.52||||||No risk subjects.||2.52|1.71|
91734909|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|3.73|||||TWO_SIDED|95.0|3.22|4.33||||||No risk subjects.||4.33|3.22|
91734910|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
91734911|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.86|||||TWO_SIDED|95.0|0.94|8.66||||||At risk subjects.||8.66|0.94|
91734912|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
91734913|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|3.67|||||TWO_SIDED|95.0|2.97|4.54||||||No risk subjects.||4.54|2.97|
91734914|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.78|||||TWO_SIDED|95.0|2.29|3.37||||||No risk subjects.||3.37|2.29|
91734915|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|4.01|||||TWO_SIDED|95.0|3.46|4.65||||||No risk subjects.||4.65|3.46|
91734916|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
91734917|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|4.32|||||TWO_SIDED|95.0|1.43|13.0||||||At risk subjects.||13|1.43|
91734918|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.69|||||TWO_SIDED|95.0|1.67|8.15||||||At risk subjects.||8.15|1.67|
91530146|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-4.19|0.32||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||0.32|-4.19|
91530147|NCT03657264|182936609|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.62|2.04||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.04|-1.62|
91495697|NCT00299104|182863460|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
91495698|NCT00299104|182863470|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.||||<0.0001
91495699|NCT00299104|182863470|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
91495700|NCT00299104|182863476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.||||<0.0001
91495701|NCT00299104|182863480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
91530148|NCT03657264|182936610|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|2.58|6.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1 hour||6.66|2.58|
91530149|NCT03657264|182936610|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|9.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|7.14|11.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1.5 hours||11.66|7.14|
91495702|NCT00299104|182863480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
91495703|NCT03167411|182863499|EQUIVALENCE|The ratio of the least squares (LS) geometric means of Cmax when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|125.27|||||TWO_SIDED|90.0|104.45|150.24|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||150.24|104.45|
91530150|NCT03657264|182936610|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.55|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|7.92|13.17||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 2 hours||13.17|7.92|
91702408|NCT00772005|183299682|SUPERIORITY_OR_OTHER|||||||0.7522||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7522
91702409|NCT00772005|183299682|SUPERIORITY_OR_OTHER|||||||0.3183||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3183
91702410|NCT00772005|183299683|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
91702411|NCT00772005|183299683|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8910
91702412|NCT00772005|183299683|SUPERIORITY_OR_OTHER|||||||0.1795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1795
91702413|NCT00772005|183299684|SUPERIORITY_OR_OTHER|||||||0.6378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6378
91734919|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.35|||||TWO_SIDED|95.0|0.89|2.04||||||No risk subjects.||2.04|0.89|
91734920|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.59|||||TWO_SIDED|95.0|1.14|2.22||||||No risk subjects.||2.22|1.14|
91734921|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.68|||||TWO_SIDED|95.0|1.3|2.15||||||No risk subjects.||2.15|1.3|
91495704|NCT03167411|182863502|EQUIVALENCE|The ratio of the least squares (LS) geometric means of AUC0-inf when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|137.56|||||TWO_SIDED|90.0|122.28|154.75|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||154.75|122.28|
91495705|NCT00420927|182863509|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Chi-squared|P value is from Pearson's chi-square test.||||||0.023
91495706|NCT00420927|182863510|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Regression, Logistic|||||||0.082
91530151|NCT03657264|182936610|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.33|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|90.0|7.7|12.95||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 3 hours||12.95|7.70|
91495707|NCT00420927|182863511|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|||||||0.280
91530152|NCT03657264|182936610|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.65|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|8.05|13.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 4 hours||13.25|8.05|
91530153|NCT00924469|182936612|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.61||||0.0216||90.0|0.429|0.865||Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 12||0.865|0.429|0.0216
91530154|NCT00924469|182936613|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.43||||0.1423||90.0|0.956|2.145||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 24||2.145|0.956|0.1423
91530155|NCT00924469|182936613|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.82||||0.6639||90.0|0.386|1.746||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 24||1.746|0.386|0.6639
91530156|NCT00924469|182936614|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.32|||<|0.0001||90.0|0.239|0.418||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for androstenedione concentration at Week 12||0.418|0.239|<0.0001
91530157|NCT00924469|182936614|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.5061||90.0|0.828|1.554||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for androstenedione concentration at Week 24||1.554|0.828|0.5061
91734922|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.73|||||TWO_SIDED|95.0|0.29|10.0||||||At risk subjects.||10|0.29|
91495708|NCT00420927|182863511|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Regression, Logistic|||||||0.287
91495709|NCT00420927|182863512|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Regression, Logistic|||||||0.026
91495710|NCT00420927|182863512|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Logistic|||||||0.009
91495711|NCT00420927|182863513|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
91530158|NCT00924469|182936614|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.03|||<|0.0001||90.0|0.017|0.05||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 3 for DHEA concentration at Week 12||0.050|0.017|<0.0001
91530159|NCT00924469|182936614|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.79||||0.5767||90.0|0.398|1.581||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 4 for DHEA concentration at Week 24||1.581|0.398|0.5767
91734923|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.16|||||TWO_SIDED|95.0|0.33|4.01||||||At risk subjects.||4.01|0.33|
91734924|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.45|||||TWO_SIDED|95.0|0.53|3.94||||||At risk subjects.||3.94|0.53|
91734925|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.24|||||TWO_SIDED|95.0|1.48|3.39||||||No risk subjects||3.39|1.48|
91734926|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.76|||||TWO_SIDED|95.0|1.26|2.46||||||No risk subjects.||2.46|1.26|
91734927|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.59|||||TWO_SIDED|95.0|1.24|2.04||||||No risk subjects||2.04|1.24|
91495712|NCT00420927|182863513|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Regression, Logistic|||||||0.063
91495713|NCT00420927|182863514|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||Regression, Logistic|||||||0.395
91530160|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.14|||<|0.0001||90.0|0.097|0.207||Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 1 for serum testosterone concentration at Week 12||0.207|0.097|<0.0001
91530161|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.4364||90.0|0.571|1.225||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 2 for serum testosterone concentration at Week 24||1.225|0.571|0.4364
91734928|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.48|||||TWO_SIDED|95.0|0.34|18.0||||||At risk subjects.||18|0.34|
91734929|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.98|||||TWO_SIDED|95.0|0.49|7.92||||||At risk subjects.||7.92|0.49|
91734930|NCT01346592|183363678|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|0.71|||||TWO_SIDED|95.0|0.23|2.16||||||At risk subjects.||2.16|0.23|
91734931|NCT01346592|183363681|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|4.07|||||TWO_SIDED|95.0|3.34|4.95||||||GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \>1.0||4.95|3.34|
91734932|NCT01346592|183363681|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.95|||||TWO_SIDED|95.0|1.74|2.18||||||statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \>1.0||2.18|1.74|
91734933|NCT01346592|183363681|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|2.03|||||TWO_SIDED|95.0|1.73|2.39||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.39|1.73|
91734934|NCT01346592|183363681|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.82||||||95.0|3.14|4.64||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||4.64|3.14|
91734935|NCT01346592|183363681|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.15|2.68||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.68|2.15|
91495714|NCT00420927|182863514|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||Regression, Logistic|||||||0.640
91495715|NCT00420927|182863515|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Regression, Logistic|||||||0.159
91495716|NCT00420927|182863515|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Regression, Logistic|||||||0.217
91495717|NCT00420927|182863516|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
91495718|NCT00420927|182863516|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Regression, Logistic|||||||0.043
91495719|NCT00420927|182863517|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.004
91495720|NCT00420927|182863517|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.049
91734936|NCT01346592|183363681|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.95|||||TWO_SIDED|95.0|1.65|2.29||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.29|1.65|
91734937|NCT00402987|183363808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.0003||95.0|5.5|17.9|||generalized linear model|p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.||17.9|5.5|0.0003
91734938|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.212
91734939|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.056
91734940|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
91734941|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
91734942|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734943|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734944|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734945|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495721|NCT00420927|182863518|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|||||||0.240
91495722|NCT00420927|182863518|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||Regression, Logistic|||||||0.271
91530162|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.75||||0.1515||90.0|0.54|1.044||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 3 for serum DHT concentration at Week 12||1.044|0.540|0.1515
91530163|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.3965||90.0|0.589|1.188||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 4 for serum DHT concentration at Week 24||1.188|0.589|0.3965
91734946|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734947|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734948|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734949|NCT00402987|183363809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734950|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91734951|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734952|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
91734953|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
91734954|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.014
91734955|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
91495723|NCT00420927|182863519|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Regression, Logistic|||||||0.230
91495724|NCT00420927|182863519|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Regression, Logistic|||||||0.550
91495725|NCT00420927|182863520|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Regression, Logistic|||||||0.301
91495726|NCT00420927|182863520|SUPERIORITY_OR_OTHER|||||||0.188||95.0|||||Regression, Logistic|||||||0.188
91495727|NCT00420927|182863521|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Regression, Logistic|||||||0.314
91495728|NCT00420927|182863521|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||Regression, Logistic|||||||0.235
91495729|NCT00420927|182863522|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.030
91495730|NCT00420927|182863522|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.403
91495731|NCT00420927|182863523|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.036
91495732|NCT00420927|182863523|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.349
91734956|NCT00402987|183363810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.365
91734957|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
91734958|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
91734959|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
91734960|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
91734961|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734962|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734963|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734964|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495733|NCT00420927|182863524|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.037
91530164|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42||||0.0003||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 5 for serum Androsterone concentration at Week 12||0.615|0.290|0.0003
91495734|NCT00420927|182863524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||<0.001
91495735|NCT00420927|182863525|SUPERIORITY_OR_OTHER|||||||0.192||95.0|||||Regression, Logistic|||||||0.192
91495736|NCT00420927|182863525|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Regression, Logistic|||||||0.241
91495737|NCT00420927|182863526|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|||||||0.028
91495738|NCT00420927|182863526|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Logistic|||||||0.014
91495739|NCT00420927|182863527|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Regression, Logistic|||||||0.074
91495740|NCT00420927|182863527|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Regression, Logistic|||||||0.077
91495741|NCT01025752|182863530|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|0.07||||0.007|TWO_SIDED|95.0|-0.67|0.8||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.80) fell below the non-inferiority margin of 1.|post-treatment (12 weeks) time point||0.80|-0.67|0.007
91530165|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2494||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 6 for serum androsterone concentration at Week 24||1.625|0.916|0.2494
91530166|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.04|||<|0.0001||90.0|0.023|0.073||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 7 for serum DHEA concentration at Week 12||0.073|0.023|<0.0001
91734965|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734966|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734967|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734968|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734969|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.096
91734970|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.034
91734971|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
91734972|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
91530167|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.24||||0.5144||90.0|0.717|2.137||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 8 for serum DHEA concentration at Week 24||2.137|0.717|0.5144
91734973|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
91734974|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
91734975|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91734976|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734977|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734978|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734979|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734980|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734981|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
91530168|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.1|||<|0.0001||90.0|0.055|0.189||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12||0.189|0.055|<0.0001
91530169|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.55||||0.1329||90.0|0.286|1.06||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24||1.060|0.286|0.1329
91530170|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.01|||<|0.0001||90.0|0.008|0.028||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12||0.028|0.008|<0.0001
91734982|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.759||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.759
91734983|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
91734984|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
91734985|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.419||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.419
91734986|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.237
91734987|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.146
91734988|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.113
91734989|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analyaia at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
91734990|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
91734991|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.183
91734992|NCT00402987|183363811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
91734993|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734994|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734995|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734996|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734997|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734998|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91734999|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735000|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735001|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530171|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.2||||0.7061||90.0|0.53|2.73|||ANCOVA|||Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24||2.730|0.530|0.7061
91735002|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735003|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735004|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735005|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.017
91735006|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.011
91735007|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
91735008|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
91735009|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
91735010|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
91530172|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42|||<|0.0001||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12||0.615|0.290|<0.0001
91530173|NCT00924469|182936615|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2673||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24||1.625|0.916|0.2673
91530174|NCT00924469|182936616|SUPERIORITY_OR_OTHER||Relative risk|25.533|||<|0.0001||90.0|4.989|130.68|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for PSA response at Week 12||130.680|4.989|<0.0001
91530175|NCT00924469|182936616|SUPERIORITY_OR_OTHER||Relative risk|1.131||||0.2319||90.0|0.956|1.337|||Cochran-Mantel-Haenszel|||Statistical Analysis 2 for PSA response at Week 24||1.337|0.956|0.2319
91530176|NCT00924469|182936617|SUPERIORITY_OR_OTHER||Relative risk|2.744||||0.3427||90.0|1.018|5.015|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for CR at Week 24||5.015|1.018|0.3427
91735011|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
91735012|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
91735013|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.904||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.904
91735014|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.891||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.891
91735015|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.929
91735016|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.994
91735017|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.933
91735018|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.876
91735019|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.622
91735020|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
91530177|NCT00924469|182936620|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.17|||<|0.0001||90.0|0.098|0.289||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 12||0.289|0.098|<0.0001
91530178|NCT01651936|182936624|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.52||||0.308|TWO_SIDED|95.0|-1.54|0.5|||Constrained Longitudinal Data Analysis|||||0.50|-1.54|0.308
91530179|NCT01651936|182936625|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|-0.26||||0.91|TWO_SIDED|95.0|-23.52|23.01|||Cochran-Mantel-Haenszel|||||23.01|-23.52|0.91
91530180|NCT01651936|182936627|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|8.46||||0.468|TWO_SIDED|95.0|-10.4|27.32|||Cochran-Mantel-Haenszel|||||27.32|-10.40|0.468
91530181|NCT01651936|182936629|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.41||||0.038|TWO_SIDED|95.0|-0.79|-0.02|||Constrained Longitudinal Data Analysis|||||-0.02|-0.79|0.038
91530182|NCT03875911|182936677|EQUIVALENCE|ANOVA was used to analyze equivalence between arms||||||0.52|||||||ANOVA|||||||0.52
91530183|NCT03875911|182936678|EQUIVALENCE|Equivalence calculated using ANOVA||||||0.01|||||||ANOVA|||||||0.01
91530184|NCT03875911|182936679|EQUIVALENCE|Equivalence was assessed using ANOVA||||||0.25|||||||ANOVA|||||||0.25
91530185|NCT03875911|182936680|EQUIVALENCE|Equivalence determined by ANOVA||||||0.93|||||||ANOVA|||||||0.93
91530186|NCT03875911|182936681|EQUIVALENCE|Equivalence determined by ANOVA||||||0.83|||||||ANOVA|||||||0.83
91530187|NCT03875911|182936682|EQUIVALENCE|Equivalence was determined using ANOVA||||||0.54|||||||ANOVA|||||||0.54
91530188|NCT02293837|182936726|SUPERIORITY|||||||0.277||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52; Primary imputation method used for missing Week 52 mAUC.||||0.277
91530189|NCT02293837|182936727|SUPERIORITY|||||||0.499||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.499
91530190|NCT02293837|182936727|SUPERIORITY|||||||0.267||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.267
91530191|NCT02293837|182936727|SUPERIORITY|||||||0.226||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.226
91530192|NCT02293837|182936727|SUPERIORITY|||||||0.758||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.758
91530193|NCT02293837|182936727|SUPERIORITY|||||||0.341||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.341
91530194|NCT02293837|182936727|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
91530195|NCT02293837|182936727|SUPERIORITY|||||||0.689||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.689
91530196|NCT02293837|182936727|SUPERIORITY|||||||0.4||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.400
91530197|NCT02293837|182936727|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
91530198|NCT02293837|182936728|SUPERIORITY|||||||0.679||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.679
91530199|NCT02293837|182936728|SUPERIORITY|||||||0.373||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.373
91530200|NCT02293837|182936728|SUPERIORITY|||||||0.395||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.395
91530201|NCT02293837|182936729|SUPERIORITY|||||||0.176||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.176
91530202|NCT02293837|182936729|SUPERIORITY|||||||0.285||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.285
91530203|NCT02293837|182936729|SUPERIORITY|||||||0.435||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.435
91530204|NCT02293837|182936729|SUPERIORITY|||||||0.931||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.931
91530205|NCT02293837|182936729|SUPERIORITY|||||||0.28||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.280
91530206|NCT02293837|182936729|SUPERIORITY|||||||0.985||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.985
91735021|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.117
91735022|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.152||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.152
91735023|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
91735024|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
91735025|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
91735026|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.708
91735027|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.106
91735028|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.140
91735029|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.188
91495742|NCT01025752|182863530|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.23|||<|0.0001|TWO_SIDED|95.0|-0.94|0.49||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.49) fell below the non-inferiority margin of 1.|3 month post-baseline time point||0.49|-0.94|<0.0001
91530207|NCT02293837|182936730|SUPERIORITY|||||||0.762||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.762
91530208|NCT02293837|182936730|SUPERIORITY|||||||0.64||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.640
91735030|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.239
91735031|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.297
91735032|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.383
91735033|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.919
91735034|NCT00402987|183363812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735035|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
91735036|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.697||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.697
91735037|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.203||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.203
91735038|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
91735039|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735040|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735041|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735042|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735043|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735044|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735045|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530209|NCT02293837|182936730|SUPERIORITY|||||||0.145||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.145
91735046|NCT00402987|183363813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530210|NCT02293837|182936730|SUPERIORITY|||||||0.033||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.033
91735047|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735048|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
91735049|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
91735050|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
91530211|NCT02293837|182936730|SUPERIORITY|||||||0.591||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline avg insulin use per kg, and age.|ANCOVA|||Week 52||||0.591
91530212|NCT02293837|182936730|SUPERIORITY|||||||0.81||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.810
91530213|NCT02293837|182936730|SUPERIORITY|||||||0.178||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.178
91530214|NCT02293837|182936730|SUPERIORITY|||||||0.43||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.430
91530215|NCT02293837|182936730|SUPERIORITY|||||||0.149||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.149
91530216|NCT02293837|182936731|SUPERIORITY|||||||0.103||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.103
91530217|NCT02293837|182936731|SUPERIORITY|||||||0.452||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.452
91530218|NCT02293837|182936731|SUPERIORITY|||||||0.091||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.091
91530219|NCT02293837|182936732|SUPERIORITY|||||||0.154||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.154
91530220|NCT02293837|182936732|SUPERIORITY|||||||0.193||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.193
91530221|NCT02293837|182936732|SUPERIORITY|||||||0.397||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.397
91530222|NCT02293837|182936732|SUPERIORITY|||||||0.125||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.125
91530223|NCT02293837|182936732|SUPERIORITY|||||||0.705||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.705
91530224|NCT02293837|182936732|SUPERIORITY|||||||0.378||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.378
91530225|NCT02293837|182936732|SUPERIORITY|||||||0.035||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.035
91530226|NCT02293837|182936732|SUPERIORITY|||||||0.262||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.262
91530227|NCT02293837|182936732|SUPERIORITY|||||||0.338||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.338
91530228|NCT02293837|182936733|SUPERIORITY|||||||0.493||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.493
91530229|NCT02293837|182936733|SUPERIORITY|||||||0.659||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.659
91530230|NCT02293837|182936733|SUPERIORITY|||||||0.407||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.407
91530231|NCT02293837|182936734|SUPERIORITY|||||||0.634||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.634
91530232|NCT02293837|182936734|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
91495743|NCT01025752|182863530|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.08||||0.004|TWO_SIDED|95.0|-0.86|0.71||The non-inferiority margin is 1.|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.71) fell below the non-inferiority margin of 1.|6 month post- baseline time point.||0.71|-0.86|0.004
91735051|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
91735052|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.226
91735053|NCT00402987|183363814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
91735054|NCT00402987|183363815|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.01||95.0|1.3|5.5||Treatment as a factor|Regression, Logistic|||||5.5|1.3|0.010
91735055|NCT00402987|183363815|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.003||95.0|1.5|6.4||Treatment as a factor|Regression, Logistic|||||6.4|1.5|0.003
91735056|NCT00402987|183363815|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.634||95.0|0.6|2.2||Treatment as a factor|Regression, Logistic|||||2.2|0.6|0.634
91735057|NCT00402987|183363816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.63||||0.202||95.0|0.8|3.5||Treatment as a factor|Regression, Logistic|||||3.5|0.8|0.202
91735058|NCT00402987|183363816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.077||95.0|0.9|5.1||Treatment as a factor|Regression, Logistic|||||5.1|0.9|0.077
91735059|NCT00402987|183363816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.134||95.0|0.8|4.7||Treatment as a factor|Regression, Logistic|||||4.7|0.8|0.134
91735060|NCT00402987|183363816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.84||||0.671||95.0|0.4|1.9||Treatment as a factor|Regression, Logistic|||||1.9|0.4|0.671
91735061|NCT00402987|183363816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.484||95.0|0.3|1.7||Treatment as a factor|Regression, Logistic|||||1.7|0.3|0.484
91530233|NCT02293837|182936734|SUPERIORITY|||||||0.329||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.329
91735062|NCT00402987|183363816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||Treatment as a factor|Regression, Logistic|||||2.8|0.4|0.814
91495744|NCT01025752|182863531|OTHER||Mean Difference (Final Values)|-0.33||||0.12|TWO_SIDED|95.0|-0.74|0.09|||Mixed Models Analysis|||Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.09|-0.74|0.12
91530234|NCT02293837|182936734|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
91735063|NCT00402987|183363817|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
91735064|NCT00402987|183363817|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
91735065|NCT00402987|183363817|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
91735066|NCT00402987|183363818|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.||||<0.05
91735067|NCT00402987|183363818|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours||||<0.05
91735068|NCT00402987|183363819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
91735069|NCT00402987|183363819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
91735070|NCT00402987|183363820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
91735071|NCT00402987|183363820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
91735072|NCT00402987|183363820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889||95.0||||Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.889
91735073|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
91735074|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
91735075|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
91735076|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.411
91735077|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.930
91735078|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.438
91735079|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
91735080|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.013
91735081|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
91735082|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.748
91735083|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.958
91735084|NCT00402987|183363821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.747
91735085|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.999
91735086|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
91735087|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.076
91735088|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
91735089|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735090|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735091|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735092|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735093|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735094|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735095|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735096|NCT00402987|183363822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91495745|NCT01025752|182863531|OTHER||Mean Difference (Final Values)|-0.34||||0.2|TWO_SIDED|95.0|-0.87|0.18|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.18|-0.87|0.20
91495746|NCT01025752|182863531|OTHER||Mean Difference (Final Values)|-0.02||||0.93|TWO_SIDED|95.0|-0.57|0.52|||Mixed Models Analysis|||6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.52|-0.57|0.93
91530235|NCT02293837|182936734|SUPERIORITY|||||||0.847||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.847
91530236|NCT02293837|182936734|SUPERIORITY|||||||0.858||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||0.858
91735097|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
91735098|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
91735099|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.043
91735100|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.032
91735101|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
91735102|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.066
91735103|NCT00402987|183363823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.482
91735104|NCT00402987|183363824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||<|0.001||95.0|0.8|1.9||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.8|<0.001
91735105|NCT00402987|183363824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.002||95.0|0.4|1.5||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.4|0.002
91735106|NCT00402987|183363824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.186||95.0|-1.0|0.2||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.186
91495747|NCT01025752|182863532|OTHER||Mean Difference (Final Values)|-0.5||||0.58|TWO_SIDED|95.0|-2.29|1.29|||Mixed Models Analysis|||post-treatment (12 weeks) time point||1.29|-2.29|0.58
91495748|NCT01025752|182863532|OTHER||Mean Difference (Final Values)|-1.53||||0.12|TWO_SIDED|95.0|-3.46|0.41|||Mixed Models Analysis|||3 months post-baseline time point||0.41|-3.46|0.12
91495749|NCT01025752|182863532|OTHER||Mean Difference (Final Values)|-0.61||||0.51|TWO_SIDED|95.0|-2.42|1.2|||Mixed Models Analysis|||6 months post-baseline time point||1.20|-2.42|0.51
91495750|NCT01025752|182863533|OTHER||Mean Difference (Final Values)|0.29||||0.83|TWO_SIDED|95.0|-2.3|2.87|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||2.87|-2.30|0.83
91495751|NCT01025752|182863533|OTHER||Mean Difference (Final Values)|1.15||||0.42|TWO_SIDED|95.0|-1.68|3.98|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||3.98|-1.68|0.42
91495752|NCT01025752|182863533|OTHER||Mean Difference (Final Values)|-0.58||||0.68|TWO_SIDED|95.0|-3.4|2.24|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.24|-3.40|0.68
91495753|NCT01025752|182863534|OTHER||Mean Difference (Final Values)|1.25||||0.4|TWO_SIDED|95.0|-1.66|4.16|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||4.16|-1.66|0.40
91495754|NCT01025752|182863534|OTHER||Mean Difference (Final Values)|0.38||||0.81|TWO_SIDED|95.0|-2.82|3.58|||Mixed Models Analysis|||3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)||3.58|-2.82|0.81
91530237|NCT02293837|182936735|SUPERIORITY|||||||0.296||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.296
91530238|NCT02293837|182936735|SUPERIORITY|||||||0.145||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.145
91530239|NCT02293837|182936735|SUPERIORITY|||||||0.027||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.027
91530240|NCT02293837|182936736|SUPERIORITY|||||||0.547||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.547
91735107|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.961
91530241|NCT02293837|182936736|SUPERIORITY|||||||0.551||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.551
91530242|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.27||||0.087|TWO_SIDED|95.0|-0.58|0.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.||||0.04|-0.58|0.087
91530243|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.84|||<|0.001|TWO_SIDED|95.0|-1.15|-0.52||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.52|-1.15|<0.001
91530244|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.014|TWO_SIDED|95.0|-0.69|-0.08||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.08|-0.69|0.014
91530245|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.68|||<|0.001|TWO_SIDED|95.0|-0.99|-0.37||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.99|<0.001
91530246|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.93||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.93|-1.55|<0.001
91530247|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.97|||<|0.001|TWO_SIDED|95.0|-1.28|-0.66||Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.66|-1.28|<0.001
91530248|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.08|||<|0.001|TWO_SIDED|95.0|-1.39|-0.78||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.78|-1.39|<0.001
91530249|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7|||<|0.001|TWO_SIDED|95.0|-1.01|-0.39||Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.39|-1.01|<0.001
91530250|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.011|TWO_SIDED|95.0|-0.71|-0.09||Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.71|0.011
91530251|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.36||||0.008|TWO_SIDED|95.0|-0.62|-0.09||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.62|0.008
91530252|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.87|||<|0.001|TWO_SIDED|95.0|-1.13|-0.6||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.60|-1.13|<0.001
91530253|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.36||||0.007|TWO_SIDED|95.0|-0.63|-0.1||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.10|-0.63|0.007
91530254|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.35|-0.88|<0.001
91702414|NCT00772005|183299684|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8679
91495755|NCT01025752|182863534|OTHER||Mean Difference (Final Values)|2.43||||0.16|TWO_SIDED|95.0|-0.96|5.82|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||5.82|-0.96|0.16
91735108|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.985||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.985
91735109|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.975||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.975
91735110|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.532
91735111|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.690
91735112|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.820
91735113|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
91735114|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
91735115|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.693
91735116|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.039
91735117|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.154
91495756|NCT01025752|182863535|OTHER||Mean Difference (Final Values)|0.24||||0.85|TWO_SIDED|95.0|-2.32|2.8|||Mixed Models Analysis|||post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)||2.80|-2.32|0.85
91735118|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.521
91735119|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
91735120|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
91735121|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
91735122|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735123|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
91735124|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.249
91735125|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735126|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
91495757|NCT01025752|182863535|OTHER||Mean Difference (Final Values)|-1.27||||0.4|TWO_SIDED|95.0|-4.27|1.73|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.73|-4.27|0.40
91495758|NCT01025752|182863535|OTHER||Mean Difference (Final Values)|-0.74||||0.68|TWO_SIDED|95.0|-4.3|2.83|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.83|-4.30|0.68
91495759|NCT01025752|182863536|OTHER||Mean Difference (Final Values)|-0.94||||0.17|TWO_SIDED|95.0|-2.28|0.4|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.40|-2.28|0.17
91495760|NCT01025752|182863536|OTHER||Mean Difference (Final Values)|-0.12||||0.86|TWO_SIDED|95.0|-1.39|1.16|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.16|-1.39|0.86
91495761|NCT01025752|182863536|OTHER||Mean Difference (Final Values)|0.37||||0.64|TWO_SIDED|95.0|-1.22|1.97|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.97|-1.22|0.64
91495762|NCT00843024|182863556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.003|TWO_SIDED|95.0|0.09|0.3||Adjusted for multiplicity according to the fixed sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 10 mg/Naproxen 60 mg minus placebo|||0.30|0.09|0.003
91495763|NCT00843024|182863556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.003|TWO_SIDED|95.0|0.07|0.26||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 30 mg/Naproxen180 mg minus placebo|||0.26|0.07|0.003
91735127|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.205
91735128|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735129|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
91735130|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.186||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.186
91735131|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735132|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735133|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.179||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.179
91735134|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735135|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735136|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
91735137|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495764|NCT00843024|182863556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.003|TWO_SIDED|95.0|0.05|0.22||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 85 mg/Naproxen 500 mg minus placebo|||0.22|0.05|0.003
91735138|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735139|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.393||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.393
91735140|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735141|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735142|NCT00402987|183363825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.512
91735143|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91513362|NCT01381172|182898390|OTHER|The primary analysis employed a Bayesian repeated measures linear model to estimate group differences in mean pVO2 at 24 weeks from baseline, with 30% borrowing of information (70% down-weighting) from the corresponding treatment group difference observed in the FIX-5 study subgroup. The Bayesian posterior probability would need to be \> 0.975 to be considered a positive result with statistical significance.||||||0.975||||||The posterior probability (Pr) that the mean difference in pVO2 (Δ3) between device and control groups is greater than zero must exceed 0.975 to meet the primary effectiveness endpoint.|Bayesian posterior probability|||The FIX-HF-5C Study was a study designed to confirm the preliminary evidence reported in the FIX-HF-5 subgroup analysis demonstrating improvement in subjects with LVEF 25-45% and NYHA class III-IV. A Bayesian statistical approach was employed to leverage the data available, particularly the pVO2 results, from the FIX-HF-5 subgroup.||||0.975
91735144|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495765|NCT04600921|182863622|SUPERIORITY|The parameters required to calculate sample size were the expected rate of VT/VF episodes/year in the placebo group, the minimal VT/VF rate ratio to be detected in the ertugliflozin group compared with the placebo group, the average follow-up of treatment duration, the negative binomial dispersion parameter, type 1 error probability, and the desired power.|Rate Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.04|0.61||The yearly rate ratio was adjusted for baseline number of sVT/VF episodes.|Negative binomial regression model|A prespecified sensitivity analysis was done to mitigate the effect of outliers by using the robust estimation approaches for negative binomial model.|Ertugliflozin is the numerator and the placebo is the denominator.|We compared the rate of sVT/VF episodes between experimental arms after 52 weeks.The initial sample calculation was based on the mathematical formula provided by Zhu and Lakkis for comparing event rates of two negative binomial distributiuons. To detect a 30% reduction in VT/VF episode rates in the ertugliflozin group compared to placebo group, with 80% power and an alpha level of 0.05, accounting for 5% drop out in each group, a total sample size of 402 was estimated to be required.||0.61|0.04|<0.001
91495766|NCT04600921|182863623|SUPERIORITY||Rate Ratio|0.34|||||TWO_SIDED|95.0|0.12|0.97||||||The number of incident nsVT episodes were analyzed using a beta binomial model.||0.97|0.12|
91495767|NCT04600921|182863624|SUPERIORITY||Rate Ratio|0.47|||||TWO_SIDED|95.0|0.13|1.81||||||The number of appropriate ICD therapies were analyzed by using beta binomial model.||1.81|0.13|
91495768|NCT04600921|182863625|SUPERIORITY||Difference in mean change|0.17|||>|0.05|TWO_SIDED|95.0|-0.35|0.69|||Regression, Linear|||The change in NTproBNP levels was analyzed by using a multiple linear regression model.||0.69|-0.35|>0.05
91495769|NCT04600921|182863626|SUPERIORITY||Mean Difference (Final Values)|0.72|||||TWO_SIDED|95.0|-1.69|3.13||||||The change in HbA1c levels from baseline to week 52 was analyzed by multiple linear regression model.||3.13|-1.69|
91530255|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.25|||<|0.001|TWO_SIDED|95.0|-1.52|-0.99||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.99|-1.52|<0.001
91530256|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9|||<|0.001|TWO_SIDED|95.0|-1.16|-0.63||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.63|-1.16|<0.001
91530257|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.0|||<|0.001|TWO_SIDED|95.0|-1.26|-0.74||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.74|-1.26|<0.001
91735145|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.026
91735146|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.463
91495770|NCT04600921|182863627|SUPERIORITY||Rate Ratio|0.6|||||TWO_SIDED|95.0|0.2|1.7||||||||1.7|0.2|
91495771|NCT05425745|182863642|SUPERIORITY||Least Squares (LS) Means|-36.31|STANDARD_ERROR_OF_MEAN|3.019|<|0.0001|TWO_SIDED|95.0|-42.22|-30.39|||ANCOVA|||||-30.39|-42.22|<.0001
91495772|NCT05425745|182863643|SUPERIORITY||Least Squares (LS) Means|-37.78|STANDARD_ERROR_OF_MEAN|3.572|<|0.0001|TWO_SIDED|95.0|-44.79|-30.78|||ANCOVA|||||-30.78|-44.79|<.0001
91530258|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.64|||<|0.001|TWO_SIDED|95.0|-0.9|-0.37||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.90|<0.001
91530259|NCT01076088|182936737|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.12||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.12|-0.65|0.004
91530260|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-18.52||||0.017|TWO_SIDED|95.0|-33.75|-3.29||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-3.29|-33.75|0.017
91530261|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-61.34|||<|0.001|TWO_SIDED|95.0|-76.61|-46.07||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-46.07|-76.61|<0.001
91735147|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.131
91735148|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.053
91495773|NCT05425745|182863644|SUPERIORITY||Least Squares (LS) Means|-41.45|STANDARD_ERROR_OF_MEAN|4.938|<|0.0001|TWO_SIDED|95.0|-51.14|-31.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-31.76|-51.14|<.0001
91735149|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495774|NCT05425745|182863645|SUPERIORITY||Least Squares (LS) Means|-24.39|STANDARD_ERROR_OF_MEAN|2.136|<|0.0001|TWO_SIDED|95.0|-28.58|-20.2||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.20|-28.58|<.0001
91495775|NCT05425745|182863646|SUPERIORITY||Least Squares (LS) Means|-24.32|STANDARD_ERROR_OF_MEAN|2.583|<|0.0001|TWO_SIDED|95.0|-29.38|-19.25||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.25|-29.38|<.0001
91495776|NCT05425745|182863647|SUPERIORITY||Least Squares (LS) Means|-25.77|STANDARD_ERROR_OF_MEAN|3.114|<|0.0001|TWO_SIDED|95.0|-31.88|-19.67||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.67|-31.88|<.0001
91495777|NCT05425745|182863648|SUPERIORITY||Least Squares (LS) Means|-34.45|STANDARD_ERROR_OF_MEAN|2.661|<|0.0001|TWO_SIDED|95.0|-39.67|-29.24||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-29.24|-39.67|<.0001
91495778|NCT05425745|182863649|SUPERIORITY||Least Squares (LS) Means|-33.0|STANDARD_ERROR_OF_MEAN|3.241|<|0.0001|TWO_SIDED|95.0|-39.36|-26.65||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.65|-39.36|<.0001
91495779|NCT05425745|182863650|SUPERIORITY||Least Squares (LS) Means|-37.48|STANDARD_ERROR_OF_MEAN|4.535|<|0.0001|TWO_SIDED|95.0|-46.38|-28.58||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||-28.58|-46.38|<.0001
91495780|NCT05425745|182863651|SUPERIORITY||Least Squares (LS) Means|138.66|STANDARD_ERROR_OF_MEAN|6.244|<|0.0001|TWO_SIDED|95.0|126.42|150.9||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||150.90|126.42|<.0001
91495781|NCT05425745|182863652|SUPERIORITY||Least Squares (LS) Means|131.2|STANDARD_ERROR_OF_MEAN|6.595|<|0.0001|TWO_SIDED|95.0|118.27|144.13||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||144.13|118.27|<.0001
91495782|NCT05425745|182863653|SUPERIORITY||Least Squares (LS) Means|121.39|STANDARD_ERROR_OF_MEAN|7.333|<|0.0001|TWO_SIDED|95.0|107.02|135.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||135.76|107.02|<.0001
91495783|NCT05425745|182863654|SUPERIORITY||Least Squares (LS) Means|-45.94|STANDARD_ERROR_OF_MEAN|10.14|<|0.0001|TWO_SIDED|95.0|-65.88|-26.0||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.00|-65.88|<.0001
91495784|NCT05425745|182863655|SUPERIORITY||Least Squares (LS) Means|-54.3|STANDARD_ERROR_OF_MEAN|38.924||0.1648|TWO_SIDED|95.0|-131.13|22.53||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||22.53|-131.13|0.1648
91495785|NCT02700815|182863662|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.277||0.0303|TWO_SIDED|95.0|-1.15|-0.06|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.06|-1.15|0.0303
91495786|NCT02700815|182863662|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.197||0.2886|TWO_SIDED|95.0|-0.18|0.6|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.60|-0.18|0.2886
91495787|NCT02700815|182863662|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.197||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.33|-1.10|0.0003
91530262|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-31.38|||<|0.001|TWO_SIDED|95.0|-46.49|-16.28||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-16.28|-46.49|<0.001
91530263|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-48.94|||<|0.001|TWO_SIDED|95.0|-64.21|-33.67||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-33.67|-64.21|<0.001
91530264|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-87.57|||<|0.001|TWO_SIDED|95.0|-102.87|-72.27||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-72.27|-102.87|<0.001
91530265|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-69.05|||<|0.001|TWO_SIDED|95.0|-84.41|-53.7||Pairwise comparison, metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-53.70|-84.41|<0.001
91735150|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735151|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
91735152|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.484
91735153|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
91735154|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
91735155|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735156|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735157|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
91735158|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
91735159|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.252
91495788|NCT02700815|182863663|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.221||0.0956|TWO_SIDED|95.0|-0.8|0.07|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between placebo and combination therapy diclofenac + capsaicin||0.07|-0.80|0.0956
91735160|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.136
91735161|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735162|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735163|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
91735164|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.653
91735165|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.287
91735166|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.191
91735167|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735168|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735169|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
91735170|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
91735171|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.326
91735172|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.256
91495789|NCT02700815|182863663|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.157||0.0564|TWO_SIDED|95.0|-0.01|0.61|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin||0.61|-0.01|0.0564
91495790|NCT02700815|182863663|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.157||0.0004|TWO_SIDED|95.0|-0.87|-0.25|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.25|-0.87|0.0004
91495791|NCT02700815|182863664|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.238||0.0347|TWO_SIDED|95.0|-0.97|-0.04|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between placebo and combination therapy diclofenac + capsaicin||-0.04|-0.97|0.0347
91495792|NCT02700815|182863664|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.169||0.0622|TWO_SIDED|95.0|-0.02|0.65|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin||0.65|-0.02|0.0622
91495793|NCT02700815|182863664|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.01|-0.35|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.35|-1.01|<0.0001
91495794|NCT02700815|182863665|SUPERIORITY||Odds Ratio (OR)|1.882||||0.0202|TWO_SIDED|95.0|1.1|3.21|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.21|1.10|0.0202
91495795|NCT02700815|182863665|SUPERIORITY||Odds Ratio (OR)|0.732||||0.1206|TWO_SIDED|95.0|0.49|1.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.09|0.49|0.1206
91495796|NCT02700815|182863665|SUPERIORITY||Odds Ratio (OR)|1.629||||0.0122|TWO_SIDED|95.0|1.11|2.39|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||2.39|1.11|0.0122
91735173|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495797|NCT02700815|182863666|SUPERIORITY||Odds Ratio (OR)|1.729||||0.0643|TWO_SIDED|95.0|0.97|3.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.09|0.97|0.0643
91530266|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-75.17|||<|0.001|TWO_SIDED|95.0|-90.47|-59.87||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-59.87|-90.47|<0.001
91735174|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91530267|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-43.79|||<|0.001|TWO_SIDED|95.0|-58.99|-28.58||Pairwise comparison, metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-28.58|-58.99|<0.001
91735175|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.016
91735176|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.808
91735177|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.394
91735178|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.343
91735179|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
91735180|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
91735181|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.023
91735182|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.892
91735183|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.952
91735184|NCT00402987|183363826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.948
91735185|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
91735186|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.094
91735187|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.114||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.114
91735188|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
91735189|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530268|NCT01076088|182936738|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-26.23|||<|0.001|TWO_SIDED|95.0|-41.62|-10.84||Pairwise comparison, sitagliptin 100 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-10.84|-41.62|<0.001
91530269|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.11||||0.069|TWO_SIDED|95.0|-16.86|0.64||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||0.64|-16.86|0.069
91530270|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-25.88|||<|0.001|TWO_SIDED|95.0|-34.72|-17.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-17.04|-34.72|<0.001
91735190|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735191|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735192|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735193|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735194|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735195|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735196|NCT00402987|183363827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735197|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735198|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
91735199|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
91735200|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
91735201|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.033
91495798|NCT02700815|182863666|SUPERIORITY||Odds Ratio (OR)|0.833||||0.3479|TWO_SIDED|95.0|0.57|1.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.22|0.57|0.3479
91495799|NCT02700815|182863666|SUPERIORITY||Odds Ratio (OR)|2.125||||0.0004|TWO_SIDED|95.0|1.4|3.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.22|1.40|0.0004
91495800|NCT02700815|182863667|SUPERIORITY||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.313||0.0008|TWO_SIDED|95.0|-1.67|-0.44|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.44|-1.67|0.0008
91735202|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.036
91530271|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.72||||0.198|TWO_SIDED|95.0|-14.44|3.0||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||3.00|-14.44|0.198
91735203|NCT00402987|183363828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.500
91735204|NCT00402987|183363829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|||<|0.001||95.0|8.5|23.8||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.8|8.5|<0.001
91735205|NCT00402987|183363829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.009||95.0|2.6|17.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||17.9|2.6|0.009
91735206|NCT00402987|183363829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9||||0.127||95.0|-13.5|1.7||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.7|-13.5|0.127
91735207|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.480
91735208|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.780
91735209|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.667
91495801|NCT02700815|182863667|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.223||0.3726|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.64|-0.24|0.3726
91735210|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.153
91735211|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.479
91735212|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.469
91735213|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.062
91735214|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.284
91735215|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.421
91735216|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
91495802|NCT02700815|182863667|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.56|-0.68|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.68|-1.56|<0.0001
91495803|NCT02700815|182863668|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.844||0.881|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.53|-1.78|0.8810
91735217|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
91735218|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.354
91735219|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
91735220|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
91735221|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.262
91735222|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735223|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.044
91735224|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.194
91735225|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495804|NCT02700815|182863668|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.601||0.6094|TWO_SIDED|95.0|-0.87|1.49|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.49|-0.87|0.6094
91735226|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
91735227|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.148
91735228|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735229|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
91735230|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.127||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.127
91735231|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735232|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735233|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.122
91735234|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530272|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-17.53|||<|0.001|TWO_SIDED|95.0|-26.33|-8.72||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-8.72|-26.33|<0.001
91530273|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-35.81|||<|0.001|TWO_SIDED|95.0|-44.56|-27.06||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-27.06|-44.56|<0.001
91495805|NCT02700815|182863668|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.602||0.2047|TWO_SIDED|95.0|-0.42|1.95|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.95|-0.42|0.2047
91735235|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735236|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.164
91735237|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735238|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735239|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
91495806|NCT02700815|182863669|SUPERIORITY||Mean Difference (Net)|1.65|STANDARD_ERROR_OF_MEAN|1.339||0.2193|TWO_SIDED|95.0|-0.98|4.27|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||4.27|-0.98|0.2193
91495807|NCT02700815|182863669|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.949||0.7672|TWO_SIDED|95.0|-1.58|2.15|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||2.15|-1.58|0.7672
91495808|NCT02700815|182863669|SUPERIORITY||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.0339|TWO_SIDED|95.0|0.15|3.88|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||3.88|0.15|0.0339
91495809|NCT02144233|182863686|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
91495810|NCT02785354|182863712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.51|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).||0.66|0.51|<0.0001
91495811|NCT02785354|182863712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0006|TWO_SIDED|95.0|0.75|0.92|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.92|0.75|0.0006
91530274|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.7|||<|0.001|TWO_SIDED|95.0|-36.4|-19.0||Pairwise comparison, metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-19.00|-36.40|<0.001
91735240|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735241|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735242|NCT00402987|183363830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.336
91735243|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530275|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.45|||<|0.001|TWO_SIDED|95.0|-36.18|-18.73||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-18.73|-36.18|<0.001
91530276|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-21.73|||<|0.001|TWO_SIDED|95.0|-30.42|-13.04||Pairwise comparison, metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-13.04|-30.42|<0.001
91530277|NCT01076088|182936739|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.93||||0.027|TWO_SIDED|95.0|-18.72|-1.14||Pairwise comparison, sitagliptin 100 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-1.14|-18.72|0.027
91530278|NCT05515679|182936748|SUPERIORITY||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.48|<|0.01|TWO_SIDED|95.0|0.51|0.94|||t-test, 2 sided|||Using a paired sample t-test (two tailed), we wished to examine whether there was an increase in Constructive Engagement and Pleasure and a reduction in Passive Engagement, Distracted Engagement, and Non-Engagement, from baseline to treatment. With an anticipated PWD sample of 24, and using means and standard deviations from the PI's previous studies, we calculated a power of 90% to detect effects (alpha = .05; one-tailed test). (3) PWD and staff report high satisfaction wi||.94|.51|<0.01
91530279|NCT05515679|182936749|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|0.6||0.017|TWO_SIDED|95.0|-0.59|-0.07|||t-test, 2 sided|||||-0.07|-0.59|.017
91530280|NCT05515679|182936750|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.41||0.008|TWO_SIDED|95.0|-0.43|-0.07|||t-test, 2 sided|||||-0.07|-0.43|.008
91530281|NCT05515679|182936751|SUPERIORITY||Median Difference (Final Values)|-0.15|STANDARD_DEVIATION|0.34||0.053|TWO_SIDED|95.0|-0.3|0.0|||t-test, 2 sided|||||-.00|-.30|0.053
91530282|NCT05515679|182936752|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.28|<|0.01|TWO_SIDED|95.0|0.54|0.79|||t-test, 2 sided|||||.79|.54|<.01
91530283|NCT05515679|182936753|SUPERIORITY||Mean Difference (Final Values)|4.11|STANDARD_DEVIATION|3.35|<|0.001|TWO_SIDED|95.0|2.62|5.6|||t-test, 2 sided|||||5.60|2.62|<.001
91530284|NCT05515679|182936754|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-1.55|-0.58|||t-test, 2 sided|||||-0.58|-1.55|<.001
91735244|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735245|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
91735246|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.518||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.518
91530285|NCT05515679|182936755|SUPERIORITY||Median Difference (Final Values)|6.02|STANDARD_DEVIATION|11.4||0.022|TWO_SIDED|95.0|0.97|11.1|||t-test, 2 sided|||||11.1|0.97|.022
91735247|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.038
91530286|NCT05515679|182936756|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_DEVIATION|9.5||0.551|TWO_SIDED|95.0|-2.9|5.44|||t-test, 2 sided|||||5.44|-2.90|.551
91530287|NCT05515679|182936757|SUPERIORITY||Mean Difference (Final Values)|27.43|STANDARD_DEVIATION|0.11|<|0.001|TWO_SIDED|95.0|17.7|37.2|||t-test, 2 sided|||||37.2|17.7|<.001
91735248|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.019
91735249|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91530288|NCT01448044|182936762|SUPERIORITY_OR_OTHER||difference in percentages|38.85|||<|0.0001|TWO_SIDED|95.0|21.703|55.997||The pvalue was based on the CochranMantelHaenszel (CMH) test, stratified by IL28B host genotype, geography, and baseline cirrhosis status.|Cochran-Mantel-Haenszel|||||55.997|21.703|<0.0001
91530289|NCT01952301|182936767|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91530290|NCT02216422|182936768|SUPERIORITY_OR_OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|90.4|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|90.4|
91530291|NCT04033991|182936801|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530292|NCT04033991|182936801|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530293|NCT04033991|182936802|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530294|NCT04033991|182936802|OTHER|||||||0.0068|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0068
91530295|NCT04033991|182936804|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530296|NCT04033991|182936804|OTHER|||||||0.0004|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0004
91530297|NCT04033991|182936805|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91495812|NCT02785354|182863713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.66|0.46|<0.0001
91495813|NCT02785354|182863713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.79|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.79|0.58|<0.0001
91530298|NCT04033991|182936805|OTHER|||||||0.0014|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0014
91530299|NCT04033991|182936810|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530300|NCT04033991|182936810|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530301|NCT04033991|182936811|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
91530302|NCT04033991|182936811|OTHER|||||||0.0094|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0094
91530303|NCT00577720|182936820|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.437|||||TWO_SIDED|90.0|1.091|1.964||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.964|1.091|
91530304|NCT00577720|182936820|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.507|||||TWO_SIDED|90.0|1.139|2.066||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.066|1.139|
91530305|NCT00577720|182936820|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.535|||||TWO_SIDED|90.0|1.177|2.086||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.086|1.177|
91530306|NCT00577720|182936820|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.068|||||TWO_SIDED|90.0|0.867|1.321||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.321|0.867|
91530307|NCT00577720|182936820|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.018|||||TWO_SIDED|90.0|0.824|1.267||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.267|0.824|
91530308|NCT00577720|182936821|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.208|||||TWO_SIDED|90.0|0.749|2.099||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.099|0.749|
91735250|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495814|NCT02785354|182863714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0007|TWO_SIDED|95.0|0.63|0.88|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.88|0.63|0.0007
91495815|NCT02785354|182863714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8341|TWO_SIDED|95.0|0.85|1.14|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.14|0.85|0.8341
91495816|NCT02785354|182863715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0147|TWO_SIDED|95.0|0.65|0.95|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.95|0.65|0.0147
91495817|NCT02785354|182863715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0501|TWO_SIDED|95.0|0.71|1.0|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.00|0.71|0.0501
91735251|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
91735252|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.552
91735253|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.050
91735254|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.027
91495818|NCT02785354|182863716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.67|0.82|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.82|0.67|<0.0001
91530309|NCT00577720|182936821|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.132|||||TWO_SIDED|90.0|0.665|2.003||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.003|0.665|
91530310|NCT00577720|182936821|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.407|||||TWO_SIDED|90.0|0.913|2.404||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.404|0.913|
91530311|NCT00577720|182936821|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.165|||||TWO_SIDED|90.0|0.797|1.752||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.752|0.797|
91735255|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495819|NCT02785354|182863716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.71|0.84|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.84|0.71|<0.0001
91530312|NCT00577720|182936821|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.243|||||TWO_SIDED|90.0|0.828|1.99||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.990|0.828|
91735256|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735257|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.071
91735258|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
91495820|NCT02785354|182863717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.66|0.76|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.76|0.66|<0.0001
91530313|NCT00577720|182936822|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|0.947|||||TWO_SIDED|90.0|0.316|2.993||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.993|0.316|
91530314|NCT00577720|182936822|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.82|||||TWO_SIDED|90.0|0.929|5.429||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||5.429|0.929|
91495821|NCT02785354|182863717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001|TWO_SIDED|95.0|0.79|0.89|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.89|0.79|<0.0001
91495822|NCT00875212|182863719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.001||95.0|||||ANOVA|repeated measure anova|The median value of each parameter (pH baseline, minimal pH) was obtained and these values were compared between each group|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The null hyphothesis was no difference between pH values of the groups. The statistical analysis was by repeated measurements ANOVA.||||0.001
91495823|NCT00875212|182863719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.1||0.001||95.0|||||ANOVA|repeated-measurements ANOVA||The comparison was based on mean and median values of plaque pH in different moments of cariogenic challenge. The null hypothesis was that no diference between the groups wil be found. The test hypothesis was that the experimental dentifrice of CaGP-F would provide a better control of plaque pH after 14 days of use.||||0.001
91530315|NCT00577720|182936822|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.58|||||TWO_SIDED|90.0|0.801|4.718||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.718|0.801|
91530316|NCT00577720|182936822|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.668|||||TWO_SIDED|90.0|0.856|4.668||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.668|0.856|
91495824|NCT00875212|182863720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.01||95.0|||||ANOVA|repeated measurements ANOVA|The difference of pH values between groups was above 1.0 unit.|The groups were compared by repeated measurements anova. There was no power calculation, but a pilot study to check the minimal number necessary of subjects in order to find a signifcant difference between interventions.||||0.01
91530317|NCT00577720|182936822|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mgDRBB)|0.868|||||TWO_SIDED|90.0|0.504|1.488||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.488|0.504|
91495825|NCT00848081|182863721|SUPERIORITY_OR_OTHER|||||||0.403||||||1-sided test|Fisher Exact|||The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.||||0.403
91495826|NCT00848081|182863723|SUPERIORITY_OR_OTHER|||||||0.13||||||p-value is on change from baseline|ANCOVA|||The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.||||0.130
91702415|NCT00772005|183299684|SUPERIORITY_OR_OTHER|||||||0.5489||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5489
91702416|NCT00772005|183299685|SUPERIORITY_OR_OTHER|||||||0.9337||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9337
91702417|NCT00772005|183299685|SUPERIORITY_OR_OTHER|||||||0.9428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9428
91702418|NCT00772005|183299685|SUPERIORITY_OR_OTHER|||||||0.5895||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5895
91702419|NCT00772005|183299686|SUPERIORITY_OR_OTHER|||||||0.8695||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8695
91702420|NCT00772005|183299686|SUPERIORITY_OR_OTHER|||||||0.6637||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6637
91702421|NCT00772005|183299686|SUPERIORITY_OR_OTHER|||||||0.3152||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3152
91495827|NCT00848081|182863724|SUPERIORITY_OR_OTHER|||||||0.258||||||p-value is on change from baseline|ANOVA|The p-value is from Type III sums of squares ANOVA on rank-transformed data.||||||0.258
91495828|NCT00848081|182863725|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.||||||0.828
91495829|NCT01752907|182863726|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3479|TWO_SIDED|95.0|-0.4|1.0|||t-test, 2 sided||Treatment difference = bone pain DVD - general education DVD|There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.||1.0|-0.4|0.3479
91495830|NCT02990910|182863755|SUPERIORITY||||||<|0.05|||||||Chi-squared|||Chi square test was used to compare the count data,p \< 0.05 was considered statistically significant.||||<0.05
91495831|NCT02064868|182863759|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0172|TWO_SIDED|95.0|0.51|0.98||One-sided p-value|Gehan's generalized Wilcoxon test|||||0.98|0.51|0.0172
91495832|NCT02064868|182863760|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0634|TWO_SIDED|95.0|0.61|1.02||Two-sided p-value|Gehan's generalized Wilcoxon test|||||1.02|0.61|0.0634
91495833|NCT02064868|182863761|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91495834|NCT02064868|182863762|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
91495835|NCT02064868|182863763|SUPERIORITY|||||||0.1392|||||||Wilcoxon (Mann-Whitney)|||||||0.1392
91495836|NCT02064868|182863765|SUPERIORITY|||||||0.3115|||||||Mixed Models Analysis|||Day 5||||0.3115
91530318|NCT03216902|182936835|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
91702422|NCT00772005|183299687|SUPERIORITY_OR_OTHER|||||||0.7472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7472
91702423|NCT00772005|183299687|SUPERIORITY_OR_OTHER|||||||0.4503||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4503
91495837|NCT02064868|182863765|SUPERIORITY|||||||0.1236|||||||Mixed Models Analysis|||Day 14||||0.1236
91495838|NCT00482612|182863766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
91495839|NCT00482612|182863766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
91495840|NCT00482612|182863766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
91495841|NCT00482612|182863767|SUPERIORITY_OR_OTHER|||||||0.0014|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0014
91495842|NCT00482612|182863767|SUPERIORITY_OR_OTHER|||||||0.0135|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0135
91495843|NCT00482612|182863767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline SL was used as a covariate.||||||<0.0001
91495844|NCT04180488|182863788|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.23||||0.0005|TWO_SIDED|95.0|-6.63|-1.84||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.84|-6.63|0.0005
91495845|NCT04180488|182863788|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.87||||0.0449|TWO_SIDED|95.0|-5.68|-0.07||Threshold for significance at 2-sided 0.043 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.07|-5.68|0.0449
91495846|NCT04180488|182863788|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.54||||0.0184|TWO_SIDED|95.0|-4.65|-0.43||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.43|-4.65|0.0184
91495847|NCT04180488|182863789|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-8.53||||0.0003|TWO_SIDED|95.0|-13.16|-3.9||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-3.90|-13.16|0.0003
91495848|NCT04180488|182863789|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.65||||0.0226|TWO_SIDED|95.0|-8.65|-0.65||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.65|-8.65|0.0226
91495849|NCT04180488|182863790|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.38||||0.0003|TWO_SIDED|95.0|-6.78|-1.98||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.98|-6.78|0.0003
91495850|NCT04180488|182863790|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.17||||0.0316|TWO_SIDED|95.0|-4.15|-0.19||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.19|-4.15|0.0316
91495851|NCT04180488|182863791|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.413||||0.0014|TWO_SIDED|95.0|1.596|7.299||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was performed on association between responder status and intervention group, adjusted by baseline disease severity (UAS7\<28,\>=28), presence of angioedema at baseline and region.||7.299|1.596|0.0014
91495852|NCT04180488|182863791|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.507||||0.0109|TWO_SIDED|95.0|1.231|5.107||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||5.107|1.231|0.0109
91495853|NCT04180488|182863792|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.848||||0.0075|TWO_SIDED|95.0|1.301|6.234||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.234|1.301|0.0075
91530319|NCT03216902|182936835|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
91530320|NCT03216902|182936835|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
91530321|NCT03216902|182936835|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
91530322|NCT01850082|182936847|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.47|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.47
91530323|NCT01850082|182936848|SUPERIORITY|||||||0.821|||||||Chi-squared|||||||0.821
91530324|NCT01850082|182936849|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
91530325|NCT01850082|182936850|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.517|TWO_SIDED|95.0|0.724|1.176|||Regression, Cox|||||1.176|0.724|0.517
91530326|NCT02138747|182936857|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.997||0.004|TWO_SIDED|95.0|-4.86|-0.93||p-value based on the ANOVA model|ANOVA|||Tolerability score was analyzed using the ANOVA model (Model #1), with sequence group, study period, period-by-sequence interaction, gender and treatment group as factors, and subject-within-sequence as a random term. p-value based on the ANOVA model. Difference used mirabegron as the reference (difference =tolterodine ER -mirabegron). A negative difference indicates better reported tolerability with mirabegron than with tolterodine ER.||-0.93|-4.86|0.004
91530327|NCT02138747|182936858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P value was obtained using Mainland-Gart test to compare the proportion of preference for each treatment group. The denominator excluded patients with No Preference.|Mainland-Gart|||Participants who selected Mirabegron or Tolterodine ER were included in the denominator and participants with No Preference were excluded. Comparison was between Mirabegron vs Tolterodine ER.||||0.77
91530328|NCT02138747|182936867|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.224||0.971|TWO_SIDED|95.0|-0.39|0.49||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.49|-0.39|0.971
91530329|NCT02138747|182936868|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.199||0.211|TWO_SIDED|95.0|-0.28|0.5||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.50|-0.28|0.211
91530330|NCT04793464|182936887|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.26|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.26
91530331|NCT04793464|182936888|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.02|TWO_SIDED||||||ANCOVA|Ratio of Means||Number analyzed is the number of participants with valid baseline and follow-up data.||||.02
91530332|NCT04793464|182936889|SUPERIORITY||Odds Ratio (OR)|1.1||||0.68|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.68
91530333|NCT04793464|182936890|SUPERIORITY||Odds Ratio (OR)|1.19||||0.44|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
91530334|NCT04793464|182936891|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.77|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.77
91530335|NCT04793464|182936892|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.66|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.66
91530336|NCT04793464|182936893|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.44|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
91530337|NCT04793464|182936894|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.017|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||0.017
91530338|NCT00405704|182936902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
91530339|NCT00405704|182936903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.55
91530340|NCT00405704|182936904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.37
91530341|NCT00405704|182936905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.94
91495854|NCT04180488|182863792|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.137||||0.0045|TWO_SIDED|95.0|1.371|7.176||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.176|1.371|0.0045
91495855|NCT04180488|182863793|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.908||||0.0199|TWO_SIDED|95.0|1.173|7.209||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.209|1.173|0.0199
91735259|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.065
91735260|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.042
91735261|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735262|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735263|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
91735264|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.689
91735265|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.075
91735266|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.059
91735267|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91495856|NCT04180488|182863793|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.677||||0.0187|TWO_SIDED|95.0|1.127|6.359||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.359|1.127|0.0187
91495857|NCT04180488|182863794|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|0.93||||0.194|TWO_SIDED|95.0|-0.48|2.34||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||2.34|-0.48|0.1940
91530342|NCT00405704|182936906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Log Rank|||||||0.04
91530343|NCT00405704|182936907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.065
91530344|NCT00405704|182936908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91530345|NCT00405704|182936909|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91530346|NCT02696902|182936910|SUPERIORITY||Relative risk reduction|-23.7||||0.491|TWO_SIDED|80.0|-83.8|16.8|||Poisson regression with robust variance|||||16.8|-83.8|0.491
91530347|NCT01857622|182936928|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.8|||||TWO_SIDED|95.0|-14.7|26.8|||Wilcoxon (Mann-Whitney)|no statistical test||||26.8|-14.7|
91530348|NCT01857622|182936928|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|-15.4|25.2|||Wilcoxon (Mann-Whitney)|||||25.2|-15.4|
91530349|NCT01603940|182937000|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.616
91530350|NCT01603940|182937001|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.28
91530351|NCT01603940|182937002|SUPERIORITY_OR_OTHER|||||||0.618|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.618
91530352|NCT02819479|182937017|OTHER||eta^2|0.37||||0.012|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 8.29||CHANGE IN VOLUME OF RADIATION NECROSIS: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.012
91735268|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735269|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
91735270|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.762||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.762
91735271|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.089
91735272|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.083
91495858|NCT04180488|182863795|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.37||||0.0377|TWO_SIDED|95.0|-4.6|-0.13||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.13|-4.60|0.0377
91530353|NCT02819479|182937017|OTHER||eta^2|0.19||||0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 3.29||CHANGE IN VOLUME OF CEREBRAL EDEMA: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.09
91735273|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735274|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
91735275|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.064
91735276|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.841
91735277|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.110
91735278|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.119
91735279|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
91735280|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
91735281|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.087
91530354|NCT02819479|182937018|OTHER||eta^2|0.29||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 2.74||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) TOTAL SCORES were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance)||||0.02
91735282|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.826
91735283|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.345||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.345
91495859|NCT04180488|182863796|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-5.02||||0.0223|TWO_SIDED|95.0|-9.32|-0.72||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.72|-9.32|0.0223
91530355|NCT02819479|182937019|OTHER||eta^2|0.37||||0.019|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 3.17||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) DAYS OF HEADACHE were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.019
91735284|NCT00402987|183363831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.530
91735285|NCT00402987|183363832|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.149||95.0|0.8|3.7|||Regression, Logistic|Treatment as a factor||||3.7|0.8|0.149
91735286|NCT00402987|183363832|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.076||95.0|0.9|4.1|||Regression, Logistic|Treatment as a factor||||4.1|0.9|0.076
91735287|NCT00402987|183363832|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.733||95.0|0.6|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.6|0.733
91495860|NCT04180488|182863797|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.645||||0.0215|TWO_SIDED|95.0|1.154|6.061||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.061|1.154|0.0215
91735288|NCT00402987|183363833|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.03||95.0|1.1|5.0|||Regression, Logistic|Treatment as a factor||||5.0|1.1|0.030
91735289|NCT00402987|183363833|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.064||95.0|1.0|5.7|||Regression, Logistic|Treatment as a factor||||5.7|1.0|0.064
91735290|NCT00402987|183363833|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.201||95.0|0.7|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.7|0.201
91735291|NCT00402987|183363833|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.575||95.0|0.5|3.0|||Regression, Logistic|Treatment as a factor||||3.0|0.5|0.575
91735292|NCT00402987|183363833|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1||95.0|0.4|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.4|1.000
91735293|NCT00402987|183363833|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3|||Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
91495861|NCT04180488|182863798|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|1.872||||0.0971|TWO_SIDED|95.0|0.893|3.923||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||3.923|0.893|0.0971
91495862|NCT03562481|182863840|EQUIVALENCE|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.|F statistic|0.8||||0.38|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.||||||0.38
91495863|NCT03562481|182863841|EQUIVALENCE|Equivalence was defined as a non-statistically significant difference.|F statistic|1.21||||0.28|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 and accounting for sequence and period effects.||||0.28
91530356|NCT02819479|182937020|OTHER||eta^2|0.3||||0.0006|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,35) = 3.96||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) MIDAS PAIN LEVEL data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.0006
91530357|NCT02819479|182937021|OTHER||eta^2|0.3||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5, 35) = 2.98||To explore durability of clinical response, Headache Impact Test (HIT-6™) scores were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.02
91530358|NCT02819479|182937022|OTHER||eta^2|0.19||||0.23|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(2,14) = 1.62||To explore durability of clinical response, Karnofsky Performance Status Scale (KPS) data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.23
91530359|NCT02819479|182937023|OTHER||Pearson's r|-0.199||||0.374|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|Z = -0.889||Wilcoxon signed rank test (2-sided) was used to compare the total number of days on steroids in the 12 months prior versus the 12 months immediately following single dose IA Avastin (bevacizumab).||||0.374
91530360|NCT02819479|182937024|OTHER||partial eta^2|0.153||||0.66|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.451||DIGITS FORWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS FORWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.660
91530361|NCT02819479|182937024|OTHER||partial eta^2|0.602||||0.1|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 3.78||DIGITS BACKWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS BACKWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.100
91530362|NCT02819479|182937024|OTHER||partial eta^2|0.532||||0.149|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 2.847||NUMBERS \& LETTERS SPEED: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS SPEED variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.149
91495864|NCT03562481|182863842|EQUIVALENCE|Equivalence was defined based on statistical significance in the cross-over ANOVA.|F statistic|11.1||||0.003|TWO_SIDED|||||This is adjusted for period and sequence effects and is statistically significant at the p\<0.05 level.|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 adjusting for perio and sequence effects.||||0.003
91530363|NCT02819479|182937024|OTHER||partial eta^2|0.721||||0.041|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 6.470||NUMBERS \& LETTERS ERRORS: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS ERRORS variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.041
91530364|NCT02819479|182937024|OTHER||partial eta^2|0.566||||0.124|TWO_SIDED||||||One way Repeat Meas ANOVA|F (2,5) = 3.256||NUMBERS \& LETTERS EFFICIENCY: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS EFFICIENCY variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.124
91530365|NCT02819479|182937024|OTHER||partial eta^2|0.042||||0.898|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.110||NAMING: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NAMING variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.898
91530366|NCT02819479|182937024|OTHER||partial eta^2|0.107||||0.754|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.299||LIST LEARNING LIST IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.754
91530367|NCT02819479|182937024|OTHER||partial eta^2|0.751||||0.031|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 7.556||LIST LEARNING LIST LONG DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST LONG DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.031
91735294|NCT00402987|183363834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.28|||<|0.001||95.0|0.7|1.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.7|<0.001
91495865|NCT03562481|182863843|EQUIVALENCE|Equivalence was determined based on the statistical significance of the Wilcoxon signed-rank test.|Z score|-0.996||||0.33|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sign test|Wilcoxon signed-rank test||||||0.33
91735295|NCT00402987|183363834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.003||95.0|0.3|1.5||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.3|0.003
91735296|NCT00402987|183363834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.177||95.0|-1.0|0.2||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.177
91735297|NCT00402987|183363834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.25|||<|0.001||95.0|3.0|7.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||7.5|3.0|<0.001
91735298|NCT00402987|183363834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||<|0.001||95.0|2.3|6.8||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||6.8|2.3|<0.001
91735299|NCT00402987|183363834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.531||95.0|-3.0|1.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|-3.0|0.531
91735300|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||<|0.001||95.0|4.4|13.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||13.7|4.4|<0.001
91735301|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.46|||<|0.001||95.0|4.7|16.2||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.2|4.7|<0.001
91495866|NCT03562481|182863844|EQUIVALENCE|Equivalence was determined based on the statistical significance of the chi square test.|Chi-square test|0.81||||0.37|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Chi-squared|||||||0.37
91495867|NCT03562481|182863845|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|0.2||||0.65|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Stuart-Maxwell test of marginal homogeneity implemented with the symmetry routine in Stata 16.1||||0.65
91702424|NCT00772005|183299687|SUPERIORITY_OR_OTHER|||||||0.3127||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3127
91735302|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96||||0.041||95.0|0.2|11.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.7|0.2|0.041
91735303|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.633||95.0|-7.1|4.3||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||4.3|-7.1|0.633
91735304|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.11||||0.284||95.0|-2.6|8.8||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||8.8|-2.6|0.284
91735305|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.18||95.0|-2.1|11.1||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.1|-2.1|0.180
91495868|NCT03562481|182863846|EQUIVALENCE|Equivalence was defined based on significance in the symmetry test.|Chi-square test|0.14||||0.71|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry or marginal homogeneity (Stuart-Maxwell) implemented with the symmetry routine in Stata 16.1.||||0.71
91495869|NCT03562481|182863847|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|1.0||||0.32|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.32
91702425|NCT00772005|183299688|SUPERIORITY_OR_OTHER|||||||0.9193||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9193
91735306|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.57||||0.009||95.0|3.4|23.7||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.7|3.4|0.009
91735307|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.15||||0.026||95.0|1.7|26.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||26.6|1.7|0.026
91735308|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.39||||0.138||95.0|-3.0|21.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||21.8|-3.0|0.138
91735309|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.926||95.0|-13.0|11.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.8|-13.0|0.926
91735310|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18||||0.507||95.0|-8.2|16.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.6|-8.2|0.507
91735311|NCT00402987|183363835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77||||0.513||95.0|-9.6|19.1||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||19.1|-9.6|0.513
91735312|NCT00402987|183363836|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.93||||0.023||95.0|1.2|7.4|||Regression, Logistic|Treatment as a factor||||7.4|1.2|0.023
91735313|NCT00402987|183363836|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.13||||0.015||95.0|1.2|7.9|||Regression, Logistic|Treatment as a factor||||7.9|1.2|0.015
91735314|NCT00402987|183363836|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.854||95.0|0.5|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.5|0.854
91735315|NCT00402987|183363837|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.46||||0.013||95.0|1.3|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.3|0.013
91735316|NCT00402987|183363837|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.03||||0.003||95.0|1.7|14.5|||Regression, Logistic|Treatment as a factor||||14.5|1.7|0.003
91495870|NCT03562481|182863848|EQUIVALENCE|Equivalence was defined based on the statistical significance of the symmetry test.|Chi-square test|1.29||||0.26|TWO_SIDED||||||Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.26
91530368|NCT02819479|182937024|OTHER||partial eta^2|0.289||||0.426|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.018||SHAPE LEARNING IMMEDIATE RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING IMMEDIATE RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.426
91735317|NCT00402987|183363837|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.99||||0.057||95.0|1.0|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.0|0.057
91735318|NCT00402987|183363837|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.758||95.0|0.5|2.9|||Regression, Logistic|Treatment as a factor||||2.9|0.5|0.758
91735319|NCT00402987|183363837|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.69||||0.381||95.0|0.3|1.6|||Regression, Logistic|Treatment as a factor||||1.6|0.3|0.381
91735320|NCT00402987|183363837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68||||0.313||95.0|0.6|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.6|0.313
91735321|NCT00402987|183363838|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|8.2||||||95.0|4.5|46.4||||||NNT is the inverse of the absolute risk reduction at 6 hours||46.4|4.5|
91735322|NCT00402987|183363838|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|7.5||||||95.0|4.3|32.0||||||NNT is the inverse of the absolute risk reduction at 6 hours||32.0|4.3|
91735323|NCT00402987|183363839|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|7.5||||||95.0|4.3|28.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||28.7|4.3|
91735324|NCT00402987|183363839|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|5.0||||||95.0|3.0|16.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||16.7|3.0|
91735325|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.77|||<|0.001||95.0|1.9|7.6||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.6|1.9|<0.001
91735326|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.72||||0.005||95.0|1.3|5.5||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.5|1.3|0.005
91735327|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72||||0.286||95.0|0.4|1.3||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.3|0.4|0.286
91735328|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.37||||0.001||95.0|1.6|7.1||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.1|1.6|0.001
91735329|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.004||95.0|1.4|6.5||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.5|1.4|0.004
91735330|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9||||0.752||95.0|0.5|1.7||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.7|0.5|0.752
91735331|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.57|||<|0.001||95.0|1.9|10.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||10.7|1.9|<0.001
91735332|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.68||||0.003||95.0|1.6|8.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.7|1.6|0.003
91735333|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.511||95.0|0.4|1.5||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.5|0.4|0.511
91735334|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.009||95.0|1.3|7.0||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||7.0|1.3|0.009
91735335|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
91735336|NCT00402987|183363840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.863||95.0|0.5|1.9||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.9|0.5|0.863
91495871|NCT00856284|182863851|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.03|||||ONE_SIDED|98.75||0.059||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||0.059||
91495872|NCT00856284|182863851|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.003||||||||0.003||
91735337|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.92||||0.004||95.0|1.4|6.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.1|1.4|0.004
91735338|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.052||95.0|1.0|5.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.7|1.0|0.052
91735339|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.095||95.0|0.9|5.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.1|0.9|0.095
91735340|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.431||95.0|0.6|3.0||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||3.0|0.6|0.431
91735341|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.602||95.0|0.6|2.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.7|0.6|0.602
91735342|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.8|0.4|0.814
91735343|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
91735344|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.23||||0.016||95.0|1.2|8.4||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.4|1.2|0.016
91735345|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.063||95.0|0.9|6.8||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.8|0.9|0.063
91735346|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.775||95.0|0.5|2.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.7|0.5|0.775
91735347|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.779||95.0|0.4|2.0||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.0|0.4|0.779
91735348|NCT00402987|183363841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
91735349|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.001
91735350|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.012
91735351|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.453
91735352|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||<0.001
91735353|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
91735354|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.814
91735355|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.024
91735356|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.022
91735357|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.966||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.966
91735358|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
91735359|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
91735360|NCT00402987|183363842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.798||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.798
91735361|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
91735362|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
91735363|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.008
91735364|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.709
91735365|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.331
91735366|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.246
91735367|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.001
91495873|NCT00856284|182863857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.13|||||ONE_SIDED|98.75||-0.006||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||-0.006||
91735368|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||<0.001
91702426|NCT00772005|183299688|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4814
91702427|NCT00772005|183299688|SUPERIORITY_OR_OTHER|||||||0.6097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6097
91702428|NCT00772005|183299689|SUPERIORITY_OR_OTHER|||||||0.8594||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8594
91702429|NCT00772005|183299689|SUPERIORITY_OR_OTHER|||||||0.6157||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6157
91702430|NCT00772005|183299689|SUPERIORITY_OR_OTHER|||||||0.4846||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4846
91702431|NCT00772005|183299690|SUPERIORITY_OR_OTHER|||||||0.6076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6076
91702432|NCT00772005|183299690|SUPERIORITY_OR_OTHER|||||||0.5827||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5827
91702433|NCT00772005|183299690|SUPERIORITY_OR_OTHER|||||||0.7865||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7865
91702434|NCT00772005|183299691|SUPERIORITY_OR_OTHER|||||||0.3045||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3045
91702435|NCT00772005|183299691|SUPERIORITY_OR_OTHER|||||||0.0617||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0617
91702436|NCT00772005|183299691|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0580
91702437|NCT00772005|183299692|SUPERIORITY_OR_OTHER|||||||0.0194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0194
91702438|NCT00772005|183299692|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2270
91702439|NCT00772005|183299692|SUPERIORITY_OR_OTHER|||||||0.1181||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1181
91702440|NCT00772005|183299693|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
91702441|NCT00772005|183299693|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0419
91702442|NCT00772005|183299693|SUPERIORITY_OR_OTHER|||||||0.0146||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0146
91702443|NCT00772005|183299694|SUPERIORITY_OR_OTHER|||||||0.1292||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1292
91530369|NCT02819479|182937024|OTHER||partial eta^2|0.361||||0.326|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.412||SHAPE LEARNING DELAYED RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING DELAYED RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.326
91530370|NCT02819479|182937024|OTHER||partial eta^2|0.09||||0.79|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.247||STORY LEARNING PHRASE UNIT IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.790
91530371|NCT02819479|182937024|OTHER||partial eta^2|0.239||||0.505|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.786||STORY LEARNING PHRASE UNIT DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.505
91530372|NCT02819479|182937024|OTHER||partial eta^2|0.636||||0.08|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 4.362||DESIGN CONSTRUCTION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DESIGN CONSTRUCTION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.080
91735369|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.219
91735370|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.095
91735371|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.463
91735372|NCT00402987|183363843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.038
91735373|NCT00402987|183363844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
91735374|NCT00402987|183363844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Regression, Logistic|Treatment as a factor||||||0.008
91735375|NCT00402987|183363844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||Regression, Logistic|Treatment as a factor||||||0.557
91735376|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||<0.001
91735377|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.002
91735378|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.036
91735379|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.339
91735380|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||1.000
91530373|NCT02819479|182937024|OTHER||partial eta^2|0.693||||0.052|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 5.654||MAZES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the MAZES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.052
91530374|NCT02819479|182937024|OTHER||partial eta^2|0.013||||0.968|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.033||CATEGORIES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the CATEGORIES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.968
91735381|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.401
91735382|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.003
91735383|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.002
91735384|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.223
91735385|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.198
91735386|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.604
91735387|NCT00402987|183363845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.117
91735388|NCT00402987|183363848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
91735389|NCT00402987|183363848|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||<0.001
91735390|NCT00402987|183363848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Regression, Logistic|Treatment as a factor||||||0.025
91735391|NCT00402987|183363848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||95.0|||||Regression, Logistic|Treatment as a factor||||||0.539
91735392|NCT00402987|183363848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Regression, Logistic|Treatment as a factor||||||0.329
91735393|NCT00402987|183363848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Regression, Logistic|Treatment as a factor||||||0.171
91735394|NCT00402987|183363849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Regression, Logistic|Treatment as a factor||||||0.007
91530375|NCT02819479|182937024|OTHER||partial eta^2|0.261||||0.469|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.884||WORD GENERATION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the WORD GENERATION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.469
91495874|NCT00856284|182863857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.035||||||||0.035||
91495875|NCT01577329|182863885|SUPERIORITY_OR_OTHER|||||||0.05||||||This is a calculated P value and was not adjusted for multiple comparisons.|ANOVA|||This is a calculated P value comparing two groups at baseline and follow-up||||0.05
91495876|NCT01059825|182863893|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0.002|TWO_SIDED|80.0|-0.65|-0.25||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.25|-0.65|0.002
91735395|NCT00402987|183363849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Regression, Logistic|Treatment as a factor||||||0.244
91735396|NCT00402987|183363849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0|||||Regression, Logistic|Treatment as a factor||||||0.096
91735397|NCT00402987|183363849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579||95.0|||||Regression, Logistic|Treatment as a factor||||||0.579
91495877|NCT01059825|182863893|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0|TWO_SIDED|80.0|-0.89|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.49|-0.89|0.000
91495878|NCT01059825|182863893|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62||||0|TWO_SIDED|80.0|-0.82|-0.42||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.42|-0.82|0.000
91735398|NCT00402987|183363849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||95.0|||||Regression, Logistic|Treatment as a factor||||||0.277
91735399|NCT00402987|183363849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.649||95.0|||||Regression, Logistic|Treatment as a factor||||||0.649
91735400|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|||<|0.001||95.0|7.5|23.2||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||23.2|7.5|<0.001
91735401|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.4||||0.003||95.0|4.9|24.0||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||24.0|4.9|0.003
91735402|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.2||||0.096||95.0|-1.5|17.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.8|-1.5|0.096
91735403|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.141||95.0|-2.4|16.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||16.8|-2.4|0.141
91735404|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.849||95.0|-8.6|10.5||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||10.5|-8.6|0.849
91735405|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3||||0.266||95.0|-4.8|17.4||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.4|-4.8|0.266
91530376|NCT02718417|182937029|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.989|TWO_SIDED|95.0|1.051|1.946||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.946|1.051|0.9890
91530377|NCT02718417|182937029|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7935|TWO_SIDED|95.0|0.832|1.565||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.565|0.832|0.7935
91530378|NCT02718417|182937030|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.8848|TWO_SIDED|95.0|0.76|3.08||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.080|0.760|0.8848
91735406|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.141||95.0|-5.4|0.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||0.8|-5.4|0.141
91735407|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.312||95.0|-5.7|1.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||1.8|-5.7|0.312
91735408|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.724||95.0|-4.5|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-4.5|0.724
91735409|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.398||95.0|-5.4|2.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||2.1|-5.4|0.398
91735410|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.846||95.0|-4.1|3.4||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.4|-4.1|0.846
91735411|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.572||95.0|-5.6|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-5.6|0.572
91735412|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.014||95.0|1.2|10.4||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.4|1.2|0.014
91530379|NCT02718417|182937030|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.8953|TWO_SIDED|95.0|0.776|3.111||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.111|0.776|0.8953
91530380|NCT02718417|182937031|OTHER||Hazard Ratio (HR)|1.21||||0.9278|TWO_SIDED|95.0|0.935|1.578||One-sided log-rank test was used.|Log Rank|||||1.578|0.935|0.9278
91530381|NCT02718417|182937031|OTHER||Hazard Ratio (HR)|0.9||||0.2367|TWO_SIDED|95.0|0.688|1.189||One-sided log-rank test was used.|Log Rank|||||1.189|0.688|0.2367
91530382|NCT00506285|182937065|NON_INFERIORITY_OR_EQUIVALENCE|F(1,47)=26.7, p=.001||||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|F(1,47)=26.7, p=.001||||||.001
91530383|NCT00506285|182937066|NON_INFERIORITY_OR_EQUIVALENCE|mixed models analysis||||||0.001|TWO_SIDED|95.0||||F(1,47)=24.8, p=.001|Mixed Models Analysis|||||||.001
91530384|NCT02892409|182937093|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95 percent (%) confidence interval (CI) of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|Least Square (LS) Mean Ratio|105.1|||||TWO_SIDED|95.0|66.051|167.183||||||||167.183|66.051|
91735413|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.573||95.0|-4.0|7.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||7.2|-4.0|0.573
91735414|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.482||95.0|-7.7|3.6||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||3.6|-7.7|0.482
91735415|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.007||95.0|2.2|13.5||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||13.5|2.2|0.007
91735416|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.2||||0.143||95.0|-1.4|9.8||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||9.8|-1.4|0.143
91735417|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.273||95.0|-2.9|10.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.2|-2.9|0.273
91735418|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.003||95.0|4.4|21.6||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||21.6|4.4|0.003
91735419|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.029||95.0|1.2|22.2||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||22.2|1.2|0.029
91735420|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2||||0.251||95.0|-4.4|16.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||16.8|-4.4|0.251
91735421|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8||||0.204||95.0|-3.7|17.4||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.4|-3.7|0.204
91735422|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.808||95.0|-9.2|11.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||11.8|-9.2|0.808
91735423|NCT00402987|183363850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.5||||0.371||95.0|-6.6|17.7||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.7|-6.6|0.371
91735424|NCT00402987|183363851|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||<0.001
91735425|NCT00402987|183363851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.002
91735426|NCT00402987|183363851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.235
91735427|NCT00402987|183363851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.012
91735428|NCT00402987|183363851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.438
91495879|NCT01059825|182863893|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.72||||0|TWO_SIDED|80.0|-0.93|-0.52||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.52|-0.93|0.000
91495880|NCT01059825|182863893|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0|TWO_SIDED|80.0|-0.97|-0.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-0.97|0.000
91495881|NCT01059825|182863894|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.13||||0.049|TWO_SIDED|80.0|-0.24|-0.03||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.03|-0.24|0.049
91495882|NCT01059825|182863894|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.29||||0|TWO_SIDED|80.0|-0.39|-0.18||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.18|-0.39|0.000
91530385|NCT02892409|182937094|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95% CI of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|LS Mean Ratio|93.6|||||TWO_SIDED|95.0|67.137|130.569||||||||130.569|67.137|
91530386|NCT02264574|182937110|SUPERIORITY||Hazard Ratio (HR)|0.231|||<|0.0001|TWO_SIDED|95.0|0.145|0.367|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.367|0.145|<0.0001
91530387|NCT02264574|182937111|SUPERIORITY||Hazard Ratio (HR)|0.119|||<|0.0001|TWO_SIDED|95.0|0.046|0.307|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.307|0.046|< 0.0001
91530388|NCT02264574|182937112|SUPERIORITY|||||||0.5253|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5253
91530389|NCT02264574|182937113|SUPERIORITY|||||||0.5465|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5465
91495883|NCT01059825|182863894|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.004|TWO_SIDED|80.0|-0.32|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.32|0.004
91495884|NCT01059825|182863894|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.17||||0.02|TWO_SIDED|80.0|-0.27|-0.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.06|-0.27|0.020
91495885|NCT01059825|182863894|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.25||||0.001|TWO_SIDED|80.0|-0.36|-0.15||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.15|-0.36|0.001
91530390|NCT02264574|182937114|SUPERIORITY||Rate Ratio|1.208||||0.0035|TWO_SIDED|95.0|1.062|1.373|||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.373|1.062|0.0035
91530391|NCT02264574|182937115|SUPERIORITY||Hazard Ratio (HR)|0.921||||0.8057|TWO_SIDED|95.0|0.479|1.772|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.772|0.479|0.8057
91530392|NCT02264574|182937116|SUPERIORITY|||||||0.0835|||||||Fisher Exact|||"IRR Preferred Term~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.0835
91530393|NCT02264574|182937116|SUPERIORITY|||||||0.1944|||||||Fisher Exact|||"IRR By Customized SMQ~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.1944
91530394|NCT02264574|182937117|SUPERIORITY|||||||0.0045|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.0045
91495886|NCT01059825|182863895|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0|TWO_SIDED|80.0|-0.5|-0.23||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-0.50|0.000
91495887|NCT01059825|182863895|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0|TWO_SIDED|80.0|-0.59|-0.32||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.32|-0.59|0.000
91530395|NCT02264574|182937118|SUPERIORITY|||||||0.859|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.8590
91530396|NCT02264574|182937119|SUPERIORITY||Hazard Ratio (HR)|0.169|||<|0.0001|TWO_SIDED|95.0|0.102|0.282|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.282|0.102|< 0.0001
91530397|NCT02264574|182937120|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
91530398|NCT02264574|182937121|SUPERIORITY|||||||0.1612|||||||Chi-squared|||||||0.1612
91530399|NCT02264574|182937122|SUPERIORITY||Rate Ratio|1.125||||0.0273|TWO_SIDED|95.0|1.013|1.25|||Chi-squared|||||1.250|1.013|0.0273
91530400|NCT02264574|182937123|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.7934|TWO_SIDED|95.0|0.595|1.973|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||1.973|0.595|0.7934
91530401|NCT02264574|182937124|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.0050
91530402|NCT02264574|182937125|SUPERIORITY||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.162|0.389|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.389|0.162|< 0.0001
91495888|NCT01059825|182863895|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
91530403|NCT02080520|182937126|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|||||||0.31
91530404|NCT02080520|182937127|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
91530405|NCT02080520|182937128|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
91530406|NCT04102540|182937142|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following exposure 2 to the intervention.|Median Difference (Net)|57.39||||0.283|TWO_SIDED|95.0|-48.9|163.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 2.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 2 to the intervention.||163.7|-48.9|0.283
91530407|NCT04102540|182937142|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following the exposure 3 to the intervention.|Median Difference (Net)|60.83||||0.1823|TWO_SIDED|95.0|-29.5|151.2||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 3.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 3 to the intervention.||151.2|-29.5|0.1823
91530408|NCT04102540|182937143|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 2 to the intervention.|Median Difference (Net)|-42.0||||0.7795|TWO_SIDED|95.0|-339.8|255.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression||This is the difference in median viral load between baseline/exposure 1 and exposure 2.|Statistical analysis of viral load between baseline/exposure 1 and exposure 2 to the intervention.||255.8|-339.8|0.7795
91530409|NCT04102540|182937143|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 3 to the intervention.|Median Difference (Net)|-63.0||||0.5971|TWO_SIDED|95.0|-296.1|170.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|||Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention.|This is the difference in median viral load between baseline/exposure 1 and exposure 3.|170.1|-296.1|0.5971
91530410|NCT04102540|182937144|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 2 to the intervention.|Median Difference (Net)|2.12|||<|0.0001|TWO_SIDED|95.0|1.2|3.0||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-Related knowledge scores between baseline/exposure 1 and exposure 2.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 2 to the intervention.||3.0|1.2|<.0001
91530411|NCT04102540|182937144|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 3 to the intervention.|Median Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-related knowledge score between baseline/exposure 1 and exposure 3.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention.||2.8|1.2|<.0001
91735429|NCT00402987|183363851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.067||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.067
91495889|NCT01059825|182863895|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.36||||0|TWO_SIDED|80.0|-0.49|-0.22||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.22|-0.49|0.000
91495890|NCT01059825|182863895|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
91495891|NCT01059825|182863896|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.47||||0|TWO_SIDED|80.0|-0.64|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.64|0.000
91495892|NCT01059825|182863896|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.66||||0|TWO_SIDED|80.0|-0.83|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.49|-0.83|0.000
91495893|NCT01059825|182863896|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.63||||0|TWO_SIDED|80.0|-0.8|-0.45||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.45|-0.80|0.000
91495894|NCT01059825|182863896|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.65||||0|TWO_SIDED|80.0|-0.82|-0.47||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.47|-0.82|0.000
91530412|NCT04102540|182937146|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 2 to the intervention.|Median Difference (Net)|0.01||||0.9879|TWO_SIDED|95.0|-0.7|0.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 2.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 2 to the intervention.||0.7|-0.7|0.9879
91530413|NCT04102540|182937146|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 3 to the intervention.|Median Difference (Net)|0.57||||0.155|TWO_SIDED|95.0|-0.2|1.4||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||1.4|-0.2|0.1550
91530414|NCT04102540|182937147|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.17||||0.819|TWO_SIDED|95.0|0.3|4.52||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 2 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||4.52|0.30|0.8190
91530415|NCT04102540|182937147|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|0.3||||0.1332|TWO_SIDED|95.0|0.07|1.43||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 3 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||1.43|0.07|0.1332
91530416|NCT04102540|182937148|OTHER|In this model, the null hypothesis was that the odds of good health at baseline/exposure 1 were exactly equal to the odds of good health at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.77||||0.316|TWO_SIDED|95.0|0.57|5.46||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 2 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||5.46|0.57|0.3160
91530417|NCT04102540|182937148|OTHER|In this model, the null hypothesis was that the odds of having good health at baseline/exposure 1 were exactly equal to the odds of having good health at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.12||||0.8609|TWO_SIDED|95.0|0.32|3.93||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 3 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||3.93|0.32|0.8609
91702444|NCT00772005|183299694|SUPERIORITY_OR_OTHER|||||||0.3773||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3773
91735430|NCT00402987|183363852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.128
91735431|NCT00402987|183363852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.123
91735432|NCT00402987|183363852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.266||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.266
91735433|NCT00402987|183363852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.849||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.849
91735434|NCT00402987|183363852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.828||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.828
91735435|NCT00402987|183363852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.741
91735436|NCT01668004|183363853|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.||||1.0000
91735437|NCT01668004|183363854|SUPERIORITY_OR_OTHER||Treatment Ratio|4.5|||<|0.0001|TWO_SIDED|95.0|3.86|5.25|||Generalized estimating equation|||Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.||5.25|3.86|<0.0001
91735438|NCT01605669|183363890|SUPERIORITY_OR_OTHER||Percentage Sensitivity|85.7||||||95.0||||||||||||
91735439|NCT01605669|183363890|SUPERIORITY_OR_OTHER||Percent Specificity|72.4||||||95.0||||||||||||
91495895|NCT01059825|182863896|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.67||||0|TWO_SIDED|80.0|-0.84|-0.5||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.50|-0.84|0.000
91495896|NCT01059825|182863898|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.15||||0.007|TWO_SIDED|80.0|-1.75|-0.55||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.75|0.007
91735440|NCT01605669|183363890|SUPERIORITY_OR_OTHER||Percent Error Rate|25.0||||||95.0|||||||Error rate of 9/36 is equal to total of false positives plus false negatives over the total of participants analyzed.|||||
91735441|NCT02329587|183363895|OTHER||Between-group effect size (Hedge's g)|0.138|||||TWO_SIDED|||||||||||||
91735442|NCT02329587|183363896|OTHER||Between-group effect size (Hedge's g)|-0.214|||||TWO_SIDED|||||||||||||
91735443|NCT02329587|183363897|OTHER||Between-groups effect size (Hedge's g)|-0.007|||||TWO_SIDED|||||||||||||
91735444|NCT02329587|183363898|OTHER||Between-group effect size (Hedge's g)|-0.151|||||TWO_SIDED|||||||||||||
91735445|NCT02329587|183363899|OTHER||Between-groups effect size (Hedge's g)|0.704|||||TWO_SIDED|||||||||||||
91735446|NCT02329587|183363900|OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED|||||||||||||
91735447|NCT02421094|183363910|SUPERIORITY|||||||0.1621|||||||ANCOVA|||||||0.1621
91735448|NCT02421094|183363911|SUPERIORITY|||||||0.9835|||||||ANCOVA|||||||0.9835
91735449|NCT02421094|183363912|SUPERIORITY|||||||0.266|||||||ANCOVA|||||||0.2660
91735450|NCT03773484|183363925|OTHER||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.011||0.43|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||Pre post comparison for Opioid Naïve patients||0.01|-0.03|0.43
91735451|NCT03773484|183363925|OTHER||Slope|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.24|TWO_SIDED|95.0|-0.051|0.013|||Mixed Models Analysis|||Pre-post comparison for at-risk for long term use patients||0.013|-0.051|0.24
91735452|NCT04724837|183363926|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-33.7|||<|0.001|TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + Placebo (PBO)||-23.5|-42.5|<0.001
91735453|NCT04724837|183363927|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-27.0||||0.002|TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|0.002
91735454|NCT04724837|183363928|SUPERIORITY||Least Square (LS) mean CFB|-3.6|||||TWO_SIDED|90.0|-6.8|-0.5|||Mixed Models Analysis||If mean change from baseline (CFB) \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.5|-6.8|
91735455|NCT04724837|183363928|SUPERIORITY||LS mean CFB|-7.6|||||TWO_SIDED|90.0|-10.3|-4.9|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-4.9|-10.3|
91735456|NCT04724837|183363929|SUPERIORITY||LS Mean CFB|-3.0|||||TWO_SIDED|90.0|-5.0|-1.0|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-1.0|-5.0|
91735457|NCT04724837|183363929|SUPERIORITY||LS Mean CFB|-5.4|||||TWO_SIDED|90.0|-7.1|-3.7|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-3.7|-7.1|
91735458|NCT04724837|183363930|SUPERIORITY||Adjusted % mean change from baseline|-27.0|||||TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|
91735459|NCT04724837|183363930|SUPERIORITY||Adjusted % mean change from baseline|-33.7|||||TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-23.5|-42.5|
91735460|NCT04724837|183363931|SUPERIORITY||LS mean CFB|1.1|||||TWO_SIDED|90.0|-0.5|2.6|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||2.6|-0.5|
91735461|NCT04724837|183363931|SUPERIORITY||LS mean CFB|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.1|
91735462|NCT04724837|183363931|SUPERIORITY||LS mean CFB|-1.2|||||TWO_SIDED|90.0|-2.8|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.8|
91735463|NCT04724837|183363931|SUPERIORITY||LS mean CFB|-1.1|||||TWO_SIDED|90.0|-2.5|0.3|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.3|-2.5|
91735464|NCT04724837|183363931|SUPERIORITY||LS mean CFB|0.1|||||TWO_SIDED|90.0|-1.6|1.8|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.8|-1.6|
91735465|NCT04724837|183363931|SUPERIORITY||LS mean CFB|-2.1|||||TWO_SIDED|90.0|-3.5|-0.7|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.7|-3.5|
91735466|NCT04724837|183363933|SUPERIORITY||LS mean change|-2.2|||||TWO_SIDED|90.0|-4.0|-0.4|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.4|-4.0|
91735467|NCT04724837|183363933|SUPERIORITY||LS mean change|-0.3|||||TWO_SIDED|90.0|-1.8|1.3|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.3|-1.8|
91735468|NCT04222673|183363934|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
91735469|NCT04222673|183363935|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
91735470|NCT04222673|183363936|OTHER|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
91735471|NCT04222673|183363937|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
91735472|NCT04222673|183363938|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
91735473|NCT04222673|183363939|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
91735474|NCT04222673|183363940|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
91495897|NCT01059825|182863898|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.75||||0|TWO_SIDED|80.0|-2.35|-1.14||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.14|-2.35|0.000
91735475|NCT04222673|183363941|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
91735476|NCT05177354|183363992|SUPERIORITY||Proportion|89.3|||<|0.001|ONE_SIDED|97.5|71.8|||"It is hypothesized that the proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Closed Loop On compared to Closed Loop Off period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test||||||71.8|<0.001
91735477|NCT05715827|183364014|OTHER|The study used descriptive statistics and 95% confidence intervals to summarize data. The sample size of 40 patients (20 per surgery type) was based on prior studies with 3% device malfunction and 0.9% failure-related conversion rates. The primary endpoint was the completion rate, defined as ≥95% without conversion due to system issues or major complications within 24 hours. The Full Analysis Set included all subjects who started the procedure. No interim analyses were planned.|Completion rate|97.5|||||TWO_SIDED|95.0|86.8|99.9||The study used descriptive statistics and confidence intervals, not hypothesis testing with p-values. The main goal was to confirm the completion rate met or exceeded 95% and present a 95% confidence interval||The main goal was to confirm the completion rate met or exceeded 95% with a 95% confidence interval.|Estimated Value of 97.5% is an overall completion rate|The study aimed to confirm the Medtronic Hugo™ RAS System's performance for prostatectomy or cholecystectomy, targeting a 95% completion rate (no conversion due to system issues or major complications within 24 hours). The Full Analysis Set (FAS) included all subjects starting the procedure. Descriptive statistics and 95% confidence intervals were used to assess primary and secondary endpoints, confirming safety and effectiveness.|Descriptive Analysis was used|99.9|86.8|
91735478|NCT05715827|183364015|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Overall Complication Rate|20.0|||||TWO_SIDED|95.0|9.1|35.6||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||35.6|9.1|
91735479|NCT05715827|183364016|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Major complication rate|5.0|||||TWO_SIDED|95.0|0.6|16.9||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||16.9|0.6|
91735480|NCT05715827|183364017|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Readmission rate|10.0|||||TWO_SIDED|95.0|2.8|23.7||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||23.7|2.8|
91735481|NCT05715827|183364018|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Reoperation rate|0.0|||||TWO_SIDED|||||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||||
91735482|NCT05715827|183364019|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Device deficiency rate|32.5|||||TWO_SIDED|95.0|18.6|49.1||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||49.1|18.6|
91495898|NCT01059825|182863898|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.15||||0|TWO_SIDED|80.0|-2.76|-1.54||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.54|-2.76|0.000
91495899|NCT01059825|182863898|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.91||||0|TWO_SIDED|80.0|-2.52|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.52|0.000
91495900|NCT01059825|182863898|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.833|TWO_SIDED|80.0|-0.15|1.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.06|-0.15|0.833
91495901|NCT01059825|182863899|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.42||||0.043|TWO_SIDED|80.0|-0.73|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.73|0.043
91495902|NCT01059825|182863899|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.13||||0|TWO_SIDED|80.0|-1.44|-0.81||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.81|-1.44|0.000
91735483|NCT04846868|183364020|SUPERIORITY|The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on on-treatment periods.|Mean Difference (Net)|0.063|STANDARD_ERROR_OF_MEAN|0.4355||0.8854|TWO_SIDED|95.0|-0.793|0.918||"Null hypothesis: The adjusted mean change from baseline to Week 26 in MCCB overall composite T-score in iclepertin 10mg is worse than or equal to that in placebo.~one-sided p\< 0.025 required for testing subsequent key secondary endpoint hypotheses"|Mixed Models Analysis||Iclepertin 10 mg versus Placebo|MMRM, including the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was the repeated measure with an unstructured covariance structure to model the within-patient measurements.||0.918|-0.793|0.8854
91735484|NCT04846868|183364021|OTHER|The estimated treatment effect included the effect of any concomitant therapies and partner change in SCoR assessment for all randomized patients on-treatment.|Mean Difference (Net)|0.234|STANDARD_ERROR_OF_MEAN|0.5867||0.6902|TWO_SIDED|95.0|-0.918|1.386|||Mixed Models Analysis||Iclepertin 10 mg versus Placebo|MMRM including the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.386|-0.918|0.6902
91735485|NCT04846868|183364022|OTHER|The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment.|Mean Difference (Net)|-0.543|STANDARD_ERROR_OF_MEAN|1.1388||0.6334|TWO_SIDED|95.0|-2.78|1.694|||Mixed Models Analysis||Iclepertin 10 mg vs. placebo|MMRM including the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.694|-2.780|0.6334
91735486|NCT04846868|183364023|OTHER|The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment.|Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.0448||0.2902||95.0|-0.041|0.135|||Mixed Models Analysis||Iclepertin 10 mg vs Placebo|MMRM including the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements.||0.135|-0.041|0.2902
91735487|NCT04846868|183364024|OTHER|The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment.|Mean Difference (Net)|0.628||||0.4956|TWO_SIDED|95.0|-1.181|2.437|||ANCOVA||Iclepertin 10 mg vs. Placebo|ANCOVA model including treatment, stratification factor of screening MCCB overall composite T-score, and baseline number of correct responses on Tower of London T-score.||2.437|-1.181|0.4956
91735488|NCT03274466|183364067|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||0.59|0.08|0.0013
91735489|NCT03274466|183364068|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.33||||0.168|TWO_SIDED|95.0|0.07|1.7||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||1.70|0.07|0.1680
91735490|NCT03274466|183364069|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.34||||0.3386|TWO_SIDED|95.0|0.04|3.39||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||3.39|0.04|0.3386
91735491|NCT03274466|183364070|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.||0.59|0.08|0.0013
91735492|NCT02445911|183364097|OTHER||Least-squares Mean Difference|-6.78|||||TWO_SIDED|95.0|-23.75|10.18|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||10.18|-23.75|
91735493|NCT02445911|183364097|OTHER||Least-squares Mean Difference|-2.97|||||TWO_SIDED|95.0|-19.65|13.72|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||13.72|-19.65|
91735494|NCT02445911|183364097|OTHER||Least-squares Mean Difference|-5.05|||||TWO_SIDED|95.0|-21.97|11.88|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||11.88|-21.97|
91735495|NCT02581930|183364115|OTHER|Exact binomial test|Probability of response|0.0||||1|ONE_SIDED|||||Significant if p-value is less than 0.1|Exact binomial test, 1-sided||Estimated as proportion of subjects with response|The primary comparison was between the response rate of an ineffective drug, such as investigators' choice chemotherapy (5%), and the response rate of ibrutinib.||||1.00
91735496|NCT01139515|183364154|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.7|||||TWO_SIDED|90.0|92.17|105.7||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.70|92.17|
91735497|NCT01139515|183364154|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.48|||||TWO_SIDED|90.0|102.23|117.24||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.24|102.23|
91495903|NCT01059825|182863899|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0|TWO_SIDED|80.0|-1.22|-0.59||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-1.22|0.000
91760039|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.13|0.25||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.13|
91735498|NCT01139515|183364154|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.93|||||TWO_SIDED|90.0|102.65|117.72||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.72|102.65|
91735499|NCT01139515|183364155|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|99.41|||||TWO_SIDED|90.0|92.97|106.31||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||106.31|92.97|
91735500|NCT01139515|183364155|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.52|||||TWO_SIDED|90.0|103.36|118.18||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.18|103.36|
91735501|NCT01139515|183364155|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.44|||||TWO_SIDED|90.0|103.28|118.09||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.09|103.28|
91735502|NCT01139515|183364156|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|101.81|||||TWO_SIDED|90.0|85.97|120.58||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||120.58|85.97|
91735503|NCT01139515|183364156|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.57|||||TWO_SIDED|90.0|83.23|116.73||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||116.73|83.23|
91735504|NCT01139515|183364156|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|107.44|||||TWO_SIDED|90.0|90.72|127.25||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||127.25|90.72|
91495904|NCT01059825|182863899|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.87||||0|TWO_SIDED|80.0|-1.18|-0.55||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.18|0.000
91495905|NCT01059825|182863899|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.967|TWO_SIDED|80.0|0.14|0.76||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.76|0.14|0.967
91495906|NCT01059825|182863900|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.008|TWO_SIDED|80.0|-1.17|-0.36||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.36|-1.17|0.008
91495907|NCT01059825|182863900|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.32||||0|TWO_SIDED|80.0|-1.73|-0.91||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.91|-1.73|0.000
91495908|NCT01059825|182863900|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24||||0|TWO_SIDED|80.0|-1.65|-0.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.83|-1.65|0.000
91735505|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.4|0.9||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.9|-3.4|<0.001
91735506|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|2.2|||<|0.001|TWO_SIDED|95.0|1.7|2.8||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||2.8|1.7|<0.001
91735507|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.4||||0.61|TWO_SIDED|95.0|-1.0|1.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.7|-1.0|0.61
91735508|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.4|TWO_SIDED|95.0|-0.1|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|-0.1|0.40
91735509|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.12|TWO_SIDED|95.0|0.0|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|0.0|0.12
91735510|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.1|0.0||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.0|-0.1|<0.001
91735511|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|1.0|1.5||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.5|1.0|<0.001
91735512|NCT01576783|183364159|OTHER|The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.9|1.4||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.4|0.9|<0.001
91495909|NCT01059825|182863900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.08||||0|TWO_SIDED|80.0|-1.49|-0.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward..||||-0.67|-1.49|0.000
91495910|NCT01059825|182863900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.922|TWO_SIDED|80.0|0.04|0.86||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.86|0.04|0.922
91495911|NCT01059825|182863901|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.03||||0.003|TWO_SIDED|80.0|-1.51|-0.56||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-1.51|0.003
91495912|NCT01059825|182863901|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.57||||0|TWO_SIDED|80.0|-2.04|-1.09||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.09|-2.04|0.000
91495913|NCT01059825|182863901|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.68||||0|TWO_SIDED|80.0|-2.16|-1.21||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.21|-2.16|0.000
91495914|NCT01059825|182863901|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.78||||0|TWO_SIDED|80.0|-2.26|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.26|0.000
91495915|NCT01059825|182863901|SUPERIORITY_OR_OTHER||Difference in least squares means|0.24||||0.741|TWO_SIDED|80.0|-0.24|0.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.71|-0.24|0.741
91495916|NCT01059825|182863903|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.13||||0.163|TWO_SIDED|80.0|-4.92|0.65||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.65|-4.92|0.163
91495917|NCT01059825|182863903|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.48||||0.056|TWO_SIDED|80.0|-6.28|-0.68||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.68|-6.28|0.056
91495918|NCT01059825|182863903|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.88||||0.096|TWO_SIDED|80.0|-5.7|-0.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.05|-5.70|0.096
91495919|NCT01059825|182863903|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.37||||0.064|TWO_SIDED|80.0|-6.21|-0.53||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.53|-6.21|0.064
91495920|NCT01059825|182863903|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.54||||0.403|TWO_SIDED|80.0|-3.33|2.26||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.26|-3.33|0.403
91495921|NCT01059825|182863904|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.425|TWO_SIDED|80.0|-2.91|2.17||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.17|-2.91|0.425
91495922|NCT01059825|182863904|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.81||||0.082|TWO_SIDED|80.0|-5.38|-0.23||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-5.38|0.082
91495923|NCT01059825|182863904|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.35||||0.43|TWO_SIDED|80.0|-2.92|2.21||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.21|-2.92|0.430
91495924|NCT01059825|182863904|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.47||||0.043|TWO_SIDED|80.0|-6.05|-0.89||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.89|-6.05|0.043
91495925|NCT01059825|182863904|SUPERIORITY_OR_OTHER||Difference in least squares means|1.01||||0.694|TWO_SIDED|80.0|-1.55|3.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.58|-1.55|0.694
91495926|NCT01059825|182863905|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38||||0.234|TWO_SIDED|80.0|-3.81|1.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.05|-3.81|0.234
91495927|NCT01059825|182863905|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.59||||0.087|TWO_SIDED|80.0|-5.03|-0.14||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.14|-5.03|0.087
91495928|NCT01059825|182863905|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.86||||0.068|TWO_SIDED|80.0|-5.33|-0.4||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.40|-5.33|0.068
91495929|NCT01059825|182863905|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.77||||0.346|TWO_SIDED|80.0|-3.25|1.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.71|-3.25|0.346
91495930|NCT01059825|182863905|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.346|TWO_SIDED|80.0|-3.21|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-3.21|0.346
91495931|NCT01059825|182863906|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.306|TWO_SIDED|80.0|-3.87|1.67||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.67|-3.87|0.306
91530418|NCT04102540|182937149|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 2 to the intervention.|Median Difference (Net)|9.13||||0.0572|TWO_SIDED|95.0|-0.3|18.6||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 2.|Statistical analysis of current health status between baseline/exposure 1 and exposure 2 to the intervention.||18.6|-0.3|0.0572
91530419|NCT04102540|182937149|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 3 to the intervention.|Median Difference (Net)|13.1||||0.0332|TWO_SIDED|95.0|1.1|25.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||25.1|1.1|0.0332
91530420|NCT01567163|182937155|SUPERIORITY_OR_OTHER||Ratio geometric least squares (LS) means|0.97|||||TWO_SIDED|90.0|0.84|1.1|||Mixed Models Analysis||The ratio of geometric LS means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of geometric LS means is AUC(0-∞) of Cycle 2/Cycle 1.|||1.10|0.84|
91530421|NCT01567163|182937157|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.14|||||TWO_SIDED|90.0|0.84|1.55|||Mixed Models Analysis||The ratio of geometric least squares means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.|||1.55|0.84|
91530422|NCT02571439|182937169|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91530423|NCT02571439|182937170|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91530424|NCT02571439|182937171|OTHER|||||||0.61|||||||Kruskal-Wallis|||||||0.61
91530425|NCT02571439|182937172|OTHER|||||||0.46|||||||Kruskal-Wallis|||||||0.46
91530426|NCT02571439|182937173|OTHER|||||||0.33|||||||Kruskal-Wallis|||||||0.33
91530427|NCT02571439|182937174|OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.13
91530428|NCT02571439|182937175|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
91530429|NCT02571439|182937176|OTHER|||||||0.87|||||||Kruskal-Wallis|||||||0.87
91530430|NCT02571439|182937177|OTHER|||||||0.27|||||||Chi-squared|||||||0.27
91530431|NCT02571439|182937178|OTHER|||||||0.91|||||||Kruskal-Wallis|||||||0.91
91530432|NCT00318149|182937215|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS25 Group) was smaller than (\<) 2.0.|Geometric mean ratio|0.9|||||TWO_SIDED|98.75|0.7|1.16||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.16|0.7|
91530433|NCT00318149|182937215|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS50 Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.05|||||TWO_SIDED|98.75|0.71|1.56||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.56|0.71|
91530434|NCT00318149|182937215|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01B Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.04|||||TWO_SIDED|98.75|0.79|1.38||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.38|0.79|
91702445|NCT00772005|183299694|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
91495932|NCT01059825|182863906|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.41||||0.133|TWO_SIDED|80.0|-5.19|0.37||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.37|-5.19|0.133
91735513|NCT01576783|183364160|OTHER|The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.5|-3.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||-3.7|-5.5|<0.001
91735514|NCT01576783|183364163|OTHER|The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).||||||0.13||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.13
91735515|NCT01576783|183364163|OTHER|The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).||||||0.76||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||||||.76
91735516|NCT01576783|183364164|OTHER|The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).||||||0.66||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.66
91735517|NCT01576783|183364164|OTHER|The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).||||||0.55||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.55
91735518|NCT01576783|183364164|OTHER|The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).||||||0.88||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.88
91735519|NCT01576783|183364165|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.11
91735520|NCT01576783|183364165|OTHER|The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).||||||0.47||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.47
91495933|NCT01059825|182863906|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.61||||0.117|TWO_SIDED|80.0|-5.42|0.2||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.20|-5.42|0.117
91735521|NCT01576783|183364165|OTHER|The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.32
91735522|NCT01576783|183364166|OTHER|The reported p-value is for the comparison of the change in weight-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.99||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.99
91735523|NCT01576783|183364166|OTHER|The reported p-value is for the comparison of the change in length-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.27||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.27
91495934|NCT01059825|182863906|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.87||||0.097|TWO_SIDED|80.0|-5.69|-0.04||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.04|-5.69|0.097
91735524|NCT01576783|183364166|OTHER|The reported p-value is for the comparison of the change in head circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.39||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.39
91495935|NCT01059825|182863906|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.179|TWO_SIDED|80.0|-4.78|0.79||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.79|-4.78|0.179
91495936|NCT01059825|182863908|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.93||||0.072|TWO_SIDED|80.0|-3.62|-0.24||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.24|-3.62|0.072
91495937|NCT01059825|182863908|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.81||||0.086|TWO_SIDED|80.0|-3.51|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-3.51|0.086
91495938|NCT01059825|182863908|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.99||||0.002|TWO_SIDED|80.0|-5.71|-2.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-2.27|-5.71|0.002
91495939|NCT01059825|182863908|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.025|TWO_SIDED|80.0|-4.37|-0.92||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.92|-4.37|0.025
91495940|NCT01059825|182863908|SUPERIORITY_OR_OTHER||Difference in least squares means|0.88||||0.746|TWO_SIDED|80.0|-0.82|2.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.58|-0.82|0.746
91495941|NCT01059825|182863909|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0.289|TWO_SIDED|80.0|-2.27|0.9||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.90|-2.27|0.289
91495942|NCT01059825|182863909|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.288|TWO_SIDED|80.0|-2.31|0.91||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.91|-2.31|0.288
91495943|NCT01059825|182863909|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.41||||0.13|TWO_SIDED|80.0|-3.01|0.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.19|-3.01|0.130
91495944|NCT01059825|182863909|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.44||||0.026|TWO_SIDED|80.0|-4.05|-0.84||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.84|-4.05|0.026
91495945|NCT01059825|182863909|SUPERIORITY_OR_OTHER||Difference in least squares means|1.49||||0.883|TWO_SIDED|80.0|-0.11|3.08||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.08|-0.11|0.883
91702446|NCT00772005|183299695|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9642
91702447|NCT00772005|183299695|SUPERIORITY_OR_OTHER|||||||0.7814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7814
91702448|NCT00772005|183299695|SUPERIORITY_OR_OTHER|||||||0.1455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1455
91702449|NCT00772005|183299696|SUPERIORITY_OR_OTHER|||||||0.5722||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5722
91702450|NCT00772005|183299696|SUPERIORITY_OR_OTHER|||||||0.1352||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1352
91702451|NCT00772005|183299696|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0630
91702452|NCT00772005|183299697|SUPERIORITY_OR_OTHER|||||||0.4607||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4607
91702453|NCT00772005|183299697|SUPERIORITY_OR_OTHER|||||||0.2538||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2538
91702454|NCT00772005|183299697|SUPERIORITY_OR_OTHER|||||||0.3406||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3406
91702455|NCT00772005|183299698|SUPERIORITY_OR_OTHER|||||||0.8116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8116
91702456|NCT00772005|183299698|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6870
91702457|NCT00772005|183299698|SUPERIORITY_OR_OTHER|||||||0.8112||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8112
91702458|NCT00772005|183299699|SUPERIORITY_OR_OTHER|||||||0.9786||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9786
91702459|NCT00772005|183299699|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
91735525|NCT01576783|183364166|OTHER|The reported p-value is for the comparison of the change in mid upper arm circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.25||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.25
91735526|NCT01576783|183364166|OTHER|The reported p-value is for the comparison of the change in triceps skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.85||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.85
91735527|NCT01576783|183364166|OTHER|The reported p-value is for the comparison of the change in subscapular skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.82||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.82
91735528|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.42||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.42
91735529|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.68||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.68
91735530|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.78||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.78
91735531|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.32
91495946|NCT01059825|182863910|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.67||||0.063|TWO_SIDED|80.0|-3.07|-0.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.27|-3.07|0.063
91735532|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.97||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.97
91735533|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.62||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.62
91735534|NCT01576783|183364167|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.69||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.69
91735535|NCT01576783|183364168|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.22
91735536|NCT01576783|183364169|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.23
91735537|NCT01576783|183364169|OTHER|The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.07||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.07
91495947|NCT01059825|182863910|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.29||||0.019|TWO_SIDED|80.0|-3.69|-0.88||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.88|-3.69|0.019
91495948|NCT01059825|182863910|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.035|TWO_SIDED|80.0|-3.43|-0.59||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-3.43|0.035
91735538|NCT01576783|183364169|OTHER|The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.06
91735539|NCT01576783|183364170|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.51||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.51
91735540|NCT01576783|183364171|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.09||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.09
91735541|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.29
91735542|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.11
91735543|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.23
91735544|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.29
91735545|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.06
91735546|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.14||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.14
91735547|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.13||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.13
91735548|NCT01576783|183364172|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.16||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.16
91735549|NCT01576783|183364173|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.98|||||||Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.98
91735550|NCT01576783|183364173|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.67||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.67
91735551|NCT01576783|183364174|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.047||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.047
91735552|NCT01576783|183364175|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.2||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.20
91735553|NCT01576783|183364176|OTHER|Results are the comparison of proportion of those with a developmental condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.8|3.32||||||||3.32|0.80|
91495949|NCT01059825|182863910|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.3||||0.121|TWO_SIDED|80.0|-2.73|0.12||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.12|-2.73|0.121
91735554|NCT01576783|183364177|OTHER|Results are the comparison of proportion of those with a behavioral condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|4.5|||||TWO_SIDED|95.0|0.52|39.15||||||||39.15|0.52|
91735555|NCT03021486|183364226|OTHER|||||||0.71|||||||Wilcoxon Rank Sum Test|||||||0.71
91735556|NCT03021486|183364228|OTHER|||||||0.86|||||||Wilcoxon Rank Sum Test|||||||0.86
91735557|NCT03021486|183364229|OTHER|||||||0.12|||||||Two-tailed Fisher's exact test|||||||0.12
91735558|NCT03021486|183364230|OTHER|||||||0.007|||||||Two-tailed Fisher's exact test|||||||0.007
91735559|NCT03021486|183364231|OTHER|||||||0.83|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by caregiver||||0.83
91735560|NCT03021486|183364231|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by caregiver||||0.82
91735561|NCT03021486|183364232|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by nurse||||0.82
91735562|NCT03021486|183364232|OTHER|||||||0.91|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by nurse||||0.91
91735563|NCT03021486|183364233|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - frequency||||0.12
91735564|NCT03021486|183364233|OTHER|||||||0.07|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - frequency||||0.07
91495950|NCT01059825|182863910|SUPERIORITY_OR_OTHER||Difference in least squares means|0.29||||0.602|TWO_SIDED|80.0|-1.13|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-1.13|0.602
91495951|NCT01059825|182863911|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.045|TWO_SIDED|80.0|-3.86|-0.54||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.54|-3.86|0.045
91495952|NCT01059825|182863911|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.49||||0.126|TWO_SIDED|80.0|-3.16|0.18||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.18|-3.16|0.126
91495953|NCT01059825|182863911|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.03||||0.011|TWO_SIDED|80.0|-4.72|-1.34||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.34|-4.72|0.011
91495954|NCT01059825|182863911|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.99||||0.066|TWO_SIDED|80.0|-3.69|-0.3||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-3.69|0.066
91530435|NCT00318149|182937215|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01E Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.07|||||TWO_SIDED|98.75|0.79|1.44||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.44|0.79|
91735565|NCT03021486|183364233|OTHER|||||||0.051|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - frequency||||0.051
91735566|NCT03021486|183364233|OTHER|||||||0.048|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - frequency||||0.048
91735567|NCT03021486|183364233|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - frequency||||0.15
91735568|NCT03021486|183364233|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - frequency||||0.10
91735569|NCT03021486|183364233|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation- frequency||||0.15
91735570|NCT03021486|183364233|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - distress||||0.98
91735571|NCT03021486|183364233|OTHER|||||||0.93|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - distress||||0.93
91495955|NCT01059825|182863911|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.357|TWO_SIDED|80.0|-2.15|1.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.19|-2.15|0.357
91495956|NCT01059825|182863913|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.99||||0|TWO_SIDED|80.0|-28.29|-13.69||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.69|-28.29|0.000
91530436|NCT03088137|182937248|EQUIVALENCE|Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.|Mean Difference (Final Values)|0.546|STANDARD_DEVIATION|1.297||0.002|TWO_SIDED|95.0|-2.026|3.116|||Wilcoxon (Mann-Whitney)|||||3.116|-2.026|0.002
91530437|NCT03088137|182937249|SUPERIORITY||Mean Difference (Final Values)|0.709|STANDARD_DEVIATION|1.067||0.806|TWO_SIDED|95.0|-1.405|2.824|||Wilcoxon (Mann-Whitney)|||||2.824|-1.405|0.806
91735572|NCT03021486|183364233|OTHER|||||||0.08|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - distress||||0.08
91735573|NCT03021486|183364233|OTHER|||||||0.28|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - distress||||0.28
91735574|NCT03021486|183364233|OTHER|||||||0.83|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - distress||||0.83
91735575|NCT03021486|183364233|OTHER|||||||0.22|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - distress||||0.22
91735576|NCT03021486|183364233|OTHER|||||||0.75|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation - distress||||0.75
91735577|NCT03021486|183364234|OTHER|||||||0.09|||||||Wilcoxon Rank Sum Test|||||||0.09
91735578|NCT03021486|183364235|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in pain.||||0.02
91735579|NCT03021486|183364235|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Mean change in Fatigue.||||0.10
91735580|NCT03021486|183364235|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in Nausea.||||0.02
91735581|NCT03021486|183364235|OTHER|||||||0.97|||||||Wilcoxon Rank Sum Test|||Mean change in Depression.||||0.97
91735582|NCT03021486|183364235|OTHER|||||||0.03|||||||Wilcoxon Rank Sum Test|||Mean change in Anxiety.||||0.03
91735583|NCT03021486|183364235|OTHER|||||||0.68|||||||Wilcoxon Rank Sum Test|||Mean change in Drowsiness.||||0.68
91735584|NCT03021486|183364235|OTHER|||||||0.8|||||||Wilcoxon Rank Sum Test|||Mean change in Appetite.||||0.80
91735585|NCT03021486|183364235|OTHER|||||||0.45|||||||Wilcoxon Rank Sum Test|||Mean change in Feeling of well being.||||0.45
91735586|NCT03021486|183364235|OTHER|||||||0.16|||||||Wilcoxon Rank Sum Test|||Mean change in Shortness of breath.||||0.16
91735587|NCT03021486|183364235|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Mean change in Sleep.||||0.12
91735588|NCT04043286|183364237|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.18||0.009|TWO_SIDED|95.0|0.1|0.85|||Wilcoxon (Mann-Whitney)|The Shapiro-Wilk test assessed data normality, and paired t-tests or Wilcoxon tests were applied based on normality results.||The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.||0.85|0.10|0.009
91735589|NCT04043286|183364238|SUPERIORITY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.0000168|1.25|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||1.25|-0.0000168|0.049
91760040|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.52|0.13|
91495957|NCT01059825|182863913|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.82||||0|TWO_SIDED|80.0|-33.17|-18.47||P-value is one-sided.P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-18.47|-33.17|0.000
91735590|NCT04043286|183364239|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.15||0.053|TWO_SIDED|95.0|-0.0000522|0.75|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||0.75|-0.0000522|0.053
91735591|NCT01732536|183364241|SUPERIORITY|||||||0.1365|||||||ANCOVA|Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.1365
91735592|NCT01732536|183364241|SUPERIORITY|||||||0.0505||||||Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|ANCOVA|||The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).||||0.0505
91735593|NCT01732536|183364242|SUPERIORITY|||||||0.0985|||||||ANCOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||||||0.0985
91735594|NCT01732536|183364242|SUPERIORITY|||||||0.049|||||||ANOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)||||0.0490
91735595|NCT01732536|183364243|SUPERIORITY|||||||0.0099|||||||ANCOVA|||||||0.0099
91735596|NCT01732536|183364244|SUPERIORITY|||||||0.0162||||||P-value for change from baseline to 90 days not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0162
91735597|NCT01732536|183364244|SUPERIORITY|||||||0.0175||||||P-value for change from baseline to 6 months not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0175
91495958|NCT01059825|182863913|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.23||||0|TWO_SIDED|80.0|-41.64|-26.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-26.83|-41.64|0.000
91495959|NCT01059825|182863913|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.02||||0|TWO_SIDED|80.0|-39.49|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.49|0.000
91495960|NCT01059825|182863913|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.05||||0|TWO_SIDED|80.0|-27.39|-12.72||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.72|-27.39|0.000
91495961|NCT01059825|182863914|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.96||||0|TWO_SIDED|80.0|-28.58|-13.34||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.34|-28.58|0.000
91495962|NCT01059825|182863914|SUPERIORITY_OR_OTHER||Difference in least squares means|-21.57||||0|TWO_SIDED|80.0|-29.27|-13.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.86|-29.27|0.000
91495963|NCT01059825|182863914|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.54||||0|TWO_SIDED|80.0|-40.2|-24.88||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.88|-40.20|0.000
91735598|NCT01732536|183364245|SUPERIORITY|||||||0.0209||||||P-value not adjusted for multiplicity.|ANCOVA|Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0209
91735599|NCT03186638|183364262|SUPERIORITY|||||||0.7917|||||||ANCOVA|Adjusted for Baseline values||||||0.7917
91735600|NCT00524121|183364274|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon signed rank test|||||||0.011
91735601|NCT00524121|183364275|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Log Rank|||||||0.115
91735602|NCT00524121|183364276|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91735603|NCT00524121|183364277|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91530438|NCT03088137|182937250|SUPERIORITY||Mean Difference (Final Values)|0.218|STANDARD_DEVIATION|1.129||0.617|TWO_SIDED|95.0|-2.455|2.019|||Wilcoxon (Mann-Whitney)|||||2.019|-2.455|0.617
91735604|NCT00524121|183364278|SUPERIORITY_OR_OTHER|||||||0.5467|||||||Fisher Exact|||||||0.5467
91760041|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.12|0.27||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.12|
91760042|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.05|0.35||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.35|-0.05|
91760043|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.08|0.31||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.31|-0.08|
91735605|NCT02410772|183364281|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|1.0||||0.05|TWO_SIDED|95.0|-2.6|4.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||4.5|-2.6|0.05
91735606|NCT02410772|183364281|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|3.0||||0.05|TWO_SIDED|95.0|-0.6|6.6|||Cochran-Mantel-Haenszel|For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||6.6|-0.6|0.05
91735607|NCT02410772|183364282|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|2.0||||0.05|TWO_SIDED|95.0|-1.1|5.1||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||5.1|-1.1|0.05
91735608|NCT02410772|183364282|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|4.4||||0.05|TWO_SIDED|95.0|1.2|7.7||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||7.7|1.2|0.05
91759504|NCT02391363|183411755|SUPERIORITY|||||||0.45||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.45
91495964|NCT01059825|182863914|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.33||||0|TWO_SIDED|80.0|-30.05|-14.61||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-14.61|-30.05|0.000
91495965|NCT01059825|182863914|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.57||||0|TWO_SIDED|80.0|-28.19|-12.96||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.96|-28.19|0.000
91495966|NCT01059825|182863915|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.09||||0|TWO_SIDED|80.0|-29.16|-15.01||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.01|-29.16|0.000
91530439|NCT03088137|182937251|SUPERIORITY||Mean Difference (Final Values)|0.636|STANDARD_DEVIATION|1.19||0.445|TWO_SIDED|95.0|-2.995|1.723|||Wilcoxon (Mann-Whitney)|||||1.723|-2.995|0.445
91530440|NCT03088137|182937252|SUPERIORITY|||||||0.623|||||||ANOVA|||||||0.623
91735609|NCT02410772|183364283|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-0.6||||0.05|TWO_SIDED|95.0|-4.3|3.2||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||3.2|-4.3|0.05
91735610|NCT02410772|183364283|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-5.1||||0.05|TWO_SIDED|95.0|-8.7|-1.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||-1.5|-8.7|0.05
91735611|NCT02410772|183364288|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-2.45|4.63||||||||4.63|-2.45|
91735612|NCT02410772|183364288|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|4.12|||||TWO_SIDED|95.0|0.45|7.79||||||||7.79|0.45|
91735613|NCT02410772|183364289|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.05|||||TWO_SIDED|95.0|-2.01|4.11||||||||4.11|-2.01|
91735614|NCT02410772|183364289|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066)|Risk Difference (RD)|3.66|||||TWO_SIDED|95.0|0.42|6.9||||||||6.90|0.42|
91735615|NCT02410772|183364291|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.0|||||TWO_SIDED|95.0|-0.6|6.6||||||||6.6|-0.6|
91735616|NCT02410772|183364291|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|2.29|||||TWO_SIDED|95.0|-1.12|5.7||||||||5.70|-1.12|
91495967|NCT01059825|182863915|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.94||||0|TWO_SIDED|80.0|-35.06|-20.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-20.83|-35.06|0.000
91735617|NCT02410772|183364292|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|2.8|8.9||||||||8.9|2.8|
91735618|NCT02410772|183364292|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|0.5|6.3||||||||6.3|0.5|
91735619|NCT05528770|183364315|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|8.98||0.4291|TWO_SIDED|95.0|-3.8|8.3|||t-test, 2 sided|||||8.3|-3.8|0.4291
91495968|NCT01059825|182863915|SUPERIORITY_OR_OTHER||Difference in least squares means|-33.12||||0|TWO_SIDED|80.0|-40.29|-25.95||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-25.95|-40.29|0.000
91735620|NCT02493764|183364344|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was \< 10 percentage points.|Adjusted difference in ACM|-5.3|||<|0.001|TWO_SIDED|95.0|-11.9|1.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.2|-11.9|<0.001
91735621|NCT02493764|183364345|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 2-sided 95% CI for the difference in FCR (IMI/REL minus PIP/TAZ) was \> 12.5 percentage points.|Adjusted difference in FCR|5.0|||<|0.001|TWO_SIDED|95.0|-3.2|13.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in FCR||13.2|-3.2|<0.001
91735622|NCT02493764|183364346|OTHER|Difference in % with AE vs PIP/TAZ|Difference in % with AE|-1.7|||||TWO_SIDED|95.0|-7.7|4.3||||||||4.3|-7.7|
91735623|NCT02493764|183364347|OTHER|Difference in % discontinuing vs PIP/TAZ|Difference in % discontinuing|-2.5|||||TWO_SIDED|95.0|-7.1|1.8||||||||1.8|-7.1|
91735624|NCT02493764|183364348|OTHER||Adjusted difference in ACM|-3.5|||||TWO_SIDED|95.0|-10.9|3.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.6|-10.9|
91735625|NCT02493764|183364349|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% CI for the difference in mortality (IMI/REL minus PIP/TAZ) was ≥ 10 percentage points.|Adjusted difference in ACM|-4.6|||||TWO_SIDED|95.0|-11.0|1.7|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.7|-11.0|
91735626|NCT02493764|183364350|OTHER|Adjusted difference in ACM|Adjusted difference in ACM|-3.1|||||TWO_SIDED|95.0|-10.2|3.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.8|-10.2|
91735627|NCT02493764|183364351|OTHER|Difference in FCR|Adjusted difference in FCR|-1.7|||||TWO_SIDED|95.0|-11.3|7.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.8|-11.3|
91495969|NCT01059825|182863915|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.79||||0|TWO_SIDED|80.0|-39.02|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.02|0.000
91495970|NCT01059825|182863915|SUPERIORITY_OR_OTHER||Difference in least squares means|-23.17||||0|TWO_SIDED|80.0|-30.28|-16.07||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-16.07|-30.28|0.000
91530441|NCT03088137|182937253|SUPERIORITY||Mean Difference (Final Values)|14.9|STANDARD_DEVIATION|49.8||0.488|TWO_SIDED|95.0|-83.9|113.6|||Wilcoxon (Mann-Whitney)|||||113.6|-83.9|0.488
91530442|NCT03088137|182937254|SUPERIORITY||Mean Difference (Final Values)|0.018|STANDARD_DEVIATION|0.201||0.629|TWO_SIDED|95.0|-0.379|0.416|||Wilcoxon (Mann-Whitney)|||||0.416|-0.379|0.629
91530443|NCT03088137|182937255|SUPERIORITY|||||||0.644|||||||Wilcoxon (Mann-Whitney)|||||||0.644
91530444|NCT03088137|182937258|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.833|TWO_SIDED|95.0|-21.0|17.0|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||17.0|-21.0|0.833
91530445|NCT03088137|182937259|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.507|TWO_SIDED|95.0|-24.3|11.9|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||11.9|-24.3|0.507
91735628|NCT02493764|183364352|OTHER|Difference in FCR|Adjusted difference in FCR|-2.2|||||TWO_SIDED|95.0|-9.8|5.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||5.5|-9.8|
91735629|NCT02493764|183364353|OTHER|Difference in favorable clinical response|Adjusted difference in FCR|6.6|||||TWO_SIDED|95.0|-4.6|18.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||18.4|-4.6|
91735630|NCT02493764|183364354|OTHER|Difference in FCR|Adjusted difference in FCR|-0.4|||||TWO_SIDED|95.0|-8.1|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-8.1|
91530446|NCT05108649|182937262|OTHER|We treated the exposure as a four-level categorical variable with control messaging + NNC cigarettes as the control condition.||||||0.0008|||||||ANOVA|ANOVA compared scale scores across the conditions.||||||0.0008
91530447|NCT05108649|182937263|OTHER|||||||0.9804|||||||ANOVA|||||||0.9804
91530448|NCT05108649|182937264|OTHER|||||||0.6579|||||||ANOVA|||||||0.6579
91735631|NCT02493764|183364355|OTHER|Difference in FCR|Adjusted difference in FCR|-3.4|||||TWO_SIDED|95.0|-14.3|7.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.5|-14.3|
91530449|NCT05108649|182937265|OTHER|||||||0.4208|||||||ANOVA|||||||0.4208
91530450|NCT05108649|182937266|OTHER|||||||0.245|||||||Chi-squared|||||||0.245
91530451|NCT05108649|182937267|OTHER|||||||0.6396|||||||ANOVA|||||||0.6396
91530452|NCT05108649|182937268|OTHER|||||||0.0235|||||||ANOVA|||||||0.0235
91530453|NCT05108649|182937269|OTHER|||||||0.3564|||||||ANOVA|||||||0.3564
91530454|NCT05108649|182937270|OTHER|||||||0.6057|||||||ANOVA|||||||0.6057
91530455|NCT05108649|182937271|OTHER|||||||0.2304|||||||ANOVA|||||||0.2304
91530456|NCT00918749|182937280|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.598|STANDARD_ERROR_OF_MEAN|4.215||0.3946|TWO_SIDED|90.0|-10.568|3.372|||ANOVA|Fixed effects for treatment and center.||A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.||3.372|-10.568|0.3946
91530457|NCT00918749|182937280|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.197|STANDARD_ERROR_OF_MEAN|4.241||0.0045|TWO_SIDED|90.0|-19.208|-5.185|||ANOVA|Fixed effects for treatment and center.||||-5.185|-19.208|0.0045
91530458|NCT00918749|182937281|SUPERIORITY_OR_OTHER||LS Mean Difference|4.765|STANDARD_ERROR_OF_MEAN|4.952||0.3372|TWO_SIDED|90.0|-3.421|12.952|||ANOVA|Fixed effects for treatment and center.||||12.952|-3.421|0.3372
91530459|NCT00918749|182937281|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|4.966||0.965|TWO_SIDED|90.0|-8.427|7.991|||ANOVA|Fixed effects for treatment and center.||||7.991|-8.427|0.9650
91530460|NCT00918749|182937282|SUPERIORITY_OR_OTHER||LS Mean Difference|0.388|STANDARD_ERROR_OF_MEAN|4.269||0.9276|TWO_SIDED|90.0|-6.67|7.447|||ANOVA|Fixed effects for treatment and center.||||7.447|-6.670|0.9276
91530461|NCT00918749|182937282|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.787|STANDARD_ERROR_OF_MEAN|4.313||0.0133|TWO_SIDED|90.0|-17.917|-3.657|||ANOVA|Fixed effects for treatment and center.||||-3.657|-17.917|0.0133
91530462|NCT00918749|182937283|SUPERIORITY_OR_OTHER||LS Mean Difference|14.528|STANDARD_ERROR_OF_MEAN|9.28||0.1192|TWO_SIDED|90.0|-0.813|29.868|||ANOVA|Fixed effects for treatment and center.||||29.868|-0.813|0.1192
91530463|NCT00918749|182937283|SUPERIORITY_OR_OTHER||LS Mean Difference|14.215|STANDARD_ERROR_OF_MEAN|9.343||0.1298|TWO_SIDED|90.0|-1.23|29.659|||ANOVA|Fixed effects for treatment and center.||||29.659|-1.230|0.1298
91530464|NCT00918749|182937284|SUPERIORITY_OR_OTHER||LS Mean Difference|1.119|STANDARD_ERROR_OF_MEAN|6.093||0.8546|TWO_SIDED|90.0|-8.956|11.193|||ANOVA|Fixed effects for treatment and center.||||11.193|-8.956|0.8546
91735632|NCT02493764|183364356|OTHER|Difference in FCR|Adjusted difference in FCR|-3.7|||||TWO_SIDED|95.0|-13.6|6.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||6.4|-13.6|
91735633|NCT02493764|183364357|OTHER|Difference in FCR|Adjusted difference in FCR|3.5|||||TWO_SIDED|95.0|-4.6|11.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||11.6|-4.6|
91735634|NCT02493764|183364358|OTHER|Difference in FCR|Adjusted difference in FCR|0.5|||||TWO_SIDED|95.0|-6.3|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-6.3|
91735635|NCT02493764|183364359|OTHER|Difference in FCR|Adjusted difference in FCR|3.4|||||TWO_SIDED|95.0|-7.1|14.2|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||14.2|-7.1|
91735636|NCT02493764|183364360|OTHER|Difference in FCR|Adjusted difference in FCR|4.4|||||TWO_SIDED|95.0|-3.1|12.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||12.0|-3.1|
91735637|NCT02493764|183364361|OTHER|Difference in FCR|Adjusted difference in FCR|1.1|||||TWO_SIDED|95.0|-7.2|9.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||9.4|-7.2|
91735638|NCT02493764|183364362|OTHER|Difference in FMR|Adjusted difference in FMR|9.7|||||TWO_SIDED|95.0|1.6|17.9|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||17.9|1.6|
91735639|NCT02493764|183364363|OTHER|Difference in FMR|Adjusted difference in FMR|6.2|||||TWO_SIDED|95.0|-2.7|15.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||15.0|-2.7|
91735640|NCT02493764|183364364|OTHER|Difference in FMR|Adjusted difference in FMR|2.5|||||TWO_SIDED|95.0|-5.5|11.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||11.0|-5.5|
91735641|NCT02493764|183364365|OTHER|Difference in FMR|Adjusted difference in FMR|4.7|||||TWO_SIDED|95.0|-4.0|14.1|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||14.1|-4.0|
91735642|NCT04846231|183364373|SUPERIORITY||Mean Difference (Net)|35.22|||<|0.001|TWO_SIDED|95.0|29.13|41.32|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05. This belongs to the primary endpoint.||41.32|29.13|<0.001
91735643|NCT04846231|183364373|SUPERIORITY||Mean Difference (Net)|34.43|||<|0.001|TWO_SIDED|95.0|28.28|40.58|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||40.58|28.28|<0.001
91735644|NCT04846231|183364373|SUPERIORITY||Mean Difference (Net)|38.27|||<|0.001|TWO_SIDED|95.0|32.2|44.34|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||44.34|32.20|<0.001
91735645|NCT04846231|183364373|SUPERIORITY||Mean Difference (Net)|42.98|||<|0.001|TWO_SIDED|95.0|37.02|48.95|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||48.95|37.02|<0.001
91735646|NCT04846231|183364373|SUPERIORITY||Mean Difference (Final Values)|36.57|||<|0.001|TWO_SIDED|95.0|30.61|42.54|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||42.54|30.61|<0.001
91735647|NCT04846231|183364373|SUPERIORITY||Mean Difference (Net)|33.49|||<|0.001|TWO_SIDED|95.0|27.42|39.55|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||39.55|27.42|<0.001
91735648|NCT04846231|183364373|SUPERIORITY||Mean Difference (Net)|31.31|||<|0.001|TWO_SIDED|95.0|25.16|37.47|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||37.47|25.16|<0.001
91735649|NCT04846231|183364375|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
91530465|NCT00918749|182937284|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.393|STANDARD_ERROR_OF_MEAN|6.126||0.2291|TWO_SIDED|90.0|-17.522|2.737|||ANOVA|Fixed effects for treatment and center.||||2.737|-17.522|0.2291
91735650|NCT00265122|183364423|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||The P-Value is from a Cochran-Mantel-Haenszel (CMH) test stratified by the route of administration.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference between ustekinumab and placebo at a significant level of 0.05.||||0.337
91735651|NCT00265122|183364425|SUPERIORITY_OR_OTHER|||||||0.292||95.0||||The P-Value is from a CMH test stratified by the route of administration.|Cochran-Mantel-Haenszel|||||||0.292
91735652|NCT01276106|183364426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.175||0.044|TWO_SIDED|95.0|-0.7|-0.01||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||-0.01|-0.70|0.044
91735653|NCT01276106|183364426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.176||0.0979|TWO_SIDED|95.0|-0.64|0.05||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.05|-0.64|0.0979
91735654|NCT01276106|183364426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.174||0.2643|TWO_SIDED|95.0|-0.54|0.15||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.15|-0.54|0.2643
91735655|NCT00862940|183364431|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3||0.9754|TWO_SIDED|95.0|-2.6|2.52|||Mixed Models Analysis|||Linear mixed model relating direct change in brain volume (BBSI) to time and its interaction with treatment group. This model additionally includes a time-by-AChEI group interaction as a fixed effect.||2.52|-2.60|0.9754
91735656|NCT00862940|183364432|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.5|STANDARD_ERROR_OF_MEAN|17.52||0.842|TWO_SIDED|95.0|-38.04|31.04|||MMRM|||Mixed model repeated measurements (MMRM) with unstructured covariance including time, time-by-treatment, visit, pre-treatment HCV, and AChEI group.||31.04|-38.04|0.842
91735657|NCT00862940|183364433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|0.79||0.034|TWO_SIDED|95.0|0.13|3.23||The p-value represents the difference from placebo for COWAT at Week 52 (MMRM).|MMRM|||||3.23|0.13|0.034
91735658|NCT00862940|183364434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.46||0.602|TWO_SIDED|95.0|-0.67|1.15||The p-value represents the difference from placebo for MMSE at Week 52 (MMRM).|MMRM|||||1.15|-0.67|0.602
91735659|NCT00485173|183364435|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
91495971|NCT01059825|182863916|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.07||||0|TWO_SIDED|80.0|-28.87|-15.27||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.27|-28.87|0.000
91495972|NCT01059825|182863916|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.51||||0|TWO_SIDED|80.0|-35.35|-21.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-21.67|-35.35|0.000
91530466|NCT00918749|182937285|SUPERIORITY_OR_OTHER||LS Mean Difference|5.505|STANDARD_ERROR_OF_MEAN|9.046||0.5436|TWO_SIDED|90.0|-9.452|20.462|||ANOVA|Fixed effects for treatment and center.||||20.462|-9.452|0.5436
91735660|NCT00485173|183364435|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
91735661|NCT00485173|183364436|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
91735662|NCT00485173|183364436|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.002
91735663|NCT00485173|183364437|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.002
91735664|NCT00485173|183364438|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.|Regression, Logistic|||||||<0.001
91735665|NCT00485173|183364438|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.011
91735666|NCT00485173|183364439|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.063
91735667|NCT00485173|183364440|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
91735668|NCT00485173|183364440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
91735669|NCT00485173|183364441|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.031
91735670|NCT00485173|183364442|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.001
91735671|NCT00485173|183364442|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.414
91735672|NCT00485173|183364443|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.030
91735673|NCT00485173|183364444|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
91735674|NCT00485173|183364444|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.017
91495973|NCT01059825|182863916|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.4||||0|TWO_SIDED|80.0|-42.3|-28.51||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-28.51|-42.30|0.000
91530467|NCT00918749|182937285|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.914|STANDARD_ERROR_OF_MEAN|9.1||0.9201|TWO_SIDED|90.0|-15.959|14.132|||ANOVA|Fixed effects for treatment and center.||||14.132|-15.959|0.9201
91735675|NCT00485173|183364445|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.189
91735676|NCT00485173|183364446|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.003||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.003
91735677|NCT00485173|183364446|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.466
91735678|NCT00485173|183364447|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
91735679|NCT00485173|183364447|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.133
91735680|NCT00485173|183364448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
91735681|NCT00485173|183364449|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
91735682|NCT00485173|183364450|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.341
91495974|NCT01059825|182863916|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-41.76|-27.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-27.86|-41.76|0.000
91495975|NCT01059825|182863916|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.75||||0|TWO_SIDED|80.0|-29.58|-15.92||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.92|-29.58|0.000
91495976|NCT00106392|182863921|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-Values were not adjusted.|Wilcoxon (Mann-Whitney)|||A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.||||0.111
91495977|NCT00106392|182863922|SUPERIORITY_OR_OTHER|||||||0.453||95.0|||||Fisher Exact|||||||0.453
91495978|NCT00106392|182863923|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.790
91530468|NCT00918749|182937286|SUPERIORITY_OR_OTHER||LS Mean Difference|3.108|STANDARD_ERROR_OF_MEAN|4.052||0.444|TWO_SIDED|90.0|-3.59|9.807|||ANOVA|Fixed effects for treatment and center.||||9.807|-3.590|0.4440
91530469|NCT00918749|182937286|SUPERIORITY_OR_OTHER||LS Mean Difference|4.842|STANDARD_ERROR_OF_MEAN|4.063||0.2349|TWO_SIDED|90.0|-1.874|11.559|||ANOVA|Fixed effects for treatment and center.||||11.559|-1.874|0.2349
91530470|NCT00918749|182937287|SUPERIORITY_OR_OTHER||LS Mean Difference|4.966|STANDARD_ERROR_OF_MEAN|4.327||0.2527|TWO_SIDED|90.0|-2.189|12.12|||ANOVA|Fixed effects for treatment and center.||||12.120|-2.189|0.2527
91495979|NCT00106392|182863924|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||Fisher Exact|||||||0.099
91495980|NCT00106392|182863925|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.575
91495981|NCT00106392|182863926|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.879
91735683|NCT00485173|183364451|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.|Regression, Cox|||||||0.479
91495982|NCT02557698|182863936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.002|TWO_SIDED|95.0|-3.1|-0.8|||t-test, 2 sided|||H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groups||-0.8|-3.1|0.002
91495983|NCT02557698|182863937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.5|-1.2|||t-test, 2 sided|||||-1.2|-3.5|<0.001
91495984|NCT02557698|182863938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.024|TWO_SIDED|95.0|-3.2|-0.2|||t-test, 2 sided|||||-0.2|-3.2|0.024
91495985|NCT02557698|182863939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.017|TWO_SIDED|95.0|-3.1|-0.3|||t-test, 2 sided|||||-0.3|-3.1|0.017
91495986|NCT02557698|182863940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.964|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.964
91495987|NCT02557698|182863941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.025|TWO_SIDED|95.0|0.5|8.2|||t-test, 2 sided|||||8.2|0.5|0.025
91495988|NCT02557698|182863942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.458|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||||1.1|-2.5|0.458
91495989|NCT02557698|182863943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.066|TWO_SIDED|95.0|-3.5|0.1|||t-test, 2 sided|||||0.1|-3.5|0.066
91495990|NCT02557698|182863944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.171|TWO_SIDED|95.0|-13.7|2.5|||t-test, 2 sided|||||2.5|-13.7|0.171
91495991|NCT02557698|182863945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.059|TWO_SIDED|95.0|-15.3|0.3|||t-test, 2 sided|||||0.3|-15.3|0.059
91495992|NCT02557698|182863946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4|TWO_SIDED|95.0|-0.2|0.5|||t-test, 2 sided|||||0.5|-0.2|0.400
91495993|NCT02557698|182863947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.4|||t-test, 2 sided|||||0.4|-0.1|0.100
91495994|NCT02557698|182863948|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91495995|NCT02557698|182863949|SUPERIORITY_OR_OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
91495996|NCT02557698|182863950|SUPERIORITY_OR_OTHER|||||||0.822|||||||Wilcoxon (Mann-Whitney)|||||||0.822
91495997|NCT02557698|182863951|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
91495998|NCT02557698|182863952|SUPERIORITY_OR_OTHER|||||||0.259|||||||Wilcoxon (Mann-Whitney)|||||||0.259
91495999|NCT02557698|182863953|SUPERIORITY_OR_OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
91530471|NCT00918749|182937287|SUPERIORITY_OR_OTHER||LS Mean Difference|4.926|STANDARD_ERROR_OF_MEAN|4.371||0.2613|TWO_SIDED|90.0|-2.301|12.153|||ANOVA|Fixed effects for treatment and center.||||12.153|-2.301|0.2613
91530472|NCT00918749|182937288|SUPERIORITY_OR_OTHER||LS Mean Difference|1.269|STANDARD_ERROR_OF_MEAN|4.16||0.7606|TWO_SIDED|90.0|-5.609|8.148|||ANOVA|Fixed effects for treatment and center.||||8.148|-5.609|0.7606
91530473|NCT00918749|182937288|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.825|STANDARD_ERROR_OF_MEAN|4.185||0.5006|TWO_SIDED|90.0|-9.744|4.095|||ANOVA|Fixed effects for treatment and center.||||4.095|-9.744|0.5006
91530474|NCT03055832|182937324|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-3.82|3.56||||||||3.56|-3.82|
91530475|NCT03055832|182937325|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.97|1.16||||||||1.16|-0.97|
91496000|NCT02557698|182863954|SUPERIORITY_OR_OTHER|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
91735684|NCT00485173|183364452|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.|Regression, Logistic|||Statistical analysis at 24 months postoperation.||||<0.001
91735685|NCT04537650|183364453|SUPERIORITY||Odds Ratio (OR)|21.0|||<|0.001|TWO_SIDED|95.0|1.8|243.24|||Chi-squared|||||243.24|1.8|<0.001
91735686|NCT04537650|183364454|SUPERIORITY||Odds Ratio (OR)|45.0|||<|0.001|TWO_SIDED|95.0|4.15|487.5|||Chi-squared|||||487.5|4.15|<0.001
91735687|NCT00879398|183364461|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
91735688|NCT00879398|183364462|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
91735689|NCT00879398|183364463|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
91735690|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Statistical significant level: 0.05|Chi-squared|||Geriatric Status: \<65 years versus (vs) Geriatric Status: ≥65 years||||0.1319
91735691|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age Categories: \<50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.||||0.6010
91735692|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.0289||95.0||||Statistical significant level: 0.05|Chi-squared|||Male vs Female||||0.0289
91735693|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.3078||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Weight Categories: \<50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.||||0.3078
91735694|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.9614||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Height Categories: \<160 cm, 160 to 170 cm, and ≥170 cm.||||0.9614
91735695|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.0788||95.0||||Statistical significant level: 0.05|Fisher Exact|||Allergic History: Yes vs Allergic History: No||||0.0788
91735696|NCT00879398|183364465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Duration of Disease: \<1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.||||<0.0001
91735697|NCT00879398|183364465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Past OAB Treatment History: Yes vs Past OAB Treatment History: No||||<0.0001
91735698|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.1147||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Past Disease: Yes vs Medical History of Past Disease: No||||0.1147
91735699|NCT00879398|183364465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Present Disease: Yes vs Medical History of Present Disease: No||||<0.0001
91735700|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Kidney Disorder: Yes vs Kidney Disorder: No||||1.0000
91735701|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Liver Disorder: Yes vs Liver Disorder: No||||1.0000
91496001|NCT02557698|182863955|SUPERIORITY_OR_OTHER|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||||||0.759
91496002|NCT02557698|182863956|SUPERIORITY_OR_OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||||||0.831
91496003|NCT02557698|182863957|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
91735702|NCT00879398|183364465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Total Administration Period of Toviaz Subgroups: \<2 months, 2 to 4 months, and ≥4 months.||||<0.0001
91735703|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.0239||95.0||||Statistical significant level: 0.05|Fisher Exact|||Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, \>4 mg to \<8 mg, and 8 mg.||||0.0239
91735704|NCT00879398|183364465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Completion vs Discontinuation||||<0.0001
91735705|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.5889||95.0||||Statistical significant level: 0.05|Fisher Exact|||Total Administration Period \<274 days vs Total Administration Period ≥ 274 days||||0.5889
91735706|NCT00879398|183364465|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significant level: 0.05|Chi-squared|||Concurrent Medication: Yes vs Concurrent Medication: No||||0.0010
91735707|NCT00829244|183364466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.037|TWO_SIDED|95.0|-3.3|-0.1|||ANOVA|||The null hypothesis was that the difference between the mean number of oocytes \[CONSORT calculator dosing - Standard dosing\] was less than or equal to \[=\<\] (-3). The alternate hypothesis was that the difference was greater than \[\>\] (-3).||-0.1|-3.3|0.037
91735708|NCT00829244|183364467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-511.37|STANDARD_ERROR_OF_MEAN|64.52|<|0.001|TWO_SIDED|95.0|-638.78|-383.96|||ANOVA|||||-383.96|-638.78|<0.001
91735709|NCT00829244|183364468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.6|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-53.75|-37.46|||ANOVA|||||-37.46|-53.75|<0.001
91735710|NCT00829244|183364469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.933|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.933
91735711|NCT00829244|183364471|SUPERIORITY_OR_OTHER||Percent difference|3.6|||||TWO_SIDED|95.0|-11.0|18.2||||||||18.2|-11.0|
91735712|NCT00829244|183364473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|6.6||0.926|TWO_SIDED|95.0|-12.3|13.6|||ANOVA|||||13.6|-12.3|0.926
91735713|NCT00829244|183364475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.78||0.235|TWO_SIDED|95.0|-0.61|2.47|||ANOVA|||||2.47|-0.61|0.235
91735714|NCT00829244|183364476|SUPERIORITY_OR_OTHER||Percent difference|0.6|||||TWO_SIDED|95.0|-13.5|14.6||||||||14.6|-13.5|
91735715|NCT05047627|183364496|OTHER||Differences in slopes|0.76||||0.755|TWO_SIDED|95.0|-4.14|5.66|||Robust linear mixed models|||||5.66|-4.14|.755
91735716|NCT05047627|183364497|OTHER||Differences in slopes|1.38||||0.713|TWO_SIDED|95.0|-6.15|8.91|||Robust linear mixed models|||||8.91|-6.15|0.713
91735717|NCT05047627|183364498|OTHER||Differences in slopes|1.03||||0.323|TWO_SIDED|95.0|-1.02|3.09|||Robust linear mixed models|||||3.09|-1.02|0.323
91735718|NCT05047627|183364499|OTHER||Differences in slopes|-0.33||||0.692|TWO_SIDED|95.0|-1.95|1.3|||Robust linear mixed models|||||1.30|-1.95|.692
91735719|NCT05047627|183364500|OTHER||Differences in slopes|-2.92||||0.1|TWO_SIDED|95.0|-6.41|0.58|||Robust linear mixed models|||||0.58|-6.41|0.1
91496004|NCT02557698|182863958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.07|TWO_SIDED|95.0|-0.3|7.4|||t-test, 2 sided|||||7.4|-0.3|0.07
91496005|NCT02557698|182863959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.029|TWO_SIDED|95.0|0.4|7.7|||t-test, 2 sided|||||7.7|0.4|0.029
91496006|NCT02557698|182863960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.325|TWO_SIDED|95.0|-1.8|0.6|||t-test, 2 sided|||||0.6|-1.8|0.325
91735720|NCT04251533|183364503|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.92|2.41|||Regression, Cox|||||2.41|0.92|
91735721|NCT06378008|183364517|SUPERIORITY||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.98|-1.62|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||-1.62|-1.98|<0.0001
91496007|NCT02557698|182863961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.365|TWO_SIDED|95.0|-2.6|0.9|||t-test, 2 sided|||||0.9|-2.6|0.365
91496008|NCT02557698|182863962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.143|TWO_SIDED|95.0|-8.5|1.3|||t-test, 2 sided|||||1.3|-8.5|0.143
91496009|NCT02557698|182863963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.662|TWO_SIDED|95.0|-6.5|4.2|||t-test, 2 sided|||||4.2|-6.5|0.662
91496010|NCT02557698|182863964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.326|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||||0.1|-0.4|0.326
91496011|NCT02557698|182863965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.687|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.687
91496012|NCT01737944|182863966|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A - SC injection with the Vibex MTX device and Treatment B - SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.24|||||TWO_SIDED|90.0|92.33|100.31||||||||100.31|92.33|
91496013|NCT01737944|182863966|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.28|||||TWO_SIDED|90.0|97.17|105.56||||||||105.56|97.17|
91496014|NCT01737944|182863967|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.22|||||TWO_SIDED|90.0|92.32|100.28||||||||100.28|92.32|
91496015|NCT01737944|182863967|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.14|||||TWO_SIDED|90.0|97.06|105.4||||||||105.40|97.06|
91496016|NCT01737944|182863968|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.76|||||TWO_SIDED|90.0|87.93|106.47||||||||106.47|87.93|
91496017|NCT01737944|182863968|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|89.79|||||TWO_SIDED|90.0|81.61|98.78||||||||98.78|81.61|
91496018|NCT02495168|182863981|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance (ANCOVA) model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Referece LS Mean Ratio|101.9|||||TWO_SIDED|90.0|92.7|111.9|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||111.9|92.7|
91496019|NCT02495168|182863982|SUPERIORITY||LS Mean Difference|2.334|||<|0.0001|TWO_SIDED|95.0|1.673|2.996||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||2.996|1.673|<0.0001
91496020|NCT02495168|182863982|SUPERIORITY||LS Mean Difference|2.606|||<|0.0001|TWO_SIDED|95.0|1.939|3.273||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||3.273|1.939|<0.0001
91496021|NCT02495168|182863983|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Reference LS Mean Ratio|99.8|||||TWO_SIDED|90.0|87.0|114.5|||||Fieller's formula was applied to calculate the 90% CI for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||114.5|87.0|
91496022|NCT02495168|182863984|SUPERIORITY||LS Mean Difference|0.159|||<|0.0001|TWO_SIDED|95.0|0.093|0.226||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||0.226|0.093|<0.0001
91735722|NCT06378008|183364518|SUPERIORITY||Adjusted Mean Difference|52.87|STANDARD_ERROR_OF_MEAN|2.428|<|0.0001|TWO_SIDED|95.0|48.08|57.65|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||57.65|48.08|<0.0001
91530476|NCT03055832|182937326|OTHER|A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.||||||0.12|||||||Fisher Exact|||||||0.12
91530477|NCT03055832|182937327|NON_INFERIORITY|A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.89|||TWO_SIDED|95.0|-8.75|2.59||||||All questions||2.59|-8.75|
91530478|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.064|-0.026|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M3||-0.026|-0.064|
91530479|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.025|0.02|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.020|-0.025|
91530480|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.033|0.013|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M9||0.013|-0.033|
91530481|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.044|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||0.004|-0.044|
91530482|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.048|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M15||0.003|-0.048|
91530483|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.016||||90.0|-0.05|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M18||0.004|-0.050|
91530484|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.047|0.007|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M21||0.007|-0.047|
91530485|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.054|0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.002|-0.054|
91530486|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.021|0.034|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.034|-0.021|
91530487|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.018||||90.0|-0.016|0.044|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.044|-0.016|
91530488|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.002|0.055|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.055|-0.002|
91530489|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.04|0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.032|-0.040|
91530490|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.07|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.004|-0.070|
91530491|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.077|-0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||-0.002|-0.077|
91530492|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M9||0.003|-0.075|
91530493|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.058|0.022|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.022|-0.058|
91530494|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.034|0.048|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M15||0.048|-0.034|
91530495|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.055|0.033|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.033|-0.055|
91530496|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.058|0.029|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M21||0.029|-0.058|
91530497|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.061|0.03|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.030|-0.061|
91530498|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.044|0.043|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M27||0.043|-0.044|
91530499|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.051|0.04|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.040|-0.051|
91530500|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.042|0.058|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M33||0.058|-0.042|
91530501|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.032||||90.0|-0.03|0.077|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.077|-0.030|
91530502|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.042|0.035|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.035|-0.042|
91530503|NCT00136916|182937334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.023|0.062|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||0.062|-0.023|
91735723|NCT06378008|183364519|SUPERIORITY||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||-0.08|-0.29|0.0005
91735724|NCT06378008|183364519|SUPERIORITY||Adjusted Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.73|-0.49|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||-0.49|-0.73|<0.0001
91530504|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.058||||90.0|-0.215|-0.023|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M3||-0.023|-0.215|
91735725|NCT06378008|183364519|SUPERIORITY||Adjusted Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.41|-1.04|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||-1.04|-1.41|<0.0001
91735726|NCT06378008|183364519|SUPERIORITY||Adjusted Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.74|-1.38|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||-1.38|-1.74|<0.0001
91735727|NCT06378008|183364520|SUPERIORITY||Adjusted Mean Difference|7.14|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|5.75|8.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||8.53|5.75|<0.0001
91735728|NCT06378008|183364520|SUPERIORITY||Adjusted Mean Difference|14.4|STANDARD_ERROR_OF_MEAN|1.112|<|0.0001|TWO_SIDED|95.0|12.2|16.59|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||16.59|12.20|<0.0001
91735729|NCT06378008|183364520|SUPERIORITY||Adjusted Mean Difference|25.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|22.67|28.93|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||28.93|22.67|<0.0001
91530505|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.067||||90.0|-0.133|0.087|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M6||0.087|-0.133|
91530506|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.069||||90.0|-0.104|0.124|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M9||0.124|-0.104|
91530507|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.033|0.214|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M12||0.214|-0.033|
91530508|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.081||||90.0|-0.081|0.185|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M15||0.185|-0.081|
91735730|NCT06378008|183364520|SUPERIORITY||Adjusted Mean Difference|40.99|STANDARD_ERROR_OF_MEAN|2.254|<|0.0001|TWO_SIDED|95.0|36.55|45.43|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||45.43|36.55|<0.0001
91735731|NCT06378008|183364521|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.219||0.3489|TWO_SIDED|95.0|-0.64|0.23|||Mixed Model with Repeated Measures||Adjusted Mean Difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.23|-0.64|0.3489
91530509|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.087||||90.0|-0.054|0.234|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M18||0.234|-0.054|
91530510|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.085||||90.0|-0.073|0.208|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M21||0.208|-0.073|
91530511|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.096||||90.0|-0.058|0.257|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M24||0.257|-0.058|
91530512|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.09||||90.0|-0.143|0.154|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M3||0.154|-0.143|
91530513|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.094||||90.0|-0.119|0.19|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M6||0.190|-0.119|
91530514|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.2|0.161|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M1||0.161|-0.200|
91530515|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.101|0.263|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M3||0.263|-0.101|
91530516|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.108||||90.0|-0.038|0.32|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M6||0.320|-0.038|
91530517|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.116||||90.0|-0.041|0.342|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M9||0.342|-0.041|
91530518|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.118||||90.0|-0.09|0.298|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M12||0.298|-0.090|
91530519|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.125||||90.0|-0.132|0.279|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M15||0.279|-0.132|
91530520|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.111|0.284|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M18||0.284|-0.111|
91530521|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.141|0.27|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M21||0.270|-0.141|
91496023|NCT02495168|182863984|SUPERIORITY||LS Mean Difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.099|0.229||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||0.229|0.099|<0.0001
91496024|NCT03247530|182863992|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.61||0.0004|TWO_SIDED|95.0|-8.9|-2.6|||Mixed Models for Repeated Measures|||||-2.6|-8.9|0.0004
91496025|NCT03247530|182863992|SUPERIORITY||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-10.0|-3.8|||Mixed Models for Repeated Measures|||||-3.8|-10.0|<0.0001
91735732|NCT06378008|183364521|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.267||0.0876|TWO_SIDED|95.0|-0.98|0.07|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.07|-0.98|0.0876
91735733|NCT06378008|183364521|SUPERIORITY||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.252||0.9108|TWO_SIDED|95.0|-0.47|0.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.52|-0.47|0.9108
91735734|NCT06378008|183364521|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.281||0.4854|TWO_SIDED|95.0|-0.75|0.36|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.36|-0.75|0.4854
91735735|NCT06378008|183364521|SUPERIORITY||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.261||0.8309|TWO_SIDED|95.0|-0.46|0.57|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.57|-0.46|0.8309
91735736|NCT06378008|183364521|SUPERIORITY||Adjusted Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.297||0.05|TWO_SIDED|95.0|-1.17|0.0|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||-0.00|-1.17|0.0500
91735737|NCT06378008|183364522|SUPERIORITY||Adjusted Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|3.859||0.5565|TWO_SIDED|95.0|-9.88|5.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||5.33|-9.88|0.5565
91735738|NCT06378008|183364522|SUPERIORITY||Adjusted Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|4.715||0.2078|TWO_SIDED|95.0|-15.25|3.34|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||3.34|-15.25|0.2078
91735739|NCT06378008|183364523|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.588||0.5597|TWO_SIDED|95.0|-1.5|0.82|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.82|-1.50|0.5597
91735740|NCT06378008|183364523|SUPERIORITY||Adjusted Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.705||0.4627|TWO_SIDED|95.0|-1.91|0.87|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.87|-1.91|0.4627
91735741|NCT06378008|183364524|SUPERIORITY||Adjusted Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.583||0.3|TWO_SIDED|95.0|-4.77|1.48|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.48|-4.77|0.3000
91735742|NCT06378008|183364524|SUPERIORITY||Adjusted Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.958||0.1974|TWO_SIDED|95.0|-6.39|1.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.33|-6.39|0.1974
91735743|NCT06378008|183364525|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.679||0.9203|TWO_SIDED|95.0|-1.27|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.27|0.9203
91735744|NCT06378008|183364525|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.717||0.2489|TWO_SIDED|95.0|-2.24|0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.58|-2.24|0.2489
91735745|NCT06378008|183364526|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|1.09||0.8496|TWO_SIDED|95.0|-2.36|1.94|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.94|-2.36|0.8496
91735746|NCT06378008|183364526|SUPERIORITY||Adjusted Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|1.226||0.1596|TWO_SIDED|95.0|-4.15|0.69|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.69|-4.15|0.1596
91735747|NCT06378008|183364527|SUPERIORITY||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.697||0.9577|TWO_SIDED|95.0|-1.34|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.34|0.9577
91735748|NCT06378008|183364527|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.748||0.8261|TWO_SIDED|95.0|-1.64|1.31|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.31|-1.64|0.8261
91496026|NCT03247530|182863993|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.7|0.0020
91496027|NCT03247530|182863993|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.8|<0.0001
91496028|NCT03247530|182863994|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.16||0.0003|TWO_SIDED|95.0|-6.5|-1.9|||ANCOVA|||||-1.9|-6.5|0.0003
91496029|NCT03247530|182863994|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.15||0.0002|TWO_SIDED|95.0|-6.6|-2.1|||ANCOVA|||||-2.1|-6.6|0.0002
91496030|NCT03247530|182863995|SUPERIORITY||Least Square Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.047||0.0019|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA|||||-0.05|-0.24|0.0019
91496031|NCT03247530|182863995|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.002|TWO_SIDED|95.0|-0.26|-0.08|||ANCOVA|||||-0.08|-0.26|0.0020
91496032|NCT03247530|182863996|SUPERIORITY||Risk Difference (RD)|14.5||||0.0063|TWO_SIDED|95.0|4.3|24.6|||Regression, Logistic|||||24.6|4.3|0.0063
91496033|NCT03247530|182863996|SUPERIORITY||Risk Difference (RD)|21.5|||<|0.0001|TWO_SIDED|95.0|11.3|31.6|||Regression, Logistic|||||31.6|11.3|<0.0001
91496034|NCT03247530|182863997|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9974|TWO_SIDED|95.0|-4.5|4.5|||ANCOVA|||||4.5|-4.5|0.9974
91496035|NCT03247530|182863997|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.26||0.4557|TWO_SIDED|95.0|-6.1|2.7|||ANCOVA|||||2.7|-6.1|0.4557
91496036|NCT03247530|182863998|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.85||0.0006|TWO_SIDED|95.0|-4.6|-1.2|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.2|-4.6|0.0006
91735749|NCT06378008|183364528|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.8895|TWO_SIDED|95.0|-0.19|0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.16|-0.19|0.8895
91735750|NCT06378008|183364528|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.101||0.8083|TWO_SIDED|95.0|-0.17|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.22|-0.17|0.8083
91496037|NCT03247530|182863998|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.2|-1.9|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.9|-5.2|<0.0001
91735751|NCT06378008|183364529|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.351||0.7362|TWO_SIDED|95.0|-0.57|0.81|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.81|-0.57|0.7362
91735752|NCT06378008|183364529|SUPERIORITY||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.39||0.5568|TWO_SIDED|95.0|-1.0|0.54|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.54|-1.00|0.5568
91735753|NCT02302222|183364550|SUPERIORITY||Risk Difference (RD)|0.113||||0.1981|TWO_SIDED|95.0|-0.016|0.243|||Fisher Exact|||||0.243|-0.016|0.1981
91735754|NCT03110562|183364555|SUPERIORITY||Hazard Ratio (HR)|0.702||||0.0075|TWO_SIDED|95.0|0.5279|0.9335||One Sided P-value|Stratified Log-rank Test|Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||0.9335|0.5279|0.0075
91735755|NCT03110562|183364556|SUPERIORITY||Odds Ratio (OR)|1.9626||||0.0012|TWO_SIDED|95.0|1.2641|3.0471||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||3.0471|1.2641|0.0012
91496038|NCT03247530|182863998|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.83||0.0026|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.9|-4.1|0.0026
91496039|NCT03247530|182863998|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.8|-1.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.7|-4.8|<0.0001
91496040|NCT03247530|182863999|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.1292|TWO_SIDED|95.0|-4.2|0.5|||ANCOVA|||||0.5|-4.2|0.1292
91496041|NCT03247530|182863999|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.19||0.3447|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.3447
91496042|NCT03247530|182864000|SUPERIORITY|||||||0.0005|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.0005
91496043|NCT03247530|182864000|SUPERIORITY|||||||0.0212|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0212
91496044|NCT03247530|182864000|SUPERIORITY|||||||0.0115|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0115
91496045|NCT03247530|182864000|SUPERIORITY|||||||0.0027|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0027
91496046|NCT03247530|182864000|SUPERIORITY|||||||0.0066|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0066
91496047|NCT03247530|182864000|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0065
91496048|NCT03247530|182864000|SUPERIORITY|||||||0.5826|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.5826
91496049|NCT03247530|182864000|SUPERIORITY|||||||0.0099|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0099
91496050|NCT03247530|182864000|SUPERIORITY|||||||0.0225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0225
91496051|NCT03247530|182864000|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0008
91496052|NCT03247530|182864000|SUPERIORITY|||||||0.002|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0020
91496053|NCT03247530|182864000|SUPERIORITY|||||||0.0002|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0002
91496054|NCT04786990|182864006|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91496055|NCT04786990|182864006|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91496056|NCT04786990|182864007|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91735756|NCT03110562|183364557|SUPERIORITY||Odds Ratio (OR)|1.6594||||0.0082|TWO_SIDED|95.0|1.0993|2.5049||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||2.5049|1.0993|0.0082
91735757|NCT03110562|183364558|SUPERIORITY||Odds Ratio (OR)|0.5042||||0.0013|TWO_SIDED|95.0|0.3216|0.7906||One Sided P-value|Cochran-Mantel-Haenszel||Stratified by Prior PI therapies (Yes or No), Number of prior anti-MM regimens (1 or \>1), and R-ISS stage at study entry (R-ISS Stage III versus R-ISS Stage I or II).|||0.7906|0.3216|0.0013
91735758|NCT03110562|183364559|SUPERIORITY||Hazard Ratio (HR)|0.8764||||0.2152|TWO_SIDED|95.0|0.6313|1.2168||One Sided P-value|Stratified log-rank test|Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||1.2168|0.6313|0.2152
91735759|NCT02769481|183364594|NON_INFERIORITY|A 95% CI was to be calculated to estimate the range of values in which the treatment difference was likely to lie. If the 95% CI fell below the specified non inferiority margin of 0.35%, the non inferiority of bexagliflozin treatment to glimepiride treatment would be demonstrated and the null hypothesis would be rejected.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.21|0.11|||||A lower value represents a better treatment effect.|The null hypothesis for the primary endpoint was that the change in HbA1c from baseline to week 60 in the bexagliflozin arm would be greater than change in the glimepiride arm by greater than 0.35%.||0.11|-0.21|
91496057|NCT04786990|182864007|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91496058|NCT04786990|182864009|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91496059|NCT04786990|182864009|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0002
91496060|NCT04786990|182864010|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91735760|NCT02769481|183364595|SUPERIORITY||Difference of LS Means|-4.31|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.52||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-3.52|-5.10|< 0.0001
91735761|NCT02769481|183364596|SUPERIORITY||Difference of LS Means|-6.53||||0.0008|TWO_SIDED|95.0|-10.56|-2.51||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-2.51|-10.56|0.0008
91735762|NCT02769481|183364597|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.28||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline HbA1c, background treatment, eGFR at baseline, treatment as a fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over glimepiride.|||0.28|0.05|< 0.0001
91735763|NCT02769481|183364598|SUPERIORITY|Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% confidence interval is less than 0|Difference of LS Means|-0.05|||||TWO_SIDED|95.0|-0.21|0.11||||||||0.11|-0.21|
91496061|NCT04786990|182864010|OTHER||||||<|0.0001||||||The p-value generated for the comparison between time points for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed. There is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91496062|NCT04786990|182864011|OTHER|||||||0.0685||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0685
91496063|NCT04786990|182864011|OTHER|||||||0.2575||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.2575
91496064|NCT04786990|182864012|OTHER|||||||0.0832||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0832
91530522|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.123||||90.0|-0.156|0.249|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M24||0.249|-0.156|
91735764|NCT04604431|183364615|SUPERIORITY||Odds Ratio (OR)|14.1|||<|0.001|TWO_SIDED|95.0|6.9|29.1|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for low-risk infants.||29.1|6.9|<0.001
91735765|NCT04604431|183364615|SUPERIORITY||Odds Ratio (OR)|3.1||||0.034|TWO_SIDED|95.0|1.1|8.8|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for high-risk infants.||8.8|1.1|0.034
91496065|NCT04786990|182864012|OTHER|||||||0.3715||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.3715
91496066|NCT04786990|182864013|OTHER|||||||0.0042||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||0.0042
91496067|NCT04786990|182864013|OTHER|||||||0.0019||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0019
91496068|NCT04786990|182864014|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||<0.0001
91496069|NCT04786990|182864014|OTHER|||||||0.0025||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.0025
91530523|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.138|0.272|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M27||0.272|-0.138|
91735766|NCT00643279|183364620|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|91.5|||||ONE_SIDED|95.0|88.7||||||||||88.7|
91735767|NCT00643279|183364621|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|100.0|||||ONE_SIDED|95.0|98.9||||||||||98.9|
91735768|NCT01334918|183364629|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Predefined noninferiority criterion: If the lower boundary of the 95% CI was within 0.15 of 0.78, MDCT would be determined to be noninferior to SPECT.|Agreement rate|0.87|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|0.77|0.97||||||Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.||0.97|0.77|
91735769|NCT01334918|183364634|SUPERIORITY_OR_OTHER_LEGACY||Specificity|0.95|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.9|0.99||||||Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.||0.99|0.90|
91496070|NCT04786990|182864015|OTHER|||||||0.0161||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0161
91496071|NCT04786990|182864015|OTHER|||||||0.0122||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0122
91496072|NCT04786990|182864016|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91496073|NCT04786990|182864016|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91530524|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.132||||90.0|-0.171|0.264|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M30||0.264|-0.171|
91530525|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.824|STANDARD_ERROR_OF_MEAN|8.319||||90.0|-3.92|23.569|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M33||23.569|-3.920|
91530526|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.197||||90.0|-0.316|0.337|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M36||0.337|-0.316|
91735770|NCT01334918|183364634|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|0.77|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|0.54|1.0||||||Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.||1.00|0.54|
91735771|NCT02777086|183364663|SUPERIORITY||||||<|0.001|||||||ANCOVA|||3-month outcome measures were compared between the StaySafe and Comparison groups controlling for the baseline measure using generalized linear models.||||<.001
91735772|NCT01819272|183364705|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-9.0||||0.067|TWO_SIDED|95.0|-21.0|1.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||1.0|-21.0|0.0670
91735773|NCT01819272|183364705|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-14.0||||0.0057|TWO_SIDED|95.0|-22.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.0|-22.0|0.0057
91735774|NCT01819272|183364705|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.1095|TWO_SIDED|95.0|-25.0|3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||3.0|-25.0|0.1095
91735775|NCT01819272|183364705|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.0097|TWO_SIDED|95.0|-23.0|-3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-3.0|-23.0|0.0097
91735776|NCT01819272|183364705|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-28.0|||<|0.0001|TWO_SIDED|95.0|-42.0|-17.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-17.0|-42.0|<0.0001
91735777|NCT01819272|183364706|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0226|TWO_SIDED|95.0|-208.0|-16.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-16.00|-208.0|0.0226
91735778|NCT01819272|183364706|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0068|TWO_SIDED|95.0|-180.0|-32.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-32.00|-180.0|0.0068
91735779|NCT01819272|183364706|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-152.0||||0.0071|TWO_SIDED|95.0|-252.0|-42.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-42.00|-252.0|0.0071
91735780|NCT01819272|183364706|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-101.0||||0.0405|TWO_SIDED|95.0|-208.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.00|-208.0|0.0405
91735781|NCT01819272|183364706|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-224.0|||<|0.0001|TWO_SIDED|95.0|-334.0|-118.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-118.0|-334.0|<.0001
91735782|NCT01819272|183364707|SUPERIORITY_OR_OTHER||LS Mean|-0.48||||0.01|TWO_SIDED|95.0|-0.85|-0.12|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.12|-0.85|0.0100
91735783|NCT01819272|183364707|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0153|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.09|-0.81|0.0153
91735784|NCT01819272|183364707|SUPERIORITY_OR_OTHER||LS Mean|-0.35||||0.0611|TWO_SIDED|95.0|-0.71|0.02|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||0.02|-0.71|0.0611
91735785|NCT01819272|183364707|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0188|TWO_SIDED|95.0|-0.83|-0.08|||ANCOVA|Factor for treatment and baseline HbA1c as acovariate||||-0.08|-0.83|0.0188
91735786|NCT01819272|183364707|SUPERIORITY_OR_OTHER||LS Mean|-0.67||||0.0006|TWO_SIDED|95.0|-1.04|-0.29|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.29|-1.04|0.0006
91735787|NCT01246960|183364756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.886|TWO_SIDED|95.0|0.69|1.37|||Stratified Log Rank|||||1.37|0.69|0.886
91735788|NCT01246960|183364757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.712|TWO_SIDED|95.0|0.73|1.58|||Stratified Log Rank|||||1.58|0.73|0.712
91735789|NCT01246960|183364760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.516|TWO_SIDED|95.0|0.59|1.3|||Stratified Log Rank|||||1.30|0.59|0.516
91735790|NCT01409096|183364763|SUPERIORITY_OR_OTHER|||||||0.9084|TWO_SIDED||||||ANCOVA|||Baseline HRSD scores used as covariate.||||0.9084
91735791|NCT01409096|183364764|SUPERIORITY_OR_OTHER|||||||0.5187|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.5187
91735792|NCT01409096|183364765|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||ANOVA|||Baseline YMRS used as a covariate.||||0.6060
91735793|NCT01409096|183364766|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||ANCOVA|||Baseline HRSA used as a covariate.||||0.5110
91735794|NCT03376516|183364799|OTHER|||||||0.9593||||||P-Value for patients aged 1-\<6 years (N=5)|ANOVA|||||||0.9593
91735795|NCT03376516|183364799|OTHER|||||||0.3752||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.3752
91735796|NCT03376516|183364799|OTHER|||||||0.8273||||||P-Value for total PK population (N=10)|ANOVA|||||||0.8273
91735797|NCT03376516|183364800|OTHER|P-Value for patients aged 1-\<6 years (N=5)||||||0.8536|||||||ANOVA|||||||0.8536
91735798|NCT03376516|183364800|OTHER|||||||0.9791||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.9791
91735799|NCT03376516|183364800|OTHER|||||||0.9791||||||P-Value for total PK population (N=10)|ANOVA|||||||0.9791
91735800|NCT03376516|183364802|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|30.85||||||||30.85|0|
91735801|NCT01444911|183364810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||||||0.89
91735802|NCT01766102|183364816|OTHER|||||||0.716|||||||t-test, 2 sided|||H0: Procedure time is not significantly different based on mammography type used||||0.716
91735803|NCT01766102|183364816|OTHER|||||||0.676|||||||t-test, 2 sided|||H0: Operating room time is not significantly different based on mammography type used||||0.676
91735804|NCT00508521|183364824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.75|STANDARD_ERROR_OF_MEAN|0.47871||0.0001|TWO_SIDED|95.0|-22.27348|-19.22652|||t-test, 2 sided|||This was a feasibility study. Pre and post treatment analysis was performed for the study participants.||-19.22652|-22.27348|.0001
91735805|NCT01622296|183364825|SUPERIORITY_OR_OTHER|||||||0.23||||||Significant at p\<0.05|t-test, 2 sided|||Inferior Alveolar nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.23
91735806|NCT01622296|183364825|SUPERIORITY_OR_OTHER|||||||0.57||||||Significant at p\<0.05|t-test, 2 sided|||Long buccal nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.57
91735807|NCT05093621|183364828|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Mortality at 1 year||||1.000
91735808|NCT05093621|183364829|SUPERIORITY|||||||0.729|||||||t-test, 2 sided|||||||0.729
91735809|NCT05093621|183364830|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.650
91735810|NCT05093621|183364831|SUPERIORITY|||||||0.873|||||||t-test, 2 sided|||||||0.873
91735811|NCT01664624|183364832|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|5.82||0.388|TWO_SIDED|95.0|-16.9|6.7||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and alogliptin alone.||6.7|-16.9|0.388
91735812|NCT01664624|183364832|SUPERIORITY_OR_OTHER||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|11.1|34.3||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||34.3|11.1|<0.001
91496074|NCT04786990|182864017|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0002
91735813|NCT01664624|183364832|SUPERIORITY_OR_OTHER||LS Mean Difference|28.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|17.1|40.5||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||40.5|17.1|<0.001
91735814|NCT01152307|183364863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|STANDARD_DEVIATION|1.6||0.01|TWO_SIDED|95.0|0.76|6.09|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||6.09|0.76|0.01
91735815|NCT02369536|183364873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
91735816|NCT02369536|183364876|SUPERIORITY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
91735817|NCT00949533|183364885|SUPERIORITY_OR_OTHER|||||||0.825|||||||Pearson Chi-Square|||||||0.825
91735818|NCT00949533|183364886|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||> 0.05
91735819|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Cough: statistical difference between 2 groups was based on chi-squared test.||||1.000
91735820|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||0.284|||||||Chi-squared|||Rhinorrhea: statistical difference between 2 groups was based on chi-squared test.||||0.284
91735821|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sore throat: statistical difference between 2 groups was based on fisher-exact test.||||1.000
91735822|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Shortness of breath: statistical difference between 2 groups was based on fisher-exact test.||||1.000
91496075|NCT04786990|182864017|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91735823|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||0.487|||||||Fisher Exact|||Diarrhea: statistical difference between 2 groups was based on fisher-exact test.||||0.487
91735824|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||Headache: statistical difference between 2 groups was based on fisher-exact test.||||0.593
91735825|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test.||||1.000
91735826|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Vomiting: statistical difference between 2 groups was based on fisher-exact test.||||1.000
91530527|NCT00136916|182937340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.163||||90.0|-0.245|0.292|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext FU M3||0.292|-0.245|
91735827|NCT00949533|183364887|SUPERIORITY_OR_OTHER|||||||0.106|||||||Fisher Exact|||Other: statistical difference between 2 groups was based on fisher-exact test.||||0.106
91735828|NCT01493089|183364889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.563||95.0|||||Regression, Cox|||||||0.563
91735829|NCT01493089|183364890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903||||0.712||95.0|||||Regression, Cox|||||||0.712
91735830|NCT01493089|183364891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.457|TWO_SIDED|95.0|||||Regression, Cox|||||||0.457
91496076|NCT04786990|182864018|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91530528|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.39|STANDARD_ERROR_OF_MEAN|4.054||||90.0|-19.07|-5.71|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M3||-5.710|-19.07|
91530529|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.21|STANDARD_ERROR_OF_MEAN|4.795||||90.0|-22.11|-6.312|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M6||-6.312|-22.11|
91735831|NCT01493089|183364892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.625||95.0|-9.7|15.3|||Regression, Cox|||Sustained partial response||15.3|-9.7|0.625
91735832|NCT01493089|183364892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.755|TWO_SIDED|95.0|-15.0|10.6|||Regression, Cox|||Sustained response||10.6|-15.0|0.755
91735833|NCT01493089|183364892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8||||0.194|TWO_SIDED|95.0|-3.6|17.2|||Regression, Cox|||Sustained total relief||17.2|-3.6|0.194
91735834|NCT01493089|183364893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.501|TWO_SIDED|95.0|-15.0|7.0|||Regression, Cox|||Sustained partial response||7.0|-15.0|0.501
91735835|NCT01493089|183364893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.518|TWO_SIDED|95.0|-17.6|8.2|||Regression, Cox|||Sustained response||8.2|-17.6|0.518
91735836|NCT01493089|183364893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.794|TWO_SIDED|95.0|-11.2|13.1|||Regression, Cox|||Sustained total relief||13.1|-11.2|0.794
91735837|NCT01493089|183364894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.494|TWO_SIDED|95.0|-6.3|11.2|||Regression, Cox|||Sustained partial response||11.2|-6.3|0.494
91735838|NCT01493089|183364894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.751|TWO_SIDED|95.0|-14.7|9.1|||Regression, Cox|||Sustained response||9.1|-14.7|0.751
91735839|NCT01493089|183364894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.69|TWO_SIDED|95.0|-16.4|9.6|||Regression, Cox|||Sustained total relief||9.6|-16.4|0.690
91735840|NCT02164864|183364909|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.63||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.||0.63|0.42|<0.0001
91735841|NCT02164864|183364909|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.88||P-values for non-inferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority||0.88|0.58|<.0001
91735842|NCT02164864|183364909|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.42|0.63||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.||0.63|0.42|<0.001
91735843|NCT02164864|183364909|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.88||unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Regression, Cox|Wald 2-sided p-value from (unstratified) Cox proportional hazards model||A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|0.88|0.58|0.0020
91735844|NCT02164864|183364910|OTHER||Hazard Ratio (HR)|0.99||||0.9862|TWO_SIDED|95.0|0.25|3.95||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||3.95|0.25|0.9862
91735845|NCT02164864|183364910|OTHER|Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Hazard Ratio (HR)|1.59||||0.5277|TWO_SIDED|95.0|0.38|6.64|||Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||6.64|0.38|0.5277
91735846|NCT02164864|183364911|OTHER||Hazard Ratio (HR)|1.06||||0.8853|TWO_SIDED|95.0|0.5|2.25||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.25|0.50|0.8853
91735847|NCT02164864|183364911|OTHER||Hazard Ratio (HR)|0.49||||0.238|TWO_SIDED|95.0|0.15|1.61||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.61|0.15|0.2380
91735848|NCT02164864|183364912|OTHER||Hazard Ratio (HR)|1.17||||0.5252|TWO_SIDED|95.0|0.72|1.88||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.88|0.72|0.5252
91735849|NCT02164864|183364912|OTHER||Hazard Ratio (HR)|0.84||||0.567|TWO_SIDED|95.0|0.47|1.51||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.47|0.5670
91735850|NCT02164864|183364913|OTHER||Hazard Ratio (HR)|1.12||||0.5579|TWO_SIDED|95.0|0.76|1.65||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.65|0.76|0.5579
91496077|NCT04786990|182864018|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91735851|NCT02164864|183364913|OTHER||Hazard Ratio (HR)|0.83||||0.4414|TWO_SIDED|95.0|0.51|1.34||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.34|0.51|0.4414
91735852|NCT02164864|183364914|OTHER|Wald 2-sided p-value from (stratified) Cox proportional hazards model|Hazard Ratio (HR)|1.51||||0.0861|TWO_SIDED|95.0|0.94|2.41|||Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.41|0.94|0.0861
91735853|NCT02164864|183364914|OTHER||Hazard Ratio (HR)|1.16||||0.6144|TWO_SIDED|95.0|0.66|2.04||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.04|0.66|0.6144
91496078|NCT04786990|182864019|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
91496079|NCT04786990|182864020|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
91496080|NCT04786990|182864021|OTHER|||||||0.0016||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0016
91496081|NCT04786990|182864022|OTHER|||||||0.89||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.8900
91496082|NCT04786990|182864023|OTHER|||||||0.3269||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3269
91496083|NCT04786990|182864024|OTHER|||||||0.5085||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5085
91496084|NCT04786990|182864025|OTHER|||||||0.3484||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3484
91496085|NCT04786990|182864026|OTHER|||||||0.4385||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.4385
91496086|NCT04786990|182864027|OTHER|||||||0.5073||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5073
91496087|NCT04786990|182864028|OTHER|||||||0.9119||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.9119
91496088|NCT04786990|182864029|OTHER|||||||0.014||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0140
91496089|NCT04786990|182864030|OTHER|||||||0.1542||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.1542
91496090|NCT04786990|182864031|OTHER|||||||0.0086||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0086
91496091|NCT04786990|182864032|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91496092|NCT04786990|182864032|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91496093|NCT04786990|182864033|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
91496094|NCT04786990|182864033|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
91496095|NCT04786990|182864034|OTHER|||||||0.5582||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 4; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5582
91496096|NCT04786990|182864035|OTHER|||||||0.5061||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 8; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5061
91496097|NCT02846779|182864064|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.75|1.03||||||||1.03|0.75|
91496098|NCT02846779|182864064|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.77|1.06||||||||1.06|0.77|
91496099|NCT02846779|182864065|SUPERIORITY||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.34|0.05||||||||0.05|-0.34|
91496100|NCT02846779|182864065|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.43|-0.06||||||||-0.06|-0.43|
91496101|NCT02846779|182864066|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
91496102|NCT02846779|182864066|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.92|1.06||||||||1.06|0.92|
91496103|NCT02846779|182864067|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.02||||||||1.02|0.97|
91496104|NCT02846779|182864067|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.96|1.0||||||||1.00|0.96|
91496105|NCT02846779|182864068|SUPERIORITY||Risk Ratio (RR)|1.38|||||TWO_SIDED|95.0|1.24|1.53||||||||1.53|1.24|
91735854|NCT02164864|183364915|OTHER||Hazard Ratio (HR)|1.3||||0.4803|TWO_SIDED|95.0|0.63|2.67||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.67|0.63|0.4803
91735855|NCT02164864|183364915|OTHER||Hazard Ratio (HR)|1.09||||0.8537|TWO_SIDED|95.0|0.42|2.83||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.83|0.42|0.8537
91735856|NCT02164864|183364916|OTHER||Hazard Ratio (HR)|0.94||||0.9388|TWO_SIDED|95.0|0.19|4.66||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.66|0.19|0.9388
91735857|NCT02164864|183364916|OTHER||Hazard Ratio (HR)|0.3||||0.303|TWO_SIDED|95.0|0.03|2.93||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.93|0.03|0.3030
91735858|NCT02164864|183364917|OTHER||Hazard Ratio (HR)|1.86||||0.1546|TWO_SIDED|95.0|0.79|4.4||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.40|0.79|0.1546
91735859|NCT02164864|183364917|OTHER||Hazard Ratio (HR)|0.99||||0.9789|TWO_SIDED|95.0|0.35|2.81||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.81|0.35|0.9789
91735860|NCT02164864|183364918|OTHER||Hazard Ratio (HR)|1.34||||0.0484|TWO_SIDED|95.0|1.0|1.79||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.79|1.00|0.0484
91735861|NCT02164864|183364918|OTHER||Hazard Ratio (HR)|1.03||||0.8903|TWO_SIDED|95.0|0.71|1.47||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.47|0.71|0.8903
91735862|NCT02164864|183364919|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.17||||0.1128|TWO_SIDED|95.0|0.9|1.53||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.||1.53|0.90|0.1128
91735863|NCT02164864|183364919|OTHER||Hazard Ratio (HR)|1.3||||0.072|TWO_SIDED|95.0|0.98|1.73||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.73|0.98|0.0720
91735864|NCT02164864|183364919|OTHER||Hazard Ratio (HR)|0.97||||0.875|TWO_SIDED|95.0|0.68|1.39||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.39|0.68|0.8750
91735865|NCT02164864|183364920|OTHER||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.79|1.51||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.79|0.6080
91735866|NCT02164864|183364920|OTHER||Hazard Ratio (HR)|0.96||||0.8348|TWO_SIDED|95.0|0.65|1.41||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.41|0.65|0.8348
91735867|NCT02164864|183364921|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.04||||0.0047|TWO_SIDED|95.0|0.84|1.29||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.||1.29|0.84|0.0047
91530530|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|4.92||||90.0|-19.07|-2.852|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M12||-2.852|-19.07|
91530531|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56|STANDARD_ERROR_OF_MEAN|5.052||||90.0|-20.89|-4.232|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M24||-4.232|-20.89|
91530532|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.83|STANDARD_ERROR_OF_MEAN|21.867||||90.0|-80.69|47.019|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M3||47.019|-80.69|
91530533|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.578|STANDARD_ERROR_OF_MEAN|7.173||||90.0|-9.257|14.412|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M6||14.412|-9.257|
91496106|NCT02846779|182864068|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.85|1.07||||||||1.07|0.85|
91496107|NCT02846779|182864069|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|1.06|1.41||||||||1.41|1.06|
91496108|NCT02846779|182864069|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.99|1.32||||||||1.32|0.99|
91496109|NCT00887978|182864073|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.089|TWO_SIDED|95.0|-2.0|22.0|||non-parametric ANCOVA|||Using an allocation ratio of 1:1 between UT-15C SR and placebo, a fixed sample size of approximately 266 subjects would provide at least 90% power at a significance level of 0.05 (two-sided hypothesis) to detect a 30 meter between-treatment difference in the change from Baseline in distance traversed during the 6-Minute Walk, assuming a standard deviation of 75 meters. A total sample size of approximately 300 subjects was determined to account for discontinuations during the enrollment period.||22.0|-2.0|0.089
91496110|NCT00887978|182864074|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91496111|NCT00887978|182864075|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) Estimate|0.0||||0.22|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum test|||||0.0|-1.0|0.22
91496112|NCT00887978|182864076|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.43|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for the 26 UT-15C subjects and 17 placebo subjects without values reported at Week 16.|Wilcoxon rank sum test|||||0.0|0.0|0.43
91496113|NCT00887978|182864078|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.3|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon rank sum test|||||1.0|0.0|0.30
91496114|NCT00887978|182864081|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|14.0||||0.058|TWO_SIDED|95.0|0.0|28.0|||ANCOVA|||||28.0|0.0|0.058
91496115|NCT00887978|182864082|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|15.0||||0.054|TWO_SIDED|95.0|-1.0|29.0|||ANCOVA|||||29.0|-1.0|0.054
91496116|NCT00887978|182864084|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|4.0||||0.674|TWO_SIDED|95.0|-16.0|24.0|||ANCOVA|||||24.0|-16.0|0.674
91496117|NCT00887978|182864085|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|28.0||||0.059|TWO_SIDED|95.0|1.0|59.0|||ANCOVA|||||59.0|1.0|0.059
91496118|NCT00887978|182864086|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|10.0||||0.22|TWO_SIDED|95.0|-10.0|31.0|||ANCOVA|||||31.0|-10.0|0.22
91496119|NCT00887978|182864087|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|3.0||||0.99|TWO_SIDED|95.0|-23.0|28.0|||ANCOVA|||||28.0|-23.0|0.99
91496120|NCT00887978|182864088|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||0.84||95.0|-25.0|22.0|||ANCOVA|||||22.0|-25.0|0.84
91496121|NCT05353985|182864091|SUPERIORITY||LS Mean Difference|0.017|||=|0.847|TWO_SIDED|95.0|-0.162|0.197||P-value was based on a MMRM analysis with treatment group, week, treatment-by-week interaction, \& the randomization stratification factors as fixed effects \& baseline CDSD GI symptom severity scores as covariates, and participant as a random effect.|MMRM|||||0.197|-0.162|=0.847
91496122|NCT05353985|182864092|SUPERIORITY||LS Mean Difference|-0.331|||<|0.001|TWO_SIDED|95.0|-0.481|-0.181||P-value was based on a ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline Vh:Cd as covariates.|ANCOVA|||||-0.181|-0.481|<0.001
91496123|NCT00524368|182864095|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.|Difference in proportion of response|0.0019|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.054|0.092|||Regression, Logistic|The model includes treatment as factor and baseline viral load (log10) as covariate.|Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.|Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.||0.092|-0.054|<0.001
91496124|NCT00524368|182864096|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.|Difference in proportion of response|0.007|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.06|0.075|||Regression, Logistic|A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.|Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)|||0.075|-0.060|<0.001
91496125|NCT00524368|182864097|SUPERIORITY_OR_OTHER||Difference between least square means|-0.003|STANDARD_ERROR_OF_MEAN|0.094||0.977|TWO_SIDED|95.0|-0.188|0.182|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.|||0.182|-0.188|0.977
91496126|NCT00524368|182864098|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.094||0.917|TWO_SIDED|95.0|0.824|1.191|||Cox proportional hazards|Including treatment as fixed factor and baseline plasma viral load as a covariate||||1.191|0.824|0.917
91496127|NCT00524368|182864099|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.945|STANDARD_ERROR_OF_MEAN|0.154||0.716|TWO_SIDED|95.0|0.699|1.279|||Regression, Cox|Including baseline log10 viral load as covariate||||1.279|0.699|0.716
91496128|NCT00524368|182864100|SUPERIORITY_OR_OTHER||Difference in least square means|-0.03|STANDARD_ERROR_OF_MEAN|0.072||0.711|TWO_SIDED|95.0|-0.169|0.115|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)|||0.115|-0.169|0.711
91530534|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|STANDARD_ERROR_OF_MEAN|6.007||||90.0|-19.37|0.45|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M1||0.450|-19.37|
91530535|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.481|STANDARD_ERROR_OF_MEAN|6.446||||90.0|-20.11|1.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M3||1.153|-20.11|
91530536|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.76|STANDARD_ERROR_OF_MEAN|6.785||||90.0|-21.95|0.438|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M6||0.438|-21.95|
91530537|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.827|STANDARD_ERROR_OF_MEAN|6.154||||90.0|-16.98|3.328|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M9||3.328|-16.98|
91530538|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.287|STANDARD_ERROR_OF_MEAN|7.192||||90.0|-19.15|4.579|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M12||4.579|-19.15|
91530539|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.848|STANDARD_ERROR_OF_MEAN|7.219||||90.0|-13.76|10.066|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M15||10.066|-13.76|
91530540|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.022|STANDARD_ERROR_OF_MEAN|7.156||||90.0|-20.83|2.79|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M18||2.790|-20.83|
91530541|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.078|STANDARD_ERROR_OF_MEAN|7.217||||90.0|-18.99|4.834|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M21||4.834|-18.99|
91530542|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|STANDARD_ERROR_OF_MEAN|7.329||||90.0|-24.63|-0.429|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M24||-0.429|-24.63|
91530543|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.07|STANDARD_ERROR_OF_MEAN|6.895||||90.0|-30.45|-7.685|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M27||-7.685|-30.45|
91735868|NCT02164864|183364921|OTHER||Hazard Ratio (HR)|1.13||||0.3002|TWO_SIDED|95.0|0.9|1.43||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.43|0.90|0.3002
91735869|NCT02164864|183364921|OTHER||Hazard Ratio (HR)|0.89||||0.4432|TWO_SIDED|95.0|0.67|1.19||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.19|0.67|0.4432
91735870|NCT00261833|183364927|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.618||||0.029|TWO_SIDED|95.0|-0.024|1.261||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval \[CI\] being greater than zero) will indicate superiority of Zemaira compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.261|-0.024|0.029
91760044|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|0.28|0.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.73|0.28|
91530544|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|STANDARD_ERROR_OF_MEAN|7.223||||90.0|-15.15|8.705|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M30||8.705|-15.15|
91530545|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|7.625||||90.0|-21.09|4.107|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M33||4.107|-21.09|
91530546|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.88|STANDARD_ERROR_OF_MEAN|8.906||||90.0|-36.66|-7.105|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M36||-7.105|-36.66|
91530547|NCT00136916|182937341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.673|STANDARD_ERROR_OF_MEAN|8.77||||90.0|-19.16|9.812|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext FU M3||9.812|-19.16|
91530548|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|STANDARD_ERROR_OF_MEAN|0.217||||90.0|-0.416|0.299|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M3||0.299|-0.416|
91530549|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.735|STANDARD_ERROR_OF_MEAN|0.297||||90.0|-1.224|-0.246|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M6||-0.246|-1.224|
91530550|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.642|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.251|-0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M12||-0.032|-1.251|
91530551|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.355|STANDARD_ERROR_OF_MEAN|0.464||||90.0|-2.12|-0.589|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M24||-0.589|-2.120|
91530552|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.303|STANDARD_ERROR_OF_MEAN|0.475||||90.0|-2.086|-0.52|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M3||-0.520|-2.086|
91530553|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.557|STANDARD_ERROR_OF_MEAN|0.596||||90.0|-2.539|-0.575|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M6||-0.575|-2.539|
91496129|NCT00524368|182864101|SUPERIORITY_OR_OTHER||Difference in least square means|-5.95|STANDARD_ERROR_OF_MEAN|10.26||0.562|TWO_SIDED|95.0|-26.09|14.2|||ANCOVA|The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||14.20|-26.09|0.562
91496130|NCT00524368|182864102|SUPERIORITY_OR_OTHER||Difference in least square means|0.55|STANDARD_ERROR_OF_MEAN|1.79||0.761|TWO_SIDED|95.0|-2.97|4.06|||ANCOVA|Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||4.06|-2.97|0.761
91496131|NCT00040937|182864109|SUPERIORITY_OR_OTHER||4-yr survival (%)|64.0|||||TWO_SIDED|95.0|55.0|74.0|||Kaplan and Meier|||The study was designed to have 82% power for detecting a 50% improvement in survival from a median of 4 years, as observed in SWOG S9321.||74|55|
91496132|NCT00410046|182864156|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Admissions to hospital||||1.0
91496133|NCT00410046|182864156|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||Therapeutic warm bath sessions||||0.23
91496134|NCT00410046|182864156|SUPERIORITY_OR_OTHER|||||||0.567|||||||Fisher Exact|||Physiotherapist visits||||0.567
91496135|NCT00410046|182864156|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Out-patient physician visit||||0.475
91496136|NCT00410046|182864157|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANCOVA|One-way ANCOVA, baseline was a covariate.||Inpatient hospitalization days per patient||||0.628
91496137|NCT00410046|182864157|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|||Therapeutic warm bath sessions per patient||||0.045
91496138|NCT00410046|182864157|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANCOVA|||Physiotherapist visits per patient||||0.361
91496139|NCT00410046|182864157|SUPERIORITY_OR_OTHER|||||||0.816|||||||ANCOVA|||Out-patient physician visit per patient||||0.816
91496140|NCT00410046|182864158|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Analysis completed for patients with sick leave during the past 12 months||||1.00
91496141|NCT00410046|182864159|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANCOVA|||||||0.906
91496142|NCT00410046|182864164|SUPERIORITY_OR_OTHER|||||||0.743||||||Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks|Fisher Exact|||||||0.743
91530554|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.904|STANDARD_ERROR_OF_MEAN|0.603||||90.0|-1.898|0.09|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M1||0.090|-1.898|
91530555|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.573||||90.0|-2.225|-0.334|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M3||-0.334|-2.225|
91496143|NCT00410046|182864164|SUPERIORITY_OR_OTHER|||||||0.362||||||Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks|Fisher Exact|||Comparison of percentages||||0.362
91496144|NCT00410046|182864164|SUPERIORITY_OR_OTHER|||||||0.005||||||Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks|Fisher Exact|||||||0.005
91496145|NCT00410046|182864164|SUPERIORITY_OR_OTHER|||||||0.091||||||Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks|Fisher Exact|||||||0.091
91496146|NCT00410046|182864165|SUPERIORITY_OR_OTHER|||||||0.576||||||Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment|Fisher Exact|||||||0.576
91496147|NCT03010254|182864170|SUPERIORITY||Least Squares Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.021|<|0.001|TWO_SIDED|95.0|-0.18|-0.097||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.097|-0.180|<0.001
91496148|NCT03010254|182864172|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.037|STANDARD_ERROR_OF_MEAN|0.0115|||ONE_SIDED|97.5||0.059|||||Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.|||0.059||
91496149|NCT03010254|182864173|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.0216|<|0.001|TWO_SIDED|95.0|-0.133|-0.048||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.048|-0.133|<0.001
91496150|NCT03010254|182864174|OTHER||Mean difference in depth of focus|0.52|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Mean difference in depth of focus (DFT015 - SN60WF)|||||
91496151|NCT03010254|182864175|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.0551|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|Without glare|||-0.287|
91496152|NCT03010254|182864175|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.181|STANDARD_ERROR_OF_MEAN|0.0541|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|With glare|||-0.287|
91496153|NCT03010254|182864176|SUPERIORITY||Difference in percentage|20.2|||||TWO_SIDED|95.0|8.77|31.04|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||31.04|8.77|
91496154|NCT03010254|182864177|SUPERIORITY||Percent difference|21.7|||||TWO_SIDED|95.0|7.92|35.06|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||35.06|7.92|
91496155|NCT02715076|182864178|OTHER||||||<|0.05|||||||mixed-effects model|||||||<0.05
91496156|NCT01404325|182864179|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91496157|NCT01075204|182864208|SUPERIORITY_OR_OTHER|||||||0.334||95.0|||||Chi-squared|9 degrees of freedom.||Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).||||0.334
91496158|NCT02310568|182864227|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.01||0.784|TWO_SIDED|90.0|-2.8|3.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.9|-2.8|0.784
91496159|NCT02310568|182864227|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.94||0.184|TWO_SIDED|90.0|-0.6|5.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||5.8|-0.6|0.184
91530556|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.834|STANDARD_ERROR_OF_MEAN|0.652||||90.0|-1.909|0.241|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M6||0.241|-1.909|
91530557|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.001|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-2.08|0.078|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M9||0.078|-2.080|
91735871|NCT00261833|183364927|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.74||||0.017|TWO_SIDED|95.0|0.059|1.42||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.420|0.059|0.017
91735872|NCT00261833|183364927|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.478||||0.09|TWO_SIDED|95.0|-0.223|1.18||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.180|-0.223|0.090
91735873|NCT00261833|183364931|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.04||||0.058|TWO_SIDED|95.0|-0.26|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.26|0.058
91735874|NCT00261833|183364931|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.32||||0.028|TWO_SIDED|95.0|-0.03|2.67||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects at a 1-sided significance level of 0.025.||2.67|-0.03|0.028
91735875|NCT00261833|183364931|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.89||||0.115|TWO_SIDED|95.0|-0.57|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.57|0.115
91735876|NCT00474903|183364972|SUPERIORITY_OR_OTHER|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||||||0.0955
91735877|NCT00474903|183364972|SUPERIORITY_OR_OTHER|||||||0.0204|||||||Wilcoxon (Mann-Whitney)|||||||0.0204
91735878|NCT02519842|183364998|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-7.6|27.9|||||Mean difference in percentage of participants who experienced at least 1 tier 2 AE and received fosaprepitant regimen compared with participants who received control regimen.|||27.9|-7.6|
91735879|NCT02519842|183364999|OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-5.1|17.8|||||Mean difference in percentage of participants who discontinued due to an AE and received fosaprepitant regimen compared with participants who received control regimen.|||17.8|-5.1|
91735880|NCT00859833|183365003|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.7||0.3617|TWO_SIDED|95.0|-0.6041|0.2241|||t-test, 2 sided|||Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.||0.2241|-0.6041|0.3617
91735881|NCT01561976|183365010|OTHER||Ratio|108.94||||0.1413|TWO_SIDED|95.0|101.01|117.5|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||117.50|101.01|0.1413
91735882|NCT01561976|183365010|OTHER||Ratio|107.24||||0.1413|TWO_SIDED|95.0|99.37|115.73|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||115.73|99.37|0.1413
91735883|NCT01561976|183365011|OTHER||Ratio|116.5||||0.0171|TWO_SIDED|95.0|106.91|126.95|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||126.95|106.91|0.0171
91735884|NCT01561976|183365011|OTHER||Ratio|107.24||||0.0171|TWO_SIDED|95.0|98.35|116.94|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||116.94|98.35|0.0171
91530558|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.316|STANDARD_ERROR_OF_MEAN|0.676||||90.0|-2.431|-0.2|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M12||-0.200|-2.431|
91735885|NCT01561976|183365012|OTHER||Ratio|116.87||||0.0169|TWO_SIDED|95.0|107.07|127.57|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||127.57|107.07|0.0169
91496160|NCT02310568|182864227|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.22||0.36|TWO_SIDED|90.0|-5.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||1.6|-5.7|0.360
91496161|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.36||0.708|TWO_SIDED|90.0|-3.2|5.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.0|-3.2|0.708
91496162|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.36||0.646|TWO_SIDED|90.0|-5.2|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.0|-5.2|0.646
91496163|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.09||0.352|TWO_SIDED|90.0|-1.6|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.6|-1.6|0.352
91735886|NCT01561976|183365012|OTHER||Ratio|107.38||||0.0169|TWO_SIDED|95.0|98.3|117.29|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||117.29|98.30|0.0169
91735887|NCT01463527|183365018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.17|0.57||||||Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.||0.57|0.17|
91735888|NCT01463527|183365019|SUPERIORITY|||||||0.3|||||||GEE (Generalized Estimating Equation)|||||||0.30
91735889|NCT01977222|183365027|OTHER|||||||0.1673|||||||t-test, 2 sided|||||||0.1673
91496164|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.99||0.495|TWO_SIDED|90.0|-3.1|7.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.3|-3.1|0.495
91496165|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.99||0.422|TWO_SIDED|90.0|-2.7|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-2.7|0.422
91735890|NCT01977222|183365028|OTHER|||||||0.5745|||||||t-test, 2 sided|||||||0.5745
91496166|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.65||0.889|TWO_SIDED|90.0|-5.0|4.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.2|-5.0|0.889
91496167|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|2.71||0.324||90.0|-2.0|7.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.4|-2.0|0.324
91496168|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.69||0.939|TWO_SIDED|90.0|-4.5|4.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.9|-4.5|0.939
91530559|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.512|STANDARD_ERROR_OF_MEAN|0.696||||90.0|-2.661|-0.363|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M15||-0.363|-2.661|
91530560|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.313|STANDARD_ERROR_OF_MEAN|0.916||||90.0|-2.824|0.198|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M18||0.198|-2.824|
91735891|NCT01977222|183365029|OTHER|||||||0.511|||||||t-test, 2 sided|||||||.511
91496169|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.42||0.308|TWO_SIDED|90.0|-1.7|6.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||6.7|-1.7|0.308
91735892|NCT01977222|183365030|OTHER|||||||0.776|||||||t-test, 2 sided|||||||0.776
91735893|NCT01977222|183365031|OTHER|||||||0.5374|||||||t-test, 2 sided|||||||0.5374
91735894|NCT01977222|183365032|OTHER|||||||0.3385|||||||t-test, 2 sided|||||||0.3385
91735895|NCT01977222|183365033|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
91735896|NCT01977222|183365034|OTHER|||||||0.1183|||||||t-test, 2 sided|||||||0.1183
91735897|NCT03648385|183365039|SUPERIORITY|||||||0.83|||||||generalized estimating equations (GEE) w|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.83
91735898|NCT03648385|183365039|SUPERIORITY|||||||0.56|||||||generalized estimating equations (GEE) w|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.56
91735899|NCT03648385|183365040|SUPERIORITY|||||||0.08|||||||generalized estimating equations (GEE) w|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.08
91735900|NCT03648385|183365040|SUPERIORITY|||||||0.03|||||||generalized estimating equations (GEE)|with sandwich estimation to correct for model misspecification.||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.03
91735901|NCT03648385|183365041|SUPERIORITY|||||||0.047|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.047
91735902|NCT03648385|183365041|SUPERIORITY|||||||0.052|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.052
91735903|NCT03648385|183365042|SUPERIORITY|||||||0.044|||||||generalized estimating equations (GEE) w|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.044
91496170|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|3.92||0.846|TWO_SIDED|90.0|-6.0|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-6.0|0.846
91496171|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|3.89||0.449|TWO_SIDED|90.0|-9.8|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.7|-9.8|0.449
91496172|NCT02310568|182864229|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|3.51||0.295|TWO_SIDED|90.0|-2.3|9.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||9.9|-2.3|0.295
91496173|NCT02310568|182864231|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.72||0.514|TWO_SIDED|90.0|-4.0|1.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-4.0|0.514
91496174|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.65||0.302|TWO_SIDED|90.0|-4.5|1.0|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.0|-4.5|0.302
91496175|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.736|TWO_SIDED|90.0|-2.6|3.8|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.8|-2.6|0.736
91496176|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.85||0.775|TWO_SIDED|90.0|-5.6|7.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||7.8|-5.6|0.775
91496177|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.0||0.553|TWO_SIDED|90.0|-9.4|4.5|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.5|-9.4|0.553
91496178|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.3||0.299|TWO_SIDED|90.0|-2.2|9.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||9.3|-2.2|0.299
91530561|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.399|STANDARD_ERROR_OF_MEAN|0.904||||90.0|-3.891|-0.907|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M21||-0.907|-3.891|
91530562|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.566|STANDARD_ERROR_OF_MEAN|0.788||||90.0|-2.867|-0.265|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M24||-0.265|-2.867|
91496179|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.65||0.994|TWO_SIDED|90.0|-1.1|1.1|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.1|0.994
91496180|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.87|TWO_SIDED|90.0|-0.9|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-0.9|0.870
91735904|NCT03648385|183365042|SUPERIORITY|||||||0.96|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.96
91735905|NCT03648385|183365043|SUPERIORITY|||||||0.91|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.91
91496181|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.74||0.885|TWO_SIDED|90.0|-1.3|1.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.3|0.885
91496182|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.834|TWO_SIDED|90.0|-3.5|2.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.7|-3.5|0.834
91530563|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.041||||90.0|-4.439|-1.001|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M27||-1.001|-4.439|
91735906|NCT03648385|183365043|SUPERIORITY|||||||0.61|||||||generalized estimating equations (GEE) w|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.61
91735907|NCT03648385|183365044|SUPERIORITY|||||||0.14|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.14
91735908|NCT03648385|183365044|SUPERIORITY|||||||0.84|||||||generalized estimating equations|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.84
91735909|NCT03648385|183365045|SUPERIORITY|||||||0.36|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.36
91496183|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.8||0.281|TWO_SIDED|90.0|-5.1|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-5.1|0.281
91496184|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.43||0.272|TWO_SIDED|90.0|-0.9|4.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.1|-0.9|0.272
91530564|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.401|STANDARD_ERROR_OF_MEAN|0.82||||90.0|-2.755|-0.047|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M30||-0.047|-2.755|
91530565|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.281|STANDARD_ERROR_OF_MEAN|0.908||||90.0|-3.781|-0.782|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M33||-0.782|-3.781|
91530566|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.766|STANDARD_ERROR_OF_MEAN|1.305||||90.0|-4.932|-0.599|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M36||-0.599|-4.932|
91530567|NCT00136916|182937342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.637|STANDARD_ERROR_OF_MEAN|0.898||||90.0|-3.12|-0.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext FU M3||-0.153|-3.120|
91530568|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.466|-0.037|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M3||-0.037|-0.466|
91530569|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.139||||90.0|-0.323|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.134|-0.323|
91530570|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.146||||90.0|-0.158|0.325|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M9||0.325|-0.158|
91530571|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.156||||90.0|-0.524|-0.009|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||-0.009|-0.524|
91530572|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|0.165||||90.0|-0.453|0.091|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M15||0.091|-0.453|
91735910|NCT03648385|183365045|SUPERIORITY|||||||0.71|||||||generalized estimating equations|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.71
91735911|NCT03648385|183365046|SUPERIORITY|||||||0.55|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.55
91735912|NCT03648385|183365046|SUPERIORITY|||||||0.44|||||||generalized estimating equations|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.44
91735913|NCT03648385|183365047|SUPERIORITY|||||||0.79|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.79
91735914|NCT03648385|183365047|SUPERIORITY|||||||0.34|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.34
91496185|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.249|TWO_SIDED|90.0|-2.1|0.4|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.4|-2.1|0.249
91496186|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|90.0|-2.9|-0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.6|-2.9|0.016
91496187|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.285|TWO_SIDED|0.285|-0.5|2.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.3|-0.5|0.285
91496188|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.38||0.635|TWO_SIDED|90.0|-3.1|1.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.8|-3.1|0.635
91496189|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.43||0.217|TWO_SIDED|90.0|-4.4|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-4.4|0.217
91496190|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.399|TWO_SIDED|90.0|-1.2|3.6|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.6|-1.2|0.399
91496191|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.429|TWO_SIDED|90.0|-1.5|0.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.5|-1.5|0.429
91496192|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.26|TWO_SIDED|90.0|-1.7|0.3|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.3|-1.7|0.260
91496193|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.799|TWO_SIDED|90.0|-1.0|1.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.3|-1.0|0.799
91530573|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.173||||90.0|-0.427|0.145|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M18||0.145|-0.427|
91735915|NCT03648385|183365048|SUPERIORITY|||||||0.33|||||||generalized estimating equations (GEE) w|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.33
91735916|NCT03648385|183365048|SUPERIORITY|||||||0.99|||||||generalized estimating equations (GEE) w|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.99
91735917|NCT03648385|183365049|SUPERIORITY|Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||||0.13|||||||generalized estimating equations (GEE)|||SF-36 PCS||||0.13
91496194|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.22||0.738|TWO_SIDED|90.0|-1.7|2.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.5|-1.7|0.738
91530574|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.176||||90.0|-0.445|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M21||0.134|-0.445|
91530575|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.189||||90.0|-0.193|0.431|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.431|-0.193|
91496195|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|-0.5||0.691|TWO_SIDED|90.0|-2.7|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-2.7|0.691
91496196|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.11||0.417|TWO_SIDED|90.0|-1.0|2.9|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.9|-1.0|0.417
91530576|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.617|STANDARD_ERROR_OF_MEAN|0.179||||90.0|0.322|0.911|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.911|0.322|
91530577|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.184||||90.0|0.051|0.657|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.657|0.051|
91530578|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.186||||90.0|0.011|0.626|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.626|0.011|
91530579|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.22||||90.0|-0.227|0.5|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.500|-0.227|
91530580|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.235||||90.0|-0.289|0.485|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.485|-0.289|
91530581|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.226||||90.0|-0.576|0.172|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||0.172|-0.576|
91530582|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.257||||90.0|-0.18|0.669|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M9||0.669|-0.180|
91496197|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.11||0.998|TWO_SIDED|90.0|-3.7|3.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.7|-3.7|0.998
91530583|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.248||||90.0|-0.284|0.535|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.535|-0.284|
91530584|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.253||||90.0|-0.395|0.441|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M15||0.441|-0.395|
91530585|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.262|0.554|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.554|-0.262|
91530586|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.321|STANDARD_ERROR_OF_MEAN|0.278||||90.0|-0.138|0.78|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M21||0.780|-0.138|
91530587|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.419|0.506|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.506|-0.419|
91530588|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.284||||90.0|-0.279|0.659|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M27||0.659|-0.279|
91530589|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.579|0.346|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.346|-0.579|
91530590|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.273||||90.0|-0.189|0.714|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M33||0.714|-0.189|
91530591|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.267|STANDARD_ERROR_OF_MEAN|0.383||||90.0|-0.37|0.904|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.904|-0.370|
91530592|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.244||||90.0|-0.003|0.802|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.802|-0.003|
91530593|NCT00136916|182937348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.619|STANDARD_ERROR_OF_MEAN|0.292||||90.0|0.137|1.102|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||1.102|0.137|
91530594|NCT01994720|182937358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.067|TWO_SIDED|95.0|0.78|1.01||In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.|Regression, Cox|||Composite of stroke/MI/death||1.01|0.78|0.0670
91530595|NCT01994720|182937359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0462|TWO_SIDED|95.0|0.76|1.0||If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.|Regression, Cox|||Ischemic stroke||1.00|0.76|0.0462
91530596|NCT01994720|182937360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0928|TWO_SIDED|95.0|0.79|1.02|||Regression, Cox|||||1.02|0.79|0.0928
91496198|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.16||0.353|TWO_SIDED|90.0|-5.8|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-5.8|0.353
91496199|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.296|TWO_SIDED|90.0|-1.3|5.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||5.4|-1.3|0.296
91496200|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95||0.841|TWO_SIDED|90.0|-1.8|1.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.5|-1.8|0.841
91496201|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.95||0.332|TWO_SIDED|90.0|-2.6|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-2.6|0.332
91530597|NCT01994720|182937361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0771|TWO_SIDED|95.0|0.78|1.01|||Regression, Cox|||||1.01|0.78|0.0771
91530598|NCT01994720|182937362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.3641|TWO_SIDED|95.0|0.83|1.67|||Regression, Cox|||||1.67|0.83|0.3641
91530599|NCT01994720|182937363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4828|TWO_SIDED|95.0|0.75|1.85|||Regression, Cox|||||1.85|0.75|0.4828
91530600|NCT01994720|182937364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.5457|TWO_SIDED|95.0|0.67|2.14|||Regression, Cox|||||2.14|0.67|0.5457
91530601|NCT01994720|182937365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.1393|TWO_SIDED|95.0|0.85|1.02|||Regression, Logistic|||||1.02|0.85|0.1393
91530602|NCT01994720|182937366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0342|TWO_SIDED|95.0|0.75|0.99|||Regression, Cox|||||0.99|0.75|0.0342
91530603|NCT01994720|182937367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.8557|TWO_SIDED|95.0|0.55|2.06|||Regression, Cox|||||2.06|0.55|0.8557
91530604|NCT01994720|182937368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2126|TWO_SIDED|95.0|0.77|1.06|||Regression, Cox|||||1.06|0.77|0.2126
91530605|NCT01994720|182937374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4511|TWO_SIDED|95.0|0.52|1.34|||Regression, Cox|||PLATO Major bleeding||1.34|0.52|0.4511
91530606|NCT01994720|182937375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.53|3.34|||Regression, Cox|||||3.34|1.53|<0.0001
91530607|NCT01991197|182937376|SUPERIORITY||U value|43.5||||0.648|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.648
91530608|NCT01991197|182937379|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91530609|NCT01991197|182937382|SUPERIORITY||U|29.5||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
91530610|NCT01012973|182937392|SUPERIORITY_OR_OTHER||CMH adjusted difference|38.3|||<|0.0001|TWO_SIDED|95.0|24.4|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as Eylea minus Sham. A positive value shows Eylea showed a higher BCVA total score compared to Sham.|Null hypothesis of difference of Eylea minus Sham of 0 was tested. In the database close after Week 24, basis for primary efficacy evaluation, 56 Sham / 96 Eylea subjects were considered as week 24 completers.||52.1|24.4|<.0001
91530611|NCT01012973|182937393|SUPERIORITY_OR_OTHER||Difference in Least square means|14.7|||<|0.0001|TWO_SIDED|95.0|10.8|18.7||As primary efficacy evaluation was significant, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANOVA|ANOVA, adjusting for region and baseline BCVA category as fixed factors.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham. If primary efficacy was successful, secondary efficacy endpoints were tested in a pre-specified fixed sequence testing procedure. Change in BCVA letter score was to be tested first in this sequence.||18.7|10.8|<.0001
91530612|NCT01012973|182937394|SUPERIORITY_OR_OTHER||Difference in Least square (LS) means|-239.42|||<|0.0001|TWO_SIDED|95.0|-286.31|-192.53||As fixed sequence testing did reject nullhypothesis of change from baseline in BCVA until week 24, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANCOVA|ANCOVA, stratified by region and baseline BCVA category, baseline central retinal thickness added as covariate.|The difference is calculated as Eylea minus Sham. A negative value indicates Eylea showed a higher reduction in change in central retinal thickness until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in central retinal thickness between Eylea and Sham. If primary efficacy was successful, secondary efficacy end points were to be tested in a pre-specified fixed sequence testing procedure. Change in central retinal thickness was to be tested at second place in this sequence.||-192.53|-286.31|<.0001
91530613|NCT01012973|182937395|SUPERIORITY_OR_OTHER||CMH adjusted Difference|-1.5||||0.5947|TWO_SIDED|95.0|-7.4|4.4||As fixed sequence testing did reject nullhypothesis of change from baseline in CRT until week 24, and this p-value was not below significance level of two-sided \<.05, the fixed sequence testing did end with this evaluation.|Cochran-Mantel-Haenszel|Cochrane-Mantel-Haenszel test, stratified by region and baseline BCVA category.||Nullhypothesis of no difference in development of neovascularizations between Eylea and Sham group was tested. (Any neovascularization)||4.4|-7.4|0.5947
91530614|NCT01012973|182937396|SUPERIORITY_OR_OTHER||Difference in LS means|4.2|||||TWO_SIDED|95.0|1.7|6.8|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||6.8|1.7|
91530615|NCT01012973|182937397|SUPERIORITY_OR_OTHER||Difference in LS Means|0.044|||||TWO_SIDED|95.0|-0.002|0.09|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||0.09|-0.002|
91530616|NCT02923895|182937402|SUPERIORITY|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|Mean Difference (Net)|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.128||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.128|-1.500|<.0001
91530617|NCT00846742|182937406|SUPERIORITY|||||||0.0003||||||Comparison of proportion of patients' complete response rate between HOD99 (NCT number: NCT00145600) and HOD08|Exact Binominal Test|||The proportion of patients' complete response rate was provided with a 95% confidence interval.||||0.0003
91530618|NCT00846742|182937411|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.732|TWO_SIDED|95.0|0.81|1.159|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure with a 1-year increase in age.|||1.159|0.810|0.732
91530619|NCT00846742|182937412|SUPERIORITY||Hazard Ratio (HR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing males to females.|Male vs. Female, with Female as the reference level||0.000|0.000|<0.001
91530620|NCT00846742|182937413|SUPERIORITY||Hazard Ratio (HR)|30101.41|||<|0.001|TWO_SIDED|95.0|3329.573|272135.5|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Stage IIA to Stage IA.|Stage IIA vs. Stage IA, with Stage IA as the reference level||272135.500|3329.573|<0.001
91530621|NCT00846742|182937414|SUPERIORITY||Hazard Ratio (HR)|34027.68|||<|0.001|TWO_SIDED|95.0|4072.872|284291.6|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Classical (all combined) to Nodular Lymphocyte Predominant Hodgkin Lymphoma.|Classical (all combined) vs. Nodular lymphocyte predominant, with Nodular lymphocyte predominant as the reference level||284291.600|4072.872|<0.001
91530622|NCT00846742|182937415|SUPERIORITY|||||||0.461|||||||Log Rank|||Comparing the 2-year EFS between HOD08 Participants and HOD99 Participants||||0.461
91530623|NCT00846742|182937415|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 Participants and HOD99 Participants||||1.000
91530624|NCT00846742|182937415|SUPERIORITY|||||||0.836|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 Participants and HOD99 Participants||||0.836
91530625|NCT00846742|182937417|SUPERIORITY|||||||0.384|||||||Log Rank|||Comparing the 2-year EFS between HOD08 - CR and HOD99 - CR||||0.384
91530626|NCT00846742|182937417|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 - CR and HOD99 - CR||||1.000
91530627|NCT00846742|182937417|SUPERIORITY|||||||0.386|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 - CR and HOD99 - CR||||0.386
91530628|NCT00846742|182937418|SUPERIORITY|||||||0.986|||||||Log Rank|||Comparing the 2-year EFS of patients treated without and with RT||||0.986
91530629|NCT02341144|182937457|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91530630|NCT02341144|182937458|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91530631|NCT02341144|182937459|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91530632|NCT02341144|182937460|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91530633|NCT02341144|182937461|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91530634|NCT03257995|182937496|OTHER||Mean Difference (Final Values)|0.1861|||<|0.001|TWO_SIDED|95.0|0.1293|0.2429|||ANOVA|||||0.2429|0.1293|<0.001
91530635|NCT03257995|182937496|OTHER||Mean Difference (Final Values)|0.1463|||<|0.001|TWO_SIDED|95.0|0.0898|0.2029|||ANOVA|||||0.2029|0.0898|<0.001
91530636|NCT03257995|182937496|OTHER||Mean Difference (Final Values)|-0.0398|||||TWO_SIDED|95.0|-0.0942|0.0147|||ANOVA|||||0.0147|-0.0942|
91530637|NCT03257995|182937502|OTHER||Median Difference (Final Values)|-0.02||||0.823|TWO_SIDED|95.0|-0.83|0.33|||Wilcoxon (Mann-Whitney)|||||0.33|-0.83|0.823
91530638|NCT03257995|182937502|OTHER||Median Difference (Final Values)|-0.02||||0.801|TWO_SIDED|95.0|-0.82|0.51|||Wilcoxon (Mann-Whitney)|||||0.51|-0.82|0.801
91530639|NCT03257995|182937502|OTHER||Median Difference (Final Values)|0.0||||0.984|TWO_SIDED|95.0|-0.5|0.73|||Wilcoxon (Mann-Whitney)|||||0.73|-0.50|0.984
91530640|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2177|||<|0.001|TWO_SIDED|95.0|0.1482|0.2872|||ANOVA|||at 5 min||0.2872|0.1482|<0.001
91530641|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2724|||<|0.001|TWO_SIDED|95.0|0.203|0.3417|||ANOVA|||15min||0.3417|0.2030|<0.001
91530642|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.273|||<|0.001|TWO_SIDED|95.0|0.2036|0.3423|||ANOVA|||30 min||0.3423|0.2036|<0.001
91530643|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2609|||<|0.001|TWO_SIDED|95.0|0.1915|0.3302|||ANOVA|||1 hour||0.3302|0.1915|<0.001
91530644|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2494|||<|0.001|TWO_SIDED|95.0|0.18|0.3188|||ANOVA|||2 hour||0.3188|0.1800|<0.001
91530645|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2273|||<|0.001|TWO_SIDED|95.0|0.1578|0.2968|||ANOVA|||4 hour||0.2968|0.1578|<0.001
91530646|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2396|||<|0.001|TWO_SIDED|95.0|0.1697|0.3096|||ANOVA|||8 hour||0.3096|0.1697|<0.001
91530647|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2443|||<|0.001|TWO_SIDED|95.0|0.1742|0.3144|||ANOVA|||12 hour||0.3144|0.1742|<0.001
91530648|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.228|||<|0.001|TWO_SIDED|95.0|0.1563|0.2997|||ANOVA|||23 hour 15 min||0.2997|0.1563|<0.001
91530649|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.1954|||<|0.001|TWO_SIDED|95.0|0.1237|0.2671|||ANOVA|||23 hour 45 min||0.2671|0.1237|<0.001
91530650|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2195|||<|0.001|TWO_SIDED|95.0|0.1502|0.2889|||ANOVA|||5 min||0.2889|0.1502|<0.001
91530651|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2684|||<|0.001|TWO_SIDED|95.0|0.1988|0.338|||ANOVA|||15 min||0.3380|0.1988|<0.001
91530652|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2572|||<|0.001|TWO_SIDED|95.0|0.1879|0.3266|||ANOVA|||30 min||0.3266|0.1879|<0.001
91530653|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2348|||<|0.001|TWO_SIDED|95.0|0.1656|0.304|||ANOVA|||1 hour||0.3040|0.1656|<0.001
91530654|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2546|||<|0.001|TWO_SIDED|95.0|0.1852|0.3239|||ANOVA|||2 hour||0.3239|0.1852|<0.001
91530655|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2322|||<|0.001|TWO_SIDED|95.0|0.1627|0.3017|||ANOVA|||4 hour||0.3017|0.1627|<0.001
91735918|NCT03648385|183365049|SUPERIORITY|Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||||0.044|||||||generalized estimating equations (GEE)|||SF-36 PCS||||0.044
91735919|NCT03648385|183365049|SUPERIORITY|Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||||0.77|||||||generalized estimating equations (GEE)|||SF-36 MCS||||0.77
91530656|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2324|||<|0.001|TWO_SIDED|95.0|0.1627|0.302|||ANOVA|||8 hour||0.3020|0.1627|<0.001
91530657|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.2057|||<|0.001|TWO_SIDED|95.0|0.1359|0.2755|||ANOVA|||12 hour||0.2755|0.1359|<0.001
91530658|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.1625|||<|0.001|TWO_SIDED|95.0|0.0912|0.2337|||ANOVA|||23 hour 15 min||0.2337|0.0912|<0.001
91530659|NCT03257995|182937503|OTHER||Mean Difference (Final Values)|0.1793|||<|0.001|TWO_SIDED|95.0|0.108|0.2505|||ANOVA|||23 hour 45 min||0.2505|0.1080|<0.001
91530660|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<.001
91530661|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.4|10.6|||ANOVA|||at 15 min||10.6|6.4|<.001
91530662|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|8.6|||<|0.001|TWO_SIDED|95.0|6.5|10.7|||ANOVA|||at 30||10.7|6.5|<0.001
91530663|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|8.0|||<|0.001|TWO_SIDED|95.0|6.0|10.1|||ANOVA|||at 1 hour||10.1|6.0|<0.001
91530664|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 2 hours||9.7|5.5|<0.001
91530665|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.1|||ANOVA|||at 4 hours||9.1|5.0|<0.001
91530666|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 8 hours||9.4|5.2|<0.001
91530667|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 12 hours||9.7|5.5|<0.001
91530668|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.0|||<|0.001|TWO_SIDED|95.0|4.8|9.1|||ANOVA|||at 23 hours 15 min||9.1|4.8|<0.001
91530669|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|6.4|||<|0.001|TWO_SIDED|95.0|4.2|8.6|||ANOVA|||at 23 hours 45 min||8.6|4.2|<0.001
91530670|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<0.001
91530671|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|8.3|||<|0.001|TWO_SIDED|95.0|6.2|10.4|||ANOVA|||at 15 min||10.4|6.2|<0.001
91530672|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|8.1|||<|0.001|TWO_SIDED|95.0|6.0|10.2|||ANOVA|||at 30 min||10.2|6.0|<0.001
91530673|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.4|||ANOVA|||at 1 hour||9.4|5.3|<0.001
91530674|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.8|||<|0.001|TWO_SIDED|95.0|5.7|9.9|||ANOVA|||at 2 hours||9.9|5.7|<0.001
91530675|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 4 hours||9.4|5.2|<0.001
91530676|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.5|||ANOVA|||at 8 hours||9.5|5.3|<0.001
91530677|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.2|8.4|||ANOVA|||at 12 hours||8.4|4.2|<0.001
91530678|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|5.1|||<|0.001|TWO_SIDED|95.0|2.9|7.2|||ANOVA|||at 23 hours 15 min||7.2|2.9|<0.001
91530679|NCT03257995|182937504|OTHER||Mean Difference (Final Values)|5.9|||<|0.001|TWO_SIDED|95.0|3.7|8.0|||ANOVA|||at 23 hours 45 min||8.0|3.7|<0.001
91530680|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1866|||<|0.001|TWO_SIDED|95.0|0.1121|0.2611|||ANOVA|||5 min||0.2611|0.1121|<0.001
91530681|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2249|||<|0.001|TWO_SIDED|95.0|0.1506|0.2992|||ANOVA|||15 min||0.2992|0.1506|<0.001
91530682|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2404|||<|0.001|TWO_SIDED|95.0|0.1661|0.3148|||ANOVA|||30 min||0.3148|0.1661|<0.001
91530683|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2074|||<|0.001|TWO_SIDED|95.0|0.133|0.2817|||ANOVA|||1 hour||0.2817|0.1330|<0.001
91530684|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1802|||<|0.001|TWO_SIDED|95.0|0.1059|0.2545|||ANOVA|||2 hours||0.2545|0.1059|<0.001
91530685|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1621|||<|0.001|TWO_SIDED|95.0|0.0876|0.2366|||ANOVA|||4 hours||0.2366|0.0876|<0.001
91530686|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.199|||<|0.001|TWO_SIDED|95.0|0.1239|0.2742|||ANOVA|||8 hours||0.2742|0.1239|<0.001
91735920|NCT03648385|183365049|SUPERIORITY|Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||||0.98|||||||generalized estimating equations (GEE)|||SF-MCS||||0.98
91735921|NCT03648385|183365050|SUPERIORITY|||||||0.7|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.70
91735922|NCT03648385|183365050|SUPERIORITY|||||||0.037|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.037
91735923|NCT03648385|183365051|SUPERIORITY|||||||0.005|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||0.005
91735924|NCT03648385|183365051|SUPERIORITY|||||||0.9|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.9
91735925|NCT03648385|183365052|SUPERIORITY||||||<|0.0001|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, measurement of % change at 18 Weeks Treatment period 1: Placebo to DHEA group, % change at 18 Weeks||||<0.0001
91735926|NCT03648385|183365052|SUPERIORITY|||||||0.034|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, % change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, % change between 18 and 40 Weeks||||0.034
91735927|NCT03648385|183365053|SUPERIORITY|||||||0.36|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, at 18 Weeks||||0.36
91735928|NCT03648385|183365053|SUPERIORITY|||||||0.23|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.23
91735929|NCT03648385|183365054|SUPERIORITY|||||||0.002|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.002
91735930|NCT03648385|183365054|SUPERIORITY||||||<|0.0001|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||<0.0001
91735931|NCT03648385|183365055|SUPERIORITY|||||||0.42|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.42
91735932|NCT03648385|183365055|SUPERIORITY|||||||0.28|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.28
91735933|NCT03648385|183365056|SUPERIORITY|||||||0.08|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.08
91530687|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1747|||<|0.001|TWO_SIDED|95.0|0.0994|0.2501|||ANOVA|||12 hours||0.2501|0.0994|<0.001
91735934|NCT03648385|183365056|SUPERIORITY|||||||0.65|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.65
91735935|NCT03648385|183365057|SUPERIORITY|||||||0.07|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.07
91735936|NCT03648385|183365057|SUPERIORITY||||||<|0.01|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||<0.01
91735937|NCT03648385|183365058|SUPERIORITY|||||||0.27|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, measurement of change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.27
91735938|NCT03648385|183365058|SUPERIORITY|||||||0.26|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.26
91530688|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1856|||<|0.001|TWO_SIDED|95.0|0.1081|0.2631|||ANOVA|||23 hours 15 min||0.2631|0.1081|<0.001
91530689|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1484|||<|0.001|TWO_SIDED|95.0|0.0709|0.2259|||ANOVA|||23 hours 45 min||0.2259|0.0709|<0.001
91530690|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.1386|0.2873|||ANOVA|||5 min||0.2873|0.1386|<0.001
91530691|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2173|||<|0.001|TWO_SIDED|95.0|0.1426|0.292|||ANOVA|||15 min||0.2920|0.1426|<0.001
91530692|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2375|||<|0.001|TWO_SIDED|95.0|0.1632|0.3118|||ANOVA|||30 min||0.3118|0.1632|<0.001
91530693|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2013|||<|0.001|TWO_SIDED|95.0|0.1272|0.2754|||ANOVA|||1 hour||0.2754|0.1272|<0.001
91530694|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.2005|||<|0.001|TWO_SIDED|95.0|0.1262|0.2749|||ANOVA|||2 hours||0.2749|0.1262|<0.001
91530695|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1946|||<|0.001|TWO_SIDED|95.0|0.1201|0.2691|||ANOVA|||4 hours||0.2691|0.1201|<0.001
91735939|NCT03648385|183365059|SUPERIORITY|||||||0.81|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.81
91735940|NCT03648385|183365059|SUPERIORITY|||||||0.94|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.94
91735941|NCT03648385|183365060|SUPERIORITY|||||||0.93|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.93
91735942|NCT03648385|183365060|SUPERIORITY|||||||0.83|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.83
91735943|NCT03648385|183365061|SUPERIORITY|||||||0.85|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.85
91735944|NCT03648385|183365061|SUPERIORITY|||||||0.74|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.74
91735945|NCT03648385|183365062|SUPERIORITY|||||||0.004|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.004
91496202|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.81||0.359|TWO_SIDED|90.0|-0.6|2.2|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.2|-0.6|0.359
91496203|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78||0.347|TWO_SIDED|90.0|-2.1|0.6|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-2.1|0.347
91496204|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.041|TWO_SIDED|90.0|-3.2|-0.4|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.4|-3.2|0.041
91496205|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.79||0.212|TWO_SIDED|90.0|-0.4|2.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.4|-0.4|0.212
91496206|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.69||0.954|TWO_SIDED|90.0|-1.2|1.2|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.2|-1.2|0.954
91496207|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.407|TWO_SIDED|90.0|-1.8|0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-1.8|0.407
91496208|NCT02310568|182864231|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.66||0.412|TWO_SIDED|90.0|-0.6|1.7|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-0.6|0.412
91496209|NCT02310568|182864232|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.45||0.856|TWO_SIDED|90.0|-2.2|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.7|-2.2|0.856
91496210|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.647|TWO_SIDED|90.0|-1.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.9|-1.7|0.647
91496211|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.817|TWO_SIDED|90.0|-3.0|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.3|-3.0|0.817
91496212|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.81||0.67|TWO_SIDED|90.0|-3.8|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.2|-3.8|0.670
91735946|NCT03648385|183365062|SUPERIORITY|||||||0.05|||||||generalized estimating equations (GEE)|||||||0.05
91496213|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.74||0.736|TWO_SIDED|90.0|-2.3|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.5|-2.3|0.736
91530696|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1937|||<|0.001|TWO_SIDED|95.0|0.119|0.2684|||ANOVA|||8 hours||0.2684|0.1190|<0.001
91530697|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1619|||<|0.001|TWO_SIDED|95.0|0.087|0.2369|||ANOVA|||12 hour||0.2369|0.0870|<0.001
91530698|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1249|||<|0.001|TWO_SIDED|95.0|0.048|0.2018|||ANOVA|||23 hour 15 min||0.2018|0.0480|<0.001
91735947|NCT03648385|183365063|SUPERIORITY|||||||0.33|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.33
91735948|NCT03648385|183365063|SUPERIORITY|||||||0.23|||||||generalized estimating equations|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.23
91735949|NCT03648385|183365064|SUPERIORITY|||||||0.19|||||||generalized estimating equations (GEE)|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.19
91735950|NCT03648385|183365064|SUPERIORITY|||||||0.94|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.94
91735951|NCT03648385|183365065|SUPERIORITY|||||||0.62|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.62
91735952|NCT03648385|183365065|SUPERIORITY|||||||0.39|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.39
91735953|NCT03648385|183365066|SUPERIORITY|||||||0.33|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.33
91735954|NCT03648385|183365066|SUPERIORITY|||||||0.88|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||0.88
91735955|NCT03648385|183365067|SUPERIORITY|||||||0.55|||||||generalized estimating equations|||Treatment period 1: DHEA to Placebo group, change at 18 Weeks Treatment period 1: Placebo to DHEA group, change at 18 Weeks||||0.55
91735956|NCT03648385|183365067|SUPERIORITY|||||||1|||||||generalized estimating equations (GEE)|||Treatment period 2: DHEA to Placebo group, change between 18 and 40 Weeks Treatment period 2: Placebo to DHEA group, change between 18 and 40 Weeks||||1.00
91735957|NCT00928668|183365075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.157|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|0.657|1.657|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.657|0.657|<0.0001
91735958|NCT00928668|183365075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.711|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|1.205|2.217|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.217|1.205|<0.0001
91735959|NCT00928668|183365075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.443|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|1.952|2.935|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.935|1.952|<0.0001
91735960|NCT00928668|183365075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.984|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|2.486|3.483|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.483|2.486|<0.0001
91735961|NCT00928668|183365076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.139|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|1.645|2.633|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.633|1.645|<0.0001
91735962|NCT00928668|183365076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.636|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|2.135|3.136|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.136|2.135|<0.0001
91735963|NCT00928668|183365076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|3.074|4.046|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.046|3.074|<0.0001
91735964|NCT00928668|183365076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.224|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|3.731|4.717|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.717|3.731|<0.0001
91735965|NCT00928668|183365077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.025|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|1.437|2.613|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.613|1.437|<0.0001
91735966|NCT00928668|183365077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.785|2.975|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.975|1.785|<0.0001
91735967|NCT00928668|183365077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549|STANDARD_ERROR_OF_MEAN|0.292|<|0.0001|TWO_SIDED|95.0|2.971|4.127|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.127|2.971|<0.0001
91735968|NCT00928668|183365077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.208|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|3.622|4.794|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.794|3.622|<0.0001
91735969|NCT00928668|183365078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.907|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|1.322|2.492|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.492|1.322|<0.0001
91735970|NCT00928668|183365078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474|STANDARD_ERROR_OF_MEAN|0.299|<|0.0001|TWO_SIDED|95.0|1.822|3.066|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.066|1.822|<0.0001
91735971|NCT00928668|183365078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.327|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|2.752|3.902|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||3.902|2.752|<0.0001
91735972|NCT00928668|183365078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|3.637|4.803|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.803|3.637|<0.0001
91735973|NCT00928668|183365079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.692|1.766|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.766|0.692|<0.0001
91735974|NCT00928668|183365079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.281|2.369|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.369|1.281|<0.0001
91735975|NCT00928668|183365079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.114|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.578|2.65|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.650|1.578|<0.0001
91735976|NCT00928668|183365079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|2.11|3.181|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.181|2.110|<0.0001
91735977|NCT00934921|183365084|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.1||||||90.0|91.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.2|
91735978|NCT00934921|183365085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.2||||||90.0|88.8|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|88.8|
91496214|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.99||0.496|TWO_SIDED|90.0|-4.7|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.0|-4.7|0.496
91530699|NCT03257995|182937505|OTHER||Mean Difference (Final Values)|0.1546|||<|0.001|TWO_SIDED|95.0|0.0777|0.2315|||ANOVA|||23 hour 45 min||0.2315|0.0777|<0.001
91735979|NCT00934921|183365086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.9||||||90.0|89.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|89.5|
91735980|NCT01968980|183365150|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-54.5|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-59.5|-49.5|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-49.5|-59.5|<0.001
91735981|NCT01968980|183365151|SUPERIORITY_OR_OTHER||LS mean difference|-37.6|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-41.1|-34.1|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-34.1|-41.1|<0.001
91735982|NCT01968980|183365152|SUPERIORITY_OR_OTHER||LS mean difference|-51.0|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-55.7|-46.4|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.4|-55.7|<0.001
91735983|NCT01968980|183365153|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-52.8|-43.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-43.2|-52.8|<0.001
91735984|NCT01968980|183365154|SUPERIORITY_OR_OTHER||LS mean difference|-28.6|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-33.9|-23.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-23.2|-33.9|<0.001
91735985|NCT01968980|183365155|SUPERIORITY_OR_OTHER||LS mean difference|7.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.1|9.9|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||9.9|4.1|<0.001
91735986|NCT01968980|183365156|SUPERIORITY_OR_OTHER||LS mean difference|-52.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-58.2|-46.0||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.0|-58.2|
91496215|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.72||0.575|TWO_SIDED|90.0|-1.9|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.8|-1.9|0.575
91496216|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.67||0.362|TWO_SIDED|90.0|-1.2|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||4.3|-1.2|0.362
91735987|NCT01968980|183365156|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|95.0|-53.6|-42.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.3|-53.6|
91735988|NCT01968980|183365157|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-40.0|-31.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-31.6|-40.0|
91735989|NCT01968980|183365157|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.8|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-35.8|-27.8||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-27.8|-35.8|
91735990|NCT01968980|183365158|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.5|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-54.1|-42.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.8|-54.1|
91735991|NCT01968980|183365158|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.2|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-47.5|-36.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-36.9|-47.5|
91735992|NCT01968980|183365159|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.8|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-52.1|-41.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-41.6|-52.1|
91735993|NCT01968980|183365159|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.5|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-45.5|-35.5||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-35.5|-45.5|
91735994|NCT01968980|183365160|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1|STANDARD_ERROR_OF_MEAN|12.58|||TWO_SIDED|95.0|-59.8|-10.3||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-10.3|-59.8|
91735995|NCT01968980|183365160|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-26.3|-4.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-4.4|-26.3|
91735996|NCT01968980|183365161|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|3.1|8.7||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||8.7|3.1|
91735997|NCT01968980|183365161|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.1|5.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.9|-0.1|
91735998|NCT01968980|183365162|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
91530700|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||5 min||7.0|3.1|<0.001
91530701|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|4.0|7.9|||ANOVA|||15 min||7.9|4|<0.001
91530702|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|6.6|||<|0.001|TWO_SIDED|95.0|4.6|8.5|||ANOVA|||30 min||8.5|4.6|<0.001
91530703|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||1 hour||7.4|3.5|<0.001
91530704|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.7|||<|0.001|TWO_SIDED|95.0|2.8|6.7|||ANOVA|||2 hour||6.7|2.8|<0.001
91530705|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.3|||<|0.001|TWO_SIDED|95.0|2.3|6.3|||ANOVA|||4 hour||6.3|2.3|<0.001
91530706|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7|3|<0.001
91530707|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.5|||<|0.001|TWO_SIDED|95.0|2.5|6.5|||ANOVA|||12 hour||6.5|2.5|<0.001
91530708|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.6|||<|0.001|TWO_SIDED|95.0|2.6|6.7|||ANOVA|||23 hour 15 min||6.7|2.6|<0.001
91530709|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.0|6.2|||ANOVA|||23 hour 45 min||6.2|2.0|<0.001
91530710|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||5 min||7.8|3.9|<0.001
91530711|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||15 min||7.8|3.9|<0.001
91530712|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.4|8.3|||ANOVA|||30 min||8.3|4.4|<0.001
91530713|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.5|||ANOVA|||1 hour||7.5|3.5|<0.001
91530714|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||2 hour||7.4|3.5|<0.001
91530715|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||4 hour||7.0|3.1|<0.001
91530716|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7.0|3.0|<0.001
91530717|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANOVA|||12 hour||6.2|2.2|<0.001
91530718|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|3.0||||0.004|TWO_SIDED|95.0|1.0|5.0|||ANOVA|||23 hour 15 min||5.0|1.0|0.004
91530719|NCT03257995|182937506|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||ANOVA|||23 hour 45 min||6.1|2.1|<0.001
91530720|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0249|||<|0.001|TWO_SIDED|95.0|0.0139|0.0359|||ANOVA|||5 min||0.0359|0.0139|<.001
91530721|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.033|||<|0.001|TWO_SIDED|95.0|0.022|0.044|||ANOVA|||15 min||0.0440|0.0220|<.001
91530722|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0306|||<|0.001|TWO_SIDED|95.0|0.0197|0.0416|||ANOVA|||30 min||0.0416|0.0197|<0.001
91530723|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0324|||<|0.001|TWO_SIDED|95.0|0.0214|0.0434|||ANOVA|||1 hour||0.0434|0.0214|<0.001
91530724|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
91530725|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0325|||<|0.001|TWO_SIDED|95.0|0.0215|0.0435|||ANOVA|||4 hour||0.0435|0.0215|<0.001
91735999|NCT01968980|183365162|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
91736000|NCT01968980|183365162|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
91736001|NCT01968980|183365163|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|2.9|7.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||7.8|2.9|
91736002|NCT01968980|183365163|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|2.5|6.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||6.8|2.5|
91736003|NCT01968980|183365163|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|0.5|5.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.4|0.5|
91736004|NCT01968980|183365164|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.3|3.6||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-2.3|
91736005|NCT01968980|183365164|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-1.9|3.2||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.2|-1.9|
91736006|NCT01968980|183365164|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-1.9|3.6||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-1.9|
91736007|NCT01968980|183365165|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
91736008|NCT01968980|183365165|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
91736009|NCT01968980|183365165|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
91736010|NCT01968980|183365166|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.8|STANDARD_ERROR_OF_MEAN|3.75|||TWO_SIDED|95.0|-86.2|-71.4||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-71.4|-86.2|
91736011|NCT01968980|183365167|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.2|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-91.3|-75.0||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-75.0|-91.3|
91736012|NCT01968980|183365168|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.0|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-95.4|-78.7||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-78.7|-95.4|
91736013|NCT01968980|183365169|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-59.2|-48.5||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-48.5|-59.2|
91736014|NCT01968980|183365170|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-14.7|-8.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.9|-14.7|
91530726|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0311|||<|0.001|TWO_SIDED|95.0|0.02|0.0422|||ANOVA|||8 hour||0.0422|0.0200|<0.001
91530727|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0359|||<|0.001|TWO_SIDED|95.0|0.0248|0.047|||ANOVA|||12 hour||0.0470|0.0248|<0.001
91496217|NCT02310568|182864232|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.9||0.771|TWO_SIDED|90.0|-3.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.6|-3.7|0.771
91702460|NCT00772005|183299699|SUPERIORITY_OR_OTHER|||||||0.3973||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3973
91736015|NCT01968980|183365171|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|2.0|4.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||4.9|2.0|
91736016|NCT01968980|183365172|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-2.2|-1.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.8|-2.2|
91736017|NCT01968980|183365172|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.1|-1.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.6|-2.1|
91736018|NCT01968980|183365172|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.8|-1.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.3|-1.8|
91736019|NCT01968980|183365173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.5|-0.4||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.5|
91736020|NCT01968980|183365173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.4||||||Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.4|
91496218|NCT02310568|182864233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.45|1.26|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.26|0.45|
91496219|NCT02310568|182864233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|90.0|0.23|1.54|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.54|0.23|
91496220|NCT02310568|182864233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|90.0|0.69|2.32|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.32|0.69|
91530728|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0326|||<|0.001|TWO_SIDED|95.0|0.0211|0.044|||ANOVA|||23 hour 15 min||0.0440|0.0211|<0.001
91530729|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0301|||<|0.001|TWO_SIDED|95.0|0.0187|0.0415|||ANOVA|||23 hour 45 min||0.0415|0.0187|<0.001
91702461|NCT00772005|183299700|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4030
91530730|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0222|||<|0.001|TWO_SIDED|95.0|0.0113|0.0332|||ANOVA|||5 min||0.0332|0.0113|<0.001
91702462|NCT00772005|183299700|SUPERIORITY_OR_OTHER|||||||0.3777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3777
91702463|NCT00772005|183299700|SUPERIORITY_OR_OTHER|||||||0.6493||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6493
91736021|NCT01968980|183365173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.3|-0.4|
91736022|NCT01968980|183365174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.8|||||TWO_SIDED|95.0|25.24|106.1||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||106.10|25.24|
91736023|NCT01968980|183365174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|66.9|||||TWO_SIDED|95.0|30.32|147.43||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||147.43|30.32|
91736024|NCT01968980|183365174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.8|||||TWO_SIDED|95.0|11.85|44.01||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||44.01|11.85|
91736025|NCT01968980|183365175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|200.8|||||TWO_SIDED|95.0|47.16|854.6||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||854.60|47.16|
91736026|NCT01968980|183365175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|228.0|||||TWO_SIDED|95.0|51.95|1000.39||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1000.39|51.95|
91736027|NCT01968980|183365175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|259.9|||||TWO_SIDED|95.0|34.87|1937.06||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1937.06|34.87|
91736028|NCT01561469|183365216|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Regression, Logistic|||||||0.009
91736029|NCT01561469|183365217|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Analysis for superinfections category reported.||||1.00
91736030|NCT01561469|183365217|SUPERIORITY_OR_OTHER|||||||0.759|TWO_SIDED||||||Chi-squared|||Analysis for colonization category reported.||||0.759
91736031|NCT01561469|183365218|SUPERIORITY_OR_OTHER|||||||0.773|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.773
91736032|NCT01561469|183365219|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.823
91736033|NCT01561469|183365220|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.276
91736034|NCT01561469|183365221|SUPERIORITY_OR_OTHER|||||||0.512|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.512
91736035|NCT00285779|183365241|SUPERIORITY_OR_OTHER|||||||0.0978|TWO_SIDED||||||Fisher Exact|||||||0.0978
91736036|NCT00285779|183365242|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
91496221|NCT02310568|182864233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||||TWO_SIDED|90.0|0.27|5.78|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||5.78|0.27|
91496222|NCT02310568|182864233|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.13|||||TWO_SIDED|90.0|0.19|24.51|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||24.51|0.19|
91736037|NCT00285779|183365243|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
91736038|NCT00285779|183365243|OTHER|||||||0.34|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.34
91736039|NCT00285779|183365243|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
91736040|NCT00285779|183365243|OTHER|||||||0.22|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.22
91736041|NCT00285779|183365244|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
91736042|NCT00285779|183365244|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
91736043|NCT00285779|183365245|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
91736044|NCT00285779|183365245|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
91736045|NCT00285779|183365245|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.063
91736046|NCT00285779|183365245|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
91736047|NCT00285779|183365246|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.063
91736048|NCT00285779|183365246|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
91736049|NCT00285779|183365246|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.031
91736050|NCT00285779|183365246|OTHER|||||||0.32|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.32
91736051|NCT00285779|183365247|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
91736052|NCT00285779|183365247|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
91736053|NCT00285779|183365247|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
91736054|NCT00285779|183365247|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
91736055|NCT00285779|183365248|OTHER|||||||0.63|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.63
91736056|NCT00285779|183365248|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.38
91736057|NCT00285779|183365248|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.38
91736058|NCT00285779|183365248|OTHER|||||||0.5|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.50
91736059|NCT00285779|183365249|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
91736060|NCT00285779|183365249|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
91736061|NCT00285779|183365249|OTHER|||||||0.039|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.039
91736062|NCT00285779|183365249|OTHER|||||||0.19|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.19
91736063|NCT00285779|183365250|OTHER|||||||0.26|||||||Paired t test|||Week 12 versus baseline||||0.26
91736064|NCT00285779|183365250|OTHER|||||||0.55|||||||Paired t test|||Week 12 versus baseline||||0.55
91736065|NCT00285779|183365250|OTHER|||||||0.18|||||||Paired t test|||Week 24 versus baseline||||0.18
91736066|NCT00285779|183365250|OTHER|||||||0.13|||||||Paired t test|||Week 24 versus baseline||||0.13
91736067|NCT00285779|183365251|OTHER|||||||0.51|||||||Paired t test|||Week 12 versus baseline||||0.51
91736068|NCT00285779|183365251|OTHER|||||||0.47|||||||Paired t test|||Week 24 versus baseline||||0.47
91736069|NCT00285779|183365251|OTHER|||||||0.087|||||||Paired t test|||Week 24 versus baseline||||0.087
91736070|NCT00285779|183365251|OTHER|||||||0.86|||||||Paired t test|||Week 24 versus baseline||||0.86
91736071|NCT00285779|183365252|OTHER|||||||0.033|||||||Paired t test|||Week 12 versus baseline||||0.033
91736072|NCT00285779|183365252|OTHER|||||||0.069|||||||Paired t test|||Week 12 versus baseline||||0.069
91736073|NCT00285779|183365252|OTHER|||||||0.015|||||||Paired t test|||Week 24 versus baseline||||0.015
91736074|NCT00285779|183365252|OTHER|||||||0.026|||||||Paired t test|||Week 24 versus baseline||||0.026
91736075|NCT03235050|183365312|SUPERIORITY||LS Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.59|||ANCOVA|||||-0.59|-1.06|<0.001
91736076|NCT03235050|183365312|SUPERIORITY||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.23|-0.85|||ANCOVA|||||-0.85|-1.23|<0.001
91736077|NCT03235050|183365312|SUPERIORITY||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.11|-0.72|||ANCOVA|||||-0.72|-1.11|<0.001
91736078|NCT03235050|183365313|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-3.08|-0.91|||ANCOVA|||||-0.91|-3.08|<0.001
91496223|NCT02310568|182864233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.16|2.09|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.09|0.16|
91496224|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.801|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.801
91702464|NCT00772005|183299701|SUPERIORITY_OR_OTHER|||||||0.9871||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9871
91736079|NCT03235050|183365313|SUPERIORITY||LS Mean Difference|-2.76|||<|0.001|TWO_SIDED|95.0|-3.65|-1.87|||ANCOVA|||||-1.87|-3.65|<0.001
91496225|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.416|TWO_SIDED|90.0|-0.5|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.5|0.416
91530731|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0344|||<|0.001|TWO_SIDED|95.0|0.0234|0.0454|||ANOVA|||15 min||0.0454|0.0234|<0.001
91530732|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.029|||<|0.001|TWO_SIDED|95.0|0.018|0.0399|||ANOVA|||30 min||0.0399|0.0180|<0.001
91702465|NCT00772005|183299701|SUPERIORITY_OR_OTHER|||||||0.5859||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5859
91702466|NCT00772005|183299701|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
91702467|NCT00772005|183299702|SUPERIORITY_OR_OTHER|||||||0.2318||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2318
91702468|NCT00772005|183299702|SUPERIORITY_OR_OTHER|||||||0.6211||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6211
91702469|NCT00772005|183299702|SUPERIORITY_OR_OTHER|||||||0.3125||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3125
91702470|NCT00772005|183299703|SUPERIORITY_OR_OTHER|||||||0.2425||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2425
91702471|NCT00772005|183299703|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
91530733|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0169|0.0387|||ANOVA|||1 hour||0.0387|0.0169|<0.001
91530734|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
91530735|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0168|0.0387|||ANOVA|||4 hour||0.0387|0.0168|<0.001
91702472|NCT00772005|183299703|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4753
91702473|NCT00772005|183299704|SUPERIORITY_OR_OTHER|||||||0.1715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1715
91702474|NCT00772005|183299704|SUPERIORITY_OR_OTHER|||||||0.3056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3056
91702475|NCT00772005|183299704|SUPERIORITY_OR_OTHER|||||||0.0083||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0083
91702476|NCT00772005|183299705|SUPERIORITY_OR_OTHER|||||||0.2681||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2681
91702477|NCT00772005|183299705|SUPERIORITY_OR_OTHER|||||||0.1475||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1475
91736080|NCT03235050|183365313|SUPERIORITY||LS Mean Difference|-3.62|||<|0.001|TWO_SIDED|95.0|-4.51|-2.73|||ANCOVA|||||-2.73|-4.51|<0.001
91736081|NCT03235050|183365314|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.92|-0.4|||ANCOVA|||Week 26||-0.40|-0.92|<0.001
91736082|NCT03235050|183365314|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.03|-0.6|||ANCOVA|||Week 26||-0.60|-1.03|<0.001
91736083|NCT03235050|183365314|SUPERIORITY||LS Mean Difference|-0.72|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|||Week 26||-0.51|-0.94|<0.001
91496226|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.634|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.634
91736084|NCT03235050|183365314|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||ANCOVA|||Week 54||-0.24|-0.80|<0.001
91736085|NCT03235050|183365314|SUPERIORITY||LS Mean Difference|-0.63|||<|0.001|TWO_SIDED|95.0|-0.86|-0.39|||ANCOVA|||Week 54||-0.39|-0.86|<0.001
91736086|NCT03235050|183365314|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.34|||ANCOVA|||Week 54||-0.34|-0.80|<0.001
91736087|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|6.67|||<|0.001|TWO_SIDED|92.0|3.34|13.3|||Regression, Logistic|||Week 14||13.30|3.34|<0.001
91736088|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|9.95|||<|0.001|TWO_SIDED|95.0|5.39|18.36|||Regression, Logistic|||Week 14||18.36|5.39|<0.001
91496227|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.47|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.470
91496228|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.683|TWO_SIDED|90.0|-0.5|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.5|0.683
91496229|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.775|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.775
91530736|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0316|||<|0.001|TWO_SIDED|95.0|0.0206|0.0426|||ANOVA|||8 hour||0.0426|0.0206|<0.001
91530737|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0285|||<|0.001|TWO_SIDED|95.0|0.0175|0.0396|||ANOVA|||12 hour||0.0396|0.0175|<0.001
91702478|NCT00772005|183299705|SUPERIORITY_OR_OTHER|||||||0.0647||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0647
91702479|NCT00772005|183299706|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1670
91736089|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|8.52|||<|0.001|TWO_SIDED|95.0|4.65|15.61|||Regression, Logistic|||Week 14||15.61|4.65|<0.001
91702480|NCT00772005|183299706|SUPERIORITY_OR_OTHER|||||||0.1737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1737
91736090|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|3.74|||<|0.001|TWO_SIDED|95.0|1.98|7.03|||Regression, Logistic|||Week 26||7.03|1.98|<0.001
91736091|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|5.4|||<|0.001|TWO_SIDED|95.0|3.13|9.34|||Regression, Logistic|||Week 26||9.34|3.13|<0.001
91736092|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|5.2|||<|0.001|TWO_SIDED|95.0|3.02|8.97|||Regression, Logistic|||Week 26||8.97|3.02|<0.001
91736093|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|4.94|||<|0.001|TWO_SIDED|95.0|2.61|9.36|||Regression, Logistic|||Week 54||9.36|2.61|<0.001
91736094|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|4.55|||<|0.001|TWO_SIDED|95.0|2.62|7.89|||Regression, Logistic|||Week 54||7.89|2.62|<0.001
91736095|NCT03235050|183365315|SUPERIORITY||Odds Ratio, log|4.34|||<|0.001|TWO_SIDED|95.0|2.51|7.51|||Regression, Logistic|||Week 54||7.51|2.51|<0.001
91736096|NCT03235050|183365316|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.32|-0.85|||ANCOVA|||Week 26||-0.85|-3.32|<0.001
91736097|NCT03235050|183365316|SUPERIORITY||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.82|-1.79|||ANCOVA|||Week 26||-1.79|-3.82|<0.001
91736098|NCT03235050|183365316|SUPERIORITY||LS Mean Difference|-3.46|||<|0.001|TWO_SIDED|95.0|-4.48|-2.44|||ANCOVA|||Week 26||-2.44|-4.48|<0.001
91736099|NCT03235050|183365316|SUPERIORITY||LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.86|-1.0|||ANCOVA|||Week 54||-1.00|-3.86|<0.001
91736100|NCT03235050|183365316|SUPERIORITY||LS Mean Difference|-2.24|||<|0.001|TWO_SIDED|95.0|-3.41|-1.06|||ANCOVA|||Week 54||-1.06|-3.41|<0.001
91736101|NCT03235050|183365316|SUPERIORITY||LS Mean Difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.49|-2.14|||ANCOVA|||Week 54||-2.14|-4.49|<0.001
91736102|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-1.95|||<|0.001|TWO_SIDED|95.0|-3.03|-0.87|||ANCOVA|||Week 14||-0.87|-3.03|<0.001
91736103|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-2.75|||<|0.001|TWO_SIDED|95.0|-3.63|-1.86|||ANCOVA|||Week 14||-1.86|-3.63|<0.001
91736104|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-3.71|||<|0.001|TWO_SIDED|95.0|-4.6|-2.82|||ANCOVA|||Week 14||-2.82|-4.60|<0.001
91736105|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-2.01||||0.002|TWO_SIDED|95.0|-3.27|-0.74|||ANCOVA|||Week 26||-0.74|-3.27|0.002
91736106|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.78|-1.71|||ANCOVA|||Week 26||-1.71|-3.78|<0.001
91736107|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-3.55|||<|0.001|TWO_SIDED|95.0|-4.59|-2.52|||ANCOVA|||Week 26||-2.52|-4.59|<0.001
91736108|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-2.27||||0.003|TWO_SIDED|95.0|-3.74|-0.79|||ANCOVA|||Week 54||-0.79|-3.74|0.003
91736109|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-2.16|||<|0.001|TWO_SIDED|95.0|-3.37|-0.95|||ANCOVA|||Week 54||-0.95|-3.37|<0.001
91702481|NCT00772005|183299706|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3720
91530738|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0281|||<|0.001|TWO_SIDED|95.0|0.0167|0.0394|||ANOVA|||23 hour 15 min||0.0394|0.0167|<0.001
91530739|NCT03257995|182937507|OTHER||Mean Difference (Final Values)|0.0266|||<|0.001|TWO_SIDED|95.0|0.0152|0.0379|||ANOVA|||23 hour 45 min||0.0379|0.0152|<0.001
91702482|NCT00772005|183299707|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
91702483|NCT00772005|183299707|SUPERIORITY_OR_OTHER|||||||0.6043||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6043
91702484|NCT00772005|183299707|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0463
91702485|NCT00772005|183299708|SUPERIORITY_OR_OTHER|||||||0.9258||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9258
91530740|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2025|||<|0.001|TWO_SIDED|95.0|0.1059|0.2952|||ANOVA|||5 min||0.2952|0.1059|<0.001
91530741|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2923|||<|0.001|TWO_SIDED|95.0|0.1979|0.3867|||ANOVA|||15 min||0.3867|0.1979|<0.001
91702486|NCT00772005|183299708|SUPERIORITY_OR_OTHER|||||||0.9116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9116
91530742|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2657|||<|0.001|TWO_SIDED|95.0|0.1713|0.3601|||ANOVA|||30 min||0.3601|0.1713|<0.001
91702487|NCT00772005|183299708|SUPERIORITY_OR_OTHER|||||||0.4848||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4848
91702488|NCT00772005|183299709|SUPERIORITY_OR_OTHER|||||||0.7612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7612
91702489|NCT00772005|183299709|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5761
91702490|NCT00772005|183299709|SUPERIORITY_OR_OTHER|||||||0.1576||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1576
91702491|NCT00772005|183299710|SUPERIORITY_OR_OTHER|||||||0.9565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9565
91702492|NCT00772005|183299710|SUPERIORITY_OR_OTHER|||||||0.9178||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9178
91702493|NCT00772005|183299710|SUPERIORITY_OR_OTHER|||||||0.1491||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1491
91702494|NCT00772005|183299711|SUPERIORITY_OR_OTHER|||||||0.7056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7056
91702495|NCT00772005|183299711|SUPERIORITY_OR_OTHER|||||||0.5179||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5179
91702496|NCT00772005|183299711|SUPERIORITY_OR_OTHER|||||||0.4585||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4585
91736110|NCT03235050|183365317|SUPERIORITY||LS Mean Difference|-3.42|||<|0.001|TWO_SIDED|95.0|-4.63|-2.2|||ANCOVA|||Week 54||-2.20|-4.63|<0.001
91736111|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|0.7||||0.211|TWO_SIDED|95.0|-0.39|1.79|||ANCOVA|||Percent change at Week 14||1.79|-0.39|0.211
91702497|NCT00772005|183299712|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0690
91702498|NCT00772005|183299712|SUPERIORITY_OR_OTHER|||||||0.5324||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5324
91702499|NCT00772005|183299712|SUPERIORITY_OR_OTHER|||||||0.0946||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0946
91702500|NCT00772005|183299713|SUPERIORITY_OR_OTHER|||||||0.1878||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1878
91702501|NCT00772005|183299713|SUPERIORITY_OR_OTHER|||||||0.4294||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4294
91702502|NCT00772005|183299713|SUPERIORITY_OR_OTHER|||||||0.6504||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6504
91702503|NCT00772005|183299714|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4022
91530743|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2752|||<|0.001|TWO_SIDED|95.0|0.1808|0.3696|||ANOVA|||1 hour||0.3696|0.1808|<0.001
91736112|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|-0.07||||0.881|TWO_SIDED|95.0|-0.96|0.83|||ANCOVA|||Percent change at Week 14||0.83|-0.96|0.881
91736113|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|-0.93||||0.042|TWO_SIDED|95.0|-1.82|-0.04|||ANCOVA|||Percent change at Week 14||-0.04|-1.82|0.042
91736114|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|0.9||||0.158|TWO_SIDED|95.0|-0.35|2.14|||ANCOVA|||Percent change at Week 26||2.14|-0.35|0.158
91496230|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.848|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.848
91530744|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2819|||<|0.001|TWO_SIDED|95.0|0.1875|0.3763|||ANOVA|||2 hours||0.3763|0.1875|<0.001
91736115|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|0.18||||0.734|TWO_SIDED|95.0|-0.85|1.2|||ANCOVA|||Percent change at Week 26||1.20|-0.85|0.734
91736116|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|-0.48||||0.357|TWO_SIDED|95.0|-1.51|0.54|||ANCOVA|||Percent change at Week 26||0.54|-1.51|0.357
91736117|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|-0.07||||0.921|TWO_SIDED|95.0|-1.51|1.37|||ANCOVA|||Percent change at Week 54||1.37|-1.51|0.921
91736118|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|0.12||||0.847|TWO_SIDED|95.0|-1.07|1.3|||ANCOVA|||Percent change at Week 54||1.30|-1.07|0.847
91736119|NCT03235050|183365318|SUPERIORITY||LS Mean Difference|-0.96||||0.112|TWO_SIDED|95.0|-2.15|0.22|||ANCOVA|||Percent change at Week 54||0.22|-2.15|0.112
91736120|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|0.59||||0.284|TWO_SIDED|95.0|-0.49|1.68|||ANCOVA|||Absolute change at Week 14||1.68|-0.49|0.284
91530745|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.282|||<|0.001|TWO_SIDED|95.0|0.1874|0.3766|||ANOVA|||4 hours||0.3766|0.1874|<0.001
91530746|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2538|||<|0.001|TWO_SIDED|95.0|0.1585|0.3492|||ANOVA|||8 hours||0.3492|0.1585|<0.001
91530747|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2687|||<|0.001|TWO_SIDED|95.0|0.1732|0.3643|||ANOVA|||12 hours||0.3643|0.1732|<0.001
91530748|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2453|||<|0.001|TWO_SIDED|95.0|0.1473|0.3434|||ANOVA|||23 hours 15 min||0.3434|0.1473|<0.001
91736121|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-0.2||||0.658|TWO_SIDED|95.0|-1.09|0.69|||ANCOVA|||Absolute change at Week 14||0.69|-1.09|0.658
91736122|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-1.17||||0.01|TWO_SIDED|95.0|-2.06|-0.27|||ANCOVA|||Absolute change at Week 14||-0.27|-2.06|0.010
91736123|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|0.7||||0.279|TWO_SIDED|95.0|-0.57|1.97|||ANCOVA|||Absolute change at Week 26||1.97|-0.57|0.279
91736124|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-0.04||||0.94|TWO_SIDED|95.0|-1.08|1.0|||ANCOVA|||Absolute change at Week 26||1.00|-1.08|0.940
91736125|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-0.85||||0.11|TWO_SIDED|95.0|-1.89|0.19|||ANCOVA|||Absolute change at Week 26||0.19|-1.89|0.110
91736126|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-0.26||||0.73|TWO_SIDED|95.0|-1.74|1.22|||ANCOVA|||Absolute change at Week 54||1.22|-1.74|0.730
91736127|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-0.15||||0.804|TWO_SIDED|95.0|-1.38|1.07|||ANCOVA|||Absolute change at Week 54||1.07|-1.38|0.804
91736128|NCT03235050|183365319|SUPERIORITY||LS Mean Difference|-1.41||||0.023|TWO_SIDED|95.0|-2.63|-0.19|||ANCOVA|||Absolute change at Week 54||-0.19|-2.63|0.023
91736129|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|8.37|||<|0.001|TWO_SIDED|95.0|2.38|29.43|||Regression, Logistic|||weight loss \>=5% at Week 14||29.43|2.38|<0.001
91736130|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|12.46|||<|0.001|TWO_SIDED|95.0|3.82|40.64|||Regression, Logistic|||weight loss \>=5% at Week 14||40.64|3.82|<0.001
91530749|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.1862|||<|0.001|TWO_SIDED|95.0|0.0882|0.2842|||ANOVA|||23 hours 45 min||0.2842|0.0882|<0.001
91530750|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.1956|||<|0.001|TWO_SIDED|95.0|0.1012|0.2899|||ANOVA|||5 min||0.2899|0.1012|<0.001
91530751|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2927|||<|0.001|TWO_SIDED|95.0|0.1979|0.3875|||ANOVA|||15 min||0.3875|0.1979|<0.001
91530752|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2723|||<|0.001|TWO_SIDED|95.0|0.178|0.3667|||ANOVA|||30 min||0.3667|0.1780|<0.001
91530753|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2386|||<|0.001|TWO_SIDED|95.0|0.1445|0.3328|||ANOVA|||1 hour||0.3328|0.1445|<0.001
91736131|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|21.26|||<|0.001|TWO_SIDED|95.0|6.55|68.97|||Regression, Logistic|||weight loss \>=5% at Week 14||68.97|6.55|<0.001
91736132|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|3.68|||<|0.001|TWO_SIDED|95.0|1.72|7.89|||Regression, Logistic|||weight loss \>=5% at Week 26||7.89|1.72|<0.001
91736133|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|3.95|||<|0.001|TWO_SIDED|95.0|2.0|7.78|||Regression, Logistic|||weight loss \>=5% at Week 26||7.78|2.00|<0.001
91736134|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|7.28|||<|0.001|TWO_SIDED|95.0|3.72|14.24|||Regression, Logistic|||weight loss \>=5% at Week 26||14.24|3.72|<0.001
91736135|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|3.71|||<|0.001|TWO_SIDED|95.0|1.84|7.45|||Regression, Logistic|||weight loss \>=5% at Week 54||7.45|1.84|<0.001
91736136|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|2.73||||0.002|TWO_SIDED|95.0|1.46|5.09|||Regression, Logistic|||weight loss \>=5% at Week 54||5.09|1.46|0.002
91736137|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|4.48|||<|0.001|TWO_SIDED|95.0|2.42|8.3|||ANCOVA|||weight loss \>=5% at Week 54||8.30|2.42|<0.001
91736138|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|8.47||||0.048|TWO_SIDED|95.0|1.02|70.17|||Regression, Logistic|||weight loss \>=10% at Week 26||70.17|1.02|0.048
91736139|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|13.81||||0.01|TWO_SIDED|95.0|1.85|102.91|||Regression, Logistic|||weight loss \>=10% at Week 26||102.91|1.85|0.010
91736140|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|13.09||||0.012|TWO_SIDED|95.0|1.75|97.68|||Regression, Logistic|||weight loss \>=10% at Week 26||97.68|1.75|0.012
91736141|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|6.92||||0.013|TWO_SIDED|95.0|1.49|32.07|||Regression, Logistic|||weight loss \>=10% at Week 54||32.07|1.49|0.013
91736142|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|4.98||||0.032|TWO_SIDED|95.0|1.15|21.6|||Regression, Logistic|||weight loss \>=10% at Week 54||21.60|1.15|0.032
91736143|NCT03235050|183365320|SUPERIORITY||Odds Ratio, log|7.91||||0.005|TWO_SIDED|95.0|1.86|33.64|||Regression, Logistic|||weight loss \>=10% at Week 54||33.64|1.86|0.005
91736144|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.09||||0.024|TWO_SIDED|95.0|0.01|0.73|||Regression, Logistic|||received rescue medication at 14 wks||0.73|0.01|0.024
91496231|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.23||0.49|TWO_SIDED|90.0|-0.2|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-0.2|0.490
91496232|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.433|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.433
91530754|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2986|||<|0.001|TWO_SIDED|95.0|0.2042|0.393|||ANOVA|||2 hours||0.3930|0.2042|<0.001
91702504|NCT00772005|183299714|SUPERIORITY_OR_OTHER|||||||0.6246||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6246
91702505|NCT00772005|183299714|SUPERIORITY_OR_OTHER|||||||0.8655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8655
91702506|NCT00772005|183299715|SUPERIORITY_OR_OTHER|||||||0.5676||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5676
91702507|NCT00772005|183299715|SUPERIORITY_OR_OTHER|||||||0.5239||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5239
91702508|NCT00772005|183299715|SUPERIORITY_OR_OTHER|||||||0.4092||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4092
91702509|NCT00772005|183299716|SUPERIORITY_OR_OTHER|||||||0.5195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5195
91702510|NCT00772005|183299716|SUPERIORITY_OR_OTHER|||||||0.1732||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1732
91702511|NCT00772005|183299716|SUPERIORITY_OR_OTHER|||||||0.7455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7455
91702512|NCT00772005|183299717|SUPERIORITY_OR_OTHER|||||||0.6885||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6885
91702513|NCT00772005|183299717|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5443
91702514|NCT00772005|183299717|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9343
91736145|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.03|0.4|||Regression, Logistic|||received rescue medication at 14 wks||0.40|0.03|<0.001
91736146|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.33|||Regression, Logistic|||received rescue medication at 14 wks||0.33|0.02|<0.001
91736147|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.14||||0.002|TWO_SIDED|95.0|0.04|0.48|||Regression, Logistic|||received rescue medication at 26 wks||0.48|0.04|0.002
91736148|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.34|||Regression, Logistic|||received rescue medication at 26 wks||0.34|0.06|<0.001
91736149|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.28|||Regression, Logistic|||received rescue medication at 26 wks||0.28|0.04|<0.001
91736150|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.11|0.53|||Regression, Logistic|||received rescue medication at 54 wks||0.53|0.11|<0.001
91736151|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||received rescue medication at 54 wks||0.44|0.13|<0.001
91736152|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.41|||Regression, Logistic|||received rescue medication at 54 wks||0.41|0.12|<0.001
91736153|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.22||||0.216|TWO_SIDED|95.0|0.02|2.43|||Regression, Logistic|||discontinued IP at 14 wks||2.43|0.02|0.216
91736154|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.28||||0.253|TWO_SIDED|95.0|0.03|2.52|||Regression, Logistic|||discontinued IP at 26 wks||2.52|0.03|0.253
91736155|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.21||||0.079|TWO_SIDED|95.0|0.04|1.19|||Regression, Logistic|||discontinued IP at 26 wks||1.19|0.04|0.079
91736156|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.27||||0.252|TWO_SIDED|95.0|0.03|2.5|||Regression, Logistic|||discontinued IP at 54 wks||2.50|0.03|0.252
91736157|NCT03235050|183365321|SUPERIORITY||Odds Ratio, log|0.32||||0.143|TWO_SIDED|95.0|0.07|1.47|||Regression, Logistic|||discontinued IP at 54 wks||1.47|0.07|0.143
91736158|NCT00370292|183365325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91496233|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.796|TWO_SIDED|90.0|-0.4|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.4|0.796
91496234|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.624|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.624
91496235|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.844|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.844
91530755|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2661|||<|0.001|TWO_SIDED|95.0|0.1715|0.3607|||ANOVA|||4 hours||0.3607|0.1715|<0.001
91736159|NCT00370292|183365325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736160|NCT00370292|183365325|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.030
91736161|NCT00370292|183365325|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.166
91496236|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.5||0.743|TWO_SIDED|90.0|-0.7|1.0|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.7|0.743
91496237|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.356|TWO_SIDED|90.0|-1.3|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.3|0.356
91530756|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2558|||<|0.001|TWO_SIDED|95.0|0.1609|0.3506|||ANOVA|||8 hours||0.3506|0.1609|<0.001
91530757|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.1987|||<|0.001|TWO_SIDED|95.0|0.1036|0.2938|||ANOVA|||12 hours||0.2938|0.1036|<0.001
91530758|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.2044|||<|0.001|TWO_SIDED|95.0|0.1071|0.3017|||ANOVA|||23 hours 15 min||0.3017|0.1071|<0.001
91702515|NCT00772005|183299718|SUPERIORITY_OR_OTHER|||||||0.9093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9093
91702516|NCT00772005|183299718|SUPERIORITY_OR_OTHER|||||||0.4701||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4701
91736162|NCT00370292|183365325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736163|NCT00370292|183365325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736164|NCT00370292|183365327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736165|NCT00370292|183365327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736166|NCT00370292|183365327|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.333
91736167|NCT00370292|183365327|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.849
91736168|NCT00370292|183365327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736169|NCT00370292|183365327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
91736170|NCT03545672|183365328|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.001
91736171|NCT03545672|183365329|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91530759|NCT03257995|182937508|OTHER||Mean Difference (Final Values)|0.1997|||<|0.001|TWO_SIDED|95.0|0.1023|0.297|||ANOVA|||23 hours 45 min||0.2970|0.1023|<0.001
91530760|NCT03257995|182937509|OTHER||Mean Difference (Final Values)|0.2476|||<|0.001|TWO_SIDED|95.0|0.1857|0.3095|||ANOVA|||||0.3095|0.1857|<.001
91530761|NCT03257995|182937509|OTHER||Mean Difference (Final Values)|0.2448|||<|0.001|TWO_SIDED|95.0|0.183|0.3066|||ANOVA|||||0.3066|0.1830|<.001
91530762|NCT03257995|182937509|OTHER||Mean Difference (Net)|-0.0028|||||TWO_SIDED|95.0|-0.0647|0.059|||ANOVA|||||0.0590|-0.0647|
91760045|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.05|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.05|
91530763|NCT03257995|182937510|OTHER||Mean Difference (Final Values)|-0.42||||0.009|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.009
91736172|NCT02415556|183365330|OTHER|"A spatial power variance-covariance structure was used to model within-subject correlated measurements where the number of days from the baseline visit was used as the power of the autoregressive correlation coefficient. Each efficacy and safety outcome variable was modeled separately.~The independent variables included: 4 treatment groups, TIMEG (baseline, on-treatment and post-treatment period), TIMEG \* treatment group.; an average number of treatment days; subjects as random effects."|Mean Difference (Final Values)|6.52||||0.025|TWO_SIDED|95.0|0.81|12.23||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||12.23|0.81|0.025
91736173|NCT02415556|183365330|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|5.28||||0.051|TWO_SIDED|95.0|-0.03|10.6||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||10.60|-0.03|0.051
91736174|NCT02415556|183365331|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|8.31||||0.007|TWO_SIDED|95.0|2.33|14.29||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||14.29|2.33|0.007
91736175|NCT02415556|183365331|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|2.71||||0.342|TWO_SIDED|95.0|-2.9|8.32||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||8.32|-2.90|0.342
91736176|NCT02415556|183365332|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.37||||0.144|TWO_SIDED|95.0|-0.87|0.13||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.13|-0.87|0.144
91702517|NCT00772005|183299718|SUPERIORITY_OR_OTHER|||||||0.9764||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9764
91702518|NCT00772005|183299719|SUPERIORITY_OR_OTHER|||||||0.8115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8115
91702519|NCT00772005|183299719|SUPERIORITY_OR_OTHER|||||||0.5378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5378
91702520|NCT00772005|183299719|SUPERIORITY_OR_OTHER|||||||0.9144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9144
91702521|NCT00772005|183299720|SUPERIORITY_OR_OTHER|||||||0.9812||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9812
91702522|NCT00772005|183299720|SUPERIORITY_OR_OTHER|||||||0.5464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5464
91496238|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|90.0|-0.2|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-0.2|0.180
91530764|NCT03257995|182937510|OTHER||Mean Difference (Final Values)|-0.42||||0.008|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.008
91702523|NCT00772005|183299720|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8811
91702524|NCT00772005|183299721|SUPERIORITY_OR_OTHER|||||||0.6487||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6487
91702525|NCT00772005|183299721|SUPERIORITY_OR_OTHER|||||||0.4204||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4204
91702526|NCT00772005|183299721|SUPERIORITY_OR_OTHER|||||||0.6955||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6955
91702527|NCT00772005|183299722|SUPERIORITY_OR_OTHER|||||||0.6042||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6042
91702528|NCT00772005|183299722|SUPERIORITY_OR_OTHER|||||||0.9783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9783
91702529|NCT00772005|183299722|SUPERIORITY_OR_OTHER|||||||0.9739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9739
91702530|NCT00772005|183299723|SUPERIORITY_OR_OTHER|||||||0.3466||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3466
91702531|NCT00772005|183299723|SUPERIORITY_OR_OTHER|||||||0.8469||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8469
91702532|NCT00772005|183299723|SUPERIORITY_OR_OTHER|||||||0.5439||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5439
91702533|NCT00772005|183299724|SUPERIORITY_OR_OTHER|||||||0.6059||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6059
91702534|NCT00772005|183299724|SUPERIORITY_OR_OTHER|||||||0.7474||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7474
91702535|NCT00772005|183299724|SUPERIORITY_OR_OTHER|||||||0.4424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4424
91702536|NCT00772005|183299725|SUPERIORITY_OR_OTHER|||||||0.4874||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4874
91702537|NCT00772005|183299725|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8243
91702538|NCT00772005|183299725|SUPERIORITY_OR_OTHER|||||||0.9562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9562
91702539|NCT00772005|183299726|SUPERIORITY_OR_OTHER|||||||0.3686||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3686
91702540|NCT00772005|183299726|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0270
91760046|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.06|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.06|
91530765|NCT03257995|182937511|OTHER||Mean Difference (Final Values)|33.0|||<|0.001|TWO_SIDED|95.0|25.6|40.3|||ANOVA|||||40.3|25.6|<0.001
91736177|NCT02415556|183365332|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.64||||0.008|TWO_SIDED|95.0|-1.11|-0.16||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||-0.16|-1.11|0.008
91736178|NCT02415556|183365333|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.149|TWO_SIDED|95.0|-0.13|0.83||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.83|-0.13|0.149
91736179|NCT02415556|183365333|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.8||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.80|-0.11|0.134
91736180|NCT02415556|183365334|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|10.29||||0.03|TWO_SIDED|95.0|1.0|19.58|||Mixed Models Analysis|||||19.58|1.00|0.030
91496239|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.589|TWO_SIDED|90.0|-0.6|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-0.6|0.589
91496240|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.873|TWO_SIDED|90.0|-0.8|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.8|0.873
91496241|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.667|TWO_SIDED|90.0|-0.6|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.6|0.667
91496242|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.548|TWO_SIDED|90.0|-0.5|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.5|0.548
91496243|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.567|TWO_SIDED|90.0|-1.0|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-1.0|0.567
91496244|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.208|TWO_SIDED|90.0|-0.2|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.2|0.208
91496245|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.858|TWO_SIDED|90.0|-1.2|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.2|0.858
91496246|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.329|TWO_SIDED|90.0|-1.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-1.7|0.329
91530766|NCT03257995|182937511|OTHER||Mean Difference (Final Values)|30.8|||<|0.001|TWO_SIDED|95.0|23.5|38.2|||ANOVA|||||38.2|23.5|<0.001
91736181|NCT02415556|183365334|OTHER|See primary aims.|Mean Difference (Final Values)|2.21||||0.607|TWO_SIDED|95.0|-6.22|10.63||See primary aims.|Mixed Models Analysis|||See primary aims.||10.63|-6.22|0.607
91736182|NCT02415556|183365335|OTHER|See primary aims.|Mean Difference (Final Values)|-2.1||||0.576|TWO_SIDED|95.0|-9.5|5.29||See primary aims.|Mixed Models Analysis|||See primary aims.||5.29|-9.50|0.576
91496247|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.272|TWO_SIDED|90.0|-0.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.4|0.272
91496248|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.946|TWO_SIDED|90.0|-0.6|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.6|0.946
91496249|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.407|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.3|-0.8|0.407
91496250|NCT02310568|182864234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.436|TWO_SIDED|90.0|-0.3|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.8|-0.3|0.436
91736183|NCT02415556|183365335|OTHER|See primary aims.|Mean Difference (Final Values)|-0.86||||0.802|TWO_SIDED|95.0|-7.58|5.87||See primary aims.|Mixed Models Analysis|||See primary aims.||5.87|-7.58|0.802
91736184|NCT02415556|183365336|EQUIVALENCE|CBF and vasoreactivity maps were analyzed on a voxel-by-voxel basis using Statistical non-Parametric Mapping (SnPM, http://www.sph.umich.edu/ni-stat/SnPM/), voxel-level threshold p \< 0.005.||||||0.03|||||||Voxel-Based Morphometry|||||||0.03
91736185|NCT01621178|183365340|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.26|0.15|||Mixed Models Analysis|||Week 26||0.15|-0.26|<0.001
91736186|NCT01621178|183365340|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.18|0.22|||Mixed Models Analysis|||Week 26||0.22|-0.18|<0.001
91736187|NCT02465931|183365369|OTHER|||||||0.89|||||||t-test, 1 sided|||||||0.89
91736188|NCT04790786|183365379|EQUIVALENCE|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||||||||||||Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound based on Bayesian probability.|Bayesian cumulative logistic model|Bayesian cumulative logistic model, Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||The primary analysis model was a Bayesian cumulative logistic model that adjusted for treatment location (infusion center or ED), age (\<30, 30-39, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years), sex, and time (2-week epochs). Comparisons between individual mAb were based on the relative odds ratio between a given two arms for the primary outcome. An odds ratio for an arm to a comparator \>1 implies improved outcomes. A sliding scale with different levels of equivalence bounds was pre-defined|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.|||
91736189|NCT04102007|183365392|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 16|57.4|||||TWO_SIDED|95.0|51.1|63.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||63.4|51.1|
91736190|NCT04102007|183365393|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 16|20.5|||||TWO_SIDED|95.0|15.4|26.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.0|15.4|
91736191|NCT04102007|183365394|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 16|40.2|||||TWO_SIDED|95.0|34.2|46.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||46.4|34.2|
91736192|NCT04102007|183365395|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 16|20.9|||||TWO_SIDED|95.0|16.3|26.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.4|16.3|
91736193|NCT04102007|183365396|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 52|62.3|||||TWO_SIDED|95.0|56.0|68.1|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||68.1|56.0|
91736194|NCT04102007|183365397|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 52|27.1|||||TWO_SIDED|95.0|21.9|33.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.0|21.9|
91736195|NCT04102007|183365398|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 52|47.2|||||TWO_SIDED|95.0|41.0|53.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||53.4|41.0|
91736196|NCT04102007|183365399|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 52|27.5|||||TWO_SIDED|95.0|22.3|33.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.4|22.3|
91702541|NCT00772005|183299726|SUPERIORITY_OR_OTHER|||||||0.7322||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7322
91736197|NCT03289143|183365402|SUPERIORITY|||||||0.6147||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6147
91736198|NCT03289143|183365402|SUPERIORITY|||||||0.5778||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5778
91736199|NCT03289143|183365402|SUPERIORITY|||||||0.5136||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5136
91736200|NCT03289143|183365404|SUPERIORITY|||||||0.8198||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.8198
91736201|NCT03289143|183365404|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
91736202|NCT03289143|183365404|SUPERIORITY|||||||0.6043||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6043
91736203|NCT03289143|183365405|SUPERIORITY|||||||0.0783||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.0783
91736204|NCT03289143|183365405|SUPERIORITY|||||||0.601||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6010
91736205|NCT03289143|183365405|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
91736206|NCT03289143|183365406|SUPERIORITY|||||||0.9749||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.9749
91736207|NCT03289143|183365406|SUPERIORITY|||||||0.7718||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7718
91736208|NCT03289143|183365406|SUPERIORITY|||||||0.5789||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5789
91736209|NCT03289143|183365407|SUPERIORITY|||||||0.5235||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5235
91496251|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.325|TWO_SIDED|90.0|-0.6|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.1|-0.6|0.325
91496252|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.996|TWO_SIDED|90.0|-0.3|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.3|0.996
91702542|NCT00772005|183299727|SUPERIORITY_OR_OTHER|||||||0.4646||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4646
91736210|NCT03289143|183365407|SUPERIORITY|||||||0.5612||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5612
91736211|NCT03289143|183365407|SUPERIORITY|||||||0.713||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7130
91736212|NCT00730756|183365419|SUPERIORITY_OR_OTHER|||||||0.845||95.0|||||ANCOVA|Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.||||||0.845
91736213|NCT05067335|183365489|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|9.37|STANDARD_ERROR_OF_MEAN|0.524|<|0.001|TWO_SIDED|95.0|8.34|10.39|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||10.39|8.34|<0.001
91702543|NCT00772005|183299727|SUPERIORITY_OR_OTHER|||||||0.8783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8783
91736214|NCT05067335|183365492|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|2.86|STANDARD_ERROR_OF_MEAN|0.348|<|0.001|TWO_SIDED|95.0|2.18|3.54|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||3.54|2.18|<0.001
91736215|NCT05067335|183365493|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|3.48|STANDARD_ERROR_OF_MEAN|0.458|<|0.001|TWO_SIDED|95.0|2.58|4.38|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||4.38|2.58|<0.001
91736216|NCT02136914|183365498|SUPERIORITY||Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.3||0.0009|TWO_SIDED|95.0|-12.5|-3.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-3.3|-12.5|0.0009
91736217|NCT02136914|183365499|SUPERIORITY||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|2.7||0.0008|TWO_SIDED|95.0|-14.7|-4.0|||Linear Mixed Model w/ Repeated Measures|||||-4.0|-14.7|0.0008
91736218|NCT02136914|183365500|SUPERIORITY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|0.612|<|0.0001|TWO_SIDED|95.0|1.53|3.96||Change from Baseline in ON time without troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||3.96|1.53|<0.0001
91736219|NCT02136914|183365500|SUPERIORITY||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.634||0.0007|TWO_SIDED|95.0|0.96|3.47||Change from Baseline in ON time without troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||3.47|0.96|0.0007
91736220|NCT02136914|183365500|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.0171|TWO_SIDED|95.0|-1.64|-0.16||Change from Baseline in OFF time at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.16|-1.64|0.0171
91736221|NCT02136914|183365500|SUPERIORITY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0406|TWO_SIDED|95.0|-1.58|-0.04||Change from Baseline in OFF time at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.04|-1.58|0.0406
91736222|NCT02136914|183365500|SUPERIORITY||Least Squares Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.508||0.0031|TWO_SIDED|95.0|-2.55|-0.53||Change from Baseline in ON time with troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.53|-2.55|0.0031
91496253|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.377|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.377
91496254|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.291|TWO_SIDED|90.0|-0.7|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-0.7|0.291
91496255|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.925|TWO_SIDED|90.0|-0.4|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.4|0.925
91496256|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.39|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.390
91496257|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.502|TWO_SIDED|90.0|-0.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.7|0.502
91496258|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.348|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.348
91496259|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.16|TWO_SIDED|90.0|-1.0|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-1.0|0.160
91496260|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.965|TWO_SIDED|90.0|-0.5|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.5|0.965
91496261|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.389|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.389
91496262|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.433|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.8|0.433
91530767|NCT01374802|182937555|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.29|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|101.36|131.13|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||131.13|101.36|
91530768|NCT01374802|182937556|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|87.91|STANDARD_DEVIATION|38.3|||TWO_SIDED|90.0|68.609|112.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||112.630|68.609|
91530769|NCT01374802|182937557|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|128.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|115.724|142.489|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||142.489|115.724|
91496263|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|90.0|-0.9|0.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-0.9|0.940
91702544|NCT00772005|183299727|SUPERIORITY_OR_OTHER|||||||0.4213||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4213
91702545|NCT00772005|183299728|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
91702546|NCT00772005|183299728|SUPERIORITY_OR_OTHER|||||||0.0262||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0262
91702547|NCT00772005|183299728|SUPERIORITY_OR_OTHER|||||||0.6652||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6652
91736223|NCT02136914|183365500|SUPERIORITY||Least Squares Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.526||0.0072|TWO_SIDED|95.0|-2.49|-0.4||Change from Baseline in ON time with troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.40|-2.49|0.0072
91736224|NCT02136914|183365501|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.74||0.6833|TWO_SIDED|95.0|-6.6|4.3||Change from Baseline in MDS-UPDRS at Week 12.|Linear Mixed Model w/ Repeated Measures|||||4.3|-6.6|0.6833
91736225|NCT02136914|183365501|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.58||0.5557|TWO_SIDED|95.0|-5.0|9.2||Change from Baseline in MDS-UPDRS at Week 24.|Linear Mixed Model w/ Repeated Measures|||||9.2|-5.0|0.5557
91736226|NCT02136914|183365502|SUPERIORITY||||||<|0.0001||||||Baseline to Week 12|Cochran-Mantel-Haenszel|||||||<0.0001
91736227|NCT02136914|183365502|SUPERIORITY|||||||0.1071||||||Baseline to Week 24|Cochran-Mantel-Haenszel|||||||0.1071
91736228|NCT00560417|183365528|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was prespecified at 0.4%|Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|0.06|0.38|||ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group.||||0.38|0.06|
91736229|NCT00560417|183365529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 weeks.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
91736230|NCT00560417|183365529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF)|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.38|0.06|0.008
91736231|NCT00560417|183365530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 Weeks change.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
91736232|NCT00560417|183365530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF) Change.|ANCOVA|||||0.38|0.06|0.008
91736233|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||p-value is for Week 12: HbA1c \<7.0%|Fisher Exact|||||||0.561
91736234|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Week 12: HbA1c \<=6.5%|Fisher Exact|||||||0.511
91496264|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.757|TWO_SIDED|90.0|-1.0|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-1.0|0.757
91736235|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||p-value is for Week 18: HbA1c \<7.0%|Fisher Exact|||||||0.012
91736236|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value is for Week 18: HbA1c \<=6.5%|Fisher Exact|||||||0.269
91530770|NCT01370603|182937564|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.|Difference in Least-squares means|-0.2|||||TWO_SIDED|97.5|-1.9|1.4|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.||1.4|-1.9|
91736237|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||p-value is for Week 24: HbA1c \<7.0%|Fisher Exact|||||||0.161
91736238|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||p-value is for Week 24: HbA1c \<=6.5%|Fisher Exact|||||||0.071
91496265|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.836|TWO_SIDED|90.0|-0.7|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-0.7|0.836
91736239|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||p-value is for Endpoint (LOCF): HbA1c \<7.0%|Fisher Exact|||||||0.177
91736240|NCT00560417|183365531|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Endpoint (LOCF): HbA1c \<=6.5%|Fisher Exact|||||||0.060
91736241|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.28||||0.179|TWO_SIDED|95.0|-1.97|10.53||p-value is for Endpoint Morning Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||10.53|-1.97|0.179
91736242|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|||<|0.001|TWO_SIDED|95.0|5.72|22.19||p-value is for Endpoint Morning Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.19|5.72|<0.001
91736243|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.325|TWO_SIDED|95.0|-3.79|11.39||p-value is for Endpoint Midday Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||11.39|-3.79|0.325
91736244|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.73||||0.051|TWO_SIDED|95.0|-0.04|17.5||p-value is for Endpoint Midday Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||17.50|-0.04|0.051
91736245|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.92||||0.003|TWO_SIDED|95.0|3.66|18.19||p-value is for Endpoint Evening Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.19|3.66|0.003
91736246|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.19||||0.002|TWO_SIDED|95.0|5.44|22.94||p-value is for Endpoint Evening Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.94|5.44|0.002
91736247|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.03||||0.415|TWO_SIDED|95.0|-10.35|4.28||p-value is for Endpoint 0300 Hours.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||4.28|-10.35|0.415
91496266|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.827|TWO_SIDED|90.0|-0.9|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.9|0.827
91496267|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.507|TWO_SIDED|90.0|-0.6|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.6|0.507
91496268|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.632
91496269|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.51||0.442|TWO_SIDED|90.0|-0.5|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.5|0.442
91496270|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.643|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.643
91496271|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.47||0.188|TWO_SIDED|90.0|-0.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.2|0.188
91496272|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.701|TWO_SIDED|90.0|-1.4|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.4|0.701
91496273|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63||0.271|TWO_SIDED|90.0|-1.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.8|0.271
91702548|NCT00772005|183299729|SUPERIORITY_OR_OTHER|||||||0.3355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3355
91702549|NCT00772005|183299729|SUPERIORITY_OR_OTHER|||||||0.0953||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0953
91702550|NCT00772005|183299729|SUPERIORITY_OR_OTHER|||||||0.9235||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9235
91702551|NCT00772005|183299730|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4164
91702552|NCT00772005|183299730|SUPERIORITY_OR_OTHER|||||||0.3003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3003
91702553|NCT00772005|183299730|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6907
91702554|NCT00772005|183299731|SUPERIORITY_OR_OTHER|||||||0.2518||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2518
91702555|NCT00772005|183299731|SUPERIORITY_OR_OTHER|||||||0.0739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0739
91702556|NCT00772005|183299731|SUPERIORITY_OR_OTHER|||||||0.5644||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5644
91702557|NCT00772005|183299732|SUPERIORITY_OR_OTHER|||||||0.4305||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4305
91702558|NCT00772005|183299732|SUPERIORITY_OR_OTHER|||||||0.8299||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8299
91496274|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.445|TWO_SIDED|90.0|-0.6|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.6|0.445
91496275|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.714|TWO_SIDED|90.0|-0.8|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.8|0.714
91496276|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|90.0|-0.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.4|-0.8|0.515
91496277|NCT02310568|182864235|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.778|TWO_SIDED|90.0|-0.5|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.7|-0.5|0.778
91496278|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.93||0.562|TWO_SIDED|90.0|-2.1|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-2.1|0.562
91496279|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.92||0.708|TWO_SIDED|90.0|-1.9|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-1.9|0.708
91530771|NCT01370603|182937565|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.1|||||TWO_SIDED|97.5|-1.4|1.2|||ANCOVA|||||1.2|-1.4|
91702559|NCT00772005|183299732|SUPERIORITY_OR_OTHER|||||||0.7283||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7283
91702560|NCT00772005|183299733|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7610
91702561|NCT00772005|183299733|SUPERIORITY_OR_OTHER|||||||0.6091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6091
91530772|NCT01370603|182937566|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.3|||||TWO_SIDED|97.5|-1.8|1.2|||ANCOVA|||||1.2|-1.8|
91702562|NCT00772005|183299733|SUPERIORITY_OR_OTHER|||||||0.3368||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3368
91702563|NCT00772005|183299734|SUPERIORITY_OR_OTHER|||||||0.8457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8457
91702564|NCT00772005|183299734|SUPERIORITY_OR_OTHER|||||||0.4531||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4531
91702565|NCT00772005|183299734|SUPERIORITY_OR_OTHER|||||||0.6867||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6867
91702566|NCT00772005|183299735|SUPERIORITY_OR_OTHER|||||||0.9705||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9705
91702567|NCT00772005|183299735|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0021
91702568|NCT00772005|183299735|SUPERIORITY_OR_OTHER|||||||0.5013||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5013
91702569|NCT00772005|183299736|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7330
91702570|NCT00772005|183299736|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0068
91702571|NCT00772005|183299736|SUPERIORITY_OR_OTHER|||||||0.104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1040
91496280|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.852|TWO_SIDED|90.0|-1.9|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.9|0.852
91496281|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.14||0.347|TWO_SIDED|90.0|-3.0|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-3.0|0.347
91496282|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.14||0.759|TWO_SIDED|90.0|-2.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.2|0.759
91496283|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.28||0.574|TWO_SIDED|90.0|-2.9|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.9|0.574
91496284|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.09||0.831|TWO_SIDED|90.0|-2.1|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-2.1|0.831
91530773|NCT01370603|182937567|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-0.2|||||TWO_SIDED|97.5|-1.7|1.4|||ANCOVA|||||1.4|-1.7|
91530774|NCT01370603|182937568|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.5|||||TWO_SIDED|97.5|-1.9|1.0|||ANCOVA|||||1.0|-1.9|
91530775|NCT01370603|182937569|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|97.5|-4.9|4.9|||constrained Longitudinal Data Analysis|||||4.9|-4.9|
91496285|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.705|TWO_SIDED|90.0|-1.4|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.4|0.705
91496286|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.24||0.6|TWO_SIDED|90.0|-2.7|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.7|0.600
91530776|NCT01268059|182937571|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.205||||0.027|TWO_SIDED|95.0|1.1|4.5|||Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by histology, disease stage, and ECOG performance status.|Hazard ratio and its 95 percent (%) confidence interval ( CIs) were calculated using the Cox proportional hazard model stratified by histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|||4.5|1.1|0.027
91702572|NCT00772005|183299737|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8220
91702573|NCT00772005|183299737|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0144
91702574|NCT00772005|183299737|SUPERIORITY_OR_OTHER|||||||0.9464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9464
91702575|NCT03280225|183299797|OTHER||Odds Ratio (OR)|1.43||||0.302|TWO_SIDED|95.0|0.73|2.82|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a coordinator during the 6 month period following implementation compared to eligible Veterans being assigned a coordinator in the 6 month period prior to implementation.||2.82|0.73|.302
91702576|NCT03280225|183299798|OTHER||Odds Ratio (OR)|1.29||||0.226|TWO_SIDED|95.0|0.86|1.93|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a provider during the 6 month period following implementation compared to eligible Veterans being assigned a provider in the 6 month period prior to implementation.||1.93|0.86|0.226
91702577|NCT03280225|183299799|OTHER||Odds Ratio (OR)|1.23||||0.199|TWO_SIDED|95.0|0.9|1.7|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans receiving a care evaluation during the 6 month period following implementation compared to eligible Veterans receiving a care evaluation in the 6 month period prior to implementation.||1.70|0.90|0.199
91702578|NCT03280225|183299800|OTHER||Odds Ratio (OR)|1.38||||0.011|TWO_SIDED|95.0|1.08|1.76|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans where outreach was attempted during the 6 month period following implementation compared to eligible Veterans where outreach was attempted in the 6 month period prior to implementation.||1.76|1.08|0.011
91702579|NCT03280225|183299801|SUPERIORITY|||||||0.018|||||||ANOVA|F (4, 158) = 3.08||Program Needs||||.018
91702580|NCT03280225|183299801|SUPERIORITY|||||||0.136|||||||ANOVA|F (4, 158) = 1.78||Training Needs||||.136
91702581|NCT03280225|183299801|SUPERIORITY|Pressure for Change||||||0.812|||||||ANOVA|F (4, 158) = 0.39||||||.812
91702582|NCT03280225|183299801|SUPERIORITY|Staffing||||||0.358|||||||ANOVA|F (4, 158) = 1.10||||||.358
91702583|NCT03280225|183299801|SUPERIORITY|Mission||||||0.748|||||||ANOVA|F (4, 158) = 0.48||||||.748
91702584|NCT03280225|183299801|SUPERIORITY|||||||0.748|||||||ANOVA|F (4, 158) = 0.48||Cohesion||||.748
91702585|NCT03280225|183299801|SUPERIORITY|||||||0.005|||||||ANOVA|F (4, 158) = 3.88||Autonomy||||.005
91702586|NCT03280225|183299801|SUPERIORITY|||||||0.224|||||||ANOVA|F (4, 158) = 1.44||Communication||||.224
91702587|NCT03280225|183299801|SUPERIORITY|||||||0.043|||||||ANOVA|F (4, 158) = 2.52||Stress||||.043
91702588|NCT03280225|183299801|SUPERIORITY|||||||0.096|||||||ANOVA|F (4, 158) = 2.01||Change||||.096
91702589|NCT01273155|183299807|OTHER|Belinostat|Kendall's Tau|0.096||||0.327|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.327
91702590|NCT01273155|183299807|OTHER|Belinostat glucuronide|Kendall's Tau|-0.178||||0.063|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.063
91702591|NCT01273155|183299807|OTHER|Methyl belinostat|Kendall's Tau|0.382|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
91702592|NCT01273155|183299807|OTHER|M21|Kendall's Tau|0.253||||0.009|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.009
91496287|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.23||0.848|TWO_SIDED|90.0|-2.3|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-2.3|0.848
91496288|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.24||0.237|TWO_SIDED|90.0|-0.6|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-0.6|0.237
91496289|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.4||0.224|TWO_SIDED|90.0|-4.0|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-4.0|0.224
91496290|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.38||0.747|TWO_SIDED|90.0|-1.9|2.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.8|-1.9|0.747
91496291|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.37||0.764|TWO_SIDED|90.0|-2.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-2.8|0.764
91496292|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.22||0.487|TWO_SIDED|90.0|-1.3|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.0|-1.3|0.487
91496293|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.53||0.744|TWO_SIDED|90.0|-2.1|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-2.1|0.744
91530777|NCT01268059|182937573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.487
91496294|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.34|TWO_SIDED|90.0|-1.1|4.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.1|-1.1|0.340
91496295|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.36||0.477|TWO_SIDED|90.0|-3.3|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-3.3|0.477
91496296|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.51||0.482|TWO_SIDED|90.0|-1.5|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.7|-1.5|0.482
91496297|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.49||0.719|TWO_SIDED|90.0|-3.1|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-3.1|0.719
91496298|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.36||0.245|TWO_SIDED|90.0|-0.7|4.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.0|-0.7|0.245
91496299|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.93||0.586|TWO_SIDED|90.0|-2.3|4.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.4|-2.3|0.586
91702593|NCT01273155|183299807|OTHER|M24|Kendall's Tau|-0.278||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
91702594|NCT01273155|183299807|OTHER|M26|Kendall's Tau|0.098||||0.312|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.312
91702595|NCT01273155|183299808|OTHER|Belinostat|Kendall's Tau|0.215||||0.025|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.025
91702596|NCT01273155|183299808|OTHER|Methyl belinostat|Kendall's Tau|0.426|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
91702597|NCT01273155|183299808|OTHER|M21|Kendall's Tau|0.337|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
91702598|NCT01273155|183299808|OTHER|M24|Kendall's Tau|-0.061||||0.524|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.524
91702599|NCT01273155|183299808|OTHER|M26|Kendall's Tau|0.246||||0.01|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.010
91702600|NCT01273155|183299809|OTHER||Kendall's Tau|0.057||||0.548|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.548
91702601|NCT01273155|183299810|OTHER|Belinostat|Kendall's Tau|0.091||||0.34|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.340
91702602|NCT01273155|183299810|OTHER|Belinostat glucuronide|Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
91702603|NCT01273155|183299810|OTHER|Methyl belinostat|Kendall's Tau|0.268||||0.005|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.005
91496300|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.44|TWO_SIDED|90.0|-4.8|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-4.8|0.440
91496301|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.75||0.159|TWO_SIDED|90.0|-0.5|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||5.6|-0.5|0.159
91530778|NCT01268059|182937573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and ECOG performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.386
91736248|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39||||0.015|TWO_SIDED|95.0|1.46|13.32||p-value is for Endpoint Daily Mean 7-Point Blood Glucose.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.32|1.46|0.015
91736249|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.12||||0.021|TWO_SIDED|95.0|1.1|13.14||p-value is for Endpoint Daily Mean Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.14|1.10|0.021
91736250|NCT00560417|183365532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.97|||<|0.001|TWO_SIDED|95.0|5.01|18.93||p-value is for Endpoint Daily Mean Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.93|5.01|<0.001
91736251|NCT00560417|183365533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.131|TWO_SIDED|95.0|-0.68|5.22||p-value is for Baseline.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||5.22|-0.68|0.131
91702604|NCT01273155|183299810|OTHER|M21|Kendall's Tau|0.242||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
91702605|NCT01273155|183299810|OTHER|M24|Kendall's Tau|-0.114||||0.231|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.231
91702606|NCT01273155|183299810|OTHER|M26|Kendall's Tau|0.22||||0.021|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.021
91702607|NCT01273155|183299811|OTHER||Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
91702608|NCT01273155|183299812|OTHER||Kendall's Tau|0.06||||0.531|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.531
91702609|NCT01273155|183299813|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.224||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
91702610|NCT01273155|183299813|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.295||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
91530779|NCT01268059|182937576|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.017|||||TWO_SIDED|95.0|1.2|7.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||7.4|1.2|
91736252|NCT00560417|183365533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.001|TWO_SIDED|95.0|2.82|9.16||p-value is for Endpoint.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||9.16|2.82|<0.001
91736253|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||p-value is for all reported hypoglycemic events at endpoint.|Fisher Exact|||||||0.826
91736254|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||p-value is for all reported hypoglycemic events overall.|Fisher Exact|||||||0.394
91736255|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||p-value is for non-nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.070
91736256|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for non-nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.133
91496302|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.15||0.72|TWO_SIDED|90.0|-1.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.6|0.720
91496303|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.13||0.991|TWO_SIDED|90.0|-2.0|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.9|-2.0|0.991
91496304|NCT02310568|182864238|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.704|TWO_SIDED|90.0|-1.5|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.5|0.704
91496305|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82||0.539|TWO_SIDED|90.0|-0.9|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.9|0.539
91496306|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.78||0.439|TWO_SIDED|90.0|-0.7|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.7|0.439
91702611|NCT01273155|183299813|OTHER|M21/belinostat|Kendall's Tau|0.335||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
91702612|NCT01273155|183299813|OTHER|M24/belinostat|Kendall's Tau|-0.24||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
91702613|NCT01273155|183299813|OTHER|M26/belinostat|Kendall's Tau|0.127||||0.275|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.275
91702614|NCT01273155|183299813|OTHER|M24/M26|Kendall's Tau|-0.308||||0.002|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.002
91702615|NCT01273155|183299813|OTHER|M26/M21|Kendall's Tau|-0.159||||0.095|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.095
91702616|NCT01273155|183299814|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.055||||0.568|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.568
91702617|NCT01273155|183299814|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.38|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
91702618|NCT01273155|183299814|OTHER|M21/belinostat|Kendall's Tau|0.315||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
91702619|NCT01273155|183299814|OTHER|M24/belinostat|Kendall's Tau|-0.205||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
91702620|NCT01273155|183299814|OTHER|M26/belinostat|Kendall's Tau|0.218||||0.033|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.033
91702621|NCT01273155|183299814|OTHER|M24/M26|Kendall's Tau|-0.309||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
91702622|NCT01273155|183299814|OTHER|M26/M21|Kendall's Tau|-0.205||||0.032|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.032
91702623|NCT01256385|183299817|SUPERIORITY_OR_OTHER|||||||0.73|||||||Log Rank|||||||0.73
91702624|NCT01256385|183299818|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
91702625|NCT01256385|183299819|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
91702626|NCT01256385|183299820|SUPERIORITY|||||||0.006|||||||Chi-squared|||PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.006
91705616|NCT01026818|183305791|SUPERIORITY_OR_OTHER||LS Mean Differences|1.62|STANDARD_ERROR_OF_MEAN|1.22||0.184|TWO_SIDED|95.0|-0.78|4.03||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.03|-0.78|0.184
91702627|NCT01256385|183299820|SUPERIORITY|||||||0.037||||||1-sided.|Chi-squared|||PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.037
91702628|NCT01256385|183299821|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
91702629|NCT02584959|183299874|OTHER||Difference in LS means|-2.32|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.744|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.744|-2.895|<0.0001
91702630|NCT02584959|183299876|OTHER||Difference in LS means|-2.323|||<|0.0001|TWO_SIDED|95.0|-2.969|-1.677|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.677|-2.969|<0.0001
91702631|NCT02584959|183299879|OTHER||Difference in LS means|-4.881|||<|0.0001|TWO_SIDED|95.0|-6.113|-3.649|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-3.649|-6.113|<0.0001
91702632|NCT02584959|183299880|OTHER||Difference in LS means|5.435|||<|0.0001|TWO_SIDED|95.0|3.981|6.889|||Mixed Models Analysis|||||6.889|3.981|<0.0001
91702633|NCT02584959|183299881|OTHER||Difference in LS means|-2.175|||<|0.0001|TWO_SIDED|95.0|-2.75|-1.599|||Mixed Models Analysis|||||-1.599|-2.750|<0.0001
91702634|NCT02584959|183299896|OTHER||Difference in LS means|-31.735||||0.0001|TWO_SIDED|95.0|-42.696|-20.773|||Mixed Models Analysis|||The Least Square means, 95% confidence intervals and p-values are based on mixed effect linear model with period, sequence, use of prophylactic therapy with C1 INH at randomization and treatment as fixed effects and subject nested within sequence as a random effect.||-20.773|-42.696|0.0001
91496307|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92||0.914|TWO_SIDED|90.0|-1.6|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-1.6|0.914
91496308|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.86||0.892|TWO_SIDED|90.0|-1.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.3|0.892
91496309|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.463|TWO_SIDED|90.0|-0.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-0.8|0.463
91496310|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.611|TWO_SIDED|90.0|-2.1|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-2.1|0.611
91702635|NCT04908475|183299901|SUPERIORITY||Adjusted Difference|50.7|||<|0.001|TWO_SIDED|95.0|41.3|60.1||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||60.1|41.3|< 0.001
91702636|NCT04908475|183299902|SUPERIORITY||Adjusted Difference|56.8|||<|0.001|TWO_SIDED|95.0|47.7|66.0||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||66.0|47.7|< 0.001
91702637|NCT04908475|183299903|SUPERIORITY||Difference|69.7|||<|0.001|TWO_SIDED|95.0|59.5|80.0|||Chi-squared|||||80.0|59.5|< 0.001
91702638|NCT04908475|183299904|SUPERIORITY||Adjusted Difference|65.9|||<|0.001|TWO_SIDED|95.0|57.6|73.9||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\] for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||73.9|57.6|< 0.001
91702639|NCT04908475|183299905|SUPERIORITY||Difference|71.6|||<|0.001|TWO_SIDED|95.0|60.9|82.3|||Chi-squared|||||82.3|60.9|< 0.001
91702640|NCT04908475|183299906|SUPERIORITY||Difference|69.4|||<|0.001|TWO_SIDED|95.0|58.6|80.2|||Chi-squared|||||80.2|58.6|< 0.001
91702641|NCT01267201|183299911|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.11|||||TWO_SIDED|90.0|88.23|96.15||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||96.15|88.23|
91736257|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.013
91736258|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||p-value is for nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.061
91736259|NCT00560417|183365534|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||p-value is for severe hypoglycemic events overall.|Fisher Exact|||||||0.248
91736260|NCT00560417|183365535|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||p-value is for All reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.628
91736261|NCT00560417|183365535|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||p-value is for All reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.570
91496311|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.88||0.321|TWO_SIDED|90.0|-0.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.4|-0.6|0.321
91496312|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.85||0.294|TWO_SIDED|90.0|-0.5|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-0.5|0.294
91496313|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.99||0.987|TWO_SIDED|90.0|-1.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-1.7|0.987
91496314|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.04||0.599|TWO_SIDED|90.0|-1.2|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.2|0.599
91496315|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.322|TWO_SIDED|90.0|-0.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.6|-0.7|0.322
91496316|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.17||0.704|TWO_SIDED|90.0|-2.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.4|0.704
91496317|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.38||0.804|TWO_SIDED|90.0|-2.0|2.7|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-2.0|0.804
91705617|NCT01026818|183305791|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-1.54|3.16||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.16|-1.54|0.500
91496318|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.38||0.559|TWO_SIDED|90.0|-3.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-3.2|0.559
91496319|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.27||0.369|TWO_SIDED|90.0|-1.0|3.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.4|-1.0|0.369
91496320|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.56||0.313|TWO_SIDED|90.0|-1.1|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-1.1|0.313
91496321|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.56||0.56|TWO_SIDED|90.0|-1.8|3.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.6|-1.8|0.560
91496322|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.43||0.635|TWO_SIDED|90.0|-1.8|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-1.8|0.635
91496323|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.62||0.538|TWO_SIDED|90.0|-1.8|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.8|-1.8|0.538
91496324|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.942|TWO_SIDED|90.0|-2.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.9|-2.7|0.942
91496325|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.555|TWO_SIDED|90.0|-1.7|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-1.7|0.555
91496326|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.96||0.728|TWO_SIDED|90.0|-4.1|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-4.1|0.728
91496327|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.95||0.362|TWO_SIDED|90.0|-5.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-5.2|0.362
91496328|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.81||0.538|TWO_SIDED|90.0|-2.0|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-2.0|0.538
91496329|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.949|TWO_SIDED|90.0|-2.0|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.8|-2.0|0.949
91496330|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.09||0.708|TWO_SIDED|90.0|-2.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.5|-2.3|0.708
91496331|NCT02310568|182864239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07||0.752|TWO_SIDED|90.0|-1.5|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.2|-1.5|0.752
91702642|NCT01267201|183299911|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.22|||||TWO_SIDED|90.0|86.49|94.11||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||94.11|86.49|
91496332|NCT02310568|182864240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|90.0|0.37|2.45|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||2.45|0.37|
91496333|NCT02310568|182864240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|90.0|0.39|6.88|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||6.88|0.39|
91496334|NCT02310568|182864240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.23|1.49|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||1.49|0.23|
91702643|NCT01267201|183299912|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.76|||||TWO_SIDED|90.0|88.06|101.98||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.98|88.06|
91702644|NCT01267201|183299912|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|83.89|||||TWO_SIDED|90.0|78.06|90.17||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||90.17|78.06|
91702645|NCT00483704|183299915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.8|3.58|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.58|1.80|<0.001
91702646|NCT00483704|183299915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.15|4.27|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.27|2.15|<0.001
91702647|NCT00483704|183299916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.35|3.9|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.90|2.35|<0.001
91702648|NCT00483704|183299916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|2.17|3.61|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|2.17|<0.001
91702649|NCT00483704|183299917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.001|TWO_SIDED|95.0|2.05|7.23|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||7.23|2.05|<0.001
91702650|NCT00483704|183299917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.001|TWO_SIDED|95.0|3.36|11.39|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||11.39|3.36|<0.001
91496335|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.158||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.||||0.158
91702651|NCT00483704|183299918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.96|3.51|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.51|1.96|<0.001
91702652|NCT00483704|183299918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.001|TWO_SIDED|95.0|2.41|4.34|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.34|2.41|<0.001
91702653|NCT00483704|183299919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.3|2.11|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.11|1.30|<0.001
91702654|NCT00483704|183299919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.14|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.14|1.31|<0.001
91702655|NCT00483704|183299920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.22|1.36|<0.001
91702656|NCT00483704|183299920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.06|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.06|1.26|<0.001
91702657|NCT00483704|183299921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.17|1.28|<0.001
91702658|NCT00483704|183299921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.21|2.04|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.04|1.21|<0.001
91702659|NCT00483704|183299924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.78|4.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.07|1.78|<0.001
91702660|NCT00483704|183299924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.3|5.19|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.19|2.30|<0.001
91736262|NCT00560417|183365535|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||p-value is for Non-Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.116
91496336|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.025||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.||||0.025
91496337|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.007||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.||||0.007
91496338|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.061||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.||||0.061
91702661|NCT00483704|183299925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.56|3.69|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.69|1.56|<0.001
91702662|NCT00483704|183299925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.22|5.12|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.12|2.22|<0.001
91702663|NCT00483704|183299926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.65|3.38|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.38|1.65|<0.001
91702664|NCT00483704|183299926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|1.97|4.01|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.01|1.97|<0.001
91736263|NCT00560417|183365535|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for Non-Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.044
91496339|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.107||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.||||0.107
91496340|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.237||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.||||0.237
91496341|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.497||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.||||0.497
91496342|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.704||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.||||0.704
91702665|NCT00483704|183299927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32|||<|0.001|TWO_SIDED|95.0|1.52|3.54|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.54|1.52|<0.001
91702666|NCT00483704|183299927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02|||<|0.001|TWO_SIDED|95.0|2.0|4.56|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.56|2.00|<0.001
91702667|NCT02537431|183299941|OTHER||Mean|-54.18|||<|0.0001|TWO_SIDED|95.0|-68.64|-39.72||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-39.72|-68.64|< 0.0001
91496343|NCT02989194|182864246|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.585||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.||||0.585
91496344|NCT02989194|182864257|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.083|||||||t-test, 2 sided|||A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.||||0.083
91702668|NCT02537431|183299942|OTHER||||||<|0.0001||||||The p-value is for testing the proportion of participants achieving the mean serum phosphorus levels above the LLN (2.5 mg/dL \[0.81 mmol/L\]) against 0% from the binomial test.|binomial test|||||||<0.0001
91702669|NCT02537431|183299943|OTHER||Mean|-32.21|||<|0.0001|TWO_SIDED|95.0|-40.25|-24.17||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-24.17|-40.25|<0.0001
91702670|NCT02537431|183299944|OTHER||Mean|-26.0||||0.0002|TWO_SIDED|95.0|-36.08|-15.91||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-15.91|-36.08|0.0002
91702671|NCT02537431|183299945|OTHER||Mean|-52.24||||0.0199|TWO_SIDED|95.0|-94.08|-10.41||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-10.41|-94.08|0.0199
91702672|NCT02537431|183299957|OTHER||Least Squares Mean (GEE)|107.75|||||TWO_SIDED|95.0|76.46|139.03|||||From the generalized estimation equation (GEE) model which includes change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 1||139.03|76.46|
91702673|NCT02537431|183299957|OTHER||LS Mean|48.41|||||TWO_SIDED|95.0|33.91|62.91|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 2||62.91|33.91|
91702674|NCT02537431|183299957|OTHER||LS Mean|13.58|||||TWO_SIDED|95.0|6.85|20.31|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 4||20.31|6.85|
91702675|NCT02537431|183299957|OTHER||LS Mean|-1.34|||||TWO_SIDED|95.0|-8.43|5.75|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 20||5.75|-8.43|
91702676|NCT02537431|183299957|OTHER||LS Mean|31.75|||||TWO_SIDED|95.0|21.49|42.0|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 21||42.00|21.49|
91702677|NCT02537431|183299957|OTHER||LS Mean|11.5|||||TWO_SIDED|95.0|3.54|19.46|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 22||19.46|3.54|
91702678|NCT02537431|183299957|OTHER||LS Mean|-3.04|||||TWO_SIDED|95.0|-12.62|6.55|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 24||6.55|-12.62|
91702679|NCT02537431|183299957|OTHER||LS Mean|-1.72||||0.6821|TWO_SIDED|95.0|-9.93|6.5|||GEE model||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 48||6.50|-9.93|0.6821
91702680|NCT02537431|183299957|OTHER||LS mean|-5.73|||||TWO_SIDED|95.0|-12.38|0.92|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 60||0.92|-12.38|
91702681|NCT02537431|183299957|OTHER||LS mean|3.36|||||TWO_SIDED|95.0|-4.45|11.18|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 70||11.18|-4.45|
91702682|NCT02537431|183299957|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.22|0.13|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 72||0.13|-11.22|
91702683|NCT02537431|183299957|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.35|0.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 84||0.26|-11.35|
91702684|NCT02537431|183299957|OTHER||LS mean|9.63|||||TWO_SIDED|95.0|1.33|17.94|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 94||17.94|1.33|
91496345|NCT02989194|182864258|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.169||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|t-test, 2 sided|||The null hypothesis was defined as no treatment difference.||||0.169
91702685|NCT02537431|183299957|OTHER||LS mean|-6.09|||||TWO_SIDED|95.0|-10.8|-1.38||||||Week 96||-1.38|-10.80|
91702686|NCT02537431|183299957|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-9.22|9.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 108||9.26|-9.22|
91702687|NCT02537431|183299957|OTHER||LS mean|1.45|||||TWO_SIDED|95.0|-6.77|9.68|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 120||9.68|-6.77|
91702688|NCT02537431|183299957|OTHER||LS mean|-1.69|||||TWO_SIDED|95.0|-5.6|2.21|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 132||2.21|-5.60|
91496346|NCT02989194|182864259|SUPERIORITY|Descriptive Statistics. Statistical comparisons were performed using log rank test.||||||0.028||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|||Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|||0.028
91702689|NCT02537431|183299958|OTHER||LS Mean|0.1|||||TWO_SIDED|95.0|-0.15|0.35|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 12||0.35|-0.15|
91702690|NCT02537431|183299958|OTHER||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.19|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 24||0.11|-0.19|
91702691|NCT02537431|183299958|OTHER||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 36||0.11|-0.12|
91702692|NCT02537431|183299958|OTHER||LS Mean|-0.04||||0.6021|TWO_SIDED|95.0|-0.19|0.11|||GEE model||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 48||0.11|-0.19|0.6021
91702693|NCT02537431|183299958|OTHER||LS mean|0.0|||||TWO_SIDED|95.0|-0.19|0.19|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 72||0.19|-0.19|
91702694|NCT02537431|183299958|OTHER||LS mean|-0.13|||||TWO_SIDED|95.0|-0.29|0.03|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 96||0.03|-0.29|
91702695|NCT02537431|183299958|OTHER||LS mean|-0.07|||||TWO_SIDED|95.0|-0.41|0.26|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|EOS II||0.26|-0.41|
91702696|NCT02537431|183299959|OTHER||LS Mean|1.76|||||TWO_SIDED|95.0|1.49|2.03|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 2||2.03|1.49|
91530780|NCT01268059|182937576|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.134|||||TWO_SIDED|95.0|0.3|4.3|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||4.3|0.3|
91702697|NCT02537431|183299959|OTHER||LS Mean|0.78|||||TWO_SIDED|95.0|0.59|0.97|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 4||0.97|0.59|
91702698|NCT02537431|183299959|OTHER||LS Mean|0.58|||||TWO_SIDED|95.0|0.34|0.82|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 12||0.82|0.34|
91702699|NCT02537431|183299959|OTHER||LS Mean|0.87|||||TWO_SIDED|95.0|0.74|0.99|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 22||0.99|0.74|
91702700|NCT02537431|183299959|OTHER||LS Mean|0.44|||||TWO_SIDED|95.0|0.24|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 24||0.64|0.24|
91496347|NCT02989194|182864261|EQUIVALENCE|Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.||||||0.173||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.||All null hypotheses were defined as no treatment difference.||||0.173
91496348|NCT00711711|182864262|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.51
91496349|NCT00711711|182864263|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.58
91496350|NCT00616200|182864272|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Sickness Impact Profile scores improved.||||.001
91496351|NCT02057406|182864303|SUPERIORITY|The EPA/DHA arm versus placebo at Week 12.||||||0.74|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.74
91496352|NCT02057406|182864303|SUPERIORITY|High EPA group versus placebo group at Week 12.||||||0.45|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.45
91496353|NCT02057406|182864304|SUPERIORITY|Active supplements (2:1 EPA/DHA and High EPA combined) versus placebo at Week 12.|||||<|0.0001|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||<0.0001
91496354|NCT02057406|182864304|SUPERIORITY|2:1 EPA/DHA versus High EPA at Week 12.||||||0.12|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||0.12
91496355|NCT04492618|182864307|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91496356|NCT01635101|182864323|OTHER||LS Mean Difference|-11.8||||0.736|TWO_SIDED|97.5|-91.0|67.3|||ANOVA|||Difference in Least Squares (LS) Means||67.3|-91.0|0.736
91496357|NCT01635101|182864323|OTHER||LS Mean Difference|1.4||||0.967|TWO_SIDED|97.5|-75.9|78.7|||ANOVA|||LS Mean Difference||78.7|-75.9|0.967
91496358|NCT01327885|182864333|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||=|0.0169|TWO_SIDED|95.0|0.618|0.954||The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.||0.954|0.618|=0.0169
91496359|NCT01327885|182864334|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.877|||=|0.2287|TWO_SIDED|95.0|0.71|1.085||P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.085|0.710|=0.2287
91496360|NCT01327885|182864335|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3||||0.253|TWO_SIDED|95.0|0.8|1.9||The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.9|0.8|0.253
91496361|NCT01327885|182864336|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9|||=|0.741|TWO_SIDED|95.0|0.7|1.4||The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.4|0.7|=0.741
91496362|NCT03975790|182864339|SUPERIORITY|||||||0.4695|||||||Chi-squared|||||||0.4695
91496363|NCT03975790|182864339|SUPERIORITY|||||||0.7644|||||||Chi-squared|||||||0.7644
91496364|NCT03975790|182864339|SUPERIORITY|||||||0.8316|||||||Chi-squared|||||||0.8316
91496365|NCT03975790|182864340|SUPERIORITY|||||||0.9829|||||||Chi-squared|||||||0.9829
91496366|NCT03975790|182864340|SUPERIORITY|||||||0.8021|||||||Chi-squared|||||||0.8021
91496367|NCT03975790|182864340|SUPERIORITY|||||||0.8376|||||||Chi-squared|||||||0.8376
91496368|NCT03975790|182864341|SUPERIORITY|||||||0.2864|||||||t-test|||||||0.2864
91496369|NCT03975790|182864341|SUPERIORITY|||||||0.1583|||||||t-test|||||||0.1583
91496370|NCT03975790|182864341|SUPERIORITY|||||||0.4546|||||||t-test|||||||0.4546
91702701|NCT02537431|183299959|OTHER||LS Mean|0.2||||0.043|TWO_SIDED|95.0|0.01|0.38|||GEE model||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 48||0.38|0.01|0.0430
91702702|NCT02537431|183299959|OTHER||LS mean|0.3|||||TWO_SIDED|95.0|-0.04|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 60||0.64|-0.04|
91702703|NCT02537431|183299959|OTHER||LS mean|0.28|||||TWO_SIDED|95.0|0.03|0.52|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 72||0.52|0.03|
91702704|NCT02537431|183299959|OTHER||LS mean|0.39|||||TWO_SIDED|95.0|0.13|0.66|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 84||0.66|0.13|
91702705|NCT02537431|183299959|OTHER||LS mean|0.29|||||TWO_SIDED|95.0|0.1|0.48|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 96||0.48|0.10|
91496371|NCT03975790|182864342|SUPERIORITY|||||||0.028|||||||t-test|||||||0.0280
91496372|NCT03975790|182864342|SUPERIORITY|||||||0.0106|||||||t-test|||||||0.0106
91496373|NCT03975790|182864342|SUPERIORITY|||||||0.7293|||||||t-test|||||||0.7293
91496374|NCT03975790|182864343|SUPERIORITY|||||||0.9215|||||||Chi-squared|||||||0.9215
91496375|NCT03975790|182864343|SUPERIORITY|||||||0.6078|||||||Chi-squared|||||||0.6078
91496376|NCT03975790|182864343|SUPERIORITY|||||||0.6258|||||||Chi-squared|||||||0.6258
91496377|NCT03975790|182864344|SUPERIORITY|||||||0.3586|||||||Chi-squared|||||||0.3586
91496378|NCT03975790|182864344|SUPERIORITY|||||||0.5117|||||||Chi-squared|||||||0.5117
91496379|NCT03975790|182864345|SUPERIORITY|||||||0.5372|||||||t-test|||||||0.5372
91496380|NCT03975790|182864345|SUPERIORITY|||||||0.6155|||||||t-test|||||||0.6155
91496381|NCT03975790|182864345|SUPERIORITY|||||||0.9696|||||||t-test|||||||0.9696
91496382|NCT03975790|182864346|SUPERIORITY|||||||0.2514|||||||t-test|||||||0.2514
91496383|NCT03975790|182864346|SUPERIORITY|||||||0.9851|||||||t-test|||||||0.9851
91496384|NCT03975790|182864346|SUPERIORITY|||||||0.4309|||||||t-test|||||||0.4309
91496385|NCT03975790|182864347|SUPERIORITY|||||||0.6033|||||||t-test|||||||0.6033
91496386|NCT03975790|182864347|SUPERIORITY|||||||0.348|||||||t-test|||||||0.3480
91496387|NCT03975790|182864347|SUPERIORITY|||||||0.5375|||||||t-test|||||||0.5375
91496388|NCT03975790|182864348|SUPERIORITY|||||||0.0345|||||||Chi-squared|||Other aftercare||||0.0345
91496389|NCT03975790|182864348|SUPERIORITY|||||||0.2316|||||||Chi-squared|||Other aftercare||||0.2316
91496390|NCT03975790|182864348|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other aftercare||||0.7349
91496391|NCT03975790|182864348|SUPERIORITY|||||||0.0774|||||||Chi-squared|||Other connective tissue disease||||0.0774
91496392|NCT03975790|182864348|SUPERIORITY|||||||0.4228|||||||Chi-squared|||Other connective tissue disease||||0.4228
91496393|NCT03975790|182864348|SUPERIORITY|||||||0.0583|||||||Chi-squared|||Other connective tissue disease||||0.0583
91496394|NCT03975790|182864348|SUPERIORITY|||||||0.9683|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9683
91496395|NCT03975790|182864348|SUPERIORITY|||||||0.8877|||||||Chi-squared|||Other non-traumatic joint disorders||||0.8877
91496396|NCT03975790|182864348|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9228
91496397|NCT03975790|182864348|SUPERIORITY|||||||0.7661|||||||Chi-squared|||Medical examination/evaluation||||0.7661
91496398|NCT03975790|182864348|SUPERIORITY|||||||0.3034|||||||Chi-squared|||Medical examination/evaluation||||0.3034
91496399|NCT03975790|182864348|SUPERIORITY|||||||0.2765|||||||Chi-squared|||Medical examination/evaluation||||0.2765
91496400|NCT03975790|182864348|SUPERIORITY|||||||0.8652|||||||Chi-squared|||Other suspected conditions||||0.8652
91496401|NCT03975790|182864348|SUPERIORITY|||||||0.2243|||||||Chi-squared|||Other suspected conditions||||0.2243
91496402|NCT03975790|182864348|SUPERIORITY|||||||0.3449|||||||Chi-squared|||Other suspected conditions||||0.3449
91496403|NCT03975790|182864348|SUPERIORITY|||||||0.3529|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.3529
91496404|NCT03975790|182864348|SUPERIORITY|||||||0.1012|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1012
91496405|NCT03975790|182864348|SUPERIORITY|||||||0.4123|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4123
91496406|NCT03975790|182864348|SUPERIORITY|||||||0.2742|||||||Chi-squared|||Osteoarthritis||||0.2742
91496407|NCT03975790|182864348|SUPERIORITY|||||||0.1009|||||||Chi-squared|||Osteoarthritis||||0.1009
91496408|NCT03975790|182864348|SUPERIORITY|||||||0.0318|||||||Chi-squared|||Osteoarthritis||||0.0318
91496409|NCT03975790|182864348|SUPERIORITY|||||||0.4808|||||||Chi-squared|||Essential hypertension||||0.4808
91496410|NCT03975790|182864348|SUPERIORITY|||||||0.0778|||||||Chi-squared|||Essential hypertension||||0.0778
91496411|NCT03975790|182864348|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Essential hypertension||||0.2871
91496412|NCT03975790|182864348|SUPERIORITY|||||||0.7356|||||||Chi-squared|||Residual codes; unclassified||||0.7356
91496413|NCT03975790|182864348|SUPERIORITY|||||||0.4975|||||||Chi-squared|||Residual codes; unclassified||||0.4975
91496414|NCT03975790|182864348|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
91496415|NCT03975790|182864348|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Disorders of lipid metabolism||||0.3559
91496416|NCT03975790|182864348|SUPERIORITY|||||||0.7725|||||||Chi-squared|||Disorders of lipid metabolism||||0.7725
91702706|NCT02537431|183299959|OTHER||LS mean|0.21|||||TWO_SIDED|95.0|0.08|0.34|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|EOSII||0.34|0.08|
91530781|NCT01268059|182937577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.315|||||TWO_SIDED|95.0|0.7|2.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||2.4|0.7|
91530782|NCT01268059|182937577|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.083|||||TWO_SIDED|95.0|0.4|10.8|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||10.8|0.4|
91530783|NCT03660943|182937590|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|1.192||0.0833|TWO_SIDED|95.0|-4.42|0.27|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.27|-4.42|0.0833
91530784|NCT03660943|182937591|SUPERIORITY|The number of NPRS subjects differed from the WOMAC outcomes because of differences in missing data.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.251||0.0935|TWO_SIDED|95.0|-0.91|0.07|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.07|-0.91|0.0935
91496417|NCT03975790|182864348|SUPERIORITY|||||||0.3875|||||||Chi-squared|||Disorders of lipid metabolism||||0.3875
91496418|NCT03975790|182864348|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Back problems||||0.0225
91496419|NCT03975790|182864348|SUPERIORITY|||||||0.4427|||||||Chi-squared|||Back problems||||0.4427
91496420|NCT03975790|182864348|SUPERIORITY|||||||0.4094|||||||Chi-squared|||Back problems||||0.4094
91496421|NCT03975790|182864348|SUPERIORITY|||||||0.8775|||||||Chi-squared|||Other upper respiratory infections||||0.8775
91702707|NCT02537431|183299960|OTHER||LS Mean|0.07|||||TWO_SIDED|95.0|0.06|0.08|||||From the GEE model, which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 2||0.08|0.06|
91702708|NCT02537431|183299960|OTHER||LS Mean|0.03|||||TWO_SIDED|95.0|0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 4||0.06|0.01|
91702709|NCT02537431|183299960|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 12||0.04|-0.01|
91702710|NCT02537431|183299960|OTHER||LS Mean|0.04|||||TWO_SIDED|95.0|0.02|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 22||0.05|0.02|
91702711|NCT02537431|183299960|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Week 24||0.04|-0.02|
91702712|NCT02537431|183299960|OTHER||LS Mean|0.0||||0.8377|TWO_SIDED|95.0|-0.05|0.04|||GEE model||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 48||0.04|-0.05|0.8377
91702713|NCT02537431|183299960|OTHER||LS mean|0.03|||||TWO_SIDED|95.0|0.0|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 60||0.06|-0.00|
91702714|NCT02537431|183299960|OTHER||LS mean|-0.02|||||TWO_SIDED|95.0|-0.09|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 72||0.05|-0.09|
91496422|NCT03975790|182864348|SUPERIORITY|||||||0.3525|||||||Chi-squared|||Other upper respiratory infections||||0.3525
91496423|NCT03975790|182864348|SUPERIORITY|||||||0.4724|||||||Chi-squared|||Other upper respiratory infections||||0.4724
91496424|NCT03975790|182864348|SUPERIORITY|||||||0.717|||||||Chi-squared|||Other lower respiratory disease||||0.7170
91496425|NCT03975790|182864348|SUPERIORITY|||||||0.2909|||||||Chi-squared|||Other lower respiratory disease||||0.2909
91496426|NCT03975790|182864348|SUPERIORITY|||||||0.5057|||||||Chi-squared|||Other lower respiratory disease||||0.5057
91496427|NCT03975790|182864348|SUPERIORITY|||||||0.2613|||||||Chi-squared|||Other nervous system disorders||||0.2613
91496428|NCT03975790|182864348|SUPERIORITY|||||||0.9901|||||||Chi-squared|||Other nervous system disorders||||0.9901
91496429|NCT03975790|182864348|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Other nervous system disorders||||0.4768
91496430|NCT03975790|182864348|SUPERIORITY|||||||0.0219|||||||Chi-squared|||Other skin disorders||||0.0219
91496431|NCT03975790|182864348|SUPERIORITY|||||||0.5172|||||||Chi-squared|||Other skin disorders||||0.5172
91496432|NCT03975790|182864348|SUPERIORITY|||||||0.0278|||||||Chi-squared|||Other skin disorders||||0.0278
91496433|NCT03975790|182864348|SUPERIORITY|||||||0.6103|||||||Chi-squared|||Thyroid disorders||||0.6103
91496434|NCT03975790|182864348|SUPERIORITY|||||||0.1682|||||||Chi-squared|||Thyroid disorders||||0.1682
91496435|NCT03975790|182864348|SUPERIORITY|||||||0.3654|||||||Chi-squared|||Thyroid disorders||||0.3654
91496436|NCT03975790|182864348|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7637
91496437|NCT03975790|182864348|SUPERIORITY|||||||0.8693|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.8693
91702715|NCT02537431|183299960|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 84||0.06|-0.01|
91702716|NCT02537431|183299960|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 96||0.05|-0.01|
91702717|NCT02537431|183299960|OTHER||LS mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|EOSII||0.03|-0.01|
91702718|NCT02537431|183299961|OTHER||LS Mean|99.18|||||TWO_SIDED|95.0|76.83|121.53|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||121.53|76.83|
91702719|NCT02537431|183299961|OTHER||LS Mean|104.33|||||TWO_SIDED|95.0|82.47|126.19|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||126.19|82.47|
91496438|NCT03975790|182864348|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7349
91496439|NCT03975790|182864348|SUPERIORITY|||||||0.7324|||||||Chi-squared|||Malaise/fatigue||||0.7324
91702720|NCT02537431|183299961|OTHER||LS Mean|52.49|||<|0.0001|TWO_SIDED|95.0|29.84|75.13|||GEE model||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||75.13|29.84|< 0.0001
91702721|NCT02537431|183299961|OTHER||LS mean|37.29|||||TWO_SIDED|95.0|13.19|61.38|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||61.38|13.19|
91702722|NCT02537431|183299961|OTHER||LS mean|29.29|||||TWO_SIDED|95.0|3.18|55.4|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||55.40|3.18|
91702723|NCT02537431|183299961|OTHER||LS mean|2.14|||||TWO_SIDED|95.0|-17.67|21.94|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||21.94|-17.67|
91702724|NCT02537431|183299962|OTHER||LS Mean|133.08|||||TWO_SIDED|95.0|106.26|159.89|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||159.89|106.26|
91702725|NCT02537431|183299962|OTHER||LS Mean|137.8|||||TWO_SIDED|95.0|106.95|168.65|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||168.65|106.95|
91496440|NCT03975790|182864348|SUPERIORITY|||||||0.4182|||||||Chi-squared|||Malaise/fatigue||||0.4182
91496441|NCT03975790|182864348|SUPERIORITY|||||||0.62|||||||Chi-squared|||Malaise/fatigue||||0.6200
91496442|NCT03975790|182864348|SUPERIORITY|||||||0.6064|||||||Chi-squared|||Esophageal disorders||||0.6064
91496443|NCT03975790|182864348|SUPERIORITY|||||||0.636|||||||Chi-squared|||Esophageal disorders||||0.6360
91702726|NCT02537431|183299962|OTHER||LS Mean|76.86|||<|0.0001|TWO_SIDED|95.0|49.2|104.53|||GEE model||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||104.53|49.20|< 0.0001
91496444|NCT03975790|182864348|SUPERIORITY|||||||0.9445|||||||Chi-squared|||Esophageal disorders||||0.9445
91496445|NCT03975790|182864348|SUPERIORITY|||||||0.8135|||||||Chi-squared|||Nutritional deficiencies||||0.8135
91702727|NCT02537431|183299962|OTHER||LS mean|50.46|||||TWO_SIDED|95.0|23.69|77.23|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||77.23|23.69|
91702728|NCT02537431|183299962|OTHER||LS mean|41.36|||||TWO_SIDED|95.0|18.69|64.03|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||64.03|18.69|
91702729|NCT02537431|183299962|OTHER||LS mean|26.2|||||TWO_SIDED|95.0|6.76|45.64|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||45.64|6.76|
91702730|NCT02537431|183299963|OTHER||LS Mean|464.84|||||TWO_SIDED|95.0|343.92|585.77|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||585.77|343.92|
91702731|NCT02537431|183299963|OTHER||LS Mean|404.13|||||TWO_SIDED|95.0|294.47|513.78|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||513.78|294.47|
91496446|NCT03975790|182864348|SUPERIORITY|||||||0.6705|||||||Chi-squared|||Nutritional deficiencies||||0.6705
91496447|NCT03975790|182864348|SUPERIORITY|||||||0.8331|||||||Chi-squared|||Nutritional deficiencies||||0.8331
91496448|NCT03975790|182864348|SUPERIORITY|||||||0.4158|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.4158
91496449|NCT03975790|182864348|SUPERIORITY|||||||0.636|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.6360
91496450|NCT03975790|182864348|SUPERIORITY|||||||0.3336|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.3336
91496451|NCT03975790|182864348|SUPERIORITY|||||||0.6402|||||||Chi-squared|||Diabetes mellitus without complication||||0.6402
91702732|NCT02537431|183299963|OTHER||LS Mean|175.13|||<|0.0001|TWO_SIDED|95.0|88.85|261.41|||GEE model||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||261.41|88.85|< 0.0001
91702733|NCT02537431|183299963|OTHER||LS mean|143.11|||||TWO_SIDED|95.0|-38.2|324.41|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||324.41|-38.20|
91702734|NCT02537431|183299963|OTHER||LS mean|76.8|||||TWO_SIDED|95.0|-35.62|189.22|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||189.22|-35.62|
91702735|NCT02537431|183299963|OTHER||LS mean|-41.32|||||TWO_SIDED|95.0|-204.28|121.64|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||121.64|-204.28|
91702736|NCT02537431|183299964|OTHER||LS Mean|89.68|||||TWO_SIDED|95.0|63.58|115.78|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||115.78|63.58|
91702737|NCT02537431|183299964|OTHER||LS Mean|70.17|||||TWO_SIDED|95.0|49.9|90.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||90.44|49.90|
91702738|NCT02537431|183299964|OTHER||LS Mean|35.86|||<|0.0001|TWO_SIDED|95.0|21.37|50.36|||GEE model||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||50.36|21.37|< 0.0001
91702739|NCT02537431|183299964|OTHER||LS mean|34.0|||||TWO_SIDED|95.0|6.53|61.47|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||61.47|6.53|
91702740|NCT02537431|183299964|OTHER||LS mean|25.86|||||TWO_SIDED|95.0|9.27|42.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||42.44|9.27|
91702741|NCT02537431|183299964|OTHER||LS mean|17.88|||||TWO_SIDED|95.0|-0.32|36.07|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||36.07|-0.32|
91702742|NCT02537431|183299965|OTHER||LS Mean|10.93|||||TWO_SIDED|95.0|3.98|17.89|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||17.89|3.98|
91496452|NCT03975790|182864348|SUPERIORITY|||||||0.8068|||||||Chi-squared|||Diabetes mellitus without complication||||0.8068
91496453|NCT03975790|182864348|SUPERIORITY|||||||0.5983|||||||Chi-squared|||Diabetes mellitus without complication||||0.5983
91496454|NCT03975790|182864348|SUPERIORITY|||||||0.9759|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.9759
91496455|NCT03975790|182864348|SUPERIORITY|||||||0.136|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1360
91496456|NCT03975790|182864348|SUPERIORITY|||||||0.1815|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1815
91496457|NCT03975790|182864348|SUPERIORITY|||||||0.2731|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.2731
91496458|NCT03975790|182864348|SUPERIORITY|||||||0.8327|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.8327
91496459|NCT03975790|182864348|SUPERIORITY|||||||0.342|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.3420
91496460|NCT03975790|182864349|SUPERIORITY|||||||0.059|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.0590
91496461|NCT03975790|182864349|SUPERIORITY|||||||0.7055|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.7055
91496462|NCT03975790|182864349|SUPERIORITY|||||||0.3088|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.3088
91496463|NCT03975790|182864349|SUPERIORITY|||||||0.0036|||||||Chi-squared|||Other aftercare||||0.0036
91496464|NCT03975790|182864349|SUPERIORITY|||||||0.3772|||||||Chi-squared|||Other aftercare||||0.3772
91496465|NCT03975790|182864349|SUPERIORITY|||||||0.3|||||||Chi-squared|||Other aftercare||||0.3000
91496466|NCT03975790|182864349|SUPERIORITY|||||||0.7354|||||||Chi-squared|||Other connective tissue disease||||0.7354
91702743|NCT02537431|183299965|OTHER||LS Mean|5.82|||||TWO_SIDED|95.0|-0.02|11.66|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||11.66|-0.02|
91702744|NCT02537431|183299965|OTHER||LS Mean|4.5||||0.2592|TWO_SIDED|95.0|-3.32|12.32|||GEE model||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||12.32|-3.32|0.2592
91702745|NCT02537431|183299965|OTHER||LS mean|3.13|||||TWO_SIDED|95.0|-1.64|7.9|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||7.90|-1.64|
91496467|NCT03975790|182864349|SUPERIORITY|||||||0.1435|||||||Chi-squared|||Other connective tissue disease||||0.1435
91496468|NCT03975790|182864349|SUPERIORITY|||||||0.2876|||||||Chi-squared|||Other connective tissue disease||||0.2876
91496469|NCT03975790|182864349|SUPERIORITY|||||||0.2848|||||||Chi-squared|||Other non-traumatic joint disorders||||0.2848
91496470|NCT03975790|182864349|SUPERIORITY|||||||0.183|||||||Chi-squared|||Other non-traumatic joint disorders||||0.1830
91496471|NCT03975790|182864349|SUPERIORITY|||||||0.6453|||||||Chi-squared|||Other non-traumatic joint disorders||||0.6453
91496472|NCT03975790|182864349|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
91702746|NCT02537431|183299965|OTHER||LS mean|1.14|||||TWO_SIDED|95.0|-2.84|5.11|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||5.11|-2.84|
91496473|NCT03975790|182864349|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
91702747|NCT02537431|183299965|OTHER||LS mean|-5.8|||||TWO_SIDED|95.0|-12.46|0.85|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||0.85|-12.46|
91702748|NCT02537431|183299966|OTHER||LS Mean|52.54|||||TWO_SIDED|95.0|21.18|83.9|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||83.90|21.18|
91702749|NCT02537431|183299966|OTHER||LS Mean|31.37|||||TWO_SIDED|95.0|8.23|54.51|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||54.51|8.23|
91702750|NCT02537431|183299966|OTHER||l|24.35||||0.1672|TWO_SIDED|95.0|-10.2|58.9|||GEE model||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||58.90|-10.20|0.1672
91496474|NCT03975790|182864349|SUPERIORITY|||||||0.3422|||||||Chi-squared|||Medical examination/evaluation||||0.3422
91496475|NCT03975790|182864349|SUPERIORITY|||||||0.3465|||||||Chi-squared|||Other suspected conditions||||0.3465
91496476|NCT03975790|182864349|SUPERIORITY|||||||0.4953|||||||Chi-squared|||Other suspected conditions||||0.4953
91496477|NCT03975790|182864349|SUPERIORITY|||||||0.9796|||||||Chi-squared|||Other suspected conditions||||0.9796
91496478|NCT03975790|182864349|SUPERIORITY|||||||0.4187|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4187
91496479|NCT03975790|182864349|SUPERIORITY|||||||0.151|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1510
91496480|NCT03975790|182864349|SUPERIORITY|||||||0.0751|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.0751
91702751|NCT02537431|183299966|OTHER||LS mean|15.13|||||TWO_SIDED|95.0|-11.19|41.46|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||41.46|-11.19|
91702752|NCT02537431|183299966|OTHER||LS mean|6.92|||||TWO_SIDED|95.0|-13.44|27.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||27.28|-13.44|
91702753|NCT02537431|183299966|OTHER||LS mean|-27.3|||||TWO_SIDED|95.0|-52.33|-2.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||-2.28|-52.33|
91702754|NCT01037127|183299987|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|14.1|37.8|||||The estimated value reflects the percentage of particpants with CR and PR.|||37.8|14.1|
91496481|NCT03975790|182864349|SUPERIORITY|||||||0.7577|||||||Chi-squared|||Osteoarthritis||||0.7577
91496482|NCT03975790|182864349|SUPERIORITY|||||||0.802|||||||Chi-squared|||Osteoarthritis||||0.8020
91496483|NCT03975790|182864349|SUPERIORITY|||||||0.9879|||||||Chi-squared|||Osteoarthritis||||0.9879
91496484|NCT03975790|182864349|SUPERIORITY|||||||0.1717|||||||Chi-squared|||Essential hypertension||||0.1717
91496485|NCT03975790|182864349|SUPERIORITY|||||||0.3065|||||||Chi-squared|||Essential hypertension||||0.3065
91496486|NCT03975790|182864349|SUPERIORITY|||||||0.992|||||||Chi-squared|||Essential hypertension||||0.9920
91496487|NCT03975790|182864349|SUPERIORITY|||||||0.4626|||||||Chi-squared|||Residual codes; unclassified||||0.4626
91496488|NCT03975790|182864349|SUPERIORITY|||||||0.8922|||||||Chi-squared|||Residual codes; unclassified||||0.8922
91496489|NCT03975790|182864349|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
91496490|NCT03975790|182864349|SUPERIORITY|||||||0.8212|||||||Chi-squared|||Disorders of lipid metabolism||||0.8212
91496491|NCT03975790|182864349|SUPERIORITY|||||||0.5732|||||||Chi-squared|||Disorders of lipid metabolism||||0.5732
91496492|NCT03975790|182864349|SUPERIORITY|||||||0.7319|||||||Chi-squared|||Disorders of lipid metabolism||||0.7319
91496493|NCT03975790|182864349|SUPERIORITY|||||||0.9272|||||||Chi-squared|||Back problems||||0.9272
91496494|NCT03975790|182864349|SUPERIORITY|||||||0.1441|||||||Chi-squared|||Back problems||||0.1441
91496495|NCT03975790|182864349|SUPERIORITY|||||||0.1859|||||||Chi-squared|||Back problems||||0.1859
91496496|NCT03975790|182864349|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Other upper respiratory infections||||0.3109
91496497|NCT03975790|182864349|SUPERIORITY|||||||0.3313|||||||Chi-squared|||Other upper respiratory infections||||0.3313
91496498|NCT03975790|182864349|SUPERIORITY|||||||0.1279|||||||Chi-squared|||Other upper respiratory infections||||0.1279
91496499|NCT03975790|182864349|SUPERIORITY|||||||0.7575|||||||Chi-squared|||Other lower respiratory disease||||0.7575
91496500|NCT03975790|182864349|SUPERIORITY|||||||0.1583|||||||Chi-squared|||Other lower respiratory disease||||0.1583
91496501|NCT03975790|182864349|SUPERIORITY|||||||0.1569|||||||Chi-squared|||Other lower respiratory disease||||0.1569
91496502|NCT03975790|182864349|SUPERIORITY|||||||0.0745|||||||Chi-squared|||Other nervous system disorders||||0.0745
91496503|NCT03975790|182864349|SUPERIORITY|||||||0.0933|||||||Chi-squared|||Other nervous system disorders||||0.0933
91496504|NCT03975790|182864349|SUPERIORITY|||||||0.791|||||||Chi-squared|||Other nervous system disorders||||0.7910
91702755|NCT01037127|183299988|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|2.1|48.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||48.4|2.1|
91702756|NCT01037127|183299988|SUPERIORITY_OR_OTHER||percentage of participants|27.0|||||TWO_SIDED|95.0|14.6|41.9|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.9|14.6|
91702757|NCT01037127|183299988|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|14.3|41.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.4|14.3|
91702758|NCT01037127|183299988|SUPERIORITY_OR_OTHER||percentage of participants|28.0|||||TWO_SIDED|95.0|14.2|45.2|||||The estimated value reflects the percentage of particpants with CR and PR.|||45.2|14.2|
91702759|NCT01037127|183299989|SUPERIORITY_OR_OTHER||percentage of participants|20.0||||||95.0|7.7|38.6|||||The estimated value reflects the percentage of particpants with CR and PR.|||38.6|7.7|
91702760|NCT01254851|183300018|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.39||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.70
91702761|NCT02326298|183300019|SUPERIORITY||Odds Ratio (OR)|28.962|||<|0.0001|TWO_SIDED|97.5|6.968|120.371||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||120.371|6.968|<0.0001
91702762|NCT02326298|183300019|SUPERIORITY||Odds Ratio (OR)|45.66|||<|0.0001|TWO_SIDED|97.5|10.657|195.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||195.634|10.657|<0.0001
91702763|NCT02326298|183300019|SUPERIORITY||Estimated difference in responder rate|60.0|||||TWO_SIDED|95.0|47.92|72.17|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||72.17|47.92|
91702764|NCT02326298|183300019|SUPERIORITY||Estimated difference in responder rate|69.3|||||TWO_SIDED|95.0|57.65|80.99|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||80.99|57.65|
91702765|NCT02326298|183300020|SUPERIORITY||Odds Ratio (OR)|20.116|||<|0.0001|TWO_SIDED|97.5|3.699|109.399||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||109.399|3.699|<0.0001
91702766|NCT02326298|183300020|SUPERIORITY||Odds Ratio (OR)|31.143|||<|0.0001|TWO_SIDED|97.5|5.687|170.548||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.548|5.687|<0.0001
91702767|NCT02326298|183300020|SUPERIORITY||Estimated difference in responder rate|42.8|||||TWO_SIDED|95.0|30.7|54.86|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.86|30.70|
91702768|NCT02326298|183300020|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|41.33|65.94|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||65.94|41.33|
91705618|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.37|STANDARD_ERROR_OF_MEAN|0.39||0.34||95.0|-0.39|1.14||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.14|-0.39|0.340
91702769|NCT02326298|183300021|SUPERIORITY||Odds Ratio (OR)|36.668|||<|0.0001|TWO_SIDED|97.5|5.717|235.193||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment,region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||235.193|5.717|<0.0001
91702770|NCT02326298|183300021|SUPERIORITY||Odds Ratio (OR)|50.606|||<|0.0001|TWO_SIDED|97.5|7.88|324.988||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.988|7.880|<0.0001
91702771|NCT02326298|183300021|SUPERIORITY||Estimated difference in responder rate|35.4|||||TWO_SIDED|95.0|20.85|49.87|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||49.87|20.85|
91702772|NCT02326298|183300021|SUPERIORITY||Estimated difference in responder rate|43.1|||||TWO_SIDED|95.0|27.56|58.71|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||58.71|27.56|
91702773|NCT02326298|183300022|SUPERIORITY||Adjusted Mean Treatment Differences|-6.0|||<|0.0001|TWO_SIDED|97.5|-8.18|-3.81||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.81|-8.18|<0.0001
91702774|NCT02326298|183300022|SUPERIORITY||Ajusted Mean Treatment Differences|-6.84|||<|0.0001|TWO_SIDED|97.5|-9.05|-4.62||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.62|-9.05|<0.0001
91702775|NCT02889835|183300025|SUPERIORITY|||||||0.686|||||||Log Rank|||Kaplan-Meier analysis was performed to assess survival over 36 months. Test of survival distributions for the three arms were calculated using Log Rank (Mantel-Cox). Sample size is based on guidelines of the American Dental Association for obtaining approval as an amalgam replacement for posterior restorations - minimum of 40 restorations in a minimum of 20 subjects at 18 months. Sample size is based by taking subject attrition into account over the 36 month clinical evaluation.||||0.686
91702776|NCT02889835|183300026|SUPERIORITY|||||||0.701|||||||Kruskal-Wallis|||||||0.701
91702777|NCT02889835|183300027|SUPERIORITY|||||||0.812|||||||Kruskal-Wallis|||||||0.812
91702778|NCT02889835|183300028|SUPERIORITY|||||||0.104|||||||Kruskal-Wallis|||||||0.104
91702779|NCT02889835|183300029|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.440
91702780|NCT02889835|183300030|SUPERIORITY|||||||0.676|||||||Kruskal-Wallis|||||||0.676
91702781|NCT02889835|183300031|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
91702782|NCT02889835|183300032|SUPERIORITY|||||||0.764|||||||Kruskal-Wallis|||||||0.764
91702783|NCT02889835|183300033|SUPERIORITY|||||||0.323|||||||Kruskal-Wallis|||||||0.323
91496505|NCT03975790|182864349|SUPERIORITY|||||||0.6755|||||||Chi-squared|||Other skin disorders||||0.6755
91702784|NCT02889835|183300034|SUPERIORITY|||||||0.714|||||||Kruskal-Wallis|||||||0.714
91702785|NCT02889835|183300035|SUPERIORITY|||||||0.846|||||||Kruskal-Wallis|||||||0.846
91702786|NCT02889835|183300036|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
91702787|NCT02889835|183300037|SUPERIORITY|||||||0.424|||||||Kruskal-Wallis|||||||0.424
91702788|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.527||||0.0211|TWO_SIDED|95.0|0.306|0.908|||Regression, Logistic|||The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.306|0.0211
91702789|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.065|1.092|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.092|1.065|<0.0001
91705619|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.38||0.821|TWO_SIDED|95.0|-0.67|0.84||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.84|-0.67|0.821
91496506|NCT03975790|182864349|SUPERIORITY|||||||0.4183|||||||Chi-squared|||Other skin disorders||||0.4183
91496507|NCT03975790|182864349|SUPERIORITY|||||||0.6749|||||||Chi-squared|||Other skin disorders||||0.6749
91496508|NCT03975790|182864349|SUPERIORITY|||||||0.6626|||||||Chi-squared|||Thyroid disorders||||0.6626
91496509|NCT03975790|182864349|SUPERIORITY|||||||0.5766|||||||Chi-squared|||Thyroid disorders||||0.5766
91496510|NCT03975790|182864349|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Thyroid disorders||||0.8376
91496511|NCT03975790|182864349|SUPERIORITY|||||||0.2857|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.2857
91496512|NCT03975790|182864349|SUPERIORITY|||||||0.956|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.9560
91530785|NCT03660943|182937592|SUPERIORITY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.506||0.0163|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||-0.23|-2.22|0.0163
91496513|NCT03975790|182864349|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.4384
91496514|NCT03975790|182864349|SUPERIORITY|||||||0.6082|||||||Chi-squared|||Malaise/fatigue||||0.6082
91702790|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0053|TWO_SIDED|95.0|1.061|1.403|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.403|1.061|0.0053
91702791|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.464||||0.0079|TWO_SIDED|95.0|0.264|0.818|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.818|0.264|0.0079
91702792|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.737||||0.1808|TWO_SIDED|95.0|0.471|1.153|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.153|0.471|0.1808
91702793|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.082|||<|0.0001|TWO_SIDED|95.0|1.069|1.095|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.095|1.069|<0.0001
91702794|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.676||||0.0005|TWO_SIDED|95.0|0.542|0.844|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.844|0.542|0.0005
91702795|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.573||||0.0041|TWO_SIDED|95.0|0.392|0.838|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.838|0.392|0.0041
91702796|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.048|1.142|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.142|1.048|<0.0001
91496515|NCT03975790|182864349|SUPERIORITY|||||||0.3374|||||||Chi-squared|||Malaise/fatigue||||0.3374
91496516|NCT03975790|182864349|SUPERIORITY|||||||0.5984|||||||Chi-squared|||Malaise/fatigue||||0.5984
91496517|NCT03975790|182864349|SUPERIORITY|||||||0.8568|||||||Chi-squared|||Esophageal disorders||||0.8568
91496518|NCT03975790|182864349|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Esophageal disorders||||0.7698
91496519|NCT03975790|182864349|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Esophageal disorders||||0.7089
91496520|NCT03975790|182864349|SUPERIORITY|||||||0.3446|||||||Chi-squared|||Nutritional deficiencies||||0.3446
91496521|NCT03975790|182864349|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Nutritional deficiencies||||0.0815
91496522|NCT03975790|182864349|SUPERIORITY|||||||0.402|||||||Chi-squared|||Nutritional deficiencies||||0.4020
91496523|NCT03975790|182864349|SUPERIORITY|||||||0.4246|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.4246
91496524|NCT03975790|182864349|SUPERIORITY|||||||0.8118|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.8118
91496525|NCT03975790|182864349|SUPERIORITY|||||||0.7454|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.7454
91496526|NCT03975790|182864349|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Diabetes mellitus without complication||||0.3559
91496527|NCT03975790|182864349|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Diabetes mellitus without complication||||0.7698
91496528|NCT03975790|182864349|SUPERIORITY|||||||0.7323|||||||Chi-squared|||Diabetes mellitus without complication||||0.7323
91496529|NCT03975790|182864349|SUPERIORITY|||||||0.5935|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.5935
91496530|NCT03975790|182864349|SUPERIORITY|||||||0.3928|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.3928
91496531|NCT03975790|182864349|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.7089
91496532|NCT03975790|182864349|SUPERIORITY|||||||0.8746|||||||Chi-squared|||Other upper respiratory disease||||0.8746
91530786|NCT03660943|182937593|SUPERIORITY||Mean Difference (Final Values)|-7.99|STANDARD_ERROR_OF_MEAN|4.076||0.0509|TWO_SIDED|95.0|-16.01|0.03|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.03|-16.01|0.0509
91702797|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.945||||0.0031|TWO_SIDED|95.0|2.013|31.359|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||31.359|2.013|0.0031
91702798|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.0012|TWO_SIDED|95.0|0.844|0.959|||Regression, Logistic|||The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.959|0.844|0.0012
91702799|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.619||||0.0085|TWO_SIDED|95.0|0.433|0.885|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.885|0.433|0.0085
91702800|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||<|0.0001|TWO_SIDED|95.0|1.087|1.174|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.174|1.087|<0.0001
91702801|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.784||||0.0341|TWO_SIDED|95.0|0.626|0.982|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.982|0.626|0.0341
91702802|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.575||||0.0443|TWO_SIDED|95.0|0.335|0.986|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.986|0.335|0.0443
91702803|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||<|0.0001|TWO_SIDED|95.0|1.057|1.144|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.144|1.057|<0.0001
91702804|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.867||||0.0039|TWO_SIDED|95.0|2.73|191.56|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||191.56|2.730|0.0039
91702805|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.0244|TWO_SIDED|95.0|0.628|0.968|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||0.968|0.628|0.0244
91702806|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128|||<|0.0001|TWO_SIDED|95.0|1.086|1.172|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.172|1.086|<0.0001
91496533|NCT03975790|182864349|SUPERIORITY|||||||0.3835|||||||Chi-squared|||Other upper respiratory disease||||0.3835
91496534|NCT03975790|182864349|SUPERIORITY|||||||0.4992|||||||Chi-squared|||Other upper respiratory disease||||0.4992
91496535|NCT03975790|182864350|SUPERIORITY|||||||0.2336|||||||t-test|||||||0.2336
91496536|NCT03975790|182864350|SUPERIORITY|||||||0.2109|||||||t-test|||||||0.2109
91496537|NCT03975790|182864350|SUPERIORITY|||||||0.0691|||||||t-test|||||||0.0691
91496538|NCT03975790|182864351|SUPERIORITY|||||||0.9758|||||||Chi-squared|||MTX Sodium||||0.9758
91496539|NCT03975790|182864351|SUPERIORITY|||||||0.9978|||||||Chi-squared|||MTX Sodium||||0.9978
91496540|NCT03975790|182864351|SUPERIORITY|||||||0.9861|||||||Chi-squared|||MTX Sodium||||0.9861
91496541|NCT03975790|182864351|SUPERIORITY|||||||0.5744|||||||Chi-squared|||Folic Acid||||0.5744
91496542|NCT03975790|182864351|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Folic Acid||||0.8542
91496543|NCT03975790|182864351|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Folic Acid||||0.8363
91496544|NCT03975790|182864351|SUPERIORITY|||||||0.0473|||||||Chi-squared|||Prednisone||||0.0473
91496545|NCT03975790|182864351|SUPERIORITY|||||||0.0327|||||||Chi-squared|||Prednisone||||0.0327
91705620|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.46|STANDARD_ERROR_OF_MEAN|0.42||0.268|TWO_SIDED|95.0|-0.36|1.28||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.28|-0.36|0.268
91496546|NCT03975790|182864351|SUPERIORITY|||||||0.5348|||||||Chi-squared|||Prednisone||||0.5348
91496547|NCT03975790|182864351|SUPERIORITY|||||||0.6934|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6934
91496548|NCT03975790|182864351|SUPERIORITY|||||||0.6017|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6017
91496549|NCT03975790|182864351|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.4768
91496550|NCT03975790|182864351|SUPERIORITY|||||||0.2315|||||||Chi-squared|||Azithromycin||||0.2315
91496551|NCT03975790|182864351|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Azithromycin||||0.2588
91496552|NCT03975790|182864351|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Azithromycin||||0.8576
91496553|NCT03975790|182864351|SUPERIORITY|||||||0.5909|||||||Chi-squared|||Adalimumab||||0.5909
91496554|NCT03975790|182864351|SUPERIORITY|||||||0.057|||||||Chi-squared|||Adalimumab||||0.0570
91496555|NCT03975790|182864351|SUPERIORITY|||||||0.0408|||||||Chi-squared|||Adalimumab||||0.0408
91496556|NCT03975790|182864351|SUPERIORITY|||||||0.6465|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.6465
91496557|NCT03975790|182864351|SUPERIORITY|||||||0.5654|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.5654
91496558|NCT03975790|182864351|SUPERIORITY|||||||0.8371|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.8371
91496559|NCT03975790|182864351|SUPERIORITY|||||||0.9654|||||||Chi-squared|||Etanercept||||0.9654
91496560|NCT03975790|182864351|SUPERIORITY|||||||0.1013|||||||Chi-squared|||Etanercept||||0.1013
91496561|NCT03975790|182864351|SUPERIORITY|||||||0.158|||||||Chi-squared|||Etanercept||||0.1580
91496562|NCT03975790|182864351|SUPERIORITY|||||||0.1663|||||||Chi-squared|||Levothyroxine Sodium||||0.1663
91496563|NCT03975790|182864351|SUPERIORITY|||||||0.6563|||||||Chi-squared|||Levothyroxine Sodium||||0.6563
91496564|NCT03975790|182864351|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
91496565|NCT03975790|182864351|SUPERIORITY|||||||0.4166|||||||Chi-squared|||Methylprednisolone||||0.4166
91496566|NCT03975790|182864351|SUPERIORITY|||||||0.0636|||||||Chi-squared|||Methylprednisolone||||0.0636
91496567|NCT03975790|182864351|SUPERIORITY|||||||0.3137|||||||Chi-squared|||Methylprednisolone||||0.3137
91496568|NCT03975790|182864351|SUPERIORITY|||||||0.4568|||||||Chi-squared|||Omeprazole||||0.4568
91496569|NCT03975790|182864351|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Omeprazole||||0.5785
91496570|NCT03975790|182864351|SUPERIORITY|||||||0.9541|||||||Chi-squared|||Omeprazole||||0.9541
91496571|NCT03975790|182864351|SUPERIORITY|||||||0.1956|||||||Chi-squared|||Tramadol Hydrochloride||||0.1956
91496572|NCT03975790|182864351|SUPERIORITY|||||||0.3633|||||||Chi-squared|||Tramadol Hydrochloride||||0.3633
91496573|NCT03975790|182864351|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Tramadol Hydrochloride||||0.9481
91496574|NCT03975790|182864351|SUPERIORITY|||||||0.3653|||||||Chi-squared|||Meloxicam||||0.3653
91496575|NCT03975790|182864351|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Meloxicam||||0.9255
91496576|NCT03975790|182864351|SUPERIORITY|||||||0.5137|||||||Chi-squared|||Meloxicam||||0.5137
91496577|NCT03975790|182864351|SUPERIORITY|||||||0.6338|||||||Chi-squared|||Amoxicillin||||0.6338
91496578|NCT03975790|182864351|SUPERIORITY|||||||0.6329|||||||Chi-squared|||Amoxicillin||||0.6329
91496579|NCT03975790|182864351|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Amoxicillin||||0.9228
91496580|NCT03975790|182864351|SUPERIORITY|||||||0.8433|||||||Chi-squared|||Albuterol Sulfate||||0.8433
91496581|NCT03975790|182864351|SUPERIORITY|||||||0.1175|||||||Chi-squared|||Albuterol Sulfate||||0.1175
91496582|NCT03975790|182864351|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Albuterol Sulfate||||0.1215
91496583|NCT03975790|182864351|SUPERIORITY|||||||0.9007|||||||Chi-squared|||Gabapentin||||0.9007
91496584|NCT03975790|182864351|SUPERIORITY|||||||0.8789|||||||Chi-squared|||Gabapentin||||0.8789
91496585|NCT03975790|182864351|SUPERIORITY|||||||0.8305|||||||Chi-squared|||Gabapentin||||0.8305
91496586|NCT03975790|182864351|SUPERIORITY|||||||0.0694|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.0694
91496587|NCT03975790|182864351|SUPERIORITY|||||||0.8606|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.8606
91496588|NCT03975790|182864351|SUPERIORITY|||||||0.3363|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.3363
91496589|NCT03975790|182864351|SUPERIORITY|||||||0.3319|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.3319
91496590|NCT03975790|182864351|SUPERIORITY|||||||0.5615|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.5615
91496591|NCT03975790|182864351|SUPERIORITY|||||||0.8898|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8898
91496592|NCT03975790|182864351|SUPERIORITY|||||||0.367|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.3670
91496593|NCT03975790|182864351|SUPERIORITY|||||||0.8155|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.8155
91496594|NCT03975790|182864351|SUPERIORITY|||||||0.7091|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7091
91496595|NCT03975790|182864351|SUPERIORITY|||||||0.9769|||||||Chi-squared|||Fluticasone Propionate||||0.9769
91496596|NCT03975790|182864351|SUPERIORITY|||||||0.5032|||||||Chi-squared|||Fluticasone Propionate||||0.5032
91496597|NCT03975790|182864351|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Fluticasone Propionate||||0.5631
91496598|NCT03975790|182864351|SUPERIORITY|||||||0.4426|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.4426
91496599|NCT03975790|182864351|SUPERIORITY|||||||0.5734|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5734
91496600|NCT03975790|182864351|SUPERIORITY|||||||0.3071|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.3071
91496601|NCT03975790|182864351|SUPERIORITY|||||||0.1608|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1608
91496602|NCT03975790|182864351|SUPERIORITY|||||||0.4092|||||||Chi-squared|||Duloxetine Hydrochloride||||0.4092
91496603|NCT03975790|182864351|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1215
91496604|NCT03975790|182864351|SUPERIORITY|||||||0.7279|||||||Chi-squared|||Atorvastatin Calcium||||0.7279
91496605|NCT03975790|182864351|SUPERIORITY|||||||0.7703|||||||Chi-squared|||Atorvastatin Calcium||||0.7703
91496606|NCT03975790|182864351|SUPERIORITY|||||||0.6254|||||||Chi-squared|||Atorvastatin Calcium||||0.6254
91496607|NCT03975790|182864351|SUPERIORITY|||||||0.1615|||||||Chi-squared|||Diclofenac Sodium||||0.1615
91496608|NCT03975790|182864351|SUPERIORITY|||||||0.505|||||||Chi-squared|||Diclofenac Sodium||||0.5050
91496609|NCT03975790|182864351|SUPERIORITY|||||||0.1592|||||||Chi-squared|||Diclofenac Sodium||||0.1592
91496610|NCT03975790|182864351|SUPERIORITY|||||||0.6088|||||||Chi-squared|||Levofloxacin||||0.6088
91496611|NCT03975790|182864351|SUPERIORITY|||||||0.4713|||||||Chi-squared|||Levofloxacin||||0.4713
91496612|NCT03975790|182864351|SUPERIORITY|||||||0.3399|||||||Chi-squared|||Levofloxacin||||0.3399
91496613|NCT03975790|182864352|SUPERIORITY|||||||0.2349|||||||Chi-squared|||MTX Sodium||||0.2349
91496614|NCT03975790|182864352|SUPERIORITY|||||||0.3956|||||||Chi-squared|||MTX Sodium||||0.3956
91496615|NCT03975790|182864352|SUPERIORITY|||||||0.55|||||||Chi-squared|||Folic Acid||||0.5500
91496616|NCT03975790|182864352|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Folic Acid||||0.7131
91496617|NCT03975790|182864352|SUPERIORITY|||||||0.942|||||||Chi-squared|||Folic Acid||||0.9420
91496618|NCT03975790|182864352|SUPERIORITY|||||||0.0571|||||||Chi-squared|||Prednisone||||0.0571
91496619|NCT03975790|182864352|SUPERIORITY|||||||0.049|||||||Chi-squared|||Prednisone||||0.0490
91496620|NCT03975790|182864352|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Prednisone||||0.5631
91496621|NCT03975790|182864352|SUPERIORITY|||||||0.2198|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.2198
91496622|NCT03975790|182864352|SUPERIORITY|||||||0.385|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.3850
91496623|NCT03975790|182864352|SUPERIORITY|||||||0.1165|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.1165
91496624|NCT03975790|182864352|SUPERIORITY|||||||0.4291|||||||Chi-squared|||Azithromycin||||0.4291
91496625|NCT03975790|182864352|SUPERIORITY|||||||0.385|||||||Chi-squared|||Azithromycin||||0.3850
91496626|NCT03975790|182864352|SUPERIORITY|||||||0.8143|||||||Chi-squared|||Azithromycin||||0.8143
91496627|NCT03975790|182864352|SUPERIORITY|||||||0.7272|||||||Chi-squared|||Adalimumab||||0.7272
91736264|NCT00560417|183365535|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.006
91736265|NCT00560417|183365535|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.004
91736266|NCT00560417|183365536|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||p-value is for endpoint.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)||||||0.343
91736267|NCT00560417|183365537|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||p-value is for the change in body weight at endpoint in the ILPS treatment group.|t-test, 2 sided|||||||0.417
91736268|NCT00560417|183365537|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||p-value is for the change in body weight at endpoint in the glargine treatment group.|t-test, 2 sided|||||||0.041
91496628|NCT03975790|182864352|SUPERIORITY|||||||0.0501|||||||Chi-squared|||Adalimumab||||0.0501
91496629|NCT03975790|182864352|SUPERIORITY|||||||0.05|||||||Chi-squared|||Adalimumab||||0.0500
91496630|NCT03975790|182864352|SUPERIORITY|||||||0.3116|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.3116
91496631|NCT03975790|182864352|SUPERIORITY|||||||0.4882|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.4882
91496632|NCT03975790|182864352|SUPERIORITY|||||||0.9505|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.9505
91736269|NCT00560417|183365537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.343|TWO_SIDED|95.0|-1.15|0.4||p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.|ANOVA|||||0.40|-1.15|0.343
91736270|NCT00560417|183365538|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group||||||<0.001
91496633|NCT03975790|182864352|SUPERIORITY|||||||0.408|||||||Chi-squared|||Etanercept||||0.4080
91496634|NCT03975790|182864352|SUPERIORITY|||||||0.7644|||||||Chi-squared|||Etanercept||||0.7644
91496635|NCT03975790|182864352|SUPERIORITY|||||||0.4146|||||||Chi-squared|||Etanercept||||0.4146
91496636|NCT03975790|182864352|SUPERIORITY|||||||0.1348|||||||Chi-squared|||Levothyroxine Sodium||||0.1348
91496637|NCT03975790|182864352|SUPERIORITY|||||||0.5948|||||||Chi-squared|||Levothyroxine Sodium||||0.5948
91496638|NCT03975790|182864352|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
91496639|NCT03975790|182864352|SUPERIORITY|||||||0.1033|||||||Chi-squared|||Methylprednisolone||||0.1033
91496640|NCT03975790|182864352|SUPERIORITY|||||||0.2117|||||||Chi-squared|||Methylprednisolone||||0.2117
91496641|NCT03975790|182864352|SUPERIORITY|||||||0.992|||||||Chi-squared|||Methylprednisolone||||0.9920
91530787|NCT03699124|182937594|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.816|1.073||||||||1.073|0.816|
91496642|NCT03975790|182864352|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
91496643|NCT03975790|182864352|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
91496644|NCT03975790|182864352|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Omeprazole||||0.4384
91496645|NCT03975790|182864352|SUPERIORITY|||||||0.0162|||||||Chi-squared|||Tramadol Hydrochloride||||0.0162
91496646|NCT03975790|182864352|SUPERIORITY|||||||0.3239|||||||Chi-squared|||Tramadol Hydrochloride||||0.3239
91496647|NCT03975790|182864352|SUPERIORITY|||||||0.4837|||||||Chi-squared|||Tramadol Hydrochloride||||0.4837
91496648|NCT03975790|182864352|SUPERIORITY|||||||0.7183|||||||Chi-squared|||Meloxicam||||0.7183
91496649|NCT03975790|182864352|SUPERIORITY|||||||0.2667|||||||Chi-squared|||Meloxicam||||0.2667
91736271|NCT00583219|183365548|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline at one month||||0.004
91736272|NCT00583219|183365548|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.81
91736273|NCT00583219|183365549|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.21
91736274|NCT00583219|183365549|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.43
91736275|NCT00583219|183365551|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.005
91736276|NCT00583219|183365552|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.22
91736277|NCT00583219|183365553|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
91736278|NCT00583219|183365553|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.14
91736279|NCT00583219|183365554|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
91736280|NCT00583219|183365554|SUPERIORITY_OR_OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.033
91736281|NCT00583219|183365555|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Exact binomial sign test|||P value change from baseline to 1 month||||>0.99
91496650|NCT03975790|182864352|SUPERIORITY|||||||0.451|||||||Chi-squared|||Meloxicam||||0.4510
91496651|NCT03975790|182864352|SUPERIORITY|||||||0.7993|||||||Chi-squared|||Amoxicillin||||0.7993
91496652|NCT03975790|182864352|SUPERIORITY|||||||0.9896|||||||Chi-squared|||Amoxicillin||||0.9896
91496653|NCT03975790|182864352|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Amoxicillin||||0.8576
91530788|NCT03699124|182937594|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.115|||||TWO_SIDED|95.0|0.967|1.287||||||||1.287|0.967|
91530789|NCT03699124|182937594|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.044|||||TWO_SIDED|95.0|0.915|1.191||||||||1.191|0.915|
91530790|NCT00688259|182937649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||||||.30
91496654|NCT03975790|182864352|SUPERIORITY|||||||0.9373|||||||Chi-squared|||Albuterol Sulfate||||0.9373
91496655|NCT03975790|182864352|SUPERIORITY|||||||0.1253|||||||Chi-squared|||Albuterol Sulfate||||0.1253
91496656|NCT03975790|182864352|SUPERIORITY|||||||0.1851|||||||Chi-squared|||Albuterol Sulfate||||0.1851
91530791|NCT00688259|182937650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||.09
91530792|NCT00688259|182937651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46|||||||Mixed Models Analysis|||||||.46
91736282|NCT00583219|183365555|SUPERIORITY_OR_OTHER|||||||0.25|||||||exact binomial sign test|||P value change from baseline to 3 months||||0.25
91530793|NCT00688259|182937652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Mixed Models Analysis|||||||.55
91530794|NCT00688259|182937653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||.50
91530795|NCT00688259|182937654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||Mixed Models Analysis|||||||.25
91530796|NCT01058863|182937660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.88|1.42||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.42|0.88|<0.0001
91496657|NCT03975790|182864352|SUPERIORITY|||||||0.8697|||||||Chi-squared|||Gabapentin||||0.8697
91496658|NCT03975790|182864352|SUPERIORITY|||||||0.9719|||||||Chi-squared|||Gabapentin||||0.9719
91705621|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.998|TWO_SIDED|95.0|-0.8|0.8||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.80|-0.80|0.998
91496659|NCT03975790|182864352|SUPERIORITY|||||||0.938|||||||Chi-squared|||Gabapentin||||0.9380
91496660|NCT03975790|182864352|SUPERIORITY|||||||0.1079|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.1079
91496661|NCT03975790|182864352|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.2588
91496662|NCT03975790|182864352|SUPERIORITY|||||||0.9358|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.9358
91496663|NCT03975790|182864352|SUPERIORITY|||||||0.1984|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.1984
91496664|NCT03975790|182864352|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8542
91496665|NCT03975790|182864352|SUPERIORITY|||||||0.2973|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.2973
91496666|NCT03975790|182864352|SUPERIORITY|||||||0.1046|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.1046
91496667|NCT03975790|182864352|SUPERIORITY|||||||0.7961|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7961
91496668|NCT03975790|182864352|SUPERIORITY|||||||0.214|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.2140
91496669|NCT03975790|182864352|SUPERIORITY|||||||0.8578|||||||Chi-squared|||Fluticasone Propionate||||0.8578
91496670|NCT03975790|182864352|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Fluticasone Propionate||||0.7131
91496671|NCT03975790|182864352|SUPERIORITY|||||||0.8421|||||||Chi-squared|||Fluticasone Propionate||||0.8421
91496672|NCT03975790|182864352|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.7637
91496673|NCT03975790|182864352|SUPERIORITY|||||||0.6355|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.6355
91496674|NCT03975790|182864352|SUPERIORITY|||||||0.5425|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5425
91496675|NCT03975790|182864352|SUPERIORITY|||||||0.041|||||||Chi-squared|||Duloxetine Hydrochloride||||0.0410
91496676|NCT03975790|182864352|SUPERIORITY|||||||0.8251|||||||Chi-squared|||Duloxetine Hydrochloride||||0.8251
91496677|NCT03975790|182864352|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Duloxetine Hydrochloride||||0.2871
91496678|NCT03975790|182864352|SUPERIORITY|||||||0.1174|||||||Chi-squared|||Diclofenac Sodium||||0.1174
91496679|NCT03975790|182864352|SUPERIORITY|||||||0.9702|||||||Chi-squared|||Diclofenac Sodium||||0.9702
91496680|NCT03975790|182864352|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Diclofenac Sodium||||0.3109
91496681|NCT03975790|182864352|SUPERIORITY|||||||0.6744|||||||Chi-squared|||Levofloxacin||||0.6744
91496682|NCT03975790|182864352|SUPERIORITY|||||||0.8121|||||||Chi-squared|||Levofloxacin||||0.8121
91705622|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.42||0.728|TWO_SIDED|95.0|-0.68|0.97||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.97|-0.68|0.728
91705623|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.52|STANDARD_ERROR_OF_MEAN|0.41||0.203|TWO_SIDED|95.0|-1.33|0.28||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.28|-1.33|0.203
91736283|NCT00583219|183365557|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||<0.001
91736284|NCT00583219|183365558|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.004
91736285|NCT00583219|183365559|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.003
91736286|NCT00583219|183365559|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months.||||0.001
91702807|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.547||||0.0453|TWO_SIDED|95.0|0.303|0.987|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.987|0.303|0.0453
91702808|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.133||||0.0184|TWO_SIDED|95.0|0.025|0.712|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.712|0.025|0.0184
91702809|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103|||<|0.0001|TWO_SIDED|95.0|1.072|1.134|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.134|1.072|<0.0001
91736287|NCT00583219|183365560|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||0.001
91736288|NCT00583219|183365560|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||<0.001
91702810|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.543||||0.0019|TWO_SIDED|95.0|0.37|0.798|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.798|0.370|0.0019
91702811|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.0017|TWO_SIDED|95.0|0.189|0.679|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.679|0.189|0.0017
91702812|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|||<|0.0001|TWO_SIDED|95.0|1.047|1.114|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.114|1.047|<0.0001
91702813|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.0042|TWO_SIDED|95.0|1.029|1.162|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.162|1.029|0.0042
91702814|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.0168|TWO_SIDED|95.0|0.32|0.893|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.893|0.320|0.0168
91702815|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.501||||0.0128|TWO_SIDED|95.0|0.291|0.864|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.864|0.291|0.0128
91736289|NCT00583219|183365561|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month.||||0.007
91736290|NCT00583219|183365561|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.002
91736291|NCT02037529|183365564|SUPERIORITY|||||||0.5623|||||||Log Rank|||||||0.5623
91736292|NCT02037529|183365569|SUPERIORITY|||||||0.984|||||||Log Rank|||||||0.9840
91736293|NCT02037529|183365570|SUPERIORITY|||||||0.5968|||||||Log Rank|||||||0.5968
91736294|NCT02384421|183365574|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91736295|NCT02384421|183365575|SUPERIORITY|||||||0.0064|||||||t-test, 2 sided|||||||0.0064
91736296|NCT02384421|183365576|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91736297|NCT02384421|183365577|SUPERIORITY|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.25
91736298|NCT02384421|183365578|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91736299|NCT02384421|183365579|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91736300|NCT00718315|183365580|SUPERIORITY_OR_OTHER|||||||0.481||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.481
91736301|NCT00718315|183365580|SUPERIORITY_OR_OTHER|||||||0.933||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.933
91736302|NCT00718315|183365580|SUPERIORITY_OR_OTHER|||||||0.986||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.986
91736303|NCT00718315|183365582|SUPERIORITY_OR_OTHER|||||||0.095|||||||Log Rank|||||||0.095
91736304|NCT00718315|183365583|SUPERIORITY_OR_OTHER|||||||0.199|||||||Chi-squared|||||||0.199
91736305|NCT00718315|183365584|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||||||0.108
91496683|NCT03975790|182864352|SUPERIORITY|||||||0.9451|||||||Chi-squared|||Levofloxacin||||0.9451
91496684|NCT03975790|182864352|SUPERIORITY|||||||0.166|||||||Chi-squared|||Cephalexin||||0.1660
91496685|NCT03975790|182864352|SUPERIORITY|||||||0.9549|||||||Chi-squared|||Cephalexin||||0.9549
91496686|NCT03975790|182864352|SUPERIORITY|||||||0.3104|||||||Chi-squared|||Cephalexin||||0.3104
91496687|NCT03975790|182864352|SUPERIORITY|||||||0.0489|||||||Chi-squared|||Ibuprofen||||0.0489
91496688|NCT03975790|182864352|SUPERIORITY|||||||0.1515|||||||Chi-squared|||Ibuprofen||||0.1515
91496689|NCT03975790|182864352|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Ibuprofen||||0.9481
91496690|NCT03975790|182864353|SUPERIORITY|||||||0.2178|||||||Chi-squared|||||||0.2178
91496691|NCT03975790|182864353|SUPERIORITY|||||||0.5237|||||||Chi-squared|||||||0.5237
91496692|NCT03975790|182864353|SUPERIORITY|||||||0.7964|||||||Chi-squared|||||||0.7964
91496693|NCT03975790|182864354|SUPERIORITY|||||||0.9085|||||||Chi-squared|||||||0.9085
91736306|NCT00718315|183365585|SUPERIORITY_OR_OTHER|||||||0.179|||||||Chi-squared|||||||0.179
91496694|NCT03975790|182864354|SUPERIORITY|||||||0.6283|||||||Chi-squared|||||||0.6283
91496695|NCT03975790|182864354|SUPERIORITY|||||||0.7293|||||||Chi-squared|||||||0.7293
91496696|NCT03975790|182864355|SUPERIORITY|||||||0.9392|||||||Chi-squared|||||||0.9392
91496697|NCT03975790|182864355|SUPERIORITY|||||||0.3063|||||||Chi-squared|||||||0.3063
91496698|NCT03975790|182864355|SUPERIORITY|||||||0.3467|||||||Chi-squared|||||||0.3467
91496699|NCT03975790|182864356|SUPERIORITY|||||||0.7977|||||||Chi-squared|||||||0.7977
91530797|NCT01058863|182937660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.7|1.24||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.24|0.70|<0.0001
91736307|NCT00718315|183365586|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
91736308|NCT00718315|183365587|SUPERIORITY_OR_OTHER|||||||0.087|||||||Kruskal-Wallis|||||||0.087
91736309|NCT00718315|183365588|SUPERIORITY_OR_OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
91736310|NCT01164007|183365592|SUPERIORITY_OR_OTHER|||||||0.071|||||||One-sample exact binomial test|||The observed percentage of participants with CR or PR was compared with the expected proportion under the null hypothesis (0.10) and analyzed for statistical significance using a one-sample exact binomial test.||||0.071
91736311|NCT02319486|183365608|SUPERIORITY_OR_OTHER||Probability of Event-Free Survival ，pEFS|0.32||||0.034|TWO_SIDED|||||stage 2 vs stage 3|pEFS||over all pEFS|||||0.034
91496700|NCT03975790|182864356|SUPERIORITY|||||||0.5241|||||||Chi-squared|||||||0.5241
91496701|NCT03975790|182864356|SUPERIORITY|||||||0.4702|||||||Chi-squared|||||||0.4702
91496702|NCT03975790|182864357|SUPERIORITY|||||||0.1461|||||||t-test|||||||0.1461
91496703|NCT03975790|182864357|SUPERIORITY|||||||0.1411|||||||t-test|||||||0.1411
91496704|NCT03975790|182864357|SUPERIORITY|||||||0.4201|||||||t-test|||||||0.4201
91496705|NCT03975790|182864358|SUPERIORITY|||||||0.3955|||||||t-test|||||||0.3955
91496706|NCT03975790|182864358|SUPERIORITY|||||||0.6356|||||||t-test|||||||0.6356
91496707|NCT03975790|182864358|SUPERIORITY|||||||0.3833|||||||t-test|||||||0.3833
91496708|NCT03975790|182864359|SUPERIORITY|||||||0.3292|||||||t-test|||||||0.3292
91496709|NCT03975790|182864359|SUPERIORITY|||||||0.2959|||||||t-test|||||||0.2959
91496710|NCT03975790|182864359|SUPERIORITY|||||||0.6962|||||||t-test|||||||0.6962
91496711|NCT03975790|182864360|SUPERIORITY|||||||0.8138|||||||t-test|||||||0.8138
91496712|NCT03975790|182864360|SUPERIORITY|||||||0.007|||||||t-test|||||||0.0070
91496713|NCT03975790|182864360|SUPERIORITY|||||||0.0358|||||||t-test|||||||0.0358
91496714|NCT03975790|182864361|SUPERIORITY|||||||0.8453|||||||t-test|||||||0.8453
91496715|NCT03975790|182864361|SUPERIORITY|||||||0.4806|||||||t-test|||||||0.4806
91496716|NCT03975790|182864361|SUPERIORITY|||||||0.4809|||||||t-test|||||||0.4809
91496717|NCT03975790|182864362|SUPERIORITY|||||||0.3076|||||||t-test|||||||0.3076
91496718|NCT03975790|182864362|SUPERIORITY|||||||0.2509|||||||t-test|||||||0.2509
91496719|NCT03975790|182864362|SUPERIORITY|||||||0.7827|||||||t-test|||||||0.7827
91496720|NCT03975790|182864363|SUPERIORITY|||||||0.4261|||||||Chi-squared|||During Persistency||||0.4261
91496721|NCT03975790|182864363|SUPERIORITY|||||||0.5247|||||||Chi-squared|||During Persistency||||0.5247
91496722|NCT03975790|182864363|SUPERIORITY|||||||0.2809|||||||Chi-squared|||During Persistency||||0.2809
91496723|NCT03975790|182864363|SUPERIORITY|||||||0.1153|||||||Chi-squared|||Post Persistency||||0.1153
91496724|NCT03975790|182864363|SUPERIORITY|||||||0.1344|||||||Chi-squared|||Post Persistency||||0.1344
91496725|NCT03975790|182864363|SUPERIORITY|||||||0.8229|||||||Chi-squared|||Post Persistency||||0.8229
91496726|NCT03975790|182864364|SUPERIORITY|||||||0.7816|||||||Chi-squared|||During Persistency||||0.7816
91496727|NCT03975790|182864364|SUPERIORITY|||||||0.7124|||||||Chi-squared|||During Persistency||||0.7124
91496728|NCT03975790|182864364|SUPERIORITY|||||||0.6148|||||||Chi-squared|||During Persistency||||0.6148
91496729|NCT03975790|182864364|SUPERIORITY|||||||0.4876|||||||Chi-squared|||Post Persistency||||0.4876
91496730|NCT03975790|182864364|SUPERIORITY|||||||0.7826|||||||Chi-squared|||Post Persistency||||0.7826
91496731|NCT03975790|182864364|SUPERIORITY|||||||0.8337|||||||Chi-squared|||Post Persistency||||0.8337
91496732|NCT03975790|182864365|SUPERIORITY|||||||0.1344|||||||Chi-squared|||||||0.1344
91496733|NCT03975790|182864365|SUPERIORITY|||||||0.0095|||||||Chi-squared|||||||0.0095
91496734|NCT03975790|182864365|SUPERIORITY|||||||0.1406|||||||Chi-squared|||||||0.1406
91496735|NCT03975790|182864366|SUPERIORITY|||||||0.9379|||||||Chi-squared|||||||0.9379
91496736|NCT03975790|182864366|SUPERIORITY|||||||0.3025|||||||Chi-squared|||||||0.3025
91496737|NCT03975790|182864366|SUPERIORITY|||||||0.3388|||||||Chi-squared|||||||0.3388
91496738|NCT03975790|182864367|SUPERIORITY|||||||0.8205|||||||t-test|||||||0.8205
91496739|NCT03975790|182864367|SUPERIORITY|||||||0.0467|||||||t-test|||||||0.0467
91496740|NCT03975790|182864367|SUPERIORITY|||||||0.1083|||||||t-test|||||||0.1083
91496741|NCT03975790|182864368|SUPERIORITY|||||||0.8899|||||||t-test|||||||0.8899
91496742|NCT03975790|182864368|SUPERIORITY|||||||0.6183|||||||t-test|||||||0.6183
91496743|NCT03975790|182864368|SUPERIORITY|||||||0.6496|||||||t-test|||||||0.6496
91496744|NCT03975790|182864369|SUPERIORITY|||||||0.5027|||||||t-test|||||||0.5027
91496745|NCT03975790|182864369|SUPERIORITY|||||||0.2375|||||||t-test|||||||0.2375
91496746|NCT03975790|182864369|SUPERIORITY|||||||0.5577|||||||t-test|||||||0.5577
91496747|NCT03975790|182864370|SUPERIORITY|||||||0.6908|||||||t-test|||||||0.6908
91736312|NCT03767881|183365659|NON_INFERIORITY|The upper limit of a 97.8% confidence limit of the mean days to resolution of acute cholecystitis is compared to a Performance Goal of 3.5 days.|Mean Difference (Final Values)|3.5|||||ONE_SIDED|97.8||10.78|||t-test, 1 sided|||||10.78||
91496748|NCT03975790|182864370|SUPERIORITY|||||||0.0859|||||||t-test|||||||0.0859
91496749|NCT03975790|182864370|SUPERIORITY|||||||0.2764|||||||t-test|||||||0.2764
91496750|NCT03975790|182864371|SUPERIORITY|||||||0.1906|||||||t-test|||||||0.1906
91496751|NCT03975790|182864371|SUPERIORITY|||||||0.8744|||||||t-test|||||||0.8744
91496752|NCT03975790|182864371|SUPERIORITY|||||||0.3295|||||||t-test|||||||0.3295
91496753|NCT03975790|182864372|SUPERIORITY|||||||0.0056|||||||t-test|||All cause||||0.0056
91496754|NCT03975790|182864372|SUPERIORITY|||||||0.4222|||||||t-test|||All cause||||0.4222
91736313|NCT03767881|183365660|NON_INFERIORITY|The upper limit of a 99.7% confidence limit of the proportion of patients with reintervention, including migration and occlusion, is compared to a Performance Goal of 46.2%.|Performance Goal|16.7|||||ONE_SIDED|99.7||42.0|||1-sided Clopper-Pearson 99.7% CI|||||42.0||
91496755|NCT03975790|182864372|SUPERIORITY|||||||0.0041|||||||t-test|||All cause||||0.0041
91496756|NCT03975790|182864372|SUPERIORITY|||||||0.2277|||||||t-test|||RA related||||0.2277
91496757|NCT03975790|182864372|SUPERIORITY|||||||0.2812|||||||t-test|||RA related||||0.2812
91496758|NCT03975790|182864372|SUPERIORITY|||||||0.0772|||||||t-test|||RA related||||0.0772
91496759|NCT03975790|182864373|SUPERIORITY|||||||0.293|||||||t-test|||All cause||||0.2930
91496760|NCT03975790|182864373|SUPERIORITY|||||||0.439|||||||t-test|||All cause||||0.4390
91496761|NCT03975790|182864373|SUPERIORITY|||||||0.153|||||||t-test|||All cause||||0.1530
91496762|NCT03975790|182864373|SUPERIORITY|||||||0.9439|||||||t-test|||RA related||||0.9439
91760047|NCT01393639|183411992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|-0.01|0.44||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.01|
91496763|NCT03975790|182864373|SUPERIORITY|||||||0.4477|||||||t-test|||RA related||||0.4477
91496764|NCT03975790|182864373|SUPERIORITY|||||||0.4519|||||||t-test|||RA related||||0.4519
91496765|NCT03975790|182864374|SUPERIORITY|||||||0.9829|||||||Chi-squared|||Cardiovascular Disease||||0.9829
91496766|NCT03975790|182864374|SUPERIORITY|||||||0.8021|||||||Chi-squared|||Cardiovascular Disease||||0.8021
91496767|NCT03975790|182864374|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Cardiovascular Disease||||0.8376
91496768|NCT03975790|182864374|SUPERIORITY|||||||0.5927|||||||Chi-squared|||COPD||||0.5927
91496769|NCT03975790|182864374|SUPERIORITY|||||||0.5202|||||||Chi-squared|||COPD||||0.5202
91496770|NCT03975790|182864374|SUPERIORITY|||||||0.8517|||||||Chi-squared|||COPD||||0.8517
91496771|NCT03975790|182864374|SUPERIORITY|||||||8.33|||||||Chi-squared|||Asthma||||8.33
91496772|NCT03975790|182864374|SUPERIORITY|||||||0.7483|||||||Chi-squared|||Asthma||||0.7483
91496773|NCT03975790|182864374|SUPERIORITY|||||||0.9713|||||||Chi-squared|||Asthma||||0.9713
91496774|NCT03975790|182864374|SUPERIORITY|||||||0.9148|||||||Chi-squared|||Kidney disease||||0.9148
91496775|NCT03975790|182864374|SUPERIORITY|||||||0.7248|||||||Chi-squared|||Kidney disease||||0.7248
91496776|NCT03975790|182864374|SUPERIORITY|||||||0.82|||||||Chi-squared|||Kidney disease||||0.8200
91496777|NCT03975790|182864374|SUPERIORITY|||||||0.9657|||||||Chi-squared|||Diabetes||||0.9657
91496778|NCT03975790|182864374|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Diabetes||||0.9255
91496779|NCT03975790|182864374|SUPERIORITY|||||||0.9575|||||||Chi-squared|||Diabetes||||0.9575
91496780|NCT03975790|182864374|SUPERIORITY|||||||0.941|||||||Chi-squared|||Depression||||0.9410
91496781|NCT03975790|182864374|SUPERIORITY|||||||0.9146|||||||Chi-squared|||Depression||||0.9146
91496782|NCT03975790|182864374|SUPERIORITY|||||||0.9641|||||||Chi-squared|||Depression||||0.9641
91496783|NCT03975790|182864374|SUPERIORITY|||||||0.2596|||||||Chi-squared|||Anxiety||||0.2596
91496784|NCT03975790|182864374|SUPERIORITY|||||||0.2228|||||||Chi-squared|||Anxiety||||0.2228
91496785|NCT03975790|182864374|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Anxiety||||0.7824
91496786|NCT03975790|182864374|SUPERIORITY|||||||0.4184|||||||Chi-squared|||Liver disease||||0.4184
91496787|NCT03975790|182864374|SUPERIORITY|||||||0.4371|||||||Chi-squared|||Liver disease||||0.4371
91496788|NCT03975790|182864374|SUPERIORITY|||||||0.2074|||||||Chi-squared|||Liver disease||||0.2074
91496789|NCT03975790|182864374|SUPERIORITY|||||||0.785|||||||Chi-squared|||Sleep disorders||||0.7850
91496790|NCT03975790|182864374|SUPERIORITY|||||||0.1288|||||||Chi-squared|||Sleep disorders||||0.1288
91496791|NCT03975790|182864374|SUPERIORITY|||||||0.2839|||||||Chi-squared|||Sleep disorders||||0.2839
91496792|NCT03975790|182864375|SUPERIORITY|||||||0.2242|||||||Chi-squared|||||||0.2242
91496793|NCT03975790|182864375|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
91496794|NCT03975790|182864375|SUPERIORITY|||||||0.0557|||||||Chi-squared|||||||0.0557
91496795|NCT03975790|182864376|SUPERIORITY|||||||0.5944|||||||Chi-squared|||Switch immediately||||0.5944
91496796|NCT03975790|182864376|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Switch immediately||||0.9255
91496797|NCT03975790|182864376|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Switch immediately||||0.7824
91496798|NCT03975790|182864376|SUPERIORITY|||||||0.3975|||||||Chi-squared|||Discontinue then switch||||0.3975
91496799|NCT03975790|182864376|SUPERIORITY|||||||0.0552|||||||Chi-squared|||Discontinue then switch||||0.0552
91496800|NCT03975790|182864376|SUPERIORITY|||||||0.3914|||||||Chi-squared|||Discontinue then switch||||0.3914
91496801|NCT03975790|182864376|SUPERIORITY|||||||0.2036|||||||Chi-squared|||Discontinue then restart||||0.2036
91496802|NCT03975790|182864376|SUPERIORITY|||||||0.1336|||||||Chi-squared|||Discontinue then restart||||0.1336
91496803|NCT03975790|182864376|SUPERIORITY|||||||0.7095|||||||Chi-squared|||Discontinue then restart||||0.7095
91496804|NCT03975790|182864376|SUPERIORITY|||||||0.2241|||||||Chi-squared|||Discontinue without switch or restart||||0.2241
91496805|NCT03975790|182864376|SUPERIORITY|||||||0.0024|||||||Chi-squared|||Discontinue without switch or restart||||0.0024
91496806|NCT03975790|182864376|SUPERIORITY|||||||0.1204|||||||Chi-squared|||Discontinue without switch or restart||||0.1204
91496807|NCT03975790|182864377|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
91496808|NCT03975790|182864377|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
91702816|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.853||||0.4634|TWO_SIDED|95.0|0.558|1.305|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.305|0.558|0.4634
91496809|NCT03975790|182864377|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
91496810|NCT03975790|182864378|SUPERIORITY|||||||0.2036|||||||Chi-squared|||||||0.2036
91496811|NCT03975790|182864378|SUPERIORITY|||||||0.1336|||||||Chi-squared|||||||0.1336
91496812|NCT03975790|182864378|SUPERIORITY|||||||0.7095|||||||Chi-squared|||||||0.7095
91496813|NCT03975790|182864380|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
91496814|NCT03975790|182864380|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
91496815|NCT03975790|182864380|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
91496816|NCT03975790|182864381|SUPERIORITY|||||||0.0309|||||||Chi-squared|||Leflunomide||||0.0309
91496817|NCT03975790|182864381|SUPERIORITY|||||||0.9978|||||||Chi-squared|||Leflunomide||||0.9978
91496818|NCT03975790|182864381|SUPERIORITY|||||||0.2629|||||||Chi-squared|||Leflunomide||||0.2629
91496819|NCT03975790|182864381|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Sulfasalazine||||0.0225
91496820|NCT03975790|182864381|SUPERIORITY|||||||0.4456|||||||Chi-squared|||Sulfasalazine||||0.4456
91496821|NCT03975790|182864381|SUPERIORITY|||||||0.5065|||||||Chi-squared|||Sulfasalazine||||0.5065
91496822|NCT03975790|182864381|SUPERIORITY|||||||0.6617|||||||Chi-squared|||Hydroxychloroquine||||0.6617
91496823|NCT03975790|182864381|SUPERIORITY|||||||0.7309|||||||Chi-squared|||Hydroxychloroquine||||0.7309
91496824|NCT03975790|182864381|SUPERIORITY|||||||0.9861|||||||Chi-squared|||Hydroxychloroquine||||0.9861
91702817|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.655|||<|0.0001|TWO_SIDED|95.0|9.725|39.722|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (Rapid Virological Response \[RVR\] vs No RVR/EVR \[Early Virological Response\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||39.722|9.725|<0.0001
91496825|NCT03975790|182864382|SUPERIORITY|||||||0.088|||||||Chi-squared|||||||0.0880
91496826|NCT03975790|182864382|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91496827|NCT03975790|182864382|SUPERIORITY|||||||0.0065|||||||Chi-squared|||||||0.0065
91496828|NCT03975790|182864383|SUPERIORITY|||||||0.5157|||||||Chi-squared|||||||0.5157
91496829|NCT03975790|182864383|SUPERIORITY|||||||0.1231|||||||Chi-squared|||||||0.1231
91496830|NCT03975790|182864383|SUPERIORITY|||||||0.2109|||||||Chi-squared|||||||0.2109
91496831|NCT03975790|182864384|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
91496832|NCT03975790|182864384|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
91496833|NCT03975790|182864384|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
91496834|NCT03975790|182864385|SUPERIORITY|||||||0.0654|||||||Chi-squared|||||||0.0654
91496835|NCT03975790|182864385|SUPERIORITY|||||||0.7315|||||||Chi-squared|||||||0.7315
91496836|NCT03975790|182864385|SUPERIORITY|||||||0.1897|||||||Chi-squared|||||||0.1897
91496837|NCT03975790|182864386|SUPERIORITY|||||||0.5146|||||||Chi-squared|||||||0.5146
91496838|NCT03975790|182864386|SUPERIORITY|||||||0.7121|||||||Chi-squared|||||||0.7121
91496839|NCT03975790|182864386|SUPERIORITY|||||||0.4434|||||||Chi-squared|||||||0.4434
91496840|NCT03975790|182864387|SUPERIORITY|||||||0.8966|||||||Chi-squared|||||||0.8966
91496841|NCT03975790|182864387|SUPERIORITY|||||||0.2105|||||||Chi-squared|||||||0.2105
91702818|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.569|||<|0.0001|TWO_SIDED|95.0|4.408|16.658|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR \[Complete Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||16.658|4.408|<0.0001
91702819|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.519||||0.0089|TWO_SIDED|95.0|1.26|5.034|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR \[Partial Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.034|1.260|0.0089
91496842|NCT03975790|182864387|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
91496843|NCT03975790|182864389|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.3610
91496844|NCT03975790|182864389|SUPERIORITY|||||||0.4519|||||||Chi-squared|||||||0.4519
91530798|NCT01058863|182937660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.81|1.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..||1.35|0.81|<0.0001
91530799|NCT01058863|182937660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.61|1.15||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.15|0.61|<0.0001
91702820|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.0037|TWO_SIDED|95.0|0.851|0.969|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.969|0.851|0.0037
91535601|NCT00991276|182949769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.65|1.46||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.46|0.65|<0.0001
91702821|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.553||||0.002|TWO_SIDED|95.0|0.379|0.805|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.805|0.379|0.0020
91702822|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.537||||0.0003|TWO_SIDED|95.0|3.654|74.849|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||74.849|3.654|0.0003
91702823|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.386||||0.0733|TWO_SIDED|95.0|0.87|22.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||22.114|0.870|0.0733
91496845|NCT03975790|182864389|SUPERIORITY|||||||0.9612|||||||Chi-squared|||||||0.9612
91496846|NCT03975790|182864390|SUPERIORITY|||||||0.8135|||||||Chi-squared|||||||0.8135
91496847|NCT03975790|182864390|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||0.5910
91496848|NCT03975790|182864390|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
91496849|NCT03975790|182864391|SUPERIORITY|||||||0.597|||||||Chi-squared|||||||0.5970
91496850|NCT03975790|182864391|SUPERIORITY|||||||0.7055|||||||Chi-squared|||||||0.7055
91496851|NCT03975790|182864392|SUPERIORITY|||||||0.5435|||||||Chi-squared|||||||0.5435
91496852|NCT03975790|182864392|SUPERIORITY|||||||0.679|||||||Chi-squared|||||||0.6790
91496853|NCT03975790|182864392|SUPERIORITY|||||||0.9676|||||||Chi-squared|||||||0.9676
91496854|NCT03975790|182864393|SUPERIORITY|||||||0.8035|||||||Chi-squared|||||||0.8035
91496855|NCT03975790|182864393|SUPERIORITY|||||||0.4184|||||||Chi-squared|||||||0.4184
91496856|NCT03975790|182864393|SUPERIORITY|||||||0.395|||||||Chi-squared|||||||0.3950
91496857|NCT03975790|182864395|SUPERIORITY|||||||0.7871|||||||Chi-squared|||||||0.7871
91496858|NCT03975790|182864395|SUPERIORITY|||||||0.0722|||||||Chi-squared|||||||0.0722
91496859|NCT03975790|182864395|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.1810
91496860|NCT03975790|182864396|SUPERIORITY|||||||0.1984|||||||Chi-squared|||||||0.1984
91496861|NCT03975790|182864396|SUPERIORITY|||||||0.2043|||||||Chi-squared|||||||0.2043
91496862|NCT03975790|182864396|SUPERIORITY|||||||0.0439|||||||Chi-squared|||||||0.0439
91496863|NCT03975790|182864397|SUPERIORITY|||||||0.1702|||||||Chi-squared|||||||0.1702
91702824|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.352||||0.3478|TWO_SIDED|95.0|0.394|14.031|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.031|0.394|0.3478
91702825|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.0264|TWO_SIDED|95.0|0.552|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.552|0.0264
91702826|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.658||||0.0096|TWO_SIDED|95.0|1.586|27.946|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||27.946|1.586|0.0096
91702827|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.734||||0.0421|TWO_SIDED|95.0|1.057|21.203|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.203|1.057|0.0421
91702828|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.602||||0.6004|TWO_SIDED|95.0|0.09|4.014|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.014|0.090|0.6004
91702829|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.715||||0.0418|TWO_SIDED|95.0|0.517|0.988|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.988|0.517|0.0418
91702830|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.198||||0.0279|TWO_SIDED|95.0|0.047|0.839|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.839|0.047|0.0279
91702831|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|40.88|||<|0.0001|TWO_SIDED|95.0|7.474|223.61|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||223.61|7.474|<0.0001
91496864|NCT03975790|182864397|SUPERIORITY|||||||0.5926|||||||Chi-squared|||||||0.5926
91702832|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.395|||<|0.0001|TWO_SIDED|95.0|8.724|206.02|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||206.02|8.724|<0.0001
91702833|NCT01066793|183300060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.247||||0.0087|TWO_SIDED|95.0|1.704|39.908|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||39.908|1.704|0.0087
91702834|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957||||0.0002|TWO_SIDED|95.0|1.383|2.77|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.770|1.383|0.0002
91496865|NCT03975790|182864397|SUPERIORITY|||||||0.3088|||||||Chi-squared|||||||0.3088
91496866|NCT03975790|182864398|SUPERIORITY|||||||0.9141|||||||Chi-squared|||||||0.9141
91496867|NCT03975790|182864398|SUPERIORITY|||||||0.7623|||||||Chi-squared|||||||0.7623
91496868|NCT03975790|182864398|SUPERIORITY|||||||0.8517|||||||Chi-squared|||||||0.8517
91496869|NCT03975790|182864399|SUPERIORITY|||||||0.1208|||||||Chi-squared|||||||0.1208
91496870|NCT03975790|182864399|SUPERIORITY|||||||0.0425|||||||Chi-squared|||||||0.0425
91496871|NCT03975790|182864399|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
91496872|NCT03975790|182864400|SUPERIORITY|||||||0.8698|||||||t-test|||||||0.8698
91496873|NCT03975790|182864400|SUPERIORITY|||||||0.7391|||||||t-test|||||||0.7391
91496874|NCT03975790|182864400|SUPERIORITY|||||||0.7043|||||||t-test|||||||0.7043
91496875|NCT03975790|182864401|SUPERIORITY|||||||0.0536|||||||t-test|||||||0.0536
91496876|NCT03975790|182864401|SUPERIORITY|||||||0.9313|||||||t-test|||||||0.9313
91496877|NCT03975790|182864401|SUPERIORITY|||||||0.374|||||||t-test|||||||0.3740
91496878|NCT03975790|182864402|SUPERIORITY|||||||0.6963|||||||t-test|||||||0.6963
91496879|NCT03975790|182864402|SUPERIORITY|||||||0.9816|||||||t-test|||||||0.9816
91496880|NCT03975790|182864402|SUPERIORITY|||||||0.8349|||||||t-test|||||||0.8349
91496881|NCT03975790|182864403|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
91496882|NCT03975790|182864403|SUPERIORITY|||||||0.9431|||||||t-test|||||||0.9431
91702835|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.337||||0.0007|TWO_SIDED|95.0|1.661|6.705|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.705|1.661|0.0007
91702836|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.305||||0.3611|TWO_SIDED|95.0|0.737|2.312|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.312|0.737|0.3611
91702837|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.943|||<|0.0001|TWO_SIDED|95.0|0.929|0.958|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.958|0.929|<0.0001
91702838|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.002|TWO_SIDED|95.0|0.615|0.897|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.897|0.615|0.0020
91702839|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.864||||0.0004|TWO_SIDED|95.0|1.322|2.628|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.628|1.322|0.0004
91702840|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.124||||0.0386|TWO_SIDED|95.0|1.04|4.338|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.338|1.040|0.0386
91702841|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.398||||0.0004|TWO_SIDED|95.0|1.722|6.706|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.706|1.722|0.0004
91702842|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.2769|TWO_SIDED|95.0|0.776|2.428|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.428|0.776|0.2769
91702843|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.945|||<|0.0001|TWO_SIDED|95.0|0.931|0.96|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.960|0.931|<0.0001
91702844|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.163||||0.0001|TWO_SIDED|95.0|1.078|1.256|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.256|1.078|0.0001
91702845|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.788||||0.0213|TWO_SIDED|95.0|1.091|2.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.932|1.091|0.0213
91702846|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0002|TWO_SIDED|95.0|0.856|0.953|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.856|0.0002
91736314|NCT03781479|183365690|OTHER||Mean Difference (Net)|0.792||||0.0083|TWO_SIDED|95.0|0.22|1.37|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments along with a 95% confidence interval for this difference.|A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.||1.37|0.22|0.0083
91736315|NCT01728246|183365691|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91496883|NCT03975790|182864403|SUPERIORITY|||||||0.2964|||||||t-test|||||||0.2964
91496884|NCT03975790|182864404|SUPERIORITY|||||||0.2614|||||||t-test|||||||0.2614
91496885|NCT03975790|182864404|SUPERIORITY|||||||0.0014|||||||t-test|||||||0.0014
91496886|NCT03975790|182864404|SUPERIORITY|||||||0.0535|||||||t-test|||||||0.0535
91702847|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.0306|TWO_SIDED|95.0|0.538|0.97|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.538|0.0306
91702848|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.145||||0.0005|TWO_SIDED|95.0|1.061|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.061|0.0005
91702849|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.0122|TWO_SIDED|95.0|1.151|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.151|0.0122
91702850|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.0956|TWO_SIDED|95.0|0.872|5.424|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.424|0.872|0.0956
91702851|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.267||||0.0846|TWO_SIDED|95.0|0.06|1.197|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.197|0.060|0.0846
91702852|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.897|||<|0.0001|TWO_SIDED|95.0|0.852|0.945|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.945|0.852|<0.0001
91702853|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
91705624|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.46|0.49||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.49|-0.46|0.950
91705625|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.01|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.45|0.48||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.48|-0.45|0.950
91705626|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.23||0.792|TWO_SIDED|95.0|-0.39|0.51||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.39|0.792
91705627|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.11|STANDARD_ERROR_OF_MEAN|0.23||0.631|TWO_SIDED|95.0|-0.34|0.55||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.55|-0.34|0.631
91705628|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.691|TWO_SIDED|95.0|-0.38|0.58||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.58|-0.38|0.691
91705629|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.801|TWO_SIDED|95.0|-0.53|0.41||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.41|-0.53|0.801
91705630|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.93|STANDARD_ERROR_OF_MEAN|0.5||0.065|TWO_SIDED|95.0|-0.06|1.92||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.92|-0.06|0.065
91736316|NCT01728246|183365692|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91736317|NCT01728246|183365694|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91496887|NCT03975790|182864405|SUPERIORITY|||||||0.0051|||||||t-test|||1 months before index date||||0.0051
91496888|NCT03975790|182864405|SUPERIORITY|||||||0.3041|||||||t-test|||1 months before index date||||0.3041
91496889|NCT03975790|182864405|SUPERIORITY|||||||0.4432|||||||t-test|||1 months before index date||||0.4432
91496890|NCT03975790|182864405|SUPERIORITY|||||||0.8641|||||||t-test|||2 months before index date||||0.8641
91496891|NCT03975790|182864405|SUPERIORITY|||||||0.0435|||||||t-test|||2 months before index date||||0.0435
91496892|NCT03975790|182864405|SUPERIORITY|||||||0.153|||||||t-test|||2 months before index date||||0.1530
91496893|NCT03975790|182864405|SUPERIORITY|||||||0.1188|||||||t-test|||3 months before index date||||0.1188
91496894|NCT03975790|182864405|SUPERIORITY|||||||0.6807|||||||t-test|||3 months before index date||||0.6807
91496895|NCT03975790|182864405|SUPERIORITY|||||||0.1772|||||||t-test|||3 months before index date||||0.1772
91496896|NCT03975790|182864405|SUPERIORITY|||||||0.6104|||||||t-test|||4 months before index date||||0.6104
91702854|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
91702855|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
91702856|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
91702857|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
91702858|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
91702859|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
91702860|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
91702861|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
91496897|NCT03975790|182864405|SUPERIORITY|||||||0.9564|||||||t-test|||4 months before index date||||0.9564
91496898|NCT03975790|182864405|SUPERIORITY|||||||0.7688|||||||t-test|||4 months before index date||||0.7688
91496899|NCT03975790|182864405|SUPERIORITY|||||||0.5685|||||||t-test|||5 months before index date||||0.5685
91496900|NCT03975790|182864405|SUPERIORITY|||||||0.5122|||||||t-test|||5 months before index date||||0.5122
91496901|NCT03975790|182864405|SUPERIORITY|||||||0.4321|||||||t-test|||5 months before index date||||0.4321
91496902|NCT03975790|182864405|SUPERIORITY|||||||0.7892|||||||t-test|||6 months before index date||||0.7892
91496903|NCT03975790|182864405|SUPERIORITY|||||||0.2874|||||||t-test|||6 months before index date||||0.2874
91496904|NCT03975790|182864405|SUPERIORITY|||||||0.2662|||||||t-test|||6 months before index date||||0.2662
91496905|NCT03975790|182864405|SUPERIORITY|||||||0.3091|||||||t-test|||7 months before index date||||0.3091
91496906|NCT03975790|182864405|SUPERIORITY|||||||0.5783|||||||t-test|||7 months before index date||||0.5783
91496907|NCT03975790|182864405|SUPERIORITY|||||||0.4021|||||||t-test|||7 months before index date||||0.4021
91496908|NCT03975790|182864405|SUPERIORITY|||||||0.767|||||||t-test|||8 months before index date||||0.7670
91496909|NCT03975790|182864405|SUPERIORITY|||||||0.6978|||||||t-test|||8 months before index date||||0.6978
91496910|NCT03975790|182864405|SUPERIORITY|||||||0.6328|||||||t-test|||8 months before index date||||0.6328
91496911|NCT03975790|182864405|SUPERIORITY|||||||0.0541|||||||t-test|||9 months before index date||||0.0541
91496912|NCT03975790|182864405|SUPERIORITY|||||||0.6999|||||||t-test|||9 months before index date||||0.6999
91702862|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
91702863|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.266||||0.0182|TWO_SIDED|95.0|1.041|1.541|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.541|1.041|0.0182
91702864|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.0092|TWO_SIDED|95.0|1.122|2.254|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.254|1.122|0.0092
91702865|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.974||||0.002|TWO_SIDED|95.0|1.488|5.942|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.942|1.488|0.0020
91702866|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.142||||0.6524|TWO_SIDED|95.0|0.641|2.035|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.035|0.641|0.6524
91702867|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.108|||<|0.0001|TWO_SIDED|95.0|0.037|0.311|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.311|0.037|<0.0001
91702868|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.389||||0.0429|TWO_SIDED|95.0|0.156|0.97|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.156|0.0429
91702869|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.549|TWO_SIDED|95.0|0.523|3.38|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.380|0.523|0.5490
91702870|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.0008|TWO_SIDED|95.0|1.054|1.224|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.224|1.054|0.0008
91496913|NCT03975790|182864405|SUPERIORITY|||||||0.359|||||||t-test|||9 months before index date||||0.3590
91496914|NCT03975790|182864405|SUPERIORITY|||||||0.936|||||||t-test|||10 months before index date||||0.9360
91496915|NCT03975790|182864405|SUPERIORITY|||||||0.626|||||||t-test|||10 months before index date||||0.6260
91702871|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.014|TWO_SIDED|95.0|1.133|3.037|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.037|1.133|0.0140
91702872|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.126||||0.0575|TWO_SIDED|95.0|0.015|1.068|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.068|0.015|0.0575
91702873|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.7128|TWO_SIDED|95.0|0.072|6.025|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.025|0.072|0.7128
91496916|NCT03975790|182864405|SUPERIORITY|||||||0.7797|||||||t-test|||10 months before index date||||0.7797
91496917|NCT03975790|182864405|SUPERIORITY|||||||0.0934|||||||t-test|||11 months before index date||||0.0934
91496918|NCT03975790|182864405|SUPERIORITY|||||||0.396|||||||t-test|||11 months before index date||||0.3960
91496919|NCT03975790|182864405|SUPERIORITY|||||||0.4292|||||||t-test|||11 months before index date||||0.4292
91496920|NCT03975790|182864405|SUPERIORITY|||||||0.854|||||||t-test|||12 months before index date||||0.8540
91496921|NCT03975790|182864405|SUPERIORITY|||||||0.96|||||||t-test|||12 months before index date||||0.9600
91496922|NCT03975790|182864405|SUPERIORITY|||||||0.9374|||||||t-test|||12 months before index date||||0.9374
91496923|NCT03975790|182864405|SUPERIORITY|||||||0.6674|||||||t-test|||1 month after index date||||0.6674
91496924|NCT03975790|182864405|SUPERIORITY|||||||0.0776|||||||t-test|||1 month after index date||||0.0776
91496925|NCT03975790|182864405|SUPERIORITY|||||||0.335|||||||t-test|||1 month after index date||||0.3350
91496926|NCT03975790|182864405|SUPERIORITY|||||||0.8461|||||||t-test|||2 month after index date||||0.8461
91496927|NCT03975790|182864405|SUPERIORITY|||||||0.8111|||||||t-test|||2 month after index date||||0.8111
91496928|NCT03975790|182864405|SUPERIORITY|||||||0.7267|||||||t-test|||2 month after index date||||0.7267
91496929|NCT03975790|182864405|SUPERIORITY|||||||0.2453|||||||t-test|||3 month after index date||||0.2453
91496930|NCT03975790|182864405|SUPERIORITY|||||||0.5889|||||||t-test|||3 month after index date||||0.5889
91496931|NCT03975790|182864405|SUPERIORITY|||||||0.4162|||||||t-test|||3 month after index date||||0.4162
91496932|NCT03975790|182864405|SUPERIORITY|||||||0.0307|||||||t-test|||4 month after index date||||0.0307
91496933|NCT03975790|182864405|SUPERIORITY|||||||0.1147|||||||t-test|||4 month after index date||||0.1147
91496934|NCT03975790|182864405|SUPERIORITY|||||||0.9481|||||||t-test|||4 month after index date||||0.9481
91496935|NCT03975790|182864405|SUPERIORITY|||||||0.4455|||||||t-test|||5 month after index date||||0.4455
91496936|NCT03975790|182864405|SUPERIORITY|||||||0.9445|||||||t-test|||5 month after index date||||0.9445
91496937|NCT03975790|182864405|SUPERIORITY|||||||0.6191|||||||t-test|||5 month after index date||||0.6191
91496938|NCT03975790|182864405|SUPERIORITY|||||||0.0805|||||||t-test|||6 month after index date||||0.0805
91496939|NCT03975790|182864405|SUPERIORITY|||||||0.7037|||||||t-test|||6 month after index date||||0.7037
91496940|NCT03975790|182864405|SUPERIORITY|||||||0.4288|||||||t-test|||6 month after index date||||0.4288
91496941|NCT03975790|182864405|SUPERIORITY|||||||0.3731|||||||t-test|||7 month after index date||||0.3731
91496942|NCT03975790|182864405|SUPERIORITY|||||||0.4803|||||||t-test|||7 month after index date||||0.4803
91496943|NCT03975790|182864405|SUPERIORITY|||||||0.5831|||||||t-test|||7 month after index date||||0.5831
91496944|NCT03975790|182864405|SUPERIORITY|||||||0.0944|||||||t-test|||8 month after index date||||0.0944
91496945|NCT03975790|182864405|SUPERIORITY|||||||0.88|||||||t-test|||8 month after index date||||0.8800
91496946|NCT03975790|182864405|SUPERIORITY|||||||0.4949|||||||t-test|||8 month after index date||||0.4949
91496947|NCT03975790|182864405|SUPERIORITY|||||||0.6373|||||||t-test|||9 month after index date||||0.6373
91496948|NCT03975790|182864405|SUPERIORITY|||||||0.0497|||||||t-test|||9 month after index date||||0.0497
91496949|NCT03975790|182864405|SUPERIORITY|||||||0.1695|||||||t-test|||9 month after index date||||0.1695
91496950|NCT03975790|182864405|SUPERIORITY|||||||0.6373|||||||t-test|||10 month after index date||||0.6373
91496951|NCT03975790|182864405|SUPERIORITY|||||||0.7866|||||||t-test|||10 month after index date||||0.7866
91496952|NCT03975790|182864405|SUPERIORITY|||||||0.7643|||||||t-test|||10 months after index date||||0.7643
91496953|NCT03975790|182864405|SUPERIORITY|||||||0.2307|||||||t-test|||11 month after index date||||0.2307
91496954|NCT03975790|182864405|SUPERIORITY|||||||0.6712|||||||t-test|||11 month after index date||||0.6712
91496955|NCT03975790|182864405|SUPERIORITY|||||||0.6953|||||||t-test|||11 months after index date||||0.6953
91496956|NCT03975790|182864405|SUPERIORITY|||||||0.3675|||||||t-test|||12 month after index date||||0.3675
91496957|NCT03975790|182864405|SUPERIORITY|||||||0.8027|||||||t-test|||12 month after index date||||0.8027
91496958|NCT03975790|182864405|SUPERIORITY|||||||0.4817|||||||t-test|||12 month after index date||||0.4817
91496959|NCT03975790|182864406|SUPERIORITY|||||||0.0063|||||||t-test|||1 month before index date||||0.0063
91496960|NCT03975790|182864406|SUPERIORITY|||||||0.0162|||||||t-test|||1 month before index date||||0.0162
91496961|NCT03975790|182864406|SUPERIORITY|||||||0.8715|||||||t-test|||1 month before index date||||0.8715
91496962|NCT03975790|182864406|SUPERIORITY|||||||0.2799|||||||t-test|||2 months before index date||||0.2799
91496963|NCT03975790|182864406|SUPERIORITY|||||||0.0126|||||||t-test|||2 months before index date||||0.0126
91496964|NCT03975790|182864406|SUPERIORITY|||||||0.2126|||||||t-test|||2 months before index date||||0.2126
91496965|NCT03975790|182864406|SUPERIORITY|||||||0.7004|||||||t-test|||3 months before index date||||0.7004
91496966|NCT03975790|182864406|SUPERIORITY|||||||0.1476|||||||t-test|||3 months before index date||||0.1476
91496967|NCT03975790|182864406|SUPERIORITY|||||||0.2057|||||||t-test|||3 months before index date||||0.2057
91496968|NCT03975790|182864406|SUPERIORITY|||||||0.2905|||||||t-test|||4 months before index date||||0.2905
91496969|NCT03975790|182864406|SUPERIORITY|||||||0.8273|||||||t-test|||4 months before index date||||0.8273
91496970|NCT03975790|182864406|SUPERIORITY|||||||0.627|||||||t-test|||4 months before index date||||0.6270
91496971|NCT03975790|182864406|SUPERIORITY|||||||0.3256|||||||t-test|||5 months before index date||||0.3256
91496972|NCT03975790|182864406|SUPERIORITY|||||||0.5631|||||||t-test|||5 months before index date||||0.5631
91496973|NCT03975790|182864406|SUPERIORITY|||||||0.4491|||||||t-test|||5 months before index date||||0.4491
91496974|NCT03975790|182864406|SUPERIORITY|||||||0.2009|||||||t-test|||6 months before index date||||0.2009
91496975|NCT03975790|182864406|SUPERIORITY|||||||0.3011|||||||t-test|||6 months before index date||||0.3011
91496976|NCT03975790|182864406|SUPERIORITY|||||||0.2065|||||||t-test|||6 months before index date||||0.2065
91496977|NCT03975790|182864406|SUPERIORITY|||||||0.6098|||||||t-test|||7 months before index date||||0.6098
91496978|NCT03975790|182864406|SUPERIORITY|||||||0.2586|||||||t-test|||7 months before index date||||0.2586
91702874|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.596|TWO_SIDED|95.0|0.04|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.040|0.5960
91702875|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.051||||0.0033|TWO_SIDED|95.0|1.27|3.311|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.311|1.270|0.0033
91702876|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.113||||0.0452|TWO_SIDED|95.0|1.002|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.002|0.0452
91702877|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||0.004|TWO_SIDED|95.0|0.043|0.551|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.551|0.043|0.0040
91702878|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.393||||0.0833|TWO_SIDED|95.0|0.137|1.131|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||1.131|0.137|0.0833
91702879|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.1439|TWO_SIDED|95.0|0.01|1.951|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.951|0.010|0.1439
91702880|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.4457|TWO_SIDED|95.0|0.024|5.194|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.194|0.024|0.4457
91702881|NCT01066793|183300074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.142||||0.6258|TWO_SIDED|95.0|0.1|45.801|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||45.801|0.100|0.6258
91702882|NCT02607280|183300095|OTHER||LS mean change from baseline at Week 14|-1.79|||||TWO_SIDED|95.0|-2.45|-1.14||||||||-1.14|-2.45|
91702883|NCT02607280|183300095|OTHER||LS mean change from baseline at Week 14|-2.07|||||TWO_SIDED|95.0|-3.77|-0.36||||||||-0.36|-3.77|
91702884|NCT02052596|183300111|NON_INFERIORITY|Criteria for non-inferiority: At one month after the last vaccine dose (Month 3 or Month 5), the upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies GMC ratio between the Control Group and the GSK1437173A Group had to be below (\<) 1.5,|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.02|1.21||||Adjustment for baseline concentration and age - pooled variance.||Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.||1.21|1.02|
91702885|NCT02052596|183300112|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PT antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.17|||||TWO_SIDED|95.0|1.0|1.36||||Ancova model: adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.||1.36|1.00|
91702886|NCT02052596|183300112|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-FHA antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|1.07|1.44||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.||1.44|1.07|
91705631|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.274|TWO_SIDED|95.0|-0.43|1.51||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.51|-0.43|0.274
91496979|NCT03975790|182864406|SUPERIORITY|||||||0.4074|||||||t-test|||7 months before index date||||0.4074
91496980|NCT03975790|182864406|SUPERIORITY|||||||0.0345|||||||t-test|||8 months before index date||||0.0345
91496981|NCT03975790|182864406|SUPERIORITY|||||||0.4377|||||||t-test|||8 months before index date||||0.4377
91496982|NCT03975790|182864406|SUPERIORITY|||||||0.7191|||||||t-test|||8 months before index date||||0.7191
91496983|NCT03975790|182864406|SUPERIORITY|||||||0.0199|||||||t-test|||9 months before index date||||0.0199
91496984|NCT03975790|182864406|SUPERIORITY|||||||0.1032|||||||t-test|||9 months before index date||||0.1032
91496985|NCT03975790|182864406|SUPERIORITY|||||||0.904|||||||t-test|||9 months before index date||||0.9040
91496986|NCT03975790|182864406|SUPERIORITY|||||||0.0316|||||||t-test|||10 months before index date||||0.0316
91496987|NCT03975790|182864406|SUPERIORITY|||||||0.6748|||||||t-test|||10 months before index date||||0.6748
91496988|NCT03975790|182864406|SUPERIORITY|||||||0.2679|||||||t-test|||10 months before index date||||0.2679
91496989|NCT03975790|182864406|SUPERIORITY|||||||0.501|||||||t-test|||11 months before index date||||0.5010
91496990|NCT03975790|182864406|SUPERIORITY|||||||0.3228|||||||t-test|||11 months before index date||||0.3228
91496991|NCT03975790|182864406|SUPERIORITY|||||||0.7881|||||||t-test|||11 months before index date||||0.7881
91496992|NCT03975790|182864406|SUPERIORITY|||||||0.0876|||||||t-test|||12 months before index date||||0.0876
91702887|NCT02052596|183300112|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PRN antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.27|||||TWO_SIDED|95.0|1.02|1.58||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.||1.58|1.02|
91702888|NCT02052596|183300113|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-diphtheria (anti-D) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|-0.1|||||TWO_SIDED|95.0|-3.03|2.85||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.||2.85|-3.03|
91496993|NCT03975790|182864406|SUPERIORITY|||||||0.1226|||||||t-test|||12 months before index date||||0.1226
91496994|NCT03975790|182864406|SUPERIORITY|||||||0.9753|||||||t-test|||12 months before index date||||0.9753
91496995|NCT03975790|182864406|SUPERIORITY|||||||0.0336|||||||t-test|||1 month after index date||||0.0336
91496996|NCT03975790|182864406|SUPERIORITY|||||||0.2551|||||||t-test|||1 month after index date||||0.2551
91496997|NCT03975790|182864406|SUPERIORITY|||||||0.6189|||||||t-test|||1 month after index date||||0.6189
91496998|NCT03975790|182864406|SUPERIORITY|||||||0.7051|||||||t-test|||2 months after index date||||0.7051
91496999|NCT03975790|182864406|SUPERIORITY|||||||0.9775|||||||t-test|||2 months after index date||||0.9775
91497000|NCT03975790|182864406|SUPERIORITY|||||||0.7643|||||||t-test|||2 months after index date||||0.7643
91497001|NCT03975790|182864406|SUPERIORITY|||||||0.2953|||||||t-test|||3 months after index date||||0.2953
91497002|NCT03975790|182864406|SUPERIORITY|||||||0.6257|||||||t-test|||3 months after index date||||0.6257
91497003|NCT03975790|182864406|SUPERIORITY|||||||0.4753|||||||t-test|||3 months after index date||||0.4753
91497004|NCT03975790|182864406|SUPERIORITY|||||||0.0926|||||||t-test|||4 months after index date||||0.0926
91497005|NCT03975790|182864406|SUPERIORITY|||||||0.0013|||||||t-test|||4 months after index date||||0.0013
91497006|NCT03975790|182864406|SUPERIORITY|||||||0.0065|||||||t-test|||4 months after index date||||0.0065
91497007|NCT03975790|182864406|SUPERIORITY|||||||0.2212|||||||t-test|||5 months after index date||||0.2212
91497008|NCT03975790|182864406|SUPERIORITY|||||||0.9688|||||||t-test|||5 months after index date||||0.9688
91497009|NCT03975790|182864406|SUPERIORITY|||||||0.5647|||||||t-test|||5 months after index date||||0.5647
91497010|NCT03975790|182864406|SUPERIORITY|||||||0.0023|||||||t-test|||6 months after index date||||0.0023
91497011|NCT03975790|182864406|SUPERIORITY|||||||0.1142|||||||t-test|||6 months after index date||||0.1142
91497012|NCT03975790|182864406|SUPERIORITY|||||||0.3842|||||||t-test|||6 months after index date||||0.3842
91497013|NCT03975790|182864406|SUPERIORITY|||||||0.9097|||||||t-test|||7 months after index date||||0.9097
91497014|NCT03975790|182864406|SUPERIORITY|||||||0.3885|||||||t-test|||7 months after index date||||0.3885
91497015|NCT03975790|182864406|SUPERIORITY|||||||0.3834|||||||t-test|||7 months after index date||||0.3834
91497016|NCT03975790|182864406|SUPERIORITY|||||||0.3075|||||||t-test|||8 months after index date||||0.3075
91497017|NCT03975790|182864406|SUPERIORITY|||||||0.9075|||||||t-test|||8 months after index date||||0.9075
91497018|NCT03975790|182864406|SUPERIORITY|||||||0.5993|||||||t-test|||8 months after index date||||0.5993
91497019|NCT03975790|182864406|SUPERIORITY|||||||0.0775|||||||t-test|||9 months after index date||||0.0775
91497020|NCT03975790|182864406|SUPERIORITY|||||||0.1536|||||||t-test|||9 months after index date||||0.1536
91497021|NCT03975790|182864406|SUPERIORITY|||||||0.8553|||||||t-test|||9 months after index date||||0.8553
91497022|NCT03975790|182864406|SUPERIORITY|||||||0.6295|||||||t-test|||10 months after index date||||0.6295
91497023|NCT03975790|182864406|SUPERIORITY|||||||0.0551|||||||t-test|||10 months after index date||||0.0551
91497024|NCT03975790|182864406|SUPERIORITY|||||||0.2215|||||||t-test|||10 months after index date||||0.2215
91497025|NCT03975790|182864406|SUPERIORITY|||||||0.1948|||||||t-test|||11 months after index date||||0.1948
91497026|NCT03975790|182864406|SUPERIORITY|||||||0.6621|||||||t-test|||11 months after index date||||0.6621
91497027|NCT03975790|182864406|SUPERIORITY|||||||0.6629|||||||t-test|||11 months after index date||||0.6629
91497028|NCT03975790|182864406|SUPERIORITY|||||||0.5699|||||||t-test|||12 months after index date||||0.5699
91497029|NCT03975790|182864406|SUPERIORITY|||||||0.7105|||||||t-test|||12 months after index date||||0.7105
91497030|NCT03975790|182864406|SUPERIORITY|||||||0.5965|||||||t-test|||12 months after index date||||0.5965
91497031|NCT03232801|182864407|SUPERIORITY||chi-squared|4.86||||0.027|TWO_SIDED||||||Chi-squared|||||||0.027
91497032|NCT03232801|182864408|SUPERIORITY||chi-squared|0.45||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
91497033|NCT01111149|182864478|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Cotinine at Week 12||||>0.05
91497034|NCT01111149|182864478|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Nicotine at Week 12||||>0.05
91702889|NCT02052596|183300113|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-tetanus (anti-T) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|0.01|||||TWO_SIDED|95.0|-1.18|1.27||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.||1.27|-1.18|
91702890|NCT04526574|183300159|NON_INFERIORITY|Noninferiority (NI) for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|Geometric Mean Ratio (GMR)|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 1: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of least square (LS) means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.65|
91702891|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.75|0.9||||||Serotype 3: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.75|
91702892|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 4: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.02|0.77|
91702893|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||Serotype 5: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.79|
91702894|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 6A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.88|0.65|
91702895|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 6B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.94|0.71|
91702896|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.83|0.99||||||Serotype 7F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.99|0.83|
91702897|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.8|||||TWO_SIDED|95.0|0.7|0.93||||||Serotype 8: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.93|0.70|
91705632|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.48|STANDARD_ERROR_OF_MEAN|0.53||0.359|TWO_SIDED|95.0|-0.55|1.52||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.52|-0.55|0.359
91497035|NCT01111149|182864478|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Cotinine at Week 12||||>0.05
91497036|NCT01111149|182864478|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Nicotine at Week 12||||>0.05
91497037|NCT01111149|182864479|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)||||>0.05
91497038|NCT01111149|182864479|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)||||>0.05
91497039|NCT01111149|182864479|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)||||>0.05
91530800|NCT01058863|182937661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.47|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|26.21|40.74||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.74|26.21|<0.0001
91702898|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.94|||||TWO_SIDED|95.0|0.82|1.07||||||Serotype 9V: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.07|0.82|
91702899|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.83|||||TWO_SIDED|95.0|0.71|0.96||||||Serotype 10A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.71|
91702900|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.71|||||TWO_SIDED|95.0|0.6|0.84||||||Serotype 11A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.60|
91702901|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.69|0.97||||||Serotype 12F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.97|0.69|
91702902|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.86|||||TWO_SIDED|95.0|0.76|0.96||||||Serotype 14: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.76|
91702903|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.7|||||TWO_SIDED|95.0|0.57|0.86||||||Serotype 15B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.86|0.57|
91702904|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.77|1.04||||||Serotype 18C: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.04|0.77|
91702905|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.78|0.98||||||Serotype 19A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.78|
91705633|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.52||0.863|TWO_SIDED|95.0|-0.93|1.11||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.11|-0.93|0.863
91497040|NCT01111149|182864479|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)||||>0.05
91497041|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Composite (Week 12)||||>0.05
91497042|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Global (Week 12)||||>0.05
91497043|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Affective Flattening (Week 12)||||>0.05
91497044|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Alogia (Week 12)||||>0.05
91497045|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Avolition (Week 12)||||>0.05
91497046|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Anhedonia (Week 12)||||>0.05
91497047|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Attention (Week 12)||||>0.05
91497048|NCT01111149|182864480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Inappropriate Affect at Week 12||||>0.05
91497049|NCT01111149|182864481|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT % Omissions (Week 12)||||>0.05
91497050|NCT01111149|182864481|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT% commissions (Week 12)||||>0.05
91702906|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.78|1.01||||||Serotype 19F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.01|0.78|
91702907|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.75|||||TWO_SIDED|95.0|0.62|0.9||||||Serotype 22F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.62|
91702908|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 23F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.92|0.66|
91705634|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.56|STANDARD_ERROR_OF_MEAN|0.56||0.314|TWO_SIDED|95.0|-0.53|1.66||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.66|-0.53|0.314
91497051|NCT01111149|182864481|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for perseveration % (week 12)||||>0.05
91497052|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Anxiety at week 12||||>0.05
91497053|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dizziness at week 12||||>0.05
91497054|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Mania at week 12||||>0.05
91497055|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for abnormal dreams at week 12||||>0.05
91497056|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Abdominal Pain at week 12||||>0.05
91497057|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Headache at week 12||||>0.05
91497058|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Insomnia at week 12||||>0.05
91497059|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Nausea at week 12||||>0.05
91497060|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Psychosis at week 12||||>0.05
91497061|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dry Mouth at week 12||||>0.05
91497062|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Chest Pain at Week 12||||>0.05
91497063|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irregular Heart Beat at week 12||||>0.05
91497064|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Weakness/Fainting at week 12||||>0.05
91497065|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Diarrhea at week 12||||>0.05
91497066|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Vomiting at week 12||||>0.05
91497067|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Constipation at week 12||||>0.05
91497068|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Confusion at week 12||||>0.05
91497069|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irritability at week 12||||>0.05
91497070|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for drooling at week 12||||>0.05
91497071|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Cold Sweats at week 12||||>0.05
91497072|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Blurred Vision at week 12||||>0.05
91497073|NCT01111149|182864482|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Leg Pain/Cramps||||>0.05
91497074|NCT01111149|182864483|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for FTND (Week 12)||||>0.05
91497075|NCT01111149|182864483|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 24 Hour Total (Week 12)||||>0.05
91497076|NCT01111149|182864483|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 7 day total (Week 12)||||>0.05
91497077|NCT01111149|182864483|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS Resistance (Week 12)||||>0.05
91497078|NCT01111149|182864484|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Beck Depression Inventory (Week 12)||||>0.05
91497079|NCT01111149|182864485|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAS (Week 12)||||>0.05
91497080|NCT01111149|182864485|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS items 1-3 (week 12)||||>0.05
91497081|NCT01111149|182864485|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS item 4 (Week 12)||||>0.05
91497082|NCT01111149|182864486|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for systolic blood pressure (Week 12)||||>0.05
91497083|NCT01111149|182864486|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for diastolic blood pressure (Week 12)||||>0.05
91702909|NCT04526574|183300159|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 33F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.83|0.62|
91497084|NCT01111149|182864487|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Weight (Week 12)||||>0.05
91497085|NCT01111149|182864488|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)||||>0.05
91497086|NCT01111149|182864489|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)||||>0.05
91736318|NCT03189719|183365723|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.43|0.75|||Stratified Log-Rank|||OS in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.75|0.43|<0.0001
91497087|NCT01111149|182864490|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Pulse (Week 12)||||>0.05
91497088|NCT01111149|182864491|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicidal Ideation (Week 12)||||>0.05
91497089|NCT01111149|182864491|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicide Attempts (Week 12)||||>0.05
91497090|NCT01111149|182864492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Composite Score - Week 12||||>0.05
91497091|NCT01111149|182864492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Global - Week 12||||>0.05
91497092|NCT01111149|182864492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Hallucinations - Week 12||||>0.05
91497093|NCT01111149|182864492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Delusions - Week 12||||>0.05
91497094|NCT01111149|182864492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for SAPS Bizarre Behavior - Week 12||||>0.05
91497095|NCT01111149|182864492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Thought Disorder - Week 12||||>0.05
91497096|NCT01111149|182864493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Total - Week 12||||>0.05
91497097|NCT01111149|182864493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Positive Subscale - Week 12||||>0.05
91497098|NCT01111149|182864493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Negative Subscale - Week 12||||>0.05
91497099|NCT01111149|182864493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Mania Subscale - Week 12||||>0.05
91497100|NCT01111149|182864493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Disorientation Subscale - Week 12||||>0.05
91497101|NCT01111149|182864493|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Depression Subscale - Week 12||||>0.05
91497102|NCT01111149|182864494|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Hit Reaction Time - CPT (Week 12)||||>0.05
91497103|NCT01111149|182864495|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Variability of Standard Error - CPT (Week 12)||||>0.05
91497104|NCT01111149|182864496|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)||||>0.05
91497105|NCT01111149|182864497|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)||||>0.05
91497106|NCT01111149|182864498|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Total (Week 12)||||>0.05
91497107|NCT01111149|182864498|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for WISDM Cognition (Week 12)||||>0.05
91497108|NCT01111149|182864498|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Craving (Week 12)||||>0.05
91497109|NCT01111149|182864499|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Urge to Smoke (Week 12)||||>0.05
91497110|NCT01111149|182864499|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Strong Urge (Week 12)||||>0.05
91497111|NCT01111149|182864500|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Total (Week 12)||||>0.05
91497112|NCT01111149|182864500|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Severity Index (Week 12)||||>0.05
91497113|NCT01111149|182864500|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for AIMS Global Score (Week 12)||||>0.05
91497114|NCT02221947|182864504|OTHER||mean Tmax(h)|0.92|||||TWO_SIDED||||||||SD=0.206|Bryostatin plasma concentration: mean Tmax (h)||||
91497115|NCT02221947|182864504|OTHER||mean (h*ng/mL)|1.05|||||TWO_SIDED||||||||SD=0.330|Bryostatin plasma concentration AUC0-last (h\*ng/mL)||||
91497116|NCT01574326|182864518|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.9||||0.001|TWO_SIDED|95.0|-1.44|-0.37|||ANCOVA|Threshold for significance ≤ 0.05.||Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.||-0.37|-1.44|0.001
91497117|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.01||||90.0|-0.041|-0.007|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.041|
91497118|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.04|-0.003|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.003|-0.040|
91497119|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.038|0.001|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.001|-0.038|
91497120|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.058|-0.019|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.058|
91497121|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.065|-0.02|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.065|
91702910|NCT04526574|183300160|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.07|||||TWO_SIDED|95.0|0.97|1.17||||||A/H1N1: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.17|0.97|
91736319|NCT03189719|183365724|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0006|TWO_SIDED|95.0|0.6|0.88|||Stratified Log-Rank|||OS in ESCC participants of the pembrolizumab + SOC arm was compared to OS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.88|0.60|0.0006
91497122|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.043|0.002|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.043|
91497123|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.066|-0.02|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.066|
91702911|NCT04526574|183300160|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.98|||||TWO_SIDED|95.0|0.89|1.08||||||A/H3N2: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.89|
91702912|NCT04526574|183300160|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.0|||||TWO_SIDED|95.0|0.93|1.08||||||B/Victoria: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.93|
91497124|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.058|-0.009|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.009|-0.058|
91497125|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.039|0.009|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.009|-0.039|
91497126|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.027|0.017|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.017|-0.027|
91497127|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.037|0.012|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.012|-0.037|
91497128|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.014|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.014|-0.076|
91497129|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.013|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.013|-0.076|
91535602|NCT00991276|182949769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9403|TWO_SIDED|95.0|-0.42|0.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.39|-0.42|0.9403
91702913|NCT04526574|183300160|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.87|1.03||||||B/Phuket: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.03|0.87|
91702914|NCT01032070|183300164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||The study was not powered for this comparison due to small sample size.||||0.2200
91702915|NCT01541839|183300186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|327.0|STANDARD_DEVIATION|70.0|<|0.0001|TWO_SIDED|95.0|||||t-test, 1 sided||The mean time for closure with septal stapler was 35 +/-22 seconds versus 7 minutes +/- 1 minute 10 seconds for suture closure. The mean net difference between groups was 327 seconds, or 6 minutes 27 seconds.|The operative time required for closure and NOSE questionnaire scores were analyzed with unpaired and paired t-tests respectively. Chi-squared testing was used for post-operative complication rates. The mean closure time for septoplasty was estimated to be 10 minutes +/- 4 minutes. It was assumed that the septal stapler would take 5 minutes +/- 4 minutes. Assuming a one-sided test, an alpha of 0.05 and a power of 0.8, a total of 16 patients were needed.||||<0.0001
91702916|NCT01075399|183300193|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.883|||<|0.001|TWO_SIDED|90.0|0.802|0.929||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV max:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV max of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.929|0.802|<0.001
91702917|NCT01075399|183300193|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.887|||<|0.001|TWO_SIDED|90.0|0.792|0.925||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV mean:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV mean of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.925|0.792|<0.001
91497130|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.008|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.071|
91702918|NCT01075399|183300193|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.945|||<|0.001|TWO_SIDED|90.0|0.904|0.967||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor to background SUV ratio:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing tumor to background SUV ratio (T/B) of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in T/B values, and for establishing reproducibility within ±20% or ±25%."||0.967|0.904|<0.001
91702919|NCT01393132|183300195|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||t-test, 2 sided|||Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0108
91702920|NCT01393132|183300196|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED||||||t-test, 2 sided|||Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups||||0.0141
91702921|NCT01393132|183300197|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||t-test, 2 sided|||Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.||||0.0162
91702922|NCT00396877|183300198|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|11.1||||0.434|TWO_SIDED|95.0|-19.2|33.6||The a-priori threshold for statistical significance was \< 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.|Log Rank|A two-sided log-rank test was used.|The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.|"Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.~The study was designed with 80% power and an overall type I error rate of 5%."||33.6|-19.2|0.4340
91702923|NCT00334802|183300201|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for Dose Level 1 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.169
91497131|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.074|-0.008|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.074|
91497132|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.088|-0.025|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.025|-0.088|
91497133|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.007|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.071|
91497134|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.021||||90.0|-0.079|-0.01|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.079|
91497135|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.055|0.016|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.016|-0.055|
91497136|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.079|-0.004|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.079|
91497137|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.091|-0.019|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.091|
91497138|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.081|-0.01|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.081|
91497139|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.073|0.002|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.073|
91702924|NCT00334802|183300201|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Dose Level 2 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.001
91497140|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.121|-0.038|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.038|-0.121|
91497141|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.038||||90.0|-0.124|0.003|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.003|-0.124|
91497142|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.098|-0.033|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.033|-0.098|
91497143|NCT00137046|182864521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.004|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.085|
91497144|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.055||||90.0|-0.06|0.122|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.122|-0.060|
91497145|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.062||||90.0|0.033|0.239|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.239|0.033|
91705635|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.54||0.91|TWO_SIDED|95.0|-1.13|1.01||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.01|-1.13|0.910
91705636|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.19|STANDARD_ERROR_OF_MEAN|0.3||0.532|TWO_SIDED|95.0|-0.4|0.78||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.78|-0.40|0.532
91497146|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.068||||90.0|0.0|0.224|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.000|
91497147|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.257|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.141|0.374|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.374|0.141|
91497148|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.04|0.273|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.273|0.040|
91497149|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.072||||90.0|0.065|0.3|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.300|0.065|
91497150|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.078||||90.0|0.06|0.319|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.319|0.060|
91497151|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|STANDARD_ERROR_OF_MEAN|0.077||||90.0|0.19|0.443|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.443|0.190|
91497152|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.079||||90.0|-0.037|0.224|||ANCOVA|||Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.037|
91497153|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.103|0.145|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.145|-0.103|
91497154|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.082||||90.0|-0.023|0.248|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.248|-0.023|
91497155|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.273|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.126|0.419|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.419|0.126|
91497156|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.087||||90.0|0.219|0.507|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.507|0.219|
91497157|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.128|0.428|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.428|0.128|
91497158|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.144|0.442|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.442|0.144|
91497159|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.094||||90.0|0.058|0.369|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.369|0.058|
91497160|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.086||||90.0|0.101|0.386|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.386|0.101|
91497161|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.09||||90.0|0.079|0.376|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.376|0.079|
91497162|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.079|0.372|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.372|0.079|
91497163|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.095||||90.0|0.055|0.368|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.368|0.055|
91497164|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.092||||90.0|0.18|0.483|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.483|0.180|
91497165|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.097||||90.0|0.302|0.622|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.622|0.302|
91497166|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.115||||90.0|0.221|0.6|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.600|0.221|
91497167|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|STANDARD_ERROR_OF_MEAN|0.161||||90.0|0.183|0.718|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.718|0.183|
91497168|NCT00137046|182864523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.174|0.237|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.237|-0.174|
91497169|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|STANDARD_ERROR_OF_MEAN|6.33||||90.0|-25.24|-4.39|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.39|-25.24|
91497170|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.83|STANDARD_ERROR_OF_MEAN|6.27||||90.0|-35.16|-14.51|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.51|-35.16|
91497171|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|STANDARD_ERROR_OF_MEAN|6.92||||90.0|-37.56|-14.75|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.75|-37.56|
91497172|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.46|STANDARD_ERROR_OF_MEAN|6.74||||90.0|-30.56|-8.36|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-8.36|-30.56|
91497173|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.97|STANDARD_ERROR_OF_MEAN|6.65||||90.0|-50.93|-29.0|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-29.00|-50.93|
91497174|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|STANDARD_ERROR_OF_MEAN|7.02||||90.0|-27.65|-4.51|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.51|-27.65|
91497175|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|6.76||||90.0|-24.69|-2.39|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-2.39|-24.69|
91497176|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.86|STANDARD_ERROR_OF_MEAN|7.29||||90.0|-30.88|-6.84|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-6.84|-30.88|
91497177|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|8.12||||90.0|-9.83|16.96|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||16.96|-9.83|
91497178|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|8.2||||90.0|-31.32|-4.27|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.27|-31.32|
91497179|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|STANDARD_ERROR_OF_MEAN|7.72||||90.0|-33.44|-7.99|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-7.99|-33.44|
91497180|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|7.8||||90.0|-11.06|14.66|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||14.66|-11.06|
91497181|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.72|STANDARD_ERROR_OF_MEAN|9.02||||90.0|-23.61|6.17|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||6.17|-23.61|
91497182|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.34|STANDARD_ERROR_OF_MEAN|7.84||||90.0|-29.28|-3.4|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-3.40|-29.28|
91497183|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.99|STANDARD_ERROR_OF_MEAN|8.25||||90.0|-26.6|0.63|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||0.63|-26.60|
91497184|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|8.58||||90.0|-24.39|3.94|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.94|-24.39|
91497185|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.64|STANDARD_ERROR_OF_MEAN|8.82||||90.0|-43.19|-14.09|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.09|-43.19|
91497186|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|8.91||||90.0|-23.69|5.71|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.71|-23.69|
91497187|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|8.8||||90.0|-24.04|5.0|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.00|-24.04|
91497188|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.67||||90.0|-24.71|3.92|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.92|-24.71|
91497189|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.17|STANDARD_ERROR_OF_MEAN|9.24||||90.0|-21.42|9.09|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||9.09|-21.42|
91497190|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|9.44||||90.0|-20.98|10.21|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||10.21|-20.98|
91497191|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|13.77||||90.0|-38.43|7.26|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||7.26|-38.43|
91497192|NCT00137046|182864526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84|STANDARD_ERROR_OF_MEAN|11.27||||90.0|-15.79|21.46|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||21.46|-15.79|
91497193|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.523|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.846|-0.199|||ANCOVA|||Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.199|-0.846|
91702925|NCT01886781|183300220|NON_INFERIORITY_OR_EQUIVALENCE|To determine an effect size of 0.64 with 80% power, a sample size of 27 for each group (D-IBS, C-IBS and controls), with a type 1 error of 5% using a two sided test was sufficient. Sample size based on expected behaviour of primary outcome measure. The minimally clinically important difference based on the primary outcome measure with the instrument used was 50 points.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) \& time as factors.||||<0.05
91497194|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.113|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-1.541|-0.685|||ANCOVA|||Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.685|-1.541|
91702926|NCT00551161|183300221|SUPERIORITY_OR_OTHER||||||<|0.05||||||Due to the exploratory nature of these analyses, no adjustment for multiple testing was made. Although it would have been preferable to carry out an omnibus analysis, due to the small sample size, the descriptive approach described above was used.|Wilcoxon (Mann-Whitney)|||The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\] for each of the metabolites and ratios, in order to examine whether the rate of change differed while on monotherapy as compared with combination therapy.||||<0.05
91702927|NCT02273908|183300255|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.949|||<|0.001|TWO_SIDED|95.0|-1.459|-0.439|||Mixed Models Analysis|||||-0.439|-1.459|<0.001
91702928|NCT02273908|183300256|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.259|||<|0.001|TWO_SIDED|95.0|-3.131|-1.387|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-1.387|-3.131|<0.001
91702929|NCT02273908|183300256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.887|||<|0.001|TWO_SIDED|95.0|-2.704|-1.071|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-1.071|-2.704|<0.001
91702930|NCT02273908|183300257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3018|||<|0.001|TWO_SIDED|95.0|1.4903|5.1133|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||5.1133|1.4903|<0.001
91702931|NCT02273908|183300257|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|2.729||||0.004|TWO_SIDED|95.0|0.9047|4.5533|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.5533|0.9047|0.004
91497195|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.359|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.836|-0.882|||ANCOVA|||Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.882|-1.836|
91497196|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.184|STANDARD_ERROR_OF_MEAN|0.314||||90.0|-1.702|-0.666|||ANCOVA|||Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.666|-1.702|
91497197|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.338||||90.0|-1.984|-0.869|||ANCOVA|||Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.869|-1.984|
91497198|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.384||||90.0|-2.35|-1.084|||ANCOVA|||Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.084|-2.350|
91702932|NCT02273908|183300258|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.301|-0.359|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-0.359|-1.301|<0.001
91702933|NCT02273908|183300258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.674||||0.004|TWO_SIDED|95.0|-1.125|-0.223|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-0.223|-1.125|0.004
91702934|NCT02273908|183300259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0204||||0.175|TWO_SIDED|95.0|-0.0091|0.0499|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||0.0499|-0.0091|0.175
91702935|NCT02273908|183300259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0329||||0.017|TWO_SIDED|95.0|0.0058|0.06|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||0.0600|0.0058|0.017
91497199|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.273|STANDARD_ERROR_OF_MEAN|0.411||||90.0|-1.95|-0.596|||ANCOVA|||Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.596|-1.950|
91497200|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|STANDARD_ERROR_OF_MEAN|0.439||||90.0|-1.792|-0.346|||ANCOVA|||Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.346|-1.792|
91702936|NCT02273908|183300260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.697||||0.026|TWO_SIDED|95.0|0.552|8.842|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||8.842|0.552|0.026
91702937|NCT02273908|183300260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.292||||0.477|TWO_SIDED|95.0|-2.282|4.866|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.866|-2.282|0.477
91702938|NCT02273908|183300261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
91702939|NCT02273908|183300262|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
91497201|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.785|STANDARD_ERROR_OF_MEAN|0.418||||90.0|-1.475|-0.096|||ANCOVA|||Follow-up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.096|-1.475|
91497202|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|0.406||||90.0|-1.114|0.224|||ANCOVA|||Follow-up Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.224|-1.114|
91702940|NCT03301844|183300276|SUPERIORITY|||||||0.071|||||||Chi-squared||||"Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.~Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion."|||0.071
91702941|NCT03301844|183300277|OTHER|||||||0.7353|||||||Chi-squared||||"The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.~Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test."|||0.7353
91702942|NCT00501059|183300279|SUPERIORITY_OR_OTHER|||||||0.597|||||||Log Rank|||Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.||||0.597
91702943|NCT00501059|183300280|SUPERIORITY_OR_OTHER|||||||0.6125|||||||Log Rank|||Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.6125
91702944|NCT00501059|183300281|SUPERIORITY_OR_OTHER|||||||0.4505|||||||Log Rank|||Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4505
91702945|NCT00501059|183300281|SUPERIORITY_OR_OTHER|||||||0.229|||||||Log Rank|||Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.229
91702946|NCT00501059|183300281|SUPERIORITY_OR_OTHER|||||||0.3947|||||||Log Rank|||Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.3947
91702947|NCT00501059|183300281|SUPERIORITY_OR_OTHER|||||||0.5125|||||||Log Rank|||Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.5125
91702948|NCT00501059|183300282|SUPERIORITY_OR_OTHER|||||||0.9544|||||||Log Rank|||Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.9544
91702949|NCT00501059|183300282|SUPERIORITY_OR_OTHER|||||||0.4422|||||||Log Rank|||Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4422
91497203|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-1.133|1.025|||ANCOVA|||Extension Month 1; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||1.025|-1.133|
91497204|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.438|-0.235|||ANCOVA|||Extension Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.235|-2.438|
91702950|NCT00501059|183300282|SUPERIORITY_OR_OTHER|||||||0.611|||||||Log Rank|||Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.611
91702951|NCT00501059|183300283|OTHER||Cox Proportional Hazard|0.99||||0.9459|TWO_SIDED|95.0|0.8|1.24|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.24|0.80|0.9459
91702952|NCT00501059|183300284|OTHER||Cox Proportional Hazard|0.85||||0.2325|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.11|0.64|0.2325
91702953|NCT00501059|183300284|OTHER||Cox Proportional Hazard|1.12||||0.5072||95.0|0.8|1.55|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.55|0.80|0.5072
91702954|NCT00501059|183300284|OTHER||Cox Proportional Hazard|0.97||||0.901||95.0|0.62|1.52|||Log Rank|||Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.52|0.62|0.9010
91702955|NCT00501059|183300284|OTHER||Cox Proportional Hazard|1.0||||0.9979|TWO_SIDED|95.0|0.54|1.86|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.86|0.54|0.9979
91702956|NCT00501059|183300284|OTHER||Cox Proportional Hazard|0.93||||0.7455|TWO_SIDED|95.0|0.61|1.42|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.42|0.61|0.7455
91497205|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.462|STANDARD_ERROR_OF_MEAN|0.542||||90.0|-2.356|-0.568|||ANCOVA|||Extension Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.568|-2.356|
91497206|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|0.564||||90.0|-2.316|-0.454|||ANCOVA|||Extension Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.454|-2.316|
91497207|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.955|STANDARD_ERROR_OF_MEAN|0.559||||90.0|-1.877|-0.034|||ANCOVA|||Extension Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.034|-1.877|
91497208|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.588||||90.0|-1.97|-0.03|||ANCOVA|||Extension Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.030|-1.970|
91497209|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.655||||90.0|-2.041|0.121|||ANCOVA|||Extension Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.121|-2.041|
91497210|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.667|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.77|-0.565|||ANCOVA|||Extension Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.565|-2.770|
91497211|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.872|STANDARD_ERROR_OF_MEAN|0.692||||90.0|-3.013|-0.73|||ANCOVA|||Extension Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.730|-3.013|
91497212|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.887|STANDARD_ERROR_OF_MEAN|0.725||||90.0|-3.084|-0.69|||ANCOVA|||Extension Month 27; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.690|-3.084|
91497213|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.794|STANDARD_ERROR_OF_MEAN|0.891||||90.0|-4.264|-1.324|||ANCOVA|||Extension Month 30; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.324|-4.264|
91497214|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.287|STANDARD_ERROR_OF_MEAN|1.091||||90.0|-5.088|-1.485|||ANCOVA|||Extension Month 33; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.485|-5.088|
91497215|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.486|STANDARD_ERROR_OF_MEAN|0.857||||90.0|-2.901|-0.071|||ANCOVA|||Extension Month 36; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.071|-2.901|
91497216|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.131|STANDARD_ERROR_OF_MEAN|1.356||||90.0|-5.382|-0.88|||ANCOVA|||Extension Month 39; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.880|-5.382|
91497217|NCT00137046|182864527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.487|STANDARD_ERROR_OF_MEAN|0.866||||90.0|-2.918|-0.055|||ANCOVA|||Extension Follow Up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.055|-2.918|
91497218|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.144||||90.0|-0.981|-0.506|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.506|-0.981|
91497219|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.797|STANDARD_ERROR_OF_MEAN|0.167||||90.0|-1.073|-0.522|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.522|-1.073|
91497220|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|STANDARD_ERROR_OF_MEAN|0.171||||90.0|-0.949|-0.384|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.384|-0.949|
91497221|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.181||||90.0|-1.123|-0.528|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.528|-1.123|
91497222|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.19||||90.0|-0.923|-0.296|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.296|-0.923|
91497223|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.577|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.91|-0.245|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.245|-0.910|
91497224|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-0.962|-0.263|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.263|-0.962|
91497225|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.736|-0.034|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.034|-0.736|
91497226|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.211||||90.0|-0.197|0.497|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.497|-0.197|
91497227|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.16|0.492|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.492|-0.160|
91497228|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.208||||90.0|-0.274|0.411|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.411|-0.274|
91702957|NCT00501059|183300286|OTHER||Cox Proportional Hazard|0.96||||0.6038|TWO_SIDED|95.0|0.81|1.13|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.13|0.81|0.6038
91702958|NCT00501059|183300286|OTHER||Cox Proportional Hazard|0.95||||0.619|TWO_SIDED|95.0|0.79|1.15|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.15|0.79|0.6190
91702959|NCT00501059|183300286|OTHER||Cox Proportional Hazard|0.9||||0.4562|TWO_SIDED|95.0|0.67|1.2|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.20|0.67|0.4562
91702960|NCT00501059|183300287|OTHER||Cox Proportional Hazard|0.81||||0.0756|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.64|0.0756
91702961|NCT00501059|183300287|OTHER||Cox Proportional Hazard|0.79||||0.0661|TWO_SIDED|95.0|0.61|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.61|0.0661
91702962|NCT00501059|183300287|OTHER||Cox Proportional Hazard|0.53||||0.0014|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.79|0.36|0.0014
91702963|NCT00501059|183300287|OTHER||Cox Proportional Hazard|0.55||||0.0056|TWO_SIDED|95.0|0.36|0.84|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.84|0.36|0.0056
91702964|NCT00501059|183300287|OTHER||Cox Proportional Hazard|1.12||||0.6291||95.0|0.71|1.75|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.75|0.71|0.6291
91702965|NCT00501059|183300287|OTHER||Cox Proportional Hazard|1.03||||0.9161|TWO_SIDED|95.0|0.6|1.77|||Log Rank|||Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.77|0.60|0.9161
91702966|NCT00501059|183300287|OTHER||Cox Proportional Hazard|0.75||||0.538||95.0|0.3|1.87|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.87|0.30|0.5380
91497229|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.252||||90.0|-0.876|-0.043|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-0.876|
91702967|NCT00501059|183300287|OTHER||Cox Proportional Hazard|1.03||||0.9181|TWO_SIDED|95.0|0.55|1.95|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.95|0.55|0.9181
91702968|NCT00501059|183300287|OTHER||Cox Proportional Hazard|1.1||||0.4796|TWO_SIDED|95.0|0.84|1.45|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.45|0.84|0.4796
91702969|NCT02124759|183300289|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|Paired T-test||Null hypothesis is that high fat diet will have no effect on M value, the measure of insulin sensitivity for each intervention as assessed by clamp.||||>0.05
91702970|NCT04250298|183300292|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
91702971|NCT04250298|183300293|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
91702972|NCT04250298|183300294|OTHER|||||||0.228|||||||t-test, 2 sided|||||||0.228
91702973|NCT04250298|183300295|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
91702974|NCT04250298|183300296|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91702975|NCT04250298|183300297|OTHER|||||||0.318|||||||Fisher Exact|||||||0.318
91702976|NCT04250298|183300298|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
91497230|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.579|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.986|-0.172|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.172|-0.986|
91702977|NCT04250298|183300299|OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.548
91702978|NCT04250298|183300300|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
91702979|NCT04250298|183300301|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
91702980|NCT04250298|183300302|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
91702981|NCT04250298|183300308|OTHER|Mann-Whitney U test, Fisher Exact, Chi-Squared, Kolmogorv-Smirnow||||||0.919|||||||Wilcoxon (Mann-Whitney)|||"sub-population 1 vs. sub-population 2: Parametric and nonparametric univariate tests: t-test for independent samples, Mann-Whitney-U test, Fisher's exact test, chi-square homogeneity test; normal distribution check by Kolmogorov-Smirnov test with Lilliefors -significance correction, type I error = 10%).~Estimate the true effect size:~Two-sided 95% confidence intervals (depending on the nature of the data sets: parametric, non-parametric or Clopper-Pearson) are calculated for all parameters."||||0.919
91702982|NCT04250298|183300310|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
91702983|NCT04250298|183300311|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
91702984|NCT04250298|183300312|OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
91702985|NCT04250298|183300313|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
91702986|NCT04250298|183300318|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
91702987|NCT04250298|183300319|OTHER|||||||0.862|||||||t-test, 2 sided|||||||0.862
91497231|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.255||||90.0|-0.88|-0.04|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.040|-0.880|
91497232|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.265||||90.0|-0.822|0.053|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.053|-0.822|
91497233|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.268||||90.0|-1.372|-0.487|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.487|-1.372|
91497234|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823|STANDARD_ERROR_OF_MEAN|0.286||||90.0|-1.296|-0.351|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.351|-1.296|
91497235|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.525|STANDARD_ERROR_OF_MEAN|0.267||||90.0|-0.965|-0.084|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.084|-0.965|
91497236|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|STANDARD_ERROR_OF_MEAN|0.276||||90.0|-1.104|-0.191|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.191|-1.104|
91497237|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.853|STANDARD_ERROR_OF_MEAN|0.295||||90.0|-1.34|-0.367|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.367|-1.340|
91497238|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.303||||90.0|-0.89|0.111|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.111|-0.890|
91497239|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.636|STANDARD_ERROR_OF_MEAN|0.293||||90.0|-1.119|-0.153|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.153|-1.119|
91497240|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.522|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.0|-0.043|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-1.000|
91497241|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.346||||90.0|-1.315|-0.173|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.173|-1.315|
91497242|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.378|STANDARD_ERROR_OF_MEAN|0.628||||90.0|-2.42|-0.335|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.335|-2.420|
91497243|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-1.183|-0.258|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.258|-1.183|
91497244|NCT00137046|182864536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.323||||90.0|-0.594|0.472|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.472|-0.594|
91497245|NCT02268084|182864567|SUPERIORITY|||||||0.007|||||||ANOVA|||Null hypothesis is that the active treatment group does not differ from the sham group in changes in the PCL-M total scores.||||.007
91702988|NCT04250298|183300320|OTHER|||||||0.25|||||||Fisher Exact|||||||0.250
91497246|NCT02268084|182864568|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||.326
91497247|NCT01767155|182864594|OTHER||Kaplan-Meier|69.8|||||TWO_SIDED|95.0|63.6|75.1||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||75.1|63.6|
91497248|NCT01767155|182864594|OTHER||Kaplan-Meier|45.8|||||TWO_SIDED|95.0|39.5|52.0||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||52.0|39.5|
91497249|NCT01767155|182864594|OTHER||Kaplan-Meier|72.1|||||TWO_SIDED|95.0|66.0|77.3||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||77.3|66.0|
91497250|NCT01767155|182864594|OTHER||Kaplan-Meier|44.6|||||TWO_SIDED|95.0|38.2|50.7||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||50.7|38.2|
91497251|NCT01767155|182864594|OTHER||Hazard Ratio (HR)|1.06||||0.5441|TWO_SIDED|95.0|0.87|1.3|||Log Rank|2-sided||A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.||1.30|0.87|0.5441
91497252|NCT01767155|182864595|OTHER||Odds Ratio (OR)|0.87||||0.5907|TWO_SIDED|95.0|0.52|1.45|||Mantel Haenszel|2-sided test||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.||1.45|0.52|0.5907
91497253|NCT01767155|182864596|OTHER||Kaplan-Meier|46.7|||||TWO_SIDED|95.0|39.5|53.6||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months.||53.6|39.5|
91497254|NCT01767155|182864596|OTHER||Kaplan-Meier|20.6|||||TWO_SIDED|95.0|14.6|27.4||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||27.4|14.6|
91702989|NCT04250298|183300321|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91702990|NCT04250298|183300322|OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
91702991|NCT04250298|183300323|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
91497255|NCT01767155|182864596|OTHER||Kaplan-Meier|47.5|||||TWO_SIDED|95.0|40.0|54.7||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||54.7|40.0|
91497256|NCT01767155|182864596|OTHER||Kaplan-Meier|12.3|||||TWO_SIDED|95.0|6.9|19.3||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||19.3|6.9|
91497257|NCT01767155|182864596|OTHER||Hazard Ratio (HR)|0.89||||0.3089|TWO_SIDED|95.0|0.71|1.11|||Log Rank|2-sided||Hypothesis testing between the two treatment arms was performed using a log rank test.||1.11|0.71|0.3089
91497258|NCT01767155|182864597|OTHER||Odds Ratio (OR)|1.07||||0.6924|TWO_SIDED|95.0|0.76|1.52|||Mantel Haenszel|2-sided||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.||1.52|0.76|0.6924
91497259|NCT00371137|182864600|SUPERIORITY_OR_OTHER||||||>|0.001||95.0|||||Chi-squared|||Overall Comparison||||>0.001
91497260|NCT00371137|182864600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 4.5g||||<0.001
91702992|NCT04250298|183300324|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
91702993|NCT04250298|183300325|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
91702994|NCT04250298|183300328|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
91702995|NCT04250298|183300329|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
91702996|NCT00725101|183300364|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P-value for age over 65.|Regression, Logistic|||||||0.0074
91702997|NCT00725101|183300364|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||P-value for female physicians.|Regression, Logistic|||||||0.0028
91702998|NCT00725101|183300364|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Rheumatology versus PCP.|Regression, Logistic|||||||<0.0001
91702999|NCT00725101|183300364|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for other specialty versus PCP.|Regression, Logistic|||||||<0.0001
91703000|NCT00725101|183300364|SUPERIORITY_OR_OTHER|||||||0.0064||95.0||||P-value for use of opioids.|Regression, Logistic|||||||0.0064
91703001|NCT00725101|183300364|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for use of NSAIDs.|Regression, Logistic|||||||<0.0001
91703002|NCT00725101|183300364|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for number of medications participants were taking.|Regression, Logistic|||||||<0.0001
91703003|NCT00725101|183300365|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for GAD-7 score.|Regression, Logistic|||||||0.026
91703004|NCT00725101|183300365|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pregabalin use.|Regression, Logistic|||||||0.021
91703005|NCT00725101|183300365|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for NSAID use.|Regression, Logistic|||||||0.050
91703006|NCT05727306|183300411|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.25|1.46|||||Calculated as the odds of having a depressive episode in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.25|
91703007|NCT05727306|183300412|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.32|1.58|||||Calculated as the odds of having recurrent depressive disorder in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.58|1.32|
91703008|NCT05727306|183300413|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.3|1.51|||||Calculated as the odds of having anxiety in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.51|1.30|
91703009|NCT05727306|183300414|OTHER||Incidence rate ratio (IRR)|1.42|||||TWO_SIDED|95.0|1.37|1.46|||||Calculated as the incidence rate of attending primary care in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Incidence rate ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.37|
91703010|NCT05727306|183300415|OTHER||Hazard Ratio (HR)|8.26|||||TWO_SIDED|95.0|7.55|9.04|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||9.04|7.55|
91703011|NCT05727306|183300416|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.17|1.57|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.57|1.17|
91497261|NCT00371137|182864600|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 6.0g||||0.015
91497262|NCT02837783|182864622|SUPERIORITY|||||||0.283|||||||Wilcoxon rank sum test|||||||0.283
91497263|NCT04774328|182864632|OTHER|Analysis of Variance (ANOVA)|Median Difference (Final Values)|-39.28|STANDARD_ERROR_OF_MEAN|54.818||0.4812|TWO_SIDED|95.0|-152.97|74.4|||ANOVA|||||74.40|-152.97|0.4812
91497264|NCT04774328|182864633|OTHER|ANOVA|Mean Difference (Final Values)|-158.08|STANDARD_ERROR_OF_MEAN|64.232||0.0222|TWO_SIDED|95.0|-291.29|-24.87|||ANOVA|||"Applies to evoked measure of after coughing."||-24.87|-291.29|0.0222
91497265|NCT04774328|182864633|OTHER|ANOVA|Mean Difference (Final Values)|-55.04|STANDARD_ERROR_OF_MEAN|43.19||0.2158|TWO_SIDED|95.0|-144.61|34.53|||ANOVA|||"Applies to evoked measure for after sitting up."||34.53|-144.61|0.2158
91497266|NCT04774328|182864633|OTHER|ANOVA|Mean Difference (Final Values)|-78.73|STANDARD_ERROR_OF_MEAN|42.532||0.0777|TWO_SIDED|95.0|-166.93|9.48|||ANOVA|||"Applies to evoked measure of after ambulation."||9.48|-166.93|0.0777
91497267|NCT04774328|182864634|OTHER|ANOVA|Mean Difference (Final Values)|-9.375|STANDARD_ERROR_OF_MEAN|12.7245||0.469|TWO_SIDED|95.0|-35.764|17.014|||ANOVA|||Entry applies to OC 0-96 hours.||17.014|-35.764|0.4690
91497268|NCT04774328|182864634|OTHER|ANOVA|Mean Difference (Final Values)|-8.125|STANDARD_ERROR_OF_MEAN|14.5059||0.5811|TWO_SIDED|95.0|-38.208|21.958|||ANOVA|||Applies to OC 0 - Day 8.||21.958|-38.208|0.5811
91703012|NCT05727306|183300417|OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.14|1.87|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.87|1.14|
91703013|NCT05727306|183300418|OTHER||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|1.38|1.61|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.61|1.38|
91497269|NCT02927080|182864686|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the TA muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|9.54|STANDARD_ERROR_OF_MEAN|3.876||0.0138|TWO_SIDED|90.0|3.17|15.92|||ANCOVA|||D190 Percent change from baseline in TMV||15.92|3.17|0.0138
91497270|NCT02927080|182864686|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the BB muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|16.39|STANDARD_ERROR_OF_MEAN|4.032|<|0.0001|TWO_SIDED|90.0|9.75|23.02|||ANCOVA|||D190 Percent change from baseline in TMV||23.02|9.75|<0.0001
91703014|NCT00819780|183300435|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.871||||0.3531|TWO_SIDED|95.0|0.651|1.166|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.166|0.651|0.3531
91703015|NCT00819780|183300436|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.723||||0.1386|TWO_SIDED|95.0|0.47|1.111|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.111|0.470|0.1386
91703016|NCT00819780|183300437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.5497|TWO_SIDED|95.0|0.72|1.95|||Stratified exact test|Stratified by prior adjuvant oxaliplatin therapy|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||1.95|0.72|0.5497
91703017|NCT00819780|183300439|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.874||||0.3861|TWO_SIDED|95.0|0.645|1.185|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.185|0.645|0.3861
91703018|NCT00819780|183300442|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.651||||0.0286|TWO_SIDED|95.0|0.444|0.956|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.956|0.444|0.0286
91703019|NCT00819780|183300443|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.579||||0.0083|TWO_SIDED|95.0|0.386|0.869|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.869|0.386|0.0083
91703020|NCT00819780|183300444|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.606||||0.0934|TWO_SIDED|95.0|0.337|1.088|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.088|0.337|0.0934
91703021|NCT00819780|183300445|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.465||||0.0235|TWO_SIDED|95.0|0.239|0.902|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.902|0.239|0.0235
91703022|NCT00819780|183300446|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.9426|TWO_SIDED|95.0|0.55|2.12|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.12|0.55|0.9426
91703023|NCT00819780|183300447|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.52|2.15|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.15|0.52|1.0000
91497271|NCT02927080|182864688|SUPERIORITY||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|1.299||0.0359|TWO_SIDED|90.0|-4.86|-0.59|||ANCOVA|||D190 Absolute change from baseline in FF for the TA group administered ACE-083 when compared to Placebo in part 2||-0.59|-4.86|0.0359
91497272|NCT02927080|182864688|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.359||0.3582|TWO_SIDED|90.0|-3.49|0.99|||ANCOVA|||D190 Absolute change from baseline in FF for the BB group administered ACE-083 when compared to Placebo in part 2||0.99|-3.49|0.3582
91703024|NCT03301740|183300519|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.5|TWO_SIDED|95.0|0.8|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in intradialytic hypotension between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.7|0.8|0.5
91703025|NCT03301740|183300520|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-2.8||||0.2|TWO_SIDED|95.0|-6.9|1.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T change between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.4|-6.9|0.2
91497273|NCT02927080|182864689|SUPERIORITY||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|4.068||0.1945|TWO_SIDED|90.0|-11.97|1.41|||ANCOVA|||D190 Percent change from baseline in 6 Minute Walk Test (MWT) distance from baseline||1.41|-11.97|0.1945
91497274|NCT02927080|182864689|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|4.968||0.3451|TWO_SIDED|90.0|-3.48|12.86|||ANCOVA|||D190 Percent change from baseline in time to complete a 10 meter walk/run||12.86|-3.48|0.3451
91497275|NCT02927080|182864689|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|6.03||0.9402|TWO_SIDED|90.0|-9.47|10.37|||ANCOVA|||D190 Percent change from baseline in time to complete 4-stair climb (ascend)||10.37|-9.47|0.9402
91497276|NCT02927080|182864690|SUPERIORITY||Mean Difference (Final Values)|36.12|STANDARD_ERROR_OF_MEAN|14.18||0.0183|TWO_SIDED|90.0|11.78|60.46|||ANCOVA|||||60.46|11.78|0.0183
91497277|NCT02927080|182864691|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.7||0.0895|TWO_SIDED|90.0|0.09|5.69|||ANCOVA|||||5.69|0.09|0.0895
91497278|NCT02927080|182864692|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|3.459||0.5661|TWO_SIDED|90.0|-7.67|3.7|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for TA group part 2; compared to Placebo||3.70|-7.67|0.5661
91497279|NCT02927080|182864692|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.618||0.976|TWO_SIDED|90.0|-6.06|5.84|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for BB group part 2; compared to Placebo||5.84|-6.06|0.9760
91497280|NCT02670083|182864712|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.354|||TWO_SIDED|95.0|-0.86|0.53||||||||0.53|-0.86|
91497281|NCT02670083|182864713|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|95.0|-2.39|1.87||||||||1.87|-2.39|
91703026|NCT03301740|183300521|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.5||||0.1|TWO_SIDED|95.0|0.2|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T rise between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.2|0.1
91703027|NCT03301740|183300522|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Mean Difference (Final Values)|-0.8||||0.2|TWO_SIDED|95.0|-2.0|0.5||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in left ventricular GLS change between UF profiling and conventional HD. Wilcoxon (Mann-Whitney) tests were performed assessing the difference of the endpoint between the 2 treatment groups.||0.5|-2.0|0.2
91703028|NCT03301740|183300523|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-0.2||||0.9|TWO_SIDED|95.0|-2.0|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in nadir systolic BP between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.7|-2.0|0.9
91703029|NCT03301740|183300524|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.8|TWO_SIDED|95.0|0.7|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in failed target weight achievement between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.7|0.8
91703030|NCT03301740|183300525|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important cramping between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.1|0.4|0.9
91703031|NCT03301740|183300526|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.2|2.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important nausea/upset stomach between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.2|0.2|0.5
91497282|NCT02670083|182864714|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-2.08|1.88||||||||1.88|-2.08|
91497283|NCT02670083|182864715|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.076|||TWO_SIDED|95.0|-0.1|0.2||||||||0.20|-0.10|
91497284|NCT02670083|182864716|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.486|||TWO_SIDED|95.0|-0.62|1.29||||||||1.29|-0.62|
91497285|NCT02670083|182864717|SUPERIORITY||Least Squares Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.679|||TWO_SIDED|95.0|-1.43|5.18||||||||5.18|-1.43|
91497286|NCT02670083|182864718|SUPERIORITY||Least Squares Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|1.306|||TWO_SIDED|95.0|-1.35|3.79||||||||3.79|-1.35|
91497287|NCT02670083|182864720|SUPERIORITY||Least Squares Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.723|||TWO_SIDED|95.0|-1.95|0.9||||||||0.90|-1.95|
91497288|NCT02670083|182864721|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|95.0|-0.81|1.6||||||||1.60|-0.81|
91497289|NCT02670083|182864722|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|6.214|||TWO_SIDED|95.0|-13.64|10.86||||||||10.86|-13.64|
91497290|NCT02670083|182864723|SUPERIORITY||Least Squares Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.64|6.27||||||||6.27|-2.64|
91497291|NCT02670083|182864724|SUPERIORITY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|2.222|||TWO_SIDED|95.0|-3.45|5.32||||||||5.32|-3.45|
91497292|NCT02670083|182864730|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.24|0.22||||||||0.22|-0.24|
91497293|NCT02670083|182864731|SUPERIORITY||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-3.72|1.17||||||||1.17|-3.72|
91497294|NCT02670083|182864732|SUPERIORITY||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.1|0.89||||||||0.89|-0.10|
91497295|NCT05620563|182864737|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.28|0.87|||||Posterior mean difference with 95% credible interval is reported.|||0.87|-0.28|
91703032|NCT03301740|183300527|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|16.0|||Mixed Models Analysis|||Null hypothesis = no difference in clinically important Vomiting/throwing up score between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||16.0|0.1|1.0
91703033|NCT03301740|183300528|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.2||||0.04|TWO_SIDED|95.0|0.1|0.9||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important dizziness/lightheadedness between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||0.9|0.1|0.04
91703034|NCT03301740|183300529|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|3.1||||0.3|TWO_SIDED|95.0|0.3|32.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important racing heart/heart palpitations between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||32.4|0.3|0.3
91703035|NCT03301740|183300530|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.2|6.0||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important chest pain between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.0|0.2|1.0
91703036|NCT03301740|183300531|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.3||||0.7|TWO_SIDED|95.0|0.3|6.5||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important shortness of breath between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.5|0.3|0.7
91703037|NCT03301740|183300532|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.2|TWO_SIDED|95.0|0.3|1.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important thirst/dry mouth between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.2|0.3|0.2
91703038|NCT03301740|183300533|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.4|2.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important headache between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.3|0.4|0.8
91703039|NCT03301740|183300534|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|2.8||||0.02|TWO_SIDED|95.0|1.2|6.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important itching between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.6|1.2|0.02
91703040|NCT03301740|183300535|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.7|TWO_SIDED|95.0|0.5|2.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important restless legs/difficulty keeping legs still between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.6|0.5|0.7
91497296|NCT05620563|182864738|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-1.13|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-1.13|
91497297|NCT05620563|182864739|SUPERIORITY||Posterior Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.99|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.99|
91497298|NCT05620563|182864740|SUPERIORITY||Posterior Mean Difference|-0.55|||||TWO_SIDED|95.0|-3.82|2.69|||||Posterior mean difference with 95% credible interval is reported.|||2.69|-3.82|
91497299|NCT05620563|182864741|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.33|0.51|||||Posterior mean difference with 95% credible interval is reported.|||0.51|-0.33|
91703041|NCT03301740|183300536|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.5|TWO_SIDED|95.0|0.2|2.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important tingling/feeling of pins and needles between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.4|0.2|0.5
91703042|NCT02847182|183300537|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.83|TWO_SIDED|95.0|-1.58|3.86|||t-test, 2 sided|||Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.||3.86|-1.58|0.83
91703043|NCT00962091|183300570|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.9|||||TWO_SIDED|90.0|1.52|2.37|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||2.37|1.52|
91703044|NCT00962091|183300571|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.08|1.78|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.78|1.08|
91703045|NCT00962091|183300577|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.66|1.06|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.06|0.66|
91703046|NCT00962091|183300578|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.8|1.34|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.34|0.80|
91703047|NCT00962091|183300579|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|90.0|0.68|1.32|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUC values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.32|0.68|
91703048|NCT02172040|183300600|NON_INFERIORITY|Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm.|||||=|0.001|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine.||||= 0.001
91703049|NCT02172040|183300600|SUPERIORITY||||||=|0.491|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The secondary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with placebo was superior to treatment with celecoxib. This was only to be performed if statistical significance was achieved for the primary comparison.||||= 0.491
91703050|NCT02172040|183300601|OTHER||||||=|0.166|||||||Chi-squared|||||||= 0.166
91703051|NCT02172040|183300602|SUPERIORITY|||||||0.177|||||||t-test, 1 sided|||||||0.177
91703052|NCT02172040|183300602|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703053|NCT02172040|183300602|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703054|NCT02172040|183300602|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703055|NCT02172040|183300602|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703056|NCT02172040|183300602|SUPERIORITY||||||=|0.719|||||||t-test, 1 sided|||||||= 0.719
91703057|NCT02172040|183300603|SUPERIORITY||||||=|0.069|||||||t-test, 1 sided|||||||= 0.069
91703058|NCT02172040|183300603|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
91703059|NCT02172040|183300603|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703060|NCT02172040|183300603|SUPERIORITY||||||=|0.097|||||||t-test, 1 sided|||||||= 0.097
91497300|NCT05620563|182864742|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.35|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.35|
91497301|NCT05620563|182864743|SUPERIORITY||Posterior Mean Difference|2.2|||||TWO_SIDED|95.0|-5.7|9.99|||||Posterior mean difference with 95% credible interval is reported.|||9.99|-5.70|
91497302|NCT05620563|182864744|SUPERIORITY||Posterior Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.39|
91497303|NCT05620563|182864745|SUPERIORITY||Posterior Mean Difference|24.16|||||TWO_SIDED|95.0|-115.48|166.06|||||Posterior mean difference with 95% credible interval is reported.|||166.06|-115.48|
91497304|NCT05620563|182864746|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
91497305|NCT01442493|182864800|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
91497306|NCT01442493|182864801|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
91497307|NCT01442493|182864802|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91497308|NCT01442493|182864803|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
91497309|NCT01442493|182864804|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
91497310|NCT01442493|182864805|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91703061|NCT02172040|183300603|SUPERIORITY||||||=|0.064|||||||t-test, 1 sided|||||||= 0.064
91703062|NCT02172040|183300603|SUPERIORITY||||||=|0.924|||||||t-test, 1 sided|||||||= 0.924
91703063|NCT02172040|183300604|SUPERIORITY||||||=|0.038|||||||t-test, 1 sided|||||||= 0.038
91703064|NCT02172040|183300604|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703065|NCT02172040|183300604|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703066|NCT02172040|183300604|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91497311|NCT01442493|182864806|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
91703067|NCT02172040|183300604|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703068|NCT02172040|183300604|SUPERIORITY||||||=|0.562|||||||t-test, 1 sided|||||||= 0.562
91703069|NCT02172040|183300605|SUPERIORITY||||||=|0.104|||||||t-test, 1 sided|||||||= 0.104
91703070|NCT02172040|183300605|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703071|NCT02172040|183300605|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703072|NCT02172040|183300605|SUPERIORITY||||||=|0.002|||||||t-test, 1 sided|||||||= 0.002
91703073|NCT02172040|183300605|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703074|NCT02172040|183300605|SUPERIORITY||||||=|0.419|||||||t-test, 1 sided|||||||= 0.419
91703075|NCT02172040|183300606|SUPERIORITY||||||=|0.028|||||||t-test, 1 sided|||||||= 0.028
91703076|NCT02172040|183300606|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703077|NCT02172040|183300606|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703078|NCT02172040|183300606|SUPERIORITY||||||=|0.051|||||||t-test, 1 sided|||||||= 0.051
91703079|NCT02172040|183300606|SUPERIORITY||||||=|0.074|||||||t-test, 1 sided|||||||= 0.074
91497312|NCT03454997|182864833|SUPERIORITY||Mean Difference (Net)|5.5|||||TWO_SIDED|95.0|3.9|7.1||||||comparison of baseline and 6 months across both groups||7.1|3.9|
91703080|NCT02172040|183300606|SUPERIORITY||||||=|0.878|||||||t-test, 1 sided|||||||= 0.878
91703081|NCT02172040|183300607|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703082|NCT02172040|183300608|OTHER||||||=|0.977|||||||t-test, 1 sided|||||||= 0.977
91703083|NCT02172040|183300609|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703084|NCT02172040|183300610|OTHER||||||=|0.527|||||||t-test, 1 sided|||||||= 0.527
91703085|NCT02172040|183300611|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703086|NCT02172040|183300611|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703087|NCT02172040|183300611|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91703088|NCT02172040|183300611|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
91703089|NCT04908202|183300614|SUPERIORITY||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.67|3.13|||Cochran-Mantel-Haenszel|||||3.13|1.67|<0.0001
91703090|NCT04908202|183300615|SUPERIORITY||ADJUSTED MEAN DIFFERENCE|-0.5051|||<|0.0001|TWO_SIDED|95.0|-0.6709|-0.3392|||ANCOVA|||||-0.3392|-0.6709|<0.0001
91703091|NCT04908202|183300616|SUPERIORITY||ADJUSTED MEAN DIFFERENCE|-0.1688|||<|0.0001|TWO_SIDED|95.0|-0.2442|-0.0933|||ANCOVA|||||-0.0933|-0.2442|<0.0001
91703092|NCT04908202|183300617|SUPERIORITY||Odds Ratio (OR)|14.08|||<|0.0001|TWO_SIDED|95.0|7.19|27.59|||Cochran-Mantel-Haenszel|||||27.59|7.19|<0.0001
91497313|NCT03454997|182864833|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||||||between groups differences of change between baseline and 6 months||1.1|-2.3|
91497314|NCT03454997|182864834|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||leading behavioral weight loss group baseline to 6 months comparison||0.4|-1.4|
91497315|NCT03454997|182864834|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-2.0|1.0||||||leading behavioral weight loss group between group comparison of change||1.0|-2.0|
91497316|NCT03454997|182864834|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.4|0.2||||||completing weight ins baseline to 6 month comparison||0.2|-1.4|
91497317|NCT03454997|182864834|SUPERIORITY||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.5|0.5||||||completing weigh ins between groups comparison of change||0.5|-2.5|
91703093|NCT04908202|183300618|SUPERIORITY||ADJUSTED MEAN DIFFERENCE|6.631|||<|0.0001|TWO_SIDED|95.0|3.481|9.781|||ANCOVA|||||9.781|3.481|<0.0001
91703094|NCT04908202|183300619|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5699|TWO_SIDED|95.0|0.74|1.75|||Cochran-Mantel-Haenszel|||||1.75|0.74|0.5699
91703095|NCT04908202|183300620|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0012|TWO_SIDED|95.0|1.33|3.26|||Cochran-Mantel-Haenszel|||||3.26|1.33|0.0012
91703096|NCT04908202|183300621|SUPERIORITY||ADJUSTED MEAN DIFFERENCE|2.6|||<|0.0001|TWO_SIDED|95.0|1.4|3.9|||ANCOVA|||||3.9|1.4|<0.0001
91703097|NCT04908202|183300622|SUPERIORITY||Odds Ratio (OR)|1.8||||0.027|TWO_SIDED|95.0|1.07|3.03|||Cochran-Mantel-Haenszel|||||3.03|1.07|0.0270
91703098|NCT04908202|183300623|SUPERIORITY||ADJUSTED MEAN DIFFERENCE|0.1596||||0.7194|TWO_SIDED|95.0|-0.7114|1.0306|||ANCOVA|||||1.0306|-0.7114|0.7194
91703099|NCT03030118|183300707|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||For the primary outcome (SLICC classification criteria count \[SLICC score\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.||||0.72
91703100|NCT03030118|183300708|SUPERIORITY|||||||0.81|||||||Regression, Cox|||Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.||||0.81
91703101|NCT03030118|183300709|SUPERIORITY|||||||0.74|||||||Regression, Logistic|||"For the SLEDAI score, we combined responses to model the following groups:~* Score of 0 or 1~* Score of 2 or 3~* Score of 4, 6, or 8"||||0.74
91703102|NCT03030118|183300710|SUPERIORITY|||||||0.77|||||||Regression, Logistic|Ordinal logistic regression||"For analysis, we combined responses ≥3 to model the following groups:~* Score of 0~* Score of 1~* Score of 2~* Score of 3 or higher"||||0.77
91703103|NCT03030118|183300711|SUPERIORITY|||||||0.386|||||||t-test, 2 sided|Paired t-test||||||0.386
91703104|NCT03030118|183300712|SUPERIORITY|||||||0.497|||||||t-test, 2 sided|Paired t-test||||||0.497
91703105|NCT03030118|183300713|SUPERIORITY|||||||0.99|||||||Regression, Logistic|Ordinal logistic regression||||||0.99
91703106|NCT03030118|183300714|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91703107|NCT03030118|183300715|NON_INFERIORITY|Outcome with hydroxychloroquine is hypothesized to be not inferior to outcome with placebo.|||||>|0.5|||||||Fisher Exact|||||||>0.5
91703108|NCT03030118|183300716|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91703109|NCT03030118|183300717|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91703110|NCT00454818|183300742|SUPERIORITY_OR_OTHER|||||||0.078||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.078
91497318|NCT03454997|182864834|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.2|0.3||||||managing a group session baseline to 6 months comparison||0.3|-1.2|
91497319|NCT03454997|182864834|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.0|1.1||||||managing a group session between groups comparison of change||1.1|-2.0|
91497320|NCT03454997|182864835|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-2.0|2.9||||||comparison between baseline and 6 months across groups||2.9|-2.0|
91497321|NCT03454997|182864835|SUPERIORITY||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-9.1|0.8||||||between groups comparison of change post training to 6 months||0.8|-9.1|
91497322|NCT03454997|182864836|SUPERIORITY||Mean Difference (Net)|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||comparison of baseline to 6 months across both groups||0.3|-6.9|
91530801|NCT01058863|182937661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.73|STANDARD_ERROR_OF_MEAN|3.686|<|0.001|TWO_SIDED|95.0|20.47|34.99||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||34.99|20.47|<0.001
91535603|NCT00991276|182949770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.58|STANDARD_ERROR_OF_MEAN|3.26||0.0215|TWO_SIDED|95.0|-14.03|-1.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.14|-14.03|0.0215
91703111|NCT00454818|183300742|SUPERIORITY_OR_OTHER|||||||0.515||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.515
91703112|NCT00454818|183300742|SUPERIORITY_OR_OTHER|||||||0.098||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.098
91703113|NCT00766467|183300759|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3
91497323|NCT03454997|182864836|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-11.4|1.8||||||comparison of between group differences baseline to 6 months||1.8|-11.4|
91497324|NCT03454997|182864837|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||Comparison of Baseline \& 6 Months across both groups||1.1|-0.4|
91497325|NCT03454997|182864837|SUPERIORITY||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.0|0.2||||||Between Groups Differences of Change between Baseline \& 6 Months||0.2|-2.0|
91497326|NCT03454997|182864838|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.3||||||comparison of between group differences baseline to 6 months||3.3|-4.5|
91497327|NCT03454997|182864838|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-3.1|0.2||||||comparison of baseline to 6 months across groups||0.2|-3.1|
91497328|NCT03454997|182864839|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.1|-1.6||||||comparison of baseline and 6 months across groups||-1.6|-6.1|
91497329|NCT03454997|182864839|SUPERIORITY||Mean Difference (Net)|-6.6|||||TWO_SIDED|95.0|-20.2|6.9||||||between groups differences of change between baseline to 6 months||6.9|-20.2|
91497330|NCT05025241|182864883|OTHER||||||<|0.0001|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||<0.0001
91497331|NCT05025241|182864884|OTHER|||||||0.0003|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0003
91497332|NCT05025241|182864885|OTHER|Change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
91497333|NCT05025241|182864886|OTHER|Change from baseline||||||0.0005|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0005
91497334|NCT05025241|182864887|OTHER|||||||0.0647|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0647
91703114|NCT02332239|183300797|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|4.11||0.07|TWO_SIDED||||||Mixed effects longitudinal regression||d=0.37|BDI Score where baseline \>=20: 8 week||||0.07
91703115|NCT02332239|183300798|SUPERIORITY||Median Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|2.62||0.01|TWO_SIDED||||||quantile regression models|Controlled for baseline and gender|d=0.46|CTS Score where baseline \>=4: 8 week||||0.01
91530802|NCT01058863|182937661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|3.686|<|0.0001|TWO_SIDED|95.0|25.84|40.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.35|25.84|<0.0001
91703116|NCT02332239|183300801|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
91703117|NCT00662558|183300811|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.|Risk Difference (RD)|0.091||||||95.0|0.0255|0.1565||||||||0.1565|0.0255|
91703118|NCT00662558|183300811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|||If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.||||0.008
91703119|NCT00662558|183300812|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234||95.0|-0.53|0.13|||ANCOVA||The mean difference reported is the least squares (LS) mean difference.|The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.||0.13|-0.53|0.234
91703120|NCT00662558|183300813|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.76||0.595||95.0|-4.39|2.52|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.52|-4.39|0.595
91703121|NCT00662558|183300814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.829
91703122|NCT00662558|183300815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.470
91703123|NCT00662558|183300816|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.32||0.339||95.0|-0.95|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.95|0.339
91703124|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.741||95.0|-0.36|0.25|||ANCOVA||The mean difference reported is the LS mean difference.|How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.25|-0.36|0.741
91703125|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.796||95.0|-0.38|0.29|||ANCOVA||The mean difference reported is the LS mean difference.|Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.29|-0.38|0.796
91703126|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.492||95.0|-0.41|0.2|||ANCOVA||The mean difference reported is the LS mean difference.|Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.20|-0.41|0.492
91703127|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.893||95.0|-0.28|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.28|0.893
91497335|NCT05025241|182864888|OTHER|Change from baseline||||||0.0984|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0984
91530803|NCT01058863|182937661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.61|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|18.36|32.85||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||32.85|18.36|<0.0001
91530804|NCT03786094|182937685|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.445|TWO_SIDED|96.0|0.85|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.85|0.4450
91530805|NCT03786094|182937686|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6158|TWO_SIDED|96.0|0.81|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.81|0.6158
91530806|NCT03786094|182937687|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6126|TWO_SIDED|99.9|0.66|1.77|||t-test, 2 sided|||||1.77|0.66|0.6126
91703128|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.618||95.0|-0.4|0.24|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.24|-0.40|0.618
91703129|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.44||95.0|-0.19|0.43|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.43|-0.19|0.440
91703130|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.806||95.0|-0.25|0.32|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.32|-0.25|0.806
91703131|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.739||95.0|-0.38|0.27|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.27|-0.38|0.739
91703132|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.992||95.0|-0.32|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.32|0.992
91703133|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.793||95.0|-0.28|0.36|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.36|-0.28|0.793
91703134|NCT00662558|183300817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.973||95.0|-0.27|0.28|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.28|-0.27|0.973
91703135|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.51||0.392||95.0|-4.26|1.67|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.67|-4.26|0.392
91703136|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.67||0.691||95.0|-3.94|2.61|||ANCOVA||The mean difference reported is the LS mean difference.|Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.61|-3.94|0.691
91497336|NCT05025241|182864889|OTHER|Change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
91530807|NCT03844321|182937741|SUPERIORITY||Difference in Slopes|-0.02||||0.82|TWO_SIDED|95.0|-0.24|0.19||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|df = 1607|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.19|-0.24|.820
91497337|NCT05025241|182864890|OTHER|Change from baseline||||||0.0191|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0191
91497338|NCT05025241|182864891|OTHER|change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
91703137|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.45||0.549||95.0|-3.7|1.97|||ANCOVA||The mean difference reported is the LS mean difference.|Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.97|-3.70|0.549
91530808|NCT03844321|182937741|SUPERIORITY||Difference in Slopes|-0.08||||0.11|TWO_SIDED|95.0|-0.18|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1147|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.02|-0.18|.110
91530809|NCT03844321|182937742|SUPERIORITY||Difference in Slopes|-0.03||||0.284|TWO_SIDED|95.0|-0.07|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df= 1726|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.07|.284
91530810|NCT03844321|182937742|SUPERIORITY||Difference in Slopes|0.01||||0.394|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1018|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.394
91530811|NCT03844321|182937743|SUPERIORITY||Difference in Slopes|0.03||||0.431|TWO_SIDED|95.0|-0.04|0.09||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1591|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.09|-0.04|.431
91703138|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.336||95.0|-0.67|0.23|||ANCOVA||The mean difference reported is the LS mean difference.|Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.23|-0.67|0.336
91703139|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.69||0.37||95.0|-4.83|1.8|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.80|-4.83|0.370
91703140|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|1.34||0.341||95.0|-3.9|1.35|||ANCOVA||The mean difference reported is the LS mean difference.|Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.35|-3.90|0.341
91703141|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.604||95.0|-2.85|1.66|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.66|-2.85|0.604
91703142|NCT00662558|183300818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.14||0.547||95.0|-2.92|1.55|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.55|-2.92|0.547
91703143|NCT00662558|183300819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|||Optimal sleep was analyzed using CMH general association test.||||0.196
91703144|NCT00662558|183300820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.91||0.252||95.0|-1.56|5.94|||ANCOVA||The mean difference reported is the LS mean difference.|Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||5.94|-1.56|0.252
91703145|NCT00662558|183300820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.88||0.798||95.0|-3.21|4.17|||ANCOVA||The mean difference reported is the LS mean difference.|Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.17|-3.21|0.798
91703146|NCT00662558|183300820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.92||0.7||95.0|-3.03|4.51|||ANCOVA||The mean difference reported is the LS mean difference.|Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.51|-3.03|0.700
91703147|NCT00662558|183300820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.72||0.902||95.0|-3.16|3.59|||ANCOVA||The mean difference reported is the LS mean difference.|Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||3.59|-3.16|0.902
91703148|NCT00662558|183300820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.46||0.581||95.0|-0.65|1.16|||ANCOVA||The mean difference reported is the LS mean difference.|Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.16|-0.65|0.581
91703149|NCT00662558|183300821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 1.||||0.614
91703150|NCT00662558|183300821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 3.||||0.786
91530812|NCT03844321|182937743|SUPERIORITY||Difference in Slopes|0.05|||<|0.001|TWO_SIDED|95.0|0.02|0.08||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1159|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.08|0.02|<.001
91703151|NCT00662558|183300821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 6/ET.||||0.044
91703152|NCT00662558|183300822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.870
91703153|NCT00662558|183300823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.545
91703154|NCT00662558|183300824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||Cochran-Mantel-Haenszel|||CMH test adjusted for center was used to compare the two treatment groups.||||0.218
91703155|NCT00987402|183300847|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||generalized estimating equation|||Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.||||<0.05
91530813|NCT03844321|182937744|SUPERIORITY||Difference in Slopes|-0.01||||0.399|TWO_SIDED|95.0|-0.05|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1601|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.05|.399
91703156|NCT03000530|183300899|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The Mixed Effect Model for Repeated Measures (MMRM) included the change from baseline in HAM-D total score at each visit as the dependent variables.||||-3.9|-10.2|< 0.0001
91703157|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.99||0.0223|TWO_SIDED|95.0|-4.3|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 2||-0.3|-4.3|0.0223
91703158|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.18||0.001|TWO_SIDED|95.0|-6.4|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 3||-1.7|-6.4|0.0010
91703159|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.27||0.0233|TWO_SIDED|95.0|-5.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 4||-0.4|-5.5|0.0233
91703160|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|-6.6|-1.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 5||-1.1|-6.6|0.0066
91703161|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.4||0.0019|TWO_SIDED|95.0|-7.3|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 6||-1.7|-7.3|0.0019
91703162|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.53||0.0043|TWO_SIDED|95.0|-7.6|-1.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 7||-1.5|-7.6|0.0043
91703163|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0318|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 8||-0.3|-6.4|0.0318
91703164|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 15||-3.9|-10.2|< 0.0001
91703165|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.76||0.0064|TWO_SIDED|95.0|-8.4|-1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 21||-1.4|-8.4|0.0064
91703166|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.77||0.0243|TWO_SIDED|95.0|-7.6|-0.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 28||-0.5|-7.6|0.0243
91703167|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.2285|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 35||1.4|-6.0|0.2285
91703168|NCT03000530|183300966|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.212|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 42||1.4|-6.0|0.2120
91703169|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0884|TWO_SIDED|95.0|0.8|24.1|||Generalized Estimating Equation|Statistics are from a generalized estimating equation (GEE) method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 2||24.1|0.8|0.0884
91703170|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0732|TWO_SIDED|95.0|0.9|6.4|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||6.4|0.9|0.0732
91703171|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|9.6||||0.0002|TWO_SIDED|95.0|2.9|31.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||31.6|2.9|0.0002
91703172|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|6.7||||0.0006|TWO_SIDED|95.0|2.3|19.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||19.7|2.3|0.0006
91703173|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0379|TWO_SIDED|95.0|1.1|8.9|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||8.9|1.1|0.0379
91703174|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0468|TWO_SIDED|95.0|1.0|9.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||9.0|1.0|0.0468
91703175|NCT03000530|183300967|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2208|TWO_SIDED|95.0|0.7|5.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||5.6|0.7|0.2208
91703176|NCT03000530|183300968|SUPERIORITY||Odds Ratio (OR)|1.5||||0.43|TWO_SIDED|95.0|0.6|3.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||3.7|0.6|0.4300
91703177|NCT03000530|183300968|SUPERIORITY||Odds Ratio (OR)|5.3||||0.0005|TWO_SIDED|95.0|2.1|13.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||13.3|2.1|0.0005
91703178|NCT03000530|183300968|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0172|TWO_SIDED|95.0|1.2|8.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||8.0|1.2|0.0172
91703179|NCT03000530|183300968|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0221|TWO_SIDED|95.0|1.2|7.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||7.3|1.2|0.0221
91703180|NCT03000530|183300968|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4139|TWO_SIDED|95.0|0.6|3.5|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||3.5|0.6|0.4139
91703181|NCT03000530|183300968|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2332|TWO_SIDED|95.0|0.7|4.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||4.3|0.7|0.2332
91703182|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.38||0.0836|TWO_SIDED|95.0|-5.1|0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 2||0.3|-5.1|0.0836
91703183|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.32||0.0864|TWO_SIDED|95.0|-8.6|0.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 8||0.6|-8.6|0.0864
91703184|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.38||0.0021|TWO_SIDED|95.0|-12.3|-2.8|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 15||-2.8|-12.3|0.0021
91703185|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.69||0.0157|TWO_SIDED|95.0|-12.0|-1.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 21||-1.3|-12.0|0.0157
91703186|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.69||0.0533|TWO_SIDED|95.0|-10.6|0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 28||0.1|-10.6|0.0533
91703187|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.87||0.2878|TWO_SIDED|95.0|-8.8|2.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 35||2.6|-8.8|0.2878
91703188|NCT03000530|183300969|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.7||0.4664|TWO_SIDED|95.0|-7.4|3.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 42||3.4|-7.4|0.4664
91703189|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.87||0.0391|TWO_SIDED|95.0|-3.6|-0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 2||-0.1|-3.6|0.0391
91703190|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.29||0.0516|TWO_SIDED|95.0|-5.1|0.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 8||0.0|-5.1|0.0516
91703191|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.32||0.0008|TWO_SIDED|95.0|-7.3|-2.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 15||-2.0|-7.3|0.0008
91703192|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0282|TWO_SIDED|95.0|-6.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 21||-0.4|-6.5|0.0282
91703193|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.56||0.1686|TWO_SIDED|95.0|-5.3|0.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 28||0.9|-5.3|0.1686
91497339|NCT05025241|182864892|OTHER|change from baseline||||||0.171|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1710
91703194|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.75||0.2488|TWO_SIDED|95.0|-5.5|1.5|||Mixed Effect Model for Repeated Measures|||Day 35||1.5|-5.5|0.2488
91703195|NCT03000530|183300972|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.76||0.2037|TWO_SIDED|95.0|-5.7|1.2|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 42||1.2|-5.7|0.2037
91703196|NCT03000530|183300973|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0048|TWO_SIDED|95.0|1.7|17.9|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||17.9|1.7|0.0048
91703197|NCT03000530|183300973|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0007|TWO_SIDED|95.0|2.5|29.5|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||29.5|2.5|0.0007
91703198|NCT03000530|183300973|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0113|TWO_SIDED|95.0|1.4|13.6|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||13.6|1.4|0.0113
91703199|NCT03000530|183300973|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0227|TWO_SIDED|95.0|1.2|12.8|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||12.8|1.2|0.0227
91703200|NCT03000530|183300973|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1516|TWO_SIDED|95.0|0.7|7.2|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||7.2|0.7|0.1516
91703201|NCT03000530|183300973|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0793|TWO_SIDED|95.0|0.9|8.3|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||8.3|0.9|0.0793
91703202|NCT01672294|183300977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5376|||<|0.511|TWO_SIDED|95.0|-1.0776|2.1528||Between Outlook Intervention and Attention Control caregivers at 5 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.1528|-1.0776|<0.511
91497340|NCT05025241|182864893|OTHER|change from baseline||||||0.0066|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0066
91497341|NCT05025241|182864894|OTHER|change form baseline||||||0.1094|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1094
91497342|NCT05025241|182864895|OTHER|change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
91497343|NCT05025241|182864896|OTHER|change from baseline||||||0.0326|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0326
91497344|NCT00110149|182864966|OTHER|As the study was not able to be completed the simple number of patients per outcome is listed.|||||||||||||||||The trial was to measure the response rate and EFS of patients but the manufacturer of the investigational agent closed and sold the agent to a new company so the trial was not able to be completed.|||
91497345|NCT01018186|182864978|SUPERIORITY_OR_OTHER||Ratio|1.67|||||TWO_SIDED|95.0|1.34|2.08|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||2.08|1.34|
91497346|NCT01018186|182864978|SUPERIORITY_OR_OTHER||Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.13|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||2.13|1.29|
91703203|NCT01672294|183300977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4275||||0.6348|TWO_SIDED|95.0|-1.3505|2.2055||Between Outlook Intervention and Attention Control caregivers at 8 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.2055|-1.3505|0.6348
91497347|NCT01018186|182864978|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.83|1.33|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.33|0.83|
91497348|NCT01018186|182864978|SUPERIORITY_OR_OTHER||Ratio|1.52|||||TWO_SIDED|95.0|1.22|1.89|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||1.89|1.22|
91497349|NCT01018186|182864978|SUPERIORITY_OR_OTHER||Ratio|1.43|||||TWO_SIDED|95.0|1.11|1.84|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||1.84|1.11|
91497350|NCT01018186|182864978|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.38|0.87|
91497351|NCT01018186|182864979|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.67|||<|0.001|TWO_SIDED|95.0|1.34|2.08|||ANCOVA|||||2.08|1.34|<0.001
91497352|NCT01018186|182864979|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||ANCOVA|||||1.89|1.22|<0.001
91497353|NCT01018186|182864980|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||ANCOVA|||||2.13|1.29|<0.001
91497354|NCT01018186|182864980|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||ANCOVA|||||1.84|1.11|0.006
91703204|NCT01672294|183300978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6836||||0.5225|TWO_SIDED|95.0|-1.4278|2.795|||Mixed Models Analysis|||Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.7950|-1.4278|0.5225
91497355|NCT01018186|182864981|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.05||||0.674|TWO_SIDED|95.0|0.83|1.33|||ANCOVA|||||1.33|0.83|0.674
91497356|NCT01018186|182864981|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.09||||0.444|TWO_SIDED|95.0|0.87|1.38|||ANCOVA|||||1.38|0.87|0.444
91497357|NCT03552198|182865048|OTHER|||||||0.964|||||||ANCOVA|ANCOVA, adjusted for baseline measures, tested for differences between intervention and control groups in preventative behaviours at 4 weeks||We predicted that the groups receiving the alternative format of air quality notifications would report greater frequency of behaviour change at 4 weeks compared to the groups receiving the usual format.||||.964
91497358|NCT03552198|182865049|OTHER|||||||0.043|||||||Chi-squared|χ2(1)=4.11, V=0.229||We predicted that more respondents in the intervention groups (i.e. receiving alternative health advice) would consider making permanent changes to their daily travel route, exercise location or exercise time compared to the control groups||||0.043
91497359|NCT03552198|182865050|OTHER||||||>|0.05|||||||Fisher Exact|||We predicted that the alternative health advice would lead to greater actual behaviour change compared to the usual format||||>0.05
91497360|NCT03552198|182865051|OTHER||||||>|0.05|||||||ANCOVA|ANCOVA, adjusted for baseline intentions, tested for differences between groups in intentions in relation to an high-air-pollution scenario at 4 weeks||We predicted that the alternative format would lead to stronger intentions to adhere to recommendations associated with an hypothetical high air pollution episode compared to the usual format.||||>0.05
91497361|NCT00923247|182865090|SUPERIORITY_OR_OTHER|||||||0.019|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).||||0.019
91497362|NCT00923247|182865091|SUPERIORITY_OR_OTHER|||||||0.052|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).||||0.052
91497363|NCT00923247|182865092|SUPERIORITY_OR_OTHER|||||||0.44|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.||||0.440
91497364|NCT00923247|182865093|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.||||0.016
91497365|NCT00923247|182865094|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.||||0.010
91497366|NCT01691781|182865114|SUPERIORITY|||||||0.049||||||This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.049
91497367|NCT01691781|182865114|SUPERIORITY|||||||0.8||||||This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).||||0.80
91497368|NCT01691781|182865115|SUPERIORITY|||||||0.22||||||This p-value reflects the comparison of means among the primary hyperparathyroidism group only.|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.22
91703205|NCT01672294|183300978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2764||||0.1972|TWO_SIDED|95.0|-0.6728|3.2257|||Mixed Models Analysis|||Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||3.2257|-0.6728|0.1972
91703206|NCT01672294|183300979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9358|||<|0.3332|TWO_SIDED|95.0|-0.9726|2.8443|||Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.8443|-0.9726|<0.3332
91497369|NCT01691781|182865115|SUPERIORITY|||||||0.86||||||This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.86
91497370|NCT01691781|182865116|SUPERIORITY|||||||0.48||||||This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.48
91497371|NCT01691781|182865116|SUPERIORITY|||||||0.8||||||This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.80
91497372|NCT03978520|182865117|SUPERIORITY||Response Rate Difference|12.8|||=|0.081|TWO_SIDED|95.0|-1.6|27.1|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||27.1|-1.6|=0.081
91497373|NCT03978520|182865117|SUPERIORITY||Response Rate Difference|16.9|||=|0.028|TWO_SIDED|95.0|1.8|31.9|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||31.9|1.8|=0.028
91497374|NCT03978520|182865117|SUPERIORITY||Response Rate Difference|-4.7|||=|0.566|TWO_SIDED|95.0|-20.8|11.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||11.4|-20.8|=0.566
91497375|NCT03978520|182865118|SUPERIORITY||Response Rate Difference|18.3|||=|0.013|TWO_SIDED|95.0|3.9|32.6|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||32.6|3.9|=0.013
91703207|NCT01672294|183300979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6929||||0.3842|TWO_SIDED|95.0|-0.8783|2.2642||Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks||2.2642|-0.8783|0.3842
91497376|NCT03978520|182865118|SUPERIORITY||Response Rate Difference|18.1|||=|0.018|TWO_SIDED|95.0|3.0|33.2|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||33.2|3.0|=0.018
91497377|NCT03978520|182865118|SUPERIORITY||Response Rate Difference|-1.2|||=|0.882|TWO_SIDED|95.0|-17.6|15.2|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||15.2|-17.6|=0.882
91530814|NCT03844321|182937744|SUPERIORITY||Difference in Slopes|0.02||||0.048|TWO_SIDED|95.0|0.0|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1171|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|0.00|.048
91530815|NCT03844321|182937745|SUPERIORITY||Difference in Slopes|-0.02||||0.488|TWO_SIDED|95.0|-0.06|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1560|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.03|-0.06|.488
91703208|NCT01672294|183300980|SUPERIORITY_OR_OTHER||expected change in difference in logs|0.0593||||0.8748|TWO_SIDED|95.0|-0.6784|0.797|||Standard negative binomial with offset||The expected change in the difference of the logs of expected Days in VA inpatient care or ED.|||0.797|-0.6784|0.8748
91703209|NCT01672294|183300981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01777||||0.7687|TWO_SIDED|95.0|-0.1372|0.1017||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks|Mixed Models Analysis|||"Between Outlook Intervention caregivers and active control caregivers at 5 weeks.~Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks."||0.1017|-0.1372|0.7687
91703210|NCT01672294|183300981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.00087||||0.9863|TWO_SIDED|95.0|-0.1003|0.09861||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||0.09861|-0.1003|0.9863
91703211|NCT01672294|183300982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01166||||0.9221|TWO_SIDED|95.0|-0.2475|0.2241|||Mixed Models Analysis|||At 5 weeks - Completion subscale||0.2241|-0.2475|0.9221
91703212|NCT01672294|183300982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1154||||0.3249|TWO_SIDED|95.0|-0.3466|0.1158||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.||0.1158|-0.3466|0.3249
91703213|NCT03379792|183300992|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
91703214|NCT03379792|183300992|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
91703215|NCT03379792|183300992|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
91703216|NCT00306787|183301027|NON_INFERIORITY_OR_EQUIVALENCE|The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.|Median Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.15|0.6|||Hodges-Lehman|||Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.||0.60|-0.15|
91703217|NCT00336323|183301033|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 1.25 mg injection at baseline and at 6 weeks treatment group||||0.009
91703218|NCT00336323|183301033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 2.5mg injection at baseline and 6 weeks treatment group||||<0.001
91703219|NCT00336323|183301033|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.66
91703220|NCT00336323|183301033|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.49
91703221|NCT00336323|183301033|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.45
91703222|NCT00336323|183301033|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.90
91703223|NCT00336323|183301034|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.42
91703224|NCT00336323|183301034|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.67
91703225|NCT00336323|183301034|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.48
91703226|NCT00336323|183301034|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Least squares regression|||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.82
91703227|NCT00336323|183301034|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 1.25mg injection at baseline and at 6 weeks treatment group||||0.01
91703228|NCT00336323|183301034|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 2.5mg injection at baseline and at 6 weeks treatment group||||0.003
91703229|NCT00336323|183301037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to those that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||<0.0001
91703230|NCT00336323|183301038|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Least squares regression|Adjusted for baseline score||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline visual acuity letter score that was \<65 letters compared to those that had baseline visual acuity letter score that was ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.31
91703231|NCT00336323|183301039|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between those that were ≤66 years old compared to those that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.44
91703232|NCT00336323|183301040|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.55
91703233|NCT00336323|183301041|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had no history of treatment for diabetic macular edema compared to those that had history or treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.16
91703234|NCT00336323|183301042|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline retinopathy severity that was \<severe nonproliferative diabetic retinopathy (NPDR) compared to those that had baseline retinopathy severity that was proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.53
91703235|NCT00336323|183301043|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline clinical diabetic macular edema characterized as typical/predominantly focal, neither predominantly focal or diffuse, or typical/predominantly diffuse. Eyes included all of those from the pooled Bevacizumab group.||||0.93
91703236|NCT00336323|183301044|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline subretinal fluid that was definite/questionable compared to eyes that had no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.52
91703237|NCT00336323|183301045|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to eyes that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||0.22
91703238|NCT00336323|183301046|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline visual acuity letter score of \<65 letters compared to eyes that had baseline visual acuity letter score of ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.006
91703239|NCT00336323|183301047|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that were ≤66 years old at baseline compared to eyes that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.23
91703240|NCT00336323|183301048|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.37
91703241|NCT00336323|183301049|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that did not have a prior history of treatment for diabetic macular edema compared to eyes that did have a prior history of treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.04
91703242|NCT00336323|183301050|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline retinopathy severity of \<severe nonproliferative diabetic retinopathy (NPDR) compared to eyes that had baseline retinopathy severity of proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.38
91703243|NCT00336323|183301051|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline clinical diabetic macular edema (DME) characterization of typical/predominantly focal compared to neither predominantly focal or diffuse characterization at baseline and compared to typical/predominantly diffuse characterization at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.45
91497378|NCT03978520|182865119|SUPERIORITY||Response Rate Difference|14.7|||=|0.049|TWO_SIDED|95.0|0.0|29.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||29.4|0.0|=0.049
91530816|NCT03844321|182937745|SUPERIORITY||Difference in Slopes|0.01||||0.446|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1179|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.446
91703244|NCT00336323|183301052|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline subretinal fluid presence that was definite/questionable compared to eyes that there was no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.06
91703245|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||||||P-value is for Physical Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an Analysis of Covariance (ANCOVA) for change from baseline. Covariates include: treatment and baseline value.||||||0.3375
91703246|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.516||||||P-value is for Physical Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.516
91703247|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||||||P-value is for Physical Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.786
91703248|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1496||||||P-value is for Physical Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1496
91703249|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8428||||||P-value is for Physical Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8428
91703250|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7345||||||P-value is for Physical Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7345
91703251|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928||||||P-value is for Physical Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8928
91703252|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7343||||||P-value is for Physical Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7343
91703253|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8798||||||P-value is for Social/Family Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8798
91703254|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6837||||||P-value is for Social/Family Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6837
91703255|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7226||||||P-value is for Social/Family Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7226
91703256|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||||||P-value is for Social/Family Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.641
91703257|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.478||||||P-value is for Social/Family Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.478
91703258|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||||||P-value is for Social/Family Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.9367
91703259|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5108||||||P-value is for Social/Family Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5108
91703260|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8976||||||P-value is for Social/Family Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8976
91703261|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8193||||||P-value is for Emotional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8193
91703262|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695||||||P-value is for Emotional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1695
91703263|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4021||||||P-value is for Emotional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.4021
91497379|NCT03978520|182865119|SUPERIORITY||Response Rate Difference|13.9|||=|0.091|TWO_SIDED|95.0|-2.2|30.1|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||30.1|-2.2|=0.091
91497380|NCT03978520|182865119|SUPERIORITY||Response Rate Difference|-6.3|||=|0.447|TWO_SIDED|95.0|-22.5|9.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||9.9|-22.5|=0.447
91703264|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3603||||||P-value is for Emotional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3603
91703265|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5169||||||P-value is for Emotional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5169
91703266|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1642||||||P-value is for Emotional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1642
91703267|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6354||||||P-value is for Emotional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6354
91530817|NCT03844321|182937746|SUPERIORITY||Difference in Slopes|-0.04||||0.469|TWO_SIDED|95.0|-0.16|0.07||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1618|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly FFMQ scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.07|-0.16|.469
91703268|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3517||||||P-value is for Emotional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3517
91703269|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7605||||||P-value is for Functional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7605
91703270|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747||||||P-value is for Functional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3747
91703271|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379||||||P-value is for Functional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8379
91530818|NCT03844321|182937746|SUPERIORITY||Difference in Slopes|-0.06||||0.033|TWO_SIDED|95.0|-0.11|-0.01||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1067|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used linear mixed effects models to examine the effect of time on weekly FFMQ scores across both intervention conditions from baseline to 20 weeks.||-0.01|-0.11|.033
91703272|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1179||||||P-value is for Functional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1179
91703273|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7412||||||P-value is for Functional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7412
91703274|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3773||||||P-value is for Functional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3773
91703275|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7402||||||P-value is for Functional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7402
91703276|NCT00586508|183301103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2671||||||P-value is for Functional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.2671
91703277|NCT03191864|183301202|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
91703278|NCT03191864|183301202|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91703279|NCT03191864|183301202|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91703280|NCT03191864|183301202|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91703281|NCT03191864|183301204|OTHER||Mean Difference (Final Values)|-1.28||||0.02|TWO_SIDED|90.0|-2.29|-0.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.26|-2.29|0.020
91703282|NCT03191864|183301204|OTHER||Mean Difference (Final Values)|-2.08|||<|0.001|TWO_SIDED|90.0|-3.07|-1.1|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.10|-3.07|<0.001
91703283|NCT03191864|183301204|OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|90.0|-3.23|-1.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.26|-3.23|<0.001
91703284|NCT03191864|183301204|OTHER||Mean Difference (Final Values)|-1.59||||0.005|TWO_SIDED|90.0|-2.59|-0.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.59|-2.59|0.005
91703285|NCT03191864|183301206|OTHER||Mean Difference (Final Values)|-1.19||||0.067|TWO_SIDED|90.0|-2.49|0.12|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||0.12|-2.49|0.067
91703286|NCT03191864|183301206|OTHER||Mean Difference (Final Values)|0.34||||0.672|TWO_SIDED|90.0|-0.91|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.91|0.672
91703287|NCT03191864|183301206|OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|90.0|-2.55|-0.01|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||-0.01|-2.55|0.048
91703288|NCT03191864|183301206|OTHER||Mean Difference (Final Values)|0.31||||0.653|TWO_SIDED|90.0|-0.98|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.98|0.653
91703289|NCT03191864|183301208|SUPERIORITY||Mean Difference (Final Values)|-8.81||||0.079|TWO_SIDED|90.0|-19.06|1.45|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||1.45|-19.06|0.079
91703290|NCT03191864|183301208|SUPERIORITY||Mean Difference (Final Values)|-5.18||||0.195|TWO_SIDED|90.0|-15.14|4.78|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||4.78|-15.14|0.195
91703291|NCT03191864|183301208|SUPERIORITY||Mean Difference (Final Values)|-12.56||||0.02|TWO_SIDED|90.0|-22.55|-2.58|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-2.58|-22.55|0.020
91703292|NCT03191864|183301208|SUPERIORITY||Mean Difference (Final Values)|-10.61||||0.043|TWO_SIDED|90.0|-20.74|-0.48|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-0.48|-20.74|0.043
91703293|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.459|TWO_SIDED|90.0|-3.49|3.08|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.08|-3.49|0.459
91703294|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.617|TWO_SIDED|90.0|-2.65|3.8|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.80|-2.65|0.617
91497381|NCT03978520|182865120|SUPERIORITY||Response Rate Difference|16.7|||=|0.007|TWO_SIDED|95.0|4.5|28.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||28.9|4.5|=0.007
91530819|NCT03844321|182937747|SUPERIORITY|||||||0.046||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.046
91703295|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.167|TWO_SIDED|90.0|-5.07|1.33|||ANCOVA|||VDQ Score Change from Baseline Week 12||1.33|-5.07|0.167
91703296|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.373|TWO_SIDED|90.0|-3.88|2.61|||ANCOVA|||VDQ Score Change from Baseline Week 12||2.61|-3.88|0.373
91703297|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-1.66||||0.203|TWO_SIDED|90.0|-4.96|1.64|||ANCOVA|||AMS Score Change from Baseline Week 12||1.64|-4.96|0.203
91703298|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-4.33||||0.014|TWO_SIDED|90.0|-7.54|-1.13|||ANCOVA|||AMS Score Change from Baseline Week 12||-1.13|-7.54|0.014
91703299|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-3.02||||0.061|TWO_SIDED|90.0|-6.23|0.2|||ANCOVA|||AMS Score Change from Baseline Week 12||0.20|-6.23|0.061
91703300|NCT03191864|183301209|SUPERIORITY||Mean Difference (Final Values)|-2.57||||0.097|TWO_SIDED|90.0|-5.83|0.69|||ANCOVA|||AMS Score Change from Baseline Week 12||0.69|-5.83|0.097
91703301|NCT02086682|183301223|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91703302|NCT02044874|183301224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0027|TWO_SIDED|95.0|1.47|6.22|||Regression, Logistic|||||6.22|1.47|0.0027
91703303|NCT02044874|183301224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.2427|TWO_SIDED|95.0|0.73|3.51|||Regression, Logistic|||||3.51|0.73|0.2427
91703304|NCT02044874|183301224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0477|TWO_SIDED|95.0|1.01|3.56|||Regression, Logistic|||||3.56|1.01|0.0477
91703305|NCT02044874|183301225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0784|TWO_SIDED|95.0|0.89|9.08|||Regression, Logistic|||||9.08|0.89|0.0784
91703306|NCT02044874|183301225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.365|TWO_SIDED|95.0|0.51|6.17|||Regression, Logistic|||||6.17|0.51|0.3650
91703307|NCT02044874|183301225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.3438|TWO_SIDED|95.0|0.61|4.21|||Regression, Logistic|||||4.21|0.61|0.3438
91703308|NCT02044874|183301226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0379|TWO_SIDED|95.0|1.04|3.55|||Regression, Logistic|||||3.55|1.04|0.0379
91703309|NCT02044874|183301226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8628|TWO_SIDED|95.0|0.54|2.09|||Regression, Logistic|||||2.09|0.54|0.8628
91703310|NCT02044874|183301226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0556|TWO_SIDED|95.0|0.99|3.31|||Regression, Logistic|||||3.31|0.99|0.0556
91703311|NCT02044874|183301227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0219|TWO_SIDED|95.0|1.1|3.35|||Regression, Logistic|||||3.35|1.10|0.0219
91703312|NCT02044874|183301227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.545|TWO_SIDED|95.0|0.66|2.18|||Regression, Logistic|||||2.18|0.66|0.5450
91703313|NCT02044874|183301227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0868|TWO_SIDED|95.0|0.93|2.72|||Regression, Logistic|||||2.72|0.93|0.0868
91703314|NCT02044874|183301228|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.97||||0.0004|TWO_SIDED|95.0|-1.51|-0.43|||Mixed-effects repeated measures|||||-0.43|-1.51|0.0004
91703315|NCT02044874|183301228|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.2268|TWO_SIDED|95.0|-0.89|0.21|||mixed effects repeated measures|||||0.21|-0.89|0.2268
91703316|NCT02044874|183301228|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63||||0.0217|TWO_SIDED|95.0|-1.17|-0.09|||mixed effects repeated measures|||||-0.09|-1.17|0.0217
91703317|NCT00415597|183301230|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
91703318|NCT00415597|183301231|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
91703319|NCT04231396|183301232|SUPERIORITY||Mean Difference (Final Values)|0.1456||||0.037|TWO_SIDED|95.0|0.012|0.279|||t-test, 1 sided|||The SNR Loss scores computed the means per client and week (1-12), with a smoothing method: isotonic regression (isoreg, via R). The slopes (lsfit, via R) calculated of the smoothed means separately per client, per 7-9 weeks (early training weeks), and per 10-12 weeks (final training weeks). This created slope differences, per client.||.279|.012|.037
91703320|NCT03976323|183301267|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.8721|TWO_SIDED|95.0|0.92|1.36||One-sided p-value based on log-rank test stratified by Eastern Cooperative Oncology Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.36|0.92|0.8721
91703321|NCT03976323|183301268|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6649|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.25|0.87|0.6649
91497382|NCT03978520|182865120|SUPERIORITY||Response Rate Difference|31.0|||<|0.001|TWO_SIDED|95.0|18.1|44.0|||Cochran-Mantel-Haenszel|||Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo||44.0|18.1|<0.001
91703322|NCT03976323|183301271|SUPERIORITY||Difference in Least Squares (LS) Means|-1.9||||0.2533|TWO_SIDED|95.0|-5.16|1.36||Two-sided p-value based on t test.|t-test, 2 sided||Based on constrained longitudinal data analysis model (cLDA) model with PRO scores as response variable with covariates for treatment by time interaction, stratification factors, response at randomization and baseline PD-L1 expression as covariates.|||1.36|-5.16|0.2533
91703323|NCT03976323|183301272|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8125|TWO_SIDED|95.0|0.76|1.24||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.24|0.76|0.8125
91703324|NCT03976323|183301273|SUPERIORITY||Difference in LS Means|-0.16||||0.9364|TWO_SIDED|95.0|-4.02|3.71||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.71|-4.02|0.9364
91703325|NCT03976323|183301274|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3782|TWO_SIDED|95.0|0.66|1.17||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.17|0.66|0.3782
91703326|NCT03976323|183301275|SUPERIORITY||Difference in LS Means|-0.35||||0.8285|TWO_SIDED|95.0|-3.54|2.83||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.83|-3.54|0.8285
91703327|NCT03976323|183301276|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6272|TWO_SIDED|95.0|0.78|1.51||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.51|0.78|0.6272
91703328|NCT03976323|183301277|SUPERIORITY||Difference in LS Means|-1.51||||0.4422|TWO_SIDED|95.0|-5.38|2.35||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.35|-5.38|0.4422
91497383|NCT03978520|182865120|SUPERIORITY||Response Rate Difference|-13.7|||=|0.068|TWO_SIDED|95.0|-28.4|1.0|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||1.0|-28.4|=0.068
91497384|NCT03978520|182865121|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.527|=|0.71|TWO_SIDED|95.0|-0.84|1.23|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.23|-0.84|=0.710
91497385|NCT03978520|182865121|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.545|=|0.963|TWO_SIDED|95.0|-1.05|1.1|||Mixed-effect model repeat measurement|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.10|-1.05|=0.963
91497386|NCT03978520|182865121|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.547|=|0.754|TWO_SIDED|95.0|-0.9|1.25|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.25|-0.90|=0.754
91530820|NCT03844321|182937747|SUPERIORITY|||||||0.275||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.275
91703329|NCT03976323|183301278|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9156|TWO_SIDED|95.0|0.74|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.74|0.9156
91703330|NCT03976323|183301279|SUPERIORITY||Difference in LS Means|-0.01||||0.9962|TWO_SIDED|95.0|-2.94|2.93||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.93|-2.94|0.9962
91703331|NCT03976323|183301280|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5517|TWO_SIDED|95.0|0.83|1.4||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.40|0.83|0.5517
91703332|NCT02294461|183301281|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Cox Proportional Hazards|0.38|||<|0.0001|TWO_SIDED|95.0|0.27|0.52|||Hazard Ratio|||P-value is based on an unstratified log-rank test. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.52|0.27|<0.0001
91703333|NCT02294461|183301282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.51|0.95||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had died at the analysis date were censored at date last known alive. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.95|0.51|0.0208
91703334|NCT02294461|183301283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001||95.0|0.2|0.46||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had an rPFS event were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.||0.46|0.20|<0.0001
91703335|NCT02294461|183301284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.2501|TWO_SIDED|95.0|0.21|1.52||P-value was based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not have an SRE were censored at the date of the last assessment indicating no evidence of SRE. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||1.52|0.21|0.2501
91703336|NCT02294461|183301285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.002||95.0|0.12|0.66||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not start cytotoxic chemotherapy were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.66|0.12|0.0020
91703337|NCT02294461|183301286|SUPERIORITY_OR_OTHER_LEGACY||Difference of response rate|55.8|||<|0.0001|TWO_SIDED|95.0|47.4|64.2||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel %|||||64.2|47.4|<0.0001
91703338|NCT02294461|183301287|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|26.0|||<|0.0001|TWO_SIDED|95.0|14.7|37.4||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel|||When deriving the response category, it was based on the target, non-target and new lesions without confirming CR, PR, and Progressive disease (PD). Participants with no post baseline assessment were included in the category of Nonevaluable (NE). The best overall soft tissue objective response was defined as PR or CR based on the investigator assessments of target, non-target and new lesions while on the study treatment.||37.4|14.7|<0.0001
91703339|NCT03334422|183301337|SUPERIORITY||Odds Ratio (OR)|2.58||||0.026|TWO_SIDED|95.0|1.12|5.92|||Regression, Logistic|||||5.92|1.12|0.026
91497387|NCT03978520|182865122|SUPERIORITY||Rate difference|-1.06|||=|0.002|TWO_SIDED|95.0|-1.74|-0.39|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.39|-1.74|=0.002
91703340|NCT03334422|183301337|SUPERIORITY||Odds Ratio (OR)|3.64||||0.001|TWO_SIDED|95.0|1.64|8.05|||Regression, Logistic|||||8.05|1.64|0.001
91703341|NCT03334422|183301338|SUPERIORITY||Odds Ratio (OR)|2.13||||0.085|TWO_SIDED|95.0|0.9|5.02|||Regression, Logistic|||||5.02|0.90|0.085
91703342|NCT03334422|183301339|SUPERIORITY||Odds Ratio (OR)|2.35||||0.024|TWO_SIDED|95.0|1.12|4.93|||Regression, Logistic|||||4.93|1.12|0.024
91703343|NCT03334422|183301339|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.73|7.04|||Regression, Logistic|||||7.04|1.73|<0.001
91703344|NCT03334422|183301339|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.22|8.76|||Regression, Logistic|||||8.76|2.22|<0.001
91703345|NCT03334422|183301340|SUPERIORITY||Odds Ratio (OR)|2.8||||0.053|TWO_SIDED|95.0|0.99|7.97|||Regression, Logistic|||||7.97|0.99|0.053
91497388|NCT03978520|182865122|SUPERIORITY||Rate Difference|-0.69|||=|0.059|TWO_SIDED|95.0|-1.41|0.03|||Binomial regression|||"Mild/Moderate~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.03|-1.41|=0.059
91703346|NCT03334422|183301340|SUPERIORITY||Odds Ratio (OR)|3.87||||0.007|TWO_SIDED|95.0|1.44|10.41|||Regression, Logistic|||||10.41|1.44|0.007
91703347|NCT03334422|183301340|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.42|15.91|||Regression, Logistic|||||15.91|2.42|<0.001
91703348|NCT03334422|183301341|SUPERIORITY||Mean Difference (Net)|-12.76|STANDARD_ERROR_OF_MEAN|6.81||0.062|TWO_SIDED|95.0|-26.19|0.66|||Mixed Models Analysis|||||0.66|-26.19|0.062
91703349|NCT03334422|183301341|SUPERIORITY||Mean Difference (Net)|-25.89|STANDARD_ERROR_OF_MEAN|6.54|<|0.001|TWO_SIDED|95.0|-38.78|-12.99|||Mixed Models Analysis|||||-12.99|-38.78|<0.001
91703350|NCT03334422|183301341|SUPERIORITY||Mean Difference (Net)|-25.97|STANDARD_ERROR_OF_MEAN|6.24|<|0.001|TWO_SIDED|95.0|-38.29|-13.65|||Mixed Models Analysis|||||-13.65|-38.29|<0.001
91703351|NCT03334422|183301342|SUPERIORITY||Odds Ratio (OR)|2.9||||0.086|TWO_SIDED|95.0|0.86|9.76|||Regression, Logistic|||||9.76|0.86|0.086
91703352|NCT03334422|183301342|SUPERIORITY||Odds Ratio (OR)|4.95||||0.006|TWO_SIDED|95.0|1.58|15.49|||Regression, Logistic|||||15.49|1.58|0.006
91497389|NCT03978520|182865122|SUPERIORITY||Rate Difference|-0.37|||=|0.252|TWO_SIDED|95.0|-1.01|0.27|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.27|-1.01|=0.252
91497390|NCT03978520|182865122|SUPERIORITY||Rate Difference|-0.1|||=|0.467|TWO_SIDED|95.0|-0.37|0.17|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.17|-0.37|=0.467
91703353|NCT03334422|183301342|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.001|TWO_SIDED|95.0|2.51|21.83|||Regression, Logistic|||||21.83|2.51|<0.001
91703354|NCT03334422|183301343|SUPERIORITY||Odds Ratio (OR)|1.41||||0.505|TWO_SIDED|95.0|0.51|3.87|||Regression, Logistic|||||3.87|0.51|0.505
91703355|NCT03334422|183301343|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.27|||Regression, Logistic|||||8.27|1.60|0.002
91497391|NCT03978520|182865122|SUPERIORITY||Rate Difference|-0.26|||=|0.033|TWO_SIDED|95.0|-0.49|-0.02|||Binomial regression|||"Severe~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.02|-0.49|=0.033
91497392|NCT03978520|182865122|SUPERIORITY||Rate Difference|0.15|||=|0.156|TWO_SIDED|95.0|-0.06|0.37|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.37|-0.06|=0.156
91497393|NCT03978520|182865122|SUPERIORITY||Rate Difference|-1.16|||=|0.002|TWO_SIDED|95.0|-1.89|-0.44|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.44|-1.89|=0.002
91530821|NCT03844321|182937748|SUPERIORITY|||||||0.977||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.977
91703356|NCT03334422|183301343|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.22|10.86|||Regression, Logistic|||||10.86|2.22|<0.001
91703357|NCT03334422|183301344|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.074|TWO_SIDED|95.0|-0.57|0.03|||Mixed Models Analysis|||||0.03|-0.57|0.074
91703358|NCT03334422|183301344|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||||-0.09|-0.68|0.011
91703359|NCT03334422|183301344|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.26|||Mixed Models Analysis|||||-0.26|-0.84|<0.001
91703360|NCT03334422|183301345|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-1.05|0.59|||Mixed Models Analysis|||||0.59|-1.05|0.580
91703361|NCT03334422|183301345|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.54|-0.96|||Mixed Models Analysis|||||-0.96|-2.54|<0.001
91703362|NCT03334422|183301345|SUPERIORITY||Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.37|-0.87|||Mixed Models Analysis|||||-0.87|-2.37|<0.001
91703363|NCT03334422|183301346|SUPERIORITY||Odds Ratio (OR)|1.67||||0.094|TWO_SIDED|95.0|0.92|3.04|||Regression, Logistic|||||3.04|0.92|0.094
91703364|NCT03334422|183301346|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.65|5.11|||Regression, Logistic|||||5.11|1.65|<0.001
91703365|NCT03334422|183301346|SUPERIORITY||Odds Ratio (OR)|3.15|||<|0.001|TWO_SIDED|95.0|1.8|5.51|||Regression, Logistic|||||5.51|1.80|<0.001
91703366|NCT03334422|183301347|SUPERIORITY||Odds Ratio (OR)|1.57||||0.528|TWO_SIDED|95.0|0.39|6.31|||Regression, Logistic|||||6.31|0.39|0.528
91703367|NCT03334422|183301347|SUPERIORITY||Odds Ratio (OR)|2.56||||0.142|TWO_SIDED|95.0|0.73|8.95|||Regression, Logistic|||||8.95|0.73|0.142
91703368|NCT03334422|183301347|SUPERIORITY||Odds Ratio (OR)|2.68||||0.123|TWO_SIDED|95.0|0.77|9.37|||Regression, Logistic|||||9.37|0.77|0.123
91703369|NCT03334422|183301348|SUPERIORITY||LSMean Difference|-6.88|STANDARD_ERROR_OF_MEAN|3.63||0.059|TWO_SIDED|95.0|-14.03|0.28|||Mixed Models Analysis|||||0.28|-14.03|0.059
91703370|NCT03334422|183301348|SUPERIORITY||LSMean Difference|-14.48|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-21.32|-7.63|||Mixed Models Analysis|||||-7.63|-21.32|<0.001
91703371|NCT03334422|183301348|SUPERIORITY||LSMean Difference|-14.15|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-20.69|-7.61|||Mixed Models Analysis|||||-7.61|-20.69|<0.001
91703372|NCT03334422|183301349|SUPERIORITY||Odds Ratio (OR)|2.55||||0.193|TWO_SIDED|95.0|0.62|10.45|||Regression, Logistic|||||10.45|0.62|0.193
91703373|NCT03334422|183301349|SUPERIORITY||Odds Ratio (OR)|4.1||||0.042|TWO_SIDED|95.0|1.05|16.03|||Mixed Models Analysis|||||16.03|1.05|0.042
91703374|NCT03334422|183301349|SUPERIORITY||Odds Ratio (OR)|3.89||||0.044|TWO_SIDED|95.0|1.04|14.57|||Regression, Logistic|||||14.57|1.04|0.044
91703375|NCT03334422|183301350|SUPERIORITY||LSMean Difference|-6.16|STANDARD_ERROR_OF_MEAN|3.23||0.058|TWO_SIDED|95.0|-12.53|0.21|||Mixed Models Analysis|||||0.21|-12.53|0.058
91703376|NCT03334422|183301350|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|95.0|-15.42|-3.18|||Mixed Models Analysis|||||-3.18|-15.42|0.003
91703377|NCT03334422|183301350|SUPERIORITY||LSMean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-17.03|-5.3|||Mixed Models Analysis|||||-5.30|-17.03|<0.001
91703378|NCT03334422|183301351|SUPERIORITY|||||||0.189|||||||Fisher Exact|||||||0.189
91703379|NCT03334422|183301351|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91497394|NCT03978520|182865122|SUPERIORITY||Rate Difference|-0.95|||=|0.014|TWO_SIDED|95.0|-1.7|-0.19|||Binomial regression|||"Overall~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.19|-1.70|=0.014
91497395|NCT03978520|182865122|SUPERIORITY||Rate Difference|-0.22|||=|0.526|TWO_SIDED|95.0|-0.89|0.46|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.46|-0.89|=0.526
91497396|NCT02421315|182865157|OTHER|a t-test comparing groups in a specific region-of-interest (ROI); the insula|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.057||0.0585|TWO_SIDED|95.0|-0.004|0.224|||t-test, 2 sided|||We hypothesized that compared to HC, children and adolescents with OCD would have increased activation in subcortical structures (insula, and putamen) comprising a right hemisphere dorsal frontostriatal circuit.||0.224|-0.004|0.0585
91530822|NCT03844321|182937748|SUPERIORITY|||||||0.341||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.341
91497397|NCT02421315|182865158|SUPERIORITY|We selected 'arbitrary units' as the unit of measure here because we are looking at connectivity strengths|Mean Difference (Final Values)|0.49512921|STANDARD_ERROR_OF_MEAN|0.06553315||0.037|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p\<.05 with 20,000 permutations was used."|t-test, 1 sided||Direction of the comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the FC-strength indices between 352 regions. Edge-wise functional connectivity analyses was then be conducted across the resulting matrix comprised of 352 nodes and 123,904 edges, using the Network-Based Statistics (NBS) Toolbox. We hypothesized that youth with OCD would show altered FC between task-control circuit regions.||||.037
91497398|NCT02421315|182865158|OTHER||Slope|-0.521|||<|0.05|TWO_SIDED||||||Regression, Linear|||Separate cross-lagged panel models were computed in the OCD group for the three functional connections that differed significantly across groups at baseline (see Statistical Analysis 1). These models were constructed using IBM SPSS Amos (v.23) to test for directional relationships between OCD symptoms and FC pre- to post-treatment in the OCD patients. CY-BOCS total scores at each time point were used as the OCD symptoms measure.||||<.05
91497399|NCT02421315|182865159|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0464|TWO_SIDED|95.0|0.0018|0.218|||t-test, 2 sided|||||0.218|0.0018|0.0464
91703380|NCT03334422|183301351|SUPERIORITY|||||||0.383|||||||Fisher Exact|||||||0.383
91703381|NCT03334422|183301352|SUPERIORITY||LSMean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.46||0.081|TWO_SIDED|95.0|-31.45|1.85|||Mixed Models Analysis|||||1.85|-31.45|0.081
91703382|NCT03334422|183301352|SUPERIORITY||LSMean Difference|-30.66|STANDARD_ERROR_OF_MEAN|8.11|<|0.001|TWO_SIDED|95.0|-46.62|-14.7|||Mixed Models Analysis|||||-14.70|-46.62|<0.001
91703383|NCT03334422|183301352|SUPERIORITY||LSMean Difference|-30.28|STANDARD_ERROR_OF_MEAN|7.63|<|0.001|TWO_SIDED|95.0|-45.29|-15.27|||Mixed Models Analysis|||||-15.27|-45.29|<0.001
91703384|NCT03334422|183301353|SUPERIORITY||LSMean Difference|-2.36|STANDARD_ERROR_OF_MEAN|1.32||0.075|TWO_SIDED|95.0|-4.97|0.24|||Mixed Models Analysis|||||0.24|-4.97|0.075
91703385|NCT03334422|183301353|SUPERIORITY||LSMean Difference|-5.58|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-8.07|-3.08|||Mixed Models Analysis|||||-3.08|-8.07|<0.001
91703386|NCT03334422|183301353|SUPERIORITY||LSMean Difference|-6.07|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.47|-3.68|||Mixed Models Analysis|||||-3.68|-8.47|<0.001
91703387|NCT03334422|183301354|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.13|TWO_SIDED|95.0|-0.61|0.08|||Mixed Models Analysis|||||0.08|-0.61|0.130
91703388|NCT03334422|183301354|SUPERIORITY||LSMean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.28|||Mixed Models Analysis|||||-0.28|-0.94|<0.001
91703389|NCT03334422|183301354|SUPERIORITY||LSMean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.0|-0.38|||Mixed Models Analysis|||||-0.38|-1.00|<0.001
91703390|NCT03334422|183301355|SUPERIORITY||LSMean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.51||0.067|TWO_SIDED|95.0|-1.95|0.07|||Mixed Models Analysis|||HADS Anxiety.||0.07|-1.95|0.067
91703391|NCT03334422|183301355|SUPERIORITY||LSMean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.06|TWO_SIDED|95.0|-1.89|0.04|||Mixed Models Analysis|||HADS Anxiety.||0.04|-1.89|0.060
91703392|NCT03334422|183301355|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.47||0.006|TWO_SIDED|95.0|-2.23|-0.38|||Mixed Models Analysis|||HADS Anxiety.||-0.38|-2.23|0.006
91703393|NCT03334422|183301355|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.321|TWO_SIDED|95.0|-1.5|0.49|||Mixed Models Analysis|||HADS Depression.||0.49|-1.50|0.321
91703394|NCT03334422|183301355|SUPERIORITY||LSMean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|95.0|-1.67|0.24|||Mixed Models Analysis|||HADS Depression.||0.24|-1.67|0.143
91736320|NCT03189719|183365725|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Stratified Log-Rank|||OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.78|0.49|<0.0001
91703395|NCT03334422|183301355|SUPERIORITY||LSMean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.47||0.012|TWO_SIDED|95.0|-2.11|-0.26|||Mixed Models Analysis|||HADS Depression.||-0.26|-2.11|0.012
91703396|NCT03334422|183301356|SUPERIORITY||LSMean Difference|-1.76|STANDARD_ERROR_OF_MEAN|0.97||0.071|TWO_SIDED|95.0|-3.67|0.15|||Mixed Models Analysis|||||0.15|-3.67|0.071
91703397|NCT03334422|183301356|SUPERIORITY||LSMean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.92|-2.26|||Mixed Models Analysis|||||-2.26|-5.92|<0.001
91703398|NCT03334422|183301356|SUPERIORITY||LSMean Difference|-4.22|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.98|-2.45|||Mixed Models Analysis|||||-2.45|-5.98|<0.001
91703399|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|5.17||0.861|TWO_SIDED|95.0|-11.16|9.34|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||9.34|-11.16|0.861
91703400|NCT03334422|183301357|SUPERIORITY||LSMean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.03||0.841|TWO_SIDED|95.0|-8.94|10.97||Absenteeism|Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||10.97|-8.94|0.841
91703401|NCT03334422|183301357|SUPERIORITY||LSMean Difference|5.16|STANDARD_ERROR_OF_MEAN|4.6||0.264|TWO_SIDED|95.0|-3.95|14.26|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||14.26|-3.95|0.264
91703402|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|5.63||0.58|TWO_SIDED|95.0|-14.26|8.02|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||8.02|-14.26|0.580
91703403|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|5.5||0.015|TWO_SIDED|95.0|-24.45|-2.86|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-2.86|-24.45|0.015
91703404|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-13.13|STANDARD_ERROR_OF_MEAN|5.08||0.011|TWO_SIDED|95.0|-23.2|-3.06|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-3.06|-23.20|0.011
91703405|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-1.81|STANDARD_ERROR_OF_MEAN|6.71||0.788|TWO_SIDED|95.0|-15.12|11.49|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||11.49|-15.12|0.788
91703406|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-9.48|STANDARD_ERROR_OF_MEAN|6.57||0.152|TWO_SIDED|95.0|-22.51|3.55|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||3.55|-22.51|0.152
91703407|NCT03334422|183301357|SUPERIORITY|Overall Work Impairment|LSMean Difference|-9.13|STANDARD_ERROR_OF_MEAN|6.07||0.135|TWO_SIDED|95.0|-21.17|2.9|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.90|-21.17|0.135
91703408|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-2.26|STANDARD_ERROR_OF_MEAN|4.25||0.595|TWO_SIDED|95.0|-10.65|6.12|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||6.12|-10.65|0.595
91703409|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-22.43|-6.17|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.17|-22.43|<0.001
91703410|NCT03334422|183301357|SUPERIORITY||LSMean Difference|-14.47|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-22.11|-6.83|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.83|-22.11|<0.001
91497400|NCT02421315|182865160|SUPERIORITY|only participants were assigned to groups (OCD, HC) and we measured streamline count in these participants to index structural connectivity|Slope|-102.67|||<|0.025|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p=.025 with 10,000 permutations was used."|Regression, Linear||Direction of comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the structural connectivity indices (streamline count) between 164 regions. Edge-wise structural connectivity analyses was then be conducted across the resulting matrix comprised of 164 nodes and 26,896 edges, using the Network-Based Statistics (NBS) Toolbox.||||<0.025
91497401|NCT01405456|182865235|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months||||0.71
91703411|NCT03334422|183301358|SUPERIORITY||LSMean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.295|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.07|-0.02|0.295
91497402|NCT01405456|182865236|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months||||0.42
91497403|NCT01405456|182865237|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.51
91703412|NCT03334422|183301358|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|0.001
91497404|NCT01405456|182865238|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.04
91497405|NCT01405456|182865239|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months||||0.44
91497406|NCT01405456|182865240|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Mean serum measurements of Potassium||||0.07
91497407|NCT01405456|182865241|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change in Hemoglobin A1c from baseline to 6 months||||0.70
91497408|NCT01405456|182865242|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in C-Reactive Protein from baseline to 6 months||||0.10
91703413|NCT03334422|183301358|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|<0.001
91736321|NCT03189719|183365726|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.62|0.86|||Stratified Log-Rank|||OS in all participants of the pembrolizumab + SOC arm was compared to OS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.86|0.62|<0.0001
91736322|NCT03189719|183365727|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.78|||Stratified Log-Rank|||PFS in ESCC participants of the pembrolizumab + SOC arm was compared to PFS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.78|0.54|<0.0001
91736323|NCT03189719|183365728|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.65|||Stratified Log-Rank|||PFS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to PFS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.65|0.41|<0.0001
91497409|NCT01405456|182865243|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months||||0.37
91497410|NCT01405456|182865244|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change in Adiponectin from baseline to 6 months||||0.78
91497411|NCT01405456|182865245|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in IL-6 from baseline to 6 months||||0.10
91703414|NCT03334422|183301358|SUPERIORITY||LSMean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.334|TWO_SIDED|95.0|-0.03|0.1|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.10|-0.03|0.334
91497412|NCT01405456|182865246|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Change in MCP-1 from baseline to 6 months||||0.04
91497413|NCT02044393|182865257|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.07|STANDARD_ERROR_OF_MEAN|32.1|||TWO_SIDED|90.0|62.371|87.959|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 69175 treatment (in plasma)||87.959|62.371|
91497414|NCT02044393|182865257|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|86.35|STANDARD_ERROR_OF_MEAN|18.6|||TWO_SIDED|90.0|78.04|95.56|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||95.56|78.04|
91703415|NCT03334422|183301358|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|0.04|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.04|0.001
91703416|NCT03334422|183301358|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.05|<0.001
91703417|NCT03334422|183301359|SUPERIORITY||LSMean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.47||0.907|TWO_SIDED|95.0|-6.44|7.25|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.25|-6.44|0.907
91497415|NCT02044393|182865258|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|95.59|STANDARD_ERROR_OF_MEAN|23.5|||TWO_SIDED|90.0|84.195|108.537|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in plasma)||108.537|84.195|
91497416|NCT02044393|182865258|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|93.54|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|86.142|101.57|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in whole blood)||101.570|86.142|
91497417|NCT02044393|182865259|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.86|STANDARD_ERROR_OF_MEAN|32.4|||TWO_SIDED|90.0|62.946|89.035|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in plasma)||89.035|62.946|
91530823|NCT03844321|182937749|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.885
91703418|NCT03334422|183301359|SUPERIORITY||LSMean Difference|8.19|STANDARD_ERROR_OF_MEAN|3.33||0.015|TWO_SIDED|95.0|1.63|14.76|||Mixed Models Analysis|||EQ-5D-5L VAS Score||14.76|1.63|0.015
91703419|NCT03334422|183301359|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|3.14||0.006|TWO_SIDED|95.0|2.62|15.01|||Mixed Models Analysis|||EQ-5D-5L VAS Score||15.01|2.62|0.006
91703420|NCT03334422|183301360|SUPERIORITY||Odds Ratio (OR)|0.93||||0.905|TWO_SIDED|95.0|0.3|2.93|||Regression, Logistic|||||2.93|0.30|0.905
91703421|NCT03334422|183301360|SUPERIORITY||Odds Ratio (OR)|2.37||||0.064|TWO_SIDED|95.0|0.95|5.92|||Regression, Logistic|||||5.92|0.95|0.064
91703422|NCT03334422|183301360|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.25|11.74|||Regression, Logistic|||||11.74|2.25|<0.001
91703423|NCT01313221|183301361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-3.5|35.82|||||Adjusted for treatment in a mixed model|||35.82|-3.50|
91703424|NCT01313221|183301362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.23|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-5.13|27.6||||||Difference in change from Week 12 to Week 16||27.60|-5.13|
91703425|NCT01313221|183301362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.56|STANDARD_ERROR_OF_MEAN|9.53|||TWO_SIDED|95.0|-2.21|35.32||||||Difference in change from Week 12 to Week 20||35.32|-2.21|
91497418|NCT02044393|182865259|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|88.19|STANDARD_ERROR_OF_MEAN|20.7|||TWO_SIDED|90.0|78.6|98.95|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||98.95|78.60|
91497419|NCT02692716|182865268|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|< 0.0001
91497420|NCT02692716|182865268|SUPERIORITY|This hypothesis was controlled for multiplicity.|Hazard Ratio (HR)|0.79|||=|0.1749|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value from test of no difference from 1 (superiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|= 0.1749
91497421|NCT02692716|182865269|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.82|||=|0.1827|TWO_SIDED|95.0|0.61|1.1||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.10|0.61|= 0.1827
91703426|NCT03246061|183301391|SUPERIORITY||||||<|0.001||||||Interim Analysis p-value for significance of \<0.025 for an overall alpha of 0.05|ANCOVA|||Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.||||<0.001
91703427|NCT03246061|183301392|SUPERIORITY||||||<|0.001||||||Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.|ANCOVA|||||||<0.001
91703428|NCT03282591|183301413|SUPERIORITY||Mean Difference (Final Values)|31.4||||0.9942|ONE_SIDED|95.0||56.9|||Mixed Models Analysis|||||56.9||0.9942
91703429|NCT01716520|183301489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.085|0.157||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.157|0.085|<0.001
91703430|NCT01716520|183301489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||<|0.001|TWO_SIDED|95.0|0.1|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.100|<0.001
91703431|NCT01716520|183301489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.11|0.174||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.174|0.110|<0.001
91703432|NCT01716520|183301489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.067|0.13||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.130|0.067|<0.001
91703433|NCT01716520|183301489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052||||0.047|TWO_SIDED|95.0|0.001|0.104||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.104|0.001|0.047
91497422|NCT02692716|182865270|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.49|||=|0.0261|TWO_SIDED|95.0|0.27|0.92||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.92|0.27|= 0.0261
91703434|NCT01716520|183301489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.006|TWO_SIDED|95.0|0.021|0.124||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.124|0.021|0.006
91703435|NCT02635009|183301496|SUPERIORITY|||||||0.28|||||||Fisher Exact|one-sided significance level = 0.05||Proportion of participants with deterioration in HVLT-R delayed recall score at six months: Null hypothesis = No difference between the arms; Alternative hypothesis = Arm 2 will have less deterioration than Arm 1. Ninety-eight evaluable participants per arm at six months provides 80% statistical power to detect a 14.5% absolute difference between the arms in proportion of participants with deterioration at six months using a one-sided Fisher's exact test.||||0.28
91703436|NCT02635009|183301497|NON_INFERIORITY|Null hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 \> 20%; Alternative hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 = 4.5%. Using a non-inferiority margin of 20% and an assumed difference in proportions of 4.5% under the alternative, a 2-sample test of difference in proportions with a 1-sided alpha of 0.1 requires 164 patients to achieve 85% statistical power. (Statistically significant p-value indicates non-inferiority.)||||||0.003|||||||Test of binomial proportions|||||||0.0030
91703437|NCT02635009|183301498|SUPERIORITY|||||||0.0598|||||||Gray's test|||||||0.0598
91703438|NCT02635009|183301499|SUPERIORITY|||||||0.78|||||||Chi-squared|||3 months||||0.78
91703439|NCT02635009|183301499|SUPERIORITY|||||||0.63|||||||Chi-squared|||6 months||||0.63
91703440|NCT02635009|183301499|SUPERIORITY|||||||0.84|||||||Chi-squared|||12 months||||0.84
91703441|NCT02635009|183301501|SUPERIORITY|||||||0.56|||||||Chi-squared|||3 months||||0.56
91703442|NCT02635009|183301501|SUPERIORITY|||||||0.75|||||||Chi-squared|||12 months||||0.75
91703443|NCT02635009|183301503|SUPERIORITY|||||||0.81|||||||Chi-squared|||3 months||||0.81
91703444|NCT02635009|183301503|SUPERIORITY|||||||0.93|||||||Chi-squared|||6 months||||0.93
91703445|NCT02635009|183301503|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
91703446|NCT02635009|183301505|SUPERIORITY|||||||0.54|||||||Chi-squared|||3 months||||0.54
91703447|NCT02635009|183301505|SUPERIORITY|||||||0.43|||||||Chi-squared|||6 months||||0.43
91703448|NCT02635009|183301505|SUPERIORITY|||||||0.25|||||||Chi-squared|||12 months||||0.25
91703449|NCT02635009|183301507|SUPERIORITY|||||||0.71|||||||Chi-squared|||3 months||||0.71
91703450|NCT02635009|183301507|SUPERIORITY|||||||0.079|||||||Chi-squared|||6 months||||0.079
91703451|NCT02635009|183301507|SUPERIORITY|||||||0.85|||||||Chi-squared|||12 months||||0.85
91703452|NCT02635009|183301509|SUPERIORITY|||||||0.043|||||||Chi-squared|||3 months||||0.043
91703453|NCT02635009|183301509|SUPERIORITY|||||||0.017|||||||Fisher Exact|||6 months||||0.017
91703454|NCT02635009|183301509|SUPERIORITY|||||||0.057|||||||Chi-squared|||12-month||||0.057
91703455|NCT02635009|183301512|SUPERIORITY|||||||0.1|||||||Chi-squared|||3 months||||0.10
91703456|NCT02635009|183301512|SUPERIORITY|||||||0.33|||||||Chi-squared|||6 months||||0.33
91703457|NCT02635009|183301512|SUPERIORITY|||||||0.29|||||||Chi-squared|||12 months||||0.29
91703458|NCT02635009|183301514|SUPERIORITY|||||||0.0021|||||||Chi-squared|||3 months||||0.0021
91703459|NCT02635009|183301514|SUPERIORITY|||||||0.007|||||||Chi-squared|||6 months||||0.0070
91703460|NCT02635009|183301514|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
91703461|NCT02635009|183301516|SUPERIORITY|||||||0.55|||||||Chi-squared|||3 months||||0.55
91703462|NCT02635009|183301516|SUPERIORITY|||||||0.062|||||||Chi-squared|||6 months||||0.062
91703463|NCT02635009|183301516|SUPERIORITY|||||||0.32|||||||Chi-squared|||12 months||||0.32
91703464|NCT02635009|183301518|SUPERIORITY|||||||0.7|||||||Chi-squared|||3 months||||0.70
91703465|NCT02635009|183301518|SUPERIORITY|||||||0.52|||||||Chi-squared|||6 months||||0.52
91703466|NCT02635009|183301518|SUPERIORITY|||||||0.73|||||||Chi-squared|||12 months||||0.73
91703467|NCT02635009|183301520|SUPERIORITY|||||||0.28|||||||Chi-squared|||3 months||||0.28
91703468|NCT02635009|183301520|SUPERIORITY|||||||0.094|||||||Chi-squared|||6 months||||0.094
91703469|NCT02635009|183301520|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
91703470|NCT02635009|183301522|SUPERIORITY|||||||0.16|||||||Chi-squared|||3 months.||||0.16
91703471|NCT02635009|183301522|SUPERIORITY|||||||0.017|||||||Chi-squared|||6 months. Assuming 50% of patients experience deterioration at 6 months, based on a prior study (RTOG-0212), a sample size of 198 participants per arm provides 94% power to detect a 50% relative reduction (50% on Arm 1 vs. 25% on Arm 2) in decline at 6 months using Fisher's exact test with a two-sided alpha=0.05.||||0.017
91703472|NCT02635009|183301522|SUPERIORITY|||||||0.56|||||||Chi-squared|||12-month||||0.56
91703473|NCT02635009|183301524|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
91703474|NCT02635009|183301524|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
91703475|NCT02635009|183301524|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
91703476|NCT02635009|183301526|SUPERIORITY|||||||0.35|||||||Chi-squared|||3 months||||0.35
91703477|NCT02635009|183301526|SUPERIORITY|||||||0.99|||||||Chi-squared|||6 months||||0.99
91703478|NCT02635009|183301526|SUPERIORITY|||||||0.94|||||||Chi-squared|||12 months||||0.94
91703479|NCT02635009|183301530|SUPERIORITY|||||||0.79||||||Two-side significance level = 0.05|Log Rank|||||||0.79
91703480|NCT02635009|183301531|SUPERIORITY|||||||0.93|||||||Gray's test|||||||0.93
91703481|NCT04105010|183301546|SUPERIORITY||||||<|0.0001|||||||Binomial test against a null|||||||<0.0001
91703482|NCT01211483|183301561|SUPERIORITY||Hazard Ratio (HR)|0.978|||||TWO_SIDED|95.0|0.674|1.42||||||||1.420|0.674|
91703483|NCT01211483|183301561|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.523|1.131||||||||1.131|0.523|
91703484|NCT01211483|183301562|SUPERIORITY||Hazard Ratio (HR)|0.369||||0.0185|TWO_SIDED|95.0|0.161|0.846|||Cox proportional hazard|||||0.846|0.161|0.0185
91703485|NCT01211483|183301562|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.0034|TWO_SIDED|95.0|0.125|0.663|||Cox proportional hazard|||||0.663|0.125|0.0034
91703486|NCT01211483|183301563|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.9879|TWO_SIDED|95.0|0.458|2.212|||Cox proportional hazard|||||2.212|0.458|0.9879
91703487|NCT01211483|183301563|SUPERIORITY||Hazard Ratio (HR)|1.222||||0.6276|TWO_SIDED|95.0|0.544|2.746|||Cox proportional hazard|||||2.746|0.544|0.6276
91703488|NCT00676572|183301591|SUPERIORITY||||||<|0.05||||||calculated p values|t-test, 2 sided|||||||<0.05
91497423|NCT02692716|182865270|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.18|||=|0.5044|TWO_SIDED|95.0|0.73|1.9||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.90|0.73|= 0.5044
91703489|NCT00006305|183301593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.005||||0.97|TWO_SIDED|95.0|-0.031|0.02||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Revascularization compared with Medical therapy|||0.020|-0.031|0.97
91703490|NCT00006305|183301593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.89|TWO_SIDED|95.0|-0.029|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.022|-0.029|0.89
91703491|NCT00006305|183301594|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.013||||0.7|TWO_SIDED|95.0|-0.049|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Revascularization compared with Medical Therapy|||0.022|-0.049|0.70
91703492|NCT00006305|183301594|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.024||||0.13||95.0|-0.06|0.012||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.012|-0.060|0.13
91703493|NCT02470403|183301603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|80.0|-6.52|-4.87|||Mixed Models Analysis|||"This analysis included all subjects. The following criteria were assessed:~1. upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-4.87|-6.52|<0.001
91703494|NCT02470403|183301603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|||<|0.001|TWO_SIDED|80.0|-7.96|-5.73|||Mixed Models Analysis|||"This analysis included dysglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-5.73|-7.96|<0.001
91703495|NCT02470403|183301603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.55|||<|0.001|TWO_SIDED|80.0|-5.76|-3.34|||Mixed Models Analysis|||"This analysis included normoglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-3.34|-5.76|<0.001
91703496|NCT02470403|183301605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.83|||<|0.001|TWO_SIDED|80.0|-2.16|-1.51|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.51|-2.16|<0.001
91703497|NCT02470403|183301605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|||<|0.001|TWO_SIDED|80.0|-2.94|-1.84|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.84|-2.94|<0.001
91703498|NCT02470403|183301605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.38|||<|0.001|TWO_SIDED|80.0|-2.93|-1.83|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%"||-1.83|-2.93|<0.001
91497424|NCT02692716|182865270|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.74|||=|0.435|TWO_SIDED|95.0|0.35|1.57||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.57|0.35|= 0.4350
91703499|NCT02631070|183301620|SUPERIORITY||Common Risk Difference on Response Rate|24.56|||<|0.0001|TWO_SIDED|95.0|14.48|34.64|||Cochran-Mantel-Haenszel|||||34.64|14.48|<0.0001
91703500|NCT02631070|183301620|SUPERIORITY||Odds Ratio (OR)|5.065|||<|0.0001|TWO_SIDED|95.0|2.278|11.259|||Cochran-Mantel-Haenszel|||||11.259|2.278|<0.0001
91703501|NCT02631070|183301621|SUPERIORITY||Common Risk Difference on Response Rate|20.0||||0.0002|TWO_SIDED|95.0|10.92|29.08|||Cochran-Mantel-Haenszel|||||29.08|10.92|0.0002
91703502|NCT02631070|183301621|SUPERIORITY||Odds Ratio (OR)|5.071||||0.0002|TWO_SIDED|95.0|2.002|12.844|||Cochran-Mantel-Haenszel|||||12.844|2.002|0.0002
91703503|NCT02631070|183301622|SUPERIORITY||Common Risk Difference on Response Rate|21.37||||0.0003|TWO_SIDED|95.0|11.23|31.51|||Cochran-Mantel-Haenszel|||||31.51|11.23|0.0003
91703504|NCT02631070|183301622|SUPERIORITY||Odds Ratio (OR)|4.045||||0.0003|TWO_SIDED|95.0|1.827|8.956|||Cochran-Mantel-Haenszel|||||8.956|1.827|0.0003
91703505|NCT02631070|183301623|SUPERIORITY||Common Risk Difference on Response Rate|29.55|||<|0.0001|TWO_SIDED|95.0|18.73|40.36|||Cochran-Mantel-Haenszel|||||40.36|18.73|<0.0001
91703506|NCT02631070|183301623|SUPERIORITY||Odds Ratio (OR)|5.306|||<|0.0001|TWO_SIDED|95.0|2.526|11.146|||Cochran-Mantel-Haenszel|||||11.146|2.526|<0.0001
91703507|NCT02631070|183301625|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||<0.0001
91703508|NCT02631070|183301625|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||<0.0001
91703509|NCT02631070|183301626|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 24||||<0.0001
91703510|NCT02631070|183301626|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 48||||<0.0001
91703511|NCT02631070|183301627|SUPERIORITY||Hazard Ratio (HR)|0.446||||0.0445|TWO_SIDED|95.0|0.196|1.013|||Log Rank||HR is from the Cox proportional hazards model|||1.013|0.196|0.0445
91703512|NCT02631070|183301628|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.5121|TWO_SIDED|95.0|0.362|1.699|||Log Rank||HR is from the Cox proportional hazards model|||1.699|0.362|0.5121
91703513|NCT02631070|183301630|SUPERIORITY|||||||0.2382|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.2382
91703514|NCT02631070|183301630|SUPERIORITY|||||||0.5127|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.5127
91703515|NCT02631070|183301631|SUPERIORITY|||||||0.5479|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.5479
91703516|NCT02631070|183301631|SUPERIORITY|||||||0.298|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.2980
91703517|NCT02631070|183301632|SUPERIORITY||LS Mean Difference|-229.1|STANDARD_ERROR_OF_MEAN|74.43||0.0024|TWO_SIDED|95.0|-375.8|-82.4|||ANCOVA|||Week 9 Through 24||-82.4|-375.8|0.0024
91703518|NCT02631070|183301632|SUPERIORITY||LS Mean Difference|-319.5|STANDARD_ERROR_OF_MEAN|144.57||0.0294|TWO_SIDED|95.0|-606.3|-32.7|||ANCOVA|||Week 33 Through 48||-32.7|-606.3|0.0294
91703519|NCT02631070|183301633|SUPERIORITY||LS Mean Difference|-41.0|STANDARD_ERROR_OF_MEAN|40.18||0.3087|TWO_SIDED|95.0|-120.3|38.2|||ANCOVA|||Weeks 9 Through 24||38.2|-120.3|0.3087
91703520|NCT02631070|183301633|SUPERIORITY||LS Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|93.42||0.7903|TWO_SIDED|95.0|-210.7|160.8|||ANCOVA|||Weeks 33 Through 48||160.8|-210.7|0.7903
91703521|NCT02631070|183301638|SUPERIORITY||Hazard Ratio (HR)|0.986||||0.958|TWO_SIDED|95.0|0.595|1.636|||Log Rank||HR is from the Cox proportional hazards model|||1.636|0.595|0.9580
91703522|NCT01430624|183301667|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df 2, 109||||||.24
91703523|NCT01430624|183301668|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df = 2, 111||||||.89
91703524|NCT01430624|183301669|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.01
91703525|NCT01430624|183301669|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||3 month comparison|ANOVA|||||||.48
91703526|NCT01430624|183301669|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||6 month comparison|ANOVA|||||||.17
91703527|NCT01430624|183301670|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||6 week comparison|Chi-squared|df = 2, 154||||||.37
91703528|NCT01430624|183301670|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||3 month comparison|Chi-squared|df = 2, 135||||||.15
91703529|NCT01430624|183301670|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||6 month comparison|Chi-squared|df = 2, 121||||||.87
91703530|NCT01430624|183301671|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.63
91703531|NCT01430624|183301671|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.25
91703532|NCT01430624|183301671|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.59
91703533|NCT01430624|183301672|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.83
91703534|NCT01430624|183301672|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.29
91703535|NCT01430624|183301672|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.13
91703536|NCT01430624|183301673|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.012
91703537|NCT01430624|183301673|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.31
91703538|NCT01430624|183301673|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||6 month comparison|ANOVA|df = 2,116||||||.35
91703539|NCT01430624|183301674|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 141||||||.15
91703540|NCT01430624|183301674|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 127||||||.67
91703541|NCT01430624|183301674|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 110||||||.40
91703542|NCT01606202|183301692|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.708|TWO_SIDED|95.0|-0.51|0.35|||ANCOVA|||The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.||0.35|-0.51|0.708
91703543|NCT01606202|183301693|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.57||||0.852|TWO_SIDED|95.0|-6.62|5.48|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.||5.48|-6.62|0.852
91703544|NCT01606202|183301694|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.05||||0.86|TWO_SIDED|95.0|-0.54|0.65|||ANCOVA|||The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.||0.65|-0.54|0.860
91703545|NCT01606202|183301695|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.873|TWO_SIDED|95.0|-8.56|7.27|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.||7.27|-8.56|0.873
91703546|NCT01606202|183301696|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.07||||0.83|TWO_SIDED|95.0|-0.61|0.75|||ANCOVA|||The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.||0.75|-0.61|0.830
91703547|NCT01606202|183301697|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.4||||0.86|TWO_SIDED|95.0|-4.08|4.88|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.||4.88|-4.08|0.860
91703548|NCT01606202|183301698|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.142|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.||0.05|-0.33|0.142
91703549|NCT01606202|183301699|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.824|TWO_SIDED|95.0|-1.13|0.9|||ANCOVA|||The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.||0.90|-1.13|0.824
91703550|NCT01606202|183301700|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.04||||0.847|TWO_SIDED|95.0|-0.49|0.4|||ANCOVA|||The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.||0.40|-0.49|0.847
91703551|NCT01606202|183301701|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.29||||0.287|TWO_SIDED|95.0|-3.74|1.16|||ANCOVA|||The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.||1.16|-3.74|0.287
91703552|NCT01606202|183301702|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|33.86|||<|0.001|TWO_SIDED|95.0|17.07|50.64|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||50.64|17.07|<0.001
91530824|NCT03844321|182937749|SUPERIORITY|||||||0.319||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.319
91703553|NCT01606202|183301703|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.93||||0.032|TWO_SIDED|95.0|-3.69|-0.16|||ANCOVA|||The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.||-0.16|-3.69|0.032
91703554|NCT03019003|183301708|OTHER||||||<|0.036|||||||t-test, 2 sided|||||||<0.036
91703555|NCT01593254|183301710|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
91703556|NCT00561470|183301750|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.817||||0.0032|TWO_SIDED|95.34|0.713|0.937||Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|||0.937|0.713|0.0032
91703557|NCT00561470|183301751|SUPERIORITY_OR_OTHER||Stratified Hazard ratio|0.758||||7e-05|TWO_SIDED|99.99|0.578|0.995||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.|||0.995|0.578|0.00007
91703558|NCT00561470|183301752|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Stratified Cochran-Mantel-Haenszel|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||||0.0001
91703559|NCT01592292|183301759|SUPERIORITY_OR_OTHER|||||||0.3037||||||Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.|ANCOVA|||||||0.3037
91703560|NCT01592292|183301760|SUPERIORITY_OR_OTHER|||||||0.0951||||||Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.0951
91703561|NCT01592292|183301761|SUPERIORITY_OR_OTHER|||||||0.239||||||Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.2390
91703562|NCT01592292|183301762|SUPERIORITY_OR_OTHER|||||||0.3212||||||Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3212
91703563|NCT01592292|183301762|SUPERIORITY_OR_OTHER|||||||0.7097||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7097
91703564|NCT01592292|183301763|SUPERIORITY_OR_OTHER|||||||0.2444||||||Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2444
91703565|NCT01592292|183301763|SUPERIORITY_OR_OTHER|||||||0.3903||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3903
91703566|NCT01592292|183301764|SUPERIORITY_OR_OTHER|||||||0.5306||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5306
91703567|NCT01592292|183301764|SUPERIORITY_OR_OTHER|||||||0.2542||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2542
91703568|NCT01592292|183301765|SUPERIORITY_OR_OTHER|||||||0.2549||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2549
91703569|NCT01592292|183301765|SUPERIORITY_OR_OTHER|||||||0.7644||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7644
91703570|NCT01592292|183301766|SUPERIORITY_OR_OTHER|||||||0.8987||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.8987
91703571|NCT01592292|183301766|SUPERIORITY_OR_OTHER|||||||0.5808||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.5808
91703572|NCT01592292|183301767|SUPERIORITY_OR_OTHER|||||||0.2282||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2282
91497425|NCT02692716|182865270|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.56|||=|0.3605|TWO_SIDED|95.0|0.6|4.01||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||4.01|0.60|= 0.3605
91703573|NCT01592292|183301767|SUPERIORITY_OR_OTHER|||||||0.5849||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5849
91703574|NCT01592292|183301768|SUPERIORITY_OR_OTHER|||||||0.49||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.4900
91703575|NCT01592292|183301768|SUPERIORITY_OR_OTHER|||||||0.1826||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1826
91703576|NCT01592292|183301769|SUPERIORITY_OR_OTHER|||||||0.1894||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1894
91703577|NCT01592292|183301769|SUPERIORITY_OR_OTHER|||||||0.1805||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1805
91703578|NCT01592292|183301770|SUPERIORITY_OR_OTHER|||||||0.0568||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.0568
91703579|NCT01592292|183301771|SUPERIORITY_OR_OTHER|||||||0.1167||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.1167
91703580|NCT02923245|183301785|OTHER||Mean Difference (Final Values)|49.7|||||TWO_SIDED|95.0|23.4|77.2|||||These confidence intervals correspond to the bootstrap analysis|||77.2|23.4|
91703581|NCT02923245|183301786|OTHER||Difference in percentages|15.3||||0.006|TWO_SIDED|95.0|5.3|25.0|||Test of proportions|||||25.0|5.3|0.006
91703582|NCT00793624|183301813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
91703583|NCT00793624|183301813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
91703584|NCT00793624|183301813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.136|<0.0001
91703585|NCT00793624|183301814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.037|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|0.037|0.0002
91703586|NCT00793624|183301814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.044|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.125|0.044|<0.0001
91703587|NCT00793624|183301814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.021||0.0088||95.0|0.014|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.095|0.014|0.0088
91703588|NCT00793624|183301815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.343||0.5843||95.0|-0.485|0.86|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.860|-0.485|0.5843
91497426|NCT02692716|182865270|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.86|||=|0.6227|TWO_SIDED|95.0|0.48|1.55||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.55|0.48|= 0.6227
91703589|NCT00793624|183301815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.345||0.9494||95.0|-0.656|0.699|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.699|-0.656|0.9494
91703590|NCT00793624|183301815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.288|STANDARD_ERROR_OF_MEAN|0.346||0.5099||95.0|-0.908|0.451|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.451|-0.908|0.5099
91703591|NCT00793624|183301816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.442|STANDARD_ERROR_OF_MEAN|1.401||0.0816||95.0|-5.19|0.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.307|-5.190|0.0816
91703592|NCT00793624|183301816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.394|STANDARD_ERROR_OF_MEAN|1.4||0.0155||95.0|-6.141|-0.648|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.648|-6.141|0.0155
91703593|NCT00793624|183301816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.952|STANDARD_ERROR_OF_MEAN|1.396||0.4954||95.0|-3.691|1.787|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.787|-3.691|0.4954
91703594|NCT00793624|183301817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.785|STANDARD_ERROR_OF_MEAN|1.387||0.045||95.0|-5.507|-0.063|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.063|-5.507|0.0450
91703595|NCT00793624|183301817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.144|STANDARD_ERROR_OF_MEAN|1.386||0.0002||95.0|-7.864|-2.425|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-2.425|-7.864|0.0002
91497427|NCT02692716|182865271|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0952|TWO_SIDED|95.0|0.56|1.05||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.05|0.56|= 0.0952
91703596|NCT00793624|183301817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.754|STANDARD_ERROR_OF_MEAN|1.386||0.2061||95.0|-4.474|0.966|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.966|-4.474|0.2061
91703597|NCT00793624|183301818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.871|STANDARD_ERROR_OF_MEAN|1.419||0.1878||95.0|-4.655|0.914|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.914|-4.655|0.1878
91703598|NCT00793624|183301818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.565|STANDARD_ERROR_OF_MEAN|1.427||0.0126||95.0|-6.364|-0.767|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.767|-6.364|0.0126
91703599|NCT00793624|183301818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|1.426||0.9913||95.0|-2.782|2.814|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.814|-2.782|0.9913
91703600|NCT00793624|183301819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034||95.0|-4.751|-0.94|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||-0.940|-4.751|0.0034
91703601|NCT00793624|183301819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004||95.0|-5.343|-1.525|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||-1.525|-5.343|0.0004
91703602|NCT00793624|183301819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009||95.0|-3.161|0.665|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 10 mcg qd minus Placebo||0.665|-3.161|0.2009
91703603|NCT00793624|183301820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.146|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.226|0.146|<0.0001
91703604|NCT00793624|183301820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.126|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.126|<0.0001
91703605|NCT00793624|183301820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.166|0.246|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.246|0.166|<0.0001
91703606|NCT00793624|183301821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.136|<0.0001
91703607|NCT00793624|183301821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.119|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.119|<0.0001
91703608|NCT00793624|183301821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.152|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.152|<0.0001
91703609|NCT00793624|183301822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.137|0.219|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.219|0.137|<0.0001
91703610|NCT00793624|183301822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.129|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.129|<0.0001
91703611|NCT00793624|183301822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.144|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.144|<0.0001
91703612|NCT00793624|183301823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.103|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.103|<0.0001
91703613|NCT00793624|183301823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.105|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.188|0.105|<0.0001
91703614|NCT00793624|183301823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.13|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.130|<0.0001
91703615|NCT00793624|183301824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.048|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.126|0.048|<0.0001
91703616|NCT00793624|183301824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.118|0.040|<0.0001
91703617|NCT00793624|183301824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
91703618|NCT00793624|183301825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.047|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.125|0.047|<0.0001
91703619|NCT00793624|183301825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02||0.0001||95.0|0.038|0.117|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.117|0.038|0.0001
91703620|NCT00793624|183301825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.039|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.039|<0.0001
91703621|NCT00793624|183301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.043|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.043|<0.0001
91703622|NCT00793624|183301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02||0.0002||95.0|0.035|0.114|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.114|0.035|0.0002
91703623|NCT00793624|183301826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.02||0.0037||95.0|0.019|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.100|0.019|0.0037
91703624|NCT00793624|183301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.02||0.0016||95.0|0.025|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.025|0.0016
91703625|NCT00793624|183301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02||0.0276||95.0|0.005|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.005|0.0276
91497428|NCT02692716|182865272|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.04||||0.8583|TWO_SIDED|95.0|0.66|1.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.||1.66|0.66|0.8583
91703626|NCT00793624|183301827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.021||0.0426||95.0|0.001|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.082|0.001|0.0426
91703627|NCT00793624|183301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0237||95.0|0.006|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.006|0.0237
91703628|NCT00793624|183301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.021||0.0175||95.0|0.009|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.090|0.009|0.0175
91497429|NCT02692716|182865273|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.76||||0.4485|TWO_SIDED|95.0|0.37|1.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.56|0.37|0.4485
91497430|NCT02692716|182865274|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.51||||0.0078|TWO_SIDED|95.0|0.31|0.84||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.84|0.31|0.0078
91497431|NCT02692716|182865275|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.42|2.3||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.||2.30|1.42|<0.0001
91703629|NCT00793624|183301828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.0339||95.0|0.003|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.003|0.0339
91703630|NCT00793624|183301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.021||0.0537||95.0|-0.001|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.081|-0.001|0.0537
91703631|NCT00793624|183301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.021||0.0808||95.0|-0.004|0.078|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.078|-0.004|0.0808
91703632|NCT00793624|183301829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.021||0.2579||95.0|-0.017|0.065|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.065|-0.017|0.2579
91703633|NCT00793624|183301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.021||0.0011||95.0|0.027|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.109|0.027|0.0011
91703634|NCT00793624|183301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.021||0.0069||95.0|0.018|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.018|0.0069
91703635|NCT00793624|183301830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
91703636|NCT00793624|183301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.220|0.135|<0.0001
91703637|NCT00793624|183301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.108|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.108|<0.0001
91703638|NCT00793624|183301831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.148|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.148|<0.0001
91703639|NCT00793624|183301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.124|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.124|<0.0001
91703640|NCT00793624|183301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.109|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.109|<0.0001
91703641|NCT00793624|183301832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.139|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.139|<0.0001
91703642|NCT00793624|183301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.122|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.208|0.122|<0.0001
91703643|NCT00793624|183301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.116|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.203|0.116|<0.0001
91703644|NCT00793624|183301833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.13|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.130|<0.0001
91497432|NCT02564042|182865307|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID has been presented|||76.6|25.9|
91497433|NCT02564042|182865307|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD has been presented|||73.2|22.2|
91497434|NCT02564042|182865307|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID has been presented|||60.5|6.3|
91497435|NCT02564042|182865307|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD has been presented|||55.9|1.6|
91497436|NCT02564042|182865308|OTHER||Proportion difference|2.9|||||TWO_SIDED|95.0|-21.0|26.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented|||26.6|-21.0|
91497437|NCT02564042|182865308|OTHER||Proportion difference|6.3||||||95.0|-20.5|32.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||32.4|-20.5|
91497438|NCT02564042|182865308|OTHER||Proportion difference|15.2|||||TWO_SIDED|95.0|-9.6|39.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented|||39.1|-9.6|
91703645|NCT00793624|183301834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.104|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.191|0.104|<0.0001
91497439|NCT02564042|182865308|OTHER||Proportion difference|3.3|||||TWO_SIDED|95.0|-23.6|29.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented|||29.9|-23.6|
91497440|NCT02564042|182865308|OTHER||Proportion difference|3.1|||||TWO_SIDED|95.0|-22.2|28.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||28.1|-22.2|
91497441|NCT02564042|182865308|OTHER||Proportion difference|27.6|||||TWO_SIDED|95.0|-0.5|52.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||52.4|-0.5|
91703646|NCT00793624|183301834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.112|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.112|<0.0001
91703647|NCT00793624|183301834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.123|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.211|0.123|<0.0001
91703648|NCT00793624|183301835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.183|0.095|<0.0001
91703649|NCT00793624|183301835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.184|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.184|0.095|<0.0001
91703650|NCT00793624|183301835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.117|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.206|0.117|<0.0001
91703651|NCT00793624|183301836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.149|0.297|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.297|0.149|<0.0001
91703652|NCT00793624|183301836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.161|<0.0001
91703653|NCT00793624|183301836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.233|0.381|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.381|0.233|<0.0001
91703654|NCT00793624|183301837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.161|<0.0001
91703655|NCT00793624|183301837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.175|0.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.324|0.175|<0.0001
91703656|NCT00793624|183301837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.235|0.384|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.384|0.235|<0.0001
91703657|NCT00793624|183301838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.135|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.285|0.135|<0.0001
91497442|NCT02564042|182865308|OTHER||Proportion difference|25.8|||||TWO_SIDED|95.0|-0.4|49.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented|||49.3|-0.4|
91497443|NCT02564042|182865308|OTHER||Proportion difference|9.2|||||TWO_SIDED|95.0|-18.4|35.7|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||35.7|-18.4|
91497444|NCT02564042|182865308|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.7|31.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented|||31.7|-19.7|
91497445|NCT02564042|182865308|OTHER||Proportion difference|45.0|||||TWO_SIDED|95.0|16.6|68.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||68.4|16.6|
91497446|NCT02564042|182865308|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
91497447|NCT02564042|182865308|OTHER||Proportion difference|32.0|||||TWO_SIDED|95.0|3.5|57.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented|||57.2|3.5|
91497448|NCT02564042|182865308|OTHER||Proportion difference|34.4|||||TWO_SIDED|95.0|6.3|58.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented|||58.7|6.3|
91497449|NCT02564042|182865308|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented|||72.4|20.1|
91497450|NCT02564042|182865308|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
91703658|NCT00793624|183301838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.179|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.179|<0.0001
91703659|NCT00793624|183301838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.201|0.352|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.352|0.201|<0.0001
91703660|NCT00793624|183301839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.107|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.107|<0.0001
91703661|NCT00793624|183301839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.139|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.139|<0.0001
91703662|NCT00793624|183301839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.318|0.166|<0.0001
91703663|NCT00793624|183301840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.103|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.256|0.103|<0.0001
91703664|NCT00793624|183301840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.126|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.280|0.126|<0.0001
91703665|NCT00793624|183301840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.320|0.166|<0.0001
91703666|NCT00793624|183301841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.039||0.0781||95.0|-0.008|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.143|-0.008|0.0781
91703667|NCT00793624|183301841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.039||0.0455||95.0|0.002|0.153|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.153|0.002|0.0455
91703668|NCT00793624|183301841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.029||95.0|0.009|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.160|0.009|0.0290
91703669|NCT00793624|183301842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.035|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.035|0.0043
91703670|NCT00793624|183301842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.039||0.0007||95.0|0.055|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.055|0.0007
91703671|NCT00793624|183301842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.039||0.0005||95.0|0.06|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.212|0.060|0.0005
91703672|NCT00793624|183301843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.039||0.0136||95.0|0.02|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.020|0.0136
91703673|NCT00793624|183301843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.039||0.0076||95.0|0.028|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.028|0.0076
91497451|NCT02564042|182865308|OTHER||Proportion difference|30.4|||||TWO_SIDED|95.0|1.0|56.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||56.1|1.0|
91497452|NCT02564042|182865308|OTHER||Proportion difference|41.4|||||TWO_SIDED|95.0|12.7|65.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||65.0|12.7|
91497453|NCT02564042|182865308|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||72.4|20.1|
91703674|NCT00793624|183301843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.039||0.0294||95.0|0.009|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.163|0.009|0.0294
91703675|NCT00793624|183301844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.039||0.8674||95.0|-0.071|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|-0.071|0.8674
91703676|NCT00793624|183301844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.04||0.6487||95.0|-0.06|0.096|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.096|-0.060|0.6487
91703677|NCT00793624|183301844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.9267||95.0|-0.074|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.081|-0.074|0.9267
91703678|NCT00793624|183301845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.04||0.1603||95.0|-0.022|0.134|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.134|-0.022|0.1603
91703679|NCT00793624|183301845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.04||0.0399||95.0|0.004|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.160|0.004|0.0399
91703680|NCT00793624|183301845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6328||95.0|-0.059|0.098|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.098|-0.059|0.6328
91703681|NCT00793624|183301846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.04||0.127||95.0|-0.017|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.017|0.1270
91703682|NCT00793624|183301846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.04||0.1076||95.0|-0.014|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.014|0.1076
91703683|NCT00793624|183301846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1492||95.0|-0.021|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.137|-0.021|0.1492
91703684|NCT00793624|183301847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.04||0.0385||95.0|0.004|0.162|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.162|0.004|0.0385
91703685|NCT00793624|183301847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.142||95.0|-0.02|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|-0.020|0.1420
91703686|NCT00793624|183301847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.04||0.0965||95.0|-0.012|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.147|-0.012|0.0965
91703687|NCT00793624|183301848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.1394||95.0|-0.019|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.138|-0.019|0.1394
91703688|NCT00793624|183301848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1532||95.0|-0.022|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.022|0.1532
91497454|NCT02564042|182865308|OTHER||Proportion difference|60.1|||||TWO_SIDED|95.0|33.2|80.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||80.1|33.2|
91703689|NCT00793624|183301848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.041||0.5511||95.0|-0.055|0.104|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.104|-0.055|0.5511
91703690|NCT00793624|183301849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.264|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.264|0.108|<0.0001
91497455|NCT02564042|182865308|OTHER||Proportion difference|30.0|||||TWO_SIDED|95.0|0.2|56.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||56.5|0.2|
91497456|NCT02564042|182865308|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|14.4|66.5|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||66.5|14.4|
91703691|NCT00793624|183301849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.128|0.284|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.284|0.128|<0.0001
91703692|NCT00793624|183301849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.205|0.361|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.361|0.205|<0.0001
91703693|NCT00793624|183301850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.131|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.131|<0.0001
91703694|NCT00793624|183301850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.310|0.153|<0.0001
91703695|NCT00793624|183301850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.187|0.344|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.344|0.187|<0.0001
91703696|NCT00793624|183301851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.267|0.108|<0.0001
91703697|NCT00793624|183301851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.159|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.159|<0.0001
91703698|NCT00793624|183301851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.177|0.336|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.336|0.177|<0.0001
91703699|NCT00793624|183301852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.092|0.253|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.253|0.092|<0.0001
91703700|NCT00793624|183301852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.127|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.127|<0.0001
91703701|NCT00793624|183301852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.137|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.298|0.137|<0.0001
91497457|NCT02564042|182865308|OTHER||Proportion difference|52.0|||||TWO_SIDED|95.0|23.2|74.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||74.4|23.2|
91703702|NCT00793624|183301853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003||95.0|0.07|0.231|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.231|0.070|0.0003
91703703|NCT00793624|183301853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.096|0.259|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.259|0.096|<0.0001
91703704|NCT00793624|183301853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.141|0.304|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.304|0.141|<0.0001
91703705|NCT00793624|183301854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.067|STANDARD_ERROR_OF_MEAN|4.639||0.0012|TWO_SIDED|95.0|5.962|24.173|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.173|5.962|0.0012
91703706|NCT00793624|183301854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.999|STANDARD_ERROR_OF_MEAN|4.611||0.0012||95.0|5.949|24.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.049|5.949|0.0012
91703707|NCT00793624|183301854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.642|STANDARD_ERROR_OF_MEAN|4.601||0.0001|TWO_SIDED|95.0|8.61|26.673|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||26.673|8.610|0.0001
91497458|NCT02564042|182865308|OTHER||Proportion difference|52.4|||||TWO_SIDED|95.0|24.4|74.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||74.0|24.4|
91497459|NCT02564042|182865308|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||60.5|6.3|
91497460|NCT02564042|182865308|OTHER||Proportion difference|48.3|||||TWO_SIDED|95.0|19.7|71.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||71.1|19.7|
91497461|NCT02564042|182865308|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
91497462|NCT02564042|182865308|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
91703708|NCT00793624|183301854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.721|STANDARD_ERROR_OF_MEAN|4.606||0.0001|TWO_SIDED|95.0|8.68|26.762|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.762|8.680|0.0001
91703709|NCT00793624|183301854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.471|STANDARD_ERROR_OF_MEAN|4.579|<|0.0001|TWO_SIDED|95.0|9.484|27.458|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||27.458|9.484|<0.0001
91703710|NCT00793624|183301854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.873|STANDARD_ERROR_OF_MEAN|4.548|<|0.0001|TWO_SIDED|95.0|8.947|26.799|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.799|8.947|<0.0001
91703711|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|STANDARD_ERROR_OF_MEAN|0.133||0.0026|TWO_SIDED|95.0|-0.665|-0.141|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.141|-0.665|0.0026
91703712|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.133||0.0141|TWO_SIDED|95.0|-0.587|-0.066|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.066|-0.587|0.0141
91703713|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.132||0.2677|TWO_SIDED|95.0|-0.406|0.113|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.113|-0.406|0.2677
91703714|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.602|STANDARD_ERROR_OF_MEAN|0.171||0.0005|TWO_SIDED|95.0|-0.939|-0.266|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.266|-0.939|0.0005
91703715|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.914|-0.247|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.247|-0.914|0.0007
91703716|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.0391|TWO_SIDED|95.0|-0.683|-0.018|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.018|-0.683|0.0391
91703717|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.991|STANDARD_ERROR_OF_MEAN|0.269||0.0002|TWO_SIDED|95.0|-1.518|-0.464|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.464|-1.518|0.0002
91703718|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.902|STANDARD_ERROR_OF_MEAN|0.267||0.0008|TWO_SIDED|95.0|-1.426|-0.378|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.378|-1.426|0.0008
91703719|NCT00793624|183301855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.473|STANDARD_ERROR_OF_MEAN|0.266||0.0758|TWO_SIDED|95.0|-0.994|0.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.049|-0.994|0.0758
91703720|NCT00793624|183301856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0003||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.2|-0.6|0.0003
91497463|NCT02564042|182865317|OTHER||Proportion difference|-3.6|||||TWO_SIDED|95.0|-28.8|21.9|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented|||21.9|-28.8|
91703721|NCT00793624|183301856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0073||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0073
91703722|NCT00793624|183301856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0017||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0017
91703723|NCT00793624|183301857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0021||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0021
91497464|NCT02564042|182865317|OTHER||Proportion difference|-0.3|||||TWO_SIDED|95.0|-25.4|25.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented|||25.1|-25.4|
91497465|NCT02564042|182865317|OTHER||Proportion difference|9.4|||||TWO_SIDED|95.0|-17.5|35.3|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||35.3|-17.5|
91497466|NCT02564042|182865317|OTHER||Proportion difference|9.1|||||TWO_SIDED|95.0|-15.4|33.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .|||33.3|-15.4|
91497467|NCT02564042|182865317|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-17.1|36.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .|||36.1|-17.1|
91703724|NCT00793624|183301857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
91703725|NCT00793624|183301857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0121||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0121
91703726|NCT00793624|183301858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.032||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0320
91703727|NCT00793624|183301858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0447||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0447
91703728|NCT00793624|183301858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1332||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1332
91703729|NCT00793624|183301859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4105||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.4105
91703730|NCT00793624|183301859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0584||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0584
91703731|NCT00793624|183301859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1006||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1006
91703732|NCT00793624|183301860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.571|STANDARD_ERROR_OF_MEAN|0.335||0.0882||95.0|-0.085|1.227|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.227|-0.085|0.0882
91703733|NCT00793624|183301860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.664|STANDARD_ERROR_OF_MEAN|0.336||0.0484||95.0|0.005|1.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.324|0.005|0.0484
91703734|NCT00793624|183301860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.758|STANDARD_ERROR_OF_MEAN|0.338||0.0252||95.0|0.094|1.421|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.421|0.094|0.0252
91703735|NCT00793624|183301861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.381|STANDARD_ERROR_OF_MEAN|0.34||0.2625||95.0|-0.285|1.047|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.047|-0.285|0.2625
91703736|NCT00793624|183301861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|STANDARD_ERROR_OF_MEAN|0.341||0.1109||95.0|-0.125|1.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.211|-0.125|0.1109
91703737|NCT00793624|183301861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394|STANDARD_ERROR_OF_MEAN|0.343||0.2507||95.0|-0.278|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.278|0.2507
91497468|NCT02564042|182865317|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.3|31.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||31.0|-19.3|
91703738|NCT00793624|183301862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.342||0.4895||95.0|-0.439|0.902|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.902|-0.439|0.4895
91703739|NCT00793624|183301862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.434|STANDARD_ERROR_OF_MEAN|0.344||0.2073||95.0|-0.24|1.107|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.107|-0.240|0.2073
91703740|NCT00793624|183301862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.345||0.9462||95.0|-0.653|0.7|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.700|-0.653|0.9462
91497469|NCT02564042|182865317|OTHER||Proportion difference|9.7|||||TWO_SIDED|95.0|-18.2|36.7|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||36.7|-18.2|
91497470|NCT02564042|182865317|OTHER||Proportion difference|19.4|||||TWO_SIDED|95.0|-6.9|43.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .|||43.6|-6.9|
91497471|NCT02564042|182865317|OTHER||Proportion difference|12.7|||||TWO_SIDED|95.0|-15.1|38.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||38.9|-15.1|
91497472|NCT02564042|182865317|OTHER||Proportion difference|12.5|||||TWO_SIDED|95.0|-13.6|37.4|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .|||37.4|-13.6|
91497473|NCT02564042|182865317|OTHER||Proportion difference|42.3|||||TWO_SIDED|95.0|13.8|66.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||66.0|13.8|
91497474|NCT02564042|182865317|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
91703741|NCT00793624|183301863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.345||0.6309||95.0|-0.511|0.842|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.842|-0.511|0.6309
91703742|NCT00793624|183301863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.348||0.9227||95.0|-0.717|0.649|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.649|-0.717|0.9227
91703743|NCT00793624|183301863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.349||0.503||95.0|-0.451|0.919|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.919|-0.451|0.5030
91703744|NCT00793624|183301864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112|STANDARD_ERROR_OF_MEAN|0.347||0.7459||95.0|-0.793|0.568|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.568|-0.793|0.7459
91703745|NCT00793624|183301864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.351||0.8534||95.0|-0.753|0.623|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.623|-0.753|0.8534
91703746|NCT00793624|183301864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.377|STANDARD_ERROR_OF_MEAN|0.352||0.5099||95.0|-1.068|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.314|-1.068|0.5099
91703747|NCT00793624|183301865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.348||0.785||95.0|-0.587|0.777|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.777|-0.587|0.7850
91703748|NCT00793624|183301865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.383|STANDARD_ERROR_OF_MEAN|0.352||0.2755||95.0|-0.306|1.073|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.073|-0.306|0.2755
91703749|NCT00793624|183301865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.353||0.7618||95.0|-0.584|0.798|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.798|-0.584|0.7618
91703750|NCT00793624|183301866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.19||0.3424||95.0|0.843|1.603|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.603|0.843|0.3424
91703751|NCT00793624|183301866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|STANDARD_ERROR_OF_MEAN|0.195||0.3023||95.0|0.859|1.636|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.636|0.859|0.3023
91703752|NCT00793624|183301866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854|STANDARD_ERROR_OF_MEAN|0.15||0.3589||95.0|0.605|1.205|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.205|0.605|0.3589
91703753|NCT00793624|183301867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.818|STANDARD_ERROR_OF_MEAN|0.841||0.191||95.0|0.734|4.503|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||4.503|0.734|0.1910
91703754|NCT00793624|183301867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.743|STANDARD_ERROR_OF_MEAN|0.817||0.2274||95.0|0.695|4.369|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||4.369|0.695|0.2274
91703755|NCT00793624|183301867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.346|STANDARD_ERROR_OF_MEAN|0.664||0.5538||95.0|0.512|3.538|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||3.538|0.512|0.5538
91703756|NCT00793624|183301868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101|STANDARD_ERROR_OF_MEAN|0.195||0.5577||95.0|0.778|1.557|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.557|0.778|0.5577
91703757|NCT00793624|183301868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017|STANDARD_ERROR_OF_MEAN|0.184||0.9423||95.0|0.714|1.448|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.448|0.714|0.9423
91703758|NCT00793624|183301868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.735|STANDARD_ERROR_OF_MEAN|0.143||0.1097||95.0|0.502|1.076|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.076|0.502|0.1097
91497475|NCT02564042|182865317|OTHER||Proportion difference|33.3|||||TWO_SIDED|95.0|4.8|58.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .|||58.2|4.8|
91497476|NCT02564042|182865317|OTHER||Proportion difference|40.6|||||TWO_SIDED|95.0|12.8|63.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.|||63.9|12.8|
91497477|NCT02564042|182865317|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.|||76.6|25.9|
91703759|NCT00793624|183301869|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2521|STANDARD_ERROR_OF_MEAN|0.2064||0.1729||95.0|0.906|1.7304|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7304|0.9060|0.1729
91703760|NCT00793624|183301869|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.222|STANDARD_ERROR_OF_MEAN|0.2039||0.2297||95.0|0.8808|1.6954|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.6954|0.8808|0.2297
91703761|NCT00793624|183301869|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8968|STANDARD_ERROR_OF_MEAN|0.1575||0.5354||95.0|0.6353|1.2659|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.2659|0.6353|0.5354
91703762|NCT00793624|183301870|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.8821|STANDARD_ERROR_OF_MEAN|1.0358||0.2508||95.0|0.6391|5.543|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||5.5430|0.6391|0.2508
91703763|NCT00793624|183301870|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.3877|STANDARD_ERROR_OF_MEAN|1.3119||0.1135||95.0|0.8122|7.0194|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||7.0194|0.8122|0.1135
91703764|NCT00793624|183301870|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0289|STANDARD_ERROR_OF_MEAN|0.6013||0.9611||95.0|0.3268|3.2395|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||3.2395|0.3268|0.9611
91703765|NCT00793624|183301871|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1621|STANDARD_ERROR_OF_MEAN|0.2075||0.4002||95.0|0.8187|1.6497|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6497|0.8187|0.4002
91703766|NCT00793624|183301871|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0733|STANDARD_ERROR_OF_MEAN|0.1957||0.6983||95.0|0.7503|1.5352|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.5352|0.7503|0.6983
91703767|NCT00793624|183301871|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.781|STANDARD_ERROR_OF_MEAN|0.1516||0.2033||95.0|0.5336|1.1433|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.1433|0.5336|0.2033
91703768|NCT00793624|183301874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
91703769|NCT00793624|183301874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203||95.0|0.082|0.967||See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|pattern mixture model||"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
91703770|NCT00793624|183301874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166||95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
91703771|NCT01712334|183301891|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%-125%.|Ratio (Fieller's theorem)|100.9|||||TWO_SIDED|90.0|99.5|102.3||||||||102.3|99.5|
91703772|NCT00232596|183301893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
91703773|NCT00232596|183301894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91703774|NCT01650545|183301940|SUPERIORITY|||||||0.03|||||||Log Rank|||||||0.03
91703775|NCT02913105|183301944|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.7489|TWO_SIDED|90.0|0.83|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||||1.13|0.83|0.7489
91703776|NCT02913105|183301944|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.72||||0.0005|TWO_SIDED|90.0|0.62|0.84|||ANCOVA|An unstructured variance-covariance structure was used.||||0.84|0.62|0.0005
91703777|NCT02913105|183301944|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.74||||0.0005|TWO_SIDED|90.0|0.65|0.85|||ANCOVA|An unstructured variance-covariance structure was used.||||0.85|0.65|0.0005
91497478|NCT02564042|182865317|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
91497479|NCT02564042|182865317|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||60.5|6.3|
91497480|NCT02564042|182865317|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||55.9|1.6|
91703778|NCT02913105|183301949|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.95||||0.5354|TWO_SIDED|90.0|0.83|1.09|||ANCOVA|||||1.09|0.83|0.5354
91703779|NCT02913105|183301949|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.68|||<|0.0001|TWO_SIDED|90.0|0.59|0.78|||ANCOVA|||||0.78|0.59|<.0001
91703780|NCT02913105|183301949|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.71|||<|0.0001|TWO_SIDED|90.0|0.63|0.8|||ANCOVA|||||0.80|0.63|<.0001
91703781|NCT02913105|183301950|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.389||0.8402|TWO_SIDED|90.0|-0.724|0.567|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.567|-0.724|0.8402
91703782|NCT02913105|183301950|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.144|STANDARD_ERROR_OF_MEAN|0.472||0.7607|TWO_SIDED|90.0|-0.927|0.639|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.639|-0.927|0.7607
91703783|NCT02913105|183301950|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.228|STANDARD_ERROR_OF_MEAN|0.487||0.6406|TWO_SIDED|90.0|-1.037|0.581|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.581|-1.037|0.6406
91703784|NCT02913105|183301950|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.685||0.8185|TWO_SIDED|90.0|-1.294|0.979|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.979|-1.294|0.8185
91703785|NCT02913105|183301950|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.766||0.7804|TWO_SIDED|90.0|-1.485|1.057|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||1.057|-1.485|0.7804
91703786|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.598|STANDARD_ERROR_OF_MEAN|0.402||0.1403|TWO_SIDED|90.0|-1.265|0.07|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.070|-1.265|0.1403
91703787|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.0603|TWO_SIDED|90.0|-1.743|-0.117|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.117|-1.743|0.0603
91703788|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.344|STANDARD_ERROR_OF_MEAN|0.505||0.009|TWO_SIDED|90.0|-2.182|-0.506|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.506|-2.182|0.0090
91703789|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.787|STANDARD_ERROR_OF_MEAN|0.71||0.0134|TWO_SIDED|90.0|-2.965|-0.609|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.609|-2.965|0.0134
91497481|NCT02564042|182865317|OTHER||Proportion difference|51.3|||||TWO_SIDED|95.0|22.0|74.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||74.0|22.0|
91703790|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-2.123|STANDARD_ERROR_OF_MEAN|0.793||0.0087|TWO_SIDED|90.0|-3.439|-0.807|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.807|-3.439|0.0087
91705637|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.62|TWO_SIDED|95.0|-0.43|0.73||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.73|-0.43|0.620
91497482|NCT02564042|182865317|OTHER||Proportion difference|61.5|||||TWO_SIDED|95.0|34.6|81.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||81.0|34.6|
91497483|NCT02564042|182865317|OTHER||Proportion difference|23.9|||||TWO_SIDED|95.0|-6.1|51.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||51.0|-6.1|
91703791|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.519|STANDARD_ERROR_OF_MEAN|0.368||0.1609|TWO_SIDED|90.0|-1.13|0.091|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.091|-1.130|0.1609
91703792|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.444||0.0797|TWO_SIDED|90.0|-1.524|-0.049|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.049|-1.524|0.0797
91703793|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.116|STANDARD_ERROR_OF_MEAN|0.455||0.0159|TWO_SIDED|90.0|-1.872|-0.36|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.360|-1.872|0.0159
91703794|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|0.635||0.0118|TWO_SIDED|90.0|-2.684|-0.575|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.575|-2.684|0.0118
91703795|NCT02913105|183301950|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.909|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|90.0|-3.072|-0.746|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.746|-3.072|0.0076
91497484|NCT02564042|182865317|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|7.8|61.6|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||61.6|7.8|
91497485|NCT02564042|182865317|OTHER||Proportion difference|53.1|||||TWO_SIDED|95.0|24.7|75.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||75.6|24.7|
91703796|NCT02913105|183301951|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.137||0.8127|TWO_SIDED|90.0|-0.26|0.195|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.195|-0.260|0.8127
91703797|NCT02913105|183301951|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.166||0.8901|TWO_SIDED|90.0|-0.298|0.252|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.252|-0.298|0.8901
91703798|NCT02913105|183301951|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.177||0.6209|TWO_SIDED|90.0|-0.381|0.205|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.205|-0.381|0.6209
91703799|NCT02913105|183301951|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.238||0.8398|TWO_SIDED|90.0|-0.444|0.347|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.347|-0.444|0.8398
91703800|NCT02913105|183301951|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.266||0.7839|TWO_SIDED|90.0|-0.515|0.369|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.369|-0.515|0.7839
91703801|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|0.141||0.0911|TWO_SIDED|90.0|-0.476|-0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||-0.006|-0.476|0.0911
91703802|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.172||0.052|TWO_SIDED|90.0|-0.623|-0.053|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.053|-0.623|0.0520
91703803|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.183||0.0085|TWO_SIDED|90.0|-0.793|-0.187|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.187|-0.793|0.0085
91703804|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.247||0.0091|TWO_SIDED|90.0|-1.067|-0.247|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.247|-1.067|0.0091
91703805|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.759|STANDARD_ERROR_OF_MEAN|0.275||0.007|TWO_SIDED|90.0|-1.216|-0.302|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.302|-1.216|0.0070
91703806|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.208|STANDARD_ERROR_OF_MEAN|0.129||0.1092|TWO_SIDED|90.0|-0.423|0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.006|-0.423|0.1092
91497486|NCT02564042|182865317|OTHER||Proportion difference|53.8|||||TWO_SIDED|95.0|25.8|75.5|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||75.5|25.8|
91497487|NCT02564042|182865317|OTHER||Proportion difference|29.4|||||TWO_SIDED|95.0|-0.3|55.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||55.0|-0.3|
91497488|NCT02564042|182865317|OTHER||Proportion difference|35.7|||||TWO_SIDED|95.0|6.5|60.2|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||60.2|6.5|
91497489|NCT02564042|182865317|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
91497490|NCT02564042|182865317|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
91703807|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.315|STANDARD_ERROR_OF_MEAN|0.156||0.0457|TWO_SIDED|90.0|-0.574|-0.056|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.056|-0.574|0.0457
91703808|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.165||0.0162|TWO_SIDED|90.0|-0.676|-0.129|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.129|-0.676|0.0162
91703809|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.608|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|90.0|-0.975|-0.242|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.242|-0.975|0.0070
91703810|NCT02913105|183301951|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.686|STANDARD_ERROR_OF_MEAN|0.244||0.006|TWO_SIDED|90.0|-1.091|-0.281|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.281|-1.091|0.0060
91497491|NCT02564042|182865317|OTHER||Proportion difference|25.0|||||TWO_SIDED|95.0|-35.7|80.6|||||Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented|||80.6|-35.7|
91703811|NCT02913105|183301952|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.009||0.9927|TWO_SIDED|90.0|-0.015|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.014|-0.015|0.9927
91703812|NCT02913105|183301952|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.2794|TWO_SIDED|90.0|-0.007|0.035|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.035|-0.007|0.2794
91703813|NCT02913105|183301952|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.007||0.9032|TWO_SIDED|90.0|-0.012|0.013|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.013|-0.012|0.9032
91497492|NCT01170754|182865344|NON_INFERIORITY|Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score||||||0.45|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.45
91497493|NCT01170754|182865345|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.13|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.13
91497494|NCT01170754|182865346|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.31|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.31
91497495|NCT01170754|182865347|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.87|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.87
91497496|NCT01170754|182865348|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.25|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.25
91703814|NCT02913105|183301952|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.011||0.4163|TWO_SIDED|90.0|-0.009|0.027|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.027|-0.009|0.4163
91497497|NCT01170754|182865349|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.47|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.47
91497498|NCT01170754|182865350|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.34|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.34
91497499|NCT01170754|182865351|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.18|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.18
91497500|NCT01170754|182865352|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.75|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.75
91497501|NCT01170754|182865353|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.92|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.92
91703815|NCT02913105|183301952|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.011||0.7001|TWO_SIDED|90.0|-0.022|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.014|-0.022|0.7001
91703816|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.009||0.5367|TWO_SIDED|90.0|-0.009|0.021|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.021|-0.009|0.5367
91703817|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5496|TWO_SIDED|90.0|-0.014|0.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.030|-0.014|0.5496
91703818|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.008||0.6844|TWO_SIDED|90.0|-0.01|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.016|-0.010|0.6844
91703819|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.011||0.5695|TWO_SIDED|90.0|-0.025|0.012|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.012|-0.025|0.5695
91497502|NCT01170754|182865354|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.6|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.60
91497503|NCT01170754|182865355|NON_INFERIORITY|Inferiority between groups was defined as a difference of 10% in the overall BBPS score.||||||0.98|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance.|t-test, 2 sided|||||||.98
91497504|NCT02692703|182865356|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.|Percentage of Participants|98.0|||||TWO_SIDED|95.0|95.3|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides \>90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|95.3|
91497505|NCT01077856|182865383|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.34|||||TWO_SIDED|95.0|0.89|2.0|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.00|0.89|
91497506|NCT01077856|182865383|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.59|||||TWO_SIDED|95.0|0.0|4.77|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||4.77|0.00|
91703820|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8015|TWO_SIDED|90.0|-0.021|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.016|-0.021|0.8015
91703821|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.008||0.4923|TWO_SIDED|90.0|-0.008|0.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.020|-0.008|0.4923
91703822|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.012||0.62|TWO_SIDED|90.0|-0.025|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.014|-0.025|0.6200
91703823|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.007||0.7423|TWO_SIDED|90.0|-0.009|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.014|-0.009|0.7423
91703824|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.1272|TWO_SIDED|90.0|-0.032|0.001|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.001|-0.032|0.1272
91703825|NCT02913105|183301952|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.01||0.8883|TWO_SIDED|90.0|-0.015|0.017|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.017|-0.015|0.8883
91703826|NCT02913105|183301953|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|1.01||||0.9514|TWO_SIDED|90.0|0.84|1.21|||ANCOVA|||||1.21|0.84|0.9514
91703827|NCT02913105|183301953|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.5168|TWO_SIDED|90.0|0.78|1.12|||ANCOVA|||||1.12|0.78|0.5168
91703828|NCT02913105|183301953|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.374|TWO_SIDED|90.0|0.8|1.07|||ANCOVA|||||1.07|0.80|0.3740
91703829|NCT02913105|183301954|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9453|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.9453
91703830|NCT02913105|183301954|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.4344|TWO_SIDED|90.0|0.96|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.01|0.96|0.4344
91703831|NCT02913105|183301954|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.639|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6390
91703832|NCT02913105|183301954|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.6329|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.02|0.97|0.6329
91703833|NCT02913105|183301954|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.664|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6640
91703834|NCT02913105|183301954|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.7517|TWO_SIDED|90.0|0.98|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.03|0.98|0.7517
91703835|NCT02913105|183301955|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.739|TWO_SIDED|90.0|0.77|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.19|0.77|0.7390
91703836|NCT02913105|183301955|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.3086|TWO_SIDED|90.0|0.72|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.08|0.72|0.3086
91703837|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.288|TWO_SIDED|90.0|0.69|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.08|0.69|0.2880
91703838|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.4446|TWO_SIDED|90.0|0.73|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.12|0.73|0.4446
91703839|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.4127|TWO_SIDED|90.0|0.73|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.11|0.73|0.4127
91703840|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.8074|TWO_SIDED|90.0|0.85|1.25|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.25|0.85|0.8074
91703841|NCT02913105|183301955|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6935|TWO_SIDED|90.0|0.88|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.08|0.88|0.6935
91703842|NCT02913105|183301955|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.9145|TWO_SIDED|90.0|0.9|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.09|0.90|0.9145
91705638|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.67|0.51||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.67|0.792
91497507|NCT01077856|182865383|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|0.86|||||TWO_SIDED|95.0|0.0|2.02|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.02|0.00|
91703843|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.9131|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.12|0.91|0.9131
91703844|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9988|TWO_SIDED|90.0|0.91|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.91|0.9988
91703845|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.5873|TWO_SIDED|90.0|0.94|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.13|0.94|0.5873
91703846|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.905|TWO_SIDED|90.0|0.92|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.92|0.9050
91703847|NCT02913105|183301955|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.1458|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.11|0.99|0.1458
91703848|NCT02913105|183301955|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.2048|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.12|0.98|0.2048
91703849|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1051|TWO_SIDED|90.0|1.0|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.12|1.00|0.1051
91703850|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.0717|TWO_SIDED|90.0|1.01|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.15|1.01|0.0717
91703851|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8083|TWO_SIDED|90.0|0.96|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.06|0.96|0.8083
91497508|NCT02533427|182865388|OTHER||% Geometric Least Square Mean(GLSM)Ratio|107.36|||||TWO_SIDED|90.0|103.19|111.69|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||111.69|103.19|
91497509|NCT02533427|182865389|OTHER||% GLSM Ratio|115.14|||||TWO_SIDED|90.0|106.49|124.5|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||124.50|106.49|
91703852|NCT02913105|183301955|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.5361|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.09|0.96|0.5361
91703853|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0858|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0858
91497510|NCT02533427|182865390|OTHER||% GLSM Ratio|105.43|||||TWO_SIDED|90.0|96.95|114.66|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||114.66|96.95|
91497511|NCT02533427|182865391|OTHER||% GLSM Ratio|248.89|||||TWO_SIDED|90.0|33.11|1870.81|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||1870.81|33.11|
91497512|NCT02533427|182865392|OTHER||% GLSM Ratio|107.71|||||TWO_SIDED|90.0|97.78|118.65|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||118.65|97.78|
91497513|NCT02533427|182865393|OTHER||% GLSM Ratio|115.02|||||TWO_SIDED|90.0|108.12|122.37|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||122.37|108.12|
91497514|NCT02533427|182865394|OTHER||% GLSM Ratio|121.06|||||TWO_SIDED|90.0|106.1|138.12|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||138.12|106.10|
91497515|NCT02533427|182865395|OTHER||% GLSM Ratio|112.11|||||TWO_SIDED|90.0|87.19|144.14|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||144.14|87.19|
91703854|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0096|TWO_SIDED|90.0|0.88|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||0.97|0.88|0.0096
91703855|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0284|TWO_SIDED|90.0|0.88|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||0.98|0.88|0.0284
91703856|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.133|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.01|0.89|0.1330
91703857|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2032|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.01|0.89|0.2032
91703858|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1141|TWO_SIDED|90.0|0.87|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.00|0.87|0.1141
91703859|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1342|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.01|0.88|0.1342
91703860|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0771|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0771
91705639|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.41|TWO_SIDED|95.0|-0.82|0.34||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.34|-0.82|0.410
91497516|NCT02533427|182865396|OTHER||% GLSM Ratio|114.19|||||TWO_SIDED|90.0|107.4|121.39|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||121.39|107.40|
91497517|NCT02533427|182865397|OTHER||% GLSM Ratio|121.62|||||TWO_SIDED|90.0|110.85|133.44|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||133.44|110.85|
91497518|NCT02533427|182865398|OTHER||% GLSM Ratio|92.86|||||TWO_SIDED|90.0|82.55|104.45|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||104.45|82.55|
91497519|NCT01979016|182865415|SUPERIORITY||Least Squares (LS) Mean Difference|-69.4|||<|0.0001|TWO_SIDED|95.0|-92.5|-46.2|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a mixed model repeated measures (MMRM) model.||-46.2|-92.5|< 0.0001
91497520|NCT01979016|182865416|SUPERIORITY||Percentage difference|37.0|||=|0.0006|TWO_SIDED|95.0|18.82|55.25|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||55.25|18.82|= 0.0006
91497521|NCT01979016|182865417|SUPERIORITY||Percentage difference|48.1|||<|0.0001|TWO_SIDED|95.0|28.0|68.3|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||68.30|28.00|< 0.0001
91497522|NCT01979016|182865418|SUPERIORITY||LS Mean Difference|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.8|-1.52|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-1.52|-3.80|< 0.0001
91497523|NCT01979016|182865419|SUPERIORITY||LS Mean Difference|-48.08|||=|0.0001|TWO_SIDED|95.0|-71.31|-24.85|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-24.85|-71.31|= 0.0001
91497524|NCT01979016|182865420|SUPERIORITY||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-29.0|-14.0|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-14.0|-29.0|<0.0001
91497525|NCT01979016|182865421|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|95.0|-41.5|-21.1|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-21.1|-41.5|< 0.0001
91497526|NCT01979016|182865422|SUPERIORITY||LS Mean Difference|-46.6|||<|0.0001|TWO_SIDED|95.0|-62.0|-31.3|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by MMRM model.||-31.3|-62.0|< 0.0001
91703861|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.151|TWO_SIDED|90.0|0.91|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.01|0.91|0.1510
91703862|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.0744|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.00|0.89|0.0744
91703863|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.8365|TWO_SIDED|90.0|0.93|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.06|0.93|0.8365
91703864|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6091|TWO_SIDED|90.0|0.92|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.05|0.92|0.6091
91703865|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.3621|TWO_SIDED|90.0|0.9|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.03|0.90|0.3621
91703866|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.5031|TWO_SIDED|90.0|0.91|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.04|0.91|0.5031
91703867|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9244|TWO_SIDED|90.0|0.96|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.04|0.96|0.9244
91703868|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.236|TWO_SIDED|90.0|0.99|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.08|0.99|0.2360
91703869|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.699|TWO_SIDED|90.0|0.96|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.07|0.96|0.6990
91530825|NCT03844321|182937750|SUPERIORITY|||||||0.838||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.838
91703870|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.159|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.11|0.99|0.1590
91703871|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4256|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.09|0.97|0.4256
91703872|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4901|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.09|0.96|0.4901
91703873|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.3648|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.09|0.97|0.3648
91703874|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8891|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||1.12|0.91|0.8891
91703875|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.4817|TWO_SIDED|90.0|0.85|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.07|0.85|0.4817
91703876|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.6022|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.6022
91703877|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.447|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.07|0.83|0.4470
91703878|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.4342|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.07|0.83|0.4342
91703879|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0891|TWO_SIDED|90.0|0.73|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||0.99|0.73|0.0891
91703880|NCT02913105|183301956|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.226|TWO_SIDED|90.0|0.77|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.04|0.77|0.2260
91703881|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.87||||0.0324|TWO_SIDED|90.0|0.78|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.97|0.78|0.0324
91703882|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0291|TWO_SIDED|90.0|0.76|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||0.96|0.76|0.0291
91703883|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.5755|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.5755
91703884|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.307|TWO_SIDED|90.0|0.8|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.05|0.80|0.3070
91703885|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7752|TWO_SIDED|90.0|0.86|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.12|0.86|0.7752
91703886|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.1803|TWO_SIDED|90.0|0.75|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.03|0.75|0.1803
91703887|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.2414|TWO_SIDED|90.0|0.76|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.05|0.76|0.2414
91703888|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0179|TWO_SIDED|90.0|0.77|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.95|0.77|0.0179
91703889|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.1125|TWO_SIDED|90.0|0.8|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.00|0.80|0.1125
91703890|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9572|TWO_SIDED|90.0|0.88|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.12|0.88|0.9572
91705640|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.955||95.0|-0.68|0.65||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.65|-0.68|0.955
91497527|NCT01979016|182865423|SUPERIORITY||Percentage difference|55.6|||<|0.0001|TWO_SIDED|95.0|33.38|77.73|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.||77.73|33.38|< 0.0001
91703891|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7372|TWO_SIDED|90.0|0.87|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.10|0.87|0.7372
91703892|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.6015|TWO_SIDED|90.0|0.92|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.17|0.92|0.6015
91703893|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.7261|TWO_SIDED|90.0|0.89|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.19|0.89|0.7261
91703894|NCT02913105|183301956|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9892|TWO_SIDED|90.0|0.87|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.15|0.87|0.9892
91703895|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0005|TWO_SIDED|90.0|0.87|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.95|0.87|0.0005
91703896|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.0005|TWO_SIDED|90.0|0.84|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.94|0.84|0.0005
91703897|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0062|TWO_SIDED|90.0|0.86|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.96|0.86|0.0062
91703898|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1214|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||1.00|0.89|0.1214
91703899|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.0043|TWO_SIDED|90.0|0.84|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.95|0.84|0.0043
91703900|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2615|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||1.02|0.89|0.2615
91703901|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1331|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.01|0.88|0.1331
91705641|NCT01026818|183305792|SUPERIORITY_OR_OTHER||LS Mean Differences|0.05|STANDARD_ERROR_OF_MEAN|0.33||0.868|TWO_SIDED|95.0|-0.59|0.7||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.70|-0.59|0.868
91497528|NCT01979016|182865423|SUPERIORITY||Percentage difference|51.9|||=|0.0001|TWO_SIDED|95.0|29.59|74.12|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.||74.12|29.59|= 0.0001
91497529|NCT01979016|182865423|SUPERIORITY||Percentage difference|33.3|||=|0.0011|TWO_SIDED|95.0|15.55|51.11|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.||51.11|15.55|= 0.0011
91703902|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85|||<|0.0001|TWO_SIDED|90.0|0.81|0.89|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.89|0.81|<.0001
91703903|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0001|TWO_SIDED|90.0|0.83|0.93|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.93|0.83|0.0001
91703904|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.83|||<|0.0001|TWO_SIDED|90.0|0.79|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.88|0.79|<.0001
91703905|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0002|TWO_SIDED|90.0|0.81|0.92|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.92|0.81|0.0002
91703906|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.82|||<|0.0001|TWO_SIDED|90.0|0.77|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.88|0.77|<.0001
91497530|NCT01979016|182865424|SUPERIORITY||Percentage difference|48.1|||=|0.0002|TWO_SIDED|95.0|27.0|69.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.||69.3|27.0|= 0.0002
91703907|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.84||||0.0002|TWO_SIDED|90.0|0.78|0.9|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.90|0.78|0.0002
91703908|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.228|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.02|0.89|0.2280
91703909|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.009|TWO_SIDED|90.0|0.89|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.97|0.89|0.0090
91703910|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6237|TWO_SIDED|90.0|0.93|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||1.04|0.93|0.6237
91703911|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.008|TWO_SIDED|90.0|0.87|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.97|0.87|0.0080
91497531|NCT01979016|182865424|SUPERIORITY||Percentage difference|11.1|||=|0.0792|TWO_SIDED|95.0|-0.7|23.0|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.||23.0|-0.7|= 0.0792
91497532|NCT01979016|182865424|SUPERIORITY||Percentage difference|7.4|||=|0.1573|TWO_SIDED|95.0|-2.5|17.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.||17.3|-2.5|= 0.1573
91497533|NCT01979016|182865425|SUPERIORITY||LS Mean Difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.3|-6.6|||ANCOVA|||Analysis was performed by a MMRM model.||-6.6|-14.3|< 0.0001
91703912|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0105|TWO_SIDED|90.0|0.86|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.97|0.86|0.0105
91703913|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0217|TWO_SIDED|90.0|0.86|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.98|0.86|0.0217
91497534|NCT01979016|182865426|SUPERIORITY||LS Mean Difference|-46.2|||<|0.0001|TWO_SIDED|95.0|-63.9|-28.5|||ANCOVA|||Analysis was performed by a MMRM model.||-28.5|-63.9|< 0.0001
91497535|NCT01979016|182865428|SUPERIORITY||LS Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.02|-2.39|||ANCOVA|||||-2.39|-5.02|< 0.0001
91497536|NCT02602496|182865472|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9942||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9942
91497537|NCT02602496|182865472|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0062|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0062
91703914|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0031|TWO_SIDED|90.0|0.82|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.94|0.82|0.0031
91705642|NCT01026818|183305793|SUPERIORITY_OR_OTHER||LS Mean Differences|0.33|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.1|0.56||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.56|0.10|0.005
91497538|NCT02602496|182865472|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6843|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6843
91497539|NCT02602496|182865473|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.5096||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.5096
91497540|NCT02602496|182865473|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2276|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2276
91497541|NCT02602496|182865473|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0006|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0006
91497542|NCT02602496|182865474|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9708||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9708
91497543|NCT02602496|182865474|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.1642|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.1642
91497544|NCT02602496|182865474|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6043|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6043
91497545|NCT02602496|182865475|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0868||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.0868
91497546|NCT02602496|182865475|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0083|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0083
91497547|NCT02602496|182865475|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0151|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0151
91497548|NCT02602496|182865476|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9255||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9255
91497549|NCT02602496|182865476|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0454|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0454
91497550|NCT02602496|182865476|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.292|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2920
91497551|NCT02602496|182865477|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2252||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.2252
91497552|NCT02602496|182865477|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.4715|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.4715
91497553|NCT02602496|182865477|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.7157|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.7157
91497554|NCT02602496|182865478|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8323||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.8323
91703915|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.774|TWO_SIDED|90.0|0.95|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.07|0.95|0.7740
91703916|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.1783|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.01|0.89|0.1783
91703917|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0219|TWO_SIDED|90.0|0.84|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||0.97|0.84|0.0219
91497555|NCT02602496|182865478|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8927|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.8927
91497556|NCT02602496|182865478|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.3173|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.3173
91703918|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0719|TWO_SIDED|90.0|0.85|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||0.99|0.85|0.0719
91703919|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.2199|TWO_SIDED|90.0|0.85|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.02|0.85|0.2199
91703920|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.4928|TWO_SIDED|90.0|0.87|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.06|0.87|0.4928
91703921|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.3419|TWO_SIDED|90.0|0.85|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.05|0.85|0.3419
91703922|NCT02913105|183301957|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7281|TWO_SIDED|90.0|0.88|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.09|0.88|0.7281
91703923|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.318|TWO_SIDED|90.0|0.97|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.12|0.97|0.3180
91703924|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.6576|TWO_SIDED|90.0|0.95|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.10|0.95|0.6576
91705643|NCT01026818|183305793|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|0.11||0.041|TWO_SIDED|95.0|0.01|0.45||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.45|0.01|0.041
91497557|NCT02602496|182865479|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.27||||||Corrected for baseline concentrations, age and gender|ANOVA|||||||0.27
91497558|NCT01985867|182865486|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.399|TWO_SIDED|95.0|0.24|1.5|||risk analysis (prospective)|||||1.5|0.24|0.399
91497559|NCT01985867|182865487|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||0.589|TWO_SIDED|95.0|-0.6|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.6|0.589
91497560|NCT01985867|182865488|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.0||||0.005|TWO_SIDED|95.0|0.5|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|0.5|0.005
91703925|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.6035|TWO_SIDED|90.0|0.9|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.06|0.90|0.6035
91703926|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.3261|TWO_SIDED|90.0|0.96|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.17|0.96|0.3261
91497561|NCT01985867|182865489|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.659|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.659
91497562|NCT01985867|182865490|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.790
91497563|NCT01985867|182865491|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.698|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.698
91497564|NCT01985867|182865492|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.3||||0.12|TWO_SIDED|95.0|0.9|6.2|||risk analysis (prospective)|||||6.2|0.9|0.120
91497565|NCT01985867|182865493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
91497566|NCT01985867|182865494|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.5||||0.612|TWO_SIDED|95.0|-0.6|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.6|0.612
91497567|NCT01985867|182865495|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.0||||0.004|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|0.0|0.004
91497568|NCT01985867|182865496|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.708|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.708
91497569|NCT01985867|182865497|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.522|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-1.0|0.522
91497570|NCT01985867|182865498|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.185|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|0.0|0.185
91703927|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.5246|TWO_SIDED|90.0|0.94|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.15|0.94|0.5246
91705644|NCT01026818|183305793|SUPERIORITY_OR_OTHER||LS Mean Differences|0.28|STANDARD_ERROR_OF_MEAN|0.13||0.035||95.0|0.02|0.54||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.54|0.02|0.035
91497571|NCT01985867|182865499|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.973
91497572|NCT01985867|182865500|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.642|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.642
91497573|NCT02648178|182865516|OTHER|We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, by week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), Nicotine, Cotinine, Hydro and Creatinine and CO (Carbon Monoxide) level,by week and their interactions.||||||||||||We tested whether there were significant associations between cigarette smoking and e-cigarette smoking, as well as whether there were significant associations between biomarkers mentioned above with CO level.||We provided estimated values of coefficients from model and their 95% confidence intervals.|||We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.|||
91497574|NCT02205814|182865527|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||||||<0.05
91497575|NCT02205814|182865528|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||All secondary efficacy variables were analysed on the ITT population only. Multiplicity was adjusted using the Hochberg procedure. The continuous secondary efficacy variables were analysed over time and were treated in the same way as the primary efficacy variable with respective output.||||<0.05
91497576|NCT02397785|182865543|SUPERIORITY|||||||0.8979|||||||t-test, 2 sided|||It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.||||0.8979
91497577|NCT02397785|182865544|SUPERIORITY|||||||0.9338|||||||Sign test|||||||0.9338
91497578|NCT02397785|182865545|SUPERIORITY|||||||0.1568|||||||Sign test|||||||0.1568
91497579|NCT02397785|182865546|SUPERIORITY|||||||0.3817|||||||Sign test|||||||0.3817
91497580|NCT02397785|182865547|SUPERIORITY|||||||0.286|||||||Sign test|||||||0.2860
91497581|NCT02397785|182865548|SUPERIORITY|||||||0.2884|||||||Sign test|||||||0.2884
91497582|NCT02397785|182865549|SUPERIORITY|||||||0.0855|||||||Sign test|||||||0.0855
91497583|NCT02397785|182865550|SUPERIORITY|||||||0.0287|||||||Sign test|||||||0.0287
91497584|NCT02397785|182865551|SUPERIORITY|||||||0.2887|||||||Sign test|||||||0.2887
91497585|NCT02397785|182865552|SUPERIORITY|||||||0.9954|||||||Sign test|||||||0.9954
91497586|NCT02397785|182865553|SUPERIORITY|||||||0.0574|||||||Sign test|||||||0.0574
91497587|NCT02397785|182865554|SUPERIORITY|||||||0.7827|||||||Sign test|||||||0.7827
91497588|NCT02397785|182865555|SUPERIORITY|||||||0.2114|||||||Sign test|||||||0.2114
91497589|NCT02397785|182865556|SUPERIORITY|||||||0.4986|||||||Sign test|||||||0.4986
91497590|NCT02397785|182865557|SUPERIORITY|||||||0.461|||||||Sign test|||||||0.4610
91497591|NCT02397785|182865558|SUPERIORITY|||||||0.2556|||||||Sign test|||||||0.2556
91705645|NCT01026818|183305793|SUPERIORITY_OR_OTHER||LS Mean Differences|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.316|TWO_SIDED|95.0|-0.12|0.38||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.38|-0.12|0.316
91497592|NCT02397785|182865559|SUPERIORITY|||||||0.0723|||||||t-test, 2 sided|||||||0.0723
91497593|NCT02397785|182865560|SUPERIORITY|||||||0.7456|||||||t-test, 2 sided|||||||0.7456
91497594|NCT02397785|182865561|SUPERIORITY|||||||0.138|||||||t-test, 2 sided|||||||0.1380
91497595|NCT02397785|182865562|SUPERIORITY|||||||0.3155|||||||t-test, 2 sided|||||||0.3155
91497596|NCT02756689|182865569|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91497597|NCT02756689|182865570|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
91497598|NCT02756689|182865571|SUPERIORITY||Risk Ratio (RR)|2.1||||0.09|TWO_SIDED|95.0|0.8|5.3|||Chi-squared|||||5.3|0.8|0.09
91497599|NCT02756689|182865572|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
91497600|NCT02756689|182865573|SUPERIORITY||Risk Ratio (RR)|3.3||||0.06|TWO_SIDED|95.0|0.9|11.4|||Chi-squared|||||11.4|0.9|0.06
91497601|NCT02756689|182865574|SUPERIORITY||Risk Ratio (RR)|0.8||||0.74|TWO_SIDED|95.0|0.2|2.8|||Chi-squared|||||2.8|0.2|0.74
91497602|NCT02756689|182865575|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91497603|NCT02756689|182865576|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
91497604|NCT02756689|182865577|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91497605|NCT02756689|182865578|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
91497606|NCT02756689|182865579|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91497607|NCT02756689|182865580|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.2|4.7|||Chi-squared|||||4.7|0.2|>0.99
91497608|NCT02756689|182865581|SUPERIORITY||Risk Ratio (RR)|0.7||||0.43|TWO_SIDED|95.0|0.3|1.7|||Chi-squared|||||1.7|0.3|0.43
91497609|NCT02756689|182865582|SUPERIORITY||Risk Ratio (RR)|0.3||||0.09|TWO_SIDED|95.0|0.1|1.3|||Chi-squared|||||1.3|0.1|0.09
91497610|NCT02756689|182865583|SUPERIORITY||Risk Ratio (RR)|0.7||||0.68|TWO_SIDED|95.0|0.1|3.8|||Chi-squared|||||3.8|0.1|0.68
91497611|NCT02756689|182865584|SUPERIORITY||Risk Ratio (RR)|0.8||||0.73|TWO_SIDED|95.0|0.3|2.6|||Chi-squared|||||2.6|0.3|0.73
91497612|NCT02756689|182865585|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
91497613|NCT02756689|182865586|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.1|15.4|||Chi-squared|||||15.4|0.1|>0.99
91497614|NCT02756689|182865587|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
91497615|NCT02756689|182865588|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
91497616|NCT02756689|182865589|SUPERIORITY||Risk Ratio (RR)|0.3||||0.37|TWO_SIDED|95.0|0.03|2.3|||Chi-squared|||||2.3|0.03|0.37
91497617|NCT02756689|182865590|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
91497618|NCT02756689|182865591|SUPERIORITY||Risk Ratio (RR)|0.5||||0.62|TWO_SIDED|95.0|0.05|5.3|||Chi-squared|||||5.3|0.05|0.62
91497619|NCT02756689|182865592|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.3|3.2|||Chi-squared|||||3.2|0.3|>0.99
91497620|NCT02756689|182865593|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||||||0.234
91497621|NCT02756689|182865594|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91497622|NCT02756689|182865595|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91497623|NCT02756689|182865596|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91497624|NCT02756689|182865597|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
91497625|NCT02756689|182865598|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
91497626|NCT02756689|182865599|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91497627|NCT02756689|182865600|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91497628|NCT02756689|182865601|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91497629|NCT02756689|182865602|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
91497630|NCT02756689|182865603|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91497631|NCT02756689|182865604|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91497632|NCT02756689|182865605|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91497633|NCT02756689|182865606|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91497634|NCT02756689|182865607|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91497635|NCT02756689|182865608|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
91497636|NCT02756689|182865609|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
91497637|NCT02557646|182865610|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||Chi-squared|||Cumulative dose of ribavirin \>90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.||||0.0437
91497638|NCT02557646|182865612|SUPERIORITY_OR_OTHER|||||||0.6859|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.||||0.6859
91705646|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|1.75|STANDARD_ERROR_OF_MEAN|1.02||0.086|TWO_SIDED|95.0|-0.25|3.76||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.76|-0.25|0.086
91497639|NCT02557646|182865613|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.||||0.3740
91497640|NCT02557646|182865614|SUPERIORITY_OR_OTHER|||||||0.0263|TWO_SIDED||||||Chi-squared, Corrected|||The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.||||0.0263
91703928|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7519|TWO_SIDED|90.0|0.92|1.14|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.14|0.92|0.7519
91703929|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9577|TWO_SIDED|90.0|0.89|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.12|0.89|0.9577
91703930|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.1||||0.016|TWO_SIDED|90.0|1.03|1.18|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.18|1.03|0.0160
91703931|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.13||||0.0052|TWO_SIDED|90.0|1.05|1.21|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.21|1.05|0.0052
91703932|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1822|TWO_SIDED|90.0|0.99|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.15|0.99|0.1822
91703933|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.14||||0.0159|TWO_SIDED|90.0|1.04|1.24|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.24|1.04|0.0159
91703934|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1524|TWO_SIDED|90.0|0.99|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.19|0.99|0.1524
91703935|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1749|TWO_SIDED|90.0|0.98|1.2|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.20|0.98|0.1749
91703936|NCT02913105|183301957|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7503|TWO_SIDED|90.0|0.92|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.13|0.92|0.7503
91703937|NCT02913105|183301958|OTHER|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|5.52||0.2073|TWO_SIDED|90.0|-2.161|16.178|||ANCOVA|||||16.178|-2.161|0.2073
91497641|NCT02557646|182865615|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.||||0.0475
91497642|NCT02557646|182865621|SUPERIORITY_OR_OTHER|||||||0.1499|TWO_SIDED||||||Chi-squared|||The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.1499
91497643|NCT02557646|182865622|SUPERIORITY_OR_OTHER|||||||0.5885|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.5885
91497644|NCT02557646|182865623|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.0062
91497645|NCT01288469|182865640|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.82|||<|0.0001|TWO_SIDED|95.0|-65.62|-46.03||Threshold for significance ≤0.05.|ANCOVA||Alirocumab vs. placebo|Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.||-46.03|-65.62|<0.0001
91497646|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.62|||||TWO_SIDED|90.0|-1.2|2.44||||||Comparison at 0.5 hours postdose.||2.44|-1.20|
91497647|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.89|||||TWO_SIDED|90.0|1.05|4.73||||||Comparison at 2.0 hours postdose.||4.73|1.05|
91497648|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.11|||||TWO_SIDED|90.0|0.28|3.95||||||Comparison at 3.0 hours postdose.||3.95|0.28|
91497649|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 4.0 hours postdose.||3.32|-0.36|
91497650|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 5.0 hours postdose.||3.32|-0.36|
91497651|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.48|||||TWO_SIDED|90.0|1.64|5.32||||||Comparison at 6.0 hours postdose.||5.32|1.64|
91497652|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12|||||TWO_SIDED|90.0|0.27|3.97||||||Comparison at 8.0 hours postdose.||3.97|0.27|
91497653|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.67|||||TWO_SIDED|90.0|-0.17|3.51||||||Comparison at 12.0 hours postdose.||3.51|-0.17|
91497654|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.01|||||TWO_SIDED|90.0|-1.57|3.59||||||Comparison at 0.5 hours postdose.||3.59|-1.57|
91703938|NCT02913105|183301958|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.23|STANDARD_ERROR_OF_MEAN|5.62||0.2014|TWO_SIDED|90.0|-2.106|16.563|||ANCOVA|||||16.563|-2.106|0.2014
91530826|NCT03844321|182937750|SUPERIORITY|||||||0.89||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.890
91530827|NCT03844321|182937751|SUPERIORITY|||||||0.425||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.425
91703939|NCT02913105|183301958|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.93||0.9645|TWO_SIDED|90.0|-7.974|8.414|||ANCOVA|||||8.414|-7.974|0.9645
91497655|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.99|||||TWO_SIDED|90.0|2.4|7.57||||||Comparison at 2.0 hours postdose.||7.57|2.40|
91497656|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.28|||||TWO_SIDED|90.0|3.71|8.86||||||Comparison at 3.0 hours postdose.||8.86|3.71|
91497657|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.35|||||TWO_SIDED|90.0|3.78|8.93||||||Comparison at 4.0 hours postdose.||8.93|3.78|
91497658|NCT01606436|182865653|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.71|||||TWO_SIDED|90.0|2.11|7.31||||||Comparison at 12.0 hours postdose.||7.31|2.11|
91497659|NCT01911689|182865666|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the Control group and AP group.||||<0.01
91497660|NCT01911689|182865667|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the edematous AP and necrotizing AP||||0.05
91497661|NCT01911689|182865668|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Analysis of variance (ANOVA) was used to assess the differences in the T2\* value between the mild, moderate, and severe AP groups according to the MRSI score.||||<0.01
91497662|NCT01911689|182865668|SUPERIORITY_OR_OTHER|||||||0.0111|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value in the mild and moderate AP according to MRSI||||0.0111
91497663|NCT01911689|182865668|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the mild and severe AP||||0.002
91497664|NCT01911689|182865668|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the moderate and severe AP according to MRSI||||0.071
91497665|NCT01911689|182865669|SUPERIORITY_OR_OTHER|||||||0.629|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.629
91497666|NCT00748033|182865673|OTHER|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0650
91497667|NCT00748033|182865674|OTHER|||||||0.2487|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.2487
91497668|NCT00748033|182865675|OTHER|||||||0.7288|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.7288
91497669|NCT00748033|182865676|OTHER|||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0045
91497670|NCT00748033|182865677|OTHER|||||||0.4561|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at insertion.||||0.4561
91497671|NCT00748033|182865678|OTHER|||||||0.1797|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at withdrawal.||||0.1797
91703940|NCT01663857|183301999|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.4
91703941|NCT01663857|183302001|SUPERIORITY|||||||0.4686|||||||Log Rank|||||||0.4686
91703942|NCT01172808|183302014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.291|0.181|<0.0001
91703943|NCT01172808|183302014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.142|0.253|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre , week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.253|0.142|<0.0001
91703944|NCT01172808|183302015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.126|0.244|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.244|0.126|<0.0001
91703945|NCT01172808|183302015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.092|0.211|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction.||0.211|0.092|<0.0001
91703946|NCT01172808|183302016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.114|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.114|<0.0001
91703947|NCT01172808|183302016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.031||0.0008|TWO_SIDED|95.0|0.042|0.162|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model. Spatial power used as covariance structure. The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||0.162|0.042|0.0008
91703948|NCT01172808|183302017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.032||0.0001|TWO_SIDED|95.0|0.062|0.189|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.189|0.062|0.0001
91703949|NCT01172808|183302017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.033||0.02|TWO_SIDED|95.0|0.012|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.012|0.0200
91703950|NCT01172808|183302018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.171|0.278|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.278|0.171|<0.0001
91703951|NCT01172808|183302018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.141|0.249|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.249|0.141|<0.0001
91703952|NCT01172808|183302019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.1|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.100|<0.0001
91703953|NCT01172808|183302019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.029||0.0003|TWO_SIDED|95.0|0.049|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.049|0.0003
91703954|NCT01172808|183302020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.907|STANDARD_ERROR_OF_MEAN|4.994|<|0.0001|TWO_SIDED|95.0|28.113|47.7|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||47.700|28.113|<0.0001
91703955|NCT01172808|183302020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.677|STANDARD_ERROR_OF_MEAN|5.023|<|0.0001|TWO_SIDED|95.0|23.825|43.529|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||43.529|23.825|<0.0001
91703956|NCT01172808|183302021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.066||0.2717|TWO_SIDED|95.0|-0.057|0.203|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.203|-0.057|0.2717
91703957|NCT01172808|183302021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.067||0.2956|TWO_SIDED|95.0|-0.061|0.201|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.201|-0.061|0.2956
91703958|NCT01172808|183302022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|-0.318|-0.085|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.085|-0.318|0.0007
91703959|NCT01172808|183302022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.06||0.0262|TWO_SIDED|95.0|-0.25|-0.016|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.016|-0.250|0.0262
91703960|NCT01172808|183302023|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0377|TWO_SIDED|95.0|1.02|2.11||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||2.11|1.02|0.0377
91703961|NCT01172808|183302023|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.22|2.54||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||2.54|1.22|0.0022
91703962|NCT01172808|183302024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.591|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|21.726|39.455|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||39.455|21.726|<0.0001
91497672|NCT00748033|182865679|OTHER|||||||0.5171|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.5171
91497673|NCT00748033|182865680|OTHER|||||||0.7105|||||||Wilcoxon (Mann-Whitney)|||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.7105
91497674|NCT00748033|182865681|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
91497675|NCT00748033|182865682|OTHER|||||||0.0346|||||||Wilcoxon (Mann-Whitney)|||||||0.0346
91497676|NCT00748033|182865683|OTHER|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||||||0.0016
91497677|NCT03334448|182865686|SUPERIORITY||Ratio of Geometric Least Square Means|0.83|||||TWO_SIDED|90.0|0.818|0.957||||||||0.957|0.818|
91497678|NCT03334448|182865687|SUPERIORITY||Ration of Lease Square Means|0.97|||||TWO_SIDED|90.0|0.83|1.09||||||||1.09|0.83|
91497679|NCT02326025|182865688|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.964|1.13|||||Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.|||1.13|0.964|
91497680|NCT02326025|182865688|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.957|1.11||||||||1.11|0.957|
91497681|NCT02326025|182865689|SUPERIORITY||Ratio of LS Means|0.944|||||TWO_SIDED|90.0|0.77|1.16||||||||1.16|0.770|
91497682|NCT02326025|182865689|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.801|1.33||||||||1.33|0.801|
91497683|NCT02643082|182865720|SUPERIORITY||LS Mean ratio between treatments|1.75|||<|0.0001|TWO_SIDED|95.0|1.65|1.86|||Mixed Models Analysis|||||1.86|1.65|<0.0001
91497684|NCT02643082|182865721|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.26|0.33|||Mixed Models Analysis|||||0.33|0.26|<0.0001
91497685|NCT02643082|182865722|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.25|0.33|||Mixed Models Analysis|||||0.33|0.25|<0.0001
91497686|NCT02643082|182865723|SUPERIORITY||LS Mean ratio between treatments|1.79|||<|0.0001|TWO_SIDED|95.0|1.67|1.92|||Mixed Models Analysis|||||1.92|1.67|<0.0001
91497687|NCT02643082|182865724|SUPERIORITY||LS Mean Difference Between Treatments|0.443|||<|0.0001|TWO_SIDED|95.0|0.318|0.569|||Mixed Models Analysis|||||0.569|0.318|<0.0001
91703963|NCT01172808|183302024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.66|STANDARD_ERROR_OF_MEAN|4.533|<|0.0001|TWO_SIDED|95.0|14.772|32.549|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||32.549|14.772|<0.0001
91703964|NCT01172808|183302025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.16|STANDARD_ERROR_OF_MEAN|4.447|<|0.0001|TWO_SIDED|95.0|19.44|36.88|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||36.880|19.440|<0.0001
91703965|NCT01172808|183302025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|STANDARD_ERROR_OF_MEAN|4.462|<|0.0001|TWO_SIDED|95.0|15.619|33.12|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.120|15.619|<0.0001
91703966|NCT01172808|183302026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.603||0.355|TWO_SIDED|95.0|-1.74|0.624|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.624|-1.740|0.3550
91703967|NCT01172808|183302026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.608||0.0094|TWO_SIDED|95.0|0.388|2.771|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||2.771|0.388|0.0094
91497688|NCT02643082|182865725|SUPERIORITY||LS Mean ratio between treatments|0.87|||<|0.0001|TWO_SIDED|95.0|0.82|0.92|||Mixed Models Analysis|||||0.92|0.82|<0.0001
91497689|NCT02289417|182865726|SUPERIORITY||Stratified Difference|19.2||||0.0142|TWO_SIDED|95.0|3.4|33.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of oral (PO) corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.6|3.4|0.0142
91497690|NCT02289417|182865726|SUPERIORITY||Stratified Difference|7.7||||0.2689|TWO_SIDED|95.0|-6.9|22.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method|||22.0|-6.9|0.2689
91497691|NCT02289417|182865727|SUPERIORITY||Stratified Difference|14.6||||0.1224|TWO_SIDED|95.0|-3.6|31.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.5|-3.6|0.1224
91497692|NCT02289417|182865727|SUPERIORITY||Stratified Difference|19.4||||0.0401|TWO_SIDED|95.0|1.1|36.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.0|1.1|0.0401
91497693|NCT02289417|182865728|SUPERIORITY||Stratified Difference|5.2||||0.2472|TWO_SIDED|95.0|-5.7|16.7|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||16.7|-5.7|0.2472
91497694|NCT02289417|182865728|SUPERIORITY||Stratified Difference|3.1||||0.4628|TWO_SIDED|95.0|-7.5|14.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||14.6|-7.5|0.4628
91497695|NCT02289417|182865729|SUPERIORITY||Stratified Difference|32.0||||0.0005|TWO_SIDED|95.0|13.8|47.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.4|13.8|0.0005
91497696|NCT02289417|182865729|SUPERIORITY||Stratified Difference|3.7||||0.6878|TWO_SIDED|95.0|-14.4|21.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.5|-14.4|0.6878
91497697|NCT02289417|182865730|SUPERIORITY||Stratified Difference|11.5||||0.1388|TWO_SIDED|95.0|-4.1|26.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||26.1|-4.1|0.1388
91703968|NCT01172808|183302027|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.03||0.0069|TWO_SIDED|95.0|0.022|0.139|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.139|0.022|0.0069
91703969|NCT01172808|183302027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.03||0.081|TWO_SIDED|95.0|-0.006|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.006|0.0810
91703970|NCT01172808|183302028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.031||0.0363|TWO_SIDED|95.0|0.004|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.004|0.0363
91703971|NCT01172808|183302028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.031||0.2077|TWO_SIDED|95.0|-0.022|0.1|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.100|-0.022|0.2077
91703972|NCT01172808|183302029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|STANDARD_ERROR_OF_MEAN|0.14||0.2447|TWO_SIDED|95.0|-0.436|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.436|0.2447
91703973|NCT01172808|183302029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.14||0.3046|TWO_SIDED|95.0|-0.131|0.419|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.419|-0.131|0.3046
91703974|NCT01172808|183302030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.029||0.1178|TWO_SIDED|95.0|-0.011|0.102|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.102|-0.011|0.1178
91703975|NCT01172808|183302030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.029||0.888|TWO_SIDED|95.0|-0.061|0.053|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.053|-0.061|0.8880
91703976|NCT01172808|183302031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
91703977|NCT01172808|183302031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
91703978|NCT02542293|183302062|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0808|TWO_SIDED|95.0|0.485|1.045||The 2-sided p-value was calculated using an unstratified log-rank test.|Log Rank||The HR and confidence interval (CI) were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"Global: Durvalumab + Tremelimumab versus (Vs) Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.045|0.485|0.0808
91703979|NCT02542293|183302063|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.322|1.109|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.109|0.322|
91497698|NCT02289417|182865730|SUPERIORITY||Stratified Difference|13.5||||0.0788|TWO_SIDED|95.0|-1.6|27.7||Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Cochran-Mantel-Haenszel||Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||27.7|-1.6|0.0788
91703980|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.629|1.201|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.201|0.629|
91703981|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.726|1.213|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.213|0.726|
91703982|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.786|1.464|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.464|0.786|
91703983|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.835|1.302|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB \<20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.302|0.835|
91703984|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.758|1.353|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB non-evaluable analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.353|0.758|
91703985|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.309|1.008|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.008|0.309|
91703986|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.56|1.35|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.350|0.560|
91703987|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.614|1.251|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.251|0.614|
91703988|NCT02542293|183302064|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.564|1.08|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.080|0.564|
91703989|NCT02542293|183302065|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.871|1.186|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.186|0.871|
91703990|NCT02542293|183302065|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.018|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25 and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.018|0.480|
91497699|NCT02289417|182865731|SUPERIORITY||Stratified Difference|24.8||||0.0046|TWO_SIDED|95.0|7.5|40.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||40.1|7.5|0.0046
91497700|NCT02289417|182865731|SUPERIORITY||Stratified Difference|6.0||||0.4476||95.0|-9.8|21.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.6|-9.8|0.4476
91497701|NCT02289417|182865732|SUPERIORITY||Stratified Difference|16.7||||0.0755|TWO_SIDED|95.0|-1.4|33.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.5|-1.4|0.0755
91497702|NCT02289417|182865732|SUPERIORITY||Stratified Difference|19.8||||0.037|TWO_SIDED|95.0|1.5|36.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.4|1.5|0.0370
91497703|NCT02289417|182865733|SUPERIORITY||Stratified Difference|14.6||||0.1167|TWO_SIDED|95.0|-3.3|31.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.4|-3.3|0.1167
91497704|NCT02289417|182865733|SUPERIORITY||Stratified Difference|18.1||||0.0534|TWO_SIDED|95.0|-0.3|34.9|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||34.9|-0.3|0.0534
91530828|NCT03844321|182937751|SUPERIORITY|||||||0.733||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.733
91530829|NCT03844321|182937752|SUPERIORITY|||||||0.582||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.582
91703991|NCT02542293|183302065|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.654|1.078|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.078|0.654|
91703992|NCT02542293|183302065|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.289|1.065|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.065|0.289|
91703993|NCT02542293|183302065|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.587|1.081|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.081|0.587|
91703994|NCT02542293|183302065|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.222|0.955|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||0.955|0.222|
91497705|NCT02289417|182865734|SUPERIORITY||Stratified Difference|16.6||||0.0758|TWO_SIDED|95.0|-1.5|33.3|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.3|-1.5|0.0758
91497706|NCT02289417|182865734|SUPERIORITY||Stratified Difference|32.5||||0.0004|TWO_SIDED|95.0|14.9|47.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.5|14.9|0.0004
91497707|NCT02725710|182865739|OTHER|||||||0.56|||||||Regression, Linear|||||||0.56
91703995|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.514|1.146|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.146|0.514|
91703996|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.623|1.189|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.189|0.623|
91703997|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.714|1.193|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.193|0.714|
91703998|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.258|0.818|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||0.818|0.258|
91703999|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.524|1.228|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.228|0.524|
91704000|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.585|1.177|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.177|0.585|
91704001|NCT02542293|183302066|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.534|1.017|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.017|0.534|
91497708|NCT01782222|182865752|SUPERIORITY_OR_OTHER||Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|1.24||0.977|TWO_SIDED|95.0|-2.42|2.5|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.50|-2.42|0.977
91704002|NCT02542293|183302067|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.517|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.517|0.810|
91705647|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|0.47|STANDARD_ERROR_OF_MEAN|1.0||0.637|TWO_SIDED|95.0|-1.5|2.45||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.45|-1.50|0.637
91497709|NCT01782222|182865752|SUPERIORITY_OR_OTHER||Least Square Mean|-0.22|STANDARD_ERROR_OF_MEAN|1.21||0.859|TWO_SIDED|95.0|-2.61|2.18|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.18|-2.61|0.859
91497710|NCT01782222|182865753|SUPERIORITY_OR_OTHER||Least Square Mean|-7.29|STANDARD_ERROR_OF_MEAN|2.53||0.005|TWO_SIDED|95.0|-12.3|-2.28|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-2.28|-12.30|0.005
91704003|NCT02542293|183302067|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.592|2.141|||||The HR and CI interval were calculated using an stratified Cox proportional hazards model, adjusting histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||2.141|0.592|
91704004|NCT02542293|183302067|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.924|1.253|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.253|0.924|
91704005|NCT02542293|183302067|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.655|1.362|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥ 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.362|0.655|
91704006|NCT02542293|183302067|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.621|1.024|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.024|0.621|
91704007|NCT02542293|183302067|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.389|1.317|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.317|0.389|
91704008|NCT02542293|183302067|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.542|1.01|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.010|0.542|
91704009|NCT02542293|183302067|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.335|1.251|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.251|0.335|
91704010|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.236|1.03||||||"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.030|0.236|
91704011|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.288|0.968||||||"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.968|0.288|
91704012|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.336|0.908||||||"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.908|0.336|
91704013|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|1.96|||||TWO_SIDED|95.0|0.752|5.234||||||"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.234|0.752|
91704014|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.482|2.214||||||"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||2.214|0.482|
91704015|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.43|1.548||||||"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.548|0.430|
91704016|NCT02542293|183302068|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.456|1.486||||||"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.486|0.456|
91497711|NCT01782222|182865753|SUPERIORITY_OR_OTHER||Least Square Mean|-6.06|STANDARD_ERROR_OF_MEAN|2.45||0.015|TWO_SIDED|95.0|-10.9|-1.21|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.21|-10.90|0.015
91497712|NCT01782222|182865754|SUPERIORITY_OR_OTHER||Least Square Mean|-3.2|STANDARD_ERROR_OF_MEAN|2.46||0.2|TWO_SIDED|95.0|-8.17|1.76|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.76|-8.17|0.200
91497713|NCT01782222|182865754|SUPERIORITY_OR_OTHER||Least Square Mean|-3.04|STANDARD_ERROR_OF_MEAN|2.55||0.239|TWO_SIDED|95.0|-8.19|2.1|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.10|-8.19|0.239
91704017|NCT02542293|183302069|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.245|0.869|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.869|0.245|
91704018|NCT02542293|183302069|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.124|1.337|||Binomial exact test|||"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.337|0.124|
91704019|NCT02542293|183302069|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.356|0.647|||||The analysis was performed using logistic regression adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.647|0.356|
91704020|NCT02542293|183302069|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.45|1.66|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.660|0.450|
91704021|NCT02542293|183302069|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.443|1.079|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.079|0.443|
91704022|NCT02542293|183302069|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.658|4.919|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||4.919|0.658|
91704023|NCT02542293|183302069|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.449|1.291|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.291|0.449|
91704024|NCT02542293|183302069|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.585|5.27|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.270|0.585|
91704025|NCT02542293|183302070|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.113|0.532|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.532|0.113|
91704026|NCT02542293|183302070|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.196|0.639|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.639|0.196|
91497714|NCT01782222|182865755|SUPERIORITY_OR_OTHER||Least Square Mean|-2.09|STANDARD_ERROR_OF_MEAN|3.23||0.519|TWO_SIDED|95.0|-8.48|4.31|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||4.31|-8.48|0.519
91704027|NCT02542293|183302070|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.233|0.611|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.611|0.233|
91704028|NCT02542293|183302071|SUPERIORITY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.199|0.787|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.787|0.199|
91704029|NCT02542293|183302071|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.183|2.86|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||2.860|0.183|
91497715|NCT01782222|182865755|SUPERIORITY_OR_OTHER||Least Square Mean|-5.06|STANDARD_ERROR_OF_MEAN|3.15||0.111|TWO_SIDED|95.0|-11.29|1.17|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.17|-11.29|0.111
91704030|NCT02542293|183302071|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.324|0.588|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.588|0.324|
91704031|NCT02542293|183302071|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.193|0.761|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.761|0.193|
91704032|NCT02542293|183302074|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.494|1.058|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.058|0.494|
91704033|NCT02542293|183302074|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.607|1.151|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.151|0.607|
91704034|NCT02542293|183302074|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.689|1.146|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.146|0.689|
91704035|NCT02542293|183302075|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.748|1.388|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.388|0.748|
91497716|NCT01782222|182865756|SUPERIORITY_OR_OTHER||Least Square Mean|-3.62|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-7.39|0.15|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||0.15|-7.39|0.060
91497717|NCT01782222|182865756|SUPERIORITY_OR_OTHER||Least Square Mean|-3.88|STANDARD_ERROR_OF_MEAN|1.8||0.034|TWO_SIDED|95.0|-7.46|-0.3|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||-0.30|-7.46|0.034
91705648|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|1.2||0.885|TWO_SIDED|95.0|-2.18|2.53||P-value is for sexual relationship - Month 13.5|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.53|-2.18|0.885
91704036|NCT02542293|183302075|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.36|1.219|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.219|0.360|
91704037|NCT02542293|183302075|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.845|1.147|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.147|0.845|
91704038|NCT02542293|183302075|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.492|1.03|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.030|0.492|
91704039|NCT00310466|183302084|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
91704040|NCT00310466|183302085|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
91704041|NCT00310466|183302087|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANOVA|||||||0.55
91704042|NCT00869557|183302185|NON_INFERIORITY_OR_EQUIVALENCE|"A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.~A total of 71 participants were enrolled in the study (4 fewer than planned)."|Difference in the response rates (%)|2.8|||||TWO_SIDED|95.0|-14.5|20.1|||||The 95% confidence interval was computed using normal approximation stratified by baseline HIV-1 RNA stratum (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.||20.1|-14.5|
91704043|NCT01472939|183302191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.06||||0.128|TWO_SIDED|95.0|-1.743|13.862|||Mixed Models Repeated Measures Analysis|||||13.862|-1.743|0.128
91704044|NCT01472939|183302191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.062|TWO_SIDED|95.0|-0.378|15.212|||Mixed Models Repeated Measures Analysis|||||15.212|-0.378|0.062
91704045|NCT01472939|183302191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.65|TWO_SIDED|95.0|-6.1|9.765|||Mixed Models Repeated Measures Analysis|||||9.765|-6.100|0.650
91497718|NCT01782222|182865757|SUPERIORITY_OR_OTHER||Least Square Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.334|TWO_SIDED|95.0|-1.16|0.4|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.40|-1.16|0.334
91497719|NCT01782222|182865757|SUPERIORITY_OR_OTHER||Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.38||0.968|TWO_SIDED|95.0|-0.74|0.77|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.77|-0.74|0.968
91704046|NCT01472939|183302192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.75||||0.102|TWO_SIDED|95.0|-1.344|14.85|||Mixed Models Repeated Measures Analysis|||||14.850|-1.344|0.102
91497720|NCT01782222|182865758|SUPERIORITY_OR_OTHER||Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|1.26||0.899|TWO_SIDED|95.0|-2.34|2.66|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.66|-2.34|0.899
91497721|NCT01782222|182865758|SUPERIORITY_OR_OTHER||Least Square Mean|-0.33|STANDARD_ERROR_OF_MEAN|1.19||0.785|TWO_SIDED|95.0|-2.68|2.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||2.03|-2.68|0.785
91704047|NCT01472939|183302192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.92||||0.031|TWO_SIDED|95.0|0.814|17.021|||Mixed Models Repeated Measures Analysis|||||17.021|0.814|0.031
91704048|NCT01472939|183302192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.71||||0.175|TWO_SIDED|95.0|-2.54|13.957|||Mixed Models Repeated Measures Analysis|||||13.957|-2.540|0.175
91704049|NCT01472939|183302193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47||||0.064|TWO_SIDED|95.0|-5.087|0.141|||Mixed Models Repeated Measures Analysis|||||0.141|-5.087|0.064
91704050|NCT01472939|183302193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.017|TWO_SIDED|95.0|-5.818|-0.573|||Mixed Models Repeated Measures Analysis|||||-0.573|-5.818|0.017
91704051|NCT01472939|183302193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.114|TWO_SIDED|95.0|-4.813|0.519|||Mixed Models Repeated Measures Analysis|||||0.519|-4.813|0.114
91704052|NCT01492101|183302208|OTHER|Two-sided log-rank test, stratified by geographic region, prior use of eribulin, and receptor status.|Hazard Ratio, log|0.872|||=|0.0835|TWO_SIDED|95.0|0.747|1.019|||Log Rank|||||1.019|0.747|= 0.0835
91704053|NCT01492101|183302209|SUPERIORITY||Hazard Ratio (HR)|0.926|||=|0.3017|TWO_SIDED|95.0|0.798|1.075|||Log Rank|||||1.075|0.798|= 0.3017
91704054|NCT01492101|183302214|EQUIVALENCE|\[2\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.8||||0.635|TWO_SIDED|95.0|-2.65|4.33|||F-test|||Global health status/QoL: change from baseline to last assessment (Week 56)||4.33|-2.65|0.635
91704055|NCT01492101|183302214|EQUIVALENCE|\[3\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|2.1||||0.1656|TWO_SIDED|95.0|-0.88|5.14|||F-test|||||5.14|-0.88|0.1656
91497722|NCT01782222|182865759|SUPERIORITY_OR_OTHER||Least Square Mean|-4.96|STANDARD_ERROR_OF_MEAN|1.99||0.014|TWO_SIDED|95.0|-8.91|-1.01|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.01|-8.91|0.014
91497723|NCT01782222|182865759|SUPERIORITY_OR_OTHER||Least Square Mean|-4.83|STANDARD_ERROR_OF_MEAN|1.92||0.013|TWO_SIDED|95.0|-8.63|-1.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.03|-8.63|0.013
91497724|NCT03200860|182865761|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
91530830|NCT03844321|182937752|SUPERIORITY|||||||0.666||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.666
91530831|NCT03844321|182937753|SUPERIORITY|||||||0.355||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.355
91530832|NCT03844321|182937753|SUPERIORITY|||||||0.361||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.361
91530833|NCT03844321|182937754|SUPERIORITY|||||||0.64||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.640
91530834|NCT03844321|182937754|SUPERIORITY|||||||0.396||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.396
91530835|NCT03844321|182937755|SUPERIORITY|||||||0.004||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.004
91704056|NCT01492101|183302214|EQUIVALENCE|\[4\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Median Difference (Final Values)|0.5||||0.8356|TWO_SIDED|95.0|-3.9|4.82|||F-test|||||4.82|-3.9|0.8356
91530836|NCT03844321|182937755|SUPERIORITY|||||||0.291||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.291
91704057|NCT01492101|183302214|EQUIVALENCE|\[5\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7727|TWO_SIDED|95.0|-2.88|3.88|||F-test|||||3.88|-2.88|0.7727
91497725|NCT03200860|182865762|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
91497726|NCT03200860|182865763|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
91497727|NCT03200860|182865764|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
91497728|NCT03200860|182865765|SUPERIORITY|||||||0.31|||||||Regression, Logistic|||||||0.31
91497729|NCT03200860|182865766|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
91497730|NCT02634320|182865802|OTHER|Statistical test is to confirm the change from baseline is statistically different from 0.||||||0.078||||||Change from baseline at last on-treatment visit|t-test, 2 sided|||||||0.078
91497731|NCT00064844|182865839|SUPERIORITY_OR_OTHER_LEGACY||chi square|7.25|||<|0.01||95.0|||||Chi-squared|df = 1, N = 96||||||<0.01
91497732|NCT01428453|182865840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.8||||0.133|TWO_SIDED|95.0|-12.4|92.0|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-42 and Age.|Comparison of CSF Abeta42 between placebo and rilapladib 250 mg.|||92.0|-12.4|0.133
91704058|NCT01492101|183302214|EQUIVALENCE|\[6\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7446|TWO_SIDED|95.0|-2.56|3.59|||F-test|||||3.59|-2.56|0.7446
91704059|NCT01492101|183302214|EQUIVALENCE|\[7\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.2||||0.9169|TWO_SIDED|95.0|-4.0|4.45|||F-test|||||4.45|-4.0|0.9169
91704060|NCT01492101|183302214|EQUIVALENCE|\[8\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.1||||0.9731|TWO_SIDED|95.0|-3.66|3.79|||F-test|||||3.79|-3.66|0.9731
91704061|NCT01492101|183302214|EQUIVALENCE|\[9\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|7.3|||<|0.0001|TWO_SIDED|95.0|3.88|10.67|||F-test|||||10.67|3.88|<0.0001
91704062|NCT01492101|183302214|EQUIVALENCE|\[10\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1252|TWO_SIDED|95.0|-7.59|0.93|||F-test|||||0.93|-7.59|0.1252
91497733|NCT01428453|182865840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-250.3|STANDARD_ERROR_OF_MEAN|265.66||0.829|TWO_SIDED|95.0|-771.9|271.2|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-40 and Age.|Comparison of CSF Abeta40 between placebo and rilapladib 250 mg.|||271.2|-771.9|0.829
91497734|NCT01428453|182865841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|||||TWO_SIDED|95.0|-0.003|0.036|||||The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Ratio Abeta1-42/Abeta1-40 and Age.|||0.036|-0.003|
91497735|NCT01428453|182865842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.1|STANDARD_ERROR_OF_MEAN|44.4||0.902|TWO_SIDED|95.0|-144.5|30.3|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF tau and Age.|Comparison of CSF tau between placebo and rilapladib 250 mg.|||30.3|-144.5|0.902
91497736|NCT01428453|182865842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.46||0.892|TWO_SIDED|95.0|-7.9|1.8|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF P-tau and Age.|Comparison of P-tau between placebo and rilapladib 250 mg.|||1.8|-7.9|0.892
91497737|NCT01428453|182865843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.167||||0.026|TWO_SIDED|95.0|0.021|0.313||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Working Memory/Executive Function Composite Score, Treatment by Visit and Baseline Working Memory/Executive Function Composite Score by Visit.|Mixed-Model Repeated Measures analysis||A positive treatment difference indicates benefit, relative to placebo.|||0.313|0.021|0.026
91497738|NCT01428453|182865844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.256||0.828|TWO_SIDED|95.0|-0.74|0.26|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Albumin Quotient and Age.||||0.26|-0.74|0.828
91497739|NCT01428453|182865845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.9|1.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta42 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||1.2|-3.9|
91530837|NCT03844321|182937756|SUPERIORITY|||||||0.603||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.603
91704063|NCT01492101|183302214|EQUIVALENCE|\[11\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1717|TWO_SIDED|95.0|-6.83|1.22|||F-test|||||1.22|-6.83|0.1717
91704064|NCT01492101|183302214|EQUIVALENCE|\[12\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.5513|TWO_SIDED|95.0|-5.95|3.18|||F-test|||||3.18|-5.95|0.5513
91704065|NCT01492101|183302214|EQUIVALENCE|\[13\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|8.6||||0.0009|TWO_SIDED|95.0|3.57|13.72|||F-test|||||13.72|3.57|0.0009
91704066|NCT01492101|183302214|EQUIVALENCE|\[14\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.2337|TWO_SIDED|95.0|-7.35|1.8|||F-test|||||1.8|-7.35|0.2337
91736324|NCT03189719|183365729|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.76|||Stratified Log-Rank|||PFS in all participants of the pembrolizumab + SOC arm was compared to PFS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.76|0.55|<0.0001
91704067|NCT01492101|183302214|EQUIVALENCE|\[15\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|10.3|||<|0.0001|TWO_SIDED|95.0|6.6|13.98|||F-test|||||13.98|6.6|<0.0001
91497740|NCT01428453|182865845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||||95.0|-10.2|12.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta40 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||12.2|-10.2|
91497741|NCT01428453|182865846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.016|0.01|||Mixed-Model Repeated Measures analysis||The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||0.010|-0.016|
91497742|NCT01428453|182865848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.067|||||TWO_SIDED|95.0|-0.191|0.057|||Mixed-Model Repeated Measures analysis||"The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit. A positive treatment difference indicates benefit, relative to placebo.~placebo."|||0.057|-0.191|
91704068|NCT01492101|183302214|EQUIVALENCE|\[16\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-3.74|3.69|||F-test|||||3.69|-3.74|0.99
91704069|NCT01492101|183302216|EQUIVALENCE|\[17\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.9||||0.5833|TWO_SIDED|95.0|-2.42|4.29|||F-test|||||4.29|-2.42|0.5833
91704070|NCT01492101|183302216|EQUIVALENCE|\[18\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.3||||0.3098|TWO_SIDED|95.0|-1.24|3.9|||F-test|||||3.9|-1.24|0.3098
91704071|NCT01492101|183302216|EQUIVALENCE|\[19\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.1||||0.6264|TWO_SIDED|95.0|-3.39|5.63|||F-test|||||5.63|-3.39|0.6264
91704072|NCT01492101|183302216|EQUIVALENCE|\[20\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.6||||0.0003|TWO_SIDED|95.0|-7.11|-2.1|||F-test|||||-2.1|-7.11|0.0003
91704073|NCT01492101|183302216|EQUIVALENCE|\[21\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.2473|TWO_SIDED|95.0|-3.84|0.99|||F-test|||||0.99|-3.84|0.2473
91704074|NCT01492101|183302216|EQUIVALENCE|\[22\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.9||||0.0333|TWO_SIDED|95.0|-5.54|-0.23|||F-test|||||-0.23|-5.54|0.0333
91704075|NCT01492101|183302216|EQUIVALENCE|\[23\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.5||||0.2575|TWO_SIDED|95.0|-12.2|3.28|||F-test|||||3.28|-12.2|0.2575
91704076|NCT01492101|183302216|EQUIVALENCE|\[24\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|5.6||||0.1072|TWO_SIDED|95.0|-1.22|12.34|||F-test|||||12.34|-1.22|0.1072
91704077|NCT01004432|183302221|SUPERIORITY_OR_OTHER||Percentage achive ACR 20 response|34.9|||<|0.0001|TWO_SIDED|95.0|30.4|39.4||One sided test adjusting for conducting one interim analysis|Chi-squared|||null hypothesis: proportion \<=0.2||39.4|30.4|<0.0001
91704078|NCT01149421|183302237|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.79|||<|0.001|TWO_SIDED|97.3|-4.58|-1.0||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-1.00|-4.58|<0.001
91704079|NCT01149421|183302237|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.07|||<|0.001|TWO_SIDED|97.3|-2.83|0.68||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.68|-2.83|<0.001
91704080|NCT01149421|183302237|SUPERIORITY_OR_OTHER||||||<|0.001||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||<0.001
91704081|NCT01149421|183302237|SUPERIORITY_OR_OTHER|||||||0.149||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.149
91704082|NCT01149421|183302238|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.66|||<|0.001|TWO_SIDED|97.3|-4.53|-0.79||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-0.79|-4.53|<0.001
91704083|NCT01149421|183302238|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.71|||<|0.001|TWO_SIDED|97.3|-3.54|0.12||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.12|-3.54|<0.001
91497743|NCT01428453|182865848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.982|TWO_SIDED|95.0|0.01|0.267||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Overall Composite Score, Treatment by Visit and Baseline Overall Composite Score by Visit.|Mixed-Model Repeated Measures analysis|The probability (effect size) for change from Baseline in CogState battery overall composite score \>0 is presented.|A positive treatment difference indicates benefit, relative to placebo. Comparison of overall composite score between placebo and rilapladib 250 mg at Week 24.|||0.267|0.010|0.982
91497744|NCT01428453|182865849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.063|||||TWO_SIDED|95.0|-0.257|0.13|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 12. A positive treatment difference indicates benefit, relative to placebo.|||0.130|-0.257|
91497745|NCT01428453|182865849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.13|0.269|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 24. A positive treatment difference indicates benefit, relative to placebo.|||0.269|-0.130|
91497746|NCT04216329|182865858|OTHER|||||||0.02|||||||Students t-test|||||||0.02
91704084|NCT01149421|183302238|SUPERIORITY_OR_OTHER|||||||0.002||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.002
91704085|NCT01149421|183302238|SUPERIORITY_OR_OTHER|||||||0.36||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.36
91704086|NCT01149421|183302239|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.32|||<|0.001|TWO_SIDED|97.3|-0.8|1.43||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.43|-0.80|<0.001
91704087|NCT01149421|183302239|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.42|||<|0.001|TWO_SIDED|97.3|-0.67|1.52||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.52|-0.67|<0.001
91704088|NCT01149421|183302239|SUPERIORITY_OR_OTHER|||||||0.87||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.870
91704089|NCT01149421|183302239|SUPERIORITY_OR_OTHER|||||||0.915||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.915
91704090|NCT01149421|183302239|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.5|||<|0.001|TWO_SIDED|97.3|-0.68|1.68||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.68|-0.68|<0.001
91704091|NCT01149421|183302239|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.16|||<|0.001|TWO_SIDED|97.3|-1.0|1.31||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.31|-1.00|<0.001
91704092|NCT01149421|183302239|SUPERIORITY_OR_OTHER|||||||0.929||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.929
91704093|NCT01149421|183302239|SUPERIORITY_OR_OTHER|||||||0.776||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.776
91704094|NCT01149421|183302240|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|2.84||||0.556|TWO_SIDED|97.3|1.52|4.16||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.16|1.52|0.556
91704095|NCT01149421|183302240|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.62||||0.018|TWO_SIDED|97.3|0.32|2.92||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.92|0.32|0.018
91704096|NCT01149421|183302240|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||1.00
91704097|NCT01149421|183302240|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|3.5||||0.904|TWO_SIDED|97.3|2.1|4.91||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.91|2.10|0.904
91704098|NCT01149421|183302240|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.26||||0.005|TWO_SIDED|97.3|-0.13|2.64||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.64|-0.13|0.005
91736325|NCT03189719|183365730|SUPERIORITY||Difference in Percentage|15.8|||<|0.0001|TWO_SIDED|95.0|9.0|22.5|||One-sided p-value|||ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||22.5|9.0|<0.0001
91736326|NCT03189719|183365731|OTHER||Difference in Percentage|22.8|||<|0.0001|TWO_SIDED|95.0|11.6|33.4|||One-sided p-value|||ORR in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||33.4|11.6|<0.0001
91736327|NCT03189719|183365732|OTHER||Difference in Percentage|12.8||||0.0009|TWO_SIDED|95.0|4.7|20.7|||One-sided p-value|||ORR in ESCC participants of the pembrolizumab + SOC arm was compared to ORR in ESCC participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||20.7|4.7|0.0009
91736328|NCT03189719|183365733|OTHER||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|14.3|33.2|||One-sided p-value|||ORR in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||33.2|14.3|<0.0001
91736329|NCT03189719|183365740|OTHER||Difference in LS Means|-0.1||||0.953|TWO_SIDED|95.0|-3.4|3.2|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a constrained longitudinal data analysis (cLDA) model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||3.20|-3.40|0.9530
91736330|NCT03189719|183365741|OTHER||Difference in LS Means|-1.95||||0.5053|TWO_SIDED|95.0|-7.72|3.82|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.82|-7.72|0.5053
91736331|NCT03189719|183365742|OTHER||Difference in LS Means|-0.06||||0.9742|TWO_SIDED|95.0|-3.93|3.81|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.81|-3.93|0.9742
91736332|NCT03189719|183365743|OTHER||Difference in LS Means|-1.77||||0.481|TWO_SIDED|95.0|-6.71|3.17|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||3.17|-6.71|0.4810
91736333|NCT03189719|183365744|OTHER||Difference in LS Means|-5.54||||0.0436|TWO_SIDED|95.0|-10.93|-0.16|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.16|-10.93|0.0436
91736334|NCT03189719|183365744|OTHER||Difference in LS Means|-2.94||||0.0487|TWO_SIDED|95.0|-5.86|-0.02|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.02|-5.86|0.0487
91736335|NCT03189719|183365744|OTHER||Difference in LS Means|-0.93||||0.5932|TWO_SIDED|95.0|-4.36|2.49|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||2.49|-4.36|0.5932
91497747|NCT04216329|182865858|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
91497748|NCT04216329|182865858|OTHER|||||||0.02|||||||Students t-test|||||||0.02
91497749|NCT04216329|182865858|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
91497750|NCT04216329|182865858|OTHER|||||||0.02|||||||Students t-test|||||||0.02
91497751|NCT04216329|182865858|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
91497752|NCT04216329|182865860|OTHER|||||||0.09|||||||Students t-test|||||||0.09
91497753|NCT04216329|182865860|OTHER|||||||0.09|||||||Students t-test|||||||0.09
91497754|NCT04216329|182865860|OTHER|||||||0.09|||||||Students t-test|||||||0.09
91736336|NCT03189719|183365745|OTHER||Difference in LS Means|-8.68||||0.0564|TWO_SIDED|95.0|-17.59|0.24|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.24|-17.59|0.0564
91736337|NCT03189719|183365745|OTHER||Difference in LS Means|-2.13||||0.3813|TWO_SIDED|95.0|-6.93|2.66|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.66|-6.93|0.3813
91736338|NCT03189719|183365745|OTHER||Difference in LS Means|-5.11||||0.0816|TWO_SIDED|95.0|-10.86|0.65|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.65|-10.86|0.0816
91497755|NCT03918447|182865866|SUPERIORITY||Least Square Means Difference|0.97|STANDARD_ERROR_OF_MEAN|1.122|=|0.3886|TWO_SIDED|95.0|-1.25|3.19|||ANCOVA|||ANCOVA model with baseline eGFR as a covariate, and treatment group as fixed effects.||3.19|-1.25|=0.3886
91497756|NCT03918447|182865868|SUPERIORITY||Least Square Means Difference|7.94|STANDARD_ERROR_OF_MEAN|0.777|<|0.0001|TWO_SIDED|95.0|6.41|9.47|||MMRM|||Mixed model repeated measure (MMRM) model used baseline eGFR as a covariate, and the following fixed factors: treatment group, time (Week 1 to 100, excluding Week 52), and the interaction between treatment and time. Within-participant errors are modeled using an unstructured covariance matrix.||9.47|6.41|<0.0001
91497757|NCT01774968|182865873|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.1||||0.3709|TWO_SIDED|95.0|-0.33|0.12|||Mixed Models Analysis|||Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.||0.12|-0.33|0.3709
91497758|NCT05355805|182865889|SUPERIORITY||Risk Difference (RD)|8.27|STANDARD_ERROR_OF_MEAN|8.075||0.3055|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.3055
91497759|NCT05355805|182865889|SUPERIORITY||Risk Difference (RD)|4.19|STANDARD_ERROR_OF_MEAN|8.427||0.6192|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.6192
91497760|NCT05355805|182865892|SUPERIORITY||Risk Difference (RD)|10.14|STANDARD_ERROR_OF_MEAN|7.229||0.1606|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.1606
91497761|NCT05355805|182865892|SUPERIORITY||Risk Difference (RD)|4.79|STANDARD_ERROR_OF_MEAN|7.294||0.5116|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.5116
91497762|NCT05355805|182865893|SUPERIORITY||Risk Difference (RD)|13.67|STANDARD_ERROR_OF_MEAN|7.019||0.0514|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.0514
91497763|NCT05355805|182865893|SUPERIORITY||Risk Difference (RD)|6.56|STANDARD_ERROR_OF_MEAN|6.764||0.3322|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.3322
91704099|NCT01149421|183302240|SUPERIORITY_OR_OTHER|||||||0.996||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.996
91704100|NCT01149421|183302241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|||<|0.001|TWO_SIDED|95.0|-4.0|-2.09||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-2.09|-4.00|<0.001
91704101|NCT01149421|183302241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.001|TWO_SIDED|95.0|-2.51|-0.64||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-0.64|-2.51|0.001
91704102|NCT01149421|183302241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.1|-2.09||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-2.09|-4.10|<0.001
91704103|NCT01149421|183302241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|||<|0.001|TWO_SIDED|95.0|-2.98|-1.0||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-1.00|-2.98|<0.001
91704104|NCT01149421|183302242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.218|TWO_SIDED|95.0|-1.84|0.42||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||0.42|-1.84|0.218
91704105|NCT01149421|183302242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.931|TWO_SIDED|95.0|-1.16|1.06||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||1.06|-1.16|0.931
91704106|NCT01149421|183302242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.315|TWO_SIDED|95.0|-1.72|0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.55|-1.72|0.315
91704107|NCT01149421|183302242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.465|TWO_SIDED|95.0|-1.54|0.7||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.70|-1.54|0.465
91704108|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||<|0.001|TWO_SIDED|95.0|-5.04|-1.61||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||-1.61|-5.04|<0.001
91704109|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.153|TWO_SIDED|95.0|-2.91|0.46||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.46|-2.91|0.153
91704110|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.002|TWO_SIDED|95.0|-4.66|-1.09||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-1.09|-4.66|0.002
91704111|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.042|TWO_SIDED|95.0|-3.57|-0.07||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.07|-3.57|0.042
91704112|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.221|TWO_SIDED|95.0|-3.23|0.75||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.75|-3.23|0.221
91704113|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.884|TWO_SIDED|95.0|-2.1|1.81||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||1.81|-2.10|0.884
91704114|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.19|TWO_SIDED|95.0|-4.31|-0.39||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.39|-4.31|0.19
91704115|NCT01149421|183302243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.159|TWO_SIDED|95.0|-3.31|0.54||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||0.54|-3.31|0.159
91704116|NCT01149421|183302243|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.122
91704117|NCT01149421|183302243|SUPERIORITY_OR_OTHER|||||||0.601||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.601
91704118|NCT01149421|183302243|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.012
91704119|NCT01149421|183302243|SUPERIORITY_OR_OTHER|||||||0.274||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.274
91704120|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.717|TWO_SIDED|95.0|-0.91|1.32||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.32|-0.91|0.717
91704121|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.427|TWO_SIDED|95.0|-0.65|1.54||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.54|-0.65|0.427
91704122|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.3|TWO_SIDED|95.0|-0.53|1.73||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.73|-0.53|0.300
91704123|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.788|TWO_SIDED|95.0|-0.96|1.26||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.26|-0.96|0.788
91704124|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.098|TWO_SIDED|95.0|-0.2|2.37||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.37|-0.20|0.098
91704125|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.203|TWO_SIDED|95.0|-0.44|2.08||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.08|-0.44|0.203
91704126|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.493|TWO_SIDED|95.0|-0.88|1.82||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.82|-0.88|0.493
91704127|NCT01149421|183302244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.692|TWO_SIDED|95.0|-1.06|1.6||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.60|-1.06|0.692
91704128|NCT01149421|183302244|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.990
91704129|NCT01149421|183302244|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.173
91497764|NCT05355805|182865894|SUPERIORITY||Risk Difference (RD)|8.63|STANDARD_ERROR_OF_MEAN|8.78||0.3258|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.3258
91497765|NCT05355805|182865894|SUPERIORITY||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.775||0.4068|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.4068
91513571|NCT02673697|182898989|NON_INFERIORITY|"The primary analysis will calculate the Bayesian posterior probability that the difference \[MACCECONTROL~\- MACCEPERCEVAL\] is lower than 0.05 (predetermined non-inferiority margin): The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis."||||||0.9914||||||The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis.|Bayesian|||"A the primary analysis will compare Perceval valve (Treatment arm) vs. standard sutured stented valve (Control arm) on the Per Protocol population.~A one-sided non-inferiority test, using the non-inferiority margin Δ=0.05, will be performed to compare the two arms on the proportion of subjects that are event-free at one year (primary analysis)."||||0.9914
91704130|NCT01149421|183302244|SUPERIORITY_OR_OTHER|||||||0.972||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.972
91736339|NCT03189719|183365746|OTHER||Difference in LS Means|-4.49||||0.1632|TWO_SIDED|95.0|-10.81|1.83|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.83|-10.81|0.1632
91513572|NCT00289341|182898995|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||for injection site reaction only||||0.001
91704131|NCT01149421|183302244|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.904
91704132|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.17|3.8||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||3.80|1.17|<0.001
91704133|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.08|TWO_SIDED|95.0|-0.14|2.45||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||2.45|-0.14|0.080
91704134|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.23|4.91||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||4.91|2.23|<0.001
91704135|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92||||0.168|TWO_SIDED|95.0|-0.39|2.24||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||2.24|-0.39|0.168
91704136|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||<|0.001|TWO_SIDED|95.0|2.62|5.28||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||5.28|2.62|<0.001
91704137|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78|||<|0.001|TWO_SIDED|95.0|1.47|4.09||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||4.09|1.47|<0.001
91704138|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.49|5.47||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||5.47|2.49|<0.001
91704139|NCT01149421|183302245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.003|TWO_SIDED|95.0|0.78|3.7||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||3.70|0.78|0.003
91704140|NCT01149421|183302245|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||<0.001
91704141|NCT01149421|183302245|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||0.014
91736340|NCT03189719|183365746|OTHER||Difference in LS Means|-1.71||||0.3259|TWO_SIDED|95.0|-5.12|1.71|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.71|-5.12|0.3259
91704142|NCT01149421|183302245|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||<0.001
91704143|NCT01149421|183302245|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||0.005
91704144|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-4.5|-2.43||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-2.43|-4.50|<0.001
91497766|NCT05355805|182865895|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|-7.4|STANDARD_ERROR_OF_MEAN|7.661||0.3329|TWO_SIDED|||||The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.3329
91736341|NCT03189719|183365746|OTHER||Difference in LS Means|-1.5||||0.4598|TWO_SIDED|95.0|-5.47|2.48|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.48|-5.47|0.4598
91736342|NCT03189719|183365747|OTHER||Difference in LS Means|-8.2||||0.0317|TWO_SIDED|95.0|-15.67|-0.73|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||-0.73|-15.67|0.0317
91736343|NCT03189719|183365747|OTHER||Difference in LS Means|-3.57||||0.0945|TWO_SIDED|95.0|-7.77|0.62|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.62|-7.77|0.0945
91736344|NCT03189719|183365747|OTHER||Difference in LS Means|-4.76||||0.0555|TWO_SIDED|95.0|-9.64|0.11|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.11|-9.64|0.0555
91736345|NCT05211596|183365759|SUPERIORITY||Mean Difference (Net)|0.43||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
91736346|NCT05211596|183365760|SUPERIORITY||Mean Difference (Net)|0.22||||0.264|TWO_SIDED||||||t-test, 2 sided|||||||0.264
91736347|NCT05211596|183365761|SUPERIORITY||Mean Difference (Net)|849.35||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
91736348|NCT05211596|183365762|SUPERIORITY||Mean Difference (Net)|777.42||||0.054|TWO_SIDED||||||t-test, 2 sided|||||||0.054
91736349|NCT05211596|183365763|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91497767|NCT05355805|182865895|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|4.06|STANDARD_ERROR_OF_MEAN|7.574||0.5882|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.5882
91513573|NCT00289341|182898995|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||Fisher Exact|||for all other adverse events||||>0.2
91736350|NCT05211596|183365764|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91736351|NCT02293551|183365765|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Squares Mean|1.04||||0.2071|TWO_SIDED|90.0|0.988|1.1|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.10|0.988|0.2071
91736352|NCT02293551|183365765|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.11||||0.0005|TWO_SIDED|90.0|1.06|1.17|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.17|1.06|0.0005
91736353|NCT02293551|183365765|SUPERIORITY_OR_OTHER_LEGACY||Geometric of Ratio Least Square Means|1.08||||0.0123|TWO_SIDED|90.0|1.03|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.03|0.0123
91513574|NCT00289341|182898997|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Linear Spline model|||||||0.016
91736354|NCT02293551|183365765|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.07||||0.0331|TWO_SIDED|90.0|1.02|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.02|0.0331
91736355|NCT02293551|183365765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||Dose proportionality and the degree of dose proportionality was assessed by fitting the power model versus dose. Estimated ratio of dose-normalized geometric means of PK parameters between the highest and lowest doses assessed dose proportionality.|||1.16|1.06|
91736356|NCT04532749|183365766|SUPERIORITY||Least square (LS) mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.43|=|0.411|TWO_SIDED|95.0|-4.0|1.64|||Mixed Model Repeated Measures (MMRM)|||||1.64|-4.00|=0.411
91497768|NCT05355805|182865896|SUPERIORITY||Risk Difference (RD)|7.31|STANDARD_ERROR_OF_MEAN|11.995||0.5422|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.5422
91497769|NCT05355805|182865896|SUPERIORITY||Risk Difference (RD)|-5.23|STANDARD_ERROR_OF_MEAN|11.77||0.6569|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.6569
91736357|NCT04532749|183365767|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.27|=|0.473|TWO_SIDED|95.0|-3.41|1.59|||MMRM model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the first secondary endpoint (MADRS-WOSI) and thus, a formal statistical testing was not performed.||1.59|-3.41|=0.473
91736358|NCT04532749|183365768|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45|=|0.167|TWO_SIDED|95.0|-4.87|0.85|||MMRM Model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the second secondary endpoint (PROMIS-SD; Short Form 8a) and thus, a formal statistical testing was not performed.||0.85|-4.87|=0.167
91736359|NCT05395338|183365772|OTHER|cox proportional hazards models with stratification by matching pairs|Hazard Ratio (HR)|0.9||||0.183|TWO_SIDED|95.0|0.78|1.05|||Regression, Cox||rt-PA/non reperfusion|||1.05|0.78|0.183
91736360|NCT05395338|183365773|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.39|||Regression, Logistic|||||1.39|1.12|<0.001
91736361|NCT05395338|183365774|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.23|||<|0.001|TWO_SIDED|95.0|1.11|1.36|||Regression, Logistic||rt-PA/non reperfusion|||1.36|1.11|<0.001
91736362|NCT05395338|183365775|OTHER|Conditional logistic regression models with stratification by matching pairs|Odds Ratio (OR)|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.83|||Regression, Logistic||rt-PA/non reperfusion|||0.83|0.64|<0.001
91497770|NCT05355805|182865897|SUPERIORITY||Risk Difference (RD)|7.48|STANDARD_ERROR_OF_MEAN|8.951||0.4031|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.4031
91513575|NCT03893448|182898998|OTHER||Percentage Point Difference|-4.8|||=|0.039|TWO_SIDED|95.0|-9.3|-0.2|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-9.3|= 0.039
91513576|NCT03893448|182898998|OTHER||Percentage Point Difference|-0.4|||=|0.836|TWO_SIDED|95.0|-4.6|3.7|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||3.7|-4.6|= 0.836
91513577|NCT03893448|182898998|OTHER||Percentage Point Difference|2.9|||=|0.235|TWO_SIDED|95.0|-1.9|7.6|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||7.6|-1.9|= 0.235
91736363|NCT05395338|183365776|OTHER|Ordinal logistic regression models|Odds Ratio (OR)|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.93|||Regression, Logistic||rt-PA/non reperfusion|||0.93|0.77|<0.001
91736364|NCT00069641|183365784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.96|STANDARD_ERROR_OF_MEAN|6.47||0.0049|TWO_SIDED|95.0|5.99|31.93|||ANCOVA|||p-value for treatment difference based on Analysis of covariance (ANCOVA) model containing treatment, region, baseline participant age, and baseline disease score.||31.93|5.99|0.0049
91736365|NCT00492557|183365798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% confidence interval (CI), computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|1.7|||||TWO_SIDED|95.0|-3.1|6.5||||||Influenza virus subtype: A/H1N1. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||6.5|-3.1|
91736366|NCT00492557|183365798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-4.6|||||TWO_SIDED|95.0|-10.4|1.3||||||Influenza virus subtype: A/H3N2. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||1.3|-10.4|
91736367|NCT00492557|183365798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-7.8|4.1||||||Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||4.1|-7.8|
91497771|NCT05355805|182865897|SUPERIORITY||Risk Difference (RD)|21.27|STANDARD_ERROR_OF_MEAN|9.959||0.0327|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.0327
91497772|NCT00534430|182865903|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Log Rank|No adjustments.||Log-rank test. (Mantel-Haenszel test). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing.||||>0.05
91530838|NCT03844321|182937756|SUPERIORITY|||||||0.333||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.333
91736368|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.6|1.04|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.04|0.60|
91736369|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.78|1.13|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.13|0.78|
91736370|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.66|||||TWO_SIDED|95.0|0.51|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.51|
91736371|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.55|0.86|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.86|0.55|
91736372|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.76|||||TWO_SIDED|95.0|0.61|0.94|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.94|0.61|
91736373|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.75|1.25|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.25|0.75|
91736374|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.07|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.07|0.67|
91736375|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.02|0.63|
91760048|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.78|-0.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-0.78|
91497773|NCT00534430|182865904|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Gray's Test|No adjustments.||Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing||||>0.05
91497774|NCT02423577|182865905|SUPERIORITY||Risk Ratio (RR)|1.14||||0.1436|TWO_SIDED|90.0|0.98|1.31|||Chi-squared|||||1.31|0.98|0.1436
91497775|NCT01986855|182865906|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.807|TWO_SIDED|95.0|-0.23|0.18||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.18|-0.23|0.807
91497776|NCT01986855|182865906|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.15||||0.155|TWO_SIDED|95.0|-0.35|0.06||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.06|-0.35|0.155
91497777|NCT01986855|182865907|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.6|||||TWO_SIDED|95.0|-4.8|12.1|||||Miettinen \& Nurminen Method|||12.1|-4.8|
91497778|NCT01986855|182865907|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-7.0|||||TWO_SIDED|95.0|-16.3|2.3|||||Miettinen \& Nurminen Method|||2.3|-16.3|
91497779|NCT01986855|182865908|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.0|||||TWO_SIDED|95.0|-2.7|9.0|||||Miettinen \& Nurminen Method|||9.0|-2.7|
91497780|NCT01986855|182865908|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-1.3|||||TWO_SIDED|95.0|-6.5|3.7|||||Miettinen \& Nurminen Method|||3.7|-6.5|
91497781|NCT01986855|182865909|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.828|TWO_SIDED|95.0|-0.28|0.23||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.23|-0.28|0.828
91530839|NCT03844321|182937757|SUPERIORITY|||||||0.224||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.224
91497782|NCT01986855|182865909|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.09||||0.496|TWO_SIDED|95.0|-0.35|0.17||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.17|-0.35|0.496
91497783|NCT01986855|182865910|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||<|0.001|TWO_SIDED|95.0|-2.57|-0.96||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-0.96|-2.57|<0.001
91497784|NCT01986855|182865910|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.84|||<|0.001|TWO_SIDED|95.0|-2.66|-1.02||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-1.02|-2.66|<0.001
91497785|NCT01986855|182865911|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.42||||0.451|TWO_SIDED|95.0|-5.13|2.29||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||2.29|-5.13|0.451
91497786|NCT01986855|182865911|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.46||||0.072|TWO_SIDED|95.0|-7.24|0.31||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.31|-7.24|0.072
91497787|NCT01986855|182865912|SUPERIORITY_OR_OTHER||Difference in the least squares means|-6.81||||0.291|TWO_SIDED|96.0|-19.47|5.85||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.85|-19.47|0.291
91497788|NCT01986855|182865912|SUPERIORITY_OR_OTHER||Difference in the least squares means|-15.51||||0.019|TWO_SIDED|95.0|-28.5|-2.53||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-2.53|-28.50|0.019
91704145|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-2.79|-0.75||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-0.75|-2.79|<0.001
91497789|NCT01986855|182865913|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.16||||0.713|TWO_SIDED|95.0|0.53|2.56||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.56|0.53|0.713
91497790|NCT01986855|182865913|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.06||||0.89|TWO_SIDED|95.0|0.44|2.55||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.55|0.44|0.890
91704146|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|-4.52|-2.28||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-2.28|-4.52|<0.001
91736376|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.72|||||TWO_SIDED|95.0|0.53|0.97|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.97|0.53|
91736377|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.64|1.01|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.01|0.64|
91736378|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.7|||||TWO_SIDED|95.0|0.56|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.56|
91736379|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.85|0.49|
91736380|NCT00492557|183365799|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.71|1.27|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.71|
91736381|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.68|
91736382|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.2|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.20|0.69|
91736383|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|0.95|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.95|0.47|
91736384|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.77|1.6|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.60|0.77|
91736385|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.08|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.08|0.54|
91497791|NCT02014597|182865924|OTHER|||||||0.0583||||||Scotopic logCS|Kruskal-Wallis|||||||0.0583
91497792|NCT02014597|182865924|OTHER|||||||0.1762||||||Photopic logCS|Kruskal-Wallis|||||||0.1762
91497793|NCT02014597|182865925|OTHER|||||||0.183||||||Scotopic|Pearson correlation|||Correlation between logCS and MD.||||0.183
91497794|NCT02014597|182865925|OTHER|||||||0.771||||||Photopic|Pearson correlation|||Correlation between logCS and MD.||||0.771
91497795|NCT02014597|182865925|OTHER|||||||0.492||||||Scotopic|Pearson correlation|||Correlation between logCS and PSD.||||0.492
91497796|NCT02014597|182865925|OTHER|||||||0.83||||||Photopic|Pearson correlation|||Correlation between logCS and PSD.||||0.830
91704147|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|||<|0.001|TWO_SIDED|95.0|-3.23|-1.03||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.03|-3.23|<0.001
91704148|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|95.0|-3.43|-1.07||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-1.07|-3.43|<0.001
91704149|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.113|TWO_SIDED|95.0|-2.09|0.22||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||0.22|-2.09|0.113
91704150|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|||<|0.001|TWO_SIDED|95.0|-3.86|-1.62||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.62|-3.86|<0.001
91704151|NCT01149421|183302246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.004|TWO_SIDED|95.0|-2.72|-0.51||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-0.51|-2.72|0.004
91704152|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.128|TWO_SIDED|95.0|-2.22|0.28||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||0.28|-2.22|0.128
91704153|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.883|TWO_SIDED|95.0|-1.32|1.13||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.13|-1.32|0.883
91704154|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.39|TWO_SIDED|95.0|-1.84|0.72||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.72|-1.84|0.390
91736386|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.55|1.09|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.09|0.55|
91497797|NCT00754624|182865960|SUPERIORITY_OR_OTHER||Slope|-0.048|||||TWO_SIDED|95.0|-0.059|-0.037|||Random coefficient|Adjusted for Baseline FEV1 value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FEV1 data to estimate the annual rate of decline. The model included terms for baseline FEV1 and time (in years) of FEV1 measurements. Missing pulmonary functions were not imputed.||-0.037|-0.059|
91497798|NCT00754624|182865961|SUPERIORITY_OR_OTHER||Slope|-0.058|||||TWO_SIDED|95.0|-0.072|-0.043|||Random Coefficient|Adjusted for Baseline FVC value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FVC data to estimate the annual rate of decline. The model included terms for baseline FVC and time (in years) of FVC measurements. Missing pulmonary functions were not imputed.||-0.043|-0.072|
91704155|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.463|TWO_SIDED|95.0|-1.72|0.79||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.79|-1.72|0.463
91704156|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.671|TWO_SIDED|95.0|-1.13|1.76||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.76|-1.13|0.671
91704157|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.471|TWO_SIDED|95.0|-0.9|1.95||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.95|-0.90|0.471
91704158|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.543|TWO_SIDED|95.0|-1.95|1.03||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.03|-1.95|0.543
91704159|NCT01149421|183302247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.728|TWO_SIDED|95.0|-1.72|1.2||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.20|-1.72|0.728
91704160|NCT01149421|183302260|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||<0.001
91704161|NCT01149421|183302260|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||0.005
91704162|NCT01149421|183302260|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||<0.001
91704163|NCT01149421|183302260|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.012
91704164|NCT04108988|183302266|SUPERIORITY|||||||0.248|||||||Chi-squared|||P value at 4 months||||0.248
91704165|NCT04108988|183302266|SUPERIORITY|||||||0.022|||||||Chi-squared|||P value at 1 month||||0.022
91704166|NCT04108988|183302266|SUPERIORITY|||||||0.193|||||||Chi-squared|||P value at baseline||||0.193
91704167|NCT04108988|183302267|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at 4 months||||0.246
91704168|NCT04108988|183302267|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at 1 month||||0.467
91704169|NCT04108988|183302267|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline||||0.550
91704170|NCT04108988|183302268|SUPERIORITY|||||||0.596|||||||Chi-squared|||P value at month 4||||0.596
91704171|NCT04108988|183302268|SUPERIORITY|||||||0.974|||||||Chi-squared|||P value at 1 month||||0.974
91704172|NCT04108988|183302268|SUPERIORITY|||||||0.651|||||||Chi-squared|||P value at baseline.||||0.651
91704173|NCT04108988|183302269|SUPERIORITY|||||||0.089|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.089
91704174|NCT04108988|183302270|SUPERIORITY|||||||0.095|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.095
91704175|NCT04108988|183302271|SUPERIORITY|||||||0.136|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.136
91704176|NCT04108988|183302272|SUPERIORITY|||||||0.133|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.133
91497799|NCT00754624|182865962|SUPERIORITY_OR_OTHER||Slope|-0.311|||||TWO_SIDED|95.0|-0.454|-0.168|||Random Coefficient|Adjusted for Baseline DLCo value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed DLco data to estimate the annual rate of decline. The model included terms for baseline DLco and time (in years) of DLco measurements. Missing pulmonary functions were not imputed.||-0.168|-0.454|
91497800|NCT01571427|182865967|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.35||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.25
91497801|NCT01571427|182865967|EQUIVALENCE|Power calculation was based on the entire sample (CDR=0 and CDR=0.5 combined). Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.25
91497802|NCT01571427|182865967|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.62||0.85|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: AMONG CDR=0.5 (Mild Cognitive Impairment) group, N=34 .||||0.85
91497803|NCT01571427|182865968|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.92||0.02|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.02
91704177|NCT04108988|183302273|SUPERIORITY|||||||0.21|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.210
91704178|NCT04108988|183302274|SUPERIORITY|||||||0.392|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.392
91704179|NCT04108988|183302275|SUPERIORITY|||||||0.411|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.411
91704180|NCT04108988|183302276|SUPERIORITY|||||||0.294|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.294
91704181|NCT04108988|183302277|SUPERIORITY|||||||0.031|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.031
91704182|NCT04108988|183302278|SUPERIORITY|||||||0.262|||||||ANOVA|Test for the interaction between treatment and time||Test of interaction with treatment and time.||||0.262
91704183|NCT04108988|183302279|SUPERIORITY|||||||0.116|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.116
91704184|NCT04108988|183302280|SUPERIORITY|||||||0.016|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.016
91704185|NCT04108988|183302281|SUPERIORITY|||||||0.667|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.667
91704186|NCT04108988|183302282|SUPERIORITY|||||||0.09|||||||Chi-squared|||P value at month 4||||0.09
91704187|NCT04108988|183302282|SUPERIORITY|||||||0.72|||||||Chi-squared|||P value 1 month||||0.72
91704188|NCT04108988|183302282|SUPERIORITY|||||||0.97|||||||Chi-squared|||P value at baseline||||0.97
91704189|NCT04108988|183302283|SUPERIORITY|||||||0.53|||||||Chi-squared|||P value at month 4||||0.53
91704190|NCT04108988|183302283|SUPERIORITY|||||||0.303|||||||Chi-squared|||P value at month 1||||0.303
91704191|NCT04108988|183302283|SUPERIORITY|||||||0.042|||||||Chi-squared|||P value at baseline.||||0.042
91704192|NCT04108988|183302284|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at month 4.||||0.246
91704193|NCT04108988|183302284|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at month 1.||||0.467
91704194|NCT04108988|183302284|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline.||||0.55
91704195|NCT04108988|183302285|SUPERIORITY|||||||0.987|||||||Chi-squared|||P value at month 4.||||0.987
91704196|NCT04108988|183302285|SUPERIORITY|||||||0.898|||||||Chi-squared|||P value at month 1.||||0.898
91704197|NCT04108988|183302285|SUPERIORITY|||||||0.238|||||||Chi-squared|||P value at baseline.||||0.238
91704198|NCT04108988|183302286|SUPERIORITY|||||||0.148|||||||Chi-squared|||P value at month 4.||||0.148
91704199|NCT04108988|183302286|SUPERIORITY|||||||0.557|||||||Chi-squared|||P value at month 1.||||0.557
91704200|NCT04108988|183302287|SUPERIORITY|||||||0.653|||||||Chi-squared|||||||0.653
91704201|NCT04108988|183302288|SUPERIORITY|||||||0.977|||||||Chi-squared|||||||0.977
91704202|NCT04108988|183302289|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|||P value at month 4.||||0.735
91704203|NCT04108988|183302289|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||P value at month 1.||||0.159
91704204|NCT04108988|183302290|SUPERIORITY|||||||3.19|||||||t-test, 2 sided|||P value at month 4.||||3.19
91704205|NCT04108988|183302290|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||P value at month 1.||||0.487
91704206|NCT04108988|183302290|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||P value at baseline.||||0.165
91704207|NCT04108988|183302291|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||P value at month 4.||||0.473
91704208|NCT04108988|183302291|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||P value at month 1.||||0.316
91704209|NCT04108988|183302291|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||P value at baseline.||||0.345
91704210|NCT04108988|183302292|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||P value at month 4.||||0.141
91497804|NCT01571427|182865968|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.28||0.003|TWO_SIDED|||||Statistically significant based on the Bonferroni multiple comparison adjusted P value of P\<0.004.|Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.003
91497805|NCT01571427|182865968|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|1.14||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: CDR=0.5 (Mild Cognitive Impairment) group, N=34||||0.65
91497806|NCT01571427|182865969|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.33||0.98|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.98
91497807|NCT01571427|182865969|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|1.63||0.96|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: Among CDR 0 (n=49)||||0.96
91497808|NCT01571427|182865969|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.38||0.83|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: Among CDR 0.5 (n=34)||||0.83
91497809|NCT01571427|182865970|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.64||0.68|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.68
91704211|NCT04108988|183302292|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||P value at month 1.||||0.314
91704212|NCT04108988|183302292|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||P value at baseline.||||0.444
91704213|NCT04007107|183302452|OTHER|Comparison|Estimated treatment difference|30.7|||<|0.0001|TWO_SIDED|95.0|26.6|34.8|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||34.8|26.6|<0.0001
91736387|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.47|
91759505|NCT02391363|183411756|SUPERIORITY|||||||0.13||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.13
91497810|NCT01571427|182865970|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.84||0.69|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.69
91497811|NCT01571427|182865970|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.02||0.86|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.86
91704214|NCT00426660|183302476|SUPERIORITY_OR_OTHER||75th percentile (median)|169.0|||||TWO_SIDED|95.0|135.0|178.0||||||||178.0|135.0|
91704215|NCT00426660|183302476|SUPERIORITY_OR_OTHER||50th percentile (median)|86.5|||||TWO_SIDED|95.0|82.0|92.0||||||||92.0|82.0|
91704216|NCT00426660|183302476|SUPERIORITY_OR_OTHER||25th percentile (median)|58.0|||||TWO_SIDED|95.0|57.0|62.0||||||||62.0|57.0|
91704217|NCT03114657|183302481|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.633|||TWO_SIDED|95.0|0.0|2.6||||||||2.60|0.00|
91704218|NCT03114657|183302482|SUPERIORITY||Least Squares Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|2.028|||TWO_SIDED|95.0|-2.4|5.89||||||||5.89|-2.40|
91704219|NCT03114657|183302483|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|2.124|||TWO_SIDED|95.0|-4.03|4.68||||||||4.68|-4.03|
91497812|NCT01571427|182865971|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.43||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.92
91497813|NCT01571427|182865971|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.61||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.92
91497814|NCT01571427|182865971|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.62||0.94|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.94
91497815|NCT01571427|182865972|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.84||0.46|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.46
91497816|NCT01571427|182865972|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.08||0.61|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.61
91497817|NCT01571427|182865972|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|6.42||0.8|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.80
91497818|NCT01571427|182865973|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|8.88||0.72|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.72
91704220|NCT03114657|183302484|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.2|0.39||||||||0.39|-0.20|
91497819|NCT01571427|182865973|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|11.1||0.84|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.84
91497820|NCT01571427|182865973|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|12.39|STANDARD_ERROR_OF_MEAN|14.4||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
91497821|NCT01571427|182865974|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.91||0.38|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.38
91497822|NCT01571427|182865974|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.31||0.39|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.39
91513578|NCT03893448|182898998|OTHER||Percentage Point Difference|2.4|||=|0.26|TWO_SIDED|95.0|-1.7|6.5|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||6.5|-1.7|= 0.260
91704221|NCT03114657|183302485|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-2.42|1.6||||||||1.60|-2.42|
91704222|NCT03114657|183302486|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|3.052|||TWO_SIDED|95.0|-8.74|3.7||||||||3.70|-8.74|
91704223|NCT03114657|183302487|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|2.501|||TWO_SIDED|95.0|-6.29|3.92||||||||3.92|-6.29|
91704224|NCT03114657|183302488|SUPERIORITY||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-2.25|3.51||||||||3.51|-2.25|
91704225|NCT03114657|183302490|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.502|||TWO_SIDED|95.0|-1.75|0.23||||||||0.23|-1.75|
91497823|NCT01571427|182865974|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.26||0.59|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.59
91497824|NCT01571427|182865975|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.03|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.03
91497825|NCT01571427|182865975|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.24
91497826|NCT01571427|182865975|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.04
91497827|NCT01571427|182865976|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.65
91497828|NCT01571427|182865976|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.64
91497829|NCT01571427|182865976|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.42
91497830|NCT01571427|182865977|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.45||0.45|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.45
91497831|NCT01571427|182865977|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.05||0.93|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.93
91497832|NCT01571427|182865977|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
91497833|NCT01571427|182865978|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.30
91497834|NCT01571427|182865978|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.75|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.75
91513579|NCT03893448|182898999|OTHER||Percentage Point Difference|-1.8|||=|0.446|TWO_SIDED|95.0|-6.3|2.8|||Miettinen & Nurminen||V114-Prevnar 13™|Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.8|-6.3|= 0.446
91704226|NCT03114657|183302491|SUPERIORITY||Least Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|1.383|||TWO_SIDED|95.0|-3.3|2.39||||||||2.39|-3.30|
91704227|NCT03114657|183302492|SUPERIORITY||Least Squares Mean Difference|6.55|STANDARD_ERROR_OF_MEAN|5.527|||TWO_SIDED|95.0|-4.35|17.44||||||||17.44|-4.35|
91704228|NCT03114657|183302493|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|5.831|||TWO_SIDED|95.0|-12.31|11.71||||||||11.71|-12.31|
91497835|NCT01571427|182865978|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.15||0.12|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.12
91497836|NCT03590041|182866016|SUPERIORITY|||||||0.04||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in Patient-Driven SMAs would have greater reductions in Diabetes Distress than those in Standardized SMAs. We expected seeing an effect size of a .6 unit decrease (.30) in Standardized SMAs and 1.2 unit decrease (.60) in Patient-Driven SMAs. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.04
91497837|NCT03590041|182866017|SUPERIORITY|||||||0.82||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in the Patient-Driven condition would have a greater reduction in HbA1c than patients in the Standardized condition. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.82
91513580|NCT03893448|182898999|OTHER||Percentage Point Difference|1.0|||=|0.622|TWO_SIDED|95.0|-3.0|5.1|||Miettinen & Nurminen||V114-Prevnar 13™|Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||5.1|-3.0|= 0.622
91513581|NCT03893448|182898999|OTHER||Percentage Point Difference|-3.0|||=|0.202|TWO_SIDED|95.0|-7.6|1.6|||Miettinen & Nurminen||V114-Prevnar 13™|Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-7.6|= 0.202
91736388|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.42|1.03|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.03|0.42|
91736389|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.65|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.65|
91497838|NCT02254486|182866034|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|0.14||||0.528|ONE_SIDED|97.5|-8.15|||P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-8.15|0.528
91530840|NCT03844321|182937757|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.885
91704229|NCT03114657|183302494|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|3.94|||TWO_SIDED|95.0|-11.5|4.73||||||||4.73|-11.50|
91530841|NCT03844321|182937758|SUPERIORITY|||||||0.49||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.490
91704230|NCT03114657|183302500|SUPERIORITY||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.622|||TWO_SIDED|95.0|-2.01|0.89||||||||0.89|-2.01|
91704231|NCT03114657|183302501|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|95.0|-1.7|4.9||||||||4.90|-1.70|
91704232|NCT03114657|183302502|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|95.0|-1.13|0.41||||||||0.41|-1.13|
91704233|NCT04245202|183302503|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91704234|NCT04245202|183302504|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91704235|NCT04245202|183302505|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91736390|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.14|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.14|0.59|
91736391|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.61|
91760049|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||||TWO_SIDED|95.0|-1.12|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.12|
91704236|NCT04245202|183302506|OTHER||Mean Difference (Net)|-12.29|STANDARD_DEVIATION|5.72|<|0.001|TWO_SIDED|95.0|-23.53|-1.05||The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||-1.05|-23.53|<0.001
91704237|NCT04245202|183302507|OTHER||Mean Difference (Net)|-12.66|STANDARD_DEVIATION|4.77|<|0.001|TWO_SIDED|95.0|-22.05|-3.28|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.||-3.28|-22.05|<0.001
91704238|NCT04245202|183302508|OTHER||Mean Difference (Net)|-3.91|STANDARD_DEVIATION|2.43|<|0.001|TWO_SIDED|95.0|-8.68|0.86||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||0.86|-8.68|<0.001
91704239|NCT04245202|183302509|OTHER||Mean Difference (Net)|-2.41|STANDARD_DEVIATION|2.14||0.003|TWO_SIDED|95.0|-6.62|1.78|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.||1.78|-6.62|0.003
91704240|NCT04245202|183302510|OTHER||Relative treatment effect difference|-0.07||||0.002|TWO_SIDED|||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.002
91705649|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|1.17||0.972|TWO_SIDED|95.0|-2.34|2.25||P-value is for sexual relationship - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.25|-2.34|0.972
91704241|NCT04245202|183302511|OTHER||Relative treatment effect difference|-0.08||||0.001|TWO_SIDED|95.0||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.001
91704242|NCT04245202|183302513|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91704243|NCT04245202|183302514|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91704244|NCT04245202|183302515|OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
91736392|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.16|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.16|0.57|
91736393|NCT00492557|183365802|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.27|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.54|
91736394|NCT00372957|183365813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-2.28|-1.93|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||-1.93|-2.28|
91736395|NCT00372957|183365813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||||TWO_SIDED|95.0|-2.33|-1.98|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-1.98|-2.33|
91736396|NCT00372957|183365813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-2.15|-1.82|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||-1.82|-2.15|
91736397|NCT00372957|183365813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12|||||TWO_SIDED|95.0|-2.28|-1.95|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-1.95|-2.28|
91736398|NCT00372957|183365814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.87|||||TWO_SIDED|95.0|2.33|5.41|||Double-delta analysis||he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||5.41|2.33|
91736399|NCT00372957|183365814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|3.7|6.73|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||6.73|3.70|
91736400|NCT00372957|183365814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||||TWO_SIDED|95.0|1.9|4.54|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||4.54|1.90|
91736401|NCT00372957|183365814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.39|||||TWO_SIDED|95.0|3.1|5.68|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.68|3.10|
91736402|NCT00372957|183365815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|||||TWO_SIDED|95.0|-6.0|2.89|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||2.89|-6.00|
91736403|NCT00372957|183365815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||||TWO_SIDED|95.0|-3.3|5.72|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||5.72|-3.30|
91736404|NCT00372957|183365815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.2|2.5|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||2.50|-5.20|
91736405|NCT00372957|183365815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|-2.47|5.43|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.43|-2.47|
91736406|NCT00372957|183365816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-20.4|4.2|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||4.2|-20.4|
91736407|NCT00372957|183365816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||||TWO_SIDED|95.0|-28.4|-3.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-3.9|-28.4|
91704245|NCT04245202|183302516|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
91736408|NCT00372957|183365816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||||TWO_SIDED|95.0|-23.1|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-23.1|
91736409|NCT00372957|183365816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-27.9|-3.3|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-3.3|-27.9|
91704246|NCT04245202|183302517|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
91704247|NCT04245202|183302518|OTHER|||||||0.08|||||||Fisher Exact|||||||0.08
91704248|NCT01153620|183302522|SUPERIORITY_OR_OTHER||||||=|0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.006
91704249|NCT03878875|183302596|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|116.044|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = -2.153.||||||< 0.0005
91497839|NCT02254486|182866035|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|6.58||||0.059|ONE_SIDED|97.5|-1.69|||P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value \<0.025; the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-1.69|0.059
91530842|NCT03844321|182937758|SUPERIORITY|||||||0.266||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.266
91736410|NCT00372957|183365817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.64|1.16|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||1.16|-0.64|
91736411|NCT00372957|183365817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-0.47|1.32|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||1.32|-0.47|
91736412|NCT00372957|183365817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.37|1.07|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.07|-0.37|
91736413|NCT00372957|183365817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|-0.24|1.21|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||1.21|-0.24|
91736414|NCT00372957|183365818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|||||TWO_SIDED|95.0|-40.7|0.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||0.9|-40.7|
91736415|NCT00372957|183365818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||||TWO_SIDED|95.0|-29.8|11.7|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||11.7|-29.8|
91736416|NCT00372957|183365818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||||TWO_SIDED|95.0|-33.2|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-33.2|
91736417|NCT00372957|183365818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-23.4|11.1|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||11.1|-23.4|
91736418|NCT04778592|183365820|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.291||0.4549|TWO_SIDED|95.0|-0.36|0.79|||Mixed Models Analysis|||||0.79|-0.36|0.4549
91736419|NCT05173974|183365840|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.037|TWO_SIDED|95.0|0.01|0.29||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|||0.29|0.01|0.037
91736420|NCT05173974|183365840|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.044|TWO_SIDED|95.0|0.0|0.28||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participant included as a random effect.|||0.28|0.00|0.044
91736421|NCT05173974|183365840|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.005|TWO_SIDED|95.0|0.06|0.3||unadjusted P-value was presented.|ANCOVA||||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|0.30|0.06|0.005
91736422|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.218|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.17|-0.04|0.218
91736423|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.034|TWO_SIDED|95.0|0.01|0.21|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.21|0.01|0.034
91736424|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.004|TWO_SIDED|95.0|0.05|0.25|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.25|0.05|0.004
91736425|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.058|TWO_SIDED|95.0|0.0|0.24|||ANCOVA||Statistical comparison for AOB 0-1|||0.24|-0.00|0.058
91736426|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.017|TWO_SIDED|95.0|0.03|0.27|||ANCOVA||Statistical comparison for AOB 0-1|||0.27|0.03|0.017
91736427|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.001|TWO_SIDED|95.0|0.09|0.33|||ANCOVA||Statistical comparison for AOB 0-1|||0.33|0.09|0.001
91736428|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.004|TWO_SIDED|95.0|0.06|0.3|||ANCOVA||Statistical comparison for AOB 0-3|||0.30|0.06|0.004
91736429|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.01|TWO_SIDED|95.0|0.04|0.27|||ANCOVA||Statistical comparison for AOB0-3|||0.27|0.04|0.010
91736430|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.31|||ANCOVA||Statistical comparison for AOB0-3|||0.31|0.07|0.002
91736431|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.022|TWO_SIDED|95.0|0.02|0.29|||ANCOVA||Statistical comparison for AOB 0-6|||0.29|0.02|0.022
91736432|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.011|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-6|||0.30|0.04|0.011
91497840|NCT02254486|182866036|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-3.01||||0.863|TWO_SIDED|95.0|-11.36|5.28||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||5.28|-11.36|0.863
91497841|NCT02254486|182866037|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.66||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.660
91497842|NCT02254486|182866038|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.953||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.953
91497843|NCT02254486|182866039|NON_INFERIORITY_OR_EQUIVALENCE|Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.||||||0.781|||||||Fisher Exact|||If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||||0.781
91497844|NCT01493570|182866050|OTHER||Ratio CSF to Plasma in %|28.31||||1|TWO_SIDED|90.0|25.418|31.532||p-value for ratio outside interval 80% - 125%|ANOVA||Intra Individual geometric coefficient of variation (gCV \[%\]) = 17.50 .|Dose-adjusted CSF to plasma ratio for Cmax. The Analysis of Variance (ANOVA) model was used with 'subject nested within treatment' considered as random effect.||31.532|25.418|1.0000
91497845|NCT00267046|182866058|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fine and Gray method.|||||||<0.001
91497846|NCT02772081|182866063|SUPERIORITY||Adjusted difference|-15.4||||0.39|TWO_SIDED|95.0|-47.9|17.1|||Cochran-Mantel-Haenszel|||First Administration; Treatment comparison. Adjusted difference, its 95% confidence interval (CI) and p-value are estimated using Cochran-Mantel-Haenszel test||17.1|-47.9|0.390
91497847|NCT02772081|182866069|SUPERIORITY||Median Difference (Final Values)|5.0||||0.563|TWO_SIDED|95.0|-13.8|23.8|||Wilcoxon (Mann-Whitney)|||Duration of standalone oxygen supplementation||23.8|-13.8|0.563
91497848|NCT02772081|182866069|SUPERIORITY||Median Difference (Final Values)|1.0||||0.612|TWO_SIDED|95.0|-19.7|21.7|||Wilcoxon (Mann-Whitney)|||Duration of NIV||21.7|-19.7|0.612
91497849|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|-0.619||||0.137|TWO_SIDED|95.0|-1.447|0.21|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an mixed model for repeated measures (MMRM) with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.210|-1.447|0.137
91497850|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.268||||0.534|TWO_SIDED|95.0|-0.604|1.14|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.140|-0.604|0.534
91513582|NCT03893448|182898999|OTHER||Percentage Point Difference|0.0|||=|0.985|TWO_SIDED|95.0|-2.4|2.3|||Miettinen & Nurminen||V114-Prevnar 13™|Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.3|-2.4|= 0.985
91513583|NCT03893448|182899000|OTHER||Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||V114-Prevnar 13™|Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.4|-0.4|
91513584|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.8|-5.2|< 0.001
91513585|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
91704250|NCT03878875|183302597|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|12.839|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = 1.602.||||||< 0.0005
91704251|NCT03878875|183302598|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|8.391|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient was 1.059.||||||< 0.0005
91704252|NCT03878875|183302599|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|6.416|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was 0.635.||||||< 0.001
91704253|NCT03878875|183302600|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|5.805|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was -0.383.||||||< 0.001
91704254|NCT03878875|183302601|SUPERIORITY|A binary logistic regression was employed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure.|Odds Ratio (OR)|1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.005|TWO_SIDED|95.0|1.071|1.85|||Regression, Logistic|||||1.85|1.071|< 0.005
91704255|NCT00337779|183302613|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0732|STANDARD_ERROR_OF_MEAN|0.1013||0.4859|TWO_SIDED|95.0|0.8799|1.309|||Regression, Poisson||980 subjects randomized into two arms provide approximately 90% power to detect significant difference between groups of 30% or more in rate of confirmed relapses.|||1.3090|0.8799|0.4859
91704256|NCT02028169|183302644|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704257|NCT02028169|183302645|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704258|NCT02028169|183302646|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline Vs. Month 9||||< 0.001
91704259|NCT02028169|183302647|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704260|NCT02028169|183302648|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704261|NCT02028169|183302648|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704262|NCT02028169|183302648|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91497851|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.27||||0.53|TWO_SIDED|95.0|-0.597|1.136|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.136|-0.597|0.530
91704263|NCT02028169|183302651|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704264|NCT02028169|183302651|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704265|NCT02028169|183302651|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704266|NCT02028169|183302652|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704267|NCT02028169|183302652|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704268|NCT02028169|183302652|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704269|NCT02028169|183302653|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704270|NCT02028169|183302654|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704271|NCT02028169|183302654|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704272|NCT02028169|183302654|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704273|NCT02028169|183302656|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704274|NCT02028169|183302658|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704275|NCT02028169|183302658|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704276|NCT02028169|183302658|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704277|NCT02028169|183302659|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704278|NCT02028169|183302659|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704279|NCT02028169|183302659|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704280|NCT02028169|183302660|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704281|NCT02028169|183302660|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704282|NCT02028169|183302660|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704283|NCT02028169|183302661|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704284|NCT02028169|183302661|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704285|NCT02028169|183302661|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91497852|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.641||||0.091|TWO_SIDED|95.0|-0.108|1.389|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.389|-0.108|0.091
91736433|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.33|||ANCOVA||Statistical comparison for AOB 0-6|||0.33|0.06|0.005
91497853|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.463||||0.04|TWO_SIDED|95.0|0.023|0.903|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.903|0.023|0.040
91497854|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.166||||0.532|TWO_SIDED|95.0|-0.371|0.703|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.703|-0.371|0.532
91497855|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.048||||0.877|TWO_SIDED|95.0|-0.578|0.674|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.674|-0.578|0.877
91704286|NCT02028169|183302662|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
91704287|NCT02028169|183302662|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
91704288|NCT02028169|183302662|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
91704289|NCT02240069|183302690|SUPERIORITY||Mean Difference (Net)|-0.11||||0.1|TWO_SIDED|95.0|-0.24|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Education group relative to Placebo group||0.02|-0.24|0.10
91704290|NCT02240069|183302690|SUPERIORITY||Mean Difference (Net)|0.01||||0.9|TWO_SIDED|95.0|-0.11|0.13|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group||0.13|-0.11|0.90
91704291|NCT02240069|183302691|SUPERIORITY||Mean Difference (Net)|-0.09||||0.28|TWO_SIDED|95.0|-0.24|0.07|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Education group relative to Placebo group||0.07|-0.24|0.28
91704292|NCT02240069|183302691|SUPERIORITY||Mean Difference (Net)|0.01||||0.89|TWO_SIDED|95.0|-0.14|0.16|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Filter group relative to Placebo group||0.16|-0.14|0.89
91704293|NCT02240069|183302692|SUPERIORITY||Mean Difference (Net)|-0.02||||0.06|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group||0.00|-0.05|0.06
91704294|NCT02240069|183302692|SUPERIORITY||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group||0.02|-0.03|0.71
91704295|NCT02240069|183302693|SUPERIORITY||Mean Difference (Net)|-3.46||||0.39|TWO_SIDED|95.0|-11.45|4.54|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group||4.54|-11.45|0.39
91704296|NCT02240069|183302693|SUPERIORITY||Mean Difference (Net)|0.25||||0.95|TWO_SIDED|95.0|-7.73|8.24|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group||8.24|-7.73|0.95
91704297|NCT02240069|183302694|SUPERIORITY||Mean Difference (Net)|-1.0||||0.65|TWO_SIDED|95.0|-5.42|3.42|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group||3.42|-5.42|0.65
91704298|NCT02240069|183302694|SUPERIORITY||Mean Difference (Net)|-0.58||||0.79|TWO_SIDED|95.0|-4.97|3.81|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group||3.81|-4.97|0.79
91704299|NCT02240069|183302695|SUPERIORITY||Mean Difference (Net)|-2.9||||0.88|TWO_SIDED|95.0|-33.6|42.0|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group||42.0|-33.6|0.88
91704300|NCT02240069|183302695|SUPERIORITY||Mean Difference (Net)|-50.5|||<|0.001|TWO_SIDED|95.0|-66.1|-27.8|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group||-27.8|-66.1|<0.001
91704301|NCT02227368|183302710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.3441|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.1|-0.4|0.3441
91704302|NCT02227368|183302711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.6186|TWO_SIDED|95.0|-0.4|0.6|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.6|-0.4|0.6186
91704303|NCT03046056|183302716|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-16.5|32.1||||||||32.1|-16.5|
91704304|NCT03046056|183302716|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-15.9|32.0||||||||32.0|-15.9|
91497856|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.244||||0.356|TWO_SIDED|95.0|-0.289|0.776|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.776|-0.289|0.356
91497857|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.303||||0.258|TWO_SIDED|95.0|-0.235|0.841|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.841|-0.235|0.258
91497858|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|0.022||||0.945|TWO_SIDED|95.0|-0.616|0.66|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.660|-0.616|0.945
91497859|NCT02772081|182866072|SUPERIORITY||Adjusted mean difference|-0.075||||0.766|TWO_SIDED|95.0|-0.586|0.436|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.436|-0.586|0.766
91497860|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|0.051||||0.59|TWO_SIDED|95.0|-0.141|0.243|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.243|-0.141|0.590
91497861|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.051||||0.511|TWO_SIDED|95.0|-0.21|0.107|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.107|-0.210|0.511
91530843|NCT03844321|182937759|SUPERIORITY|||||||0.928||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.928
91704305|NCT03046056|183302717|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-5.3|0.7||||||Difference in least squared means (Diff in LSM), and its 90% confidence interval (CI) were from analysis of covariance (ANCOVA) model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-5.3|
91704306|NCT03046056|183302717|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-2.7|3.1||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||3.1|-2.7|
91704307|NCT03046056|183302718|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-3.9|0.7||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-3.9|
91704308|NCT03046056|183302718|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-3.2|1.2||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||1.2|-3.2|
91704309|NCT03046056|183302719|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-2.2|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-2.2|
91704310|NCT03046056|183302719|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.9|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-1.9|
91736434|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.037|TWO_SIDED|95.0|0.01|0.27|||ANCOVA||Statistical comparison for AOB 0-9|||0.27|0.01|0.037
91497862|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.05||||0.488|TWO_SIDED|95.0|-0.196|0.096|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.096|-0.196|0.488
91497863|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.11||||0.091|TWO_SIDED|95.0|-0.239|0.019|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.019|-0.239|0.091
91497864|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.024||||0.344|TWO_SIDED|95.0|-0.076|0.027|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.027|-0.076|0.344
91497865|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.026||||0.376|TWO_SIDED|95.0|-0.084|0.033|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.033|-0.084|0.376
91704311|NCT03046056|183302720|SUPERIORITY||Risk Difference in Proportions|-1.7|||||TWO_SIDED|90.0|-28.6|25.5||||||||25.5|-28.6|
91704312|NCT03046056|183302720|SUPERIORITY||Risk Difference in Proportions|0.4|||||TWO_SIDED|90.0|-24.5|26.2||||||||26.2|-24.5|
91704313|NCT03046056|183302721|SUPERIORITY||Risk Difference in Proportions|-6.7|||||TWO_SIDED|90.0|-47.3|37.0||||||||37.0|-47.3|
91497866|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.04||||0.396|TWO_SIDED|95.0|-0.135|0.055|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.135|0.396
91497867|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.026||||0.268|TWO_SIDED|95.0|-0.074|0.021|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.021|-0.074|0.268
91497868|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.037||||0.147|TWO_SIDED|95.0|-0.089|0.014|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.014|-0.089|0.147
91497869|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.055|0.055|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.055|0.994
91497870|NCT02772081|182866073|SUPERIORITY||Adjusted mean difference|-0.004||||0.853|TWO_SIDED|95.0|-0.048|0.04|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.040|-0.048|0.853
91497871|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|-10.4||||0.09|TWO_SIDED|95.0|-22.6|1.7|||Mixed model for repeated measures|||T0; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||1.7|-22.6|0.090
91704314|NCT03046056|183302721|SUPERIORITY||Risk Difference in Proportions|-16.7|||||TWO_SIDED|90.0|-58.2|30.0||||||||30.0|-58.2|
91704315|NCT03046056|183302722|SUPERIORITY||Risk Difference in Proportions|33.3|||||TWO_SIDED|90.0|-32.4|86.5||||||||86.5|-32.4|
91704316|NCT03046056|183302723|SUPERIORITY||Risk Difference in Proportions|-2.3|||||TWO_SIDED|90.0|-28.6|24.3||||||||24.3|-28.6|
91704317|NCT03046056|183302723|SUPERIORITY||Risk Difference in Proportions|-15.0|||||TWO_SIDED|90.0|-39.4|11.3||||||||11.3|-39.4|
91704318|NCT03046056|183302724|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-38.9|45.7||||||||45.7|-38.9|
91736435|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.013|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-9|||0.30|0.04|0.013
91497872|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|-0.3||||0.917|TWO_SIDED|95.0|-6.4|5.8|||Mixed model for repeated measures|||5 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.8|-6.4|0.917
91497873|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|-1.5||||0.668|TWO_SIDED|95.0|-8.5|5.6|||Mixed model for repeated measures|||15 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.6|-8.5|0.668
91497874|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|4.0||||0.149|TWO_SIDED|95.0|-1.5|9.6|||Mixed model for repeated measures|||30 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||9.6|-1.5|0.149
91497875|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|1.8||||0.318|TWO_SIDED|95.0|-1.9|5.5|||Mixed model for repeated measures|||1 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.5|-1.9|0.318
91497876|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|1.6||||0.148|TWO_SIDED|95.0|-0.6|3.7|||Wilcoxon (Mann-Whitney)|||6 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.7|-0.6|0.148
91497877|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|3.3||||0.333|TWO_SIDED|95.0|-3.6|10.2|||Mixed model for repeated measures|||12 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||10.2|-3.6|0.333
91704319|NCT03046056|183302724|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-47.5|40.8||||||||40.8|-47.5|
91704320|NCT03046056|183302725|SUPERIORITY||Risk Difference in Proportions|50.0|||||TWO_SIDED|90.0|-16.8|89.5||||||||89.5|-16.8|
91704321|NCT03046056|183302725|SUPERIORITY||Risk Difference in Proportions|12.5|||||TWO_SIDED|90.0|-46.1|63.3||||||||63.3|-46.1|
91704322|NCT03046056|183302726|SUPERIORITY||Risk Difference in Proportions|8.0|||||TWO_SIDED|90.0|-17.2|32.6||||||||32.6|-17.2|
91704323|NCT03046056|183302726|SUPERIORITY||Risk Difference in Proportions|6.3|||||TWO_SIDED|90.0|-18.1|30.2||||||||30.2|-18.1|
91704324|NCT03046056|183302727|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-22.1|28.1||||||||28.1|-22.1|
91704325|NCT03046056|183302727|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-28.1|20.3||||||||20.3|-28.1|
91704326|NCT03046056|183302728|SUPERIORITY||Risk Difference in Proportions|17.1|||||TWO_SIDED|90.0|-7.6|40.4||||||||40.4|-7.6|
91704327|NCT03046056|183302728|SUPERIORITY||Risk Difference in Proportions|2.8|||||TWO_SIDED|90.0|-21.2|26.5||||||||26.5|-21.2|
91704328|NCT03046056|183302729|SUPERIORITY||Least Squares Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|28.1|||TWO_SIDED|90.0|-95.0|-1.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||-1|-95|
91704329|NCT03046056|183302729|SUPERIORITY||Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|27.4|||TWO_SIDED|90.0|-76.0|15.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||15|-76|
91736436|NCT05173974|183365841|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.32|||ANCOVA||Statistical comparison for AOB 0-9|||0.32|0.06|0.005
91736437|NCT01453166|183365992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0|STANDARD_DEVIATION|19.0|<|0.05||95.0|100.0|140.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||140|100|<0.05
91736438|NCT01453166|183365993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.0|STANDARD_DEVIATION|15.0||0.05||95.0|66.0|95.0|||ANOVA|||||95|66|0.05
91736439|NCT01453166|183365994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|170.0|STANDARD_DEVIATION|39.0||0.05||95.0|140.0|220.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||220|140|0.05
91736440|NCT01453166|183365995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|12.0||0.05||95.0|88.0|112.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||112|88|0.05
91736441|NCT01453166|183365996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|30.0||0.05||95.0|77.0|137.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||137|77|0.05
91497878|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|0.9||||0.56|TWO_SIDED|95.0|-2.2|4.0|||Mixed model for repeated measures|||24 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.0|-2.2|0.560
91736442|NCT02727322|183365997|SUPERIORITY||Risk Ratio (RR)|1.1||||0.97|TWO_SIDED|95.0|0.5|2.04|||Chi-squared|||||2.04|0.50|0.97
91736443|NCT02727322|183365998|SUPERIORITY||Risk Ratio (RR)|1.12||||0.665|TWO_SIDED|95.0|0.885|1.43|||Chi-squared|||||1.43|0.885|0.665
91736444|NCT02727322|183365999|SUPERIORITY||Risk Ratio (RR)|1.32||||1|TWO_SIDED|95.0|0.31|5.68|||Fisher Exact|||||5.68|0.31|1.0
91736445|NCT01155050|183366022|SUPERIORITY|||||||0.296|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.296
91736446|NCT01155050|183366023|SUPERIORITY|||||||0.787|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.787
91736447|NCT01155050|183366024|SUPERIORITY|||||||0.34|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.340
91736448|NCT01155050|183366025|SUPERIORITY|||||||0.502|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.502
91736449|NCT01155050|183366026|SUPERIORITY|||||||0.86|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.860
91736450|NCT01155050|183366027|SUPERIORITY|||||||0.634|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.634
91736451|NCT01155050|183366028|SUPERIORITY|||||||0.879|||||||ANOVA|||The null hypothesis is that there is no difference in the outcome across the four treatment groups.||||.879
91736452|NCT01959529|183366035|NON_INFERIORITY|Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR\<1.3 was less than 2.5%.|Hazard Ratio (HR)|0.908|||<|0.001|TWO_SIDED|95.0|0.781|1.055||p value : Refers to one-sided test of HR \>= 1.3 (against Ha: HR\<1.3).|Regression, Cox|||The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.||1.055|0.781|<0.001
91736453|NCT01959529|183366036|SUPERIORITY||Rate ratio|0.601|||<|0.001|TWO_SIDED|95.0|0.476|0.759||p-value : Refers to one-sided test of RR \>= 1.0 (against Ha: RR\<1.0)|Negative binomial regression|The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS.||Superiority was considered confirmed if the upper limit of the two-sided 95% confidence interval for the rate ratio (RR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: RR ≥1.0 against Ha: RR \<1.0, was less than 2.5%||0.759|0.476|<0.001
91497879|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|2.0||||0.089|TWO_SIDED|95.0|-0.3|4.3|||Mixed model for repeated measures|||48 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.3|-0.3|0.089
91497880|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|1.9||||0.115|TWO_SIDED|95.0|-0.5|4.4|||Mixed model for repeated measures|||72 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.4|-0.5|0.115
91736454|NCT01959529|183366037|SUPERIORITY||Odds Ratio (OR)|0.729|||<|0.001|TWO_SIDED|95.0|0.6|0.866||p-value: Refers to one-sided test of OR \>= 1.0 (against Ha: OR\<1.0)|Regression, Logistic|The model was logistic regression with log-link function.The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS||Superiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the odds ratio (OR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: OR ≥1.0 against Ha: OR\<1.0, was less than 2.5%.||0.866|0.600|<0.001
91736455|NCT01440764|183366039|SUPERIORITY|||||||0.99||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. This p-value describes the a priori analysis of comparing the furosemide test result to the saline test result.|t-test, 2 sided|||||||0.99
91736456|NCT01440764|183366039|SUPERIORITY|||||||0.32||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. Thes p-value describes the a priori analysis of comparing the response to furosemide to the mean response to saline.|t-test, 2 sided|||||||0.32
91736457|NCT01440764|183366041|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0006
91736458|NCT01440764|183366041|SUPERIORITY||||||=|1e-05||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||=.00001
91497881|NCT02772081|182866074|SUPERIORITY||Adjusted mean difference|1.1||||0.284|TWO_SIDED|95.0|-1.0|3.3|||Mixed model for repeated measures|||120 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.3|-1.0|0.284
91736459|NCT01440764|183366041|SUPERIORITY|||||||2e-07||||||a priori threshold for significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0000002
91736460|NCT00557193|183366043|SUPERIORITY||Hazard Ratio (HR)|1.107||||0.672|ONE_SIDED|85.0||1.403||A priori significance level threshold of alpha=0.15|Log Rank||Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio|A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.||1.403||0.672
91736461|NCT00652834|183366056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.05|TWO_SIDED|95.0||||The p value is only for GSRS score comparison only.|t-test, 2 sided||The GSRS range is 1-7|"The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).~There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation."||||0.05
91736462|NCT00320606|183366057|OTHER||95% confidence interval using an exact b|0.6|||||TWO_SIDED|95.0|0.4|0.8|||||Proportion Success|The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method||0.8|0.4|
91736463|NCT00320606|183366058|OTHER||Binomial Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.1684|||||95% Confidence Interval Exact Binomial|The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.||0.1684|0.0|
91736464|NCT04358406|183366070|SUPERIORITY||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
91736465|NCT04358406|183366070|SUPERIORITY||||||>|0.1|||||||Chi-squared|||||||>0.1
91736466|NCT00256126|183366083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91736467|NCT00854360|183366116|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.255|TWO_SIDED|95.0|-0.8|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.80|0.255
91736468|NCT00854360|183366116|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.25||0.257|TWO_SIDED|95.0|-0.78|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.78|0.257
91736469|NCT00854360|183366116|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.013|TWO_SIDED|95.0|-1.13|-0.13||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.13|-1.13|0.013
91736470|NCT00854360|183366117|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.278|TWO_SIDED|95.0|-0.77|0.22||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.22|-0.77|0.278
91497882|NCT02772081|182866075|SUPERIORITY||Adjusted difference|-15.7||||0.22|TWO_SIDED|95.0|-39.6|8.2|||Cochran-Mantel-Haenszel|||Any intubation procedure in first 72 hours of life.||8.2|-39.6|0.220
91497883|NCT02772081|182866075|SUPERIORITY||Adjusted difference|4.9||||0.741|TWO_SIDED|95.0|-22.8|32.5|||Cochran-Mantel-Haenszel|||Any intubation procedure within 36 weeks PMA.||32.5|-22.8|0.741
91497884|NCT02772081|182866076|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.333|TWO_SIDED|95.0|-32.3|16.3|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV in first 28 days PNA.||16.3|-32.3|0.333
91530844|NCT03844321|182937759|SUPERIORITY|||||||0.307||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.307
91530845|NCT05822921|182937768|OTHER|Independent t-test was used.||||||0.871|||||||t-test, 2 sided|||||||.871
91704330|NCT03046056|183302730|SUPERIORITY||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|28.7|||TWO_SIDED|90.0|-68.0|28.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||28|-68|
91704331|NCT03046056|183302730|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|28.0|||TWO_SIDED|90.0|-52.0|42.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||42|-52|
91704332|NCT04591015|183302802|SUPERIORITY|||||||0.0626|||||||Fisher Exact|||||||0.0626
91704333|NCT04591015|183302803|SUPERIORITY|||||||0.0496|||||||t-test, 2 sided|||Only includes participants who completed a 90-day lab||||0.0496
91704334|NCT04591015|183302804|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||Only includes participants who completed a 180-day lab||||0.0651
91704335|NCT04591015|183302805|SUPERIORITY|||||||0.8739|||||||Fisher Exact|||||||0.8739
91704336|NCT04591015|183302806|SUPERIORITY|||||||0.4702|||||||t-test, 2 sided|||||||0.4702
91736471|NCT00854360|183366117|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.385|TWO_SIDED|95.0|-0.7|0.27||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.27|-0.70|0.385
91497885|NCT02772081|182866076|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.334|TWO_SIDED|95.0|-49.5|33.5|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV within 36 weeks PMA.||33.5|-49.5|0.334
91497886|NCT02772081|182866077|SUPERIORITY||Adjusted difference|-28.6||||0.596|TWO_SIDED|95.0|-120.9|63.6|||Wilcoxon (Mann-Whitney)|||Duration of invasive mechanical ventilation.||63.6|-120.9|0.596
91497887|NCT02772081|182866078|SUPERIORITY||CMH adjusted difference|-18.6||||0.219|TWO_SIDED|95.0|-47.0|9.8||The percentage of neonates needing invasive MV in the first 72 hours of life, was compared between the treatment groups using the Cochran-Mantel-Haenszel (CMH) test, adjusted for gestational age (GA) group.|Cochran-Mantel-Haenszel|||Invasive MV in the first 72 hours of life.||9.8|-47.0|0.219
91497888|NCT02772081|182866078|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV in first 28 days PNA||26.7|-33.5|0.826
91704337|NCT04591015|183302807|SUPERIORITY|||||||0.1258|||||||t-test, 2 sided|||||||0.1258
91704338|NCT04591015|183302808|SUPERIORITY|||||||0.8635|||||||t-test, 2 sided|||||||0.8635
91704339|NCT04591015|183302809|SUPERIORITY|||||||0.0471|||||||t-test, 2 sided|||||||0.0471
91704340|NCT04591015|183302810|SUPERIORITY|||||||0.0218|||||||t-test, 2 sided|||||||0.0218
91704341|NCT04591015|183302811|SUPERIORITY|||||||0.509|||||||t-test, 2 sided|||||||0.5090
91704342|NCT04591015|183302812|SUPERIORITY|||||||0.4034|||||||t-test, 2 sided|||||||0.4034
91704343|NCT04591015|183302813|SUPERIORITY|||||||0.0175|||||||t-test, 2 sided|||||||0.0175
91704344|NCT04591015|183302814|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||||||0.4435
91704345|NCT04591015|183302815|SUPERIORITY|||||||0.7417|||||||Fisher Exact|||||||0.7417
91704346|NCT04591015|183302816|SUPERIORITY|||||||0.5779|||||||t-test, 2 sided|||||||0.5779
91704347|NCT04591015|183302817|SUPERIORITY|||||||0.0493|||||||t-test, 2 sided|||||||0.0493
91704348|NCT04591015|183302818|SUPERIORITY|||||||0.0773|||||||t-test, 2 sided|||||||0.0773
91704349|NCT04591015|183302819|SUPERIORITY|||||||0.0921|||||||t-test, 2 sided|||||||0.0921
91704350|NCT04591015|183302820|SUPERIORITY|||||||0.2404|||||||t-test, 2 sided|||||||0.2404
91704351|NCT04591015|183302821|SUPERIORITY|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
91704352|NCT02509078|183302822|SUPERIORITY||Risk Difference (RD)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.9|||Wald test for the difference of two prop||Estimated value is a percentage|||5.9|-6.4|0.93
91704353|NCT00981058|183302855|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.842||||0.012|TWO_SIDED|95.0|0.736|0.962|||Log Rank|||||0.962|0.736|0.0120
91704354|NCT00981058|183302856|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0201|TWO_SIDED|95.0|0.743|0.975|||Log Rank|||||0.975|0.743|0.0201
91704355|NCT00981058|183302857|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.3997|TWO_SIDED|95.0|0.86|1.45|||Cochran-Mantel-Haenszel|||||1.45|0.86|0.3997
91704356|NCT00981058|183302858|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0061|TWO_SIDED|95.0|0.747|0.953|||Log Rank|||||0.953|0.747|0.0061
91704357|NCT02667587|183302864|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||||1.25|0.90|
91704358|NCT02667587|183302865|SUPERIORITY||Cox Proportional Hazard|1.12||||0.3402|TWO_SIDED|96.39|0.87|1.43|||Log Rank|||All Randomized No Baseline Corticosteroids Participants||1.43|0.87|0.3402
91704359|NCT02667587|183302865|SUPERIORITY||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||All Randomized Participants||1.33|0.91|
91704360|NCT02667587|183302869|SUPERIORITY||Cox Proportional Hazard|1.18|||||TWO_SIDED|95.0|0.99|1.4||||||||1.40|0.99|
91704361|NCT02667587|183302870|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.89|1.26|||Log Rank|||||1.26|0.89|
91497889|NCT02772081|182866078|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV within 36 weeks PMA.||26.7|-33.5|0.826
91497890|NCT03950167|182866091|OTHER||Mean Difference (Final Values)|0.85||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting CCK level difference: hyperemesis group-control group|||||0.05
91704362|NCT02696434|183302901|SUPERIORITY||Odds Ratio (OR)|0.68||||0.407|TWO_SIDED|95.0|0.28|1.68|||Regression, Logistic|||||1.68|0.28|0.407
91704363|NCT00355706|183302923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964||95.0|||||ANOVA|||||||0.964
91704364|NCT00355706|183302924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0|||||ANOVA|||||||0.892
91704365|NCT00355706|183302925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||95.0|||||ANOVA|||||||0.560
91704366|NCT00980174|183302950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8|||<|0.0001|TWO_SIDED|95.0|4.0|5.6|||ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||5.6|4.0|<0.0001
91704367|NCT00980174|183302951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||2.6|1.5|<0.0001
91704368|NCT00980174|183302952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|||<|0.0001|TWO_SIDED|95.0|1.3|3.0||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.0|1.3|<0.0001
91704369|NCT00980174|183302953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.4|3.2||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.2|1.4|<0.0001
91497891|NCT03950167|182866091|OTHER||Mean Difference (Net)|0.68||||0.05|TWO_SIDED||||||t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial CCK level difference: hyperemesis group-control group|Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.||||0.05
91497892|NCT03950167|182866092|OTHER||Mean Difference (Final Values)|0.91||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB wall thickness: Hyperemesis group-control group|||||0.05
91497893|NCT03950167|182866092|OTHER||Mean Difference (Final Values)|0.23||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group|||||0.05
91704370|NCT00980174|183302954|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.9||||0.0144|TWO_SIDED|95.0|0.2|1.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||1.6|0.2|0.0144
91704371|NCT00980174|183302955|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value is adjusted for multiple comparisons by Hochberg method|Van Elteren Rank Test|Adjusted by level of baseline bone mineral density T-score||||||<0.0001
91704372|NCT01546038|183302959|OTHER||Hazard Ratio (HR)|0.569||||0.002|TWO_SIDED|80.0|0.441|0.734||1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).|Log Rank||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||0.734|0.441|0.0020
91704373|NCT01546038|183302963|OTHER||Odds Ratio (OR)|4.2755||||0.0112|TWO_SIDED|80.0|1.3057|13.9994|||Cochran-Mantel-Haenszel||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||13.9994|1.3057|0.0112
91704374|NCT00424021|183303029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|46.93|||TWO_SIDED|95.0|-8.3|17.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||17.3|-8.3|
91704375|NCT00424021|183303030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|STANDARD_DEVIATION|73.16|||TWO_SIDED|95.0|-30.3|9.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||9.7|-30.3|
91704376|NCT00424021|183303031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_DEVIATION|83.08|||TWO_SIDED|95.0|-27.4|18.0||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||18.0|-27.4|
91704377|NCT00424021|183303032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|77.04|||TWO_SIDED|95.0|-34.9|7.1||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||7.1|-34.9|
91704378|NCT00424021|183303034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_DEVIATION|1.323|||TWO_SIDED|95.0|-0.15|0.57||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.57|-0.15|
91704379|NCT00424021|183303035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.659|||TWO_SIDED|95.0|0.01|0.92||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.92|0.01|
91704380|NCT00424021|183303036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.888|||TWO_SIDED|95.0|-0.02|1.02||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.02|-0.02|
91497894|NCT03950167|182866093|OTHER||Mean Difference (Final Values)|0.41||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB volume: hyperemesis group-control group|||||0.05
91497895|NCT03950167|182866093|OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group|||||0.05
91497896|NCT03950167|182866094|OTHER||Mean Difference (Final Values)|0.22||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB ejection fraction: hyperemesis group-control group|||||0.05
91497897|NCT03950167|182866094|OTHER||Mean Difference (Final Values)|0.63||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group|||||0.05
91497898|NCT00759954|182866095|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|97.19|||<|0.05||90.0|91.31|103.45|||ANOVA|||||103.45|91.31|<0.05
91704381|NCT00424021|183303037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.721|||TWO_SIDED|95.0|-0.01|0.93||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.93|-0.01|
91497899|NCT00759954|182866097|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|95.82|||<|0.05||90.0|92.93|98.8|||ANOVA|Analysis of Variance for the log-transformed AUC. The 90% confidence interval for the ratio of AUC(Test)/AUC(Ref) is provided.||||98.80|92.93|< 0.05
91497900|NCT00759954|182866098|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|98.1|||<|0.05||90.0|94.2|102.1|||ANOVA|||||102.1|94.2|< 0.05
91497901|NCT00982592|182866124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.874|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||||1.54|0.70|0.874
91497902|NCT00982592|182866126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.253|TWO_SIDED|95.0|0.83|2.05|||Log Rank|||||2.05|0.83|0.253
91497903|NCT01741701|182866129|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
91497904|NCT01741701|182866130|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of change between groups from baseline to 4 months||||0.51
91704382|NCT00424021|183303044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|19.41|||TWO_SIDED|95.0|-5.9|4.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.7|-5.9|
91704383|NCT00424021|183303045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|STANDARD_DEVIATION|25.79|||TWO_SIDED|95.0|-14.4|-0.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||-0.3|-14.4|
91736472|NCT00854360|183366117|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.09|-0.11||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated Measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.11|-1.09|0.016
91497905|NCT01741701|182866131|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||0.97
91497906|NCT01741701|182866132|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||.77
91497907|NCT01741701|182866133|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.90
91497908|NCT01741701|182866134|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.95
91497909|NCT04677374|182866135|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
91497910|NCT04677374|182866135|OTHER|||||||0.259|||||||Test of proportions|||||||0.259
91497911|NCT04677374|182866135|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
91497912|NCT04677374|182866136|OTHER||Hazard Ratio (HR)|2.23|||||TWO_SIDED|95.0|1.01|4.93||||||||4.93|1.01|
91497913|NCT04677374|182866136|OTHER||Hazard Ratio (HR)|1.66|||||TWO_SIDED|95.0|0.69|4.0||||||||4.00|0.69|
91497914|NCT04677374|182866136|OTHER||Hazard Ratio (HR)|2.31|||||TWO_SIDED|95.0|1.0|5.36||||||||5.36|1.00|
91497915|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-3.48|7.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.||7.70|-3.48|
91704384|NCT00424021|183303046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_DEVIATION|25.31|||TWO_SIDED|95.0|-12.0|1.8||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.8|-12.0|
91704385|NCT00424021|183303047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|23.69|||TWO_SIDED|95.0|-8.4|4.6||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.6|-8.4|
91704386|NCT01832818|183303053|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91497916|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|5.33|||||TWO_SIDED|95.0|-0.41|11.07||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.||11.07|-0.41|
91497917|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|2.49|||||TWO_SIDED|95.0|-3.35|8.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.||8.33|-3.35|
91497918|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-6.11|5.36||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.||5.36|-6.11|
91497919|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-1.57|10.29||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.||10.29|-1.57|
91704387|NCT01832818|183303054|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
91704388|NCT00236899|183303059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.345||95.0|0.87|1.5|||Regression, Cox|||||1.50|0.87|0.345
91704389|NCT00236899|183303060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.885
91704390|NCT00236899|183303061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.976|TWO_SIDED|95.0|0.71|1.42|||Regression, Cox|||||1.42|0.71|0.976
91704391|NCT00236899|183303062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.442||||0.0028|TWO_SIDED|95.0|0.259|0.754|||Regression, Logistic|||||0.754|0.259|0.0028
91704392|NCT00236899|183303063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.15|TWO_SIDED|95.0|0.93|1.62|||Regression, Cox|||||1.62|0.93|0.150
91704393|NCT00236899|183303064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.4567|TWO_SIDED|95.0|0.482|1.389|||Regression, Logistic|||||1.389|0.482|0.4567
91704394|NCT00236899|183303066|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.142
91704395|NCT00236899|183303066|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.470
91704396|NCT00236899|183303067|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.293
91704397|NCT00236899|183303067|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.476
91704398|NCT00568334|183303087|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.86|1.46|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.46|0.86|
91704399|NCT00568334|183303088|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.33|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.33|0.93|
91704400|NCT00625404|183303108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is \> 0.3||1.52|0.59|
91704401|NCT00625404|183303109|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.||||0.45
91704402|NCT00625404|183303111|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.59
91704403|NCT00625404|183303112|SUPERIORITY_OR_OTHER|||||||0.79|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.79
91704404|NCT00625404|183303113|SUPERIORITY_OR_OTHER|||||||0.62|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.62
91704405|NCT00625404|183303114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.89|||||||t-test, 2 sided|||t-test for difference on viral loads||||0.89
91704406|NCT00625404|183303115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.1||||0.82|||||||t-test, 2 sided|||t-test for difference in mean CD-4 counts||||0.82
91704407|NCT00625404|183303119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.73|||||||t-test, 2 sided|||t-test for difference in change in number of sexual partners over time||||0.73
91704408|NCT03313310|183303145|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.98||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.98
91704409|NCT03313310|183303145|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.05||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.05
91704410|NCT03313310|183303146|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.39||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.39
91704411|NCT03313310|183303146|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.76||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.76
91704412|NCT03313310|183303147|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.|||||<|0.001||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||<0.001
91704413|NCT03313310|183303147|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.02||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.02
91497920|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|4.6|||||TWO_SIDED|95.0|-1.45|10.65||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.||10.65|-1.45|
91497921|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|-4.25|||||TWO_SIDED|95.0|-10.44|1.93||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.||1.93|-10.44|
91497922|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|-0.45|||||TWO_SIDED|95.0|-7.22|6.32||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.||6.32|-7.22|
91497923|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|-1.46|||||TWO_SIDED|95.0|-8.25|5.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.||5.33|-8.25|
91497924|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-5.98|6.29||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.||6.29|-5.98|
91497925|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|1.52|15.08||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.||15.08|1.52|
91497926|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|3.82|||||TWO_SIDED|95.0|-2.85|10.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.||10.50|-2.85|
91497927|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-7.16|4.97||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.||4.97|-7.16|
91497928|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|6.78|||||TWO_SIDED|95.0|-0.11|13.66||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.||13.66|-0.11|
91736473|NCT00854360|183366118|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.082|TWO_SIDED|95.0|-0.95|0.06||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.06|-0.95|0.082
91736474|NCT00854360|183366118|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.114|TWO_SIDED|95.0|-0.9|0.1||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.10|-0.90|0.114
91736475|NCT00854360|183366118|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|95.0|-1.33|-0.33||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.33|-1.33|0.001
91736476|NCT00854360|183366119|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.747|TWO_SIDED|95.0|-0.52|0.37||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.37|-0.52|0.747
91736477|NCT00854360|183366119|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.605|TWO_SIDED|95.0|-0.53|0.31||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.31|-0.53|0.605
91736478|NCT00854360|183366119|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.083|TWO_SIDED|95.0|-0.84|0.05||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.05|-0.84|0.083
91760050|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|95.0|-1.18|-0.44||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.18|
91497929|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|3.29|||||TWO_SIDED|95.0|-3.58|10.15||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.||10.15|-3.58|
91497930|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-7.64|5.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.||5.40|-7.64|
91497931|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|3.59|||||TWO_SIDED|95.0|-3.71|10.89||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.||10.89|-3.71|
91497932|NCT00372112|182866157|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-4.96|9.18||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.||9.18|-4.96|
91497933|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-7.7|12.0||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.||12.0|-7.7|
91497934|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-7.2|13.1||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.||13.1|-7.2|
91497935|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-10.2|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.||10.1|-10.2|
91497936|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|95.0|-6.1|10.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.||10.4|-6.1|
91497937|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|-2.8|14.3||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.||14.3|-2.8|
91497938|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-6.9|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.||10.1|-6.9|
91530846|NCT05822921|182937769|OTHER|Independent t-test was used.||||||0.896|||||||t-test, 2 sided|||||||0.896
91497939|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|-4.9|||||TWO_SIDED|95.0|-16.1|6.2||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.||6.2|-16.1|
91497940|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-14.0|10.2||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.||10.2|-14.0|
91736479|NCT00854360|183366120|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.989|TWO_SIDED|95.0|-0.45|0.46||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.46|-0.45|0.989
91736480|NCT00854360|183366120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.808|TWO_SIDED|95.0|-0.39|0.5||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.50|-0.39|0.808
91704414|NCT03313310|183303148|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.51||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.51
91704415|NCT03313310|183303148|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.17||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.17
91704416|NCT03313310|183303149|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
91704417|NCT03313310|183303149|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
91704418|NCT03313310|183303150|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704419|NCT03313310|183303150|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.5||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.50
91704420|NCT03313310|183303151|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.63||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.63
91704421|NCT03313310|183303151|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704422|NCT03313310|183303152|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91497941|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-17.1|7.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.||7.5|-17.1|
91530847|NCT05822921|182937770|OTHER|Independent t-test was used.||||||0.351|||||||t-test, 2 sided|||||||0.351
91704423|NCT03313310|183303152|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.25||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.25
91704424|NCT03313310|183303153|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704425|NCT03313310|183303153|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704426|NCT03313310|183303154|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
91704427|NCT03313310|183303154|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
91704428|NCT03313310|183303156|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704429|NCT03313310|183303156|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704430|NCT03313310|183303157|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91704431|NCT03313310|183303157|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.75||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.75
91704432|NCT03313310|183303158|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.55||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.55
91704433|NCT03313310|183303158|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
91497942|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|-4.1|10.9||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.||10.9|-4.1|
91497943|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|2.6|19.0||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.||19.0|2.6|
91497944|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|3.1|||||TWO_SIDED|95.0|-5.2|11.4||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.||11.4|-5.2|
91497945|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-17.0|2.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.||2.7|-17.0|
91497946|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|5.4|||||TWO_SIDED|95.0|-6.0|16.8||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.||16.8|-6.0|
91497947|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-13.8|8.0||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.||8.0|-13.8|
91530848|NCT00064025|182937792|SUPERIORITY_OR_OTHER|||||||0.701|||||||Fisher Exact|||||||0.701
91736481|NCT00854360|183366120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.23||0.195|TWO_SIDED|95.0|-0.74|0.15||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.15|-0.74|0.195
91736482|NCT00854360|183366121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.31||0.903|TWO_SIDED|95.0|-0.64|0.57||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.57|-0.64|0.903
91736483|NCT00854360|183366121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.952|TWO_SIDED|95.0|-0.58|0.62||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.62|-0.58|0.952
91736484|NCT00854360|183366121|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-0.99|0.19||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.19|-0.99|0.187
91497948|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-7.8|8.3||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.||8.3|-7.8|
91497949|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|6.8|||||TWO_SIDED|95.0|-2.1|15.6||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.||15.6|-2.1|
91530849|NCT00064025|182937793|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
91736485|NCT03435380|183366122|SUPERIORITY||Risk Ratio (RR)|2.37||||0.019|TWO_SIDED|95.0|1.11|5.07|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||5.07|1.11|0.019
91736486|NCT03435380|183366122|SUPERIORITY||Risk Ratio (RR)|1.96||||0.092|TWO_SIDED|95.0|0.87|4.38|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||4.38|0.87|0.092
91736487|NCT03218917|183366138|SUPERIORITY||||||=|0.014||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by Pseudomonas aeruginosa (Pa) colonization status and maintenance antibiotic use at Baseline.||||||= 0.014
91497950|NCT00372112|182866159|SUPERIORITY||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-4.5|13.3||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.||13.3|-4.5|
91497951|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.1131|||||TWO_SIDED|95.0|-0.0031|0.2293|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2293|-0.0031|
91497952|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.159|||||TWO_SIDED|95.0|0.0408|0.2771|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2771|0.0408|
91497953|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.0764|||||TWO_SIDED|95.0|-0.0375|0.1903|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.||0.1903|-0.0375|
91497954|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.1741|||||TWO_SIDED|95.0|0.0178|0.3305|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3305|0.0178|
91530850|NCT00064025|182937794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
91530851|NCT02036515|182937813|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||Constrained longitudinal data analysis|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.50|-0.87|<0.001
91530852|NCT02036515|182937813|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.58|-0.95|<0.001
91530853|NCT02036515|182937814|SUPERIORITY_OR_OTHER||Difference in percentage|-5.7|||||TWO_SIDED|95.0|-16.5|5.2||||||||5.2|-16.5|
91530854|NCT02036515|182937814|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3|||||TWO_SIDED|95.0|-14.1|7.6||||||||7.6|-14.1|
91736488|NCT03218917|183366138|SUPERIORITY||||||=|0.022||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by colonization status and maintenance antibiotic use at Baseline.||||||= 0.022
91736489|NCT01908140|183366143|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin=-0,055 L|Mean Difference (Final Values)|0.093|||<|0.001|TWO_SIDED|95.0|0.063|0.123|||MMRM|If non-inferiority on the PP was achieved then switch to superiority was tested on the ITT.||This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0,055 L||0.123|0.063|<0.001
91736490|NCT01908140|183366144|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority limit -0.5 units|Mean Difference (Final Values)|-0.001|||>|0.05|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0,5||0.46|-0.46|>0.05
91736491|NCT00427193|183366145|OTHER||difference in mean change|0.02|STANDARD_DEVIATION|0.02||0.7|TWO_SIDED|95.0|-0.019|0.059||Type I error was controlled using a hierarchical gatekeeping strategy.|Mixed Models Analysis|||All analysis under intention-to-treat. All observations were included The primary analytic was a repeated measures analysis. The dependent variable was the change from baseline 12 \& 14mos., with treatment, time, and the treatment × time interaction as independent variables. Site, sex, BMI stratum, and the baseline value of the outcome were included as covariates. The predicted mean changes ± standard errors are the adjusted values from the contrasts of the multiple timepoints.||0.059|-0.019|0.70
91736492|NCT00427193|183366146|OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.0092|0.069|||Mixed Models Analysis|||||0.069|-0.0092|0.84
91704434|NCT03313310|183303159|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.45||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.45
91704435|NCT03313310|183303159|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.07||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.07
91704436|NCT02407054|183303248|SUPERIORITY||Hazard Ratio (HR)|0.5871|||||TWO_SIDED|95.0|0.3967|0.869||||||||0.8690|0.3967|
91704437|NCT02407054|183303249|SUPERIORITY||Hazard Ratio (HR)|0.6515|||||TWO_SIDED|95.0|0.4123|1.0294||||||||1.0294|0.4123|
91704438|NCT01447927|183303272|SUPERIORITY_OR_OTHER|||||||0.7981|||||||Wilcoxon Rank-Rum Test (1-sided)|||The null hypothesis was that the percent change in mean pS6K1 values (from pre to post) was the same or increased for the metformin arm as compared to placebo. Assuming equal standard deviations (i.e. 50%) across the metformin and placebo groups, 30 participants per arm yielded 84% power to detect at least a 35% decrease in the metformin arm as compared to placebo, using a 1-sided t-test with a significant level of 0.05.||||0.7981
91704439|NCT04114656|183303298|OTHER||Posterior Ratio to placebo|0.993|||||TWO_SIDED|95.0|0.968|1.02|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.020|0.968|
91704440|NCT04114656|183303299|OTHER||Posterior ratio to placebo|1.0|||||TWO_SIDED|95.0|0.89|1.12|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.12|0.89|
91704441|NCT04114656|183303300|OTHER||Posterior ratio to placebo|0.98|||||TWO_SIDED|95.0|0.91|1.05|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.05|0.91|
91704442|NCT00703326|183303301|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.077|TWO_SIDED|95.0|0.75|1.01|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.01|0.75|0.077
91736493|NCT00427193|183366147|OTHER||Mean Difference (Net)|-82.0|STANDARD_ERROR_OF_MEAN|11.12|<|0.001|TWO_SIDED|95.0|-103.8|-60.2|||Mixed Models Analysis|||||-60.2|-103.8|<0.001
91704443|NCT00703326|183303302|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.487|TWO_SIDED|95.0|0.81|1.1||The gate-keeping strategy used to control overall type 1 error 0.05 (2-sided) or 0.025 (1-sided) to analyze progression-free survival (PFS) and OS. At final PFS analysis only if primary PFS test was significant would analysis of OS be inferential.|Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.10|0.81|0.487
91704444|NCT00703326|183303303|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.033|TWO_SIDED|95.0|0.73|0.99|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||0.99|0.73|0.033
91704445|NCT00703326|183303304|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.027|TWO_SIDED|95.0|1.03|1.71|||Stratified Cochran-Mantel-Haenszel(SCMH)|SCMH used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|Stratified odds ratio was calculated considering the IWRS stratification factors.|||1.71|1.03|0.027
91704446|NCT00703326|183303305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.15|TWO_SIDED|95.0|0.67|1.06|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.06|0.67|0.150
91704447|NCT00703326|183303306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||P-value is for end of therapy. Analysis of covariance (ANCOVA) adjusted for baseline score was used to compare the 2 treatment arms.|ANCOVA|||||||0.539
91704448|NCT03052920|183303313|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 11.29||Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.||||<0.001
91704449|NCT03052920|183303314|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 16.947||Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.||||<0.001
91704450|NCT03052920|183303315|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05|t-test, 2 sided|t(35) = 2.14||Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.||||<0.05
91704451|NCT03052920|183303316|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 4.02||Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.||||<0.001
91704452|NCT03052920|183303317|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.58||Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.||||<0.05
91736494|NCT00427193|183366148|OTHER||Mean Difference (Final Values)|-64.0|STANDARD_DEVIATION|13.5|<|0.0001|TWO_SIDED|95.0|-90.5|-37.5|||Mixed Models Analysis|||||-37.5|-90.5|<0.0001
91736495|NCT00427193|183366149|OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|95.0|-0.16|0.23|||Mixed Models Analysis|||||0.23|-0.16|0.82
91736496|NCT00427193|183366150|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-6.5|-5.3|||Mixed Models Analysis|||Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) and Fat Free Mass (FFM) were determined for the whole body.||-5.3|-6.5|<0.001
91736497|NCT00427193|183366151|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.4|-5.3|||Mixed Models Analysis|||Comparison of change in FM in 2 groups over at 24 mos, controlling for site, sex, BMI group, and baseline FM. A repeated measures Mixed Model was employed for the analysis. For any outcome, Type I error was controlled using a hierarchical gatekeeping strategy testing, first, the GroupXTime interaction, and, if non-significant, the main effects of these two factors. Bonferroni corrections were employed for non-significant effects. All tests were at p\<0.05||-5.3|-6.4|<0.0001
91736498|NCT02581891|183366155|NON_INFERIORITY|The non-inferiority margin is set to 5 letters.|LS mean difference|-2.0199|STANDARD_ERROR_OF_MEAN|1.3833||0.0162|TWO_SIDED|95.0|-4.747|0.7073|||ANCOVA|||||0.7073|-4.7470|0.0162
91736499|NCT01076010|183366171|OTHER||25% Quartile (months)|8.0|||||TWO_SIDED|95.0|4.4|12.9||||||||12.9|4.4|
91736500|NCT01076010|183366171|OTHER||50% Quartile (months)|15.2|||||TWO_SIDED|95.0|11.1||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||11.1|
91736501|NCT01076010|183366171|OTHER||25% Quartile (months)|12.9|||||TWO_SIDED|95.0|5.6||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||5.6|
91497955|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.1713|||||TWO_SIDED|95.0|0.006|0.3365|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3365|0.0060|
91736502|NCT01076010|183366172|OTHER||25% Quartile (months)|3.6|||||TWO_SIDED|95.0|1.9|5.2||||||||5.2|1.9|
91736503|NCT01076010|183366172|OTHER||50% Quartile (months)|11.0|||||TWO_SIDED|95.0|7.3|12.7||||||||12.7|7.3|
91736504|NCT01076010|183366172|OTHER||75% Quartile (months)|20.9|||||TWO_SIDED|95.0|16.5||For the subjects in each treatment arm, PFS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||16.5|
91736505|NCT01076010|183366172|OTHER||25% Quartile (months)|7.2|||||TWO_SIDED|95.0|3.5|9.2||||||||9.2|3.5|
91736506|NCT01076010|183366173|OTHER||25% Quartile (months)|8.2|||||TWO_SIDED|95.0|6.0|12.1||||||||12.1|6.0|
91704453|NCT03052920|183303318|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 3.16||Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.||||<0.01
91704454|NCT03052920|183303319|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 10.42||Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.||||<0.001
91704455|NCT03052920|183303320|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.15||Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.||||<0.001
91704456|NCT03052920|183303321|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 4.34||Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.||||<0.001
91704457|NCT03052920|183303322|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.71||Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.||||<0.001
91704458|NCT03052920|183303323|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.90||Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.||||<0.001
91704459|NCT03052920|183303324|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 2.31||Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.||||<0.05
91736507|NCT01076010|183366173|OTHER||50% Quartile (months)|21.6|||||TWO_SIDED|95.0|17.0|27.6||||||||27.6|17.0|
91736508|NCT01076010|183366173|OTHER||75% Quartile (months)|30.7|||||TWO_SIDED|95.0|28.8||For the subjects in each treatment arm, OS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||28.8|
91760051|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|95.0|-1.48|-0.74||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.74|-1.48|
91497956|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.1377|||||TWO_SIDED|95.0|-0.0233|0.2987|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.||0.2987|-0.0233|
91497957|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.0266|0.3046|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3046|-0.0266|
91497958|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.1906|||||TWO_SIDED|95.0|0.0177|0.3635|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3635|0.0177|
91497959|NCT00372112|182866174|SUPERIORITY||Mean Difference (Net)|0.0956|||||TWO_SIDED|95.0|-0.0686|0.2599|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.||0.2599|-0.0686|
91497960|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.009|||||TWO_SIDED|95.0|-0.59|0.608|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.608|-0.590|
91497961|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.237|||||TWO_SIDED|95.0|-0.354|0.829|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.829|-0.354|
91497962|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.093|||||TWO_SIDED|95.0|-0.469|0.654|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.||0.654|-0.469|
91497963|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.199|||||TWO_SIDED|95.0|-0.591|0.988|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.||0.988|-0.591|
91497964|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.633|||||TWO_SIDED|95.0|-0.152|1.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.||1.418|-0.152|
91497965|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.065|||||TWO_SIDED|95.0|-0.667|0.797|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.||0.797|-0.667|
91736509|NCT01959932|183366203|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|8.38|||<|0.001|TWO_SIDED|95.0|6.89|10.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||10.20|6.89|<0.001
91497966|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.097|||||TWO_SIDED|95.0|-0.476|0.67|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.||0.670|-0.476|
91497967|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.408|||||TWO_SIDED|95.0|-0.208|1.024|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.||1.024|-0.208|
91497968|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.471|0.631|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.||0.631|-0.471|
91530855|NCT02036515|182937815|SUPERIORITY_OR_OTHER||Difference in percentage|0.6|||||TWO_SIDED|95.0|-4.4|5.6||||||||5.6|-4.4|
91497969|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.245|||||TWO_SIDED|95.0|-0.66|1.149|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.149|-0.660|
91497970|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.796|||||TWO_SIDED|95.0|-0.174|1.766|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.766|-0.174|
91497971|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.144|||||TWO_SIDED|95.0|-0.742|1.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.||1.030|-0.742|
91497972|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.056|||||TWO_SIDED|95.0|-0.556|0.669|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.669|-0.556|
91497973|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.138|||||TWO_SIDED|95.0|-0.767|0.491|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.491|-0.767|
91530856|NCT02036515|182937815|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.9|4.9||||||||4.9|-4.9|
91530857|NCT02036515|182937816|SUPERIORITY_OR_OTHER||Differenc in least squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-32.76|-17.54|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-17.54|-32.76|<0.001
91736510|NCT01959932|183366204|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|41.63|||<|0.001|TWO_SIDED|95.0|37.75|45.91||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||45.91|37.75|<0.001
91736511|NCT01959932|183366205|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|5.99|||<|0.001|TWO_SIDED|95.0|5.21|6.87||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||6.87|5.21|<0.001
91736512|NCT01959932|183366206|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.45|||<|0.001|TWO_SIDED|95.0|22.0|24.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||24.99|22.00|<0.001
91736513|NCT00758563|183366209|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
91736514|NCT00060944|183366210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.734||||0.0302|TWO_SIDED|95.0|0.554|0.974|||Log Rank|||||0.974|0.554|0.0302
91736515|NCT00060944|183366213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.0418|TWO_SIDED|95.0|0.574|0.992|||Log Rank|||||0.992|0.574|0.0418
91497974|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.187|||||TWO_SIDED|95.0|-0.765|0.391|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.||0.391|-0.765|
91736516|NCT00060944|183366214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.192|TWO_SIDED|95.0|0.653|1.09|||Log Rank|||||1.090|0.653|0.1920
91736517|NCT01138514|183366217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|98.77||||0.05|TWO_SIDED|90.0|95.2|102.5|||Fieller's method|||||102.5|95.2|0.05
91736518|NCT01138514|183366218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|100.27||||0.05|TWO_SIDED|90.0|95.6|105.2|||Fieller's method|||||105.2|95.6|0.05
91736519|NCT01138514|183366219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Clinical success was defined as a score of clear (0) or almost clear (1) on Investigators Global Assessment (IGA) at Visit 4/Week 10"|equivalence difference|1.6||||0.05|TWO_SIDED|90.0|-4.2|7.4|||Wald's method Yates' continuity correct|||||7.4|-4.2|0.05
91736520|NCT03961308|183366227|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0734|||||TWO_SIDED|90.0|0.9963|1.1565||||||||1.1565|0.9963|
91736521|NCT03961308|183366228|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0824|||||TWO_SIDED|90.0|1.0169|1.1521||||||||1.1521|1.0169|
91736522|NCT03961308|183366229|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0465|||||TWO_SIDED|90.0|0.9935|1.1023||||||||1.1023|0.9935|
91736523|NCT02297412|183366243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|||||||Wilcoxon (Mann-Whitney)|||||||0.0186
91736524|NCT02297412|183366244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1146|||||||Wilcoxon (Mann-Whitney)|||||||0.1146
91736525|NCT02297412|183366245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0243|||||||Wilcoxon (Mann-Whitney)|||||||0.0243
91736526|NCT04549454|183366248|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.598||0.985|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.985
91736527|NCT04549454|183366249|SUPERIORITY||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.618||0.694|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.694
91736528|NCT04549454|183366250|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
91736529|NCT04549454|183366251|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
91736530|NCT04549454|183366252|SUPERIORITY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.414||0.523|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.523
91736531|NCT04549454|183366253|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.427||0.981|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.981
91736532|NCT04549454|183366254|SUPERIORITY||Median Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
91736533|NCT04549454|183366255|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
91736534|NCT01355627|183366275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.23||0.485|||||||Regression, Logistic|Treatment and pooled centre as covariates.|\< 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.|||||0.485
91736535|NCT01230411|183366277|SUPERIORITY||Odds Ratio (OR)|3.12||||0.078|TWO_SIDED|95.0|0.88|11.0|||Regression, Logistic|||||11.0|0.88|0.078
91736536|NCT01405196|183366288|SUPERIORITY||Odds Ratio (OR)|2.23||||0.076|TWO_SIDED|90.0|0.89|5.62||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.62|0.89|0.076
91736537|NCT01405196|183366288|SUPERIORITY||Odds Ratio (OR)|0.96||||0.528|TWO_SIDED|90.0|0.38|2.41||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.41|0.38|0.528
91736538|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|2.77|||||TWO_SIDED|90.0|0.62|12.4||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||12.40|0.62|
91736539|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|90.0|0.31|7.71||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.71|0.31|
91736540|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|90.0|0.4|2.67||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.67|0.40|
91736541|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.29|2.05||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.05|0.29|
91736542|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|90.0|0.35|2.24||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.24|0.35|
91736543|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|0.44|||||TWO_SIDED|90.0|0.16|1.16||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.16|0.16|
91736544|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|90.0|0.64|4.09||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.09|0.64|
91736545|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|90.0|0.27|1.77||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.77|0.27|
91736546|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|1.95|||||TWO_SIDED|90.0|0.78|4.84||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.84|0.78|
91736547|NCT01405196|183366289|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.38|2.32||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.32|0.38|
91736548|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|90.0|0.28|3.88||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.88|0.28|
91530858|NCT02036515|182937816|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.28|||<|0.001|TWO_SIDED|95.0|-38.9|-23.66|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-23.66|-38.90|<0.001
91704460|NCT03052920|183303325|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.27||Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.||||<0.001
91736549|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.19|3.01||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.01|0.19|
91736550|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|90.0|0.28|1.85||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.85|0.28|
91736551|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|90.0|0.32|2.02||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.02|0.32|
91736552|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.3|1.83||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.83|0.30|
91736553|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|0.45|||||TWO_SIDED|90.0|0.18|1.13||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.13|0.18|
91736554|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|90.0|0.58|3.6||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.60|0.58|
91736555|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|0.74|||||TWO_SIDED|90.0|0.3|1.84||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.84|0.30|
91736556|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|1.78|||||TWO_SIDED|90.0|0.72|4.37||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.37|0.72|
91736557|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|90.0|0.5|2.92||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.92|0.50|
91736558|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|90.0|0.89|5.55||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.55|0.89|
91736559|NCT01405196|183366290|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.4|2.46||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.46|0.40|
91736560|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|90.0|0.53|3.35||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.35|0.53|
91736561|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|90.0|0.41|2.65||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.65|0.41|
91736562|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.33|1.96||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.96|0.33|
91736563|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|90.0|0.39|2.23||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.23|0.39|
91736564|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|90.0|0.42|2.45||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.45|0.42|
91736565|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|1.31|||||TWO_SIDED|90.0|0.55|3.1||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.10|0.55|
91736566|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|90.0|0.95|5.88||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.88|0.95|
91736567|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|90.0|0.74|4.46||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.46|0.74|
91704461|NCT03052920|183303326|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.65||Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.||||<0.001
91704462|NCT03052920|183303327|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.34||Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.||||<0.05
91497975|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.094|||||TWO_SIDED|95.0|-0.619|0.806|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.||0.806|-0.619|
91497976|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.358|||||TWO_SIDED|95.0|-0.39|1.105|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.||1.105|-0.390|
91497977|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.178|||||TWO_SIDED|95.0|-0.522|0.877|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.||0.877|-0.522|
91704463|NCT03539484|183303382|OTHER|A Bayesian approach is used to estimate the maximum tolerated dose (MTD).|Posterior probability at dose 1.8 mg|10.6|||||TWO_SIDED|95.0|2.1|26.5||There is no p-value derived; logistic regression is used to estimate the probability of DLT.|Regression, Logistic|||||26.5|2.10|
91704464|NCT02173379|183303416|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.||||||0.0244|ONE_SIDED|97.5|||||Farrington-Manning|||"The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE \< ∆TLF."||||0.0244
91704465|NCT02173379|183303417|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.||||||0.0006|||||||Farrington-Manning|||||||0.0006
91704466|NCT04997265|183303598|OTHER|Given the small sample size, simple descriptive were used. Between-group differences were performed using a Fisher exact test.|||||<|0.05|||||||Fisher Exact|||||||<0.05
91704467|NCT02290925|183303623|OTHER|general linear model (GLM) with repeated measures|Mean Difference (Net)|0.25|||||TWO_SIDED||||||||Box's M tests was used. Mauchly's test was used to verify that the error covariance matrix of the orthonormalized-transformed dependent variables is proportional to an identity matrix.||"We used intention to treat analysis. Since the missing data were more than 5%, we examined the dataset to determine whether it shows missing completely at random (MCAR) not missing at random (NMAR) or data missing at random (MAR). A sensitivity analysis was done to determine whether multiple imputations are required. It included complete case analysis, best-worst case and worst best case scenario with group mean±1SD."|||
91704468|NCT01973335|183303627|SUPERIORITY||Mean Difference (Final Values)|30.0||||0.515|TWO_SIDED|95.0|-63.0|123.0||Not adjusted for multiple comparisons|t-test, 2 sided|||2x2 factorial design: both acetazolamide groups together are compared with both high-dose loop diuretic groups together||123|-63|0.515
91704469|NCT01973335|183303628|SUPERIORITY||Risk Difference (RD)|-0.2||||0.27|TWO_SIDED|||||Not adjusted for multiple comparisons|Fisher Exact|||2x2 factorial design: analysis according to spironolactone use||||0.270
91704470|NCT01636947|183303659|SUPERIORITY_OR_OTHER|||||||0.191|||||||Pearson's chi-square test|||||||0.191
91704471|NCT01636947|183303660|SUPERIORITY_OR_OTHER|||||||0.458|||||||Pearson's chi-square test|||Overall Stage p-value||||0.458
91497978|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.294|||||TWO_SIDED|95.0|-0.586|-0.001|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.001|-0.586|
91704472|NCT00388297|183303671|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-3|0.71
91704473|NCT00388297|183303671|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|-1.0||||0.3|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-4|0.30
91704474|NCT00388297|183303672|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91704475|NCT00388297|183303672|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91704476|NCT00388297|183303673|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||Analysis for \< 34 weeks||||0.81
91704477|NCT00388297|183303673|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||Analysis for \<34 weeks||||0.47
91704478|NCT00388297|183303673|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Analysis for \<37 weeks||||0.44
91704479|NCT00388297|183303673|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Analysis for \< 37 weeks||||0.11
91704480|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.31|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (24 months)||3|0|0.31
91704481|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.3|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-II Language (24 months)||3|0|0.30
91704482|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (12 months)||0|0|0.89
91704483|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.54|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (12 months)||3|0|0.54
91704484|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.92|TWO_SIDED|95.0|-3.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|-3|0.92
91704485|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.70
91704486|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.2|TWO_SIDED|95.0|-3.0|0.0|||Chi-squared|||Bayley-III Motor (24 months)||0|-3|0.20
91704487|NCT00388297|183303673|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||Bayley-II Language (24 months)||2|-3|0.71
91704488|NCT00388297|183303674|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.89
91704489|NCT00388297|183303674|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.48|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.48
91704490|NCT00388297|183303675|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.9|TWO_SIDED|95.0|-2.0|3.0|||Chi-squared|||||3|-2|0.90
91704491|NCT00388297|183303675|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.64|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.64
91704492|NCT00388297|183303676|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.6|TWO_SIDED|95.0|-5.0|7.0|||Chi-squared|||Analysis for recall of digits forward||7|-5|0.60
91704493|NCT00388297|183303676|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.22|TWO_SIDED|95.0|-8.0|0.0|||Chi-squared|||Analysis for recall of digits forward||0|-8|0.22
91497979|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.371|||||TWO_SIDED|95.0|-0.657|-0.085|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.085|-0.657|
91497980|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.153|||||TWO_SIDED|95.0|-0.44|0.133|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.||0.133|-0.440|
91497981|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-0.679|0.247|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.||0.247|-0.679|
91497982|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.536|||||TWO_SIDED|95.0|-0.998|-0.074|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.||-0.074|-0.998|
91497983|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.018|||||TWO_SIDED|95.0|-0.452|0.416|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.||0.416|-0.452|
91497984|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.486|||||TWO_SIDED|95.0|-0.878|-0.095|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.095|-0.878|
91704494|NCT00388297|183303676|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.52|TWO_SIDED|95.0|-6.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-6|0.52
91497985|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.562|||||TWO_SIDED|95.0|-0.99|-0.135|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.135|-0.990|
91497986|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.575|0.196|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.||0.196|-0.575|
91497987|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.075|||||TWO_SIDED|95.0|-0.235|0.385|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.385|-0.235|
91497988|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.275|||||TWO_SIDED|95.0|-0.623|0.073|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.073|-0.623|
91497989|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.103|||||TWO_SIDED|95.0|-0.213|0.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.||0.418|-0.213|
91497990|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.299|||||TWO_SIDED|95.0|-0.64|0.042|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.042|-0.640|
91497991|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.271|||||TWO_SIDED|95.0|-0.621|0.079|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.079|-0.621|
91497992|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.095|||||TWO_SIDED|95.0|-0.432|0.243|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.||0.243|-0.432|
91497993|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.173|||||TWO_SIDED|95.0|-0.158|0.505|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.505|-0.158|
91497994|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.196|||||TWO_SIDED|95.0|-0.535|0.143|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.143|-0.535|
91497995|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.198|0.475|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.||0.475|-0.198|
91497996|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-1.18|0.9|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.||0.90|-1.18|
91497997|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.72|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.||1.30|-0.72|
91497998|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-1.15|0.8|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.||0.80|-1.15|
91704495|NCT00388297|183303676|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.91|TWO_SIDED|95.0|-4.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-4|0.91
91704496|NCT00388297|183303677|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.63|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley II Cognitive (12 months)||0|0|0.63
91704497|NCT00388297|183303677|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.83|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley II Motor (12 mo)||3|0|0.83
91497999|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.64|1.44|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.||1.44|-0.64|
91498000|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|-0.32|1.7|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.||1.70|-0.32|
91498001|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.74|1.2|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.||1.20|-0.74|
91498002|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-1.11|1.01|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.||1.01|-1.11|
91498003|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-0.57|1.62|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.||1.62|-0.57|
91498004|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.89|1.15|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.||1.15|-0.89|
91498005|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|-0.98|1.5|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.||1.50|-0.98|
91498006|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|-0.42|2.14|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.||2.14|-0.42|
91498007|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.9|1.54|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.||1.54|-0.90|
91498008|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-1.2|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.||1.30|-1.20|
91498009|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-0.53|2.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.||2.03|-0.53|
91498010|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.23|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.||1.23|-1.23|
91498011|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.22|||||TWO_SIDED|95.0|-0.78|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.||1.23|-0.78|
91498012|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|-0.21|1.89|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.||1.89|-0.21|
91498013|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.49|||||TWO_SIDED|95.0|-0.5|1.48|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.||1.48|-0.50|
91498014|NCT00372112|182866179|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.47|0.09|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.||0.09|-0.47|
91498015|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.49|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.||0.04|-0.49|
91498016|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.46|0.07|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.||0.07|-0.46|
91704498|NCT00388297|183303677|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.48|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|0|0.48
91704499|NCT00388297|183303677|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.59|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.59
91704500|NCT00388297|183303678|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.99|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.99
91704501|NCT00388297|183303678|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.96|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 60 months||2|-2|0.96
91704502|NCT00388297|183303678|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.65|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.65
91704503|NCT00388297|183303678|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.44|TWO_SIDED|95.0|-3.0|1.0|||Chi-squared|||CBCL at 60 months||1|-3|0.44
91704504|NCT00388297|183303679|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.37|TWO_SIDED|95.0|-1.0|2.0|||Chi-squared|||||2|-1|0.37
91704505|NCT00388297|183303679|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.98|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||||2|-2|0.98
91704506|NCT00388297|183303680|SUPERIORITY_OR_OTHER|||||||0.12|||||||Chi-squared|||||||0.12
91704507|NCT00388297|183303680|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
91704508|NCT00388297|183303681|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||||||0.69
91704509|NCT00388297|183303681|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
91498017|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.47|0.27|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.||0.27|-0.47|
91498018|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.73|-0.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.||-0.03|-0.73|
91498019|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.||0.34|-0.37|
91704510|NCT00388297|183303682|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
91704511|NCT00388297|183303682|SUPERIORITY_OR_OTHER|||||||0.64|||||||Chi-squared|||||||0.64
91704512|NCT00388297|183303683|SUPERIORITY_OR_OTHER|||||||0.66|||||||Chi-squared|||||||0.66
91704513|NCT00388297|183303683|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
91704514|NCT00388297|183303684|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
91704515|NCT00388297|183303684|SUPERIORITY_OR_OTHER|||||||0.55|||||||Chi-squared|||||||0.55
91736568|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|90.0|1.1|7.12||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.12|1.10|
91704516|NCT00388297|183303685|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
91736569|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|90.0|0.66|4.21||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.21|0.66|
91736570|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|2.95|||||TWO_SIDED|90.0|1.18|7.41||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.41|1.18|
91736571|NCT01405196|183366291|SUPERIORITY||Odds Ratio (OR)|2.03|||||TWO_SIDED|90.0|0.82|5.06||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.06|0.82|
91736572|NCT01405196|183366292|SUPERIORITY||Odds Ratio (OR)|1.59||||0.205|TWO_SIDED|90.0|0.63|4.02||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.02|0.63|0.205
91736573|NCT01405196|183366292|SUPERIORITY||Odds Ratio (OR)|0.84||||0.625|TWO_SIDED|90.0|0.34|2.08||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.08|0.34|0.625
91736574|NCT01405196|183366292|SUPERIORITY||Odds Ratio (OR)|2.81||||0.198|TWO_SIDED|90.0|0.38|20.65||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||20.65|0.38|0.198
91736575|NCT01405196|183366292|SUPERIORITY||Odds Ratio (OR)|2.88||||0.192|TWO_SIDED|90.0|0.39|21.3||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||21.30|0.39|0.192
91736576|NCT01405196|183366304|SUPERIORITY||LS mean difference|-5.41|||||TWO_SIDED|90.0|-12.3|1.49||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||1.49|-12.30|
91736577|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-1.39|||||TWO_SIDED|90.0|-8.21|5.42||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||5.42|-8.21|
91736578|NCT01405196|183366304|SUPERIORITY||LS Mean difference|1.3|||||TWO_SIDED|90.0|-5.71|8.32||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.32|-5.71|
91736579|NCT01405196|183366304|SUPERIORITY||LS Mean difference|4.67|||||TWO_SIDED|90.0|-2.22|11.57||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||11.57|-2.22|
91736580|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-3.98|||||TWO_SIDED|90.0|-11.04|3.07||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||3.07|-11.04|
91736581|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-2.89|||||TWO_SIDED|90.0|-9.87|4.1||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.10|-9.87|
91736582|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-6.21|||||TWO_SIDED|90.0|-13.37|0.94||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||0.94|-13.37|
91736583|NCT01405196|183366304|SUPERIORITY||LS Mean difference|1.98|||||TWO_SIDED|90.0|-5.17|9.13||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.13|-5.17|
91736584|NCT01405196|183366304|SUPERIORITY||LS Mean difference|2.07|||||TWO_SIDED|90.0|-4.7|8.84||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.84|-4.70|
91498020|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.97|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.97|
91498021|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.55|||||TWO_SIDED|95.0|-0.98|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.98|
91498022|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.76|0.08|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.||0.08|-0.76|
91498023|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.26|0.33|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.||0.33|-0.26|
91736585|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-2.81|||||TWO_SIDED|90.0|-9.62|4.0||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.00|-9.62|
91704517|NCT00388297|183303685|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
91704518|NCT00388297|183303686|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.50
91704519|NCT00388297|183303686|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
91704520|NCT00388297|183303687|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar at 1 min \< 4||||0.76
91704521|NCT00388297|183303687|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar \> 4 at 1 minute||||0.76
91704522|NCT00388297|183303687|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.69
91704523|NCT00388297|183303687|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.45
91704524|NCT00388297|183303688|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
91704525|NCT00388297|183303688|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||||||0.97
91704526|NCT00388297|183303689|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
91704527|NCT00388297|183303689|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||||||0.68
91704528|NCT00388297|183303690|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91704529|NCT00388297|183303690|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91704530|NCT00388297|183303691|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
91704531|NCT00388297|183303691|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||||||0.75
91704532|NCT00388297|183303692|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91704533|NCT00388297|183303693|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
91704534|NCT00388297|183303693|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
91704535|NCT00388297|183303694|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
91704536|NCT00388297|183303694|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
91704537|NCT00388297|183303695|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||||||0.99
91704538|NCT00388297|183303695|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|||||||0.85
91704539|NCT00388297|183303696|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91704540|NCT00388297|183303696|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91704541|NCT00316914|183303698|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||A priori threshold for the p-value is 0.05 and there was no adjustment for multiple comparisons.|Chi-squared|||Comparison in Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event between Arms||||0.038
91704542|NCT00316914|183303699|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||Log Rank|||Comparison of time to Onset of Grade 2+ Chronic Neurotoxicity between Arms||||0.0503
91704543|NCT00316914|183303700|SUPERIORITY_OR_OTHER|||||||0.4048||95.0|||||Log Rank|||Comparison of Time to Onset of Grade 3+ Chronic Neurotoxicity between Arms||||0.4048
91704544|NCT00316914|183303701|SUPERIORITY_OR_OTHER|||||||0.6556||95.0|||||Log Rank|||Comparison of Average Duration of Chronic Neuropathic Toxicity between Arms||||0.6556
91704545|NCT00316914|183303702|SUPERIORITY_OR_OTHER|||||||0.3238||95.0|||||Chi-squared|||Comparison of Percentage of patients discontinuing therapy for chronic neurotoxicity between Arms||||0.3238
91704546|NCT00316914|183303705|SUPERIORITY_OR_OTHER|||||||0.7498||95.0|||||Chi-squared|||Comparison of Percentage of Patients With Acute Neuropathic Adverse Event between Arms||||0.7498
91704547|NCT00316914|183303708|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Kruskal-Wallis|||Comparison of Fatigue NOW between two arms||||0.2340
91704548|NCT00316914|183303708|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Kruskal-Wallis|||Comparison of Fatigue USUAL between two arms||||0.2010
91704549|NCT00316914|183303708|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Comparison of Fatigue WORST between two arms||||0.9364
91704550|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Fatigue WORST||||0.9364
91704551|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.6275||95.0|||||Kruskal-Wallis|||Walking||||0.6275
91704552|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.6988||95.0|||||Kruskal-Wallis|||Buttoning Shirt or Tying Laces||||0.6988
91704553|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.5124||95.0|||||Kruskal-Wallis|||Diarrhea||||0.5124
91704554|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.3103||95.0|||||Kruskal-Wallis|||Constipation||||0.3103
91704555|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.8601||95.0|||||Kruskal-Wallis|||Abdominal Cramping||||0.8601
91704556|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.2439||95.0|||||Kruskal-Wallis|||Bowel Problems with Normal Activity||||0.2439
91704557|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.9283||95.0|||||Kruskal-Wallis|||Shortness of Breath (Week 2 - Baseline)||||0.9283
91704558|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Kruskal-Wallis|||Swallowing (Week 2 - Baseline)||||0.4715
91704559|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.5105||95.0|||||Kruskal-Wallis|||Numbness in Fingers, Toes (Week 2 - Baseline)||||0.5105
91704560|NCT00316914|183303709|SUPERIORITY_OR_OTHER|||||||0.2181||95.0|||||Kruskal-Wallis|||Tingling in Fingers, Toes (Week 2 - Baseline)||||0.2181
91498024|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.||-0.10|-0.70|
91498025|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.||0.34|-0.26|
91498026|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.42|0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.||0.12|-0.42|
91498027|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.51|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.||0.04|-0.51|
91498028|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.34|0.21|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.||0.21|-0.34|
91530859|NCT02036515|182937817|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.03|||<|0.001|TWO_SIDED|95.0|-2.65|-1.4|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.40|-2.65|<0.001
91498029|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.35|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.||0.35|-0.25|
91736586|NCT01405196|183366304|SUPERIORITY||LS Mean difference|3.97|||||TWO_SIDED|90.0|-2.95|10.9||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||10.90|-2.95|
91498030|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.66|-0.05|||Regression, Linear|||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.||-0.05|-0.66|
91498031|NCT00372112|182866179|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.||0.34|-0.26|
91498032|NCT04649060|182866192|SUPERIORITY||Hazard Ratio (HR)|0.184|||=|0.0032|TWO_SIDED|95.0|0.052|0.65|||Log Rank|||||0.650|0.052|=0.0032
91498033|NCT04649060|182866193|SUPERIORITY|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
91530860|NCT02036515|182937817|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.72|||<|0.001|TWO_SIDED|95.0|-2.35|-1.09|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.09|-2.35|<0.001
91736587|NCT01405196|183366304|SUPERIORITY||LS Mean difference|2.56|||||TWO_SIDED|90.0|-4.29|9.4||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.40|-4.29|
91736588|NCT01405196|183366304|SUPERIORITY||LS Mean difference|3.14|||||TWO_SIDED|90.0|-3.67|9.94||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.94|-3.67|
91498034|NCT04649060|182866194|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.525|TWO_SIDED|95.0|0.026|6.693|||Log Rank|||||6.693|0.026|0.525
91498035|NCT04649060|182866196|SUPERIORITY|||||||0.0997|||||||Cochran-Mantel-Haenszel|||||||0.0997
91498036|NCT04649060|182866197|SUPERIORITY||Hazard Ratio (HR)|0.111||||0.016|TWO_SIDED|95.0|0.013|0.96|||Log Rank|||||0.960|0.013|0.016
91498037|NCT04649060|182866199|SUPERIORITY||Hazard Ratio (HR)|0.231||||0.0187|TWO_SIDED|95.0|0.063|0.846|||Log Rank|||||0.846|0.063|0.0187
91498038|NCT04649060|182866200|SUPERIORITY||Hazard Ratio (HR)|0.224||||0.0384|TWO_SIDED|95.0|0.047|1.056|||Log Rank|||||1.056|0.047|0.0384
91498039|NCT04649060|182866201|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.3721|TWO_SIDED|95.0|0.086|2.569|||Log Rank|||||2.569|0.086|0.3721
91498040|NCT00143403|182866240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.67|1.2|||||HR: Irinotecan+5-FU/FA / 5-FU/FA|||1.20|0.67|
91498041|NCT00143403|182866240|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Log Rank|||||||0.468
91498042|NCT01860651|182866251|OTHER||mean difference over time|-0.002||||0.22|TWO_SIDED|95.0|-0.005|0.001|||Mixed Effect Model|||"Statistical analysis of Medical adherence in study Medication adm. at home were analysed using a Mixed Effect Model (MEM). The MEM model included a random patient effect and a fixed effect interaction between group and time, to evaluate difference between the groups over time."||0.001|-0.005|0.22
91530861|NCT02036515|182937818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.74|5.72|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||5.72|1.74|<0.001
91530862|NCT02036515|182937818|SUPERIORITY_OR_OTHER||Difference in least squares means|4.43|||<|0.001|TWO_SIDED|95.0|2.44|8.02|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||8.02|2.44|<0.001
91736589|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-4.94|||||TWO_SIDED|90.0|-11.91|2.03||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||2.03|-11.91|
91736590|NCT01405196|183366304|SUPERIORITY||LS Mean difference|-2.64|||||TWO_SIDED|90.0|-9.61|4.32||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.32|-9.61|
91736591|NCT01405196|183366304|SUPERIORITY||LS Mean difference|2.66|||||TWO_SIDED|90.0|-4.48|9.8||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.80|-4.48|
91736592|NCT01405196|183366305|SUPERIORITY||LS mean difference|3.63||||||90.0|-2.56|9.83||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||9.83|-2.56|
91530863|NCT02036515|182937819|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.93||||0.019|TWO_SIDED|95.0|-5.36|-0.49|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.49|-5.36|0.019
91704561|NCT02284568|183303729|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.1293||0.903|TWO_SIDED|95.0|-0.239|0.2705||significance at 0.05.|Repeated Measures ANCOVA|||The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||0.2705|-0.2390|0.903
91704562|NCT02284568|183303731|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.426|TWO_SIDED|95.0|0.48|1.37||significance at 0.05. p-value was from a log-rank test, and estimate and confidence limits were from a Cox model with treatment group as fixed effect, due to the violation of the proportionality assumption.|Log Rank||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.37|0.48|0.426
91704563|NCT02284568|183303732|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.867|TWO_SIDED|95.0|0.68|1.59||significance at 0.05.|Regression, Cox||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.59|0.68|0.867
91704564|NCT02284568|183303733|SUPERIORITY||Mean Difference (Final Values)|-0.325|STANDARD_ERROR_OF_MEAN|0.2679||0.248|TWO_SIDED|95.0|-0.85|0.2||significance at 0.05. The p-value for ranked change from baseline values was from a repeated measures analysis of covariance with trt group, week, treatment group by week interaction, rank of T25FW score at baseline, and country as fixed effects.|Repeated Measures ANCOVA||Laquinimod 0.6 mg vs. placebo treatment effect|placebo n=121 Laquinimod 0.6 mg n=108 The estimate of parameter, standard error, and 95% confidence intervals for change from baseline was from a Mann-Whitney-Wilcoxon Test using Hodges-Lehmann estimates.||0.2000|-0.8500|0.248
91704565|NCT02284568|183303734|SUPERIORITY||Risk Ratio (RR)|0.4|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED|95.0|0.26|0.69||significance at 0.05|negative binomial regression model||Laquinimod 0.6 mg vs. placebo risk ratio|This analysis was performed using baseline adjusted negative binomial regression model (SAS® PROC GENMOD) in which 1 contrast for comparing laquinimod 0.6 mg to placebo was constructed. In addition to the treatment group, the natural logarithm of T2 lesion volume at baseline, age at baseline and country/geographical region (CGR) were used as covariates.||0.69|0.26|0.001
91704566|NCT00460265|183303736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.873||||0.1403||95.0|0.729|1.046|||Log Rank|Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))|Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.046|0.729|0.1403
91704567|NCT00460265|183303737|SUPERIORITY_OR_OTHER||Difference in percentages|10.98||||||95.0|3.13|18.68||||||||18.68|3.13|
91704568|NCT00460265|183303737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||||95.0|1.15|2.44||||||||2.44|1.15|
91704569|NCT00460265|183303741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||||95.0|0.659|0.922|||||Cox proportional hazards model stratified by IVRS randomization factors|||0.922|0.659|
91736593|NCT01405196|183366305|SUPERIORITY||LS mean difference|-2.02||||||90.0|-8.21|4.18||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||4.18|-8.21|
91704570|NCT01642485|183303757|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The effect of insulin, C-peptide and glucose on QTcF was investigated using linear mixed effect concentration-response models with the double difference of QTcF (difference to time matched placebo of the change from average baseline) as dependent variable and up to two of the variables change from time matched placebo in insulin, C-peptide and glucose as covariates.||||0.05
91704571|NCT01642485|183303758|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The relevant confirmatory null hypotheses could all be rejected on the 5% level (one sided), i.e. a difference in QTcF between continental breakfast and placebo; between FDA breakfast and placebo could be ascertained.||||0.05
91736594|NCT01405196|183366305|SUPERIORITY||LS mean difference|2.62|||||TWO_SIDED|90.0|-3.57|8.82||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.82|-3.57|
91704572|NCT01642485|183303758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||||TWO_SIDED|90.0|-10.4|-5.5||||||||-5.5|-10.4|
91704573|NCT01642485|183303758|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||||TWO_SIDED|90.0|-9.3|-4.3||||||||-4.3|-9.3|
91704574|NCT00956631|183303777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.0001|TWO_SIDED|95.0|2.29|4.13|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.||4.13|2.29|<0.0001
91704575|NCT00956631|183303778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.58|||<|0.0001|TWO_SIDED|95.0|12.33|22.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.||22.83|12.33|<0.0001
91704576|NCT00904839|183303810|SUPERIORITY_OR_OTHER||Difference|-8.1|||||TWO_SIDED|95.0|-27.8|11.5|||Kaplan-Meier||Difference in Kaplan-Meier Progression-free Survival Rates at 9 Months using Peto´s variance estimate.|||11.5|-27.8|
91704577|NCT00904839|183303815|SUPERIORITY_OR_OTHER||Difference|-5.0|||||TWO_SIDED|95.0|-15.3|5.2|||Kaplan-Meier||confidence interval includes 0, meaning that the null hypothesis (no difference between the 2 groups) cannot be rejected (i.e. pvalue \> 0.05). The pvalue was not computed. Difference in Kaplan-Meier Resection Rates using Peto´s variance estimate.|||5.2|-15.3|
91704578|NCT00824382|183303859|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.091|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.051|0.131|||ANCOVA|||Olodaterol 2mcg - Placebo||0.131|0.051|<0.0001
91704579|NCT00824382|183303859|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.091|0.172|||ANCOVA|||Olodaterol 5mcg - Placebo||0.172|0.091|<0.0001
91498043|NCT03235154|182866310|OTHER|There was no comparator arm in this small single arm study||||||||||||No confidence intervals around point estimates provided given very small number of participants||||This was a single arm intervention study with a very small number of participants. Therefore, only descriptive statistics are provided.|No confidence intervals around point estimates provided given very small number of participants|||
91498044|NCT00536198|182866311|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Group comparison||||0.21
91498045|NCT00536198|182866311|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91498046|NCT00536198|182866311|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.06
91498047|NCT00536198|182866311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.88|STANDARD_ERROR_OF_MEAN|0.95||0.049|TWO_SIDED|95.0|0.01|3.75|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||3.75|0.01|0.049
91498048|NCT00536198|182866312|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||ANOVA|||Group comparison||||0.54
91498049|NCT00536198|182866312|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91498050|NCT00536198|182866312|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.02
91498051|NCT00536198|182866312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.14|STANDARD_ERROR_OF_MEAN|1.62||0.0015|TWO_SIDED|95.0|1.97|8.31|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||8.31|1.97|0.0015
91498052|NCT00536198|182866313|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group comparison||||0.46
91498053|NCT00536198|182866313|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.0001
91498054|NCT00536198|182866313|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.69
91498055|NCT00536198|182866313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.84|TWO_SIDED|95.0|0.83|1.26|||Mixed Models Analysis|||Estimated mean difference from Cycle 1 to end point between active vs. placebo||1.26|0.83|0.84
91498056|NCT00536198|182866314|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
91498057|NCT00536198|182866314|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Change over time in both groups||||<0.001
91498058|NCT00536198|182866314|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||0.28
91498059|NCT00536198|182866314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.056|TWO_SIDED|95.0|0.3|1.19|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.19|0.30|0.056
91498060|NCT00536198|182866316|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||Group comparison||||0.30
91498061|NCT00536198|182866316|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.01
91498062|NCT00536198|182866316|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
91498063|NCT00536198|182866316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12||||0.06|TWO_SIDED|95.0|0.92|1.35|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.35|0.92|0.06
91498064|NCT00536198|182866317|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||ANOVA|||Group comparison||||0.80
91498065|NCT00536198|182866317|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91498066|NCT00536198|182866317|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.43
91498067|NCT00536198|182866317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11||||0.61|TWO_SIDED|95.0|0.85|1.45|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||1.45|0.85|0.61
91498068|NCT00536198|182866318|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||ANOVA|||Group comparison||||0.83
91498069|NCT00536198|182866318|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91530864|NCT02036515|182937819|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.94||||0.002|TWO_SIDED|95.0|-6.39|-1.5|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.50|-6.39|0.002
91498070|NCT00536198|182866318|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.02
91498071|NCT00536198|182866318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.169|TWO_SIDED|95.0|0.96|1.25|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.25|0.96|0.169
91498072|NCT00536198|182866319|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||Group comparison||||0.37
91498073|NCT00536198|182866319|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91498074|NCT00536198|182866319|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
91498075|NCT00536198|182866319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.08||||0.13|TWO_SIDED|95.0|0.91|1.28|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.28|0.91|0.13
91498076|NCT00536198|182866320|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANOVA|||Group comparison||||0.31
91498077|NCT00536198|182866320|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91498078|NCT00536198|182866320|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.46
91498079|NCT00536198|182866320|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.94|TWO_SIDED|95.0|0.96|1.23|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.23|0.96|0.94
91498080|NCT00536198|182866321|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Group comparison||||<0.001
91498081|NCT00536198|182866321|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
91498082|NCT00536198|182866321|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||<0.01
91498083|NCT00536198|182866321|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.22||||0.027|TWO_SIDED|95.0|1.05|1.41|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.41|1.05|0.027
91498084|NCT00536198|182866322|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
91498085|NCT00536198|182866322|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||<0.001
91498086|NCT00536198|182866322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.056|TWO_SIDED|95.0|0.3|1.02|||Mixed Models Analysis|||Estimated mean difference between active and placebo groups at end-point only||1.02|0.30|0.056
91498087|NCT00965718|182866356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||||||Global health status scores at baseline and final observation point were compared via a 2-sided t-test.|t-test, 2 sided|||||||0.123
91498088|NCT01244425|182866372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood-ratio chi square test|||||||<0.001
91498089|NCT01244425|182866373|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood ratio chi-square test|||||||<0.001
91530865|NCT02036515|182937820|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76|||||TWO_SIDED|95.0|-0.98|-0.54||||||||-0.54|-0.98|
91498090|NCT01244425|182866374|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||likelihood ratio chi-square test|||||||0.028
91498091|NCT01244425|182866375|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||likelihood ratio chi-square test|||||||0.017
91498092|NCT01244425|182866376|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||likelihood ratio chi-square test|||||||0.293
91498093|NCT01244425|182866377|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||likelihood ratio chi-square test|||||||0.237
91498094|NCT01244425|182866378|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||likelihood ratio chi-square test|||||||0.808
91498095|NCT02771990|182866411|OTHER|Pilot study|z-score|3.11||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
91498096|NCT02771990|182866412|OTHER|Pilot study||||||0.67|||||||Regression, Linear|||||||0.67
91498097|NCT00720434|182866425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.||-0.53485|-4.19228|0.0131
91530866|NCT02036515|182937820|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.83|||||TWO_SIDED|95.0|-1.05|-0.61||||||||-0.61|-1.05|
91530867|NCT02036515|182937821|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.76|||||TWO_SIDED|95.0|-36.44|-21.09||||||||-21.09|-36.44|
91530868|NCT02036515|182937821|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.58|||||TWO_SIDED|95.0|-37.3|-21.85||||||||-21.85|-37.30|
91530869|NCT02036515|182937822|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.51|||||TWO_SIDED|95.0|-3.43|-1.59||||||||-1.59|-3.43|
91736595|NCT01405196|183366305|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-4.51|7.88||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.88|-4.51|
91736596|NCT01405196|183366305|SUPERIORITY||LS mean difference|4.59|||||TWO_SIDED|90.0|-1.61|10.79||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.79|-1.61|
91736597|NCT01405196|183366305|SUPERIORITY||LS mean difference|3.95||||||90.0|-2.24|10.15||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.15|-2.24|
91736598|NCT01405196|183366305|SUPERIORITY||LS mean difference|1.92||||||90.0|-4.17|8.01||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.01|-4.17|
91736599|NCT01405196|183366305|SUPERIORITY||LS mean difference|-4.2||||||90.0|-10.25|1.85||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||1.85|-10.25|
91736600|NCT01405196|183366305|SUPERIORITY||LS mean difference|1.5|||||TWO_SIDED|90.0|-4.56|7.55||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.55|-4.56|
91736601|NCT01405196|183366305|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|90.0|-5.96|6.15||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||6.15|-5.96|
91736602|NCT01405196|183366305|SUPERIORITY||LS mean difference|-0.34|||||TWO_SIDED|90.0|-6.39|5.71||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||5.71|-6.39|
91736603|NCT01405196|183366305|SUPERIORITY||LS mean difference|-2.34|||||TWO_SIDED|90.0|-8.39|3.71||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||3.71|-8.39|
91736604|NCT01405196|183366307|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
91736605|NCT01405196|183366307|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
91736606|NCT01405196|183366307|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
91736607|NCT01405196|183366307|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
91736608|NCT01405196|183366307|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
91736609|NCT01405196|183366307|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
91736610|NCT01405196|183366307|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
91736611|NCT01405196|183366307|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
91736612|NCT01405196|183366307|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
91736613|NCT01405196|183366307|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
91736614|NCT01405196|183366307|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
91736615|NCT01405196|183366307|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
91736616|NCT01405196|183366307|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
91736617|NCT01405196|183366307|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
91736618|NCT01405196|183366307|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
91736619|NCT01405196|183366307|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
91736620|NCT01405196|183366307|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
91736621|NCT01405196|183366307|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
91736622|NCT01405196|183366307|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
91736623|NCT01405196|183366307|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
91736624|NCT01405196|183366307|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
91498098|NCT00720434|182866425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
91498099|NCT00720434|182866425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
91498100|NCT00720434|182866425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
91736625|NCT01405196|183366307|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
91736626|NCT01405196|183366307|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
91736627|NCT01405196|183366307|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
91736628|NCT01405196|183366308|SUPERIORITY||LS mean difference|0.47||||||90.0|-6.33|7.27||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.27|-6.33|
91736629|NCT01405196|183366308|SUPERIORITY||LS mean difference|3.92||||||90.0|-2.88|10.72||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.72|-2.88|
91498101|NCT00720434|182866425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
91498102|NCT00720434|182866425|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
91736630|NCT01405196|183366308|SUPERIORITY||LS mean difference|3.55|||||TWO_SIDED|90.0|-3.25|10.36||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.36|-3.25|
91736631|NCT01405196|183366308|SUPERIORITY||LS mean difference|7.85|||||TWO_SIDED|90.0|1.05|14.66||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||14.66|1.05|
91736632|NCT01405196|183366308|SUPERIORITY||LS mean difference|7.12|||||TWO_SIDED|90.0|0.32|13.92||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||13.92|0.32|
91736633|NCT01405196|183366308|SUPERIORITY||LS mean difference|4.33|||||TWO_SIDED|90.0|-2.47|11.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||11.13|-2.47|
91736634|NCT01405196|183366308|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-5.4|8.05||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.05|-5.40|
91736635|NCT01405196|183366308|SUPERIORITY||LS mean difference|3.93|||||TWO_SIDED|90.0|-2.75|10.62||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.62|-2.75|
91736636|NCT01405196|183366308|SUPERIORITY||LS mean difference|-0.78|||||TWO_SIDED|90.0|-7.47|5.91||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.91|-7.47|
91736637|NCT01405196|183366308|SUPERIORITY||LS mean difference|3.67||||||90.0|-3.02|10.35||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.35|-3.02|
91736638|NCT01405196|183366308|SUPERIORITY||LS mean difference|2.99|||||TWO_SIDED|90.0|-3.7|9.68||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||9.68|-3.70|
91736639|NCT01405196|183366308|SUPERIORITY||LS mean difference|1.44|||||TWO_SIDED|90.0|-5.24|8.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.13|-5.24|
91736640|NCT01405196|183366309|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
91736641|NCT01405196|183366309|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
91736642|NCT01405196|183366309|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
91736643|NCT01405196|183366309|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
91736644|NCT01405196|183366309|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
91498103|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.6|||||TWO_SIDED|95.0|0.1565|0.8785||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.8785|0.1565|
91736645|NCT01405196|183366309|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
91736646|NCT01405196|183366309|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
91736647|NCT01405196|183366309|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
91498104|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.75|||||TWO_SIDED|95.0|0.233|0.969||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9690|0.2330|
91498105|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.625|||||TWO_SIDED|95.0|0.0871|0.9191||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9191|0.0871|
91498106|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025|||||TWO_SIDED|95.0|-0.4769|0.4336||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
91498107|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125||||||95.0|-0.4024|0.6049||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
91498108|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
91498109|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.3|||||TWO_SIDED|95.0|-0.1836|0.6931||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6931|-0.1836|
91736648|NCT01405196|183366309|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
91736649|NCT01405196|183366309|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
91736650|NCT01405196|183366309|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
91736651|NCT01405196|183366309|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
91736652|NCT01405196|183366309|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
91736653|NCT01405196|183366309|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
91736654|NCT01405196|183366309|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
91736655|NCT01405196|183366309|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
91736656|NCT01405196|183366309|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
91736657|NCT01405196|183366309|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
91736658|NCT01405196|183366309|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
91736659|NCT01405196|183366309|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
91736660|NCT01405196|183366309|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
91736661|NCT01405196|183366309|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
91736662|NCT01405196|183366309|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
91498110|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.375|||||TWO_SIDED|95.0|-0.1732|0.7797||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.7797|-0.1732|
91530870|NCT02036515|182937822|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88|||||TWO_SIDED|95.0|-2.81|-0.95||||||||-0.95|-2.81|
91736663|NCT01405196|183366309|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
91736664|NCT01405196|183366311|SUPERIORITY||LS mean difference|2.08|||||TWO_SIDED|90.0|-1.26|5.42||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the Least Square (LS) mean difference from that model.||5.42|-1.26|
91736665|NCT01405196|183366311|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.38|5.29||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.38|
91736666|NCT01405196|183366311|SUPERIORITY||LS mean difference|2.81|||||TWO_SIDED|90.0|-0.53|6.15||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.15|-0.53|
91736667|NCT01405196|183366311|SUPERIORITY||LS mean difference|3.88|||||TWO_SIDED|90.0|0.54|7.22||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.22|0.54|
91736668|NCT01405196|183366311|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.39|5.29||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.39|
91736669|NCT01405196|183366311|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.65|5.03||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.03|-1.65|
91736670|NCT01405196|183366311|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.61|4.99||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.99|-1.61|
91498111|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
91498112|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.175|||||TWO_SIDED|95.0|-0.2934|0.5917||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5917|-0.2934|
91498113|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
91498114|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.075|||||TWO_SIDED|95.0|-0.5144|0.388||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3880|-0.5144|
91498115|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.1|||||TWO_SIDED|95.0|-0.3728|0.5414||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5414|-0.3728|
91498116|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
91498117|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
91498118|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025||||||95.0|-0.4769|0.4336||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
91498119|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
91498120|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
91498121|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
91498122|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
91498123|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
91736671|NCT01405196|183366311|SUPERIORITY||LS mean difference|0.97|||||TWO_SIDED|90.0|-2.31|4.26||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-2.31|
91498124|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
91498125|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
91498126|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
91736672|NCT01405196|183366311|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-1.96|4.61||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.61|-1.96|
91736673|NCT01405196|183366311|SUPERIORITY||LS mean difference|3.6|||||TWO_SIDED|90.0|0.32|6.89||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.89|0.32|
91736674|NCT01405196|183366311|SUPERIORITY||LS mean difference|0.91|||||TWO_SIDED|90.0|-2.38|4.19||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.19|-2.38|
91736675|NCT01405196|183366311|SUPERIORITY||LS mean difference|0.6|||||TWO_SIDED|90.0|-2.68|3.88||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.88|-2.68|
91736676|NCT01542788|183366312|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by presence or absence of cirrhosis for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 180 subjects in the active group and 60 in the placebo group would provide 99% power to detect a difference between group SVR12 rates of 40% using a 2-sided continuity-corrected chi-square test at significance level of 0.05.||83.6|71.0|< 0.001
91736677|NCT01542788|183366314|SUPERIORITY_OR_OTHER||Proportion difference|82.7|||||TWO_SIDED|95.0|76.8|88.5|||||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||88.5|76.8|
91736678|NCT01542788|183366315|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by randomization stratification factor for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||83.6|71.0|< 0.001
91498127|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
91498128|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
91736679|NCT01400412|183366318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank sum test stratified by age (\<30 and \>=30 years)||The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48||||<0.001
91736680|NCT01649869|183366338|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome based on generalized estimating equations.||||||0.0859
91736681|NCT01649869|183366339|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
91736682|NCT01649869|183366340|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91736683|NCT01649869|183366341|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
91498129|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
91498130|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
91498131|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
91498132|NCT00720434|182866426|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
91736684|NCT01649869|183366342|SUPERIORITY|||||||0.0752|||||||Fisher Exact|||||||0.0752
91736685|NCT01649869|183366344|SUPERIORITY|||||||0.4823|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.4823
91736686|NCT01649869|183366345|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.0859
91736687|NCT01649869|183366346|OTHER|Association of binary outcome and continuous outcome||||||0.8212|||||||Generalized linear model|For binary outcome using generalized estimating equations||||||0.8212
91736688|NCT01649869|183366347|OTHER|Association of binary outcome and continuous outcome and continuous outcome||||||0.8356|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.8356
91736689|NCT01649869|183366348|OTHER|Association of binary outcome and continuous outcome||||||0.7961|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations||||||0.7961
91736690|NCT01649869|183366349|OTHER|Association of binary outcome and continuous outcome||||||0.8675|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.8675
91736691|NCT01649869|183366350|OTHER|Association of binary outcome and continuous outcome||||||0.9682|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.9682
91736692|NCT01649869|183366351|OTHER|Association of binary outcome and continuous outcome||||||0.6063|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.6063
91736693|NCT01649869|183366352|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
91736694|NCT01649869|183366353|SUPERIORITY|||||||0.6043|||||||Fisher Exact|||||||0.6043
91498133|NCT00720434|182866429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53485|-4.19228|0.0131
91498134|NCT00720434|182866429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
91530871|NCT02036515|182937823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||||TWO_SIDED|95.0|1.98|6.64||||||||6.64|1.98|
91530872|NCT02036515|182937823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||||TWO_SIDED|95.0|2.22|7.28||||||||7.28|2.22|
91736695|NCT01649869|183366354|SUPERIORITY|||||||0.6513|||||||Fisher Exact|||||||0.6513
91736696|NCT01649869|183366355|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91736697|NCT01649869|183366356|SUPERIORITY|||||||0.0659|||||||Fisher Exact|||||||0.0659
91736698|NCT01649869|183366357|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91736699|NCT01126190|183366364|NON_INFERIORITY|Non-inferiority was demonstrated if the upper endpoint of the CI for the difference in mean DSN was less than or equal to 0.62 days|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.13|0.37||||||For the primary non-inferiority endpoint of cycle 1 DSN, the 95% confidence interval (CI) for difference in DSN was calculated by stratified bootstrap resampling.||0.37|-0.13|
91736700|NCT01977898|183366368|SUPERIORITY|||||||0.877|||||||Fisher Exact|||A sample size of 65 patients in each group would be required to achieve 80% power to detect this difference between intrathecal morphine and saline administration . Sample size of 64 per group achieve 80% power to detect a difference between the group proportions of 0.25. The proportion in the treatment group is assumed to be 0.5 under the null hypothesis and 0.25 under the alternative hypothesis. The proportion in the control group is .05.The significance level of the test was targeted at .05.||||.877
91736701|NCT01977898|183366369|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
91736702|NCT01977898|183366370|SUPERIORITY|||||||0.463|||||||Chi-squared|||||||.463
91736703|NCT01977898|183366371|SUPERIORITY|||||||0.0463|||||||Chi-squared|||||||.0463
91736704|NCT01977898|183366372|SUPERIORITY|||||||0.525|||||||Chi-squared|||||||.525
91736705|NCT01977898|183366373|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
91498135|NCT00720434|182866429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
91736706|NCT01977898|183366374|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.610
91736707|NCT01977898|183366375|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
91736708|NCT01977898|183366376|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
91736709|NCT01977898|183366377|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||.31
91736710|NCT01049373|183366384|SUPERIORITY_OR_OTHER|||||||0.0426|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0426
91736711|NCT01049373|183366385|SUPERIORITY_OR_OTHER|||||||0.0757|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0757
91736712|NCT01049373|183366386|SUPERIORITY_OR_OTHER|||||||0.0465|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0465
91736713|NCT01049373|183366387|SUPERIORITY_OR_OTHER|||||||0.04443|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04443
91736714|NCT01198587|183366415|SUPERIORITY|||||||0.88|||||||Log Rank|||||||0.88
91498136|NCT00720434|182866429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
91736715|NCT01198587|183366415|SUPERIORITY|||||||0.19|||||||Log Rank|||||||0.19
91736716|NCT01365793|183366572|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.34||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to \<14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.||||0.34
91736717|NCT01365793|183366572|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.43||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to \<14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.||||0.43
91736718|NCT01734902|183366666|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|86.97|STANDARD_ERROR_OF_MEAN|35.6|||TWO_SIDED|90.0|74.046|102.151|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.151|74.046|
91736719|NCT01734902|183366667|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|89.05|STANDARD_ERROR_OF_MEAN|31.2|||TWO_SIDED|90.0|77.26|102.62|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.62|77.26|
91736720|NCT01734902|183366668|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R [%]|90.03|STANDARD_ERROR_OF_MEAN|29.3|||TWO_SIDED|90.0|78.78|102.88|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.88|78.78|
91736721|NCT02972996|183366728|OTHER|||||||0.56|||||||ANCOVA|||Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.||||0.56
91736722|NCT02972996|183366729|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
91736723|NCT04756531|183366765|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|81.21|||||TWO_SIDED|90.0|69.21|95.28||||||||95.28|69.21|
91736724|NCT04756531|183366766|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|76.06|||||TWO_SIDED|90.0|60.14|96.2||||||||96.20|60.14|
91736725|NCT04756531|183366767|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|56.38|||||TWO_SIDED|90.0|43.42|73.19||||||||73.19|43.42|
91760052|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.72|0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.72|
91498137|NCT00720434|182866429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
91498138|NCT00720434|182866429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
91498139|NCT02425046|182866438|SUPERIORITY|||||||0.67||||||Threshold for statistical significance \<0.05|t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||||||0.67
91498140|NCT02425046|182866439|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||null hypothesis - there will be no difference between the groups.||||0.735
91530873|NCT02036515|182937824|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99|||||TWO_SIDED|95.0|-7.82|-2.15||||||||-2.15|-7.82|
91498141|NCT02425046|182866440|SUPERIORITY|||||||0.599|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis that there would be no difference in change in FNPA scores between the two groups over 12 months.||||0.599
91498142|NCT02425046|182866441|SUPERIORITY|||||||0.583|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis: Change in MVPA from baseline to 12 months will not be different between target children in the two groups.||||0.583
91498143|NCT02425046|182866442|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||Null hypothesis is that there will be no difference between the two arms in change in sugar sweetened beverage intake over 12 months.||||0.312
91498144|NCT02425046|182866443|SUPERIORITY||difference in change between two arms|75.0||||0.1|TWO_SIDED|95.0|-15.0|165.0|||Linear quantile mixed model|Linear quantile mixed models (a non-parametric linear mixed model) was used because of non-normal distribution that could not be transformed.|Comparison of the intervention target adult change in reported physical activity compared to the control group.|Linear quantile mixed models (a non-parametric linear mixed model) was used because because of non-normal distribution that could not be remedied by transformation.||165|-15|0.10
91498145|NCT02425046|182866444|SUPERIORITY||difference in change between two arms|-2.54||||0.057|TWO_SIDED|95.0|-5.14|0.07|||Mixed Models Analysis||The intervention arm in comparison to the control arm.|||0.07|-5.14|0.057
91498146|NCT02425046|182866445|SUPERIORITY|||||||0.874|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.874
91530874|NCT02036515|182937824|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.92|||||TWO_SIDED|95.0|-7.76|-2.07||||||||-2.07|-7.76|
91530875|NCT02036515|182937825|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24|||||TWO_SIDED|95.0|-2.97|0.48||||||||0.48|-2.97|
91530876|NCT02036515|182937825|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38|||||TWO_SIDED|95.0|-3.11|0.36||||||||0.36|-3.11|
91530877|NCT02036515|182937826|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||||TWO_SIDED|95.0|-2.82|0.84||||||||0.84|-2.82|
91498147|NCT02425046|182866446|SUPERIORITY||% difference in change between arms|7.0||||0.31|TWO_SIDED|95.0|-7.0|23.0|||Mixed Models Analysis|Screen time was log transformed to normalized the distribution. Results have been back transformed from log 10 scale.|% change in screen time of the intervention arm compared to the control arm.|||23|-7|0.31
91498148|NCT02425046|182866447|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.516
91498149|NCT01409564|182866448|SUPERIORITY_OR_OTHER|||||||0.14|||||||Repeated ANOVA|Uncorrected, Repeated ANOVA||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.14
91498150|NCT01409564|182866448|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.08
91736726|NCT04756531|183366800|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|148.91|||||TWO_SIDED|90.0|126.92|174.72||||||||174.72|126.92|
91736727|NCT04756531|183366801|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|146.8|||||TWO_SIDED|90.0|118.8|181.41||||||||181.41|118.80|
91736728|NCT04756531|183366802|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|244.84|||||TWO_SIDED|90.0|188.58|317.87||||||||317.87|188.58|
91736729|NCT00253422|183366835|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.76|TWO_SIDED|95.0|0.86|1.24|||Log Rank|||||1.24|0.86|0.76
91736730|NCT00253422|183366835|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.83|1.2|||Log Rank|||||1.20|0.83|1.00
91498151|NCT01409564|182866448|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||<0.01
91498152|NCT01409564|182866448|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||0.08
91498153|NCT01409564|182866449|SUPERIORITY_OR_OTHER|||||||0.93|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)||||0.93
91498154|NCT01409564|182866450|SUPERIORITY_OR_OTHER|||||||0.15|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)||||0.15
91736731|NCT00253422|183366836|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
91736732|NCT00253422|183366836|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
91736733|NCT00253422|183366838|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
91736734|NCT00253422|183366838|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
91736735|NCT00253422|183366840|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR less than 1 favour Faslodex + Arimidex|||1.21|0.84|0.95
91498155|NCT01409564|182866451|SUPERIORITY_OR_OTHER|||||||0.82|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)||||0.82
91498156|NCT01409564|182866452|SUPERIORITY_OR_OTHER|||||||0.79|||||||Chi-squared|||Repeated ANOVA, tested for group\*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)||||0.79
91498157|NCT01409564|182866453|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||Distribution of Fazekas scale in two groups according to Chi-square test results.||||0.87
91498158|NCT02782780|182866454|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.01||||||Test of treatment effect: t(91.6)=3.21|Mixed Models Analysis|||||||<0.01
91530878|NCT02036515|182937826|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.85|||||TWO_SIDED|95.0|-2.69|0.99||||||||0.99|-2.69|
91530879|NCT02036515|182937827|SUPERIORITY_OR_OTHER||Difference in percent|-15.1|||||TWO_SIDED|95.0|-21.9|-9.4||||||||-9.4|-21.9|
91530880|NCT02036515|182937827|SUPERIORITY_OR_OTHER||Difference in percent|-14.4|||||TWO_SIDED|95.0|-21.3|-8.5||||||||-8.5|-21.3|
91736736|NCT00253422|183366840|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.66|TWO_SIDED|95.0|0.87|1.25|||Log Rank||HR less than 1 favours Faslodex + placebo|||1.25|0.87|0.66
91736737|NCT00253422|183366841|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.91|TWO_SIDED|95.0|0.82|1.19|||Log Rank||HR less than 1 favours Faslodex + Arimidex|||1.19|0.82|0.91
91736738|NCT00253422|183366841|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.31|TWO_SIDED|95.0|0.91|1.32|||Log Rank||HR less than 1 favours Faslodex + Placebo|||1.32|0.91|0.31
91736739|NCT04712669|183366855|SUPERIORITY||Mean Difference (Final Values)|57.27|STANDARD_ERROR_OF_MEAN|24.773||0.0208|TWO_SIDED|95.0|8.716|105.824||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||105.824|8.716|0.0208
91736740|NCT04712669|183366855|SUPERIORITY||Mean Difference (Final Values)|58.406|STANDARD_ERROR_OF_MEAN|24.558||0.0174|TWO_SIDED|95.0|10.272|106.54||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||106.54|10.272|0.0174
91498159|NCT02782780|182866454|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTI group: t(92.3)=4.10|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||||||<0.001
91498160|NCT02782780|182866455|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001||||||test of treatment effect: t(94.7)=6.10|Mixed Models Analysis|||||||<0.001
91530881|NCT02036515|182937828|SUPERIORITY_OR_OTHER||Difference in percentage|-29.0|||||TWO_SIDED|95.0|-38.3|-19.4||||||||-19.4|-38.3|
91736741|NCT04712669|183366856|SUPERIORITY|||||||0.573||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.573
91736742|NCT04712669|183366856|SUPERIORITY|||||||0.9911||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.9911
91736743|NCT04712669|183366857|SUPERIORITY||Median Difference (Final Values)|-33.61|STANDARD_ERROR_OF_MEAN|18.121||0.0636|TWO_SIDED|95.0|-69.13|1.91||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||1.91|-69.13|0.0636
91736744|NCT04712669|183366857|SUPERIORITY||Median Difference (Final Values)|-19.05|STANDARD_ERROR_OF_MEAN|13.469||0.1573|TWO_SIDED|95.0|-45.45|7.35||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||7.35|-45.45|0.1573
91736745|NCT04712669|183366858|SUPERIORITY||Mean Difference (Final Values)|1125.9|STANDARD_ERROR_OF_MEAN|351.28||0.0014|TWO_SIDED|95.0|437.39|1814.39|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1814.39|437.39|0.0014
91736746|NCT04712669|183366858|SUPERIORITY||Mean Difference (Final Values)|866.3|STANDARD_ERROR_OF_MEAN|306.56||0.0047|TWO_SIDED|95.0|265.41|1467.16|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1467.16|265.41|0.0047
91736747|NCT02286895|183366907|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-4.0|4.2||||||Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.2|-4.0|
91736748|NCT02286895|183366908|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-12.2|4.0||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.0|-12.2|
91736749|NCT02286895|183366909|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-7.5|2.7||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||2.7|-7.5|
91498161|NCT02782780|182866455|SUPERIORITY||||||<|0.001||||||baseline vs. 6-month follow-up in CBTI group: t(94)=6.67|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||To compare baseline data to 6-month follow-up data in the CBT-I group, planned contrasts following the mixed models were used.||||<0.001
91498162|NCT02782780|182866456|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(104)=3.40||||||<0.001
91498163|NCT02782780|182866456|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(91.6)=4.37|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
91498164|NCT02782780|182866457|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|test of treatment effect: t(99.9)=2.09||||||<0.05
91530882|NCT02036515|182937828|SUPERIORITY_OR_OTHER||Difference in percentage|-28.1|||||TWO_SIDED|95.0|-37.5|-18.4||||||||-18.4|-37.5|
91530883|NCT02036515|182937832|SUPERIORITY_OR_OTHER||Difference in least squares means|12.75|||||TWO_SIDED|95.0|6.83|18.68||||||||18.68|6.83|
91530884|NCT02036515|182937832|SUPERIORITY_OR_OTHER||Difference in least squares means|11.91|||||TWO_SIDED|95.0|5.94|17.88||||||||17.88|5.94|
91498165|NCT02782780|182866457|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(92.1)=2.56||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||<0.01
91498166|NCT02782780|182866458|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||=|0.991|||||||Mixed Models Analysis|Test of treatment effect: t(110)=-0.41||||||=0.991
91498167|NCT02782780|182866458|SUPERIORITY||||||=|0.41||||||Baseline vs. 6-month follow-up in CBTi group: t(91.8)=0.94|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||=0.41
91498168|NCT02782780|182866459|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|Test of treatment effect: t(83.7)=2.51||||||<0.05
91498169|NCT02782780|182866459|SUPERIORITY||||||=|0.49||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(90.9)=0.27||||||=0.49
91498170|NCT02782780|182866460|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.01|||||||Mixed Models Analysis|test of treatment effect: t(105)=4.55||||||<0.01
91498171|NCT02782780|182866460|SUPERIORITY||||||<|0.01||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(91.3)=3.23||||||<0.01
91530885|NCT02036515|182937833|SUPERIORITY_OR_OTHER||Difference in least squares means|12.78|||||TWO_SIDED|95.0|6.54|19.03||||||||19.03|6.54|
91530886|NCT02036515|182937833|SUPERIORITY_OR_OTHER||Difference in least squares means|12.86|||||TWO_SIDED|95.0|6.54|19.18||||||||19.18|6.54|
91530887|NCT02036515|182937835|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||||0.02|-0.04|
91498172|NCT02782780|182866461|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(91.6)=3.37||||||<0.001
91498173|NCT02782780|182866461|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: (92.1)=3.64|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
91498174|NCT02782780|182866462|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(99.2)=5.45||||||<0.001
91498175|NCT02782780|182866462|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(93.4)=6.06|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
91498176|NCT02782780|182866463|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(76.9)=-4.20||||||<0.001
91498177|NCT02782780|182866463|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(33.1)=6.52|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
91498178|NCT02782780|182866464|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.6)=4.33||||||<0.001
91498179|NCT02782780|182866464|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(34.4)=4.75||||||<0.001
91498180|NCT02782780|182866465|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.1)=3.91||||||<0.001
91498181|NCT02782780|182866465|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month in CBTi group: t(34.5)=4.39||||||<0.001
91498182|NCT03654651|182866487|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||Mixed Models Analysis|||||1.6|-2.7|
91498183|NCT03654651|182866487|OTHER|change from baseline|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|||||0.9|-2.7|
91530888|NCT02036515|182937835|SUPERIORITY_OR_OTHER||Difference in least squares means|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
91530889|NCT02036515|182937836|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
91530890|NCT02036515|182937836|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.02|||||TWO_SIDED|95.0|-0.07|0.02||||||||0.02|-0.07|
91530891|NCT00518713|182937837|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0120
91530892|NCT00518713|182937837|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0015
91498184|NCT03654651|182866487|OTHER|Change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4|||Mixed Models Analysis|||||1.4|-2.2|
91498185|NCT03654651|182866488|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-4.8|3.4|||Mixed Models Analysis|||||3.4|-4.8|
91498186|NCT03654651|182866488|OTHER|change from baseline|Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
91498187|NCT03654651|182866488|OTHER|change from baseline|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
91498188|NCT03654651|182866489|SUPERIORITY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.2|2.1|||Mixed Models Analysis|||||2.1|-1.2|
91498189|NCT03654651|182866489|OTHER|change from baseline|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-1.5|1.0|||Mixed Models Analysis|||||1.0|-1.5|
91498190|NCT03654651|182866489|OTHER|change from baseline|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||||0.5|-2.1|
91498191|NCT03654651|182866490|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-3.1|4.6|||Mixed Models Analysis|||peripheral systolic BP||4.6|-3.1|
91530893|NCT00518713|182937837|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
91530894|NCT00518713|182937838|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0027
91530895|NCT00518713|182937838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
91498192|NCT03654651|182866490|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||peripheral diastolic BP||2.9|-2.1|
91498193|NCT03654651|182866490|OTHER|change from baseline|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||peripheral systolic BP change from baseline||3.3|-2.5|
91498194|NCT03654651|182866490|OTHER|change from baseline|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-3.1|2.6|||Mixed Models Analysis|||peripheral systolic BP change from baseline||2.6|-3.1|
91498195|NCT03654651|182866490|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2.5|-1.5|
91498196|NCT03654651|182866490|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2|-2|
91498197|NCT03654651|182866491|SUPERIORITY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.4|4.4|||Mixed Models Analysis|||central systolic BP||4.4|-2.4|
91498198|NCT03654651|182866491|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-1.7|3.3|||Mixed Models Analysis|||central diastolic BP||3.3|-1.7|
91498199|NCT03654651|182866491|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||Mixed Models Analysis|||central systolic BP change from baseline||3.1|-1.9|
91498200|NCT03654651|182866491|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.9|2.1|||Mixed Models Analysis|||central systolic BP change from baseline||2.1|-2.9|
91498201|NCT03654651|182866491|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.6|||Mixed Models Analysis|||central diastolic BP change from baseline||2.6|-1.5|
91498202|NCT03654651|182866491|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.4|1.6|||Mixed Models Analysis|||central diastolic BP change from baseline||1.6|-2.4|
91498203|NCT03654651|182866492|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|0.5|||Mixed Models Analysis|||||0.5|-0.1|
91498204|NCT03654651|182866492|OTHER|change from baseline|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||||0.6|0.1|
91498205|NCT03654651|182866492|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|
91498206|NCT03654651|182866493|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.9|3.3|||Mixed Models Analysis|||||3.3|-5.9|
91498207|NCT03654651|182866493|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-3.7|2.9|||Mixed Models Analysis|||||2.9|-3.7|
91498208|NCT03654651|182866493|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.0|4.3|||Mixed Models Analysis|||||4.3|-4.0|
91498209|NCT03654651|182866494|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-1.4|9.8|||Mixed Models Analysis|||||9.8|-1.4|
91530896|NCT00518713|182937838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
91530897|NCT00518713|182937839|SUPERIORITY_OR_OTHER|||||||0.1041||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1041
91498210|NCT03654651|182866494|OTHER|change from baseline|Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-2.1|6.9|||Mixed Models Analysis|||||6.9|-2.1|
91498211|NCT03654651|182866494|OTHER|change from baseline|Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-6.8|2.2|||Mixed Models Analysis|||||2.2|-6.8|
91498212|NCT03654651|182866495|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.3|2.3|||Mixed Models Analysis|||||2.3|-2.3|
91498213|NCT03654651|182866495|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|
91498214|NCT03654651|182866495|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||||2.3|-1.6|
91498215|NCT03654651|182866496|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.8|8.2|||Mixed Models Analysis|||||8.2|-3.8|
91498216|NCT03654651|182866496|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-4.9|5.1|||Mixed Models Analysis|||||5.1|-4.9|
91498217|NCT03654651|182866496|OTHER|change from baseline|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-7.8|2.3|||Mixed Models Analysis|||||2.3|-7.8|
91530898|NCT00518713|182937839|SUPERIORITY_OR_OTHER|||||||0.2207||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2207
91498218|NCT03654651|182866497|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-18.3|2.8|||Mixed Models Analysis|||||2.8|-18.3|
91498219|NCT03654651|182866497|OTHER|change from baseline|Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-29.1|-4.8|||Mixed Models Analysis|||||-4.8|-29.1|
91498220|NCT03654651|182866497|OTHER|change from baseline|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-17.1|5.7|||Mixed Models Analysis|||||5.7|-17.1|
91498221|NCT03654651|182866498|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|
91498222|NCT03654651|182866498|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|1.5|||Mixed Models Analysis|||||1.5|-0.1|
91498223|NCT03654651|182866498|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||||0.5|-0.5|
91513586|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.0|-0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.6|-4.0|< 0.001
91530899|NCT00518713|182937839|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0025
91704580|NCT00824382|183303859|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.092|0.172|||ANCOVA|||Olodaterol 10mcg - Placebo||0.172|0.092|<0.0001
91498224|NCT04615923|182866508|SUPERIORITY||Disease Rate Ratio|0.99|STANDARD_DEVIATION|0.103|||TWO_SIDED|95.0|0.801|1.207||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. Pridopidine slowed progression) was (0.5475). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.207|0.801|
91498225|NCT04615923|182866510|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.334||0.78|TWO_SIDED|95.0|-0.75|0.57|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.57|-0.75|0.78
91736750|NCT02286895|183366910|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
91736751|NCT02286895|183366911|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1|geometric mean titer ratio|-0.7|||||TWO_SIDED|95.0|-5.2|3.8||||||||3.8|-5.2|
91736752|NCT02286895|183366912|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.7|1.3||||||||1.3|0.7|
91736753|NCT02286895|183366913|SUPERIORITY||Mean Difference (Net)|17.5|||||TWO_SIDED|95.0|9.7|25.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||25.3|9.7|
91736754|NCT02286895|183366914|SUPERIORITY||Mean Difference (Net)|15.8|||||TWO_SIDED|95.0|8.1|23.4||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.4|8.1|
91736755|NCT02286895|183366915|SUPERIORITY||Mean Difference (Net)|25.4|||||TWO_SIDED|95.0|14.6|36.2||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||36.2|14.6|
91736756|NCT02286895|183366916|SUPERIORITY||Mean Difference (Net)|31.1|||||TWO_SIDED|95.0|23.1|39.0||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||39.0|23.1|
91498226|NCT04615923|182866511|SUPERIORITY||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.217||0.6594|TWO_SIDED|95.0|-0.33|0.52|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.52|-0.33|0.6594
91498227|NCT04615923|182866512|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|1.745||0.7918|TWO_SIDED|95.0|-3.89|2.96|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||2.96|-3.89|0.7918
91498228|NCT04615923|182866513|SUPERIORITY||Median Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.426||0.9903|TWO_SIDED|95.0|-0.83|0.84|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.84|-0.83|0.9903
91498229|NCT04615923|182866514|SUPERIORITY|Analysis performed using interval-censored survival analysis. This type of model accommodates interval censoring between ALSFRS-R assessments|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.69|1.27|||Regression, Cox|Interval censored cox model adjusted for time since symptom onset, pre-baseline change in ALSFRS-R, baseline use of edaravone, riluzole, and neudexta||||1.27|0.69|
91498230|NCT04615923|182866515|SUPERIORITY||Mean Difference (Net)|-1.78|STANDARD_ERROR_OF_MEAN|3.285||0.5888|TWO_SIDED|95.0|-8.23|4.67|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||4.67|-8.23|0.5888
91498231|NCT04615923|182866516|SUPERIORITY|||||||0.969|||||||Log Rank|||||||0.9690
91736757|NCT02286895|183366917|SUPERIORITY||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|12.0|23.5||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.5|12.0|
91736758|NCT02286895|183366918|SUPERIORITY||Mean Difference (Net)|52.0|||||TWO_SIDED|95.0|37.7|66.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||66.3|37.7|
91736759|NCT02286895|183366919|SUPERIORITY||geometric mean titer ratio|1.7|||||TWO_SIDED|95.0|1.2|2.4||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||2.4|1.2|
91736760|NCT02286895|183366920|SUPERIORITY||geometric mean titer ratio|2.3|||||TWO_SIDED|95.0|1.7|3.1||||||Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.1|1.7|
91736761|NCT02286895|183366921|SUPERIORITY||geometric mean titer ratio|2.0|||||TWO_SIDED|95.0|1.2|3.3||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.3|1.2|
91498232|NCT03395886|182866517|OTHER|||||||0.831|||||||Chi-squared|||Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.||||0.831
91498233|NCT03395886|182866518|OTHER|||||||0.8|||||||Generalized estimating equations|||||||0.800
91498234|NCT00589914|182866519|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.62|2.38||No p-value to report.|ANCOVA|ANCOVA model with factors treatment, country and baseline score. Weighted approach used to account for interim analysis for sample size re-estimation.||Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.||2.38|-1.62|
91498235|NCT00589914|182866520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.07|0.17||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||0.17|-0.07|
91498236|NCT00589914|182866521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.22|1.69||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||1.69|-1.22|
91498237|NCT02618434|182866524|SUPERIORITY||Median Difference (Net)|-0.56||||0.9383|TWO_SIDED|95.0|-8.96|7.84|||Wilcoxon (Mann-Whitney)|||||7.84|-8.96|0.9383
91498238|NCT02618434|182866525|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0979|TWO_SIDED|95.0|-0.33|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.33|0.0979
91498239|NCT02618434|182866525|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.50|0.0502
91498240|NCT02618434|182866525|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.141||0.4769|TWO_SIDED|95.0|-0.38|0.18|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.18|-0.38|0.4769
91498241|NCT02618434|182866526|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.113||0.0881|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.41|0.0881
91704581|NCT00824382|183303860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.039|0.124|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.124|0.039|0.0002
91498242|NCT02618434|182866526|SUPERIORITY||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.135||0.0522|TWO_SIDED|95.0|-0.53|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.53|0.0522
91498243|NCT02618434|182866526|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.156||0.1766|TWO_SIDED|95.0|-0.52|0.1|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.10|-0.52|0.1766
91498244|NCT02618434|182866527|SUPERIORITY||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.613||0.3409|TWO_SIDED|95.0|-1.64|4.72|||ANCOVA|||This analysis pertains to the Physical Functioning Summary Score at Visit 6.||4.72|-1.64|0.3409
91498245|NCT02618434|182866527|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_ERROR_OF_MEAN|0.952||0.0215|TWO_SIDED|95.0|-4.08|-0.33|||ANCOVA|||This analysis pertains to the Psychosocial Health Summary Score at Visit 6.||-0.33|-4.08|0.0215
91704582|NCT00824382|183303860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.184|0.098|<0.0001
91704583|NCT00824382|183303860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.115|0.199|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.199|0.115|<0.0001
91736762|NCT02286895|183366922|SUPERIORITY||geometric mean titer ratio|4.6|||||TWO_SIDED|95.0|2.4|8.9||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||8.9|2.4|
91498246|NCT02618434|182866528|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|2.0||0.5977|TWO_SIDED|95.0|-5.0|2.89|||ANCOVA|||This analysis pertains to the Total Score at Visit 6.||2.89|-5.00|0.5977
91498247|NCT02618434|182866528|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.807||0.8049|TWO_SIDED|95.0|-1.39|1.79|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.79|-1.39|0.8049
91498248|NCT02618434|182866528|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.801||0.8911|TWO_SIDED|95.0|-1.47|1.69|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.69|-1.47|0.8911
91498249|NCT02618434|182866528|SUPERIORITY||Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.849||0.1426|TWO_SIDED|95.0|-2.93|0.42|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||0.42|-2.93|0.1426
91498250|NCT02618434|182866529|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.134||0.6171|TWO_SIDED|95.0|-0.33|0.2|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.20|-0.33|0.6171
91498251|NCT02618434|182866529|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.143||0.0617|TWO_SIDED|95.0|-0.55|0.01|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.01|-0.55|0.0617
91498252|NCT02618434|182866529|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.4419|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.21|-0.47|0.4419
91498253|NCT02618434|182866530|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0416|TWO_SIDED|95.0|-0.32|-0.01|||ANCOVA|||This analysis pertains to the Inattention subscale at Visit 6.||-0.01|-0.32|0.0416
91498254|NCT02618434|182866530|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.089||0.0921|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||This analysis pertains to Hyperactivity/Impulsivity subscale at Visit 6||0.02|-0.33|0.0921
91498255|NCT02618434|182866530|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.448|TWO_SIDED|95.0|-0.26|0.11|||ANCOVA|||This analysis pertains to the Oppositional Defiant Disorder subscale at Visit 6||0.11|-0.26|0.4480
91498256|NCT02618434|182866530|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.077||0.0457|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||This analysis pertains to the Combined Scale score at Visit 6||-0.00|-0.31|0.0457
91704584|NCT00824382|183303861|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.138|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.095|0.182|||ANCOVA|||Olodaterol 2mcg - Placebo||0.182|0.095|<0.0001
91704585|NCT00824382|183303861|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.197|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.154|0.241|||ANCOVA|||Olodaterol 5mcg - Placebo||0.241|0.154|<0.0001
91704586|NCT00824382|183303861|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.193|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.15|0.236|||ANCOVA|||Olodaterol 10mcg - Placebo||0.236|0.150|<0.0001
91498257|NCT02618434|182866531|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8525|TWO_SIDED|95.0|0.58|1.93|||Regression, Logistic|||This analysis pertains to ≥ 30% Responders.||1.93|0.58|0.8525
91498258|NCT02618434|182866531|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6635|TWO_SIDED|95.0|0.52|1.51|||Regression, Logistic|||This analysis pertains to ≥ 50% Responders.||1.51|0.52|0.6635
91498259|NCT02289898|182866536|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.7158|TWO_SIDED|95.0|0.63|1.375|||Wilcoxon (Mann-Whitney)|||Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.||1.375|0.630|=0.7158
91498260|NCT04626297|182866537|OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|90.0|-10.2|11.2||||||||11.2|-10.2|
91498261|NCT04626297|182866538|OTHER||Risk Difference (RD)|12.2|||||TWO_SIDED|90.0|2.5|22.0||||||||22.0|2.5|
91498262|NCT04626297|182866539|OTHER||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|10.3|33.2|||Cochran-Mantel-Haenszel|||||33.2|10.3|<0.001
91498263|NCT04626297|182866540|OTHER||Risk Difference (RD)|25.3|||<|0.001|TWO_SIDED|95.0|12.6|38.0|||Cochran-Mantel-Haenszel|||||38|12.6|<0.001
91498264|NCT04626297|182866541|OTHER||Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.0|31.6|||Cochran-Mantel-Haenszel|||||31.6|9.0|<0.001
91498265|NCT04626297|182866542|OTHER||Risk Difference (RD)|11.9||||0.138|TWO_SIDED|95.0|-3.8|27.5|||Cochran-Mantel-Haenszel|||||27.5|-3.8|0.138
91498266|NCT04626297|182866543|OTHER||LS Mean Difference|-8.21|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-13.04|-3.39|||Mixed Models Analysis||The mixed model repeated measures (MMRM) included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score as fixed factors.|||-3.39|-13.04|<0.001
91498267|NCT04626297|182866544|OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.152||0.001658|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001658
91498268|NCT02598076|182866554|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
91498269|NCT02598076|182866555|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||||||0.034
91498270|NCT02598076|182866556|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
91498271|NCT02598076|182866557|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
91498272|NCT02598076|182866558|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
91498273|NCT00010374|182866560|OTHER|Performance goal of 35%|Exact two-sided binomial test|96.2|||<|0.001|TWO_SIDED|95.0|87.0|99.5|||Exact two-sided binomial test|||||99.5|87.0|<0.001
91498274|NCT01669915|182866563|SUPERIORITY||Mean Difference (Net)|0.01||||0.31|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.31
91498275|NCT01669915|182866563|SUPERIORITY||Mean Difference (Net)|-0.01||||0.14|TWO_SIDED|95.0|-0.02|0.003|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 fatty acids active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.003|-0.02|0.14
91498276|NCT01669915|182866564|SUPERIORITY||Mean Difference (Net)|0.01||||0.49|TWO_SIDED|95.0|-0.01|0.03||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.03|-0.01|0.49
91736763|NCT02949011|183366956|SUPERIORITY||Median Difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-42.8|-14.6||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The primary analysis of the primary endpoint was a comparison between the baloxavir marboxil and placebo groups.||-14.6|-42.8|<0.0001
91498277|NCT01669915|182866564|SUPERIORITY||Mean Difference (Net)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.002|-0.04|0.03
91498278|NCT01669915|182866565|SUPERIORITY||Mean Difference (Net)|0.01||||0.23|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.23
91498279|NCT01669915|182866565|SUPERIORITY||Mean Difference (Net)|0.003||||0.68|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization)||0.02|-0.01|0.68
91498280|NCT01669915|182866566|SUPERIORITY||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.04|0.09||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.09|-0.04|0.46
91498281|NCT01669915|182866566|SUPERIORITY||Mean Difference (Net)|-0.1||||0.003|TWO_SIDED|95.0|-0.17|-0.04||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.04|-0.17|0.003
91498282|NCT03530098|182866567|SUPERIORITY||Odds Ratio (OR)|-0.59||||0.04|TWO_SIDED|95.0|-1.14|-0.04|||t-test, 2 sided|||||-0.04|-1.14|0.04
91498283|NCT03530098|182866568|OTHER|||||||0.001|||||||Wilcoxon rank-sum test|||||||0.001
91498284|NCT00533845|182866569|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||t-test, 2 sided|||||||.0022
91498285|NCT00667368|182866655|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9||||0.754|TWO_SIDED|95.0|-12.0|10.1|||Two-sample test, Poisson||The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years.|||10.1|-12.0|0.754
91498286|NCT00667368|182866656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91498287|NCT01683383|182866664|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Adjusted Wald estimation|||||||<0.001
91498288|NCT01683383|182866665|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91736764|NCT02949011|183366956|SUPERIORITY||Median Difference|-7.7||||0.8347|TWO_SIDED|95.0|-22.7|7.9||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The comparison between the baloxavir marboxil and the oseltamivir groups was conducted as a secondary analysis only if a statistically significant difference was observed in the primary analysis in order to maintain control of overall type I error.||7.9|-22.7|0.8347
91736765|NCT02949011|183366956|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.0008
91736766|NCT02949011|183366956|SUPERIORITY|||||||0.8449||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.8449
91736767|NCT02949011|183366957|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
91736768|NCT02949011|183366957|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
91736769|NCT02949011|183366957|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
91736770|NCT02949011|183366957|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
91736771|NCT02949011|183366957|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||<0.0001
91736772|NCT02949011|183366957|SUPERIORITY|||||||0.0044||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0044
91736773|NCT02949011|183366957|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||<0.0001
91736774|NCT02949011|183366957|SUPERIORITY|||||||0.1146||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.1146
91736775|NCT02949011|183366957|SUPERIORITY|||||||0.0046||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0046
91736776|NCT02949011|183366957|SUPERIORITY|||||||0.441||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.441
91736777|NCT02949011|183366957|SUPERIORITY|||||||0.0929||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0929
91736778|NCT02949011|183366957|SUPERIORITY|||||||0.0907||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0907
91736779|NCT02949011|183366958|SUPERIORITY|||||||0.7383||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.7383
91736780|NCT02949011|183366958|SUPERIORITY|||||||0.9619||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.9619
91736781|NCT02949011|183366958|SUPERIORITY|||||||0.0576||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0576
91736782|NCT02949011|183366958|SUPERIORITY|||||||0.1237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.1237
91736783|NCT02949011|183366958|SUPERIORITY|||||||0.3071||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.3071
91736784|NCT02949011|183366958|SUPERIORITY|||||||0.9603||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9603
91498289|NCT01683383|182866667|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91498290|NCT02850965|182866670|EQUIVALENCE|Protocol defined margins are: \[-18.0%, +18.0%\] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set.|Difference in PASI 75 Response Rate|-2.2|||||TWO_SIDED|95.0|-14.4|8.7|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|8.7|-14.4|
91498291|NCT02850965|182866671|OTHER|Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in PASI 75 Response Rate|2.9|||||TWO_SIDED|95.0|-8.5|12.6|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 24 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|12.6|-8.5|
91498292|NCT02850965|182866672|OTHER||Difference of Least Squares Means|1.7|||||TWO_SIDED|95.0|-2.7|6.0|||ANCOVA|Analysis of covariance (ANCOVA)|Difference of Least Squares Means (LSM)= LSM of (BI 695501 - Humira)|Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.||6.0|-2.7|
91498293|NCT02850965|182866673|OTHER|Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in sPGA <= 1 Response Rate|7.5|||||TWO_SIDED|95.0|-4.8|19.1|||Regression, Logistic||Difference in sPGA \<= 1 Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|19.1|-4.8|
91530900|NCT00518713|182937840|SUPERIORITY_OR_OTHER|||||||0.1469||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1469
91530901|NCT00518713|182937840|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0161
91530902|NCT00518713|182937840|SUPERIORITY_OR_OTHER|||||||0.0024||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0024
91530903|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.1324||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1324
91530904|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0026
91736785|NCT02949011|183366958|SUPERIORITY|||||||0.0784||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0784
91498294|NCT02850965|182866674|OTHER|Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in DLQI Response Rate|0.4|||||TWO_SIDED|95.0|-11.7|11.3|||Regression, Logistic||Difference in DLQI (0, 1) Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|11.3|-11.7|
91498295|NCT03178903|182866689|SUPERIORITY||Mean Difference (Final Values)|0.678||||0.87|TWO_SIDED|||||p\<.05 was the a priori threshold for statistical significance.|ANCOVA|Covarying for baseline depressive symptoms and MVPA.||||||.87
91530905|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0004
91530906|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.3383||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.3383
91530907|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.0159||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0159
91530908|NCT00518713|182937841|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
91498296|NCT01897402|182866722|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.6|||||TWO_SIDED|95.0|-7.9|9.1|||||Serogroup A|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-7.9|
91498297|NCT01897402|182866722|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-6.0|||||TWO_SIDED|95.0|-14.6|2.6|||||Serogroup C|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||2.6|-14.6|
91704587|NCT00824382|183303862|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.146|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.101|0.191|||ANCOVA|||Olodaterol 2mcg - Placebo||0.191|0.101|<0.0001
91704588|NCT00824382|183303862|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.202|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.157|0.247|||ANCOVA|||Olodaterol 5mcg - Placebo||0.247|0.157|<0.0001
91704589|NCT00824382|183303862|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.196|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.151|0.24|||ANCOVA|||Olodaterol 10mcg - Placebo||0.240|0.151|<0.0001
91704590|NCT00824382|183303863|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.107|0.275|||ANCOVA|||Olodaterol 2mcg - Placebo||0.275|0.107|<0.0001
91704591|NCT00824382|183303863|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.106|0.276|||ANCOVA|||Olodaterol 5mcg - Placebo||0.276|0.106|<0.0001
91704592|NCT00824382|183303863|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.187|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.103|0.27|||ANCOVA|||Olodaterol 10mcg - Placebo||0.270|0.103|<0.0001
91704593|NCT00824382|183303864|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.16|0.345|||ANCOVA|||Olodaterol 2mcg - Placebo||0.345|0.160|<0.0001
91704594|NCT00824382|183303864|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.25|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.156|0.343|||ANCOVA|||Olodaterol 5mcg - Placebo||0.343|0.156|<0.0001
91704595|NCT00824382|183303864|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.233|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.141|0.325|||ANCOVA|||Olodaterol 10mcg - Placebo||0.325|0.141|<0.0001
91704596|NCT00824382|183303865|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.155|0.351|||ANCOVA|||Olodaterol 2mcg - Placebo||0.351|0.155|<0.0001
91704597|NCT00824382|183303865|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.242|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.142|0.341|||ANCOVA|||Olodaterol 5mcg - Placebo||0.341|0.142|<0.0001
91704598|NCT00824382|183303865|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.226|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.324|||ANCOVA|||Olodaterol 10mcg - Placebo||0.324|0.129|<0.0001
91704599|NCT00824382|183303866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.039||0.0045||95.0|0.035|0.188|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.188|0.035|0.0045
91704600|NCT00824382|183303866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.14|0.293|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.293|0.140|<0.0001
91704601|NCT00824382|183303866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.142|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.292|0.142|<0.0001
91704602|NCT00824382|183303867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.039||0.0348||95.0|0.006|0.159|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.159|0.006|0.0348
91704603|NCT00824382|183303867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.1|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.100|<0.0001
91704604|NCT00824382|183303867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.115|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.265|0.115|<0.0001
91704605|NCT00824382|183303868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.256|STANDARD_ERROR_OF_MEAN|5.476|<|0.0001||95.0|16.477|38.036|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||38.036|16.477|<0.0001
91704606|NCT00824382|183303868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.383|STANDARD_ERROR_OF_MEAN|5.574|<|0.0001||95.0|18.41|40.357|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||40.357|18.410|<0.0001
91704607|NCT00824382|183303868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.678|STANDARD_ERROR_OF_MEAN|5.431|<|0.0001||95.0|25.987|47.369|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.369|25.987|<0.0001
91704608|NCT00824382|183303869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.052|STANDARD_ERROR_OF_MEAN|5.534|<|0.0001||95.0|18.159|39.946|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||39.946|18.159|<0.0001
91498298|NCT01897402|182866722|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-9.9|7.9|||||Serogroup Y|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||7.9|-9.9|
91498299|NCT01897402|182866722|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-8.5|9.1|||||Serogroup W-135|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-8.5|
91498300|NCT00580606|182866735|SUPERIORITY_OR_OTHER||Risk Difference (RD)|55.0|||<|0.001|TWO_SIDED|95.0|22.2|77.6||No adjustments were made to the p-value.|Barnard's Statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.||77.6|22.2|<0.001
91498301|NCT01482884|182866760|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.8||||0.4062|TWO_SIDED|95.0|-13.0|22.5||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.||22.5|-13.0|0.4062
91530909|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0279
91704609|NCT00824382|183303869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.955|STANDARD_ERROR_OF_MEAN|5.635|<|0.0001||95.0|19.861|42.049|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||42.049|19.861|<0.0001
91704610|NCT00824382|183303869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.191|STANDARD_ERROR_OF_MEAN|5.489|<|0.0001||95.0|26.386|47.996|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.996|26.386|<0.0001
91704611|NCT00824382|183303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|STANDARD_ERROR_OF_MEAN|0.149||0.2016||95.0|-0.485|0.103|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.103|-0.485|0.2016
91704612|NCT00824382|183303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.454|STANDARD_ERROR_OF_MEAN|0.151||0.0029||95.0|-0.752|-0.156|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.156|-0.752|0.0029
91704613|NCT00824382|183303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|STANDARD_ERROR_OF_MEAN|0.148||0.0095||95.0|-0.678|-0.095|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.095|-0.678|0.0095
91704614|NCT03003000|183303939|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.3446|TWO_SIDED|95.0|-0.168|0.48||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeated Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline placebo. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with placebo.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix.|0.480|-0.168|0.3446
91704615|NCT03003000|183303939|SUPERIORITY||Mean Difference (Final Values)|-0.129||||0.3358|TWO_SIDED|95.0|-0.392|0.134||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline ibuprofen. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with ibuprofen.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix|0.134|-0.392|0.3358
91704616|NCT03003000|183303940|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.0474|TWO_SIDED|95.0|-0.572|-0.003||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.003|-0.572|0.0474
91498302|NCT01482884|182866761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.3937|TWO_SIDED|95.0|-1.63|0.65|||ANCOVA|Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.||||0.65|-1.63|0.3937
91498303|NCT01482884|182866762|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.1043|TWO_SIDED|95.0|-4.0|28.3||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||28.3|-4.0|0.1043
91498304|NCT01482884|182866763|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.0326|TWO_SIDED|95.0|0.7|24.1||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||24.1|0.7|0.0326
91498305|NCT01482884|182866765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.449|TWO_SIDED|95.0|-0.41|0.91|||ANCOVA|Modified Riley score at baseline as a covariate, and treatment as factors in the model.||||0.91|-0.41|0.4490
91498306|NCT04853225|182866839|OTHER||Adjusted rate of change|-59.46|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91530910|NCT00518713|182937841|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0010
91704617|NCT03003000|183303940|SUPERIORITY||Mean Difference (Final Values)|0.051||||0.6658|TWO_SIDED|95.0|-0.18|0.282||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine.|||0.282|-0.180|0.6658
91498307|NCT04853225|182866839|OTHER||Adjusted rate of change|-62.73|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498308|NCT04853225|182866839|OTHER||Adjusted rate of change|-48.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498309|NCT04853225|182866839|OTHER||Adjusted rate of change|-50.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498310|NCT04853225|182866839|OTHER||Adjusted rate of change|-22.67|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498311|NCT04853225|182866839|OTHER||Adjusted rate of change|-33.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498312|NCT04853225|182866839|OTHER||Adjusted rate of change|-20.4|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498313|NCT04853225|182866839|OTHER||Adjusted rate of change|-31.08|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498314|NCT04853225|182866839|OTHER||Adjusted rate of change|-64.74|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498315|NCT04853225|182866839|OTHER||Adjusted rate of change|-60.26|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498316|NCT04853225|182866839|OTHER||Adjusted rate of change|-27.85|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91530911|NCT00518713|182937841|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
91498317|NCT04853225|182866839|OTHER||Adjusted rate of change|-28.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498318|NCT04853225|182866840|OTHER||Adjusted rate of change|-87.47|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91704618|NCT03003000|183303941|SUPERIORITY||Mean Difference (Final Values)|-0.399||||0.0091|TWO_SIDED|95.0|-0.698|-0.1||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.100|-0.698|0.0091
91704619|NCT03003000|183303941|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.6387|TWO_SIDED|95.0|-0.185|0.302||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine|||0.302|-0.185|0.6387
91498319|NCT04853225|182866840|OTHER||Adjusted rate of change|-83.25|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498320|NCT04853225|182866840|OTHER||Adjusted rate of change|-77.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498321|NCT04853225|182866840|OTHER||Adjusted rate of change|-77.41|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498322|NCT04853225|182866840|OTHER||Adjusted rate of change|-60.1|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498323|NCT04853225|182866840|OTHER||Adjusted rate of change|-73.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498324|NCT04853225|182866840|OTHER||Adjusted rate of change|-45.44|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498325|NCT04853225|182866840|OTHER||Adjusted rate of change|-79.49|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498326|NCT04853225|182866840|OTHER||Adjusted rate of change|-74.39|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498327|NCT04853225|182866840|OTHER||Adjusted rate of change|-63.04|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498328|NCT04853225|182866840|OTHER||Adjusted rate of change|-25.59|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498329|NCT04853225|182866840|OTHER||Adjusted rate of change|-38.69|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
91498330|NCT03789318|182866841|SUPERIORITY|||||||0.2912|||||||ANOVA|||||||0.2912
91498331|NCT03789318|182866842|SUPERIORITY|||||||0.498|||||||ANOVA|||||||0.4980
91498332|NCT03789318|182866843|SUPERIORITY|||||||0.1958|||||||Log Rank|||||||0.1958
91498333|NCT03789318|182866844|SUPERIORITY|||||||0.9546|||||||Regression, Logistic|||||||0.9546
91498334|NCT03789318|182866845|SUPERIORITY|||||||0.4434|||||||ANOVA|||||||0.4434
91498335|NCT01134783|182866853|SUPERIORITY_OR_OTHER|||||||0.707|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.707
91498336|NCT01134783|182866854|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.049
91498337|NCT04346537|182866861|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
91498338|NCT04346537|182866862|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
91498339|NCT04346537|182866863|OTHER|Two-one sided t-tests (TOST) -- the 90% confidence interval was required to be contained with 300 and 1300 ohms.|||||<|0.001|||||||Two one-sided t-tests|||||||< 0.001
91704620|NCT03003000|183303942|SUPERIORITY||Mean Difference (Final Values)|0.559||||0.4398|TWO_SIDED|95.0|-0.861|1.979||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect model for repeated measures||Adjusted mean change ibuprofen and caffeine - Adjusted mean change placebo. A negative result favors ibuprofen and caffeine.|Mixed effect model for repeated measures (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.979|-0.861|0.4398
91704621|NCT03003000|183303942|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.7911|TWO_SIDED|95.0|-1.002|1.314||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine.|MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.314|-1.002|0.7911
91704622|NCT03003000|183303943|SUPERIORITY||Odds Ratio (OR)|1.777||||0.0045|TWO_SIDED|95.0|1.195|2.642||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||2.642|1.195|0.0045
91704623|NCT03003000|183303943|SUPERIORITY||Odds Ratio (OR)|1.008||||0.9603|TWO_SIDED|95.0|0.732|1.389||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||1.389|0.732|0.9603
91704624|NCT03003000|183303944|SUPERIORITY||Odds Ratio (OR)|1.028||||0.9022|TWO_SIDED|95.0|0.663|1.592||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.592|0.663|0.9022
91498340|NCT01991067|182866894|OTHER|Furthermore, a multivariable logistic regression model was applied accounting for group as well as age, body mass index, and gender as possible influence factors.|||||<|0.001||||||The threshold for statistical significance was a p-value of \<0.05.|Fisher Exact|||The calculation of the sample size was performed using nQuery 6.1. The primary endpoint was the outcome of the NT 4 weeks after the second vaccination. A Fisher exact tes was calculated to analyze the primary hypothesis on the difference in NT-titer response between patients and controls||||<0.001
91498341|NCT01991067|182866895|OTHER|||||||0.02|||||||Fisher Exact|||A Fisher exact test was calculated to analyze antibody response by ELISA between patients and controls. To measure the Agreement between the NT and ELISA response, Cohens Kappa and the corresponding 95% confidence interval were calculated||||0.02
91530912|NCT00518713|182937848|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.7210
91498342|NCT01991067|182866896|OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"For titer values the geometric mean was calculated and the corresponding two-sided 95% confidence intervals were constructed by back-transfomration of the CI for the mean of the logarithmically transformed results.~To investigate the difference in absolute titer values and geometric mean fold changes between time point and Groups, Wilcoxon tests were performed."||||<0.01
91736786|NCT02949011|183366958|SUPERIORITY|||||||0.5547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5547
91736787|NCT02949011|183366958|SUPERIORITY|||||||0.3087||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.3087
91736788|NCT02949011|183366958|SUPERIORITY|||||||0.9106||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9106
91736789|NCT02949011|183366958|SUPERIORITY|||||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0017
91736790|NCT02949011|183366958|SUPERIORITY|||||||0.3068||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.3068
91736791|NCT02949011|183366959|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
91736792|NCT02949011|183366959|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
91736793|NCT02949011|183366959|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
91736794|NCT02949011|183366959|SUPERIORITY|||||||0.0024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0024
91498343|NCT00127712|182866908|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
91498344|NCT00127712|182866909|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91498345|NCT00127712|182866910|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
91736795|NCT02949011|183366959|SUPERIORITY|||||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ven Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9127
91498346|NCT00127712|182866911|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
91736796|NCT02949011|183366959|SUPERIORITY|||||||0.5361||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.5361
91736797|NCT02949011|183366959|SUPERIORITY|||||||0.5739||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5739
91736798|NCT02949011|183366959|SUPERIORITY|||||||0.5466||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5466
91736799|NCT02949011|183366959|SUPERIORITY|||||||0.0543||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0543
91736800|NCT02949011|183366959|SUPERIORITY|||||||0.4677||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.4677
91736801|NCT02949011|183366959|SUPERIORITY|||||||0.0266||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0266
91736802|NCT02949011|183366959|SUPERIORITY|||||||0.1281||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.1281
91736803|NCT02949011|183366960|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
91498347|NCT00799487|182866922|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-20.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.2|-34.4|<0.0001
91498348|NCT00799487|182866923|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.1|-20.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.8|-35.1|<0.0001
91498349|NCT00799487|182866924|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0|||<|0.0001|TWO_SIDED|95.0|3.4|6.6||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||6.6|3.4|<0.0001
91498350|NCT00799487|182866925|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.2|5.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||5.8|3.2|<0.0001
91736804|NCT02949011|183366960|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
91736805|NCT02949011|183366960|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
91736806|NCT02949011|183366960|SUPERIORITY|||||||0.0015||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0015
91736807|NCT02949011|183366960|SUPERIORITY|||||||0.0028||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0028
91498351|NCT00799487|182866926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|9.5|||<|0.0001|TWO_SIDED|95.0|6.9|12.0||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||12.0|6.9|<0.0001
91498352|NCT00799487|182866927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51|||<|0.0001|TWO_SIDED|95.0|-4.27|-2.74||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-2.74|-4.27|<0.0001
91498353|NCT00799487|182866928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.58|||<|0.0001|TWO_SIDED|95.0|-23.72|-11.45||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.45|-23.72|<0.0001
91498354|NCT00799487|182866929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.33|||<|0.0001|TWO_SIDED|95.0|-39.29|-21.37||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-21.37|-39.29|<0.0001
91530913|NCT00518713|182937848|SUPERIORITY_OR_OTHER|||||||0.2505||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2505
91736808|NCT02949011|183366960|SUPERIORITY|||||||0.0265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0265
91736809|NCT02949011|183366960|SUPERIORITY|||||||0.0247||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0247
91736810|NCT02949011|183366960|SUPERIORITY|||||||0.5298||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5298
91736811|NCT02949011|183366960|SUPERIORITY|||||||0.9554||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9554
91736812|NCT02949011|183366960|SUPERIORITY|||||||0.9075||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9075
91736813|NCT02949011|183366960|SUPERIORITY|||||||0.7624||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.7624
91736814|NCT02949011|183366960|SUPERIORITY|||||||0.6156||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.6156
91736815|NCT02949011|183366961|SUPERIORITY|||||||0.034||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0340
91736816|NCT02949011|183366961|SUPERIORITY|||||||0.2766||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.2766
91736817|NCT02949011|183366962|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0072
91736818|NCT02949011|183366962|SUPERIORITY|||||||0.733||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.7330
91498355|NCT00799487|182866930|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13||||0.0297|TWO_SIDED|95.0|-2.15|-0.12||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.12|-2.15|0.0297
91498356|NCT00799487|182866931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0955|TWO_SIDED|95.0|-1.84|0.15||P-values were determined by using a general linear mixed model. Finger Windows Forwards was the first non-significant p-value in the gatekeeper sequence.|Mixed Models Analysis|Testing of additional endpoints in the sequence was still performed without any unqualified statements about the individual statistical significance.|Placebo minus Concerta|||0.15|-1.84|0.0955
91736819|NCT02949011|183366963|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-48.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-48.0|-48.0|<0.0001
91736820|NCT02949011|183366963|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-24.0|-48.0|<0.0001
91736821|NCT02949011|183366964|SUPERIORITY||Median Difference|-24.0||||0.0006|TWO_SIDED|95.0|-96.0|0.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||0.0|-96.0|0.0006
91736822|NCT02949011|183366964|SUPERIORITY||Median Difference|0.0||||0.237|TWO_SIDED|95.0|-48.0|24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||24.0|-48.0|0.2370
91736823|NCT02949011|183366965|SUPERIORITY|||||||0.7698||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.7698
91736824|NCT02949011|183366965|SUPERIORITY|||||||0.5777||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.5777
91498357|NCT00799487|182866932|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.37||||0.0002|TWO_SIDED|95.0|-21.52|-7.23||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-7.23|-21.52|0.0002
91498358|NCT00799487|182866933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26||||0.2335|TWO_SIDED|95.0|-0.7|0.17||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.17|-0.70|0.2335
91736825|NCT02949011|183366965|SUPERIORITY|||||||0.1112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.1112
91736826|NCT02949011|183366965|SUPERIORITY|||||||0.6483||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.6483
91736827|NCT02949011|183366965|SUPERIORITY|||||||0.0004||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.0004
91736828|NCT02949011|183366965|SUPERIORITY|||||||0.5625||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.5625
91736829|NCT02949011|183366965|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.0072
91736830|NCT02949011|183366965|SUPERIORITY|||||||0.6234||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.6234
91736831|NCT02949011|183366965|SUPERIORITY|||||||0.0002||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0002
91736832|NCT02949011|183366965|SUPERIORITY|||||||0.9547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.9547
91736833|NCT02949011|183366965|SUPERIORITY|||||||0.0012||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0012
91736834|NCT02949011|183366965|SUPERIORITY|||||||0.186||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.1860
91736835|NCT02949011|183366965|SUPERIORITY|||||||0.0274||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.0274
91736836|NCT02949011|183366965|SUPERIORITY|||||||0.9635||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.9635
91498359|NCT00799487|182866934|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.51||||0.2321|TWO_SIDED|95.0|-6.67|1.65||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||1.65|-6.67|0.2321
91498360|NCT00799487|182866935|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.52||||0.0015|TWO_SIDED|95.0|-5.64|-1.4||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.40|-5.64|0.0015
91736837|NCT02949011|183366965|SUPERIORITY|||||||0.0081||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.0081
91736838|NCT02949011|183366965|SUPERIORITY|||||||0.7425||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.7425
91736839|NCT02949011|183366965|SUPERIORITY|||||||0.0209||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.0209
91736840|NCT02949011|183366965|SUPERIORITY|||||||0.7448||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7448
91498361|NCT00799487|182866936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.38||||0.0101|TWO_SIDED|95.0|-9.43|-1.33||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.33|-9.43|0.0101
91498362|NCT00799487|182866937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09||||0.6642|TWO_SIDED|95.0|-0.53|0.34||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.34|-0.53|0.6642
91498363|NCT00799487|182866938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3||||0.004|TWO_SIDED|95.0|-58.89|-11.71||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.71|-58.89|0.0040
91498364|NCT00799487|182866939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08||||0.0012|TWO_SIDED|95.0|-0.14|-0.03||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.03|-0.14|0.0012
91498365|NCT00799487|182866940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07||||0.0051|TWO_SIDED|95.0|-0.12|-0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.02|-0.12|0.0051
91498366|NCT00799487|182866941|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05||||0.1768|TWO_SIDED|95.0|-0.13|0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.02|-0.13|0.1768
91498367|NCT00799487|182866942|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02||||0.4245|TWO_SIDED|95.0|-0.09|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.09|0.4245
91736841|NCT02949011|183366965|SUPERIORITY|||||||0.0644||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.0644
91736842|NCT02949011|183366965|SUPERIORITY|||||||0.4931||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4931
91736843|NCT02949011|183366965|SUPERIORITY|||||||0.0708||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.0708
91736844|NCT02949011|183366965|SUPERIORITY|||||||0.4024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.4024
91736845|NCT02949011|183366966|SUPERIORITY||Median Difference|-25.8|||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||<0.0001
91736846|NCT02949011|183366966|SUPERIORITY||Median Difference|-8.6||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9127
91736847|NCT02949011|183366967|SUPERIORITY||Median Difference|-15.1||||0.0013||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0013
91736848|NCT02949011|183366967|SUPERIORITY||Median Difference|2.3||||0.8498||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.8498
91736849|NCT02949011|183366968|SUPERIORITY||Median Difference|-24.1||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0001
91498368|NCT00799487|182866943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.0||||0.9729|TWO_SIDED|95.0|-0.09|0.09||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.09|-0.09|0.9729
91498369|NCT00799487|182866944|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04||||0.3486|TWO_SIDED|95.0|-0.12|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.12|0.3486
91498370|NCT00799487|182866945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03||||0.1466|TWO_SIDED|95.0|-0.07|0.01||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.01|-0.07|0.1466
91736850|NCT02949011|183366968|SUPERIORITY||Median Difference|1.5||||0.9237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9237
91736851|NCT02949011|183366969|SUPERIORITY||Median Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-28.8|-12.5||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||-12.5|-28.8|<0.0001
91736852|NCT02949011|183366969|SUPERIORITY||Median Difference|-3.5||||0.2425|TWO_SIDED|95.0|-9.1|2.7||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||2.7|-9.1|0.2425
91736853|NCT02949011|183366970|SUPERIORITY|||||||0.1713||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.1713
91736854|NCT02949011|183366970|SUPERIORITY|||||||0.2249||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.2249
91736855|NCT02949011|183366970|SUPERIORITY|||||||0.0387||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.0387
91530914|NCT00518713|182937848|SUPERIORITY_OR_OTHER|||||||0.0924||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0924
91736856|NCT02949011|183366970|SUPERIORITY|||||||0.3915||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.3915
91736857|NCT02949011|183366970|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||<0.0001
91736858|NCT02949011|183366970|SUPERIORITY|||||||0.2617||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.2617
91736859|NCT02949011|183366970|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||<0.0001
91736860|NCT02949011|183366970|SUPERIORITY|||||||0.8808||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.8808
91736861|NCT02949011|183366970|SUPERIORITY|||||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0001
91736862|NCT02949011|183366970|SUPERIORITY|||||||0.5923||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.5923
91736863|NCT02949011|183366970|SUPERIORITY|||||||0.0064||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0064
91736864|NCT02949011|183366970|SUPERIORITY|||||||0.6746||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.6746
91736865|NCT02949011|183366970|SUPERIORITY|||||||0.8167||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.8167
91736866|NCT02949011|183366970|SUPERIORITY|||||||0.3773||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.3773
91736867|NCT02949011|183366970|SUPERIORITY|||||||0.1041||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.1041
91498371|NCT00799487|182866946|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03||||0.1368|TWO_SIDED|95.0|-0.01|0.08||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.08|-0.01|0.1368
91498372|NCT00356369|182867027|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (\>) -15%.|Difference in % for rSBA-MenA antibodies|13.0|||||TWO_SIDED|95.0|3.52|23.5||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||23.5|3.52|
91498373|NCT00356369|182867027|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenC antibodies|4.18|||||TWO_SIDED|95.0|-1.03|11.36||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.36|-1.03|
91498374|NCT00356369|182867027|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in%for rSBA-MenW-135 antibody|4.58|||||TWO_SIDED|95.0|-0.07|11.49||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.49|-0.07|
91498375|NCT00356369|182867027|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenY antibodies|8.05|||||TWO_SIDED|95.0|1.72|16.17||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||16.17|1.72|
91736868|NCT02949011|183366970|SUPERIORITY|||||||0.3328||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.3328
91498376|NCT00356369|182867028|NON_INFERIORITY|Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.|Difference in % Grade 3 general symptoms|1.34|||||TWO_SIDED|95.0|-1.64|3.09||||||To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.||3.09|-1.64|
91498377|NCT00673465|182867059|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.4||||0.5269|TWO_SIDED|95.0|-18.5|9.7|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||9.7|-18.5|0.5269
91498378|NCT00673465|182867059|SUPERIORITY_OR_OTHER||Difference in least squares mean|-53.9|||<|0.0001|TWO_SIDED|95.0|-68.1|-39.8|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-39.8|-68.1|<0.0001
91498379|NCT00673465|182867063|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.81||||0.741|TWO_SIDED|95.0|-20.1|14.5|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||14.5|-20.1|0.7410
91498380|NCT00673465|182867063|SUPERIORITY_OR_OTHER||Difference in least squares mean|-63.6|||<|0.0001|TWO_SIDED|95.0|-80.9|-46.2|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-46.2|-80.9|<0.0001
91498381|NCT00673465|182867065|SUPERIORITY_OR_OTHER||Difference in least squares mean|-3.59||||0.3146|TWO_SIDED|95.0|-10.8|3.6|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||3.6|-10.8|0.3146
91498382|NCT00673465|182867065|SUPERIORITY_OR_OTHER||Difference in least squares mean|-26.6|||<|0.0001|TWO_SIDED|95.0|-33.8|-19.4|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-19.4|-33.8|<0.0001
91498383|NCT04294472|182867148|SUPERIORITY|Cohort 1 vs Placebo||||||0.1866|||||||Log Rank|||||||0.1866
91498384|NCT04294472|182867148|SUPERIORITY|Cohort 2 vs Placebo||||||0.2627|||||||Log Rank|||||||0.2627
91498385|NCT04294472|182867149|SUPERIORITY|Cohort 1 vs Placebo||||||0.0639|||||||Log Rank|||||||0.0639
91498386|NCT04294472|182867149|SUPERIORITY|Cohort 2 vs Placebo||||||0.0508|||||||Log Rank|||||||0.0508
91498387|NCT00563381|182867150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83|||<|0.0001||95.0|0.77|0.9|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.90|0.77|<0.0001
91498388|NCT00563381|182867151|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.73|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.66|0.82|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium vs. Salmeterol||0.82|0.66|<0.0001
91498389|NCT00563381|182867152|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0002||95.0|0.85|0.95|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.95|0.85|0.0002
91498390|NCT00563381|182867153|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0017||95.0|0.83|0.96|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.96|0.83|0.0017
91498391|NCT00563381|182867154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.0001||95.0|0.61|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.61|<0.0001
91498392|NCT00563381|182867155|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.0005||95.0|0.66|0.89|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.89|0.66|0.0005
91498393|NCT00563381|182867156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0242||95.0|0.78|0.98|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.98|0.78|0.0242
91498394|NCT00563381|182867157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0406||95.0|0.82|1.0|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||1.00|0.82|0.0406
91498395|NCT00563381|182867158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001||95.0|0.78|0.91|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.91|0.78|<0.0001
91736869|NCT02949011|183366970|SUPERIORITY|||||||0.7867||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7867
91498396|NCT00563381|182867159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001||95.0|0.69|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.69|<0.0001
91498397|NCT00563381|182867160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||<|0.0001||95.0|0.78|0.92|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.92|0.78|<0.0001
91498398|NCT00563381|182867161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.68|0.86|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.86|0.68|<0.0001
91498399|NCT00563381|182867162|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.82|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.76|0.9|||Poisson regression|Poisson regression correcting for overdispersion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.90|0.76|<0.0001
91498400|NCT00563381|182867163|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.9|STANDARD_ERROR_OF_MEAN|0.03||0.0036||95.0|0.84|0.97|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.97|0.84|0.0036
91498401|NCT00563381|182867164|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.8|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.73|0.88|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.88|0.73|<0.0001
91498402|NCT00563381|182867165|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.6||||0.1035||95.0|-3.53|0.33|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.33|-3.53|0.1035
91498403|NCT00563381|182867166|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.06||||0.0369||95.0|-3.99|-0.12|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week).||Tiotropium versus Salmeterol||-0.12|-3.99|0.0369
91498404|NCT00563381|182867167|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.07||||0.0362||95.0|-4.0|-0.13|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||-0.13|-4.00|0.0362
91498405|NCT00563381|182867168|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.88||||0.0573||95.0|-3.82|0.06|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.06|-3.82|0.0573
91498406|NCT00563381|182867169|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2641||95.0|-3.04|0.83|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.83|-3.04|0.2641
91498407|NCT00563381|182867170|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.01||||0.3068||95.0|-2.95|0.93|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.93|-2.95|0.3068
91498408|NCT00563381|182867171|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.78||||0.4299||95.0|-2.72|1.16|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.16|-2.72|0.4299
91530915|NCT00518713|182937849|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0414
91498409|NCT00563381|182867172|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.48||||0.6277||95.0|-2.42|1.46|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.46|-2.42|0.6277
91498410|NCT00563381|182867173|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.85||||0.3931||95.0|-2.8|1.1|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.10|-2.80|0.3931
91498411|NCT00563381|182867174|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.97||||0.3297||95.0|-2.92|0.98|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.98|-2.92|0.3297
91498412|NCT00563381|182867175|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.3||||0.1904||95.0|-3.25|0.65|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.65|-3.25|0.1904
91498413|NCT00563381|182867176|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.99||||0.3172||95.0|-2.94|0.95|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.95|-2.94|0.3172
91498414|NCT00563381|182867177|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.67||||0.5017||95.0|-2.62|1.28|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.28|-2.62|0.5017
91498415|NCT00563381|182867178|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.23||||0.2174||95.0|-3.18|0.72|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.72|-3.18|0.2174
91498416|NCT00563381|182867179|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2682||95.0|-3.05|0.85|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.85|-3.05|0.2682
91498417|NCT00563381|182867180|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.59||||0.552||95.0|-2.55|1.36|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.36|-2.55|0.5520
91498418|NCT04044716|182867185|SUPERIORITY|||||||0.048|||||||ANCOVA|age, joint involved in surgery, sex, baseline pain||||||.048
91498419|NCT04044716|182867186|SUPERIORITY|||||||0.29|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline pain||||||0.29
91498420|NCT04044716|182867187|SUPERIORITY|||||||0.64|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline morphine milligram equivalents (MME)||||||0.64
91498421|NCT04044716|182867188|SUPERIORITY|||||||0.86|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline MME, and time in hospital||||||0.86
91704625|NCT03003000|183303944|SUPERIORITY||Odds Ratio (OR)|0.834||||0.3129|TWO_SIDED|95.0|0.586|1.187||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.187|0.586|0.3129
91498422|NCT04044716|182867189|SUPERIORITY|||||||0.661||||||adjusted for age, type of surgery (joint), and sex|ANCOVA|||||||0.661
91498423|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|2.55|6.46|||||Ratio of GMTs at Day 22|||6.46|2.55|
91498424|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.25|||||TWO_SIDED|95.0|1.42|3.56|||||Ratio of GMTs at Day 22|||3.56|1.42|
91704626|NCT03003000|183303944|SUPERIORITY||Odds Ratio (OR)|1.354||||0.3301|TWO_SIDED|95.0|0.736|2.494||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|2.494|0.736|0.3301
91704627|NCT03003000|183303944|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0864|TWO_SIDED|95.0|0.437|1.057||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.057|0.437|0.0864
91704628|NCT03003000|183303945|SUPERIORITY|||||||0.9384||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.9384
91498425|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.49|||||TWO_SIDED|95.0|2.8|7.19|||||Ratio of GMTs at Day 22|||7.19|2.8|
91498426|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.49|||||TWO_SIDED|95.0|1.56|3.96|||||Ratio of GMTs at Day 22|||3.96|1.56|
91498427|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|8.01|||||TWO_SIDED|95.0|5.52|12.0|||||Ratio of GMTs at Day 43|||12|5.52|
91530916|NCT00518713|182937849|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0044
91704629|NCT03003000|183303945|SUPERIORITY|||||||0.3534||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.3534
91736870|NCT02949011|183366970|SUPERIORITY|||||||0.864||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.8640
91736871|NCT02949011|183366970|SUPERIORITY|||||||0.6465||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.6465
91736872|NCT02949011|183366970|SUPERIORITY|||||||0.4265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4265
91736873|NCT02949011|183366970|SUPERIORITY|||||||0.6568||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6568
91736874|NCT02949011|183366970|SUPERIORITY|||||||0.6102||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6102
91736875|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.0408|TWO_SIDED|95.0|-0.28|-0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||-0.01|-0.28|0.0408
91498428|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.25|||||TWO_SIDED|95.0|2.94|6.15|||||Ratio of GMTs at Day 43|||6.15|2.94|
91498429|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|7.81|||||TWO_SIDED|95.0|5.36|11.0|||||Ratio of GMTs at Day 43|||11|5.36|
91498430|NCT00996307|182867214|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratios of GMTs|4.15|||||TWO_SIDED|95.0|2.86|6.02|||||Ratio of GMTs at Day 43|||6.02|2.86|
91498431|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|3.66|||||TWO_SIDED|95.0|2.37|5.65||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22||5.65|2.37|
91498432|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.21|||||TWO_SIDED|95.0|1.43|3.4||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||3.4|1.43|
91736876|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5324|TWO_SIDED|95.0|-0.18|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||0.09|-0.18|0.5324
91736877|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.3|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||-0.06|-0.30|0.0025
91736878|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4874|TWO_SIDED|95.0|-0.08|0.16||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||0.16|-0.08|0.4874
91736879|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||-0.24|-0.47|<0.0001
91736880|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5414|TWO_SIDED|95.0|-0.15|0.08||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||0.08|-0.15|0.5414
91736881|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.44|-0.22||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||-0.22|-0.44|<0.0001
91736882|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3185|TWO_SIDED|95.0|-0.17|0.05||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||0.05|-0.17|0.3185
91736883|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0025|TWO_SIDED|95.0|-0.26|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||-0.06|-0.26|0.0025
91498433|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.42|||||TWO_SIDED|95.0|2.85|6.86||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||6.86|2.85|
91498434|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.67|||||TWO_SIDED|95.0|1.72|4.13||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||4.13|1.72|
91498435|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.82|||||TWO_SIDED|95.0|5.54|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.54|
91498436|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.55|||||TWO_SIDED|95.0|3.23|6.42||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines||6.42|3.23|
91498437|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.52|||||TWO_SIDED|95.0|5.3|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.3|
91736884|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8299|TWO_SIDED|95.0|-0.09|0.11||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||0.11|-0.09|0.8299
91736885|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.0878|TWO_SIDED|95.0|-0.19|0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.01|-0.19|0.0878
91736886|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7498|TWO_SIDED|95.0|-0.09|0.12||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.12|-0.09|0.7498
91736887|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.803|TWO_SIDED|95.0|-0.11|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.09|-0.11|0.8030
91736888|NCT02949011|183366971|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3577|TWO_SIDED|95.0|-0.05|0.15||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.15|-0.05|0.3577
91736889|NCT02949011|183366972|SUPERIORITY||Median Difference|-23.1||||0.0009||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.0009
91736890|NCT02949011|183366972|SUPERIORITY||Median Difference|-0.2||||0.4074||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.4074
91498438|NCT00996307|182867214|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.37|||||TWO_SIDED|95.0|3.09|6.19||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||6.19|3.09|
91498439|NCT01209260|182867286|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|t-test, 2 sided|||Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.||||0.005
91498440|NCT01209260|182867288|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|Chi-squared|||||||<0.001
91498441|NCT01209260|182867289|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05.|Chi-squared|||||||<0.001
91498442|NCT01648205|182867301|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|26.8||0.7958|TWO_SIDED|95.0|-14.1|11.0|||t-test, 2 sided|Paired t-test was used||||11.0|-14.1|0.7958
91736891|NCT02949011|183366972|SUPERIORITY||Median Difference|-6.3||||0.2496||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2496
91736892|NCT02949011|183366972|SUPERIORITY||Median Difference|0.9||||0.2963||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2963
91736893|NCT02949011|183366972|SUPERIORITY||Median Difference|-10.6||||0.039||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.0390
91736894|NCT02949011|183366972|SUPERIORITY||Median Difference|2.0||||0.7877||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.7877
91736895|NCT02949011|183366972|SUPERIORITY||Median Difference|-12.1||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.0017
91736896|NCT02949011|183366972|SUPERIORITY||Median Difference|1.5||||0.8119||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.8119
91736897|NCT02949011|183366972|SUPERIORITY||Median Difference|-3.6||||0.007||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.0070
91498443|NCT01648205|182867302|SUPERIORITY||Median Difference (Final Values)|8.4|STANDARD_DEVIATION|35.9||0.3369|TWO_SIDED|95.0|-9.5|26.2|||t-test, 2 sided|Paired t-test was used||||26.2|-9.5|0.3369
91736898|NCT02949011|183366972|SUPERIORITY||Median Difference|-0.7||||0.9191||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.9191
91498444|NCT02260921|182867309|SUPERIORITY||Difference in Least Squares (LS) Means|-7.53||||0.0002|TWO_SIDED|95.0|-11.48|-3.58||P-values are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|ANCOVA||LS estimates are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|||-3.58|-11.48|0.0002
91498445|NCT00850564|182867394|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Paired t-test|||Paired t-test comparing baseline and 2 week mean overnight growth hormone||||<0.005
91498446|NCT00850564|182867395|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Paired t-test|||Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.||||0.61
91498447|NCT01804075|182867428|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
91498448|NCT04847557|182867433|SUPERIORITY||Median Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.6|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||10.6|3.3|<0.001
91498449|NCT04847557|182867434|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.026|TWO_SIDED|95.0|0.41|0.95|||Regression, Cox|||Heart Failure Outcomes||0.95|0.41|0.026
91498450|NCT04847557|182867435|SUPERIORITY||Median Difference (Net)|18.3|||<|0.001|TWO_SIDED|95.0|9.9|26.7|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||26.7|9.9|<0.001
91498451|NCT04847557|182867436|SUPERIORITY||LS Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-12.85|-10.38|||ANCOVA|||||-10.38|-12.85|<0.001
91498452|NCT04847557|182867437|SUPERIORITY||LS Mean Difference|-34.91|||<|0.001|TWO_SIDED|95.0|-45.6|-22.17|||ANCOVA|||||-22.17|-45.60|<0.001
91498453|NCT04847557|182867438|SUPERIORITY||Win Ratio|1.63|||||TWO_SIDED|95.0|1.17|2.28|||||The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion.|||2.28|1.17|
91498454|NCT04847557|182867439|SUPERIORITY||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.53|3.4||||||||3.40|1.53|
91498455|NCT04847557|182867440|SUPERIORITY||Hazard Ratio (HR)|1.245|||||TWO_SIDED|95.0|0.633|2.452||||||||2.452|0.633|
91498456|NCT04847557|182867441|SUPERIORITY||Hazard Ratio (HR)|0.539|||||TWO_SIDED|95.0|0.342|0.85||||||||0.850|0.342|
91498457|NCT04847557|182867442|SUPERIORITY||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.46|1.14||||||||1.14|0.46|
91498458|NCT04847557|182867443|SUPERIORITY||Rate Ratio|0.62|||||TWO_SIDED|95.0|0.37|1.05||||||||1.05|0.37|
91498459|NCT01325584|182867445|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||.07
91498460|NCT01325584|182867447|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||.53
91498461|NCT01325584|182867448|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
91498462|NCT02345850|182867470|SUPERIORITY||Hazard Ratio (HR)|0.805||||0.2368|TWO_SIDED|95.0|0.562|1.154||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Tac/MTX Control. The data in primary outcome table provides point estimates at specific time points (1 year and 2 years post randomization). The statistics in this session provides comparisons between different arms for the entire period of the study.||1.154|0.562|0.2368
91498463|NCT02345850|182867470|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.4134|TWO_SIDED|95.0|0.609|1.228||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.228|0.609|0.4134
91498464|NCT02345850|182867470|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.7166|TWO_SIDED|95.0|0.643|1.355||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.355|0.643|0.7166
91498465|NCT02345850|182867470|SUPERIORITY|||||||0.386||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the CRFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||||0.386
91498466|NCT02345850|182867470|SUPERIORITY|||||||0.461||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and disease risk (Low/Intermediate vs. High) for CRFS.||||0.461
91498467|NCT02345850|182867470|SUPERIORITY|||||||0.115||||||Cox proportional hazards regression|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Age (\<=50 vs. \>50) for CRFS.||||0.115
91513587|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-4.2|-0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-4.2|< 0.001
91736899|NCT02949011|183366972|SUPERIORITY||Median Difference|-7.7||||0.0232||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.0232
91736900|NCT02949011|183366972|SUPERIORITY||Median Difference|4.0||||0.5436||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.5436
91736901|NCT02949011|183366972|SUPERIORITY||Median Difference|-7.5||||0.0207||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.0207
91736902|NCT02949011|183366972|SUPERIORITY||Median Difference|-1.9||||0.371||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.3710
91736903|NCT02949011|183366973|SUPERIORITY||Median Difference|-23.4||||0.4634||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.4634
91498468|NCT02345850|182867470|SUPERIORITY|||||||0.227||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Disease (AML vs. ALL vs. MDS) for CRFS.||||0.227
91498469|NCT02345850|182867471|SUPERIORITY||Hazard Ratio (HR)|1.744||||0.0197|TWO_SIDED|95.0|1.086|2.8||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Tac/MTX Control.||2.800|1.086|0.0197
91736904|NCT02949011|183366973|SUPERIORITY||Median Difference|-0.6||||0.6386||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.6386
91736905|NCT02949011|183366974|SUPERIORITY|||||||0.0112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.0112
91736906|NCT02949011|183366974|SUPERIORITY|||||||0.8478||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.8478
91736907|NCT02949011|183366975|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||<0.0001
91736908|NCT02949011|183366975|SUPERIORITY|||||||0.2558||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2558
91736909|NCT00163189|183366977|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Student's paired t-test|||Month 36||||<0.001
91736910|NCT00163189|183366978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Student's paired t-test|||Month 36||||0.008
91736911|NCT01170663|183366996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.807||||0.0169|TWO_SIDED|95.0|0.678|0.962|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.962|0.678|0.0169
91736912|NCT01170663|183366997|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.635|||<|0.0001|TWO_SIDED|95.0|0.536|0.752|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.752|0.536|<0.0001
91736913|NCT01170663|183366998|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.596|||<|0.0001|TWO_SIDED|95.0|0.494|0.72|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.720|0.494|<0.0001
91736914|NCT01170663|183367000|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.0001|TWO_SIDED|95.0|1.45|3.16|||Cochran-Mantel-Haenszel|Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.||||3.16|1.45|0.0001
91736915|NCT01170663|183367008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.|ANCOVA|||||||0.3973
91736916|NCT02261961|183367027|SUPERIORITY||Slope|-0.24275|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736917|NCT02261961|183367028|SUPERIORITY||Slope|1.3707|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736918|NCT02261961|183367031|SUPERIORITY||Slope|-0.35579|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736919|NCT02261961|183367032|SUPERIORITY||Slope|0.004493|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736920|NCT02261961|183367033|SUPERIORITY||Slope|0.870653|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736921|NCT02261961|183367034|SUPERIORITY||Slope|-0.38664|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736922|NCT02261961|183367035|SUPERIORITY||Slope|0.335124|||>|0.05|TWO_SIDED||||||ANCOVA|||Outcomes were compared as percent change from the baseline measure using multiple methods by a blinded statistician. Differences between groups were assessed using ANCOVA, Welch's t-test, and Wilcoxon. No significant differences were found between groups for any outcome regardless of method used.||||>0.05
91736923|NCT02261961|183367037|SUPERIORITY||Slope|0.03145|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736924|NCT02261961|183367038|SUPERIORITY||Slope|-0.43902|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736925|NCT02261961|183367048|SUPERIORITY||Slope|-0.07603|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736926|NCT02261961|183367067|SUPERIORITY||Slope|-0.4745|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
91736927|NCT02431325|183367076|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
91736928|NCT02431325|183367077|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91736929|NCT02431325|183367078|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
91736930|NCT02431325|183367079|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
91736931|NCT02431325|183367080|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91736932|NCT02431325|183367081|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91736933|NCT02431325|183367082|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
91736934|NCT02431325|183367083|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
91498470|NCT02345850|182867471|SUPERIORITY||Hazard Ratio (HR)|1.016||||0.9525|TWO_SIDED|95.0|0.599|1.724||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control.||1.724|0.599|0.9525
91498471|NCT02345850|182867471|SUPERIORITY||Hazard Ratio (HR)|1.774||||0.0185|TWO_SIDED|95.0|1.093|2.877||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide.||2.877|1.093|0.0185
91498472|NCT02345850|182867471|SUPERIORITY|||||||0.026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the OS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.026
91498473|NCT02345850|182867472|SUPERIORITY|||||||0.029||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Relapse-Free Survival between the treatment groups.||||0.029
91736935|NCT02431325|183367084|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91736936|NCT02431325|183367085|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91736937|NCT02431325|183367086|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91736938|NCT02431325|183367087|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91736939|NCT02431325|183367088|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
91736940|NCT02431325|183367089|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
91736941|NCT02431325|183367090|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91736942|NCT02431325|183367091|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
91736943|NCT02431325|183367092|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
91736944|NCT02431325|183367093|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 24||||0.09
91736945|NCT02431325|183367093|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 12||||0.25
91736946|NCT02431325|183367094|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
91736947|NCT02431325|183367095|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91736948|NCT01008618|183367104|SUPERIORITY_OR_OTHER|||||||0.0846|||||||Log Rank|||||||0.0846
91736949|NCT01128569|183367121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||||TWO_SIDED|95.0|0.087|0.237||||||||0.237|0.087|
91736950|NCT01128569|183367121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0|0.069|0.222||||||||0.222|0.069|
91736951|NCT01128569|183367121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-0.091|0.057||||||||0.057|-0.091|
91736952|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.21||||0.92|TWO_SIDED|95.0|-4.48|4.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for FACT-B 3 month Total Score||4.05|-4.48|0.92
91736953|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|1.37||||0.57|TWO_SIDED|95.0|-3.41|6.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for FACT-B 6 month Total Score||6.15|-3.41|0.57
91736954|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|1.18||||0.62|TWO_SIDED|95.0|-3.54|5.89|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the Fact-B 12 month Total Score||5.89|-3.54|0.62
91736955|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|0.12||||0.83|TWO_SIDED|95.0|-0.99|1.23|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Physical Well-Being Subscale||1.23|-0.99|0.83
91736956|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.15||||0.82|TWO_SIDED|95.0|-1.15|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 6 month Physical Well-Being Subscale||1.45|-1.15|0.82
91736957|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.84|TWO_SIDED|95.0|-1.41|1.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 12 month Physical Well-Being Subscale||1.15|-1.41|0.84
91760053|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|||||TWO_SIDED|95.0|-1.19|-0.46||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.46|-1.19|
91736958|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.77|TWO_SIDED|95.0|-1.31|0.96|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Social/Family Well-Being Subscale||0.96|-1.31|0.77
91736959|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.56||||0.42|TWO_SIDED|95.0|-1.91|0.79|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Social/Family Well-Being Subscale||0.79|-1.91|0.42
91736960|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.08||||0.9|TWO_SIDED|95.0|-1.41|1.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Social/Family Well-Being Subscale||1.24|-1.41|0.90
91736961|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.9|TWO_SIDED|95.0|-0.76|0.87|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Emotional Well-Being Subscale||0.87|-0.76|0.90
91498474|NCT02345850|182867472|SUPERIORITY|||||||0.145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the RFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.145
91498475|NCT02345850|182867473|SUPERIORITY|||||||0.02||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Transplant-Related Mortality between the treatment groups.||||0.020
91498476|NCT02345850|182867473|SUPERIORITY|||||||0.04||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the TRM hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.040
91498477|NCT02345850|182867474|SUPERIORITY|||||||0.2389||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of immunosuppression-free survival at 1-year post-transplant between the treatment groups.||||0.2389
91498478|NCT02345850|182867474|SUPERIORITY||||||<|0.0001|||||||Cohen's Kappa|||The null hypothesis is that there is no agreement between CRFS and immunosuppression-free survival at 1-year post-transplant.||||<0.0001
91498479|NCT02345850|182867475|SUPERIORITY|||||||0.076||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Disease Relapse between the treatment groups.||||0.076
91498480|NCT02345850|182867475|SUPERIORITY|||||||0.106||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the Disease Relapse hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.106
91498481|NCT02345850|182867476|SUPERIORITY|||||||0.0764||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Engraftment post-transplantation between the treatment groups.||||0.0764
91530917|NCT00518713|182937849|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
91736962|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.58||||0.25|TWO_SIDED|95.0|-0.4|1.56|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact B 6 month Emotional Well-Being Subscale||1.56|-0.40|0.25
91736963|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.22|TWO_SIDED|95.0|-0.36|1.57|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Emotional Well-Being Subscale||1.57|-0.36|0.22
91736964|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.14||||0.81|TWO_SIDED|95.0|-1.05|1.34|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 3 month Functional Well-Being Subscale||1.34|-1.05|0.81
91736965|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.54||||0.45|TWO_SIDED|95.0|-0.85|1.94|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 6 month Functional Well-Being Subscale||1.94|-0.85|0.45
91498482|NCT02345850|182867477|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet recovery post-transplantation between the treatment groups.||||0.0001
91498483|NCT02345850|182867479|SUPERIORITY|||||||0.1478|||||||Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Secondary graft failure post-transplantation between the treatment groups.||||0.1478
91498484|NCT02345850|182867480|SUPERIORITY|||||||0.0026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.0026
91498485|NCT02345850|182867480|SUPERIORITY|||||||0.0369||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups.||||0.0369
91498486|NCT02345850|182867480|SUPERIORITY|||||||0.002||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade II-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.002
91498487|NCT02345850|182867480|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade III-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.046
91498488|NCT02345850|182867482|SUPERIORITY|||||||0.0024||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups.||||0.0024
91498489|NCT02345850|182867482|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.005
91498490|NCT02345850|182867483|SUPERIORITY|||||||0.229||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Chronic GVHD-free Survival post-transplantation between the treatment groups.||||0.229
91498491|NCT02345850|182867485|SUPERIORITY|||||||0.0006||||||Superiority - Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades II-III infection post-transplantation between the treatment groups.||||0.0006
91498492|NCT02345850|182867485|SUPERIORITY|||||||0.0145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades III infection post-transplantation between the treatment groups.||||0.0145
91498493|NCT02392247|182867491|SUPERIORITY_OR_OTHER||Slope|0.34|||<|0.001|TWO_SIDED|95.0|0.26|0.44||This study was not designed to determine which method is 'superior'.Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming Regression||Slope measured deviation from 1:1 concordance between SEER and TEG with TEG measurement as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)||0.44|0.26|<0.001
91498494|NCT02392247|182867492|SUPERIORITY_OR_OTHER||Slope|3.1|||<|0.001|TWO_SIDED|95.0|2.9|3.4||This study was not designed to determine which method is 'superior'. Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming regression|Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )||3.4|2.9|<0.001
91498495|NCT02801942|182867515|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|3.307|||TWO_SIDED|95.0|-4.59|9.21|||||The mean difference in circulating B lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||9.21|-4.59|
91498496|NCT02801942|182867515|OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|2.398|||TWO_SIDED|95.0|-1.46|8.54|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||8.54|-1.46|
91498497|NCT02801942|182867515|OTHER||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.854|||TWO_SIDED|95.0|-6.87|0.86|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||0.86|-6.87|
91498498|NCT02801942|182867515|OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|4.482||||95.0|-11.86|6.84|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||6.84|-11.86|
91498499|NCT02801942|182867516|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|2.658|||TWO_SIDED|95.0|-2.22|8.98|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.98|-2.22|
91498500|NCT02801942|182867516|OTHER||Mean Difference (Final Values)|8.59|STANDARD_ERROR_OF_MEAN|5.833|||TWO_SIDED|95.0|-3.72|20.91|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||20.91|-3.72|
91530918|NCT01644474|182937875|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-40.2|-23.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-23.0|-40.2|<0.0001
91498501|NCT02801942|182867516|OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-6.53|3.38|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.38|-6.53|
91498502|NCT02801942|182867516|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|5.221|||TWO_SIDED|95.0|-19.32|2.71|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.71|-19.32|
91498503|NCT02801942|182867517|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.9|2.75|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.75|-0.90|
91498504|NCT02801942|182867517|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.07|0.19|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.19|-0.07|
91530919|NCT01644474|182937876|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-21.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-21.2|-35.7|<0.0001
91530920|NCT01644474|182937877|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.3|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.3|<0.0001
91736966|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.11||||0.87|TWO_SIDED|95.0|-1.48|1.26|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Functional Well-Being Subscale||1.26|-1.48|0.87
91498505|NCT02801942|182867517|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-3.41|2.84|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.84|-3.41|
91498506|NCT02801942|182867517|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.1|0.13|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||0.13|-0.10|
91498507|NCT02801942|182867517|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.19|0.31|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.31|-0.19|
91498508|NCT02801942|182867517|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.482|||TWO_SIDED|95.0|-3.23|2.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.96|-3.23|
91530921|NCT01644474|182937878|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|||<|0.0001|TWO_SIDED|95.0|-33.5|-17.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.4|-33.5|<0.0001
91760054|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.85|0.0||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.00|-0.85|
91498509|NCT02801942|182867518|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.231|||TWO_SIDED|95.0|-3.14|6.23|||||The mean difference in B-cells in (Healthy participants versus NOT1D participants) iLN has been presented.|||6.23|-3.14|
91498510|NCT02801942|182867518|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.25|0.34|||||The mean difference in CD56bright sNK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.25|
91498511|NCT02801942|182867518|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.54|0.52|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.52|-0.54|
91498512|NCT02801942|182867518|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.15|0.1|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.10|-0.15|
91530922|NCT01644474|182937879|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-24.7|-12.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.7|-24.7|<0.0001
91530923|NCT01644474|182937880|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.5|-19.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.8|-31.5|<0.0001
91498513|NCT02801942|182867518|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.21|0.34|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.21|
91498514|NCT02801942|182867518|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.487|||TWO_SIDED|95.0|-1.1|0.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-1.10|
91498515|NCT02801942|182867519|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.326|||TWO_SIDED|95.0|-1.73|3.8|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.80|-1.73|
91498516|NCT02801942|182867519|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.324|||TWO_SIDED|95.0|-7.54|2.16|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.16|-7.54|
91760055|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|95.0|-1.15|-0.31||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.31|-1.15|
91736967|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.16||||0.8|TWO_SIDED|95.0|-1.13|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Breast Cancer Subscale||1.45|-1.13|0.80
91736968|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.73||||0.35|TWO_SIDED|95.0|-0.79|2.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Breast Cancer Subscale||2.24|-0.79|0.35
91736969|NCT02941614|183367139|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.42|TWO_SIDED|95.0|-0.88|2.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Breast Cancer Subscale||2.09|-0.88|0.42
91736970|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.03||||0.59|TWO_SIDED|95.0|-0.15|0.09||We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects|Mixed Models Analysis|||Data below is for the BCPT survey 3 month Total Score.||0.09|-0.15|0.59
91736971|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.47|TWO_SIDED|95.0|-0.09|0.19|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Total Score||0.19|-0.09|0.47
91498517|NCT02801942|182867519|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.12|1.95|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||1.95|-1.12|
91498518|NCT02801942|182867520|OTHER||Mean Difference (Final Values)|6.84|STANDARD_ERROR_OF_MEAN|5.564|||TWO_SIDED|95.0|-4.92|18.6|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||18.60|-4.92|
91498519|NCT02801942|182867520|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|7.918|||TWO_SIDED|95.0|-24.77|9.0|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.00|-24.77|
91530924|NCT01644474|182937881|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.4|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.4|<0.0001
91736972|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.37|TWO_SIDED|95.0|-0.2|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Total Score||0.07|-0.20|0.37
91736973|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.05||||0.65|TWO_SIDED|95.0|-0.26|0.17|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Hot Flashes Sub-Scale||0.17|-0.26|0.65
91736974|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.08||||0.54|TWO_SIDED|95.0|-0.17|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Hot Flashes Sub-Scale||0.33|-0.17|0.54
91736975|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.02||||0.87|TWO_SIDED|95.0|-0.27|0.22|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Hot Flashes Sub-Scale||0.22|-0.27|0.87
91736976|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.32|TWO_SIDED|95.0|-0.17|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Nausea Sub-Scale||0.06|-0.17|0.32
91498520|NCT02801942|182867520|OTHER||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-6.66|3.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.73|-6.66|
91498521|NCT02801942|182867521|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|4.558|||TWO_SIDED|95.0|-8.17|10.84|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.84|-8.17|
91498522|NCT02801942|182867521|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|4.658|||TWO_SIDED|95.0|-11.57|7.86|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.86|-11.57|
91704630|NCT02191046|183303955|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Final Values)|4.38|STANDARD_DEVIATION|2.89|<|0.05|TWO_SIDED|95.0|3.41|5.37|||t-test, 2 sided|||compare the mean 5S-score between before and after treatment in syringe group||5.37|3.41|<0.05
91704631|NCT02191046|183303955|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|0.93|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED|95.0|0.094|1.76|||t-test, 2 sided|||compare the mean 5S-score between 2 groups at 2 weeks after treatment||1.76|0.094|<0.05
91704632|NCT02191046|183303955|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.17|<|0.05|TWO_SIDED|95.0|-0.82|-0.12|||t-test, 2 sided|||satisfaction score between two groups at 2 weeks after treatment||-0.12|-0.82|<0.05
91704633|NCT02191046|183303955|NON_INFERIORITY_OR_EQUIVALENCE|power fo study = 90%|Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|3.16|<|0.05|TWO_SIDED|95.0|4.62|6.69|||t-test, 2 sided|||compare the mean 5s-score between before and after treatment in squeezable bottle group||6.69|4.62|<0.05
91704634|NCT02943785|183303977|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.05||||0.0141|TWO_SIDED|95.0|0.85|1.31|||Regression, Cox|||||1.31|0.85|0.0141
91704635|NCT02943785|183303978|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.4||||0.9267|TWO_SIDED|95.0|1.03|1.91|||Regression, Cox|||||1.91|1.03|0.9267
91704636|NCT02603107|183303989|NON_INFERIORITY|A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in Percentages|0.0|||||TWO_SIDED|95.002|-2.5|2.5|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.5|-2.5|
91704637|NCT02603107|183303989|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91704638|NCT02603107|183303990|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|3.2|||||TWO_SIDED|95.002|-1.6|8.2|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||8.2|-1.6|
91736977|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.0||||0.96|TWO_SIDED|95.0|-0.15|0.14|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Nausea Sub-Scale||0.14|-0.15|0.96
91736978|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Nausea Sub-Scale||0.07|-0.21|0.32
91736979|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.44|TWO_SIDED|95.0|-0.24|0.11|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Bladder Control Sub-Scale||0.11|-0.24|0.44
91498523|NCT02801942|182867522|OTHER||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|5.658|||TWO_SIDED|95.0|0.38|24.09|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||24.09|0.38|
91704639|NCT02603107|183303990|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
91704640|NCT02603107|183303991|SUPERIORITY||Difference in Least Squares Means (LSM)|25.0||||0.068|TWO_SIDED|95.0|-2.0|52.0|||ANOVA|||||52|-2|0.068
91704641|NCT01887678|183304020|SUPERIORITY_OR_OTHER||Least Square|-6.37|STANDARD_ERROR_OF_MEAN|3.06||0.0383|TWO_SIDED|95.0|-12.4|-0.35|||ANCOVA||A negative value of the Least Square mean difference indicates a result in favor of Traumeel-Zeel.|||-0.35|-12.40|0.0383
91704642|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Squares|-2.15||||0.3715|TWO_SIDED|95.0|-6.89|2.58|||ANCOVA|||Day 8±1||2.58|-6.89|0.3715
91704643|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Square|-5.87||||0.0293|TWO_SIDED|95.0|-11.15|-0.6|||ANCOVA|||Day 15±1||-0.60|-11.15|0.0293
91704644|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Squares|-5.24||||0.0686|TWO_SIDED|95.0|-10.88|0.4|||ANCOVA|||Day 29±3||0.40|-10.88|0.0686
91704645|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Squares|-7.25||||0.015|TWO_SIDED|95.0|-13.08|-1.42|||ANCOVA|||Day 43±3||-1.42|-13.08|0.0150
91704646|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Squares|-7.56||||0.0134|TWO_SIDED|95.0|-13.54|-1.58|||ANCOVA|||Day 57±3||-1.58|-13.54|0.0134
91498524|NCT02801942|182867522|OTHER||Mean Difference (Final Values)|-10.87|STANDARD_ERROR_OF_MEAN|6.961|||TWO_SIDED|95.0|-25.52|3.78|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.78|-25.52|
91498525|NCT02801942|182867525|OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|6.329|||TWO_SIDED|95.0|-11.41|14.99|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||14.99|-11.41|
91530925|NCT01644474|182937882|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.1|-13.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.5|-23.1|<0.0001
91736980|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.38|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Bladder Control Sub-Scale||0.30|-0.11|0.38
91736981|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.47|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the BCPT survey 12 month Bladder Control Sub-Scale||0.13|-0.28|0.47
91736982|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.13|TWO_SIDED|95.0|-0.39|0.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Vaginal Problems Sub-Scale||0.05|-0.39|0.13
91736983|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.29||||0.03|TWO_SIDED|95.0|-0.55|-0.02|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Vaginal Problems Sub-Scale||-0.02|-0.55|0.03
91736984|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.19||||0.14|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Vaginal Problems Sub-Scale||0.06|-0.45|0.14
91736985|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.53|TWO_SIDED|95.0|-0.14|0.28|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Musculoskeletal Pain Sub-Scale||0.28|-0.14|0.53
91498526|NCT02801942|182867525|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-4.6|4.91|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||4.91|-4.60|
91736986|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.47|TWO_SIDED|95.0|-0.16|0.35|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Musculoskeletal Pain Sub-Scale||0.35|-0.16|0.47
91736987|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.57|TWO_SIDED|95.0|-0.18|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Musculoskeletal Pain Sub-Scale||0.33|-0.18|0.57
91736988|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.21|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Cognitive Problems Sub-Scale||0.21|-0.18|0.85
91498527|NCT02801942|182867525|OTHER||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|3.297|||TWO_SIDED|95.0|-2.5|11.26|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||11.26|-2.50|
91498528|NCT02801942|182867525|OTHER||Mean Difference (Final Values)|-6.06|STANDARD_ERROR_OF_MEAN|5.729|||TWO_SIDED|95.0|-18.01|5.89|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||5.89|-18.01|
91498529|NCT02801942|182867525|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-0.67|0.6|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||0.60|-0.67|
91498530|NCT02801942|182867526|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|3.133|||TWO_SIDED|95.0|-5.33|7.73|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.73|-5.33|
91704647|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Squares|-7.6||||0.0121|TWO_SIDED|95.0|-13.52|-1.68|||Least Squares|||Day 71±3||-1.68|-13.52|0.0121
91704648|NCT01887678|183304021|SUPERIORITY_OR_OTHER||Least Squares|-6.32||||0.0376|TWO_SIDED|95.0|-12.28|-0.37|||ANCOVA|||Day 85±3||-0.37|-12.28|0.0376
91704649|NCT01887678|183304022|SUPERIORITY_OR_OTHER||Least Squares|-4.76||||0.1373|TWO_SIDED|95.0|-11.05|1.53|||ANCOVA|||||1.53|-11.05|0.1373
91704650|NCT01887678|183304023|SUPERIORITY_OR_OTHER||Least Squares|-4.24||||0.1715|TWO_SIDED|95.0|-10.33|1.85|||ANCOVA|||||1.85|-10.33|0.1715
91704651|NCT01887678|183304024|SUPERIORITY_OR_OTHER||Least Squares|-4.77||||0.1211|TWO_SIDED|95.0|-10.82|1.27|||ANCOVA|||||1.27|-10.82|0.1211
91704652|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-4.97||||0.1128|TWO_SIDED|95.0|-11.12|1.18|||ANCOVA|||Day 8±1||1.18|-11.12|0.1128
91704653|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-10.49||||0.0013|TWO_SIDED|95.0|-16.85|-4.13|||ANCOVA|||Day 15±1||-4.13|-16.85|0.0013
91704654|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-6.89||||0.0472|TWO_SIDED|95.0|-13.69|-0.09|||ANCOVA|||Day 29±3||-0.09|-13.69|0.0472
91704655|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-8.82||||0.0109|TWO_SIDED|95.0|-15.6|-2.05|||ANCOVA|||Day 43±3||-2.05|-15.60|0.0109
91704656|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-8.88||||0.0123|TWO_SIDED|95.0|-15.8|-1.95|||ANCOVA|||Day 57±3||-1.95|-15.80|0.0123
91704657|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-6.88||||0.0425|TWO_SIDED|95.0|-13.52|-0.23|||ANCOVA|||Day 71±3||-0.23|-13.52|0.0425
91704658|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-5.51||||0.1199|TWO_SIDED|95.0|-12.47|1.45|||ANCOVA|||Day 85±3||1.45|-12.47|0.1199
91704659|NCT01887678|183304029|SUPERIORITY_OR_OTHER||Least Squares|-4.96||||0.1575|TWO_SIDED|95.0|-11.86|1.93|||ANCOVA|||Day 119±3||1.93|-11.86|0.1575
91704660|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6346|TWO_SIDED|95.0|-1.45|0.89|||ANCOVA|||Day 8±1||0.89|-1.45|0.6346
91704661|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6458|TWO_SIDED|95.0|-1.49|0.92|||ANCOVA|||Day 15±1||0.92|-1.49|0.6458
91704662|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.18||||0.7581|TWO_SIDED|95.0|-1.35|0.99|||ANCOVA|||Day 29±3||0.99|-1.35|0.7581
91704663|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.49||||0.335|TWO_SIDED|95.0|-1.48|0.51|||ANCOVA|||Day 43±3||0.51|-1.48|0.3350
91704664|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.4||||0.4419|TWO_SIDED|95.0|-1.44|0.63|||ANCOVA|||Day 57±3||0.63|-1.44|0.4419
91704665|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.37||||0.446|TWO_SIDED|95.0|-1.32|0.58|||ANCOVA|||Day 71±3||0.58|-1.32|0.4460
91704666|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|0.25||||0.6552|TWO_SIDED|95.0|-0.84|1.33|||ANCOVA|||Day 85±3||1.33|-0.84|0.6552
91704667|NCT01887678|183304030|SUPERIORITY_OR_OTHER||Least Squares|-0.19||||0.7443|TWO_SIDED|95.0|-1.33|0.95|||ANCOVA|||Day 119±3||0.95|-1.33|0.7443
91704668|NCT01887678|183304035|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After first injection of study drug||||0.2164
91704669|NCT01887678|183304035|SUPERIORITY_OR_OTHER|||||||0.1651|TWO_SIDED|||||Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions|Log Rank|||After second injection of study drug||||0.1651
91704670|NCT01887678|183304035|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After third injection of study drug||||0.2220
91704671|NCT01887678|183304036|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||Log Rank|For equality of survival functions||After first injection of study drug||||0.0264
91704672|NCT01887678|183304036|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED||||||Log Rank|For equality of survival functions||After second injection of study drug||||0.0346
91736989|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.38|TWO_SIDED|95.0|-0.12|0.32|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Cognitive Problems Sub-Scale||0.32|-0.12|0.38
91736990|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.23|TWO_SIDED|95.0|-0.35|0.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Cognitive Problems Sub-Scale||0.09|-0.35|0.23
91736991|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.14||||0.18|TWO_SIDED|95.0|-0.35|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Weight Problems Sub-Scale||0.07|-0.35|0.18
91736992|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.35|TWO_SIDED|95.0|-0.36|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Weight Problems Sub-Scale||0.13|-0.36|0.35
91736993|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.34|TWO_SIDED|95.0|-0.36|0.12|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Weight Problems Sub-Scale||0.12|-0.36|0.34
91736994|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.22|TWO_SIDED|95.0|-0.06|0.25|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Arm Problems Sub-Scale||0.25|-0.06|0.22
91498531|NCT02801942|182867526|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-3.73|2.41|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.41|-3.73|
91498532|NCT02801942|182867526|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-7.67|3.96|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.96|-7.67|
91498533|NCT02801942|182867526|OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|6.342|||TWO_SIDED|95.0|-12.54|13.87|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||13.87|-12.54|
91736995|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.11||||0.26|TWO_SIDED|95.0|-0.08|0.29|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Arm Problems Sub-Scale||0.29|-0.08|0.26
91498534|NCT02801942|182867526|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-1.71|0.36|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.36|-1.71|
91498535|NCT02801942|182867529|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|95.0|-0.84|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.16|-0.84|
91498536|NCT02801942|182867530|OTHER||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-15.37|2.96|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.96|-15.37|
91498537|NCT02801942|182867531|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.269|||TWO_SIDED|95.0|-1.61|3.68|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.68|-1.61|
91736996|NCT02941614|183367140|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.34|TWO_SIDED|95.0|-0.09|0.27|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Arm Problems Sub-Scale||0.27|-0.09|0.34
91736997|NCT02941614|183367141|OTHER||Rate Ratio|0.86||||0.006|TWO_SIDED|95.0|0.77|0.96|||Regression, Poisson|||||0.96|0.77|0.006
91736998|NCT02941614|183367142|OTHER||Rate Ratio|1.07||||0.356|TWO_SIDED|95.0|0.93|1.07|||Regression, Poisson|||||1.07|0.93|0.356
91736999|NCT02941614|183367143|OTHER||Rate Ratio|1.02||||0.919|TWO_SIDED|95.0|0.73|1.41|||Regression/Poisson|||||1.41|0.73|0.919
91737000|NCT02941614|183367144|OTHER||Rate Ratio|1.16||||0.367|TWO_SIDED|95.0|0.84|1.62|||Regression, Poisson|||The data below applies to Emergency Department visits||1.62|0.84|0.367
91737001|NCT02941614|183367144|OTHER||Rate Ratio|0.84||||0.497|TWO_SIDED|95.0|0.51|1.38|||Regression, Poisson|||The data below applies to Urgent Care visits||1.38|0.51|0.497
91737002|NCT01469039|183367158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91737003|NCT01469039|183367158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91737004|NCT01469039|183367159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
91498538|NCT02801942|182867531|OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|3.152|||TWO_SIDED|95.0|-8.12|5.03|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.03|-8.12|
91498539|NCT02801942|182867531|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.089|||TWO_SIDED|95.0|-4.59|4.13|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.13|-4.59|
91498540|NCT02801942|182867531|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|3.835|||TWO_SIDED|95.0|-7.08|8.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.92|-7.08|
91498541|NCT02801942|182867531|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|-0.4|0.21|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.21|-0.40|
91498542|NCT02801942|182867532|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.236||||95.0|-0.23|0.75|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.75|-0.23|
91498543|NCT02801942|182867532|OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|3.943|||TWO_SIDED|95.0|-10.2|6.29|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.29|-10.20|
91498544|NCT02801942|182867532|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.621|||TWO_SIDED|95.0|-5.38|9.69|||||The mean difference in Effector Memory Conv T cells(Healthy participants versus NOT1D participants) in iLN has been presented.|||9.69|-5.38|
91498545|NCT02801942|182867532|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.629|||TWO_SIDED|95.0|-10.47|8.86|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.86|-10.47|
91498546|NCT02801942|182867532|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|-0.77|0.34|||||The mean difference in Stem cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.77|
91704673|NCT01887678|183304036|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED||||||Log Rank|For equality of survival functions||After third injection of study drug||||0.0172
91704674|NCT01432561|183304081|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.04
91704675|NCT01432561|183304081|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||High-protein compared to fasted condition||||.005
91704676|NCT01432561|183304082|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.16
91704677|NCT01432561|183304082|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|||High-protein compared to fasted condition||||.036
91704678|NCT01432561|183304083|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Non-parametric Hodges-Lehmann method|||Fed high-fat/calorie compared to fasted condition.||||.30
91704679|NCT01432561|183304083|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Non-parametric Hodges-Lehmann method|||High-protein compared to fasted condition||||.05
91704680|NCT02638259|183304090|EQUIVALENCE|A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|-0.26|0.12||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.12|-0.26|
91704681|NCT02952872|183304135|SUPERIORITY||||||<|0.05|||||||ANOVA|Mixed Design ANOVA||||||<.05
91704682|NCT02952872|183304136|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91704683|NCT02952872|183304137|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91704684|NCT02952872|183304138|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91704685|NCT01260584|183304139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|4.11||0.0624|TWO_SIDED|95.0|-0.4|15.8|||Mixed Models Analysis|||For the sample size calculations for the co-primary endpoints, no Type 1 error rate was adjusted and both co-primary endpoints will be tested at the 0.05 level.||15.8|-0.4|0.0624
91704686|NCT01260584|183304139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|25.1|38.4|||Mixed Models Analysis|||||38.4|25.1|<0.0001
91704687|NCT01260584|183304139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.08||0.244|TWO_SIDED|95.0|-3.3|12.8|||Mixed Models Analysis|||||12.8|-3.3|0.2440
91704688|NCT01260584|183304139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|28.4|41.0|||Mixed Models Analysis|||||41.0|28.4|<0.0001
91704689|NCT01260584|183304139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.0|STANDARD_ERROR_OF_MEAN|4.14|<|0.0001|TWO_SIDED|95.0|18.8|35.2|||Mixed Models Analysis|||||35.2|18.8|<0.0001
91704690|NCT01260584|183304140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.2|STANDARD_ERROR_OF_MEAN|12.65||0.0048|TWO_SIDED|95.0|-61.1|-11.2|||Mixed Models Analysis|||||-11.2|-61.1|0.0048
91704691|NCT01260584|183304140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.8|STANDARD_ERROR_OF_MEAN|11.54|<|0.0001|TWO_SIDED|95.0|-116.7|-71.0|||Mixed Models Analysis|||||-71.0|-116.7|<0.0001
91704692|NCT01260584|183304140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|STANDARD_ERROR_OF_MEAN|12.53||0.0924|TWO_SIDED|95.0|-45.9|3.5|||Mixed Models Analysis|||||3.5|-45.9|0.0924
91704693|NCT01260584|183304140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.8|STANDARD_ERROR_OF_MEAN|10.85|<|0.0001|TWO_SIDED|95.0|-130.3|-87.3|||Mixed Models Analysis|||||-87.3|-130.3|<0.0001
91704694|NCT01260584|183304140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.6|STANDARD_ERROR_OF_MEAN|12.73|<|0.0001|TWO_SIDED|95.0|-97.8|-47.5|||Mixed Models Analysis|||||-47.5|-97.8|<0.0001
91704695|NCT01260584|183304141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.72||0.0423|TWO_SIDED|95.0|-15.0|-0.3|||Mixed Models Analysis|||||-0.3|-15.0|0.0423
91737005|NCT01469039|183367159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
91737006|NCT02013609|183367175|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in MADRS total score at Week 12 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
91737007|NCT02013609|183367176|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
91737008|NCT02013609|183367181|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction.||Statistical analysis at Week 12.||||<0.0001
91737009|NCT02013609|183367182|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
91737010|NCT02013609|183367183|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities||||<0.0001
91737011|NCT02013609|183367184|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
91737012|NCT02013609|183367185|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
91737013|NCT02013609|183367186|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
91737014|NCT02013609|183367187|SUPERIORITY_OR_OTHER|||||||0.3439|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (Go cues)||||0.3439
91737015|NCT02013609|183367187|SUPERIORITY_OR_OTHER|||||||0.3385|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)||||0.3385
91737016|NCT02013609|183367188|SUPERIORITY_OR_OTHER|||||||0.2052|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (Go cues)||||0.2052
91737017|NCT02013609|183367188|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (No-Go cues)||||0.3224
91737018|NCT02013609|183367189|SUPERIORITY_OR_OTHER|||||||0.3169|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12||||0.3169
91737019|NCT02013609|183367190|SUPERIORITY_OR_OTHER|||||||0.3352|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12||||0.3352
91737020|NCT02013609|183367191|SUPERIORITY_OR_OTHER|||||||0.3517|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task k value||||0.3517
91737021|NCT02013609|183367191|SUPERIORITY_OR_OTHER|||||||0.3799|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task h value||||0.3799
91737022|NCT02013609|183367192|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for food)||||0.2610
91737023|NCT02013609|183367192|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
91737024|NCT02013609|183367193|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
91737025|NCT02013609|183367194|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
91737026|NCT01816295|183367195|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91498547|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|2.556|||TWO_SIDED|95.0|-10.42|0.25|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.25|-10.42|
91498548|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.15|0.07|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.07|-0.15|
91498549|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.08|2.88|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.88|-3.08|
91498550|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|4.294|||TWO_SIDED|95.0|-6.87|11.05|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||11.05|-6.87|
91498551|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-4.94|5.0|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.00|-4.94|
91498552|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.112|||TWO_SIDED|95.0|-2.31|2.32|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.32|-2.31|
91498553|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|95.0|-2.73|1.55|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.55|-2.73|
91498554|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|1.474|||TWO_SIDED|95.0|-1.51|4.64|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.64|-1.51|
91498555|NCT02801942|182867533|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.504|||TWO_SIDED|95.0|-1.05|1.05|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-1.05|
91498556|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|3.607|||TWO_SIDED|95.0|-5.99|9.07|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.07|-5.99|
91498557|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.855|||TWO_SIDED|95.0|-2.43|1.18|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.18|-2.43|
91498558|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.391|||TWO_SIDED|95.0|-2.49|3.31|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.31|-2.49|
91498559|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.824|||TWO_SIDED|95.0|-9.39|2.39|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.39|-9.39|
91498560|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.29|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.78|-1.29|
91498561|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.544|||TWO_SIDED|95.0|-0.73|1.54|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.54|-0.73|
91498562|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.246|||TWO_SIDED|95.0|-2.12|3.07|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.07|-2.12|
91498563|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|2.641|||TWO_SIDED|95.0|-2.45|8.55|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.55|-2.45|
91704696|NCT01260584|183304141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-29.0|-16.4|||Mixed Models Analysis|||||-16.4|-29.0|<0.0001
91704697|NCT01260584|183304141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.7||0.1184|TWO_SIDED|95.0|-13.1|1.5|||Mixed Models Analysis|||||1.5|-13.1|0.1184
91704698|NCT01260584|183304141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|3.02|<|0.0001|TWO_SIDED|95.0|-30.5|-18.5|||Mixed Models Analysis|||||-18.5|-30.5|<0.0001
91704699|NCT01260584|183304141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-24.3|-9.5|||Mixed Models Analysis|||||-9.5|-24.3|<0.0001
91704700|NCT01260584|183304142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.1331|TWO_SIDED|95.0|0.8|5.32|||Regression, Logistic|||||5.32|0.80|0.1331
91704701|NCT01260584|183304142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.5813|TWO_SIDED|95.0|0.17|23.65|||Regression, Logistic|||||23.65|0.17|0.5813
91704702|NCT01260584|183304142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.54||||0.0127|TWO_SIDED|95.0|1.85|148.23|||Regression, Logistic|||||148.23|1.85|0.0127
91704703|NCT01260584|183304142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.11||||0.0013|TWO_SIDED|95.0|3.13|93.65|||Regression, Logistic|||||93.65|3.13|0.0013
91704704|NCT01260584|183304143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5684|TWO_SIDED|95.0|0.49|3.67|||Regression, Logistic|||||3.67|0.49|0.5684
91704705|NCT01260584|183304143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7||||0.0447|TWO_SIDED|95.0|1.05|42.92|||Regression, Logistic|||||42.92|1.05|0.0447
91704706|NCT01260584|183304143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.64||||0.0003|TWO_SIDED|95.0|6.8|505.58|||Regression, Logistic|||||505.58|6.80|0.0003
91704707|NCT01260584|183304143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.0006|TWO_SIDED|95.0|2.95|46.52|||Regression, Logistic|||||46.52|2.95|0.0006
91498564|NCT02801942|182867534|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|95.0|-0.92|0.96|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-0.92|
91498565|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|-4.83|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.71|1.05|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-10.71|
91498566|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.953|||TWO_SIDED|95.0|-2.82|1.16|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.16|-2.82|
91498567|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|-2.88|STANDARD_ERROR_OF_MEAN|1.536||||95.0|-6.08|0.33|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.33|-6.08|
91498568|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|0.963|||TWO_SIDED|95.0|-0.2|3.81|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.81|-0.20|
91737027|NCT01816295|183367196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|99.5|1.05|9.07|||ANCOVA|||||9.07|1.05|<0.001
91737028|NCT01816295|183367197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|1.25||0.019|TWO_SIDED|99.5|-0.59|6.45|||ANCOVA|||||6.45|-0.59|0.019
91737029|NCT01816295|183367198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.442|TWO_SIDED|95.0|-0.94|0.41|||ANCOVA|||Change from Baseline to Week 12||0.41|-0.94|0.442
91737030|NCT01816295|183367198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.905|TWO_SIDED|95.0|-0.82|0.72|||ANCOVA|||Change from Baseline to Week 36||0.72|-0.82|0.905
91498569|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.289|||TWO_SIDED|95.0|-2.99|2.39|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.39|-2.99|
91737031|NCT04067011|183367234|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9764|||||TWO_SIDED|90.0|0.8895|1.0718||||||Analysis of Geometric mean ratio of area under the curve from 0 to 12 hours (AUC0-12h) for ciprofloxacin on Days 8 and 35||1.0718|0.8895|
91737032|NCT04067011|183367234|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.9706|||||TWO_SIDED|90.0|0.8693|1.0838||||||Analysis of Geometric mean ration of Cmax for ciprofloxacin on Days 8 and 35||1.0838|0.8693|
91498570|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.907|||TWO_SIDED|95.0|-0.59|7.36|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.36|-0.59|
91498571|NCT02801942|182867535|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.413|||TWO_SIDED|95.0|-4.11|1.78|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.78|-4.11|
91498572|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.918|||TWO_SIDED|95.0|-5.6|6.63|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-5.60|
91498573|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.842|||TWO_SIDED|95.0|-7.93|-0.26|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||-0.26|-7.93|
91498574|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|1.209|||TWO_SIDED|95.0|-4.34|1.24|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.24|-4.34|
91498575|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.725|||TWO_SIDED|95.0|-4.51|2.77|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.77|-4.51|
91498576|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.193|||TWO_SIDED|95.0|-5.02|4.09|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.09|-5.02|
91737033|NCT04067011|183367235|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9173|||||TWO_SIDED|90.0|0.8187|1.0278||||||Analysis of Geometric mean ratio of Area under the curve from 0 to 12 hours (AUC0-12h) for doxycycline on Days 8 and 38||1.0278|0.8187|
91737034|NCT04067011|183367235|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.8974|||||TWO_SIDED|90.0|0.7841|1.0271||||||Analysis of Geometric mean ration of Cmax for doxycycline on Days 8 and 38||1.0271|0.7841|
91737035|NCT04067011|183367236|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 1/Group 3)|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
91737036|NCT04067011|183367236|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 2/Group 3)|1.14|||||TWO_SIDED|95.0|0.81|1.6||||||||1.6|0.81|
91737037|NCT05209386|183367237|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 17 channels and time windows where neural responses differed according to change in F0.|||
91737038|NCT05209386|183367238|OTHER||||||<|0.0001|||||||t-test, 2 sided|t(20.45) = -5.8||||||<0.0001
91498577|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|3.405|||TWO_SIDED|95.0|-6.52|7.68|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.68|-6.52|
91498578|NCT02801942|182867536|OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.811|||TWO_SIDED|95.0|-2.21|1.4|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.40|-2.21|
91737039|NCT05209386|183367239|OTHER||||||<|0.0001|||||||Mixed Models Analysis|For interaction term (effect of interest): t(1016) = -2.7|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||<0.0001
91737040|NCT05209386|183367240|OTHER||||||<|0.0001|||||||Mixed Models Analysis|t(48) = -4.50||The null hypothesis is that there is no effect of change in listening context on behavioral responses of participants.||||<0.0001
91737041|NCT05209386|183367241|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels in non-regions of interest that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 4 channels and time windows where neural responses differed according to change in F0.|||
91737042|NCT05209386|183367242|OTHER|||||||0.48|||||||Mixed Models Analysis|For interaction term (effect of interest): t(216) = -0.707|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||0.480
91737043|NCT04436744|183367243|SUPERIORITY|||||||0.0433|||||||t-test, 2 sided|||||||0.0433
91737044|NCT04436744|183367244|SUPERIORITY||Difference in Overall Response Rates|-0.93||||0.8272|TWO_SIDED|95.0|-14.66|12.81|||Cochran-Mantel-Haenszel|||ORR was calculated using the stratified Cochran-Mantel-Haenszel test.||12.81|-14.66|0.8272
91737045|NCT04436744|183367245|SUPERIORITY||Difference in Rate|6.86|||||TWO_SIDED|95.0|-4.25|17.97||||||||17.97|-4.25|
91498579|NCT02801942|182867537|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.86|1.65|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.65|-0.86|
91737046|NCT01240863|183367259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.82||statistical significance level of 0.05.|ANCOVA|Treatment and stratification (opioid naïve/opioid experienced) factors as the fixed effects; screening and baseline APIs as covariates.|placebo - hydrocodone|||0.82|-0.11|0.134
91737047|NCT01538199|183367287|SUPERIORITY_OR_OTHER|||||||0.04||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|We used a modified intent-to-treat approach with LOCF and unpaired Student's t-test (one-way), comparing the change in total severity score.||||||0.04
91737048|NCT01538199|183367287|SUPERIORITY_OR_OTHER|||||||0.08||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.||||||0.08
91737049|NCT01538199|183367287|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.01
91498580|NCT02801942|182867538|OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.929|||TWO_SIDED|95.0|-2.18|1.7|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.70|-2.18|
91498581|NCT02801942|182867539|OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|95.0|0.02|1.87|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.87|0.02|
91737050|NCT01538199|183367287|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.02
91737051|NCT01538199|183367287|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.||||0.004
91737052|NCT01538199|183367290|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.||||||0.18
91737053|NCT01538199|183367290|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to measure the change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.01
91498582|NCT02801942|182867539|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.04|0.38|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.38|-2.04|
91498583|NCT02801942|182867540|OTHER||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.81|6.27|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.27|-11.81|
91498584|NCT02801942|182867540|OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-0.04|4.44|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.44|-0.04|
91498585|NCT02801942|182867541|OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.214|||TWO_SIDED|95.0|-5.91|3.32|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.32|-5.91|
91498586|NCT02801942|182867541|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.28|1.57|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.28|
91498587|NCT02801942|182867541|OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|3.017|||TWO_SIDED|95.0|-2.08|10.51|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.51|-2.08|
91498588|NCT02801942|182867541|OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-3.03|1.08|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.08|-3.03|
91498589|NCT02801942|182867541|OTHER||Mean Difference (Final Values)|-4.86|STANDARD_ERROR_OF_MEAN|3.802|||TWO_SIDED|95.0|-12.8|3.07|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.07|-12.80|
91498590|NCT02801942|182867541|OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.733|||TWO_SIDED|95.0|-1.27|18.47|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||18.47|-1.27|
91498591|NCT02801942|182867542|OTHER||Mean Difference (Final Values)|6.53|STANDARD_ERROR_OF_MEAN|4.905||||95.0|-3.78|16.85|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||16.85|-3.78|
91498592|NCT02801942|182867542|OTHER||Mean Difference (Final Values)|-8.54|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-18.17|1.1|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.10|-18.17|
91498593|NCT02801942|182867542|OTHER||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|2.519|||TWO_SIDED|95.0|-3.23|7.45|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.45|-3.23|
91498594|NCT02801942|182867542|OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-0.98|7.59|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.59|-0.98|
91704708|NCT01260584|183304144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|110.7|||||TWO_SIDED|90.0|93.7|130.8|||Mixed Models Analysis|||Prasugrel active metabolite R-138727||130.8|93.7|
91498595|NCT02801942|182867542|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.026|||TWO_SIDED|95.0|-8.23|8.67|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.67|-8.23|
91498596|NCT02801942|182867542|OTHER||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-1.32|17.95|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||17.95|-1.32|
91498597|NCT02801942|182867543|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.94|1.57|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|-0.94|
91498598|NCT02801942|182867543|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|0.0|1.28|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.28|0.00|
91498599|NCT02801942|182867543|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|95.0|-0.33|1.11|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.11|-0.33|
91498600|NCT02801942|182867543|OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.78|0.47|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.47|-0.78|
91498601|NCT02801942|182867544|OTHER||Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.989|||TWO_SIDED|95.0|-0.3|3.86|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.86|-0.30|
91498602|NCT02801942|182867544|OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|4.716|||TWO_SIDED|95.0|-12.45|7.35|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.35|-12.45|
91498603|NCT02801942|182867544|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.957|||TWO_SIDED|95.0|-1.86|2.14|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.14|-1.86|
91498604|NCT02801942|182867544|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.9|4.58|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.58|0.90|
91498605|NCT02801942|182867545|OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.344|||TWO_SIDED|95.0|-2.23|3.38|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.38|-2.23|
91498606|NCT02801942|182867545|OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.1|1.57|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.10|
91704709|NCT01260584|183304144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|118.4|||||TWO_SIDED|90.0|99.8|140.4|||Mixed Models Analysis|||active metabolite R-130964||140.4|99.8|
91704710|NCT01260584|183304145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|117.9|||||TWO_SIDED|90.0|94.4|147.3|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Prasugrel active metabolite R-138727||147.3|94.4|
91498607|NCT02801942|182867545|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.594|||TWO_SIDED|95.0|-0.41|2.07|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.07|-0.41|
91530926|NCT01644474|182937883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.8|||<|0.0001|TWO_SIDED|95.0|8.7|139.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||139.0|8.7|<0.0001
91498608|NCT02801942|182867545|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|95.0|-1.54|0.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.92|-1.54|
91498609|NCT02801942|182867546|OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|1.728|||TWO_SIDED|95.0|-0.62|6.63|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-0.62|
91498610|NCT02801942|182867546|OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-11.33|7.21|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.21|-11.33|
91498611|NCT02801942|182867546|OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|2.042|||TWO_SIDED|95.0|-14.56|17.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||17.13|-14.56|
91498612|NCT02801942|182867546|OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.843|||TWO_SIDED|95.0|0.36|3.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.92|0.36|
91498613|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.097|||TWO_SIDED|95.0|-4.24|8.83|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.83|-4.24|
91498614|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|2.334|||TWO_SIDED|95.0|-0.47|9.39|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.39|-0.47|
91498615|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|11.54|STANDARD_ERROR_OF_MEAN|7.693|||TWO_SIDED|95.0|-5.24|28.32|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||28.32|-5.24|
91498616|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|5.64|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-7.73|19.01|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||19.01|-7.73|
91530927|NCT01644474|182937884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|69.8||||0.0001|TWO_SIDED|95.0|8.8|556.0||Threshold for significance was ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||556.0|8.8|0.0001
91498617|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|3.336|||TWO_SIDED|95.0|-8.46|5.71|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.71|-8.46|
91498618|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.755|||TWO_SIDED|95.0|-5.54|1.98|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.98|-5.54|
91498619|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-21.58|4.98|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.98|-21.58|
91498620|NCT02801942|182867547|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|6.019|||TWO_SIDED|95.0|-21.49|4.87|||||The mean difference in Naive B Lymphocytes by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||4.87|-21.49|
91498621|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.538|||TWO_SIDED|95.0|-0.54|10.48|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.48|-0.54|
91498622|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.37|4.61|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.61|-8.37|
91498623|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-0.26|0.54|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.54|-0.26|
91498624|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|95.0|-0.37|0.27|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.27|-0.37|
91498625|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.402|||TWO_SIDED|95.0|-1.27|0.49|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.49|-1.27|
91498626|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.312|||TWO_SIDED|95.0|-0.33|1.07|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.07|-0.33|
91498627|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.16|0.13|||||The mean difference in CD56lo CD16- by (Healthy participants versus NOT1D participants) FNA method has been presented.|||0.13|-0.16|
91498628|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.17|0.12|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.12|-0.17|
91498629|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.03|0.47|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.47|-0.03|
91498630|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.59|0.4|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.40|-0.59|
91498631|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.766|||TWO_SIDED|95.0|-1.72|1.6|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.60|-1.72|
91498632|NCT02801942|182867548|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.417|||TWO_SIDED|95.0|-0.99|0.82|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.82|-0.99|
91498633|NCT02801942|182867549|OTHER||Mean Difference (Final Values)|13.72|STANDARD_ERROR_OF_MEAN|7.475|||TWO_SIDED|95.0|-2.72|30.15|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||30.15|-2.72|
91530928|NCT01644474|182937885|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4||||0.4013|TWO_SIDED|95.0|-14.8|5.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|-14.8|0.4013
91530929|NCT00050089|182937893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.165||||0.69|TWO_SIDED|95.0|0.856|1.585|||Log Rank||The comparison was Mega-ART (intensification) vs Standard-ART (standard).|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.585|0.856|0.69
91737054|NCT01538199|183367290|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test measuring change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.02
91737055|NCT03358030|183367292|OTHER||||||<|0.05|||||||ANOVA|||Day 12 through Day 260||||<0.05
91737056|NCT03358030|183367292|OTHER||||||<|0.05|||||||ANOVA|||Day 15 through Day 232||||<0.05
91737057|NCT03358030|183367293|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 15 through Day 176||||< 0.05
91737058|NCT03358030|183367293|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 12 through Day 176||||< 0.05
91737059|NCT01729039|183367371|SUPERIORITY|||||||0.356||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.356
91737060|NCT01729039|183367371|SUPERIORITY|||||||0.84||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.840
91737061|NCT01729039|183367372|SUPERIORITY|||||||0.17||||||Main effect of Time (baseline to post-PT) Alpha=.05|ANOVA|||||||.170
91498634|NCT02801942|182867549|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|7.566|||TWO_SIDED|95.0|-16.85|16.78|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.78|-16.85|
91737062|NCT01729039|183367372|SUPERIORITY|||||||0.297||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.297
91737063|NCT01729039|183367373|SUPERIORITY||||||<|0.001|||||||ANOVA|Main effect of Time (baseline to post-PT) alpha = .05||||||<.001
91737064|NCT01729039|183367373|SUPERIORITY|||||||0.817||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.817
91737065|NCT01729039|183367374|SUPERIORITY|||||||0.005||||||Main effect of Time (baseline to post-PT) alpha = .05|ANOVA|||||||.005
91737066|NCT01729039|183367374|SUPERIORITY|||||||0.172||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.172
91737067|NCT01729039|183367375|SUPERIORITY|||||||0.009||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.009
91737068|NCT01729039|183367375|SUPERIORITY|||||||0.146||||||Interaction of Time by Grou (GS vs. CON) alpha = .05|ANOVA|||||||.146
91737069|NCT03449576|183367376|SUPERIORITY||Slope|5.3846|STANDARD_ERROR_OF_MEAN|6.5525||0.4154|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the CAPS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4154
91737070|NCT03449576|183367377|SUPERIORITY||Slope|0.267397|STANDARD_ERROR_OF_MEAN|0.362521||0.4636|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the SAS-SR score-- with the interaction between Visit (pre/post) and Treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4636
91737071|NCT03449576|183367378|SUPERIORITY||Slope|2.3355|STANDARD_ERROR_OF_MEAN|6.8791||0.735129|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the PCL score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.735129
91737072|NCT03449576|183367379|SUPERIORITY||Slope|-2.64908|STANDARD_ERROR_OF_MEAN|4.76601||0.58|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the AQ score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.580
91737073|NCT03449576|183367380|SUPERIORITY||Slope|1.3946|STANDARD_ERROR_OF_MEAN|5.7193||0.808|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the ITS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.808
91737074|NCT00404248|183367383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.9|ONE_SIDED||||||t-test, 2 sided|||||||0.9
91737075|NCT00404248|183367384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
91737076|NCT00404248|183367385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.8|TWO_SIDED||||||t-test, 2 sided|||||||0.8
91737077|NCT05788991|183367396|NON_INFERIORITY|Difference of proportions between groups (with 95% CI) and a non inferiority margin of 15 percentage points, assuming a 1-sided α = .025 and 80% power|Farrington-Manning test|-0.5|||<|0.025|ONE_SIDED|95.0|-10.8|||1 sided alpha|Farrington-Manning test|||The outcome measure of the primary objective was a noninferiority margin of 15 percentage points in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment.|||-10.8|<.025
91737078|NCT04464473|183367403|SUPERIORITY|||||||0.5736|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.5736
91737079|NCT04464473|183367403|SUPERIORITY|||||||0.304|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.304
91737080|NCT04464473|183367403|SUPERIORITY|||||||0.0545|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0545
91498635|NCT02801942|182867549|OTHER||Mean Difference (Final Values)|-20.03|STANDARD_ERROR_OF_MEAN|8.586|||TWO_SIDED|95.0|-38.98|-1.08|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||-1.08|-38.98|
91737081|NCT04464473|183367403|SUPERIORITY|||||||0.1134|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.1134
91737082|NCT04464473|183367403|SUPERIORITY|||||||0.4326|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.4326
91498636|NCT02801942|182867549|OTHER||Mean Difference (Final Values)|4.25|STANDARD_ERROR_OF_MEAN|12.739|||TWO_SIDED|95.0|-24.14|32.65|||||The mean difference in CD56lo CD16+ by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||32.65|-24.14|
91737083|NCT04464473|183367403|SUPERIORITY|||||||0.2546|||||||ANOVA|The interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.2546
91737084|NCT04464473|183367403|SUPERIORITY|||||||0.0645|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0645
91737085|NCT04464473|183367403|SUPERIORITY|||||||0.2033|||||||ANOVA|Interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.2033
91737086|NCT04464473|183367404|SUPERIORITY|||||||0.8152|||||||ANOVA|Main effect of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) on overall BOLD actviation.||||||0.8152
91737087|NCT04464473|183367404|SUPERIORITY|||||||0.0085|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.0085
91737088|NCT04464473|183367404|SUPERIORITY|||||||0.1551|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1551
91737089|NCT04464473|183367404|SUPERIORITY|||||||0.6431|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6431
91737090|NCT04464473|183367404|SUPERIORITY|||||||0.2447|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.2447
91498637|NCT02801942|182867549|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|2.429|||TWO_SIDED|95.0|-5.54|5.26|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.26|-5.54|
91737091|NCT04464473|183367404|SUPERIORITY|||||||0.0002|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.0002
91737092|NCT04464473|183367404|SUPERIORITY|||||||0.1339|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem on BOLD activation||||||0.1339
91737093|NCT04464473|183367404|SUPERIORITY|||||||0.1315|||||||ANOVA|Interaction of visit, temporal control, contextual control, and subsystem on BOLD activation||||||0.1315
91737094|NCT04464473|183367404|SUPERIORITY|||||||0.6836|||||||ANOVA|The main effect of intervention arm (FPl-TMS, MFG-TMS, S1-TMS) on overall BOLD activation.||||||0.6836
91737095|NCT04464473|183367404|SUPERIORITY|||||||0.2146|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.2146
91737096|NCT04464473|183367404|SUPERIORITY|||||||0.1541|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1541
91737097|NCT04464473|183367404|SUPERIORITY|||||||0.6657|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6657
91737098|NCT04464473|183367404|SUPERIORITY|||||||0.5619|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.5619
91737099|NCT04464473|183367404|SUPERIORITY|||||||0.5148|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5148
91737100|NCT04464473|183367404|SUPERIORITY|||||||0.5428|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5428
91737101|NCT04464473|183367404|SUPERIORITY|||||||0.1249|||||||ANOVA|Interaction of intervention, temporal control, contextual control, and subsystem on BOLD activation||||||0.1249
91737102|NCT04464473|183367405|SUPERIORITY|||||||0.9504|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.9504
91737103|NCT04464473|183367405|SUPERIORITY|||||||0.7318|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7318
91737104|NCT04464473|183367405|SUPERIORITY|||||||0.8424|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.8424
91737105|NCT04464473|183367405|SUPERIORITY|||||||0.7652|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7652
91737106|NCT04464473|183367406|SUPERIORITY|||||||0.0266|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.0266
91737107|NCT04464473|183367406|SUPERIORITY|||||||0.2386|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.2386
91737108|NCT04464473|183367406|SUPERIORITY|||||||0.4211|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.4211
91498638|NCT02801942|182867549|OTHER||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|4.148|||TWO_SIDED|95.0|-12.31|6.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.73|-12.31|
91737109|NCT04464473|183367406|SUPERIORITY|||||||0.7503|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.7503
91737110|NCT04464473|183367407|SUPERIORITY|||||||0.0091|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.0091
91737111|NCT04464473|183367407|SUPERIORITY|||||||0.0045|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0045
91498639|NCT02801942|182867550|OTHER||Mean Difference (Final Values)|8.25|STANDARD_ERROR_OF_MEAN|7.673|||TWO_SIDED|95.0|-8.58|25.08|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||25.08|-8.58|
91737112|NCT04464473|183367407|SUPERIORITY|||||||0.1082|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.1082
91737113|NCT04464473|183367407|SUPERIORITY|||||||0.0659|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0659
91498640|NCT02801942|182867550|OTHER||Mean Difference (Final Values)|16.22|STANDARD_ERROR_OF_MEAN|6.189|||TWO_SIDED|95.0|3.17|29.26|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||29.26|3.17|
91498641|NCT02801942|182867550|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|95.0|-31.03|15.25|||||The mean difference in Plasmacytoid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||15.25|-31.03|
91498642|NCT02801942|182867550|OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.781|||TWO_SIDED|95.0|-26.04|-1.66|||||The mean difference in (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-1.66|-26.04|
91737114|NCT04464473|183367408|SUPERIORITY|||||||0.0211|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.0211
91737115|NCT04464473|183367408|SUPERIORITY|||||||0.4964|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.4964
91737116|NCT04464473|183367408|SUPERIORITY|||||||0.3129|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.3129
91737117|NCT04464473|183367408|SUPERIORITY|||||||0.5439|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.5439
91737118|NCT04464473|183367409|SUPERIORITY|||||||0.0344|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0344
91498643|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|3.561|||TWO_SIDED|95.0|-9.05|5.82|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.82|-9.05|
91498644|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.418|||TWO_SIDED|95.0|-3.13|11.16|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||11.16|-3.13|
91498645|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.14|2.82|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.82|-3.14|
91737119|NCT04464473|183367409|SUPERIORITY|||||||0.5113|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.5113
91737120|NCT04464473|183367409|SUPERIORITY|||||||0.0301|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0301
91737121|NCT04464473|183367409|SUPERIORITY|||||||0.6931|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.6931
91737122|NCT04464473|183367410|SUPERIORITY|||||||0.0189|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.0189
91498646|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.851|||TWO_SIDED|95.0|-5.03|2.71|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.71|-5.03|
91737123|NCT04464473|183367410|SUPERIORITY|||||||0.0763|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.0763
91737124|NCT04464473|183367410|SUPERIORITY|||||||0.9701|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.9701
91737125|NCT04464473|183367410|SUPERIORITY|||||||0.3826|||||||ANOVA|Interaction of intervention(MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.3826
91737126|NCT03802396|183367411|OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
91737127|NCT03802396|183367412|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.116
91737128|NCT03802396|183367412|OTHER|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.388
91737129|NCT03802396|183367413|OTHER|||||||0.569|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.569
91737130|NCT03802396|183367413|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.047
91737131|NCT03802396|183367414|OTHER|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.498
91737132|NCT03802396|183367414|OTHER|||||||0.745|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.745
91737133|NCT03802396|183367415|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.177
91737134|NCT03802396|183367415|OTHER|||||||0.478|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.478
91737135|NCT03802396|183367416|OTHER|||||||0.803|||||||t-test, 2 sided|||||||0.803
91737136|NCT03802396|183367418|OTHER||Risk Ratio (RR)|0.73||||0.286|TWO_SIDED|95.0|0.41|1.3|||Chi-squared|||||1.30|0.41|0.286
91737137|NCT03802396|183367419|OTHER|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
91498647|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|3.132|||TWO_SIDED|95.0|-8.65|4.43|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.43|-8.65|
91737138|NCT04066829|183367422|OTHER||Difference in Differences|-29.2|||||TWO_SIDED|95.0|-42.2|-11.8||||||Pre and post difference in the treatment group as compared to the control group. A log transformation was used.||-11.8|-42.2|
91737139|NCT00163293|183367445|SUPERIORITY_OR_OTHER|||||||0.6625||95.0|||||Log Rank|||||||0.6625
91737140|NCT00163293|183367445|SUPERIORITY_OR_OTHER|||||||0.7303||95.0|||||Log Rank|||||||0.7303
91737141|NCT00163293|183367446|SUPERIORITY_OR_OTHER|||||||0.1291||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.1291
91737142|NCT00163293|183367446|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.0145
91737143|NCT00163293|183367448|SUPERIORITY_OR_OTHER|||||||0.4754|||||||Kruskal-Wallis|||||||0.4754
91737144|NCT00163293|183367448|SUPERIORITY_OR_OTHER|||||||0.6844|||||||Kruskal-Wallis|||||||0.6844
91498648|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|3.071|||TWO_SIDED|95.0|-8.0|4.81|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.81|-8.00|
91498649|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|6.594|||TWO_SIDED|95.0|-10.21|17.24|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||17.24|-10.21|
91737145|NCT01492426|183367502|NON_INFERIORITY_OR_EQUIVALENCE|Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI \> -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.|Percentage difference|4.3|STANDARD_DEVIATION|3.885|||TWO_SIDED|95.0|-3.3|11.9||Test of noninferiority carried out by taking a confidence interval (CI) for the difference in rates (daclatasvir arm minus telapravir arm). If lower bound of 95% CI difference exceeded -12%, noninferiority was demonstrated. No p-value was computed.|Stratum-adjusted Mantel-Haenszel|||Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.||11.9|-3.3|
91737146|NCT00269113|183367508|SUPERIORITY_OR_OTHER||Difference in percentage of participants|17.4||||0.0009|TWO_SIDED|95.0|6.4|28.4|||Fisher Exact|||||28.4|6.4|0.0009
91737147|NCT00269113|183367509|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91737148|NCT00269113|183367510|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Log Rank|||||||0.0127
91737149|NCT00269113|183367511|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91737150|NCT00269113|183367512|SUPERIORITY_OR_OTHER|||||||0.0186|||||||Log Rank|||||||0.0186
91498650|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|7.155|||TWO_SIDED|95.0|-17.1|12.74|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||12.74|-17.10|
91737151|NCT00269113|183367513|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Log Rank|||||||0.0002
91737152|NCT00269113|183367514|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Log Rank|||||||0.0017
91737153|NCT01114737|183367567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.3||0.085|TWO_SIDED|95.0|-8.9|0.6|||ANCOVA|Adjusted for baseline ADHD-RS/ASRS total score, age group, and ADHD medication.||||0.6|-8.9|0.085
91737154|NCT01114737|183367568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.669|TWO_SIDED|95.0|-1.5|2.3|||ANCOVA|Adjusted for baseline HAMA Anxiety Scale Total Score, age group, ADHD symptom, and ADHD medication.||||2.3|-1.5|0.669
91737155|NCT01114737|183367569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.588|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|Adjusted for Baseline HAM-D Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.9|-1.1|0.588
91737156|NCT01114737|183367570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.531|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|Adjusted for baseline CGI-Severity Response, age group, ADHD symptom, and ADHD medication.||||0.2|-0.4|0.531
91737157|NCT01114737|183367571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.2||0.661|TWO_SIDED|95.0|-5.5|3.6|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||3.6|-5.5|0.661
91737158|NCT01114737|183367572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.9||0.034|TWO_SIDED|95.0|-7.9|-0.3|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||-0.3|-7.9|0.034
91737159|NCT01114737|183367573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.6||0.312|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Adjusted for Week 13 ADHD RS/ASRS Total Score, age group, and ADHD medication.||||7.8|-2.6|0.312
91737160|NCT01114737|183367574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.0||0.59|TWO_SIDED|95.0|-2.4|1.4|||ANCOVA|Adjusted for Week 13 HAMA Anxiety Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.4|-2.4|0.590
91737161|NCT01114737|183367575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.636|TWO_SIDED|95.0|-1.2|1.9|||ANCOVA|Adjusted for Week 13 HAMD Rating Scale Total Score, age group, ADHD symptom, and ADHD||||1.9|-1.2|0.636
91737162|NCT01114737|183367576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|Adjusted for Week 13 Global Impression-Severity Score, ADHD symptom, and ADHD medication.||||0.5|-0.2|0.510
91737163|NCT01114737|183367577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.8||0.395|TWO_SIDED|95.0|-2.1|5.2|||ANCOVA|Adjusted for Week 13 BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.2|-2.1|0.395
91737164|NCT01114737|183367578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.443|TWO_SIDED|95.0|-2.1|4.7|||ANCOVA|Adjusted for Week 13 BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||4.7|-2.1|0.443
91737165|NCT01114737|183367579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.8||0.953|TWO_SIDED|95.0|-5.5|5.8|||ANCOVA|Adjusted for Baseline ADHD-RS/ASRS Total Score, ADHD symptom, and ADHD medication.||||5.8|-5.5|0.953
91737166|NCT01114737|183367580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.733|TWO_SIDED|95.0|-2.4|1.7|||ANCOVA|Adjusted for Baseline Hamilton Anxiety Rating Scale (HAM-A) Score, ADHD symptom, and ADHD medication.||||1.7|-2.4|0.733
91737167|NCT01114737|183367581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.522|TWO_SIDED|95.0|-1.1|2.2|||ANCOVA|Adjusted for Baseline Hamilton Rating Scale For Depression (HAM-D) Score, ADHD symptom, and ADHD medication.||||2.2|-1.1|0.522
91737168|NCT01114737|183367582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.564|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Adjusted for Baseline Clinical Global Impression-Severity (CGI-S), ADHD symptom, and ADHD medication.||||0.4|-0.2|0.564
91498651|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.708|||TWO_SIDED|95.0|-2.42|0.58|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.58|-2.42|
91498652|NCT02801942|182867552|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.372|||TWO_SIDED|95.0|-1.19|0.35|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.35|-1.19|
91498653|NCT02801942|182867554|OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|2.545|||TWO_SIDED|95.0|-11.56|0.78|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.78|-11.56|
91498654|NCT02801942|182867554|OTHER||Mean Difference (Final Values)|-7.03|STANDARD_ERROR_OF_MEAN|7.114|||TWO_SIDED|95.0|-22.22|8.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy FNA method has been presented.|||8.16|-22.22|
91498655|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.358|||TWO_SIDED|95.0|-0.36|1.14|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.14|-0.36|
91498656|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|95.0|-0.25|0.52|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.52|-0.25|
91498657|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-9.02|8.64|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.64|-9.02|
91498658|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-12.57|5.13|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.13|-12.57|
91704711|NCT01260584|183304145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|123.8|||||TWO_SIDED|90.0|98.6|155.4|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Clopidogrel active metabolite R-130964||155.4|98.6|
91498659|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|2.25|STANDARD_ERROR_OF_MEAN|4.034|||TWO_SIDED|95.0|-6.16|10.66|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.66|-6.16|
91704712|NCT02069093|183304155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Incidence rate R|||A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.||||<0.001
91704713|NCT03434249|183304173|OTHER|||||||0.0001|||||||Chi-squared|||"According to the results of a previous trial that looked at a probiotic's effect on infants with CI, it was estimated that when the sample size in each group is 33, the study has 80% power to detect an absolute difference of 35% in the treatment success rate (15% in the Placebo group and 50% in the treatment group) with a 0,05 alpha level.~The number of infants that was included in the study was 80, with an expected maximum dropout rate of 20%."||||0.0001
91704714|NCT03434249|183304174|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91704715|NCT03434249|183304176|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91498660|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|3.994|||TWO_SIDED|95.0|-6.27|10.39|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.39|-6.27|
91498661|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-14.09|9.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.92|-14.09|
91498662|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|4.976|||TWO_SIDED|95.0|-9.91|10.87|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.87|-9.91|
91498663|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-0.67|0.65|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.65|-0.67|
91498664|NCT02801942|182867555|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.325|||TWO_SIDED|95.0|-1.1|0.26|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.26|-1.10|
91498665|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-2.8|16.81|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||16.81|-2.80|
91498666|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|-3.93|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-14.02|6.17|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.17|-14.02|
91498667|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.651|||TWO_SIDED|95.0|-2.69|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.16|-2.69|
91704716|NCT04877535|183304247|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.524|TWO_SIDED|95.0|-0.24|0.12|||t-test, 2 sided|||||0.12|-0.24|0.524
91704717|NCT04877535|183304247|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.403|TWO_SIDED|95.0|-0.4|0.16|||t-test, 2 sided|||||0.16|-0.4|0.403
91704718|NCT04877535|183304248|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.47|2.38|||Fisher Exact|||||2.38|0.47|1.00
91704719|NCT04877535|183304249|SUPERIORITY||Odds Ratio (OR)|4.3|||<|0.001|TWO_SIDED|95.0|1.81|11.13|||Fisher Exact|||||11.13|1.81|<0.001
91704720|NCT04877535|183304249|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.23|4.19|||Fisher Exact|||||4.19|0.23|1.00
91704721|NCT04877535|183304250|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|1.94|39.25|||Fisher Exact|||||39.25|1.94|<0.001
91498668|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.507|||TWO_SIDED|95.0|-3.21|3.24|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.24|-3.21|
91498669|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-2.78|4.33|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.33|-2.78|
91737169|NCT01114737|183367583|SUPERIORITY_OR_OTHER||Relative Risk|0.87||||0.67|TWO_SIDED|95.0|0.46|1.64|||Cochran-Mantel-Haenszel|Adjusted for age group, ADHD symptom, and ADHD medication||||1.64|0.46|0.67
91737170|NCT01114737|183367584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.8||0.833|TWO_SIDED|95.0|-6.2|5.0|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.0|-6.2|0.833
91737171|NCT01114737|183367585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.279|TWO_SIDED|95.0|-6.3|1.8|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||1.8|-6.3|0.279
91737172|NCT00856609|183367635|OTHER||Slope|-624.8||||0.01|TWO_SIDED|95.0|-901.8|-347.8|||ANCOVA|||||-347.8|-901.8|0.01
91737173|NCT00856609|183367636|OTHER||Slope|-24.0||||0.01|TWO_SIDED|95.0|-89.7|41.4|||ANCOVA|||||41.4|-89.7|0.01
91737174|NCT00856609|183367637|OTHER||Slope|-1.48||||0.05|TWO_SIDED|95.0|-3.02|0.05|||ANCOVA|||||0.05|-3.02|0.05
91737175|NCT01788943|183367638|OTHER|||||||0.037|||||||ANOVA|||||||0.037
91498670|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.339|||TWO_SIDED|95.0|-2.75|2.85|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.85|-2.75|
91737176|NCT01788943|183367639|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91498671|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|3.631|||TWO_SIDED|95.0|-8.56|6.63|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.63|-8.56|
91498672|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|-6.03|STANDARD_ERROR_OF_MEAN|2.708|||TWO_SIDED|95.0|-11.69|-0.38|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-0.38|-11.69|
91498673|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.889|||TWO_SIDED|95.0|-1.98|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.78|-1.98|
91498674|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.787|||TWO_SIDED|95.0|-1.07|2.24|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.24|-1.07|
91704722|NCT04877535|183304250|SUPERIORITY||Odds Ratio (OR)|1.63||||0.63|TWO_SIDED|95.0|0.13|14.86|||Fisher Exact|||||14.86|0.13|0.630
91704723|NCT01969084|183304252|SUPERIORITY_OR_OTHER||||||>|0.05||||||A p-value of \< 0.05 was considered statistically significant|Wilcoxon (Mann-Whitney)|||Data were expressed as the median (25th:75th percentiles) for non-normally distributed data. The mean±sd for the groups was not analyzed as per the statistical plan.||||>0.05
91704724|NCT04907227|183304269|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.32|2.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.46|0.32|
91704725|NCT04907227|183304270|OTHER||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|0.68|3.67|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.67|0.68|
91704726|NCT04907227|183304271|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.45|1.5|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.45|
91704727|NCT04907227|183304273|OTHER||Percent Difference|4.3|||||TWO_SIDED|95.0|-24.1|31.2|||||Based on Miettinen \& Nurminen method.|||31.2|-24.1|
91704728|NCT04907227|183304275|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.17|1.99|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.99|0.17|
91704729|NCT04907227|183304276|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.15|18.24|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||18.24|0.15|
91704730|NCT04907227|183304277|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.41|1.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.46|0.41|
91704731|NCT04907227|183304278|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.43|3.17|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.17|0.43|
91704732|NCT01362244|183304282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Fisher Exact|||Statistical data is presented for NR||||0.003
91704733|NCT01362244|183304282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0|||||Fisher Exact|||Statistical data is presented for LOCF||||0.016
91704734|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.71|TWO_SIDED|95.0|0.15|3.64|||Regression, Logistic||Week 1|||3.64|0.15|0.710
91704735|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.674|TWO_SIDED|95.0|0.29|6.87|||Regression, Logistic||Week 2|||6.87|0.29|0.674
91704736|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.942|TWO_SIDED|95.0|0.2|4.49|||Regression, Logistic||Week 5|||4.49|0.20|0.942
91704737|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9||||0.091|TWO_SIDED|95.0|0.8|18.96|||Regression, Logistic||Week 9|||18.96|0.80|0.091
91704738|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.66||||0.004|TWO_SIDED|95.0|2.18|62.33|||Regression, Logistic||Week 13|||62.33|2.18|0.004
91704739|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.74||||0.224|TWO_SIDED|95.0|0.54|13.9|||Regression, Logistic||Week 17|||13.90|0.54|0.224
91704740|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.69|||Regression, Logistic||Week 21|||30.69|1.11|0.037
91498675|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.613|||TWO_SIDED|95.0|-0.85|1.72|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.72|-0.85|
91498676|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|95.0|-0.8|1.56|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.56|-0.80|
91704741|NCT01362244|183304283|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.22||||0.051|TWO_SIDED|95.0|0.99|27.44|||Regression, Logistic||Week 25|||27.44|0.99|0.051
91704742|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.567|TWO_SIDED|95.0|-0.1|0.19|||repeated measures model||Week 2|||0.19|-0.10|0.567
91704743|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05||||0.495|TWO_SIDED|95.0|-0.1|0.21|||repeated measures model||Week 5|||0.21|-0.10|0.495
91704744|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.365|TWO_SIDED|95.0|-0.1|0.28|||repeated measures model||Week 9|||0.28|-0.10|0.365
91704745|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.058|TWO_SIDED|95.0|-0.01|0.34|||repeated measures model||Week 13|||0.34|-0.01|0.058
91704746|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.056|TWO_SIDED|95.0|-0.01|0.43|||repeated measures model||Week 17|||0.43|-0.01|0.056
91704747|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23||||0.028|TWO_SIDED|95.0|0.03|0.42|||repeated measures model||Week 21|||0.42|0.03|0.028
91704748|NCT01362244|183304300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16||||0.077|TWO_SIDED|95.0|-0.02|0.34|||repeated measures model||Week 25|||0.34|-0.02|0.077
91704749|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.486|TWO_SIDED|95.0|-0.1|0.22|||repeated measures model||Week 2|||0.22|-0.10|0.486
91704750|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.384|TWO_SIDED|95.0|-0.08|0.22|||repeated measures model||Week 5|||0.22|-0.08|0.384
91704751|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.546|TWO_SIDED|95.0|-0.14|0.26|||repeated measures model||Week 9|||0.26|-0.14|0.546
91704752|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.39|||repeated measures model||Week 13|||0.39|0.00|0.050
91704753|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.061|TWO_SIDED|95.0|-0.01|0.45|||repeated measures model||Week 17|||0.45|-0.01|0.061
91498677|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|1.546|||TWO_SIDED|95.0|-2.71|3.76|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.76|-2.71|
91498678|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.95|3.79|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|-2.95|
91498679|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.356|||TWO_SIDED|95.0|-4.84|9.14|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.14|-4.84|
91498680|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|2.481|||TWO_SIDED|95.0|-1.25|9.15|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.15|-1.25|
91737177|NCT00783432|183367644|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||This is the Baseline P-Value|ANOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.368
91737178|NCT00783432|183367644|SUPERIORITY_OR_OTHER|||||||0.327||95.0||||This P-Value if for Month 1|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.327
91737179|NCT00783432|183367644|SUPERIORITY_OR_OTHER|||||||0.991||95.0||||This P-Value is for Month 3|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.991
91737180|NCT00783432|183367644|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||This P-Value is for Month 6|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.168
91737181|NCT00783432|183367644|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||This P-Value is for Month 9|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.319
91737182|NCT00783432|183367644|SUPERIORITY_OR_OTHER|||||||0.725||||||This P-Value is for Month 12/ET|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.725
91737183|NCT00186628|183367646|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Log Rank|||||||.07
91737184|NCT01331681|183367649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|97.5|6.5|12.0||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|Least square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||12.0|6.5|<0.0001
91737185|NCT01331681|183367649|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|97.5|6.3|11.8||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||11.8|6.3|<0.0001
91760056|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.37|-0.52||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.52|-1.37|
91760057|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.39|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.39|
91498681|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.627|||TWO_SIDED|95.0|-1.28|1.38|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.38|-1.28|
91760058|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.67|0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.67|
91498682|NCT02801942|182867556|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.438|||TWO_SIDED|95.0|-0.93|0.91|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.91|-0.93|
91498683|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-7.4|8.0|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.00|-7.40|
91498684|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.694|||TWO_SIDED|95.0|-4.9|6.35|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.35|-4.90|
91498685|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.377|||TWO_SIDED|95.0|-9.89|0.08|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.08|-9.89|
91498686|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.682|||TWO_SIDED|95.0|-6.82|0.24|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.24|-6.82|
91737186|NCT01331681|183367650|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|28.7|||<|0.0001|TWO_SIDED|97.5|15.8|41.6||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||41.6|15.8|<0.0001
91737187|NCT01331681|183367650|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|27.5|||<|0.0001|TWO_SIDED|97.5|14.6|40.5||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||40.5|14.6|<0.0001
91737188|NCT01331681|183367651|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|23.3|||<|0.0001|TWO_SIDED|97.5|12.6|33.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||33.9|12.6|<0.0001
91737189|NCT01331681|183367651|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|24.2|||<|0.0001|TWO_SIDED|97.5|13.5|34.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||34.9|13.5|<0.0001
91737190|NCT01331681|183367652|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|25.8|||<|0.0001|TWO_SIDED|97.5|12.2|39.4||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||39.4|12.2|<0.0001
91737191|NCT01331681|183367652|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|19.3||||0.0006|TWO_SIDED|97.5|6.6|32.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||32.1|6.6|0.0006
91737192|NCT01331681|183367653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-157.0|||<|0.0001|TWO_SIDED|97.5|-190.9|-123.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-123.1|-190.9|<0.0001
91737193|NCT01331681|183367653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-142.8|||<|0.0001|TWO_SIDED|97.5|-179.3|-106.3||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A negative value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-106.3|-179.3|<0.0001
91737194|NCT01331681|183367654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.41||||0.2208|TWO_SIDED|97.5|-2.01|6.82||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||6.82|-2.01|0.2208
91498687|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|95.0|-2.67|2.1|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.10|-2.67|
91498688|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.929|||TWO_SIDED|95.0|-7.2|1.59|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.59|-7.20|
91737195|NCT01331681|183367654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21||||0.5537|TWO_SIDED|97.5|-5.79|3.37||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||3.37|-5.79|0.5537
91737196|NCT01331681|183367655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19||||0.5138|TWO_SIDED|97.5|-5.29|2.91|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||2.91|-5.29|0.5138
91737197|NCT01331681|183367655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.8498|TWO_SIDED|97.5|-4.79|4.05|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||4.05|-4.79|0.8498
91737198|NCT05525910|183367656|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|105.03|||||TWO_SIDED|90.0|94.54|116.68||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||116.68|94.54|
91737199|NCT05525910|183367656|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.15|||||TWO_SIDED|90.0|98.08|121.47||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||121.47|98.08|
91737200|NCT05525910|183367656|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.72|||||TWO_SIDED|90.0|90.79|111.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.74|90.79|
91737201|NCT05525910|183367656|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|110.45|||||TWO_SIDED|90.0|99.58|122.52||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.52|99.58|
91737202|NCT05525910|183367657|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.86|||||TWO_SIDED|90.0|93.78|117.24||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||117.24|93.78|
91737203|NCT05525910|183367657|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.7|||||TWO_SIDED|90.0|97.93|122.89||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||122.89|97.93|
91737204|NCT05525910|183367657|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.14|||||TWO_SIDED|90.0|89.69|111.8||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.80|89.69|
91737205|NCT05525910|183367657|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.8|||||TWO_SIDED|90.0|98.36|122.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.57|98.36|
91737206|NCT05525910|183367658|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.85|||||TWO_SIDED|90.0|94.97|127.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||127.06|94.97|
91737207|NCT05525910|183367658|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|114.69|||||TWO_SIDED|90.0|98.92|132.98||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||132.98|98.92|
91737208|NCT05525910|183367658|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.26|||||TWO_SIDED|90.0|94.64|126.14||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||126.14|94.64|
91737209|NCT05525910|183367658|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|115.98|||||TWO_SIDED|90.0|100.48|133.87||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||133.87|100.48|
91737210|NCT05525910|183367659|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|76.24|103.53||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.53|76.24|
91737211|NCT05525910|183367659|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|95.11|||||TWO_SIDED|90.0|81.41|111.11||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||111.11|81.41|
91737212|NCT05525910|183367659|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|85.74|||||TWO_SIDED|90.0|73.73|99.7||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.70|73.73|
91737213|NCT05525910|183367659|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|93.12|||||TWO_SIDED|90.0|80.09|108.26||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||108.26|80.09|
91737214|NCT05525910|183367660|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.43|||||TWO_SIDED|90.0|74.64|104.78||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||104.78|74.64|
91737215|NCT05525910|183367660|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.0|||||TWO_SIDED|90.0|80.8|114.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||114.06|80.80|
91737216|NCT05525910|183367660|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|84.11|||||TWO_SIDED|90.0|71.15|99.43||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.43|71.15|
91737217|NCT05525910|183367660|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|90.99|||||TWO_SIDED|90.0|76.99|107.54||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||107.54|76.99|
91737218|NCT05525910|183367661|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|82.65|||||TWO_SIDED|90.0|65.85|103.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.74|65.85|
91737219|NCT05525910|183367661|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|94.85|||||TWO_SIDED|90.0|75.28|119.49||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||119.49|75.28|
91737220|NCT05525910|183367661|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|81.56|||||TWO_SIDED|90.0|65.18|102.07||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||102.07|65.18|
91737221|NCT05525910|183367661|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|88.38|||||TWO_SIDED|90.0|70.65|110.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||110.57|70.65|
91737222|NCT03498716|183367689|SUPERIORITY|Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.|Hazard Ratio (HR)|1.11||||0.3846|TWO_SIDED|95.0|0.87|1.42|||Log Rank|||||1.42|0.87|0.3846
91737223|NCT00265850|183367749|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.77|1.01|||Log Rank|||||1.01|0.77|0.08
91737224|NCT00265850|183367750|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Log Rank|||||1.08|0.84|0.45
91737225|NCT01918189|183367782|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline.||||||0.008||||||a priori threshold for statistical significance is p \<0.05|Regression, Logistic|||||||0.008
91530930|NCT00050089|182937894|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.49|TWO_SIDED|95.0|0.674|1.275|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation)|Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed.||1.275|0.674|0.49
91530931|NCT00050089|182937895|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Log Rank|||Stratified Log-rank test was used to compare the four treatment||||0.87
91530932|NCT00050089|182937896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.92|TWO_SIDED|95.0|0.75|1.35|||Log Rank||The comparison was Standard-ART (standard) vs Mega-ART (intensification)|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison||1.35|0.75|0.92
91530933|NCT00050089|182937897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.68|TWO_SIDED|95.0|0.8|1.46|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.46|0.8|0.68
91530934|NCT04039503|182937900|SUPERIORITY||LS Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
91530935|NCT04039503|182937900|SUPERIORITY||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
91530936|NCT04039503|182937901|SUPERIORITY||LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.07|||Mixed Models Analysis|||||-1.07|-1.52|<0.001
91530937|NCT04039503|182937902|SUPERIORITY||LS Mean Difference|-7.8|||<|0.001|TWO_SIDED|95.0|-9.4|-6.3|||Mixed Models Analysis|||||-6.3|-9.4|<0.001
91530938|NCT04039503|182937902|SUPERIORITY||LS Mean Difference|-9.9|||<|0.001|TWO_SIDED|95.0|-11.5|-8.3|||Mixed Models Analysis|||||-8.3|-11.5|<0.001
91530939|NCT04039503|182937902|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|95.0|-14.2|-11.0|||Mixed Models Analysis|||||-11.0|-14.2|<0.001
91530940|NCT04039503|182937903|SUPERIORITY||Odds Ratio (OR)|37.77|||<|0.001|TWO_SIDED|95.0|15.23|93.7|||Regression, Logistic|||||93.70|15.23|<0.001
91530941|NCT04039503|182937903|SUPERIORITY||Odds Ratio (OR)|100.07|||<|0.001|TWO_SIDED|95.0|30.02|333.62|||Regression, Logistic|||||333.62|30.02|<0.001
91530942|NCT04039503|182937903|SUPERIORITY||Odds Ratio (OR)|43.31|||<|0.001|TWO_SIDED|95.0|16.92|110.83|||Regression, Logistic|||||110.83|16.92|<0.001
91530943|NCT04039503|182937904|SUPERIORITY||LS Mean Difference|-22.5|||<|0.001|TWO_SIDED|95.0|-29.5|-15.4|||Mixed Models Analysis|||||-15.4|-29.5|<0.001
91530944|NCT04039503|182937904|SUPERIORITY||LS Mean Difference|-29.0|||<|0.001|TWO_SIDED|95.0|-36.0|-22.0|||Mixed Models Analysis|||||-22.0|-36.0|<0.001
91530945|NCT04039503|182937904|SUPERIORITY||LS Mean Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-35.9|-21.6|||Mixed Models Analysis|||||-21.6|-35.9|<0.001
91530946|NCT04039503|182937906|SUPERIORITY||Odds Ratio (OR)|17.15|||<|0.001|TWO_SIDED|95.0|7.55|38.93|||Regression, Logistic|||||38.93|7.55|<0.001
91530947|NCT04039503|182937906|SUPERIORITY||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|11.87|62.55|||Regression, Logistic|||||62.55|11.87|<0.001
91530948|NCT04039503|182937906|SUPERIORITY||Odds Ratio (OR)|79.61|||<|0.001|TWO_SIDED|95.0|32.76|193.44|||Regression, Logistic|||||193.44|32.76|<0.001
91530949|NCT04039503|182937907|SUPERIORITY||Estimate Difference|-35.4|||||TWO_SIDED|95.0|-46.0|-22.8||||||||-22.8|-46.0|
91530950|NCT04039503|182937907|SUPERIORITY||Estimate Difference|-38.2|||||TWO_SIDED|95.0|-48.3|-26.1||||||||-26.1|-48.3|
91530951|NCT04039503|182937907|SUPERIORITY||Estimate Difference|-49.3|||||TWO_SIDED|95.0|-57.7|-39.4||||||||-39.4|-57.7|
91530952|NCT04039503|182937910|SUPERIORITY||Odds Ratio (OR)|12.22|||<|0.001|TWO_SIDED|95.0|3.93|38.0|||Regression, Logistic|||||38.00|3.93|<0.001
91530953|NCT04039503|182937910|SUPERIORITY||Odds Ratio (OR)|32.36|||<|0.001|TWO_SIDED|95.0|10.52|99.49|||Regression, Logistic|||||99.49|10.52|<0.001
91530954|NCT04039503|182937910|SUPERIORITY||Odds Ratio (OR)|56.26|||<|0.001|TWO_SIDED|95.0|18.27|173.26|||Regression, Logistic|||||173.26|18.27|<0.001
91530955|NCT02044458|182937921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||t-test, 2 sided|||||||.70
91530956|NCT02044458|182937922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||t-test, 2 sided|||||||.38
91530957|NCT02044458|182937923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Chi-squared|||||||.57
91530958|NCT02218203|182937924|OTHER|We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.|Lidocaine dose*dextromethorphan dose|0.0042|STANDARD_ERROR_OF_MEAN|0.002||0.0322|TWO_SIDED|95.0|0.0004|0.0081|||Pearson's Chi-squared test||The estimated value is an estimated interaction term, and not a P-value.|We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).||0.0081|0.0004|0.0322
91704754|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.016|TWO_SIDED|95.0|0.05|0.51|||repeated measures model||Week 21|||0.51|0.05|0.016
91704755|NCT01362244|183304301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18||||0.094|TWO_SIDED|95.0|-0.03|0.4|||repeated measures model||Week 25|||0.40|-0.03|0.094
91704756|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.686|TWO_SIDED|95.0|-19.91|30.12|||repeated measures model||Week 2|||30.12|-19.91|0.686
91704757|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.55||||0.321|TWO_SIDED|95.0|-14.4|43.5|||repeated measures model||Week 5|||43.50|-14.40|0.321
91704758|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91||||0.622|TWO_SIDED|95.0|-26.79|44.6|||repeated measures model||Week 9|||44.60|-26.79|0.622
91704759|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.24||||0.178|TWO_SIDED|95.0|-10.75|57.22|||repeated measures model||Week 13|||57.22|-10.75|0.178
91704760|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.16||||0.052|TWO_SIDED|95.0|-0.33|76.66|||repeated measures model||Week 17|||76.66|-0.33|0.052
91704761|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.72||||0.042|TWO_SIDED|95.0|1.41|76.02|||repeated measures model||Week 21|||76.02|1.41|0.042
91704762|NCT01362244|183304302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.13||||0.484|TWO_SIDED|95.0|-25.76|54.02|||repeated measures model||Week 25|||54.02|-25.76|0.484
91704763|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.16||||0.005|TWO_SIDED|95.0|6.49|35.83|||repeated measures model||Week 2|||35.83|6.49|0.005
91704764|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.89||||0.029|TWO_SIDED|95.0|1.77|32.01|||repeated measures model||Week 5|||32.01|1.77|0.029
91704765|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.472|TWO_SIDED|95.0|-12.64|27.03|||repeated measures model||Week 9|||27.03|-12.64|0.472
91704766|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.71||||0.009|TWO_SIDED|95.0|7.19|48.23|||repeated measures model||Week 13|||48.23|7.19|0.009
91704767|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4||||0.114|TWO_SIDED|95.0|-3.8|34.59|||repeated measures model||Week 17|||34.59|-3.80|0.114
91704768|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.51||||0.014|TWO_SIDED|95.0|6.06|52.96|||repeated measures model||Week 21|||52.96|6.06|0.014
91704769|NCT01362244|183304304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.65||||0.027|TWO_SIDED|95.0|3.1|50.21|||repeated measures model||Week 25|||50.21|3.10|0.027
91704770|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.79|TWO_SIDED|95.0|-0.61|0.79|||repeated measures model||MNS, Week 2|||0.79|-0.61|0.790
91704771|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14||||0.008|TWO_SIDED|95.0|0.3|1.97|||repeated measures model||MNS, Week 5|||1.97|0.30|0.008
91704772|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79||||0.066|TWO_SIDED|95.0|-0.05|1.64|||repeated measures model||MNS, Week 9|||1.64|-0.05|0.066
91704773|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73||||0.127|TWO_SIDED|95.0|-0.21|1.67|||repeated measures model||MNS, Week 13|||1.67|-0.21|0.127
91704774|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38||||0.481|TWO_SIDED|95.0|-0.69|1.46|||repeated measures model||MNS, Week 17|||1.46|-0.69|0.481
91704775|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65||||0.308|TWO_SIDED|95.0|-0.61|1.9|||repeated measures model||MNS, Week 21|||1.90|-0.61|0.308
91704776|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.233|TWO_SIDED|95.0|-0.46|1.88|||repeated measures model||MNS, Week 25|||1.88|-0.46|0.233
91704777|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.444|TWO_SIDED|95.0|-0.45|1.02|||repeated measures model||WNS, Week 2|||1.02|-0.45|0.444
91704778|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.31||||0.002|TWO_SIDED|95.0|0.5|2.12|||repeated measures model||WNS, Week 5|||2.12|0.50|0.002
91704779|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68||||0.143|TWO_SIDED|95.0|-0.24|1.6|||repeated measures model||WNS, Week 9|||1.60|-0.24|0.143
91704780|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.24|TWO_SIDED|95.0|-0.42|1.65|||repeated measures model||WNS, Week 13|||1.65|-0.42|0.240
91704781|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-0.98|1.35|||repeated measures model||WNS, Week 17|||1.35|-0.98|0.750
91704782|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.324|TWO_SIDED|95.0|-0.64|1.91|||repeated measures model||WNS, Week 21|||1.91|-0.64|0.324
91704783|NCT01362244|183304305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44||||0.468|TWO_SIDED|95.0|-0.77|1.66|||repeated measures model||WNS, Week 25|||1.66|-0.77|0.468
91704784|NCT01362244|183304306|SUPERIORITY_OR_OTHER_LEGACY||Mixed effects model|-13.2||||0.005|TWO_SIDED|95.0|-22.2|-4.22|||ANCOVA|||||-4.22|-22.2|0.005
91704785|NCT01362244|183304307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||||0.07|-0.06|
91704786|NCT01362244|183304308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.68|||||TWO_SIDED|95.0|-1.33|12.68||||||||12.68|-1.33|
91704787|NCT01253174|183304321|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|102.26||||||90.0|96.65|108.2||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||108.20|96.65|
91704788|NCT01253174|183304322|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|101.13||||||90.0|97.65|104.75||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.75|97.65|
91704789|NCT01253174|183304323|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.66||||||90.0|93.37|104.24||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.24|93.37|
91705650|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-0.81|1.36||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.36|-0.81|0.621
91737226|NCT01918189|183367783|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain intensity at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.27|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.27
91737227|NCT01918189|183367784|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.02|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.02
91737228|NCT01918189|183367785|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.48|TWO_SIDED|||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.48
91737229|NCT01918189|183367786|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of sleep at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.18|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.18
91737230|NCT01918189|183367787|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of depression symptoms at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.03|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.03
91737231|NCT00461708|183367832|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91737232|NCT00461708|183367833|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91737233|NCT02394561|183367835|NON_INFERIORITY|The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was \< 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.|difference|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||||6.2|-8.8|
91737234|NCT02394561|183367838|OTHER|difference between cohorts for PASI 90 using Kaplan-Meier estimate||||||0.1295|||||||Log Rank|||||||0.1295
91737235|NCT02394561|183367838|OTHER|||||||0.447||||||difference between cohorts for PASI 75 using Kaplan-Meier estimate|Log Rank|||||||0.4470
91737236|NCT02394561|183367839|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|At all time points||||||<.0001
91737237|NCT02394561|183367840|SUPERIORITY||||||<|0.0001||||||All time points|Wilcoxon (Mann-Whitney)|||||||<.0001
91737238|NCT02553629|183367845|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91737239|NCT02553629|183367846|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91737240|NCT02553629|183367847|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91737241|NCT02553629|183367848|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91737242|NCT02553629|183367849|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91737243|NCT01812057|183367856|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
91737244|NCT01812057|183367857|SUPERIORITY|Pain Score at rest at 2 hours||||||0.171|||||||t-test, 2 sided|||||||0.171
91737245|NCT01812057|183367857|SUPERIORITY|Pain Score with movement at 2 hours||||||0.204|||||||t-test, 2 sided|||||||0.204
91737246|NCT01812057|183367858|SUPERIORITY|||||||0.1965|||||||Log Rank|||||||0.1965
91737247|NCT01812057|183367859|SUPERIORITY|||||||0.709|||||||Wilcoxon (Mann-Whitney)|||||||0.709
91737248|NCT01812057|183367860|SUPERIORITY|Pain Score at rest at 24 hours||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
91737249|NCT01812057|183367860|SUPERIORITY|Pain Score with movement at 24 hours||||||0.518|||||||t-test, 2 sided|||||||0.518
91737250|NCT01812057|183367861|SUPERIORITY|Pain Score at rest at 48 hours||||||0.491|||||||Wilcoxon (Mann-Whitney)|||||||0.491
91737251|NCT01812057|183367861|SUPERIORITY|Pain Scores with movement at 48 hours||||||0.525|||||||Wilcoxon (Mann-Whitney)|||||||0.525
91737252|NCT01812057|183367862|SUPERIORITY|||||||0.355|||||||Wilcoxon (Mann-Whitney)|Total opioid consumption at 24 hours|||We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.|||0.355
91737253|NCT01812057|183367863|SUPERIORITY|||||||0.42|||||||Fisher Exact|Chronic pain at 8 weeks||||||0.420
91737254|NCT01812057|183367864|SUPERIORITY|||||||0.322|||||||Fisher Exact|||||||0.322
91760059|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.33|-0.49||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.49|-1.33|
91760060|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.9|0.02||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.90|
91704790|NCT01253174|183304324|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.45||||||90.0|96.7|102.28||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.28|96.70|
91704791|NCT01253174|183304325|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.19||||||90.0|99.18|113.68||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.68|99.18|
91498689|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-5.98|3.11|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.11|-5.98|
91498690|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.047|||TWO_SIDED|95.0|-4.59|3.99|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.99|-4.59|
91705651|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|STANDARD_ERROR_OF_MEAN|0.54||0.598|TWO_SIDED|95.0|-0.78|1.35||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.35|-0.78|0.598
91705652|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.923|TWO_SIDED|95.0|-1.1|1.21||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.21|-1.10|0.923
91705653|NCT01026818|183305794|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.857|TWO_SIDED|95.0|-1.03|1.24||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.24|-1.03|0.857
91498691|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.645|||TWO_SIDED|95.0|-6.99|4.06|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.06|-6.99|
91498692|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|2.185|||TWO_SIDED|95.0|-4.05|5.11|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.11|-4.05|
91705654|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|14.87|STANDARD_ERROR_OF_MEAN|5.57||0.008|TWO_SIDED|95.0|3.92|25.83||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.83|3.92|0.008
91705655|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|11.34|STANDARD_ERROR_OF_MEAN|5.45||0.038|TWO_SIDED|95.0|0.63|22.04||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.04|0.63|0.038
91705656|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|8.91|STANDARD_ERROR_OF_MEAN|6.15||0.148|TWO_SIDED|95.0|-3.18|21.0||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||21.00|-3.18|0.148
91705657|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|5.37|STANDARD_ERROR_OF_MEAN|6.03||0.373|TWO_SIDED|95.0|-6.48|17.23||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.23|-6.48|0.373
91705658|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|10.9|STANDARD_ERROR_OF_MEAN|4.96||0.029|TWO_SIDED|95.0|1.14|20.66||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.66|1.14|0.029
91705659|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|4.53|STANDARD_ERROR_OF_MEAN|4.91||0.357|TWO_SIDED|95.0|-5.12|14.17||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||14.17|-5.12|0.357
91705660|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|16.33|STANDARD_ERROR_OF_MEAN|5.42||0.003|TWO_SIDED|95.0|5.68|26.98||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||26.98|5.68|0.003
91705661|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|6.62|STANDARD_ERROR_OF_MEAN|5.3||0.212|TWO_SIDED|95.0|-3.8|17.04||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.04|-3.80|0.212
91705662|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|4.55|STANDARD_ERROR_OF_MEAN|6.17||0.461|TWO_SIDED|95.0|-7.58|16.68||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.68|-7.58|0.461
91737255|NCT01812057|183367865|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||24 hour pain scores at rest between MTS groups|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.|||0.805
91737256|NCT01812057|183367865|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Pain scores on movement at 24h|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.|||1.000
91737257|NCT01812057|183367866|SUPERIORITY|Intraoperative nausea and vomiting||||||0.245|||||||Fisher Exact|||||||0.245
91737258|NCT01812057|183367866|SUPERIORITY|||||||0.676|||||||Chi-squared|Need for intraoperative antiemetics||||||0.676
91737259|NCT01812057|183367866|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91737260|NCT01812057|183367868|SUPERIORITY|||||||0.924|||||||Chi-squared|Incidence of postoperative pruritus||||||0.924
91737261|NCT01812057|183367869|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.700
91737262|NCT01812057|183367870|SUPERIORITY|||||||0.302|||||||Chi-squared|Incidence of PONV at 24 h||||||0.302
91737263|NCT01812057|183367870|SUPERIORITY|||||||0.028|||||||Chi-squared|Postoperative need for rescue antiemetic||||||0.028
91737264|NCT01812057|183367870|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91737265|NCT01812057|183367870|SUPERIORITY|||||||0.188|||||||Chi-squared|||||||0.188
91737266|NCT01259011|183367877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.1|3.3|||Mixed Models Analysis|||||3.3|1.1|<.05
91737267|NCT01259011|183367878|SUPERIORITY||Slope|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||HADS-anxiety|Regression, Linear|||||0.3|-2.8|0.12
91737268|NCT01259011|183367878|SUPERIORITY||Slope|-2.2|||<|0.05|TWO_SIDED|95.0|-4.2|-0.3||HADS-depression|Regression, Linear|||||-0.3|-4.2|<0.05
91737269|NCT01259011|183367879|SUPERIORITY||Slope|-4.0||||0.21|TWO_SIDED|95.0|-10.2|2.2|||Regression, Linear|||||2.2|-10.2|0.21
91737270|NCT01180127|183367881|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Repeated measures ANOVA|||Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.||||.0001
91737271|NCT01180127|183367882|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise|ANCOVA|||ANCOVA used to test main effect of flavanol||||0.038
91737272|NCT01180127|183367882|SUPERIORITY_OR_OTHER|||||||0.815|TWO_SIDED|||||The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol|ANCOVA|||ANCOVA used to test main effect of exercise||||0.815
91737273|NCT01180127|183367883|SUPERIORITY_OR_OTHER|||||||0.853|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of flavanol||||0.853
91737274|NCT01180127|183367883|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of exercise||||0.581
91737275|NCT01180127|183367884|SUPERIORITY_OR_OTHER|||||||0.237|TWO_SIDED||||||ANCOVA|||ANCOVA was used to test for an exercise effect.||||0.237
91737276|NCT01854528|183367910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.26|||<|0.001|TWO_SIDED|95.0|21.09|47.42|||Stratum adjusted Mantel-Haenszel|||P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.||47.42|21.09|<0.001
91737277|NCT01854528|183367911|SUPERIORITY_OR_OTHER||LS mean difference|8.64|||<|0.001|TWO_SIDED|95.0|5.43|11.85|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||11.85|5.43|<0.001
91737278|NCT01854528|183367912|SUPERIORITY_OR_OTHER||LS mean difference|7.55|||<|0.001|TWO_SIDED|95.0|5.11|9.98|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||9.98|5.11|<0.001
91737279|NCT01854528|183367913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|54.7|||<|0.001|TWO_SIDED|95.0|6.9|435.1|||Regression, Logistic|||P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.||435.1|6.9|<0.001
91737280|NCT03060902|183367934|SUPERIORITY||F|10.16||||0.002|TWO_SIDED||||||ANOVA|||||||.002
91737281|NCT00833521|183367948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|91.1||||||90.0|86.3|96.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.1|86.3|
91737282|NCT00833521|183367949|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.0||||||90.0|91.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.0|
91737283|NCT00833521|183367950|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.8||||||90.0|90.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|90.7|
91737284|NCT02735421|183367976|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91737285|NCT01978145|183367985|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by CB DPI versus FSC administered BID by MD DPI is greater than -45 milliliter (mL).|Mean Difference (Net)|0.025|||||TWO_SIDED|95.0|0.002|0.047|||Repeated Measures Mixed Models|||||0.047|0.002|
91737286|NCT01978145|183367986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.019|0.027|||||The estimated value and 95% CI values are provided for Day 28|||0.027|-0.019|
91498693|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.23|6.73|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.73|-11.23|
91498694|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|3.42|STANDARD_ERROR_OF_MEAN|3.472|||TWO_SIDED|95.0|-3.84|10.67|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.67|-3.84|
91498695|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.153|||TWO_SIDED|95.0|-3.3|2.0|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.00|-3.30|
91498696|NCT02801942|182867557|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.869|||TWO_SIDED|95.0|-2.06|1.72|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.72|-2.06|
91498697|NCT02801942|182867558|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.304|||TWO_SIDED|95.0|-2.27|3.19|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.19|-2.27|
91498698|NCT02801942|182867558|OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.056|||TWO_SIDED|95.0|-3.24|1.36|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.36|-3.24|
91498699|NCT02801942|182867559|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|5.069|||TWO_SIDED|95.0|-11.91|9.58|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.58|-11.91|
91498700|NCT02801942|182867559|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|5.301|||TWO_SIDED|95.0|-15.85|7.1|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.10|-15.85|
91498701|NCT02801942|182867559|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.374|||TWO_SIDED|95.0|-1.62|4.59|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.59|-1.62|
91737287|NCT01978145|183367986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|||||TWO_SIDED|95.0|-0.005|0.044|||||The estimated value and 95% CI values are provided for Day 56|||0.044|-0.005|
91737288|NCT01978145|183367987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166||||||95.0|-0.06|0.393||||||||0.393|-0.060|
91498702|NCT02801942|182867559|OTHER||Mean Difference (Final Values)|2.91|STANDARD_ERROR_OF_MEAN|1.291|||TWO_SIDED|95.0|-0.05|5.88|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.88|-0.05|
91498703|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|4.86|STANDARD_ERROR_OF_MEAN|3.083|||TWO_SIDED|95.0|-1.6|11.31|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||11.31|-1.60|
91498704|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|8.21|STANDARD_ERROR_OF_MEAN|6.78|||TWO_SIDED|95.0|-6.15|22.57|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||22.57|-6.15|
91498705|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|-11.19|STANDARD_ERROR_OF_MEAN|5.812|||TWO_SIDED|95.0|-23.48|1.11|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.11|-23.48|
91498706|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|-5.89|STANDARD_ERROR_OF_MEAN|3.855|||TWO_SIDED|95.0|-14.14|2.37|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.37|-14.14|
91498707|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|1.65|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-3.54|6.84|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.84|-3.54|
91498708|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|2.937|||TWO_SIDED|95.0|-3.84|8.98|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||8.98|-3.84|
91498709|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|2.781|||TWO_SIDED|95.0|-2.67|9.12|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.12|-2.67|
91498710|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.337|||TWO_SIDED|95.0|0.55|6.21|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.21|0.55|
91498711|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|4.736|||TWO_SIDED|95.0|-11.49|8.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.58|-11.49|
91498712|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|1.88|STANDARD_ERROR_OF_MEAN|4.142|||TWO_SIDED|95.0|-6.81|10.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.58|-6.81|
91498713|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|5.79|||TWO_SIDED|95.0|-2.01|22.92|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||22.92|-2.01|
91498714|NCT02801942|182867560|OTHER||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|4.913|||TWO_SIDED|95.0|-4.24|16.59|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.59|-4.24|
91737289|NCT01978145|183367988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.278|0.272|||||The estimated and 95% CI values are presented for Day 28.|||0.272|-0.278|
91737290|NCT01978145|183367988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.069||||||95.0|-0.349|0.212|||||The estimated and 95% CI values are presented for Day 56.|||0.212|-0.349|
91737291|NCT01978145|183367988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.133|||||TWO_SIDED|95.0|-0.413|0.148|||||The estimated and 95% CI values are presented for Day 85.|||0.148|-0.413|
91737292|NCT01978145|183367989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.7|1.19||||||||1.19|-0.70|
91737293|NCT01978145|183367990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.1|-0.02||||||||-0.02|-1.10|
91737294|NCT00755807|183367998|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week,participant random effect.||Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.||||0.001
91737295|NCT00755807|183367999|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.027
91498715|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.696|||TWO_SIDED|95.0|-0.08|2.83|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.83|-0.08|
91737296|NCT00755807|183367999|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.246
91498716|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.324|||TWO_SIDED|95.0|-0.61|4.98|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.98|-0.61|
91498717|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|6.389|||TWO_SIDED|95.0|-14.66|12.85|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||12.85|-14.66|
91498718|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|-4.19|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|-14.71|6.33|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.33|-14.71|
91498719|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.234|||TWO_SIDED|95.0|-2.73|2.47|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.47|-2.73|
91498720|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.859|||TWO_SIDED|95.0|-1.45|2.28|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.28|-1.45|
91498721|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|0.64|5.78|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.78|0.64|
91498722|NCT02801942|182867561|OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|0.712|||TWO_SIDED|95.0|0.75|3.79|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|0.75|
91737297|NCT00755807|183367999|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.024
91737298|NCT00755807|183367999|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.165
91737299|NCT00755807|183368000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.121|TWO_SIDED|95.0|-0.06|0.49||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.|The mean difference is for placebo - duloxetine.|||0.49|-0.06|0.121
91737300|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.016|TWO_SIDED|95.0|0.12|1.2||P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.20|0.12|0.016
91737301|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95||P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.95|0.02|0.043
91704792|NCT01253174|183304326|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|97.98||||||90.0|94.19|101.93||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.93|94.19|
91704793|NCT01253174|183304327|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|104.9||||||90.0|98.83|111.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||111.34|98.83|
91704794|NCT01253174|183304328|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.63||||||90.0|95.73|103.69||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.69|95.73|
91704795|NCT01253174|183304330|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.57||||||90.0|97.32|101.87||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.87|97.32|
91704796|NCT02267135|183304333|SUPERIORITY_OR_OTHER_LEGACY||Difference between percentages|51.0|||<|0.001|TWO_SIDED|95.0|37.0|65.0|||Cochran-Mantel-Haenszel|adjusted for body weight (\< 90 kg, ≥ 90 kg)||||65|37|<0.001
91737302|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.05|0.99||P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.99|0.05|0.030
91737303|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.001|TWO_SIDED|95.0|0.36|1.43||P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.43|0.36|0.001
91737304|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.083|TWO_SIDED|95.0|-0.07|1.11||P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.11|-0.07|0.083
91498723|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|0.4|6.15|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.15|0.40|
91498724|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|2.109|||TWO_SIDED|95.0|-1.68|7.17|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.17|-1.68|
91498725|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|6.712|||TWO_SIDED|95.0|-14.49|14.48|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||14.48|-14.49|
91498726|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.947|||TWO_SIDED|95.0|-12.67|4.43|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.43|-12.67|
91498727|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|2.967|||TWO_SIDED|95.0|-5.48|8.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.13|-5.48|
91498728|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|2.287|||TWO_SIDED|95.0|-4.36|6.84|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.84|-4.36|
91498729|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|95.0|0.54|4.84|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.84|0.54|
91704797|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental,control) × 2(Activity: singing,verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, believability of thought were equivalent across time||||<0.001
91737305|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.034|TWO_SIDED|95.0|0.05|1.27||P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.27|0.05|0.034
91737306|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.089|TWO_SIDED|95.0|-0.08|1.19||P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.19|-0.08|0.089
91737307|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.291|TWO_SIDED|95.0|-0.28|0.93||P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.93|-0.28|0.291
91737308|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.077|TWO_SIDED|95.0|-0.06|1.05||P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.05|-0.06|0.077
91737309|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.148|TWO_SIDED|95.0|-0.15|0.97||P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.97|-0.15|0.148
91737310|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.582|TWO_SIDED|95.0|-0.45|0.79||P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-0.45|0.582
91737311|NCT00755807|183368001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.067|TWO_SIDED|95.0|-0.03|0.94||P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.94|-0.03|0.067
91737312|NCT00755807|183368002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.041|TWO_SIDED|95.0|0.01|0.45||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.45|0.01|0.041
91737313|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5|TWO_SIDED|95.0|-3.9|1.91||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.91|-3.90|0.500
91737314|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.512|TWO_SIDED|95.0|-4.87|2.44||P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.44|-4.87|0.512
91737315|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.72|TWO_SIDED|95.0|-4.51|3.12||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.12|-4.51|0.720
91737316|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.973|TWO_SIDED|95.0|-3.58|3.46||P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.46|-3.58|0.973
91737317|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.991|TWO_SIDED|95.0|-4.07|4.02||P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.02|-4.07|0.991
91760061|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-1.32|-0.41||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.41|-1.32|
91498730|NCT02801942|182867562|OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.737|||TWO_SIDED|95.0|0.03|3.13|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.13|0.03|
91498731|NCT00254540|182867581|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|48.0||||||95.0|27.8|68.7||||||||68.7|27.8|
91498732|NCT00254540|182867581|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|46.2||||||95.0|26.6|66.6||||||||66.6|26.6|
91705663|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.26|STANDARD_ERROR_OF_MEAN|6.05||0.835|TWO_SIDED|95.0|-13.16|10.63||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.63|-13.16|0.835
91705664|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|13.36|STANDARD_ERROR_OF_MEAN|6.15||0.03|TWO_SIDED|95.0|1.27|25.46||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.46|1.27|0.030
91705665|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|5.96|STANDARD_ERROR_OF_MEAN|6.07||0.326|TWO_SIDED|95.0|-5.97|17.89||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.89|-5.97|0.326
91705666|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|12.06|STANDARD_ERROR_OF_MEAN|5.13||0.019||95.0|1.98|22.15||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.15|1.98|0.019
91705667|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|2.48|STANDARD_ERROR_OF_MEAN|5.02||0.621|TWO_SIDED|95.0|-7.38|12.35||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.35|-7.38|0.621
91705668|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|5.73||0.968||95.0|-11.03|11.49||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||11.49|-11.03|0.968
91705669|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.51|STANDARD_ERROR_OF_MEAN|5.62||0.327|TWO_SIDED|95.0|-16.55|5.54||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.54|-16.55|0.327
91705670|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|11.67|STANDARD_ERROR_OF_MEAN|6.32||0.066|TWO_SIDED|95.0|-0.76|24.09||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||24.09|-0.76|0.066
91705671|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|5.09|STANDARD_ERROR_OF_MEAN|6.23||0.415|TWO_SIDED|95.0|-7.17|17.34||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.34|-7.17|0.415
91705672|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|11.87|STANDARD_ERROR_OF_MEAN|4.61||0.011|TWO_SIDED|95.0|2.79|20.94||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.94|2.79|0.011
91705673|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|3.85|STANDARD_ERROR_OF_MEAN|4.51||0.394|TWO_SIDED|95.0|-5.03|12.72||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.72|-5.03|0.394
91705674|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.94|STANDARD_ERROR_OF_MEAN|4.75||0.684|TWO_SIDED|95.0|-11.28|7.41||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.41|-11.28|0.684
91705675|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|-7.14|STANDARD_ERROR_OF_MEAN|4.66||0.126|TWO_SIDED|95.0|-16.3|2.02||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.02|-16.30|0.126
91705676|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|11.52|STANDARD_ERROR_OF_MEAN|6.13||0.061|TWO_SIDED|95.0|-0.53|23.57||P-value is for Q4 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.57|-0.53|0.061
91705677|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|5.06|STANDARD_ERROR_OF_MEAN|6.05||0.403|TWO_SIDED|95.0|-6.83|16.95||P-value is for Q4 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.95|-6.83|0.403
91705678|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|11.38|STANDARD_ERROR_OF_MEAN|4.58||0.013||95.0|2.38|20.38||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.38|2.38|0.013
91705679|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|3.69|STANDARD_ERROR_OF_MEAN|4.47||0.41|TWO_SIDED|95.0|-5.11|12.49||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.49|-5.11|0.410
91705680|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|-2.85|STANDARD_ERROR_OF_MEAN|4.61||0.537|TWO_SIDED|95.0|-11.92|6.22||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.22|-11.92|0.537
91704798|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in believability of thought from baseline to post-intervention. Null hypothesis: there would be no significant difference in believability of thought from baseline to post-intervention||||<0.001
91704799|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences from post-intervention to follow-up. Null hypothesis: there would be no significant differences in believability of thought from post-intervention to follow-up.||||<0.001
91704800|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal believability scores||||>0.05
91704801|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal believability scores||||>0.05
91704802|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in believability scores||||>0.05
91704803|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent believability scores across time.||||>0.05
91704804|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on believability scores||||>0.05
91705681|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|-8.59|STANDARD_ERROR_OF_MEAN|4.52||0.058|TWO_SIDED|95.0|-17.48|0.3||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.30|-17.48|0.058
91498733|NCT01313767|182867597|NON_INFERIORITY_OR_EQUIVALENCE|90% of the power, 0.45 of non-inferiority margin|Mean Difference (Final Values)|0.17||||0.1347|TWO_SIDED|95.0|-0.05|0.4|||t-test, 2 sided|||The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.||0.40|-0.05|0.1347
91737318|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14||||0.441|TWO_SIDED|95.0|-11.14|4.87||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-11.14|0.441
91737319|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.108|TWO_SIDED|95.0|-7.94|0.79||P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-7.94|0.108
91737320|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.948|TWO_SIDED|95.0|-5.77|5.39||P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.39|-5.77|0.948
91737321|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96||||0.374|TWO_SIDED|95.0|-2.37|6.28||P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||6.28|-2.37|0.374
91737322|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.867|TWO_SIDED|95.0|-4.1|4.87||P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-4.10|0.867
91737323|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77||||0.306|TWO_SIDED|95.0|-1.63|5.17||P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.17|-1.63|0.306
91737324|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.733|TWO_SIDED|95.0|-4.08|2.88||P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.88|-4.08|0.733
91498734|NCT01313767|182867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2591|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.||||0.2591
91737325|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.283|TWO_SIDED|95.0|-13.88|4.08||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.08|-13.88|0.283
91737326|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.664|TWO_SIDED|95.0|-4.49|2.86||P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.86|-4.49|0.664
91737327|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98||||0.504|TWO_SIDED|95.0|-7.81|3.85||P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.85|-7.81|0.504
91737328|NCT00755807|183368003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.27|TWO_SIDED|95.0|-11.18|3.14||P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.14|-11.18|0.270
91737329|NCT00755807|183368004|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.119
91737330|NCT00755807|183368004|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
91737331|NCT00755807|183368004|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
91737332|NCT00755807|183368005|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week; participant=random effect.||||||0.002
91737333|NCT00755807|183368006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.662|TWO_SIDED|95.0|-0.06|0.04||P-value is for treatment comparison of change from baseline on BDI-II Question #9 score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.04|-0.06|0.662
91704805|NCT03646305|183304379|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on believability||||>0.05
91704806|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appraisal of target thought were equivalent across time.||||<0.001
91704807|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.005|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent across time.||||=0.005
91704808|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.002|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in negativity from baseline to post-intervention||||=0.002
91704809|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in negativity from post-intervention to follow-up.||||<0.001
91704810|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: there would be no significant difference in negativity scores from baseline to post-intervention in the experimental conditions||||>0.025
91704811|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the experimental conditions would have no significant difference in negativity scores from post-intervention to follow-up.||||>0.025
91705682|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|11.44|STANDARD_ERROR_OF_MEAN|6.09||0.061|TWO_SIDED|95.0|-0.54|23.41||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.41|-0.54|0.061
91705683|NCT01026818|183305805|SUPERIORITY_OR_OTHER||LS Mean Differences|5.59|STANDARD_ERROR_OF_MEAN|6.01||0.353|TWO_SIDED|95.0|-6.23|17.4||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.40|-6.23|0.353
91705684|NCT01026818|183305806|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.12|STANDARD_ERROR_OF_MEAN|3.66||0.162|TWO_SIDED|95.0|-12.32|2.08|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||2.08|-12.32|0.162
91705685|NCT01026818|183305806|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.88|STANDARD_ERROR_OF_MEAN|3.61||0.603||95.0|-8.99|5.24|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||5.24|-8.99|0.603
91498735|NCT01313767|182867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.3395|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.||||0.3395
91498736|NCT01313767|182867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0675|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.||||0.0675
91704812|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal negativity scores||||>0.05
91704813|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal negativity scores||||>0.05
91705686|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|3.49|STANDARD_ERROR_OF_MEAN|2.7||0.196|TWO_SIDED|95.0|-1.82|8.8||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||8.80|-1.82|0.196
91737334|NCT00755807|183368007|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||This is the P-value for Discontinuation Due to Any Reason.|Fisher Exact|||||||0.244
91737335|NCT00755807|183368007|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||This is the P-value for Adverse Event (AE).|Fisher Exact|||||||0.012
91530959|NCT05220501|182937951|NON_INFERIORITY|The justification of the noninferiority margin is based on review of 11 studies reporting on the benefit of multiparametric MRI-directed biopsy over systematic biopsy. The differences between the multiparametric MRI-directed biopsy and systematic biopsy were tabulated and found to range from 5%to 18%. Panel selected 10% noninferiority and a 1-sided α of .025 as a reasonable threshold that would demonstrate clinically similar outcomes.|||||<|0.001|||||||Jeffreys interval|||||||<0.001
91737336|NCT00755807|183368007|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||This is the P-value for Protocol Violation.|Fisher Exact|||||||0.622
91737337|NCT00755807|183368007|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Subject Decision.|Fisher Exact|||||||1.00
91705687|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|0.53|STANDARD_ERROR_OF_MEAN|2.65||0.841|TWO_SIDED|95.0|-4.69|5.75||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.75|-4.69|0.841
91737338|NCT00755807|183368007|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Lack of Efficacy.|Fisher Exact|||||||1.00
91737339|NCT00755807|183368007|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Physician Decision.|Fisher Exact|||||||1.00
91737340|NCT00755807|183368010|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for treatment comparison of change from baseline on Bicarbonate, HCO3. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.047
91737341|NCT00755807|183368011|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value is for treatment comparison of change from baseline on creatinine. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.033
91737342|NCT00755807|183368012|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for treatment comparison of change from baseline on platelet count. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from baseline = Treatment + Investigator.||||||0.034
91737343|NCT00755807|183368013|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value is for treatment comparison of change from baseline on inorganic phosphorus. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.007
91737344|NCT00755807|183368014|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for treatment comparison of change from baseline on uric acid. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.025
91737345|NCT00755807|183368015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.322|TWO_SIDED|95.0|-2.55|0.84||P-value is for treatment comparison of change from baseline on diastolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.84|-2.55|0.322
91737346|NCT00755807|183368015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.787|TWO_SIDED|95.0|-3.32|2.52||P-value is for treatment comparison of change from baseline on systolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.52|-3.32|0.787
91737347|NCT00755807|183368016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.16|TWO_SIDED|95.0|-3.7|0.61||P-value is for treatment comparison of change from baseline on pulse rate. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.61|-3.70|0.160
91530960|NCT00802841|182937954|SUPERIORITY_OR_OTHER|||||||0.3106|TWO_SIDED||||||Fisher Exact|||||||0.3106
91737348|NCT00755807|183368017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.003|TWO_SIDED|95.0|0.27|1.26||P-value is for treatment comparison of change from baseline on weight. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.26|0.27|0.003
91737349|NCT00755807|183368018|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean PGI-I score at 18 weeks for all participants who entered extension phase.||||||<0.001
91737350|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Worst Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.||||||<0.001
91737351|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.||||||<0.001
91737352|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.||||||<0.001
91498737|NCT01313767|182867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0605|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.||||0.0605
91737353|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.||||||<0.001
91737354|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.||||||<0.001
91737355|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.||||||<0.001
91737356|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.||||||<0.001
91498738|NCT01313767|182867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0429|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.||||0.0429
91498739|NCT01313767|182867600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.6954|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.||||0.6954
91704814|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in negativity scores||||>0.05
91737357|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.||||||<0.001
91737358|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.||||||<0.001
91498740|NCT01313767|182867600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.6024|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.||||0.6024
91498741|NCT01313767|182867600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9316|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.||||0.9316
91704815|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on negativity scores||||>0.05
91704816|NCT03646305|183304380|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on negativity scores||||>0.05
91704817|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at p\< .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of discomfort were equivalent across time.||||<0.001
91704818|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from baseline to post-intervention. Null hypothesis: there would have no significant differences in discomfort levels from baseline to post-intervention across samples||||<0.001
91737359|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.||||||<0.001
91737360|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.||||||<0.001
91498742|NCT01313767|182867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.2284|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.||||0.2284
91498743|NCT01313767|182867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.3221|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.||||0.3221
91498744|NCT01313767|182867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.593|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.||||0.5930
91704819|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from post-intervention to follow-up. Null hypothesis: there would be no significant differences in discomfort levels from post-intervention to follow-up across samples||||<0.001
91737361|NCT00755807|183368019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.||||||<0.001
91737362|NCT00755807|183368020|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.||||||<0.001
91737363|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.||||||0.002
91737364|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.||||||0.054
91737365|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.||||||0.002
91737366|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.||||||0.025
91737367|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.||||||0.008
91737368|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.||||||0.858
91737369|NCT00755807|183368021|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.||||||<0.001
91737370|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.||||||0.637
91737371|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.||||||0.051
91737372|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.||||||0.270
91530961|NCT05160025|182937962|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent with correction (x3) indicated the following: self-competition \> feedback (p \< 0.001) other-competition \> feedback (p \< 0.001) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
91737373|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.||||||0.061
91737374|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.||||||0.007
91737375|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.||||||0.253
91737376|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.942||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.||||||0.942
91737377|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.||||||0.016
91737378|NCT00755807|183368021|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.||||||0.381
91760062|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-1.53|-0.62||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-1.53|
91737379|NCT00755807|183368023|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline\*Week; participant was treated as random effect.||||||0.524
91737380|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737381|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737382|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737383|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737384|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737385|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737386|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737387|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 15). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91498745|NCT01313767|182867602|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.1585|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.1585
91498746|NCT01313767|182867602|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0028||||0.9596|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.9596
91498747|NCT01313767|182867602|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0304||||0.6164|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.6164
91737388|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 16). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737389|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 17). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91737390|NCT00755807|183368023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 18). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
91498748|NCT01313767|182867603|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.1802|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1802
91498749|NCT01313767|182867603|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1164||||0.1176|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1176
91498750|NCT01313767|182867603|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1138||||0.1252|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1252
91498751|NCT01313767|182867604|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.3431|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.||||0.3431
91498752|NCT01313767|182867604|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1097||||0.1329|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test||||0.1329
91737391|NCT00755807|183368024|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|1-sample t-test of mean change from extension phase baseline to endpoint on BDI-II Question #9 score for all participants who entered extension phase.||||||0.706
91498753|NCT01313767|182867604|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0853||||0.2611|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test||||0.2611
91498754|NCT01313767|182867605|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0654||||0.4623|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.4623
91498755|NCT01313767|182867605|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1194||||0.2007|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.2007
91498756|NCT01313767|182867605|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0172||||0.8553|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.8553
91530962|NCT05160025|182937965|SUPERIORITY|||||||0.111||||||"rmANOVA p = 0.111~post hoc paired t-tests not performed"|ANOVA|||||||0.111
91530963|NCT05160025|182937968|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.003) other-competition \> feedback (p = 0.007) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
91704820|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of discomfort||||>0.05
91704821|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of discomfort||||>0.05
91704822|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of discomfort||||>0.05
91704823|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of discomfort across time||||>0.05
91705688|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|1.98|STANDARD_ERROR_OF_MEAN|2.76||0.474|TWO_SIDED|95.0|-3.45|7.4||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.40|-3.45|0.474
91498757|NCT01313767|182867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.6040
91498758|NCT01313767|182867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.3233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.3233
91530964|NCT05160025|182937971|SUPERIORITY||||||>|0.05||||||"rmANOVA p \> 0.05 with a partial eta squared effect size = 0.073~post hoc paired t-tests not performed"|ANOVA|||||||> 0.05
91530965|NCT05160025|182937976|SUPERIORITY|||||||0.004||||||"rmANOVA = 0.004~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.007) other-competition \> feedback (p = 0.002) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||0.004
91530966|NCT05160025|182937984|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
91737392|NCT00755807|183368028|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on monocytes.||||||0.035
91737393|NCT00755807|183368029|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on sodium.||||||0.042
91737394|NCT00755807|183368030|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on total protein.||||||0.036
91737395|NCT00755807|183368031|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on diastolic blood pressure.||||||0.320
91737396|NCT00755807|183368031|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on systolic blood pressure.||||||0.182
91737397|NCT00755807|183368032|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on pulse rate.||||||0.032
91737398|NCT00755807|183368033|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on weight.||||||0.151
91737399|NCT01714323|183368034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||>|0.05|TWO_SIDED|95.0|0.84|1.37|||Chi-squared|||Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.||1.37|0.84|>0.05
91737400|NCT01714323|183368035|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91737401|NCT01714323|183368036|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This compares at Month 1||||<0.001
91737402|NCT01714323|183368036|SUPERIORITY||||||<|0.01|||||||Chi-squared|||This is analysis for Month 3||||<0.01
91737403|NCT01714323|183368036|SUPERIORITY||||||<|0.09|||||||Chi-squared|||This is for Month 6||||<0.09
91737404|NCT01714323|183368038|SUPERIORITY_OR_OTHER||||||<|0.001||||||This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.|Chi-squared|||||||<0.001
91737405|NCT01714323|183368039|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91737406|NCT01714323|183368040|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91737407|NCT01585025|183368068|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.007
91737408|NCT01585025|183368068|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.11
91737409|NCT01585025|183368068|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.12
91498759|NCT01313767|182867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.4469
91737410|NCT01585025|183368069|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.72
91498760|NCT01313767|182867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1220
91498761|NCT01313767|182867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.1016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1016
91737411|NCT01585025|183368069|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.51
91737412|NCT01585025|183368069|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.13
91737413|NCT01585025|183368070|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.03
91737414|NCT01585025|183368070|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.11
91737415|NCT01585025|183368070|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.02
91737416|NCT01585025|183368071|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
91737417|NCT01585025|183368071|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.04
91737418|NCT01585025|183368071|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
91737419|NCT01585025|183368072|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.03
91737420|NCT01585025|183368072|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.17
91737421|NCT01585025|183368072|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.31
91737422|NCT01585025|183368073|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.05
91737423|NCT01585025|183368073|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.04
91737424|NCT01585025|183368073|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.74
91737425|NCT01585025|183368074|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.005
91737426|NCT01585025|183368074|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.03
91737427|NCT01585025|183368074|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.61
91498762|NCT01313767|182867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.2235|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.2235
91498763|NCT01313767|182867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.503|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.5030
91498764|NCT01313767|182867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.6934|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.6934
91530967|NCT05160025|182937985|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
91737428|NCT02122380|183368095|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of mean growth hormone (GH) levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided). A sample size of 16 participants was needed to provide 93% power to detect a difference in GH means of 0.5 mcg/L.||||0.918
91737429|NCT02122380|183368096|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of early insulin secretion between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.054
91737430|NCT02122380|183368097|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in blood glucose levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.009
91737431|NCT02122380|183368098|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in the mass of visceral adipose tissue after sitagliptin vs. placebo. The test was performed with a significance level of 0.05 (two sided).||||0.022
91737432|NCT02122380|183368099|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in vascular function between sitagliptin and placebo treatments. The test was performed with a significance level of 0.05 (two sided).||||0.943
91737433|NCT00688467|183368102|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|26.0|STANDARD_DEVIATION|27.377||0.411|||||||ANOVA|||||||0.411
91737434|NCT00688467|183368103|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|23.3|STANDARD_DEVIATION|0.306||0.292|||||||ANOVA|||||||0.292
91737435|NCT00688467|183368105|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|-1.7|STANDARD_DEVIATION|16.261||0.927|||||||ANOVA|||||||0.927
91737436|NCT00688467|183368106|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|4.3|STANDARD_DEVIATION|7.398||0.645|||||||ANOVA|||||||0.645
91737437|NCT00387088|183368115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.085|0.118|||ANCOVA|ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.||||0.118|0.085|<0.0001
91737438|NCT03623698|183368136|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-4.0|-1.5|||Wilcoxon (Mann-Whitney)|||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.500|-4.000|<0.001
91737439|NCT03623698|183368136|OTHER|Linear mixed-effects model|Restricted Maximum Likelihood (REML)|-2.88||||0.001|TWO_SIDED|95.0|-4.46|-1.29||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, mechanical ventilation, tracheostomy, gastrostomy, non-ambulant.||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.29|-4.46|0.001
91737440|NCT03623698|183368137|OTHER||Median Difference (Final Values)|-1.0||||0.001|TWO_SIDED|95.0|-1.5|-0.5|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.50|-1.50|0.001
91737441|NCT03623698|183368137|OTHER||Restricted Maximum Likelihood (REML)|-1.02|||<|0.001|TWO_SIDED|95.0|-1.53|-0.52||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, prolonged mechanical ventilation (nasal or tracheostomy), and antibiotic prophylaxis||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.52|-1.53|<0.001
91737442|NCT03623698|183368140|OTHER||Median Difference (Final Values)|-4.5||||0.003|TWO_SIDED|95.0|-5.5|-3.0|||Wilcoxon (Mann-Whitney)|||||-3.00|-5.50|0.003
91737443|NCT03623698|183368141|OTHER||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-2.0|||Wilcoxon (Mann-Whitney)|||||-2.0|-2.5|<0.001
91737444|NCT03623698|183368144|OTHER||Mean Difference (Final Values)|0.17||||0.97|TWO_SIDED|95.0|-0.69|0.76|||Wilcoxon (Mann-Whitney)|||||0.76|-0.69|0.97
91737445|NCT03623698|183368145|OTHER||Mean Difference (Final Values)|-1.47||||0.09|TWO_SIDED|95.0|-3.26|0.34|||Wilcoxon (Mann-Whitney)|||||0.34|-3.26|0.09
91737446|NCT03623698|183368146|OTHER||Mean Difference (Final Values)|-0.08||||0.65|TWO_SIDED|95.0|-0.38|0.38|||Wilcoxon (Mann-Whitney)|||||0.38|-0.38|0.65
91737447|NCT00811954|183368152|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|3.4|||||TWO_SIDED|97.5|-0.7|7.4||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||7.4|-0.7|
91498765|NCT01313767|182867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9574|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.9574
91498766|NCT01313767|182867609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
91498767|NCT01313767|182867609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
91498768|NCT01313767|182867609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.4017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.||||0.4017
91498769|NCT01313767|182867610|SUPERIORITY_OR_OTHER|||||||0.2346|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.2346
91704824|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of discomfort||||>0.05
91704825|NCT03646305|183304381|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on discomfort levels||||>0.05
91704826|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, willingness to engage with target thought were equivalent across time||||<0.001
91704827|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from baseline to post-intervention. Null hypothesis: there would be no difference in willingness scores from baseline to post-intervention||||<0.001
91705689|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|2.7||0.971|TWO_SIDED|95.0|-5.21|5.41||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.41|-5.21|0.971
91705690|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|1.57|STANDARD_ERROR_OF_MEAN|1.32||0.236|TWO_SIDED|95.0|-1.03|4.17||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.17|-1.03|0.236
91705691|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|1.02|STANDARD_ERROR_OF_MEAN|1.29||0.429|TWO_SIDED|95.0|-1.52|3.56||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.56|-1.52|0.429
91705692|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|1.56|STANDARD_ERROR_OF_MEAN|1.36||0.252|TWO_SIDED|95.0|-1.12|4.24||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.24|-1.12|0.252
91498770|NCT01313767|182867611|SUPERIORITY_OR_OTHER|||||||0.9513|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.9513
91498771|NCT01313767|182867612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.8088
91498772|NCT01313767|182867612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3702|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.3702
91498773|NCT01313767|182867612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.1497|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.1497
91704828|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.053|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from post-intervention to follow-up. Null hypothesis: there would be no significant difference in willingness scores from post-intervention to follow-up.||||=0.053
91704829|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal willingness scores||||>0.05
91704830|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal willingness to engage with the target thought||||>0.05
91704831|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in willingness to engage||||>0.05
91704832|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in willingness to engage with the target thought across time.||||>0.05
91704833|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on willingness to engage||||>0.05
91704834|NCT03646305|183304382|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on willingness to engage||||>0.05
91705693|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|1.52|STANDARD_ERROR_OF_MEAN|1.32||0.251|TWO_SIDED|95.0|-1.08|4.11||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.11|-1.08|0.251
91498774|NCT01313767|182867613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.9634|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.9634
91498775|NCT01313767|182867613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.7302|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7302
91704835|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.01|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, avoidance of target thought were equivalent across time||||<0.01
91704836|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from baseline to post-intervention. Null hypothesis: there would be no significant differences in avoidance from baseline to post-intervention||||>0.05
91704837|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||<|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from post-intervention to follow-up. Null hypothesis: there would be no significant differences in avoidance from post-intervention to follow-up.||||<0.05
91704838|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would show equal avoidance of target thought||||>0.05
91704839|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal avoidance of target thought||||>0.05
91704840|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in avoidance of target thought||||>0.05
91498776|NCT01313767|182867613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7715|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7715
91498777|NCT01313767|182867614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9362|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.9362
91498778|NCT01313767|182867614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.7998|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.7998
91498779|NCT01313767|182867614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5436|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.5436
91498780|NCT01313767|182867615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.7014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.7014
91498781|NCT01313767|182867615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8884|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.8884
91737448|NCT00811954|183368152|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|5.6|||||TWO_SIDED|97.5|1.3|9.9||||||Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||9.9|1.3|
91737449|NCT00811954|183368152|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|-2.2|||||TWO_SIDED|97.5|-6.7|2.3||||||Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||2.3|-6.7|
91737450|NCT00811954|183368153|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|12.8|||||TWO_SIDED|97.5|9.4|16.1||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||16.1|9.4|
91737451|NCT00811954|183368153|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|3.6|||||TWO_SIDED|97.5|1.4|5.8||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||5.8|1.4|
91760063|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|||||TWO_SIDED|95.0|-1.51|-0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.60|-1.51|
91704841|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in avoidance of target thought across time.||||>0.05
91704842|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on avoidance of target thought||||>0.05
91704843|NCT03646305|183304383|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on avoidance of target thought||||>0.05
91705694|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.54|STANDARD_ERROR_OF_MEAN|1.27||0.671|TWO_SIDED|95.0|-3.03|1.95||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.95|-3.03|0.671
91705695|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.21|STANDARD_ERROR_OF_MEAN|1.24||0.868|TWO_SIDED|95.0|-2.64|2.23||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.23|-2.64|0.868
91498782|NCT01313767|182867615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.284|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.2840
91498783|NCT01084174|182867622|OTHER|||||||0.003|||||||Regression, Linear|Analyzed by linear regression models using generalized estimating equations to account for repeated measures over time with robust standard errors||||||.003
91498784|NCT01084174|182867623|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
91498785|NCT01084174|182867624|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
91498786|NCT01084174|182867625|OTHER|||||||0.4|||||||Regression, Linear|||||||0.40
91498787|NCT01084174|182867626|OTHER|||||||0.07|||||||Regression, Linear|||||||.07
91498788|NCT01084174|182867627|OTHER|||||||0.007|||||||Regression, Linear|||||||.007
91498789|NCT03103919|182867659|SUPERIORITY||Mean Difference (Final Values)|-4.31|||=|0.134|TWO_SIDED|95.0|-10.04|1.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||1.41|-10.04|=0.134
91498790|NCT03103919|182867660|SUPERIORITY||Mean Difference (Final Values)|0.01|||=|0.982|TWO_SIDED|95.0|-0.44|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.44|=0.982
91498791|NCT03103919|182867661|SUPERIORITY||Mean Difference (Final Values)|-0.18|||=|0.566|TWO_SIDED|95.0|-0.81|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.81|=0.566
91737452|NCT00811954|183368153|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|9.2|||||TWO_SIDED|97.5|5.5|12.9||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.||12.9|5.5|
91737453|NCT01247064|183368188|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91737454|NCT01247064|183368189|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
91737455|NCT01247064|183368190|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91737456|NCT01247064|183368191|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
91737457|NCT01247064|183368192|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
91737458|NCT00945659|183368199|SUPERIORITY||Mean Difference (Net)|-0.003|STANDARD_DEVIATION|0.2||0.86|TWO_SIDED|95.0|-0.43|0.36|||Generalized Estimating Equation|||||0.36|-0.43|0.86
91737459|NCT00945659|183368199|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.03|TWO_SIDED|95.0|-0.78|-0.04|||Generalized Estimating Equation|||||-0.04|-0.78|0.03
91737460|NCT00945659|183368200|SUPERIORITY||Mean Difference (Net)|-10.05|STANDARD_DEVIATION|4.72||0.03|TWO_SIDED|95.0|-19.3|-0.81|||Generalized Estimating Equation|||||-0.81|-19.30|0.03
91737461|NCT00945659|183368200|SUPERIORITY||Mean Difference (Net)|-0.82|STANDARD_DEVIATION|5.47||0.88|TWO_SIDED|95.0|-11.54|9.9|||Generalized Estimating Equation|||||9.9|-11.54|0.88
91737462|NCT00945659|183368201|SUPERIORITY||Generalized Estimating Equation|-3.45|STANDARD_DEVIATION|4.98||0.49|TWO_SIDED|95.0|-13.21|6.32|||Generalized Estimating Equation|||||6.32|-13.21|0.49
91737463|NCT00945659|183368201|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_DEVIATION|5.76||0.66|TWO_SIDED|95.0|||||Generalized Estimating Equation|||||||0.66
91737464|NCT00945659|183368202|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|0.86||0.64|TWO_SIDED|95.0|-1.29|2.08|||Generalized Estimating Equation|||||2.08|-1.29|0.64
91737465|NCT00945659|183368202|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.92||0.65|TWO_SIDED|95.0|-2.22|1.39|||Generalized Estimating Equation|||||1.39|-2.22|0.65
91737466|NCT00945659|183368203|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_DEVIATION|63.4||0.99|TWO_SIDED|95.0|-123.56|124.97|||Generalized Estimating Equation|||||124.97|-123.56|0.99
91737467|NCT00945659|183368203|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_DEVIATION|13.81||0.93|TWO_SIDED|95.0|-28.26|25.83|||Generalized Estimating Equation|||||25.83|-28.26|0.93
91737468|NCT00945659|183368204|SUPERIORITY||Mean Difference (Net)|1.17|STANDARD_DEVIATION|1.47||0.43|TWO_SIDED|95.0|-1.7|4.04|||Generalized Estimating Equation|||||4.04|-1.70|0.43
91737469|NCT00945659|183368204|SUPERIORITY||Mean Difference (Net)|-2.59|STANDARD_DEVIATION|1.87||0.08|TWO_SIDED|95.0|-5.5|0.32|||Generalized Estimating Equation|||||0.32|-5.50|0.08
91737470|NCT00945659|183368205|SUPERIORITY||Mean Difference (Net)|1.32|STANDARD_DEVIATION|1.66||0.43|TWO_SIDED|95.0|-1.94|4.56|||Generalized Estimating Equation|||||4.56|-1.94|0.43
91737471|NCT00945659|183368205|SUPERIORITY||Mean Difference (Net)|-3.71|STANDARD_DEVIATION|1.36||0.007|TWO_SIDED|95.0|-6.38|-1.04|||Generalized Estimating Equation|||||-1.04|-6.38|.007
91737472|NCT00945659|183368206|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.23||0.75|TWO_SIDED|95.0|-2.02|2.79|||Generalized Estimating Equation|||||2.79|-2.02|0.75
91737473|NCT00945659|183368206|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_DEVIATION|1.38||0.78|TWO_SIDED|95.0|-3.09|2.32|||Generalized Estimating Equation|||||2.32|-3.09|0.78
91737474|NCT00945659|183368207|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_DEVIATION|1.31||0.58|TWO_SIDED|95.0|-1.86|3.29|||Generalized Estimating Equation|||||3.29|-1.86|0.58
91737475|NCT00945659|183368207|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_DEVIATION|1.14||0.41|TWO_SIDED|95.0|-3.17|1.3|||Generalized Estimating Equation|||||1.3|-3.17|0.41
91737476|NCT00945659|183368208|SUPERIORITY||Mean Difference (Net)|1.95|STANDARD_DEVIATION|2.66||0.46|TWO_SIDED|95.0|-3.26|7.15|||Generalized Estimating Equation|||||7.15|-3.26|0.46
91737477|NCT00945659|183368208|SUPERIORITY||Mean Difference (Net)|-3.01|STANDARD_DEVIATION|2.54||0.24|TWO_SIDED|95.0|-7.99|1.96|||Generalized Estimating Equation|||||1.96|-7.99|0.24
91737478|NCT00945659|183368209|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_DEVIATION|3.37||0.93|TWO_SIDED|95.0|-6.33|6.91|||Generalized Estimating Equation|||||6.91|-6.33|0.93
91737479|NCT00945659|183368209|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_DEVIATION|2.95||0.45|TWO_SIDED|95.0|-8.01|3.57|||Generalized Estimating Equation|||||3.57|-8.01|0.45
91737480|NCT00945659|183368210|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|3.26||0.81|TWO_SIDED|95.0|-7.15|5.62|||Generalized Estimating Equestion|||||5.62|-7.15|0.81
91737481|NCT00945659|183368210|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.63||0.72|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.72
91498792|NCT03103919|182867662|SUPERIORITY||Mean Difference (Final Values)|-0.07|||=|0.72|TWO_SIDED|95.0|-0.5|0.35|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.35|-0.50|=0.720
91498793|NCT03103919|182867663|SUPERIORITY||Mean Difference (Final Values)|0.15|||=|0.443|TWO_SIDED|95.0|-0.24|0.53|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.53|-0.24|=0.443
91705696|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|1.25||0.938|TWO_SIDED|95.0|-2.37|2.57||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.57|-2.37|0.938
91705697|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.29|STANDARD_ERROR_OF_MEAN|1.22||0.813|TWO_SIDED|95.0|-2.69|2.12||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.12|-2.69|0.813
91705698|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|9.55|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.1|15.99||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||15.99|3.10|0.004
91705699|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|2.69|STANDARD_ERROR_OF_MEAN|3.21||0.403|TWO_SIDED|95.0|-3.63|9.0||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||9.00|-3.63|0.403
91705700|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|3.18|STANDARD_ERROR_OF_MEAN|3.82||0.406|TWO_SIDED|95.0|-4.34|10.69||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.69|-4.34|0.406
91705701|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.79|STANDARD_ERROR_OF_MEAN|3.72||0.832|TWO_SIDED|95.0|-8.11|6.53||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.53|-8.11|0.832
91705702|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|1.9|STANDARD_ERROR_OF_MEAN|1.47||0.197|TWO_SIDED|95.0|-0.99|4.79||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.79|-0.99|0.197
91705703|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|2.89|STANDARD_ERROR_OF_MEAN|1.44||0.045|TWO_SIDED|95.0|0.06|5.72||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.72|0.06|0.045
91705704|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.53|STANDARD_ERROR_OF_MEAN|1.34||0.692|TWO_SIDED|95.0|-3.16|2.1||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.10|-3.16|0.692
91705705|NCT01026818|183305810|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.09|STANDARD_ERROR_OF_MEAN|1.3||0.943|TWO_SIDED|95.0|-2.65|2.46||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.46|-2.65|0.943
91705706|NCT01026818|183305811|SUPERIORITY_OR_OTHER||LS Mean Differences|4.2|STANDARD_ERROR_OF_MEAN|1.89||0.028|TWO_SIDED|95.0|0.47|7.93||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||7.93|0.47|0.028
91705707|NCT01026818|183305811|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.53|STANDARD_ERROR_OF_MEAN|1.87||0.413|TWO_SIDED|95.0|-5.2|2.14||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||2.14|-5.20|0.413
91705708|NCT01026818|183305811|SUPERIORITY_OR_OTHER||LS Mean Differences|2.37|STANDARD_ERROR_OF_MEAN|1.49||0.112|TWO_SIDED|95.0|-0.55|5.3||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||5.30|-0.55|0.112
91705709|NCT01026818|183305811|SUPERIORITY_OR_OTHER||LS Mean Differences|3.16|STANDARD_ERROR_OF_MEAN|1.46||0.031|TWO_SIDED|95.0|0.29|6.03||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||6.03|0.29|0.031
91705710|NCT00424593|183305819|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.|Repeated Measures Analysis|||||||0.004
91705711|NCT00424593|183305820|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||||||0.014
91705712|NCT00424593|183305821|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for 13 Week Change from Baseline.|ANCOVA|||||||0.009
91705713|NCT00424593|183305822|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Average Pain Score Change from Baseline.|ANCOVA|||||||0.002
91705714|NCT00424593|183305822|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Worst Pain Score Change from Baseline.|ANCOVA|||||||0.014
91705715|NCT00424593|183305822|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Night Pain Score Change from Baseline.|ANCOVA|||||||0.007
91705716|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Worst Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.011
91705717|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Least Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.001
91705718|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Average Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.019
91705719|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pain Right Now Score Week 13 Change from Baseline.|ANCOVA|||||||0.002
91737482|NCT00945659|183368211|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.6||0.71|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.71
91737483|NCT00945659|183368211|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|2.85||0.68|TWO_SIDED|95.0|-6.74|4.43|||Generalized Estimating Equation|||||4.43|-6.74|0.68
91498794|NCT03103919|182867664|SUPERIORITY||Mean Difference (Final Values)|-0.09|||=|0.777|TWO_SIDED|95.0|-0.75|0.57|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.57|-0.75|=0.777
91705720|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for General Activity Week 13 Change from Baseline.|ANCOVA|||||||0.068
91705721|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Mood Week 13 Change from Baseline.|ANCOVA|||||||0.009
91705722|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Walking Ability Week 13 Change from Baseline.|ANCOVA|||||||0.006
91705723|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Normal Work Week 13 Change from Baseline.|ANCOVA|||||||0.024
91705724|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Relations With People Week 13 Change from Baseline.|ANCOVA|||||||0.005
91705725|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Sleep Week 13 Change from Baseline.|ANCOVA|||||||0.051
91705726|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Enjoyment of Life Week 13 Change from Baseline.|ANCOVA|||||||0.013
91705727|NCT00424593|183305823|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Average Interference Week 13 Change from Baseline.|ANCOVA|||||||0.005
91705728|NCT00424593|183305824|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.092
91705729|NCT00424593|183305825|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.060
91705730|NCT00424593|183305826|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
91705731|NCT00424593|183305827|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.329
91705732|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Mental Component Summary Change from Baseline.|ANCOVA|||||||0.051
91705733|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||P-value for Physical Component Summary Change from Baseline.|ANCOVA|||||||0.220
91705734|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Bodily Pain Change from Baseline.|ANCOVA|||||||0.038
91705735|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for General Health Change from Baseline.|ANCOVA|||||||0.041
91705736|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Mental Health Change from Baseline.|ANCOVA|||||||0.093
91705737|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for Physical Functioning Change from Baseline.|ANCOVA|||||||0.210
91705738|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Role-Emotional Change from Baseline.|ANCOVA|||||||0.170
91705739|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for Role-Physical Change from Baseline.|ANCOVA|||||||0.306
91705740|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Social Functioning Change from Baseline.|ANCOVA|||||||0.053
91705741|NCT00424593|183305828|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value for Vitality Change from Baseline.|ANCOVA|||||||0.040
91705742|NCT00424593|183305829|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.117
91705743|NCT00424593|183305830|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value for Absenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.063
91705744|NCT00424593|183305830|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||P-value for Presenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.452
91705745|NCT00424593|183305830|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Work Productivity Loss Week 13 Change from Baseline.|ANCOVA|||||||0.736
91705746|NCT00424593|183305830|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Work Activity Impairment Week 13 Change from Baseline.|ANCOVA|||||||0.002
91705747|NCT00424593|183305831|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.177
91705748|NCT00424593|183305832|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Anxiety Subscale Change from Baseline.|ANCOVA|||||||0.122
91705749|NCT00424593|183305832|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||P-value for Depression Subscale Change from Baseline.|ANCOVA|||||||0.262
91705750|NCT00424593|183305833|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.046
91705751|NCT00424593|183305834|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.008
91705752|NCT00424593|183305835|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.028
91705753|NCT00424593|183305836|SUPERIORITY_OR_OTHER|||||||0.764||95.0||||P-value for SBP Week 13 Change from Baseline.|ANOVA|||||||0.764
91705754|NCT00424593|183305836|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for DBP Week 13 Change from Baseline.|ANOVA|||||||0.093
91705755|NCT00424593|183305837|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.008
91705756|NCT00560703|183305856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis||||||0.578||95.0|||||ANCOVA|||||||0.578
91705757|NCT00560703|183305857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293||95.0|||||ANCOVA|||It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.||||0.293
91705758|NCT02095197|183305858|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
91705759|NCT02095197|183305859|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
91705760|NCT02095197|183305860|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.30
91705761|NCT02095197|183305861|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
91498795|NCT03103919|182867665|SUPERIORITY||Mean Difference (Final Values)|-0.01|||=|0.947|TWO_SIDED|95.0|-0.33|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.33|=0.947
91737484|NCT00565409|183368222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.2|9.0||P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region.|Cochran-Mantel-Haenszel|Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis.||Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified.||9.0|3.2|<0.0001
91737485|NCT00565409|183368222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.3805|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||2.0|0.7|0.3805
91737486|NCT00565409|183368222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||7.6|3.0|<0.0001
91737487|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11||||0.0853|TWO_SIDED|95.0|0.5|21.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||21.4|0.5|0.0853
91498796|NCT03103919|182867666|SUPERIORITY||Mean Difference (Final Values)|-0.27|||=|0.306|TWO_SIDED|95.0|-0.79|0.26|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.26|-0.79|=0.306
91498797|NCT03103919|182867667|SUPERIORITY||Mean Difference (Final Values)|0.03|||=|0.819|TWO_SIDED|95.0|-0.25|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.25|=0.819
91737488|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8491|TWO_SIDED|95.0|0.2|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||4.8|0.2|0.8491
91737489|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97||||0.1278|TWO_SIDED|95.0|0.4|42.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||42.5|0.4|0.1278
91737490|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||6.4|2.1|<0.0001
91737491|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.3027|TWO_SIDED|95.0|0.8|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||2.7|0.8|0.3027
91737492|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.0001|TWO_SIDED|95.0|1.5|4.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||4.2|1.5|<0.0001
91737493|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55|||<|0.0001|TWO_SIDED|95.0|2.7|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||7.6|2.7|<0.0001
91737494|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5871|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||2.1|0.7|0.5871
91737495|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.3|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||6.1|2.3|<0.0001
91737496|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.52|||<|0.0001|TWO_SIDED|95.0|3.9|11.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||11.0|3.9|<0.0001
91737497|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6716|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||2.0|0.6|0.6716
91498798|NCT03103919|182867668|SUPERIORITY||Mean Difference (Final Values)|0.07|||=|0.663|TWO_SIDED|95.0|-0.26|0.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.41|-0.26|=0.663
91498799|NCT03103919|182867669|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.197|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.11|-0.51|=0.197
91498800|NCT03103919|182867672|SUPERIORITY||Odds Ratio (OR)|1.14|||=|0.876|TWO_SIDED|95.0|0.23|5.66||P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.|Regression, Logistic||Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.|||5.66|0.23|=0.876
91498801|NCT01124422|182867674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|STANDARD_ERROR_OF_MEAN|20.58||0.181|TWO_SIDED|95.0|-68.2|13.0||ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value|ANCOVA|||||13.0|-68.2|0.181
91737498|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.4|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||8.6|3.4|<0.0001
91737499|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.0001|TWO_SIDED|95.0|2.8|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.6|2.8|<0.0001
91737500|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.9399|TWO_SIDED|95.0|0.5|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||1.5|0.5|0.9399
91737501|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|95.0|3.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.7|3.0|<0.0001
91737502|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.25|||<|0.0001|TWO_SIDED|95.0|3.7|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||10.5|3.7|<0.0001
91737503|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.6692|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||1.9|0.6|0.6692
91737504|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||<|0.0001|TWO_SIDED|95.0|3.4|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||8.7|3.4|<0.0001
91737505|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.4|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||9.8|3.4|<0.0001
91737506|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4326|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||2.1|0.7|0.4326
91737507|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12|||<|0.0001|TWO_SIDED|95.0|3.2|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||8.2|3.2|<0.0001
91737508|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.8|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.8|2.8|<0.0001
91737509|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.6064|TWO_SIDED|95.0|0.6|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||1.8|0.6|0.6064
91737510|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|3.0|7.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.4|3.0|<0.0001
91737511|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.4626|TWO_SIDED|95.0|0.5|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.5|0.4626
91737512|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.2886|TWO_SIDED|95.0|0.6|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.6|0.2886
91737513|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.7779|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||1.9|0.4|0.7779
91737514|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.8|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||4.7|1.8|<0.0001
91498802|NCT02959944|182867696|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
91498803|NCT02959944|182867697|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
91498804|NCT02959944|182867698|SUPERIORITY|||||||0.324||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.324
91498805|NCT02959944|182867699|SUPERIORITY|||||||0.281||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.281
91737515|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2091|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||2.0|0.8|0.2091
91737516|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.5|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||3.6|1.5|<0.0001
91737517|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.1|5.2||p-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||5.2|2.1|<0.0001
91737518|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5351|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||1.7|0.7|0.5351
91737519|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.0001|TWO_SIDED|95.0|2.0|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||4.8|2.0|<0.0001
91737520|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.0001|TWO_SIDED|95.0|2.6|6.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||6.5|2.6|<0.0001
91737521|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.4574|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||1.3|0.5|0.4574
91737522|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.2|8.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||8.0|3.2|<0.0001
91737523|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.6|2.7|<0.0001
91737524|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5229|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||1.8|0.7|0.5229
91737525|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.0|2.5|<0.0001
91498806|NCT02959944|182867700|SUPERIORITY|||||||0.275||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.275
91737526|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.3|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||8.6|3.3|<0.0001
91737527|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6464|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||1.8|0.7|0.6464
91737528|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.79|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||7.6|3.0|<0.0001
91737529|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.1|7.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||7.9|3.1|<0.0001
91737530|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.5499|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||1.7|0.7|0.5499
91737531|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.0001|TWO_SIDED|95.0|2.6|6.4|||Cochran-Mantel-Haenszel|||Week 80 Remission||6.4|2.6|<0.0001
91737532|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.8|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||7.0|2.8|<0.0001
91737533|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.1109|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||1.9|0.8|0.1109
91498807|NCT02959944|182867701|SUPERIORITY|||||||0.216||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.216
91498808|NCT02959944|182867702|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
91498809|NCT02959944|182867703|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
91530968|NCT03226457|182938087|OTHER|Details of the power calculation are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739|||||=|0.005||||||(calculated)|ANCOVA|||"Details on the statistical analysis are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739~Analyses were performed on the primary and secondary measures comparing empagliflozin versus placebo and assessed by 2-way analysis of covariance correcting for treatment order, baseline value, and any percentage change in furosemide dose at the visit. Data for continuous outcome measures were assessed for normality before analysis."||||= 0.005
91737534|NCT00565409|183368224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||6.0|2.5|<0.0001
91737535|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
91737536|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9344|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||0.2|-0.2|0.9344
91737537|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
91737538|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.0|<0.0001
91737539|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6173|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||0.2|-0.1|0.6173
91737540|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.1|<0.0001
91737541|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.7|-1.1|<0.0001
91737542|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.5136|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||0.3|-0.1|0.5136
91737543|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.8|-1.2|<0.0001
91737544|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
91737545|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.4868|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||0.3|-0.1|0.4868
91737546|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
91737547|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.3|<0.0001
91498810|NCT02959944|182867704|SUPERIORITY||Difference in Rates|0.124||||0.0659|TWO_SIDED|95.0|-0.007|0.256||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.256|-0.007|0.0659
91530969|NCT00594932|182938112|SUPERIORITY_OR_OTHER_LEGACY||superiority|4.0|||=|0.041||||||This was the primary endpoint therefore no adjustment for multiple comparisons was necessary|Fisher Exact|||this is a categorical assessment. Prespecified. Fishers exact test. Significant is calculated as \< 0.05||||=0.041
91704844|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, cognitive delusion were equivalent across time||||>0.05
91704845|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of cognitive defusion||||>0.05
91704846|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of cognitive defusion||||>0.05
91704847|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of cognitive defusion||||>0.05
91704848|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of cognitive defusion across time.||||>0.05
91704849|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of cognitive defusion||||>0.05
91705762|NCT04278924|183305871|SUPERIORITY||Risk Difference (RD)|43.59|||=|0.056|TWO_SIDED|95.0|0.81|73.35|||Barnard's test||95% confidence interval (CI) of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.35|0.81|=0.056
91498811|NCT02959944|182867705|SUPERIORITY||Difference in Rates|0.125||||0.0708|TWO_SIDED|95.0|-0.01|0.261||P-value is computed using non-stratified Chi-Square test.|Chi-squared|||||0.261|-0.010|0.0708
91498812|NCT02959944|182867706|SUPERIORITY||Difference in Rates|-0.059||||0.4064|TWO_SIDED|95.0|-0.199|0.08||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.080|-0.199|0.4064
91530970|NCT05199233|182938126|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
91530971|NCT05199233|182938127|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
91737548|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7847|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||0.2|-0.2|0.7847
91737549|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.2|<0.0001
91737550|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
91737551|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.981|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||0.2|-0.2|0.9810
91737552|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
91737553|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.8|-1.3|<0.0001
91737554|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3562|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||0.1|-0.3|0.3562
91737555|NCT00565409|183368226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.7|-1.2|<0.0001
91737556|NCT00565409|183368227|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
91498813|NCT02959944|182867707|SUPERIORITY||Difference in Rates|-0.049||||0.4955|TWO_SIDED|95.0|-0.188|0.091||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.091|-0.188|0.4955
91737557|NCT00565409|183368227|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
91498814|NCT02959944|182867708|SUPERIORITY||Hazard Ratio (HR)|0.994|||||TWO_SIDED|95.0|0.507|1.949|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.949|0.507|
91498815|NCT02959944|182867709|SUPERIORITY||Hazard Ratio (HR)|1.061|||||TWO_SIDED|95.0|0.591|1.904|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.904|0.591|
91498816|NCT02959944|182867710|SUPERIORITY||Hazard Ratio (HR)|0.697||||0.101|TWO_SIDED|95.0|0.451|1.076|||Regression, Cox|||||1.076|0.451|0.1010
91737558|NCT00565409|183368227|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||0.8622
91737559|NCT00565409|183368228|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
91737560|NCT00565409|183368228|SUPERIORITY_OR_OTHER|||||||0.9841|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||0.9841
91737561|NCT00565409|183368228|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
91737562|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
91737563|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8015|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.3|0.8015
91737564|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
91737565|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.7|-1.5|<0.0001
91737566|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.8534|TWO_SIDED|95.0|-0.4|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.4|0.8534
91737567|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.6|<0.0001
91737568|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
91737569|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9074|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.4|0.9074
91704850|NCT03646305|183304384|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on levels of cognitive defusion||||>0.05
91704851|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, weight dissatisfaction were equivalent across time.||||<0.001
91704852|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in weight dissatisfaction from baseline to post-intervention. Null hypothesis: there would be no significant differences in weight dissatisfaction from baseline to post-intervention||||<0.001
91704853|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in weight dissatisfaction from post-intervention to follow-up. Null: there would be no differences in weight dissatisfaction from post-intervention to follow-up||||<0.05
91704854|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal weight dissatisfaction||||>0.05
91704855|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal weight dissatisfaction scores||||>0.05
91704856|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in weight dissatisfaction||||>0.05
91705763|NCT04278924|183305871|SUPERIORITY||Risk Difference (RD)|39.42|||=|0.088|TWO_SIDED|95.0|-4.24|71.38|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.38|-4.24|=0.088
91530972|NCT02144519|182938161|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|1.18|3.0|||Mixed Models Analysis|||||3.00|1.18|0.008
91530973|NCT02144519|182938162|SUPERIORITY||Odds Ratio (OR)|3.8||||0.003|TWO_SIDED|95.0|1.45|9.95|||Regression, Logistic|||||9.95|1.45|0.003
91530974|NCT05126459|182938186|SUPERIORITY|||||||0.016||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events during sedation.||||0.016
91737570|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
91737571|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
91737572|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9229|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.4|0.9229
91737573|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
91737574|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
91737575|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9279|TWO_SIDED|95.0|-0.5|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.5|0.9279
91737576|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
91737577|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.1|-2.1|<0.0001
91737578|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7695|TWO_SIDED|95.0|-0.6|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.4|-0.6|0.7695
91737579|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-2.0|<0.0001
91737580|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-2.3|<0.0001
91498817|NCT02959944|182867711|SUPERIORITY||Hazard Ratio (HR)|0.717||||0.1004|TWO_SIDED|95.0|0.482|1.068|||Regression, Cox|||||1.068|0.482|0.1004
91498818|NCT03070782|182867748|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0032|TWO_SIDED|95.0|-46.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-12|-46|0.0032
91737581|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.2182|TWO_SIDED|95.0|-0.8|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.8|0.2182
91737582|NCT00565409|183368232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.9|<0.0001
91737583|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0003|TWO_SIDED|95.0|-1.3|-0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.4|-1.3|0.0003
91737584|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.6088|TWO_SIDED|95.0|-0.3|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.6|-0.3|0.6088
91737585|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.4|<0.0001
91737586|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.4|-2.6|<0.0001
91737587|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.9048|TWO_SIDED|95.0|-0.5|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANOVA|||Week 48||0.6|-0.5|0.9048
91737588|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.5|-2.6|<0.0001
91737589|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.5|-2.6|<0.0001
91737590|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8437|TWO_SIDED|95.0|-0.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.6|0.8437
91737591|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.4|-2.6|<0.0001
91737592|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
91737593|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8587|TWO_SIDED|95.0|-0.6|0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.7|-0.6|0.8587
91737594|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
91737595|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.8|-3.0|<0.0001
91737596|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6323|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.5|-0.8|0.6323
91498819|NCT03070782|182867748|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-41.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-41|-64|<.0001
91737597|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.6|-2.9|<0.0001
91498820|NCT03070782|182867748|SUPERIORITY||Mean Difference in % CFB|-70.0|||<|0.0001|TWO_SIDED|95.0|-77.0|-62.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-62|-77|<.0001
91737598|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.6|-2.9|<0.0001
91737599|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6558|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.5|-0.8|0.6558
91737600|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.5|-2.8|<0.0001
91737601|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.1|<0.0001
91737602|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8688|TWO_SIDED|95.0|-0.7|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.6|-0.7|0.8688
91737603|NCT00565409|183368235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.0|<0.0001
91737604|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
91737605|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9636|TWO_SIDED|95.0|-0.2|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.2|0.9636
91737606|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
91737607|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.4|<0.0001
91737608|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.4605|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.2|0.4605
91737609|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.5|<0.0001
91737610|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.4|<0.0001
91737611|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8404|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.3|-0.3|0.8404
91737612|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.4|<0.0001
91737613|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.4|<0.0001
91498821|NCT03070782|182867748|SUPERIORITY||Mean Difference in % CFB|-56.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-43.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-43|-65|<.0001
91530975|NCT05126459|182938187|SUPERIORITY|||||||0.211||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events at 8 hours after sedation.||||0.211
91530976|NCT05126459|182938188|SUPERIORITY|||||||0.374||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.374
91737614|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.3118|TWO_SIDED|95.0|-0.1|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.1|0.3118
91498822|NCT03070782|182867748|SUPERIORITY||Mean Difference in % CFB|-78.0|||<|0.0001|TWO_SIDED|95.0|-83.0|-72.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-72|-83|<.0001
91530977|NCT05126459|182938189|SUPERIORITY|||||||0.55|||||||ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens.||||0.55
91737615|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.0|-1.6|<0.0001
91737616|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
91737617|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.61|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.2|0.6100
91737618|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.6|<0.0001
91737619|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
91737620|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6552|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.2|-0.4|0.6552
91737621|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
91737622|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.1|-1.8|<0.0001
91704857|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in weight dissatisfaction across time.||||>0.05
91704858|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on weight dissatisfaction||||>0.05
91737623|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4753|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.4|0.4753
91737624|NCT00565409|183368238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.0|-1.6|<0.0001
91737625|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.6|-1.2|<0.0001
91737626|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.7427|TWO_SIDED|95.0|-0.4|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.4|0.7427
91530978|NCT05126459|182938190|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens 8 hours after sedation.||||0.16
91737627|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
91737628|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.1|-1.7|<0.0001
91737629|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3129|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.2|-0.5|0.3129
91737630|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.6|<0.0001
91737631|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.6|<0.0001
91737632|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4645|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.2|-0.5|0.4645
91737633|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.5|<0.0001
91737634|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.9|-1.7|<0.0001
91737635|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.3793|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.2|-0.5|0.3793
91737636|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.5|<0.0001
91737637|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.2|-2.0|<0.0001
91498823|NCT03070782|182867752|SUPERIORITY||Mean Difference in % CFB|-6.0||||0.4407|TWO_SIDED|95.0|-19.0|9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||9|-19|0.4407
91737638|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0816|TWO_SIDED|95.0|-0.7|0.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.0|-0.7|0.0816
91498824|NCT03070782|182867752|SUPERIORITY||Mean Difference in % CFB|-25.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-13.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-13|-35|<.0001
91737639|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
91737640|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.2|-1.9|<0.0001
91737641|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0256|TWO_SIDED|95.0|-0.8|-0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.1|-0.8|0.0256
91737642|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.8|-1.5|<0.0001
91737643|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-1.9|<0.0001
91498825|NCT03070782|182867752|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0368|TWO_SIDED|95.0|-26.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-26|0.0368
91530979|NCT05126459|182938191|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens at 24 hours after sedation.||||0.012
91704859|NCT03646305|183304385|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on weight dissatisfaction||||>0.05
91704860|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appearance dissatisfaction were equivalent across time.||||<0.001
91704861|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from baseline to post-intervention||||>0.05
91704862|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from post-intervention to follow-up.||||<0.001
91705764|NCT04278924|183305871|SUPERIORITY||Risk Difference (RD)|67.83|||=|0.001|TWO_SIDED|95.0|29.21|87.29|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||87.29|29.21|=0.001
91705765|NCT04278924|183305872|SUPERIORITY||Risk Difference (RD)|55.56|||=|0.001|TWO_SIDED|95.0|25.11|81.51|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||81.51|25.11|=0.001
91705766|NCT04278924|183305872|SUPERIORITY||Risk Difference (RD)|50.0|||=|0.004|TWO_SIDED|95.0|19.63|78.95|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.95|19.63|=0.004
91705767|NCT04278924|183305872|SUPERIORITY||Risk Difference (RD)|81.82|||<|0.001|TWO_SIDED|95.0|51.24|94.99|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||94.99|51.24|<0.001
91705768|NCT04278924|183305873|SUPERIORITY||Risk Difference (RD)|35.9|||=|0.12|TWO_SIDED|95.0|-7.22|67.75|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||67.75|-7.22|=0.120
91705769|NCT04278924|183305873|SUPERIORITY||Risk Difference (RD)|44.23|||=|0.06|TWO_SIDED|95.0|-0.83|73.77|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.77|-0.83|=0.060
91705770|NCT04278924|183305873|SUPERIORITY||Risk Difference (RD)|60.14|||=|0.003|TWO_SIDED|95.0|21.33|82.42|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||82.42|21.33|=0.003
91498826|NCT03070782|182867752|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0216|TWO_SIDED|95.0|-28.0|-3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-3|-28|0.0216
91530980|NCT04675242|182938269|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.4434|TWO_SIDED|95.0|-11.5|15.3|||Fisher Exact|||Difference in the proportion of study eyes with complete cure||15.3|-11.5|0.4434
91530981|NCT04675242|182938270|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.2105|TWO_SIDED|95.0|-9.5|2.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the change from baseline between treatment groups||2.1|-9.5|0.2105
91705771|NCT04278924|183305874|SUPERIORITY||Risk Difference (RD)|40.0|||=|0.187|TWO_SIDED|95.0|-16.28|78.17|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.17|-16.28|=0.187
91705772|NCT04278924|183305874|SUPERIORITY||Risk Difference (RD)|25.0|||=|0.315|TWO_SIDED|95.0|-28.85|71.78|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.78|-28.85|=0.315
91705773|NCT04278924|183305874|SUPERIORITY||Risk Difference (RD)|100.0|||=|0.004|TWO_SIDED|95.0|35.12|100.0|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||100.00|35.12|=0.004
91705774|NCT04847232|183305875|OTHER|Test of HR = 1|Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox||SZC relative to Placebo|||1.26|0.76|0.867
91737644|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.1158|TWO_SIDED|95.0|-0.7|0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.1|-0.7|0.1158
91498827|NCT03070782|182867752|SUPERIORITY||Mean Difference in % CFB|-22.0||||0.0012|TWO_SIDED|95.0|-33.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-33|0.0012
91498828|NCT03070782|182867753|SUPERIORITY||Odds Ratio (OR)|4.98||||0.0286|TWO_SIDED|95.0|1.2|21.0|||Regression, Logistic|||||21.0|1.2|0.0286
91498829|NCT03070782|182867753|SUPERIORITY||Odds Ratio (OR)|31.07|||<|0.0001|TWO_SIDED|95.0|7.3|131.4|||Regression, Logistic|||||131.4|7.3|<.0001
91498830|NCT03070782|182867753|SUPERIORITY||Odds Ratio (OR)|122.81|||<|0.0001|TWO_SIDED|95.0|24.0|627.4|||Regression, Logistic|||||627.4|24.0|<.0001
91498831|NCT03070782|182867753|SUPERIORITY||Odds Ratio (OR)|43.78|||<|0.0001|TWO_SIDED|95.0|9.8|195.0|||Regression, Logistic|||||195.0|9.8|<.0001
91498832|NCT03070782|182867753|SUPERIORITY||Odds Ratio (OR)|1124.56|||<|0.0001|TWO_SIDED|95.0|109.3|11571.0|||Regression, Logistic|||||11571|109.3|<.0001
91498833|NCT03070782|182867754|SUPERIORITY||Odds Ratio (OR)|7.34||||0.2007|TWO_SIDED|95.0|0.3|155.3|||Regression, Logistic|||||155.3|0.3|0.2007
91498834|NCT03070782|182867754|SUPERIORITY||Odds Ratio (OR)|27.92||||0.0258|TWO_SIDED|95.0|1.5|521.5|||Regression, Logistic|||||521.5|1.5|0.0258
91498835|NCT03070782|182867754|SUPERIORITY||Odds Ratio (OR)|113.92||||0.0014|TWO_SIDED|95.0|6.2|2098.5|||Regression, Logistic|||||2098.5|6.2|0.0014
91498836|NCT03070782|182867754|SUPERIORITY||Odds Ratio (OR)|59.85||||0.0063|TWO_SIDED|95.0|3.2|1128.0|||Regression, Logistic|||||1128.0|3.2|0.0063
91498837|NCT03070782|182867754|SUPERIORITY||Odds Ratio (OR)|347.02|||<|0.0001|TWO_SIDED|95.0|18.3|6597.9|||Regression, Logistic|||||6597.9|18.3|<.0001
91498838|NCT03070782|182867755|SUPERIORITY||Mean Difference in % CFB|-4.0||||0.4022|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||5|-12|0.4022
91498839|NCT03070782|182867755|SUPERIORITY||Mean Difference in % CFB|-16.0|||<|0.0001|TWO_SIDED|95.0|-23.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-23|<.0001
91498840|NCT03070782|182867755|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0323|TWO_SIDED|95.0|-17.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-17|0.0323
91498841|NCT03070782|182867755|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0157|TWO_SIDED|95.0|-18.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-18|0.0157
91498842|NCT03070782|182867755|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-24.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-24|<.0001
91498843|NCT03070782|182867756|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.4956|TWO_SIDED|95.0|-32.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||21|-32|0.4956
91498844|NCT03070782|182867756|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0027|TWO_SIDED|95.0|-52.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-14|-52|0.0027
91498845|NCT03070782|182867756|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-38.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-38|-65|<.0001
91498846|NCT03070782|182867756|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0114|TWO_SIDED|95.0|-48.0|-8.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-8|-48|0.0114
91498847|NCT03070782|182867756|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-49.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-49|-72|<.0001
91498848|NCT03070782|182867757|SUPERIORITY||Mean Difference in % CFB|-45.0||||0.002|TWO_SIDED|95.0|-62.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-19|-62|0.0020
91498849|NCT03070782|182867757|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-74.0|-46.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-46|-74|<.0001
91498850|NCT03070782|182867757|SUPERIORITY||Mean Difference in % CFB|-82.0|||<|0.0001|TWO_SIDED|95.0|-87.0|-73.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-73|-87|<.0001
91498851|NCT03070782|182867757|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-78.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-78|<.0001
91498852|NCT03070782|182867757|SUPERIORITY||Mean Difference in % CFB|-89.0|||<|0.0001|TWO_SIDED|95.0|-93.0|-84.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-84|-93|<.0001
91530982|NCT04675242|182938271|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5936|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the mean change from baseline||0.1|-0.2|0.5936
91705775|NCT04847232|183305876|OTHER|Test of OR = 1|Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.64|4.26|||Regression, Logistic||SZC relative to Placebo|||4.26|2.64|<.0001
91705776|NCT04847232|183305877|OTHER|Test of HR = 1|Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.8|1.56|||Regression, Cox||SZC relative to Placebo|||1.56|0.80|0.510
91737645|NCT00565409|183368241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.6|<0.0001
91704863|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal appearance dissatisfaction||||>0.05
91705777|NCT06010732|183305910|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-5.5|5.4||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||5.4|-5.5|0.986
91498853|NCT01830699|182867761|NON_INFERIORITY_OR_EQUIVALENCE|For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.|Mean Difference (Final Values)|-23.9||||0.004|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.004
91498854|NCT01830699|182867762|NON_INFERIORITY_OR_EQUIVALENCE|See details above regarding effect size, power, etc.||||||0.044|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.044
91498855|NCT02288559|182867769|SUPERIORITY||Difference in Adjusted Means|0.435||||0.0428|TWO_SIDED|80.0|0.162|0.707|||Mixed-Effect Model Repeated Measures|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.707|0.162|0.0428
91498856|NCT02288559|182867769|SUPERIORITY||Difference in Adjusted Means|-0.21||||0.3361|TWO_SIDED|80.0|-0.491|0.071|||MMRM|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.071|-0.491|0.3361
91498857|NCT02135146|182867784|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
91498858|NCT02135146|182867784|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91498859|NCT00810407|182867795|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was diagnosis. The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events."||||<0.001
91498860|NCT00810407|182867796|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was gender. The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events."||||<0.001
91498861|NCT00810407|182867797|SUPERIORITY_OR_OTHER|||||||0.587|||||||Fisher Exact|||"The factor tested was age. The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events."||||0.587
91498862|NCT00810407|182867797|SUPERIORITY_OR_OTHER|||||||0.428|||||||Cochran-Armitage (EXACT)|||"The factor tested was age. The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline."||||0.428
91498863|NCT02320149|182867822|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.7|-3.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-3.6|-6.7|< 0.0001
91498864|NCT02320149|182867823|SUPERIORITY||Treatment Rate Difference|11.05|||<|0.0001|TWO_SIDED|95.0|6.39|15.72||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||15.72|6.39|< 0.0001
91498865|NCT02320149|182867824|SUPERIORITY||Least Squares Mean Difference|-16.7|||<|0.0001|TWO_SIDED|95.0|-21.9|-11.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-11.6|-21.9|< 0.0001
91498866|NCT02320149|182867825|SUPERIORITY||Least Squares Mean Difference|-12.5|||<|0.0001||95.0|-16.9|-8.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-8.0|-16.9|< 0.0001
91498867|NCT02320149|182867826|SUPERIORITY||Least Squares Mean Difference|-13.3|||<|0.0001|TWO_SIDED|95.0|-17.5|-9.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-9.1|-17.5|< 0.0001
91498868|NCT02320149|182867827|SUPERIORITY||Least Squares Mean Difference|-7.2||||0.0003|TWO_SIDED|95.0|-11.1|-3.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-3.3|-11.1|0.0003
91498869|NCT02320149|182867828|SUPERIORITY||Least Squares Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.3|< 0.0001
91498870|NCT02320149|182867829|SUPERIORITY||Least Squares Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.9|-5.4|< 0.0001
91737646|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67||||0.0214|TWO_SIDED|95.0|-77.1|-6.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-6.2|-77.1|0.0214
91737647|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.57||||0.5544|TWO_SIDED|95.0|-45.6|24.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||24.5|-45.6|0.5544
91737648|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1||||0.0826|TWO_SIDED|95.0|-66.2|4.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||4.0|-66.2|0.0826
91737649|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-80.05||||0.0001|TWO_SIDED|95.0|-120.3|-39.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-39.8|-120.3|0.0001
91737650|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.18||||0.0344|TWO_SIDED|95.0|-83.2|-3.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-3.2|-83.2|0.0344
91737651|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.87||||0.0721|TWO_SIDED|95.0|-77.1|3.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.3|-77.1|0.0721
91737652|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.19|||<|0.0001|TWO_SIDED|95.0|-128.7|-49.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-49.7|-128.7|<0.0001
91535604|NCT00991276|182949770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.23||0.5569|TWO_SIDED|95.0|-4.49|8.29||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.29|-4.49|0.5569
91737653|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.14||||0.191|TWO_SIDED|95.0|-65.4|13.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||13.1|-65.4|0.1910
91737654|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.05||||0.0018|TWO_SIDED|95.0|-102.5|-23.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-23.6|-102.5|0.0018
91737655|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-84.36||||0.0002|TWO_SIDED|95.0|-129.1|-39.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-39.6|-129.1|0.0002
91737656|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.935|TWO_SIDED|95.0|-46.3|42.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||42.6|-46.3|0.9350
91737657|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-82.52||||0.0003|TWO_SIDED|95.0|-127.2|-37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-37.8|-127.2|0.0003
91737658|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.73|||<|0.0001|TWO_SIDED|95.0|-157.0|-60.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-60.4|-157.0|<0.0001
91737659|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.6764|TWO_SIDED|95.0|-58.2|37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||37.8|-58.2|0.6764
91737660|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-98.53|||<|0.0001|TWO_SIDED|95.0|-146.7|-50.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-50.3|-146.7|<0.0001
91737661|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-115.48|||<|0.0001|TWO_SIDED|95.0|-157.7|-73.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-73.3|-157.7|<0.0001
91737662|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69||||0.5219|TWO_SIDED|95.0|-55.6|28.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||28.3|-55.6|0.5219
91737663|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.8|||<|0.0001|TWO_SIDED|95.0|-144.0|-59.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-59.6|-144.0|<0.0001
91737664|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-71.6||||0.002|TWO_SIDED|95.0|-116.9|-26.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-26.3|-116.9|0.0020
91737665|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3||||0.5917|TWO_SIDED|95.0|-32.7|57.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||57.3|-32.7|0.5917
91737666|NCT00565409|183368244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.91||||0.0003|TWO_SIDED|95.0|-129.2|-38.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-38.7|-129.2|0.0003
91737667|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.79|||<|0.0001|TWO_SIDED|95.0|-11.9|-5.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.7|-11.9|<0.0001
91737668|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.1033|TWO_SIDED|95.0|-5.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.5|-5.6|0.1033
91498871|NCT02320149|182867830|SUPERIORITY||Least Squares Mean Difference|-2.1||||0.0005|TWO_SIDED|95.0|-3.3|-0.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-0.9|-3.3|0.0005
91737669|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|||<|0.0001|TWO_SIDED|95.0|-9.3|-3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-3.1|-9.3|<0.0001
91737670|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.8|-15.4|<0.0001
91737671|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.6802|TWO_SIDED|95.0|-4.0|2.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||2.6|-4.0|0.6802
91737672|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.39|||<|0.0001|TWO_SIDED|95.0|-14.7|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.1|-14.7|<0.0001
91737673|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.6|-15.6|<0.0001
91737674|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.4404|TWO_SIDED|95.0|-4.8|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||2.1|-4.8|0.4404
91737675|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||<|0.0001|TWO_SIDED|95.0|-14.2|-7.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.2|-14.2|<0.0001
91737676|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.83|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-9.4|-16.2|<0.0001
91737677|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4437|TWO_SIDED|95.0|-4.7|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||2.1|-4.7|0.4437
91737678|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.51|||<|0.0001|TWO_SIDED|95.0|-14.9|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.1|-14.9|<0.0001
91737679|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.79|||<|0.0001|TWO_SIDED|95.0|-18.5|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.1|-18.5|<0.0001
91737680|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.096|TWO_SIDED|95.0|-6.8|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.6|-6.8|0.0960
91737681|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.67|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-8.0|-15.4|<0.0001
91737682|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.56|||<|0.0001|TWO_SIDED|95.0|-18.1|-11.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.0|-18.1|<0.0001
91737683|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.2948|TWO_SIDED|95.0|-5.4|1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.6|-5.4|0.2948
91737684|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-9.1|-16.2|<0.0001
91737685|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.0001|TWO_SIDED|95.0|-16.9|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-9.5|-16.9|<0.0001
91737686|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.213|TWO_SIDED|95.0|-6.0|1.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.3|-6.0|0.2130
91737687|NCT00565409|183368247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.83|||<|0.0001|TWO_SIDED|95.0|-14.5|-7.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-7.1|-14.5|<0.0001
91498872|NCT02320149|182867831|SUPERIORITY||Least Squares Mean Difference|-4.3||||0.5786|TWO_SIDED|95.0|-19.4|10.8||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||10.8|-19.4|0.5786
91498873|NCT02320149|182867832|SUPERIORITY||Least Squares Mean Difference|-2.8||||0.6969|TWO_SIDED|95.0|-17.1|11.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||11.4|-17.1|0.6969
91737688|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||<|0.0001|TWO_SIDED|95.0|-11.8|-5.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.3|-11.8|<0.0001
91737689|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8033|TWO_SIDED|95.0|-3.6|2.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||2.8|-3.6|0.8033
91737690|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.14|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-4.9|-11.3|<0.0001
91737691|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.61|||<|0.0001|TWO_SIDED|95.0|-17.2|-10.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-10.0|-17.2|<0.0001
91737692|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.783|TWO_SIDED|95.0|-4.1|3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.1|-4.1|0.7830
91737693|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.11|||<|0.0001|TWO_SIDED|95.0|-16.7|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-9.5|-16.7|<0.0001
91737694|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.9|-16.1|<0.0001
91737695|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.5732|TWO_SIDED|95.0|-4.6|2.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization|ANCOVA|||Week 56||2.5|-4.6|0.5732
91737696|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.1|-7.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.9|-15.1|<0.0001
91737697|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88|||<|0.0001|TWO_SIDED|95.0|-17.6|-10.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-10.2|-17.6|<0.0001
91704864|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal appearance dissatisfaction scores||||>0.05
91737698|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.2972|TWO_SIDED|95.0|-5.6|1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||1.7|-5.6|0.2972
91737699|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.94|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.3|-15.6|<0.0001
91737700|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.4|-11.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.8|-19.4|<0.0001
91737701|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1477|TWO_SIDED|95.0|-6.6|1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||1.0|-6.6|0.1477
91498874|NCT02320149|182867833|SUPERIORITY||Least Squares Mean Difference|3.0||||0.7377|TWO_SIDED|95.0|-14.7|20.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||20.7|-14.7|0.7377
91498875|NCT02320149|182867834|SUPERIORITY||Least Squares Mean Difference|6.4||||0.2861|TWO_SIDED|95.0|-5.3|18.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||18.1|-5.3|0.2861
91498876|NCT02320149|182867835|SUPERIORITY||Least Squares Mean Difference|-3.9||||0.0014|TWO_SIDED|95.0|-6.3|-1.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 12||-1.5|-6.3|0.0014
91498877|NCT02320149|182867836|SUPERIORITY||Least Squares Mean Difference|-3.4||||0.001|TWO_SIDED|95.0|-5.5|-1.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-1.4|-5.5|0.0010
91530983|NCT04707391|182938292|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup A.|Difference in percentage of participants|0.2|||||TWO_SIDED|0.95|-4.38|3.5||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.50|-4.38|
91737702|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85|||<|0.0001|TWO_SIDED|95.0|-16.6|-9.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-9.0|-16.6|<0.0001
91737703|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.87|||<|0.0001|TWO_SIDED|95.0|-18.6|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.1|-18.6|<0.0001
91498878|NCT02320149|182867837|SUPERIORITY||Least Squares Mean Difference|-2.0||||0.0371|TWO_SIDED|95.0|-4.0|-0.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-0.1|-4.0|0.0371
91498879|NCT02320149|182867838|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.3806|TWO_SIDED|95.0|-2.5|1.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||1.0|-2.5|0.3806
91737704|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.1808|TWO_SIDED|95.0|-6.3|1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.2|-6.3|0.1808
91737705|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-8.5|-16.1|<0.0001
91737706|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||<|0.0001|TWO_SIDED|95.0|-18.5|-10.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-10.9|-18.5|<0.0001
91498880|NCT00333866|182867852|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.23||||0.2361|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.||0.15|-0.61|0.2361
91737707|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.2077|TWO_SIDED|95.0|-6.2|1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.4|-6.2|0.2077
91737708|NCT00565409|183368250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.26|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-8.5|-16.1|<0.0001
91737709|NCT00565409|183368251|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
91737710|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8974|TWO_SIDED|95.0|0.5|2.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.5|0.5|0.8974
91737711|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1105|TWO_SIDED|95.0|0.8|3.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||3.7|0.8|0.1105
91737712|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.19|TWO_SIDED|95.0|0.3|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.3|0.1900
91737713|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.3|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.3|<0.0001
91498881|NCT00333866|182867852|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.0132|TWO_SIDED|95.0|-0.94|-0.17|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||-0.17|-0.94|0.0132
91498882|NCT00333866|182867852|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.33||||0.1694|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||0.05|-0.72|0.1694
91737714|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.4032|TWO_SIDED|95.0|0.6|2.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.4|0.6|0.4032
91737715|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.4|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.4|<0.0001
91737716|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001|TWO_SIDED|95.0|2.1|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.1|<0.0001
91737717|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0272|TWO_SIDED|95.0|1.0|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||3.6|1.0|0.0272
91737718|NCT00565409|183368252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.4|4.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.0|1.4|0.0004
91737719|NCT00565409|183368253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
91737720|NCT00565409|183368253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
91737721|NCT00565409|183368253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91737722|NCT00565409|183368253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91737723|NCT00565409|183368253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
91737724|NCT00565409|183368253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
91737725|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29||||0.1718|TWO_SIDED|95.0|0.5|10.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.7|0.5|0.1718
91737726|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8303|TWO_SIDED|95.0|0.2|7.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||7.3|0.2|0.8303
91737727|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.213|TWO_SIDED|95.0|0.5|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.1|0.5|0.2130
91737728|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.1|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||8.2|2.1|<0.0001
91737729|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.4337|TWO_SIDED|95.0|0.3|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.0|0.3|0.4337
91737730|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.14|||<|0.0001|TWO_SIDED|95.0|2.5|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||10.8|2.5|<0.0001
91737731|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.0|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.5|3.0|<0.0001
91737732|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.8973|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.9|0.4|0.8973
91737733|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|2.8|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.1|2.8|<0.0001
91737734|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.4|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||8.1|2.4|<0.0001
91737735|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5708|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.4|0.5708
91737736|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.0|10.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||10.3|3.0|<0.0001
91737737|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.3|12.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||12.0|3.3|<0.0001
91737738|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8842|TWO_SIDED|95.0|0.4|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.4|0.8842
91737739|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.92|||<|0.0001|TWO_SIDED|95.0|3.2|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.8|3.2|<0.0001
91737740|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.0001|TWO_SIDED|95.0|3.8|14.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||14.4|3.8|<0.0001
91737741|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.1608|TWO_SIDED|95.0|0.6|3.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||3.1|0.6|0.1608
91737742|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.92|||<|0.0001|TWO_SIDED|95.0|2.9|8.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.4|2.9|<0.0001
91737743|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|3.4|12.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||12.4|3.4|<0.0001
91737744|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2825|TWO_SIDED|95.0|0.6|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||2.7|0.6|0.2825
91737745|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.7|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|2.7|<0.0001
91737746|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|2.7|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.7|2.7|<0.0001
91737747|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.4471|TWO_SIDED|95.0|0.5|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.1|0.5|0.4471
91737748|NCT00565409|183368254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.0|2.5|<0.0001
91737749|NCT00565409|183368255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
91737750|NCT00565409|183368255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
91737751|NCT00565409|183368255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91737752|NCT00565409|183368255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91737753|NCT00565409|183368255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
91737754|NCT00565409|183368255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
91737755|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6006|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.4|0.6006
91737756|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.4967|TWO_SIDED|95.0|0.6|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.1|0.6|0.4967
91737757|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3648|TWO_SIDED|95.0|0.4|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.5|0.4|0.3648
91737758|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0024|TWO_SIDED|95.0|1.2|3.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.2|1.2|0.0024
91737759|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8308||95.0|0.6|||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.|0.6|0.8308
91737760|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.0008|TWO_SIDED|95.0|1.3|3.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.4|1.3|0.0008
91737761|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25|||<|0.0001|TWO_SIDED|95.0|2.0|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.2|2.0|<0.0001
91737762|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7374|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.8|0.7|0.7374
91737763|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.8|1.9|<0.0001
91737764|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.8|1.9|<0.0001
91737765|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9599|TWO_SIDED|95.0|0.6|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.6|0.9599
91498883|NCT00333866|182867853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0227
91498884|NCT00333866|182867853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0017
91498885|NCT00333866|182867853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0768||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0768
91737766|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.6|1.9|<0.0001
91737767|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.3|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.7|2.3|<0.0001
91737768|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4509|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.8|0.4509
91737769|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.6|1.9|<0.0001
91737770|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.6|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.0|2.6|<0.0001
91737771|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.3037|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.0|0.7|0.3037
91737772|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.0001|TWO_SIDED|95.0|2.1|5.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.1|2.1|<0.0001
91737773|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.7|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.2|2.7|<0.0001
91737774|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6076|TWO_SIDED|95.0|0.7|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.7|0.6076
91737775|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.0|2.4|<0.0001
91737776|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.6|1.8|<0.0001
91737777|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.7837|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.6|0.6|0.7837
91737778|NCT00565409|183368256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.7|2.0|<0.0001
91737779|NCT00565409|183368257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
91737780|NCT00565409|183368257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
91498886|NCT00333866|182867854|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|||<|0.0001|TWO_SIDED|95.0|-1.42|-0.6|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.60|-1.42|<.0001
91737781|NCT00565409|183368257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91737782|NCT00565409|183368257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91737783|NCT00565409|183368257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
91737784|NCT00565409|183368257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
91737785|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5263|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.0|0.7|0.5263
91737786|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1055|TWO_SIDED|95.0|0.9|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|0.9|0.1055
91737787|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4348|TWO_SIDED|95.0|0.5|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.5|0.4348
91737788|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0003|TWO_SIDED|95.0|1.4|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.3|1.4|0.0003
91737789|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5511|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.7|0.7|0.5511
91737790|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0013|TWO_SIDED|95.0|1.3|2.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.9|1.3|0.0013
91737791|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.8|4.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.3|1.8|<0.0001
91737792|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9225|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.5|0.6|0.9225
91737793|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.0001|TWO_SIDED|95.0|1.9|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.5|1.9|<0.0001
91737794|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.6|2.7|<0.0001
91737795|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.2454|TWO_SIDED|95.0|0.9|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.9|0.2454
91737796|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.9|2.0|<0.0001
91498887|NCT00333866|182867854|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78||||0.0002|TWO_SIDED|95.0|-1.2|-0.37|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.37|-1.20|0.0002
91737797|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.0|2.4|<0.0001
91498888|NCT00333866|182867854|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48||||0.0222|TWO_SIDED|95.0|-0.89|-0.07|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.07|-0.89|0.0222
91737798|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4919|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.9|0.8|0.4919
91737799|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.9|2.0|<0.0001
91737800|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.6|3.0|<0.0001
91737801|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0658|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.3|1.0|0.0658
91737802|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||4.7|2.0|<0.0001
91737803|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED|95.0|2.7|6.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.8|2.7|<0.0001
91737804|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.4014|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.4014
91737805|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.0001|TWO_SIDED|95.0|2.3|5.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||5.5|2.3|<0.0001
91737806|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.9|<0.0001
91737807|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.2824|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.2824
91704865|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in appearance dissatisfaction||||>0.05
91737808|NCT00565409|183368258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.5|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.9|2.5|<0.0001
91737809|NCT00565409|183368259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
91737810|NCT00565409|183368259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
91737811|NCT00565409|183368259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91737812|NCT00565409|183368259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91737813|NCT00565409|183368259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
91737814|NCT00565409|183368259|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||week 36||||<0.0001
91737815|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0575|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0575
91737816|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.063|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0630
91737817|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.916|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.7|0.9160
91737818|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0147|TWO_SIDED|95.0|1.0|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.0|0.0147
91737819|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.8675|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.6|0.6|0.8675
91737820|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0174|TWO_SIDED|95.0|1.1|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.1|0.0174
91737821|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|1.9|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.7|1.9|<0.0001
91737822|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4941|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.3|0.5|0.4941
91737823|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.3|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.0|2.3|<0.0001
91737824|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||5.9|2.0|<0.0001
91737825|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8185|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.5|0.6|0.8185
91737826|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.4|2.1|<0.0001
91737827|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.2|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.6|2.2|<0.0001
91737828|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4254|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.8|0.7|0.4254
91737829|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|1.9|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.9|1.9|<0.0001
91498889|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
91498890|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
91737830|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.8|5.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.8|1.8|<0.0001
91737831|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8766|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.7|0.8766
91737832|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||6.4|2.1|<0.0001
91737833|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.0|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.4|2.0|<0.0001
91737834|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.3535|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.3535
91498891|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
91498892|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
91704866|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in appearance dissatisfaction across time.||||>0.05
91704867|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on appearance dissatisfaction||||>0.05
91704868|NCT03646305|183304386|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on appearance dissatisfaction||||>0.05
91704869|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, body state image satisfaction were equivalent across time||||<0.001
91704870|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from baseline to post intervention. Null hypothesis: there would be no significant differences in state body image satisfaction from baseline to post intervention.||||<0.05
91737835|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.0001|TWO_SIDED|95.0|1.9|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.1|1.9|<0.0001
91737836|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.0001|TWO_SIDED|95.0|2.0|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||6.1|2.0|<0.0001
91737837|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.3231|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.3231
91737838|NCT00565409|183368260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|1.9|5.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.6|1.9|<0.0001
91737839|NCT00565409|183368261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
91737840|NCT00565409|183368261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
91737841|NCT00565409|183368261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
91737842|NCT00565409|183368261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
91737843|NCT00565409|183368261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
91737844|NCT00565409|183368261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
91737845|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14||||0.0089|TWO_SIDED|95.0|0.9|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||5.2|0.9|0.0089
91737846|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6932|TWO_SIDED|95.0|0.5|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.7|0.5|0.6932
91737847|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.76||||0.0019|TWO_SIDED|95.0|1.2|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||6.1|1.2|0.0019
91737848|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.0797|TWO_SIDED|95.0|0.6|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.6|0.6|0.0797
91737849|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8103|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.9|0.4|0.8103
91737850|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.0903|TWO_SIDED|95.0|0.8|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||4.5|0.8|0.0903
91737851|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0035|TWO_SIDED|95.0|1.2|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.8|1.2|0.0035
91737852|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.977|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||2.0|0.5|0.9770
91737853|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0036|TWO_SIDED|95.0|1.3|8.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||8.3|1.3|0.0036
91737854|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.0038|TWO_SIDED|95.0|1.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||7.7|1.0|0.0038
91737855|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9055|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.5|0.9055
91737856|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.002|TWO_SIDED|95.0|1.2|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||9.8|1.2|0.0020
91737857|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35||||0.002|TWO_SIDED|95.0|1.3|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||8.8|1.3|0.0020
91737858|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.5763|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.7|0.4|0.5763
91737859|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93||||0.0002|TWO_SIDED|95.0|1.5|10.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.0|1.5|0.0002
91737860|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21||||0.0004|TWO_SIDED|95.0|1.2|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.8|1.2|0.0004
91737861|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.4828|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.4|0.4828
91737862|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|1.4|9.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||9.0|1.4|<0.0001
91737863|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.0002|TWO_SIDED|95.0|1.4|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|1.4|0.0002
91737864|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8553|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.6|0.8553
91737865|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56||||0.0003|TWO_SIDED|95.0|1.5|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||8.7|1.5|0.0003
91704871|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from post intervention to follow-up. Null hypothesis: there would be no significant differences in state body image satisfaction from post-intervention to follow-up.||||<0.001
91704872|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal body state image satisfaction||||>0.05
91704873|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal state body satisfaction scores||||>0.05
91704874|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in state body image satisfaction||||>0.05
91704875|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in state body image satisfaction across time.||||>0.05
91704876|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on state body image satisfaction||||>0.05
91737866|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|1.6|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.6|1.6|<0.0001
91737867|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.5025|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.0|0.6|0.5025
91737868|NCT00565409|183368262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62||||0.0001|TWO_SIDED|95.0|1.6|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.1|1.6|0.0001
91737869|NCT04828707|183368265|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||"The Intent-To-Treat (ITT) dataset was used for primary outcome. To overcome impact of missing data, statistical analysis was conducted using the Last Observation Carried Forward (LOCF) as an imputation method.~The data of each variable collected from the daily diary was normalized to 28 days for every period (weeks 1-4, weeks 5-8, and weeks 9-12).~Participants' data who entered the treatment phase but dropped out during weeks 5-8 were carried forward and analyzed as their data at weeks 9-12."||||<0.05
91737870|NCT04211363|183368315|SUPERIORITY||Odds Ratio (OR)|20.69|||<|0.0001|TWO_SIDED|95.0|7.58|56.48|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data..|IGA Success Odds Ratio||56.48|7.58|<0.0001
91737871|NCT04211363|183368316|SUPERIORITY||Hazard Ratio (HR)|3.867|||<|0.0001|TWO_SIDED|95.0|2.795|5.351|||Log Rank|Unstratified log-rank test|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to PASI-50||5.351|2.795|<0.0001
91737872|NCT04211363|183368317|SUPERIORITY||Odds Ratio (OR)|12.0|||<|0.0001|TWO_SIDED|95.0|5.15|27.93|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||27.93|5.15|<0.0001
91737873|NCT04211363|183368318|SUPERIORITY||Odds Ratio (OR)|17.9|||<|0.0001|TWO_SIDED|95.0|4.38|73.09|||Cochran-Mantel-Haenszel|Stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|Cochran-Mantel-Haenszel stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||73.09|4.38|<0.0001
91737874|NCT04211363|183368319|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.0001|TWO_SIDED|95.0|2.33|138.2|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||138.20|2.33|<0.0001
91737875|NCT04211363|183368320|SUPERIORITY||Odds Ratio (OR)|29.36||||0.003|TWO_SIDED|95.0|2.99|288.36|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||288.36|2.99|0.003
91737876|NCT04211363|183368321|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1197|TWO_SIDED|95.0|0.98|3.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 2 Odds Ratio||3.19|0.98|0.1197
91737877|NCT04211363|183368321|SUPERIORITY||Odds Ratio (OR)|4.36|||<|0.0001|TWO_SIDED|95.0|2.31|8.26|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 4 Odds Ratio||8.26|2.31|<0.0001
91737878|NCT04211363|183368321|SUPERIORITY||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.85|15.94|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS at Week 8 Odds Ratio||15.94|3.85|<0.0001
91737879|NCT04211363|183368322|SUPERIORITY||Mean Difference (Final Values)|-25.83|||<|0.0001|TWO_SIDED|95.0|-31.7|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 4||-20.0|-31.7|<0.0001
91737880|NCT04211363|183368322|SUPERIORITY||Mean Difference (Final Values)|-30.9|||<|0.0001|TWO_SIDED|95.0|-37.2|-24.6|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 8||-24.6|-37.2|<0.0001
91737881|NCT01991860|183368323|SUPERIORITY|||||||0.033||||||2-sided|Chi-squared, Corrected|Yates's continuity correction||||||0.033
91737882|NCT01991860|183368324|SUPERIORITY|||||||0.16|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.16
91737883|NCT01991860|183368325|SUPERIORITY|||||||0.68|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.68
91737884|NCT01991860|183368326|SUPERIORITY|||||||0.026|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.026
91737885|NCT01991860|183368327|SUPERIORITY|||||||0.086|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.086
91737886|NCT01991860|183368328|SUPERIORITY|||||||0.074|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.074
91737887|NCT01991860|183368329|SUPERIORITY|||||||0.15|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.15
91737888|NCT02797821|183368333|OTHER||Least Squares (LS) Means Difference|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.544|-1.216||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the previous comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-1.216|-2.544|<0.0001
91737889|NCT02797821|183368333|OTHER||LS Means Difference|-1.193||||0.0008|TWO_SIDED|95.0|-1.805|-0.581||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the first comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-0.581|-1.805|0.0008
91737890|NCT02797821|183368334|OTHER||LS Means Difference|-34.047||||0.0128|TWO_SIDED|95.0|-60.171|-7.922||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-7.922|-60.171|0.0128
91737891|NCT02797821|183368334|OTHER||LS Means Difference|-29.492||||0.0239|TWO_SIDED|95.0|-54.723|-4.261||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-4.261|-54.723|0.0239
91737892|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-2.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
91737893|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
91737894|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
91737895|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-4.0|5.0||||||Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||5|-4|
91737896|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|5.0|||||TWO_SIDED|95.0|1.0|10.0||||||Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||10|1|
91760064|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.89|0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.89|
91498893|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
91737897|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|-6|
91737898|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-16.0|||||TWO_SIDED|95.0|-21.0|-10.0||||||Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||-10|-21|
91737899|NCT00518180|183368342|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
91737900|NCT00518180|183368343|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|2.0|||||TWO_SIDED|95.0|1.0|4.0||||||Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|1|
91737901|NCT00518180|183368343|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-1|
91737902|NCT00518180|183368352|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.9|0.72|
91737903|NCT00518180|183368352|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.81|0.58|
91737904|NCT00518180|183368352|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.67|||||TWO_SIDED|95.0|0.58|0.76||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.76|0.58|
91498894|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
91737905|NCT01957865|183368364|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Linear and Poisson regressions|||In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.||||<0.05
91737906|NCT01957865|183368365|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher's exact test|||HIV RNA suppression (\<100 copies/ml) was compared among study arms by Fisher's exact test.||||<0.05
91737907|NCT01419119|183368408|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91737908|NCT01419119|183368409|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91737909|NCT03768427|183368412|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-19.5|||<|0.001|TWO_SIDED|95.0|-26.7|-12.3|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (88 participants in arm Atorvastatin 10 mg - ezetimibe 10 mg/Ator 10 mg and 89 participants in arm Atorvastatin 10mg - Atorvastatin 20 mg)."|Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg.|-12.3|-26.7|<0.001
91704877|NCT03646305|183304387|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on state body image satisfaction||||>0.05
91704878|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, state body image satisfaction were equivalent across time.||||<0.001
91737910|NCT03768427|183368412|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED|95.0|-21.0|-10.7|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg and 140 participants in arm Atorvastatin 20 mg - Atorvastatin 40 mg)."|Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg.|-10.7|-21.0|<0.001
91737911|NCT03710889|183368431|OTHER|Within treatment paired t-tests were used to compare the differences in dynamic indices between Baseline and Month 3 using the Bone-Biopsy Population. If the normality assumption is not satisfied at the 0.01 significance level and visual inspection of the data deems it necessary, Wilcoxon signed-rank test is used. No adjustments for multiplicity were made. A 2-sided p-value \<0.05 was considered statistically significant.|||||<|0.0001|||||||Paired t-test, 2 sided|||||||<0.0001
91737912|NCT02121509|183368460|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.79|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|98.938|106.789|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||106.789|98.938|<0.0001
91737913|NCT02121509|183368460|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.026|<|0.0001|TWO_SIDED|90.0|96.99|106.121|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||106.121|96.990|<0.0001
91737914|NCT02121509|183368461|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.22|STANDARD_ERROR_OF_MEAN|1.046||0.0004|TWO_SIDED|90.0|98.449|114.614|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||114.614|98.449|0.0004
91737915|NCT02121509|183368461|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.71|STANDARD_ERROR_OF_MEAN|1.051||0.004|TWO_SIDED|90.0|97.614|116.658|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||116.658|97.614|0.0040
91737916|NCT02121509|183368462|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.03|STANDARD_ERROR_OF_MEAN|1.05||0.0001|TWO_SIDED|90.0|94.03|110.72|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.72|94.03|0.0001
91737917|NCT02121509|183368462|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|96.36|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|89.96|103.22|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.22|89.96|0.0002
91737918|NCT02121509|183368463|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.1|STANDARD_ERROR_OF_MEAN|1.057||0.0013|TWO_SIDED|90.0|95.829|115.269|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||115.269|95.829|0.0013
91737919|NCT02121509|183368463|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|113.91|STANDARD_ERROR_OF_MEAN|1.027||0.0018|TWO_SIDED|90.0|108.749|119.318|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||119.318|108.749|0.0018
91737920|NCT02121509|183368464|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|95.748|107.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||107.487|95.748|<0.0001
91737921|NCT02121509|183368464|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|106.33|STANDARD_ERROR_OF_MEAN|1.034||0.0002|TWO_SIDED|90.0|100.268|112.763|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||112.763|100.268|0.0002
91737922|NCT02121509|183368465|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.07|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|90.0|94.2|110.59|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.59|94.20|<0.0001
91737923|NCT02121509|183368465|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.79|STANDARD_ERROR_OF_MEAN|1.04||0.0001|TWO_SIDED|90.0|90.33|103.7|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.70|90.33|0.0001
91737924|NCT00636181|183368467|SUPERIORITY|||||||0.3||||||PSG outcomes employed analysis of variance for approximately normally distributed outcomes (or outcomes that could be transformed to an approximately normal distribution), and the Kruskal-Wallis test for non-normal outcomes.|Kruskal-Wallis|Pairwise differences were determined using Tukey-Kramer test- ANOVA applied or by Mann-Whitney-Wilcoxon summed rank tests and Bonferroni adjustment.||||||0.3
91737925|NCT00542178|183368475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.003|TWO_SIDED|95.0|0.51|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control||0.87|0.51|0.003
91737926|NCT00542178|183368475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.29|TWO_SIDED|95.0|0.84|1.79|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control||1.79|0.84|0.29
91737927|NCT00542178|183368475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.006|TWO_SIDED|95.0|0.42|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone||0.87|0.42|0.006
91737928|NCT00542178|183368476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.997||||0.96|TWO_SIDED|95.0|0.901|1.104|||Regression, Cox|||||1.104|0.901|0.96
91530984|NCT04707391|182938292|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup C.|Difference in percentage of participants|0.5|||||TWO_SIDED|0.95|-4.14|3.98||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.98|-4.14|
91704879|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in anxious mood from baseline to post-intervention. Null hypothesis: there would be no significant difference in anxious mood from baseline to post-intervention.||||<0.001
91704880|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in anxious mood from post-intervention to follow-up. Null hypothesis: there would be no significant difference in anxious mood from post-intervention to follow-up||||>0.05
91704881|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of anxiety||||>0.05
91704882|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of anxiety||||>0.05
91737929|NCT00542178|183368476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.5|TWO_SIDED|95.0|0.825|1.099|||Regression, Cox|||||1.099|0.825|0.50
91737930|NCT00542178|183368476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.762|1.016|||Regression, Cox|||||1.016|0.762|0.08
91737931|NCT00542178|183368477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.0355|TWO_SIDED|95.0|0.788|0.992|||Regression, Cox|||||0.992|0.788|0.0355
91737932|NCT00542178|183368477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891||||0.17|TWO_SIDED|95.0|0.755|1.051|||Regression, Cox|||||1.051|0.755|0.17
91737933|NCT00542178|183368477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.86|TWO_SIDED|95.0|0.865|1.19|||Regression, Cox|||||1.190|0.865|0.86
91737934|NCT00542178|183368478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.069|TWO_SIDED|95.0|0.71|1.69|||Regression, Logistic|||||1.69|0.71|0.069
91737935|NCT00542178|183368478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.63|TWO_SIDED|95.0|0.44|1.63|||Regression, Logistic|||||1.63|0.44|0.63
91737936|NCT00542178|183368478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.78|TWO_SIDED|95.0|0.6|1.96|||Regression, Logistic|||||1.96|0.60|0.78
91737937|NCT00829998|183368479|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|97.4||||||90.0|89.4|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|89.4|
91737938|NCT00829998|183368480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
91498895|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.5|<.0001
91737939|NCT00829998|183368481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
91759506|NCT02391363|183411757|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
91759507|NCT02391363|183411758|SUPERIORITY|||||||0.29||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.29
91498896|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
91759508|NCT02391363|183411759|SUPERIORITY|||||||0.14||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.14
91737940|NCT00896012|183368483|OTHER|||||||0.222||||||Significance was considered to be P \< .05|t-test, 2 sided|||Statistical analysis was performed by analysis of variance and Student t test for estimated glomerular filtration rate (eGFR) at 12 months. Chi-square analysis was used for demographics data.||||0.222
91737941|NCT02026011|183368489|SUPERIORITY_OR_OTHER|||||||0.39||||||Medication effect: b = -0.15, SE = 0.17, t = -0.86, p = 0.39|Mixed Models Analysis|||||||0.39
91737942|NCT02026011|183368489|SUPERIORITY_OR_OTHER|||||||0.34||||||Genotype effect: b = 0.20, SE = 0.21, t = 0.96, p = 0.34|Mixed Models Analysis|||||||0.34
91737943|NCT02026011|183368489|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.13, SE = 0.06, t = 2.10, p = 0.04|Mixed Models Analysis|||||||0.04
91737944|NCT02026011|183368489|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = 0.15, SE = 0.21, t = 0.73, p = 0.47|Mixed Models Analysis|||||||0.47
91737945|NCT02026011|183368489|SUPERIORITY_OR_OTHER|||||||0.13||||||Medication by genotype by BrAC interaction: b = -0.20, SE = 0.13, t = -1.52, p = 0.13|Mixed Models Analysis|||||||0.13
91737946|NCT02026011|183368490|SUPERIORITY_OR_OTHER|||||||0.23||||||Medication effect: b = 0.16, SE = 0.13, t = 1.20, p = 0.23|Mixed Models Analysis|||||||0.23
91737947|NCT02026011|183368490|SUPERIORITY_OR_OTHER|||||||0.09||||||Genotype effect: b = 0.37, SE = 0.22, t = 1.69, p = 0.09|Mixed Models Analysis|||||||0.09
91737948|NCT02026011|183368490|SUPERIORITY_OR_OTHER|||||||0.84||||||Medication by genotype interaction: b = 0.04, SE = 0.21, t = 0.20, p = 0.84|Mixed Models Analysis|||||||0.84
91737949|NCT02026011|183368490|SUPERIORITY_OR_OTHER|||||||0.05||||||Medication by genotype by BrAC interaction: b = -0.32, SE = 0.16, t = -1.93, p = 0.05|Mixed Models Analysis|||||||0.05
91737950|NCT02026011|183368491|SUPERIORITY_OR_OTHER|||||||0.55||||||Medication effect: b = 0.14, SE = 0.23, t = 0.61, p = 0.55|Mixed Models Analysis|||||||0.55
91737951|NCT02026011|183368491|SUPERIORITY_OR_OTHER|||||||0.77||||||Genotype effect: b = -0.11, SE = 0.37, t = -0.30, p = 0.77|Mixed Models Analysis|||||||0.77
91737952|NCT02026011|183368491|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.30, SE = 0.15, t = 2.02, p = 0.04|Mixed Models Analysis|||||||0.04
91737953|NCT02026011|183368491|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = -0.21, SE = 0.29, t = -0.72, p = 0.47|Mixed Models Analysis|||||||0.47
91737954|NCT02026011|183368491|SUPERIORITY_OR_OTHER|||||||0.19||||||Medication by genotype by BrAC interaction: b = 0.28, SE = 0.21, t = 1.30, p = 0.19|Mixed Models Analysis|||||||0.19
91737955|NCT02026011|183368493|SUPERIORITY_OR_OTHER|||||||0.14||||||Medication effect: F(1,71) = 2.24, p = 0.14|Poisson Regression|||||||0.14
91737956|NCT02026011|183368493|SUPERIORITY_OR_OTHER|||||||0.02||||||Genotype effect: F(1, 71) = 5.79, p = 0.02|Poisson|||||||0.02
91737957|NCT02026011|183368493|SUPERIORITY_OR_OTHER|||||||0.41||||||Medication by genotype interaction: F(1, 70) = 0.68, p = 0.41.|Poisson|||||||0.41
91737958|NCT00939107|183368505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||>|0.05||95.0|0.2|2.8|||t-test, 2 sided|||||2.8|0.2|>0.05
91498897|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67||||0.0005|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.0|0.0005
91737959|NCT00952705|183368534|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.|Ratio of geometric mean titers|0.95|||||TWO_SIDED|95.0|0.87|1.03|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.03|0.87|
91737960|NCT00952705|183368534|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.|Ratio of geometric mean titers|0.93|||||TWO_SIDED|95.0|0.85|1.0|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.00|0.85|
91737961|NCT00952705|183368534|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.|Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.79|1.02|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.02|0.79|
91760065|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-1.5|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.50|
91760066|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-1.0|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.00|
91760067|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.4|-0.43||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.43|-1.40|
91760068|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|||||TWO_SIDED|95.0|-1.77|-0.8||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.80|-1.77|
91760069|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.69|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-1.69|
91760070|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.98|-0.01||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.98|
91760071|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.69|-0.73||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-1.69|
91760072|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|0.04|0.78||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|0.04|
91737962|NCT00952705|183368534|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.|Ratio of geometric mean titers|0.97|||||TWO_SIDED|95.0|0.87|1.1|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.10|0.87|
91737963|NCT02921789|183368562|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||9.0|-34.5|0.3705
91737964|NCT02921789|183368563|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||9.0|-34.5|0.3705
91737965|NCT02921789|183368563|SUPERIORITY||Difference|-12.4||||0.389|TWO_SIDED|95.0|-35.8|11.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||11.0|-35.8|0.3890
91737966|NCT02921789|183368564|SUPERIORITY||Difference|6.9||||0.752|TWO_SIDED|95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||29.2|-15.3|0.7520
91737967|NCT02921789|183368564|SUPERIORITY||Difference|6.9||||0.752||95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||29.2|-15.3|0.7520
91737968|NCT02921789|183368564|SUPERIORITY||Difference|5.0||||0.7597|TWO_SIDED|95.0|-18.9|29.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||29.0|-18.9|0.7597
91737969|NCT02921789|183368565|SUPERIORITY||Difference|-0.3||||1||95.0|-24.9|24.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||24.3|-24.9|1.0
91737970|NCT02921789|183368566|SUPERIORITY||Difference|-3.9||||1||95.0|-30.2|22.4||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||22.4|-30.2|1.0
91737971|NCT02921789|183368566|SUPERIORITY||Difference|-6.2||||0.772||95.0|-31.7|19.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||19.3|-31.7|0.7720
91737972|NCT02921789|183368566|SUPERIORITY||Difference|-7.5||||0.772||95.0|-32.6|17.6||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||17.6|-32.6|0.7720
91737973|NCT01669902|183368591|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 3||||<0.0001
91737974|NCT01669902|183368591|SUPERIORITY_OR_OTHER|||||||0.0357|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 6||||0.0357
91737975|NCT01047189|183368595|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Kruskal-Wallis|||||||0.05
91737976|NCT02441218|183368639|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.75|0.9|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.90|0.75|<0.0001
91737977|NCT02441218|183368640|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.128|TWO_SIDED|95.0|0.8|1.03|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.03|0.80|0.128
91737978|NCT02441218|183368641|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.83|0.66|< 0.0001
91498898|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.28|||<|0.0001||95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
91737979|NCT02441218|183368642|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.8|1.02|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.02|0.80|0.092
91737980|NCT02441218|183368643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.014|TWO_SIDED|95.0|0.58|0.94|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.94|0.58|0.0140
91737981|NCT02441218|183368644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.0027|TWO_SIDED|95.0|0.82|0.96|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.96|0.82|0.0027
91737982|NCT02441218|183368645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.78|0.0002
91737983|NCT02441218|183368646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.95|0.81|0.0013
91737984|NCT02441218|183368647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0002|TWO_SIDED|95.0|0.77|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.77|0.0002
91737985|NCT02441218|183368648|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate. P-value: Wald test|||0.89|0.74|< 0.0001
91737986|NCT01436110|183368713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.43|TWO_SIDED|95.0|-0.055|0.128|||ANCOVA|||||0.128|-0.055|0.430
91737987|NCT01436110|183368713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.03|TWO_SIDED|95.0|0.01|0.194|||ANCOVA|||||0.194|0.010|0.030
91737988|NCT01088503|183368726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7108|TWO_SIDED|95.0|0.88|1.22||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank|||||1.22|0.88|0.7108
91737989|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.464|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with DES vs BMS.|||||
91737990|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI|||||
91737991|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.657|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.|||||
91737992|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.684|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.|||||
91737993|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were male vs not male.|||||
91737994|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. \<1.|||||
91737995|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were married vs not married.|||||
91737996|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.|||||
91737997|NCT01088503|183368727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.|||||
91737998|NCT01088503|183368728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.1882|TWO_SIDED|95.0|0.88|1.93||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||Hazard ratio (HR) is for the analysis at 12 months.|||1.93|0.88|0.1882
91737999|NCT01088503|183368729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.967|||||TWO_SIDED|95.0|0.849|1.103|||||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|||1.103|0.849|
91738000|NCT01088503|183368733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.|||||
91738001|NCT01088503|183368734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.005|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.|||||
91738002|NCT01847092|183368735|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||||||0.279
91738003|NCT01847092|183368736|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
91738004|NCT01896687|183368741|SUPERIORITY_OR_OTHER||||||<|0.001||||||"The worst pain and interference scores as dependent variables, and time (baseline, 1-, and 3 week follow up visit), group (Calmare or Sham), and group by time interaction terms as the independent variable."|ANOVA|||||||<0.001
91704883|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of anxiety||||>0.05
91704884|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of anxiety across time||||>0.05
91704885|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of anxiety||||>0.05
91704886|NCT03646305|183304388|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between the four conditions on levels of anxiety||||>0.05
91704887|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of depressive mood were equivalent across time.||||<0.001
91704888|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from depressive mood from baseline to post-intervention||||<0.001
91704889|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from post-intervention to follow-up. Null hypothesis: there would be no significant differences in depressive mood from post-intervention to follow-up.||||>0.05
91704890|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of depressive mood||||>0.05
91738005|NCT01664247|183368745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34|||<|0.0001|TWO_SIDED|95.0|-2.67|-2.01|||ANOVA||The treatment contrast estimated was IDeg - Placebo.|The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.||-2.01|-2.67|<.0001
91704891|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of depressive mood||||>0.05
91704892|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of depressive mood||||>0.05
91738006|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.34|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast.||-2.34|-3.04|<.0001
91704893|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of depressive mood across time||||>0.05
91498899|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
91498900|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
91738007|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.48|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after breakfast.||-1.48|-2.71|<.0001
91738008|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.56|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before lunch.||-1.56|-2.47|<.0001
91738009|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.4|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after start of lunch.||-1.40|-2.46|<.0001
91738010|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point main evening meal.||-1.23|-2.25|<.0001
91738011|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.26|-1.18|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after main evening meal.||-1.18|-2.26|<.0001
91738012|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.27|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before bedtime.||-1.23|-2.27|<.0001
91738013|NCT01664247|183368746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-2.91|-2.09|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast the following day.||-2.09|-2.91|<.0001
91738014|NCT01000506|183368751|SUPERIORITY_OR_OTHER||Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.69||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.69|0.39|<0.001
91498901|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
91498902|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
91498903|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
91738015|NCT01000506|183368751|SUPERIORITY_OR_OTHER||Rate Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.81||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.81|0.46|<0.001
91738016|NCT01000506|183368751|SUPERIORITY_OR_OTHER||Rate Ratio|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.64||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.36|<0.001
91738017|NCT05018689|183368787|SUPERIORITY||Mean Difference (Net)|0.04||||0.642|TWO_SIDED|95.0|-0.13|0.22|||Regression, Linear|||How confident to identify someone showing depression?||0.22|-0.13|0.642
91738018|NCT05018689|183368787|SUPERIORITY||Mean Difference (Net)|0.02||||0.864|TWO_SIDED|95.0|-0.21|0.25|||Regression, Linear|||How confident to help a friend?||0.25|-0.21|0.864
91738019|NCT05018689|183368788|SUPERIORITY||comparison of odds ratios|0.78||||0.336|TWO_SIDED|95.0|0.47|1.3|||Regression, Logistic|||||1.30|0.47|0.336
91738020|NCT05018689|183368789|SUPERIORITY||comparison of odds ratios|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Regression, Logistic|||Depression runs in families. Answer: true||1.59|0.70|0.806
91738021|NCT05018689|183368789|SUPERIORITY||comparison of odds ratios|0.96||||0.781|TWO_SIDED|95.0|0.71|1.3|||Regression, Logistic|||Depression can be controlled through willpower. Answer: false||1.30|0.71|0.781
91738022|NCT05018689|183368789|SUPERIORITY||comparison of odds ratios|0.93||||0.72|TWO_SIDED|95.0|0.62|1.39|||Regression, Logistic|||Depression is treatable. Answer: true||1.39|0.62|0.720
91738023|NCT05018689|183368789|SUPERIORITY||comparison of odds ratios|1.11||||0.784|TWO_SIDED|95.0|0.52|2.38|||Regression, Logistic|||Abuse of alcohol and drugs can be a sign of depression. Answer: true||2.38|0.52|0.784
91738024|NCT05018689|183368789|SUPERIORITY||comparison of odds ratios|1.08||||0.662|TWO_SIDED|95.0|0.76|1.55|||Regression, Logistic|||Depression is a sign of personal weakness. Answer: false||1.55|0.76|0.662
91738025|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|0.8||||0.34|TWO_SIDED|95.0|0.51|1.26|||Regression, Logistic|||Difficulty concentrating or making decisions||1.26|0.51|0.340
91738026|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|0.81||||0.265|TWO_SIDED|95.0|0.56|1.17|||Regression, Logistic|||Feeling angry||1.17|0.56|0.265
91738027|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|0.7||||0.259|TWO_SIDED|95.0|0.38|1.3|||Regression, Logistic|||Changes in sleep patterns||1.30|0.38|0.259
91738028|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|1.12||||0.45|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Frequent unexplained aches and pains||1.49|0.84|0.450
91738029|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|2.28||||0.025|TWO_SIDED|95.0|1.11|4.69|||Regression, Logistic|||Feeling tired or less energetic||4.69|1.11|0.025
91738030|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|1.01||||0.937|TWO_SIDED|95.0|0.71|1.44|||Regression, Logistic|||Eating more than usual||1.44|0.71|0.937
91738031|NCT05018689|183368790|SUPERIORITY||comparison of odds ratios|0.83||||0.447|TWO_SIDED|95.0|0.52|1.34|||Regression, Logistic|||Feeling irritable or restless||1.34|0.52|0.447
91738032|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.11|0.14|||Regression, Linear|||Friend||0.14|-0.11|0.800
91738033|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.05||||0.451|TWO_SIDED|95.0|-0.18|0.08|||Regression, Linear|||Parent/guardian||0.08|-0.18|0.451
91738034|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|0.07||||0.335|TWO_SIDED|95.0|-0.07|0.2|||Regression, Linear|||School counselor||0.2|-0.07|0.335
91738035|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.04||||0.554|TWO_SIDED|95.0|-0.17|0.09|||Regression, Linear|||Teacher||0.09|-0.17|0.554
91738036|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.04||||0.541|TWO_SIDED|95.0|-0.19|0.1|||Regression, Linear|||Mental health professional||0.10|-0.19|0.541
91738037|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|0.05||||0.454|TWO_SIDED|95.0|-0.09|0.19|||Regression, Linear|||Doctor||0.19|-0.09|0.454
91738038|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.02||||0.749|TWO_SIDED|95.0|-0.16|0.12|||Regression, Linear|||Internet/website||0.12|-0.16|0.749
91738039|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.13||||0.03|TWO_SIDED|95.0|-0.24|-0.01|||Regression, Linear|||Clergy, priest, rabbi, or other religious person||-0.01|-0.24|0.030
91738040|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|0.06||||0.334|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||Phone helpline||0.18|-0.06|0.334
91738041|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|0.07||||0.243|TWO_SIDED|95.0|-0.05|0.2|||Regression, Linear|||Crisis textline||0.20|-0.05|0.243
91738042|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.05||||0.492|TWO_SIDED|95.0|-0.19|0.09|||Regression, Linear|||Other relative (i.e., sister, brother, aunt, uncle)||0.09|-0.19|0.492
91738043|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Regression, Linear|||Boyfriend or girlfriend||0.10|-0.17|0.610
91738044|NCT05018689|183368791|SUPERIORITY||Mean Difference (Net)|-0.12||||0.061|TWO_SIDED|95.0|-0.25|0.01|||Regression, Linear|||Coach||0.01|-0.25|0.061
91738045|NCT05018689|183368792|SUPERIORITY||comparison of odds ratios|1.27||||0.086|TWO_SIDED|95.0|0.97|1.66|||Regression, Logistic|||If you had depression symptoms for more than 2 weeks, would you ask for help?||1.66|0.97|0.086
91738046|NCT05018689|183368792|SUPERIORITY||comparison of odds ratios|1.13||||0.526|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic|||If you thought you had mental health issues, is there a trusted adult you would go to?||1.66|0.77|0.526
91704894|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of depressive mood||||>0.05
91704895|NCT03646305|183304389|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on levels of depressive mood||||>0.05
91704896|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of happiness were equivalent across time||||>0.05
91704897|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of happiness||||>0.05
91704898|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of happiness||||>0.05
91704899|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of happiness||||>0.05
91704900|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of happiness across time.||||>0.05
91738047|NCT05018689|183368793|SUPERIORITY||Mean Difference (Net)|0.06||||0.199|TWO_SIDED|95.0|-0.03|0.16|||Regression, Linear|||Do you know how to get help in your school?||0.16|-0.03|0.199
91738048|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||Regression, Linear|||The new student is more dangerous than other students||-0.12|-0.38|<0.001
91738049|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|-0.18||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Regression, Linear|||The student is to blame for his or her condition||-0.06|-0.29|0.003
91738050|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||I would have sympathy for the new student||0.18|-0.06|0.310
91738051|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|-0.1||||0.114|TWO_SIDED|95.0|-0.21|0.02|||Regression, Linear|||The new student makes me feel scared||0.02|-0.21|0.114
91738052|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|0.02||||0.738|TWO_SIDED|95.0|-0.1|0.15|||Regression, Linear|||The new student makes me feel uncomfortable||0.15|-0.10|0.738
91738053|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|0.12||||0.04|TWO_SIDED|95.0|0.01|0.24|||Regression, Linear|||I would help the new student even if I did not know him or her well||0.24|0.01|0.040
91738054|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|-0.17||||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Regression, Linear|||I would try to stay away from the new student||-0.05|-0.29|0.006
91738055|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|-0.02||||0.798|TWO_SIDED|95.0|-0.15|0.11|||Regression, Linear|||The new student would be made fun of at my school||0.11|-0.15|0.798
91738056|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|-0.09||||0.197|TWO_SIDED|95.0|-0.22|0.05|||Regression, Linear|||The new student would be ignored at my school||0.05|-0.22|0.197
91738057|NCT05018689|183368794|SUPERIORITY||Mean Difference (Net)|0.03||||0.623|TWO_SIDED|95.0|-0.1|0.16|||Regression, Linear|||I think other students in my school would try to help the new student||0.16|-0.10|0.623
91738058|NCT05018689|183368795|SUPERIORITY||Mean Difference (Net)|0.05||||0.718|TWO_SIDED|95.0|-0.21|0.3|||Regression, Linear|||On a scale from 1 to 7, if you were seen going into the office of your school social worker or school psychologist, how would you feel?||0.30|-0.21|0.718
91738059|NCT05018689|183368796|SUPERIORITY||Mean Difference (Net)|0.21||||0.09|TWO_SIDED|95.0|-0.03|0.46|||Regression, Linear|||How comfortable are you talking about mental health issues with other students at your school?||0.46|-0.03|0.090
91738060|NCT05018689|183368797|SUPERIORITY||comparison of odds ratios|0.99||||0.944|TWO_SIDED|95.0|0.67|1.44|||Regression, Logistic|||Depression||1.44|0.67|0.944
91738061|NCT05018689|183368797|SUPERIORITY||comparison of odds ratios|1.18||||0.369|TWO_SIDED|95.0|0.82|1.68|||Regression, Logistic|||Anxiety||1.68|0.82|0.369
91738062|NCT05018689|183368797|SUPERIORITY||comparison of odds ratios|1.07||||0.676|TWO_SIDED|95.0|0.77|1.5|||Regression, Logistic|||Thoughts of suicide||1.50|0.77|0.676
91738063|NCT05018689|183368797|SUPERIORITY||comparison of odds ratios|0.79||||0.432|TWO_SIDED|95.0|0.44|1.42|||Regression, Logistic|||I do not think there are any mental health issues that are concerning for students||1.42|0.44|0.432
91738064|NCT05018689|183368797|SUPERIORITY||comparison of odds ratios|0.87||||0.533|TWO_SIDED|95.0|0.56|1.35|||Regression, Logistic|||Other||1.35|0.56|0.533
91738065|NCT05018689|183368798|SUPERIORITY||Mean Difference (Net)|-0.01||||0.769|TWO_SIDED|95.0|-0.11|0.08|||Regression, Linear|||How much do your teachers know about addressing student mental health needs?||0.08|-0.11|0.769
91738066|NCT05018689|183368798|SUPERIORITY||Mean Difference (Net)|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||Regression, Linear|||How much do your school counselors know about addressing student mental health needs?||0.16|-0.05|0.315
91738067|NCT05018689|183368799|SUPERIORITY||comparison of odds ratios|0.86||||0.345|TWO_SIDED|95.0|0.63|1.18|||Regression, Logistic|||Mental health information sheets at school||1.18|0.63|0.345
91738068|NCT05018689|183368799|SUPERIORITY||comparison of odds ratios|0.98||||0.899|TWO_SIDED|95.0|0.73|1.33|||Regression, Logistic|||Class activities about mental health||1.33|0.73|0.899
91738069|NCT05018689|183368799|SUPERIORITY||comparison of odds ratios|1.08||||0.612|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Mental health information on school website||1.48|0.80|0.612
91738070|NCT05018689|183368799|SUPERIORITY||comparison of odds ratios|1.14||||0.476|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||Other||1.65|0.79|0.476
91738071|NCT05018689|183368800|SUPERIORITY||Mean Difference (Net)|-0.09||||0.141|TWO_SIDED|95.0|-0.22|0.03|||Regression, Linear|||On average, how often do your teachers speak to you about your emotions and feelings?||0.03|-0.22|0.141
91738072|NCT05018689|183368801|SUPERIORITY||Mean Difference (Net)|0.04||||0.392|TWO_SIDED|95.0|-0.05|0.13|||Regression, Linear|||Would you like your teachers to speak to you about your emotions and feelings?||0.13|-0.05|0.392
91738073|NCT01448616|183368813|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.86||||0.086|TWO_SIDED|95.0|0.71|1.01||ITT|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.01|0.71|0.086
91738074|NCT01448616|183368813|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.94||||0.54|TWO_SIDED|95.0|0.75|1.16||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.16|0.75|0.54
91738075|NCT01448616|183368813|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.22|0.67|0.47
91738076|NCT01448616|183368814|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.16||||0.18|TWO_SIDED|95.0|-0.4|0.07|||Linear Mixed Effects Model|||Intent to treat analysis||0.07|-0.40|0.18
91738077|NCT01448616|183368814|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.5||||0.008|TWO_SIDED|95.0|-0.86|-0.13|||Linear Mixed Effects Model|||Intent to treat analysis||-0.13|-0.86|0.008
91738078|NCT01448616|183368814|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|0.16||||0.45|TWO_SIDED|95.0|-0.27|0.6|||Linear Mixed Effects Model|||Intent to treat analysis||0.60|-0.27|0.45
91738079|NCT01448616|183368815|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.9|TWO_SIDED|95.0|0.7|1.37|||Poisson GLME|||Intent to treat analysis||1.37|0.70|0.90
91498904|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
91738080|NCT01448616|183368815|SUPERIORITY||Risk Ratio (RR)|0.8||||0.25|TWO_SIDED|95.0|0.54|1.18|||Poisson GLM|||Intent to treat||1.18|0.54|0.25
91738081|NCT01448616|183368815|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.57|1.57|||Poisson GLM|||||1.57|0.57|0.82
91738082|NCT01448616|183368816|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.01|TWO_SIDED|95.0|0.59|0.92|||Poisson GLME|||Intent to Treat||0.92|0.59|0.010
91738083|NCT01448616|183368816|SUPERIORITY||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|0.9|1.76|||Poisson GLM|||||1.76|0.9|0.09
91738084|NCT01448616|183368816|SUPERIORITY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLM|||Intent to treat analysis||1.22|0.67|0.47
91738085|NCT00523978|183368821|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is the success rate in experimental group is less than and equal to the one in control group. This comparison of the rates was performed using a 2-sided Fisher's Exact. A sample size of 240(160 experimental and 80 control) is required to provide 80% power to detect the treatment difference using a 2-sided (alpha = 0.05)Fisher's Exact Test of binomial proportions assuming the success rate was 40% for control and 60% for treatment.||||<0.0001
91738086|NCT00523978|183368822|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin was selected based on literature review.|||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is the proportion of subjects free from MAFE in the experimental group is inferior to that in the control group using 10% non-inferiority margin.A sample size of 160 evaluable cryoablation and 80 control subjects (one-sided α = 0.05, 2:1 randomization) was required to provide 80% power assuming the rate of free from MAFE at 12 months 80.5 and 77% in experimental and control groups respectively .||||<0.001
91738087|NCT00523978|183368823|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||The test hypothesis is UCBExperimental\_CPE ≥ 14.8% vs UCBExperimental\_CPE \< 14.8%.The performance goal 14.8% was chosen based on a review of SSEDs for similar types of ablation trials.The expected rate for CPEs in a well-monitored trial of left atrial RF ablation for AF was estimated to be 10% (corresponding to a CPE-free rate of 90%).In a trial with 160 subject, the resulting one-sided 95% upper confidence bound would be 14.8%.||||<0.001
91738088|NCT01074125|183368841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3376|||<|0.0001|TWO_SIDED||||||Regression, Linear|||To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05||||<0.0001
91498905|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
91498906|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
91738089|NCT00587041|183368862|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||80% power for 0.66 DG difference from placebo. The reported value is the overall p-value for CaOx supersaturation by Kruskal-Wallis test of equal change across all three groups, no pair-wise comparison.||||0.3
91738090|NCT00587041|183368862|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 1 sided|||Ranked sum T-test for placebo group CaOx SS comparison between 0 and 6 weeks||||0.045
91738091|NCT00587041|183368862|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 1 sided|||Ranked sum T-test for AKSB group CaOX SS comparison between 0 and 6 weeks||||0.67
91738092|NCT00587041|183368862|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 1 sided|||Ranked-sum T-Test for Oxadrop group CaOX SS comparison between 0 and 6 weeks||||0.30
91738093|NCT02271529|183368877|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power \> 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.|Mean percent change|-1.0|||<|0.01|TWO_SIDED|95.0|-1.5|-0.4|||two one-sided t-tests|||||-0.4|-1.5|<0.01
91738094|NCT00811720|183368891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|0.75||0.002|TWO_SIDED|95.0|-3.81|-0.85|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.85|-3.81|0.002
91738095|NCT00811720|183368892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-16.81|-5.11|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-5.11|-16.81|<0.001
91738096|NCT00811720|183368893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.039|TWO_SIDED|95.0|0.5|0.98|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.||0.98|0.50|0.039
91738097|NCT00811720|183368894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.16|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.16|-0.57|<0.001
91738098|NCT00811720|183368895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.15|-0.53|<0.001
91738099|NCT00811720|183368896|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.009|TWO_SIDED|95.0|0.8|0.97|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.97|0.80|0.009
91738100|NCT00811720|183368897|SUPERIORITY_OR_OTHER||Ratio to placebo|0.9||||0.011|TWO_SIDED|95.0|0.84|0.98|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||0.98|0.84|0.011
91738101|NCT04389866|183368905|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_DEVIATION|0.864||0.018|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.018
91738102|NCT04389866|183368905|SUPERIORITY||Mean Difference (Final Values)|-0.214|STANDARD_DEVIATION|0.864||0.082|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 2 (jawline and lateral zygomatic cheek area injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.082
91738103|NCT04389866|183368906|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|0.497||3.1e-07|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.00000031
91738104|NCT04389866|183368906|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.497||7.28e-05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections arm analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0000728
91738105|NCT04389866|183368907|SUPERIORITY||Mean Difference (Final Values)|-0.571|STANDARD_DEVIATION|0.611||0.014|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline injections analysis of Jawline Rating Scale Assessments given by subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.014
91738106|NCT04389866|183368907|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.726||0.0065|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections analysis of Jawline Rating Scale Assessments given by the subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0065
91738107|NCT01205503|183368926|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).|Mixed Models Analysis|Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.||||||0.014
91738108|NCT00776789|183368932|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4
91738109|NCT00776789|183368933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0||95.0|1.4|4.3|||Wilcoxon (Mann-Whitney)|||Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control group||4.3|1.4|0.00
91738110|NCT00776789|183368934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001||95.0|1.6|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|1.6|0.001
91738111|NCT02742129|183368936|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.2||||0.265|TWO_SIDED|95.0|-0.56|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.56|0.2650
91738112|NCT02742129|183368937|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis|Mean Difference (Final Values)|-14.68||||0.9069|TWO_SIDED|95.0|-263.65|234.29|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data||234.29|-263.65|0.9069
91738113|NCT02742129|183368938|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.05||||0.9338|TWO_SIDED|95.0|-1.16|1.27|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||1.27|-1.16|0.9338
91738114|NCT02742129|183368939|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.29||||0.8151|TWO_SIDED|95.0|-2.79|2.2|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||2.20|-2.79|0.8151
91738115|NCT02742129|183368940|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.82||||0.4658|TWO_SIDED|95.0|-1.41|3.05|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.05|-1.41|0.4658
91738116|NCT02742129|183368941|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|1.06||||0.3902|TWO_SIDED|95.0|-1.37|3.49|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.49|-1.37|0.3902
91498907|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
91498908|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
91498909|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0037|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0037
91704901|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
91705778|NCT06010732|183305910|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.6|21.7|<0.001
91738117|NCT02742129|183368942|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|10.69||||0.7404|TWO_SIDED|95.0|-53.21|74.6|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||74.6|-53.21|0.7404
91738118|NCT02742129|183368943|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Median Difference (Final Values)|0.05||||0.4282|TWO_SIDED|95.0|-0.08|0.18|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.18|-0.08|0.4282
91738119|NCT02742129|183368945|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.49||||0.1067|TWO_SIDED|95.0|-1.08|0.11|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.11|-1.08|0.1067
91738120|NCT02742129|183368946|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.1||||0.4411|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.37|0.4411
91738121|NCT00363311|183368947|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.56||||0.009||95.0|0.36|0.87||Statistical data are for Year 1.5|Log Rank|||||0.87|0.36|0.009
91738122|NCT00363311|183368947|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.61||||0.007||95.0|0.43|0.88||Statistical data are for Overall (Years 0-3)|Log Rank|||||0.88|0.43|0.007
91738123|NCT00363311|183368948|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.46||||0.13||95.0|0.16|1.31||Statistical data are for Year 1.5|Log Rank|||||1.31|0.16|0.13
91738124|NCT00363311|183368948|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.48||||0.053||95.0|0.22|1.03||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.03|0.22|0.053
91738125|NCT00363311|183368949|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59||||0.031||95.0|0.36|0.96||Statistical data are for Year 1.5|Log Rank|||||0.96|0.36|0.031
91535605|NCT00991276|182949770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.48|STANDARD_ERROR_OF_MEAN|3.2||0.0036|TWO_SIDED|95.0|-15.81|-3.16||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.16|-15.81|0.0036
91738126|NCT00363311|183368949|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.7||||0.079||95.0|0.46|1.05||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.05|0.46|0.079
91738127|NCT00363311|183368950|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Fisher Exact|||||||0.65
91738128|NCT00363311|183368951|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
91738129|NCT00363311|183368958|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
91738130|NCT00363311|183368959|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.039
91738131|NCT00363311|183368961|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.80
91738132|NCT00363311|183368962|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
91738133|NCT04881760|183368985|SUPERIORITY||LS Mean difference (Final Values)|-5.64|||<|0.001|TWO_SIDED|95.0|-7.34|-3.94|||Mixed Models Analysis|||||-3.94|-7.34|<0.001
91738134|NCT04881760|183368985|SUPERIORITY||LS Mean difference (Final Values)|-10.45|||<|0.001|TWO_SIDED|95.0|-12.21|-8.7|||Mixed Models Analysis|||||-8.70|-12.21|<0.001
91738135|NCT04881760|183368985|SUPERIORITY||LS Mean difference (Final Values)|-12.25|||<|0.001|TWO_SIDED|95.0|-14.42|-10.08|||Mixed Models Analysis|||||-10.08|-14.42|<0.001
91738136|NCT04881760|183368985|SUPERIORITY||LS Mean difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-16.9|-13.3|||Mixed Models Analysis|||||-13.30|-16.90|<0.001
91738137|NCT04881760|183368985|SUPERIORITY||LS Mean difference (Final Values)|-16.72|||<|0.001|TWO_SIDED|95.0|-18.86|-14.58|||Mixed Models Analysis|||||-14.58|-18.86|<0.001
91738138|NCT04881760|183368985|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-17.57|-14.13|||Mixed Models Analysis|||||-14.13|-17.57|<0.001
91738139|NCT04881760|183368986|SUPERIORITY||LS Mean difference (Final Values)|-6.57|||<|0.001|TWO_SIDED|95.0|-8.94|-4.2|||Mixed Models Analysis|||||-4.20|-8.94|<0.001
91738140|NCT04881760|183368986|SUPERIORITY||LS Mean difference (Final Values)|-14.21|||<|0.001|TWO_SIDED|95.0|-17.64|-10.78|||Mixed Models Analysis|||||-10.78|-17.64|<0.001
91738141|NCT04881760|183368986|SUPERIORITY||LS Mean difference (Final Values)|-15.72|||<|0.001|TWO_SIDED|95.0|-19.05|-12.4|||Mixed Models Analysis|||||-12.40|-19.05|<0.001
91738142|NCT04881760|183368986|SUPERIORITY||LS Mean difference (Final Values)|-19.62|||<|0.001|TWO_SIDED|95.0|-22.73|-16.51|||Mixed Models Analysis|||||-16.51|-22.73|<0.001
91738143|NCT04881760|183368986|SUPERIORITY||LS Mean difference (Final Values)|-21.78|||<|0.001|TWO_SIDED|95.0|-25.05|-18.51|||Mixed Models Analysis|||||-18.51|-25.05|<0.001
91738144|NCT04881760|183368986|SUPERIORITY||LS Mean difference (Final Values)|-22.11|||<|0.001|TWO_SIDED|95.0|-24.92|-19.31|||Mixed Models Analysis|||||-19.31|-24.92|<0.001
91738145|NCT04881760|183368987|SUPERIORITY||Risk Difference (RD)|33.0|||<|0.001|TWO_SIDED|95.0|17.0|49.0|||Regression, Logistic|||||49|17|<0.001
91738146|NCT04881760|183368987|SUPERIORITY||Risk Difference (RD)|61.0|||<|0.001|TWO_SIDED|95.0|45.0|77.0|||Regression, Logistic|||||77|45|<0.001
91738147|NCT04881760|183368987|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|54.0|81.0|||Regression, Logistic|||||81|54|<0.001
91738148|NCT04881760|183368987|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
91738149|NCT04881760|183368987|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
91738150|NCT04881760|183368987|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|59.0|82.0|||Regression, Logistic|||||82|59|<0.001
91738151|NCT04881760|183368988|SUPERIORITY||Risk Difference (RD)|37.0|||<|0.001|TWO_SIDED|95.0|20.0|54.0|||Regression, Logistic|||||54|20|<0.001
91738152|NCT04881760|183368988|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.001|TWO_SIDED|95.0|44.0|76.0|||Regression, Logistic|||||76|44|<0.001
91738153|NCT04881760|183368988|SUPERIORITY||Risk Difference (RD)|70.0|||<|0.001|TWO_SIDED|95.0|57.0|83.0|||Regression, Logistic|||||83|57|<0.001
91738154|NCT04881760|183368988|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
91738155|NCT04881760|183368988|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
91738156|NCT04881760|183368988|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|67.0|84.0|||Regression, Logistic|||||84|67|<0.001
91738157|NCT04881760|183368989|SUPERIORITY||Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|11.0|33.0|||Regression, Logistic|||||33|11|<0.001
91738158|NCT04881760|183368989|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|38.0|73.0|||Regression, Logistic|||||73|38|<0.001
91738159|NCT04881760|183368989|SUPERIORITY||Risk Difference (RD)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|85.0|||Regression, Logistic|||||85|53|<0.001
91738160|NCT04881760|183368989|SUPERIORITY||Risk Difference (RD)|80.0|||<|0.001|TWO_SIDED|95.0|66.0|93.0|||Regression, Logistic|||||93|66|<0.001
91738161|NCT04881760|183368989|SUPERIORITY||Risk Difference (RD)|91.0|||<|0.001|TWO_SIDED|95.0|83.0|100.0|||Regression, Logistic|||||100|83|<0.001
91738162|NCT04881760|183368989|SUPERIORITY||Risk Difference (RD)|87.0|||<|0.001|TWO_SIDED|95.0|78.0|96.0|||Regression, Logistic|||||96|78|<0.001
91738163|NCT04881760|183368990|SUPERIORITY||Risk Difference (RD)|18.0||||0.008|TWO_SIDED|95.0|5.0|31.0|||Regression, Logistic|||||31|5|0.008
91738164|NCT04881760|183368990|SUPERIORITY||Risk Difference (RD)|64.0|||<|0.001|TWO_SIDED|95.0|48.0|81.0|||Regression, Logistic|||||81|48|<0.001
91738165|NCT04881760|183368990|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|84.0|||Regression, Logistic|||||84|51|<0.001
91738166|NCT04881760|183368990|SUPERIORITY||Risk Difference (RD)|81.0|||<|0.001|TWO_SIDED|95.0|69.0|94.0|||Regression, Logistic|||||94|69|<0.001
91738167|NCT04881760|183368990|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|94.0|||Regression, Logistic|||||94|71|<0.001
91738168|NCT04881760|183368990|SUPERIORITY||Risk Difference (RD)|84.0|||<|0.001|TWO_SIDED|95.0|74.0|94.0|||Regression, Logistic|||||94|74|<0.001
91738169|NCT04881760|183368991|SUPERIORITY||Risk Difference (RD)|9.0||||0.029|TWO_SIDED|95.0|1.0|17.0|||Regression, Logistic|||||17|1|0.029
91738170|NCT04881760|183368991|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|11.0|43.0|||Regression, Logistic|||||43|11|<0.001
91738171|NCT04881760|183368991|SUPERIORITY||Risk Difference (RD)|43.0|||<|0.001|TWO_SIDED|95.0|26.0|60.0|||Regression, Logistic|||||60|26|<0.001
91738172|NCT04881760|183368991|SUPERIORITY||Risk Difference (RD)|49.0|||<|0.001|TWO_SIDED|95.0|33.0|66.0|||Regression, Logistic|||||66|33|<0.001
91738173|NCT04881760|183368991|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|83.0|||Regression, Logistic|||||83|51|<0.001
91738174|NCT04881760|183368991|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|56.0|80.0|||Regression, Logistic|||||80|56|<0.001
91738175|NCT04881760|183368992|SUPERIORITY||Risk Difference (RD)|15.0||||0.002|TWO_SIDED|95.0|6.0|24.0|||Regression, Logistic|||||24|6|0.002
91738176|NCT04881760|183368992|SUPERIORITY||Risk Difference (RD)|53.0|||<|0.001|TWO_SIDED|95.0|36.0|70.0|||Regression, Logistic|||||70|36|<0.001
91738177|NCT04881760|183368992|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|47.0|79.0|||Regression, Logistic|||||79|47|<0.001
91738178|NCT04881760|183368992|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|55.0|87.0|||Regression, Logistic|||||87|55|<0.001
91738179|NCT04881760|183368992|SUPERIORITY||Risk Difference (RD)|75.0|||<|0.001|TWO_SIDED|95.0|62.0|89.0|||Regression, Logistic|||||89|62|<0.001
91738180|NCT04881760|183368992|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|92.0|||Regression, Logistic|||||92|71|<0.001
91738181|NCT04881760|183368993|SUPERIORITY||LS Mean difference (Final Values)|-6.46|||<|0.001|TWO_SIDED|95.0|-8.36|-4.56|||Mixed Models Analysis|||||-4.56|-8.36|<0.001
91738182|NCT04881760|183368993|SUPERIORITY||LS Mean difference (Final Values)|-11.32|||<|0.001|TWO_SIDED|95.0|-13.34|-9.3|||Mixed Models Analysis|||||-9.30|-13.34|<0.001
91738183|NCT04881760|183368993|SUPERIORITY||LS Mean difference (Final Values)|-13.52|||<|0.001|TWO_SIDED|95.0|-15.99|-11.05|||Mixed Models Analysis|||||-11.05|-15.99|<0.001
91738184|NCT04881760|183368993|SUPERIORITY||LS Mean difference (Final Values)|-16.43|||<|0.001|TWO_SIDED|95.0|-18.41|-14.45|||Mixed Models Analysis|||||-14.45|-18.41|<0.001
91738185|NCT04881760|183368993|SUPERIORITY||LS Mean difference (Final Values)|-18.48|||<|0.001|TWO_SIDED|95.0|-20.93|-16.04|||Mixed Models Analysis|||||-16.04|-20.93|<0.001
91738186|NCT04881760|183368993|SUPERIORITY||LS Mean difference (Final Values)|-17.26|||<|0.001|TWO_SIDED|95.0|-19.11|-15.4|||Mixed Models Analysis|||||-15.40|-19.11|<0.001
91738187|NCT04881760|183368994|SUPERIORITY||LS Mean difference (Final Values)|-7.53|||<|0.001|TWO_SIDED|95.0|-10.18|-4.88|||Mixed Models Analysis|||||-4.88|-10.18|<0.001
91738188|NCT04881760|183368994|SUPERIORITY||LS Mean difference (Final Values)|-15.48|||<|0.001|TWO_SIDED|95.0|-19.35|-11.6|||Mixed Models Analysis|||||-11.60|-19.35|<0.001
91738189|NCT04881760|183368994|SUPERIORITY||LS Mean difference (Final Values)|-17.29|||<|0.001|TWO_SIDED|95.0|-21.19|-13.39|||Mixed Models Analysis|||||-13.39|-21.19|<0.001
91738190|NCT04881760|183368994|SUPERIORITY||LS Mean difference (Final Values)|-21.69|||<|0.001|TWO_SIDED|95.0|-25.25|-18.12|||Mixed Models Analysis|||||-18.12|-25.25|<0.001
91738191|NCT04881760|183368994|SUPERIORITY||LS Mean difference (Final Values)|-24.04|||<|0.001|TWO_SIDED|95.0|-27.72|-20.36|||Mixed Models Analysis|||||-20.36|-27.72|<0.001
91738192|NCT04881760|183368994|SUPERIORITY||LS Mean difference (Final Values)|-24.34|||<|0.001|TWO_SIDED|95.0|-27.4|-21.27|||Mixed Models Analysis|||||-21.27|-27.40|<0.001
91738193|NCT04881760|183368995|SUPERIORITY||LS Mean difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||Mixed Models Analysis|||||-1.50|-2.80|<0.001
91738194|NCT04881760|183368995|SUPERIORITY||LS Mean difference (Final Values)|-3.98|||<|0.001|TWO_SIDED|95.0|-4.66|-3.29|||Mixed Models Analysis|||||-3.29|-4.66|<0.001
91738195|NCT04881760|183368995|SUPERIORITY||LS Mean difference (Final Values)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.46|-3.82|||Mixed Models Analysis|||||-3.82|-5.46|<0.001
91738196|NCT04881760|183368995|SUPERIORITY||LS Mean difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-6.34|-4.99|||Mixed Models Analysis|||||-4.99|-6.34|<0.001
91738197|NCT04881760|183368995|SUPERIORITY||LS Mean difference (Final Values)|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.53|||Mixed Models Analysis|||||-5.53|-7.17|<0.001
91738198|NCT04881760|183368995|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-6.59|-5.32|||Mixed Models Analysis|||||-5.32|-6.59|<0.001
91738199|NCT04881760|183368996|SUPERIORITY||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.42|-1.57|||Mixed Models Analysis|||||-1.57|-3.42|<0.001
91738200|NCT04881760|183368996|SUPERIORITY||LS Mean difference (Final Values)|-5.42|||<|0.001|TWO_SIDED|95.0|-6.81|-4.03|||Mixed Models Analysis|||||-4.03|-6.81|<0.001
91738201|NCT04881760|183368996|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-7.23|-4.67|||Mixed Models Analysis|||||-4.67|-7.23|<0.001
91738202|NCT04881760|183368996|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-8.62|-6.18|||Mixed Models Analysis|||||-6.18|-8.62|<0.001
91738203|NCT04881760|183368996|SUPERIORITY||LS Mean difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-9.55|-7.05|||Mixed Models Analysis|||||-7.05|-9.55|<0.001
91738204|NCT04881760|183368996|SUPERIORITY||LS Mean difference (Final Values)|-8.42|||<|0.001|TWO_SIDED|95.0|-9.49|-7.35|||Mixed Models Analysis|||||-7.35|-9.49|<0.001
91738205|NCT04881760|183368997|SUPERIORITY||LS Mean difference (Final Values)|-2.82||||0.022|TWO_SIDED|95.0|-5.23|-0.41|||Mixed Models Analysis|||||-0.41|-5.23|0.022
91738206|NCT04881760|183368997|SUPERIORITY||LS Mean difference (Final Values)|-7.73|||<|0.001|TWO_SIDED|95.0|-10.32|-5.13|||Mixed Models Analysis|||||-5.13|-10.32|<0.001
91738207|NCT04881760|183368997|SUPERIORITY||LS Mean difference (Final Values)|-9.95|||<|0.001|TWO_SIDED|95.0|-12.47|-7.43|||Mixed Models Analysis|||||-7.43|-12.47|<0.001
91738208|NCT04881760|183368997|SUPERIORITY||LS Mean difference (Final Values)|-11.14|||<|0.001|TWO_SIDED|95.0|-13.72|-8.56|||Mixed Models Analysis|||||-8.56|-13.72|<0.001
91738209|NCT04881760|183368997|SUPERIORITY||LS Mean difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-14.87|-9.9|||Mixed Models Analysis|||||-9.90|-14.87|<0.001
91738210|NCT04881760|183368997|SUPERIORITY||LS Mean difference (Final Values)|-11.73|||<|0.001|TWO_SIDED|95.0|-14.04|-9.43|||Mixed Models Analysis|||||-9.43|-14.04|<0.001
91738211|NCT04881760|183368998|SUPERIORITY||LS Mean difference (Final Values)|-3.84||||0.01|TWO_SIDED|95.0|-6.77|-0.91|||Mixed Models Analysis|||||-0.91|-6.77|0.010
91738212|NCT04881760|183368998|SUPERIORITY||LS Mean difference (Final Values)|-11.94|||<|0.001|TWO_SIDED|95.0|-15.54|-8.33|||Mixed Models Analysis|||||-8.33|-15.54|<0.001
91738213|NCT04881760|183368998|SUPERIORITY||LS Mean difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.11|-8.33|||Mixed Models Analysis|||||-8.33|-16.11|<0.001
91738214|NCT04881760|183368998|SUPERIORITY||LS Mean difference (Final Values)|-15.88|||<|0.001|TWO_SIDED|95.0|-19.33|-12.43|||Mixed Models Analysis|||||-12.43|-19.33|<0.001
91738215|NCT04881760|183368998|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-19.39|-12.31|||Mixed Models Analysis|||||-12.31|-19.39|<0.001
91738216|NCT04881760|183368998|SUPERIORITY||LS Mean difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-20.13|-13.78|||Mixed Models Analysis|||||-13.78|-20.13|<0.001
91738217|NCT01595529|183369006|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.035569|||||ONE_SIDED|95.0||0.054844||||||||0.054844||
91738218|NCT01595529|183369007|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.022169|||||ONE_SIDED|95.0||0.03939||||||||0.03939||
91738219|NCT01595529|183369008|SUPERIORITY||Risk Difference (RD)|-0.00356|||||TWO_SIDED|95.0|-0.03323|0.026102||||||||0.026102|-0.03323|
91738220|NCT01595529|183369009|SUPERIORITY||Risk Difference (RD)|-0.00994|||||TWO_SIDED|95.0|-0.04012|0.020236||||||||0.020236|-0.04012|
91738221|NCT01595529|183369010|SUPERIORITY|||||||0.2282|||||||Chi-squared|||At Test of Cure Visit||||0.2282
91738222|NCT01595529|183369010|SUPERIORITY|||||||0.4876|||||||Chi-squared|||At Outcome Assessment Visit||||0.4876
91738223|NCT01595529|183369011|SUPERIORITY|||||||0.4184|||||||Chi-squared|||At Test of Cure Visit||||0.4184
91738224|NCT01595529|183369011|SUPERIORITY|||||||0.9782|||||||Chi-squared|||At Outcome Assessment Visit||||0.9782
91738225|NCT01595529|183369012|SUPERIORITY||Risk Difference (RD)|-0.05277|||||TWO_SIDED|95.0|-0.08857|-0.01698||||||||-0.01698|-0.08857|
91738226|NCT01595529|183369013|SUPERIORITY||Risk Difference (RD)|-0.05664|||||TWO_SIDED|95.0|-0.09479|-0.0185||||||||-0.01850|-0.09479|
91738227|NCT01595529|183369014|SUPERIORITY||Risk Difference (RD)|-0.03056|||||TWO_SIDED|95.0|-0.07744|0.016323||||||||0.016323|-0.07744|
91738228|NCT01595529|183369015|SUPERIORITY||Risk Difference (RD)|-0.01094|||||TWO_SIDED|95.0|-0.058|0.036117||||||||0.036117|-0.0580|
91738229|NCT01595529|183369016|SUPERIORITY||Risk Difference (RD)|-0.10373|||||TWO_SIDED|95.0|-0.14161|-0.06585||||||||-0.06585|-0.14161|
91738230|NCT01595529|183369017|SUPERIORITY||Risk Difference (RD)|-0.09198|||||TWO_SIDED|95.0|-0.13006|-0.05391||||||||-0.05391|-0.13006|
91738231|NCT04016714|183369018|OTHER||Difference in percentage vs Prevenar 13™|-5.5|||=|0.05|TWO_SIDED|95.0|-11.0|0.0|||Miettinen & Nurminen method|||Injection-site erythema||0.0|-11.0|= 0.050
91738232|NCT04016714|183369018|OTHER||Difference in percentage vs Prevenar 13™|-2.1|||=|0.46|TWO_SIDED|95.0|-7.7|3.5|||Miettinen & Nurminen method|||Injection-site induration||3.5|-7.7|= 0.460
91738233|NCT04016714|183369018|OTHER||Difference in percentage vs Prevenar 13™|3.4|||=|0.225|TWO_SIDED|95.0|-2.1|8.9|||Miettinen & Nurminen method|||Injection-site pain||8.9|-2.1|= 0.225
91738234|NCT04016714|183369018|OTHER||Difference in percentage vs Prevenar 13™|2.3|||=|0.43|TWO_SIDED|95.0|-3.4|7.9|||Miettinen & Nurminen method|||Injection-site swelling||7.9|-3.4|= 0.430
91738235|NCT04016714|183369019|OTHER||Difference in percentage vs Prevenar 13™|-3.5|||=|0.229|TWO_SIDED|95.0|-9.1|2.2|||Miettinen & Nurminen method|||Decreased appetite||2.2|-9.1|= 0.229
91738236|NCT04016714|183369019|OTHER||Difference in percentage vs Prevenar 13™|2.2|||=|0.077|TWO_SIDED|95.0|-0.2|4.7|||Miettinen & Nurminen method|||Irritability||4.7|-0.2|= 0.077
91738237|NCT04016714|183369019|OTHER||Difference in percentage vs Prevenar 13™|-0.6|||=|0.793|TWO_SIDED|95.0|-5.4|4.1|||Miettinen & Nurminen method|||Somnolence||4.1|-5.4|= 0.793
91738238|NCT04016714|183369019|OTHER||Difference in percentage vs Prevenar 13™|-4.6|||=|0.045|TWO_SIDED|95.0|-9.1|-0.1|||Miettinen & Nurminen method|||Urticaria||-0.1|-9.1|= 0.045
91738239|NCT04016714|183369020|OTHER||Difference in percentage vs Prevenar 13™|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Vaccine-related SAEs||0.9|-0.9|
91498910|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
91738240|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% confidence interval (CI) for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.3|-0.6|||Miettinen & Nurminen method|||Serotype 1||-0.6|-4.3|< 0.001
91738241|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|10.5|||<|0.001|TWO_SIDED|95.0|6.6|14.6|||Miettinen & Nurminen method|||Serotype 3||14.6|6.6|< 0.001
91738242|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-1.9|||<|0.001|TWO_SIDED|95.0|-4.0|0.0|||Miettinen & Nurminen method|||Serotype 4||0.0|-4.0|< 0.001
91738243|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen method|||Serotype 5||0.8|-1.4|< 0.001
91738244|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.5|1.0|||Miettinen & Nurminen method|||Serotype 6A||1.0|-1.5|< 0.001
91738245|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-1.2|1.5|||Miettinen & Nurminen method|||Serotype 6B||1.5|-1.2|< 0.001
91738246|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.4|1.4|||Miettinen & Nurminen method|||Serotype 7F||1.4|-0.4|< 0.001
91498911|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.4|<.0001
91498912|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0031|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0031
91498913|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.5|<.0001
91498914|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
91498915|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.0117|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-0.9|0.0117
91498916|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
91498917|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
91498918|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0040
91498919|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.6|<.0001
91738247|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 9V||1.2|-0.8|< 0.001
91738248|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.7|0.7|||Miettinen & Nurminen method|||Serotype 14||0.7|-1.7|< 0.001
91738249|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.5|||Miettinen & Nurminen method|||Serotype 18C||1.5|-0.6|< 0.001
91738250|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.7|||Miettinen & Nurminen method|||Serotype 19A||0.7|-1.3|< 0.001
91738251|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 19F||1.2|-0.8|< 0.001
91738252|NCT04016714|183369021|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.9|||<|0.001|TWO_SIDED|95.0|-1.2|3.0|||Miettinen & Nurminen method|||Serotype 23F||3.0|-1.2|< 0.001
91738253|NCT04016714|183369021|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|94.0|||<|0.001|TWO_SIDED|95.0|91.6|95.8|||Miettinen & Nurminen method|||Serotype 22F||95.8|91.6|< 0.001
91738254|NCT04016714|183369021|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|97.2|||<|0.001|TWO_SIDED|95.0|95.4|98.4|||Miettinen & Nurminen method|||Serotype 33F||98.4|95.4|< 0.001
91738255|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.54|0.63|||t-test, 1 sided|||Serotype 1||0.63|0.54|< 0.001
91738256|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|1.31|||<|0.001|TWO_SIDED|95.0|1.2|1.43|||t-test, 1 sided|||Serotype 3||1.43|1.20|< 0.001
91738257|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided|||Serotype 4||0.78|0.63|< 0.001
91738258|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided|||Serotype 5||0.68|0.56|< 0.001
91738259|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.67|||t-test, 1 sided|||Serotype 6A||0.67|0.54|< 0.001
91738260|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||t-test, 1 sided|||Serotype 6B||1.00|0.79|< 0.001
91738261|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.81|||t-test, 1 sided|||Serotype 7F||0.81|0.69|< 0.001
91738262|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.64|0.76|||t-test, 1 sided|||Serotype 9V||0.76|0.64|< 0.001
91738263|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.87|||t-test, 1 sided|||Serotype 14||0.87|0.70|< 0.001
91738264|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.92|||t-test, 1 sided|||Serotype 18C||0.92|0.77|< 0.001
91738265|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.82|||t-test, 1 sided|||Serotype 19A||0.82|0.68|< 0.001
91738266|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.87|||t-test, 1 sided|||Serotype 19F||0.87|0.72|< 0.001
91738267|NCT04016714|183369022|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||t-test, 1 sided|||Serotype 23F||1.00|0.81|< 0.001
91738268|NCT04016714|183369022|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2- sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|68.34|||<|0.001|TWO_SIDED|95.0|61.73|75.65|||t-test, 1 sided|||Serotype 22F||75.65|61.73|< 0.001
91738269|NCT04016714|183369022|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|48.99|||<|0.001|TWO_SIDED|95.0|44.45|54.01|||t-test, 1 sided|||Serotype 33F||54.01|44.45|< 0.001
91738270|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Diphtheria toxoid||1.0|-0.6|< 0.001
91498920|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
91498921|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.01|TWO_SIDED|95.0|-1.0|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-1.0|0.0100
91704902|NCT03646305|183304390|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
91704903|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of confidence were equivalent across time.||||>0.05
91704904|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of confidence||||>0.05
91704905|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of confidence||||>0.05
91704906|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of confidence||||>0.05
91704907|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of confidence across time.||||>0.05
91738271|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Tetanus toxoid||1.0|-0.6|< 0.001
91738272|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - PT||1.0|-0.6|< 0.001
91530985|NCT04707391|182938292|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup W.|Difference in percentage of participants|1.6|||||TWO_SIDED|0.95|-2.73|4.89||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||4.89|-2.73|
91530986|NCT04707391|182938292|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup Y.|Difference in percentage of participants|0.6|||||TWO_SIDED|0.95|-3.93|3.91||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.91|-3.93|
91704908|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
91704909|NCT03646305|183304391|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
91704910|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, level of self-esteem were equivalent across time.||||<0.05
91704911|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in self-esteem from post-intervention to follow-up. Null hypothesis: there would be no significant differences in self-esteem from post-intervention to follow-up.||||<0.001
91704912|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of self-esteem||||>0.05
91704913|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of self-esteem||||>0.05
91738273|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - FHA||1.0|-0.6|< 0.001
91738274|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - FIM 2/3||1.2|-0.8|< 0.001
91738275|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - PRN||1.2|-0.8|< 0.001
91738276|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-1.1|||<|0.001|TWO_SIDED|95.0|-3.3|0.9|||Miettinen & Nurminen method|||Hib-PRP||0.9|-3.3|< 0.001
91738277|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-0.6|||<|0.001|TWO_SIDED|95.0|-2.0|0.5|||Miettinen & Nurminen method|||HBsAg||0.5|-2.0|< 0.001
91738278|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen method|||Poliovirus 1||0.9|-0.9|< 0.001
91738279|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.1|||Miettinen & Nurminen method|||Poliovirus 2||1.1|-0.6|< 0.001
91738280|NCT04016714|183369023|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.7|||Miettinen & Nurminen method|||Poliovirus 3||0.7|-0.8|< 0.001
91498922|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.5|<.0001
91738281|NCT04016714|183369025|OTHER||GMC ratio|0.82|||||TWO_SIDED|95.0|0.75|0.89||||||Serotype 1||0.89|0.75|
91738282|NCT04016714|183369025|OTHER||GMC ratio|1.81|||||TWO_SIDED|95.0|1.66|1.98||||||Serotype 3||1.98|1.66|
91498923|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.0006|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.2|0.0006
91738283|NCT04016714|183369025|OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Serotype 4||1.21|0.99|
91738284|NCT04016714|183369025|OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01||||||Serotype 5||1.01|0.81|
91738285|NCT04016714|183369025|OTHER||GMC ratio|0.44|||||TWO_SIDED|95.0|0.38|0.5||||||Serotype 6A||0.50|0.38|
91738286|NCT04016714|183369025|OTHER||GMC ratio|1.73|||||TWO_SIDED|95.0|1.46|2.05||||||Serotype 6B||2.05|1.46|
91738287|NCT04016714|183369025|OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.71|0.84||||||Serotype 7F||0.84|0.71|
91738288|NCT04016714|183369025|OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12||||||Serotype 9V||1.12|0.90|
91738289|NCT04016714|183369025|OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||Serotype 14||1.18|0.89|
91738290|NCT04016714|183369025|OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.68|0.82||||||Serotype 18C||0.82|0.68|
91738291|NCT04016714|183369025|OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81||||||Serotype 19A||0.81|0.64|
91738292|NCT04016714|183369025|OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.62|0.77||||||Serotype 19F||0.77|0.62|
91738293|NCT04016714|183369025|OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|1.16|1.51||||||Serotype 23F||1.51|1.16|
91530987|NCT04707391|182938293|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in the 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup A.|Difference in percentage of participants|-2.5|||||TWO_SIDED|0.95|-5.59|0.47||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||0.47|-5.59|
91738294|NCT04016714|183369025|SUPERIORITY||GMC ratio|81.01|||||TWO_SIDED|95.0|73.12|89.75||||||Serotype 22F||89.75|73.12|
91738295|NCT04016714|183369025|OTHER||GMC ratio|7.81|||||TWO_SIDED|95.0|6.82|8.94||||||Serotype 33F||8.94|6.82|
91738296|NCT01822665|183369028|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.63|-0.59||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.59|-1.63|<0.0001
91738297|NCT01822665|183369029|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.0095|TWO_SIDED|95.0|-1.23|-0.18|||t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.18|-1.23|0.0095
91738298|NCT01822665|183369029|SUPERIORITY_OR_OTHER||LS mean difference|0.19||||0.4794|TWO_SIDED|95.0|-0.34|0.72||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.72|-0.34|0.4794
91738299|NCT01822665|183369029|SUPERIORITY_OR_OTHER||LS mean difference|0.4||||0.1429|TWO_SIDED|95.0|-0.14|0.95||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.95|-0.14|0.1429
91738300|NCT01822665|183369029|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.75|1.84||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.84|0.75|<0.0001
91738301|NCT01822665|183369029|SUPERIORITY_OR_OTHER||LS mean difference|0.89||||0.002|TWO_SIDED|95.0|0.34|1.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.45|0.34|0.0020
91738302|NCT01822665|183369030|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.6497|TWO_SIDED|95.0|-0.49|0.31||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.31|-0.49|0.6497
91738303|NCT01822665|183369030|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.7591|TWO_SIDED|95.0|-0.46|0.34||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.34|-0.46|0.7591
91738304|NCT01822665|183369030|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4126|TWO_SIDED|95.0|-0.24|0.57||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.57|-0.24|0.4126
91738305|NCT01822665|183369030|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8903|TWO_SIDED|95.0|-0.39|0.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.45|-0.39|0.8903
91738306|NCT01822665|183369030|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.2227|TWO_SIDED|95.0|-0.16|0.67||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.67|-0.16|0.2227
91738307|NCT01822665|183369030|SUPERIORITY_OR_OTHER||LS mean difference|0.23||||0.2855|TWO_SIDED|95.0|-0.2|0.65||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.65|-0.20|0.2855
91738308|NCT01822665|183369031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.19||||0.0084|TWO_SIDED|95.0|1.6|23.97||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||23.97|1.60|0.0084
91738309|NCT01822665|183369031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19||||0.0999|TWO_SIDED|95.0|0.8|12.74||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||12.74|0.80|0.0999
91738310|NCT01822665|183369031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.2845|TWO_SIDED|95.0|0.58|6.5|||Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||6.50|0.58|0.2845
91738311|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.||||<0.001
91738312|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||mann whitney u to compare rosenberg score baseline to 1 hour||||<.001
91738313|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.001
91738314|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.001
91738315|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.001
91738316|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.01
91738317|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.01
91738318|NCT00867035|183369033|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.05
91738319|NCT00867035|183369034|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 hour analyzed between groups.||||>0.05
91738320|NCT00867035|183369035|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
91738321|NCT00867035|183369036|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 4 hours analyzed between groups||||>0.05
91738322|NCT00867035|183369037|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
91738323|NCT00867035|183369038|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 1 hour analyzed between groups||||>0.05
91738324|NCT00867035|183369039|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
91738325|NCT00867035|183369040|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
91738326|NCT00867035|183369041|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
91738327|NCT00867035|183369042|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groups||||>0.05
91738328|NCT00867035|183369043|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.||||>0.05
91738329|NCT04552041|183369048|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||<0.0001
91738330|NCT04552041|183369049|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||0.0028
91738331|NCT04552041|183369049|SUPERIORITY|||||||0.1739|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Delusional ideas ∆ between baseline and 24 weeks row."||||0.1739
91738332|NCT04552041|183369049|SUPERIORITY|||||||0.0559|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Hallucinations ∆ between baseline and 24 weeks row."||||0.0559
91738333|NCT04552041|183369049|SUPERIORITY|||||||0.0174|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Agitation ∆ between baseline and 24 weeks row."||||0.0174
91738334|NCT04552041|183369049|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aggression ∆ between baseline and 24 weeks row."||||0.3330
91738335|NCT04552041|183369049|SUPERIORITY|||||||0.1037|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Dysphoria ∆ between baseline and 24 weeks row."||||0.1037
91738336|NCT04552041|183369049|SUPERIORITY|||||||0.0329|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Anxiety ∆ between baseline and 24 weeks row."||||0.0329
91738337|NCT04552041|183369049|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Euphoria ∆ between baseline and 24 weeks row."||||0.2700
91738338|NCT04552041|183369049|SUPERIORITY|||||||0.0557|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Apathy ∆ between baseline and 24 weeks row."||||0.0557
91738339|NCT04552041|183369049|SUPERIORITY|||||||0.982|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Disinhibition ∆ between baseline and 24 weeks row."||||0.9820
91738340|NCT04552041|183369049|SUPERIORITY|||||||0.4626|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Irritability ∆ between baseline and 24 weeks row."||||0.4626
91738341|NCT04552041|183369049|SUPERIORITY|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant motor behaviour ∆ between baseline and 24 weeks row."||||0.0006
91738342|NCT04552041|183369049|SUPERIORITY|||||||0.3725|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Sleep disorders ∆ between baseline and 24 weeks row."||||0.3725
91738343|NCT04552041|183369049|SUPERIORITY|||||||0.1013|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Appetite disorders ∆ between baseline and 24 weeks row."||||0.1013
91738344|NCT04552041|183369049|SUPERIORITY|||||||0.0432|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant vocalizations ∆ between baseline and 24 weeks row."||||0.0432
91738345|NCT04552041|183369050|SUPERIORITY|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.0316
91738346|NCT04552041|183369051|SUPERIORITY|||||||0.1483|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.1483
91738347|NCT04552041|183369052|SUPERIORITY|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0018
91738348|NCT04552041|183369052|SUPERIORITY|||||||0.4733|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.4733
91738349|NCT04552041|183369052|SUPERIORITY|||||||0.0035|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0035
91738350|NCT01747915|183369071|SUPERIORITY||Least Square (LS) Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.088||0.8121|TWO_SIDED|95.0|-0.15|0.19|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.19|-0.15|0.8121
91738351|NCT01747915|183369071|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.8889|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.16|-0.19|0.8889
91738352|NCT01747915|183369072|SUPERIORITY||Odds Ratio (OR)|1.095||||0.7973|TWO_SIDED|95.0|0.548|2.186||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||2.186|0.548|0.7973
91738353|NCT01747915|183369072|SUPERIORITY||Odds Ratio (OR)|0.934||||0.8474|TWO_SIDED|95.0|0.465|1.877||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||1.877|0.465|0.8474
91738354|NCT00988156|183369073|SUPERIORITY_OR_OTHER|||||||0.249|||||||ANCOVA|||||||0.2490
91738355|NCT00988156|183369074|SUPERIORITY_OR_OTHER|||||||0.9017|||||||Cochran-Mantel-Haenszel|||||||0.9017
91738356|NCT02163577|183369156|SUPERIORITY||||||<|0.0001||||||Per generalized estimating equations (GEE) model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91738357|NCT02163577|183369156|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91738358|NCT02163577|183369156|SUPERIORITY||Difference in LS Means|-0.33|||||TWO_SIDED|95.0|-0.63|-0.04||||||Difference in change to Week 40||-0.04|-0.63|
91738359|NCT02163577|183369156|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738360|NCT02163577|183369156|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738361|NCT02163577|183369156|SUPERIORITY||Difference in LS Means|-0.16|||||TWO_SIDED|95.0|-0.45|0.13||||||Difference in change to Week 64||0.13|-0.45|
91738362|NCT02163577|183369156|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738363|NCT02163577|183369156|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738364|NCT02163577|183369157|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
91738365|NCT02163577|183369157|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
91738366|NCT02163577|183369157|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738367|NCT02163577|183369157|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738368|NCT02163577|183369157|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
91738369|NCT02163577|183369157|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
91738370|NCT02163577|183369158|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
91738371|NCT02163577|183369158|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
91738372|NCT02163577|183369158|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738373|NCT02163577|183369158|SUPERIORITY|||||||0.0024|||||||one sample t test|||Week 64||||0.0024
91738374|NCT02163577|183369158|SUPERIORITY|||||||0.0018|||||||one sample t test|||Week 160||||0.0018
91738375|NCT02163577|183369158|SUPERIORITY|||||||0.0002|||||||one sample t test|||Week 160||||0.0002
91738376|NCT02163577|183369159|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
91738377|NCT02163577|183369159|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
91738378|NCT02163577|183369159|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738379|NCT02163577|183369159|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738380|NCT02163577|183369159|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
91738381|NCT02163577|183369159|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
91530988|NCT04707391|182938293|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup C.|Difference in percentage of participants|0.1|||||TWO_SIDED|0.95|-2.76|2.94||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.94|-2.76|
91530989|NCT04707391|182938293|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup W.|Difference in percentage of participants|0.4|||||TWO_SIDED|0.95|-2.41|3.25||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.25|-2.41|
91530990|NCT04707391|182938293|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup Y.|Difference in percentage of participants|-0.8|||||TWO_SIDED|0.95|-3.62|2.09||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.09|-3.62|
91530991|NCT01406717|182938313|OTHER||ANCOVA|0.0002|||||TWO_SIDED|95.0|-0.31377|0.31418||||||||0.31418|-0.31377|
91530992|NCT01406717|182938314|OTHER||ANCOVA|5.898|||||TWO_SIDED|95.0|-6.7565|18.5535||||||||18.5535|-6.7565|
91530993|NCT01406717|182938315|OTHER||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91530994|NCT01406717|182938317|OTHER|||||||0.6318|||||||ANCOVA|||||||0.6318
91530995|NCT01406717|182938318|OTHER|||||||0.4887|||||||ANOVA|||||||0.4887
91530996|NCT01406717|182938319|OTHER|||||||0.3813|||||||ANOVA|||||||0.3813
91530997|NCT01406717|182938320|OTHER|||||||0.99|||||||ANOVA|||||||0.9900
91530998|NCT01406717|182938321|OTHER|||||||0.0017|||||||ANOVA|||||||0.0017
91530999|NCT01406717|182938322|OTHER|||||||0.6098|||||||Mantel Haenszel|||||||0.6098
91531000|NCT01406717|182938323|OTHER|||||||0.7324|||||||ANOVA|||||||0.7324
91531001|NCT01406717|182938324|OTHER|||||||0.2984|||||||ANOVA|||||||0.2984
91738382|NCT02163577|183369160|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738383|NCT02163577|183369160|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738384|NCT02163577|183369160|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91531002|NCT02040090|182938325|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We will reject the null hypothesis at the one-sided 5% significance level, and conclude that Cp \> -0.1, if the lower bound of an exact 90% binomial confidence interval (CI) exceeds0.1. A sample size of 53 in each group provides 80% power to reject the null hypothesis.|Mean Difference (Net)|-0.018|||||TWO_SIDED|90.0|-0.082|0.031||||||The null hypothesis was that Cp ≤ -0.1.||0.031|-0.082|
91531003|NCT02275533|182938340|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.38|TWO_SIDED|95.0|0.54|1.56||One-sided p-value|Log Rank|||||1.56|0.54|0.38
91738385|NCT02163577|183369160|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738386|NCT02163577|183369160|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738387|NCT02163577|183369160|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738388|NCT02163577|183369161|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738389|NCT02163577|183369161|SUPERIORITY|||||||0.0015||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||0.0015
91738390|NCT02163577|183369161|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738391|NCT02163577|183369161|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738392|NCT02163577|183369161|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91531004|NCT02275533|182938341|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.23|TWO_SIDED|95.0|0.4|1.51||One-sided p-value|Log Rank|||||1.51|0.40|0.23
91531005|NCT02275533|182938343|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91531006|NCT01168674|182938367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|STANDARD_DEVIATION|1.67||0.48|TWO_SIDED||||||Mixed Models Analysis||The report is of the mean MADRS difference between ziprasidone versus placebo after linear mixed regression, correcting for confounding effects of order of treatment as well as other identified potential confounders.|Linear mixed effects regression model||||0.48
91531007|NCT01556763|182938378|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.10
91738393|NCT02163577|183369161|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738394|NCT02163577|183369162|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738395|NCT02163577|183369162|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738396|NCT02163577|183369162|SUPERIORITY||Difference in LS Means|0.21|||||TWO_SIDED|95.0|-0.12|0.54||||||Difference in change to Week 40||0.54|-0.12|
91738397|NCT02163577|183369162|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738398|NCT02163577|183369162|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738399|NCT02163577|183369162|SUPERIORITY||Difference in LS Means|-0.02|||||TWO_SIDED|95.0|-0.34|0.29||||||Difference in change to Week 64||0.29|-0.34|
91738400|NCT02163577|183369162|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738401|NCT02163577|183369162|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738402|NCT02163577|183369163|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738403|NCT02163577|183369163|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91531008|NCT01556763|182938379|SUPERIORITY_OR_OTHER||||||=|0.07||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.07
91531009|NCT01556763|182938380|SUPERIORITY_OR_OTHER||||||=|0.02||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.02
91531010|NCT01556763|182938381|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.008
91531011|NCT02258464|182938382|OTHER||Hazard Ratio (Radium 223/Placebo)|0.745||||0.3339|TWO_SIDED|80.0|0.504|1.102||The SSE-FS was compared using a stratified log-rank test with a 2-sided alpha of 0.2|Log Rank|||The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group||1.102|0.504|0.3339
91738404|NCT02163577|183369163|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738405|NCT02163577|183369163|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738406|NCT02163577|183369163|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738407|NCT02163577|183369163|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738408|NCT02163577|183369164|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738409|NCT02163577|183369164|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
91738410|NCT02163577|183369164|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738411|NCT02163577|183369164|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738412|NCT02163577|183369164|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738413|NCT02163577|183369164|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738414|NCT02163577|183369165|SUPERIORITY|||||||0.0088|||||||one sample t-test|||Week 0 to Week 40||||0.0088
91738415|NCT02163577|183369165|SUPERIORITY|||||||0.465|||||||one sample t-test|||Week 0 to Week 40||||0.4650
91738416|NCT02163577|183369165|SUPERIORITY|||||||0.016|||||||one sample t test|||Week 0 to Week 64||||0.0160
91738417|NCT02163577|183369165|SUPERIORITY|||||||0.4114|||||||one sample t test|||Week 0 to Week 64||||0.4114
91738418|NCT02163577|183369165|SUPERIORITY|||||||0.5335|||||||one sample t test|||Week 64 to Week 112||||0.5335
91738419|NCT02163577|183369165|SUPERIORITY|||||||0.8606|||||||one sample t test|||Week 64 to Week 112||||0.8606
91738420|NCT02163577|183369165|SUPERIORITY|||||||0.1627|||||||one sample t test|||Week 112 to Week 160||||0.1627
91531012|NCT02258464|182938383|OTHER||Hazard ratio (Radium 223/Placebo)|0.888||||0.7259|TWO_SIDED|80.0|0.576|1.37|||Log Rank|||||1.370|0.576|0.7259
91738421|NCT02163577|183369165|SUPERIORITY|||||||0.4096|||||||one sample t test|||Week 112 to Week 160||||0.4096
91738422|NCT02163577|183369166|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91531013|NCT02258464|182938384|OTHER||Hazard ratio (Radium 223/Placebo)|0.932||||0.8785|TWO_SIDED|80.0|0.513|1.693|||Log Rank|||||1.693|0.513|0.8785
91738423|NCT02163577|183369166|SUPERIORITY|||||||0.0569||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||0.0569
91738424|NCT02163577|183369166|SUPERIORITY|||||||0.0002||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
91738425|NCT02163577|183369166|SUPERIORITY|||||||0.0456||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0456
91738426|NCT02163577|183369166|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738427|NCT02163577|183369166|SUPERIORITY|||||||0.0343||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||0.0343
91738428|NCT02163577|183369171|SUPERIORITY|||||||0.0771||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0771
91738429|NCT02163577|183369171|SUPERIORITY|||||||0.9098||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.9098
91738430|NCT02163577|183369171|SUPERIORITY|||||||0.0007||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0007
91738431|NCT02163577|183369171|SUPERIORITY|||||||0.0327||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0327
91738432|NCT02163577|183369171|SUPERIORITY|||||||0.1865||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.1865
91738433|NCT02163577|183369171|SUPERIORITY|||||||0.2654||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2654
91738434|NCT02163577|183369172|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91738435|NCT02163577|183369172|SUPERIORITY|||||||0.0144||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0144
91738436|NCT02163577|183369172|SUPERIORITY|||||||0.0384||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0384
91531014|NCT02258464|182938385|OTHER||Hazard ratio (Radium 223/Placebo)|0.824||||0.524|TWO_SIDED|80.0|0.556|1.22|||Log Rank|||||1.220|0.556|0.5240
91531015|NCT02258464|182938386|OTHER||Difference (Radium 223 - Placebo) %|11.8||||0.345|TWO_SIDED|80.0|-2.7|26.3|||Cochran-Mantel-Haenszel|||||26.3|-2.7|0.345
91531016|NCT02258464|182938387|OTHER||Hazard ratio (Radium 223/Placebo)|0.968||||0.9128|TWO_SIDED|80.0|0.657|1.425|||Log Rank|||||1.425|0.657|0.9128
91531017|NCT02258464|182938388|OTHER||Hazard ratio (Radium 223/Placebo)|1.023||||0.9227|TWO_SIDED|80.0|0.753|1.391|||Log Rank|||||1.391|0.753|0.9227
91738437|NCT02163577|183369172|SUPERIORITY|||||||0.0004||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0004
91738438|NCT02163577|183369172|SUPERIORITY|||||||0.9795||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.9795
91738439|NCT02163577|183369172|SUPERIORITY|||||||0.2082||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2082
91738440|NCT02163577|183369173|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91531018|NCT00932646|182938391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.139|0.205|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.205|0.139|<0.0001
91738441|NCT02163577|183369173|SUPERIORITY|||||||0.0251||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0251
91531019|NCT00932646|182938391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.14|0.208|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.208|0.140|<0.0001
91531020|NCT00932646|182938391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.124|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.124|<0.0001
91738442|NCT02163577|183369173|SUPERIORITY|||||||0.9124||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.9124
91738443|NCT02163577|183369173|SUPERIORITY|||||||0.0016||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0016
91738444|NCT02163577|183369173|SUPERIORITY|||||||0.5677||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.5677
91531021|NCT00932646|182938392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.114|0.176|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.114|<0.0001
91738445|NCT02163577|183369173|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738446|NCT02163577|183369174|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91738447|NCT02163577|183369174|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91738448|NCT02163577|183369174|SUPERIORITY|||||||0.0033||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0033
91738449|NCT02163577|183369174|SUPERIORITY|||||||0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0001
91738450|NCT02163577|183369174|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738451|NCT02163577|183369174|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738452|NCT02163577|183369175|SUPERIORITY|||||||0.0014||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0014
91738453|NCT02163577|183369175|SUPERIORITY|||||||0.0028||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0028
91738454|NCT02163577|183369175|SUPERIORITY|||||||0.0536||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0536
91738455|NCT02163577|183369175|SUPERIORITY|||||||0.0002||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
91738456|NCT02163577|183369175|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738457|NCT02163577|183369175|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738458|NCT02163577|183369176|SUPERIORITY|||||||0.223||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.2230
91738459|NCT02163577|183369176|SUPERIORITY|||||||0.1132||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.1132
91738460|NCT02163577|183369176|SUPERIORITY|||||||0.2558||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.2558
91738461|NCT02163577|183369176|SUPERIORITY|||||||0.0814||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0814
91738462|NCT02163577|183369176|SUPERIORITY|||||||0.0093||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.0093
91738463|NCT02163577|183369176|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738464|NCT02163577|183369177|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
91738465|NCT02163577|183369177|SUPERIORITY|||||||0.0006||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0006
91738466|NCT02163577|183369177|SUPERIORITY|||||||0.026||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0260
91738467|NCT02163577|183369177|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
91738468|NCT02163577|183369177|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738469|NCT02163577|183369177|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
91738470|NCT02163577|183369181|SUPERIORITY|||||||0.0003|||||||one sample t test|||Week 40||||0.0003
91738471|NCT02163577|183369181|SUPERIORITY|||||||0.0021|||||||one sample t test|||Week 40||||0.0021
91738472|NCT02163577|183369181|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738473|NCT02163577|183369181|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
91738474|NCT02163577|183369181|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
91738475|NCT02163577|183369181|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
91738476|NCT01343888|183369185|SUPERIORITY_OR_OTHER||Koch's method|27.5|||<|0.0001|TWO_SIDED|95.0|17.9|37.0||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.0|17.9|<0.0001
91738477|NCT01343888|183369185|SUPERIORITY_OR_OTHER||Koch's methond|28.6|||<|0.0001|TWO_SIDED|95.0|19.0|38.2||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||38.2|19.0|<0.0001
91738478|NCT01343888|183369185|SUPERIORITY_OR_OTHER||Koch's method|-1.0|||||TWO_SIDED|95.0|-7.9|5.8|||||adjusted for genotype and race using Koch's method, with continuity correction|||5.8|-7.9|
91531022|NCT00932646|182938392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.116|0.179|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.179|0.116|<0.0001
91738479|NCT01343888|183369186|SUPERIORITY_OR_OTHER||Koch's method|27.1|||<|0.0001|TWO_SIDED|95.0|17.5|36.7||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||36.7|17.5|<0.0001
91738480|NCT01343888|183369186|SUPERIORITY_OR_OTHER||Koch's method|27.8|||<|0.0001|TWO_SIDED|95.0|18.2|37.4||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.4|18.2|<0.0001
91738481|NCT01343888|183369186|SUPERIORITY_OR_OTHER||Koch's method|-0.6|||||TWO_SIDED|95.0|-7.6|6.3|||||adjusted for genotype and race using Koch's method, with continuity correction|||6.3|-7.6|
91738482|NCT01990742|183369203|OTHER||||||>|0.05|||||||MOnte carlo simulation|||||||>0.05
91738483|NCT01990742|183369204|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
91738484|NCT01990742|183369205|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
91738485|NCT01103414|183369208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|STANDARD_ERROR_OF_MEAN|6.77||0.1819|TWO_SIDED|95.0|-22.4|4.3|||ANCOVA|||||4.3|-22.4|0.1819
91738486|NCT01103414|183369208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.4|STANDARD_ERROR_OF_MEAN|6.59||0.0057|TWO_SIDED|95.0|-31.4|-5.4|||ANCOVA|||||-5.4|-31.4|0.0057
91738487|NCT01103414|183369208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.9|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|-42.3|-15.6|||ANCOVA|||||-15.6|-42.3|<0.0001
91738488|NCT01103414|183369208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|-43.8|-18.2|||ANCOVA|||||-18.2|-43.8|<0.0001
91738489|NCT01103414|183369209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0273|TWO_SIDED|95.0|-0.73|-0.04|||ANCOVA|||||-0.04|-0.73|0.0273
91738490|NCT01103414|183369209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.13|-0.45|||ANCOVA|||||-0.45|-1.13|<0.0001
91738491|NCT01103414|183369209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.21|-0.52|||ANCOVA|||||-0.52|-1.21|<0.0001
91738492|NCT01103414|183369209|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.98|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||ANCOVA|||||-0.65|-1.32|<0.0001
91738493|NCT03273907|183369230|SUPERIORITY|The primary null hypothesis tested was that the observed rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability is greater than or equal to the performance target rate of 7.00 percent.||||||0.187|||||||Exact one-sided binomial test|P-value is provided from exact one-sided binomial test with type I error 0.05 comparing CyPass System with performance criterion of 7.00 percent.||||||0.1870
91738494|NCT00110214|183369237|NON_INFERIORITY_OR_EQUIVALENCE|Superiority and futility analyses were conducted for the OS end point. The Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain the overall significance level of alpha=0.05 while conducting interim analyses on OS. The final analysis was performed when 748 deaths had been observed. An intention-to-treat approach was used in the analysis for all the clinical end points with the exception of toxicity.|Hazard Ratio (HR)|0.91||||0.181|TWO_SIDED|95.0|0.7|1.05||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||1.05|0.7|0.181
91738495|NCT00110214|183369238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91738496|NCT00110214|183369239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.001|TWO_SIDED|95.0|0.71|0.91||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||0.91|0.71|<0.001
91738497|NCT04577781|183369276|SUPERIORITY||Least Squares (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.353||0.885|TWO_SIDED|90.0|-0.66|0.55||Mixed model repeated measure (MMRM) with treatment-by-visit interaction and baseline-by-visit interaction as fixed effects (with an unstructured variance-covariance matrix).|MMRM|||||0.55|-0.66|0.885
91498924|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||0.0|-0.8|0.0690
91738498|NCT01911260|183369293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Growth Deficit who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
91738499|NCT01911260|183369293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Normal Height who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
91738500|NCT01657305|183369294|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.~Negative values for the intra-individual time difference indicate faster healing of the Oleogel-S10-treated wound half.~For right-censored observations (no wound closure observed in blinded photo evaluation), wound closure was conservatively calculated as +1 day after the last photo."||||<0.0001
91738501|NCT01657305|183369298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|13.4|<|0.0001|TWO_SIDED|95.0|6.0|11.2||Day 7|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.2|6.0|<0.0001
91738502|NCT01657305|183369298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|6.9|13.4||Day 10|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||13.4|6.9|<0.0001
91738503|NCT01657305|183369298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|4.6|11.1||Day 14|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.1|4.6|<0.0001
91738504|NCT01657305|183369298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|3.9|10.9||Day 18|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||10.9|3.9|<0.0001
91738505|NCT01657305|183369298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_DEVIATION|14.1|<|0.0001|TWO_SIDED|95.0|3.7|9.1||Day 21|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||9.1|3.7|<0.0001
91738506|NCT01657305|183369298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|12.9|=|0.0021|TWO_SIDED|95.0|1.5|6.4||Day 28|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||6.4|1.5|=0.0021
91738507|NCT00940602|183369314|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.636||||0.015|TWO_SIDED|95.0|0.42|0.96||Exploratory p-value is one tailed and is based on the stratified log-rank test.|Regression, Cox||95% CI was based on a Wald test from Cox model|||0.96|0.42|0.015
91738508|NCT00940602|183369315|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|12.0|||||TWO_SIDED|95.0|-1.8|25.7||||||||25.7|-1.8|
91738509|NCT00940602|183369316|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.832||||0.2|TWO_SIDED|95.0|0.54|1.28|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.28|0.54|0.200
91738510|NCT00940602|183369317|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-5.3|8.1||||||||8.1|-5.3|
91738511|NCT00940602|183369318|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-0.3|||||TWO_SIDED|95.0|-12.0|11.4||||||||11.4|-12.0|
91738512|NCT00940602|183369319|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.725||||0.184|TWO_SIDED|95.0|0.36|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.36|0.184
91498925|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
91738513|NCT00940602|183369320|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.195|||<|0.001|TWO_SIDED|95.0|0.11|0.36|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||0.36|0.11|<.001
91738514|NCT00940602|183369321|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.871||||0.303|TWO_SIDED|95.0|0.52|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.52|0.303
91738515|NCT00940602|183369322|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|1.072||||0.389|TWO_SIDED|95.0|0.66|1.75|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.75|0.66|0.389
91738516|NCT00940602|183369324|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.5|||||TWO_SIDED|95.0|-5.2|8.1||||||||8.1|-5.2|
91738517|NCT00940602|183369325|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|0.7|||||TWO_SIDED|95.0|-1.6|3.0||||||||3.0|-1.6|
91738518|NCT00940602|183369326|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-11.9|14.6||||||||14.6|-11.9|
91738519|NCT00940602|183369327|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-9.6|||||TWO_SIDED|95.0|-20.8|1.6||||||||1.6|-20.8|
91498926|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
91738520|NCT00940602|183369328|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.797||||0.232|TWO_SIDED|95.0|0.43|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.43|0.232
91738521|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Comparison among three groups over 4 weeks of treatment||||0.238
91738522|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.004|||||||Kruskal-Wallis|||Comparison among three groups at the 4th week of follow-up||||0.004
91738523|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.277|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.277
91738524|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.001
91738525|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.055|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.055
91738526|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison among three groups at the 12th week of follow-up||||0.001
91498927|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0054
91738527|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.33|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.330
91738528|NCT00508482|183369347|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||<0.001
91738529|NCT00508482|183369347|SUPERIORITY_OR_OTHER|||||||0.018|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.018
91738530|NCT00508482|183369348|SUPERIORITY_OR_OTHER|||||||0.573|||||||ANOVA|||||||0.573
91738531|NCT00508482|183369349|SUPERIORITY_OR_OTHER|||||||0.271|||||||Kruskal-Wallis|||||||0.271
91738532|NCT00508482|183369350|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91738533|NCT00508482|183369350|SUPERIORITY_OR_OTHER|||||||0.58|||||||Least-Significant Difference|||||||0.580
91738534|NCT00508482|183369350|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
91738535|NCT00508482|183369350|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
91738536|NCT00508482|183369351|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANOVA|||||||0.167
91738537|NCT00508482|183369352|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
91738538|NCT00508482|183369353|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91738539|NCT00508482|183369353|SUPERIORITY_OR_OTHER|||||||0.024|||||||Least-Significant Difference|||||||0.024
91738540|NCT00508482|183369353|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
91738541|NCT00508482|183369353|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
91738542|NCT00508482|183369354|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91738543|NCT00508482|183369354|SUPERIORITY_OR_OTHER|||||||0.627||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.627
91738544|NCT00508482|183369354|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
91738545|NCT00508482|183369354|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
91738546|NCT00508482|183369355|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91738547|NCT00508482|183369355|SUPERIORITY_OR_OTHER|||||||0.587||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.587
91738548|NCT00508482|183369355|SUPERIORITY_OR_OTHER|||||||0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.001
91738549|NCT00508482|183369355|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
91738550|NCT00508482|183369356|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
91738551|NCT00508482|183369356|SUPERIORITY_OR_OTHER|||||||0.507||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.507
91738552|NCT00508482|183369356|SUPERIORITY_OR_OTHER|||||||0.005||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.005
91738553|NCT00508482|183369356|SUPERIORITY_OR_OTHER|||||||0.008||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.008
91738554|NCT01374425|183369357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0555|TWO_SIDED|95.0|0.61|1.01||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||Hazard ratio (HR) (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low excision repair cross-complementing (ERCC)-1 level and region of enrollment.||1.01|0.61|0.0555
91738555|NCT01374425|183369358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3944|TWO_SIDED|95.0|0.56|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.56|0.3944
91738556|NCT01374425|183369359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0786|TWO_SIDED|95.0|0.55|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.55|0.0786
91738557|NCT01374425|183369360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9576|TWO_SIDED|95.0|0.77|1.28||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.77|0.9576
91738558|NCT01374425|183369361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.1658|TWO_SIDED|95.0|0.93|1.53||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.53|0.93|0.1658
91738559|NCT01374425|183369362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.3019|TWO_SIDED|95.0|0.41|1.32||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.32|0.41|0.3019
91738560|NCT01374425|183369363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6035|TWO_SIDED|95.0|0.48|1.53||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.53|0.48|0.6035
91738561|NCT01374425|183369364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4032|TWO_SIDED|95.0|0.54|1.28||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.54|0.4032
91704914|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions have equivalent levels of self-esteem||||>0.05
91704915|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent levels of self-esteem across time.||||>0.05
91704916|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of self-esteem||||>0.05
91704917|NCT03646305|183304392|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of self-esteem||||>0.05
91704918|NCT03646305|183304393|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between intervention and each outcome measure. Null: homework adherence does not mediate any relationships between intervention condition and outcome measures.||||>0.05
91704919|NCT03646305|183304393|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between activity and each outcome measure. Null: homework adherence does not mediate any relationships between activity condition and outcome measures.||||>0.05
91704920|NCT03646305|183304394|OTHER|Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures.|||||<|0.001||||||No other outcome measure was moderated by thought-shape fusion scores.|Moderation Analyses|||All moderation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 1, which includes one outcome variable, one predictor, and one moderator. Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures. Null: thought-shape fusion does not significantly moderate the relationship between intervention condition and state self-esteem||||<0.001
91704921|NCT01554176|183304395|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.679|TWO_SIDED|95.0|-3.8|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).||2.5|-3.8|0.679
91498928|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
91531023|NCT00932646|182938392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.125|0.187|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.187|0.125|<0.0001
91738562|NCT01374425|183369365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0647|TWO_SIDED|95.0|0.41|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.41|0.0647
91738563|NCT01374425|183369366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0861|TWO_SIDED|95.0|0.56|1.04||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.04|0.56|0.0861
91738564|NCT01374425|183369367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3295|TWO_SIDED|95.0|0.51|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.51|0.3295
91738565|NCT01374425|183369368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1519|TWO_SIDED|95.0|0.49|1.12||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.12|0.49|0.1519
91738566|NCT01374425|183369369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2774|TWO_SIDED|95.0|0.87|1.62||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.62|0.87|0.2774
91738567|NCT01374425|183369370|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|4.3|||||TWO_SIDED|95.0|-5.5|14.0|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.0|-5.5|
91738568|NCT01374425|183369371|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|9.4|||||TWO_SIDED|95.0|7.2|26.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||26.1|7.2|
91738569|NCT01374425|183369372|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|2.1|||||TWO_SIDED|95.0|-9.9|14.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.1|-9.9|
91738570|NCT01374425|183369373|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-3.7|||||TWO_SIDED|95.0|-14.0|6.6|||||The difference was calculated as the percentage of participants with objective response in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||6.6|-14.0|
91738571|NCT01374425|183369374|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.1|||||TWO_SIDED|95.0|-7.6|3.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-7.6|
91738572|NCT01374425|183369375|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-8.7|||||TWO_SIDED|95.0|-19.1|1.7|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||1.7|-19.1|
91738573|NCT01374425|183369376|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.3|||||TWO_SIDED|95.0|-3.7|8.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||8.3|-3.7|
91738574|NCT01374425|183369377|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-4.5|||||TWO_SIDED|95.0|-10.6|1.5|||||The difference was calculated as the percentage of participants with disease control in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||1.5|-10.6|
91738575|NCT01374425|183369378|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.0|||||TWO_SIDED|95.0|-15.9|7.8|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||7.8|-15.9|
91738576|NCT01374425|183369379|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-6.5|||||TWO_SIDED|95.0|-16.3|3.3|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-16.3|
91738577|NCT01374425|183369380|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
91738578|NCT01374425|183369381|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
91738579|NCT01374425|183369382|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.0|||||TWO_SIDED|95.0|-10.1|4.2|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||4.2|-10.1|
91738580|NCT01374425|183369383|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-5.5|||||TWO_SIDED|95.0|-11.5|0.4|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||0.4|-11.5|
91738581|NCT01374425|183369384|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.4|||||TWO_SIDED|95.0|-9.5|0.6|||||The difference was calculated as the percentage of participants with resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||0.6|-9.5|
91738582|NCT01374425|183369385|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-1.6|||||TWO_SIDED|95.0|-6.2|3.1|||||The difference was calculated as the percentage of participants with complete resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.1|-6.2|
91738583|NCT01374425|183369386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0593|TWO_SIDED|95.0|0.99|1.69||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.69|0.99|0.0593
91738584|NCT01374425|183369387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.2|2.24||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||2.24|1.20|0.0020
91738585|NCT01374425|183369388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.0955|TWO_SIDED|95.0|0.95|1.88||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.88|0.95|0.0955
91738586|NCT01374425|183369389|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.9|||||TWO_SIDED|95.0|-15.7|3.8|||||The difference was calculated as the percentage of participants with objective response in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.8|-15.7|
91704922|NCT01554176|183304396|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.82|TWO_SIDED|95.0|-3.2|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||2.5|-3.2|0.820
91738587|NCT01374425|183369390|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.4|||||TWO_SIDED|95.0|-16.0|5.2|||||The difference was calculated as the percentage of participants with objective response in the KRAS Mutant subgroup minus the KRAS Wild-Type subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||5.2|-16.0|
91738588|NCT01374425|183369391|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-1.1|||||TWO_SIDED|95.0|-6.5|4.3|||||The difference was calculated as the percentage of participants with disease control in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||4.3|-6.5|
91498929|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.3|<.0001
91704923|NCT01554176|183304397|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.701|TWO_SIDED|95.0|-1.9|1.3||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||1.3|-1.9|0.701
91738589|NCT01374425|183369392|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.2|||||TWO_SIDED|95.0|-8.6|2.1|||||The difference was calculated as the percentage of participants with resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||2.1|-8.6|
91738590|NCT01374425|183369393|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-4.9|||||TWO_SIDED|95.0|-9.6|-0.2|||||The difference was calculated as the percentage of participants with complete resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||-0.2|-9.6|
91738591|NCT02289469|183369394|SUPERIORITY||Mean Difference (Final Values)|23.8|||<|0.0001|TWO_SIDED|95.0|16.0|31.6|||Chi-squared|||A chi-square test was used to test for differences in proportions between intervention and control groups.||31.6|16.0|<0.0001
91738592|NCT02289469|183369395|OTHER||||||<|0.01|||||||Other|||Descriptive statistics (counts, frequencies) were used to summarize responses.||||<0.01
91738593|NCT01227057|183369396|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.029||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.029
91738594|NCT01227057|183369397|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.04||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.04
91738595|NCT01227057|183369398|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.|||||>|0.1||||||P value is for the group x time interaction.|ANOVA|||||||>.1
91738596|NCT01044030|183369424|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Chi-squared|||||||0.6
91738597|NCT00114127|183369469|SUPERIORITY_OR_OTHER||||||<|0.132||95.0|||||t-test, 2 sided|||||||<0.132
91738598|NCT00114127|183369470|SUPERIORITY_OR_OTHER||||||<|0.292||95.0|||||t-test, 2 sided|||||||<.292
91738599|NCT00539240|183369499|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
91738600|NCT00539240|183369499|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
91738601|NCT00539240|183369500|SUPERIORITY_OR_OTHER|||||||0.19||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons (no post-hoc contrasts performed)|ANCOVA|Adjusted for baseline score and personality traits (SCL-90)||||||0.19
91738602|NCT00539240|183369501|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.04
91738603|NCT00539240|183369501|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, no adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
91738604|NCT00539240|183369502|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
91738605|NCT00539240|183369502|SUPERIORITY_OR_OTHER|||||||0.2||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.20
91738606|NCT02629861|183369546|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91738607|NCT02629861|183369546|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91738608|NCT02629861|183369548|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
91738609|NCT02629861|183369548|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
91738610|NCT02629861|183369548|SUPERIORITY|||||||0.0032||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0032
91738611|NCT02629861|183369548|SUPERIORITY|||||||0.001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0010
91738612|NCT02629861|183369548|SUPERIORITY|||||||0.0048||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0048
91738613|NCT02629861|183369548|SUPERIORITY|||||||0.0003||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0003
91738614|NCT02629861|183369548|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
91704924|NCT01554176|183304398|SUPERIORITY_OR_OTHER||Estimated Odds Ratio|2.5||||0.0965|TWO_SIDED|95.0|0.8|7.3||Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.|Generalized Linear Mixed Effects Model|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||7.3|0.8|0.0965
91704925|NCT01554176|183304399|SUPERIORITY_OR_OTHER||Difference in percentage incidence|15.6|||||TWO_SIDED|95.0|-0.9|31.4||||Between-group comparison of AE incident rate||Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.||31.4|-0.9|
91738615|NCT02629861|183369548|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
91738616|NCT02629861|183369549|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
91738617|NCT02629861|183369549|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
91738618|NCT02629861|183369550|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
91738619|NCT02629861|183369550|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
91738620|NCT02629861|183369551|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
91738621|NCT02629861|183369551|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
91738622|NCT02629861|183369552|SUPERIORITY|||||||0.0023||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0023
91738623|NCT02629861|183369552|SUPERIORITY|||||||0.0021||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0021
91531024|NCT00932646|182938393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.149|0.223|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.223|0.149|<0.0001
91704926|NCT01554176|183304400|SUPERIORITY_OR_OTHER||Difference in percentage incidence|0.0|||||TWO_SIDED|95.0|-7.0|7.0||||Between-group comparison of incidence rate of drug discontinuation due to AE||Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).||7|-7|
91704927|NCT02436031|183304403|OTHER|||||||0.049|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||0.049
91704928|NCT02436031|183304403|OTHER|||||||0.135|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.135
91704929|NCT03816644|183304412|SUPERIORITY||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|2.32|5.07||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in dementia care outcomes between the intervention and control groups at 90 days post screening visit. Models are adjusted for age, sex, and years of education.||5.07|2.32|
91738624|NCT02525679|183369561|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.5968|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|1.3784|1.8151|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.8151|1.3784|
91738625|NCT02525679|183369561|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0207|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|0.9668|1.0747|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.0747|0.9668|
91738626|NCT02525679|183369563|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.7123|STANDARD_ERROR_OF_MEAN|0.2525|||TWO_SIDED|95.0|2.1856|3.2389|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||3.2389|2.1856|
91704930|NCT03816644|183304413|SUPERIORITY||Odds Ratio (OR)|1.133|||||TWO_SIDED|95.0|0.837|1.534||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in participants who were hospitalized or visited an ER 6 months post screening visit.||1.534|0.837|
91704931|NCT01760447|183304490|SUPERIORITY||Least Squares Mean Difference|-0.49|||=|0.018|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-0.09|-0.90|= 0.018
91704932|NCT01760447|183304491|OTHER||Difference in Percentage|-1.3|||||TWO_SIDED|95.0|-13.9|11.3|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||11.3|-13.9|
91704933|NCT01760447|183304492|OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-6.2|5.0|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.0|-6.2|
91704934|NCT01760447|183304493|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-8.9|14.4|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||14.4|-8.9|
91704935|NCT01760447|183304494|OTHER||Difference in Percentage|-2.1|||||TWO_SIDED|95.0|-10.1|5.8|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.8|-10.1|
91704936|NCT01760447|183304496|SUPERIORITY||Least Squares Mean Difference|-10.8|||=|0.159|TWO_SIDED|95.0|-25.9|4.3|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||4.3|-25.9|= 0.159
91704937|NCT01760447|183304498|SUPERIORITY||Difference in Percentage|16.0||||0.017|TWO_SIDED|95.0|2.9|28.9|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<7.0%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||28.9|2.9|0.017
91704938|NCT01760447|183304499|SUPERIORITY||Difference in Percentage|12.2||||0.049|TWO_SIDED|95.0|0.0|24.8|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<6.5%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||24.8|0.0|0.049
91704939|NCT01760447|183304502|SUPERIORITY||Kaplan-Meier Difference in Percentage|-13.2||||0.002|TWO_SIDED|95.0|-21.1|-5.3|||Log-Rank Test|||"The percentage of participants initiating glycemic rescue therapy in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-5.3|-21.1|0.002
91704940|NCT01937884|183304579|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91704941|NCT01937884|183304580|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91704942|NCT01937884|183304581|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|Student's t-test on log-transformed change in IFABP.||||||0.27
91704943|NCT01937884|183304582|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|Student's t-test on log-transformed citrulline concentration on study day 5, by treatment group||||||0.04
91704944|NCT01937884|183304583|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|Student's t-test on log-transformed percent change of claudin 3||||||0.43
91704945|NCT01937884|183304584|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91704946|NCT01937884|183304585|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
91704947|NCT01937884|183304586|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
91704948|NCT03706469|183304587|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of Geometric Mean Ratio (GMR)|83.6|||||TWO_SIDED|90.0|74.5|93.8||||||||93.80|74.50|
91704949|NCT03706469|183304587|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|102.22|||||TWO_SIDED|90.0|91.1|114.7||||||||114.70|91.10|
91704950|NCT03706469|183304587|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.73|||||TWO_SIDED|90.0|152.55|195.58||||||||195.58|152.55|
91704951|NCT03706469|183304588|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|84.29|||||TWO_SIDED|90.0|73.92|96.11||||||||96.11|73.92|
91738627|NCT02525679|183369563|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0003|STANDARD_ERROR_OF_MEAN|0.0253|||TWO_SIDED|95.0|0.9482|1.0525|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||1.0525|0.9482|
91738628|NCT00271544|183369564|SUPERIORITY_OR_OTHER||One sample proportion|0.955||||||95.0|0.92|0.955|||||1-side 95% confidence limit lower bound|||0.955|0.92|
91738629|NCT00271544|183369565|SUPERIORITY_OR_OTHER||One sample proportion|0.96||||||95.0|0.932|0.989||||||||0.989|0.932|
91738630|NCT00271544|183369566|SUPERIORITY_OR_OTHER||One sample mean|1.1|STANDARD_DEVIATION|0.9||||95.0|1.1|1.2|||||1-side 95% confidence limit upper bound|||1.2|1.1|
91738631|NCT00271544|183369567|SUPERIORITY_OR_OTHER||One sample mean|1.9|STANDARD_DEVIATION|2.0||||97.5|1.9|2.2|||||1-sided 97.5% confidence limit upper bound|||2.2|1.9|
91738632|NCT00271544|183369568|SUPERIORITY_OR_OTHER||One sample proportion|0.989||||||95.0|0.974|1.0||||||||1|0.974|
91738633|NCT00271544|183369569|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
91738634|NCT00271544|183369570|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
91738635|NCT01685684|183369583|SUPERIORITY_OR_OTHER_LEGACY||Marginal Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED||||||z-test|||||||<0.0001
91738636|NCT00902330|183369650|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.||||<0.05
91738637|NCT03571971|183369679|SUPERIORITY|Based on published data, we conservatively estimated that the standard exercise (SE) group and load modification (LM) group would have a 20% and 50% treatment success rate, respectively. We defined treatment success as either: 1) at least 'moderately better' on the Global Rating of Change scale or 2) ≥2 point decrease on the Numeric Pain Rating Scale. With one-side type I error=0.1, power=80%, and allocation ratio is 1:1, we estimated the need for 22 participants in each group (total N=44).|Odds Ratio (OR)|1.09||||0.879|TWO_SIDED|95.0|0.36|3.35||The a priori threshold for statistical significance was set at 0.05.|Chi-squared|||||3.35|0.36|0.879
91738638|NCT03950856|183369689|OTHER||Difference in Percentage|1.3||||0.538|TWO_SIDED|95.0|-3.3|4.8|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site erythema: V114 Combined Lots - Prevnar 13™||4.8|-3.3|0.538
91738639|NCT03950856|183369689|OTHER||Difference in Percentage|14.6|||<|0.001|TWO_SIDED|95.0|7.9|21.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site pain: V114 Combined Lots - Prevnar 13™||21.4|7.9|<0.001
91738640|NCT03950856|183369689|OTHER||Difference in Percentage|1.0||||0.686|TWO_SIDED|95.0|-4.3|5.3|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site swelling: V114 Combined Lots - Prevnar 13™||5.3|-4.3|0.686
91738641|NCT03950856|183369691|OTHER||Difference in Percentage|2.0||||0.272|TWO_SIDED|95.0|-1.9|4.7|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Arthralgia: V114 Combined Lots - Prevnar 13™||4.7|-1.9|0.272
91738642|NCT03950856|183369691|OTHER||Difference in Percentage|-0.7||||0.812|TWO_SIDED|95.0|-6.7|4.5|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Fatigue: V114 Combined Lots - Prevnar 13™||4.5|-6.7|0.812
91738643|NCT03950856|183369691|OTHER||Difference in Percentage|0.2||||0.947|TWO_SIDED|95.0|-5.6|5.0|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Headache: V114 Combined Lots - Prevnar 13™||5.0|-5.6|0.947
91738644|NCT03950856|183369691|OTHER||Difference in Percentage|5.2||||0.091|TWO_SIDED|95.0|-0.9|10.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Myalgia: V114 Combined Lots - Prevnar 13™||10.4|-0.9|0.091
91738645|NCT03950856|183369693|OTHER||Miettinen & Nurminen|0.0|||||TWO_SIDED|95.0|-1.6|0.2|||||V114 Combined Lots minus Prevnar 13™|V114 Combined Lots - Prevnar 13™||0.2|-1.6|
91738646|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.83|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.83|<0.001
91738647|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
91738648|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.88|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|<0.001
91738649|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.75|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.75|<0.001
91738650|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
91738651|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.95|<0.001
91738652|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.7|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.70|<0.001
91738653|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.85|<0.001
91738654|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.21|||<|0.001|TWO_SIDED|95.0|1.03|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.03|<0.001
91738655|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.7|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.70|<0.001
91738656|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.83|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.20|0.83|<0.001
91738657|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.98|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.42|0.98|<0.001
91738658|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
91738659|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
91498930|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65||||0.0036|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.1|0.0036
91498931|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.5|<.0001
91531025|NCT00932646|182938393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.162|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.162|<0.0001
91738660|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.85|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|<0.001
91531026|NCT00932646|182938393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.176|<0.0001
91531027|NCT00932646|182938394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.154|0.23|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.230|0.154|<0.0001
91704952|NCT03706469|183304588|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.61|||||TWO_SIDED|90.0|88.88|111.63||||||||111.63|88.88|
91704953|NCT03706469|183304588|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.7|||||TWO_SIDED|90.0|149.07|200.09||||||||200.09|149.07|
91704954|NCT03706469|183304589|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|79.14|||||TWO_SIDED|90.0|67.36|92.99||||||||92.99|67.36|
91704955|NCT03706469|183304589|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.8|||||TWO_SIDED|90.0|84.94|117.27||||||||117.27|84.94|
91704956|NCT03706469|183304589|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|173.3|||||TWO_SIDED|90.0|150.05|200.16||||||||200.16|150.05|
91704957|NCT00553358|183304592|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|-4.85||||0.3416|TWO_SIDED|97.5|-17.6|8.16|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1500 mg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm1 (Lapatinib 1500 mg) minus Arm2 (Trastuzumab 2 mg/kg).|||8.16|-17.6|0.3416
91704958|NCT00553358|183304592|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|21.79||||0.0001|TWO_SIDED|97.5|9.08|34.23|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg)|||34.23|9.08|0.0001
91704959|NCT00553358|183304600|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.548|TWO_SIDED|95.0|0.57|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.57|0.548
91704960|NCT00553358|183304600|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.005||||0.981|TWO_SIDED|95.0|0.66|1.52||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.52|0.66|0.981
91704961|NCT00553358|183304602|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.788||||0.379|TWO_SIDED|95.0|0.46|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.46|0.379
91704962|NCT00553358|183304602|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.962||||0.88|TWO_SIDED|95.0|0.58|1.6||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.60|0.58|0.880
91704963|NCT00553358|183304603|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.00079|TWO_SIDED|95.0|0.31|0.73|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the EFS landmark analysis||0.73|0.31|0.00079
91704964|NCT00553358|183304603|SUPERIORITY||Hazard Ratio (HR)|0.35||||0.004|TWO_SIDED|95.0|0.16|0.71|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib + trastuzumab arm||0.71|0.16|0.004
91531028|NCT00932646|182938394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.158|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.158|<0.0001
91531029|NCT00932646|182938394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.255|0.178|<0.0001
91531030|NCT00932646|182938395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.026||0.0003||95.0|0.045|0.148|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.045|0.0003
91531031|NCT00932646|182938395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026||0.0001||95.0|0.051|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.051|0.0001
91531032|NCT00932646|182938395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.026||0.0026||95.0|0.028|0.132|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.132|0.028|0.0026
91498932|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.1|<.0001
91498933|NCT00333866|182867855|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.0|<.0001
91498934|NCT00333866|182867856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.537|TWO_SIDED|95.0|0.71|1.95|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.95|0.71|0.5370
91498935|NCT00333866|182867856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0109|TWO_SIDED|95.0|1.16|3.18|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||3.18|1.16|0.0109
91498936|NCT00333866|182867856|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.9613|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.68|0.61|0.9613
91498937|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.71|||<|0.0001|TWO_SIDED|95.0|-17.56|-7.86|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-7.86|-17.56|<.0001
91498938|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.28|||<|0.0001|TWO_SIDED|95.0|-18.18|-8.38|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-8.38|-18.18|<.0001
91498939|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.2||||0.0038|TWO_SIDED|95.0|-12.06|-2.33|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.33|-12.06|0.0038
91498940|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.9||||0.0142|TWO_SIDED|95.0|1.19|10.61|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||10.61|1.19|0.0142
91498941|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.92||||0.0414|TWO_SIDED|95.0|0.19|9.66|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.66|0.19|0.0414
91498942|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.21||||0.6165|TWO_SIDED|95.0|-3.53|5.95|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.95|-3.53|0.6165
91498943|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.24||||0.0005|TWO_SIDED|95.0|-14.44|-4.05|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.05|-14.44|0.0005
91498944|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.92|||<|0.0001||95.0|-17.17|-6.68|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-6.68|-17.17|<.0001
91704965|NCT00553358|183304603|SUPERIORITY||Hazard Ratio (HR)|0.532||||0.134|TWO_SIDED|95.0|0.21|1.16|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib arm||1.16|0.21|0.134
91704966|NCT00553358|183304603|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.163|TWO_SIDED|95.0|0.28|1.2|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the trastuzumab arm||1.20|0.28|0.163
91498945|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.95||||0.0008|TWO_SIDED|95.0|-14.16|-3.74|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.74|-14.16|0.0008
91498946|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.0127|TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.64|0.08|0.0127
91498947|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.0005|TWO_SIDED|95.0|0.22|0.79|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.79|0.22|0.0005
91531033|NCT00932646|182938396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.195|0.306|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.306|0.195|<0.0001
91498948|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21||||0.1453|TWO_SIDED|95.0|-0.07|0.49|||ANCOVA|||Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.07|0.1453
91498949|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.34||||0.1033|TWO_SIDED|95.0|-0.88|9.57|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.57|-0.88|0.1033
91738661|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
91738662|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.86|<0.001
91738663|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.90|<0.001
91738664|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.72|0.93||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.93|0.72|<0.001
91738665|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.01||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.01|0.79|<0.001
91738666|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.96|<0.001
91738667|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.88|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|<0.001
91498950|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14||||0.0007|TWO_SIDED|95.0|3.88|14.41|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||14.41|3.88|0.0007
91531034|NCT00932646|182938396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.19|0.302|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.302|0.190|<0.0001
91531035|NCT00932646|182938396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.179|0.291|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.291|0.179|<0.0001
91738668|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.85|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.85|<0.001
91498951|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.56||||0.337|TWO_SIDED|95.0|-2.68|7.81|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.81|-2.68|0.3370
91738669|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|<0.001
91738670|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.81|<0.001
91738671|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.99|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|<0.001
91738672|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.05|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.05|<0.001
91738673|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.26|0.96|<0.001
91738674|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.0|1.31||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.31|1.00|<0.001
91738675|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|<0.001
91738676|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.79|<0.001
91738677|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|<0.001
91738678|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.95|<0.001
91498952|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.01||||0.3308|TWO_SIDED|95.0|-2.05|6.07|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.07|-2.05|0.3308
91531036|NCT00932646|182938397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.101|0.222|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.222|0.101|<0.0001
91531037|NCT00932646|182938397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.096|0.218|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.218|0.096|<0.0001
91704967|NCT00553358|183304605|SUPERIORITY||Hazard Ratio (HR)|0.366||||0.00041|TWO_SIDED|95.0|0.2|0.63|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the OS landmark analysis||0.63|0.20|0.00041
91498953|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7||||0.7364|TWO_SIDED|95.0|-3.39|4.8|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.80|-3.39|0.7364
91498954|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.76||||0.7132|TWO_SIDED|95.0|-3.31|4.84|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.84|-3.31|0.7132
91498955|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.9||||0.0002|TWO_SIDED|95.0|-10.54|-3.25|||ANCOVA|||Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.25|-10.54|0.0002
91498956|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.25|||<|0.0001|TWO_SIDED|95.0|-11.94|-4.55|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.55|-11.94|<.0001
91704968|NCT00553358|183304605|SUPERIORITY||Hazard Ratio (HR)|0.223||||0.002|TWO_SIDED|95.0|0.07|0.58|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib + trastuzumab arm||0.58|0.07|0.002
91704969|NCT00553358|183304605|SUPERIORITY||Hazard Ratio (HR)|0.433||||0.125|TWO_SIDED|95.0|0.12|1.17|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib arm||1.17|0.12|0.125
91704970|NCT00553358|183304605|SUPERIORITY||Hazard Ratio (HR)|0.414||||0.058|TWO_SIDED|95.0|0.15|1.0|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the trastuzumab arm||1.00|0.15|0.058
91704971|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.4|1.2||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.2|-3.4|
91704972|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.7|1.6||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-3.7|
91704973|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-2.3|2.4||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-2.3|
91704974|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.4|2.8||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-5.4|
91704975|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.3|2.6||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.6|-5.3|
91704976|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.7|4.7||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.7|-4.7|
91704977|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-2.7|1.6||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-2.7|
91704978|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-3.8|2.8||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-3.8|
91704979|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-4.3|2.5||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.5|-4.3|
91704980|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|1.2|||||TWO_SIDED|97.5|-1.6|4.5||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.5|-1.6|
91738679|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
91738680|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.82|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|<0.001
91738681|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|<0.001
91738682|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.77|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.77|<0.001
91738683|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
91738684|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.95|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.35|0.95|<0.001
91738685|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.81|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.81|<0.001
91738686|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|<0.001
91738687|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.88|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.21|0.88|<0.001
91498957|NCT00333866|182867857|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.36||||0.0197|TWO_SIDED|95.0|-8.02|-0.7|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.70|-8.02|0.0197
91704981|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.8|||||TWO_SIDED|97.5|-1.6|3.6||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.6|-1.6|
91704982|NCT01964716|183304642|SUPERIORITY_OR_OTHER||percentage difference|-0.4|||||TWO_SIDED|97.5|-4.4|3.5||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan \& Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.||3.5|-4.4|
91498958|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17||||0.3627|TWO_SIDED|95.0|-0.54|0.2|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.20|-0.54|0.3627
91738688|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.86|<0.001
91498959|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26||||0.1686|TWO_SIDED|95.0|-0.63|0.11|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.11|-0.63|0.1686
91531038|NCT00932646|182938397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.162|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.284|0.162|<0.0001
91738689|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.91|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.91|<0.001
91738690|NCT03950856|183369694|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|<0.001
91738691|NCT03950856|183369695|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 2|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
91738692|NCT03950856|183369695|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Lot 1 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.17|0.89|
91738693|NCT03950856|183369695|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
91738694|NCT03950856|183369695|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||Lot 1 divided by Lot 2|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.77|
91738695|NCT03950856|183369695|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||Lot 1 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.91|
91531039|NCT00932646|182938398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.155|0.258|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.258|0.155|<0.0001
91498960|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.3468|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-0.55|0.3468
91498961|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7147|TWO_SIDED|95.0|-0.71|0.49|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.71|0.7147
91498962|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63||||0.0409|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.03|-1.23|0.0409
91531040|NCT00932646|182938398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.15|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.150|<0.0001
91531041|NCT00932646|182938398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.176|0.281|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.281|0.176|<0.0001
91738696|NCT03950856|183369695|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.06|1.32|||||Lot 2 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.32|1.06|
91738697|NCT03950856|183369695|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.94|||||Lot 1 divided by Lot 2|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.72|
91738698|NCT03950856|183369695|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.23|||||Lot 1 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.94|
91738699|NCT03950856|183369695|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.5||||P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.50|1.14|
91498963|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04||||0.9077|TWO_SIDED|95.0|-0.56|0.63|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.63|-0.56|0.9077
91498964|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5923|TWO_SIDED|95.0|-0.64|0.37|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.37|-0.64|0.5923
91498965|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0174|TWO_SIDED|95.0|-1.12|-0.11|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.11|-1.12|0.0174
91498966|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16||||0.5408|TWO_SIDED|95.0|-0.66|0.35|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.66|0.5408
91498967|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.7236|TWO_SIDED|95.0|-0.57|0.4|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.40|-0.57|0.7236
91531042|NCT00932646|182938399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.233|0.365|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.365|0.233|<0.0001
91531043|NCT00932646|182938399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.236|0.369|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.369|0.236|<0.0001
91704983|NCT01964716|183304642|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.3|4.4||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.4|-4.3|
91738700|NCT03950856|183369695|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.95|||||Lot 1 divided by Lot 2|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.72|
91738701|NCT03950856|183369695|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11|||||Lot 1 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|
91738702|NCT03950856|183369695|OTHER||GMC Ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35|||||Lot 2 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.02|
91498968|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.71||||0.0045|TWO_SIDED|95.0|-1.19|-0.22|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.22|-1.19|0.0045
91704984|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.22||||||Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.87|
91738703|NCT03950856|183369695|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.07|||||Lot 1 divided by Lot 2|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.78|
91738704|NCT03950856|183369695|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||Lot 1 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|
91498969|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5613||95.0|-0.63|0.34|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.63|0.5613
91498970|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5609|TWO_SIDED|95.0|-0.6|0.33|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.33|-0.60|0.5609
91498971|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75||||0.0016|TWO_SIDED|95.0|-1.22|-0.28|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.28|-1.22|0.0016
91531044|NCT00932646|182938399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.271|0.405|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.405|0.271|<0.0001
91738705|NCT03950856|183369695|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.27|||||Lot 2 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.93|
91704985|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.79|||||TWO_SIDED|97.5|0.71|0.9||||||Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.90|0.71|
91704986|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.0|||||TWO_SIDED|97.5|0.86|1.18||||||Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.86|
91704987|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.85|1.19||||||Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.19|0.85|
91704988|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.86|1.22||||||Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.86|
91738706|NCT03950856|183369695|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||Lot 1 divided by Lot 2|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
91498972|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.3692|TWO_SIDED|95.0|-0.68|0.25|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.68|0.3692
91498973|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.3294|TWO_SIDED|95.0|-0.73|0.25|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.73|0.3294
91738707|NCT03950856|183369695|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
91531045|NCT00932646|182938400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.055||0.0163||95.0|0.024|0.239|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.239|0.024|0.0163
91498974|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.027|TWO_SIDED|95.0|-1.05|-0.06|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.06|-1.05|0.0270
91498975|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.8432|TWO_SIDED|95.0|-0.54|0.44|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.54|0.8432
91498976|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46||||0.0806|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.06|-0.98|0.0806
91531046|NCT00932646|182938400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.055||0.0118||95.0|0.031|0.247|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.031|0.0118
91738708|NCT03950856|183369695|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.94|1.28|||||Lot 2 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.28|0.94|
91738709|NCT03950856|183369695|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.92|||||Lot 1 divided by Lot 2|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.92|0.70|
91738710|NCT03950856|183369695|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
91738711|NCT03950856|183369695|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.04|1.37|||||Lot 2 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.37|1.04|
91738712|NCT03950856|183369695|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08|||l||Lot 1 divided by Lot 2|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.83|
91738713|NCT03950856|183369695|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||Lot 1 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
91498977|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.047|TWO_SIDED|95.0|-1.06|-0.01|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.01|-1.06|0.0470
91498978|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23||||0.3845|TWO_SIDED|95.0|-0.75|0.29|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-0.75|0.3845
91498979|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12||||0.6326|TWO_SIDED|95.0|-0.37|0.6|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.60|-0.37|0.6326
91704989|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.06|||||TWO_SIDED|97.5|0.82|1.36||||||Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.36|0.82|
91704990|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.94|||||TWO_SIDED|97.5|0.82|1.08||||||Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.82|
91704991|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.21||||||Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.21|0.87|
91704992|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.96|||||TWO_SIDED|97.5|0.75|1.24||||||Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.75|
91704993|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.28|||||TWO_SIDED|97.5|1.09|1.49||||||Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.49|1.09|
91704994|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.82|1.24||||||Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.82|
91704995|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.04|||||TWO_SIDED|97.5|0.85|1.26||||||Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.26|0.85|
91738714|NCT03950856|183369695|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.19|||||Lot 2 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|
91738715|NCT03950856|183369695|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0|||||Lot 1 divided by Lot 2|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.75|
91738716|NCT03950856|183369695|OTHER||GMC Ratio|1.13|||||TWO_SIDED|95.0|0.98|1.31|||||Lot 1 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.31|0.98|
91738717|NCT03950856|183369695|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.52|||||Lot 2 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.52|1.14|
91738718|NCT03950856|183369695|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|1.04|1.36|||||Lot 1 divided by Lot 2|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.36|1.04|
91738719|NCT03950856|183369695|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.15|1.51|||||Lot 1 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.15|
91738720|NCT03950856|183369695|OTHER||GMC Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.27|||||Lot 2 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.97|
91738721|NCT03950856|183369695|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||Lot 1 divided by Lot 2|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.02|0.78|
91498980|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22||||0.374|TWO_SIDED|95.0|-0.71|0.27|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.27|-0.71|0.3740
91498981|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03||||0.8936|TWO_SIDED|95.0|-0.45|0.52|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.52|-0.45|0.8936
91498982|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19||||0.4743|TWO_SIDED|95.0|-0.73|0.34|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.73|0.4743
91498983|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64||||0.0192|TWO_SIDED|95.0|-1.18|-0.1|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.10|-1.18|0.0192
91498984|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.5101|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.71|0.5101
91704996|NCT01964716|183304643|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.2|||||TWO_SIDED|97.5|0.98|1.48||||||Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.48|0.98|
91498985|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.4617|TWO_SIDED|95.0|-0.75|0.34|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.75|0.4617
91704997|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-7.7|||||TWO_SIDED|95.0|-17.2|1.9||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.9|-17.2|
91738722|NCT03950856|183369695|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||Lot 1 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.86|
91738723|NCT03950856|183369695|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.25|||||Lot 2 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.25|0.96|
91738724|NCT03950856|183369695|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|1.0|||||Lot 1 divided by Lot 2|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.76|
91738725|NCT03950856|183369695|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||Lot 1 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
91738726|NCT03950856|183369695|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
91738727|NCT03950856|183369695|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.07|||||Lot 1 divided by Lot 2|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.80|
91738728|NCT03950856|183369695|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Lot 1 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
91498986|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97||||0.0006|TWO_SIDED|95.0|-1.51|-0.42|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.42|-1.51|0.0006
91738729|NCT03950856|183369695|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||Lot 2 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.24|0.93|
91738730|NCT03950856|183369695|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||Lot 1 divided by Lot 2|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.81|
91738731|NCT03950856|183369695|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.26|||||Lot 1 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.26|0.93|
91738732|NCT03950856|183369695|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||Lot 2 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.00|
91498987|NCT00333866|182867858|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33||||0.229|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.21|-0.88|0.2290
91738733|NCT03950856|183369695|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||Lot 1 divided by Lot 2|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.06|0.79|
91738734|NCT03950856|183369695|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
91738735|NCT03950856|183369695|OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.99|1.34|||||Lot 2 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|
91738736|NCT03950856|183369696|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.62|0.91|||||V114 Combined Lots divided by Prevnar 13™|Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.91|0.62|
91738737|NCT03950856|183369696|OTHER||GMC Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||V114 Combined Lots divided by Prevnar 13™|Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.61|1.20|
91738738|NCT03950856|183369696|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||V114 Combined Lots divided by Prevnar 13™|Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.66|
91738739|NCT03950856|183369696|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||||V114 Combined Lots divided by Prevnar 13™|Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.74|
91738740|NCT03950856|183369696|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.43|0.95|
91738741|NCT03950856|183369696|OTHER||GMC Ratio|1.5|||||TWO_SIDED|95.0|1.21|1.86|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.86|1.21|
91738742|NCT03950856|183369696|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.73|
91738743|NCT03950856|183369696|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.72|
91738744|NCT03950856|183369696|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||||V114 Combined Lots divided by Prevnar 13™|Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.20|0.82|
91738745|NCT03950856|183369696|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.05|1.51|||||V114 Combined Lots divided by Prevnar 13™|Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.05|
91738746|NCT03950856|183369696|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.82|1.15|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.82|
91498988|NCT00333866|182867859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.42|TWO_SIDED|95.0|-4.95|2.06|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.06|-4.95|0.4200
91498989|NCT00333866|182867859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.85||||0.0012|TWO_SIDED|95.0|-9.38|-2.31|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.31|-9.38|0.0012
91704998|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-1.2|||||TWO_SIDED|95.0|-4.4|1.1||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.1|-4.4|
91704999|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
91705000|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-2.4|||||TWO_SIDED|95.0|-10.6|5.7||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||5.7|-10.6|
91738747|NCT03950856|183369696|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.86|1.23|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.86|
91738748|NCT03950856|183369696|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.03|1.54|||||V114 Combined Lots divided by Prevnar 13™|Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.54|1.03|
91738749|NCT03950856|183369696|OTHER||GMC Ratio|12.21|||||TWO_SIDED|95.0|10.11|14.74|||||V114 Combined Lots divided by Prevnar 13™|Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|14.74|10.11|
91738750|NCT03950856|183369696|OTHER||GMC Ratio|9.42|||||TWO_SIDED|95.0|7.96|11.13|||||V114 Combined Lots divided by Prevnar 13™|Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|11.13|7.96|
91738751|NCT04422431|183369715|OTHER|||||||0.1002|||||||t-test, 2 sided|||||||0.1002
91738752|NCT01174563|183369731|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.41|0.83|||Log Rank|||||0.83|0.41|0.005
91498990|NCT00333866|182867859|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17||||0.5126|TWO_SIDED|95.0|-4.68|2.34|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.34|-4.68|0.5126
91498991|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51||||0.7781|TWO_SIDED|95.0|-4.07|3.05|||ANCOVA|||Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.05|-4.07|0.7781
91705001|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.8||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-2.9|
91738753|NCT01347060|183369742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0051|TWO_SIDED|95.0|0.68|0.93||The P-value relates to differences in combined inpatient/emergency department.|Regression, Cox|Adjusted for baseline differences||||0.93|0.68|0.0051
91738754|NCT01347060|183369743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|883.23||||0.001|TWO_SIDED|95.0|731.66|1041.69||The P-value is on the adjusted difference in total asthma costs.|Regression, Linear|Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline||||1041.69|731.66|0.001
91738755|NCT01347060|183369744|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91738756|NCT00444106|183369745|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sided exact test for a single propn.|One-sided exact test for a single proportion.||"One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.~Increase in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms."||||<.0001
91738757|NCT02896257|183369762|SUPERIORITY||Odds Ratio (OR)|3.66|||<|0.001|TWO_SIDED|95.0|2.5|5.38|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||5.38|2.50|<0.001
91738758|NCT02896257|183369763|SUPERIORITY||Odds Ratio (OR)|0.8||||0.47|TWO_SIDED|95.0|0.44|1.47|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.47|0.44|0.47
91738759|NCT02896257|183369764|SUPERIORITY||Odds Ratio (OR)|0.63||||0.42|TWO_SIDED|95.0|0.2|1.96|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.96|0.20|0.42
91759509|NCT02391363|183411760|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
91759510|NCT02391363|183411761|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
91498992|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.2792|TWO_SIDED|95.0|-1.62|5.59|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.59|-1.62|0.2792
91498993|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.58||||0.7512|TWO_SIDED|95.0|-3.0|4.15|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.15|-3.00|0.7512
91498994|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.02||||0.649|TWO_SIDED|95.0|-3.39|5.43|||ANCOVA|||Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.43|-3.39|0.6490
91498995|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5||||0.5105|TWO_SIDED|95.0|-2.96|5.96|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.96|-2.96|0.5105
91498996|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.39||||0.8625|TWO_SIDED|95.0|-4.04|4.82|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|-4.04|0.8625
91498997|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.87||||0.1489|TWO_SIDED|95.0|-1.39|9.12|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.12|-1.39|0.1489
91498998|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.24||||0.0213|TWO_SIDED|95.0|0.93|11.54|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||11.54|0.93|0.0213
91498999|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.162|TWO_SIDED|95.0|-1.51|9.02|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.02|-1.51|0.1620
91705002|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.6|-4.5|
91705003|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
91499000|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.85||||0.2446|TWO_SIDED|95.0|-1.95|7.65|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.65|-1.95|0.2446
91499001|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.01||||0.0429|TWO_SIDED|95.0|0.16|9.85|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.85|0.16|0.0429
91499002|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.35||||0.1721|TWO_SIDED|95.0|-1.46|8.16|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.16|-1.46|0.1721
91499003|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.08||||0.0291|TWO_SIDED|95.0|0.42|7.74|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.74|0.42|0.0291
91705004|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|4.7|||||TWO_SIDED|95.0|-4.5|14.1||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||14.1|-4.5|
91499004|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.93||||0.0017|TWO_SIDED|95.0|2.23|9.62|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.62|2.23|0.0017
91499005|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.32||||0.0763|TWO_SIDED|95.0|-0.35|6.99|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.35|0.0763
91499006|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58||||0.1524|TWO_SIDED|95.0|-0.95|6.11|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.11|-0.95|0.1524
91705005|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-7.8|||||TWO_SIDED|95.0|-15.8|0.0||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||-0.0|-15.8|
91705006|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.9||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.9|-2.9|
91499007|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.36||||0.0032|TWO_SIDED|95.0|1.8|8.93|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.93|1.80|0.0032
91705007|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-1.9|||||TWO_SIDED|95.0|-6.6|2.4||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-6.6|
91705008|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.9|-6.3|
91705009|NCT01964716|183304652|SUPERIORITY_OR_OTHER||percent difference|-1.3|||||TWO_SIDED|95.0|-5.8|3.0||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.0|-5.8|
91705010|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.20|0.70|
91705011|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93||||||Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.93|0.69|
91705012|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.39||||||Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.39|0.89|
91705013|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.80|
91705014|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.06|0.70|
91705015|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.33|0.74|
91705016|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|1.0||||||Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.00|0.70|
91705017|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.79|1.27||||||Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.27|0.79|
91705018|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.08||||||Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.48|
91738760|NCT03423602|183369773|NON_INFERIORITY|Based on a Meta-Analysis of a focused systematic literature review from a comparable patient population, the estimated major vascular access site complication rate or PGsafety for the conservative Random Effect Model is 0.125 with a 95% Confidence Interval of 0.09 to 0.17. Given that the upper bound was 0.17 this justified the use of 0.13 as a valid PGsafety plus a non-inferiority margin of 0.04 yielding an overall non-inferiority limit (NLs) of 0.17 for Safety. Study power is greater than 90%|Wilson's exact test|0.0487|||<|0.0001|ONE_SIDED|95.0||0.0487|||Wilson's exact test|All 75 enrolled subjects, regardless of their enrolment status at 1-month post implantation, including all reported safety data where included.||"The test for non-inferiority for safety was based on a one-sided test (at the 0.025 significance level) for a binomial proportion with hypotheses:~H0s: Psafety ≥ NLs versus H1s: Psafety \< NLs Where: Psafety is the actual proportion of device related major vascular access site complications within the study population; and NLs is the non-inferiority limit for proportion of expected major vascular access site complications associated with cut-down and suture closure."||0.0487||<.0001
91738761|NCT03257358|183369778|OTHER|Estimation|least squares mean|-413.4|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-422.7||||ANCOVA|||||-404.|-422.7|
91738762|NCT03257358|183369778|OTHER|Estimation|least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.9|3.6|||ANCOVA|||||3.6|-3.9|
91738763|NCT03257358|183369779|OTHER|Estimation|least squares mean|-368.7|STANDARD_ERROR_OF_MEAN|7.08|||TWO_SIDED|95.0|-382.8|354.7|||ANCOVA|||||354.7|-382.8|
91738764|NCT03257358|183369779|OTHER|Estimation|least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-7.1|6.9|||ANCOVA|||||6.9|-7.1|
91738765|NCT03257358|183369780|OTHER|Estimation|least squares mean|-52.1|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-57.2|-46.9|||ANCOVA|||||-46.9|-57.2|
91738766|NCT03257358|183369780|OTHER|Estimation|least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-7.6|1.4|||ANCOVA|||||1.4|-7.6|
91738767|NCT03257358|183369781|OTHER|Estimation|least squares mean|-43.6|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-46.9|-40.3|||ANCOVA|||||-40.3|-46.9|
91738768|NCT03257358|183369781|OTHER|Estimation|least squares mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-3.0|1.7|||ANCOVA|||||1.7|-3.0|
91738769|NCT03257358|183369782|OTHER|Estimation|least squares mean|-36.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-37.2|-35.3|||ANCOVA|||||-35.3|-37.2|
91738770|NCT03257358|183369782|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||||1.2|-0.4|
91738771|NCT03257358|183369783|OTHER|Estimation|least squares mean|-53.2|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-55.1|-51.3|||ANCOVA|||||-51.3|-55.1|
91499008|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.82||||0.118|TWO_SIDED|95.0|-0.72|6.36|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.36|-0.72|0.1180
91499009|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.15||||0.1081|TWO_SIDED|95.0|-0.69|6.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.69|0.1081
91499010|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1||||0.0101|TWO_SIDED|95.0|1.22|8.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.99|1.22|0.0101
91705019|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.38|2.19||||||Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||2.19|1.38|
91705020|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.16||||||Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.16|0.74|
91705021|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.18||||||Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.71|
91705022|NCT01964716|183304653|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.67|1.25||||||Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.25|0.67|
91705023|NCT01370616|183304668|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% confidence interval for the estimated difference between the two groups has a lower bound greater than -15%, then ertapenem sodium will be considered at least as effective as piperacillin/tazobactam sodium.|Estimated Difference|-3.8|||||TWO_SIDED|95.0|-8.3|0.0|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||0.0|-8.3|
91705024|NCT01370616|183304669|SUPERIORITY_OR_OTHER||Estimated Difference|-1.7|||||TWO_SIDED|95.0|-5.5|1.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||1.8|-5.5|
91705025|NCT01370616|183304670|SUPERIORITY_OR_OTHER||Estimated Difference|-2.3|||||TWO_SIDED|95.0|-7.7|2.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||2.8|-7.7|
91705026|NCT01370616|183304671|SUPERIORITY_OR_OTHER||Estimated Difference|-4.1|||||TWO_SIDED|95.0|-11.9|3.4|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.4|-11.9|
91705027|NCT01370616|183304672|SUPERIORITY_OR_OTHER||Estimated Difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.3|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.3|-12.1|
91705028|NCT01370616|183304673|SUPERIORITY_OR_OTHER||Estimated Difference|7.3|||||TWO_SIDED|95.0|-0.9|15.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||15.4|-0.9|
91705029|NCT01370616|183304674|SUPERIORITY_OR_OTHER||Estimated Difference|-2.5|||||TWO_SIDED|95.0|-8.5|3.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||3.4|-8.5|
91705030|NCT01370616|183304675|SUPERIORITY_OR_OTHER||Estimated Difference|1.8|||||TWO_SIDED|95.0|-2.0|5.8|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||5.8|-2.0|
91705031|NCT01370616|183304676|SUPERIORITY_OR_OTHER||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-5.7|1.9|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||1.9|-5.7|
91705032|NCT00076999|183304688|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
91705033|NCT00076999|183304688|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.78
91705034|NCT00076999|183304689|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
91705035|NCT00076999|183304689|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705036|NCT00076999|183304690|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
91705037|NCT00076999|183304690|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705038|NCT00076999|183304691|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
91705039|NCT00076999|183304691|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705040|NCT00076999|183304692|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.01
91705041|NCT00076999|183304692|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705042|NCT00076999|183304693|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.06
91705043|NCT00076999|183304693|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705044|NCT00076999|183304694|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.60
91705045|NCT00076999|183304694|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91738772|NCT03257358|183369783|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||||1.4|-0.7|
91738773|NCT03257358|183369784|OTHER|Estimation|least squares mean|-140.4|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-145.8|-135.0|||ANCOVA|||||-135.0|-145.8|
91738774|NCT03257358|183369784|OTHER|Estimation|least squares mean|0.7|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-1.9|3.3|||ANCOVA|||||3.3|-1.9|
91738775|NCT03257358|183369785|OTHER|Estimation|least squares mean|-85.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-89.0|-81.4|||ANCOVA|||||-81.4|-89.0|
91738776|NCT03257358|183369785|OTHER|Estimation|least squares mean|0.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.3|1.9|||ANCOVA|||||1.9|-2.3|
91738777|NCT03257358|183369786|OTHER|Estimation|least squares mean|-27.9|STANDARD_ERROR_OF_MEAN|11.65|||TWO_SIDED|95.0|-51.1|-4.8|||ANCOVA|||||-4.8|-51.1|
91738778|NCT03257358|183369786|OTHER|Estimation|least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|3.47|||TWO_SIDED|95.0|-16.3|-2.6|||ANCOVA|||||-2.6|-16.3|
91738779|NCT03257358|183369787|OTHER|Estimation|least squares mean|-181.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-183.3|-179.0|||ANCOVA|||||-179.0|-183.3|
91738780|NCT03257358|183369787|OTHER|Estimation|least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-4.1|2.5|||ANCOVA|||||2.5|-4.1|
91738781|NCT03257358|183369788|OTHER|Estimation|least squares mean|-55.2|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-56.5|-53.9|||ANCOVA|||||-53.9|-56.5|
91499011|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.75||||0.7031|TWO_SIDED|95.0|-3.1|4.6|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.60|-3.10|0.7031
91738782|NCT03257358|183369788|OTHER|Estimation|least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||||1.1|-0.5|
91738783|NCT03257358|183369789|OTHER|Estimation|least squares mean|-7.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-8.0|-6.4|||ANCOVA|||||-6.4|-8.0|
91738784|NCT03257358|183369789|OTHER|Estimation|least squares mean|1.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|0.3|2.0|||ANCOVA|||||2.0|0.3|
91738785|NCT03257358|183369790|OTHER|Estimation|least squares mean|69.4|STANDARD_ERROR_OF_MEAN|13.78|||TWO_SIDED|95.0|42.1|96.7|||ANCOVA|||||96.7|42.1|
91738786|NCT03257358|183369790|OTHER|Estimation|least squares mean|117.0|STANDARD_ERROR_OF_MEAN|10.07|||TWO_SIDED|95.0|97.1|136.9|||ANCOVA|||||136.9|97.1|
91738787|NCT03257358|183369791|OTHER|Estimation|least squares mean|-782.6|STANDARD_ERROR_OF_MEAN|138.9|||TWO_SIDED|95.0|-1058.2|-507.1|||ANCOVA|||||-507.1|-1058.2|
91738788|NCT03257358|183369791|OTHER|Estimation|least squares mean|-485.9|STANDARD_ERROR_OF_MEAN|91.88|||TWO_SIDED|95.0|-667.3|-304.4|||ANCOVA|||||-304.4|-667.3|
91738789|NCT03257358|183369792|OTHER|Estimation|least squares mean|-33.3|STANDARD_ERROR_OF_MEAN|7.47|||TWO_SIDED|95.0|-48.2|-18.5|||ANCOVA|||||-18.5|-48.2|
91738790|NCT03257358|183369792|OTHER|Estimation|least squares mean|-25.8|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-36.7|-14.9|||ANCOVA|||||-14.9|-36.7|
91738791|NCT03257358|183369793|OTHER|Estimation|least squares mean|-888.7|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|95.0|-914.6|-862.7|||ANCOVA|||||-862.7|-914.6|
91738792|NCT03257358|183369793|OTHER|Estimation|least squares mean|-3.3|STANDARD_ERROR_OF_MEAN|7.24|||TWO_SIDED|95.0|-17.6|11.0|||ANCOVA|||||11.0|-17.6|
91738793|NCT03257358|183369794|OTHER|Estimation|least squares mean|-39.5|STANDARD_ERROR_OF_MEAN|1.053|||TWO_SIDED|95.0|-41.59|-37.42|||ANCOVA|||||-37.42|-41.59|
91738794|NCT03257358|183369794|OTHER|Estimation|least squares mean|0.14|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.87|1.14|||ANCOVA|||||1.14|-0.87|
91738795|NCT03257358|183369795|OTHER|Estimation|least squares mean|-248.9|STANDARD_ERROR_OF_MEAN|15.0|||TWO_SIDED|95.0|-278.7|-219.2|||ANCOVA|||||-219.2|-278.7|
91738796|NCT03257358|183369795|OTHER|Estimation|least squares mean|-9.9|STANDARD_ERROR_OF_MEAN|7.71|||TWO_SIDED|95.0|-25.1|5.4|||ANCOVA|||||5.4|-25.1|
91738797|NCT03257358|183369796|OTHER|Estimation|least squares mean|5.6|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|3.13|8.08|||ANCOVA|||||8.08|3.13|
91738798|NCT03257358|183369796|OTHER|Estimation|least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.364|||TWO_SIDED|95.0|-0.68|0.76|||ANCOVA|||||0.76|-0.68|
91738799|NCT03257358|183369797|OTHER|Estimation|least squares mean|-231.0|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|-234.5|-227.6|||ANCOVA|||||-227.6|-234.5|
91738800|NCT03257358|183369797|OTHER|Estimation|least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-5.2|4.5|||ANCOVA|||||4.5|-5.2|
91738801|NCT03257358|183369798|OTHER|Estimation|least squares mean|-8.3|STANDARD_ERROR_OF_MEAN|0.455|||TWO_SIDED|95.0|-9.21|-7.4|||ANCOVA|||||-7.40|-9.21|
91738802|NCT03257358|183369798|OTHER|Estimation|least squares mean|0.32|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|-0.17|0.82|||ANCOVA|||||0.82|-0.17|
91738803|NCT02852967|183369830|SUPERIORITY|||||||0.6384|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 23) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6384
91499012|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.27||||0.4253|TWO_SIDED|95.0|-1.86|4.39|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.39|-1.86|0.4253
91499013|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.091|TWO_SIDED|95.0|-0.44|5.89|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.89|-0.44|0.0910
91499014|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.82||||0.2526|TWO_SIDED|95.0|-1.3|4.95|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.95|-1.30|0.2526
91499015|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62||||0.0195|TWO_SIDED|95.0|0.42|4.82|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|0.42|0.0195
91499016|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.66||||0.0013|TWO_SIDED|95.0|1.44|5.88|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.88|1.44|0.0013
91499017|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.14||||0.0568|TWO_SIDED|95.0|-0.06|4.34|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.34|-0.06|0.0568
91499018|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.8529|TWO_SIDED|95.0|-1.54|1.27|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.27|-1.54|0.8529
91499019|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54||||0.4564|TWO_SIDED|95.0|-0.88|1.96|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.96|-0.88|0.4564
91499020|NCT00333866|182867860|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13||||0.8576|TWO_SIDED|95.0|-1.28|1.54|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.54|-1.28|0.8576
91499021|NCT00333866|182867861|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29||||0.7384|TWO_SIDED|95.0|-1.98|1.4|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.40|-1.98|0.7384
91499022|NCT00333866|182867861|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.41||||0.1044|TWO_SIDED|95.0|-3.12|0.29|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-3.12|0.1044
91531047|NCT00932646|182938400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.055||0.0076||95.0|0.04|0.256|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.256|0.040|0.0076
91705046|NCT00076999|183304695|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.20
91705047|NCT00076999|183304695|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705048|NCT00076999|183304696|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.18
91705049|NCT00076999|183304696|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
91705050|NCT00076999|183304698|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
91705051|NCT00076999|183304698|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.47
91705052|NCT00076999|183304699|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
91705053|NCT00076999|183304699|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.81
91705054|NCT00076999|183304700|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
91705055|NCT00076999|183304700|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.69
91705056|NCT00076999|183304702|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.64
91705057|NCT00076999|183304702|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.26
91705058|NCT00076999|183304703|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.25
91705059|NCT00076999|183304703|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.70
91705060|NCT00076999|183304704|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.73
91705061|NCT00076999|183304704|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.79
91705062|NCT00076999|183304706|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.38
91705063|NCT00076999|183304706|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.20
91705064|NCT00076999|183304707|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.08
91705065|NCT00076999|183304707|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.36
91705066|NCT00076999|183304708|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.23
91499023|NCT00333866|182867861|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87||||0.3137|TWO_SIDED|95.0|-2.58|0.83|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.83|-2.58|0.3137
91499024|NCT00333866|182867862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.09|TWO_SIDED|95.0|-1.28|0.09|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.09|-1.28|0.0900
91499025|NCT00333866|182867862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5||||0.1564|TWO_SIDED|95.0|-1.2|0.19|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-1.20|0.1564
91499026|NCT00333866|182867862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7519|TWO_SIDED|95.0|-0.8|0.58|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.58|-0.80|0.7519
91499027|NCT00333866|182867862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15||||0.6416|TWO_SIDED|95.0|-0.5|0.8|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.80|-0.50|0.6416
91499028|NCT00333866|182867862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0778|TWO_SIDED|95.0|-1.25|0.07|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.07|-1.25|0.0778
91499029|NCT00333866|182867862|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.5191|TWO_SIDED|95.0|-0.87|0.44|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.87|0.5191
91499030|NCT00333866|182867863|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.534|TWO_SIDED|95.0|-5.97|3.09|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.09|-5.97|0.5340
91499031|NCT00333866|182867863|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.44||||0.0014|TWO_SIDED|95.0|-12.0|-2.88|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.88|-12.00|0.0014
91705067|NCT00076999|183304708|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.23
91531048|NCT00932646|182938401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.082|0.154|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.154|0.082|<0.0001
91531049|NCT00932646|182938401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.084|0.157|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.157|0.084|<0.0001
91531050|NCT00932646|182938401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.119|<0.0001
91705068|NCT05821296|183304715|OTHER|Change of sum of total lesions at the end of the study from baseline/Day 0 to evaluate the efficacy and clinical performance of Crystal Peel for the treatment of acne.|Mean Difference (Final Values)|-14.58|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-17.31|-11.84|||ANCOVA|||||-11.84|-17.31|<0.0001
91705069|NCT05821296|183304716|OTHER||Mean Difference (Final Values)|1.85|STANDARD_DEVIATION|0.87|||TWO_SIDED|95.0|1.54|2.16||||||||2.16|1.54|
91499032|NCT00333866|182867863|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56||||0.2694|TWO_SIDED|95.0|-7.09|1.98|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.98|-7.09|0.2694
91499033|NCT00333866|182867864|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|263.77||||0.1277|TWO_SIDED|95.0|-75.78|603.33|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.||603.33|-75.78|0.1277
91499034|NCT00333866|182867864|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|47.89||||0.7829|TWO_SIDED|95.0|-293.2|389.02|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||389.02|-293.2|0.7829
91499035|NCT00333866|182867864|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.51||||0.9471|TWO_SIDED|95.0|-351.9|328.86|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||328.86|-351.9|0.9471
91499036|NCT06073119|182867865|SUPERIORITY||Response rate difference (RRD), %|23.43||||0.0874|TWO_SIDED|95.0|-2.74|45.98||A hierarchical testing was used to control the overall type I error of 0.05 (two-sided). Testing was performed in the order of 200 mg BID, 100 mg BID, 200 mg QD versus placebo.|Cochran-Mantel-Haenszel|Adjusted for baseline PASI score (\<=20, \>20).|Difference = SAR441566 Dose Regimen 200 mg BID - placebo.|||45.98|-2.74|0.0874
91499037|NCT06073119|182867865|SUPERIORITY||RRD, %|33.08||||0.0185|TWO_SIDED|95.0|5.71|54.83||A hierarchical testing was used to control the overall type I error of 0.05 (two-sided). Testing was performed in the order of 200 mg BID, 100 mg BID, 200 mg QD versus placebo.|Cochran-Mantel-Haenszel|Adjusted for baseline PASI score (\<=20, \>20).|Difference = SAR441566 Dose Regimen 100 mg BID - placebo.|||54.83|5.71|0.0185
91499038|NCT06073119|182867865|SUPERIORITY||RRD, %|38.02||||0.0077|TWO_SIDED|95.0|10.62|58.84||A hierarchical testing was used to control the overall type I error of 0.05 (two-sided). Testing was performed in the order of 200 mg BID, 100 mg BID, 200 mg QD versus placebo.|Cochran-Mantel-Haenszel|Adjusted for baseline PASI score (\<=20, \>20).|Difference = SAR441566 Dose Regimen 200 mg QD - placebo.|||58.84|10.62|0.0077
91499039|NCT06073119|182867865|SUPERIORITY||RRD, %|9.35||||0.4576|TWO_SIDED|95.0|-14.72|32.4||No multiplicity adjustment, hence p-value is nominal.|Cochran-Mantel-Haenszel|Adjusted for baseline PASI score (\<=20, \>20).|Difference = SAR441566 Dose Regimen 100 mg QD - placebo.|||32.40|-14.72|0.4576
91499040|NCT06073119|182867865|SUPERIORITY||RRD, %|13.44||||0.3051|TWO_SIDED|95.0|-11.38|36.72||No multiplicity adjustment, hence p-value is nominal.|Cochran-Mantel-Haenszel|Adjusted for baseline PASI score (\<=20, \>20).|Difference = SAR441566 Dose Regimen 50 mg QD - placebo.|||36.72|-11.38|0.3051
91499041|NCT00456547|182867880|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Adjusted for 12 comparisons|t-test, 2 sided|||||||<0.05
91705070|NCT05821296|183304717|OTHER||Mean Difference (Final Values)|1.82|STANDARD_DEVIATION|1.07|||TWO_SIDED|95.0|1.44|2.2||||||||2.20|1.44|
91705071|NCT05821296|183304718|OTHER||Mean value in local tolerance score|2.21|STANDARD_DEVIATION|0.65|||TWO_SIDED|95.0|1.98|2.44||||||||2.44|1.98|
91705072|NCT05821296|183304719|OTHER|Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.|% of patients with positive answers|79.0|||||TWO_SIDED|95.0|61.0|89.0||||||||89|61|
91705073|NCT05821296|183304719|OTHER||% of patients with positive answers|94.0|||||TWO_SIDED|95.0|80.0|98.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||98|80|
91705074|NCT05821296|183304719|OTHER||% of patients with positive answers|88.0|||||TWO_SIDED|95.0|73.0|95.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||95|73|
91705075|NCT05821296|183304719|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|68.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|68|
91705076|NCT05821296|183304719|OTHER||% of patients with positive answers|91.0|||||TWO_SIDED|95.0|77.0|97.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||97|77|
91705077|NCT05821296|183304719|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|69.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|69|
91705078|NCT05821296|183304719|OTHER||% of patients with positive answers|78.0|||||TWO_SIDED|95.0|61.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|61|
91705079|NCT05821296|183304719|OTHER||% of patients with positive answers|79.0|||||TWO_SIDED|95.0|62.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|62|
91705080|NCT05821296|183304719|OTHER||% of patients with positive answers|76.0|||||TWO_SIDED|95.0|59.0|87.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||87|59|
91705081|NCT05821296|183304721|OTHER||Mean Difference (Net)|-47.24|STANDARD_DEVIATION|56.61|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
91705082|NCT05821296|183304721|OTHER||Mean Difference (Final Values)|-30.85|STANDARD_DEVIATION|63.92||0.01|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.010
91705083|NCT05821296|183304721|OTHER||Mean Difference (Final Values)|-41.69|STANDARD_DEVIATION|73.69|<|0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||<0.004
91705084|NCT05821296|183304721|OTHER||Mean Difference (Final Values)|-29.13|STANDARD_DEVIATION|61.45||0.013|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.013
91705085|NCT05821296|183304722|OTHER||Mean Difference (Final Values)|-2832.39|STANDARD_DEVIATION|3217.15|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
91705086|NCT05821296|183304722|OTHER||Mean Difference (Final Values)|-1754.88|STANDARD_DEVIATION|4220.25||0.025|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.025
91499042|NCT00456547|182867881|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons.|t-test, 2 sided|||||||<0.05
91499043|NCT00456547|182867882|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|t-test, 2 sided|||||||<0.05
91499044|NCT00456547|182867883|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|Wilcoxon (Mann-Whitney)|||||||<0.05
91499045|NCT02408315|182867892|NON_INFERIORITY|Estimates obtained from Kaplan-Meier method and results of Log-rank test. P-value for non-inferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs. HA: HR \> .74), p-value \< .05 provides evidence to reject inferiority and conclude BM is non-inferior to VM.||||||0.663|||||||Cox proportional|||||||0.663
91499046|NCT01285310|182867921|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.4||||0.3134|TWO_SIDED|95.0|-27.1|7.0|||Chi-squared||2-sided 95% CI of the proportion difference is based on a normal approximation to the binomial distribution|Significance testing was done using the following closed procedure; if the overall test among treatments is statistically significant at the 0.05 level, pair-wise comparisons (30 mg versus PBO, and 20 mg versus PBO, using a 0.05 two-sided significance level) will be performed||7.0|-27.1|0.3134
91499047|NCT01285310|182867921|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.2||||0.8721|TWO_SIDED|95.0|-16.2|13.8|||Chi-squared||2-sided 95% CI is based on a normal approximation to the binomial distribution|||13.8|-16.2|0.8721
91705087|NCT05821296|183304722|OTHER||Mean Difference (Final Values)|-2763.41|STANDARD_DEVIATION|4965.84||0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.004
91705088|NCT05821296|183304722|OTHER||Mean Difference (Final Values)|-1742.41|STANDARD_DEVIATION|3974.21||0.021|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.021
91705089|NCT05821296|183304723|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.3|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
91705090|NCT05821296|183304723|OTHER||Mean Difference (Final Values)|-0.68|STANDARD_DEVIATION|1.68||0.029|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.029
91705091|NCT05821296|183304723|OTHER||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|2.01||0.006|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.006
91705092|NCT05821296|183304723|OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|1.67||0.037|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.037
91705093|NCT05821296|183304724|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_DEVIATION|0.58||0.001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.001
91705094|NCT05821296|183304724|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|0.71||0.348|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.348
91705095|NCT05821296|183304724|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_DEVIATION|0.75||0.091|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.091
91499048|NCT01285310|182867922|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.004|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499049|NCT01285310|182867922|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.091|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91705096|NCT05821296|183304724|OTHER||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.65||0.19|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.190
91499050|NCT01285310|182867923|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.5||||||||||||||||||
91499051|NCT01285310|182867923|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.6||||||||||||||||||
91705097|NCT05821296|183304725|OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|3.55||0.011|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.011
91705098|NCT05821296|183304725|OTHER||Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|3.28||0.281|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.281
91705099|NCT05821296|183304725|OTHER||Mean Difference (Final Values)|-1.57|STANDARD_DEVIATION|4.46||0.06|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.060
91738804|NCT02852967|183369830|SUPERIORITY|||||||0.6419|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID + placebo (n = 22) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6419
91499052|NCT01285310|182867924|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.007||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
91499053|NCT01285310|182867924|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, treatment group as a factor and the baseline value as a covariate.|||||
91499054|NCT01285310|182867925|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate|||||
91499055|NCT01285310|182867925|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.|||||
91738805|NCT02852967|183369830|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 400 mg QD + placebo (n = 21) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||> 0.9999
91738806|NCT02852967|183369830|SUPERIORITY|||||||0.3859|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg (n = 26) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.3859
91738807|NCT02852967|183369830|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil (n = 92) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75||||0.4435
91738808|NCT02852967|183369830|SUPERIORITY|||||||0.2721|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 14) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.2721
91738809|NCT02852967|183369830|SUPERIORITY|||||||0.3577|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID+ Placebo (n = 15) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3577
91738810|NCT02852967|183369830|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 500 mg QD + Placebo (n = 17) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||> 0.9999
91738811|NCT02852967|183369830|SUPERIORITY|||||||0.3402|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg/day (n = 16) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3402
91738812|NCT02852967|183369830|SUPERIORITY|||||||0.3542|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil 200 mg QD + Placebo (n = 62) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3542
91738813|NCT02852967|183369834|SUPERIORITY|||||||0.5728|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5728
91738814|NCT02852967|183369834|SUPERIORITY|||||||0.1962|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.1962
91738815|NCT02852967|183369834|SUPERIORITY|Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear|||||>|0.9999|||||||Fisher Exact|||||||> 0.9999
91738816|NCT02852967|183369834|SUPERIORITY|||||||0.5583|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5583
91738817|NCT02852967|183369834|SUPERIORITY|||||||0.2538|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.2538
91738818|NCT00339040|183369843|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
91499056|NCT01285310|182867926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.21||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.||||||
91499057|NCT01285310|182867926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
91499058|NCT01285310|182867927|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.5||||||||||||||||||
91499059|NCT01285310|182867927|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.2||||||||||||||||||
91499060|NCT01285310|182867928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, treatment group as a factor and the baseline value as a covariate.||||||
91738819|NCT00887159|183369862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.45|TWO_SIDED|95.0|0.65|1.47||P-value is one-sided.|Regression, Cox||The hazard ratio was derived comparing Arm B to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.47|0.65|0.45
91705100|NCT05821296|183304725|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|3.8||0.209|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.209
91705101|NCT05821296|183304726|OTHER||Mean Difference (Final Values)|-26495.83|STANDARD_DEVIATION|33223.6|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
91705102|NCT05821296|183304726|OTHER||Mean Difference (Final Values)|-14447.02|STANDARD_DEVIATION|44054.48||0.073|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.073
91738820|NCT00887159|183369862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.48|TWO_SIDED|95.0|0.66|1.48||P-value is one-sided.|Regression, Cox||Hazard ratio was derived comparing Arm C to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.48|0.66|0.48
91738821|NCT00887159|183369865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.69||||0.01|TWO_SIDED|95.0|1.13|2.52|||Regression, Cox||Hazard ratio was derived comparing the high CTCs group to the low CTCs group.|||2.52|1.13|0.01
91499061|NCT01285310|182867928|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|||||TWO_SIDED|||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
91499062|NCT01285310|182867929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.15|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
91499063|NCT01285310|182867929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
91499064|NCT01285310|182867930|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.58|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91705103|NCT05821296|183304726|OTHER|If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Mean Difference (Final Values)|-25315.34|STANDARD_DEVIATION|49884.67||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.008
91499065|NCT01285310|182867930|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.26||||||||||||||||||
91499066|NCT01285310|182867931|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-35.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499067|NCT01285310|182867931|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-38.37|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499068|NCT01285310|182867932|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.35|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499069|NCT01285310|182867932|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499070|NCT01285310|182867933|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.59|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499071|NCT01285310|182867933|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.84|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91705104|NCT05821296|183304726|OTHER||Mean Difference (Final Values)|-13287.34|STANDARD_DEVIATION|39615.92||0.071|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.071
91705105|NCT05821296|183304727|OTHER||Mean Difference (Final Values)|-7518.25|STANDARD_DEVIATION|13340.45||0.003|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
91738822|NCT01109108|183369876|OTHER||Risk Ratio (RR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91499072|NCT01285310|182867934|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.93|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91738823|NCT03420742|183369889|OTHER||Geometric least squares mean ratio|0.741|||||TWO_SIDED|90.0|0.6|0.915|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||0.915|0.600|
91738824|NCT03420742|183369890|OTHER||Geometric least squares mean ratio|0.836|||||TWO_SIDED|90.0|0.662|1.06|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||1.06|0.662|
91738825|NCT00570323|183369933|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
91738826|NCT03856359|183369937|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
91738827|NCT03856359|183369939|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91499073|NCT01285310|182867934|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
91499074|NCT01285310|182867935|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499075|NCT01285310|182867935|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|58.05||||||||||||||||||
91738828|NCT03856359|183369941|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
91738829|NCT03856359|183369943|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91738830|NCT03856359|183369944|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
91738831|NCT03856359|183369945|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91738832|NCT03856359|183369946|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91738833|NCT03856359|183369947|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
91738834|NCT03856359|183369948|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91738835|NCT03856359|183369949|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
91738836|NCT03856359|183369950|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
91499076|NCT01285310|182867936|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|7.18|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499077|NCT01285310|182867936|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-16.19|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499078|NCT01285310|182867937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
91499079|NCT01285310|182867937|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.1|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
91738837|NCT03856359|183369951|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
91738838|NCT03856359|183369952|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
91738839|NCT03856359|183369953|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
91738840|NCT03856359|183369954|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91738841|NCT03856359|183369955|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91738842|NCT02266147|183369958|OTHER|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.||||||||||||||||MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|||
91738843|NCT02347605|183369964|SUPERIORITY|||||||0.25||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.25
91738844|NCT02347605|183369965|SUPERIORITY|||||||0.18||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.18
91738845|NCT03937479|183369980|SUPERIORITY||LS mean difference|0.1242|STANDARD_ERROR_OF_MEAN|0.03691||0.0008|TWO_SIDED|95.0|0.0517|0.1968||The mixed model for repeated measures (MMRM) model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1968|0.0517|0.0008
91738846|NCT03937479|183369980|SUPERIORITY||LS mean difference|0.1072|STANDARD_ERROR_OF_MEAN|0.03703||0.004|TWO_SIDED|95.0|0.0344|0.18||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1800|0.0344|0.0040
91738847|NCT03937479|183369980|SUPERIORITY||LS mean difference|0.0912|STANDARD_ERROR_OF_MEAN|0.03723||0.0148|TWO_SIDED|95.0|0.018|0.1643||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1643|0.0180|0.0148
91738848|NCT03937479|183369980|SUPERIORITY||LS mean difference|0.0775|STANDARD_ERROR_OF_MEAN|0.03697||0.0368|TWO_SIDED|95.0|0.0048|0.1501||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1501|0.0048|0.0368
91705106|NCT05821296|183304727|OTHER||Mean Difference (Final Values)|-7230.81|STANDARD_DEVIATION|17547.6||0.041|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.041
91705107|NCT05821296|183304727|OTHER||Mean Difference (Final Values)|-9086.26|STANDARD_DEVIATION|18306.64||0.007|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
91705108|NCT05821296|183304727|OTHER||Mean Difference (Final Values)|64.71|STANDARD_DEVIATION|14542.17||0.931|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.931
91705109|NCT05821296|183304728|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.66||0.005|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.005
91705110|NCT05821296|183304728|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.8||0.035|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.035
91705111|NCT05821296|183304728|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_DEVIATION|0.86||0.036|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.036
91738849|NCT00532844|183370039|SUPERIORITY||Geometric Mean Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.2|1.8||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH4 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH4 concentrations when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH4 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.8|1.2|<0.001
91499080|NCT01285310|182867938|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
91499081|NCT01285310|182867938|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||||||||||||||||
91738850|NCT00532844|183370040|SUPERIORITY||Geometric Mean Ratio|0.9||||0.139|TWO_SIDED|95.0|0.7|1.0||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH2 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH2 when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH2 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.0|0.7|0.139
91760073|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.29|0.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.29|
91499082|NCT01285310|182867939|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
91499083|NCT01285310|182867939|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9||||||||||||||||||
91499084|NCT01285310|182867940|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.4||||||||||||||||||
91499085|NCT01285310|182867940|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.1||||||||||||||||||
91499086|NCT01285310|182867941|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.5||||||||||||||||||
91499087|NCT01285310|182867941|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||||||||||||||||
91499088|NCT01285310|182867942|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.3||||||||||||||||||
91499089|NCT01285310|182867942|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.5||||||||||||||||||
91499090|NCT01285310|182867943|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.5||||||||||||||||||
91499091|NCT01285310|182867943|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||||||||||||||||
91499092|NCT01285310|182867944|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||||||
91705112|NCT05821296|183304728|OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.77||0.784|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.784
91705113|NCT05821296|183304729|OTHER||Mean Difference (Final Values)|-2249.72|STANDARD_DEVIATION|4466.14||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.||Comparison of change from baseline of conspicuous length of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.011
91705114|NCT05821296|183304729|OTHER||Mean Difference (Final Values)|-2315.0|STANDARD_DEVIATION|6197.86||0.074|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.074
91499093|NCT01285310|182867944|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.5|||||TWO_SIDED|||||||||||||
91499094|NCT01285310|182867945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
91738851|NCT00532844|183370040|SUPERIORITY||Geometric Mean Ratio|0.96||||0.57|TWO_SIDED|95.0|0.83|1.11||The model will constitute independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable Total B concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in Total B (biopterin) when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the Total B (biopterin) concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.11|0.83|0.570
91738852|NCT00532844|183370043|SUPERIORITY|||||||0.593|||||||ANCOVA|The model will have the treatments and the baseline measurement as independent variables and measurement at Day 13 as the dependent variable.||The raw value of PAT obtained from the first period (baseline to Day 13) will be used to compare the two treatments.||||0.593
91738853|NCT00251693|183370061|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.33||||0.004||95.0|2.17|10.48||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.48|2.17|0.004
91738854|NCT00251693|183370061|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.84||||0.001||95.0|2.7|10.98||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.98|2.70|0.001
91738855|NCT00251693|183370061|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.727
91738856|NCT00251693|183370062|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.002
91738857|NCT00251693|183370062|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.045
91738858|NCT00251693|183370062|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.245
91738859|NCT00251693|183370063|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.011
91738860|NCT00251693|183370063|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.017
91738861|NCT00251693|183370063|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.927
91738862|NCT00251693|183370064|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.2||||0.06||95.0|2.3|10.11||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.11|2.30|0.060
91738863|NCT00251693|183370064|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.08||||0.029||95.0|2.16|10.0||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.00|2.16|0.029
91499095|NCT01285310|182867945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.98|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
91499096|NCT01285310|182867946|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
91499097|NCT01285310|182867946|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.24||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
91738864|NCT00251693|183370064|SUPERIORITY_OR_OTHER|||||||0.707||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.707
91738865|NCT00251693|183370065|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.705
91499098|NCT01285310|182867947|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-4.3||||||||||||||||||
91499099|NCT01285310|182867947|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.6||||||||||||||||||
91499100|NCT01285310|182867948|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
91499101|NCT01285310|182867948|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
91499102|NCT01285310|182867949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499103|NCT01285310|182867949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.01|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.|||||
91705115|NCT05821296|183304729|OTHER||Mean Difference (Final Values)|-2700.55|STANDARD_DEVIATION|5962.3||0.007|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
91705116|NCT05821296|183304729|OTHER||Mean Difference (Final Values)|430.65|STANDARD_DEVIATION|5021.2||0.779|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
91705117|NCT05821296|183304730|OTHER||Mean Difference (Final Values)|-75800.75|STANDARD_DEVIATION|142643.92||0.003|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
91705118|NCT05821296|183304730|OTHER||Mean Difference (Final Values)|-73517.86|STANDARD_DEVIATION|197224.85||0.054|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.054
91705119|NCT05821296|183304730|OTHER||Mean Difference (Final Values)|-90424.89|STANDARD_DEVIATION|198264.2||0.008|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.008
91705120|NCT05821296|183304730|OTHER||Mean Difference (Final Values)|1314.03||||0.779|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
91499104|NCT01285310|182867950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
91499105|NCT01285310|182867950|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-7.02|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
91705121|NCT01217385|183304731|EQUIVALENCE|under the NULL, it is assume that there is no difference between a 40% decrease in TOI, and a less than 40% decrease or an increase in TOI in their ability to predict pCR+|Odds Ratio (OR)|4.667||||0.059|TWO_SIDED|95.0|0.95|23.04||5% alpha threshold for significance.|Regression, Logistic|||"This analysis will look at the ability of the % change in DOSI measured tumor Optical Index (TOI) from baseline to mid-therapy to predict pathologic response using logistic regression.~Pathologic response (dichotomized into responders and non-responders) will be used as the reference standard and %change in TOI ratio (dichotomized at -40%) will be used to estimate pCR (+/-)= alpha + beta1(%change TOI)"||23.04|0.95|0.059
91738866|NCT00251693|183370065|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.146
91738867|NCT00251693|183370065|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.283
91738868|NCT00251693|183370066|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.896
91499106|NCT01285310|182867951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
91499107|NCT01285310|182867951|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-37.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
91499108|NCT01285310|182867952|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499109|NCT01285310|182867952|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-12.5|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499110|NCT01285310|182867953|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.85|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499111|NCT01285310|182867953|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.8|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499112|NCT01285310|182867954|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.57|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499113|NCT01285310|182867954|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.72|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499114|NCT01285310|182867955|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|8.29|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499115|NCT01285310|182867955|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|67.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91738869|NCT00251693|183370066|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.241
91738870|NCT00251693|183370066|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.211
91738871|NCT04005586|183370067|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group had a mean MRCYL of -0.14 (+/- 0.21D) compared to -0.33 (+/- 0.29D) and -0.40 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066 respectively.|||
91738872|NCT04005586|183370068|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group MRCYL change from baseline was 0.36 (+/- 0.21D) compared to 0.17 (+/- 0.29D) and 0.10 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066, respectively.|||
91738873|NCT02031302|183370082|OTHER|One-sided Clopper-Pearson 98.699% upper bound|||||<|0.0001||||||The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.|Chi-squared|||Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.|One-sided Clopper-Pearson 98.699% upper bound: 4.11% Performance goal is 14%|||<.0001
91738874|NCT01847443|183370090|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.107|||||TWO_SIDED|90.0|1.07|1.147|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.147|1.070|
91738875|NCT01847443|183370095|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.098|||||TWO_SIDED|90.0|1.061|1.137|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.137|1.061|
91738876|NCT01847443|183370096|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.044|||||TWO_SIDED|90.0|1.002|1.089|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.089|1.002|
91738877|NCT01847443|183370097|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.071|||||TWO_SIDED|90.0|1.028|1.116|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.116|1.028|
91738878|NCT04067492|183370098|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|28.63||||0.1331|TWO_SIDED|95.0|4.21|53.05||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||53.05|4.21|0.1331
91499116|NCT01285310|182867956|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|12.05|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499117|NCT01285310|182867956|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
91499118|NCT01285310|182867957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
91499119|NCT01285310|182867957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
91499120|NCT01285310|182867958|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.4||||||||||||||||||
91499121|NCT01285310|182867958|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.6||||||||||||||||||
91499122|NCT01285310|182867959|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.9||||||||||||||||||
91499123|NCT01285310|182867959|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.3||||||||||||||||||
91499124|NCT01285310|182867960|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.2||||||||||||||||||
91499125|NCT01285310|182867960|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.0||||||||||||||||||
91499126|NCT00514540|182867994|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|ONE_SIDED|95.0||||"Stoppage of trial early if 1) probability of response with the frontline treatment DC in the 1st 2 courses is unacceptably low compared to a target of 30% Pr(p1\*p2 \> .30\|data) \< 0.005, or 2) risk of a SAE is unacceptably high Pr(m \> m\* \|data) \< 0.001"|Bayesian probability model|Operating Characteristics of futility monitoring rule 1 \& safety monitoring rule 2 applied simultaneously for frontline treatment DC in courses 1 \& 2.||Disease status evaluated at the end of course 1 \& the end of course 2. Primary outcomes are response, defined as the absence of disease progression, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death. Bayesian probability model \& decision rules used to monitor patient outcomes.||||< 0.005
91760074|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.35|0.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.35|
91499127|NCT00555321|182867999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.9|||||TWO_SIDED|95.0|16.1|49.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||49.8|16.1|
91760075|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.65|
91760076|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|0.06|0.91||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.91|0.06|
91760077|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.24|0.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-0.24|
91760078|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.46|0.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.46|
91760079|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.48|0.37||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.37|-0.48|
91760080|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|||||TWO_SIDED|95.0|0.15|1.06||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.06|0.15|
91760081|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.28|0.63||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.63|-0.28|
91760082|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.49|0.42||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.49|
91499128|NCT00555321|182867999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.6|||||TWO_SIDED|95.0|9.6|43.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||43.5|9.6|
91499129|NCT00555321|182867999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|||||TWO_SIDED|95.0|14.8|48.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||48.5|14.8|
91499130|NCT00555321|182867999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-8.7|29.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||29.6|-8.7|
91499131|NCT00555321|182867999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-15.3|23.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||23.2|-15.3|
91499132|NCT00555321|182867999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-9.8|28.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||28.4|-9.8|
91499133|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.7|-12.9|
91499134|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-13.6|8.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.5|-13.6|
91499135|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||||TWO_SIDED|95.0|-23.8|1.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||1.5|-23.8|
91499136|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||||
91531051|NCT00653263|182938403|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.||||<0.05
91531052|NCT00653263|182938404|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
91499137|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-12.1|11.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||11.3|-12.1|
91499138|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-22.9|4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.1|-22.9|
91499139|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-12.9|
91499140|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||||TWO_SIDED|95.0|-18.1|5.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.4|-18.1|
91499141|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.1|||||TWO_SIDED|95.0|-38.9|-9.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-9.5|-38.9|
91499142|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-9.9|14.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||14.4|-9.9|
91499143|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-15.5|10.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||10.7|-15.5|
91738879|NCT04067492|183370098|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|-2.05||||0.1331|TWO_SIDED|95.0|-30.6|26.5||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||26.50|-30.60|0.1331
91738880|NCT04067492|183370098|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|16.7||||0.1331|TWO_SIDED|95.0|-12.67|46.08||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||46.08|-12.67|0.1331
91738881|NCT04067492|183370098|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|3.12||||0.1331|TWO_SIDED|95.0|-25.1|31.33||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\]|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||31.33|-25.10|0.1331
91738882|NCT04067492|183370098|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|5.96||||0.1331|TWO_SIDED|95.0|-24.22|36.14||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||36.14|-24.22|0.1331
91738883|NCT04067492|183370105|OTHER|||||||0.5995|||||||Log Rank|||||||0.5995
91738884|NCT04067492|183370105|OTHER|||||||0.9012|||||||Log Rank|||||||0.9012
91738885|NCT04067492|183370107|OTHER||difference in proportions|63.5||||0.0066|TWO_SIDED|95.0|19.9|88.6|||Fisher Exact|||||88.6|19.9|0.0066
91738886|NCT04067492|183370107|OTHER||difference in proportions|-5.6|||>|0.9999|TWO_SIDED|95.0|-50.1|45.5|||Fisher Exact|||||45.5|-50.1|>0.9999
91738887|NCT04067492|183370107|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
91738888|NCT04067492|183370107|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
91738889|NCT04067492|183370107|OTHER||difference in proportions|17.8||||0.5804|TWO_SIDED|95.0|-33.7|67.8|||Fisher Exact|||||67.8|-33.7|0.5804
91738890|NCT00956384|183370131|SUPERIORITY|A minimally clinically important difference of 4 as statistically significant at the 0.05 level (two-sided), with a power equal to 0.85.|Mean Difference (Final Values)|-2.69||||0.05|TWO_SIDED|95.0|-10.57|5.19||Threshold for statistical significance was p= 0.05|t-test, 2 sided|||For the comparison of mean BREAST-Q subdomain score at each timepoint, Mann-Whitney U test was used for skewed data, while independent t-test was used for not skewed data. We investigated the possibly variable effects of the treatment group differences across multiple time-points, namely 2 weeks after mastectomy, at 6 months and at 12 months following the reconstruction procedure. A linear regression model was used to account for the correlation between the three time-points within each patient||5.19|-10.57|0.05
91738891|NCT00956384|183370132|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|||We assessed the effect of the surgical method on the occurrences of any complications versus none via logistic regression, and results were expressed as odds ratios with 95% CIs.||||<0.05
91499144|NCT00555321|182868000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|95.0|-35.5|-4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.1|-35.5|
91499145|NCT00555321|182868001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-14.5|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-14.5|
91499146|NCT00555321|182868001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-25.7|8.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||8.8|-25.7|
91499147|NCT00555321|182868001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-13.2|17.5|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||17.5|-13.2|
91499148|NCT00555321|182868001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-18.1|13.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||13.1|-18.1|
91499149|NCT00555321|182868001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-29.4|6.2|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||6.2|-29.4|
91738892|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|8.89||||0.6498|TWO_SIDED|95.0|-24.65|42.42||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of C4d score||42.42|-24.65|0.6498
91499150|NCT00555321|182868001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-16.9|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-16.9|
91499151|NCT00555321|182868002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|||||TWO_SIDED|95.0|15.8|50.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||50.6|15.8|
91499152|NCT00555321|182868002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||||TWO_SIDED|95.0|11.4|46.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||46.3|11.4|
91738893|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|18.56||||0.0768|TWO_SIDED|95.0|1.43|35.68||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of margination score||35.68|1.43|0.0768
91738894|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.0||||0.6928|TWO_SIDED|95.0|-21.36|13.36||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulitis score||13.36|-21.36|0.6928
91738895|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|7.11||||0.0508|TWO_SIDED|95.0|1.23|12.99||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of vasculitis score||12.99|1.23|0.0508
91738896|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.89||||0.2042|TWO_SIDED|95.0|-11.34|1.56||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulosclerosis score||1.56|-11.34|0.2042
91738897|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.22||||0.3322|TWO_SIDED|95.0|-0.61|0.17||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic glomerulopathy score||0.17|-0.61|0.3322
91738898|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|5.67||||0.4723|TWO_SIDED|95.0|-7.77|9.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of interstitial fibrosis score||9.11|-7.77|0.4723
91738899|NCT01147302|183370135|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.56||||0.5103|TWO_SIDED|95.0|-7.25|16.37||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic vasculitis score||16.37|-7.25|0.5103
91738900|NCT01147302|183370136|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.08||||0.7591|TWO_SIDED|95.0|-0.35|0.51||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||0.51|-0.35|0.7591
91738901|NCT01147302|183370136|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.01||||0.9533|TWO_SIDED|95.0|-0.44|0.41||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||0.41|-0.44|0.9533
91738902|NCT01147302|183370137|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.45||||0.9046|TWO_SIDED|95.0|-19.34|22.24||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||22.24|-19.34|0.9046
91738903|NCT01147302|183370137|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.68||||0.5895|TWO_SIDED|95.0|-10.19|19.55||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||19.55|-10.19|0.5895
91738904|NCT01147302|183370138|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.56||||0.4558|TWO_SIDED|90.0|-2.0|5.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 20||5.11|-2.00|0.4558
91738905|NCT01147302|183370138|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.24||||0.947|TWO_SIDED|90.0|-6.05|6.52||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 90||6.52|-6.05|0.9470
91499153|NCT00555321|182868002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.2|||||TWO_SIDED|95.0|16.9|51.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||51.5|16.9|
91499154|NCT00555321|182868002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|-7.1|31.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||31.6|-7.1|
91499155|NCT00555321|182868002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|95.0|-11.5|27.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||27.2|-11.5|
91499156|NCT00555321|182868002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1|||||TWO_SIDED|95.0|-5.9|32.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||32.6|-5.9|
91499157|NCT00555321|182868003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|-5.8|36.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.8|-5.8|
91499158|NCT00555321|182868003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|-6.0|38.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||38.0|-6.0|
91499159|NCT00555321|182868003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-16.6|26.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.8|-16.6|
91499160|NCT00555321|182868003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|-10.8|36.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.1|-10.8|
91738906|NCT05076045|183370183|SUPERIORITY|||||||0.03||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Results of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in percentage of correct answers between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.03
91738907|NCT05076045|183370184|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|||Null hypothesis is that there was no difference in reaction time between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio as within-subject factors. Participants were included as a random factor.||||0.28
91499161|NCT00555321|182868003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|||||TWO_SIDED|95.0|-10.9|37.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||37.3|-10.9|
91499162|NCT00555321|182868003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-21.8|26.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.0|-21.8|
91499163|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|||||TWO_SIDED|95.0|-6.7|43.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||43.3|-6.7|
91499164|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-21.6|25.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||25.5|-21.6|
91499165|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-20.1|28.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||28.7|-20.1|
91499166|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-21.2|32.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||32.1|-21.2|
91499167|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||||TWO_SIDED|95.0|-36.0|14.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||14.2|-36.0|
91499168|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||||TWO_SIDED|95.0|-34.6|17.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.3|-34.6|
91499169|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-18.8|35.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||35.1|-18.8|
91499170|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||||TWO_SIDED|95.0|-46.3|6.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.3|-46.3|
91499171|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||||TWO_SIDED|95.0|-48.2|5.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.2|-48.2|
91499172|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|||||TWO_SIDED|95.0|-5.2|48.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||48.4|-5.2|
91738908|NCT05076045|183370185|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p = 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Quick Speech In Noise score between PSAPs and Control. The performance of the QuickSIN for the two sessions (PSAPs, Control) was compared using the Wilcoxon signed rank test on paired samples.||||0.005
91738909|NCT05076045|183370186|SUPERIORITY|||||||1||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
91738910|NCT05076045|183370187|SUPERIORITY|This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).||||||1|||||||Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
91738911|NCT05076045|183370188|SUPERIORITY|||||||0.36||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.36
91738912|NCT05076045|183370189|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05 (two-sided).|Cumulative link mixed model|||Null hypothesis is that there was no difference in listening effort between PSAPs and Control. The listening effort score was analyzed using a cumulative link mixed model. A logit link function with flexible thresholds was used. The model included Session (PSAPs, Control) and Block (1, 2, 3) as within-subject factors. Participants were included as a random factor.||||<0.001
91738913|NCT00038948|183370201|SUPERIORITY_OR_OTHER||Weighted difference|-2.68||||0.575||95.0|-12.27|6.91||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of 20.0 to 40.0 mL/min||6.91|-12.27|0.575
91738914|NCT00038948|183370201|SUPERIORITY_OR_OTHER||Weighted difference|1.31||||0.278||95.0|-1.06|3.69||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of \>40.0 mL/min||3.69|-1.06|0.278
91738915|NCT00038948|183370202|SUPERIORITY_OR_OTHER|||||||0.135||||||Tests the equality of rates between treatments across strata at 52 weeks.|Cochran-Mantel-Haenszel|||52 weeks statistical analysis across strata||||0.135
91738916|NCT00038948|183370202|SUPERIORITY_OR_OTHER|||||||0.559||||||Tests the equality of rates between treatments across strata at 104 weeks.|Cochran-Mantel-Haenszel|||104 weeks statistical analysis across strata||||0.559
91738917|NCT05270863|183370203|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<.001
91738918|NCT03531814|183370218|OTHER|||||||0.006||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 1-4.|ANOVA|||||||0.006
91738919|NCT03531814|183370218|OTHER|||||||0.021||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 5-8.|ANOVA|||||||0.021
91531053|NCT00653263|182938405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
91738920|NCT03531814|183370218|OTHER|||||||0.034||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 9-12.|ANOVA|||||||.034
91738921|NCT03531814|183370218|OTHER|||||||0.04||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 13-18.|ANOVA|||||||.040
91738922|NCT03531814|183370219|OTHER||Spearman's correlation|-0.21||||0.536|TWO_SIDED|95.0|-0.729|0.463||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.463|-0.729|0.536
91738923|NCT03531814|183370219|OTHER||Spearman's correlation|0.134||||0.713|TWO_SIDED|95.0|-0.557|0.715||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.715|-0.557|.713
91738924|NCT03531814|183370219|OTHER||Spearman's correlation|0.095||||0.823|TWO_SIDED|95.0|-0.668|0.761||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.761|-0.668|.823
91738925|NCT03531814|183370219|OTHER||Spearman's correlation|0.333||||0.42|TWO_SIDED|95.0|-0.505|0.848||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.848|-0.505|.420
91738926|NCT03531814|183370220|OTHER||Spearman's correlation|-0.333||||0.317|TWO_SIDED|95.0|-0.785|0.352||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.352|-0.785|0.317
91738927|NCT03531814|183370220|OTHER||Spearman's correlation|-0.309||||0.385|TWO_SIDED|95.0|-0.794|0.416||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.416|-0.794|.385
91738928|NCT03531814|183370220|OTHER||Spearman's correlation|-0.259||||0.535|TWO_SIDED|95.0|-0.824|0.563||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.563|-0.824|.535
91738929|NCT03531814|183370220|OTHER||Spearman's correlation|-0.222||||0.597|TWO_SIDED|95.0|-0.811|0.589||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.589|-0.811|.597
91738930|NCT03531814|183370221|OTHER||Spearman's correlation|-0.215||||0.526|TWO_SIDED|95.0|-0.731|0.459||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.459|-0.731|0.526
91738931|NCT03531814|183370221|OTHER||Spearman's correlation|0.049||||0.894|TWO_SIDED|95.0|-0.613|0.67||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.670|-0.613|.894
91738932|NCT03531814|183370221|OTHER||Spearman's correlation|-0.048||||0.911|TWO_SIDED|95.0|-0.74|0.694||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12|Spearman correlation (non-parametric)|||||0.694|-0.740|.911
91738933|NCT03531814|183370221|OTHER||Spearman's correlation|-0.167||||0.693|TWO_SIDED|95.0|-0.79|0.626||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18|Spearman correlation (non-parametric)|||||0.626|-0.790|.693
91738934|NCT03531814|183370222|OTHER||Spearman's correlation|-0.607||||0.048|TWO_SIDED|95.0|-0.889|0.009||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.009|-0.889|0.048
91738935|NCT03531814|183370222|OTHER||Spearman's correlation|-0.658||||0.038|TWO_SIDED|95.0|-0.914|-0.027||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||-0.027|-0.914|0.038
91738936|NCT03531814|183370222|OTHER||Spearman's correlation|-0.708||||0.5|TWO_SIDED|95.0|-0.945|0.02||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.020|-0.945|0.50
91738937|NCT03531814|183370222|OTHER||Spearman's correlation|-0.878||||0.004|TWO_SIDED|95.0|-0.979|-0.435||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.435|-0.979|0.004
91738938|NCT03531814|183370223|OTHER||Spearman's correlation|0.293||||0.382|TWO_SIDED|95.0|-0.39|0.768||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.768|-0.390|0.382
91738939|NCT03531814|183370223|OTHER||Spearman's correlation|0.278||||0.436|TWO_SIDED|95.0|-0.444|0.781||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.781|-0.444|0.436
91738940|NCT03531814|183370223|OTHER||Spearman's correlation|0.229||||0.586|TWO_SIDED|95.0|-0.585|0.813||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.813|-0.585|0.586
91738941|NCT03531814|183370223|OTHER||Spearman's correlation|0.53||||0.177|TWO_SIDED|95.0|-0.302|0.904||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.904|-0.302|0.177
91738942|NCT03531814|183370225|OTHER||Spearman's correlation|-0.576||||0.063|TWO_SIDED|95.0|-0.879|0.056||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.056|-0.879|0.063
91738943|NCT03531814|183370225|OTHER||Spearman's correlation|-0.68||||0.031|TWO_SIDED|95.0|-0.92|-0.066||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Wilcoxon (Mann-Whitney)|||||-0.066|-0.920|0.031
91738944|NCT03531814|183370225|OTHER||Spearman's correlation|-0.835||||0.01|TWO_SIDED|95.0|-0.971|-0.292||The reported p-value represents the strength of the relationship between the variables at cycles 9-12.|Spearman correlation (non-parametric)|||||-0.292|-0.971|0.010
91499173|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-32.9|19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.8|-32.9|
91499174|NCT00555321|182868027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9|||||TWO_SIDED|95.0|-34.8|18.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||18.7|-34.8|
91738945|NCT03531814|183370225|OTHER||Spearman's correlation|-0.933|||<|0.001|TWO_SIDED|95.0|-0.989|-0.652||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.652|-0.989|<0.001
91738946|NCT03531814|183370226|OTHER||Spearman's correlation|-0.035||||0.919|TWO_SIDED|95.0|-0.634|0.591||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||0.591|-0.634|0.919
91738947|NCT03531814|183370226|OTHER||Spearman's correlation|0.227||||0.528|TWO_SIDED|95.0|-0.487|0.759||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.759|-0.487|0.528
91738948|NCT03531814|183370226|OTHER||Spearman's correlation|0.179||||0.672|TWO_SIDED|95.0|-0.618|0.794||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.794|-0.618|0.672
91738949|NCT03531814|183370226|OTHER||Spearman's correlation|0.041||||0.923|TWO_SIDED|95.0|-0.697|0.737||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.737|-0.697|0.923
91738950|NCT03531814|183370227|OTHER||Spearman's correlation|-0.638||||0.035|TWO_SIDED|95.0|-0.899|-0.041||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||-0.041|-0.899|0.035
91499175|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||||TWO_SIDED|95.0|-42.4|26.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||26.3|-42.4|
91738951|NCT03531814|183370227|OTHER||Spearman's correlation|-0.361||||0.306|TWO_SIDED|95.0|-0.815|0.367||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.367|-0.815|0.306
91738952|NCT03531814|183370227|OTHER||Spearman's correlation|-0.407||||0.317|TWO_SIDED|95.0|-0.87|0.438||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.438|-0.870|0.317
91738953|NCT03531814|183370227|OTHER||Spearman's correlation|-0.18||||0.67|TWO_SIDED|95.0|-0.795|0.0617||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.0617|-0.795|0.670
91738954|NCT01415583|183370244|NON_INFERIORITY|Consistent with the noninferiority design, the null hypothesis states that the bleeding rate in patients receiving perioperative dexamethasone differed from the bleeding rate in patients receiving perioperative placebo; the alternative hypothesis states that the bleeding rate with dexamethasone is not greater than placebo by more than the noninferiority margin.||||||0.05|||||||t-test, 1 sided|||||||0.05
91738955|NCT01415583|183370244|NON_INFERIORITY|This noninferiority margin was set at 5%, meaning a difference in bleeding rates that did not exceed 5% would be taken as evidence that the bleeding with dexamethasone is not greater than that with placebo by more than 5%.||||||0.05|||||||t-test, 1 sided|||||||0.05
91738956|NCT04472650|183370250|OTHER||Ratio of Geometric Least Squares Means|87.63|||||TWO_SIDED|90.0|78.273|98.111||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.111|78.273|
91738957|NCT04472650|183370251|OTHER||Ratio of Geometric Least Squares Means|87.5|||||TWO_SIDED|90.0|78.12|98.01||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.01|78.12|
91738958|NCT04472650|183370252|OTHER||Ratio of Geometric Least Squares Means|88.8|||||TWO_SIDED|90.0|77.41|101.87||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||101.87|77.41|
91738959|NCT01861665|183370258|SUPERIORITY|||||||0.8379||||||Pre Incision vs. Post Incision on Post op day 0.|t-test, 2 sided|||||||0.8379
91738960|NCT01861665|183370258|SUPERIORITY|||||||0.7263||||||Pre incision vs. Post incision post op day 1.|t-test, 2 sided|||||||0.7263
91499176|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||||TWO_SIDED|95.0|-49.2|19.0|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||19.0|-49.2|
91499177|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.8|||||TWO_SIDED|95.0|-81.6|-19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-19.8|-81.6|
91499178|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||16.9|-55.9|
91531054|NCT04145349|182938430|SUPERIORITY||Posterior Mean Hazard Ratio|0.69|||||TWO_SIDED|98.0|0.25|1.69|||Bayesian hierarchical model|||The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.|The posterior probability treatment difference is 0.864|1.69|0.25|
91738961|NCT01861665|183370258|SUPERIORITY|||||||0.5||||||Pre incision vs. Post incision day 2.|t-test, 2 sided|||||||0.5
91738962|NCT03247829|183370259|OTHER|||||||0.001|||||||t-test, 2 sided|Comparative p-values were calculated by two-sided t-tests (paired analysis).||||||0.001
91738963|NCT03247829|183370260|OTHER|||||||0.0931|||||||t-test, 2 sided|||||||0.0931
91738964|NCT01783444|183370268|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.74|||||TWO_SIDED|90.0|0.57|0.97||||||||0.97|0.57|
91738965|NCT01783444|183370269|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.96|1.66||||||||1.66|0.96|
91738966|NCT01783444|183370270|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.27|||||TWO_SIDED|90.0|0.95|1.7||||||||1.70|0.95|
91738967|NCT01783444|183370270|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.99|1.79||||||||1.79|0.99|
91738968|NCT01783444|183370273|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.09|||||TWO_SIDED|90.0|0.72|1.66||||||||1.66|0.72|
91738969|NCT01783444|183370273|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.18|||||TWO_SIDED|90.0|0.78|1.77||||||||1.77|0.78|
91738970|NCT01783444|183370274|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.64|||||TWO_SIDED|90.0|0.46|0.88||||||||0.88|0.46|
91738971|NCT01783444|183370274|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.93|1.91||||||||1.91|0.93|
91738972|NCT01783444|183370275|OTHER||Mean Difference (Net)|4.3|||||TWO_SIDED|90.0|-3.3|11.9||||||Side-effects||11.9|-3.3|
91738973|NCT01783444|183370275|OTHER||Mean Difference (Net)|-2.2|||||TWO_SIDED|90.0|-9.9|5.5||||||Side-effects||5.5|-9.9|
91738974|NCT01783444|183370275|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-10.4|3.8||||||Effectiveness||3.8|-10.4|
91738975|NCT01783444|183370275|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-9.7|3.0||||||Effectiveness||3.0|-9.7|
91738976|NCT01783444|183370275|OTHER||Mean Difference (Net)|-1.6|||||TWO_SIDED|90.0|-5.8|2.5||||||Convenience||2.5|-5.8|
91499179|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|||||TWO_SIDED|95.0|-62.6|9.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||9.4|-62.6|
91499180|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.7|||||TWO_SIDED|95.0|-94.0|-33.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-33.1|-94.0|
91499181|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-32.6|34.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||34.3|-32.6|
91531055|NCT05567952|182938437|SUPERIORITY||Least square (LS) mean difference|-0.705|||=|0.0004|TWO_SIDED|95.0|-1.093|-0.316|||MMRM|||Mixed model for repeated measures (MMRM) included fixed effects of treatment, geographic region, baseline SARS-CoV-2 RNA level, visit, and treatment-by-visit interaction; an unstructured (co) variance structure was used.||-0.316|-1.093|= 0.0004
91738977|NCT01783444|183370275|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|90.0|-5.5|3.3||||||Convenience||3.3|-5.5|
91738978|NCT01783444|183370275|OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|90.0|-8.3|2.9||||||Global Satisfaction||2.9|-8.3|
91738979|NCT01783444|183370275|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-8.4|1.9||||||Global Satisfaction||1.9|-8.4|
91499182|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||||TWO_SIDED|95.0|-47.4|20.6|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||20.6|-47.4|
91499183|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.5|||||TWO_SIDED|95.0|-72.6|0.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||0.5|-72.6|
91738980|NCT02722408|183370277|OTHER|||||||0.0041||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0041
91738981|NCT02722408|183370278|OTHER|||||||0.001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0010
91738982|NCT02722408|183370279|OTHER|||||||0.0012||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0012
91738983|NCT02722408|183370280|OTHER|||||||0.056||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0560
91738984|NCT02722408|183370280|OTHER|||||||0.0219||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0219
91738985|NCT02722408|183370280|OTHER|||||||0.0286||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0286
91738986|NCT02722408|183370281|OTHER|||||||0.0058||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0058
91738987|NCT02722408|183370281|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0019
91499184|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-41.1|31.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||31.1|-41.1|
91499185|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||16.9|-55.9|
91499186|NCT00555321|182868028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.5|||||TWO_SIDED|95.0|-81.9|-3.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||-3.5|-81.9|
91499187|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-21.2|6.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||6.0|-21.2|
91499188|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||5.3|-18.2|
91705122|NCT01217385|183304732|EQUIVALENCE|test for the equivalence of %change in TOI ratio (dichotomized at \<=-40%), between PR+ and PR- groups, with interaction|Slope|0.4463|STANDARD_ERROR_OF_MEAN|1.953||0.8193|TWO_SIDED|||||significance at alpha=0.05|Regression, Logistic|p-value represents the interaction between %TOI (dichotomized at \<=-40%), and PR status|Multivariate logistic regression model using % change in TOI ratio (T/N) (baseline to mid-therapy) dichotomized at -40%, PR status, and the corresponding interaction.|The Null is that the odd ratio is the same in both the PR+ and PR- subjects fro the model including %change in TOI form baseline to mid-therapy (dichotomized at \<=-40%), PR status (+/-) and the interaction between them.||||0.8193
91705123|NCT01217385|183304733|OTHER||Odds Ratio (OR)|16.5||||0.043|TWO_SIDED|95.0|1.09|250.15|||Regression, Logistic|||||250.15|1.09|0.043
91531056|NCT05567952|182938438|SUPERIORITY||Hazard Ratio (HR)|1.235|||=|0.0697|TWO_SIDED|95.0|0.983|1.551|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (less than or equal to \[\<=6\] months, \> 6 months or unvaccinated) as appropriate.||1.551|0.983|= 0.0697
91705124|NCT01217385|183304733|OTHER||Odds Ratio (OR)|2.86||||0.406|TWO_SIDED|95.0|0.24|33.9|||Regression, Logistic|||||33.90|0.24|0.406
91738988|NCT02722408|183370281|OTHER|||||||0.0024||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0024
91738989|NCT02722408|183370282|OTHER|||||||0.0592||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0592
91738990|NCT02722408|183370282|OTHER|||||||0.0266||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0266
91738991|NCT02722408|183370282|OTHER|||||||0.0336||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0336
91738992|NCT02722408|183370283|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
91738993|NCT02722408|183370283|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0017
91738994|NCT02722408|183370283|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0017
91499189|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-14.9|
91705125|NCT02117713|183304770|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-28.59|STANDARD_DEVIATION|89.456||0.1157|TWO_SIDED|95.0|-64.72|7.54|||Student's t-test||Difference is only calculated in participants who had baseline and week 48 values for n= 26|||7.54|-64.72|0.1157
91705126|NCT02117713|183304771|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-45.15|STANDARD_DEVIATION|89.934||0.1469|TWO_SIDED|95.0|-109.48|19.19|||Student's t-test||||Difference is only calculated in participants who had baseline and week 216 values for n=10|19.19|-109.48|0.1469
91705127|NCT02117713|183304772|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-2.353|STANDARD_DEVIATION|0.7124||0.005|TWO_SIDED|95.0|-3.101|-1.606|||Student's t-test||Difference is only calculated in participants who had baseline and week 218 values for n=6|||-1.606|-3.101|0.005
91738995|NCT02722408|183370284|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
91738996|NCT02722408|183370284|OTHER|||||||0.0255||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0255
91738997|NCT02722408|183370284|OTHER|||||||0.0312||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 86||||0.0312
91738998|NCT02722408|183370285|OTHER|||||||0.4489||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4489
91738999|NCT02722408|183370285|OTHER|||||||0.5964||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.5964
91499190|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-25.1|7.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||7.1|-25.1|
91499191|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-15.6|
91531057|NCT05567952|182938439|SUPERIORITY||Hazard Ratio (HR)|1.084|||=|0.5202|TWO_SIDED|95.0|0.848|1.385|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (\<=6 months, \> 6 months or unvaccinated) as appropriate.||1.385|0.848|= 0.5202
91739000|NCT02722408|183370285|OTHER|||||||0.6785||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6785
91739001|NCT02722408|183370286|OTHER|||||||0.2177||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2177
91739002|NCT02722408|183370286|OTHER|||||||0.3209||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3209
91739003|NCT02722408|183370286|OTHER|||||||0.3101||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3101
91531058|NCT03280563|182938443|SUPERIORITY||Difference in Overall Response Rates|0.0|||||TWO_SIDED|95.0|-21.14|21.14||||||||21.14|-21.14|
91739004|NCT02722408|183370287|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
91739005|NCT02722408|183370287|OTHER|||||||0.0022||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0022
91499192|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||3.9|-12.7|
91499193|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
91531059|NCT03280563|182938443|SUPERIORITY||Difference in Overall Response Rates|16.92|||||TWO_SIDED|95.0|-9.03|42.88||||||||42.88|-9.03|
91739006|NCT02722408|183370287|OTHER|||||||0.0029||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0029
91739007|NCT02722408|183370288|OTHER|||||||0.0008||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0008
91739008|NCT02722408|183370288|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.0005
91739009|NCT02722408|183370288|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.0002
91739010|NCT02722408|183370289|OTHER|||||||0.4103||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4103
91739011|NCT02722408|183370289|OTHER|||||||0.6164||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6164
91739012|NCT02722408|183370289|OTHER|||||||0.6732||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6732
91739013|NCT02722408|183370290|OTHER|||||||0.2003||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2003
91531060|NCT03280563|182938443|SUPERIORITY||Difference in Overall Response Rates|6.67|||||TWO_SIDED|95.0|-36.76|50.09||||||||50.09|-36.76|
91739014|NCT02722408|183370290|OTHER|||||||0.3323||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3323
91739015|NCT02722408|183370290|OTHER|||||||0.3047||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3047
91739016|NCT02722408|183370291|OTHER|||||||0.3601||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3601
91739017|NCT02722408|183370291|OTHER|||||||0.192||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1920
91739018|NCT02722408|183370291|OTHER|||||||0.2912||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2912
91739019|NCT02722408|183370291|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||<0.0001
91531061|NCT03280563|182938443|SUPERIORITY||Difference in Overall Response Rates|-3.33|||||TWO_SIDED|95.0|-27.39|20.73||||||||20.73|-27.39|
91739020|NCT02722408|183370291|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||<0.0001
91739021|NCT02722408|183370291|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
91739022|NCT02722408|183370291|OTHER|||||||0.0444||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0444
91739023|NCT02722408|183370291|OTHER|||||||0.0159||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0159
91739024|NCT02722408|183370291|OTHER|||||||0.0235||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0235
91705128|NCT02117713|183304773|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|56.0|STANDARD_DEVIATION|119.32||0.2607|TWO_SIDED|95.0|-54.4|166.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||166.4|-54.4|0.2607
91705129|NCT02117713|183304774|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-141.6|STANDARD_DEVIATION|216.25||0.134|TWO_SIDED|95.0|-341.6|58.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||58.4|-341.6|0.1340
91705130|NCT02117713|183304775|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|47.6|STANDARD_DEVIATION|75.68||0.1474|TWO_SIDED|95.0|-22.4|117.6|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||117.6|-22.4|0.1474
91739025|NCT02722408|183370291|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0005
91739026|NCT02722408|183370291|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
91739027|NCT02722408|183370291|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
91739028|NCT02722408|183370292|OTHER|||||||0.3646||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3646
91739029|NCT02722408|183370292|OTHER|||||||0.1994||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1994
91739030|NCT02722408|183370292|OTHER|||||||0.2858||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2858
91739031|NCT02722408|183370292|OTHER|||||||0.0829||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0829
91739032|NCT02722408|183370292|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0492
91705131|NCT02117713|183304776|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.58||1|TWO_SIDED|95.0|-0.5|0.5|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.5|-0.5|1.00
91739033|NCT02722408|183370292|OTHER|||||||0.0442||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0442
91739034|NCT02722408|183370292|OTHER|||||||0.736||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.7360
91739035|NCT02722408|183370292|OTHER|||||||0.6917||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.6917
91739036|NCT02722408|183370292|OTHER|||||||0.7131||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.7131
91739037|NCT02722408|183370292|OTHER|||||||0.0014||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0014
91739038|NCT02722408|183370292|OTHER|||||||0.0009||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0009
91739039|NCT02722408|183370292|OTHER|||||||0.0007||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0007
91739040|NCT02722408|183370293|OTHER|||||||0.388||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3880
91531062|NCT03280563|182938443|SUPERIORITY||Difference in Overall Response Rates|16.32|||||TWO_SIDED|95.0|-6.71|39.34||||||||39.34|-6.71|
91531063|NCT03280563|182938444|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.5|1.66||||||||1.66|0.50|
91499194|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.3|-18.2|
91531064|NCT03280563|182938444|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.35|1.2||||||||1.20|0.35|
91739041|NCT02722408|183370293|OTHER|||||||0.2057||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2057
91739042|NCT02722408|183370293|OTHER|||||||0.2892||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2892
91739043|NCT02722408|183370293|OTHER|||||||0.0052||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0052
91739044|NCT02722408|183370293|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.0028
91739045|NCT02722408|183370293|OTHER|||||||0.0026||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.0026
91739046|NCT02722408|183370293|OTHER|||||||0.0493||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0493
91739047|NCT02722408|183370293|OTHER|||||||0.0253||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0253
91739048|NCT02722408|183370293|OTHER|||||||0.0394||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0394
91739049|NCT02722408|183370293|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
91739050|NCT02722408|183370293|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
91739051|NCT02722408|183370293|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
91739052|NCT02722408|183370294|OTHER|||||||0.3833||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3833
91739053|NCT02722408|183370294|OTHER|||||||0.2172||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2172
91739054|NCT02722408|183370294|OTHER|||||||0.293||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2930
91739055|NCT02722408|183370294|OTHER|||||||0.1217||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1217
91739056|NCT02722408|183370294|OTHER|||||||0.0901||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0901
91739057|NCT02722408|183370294|OTHER|||||||0.085||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0850
91531065|NCT03280563|182938444|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.45|3.48||||||||3.48|0.45|
91739058|NCT02722408|183370294|OTHER|||||||0.0747||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0747
91739059|NCT02722408|183370294|OTHER|||||||0.0279||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0279
91739060|NCT02722408|183370294|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0492
91499195|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-14.9|
91499196|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
91531066|NCT03280563|182938444|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.74|3.23||||||||3.23|0.74|
91705132|NCT02117713|183304777|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.38||0.0167|TWO_SIDED|95.0|-3.0|-0.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||-0.4|-3|0.0167
91705133|NCT02117713|183304778|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|10.9|STANDARD_DEVIATION|245.92||0.9108|TWO_SIDED|95.0|-216.6|238.3|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||238.3|-216.6|0.9108
91705134|NCT02117713|183304779|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant(null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.1207|STANDARD_DEVIATION|1.882||0.1207|TWO_SIDED|95.0|-3.03|0.45|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.45|-3.03|0.1207
91705135|NCT02117713|183304780|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-0.943|STANDARD_DEVIATION|1.2488||0.0927|TWO_SIDED|95.0|-2.098|0.212|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.212|-2.098|0.0927
91705136|NCT00672841|183304781|SUPERIORITY_OR_OTHER||Sensitivity|100.0||||||95.0|||||Sensitivity %||Sensitivity \[1\] = (True positives \[n=6\]/ True positives + False negatives \[n=6\])|Clinical sensitivity of the BDG test was calculated for both study groups combined||||
91705137|NCT00672841|183304781|SUPERIORITY_OR_OTHER||Specificity|50.0||||||95.0|||||% Specificity||Specificity \[0.50\]= True negatives \[n=28\]/ True negatives + False positives \[56\])|Clinical specificity of the BDG test was calculated for the study groups combined||||
91705138|NCT00672841|183304783|SUPERIORITY_OR_OTHER||Percent Sensitivity|100.0||||||95.0|||||Sensitivity||Sensitivity = (true positives \[n=6\]/true positives + false negative \[n=6\])|The clinic sensitivity of the BDG test was calculated for both study groups combined||||
91705139|NCT00672841|183304783|SUPERIORITY_OR_OTHER||Percent Specificity|52.0||||||95.0|||||Specificity||Specificity \[0.52\]= (True negatives \[n=30\]/True negatives + false positives \[n=58\])|The clinical specificity of the BDG test was calculated for both study groups combined||||
91705140|NCT03578146|183304785|SUPERIORITY||Least Squares Means (Difference)|-73.14||||0.0121|TWO_SIDED||||||ANCOVA|||||||0.0121
91705141|NCT03578146|183304785|SUPERIORITY||Least Squares Means (Difference)|-153.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705142|NCT03578146|183304785|SUPERIORITY||Least Squares Means (Difference)|-189.57|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705143|NCT03578146|183304785|SUPERIORITY||Least Squares Means (Difference)|-239.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705144|NCT03578146|183304785|SUPERIORITY||Least Squares Means (Difference)|-231.12|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705145|NCT03578146|183304786|SUPERIORITY||Least Squares Means (Difference)|52837.94|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705146|NCT03578146|183304786|SUPERIORITY||Least Squares Means (Difference)|110388.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705147|NCT03578146|183304786|SUPERIORITY||Least Squares Means (Difference)|163880.7|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705148|NCT03578146|183304786|SUPERIORITY||Least Squares Means (Difference)|263236.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705149|NCT03578146|183304786|SUPERIORITY||Least Squares Means (Difference)|270297.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705150|NCT03578146|183304787|SUPERIORITY||Least Squares Means (Difference)|-9.91||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
91705151|NCT03578146|183304787|SUPERIORITY||Least Squares Means (Difference)|-15.06|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705152|NCT03578146|183304787|SUPERIORITY||Least Squares Means (Difference)|-17.53|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91531067|NCT03280563|182938444|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.28|0.88||||||||0.88|0.28|
91531068|NCT03280563|182938446|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.36|1.65||||||||1.65|0.36|
91705153|NCT03578146|183304787|SUPERIORITY||Least Squares Means (Difference)|-17.05|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705154|NCT03578146|183304787|SUPERIORITY||Least Squares Means (Difference)|-19.33|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91705155|NCT02503254|183304817|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|82.82|||<|0.001|TWO_SIDED|95.0|78.79|86.09||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||86.09|78.79|<.001
91499197|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-15.6|
91499198|NCT00555321|182868041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||3.9|-12.7|
91499199|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-25.6|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-25.6|
91739061|NCT02722408|183370294|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
91739062|NCT02722408|183370294|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
91739063|NCT02722408|183370294|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
91739064|NCT02722408|183370295|OTHER|||||||0.8972||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8972
91739065|NCT02722408|183370295|OTHER|||||||0.7867||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7867
91739066|NCT02722408|183370295|OTHER|||||||0.4974||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4974
91739067|NCT02722408|183370295|OTHER|||||||0.5464||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5464
91499200|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-11.7|22.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||22.3|-11.7|
91499201|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-20.1|15.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||15.2|-20.1|
91531069|NCT03280563|182938446|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.34|1.58||||||||1.58|0.34|
91739068|NCT02722408|183370295|OTHER|||||||0.7668||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7668
91739069|NCT02722408|183370295|OTHER|||||||0.9276||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9276
91739070|NCT02722408|183370295|OTHER|||||||0.5821||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.5821
91739071|NCT02722408|183370295|OTHER|||||||0.8881||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.8881
91739072|NCT02722408|183370295|OTHER|||||||0.8525||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8525
91531070|NCT03280563|182938446|SUPERIORITY||Hazard Ratio (HR)|2.26|||||TWO_SIDED|95.0|0.55|9.34||||||||9.34|0.55|
91739073|NCT02722408|183370295|OTHER|||||||0.0112||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0112
91739074|NCT02722408|183370295|OTHER|||||||0.0018||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0018
91739075|NCT02722408|183370295|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0028
91739076|NCT02722408|183370296|OTHER|||||||0.8985||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8985
91499202|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-24.0|12.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||12.5|-24.0|
91499203|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-10.5|24.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||24.2|-10.5|
91739077|NCT02722408|183370296|OTHER|||||||0.7664||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7664
91531071|NCT03280563|182938446|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.28|2.01||||||||2.01|0.28|
91531072|NCT03280563|182938446|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.35|1.46||||||||1.46|0.35|
91739078|NCT02722408|183370296|OTHER|||||||0.4755||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4755
91739079|NCT02722408|183370296|OTHER|||||||0.2286||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2286
91739080|NCT02722408|183370296|OTHER|||||||0.3975||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3975
91739081|NCT02722408|183370296|OTHER|||||||0.446||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4460
91739082|NCT02722408|183370296|OTHER|||||||0.9414||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9414
91739083|NCT02722408|183370296|OTHER|||||||0.9735||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9735
91739084|NCT02722408|183370296|OTHER|||||||0.9825||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9825
91739085|NCT02722408|183370296|OTHER|||||||0.442||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4420
91739086|NCT02722408|183370296|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
91739087|NCT02722408|183370296|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
91739088|NCT02722408|183370297|OTHER|||||||0.2305||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2305
91739089|NCT02722408|183370297|OTHER|||||||0.1836||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1836
91739090|NCT02722408|183370297|OTHER|||||||0.6501||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6501
91739091|NCT02722408|183370297|OTHER|||||||0.0139||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0139
91739092|NCT02722408|183370297|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0077
91739093|NCT02722408|183370297|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
91739094|NCT02722408|183370297|OTHER|||||||0.0507||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0507
91499204|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-18.5|17.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.6|-18.5|
91499205|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.3|9.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||9.4|-23.3|
91705156|NCT02503254|183304818|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|63.53|||<|0.001|TWO_SIDED|95.0|59.55|67.12||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively"||67.12|59.55|<0.001
91705157|NCT02503254|183304819|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|88.14|||<|0.001|TWO_SIDED|95.0|86.46|89.62||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||89.62|86.46|<.001
91705158|NCT02503254|183304820|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|58.83|||<|0.001|TWO_SIDED|95.0|49.3|66.56||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC respectively."||66.56|49.30|<.001
91705159|NCT01524783|183304834|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.35|0.67|||Log Rank|||||0.67|0.35|<0.001
91705160|NCT01524783|183304835|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.259|TWO_SIDED|95.0|0.66|1.24|||Log Rank|||||1.24|0.66|0.259
91705161|NCT01524783|183304838|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.073|TWO_SIDED|95.0|0.5|1.1|||Log Rank|||||1.10|0.50|0.073
91705162|NCT01524783|183304841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.539|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.539
91705163|NCT01625689|183304847|SUPERIORITY_OR_OTHER||||||>=|0.498|TWO_SIDED|||||No comparison between the LAIV and placebo groups by type of solicited reaction had a p-value below 0.498.|Fisher Exact|||||||>=0.498
91705164|NCT00824434|183304875|SUPERIORITY_OR_OTHER||Mean In-stent Late Loss in WH Lesions|0.17|||<|0.0001|ONE_SIDED|95.0||0.22|||t-test, 1 sided|||The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)||0.22||<0.0001
91705165|NCT00824434|183304876|SUPERIORITY_OR_OTHER||Percent Post-procedure Incomplete Apposi|5.7|||<|0.0001|ONE_SIDED|95.0||11.6|||One-sided exact binomial test|||A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).||11.6||<0.0001
91739095|NCT02722408|183370297|OTHER|||||||0.0118||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0118
91739096|NCT02722408|183370297|OTHER|||||||0.0122||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0122
91739097|NCT02722408|183370297|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0077
91739098|NCT02722408|183370297|OTHER|||||||0.0317||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0317
91739099|NCT02722408|183370297|OTHER|||||||0.0473||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0473
91531073|NCT03280563|182938447|SUPERIORITY||Difference in Event Free Rate|-0.75|||||TWO_SIDED|95.0|-30.98|29.48||||||||29.48|-30.98|
91531074|NCT03280563|182938447|SUPERIORITY||Difference in Event Free Rate|17.7|||||TWO_SIDED|95.0|-10.84|46.23||||||||46.23|-10.84|
91499206|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-27.4|6.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.5|-27.4|
91499207|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||||TWO_SIDED|95.0|-37.5|-2.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-2.7|-37.5|
91499208|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-15.5|19.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.7|-15.5|
91499209|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-19.4|16.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||16.9|-19.4|
91499210|NCT00555321|182868042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-29.3|7.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.9|-29.3|
91499211|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-6.3|36.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||36.0|-6.3|
91499212|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-23.4|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-23.4|
91499213|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.4|10.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.0|-23.4|
91499214|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-22.0|23.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||23.4|-22.0|
91499215|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|||||TWO_SIDED|95.0|-38.6|-0.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-0.1|-38.6|
91499216|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||||TWO_SIDED|95.0|-39.1|-1.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-1.8|-39.1|
91531075|NCT03280563|182938447|SUPERIORITY||Difference in Event Free Rate|11.85|||||TWO_SIDED|95.0|-26.63|50.33||||||||50.33|-26.63|
91531076|NCT03280563|182938447|SUPERIORITY||Difference in Event Free Rate|10.49|||||TWO_SIDED|95.0|-16.96|37.95||||||||37.95|-16.96|
91499217|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|-8.7|34.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||34.0|-8.7|
91499218|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-25.2|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-25.2|
91499219|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||||TWO_SIDED|95.0|-26.3|7.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.7|-26.3|
91499220|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-24.5|21.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12.||21.1|-24.5|
91739100|NCT02722408|183370298|OTHER|||||||0.2143||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2143
91739101|NCT02722408|183370298|OTHER|||||||0.1874||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1874
91739102|NCT02722408|183370298|OTHER|||||||0.6731||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6731
91739103|NCT02722408|183370298|OTHER|||||||0.0027||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0027
91739104|NCT02722408|183370298|OTHER|||||||0.002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0020
91499221|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||||TWO_SIDED|95.0|-40.5|-1.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-1.9|-40.5|
91499222|NCT00555321|182868049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||||TWO_SIDED|95.0|-41.8|-4.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.3|-41.8|
91499223|NCT02480439|182868065|SUPERIORITY_OR_OTHER||Point Estimate|0.966|||||TWO_SIDED|90.0|0.8747|1.0668|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0668|0.8747|
91499224|NCT02480439|182868065|SUPERIORITY_OR_OTHER||Point Estimate|0.9223|||||TWO_SIDED|90.0|0.8352|1.0185|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0185|0.8352|
91499225|NCT02480439|182868066|SUPERIORITY_OR_OTHER||Point Estimate|0.9998|||||TWO_SIDED|90.0|0.954|1.0477|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0477|0.9540|
91739105|NCT02722408|183370298|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
91739106|NCT02722408|183370298|OTHER|||||||0.0258||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0258
91531077|NCT03280563|182938448|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.15|7.9||||||||7.90|0.15|
91739107|NCT02722408|183370298|OTHER|||||||0.0044||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0044
91739108|NCT02722408|183370298|OTHER|||||||0.0011||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0011
91739109|NCT02722408|183370298|OTHER|||||||0.0083||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0083
91531078|NCT03280563|182938448|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.15|4.2||||||||4.20|0.15|
91531079|NCT03280563|182938448|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.15|3.84||||||||3.84|0.15|
91739110|NCT02722408|183370298|OTHER|||||||0.0314||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0314
91739111|NCT02722408|183370298|OTHER|||||||0.0533||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0533
91499226|NCT02480439|182868066|SUPERIORITY_OR_OTHER||Point Estimate|1.0149|||||TWO_SIDED|90.0|0.9685|1.0636|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0636|0.9685|
91499227|NCT02480439|182868067|SUPERIORITY_OR_OTHER||Point Estimate|0.9992|||||TWO_SIDED|90.0|0.9541|1.0464|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0464|0.9541|
91499228|NCT02480439|182868067|SUPERIORITY_OR_OTHER||Point Estimate|1.0134|||||TWO_SIDED|90.0|0.9676|1.0612|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0612|0.9676|
91499229|NCT00824512|182868101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9133|TWO_SIDED|95.0||||No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.|Non parametric ANCOVA on the rank test|The baseline value was used as a covariate.||||||0.9133
91499230|NCT02622321|182868131|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.057|0.277||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (less than \[\<\] 9 or greater than or equal to \[\>/=\] 9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.277|0.057|<0.0001
91499231|NCT02622321|182868132|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.102|0.375||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.375|0.102|<0.0001
91499232|NCT02622321|182868133|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.055|0.218||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.218|0.055|<0.0001
91499233|NCT02622321|182868134|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.031|0.198||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.198|0.031|<0.0001
91531080|NCT03850444|182938506|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.38|1.0|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.00|0.38|
91705166|NCT05153148|183304895|SUPERIORITY||Risk Difference (RD)|5.9|||=|0.446|TWO_SIDED|95.0|-9.3|21.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel (MH) risk difference was summarized along with the 2-sided 95% confidence interval (CI) using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional disease-modifying antirheumatic drugs (DMARDs) and region.|21.1|-9.3|=0.446
91705167|NCT05153148|183304895|SUPERIORITY||Risk Difference (RD)|24.1|||=|0.002|TWO_SIDED|95.0|8.6|39.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.6|8.6|=0.002
91705168|NCT05153148|183304895|SUPERIORITY||Risk Difference (RD)|24.5|||=|0.002|TWO_SIDED|95.0|9.0|39.9|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.9|9.0|=0.002
91705169|NCT05153148|183304896|SUPERIORITY||Risk Difference (RD)|5.7|||=|0.312|TWO_SIDED|95.0|-5.3|16.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|16.6|-5.3|=0.312
91705170|NCT05153148|183304896|SUPERIORITY||Risk Difference (RD)|17.0|||=|0.005|TWO_SIDED|95.0|5.0|29.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.1|5.0|=0.005
91705171|NCT05153148|183304896|SUPERIORITY||Risk Difference (RD)|16.4|||=|0.009|TWO_SIDED|95.0|4.2|28.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.6|4.2|=0.009
91705172|NCT05153148|183304897|SUPERIORITY||Risk Difference (RD)|2.9|||=|0.532|TWO_SIDED|95.0|-6.6|12.7|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||12.7|-6.6|=0.532
91705173|NCT05153148|183304897|SUPERIORITY||Risk Difference (RD)|9.1|||=|0.101|TWO_SIDED|95.0|-1.0|20.1|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||20.1|-1.0|=0.101
91705174|NCT05153148|183304897|SUPERIORITY||Risk Difference (RD)|8.3|||=|0.158|TWO_SIDED|95.0|-1.7|19.4|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||19.4|-1.7|=0.158
91499234|NCT02622321|182868135|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11||||0.005|TWO_SIDED|95.0|0.025|0.52||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.520|0.025|0.0050
91499235|NCT02622321|182868136|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.119|0.435||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.435|0.119|<0.0001
91499236|NCT02622321|182868137|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.21||||0.0003|TWO_SIDED|95.0|0.089|0.486||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.486|0.089|0.0003
91499237|NCT02622321|182868138|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.037|0.154||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.154|0.037|<0.0001
91499238|NCT02622321|182868139|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.05||||0.0002|TWO_SIDED|95.0|0.009|0.227||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.227|0.009|0.0002
91499239|NCT02622321|182868143|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|21.55||||0.0029|TWO_SIDED|95.0|7.89|35.22||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm. Analysis was performed using Analysis of Covariance (ANCOVA).||35.22|7.89|0.0029
91499240|NCT02622321|182868144|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|14.01||||0.0019|TWO_SIDED|95.0|5.56|22.45||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||22.45|5.56|0.0019
91499241|NCT02622321|182868145|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.72||||0.0171|TWO_SIDED|95.0|-17.62|-1.82||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-1.82|-17.62|0.0171
91499242|NCT02622321|182868146|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.16||||0.0014|TWO_SIDED|95.0|-0.25|-0.07||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-0.07|-0.25|0.0014
91499243|NCT01958008|182868163|SUPERIORITY_OR_OTHER||Slope|1.2674|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|1.0636|1.4713|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint Cmax,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.4713|1.0636|
91499244|NCT01958008|182868164|SUPERIORITY_OR_OTHER||Slope|1.2139|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|1.0519|1.3759|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint AUC tau,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.3759|1.0519|
91499245|NCT03194698|182868183|SUPERIORITY|||||||0.0312|||||||Wilcoxon (Mann-Whitney)|||||||0.0312
91499246|NCT03194698|182868184|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91531081|NCT03850444|182938507|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.41|0.95|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.95|0.41|
91499247|NCT03194698|182868185|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
91499248|NCT00710710|182868230|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
91499249|NCT00710710|182868230|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
91499250|NCT00710710|182868230|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
91499251|NCT00710710|182868230|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
91499252|NCT00710710|182868233|OTHER||Hazard Ratio (HR)|1.22||||0.38|TWO_SIDED|95.0|0.78|1.91|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.91|0.78|0.38
91499253|NCT00710710|182868234|OTHER||Hazard Ratio (HR)|1.1||||0.69|TWO_SIDED|95.0|0.68|1.78|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.78|0.68|0.69
91499254|NCT00710710|182868235|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
91499255|NCT00710710|182868235|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
91499256|NCT00710710|182868235|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
91705175|NCT05153148|183304898|SUPERIORITY||Treatment Difference|-1.7|||=|0.268|TWO_SIDED|95.0|-4.8|1.3|||Mixed Model Repeated Measure (MMRM)||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-4.8|=0.268
91705176|NCT05153148|183304898|SUPERIORITY||Treatment Difference|-3.0|||=|0.051|TWO_SIDED|95.0|-6.1|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-6.1|=0.051
91705177|NCT05153148|183304898|SUPERIORITY||Treatment Difference|-2.5|||=|0.112|TWO_SIDED|95.0|-5.6|0.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.6|-5.6|=0.112
91705178|NCT05153148|183304899|SUPERIORITY||Treatment Difference|-0.9|||=|0.28|TWO_SIDED|95.0|-2.4|0.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.7|-2.4|=0.280
91705179|NCT05153148|183304899|SUPERIORITY||Treatment Difference|-1.1|||=|0.177|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.177
91705180|NCT05153148|183304899|SUPERIORITY||Treatment Difference|-1.0|||=|0.196|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.196
91705181|NCT05153148|183304900|SUPERIORITY||Treatment Difference|-1.9|||=|0.637|TWO_SIDED|95.0|-9.6|5.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|5.9|-9.6|=0.637
91705182|NCT05153148|183304900|SUPERIORITY||Treatment Difference|-9.2|||=|0.021|TWO_SIDED|95.0|-17.0|-1.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.4|-17.0|=0.021
91499257|NCT00710710|182868235|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
91499258|NCT00715078|182868242|NON_INFERIORITY_OR_EQUIVALENCE|Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|ratio of geometric means (GeoMean)|1.046||||0.5019|TWO_SIDED|90.0|0.936|1.168|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.168|0.936|0.5019
91705183|NCT05153148|183304900|SUPERIORITY||Treatment Difference|-8.7|||=|0.03|TWO_SIDED|95.0|-16.5|-0.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-0.9|-16.5|=0.030
91705184|NCT05153148|183304901|SUPERIORITY||Treatment Difference|-0.9|||=|0.812|TWO_SIDED|95.0|-8.4|6.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|6.6|-8.4|=0.812
91499259|NCT00715078|182868242|NON_INFERIORITY_OR_EQUIVALENCE|Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|the ratio of geometric means|0.907||||0.1443|TWO_SIDED|90.0|0.813|1.013|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.013|0.813|0.1443
91499260|NCT01529346|182868245|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.22||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.22|-0.38|
91531082|NCT03850444|182938508|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.94|0.45|
91705185|NCT05153148|183304901|SUPERIORITY||Treatment Difference|-6.7|||=|0.079|TWO_SIDED|95.0|-14.2|0.8|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.8|-14.2|=0.079
91705186|NCT05153148|183304901|SUPERIORITY||Treatment Difference|-6.3|||=|0.102|TWO_SIDED|95.0|-13.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-13.9|=0.102
91705187|NCT05153148|183304902|SUPERIORITY||Treatment Difference|-8.9|||=|0.016|TWO_SIDED|95.0|-16.2|-1.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.7|-16.2|=0.016
91739112|NCT02722408|183370299|OTHER|||||||0.3657||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3657
91739113|NCT02722408|183370299|OTHER|||||||0.1983||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1983
91739114|NCT02722408|183370299|OTHER|||||||0.297||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2970
91739115|NCT02722408|183370299|OTHER|||||||0.0092||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0092
91739116|NCT02722408|183370299|OTHER|||||||0.0049||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0049
91499261|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.39|-0.20|
91739117|NCT02722408|183370299|OTHER|||||||0.0033||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0033
91739118|NCT02722408|183370299|OTHER|||||||0.0618||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0618
91739119|NCT02722408|183370299|OTHER|||||||0.0298||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0298
91531083|NCT03850444|182938509|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.57|1.28|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.28|0.57|
91705188|NCT05153148|183304902|SUPERIORITY||Treatment Difference|-10.6|||=|0.004|TWO_SIDED|95.0|-17.8|-3.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.4|-17.8|=0.004
91739120|NCT02722408|183370299|OTHER|||||||0.0352||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0352
91739121|NCT02722408|183370299|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
91739122|NCT02722408|183370299|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
91739123|NCT02722408|183370299|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
91739124|NCT02722408|183370300|OTHER|||||||0.3672||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr||||0.3672
91739125|NCT02722408|183370300|OTHER|||||||0.2101||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2101
91739126|NCT02722408|183370300|OTHER|||||||0.3009||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.3009
91739127|NCT02722408|183370300|OTHER|||||||0.1567||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1567
91739128|NCT02722408|183370300|OTHER|||||||0.1207||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.1207
91499262|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.28|0.32||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.32|-0.28|
91499263|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.41|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.41|
91739129|NCT02722408|183370300|OTHER|||||||0.1045||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.1045
91739130|NCT02722408|183370300|OTHER|||||||0.0631||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0631
91739131|NCT02722408|183370300|OTHER|||||||0.0217||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0217
91739132|NCT02722408|183370300|OTHER|||||||0.0359||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0359
91739133|NCT02722408|183370300|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
91739134|NCT02722408|183370300|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
91739135|NCT02722408|183370300|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
91739136|NCT02722408|183370301|OTHER|||||||0.9417||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9417
91739137|NCT02722408|183370301|OTHER|||||||0.7722||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7722
91739138|NCT02722408|183370301|OTHER|||||||0.5283||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5283
91739139|NCT02722408|183370301|OTHER|||||||0.5905||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5905
91739140|NCT02722408|183370301|OTHER|||||||0.7682||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7682
91499264|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.44||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.32|
91499265|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.01|0.77||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.01|
91739141|NCT02722408|183370301|OTHER|||||||0.9245||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9245
91739142|NCT02722408|183370301|OTHER|||||||0.6325||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.6325
91739143|NCT02722408|183370301|OTHER|||||||0.9221||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9221
91739144|NCT02722408|183370301|OTHER|||||||0.8387||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8387
91739145|NCT02722408|183370301|OTHER|||||||0.0089||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0089
91739146|NCT02722408|183370301|OTHER|||||||0.0013||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0013
91739147|NCT02722408|183370301|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0019
91739148|NCT02722408|183370302|OTHER|||||||0.9195||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9195
91739149|NCT02722408|183370302|OTHER|||||||0.7497||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7497
91739150|NCT02722408|183370302|OTHER|||||||0.5056||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5056
91739151|NCT02722408|183370302|OTHER|||||||0.2468||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2468
91739152|NCT02722408|183370302|OTHER|||||||0.392||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3920
91739153|NCT02722408|183370302|OTHER|||||||0.4456||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4456
91739154|NCT02722408|183370302|OTHER|||||||0.9203||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9203
91739155|NCT02722408|183370302|OTHER|||||||0.9704||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9704
91739156|NCT02722408|183370302|OTHER|||||||0.9755||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9755
91739157|NCT02722408|183370302|OTHER|||||||0.4213||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4213
91531084|NCT03850444|182938510|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.39|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.39|0.70|
91739158|NCT02722408|183370302|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
91739159|NCT02722408|183370302|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
91739160|NCT02722408|183370308|OTHER|||||||0.0294||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0294
91739161|NCT02722408|183370308|OTHER|||||||0.3228||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3228
91499266|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.22|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|-0.22|
91499267|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.24|1.07||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.07|0.24|
91499268|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.37|0.42||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.42|-0.37|
91499269|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.0|0.78||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.78|-0.00|
91531085|NCT03850444|182938511|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.74|1.35|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.35|0.74|
91531086|NCT03850444|182938512|OTHER||Difference in Percentage (DP)|17.2|||||TWO_SIDED|95.0|1.8|31.6|||Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||31.6|1.8|
91739162|NCT02722408|183370308|OTHER|||||||0.5268||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5268
91739163|NCT02722408|183370309|OTHER|||||||0.1099||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1099
91739164|NCT02722408|183370309|OTHER|||||||0.5478||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5478
91739165|NCT02722408|183370309|OTHER|||||||0.8837||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8837
91739166|NCT02722408|183370310|OTHER|||||||0.0587||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0587
91739167|NCT02722408|183370310|OTHER|||||||0.1491||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.1491
91739168|NCT02722408|183370310|OTHER|||||||0.2224||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2224
91739169|NCT02722408|183370311|OTHER|||||||0.0959||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0959
91739170|NCT02722408|183370311|OTHER|||||||0.0923||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0923
91739171|NCT02722408|183370311|OTHER|||||||0.1592||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.1592
91739172|NCT02722408|183370312|OTHER|||||||0.5856||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.5856
91739173|NCT02722408|183370312|OTHER|||||||0.644||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6440
91739174|NCT02722408|183370312|OTHER|||||||0.2269||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2269
91739175|NCT02722408|183370313|OTHER|||||||0.4814||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4814
91739176|NCT02722408|183370313|OTHER|||||||0.5011||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5011
91499270|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.29|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.29|
91739177|NCT02722408|183370313|OTHER|||||||0.4356||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.4356
91739178|NCT02722408|183370314|OTHER|||||||0.0669||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0669
91739179|NCT02722408|183370314|OTHER|||||||0.0189||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0189
91739180|NCT02722408|183370314|OTHER|||||||0.0316||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0316
91739181|NCT02722408|183370315|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0685
91739182|NCT02722408|183370315|OTHER|||||||0.0114||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0114
91739183|NCT02722408|183370315|OTHER|||||||0.0263||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0263
91739184|NCT02722408|183370316|OTHER|||||||0.1466||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1466
91739185|NCT02722408|183370316|OTHER|||||||0.3598||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3598
91739186|NCT02722408|183370316|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0685
91739187|NCT02722408|183370317|OTHER|||||||0.166||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1660
91739188|NCT02722408|183370317|OTHER|||||||0.3423||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3423
91499271|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.59|1.45||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.45|0.59|
91499272|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.21|0.62||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.21|
91739189|NCT02722408|183370317|OTHER|||||||0.0313||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0313
91739190|NCT02722408|183370318|OTHER|||||||0.7196||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7196
91739191|NCT02722408|183370318|OTHER|||||||0.4343||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4343
91739192|NCT02722408|183370318|OTHER|||||||0.7241||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.7241
91739193|NCT02722408|183370319|OTHER|||||||0.7952||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7952
91739194|NCT02722408|183370319|OTHER|||||||0.4931||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4931
91499273|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.07|0.76||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|-0.07|
91739195|NCT02722408|183370319|OTHER|||||||0.8622||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8622
91739196|NCT02722408|183370320|OTHER|||||||0.9823||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.9823
91739197|NCT02722408|183370320|OTHER|||||||0.9129||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.9129
91739198|NCT02722408|183370320|OTHER|||||||0.7762||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.7762
91739199|NCT02722408|183370321|OTHER|||||||0.2683||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2683
91739200|NCT02722408|183370321|OTHER|||||||0.088||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0880
91739201|NCT02722408|183370321|OTHER|||||||0.0165||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0165
91739202|NCT02722408|183370322|OTHER|||||||0.4585||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4585
91739203|NCT02722408|183370322|OTHER|||||||0.3721||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3721
91739204|NCT02722408|183370322|OTHER|||||||0.5305||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5305
91739205|NCT02722408|183370323|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2937
91739206|NCT02722408|183370323|OTHER|||||||0.2182||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.2182
91499274|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.11|0.72||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.11|
91739207|NCT02722408|183370323|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2937
91739208|NCT02722408|183370324|OTHER|||||||0.0411||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0411
91739209|NCT02722408|183370324|OTHER|||||||0.0192||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0192
91739210|NCT02722408|183370324|OTHER|||||||0.0445||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0445
91739211|NCT02722408|183370325|OTHER|||||||0.0465||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0465
91739212|NCT02722408|183370325|OTHER|||||||0.0221||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0221
91739213|NCT02722408|183370325|OTHER|||||||0.0402||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0402
91739214|NCT00552071|183370326|OTHER|||||||0.4||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.40
91739215|NCT00552071|183370327|OTHER|||||||0.43||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.43
91739216|NCT00272792|183370328|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||<0.001
91739217|NCT00272792|183370328|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||0.027
91739218|NCT00272792|183370329|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Longitudinal Model|Longitudinal model with blood Phe measurements as the response variable and treatment group, visit, and baseline blood Phe level as covariates.||||||0.009
91739219|NCT00298389|183370352|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
91739220|NCT00298389|183370353|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
91739221|NCT02628444|183370354|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (Group 2/Group 1) was greater than (\>) 1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.862|1.39||||||Group 2/Group 1: Serotype 1||1.39|0.862|
91739222|NCT02628444|183370354|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.993|||||TWO_SIDED|95.0|0.82|1.2||||||Group 2/Group 1: Serotype 2||1.20|0.820|
91739223|NCT02628444|183370354|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.983|||||TWO_SIDED|95.0|0.816|1.18||||||Group 2/Group 1: Serotype 3||1.18|0.816|
91739224|NCT02628444|183370354|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.809|1.14||||||Group 2/Group 1: Serotype 4||1.14|0.809|
91739225|NCT02628444|183370355|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.757|1.4||||||Group 2/Group 1: Serotype 1||1.40|0.757|
91739226|NCT02628444|183370355|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.897|||||TWO_SIDED|95.0|0.705|1.14||||||Group 2/Group 1: Serotype 2||1.14|0.705|
91499275|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|0.85|1.75||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.75|0.85|
91739227|NCT02628444|183370355|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group 2/Group 1: Serotype 3||1.16|0.724|
91531087|NCT03850444|182938513|OTHER||Difference in Percentage (DP)|11.3|||||TWO_SIDED|95.0|-1.4|23.7|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||23.7|-1.4|
91739228|NCT02628444|183370355|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.884|||||TWO_SIDED|95.0|0.72|1.09||||||Group 2/Group 1: Serotype 4||1.09|0.720|
91739229|NCT02628444|183370356|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.567|||||TWO_SIDED|98.75|0.399|0.805||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 1||0.805|0.399|
91739230|NCT02628444|183370356|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.746|||||TWO_SIDED|98.75|0.55|1.01||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 2||1.01|0.550|
91739231|NCT02628444|183370356|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.04|||||TWO_SIDED|98.75|0.686|1.57||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 3||1.57|0.686|
91739232|NCT02628444|183370356|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.647|||||TWO_SIDED|98.75|0.434|0.963||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 4||0.963|0.434|
91739233|NCT02628444|183370357|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.627|||||TWO_SIDED|98.75|0.342|1.15||||||Group 2a Booster dose/Group 1 Post-dose 3: Serotype 1||1.15|0.342|
91739234|NCT02628444|183370357|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.809|||||TWO_SIDED|98.75|0.505|1.3||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 2||1.30|0.505|
91739235|NCT02628444|183370357|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.19|||||TWO_SIDED|98.75|0.732|1.94||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 3||1.94|0.732|
91739236|NCT02628444|183370357|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.499|||||TWO_SIDED|98.75|0.331|0.754||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 4||0.754|0.331|
91739237|NCT02628444|183370358|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.688|||||TWO_SIDED|98.75|0.479|0.989||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 1||0.989|0.479|
91739238|NCT02628444|183370358|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.871|||||TWO_SIDED|98.75|0.673|1.13||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 2||1.13|0.673|
91739239|NCT02628444|183370358|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.15|||||TWO_SIDED|98.75|0.887|1.49||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 3||1.49|0.887|
91739240|NCT02628444|183370358|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.655|||||TWO_SIDED|98.75|0.471|0.911||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 4||0.911|0.471|
91499276|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.04|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.04|
91739241|NCT02628444|183370359|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.889|||||TWO_SIDED|98.75|0.462|1.71||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 1||1.71|0.462|
91739242|NCT02628444|183370359|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.677|||||TWO_SIDED|98.75|0.402|1.14||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 2||1.14|0.402|
91739243|NCT02628444|183370359|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.911|||||TWO_SIDED|98.75|0.573|1.45||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 3||1.45|0.573|
91739244|NCT02628444|183370359|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.702|||||TWO_SIDED|98.75|0.447|1.1||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 4||1.10|0.447|
91739245|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.833|1.33||||||Group2/Group1: Serotype 1 (28 days after last vaccination)||1.33|0.833|
91739246|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.821|1.19||||||Group2/Group1: Serotype 2 (28 days after last vaccination)||1.19|0.821|
91739247|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.972|||||TWO_SIDED|95.0|0.81|1.17||||||Group2/Group1: Serotype 3 (28 days after last vaccination)||1.17|0.810|
91739248|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.963|||||TWO_SIDED|95.0|0.814|1.14||||||Group2/Group1: Serotype 4 (28 days after last vaccination)||1.14|0.814|
91739249|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.762|1.39||||||Group2/Group1: Serotype 1 (1 year after last vaccination)||1.39|0.762|
91739250|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group2/Group1: Serotype 2 (1 year after last vaccination)||1.16|0.724|
91739251|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.933|||||TWO_SIDED|95.0|0.742|1.17||||||Group2/Group1: Serotype 3 (1 year after last vaccination)||1.17|0.742|
91739252|NCT02628444|183370360|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.916|||||TWO_SIDED|95.0|0.75|1.12||||||Group2/Group1: Serotype 4 (1 year after last vaccination)||1.12|0.750|
91739253|NCT00288015|183370378|OTHER|This is a two-stage optimal simon design. If bevacizumab is not effective, there is a 0.050 probability of concluding that it is. If bevacizumab is effective, there is a 0.2000 probability of concluding that it is not.||||||||||||In first stage 12 patients will be entered, if \</=3 patients have PFS time\>3 months p\</=0.22 is likely true. In second stage a total of up to 31 patients data will be analysed. If \>/=10 patients show PFS\</=3 months, it will suggest p\>0.50 is true.|Kaplan-Meier estimate|||This is a two stage optimal simon design testing the Null hypothesis: bevacizumab is not effective with P\<=0.220 and the alternative hypothesis: bevacizumab is effective with P \>=0.450 and has a sample size of 16.96 and a probability of early termination of 0.739. p=probability (progression free survival - PFS time\>/=3 months).|P\<=0.220 is the threshold value of significance that the null hypothesis is true or the alternative hypothesis is true. P Value was not calculated from the data. Median survival time was calculated using a 20% censored Kaplan-Meier table and graph.|||
91739254|NCT02079909|183370430|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.3919|TWO_SIDED||||||Mixed Models Analysis|||||||0.3919
91739255|NCT02079909|183370431|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7588|TWO_SIDED||||||Mixed Models Analysis|||||||0.7588
91739256|NCT02079909|183370432|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.3212|TWO_SIDED||||||Mixed Models Analysis|||||||0.3212
91739257|NCT02277249|183370433|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.||||0.36
91739258|NCT01869634|183370451|OTHER|Wilcoxon signed-rank test. Paired samples.||||||0.0025|||||||Sign test|||Comparison between HIV positive naïve to ART before and after ART has been done.||||0.0025
91739259|NCT01869634|183370452|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91739260|NCT01869634|183370452|OTHER|Wilcoxon signed-rank test||||||0.826|||||||Sign test|||Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.||||0.826
91739261|NCT01869634|183370453|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||comparison between groups (HIV+ vs HIV-)||||<0.001
91739262|NCT01869634|183370453|OTHER|||||||0.807|||||||Sign test|||Changes in systemic immune activation through IL6||||0.807
91739263|NCT02098304|183370486|SUPERIORITY_OR_OTHER||Percentage agreement|72.3|||<|0.001|TWO_SIDED|95.0|59.8|82.7|||Exact binomial test|An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.||The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.||82.7|59.8|<0.001
91739264|NCT02098304|183370486|SUPERIORITY_OR_OTHER||Cohen's kappa|0.45||||0.001|TWO_SIDED|95.0|0.24|0.66|||Cohen's Kappa||Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.|The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen's kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.||0.66|0.24|0.001
91739265|NCT00457392|183370490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.1933|TWO_SIDED|95.0|0.822|1.079||p-value was not adjusted for multiple comparisons.|Log Rank|||Differences in OS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and epidermal growth factor receptor (EGFR) status (positive, versus negative, versus unknown).||1.079|0.822|0.1933
91739266|NCT00457392|183370491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807||||0.0023|TWO_SIDED|95.0|0.695|0.937||No p-value is adjusted for multiple comparisons for PFS.|Log Rank|One-sided log-rank test with alpha=0.025 was used.||Differences in PFS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown).||0.937|0.695|0.0023
91531088|NCT03850444|182938514|OTHER||Difference in Percentage (DP)|8.0|||||TWO_SIDED|95.0|-3.0|18.9|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||18.9|-3.0|
91739267|NCT00457392|183370492|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.514||||0.0471|TWO_SIDED|95.0|1.002|2.289|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown) was used to compare ORR between the 2 treatment arms. The relative risk ratio estimator was used to contrast the treatment effects on response rates. A point estimate of relative risk ratio and 2-sided 95% CI was calculated.||2.289|1.002|0.0471
91739268|NCT00756275|183370496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33|||<|0.05|TWO_SIDED|95.0|0.91|20.56|||Chi-squared|||||20.56|.91|<0.05
91739269|NCT00756275|183370497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.36||0.5|TWO_SIDED|95.0|-6.29|3.11|||t-test, 2 sided|||||3.11|-6.29|.50
91739270|NCT00756275|183370498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3|TWO_SIDED|95.0|0.58|14.5|||Fisher Exact|||||14.50|.58|.30
91739271|NCT00756275|183370499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.98|STANDARD_ERROR_OF_MEAN|8.38||0.34|TWO_SIDED|95.0|-24.64|8.68|||t-test, 2 sided|||||8.68|-24.64|.34
91739272|NCT00756275|183370500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39|STANDARD_ERROR_OF_MEAN|8.1||0.36|TWO_SIDED|95.0|-8.73|23.52|||t-test, 2 sided|||||23.52|-8.73|.36
91739273|NCT00756275|183370501|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||||||.57
91739274|NCT00756275|183370502|SUPERIORITY_OR_OTHER|||||||0.31|||||||Chi-squared|||||||.31
91739275|NCT00756275|183370503|SUPERIORITY_OR_OTHER|||||||0.72|||||||Chi-squared|||||||.72
91739276|NCT00756275|183370504|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||||||.18
91739277|NCT00756275|183370505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.72||0.75|TWO_SIDED|95.0|-3.98|2.87|||t-test, 2 sided|||||2.87|-3.98|.75
91499277|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.1|0.75||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.75|-0.10|
91499278|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.05|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.05|
91499279|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|1.22|2.15||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.15|1.22|
91531089|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4||||||Unmasked minus masked||1.4|-2.2|
91531090|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||Unmasked minus masked||2.5|-1.5|
91531091|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.1|2.2||||||Unmasked minus masked||2.2|-0.1|
91499280|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.01|0.99||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.99|0.01|
91499281|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.05|1.03||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.05|
91499282|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.04|0.94||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.04|
91499283|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.26|2.31||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.31|1.26|
91531092|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|0.2|3.5||||||Unmasked minus masked||3.5|0.2|
91531093|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.3|1.2||||||Partial masked minus masked||1.2|-3.3|
91499284|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.06|1.11||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.06|
91531094|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.9|1.1||||||Partial masked minus masked||1.1|-1.9|
91739278|NCT00980148|183370506|NON_INFERIORITY_OR_EQUIVALENCE|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.|Risk Difference (RD)|3.2|||||ONE_SIDED|90.0||5.9|||||The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.||5.9||
91739279|NCT01244035|183370557|OTHER||LS Mean difference|1.1||||0.1325|TWO_SIDED|90.0|-0.54|2.74|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.74|-0.54|0.1325
91739280|NCT01244035|183370557|OTHER||LS Mean difference|4.16|||<|0.001|TWO_SIDED|90.0|2.53|5.79|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||5.79|2.53|<0.001
91739281|NCT01244035|183370557|OTHER||LS Mean difference|-3.06||||0.0016|TWO_SIDED|90.0|-4.7|-1.42|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-1.42|-4.70|0.0016
91739282|NCT01244035|183370558|OTHER||LS Mean difference|-2.94||||0.0212|TWO_SIDED|90.0|-5.3|-0.57|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.57|-5.30|0.0212
91739283|NCT01244035|183370558|OTHER||LS Mean difference|-2.76||||0.0299|TWO_SIDED|90.0|-5.16|-0.36|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.36|-5.16|0.0299
91739284|NCT01244035|183370558|OTHER||LS Mean difference|-0.18||||0.4506|TWO_SIDED|90.0|-2.54|2.19|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.19|-2.54|0.4506
91739285|NCT00696878|183370642|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.4|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.4||
91739286|NCT00696878|183370642|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.8|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.8||
91739287|NCT00696878|183370642|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||1.5|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||1.5||
91531095|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Partial masked minus masked||2.7|-2.9|
91531096|NCT01155726|182938537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-1.1|1.9||||||Partial masked minus masked||1.9|-1.1|
91739288|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|2.11||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR4521||||0.010
91739289|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|0.56||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR107||||0.010
91739290|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|2.57||||0.018|TWO_SIDED||||||t-test, 2 sided|||miR-891a||||0.018
91739291|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|0.88||||0.021|TWO_SIDED||||||t-test, 2 sided|||miR363||||0.021
91739292|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-1.0||||0.028|TWO_SIDED||||||t-test, 2 sided|||miR1248||||0.028
91739293|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-0.85||||0.033|TWO_SIDED||||||t-test, 2 sided|||miR944||||0.033
91739294|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|2.13||||0.034|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.034
91531097|NCT02054247|182938538|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
91531098|NCT02054247|182938539|SUPERIORITY|||||||0.083|||||||ANOVA|||||||0.083
91531099|NCT02054247|182938540|SUPERIORITY|||||||0.125|||||||ANOVA|||||||0.125
91531100|NCT02054247|182938541|SUPERIORITY|||||||0.146|||||||ANOVA|||||||0.146
91531101|NCT05257837|182938543|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91531102|NCT05257837|182938544|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91739295|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|0.39||||0.036|TWO_SIDED||||||t-test, 2 sided|||miR103a||||0.036
91739296|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|1.69||||0.037|TWO_SIDED||||||t-test, 2 sided|||miR454||||0.037
91739297|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-1.13||||0.041|TWO_SIDED||||||t-test, 2 sided|||miR320e||||0.041
91739298|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-0.55||||0.043|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.043
91739299|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|1.95||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR130b||||0.044
91739300|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-2.18||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR365a||||0.044
91739301|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|2.06||||0.047|TWO_SIDED||||||t-test, 2 sided|||miR135b||||0.047
91739302|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-2.35||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR1273h||||0.048
91739303|NCT02230189|183370725|SUPERIORITY||Mean Difference (Net)|-1.31||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR3177||||0.048
91739304|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-1.83||||0|TWO_SIDED||||||t-test, 2 sided|||miR6510||||0.0
91739305|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-2.09||||0|TWO_SIDED||||||t-test, 2 sided|||miR3605||||0
91739306|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-5.75||||0|TWO_SIDED||||||t-test, 2 sided|||miR3912||||0
91739307|NCT02230189|183370726|SUPERIORITY||Median Difference (Net)|1.93||||0|TWO_SIDED||||||t-test, 2 sided|||miR15b||||0
91739308|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-2.35||||0|TWO_SIDED||||||t-test, 2 sided|||miR127||||0
91739309|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.59||||0|TWO_SIDED||||||t-test, 2 sided|||miR146a||||0
91739310|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.21||||0|TWO_SIDED||||||t-test, 2 sided|||miR449b||||0
91739311|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|0.85||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21-5p||||0.01
91739312|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-1.29||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6842||||0.01
91739313|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR142-5p||||0.01
91499285|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.17||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.17|0.11|
91739314|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.67||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21||||0.01
91739315|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-4.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR493||||0.01
91739316|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-1.46||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR193a||||0.01
91739317|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.89||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR149||||0.01
91739318|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.06||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR449a||||0.01
91739319|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-2.1||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6511a||||0.01
91739320|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-1.59||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6843||||0.01
91739321|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.95||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR671||||0.01
91739322|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-4.65||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6503||||0.02
91739323|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|2.84||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR450b||||0.02
91739324|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-4.92||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR485||||0.02
91739325|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-2.49||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.02
91739326|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|2.18||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3182||||0.02
91739327|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.28||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR142-3p||||0.02
91739328|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-1.23||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR320d||||0.02
91739329|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|2.73||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3928||||0.02
91739330|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|4.59||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR744||||0.02
91739331|NCT02230189|183370726|SUPERIORITY||Median Difference (Net)|3.42||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR206||||0.02
91739332|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|0.9||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR30e||||0.03
91739333|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR4500||||0.03
91739334|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.98||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR125a||||0.03
91739335|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.6||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR99b||||0.03
91739336|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|2.67||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1||||0.03
91739337|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.77||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.03
91739338|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-3.17||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1255a||||0.03
91739339|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.02||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR223||||0.03
91739340|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.78||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR642a||||0.03
91739341|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|2.17||||0.4|TWO_SIDED||||||t-test, 2 sided|||miR548ae||||0.4
91739342|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.79||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.04
91739343|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-2.52||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR877||||0.04
91739344|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-0.69||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.04
91739345|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-3.4||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR4467||||0.04
91739346|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-2.48||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR1249||||0.04
91739347|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|3.87||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR766||||0.04
91739348|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|1.07||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR29c||||0.048
91739349|NCT02230189|183370726|SUPERIORITY||Mean Difference (Net)|-1.75||||-1.75|TWO_SIDED||||||t-test, 2 sided|||miR370||||-1.75
91739350|NCT05501639|183370732|OTHER|||||||0.758|||||||Log Rank|||||||0.758
91739351|NCT05501639|183370733|OTHER|||||||0.474|||||||Log Rank|||||||0.474
91739352|NCT05501639|183370734|OTHER|||||||0.472|||||||Chi-squared|||||||0.472
91739353|NCT05501639|183370735|OTHER||Incidence rate ratio|0.647|||||TWO_SIDED|95.0|0.261|1.604|||||Incidence rate ratio at 6 months|||1.604|0.261|
91499286|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.15||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.15|0.11|
91499287|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.33|2.4||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.40|1.33|
91499288|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.07|1.05||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.05|-0.07|
91499289|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.24|0.91||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.24|
91499290|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.13|0.98||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.98|-0.13|
91499291|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|1.05|2.17||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.17|1.05|
91499292|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.74|0.64||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|-0.74|
91499293|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.86|0.56||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.56|-0.86|
91739354|NCT05501639|183370735|OTHER||Incidence rate ratio|1.005|||||TWO_SIDED|95.0|0.513|1.969|||||Incidence rate ratio at 12 months|||1.969|0.513|
91499294|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.57|0.8||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.57|
91499295|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|0.22|1.58||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.58|0.22|
91499296|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.93|0.59||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.59|-0.93|
91499297|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.98|0.62||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.98|
91499298|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.05|0.45||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-1.05|
91531103|NCT05257837|182938545|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||.012
91739355|NCT05501639|183370736|OTHER|||||||0.222|||||||Chi-squared|||Hospitalisations||||0.222
91739356|NCT05501639|183370736|OTHER|||||||0.553|||||||Chi-squared|||Asthma-related hospitalisations||||0.553
91739357|NCT05501639|183370736|OTHER|||||||0.192|||||||Chi-squared|||ED visits||||0.192
91739358|NCT05501639|183370736|OTHER|||||||0.383|||||||Chi-squared|||Asthma-related ED visits||||0.383
91739359|NCT05501639|183370736|OTHER|||||||0.338|||||||Chi-squared|||OP visits||||0.338
91739360|NCT05501639|183370736|OTHER||||||<|0.0001|||||||Chi-squared|||Asthma-related OP visits||||<0.0001
91739361|NCT05501639|183370737|OTHER|||||||0.538|||||||t-test, 2 sided|||Hospitalisations||||0.538
91499299|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-0.47|1.02||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.02|-0.47|
91499300|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.15|1.11||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.15|
91499301|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.74||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.74|-0.27|
91499302|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.03|
91499303|NCT01529346|182868245|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.3|0.67||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.67|-0.30|
91531104|NCT05257837|182938547|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||.217
91739362|NCT05501639|183370737|OTHER|||||||0.913|||||||t-test, 2 sided|||Asthma-related hospitalisations||||0.913
91739363|NCT05501639|183370737|OTHER|||||||0.688|||||||t-test, 2 sided|||ED visits||||0.688
91739364|NCT05501639|183370737|OTHER|||||||0.892|||||||t-test, 2 sided|||Asthma-related ED visits||||0.892
91739365|NCT05501639|183370737|OTHER||||||<|0.0001|||||||t-test, 2 sided|||OP visits||||<0.0001
91739366|NCT05501639|183370737|OTHER|||||||0.002|||||||t-test, 2 sided|||Asthma-related OP visits||||0.002
91739367|NCT05501639|183370738|OTHER|||||||0.378|||||||Chi-squared|||||||0.378
91739368|NCT03188263|183370739|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.046||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.046
91739369|NCT03188263|183370740|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.35||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.35
91739370|NCT04021290|183370799|NON_INFERIORITY|Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC - CAR) is less than 5%.|Adjusted Difference in Percent (ADP)|-0.8|||||TWO_SIDED|95.0|-2.4|0.8|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.8|-2.4|
91739371|NCT04021290|183370800|NON_INFERIORITY|Non-inferiority will be concluded if the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms (DTG/3TC-CAR) is greater than -12%.|Adjusted Difference in Percent|1.6|||||TWO_SIDED|95.0|-2.8|5.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (PI, NNRTI, and INI).|||5.9|-2.8|
91739372|NCT04021290|183370821|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
91739373|NCT04021290|183370822|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
91739374|NCT04021290|183370823|OTHER||Adjusted Mean|-1.6||||0.021|TWO_SIDED|95.0|-2.9|-0.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||-0.2|-2.9|0.021
91739375|NCT04021290|183370824|OTHER||Adjusted Mean|-0.5||||0.398|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||0.7|-1.8|0.398
91739376|NCT03391882|183370826|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|1.722||0.8944|TWO_SIDED|95.0|-3.16|3.62|||Mixed Models Analysis|||||3.62|-3.16|0.8944
91739377|NCT03391882|183370827|SUPERIORITY||Odds Ratio (OR)|1.129||||0.7777|TWO_SIDED|95.0|0.484|2.637|||generalized linear random effects model|||||2.637|0.484|0.7777
91739378|NCT03391882|183370828|SUPERIORITY|||||||0.0002|TWO_SIDED|||||The p-value is from a 1-sample, 2-sided test of the null hypothesis that the true proportion preferring APL is 50% to evaluate if a significantly higher proportion of the subjects prefer APL-130277 or not.|binomial distribution with normal approx|||||||0.0002
91739379|NCT03391882|183370829|SUPERIORITY||Odds Ratio (OR)|1.835||||0.1769|TWO_SIDED|95.0|0.759|4.438|||generalized linear random effects model|||||4.438|0.759|0.1769
91739380|NCT03391882|183370830|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3922|TWO_SIDED|95.0|0.61|3.53|||generalized linear random effects model|||||3.53|0.61|0.3922
91739381|NCT04683913|183370831|OTHER||||||<|0.001|||||||ANCOVA|alpha=0.05||||||<0.001
91499304|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.19|0.14||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.14|-0.19|
91499305|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.03|0.37||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.37|0.03|
91739382|NCT04683913|183370832|OTHER|||||||0.027||||||Week 1\&2 vs Week 3\&4|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.027
91739383|NCT04683913|183370832|OTHER|||||||1||||||Week 3\&4 vs Week 5\&6|t-test, 2 sided|||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
91739384|NCT04683913|183370832|OTHER|||||||0.078||||||Week 5\&6 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.078
91739385|NCT04683913|183370832|OTHER|||||||0.015||||||Follow up vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.015
91739386|NCT04683913|183370832|OTHER|||||||0.567||||||Week 1\&2 vs Week 5\&6|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.567
91739387|NCT04683913|183370832|OTHER|||||||0.001||||||Week 1\&2 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.001
91739388|NCT04683913|183370832|OTHER|||||||1||||||Week 1\&2 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
91531105|NCT05257837|182938548|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||.745
91531106|NCT05675709|182938552|SUPERIORITY|paired t-test||||||0.05|||||||paired t-test|||||||0.05
91739389|NCT04683913|183370832|OTHER|||||||0.205||||||Week 3\&4 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.205
91739390|NCT04683913|183370832|OTHER|||||||0.162||||||Week 3\&4 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.162
91739391|NCT04683913|183370832|OTHER|||||||0.421||||||Week 5\&6 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.421
91739392|NCT04683913|183370837|SUPERIORITY|||||||0.75|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - pain subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.750
91739393|NCT04683913|183370837|SUPERIORITY|||||||0.201|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.201
91739394|NCT04683913|183370837|SUPERIORITY|||||||0.997|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.997
91531107|NCT05675709|182938553|SUPERIORITY|||||||0.05|||||||generalized estimating equation (GEE)|||||||.05
91739395|NCT04683913|183370837|SUPERIORITY|||||||0.423|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.423
91499306|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.1|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.10|
91739396|NCT04683913|183370838|SUPERIORITY|||||||0.342|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment 1 (early stance) was analyzed as raw Nm with body mass entered as as covariate.||||0.342
91739397|NCT04683913|183370838|SUPERIORITY|||||||0.844|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Adduction Moment 2 (late stance was analyzed as raw Nm with body mass entered as as covariate.||||0.844
91739398|NCT04683913|183370838|SUPERIORITY|||||||0.774|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariate||||0.774
91739399|NCT04683913|183370839|SUPERIORITY|||||||0.186|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.186
91739400|NCT04683913|183370839|SUPERIORITY|||||||0.601|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee flexion moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.601
91739401|NCT04046939|183370856|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.2283|||<|0.0001|TWO_SIDED|95.0|0.121|0.431||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.2283 represents the ratio of the 150 mg BID week 12 ratio to baseline (0.2051), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.2283 is equivalent to a -77.17% change compared to placebo at week 12.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.431|0.121|<.0001
91739402|NCT04046939|183370856|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.3403||||0.0014|TWO_SIDED|95.0|0.177|0.653||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.3403 represents the ratio of the 75 mg BID week 12 ratio to baseline (0.3056), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.3403 is equivalent to a -65.97% change compared to placebo at week 12.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.653|0.177|0.0014
91739403|NCT04046939|183370856|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.4489||||0.019|TWO_SIDED|95.0|0.231|0.874||A closed hierarchical statistical testing was used. The previous endpoint in the hierarchy was not statistically significant. Therefore, this endpoint was not formally tested and is not considered statistically significant, despite a p-value \<0.05.|Mixed Models Analysis||0.4489 represents the ratio of the 37.5 mg BID week 12 ratio to baseline (0.4031) compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.4489 is equivalent to a -55.11% change compared to placebo at week 12.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.874|0.231|0.0190
91739404|NCT04046939|183370857|SUPERIORITY||Mean Difference (Final Values)|0.0814||||0.4154|TWO_SIDED|95.0|-0.116|0.279||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||Estimate is the difference of the pooled 75 mg and 150 mg BID group from placebo in change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The combined 75 mg and 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.279|-0.116|0.4154
91739405|NCT04046939|183370857|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.1174|TWO_SIDED|95.0|-0.0456|0.4||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.400|-0.0456|0.1174
91499307|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.16|0.21||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.21|-0.16|
91739406|NCT04046939|183370857|SUPERIORITY||Mean Difference (Final Values)|-0.0143||||0.8998|TWO_SIDED|95.0|-0.24|0.211||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.211|-0.240|0.8998
91499308|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.06|0.45||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.06|
91531108|NCT05675709|182938554|SUPERIORITY|||||||0.05|||||||generalized estimating equation (GEE)|||||||.05
91739407|NCT04046939|183370857|SUPERIORITY||Mean Difference (Final Values)|0.138||||0.2425|TWO_SIDED|95.0|-0.095|0.37||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.370|-0.0950|0.2425
91739408|NCT04046939|183370858|SUPERIORITY||Mean Difference (Final Values)|-0.264||||0.3059|TWO_SIDED|95.0|-0.772|0.245||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.245|-0.772|0.3059
91739409|NCT04046939|183370858|SUPERIORITY||Mean Difference (Final Values)|-0.0457||||0.8642|TWO_SIDED|95.0|-0.575|0.484||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.484|-0.575|0.8642
91499309|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.19|0.7||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.70|0.19|
91739410|NCT04046939|183370858|SUPERIORITY||Mean Difference (Final Values)|-0.0276||||0.9182|TWO_SIDED|95.0|-0.56|0.505||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.505|-0.560|0.9182
91739411|NCT04046939|183370859|SUPERIORITY||Mean Difference (Final Values)|0.181||||0.0716|TWO_SIDED|95.0|-0.0163|0.378||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 150 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.378|-0.0163|0.0716
91739412|NCT04046939|183370859|SUPERIORITY||Mean Difference (Final Values)|0.00474||||0.9619|TWO_SIDED|95.0|-0.192|0.202||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 75 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.202|-0.192|0.9619
91739413|NCT04046939|183370859|SUPERIORITY||Median Difference (Final Values)|0.0987||||0.3368|TWO_SIDED|95.0|-0.105|0.302||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 37.5 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.302|-0.105|0.3368
91739414|NCT04046939|183370860|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.4512|TWO_SIDED|95.0|-0.338|0.755||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 150 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.755|-0.338|0.4512
91739415|NCT04046939|183370860|SUPERIORITY||Mean Difference (Final Values)|-0.0642||||0.8214|TWO_SIDED|95.0|-0.627|0.499||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 75 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.499|-0.627|0.8214
91739416|NCT04046939|183370860|SUPERIORITY||Mean Difference (Final Values)|0.154||||0.5894|TWO_SIDED|95.0|-0.411|0.72||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 37.5 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.720|-0.411|0.5894
91739417|NCT04046939|183370866|SUPERIORITY|||||||0.0196||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 150 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0196
91739418|NCT04046939|183370866|SUPERIORITY|||||||0.0207||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 75mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0207
91499310|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|0.04|
91499311|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.32|0.87||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.87|0.32|
91739419|NCT04046939|183370866|SUPERIORITY|||||||0.5399||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 37.5 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.5399
91739420|NCT04046939|183370867|SUPERIORITY||Mean Difference (Final Values)|-0.0233||||0.0084|TWO_SIDED|95.0|-0.0405|-0.00613||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00613|-0.0405|0.0084
91739421|NCT04046939|183370867|SUPERIORITY||Mean Difference (Final Values)|-0.0206||||0.0237|TWO_SIDED|95.0|-0.0384|-0.00281||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00281|-0.0384|0.0237
91739422|NCT04046939|183370867|SUPERIORITY||Mean Difference (Final Values)|-0.00215||||0.814|TWO_SIDED|95.0|-0.0203|0.016||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||0.0160|-0.0203|0.8140
91739423|NCT04046939|183370868|SUPERIORITY||Mean Difference (Final Values)|-8.24||||0.1886|TWO_SIDED|95.0|-20.6|4.13||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||4.13|-20.6|0.1886
91739424|NCT04046939|183370868|SUPERIORITY||Mean Difference (Final Values)|-6.53||||0.3061|TWO_SIDED|95.0|-19.1|6.08||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 75mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||6.08|-19.1|0.3061
91739425|NCT04046939|183370868|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.1294|TWO_SIDED|95.0|-23.4|3.04||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||3.04|-23.4|0.1294
91739426|NCT04704193|183370869|OTHER|This arm includes descriptive statistics only.|count with proportion|0.955|||||TWO_SIDED|95.0|0.888|0.987||||||"Descriptive statistics only/proportion reported good or excellent~Q1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk"||.987|.888|
91739427|NCT04704193|183370869|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1b. Genetic test results may help guide my treatment options"||.974|.856|
91739428|NCT04704193|183370869|OTHER|This arm includes descriptive statistics only.|count with proportion|0.943|||||TWO_SIDED|95.0|0.872|0.981||||||"Descriptive statistics only/proportion reported good or excellent~Q1c. Genetic test results may help me understand the future risks of other cancers"||.981|.872|
91739429|NCT04704193|183370869|OTHER|This arm includes descriptive statistics only.|count with proportion|0.851|||||TWO_SIDED|95.0|0.758|0.918||||||"Descriptive statistics only/proportion reported good or excellent~Q1d. Genetic test results may increase stress to me and my family members"||.918|.758|
91499312|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.16|0.4||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.16|
91739430|NCT04704193|183370869|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1e. There are 3 gene panel options that include either a small, medium, or large number of genes"||.974|.856|
91739431|NCT04704193|183370869|OTHER|This arm includes descriptive statistics only.|count with proportion|0.919|||||TWO_SIDED|95.0|0.839|0.967||||||"Descriptive statistics only/proportion reported good or excellent~Q1f. Gene test results may come back as positive, negative or uncertain"||.967|.839|
91739432|NCT04704193|183370870|OTHER|Summary statistics only|Mean|13.7|STANDARD_DEVIATION|5.6|||TWO_SIDED|||||||||||||
91739433|NCT03384875|183370871|SUPERIORITY||Risk Difference (RD)|0.0||||0.517|TWO_SIDED||||||Chi-squared|||||||0.517
91739434|NCT04551898|183370894|SUPERIORITY||Least square Mean|-0.25||||0.4829|TWO_SIDED|90.0|-0.84|0.34|||Mixed Models Analysis|||||0.34|-0.84|0.4829
91739435|NCT04551898|183370894|SUPERIORITY||Least square Mean|-0.51||||0.1739|TWO_SIDED|90.0|-1.13|0.11|||Mixed Models Analysis|||||0.11|-1.13|0.1739
91739436|NCT04551898|183370894|SUPERIORITY||Least square Mean|0.19||||0.6006|TWO_SIDED|90.0|-0.4|0.77|||Mixed Models Analysis|||||0.77|-0.40|0.6006
91739437|NCT04551898|183370894|SUPERIORITY|||||||0.4996||||||H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups|t-test, 1 sided|MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.||||||0.4996
91739438|NCT03427814|183370910|SUPERIORITY||||||=|0.1428|||||||Log Rank|The one-sided p-value was based on a stratified log-rank test.||||||= 0.1428
91739439|NCT03846427|183370917|SUPERIORITY|P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%|||||<|0.0001|||||||Binomial exact method|||||||<0.0001
91739440|NCT01334554|183370943|SUPERIORITY_OR_OTHER||Beta coefficient (linear regression)|0.12||||0.55|TWO_SIDED|95.0|-0.33|0.58||p- value was unadjusted. Primary outcome underwent logarithmic transformation|Regression, Linear|||H0= 4-week treatment with sildenafil citrate does not improve insulin sensitivity in obese African American women.||0.58|-0.33|0.55
91739441|NCT01334554|183370944|SUPERIORITY_OR_OTHER||Beta coefficient|0.46||||0.649|TWO_SIDED|95.0|-1.58|2.49||Adjusted for baseline values only|Regression, Linear|||||2.49|-1.58|0.649
91739442|NCT02393859|183370959|SUPERIORITY||Normal score|-11.54|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
91499313|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.12|0.68||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|0.12|
91739443|NCT02393859|183370959|SUPERIORITY||Normal score|-11.16||||0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
91739444|NCT02393859|183370959|SUPERIORITY||Stratified hazard ratio (HR)|0.36|||||TWO_SIDED|95.0|0.19|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.66|0.19|
91739445|NCT02393859|183370959|SUPERIORITY||Unstratified HR|0.39|||||TWO_SIDED|95.0|0.22|0.7|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.70|0.22|
91739446|NCT02393859|183370959|SUPERIORITY||Stratified HR w/time-dependent covariate|0.36|||||TWO_SIDED|95.0|0.2|0.64|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.64|0.20|
91739447|NCT02393859|183370960|SUPERIORITY||Normal score|-13.9|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
91739448|NCT02393859|183370960|SUPERIORITY||Normal score|-13.61|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for Blinatumomab relative to HC3 and therefore a longer event free survival time.|||||< 0.001
91739449|NCT02393859|183370960|SUPERIORITY||Stratified HR|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.61|0.20|
91739450|NCT02393859|183370960|SUPERIORITY||Unstratified HR|0.38|||||TWO_SIDED|95.0|0.22|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.65|0.22|
91739451|NCT02393859|183370960|SUPERIORITY||Stratified HR w/time-dependent covariate|0.34|||||TWO_SIDED|95.0|0.2|0.59|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.59|0.20|
91739452|NCT02393859|183370961|SUPERIORITY||Normal score|-10.14||||0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
91739453|NCT02393859|183370961|SUPERIORITY||Normal score|-10.32|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
91739454|NCT02393859|183370961|SUPERIORITY||Stratified HR|0.33|||||TWO_SIDED|95.0|0.16|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.66|0.16|
91739455|NCT02393859|183370961|SUPERIORITY||Unstratified HR|0.32|||||TWO_SIDED|95.0|0.16|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.65|0.16|
91739456|NCT02393859|183370962|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by PCR||||< 0.001
91739457|NCT02393859|183370962|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by flow cytometry||||< 0.001
91739458|NCT02393859|183370963|SUPERIORITY||Hazard Ratio (HR)|0.29|||||TWO_SIDED|95.0|0.16|0.52|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)|||0.52|0.16|
91739459|NCT02393859|183370963|SUPERIORITY||Stratified hazard ratio (HR)|0.27|||||TWO_SIDED|95.0|0.15|0.48|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.|||0.48|0.15|
91739460|NCT00954447|183370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.74|-0.55|||ANCOVA||Linagliptin 5mg - Placebo|||-0.55|-0.74|<0.0001
91739461|NCT00954447|183370972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.935|||<|0.0001||95.0|1.949|4.419|||Regression, Logistic|Logistic regression of HbA1c \< 7.0 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg||4.419|1.949|<0.0001
91739462|NCT00954447|183370974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.51|-0.39|||ANCOVA||Linagliptin 5mg - Placebo|||-0.39|-0.51|<0.0001
91499314|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.05|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.05|
91499315|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.4|1.01||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.01|0.40|
91499316|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.19|0.4||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.19|
91739463|NCT00954447|183370975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.69|-0.52|||ANCOVA||Linagliptin 5mg - Placebo|||-0.52|-0.69|<0.0001
91739464|NCT00954447|183370976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.76|-0.57|||ANCOVA||Linagliptin 5mg - Placebo|||-0.57|-0.76|<0.0001
91739465|NCT00954447|183370977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.67|-0.47|||ANCOVA||Linagliptin 5mg - Placebo|||-0.47|-0.67|<0.0001
91739466|NCT00954447|183370978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.65|-0.45|||ANCOVA||Linagliptin 5mg - Placebo|||-0.45|-0.65|<0.0001
91739467|NCT00954447|183370979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.64|-0.43|||ANCOVA||Linagliptin 5mg - Placebo|||-0.43|-0.64|<0.0001
91739468|NCT00954447|183370980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001||95.0|-16.49|-6.71|||ANCOVA||Linagliptin 5mg - Placebo|||-6.71|-16.49|<0.0001
91739469|NCT00954447|183370983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.53||0.0029||95.0|-2.61|-0.54|||ANCOVA||Linagliptin 5mg - Placebo|||-0.54|-2.61|0.0029
91739470|NCT00954447|183370986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.327|||<|0.0001||95.0|2.221|8.43|||Regression, Logistic|Logistic regression of HbA1c \< 6.5 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg||8.430|2.221|<0.0001
91739471|NCT01979614|183370987|SUPERIORITY_OR_OTHER||Standard Error|-0.1116||||0.438|TWO_SIDED|95.0|-0.399|0.176|||ANCOVA|||SAP for Global Myocardial Perfusion Reserve Index (MPRI)||0.176|-0.399|0.438
91739472|NCT04971967|183371052|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
91739473|NCT04971967|183371053|SUPERIORITY|||||||0.3|||||||Generalized linear regression|||||||0.30
91739474|NCT04971967|183371055|SUPERIORITY|||||||0.28|||||||Generalized linear regression|||||||0.28
91739475|NCT04971967|183371057|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
91739476|NCT04971967|183371058|SUPERIORITY|||||||0.11|||||||Generalized linear regression|||||||0.11
91739477|NCT00052910|183371059|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.99|||||TWO_SIDED|95.0|0.79|1.24|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.24|0.79|
91739478|NCT00052910|183371060|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.83|1.28|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.28|0.83|
91739479|NCT03181971|183371124|SUPERIORITY||Odds Ratio (OR)|0.7||||0.68|TWO_SIDED|95.0|0.2|2.9|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.9|0.2|0.68
91499317|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.49||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.49|-0.10|
91499318|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.16|0.43||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.43|-0.16|
91499319|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|0.41|1.06||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.06|0.41|
91739480|NCT03181971|183371124|SUPERIORITY||Odds Ratio (OR)|0.1||||0.017|TWO_SIDED|95.0|0.03|0.7|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months||0.7|0.03|0.017
91739481|NCT03181971|183371125|SUPERIORITY||Odds Ratio (OR)|0.4||||0.24|TWO_SIDED|95.0|0.07|2.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.0|0.07|.24
91739482|NCT03181971|183371125|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.1|7.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||7.0|0.1|.98
91739483|NCT03181971|183371126|SUPERIORITY||Adjusted mean difference|0.2||||0.57|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||1.0|-0.6|0.57
91739484|NCT03181971|183371126|SUPERIORITY||Adjusted mean difference|-0.5||||0.4|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.6|-1.5|.40
91739485|NCT03181971|183371127|SUPERIORITY||Adjusted mean difference|0.04||||0.46|TWO_SIDED|95.0|-0.06|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.1|-0.06|.46
91531109|NCT01254565|182938562|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-76.9|||<|0.0001|TWO_SIDED|95.0|-86.9|-50.0|||ANOVA|A rank analysis of variance (ANOVA) model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-50.0|-86.9|<0.0001
91739486|NCT03181971|183371127|SUPERIORITY||Adjusted mean difference|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.1|-0.2|.80
91739487|NCT03181971|183371128|SUPERIORITY||Adjusted mean difference|0.001||||0.93|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.03|-0.03|.93
91739488|NCT03181971|183371128|SUPERIORITY||Adjusted mean difference|-0.02||||0.36|TWO_SIDED|95.0|-0.06|0.02|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.02|-0.06|.36
91739489|NCT03181971|183371129|SUPERIORITY||Percent difference in change|1.4||||0.7|TWO_SIDED|95.0|-5.3|8.5||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in total kcal intake from baseline to 7 months.||8.5|-5.3|0.70
91739490|NCT03181971|183371129|SUPERIORITY||Percent difference in change|3.7||||0.35|TWO_SIDED|95.0|-3.9|12.0||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in intake of food kcal from baseline to 7 months.||12.0|-3.9|.35
91739491|NCT03181971|183371129|SUPERIORITY||Percent difference in change|-10.6||||0.35|TWO_SIDED|95.0|-29.2|8.8|||Mixed Models Analysis|||Analysis of between group change in intake of beverage kcal from baseline to 7 months.||8.8|-29.2|.35
91739492|NCT03181971|183371129|SUPERIORITY||Percent difference in change|-17.5||||0.18|TWO_SIDED|95.0|-37.8|9.6|||Mixed Models Analysis|||Analysis of between group change in SSB kcal from baseline to 7 months.||9.6|-37.8|.18
91739493|NCT03181971|183371130|SUPERIORITY||Percent difference in change|9.1||||0.59|TWO_SIDED|95.0|-20.6|49.9||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||49.9|-20.6|.59
91739494|NCT03181971|183371131|SUPERIORITY||Percent difference in change|23.2|||<|0.001|TWO_SIDED|95.0|13.1|34.2|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 7 months.||34.2|13.1|<.001
91739495|NCT03181971|183371131|SUPERIORITY||Percent difference in change|14.7||||0.004|TWO_SIDED|95.0|4.5|25.9|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 15 months.||25.9|4.5|.004
91739496|NCT03181971|183371131|SUPERIORITY||Percent difference in change|-8.0||||0.063|TWO_SIDED|95.0|-15.7|0.4|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 7 months.||0.4|-15.7|0.063
91739497|NCT03181971|183371131|SUPERIORITY||Percent difference in change|-2.8||||0.56|TWO_SIDED|95.0|-11.7|6.9|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 15 months.||6.9|-11.7|.56
91739498|NCT03181971|183371131|SUPERIORITY||Percent difference in change|1.2||||0.68|TWO_SIDED|95.0|-4.3|7.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 7 months.||7|-4.3|.68
91739499|NCT03181971|183371131|SUPERIORITY||Percent difference in change|-1.4||||0.66|TWO_SIDED|95.0|-7.4|5.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 15 months.||5|-7.4|.66
91739500|NCT03181971|183371131|SUPERIORITY||Percent difference in change|-4.0||||0.079|TWO_SIDED|95.0|-8.3|0.5|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 7 months.||0.5|-8.3|0.079
91499320|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.01|0.64||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|0.01|
91499321|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.01|0.62||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.01|
91499322|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.08|0.71||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.71|0.08|
91499323|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.92|1.61||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.61|0.92|
91499324|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.04|0.76||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|0.04|
91499325|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.03|0.69||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.69|-0.03|
91499326|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.05|0.77||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.05|
91739501|NCT03181971|183371131|SUPERIORITY||Percent difference in change|-3.0||||0.26|TWO_SIDED|95.0|-8.0|2.3|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 15 months.||2.3|-8.0|.26
91739502|NCT03181971|183371131|SUPERIORITY||Percent difference in change|4.4||||0.2|TWO_SIDED|95.0|-2.2|11.5|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 7 months.||11.5|-2.2|.20
91499327|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.92|1.68||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.68|0.92|
91499328|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.16|0.95||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.95|0.16|
91499329|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.17|0.97||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.97|0.17|
91499330|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.24|1.03||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.24|
91705189|NCT05153148|183304902|SUPERIORITY||Treatment Difference|-10.9|||=|0.003|TWO_SIDED|95.0|-18.2|-3.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.6|-18.2|=0.003
91739503|NCT03181971|183371131|SUPERIORITY||Percent difference in change|2.3||||0.51|TWO_SIDED|95.0|-4.4|9.6|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 15 months.||9.6|-4.4|.51
91739504|NCT03181971|183371132|SUPERIORITY||Percent difference in change|31.3|||<|0.001|TWO_SIDED|95.0|21.2|42.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at lunch from baseline to 7 months.||42.2|21.2|<.001
91739505|NCT03181971|183371132|SUPERIORITY||Percent difference in change|4.9||||0.22|TWO_SIDED|95.0|-3.0|13.5|||Mixed Models Analysis|||Analysis of between group change in water intake from water source during lunch from baseline to 15 months.||13.5|-3.0|.22
91739506|NCT03181971|183371132|SUPERIORITY||Percent difference in change|17.0||||0.02|TWO_SIDED|95.0|2.6|33.3|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 7 months.||33.3|2.6|.02
91705190|NCT05153148|183304903|SUPERIORITY||Treatment Difference|-0.07|||=|0.357|TWO_SIDED|95.0|-0.21|0.08|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.08|-0.21|=0.357
91499331|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.97|1.78||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.78|0.97|
91499332|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.08|0.92||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.92|0.08|
91499333|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.03|0.84||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.84|-0.03|
91499334|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.09|0.93||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.93|0.09|
91499335|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.75|1.59||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.59|0.75|
91499336|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.72||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.27|
91739507|NCT03181971|183371132|SUPERIORITY||Percent difference in change|4.7||||0.48|TWO_SIDED|95.0|-8.0|19.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 15 months.||19.2|-8.0|.48
91739508|NCT03181971|183371132|SUPERIORITY||Percent difference in change|34.6||||0.14|TWO_SIDED|95.0|-9.4|99.8|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 7 months.||99.8|-9.4|.14
91739509|NCT03181971|183371132|SUPERIORITY||Percent difference in change|32.1||||0.16|TWO_SIDED|95.0|-11.0|96.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 15 months.||96.2|-11.0|.16
91739510|NCT04343092|183371135|SUPERIORITY||Mean Difference (Final Values)|7.92||||0.05|TWO_SIDED||||||t-test, 2 sided||||Historical control population included: Hydroxychloroquin (HCQ) 400mg BID at admission day then 200mg BID for 5 days plus Azithromycin (AZT) 500mg at admission day then 250mg for 5 days.|||0.05
91739511|NCT00803738|183371136|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary clinical equivalence analysis, a 90% confidence interval was constructed on the difference in the therapeutic cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.3|15.02|||Wald's method with Yates' continuity|||||15.02|-4.30|
91739512|NCT00803738|183371137|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the mycological cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.66|11.49|||Wald's method with Yates' continuity|||||11.49|-4.66|
91739513|NCT00803738|183371138|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the clinical cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-1.35|16.88|||Wald's method with Yates' continuity|||||16.88|-1.35|
91739514|NCT03012334|183371161|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in Standard Deviation of Lateral Position (SDLP) between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|9.86|||<|0.001|TWO_SIDED|95.0|7.39|12.33||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||12.33|7.39|<.001
91739515|NCT03012334|183371161|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|15.35|||<|0.001|TWO_SIDED|95.0|12.87|17.82||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||17.82|12.87|<0.001
91499337|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.37|0.65||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.65|-0.37|
91499338|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.23|0.77||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|-0.23|
91499339|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.33|1.31||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.31|0.33|
91499340|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.24|0.89||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.89|-0.24|
91499341|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.25|0.94||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.25|
91499342|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.31|0.8||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.31|
91705191|NCT05153148|183304903|SUPERIORITY||Treatment Difference|-0.1|||=|0.195|TWO_SIDED|95.0|-0.24|0.05|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.05|-0.24|=0.195
91499343|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.08|1.19||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.19|0.08|
91705192|NCT05153148|183304903|SUPERIORITY||Treatment Difference|-0.05|||=|0.467|TWO_SIDED|95.0|-0.2|0.09|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.09|-0.20|=0.467
91705193|NCT05153148|183304904|SUPERIORITY||Treatment Difference|1.3|||=|0.031|TWO_SIDED|95.0|0.1|2.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|2.4|0.1|=0.031
91705194|NCT05153148|183304904|SUPERIORITY||Treatment Difference|0.1|||=|0.86|TWO_SIDED|95.0|-1.1|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-1.1|=0.860
91705195|NCT05153148|183304904|SUPERIORITY||Treatment Difference|0.2|||=|0.758|TWO_SIDED|95.0|-0.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-0.9|=0.758
91705196|NCT05153148|183304905|SUPERIORITY||Treatment Difference|-0.5|||=|0.131|TWO_SIDED|95.0|-1.2|0.2|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.2|-1.2|=0.131
91705197|NCT05153148|183304905|SUPERIORITY||Treatment Difference|-0.7|||=|0.043|TWO_SIDED|95.0|-1.3|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-1.3|=0.043
91705198|NCT05153148|183304905|SUPERIORITY||Treatment Difference|-0.1|||=|0.687|TWO_SIDED|95.0|-0.8|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-0.8|=0.687
91705199|NCT05153148|183304906|SUPERIORITY||Risk Difference (RD)|5.6|||=|0.349|TWO_SIDED|95.0|-6.1|17.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|17.4|-6.1|=0.349
91705200|NCT05153148|183304906|SUPERIORITY||Risk Difference (RD)|15.5|||=|0.017|TWO_SIDED|95.0|2.8|28.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.3|2.8|=0.017
91499344|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.07|0.83||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.83|0.07|
91739516|NCT03012334|183371161|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|21.06|||<|0.001|TWO_SIDED|95.0|18.6|23.52||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||23.52|18.60|<0.001
91739517|NCT03012334|183371161|SUPERIORITY||LS Mean|22.71|||<|0.001|TWO_SIDED|95.0|20.23|25.18|||Mixed Models Analysis|||||25.18|20.23|<0.001
91499345|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.36|0.44||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.36|
91499346|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.07|0.68||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|-0.07|
91499347|NCT01529346|182868246|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.45||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.32|
91499348|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.43|3.71||||||SPID(6): LS mean estimate of the treatment difference along with 90% confidence interval (CI) were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.71|0.43|
91499349|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.05|3.33||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.33|0.05|
91499350|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|0.69|3.99||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.99|0.69|
91499351|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|6.99|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|5.19|8.79||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||8.79|5.19|
91499352|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|1.97|17.63||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||17.63|1.97|
91499353|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|-4.28|11.37||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||11.37|-4.28|
91499354|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|10.82|STANDARD_ERROR_OF_MEAN|4.76|||TWO_SIDED|90.0|2.97|18.68||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||18.68|2.97|
91739518|NCT03012334|183371161|SUPERIORITY||LS Mean|-12.85|||<|0.001|TWO_SIDED|95.0|-15.32|-10.38|||Mixed Models Analysis|||||-10.38|-15.32|<0.001
91499355|NCT01529346|182868247|SUPERIORITY_OR_OTHER||LS Mean Difference|22.39|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|13.82|30.97||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||30.97|13.82|
91499356|NCT01529346|182868248|SUPERIORITY_OR_OTHER||LS Mean Difference|12.26|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|1.26|23.27||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||23.27|1.26|
91499357|NCT01529346|182868248|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|-6.82|15.18||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||15.18|-6.82|
91499358|NCT01529346|182868248|SUPERIORITY_OR_OTHER||LS Mean Difference|12.57|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|90.0|1.52|23.61||||||||23.61|1.52|
91499359|NCT01529346|182868248|SUPERIORITY_OR_OTHER||LS Mean Difference|32.56|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|90.0|20.51|44.61||||||||44.61|20.51|
91739519|NCT03012334|183371161|SUPERIORITY||LS Mean|-7.36|||<|0.001|TWO_SIDED|95.0|-9.84|-4.88|||Mixed Models Analysis|||||-4.88|-9.84|<0.001
91739520|NCT03012334|183371161|SUPERIORITY||LS Mean|-1.65||||0.19|TWO_SIDED|95.0|-4.11|0.82|||Mixed Models Analysis|||||0.82|-4.11|0.19
91739521|NCT03012334|183371162|SUPERIORITY||LS Mean|1.6|||<|0.0001|TWO_SIDED|95.0|1.1744|2.0335|||Mixed Models Analysis|||||2.0335|1.1744|<0.0001
91739522|NCT03012334|183371162|SUPERIORITY||LS Mean|2.3|||<|0.0001|TWO_SIDED|95.0|1.8306|2.6926|||Mixed Models Analysis|||||2.6926|1.8306|<.0001
91739523|NCT03012334|183371162|SUPERIORITY||LS Mean|2.9|||<|0.0001|TWO_SIDED|95.0|2.4239|3.28|||Mixed Models Analysis|||||3.2800|2.4239|<0.0001
91739524|NCT03012334|183371162|SUPERIORITY||LS Mean|3.4|||<|0.0001|TWO_SIDED|95.0|2.9568|3.8193|||Mixed Models Analysis|||||3.8193|2.9568|<0.0001
91739525|NCT03012334|183371162|SUPERIORITY||LS Mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2137|-1.3546|||Mixed Models Analysis|||||-1.3546|-2.2137|<0.0001
91739526|NCT03012334|183371162|SUPERIORITY||LS Mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5574|-0.6956|||Mixed Models Analysis|||||-0.6956|-1.5574|<0.0001
91739527|NCT03012334|183371162|SUPERIORITY||LS Mean|-0.5||||0.0142|TWO_SIDED|95.0|-0.9642|-0.1081|||Mixed Models Analysis|||||-0.1081|-0.9642|0.0142
91739528|NCT03012334|183371164|SUPERIORITY||LS Mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.6895|-6.5006|||Mixed Models Analysis|||||-6.5006|-18.6895|<.0001
91739529|NCT03012334|183371164|SUPERIORITY||LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-30.3631|-18.1357|||Mixed Models Analysis|||||-18.1357|-30.3631|<.0001
91739530|NCT03012334|183371164|SUPERIORITY||LS Mean|-28.4|||<|0.0001|TWO_SIDED|95.0|-34.442|-22.2897|||Mixed Models Analysis|||||-22.2897|-34.4420|<.0001
91739531|NCT03012334|183371164|SUPERIORITY||LS Mean|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.5068|-24.277|||Mixed Models Analysis|||||-24.2770|-36.5068|<0.0001
91739532|NCT03012334|183371164|SUPERIORITY||LS Mean|17.8|||<|0.0001|TWO_SIDED|95.0|11.7029|23.8908|||Mixed Models Analysis|||||23.8908|11.7029|<.0001
91499360|NCT01529346|182868249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.6|
91499361|NCT01529346|182868249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.9|1.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.9|
91499362|NCT01529346|182868249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.6|0.7|
91739533|NCT03012334|183371164|SUPERIORITY||LS Mean|6.1||||0.0489|TWO_SIDED|95.0|0.0297|12.2554|||Mixed Models Analysis|||||12.2554|0.0297|0.0489
91739534|NCT03012334|183371164|SUPERIORITY||LS Mean|2.0||||0.5123|TWO_SIDED|95.0|-4.05|8.1021|||Mixed Models Analysis|||||8.1021|-4.0500|0.5123
91739535|NCT03012334|183371164|SUPERIORITY||LS Mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-32.4956|-20.3628|||Mixed Models Analysis|||||-20.3628|-32.4956|<.0001
91739536|NCT03012334|183371164|SUPERIORITY||LS Mean|-37.8|||<|0.0001|TWO_SIDED|95.0|-43.927|-31.7537|||Mixed Models Analysis|||||-31.7537|-43.9270|<.0001
91739537|NCT03012334|183371164|SUPERIORITY||LS Mean|-46.8|||<|0.0001|TWO_SIDED|95.0|-52.8147|-40.7268|||Mixed Models Analysis|||||-40.7268|-52.8147|<.0001
91739538|NCT03012334|183371164|SUPERIORITY||LS Mean|-52.6|||<|0.0001|TWO_SIDED|95.0|-58.649|-46.4682|||Mixed Models Analysis|||||-46.4682|-58.6490|<0.0001
91739539|NCT03012334|183371164|SUPERIORITY||LS Mean|26.1|||<|0.0001|TWO_SIDED|95.0|20.0635|32.1953|||Mixed Models Analysis|||||32.1953|20.0635|<.0001
91739540|NCT03012334|183371164|SUPERIORITY||LS Mean|14.7|||<|0.0001|TWO_SIDED|95.0|8.6325|20.804|||Mixed Models Analysis|||||20.8040|8.6325|<.0001
91739541|NCT03012334|183371164|SUPERIORITY||LS Mean|5.8||||0.0605|TWO_SIDED|95.0|-0.256|11.8317|||Mixed Models Analysis|||||11.8317|-0.2560|0.0605
91739542|NCT03012334|183371165|SUPERIORITY||LS Mean|-4.5|||<|0.001|TWO_SIDED|95.0|-6.14|-2.85|||Mixed Models Analysis|||||-2.85|-6.14|<0.001
91739543|NCT03012334|183371165|SUPERIORITY||LS Mean|-6.9|||<|0.001|TWO_SIDED|95.0|-8.58|-5.28|||Mixed Models Analysis|||||-5.28|-8.58|<0.001
91739544|NCT03012334|183371165|SUPERIORITY||LS Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-10.52|-7.23|||Mixed Models Analysis|||||-7.23|-10.52|<0.001
91739545|NCT03012334|183371165|SUPERIORITY||LS Mean|-11.2|||<|0.001|TWO_SIDED|95.0|-12.81|-9.51|||Mixed Models Analysis|||||-9.51|-12.81|<0.001
91739546|NCT03012334|183371165|SUPERIORITY||LS Mean|6.7|||<|0.001|TWO_SIDED|95.0|5.02|8.31|||Mixed Models Analysis|||||8.31|5.02|<0.001
91739547|NCT03012334|183371165|SUPERIORITY||LS Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.58|5.88|||Mixed Models Analysis|||||5.88|2.58|<0.001
91739548|NCT03012334|183371165|SUPERIORITY||LS Mean|2.3|||<|0.007|TWO_SIDED|95.0|0.64|3.93|||Mixed Models Analysis|||||3.93|0.64|<0.007
91739549|NCT03012334|183371166|SUPERIORITY||LS Mean|1.439|||<|0.0001|TWO_SIDED|95.0|1.2198|1.6583|||Mixed Models Analysis|||||1.6583|1.2198|<0.0001
91739550|NCT03012334|183371166|SUPERIORITY||LS Mean|2.018|||<|0.0001|TWO_SIDED|95.0|1.7981|2.238|||Mixed Models Analysis|||||2.2380|1.7981|<0.0001
91739551|NCT03012334|183371166|SUPERIORITY||LS Mean|2.572|||<|0.0001|TWO_SIDED|95.0|2.3536|2.7909|||Mixed Models Analysis|||||2.7909|2.3536|<0.0001
91739552|NCT03012334|183371166|SUPERIORITY||LS Mean|2.553|||<|0.0001|TWO_SIDED|95.0|2.3331|2.773|||Mixed Models Analysis|||||2.7730|2.3331|<0.0001
91739553|NCT03012334|183371166|SUPERIORITY||LS Mean|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.3333|-0.8948|||Mixed Models Analysis|||||-0.8948|-1.3333|<0.0001
91739554|NCT03012334|183371166|SUPERIORITY||LS Mean|-0.535|||<|0.0001|TWO_SIDED|95.0|-0.7549|-0.3151|||Mixed Models Analysis|||||-0.3151|-0.7549|<0.0001
91739555|NCT03012334|183371166|SUPERIORITY||LS Mean|0.019||||0.8629|TWO_SIDED|95.0|-0.1995|0.2379|||Mixed Models Analysis|||||0.2379|-0.1995|0.8629
91739556|NCT03012334|183371168|SUPERIORITY||LS Mean|0.18||||0.0002|TWO_SIDED|95.0|0.0849|0.2746|||Mixed Models Analysis|||||0.2746|0.0849|0.0002
91739557|NCT03012334|183371168|SUPERIORITY||LS Mean|0.303|||<|0.0001|TWO_SIDED|95.0|0.2082|0.3985|||Mixed Models Analysis|||||0.3985|0.2082|<.0001
91739558|NCT03012334|183371168|SUPERIORITY||LS Mean|0.372|||<|0.0001|TWO_SIDED|95.0|0.277|0.4662|||Mixed Models Analysis|||||0.4662|0.2770|<.0001
91739559|NCT03012334|183371168|SUPERIORITY||LS Mean|0.603|||<|0.0001|TWO_SIDED|95.0|0.508|0.6983|||Mixed Models Analysis|||||0.6983|0.5080|<.0001
91739560|NCT03012334|183371168|SUPERIORITY||LS Mean|-0.423|||<|0.0001|TWO_SIDED|95.0|-0.5183|-0.3286|||Mixed Models Analysis|||||-0.3286|-0.5183|<.0001
91739561|NCT03012334|183371168|SUPERIORITY||LS Mean|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.3949|-0.2047|||Mixed Models Analysis|||||-0.2047|-0.3949|<0.0001
91739562|NCT03012334|183371168|SUPERIORITY||LS Mean|-0.232|||<|0.0001|TWO_SIDED|95.0|-0.3261|-0.137|||Mixed Models Analysis|||||-0.1370|-0.3261|<0.0001
91739563|NCT00328172|183371181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3271||95.0|-0.41|0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 0.5 mg versus placebo||0.14|-0.41|0.3271
91739564|NCT00328172|183371181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0032||95.0|-0.69|-0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 2.5 mg versus placebo||-0.14|-0.69|0.0032
91499363|NCT01529346|182868249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.0|2.4||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|1.0|
91739565|NCT00328172|183371181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0012||95.0|-0.74|-0.18|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.18|-0.74|0.0012
91739566|NCT00328172|183371181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.1|-0.59|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Metformin versus placebo||-0.59|-1.1|<0.0001
91739567|NCT00328172|183371182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.7027||95.0|-10.0|15.1|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 0.5 mg versus placebo||15.1|-10|0.7027
91739568|NCT00328172|183371182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.003||95.0|-32.0|-6.6|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 2.5 mg versus placebo||-6.6|-32|0.003
91739569|NCT00328172|183371182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.0418||95.0|-26.0|-0.5|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.5|-26|0.0418
91739570|NCT00328172|183371182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.3|||<|0.0001||95.0|-47.0|-22.0|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||||-22|-47|< 0.0001
91739571|NCT00328172|183371183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.735||||0.413||95.0|0.464|6.492|||Regression, Logistic|||Linagliptin 0.5 mg versus placebo||6.492|0.464|0.413
91739572|NCT00328172|183371183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.157||||0.842||95.0|0.275|4.861|||Regression, Logistic|||Linagliptin 2.5 mg versus placebo||4.861|0.275|0.842
91739573|NCT00328172|183371183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.364||95.0|0.492|6.91|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||6.910|0.492|0.364
91739574|NCT00328172|183371183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.224||||0.005||95.0|1.648|16.562|||Regression, Logistic|||Metformin versus placebo||16.562|1.648|0.005
91739575|NCT00077974|183371184|SUPERIORITY_OR_OTHER||Percent|33.0||||||95.0|24.2|42.8|||||Using exact method based on binomial distribution. Percent equals n divided by N times 100.|||42.8|24.2|
91499364|NCT01529346|182868250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|90.0|1.1|3.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||3.8|1.1|
91499365|NCT01529346|182868250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6|||||TWO_SIDED|90.0|1.4|4.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.9|1.4|
91739576|NCT04512001|183371242|EQUIVALENCE|Margins for results to be considered equivalent: -0.6 to 0.5.|Least squares means difference|0.01|||||TWO_SIDED|90.0|-0.16|0.18||||||||0.18|-0.16|
91739577|NCT04512001|183371244|EQUIVALENCE|Margins for results to be considered equivalent: -15%, 15%.|Difference in % Response Rate|-3.94|||||TWO_SIDED|95.0|-9.97|2.11||||||||2.11|-9.97|
91739578|NCT03896477|183371275|OTHER||GMC Ratio|2.91|||||TWO_SIDED|95.0|2.47|3.44||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||3.44|2.47|
91739579|NCT03896477|183371275|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.23|1.69||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.69|1.23|
91739580|NCT03896477|183371275|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.66|2.25||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.25|1.66|
91739581|NCT03896477|183371275|OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.88|0.65|
91739582|NCT03896477|183371275|OTHER||GMC Ratio|16.03|||||TWO_SIDED|95.0|12.84|20.03||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||20.03|12.84|
91739583|NCT03896477|183371275|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.06|0.72|
91739584|NCT03896477|183371275|OTHER||GMC Ratio|2.51|||||TWO_SIDED|95.0|2.14|2.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.95|2.14|
91739585|NCT03896477|183371275|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.95|0.68|
91739586|NCT03896477|183371275|OTHER||GMC Ratio|2.11|||||TWO_SIDED|95.0|1.83|2.44||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.44|1.83|
91739587|NCT03896477|183371275|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.91|
91739588|NCT03896477|183371275|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.21|1.65||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.65|1.21|
91739589|NCT03896477|183371275|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.76|1.05||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.05|0.76|
91739590|NCT03896477|183371275|OTHER||GMC Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.1||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.10|1.29|
91739591|NCT03896477|183371275|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.73|1.12||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.12|0.73|
91739592|NCT03896477|183371275|OTHER||GMC Ratio|3.69|||||TWO_SIDED|95.0|2.91|4.67||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||4.67|2.91|
91739593|NCT03896477|183371275|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.87||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.87|0.60|
91739594|NCT03896477|183371275|OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.79||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.79|0.52|
91739595|NCT03896477|183371275|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.89||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.89|0.62|
91739596|NCT03896477|183371275|OTHER||GMC Ratio|2.29|||||TWO_SIDED|95.0|1.89|2.76||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.76|1.89|
91739597|NCT03896477|183371275|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.82|
91739598|NCT01106157|183371294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.134||0.017|TWO_SIDED|95.0|0.001|0.552|||t-test, 2 sided|||||0.552|0.001|0.017
91739599|NCT01106157|183371295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.43|TWO_SIDED|95.0|-0.3|0.13|||t-test, 2 sided|||||0.13|-0.30|0.43
91739600|NCT01106157|183371296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.7||0.37|TWO_SIDED|95.0|-1.64|0.63|||t-test, 2 sided|||||0.63|-1.64|0.37
91739601|NCT01106157|183371297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED|95.0|-0.4|0.27|||t-test, 2 sided|||||0.27|-0.40|0.69
91739602|NCT01106157|183371298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.75|STANDARD_ERROR_OF_MEAN|81.3||0.89|TWO_SIDED|95.0|-156.8|180.3|||t-test, 2 sided|||||180.3|-156.8|0.89
91739603|NCT01106157|183371299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.15|0.7|||t-test, 2 sided|||||0.70|-0.15|0.2
91739604|NCT01106157|183371300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.13|STANDARD_ERROR_OF_MEAN|19.61||0.23|TWO_SIDED|95.0|-64.8|16.7|||t-test, 2 sided|||||16.7|-64.8|0.23
91739605|NCT01106157|183371301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.1||0.79|TWO_SIDED|95.0|-0.18|0.23|||t-test, 2 sided|||||0.23|-0.18|0.79
91739606|NCT01106157|183371302|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|5.33||0.163|TWO_SIDED|95.0|-18.7|3.35|||t-test, 2 sided|||||3.35|-18.7|0.163
91739607|NCT01120405|183371319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.|Difference of proportion|0.19||||0.0052|TWO_SIDED|95.0|-6.7|7.07|||Difference of proportion|||"The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc \< 10%.~As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included."||7.07|-6.70|0.0052
91739608|NCT01120405|183371320|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.7715|TWO_SIDED|95.0|-3.9|5.25|||Difference of proportion|||||5.25|-3.90|0.7715
91739609|NCT01120405|183371321|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.4763|TWO_SIDED|95.0|-1.19|2.54|||Difference of proportion|||||2.54|-1.19|0.4763
91739610|NCT01120405|183371322|SUPERIORITY_OR_OTHER||Difference of proportion|-0.34||||0.6533|TWO_SIDED|95.0|-1.82|1.14|||Difference of proportion|||||1.14|-1.82|0.6533
91739611|NCT01120405|183371323|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.1559|TWO_SIDED|95.0|-0.26|1.61|||Difference of proportion|||||1.61|-0.26|0.1559
91739612|NCT01120405|183371325|SUPERIORITY_OR_OTHER||Difference of proportion|1.69||||0.6056|TWO_SIDED|95.0|-4.74|8.13|||Difference of proportion|||||8.13|-4.74|0.6056
91739613|NCT01953211|183371350|SUPERIORITY_OR_OTHER||Slope|0.02|STANDARD_DEVIATION|0.57||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
91499366|NCT01529346|182868250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.2|||||TWO_SIDED|90.0|1.1|4.1||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.1|1.1|
91499367|NCT01529346|182868250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.3|||||TWO_SIDED|90.0|2.8|9.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||9.9|2.8|
91499368|NCT01529346|182868251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.4|1.0||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.0|0.4|
91499369|NCT01529346|182868251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.2||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.2|0.5|
91739614|NCT01953211|183371350|SUPERIORITY_OR_OTHER||Slope|0.63|STANDARD_DEVIATION|0.9|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91739615|NCT01953211|183371350|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_DEVIATION|0.78|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91739616|NCT01628523|183371352|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
91739617|NCT00768261|183371353|OTHER|||||||0.095|TWO_SIDED|95.0|||||ANOVA|df= 3,92||||||0.095
91739618|NCT00768261|183371354|OTHER|||||||0.066|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.066
91739619|NCT00768261|183371354|OTHER|||||||0.009|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.009
91499370|NCT01529346|182868251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|90.0|0.3|0.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.8|0.3|
91499371|NCT01529346|182868251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|90.0|0.2|0.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.6|0.2|
91499372|NCT02282020|182868270|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.4|4.58|||Regression, Logistic|Model includes a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months)|An odds ratio \>1 favours the olaparib arm|||4.58|1.40|0.002
91499373|NCT02282020|182868271|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.013|TWO_SIDED|95.0|0.43|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.43|0.013
91499374|NCT02282020|182868272|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.229|TWO_SIDED|95.0|0.56|1.15||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.15|0.56|0.229
91739620|NCT00768261|183371354|OTHER|||||||0.3|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.30
91739621|NCT00768261|183371354|OTHER|||||||0.0288|TWO_SIDED|95.0|||||Repeated Measures ANOVA|||RM-ANOVA on hippocampal volume slope||||0.0288
91739622|NCT00120627|183371362|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|F (1,144) = 4.12, p \< .05||2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA||||<0.05
91739623|NCT00120627|183371362|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
91739624|NCT00120627|183371363|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||||<0.05
91739625|NCT00120627|183371364|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)||||<0.0001
91739626|NCT00120627|183371365|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91739627|NCT00120627|183371365|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mediation using Sobel Test|||||||<0.001
91739628|NCT00120627|183371366|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
91739629|NCT00120627|183371367|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA||||< 0.05
91739630|NCT00120627|183371368|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Depression Subscale||||<0.001
91739631|NCT00120627|183371368|SUPERIORITY_OR_OTHER||||||=|0.31|TWO_SIDED||||||ANOVA|||Anxiety Subscale||||=0.31
91739632|NCT00120627|183371368|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||ANOVA|||Somatization Subscale||||=0.44
91739633|NCT00120627|183371369|SUPERIORITY_OR_OTHER||||||=|0.66|TWO_SIDED||||||ANOVA|||Post-hoc analysis||||=0.66
91739634|NCT00120627|183371370|SUPERIORITY_OR_OTHER||||||=|0.18|TWO_SIDED||||||ANOVA|||||||= 0.18
91739635|NCT00120627|183371371|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||< 0.01
91739636|NCT00959907|183371388|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||t-test, 2 sided|||||||0.832
91739637|NCT00959907|183371389|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||t-test, 2 sided|||||||0.658
91499375|NCT02282020|182868273|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.714|TWO_SIDED|95.0|0.76|1.49||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.49|0.76|0.714
91739638|NCT00959907|183371389|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||t-test, 2 sided|||||||0.739
91739639|NCT00959907|183371390|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||t-test, 2 sided|||||||0.184
91739640|NCT01722929|183371400|OTHER||||||<|0.0001||||||p-value is for the main effect for the Treatment, Time, and Treatment\*Time interaction.|Mixed Models Analysis|||A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.||||<0.0001
91739641|NCT04290624|183371485|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.20|-0.40|<0.0001
91739642|NCT04290624|183371486|SUPERIORITY||Mean Difference (Final Values)|-28.6|STANDARD_ERROR_OF_MEAN|4.73|<|0.0001|TWO_SIDED|95.0|-38.1|-19.1|||ANCOVA|||At Week 6||-19.1|-38.1|<0.0001
91739643|NCT04290624|183371486|SUPERIORITY||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|5.08|<|0.0001|TWO_SIDED|95.0|-38.2|-17.7|||ANCOVA|||At Week 12||-17.7|-38.2|<0.0001
91739644|NCT04290624|183371487|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||At Week 6||-0.27|-0.52|<0.0001
91739645|NCT04290624|183371487|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.47|-0.25|||ANCOVA|||At Week 12||-0.25|-0.47|<0.0001
91739646|NCT04290624|183371488|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.14|-0.56|||ANCOVA|||At Week 6||-0.56|-1.14|<0.0001
91739647|NCT04290624|183371488|SUPERIORITY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.139|<|0.0001|TWO_SIDED|95.0|-1.23|-0.67|||ANCOVA|||At Week 12||-0.67|-1.23|<0.0001
91739648|NCT04290624|183371489|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.151|<|0.0001|TWO_SIDED|95.0|-1.22|-0.61|||ANCOVA|||At Week 6||-0.61|-1.22|<0.0001
91739649|NCT04290624|183371489|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.36|-0.74|||ANCOVA|||At Week 12||-0.74|-1.36|<0.0001
91739650|NCT04290624|183371490|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.41|-0.23|||ANCOVA|||||-0.23|-0.41|<0.0001
91499376|NCT02282020|182868274|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.005|TWO_SIDED|95.0|0.41|0.85||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \<1 favours the olaparib arm|||0.85|0.41|0.005
91739651|NCT04290624|183371491|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0039|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||At Week 6||-0.2|-0.9|0.0039
91739652|NCT04290624|183371491|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|||At Week 12||-0.5|-1.1|<0.0001
91739653|NCT04290624|183371492|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0367|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA|||At Week 6||-0.01|-0.21|0.0367
91739654|NCT04290624|183371492|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.033||0.0725|TWO_SIDED|95.0|-0.14|-0.01|||Van-Elteren test|||At Week 12||-0.01|-0.14|0.0725
91739655|NCT04290624|183371493|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.075||0.0006|TWO_SIDED|95.0|-0.43|-0.13|||ANCOVA|||At Week 6||-0.13|-0.43|0.0006
91739656|NCT04290624|183371493|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.073||0.0009|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||At Week 12||-0.11|-0.41|0.0009
91739657|NCT04290624|183371494|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.117||0.002|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||At Week 6||-0.15|-0.62|0.0020
91739658|NCT04290624|183371494|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.52|-0.16|||ANCOVA|||At Week 12||-0.16|-0.52|0.0005
91739659|NCT00656370|183371511|SUPERIORITY|||||||0.93|||||||Wilcoxon signed rank test|||||||0.93
91739660|NCT00656370|183371512|SUPERIORITY|||||||0.67|||||||Wilcoxon signed rank test|||||||0.67
91739661|NCT01342094|183371517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||ANCOVA|||||-0.9|-2.2|< 0.001
91739662|NCT01646814|183371561|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
91739663|NCT01911351|183371566|SUPERIORITY_OR_OTHER||kappa statistic|0.88|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance: p\< or = 0.05|Chi-squared|||A kappa statistic was performed for 75% of the group to assess inter-rater agreement of the perception of the success of the procedure.||||<0.001
91739664|NCT01333436|183371590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.8|STANDARD_DEVIATION|36.8||0.0078||95.0|||||t-test, 2 sided|||||||0.0078
91739665|NCT01333436|183371591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.5|STANDARD_DEVIATION|13.9||0.0675||95.0|||||t-test, 2 sided|||||||0.0675
91739666|NCT01333436|183371592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|4.8||0.1798||95.0|||||t-test, 2 sided|||||||0.1798
91739667|NCT02878382|183371593|SUPERIORITY||||||<|0.001||||||significance level of 5%|Chi-squared|also, Fisher's exact test and Mann-Whtiney were used for comparing the other variables in the study||||||<0.001
91739668|NCT02878382|183371595|SUPERIORITY||||||=|0.001||||||significance level of 5%|Fisher Exact|||||||=0.001
91739669|NCT02878382|183371596|SUPERIORITY||||||=|0.048|||||||Wilcoxon (Mann-Whitney)|||Student's t-test or the Mann-Whitney test was used according to the assumption of normality of data for PpIX fluorescence intensity||||=0.048
91739670|NCT00543985|183371597|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.266|||=|0.14|TWO_SIDED|95.0|||||Regression, Linear|||Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.||||=0.14
91499377|NCT02282020|182868275|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.69||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.69|0.35|<0.001
91499378|NCT02282020|182868276|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.089|TWO_SIDED|95.0|0.53|1.05||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.05|0.53|0.089
91739671|NCT01634152|183371601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.032||0.2724|TWO_SIDED|95.0|-0.028|0.099|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.099|-0.028|0.2724
91739672|NCT01634152|183371601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.075|0.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.203|0.075|<0.0001
91739673|NCT01634152|183371602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.034||0.5898|TWO_SIDED|95.0|-0.048|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.085|-0.048|0.5898
91739674|NCT01634152|183371602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.034||0.0117|TWO_SIDED|95.0|0.019|0.154|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.154|0.019|0.0117
91739675|NCT01634152|183371603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.036||0.2277|TWO_SIDED|95.0|-0.113|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.027|-0.113|0.2277
91739676|NCT01634152|183371603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.036||0.3998|TWO_SIDED|95.0|-0.04|0.101|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.101|-0.040|0.3998
91739677|NCT01634152|183371604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.037||0.203|TWO_SIDED|95.0|-0.121|0.026|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.026|-0.121|0.2030
91739678|NCT01634152|183371604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.8194|TWO_SIDED|95.0|-0.066|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.066|0.8194
91739679|NCT01634152|183371605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031|STANDARD_ERROR_OF_MEAN|0.029||0.2907|TWO_SIDED|95.0|-0.026|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.088|-0.026|0.2907
91739680|NCT01634152|183371605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.068|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.184|0.068|<0.0001
91739681|NCT01634152|183371606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.032||0.2008|TWO_SIDED|95.0|-0.103|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.022|-0.103|0.2008
91739682|NCT01634152|183371606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.032||0.2545|TWO_SIDED|95.0|-0.026|0.1|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.100|-0.026|0.2545
91739683|NCT01634152|183371609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.078||0.798|TWO_SIDED|95.0|-0.133|0.173|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.173|-0.133|0.7980
91739684|NCT01634152|183371609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.079|STANDARD_ERROR_OF_MEAN|0.079||0.3166|TWO_SIDED|95.0|-0.233|0.076|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.076|-0.233|0.3166
91739685|NCT01634152|183371611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.124||0.8916|TWO_SIDED|95.0|-0.227|0.261|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.261|-0.227|0.8916
91739686|NCT01634152|183371611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.126||0.4789|TWO_SIDED|95.0|-0.336|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.158|-0.336|0.4789
91739687|NCT01634152|183371612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.074||0.8361|TWO_SIDED|95.0|-0.16|0.129|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.129|-0.160|0.8361
91739688|NCT01634152|183371612|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.087|STANDARD_ERROR_OF_MEAN|0.075||0.2461|TWO_SIDED|95.0|-0.233|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.060|-0.233|0.2461
91499379|NCT02282020|182868277|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.14|0.29||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.29|0.14|<0.001
91499380|NCT02282020|182868280|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.108|TWO_SIDED|95.0|-0.5|5.5|||Mixed Models Analysis|Model includes factors for patient, treatment, visit, treatment by visit interaction, baseline TOI score and baseline TOI score by visit interaction.||||5.5|-0.5|0.108
91499381|NCT02282020|182868281|SUPERIORITY||Odds Ratio (OR)|2.24||||0.092|TWO_SIDED|95.0|0.88|6.86||Estimated from an unadjusted logistic regression model|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||6.86|0.88|0.092
91499382|NCT02282020|182868282|SUPERIORITY||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.32|4.39||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||4.39|1.32|0.004
91499383|NCT02282020|182868283|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.014|TWO_SIDED|95.0|0.42|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.42|0.014
91499384|NCT02282020|182868284|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.213|TWO_SIDED|95.0|0.56|1.14||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.14|0.56|0.213
91739689|NCT01634152|183371613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.067||0.6029|TWO_SIDED|95.0|-0.096|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.165|-0.096|0.6029
91739690|NCT01634152|183371613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.067||0.7034|TWO_SIDED|95.0|-0.158|0.107|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.107|-0.158|0.7034
91739691|NCT01634152|183371614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.776|STANDARD_ERROR_OF_MEAN|4.686||0.3083|TWO_SIDED|95.0|-4.419|13.97|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||13.970|-4.419|0.3083
91739692|NCT01634152|183371614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.743|STANDARD_ERROR_OF_MEAN|4.747||0.3179|TWO_SIDED|95.0|-4.571|14.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||14.057|-4.571|0.3179
91739693|NCT01634152|183371615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.567|STANDARD_ERROR_OF_MEAN|4.807||0.9061|TWO_SIDED|95.0|-8.866|10.001|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||10.001|-8.866|0.9061
91499385|NCT02282020|182868285|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.699|TWO_SIDED|95.0|0.76|1.51||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.51|0.76|0.699
91739694|NCT01634152|183371615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.107|STANDARD_ERROR_OF_MEAN|4.867||0.399|TWO_SIDED|95.0|-13.658|5.444|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||5.444|-13.658|0.3990
91739695|NCT01634152|183371616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.025||0.3542|TWO_SIDED|95.0|-2.959|1.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||1.060|-2.959|0.3542
91739696|NCT01634152|183371616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.502|STANDARD_ERROR_OF_MEAN|1.042||0.6298|TWO_SIDED|95.0|-2.545|1.541|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||1.541|-2.545|0.6298
91739697|NCT01634152|183371617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.038||0.4066|TWO_SIDED|95.0|-0.107|0.043|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.043|-0.107|0.4066
91739698|NCT01634152|183371617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049|STANDARD_ERROR_OF_MEAN|0.039||0.2032|TWO_SIDED|95.0|-0.125|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.027|-0.125|0.2032
91739699|NCT01634152|183371618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.041||0.2064|TWO_SIDED|95.0|-0.131|0.028|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.028|-0.131|0.2064
91739700|NCT01634152|183371618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.041||0.141|TWO_SIDED|95.0|-0.142|0.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.020|-0.142|0.1410
91739701|NCT01634152|183371619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.042||0.9869|TWO_SIDED|95.0|-0.083|0.082|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.082|-0.083|0.9869
91705201|NCT05153148|183304906|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.014|TWO_SIDED|95.0|3.3|29.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.3|3.3|=0.014
91705202|NCT05153148|183304907|SUPERIORITY||Treatment Difference|-3.73|||=|0.167|TWO_SIDED|95.0|-9.04|1.57|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.57|-9.04|=0.167
91739702|NCT01634152|183371619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.043||0.873|TWO_SIDED|95.0|-0.077|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.077|0.8730
91499386|NCT02282020|182868286|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.12|0.27||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.27|0.12|<0.001
91499387|NCT02282020|182868287|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.66||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.66|0.33|<0.001
91499388|NCT02282020|182868288|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.055|TWO_SIDED|95.0|0.51|1.01||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.01|0.51|0.055
91499389|NCT02328755|182868317|OTHER|Single group|cumulative incidence|0.39|||||TWO_SIDED|95.0|0.24|0.58||||||The analysis applies only to the first row, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).||0.58|0.24|
91499390|NCT02328755|182868318|OTHER|Single group|Kaplan-Meier|55.0|||||TWO_SIDED|95.0|40.0|75.0||||||The analysis applies only to the first row, data at 6 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|75|40|
91499391|NCT02328755|182868318|OTHER|Single group|Kaplan-Meier|33.0|||||TWO_SIDED|95.0|19.0|58.0||||||The analysis applies only to the 3rd row, data at 24 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|58|19|
91499392|NCT02328755|182868319|OTHER|Single group|||||||||||||||||Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|||
91499393|NCT02328755|182868320|OTHER|Single group|||||||||||||||||GVHD proportion estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
91739703|NCT01634152|183371620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.006|STANDARD_ERROR_OF_MEAN|0.049||0.9043|TWO_SIDED|95.0|-0.103|0.091|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.091|-0.103|0.9043
91739704|NCT01634152|183371620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.05||0.7708|TWO_SIDED|95.0|-0.112|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.112|0.7708
91739705|NCT01634152|183371621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.4864|TWO_SIDED|95.0|-0.139|0.066|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.066|-0.139|0.4864
91739706|NCT01634152|183371621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.053||0.7991|TWO_SIDED|95.0|-0.117|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.117|0.7991
91739707|NCT01634152|183371622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.05||0.8884|TWO_SIDED|95.0|-0.092|0.106|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.106|-0.092|0.8884
91739708|NCT01634152|183371622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.051||0.8115|TWO_SIDED|95.0|-0.112|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.088|-0.112|0.8115
91739709|NCT01634152|183371623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.051||0.7498|TWO_SIDED|95.0|-0.084|0.117|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.117|-0.084|0.7498
91739710|NCT01634152|183371623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|STANDARD_ERROR_OF_MEAN|0.052||0.1108|TWO_SIDED|95.0|-0.185|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.019|-0.185|0.1108
91739711|NCT01634152|183371624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.059||0.8055|TWO_SIDED|95.0|-0.131|0.102|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.102|-0.131|0.8055
91739712|NCT01634152|183371624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.071|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.189|0.047|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.047|-0.189|0.2360
91739713|NCT01634152|183371625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|STANDARD_ERROR_OF_MEAN|0.041||0.6748|TWO_SIDED|95.0|-0.097|0.063|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.063|-0.097|0.6748
91739714|NCT01634152|183371625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025|STANDARD_ERROR_OF_MEAN|0.041||0.5497|TWO_SIDED|95.0|-0.056|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.105|-0.056|0.5497
91739715|NCT03848455|183371626|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP2CA gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
91739716|NCT03848455|183371626|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of SYNJ1 gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
91739717|NCT03848455|183371626|OTHER|||||||0.149|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP3CB gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||0.149
91499394|NCT02328755|182868321|OTHER|Single group|||||||||||||||||Non-relapse mortality estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
91499395|NCT05081011|182868367|OTHER|||||||0.006||||||A p-value of 0.05 would be considered statistically significant|Log Rank|||||||0.006
91499396|NCT05081011|182868368|OTHER||Mean Difference (Final Values)|32.7||||0.01|TWO_SIDED|95.0|8.0|57.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||57.4|8.0|0.01
91499397|NCT05081011|182868369|OTHER||Mean Difference (Final Values)|-3.6||||0.03|TWO_SIDED|95.0|-6.8|-0.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||-0.4|-6.8|0.03
91499398|NCT05081011|182868370|OTHER||Mean Difference (Final Values)|1.4||||0.06|TWO_SIDED|95.0|-0.03|2.8|||Welch 2-sample method|||||2.8|-0.03|0.06
91499399|NCT05081011|182868371|OTHER||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-1.6|3.5|||Welch 2-sample method|||||3.5|-1.6|0.46
91499400|NCT05081011|182868372|OTHER||Mean Difference (Final Values)|0.56||||0.005|TWO_SIDED|95.0|0.21|0.91|||2-sample test|2-sample test for equality of proportions with Yates continuity correction|Comparison of percentage (proportion) of participants achieving glycemic control.|Comparison of percentage (proportion) of participants achieving glycemic control.||0.91|0.21|0.005
91499401|NCT05081011|182868373|OTHER||Mean Difference (Final Values)|-68.9||||0.001|TWO_SIDED|95.0|-107.1|-30.1|||Welch 2-sample method|||||-30.1|-107.1|0.001
91499402|NCT00558025|182868375|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: -15 %, power: 80%|Risk Difference (RD)|-10.75||||||95.0|-20.51|1.48|||Wilson score interval|||Successfully switched patients||1.48|-20.51|
91499403|NCT00558025|182868375|SUPERIORITY_OR_OTHER|||||||0.0803||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.0803
91760083|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.47|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.47|
91499404|NCT00558025|182868376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2061||95.0|-2.8|0.6|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.6|-2.8|0.2061
91499405|NCT00558025|182868377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4694||95.0|-0.8|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-0.8|0.4694
91499406|NCT00558025|182868378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.1804||95.0|-2.3|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-2.3|0.1804
91499407|NCT00558025|182868379|SUPERIORITY_OR_OTHER|||||||0.1623|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1623
91499408|NCT00558025|182868380|SUPERIORITY_OR_OTHER|||||||0.1299|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1299
91760084|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|0.22|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|0.22|
91760085|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.18|0.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|-0.18|
91760086|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.55|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.55|
91760087|NCT01393639|183411994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.47|0.49||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.49|-0.47|
91760088|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.76|0.03||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.76|
91760089|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.17|
91760090|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-1.32|-0.54||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.32|
91760091|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.17|||||TWO_SIDED|95.0|-1.56|-0.78||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.78|-1.56|
91760092|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.09||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-0.70|
91760093|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.34|-0.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.55|-1.34|
91760094|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.84|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.84|
91760095|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.23|-0.32||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.32|-1.23|
91760096|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.52|-0.61||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.61|-1.52|
91760097|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.45|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.45|
91499409|NCT00558025|182868381|SUPERIORITY_OR_OTHER|||||||0.619||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.6190
91499410|NCT01506479|182868383|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.0001|TWO_SIDED|95.0|12.0|16.6|||t-test, 2 sided|||||16.6|12.0|<0.0001
91499411|NCT01506479|182868384|OTHER||Mean Difference (Final Values)|2.9||||0.34|ONE_SIDED|90.0||4.6||The a priori threshold for statistical significance was 0.10|t-test, 1 sided|||The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.||4.6||0.34
91531110|NCT01254565|182938562|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-36.7||||0.0032|TWO_SIDED|95.0|-59.8|-13.6|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-13.6|-59.8|0.0032
91499412|NCT01506479|182868384|OTHER||Mean Difference (Final Values)|1.2||||0.03|ONE_SIDED|90.0||2.8||The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).|t-test, 1 sided||"The estimate is the difference between the control group and the moderate exercise group.~The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis."|The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .||2.8||0.03
91531111|NCT01254565|182938563|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91499413|NCT01506479|182868385|SUPERIORITY|||||||0.1334|||||||t-test, 2 sided|||||||0.1334
91739718|NCT03848455|183371626|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of NSF gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
91739719|NCT01900665|183371638|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.095|TWO_SIDED|95.0|-1.73|0.14|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||||0.14|-1.73|0.095
91739720|NCT02481258|183371656|EQUIVALENCE|Power calculations were based on a two-sample t-test. A priori calculations to detect an effect size of 0.57 units indicated that that 50 patients per arm were needed to have 80% power. The actual effect size observed in the present study was 0.86.||||||0.05|||||||ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||0.05
91739721|NCT02481258|183371658|EQUIVALENCE|Power calculations were based on a two-sample t-tests assuming initial recruitment of 50 subjects.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||||||>0.05
91739722|NCT02481258|183371659|EQUIVALENCE|Power calculations were based on a two-sample t-test.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||>0.05
91739723|NCT02317627|183371670|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
91499414|NCT03315208|182868432|SUPERIORITY||Chi-squared statistic value|0.23||||0.63|TWO_SIDED||||||Chi-squared, Corrected|df=1||||||0.63
91531112|NCT01254565|182938563|SUPERIORITY|||||||0.0968|||||||Fisher Exact|||||||0.0968
91531113|NCT01254565|182938564|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91531114|NCT01254565|182938564|SUPERIORITY|||||||0.073|||||||Fisher Exact|||||||0.0730
91739724|NCT02317627|183371670|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0035||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0035
91531115|NCT01254565|182938565|SUPERIORITY||LS Mean Difference|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.4|-8.4|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-8.4|-16.4|< 0.0001
91739725|NCT02317627|183371670|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0261||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0261
91739726|NCT02317627|183371670|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change for all subjects' PASI from baseline to Week 12.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
91739727|NCT02317627|183371671|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
91739728|NCT02317627|183371671|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0029
91499415|NCT03315208|182868433|SUPERIORITY||Slope|0.72||||0.29|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.29
91499416|NCT03315208|182868434|SUPERIORITY||Slope|-0.56||||0.5|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.50
91513588|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-7.1|-3.0||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-3.0|-7.1|< 0.001
91739729|NCT02317627|183371671|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0703||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0703
91739730|NCT02317627|183371671|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects' PASI from baseline to Week 12.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
91739731|NCT02317627|183371676|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 4.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
91739732|NCT02317627|183371676|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 4.||||||0.0479||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0479
91739733|NCT02317627|183371676|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 4.||||||0.1513||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.1513
91739734|NCT02317627|183371676|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 4.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
91739735|NCT02317627|183371677|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 8.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
91739736|NCT02317627|183371677|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 8.||||||0.0017||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0017
91739737|NCT02317627|183371677|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 8.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
91739738|NCT02317627|183371677|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 8.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
91739739|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 4 weeks.||||||0.014||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0140
91531116|NCT01254565|182938565|SUPERIORITY||LS Mean Difference|-6.9||||0.0235|TWO_SIDED|95.0|-12.8|-1.0|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.0|-12.8|0.0235
91531117|NCT01254565|182938566|SUPERIORITY||LS Mean Difference|-4.2||||0.2255|TWO_SIDED|95.0|-18.6|5.7|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.7|-18.6|0.2255
91739740|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 4 weeks.||||||0.062||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0620
91739741|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in 400 mg BID from baseline to 4 weeks.||||||0.262||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.2620
91499417|NCT03315208|182868435|SUPERIORITY||Slope|-1.96||||0.45|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. BSI scores were binarized (0 and \>=1) for this analysis due to the non-normal distribution of this outcome.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.45
91499418|NCT03315208|182868437|SUPERIORITY||Slope|-0.19||||0.76|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.76
91499419|NCT03315208|182868438|SUPERIORITY||Slope|-1.07||||0.21|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. Due to the non-normal distribution of the Craving Scale, scores on this measure were binarized (\< 15 and \>= 15) for this analysis.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.21
91513589|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-6.6|-0.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.3|-6.6|< 0.001
91739742|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 4 weeks.||||||0.0008||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0008
91739743|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 8 weeks.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
91739744|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 8 weeks.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
91739745|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 8 weeks.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
91739746|NCT02317627|183371678|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 8 weeks.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
91739747|NCT02317627|183371683|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 12 weeks.||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
91739748|NCT02317627|183371683|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 12 weeks.||||||0.007||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.007
91739749|NCT02317627|183371683|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 12 weeks.||||||0.09||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.090
91739750|NCT02317627|183371683|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to 12 weeks.|||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
91739751|NCT02317627|183371684|SUPERIORITY|||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
91739752|NCT02317627|183371684|SUPERIORITY|||||||0.029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.029
91739753|NCT02317627|183371684|SUPERIORITY|||||||0.084||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.084
91499420|NCT03315208|182868439|SUPERIORITY||t statistic|0.29||||0.77|TWO_SIDED||||||t-test, 2 sided|||Due to the non-normal distribution of the PDA variable, this variable was treated as binary (\<50% and \>=50%) for mixed models; however, due to the small numbers of participants (\< 5) in certain cells of treatment condition (UP versus TAU) by time point, we ran into issues with convergence of linear mixed models. Thus, here we report the results from an independent samples t-test of means (percentage of past 30 days abstinent) at post-treatment (UP versus TAU).||||0.77
91499421|NCT02746874|182868440|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
91499422|NCT02746874|182868442|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
91499423|NCT02746874|182868443|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||.371
91499424|NCT02746874|182868444|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||||||.325
91499425|NCT02746874|182868445|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||.466
91499426|NCT02746874|182868446|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||.368
91499427|NCT02746874|182868447|SUPERIORITY|||||||0.509|||||||Wilcoxon (Mann-Whitney)|||||||.509
91531118|NCT01254565|182938566|SUPERIORITY||LS mean Difference|-21.8||||0.1751|TWO_SIDED|95.0|-29.8|5.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.9|-29.8|0.1751
91739754|NCT02317627|183371684|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
91739755|NCT00279214|183371689|SUPERIORITY_OR_OTHER|||||||0.238||95.0|||||Repeated Measures - propensity adjusted|||24-Hour p-value||||0.238
91499428|NCT02746874|182868448|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||.593
91499429|NCT02746874|182868449|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||0.687
91499430|NCT02746874|182868450|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
91739756|NCT00279214|183371689|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.281
91499431|NCT02746874|182868451|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||.687
91499432|NCT02746874|182868452|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.840
91499433|NCT02746874|182868453|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||||||.913
91739757|NCT00279214|183371690|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||P-value for 96 Hour Change from Baseline.|Mixed Models Analysis|Model: Outcome=Therapy + Sedative Indicator + Time + Therapy\*Time + Propensity Score||||||0.478
91499434|NCT02746874|182868454|SUPERIORITY|||||||0.301|||||||Wilcoxon (Mann-Whitney)|||||||0.301
91499435|NCT02746874|182868455|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
91499436|NCT02746874|182868456|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
91499437|NCT02746874|182868458|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||.047
91499438|NCT02746874|182868459|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||||||.115
91499439|NCT02746874|182868460|SUPERIORITY|||||||0.349|||||||Wilcoxon (Mann-Whitney)|||||||.349
91531119|NCT01254565|182938567|SUPERIORITY||LS Mean Difference|-11.2||||0.0112|TWO_SIDED|95.0|-26.8|-4.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-4.9|-26.8|0.0112
91531120|NCT01254565|182938567|SUPERIORITY||LS Mean Difference|-27.7||||0.0554|TWO_SIDED|95.0|-39.3|-1.6|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.6|-39.3|0.0554
91499440|NCT01156311|182868472|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.17|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.17|<0.0001
91499441|NCT01156311|182868472|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.17||||0.0124|TWO_SIDED|95.0|-1.83|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.83|0.0124
91499442|NCT01156311|182868473|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-1.5|-0.25|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||-0.25|-1.50|0.0010
91499443|NCT01156311|182868473|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.0339|TWO_SIDED|95.0|-1.25|0.0|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||0.00|-1.25|0.0339
91499444|NCT06133348|182868480|OTHER|Single group|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.9||0.0089|TWO_SIDED|95.0|0.9|5.8|||Paired t-Test|||||5.8|0.9|0.0089
91499445|NCT06133348|182868481|OTHER|Single group|Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|23.8||0.0169|TWO_SIDED|95.0|2.0|18.8|||Paired t-Test|||||18.8|2|0.0169
91499446|NCT06133348|182868482|OTHER|Single group|Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|5.3||0.0162|TWO_SIDED|95.0|0.5|4.3|||Paired t-Test|||||4.3|0.5|0.0162
91499447|NCT06133348|182868483|OTHER|Single group|Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|7.6||0.0144|TWO_SIDED|95.0|0.7|6.1|||Paired t-Test|||||6.1|0.7|0.0144
91499448|NCT06133348|182868484|OTHER|Single group|Mean Difference (Final Values)|2.9|STANDARD_DEVIATION|7.3||0.0264|TWO_SIDED|95.0|0.4|5.5|||Paired t-Test|||||5.5|0.4|0.0264
91499449|NCT06133348|182868485|OTHER|Single group|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.7||0.1622|TWO_SIDED|95.0|-0.3|1.6|||Paired t-Test|||||1.6|-0.3|0.1622
91499450|NCT06133348|182868486|OTHER|Single group|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|4.0||0.1506|TWO_SIDED|95.0|-0.4|2.5|||Paired t-Test|||||2.5|-0.4|0.1506
91739758|NCT00279214|183371691|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.442
91739759|NCT00279214|183371691|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.871
91739760|NCT00279214|183371692|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.704
91739761|NCT00279214|183371692|SUPERIORITY_OR_OTHER|||||||0.702||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.702
91739762|NCT00279214|183371693|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||6-Hour p-value|Repeated Measures - propensity adjusted|||||||0.061
91739763|NCT00279214|183371693|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||6-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.027
91499451|NCT06133348|182868487|OTHER|Single group|Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|5.5||0.0012|TWO_SIDED|95.0|1.5|5.4|||Paired t-Test|||||5.4|1.5|0.0012
91499452|NCT06133348|182868488|OTHER|Single group|Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|2.1||0.0021|TWO_SIDED|95.0|0.5|2.0|||Paired t-Test|||||2|0.5|0.0021
91499453|NCT06133348|182868489|OTHER|Single group|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.6||0.0027|TWO_SIDED|95.0|0.6|2.4|||Paired t-Test|||||2.4|0.6|0.0027
91531121|NCT03123263|182938631|OTHER|Repeated measures one sided ANOVA was used to analyze changes in ejection fraction over time.|||||<|0.0005|||||||ANOVA|F (2,98) =13.974||||||<0.0005
91739764|NCT00279214|183371694|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.242
91739765|NCT00279214|183371694|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.083
91739766|NCT00279214|183371694|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.810
91739767|NCT00279214|183371694|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.623
91739768|NCT00279214|183371695|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.686
91739769|NCT00279214|183371695|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.575
91739770|NCT00279214|183371696|SUPERIORITY_OR_OTHER|||||||0.165||95.0|||||Repeated Measures - propensity adjusted|||||||0.165
91739771|NCT00279214|183371698|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.552
91739772|NCT00279214|183371698|SUPERIORITY_OR_OTHER|||||||0.129||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.129
91739773|NCT00279214|183371698|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.030
91739774|NCT00279214|183371698|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.002
91499454|NCT06133348|182868490|OTHER|Single group|Mean Difference (Final Values)|0.697|STANDARD_DEVIATION|2.0||0.0494|TWO_SIDED|95.0|0.0|1.4|||Paired t-Test|||||1.4|0.0|0.0494
91499455|NCT06133348|182868491|OTHER|Single group|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|4.8||0.4707|TWO_SIDED|95.0|-1.1|2.3|||Paired t-Test|||||2.3|-1.1|0.4707
91499456|NCT06133348|182868492|OTHER|Single group|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|5.1||0.0082|TWO_SIDED|95.0|-4.3|-0.7|||Paired t-Test|||||-0.7|-4.3|0.0082
91499457|NCT06133348|182868493|OTHER|Single group|Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|4.3||0.1327|TWO_SIDED|95.0|-2.7|0.4|||Paired t-Test|||||0.4|-2.7|0.1327
91499458|NCT06133348|182868494|OTHER|Single group|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|5.0||0.2046|TWO_SIDED|95.0|-2.9|0.6|||Paired t-Test|||||0.6|-2.9|0.2046
91499459|NCT06133348|182868495|OTHER|Single group|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|5.9||0.5252|TWO_SIDED|95.0|-2.8|1.4|||Paired t-Test|||||1.4|-2.8|0.5252
91499460|NCT06133348|182868496|OTHER|Single group|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|6.0||0.4569|TWO_SIDED|95.0|-1.3|2.9|||Paired t-Test|||||2.9|-1.3|0.4569
91499461|NCT06133348|182868497|OTHER|Single group|Mean Difference (Final Values)|12.2|STANDARD_DEVIATION|40.8||0.1497|TWO_SIDED|95.0|-4.7|29.0|||Paired t-Test|||||29.0|-4.7|0.1497
91531122|NCT02971891|182938691|SUPERIORITY|||||||0.1789|||||||Cochran-Mantel-Haenszel|||||||0.1789
91739775|NCT00279214|183371700|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.128
91739776|NCT00279214|183371700|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.234
91739777|NCT01475721|183371752|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.029||||0.003|TWO_SIDED|95.0|0.638|1.662|||Regression, Cox|||||1.662|0.638|0.003
91739778|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.834||||0.203|TWO_SIDED|95.0|0.63|1.103|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy.|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.103|0.630|0.203
91739779|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.188|TWO_SIDED|95.0|0.645|1.09|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.090|0.645|0.188
91739780|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.002|TWO_SIDED|95.0|0.645|0.905|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.905|0.645|0.002
91739781|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.071|TWO_SIDED|95.0|0.451|1.034|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.034|0.451|0.071
91739782|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.373|TWO_SIDED|95.0|0.659|1.17|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.170|0.659|0.373
91739783|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.271|TWO_SIDED|95.0|0.665|1.122|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.122|0.665|0.271
91499462|NCT06133348|182868498|OTHER|Single group|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|65.5||0.2163|TWO_SIDED|95.0|-10.4|43.7|||Paired t-Test|||||43.7|-10.4|0.2163
91499463|NCT06133348|182868499|OTHER|Single group|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|10.1||0.0915|TWO_SIDED|95.0|-0.6|7.7|||Paired t-Test|||||7.7|-0.6|0.0915
91499464|NCT06133348|182868500|OTHER|Single group|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|28.1||0.3573|TWO_SIDED|95.0|-6.3|16.9|||Paired t-Test|||||16.9|-6.3|0.3573
91739784|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.001|TWO_SIDED|95.0|0.637|0.895|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.895|0.637|0.001
91739785|NCT01475721|183371753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.075|TWO_SIDED|95.0|0.454|1.04|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.040|0.454|0.075
91739786|NCT01475721|183371755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776||||0.123|TWO_SIDED|95.0|0.562|1.071|||Regression, Cox|||||1.071|0.562|0.123
91739787|NCT01475721|183371756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||<|0.001|TWO_SIDED|95.0|-0.385|-0.141|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|||-0.141|-0.385|<0.001
91739788|NCT01475721|183371756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222||||0.003|TWO_SIDED|95.0|-0.369|-0.076|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|||-0.076|-0.369|0.003
91739789|NCT01475721|183371756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||<|0.001|TWO_SIDED|95.0|-0.238|-0.106|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|||-0.106|-0.238|<0.001
91739790|NCT01475721|183371756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.251|TWO_SIDED|95.0|-0.216|0.056|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS therapy|||0.056|-0.216|0.251
91739791|NCT01772550|183371762|NON_INFERIORITY_OR_EQUIVALENCE|A 95% upper confidence bound for the observed difference in percentages of images with acceptable quality between the control catheter and evaluation catheter was calculated using the Score method. The 20 G BD Nexiva™ Diffusics™ can be considered non-inferior for acceptable image quality if this 95% upper confidence bound is smaller than 15% (i.e. C - D \< 15% with 95% confidence). The non-inferiority margin was 15%.|Risk Difference (RD)|0.0|||||ONE_SIDED|95.0||2.6|||||The difference in percent of acceptable image quality is used as an estimate. The Score method was used to estimate the upper 95% confidence limit.|Only the percent of acceptable image quality from the randomized test and reference catheter groups were considered for this statistical analysis. If C is the percentage of acceptable quality images with the control catheter, and D is the percentage of images of acceptable quality with the evaluation catheter, and the non-inferiority criteria is 15%, the hypotheses to be tested are as follows: H0: C - D \> or = 15%; H1: C - D \< 15%.||2.6||
91739792|NCT00559104|183371776|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.51||||0.51|TWO_SIDED|95.0|0.07|3.79|||Regression, Cox||"Parameter Dispersion Type: Standard Error of the Parameter Estimate, not of the mean.~Standard Error = 1.02475"|There is no power calculation as this is a phase II study. This is an Event-free Survival, in which an event can be Relapse/Progression, or Death. Censoring can be at the End of follow-up date, or at the End of study date.||3.79|0.07|0.51
91499465|NCT06133348|182868501|OTHER|Single group|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|4.7||0.3741|TWO_SIDED|95.0|-2.8|1.1|||Paired t-Test|||||1.1|-2.8|0.3741
91499466|NCT06133348|182868502|OTHER|Single group|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.6187|TWO_SIDED|95.0|-0.6|1.0|||Paired t-Test|||||1.0|-0.6|0.6187
91499467|NCT06133348|182868503|OTHER|Single group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.2||0.3572|TWO_SIDED|95.0|-0.04|0.1|||Paired t-Test|||||0.1|-0.04|0.3572
91499468|NCT06133348|182868504|OTHER|Single group|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.8||0.108|TWO_SIDED|95.0|-0.5|4.3|||Paired t-Test|||||4.3|-0.5|0.1080
91739793|NCT00559104|183371777|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66||||0.69|TWO_SIDED|95.0|0.09|4.99|||Regression, Cox||"Numerator: Carmustine in the conditioning. Denominator: Irradiation in the conditioning.~Parameter: Hazard ratio. Dispersion: Standard Error of the Hazard Ratio."|Phase II analysis: There was no power calculation.||4.99|0.09|0.69
91739794|NCT01815424|183371779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.52|||<|0.0001|TWO_SIDED|95.0|6.03|32.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||32.77|6.03|<0.0001
91739795|NCT01815424|183371779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.46|11.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||11.86|2.46|<0.0001
91739796|NCT01815424|183371780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.71|||<|0.0001|TWO_SIDED|95.0|14.84|151.11||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||151.11|14.84|<0.0001
91739797|NCT01815424|183371780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.97|||<|0.0001|TWO_SIDED|95.0|4.06|25.17||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||25.17|4.06|<0.0001
91739798|NCT01815424|183371781|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|8.461|<|0.0001|TWO_SIDED|95.0|-88.2|-54.87||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-54.87|-88.20|<0.0001
91499469|NCT06133348|182868505|OTHER|Single group|Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|3.7||0.2088|TWO_SIDED|95.0|-0.6|2.5|||Paired t-Test|||||2.5|-0.6|0.2088
91531123|NCT01196104|182938710|NON_INFERIORITY_OR_EQUIVALENCE|Study terminated early due to business reasons, results are not properly powered.|Mean Difference (Final Values)|-0.0473|STANDARD_ERROR_OF_MEAN|0.2158||0.8283|TWO_SIDED|95.0|-0.4901|0.3956|||ANCOVA|||ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate||0.3956|-0.4901|0.8283
91499470|NCT06133348|182868508|OTHER|Single group|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.4||0.7333|TWO_SIDED|95.0|-0.1|0.2|||Paired t-Test|||||0.2|-0.1|0.7333
91499471|NCT06133348|182868509|OTHER|Single group|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.5||0.6382|TWO_SIDED|95.0|-0.8|1.3|||Paired t-Test|||||1.3|-0.8|0.6382
91499472|NCT06133348|182868510|OTHER|Single group|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|1.4||0.4771|TWO_SIDED|95.0|-0.8|0.4|||Paired t-Test|||||0.4|-0.8|0.4771
91739799|NCT01815424|183371781|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-52.12|STANDARD_ERROR_OF_MEAN|8.416|<|0.0001|TWO_SIDED|95.0|-68.7|-35.55||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-35.55|-68.70|<0.0001
91739800|NCT01815424|183371782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|70.31|||<|0.0001|TWO_SIDED|95.0|13.38|267.15||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||267.15|13.38|<0.0001
91739801|NCT01815424|183371782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.44|||<|0.0001|TWO_SIDED|95.0|4.31|79.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||79.62|4.31|<0.0001
91739802|NCT01815424|183371783|SUPERIORITY_OR_OTHER||Least square mean difference|-7.52|STANDARD_ERROR_OF_MEAN|0.913|<|0.0001|TWO_SIDED|95.0|-9.32|5.72||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||5.72|-9.32|<0.0001
91739803|NCT01815424|183371783|SUPERIORITY_OR_OTHER||Least square mean difference|-5.45|STANDARD_ERROR_OF_MEAN|0.907|<|0.0001|TWO_SIDED|95.0|-7.24|-3.67||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.67|-7.24|<0.0001
91739804|NCT01815424|183371784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.4|||<|0.0001|TWO_SIDED|95.0|8.95|2657.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.||2657.62|8.95|<0.0001
91739805|NCT01815424|183371784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.37|||<|0.0001|TWO_SIDED|95.0|3.47|1084.02||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||1084.02|3.47|<0.0001
91759511|NCT02391363|183411762|SUPERIORITY|||||||0.35||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.35
91499473|NCT00345254|182868538|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91499474|NCT02663232|182868569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage (IIIC \[referral category\] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.001
91499475|NCT02663232|182868569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIC/M1a/M1b \[referral category\] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.196
91499476|NCT02663232|182868569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||||0.002
91499477|NCT02663232|182868569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.716||||0.028|TWO_SIDED|95.0|1.115|6.616|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||6.616|1.115|0.028
91531124|NCT00065468|182938751|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.78||||0.0252|TWO_SIDED|95.0|0.63|0.97|||Log Rank|Stratified by prior nephrectomy and region||||0.97|0.63|0.0252
91739806|NCT01815424|183371785|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||<0.0001
91739807|NCT01815424|183371785|SUPERIORITY_OR_OTHER|||||||0.0386||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||0.0386
91739808|NCT01815424|183371786|SUPERIORITY_OR_OTHER||Least square mean difference|-5.09|STANDARD_ERROR_OF_MEAN|0.709|<|0.0001|TWO_SIDED|95.0|-6.49|-3.7||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.70|-6.49|<0.0001
91739809|NCT01815424|183371786|SUPERIORITY_OR_OTHER||Least square mean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|-5.59|-2.81||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-2.81|-5.59|<0.0001
91739810|NCT01815424|183371787|SUPERIORITY_OR_OTHER||Least square mean of difference|-41.23|STANDARD_ERROR_OF_MEAN|15.977||0.0113|TWO_SIDED|95.0|-72.91|-9.54||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-9.54|-72.91|0.0113
91739811|NCT01815424|183371787|SUPERIORITY_OR_OTHER||Least square mean of difference|-22.89|STANDARD_ERROR_OF_MEAN|16.01||0.1558|TWO_SIDED|95.0|-54.64|8.86||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||8.86|-54.64|0.1558
91760098|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.71|0.21||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-0.71|
91499478|NCT02663232|182868569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.466||||0.142|TWO_SIDED|95.0|0.168|1.291|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.291|0.168|0.142
91499479|NCT02663232|182868569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.653|TWO_SIDED|95.0|0.351|1.928|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.928|0.351|0.653
91499480|NCT02663232|182868570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.240
91499481|NCT02663232|182868571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.719|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.719
91531125|NCT00065468|182938751|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.93||||0.4902|TWO_SIDED|95.0|0.75|1.15|||Log Rank|Stratified by prior nephrectomy and region||||1.15|0.75|0.4902
91739812|NCT04723355|183371833|NON_INFERIORITY|In the sample size calculations, we assumed that the innovative 3-lead wireless water resistant Holter System would have a concordance in the diagnosis of arrhythmia compared to the conventional Holter device similar to a previous study that compared a patch to the conventional Holter device. With this assumption, a total sample of 182 participants would have 80% power to demonstrate an accuracy of at least 85% with a significance level of 2.5% (the 95% CI lower limit should be above 85%).|Accuracy|0.87|||||TWO_SIDED|95.0|0.81|0.92||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.92|0.81|
91739813|NCT04723355|183371833|OTHER||Sensitivity|0.9|||||TWO_SIDED|95.0|0.83|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.83|
91739814|NCT04723355|183371833|OTHER||Specificity|0.83|||||TWO_SIDED|95.0|0.72|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.72|
91499482|NCT02663232|182868572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of primary tumor site (trunk \[referral category\] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.262
91531126|NCT00065468|182938752|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.74||||0.0042|TWO_SIDED|95.0|0.6|0.91|||Log Rank|Stratified by prior nephrectomy and region||||0.91|0.60|0.0042
91739815|NCT04723355|183371833|OTHER||Positive predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
91739816|NCT04723355|183371833|OTHER||Negative predictive value|0.86|||||TWO_SIDED|95.0|0.76|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.76|
91739817|NCT04723355|183371833|OTHER||Cohen Kappa coefficient|0.74|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739818|NCT04723355|183371833|OTHER||Positive likelihood ratio|5.21|||||TWO_SIDED|95.0|3.17|8.58||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||8.58|3.17|
91739819|NCT04723355|183371833|OTHER||Negative likelihood ratio|0.12|||||TWO_SIDED|95.0|0.06|0.21||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.21|0.06|
91739820|NCT04723355|183371834|OTHER||Accuracy|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.97|
91739821|NCT04723355|183371834|OTHER||Sensitivity|1.0|||||TWO_SIDED|95.0|0.85|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.85|
91739822|NCT04723355|183371834|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
91739823|NCT04723355|183371834|OTHER||Positive predictive value|0.96|||||TWO_SIDED|95.0|0.78|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.78|
91739824|NCT04723355|183371834|OTHER||Negative predictive value|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
91739825|NCT04723355|183371834|OTHER||Cohen Kappa coefficient|0.97|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739826|NCT04723355|183371834|OTHER||Positive likelihood ratio|157.0|||||TWO_SIDED|95.0|22.25|1107.61||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1107.61|22.25|
91739827|NCT04723355|183371834|OTHER||Negative likelihood ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0|0|
91739828|NCT04723355|183371835|OTHER||Accuracy|0.85|||||TWO_SIDED|95.0|0.79|0.9||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.90|0.79|
91739829|NCT04723355|183371835|OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
91739830|NCT04723355|183371835|OTHER||Specificity|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
91499483|NCT02663232|182868573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of LDH (elevated \[referral category\] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.313
91499484|NCT02663232|182868574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.291
91499485|NCT02663232|182868575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample source (primary tumor \[referral category\] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.164
91739831|NCT04723355|183371835|OTHER||Positive predictive value|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
91739832|NCT04723355|183371835|OTHER||Negative predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
91739833|NCT04723355|183371835|OTHER||Cohen Kappa coefficient|0.7|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739834|NCT04723355|183371835|OTHER||Positive likelihood ratio|6.79|||||TWO_SIDED|95.0|4.03|11.43||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||11.43|4.03|
91739835|NCT04723355|183371835|OTHER||Negative likelihood ratio|0.21|||||TWO_SIDED|95.0|0.13|0.34||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.34|0.13|
91739836|NCT04723355|183371836|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.88|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.88|
91739837|NCT04723355|183371836|OTHER||Sensitivity|0.78|||||TWO_SIDED|95.0|0.56|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.56|
91739838|NCT04723355|183371836|OTHER||Specificity|0.95|||||TWO_SIDED|95.0|0.9|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.90|
91739839|NCT04723355|183371836|OTHER||Positive predictive value|0.69|||||TWO_SIDED|95.0|0.48|0.86||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.86|0.48|
91739840|NCT04723355|183371836|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
91739841|NCT04723355|183371836|OTHER||Cohen Kappa coefficient|0.69|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739842|NCT04723355|183371836|OTHER||Positive likelihood ratio|15.26|||||TWO_SIDED|95.0|7.51|30.99||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||30.99|7.51|
91739843|NCT04723355|183371836|OTHER||Negative likelihood ratio|0.23|||||TWO_SIDED|95.0|0.11|0.5||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.50|0.11|
91739844|NCT04723355|183371837|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.89|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.89|
91499486|NCT02663232|182868576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample type (paraffin-embedded blocks \[referral category\] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.505
91499487|NCT02663232|182868577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of method of fixation (buffered formalin \[referral category\] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.701
91531127|NCT00065468|182938752|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.0107|TWO_SIDED|95.0|0.62|0.94|||Log Rank|Stratified by prior nephrectomy and region||||0.94|0.62|0.0107
91531128|NCT00065468|182938753|SUPERIORITY_OR_OTHER|||||||0.1361|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1361
91739845|NCT04723355|183371837|OTHER||Sensitivity|0.58|||||TWO_SIDED|95.0|0.28|0.85||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.85|0.28|
91739846|NCT04723355|183371837|OTHER||Specificity|0.96|||||TWO_SIDED|95.0|0.92|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.92|
91739847|NCT04723355|183371837|OTHER||Positive predictive value|0.5|||||TWO_SIDED|95.0|0.23|0.77||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.77|0.23|
91739848|NCT04723355|183371837|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
91739849|NCT04723355|183371837|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739850|NCT04723355|183371837|OTHER||Positive likelihood ratio|13.92|||||TWO_SIDED|95.0|5.84|33.17||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||33.17|5.84|
91739851|NCT04723355|183371837|OTHER||Negative likelihood ratio|0.43|||||TWO_SIDED|95.0|0.22|0.85||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.85|0.22|
91739852|NCT04723355|183371838|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.95|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.95|
91739853|NCT04723355|183371838|OTHER||Sensitivity|0.75|||||TWO_SIDED|95.0|0.19|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.19|
91739854|NCT04723355|183371838|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.96|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.96|
91739855|NCT04723355|183371838|OTHER||Positive predictive value|0.6|||||TWO_SIDED|95.0|0.15|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.15|
91739856|NCT04723355|183371838|OTHER||Negative predictive value|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
91739857|NCT04723355|183371838|OTHER||Cohen Kappa coefficient|0.66|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739858|NCT04723355|183371838|OTHER||Positive likelihood ratio|65.63|||||TWO_SIDED|95.0|14.8|291.07||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||291.07|14.80|
91739859|NCT04723355|183371838|OTHER||Negative likelihood ratio|0.25|||||TWO_SIDED|95.0|0.05|1.38||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1.38|0.05|
91739860|NCT04723355|183371839|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.99|0.94|
91739861|NCT04723355|183371839|OTHER||Sensitivity|0.64|||||TWO_SIDED|95.0|0.31|0.89||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.89|0.31|
91739862|NCT04723355|183371839|OTHER||Specificity|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
91739863|NCT04723355|183371839|OTHER||Positive predictive value|1.0|||||TWO_SIDED|95.0|0.59|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.59|
91739864|NCT04723355|183371839|OTHER||Negative predictive value|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.94|
91739865|NCT04723355|183371839|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
91739866|NCT04723355|183371839|OTHER|||||||||||||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.|The positive likelihood ratio could not be calculated due to the value of zero in the denominator|||
91739867|NCT04723355|183371839|OTHER||Negative likelihood ratio|0.36|||||TWO_SIDED|95.0|0.17|0.79||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.79|0.17|
91739868|NCT04723355|183371841|OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-6.2|4.31||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||4.31|-6.20|
91739869|NCT04723355|183371841|OTHER||Lin´s concordance correlation coeficient|0.97|||||TWO_SIDED|95.0|0.96|0.98||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.98|0.96|
91739870|NCT04723355|183371842|OTHER||Mean Difference (Final Values)|-2.71|||||TWO_SIDED|95.0|-17.09|11.67||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||11.67|-17.09|
91739871|NCT04723355|183371842|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
91739872|NCT04723355|183371843|OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|95.0|-5.43|6.22||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||6.22|-5.43|
91499488|NCT02663232|182868578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Berslow thickness (≤1 mm \[referral category\] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.683
91739873|NCT04723355|183371843|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
91739874|NCT04723355|183371844|OTHER||Mean Difference (Final Values)|-6.37|||||TWO_SIDED|95.0|-1391.46|1378.72||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1378.72|-1391.46|
91739875|NCT04723355|183371844|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.94|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.94|
91531129|NCT00065468|182938753|SUPERIORITY_OR_OTHER|||||||0.1062|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1062
91739876|NCT04723355|183371845|OTHER||Mean Difference (Final Values)|11.04|||||TWO_SIDED|95.0|-2089.58|2111.65||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||2111.65|-2089.58|
91739877|NCT04723355|183371845|OTHER||Lin´s concordance correlation coeficient|0.92|||||TWO_SIDED|95.0|0.89|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.89|
91739878|NCT04723355|183371846|OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-5.45|5.2||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||5.20|-5.45|
91499489|NCT02663232|182868579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Ulceration (no \[referral category\] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.615
91499490|NCT02663232|182868580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.949|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of presence of regression (Without regression \[referral category\] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.949
91739879|NCT04723355|183371846|OTHER||Lin´s concordance correlation coeficient|0.93|||||TWO_SIDED|95.0|0.91|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.91|
91739880|NCT04723355|183371847|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-13.38|12.07||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||12.07|-13.38|
91739881|NCT04723355|183371847|OTHER||Lin´s concordance correlation coeficient|0.987|||||TWO_SIDED|95.0|0.98|0.99||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.99|0.98|
91739882|NCT04723355|183371848|OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.75|1.56||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1.56|-1.75|
91739883|NCT04723355|183371848|OTHER||Lin´s concordance correlation coeficient|0.9976|||||TWO_SIDED|95.0|0.997|0.998||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.998|0.997|
91739884|NCT04723355|183371849|SUPERIORITY||chi-squared test statistic|23.529|||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
91739885|NCT01127633|183371860|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.|Median Difference (Net)|-0.02||||0.974|TWO_SIDED|95.0|-1.14|1.11|||Mixed Models Analysis|||||1.11|-1.14|0.974
91739886|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.86|1.05|||ANOVA|||Anti-HPV 6||1.05|0.86|<0.001
91739887|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
91739888|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.85|1.04|||ANOVA|||Anti-HPV 16||1.04|0.85|<0.001
91739889|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07|||ANOVA|||Anti-HPV 18||1.07|0.84|<0.001
91739890|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANOVA|||Anti-HPV 31||1.06|0.84|<0.001
91739891|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||ANOVA|||Anti-HPV 33||1.00|0.81|<0.001
91739892|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.86|1.11|||ANOVA|||Anti-HPV 45||1.11|0.86|<0.001
91739893|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-HPV 52||1.06|0.85|<0.001
91739894|NCT01073293|183371875|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANOVA|||Anti-HPV 58||0.99|0.80|<0.001
91739895|NCT01073293|183371880|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.2|||<|0.001|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||1.4|-0.7|<0.001
91499491|NCT02663232|182868581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Vascular invasion (Without vascular invasion \[referral category\] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.374
91531130|NCT00065468|182938754|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||<0.0001
91531131|NCT00065468|182938754|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.0011
91531132|NCT00065468|182938756|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76|||Log Rank|Stratified by prior nephrectomy and region||||0.76|0.51|<0.0001
91531133|NCT00065468|182938756|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73||||0.002|TWO_SIDED|95.0|0.6|0.89|||Log Rank|Stratified by prior nephrectomy and region||||0.89|0.60|0.0020
91739896|NCT01073293|183371880|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||1.2|-1.1|<0.001
91739897|NCT01073293|183371881|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-PT||1.06|0.85|<0.001
91739898|NCT01073293|183371881|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.9|1.08|||ANOVA|||Anti-FHA||1.08|0.90|<0.001
91739899|NCT01073293|183371881|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.09|||ANOVA|||Anti-PRN||1.09|0.80|<0.001
91739900|NCT01073293|183371881|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.89||||0.005|TWO_SIDED|95.0|0.72|1.11|||ANOVA|||Anti-FIM 2/3||1.11|0.72|0.005
91739901|NCT01073293|183371882|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 1||0.8|-1.2|<0.001
91499492|NCT02730455|182868586|SUPERIORITY||Odds Ratio (OR)|0.64||||0.086|TWO_SIDED|95.0|0.38|1.07|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline National Institute of Health Stroke Scale (NIHSS) category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tissue plasminogen activator (tPA) use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, United States of America \[USA\]) as covariates and unstructured working correlation structure||1.07|0.38|0.086
91739902|NCT01073293|183371882|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 2||0.8|-1.2|<0.001
91739903|NCT01073293|183371882|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.8|||Miettinen and Nurminen|||Poliovirus type 3||0.8|-0.8|<0.001
91739904|NCT00512278|183371887|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated||||||0.718|||||||t-test, 2 sided|||||||0.718
91739905|NCT00512278|183371889|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.||||||0.718|TWO_SIDED|95.0||||Univariate and multivariable logistic regression were used for factors associated with an SVR.|t-test, 2 sided|||SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of \< 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.||||0.718
91739906|NCT00775268|183371892|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
91739907|NCT00775268|183371893|SUPERIORITY|||||||0.0313|||||||Wilcoxon matched-pairs signed rank test|||||||0.0313
91739908|NCT03723980|183371924|SUPERIORITY||Mean Difference (Net)|2.96||||0.329|TWO_SIDED|95.0||||"the calculated p value is for time interval of 4 hours~threshold for statistical significance= \<0.05"|ANOVA|For multiple comparisons between groups, post hoc (LSD) was applied||||||0.329
91739909|NCT03723980|183371924|SUPERIORITY||Mean Difference (Net)|-0.92||||0.764|TWO_SIDED|95.0||||"The calculated p value is for time interval of 12 hours~threshold for statistical significance= \<0.05"|ANOVA|||||||0.764
91739910|NCT03723980|183371924|SUPERIORITY||Mean Difference (Net)|-1.57||||0.605|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 2~threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
91739911|NCT03723980|183371924|SUPERIORITY||Mean Difference (Net)|-0.82||||0.786|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 3~threshold for statistical significance= \<0.05"|ANOVA|||||||0.786
91739912|NCT03723980|183371924|SUPERIORITY||Mean Difference (Net)|-0.72||||0.813|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 4~threshold for statistical significance= \<0.05"|ANOVA|||||||0.813
91739913|NCT03723980|183371926|OTHER||Mean Difference (Net)|2.97|STANDARD_ERROR_OF_MEAN|3.0||0.334|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.334
91739914|NCT03723980|183371926|OTHER||Mean Difference (Net)|2.33|STANDARD_ERROR_OF_MEAN|3.0||0.448|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.448
91739915|NCT03723980|183371926|OTHER||Mean Difference (Net)|5.88|STANDARD_ERROR_OF_MEAN|3.0||0.056|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.056
91499493|NCT02730455|182868586|SUPERIORITY||Odds Ratio (OR)|0.57||||0.031|TWO_SIDED|95.0|0.34|0.95|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||0.95|0.34|0.031
91499494|NCT02730455|182868587|SUPERIORITY||Odds Ratio (OR)|0.67||||0.222|TWO_SIDED|95.0|0.35|1.28|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.28|0.35|0.222
91739916|NCT03723980|183371926|OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.0||0.76|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.760
91739917|NCT03723980|183371926|OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|3.0||0.828|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.828
91739918|NCT03723980|183371926|OTHER||Mean Difference (Net)|11.8|STANDARD_ERROR_OF_MEAN|2.9||0|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.000
91739919|NCT03723980|183371926|OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|2.9||0.605|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
91499495|NCT02730455|182868587|SUPERIORITY||Odds Ratio (OR)|0.54||||0.073|TWO_SIDED|95.0|0.28|1.06|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.06|0.28|0.073
91739920|NCT03723980|183371926|OTHER||Mean Difference (Net)|5.23|STANDARD_ERROR_OF_MEAN|2.9||0.8|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.80
91739921|NCT03723980|183371926|OTHER||Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.574
91739922|NCT03723980|183371926|OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|2.9||0.796|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.796
91739923|NCT03723980|183371927|OTHER||Mean Difference (Net)|-0.6||||0.412|TWO_SIDED|||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.412
91739924|NCT03723980|183371927|OTHER||Mean Difference (Net)|2.8||||0.94|TWO_SIDED|||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.94
91739925|NCT03723980|183371927|OTHER||Mean Difference (Net)|5.5||||0.035|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 2~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.035
91739926|NCT03723980|183371927|OTHER||Mean Difference (Net)|4.4||||0.023|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 3~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.023
91739927|NCT03723980|183371927|OTHER||Median Difference (Net)|4.3||||0.02|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 4.~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.020
91739928|NCT03723980|183371928|OTHER|||||||0.15||||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.15
91739929|NCT03723980|183371928|OTHER|||||||0.36||||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.36
91739930|NCT03723980|183371928|OTHER|||||||0.13||||||"The p-value calculated is for pain score difference at day 2~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.13
91739931|NCT03723980|183371928|OTHER|||||||0.55||||||"The p-value calculated is for pain score difference at day 3~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.55
91499496|NCT02730455|182868588|SUPERIORITY||Odds Ratio (OR)|0.56||||0.085|TWO_SIDED|95.0|0.29|1.08|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.08|0.29|0.085
91499497|NCT02730455|182868588|SUPERIORITY||Odds Ratio (OR)|0.54||||0.067|TWO_SIDED|95.0|0.28|1.04|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.04|0.28|0.067
91531134|NCT04496167|182938759|OTHER||Least Square Mean Treatment Difference|1.386||||0.659|TWO_SIDED|95.0|-4.804|7.577||Considered significant if p-value is less than 0.05.|MMRM||"The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.~Treatment difference: EN3835 - Placebo"|Mixed Model Repeated Measures (MMRM) was performed to estimate the change from Baseline treatment effect of the adapted ASES composite score in the affected shoulder comparing EN3835 to placebo treatment.||7.577|-4.804|0.659
91531135|NCT00598481|182938791|SUPERIORITY|||||||0.005|||||||One-sided Poisson-regression|||||||0.005
91499498|NCT02730455|182868589|SUPERIORITY||Adjusted Mean Difference|-7.7||||0.106|TWO_SIDED|95.0|-16.97|1.64|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.64|-16.97|0.106
91499499|NCT02730455|182868589|SUPERIORITY||Adjusted Mean Difference|-6.1||||0.202|TWO_SIDED|95.0|-15.43|3.27|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.27|-15.43|0.202
91499500|NCT02730455|182868590|SUPERIORITY||Adjusted Mean Difference|-0.3||||0.78|TWO_SIDED|95.0|-2.64|1.99|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.99|-2.64|0.780
91499501|NCT02730455|182868590|SUPERIORITY||Adjusted Mean Difference|-0.6||||0.622|TWO_SIDED|95.0|-2.89|1.73|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.73|-2.89|0.622
91499502|NCT02730455|182868591|SUPERIORITY||Adjusted Mean Difference|1.2||||0.315|TWO_SIDED|95.0|-1.1|3.4|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.40|-1.10|0.315
91499503|NCT02730455|182868591|SUPERIORITY||Adjusted Mean Difference|-0.7||||0.542|TWO_SIDED|95.0|-2.96|1.56|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.56|-2.96|0.542
91499504|NCT02730455|182868594|SUPERIORITY|||||||0.028|||||||Cochran-Armitage trend test|||"mRS: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome.~Dose levels are log transformed."||||0.028
91739932|NCT03723980|183371928|OTHER|||||||0.17||||||"The p-value calculated is for pain score difference at day 4~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.17
91531136|NCT00598481|182938792|SUPERIORITY||Geometric mean ratio|3.0||||0.003|TWO_SIDED|95.0|1.45|6.19||P value related to geometric mean ratio at 1 year post gene therapy compared to baseline|Mixed Model Repeated Measures|||||6.19|1.45|0.003
91739933|NCT04263766|183371932|EQUIVALENCE|We tested whether TMS delivered to DLPFC had a difference effect on confidence compared to delivered to Vertex.|||||<|0.001|||||||t-test, 2 sided|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in confidence across all 4 delay conditions compared to TMS to the vertex.||||<.001
91499505|NCT02730455|182868594|SUPERIORITY|||||||0.049|||||||Cochran-Armitage trend test|||BI: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome. Dose levels are log transformed.||||0.049
91739934|NCT04263766|183371932|EQUIVALENCE|We tested whether TMS to DLPFC leads to equivalent increase in confidence for four delay conditions.||||||0.99|||||||ANOVA|||||||0.99
91739935|NCT04263766|183371932|EQUIVALENCE|We tested whether TMS delivered to Vertex leads to a same effect on confidence regardless of the delay conditions.||||||0.83|||||||ANOVA|||||||0.83
91739936|NCT04263766|183371933|EQUIVALENCE|We used a two-way ANOVA to test whether TMS affected Mratio differently for DLPFC and Vertex and across different delay conditions.|||||>|0.19|||||||ANOVA|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in Mratio across all 4 delay conditions compared to TMS to the vertex.||||>0.19
91739937|NCT04232943|183371939|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.56|2.464|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 1||2.464|0.560|
91739938|NCT04232943|183371939|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.606|1.51|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 3||1.510|0.606|
91739939|NCT01891396|183371959|SUPERIORITY|||||||0.0099|||||||ANOVA|||||||0.0099
91739940|NCT01891396|183371960|SUPERIORITY|||||||0.0367|||||||ANOVA|||||||0.0367
91739941|NCT01891396|183371961|SUPERIORITY|||||||0.0289|||||||ANOVA|||||||0.0289
91739942|NCT01891396|183371962|SUPERIORITY|||||||0.0141|||||||ANOVA|||||||0.0141
91499506|NCT00001723|182868649|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||||||0.007
91499507|NCT01324999|182868669|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing baseline to week 24.||||0.68
91499508|NCT01324999|182868670|OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
91499509|NCT01324999|182868671|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
91499510|NCT01324999|182868672|OTHER|||||||0.19|||||||t-test, 2 sided|||comparing baseline to week 24||||0.19
91499511|NCT01324999|182868673|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing Baseline to week 24.||||0.68
91499512|NCT01324999|182868674|OTHER|||||||0.92|||||||t-test, 2 sided|||comparing baseline to week 24||||0.92
91499513|NCT01324999|182868675|OTHER|||||||0.44|||||||t-test, 2 sided|||comparison of baseline to week 24||||0.44
91499514|NCT01712490|182868677|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.035|TWO_SIDED|95.0|0.603|0.983|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (\<) 1 favors A+AVD arm.||0.983|0.603|0.035
91531137|NCT00598481|182938792|SUPERIORITY||Geometric mean ratio|5.4|||<|0.001|TWO_SIDED|95.0|2.63|11.25||P value related to geometric mean ratio at 2 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||11.25|2.63|<0.001
91739943|NCT01891396|183371963|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
91739944|NCT01891396|183371964|SUPERIORITY|||||||0.0533|||||||ANOVA|||||||0.0533
91739945|NCT01891396|183371965|SUPERIORITY|||||||0.0323|||||||ANOVA|||||||0.0323
91739946|NCT01891396|183371966|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
91739947|NCT01891396|183371967|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.0030
91739948|NCT01891396|183371968|SUPERIORITY|||||||0.044|||||||ANOVA|||||||0.0440
91739949|NCT01891396|183371969|SUPERIORITY|||||||0.0579|||||||ANOVA|||||||0.0579
91739950|NCT01891396|183371970|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
91739951|NCT01891396|183371971|SUPERIORITY|||||||0.0046|||||||ANOVA|||||||0.0046
91739952|NCT01891396|183371972|SUPERIORITY|||||||0.0029|||||||ANOVA|||||||0.0029
91739953|NCT01891396|183371973|SUPERIORITY|||||||0.0087|||||||ANOVA|||||||0.0087
91499515|NCT01712490|182868678|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.199|TWO_SIDED|95.0|0.448|1.184|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio \<1 favors A+AVD arm.||1.184|0.448|0.199
91739954|NCT01891396|183371974|SUPERIORITY|||||||0.0154|||||||ANOVA|||||||0.0154
91739955|NCT01891396|183371975|SUPERIORITY|||||||0.0227|||||||ANOVA|||||||0.0227
91739956|NCT01891396|183371976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
91739957|NCT01891396|183371977|SUPERIORITY|||||||0.0148|||||||ANOVA|||||||0.0148
91499516|NCT00060008|182868711|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91499517|NCT00560859|182868719|SUPERIORITY_OR_OTHER||difference of change from baseline|2.0||||0.16|||||||ANCOVA|||||||0.16
91499518|NCT03653637|182868771|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.263|TWO_SIDED|95.0|0.43|1.3|||Regression, Cox|This model adjusted for site and lifetime suicide attempt history.|The HR represents the PLF+TAU group compared to TAU.|||1.30|0.43|0.263
91739958|NCT01891396|183371978|SUPERIORITY|||||||0.0113|||||||ANOVA|||||||0.0113
91739959|NCT01891396|183371979|SUPERIORITY|||||||0.0016|||||||ANOVA|||||||0.0016
91739960|NCT01891396|183371980|SUPERIORITY|||||||0.0056|||||||ANOVA|||||||0.0056
91739961|NCT01891396|183371981|SUPERIORITY|||||||0.0095|||||||ANOVA|||||||0.0095
91739962|NCT01891396|183371982|SUPERIORITY|||||||0.0136|||||||ANOVA|||||||0.0136
91739963|NCT01891396|183371983|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
91739964|NCT01891396|183371984|SUPERIORITY|||||||0.0059|||||||ANOVA|||||||0.0059
91739965|NCT01194245|183371999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.|LS Means Difference|0.05||||0.2878|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.15|-0.05|0.2878
91739966|NCT01824290|183372040|SUPERIORITY||Mean Difference (Final Values)|23.88|STANDARD_ERROR_OF_MEAN|29.114|||TWO_SIDED|80.0|-14.25|62.0||||||||62.00|-14.25|
91739967|NCT01490918|183372046|SUPERIORITY|||||||0.0036||||||The threshold for statistical significance was p=0.05|ANCOVA|Baselin HbA1c as covariate||primary outcome efficacy will be evaluated between group 1(placebo + metfromin + sitagliptin) and 2 (sitagliptine + metformin + acarbose)||||0.0036
91739968|NCT01490918|183372047|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.05|ANCOVA|Baseline HbA1c as covariate||||||<0.0001
91739969|NCT01490918|183372048|SUPERIORITY|||||||0.0185||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline PPG2hr as covariate||||||0.0185
91739970|NCT01490918|183372049|SUPERIORITY|||||||0.0356||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.0356
91739971|NCT01490918|183372050|SUPERIORITY|||||||0.8258||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.8258
91739972|NCT01490918|183372051|SUPERIORITY|||||||0.9217||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.9217
91739973|NCT01490918|183372052|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.16
91739974|NCT01490918|183372053|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.004
91739975|NCT01490918|183372054|SUPERIORITY|||||||0.292||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.292
91739976|NCT01490918|183372055|SUPERIORITY|||||||0.314||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.314
91739977|NCT01490918|183372056|SUPERIORITY|||||||0.7563||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.7563
91739978|NCT02099084|183372057|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.74
91739979|NCT02099084|183372058|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 2-hours. Level of significance = .05||||0.20
91739980|NCT02099084|183372058|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 8-hours. Level of significance = .05||||0.17
91739981|NCT02099084|183372059|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.075
91739982|NCT02099084|183372062|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.42
91739983|NCT02099084|183372063|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.34
91739984|NCT02706925|183372072|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2951|STANDARD_DEVIATION|0.0352|||TWO_SIDED|95.0|1.2242|1.366|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.3660|1.2242|
91499519|NCT03653637|182868774|SUPERIORITY||Slope|-0.07||||0.72|TWO_SIDED|95.0|-0.43|0.3||p-value is for the treatment-by-time interaction|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|||PLF is coded as 1 and TAU is coded as 0.|.30|-.43|.72
91499520|NCT03653637|182868775|SUPERIORITY||Slope|-0.1||||0.23|TWO_SIDED|95.0|-0.43|0.3||The p-value is for the treatment-by-time interaction|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|||PLF is coded as 1 and TAU is coded as 0.|.30|-.43|.23
91499521|NCT03653637|182868776|SUPERIORITY||Slope|0.27||||0.09|TWO_SIDED|96.0|-0.04|0.58||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|||PLF is coded as 1 and TAU is coded as 0.|.58|-.04|.09
91499522|NCT03653637|182868777|SUPERIORITY||Slope|1.17||||0.15|TWO_SIDED|95.0|-0.42|2.76||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site.|PLF is coded as 1 and TAU is coded as 0.|||2.76|-.42|.15
91499523|NCT03653637|182868778|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.52|TWO_SIDED|95.0|-1.78|0.91|||t-test, 2 sided|||||.91|-1.78|.52
91739985|NCT02706925|183372072|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.088|STANDARD_DEVIATION|0.0843|||TWO_SIDED|95.0|0.9128|1.2633|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2633|0.9128|
91739986|NCT02706925|183372072|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1846|STANDARD_DEVIATION|0.3328|||TWO_SIDED|95.0|0.4791|1.89|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.8900|0.4791|
91739987|NCT02706925|183372073|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2114|STANDARD_DEVIATION|0.035|||TWO_SIDED|95.0|1.1409|1.2818|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2818|1.1409|
91499524|NCT03653637|182868779|SUPERIORITY||Median Difference (Final Values)|188.5||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The estimation parameter statistic provided is the U value from the Mann-Whitney U test.|||||.83
91531138|NCT00598481|182938792|SUPERIORITY||Geometric mean ratio|6.5|||<|0.001|TWO_SIDED|95.0|3.08|13.64||P value related to geometric mean ratio at 3 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||13.64|3.08|<0.001
91531139|NCT01232556|182938884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083||||0.708|TWO_SIDED|95.0|0.82|1.44||A one sided 0.025 level testing plan was specified with two interim analyses and final testing level at one-sided 0.023.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline Secondary International Prognostic Index (sIPI), and best response to most recent chemo therapy.|Primary null hypothesis: Equality of survival distributions. Sample size sufficient to have power 0.96 for an experimental/control hazard ratio of 0.6.||1.44|0.82|0.708
91739988|NCT02706925|183372073|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0771|STANDARD_DEVIATION|0.0524|||TWO_SIDED|95.0|0.9696|1.1845|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.1845|0.9696|
91739989|NCT02706925|183372073|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3969|STANDARD_DEVIATION|0.3965|||TWO_SIDED|95.0|0.5563|2.2375|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||2.2375|0.5563|
91499525|NCT03653637|182868781|SUPERIORITY||Slope|-0.22||||0.24|TWO_SIDED|95.0|-0.58|0.15||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|||PLF is coded as 1 and TAU is coded as 0.|.15|-.58|.24
91499526|NCT03653637|182868782|SUPERIORITY||Slope|0.07||||0.28|TWO_SIDED|95.0|-0.06|0.19||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.||"This analysis concerns the verbal aggression subscale."|PLF is coded as 1 and TAU is coded as 0.|.19|-.06|.28
91499527|NCT03653637|182868782|SUPERIORITY||Slope|-0.07||||0.48|TWO_SIDED|95.0|-0.25|0.12||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|PLF is coded as 1 and TAU is coded as 0.|"This analysis concerns the physical aggression subscale."||.12|-.25|.48
91499528|NCT03653637|182868782|SUPERIORITY||Slope|-0.08||||0.3|TWO_SIDED|95.0|-0.24|0.07||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|PLF is coded as 1 and TAU is coded as 0.|"This analysis concerns the anger subscale."||.07|-.24|.30
91739990|NCT00806260|183372086|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.07|||ONE_SIDED|90.0|0.21||||ANCOVA|||at alcohol level 0.10%|||0.21|
91739991|NCT00806260|183372086|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.05|||ONE_SIDED|90.0|0.12||||ANCOVA|||at alcohol level 0.07%|||0.12|
91499529|NCT03653637|182868782|SUPERIORITY||Slope|0.02||||0.82|TWO_SIDED|95.0|-0.17|0.22||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.||"This analysis concerns the hostility subscale."|PLF is coded as 1 and TAU is coded as 0.|.22|-.17|.82
91739992|NCT00806260|183372086|NON_INFERIORITY_OR_EQUIVALENCE|step-down test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|90.0|-0.03||||ANCOVA|||at alcohol level 0.04%|||-0.03|
91739993|NCT00806260|183372087|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.17|0.07|||ANCOVA|||at 2 hr timepoint||0.07|-0.17|
91739994|NCT00806260|183372087|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority test|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.18|0.04|||ANCOVA|||at 6 hr timepoint||0.04|-0.18|
91499530|NCT03653637|182868783|SUPERIORITY||Slope|-0.08||||0.41|TWO_SIDED|95.0|-0.27|0.11||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|PLF is coded as 1 and TAU is coded as 0.|||.11|-.27|.41
91499531|NCT03653637|182868784|SUPERIORITY||Slope|-0.13||||0.67|TWO_SIDED|95.0|-0.68|0.48||The p-value is for the treatment-by-time interaction.|Mixed Models Analysis|The mixed model has a random intercept for participant and is adjusted for site. Time is a linear effect.|PLF is coded as 1 and TAU is coded as 0.|||.48|-.68|.67
91739995|NCT00806260|183372087|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||at 2 hr timepoint||0.06|-0.08|
91739996|NCT00806260|183372087|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.13|0.05|||ANCOVA|||at 6 hr timepoint||0.05|-0.13|
91499532|NCT01346839|182868789|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Cox|||||||<0.05
91739997|NCT03682965|183372099|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91739998|NCT03682965|183372100|SUPERIORITY||||||<|0.05||||||The Holm-Bonferroni correction for multiple tests was used because the two outcomes are based on correlated data.|Clopper-Pearson binomial exact test|||The secondary efficacy endpoint was the percentage of days during peak pollen season for which the average total combined score was lower in the immunotherapy group than in the placebo group.||||<0.05
91739999|NCT03682965|183372102|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
91740000|NCT00953706|183372107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1509|TWO_SIDED|95.0|-0.6|4.1|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.||4.1|-0.6|0.1509
91740001|NCT00953706|183372108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.1||0.5408|TWO_SIDED|95.0|-2.9|5.6|||Mixed Models Analysis|||Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with the dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for for age and baseline value for CFQ-R score, using unstructured covariance matrix||5.6|-2.9|0.5408
91740002|NCT00953706|183372109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.4||0.0384|TWO_SIDED|95.0|-5.6|-0.2|||Mixed Models Analysis|||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous age and baseline value for age, sweat chloride, using unstructured covariance matrix.||-0.2|-5.6|0.0384
91740003|NCT00953706|183372110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.7265|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|||The analysis used the linear mixed model with treatment as fixed effects, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group (\< 18 years and ≥ 18 years) and percent predicted forced expiratory volume (FEV1) severity (\< 70%, ≥ 70% to ≤ 90%, \> 90%) at screening, with random intercept and random slope. Rate of change in the study period is the slope of weight versus time (days) multiplied by the number of days in the study period (112 days).||0.7|-1.1|0.7265
91499533|NCT02068443|182868794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.821|-0.48|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin alone (Metformin QD - Alogliptin alone).|||-0.480|-0.821|
91740004|NCT01214837|183372145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-7.0|||||TWO_SIDED|95.0|-14.0|-1.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.||-1|-14|
91740005|NCT01214837|183372145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-8.0|0.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.||0|-8|
91740006|NCT01214837|183372145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.||3|-3|
91499534|NCT02068443|182868794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of Alogliptin + Metformin Hydrochloride QD to Alogliptin + Metformin Hydrochloride BID.|LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|95.0|-0.026|0.247|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin + Metformin Hydrochloride BID (Metformin QD - Metformin BID).|||0.247|-0.026|
91499535|NCT02723084|182868805|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of -10%, then arm A was considered non-inferior to arm B.|Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-3.5|12.1|||||95% CI was calculated using the normal approximation to the binomial distribution.|Difference in SVR12 rates (Arm A - Arm B)||12.1|-3.5|
91531140|NCT01232556|182938885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.924||||0.271|TWO_SIDED|95.0|0.72|1.19||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|Second comparison in hierarchical testing strategy was used for power calculation.||1.19|0.72|0.271
91740007|NCT01214837|183372145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.||4|-2|
91740008|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.5|||||TWO_SIDED|95.0|-6.1|5.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||5|-6.1|
91499536|NCT00225251|182868855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.05|||||||t-test, 2 sided|||||||<.05
91499537|NCT01702454|182868860|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|8.97|||||TWO_SIDED|95.0|6.21|12.96|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||12.96|6.21|
91531141|NCT01232556|182938886|SUPERIORITY_OR_OTHER|||||||0.843||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.843
91531142|NCT01232556|182938887|SUPERIORITY_OR_OTHER|||||||0.714||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.714
91740009|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.8|||||TWO_SIDED|95.0|3.0|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||10.5|3|
91499538|NCT01702454|182868860|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|2.7|||||TWO_SIDED|95.0|1.81|4.02|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval|The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||4.02|1.81|
91740010|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-11.9|6.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||6|-11.9|
91760099|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02|||||TWO_SIDED|95.0|-1.48|-0.57||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.57|-1.48|
91499539|NCT01702454|182868860|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|3.94|||||TWO_SIDED|95.0|2.89|5.37|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||5.37|2.89|
91740011|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.3|||||TWO_SIDED|95.0|-3.3|13.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||13.7|-3.3|
91740012|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.4|||||TWO_SIDED|95.0|-7.5|2.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||2.3|-7.5|
91740013|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.3|||||TWO_SIDED|95.0|-4.4|4.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||4.7|-4.4|
91740014|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||3.4|-12.1|
91740015|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.9|||||TWO_SIDED|95.0|-1.9|11.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||11.8|-1.9|
91740016|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.04|||||TWO_SIDED|95.0|-3.7|3.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||3.8|-3.7|
91740017|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.2|||||TWO_SIDED|95.0|-2.2|4.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||4.8|-2.2|
91740018|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.3|||||TWO_SIDED|95.0|-8.4|7.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||7.7|-8.4|
91760100|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.89|0.11||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.11|-0.89|
91531143|NCT01232556|182938888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.142|TWO_SIDED|95.0|0.47|1.25|||Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|DOR was not part of the formal hypothesis testing strategy.||1.25|0.47|0.142
91531144|NCT01232556|182938889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2892|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||0.06|-0.02|0.2892
91531145|NCT01232556|182938890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.11||||0.1879|TWO_SIDED|95.0|-1.52|7.74|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||7.74|-1.52|0.1879
91499540|NCT01702454|182868860|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|6.71|||||TWO_SIDED|95.0|5.21|8.63|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||8.63|5.21|
91499541|NCT01702454|182868862|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|44.74|||||TWO_SIDED|95.0|35.87|52.84||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||52.84|35.87|
91499542|NCT01702454|182868862|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|45.31|||||TWO_SIDED|95.0|36.58|53.3||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||53.3|36.58|
91499543|NCT01702454|182868862|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|37.86||||||95.0|28.83|46.26||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||46.26|28.83|
91499544|NCT01702454|182868862|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in percentages|56.0||||||95.0|48.32|63.04||||||"To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.04|48.32|
91705203|NCT05153148|183304907|SUPERIORITY||Treatment Difference|-6.43|||=|0.018|TWO_SIDED|95.0|-11.73|-1.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.13|-11.73|=0.018
91705204|NCT05153148|183304907|SUPERIORITY||Treatment Difference|-5.23|||=|0.056|TWO_SIDED|95.0|-10.59|0.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.13|-10.59|=0.056
91705205|NCT05153148|183304908|SUPERIORITY||Risk Difference (RD)|11.9|||=|0.186|TWO_SIDED|95.0|-5.7|29.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.4|-5.7|=0.186
91705206|NCT05153148|183304908|SUPERIORITY||Risk Difference (RD)|14.6|||=|0.101|TWO_SIDED|95.0|-2.8|32.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|32.1|-2.8|=0.101
91705207|NCT05153148|183304908|SUPERIORITY||Risk Difference (RD)|29.0|||=|0.002|TWO_SIDED|95.0|10.5|47.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|47.6|10.5|=0.002
91705208|NCT05153148|183304909|SUPERIORITY||Risk Difference (RD)|4.5|||=|0.54|TWO_SIDED|95.0|-10.0|19.0|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.0|-10.0|=0.540
91705209|NCT05153148|183304909|SUPERIORITY||Risk Difference (RD)|5.2|||=|0.466|TWO_SIDED|95.0|-8.8|19.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.3|-8.8|=0.466
91705210|NCT05153148|183304909|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.034|TWO_SIDED|95.0|1.2|31.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|31.3|1.2|=0.034
91705211|NCT00474786|183304916|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1933|TWO_SIDED|95.0|0.71|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.71|0.1933
91499545|NCT01702454|182868864|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|62.43|||||TWO_SIDED|95.0|55.27|68.89||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains||68.89|55.27|
91499546|NCT01702454|182868864|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|47.4|||||TWO_SIDED|95.0|39.08|55.06||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||55.06|39.08|
91740019|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|10.2|||||TWO_SIDED|95.0|3.4|17.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||17.2|3.4|
91740020|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-1.7|
91740021|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-2.1|
91740022|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.1|||||TWO_SIDED|95.0|-9.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||3.4|-9.7|
91740023|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.5|9.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||9.7|-1.5|
91740024|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|vaccine group difference|1.9|||||TWO_SIDED|95.0|-1.2|5.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||5.7|-1.2|
91740025|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|2.5|||||TWO_SIDED|95.0|-0.2|6.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||6.3|-0.2|
91740026|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-6.3|-0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||-0.2|-6.3|
91740027|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.2|||||TWO_SIDED|95.0|-6.2|0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||0.2|-6.2|
91499547|NCT01702454|182868864|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in SPR|56.68|||||TWO_SIDED|95.0|49.44|63.43||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||63.43|49.44|
91740028|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-7.1|1.6|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||1.6|-7.1|
91740029|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-5.5|||||TWO_SIDED|95.0|-11.3|-0.9|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||-0.9|-11.3|
91740030|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-1.7|
91740031|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-2.1|
91740032|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.9|||||TWO_SIDED|95.0|-4.2|8.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||8.2|-4.2|
91740033|NCT01214837|183372152|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.5|||||TWO_SIDED|95.0|-1.4|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||10.5|-1.4|
91740034|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.13|0.77|
91740035|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.25|0.83|
91499548|NCT01702454|182868864|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|56.72|||||TWO_SIDED|95.0|49.41|63.49||||||"To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.49|49.41|
91499549|NCT01067456|182868897|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.57||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
91499550|NCT00227903|182868908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power||||0.88
91499551|NCT00227903|182868909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||Fisher Exact|||||||0.08
91499552|NCT00227903|182868910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison.|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power.||||0.88
91499553|NCT00227903|182868911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Fisher Exact|||||||0.41
91499554|NCT00227903|182868912|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.79|TWO_SIDED|95.0|0.36|1.67|||Regression, Logistic|||||1.67|0.36|0.79
91499555|NCT00227903|182868913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.42|2.62|||Regression, Logistic|||||2.62|0.42|0.79
91499556|NCT00227903|182868914|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.88|TWO_SIDED|95.0|0.34|2.72|||Regression, Logistic|||||2.72|0.34|0.88
91499557|NCT00227903|182868915|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.88|TWO_SIDED|95.0|0.57|2.57|||Regression, Logistic|||||2.57|0.57|0.88
91499558|NCT00227903|182868916|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.5|TWO_SIDED|95.0|0.32|1.84|||Regression, Logistic|||||1.84|0.32|0.50
91499559|NCT00227903|182868917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
91499560|NCT00227903|182868918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
91499561|NCT00227903|182868919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
91499562|NCT00227903|182868920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
91499563|NCT00227903|182868921|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.5|TWO_SIDED|95.0|0.27|2.11|||Regression, Logistic|||||2.11|0.27|0.50
91499564|NCT00227903|182868922|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.07|TWO_SIDED|95.0|0.44|3.14|||Regression, Logistic|||||3.14|0.44|0.07
91499565|NCT00227903|182868923|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.07|TWO_SIDED|95.0|0.47|4.52|||Regression, Logistic|||||4.52|0.47|0.07
91499566|NCT00227903|182868924|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.07|TWO_SIDED|95.0|0.08|1.02|||Regression, Logistic|||||1.02|0.08|0.07
91499567|NCT00227903|182868925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.1|3.9|||Regression, Logistic|||||3.90|0.10|0.07
91499568|NCT00227903|182868926|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.91|TWO_SIDED|95.0|0.32|4.2|||Regression, Logistic|||||4.20|0.32|0.91
91499569|NCT00227903|182868927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.91|TWO_SIDED|95.0|0.35|5.07|||Regression, Logistic|||||5.07|0.35|0.91
91499570|NCT00227903|182868928|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.91|TWO_SIDED|95.0|0.14|5.23|||Regression, Logistic|||||5.23|0.14|0.91
91499571|NCT00227903|182868929|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.91|TWO_SIDED|95.0|0.21|7.12|||Regression, Logistic|||||7.12|0.21|0.91
91499572|NCT00227903|182868930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.04|TWO_SIDED|95.0|0.46|3.55|||Regression, Logistic|||||3.55|0.46|.04
91499573|NCT00227903|182868931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.04|TWO_SIDED|95.0|0.35|4.17|||Regression, Logistic|||||4.17|0.35|0.04
91499574|NCT00227903|182868932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.25||||0.04|TWO_SIDED|95.0|0.04|1.63|||Regression, Logistic|||||1.63|0.04|0.04
91499575|NCT00227903|182868933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.04|TWO_SIDED|95.0|0.04|3.74|||Regression, Logistic|||||3.74|0.04|0.04
91535606|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.8||0.6947|TWO_SIDED|95.0|-2.85|4.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.27|-2.85|0.6947
91499576|NCT00227903|182868934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.01
91499577|NCT00227903|182868935|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
91499578|NCT04309656|182868954|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|85.85||||0.0001|TWO_SIDED|90.0|81.21|90.75|||ANOVA|||||90.75|81.21|0.0001
91499579|NCT04309656|182868954|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|92.99||||0.3001|TWO_SIDED|90.0|82.65|104.62|||ANOVA|||||104.62|82.65|0.3001
91499580|NCT04309656|182868955|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|100.6||||0.6686|TWO_SIDED|90.0|98.23|103.03|||ANOVA|||||103.03|98.23|0.6686
91499581|NCT04309656|182868955|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.7||||0.0745|TWO_SIDED|90.0|81.2|99.1|||ANOVA|||||99.10|81.20|0.0745
91499582|NCT04309656|182868956|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|101.03||||0.4683|TWO_SIDED|90.0|98.65|103.47|||ANOVA|||||103.47|98.65|0.4683
91499583|NCT04309656|182868956|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.63||||0.0734|TWO_SIDED|90.0|81.1|99.05|||ANOVA|||||99.05|81.10|0.0734
91740036|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.14|||||TWO_SIDED|95.0|0.93|1.4|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.4|0.93|
91499584|NCT03720470|182868961|SUPERIORITY||Difference in percentage|23.1|||<|0.0001|TWO_SIDED|95.0|14.7|31.4|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||31.4|14.7|<0.0001
91740037|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.25|||||TWO_SIDED|95.0|1.01|1.55|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.55|1.01|
91740038|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||0.96|0.62|
91740039|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||1.18|0.75|
91740040|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.21|0.86|
91740041|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5|GMC ratio|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.29|0.89|
91740042|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.04|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.04|0.69|
91740043|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.88|1.37|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.37|0.88|
91499585|NCT03720470|182868961|SUPERIORITY||Difference in Percentage|34.8|||<|0.0001|TWO_SIDED|95.0|26.1|43.5|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.5|26.1|<0.0001
91499586|NCT03720470|182868962|SUPERIORITY||Difference in percentage|31.9|||<|0.0001|TWO_SIDED|95.0|22.2|41.6|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||41.6|22.2|<0.0001
91499587|NCT03720470|182868962|SUPERIORITY||Difference in Percentage|43.2|||<|0.0001|TWO_SIDED|95.0|33.7|52.7|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||52.7|33.7|<0.0001
91499588|NCT03720470|182868963|SUPERIORITY||Difference in percentage|17.9||||0.0002|TWO_SIDED|95.0|9.5|26.3|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||26.3|9.5|0.0002
91499589|NCT03720470|182868963|SUPERIORITY||Difference in Percentage|34.9|||<|0.0001|TWO_SIDED|95.0|26.0|43.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.0|<.0001
91740044|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.05|0.69|
91499590|NCT03720470|182868963|SUPERIORITY||Difference in Percentage|5.2||||0.2084|TWO_SIDED|95.0|-2.9|13.4|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||13.4|-2.9|0.2084
91499591|NCT03720470|182868963|SUPERIORITY||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.5|30.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.7|13.5|<0.0001
91705212|NCT00474786|183304917|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1888|TWO_SIDED|95.0|0.7|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.70|0.1888
91705213|NCT00474786|183304919|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.31||||0.0144|TWO_SIDED|95.0|1.05|1.63||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.|Log Rank||Hazard ratio \<1 means temsirolimus (TEMSR) is at lower risk.|||1.63|1.05|0.0144
91705214|NCT02892513|183304923|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91740045|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.3|0.83|
91760101|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-1.44|-0.45||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.45|-1.44|
91760102|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.71|-0.71||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.71|-1.71|
91760103|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-1.59|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.59|
91760104|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-0.95|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.95|
91760105|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.65|-0.66||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.66|-1.65|
91760106|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.96|0.08||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.96|
91760107|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.48|-0.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.48|
91499592|NCT03720470|182868964|OTHER||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.7|30.5|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.5|13.7|<0.0001
91499593|NCT03720470|182868964|OTHER||Difference in Percentage|35.0|||<|0.0001|TWO_SIDED|95.0|26.3|43.7|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.3|<0.0001
91499594|NCT03720470|182868964|OTHER||Difference in Percentage|-3.5|||||TWO_SIDED|95.0|-12.2|5.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||5.2|-12.2|
91499595|NCT03720470|182868964|OTHER||Difference in Percentage|9.4|||||TWO_SIDED|95.0|0.4|18.5||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||18.5|0.4|
91740046|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||0.95|0.67|
91740047|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||1.25|0.87|
91740048|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.66|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||0.96|0.66|
91740049|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||1.31|0.87|
91740050|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.27|0.84|
91740051|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.3|0.83|
91740052|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||0.87|0.59|
91740053|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.89|1.36|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||1.36|0.89|
91740054|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.27|0.83|
91740055|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.77|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.21|0.77|
91740056|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.22|0.82|
91499596|NCT03720470|182868965|OTHER||Difference in percentage|24.1|||<|0.0001|TWO_SIDED|95.0|14.0|34.1|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||34.1|14.0|<0.0001
91499597|NCT03720470|182868965|OTHER||Difference in Percentage|30.1|||<|0.0001|TWO_SIDED|95.0|20.3|39.8|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||39.8|20.3|<0.0001
91531146|NCT03785340|182938897|SUPERIORITY|"The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found:~1. Change from baseline to 4 weeks (Day 28) in SANDE score~2. Change from baseline to 4 weeks (Day 28) in Lissamine Green conjunctival staining scores~3. Change from baseline to 2 weeks (Day 14) in SANDE score~4. Change from baseline to 2 weeks (Day 14) in Lissamine Green conjunctival staining scores"|Least squares mean difference|-0.844||||0.739|TWO_SIDED|95.0|-5.823|4.134|||Mixed Model Repeated Measures Analysis||Change from baseline to 4 weeks (Day 28) in SANDE score; OCU-310 vs. Placebo|Four endpoints (two primary and two secondary) were to be tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found. The analysis of the four outcomes employed a repeated measures mixed model with mean change from baseline score at the stated time point as the response with baseline score as a covariate and treatment, visit, and their interaction as fixed effects. The least squares mean difference (OCU 310 - placebo) at the stated time point was tested.||4.134|-5.823|0.739
91740057|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.86|1.32|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.32|0.86|
91740058|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.97|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||0.97|0.62|
91531147|NCT02584855|182938914|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.||||<0.001
91740059|NCT01214837|183372153|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||1.13|0.7|
91740060|NCT00834197|183372163|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.59||||||90.0|95.76|105.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.65|95.76|
91740061|NCT00834197|183372164|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.17||||||90.0|94.82|101.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.65|94.82|
91740062|NCT00834197|183372165|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.25||||||90.0|95.22|101.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.39|95.22|
91740063|NCT04050384|183372177|OTHER||||||<|0.001|||||||ANCOVA|These analyses apply to the Frontal, Central, and Central-Parietal regions.||||||<0.001
91740064|NCT04050384|183372178|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91740065|NCT04776161|183372186|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|95.0|-0.16|0.12|||Generalized linear models|Adjusted for age, sex, race||||0.12|-0.16|0.78
91740066|NCT04776161|183372186|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.79|TWO_SIDED|95.0|-0.1|0.13|||Generalized linear models|Adjusted for age, sex, race||||0.13|-0.10|0.79
91740067|NCT04776161|183372187|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.22|TWO_SIDED|95.0|-0.28|1.22|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level.||||1.22|-0.28|0.22
91740068|NCT04776161|183372187|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.24|TWO_SIDED|95.0|-0.33|1.26|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level||||1.26|-0.33|0.24
91740069|NCT01187095|183372188|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimation parameter|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91740070|NCT01187095|183372188|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
91740071|NCT02848092|183372202|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||.76|.52|<.0001
91740072|NCT02848092|183372203|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.29|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||-.13|-.29|<.0001
91740073|NCT02848092|183372204|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||.76|.52|<.0001
91499598|NCT03720470|182868965|OTHER||Difference in Percentage|-2.7|||||TWO_SIDED|95.0|-9.6|4.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||4.2|-9.6|
91499599|NCT03720470|182868965|OTHER||Difference in Percentage|3.1|||||TWO_SIDED|95.0|-3.3|9.6||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||9.6|-3.3|
91499600|NCT01988103|182868992|SUPERIORITY_OR_OTHER_LEGACY||Difference|16.4||||0.0032|TWO_SIDED|95.0|5.8|27.0|||Chi-squared|||||27.0|5.8|0.0032
91531148|NCT02584855|182938915|SUPERIORITY||Odds Ratio (OR)|-45.6|||||TWO_SIDED|95.0|-58.8|-32.3||||||Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .||-32.3|-58.8|
91740074|NCT02848092|183372205|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||-.13|-.31|<.0001
91740075|NCT02848092|183372206|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.41|0.89||||||||.89|.41|
91740076|NCT02848092|183372207|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.61|0.92||||||||.92|.61|
91740077|NCT01516632|183372231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.82|3.21||||||||3.21|.82|
91740078|NCT01516632|183372232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.22|5.3||||||||5.30|1.22|
91740079|NCT01516632|183372233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||||TWO_SIDED|95.0|1.48|7.45||||||||7.45|1.48|
91740080|NCT02831855|183372280|NON_INFERIORITY|Non-inferiority (NI) of Tofacitinib 11 mg + Methotrexate Placebo to Tofacitinib 11 mg + continued Methotrexate was concluded if the upper bound of 95% 2-sided confidence interval (CI) for difference between the 2 arms (Tofacitinib 11 mg + Methotrexate Placebo reporting arm - Tofacitinib 11 mg + continued Methotrexate arm) was lower than 0.6.|Least Square (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|0.12|0.48||The p-value is one-sided for the test against the NI margin of 0.6.|MMRM|||Linear mixed-effect model of repeated measures (MMRM) was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (bDMARD), and baseline DAS28-4 (ESR) value as a covariate.||0.48|0.12|0.0005
91740081|NCT02831855|183372281|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.03|0.41||||||Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (ESR) value as a covariate.||0.41|0.03|
91740082|NCT02831855|183372282|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.08|0.43||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.43|0.08|
91740083|NCT02831855|183372282|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.11|0.45||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.45|0.11|
91740084|NCT02831855|183372283|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.4|3.07||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.07|0.40|
91499601|NCT01988103|182868992|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.1||||0.0003|TWO_SIDED|95.0|10.1|32.1|||Chi-squared|||||32.1|10.1|0.0003
91499602|NCT01988103|182868993|SUPERIORITY_OR_OTHER_LEGACY||Difference|15.1||||0.0165|TWO_SIDED|95.0|3.1|27.1|||Chi-squared|||||27.1|3.1|0.0165
91531149|NCT02584855|182938918|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
91531150|NCT02584855|182938919|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
91740085|NCT02831855|183372283|SUPERIORITY||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|0.83|3.43||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.43|0.83|
91740086|NCT02831855|183372284|SUPERIORITY||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|0.53|3.37||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.37|0.53|
91740087|NCT02831855|183372284|SUPERIORITY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.86|3.59||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.59|0.86|
91740088|NCT02831855|183372285|SUPERIORITY||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.15|2.76||||||Week 36||2.76|-14.15|
91740089|NCT02831855|183372285|SUPERIORITY||Difference in percentage of participants|-4.54|||||TWO_SIDED|95.0|-13.04|3.94||||||Week 48||3.94|-13.04|
91740090|NCT02831855|183372286|SUPERIORITY||Difference in percentage of participants|-5.14|||||TWO_SIDED|95.0|-13.07|2.77||||||Week 36||2.77|-13.07|
91499603|NCT01988103|182868993|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.8||||0.002|TWO_SIDED|95.0|8.2|33.3|||Chi-squared||Missing values were imputed using the LOCF method.|||33.3|8.2|0.0020
91531151|NCT02584855|182938920|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
91531152|NCT02584855|182938921|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
91740091|NCT02831855|183372286|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-16.28|-0.76||||||Week 48||-0.76|-16.28|
91499604|NCT01988103|182868994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.1||||0.0003|TWO_SIDED|95.0|-44.5|-13.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-13.6|-44.5|0.0003
91499605|NCT01988103|182868994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.0|||<|0.0001|TWO_SIDED|95.0|-53.4|-22.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-22.6|-53.4|<0.0001
91499606|NCT01988103|182868995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.5||||0.0002|TWO_SIDED|95.0|-44.9|-14.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-14.0|-44.9|0.0002
91531153|NCT02584855|182938922|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
91531154|NCT00544544|182938931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<.001
91740092|NCT02831855|183372287|SUPERIORITY||Difference in percentage of participants|-7.39|||||TWO_SIDED|95.0|-15.17|0.38||||||Week 36||0.38|-15.17|
91740093|NCT02831855|183372287|SUPERIORITY||Difference in percentage of participants|-11.91|||||TWO_SIDED|95.0|-19.56|-4.26||||||Week 48||-4.26|-19.56|
91740094|NCT02831855|183372288|SUPERIORITY||Difference in percentage of participants|-7.02|||||TWO_SIDED|95.0|-14.81|0.77||||||Week 36||0.77|-14.81|
91740095|NCT02831855|183372288|SUPERIORITY||Difference in percentage of participants|-10.02|||||TWO_SIDED|95.0|-17.68|-2.37||||||Week 48||-2.37|-17.68|
91740096|NCT02831855|183372289|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-15.27|-1.78||||||Week 36||-1.78|-15.27|
91740097|NCT02831855|183372289|SUPERIORITY||Difference in percentage of participants|-1.33|||||TWO_SIDED|95.0|-8.5|5.83|||Two Sided|||Week 48||5.83|-8.50|
91499607|NCT01988103|182868995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.5|||<|0.0001|TWO_SIDED|95.0|-54.9|-24.1|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-24.1|-54.9|<0.0001
91499608|NCT01988103|182868996|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.7||||0.0057|TWO_SIDED|95.0|6.1|33.4|||Chi-squared|||||33.4|6.1|0.0057
91499609|NCT01988103|182868996|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.2|||<|0.0001|TWO_SIDED|95.0|15.4|42.9|||Chi-squared|||||42.9|15.4|<0.0001
91531155|NCT00544544|182938932|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91531156|NCT00544544|182938933|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mixed Models Analysis|||||||0.38
91740098|NCT02831855|183372290|SUPERIORITY||Difference in percentage of participants|-8.11|||||TWO_SIDED|95.0|-15.4|-0.82||||||Week 36||-0.82|-15.40|
91740099|NCT02831855|183372290|SUPERIORITY||Difference in percentage of participants|-6.21|||||TWO_SIDED|95.0|-13.74|1.32||||||Week 48||1.32|-13.74|
91740100|NCT02831855|183372291|SUPERIORITY||Difference in percentage of participants|-5.63|||||TWO_SIDED|95.0|-14.12|2.84||||||Week 36||2.84|-14.12|
91740101|NCT02831855|183372291|SUPERIORITY||Difference in percentage of participants|-4.13|||||TWO_SIDED|95.0|-12.62|4.36||||||Week 48||4.36|-12.62|
91740102|NCT02831855|183372292|SUPERIORITY||Difference in percentage of participants|-8.84|||||TWO_SIDED|95.0|-16.44|-1.24||||||Week 36||-1.24|-16.44|
91740103|NCT02831855|183372292|SUPERIORITY||Difference in percentage of participants|-2.41|||||TWO_SIDED|95.0|-10.18|5.35||||||Week 48||5.35|-10.18|
91740104|NCT02831855|183372293|SUPERIORITY||Difference in percentage of participants|-8.85|||||TWO_SIDED|95.0|-16.38|-1.31||||||Week 36||-1.31|-16.38|
91740105|NCT02831855|183372293|SUPERIORITY||Difference in percentage of participants|-3.16|||||TWO_SIDED|95.0|-10.99|4.65||||||Week 48||4.65|-10.99|
91740106|NCT02831855|183372294|SUPERIORITY||Difference in percentage of participants|-6.96|||||TWO_SIDED|95.0|-14.06|0.14||||||Week 36||0.14|-14.06|
91740107|NCT02831855|183372294|SUPERIORITY||Difference in percentage of participants|-6.59|||||TWO_SIDED|95.0|-13.8|0.61||||||Week 48||0.61|-13.80|
91740108|NCT02831855|183372295|SUPERIORITY||Difference in percentage of participants|-12.75|||||TWO_SIDED|95.0|-21.01|-4.48||||||Week 36||-4.48|-21.01|
91740109|NCT02831855|183372295|SUPERIORITY||Difference in percentage of participants|-11.99|||||TWO_SIDED|95.0|-20.22|-3.75||||||Week 48||-3.75|-20.22|
91499610|NCT01988103|182868997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6||||0.0003|TWO_SIDED|95.0|-22.6|-6.7|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-6.7|-22.6|0.0003
91531157|NCT00544544|182938934|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91531158|NCT03277378|182938948|NON_INFERIORITY|The hypothesis was tested at the 5% significance level.||||||0.0003|||||||Farrington- Manning non-inferioirty test|||"The hypothesis was formally addressed as:~H0: AB - TB ≤ -15% H1: AB - TB \> -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)"||||0.0003
91531159|NCT03277378|182938949|OTHER|||||||0.25|||||||Chi-squared|||"The hypothesis was formally addressed as:~H0: P ≤ 60% H1: P \> 60% where P= percentage of physician prefer anatomic placement over targeted placement.~The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level."||||0.2500
91531160|NCT02424344|182938973|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.125||||0.069|TWO_SIDED|95.0|-0.259|0.01|||ANCOVA|Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors||||0.010|-0.259|0.069
91531161|NCT04730947|182938976|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
91531162|NCT04730947|182938977|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
91531163|NCT04730947|182938978|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
91740110|NCT02831855|183372296|SUPERIORITY||Difference in percentage of participants|-5.37|||||TWO_SIDED|95.0|-13.63|2.89||||||Week 36||2.89|-13.63|
91740111|NCT02831855|183372296|SUPERIORITY||Difference in percentage of participants|-4.97|||||TWO_SIDED|95.0|-13.32|3.36||||||Week 48||3.36|-13.32|
91740112|NCT02831855|183372297|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.02|0.16||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.16|0.02|
91740113|NCT02831855|183372297|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.06|0.09||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.09|-0.06|
91740114|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.79|0.92||||||Change at Week 36: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||0.92|-1.79|
91740115|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-0.82|1.85||||||Change at Week 48: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||1.85|-0.82|
91740116|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.97|-0.37||||||Change at Week 36: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||-0.37|-2.97|
91740117|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.13|0.66||||||Change at Week 48: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||0.66|-2.13|
91740118|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.21||||||Change at Week 36: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||1.21|-1.50|
91740119|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.95|0.93||||||Change at Week 48: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||0.93|-1.95|
91740120|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.9|-0.01||||||Change at Week 36: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||-0.01|-2.90|
91740121|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.23|0.73||||||Change at Week 48: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||0.73|-2.23|
91740122|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.29|0.49||||||Change at Week 36: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||0.49|-2.29|
91740123|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.94|1.02||||||Change at Week 48: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||1.02|-1.94|
91740124|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.64|0.43||||||Change at Week 36: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||0.43|-2.64|
91740125|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.95|1.01||||||Change at Week 48: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||1.01|-1.95|
91740126|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.52|0.22||||||Change at Week 36: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.22|-2.52|
91740127|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.94|0.91||||||Change at Week 48: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.91|-1.94|
91740128|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.3|1.08||||||Change at Week 36: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.08|-1.30|
91531164|NCT04730947|182938979|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
91531165|NCT04730947|182938980|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91499611|NCT01988103|182868997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.7|-16.9|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate. Missing values were imputed using the LOCF method.|||-16.9|-32.7|<0.0001
91740129|NCT02831855|183372298|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.6|1.83||||||Change at Week 48: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.83|-0.60|
91740130|NCT02831855|183372299|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.01|0.37||||||Change at Week 36: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score- as a covariate.||0.37|-2.01|
91740131|NCT02831855|183372299|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.11|1.29||||||Change at Week 48: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (DMARD), and baseline SF-36 physical component score- as a covariate.||1.29|-1.11|
91740132|NCT02831855|183372299|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.13|0.49||||||Change at Week 36: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.49|-2.13|
91740133|NCT02831855|183372299|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.06|0.7||||||Change at Week 48: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.70|-2.06|
91740134|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-3.14|6.37||||||Change at Week 36: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||6.37|-3.14|
91740135|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-5.01|3.99||||||Change at Week 48: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||3.99|-5.01|
91740136|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|3.19|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-0.51|6.89||||||Change at Week 36: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||6.89|-0.51|
91740137|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-2.41|5.61||||||Change at Week 48: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||5.61|-2.41|
91740138|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-2.84|8.87||||||Change at Week 36: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||8.87|-2.84|
91740139|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-8.34|6.54||||||Change at Week 48: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||6.54|-8.34|
91499612|NCT01988103|182868998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0204|TWO_SIDED|95.0|-3.2|-0.3|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-0.3|-3.2|0.0204
91499613|NCT01988103|182868998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.9|-2.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-2.0|-4.9|<0.0001
91740140|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|2.84|STANDARD_ERROR_OF_MEAN|3.45|||TWO_SIDED|95.0|-3.97|9.65||||||Change at Week 36: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||9.65|-3.97|
91740141|NCT02831855|183372300|SUPERIORITY||LS Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-10.72|5.8||||||Change at Week 48: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||5.80|-10.72|
91740142|NCT02831855|183372301|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||-0.01|-0.07|
91740143|NCT02831855|183372301|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.06|0.01||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||0.01|-0.06|
91740144|NCT02831855|183372302|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.37|1.0||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.00|-1.37|
91740145|NCT02831855|183372302|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.07|1.44||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.44|-1.07|
91740146|NCT02831855|183372303|SUPERIORITY||Difference in percentage of participants|-10.02|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-17.61|-2.42||||||Week 36||-2.42|-17.61|
91499614|NCT01988103|182868999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.5149|TWO_SIDED|95.0|-1.78|3.53|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||3.53|-1.78|0.5149
91740147|NCT02831855|183372303|SUPERIORITY||Difference in percentage of participants|-6.62|STANDARD_ERROR_OF_MEAN|3.89|||TWO_SIDED|95.0|-14.26|1.0||||||Week 48||1.00|-14.26|
91740148|NCT01118780|183372314|SUPERIORITY_OR_OTHER||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|2.47|5.88|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||5.88|2.47|<0.001
91740149|NCT01118780|183372315|SUPERIORITY_OR_OTHER||LS mean difference|3.23|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|1.61|4.85|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||4.85|1.61|<0.001
91740150|NCT01118780|183372316|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|1.43|3.37||The p-value is for the change from baseline to Week 10 in the HAMA Psychic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.37|1.43|<0.001
91740151|NCT01118780|183372316|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|0.87|2.65||The p-value is for the change from baseline to Week 10 in the HAMA Somatic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.65|0.87|<0.001
91740152|NCT01118780|183372316|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.3|0.74||The p-value is for the change from baseline to Week 10 in the HAMA Anxious Mood Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.74|0.30|<0.001
91740153|NCT01118780|183372316|SUPERIORITY_OR_OTHER||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.11||0.007|TWO_SIDED|95.0|0.09|0.53||The p-value is for the change from baseline to Week 10 in the HAMA Tension Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.53|0.09|0.007
91740154|NCT01118780|183372317|SUPERIORITY_OR_OTHER||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.2|3.18||The p-value is for the change from baseline to Week 10 in the HADS Anxiety Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.18|1.20|<0.001
91740155|NCT01118780|183372317|SUPERIORITY_OR_OTHER||LS mean difference|1.69|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.89|2.49||The p-value is for the change from baseline to Week 10 in the HADS Depression Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.49|0.89|<0.001
91499615|NCT01988103|182868999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85||||0.1693|TWO_SIDED|95.0|-0.79|4.5|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||4.50|-0.79|0.1693
91499616|NCT02451839|182869012|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||< 0.001
91499617|NCT02451839|182869013|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91531166|NCT04730947|182938981|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
91740156|NCT01118780|183372318|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.26|0.79|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.79|0.26|<0.001
91740157|NCT01118780|183372319|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.33|0.91|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|0.33|<0.001
91499618|NCT02451839|182869014|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499619|NCT02451839|182869015|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499620|NCT02451839|182869016|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499621|NCT02451839|182869017|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499622|NCT02451839|182869018|SUPERIORITY|||||||0.015|||||||paired t-test|||||||0.015
91499623|NCT02451839|182869019|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499624|NCT02451839|182869020|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
91499625|NCT02451839|182869021|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91531167|NCT04730947|182938982|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
91531168|NCT04730947|182938983|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
91531169|NCT04730947|182938984|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||||||0.136
91740158|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.059|TWO_SIDED|95.0|-0.02|1.11||The p-value is for the change from baseline to Week 10 in BPI-SF Worst Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.11|-0.02|0.059
91740159|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.24||0.079|TWO_SIDED|95.0|-0.05|0.89||The p-value is for the change from baseline to Week 10 in BPI-SF Least Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.89|-0.05|0.079
91740160|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.089|TWO_SIDED|95.0|-0.06|0.91||The p-value is for the change from baseline to Week 10 in BPI-SF Average Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|-0.06|0.089
91740161|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.371|TWO_SIDED|95.0|-0.27|0.73||The p-value is for the change from baseline to Week 10 in BPI-SF Pain Right Now Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.73|-0.27|0.371
91499626|NCT02451839|182869022|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499627|NCT02451839|182869023|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
91740162|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.29||0.066|TWO_SIDED|95.0|-0.04|1.09||The p-value is for the change from baseline to Week 10 in BPI-SF General Activity Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.09|-0.04|0.066
91740163|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.41|STANDARD_ERROR_OF_MEAN|0.27||0.14|TWO_SIDED|95.0|-0.13|0.95||The p-value is for the change from baseline to Week 10 in BPI-SF Mood Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.95|-0.13|0.140
91740164|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.04|TWO_SIDED|95.0|0.03|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Walking Ability Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|0.03|0.040
91740165|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.29||0.187|TWO_SIDED|95.0|-0.19|0.94||The p-value is for the change from baseline to Week 10 in BPI-SF Normal Work Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.94|-0.19|0.187
91740166|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.26||0.515|TWO_SIDED|95.0|-0.34|0.68||The p-value is for the change from baseline to Week 10 in BPI-SF Relations With Other People Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.68|-0.34|0.515
91740167|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.34||0.141|TWO_SIDED|95.0|-0.17|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Sleep Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|-0.17|0.141
91740168|NCT01118780|183372320|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.088|TWO_SIDED|95.0|-0.07|1.07||The p-value is for the change from baseline to Week 10 in BPI-SF Enjoyment of Life Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.07|-0.07|0.088
91740169|NCT01118780|183372321|SUPERIORITY_OR_OTHER||LS mean difference|-5.76|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|-9.4|-2.1|||ANCOVA||LS mean difference was calculated by placebo minus duloxetine. Negative values indicated improvement over placebo.|||-2.1|-9.4|0.002
91740170|NCT01118780|183372323|SUPERIORITY_OR_OTHER||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.43||0.01|TWO_SIDED|95.0|0.27|1.98||The p-value is for the change from baseline to Week 10 in SDS for Work/School Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.98|0.27|0.010
91740171|NCT01118780|183372323|SUPERIORITY_OR_OTHER||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|0.32|1.48||The p-value is for the change from baseline to Week 10 in SDS for Social Life/Leisure Activities Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.48|0.32|0.002
91740172|NCT01118780|183372323|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.61|1.81||The p-value is for the change from baseline to Week 10 in SDS for Family/Home Management Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.81|0.61|<0.001
91740173|NCT01118780|183372324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having HAMA response at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
91740174|NCT01118780|183372324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤7) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
91499628|NCT02451839|182869024|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499629|NCT02451839|182869025|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499630|NCT02451839|182869026|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499631|NCT02451839|182869027|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
91499632|NCT01949051|182869087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.943|-0.756|||Mixed Model ANOVA|||||-0.756|-1.943|<0.0001
91499633|NCT01949051|182869087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118||||0.0003|TWO_SIDED|95.0|-1.712|-0.525|||Mixed Model ANOVA|||||-0.525|-1.712|0.0003
91531170|NCT03639675|182938989|OTHER||Mean change|-8.3||||0.0004|TWO_SIDED|95.0|-12.2|-4.4|||one-sample t-statistics|||||-4.4|-12.2|0.0004
91740175|NCT01118780|183372324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤10) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
91740176|NCT01118780|183372325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤5) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
91740177|NCT01118780|183372325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤6) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
91740178|NCT01118780|183372326|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement overall and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.001
91740179|NCT01118780|183372326|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement from Week 2 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.038
91499634|NCT01949051|182869087|NON_INFERIORITY_OR_EQUIVALENCE|Levocabastine OD would be declared as non-inferior to levocabastine BID if upper limit of 95% confidence interval of the treatment difference estimate (OD vs BD) was less than 1|Mean Difference (Final Values)|0.231|||||TWO_SIDED|95.0|-0.361|0.823||||||||0.823|-0.361|
91499635|NCT04483011|182869160|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.034|TWO_SIDED|||||\< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Dave 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.034
91499636|NCT04483011|182869160|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|2.79||0.265|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of Comparator.||||0.265
91740180|NCT01118780|183372330|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.005
91499637|NCT04483011|182869160|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.044|TWO_SIDED|||||\< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator groups.||||0.044
91499638|NCT04483011|182869161|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.008|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of RiaGev.||||0.008
91499639|NCT04483011|182869161|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_DEVIATION|1.34||0.297|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.297
91499640|NCT04483011|182869161|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.04|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.04
91499641|NCT04483011|182869162|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.004|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in the RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.004
91740181|NCT01118780|183372331|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the time to first remission (HAMA Total Score ≤10) and was adjusted for pooled investigator.|Log Rank|||||||<0.001
91740182|NCT01118780|183372332|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.001
91740183|NCT01118780|183372333|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The p-value is for the time to first functional remission (SDS Global Functional Impairment Score ≤5) and was adjusted for pooled investigator.|Log Rank|||||||0.006
91740184|NCT01118780|183372333|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The p-value is for time to first functional remission (SDS Global Functional Impairment Score ≤6) and was adjusted for pooled investigator.|Log Rank|||||||0.003
91740185|NCT01118780|183372334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||<0.001
91740186|NCT02020590|183372362|OTHER||||||||TWO_SIDED|90.0||||||||"The success of ALLOB® treatment was based on the percentage of responders. A treated patient was considered as responding if, at the end of the study (6 months):~* He/she had not required rescue surgery and~* The GDE score as perceived by the patient had improved by at least 25% or the TUS (tomographic union score) as assessed by CT scan had increased by at least 2 points."|The response rate at Month 6 for the 21 patients in the PP population was 100 % (CI: 86.71 - 100.0%). None of the treated patients required rescue surgery. An improvement of GDE score of at least 25% was reported for 16 (76.2%) patients. An increase in TUS of at least 2 points was reported for 16 (76.2%) patients; all patients met at least one of these two criteria.|||
91740187|NCT00527618|183372368|SUPERIORITY_OR_OTHER||Slope|-0.27|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||Mixed Models Analysis|Adjusted for baseline plasma HIV-1 RNA.|Acyclovir was coded as 0 and valacyclovir as 1. The beta-coefficient (slope) indicates the average difference in HIV-1 RNA on valacyclovir and acyclovir; a negative number indicates that plasma HIV-1 RNA was lower on valacyclovir than acyclovir.|We estimated that a sample size of 29 participants, with 4 weeks of weekly plasma HIV-1 RNA levels per treatment arm, would be required to detect a 0.25 log10 copies/ml difference in plasma HIV-1 RNA between the study arms with 80% power, at a two-sided type I error rate of 5%.||-0.14|-0.41|<0.001
91740188|NCT00527618|183372369|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.78|TWO_SIDED|95.0|0.66|1.37|||Random effects poission regression|Adjusted for age.||We estimated that 26 participants would be required to detect a 50% reduction in genital HSV shedding with 80% power, at a two-sided type I error rate of 5%.||1.37|0.66|0.78
91740189|NCT00527618|183372370|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91740190|NCT00527618|183372371|SUPERIORITY_OR_OTHER|||||||0.67|||||||Mixed Models Analysis|||||||0.67
91740191|NCT03141255|183372378|OTHER|||||||1|||||||Fisher Exact|||||||1
91740192|NCT03141255|183372379|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
91740193|NCT03141255|183372380|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91740194|NCT03141255|183372381|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91740195|NCT03141255|183372382|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
91740196|NCT03141255|183372383|SUPERIORITY|||||||0.091|||||||Mixed Models Analysis|||||||0.091
91740197|NCT03141255|183372384|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
91740198|NCT03141255|183372385|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
91740199|NCT03141255|183372386|SUPERIORITY|||||||0.516|||||||Fisher Exact|||||||0.516
91740200|NCT03141255|183372387|OTHER|||||||0.75|||||||Kaplan Meier|||||||0.75
91499642|NCT04483011|182869162|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|3.88||0.64|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.640
91740201|NCT03141255|183372388|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
91740202|NCT03141255|183372389|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
91740203|NCT01151020|183372401|SUPERIORITY_OR_OTHER_LEGACY||Free from major adverse event rate (%)|96.4|||<|0.001|TWO_SIDED|95.0|91.0|99.0|||Exact binomial test|||Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.||99|91|< 0.001
91740204|NCT01151020|183372402|SUPERIORITY_OR_OTHER_LEGACY||Device success rate (%)|92.7|||<|0.001|TWO_SIDED|95.0|86.2|96.8|||Exact binomial test|||Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.||96.8|86.2|< 0.001
91740205|NCT04419467|183372417|SUPERIORITY||GM % treatment difference (80% CI)|-0.5||||0.485|TWO_SIDED|80.0|-14.8|16.3||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.|||16.3|-14.8|0.485
91740206|NCT04419467|183372417|SUPERIORITY||GM % treatment difference (80% CI)|8.6||||0.75|TWO_SIDED|80.0|-7.2|27.2||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean, then expressed as percent treatment difference|||27.2|-7.2|0.750
91740207|NCT02967679|183372442|OTHER||Mean Difference (Net)|1.67|STANDARD_DEVIATION|11.45||0.7615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7615
91740208|NCT02967679|183372443|OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|8.89||0.5995|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5995
91740209|NCT02967679|183372444|OTHER||Mean Difference (Net)|4.8|STANDARD_DEVIATION|8.4||0.1641|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1641
91740210|NCT02967679|183372445|OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|16.5||0.0353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0353
91499643|NCT04483011|182869162|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.014|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.014
91499644|NCT04483011|182869163|SUPERIORITY||Mean Difference (Net)|-1037.92|STANDARD_DEVIATION|1590.74||0.013|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 is reported.|A comparison before and after RiaGev supplementation.||||0.013
91499645|NCT04483011|182869163|SUPERIORITY||Mean Difference (Net)|-302.08|STANDARD_DEVIATION|1427.42||0.382|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 is reported.|A comparison before before and after supplementation with Comparator.||||0.382
91499646|NCT04483011|182869164|SUPERIORITY||Mean Difference (Net)|-135.13|STANDARD_DEVIATION|2153.66||0.793|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 baseline is reported.|A comparison between before and after RiaGev supplementation||||0.793
91531171|NCT00826280|182939022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91531172|NCT00826280|182939022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91740211|NCT02967679|183372446|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.4||0.2642|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2642
91740212|NCT02967679|183372447|OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.2||0.1777|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1777
91740213|NCT02967679|183372448|OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|8.2||0.0371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0371
91740214|NCT02967679|183372449|OTHER||Mean Difference (Net)|-2.2|STANDARD_DEVIATION|2.9||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0142
91740215|NCT02967679|183372451|OTHER||Mean Difference (Net)|0.111|STANDARD_DEVIATION|0.201||0.1055|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1055
91740216|NCT02967679|183372452|OTHER||Mean Difference (Net)|9.84|STANDARD_DEVIATION|28.16||0.213|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2130
91740217|NCT02967679|183372453|OTHER||Mean Difference (Net)|0.068|STANDARD_DEVIATION|0.112||0.0393|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0393
91740218|NCT02967679|183372454|OTHER||Mean Difference (Net)|-5.905|STANDARD_DEVIATION|6.283||0.0004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0004
91740219|NCT02967679|183372455|OTHER||Mean Difference (Net)|-4.28|STANDARD_DEVIATION|32.21||0.3303|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3303
91740220|NCT02967679|183372456|OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.092||0.9229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9229
91740221|NCT00600067|183372460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.17||0.0381|TWO_SIDED|95.0|-0.69|-0.02|||ANCOVA|||||-0.02|-0.69|0.0381
91740222|NCT00600067|183372461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-9.18|-4.21|||ANCOVA|||||-4.21|-9.18|<0.0001
91740223|NCT04571060|183372486|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.5|13.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.1|4.5|<0.0001
91740224|NCT04571060|183372487|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.7||||0.0012|TWO_SIDED|95.0|3.4|13.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.9|3.4|0.0012
91740225|NCT04571060|183372488|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|9.0||||0.0012|TWO_SIDED|95.0|3.6|14.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.5|3.6|0.0012
91499647|NCT04483011|182869164|SUPERIORITY||Mean Difference (Net)|-134.79|STANDARD_DEVIATION|1830.16||0.758|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 baseline is reported.|A comparison between before and after supplementation with Comparator.||||0.758
91499648|NCT04483011|182869165|SUPERIORITY||Mean Difference (Net)|70.2|STANDARD_DEVIATION|123.89||0.003|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation||||0.003
91499649|NCT04483011|182869165|SUPERIORITY||Mean Difference (Net)|15.55|STANDARD_DEVIATION|88.62||0.766|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.766
91499650|NCT04483011|182869166|SUPERIORITY||Mean Difference (Net)|24.01|STANDARD_DEVIATION|58.2||0.029|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups after 7-day supplementation.||||0.029
91499651|NCT04483011|182869167|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_DEVIATION|0.32||0.034|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups.||||0.034
91499652|NCT04483011|182869168|SUPERIORITY||Mean Difference (Net)|-8.33|STANDARD_DEVIATION|12.99||0.014|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.014
91499653|NCT04483011|182869168|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_DEVIATION|5.66||0.049|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.049
91499654|NCT01454947|182869173|SUPERIORITY|||||||0.007||||||P values computed using difference between proportions (z value) with Bonferroni correction.|2 proportion Z-test|||||||0.007
91499655|NCT01025791|182869176|OTHER||0.1 mg vs. placebo|-7.06||||0.003|TWO_SIDED|90.0|-11.1|-3.0|||ANOVA|||||-3.00|-11.1|0.003
91499656|NCT01025791|182869176|OTHER||0.2 mg vs. placebo|-1.23||||0.31|TWO_SIDED|90.0|-5.42|2.96|||ANOVA|||||2.96|-5.42|0.310
91499657|NCT01025791|182869176|OTHER||0.5 mg vs. placebo|0.01||||0.498|TWO_SIDED|90.0|-4.05|4.06|||ANOVA|||||4.06|-4.05|0.498
91499658|NCT01025791|182869176|OTHER||1 mg vs. placebo|-5.69||||0.012|TWO_SIDED|90.0|-9.74|-1.63|||ANOVA|||||-1.63|-9.74|0.012
91499659|NCT01025791|182869176|OTHER||1 mg + 0.8 mg vs. placebo|-3.97||||0.059|TWO_SIDED|90.0|-8.16|0.22|||ANOVA|||||0.22|-8.16|0.059
91499660|NCT01025791|182869176|OTHER||0.4 mg vs. placebo|2.22||||0.191|TWO_SIDED|90.0|-2.09|6.54|||ANOVA|||||6.54|-2.09|0.191
91740226|NCT04571060|183372489|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2||||0.0001|TWO_SIDED|95.0|5.0|15.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.5|5.0|0.0001
91740227|NCT04571060|183372490|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.6||||0.0048|TWO_SIDED|95.0|2.3|12.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||12.9|2.3|0.0048
91740228|NCT04571060|183372491|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.5||||0.013|TWO_SIDED|95.0|1.4|11.7||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.7|1.4|0.0130
91740229|NCT04571060|183372492|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.9||||0.0076|TWO_SIDED|95.0|1.3|8.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||8.5|1.3|0.0076
91740230|NCT04571060|183372493|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|3.7||||0.0308|TWO_SIDED|95.0|0.3|7.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.1|0.3|0.0308
91499661|NCT01025791|182869176|OTHER||1.2 mg vs. placebo|1.24||||0.333|TWO_SIDED|90.0|-3.67|6.15|||ANOVA|||||6.15|-3.67|0.333
91499662|NCT01025791|182869176|OTHER||1.2 mg + 0.6 mg vs. placebo|-1.43||||0.314|TWO_SIDED|90.0|-6.5|3.63|||ANOVA|||||3.63|-6.50|0.314
91499663|NCT01025791|182869176|OTHER||1 mg + 0.8 mg vs. placebo|-9.31||||0.001|TWO_SIDED|90.0|-14.2|-4.37|||ANOVA|||||-4.37|-14.2|0.001
91499664|NCT01025791|182869176|OTHER||1.2 mg + 1.0 mg vs. placebo|-6.45||||0.017|TWO_SIDED|90.0|-11.4|-1.51|||ANOVA|||||-1.51|-11.4|0.017
91499665|NCT01025791|182869176|OTHER||1.0 mg + 0.6 mg + 0.6 mg vs. placebo|-9.96||||0.001|TWO_SIDED|90.0|-14.9|-5.02|||ANOVA|||||-5.02|-14.9|0.001
91740231|NCT04571060|183372494|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.3||||0.0123|TWO_SIDED|95.0|1.8|14.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.9|1.8|0.0123
91740232|NCT04571060|183372495|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.6||||0.0018|TWO_SIDED|95.0|3.2|14.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.1|3.2|0.0018
91740233|NCT04571060|183372496|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.0||||0.0293|TWO_SIDED|95.0|0.6|11.4||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.4|0.6|0.0293
91740234|NCT04571060|183372497|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.7||||0.0362|TWO_SIDED|95.0|0.3|9.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||9.1|0.3|0.0362
91740235|NCT04571060|183372498|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2|||<|0.0001|TWO_SIDED|95.0|5.5|15.0||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.0|5.5|<0.0001
91740236|NCT04571060|183372499|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.4||||0.0059|TWO_SIDED|95.0|1.3|7.6||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.6|1.3|0.0059
91740237|NCT04571060|183372500|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.2|11.3||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.3|4.2|<0.0001
91740238|NCT02765399|183372564|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91740239|NCT02765399|183372564|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91740240|NCT02765399|183372565|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91740241|NCT02765399|183372565|OTHER|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
91740242|NCT02765399|183372566|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91740243|NCT02765399|183372566|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
91740244|NCT02765399|183372567|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91740245|NCT02765399|183372567|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
91740246|NCT02765399|183372568|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91740247|NCT02765399|183372568|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||||||0.865
91740248|NCT02765399|183372569|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
91740249|NCT02765399|183372569|OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
91740250|NCT02765399|183372570|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
91740251|NCT02765399|183372570|OTHER|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||||||0.753
91740252|NCT02765399|183372571|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
91740253|NCT02765399|183372571|OTHER|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||0.499
91740254|NCT02765399|183372572|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91740255|NCT02765399|183372572|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
91740256|NCT02765399|183372573|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
91740257|NCT02765399|183372573|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
91740258|NCT02765399|183372574|OTHER|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
91740259|NCT02765399|183372574|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
91740260|NCT02765399|183372575|OTHER|||||||0.173|||||||Wilcoxon (Mann-Whitney)|||||||0.173
91740261|NCT02765399|183372575|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
91740262|NCT02765399|183372576|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91740263|NCT02765399|183372576|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91740264|NCT02765399|183372577|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91740265|NCT02765399|183372577|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91740266|NCT02765399|183372578|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91740267|NCT02765399|183372578|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91740268|NCT02765399|183372579|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91740269|NCT02765399|183372579|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91740270|NCT02765399|183372580|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91740271|NCT02765399|183372580|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91740272|NCT02765399|183372581|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91740273|NCT02765399|183372581|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91740274|NCT02765399|183372582|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
91740275|NCT02765399|183372582|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91740276|NCT02765399|183372583|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
91740277|NCT02765399|183372583|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91740278|NCT02765399|183372584|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
91740279|NCT02765399|183372584|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91740280|NCT03958331|183372592|SUPERIORITY||Mean Difference (Final Values)|10.62|STANDARD_ERROR_OF_MEAN|3.38||0.002|TWO_SIDED|95.0|4.0|17.25|||ANCOVA|Model controlled for baseline adherence, resistance to peer influence, dose, active seizures, COVID timing, COVID Impact (3 items), and sex|||We also conducted a longitudinal mixed effects model for adherence over time, estimating a groupXtime interaction with the same covariates listed above and allowing for a non-linear effect.|17.25|4|0.002
91740281|NCT02030821|183372614|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91740282|NCT02030821|183372615|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91740283|NCT02030821|183372616|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91740284|NCT02030821|183372617|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91740285|NCT03192137|183372619|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.||||||0.0005||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with anterior chamber cells Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||0.0005
91740286|NCT03192137|183372620|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.217|||<|0.0001|TWO_SIDED|95.0|1.823|5.675||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||5.675|1.823|<0.0001
91499666|NCT01025791|182869176|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|-9.0||||0.002|TWO_SIDED|95.0|-13.8|-4.17|||ANOVA|||||-4.17|-13.8|0.002
91740287|NCT03192137|183372620|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.337|||<|0.0001|TWO_SIDED|95.0|2.305|8.161||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||8.161|2.305|<0.0001
91740288|NCT03192137|183372620|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.113|8.033||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||8.033|2.113|<0.0001
91740289|NCT03192137|183372620|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.58||||0.0043|TWO_SIDED|95.0|1.38|4.822||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||4.822|1.380|0.0043
91740290|NCT03192137|183372620|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.277||||0.0005|TWO_SIDED|95.0|1.695|6.335||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||6.335|1.695|0.0005
91740291|NCT01152437|183372621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.122||||0.0735|TWO_SIDED|90.0|0.018|0.844||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Regression, Logistic|Wald Chi-square test and Confidence Interval from logistic regression stratified by number of lines of palliative chemotherapy.||Null hypothesis is that the objective response rate (ORR) in KRAS wild-type patients treated with afatinib is less than or equal to the ORR in KRAS wild-type patients treated with cetuximab. Sample size is based on a 'pick the winner' approach assuming ORR for cetuximab of 12%, undesirable ORR for afatinib of 11% and desirable ORR for afatinib of 16%. As per 'pick the winner' approach, afatinib would be considered 'the winner' if the ORR for afatinib was greater than the ORR for cetuximab.||0.844|0.018|0.0735
91740292|NCT01152437|183372622|SUPERIORITY_OR_OTHER||Percentage of participants|12.0||||0.6394|TWO_SIDED|90.0|4.9|23.9||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Exact binomial test|||Null hypothesis is that the disease control rate is 10% in patients with KRAS mutation. Sample size calculation based on a 2-sided exact binomial test at 10% significance level to distinguish between the historical disease control rate of 10% and a desirable disease control rate for afatinib of 25%.||23.9|4.9|0.6394
91740293|NCT01897532|183372633|NON_INFERIORITY|The non-inferiority margin was chosen as 1.3 (FDA Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes).|Hazard Ratio (HR)|1.02||||0.0002|TWO_SIDED|95.0|0.89|1.17||p-value for Hazard ratio (HR) ≥1.3 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.0002
91740294|NCT01897532|183372633|OTHER||Hazard Ratio (HR)|1.02||||0.6301|TWO_SIDED|95.0|0.89|1.17||p-value for HR ≥1.0 (1-sided).|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.6301
91740295|NCT01897532|183372634|OTHER||Hazard Ratio (HR)|1.04||||0.6918|TWO_SIDED|95.0|0.89|1.22||p-value for HR ≥1.0 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.22|0.89|0.6918
91740296|NCT01088906|183372654|SUPERIORITY||Odds Ratio (OR)|34.0||||0.05|TWO_SIDED||||||Regression, Logistic|||||||0.05
91740297|NCT03366454|183372679|OTHER||AUC|0.6692|STANDARD_ERROR_OF_MEAN|0.05322||0.0048|TWO_SIDED|95.0|0.5649|0.7735|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7735|0.5649|0.0048
91499667|NCT01025791|182869181|OTHER||GMR (Fed/Fasted)|0.89|||||TWO_SIDED|95.0|0.86|0.92||||||||0.92|0.86|
91499668|NCT01025791|182869182|OTHER||GMR (Fed/fasted)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
91499669|NCT01025791|182869183|OTHER||0.1 mg vs placebo|-0.53||||0.396|TWO_SIDED|90.0|-3.92|2.86|||ANOVA|||||2.86|-3.92|0.396
91499670|NCT01025791|182869183|OTHER||0.2 mg vs. placebo|2.33||||0.1329|TWO_SIDED|90.0|-1.17|5.83|||ANOVA|||||5.83|-1.17|0.1329
91499671|NCT01025791|182869183|OTHER||0.5mg vs. placebo|-2.96||||0.0741|TWO_SIDED|90.0|-6.35|0.43|||ANOVA|||||0.43|-6.35|0.0741
91740298|NCT03366454|183372679|OTHER||AUC|0.6892|STANDARD_ERROR_OF_MEAN|0.05213||0.0029|TWO_SIDED|95.0|0.587|0.7914|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7914|0.5870|0.0029
91740299|NCT03366454|183372680|OTHER||AUC|0.644|STANDARD_ERROR_OF_MEAN|0.05635||0.0233|TWO_SIDED|95.0|0.5335|0.7544|||ROC Curve Analysis||The optimal cutoff value for NLR was determined as 1.335 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7544|0.5335|0.0233
91740300|NCT03366454|183372681|OTHER||AUC|0.6884|STANDARD_ERROR_OF_MEAN|0.04709||0.0018|TWO_SIDED|95.0|0.5962|0.7807|||ROC Curve Analysis||The optimal cut-off value for CRP was determined as 5.70 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7807|0.5962|0.0018
91740301|NCT03366454|183372682|OTHER||AUC|0.7063|STANDARD_ERROR_OF_MEAN|0.04857||0.0007|TWO_SIDED|95.0|0.6111|0.8015|||ROC Curve Analysis||The optimal cutoff value for PCT was determined as 0.141 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.8015|0.6111|0.0007
91740302|NCT01639469|183372734|SUPERIORITY||Incidence Rate Ratio|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.68|||Negative Binomial Regression|||Testing to see if there is a significant difference in fall rates over 12months between the two groups.||0.68|0.22|<0.001
91740303|NCT00913510|183372735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0||||1||||||The p-value is calculated to the fourth decimal place.|Wilcoxon (Mann-Whitney)|||"H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power."||||1.0000
91740304|NCT01119443|183372736|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.2|||||TWO_SIDED|90.0|98.3|110.3|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.3|98.3|
91740305|NCT01119443|183372737|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.8||||||90.0|100.1|109.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.8|100.1|
91740306|NCT01119443|183372738|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|108.31|||||TWO_SIDED|90.0|95.634|122.676|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.676|95.634|
91740307|NCT01119443|183372739|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|106.85|||||TWO_SIDED|90.0|93.189|122.251|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.251|93.189|
91740308|NCT01119443|183372740|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|98.426|||||TWO_SIDED|90.0|84.276|112.58|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.58|84.276|
91499672|NCT01025791|182869183|OTHER||1 mg vs. placebo|7.08|||<|0.001|TWO_SIDED|90.0|3.69|10.47|||ANOVA|||||10.47|3.69|<0.001
91740309|NCT01119443|183372741|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|95.11|||||TWO_SIDED|90.0|82.461|109.698|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.698|82.461|
91740310|NCT01119443|183372743|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.07|||||TWO_SIDED|90.0|91.585|118.263|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||118.263|91.585|
91740311|NCT01119443|183372744|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|93.6||||||90.0|86.9|100.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.8|86.9|
91499673|NCT01025791|182869183|OTHER||1 mg + 0.8 mg vs. placebo|4.39||||0.0211|TWO_SIDED|90.0|0.89|7.09|||ANOVA|||||7.09|0.89|0.0211
91499674|NCT01025791|182869183|OTHER||0.4 mg vs. placebo|0.85||||0.399|TWO_SIDED|90.0|-4.79|6.48|||ANOVA|||||6.48|-4.79|0.399
91499675|NCT01025791|182869183|OTHER||1.2 mg vs. placebo|4.54||||0.1|TWO_SIDED|90.0|-1.94|11.02|||ANOVA|||||11.02|-1.94|0.100
91499676|NCT01025791|182869183|OTHER||1.2 mg + 0.6 mg vs. placebo|3.38||||0.195|TWO_SIDED|90.0|-3.29|10.06|||ANOVA|||||10.06|-3.29|0.195
91499677|NCT01025791|182869183|OTHER||1.0 mg + 0.8 mg vs. placebo|9.16||||0.022|TWO_SIDED|90.0|1.74|16.58|||ANOVA|||||16.58|1.74|0.022
91740312|NCT01119443|183372745|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|100.2|||||TWO_SIDED|90.0|94.0|106.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.7|94.0|
91740313|NCT01119443|183372746|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
91740314|NCT01119443|183372747|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
91740315|NCT01119443|183372748|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|99.069|||||TWO_SIDED|90.0|80.688|117.45|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||117.45|80.688|
91740316|NCT01119443|183372749|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|109.48|||||TWO_SIDED|90.0|89.571|133.811|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||133.811|89.571|
91740317|NCT01119443|183372751|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|92.63|||||TWO_SIDED|90.0|77.871|110.185|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.185|77.871|
91740318|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.049||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.||||0.0490
91740319|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.19||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
91740320|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.0017||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0017
91499678|NCT01025791|182869183|OTHER||1.2 mg + 1.0 mg vs. placebo|5.74||||0.098|TWO_SIDED|90.0|-1.68|13.16|||ANOVA|||||13.16|-1.68|0.098
91499679|NCT01025791|182869183|OTHER||1 mg + 0.6 mg + 0.6 mg vs. placebo|3.48||||0.214|TWO_SIDED|90.0|-3.94|10.9|||ANOVA|||||10.90|-3.94|0.214
91499680|NCT01025791|182869183|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|4.24||||0.163|TWO_SIDED|95.0|-3.03|11.52|||ANOVA|||||11.52|-3.03|0.163
91740321|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.0092||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0092
91740322|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.45||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.45
91740323|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.18
91740324|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.47||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.47
91740325|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.0423||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0423
91740326|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.15||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.15
91740327|NCT01665911|183372789|SUPERIORITY_OR_OTHER|||||||0.54||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.54
91740328|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.24||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.24
91740329|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.17||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.17
91740330|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.0008||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0008
91740331|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.0003||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0003
91740332|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.24||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.24
91740333|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.26||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.26
91740334|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.18
91740335|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.0269||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0269
91740336|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.0142||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0142
91740337|NCT01665911|183372790|SUPERIORITY_OR_OTHER|||||||0.81||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.81
91740338|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.0000
91740339|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
91740340|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
91740341|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
91740342|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0.14||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.14
91740343|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0.0012||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0012
91740344|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0.19||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
91740345|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
91740346|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0.0075||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0075
91740347|NCT01665911|183372791|SUPERIORITY_OR_OTHER|||||||0.0444||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0444
91740348|NCT01881009|183372809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91740349|NCT01881009|183372810|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91740350|NCT01718522|183372812|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91740351|NCT01718522|183372813|OTHER|||||||0.12|||||||Wilcoxon Signed-Rank Test|||||||0.12
91740352|NCT01718522|183372814|OTHER|||||||0.3|||||||Wilcoxon Signed-Rank Test|||||||0.30
91740353|NCT01718522|183372815|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
91740354|NCT01718522|183372816|OTHER|||||||0.04|||||||Wilcoxon Signed-Rank Test|||||||0.04
91740355|NCT01718522|183372817|OTHER|||||||0.35|||||||Wilcoxon Signed-Rank Test|||||||0.35
91740356|NCT01718522|183372818|OTHER|||||||0.001|||||||Wilcoxon Signed-Rank Test|||||||0.001
91740357|NCT01718522|183372819|OTHER|||||||0.61|||||||Wilcoxon Signed-Rank Test|||||||0.61
91740358|NCT01718522|183372820|OTHER|||||||0.1|||||||Wilcoxon Signed-Rank Test|||||||0.1
91740359|NCT01718522|183372821|OTHER|||||||0.22|||||||Wilcoxon Signed-Rank Test|||||||0.22
91740360|NCT00889707|183372844|SUPERIORITY_OR_OTHER|||||||0.04||||||Test of superiority computed using an ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume. Tested for 2-sided 0.05 level of statistical significance.|ANCOVA|ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume.||||||0.040
91740361|NCT00889707|183372845|SUPERIORITY_OR_OTHER|||||||0.047||||||ANCOVA model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|ANCOVA|Model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.||||||0.047
91740362|NCT03502915|183372851|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.053|STANDARD_DEVIATION|2.508||0.943|TWO_SIDED|95.0|-1.402|1.507|||t-test, 2 sided|||||1.507|-1.402|0.943
91740363|NCT03502915|183372852|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.443|STANDARD_DEVIATION|2.867||0.597|TWO_SIDED|95.0|-1.229|2.114|||t-test, 2 sided|||||2.114|-1.229|0.597
91740364|NCT03502915|183372853|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|1.28||0.748|TWO_SIDED|95.0|-0.629|0.869|||t-test, 2 sided|||||0.869|-0.629|0.748
91740365|NCT03502915|183372854|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|-2.634|STANDARD_DEVIATION|3.816||0.025|TWO_SIDED|95.0|-4.927|-0.341|||t-test, 2 sided|||||-0.341|-4.927|0.025
91740366|NCT03502915|183372855|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.056|STANDARD_DEVIATION|2.742||0.944|TWO_SIDED|95.0|-1.543|1.655|||t-test, 2 sided|||||1.655|-1.543|0.944
91740367|NCT00881894|183372856|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9864||||||90.0|0.9103|1.0688|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0688|0.9103|
91740368|NCT00881894|183372857|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9584||||||90.0|0.8861|1.0367|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0367|0.8861|
91740369|NCT00881894|183372858|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9896||||||90.0|0.9179|1.0671|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).||Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0671|0.9179|
91740370|NCT01361217|183372869|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91740371|NCT01361217|183372869|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91740372|NCT01361217|183372870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91499681|NCT02237950|182869241|SUPERIORITY|||||||0.015|||||||Regression, Logistic|||||||0.015
91740373|NCT00437268|183372901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.431||||||The type 1 error rate was set at 0.20|Log Rank|||||||0.431
91740374|NCT00437268|183372902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593|||||||Fisher Exact|||||||0.593
91740375|NCT00437268|183372903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Log Rank|||||||0.157
91740376|NCT00437268|183372904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||Kaplan-Meier analysis was used for statistical analysis.|Log Rank|||||||0.539
91740377|NCT00437268|183372905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.695|||||||Fisher Exact|||||||0.695
91740378|NCT04417257|183372916|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.7377|TWO_SIDED|95.0|-15.0|9.0||one-sided (right tailed)|Fisher Exact||A positive difference favours LAU-7b, a negative difference favours placebo.|Participants with health status data missing on Day 29 were treated as non-responders, where a non-responder was defined as not reaching a health status of 1-4.||9|-15|0.7377
91499682|NCT02237950|182869242|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
91499683|NCT02237950|182869243|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||||||0.002
91499684|NCT02237950|182869244|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
91499685|NCT02237950|182869245|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
91499686|NCT02237950|182869246|SUPERIORITY|||||||0.059|||||||Regression, Logistic|||||||0.059
91499687|NCT02237950|182869247|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
91499688|NCT01896531|182869250|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.12|||=|0.56|TWO_SIDED|90.0|0.81|1.55|||Log Rank|||All randomized participants||1.55|0.81|= 0.56
91499689|NCT01896531|182869250|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.07|||=|0.86|TWO_SIDED|90.0|0.54|2.11|||Log Rank|||Participants with PTEN loss tumors||2.11|0.54|= 0.86
91499690|NCT01896531|182869251|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.52|||=|0.0234|TWO_SIDED|90.0|1.12|2.07|||Log Rank|||All randomized participants||2.07|1.12|= 0.0234
91499691|NCT01896531|182869251|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.2867|TWO_SIDED|90.0|0.75|3.65|||Log Rank|||Participants with PTEN loss tumors||3.65|0.75|= 0.2867
91499692|NCT01896531|182869251|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.1369|TWO_SIDED|90.0|0.94|2.93|||Log Rank|||Participants who are Akt Dx+||2.93|0.94|= 0.1369
91499693|NCT01896531|182869252|SUPERIORITY||Difference in Response Rates|-5.2|||=|0.5202|TWO_SIDED|90.0|-18.46|8.06|||Cochran-Mantel-Haenszel|||All randomized participants||8.06|-18.46|= 0.5202
91499694|NCT01896531|182869252|SUPERIORITY||Difference in Response Rates|-23.33|||=|0.2035|TWO_SIDED|90.0|-52.24|5.58|||Cochran-Mantel-Haenszel|||Participants with PTEN loss tumors||5.58|-52.24|= 0.2035
91740379|NCT04417257|183372916|SUPERIORITY||Mean Difference (Final Values)|-3.0||||1|TWO_SIDED|95.0|-10.0|2.8||one-sided (right tailed)|Fisher Exact||A positive difference favours LAU-7b, a negative difference favours placebo.|Participants from Per-Protocol population and with available Day 29 health status data||2.8|-10.0|1.000
91499695|NCT01896531|182869252|SUPERIORITY||Difference in Response Rates|-4.35|||=|0.7697|TWO_SIDED|90.0|-28.48|19.79|||Cochran-Mantel-Haenszel|||Participants who are Akt Dx+||19.79|-28.48|= 0.7697
91499696|NCT01896531|182869253|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.14|||=|0.5974|TWO_SIDED|90.0|0.76|1.73|||Log Rank|||All randomized participants||1.73|0.76|= 0.5974
91499697|NCT01896531|182869253|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.71|||=|0.5385|TWO_SIDED|90.0|0.28|1.79|||Log Rank|||Participants with PTEN loss tumors||1.79|0.28|= 0.5385
91499698|NCT01896531|182869253|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.78|||=|0.6097|TWO_SIDED|90.0|0.35|1.75|||Log Rank|||Participants who are Akt Dx+||1.75|0.35|= 0.6097
91499699|NCT05185089|182869256|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.305||0.989|TWO_SIDED|95.0|-0.62|0.63|||ANCOVA|||||0.63|-0.62|0.989
91499700|NCT05185089|182869256|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.293||0.054|TWO_SIDED|95.0|-1.16|0.01|||ANCOVA|||||0.01|-1.16|0.054
91499701|NCT05185089|182869257|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.28||0.872|TWO_SIDED|95.0|-0.52|0.62|||ANCOVA|||||0.62|-0.52|0.872
91499702|NCT05185089|182869257|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.276||0.041|TWO_SIDED|95.0|-1.14|-0.02|||ANCOVA|||||-0.02|-1.14|0.041
91499703|NCT05185089|182869258|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.303||0.991|TWO_SIDED|95.0|-0.61|0.6|||ANCOVA|||||0.60|-0.61|0.991
91499704|NCT05185089|182869258|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.298||0.215|TWO_SIDED|95.0|-0.97|0.22|||ANCOVA|||||0.22|-0.97|0.215
91499705|NCT05185089|182869259|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.291||0.639|TWO_SIDED|95.0|-0.73|0.45|||ANCOVA|||||0.45|-0.73|0.639
91499706|NCT05185089|182869259|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.271||0.092|TWO_SIDED|95.0|-1.0|0.08|||ANCOVA|||||0.08|-1.00|0.092
91499707|NCT05185089|182869260|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.104||0.65|TWO_SIDED|95.0|-0.17|0.26|||ANCOVA|||||0.26|-0.17|0.650
91499708|NCT05185089|182869260|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.085||0.01|TWO_SIDED|95.0|-0.41|-0.06|||ANCOVA|||||-0.06|-0.41|0.010
91499709|NCT05185089|182869261|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.856|TWO_SIDED|95.0|-0.44|0.53|||ANCOVA|||||0.53|-0.44|0.856
91499710|NCT05185089|182869261|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.21||0.036|TWO_SIDED|95.0|-0.87|-0.03|||ANCOVA|||||-0.03|-0.87|0.036
91499711|NCT05185089|182869262|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.462||0.678|TWO_SIDED|95.0|-0.73|1.11|||ANCOVA|||||1.11|-0.73|0.678
91499712|NCT05185089|182869262|SUPERIORITY||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.525||0.025|TWO_SIDED|95.0|0.16|2.31|||ANCOVA|||||2.31|0.16|0.025
91499713|NCT05185089|182869263|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.143||0.633|TWO_SIDED|95.0|-0.22|0.35|||ANCOVA|||||0.35|-0.22|0.633
91499714|NCT05185089|182869263|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.139||0.063|TWO_SIDED|95.0|-0.02|0.56|||ANCOVA|||||0.56|-0.02|0.063
91499715|NCT05185089|182869264|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.185||0.732|TWO_SIDED|95.0|-0.44|0.31|||ANCOVA|||||0.31|-0.44|0.732
91499716|NCT05185089|182869264|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.214||0.044|TWO_SIDED|95.0|0.01|0.89|||ANCOVA|||||0.89|0.01|0.044
91499717|NCT05185089|182869265|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.19||0.318|TWO_SIDED|95.0|-0.19|0.58|||ANCOVA|||||0.58|-0.19|0.318
91499718|NCT05185089|182869265|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.228||0.03|TWO_SIDED|95.0|0.05|0.98|||ANCOVA|||||0.98|0.05|0.030
91499719|NCT05185089|182869266|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.08|STANDARD_ERROR_OF_MEAN|1.105||0.438|TWO_SIDED|95.0|0.88|1.33|||ANCOVA|||||1.33|0.88|0.438
91499720|NCT05185089|182869266|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.04|STANDARD_ERROR_OF_MEAN|1.122||0.761|TWO_SIDED|95.0|0.82|1.31|||ANCOVA|||||1.31|0.82|0.761
91531173|NCT00826280|182939022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91740380|NCT04417257|183372916|OTHER||Odds Ratio (OR)|0.57||||0.0177|TWO_SIDED|95.0|0.359|0.907||À priori threshold for statistical significance is set at 0.1|Regression, Logistic|"This P-value is for the baseline factor Health Status at baseline. Other baseline factors not significant."||Multivariable logistic regression was constructed for the proportion of participants alive and free of respiratory failure on Day 29 as the outcome variable by screening baseline covariates using stepwise technique with an alpha of 0.1 as the entry and stay criterion, and treatment group was forced to remain in the model. Health status at baseline was used as a continuous variable||0.907|0.359|0.0177
91740381|NCT04417257|183372916|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.3537|TWO_SIDED|95.0|-10.2|18.2||One-sided (right tailed)|Fisher Exact||A positive difference favours LAU-7b, a negative difference favours placebo.|Participants in the ITT population with baseline Health Status of 3 + 4 grouped together with imputation of failure for missing Day 29 data||18.2|-10.2|0.3537
91740382|NCT04417257|183372916|SUPERIORITY||Mean Difference (Final Values)|-16.2||||0.959|TWO_SIDED|95.0|-36.6|5.4||one-sided (right tailed)|Fisher Exact||A positive difference favours LAU-7b, a negative difference favours placebo.|Participants in the ITT population with baseline Health Status of 5 and imputation of failure for missing Day 29 data||5.4|-36.6|0.9590
91740383|NCT04417257|183372916|SUPERIORITY||Mean Difference (Final Values)|6.9||||0.0553|TWO_SIDED|95.0|0.4|17.1||one-sided (right tailed)|Fisher Exact||A positive difference favours LAU-7b, a negative difference favours placebo.|Participants in the ITT population with baseline Health Status of 3 + 4 and available Day 29 health status data (no imputation)||17.1|0.4|0.0553
91740384|NCT04417257|183372917|SUPERIORITY||Mean Difference (Net)|2.7||||0.66|TWO_SIDED|95.0|-6.9|13.9||Two-sided test|Fisher Exact||A negative difference favours LAU-7b, a positive difference favours placebo.|ITT population with Day 60 health status/survival data||13.9|-6.9|0.6600
91740385|NCT04417257|183372917|SUPERIORITY||Mean Difference (Net)|0.5||||1|TWO_SIDED|95.0|-10.6|12.6||Two-sided test|Fisher Exact||A negative difference favours LAU-7b, a positive difference favours placebo.|Per-Protocol population with Day 60 health status/survival data||12.6|-10.6|1.000
91740386|NCT04417257|183372920|SUPERIORITY|||||||0.5459||||||two-sided test|Wilcoxon (Mann-Whitney)|||ITT population, Day 14. The proportional odds assumption of the ordinal logistic regression was not met (P-value of Score test = 0.0180) and a Wilcoxon two sample test was performed.||||0.5459
91740387|NCT04417257|183372920|SUPERIORITY|||||||0.6229||||||two-sided test|Wilcoxon (Mann-Whitney)|||ITT population, Day 29. The proportional odds assumption of the ordinal logistic regression was not met (P-value \<.0001) and a Wilcoxon two sample test was performed.||||0.6229
91740388|NCT04417257|183372921|SUPERIORITY|||||||0.8222||||||two-sided test|Fisher Exact|||Total number of participants in the overall ITT population who had the event prior to or with Day 29 assessment available.||||0.8222
91740389|NCT04417257|183372921|SUPERIORITY|||||||0.0536||||||two-sided test|Fisher Exact|||Total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 29 assessment available.||||0.0536
91740390|NCT04417257|183372921|SUPERIORITY|||||||0.1131||||||two-sided test|Fisher Exact|||Total number of participants with Health Status 5 at baseline who had the event prior to or with Day 29 assessment available.||||0.1131
91740391|NCT04417257|183372923|SUPERIORITY|||||||0.6689||||||two-sided test|Fisher Exact|||Total number of participants in the overall ITT population who had the event prior to or with Day 60 assessment available.||||0.6689
91740392|NCT04417257|183372923|SUPERIORITY|||||||0.0536||||||two-sided test|Fisher Exact|||Total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available.||||0.0536
91740393|NCT04417257|183372923|SUPERIORITY|||||||0.0786||||||two-sided test|Fisher Exact|||Total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available.||||0.0786
91740394|NCT04417257|183372925|SUPERIORITY|Two-sided test||||||1|||||||Fisher Exact|||||||1.000
91740395|NCT04417257|183372926|SUPERIORITY|||||||1||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group||||1.000
91740396|NCT04417257|183372926|SUPERIORITY|||||||0.068||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants with health status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.||||0.0680
91740397|NCT04417257|183372926|SUPERIORITY|||||||0.0534||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants with health status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.||||0.0534
91740398|NCT04417257|183372927|SUPERIORITY|||||||0.7923||||||Two-sided test|Fisher Exact|||Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group||||0.7923
91740399|NCT04417257|183372928|SUPERIORITY|||||||0.8886||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group.||||0.8886
91740400|NCT04417257|183372928|SUPERIORITY|||||||0.2735||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.||||0.2735
91740401|NCT04417257|183372928|SUPERIORITY|||||||0.3604||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.||||0.3604
91740402|NCT04417257|183372929|SUPERIORITY|||||||1||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group.||||1.000
91499721|NCT05185089|182869267|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.08|STANDARD_ERROR_OF_MEAN|1.108||0.449|TWO_SIDED|95.0|0.88|1.34|||ANCOVA|||||1.34|0.88|0.449
91740403|NCT04417257|183372929|SUPERIORITY|||||||0.0253||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.||||0.0253
91740404|NCT04417257|183372929|SUPERIORITY|||||||0.2729||||||two-sided test|Fisher Exact|||Calculated based on the total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.||||0.2729
91740405|NCT04417257|183372930|SUPERIORITY|||||||0.646||||||Alpha set at 0.05|Mixed Models Analysis|||Null hypothesis of no difference||||0.6460
91740406|NCT04417257|183372931|SUPERIORITY|||||||0.8722|||||||Log Rank|||If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Overall ITT population.||||0.8722
91740407|NCT04417257|183372931|SUPERIORITY|||||||0.539|||||||Log Rank|||If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Participants with Health Status 3 + 4 at baseline.||||0.5390
91740408|NCT04417257|183372931|SUPERIORITY|||||||0.2319|||||||Log Rank|||If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Participants with Health Status 5 at baseline.||||0.2319
91740409|NCT04417257|183372932|SUPERIORITY|||||||0.9358|||||||Log Rank|||If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Overall ITT population.||||0.9358
91740410|NCT04417257|183372932|SUPERIORITY|||||||0.63|||||||Log Rank|||If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Participants with Health Status 3 + 4 at baseline.||||0.6300
91740411|NCT04417257|183372932|SUPERIORITY|||||||0.655|||||||Log Rank|||If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Participants with Health Status 5 at baseline.||||0.6550
91740412|NCT04417257|183372933|SUPERIORITY|||||||0.9101||||||Two-sided test|Log Rank|||If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Overall ITT population.||||0.9101
91740413|NCT04417257|183372936|SUPERIORITY|||||||0.2706||||||two-sided test|Wilcoxon (Mann-Whitney)|||Overall ITT population. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.||||0.2706
91499722|NCT05185089|182869267|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.04|STANDARD_ERROR_OF_MEAN|1.125||0.732|TWO_SIDED|95.0|0.82|1.32|||ANCOVA|||||1.32|0.82|0.732
91499723|NCT05185089|182869268|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.14|STANDARD_ERROR_OF_MEAN|1.161||0.4|TWO_SIDED|95.0|0.84|1.54|||ANCOVA|||||1.54|0.84|0.400
91740414|NCT04417257|183372936|SUPERIORITY|||||||0.0974||||||two-sided test|Wilcoxon (Mann-Whitney)|||Participants with Health Status 3 + 4 at baseline. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.||||0.0974
91740415|NCT04417257|183372936|SUPERIORITY|||||||0.5549||||||two-sided test|Wilcoxon (Mann-Whitney)|||Participants with Health Status 5 at baseline. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.||||0.5549
91740416|NCT04417257|183372937|SUPERIORITY|||||||0.4787||||||Two-sided test|Wilcoxon (Mann-Whitney)|||Overall ITT population. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value||||0.4787
91740417|NCT04417257|183372939|SUPERIORITY||Least Squares Mean difference|-0.02||||0.4746|TWO_SIDED|95.0|-0.07|0.03|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 14 or end of hospitalization data.||0.03|-0.07|0.4746
91740418|NCT04417257|183372939|SUPERIORITY||Leat Squares Mean difference|-0.01||||0.7445|TWO_SIDED|95.0|-0.06|0.05|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 29.||0.05|-0.06|0.7445
91740419|NCT04417257|183372939|SUPERIORITY||Least Squares Mean difference|-0.01||||0.7105|TWO_SIDED|95.0|-0.07|0.05|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 45.||0.05|-0.07|0.7105
91740420|NCT04417257|183372939|SUPERIORITY||Least Squares Mean difference|-0.01||||0.6424|TWO_SIDED|95.0|-0.07|0.04|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 60.||0.04|-0.07|0.6424
91740421|NCT04417257|183372939|SUPERIORITY||Least Square Means difference|0.05||||0.2789|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 14 or end of hospitalization data.||0.14|-0.04|0.2789
91499724|NCT05185089|182869268|SUPERIORITY||Ratio of Geometric LS Mean Ratios|0.98|STANDARD_ERROR_OF_MEAN|1.187||0.912|TWO_SIDED|95.0|0.69|1.4|||ANCOVA|||||1.40|0.69|0.912
91499725|NCT05185089|182869269|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.09|STANDARD_ERROR_OF_MEAN|1.084||0.287|TWO_SIDED|95.0|0.93|1.29|||ANCOVA|||||1.29|0.93|0.287
91499726|NCT05185089|182869269|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.08|STANDARD_ERROR_OF_MEAN|1.092||0.42|TWO_SIDED|95.0|0.9|1.29|||ANCOVA|||||1.29|0.90|0.420
91499727|NCT05185089|182869270|SUPERIORITY||Ratio of Geometric LS Mean Ratios|1.01|STANDARD_ERROR_OF_MEAN|1.022||0.765|TWO_SIDED|95.0|0.96|1.05|||ANCOVA|||||1.05|0.96|0.765
91499728|NCT05185089|182869270|SUPERIORITY||Ratio of Geometric LS Mean Ratios|0.9|STANDARD_ERROR_OF_MEAN|1.033||0.004|TWO_SIDED|95.0|0.85|0.97|||ANCOVA|||||0.97|0.85|0.004
91499729|NCT00770289|182869273|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.899|||<|0.0001|TWO_SIDED|95.0|0.886|0.911||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.911|0.886|<0.0001
91740422|NCT04417257|183372939|SUPERIORITY||Least Square Means difference|0.05||||0.2884|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 29||0.14|-0.04|0.2884
91740423|NCT04417257|183372939|SUPERIORITY||Least Square Means difference|0.06||||0.2058|TWO_SIDED|95.0|-0.03|0.15|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 45||0.15|-0.03|0.2058
91740424|NCT04417257|183372939|SUPERIORITY||Least Square Means difference|0.03||||0.516|TWO_SIDED|95.0|-0.06|0.12|||Mixed Models Analysis||A negative difference favours LAU-7b, a positive difference favours placebo.|The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 60||0.12|-0.06|0.5160
91740425|NCT00553410|183372963|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.31|TWO_SIDED|95.0|0.93|1.26|||Log Rank|||||1.26|.93|.31
91740426|NCT00553410|183372964|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.16|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|.68|.16
91740427|NCT00553410|183372965|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.25|TWO_SIDED|95.0|0.71|1.09|||Log Rank|||||1.09|.71|.25
91740428|NCT00553410|183372966|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|.81|.84
91740429|NCT01328743|183372967|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||.04
91740430|NCT01328743|183372968|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
91740431|NCT01328743|183372969|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
91740432|NCT01328743|183372970|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
91740433|NCT01328743|183372971|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
91499730|NCT00770289|182869273|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.797|||<|0.0001|TWO_SIDED|95.0|0.771|0.82||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.820|0.771|<0.0001
91740434|NCT01328743|183372972|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91740435|NCT03137771|183372999|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.66|TWO_SIDED|95.0|0.68|1.4|||Log Rank|Two-sided test|Reference level = systemic therapy. Cox proportional hazards model stratified by histology (non-squamous vs squamous) and systemic therapy (immunotherapy-based regimens vs chemotherapy- only regimens).|Based on expected 6- and 12-month PFS rates of approximately 60% and 39% for the standard arm, assuming approximately exponential distributions, at least 138 PFS events are needed to detect a hazard ratio of 0.6 (a hazard reduction of 40%) with 95% power and a one-sided significance level of 0.15. The Cox proportional hazards model is stratified by histology and systemic therapy type. The hazard ratio estimate must be ≤ 0.83 for the study to proceed to the phase III component.||1.40|0.68|0.66
91740436|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 5.||||=0.029
91740437|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 11.||||=0.027
91740438|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.602|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at end of FU.||||=0.602
91531174|NCT00826280|182939022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9328||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.9328
91740439|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.631|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 5.||||=0.631
91740440|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.339|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 11.||||=0.339
91740441|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at end of FU.||||=0.440
91740442|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 5.||||=1.000
91740443|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.465|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 11.||||=0.465
91740444|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.431|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at end of FU.||||=0.431
91740445|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.65|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 5.||||=0.650
91740446|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.98|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 11.||||=0.980
91740447|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.906|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at end of FU.||||=0.906
91740448|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.381|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 5.||||=0.381
91740449|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.886|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 11.||||=0.886
91740450|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.264|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at end of FU.||||=0.264
91740451|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.424|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 5.||||=0.424
91740452|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 11.||||=1.000
91740453|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.312|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at end of FU.||||=0.312
91499731|NCT00770289|182869273|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.765|||<|0.0001|TWO_SIDED|95.0|0.736|0.791||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.791|0.736|<0.0001
91740454|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.664|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at Cycle 5.||||=0.664
91499732|NCT02733991|182869275|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.25|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-2.25|-3.51|<0.0001
91499733|NCT02733991|182869276|SUPERIORITY||Mean Difference (Final Values)|-42.62|||<|0.0001|TWO_SIDED|95.0|-52.01|-33.19|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-33.19|-52.01|<0.0001
91499734|NCT02733991|182869277|NON_INFERIORITY|Non-inferiority margin of 40 min/day|Mean Difference (Final Values)|-38.8|||||ONE_SIDED|97.5||-0.46|||||Model based Estimated mean; difference = control arm - treatment arm|||-0.46||
91740455|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue functioning statistical analysis at Cycle 11.||||=0.170
91740456|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.318|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at end of FU.||||=0.318
91740457|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.536|TWO_SIDED||||||t-test, 2 sided|||CFB in Nausea/vomiting statistical analysis at Cycle 5.||||=0.536
91740458|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.9|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at Cycle 11.||||=0.900
91740459|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.188|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at end of FU.||||=0.188
91740460|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.37|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 5.||||=0.370
91740461|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|0.813|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 11.||||=0.813
91740462|NCT00532129|183373023|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at end of FU.||||=1.000
91740463|NCT03052608|183373024|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.191|0.413||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ethnicity and brain metastases) was significant at the 0.0081 level at the cutoff date of this report.|one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|The study was designed to test the null hypothesis H0: λ ≥1 versus the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR; Lorlatinib/Crizotinib). Evaluation of 177 PFS events was required to have at least 90% power to detect a HR of 0.611 using a one-sided stratified log-rank test at a significance level of 0.025 (one-sided), and a 2-look group-sequential design with a Lan-DeMets (O'Brien-Fleming) α-spending function to determine the efficacy boundaries.||0.413|0.191|<0.0001
91740464|NCT03052608|183373025|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.414|1.249|||||Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.249|0.414|
91740465|NCT03052608|183373026|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.144|0.307|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.307|0.144|<0.0001
91740466|NCT03052608|183373027|SUPERIORITY||Odds Ratio (OR)|2.254||||0.0005|TWO_SIDED|95.0|1.353|3.891|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||3.891|1.353|0.0005
91740467|NCT03052608|183373028|SUPERIORITY||Odds Ratio (OR)|2.499||||0.0002|TWO_SIDED|95.0|1.484|4.594|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||4.594|1.484|0.0002
91740468|NCT03052608|183373029|SUPERIORITY||Odds Ratio (OR)|8.407|||<|0.0001|TWO_SIDED|95.0|2.586|27.233|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||27.233|2.586|<0.0001
91740469|NCT03052608|183373030|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.026|0.17|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.170|0.026|<0.0001
91740470|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|4.65||||0.0096|TWO_SIDED|95.0|1.14|8.16|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||8.16|1.14|0.0096
91740471|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|2.02||||0.1897|TWO_SIDED|95.0|-1.01|5.05|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.05|-1.01|0.1897
91499735|NCT02733991|182869277|SUPERIORITY||Mean Difference (Final Values)|38.8||||0.0474|TWO_SIDED|95.0|0.46|77.11|||Mixed Models Analysis||Model based Estimated mean; Difference = Treatment arm - Control arm|||77.11|0.46|0.0474
91499736|NCT02956486|182869285|SUPERIORITY||Least Square (LS) Mean Difference|-0.17||||0.385|TWO_SIDED|95.0|-0.57|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (mild cognitive impairment \[MCI\]/Prodromal, mild alzheimer's disease \[AD\]), concurrent AD medication use, region, apolipoprotein E (ApoE4) status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.57|0.385
91499737|NCT02956486|182869287|SUPERIORITY||LS Mean Difference|-0.02||||0.345|TWO_SIDED|95.0|-0.06|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.06|0.345
91499738|NCT02956486|182869288|SUPERIORITY||LS Mean Difference|-12.83|||<|0.001|TWO_SIDED|95.0|-18.79|-6.88|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||-6.88|-18.79|<.001
91740472|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|2.09||||0.2999|TWO_SIDED|95.0|-1.87|6.04|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||6.04|-1.87|0.2999
91740473|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|2.58||||0.0553|TWO_SIDED|95.0|-0.06|5.22|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.22|-0.06|0.0553
91740474|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-3.18||||0.0588|TWO_SIDED|95.0|-6.47|0.12|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.12|-6.47|0.0588
91740475|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|2.27||||0.2118|TWO_SIDED|95.0|-1.3|5.85|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.85|-1.30|0.2118
91740476|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-5.67||||0.0032|TWO_SIDED|95.0|-9.42|-1.92|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.92|-9.42|0.0032
91740477|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-7.86|||<|0.0001|TWO_SIDED|95.0|-9.86|-5.86|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-5.86|-9.86|<0.0001
91740478|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|1.16||||0.531|TWO_SIDED|95.0|-2.49|4.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.82|-2.49|0.5310
91740479|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|1.72||||0.3602|TWO_SIDED|95.0|-1.98|5.43|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.43|-1.98|0.3602
91740480|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-7.95|||<|0.0001|TWO_SIDED|95.0|-11.25|-4.64|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-4.64|-11.25|<0.0001
91740481|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-9.21|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.62|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-6.62|-11.80|<0.0001
91740482|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-4.93||||0.0198|TWO_SIDED|95.0|-9.07|-0.79|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Constipation. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-0.79|-9.07|0.0198
91740483|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-12.03|||<|0.0001|TWO_SIDED|95.0|-15.49|-8.58|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Diarrhea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-8.58|-15.49|<0.0001
91740484|NCT03052608|183373045|SUPERIORITY||Mean Difference (Net)|-1.04||||0.5947|TWO_SIDED|95.0|-4.9|2.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Financial Difficulties. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||2.82|-4.90|0.5947
91740485|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|0.55||||0.7254|TWO_SIDED|95.0|-2.51|3.6|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.60|-2.51|0.7254
91760108|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|95.0|-1.94|-0.91||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.91|-1.94|
91740486|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|-4.55||||0.0115|TWO_SIDED|95.0|-8.06|-1.03|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.03|-8.06|0.0115
91740487|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|0.12||||0.7824|TWO_SIDED|95.0|-0.75|0.99|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.99|-0.75|0.7824
91740488|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|1.16||||0.2988|TWO_SIDED|95.0|-1.04|3.36|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.36|-1.04|0.2988
91740489|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|-1.51||||0.1916|TWO_SIDED|95.0|-3.79|0.76|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.76|-3.79|0.1916
91740490|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|5.37||||0.0279|TWO_SIDED|95.0|0.59|10.15|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||10.15|0.59|0.0279
91740491|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9162|TWO_SIDED|95.0|-3.89|3.49|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.49|-3.89|0.9162
91740492|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|-0.53||||0.6698|TWO_SIDED|95.0|-2.96|1.9|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||1.90|-2.96|0.6698
91740493|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|0.45||||0.8035|TWO_SIDED|95.0|-3.13|4.04|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.04|-3.13|0.8035
91740494|NCT03052608|183373046|SUPERIORITY||Mean Difference (Net)|3.36||||0.1143|TWO_SIDED|95.0|-0.82|7.55|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||7.55|-0.82|0.1143
91740495|NCT03052608|183373049|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7293|TWO_SIDED|95.0|0.822|1.444|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.444|0.822|0.7293
91740496|NCT05554146|183373056|SUPERIORITY||Beta|-2.6185||||0.0303|TWO_SIDED|95.0|-4.98|-0.25||A mixed effects model was completed with Arm 2 as the reference.|Mixed Models Analysis|There were no adjustments for any covariates.|Arm 2 was the comparison arm.|The study team hypothesized that participants randomized to coupons for high THC products would have greater reduction in self-reported pain severity than high CBD, equal parts THC and CBD, or placebo.||-0.25|-4.98|0.0303
91740497|NCT05554146|183373056|SUPERIORITY||Beta|-0.8424||||0.4851|TWO_SIDED|||||A mixed effects model was completed with Arm 2 as the reference.|Mixed Models Analysis|There were no adjustments for any covariates.|Arm 2 was the comparison arm.|The study team hypothesized that participants randomized to coupons for high THC products would have greater reduction in self-reported pain severity than high CBD, equal parts THC and CBD, or placebo.||||0.4851
91740498|NCT05554146|183373056|SUPERIORITY||Beta|-0.6038||||0.6165|TWO_SIDED|95.0||||A mixed effects model was completed with Arm 2 as the reference.|Mixed Models Analysis|There were no adjustments for any covariates.|Arm 2 was the comparison arm.|The study team hypothesized that participants randomized to coupons for high THC products would have greater reduction in self-reported pain severity than high CBD, equal parts THC and CBD, or placebo.||||0.6165
91499739|NCT02956486|182869289|SUPERIORITY||LS Mean Difference|-0.23||||0.316|TWO_SIDED|95.0|-0.67|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.67|0.316
91531175|NCT00826280|182939023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0011
91740499|NCT05554146|183373057|SUPERIORITY|An ANOVA test with mean change in NPX values was completed.|F value (F-test)|0.63||||0.6|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that anti-inflammatory cytokines (IL-4 and IL-10) would have greater increase in participants randomized to coupons for high CBD products than the other arms.||||0.6
91740500|NCT05554146|183373058|SUPERIORITY|An ANOVA test with mean change in NPX values was completed.|F value (F-test)|0.83||||0.49|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that anti-inflammatory cytokines (IL-4 and IL-10) would have greater increase in participants randomized to coupons for high CBD products than the other arms.||||0.49
91740501|NCT05554146|183373059|SUPERIORITY|An ANOVA test with mean change in NPX values was completed.|F value (F-test)|0.53||||0.66|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that pro-inflammatory cytokines (TNFa and IL-6) would have greater reduction in participants randomized to coupons for high CBD products than the other arms.||||0.66
91740502|NCT05554146|183373060|SUPERIORITY|An ANOVA test with mean change in NPX values was completed.|F value (F-test)|0.21||||0.88|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that pro-inflammatory cytokines (TNFa and IL-6) would have greater reduction in participants randomized to coupons for high CBD products than the other arms.||||0.88
91740503|NCT05554146|183373061|SUPERIORITY|An ANOVA test with the mean change in adherence score was completed.|F value (F-test)|1.11||||0.39|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that participants randomized to coupons for high THC products would have poorer Antiretroviral (ARV) medication adherence than those randomized to coupons for high CBD, equal parts THC and CBD, or placebo.||||0.39
91740504|NCT05554146|183373062|SUPERIORITY|An ANOVA test with mean change in HIV viral load was completed.|F value (F-test)|1.25||||0.31|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that participants randomized to coupons for high THC products would have less suppressed HIV viral load than those randomized to coupons for high CBD, equal parts THC and CBD or placebo.||||0.31
91740505|NCT05554146|183373063|SUPERIORITY|An ANOVA test with the mean change in depression score was completed.|F value (F-test)|2.04||||0.13|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that participants randomized to coupons for high THC products would have greater depression than those randomized to coupons for high CBD, equal parts THC and CBD, or placebo.||||0.13
91740506|NCT05554146|183373064|SUPERIORITY|An ANOVA test with the mean change in anxiety score was completed.|F value (F-test)|1.58||||0.22|TWO_SIDED||||||ANOVA|Three degrees of freedom (3 DoF)||The study team hypothesized that participants randomized to coupons for high THC products would have greater anxiety than those randomized to coupons for high CBD, equal parts THC and CBD, or placebo.||||0.22
91740507|NCT01139411|183373065|SUPERIORITY_OR_OTHER|||||||0.06||||||Threshold for significance: 0.05|ANCOVA|||"Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate."||||0.06
91740508|NCT01139411|183373066|SUPERIORITY_OR_OTHER|||||||0.58||||||Threshold for significance: 0.05|ANCOVA|||The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.||||0.58
91499740|NCT02956486|182869290|SUPERIORITY||LS Mean Difference|-0.03||||0.254|TWO_SIDED|95.0|-0.07|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.07|0.254
91499741|NCT02956486|182869291|SUPERIORITY||Difference of Mean Slope|-0.008||||0.9088|TWO_SIDED|95.0|-0.145|0.129|||Linear mixed effects model|||Based on the linear mixed effects model, which included assessment time and treatment group by assessment time interaction as covariate with random intercept and slope.||0.129|-0.145|0.9088
91499742|NCT02956486|182869292|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6155|TWO_SIDED|95.0|0.77|1.16|||Regression, Cox|||Based on a Cox regression model which included treatment group, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.16|0.77|0.6155
91499743|NCT02956486|182869293|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.1281|TWO_SIDED|95.0|0.96|1.35|||Regression, Cox|||Based on a Cox regression model which included treatment group, concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.35|0.96|0.1281
91499744|NCT02956486|182869294|SUPERIORITY||LS Mean Difference|-0.43||||0.525|TWO_SIDED|95.0|-1.75|0.9|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.90|-1.75|0.525
91499745|NCT02956486|182869295|SUPERIORITY||LS Mean Difference|-0.01||||0.977|TWO_SIDED|95.0|-0.64|0.62|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.62|-0.64|0.977
91499746|NCT02956486|182869296|SUPERIORITY||LS Mean Difference|0.11||||0.854|TWO_SIDED|95.0|-1.09|1.32|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.32|-1.09|0.854
91499747|NCT02956486|182869297|SUPERIORITY||LS Mean Difference|-0.27||||0.314|TWO_SIDED|95.0|-0.79|0.26|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.26|-0.79|0.314
91531176|NCT00826280|182939023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0034||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0034
91740509|NCT01139411|183373067|SUPERIORITY_OR_OTHER|||||||0.19||||||Threshold for significance: 0.05|ANCOVA|||||||0.19
91740510|NCT01139411|183373068|SUPERIORITY_OR_OTHER|||||||0.72||||||Threshold for significance: 0.05|ANCOVA|||||||0.72
91740511|NCT01139411|183373069|SUPERIORITY_OR_OTHER|||||||0.41|||||||ANCOVA|||||||0.41
91740512|NCT01139411|183373070|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: 0.05|ANCOVA|||||||0.01
91740513|NCT01139411|183373071|SUPERIORITY_OR_OTHER|||||||0.61||||||Threshold for significance: 0.05|ANCOVA|||||||0.61
91740514|NCT01484496|183373090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0006|TWO_SIDED|95.0|1.25|2.25|||Regression, Logistic|||||2.25|1.25|0.0006
91740515|NCT01484496|183373091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.0004|TWO_SIDED|95.0|0.35|0.74|||Cox proportional hazards model|||||0.74|0.35|0.0004
91740516|NCT01484496|183373092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0732|TWO_SIDED|95.0|0.95|2.84|||Regression, Logistic|||||2.84|0.95|0.0732
91740517|NCT00589797|183373103|NON_INFERIORITY|The trial was designed as a non-inferiority trial with a margin (delta) of 15%. Additional analyses using a delta of 10% as requested by FDA were also conducted.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 1 sided|||||||<0.05
91740518|NCT02141672|183373114|SUPERIORITY||Odds Ratio (OR)|2.03||||0.045|TWO_SIDED|95.0|1.01|4.05|||Regression, Logistic|||Voclosporin low dose vs. placebo||4.05|1.01|0.045
91740519|NCT02141672|183373114|SUPERIORITY||Odds Ratio (OR)|1.59||||0.204|TWO_SIDED|95.0|0.78|3.27|||Regression, Logistic|||Voclosporin high dose vs. placebo||3.27|0.78|0.204
91740520|NCT02141672|183373115|SUPERIORITY||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|1.68|6.13|||Regression, Logistic|||Voclosporin low dose vs. placebo||6.13|1.68|<0.001
91740521|NCT02141672|183373115|SUPERIORITY||Odds Ratio (OR)|2.1||||0.026|TWO_SIDED|95.0|1.09|4.02|||Regression, Logistic|||Voclosporin high dose vs. placebo||4.02|1.09|0.026
91740522|NCT02141672|183373116|SUPERIORITY||Odds Ratio (OR)|1.9||||0.066|TWO_SIDED|95.0|0.96|3.78|||Regression, Logistic|||||3.78|0.96|0.066
91740523|NCT02141672|183373116|SUPERIORITY||Odds Ratio (OR)|1.64||||0.162|TWO_SIDED|95.0|0.82|3.28|||Regression, Logistic|||||3.28|0.82|0.162
91740524|NCT02141672|183373117|SUPERIORITY||Hazard Ratio (HR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51|||Regression, Cox|||Voclosporin low dose vs. placebo||3.51|1.45|<0.001
91740525|NCT02141672|183373117|SUPERIORITY||Hazard Ratio (HR)|2.25|||<|0.001|TWO_SIDED|95.0|1.46|3.47|||Regression, Cox|||Voclosporin high dose vs. placebo||3.47|1.46|<0.001
91499748|NCT02956486|182869298|SUPERIORITY||LS Mean Difference|0.07||||0.895|TWO_SIDED|95.0|-0.93|1.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.07|-0.93|0.895
91740526|NCT02141672|183373118|SUPERIORITY||Hazard Ratio (HR)|2.89|||<|0.001|TWO_SIDED|95.0|1.58|5.29|||Regression, Cox|||||5.29|1.58|<0.001
91740527|NCT02141672|183373118|SUPERIORITY||Hazard Ratio (HR)|1.48|||<|0.248|TWO_SIDED|95.0|0.77|2.86|||Regression, Cox|||Voclosporin high dose vs. placebo||2.86|0.77|<0.248
91740528|NCT02141672|183373120|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.005|TWO_SIDED|95.0|1.16|2.27|||Regression, Cox|||||2.27|1.16|0.005
91740529|NCT02141672|183373120|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.002|TWO_SIDED|95.0|1.25|2.43|||Regression, Cox|||Voclosporin high dose vs. placebo||2.43|1.25|0.002
91740530|NCT02141672|183373122|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.45|2.15|||Regression, Cox|||Voclosporin low dose vs. placebo||2.15|0.45|0.980
91740531|NCT02141672|183373122|SUPERIORITY||Hazard Ratio (HR)|1.98||||0.118|TWO_SIDED|95.0|0.95|4.16|||Regression, Cox|||Voclosporin high dose vs. placebo||4.16|0.95|0.118
91740532|NCT02141672|183373124|SUPERIORITY||Odds Ratio (OR)|2.33||||0.007|TWO_SIDED|95.0|1.26|4.33|||Regression, Logistic|||week 24||4.33|1.26|0.007
91740533|NCT02141672|183373124|SUPERIORITY||Odds Ratio (OR)|2.03||||0.024|TWO_SIDED|95.0|1.1|3.76|||Regression, Logistic|||week 24||3.76|1.1|0.024
91740534|NCT02141672|183373124|SUPERIORITY||Odds Ratio (OR)|2.34||||0.007|TWO_SIDED|95.0|1.27|4.33|||Regression, Logistic|||week 48||4.33|1.27|0.007
91740535|NCT02141672|183373124|SUPERIORITY||Odds Ratio (OR)|2.68||||0.002|TWO_SIDED|95.0|1.43|5.02|||Regression, Logistic|||week 48||5.02|1.43|0.002
91740536|NCT02141672|183373125|SUPERIORITY||Hazard Ratio (HR)|2.03|||<|0.001|TWO_SIDED|95.0|1.36|3.03|||Regression, Cox|||Voclosporin low dose vs. placebo||3.03|1.36|<0.001
91740537|NCT02141672|183373125|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.004|TWO_SIDED|95.0|1.22|2.69|||Regression, Cox|||Voclosporin high dose vs. placebo||2.69|1.22|0.004
91740538|NCT02141672|183373127|SUPERIORITY||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.45|3.36|||Regression, Cox|||Voclosporin low dose vs. placebo||3.36|1.45|<0.001
91740539|NCT02141672|183373127|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.004|TWO_SIDED|95.0|1.23|2.84|||Regression, Cox|||Voclosporin high dose vs. placebo||2.84|1.23|0.004
91740540|NCT02688192|183373133|SUPERIORITY|||||||0.39|||||||ANOVA|df = 33||Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||0.39
91740541|NCT02688192|183373133|SUPERIORITY|||||||0.49|||||||ANOVA|df = 33||Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.49
91740542|NCT02688192|183373133|SUPERIORITY|||||||0.83|||||||ANOVA|df = 33||Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.83
91499749|NCT02956486|182869299|SUPERIORITY||LS Mean Difference|0.04||||0.542|TWO_SIDED|95.0|-0.09|0.17|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.17|-0.09|0.542
91499750|NCT02956486|182869300|SUPERIORITY||LS Mean Difference|-0.01||||0.38|TWO_SIDED|95.0|-0.02|0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.01|-0.02|0.380
91499751|NCT02956486|182869301|SUPERIORITY||LS Mean Difference|-0.4||||0.063|TWO_SIDED|95.0|-0.82|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.02|-0.82|0.063
91499752|NCT02956486|182869302|SUPERIORITY||LS Mean Difference|-0.56||||0.045|TWO_SIDED|95.0|-1.11|-0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.01|-1.11|0.045
91499753|NCT02956486|182869303|SUPERIORITY||LS Mean Difference|-0.04||||0.799|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.24|-0.32|0.799
91499754|NCT02956486|182869304|SUPERIORITY||LS Mean Difference|-0.32||||0.012|TWO_SIDED|95.0|-0.56|-0.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.07|-0.56|0.012
91499755|NCT01867021|182869366|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.85|||||TWO_SIDED|95.0|1.66|2.06|||ANCOVA|Not applicable(NA)||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 22||2.06|1.66|
91499756|NCT01867021|182869366|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.38|1.64|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 22||1.64|1.38|
91499757|NCT01867021|182869366|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.93|1.08|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 22||1.08|0.93|
91740543|NCT02688192|183373134|SUPERIORITY|||||||0.98|||||||ANOVA|df = 33||Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.98
91499758|NCT01867021|182869367|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|9.0|||||TWO_SIDED|95.0|5.6|11.5|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 22||11.5|5.6|
91499759|NCT01867021|182869367|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H3N2 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|13.0|||||TWO_SIDED|95.0|10.1|16.1|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 22||16.1|10.1|
91499760|NCT01867021|182869367|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain B considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|-1.0|||||TWO_SIDED|95.0|-5.0|2.3|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 22||2.3|-5|
91499761|NCT01129960|182869376|SUPERIORITY_OR_OTHER|||||||0.3726|||||||Dunnett's test (analysis of covariance)|||||||0.3726
91499762|NCT01129960|182869376|SUPERIORITY_OR_OTHER|||||||0.8034|||||||Dunnett's test (analysis of covariance)|||||||0.8034
91499763|NCT01129960|182869376|SUPERIORITY_OR_OTHER|||||||0.1391|||||||Dunnett's test (analysis of covariance)|||||||0.1391
91499764|NCT00071513|182869389|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Mean changes in Short Moods and Feelings measure of depression was the unit of analysis.||||<0.05
91531177|NCT00826280|182939023|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91531178|NCT00826280|182939023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5902||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5902
91740544|NCT02688192|183373134|SUPERIORITY|||||||0.85|||||||ANOVA|df = 29||Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.85
91740545|NCT02688192|183373135|SUPERIORITY|||||||0.29|||||||ANOVA|df = 29||||||.29
91740546|NCT02688192|183373136|SUPERIORITY|||||||0.019|||||||ANOVA|df = 32||Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data||||.019
91740547|NCT02688192|183373136|SUPERIORITY|||||||0.34|||||||ANOVA|df = 32||Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.34
91740548|NCT01773967|183373138|SUPERIORITY|||||||0.83|||||||Mantel Haenszel|||||||0.83
91740549|NCT01773967|183373140|SUPERIORITY|||||||0.26|||||||Van Elteren's modification Mann-Whitney|||||||0.26
91740550|NCT01299389|183373225|SUPERIORITY_OR_OTHER||Least squares (LS) means difference|-9.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-14.0|-5.4|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.||-5.4|-14.0|<0.0001
91740551|NCT01299389|183373228|SUPERIORITY_OR_OTHER||LS Mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.1|-1.4|||ANCOVA|||Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.4|-4.1|<0.0001
91740552|NCT01299389|183373228|SUPERIORITY_OR_OTHER||LS Mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.61||0.0012|TWO_SIDED|95.0|-3.2|-0.8|||ANCOVA|||Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.8|-3.2|0.0012
91740553|NCT01299389|183373228|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-3.4|-1.1|||ANCOVA|||Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.1|-3.4|<0.0001
91499765|NCT00071513|182869389|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||A secondary hypothesis of the study was that attachment to school and/or perceptions of school supportiveness would mediate the effect of the HSTS intervention on depressive symptoms.||||<0.01
91740554|NCT01299389|183373228|SUPERIORITY_OR_OTHER||LS Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0023|TWO_SIDED|95.0|-2.3|-0.5|||ANCOVA|||Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.5|-2.3|0.0023
91740555|NCT01299389|183373228|SUPERIORITY_OR_OTHER||LS Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0025|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|||Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.4|-1.9|0.0025
91740556|NCT01299389|183373229|SUPERIORITY_OR_OTHER||LS Mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.59||0.0003|TWO_SIDED|95.0|-3.3|-1.0|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.0|-3.3|0.0003
91740557|NCT01299389|183373230|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.1|-1.5|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.5|-4.1|<0.0001
91740558|NCT01299389|183373231|SUPERIORITY_OR_OTHER||LS Mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-6.9|-2.3|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-2.3|-6.9|<0.0001
91499766|NCT03171415|182869456|SUPERIORITY||||||>|0.05|TWO_SIDED|5.0|||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||>0.05
91499767|NCT03171415|182869456|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups, at day 28 and Day 56||||<0.05
91740559|NCT02185534|183373258|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|104.43|||||TWO_SIDED|90.0|92.27|118.19|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||118.19|92.27|
91740560|NCT02185534|183373258|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|Geometric mean ratio|97.19|||||TWO_SIDED|90.0|81.12|116.45|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25||116.45|81.12|
91740561|NCT02185534|183373259|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|108.06|||||TWO_SIDED|90.0|95.46|122.33|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||122.33|95.46|
91760109|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-1.8|-0.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.76|-1.80|
91760110|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||||TWO_SIDED|95.0|-1.06|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.06|
91740562|NCT02185534|183373259|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|105.79|||||TWO_SIDED|90.0|95.22|117.53|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||117.53|95.22|
91740563|NCT02185534|183373260|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|93.94|||||TWO_SIDED|90.0|87.12|101.29|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||101.29|87.12|
91740564|NCT02185534|183373260|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|92.03|||||TWO_SIDED|90.0|84.91|99.75|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||99.75|84.91|
91740565|NCT00362882|183373288|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
91740566|NCT00361972|183373308|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91740567|NCT00361972|183373309|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91740568|NCT00149799|183373326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.73||||0.048|TWO_SIDED|95.0|1.01|8.59|||Regression, Cox|p-value is based on the likelihood ratio Chi-Square statistic.||Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.||8.59|1.01|0.048
91740569|NCT00149799|183373328|SUPERIORITY||Slope difference|-0.07006|STANDARD_ERROR_OF_MEAN|0.04163||0.093|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=556||"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group \[to be tested\]."||||0.0930
91740570|NCT00149799|183373329|SUPERIORITY||Slope difference|0.001176|STANDARD_ERROR_OF_MEAN|0.03991||0.9766|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=43||"We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.9766
91759512|NCT02391363|183411763|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
91759513|NCT02391363|183411764|SUPERIORITY|||||||0.92||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.92
91759514|NCT02391363|183411765|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
91499768|NCT03171415|182869456|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
91499769|NCT03171415|182869456|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
91499770|NCT03171415|182869457|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91499771|NCT03171415|182869457|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91499772|NCT03171415|182869457|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91499773|NCT03171415|182869457|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91760111|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|||||TWO_SIDED|95.0|-1.85|-0.81||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.81|-1.85|
91740571|NCT00149799|183373330|SUPERIORITY||Slope difference|0.05723|STANDARD_ERROR_OF_MEAN|0.1963||0.7724|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=36||"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.7724
91740572|NCT02737501|183373355|SUPERIORITY||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.35|0.66||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.|||0.66|0.35|<0.0001
91740573|NCT02737501|183373356|SUPERIORITY||Odds Ratio (OR)|1.74||||0.033|TWO_SIDED|95.0|1.04|2.91|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of intracranial central nervous system (iCNS) metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||2.91|1.04|0.0330
91740574|NCT02737501|183373357|SUPERIORITY||Odds Ratio (OR)|13.56|||<|0.0001|TWO_SIDED|95.0|4.7|39.11|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).|||39.11|4.70|<0.0001
91740575|NCT02737501|183373358|SUPERIORITY||Hazard Ratio (HR)|0.293|||<|0.0001|TWO_SIDED|95.0|0.17|0.51||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.|||0.51|0.17|<0.0001
91740576|NCT02737501|183373362|SUPERIORITY||Odds Ratio (OR)|0.93||||0.822|TWO_SIDED|95.0|0.47|1.82|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of iCNS metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||1.82|0.47|0.8220
91740577|NCT02737501|183373364|SUPERIORITY||Least Square Mean Difference|5.79||||0.0295|TWO_SIDED|95.0|0.58|11.0||p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.|Mixed Models Analysis|A mixed effect model is used with an unstructured covariance matrix.||||11.00|0.58|0.0295
91740578|NCT02012218|183373365|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values were calculated according to testing a null hypothesis of zero mean change.|Mixed Models Analysis|This analysis was conducted using a mixed model repeated measures analysis on observed case data.||The null hypothesis of zero in mean change from baseline in MADRS total score at Week 6 was tested for each treatment group at significance level of 0.05 (2-sided).||||<0.0001
91740579|NCT01482715|183373414|OTHER||RP2D|600.0|||||TWO_SIDED||||||||||A MTD was not established based on observation of DLTs in Cycle 1 of treatment. The 600 mg BID dose was considered to be the maximum dose with an acceptable toxicity profile that could be continuously administered to patients and was selected as the recommended Phase 2 dose (RP2D).|||
91740580|NCT00996658|183373457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.0001||95.0|-0.83|-0.31|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.31|-0.83|< 0.0001
91740581|NCT00996658|183373458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001||95.0|-0.61|-0.21|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.21|-0.61|< 0.0001
91740582|NCT00996658|183373459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.79|-0.28|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.28|-0.79|< 0.0001
91740583|NCT00996658|183373460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.8|-0.29|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.29|-0.80|< 0.0001
91740584|NCT00996658|183373461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.939||||0.0033|TWO_SIDED|95.0|1.432|6.032|||Regression, Logistic|||Linagliptin vs Placebo||6.032|1.432|0.0033
91740585|NCT00996658|183373462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.902||||0.0074|TWO_SIDED|95.0|1.44|10.572|||Regression, Logistic|||Linagliptin vs Placebo||10.572|1.440|0.0074
91740586|NCT00996658|183373463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.059||||0.0071|TWO_SIDED|95.0|1.216|3.485|||Regression, Logistic|||Linagliptin vs. Placebo||3.485|1.216|0.0071
91740587|NCT00996658|183373464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.028||95.0|-19.6|-1.1|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.1|-19.6|0.0280
91740588|NCT00996658|183373465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7||||0.0006||95.0|-24.5|-6.8|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-6.8|-24.5|0.0006
91740589|NCT00996658|183373466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.021||95.0|-20.2|-1.7|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.7|-20.2|0.0210
91740590|NCT00996658|183373467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2137||95.0|-16.0|3.6|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||3.6|-16.0|0.2137
91740591|NCT04566731|183373492|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91740592|NCT04267926|183373493|OTHER|||||||0.9489|TWO_SIDED||||||Mixed Models Analysis||||In our work there are several hypotheses for the group comparison for the change. Therefore multiple estimate values that are not suitable for the questions above.|||0.9489
91740593|NCT00661830|183373503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.281|||||TWO_SIDED|95.0|0.811|2.023|||Regression, Cox|||||2.023|0.811|
91740594|NCT00661830|183373504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.747|1.927|||Regression, Cox|||||1.927|0.747|
91740595|NCT02621476|183373640|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91740596|NCT03198767|183373641|SUPERIORITY||Ratio of number of events|0.71||||0.202|TWO_SIDED|80.0|0.5|1.0|||Mixed Models Analysis|||Day 3||1.00|0.50|0.202
91740597|NCT03198767|183373641|SUPERIORITY||Ratio of number of events|0.21|||<|0.001|TWO_SIDED|80.0|0.14|0.32|||Mixed Models Analysis|||Day 3||0.32|0.14|<0.001
91740598|NCT03198767|183373641|SUPERIORITY||Ratio of number of events|0.3|||<|0.001|TWO_SIDED|80.0|0.19|0.46|||Mixed Models Analysis|||Day 3||0.46|0.19|<0.001
91740599|NCT03198767|183373641|SUPERIORITY||Ratio of number of events|0.79||||0.275|TWO_SIDED|80.0|0.6|1.04|||Mixed Models Analysis|||Day 3||1.04|0.60|0.275
91740600|NCT03198767|183373641|SUPERIORITY||Ratio of number of events|0.78||||0.234|TWO_SIDED|80.0|0.59|1.02|||Mixed Models Analysis|||Day 3||1.02|0.59|0.234
91740601|NCT03198767|183373641|SUPERIORITY||Ratio of number of events|0.98||||0.921|TWO_SIDED|80.0|0.73|1.3|||Mixed Models Analysis|||Day 3||1.30|0.73|0.921
91740602|NCT03198767|183373642|SUPERIORITY||Ratio of number of events|0.68||||0.04|TWO_SIDED|80.0|0.54|0.86|||Mixed Models Analysis|||||0.86|0.54|0.040
91740603|NCT03198767|183373642|SUPERIORITY||Ratio of number of events|0.37|||<|0.001|TWO_SIDED|80.0|0.28|0.49|||Mixed Models Analysis|||||0.49|0.28|<0.001
91740604|NCT03198767|183373642|SUPERIORITY||Ratio of number of events|0.54||||0.008|TWO_SIDED|80.0|0.41|0.72|||Mixed Models Analysis|||||0.72|0.41|0.008
91740605|NCT03198767|183373642|SUPERIORITY||Ratio of number of events|0.79||||0.141|TWO_SIDED|80.0|0.65|0.97|||Mixed Models Analysis|||||0.97|0.65|0.141
91740606|NCT03198767|183373642|SUPERIORITY||Ratio of number of events|0.9||||0.51|TWO_SIDED|80.0|0.74|1.1|||Mixed Models Analysis|||||1.10|0.74|0.510
91740607|NCT03198767|183373642|SUPERIORITY||Ratio of number of events|1.14||||0.401|TWO_SIDED|80.0|0.93|1.41|||Mixed Models Analysis|||||1.41|0.93|0.401
91740608|NCT03198767|183373643|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.426|TWO_SIDED|80.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.426
91740609|NCT03198767|183373643|SUPERIORITY||Median Difference (Final Values)|-1.06||||0.001|TWO_SIDED|80.0|-1.46|-0.67|||Mixed Models Analysis|||||-0.67|-1.46|0.001
91740610|NCT03198767|183373643|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.009|TWO_SIDED|80.0|-1.25|-0.45|||Mixed Models Analysis|||||-0.45|-1.25|0.009
91740611|NCT03198767|183373643|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.135|TWO_SIDED|80.0|-0.68|-0.05|||Mixed Models Analysis|||||-0.05|-0.68|0.135
91740612|NCT03198767|183373643|SUPERIORITY||Median Difference (Final Values)|-0.19||||0.436|TWO_SIDED|80.0|-0.5|0.12|||Mixed Models Analysis|||||0.12|-0.50|0.436
91740613|NCT03198767|183373643|SUPERIORITY||Median Difference (Final Values)|0.18||||0.452|TWO_SIDED|80.0|-0.13|0.49|||Mixed Models Analysis|||||0.49|-0.13|0.452
91740614|NCT02820844|183373652|OTHER||Mean Difference (Net)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.14|-1.18||Analysis was performed using mixed-model for repeated measures (MMRM) with treatment, site, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||-1.18|-3.14|<0.001
91740615|NCT02820844|183373653|OTHER||Mean Difference (Net)|29.69|||<|0.001|TWO_SIDED|95.0|18.47|40.91||Analysis performed using MMRM, with treatment, site, visit, Baseline urinary urgency incontinence (UUI) episodes over 3 day diary (\<=9 or \>=10), treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||40.91|18.47|<0.001
91740616|NCT02820844|183373708|OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10).|Log Rank||Hazard ratio and 95% Confidence Interval (CI) are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.60|0.34|<0.001
91740617|NCT02820844|183373709|OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.66||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10)|Log Rank||Hazard ratio and 95% CI are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.66|0.38|<0.001
91740618|NCT01135459|183373835|OTHER||Odds Ratio (OR)|0.7649||||0.3989|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Analysis was performed using a logistic regression model with treatment and stratification factors as main factors.||1.4|0.4|0.3989
91760112|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59|||||TWO_SIDED|95.0|0.19|0.98||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.98|0.19|
91760113|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.22|0.56||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.22|
91740619|NCT01803880|183373846|NON_INFERIORITY|"Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference \<10.~Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0."|One-sided 97.5% confidence interval (CI)|-7.42|STANDARD_ERROR_OF_MEAN|5.137|>|0.05|ONE_SIDED|97.5|-19.29|||All unscheduled visits were to be included and nominal visits were to be applied using analysis visit windows. Both the assigned analysis visits and the site reported nominal visits were provided in the subject data listings.|ANCOVA|Due to early termination, all inferential analysis was interpreted as descriptive and carried out in an exploratory manner.||An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study-Control) was to be used for determining non-inferiority/superiority of the study device.|||-19.29|>0.05
91740620|NCT03703232|183373860|SUPERIORITY|||||||0.092|||||||Wilcoxon signed-rank test|||||||0.092
91740621|NCT03703232|183373861|SUPERIORITY|||||||0.76|||||||Wilcoxon signed-rank test|||||||0.760
91740622|NCT03703232|183373862|SUPERIORITY|||||||0.007|||||||Wilcoxon signed-rank test|||||||0.007
91740623|NCT03703232|183373863|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank test|||||||0.003
91740624|NCT03703232|183373864|SUPERIORITY|||||||0.861|||||||Wilcoxon signed-rank test|||||||0.861
91740625|NCT03703232|183373866|SUPERIORITY|||||||0.405|||||||Wilcoxon signed-rank test|||||||0.405
91740626|NCT03703232|183373867|SUPERIORITY|||||||0.798|||||||Wilcoxon signed-rank test|||||||0.798
91740627|NCT03703232|183373868|SUPERIORITY|||||||0.382|||||||Wilcoxon signed-rank test|||||||0.382
91740628|NCT03703232|183373869|SUPERIORITY|||||||0.179|||||||Wilcoxon signed-rank test|||||||0.179
91740629|NCT03703232|183373870|SUPERIORITY|||||||0.984|||||||Wilcoxon signed-rank test|||||||0.984
91740630|NCT01816776|183373871|SUPERIORITY||Risk Difference (RD)|41.0|||<|0.0001|TWO_SIDED|95.0|25.0|54.0||1-sided. p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||54|25|<0.0001
91740631|NCT01816776|183373873|SUPERIORITY||Mean Difference (Net)|-22.8|||<|0.0001|TWO_SIDED|95.0|-29.0|-16.6||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-16.6|-29.0|<0.0001
91740632|NCT01816776|183373874|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.0001|TWO_SIDED|95.0|-31.2|-18.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-18.7|-31.2|<0.0001
91740633|NCT01816776|183373875|SUPERIORITY||Mean Difference (Net)|-15.2|||<|0.0001|TWO_SIDED|95.0|-21.6|-8.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-8.7|-21.6|<0.0001
91740634|NCT01816776|183373876|SUPERIORITY||Mean Difference (Net)|2.4||||0.0244|TWO_SIDED|95.0|-0.4|5.1||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||5.1|-0.4|0.0244
91499774|NCT03171415|182869463|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91740635|NCT01816776|183373877|SUPERIORITY||Risk Difference (RD)|55.0|||<|0.0001|TWO_SIDED|95.0|40.0|68.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||68|40|<0.0001
91740636|NCT01816776|183373878|SUPERIORITY||Mean Difference (Net)|-22.7|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.5||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-16.5|-28.9|<0.0001
91740637|NCT01816776|183373879|SUPERIORITY||Mean Difference (Net)|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.5|-2.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-2.0|-5.5|<0.0001
91740638|NCT02651116|183373884|SUPERIORITY||Rate Ratio|0.7899|STANDARD_ERROR_OF_MEAN|0.0929||0.0449|TWO_SIDED|95.0|0.6273|0.9947||P-Value less than or equal to (\<=) 0.05 level was considered significantly better and P-Value lying between 0.05 less than (\<) p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per 24 hours for DXM HBr to placebo), and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9947|0.6273|0.0449
91740639|NCT02651116|183373884|SUPERIORITY|||||||0.6293||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|Negative Binomial Regression|||P-value was obtained from the negative binomial model with treatment, study site (pooled), age group, log-transformed baseline average cough count per hour (based on Baseline Run-in Period) as factors, with interaction term of treatment by age group, and logarithm of the time over which the cough count was evaluated as the offset parameter.||||0.6293
91740640|NCT02651116|183373885|SUPERIORITY||Rate Ratio|0.8048|STANDARD_ERROR_OF_MEAN|0.0912||0.0552|TWO_SIDED|95.0|0.6446|1.0049||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.0049|0.6446|0.0552
91740641|NCT02651116|183373886|SUPERIORITY||Rate Ratio|0.9551|STANDARD_ERROR_OF_MEAN|0.1491||0.7684|TWO_SIDED|95.0|0.7032|1.2971||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.2971|0.7032|0.7684
91740642|NCT02651116|183373887|SUPERIORITY||Rate Ratio|0.7014|STANDARD_ERROR_OF_MEAN|0.1086||0.022|TWO_SIDED|95.0|0.5178|0.95||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9500|0.5178|0.0220
91740643|NCT02651116|183373888|SUPERIORITY||Rate Ratio|0.7454|STANDARD_ERROR_OF_MEAN|0.0848||0.0098|TWO_SIDED|95.0|0.5964|0.9316||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9316|0.5964|0.0098
91740644|NCT02651116|183373889|SUPERIORITY||Difference in least squares mean|-0.221|STANDARD_ERROR_OF_MEAN|0.1324||0.0977|TWO_SIDED|95.0|-0.4831|0.0411||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANCOVA|||Analysis of covariance (ANCOVA) model contained treatment, study site (pooled), log-transformed baseline cough time and age group terms as factors.||0.0411|-0.4831|0.0977
91740645|NCT02651116|183373890|SUPERIORITY||Difference in least squares mean|-0.2881|STANDARD_ERROR_OF_MEAN|0.1224||0.0191|TWO_SIDED|95.0|-0.5287|-0.0475||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Analysis of variance (ANOVA) model contained treatment, study site (pooled), the corresponding morning baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0475|-0.5287|0.0191
91740646|NCT02651116|183373890|SUPERIORITY|||||||0.8355||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8355
91740647|NCT02651116|183373891|SUPERIORITY||Difference in least squares mean|-0.3128|STANDARD_ERROR_OF_MEAN|0.1104||0.0049|TWO_SIDED|95.0|-0.5299|-0.0956||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0956|-0.5299|0.0049
91740648|NCT02651116|183373891|SUPERIORITY|||||||0.8413||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8413
91740649|NCT02651116|183373892|SUPERIORITY||Difference in least squares mean|-0.1483|STANDARD_ERROR_OF_MEAN|0.1337||0.2679|TWO_SIDED|95.0|-0.4112|0.1146||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline impact on sleep by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||0.1146|-0.4112|0.2679
91740650|NCT02651116|183373892|SUPERIORITY|||||||0.2882||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2882
91740651|NCT02651116|183373893|SUPERIORITY||Difference in least squares mean|-0.2812|STANDARD_ERROR_OF_MEAN|0.1242||0.0242|TWO_SIDED|95.0|-0.5255|-0.0369||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0369|-0.5255|0.0242
91740652|NCT02651116|183373893|SUPERIORITY|||||||0.2892||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2892
91740653|NCT02651116|183373894|SUPERIORITY||Difference in least squares mean|-0.3014|STANDARD_ERROR_OF_MEAN|0.1096||0.0063|TWO_SIDED|95.0|-0.517|-0.0858||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0858|-0.5170|0.0063
91531179|NCT00826280|182939024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0037
91531180|NCT00826280|182939024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0089
91740654|NCT02651116|183373894|SUPERIORITY|||||||0.3268||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.3268
91740655|NCT02651116|183373895|SUPERIORITY||Difference in least squares mean|-0.2535|STANDARD_ERROR_OF_MEAN|0.1124||0.0247|TWO_SIDED|95.0|-0.4745|-0.0325||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model with treatment, study site (pooled), the baseline assessment in child global question cold assessment by participant and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0325|-0.4745|0.0247
91740656|NCT02651116|183373895|SUPERIORITY|||||||0.4093||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model with treatment, study site (pooled), baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.4093
91740657|NCT02651116|183373896|SUPERIORITY||Difference in least squares mean|0.1266|STANDARD_ERROR_OF_MEAN|0.2196||0.5652|TWO_SIDED|95.0|-0.3081|0.5614||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.5614|-0.3081|0.5652
91740658|NCT02651116|183373896|SUPERIORITY||Difference in least squares mean|-0.1368|STANDARD_ERROR_OF_MEAN|0.1982||0.4914|TWO_SIDED|95.0|-0.5292|0.2556||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.2556|-0.5292|0.4914
91740659|NCT02651116|183373896|SUPERIORITY|||||||0.1029||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.1029
91740660|NCT02651116|183373896|SUPERIORITY|||||||0.4736||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.4736
91740661|NCT02041299|183373919|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 96.01% confidence interval (CI) is less than or equal to 2 mg/g dw.|Mean Difference (Net)|0.26||||0.0399|TWO_SIDED|96.01|-0.97|1.48|||ANCOVA|||||1.48|-0.97|0.0399
91740662|NCT02041299|183373920|NON_INFERIORITY|Support for non-inferiority is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|-0.000295||||0.0399|TWO_SIDED|96.01|-0.054247|0.053657|||ANCOVA|||Data for this measure were log-transformed.||0.053657|-0.054247|0.0399
91531181|NCT00826280|182939024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0016
91740663|NCT02041299|183373921|NON_INFERIORITY|Support for non-inferiority of deferiprone to deferoxamine in serum ferritin is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|375.07||||0.0399|TWO_SIDED|96.01|-260.63|1010.76|||ANCOVA|||||1010.76|-260.63|0.0399
91740664|NCT02041299|183373922|SUPERIORITY|Comparison of treatment groups on change in score on SF-36 Physical Summary||||||0.9214|||||||ANCOVA|||||||0.9214
91740665|NCT02041299|183373922|SUPERIORITY|||||||0.1174|||||||ANCOVA|||Comparison of treatment groups on change in score on SF-36 Mental Summary||||0.1174
91740666|NCT02041299|183373922|SUPERIORITY|||||||0.6488|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Physical Summary||||0.6488
91740667|NCT02041299|183373922|SUPERIORITY|||||||0.5915|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Psychosocial Summary||||0.5915
91740668|NCT02389465|183373923|OTHER|||||||0.44|||||||t-test, 2 sided|||IL6 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.44
91740669|NCT02389465|183373923|OTHER|||||||0.11|||||||t-test, 2 sided|||IL6 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.11
91740670|NCT02389465|183373923|OTHER|||||||0.42|||||||t-test, 2 sided|||IL6 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.42
91740671|NCT02389465|183373923|OTHER|||||||0.49|||||||t-test, 2 sided|||IL-6 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-tes||||.49
91740672|NCT02389465|183373923|OTHER|||||||0.23|||||||t-test, 2 sided|||IL6 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.23
91740673|NCT02389465|183373924|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram + celecoxib groups||||.003
91740674|NCT02389465|183373924|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram groups||||<.001
91740675|NCT02389465|183373924|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and placebo groups||||.034
91740676|NCT02389465|183373924|SUPERIORITY|||||||0.03|||||||ANCOVA|||MADRS scores at the final visit compared between the placebo groups and all groups receiving escitalopram (both with and without celecoxib)||||.03
91740677|NCT02389465|183373925|OTHER|||||||0.29|||||||t-test, 2 sided|||IL10 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.29
91740678|NCT02389465|183373925|OTHER|||||||0.19|||||||t-test, 2 sided|||IL10 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.19
91740679|NCT02389465|183373925|OTHER|||||||0.5|||||||t-test, 2 sided|||IL10 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.5
91740680|NCT02389465|183373925|OTHER|||||||0.55|||||||t-test, 2 sided|||IL10 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-test||||.55
91740681|NCT02389465|183373925|OTHER|||||||0.06|||||||t-test, 2 sided|||IL10 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.06
91740682|NCT01925768|183373926|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.7||||0.004|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||29.3|6.2|0.0040
91740683|NCT01925768|183373927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.103||||0.1677|TWO_SIDED|95.0|-0.251|0.044|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||0.044|-0.251|0.1677
91740684|NCT01925768|183373928|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.5||||0.004|TWO_SIDED|95.0|6.3|30.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel|Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.|Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||30.6|6.3|0.0040
91740685|NCT01925768|183373929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.0051|TWO_SIDED|95.0|-0.85|-0.15|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.|||-0.15|-0.85|0.0051
91740686|NCT01925768|183373930|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.68||||0.0167|TWO_SIDED|95.0|0.49|4.88|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||4.88|0.49|0.0167
91740687|NCT01925768|183373931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4||||0.0039|TWO_SIDED|95.0|1.1|5.7||Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.|Mixed Models Analysis|||2-sided 95% CI for the difference in LS mean.||5.70|1.10|0.0039
91740688|NCT01925768|183373932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0||||0.012|TWO_SIDED|95.0|-21.5|10.2|||Sign test|p-value based on distribution free signed rank test||||10.2|-21.5|0.012
91740689|NCT01925768|183373933|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.7||||0.0016|TWO_SIDED|95.0|8.0|31.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||31.3|8.0|0.0016
91740690|NCT01925768|183373934|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.0229|TWO_SIDED|95.0|-0.279|-0.021|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.021|-0.279|0.0229
91740691|NCT01925768|183373935|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.35|-1.00|<0.0001
91740692|NCT01925768|183373936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.46||||0.0039|TWO_SIDED|95.0|1.13|5.8|||Mixed Models Analysis||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||5.80|1.13|0.0039
91740693|NCT01925768|183373937|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann|10.0||||0.0168|TWO_SIDED|95.0|0.0|20.0|||Stratified Van Elteren test|p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids|Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.|||20.0|0.0|0.0168
91740694|NCT01925768|183373938|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|20.7||||0.0015|TWO_SIDED|95.0|8.5|32.8||2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||32.8|8.5|0.0015
91740695|NCT01925768|183373939|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.7||||0.0252|TWO_SIDED|95.0|1.6|17.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average||17.7|1.6|0.0252
91740696|NCT01925768|183373939|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.6||||0.1121|TWO_SIDED|95.0|-1.7|18.9||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average||18.9|-1.7|0.1121
91740697|NCT01925768|183373939|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.8||||0.0036|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average||29.3|6.2|0.0036
91740698|NCT01925768|183373939|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.7||||0.0392|TWO_SIDED|95.0|0.8|24.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average||24.6|0.8|0.0392
91740699|NCT01925768|183373939|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.0||||0.0884|TWO_SIDED|95.0|-1.3|23.2||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average||23.2|-1.3|0.0884
91740700|NCT01925768|183373939|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.6||||0.004|TWO_SIDED|95.0|6.5|30.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average||30.7|6.5|0.0040
91740701|NCT03542266|183373956|OTHER||Proportion (percent)|75.0|||||TWO_SIDED|95.0|46.5|90.3|||||Exact (Clopper-Pearson) 95% confidence interval for complete response rate.|||90.3|46.5|
91740702|NCT00873821|183373974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.83|||<|0.001|TWO_SIDED|95.0|26.33|55.32|||Mixed Models Analysis|||Difference (placebo minus MK-0941) in change from baseline to Day 13||55.32|26.33|<0.001
91740703|NCT00444925|183373986|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).||||<0.0001
91740704|NCT00444925|183373986|SUPERIORITY_OR_OTHER|||||||0.0107||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0107
91740705|NCT00444925|183373986|SUPERIORITY_OR_OTHER|||||||0.0172||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0172
91740706|NCT00444925|183373987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91740707|NCT00444925|183373987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91740708|NCT00444925|183373987|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.8460
91740709|NCT00444925|183373987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91740710|NCT00444925|183373987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
91740711|NCT00444925|183373987|SUPERIORITY_OR_OTHER|||||||0.1937||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1937
91499775|NCT02848651|182869466|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3502|TWO_SIDED|90.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.3502
91740712|NCT00444925|183373988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
91740713|NCT00444925|183373988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
91740714|NCT00444925|183373988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91740715|NCT00444925|183373988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91740716|NCT00444925|183373988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740717|NCT00444925|183373988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
91499776|NCT02848651|182869473|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1783|TWO_SIDED|90.0|0.4|1.1|||Log Rank|||||1.10|0.40|0.1783
91740718|NCT00444925|183373988|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0220
91740719|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|3.4||0.0214|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0214
91499777|NCT02848651|182869473|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0358|TWO_SIDED|90.0|0.23|0.85|||Log Rank|||||0.85|0.23|0.0358
91499778|NCT02848651|182869474|SUPERIORITY||Differences in Rates|13.27||||0.0326|TWO_SIDED|90.0|2.53|24.0|||Cochran-Mantel-Haenszel|||||24.00|2.53|0.0326
91499779|NCT02848651|182869474|SUPERIORITY||Difference in Rates|30.22|||<|0.0001|TWO_SIDED|90.0|14.82|45.62|||Cochran-Mantel-Haenszel|||||45.62|14.82|<0.0001
91499780|NCT02848651|182869474|SUPERIORITY||Differences in Rates|41.37|||<|0.0001|TWO_SIDED|90.0|22.13|60.61|||Cochran-Mantel-Haenszel|||||60.61|22.13|<0.0001
91499781|NCT00680043|182869508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.79|0.29|||ANOVA|||||0.29|-0.79|
91499782|NCT00680043|182869508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.56|0.52|||ANOVA|||||0.52|-0.56|
91499783|NCT00680043|182869510|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.84|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.84|
91499784|NCT00680043|182869510|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.92|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.92|
91499785|NCT02480114|182869511|SUPERIORITY||Odds Ratio (OR)|0.549||||0.004|TWO_SIDED|95.0|0.364|0.827|||Proportional Odds Regression|||||0.827|0.364|0.004
91499786|NCT02480114|182869512|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
91499787|NCT02480114|182869513|SUPERIORITY||Odds Ratio (OR)|0.371|||<|0.001|TWO_SIDED|95.0|0.244|0.597|||Proportional Odds Regression|||||0.597|0.244|<0.001
91499788|NCT04203238|182869537|SUPERIORITY||Median Difference (Final Values)|0.89|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91499789|NCT01662908|182869538|OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|10.74|||TWO_SIDED|95.0|-12.7|30.2||||||||30.2|-12.7|
91740720|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.4||0.0149|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0149
91499790|NCT03510884|182869580|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-43.3|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-56.0|-30.7||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per interactive voice response system (IVRS), time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.7|-56.0|<0.0001
91499791|NCT03510884|182869580|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-46.4|-21.2||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.2|-46.4|<0.0001
91499792|NCT03510884|182869581|SUPERIORITY|Hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-45.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-56.3|-34.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-34.7|-56.3|<0.0001
91499793|NCT03510884|182869581|SUPERIORITY|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-41.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-52.7|-30.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.2|-52.7|<0.0001
91499794|NCT03510884|182869582|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|97.5|-47.5|-28.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-28.2|-47.5|<0.0001
91531182|NCT00826280|182939024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5654||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5654
91740721|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.8659|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.8659
91740722|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740723|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|4.0||0.0036|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0036
91740724|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.3||0.1484|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1484
91499795|NCT03510884|182869582|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-42.0|-19.4||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.4|-42.0|<0.0001
91499796|NCT03510884|182869583|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-40.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001|TWO_SIDED|97.5|-52.2|-29.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.1|-52.2|<0.0001
91499797|NCT03510884|182869583|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-31.9|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|97.5|-44.1|-19.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.7|-44.1|<0.0001
91499798|NCT03510884|182869584|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.8|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|97.5|-39.8|-21.9||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.9|-39.8|<0.0001
91499799|NCT03510884|182869584|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|97.5|-33.5|-13.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-13.1|-33.5|<0.0001
91499800|NCT03510884|182869585|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-38.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|97.5|-48.2|-29.6||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.6|-48.2|<0.0001
91499801|NCT03510884|182869585|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED|97.5|-42.8|-22.7|||MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-22.7|-42.8|<0.0001
91499802|NCT03510884|182869586|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-53.8|-31.8||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Non-HDL-C value and Baseline Non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-31.8|-53.8|<0.0001
91531183|NCT00826280|182939025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91740725|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740726|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|4.1||0.1029|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.1029
91740727|NCT00444925|183373989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|3.3||0.0048|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0048
91740728|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0002|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0002
91499803|NCT03510884|182869586|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|97.5|-47.9|-27.0||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-27.0|-47.9|<0.0001
91499804|NCT03510884|182869587|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|97.5|-41.3|-24.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-24.2|-41.3|<0.0001
91513590|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.9|-0.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.1|-1.9|< 0.001
91531184|NCT00826280|182939025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91740729|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0006|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0006
91740730|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7395|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7395
91740731|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740732|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0007|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0007
91740733|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4185|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.4185
91740734|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740735|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0005
91740736|NCT00444925|183373990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3798|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.3798
91499805|NCT03510884|182869587|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|97.5|-35.6|-20.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-20.2|-35.6|<0.0001
91740737|NCT00444925|183373991|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
91740738|NCT00444925|183373991|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0002
91740739|NCT00444925|183373991|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91740740|NCT00444925|183373991|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91740741|NCT00444925|183373991|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
91740742|NCT00444925|183373991|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0003
91740743|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.273|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.2730
91513591|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.8|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.6|-2.8|< 0.001
91740744|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0652|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0652
91740745|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.3503|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3503
91531185|NCT00826280|182939025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
91740746|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2667|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||0.2667
91740747|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1643|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.1643
91740748|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7264|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.7264
91740749|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3269|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||0.3269
91740750|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5059|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.5059
91740751|NCT00444925|183373992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.699|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.6990
91740752|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0008
91740753|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
91740754|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.382|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3820
91740755|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740756|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
91740757|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3498|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3498
91740758|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740759|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
91740760|NCT00444925|183373994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0542|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0542
91531186|NCT00826280|182939025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4246||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||.4246
91531187|NCT04731714|182939029|SUPERIORITY|||||||0.0104|||||||Mixed Models Analysis|See publication for details||||||0.0104
91531188|NCT04731714|182939030|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|See publication for details||||||0.079
91531189|NCT04731714|182939031|SUPERIORITY|||||||0.9222|||||||Mixed Models Analysis|See publication for details||||||0.9222
91740761|NCT00444925|183373995|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0004
91740762|NCT00444925|183373995|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
91740763|NCT00444925|183373995|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91499806|NCT03510884|182869588|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|77.6|||=|0.0001|TWO_SIDED|97.5|6.3|960.0||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||960.0|6.3|=0.0001
91499807|NCT03510884|182869588|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|14.9|||<|0.0001|TWO_SIDED|97.5|3.2|69.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||69.8|3.2|<0.0001
91531190|NCT04731714|182939032|SUPERIORITY|||||||0.7995|||||||Mixed Models Analysis|See publication for details||||||0.7995
91531191|NCT04731714|182939033|OTHER|||||||0.314||||||rhythmic days|Friedman Test|See publication for further details||||||0.3140
91531192|NCT04731714|182939033|OTHER|||||||0.239||||||arrhythmic days|Friedman Test|See publication for further details||||||0.239
91499808|NCT03510884|182869589|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|26.5|||<|0.0001|TWO_SIDED|97.5|4.0|174.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||174.8|4.0|<0.0001
91499809|NCT03510884|182869589|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|40.9|||<|0.0001|TWO_SIDED|97.5|5.7|290.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||290.9|5.7|<0.0001
91499810|NCT03510884|182869590|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|52.7|||=|0.0011|TWO_SIDED|97.5|3.5|804.3||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||804.3|3.5|=0.0011
91531193|NCT04731714|182939037|SUPERIORITY|||||||0.8844|||||||Mixed Models Analysis|See publication for details||||||0.8844
91531194|NCT04731714|182939039|OTHER|||||||0.73|||||||binomial|One-sided||||||0.73
91531195|NCT03354637|182939050|SUPERIORITY||Mean Difference (Final Values)|13.88|STANDARD_ERROR_OF_MEAN|4.707||0.038|TWO_SIDED|95.0|0.77|27.0||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||27.00|0.77|0.038
91531196|NCT03354637|182939050|SUPERIORITY||Mean Difference (Final Values)|9.32|STANDARD_ERROR_OF_MEAN|4.784||0.166|TWO_SIDED|95.0|-3.9|22.55||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||22.55|-3.90|0.166
91740764|NCT00444925|183373995|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91531197|NCT03354637|182939051|SUPERIORITY||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.511||0.302|TWO_SIDED|95.0|-5.97|19.17|||Mixed Models Analysis|||||19.17|-5.97|0.302
91740765|NCT00444925|183373995|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
91740766|NCT00444925|183373995|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
91740767|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
91531198|NCT03354637|182939051|SUPERIORITY||Mean Difference (Final Values)|3.23|STANDARD_ERROR_OF_MEAN|4.584||0.616|TWO_SIDED|95.0|-9.44|15.9|||Mixed Models Analysis|||||15.90|-9.44|0.616
91740768|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
91740769|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5581|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5581
91740770|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740771|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
91740772|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.151|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1510
91740773|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740774|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0001
91740775|NCT00444925|183373996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1391|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1391
91740776|NCT00444925|183373997|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
91740777|NCT00444925|183373997|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
91740778|NCT00444925|183373997|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91740779|NCT00444925|183373997|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
91760114|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.38|0.41||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.41|-0.38|
91531199|NCT03354637|182939052|SUPERIORITY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.074||0.125|TWO_SIDED|95.0|-1.26|10.3|||Mixed Models Analysis|||||10.30|-1.26|0.125
91531200|NCT03354637|182939052|SUPERIORITY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|2.107||0.234|TWO_SIDED|95.0|-2.3|9.36|||Mixed Models Analysis|||||9.36|-2.30|0.234
91740780|NCT00444925|183373997|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
91740781|NCT00444925|183373997|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
91740782|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
91740783|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
91740784|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5972|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5972
91740785|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740786|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
91740787|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.1267|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1267
91740788|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740789|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
91740790|NCT00444925|183373998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0289|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0289
91740791|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
91740792|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
91513592|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.6|1.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-1.6|< 0.001
91531201|NCT03354637|182939053|SUPERIORITY||Mean Difference (Final Values)|1.55|STANDARD_ERROR_OF_MEAN|2.131||0.607|TWO_SIDED|95.0|-4.39|7.49|||Mixed Models Analysis|||||7.49|-4.39|0.607
91740793|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.6||0.7288|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7288
91740794|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740795|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
91740796|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2473|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.2473
91740797|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740798|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
91740799|NCT00444925|183373999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1047|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1047
91740800|NCT00444925|183374000|SUPERIORITY_OR_OTHER|||||||0.0143||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0143
91531202|NCT03354637|182939053|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.165||0.981|TWO_SIDED|95.0|-6.06|5.92|||Mixed Models Analysis|||||5.92|-6.06|0.981
91740801|NCT00444925|183374000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||<0.0001
91740802|NCT00444925|183374000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||<0.0001
91740803|NCT00444925|183374001|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0773
91740804|NCT00444925|183374001|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||0.0017
91740805|NCT00444925|183374001|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||0.0008
91740806|NCT00444925|183374002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment difference Fesoterodine vs placebo at Week 12||||<0.0001
91740807|NCT00444925|183374003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||||<0.0001
91740808|NCT00444925|183374003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||||<0.0001
91531203|NCT03354637|182939054|SUPERIORITY||Odds Ratio (OR)|1.4||||0.62|TWO_SIDED|95.0|0.4|4.6|||Mixed Models Analysis|||||4.6|0.4|0.620
91531204|NCT03354637|182939054|SUPERIORITY||Odds Ratio (OR)|1.7||||0.366|TWO_SIDED|95.0|0.5|5.8|||Mixed Models Analysis|||||5.8|0.5|0.366
91531205|NCT03354637|182939055|SUPERIORITY||Odds Ratio (OR)|0.1||||0.157|TWO_SIDED|95.0|0.0|2.3|||Mixed Models Analysis|||||2.3|0.0|0.157
91499811|NCT03510884|182869590|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|43.1|||=|0.0006|TWO_SIDED|97.5|3.7|498.6||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||498.6|3.7|=0.0006
91513593|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.7|-2.6|< 0.001
91531206|NCT03354637|182939055|SUPERIORITY||Odds Ratio (OR)|0.4||||0.353|TWO_SIDED|95.0|0.1|2.8|||Mixed Models Analysis|||||2.8|0.1|0.353
91740809|NCT00444925|183374003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|1.5||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||||0.0008
91740810|NCT00444925|183374003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||||<0.0001
91740811|NCT00444925|183374003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||||<0.0001
91740812|NCT00444925|183374004|SUPERIORITY_OR_OTHER|||||||0.0072||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0072
91740813|NCT00444925|183374004|SUPERIORITY_OR_OTHER|||||||0.0116||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0116
91740814|NCT00444925|183374004|SUPERIORITY_OR_OTHER|||||||0.7828||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7828
91740815|NCT00444925|183374004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
91740816|NCT00444925|183374004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
91740817|NCT00444925|183374004|SUPERIORITY_OR_OTHER|||||||0.3104||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3104
91740818|NCT00444925|183374004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
91740819|NCT00444925|183374004|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0004
91740820|NCT00444925|183374004|SUPERIORITY_OR_OTHER|||||||0.0153||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0153
91740821|NCT00833027|183374005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.85|<|0.001|ONE_SIDED|95.0|||||Student's T-test|Student's T-test for paired samples||||||<0.001
91740822|NCT02881775|183374009|SUPERIORITY|||||||0.9994||||||The threshold for significance was P \<.05|ANOVA|"Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors.~Degrees of freedom (DF) = 34.1"||Comparison of CAR BL Change (treatment by time)||||.9994
91740823|NCT02881775|183374010|SUPERIORITY|||||||0.9768||||||The threshold for statistical significance was p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of MVIC BL Change (treatment by time)||||.9768
91740824|NCT02881775|183374011|SUPERIORITY|||||||0.444||||||threshold for statistical significance is p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 43.1||Comparison of NPRS BL Change (treatment by time)||||0.4440
91740825|NCT02881775|183374012|SUPERIORITY|||||||0.6608||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||PPT BL Change (treatment by time)||||.6608
91740826|NCT02881775|183374013|SUPERIORITY|||||||0.7706||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of TUG BL Change (treatment by time)||||.7706
91740827|NCT02881775|183374014|SUPERIORITY|||||||0.3665||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of AMT-MEP BL Change (treatment by time)||||.3665
91740828|NCT02881775|183374015|SUPERIORITY|||||||0.3889||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of SICI BL Change (treatment by time)||||.3889
91740829|NCT02881775|183374016|SUPERIORITY|||||||0.2192||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of ICF BL Change (treatment by time)||||.2192
91499812|NCT03510884|182869591|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|6.6||The percentage of participants reaching LDL-C level lower than 110 mg/dL was 0% in the placebo arm, as a result it was possible to derive the estimated odds-ratio, but the estimated confidence interval (CI) was very wide, with the upper limit estimated to Infinity, therefore upper limit of 97.5% CI was not available to report.|Threshold for significance at 0.025 level.|Exact conditional logistic regression||Alirocumab Q2W versus Placebo Q2W: Odds ratios and confidence intervals estimated from exact conditional logistic regression model.|The LOCF approach followed by exact conditional logistic regression model. The exact conditional logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the quartiles of the Baseline LDL-C value.|||6.6|<0.0001
91499813|NCT03510884|182869591|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|104.8|||=|0.0005|TWO_SIDED|97.5|5.2|2095.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||2095.9|5.2|=0.0005
91499814|NCT03510884|182869592|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-15.2|STANDARD_ERROR_OF_MEAN|6.7|=|0.0237|TWO_SIDED|97.5|-30.3|-0.1||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-0.1|-30.3|=0.0237
91499815|NCT03510884|182869592|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-24.9|STANDARD_ERROR_OF_MEAN|8.7|=|0.0043|TWO_SIDED|97.5|-44.4|-5.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-5.4|-44.4|=0.0043
91531207|NCT03354637|182939056|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
91531208|NCT03354637|182939056|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
91531209|NCT03354637|182939057|SUPERIORITY||Odds Ratio (OR)|0.7||||0.435|TWO_SIDED|95.0|0.3|1.8|||Mixed Models Analysis|||||1.8|0.3|0.435
91531210|NCT03354637|182939057|SUPERIORITY||Odds Ratio (OR)|0.6||||0.37|TWO_SIDED|95.0|0.2|1.7|||Mixed Models Analysis|||||1.7|0.2|0.370
91740830|NCT00237042|183374040|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Regression, Linear|Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.||The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.||||0.19
91740831|NCT00237042|183374041|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.27
91740832|NCT00237042|183374042|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Linear|Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.||The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.||||0.003
91740833|NCT00237042|183374043|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.016
91531211|NCT03354637|182939058|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
91531212|NCT03354637|182939058|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
91531213|NCT03354637|182939059|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
91740834|NCT04522167|183374062|EQUIVALENCE|If the confidence interval for difference in LSMeans is completely contained in the interval \]-3.5 letters; 3.5 letters\[, FBY203 and Eylea are considered equivalent.|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.4|-0.3|2.2||||||||2.2|-0.3|
91740835|NCT02197572|183374094|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.2||||||Change from Baseline at 0.25 Hours Postdose||2.2||
91740836|NCT02197572|183374094|OTHER||Least Squares Mean|-8.3|||||ONE_SIDED|95.0||-4.0||||||Change from Baseline at 0.5 Hours Postdose||-4.0||
91740837|NCT02197572|183374094|OTHER||Least Squares Mean|-1.8|||||ONE_SIDED|95.0||2.6||||||Change from Baseline at 1 Hour Postdose||2.6||
91740838|NCT02197572|183374094|OTHER||Least Squares Mean|-2.7|||||ONE_SIDED|95.0||1.7||||||Change from Baseline at 1.5 Hours Postdose||1.7||
91740839|NCT02197572|183374094|OTHER||Least Squares Mean|-5.0|||||ONE_SIDED|95.0||-0.6||||||Change from Baseline at 2 Hours Postdose||-0.6||
91740840|NCT02197572|183374094|OTHER||Least Squares Mean|-7.6|||||ONE_SIDED|95.0||-3.2||||||Change from Baseline at 2.5 Hours Postdose||-3.2||
91740841|NCT02197572|183374094|OTHER||Least Squares Mean|-9.1|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 3 Hours Postdose||-4.6||
91740842|NCT02197572|183374094|OTHER||Least Squares Mean|-7.2|||||ONE_SIDED|95.0||-2.9||||||Change from Baseline at 4 Hours Postdose||-2.9||
91740843|NCT02197572|183374094|OTHER||Least Squares Mean|-8.8|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 6 Hours Postdose||-4.6||
91740844|NCT02197572|183374094|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.4||||||Change from Baseline at 8 Hours Postdose||2.4||
91740845|NCT02197572|183374094|OTHER||Least Squares Mean|-6.6|||||ONE_SIDED|95.0||-0.5||||||Change from Baseline at 10 Hours Postdose||-0.5||
91740846|NCT02197572|183374094|OTHER||Least Squares Mean|7.1|||||ONE_SIDED|95.0||11.4||||||Change from Baseline at 24 Hours Postdose||11.4||
91740847|NCT02197572|183374094|OTHER||Least Squares Mean|2.8|||||ONE_SIDED|95.0||8.1||||||Change from Baseline at 48 Hours Postdose||8.1||
91499816|NCT03510884|182869593|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-5.6|STANDARD_ERROR_OF_MEAN|7.1|=|0.4288|TWO_SIDED|97.5|-21.7|10.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||10.4|-21.7|=0.4288
91740848|NCT02383862|183374108|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.79||0.165|TWO_SIDED|95.0|-0.45|2.64|||t-test, 2 sided|||||2.64|-0.45|0.165
91740849|NCT02383862|183374109|SUPERIORITY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|1.05||0.425|TWO_SIDED|95.0|-1.23|2.91|||t-test, 2 sided|||||2.91|-1.23|0.425
91740850|NCT02383862|183374110|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|1.05||0.539|TWO_SIDED|95.0|-1.41|2.7|||t-test, 2 sided|||||2.70|-1.41|0.539
91740851|NCT02383862|183374111|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|1.16||0.471|TWO_SIDED|95.0|-1.44|3.11|||t-test, 2 sided|||||3.11|-1.44|0.471
91740852|NCT02383862|183374112|SUPERIORITY||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.1||0.174|TWO_SIDED|95.0|-0.66|3.65|||t-test, 2 sided|||||3.65|-0.66|0.174
91740853|NCT02383862|183374113|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|1.36||0.222|TWO_SIDED|95.0|-1.0|4.35|||t-test, 2 sided|||||4.35|-1.00|0.222
91740854|NCT02763059|183374163|OTHER|Kruskal-Wallis||||||0.027||||||Kruskal-Wallis test, a non-parametric omnibus test, was used followed by Dunn's multiple comparison test for pairwise group analysis. A priori threshold for statistical significance was set at p \< 0.05 with no adjustments for multiple comparisons.|Kruskal-Wallis|||The Kruskal-Wallis test is an omnibus test comparing all three independent groups.||||0.027
91740855|NCT02763059|183374163|OTHER|Kruskal-Wallis|||||<|0.0001||||||Kruskal-Wallis test, a non-parametric omnibus test, was used followed by Dunn's multiple comparison test for pairwise group analysis. A priori threshold for statistical significance was set at p \< 0.05 with no adjustments for multiple comparisons.|Kruskal-Wallis|||The Kruskal-Wallis test is an omnibus test comparing all three independent groups on the pain/discomfort outcome.||||<0.0001
91740856|NCT02933879|183374232|SUPERIORITY|||||||0.4615|||||||Z-test, 2 sided|||||||0.4615
91740857|NCT02933879|183374234|SUPERIORITY|||||||0.0404|||||||Z-test, 2 sided|||||||0.0404
91740858|NCT02933879|183374234|SUPERIORITY|||||||0.2106|||||||Z-test, 2 sided|||||||0.2106
91740859|NCT02933879|183374236|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
91740860|NCT02933879|183374238|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
91740861|NCT02933879|183374241|SUPERIORITY|||||||0.2467|||||||Z-test, 2 sided|||||||0.2467
91740862|NCT00075764|183374247|OTHER||Hazard Ratio (HR)|0.8||||0.007|TWO_SIDED|95.0|0.68|0.94|||Log Rank|Two-sided stratified log-rank test||||0.94|0.68|0.007
91740863|NCT00075764|183374249|OTHER||Hazard Ratio (HR)|0.81||||0.049|TWO_SIDED|95.0|0.65|1.0|||Log Rank|A log-rank test, stratified according to prior or no prior tamoxifen therapy.||||1.00|0.65|0.049
91740864|NCT00533429|183374262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||||||P-value (one-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.469
91740865|NCT00533429|183374263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.462||||||95% confidence interval based on normal approximation to the binomial distribution. P-value (2-tailed) calculation based on unadjusted, normal-distribution approximation for the difference in rates.|Fisher Exact|||||||0.462
91740866|NCT00533429|183374264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||||||P-value (two-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.492
91740867|NCT02655887|183374268|NON_INFERIORITY|PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Weighted Z-statistics|88.3||||0.0001|ONE_SIDED|90.0|82.4||||Weighted Z-statistics|||"Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG.~Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG."|||82.4|0.0001
91740868|NCT02655887|183374269|NON_INFERIORITY|The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Exact binomial test|93.5||||0.0322|ONE_SIDED|90.0|89.5||||Exact binomial test|||"Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG.~Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG."|||89.5|0.0322
91740869|NCT02655887|183374270|OTHER|||||||0.001||||||this p value is \< 0.001.|t-test, 2 sided|||"H0: The distribution at the 12-month follow-up remains unimproved compared to baseline.~Ha: The distribution shifts toward lower (less pain) classes."||||0.001
91740870|NCT02655887|183374271|OTHER|||||||0.001||||||p value is \< 0.001|t-test, 2 sided|||||||0.001
91740871|NCT01964378|183374308|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming equal mean values in both the cebranopadol and morphine groups, it was calculated that for the final analysis of the primary endpoint 170 subjects would have been required per treatment arm in the Per Protocol Set using a 2 sample-t-test for 90% power and a 1-sided significance level of α = 0.025.|point-estimate|-7.48|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-12.05|-2.918|||MMRM|||The MMRM (mixed model repeated measurement) model includes fixed effects of pooled country, treatment, week, treatment-by-week interaction, history of opioid intake, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable being the weekly average rescue medication intake.||-2.918|-12.05|< 0.0001
91740872|NCT01964378|183374309|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming that 65% of the participants are available for the Per Protocol Set, a total of 524 participant would have to be allocated (randomized) to IMP. With 262 participants per group in the Full Analysis Set, the non-inferiority of cebranopadol as compared to morphine sulfate prolonged release could have been demonstrated with at least 98% power and a 1-sided significance level of α = 0.025.|point-estimate|-4.67|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-9.245|-0.099||MMRM model: fixed effects of pooled country, treatment, week, treatment-by-week interaction, opioid intake history, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable: weekly average rescue medication intake.|MMRM (mixed model repeated measurement)|For participants with no data in the Maintenance Phase, the average amount of rescue medication over the last 3 days of titration was imputed.|Non-inferiority of cebranopadol compared with morphine will be established if the upper bound of the resulting 95% confidence interval for the average treatment difference is below the non-inferiority margin of 8mg.|The primary endpoint will be analyzed by means of a mixed-effects model for repeated measures (MMRM), based on observed case weekly averages. Under the assumption of a missing-at-random missing data mechanism, an MMRM does not require an imputation of missing data and can obtain an improved estimate of variance.||-0.099|-9.245|< 0.0001
91740873|NCT02358993|183374322|NON_INFERIORITY|Non-inferiority of the primary outcome was achieved if the lower limit of the 95% confidence interval of the mean difference was greater than the specified non-inferiority margin of 15%(a clinically relevant margin within the range of those commonly used in non-inferiority and equivalence trials for studies examining antibiotic use for UTI)|Risk Ratio (RR)|-0.01|||||TWO_SIDED|95.0||||||||||||
91740874|NCT01072136|183374336|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption of a clinical cure proportion of 75% for the Azithromycin/Cefixime group, a 10% non-inferiority margin (i.e., no more than a 10% lower cure rate in the placebo group) at the one-sided 0.05 significance level with 85% power required 270 study participants in each arm (540 total) using an unpooled Z-test (normal approximation). Anticipating that approximately 30% of enrolled participants would not be in the per protocol group, 772 participants were targeted for enrollment.|Risk Difference (RD)|14.0|||||ONE_SIDED|95.0|-12.2||||||Asymptotic one-sided 95% confidence limit for the difference in clinical cure proportions(placebo minus treatment) were computed so that the lower limit could be examined relative to the non-inferiority margin of -10%.|The primary efficacy outcome was MPC clinical cure at 2 months. This was a non-inferiority trial designed to reject the null hypothesis that placebo control is inferior to empiric therapy for MPC.|||-12.2|
91740875|NCT00405288|183374352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|STANDARD_DEVIATION|450.0||0.17|TWO_SIDED|95.0|0.0|200.0|||t-test, 2 sided|||"Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.~To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups."||200|0|0.17
91740876|NCT00405288|183374353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.0||0.16|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|0|0.16
91740877|NCT00405288|183374354|SUPERIORITY_OR_OTHER||chi square|30.0||||0.003||95.0|||||McNemar|||The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).||||0.003
91740878|NCT00405288|183374355|SUPERIORITY_OR_OTHER||chi square|5.0||||0.55||95.0|||||McNemar|||The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.||||0.55
91740879|NCT00405288|183374356|SUPERIORITY_OR_OTHER||chi square|10.0||||0.97||95.0|||||McNemar|||Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.||||0.97
91740880|NCT00405288|183374357|SUPERIORITY_OR_OTHER||binary|3.0||||0.31||95.0|||||McNemar|||Low birth weight \<2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.||||0.31
91740881|NCT00405288|183374358|SUPERIORITY_OR_OTHER||chi square|10.0||||0.87||95.0|||||McNemar|||The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.||||0.87
91740882|NCT00405288|183374359|SUPERIORITY_OR_OTHER||proportion|4.0||||0.99||95.0|||||Fisher Exact|||||||0.99
91740883|NCT00405288|183374360|SUPERIORITY_OR_OTHER||proportion|3.0||||0.99||95.0|||||Fisher Exact|||||||0.99
91740884|NCT00405288|183374361|SUPERIORITY_OR_OTHER||proportion|2.0||||0.99||95.0|||||Fisher Exact|||||||0.99
91740885|NCT00405288|183374362|SUPERIORITY_OR_OTHER||proportions|2.0||||0.35||95.0|||||Fisher Exact|||||||0.35
91740886|NCT00142792|183374364|SUPERIORITY_OR_OTHER|||||||0.18||||||Time by group interaction effect, F(2,372) = 1.8, p =0.18)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.||||0.18
91740887|NCT00142792|183374364|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=87.7, p\<0.001)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
91740888|NCT00142792|183374365|SUPERIORITY_OR_OTHER|||||||0.27||||||time by group interaction effect, F(2,373) = 1.3, p =0.27|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||0.27
91740889|NCT00142792|183374365|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=91.1, p\<0.001|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
91740890|NCT00480740|183374375|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state \[dexmedetomidine + sevoflurane\]-baseline \[sevoflurane0\]/baseline \[sevoflurane\]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.||||||0.05||95.0||||The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.|t-test, 2 sided|||||||0.05
91740891|NCT04951622|183374382|SUPERIORITY||Difference of LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.47|=|0.002|TWO_SIDED|95.0|-2.38|-0.52|||mixed effects model for repeated measure|||||-0.52|-2.38|=0.002
91740892|NCT02891226|183374431|SUPERIORITY||Odds Ratio (OR)|2.75||||0.079|TWO_SIDED|90.0|1.07|7.08|||Regression, Logistic|||||7.08|1.07|0.079
91740893|NCT02891226|183374431|SUPERIORITY||Odds Ratio (OR)|4.92||||0.003|TWO_SIDED|90.0|2.01|12.07|||Regression, Logistic|||||12.07|2.01|0.003
91740894|NCT02891226|183374431|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.001|TWO_SIDED|90.0|2.81|13.42|||Regression, Logistic|||||13.42|2.81|<0.001
91740895|NCT02891226|183374432|SUPERIORITY||Odds Ratio (OR)|4.31||||0.241|TWO_SIDED|90.0|0.55|33.58|||Regression, Logistic|||||33.58|0.55|0.241
91740896|NCT02891226|183374432|SUPERIORITY||Odds Ratio (OR)|11.16||||0.032|TWO_SIDED|90.0|1.76|70.64|||Regression, Logistic|||||70.64|1.76|0.032
91740897|NCT02891226|183374432|SUPERIORITY||Odds Ratio (OR)|16.04||||0.009|TWO_SIDED|90.0|2.82|91.32|||Regression, Logistic|||||91.32|2.82|0.009
91499817|NCT03510884|182869593|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-13.5|STANDARD_ERROR_OF_MEAN|8.6|=|0.1148|TWO_SIDED|97.5|-32.7|5.7||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||5.7|-32.7|=0.1148
91499818|NCT00157950|182869623|SUPERIORITY_OR_OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.6|99.8|||||Exact binomial confidence interval|||99.8|93.6|
91499819|NCT00157950|182869624|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|100.0|||||TWO_SIDED|95.0|96.8|100.0|||||Exact binomial confidence interval|||100|96.8|
91740898|NCT02891226|183374433|SUPERIORITY||Odds Ratio (OR)|2.0||||0.33|TWO_SIDED|90.0|0.62|6.45|||Regression, Logistic|||||6.45|0.62|0.330
91740899|NCT02891226|183374433|SUPERIORITY||Odds Ratio (OR)|5.72||||0.006|TWO_SIDED|90.0|2.02|16.21|||Regression, Logistic|||||16.21|2.02|0.006
91740900|NCT02891226|183374433|SUPERIORITY||Odds Ratio (OR)|3.52||||0.029|TWO_SIDED|90.0|1.37|9.07|||Regression, Logistic|||||9.07|1.37|0.029
91740901|NCT02891226|183374434|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.234||0.007|TWO_SIDED|90.0|-1.03|-0.25|||Mixed Models Analysis|||||-0.25|-1.03|0.007
91740902|NCT02891226|183374434|SUPERIORITY||LS Mean difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.21|-0.45|||Mixed Models Analysis|||||-0.45|-1.21|<0.001
91740903|NCT02891226|183374434|SUPERIORITY||LS Mean difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.188||0.005|TWO_SIDED|90.0|-0.84|-0.22|||Mixed Models Analysis|||||-0.22|-0.84|0.005
91740904|NCT02891226|183374436|SUPERIORITY||LS Mean difference (Final Values)|24.05|STANDARD_ERROR_OF_MEAN|6.358|<|0.001|TWO_SIDED|90.0|13.53|34.56|||Mixed Models Analysis|||||34.56|13.53|<0.001
91740905|NCT02891226|183374436|SUPERIORITY||LS Mean difference (Final Values)|29.46|STANDARD_ERROR_OF_MEAN|6.421|<|0.001|TWO_SIDED|90.0|18.84|40.08|||Mixed Models Analysis|||||40.08|18.84|<0.001
91740906|NCT02891226|183374436|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|5.185|<|0.001|TWO_SIDED|90.0|16.67|33.82|||Mixed Models Analysis|||||33.82|16.67|<0.001
91740907|NCT02891226|183374437|SUPERIORITY||LS Mean difference (Final Values)|7.91|STANDARD_ERROR_OF_MEAN|2.072|<|0.001|TWO_SIDED|90.0|4.48|11.34|||Mixed Models Analysis|||||11.34|4.48|<0.001
91740908|NCT02891226|183374437|SUPERIORITY||LS Mean difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.102||0.004|TWO_SIDED|90.0|2.72|9.67|||Mixed Models Analysis|||||9.67|2.72|0.004
91740909|NCT02891226|183374437|SUPERIORITY||LS Mean difference (Final Values)|6.73|STANDARD_ERROR_OF_MEAN|1.686|<|0.001|TWO_SIDED|90.0|3.94|9.51|||Mixed Models Analysis|||||9.51|3.94|<0.001
91740910|NCT02891226|183374438|SUPERIORITY||LS Mean difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|1.927||0.008|TWO_SIDED|90.0|1.95|8.32|||Mixed Models Analysis|||Mental Component Summary (MCS)||8.32|1.95|0.008
91740911|NCT02891226|183374438|SUPERIORITY||LS Mean difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|1.951||0.033|TWO_SIDED|90.0|0.96|7.41|||Mixed Models Analysis|||Mental Component Summary (MCS)||7.41|0.96|0.033
91740912|NCT02891226|183374438|SUPERIORITY||LS Mean difference (Final Values)|3.71|STANDARD_ERROR_OF_MEAN|1.589||0.021|TWO_SIDED|90.0|1.08|6.34|||Mixed Models Analysis|||Mental Component Summary (MCS)||6.34|1.08|0.021
91740913|NCT02891226|183374438|SUPERIORITY||LS Mean difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.319||0.229|TWO_SIDED|90.0|-0.59|3.77|||Mixed Models Analysis|||Physical Component Summary (PCS)||3.77|-0.59|0.229
91740914|NCT02891226|183374438|SUPERIORITY||LS Mean difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|1.349|<|0.001|TWO_SIDED|90.0|2.67|7.14|||Mixed Models Analysis|||Physical Component Summary (PCS)||7.14|2.67|<0.001
91740915|NCT02891226|183374438|SUPERIORITY||LS Mean difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|1.078||0.001|TWO_SIDED|90.0|1.81|5.38|||Mixed Models Analysis|||Physical Component Summary (PCS)||5.38|1.81|0.001
91740916|NCT01445847|183374448|SUPERIORITY_OR_OTHER||Percentage|5.0|||<|0.05|TWO_SIDED|95.0|1.7|9.1|||Comparison of proportions|||We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) - percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 \> µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.||9.1|1.7|<0.05
91740917|NCT04570384|183374449|OTHER||Hazard Ratio (HR)|1.14||||0.782|TWO_SIDED|95.0|0.45|2.86|||Log Rank|||||2.86|0.45|0.782
91740918|NCT04570384|183374449|OTHER||Odds Ratio (OR)|1.25||||0.668|TWO_SIDED|95.0|0.46|3.4|||Regression, Logistic|||||3.40|0.46|0.668
91740919|NCT04570384|183374450|OTHER||Hazard Ratio (HR)|1.58||||0.36|TWO_SIDED|95.0|0.59|4.22|||Log Rank|||||4.22|0.59|0.360
91740920|NCT04570384|183374451|OTHER||Hazard Ratio (HR)|0.49||||0.285|TWO_SIDED|95.0|0.13|1.83|||Log Rank|||||1.83|0.13|0.285
91740921|NCT04570384|183374451|OTHER||Odds Ratio (OR)|0.6||||0.471|TWO_SIDED|95.0|0.15|2.41|||Regression, Logistic|||||2.41|0.15|0.471
91740922|NCT04570384|183374457|OTHER||Odds Ratio, log|0.81||||0.668|TWO_SIDED|95.0|0.3|2.2|||Zero-inflated negative binomial analyses|||||2.20|0.30|0.668
91499820|NCT00157950|182869625|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.2|100.0|||||Exact binomial confidence interval|||100|95.2|
91740923|NCT04570384|183374457|OTHER||Incidence Rate Ratio|0.66||||0.437|TWO_SIDED|95.0|0.23|1.9|||Zero-inflated negative binomial analyses|||||1.90|0.23|0.437
91740924|NCT04570384|183374458|OTHER||Odds Ratio (OR)|0.35||||0.232|TWO_SIDED|95.0|0.06|1.97|||Regression, Logistic|||||1.97|0.06|0.232
91740925|NCT04570384|183374459|OTHER||Odds Ratio (OR)|0.84||||0.729|TWO_SIDED|95.0|0.31|2.28|||Regression, Logistic|||||2.28|0.31|0.729
91740926|NCT04570384|183374460|OTHER||Odds Ratio, log|1.22||||0.706|TWO_SIDED|95.0|0.43|3.44|||Zero-inflated negative binomial analyses|||||3.44|0.43|0.706
91499821|NCT00157950|182869626|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.0|100.0|||||Exact binomial confidence interval|||100|95.0|
91499822|NCT01287897|182869648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|10.5||0.3406|TWO_SIDED|90.0|-13.0|21.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|Generalized linear mixed model (GLMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||21.7|-13.0|0.3406
91740927|NCT04570384|183374460|OTHER||Incidence Rate Ratio|1.12||||0.788|TWO_SIDED|95.0|0.49|2.56|||Zero-inflated negative binomial analyses|||||2.56|0.49|0.788
91740928|NCT04570384|183374461|OTHER||Incidence Rate Ratio|1.08||||0.834|TWO_SIDED|95.0|0.52|2.25|||Negative binomial analysis|||||2.25|0.52|0.834
91740929|NCT00326001|183374522|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value not adjusted for multiple comparisons|t-test, 2 sided|||||||0.25
91740930|NCT00326001|183374523|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Chi-squared|||||||0.042
91740931|NCT00326001|183374524|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||||||0.53
91740932|NCT00326001|183374525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91740933|NCT03265145|183374526|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.87|1.72|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||1.72|0.87|
91740934|NCT03265145|183374527|OTHER||adjusted annual rate ratio|1.41|||||TWO_SIDED|95.0|0.97|2.04|||||Ratio: Stiolto Respimat/triple therapy|||2.04|0.97|
91740935|NCT03265145|183374528|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.62|2.0|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||2.00|0.62|
91740936|NCT03265145|183374529|OTHER||adjusted annual rate ratio|1.08|||||TWO_SIDED|95.0|0.58|2.01|||||Ratio: Stiolto Respimat/triple therapy|||2.01|0.58|
91740937|NCT03265145|183374530|OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Ratio (RR) (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||1.64|0.89|
91740938|NCT03265145|183374530|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.022|0.094|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Difference (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||0.094|-0.022|
91740939|NCT02137070|183374531|SUPERIORITY||||||<|0.01||||||Voxel-size (p-FWE \< 0.01) and voxel-peak (p-unc \< 0.001) were corrected for multiple comparisons.|2x2 Factorial ANOVA in CONN|2x2 Factorial ANOVA in CONN - Group (Bariatric surgery vs. control) \& time (pre-surgery baseline vs. 18-month follow-up)||Analysis of variance comparing change scores from 18 months post-surgery relative to pre-surgical baseline were performed. Change in the surgical group was compared to change for the non-surgical controls. The dependent measures were connectivity strengths seeding from the hippocampus and left dorsal lateral pre-frontal cortex to other cortical areas.||||<0.01
91740940|NCT03046927|183374540|EQUIVALENCE|p values were obtained using generalized linear model with GEE for repeated measures.|Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED||||||generalized linear model with dependent||Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.001
91740941|NCT03046927|183374541|OTHER||trend analysis|0.04|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.01
91531214|NCT03354637|182939059|SUPERIORITY|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
91740942|NCT03046927|183374542|OTHER|p values were derived from trend analysis using generalized linear models|Mean Difference (Net)|0.507||||0.0241|TWO_SIDED|95.0|0.066|0.947||The p-value was derived from a statistical model adjusted for age, sex, and BMI|General linear models|||||0.947|0.066|0.0241
91740943|NCT03046927|183374543|OTHER|p values were obtained from a generalized linear model with repeated measures|Mean Difference (Net)|10.37||||0.23|TWO_SIDED|95.0|-6.4|27.13||The p-value was derived from a statistical model adjusted for age, sex, and BMI|Regression, Linear|||||27.13|-6.40|0.23
91740944|NCT03046927|183374544|OTHER||trend analysis|0.02|||<|0.001|TWO_SIDED||||||generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|||Trend analysis was obtained using generalized linear model GEE.|||<0.001
91740945|NCT01848977|183374550|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Unpaired t-test was used to compare the difference between SrO2 and StO2.||||<0.05
91740946|NCT01032954|183374553|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM= GENERAL LINEAR MODELS WITH REPEATED|||||||<0.05
91740947|NCT01032954|183374554|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM|||||||<0.05
91740948|NCT00620373|183374588|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||Significant difference p ≤ 0.05||||.016
91740949|NCT00620373|183374588|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||significant difference p ≤ 0.05||||.07
91740950|NCT00620373|183374589|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.016
91740951|NCT00620373|183374589|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.07
91499823|NCT01287897|182869648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|11.0||0.0438|TWO_SIDED|90.0|0.7|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.7|0.0438
91740952|NCT00620373|183374589|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
91740953|NCT00620373|183374589|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
91499824|NCT01287897|182869649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|13.6||0.2258|TWO_SIDED|90.0|-12.1|32.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||32.6|-12.1|0.2258
91740954|NCT00620373|183374589|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||.5
91740955|NCT00620373|183374589|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||>.99
91740956|NCT00620373|183374591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
91740957|NCT00620373|183374591|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||McNemar|||significant difference p ≤ 0.05||||.069
91740958|NCT00620373|183374592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
91740959|NCT00620373|183374592|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||McNemar|||significant difference p ≤ 0.05||||.218
91740960|NCT02975804|183374619|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91740961|NCT02975804|183374620|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91740962|NCT02975804|183374621|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91740963|NCT02975804|183374622|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91740964|NCT02975804|183374623|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91740965|NCT02975804|183374624|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91740966|NCT02975804|183374628|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91740967|NCT02975804|183374629|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91740968|NCT02956746|183374637|OTHER|||||||0.4187||||||threshold for significance p-values \< 0.05|ANOVA|||||||0.4187
91740969|NCT02630693|183374655|OTHER|As stated in the protocol, the primary objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for progression free survival.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|90.0|0.66|1.3|||||Hazard ratio of Palbociclib100mg arm vs 125 mg arm|||1.30|0.66|
91740970|NCT02630693|183374658|OTHER|As stated in the protocol, the objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for overall survival.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|90.0|0.67|1.69|||||Hazard ratio for Palbociclib 100mg arm vs 125 mg arm|||1.69|0.67|
91740971|NCT04105868|183374666|OTHER|Within-group pre/post differences were tested using a paired t-test.||||||0.004|||||||t-test, 2 sided|Two-tailed paired samples t-test comparing baseline and post-training SSVEP competition index scores||Null hypothesis: No within-subject change in SSVEP competition index from baseline to post-training.||||.004
91740972|NCT04105868|183374667|OTHER|Within-group pre/post differences were tested using a paired t-test.||||||0.25|||||||t-test, 2 sided|Two-tailed paired samples t-test comparing baseline and post-stressor VAS sadness scores.||Null hypothesis: No within-subject change in VAS Sadness scores from baseline to post-stressor.||||.25
91740973|NCT04105868|183374668|OTHER|Within-group pre/post differences were tested using a paired t-test.||||||0.471|||||||t-test, 2 sided|Two-tailed paired samples t-test comparing baseline and post-stressor VAS anxiety scores.||Null hypothesis: No within-subject change in VAS Anxiety scores from baseline to post-stressor.||||.471
91740974|NCT02661997|183374679|SUPERIORITY|||||||0.58||||||Between group differences|ANOVA|||||||0.58
91740975|NCT02661997|183374680|SUPERIORITY|||||||0.88|||||||ANOVA|||||||0.88
91740976|NCT02661997|183374681|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.17
91740977|NCT02661997|183374682|SUPERIORITY|||||||0.88|||||||ANOVA|||This is an analysis of pre to post-treatment changes on the Physical Health subscale of the PROMIS Global Health Scale||||0.88
91740978|NCT02661997|183374683|SUPERIORITY|||||||0.032||||||P-value for group by time interaction|ANOVA|||||||0.032
91740979|NCT02661997|183374684|SUPERIORITY|||||||0.44||||||P-value for group by time interaction|ANOVA|||||||0.44
91740980|NCT02661997|183374685|SUPERIORITY|||||||0.73||||||P-value for group by time interaction|ANOVA|||||||0.73
91499825|NCT01287897|182869650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|10.5||0.2627|TWO_SIDED|90.0|-10.6|23.9||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||23.9|-10.6|0.2627
91740981|NCT02661997|183374686|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
91740982|NCT02661997|183374687|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
91740983|NCT02661997|183374688|SUPERIORITY|||||||0.006||||||P-value for group by time interaction|ANOVA|||||||0.006
91740984|NCT02661997|183374689|SUPERIORITY|||||||0.55||||||P-value for group by time interaction|ANOVA|||||||0.55
91740985|NCT02661997|183374690|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
91740986|NCT02661997|183374691|SUPERIORITY|||||||0.13|||||||ANOVA|||||||0.13
91499826|NCT01287897|182869650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.8|STANDARD_ERROR_OF_MEAN|10.9||0.0425|TWO_SIDED|90.0|0.8|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.8|0.0425
91740987|NCT02661997|183374692|SUPERIORITY|||||||0.26|||||||ANOVA|||||||0.26
91499827|NCT01287897|182869651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|13.7||0.1362|TWO_SIDED|90.0|-7.5|37.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||37.6|-7.5|0.1362
91531215|NCT03354637|182939060|SUPERIORITY|||||||0.602|||||||Wilcoxon (Mann-Whitney)|||||||0.602
91740988|NCT02661997|183374693|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
91740989|NCT02661997|183374694|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
91499828|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|7.0||0.1527|TWO_SIDED|90.0|-4.3|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 2.||18.6|-4.3|0.1527
91531216|NCT03354637|182939060|SUPERIORITY|||||||0.643|||||||Wilcoxon (Mann-Whitney)|||||||0.643
91531217|NCT03354637|182939061|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||||||0.992
91740990|NCT02661997|183374697|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91740991|NCT02661997|183374698|SUPERIORITY|||||||0.91|||||||ANOVA|||||||0.91
91740992|NCT02661997|183374699|SUPERIORITY|||||||0.42|||||||ANOVA|||||||0.42
91740993|NCT02661997|183374700|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
91740994|NCT02661997|183374701|SUPERIORITY|||||||0.99|||||||ANOVA|||||||0.99
91740995|NCT02661997|183374702|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
91740996|NCT02661997|183374703|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
91740997|NCT02661997|183374704|SUPERIORITY|||||||0.09||||||An adjusted p value was used based on Levene's test.|t-test, 2 sided|||||||0.09
91740998|NCT02661997|183374705|SUPERIORITY|||||||0.75|||||||ANOVA|||||||0.75
91740999|NCT02661997|183374706|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
91741000|NCT02661997|183374707|SUPERIORITY|||||||0.67|||||||ANOVA|||||||0.67
91741001|NCT02661997|183374708|SUPERIORITY|||||||0.43|||||||ANOVA|||||||0.43
91741002|NCT02661997|183374709|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.80
91741003|NCT02661997|183374710|SUPERIORITY|||||||0.31|||||||ANOVA|||||||0.31
91741004|NCT02661997|183374711|SUPERIORITY|||||||0.16|||||||ANOVA|||||||0.16
91741005|NCT02661997|183374712|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91741006|NCT02661997|183374713|SUPERIORITY|||||||0.56|||||||ANOVA|||||||0.56
91741007|NCT02661997|183374714|SUPERIORITY|||||||0.64|||||||ANOVA|||||||0.64
91741008|NCT01057693|183374729|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32||||0.1221|TWO_SIDED|95.0|-0.74|0.09|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.||0.09|-0.74|0.1221
91741009|NCT02413996|183374759|SUPERIORITY||Mean Difference (Net)|5.94|STANDARD_DEVIATION|5.3||0.05|TWO_SIDED|95.0|-4.62|16.51|||t-test, 2 sided|||Does VRRS rehabilitation is superior to the traditional one?||16.51|-4.62|0.05
91741010|NCT00090779|183374773|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
91741011|NCT00090779|183374774|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91741012|NCT01672879|183374782|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.5||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.5|-1.2|
91741013|NCT01672879|183374782|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.4||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.4|-1.2|
91741014|NCT01672879|183374783|SUPERIORITY|||||||0.41|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.41
91531218|NCT03354637|182939061|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
91531219|NCT03354637|182939063|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
91531220|NCT03354637|182939063|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
91531221|NCT03354637|182939065|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
91531222|NCT03354637|182939065|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
91531223|NCT03354637|182939066|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
91499829|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|9.1||0.0235|TWO_SIDED|90.0|3.1|33.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 4.||33.2|3.1|0.0235
91499830|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|9.9||0.0792|TWO_SIDED|90.0|-2.3|30.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 6.||30.2|-2.3|0.0792
91499831|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|11.0||0.1909||90.0|-8.4|27.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 10.||27.6|-8.4|0.1909
91499832|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|6.8||0.1981|TWO_SIDED|90.0|-5.4|17.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 2.||17.0|-5.4|0.1981
91499833|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_ERROR_OF_MEAN|9.3||0.0132|TWO_SIDED|90.0|5.3|35.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 4.||35.8|5.3|0.0132
91499834|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|10.1||0.0063|TWO_SIDED|90.0|8.6|41.7|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 6.||41.7|8.6|0.0063
91499835|NCT01287897|182869652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|11.2||0.0138|TWO_SIDED|90.0|6.2|43.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 10.||43.1|6.2|0.0138
91741015|NCT01672879|183374783|SUPERIORITY|||||||0.065|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.065
91741016|NCT05069649|183374790|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
91499836|NCT01287897|182869653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|10.2||0.0662|TWO_SIDED|90.0|-1.4|32.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 2.||32.1|-1.4|0.0662
91499837|NCT01287897|182869653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|10.0||0.1708|TWO_SIDED|90.0|-6.9|25.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 4.||25.8|-6.9|0.1708
91499838|NCT01287897|182869653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|11.1||0.2416|TWO_SIDED|90.0|-10.5|26.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 6.||26.0|-10.5|0.2416
91499839|NCT01287897|182869653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|STANDARD_ERROR_OF_MEAN|14.1||0.088|TWO_SIDED|90.0|-4.1|42.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 10.||42.3|-4.1|0.0880
91499840|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|3.2||0.261|TWO_SIDED|90.0|-3.2|7.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 2.||7.2|-3.2|0.2610
91499841|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.4291|TWO_SIDED|90.0|-5.6|7.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 4.||7.0|-5.6|0.4291
91531224|NCT03354637|182939066|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
91499842|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|6.0||0.5791|TWO_SIDED|90.0|-11.0|8.6|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 6.||8.6|-11.0|0.5791
91499843|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|8.0||0.7544|TWO_SIDED|90.0|-18.8|7.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 8.||7.7|-18.8|0.7544
91499844|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|9.2||0.2308||90.0|-8.3|21.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 10.||21.9|-8.3|0.2308
91531225|NCT00738530|182939076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.336|TWO_SIDED|95.0|0.76|1.1|||Log Rank|||||1.10|0.76|0.3360
91531226|NCT00738530|182939078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0004|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0004
91741017|NCT05069649|183374791|SUPERIORITY|||||||0.2488|||||||Fisher Exact|||||||0.2488
91741018|NCT05069649|183374792|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91741019|NCT05069649|183374793|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||0.32
91741020|NCT05069649|183374794|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
91741021|NCT05069649|183374795|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
91499845|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|7.1||0.5038|TWO_SIDED|90.0|-11.8|11.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 12.||11.7|-11.8|0.5038
91741022|NCT03951766|183374797|SUPERIORITY||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.1||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||||-1.1|-1.9|<.0001
91741023|NCT03951766|183374798|SUPERIORITY||Median Difference (Final Values)|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.7|-17.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-17.1|-32.7|<.0001
91741024|NCT03951766|183374799|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.06|TWO_SIDED|95.0|0.0|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||PANAS positive affect||0.4|-0.0|0.06
91741025|NCT03951766|183374799|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.36|TWO_SIDED|95.0|-0.4|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||PANAS negative affect||0.1|-0.4|0.36
91741026|NCT03951766|183374800|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.1627|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1627
91741027|NCT03951766|183374801|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.62|TWO_SIDED|95.0|-3.8|6.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - past week||6.3|-3.8|0.62
91741028|NCT03951766|183374801|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.83|TWO_SIDED|95.0|-5.4|4.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - right now||4.4|-5.4|0.83
91741029|NCT03951766|183374802|SUPERIORITY||Mean Difference (Final Values)|13.1|||<|0.0001|TWO_SIDED|95.0|7.6|18.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||SEQ-12 - Internal||18.7|7.6|<.0001
91741030|NCT03951766|183374802|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.0001|TWO_SIDED|95.0|6.1|16.1|||t-test, 2 sided|||SEQ-12 - External||16.1|6.1|<.0001
91499846|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|4.9||0.0498|TWO_SIDED|90.0|0.0|16.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 2.||16.0|0.0|0.0498
91499847|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|7.6||0.0155|TWO_SIDED|90.0|3.9|28.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 4.||28.7|3.9|0.0155
91531227|NCT00738530|182939079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||||0.86|0.62|0.0002
91741031|NCT03951766|183374803|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.0126|TWO_SIDED|95.0|1.2|9.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||9.8|1.2|0.0126
91741032|NCT03951766|183374804|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.0053|TWO_SIDED|95.0|-11.1|-2.0||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.0|-11.1|0.0053
91741033|NCT03951766|183374805|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||ATS - Adverse Effects||0.2|-0.1|0.76
91741034|NCT03951766|183374805|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Psychoactive Benefits||-0.5|-1.0|<.0001
91741035|NCT03951766|183374805|SUPERIORITY||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Pleasure||-0.3|-0.8|<.0001
91741036|NCT03951766|183374806|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.25|TWO_SIDED|95.0|-0.3|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.1|-0.3|0.25
91741037|NCT03951766|183374807|SUPERIORITY|DBI - Positive Experiences|Mean Difference (Final Values)|-20.7|||<|0.0001|TWO_SIDED|95.0|-27.2|-14.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-14.3|-27.2|<.0001
91741038|NCT03951766|183374807|SUPERIORITY|DBI - Negative Experiences|Mean Difference (Final Values)|-2.9||||0.27|TWO_SIDED|95.0|-8.1|2.3||"We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6."|t-test, 2 sided|||||2.3|-8.1|0.27
91499848|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.5||0.0399|TWO_SIDED|90.0|0.9|28.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 6.||28.9|0.9|0.0399
91499849|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|9.6||0.1866|TWO_SIDED|90.0|-7.2|24.3|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 8.||24.3|-7.2|0.1866
91499850|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|10.3||0.0415|TWO_SIDED|90.0|0.9|34.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 10.||34.7|0.9|0.0415
91741039|NCT03951766|183374808|SUPERIORITY|Pros of Being Smoke-Free|Mean Difference (Final Values)|-9.1||||0.009|TWO_SIDED|95.0|-15.9|-2.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.3|-15.9|0.009
91741040|NCT03951766|183374808|SUPERIORITY|Cons of Quitting|Mean Difference (Final Values)|-5.1||||0.25|TWO_SIDED|95.0|-13.7|3.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||3.6|-13.7|0.25
91741041|NCT03951766|183374809|SUPERIORITY|PSS total scores|Mean Difference (Final Values)|-2.4||||0.0069|TWO_SIDED|95.0|-4.1|-0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.7|-4.1|0.0069
91741042|NCT03951766|183374809|SUPERIORITY|PSS - Perceived Helplessness|Mean Difference (Final Values)|-0.3||||0.0043|TWO_SIDED|95.0|-0.5|-0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.1|-0.5|0.0043
91741043|NCT03951766|183374809|SUPERIORITY|PSS - Perceived Self-Efficacy|Mean Difference (Final Values)|0.1||||0.1953|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1953
91741044|NCT03951766|183374810|SUPERIORITY|Brief COPE Self-distraction|Mean Difference (Final Values)|0.4||||0.087|TWO_SIDED|95.0|-0.1|0.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.8|-0.1|0.087
91499851|NCT01287897|182869654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|9.5||0.0408|TWO_SIDED|90.0|0.9|32.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 12.||32.1|0.9|0.0408
91499852|NCT01287897|182869655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|5.3||0.1342|TWO_SIDED|90.0|-2.8|14.5|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 2.||14.5|-2.8|0.1342
91499853|NCT01287897|182869655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.3||0.2623|TWO_SIDED|90.0|-4.3|9.8|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 4.||9.8|-4.3|0.2623
91499854|NCT01287897|182869655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|6.3||0.3324|TWO_SIDED|90.0|-7.7|13.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 6.||13.2|-7.7|0.3324
91499855|NCT01287897|182869655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|7.5||0.6637|TWO_SIDED|90.0|-15.5|9.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 8.||9.1|-15.5|0.6637
91499856|NCT01287897|182869655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|9.0||0.2721||90.0|-9.3|20.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 10.||20.2|-9.3|0.2721
91741045|NCT03951766|183374810|SUPERIORITY|Brief COPE active coping|Mean Difference (Final Values)|-0.209||||0.2866|TWO_SIDED|95.0|-0.6|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.6|0.2866
91741046|NCT03951766|183374810|SUPERIORITY|Brief COPE denial|Mean Difference (Final Values)|0.0||||0.9296|TWO_SIDED|95.0|-0.4|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.4|-0.4|0.9296
91741047|NCT03951766|183374810|SUPERIORITY|Brief COPE substance use|Mean Difference (Final Values)|-0.1||||0.6599|TWO_SIDED|95.0|-0.5|0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.3|-0.5|0.6599
91741048|NCT03951766|183374810|SUPERIORITY|Brief COPE use of emotional support|Mean Difference (Final Values)|0.3||||0.2315|TWO_SIDED|95.0|-0.2|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.7|-0.2|0.2315
91499857|NCT01287897|182869655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.8||0.3022|TWO_SIDED|90.0|-8.8|16.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 12.||16.9|-8.8|0.3022
91741049|NCT03951766|183374810|SUPERIORITY|Brief COPE use of instrumental support|Mean Difference (Final Values)|0.1||||0.6183|TWO_SIDED|95.0|-0.3|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.3|0.6183
91741050|NCT03951766|183374810|SUPERIORITY|Brief COPE behavioral disengagement|Mean Difference (Final Values)|0.3||||0.2037|TWO_SIDED|95.0|-0.1|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.7|-0.1|0.2037
91741051|NCT03951766|183374810|SUPERIORITY|Brief COPE venting|Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-0.9|0.0060
91741052|NCT03951766|183374810|SUPERIORITY|Brief COPE positive reframing|Mean Difference (Final Values)|-0.2||||0.3045|TWO_SIDED|95.0|-0.7|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.7|0.3045
91741053|NCT03951766|183374810|SUPERIORITY|Brief COPE planning|Mean Difference (Final Values)|-0.6||||0.0029|TWO_SIDED|95.0|-1.0|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-1.0|0.0029
91741054|NCT03951766|183374810|SUPERIORITY|Brief COPE humor|Mean Difference (Final Values)|0.0||||0.8274|TWO_SIDED|95.0|-0.5|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.5|0.8274
91741055|NCT03951766|183374810|SUPERIORITY|Brief COPE acceptance|Mean Difference (Final Values)|0.4||||0.0349|TWO_SIDED|95.0|0.0|0.9||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.9|0.0|0.0349
91499858|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|7.0||0.2687|TWO_SIDED|90.0|-7.2|15.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 2.||15.8|-7.2|0.2687
91499859|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|7.4||0.246|TWO_SIDED|90.0|-7.1|17.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 4.||17.3|-7.1|0.2460
91531228|NCT00738530|182939081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0023|TWO_SIDED|95.0|0.66|0.92|||Log Rank|||||0.92|0.66|0.0023
91531229|NCT00738530|182939082|SUPERIORITY_OR_OTHER||Difference in response rates|19.9|||<|0.0001|TWO_SIDED|95.0|13.2|26.6|||Chi-squared|||||26.6|13.2|<.0001
91741056|NCT03951766|183374810|SUPERIORITY|Brief COPE religion|Mean Difference (Final Values)|0.2||||0.3451|TWO_SIDED|95.0|-0.2|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.2|0.3451
91741057|NCT03951766|183374810|SUPERIORITY|Brief COPE self-blame|Mean Difference (Final Values)|-0.8||||0.0006|TWO_SIDED|95.0|-1.2|-0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.3|-1.2|0.0006
91741058|NCT02623972|183374816|OTHER||Pathelogic Complete Response Rate|30.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 10% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 30% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.10, Alternative hypothesis that proportion pCR ≥ 0.30. Hypothesized False Positive Rate(α)=10%; Hypothesized False Negative Rate(1-β)=10%.||||
91741059|NCT02623972|183374816|OTHER||Pathelogic Complete Response Rate|23.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 2% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 23% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.02, Alternative hypothesis that proportion pCR ≥ 0.23. Hypothesized False Positive Rate(α)=5%; Hypothesized False Negative Rate(1-β)=10%.||||
91741060|NCT04847843|183374825|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<0.001
91741061|NCT04847843|183374826|SUPERIORITY|||||||0.22|||||||Regression, Linear|||||||0.22
91741062|NCT04847843|183374827|SUPERIORITY|||||||0.62|||||||Regression, Linear|||||||0.62
91741063|NCT04847843|183374829|SUPERIORITY|||||||0.21|||||||Regression, Linear|||||||0.21
91741064|NCT04847843|183374830|SUPERIORITY|||||||0.11|||||||Regression, Linear|||||||0.11
91741065|NCT01061385|183374856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.2922|TWO_SIDED|95.0|-6.8|21.7|||t-test, 1 sided|||||21.7|-6.8|0.2922
91741066|NCT01061385|183374857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|||||TWO_SIDED|95.0|-37.7|38.0|||||The 95% CI range above is calculated for the current estimated value.|||38.0|-37.7|
91741067|NCT03800030|183374858|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.305||||||0.031
91741068|NCT03800030|183374859|SUPERIORITY|||||||0.935|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 0.083||||||0.935
91741069|NCT03800030|183374860|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 1.833||||||0.040
91741070|NCT03800030|183374861|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 2.174||||||0.020
91741071|NCT03800030|183374862|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = -0.623||||||0.540
91741072|NCT03800030|183374863|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.989||||||0.007
91741073|NCT02379052|183374878|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7||||0.0304|TWO_SIDED|95.0|-3.22|-0.16|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.16|-3.22|0.0304
91499860|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_ERROR_OF_MEAN|9.3||0.0633|TWO_SIDED|90.0|-1.1|29.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 6.||29.5|-1.1|0.0633
91741074|NCT02379052|183374879|SUPERIORITY||Least Squares Mean Difference|-26.45||||0.0312|TWO_SIDED|95.0|-50.523|-2.387|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-2.387|-50.523|0.0312
91741075|NCT02379052|183374880|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.383|TWO_SIDED|95.0|-2.48|0.96|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.96|-2.48|0.3830
91531230|NCT01656759|182939085|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||||||0.2
91499861|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|9.9||0.4036|TWO_SIDED|90.0|-13.8|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 8.||18.6|-13.8|0.4036
91531231|NCT01656759|182939086|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
91531232|NCT01656759|182939088|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
91741076|NCT02379052|183374881|SUPERIORITY||Least Squares Mean Difference|-11.0||||0.4147|TWO_SIDED|95.0|-37.46|15.467|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||15.467|-37.460|0.4147
91741077|NCT02379052|183374882|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
91741078|NCT02379052|183374883|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
91741079|NCT02379052|183374884|SUPERIORITY||Least Squares Mean Difference|-23.23||||0.085|TWO_SIDED|95.0|-49.677|3.212|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||3.212|-49.677|0.0850
91741080|NCT02379052|183374885|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0635|TWO_SIDED|95.0|-28.54|0.78|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.78|-28.54|0.0635
91741081|NCT02379052|183374886|SUPERIORITY||Least Squares Mean Difference|-33.65||||0.0608|TWO_SIDED|95.0|-68.828|1.536|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||1.536|-68.828|0.0608
91499862|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|10.2||0.1921||90.0|-7.9|25.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 10.||25.6|-7.9|0.1921
91741082|NCT02379052|183374887|SUPERIORITY||Least Squares Mean Difference|-21.1||||0.0318|TWO_SIDED|95.0|-40.42|-1.86|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-1.86|-40.42|0.0318
91741083|NCT02379052|183374888|SUPERIORITY||Percent Difference|17.8||||0.1365|TWO_SIDED|95.0|-11.54|43.55||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||43.55|-11.54|0.1365
91741084|NCT02379052|183374889|SUPERIORITY||Percent Difference|35.0||||0.0044|TWO_SIDED|95.0|5.69|58.34||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||58.34|5.69|0.0044
91741085|NCT02379052|183374890|SUPERIORITY||Least Squares Mean Difference|-107.13|||<|0.0001|TWO_SIDED|95.0|-141.215|-73.046|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-73.046|-141.215|<0.0001
91741086|NCT02379052|183374891|SUPERIORITY||Least Square Mean Difference|-1.6||||0.0006|TWO_SIDED|95.0|-2.5|-0.68|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-0.68|-2.50|0.0006
91741087|NCT02379052|183374892|SUPERIORITY||Least Squares Mean Difference|0.33||||0.091|TWO_SIDED|95.0|-0.053|0.72|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.720|-0.053|0.0910
91741088|NCT04229888|183374936|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in DEQ-5 score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.02|||||||ANOVA|||||||0.02
91499863|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|10.3||0.1541|TWO_SIDED|90.0|-6.5|27.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 12.||27.5|-6.5|0.1541
91741089|NCT04229888|183374937|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in MG score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M= 1 representing the largest clinically acceptable difference based on historical data.||||||0.07|||||||ANOVA|||||||0.07
91741090|NCT04229888|183374938|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in TBUT, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.66|||||||ANOVA|||||||0.66
91741091|NCT01282866|183374939|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91499864|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|6.5||0.4893|TWO_SIDED|90.0|-10.5|10.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 2.||10.9|-10.5|0.4893
91499865|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|8.6||0.0619|TWO_SIDED|90.0|-0.9|27.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 4.||27.4|-0.9|0.0619
91741092|NCT02948582|183374958|SUPERIORITY||least squares mean|0.033||||0.1257|TWO_SIDED|95.0|-0.009|0.075|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.075|-0.009|0.1257
91741093|NCT02948582|183374958|SUPERIORITY||least squares mean|0.072||||0.0008|TWO_SIDED|95.0|0.03|0.113|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.113|0.030|0.0008
91741094|NCT02948582|183374958|SUPERIORITY||least squares mean|0.102|||<|0.0001|TWO_SIDED|95.0|0.061|0.144|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.144|0.061|<0.0001
91741095|NCT02948582|183374958|SUPERIORITY||least squares mean|0.108|||<|0.0001|TWO_SIDED|95.0|0.066|0.15|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.150|0.066|<0.0001
91741096|NCT02948582|183374958|SUPERIORITY||least squares mean|0.098|||<|0.0001|TWO_SIDED|95.0|0.056|0.14|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.140|0.056|<0.0001
91741097|NCT02948582|183374959|SUPERIORITY||least squares mean|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.123|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.123|0.050|<0.0001
91741098|NCT02948582|183374959|SUPERIORITY||least squares mean|0.151|||<|0.0001|TWO_SIDED|95.0|0.114|0.187|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.187|0.114|<0.0001
91741099|NCT02948582|183374959|SUPERIORITY||least squares mean|0.156|||<|0.0001|TWO_SIDED|95.0|0.12|0.193|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.193|0.120|<0.0001
91741100|NCT02948582|183374959|SUPERIORITY||least squares mean|0.202|||<|0.0001|TWO_SIDED|95.0|0.165|0.239|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.239|0.165|<0.0001
91741101|NCT02948582|183374959|SUPERIORITY||least squares mean|0.199|||<|0.0001|TWO_SIDED|95.0|0.162|0.235|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.235|0.162|<0.0001
91499866|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7|STANDARD_ERROR_OF_MEAN|9.3||0.029|TWO_SIDED|90.0|2.3|33.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 6.||33.1|2.3|0.0290
91741102|NCT02948582|183374960|SUPERIORITY||least squares mean|0.058||||0.0028|TWO_SIDED|95.0|0.021|0.095|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.095|0.021|0.0028
91741103|NCT02948582|183374960|SUPERIORITY||least squares mean|0.1|||<|0.0001|TWO_SIDED|95.0|0.063|0.137|||least squares mena|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.137|0.063|<0.0001
91741104|NCT02948582|183374960|SUPERIORITY||least squares mean|0.105|||<|0.0001|TWO_SIDED|95.0|0.068|0.142|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.142|0.068|<0.0001
91741105|NCT02948582|183374960|SUPERIORITY||least squares mean|0.135|||<|0.0001|TWO_SIDED|95.0|0.098|0.173|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.173|0.098|<0.0001
91741106|NCT02948582|183374960|SUPERIORITY||least squares mean|0.128|||<|0.0001|TWO_SIDED|95.0|0.091|0.166|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.166|0.091|<0.0001
91741107|NCT03810014|183374982|SUPERIORITY||Risk Difference (RD)|2.5||||0.01|TWO_SIDED|98.0|0.2|4.8|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||4.80|0.20|0.01
91499867|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|10.7||0.0988|TWO_SIDED|90.0|-3.8|31.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 8.||31.4|-3.8|0.0988
91499868|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2|STANDARD_ERROR_OF_MEAN|10.8||0.0549|TWO_SIDED|90.0|-0.5|35.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 10.||35.0|-0.5|0.0549
91741108|NCT03810014|183374982|SUPERIORITY||Risk Ratio, log|1.025||||0.012|TWO_SIDED|98.0|1.002|1.049|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||1.049|1.002|0.012
91741109|NCT03810014|183374982|SUPERIORITY||Risk Difference (RD)|-0.6||||0.33|TWO_SIDED|98.0|-2.2|0.9|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||0.90|-2.20|0.33
91741110|NCT03810014|183374982|SUPERIORITY||Risk Ratio, log|0.994||||0.332|TWO_SIDED|98.0|0.979|1.009|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||1.009|0.979|0.332
91741111|NCT01102491|183375059|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91741112|NCT02292537|183375063|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.91||1e-07|TWO_SIDED|95.0|3.1|6.7|||ANCOVA|ANCOVA model with treatment group as a factor and age at Screening and baseline HFMSE score as covariates.||||6.7|3.1|0.0000001
91741113|NCT02292537|183375064|SUPERIORITY||Odds Ratio (OR)|5.59||||0.0006|TWO_SIDED|95.0|2.09|14.91||Based on multiple imputation and logistic regression with treatment effect and adjustment for each participant's age at screening and HFMSE score at baseline.|Regression, Logistic|||||14.91|2.09|0.0006
91741114|NCT02292537|183375064|SUPERIORITY||Difference in Proportions|30.5|||||TWO_SIDED|95.0|12.74|48.31|||||Difference in proportions of Nusinersen minus Sham Procedure are from multiple imputation procedure and are based on binomial proportions.|||48.31|12.74|
91741115|NCT02292537|183375065|SUPERIORITY||Difference in Proportions|13.8||||0.0811|TWO_SIDED|95.0|-6.64|34.17|||Fisher Exact||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||34.17|-6.64|0.0811
91741116|NCT02292537|183375066|SUPERIORITY||LS Mean Difference|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and number of milestones at baseline.|||0.7|0.2|
91741117|NCT02292537|183375067|SUPERIORITY||LS Mean Differenec|3.7|||||TWO_SIDED|95.0|2.3|5.0|||||From multiple imputation procedure, based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and derived total score at baseline.|||5.0|2.3|
91741118|NCT02292537|183375068|SUPERIORITY||Difference in Proportions|-1.4|||||TWO_SIDED|95.0|-21.84|19.34|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||19.34|-21.84|
91741119|NCT02292537|183375069|SUPERIORITY||Difference in Proportions|1.5|||||TWO_SIDED|95.0|-19.1|22.1|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||22.10|-19.10|
91741120|NCT01444430|183375078|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).|Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.698|1.65|||Regression, Cox|||||1.650|0.698|
91741121|NCT01444430|183375079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.835||||0.002|TWO_SIDED|95.0|0.745|0.937|||Regression, Cox|||||0.937|0.745|0.002
91741122|NCT01444430|183375080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|3.3|5.4|||ANOVA|||||5.4|3.3|<0.001
91741123|NCT01444430|183375081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.272|TWO_SIDED|95.0|-0.5|1.7|||ANOVA|||||1.7|-0.5|0.272
91741124|NCT01444430|183375082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||ANOVA|||||-0.1|-0.2|<0.001
91741125|NCT01444430|183375083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06|||ANCOVA|||||-0.06|-0.10|<0.001
91741126|NCT01444430|183375084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-1.0|-0.2|||ANOVA|||||-0.2|-1.0|0.004
91741127|NCT01444430|183375085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.095|TWO_SIDED|95.0|0.518|1.055|||Regression, Cox|||||1.055|0.518|0.095
91741128|NCT01142388|183375090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on: 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.85
91741129|NCT01142388|183375091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.50
91741130|NCT00802997|183375093|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
91741131|NCT05265728|183375138|SUPERIORITY||Least Square Mean (LS mean)|0.37|||||TWO_SIDED|95.0|0.18|0.76|||||LS mean (95% Confidence Interval \[CI\]) lesions were obtained from a Poisson distribution model with no explanatory variables.|||0.76|0.18|
91499869|NCT01287897|182869656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|10.5||0.092|TWO_SIDED|90.0|-3.3|31.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 12.||31.3|-3.3|0.0920
91499870|NCT01287897|182869657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|6.8||0.4031|TWO_SIDED|90.0|-9.5|12.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 2.||12.9|-9.5|0.4031
91499871|NCT01287897|182869657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|9.6||0.1219|TWO_SIDED|90.0|-4.6|26.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 4.||26.8|-4.6|0.1219
91499872|NCT01287897|182869657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|10.0||0.16|TWO_SIDED|90.0|-6.5|26.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 6.||26.4|-6.5|0.1600
91531233|NCT04179461|182939091|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the CASI was captured at clinical visits. 3. A level of statistical significance was established at \< 0.05.||||||0.52||||||Change in CASI score from V1 to V3|Wilcoxon (Mann-Whitney)|||The modified CASI score incorporates key asthma outcomes such as symptoms, healthcare utilization, and medication dose.||||0.52
91531234|NCT04179461|182939092|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.45||||||The change in ACT score from V1 to V2 (the period between V1 and V2).|Wilcoxon (Mann-Whitney)|||||||0.45
91499873|NCT01287897|182869657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.3||0.6019|TWO_SIDED|90.0|-19.5|14.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 8.||14.2|-19.5|0.6019
91531235|NCT04179461|182939092|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.01||||||The change in ACT score from V1-V2 to V2-V3.|Wilcoxon (Mann-Whitney)|||||||0.01
91741132|NCT05265728|183375139|SUPERIORITY||Least Square Mean|3.08|||||TWO_SIDED|95.0|0.69|13.74|||||LS mean (95% CI) lesions were obtained from a Poisson distribution model with no explanatory variables.|||13.74|0.69|
91741133|NCT01693250|183375169|SUPERIORITY||Mean Difference (Final Values)|1.68|STANDARD_DEVIATION|0.5|<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.||||<.001
91499874|NCT01287897|182869657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|12.3||0.1601||90.0|-8.0|32.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 10.||32.5|-8.0|0.1601
91499875|NCT01287897|182869657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|11.7||0.2622|TWO_SIDED|90.0|-11.8|26.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 12.||26.6|-11.8|0.2622
91499876|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|12.22||0.2173|TWO_SIDED|90.0|-29.8|10.6|||Linear mixed model (LMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 2.||10.6|-29.8|0.2173
91499877|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|12.95||0.1778|TWO_SIDED|90.0|-33.4|9.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 4.||9.4|-33.4|0.1778
91741134|NCT01693250|183375170|SUPERIORITY||Mean Difference (Final Values)|2.66||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.||||.001
91760115|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.62|0.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-0.62|
91760116|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.18|1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.09|0.18|
91760117|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.21|0.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.21|
91741135|NCT00600106|183375175|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.36|||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.36
91741136|NCT00600106|183375176|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.93
91741137|NCT00600106|183375177|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.77|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.77
91741138|NCT00600106|183375179|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.38|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.38
91741139|NCT00600106|183375183|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated. All tests were two-sided with p values \<0.05."||||0.17
91741140|NCT00600106|183375184|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.49
91741141|NCT00600106|183375185|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.77
91741142|NCT00600106|183375186|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.40
91741143|NCT00600106|183375187|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.99
91741144|NCT00600106|183375188|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.21
91741145|NCT03783962|183375194|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
91741146|NCT03783962|183375195|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||||||.97
91741147|NCT03783962|183375196|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
91741148|NCT03783962|183375196|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741149|NCT03783962|183375196|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741150|NCT03783962|183375197|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||.18
91741151|NCT03783962|183375197|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
91741152|NCT03783962|183375197|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
91741153|NCT03783962|183375198|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
91741154|NCT03783962|183375198|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741155|NCT03783962|183375198|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741156|NCT03783962|183375199|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
91741157|NCT03783962|183375199|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741158|NCT03783962|183375199|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741159|NCT03783962|183375200|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||.26
91741160|NCT03783962|183375200|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|||||||.41
91741161|NCT03783962|183375200|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
91741162|NCT03783962|183375201|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||.03
91741163|NCT03783962|183375201|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
91741164|NCT03783962|183375201|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91741165|NCT03783962|183375202|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||.58
91741166|NCT03783962|183375202|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
91741167|NCT03783962|183375202|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
91741168|NCT03783962|183375203|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
91741169|NCT03783962|183375204|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91741170|NCT01169337|183375209|SUPERIORITY|||||||0.0005|||||||Log Rank|stratified 1-sided log-rank test||||||0.0005
91741171|NCT03726658|183375227|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.24||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.98
91759515|NCT02391363|183411766|SUPERIORITY|||||||0.89||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.89
91760118|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.5|0.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.50|
91741172|NCT03726658|183375227|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.25||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.25
91741173|NCT03726658|183375227|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|2.26||0.93|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||||0.93
91741174|NCT03726658|183375228|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group|Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.02||0.43|TWO_SIDED|||||a priori threshold for statistical significance was \<0.05|Mixed Models Analysis|||Chane from baseline in treated group compared to change from baseline in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
91741175|NCT03726658|183375228|EQUIVALENCE|Change from baseline in treated group compared to change in baseline in placebo group|Median Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.02||0.84|TWO_SIDED|||||The a priori threshold for statistical significance was P \<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.84
91741176|NCT03726658|183375229|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 9|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.69|TWO_SIDED|||||A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.69
91741177|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
91499878|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|16.37||0.1661|TWO_SIDED|90.0|-43.0|11.2|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 6.||11.2|-43.0|0.1661
91741178|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.43|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
91741179|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.55|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculaton was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.55
91741180|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15.|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
91741181|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.69||0.56|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.56
91741182|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.74||0.8|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.80
91741183|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Median Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.74||0.45|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.45
91741184|NCT03726658|183375229|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|2.77||0.67|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.67
91741185|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.36||0.43|TWO_SIDED|||||a priori threshold for statistical significance was p\>0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
91741186|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.38||0.59|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.59
91741187|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|2.44||0.35|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14, Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.35
91499879|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|17.66||0.1993|TWO_SIDED|90.0|-44.1|14.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 8.||14.3|-44.1|0.1993
91741188|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.82|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.82
91741189|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.62||0.61|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.61
91741190|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.69||0.47|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.47
91760119|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.43|0.48||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.48|-0.43|
91760120|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|0.26|1.26||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.26|0.26|
91760121|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-0.29|0.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.29|
91760122|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.55|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.55|
91741191|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.48||0.76|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.76
91741192|NCT03726658|183375230|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.99
91741193|NCT05710640|183375231|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 50 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||||||1.000
91741194|NCT05710640|183375232|SUPERIORITY|||||||0.294||||||P-value is from comparing the proportion of JIA ACR 50 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 4||||0.294
91741195|NCT05710640|183375232|SUPERIORITY|||||||0.637||||||P-value is from comparing the proportion of JIA ACR 50 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 12||||0.637
91741196|NCT05710640|183375232|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 50 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 16||||1.00
91741197|NCT05710640|183375233|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 30 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 4||||1.000
91499880|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|19.66||0.0632|TWO_SIDED|90.0|-62.7|2.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 10.||2.3|-62.7|0.0632
91741198|NCT05710640|183375233|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 30 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 8||||1.000
91741199|NCT05710640|183375233|SUPERIORITY|||||||0.62||||||P-value is from comparing the proportion of JIA ACR 30 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 12||||0.620
91741200|NCT05710640|183375233|SUPERIORITY|||||||0.576||||||P-value is from comparing the proportion of JIA ACR 30 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 16||||0.576
91741201|NCT05710640|183375234|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 70 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 4||||1.000
91741202|NCT05710640|183375234|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 70 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 8||||1.00
91741203|NCT05710640|183375234|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 70 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 12||||1.000
91741204|NCT05710640|183375234|SUPERIORITY|||||||0.637||||||P-value is from comparing the proportion of JIA ACR 70 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 16||||0.637
91741205|NCT05710640|183375235|SUPERIORITY|||||||0.331||||||P-value comes from an analysis of covariance with an outcome of change in JADAS-27 from Baseline and covariates of treatment and Baseline JADAS-27 score.|ANCOVA|||Week 4||||0.331
91741206|NCT05710640|183375235|SUPERIORITY|||||||0.5||||||P-value comes from an analysis of covariance with an outcome of change in JADAS-27 from Baseline and covariates of treatment and Baseline JADAS-27 score.|ANCOVA|||Week 8||||0.500
91741207|NCT05710640|183375235|SUPERIORITY|||||||0.285||||||P-value comes from an analysis of covariance with an outcome of change in JADAS-27 from Baseline and covariates of treatment and Baseline JADAS-27 score.|ANCOVA|||Week 12||||0.285
91741208|NCT05710640|183375235|SUPERIORITY|||||||0.148||||||P-value comes from an analysis of covariance with an outcome of change in JADAS-27 from Baseline and covariates of treatment and Baseline JADAS-27 score.|ANCOVA|||Week 16||||0.148
91741209|NCT05710640|183375236|SUPERIORITY|||||||0.294||||||P-value is from comparing the proportion of JIA ACR 50 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 12||||0.294
91741210|NCT05710640|183375236|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 50 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 16||||1.000
91741211|NCT05710640|183375237|SUPERIORITY|||||||0.335||||||P-value is from comparing the proportion of JIA ACR 30 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 12||||0.335
91741212|NCT05710640|183375237|SUPERIORITY|P-value is from comparing the proportion of JIA ACR 30 Responders between the two device groups using a Fisher's exact test.||||||1|||||||Fisher Exact|||Week 16||||1.000
91741213|NCT05710640|183375238|SUPERIORITY|||||||1||||||P-value is from comparing the proportion of JIA ACR 70 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 12||||1.000
91741214|NCT05710640|183375238|SUPERIORITY|||||||0.471||||||P-value is from comparing the proportion of JIA ACR 70 Responders between the two device groups using a Fisher's exact test.|Fisher Exact|||Week 16||||0.471
91741215|NCT05710640|183375239|SUPERIORITY|||||||0.592||||||P-value comes from an analysis of covariance with an outcome of change in JADAS-27 from Week 8 and covariates of treatment and Week 8 JADAS-27 score.|ANCOVA|||Week 12||||0.592
91741216|NCT05710640|183375239|SUPERIORITY|||||||0.337||||||P-value comes from an analysis of covariance with an outcome of change in JADAS-27 from Week 8 and covariates of treatment and Week 8 JADAS-27 score.|ANCOVA|||Week 16||||0.337
91741217|NCT00703963|183375288|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.20
91741218|NCT00703963|183375289|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.05
91741219|NCT00703963|183375290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||<0.001
91741220|NCT03994211|183375291|OTHER||Geometric Mean Ratio Estimate|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||||1.06|0.83|
91741221|NCT03994211|183375292|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.95|1.15||||||||1.15|0.95|
91741222|NCT03994211|183375293|OTHER||Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.54|0.7||||||||0.70|0.54|
91741223|NCT03994211|183375294|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.09||||||||1.09|0.91|
91741224|NCT03994211|183375295|OTHER||Geometric Mean Ratio|0.57|||||TWO_SIDED|90.0|0.48|0.69||||||||0.69|0.48|
91741225|NCT03994211|183375296|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.9|1.09||||||||1.09|0.90|
91741226|NCT01107964|183375311|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
91741227|NCT01107964|183375312|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91741228|NCT01107964|183375313|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91741229|NCT01107964|183375314|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91741230|NCT02148263|183375349|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
91741231|NCT02148263|183375350|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91741232|NCT02148263|183375351|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||.94
91741233|NCT02148263|183375352|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||.96
91741234|NCT02148263|183375353|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
91741235|NCT02148263|183375354|SUPERIORITY|This is for the upper eyelid evaluation.||||||0.27|||||||Fisher Exact|||||||.27
91741236|NCT02148263|183375354|SUPERIORITY|||||||0.58|||||||Fisher Exact|||This is for the lower eyelid evaluation.||||.58
91741237|NCT02148263|183375355|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Extent||||.50
91741238|NCT02148263|183375355|SUPERIORITY|||||||0.76|||||||Fisher Exact|||Type||||.76
91741239|NCT02148263|183375355|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Depth||||.50
91741240|NCT02148263|183375356|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91741241|NCT02148263|183375357|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91741242|NCT00906178|183375363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.57|1.94||||||||1.94|.57|
91741243|NCT00906178|183375364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.62|1.65||||||||1.65|.62|
91741244|NCT00906178|183375365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.93|2.62||||||||2.62|.93|
91741245|NCT00906178|183375366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.37|1.3||||||||1.30|.37|
91741246|NCT01272037|183375375|OTHER||Hazard Ratio (HR)|1.02||||0.35|TWO_SIDED|95.0|0.98|1.05|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.||This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.||1.05|0.98|0.35
91741247|NCT01272037|183375375|OTHER||Hazard Ratio (HR)|1.71||||0.008|TWO_SIDED|95.0|1.15|2.54|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.||This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.||2.54|1.15|0.008
91741248|NCT01272037|183375375|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.002|TWO_SIDED|95.0|0.43|0.83|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only premenopausal participants.||0.83|0.43|0.002
91741249|NCT01272037|183375375|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.89|TWO_SIDED|95.0|0.82|1.26|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.26|0.82|0.89
91741250|NCT01272037|183375382|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.009|TWO_SIDED|95.0|0.39|0.87|||Regression, Cox|||This analysis includes only premenopausal participants.|To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|0.87|0.39|0.009
91741251|NCT01272037|183375382|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.81|1.37|||Regression, Cox||To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.37|0.81|0.70
91741252|NCT01393899|183375383|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||||14.99|-12.11|
91741253|NCT01393899|183375383|SUPERIORITY_OR_OTHER||Difference in Percentage|17.72|||||TWO_SIDED|80.0|4.07|31.37||||||||31.37|4.07|
91741254|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|0.61|||||TWO_SIDED|80.0|-11.57|12.79||||||Week 4||12.79|-11.57|
91741255|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|0.78|||||TWO_SIDED|80.0|-12.29|13.84||||||Week 8||13.84|-12.29|
91741256|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
91741257|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.94|||||TWO_SIDED|80.0|-14.56|12.68||||||Week 20||12.68|-14.56|
91741258|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|5.26|||||TWO_SIDED|80.0|-6.52|17.04||||||Week 4||17.04|-6.52|
91741259|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
91741260|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|3.49|||||TWO_SIDED|80.0|-10.4|17.37||||||Week 12||17.37|-10.40|
91741261|NCT01393899|183375384|SUPERIORITY_OR_OTHER||Difference in Percentage|10.69|||||TWO_SIDED|80.0|-3.08|24.46||||||Week 20||24.46|-3.08|
91741262|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.72|||||TWO_SIDED|80.0|-14.06|10.63||||||Week 4||10.63|-14.06|
91741263|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.88|||||TWO_SIDED|80.0|-17.15|9.4||||||Week 8||9.40|-17.15|
91741264|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
91741265|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||Week 20||14.99|-12.11|
91741266|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|1.5|||||TWO_SIDED|80.0|-11.88|14.87||||||Week 26||14.87|-11.88|
91741267|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|2.93|||||TWO_SIDED|80.0|-9.06|14.92||||||Week 4||14.92|-9.06|
91741268|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
91741269|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|1.16|||||TWO_SIDED|80.0|-12.74|15.06||||||Week 12||15.06|-12.74|
91741270|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|13.07|||||TWO_SIDED|80.0|-0.63|26.77||||||Week 20||26.77|-0.63|
91741271|NCT01393899|183375385|SUPERIORITY_OR_OTHER||Difference in Percentage|20.1|||||TWO_SIDED|80.0|6.54|33.66||||||Week 26||33.66|6.54|
91741272|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|3.43|||||TWO_SIDED|80.0|-10.41|17.28||||||Week 4||17.28|-10.41|
91741273|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|1.22|||||TWO_SIDED|80.0|-12.67|15.11||||||Week 8||15.11|-12.67|
91499881|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|19.71||0.1975|TWO_SIDED|90.0|-49.4|15.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 12.||15.8|-49.4|0.1975
91499882|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|12.25||0.5868|TWO_SIDED|90.0|-17.6|22.9|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 2.||22.9|-17.6|0.5868
91499883|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|12.93||0.0243|TWO_SIDED|90.0|-47.0|-4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 4.||-4.3|-47.0|0.0243
91499884|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|STANDARD_ERROR_OF_MEAN|16.12||0.0834|TWO_SIDED|90.0|-49.0|4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 6.||4.3|-49.0|0.0834
91741274|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|13.18|||||TWO_SIDED|80.0|-0.31|26.67||||||Week 12||26.67|-0.31|
91741275|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-11.33|14.55||||||Week 20||14.55|-11.33|
91741276|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|8.64|||||TWO_SIDED|80.0|-4.36|21.64||||||Week 26||21.64|-4.36|
91741277|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|5.76|||||TWO_SIDED|80.0|-8.04|19.56||||||Week 4||19.56|-8.04|
91499885|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.8|STANDARD_ERROR_OF_MEAN|17.43||0.0499|TWO_SIDED|90.0|-57.7|0.0|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 8.||-0.0|-57.7|0.0499
91499886|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.9|STANDARD_ERROR_OF_MEAN|19.45||0.0111|TWO_SIDED|90.0|-77.1|-12.7|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 10.||-12.7|-77.1|0.0111
91741278|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.08|||||TWO_SIDED|80.0|-21.83|5.66||||||Week 8||5.66|-21.83|
91741279|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|1.55|||||TWO_SIDED|80.0|-11.63|14.73||||||Week 12||14.73|-11.63|
91499887|NCT01287897|182869658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.5|STANDARD_ERROR_OF_MEAN|19.49||0.0221|TWO_SIDED|90.0|-71.7|-7.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 12.||-7.3|-71.7|0.0221
91499888|NCT01287897|182869659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|18.27||0.3157|TWO_SIDED|90.0|-39.0|21.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 2.||21.4|-39.0|0.3157
91741280|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|8.58|||||TWO_SIDED|80.0|-4.64|21.81||||||Week 20||21.81|-4.64|
91741281|NCT01393899|183375386|SUPERIORITY_OR_OTHER||Difference in Percentage|13.29|||||TWO_SIDED|80.0|0.15|26.43||||||Week 26||26.43|0.15|
91741282|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|6.57|||||TWO_SIDED|80.0|-8.63|21.78||||||Week 4||21.78|-8.63|
91741283|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|0.29|||||TWO_SIDED|80.0|-16.63|17.2||||||Week 8||17.20|-16.63|
91741284|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|24.29|||||TWO_SIDED|80.0|7.19|41.38||||||Week 12||41.38|7.19|
91741285|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|6.86|||||TWO_SIDED|80.0|-10.32|24.03||||||Week 20||24.03|-10.32|
91741286|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|11.29|||||TWO_SIDED|80.0|-5.22|27.79||||||Week 26||27.79|-5.22|
91741287|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|8.77|||||TWO_SIDED|80.0|-6.41|23.95||||||Week 4||23.95|-6.41|
91741288|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.0|||||TWO_SIDED|80.0|-31.59|3.59||||||Week 8||3.59|-31.59|
91741289|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|2.31|||||TWO_SIDED|80.0|-15.35|19.97||||||Week 12||19.97|-15.35|
91741290|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|10.15|||||TWO_SIDED|80.0|-7.41|27.71||||||Week 20||27.71|-7.41|
91741291|NCT01393899|183375387|SUPERIORITY_OR_OTHER||Difference in Percentage|22.0|||||TWO_SIDED|80.0|4.96|39.04||||||Week 26||39.04|4.96|
91741292|NCT01393899|183375388|SUPERIORITY_OR_OTHER||Difference in Percentage|1.83|||||TWO_SIDED|80.0|-9.75|13.4||||||||13.40|-9.75|
91741293|NCT01393899|183375388|SUPERIORITY_OR_OTHER||Difference in Percentage|18.11|||||TWO_SIDED|80.0|5.57|30.64||||||||30.64|5.57|
91741294|NCT01393899|183375389|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.75|||||TWO_SIDED|80.0|-20.39|4.88||||||||4.88|-20.39|
91741295|NCT01393899|183375389|SUPERIORITY_OR_OTHER||Difference in Percentage|17.83|||||TWO_SIDED|80.0|4.33|31.33||||||||31.33|4.33|
91741296|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.26|||=|0.0637|TWO_SIDED|80.0|-51.1|-9.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-9.42|-51.10|=0.0637
91741297|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.06|||=|0.3054|TWO_SIDED|80.0|-47.43|5.31|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||5.31|-47.43|=0.3054
91741298|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.52|||=|0.1316|TWO_SIDED|80.0|-78.57|-6.48|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-6.48|-78.57|=0.1316
91741299|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Dofference|-18.01|||=|0.5704|TWO_SIDED|80.0|-59.01|22.99|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||22.99|-59.01|=0.5704
91741300|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.0|||=|0.8389|TWO_SIDED|80.0|-44.22|32.21|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||32.21|-44.22|=0.8389
91741301|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.56|||=|0.1452|TWO_SIDED|80.0|-44.27|-2.85|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-2.85|-44.27|=0.1452
91741302|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.61|||=|0.6399|TWO_SIDED|80.0|-36.03|16.81|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||16.81|-36.03|=0.6399
91741303|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.0|||=|0.1949|TWO_SIDED|80.0|-73.57|-0.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.42|-73.57|=0.1949
91499889|NCT01287897|182869659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|18.28||0.4171|TWO_SIDED|90.0|-34.0|26.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 4.||26.4|-34.0|0.4171
91741304|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.74|||=|0.1358|TWO_SIDED|80.0|-88.62|-6.87|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-6.87|-88.62|=0.1358
91741305|NCT01393899|183375391|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.38|||=|0.089|TWO_SIDED|80.0|-88.03|-12.72|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-12.72|-88.03|=0.0890
91741306|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.44|||||TWO_SIDED|80.0|-16.14|1.26||||||Week 4||1.26|-16.14|
91741307|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.43|||||TWO_SIDED|80.0|-18.27|3.41||||||Week 8||3.41|-18.27|
91741308|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.48|||||TWO_SIDED|80.0|-25.68|0.72||||||Week 12||0.72|-25.68|
91741309|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.73|||||TWO_SIDED|80.0|-26.81|1.34||||||Week 20||1.34|-26.81|
91741310|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-18.9|||||TWO_SIDED|80.0|-39.52|1.72||||||Week 26||1.72|-39.52|
91741311|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.96|||||TWO_SIDED|80.0|-12.39|6.48||||||Week 4||6.48|-12.39|
91741312|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-10.14|13.36||||||Week 8||13.36|-10.14|
91741313|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.09|||||TWO_SIDED|80.0|-21.54|5.36||||||Week 12||5.36|-21.54|
91741314|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.9|||||TWO_SIDED|80.0|-26.99|1.19||||||Week 20||1.19|-26.99|
91741315|NCT01393899|183375392|SUPERIORITY_OR_OTHER||Difference in Percentage|-26.28|||||TWO_SIDED|80.0|-46.54|-6.02||||||Week 26||-6.02|-46.54|
91741316|NCT01393899|183375393|SUPERIORITY_OR_OTHER||Difference in Percentage|10.61|||||TWO_SIDED|80.0|-11.44|32.66||||||||32.66|-11.44|
91741317|NCT01393899|183375393|SUPERIORITY_OR_OTHER||Difference in Percentage|16.67|||||TWO_SIDED|80.0|-4.15|37.49||||||||37.49|-4.15|
91741318|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.53|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.53|-1.34|<0.0001
91741319|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.76|||=|0.0024|TWO_SIDED|95.0|-1.24|-0.28|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.28|-1.24|=0.0024
91741320|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||=|0.0044|TWO_SIDED|95.0|-1.26|-0.24|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.24|-1.26|=0.0044
91741321|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0582|TWO_SIDED|95.0|-1.13|0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||0.02|-1.13|=0.0582
91741322|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.61|||=|0.0865|TWO_SIDED|95.0|-1.31|0.09|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||0.09|-1.31|=0.0865
91741323|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.52|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.52|-1.32|<0.0001
91741324|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||=|0.0002|TWO_SIDED|95.0|-1.4|-0.45|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.45|-1.40|=0.0002
91741325|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.75|-0.71|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.71|-1.75|<0.0001
91741326|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.74|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-0.74|-1.87|<0.0001
91741327|NCT01393899|183375395|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.95|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.95|-2.30|<0.0001
91741328|NCT01393899|183375397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.39|||=|0.0566|TWO_SIDED|95.0|-0.79|0.01|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||0.01|-0.79|=0.0566
91741329|NCT01393899|183375397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|||=|0.3144|TWO_SIDED|95.0|-0.61|0.2|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||0.20|-0.61|=0.3144
91741330|NCT01393899|183375397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0434|TWO_SIDED|95.0|-1.1|-0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.02|-1.10|=0.0434
91741331|NCT01393899|183375397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.57|||=|0.005|TWO_SIDED|95.0|-0.96|-0.18|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.18|-0.96|=0.0050
91741332|NCT01393899|183375397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.66|||=|0.0017|TWO_SIDED|95.0|-1.06|-0.25|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.25|-1.06|=0.0017
91499890|NCT01287897|182869659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|18.79||0.3837|TWO_SIDED|90.0|-36.6|25.5|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 6.||25.5|-36.6|0.3837
91741333|NCT01393899|183375397|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.72|-0.67|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.67|-1.72|<0.0001
91741334|NCT01144416|183375411|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in percentage vital pregnancy|-3.0|||||TWO_SIDED|95.0|-7.4|1.4|||generalized linear model|The estimated difference in percentage vital pregnancy was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.4|-7.4|
91741335|NCT01144416|183375412|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -3 oocytes.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.2|||ANOVA|The estimated difference in number of oocytes retrieved was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs) and center.||||1.2|-0.2|
91741336|NCT01144416|183375413|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in Live Birth Rates|-2.3|||||TWO_SIDED|95.0|-6.5|1.9|||generalized linear model|The estimated difference in live birth rate was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.9|-6.5|
91741337|NCT01144416|183375414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Fisher Exact|||||||0.30
91741338|NCT01144416|183375415|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
91741339|NCT03328832|183375427|EQUIVALENCE|equivalence means p value \> 0.05||||||0.276|||||||t-test, 2 sided|||||||0.276
91741340|NCT03328832|183375428|EQUIVALENCE|equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91741341|NCT03328832|183375429|EQUIVALENCE|Equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
91741342|NCT00132301|183375444|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4|TWO_SIDED|95.0|0.58|1.11||Log rank test stratified by site.|Log Rank|||||1.11|0.58|0.40
91741343|NCT03163134|183375445|OTHER|||||||0.017|||||||Chi-squared|||||||0.017
91741344|NCT03163134|183375446|OTHER|||||||0.577|||||||Chi-squared|||||||0.577
91741345|NCT01890265|183375447|SUPERIORITY||LS mean difference|4.33|||=|0.0331|TWO_SIDED|95.0|0.35|8.3||The analysis of the change from Baseline to Week 48 in FVC (% predicted) was based on the random coefficient regression model based on observed cases.|Random coefficient regression|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in FVC (% predicted) is presented.||8.3|0.35|= 0.0331
91741346|NCT01890265|183375448|SUPERIORITY||LS mean difference|-1.8|||=|0.0236|TWO_SIDED|95.0|-3.3|-0.2|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 24 in QLF score is presented.||-0.2|-3.3|= 0.0236
91741347|NCT01890265|183375448|SUPERIORITY||LS mean difference|-3.2|||=|0.0729|TWO_SIDED|95.0|-6.6|0.3|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in QLF score is presented.||0.3|-6.6|= 0.0729
91741348|NCT01890265|183375449|SUPERIORITY||Absolute difference|-21.4|||=|0.0133|TWO_SIDED|95.0|-36.6|-6.2|||Regression, Logistic|||The absolute treatment difference (pamrevlumab - placebo) for percentage of participants with IPF progression at Week 48 is presented.||-6.2|-36.6|= 0.0133
91741349|NCT03674970|183375454|OTHER|||||||0.55|||||||ANOVA|||||||.55
91741350|NCT03674970|183375455|OTHER|||||||0.2146|||||||ANOVA|||||||.2146
91741351|NCT03674970|183375456|OTHER|||||||0.5642|||||||ANOVA|||||||.5642
91741352|NCT03674970|183375457|OTHER|||||||0.4353|||||||ANOVA|||||||.4353
91741353|NCT03674970|183375458|OTHER|||||||0.0348|||||||ANOVA|||||||.0348
91741354|NCT03674970|183375459|OTHER|||||||0.404|||||||ANOVA|||||||.4040
91741355|NCT04271540|183375476|SUPERIORITY|||||||0.35|||||||Spearman's Rank Correlation|||||||0.35
91741356|NCT02101788|183375485|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.28|1.07|||||Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.|||1.07|0.28|
91741357|NCT02101788|183375485|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.39|1.03|||||Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.|||1.03|0.39|
91741358|NCT02101788|183375485|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0929|TWO_SIDED|95.0|0.34|1.08|||Chi-squared||Estimation of mutation effect; mutant vs. wild-type in the SOC group.|Prognostic effect of the mutation status among patients in the SOC arm.||1.08|0.34|0.0929
91741359|NCT02101788|183375485|SUPERIORITY|||||||0.7195|||||||Chi-squared|||Predictive effect biomarker p-value||||0.7195
91741360|NCT04587869|183375487|SUPERIORITY||Odds Ratio (OR)|1.23||||0.44|TWO_SIDED|95.0|0.73|2.07|||Regression, Logistic|Result was adjusted for HIV status and age (dichotomized at 50+ vs. \<50), as those characteristics were used to stratify sampling|Result is for indicator of assignment to intervention arm (vs. control)|Nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.||2.07|.73|.44
91741361|NCT04587869|183375488|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.47|TWO_SIDED||||||Regression, Linear|Result was adjusted for HIV status and age (dichotomized at 50+ vs. \<50), as those characteristics were used to stratify sampling|Result is for indicator of assignment to intervention arm (vs. control)|Nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.||||.47
91741362|NCT04587869|183375489|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED||||||Regression, Linear|Result was adjusted for HIV status and age (dichotomized at 50+ vs. \<50), as those characteristics were used to stratify sampling|Slope is adjusted regression coefficient for indicator of intervention arm (so mean of outcome across follow-ups was 0.19 higher for intervention vs. control)|Unlike the two primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant. In addition, nonresponse weights were employed to account for potential bias from excluding participants who did not complete any follow-up assessments.||||.02
91741363|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|90.0|-0.57|0.43|||||6 months visit|||0.43|-0.57|
91741364|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.31|0.71|||||12 months visit|||0.71|-0.31|
91741365|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.33|0.68|||||18 months visit|||0.68|-0.33|
91741366|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|90.0|-0.71|0.26|||||6 months visit|||0.26|-0.71|
91741367|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.26|0.72|||||12 months visit|||0.72|-0.26|
91741368|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.21|0.77|||||18 months visit|||0.77|-0.21|
91741369|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.66|0.29|||||6 months visit|||0.29|-0.66|
91741370|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.19|0.75|||||12 months visit|||0.75|-0.19|
91741371|NCT01342926|183375545|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.08|0.86|||||18 months visit|||0.86|-0.08|
91741372|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|90.0|-0.34|0.61|||||6 months visit|||0.61|-0.34|
91741373|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||||TWO_SIDED|90.0|-0.07|0.89|||||12 months visit|||0.89|-0.07|
91741374|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|90.0|-0.06|0.89|||||18 months visit|||0.89|-0.06|
91741375|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|90.0|-0.55|0.37|||||6 months visit|||0.37|-0.55|
91741376|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.13|0.8|||||12 months visit|||0.80|-0.13|
91741377|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.3|0.63|||||18 months visit|||0.63|-0.30|
91741378|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.31|0.57|||||6 months visit|||0.57|-0.31|
91741379|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|90.0|0.1|0.99|||||12 months visit|||0.99|0.10|
91741380|NCT01342926|183375553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||||TWO_SIDED|90.0|0.47|1.36|||||18 months visit|||1.36|0.47|
91741381|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.34|0.55|||||6 months visit|||0.55|-0.34|
91741382|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.0|0.9|||||12 months visit|||0.90|0.00|
91741383|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.12|0.77|||||18 months visit|||0.77|-0.12|
91741384|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|90.0|-0.51|0.35|||||6 months visit|||0.35|-0.51|
91741385|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.21|0.66|||||12 months visit|||0.66|-0.21|
91741386|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.32|0.55|||||18 months visit|||0.55|-0.32|
91741387|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.48|0.35|||||6 months visit|||0.35|-0.48|
91499891|NCT01287897|182869659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|19.27||0.3204|TWO_SIDED|90.0|-40.8|22.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 8.||22.8|-40.8|0.3204
91741388|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.22|0.62|||||12 months visit|||0.62|-0.22|
91741389|NCT01342926|183375554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|90.0|0.08|0.92|||||18 months visit|||0.92|0.08|
91741390|NCT03382912|183375576|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.3|5.9|||||Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||5.9|0.3|
91741391|NCT03382912|183375577|SUPERIORITY||Hazard Ratio (HR)|1.006|||||TWO_SIDED|95.0|0.519|1.951|||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS).|||1.951|0.519|
91741392|NCT03382912|183375578|SUPERIORITY||Hazard Ratio (HR)|1.871|||||TWO_SIDED|95.0|0.772|4.532|||||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).|4.532|0.772|
91741393|NCT03382912|183375579|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.4|4.1|||||Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||4.1|0.4|
91741394|NCT01402869|183375587|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||LSD post hoc test was used for multiple group comparisons. P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in peak methemoglobin blood levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
91741395|NCT01402869|183375587|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
91741396|NCT01402869|183375587|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
91741397|NCT01402869|183375587|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.89||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.89
91741398|NCT01402869|183375588|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001|||||||ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in the time frame to peak methemoglobin levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
91741399|NCT01402869|183375588|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.43||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.43
91741400|NCT01402869|183375588|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
91741401|NCT01402869|183375588|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
91741402|NCT01402869|183375589|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||95.0||||P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in delta methemoglobin blood levels following the administration prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
91741403|NCT01402869|183375589|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
91741404|NCT01402869|183375589|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
91741405|NCT01402869|183375589|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.92||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.92
91741406|NCT00707993|183375596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||ONE_SIDED|97.5||0.13|||ANCOVA|Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.||Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI \[alpha=0.025\] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was \< 0%.||0.13||
91741407|NCT03941483|183375663|SUPERIORITY||Risk Ratio (RR)|1.174||||0.595|TWO_SIDED|90.0|0.715|1.927|||Chi-squared|||||1.927|0.715|0.595
91741408|NCT03941483|183375664|SUPERIORITY||Risk Ratio (RR)|1.297||||0.335|TWO_SIDED|90.0|0.831|2.026|||Chi-squared|||||2.026|0.831|0.335
91741409|NCT03941483|183375665|SUPERIORITY||Risk Ratio (RR)|1.025||||0.773|TWO_SIDED|90.0|0.891|1.179|||Chi-squared|||||1.179|0.891|0.773
91741410|NCT03941483|183375666|SUPERIORITY||Risk Ratio (RR)|1.038||||0.563|TWO_SIDED|90.0|0.935|1.152|||Chi-squared|||||1.152|0.935|0.563
91741411|NCT03941483|183375667|SUPERIORITY||Risk Ratio (RR)|1.174||||0.717|TWO_SIDED|90.0|0.567|2.429|||Chi-squared|||||2.429|0.567|0.717
91741412|NCT03941483|183375668|SUPERIORITY||Risk Ratio (RR)|1.614||||0.266|TWO_SIDED|90.0|0.789|3.3|||Chi-squared|||||3.300|0.789|0.266
91741413|NCT00252512|183375776|SUPERIORITY||||||<|0.001||||||Above is calculated p value, a priori threshold for significance set at \<.05|GEE full factorial modeling|||||||<.001
91741414|NCT00252512|183375777|SUPERIORITY|||||||0.015||||||a priori threshold of \<.05|t-test, 2 sided|||8 week analysis||||.015
91741415|NCT00252512|183375777|SUPERIORITY|||||||0.45||||||a priori threshold of \<.05|t-test, 2 sided|||6 month analysis||||0.45
91741416|NCT00252512|183375777|SUPERIORITY|||||||0.0497||||||a prior threshold of .05|t-test, 2 sided|||12 month analysis||||.0497
91741417|NCT00252512|183375778|SUPERIORITY||||||>|0.05||||||a priori threshold \<.05|Estimation Equation mean modeling|||Costs for period between 6 month follow-up and 12 month follow up.||||>.05
91741418|NCT00252512|183375778|SUPERIORITY||||||>|0.05|||||||Estimating Equation mean modeling|||Costs for period between 6 month follow up and 12 month follow up.||||>.05
91741419|NCT00252512|183375779|SUPERIORITY|||||||0.28||||||a priori threshold \<.05|Chi-squared|||Analysis for 8 week follow up||||.28
91741420|NCT00252512|183375779|SUPERIORITY|||||||0.013||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up||||.013
91741421|NCT00252512|183375779|SUPERIORITY|||||||0.76||||||A priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up||||.76
91741422|NCT00252512|183375780|SUPERIORITY|||||||0.66||||||A priori threshold \<.05|Chi-squared|||Analysis for 8 week follow-up||||.66
91741423|NCT00252512|183375780|SUPERIORITY|||||||0.37||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up.||||.37
91741424|NCT00252512|183375780|SUPERIORITY|||||||0.19||||||a priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up.||||.19
91741425|NCT00252512|183375781|SUPERIORITY|||||||0.05||||||A priori threshold of \<.05|Chi-squared|||Analysis for 8 week follow-up||||.05
91741426|NCT00252512|183375781|SUPERIORITY|||||||0.8||||||A priori threshold of \<.05|Chi-squared|||Analysis for 6 month follow-up.||||.80
91741427|NCT00252512|183375781|SUPERIORITY|||||||0.12||||||A priori threshold of \<.05|Chi-squared|||Analysis for 12 month follow-up.||||.12
91741428|NCT01537315|183375784|SUPERIORITY_OR_OTHER|||||||0.4521|TWO_SIDED|||||A paired comparison between baseline CRP values with values obtained after 1, 3, and 6 months of treatment was conducted, with a p-value of 0.05 used as the a priori threshold of statistical significance.|ANOVA|||||||0.4521
91741429|NCT03458325|183375792|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||-11,802.70|-22,187.90|<0.0001
91741430|NCT03458325|183375793|SUPERIORITY||Percentage Difference|-6.4||||0.6765|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.6765
91741431|NCT03458325|183375794|SUPERIORITY||Mean Difference (Net)|5.3||||0.5856|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.5856
91741432|NCT03458325|183375795|SUPERIORITY||Mean Difference (Net)|-1.9||||1|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||1.000
91499892|NCT01287897|182869659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9|STANDARD_ERROR_OF_MEAN|19.64||0.0649|TWO_SIDED|90.0|-62.3|2.6|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 10.||2.6|-62.3|0.0649
91741433|NCT03458325|183375796|SUPERIORITY||Mean Difference (Net)|65.1|||<|0.0001|TWO_SIDED||||||Chi-squared|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||<0.0001
91741434|NCT03458325|183375797|SUPERIORITY||Mean Difference (Net)|12.8||||0.0443|TWO_SIDED|95.0|0.4|25.3|||t-test, 2 sided|P-value was obtained from the paired t-test statistic.||Analysis for Summary Score||25.3|0.4|0.0443
91741435|NCT03458325|183375798|SUPERIORITY|Statistical Analysis for the mean change in NT-proBNP over 30 days|Mean Difference (Final Values)|-122.6||||0.5133|TWO_SIDED|95.0|-525.8|280.5|||t-test, 2 sided|||||280.5|-525.8|0.5133
91741436|NCT03458325|183375798|SUPERIORITY||Mean Difference (Final Values)|-719.9||||0.042|TWO_SIDED|95.0|-1406.5|-33.2|||t-test, 2 sided|||Statistical Analysis for mean change in BNP over 30 days||-33.2|-1406.5|0.0420
91741437|NCT02440139|183375826|SUPERIORITY||difference in sensitivity|-0.124|STANDARD_DEVIATION|0.034|<|0.05|TWO_SIDED|95.0|-0.186|-0.062|||Mixed Models Analysis|||||-0.062|-0.186|<0.05
91741438|NCT02440139|183375827|SUPERIORITY||Difference in LROC curves|-0.14|STANDARD_DEVIATION|0.039|<|0.05|TWO_SIDED|95.0|-0.209|-0.071|||ANOVA|||For each study arm, the difference in the least-squares means of the two arms was estimated. A two-sided 95% confidence interval on this difference in study arms (i.e. unaided minus aided by the software) was used to test the hypothesis that the difference in the area under the LROC curve (AUC). The superiority of ClearRead CT will be concluded if the upper bound of the two-sided 95% confidence interval on the difference is less than zero.||-0.071|-0.209|<0.05
91741439|NCT00412958|183375861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.796|TWO_SIDED|95.0|0.24|6.36|||Regression, Logistic|||P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||6.36|0.24|0.796
91531236|NCT04179461|182939093|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data and the Bowker's test was used to compare categorical FEV1-FVC data. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.27||||||The Change in FEV1/FVC from Visit 1 to Visit 3|Wilcoxon (Mann-Whitney)|||||||0.27
91741440|NCT00412958|183375861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.447|TWO_SIDED|95.0|0.39|8.36|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||8.36|0.39|0.447
91741441|NCT00412958|183375861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.107|TWO_SIDED|95.0|0.77|13.95|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||13.95|0.77|0.107
91741442|NCT03579693|183375934|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.33|TWO_SIDED|95.0|-0.43|1.31|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.31|-0.43|0.33
91741443|NCT03579693|183375934|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.93|TWO_SIDED|95.0|-0.9|0.82|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.82|-0.90|0.93
91741444|NCT03579693|183375935|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.05|TWO_SIDED|95.0|-3.47|0.0|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.00|-3.47|0.050
91741445|NCT03579693|183375935|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.47|TWO_SIDED|95.0|-2.28|1.05|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.05|-2.28|0.47
91741446|NCT04970069|183375936|SUPERIORITY||Ratio of geometric means|1.01||||0.89|TWO_SIDED|95.0|0.86|1.18|||Regression, Linear||The numerator and denominator for the ratio of geometric means are analgesic education and general preoperative education respectively.|Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.||1.18|0.86|0.890
91741447|NCT04970069|183375937|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.617
91741448|NCT04970069|183375938|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.611
91741449|NCT00503425|183375940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 1.|t-test, 2 sided|||||||<0.0001
91741450|NCT00503425|183375940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 2.|t-test, 2 sided|||||||<0.0001
91741451|NCT00503425|183375940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 3.|t-test, 2 sided|||||||<0.0001
91741452|NCT00503425|183375940|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 4.|t-test, 2 sided|||||||0.0001
91741453|NCT00003869|183375954|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||||||0.54
91741454|NCT00003869|183375955|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
91741455|NCT00003869|183375956|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Log Rank|||||||0.50
91741456|NCT00003869|183375957|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||||||0.04
91741457|NCT00003869|183375958|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
91741458|NCT00763256|183375960|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91741459|NCT00763256|183375961|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91741460|NCT00763256|183375962|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91741461|NCT00763256|183375963|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91741462|NCT00763256|183375964|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
91741463|NCT02622295|183375971|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91741464|NCT02622295|183375972|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91741465|NCT02622295|183375973|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91741466|NCT02622295|183375974|SUPERIORITY|||||||0.467|||||||ANOVA|||||||0.467
91741467|NCT02622295|183375975|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91741468|NCT02622295|183375976|SUPERIORITY|||||||0.932|||||||ANOVA|||||||0.932
91741469|NCT02622295|183375977|SUPERIORITY|||||||0.326|||||||ANOVA|||||||0.326
91741470|NCT02622295|183375978|SUPERIORITY|||||||0.673|||||||ANOVA|||||||0.673
91741471|NCT02622295|183375979|SUPERIORITY|||||||0.539|||||||ANOVA|||||||0.539
91741472|NCT02622295|183375980|SUPERIORITY|||||||0.155|||||||ANOVA|||||||0.155
91741473|NCT02622295|183375981|SUPERIORITY|||||||0.164|||||||ANOVA|||||||0.164
91741474|NCT02622295|183375982|SUPERIORITY|||||||0.493|||||||ANOVA|||||||0.493
91741475|NCT02622295|183375983|SUPERIORITY|||||||0.458|||||||ANOVA|||||||0.458
91499893|NCT01287897|182869659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|19.87||0.0598|TWO_SIDED|90.0|-63.9|1.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 12.||1.8|-63.9|0.0598
91741476|NCT02720523|183376011|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|14.3|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||51.0|14.3|<0.001
91741477|NCT02720523|183376011|SUPERIORITY||Response Rate Difference|40.8|||<|0.001|TWO_SIDED|95.0|23.5|58.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.1|23.5|<0.001
91741478|NCT02720523|183376011|SUPERIORITY||Response Rate Difference|37.1|||<|0.001|TWO_SIDED|95.0|19.4|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||54.9|19.4|<0.001
91741479|NCT02720523|183376011|OTHER|Cochran-Armitage test was conducted for demonstrating a dose response relationship.|||||<|0.001|||||||Cochran-Armitage test|||||||<0.001
91741480|NCT02720523|183376012|SUPERIORITY||Least Squares (LS) Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.693|-0.88|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-0.880|-1.693|<0.001
91741481|NCT02720523|183376012|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.005|-1.19|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.190|-2.005|<0.001
91741482|NCT02720523|183376012|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001|TWO_SIDED|95.0|-2.027|-1.216|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.216|-2.027|<0.001
91741483|NCT02720523|183376013|SUPERIORITY||LS Mean Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-0.465|-0.144|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.144|-0.465|<0.001
91741484|NCT02720523|183376013|SUPERIORITY||LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.505|-0.184|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.184|-0.505|<0.001
91741485|NCT02720523|183376013|SUPERIORITY||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.55|-0.229|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.229|-0.550|<0.001
91741486|NCT02720523|183376014|SUPERIORITY||Response Rate Difference|24.5||||0.007|TWO_SIDED|95.0|7.3|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.7|7.3|0.007
91741487|NCT02720523|183376014|SUPERIORITY||Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|32.1|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||65.9|32.1|<0.001
91741488|NCT02720523|183376014|SUPERIORITY||Response Rate Difference|41.7|||<|0.001|TWO_SIDED|95.0|24.5|58.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.8|24.5|<0.001
91499894|NCT00786487|182869708|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91499895|NCT00786487|182869708|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91499896|NCT01500629|182869709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.156|TWO_SIDED|95.0|-1.9|0.33|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.33|-1.90|0.156
91499897|NCT01500629|182869710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.625|TWO_SIDED|95.0|-1.49|0.92|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.92|-1.49|0.625
91741489|NCT02720523|183376015|SUPERIORITY||Response Rate Difference|18.4||||0.004|TWO_SIDED|95.0|6.4|30.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.3|6.4|0.004
91741490|NCT02720523|183376015|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|18.7|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||46.6|18.7|<0.001
91741491|NCT02720523|183376015|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|12.9|39.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|12.9|<0.001
91741492|NCT02720523|183376016|SUPERIORITY||LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|2.1|6.57|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||6.57|2.10|<0.001
91741493|NCT02720523|183376016|SUPERIORITY||LS Mean Difference|3.5||||0.002|TWO_SIDED|95.0|1.25|5.75|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.75|1.25|0.002
91741494|NCT02720523|183376016|SUPERIORITY||LS Mean Difference|5.93|||<|0.001|TWO_SIDED|95.0|3.64|8.22|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||8.22|3.64|<0.001
91741495|NCT02720523|183376017|SUPERIORITY||Response Rate Difference|34.7|||<|0.001|TWO_SIDED|95.0|17.0|52.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||52.4|17.0|<0.001
91741496|NCT02720523|183376017|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|34.2|67.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||67.9|34.2|<0.001
91741497|NCT02720523|183376017|SUPERIORITY||Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.1|70.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||70.1|37.1|<0.001
91741498|NCT02720523|183376018|SUPERIORITY||Response Rate Difference|30.6|||<|0.001|TWO_SIDED|95.0|15.5|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||45.7|15.5|<0.001
91741499|NCT02720523|183376018|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|35.6|66.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||66.4|35.6|<0.001
91741500|NCT02720523|183376018|SUPERIORITY||Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|28.5|59.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||59.3|28.5|<0.001
91741501|NCT02720523|183376019|SUPERIORITY||Response Rate Difference|22.4||||0.006|TWO_SIDED|95.0|7.4|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||37.5|7.4|0.006
91741502|NCT02720523|183376019|SUPERIORITY||Response Rate Difference|16.3||||0.026|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.6|2.1|0.026
91741503|NCT02720523|183376019|SUPERIORITY||Response Rate Difference|25.8||||0.002|TWO_SIDED|95.0|10.6|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.0|10.6|0.002
91741504|NCT02720523|183376020|SUPERIORITY||LS Mean Difference|2.66||||0.04|TWO_SIDED|95.0|0.12|5.2|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.20|0.12|0.040
91741505|NCT02720523|183376020|SUPERIORITY||LS Mean Difference|1.79||||0.169|TWO_SIDED|95.0|-0.77|4.35|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||4.35|-0.77|0.169
91741506|NCT02720523|183376020|SUPERIORITY||LS Mean Difference|0.85||||0.516|TWO_SIDED|95.0|-1.73|3.43|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||3.43|-1.73|0.516
91499898|NCT01500629|182869711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.291|TWO_SIDED|95.0|-2.12|0.67|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.67|-2.12|0.291
91741507|NCT02720523|183376021|SUPERIORITY||LS Mean Difference|-2.54||||0.021|TWO_SIDED|95.0|-4.68|-0.39|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-0.39|-4.68|0.021
91741508|NCT02720523|183376021|SUPERIORITY||LS Mean Difference|-2.06||||0.08|TWO_SIDED|95.0|-4.36|0.25|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.25|-4.36|0.080
91741509|NCT02720523|183376021|SUPERIORITY||LS Mean Difference|-1.56||||0.22|TWO_SIDED|95.0|-4.06|0.94|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.94|-4.06|0.220
91741510|NCT02720523|183376022|SUPERIORITY||LS Mean Difference|-1.81|||<|0.001|TWO_SIDED|95.0|-2.57|-1.04|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.04|-2.57|<0.001
91741511|NCT02720523|183376022|SUPERIORITY||LS Mean Difference|-1.82|||<|0.001|TWO_SIDED|95.0|-2.59|-1.05|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.05|-2.59|<0.001
91741512|NCT02720523|183376022|SUPERIORITY||LS Mean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.73|-1.18|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.18|-2.73|<0.001
91741513|NCT00125788|183376055|SUPERIORITY|||||||0.076|||||||Cochran-Mantel-Haenszel|||||||0.076
91741514|NCT00125788|183376056|SUPERIORITY|||||||0.072|||||||Cochran-Mantel-Haenszel|||||||0.072
91741515|NCT00125788|183376057|SUPERIORITY|||||||0.129|||||||Cochran-Mantel-Haenszel|||||||0.129
91741516|NCT03008070|183376079|SUPERIORITY||Risk Ratio (RR)|1.52|||=|0.061|TWO_SIDED|95.0|0.98|2.12|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 800 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.12|0.98|=0.061
91741517|NCT03008070|183376079|SUPERIORITY||Risk Ratio (RR)|1.82|||=|0.004|TWO_SIDED|95.0|1.24|2.4|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 1200 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.4|1.24|=0.004
91741518|NCT04409834|183376114|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.95||||0.028|TWO_SIDED|95.0|1.08|3.55|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.55|1.08|0.028
91741519|NCT04409834|183376115|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.79||||0.087|TWO_SIDED|95.0|0.92|3.47|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.47|0.92|0.087
91741520|NCT04409834|183376116|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.04||||0.9|TWO_SIDED|95.0|0.54|2.01|||Stratified Win-Ratio Analysis, 2-sided|||||2.01|0.54|0.90
91741521|NCT04409834|183376117|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|0.79||||0.53|TWO_SIDED|95.0|0.38|1.65|||Stratified Win-Ratio Analysis, 2-sided|||||1.65|0.38|0.53
91741522|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.505|TWO_SIDED|95.0|0.24|2.03|||Unstratified log-rank|||||2.03|0.24|0.5050
91499899|NCT01500629|182869712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.899|TWO_SIDED|95.0|-1.21|1.07|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.07|-1.21|0.899
91499900|NCT01500629|182869713|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.701||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.701
91741523|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.6284|TWO_SIDED|95.0|0.22|2.54|||Unstratified log-rank|||||2.54|0.22|0.6284
91741524|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1988|TWO_SIDED|95.0|0.4|1.22|||Unstratified log-rank|||||1.22|0.40|0.1988
91741525|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2722|TWO_SIDED|95.0|0.42|1.28|||Unstratified log-rank|||||1.28|0.42|0.2722
91741526|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0544|TWO_SIDED|95.0|0.17|1.04|||Unstratified log-rank|||||1.04|0.17|0.0544
91741527|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|2.04||||0.0442|TWO_SIDED|95.0|1.0|4.16|||Unstratified log-rank|||||4.16|1.00|0.0442
91741528|NCT02574078|183376148|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5489|TWO_SIDED|95.0|0.5|1.45|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.45|0.50|0.5489
91741529|NCT02574078|183376149|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.35|2.91|||Unstratified log-rank|||||2.91|0.35|0.9951
91741530|NCT02574078|183376149|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.8321|TWO_SIDED|95.0|0.25|3.1|||Unstratified log-rank|||||3.10|0.25|0.8321
91741531|NCT02574078|183376149|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2938|TWO_SIDED|95.0|0.41|1.31|||Unstratified log-rank|||||1.31|0.41|0.2938
91741532|NCT02574078|183376149|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4819|TWO_SIDED|95.0|0.46|1.45|||Unstratified log-rank|||||1.45|0.46|0.4819
91741533|NCT02574078|183376149|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0241|TWO_SIDED|95.0|0.11|0.91|||Unstratified log-rank|||||0.91|0.11|0.0241
91741534|NCT02574078|183376149|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.1401|TWO_SIDED|95.0|0.85|2.95|||Unstratified log-rank|||||2.95|0.85|0.1401
91741535|NCT02574078|183376153|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2862|TWO_SIDED|95.0|0.4|1.31|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.31|0.40|0.2862
91741536|NCT01530178|183376168|OTHER|Non-specified|Mean Difference (Final Values)|-27.91||||0.003|TWO_SIDED|95.0|-44.7|-11.2|||ANOVA|||||-11.2|-44.7|0.003
91741537|NCT01530178|183376168|OTHER|Non-specified|Mean Difference (Final Values)|-2.131||||0.68|TWO_SIDED|95.0|-12.91|8.652|||ANOVA|||||8.652|-12.91|0.68
91741538|NCT01530178|183376168|OTHER||Mean Difference (Final Values)|-25.78||||0.0005|TWO_SIDED|95.0|-38.39|-13.17|||ANOVA|||||-13.17|-38.39|0.0005
91741539|NCT03980743|183376196|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24)||||0.97
91741540|NCT03980743|183376197|SUPERIORITY|||||||0.273|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24) for Healthy Eating||||0.273
91741541|NCT03980743|183376198|SUPERIORITY|Time x treatment (week 0 and week 24) with sum score||||||0.691|||||||Mixed Models Analysis|||||||0.691
91741542|NCT02709512|183376199|SUPERIORITY|Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.|Risk Ratio (RR)|1.02||||0.9489|TWO_SIDED|95.0|0.5|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.50|0.9489
91741543|NCT02709512|183376200|SUPERIORITY||Cox Proportional Hazard|0.64||||0.0078|TWO_SIDED|95.0|0.47|0.88|||Log Rank|||||0.88|0.47|0.0078
91499901|NCT01500629|182869714|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.108||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.108
91741544|NCT02709512|183376201|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0234|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||||0.93|0.55|0.0234
91499902|NCT01500629|182869715|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.253||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.253
91741545|NCT02709512|183376202|SUPERIORITY||Cox Proportional Hazard|0.65||||0.0193|TWO_SIDED|95.0|0.46|0.9|||Log Rank|||||0.90|0.46|0.0193
91741546|NCT01834287|183376206|SUPERIORITY||Mean Difference (Final Values)|31.0||||0.001|TWO_SIDED|95.0|9.6|52.4|||Regression, Linear|||||52.4|9.6|.001
91499903|NCT01500629|182869716|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.287||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.287
91499904|NCT01500629|182869717|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.409||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.409
91741547|NCT00276406|183376213|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||<0.01
91741548|NCT00276406|183376217|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||0.096
91741549|NCT00276406|183376218|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
91741550|NCT00276406|183376219|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||0.005
91741551|NCT00276406|183376220|SUPERIORITY_OR_OTHER||||||<|0.04||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||<0.04
91499905|NCT01500629|182869718|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.092||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.092
91499906|NCT01500629|182869719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.042||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.042
91499907|NCT01500629|182869720|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.307||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.307
91741552|NCT02297815|183376230|SUPERIORITY_OR_OTHER||Score difference|-1.4||||0.008|TWO_SIDED|95.0|-2.44|-0.36|||Weighted linear regression|Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.|Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.||-0.36|-2.44|0.008
91531237|NCT04179461|182939094|EQUIVALENCE|Intervention adherence and end of study adherence were each calculated based on the 30 days prior to end of intervention and V3, respectively, in order to assess a consistent timeframe. The paired Wilcoxon signed rank test was conducted to compare controller inhaler adherence during baseline, adherence intervention, and end of study.||||||0.17||||||Change between baseline (V1) to end of study (V3)|Wilcoxon (Mann-Whitney)|||||||0.17
91741553|NCT02297815|183376231|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||7.9|-3.1|0.39
91741554|NCT02297815|183376232|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.59|TWO_SIDED|95.0|-3.9|6.8|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||6.8|-3.9|0.59
91741555|NCT02297815|183376233|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||17.2|7.3|<0.001
91741556|NCT02297815|183376234|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.9||||0.09|TWO_SIDED|95.0|-0.8|10.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||10.6|-0.8|0.09
91741557|NCT02297815|183376235|SUPERIORITY||Risk Difference (RD)|4.6||||0.07|TWO_SIDED|95.0|-0.3|9.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||9.6|-0.3|0.07
91741558|NCT01734785|183376255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.93|-0.46|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.46|-0.93|<0.0001
91741559|NCT01734785|183376255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.02|-0.55|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.55|-1.02|<0.0001
91741560|NCT01734785|183376256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.61|-1.57|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.57|-2.61|<0.0001
91741561|NCT01734785|183376256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.31|-1.28|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.28|-2.31|<0.0001
91741562|NCT01734785|183376257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-2.92|-1.52|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.52|-2.92|<0.0001
91741563|NCT01734785|183376257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-3.47|-2.07|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-2.07|-3.47|<0.0001
91741564|NCT02397915|183376258|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
91741565|NCT02397915|183376259|SUPERIORITY_OR_OTHER|||||||0.065||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute scent/odor.|Cochran-Mantel-Haenszel|||||||0.065
91741566|NCT02397915|183376259|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute immediate taste.|Cochran-Mantel-Haenszel|||||||0.532
91741567|NCT02397915|183376259|SUPERIORITY_OR_OTHER|||||||0.138||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute after taste.|Cochran-Mantel-Haenszel|||||||0.138
91741568|NCT02397915|183376259|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LDTT.|Cochran-Mantel-Haenszel|||||||<0.001
91741569|NCT02397915|183376259|SUPERIORITY_OR_OTHER|||||||0.017||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LRON.|Cochran-Mantel-Haenszel|||||||0.017
91741570|NCT02397915|183376259|SUPERIORITY_OR_OTHER|||||||0.046||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute more soothing.|Cochran-Mantel-Haenszel|||||||0.046
91741571|NCT02397915|183376259|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute less irritating.|Cochran-Mantel-Haenszel|||||||<0.001
91741572|NCT02397915|183376259|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute UTS.|Cochran-Mantel-Haenszel|||||||0.532
91741573|NCT02397915|183376260|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
91741574|NCT02397915|183376261|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
91741575|NCT02397915|183376262|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
91741576|NCT02397915|183376263|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.179||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.179
91741577|NCT02397915|183376264|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
91741578|NCT02397915|183376265|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
91741579|NCT02397915|183376266|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
91741580|NCT02397915|183376267|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
91741581|NCT02397915|183376268|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.188||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.188
91741582|NCT02397915|183376269|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
91741583|NCT02397915|183376270|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
91741584|NCT02397915|183376271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
91741585|NCT02397915|183376272|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.004||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.004
91741586|NCT02397915|183376273|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.223||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.223
91741587|NCT02397915|183376274|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
91741588|NCT02397915|183376275|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.008||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.008
91741589|NCT02397915|183376276|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.831||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.831
91741590|NCT02397915|183376277|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
91741591|NCT02397915|183376278|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.007||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.007
91741592|NCT02397915|183376279|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.568||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.568
91741593|NCT02397915|183376280|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
91741594|NCT00368745|183376281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2838||95.0||||significance determined using 2-tailed significance level of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with country as a covariate||Primary objective: evaluate the efficacy of pregabalin in maintaining the benzodiazepine free state in subjects with prior stable alprazolam use.||||0.2838
91741595|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.81||0.0709||95.0|-3.1|0.13||contrasts performed using Dunnett's Test|ANCOVA|Least squares (LS) Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||0.13|-3.10|0.0709
91499908|NCT01500629|182869721|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.903||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.903
91499909|NCT01500629|182869722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.121||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.121
91499910|NCT01500629|182869723|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.689||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.689
91499911|NCT01500629|182869724|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.314||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.314
91741596|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|1.08||0.0006||95.0|-6.04|-1.74||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-1.74|-6.04|0.0006
91741597|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.3||0.0718||95.0|-4.98|0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.22|-4.98|0.0718
91741598|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.38|STANDARD_ERROR_OF_MEAN|1.92||0.092||95.0|-7.37|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.60|-7.37|0.0920
91741599|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|3.04||0.1371||95.0|-12.67|2.23||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT week 5||2.23|-12.67|0.1371
91741600|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.04||0.0882||95.0|-7.96|0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.61|-7.96|0.0882
91741601|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|STANDARD_ERROR_OF_MEAN|1.11||0.0135||95.0|-5.05|-0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.61|-5.05|0.0135
91741602|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.18||0.3924||95.0|-3.38|1.35||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||1.35|-3.38|0.3924
91741603|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.14||0.3868||95.0|-3.29|1.3||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||1.30|-3.29|0.3868
91741604|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.15||0.9966||95.0|-2.31|2.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||2.32|-2.31|0.9966
91741605|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.26||0.6873||95.0|-3.07|2.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||2.05|-3.07|0.6873
91741606|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.35||0.5337||95.0|-3.62|1.91||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||1.91|-3.62|0.5337
91741607|NCT00368745|183376282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.79|STANDARD_ERROR_OF_MEAN|1.37||0.0008||95.0|-7.51|-2.07||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-2.07|-7.51|0.0008
91741608|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|1.4||0.122||95.0|-4.97|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.60|-4.97|0.1220
91741609|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.63|STANDARD_ERROR_OF_MEAN|1.26||0.0053||95.0|-6.15|-1.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-1.11|-6.15|0.0053
91741610|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|1.73||0.1048||95.0|-6.32|0.62||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.62|-6.32|0.1048
91741611|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.52||0.0357||95.0|-6.57|-0.25||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||-0.25|-6.57|0.0357
91741612|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|2.67||0.4263||95.0|-8.82|4.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||4.26|-8.82|0.4263
91741613|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.73|STANDARD_ERROR_OF_MEAN|2.02||0.0104||95.0|-9.96|-1.51||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||-1.51|-9.96|0.0104
91741614|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.4||0.0069||95.0|-6.73|-1.12||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-1.12|-6.73|0.0069
91741615|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.37||0.2185||95.0|-4.47|1.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||1.05|-4.47|0.2185
91741616|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.06||0.7832||95.0|-2.41|1.83||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||1.83|-2.41|0.7832
91741617|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.16||0.7062||95.0|-1.9|2.79||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||2.79|-1.90|0.7062
91741618|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.04||0.7161||95.0|-2.49|1.73||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||1.73|-2.49|0.7161
91741619|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|1.43||0.0376||95.0|-6.03|-0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.19|-6.03|0.0376
91741620|NCT00368745|183376285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.48||0.0122||95.0|-6.74|-0.85||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.85|-6.74|0.0122
91741621|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0052||95.0|-0.76|-0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||-0.14|-0.76|0.0052
91741622|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.18||0.0001||95.0|-1.11|-0.38||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-0.38|-1.11|0.0001
91741623|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0528||95.0|-1.0|0.01||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.01|-1.00|0.0528
91499912|NCT01500629|182869725|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.034||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.034
91741624|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.3085||95.0|-1.11|0.37||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.37|-1.11|0.3085
91741625|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.47||0.1807||95.0|-1.92|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 5||0.47|-1.92|0.1807
91741626|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.42||0.1074||95.0|-1.58|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.17|-1.58|0.1074
91741627|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0013||95.0|-1.1|-0.28||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.28|-1.10|0.0013
91499913|NCT01500629|182869726|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.845||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.845
91499914|NCT01500629|182869727|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.619||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.619
91741628|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0503||95.0|-0.99|0.0||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||0.00|-0.99|0.0503
91741629|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.26||0.0364||95.0|-1.09|-0.04||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||-0.04|-1.09|0.0364
91499915|NCT01500629|182869728|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.803||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.803
91499916|NCT01500629|182869729|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.175||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.175
91499917|NCT01500629|182869730|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.206|||||||Wilcoxon (Mann-Whitney)|The rank sum test was based on period difference for comparison between sequence.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.206
91499918|NCT01500629|182869731|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.072||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.072
91741630|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.914||95.0|-0.51|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||0.46|-0.51|0.9140
91741631|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.27||0.7789||95.0|-0.62|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||0.47|-0.62|0.7789
91741632|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.3189||95.0|-0.95|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||0.32|-0.95|0.3189
91741633|NCT00368745|183376287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0031||95.0|-1.26|-0.27||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-0.27|-1.26|0.0031
91741634|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.126||95.0|-0.86|0.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.11|-0.86|0.1260
91741635|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.29||0.0074||95.0|-1.4|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.40|0.0074
91741636|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.125||95.0|-1.35|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.17|-1.35|0.1250
91741637|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.6||0.8991||95.0|-1.17|1.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.32|-1.17|0.8991
91741638|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.53||0.1747||95.0|-2.07|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.46|-2.07|0.1747
91741639|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.45||0.0744||95.0|-1.79|0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.09|-1.79|0.0744
91741640|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.35||0.0063||95.0|-1.67|-0.29||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-0.29|-1.67|0.0063
91741641|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.34||0.014||95.0|-1.56|-0.18||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||-0.18|-1.56|0.0140
91741642|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0267||95.0|-1.46|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||-0.09|-1.46|0.0267
91741643|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.38||0.5104||95.0|-1.03|0.52||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.52|-1.03|0.5104
91741644|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.43||0.2702||95.0|-1.35|0.39||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.39|-1.35|0.2702
91741645|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.42||0.1241||95.0|-1.52|0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||0.19|-1.52|0.1241
91499919|NCT01500629|182869732|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.014||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||.0140
91741646|NCT00368745|183376288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.36||0.0109||95.0|-1.67|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.22|-1.67|0.0109
91741647|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.28||0.0226||95.0|-1.22|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||-0.09|-1.22|0.0226
91741648|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34||0.0099||95.0|-1.58|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.58|0.0099
91741649|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.35||0.2827||95.0|-1.07|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.32|-1.07|0.2827
91741650|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.58||0.8232||95.0|-1.07|1.34||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.34|-1.07|0.8232
91741651|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.2409||95.0|-2.41|0.72||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.72|-2.41|0.2409
91741652|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.61||0.476||95.0|-1.73|0.84||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.84|-1.73|0.4760
91741653|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1252||95.0|-1.14|0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||0.14|-1.14|0.1252
91741654|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0717||95.0|-1.26|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||0.06|-1.26|0.0717
91741655|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.35||0.0707||95.0|-1.33|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||0.06|-1.33|0.0707
91741656|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.4341||95.0|-1.08|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.47|-1.08|0.4341
91741657|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.42||0.37||95.0|-1.23|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.47|-1.23|0.3700
91741658|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.43||0.0328||95.0|-1.83|-0.08||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.08|-1.83|0.0328
91741659|NCT00368745|183376289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.39||0.0096||95.0|-1.8|-0.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.26|-1.80|0.0096
91741660|NCT00368745|183376290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|2.68||0.8897||95.0|-5.74|4.99||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as the covariate||||4.99|-5.74|0.8897
91741661|NCT00368745|183376291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0626||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0626
91741662|NCT00368745|183376292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0148
91741663|NCT00368745|183376293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1159||95.0||||p-value is obtained using Cochran-Mantel-Haenszel option|Cochran-Mantel-Haenszel|||||||0.1159
91741664|NCT02476032|183376294|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
91741665|NCT02476032|183376295|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
91741666|NCT00293813|183376296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||||95.0|2.6|5.7|||ANCOVA|||||5.7|2.6|
91741667|NCT00293813|183376296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||||95.0|-0.6|2.6|||ANCOVA|||||2.6|-.6|
91741668|NCT02553928|183376369|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.19||0.097|TWO_SIDED|95.0|-0.06|0.69||Based on full analysis set|ANCOVA||The comparison is to BID memantine.|The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.||0.69|-0.06|0.097
91741669|NCT05507567|183376370|OTHER|||||||0.0331|||||||Chi-squared|||A priori primary analysis group||||0.0331
91741670|NCT05507567|183376371|OTHER|||||||0.1427||||||Hodges-Lehmann (H-L) estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1427
91741671|NCT05507567|183376372|OTHER|||||||0.1307||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1307
91741672|NCT05507567|183376373|OTHER|||||||0.0382||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0382
91741673|NCT05507567|183376374|OTHER|||||||0.011||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0110
91741674|NCT04830215|183376379|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
91741675|NCT04830215|183376380|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
91741676|NCT00770562|183376385|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
91741677|NCT00770562|183376386|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
91741678|NCT00770562|183376387|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher Exact|||||||0.015
91741679|NCT01194219|183376388|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.8|||<|0.0001|TWO_SIDED|95.0|23.1|32.5|||Chi-squared|||||32.5|23.1|<0.0001
91741680|NCT01194219|183376389|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|21.9|||Chi-squared|||||21.9|13.7|<0.0001
91741681|NCT01194219|183376390|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-40.78|||<|0.0001|TWO_SIDED|95.0|-46.34|-35.21|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-35.21|-46.34|<0.0001
91741682|NCT01194219|183376391|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-30.6|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-30.6|-39.9|<0.0001
91741683|NCT01194219|183376392|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|35.7|47.7|||Chi-squared|||||47.7|35.7|<0.0001
91741684|NCT01194219|183376393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-28.7|-19.8|||ANOVA|Based on an analysis of variance model for the change from baseline at Week 16, with treatment group as a factor (an ANOVA model).||||-19.8|-28.7|<0.0001
91741685|NCT01194219|183376394|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.4|-3.6|||ANOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor, the baseline value, and the treatment by baseline interaction term as covariates.|||-3.6|-5.4|<0.0001
91741686|NCT01194219|183376395|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.08|||<|0.0001|TWO_SIDED|95.0|1.81|4.35|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.35|1.81|<0.0001
91741687|NCT01194219|183376396|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.7|||<|0.0001|TWO_SIDED|95.0|12.8|20.7|||Chi-squared|||||20.7|12.8|<0.0001
91741688|NCT01194219|183376397|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.649|||<|0.0001|TWO_SIDED|95.0|1.768|3.969|||Log Rank|||||3.969|1.768|<0.0001
91741689|NCT01081951|183376412|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0012|TWO_SIDED|95.0|0.34|0.77||The use of a one-sided 10% significance level test will be used to assess the statistical significance of the analyses of PFS.|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio of \< 1 favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||0.77|0.34|0.0012
91741690|NCT01081951|183376413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.4379|TWO_SIDED|95.0|0.79|1.73||Two sided|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio \< 1 favours favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||1.73|0.79|0.4379
91741691|NCT05226598|183376423|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.8335|TWO_SIDED|95.0|0.87|1.5||One-sided p-value based on log-rank test stratified by ECOG, predominant tumor histology, PD-L1 expression, and geographic region|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by ECOG, predominant tumor histology, PD-L1 expression, and geographic region|||1.50|0.87|0.8335
91741692|NCT05226598|183376424|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5104|TWO_SIDED|95.0|0.82|1.23||One-sided p-value based on log-rank test stratified by ECOG, predominant tumor histology, PD-L1 expression, and geographic region|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by ECOG, predominant tumor histology, PD-L1 expression, and geographic region|||1.23|0.82|0.5104
91741693|NCT04503551|183376442|SUPERIORITY||CMH Weighted Percentage Difference|71.1|||<|0.0001|TWO_SIDED|95.04|61.0|81.2|||Cochran-Mantel-Haenszel|Stratification was done by baseline ETDRS-DRSS level (47 vs.53) \& baseline intraretinal/subretinal fluid status on SD-OCT (present vs. absent).||||81.2|61.0|<0.0001
91741694|NCT04503551|183376443|SUPERIORITY||Stratified Hazard Ratio|0.1|||<|0.0001|TWO_SIDED|95.04|0.1|0.3|||Stratified Log-Rank||||A stratified log-rank test was used for hypothesis testing comparing the PDS arm with the comparator arm. A Cox proportional hazards regression model (stratified) was used as a supportive analysis to estimate the Hazard ratio (HR).|0.3|0.1|< 0.0001
91741695|NCT04503551|183376444|SUPERIORITY||Stratified Hazard Ratio|0.1|||<|0.0001|TWO_SIDED|95.04|0.1|0.1|||Stratified Log-Rank||||A stratified log-rank test was used for hypothesis testing comparing the PDS arm with the comparator arm. A Cox proportional hazards regression model (stratified) was used as a supportive analysis to estimate the HR.|0.1|0.1|< 0.0001
91499920|NCT01500629|182869733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.907|TWO_SIDED|95.0|-0.24|0.22|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.22|-0.24|0.907
91741696|NCT04503551|183376445|SUPERIORITY||Stratified Hazard Ratio|0.1|||<|0.0001|TWO_SIDED|95.04|0.1|0.3|||Stratified Log-Rank||||A stratified log-rank test was used for hypothesis testing comparing the PDS arm with the comparator arm. A Cox proportional hazards regression model (stratified) was used as a supportive analysis to estimate the HR.|0.3|0.1|<0.0001
91741697|NCT04503551|183376446|SUPERIORITY||Stratified Hazard Ratio|0.1|||<|0.0001|TWO_SIDED|95.04|0.1|0.2|||Stratified Log-Rank||||A stratified log-rank test was used for hypothesis testing comparing the PDS arm with the comparator arm. A Cox proportional hazards regression model (stratified) was used as a supportive analysis to estimate the HR.|0.2|0.1|<0.0001
91741698|NCT04503551|183376447|SUPERIORITY||Percentage Difference|15.1||||0.0003|TWO_SIDED|95.04|8.3|21.9|||Fisher Exact|||||21.9|8.3|0.0003
91741699|NCT04503551|183376448|SUPERIORITY||Stratified Hazard Ratio|0.1|||<|0.0001|TWO_SIDED|95.04|0.1|0.2|||Stratified Log-Rank||||A stratified log-rank test was used for hypothesis testing comparing the PDS arm with the comparator arm. A Cox proportional hazards regression model (stratified) was used as a supportive analysis to estimate the HR.|0.2|0.1|<0.0001
91741700|NCT01152788|183376501|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Log Rank|||||2.01|0.6|0.76
91741701|NCT01152788|183376502|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-18.7|16.8||||||||16.8|-18.7|
91741702|NCT01152788|183376503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.55|TWO_SIDED|95.0|0.38|1.68|||Log Rank|||||1.68|0.38|0.55
91741703|NCT01152788|183376504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Chi-squared|||||||0.01
91741704|NCT00778336|183376505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
91741705|NCT00778336|183376505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
91741706|NCT00778336|183376505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
91741707|NCT00778336|183376505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
91741708|NCT04585269|183376508|SUPERIORITY|Testing for a difference between arms|Mean Difference (Final Values)|-3.23|||<|0.001|TWO_SIDED|95.0|-4.93|-1.53|||Mixed Models Analysis|||||-1.53|-4.93|<0.001
91741709|NCT04585269|183376509|SUPERIORITY|Testing for a difference between arms|Mean Difference (Final Values)|-2.43||||0.003|TWO_SIDED|95.0|-4.05|-0.81|||Mixed Models Analysis|||||-0.81|-4.05|0.003
91741710|NCT04585269|183376510|SUPERIORITY|Testing for a difference between arms|Mean Difference (Final Values)|3.4||||0.029|TWO_SIDED|95.0|0.34|6.45|||Mixed Models Analysis|||||6.45|0.34|0.029
91741711|NCT01166347|183376566|NON_INFERIORITY|The non-inferiority margin was 15%.|Difference in Percentages|3.7||||0.011|ONE_SIDED|95.0||12.56|||Wald test||Difference = Control - HeartWare|Primary endpoint is 2 year survival free from disabling stroke (Modified Rankin Scale \>=4), death, exchange, explant due to device malfunction or urgent transplantation. Subjects who are electively transplanted or explanted due to recovery (no disabling stroke) must survive to 2 years post original implant to be considered a success.||12.56||0.0110
91499921|NCT01500629|182869734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.666|TWO_SIDED|95.0|-0.28|0.18|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.18|-0.28|0.666
91741712|NCT01166347|183376567|SUPERIORITY||Difference in Percentages|1.1||||0.5922|TWO_SIDED|95.0|-8.5|10.8||If p\<0.05, then the test is statistically significant.|Regression, Logistic|Treatment as the only independent variable.|Difference = HeartWare - Control|If non-inferiority is established for the primary endpoint, statistical testing for superiority and p-value estimation for the 3 secondary endpoints (incidence of bleeding, incidence of major infection, overall survival) will be performed in a pre-specified sequence and testing will continue at the nominal alpha level until the first non-significant result. This fixed sequence procedure strongly controls the family-wise error rate for the collection of the 3 secondary endpoints.||10.8|-8.5|0.5922
91741713|NCT03541499|183376597|SUPERIORITY|||||||0.807|||||||Barnard's exact test|||At any time point||||0.807
91741714|NCT03541499|183376597|SUPERIORITY|||||||0.043|||||||Barnard's exact test|||At any time point||||0.043
91741715|NCT03541499|183376598|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
91741716|NCT03541499|183376598|SUPERIORITY|||||||0.301|||||||Barnard's exact test|||Any time point||||0.301
91741717|NCT03541499|183376599|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
91741718|NCT03541499|183376599|SUPERIORITY|||||||0.009|||||||Barnard's exact test|||Any time point||||0.009
91741719|NCT03541499|183376601|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgA, any time point||||0.526
91741720|NCT03541499|183376601|SUPERIORITY|||||||0.1|||||||Barnard's exact test|||IgA, any time point||||0.100
91741721|NCT03541499|183376601|SUPERIORITY|||||||0.055|||||||Barnard's exact test|||IgG, any time point||||0.055
91741722|NCT03541499|183376601|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
91741723|NCT03541499|183376602|SUPERIORITY|||||||0.174|||||||Barnard's exact test|||IgA, any time point||||0.174
91741724|NCT03541499|183376602|SUPERIORITY|||||||0.006|||||||Barnard's exact test|||IgA, any time point||||0.006
91741725|NCT03541499|183376602|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||IgG, any time point||||0.745
91741726|NCT03541499|183376602|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
91741727|NCT03541499|183376608|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgA, any time point||||0.023
91741728|NCT03541499|183376608|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgA, any time point||||0.142
91741729|NCT03541499|183376608|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
91499922|NCT01500629|182869735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.972|TWO_SIDED|95.0|-0.29|0.28|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.28|-0.29|0.972
91499923|NCT01500629|182869736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.521|TWO_SIDED|95.0|-0.31|0.59|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.59|-0.31|0.521
91499924|NCT01500629|182869737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.376|TWO_SIDED|95.0|-0.15|0.39|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.39|-0.15|0.376
91499925|NCT01500629|182869738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.30|-0.11|0.350
91499926|NCT01500629|182869739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.36|0.34|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.34|-0.36|0.947
91499927|NCT01500629|182869740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.651|TWO_SIDED|95.0|-0.3|0.19|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.19|-0.30|0.651
91499928|NCT01500629|182869745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.261|TWO_SIDED|95.0|-1.3|0.38|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.38|-1.30|0.261
91741730|NCT03541499|183376608|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgG, any time point||||0.142
91741731|NCT03541499|183376609|SUPERIORITY|||||||0.836|||||||Barnard's exact test|||IgA, any time point||||0.836
91741732|NCT03541499|183376609|SUPERIORITY|||||||1|||||||Barnard's exact test|||IgA, any time point||||1.000
91499929|NCT01500629|182869746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.481|TWO_SIDED|95.0|-0.51|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.51|0.481
91741733|NCT03541499|183376609|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
91741734|NCT03541499|183376609|SUPERIORITY|||||||0.119|||||||Barnard's exact test|||IgG, any time point||||0.119
91499930|NCT01500629|182869747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.961|TWO_SIDED|95.0|-0.85|0.89|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.89|-0.85|0.961
91535607|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|1.79||0.398|TWO_SIDED|95.0|-5.06|2.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.02|-5.06|0.3980
91741735|NCT03541499|183376610|SUPERIORITY|||||||0.271|||||||Barnard's exact test|||Any time point||||0.271
91741736|NCT03541499|183376610|SUPERIORITY|||||||0.226|||||||Barnard's exact test|||Any time point||||0.226
91741737|NCT03541499|183376611|SUPERIORITY|||||||0.783|||||||Barnard's exact test|||Any time point||||0.783
91741738|NCT03541499|183376611|SUPERIORITY|||||||0.001|||||||Barnard's exact test|||Any time point||||0.001
91741739|NCT03541499|183376612|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||Any time point||||0.745
91741740|NCT03541499|183376612|SUPERIORITY|||||||0.068|||||||Barnard's exact test|||Any time point||||0.068
91741741|NCT03541499|183376613|SUPERIORITY|||||||0.585|||||||Barnard's exact test|||Any time point||||0.585
91741742|NCT03541499|183376613|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
91741743|NCT03533660|183376619|SUPERIORITY||||||<|0.05||||||Applies to SOCRATES subscales recognition, ambivalence, taking steps at 6 weeks|t-test, 2 sided|||||||<.05
91741744|NCT03533660|183376619|SUPERIORITY||||||>|0.05||||||Applies to SOCRATES total scores and subscales (recognition, ambivalence, and taking steps) at intake and 3 months|t-test, 2 sided|||||||>.05
91499931|NCT01500629|182869748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.546|TWO_SIDED|95.0|-0.57|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.57|0.546
91741745|NCT03533660|183376620|SUPERIORITY||||||>|0.05||||||Applies to alcohol self-efficacy scale total score and subscales scores at intake, 6 weeks and 3 months|t-test, 2 sided|||||||>.05
91741746|NCT04446312|183376635|NON_INFERIORITY|The pre-defined non-inferiority margin was 10%.|Risk Difference (RD)|0.15|||<|0.001|TWO_SIDED|95.0|-3.97|4.27|||Mantel Haenszel|||||4.27|-3.97|<0.001
91741747|NCT01682356|183376676|SUPERIORITY|||||||0.0153|||||||t-test, 2 sided|Paired||||||0.0153
91741748|NCT01682356|183376677|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|Paired||||||0.0131
91741749|NCT01682356|183376678|SUPERIORITY|||||||0.83||||||P value adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.83
91741750|NCT01682356|183376679|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 6.06 x 10\^-18.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
91741751|NCT01682356|183376680|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 1.87 x 10\^-20.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
91741752|NCT01682356|183376681|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 8.23 x 10\^-21.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
91741753|NCT01682356|183376682|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
91741754|NCT01682356|183376683|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
91741755|NCT01682356|183376684|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
91741756|NCT01682356|183376685|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
91499932|NCT02902965|182869749|OTHER||median PFS|8.5|||||TWO_SIDED|95.0|6.2|10.8|||||Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||10.8|6.2|
91499933|NCT02902965|182869750|OTHER||ORR in %|56.8|||||TWO_SIDED|95.0|44.7|68.2|||||Overall response = confirmed sCR + CR + VGPR + PR with corresponding 95% Exact binomial Cl|||68.2|44.7|
91741757|NCT01682356|183376686|SUPERIORITY|||||||0.3042||||||P value adjusted for multiplicity|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3042
91741758|NCT01682356|183376687|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 3.469 x 10\^-7.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
91741759|NCT01682356|183376688|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 7.202 x 10\^-8|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
91741760|NCT01682356|183376689|SUPERIORITY|||||||2.13e-06||||||P value adjusted for multiplicity. Exact P value 2.129 x 10\^-6.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.00000213
91741761|NCT01682356|183376690|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
91741762|NCT01682356|183376691|SUPERIORITY|||||||0.0598||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.05980
91741763|NCT01682356|183376692|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
91741764|NCT01682356|183376693|SUPERIORITY|||||||0.0987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.09870
91741765|NCT01682356|183376694|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
91741766|NCT01682356|183376695|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
91741767|NCT01682356|183376696|SUPERIORITY|||||||0.8819||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8819
91741768|NCT01682356|183376697|SUPERIORITY|||||||0.8987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8987
91741769|NCT03419897|183376758|SUPERIORITY|||||||0.0001|||||||Binomial exact test|||Tislelizumab compared with historical ORR rate of 7%||||0.0001
91741770|NCT05112679|183376775|OTHER|See SAP|Mean Difference (Final Values)|0.007|STANDARD_DEVIATION|0.21||0.009|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||All participants were randomized to both groups in a cross over design, if a participant started with proprio after 4 weeks of use they will cross over to Empower ankle or vice versa. the data reflect comparison of the groups.||||0.009
91741771|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior frontal gyrus||||<0.05
91741772|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Desire to void: L superior temporal gyrus||||<0.05
91741773|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior temporal gyrus||||<0.05
91741774|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle temporal gyrus||||<0.05
91741775|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle temporal gyrus||||<0.05
91741776|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior parietal lobule||||<0.05
91741777|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R inferior parietal lobule||||<0.05
91741778|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R paracentral lobule||||<0.05
91741779|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R superior parietal lobule||||<0.05
91741780|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supplementary motor area||||<0.05
91741781|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L postcentral gyrus||||<0.05
91741782|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R postcentral gyrus||||<0.05
91741783|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L angular gyrus||||<0.05
91741784|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supramarginal gyrus||||<0.05
91741785|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior medial gyrus||||<0.05
91741786|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior occipital gyrus||||<0.05
91741787|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle cingulate cortex||||<0.05
91741788|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle cingulate cortex||||<0.05
91741789|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R posterior cingulate cortex||||<0.05
91741790|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L thalamus||||<0.05
91741791|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R thalamus||||<0.05
91741792|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precuneus||||<0.05
91741793|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precuneus||||<0.05
91741794|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L caudate nucleus||||<0.05
91741795|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire void: L hippocampus||||<0.05
91741796|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L hippocampus||||<0.05
91741797|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L putamen||||<0.05
91741798|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precentral gyrus||||<0.05
91741799|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precentral gyrus||||<0.05
91741800|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L insula lobe||||<0.05
91741801|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior frontal gyrus||||<0.05
91741802|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle frontal gyrus||||<0.05
91741803|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R cerebellum||||<0.05
91741804|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R fusiform gyrus||||<0.05
91741805|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L postcentral gyrus||||<0.05
91741806|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R postcentral gyrus||||<0.05
91741807|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precentral gyrus||||<0.05
91741808|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precentral gyrus||||<0.05
91741809|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior temporal gyrus||||<0.05
91741810|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior temporal gyrus||||<0.05
91741811|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle temporal gyrus||||<0.05
91741812|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle temporal gyrus||||<0.05
91741813|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior temporal gyrus||||<0.05
91741814|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supramarginal gyrus||||<0.05
91499934|NCT02902965|182869751|OTHER||PFS rate|6.6|||||TWO_SIDED|95.0|1.6|16.9|||||Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||16.9|1.6|
91741815|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R supramarginal gyrus||||<0.05
91741816|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: L inferior occipital gyrus||||<0.05
91741817|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior occipital gyrus||||<0.05
91741818|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: R middle occipital gyrus||||<0.05
91741819|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Orbitalis)||||<0.05
91741820|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Triangularis)||||<0.05
91741821|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Opercularis)||||<0.05
91741822|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Orbitalis)||||<0.05
91741823|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Triangularis)||||<0.05
91499935|NCT02902965|182869754|OTHER||median TTP|10.6|||||TWO_SIDED|95.0|7.8|12.0|||||KM estimates for median TTP with associated 95% CI|||12|7.8|
91499936|NCT02259582|182869773|SUPERIORITY|Based on RECIST v1.1. Response outcomes from an assessment done anytime less than Day 35 were considered as not evaluable unless the response assessment was progress disease.|Hazard Ratio (HR)|0.04|||=|0.0401|TWO_SIDED|95.0|0.013|0.095|||Log Rank|||The Kaplan-Meier method was used to estimate both the survival curves and the median survival time. The 95% confidence interval (CI) for the median survival time was calculated. A p-value for treatment effect was generated using a stratified Cox proportional hazards model.||.095|.013|=0.0401
91499937|NCT01969240|182869775|SUPERIORITY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.46|0.86||||||||0.86|0.46|
91741824|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L cerebellum||||<0.05
91741825|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rectal gyrus||||<0.05
91741826|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rectal gyrus||||<0.05
91741827|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior medial gyrus||||<0.05
91741828|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior medial gyrus||||<0.05
91741829|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior frontal gyrus||||<0.05
91741830|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior frontal gyrus||||<0.05
91741831|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle frontal gyrus||||<0.05
91741832|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle frontal gyrus||||<0.05
91741833|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supplementary motor area (SMA)||||<0.05
91741834|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R SMA||||<0.05
91741835|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L paracentral lobule||||<0.05
91741836|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R paracentral lobule||||<0.05
91741837|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior parietal lobule||||<0.05
91741838|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior parietal lobule||||<0.05
91741839|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior orbital gyrus||||<0.05
91741840|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle orbital gyrus||||<0.05
91499938|NCT01969240|182869776|SUPERIORITY||||||<|0.013|||||||t-test, 2 sided|The a-priori significance level was 0.05.||||||<0.013
91741841|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle orbital gyrus||||<0.05
91741842|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R calcarine gyrus||||<0.05
91741843|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L calcarine gyrus||||<0.05
91499939|NCT01969240|182869777|SUPERIORITY||Mean Difference (Final Values)|10.3|||||TWO_SIDED|95.0|9.1|11.5||||||||11.5|9.1|
91499940|NCT01969240|182869778|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
91499941|NCT01969240|182869779|SUPERIORITY||||||<|0.001|||||||negative binomial model|||||||<0.001
91499942|NCT01969240|182869780|SUPERIORITY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.8|-0.9||||||||-0.90|-4.8|
91741844|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L anterior cingulate cortex||||<0.05
91741845|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle cingulate cortex||||<0.05
91741846|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle cingulate cortex||||<0.05
91741847|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R angular gyrus||||<0.05
91741848|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L thalamus||||<0.05
91499943|NCT01969240|182869781|SUPERIORITY||Median Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-0.2|3.6||||||||3.6|-0.2|
91741849|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R thalamus||||<0.05
91741850|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precuneus||||<0.05
91741851|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precuneus||||<0.05
91741852|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R caudate nucleus||||<0.05
91513594|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-3.2|-0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.8|-3.2|< 0.001
91741853|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L putamen||||<0.05
91741854|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L amygdala||||<0.05
91741855|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R insula lobe||||<0.05
91741856|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rolandic operculum||||<0.05
91741857|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L hippocampus||||<0.05
91741858|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R hippocampus||||<0.05
91741859|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R fusiform gyrus||||<0.05
91741860|NCT03574610|183376798|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rolandic operculum||||<0.05
91741861|NCT03574610|183376799|OTHER|||||||0.45||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Voided volume - baseline vs post-treatment||||0.45
91741862|NCT03574610|183376799|OTHER|||||||0.39||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Voided volume - baseline vs 4 month follow-up||||0.39
91741863|NCT03574610|183376799|OTHER|||||||0.014||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||PVR - baseline vs post-treatment||||0.014
91741864|NCT03574610|183376799|OTHER|||||||0.66||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||PVR - baseline vs 4 month follow-up||||0.66
91741865|NCT03574610|183376799|OTHER|||||||0.31||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Bladder capacity - baseline vs post-treatment||||0.31
91499944|NCT00412854|182869809|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.61|||||TWO_SIDED|95.0|-1.68|3.39||||||"Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course."||3.39|-1.68|
91741866|NCT03574610|183376799|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Bladder capacity - baseline vs 4 month follow-up||||0.001
91741867|NCT03574610|183376800|OTHER|||||||0.004||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||% PVR/BC - baseline vs post-treatment||||0.004
91741868|NCT03574610|183376800|OTHER|||||||0.038||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||%PVR/BC - baseline vs 4 month follow-up||||0.038
91741869|NCT03574610|183376801|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Qmax - baseline vs post-treatment||||0.19
91741870|NCT03574610|183376801|OTHER|||||||0.91||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Max - baseline vs 4 month follow-up||||0.91
91741871|NCT03574610|183376802|OTHER|||||||0.13||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Liverpool nomogram percentile - baseline vs post-treatment||||0.13
91741872|NCT03574610|183376802|OTHER|||||||0.26||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Liverpool nomogram percentile - baseline vs 4 month follow-up||||0.26
91741873|NCT03574610|183376803|OTHER|||||||0.4||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q1 - baseline vs post-treatment||||0.40
91741874|NCT03574610|183376803|OTHER|||||||0.086||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q1 - baseline vs 4 month follow-up||||0.086
91741875|NCT03574610|183376803|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test.||UDI-6 Q2 - baseline vs post-treatment||||0.54
91741876|NCT03574610|183376803|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q2 - baseline vs 4 month follow-up||||0.19
91741877|NCT03574610|183376803|OTHER|||||||0.04||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q5 - baseline vs post-treatment||||0.04
91741878|NCT03574610|183376803|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 5 - baseline vs 4 month follow-up||||0.026
91741879|NCT03574610|183376804|OTHER|||||||0.044||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q3 - baseline vs post-treatment||||0.044
91741880|NCT03574610|183376804|OTHER|||||||0.017||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q3 - baseline vs 4 month follow-up||||0.017
91741881|NCT03574610|183376804|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q5 - baseline vs post-treatment||||0.54
91741882|NCT03574610|183376804|OTHER|||||||0.503||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q5 - baseline vs 4 month follow-up||||0.503
91741883|NCT03574610|183376804|OTHER|||||||0.023||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q7 - baseline vs post-treatment||||0.023
91741884|NCT03574610|183376804|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q7 - baseline vs 4 month follow-up||||0.049
91741885|NCT03574610|183376804|OTHER|||||||0.089||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q8 - baseline vs post-treatment||||0.089
91741886|NCT03574610|183376804|OTHER|||||||0.161||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q8 - baseline vs 4 month follow-up||||0.161
91741887|NCT03574610|183376805|OTHER|||||||0.01||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Incontinence) - baseline vs post-treatment||||0.010
91741888|NCT03574610|183376805|OTHER|||||||0.41||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Incontinence) - baseline vs 4 month follow-up||||0.41
91741889|NCT03574610|183376805|OTHER|||||||0.32||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Storage and Voiding) - baseline vs post-treatment||||0.32
91741890|NCT03574610|183376805|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Storage and Voiding) - baseline vs 4 month follow-up||||0.02
91741891|NCT03574610|183376805|OTHER|||||||0.34||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Consequences) - baseline vs post-treatment||||0.34
91499945|NCT00412854|182869809|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
91513595|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.1|-0.4||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.4|-2.1|< 0.001
91741892|NCT03574610|183376805|OTHER|||||||0.61||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Consequences) - baseline vs 4 month follow-up||||0.61
91741893|NCT03574610|183376805|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs post-treatment||||0.02
91741894|NCT03574610|183376805|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs 4 month follow-up||||0.07
91741895|NCT00958360|183376890|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91741896|NCT00958360|183376891|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
91741897|NCT00958360|183376892|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91741898|NCT00958360|183376893|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
91741899|NCT00958360|183376894|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
91741900|NCT02263326|183376899|NON_INFERIORITY|We considered DTG/3TC was noninferior to cART if the 90% confidence interval for the difference in proportions, calculated with Miettinen-Nurminen (score) confidence limits, excluded the 12% noninferiority margin.|Risk Difference (RD)|0.0015|||||TWO_SIDED|90.0|-0.098|0.102||||||A sample size of 41 participants per arm provided 80% power to show noninferiority of DTG/3TC to cART based on a 12% noninferiority margin, assuming an estimated treatment failure rate of 5% per arm by week 24 and 5% 1-sided type I error rate.||0.102|-0.098|
91741901|NCT02263326|183376900|NON_INFERIORITY|The difference in virologic outcomes based on the FDA snapshot algorithm at week 48 (HIV RNA \<50 copies/mL) was compared between arms, with 95% confidence intervals.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.126|0.165||||||||0.165|-0.126|
91741902|NCT02263326|183376901|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
91741903|NCT02263326|183376902|OTHER|||||||0.613|||||||Wilcoxon (Mann-Whitney)|||||||0.613
91741904|NCT02263326|183376903|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
91741905|NCT02263326|183376904|OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
91741906|NCT02263326|183376906|OTHER||Mean Difference (Final Values)|0.5||||0.76|TWO_SIDED|95.0|-3.0|4.1|||Regression, Linear|||||4.1|-3.0|0.76
91741907|NCT01061723|183376907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.966|TWO_SIDED|95.0|0.4|2.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||Sarilumab group was compared to placebo group. Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived.||2.5|0.4|0.966
91741908|NCT01061723|183376907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.467|TWO_SIDED|95.0|0.6|3.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.5|0.6|0.467
91741909|NCT01061723|183376907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.559|TWO_SIDED|95.0|0.3|1.9||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||1.9|0.3|0.559
91741910|NCT01061723|183376907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.496|TWO_SIDED|95.0|0.6|3.4||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.4|0.6|0.496
91741911|NCT01061723|183376907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.143|TWO_SIDED|95.0|0.8|4.2||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||4.2|0.8|0.143
91741912|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.56|||||Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus \[-\] Vax 1).|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.56|0.28|
91741913|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.67|
91741914|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.44|0.72|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.72|0.44|
91760123|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.43|0.56||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.43|
91499946|NCT00412854|182869810|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|2.47|||||TWO_SIDED|95.0|0.15|6.18||||||"Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||6.18|0.15|
91499947|NCT00412854|182869811|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
91499948|NCT00412854|182869811|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
91499949|NCT00412854|182869811|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|1.23|||||TWO_SIDED|95.0|-2.17|5.07||||||"Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||5.07|-2.17|
91499950|NCT00708643|182869854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0047|STANDARD_ERROR_OF_MEAN|2.2863|||TWO_SIDED|98.75|-3.0047|2.7153|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.||2.7153|-3.0047|
91499951|NCT00708643|182869855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0804|STANDARD_ERROR_OF_MEAN|0.7605|||TWO_SIDED|99.0|-0.0804|1.8821|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.||1.8821|-0.0804|
91499952|NCT00708643|182869856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2228|STANDARD_ERROR_OF_MEAN|1.7002|||TWO_SIDED|99.0|0.2228|4.6564|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.||4.6564|0.2228|
91499953|NCT00708643|182869857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2596|STANDARD_ERROR_OF_MEAN|1.1873|||TWO_SIDED|98.75|1.2596|4.2599|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|||4.2599|1.2596|
91705215|NCT03053427|183304949|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.088|TWO_SIDED|95.0|-2.6|0.2|||Mixed Model of Repeated Measurements|||MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.||0.2|-2.6|0.088
91705216|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.051|TWO_SIDED|95.0|-2.2|0.0|||ANCOVA|Time frame: week 1||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.0|-2.2|0.051
91705217|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.02|TWO_SIDED|95.0|-2.8|-0.2|||ANCOVA|Time frame: week 2||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.8|0.020
91705218|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.028|TWO_SIDED|95.0|-2.9|-0.2|||ANCOVA|Time frame: week 4||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.9|0.028
91741915|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.53|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.53|0.32|
91741916|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.45|0.91|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.91|0.45|
91741917|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.56|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.56|
91499954|NCT00708643|182869858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8625|STANDARD_ERROR_OF_MEAN|2.3407|||TWO_SIDED|98.75|-0.8625|5.0524|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.||5.0524|-0.8625|
91741918|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.25|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.25|
91741919|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.16|0.4|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.40|0.16|
91741920|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.4|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.78|0.40|
91741921|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.40|
91499955|NCT00708643|182869859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|1.6975|||TWO_SIDED|98.75|-0.241|4.0043|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.||4.0043|-0.2410|
91499956|NCT02493608|182869925|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91499957|NCT02493608|182869926|OTHER|||||||0.218||||||POD 1|t-test, 2 sided|||||||0.218
91741922|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.48|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.48|0.30|
91741923|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.67|0.35|
91741924|NCT00500357|183376919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.86|1.86|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.86|0.86|
91741925|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.57|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.57|0.34|
91741926|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.95|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.95|0.66|
91741927|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.76|1.22|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.22|0.76|
91741928|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.8|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.80|0.57|
91741929|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.39|2.84|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||2.84|1.39|
91741930|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.11|1.63|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.63|1.11|
91741931|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.18|0.41|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.41|0.18|
91499958|NCT02493608|182869926|OTHER|||||||0.638||||||POD 2|t-test, 2 sided|||||||0.638
91499959|NCT02493608|182869927|OTHER|||||||0.113|||||||t-test, 2 sided|||||||0.113
91499960|NCT03045887|182869967|OTHER||Ratio|0.41|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.27|0.61|||||AUC(0-t). Standard error of mean was on logged scale|||0.61|0.27|
91499961|NCT03045887|182869967|OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.65|1.47|||||AUC(0-t).Standard error of mean was on logged scale|||1.47|0.65|
91741932|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.27|
91741933|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.83|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.83|0.57|
91741934|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|1.03|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.03|0.66|
91741935|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.58|
91741936|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.73|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.73|0.47|
91741937|NCT00500357|183376922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.94|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.94|1.18|
91741938|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.65|||||TWO_SIDED|95.0|0.52|0.82|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.82|0.52|
91741939|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.52|||||TWO_SIDED|95.0|0.43|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.62|0.43|
91741940|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.63|||||TWO_SIDED|95.0|0.53|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.76|0.53|
91741941|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.32|||||TWO_SIDED|95.0|0.27|0.39|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.39|0.27|
91741942|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.10|0.74|
91741943|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.99|0.63|
91705219|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.043|TWO_SIDED|95.0|-2.9|0.0|||ANCOVA|Time frame: week 6||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.0|-2.9|0.043
91741944|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.72|||||TWO_SIDED|95.0|0.6|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.87|0.60|
91741945|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.6|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.60|0.42|
91741946|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.59|0.98|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.98|0.59|
91741947|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.38|||||TWO_SIDED|95.0|0.31|0.46|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.46|0.31|
91741948|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.74|0.49|
91741949|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.79|0.52|
91741950|NCT00500357|183376923|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.93|0.62|
91741951|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.6|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.60|
91741952|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.64|0.48|
91705220|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.184|TWO_SIDED|95.0|-2.4|0.5|||ANCOVA|Time frame: week 8||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.5|-2.4|0.184
91705221|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.027|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|Time frame: week 10||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-3.1|0.027
91705222|NCT03053427|183304950|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.087|TWO_SIDED|95.0|-3.0|0.2|||ANCOVA|Time frame: week 12||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.2|-3.0|0.087
91705223|NCT03053427|183304950|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.312|TWO_SIDED|95.0|-2.4|0.8|||ANCOVA|Time frame: EoT||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.8|-2.4|0.312
91705224|NCT03053427|183304951|SUPERIORITY||difference|4.2||||0.467|TWO_SIDED|95.0|-6.4|14.8|||Fisher Exact|||||14.8|-6.4|0.467
91705225|NCT03053427|183304952|SUPERIORITY||difference|5.8||||0.3|TWO_SIDED|95.0|-4.8|16.5|||Fisher Exact|||||16.5|-4.8|0.300
91705226|NCT03053427|183304953|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.877|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.5|-0.5|0.877
91705227|NCT03053427|183304954|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.975|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.7|-0.7|0.975
91705228|NCT03053427|183304955|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.838|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.3|-0.4|0.838
91705229|NCT01801241|183304961|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
91705230|NCT02607306|183304968|NON_INFERIORITY|Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for non-inferiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
91499962|NCT03045887|182869967|OTHER||Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|1.01|1.74|||||AUC(0-t).Standard error of mean was on logged scale|||1.74|1.01|
91741953|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.75|||||TWO_SIDED|95.0|0.65|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.87|0.65|
91741954|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.61|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.76|0.61|
91741955|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.49|||||TWO_SIDED|95.0|1.27|1.75|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.75|1.27|
91741956|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.07|||||TWO_SIDED|95.0|0.94|1.21|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.21|0.94|
91741957|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.58|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.79|0.58|
91741958|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.53|
91741959|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.59|||||TWO_SIDED|95.0|0.51|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.67|0.51|
91741960|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.67|||||TWO_SIDED|95.0|0.6|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.74|0.60|
91741961|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.78|||||TWO_SIDED|95.0|0.69|0.88|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.88|0.69|
91741962|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.54|||||TWO_SIDED|95.0|0.47|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.62|0.47|
91741963|NCT00500357|183376924|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.06|||||TWO_SIDED|95.0|0.9|1.25|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.25|0.90|
91741964|NCT03292874|183376926|SUPERIORITY|||||||0.014||||||"Areas under the receiver operating characteristics curve (AUC) were compared between models with standard and high-resolution MRI variables using the nonparametric method described by DeLong.~DeLong. Biometrics 1988;44(3):837-45."|nonparametric method|||||||0.014
91499963|NCT03045887|182869967|OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|0.69|1.62|||||AUC(0-t).Standard error of mean was on logged scale|||1.62|0.69|
91741965|NCT02482298|183376927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.06367|||TWO_SIDED|90.0|-0.061|0.151|||Mixed Models Analysis|||||0.1510|-0.0610|
91741966|NCT02482298|183376927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0801|STANDARD_ERROR_OF_MEAN|0.06192|||TWO_SIDED|90.0|-0.023|0.1832|||Mixed Models Analysis|||||0.1832|-0.0230|
91741967|NCT02482298|183376929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1192|STANDARD_ERROR_OF_MEAN|0.05059|||TWO_SIDED|90.0|0.035|0.2035|||Mixed Models Analysis|||||0.2035|0.0350|
91741968|NCT02482298|183376929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0975|STANDARD_ERROR_OF_MEAN|0.04923|||TWO_SIDED|90.0|0.0155|0.1795|||Mixed Models Analysis|||||0.1795|0.0155|
91499964|NCT03045887|182869967|OTHER||Ratio|1.25|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|0.95|1.64|||||AUC(0-t).Standard error of mean was on logged scale|||1.64|0.95|
91499965|NCT03045887|182869968|OTHER||Ratio|1.22|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|90.0|1.01|1.47|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented|||1.47|1.01|
91499966|NCT03045887|182869969|OTHER||ratio|0.78|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.61|0.99||||||||0.99|0.61|
91741969|NCT00348946|183376970|SUPERIORITY|BOT Visual-motor control||||||0.005|||||||ANCOVA|||||||0.005
91741970|NCT00348946|183376970|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT upper limb speed||||0.17
91741971|NCT00348946|183376970|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT strength||||0.17
91741972|NCT00348946|183376970|SUPERIORITY|||||||0.06|||||||ANCOVA|||Hand dynamometer||||0.06
91741973|NCT00348946|183376970|SUPERIORITY|||||||0.87|||||||ANCOVA|||PANESS||||0.87
91741974|NCT00348946|183376971|SUPERIORITY|||||||0.44|||||||ANCOVA|||DAS: General concept ability||||0.44
91741975|NCT00348946|183376971|SUPERIORITY|||||||0.57|||||||ANCOVA|||DAS: Verbal Cluster||||0.57
91741976|NCT00348946|183376971|SUPERIORITY|||||||0.55|||||||ANCOVA|||DAS: Nonverbal Cluster||||0.55
91741977|NCT00348946|183376971|SUPERIORITY|||||||0.65|||||||ANCOVA|||DAS: Spatial Cluster||||0.65
91741978|NCT00348946|183376972|SUPERIORITY|||||||0.23|||||||ANCOVA|||Digit Span backward||||0.23
91741979|NCT00348946|183376972|SUPERIORITY|||||||0.36|||||||ANCOVA|||Phonetic fluency||||0.36
91741980|NCT00348946|183376972|SUPERIORITY|||||||0.37|||||||ANCOVA|||Semantic fluency||||0.37
91741981|NCT00348946|183376972|SUPERIORITY|||||||0.41|||||||ANCOVA|||CPT: omissions||||0.41
91741982|NCT00348946|183376972|SUPERIORITY|||||||0.73|||||||ANCOVA|||CPT: commissions||||0.73
91741983|NCT00348946|183376972|SUPERIORITY|||||||0.4|||||||ANCOVA|||CPT: hit reaction time||||0.40
91741984|NCT00348946|183376972|SUPERIORITY|||||||0.95|||||||ANCOVA|||CPT: variability||||0.95
91741985|NCT00348946|183376972|SUPERIORITY|||||||0.78|||||||ANCOVA|||CPT: preservations||||0.78
91741986|NCT00348946|183376973|SUPERIORITY|||||||0.16|||||||ANCOVA|||CBCL: Behavior total||||0.16
91741987|NCT00348946|183376973|SUPERIORITY|||||||0.1|||||||ANCOVA|||CBCL: Internalizing total||||0.10
91741988|NCT00348946|183376973|SUPERIORITY|||||||0.24|||||||ANCOVA|||CBCL: externalizing total||||0.24
91741989|NCT00348946|183376973|SUPERIORITY|||||||0.5|||||||ANCOVA|||CDI: Total||||0.50
91741990|NCT00348946|183376974|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
91741991|NCT03332173|183376982|SUPERIORITY||||||<|0.0001||||||P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)|Exact binomial test|||Zanubrutinib versus historical control estimate of 30%||||<0.0001
91741992|NCT00131352|183377013|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.||||||0.047
91741993|NCT00131352|183377014|SUPERIORITY_OR_OTHER|||||||0.064||95.0|||||ANCOVA|||||||0.064
91741994|NCT00131352|183377015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.022|TWO_SIDED|95.0|0.35|0.92|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.||0.92|0.35|0.022
91499967|NCT03045887|182869969|OTHER||ratio|0.96|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.75|1.22||||||||1.22|0.75|
91499968|NCT03045887|182869969|OTHER||ratio|0.81|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.68|0.97||||||||0.97|0.68|
91499969|NCT03045887|182869969|OTHER||ratio|0.66|STANDARD_ERROR_OF_MEAN|0.154|||TWO_SIDED|90.0|0.51|0.86||||||||0.86|0.51|
91499970|NCT03045887|182869969|OTHER||ratio|0.76|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.63|0.9||||||||0.90|0.63|
91741995|NCT00131352|183377016|SUPERIORITY_OR_OTHER|||||||0.679||95.0|||||ANCOVA|||||||0.679
91741996|NCT00131352|183377017|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||||||0.266
91741997|NCT00131352|183377018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.005|TWO_SIDED|95.0|0.31|0.82|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.||0.82|0.31|0.005
91741998|NCT00131352|183377019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.025|TWO_SIDED|95.0|0.34|0.93|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.||0.93|0.34|0.025
91741999|NCT00131352|183377020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.156|TWO_SIDED|95.0|0.41|1.16|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.||1.16|0.41|0.156
91742000|NCT00910910|183377035|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.323|TWO_SIDED|90.0|0.88|1.66|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.66|0.88|0.323
91742001|NCT00910910|183377036|SUPERIORITY||Cox Proportional Hazard|0.99||||0.967|TWO_SIDED|90.0|0.76|1.29||The p-value is based on a stratified log-rank test|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.29|0.76|0.967
91742002|NCT00910910|183377039|SUPERIORITY||Odds Ratio (OR)|0.65||||0.032|TWO_SIDED|95.0|0.44|0.96|||Fisher Exact|||||0.96|0.44|0.032
91742003|NCT00910910|183377040|SUPERIORITY||Odds Ratio (OR)|0.66||||0.047|TWO_SIDED|95.0|0.45|0.98|||Fisher Exact|||||0.98|0.45|0.047
91742004|NCT00910910|183377041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.826|TWO_SIDED|90.0|0.58|1.52|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.52|0.58|0.826
91742005|NCT00910910|183377042|SUPERIORITY||Cox Proportional Hazard|0.71||||0.149|TWO_SIDED|90.0|0.48|1.05|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.05|0.48|0.149
91742006|NCT00910910|183377045|SUPERIORITY||Cox Proportional Hazard|1.03||||0.883|TWO_SIDED|90.0|0.73|1.46|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.46|0.73|0.883
91742007|NCT00910910|183377046|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||0.709|TWO_SIDED|90.0|0.83|1.34|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.34|0.83|0.709
91742008|NCT00383331|183377051|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||The response rates are separately evaluated for these two treatment arms. For each arm, a sample size of 48 achieves 91% power to detect a difference of 20% between the null hypothesis of 15% response rate and the alternative hypothesis of 35% using a one-sided, binomial hypothesis test with a target significance level of 2.5% (the actual significance level is 2.2%).||||0.48
91742009|NCT00383331|183377056|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Log Rank|||||||0.56
91742010|NCT01926444|183377152|OTHER|||||||0.506|||||||ANOVA|||AUC- censorsed (standardized); FAS||||0.506
91742011|NCT01926444|183377152|OTHER|||||||0.299|||||||ANOVA|||AUC LOCF (standardized); FAS||||0.299
91742012|NCT01926444|183377152|OTHER|||||||0.234|||||||ANOVA|||AUC Censored (Standardized)- PP Population||||0.234
91742013|NCT01926444|183377152|OTHER|||||||0.219|||||||ANOVA|||AUC LOCF (Standardized)- PP Population||||0.219
91742014|NCT01926444|183377153|OTHER|||||||0.047|||||||Chi-squared|||Time to Caecum||||0.047
91742015|NCT01926444|183377154|OTHER|||||||0.047|||||||Chi-squared|||||||0.047
91742016|NCT00894699|183377165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91742017|NCT00894699|183377165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91742018|NCT02626156|183377166|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.091|TWO_SIDED|95.0|-0.02|0.3|||Chi-squared||Asymptotic standard error was used|||0.3|-0.02|0.091
91742019|NCT05111613|183377458|SUPERIORITY||Win Ratio|5.01|||||TWO_SIDED|95.0|3.68|6.97||||||||6.97|3.68|
91742020|NCT05111613|183377459|SUPERIORITY||Win Ratio|1.34|||||TWO_SIDED|95.0|0.78|2.35||||||||2.35|0.78|
91742021|NCT04209387|183377478|OTHER|p \< .01||||||0.01||||||p adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||"Pair-wise comparison of changes in coherency from baseline (before therapy) to the end of therapy.~Pair-wise comparison of changes in coherency from end of therapy to 3-month follow-up"|ANOVA test of means|||0.01
91742022|NCT01392573|183377482|SUPERIORITY_OR_OTHER||Treatment contrast|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.84|||ANCOVA|ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate||||-0.84|-1.25|<0.0001
91742023|NCT03079531|183377488|OTHER|||||||0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there would be no difference in papule/pustule count at baseline and after 16 weeks of secukinumab; the alternative hypothesis is that there would be a difference. Using an alpha=0.05 and power=0.80 (two sided test), the sample size needed would be 20. Assuming a dropout rate of 20%, 24 patients would be needed to achieve sufficient sample size.||||0.01
91742024|NCT03079531|183377489|OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
91742025|NCT03079531|183377490|OTHER|||||||0.03|||||||Wilcoxon signed rank test|||||||0.03
91742026|NCT03079531|183377491|OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
91742027|NCT03079531|183377492|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91742028|NCT03079531|183377494|OTHER|||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
91742029|NCT00841412|183377507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|||<|0.05|TWO_SIDED|95.0|0.59|0.96|||Mixed Models Analysis||The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention.|||0.96|0.59|<0.05
91742030|NCT00325130|183377508|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742031|NCT00325130|183377510|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742032|NCT00325130|183377511|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742033|NCT00325130|183377512|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742034|NCT00325130|183377513|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742035|NCT00325130|183377514|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742036|NCT00325130|183377515|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742037|NCT00325130|183377516|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742038|NCT00325130|183377517|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742039|NCT00325130|183377518|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
91742040|NCT00325130|183377519|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91742041|NCT00325130|183377520|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91742042|NCT00325130|183377521|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91742043|NCT00325130|183377522|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91742044|NCT00325130|183377523|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91742045|NCT00325130|183377524|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91499971|NCT03045887|182869970|OTHER||ratio|1.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|0.96|1.36|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented|||1.36|0.96|
91742046|NCT00325130|183377525|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91742047|NCT00325130|183377526|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
91499972|NCT03045887|182869976|OTHER||Ratio|2.06|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|1.67|2.55|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.|||2.55|1.67|
91499973|NCT00680745|182869998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.0867|<|0.0001|TWO_SIDED|95.0|-0.61|-0.27||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.27|-0.61|<0.0001
91499974|NCT00680745|182869998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.0885|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.32|-0.67|<0.0001
91499975|NCT00680745|182869998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.0873|<|0.0001|TWO_SIDED|95.0|-0.86|-0.51||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.51|-0.86|<0.0001
91499976|NCT00680745|182869999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.3153||0.141|TWO_SIDED|95.0|-1.08|0.15||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.15|-1.08|0.1410
91499977|NCT00680745|182869999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3217||0.0091|TWO_SIDED|95.0|-1.47|-0.21||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.21|-1.47|0.0091
91742048|NCT03896750|183377527|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-last). Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.83|||||TWO_SIDED|90.0|0.54|1.26|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%.||1.26|0.54|
91742049|NCT03896750|183377527|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-last). Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.87|||||TWO_SIDED|90.0|0.67|1.14|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%||1.14|0.67|
91760124|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||||TWO_SIDED|95.0|0.37|1.41||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.41|0.37|
91499978|NCT00680745|182869999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.3168|<|0.0001|TWO_SIDED|95.0|-2.17|-0.92||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.92|-2.17|<0.0001
91499979|NCT00680745|182870000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|STANDARD_ERROR_OF_MEAN|6.874|||TWO_SIDED|95.0|-45.0|-18.0||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-18.0|-45.0|
91760125|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-0.15|0.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.89|-0.15|
91760126|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.61|0.42||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.61|
91499980|NCT00680745|182870000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|STANDARD_ERROR_OF_MEAN|6.968||0.0002|TWO_SIDED|95.0|-39.7|-12.3||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.3|-39.7|0.0002
91499981|NCT00680745|182870000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.9|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|-42.2|-15.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.6|-42.2|<0.0001
91499982|NCT00680745|182870001|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.7|STANDARD_ERROR_OF_MEAN|4.265|||TWO_SIDED|95.0|5.4|22.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||22.1|5.4|
91499983|NCT00680745|182870001|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3|STANDARD_ERROR_OF_MEAN|4.392||0.0001|TWO_SIDED|95.0|8.7|25.9||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||25.9|8.7|0.0001
91499984|NCT00680745|182870001|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|4.457|<|0.0001|TWO_SIDED|95.0|9.9|27.4||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||27.4|9.9|<0.0001
91499985|NCT00680745|182870002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.4159|||TWO_SIDED|95.0|-1.19|0.45||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.45|-1.19|
91499986|NCT00680745|182870002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.4234||0.0262|TWO_SIDED|95.0|-1.78|-0.11||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.11|-1.78|0.0262
91499987|NCT00680745|182870002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.4211|<|0.0001|TWO_SIDED|98.0|-2.5|-0.84||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.84|-2.50|<0.0001
91742050|NCT03896750|183377528|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-infinity). Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.87|||||TWO_SIDED|90.0|0.54|1.39|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%||1.39|0.54|
91742051|NCT03896750|183377528|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-infinity). Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.95|||||TWO_SIDED|90.0|0.71|1.28|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%||1.28|0.71|
91742052|NCT00932035|183377553|SUPERIORITY|To achieve a power of 0.84, a sample size of 72 patients, evenly distributed is required. With 36 patients per group, a Fisher's exact test with a one-sided alpha of 0.05 will have a 84% power to detect the difference between the experimental group (axillary reverse mapping) of 5% or less and a control group (standard dissection) of 30% or more. Response estimates were chosen based on reported lymphedema rates.||||||0.45|||||||Fisher Exact|||||||0.45
91742053|NCT00932035|183377554|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.50
91742054|NCT00932035|183377555|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
91499988|NCT00680745|182870003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|3.522|||TWO_SIDED|95.0|-21.8|-7.9||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-7.9|-21.8|
91499989|NCT00680745|182870003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|STANDARD_ERROR_OF_MEAN|3.594|<|0.0001|TWO_SIDED|95.0|-26.3|-12.2||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.2|-26.3|<0.0001
91742055|NCT02522429|183377646|OTHER|||||||0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7)|t-test, 1 sided|||||||0.05
91742056|NCT02522429|183377647|OTHER||||||<|0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7). All significant voxels have an associated p-value smaller-or-equal to 0.05 (corrected for multiplicity).|t-test, 1 sided|||||||<0.05
91499990|NCT00680745|182870003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|3.545|<|0.0001|TWO_SIDED|95.0|-33.5|-19.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-19.5|-33.5|<0.0001
91742057|NCT02522429|183377649|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Maximum CRS-R prior to LIFUP compared to Maximum CRS-R after LIFUP||||<0.05
91742058|NCT00294671|183377651|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 2 years.||||<0.001
91742059|NCT00294671|183377651|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 1years.||||0.02
91742060|NCT00294671|183377652|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 2 years.||||0.002
91742061|NCT00294671|183377652|SUPERIORITY_OR_OTHER|||||||0.1|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 1 year.||||0.10
91742062|NCT00294671|183377653|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 2 years.||||0.21
91742063|NCT00294671|183377653|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 1 year.||||0.43
91742064|NCT00294671|183377654|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 2 years.||||0.001
91742065|NCT00294671|183377654|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 1 year.||||0.06
91513596|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-3.2|2.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.7|-3.2|< 0.001
91742066|NCT00294671|183377655|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 2 years.||||0.06
91742067|NCT00294671|183377655|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 1 year.||||0.37
91742068|NCT03053440|183377684|SUPERIORITY||Risk Difference (RD)|10.2||||0.0921|TWO_SIDED|95.0|-1.5|22.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided||||22.0|-1.5|0.0921
91742069|NCT00473889|183377711|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Log Rank|Disease stage and bevacizumab eligibility are the stratification factors in the stratified log rank test.||||||0.992
91742070|NCT00473889|183377712|SUPERIORITY_OR_OTHER|||||||0.862||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Finkelstein's Interval Censored Method|Disease stage and bevacizumab eligibility are the stratification factors in the Finkelstein's Interval Censored Method Model.||||||0.862
91742071|NCT00473889|183377713|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Miettinen and Nurminen|Disease stage and bevacizumab eligibility are the stratification factors in the stratified Miettinen and Nurmimen method.||||||0.899
91742072|NCT00460655|183377727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.428||||0.006||95.0|-5.841|-1.016|||t-test, 2 sided|||||-1.016|-5.841|0.006
91742073|NCT03024112|183377770|OTHER|||||||0.68|||||||t-test, 1 sided|||||||0.680
91742074|NCT01399229|183377775|NON_INFERIORITY_OR_EQUIVALENCE|"Agreement between SureCALL® and Tocodynamometer Contraction Peak Times~Null hypothesis: The mean peak difference between RMS and TOCO is equal to 0. Alternative hypothesis: The mean peak difference is not equal to 0."|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|1.4086||0.4901|TWO_SIDED|95.0|-28.74|30.72|||Mixed Models Analysis|||||30.72|-28.74|0.4901
91742075|NCT02253433|183377776|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.575|TWO_SIDED|95.0|-0.87|2.07|||Mixed Models Analysis|||||2.07|-.87|0.575
91742076|NCT02253433|183377777|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.141|TWO_SIDED|95.0|-0.18|0.68|||Mixed Models Analysis|||||.68|-.18|0.141
91742077|NCT02253433|183377778|SUPERIORITY||Odds Ratio (OR)|0.86||||0.043|TWO_SIDED|95.0|0.47|1.57|||Mixed Models Analysis|ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).||||1.57|.47|0.043
91742078|NCT00040742|183377780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.566|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||.017
91742079|NCT00040742|183377780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506|STANDARD_ERROR_OF_MEAN|0.141||0.036|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.036
91742080|NCT00040742|183377780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.269|STANDARD_ERROR_OF_MEAN|0.137||0.431|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.431
91742081|NCT00040742|183377780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.003|TWO_SIDED||||||Mixed Models Analysis|Parameter estimated using a contrast.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs. Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.003
91742082|NCT00040742|183377781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.127||0.046|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.046
91742083|NCT00040742|183377781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.124||0.076|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.076
91742084|NCT00040742|183377781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.12||0.738|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.738
91499991|NCT04446377|182870015|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would induce greater changes in viral load from Day 1 to Day 4 than would Placebo.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.35|TWO_SIDED|95.0|-1.47|0.53||Pre-specified 2-sided significance level of 0.20|Mixed Models Analysis|ANCOVA linear mixed model to evaluate the relative differences between the LAM-002A and Placebo groups in the log10 viral load from Day 1 to Day 4.|The difference between the groups (LAM-002A vs Placebo).|The analysis tested whether the viral load in nasopharyngeal samples was lower at Day 4 in those receiving LAM-002A compared to Placebo.||0.53|-1.47|0.35
91499992|NCT04446377|182870017|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would reduce the cumulative rate of hospitalization or death during the 28-day period comprising 10 days of study drug administration and a further 18 days of observation.|Odds Ratio (OR)|2.03||||0.55|TWO_SIDED|95.0|0.18|22.89|||Log Rank|||||22.89|0.18|0.55
91499993|NCT04446377|182870019|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||Risk Difference from generalized estimating equations (GEE) logistic regression at Baseline||||
91499994|NCT04446377|182870019|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.0|||||TWO_SIDED|||||||||Risk Difference from GEE Logistic Regression at Day 1||||
91499995|NCT04446377|182870019|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-8.8|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 4||||
91535608|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|1.78||0.2144|TWO_SIDED|95.0|-1.3|5.76||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.76|-1.30|0.2144
91742085|NCT00040742|183377781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.013|TWO_SIDED||||||Mixed Models Analysis|Contrasts used for estimation.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.013
91499996|NCT04446377|182870019|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-3.7|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 11||||
91499997|NCT04446377|182870020|SUPERIORITY|The alternative hypothesis for the statistical testing was that, relative to Placebo, LAM-002A would result in a greater proportion of participants with a SARS-CoV-2 viral load \<LLOQ on Day 4.|Relative Risk|2.51||||0.2|TWO_SIDED|95.0|0.74|8.48||Prespecified significance level of 0.20.|Fisher Exact|||||8.48|0.74|0.20
91499998|NCT01862874|182870068|SUPERIORITY||Vaccine Efficacy|85.9|||<|0.001|TWO_SIDED|95.0|52.7|97.3|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 group versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.|97.3|52.7|<0.001
91742086|NCT01434654|183377793|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for arm\*time interaction fixed effect.|Mixed Models Analysis|49 datapoints included from baseline, 6 months, and 12 months visits (low CNS penetrance n=14; high CNS penetrance n=35)||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.99
91742087|NCT01434654|183377794|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in NAA/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
91499999|NCT01862874|182870069|OTHER|Statistical testing of no difference in incidence of maximum temperature ≥37.5°C|Risk Difference (RD)|-1.2||||0.256|TWO_SIDED|95.0|-3.5|0.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.9|-3.5|0.256
91500000|NCT01862874|182870070|OTHER|Statistical testing of no difference in incidence of injection-site erythema|Risk Difference (RD)|2.9||||0.251|TWO_SIDED|95.0|-2.1|7.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site erythema||7.9|-2.1|0.251
91500001|NCT01862874|182870070|OTHER|Statistical testing of no difference in incidence of injection-site pain|Risk Difference (RD)|6.4||||0.033|TWO_SIDED|95.0|0.5|12.2|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site pain||12.2|0.5|0.033
91500002|NCT01862874|182870070|OTHER|Statistical testing of no difference in incidence of injection-site swelling|Risk Difference (RD)|6.8||||0.003|TWO_SIDED|95.0|2.3|11.3|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site swelling||11.3|2.3|0.003
91500003|NCT01862874|182870071|OTHER|Statistical testing of no difference in incidence of systemic AEs|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-5.2|3.3|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||3.3|-5.2|
91500004|NCT01862874|182870072|OTHER|Statistical testing of no difference in incidence of vaccine-related systemic AEs|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-4.1|0.8|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.8|-4.1|
91742088|NCT01434654|183377794|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Change in Cr/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.44
91500005|NCT01862874|182870073|SUPERIORITY||Vaccine Efficacy|86.5|||<|0.001|TWO_SIDED|95.0|55.2|97.4|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.|97.4|55.2|<0.001
91500006|NCT02056340|182870083|OTHER|||||||0.611||||||Threshold for significaance was p value \<0.05.|Mixed Models Analysis|||We used a linear mixed-effects model which accounted for all measurements taken and the time that those measurements were taken.||||0.611
91500007|NCT02056340|182870084|OTHER|||||||0.029||||||P value reflects baseline to 72 hours between groups. A p-value \<0.05 will be considered significant.|Mixed Models Analysis|||The primary comparison was at 72 hours for the self-reported influenza severity score.||||0.029
91742089|NCT01434654|183377794|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||Change in Cho/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.86
91742090|NCT01434654|183377794|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||Change in mIo/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.98
91742091|NCT01434654|183377795|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.16
91742092|NCT01434654|183377795|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.09
91742093|NCT01434654|183377795|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.06
91742094|NCT01434654|183377795|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.68
91742095|NCT01434654|183377795|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
91742096|NCT00363142|183377797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of FPV/r100 to FPV/r200 would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in percentage of participants not meeting the virologic failure definition \[FPV/r100 minus FPV/r200\] was -12% or greater.|Difference in the percentages|-2.12||||||95.0|-9.36|5.12|||||Difference in percentages = percentage in Arm 1 minus percentage in Arm 2|||5.12|-9.36|
91742097|NCT01313910|183377810|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxin-rank test used to determine decrease in bowel movements/day after 8 weeks of intervention||||0.008
91742098|NCT01313910|183377811|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91500008|NCT00883116|182870091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.0397|TWO_SIDED|95.0|1.0|1.7|||Log Rank|||||1.7|1.0|0.0397
91500009|NCT00883116|182870092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.8011|TWO_SIDED|95.0|0.8|1.3|||Log Rank|||||1.3|0.8|0.8011
91500010|NCT01031069|182870125|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-16 type.|Adjusted GMT ratio|2.95|||||TWO_SIDED|95.0|1.92|4.52||||||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.52|1.92|
91742099|NCT01313910|183377812|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91742100|NCT01313910|183377814|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91742101|NCT01340664|183377817|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.637|-0.251|||ANCOVA|||||-0.251|-0.637|<0.001
91742102|NCT01340664|183377817|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.792|-0.407|||ANCOVA|||||-0.407|-0.792|<0.001
91742103|NCT01340664|183377818|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-23.6|STANDARD_ERROR_OF_MEAN|4.673|<|0.001|TWO_SIDED|95.0|-32.78|-14.38|||ANCOVA|||||-14.38|-32.78|<0.001
91742104|NCT01340664|183377818|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-24.0|STANDARD_ERROR_OF_MEAN|4.661|<|0.001||95.0|-33.18|-14.83|||ANCOVA|||||-14.83|-33.18|<0.001
91742105|NCT01340664|183377819|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.1|-1.3|||ANCOVA|||||-1.3|-3.1|<0.001
91742106|NCT01340664|183377819|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
91742107|NCT01340664|183377820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.013|TWO_SIDED|95.0|1.21|4.9|||Regression, Logistic|||||4.90|1.21|0.013
91742108|NCT01340664|183377820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.001|TWO_SIDED|95.0|1.68|6.81|||Regression, Logistic|||||6.81|1.68|<0.001
91742109|NCT03035864|183377830|SUPERIORITY||difference in LS means|-0.11|||=|0.974|TWO_SIDED|95.0|-6.85|6.63|||ANCOVA|||Frequency statistical analysis||6.63|-6.85|=0.974
91742110|NCT03035864|183377830|SUPERIORITY||Difference in least square means|2.88|||=|0.399|TWO_SIDED|95.0|-3.85|9.61|||ANCOVA|||Statistical analysis related to severity||9.61|-3.85|=0.399
91742111|NCT03035864|183377831|SUPERIORITY||difference in least square means|0.04|||=|0.214|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.10|-0.02|=0.214
91742112|NCT03035864|183377835|SUPERIORITY||difference in least square means|-0.43|||=|0.881|TWO_SIDED|95.0|-6.13|5.27|||ANCOVA|||Frequency - week 4||5.27|-6.13|=0.881
91742113|NCT03035864|183377835|SUPERIORITY||difference in least square means|-0.31|||=|0.926|TWO_SIDED|95.0|-6.96|6.33|||ANCOVA|||Frequency - week 8||6.33|-6.96|=0.926
91742114|NCT03035864|183377835|SUPERIORITY||difference in least square means|-2.29|||=|0.426|TWO_SIDED|95.0|-7.97|3.38|||ANCOVA|||Frequency - Week 12||3.38|-7.97|=0.426
91500011|NCT01031069|182870125|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-18 type.|Adjusted GMT ratio|7.83|||||TWO_SIDED|95.0|4.84|12.66||||||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|12.66|4.84|
91742115|NCT03035864|183377835|SUPERIORITY||Difference in least square means|0.62|||=|0.828|TWO_SIDED|95.0|-5.04|6.29|||ANCOVA|||Severity - Week 4||6.29|-5.04|=0.828
91742116|NCT03035864|183377835|SUPERIORITY||difference in least square means|2.86|||=|0.394|TWO_SIDED|95.0|-3.75|9.47|||ANCOVA|||Severity - Week 8||9.47|-3.75|=0.394
91742117|NCT03035864|183377835|SUPERIORITY||difference in least square means|-1.49|||=|0.552|TWO_SIDED|95.0|-6.41|3.44|||ANCOVA|||Severeity - Week 12||3.44|-6.41|=0.552
91742118|NCT02340169|183377843|OTHER||||||||||||||||||Adrenal suppression rates in the evaluable population were 35% (21 out of 60), 43.3% (13 out of 30) and 20% (2 out of 10) in Cohorts 1, 2 a nd 3, respectively.|||
91742119|NCT03063606|183377855|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.0002|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.0002
91742120|NCT03063606|183377856|SUPERIORITY|||||||0.83||||||Analyses used all available data. Analyses to compare treatments were all intent-to-treat.|Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.83
91742121|NCT03744910|183377878|OTHER||Treatment difference|-2.75|STANDARD_ERROR_OF_MEAN|1.563|||TWO_SIDED|95.0|-5.84|0.35||||||||0.35|-5.84|
91742122|NCT03430843|183377909|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.57|0.85|||1-sided, Log Rank Test|||||0.85|0.57|0.0001
91742123|NCT05360966|183377942|OTHER|Difference (2-sided)|Difference in Percentages|38.8|||<|0.0001|TWO_SIDED|95.0|30.8|46.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|46.8|30.8|<0.0001
91742124|NCT05360966|183377943|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.08||0.1321|TWO_SIDED|95.0|-7.2|0.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||0.9|-7.2|0.1321
91742125|NCT05360966|183377944|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.3|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|6.9|9.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.8|6.9|<0.0001
91742126|NCT05360966|183377945|OTHER|Difference (2-sided)|Difference in Percentages|40.1|||<|0.0001|TWO_SIDED|95.0|32.3|47.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|47.9|32.3|<0.0001
91742127|NCT05360966|183377946|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|6.3|8.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||8.9|6.3|<0.0001
91742128|NCT05360966|183377947|OTHER|Difference (2 sided)|Difference in Percentages|37.3|||<|0.0001|TWO_SIDED|95.0|28.7|45.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|45.9|28.7|<0.0001
91742129|NCT05360966|183377948|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|6.5|9.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.6|6.5|<0.0001
91742130|NCT05360966|183377949|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.4||0.5626|TWO_SIDED|95.0|-6.1|3.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.3|-6.1|0.5626
91742131|NCT05360966|183377950|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.53||0.5981|TWO_SIDED|95.0|-6.3|3.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.6|-6.3|0.5981
91742132|NCT05360966|183377951|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.44||0.5161|TWO_SIDED|95.0|-6.4|3.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.2|-6.4|0.5161
91742133|NCT05360966|183377952|OTHER|Difference (2-sided)|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.51||0.8574|TWO_SIDED|95.0|-4.5|5.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||5.4|-4.5|0.8574
91742134|NCT05360966|183377953|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.69||0.698|TWO_SIDED|95.0|-6.3|4.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||4.2|-6.3|0.6980
91742135|NCT01477710|183377962|SUPERIORITY_OR_OTHER_LEGACY||ANOVA F-value|266.39|||<|0.0001||||||This p-value is for the omnibus F-test of between-treatment differences in tidal volume|ANOVA|The p-value for the omnibus F-test was \<0.0001||Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.||||<0.0001
91742136|NCT01477710|183377962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|314.4|||<|0.0001||95.0|264.7|364.1|||t-test, 2 sided|||||364.1|264.7|<0.0001
91742137|NCT01477710|183377962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|576.6|STANDARD_ERROR_OF_MEAN|25.0|<|0.0001|TWO_SIDED|95.0|526.9|626.3|||t-test, 2 sided|||||626.3|526.9|<0.0001
91742138|NCT01477710|183377962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|262.2|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|212.5|312.0|||t-test, 2 sided|||||312.0|212.5|<0.0001
91742139|NCT01893411|183377969|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean difference|-0.04|||=|0.65|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measure|||||0.14|-0.23|= 0.65
91742140|NCT01893411|183377969|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|-0.04|||=|0.741|TWO_SIDED|95.0|-0.26|0.18|||Mixed Model Repeated Measure|||||0.18|-0.26|= 0.741
91742141|NCT01893411|183377970|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.16|||=|0.075|TWO_SIDED|95.0|-0.02|0.34|||Mixed Model Repeated Measure|||||0.34|-0.02|= 0.075
91742142|NCT01893411|183377970|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.06|||=|0.603|TWO_SIDED|95.0|-0.16|0.27|||Mixed Model Repeated Measure|||||0.27|-0.16|= 0.603
91742143|NCT01498692|183378002|SUPERIORITY_OR_OTHER||Percent Target Lesion Failure|2.4|||<|0.0001|ONE_SIDED|95.0||7.3|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 21.1%.||7.3||<0.0001
91742144|NCT03782259|183378042|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
91742145|NCT03782259|183378043|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
91742146|NCT02978157|183378060|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91742147|NCT00485758|183378064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-21.4|-14.4|||Wilcoxon (Mann-Whitney)|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.||||-14.4|-21.4|<0.001
91742148|NCT00485758|183378065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|20.7|25.7|||Repeated Measures Analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.||||25.7|20.7|<0.001
91742149|NCT00485758|183378066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.1|||<|0.001||95.0|-27.2|-18.9|||ANCOVA|Nonparametric Analysis of Covariance model based on Tukey's normalized ranks with term for treatment, gender and Tukey's normal score of baseline.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon's rank|||-18.9|-27.2|<0.001
91742150|NCT00135330|183378073|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|||The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.||||0.282
91742151|NCT00135330|183378074|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||||||0.004
91742152|NCT00135330|183378075|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||ANCOVA|||||||0.308
91742153|NCT00135330|183378076|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
91513597|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|6.7|||<|0.001|TWO_SIDED|95.0|4.6|9.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||9.2|4.6|< 0.001
91742154|NCT00135330|183378077|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||ANCOVA|||||||0.252
91742155|NCT00135330|183378078|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||ANCOVA|||||||0.465
91742156|NCT00135330|183378079|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||ANCOVA|||||||0.348
91742157|NCT00135330|183378083|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Mixed Model Repeated Measures (MMRM)|||||||0.039
91742158|NCT00135330|183378084|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||MMRM|||||||0.555
91742159|NCT00135330|183378086|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||MMRM|||||||0.106
91742160|NCT00135330|183378087|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||MMRM|||||||0.341
91742161|NCT00135330|183378088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||MMRM|||||||<0.001
91742162|NCT00135330|183378089|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||MMRM|||||||0.276
91742163|NCT00135330|183378090|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||MMRM|||||||0.840
91742164|NCT00135330|183378091|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||MMRM|||||||0.096
91742165|NCT00135330|183378092|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||MMRM|||||||0.875
91742166|NCT00135330|183378093|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|||||||0.581
91742167|NCT00135330|183378094|SUPERIORITY_OR_OTHER|||||||0.631||95.0|||||ANCOVA|||||||0.631
91742168|NCT00135330|183378095|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||ANCOVA|||||||0.724
91742169|NCT00135330|183378096|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||MMRM|||||||0.117
91742170|NCT00135330|183378097|SUPERIORITY_OR_OTHER|||||||0.251||95.0|||||MMRM|||||||0.251
91742171|NCT00135330|183378098|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||MMRM|||||||0.710
91742172|NCT00135330|183378099|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Fisher Exact|||||||0.575
91742173|NCT00135330|183378100|SUPERIORITY_OR_OTHER|||||||0.436||95.0|||||ANOVA|||||||0.436
91742174|NCT00135330|183378101|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Generalized Linear Model|||||||0.168
91742175|NCT01771991|183378103|SUPERIORITY||sum of scores|453.0|STANDARD_DEVIATION|39.6||0.57|TWO_SIDED||||||Wilcoxon Rank-Sum||Standard Deviation under the Null hypothesis for each group.|||||0.57
91500012|NCT01031069|182870126|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.|Adjusted GMT ratio|7.44|||<|0.0001|TWO_SIDED|95.0|4.79|11.54|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|11.54|4.79|<0.0001
91742176|NCT01771991|183378104|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|1.5||0.65|TWO_SIDED|95.0|-0.6|0.95|||t-test, 2 sided|||Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.||0.95|-0.60|0.65
91742177|NCT01771991|183378105|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_DEVIATION|17.79||0.57|TWO_SIDED|95.0|-6.65|11.91|||t-test, 2 sided|||Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.||11.91|-6.65|0.57
91742178|NCT02229825|183378123|OTHER|||||||0.88||||||p-value for treatment effect|ANCOVA|ANCOVA with stratification factors (country and pretreatment) and baseline score and treatment as the main factor.||The null hypothesis was that the mean change in MADRS total score between week 4 and baseline was the same for the 2 duloxetine treatment groups.||||0.88
91742179|NCT02229825|183378124|OTHER|||||||0.86||||||Treatment effect.|ANCOVA|Analysis of covariance (ANCOVA) with stratification factors and HAMD6 baseline as covariates and treatment regimen as main factor.||Comparison between treatment regimes at Week 4.||||0.86
91742180|NCT02229825|183378125|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparisons, week 8 versus baseline.||||<0.0001
91742181|NCT02229825|183378125|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742182|NCT02229825|183378125|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742183|NCT02229825|183378125|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742184|NCT02229825|183378127|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
91742185|NCT02229825|183378127|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
91742186|NCT02229825|183378127|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
91742187|NCT02229825|183378127|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
91742188|NCT02229825|183378128|OTHER|||||||0.32||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.32
91742189|NCT02229825|183378130|OTHER|||||||0.57||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.57
91742190|NCT02229825|183378133|OTHER|||||||0.68|||||||Cochran-Mantel-Haenszel|Stratified by country, 60 mg vs. 120 mg||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.68
91742191|NCT02229825|183378134|OTHER||Statistic|-528.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
91742192|NCT02229825|183378134|OTHER||Statistic|-540.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
91742193|NCT02229825|183378134|OTHER||Statistic|-1024.5|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
91742194|NCT02229825|183378134|OTHER||Statistic|-279.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
91742195|NCT02229825|183378135|OTHER|No formal hypothesis was tested.||||||0.07||||||Stratified by country, 60 mg vs. 120 mg|Cochran-Mantel-Haenszel|||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.07
91742196|NCT02229825|183378137|OTHER||CMH statistic|0.0||||1|||||||Cochran-Mantel-Haenszel|||"Before testing, PGI-I items were pooled to reduce the possible number of classes. The 3 classes used (instead of 7 items) were: 1-2= improved, 3-5=Stable, 6-7=Worsened. At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||1.00
91742197|NCT02229825|183378139|OTHER|||||||0.92||||||Treatment effect|ANCOVA|||Comparison between HAMA scores between treatment regimens.||||0.92
91742198|NCT02229825|183378140|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742199|NCT02229825|183378140|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742200|NCT02229825|183378140|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742201|NCT02229825|183378140|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742202|NCT02229825|183378142|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, Week 8 versus baseline.||||<0.0001
91742203|NCT02229825|183378142|OTHER|||||||0.001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.001
91742204|NCT02229825|183378142|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
91742205|NCT02229825|183378142|OTHER|||||||0.28|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.28
91742206|NCT01309997|183378155|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91742207|NCT01309997|183378155|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91742208|NCT02526212|183378164|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.||||0.44
91742209|NCT02526212|183378167|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.||||0.20
91742210|NCT00237666|183378169|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91742211|NCT03645096|183378182|SUPERIORITY||Mean Difference (Final Values)|0.0493|STANDARD_ERROR_OF_MEAN|0.0554||0.195|TWO_SIDED|95.0|-0.0703|0.1689||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1689|-0.0703|.195
91742212|NCT03645096|183378182|SUPERIORITY||Mean Difference (Final Values)|0.0262|STANDARD_ERROR_OF_MEAN|0.0565||0.325|TWO_SIDED|95.0|-0.0943|0.1467||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1467|-0.0943|.325
91742213|NCT03645096|183378183|SUPERIORITY||Mean Difference (Final Values)|-0.0071|STANDARD_ERROR_OF_MEAN|0.0878||0.468|TWO_SIDED|95.0|-0.1969|0.1827||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1827|-0.1969|.468
91742214|NCT03645096|183378183|SUPERIORITY||Mean Difference (Final Values)|0.0097|STANDARD_ERROR_OF_MEAN|0.0891||0.458|TWO_SIDED|95.0|-0.1803|0.1996||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1996|-0.1803|.458
91742215|NCT03645096|183378184|SUPERIORITY||Mean Difference (Final Values)|0.0038|STANDARD_ERROR_OF_MEAN|0.0078||0.316|TWO_SIDED|95.0|-0.0132|0.0209||Paired samples t-test with corrected standard deviation of the difference.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0209|-0.0132|.316
91742216|NCT03645096|183378184|SUPERIORITY||Mean Difference (Final Values)|0.0131|STANDARD_ERROR_OF_MEAN|0.0084||0.071|TWO_SIDED|95.0|-0.005|0.0312||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0312|-0.0050|.071
91742217|NCT03645096|183378185|SUPERIORITY||Mean Difference (Final Values)|-11322.45|STANDARD_ERROR_OF_MEAN|3750.52||0.006|TWO_SIDED|95.0|-19577.27|-3067.62||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be greater than that at placebo."||-3067.62|-19577.27|.006
91742218|NCT03645096|183378185|SUPERIORITY||Mean Difference (Final Values)|-11828.78|STANDARD_ERROR_OF_MEAN|3620.42||0.003|TWO_SIDED|95.0|-19650.24|-4007.33||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be greater than that at placebo."||-4007.33|-19650.24|.003
91742219|NCT03645096|183378186|SUPERIORITY||Mean Difference (Final Values)|-2523.58|STANDARD_ERROR_OF_MEAN|545.83||0.001|TWO_SIDED|95.0|-3724.93|-1322.22||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be greater than that at placebo."||-1322.22|-3724.93|.001
91742220|NCT03645096|183378186|SUPERIORITY||Mean Difference (Final Values)|-2480.62|STANDARD_ERROR_OF_MEAN|582.63||0.001|TWO_SIDED|95.0|-3739.32|-1221.93||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be greater than that at placebo."||-1221.93|-3739.32|.001
91759516|NCT02391363|183411767|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
91500013|NCT01031069|182870126|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.|Adjusted GMT ratio|2.74|||<|0.0001|TWO_SIDED|95.0|1.83|4.11|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.11|1.83|<0.0001
91500014|NCT01031069|182870143|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|5.38|||<|0.0001|TWO_SIDED|97.5|3.2|9.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||9.06|3.20|<0.0001
91500015|NCT01031069|182870143|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|3.05|||<|0.0001|TWO_SIDED|97.5|1.84|5.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||5.06|1.84|<0.0001
91500016|NCT01317160|182870148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Chi-squared|||Domeij-Arverud et al., Bone Joint J 2015;97-B:675-80.||||0.042
91500017|NCT01317160|182870148|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81|||<|0.05|TWO_SIDED|95.0|1.25|6.32|||Regression, Logistic|Age was adjusted for in the calculation.|Risk of VTE by routine care (numerator) divided by IPC treatment (denominator)|||6.32|1.25|<0.05
91500018|NCT01317160|182870150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.737|TWO_SIDED||||||Chi-squared|||||||0.737
91742221|NCT03645096|183378187|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|0.7059|STANDARD_ERROR_OF_MEAN|1.6377||0.336|TWO_SIDED|95.0|-2.7659|4.1777||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: SAFTEE (total) scores at 500 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 500 mg will be less than that at placebo."||4.1777|-2.7659|.336
91760127|NCT01393639|183411996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.46|0.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.57|-0.46|
91500019|NCT03578367|182870178|OTHER|No test performed|Risk Difference (RD)|19.5|||||TWO_SIDED|90.0|5.0|33.1||||||||33.1|5.0|
91500020|NCT03578367|182870178|OTHER|No test performed|Risk Difference (RD)|28.57|||||TWO_SIDED|90.0|12.4|44.8||||||||44.8|12.4|
91500021|NCT03578367|182870179|OTHER|No test performed|Risk Difference (RD)|14.29|||||TWO_SIDED|90.0|-1.7|30.3||||||||30.3|-1.7|
91500022|NCT03578367|182870179|OTHER|No test performed|Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|5.9|41.7||||||||41.7|5.9|
91500023|NCT01705288|182870197|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.36
91500024|NCT01705288|182870198|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.05
91500025|NCT01705288|182870199|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91500026|NCT00670800|182870208|SUPERIORITY_OR_OTHER|||||||0.143||95.0|||||t-test, 2 sided|||||||0.143
91500027|NCT00670800|182870208|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.900
91500028|NCT00670800|182870208|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||t-test, 2 sided|||||||0.133
91500029|NCT00670800|182870209|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
91500030|NCT00670800|182870209|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||t-test, 2 sided|||||||0.717
91500031|NCT00670800|182870209|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
91500032|NCT00670800|182870210|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||t-test, 2 sided|||||||0.498
91500033|NCT00670800|182870210|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||t-test, 2 sided|||||||0.835
91500034|NCT00670800|182870210|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||t-test, 2 sided|||||||0.606
91500035|NCT00670800|182870211|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||t-test, 2 sided|||||||0.118
91500036|NCT00670800|182870211|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||t-test, 2 sided|||||||0.581
91500037|NCT00670800|182870211|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||||||0.190
91500038|NCT03274687|182870237|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5.||||||0.98|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.98
91742222|NCT03645096|183378187|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|3.4662||0.24|TWO_SIDED|95.0|-9.8131|4.8131||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: SAFTEE (total) scores at 800 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 800 mg will be less than that at placebo."||4.8131|-9.8131|.240
91742223|NCT04904744|183378205|SUPERIORITY||Odds Ratio (OR)|1.35||||0.165|TWO_SIDED|95.0|0.88|2.06|||Regression, Logistic||Low Tailored Message vs. No Message (reference group)|||2.06|0.88|0.165
91742224|NCT04904744|183378205|SUPERIORITY||Odds Ratio (OR)|1.33||||0.193|TWO_SIDED|95.0|0.87|2.03|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.03|0.87|0.193
91742225|NCT04904744|183378205|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.68|1.52|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||1.52|0.68|0.930
91742226|NCT04904744|183378206|SUPERIORITY||Odds Ratio (OR)|2.07||||0.008|TWO_SIDED|95.0|1.21|3.52|||Regression, Logistic||Low Tailored Message vs. No Message|||3.52|1.21|0.008
91742227|NCT04904744|183378206|SUPERIORITY||Odds Ratio (OR)|1.25||||0.457|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.23|0.70|0.457
91742228|NCT04904744|183378206|SUPERIORITY||Odds Ratio (OR)|1.66||||0.049|TWO_SIDED|95.0|1.0|2.74|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||2.74|1.00|0.049
91742229|NCT04904744|183378207|SUPERIORITY||Odds Ratio (OR)|2.04||||0.104|TWO_SIDED|95.0|0.86|4.82|||Regression, Logistic||Low Tailored Message vs. No Message|||4.82|0.86|0.104
91742230|NCT04904744|183378207|SUPERIORITY||Odds Ratio (OR)|1.26||||0.631|TWO_SIDED|95.0|0.49|3.22|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||3.22|0.49|0.631
91742231|NCT04904744|183378207|SUPERIORITY||Odds Ratio (OR)|1.62||||0.238|TWO_SIDED|95.0|0.73|3.61|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||3.61|0.73|0.238
91742232|NCT04283656|183378238|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
91742233|NCT04283656|183378239|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.66|1.32||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.32|0.66|
91742234|NCT04283656|183378240|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
91742235|NCT04283656|183378241|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.91|1.5||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.50|0.91|
91500039|NCT03274687|182870238|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6.||||||0.96|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.96
91500040|NCT03274687|182870239|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||End of RT||||0.70
91742236|NCT04283656|183378242|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.73|2.6||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||2.60|0.73|
91742237|NCT04283656|183378243|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.14|||||TWO_SIDED|90.0|0.93|1.4||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.40|0.93|
91742238|NCT04283656|183378244|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.7|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for estradiol AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.70|
91742239|NCT04283656|183378245|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|0.92|1.36||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.36|0.92|
91500041|NCT03274687|182870239|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||6 months||||0.67
91500042|NCT03274687|182870239|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||1 year||||0.66
91500043|NCT03274687|182870240|SUPERIORITY|||||||0.0011|||||||t-test, 2 sided|||End of RT||||0.0011
91500044|NCT03274687|182870240|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||6 months||||0.93
91500045|NCT03274687|182870240|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||1 year||||0.30
91500046|NCT03274687|182870241|SUPERIORITY|||||||0.29|||||||Gray's test|Two-sided significance level 0.05||Protocol definition of biochemical failure||||0.29
91500047|NCT03274687|182870241|SUPERIORITY|||||||0.22|||||||Gray's test|Two-sided significance level 0.05||Phoenix definition of biochemical failure||||0.22
91500048|NCT03274687|182870242|SUPERIORITY|||||||0.96||||||Two-sided significance level 0.05|Gray's test|||||||0.96
91742240|NCT04283656|183378246|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.88|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol C12 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.88|
91742241|NCT00803361|183378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.006|TWO_SIDED|95.0|-2.76|-0.48||p-value is for Change from Baseline.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.48|-2.76|0.006
91742242|NCT00803361|183378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.024|TWO_SIDED|95.0|-4.78|-0.34||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.34|-4.78|0.024
91500049|NCT03274687|182870243|SUPERIORITY|||||||0.35||||||Two-sided significance level 0.05|Gray's test|||||||0.35
91500050|NCT03274687|182870244|SUPERIORITY|||||||0.41||||||Two-sided significance level 0.05|Gray's test|||||||0.41
91500051|NCT03274687|182870245|SUPERIORITY|||||||0.6||||||Two-sided significance level 0.05|Gray's test|||||||0.60
91500052|NCT03274687|182870247|SUPERIORITY||Hazard Ratio (HR)|1.58||||0.61|TWO_SIDED|95.0|0.26|9.47||Two-side significance level 0.05|Log Rank||Reference = COPORT|||9.47|0.26|0.61
91500053|NCT03274687|182870248|SUPERIORITY|||||||0.53|||||||Chi-squared|||Patients with any grade 3 or higher adverse event of any attribution||||0.53
91500054|NCT03274687|182870248|SUPERIORITY|||||||0.6929|||||||Chi-squared|||Patients with any grade 3 or higher gastrointestinal adverse event of any attribution||||0.6929
91500055|NCT03274687|182870248|SUPERIORITY|||||||0.2605|||||||Chi-squared|||Patients with any grade 3 or higher genitourinary adverse event of any attribution||||0.2605
91500056|NCT01199289|182870273|SUPERIORITY||LS Mean Difference|-0.068||||0.5838|TWO_SIDED|95.0|-0.311|0.175|||ANCOVA|||||0.175|-0.311|0.5838
91500057|NCT01199289|182870273|SUPERIORITY||LS Mean Difference|-0.075||||0.5391|TWO_SIDED|95.0|-0.316|0.166|||ANCOVA|||||0.166|-0.316|0.5391
91500058|NCT01199289|182870273|SUPERIORITY||LS Mean Difference|-0.113||||0.3583|TWO_SIDED|95.0|-0.355|0.129|||ANCOVA|||||0.129|-0.355|0.3583
91500059|NCT01199289|182870274|SUPERIORITY||LS Mean Difference|-0.047||||0.4076|TWO_SIDED|95.0|-0.157|0.064|||ANCOVA|||Pre-Bronchodilator||0.064|-0.157|0.4076
91500060|NCT01199289|182870274|SUPERIORITY||LS Mean Difference|-0.022||||0.6915|TWO_SIDED|95.0|-0.13|0.086|||ANCOVA|||Pre-Bronchodilator||0.086|-0.130|0.6915
91500061|NCT01199289|182870274|SUPERIORITY||LS Mean Difference|-0.019||||0.7271|TWO_SIDED|95.0|-0.126|0.088|||ANCOVA|||Pre-Bronchodilator||0.088|-0.126|0.7271
91500062|NCT01199289|182870274|SUPERIORITY||LS Mean Difference|0.005||||0.921|TWO_SIDED|95.0|-0.086|0.095|||ANCOVA|||Post-Bronchodilator||0.095|-0.086|0.9210
91500063|NCT01199289|182870274|SUPERIORITY||LS Mean Difference|0.07||||0.1139|TWO_SIDED|95.0|-0.017|0.157|||ANCOVA|||Post-Bronchodilator||0.157|-0.017|0.1139
91500064|NCT01199289|182870274|SUPERIORITY||LS Mean Difference|0.021||||0.6426|TWO_SIDED|95.0|-0.066|0.107|||ANCOVA|||Post-Bronchodilator||0.107|-0.066|0.6426
91500065|NCT01199289|182870275|SUPERIORITY||LS Mean Difference|-16.847||||0.0262|TWO_SIDED|95.0|-31.686|-2.009|||ANCOVA|||AM||-2.009|-31.686|0.0262
91500066|NCT01199289|182870275|SUPERIORITY||LS Mean Difference|-6.723||||0.3627|TWO_SIDED|95.0|-21.239|7.793|||ANCOVA|||AM||7.793|-21.239|0.3627
91500067|NCT01199289|182870275|SUPERIORITY||LS Mean Difference|-5.488||||0.4507|TWO_SIDED|95.0|-19.791|8.814|||ANCOVA|||AM||8.814|-19.791|0.4507
91742243|NCT00803361|183378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15|||ANOVA|||||-0.15|-0.74|0.004
91742244|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.125|TWO_SIDED|95.0|-0.93|0.11||p-value is for Severity of Worst Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.93|0.125
91742245|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.014|TWO_SIDED|95.0|-0.75|-0.09||p-value is for Severity of Least Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.09|-0.75|0.014
91500068|NCT01199289|182870275|SUPERIORITY||LS Mean Difference|-10.426||||0.1228|TWO_SIDED|95.0|-23.686|2.834|||ANCOVA|||PM||2.834|-23.686|0.1228
91742246|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.012|TWO_SIDED|95.0|-0.93|-0.11||p-value is for Severity of Average Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.11|-0.93|0.012
91742247|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.002|TWO_SIDED|95.0|-1.14|-0.25||p-value is for Severity of Pain Right Now Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.25|-1.14|0.002
91742248|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.101|TWO_SIDED|95.0|-0.87|0.08||p-value is for Interference of Pain, General Activity, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-0.87|0.101
91742249|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.252|TWO_SIDED|95.0|-0.83|0.22||p-value is for Interference of Pain, Mood, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.22|-0.83|0.252
91742250|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.149|TWO_SIDED|95.0|-0.72|0.11||p-value is for Interference of Pain,Walking Ability, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.72|0.149
91742251|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.367|TWO_SIDED|95.0|-0.71|0.26||p-value is for Interference of Pain, Normal Work, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.26|-0.71|0.367
91500069|NCT01199289|182870275|SUPERIORITY||LS Mean Difference|-6.738||||0.3092|TWO_SIDED|95.0|-19.758|6.281|||ANCOVA|||PM||6.281|-19.758|0.3092
91500070|NCT01199289|182870275|SUPERIORITY||LS Mean Difference|-8.043||||0.2167|TWO_SIDED|95.0|-20.831|4.744|||ANCOVA|||PM||4.744|-20.831|0.2167
91500071|NCT01199289|182870276|SUPERIORITY||LS Mean Difference|0.331||||0.5157|TWO_SIDED|95.0|-0.67|1.332|||ANCOVA|||||1.332|-0.670|0.5157
91500072|NCT01199289|182870276|SUPERIORITY||LS Mean Difference|-0.234||||0.6434|TWO_SIDED|95.0|-1.229|0.76|||ANCOVA|||||0.760|-1.229|0.6434
91500073|NCT01199289|182870276|SUPERIORITY||LS Mean Difference|-0.199||||0.6954|TWO_SIDED|95.0|-1.196|0.799|||ANCOVA|||||0.799|-1.196|0.6954
91500074|NCT01199289|182870277|SUPERIORITY||LS Mean Difference|-0.283||||0.5577|TWO_SIDED|95.0|-1.231|0.665|||ANCOVA|||||0.665|-1.231|0.5577
91500075|NCT01199289|182870277|SUPERIORITY||LS Mean Difference|0.038||||0.9366|TWO_SIDED|95.0|-0.904|0.98|||ANCOVA|||||0.980|-0.904|0.9366
91500076|NCT01199289|182870277|SUPERIORITY||LS Mean Difference|0.138||||0.7745|TWO_SIDED|95.0|-0.808|1.084|||ANCOVA|||||1.084|-0.808|0.7745
91500077|NCT01199289|182870278|SUPERIORITY||LS Mean Difference|0.026||||0.8524|TWO_SIDED|95.0|-0.251|0.303|||ANCOVA|||||0.303|-0.251|0.8524
91742252|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.395|TWO_SIDED|95.0|-0.59|0.24||p-value is for Interference of Pain, Relations with Others, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.24|-0.59|0.395
91742253|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.731|TWO_SIDED|95.0|-0.63|0.44||p-value is for Interference of Pain, Sleep, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.44|-0.63|0.731
91742254|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.186|TWO_SIDED|95.0|-0.85|0.17||p-value is for Interference of Pain, Enjoyment of Life, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-0.85|0.186
91742255|NCT00803361|183378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.22|TWO_SIDED|95.0|-0.67|0.16||p-value is for Mean Interference Score, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.16|-0.67|0.220
91742256|NCT00803361|183378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.076|TWO_SIDED|95.0|-1.29|0.06||p-value is for symptoms have disrupted your work/schoolwork - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.29|0.076
91742257|NCT00803361|183378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.16|0.17||p-value is for symptoms disrupted social/leisure - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-1.16|0.140
91742258|NCT00803361|183378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.087|TWO_SIDED|95.0|-1.14|0.08||p-value is for symptoms disrupted family life - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-1.14|0.087
91742259|NCT00803361|183378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.083|TWO_SIDED|95.0|-3.46|0.21||p-value is for Global Functional Impairment Total Score - change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.21|-3.46|0.083
91742260|NCT00803361|183378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32||||0.063|TWO_SIDED|95.0|-10.93|0.3||p-value is for Severity of Overall Pain, Past Week, Change|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||0.30|-10.93|0.063
91742261|NCT00803361|183378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.66|TWO_SIDED|95.0|-6.64|4.22||p-value is for Severity of Headaches, Past Week, Change.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||4.22|-6.64|0.660
91742262|NCT00803361|183378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.025|TWO_SIDED|95.0|-11.3|-0.76||p-value is for Severity of Back Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.76|-11.30|0.025
91742263|NCT00803361|183378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93||||0.26|TWO_SIDED|95.0|-8.06|2.19||p-value is for Severity of Shoulder Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||2.19|-8.06|0.260
91500078|NCT01199289|182870278|SUPERIORITY||LS Mean Difference|-0.033||||0.8139|TWO_SIDED|95.0|-0.305|0.24|||ANCOVA|||||0.240|-0.305|0.8139
91742264|NCT00803361|183378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.67||||0.145|TWO_SIDED|95.0|-8.61|1.28||p-value is for Pain Interference, Daily Activities, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||1.28|-8.61|0.145
91742265|NCT00803361|183378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.15||||0.011|TWO_SIDED|95.0|-12.64|-1.66||p-value is for Pain During Waking Hours, Past Week, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-1.66|-12.64|0.011
91742266|NCT00803361|183378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.068|TWO_SIDED|95.0|-1.72|0.06||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.72|0.068
91742267|NCT04445519|183378254|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 95.1% CIs around the difference (NCX 470 minus latanoprost 0.005%) in mean IOP reduction from time-matched baseline in the study eye was greater than or equal to -1.5 mmHg at all time points and was greater than or equal to -1.0 mmHg at a majority of the time points.|Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.25|||TWO_SIDED|95.1||||The primary efficacy assessment was the non-inferiority analysis of the difference in the treatment effect between NCX 470 and latanoprost 0.005% for mean IOP reduction from time-matched baseline at the 8AM and 4PM time-points.|||The analysis assumed a true difference of 1.0 mmHg at the Week 2 time points and 1.25 mmHg at the Week 6 and Month 3 time points; a common standard deviation (SD) at each time-point of 3.25 mmHg; and a two-sided significance level of 4.9%.|||||
91742268|NCT00394329|183378262|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.56|STANDARD_ERROR_OF_MEAN|0.28||0.066|TWO_SIDED|95.0|0.32|0.96||Hochberg adjustment was applied to the p-value to account for each of three active group comparisons to the placebo group. The unadjusted p-value is 0.033.|Regression, Cox|||||0.96|0.32|0.066
91742269|NCT04677543|183378309|SUPERIORITY||Percentage Difference|10.4||||0.2819|TWO_SIDED|95.0|-8.6|29.5|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||29.5|-8.6|0.2819
91742270|NCT04677543|183378310|SUPERIORITY||Percentage Difference|6.1||||0.508|TWO_SIDED|95.0|-11.9|24.1|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||24.1|-11.9|0.5080
91500079|NCT01199289|182870278|SUPERIORITY||LS Mean Difference|-0.002||||0.9881|TWO_SIDED|95.0|-0.281|0.276|||ANCOVA|||||0.276|-0.281|0.9881
91742271|NCT04677543|183378311|SUPERIORITY||Percentage Difference|16.7||||0.0712|TWO_SIDED|95.0|-1.4|34.9|||Standardized Logistic Regression|||||34.9|-1.4|0.0712
91742272|NCT04677543|183378312|SUPERIORITY||Least Square Mean Difference|4.48||||0.1073|TWO_SIDED|95.0|-0.97|9.93|||ANCOVA|||||9.93|-0.97|0.1073
91742273|NCT04677543|183378313|SUPERIORITY||Least Square Mean Difference|-0.4||||0.613|TWO_SIDED|95.0|-2.2|1.3|||ANCOVA|||||1.3|-2.2|0.6130
91742274|NCT04677543|183378314|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3542|TWO_SIDED|95.0|0.79|1.92|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||1.92|0.79|0.3542
91742275|NCT04677543|183378315|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.1583|TWO_SIDED|95.0|0.89|2.06|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||2.06|0.89|0.1583
91742276|NCT00995436|183378320|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.53|0.36|||||Maxillary right molar|||0.36|-1.53|
91742277|NCT00995436|183378320|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.89|-0.04|||||Maxillary left molar|||-0.04|-1.89|
91742278|NCT00995436|183378320|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|0.62|||||TWO_SIDED|95.0|-0.32|1.55|||||Maxillary right molar|||1.55|-0.32|
91742279|NCT00995436|183378320|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.0|0.83|||||Maxillary left molar|||0.83|-1|
91742280|NCT00995436|183378320|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.05||||||Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.|ANCOVA|||||||0.05
91742281|NCT00995436|183378320|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.08||||||Overall effect of treatment F(2,67) = 2.58.|ANCOVA|||Maxillary left molar.||||0.08
91742282|NCT01158820|183378385|OTHER|No data available for power analysis|Mean Difference (Net)|0.028|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91742283|NCT01158820|183378386|SUPERIORITY||Mean Difference (Final Values)|43.75|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are µg|See reference power analysis||||<0.01
91742284|NCT01158820|183378387|SUPERIORITY||Median Difference (Final Values)|1.75||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are mg|See reference for power analysis||||0.01
91742285|NCT03299244|183378396|NON_INFERIORITY|Etelcalcetide was considered non-inferior if the upper bound of the two-sided 95% confidence interval of the treatment difference (Cinacalcet - Etelcalcetide) was smaller than 12%, or if the lower bound of (Etelcalcetide - Cinacalcet) greater than -12%. If this criterion was met, the 2 key secondary endpoints were tested sequentially. If both key secondary endpoints were statistically significant, the other secondary endpoints were to be formally tested at an overall significance level of 0.05.|Treatment Difference|4.52|||||TWO_SIDED|95.0|-3.05|12.09|||||Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|"The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (\< 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (\< 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China)."||12.09|-3.05|
91742286|NCT03299244|183378397|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.47|2.77|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||2.77|1.47|<0.001
91742287|NCT03299244|183378398|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint, and superiority was demonstrated for the previous key secondary endpoint.|Odds Ratio (OR)|1.42||||0.033|TWO_SIDED|95.0|1.03|1.96|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.96|1.03|0.033
91742288|NCT03299244|183378399|SUPERIORITY||Difference in Least Squares Means|-2.82|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-4.14|-1.5|||Mixed-effects Model Repeated Measures|Model includes treatment group, randomization stratification factors, study week, and study week by treatment as covariates.|Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.|||-1.50|-4.14|<0.001
91742289|NCT03299244|183378400|SUPERIORITY||Odds Ratio (OR)|1.16||||0.41|TWO_SIDED|95.0|0.82|1.65|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.65|0.82|0.41
91742290|NCT00145626|183378442|SUPERIORITY_OR_OTHER||Cumulative Incidence|0.214|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED||||||||The cumulative incidence estimate and its standard error for occurrence of regimen-related mortality by the end of the first 100 days post-transplant was calculated.|||||
91500080|NCT01199289|182870279|SUPERIORITY|With use of SABA|LS Mean Difference|-0.062||||0.1213|TWO_SIDED|95.0|-0.141|0.017|||ANCOVA|||||0.017|-0.141|0.1213
91742291|NCT01198574|183378474|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GLM for repeated measures|The Hb concentration at Week 0, Week 6 and Week 12 are analyzed using GLM repeated measures.||"Null Hypothesis~1. Haemoglobin level was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the haemoglobin level of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
91742292|NCT01198574|183378475|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null hypothesis~1. Iron status indicator (serum ferritin) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the iron status indicator (serum ferritin) concentration of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
91742293|NCT01198574|183378476|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null Hypothesis~1. iron status indicator (sTfR) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve iron status indicator (sTfR) of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
91742294|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-3.62|-1.22||||||Day 8 Cohort A: TIP, Pooled PBO||-1.22|-3.62|
91742295|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.3|-0.98||||||Day 8 Cohort A: TIP/PBO, Pooled PBO||-0.98|-3.30|
91742296|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-3.2|-0.68||||||Day 8 Cohort B: TIP, Pooled PBO||-0.68|-3.20|
91742297|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.3|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-4.38|-2.15||||||Day 8 Cohort B: TIP/PBO, Pooled PBO|LS Mean Diff (SE) vs pooled placebo|-2.15|-4.38|
91742298|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.0|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-5.06|-2.88||||||Day 8 Cohort C: TIP, Pooled PBO||-2.88|-5.06|
91742299|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.4|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.57|-2.14||||||Day 8 Cohort C: TIP/PBO, Pooled PBO||-2.14|-4.57|
91742300|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-3.66|-1.89||||||Day 8: Pooled TIP, Pooled PBO||-1.89|-3.66|
91742301|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-3.79|-2.05||||||Day 8: Pooled TIP/PBO, Pooled PBO||-2.05|-3.79|
91500081|NCT01199289|182870279|SUPERIORITY|With use of SABA|LS Mean Difference|-0.017||||0.6643|TWO_SIDED|95.0|-0.095|0.061|||ANCOVA|||||0.061|-0.095|0.6643
91500082|NCT01199289|182870279|SUPERIORITY||LS Mean Difference|-0.042||||0.2879|TWO_SIDED|95.0|-0.121|0.036|||ANCOVA|With use of SABA||||0.036|-0.121|0.2879
91742302|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-4.28|-1.31||||||Day 29 Cohort A: TIP, Pooled PBO||-1.31|-4.28|
91742303|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-4.03|-0.67||||||Day 29 Cohort A: TIP/PBO, Pooled PBO||-0.67|-4.03|
91742304|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-4.04|-0.52||||||Day 29 Cohort B: TIP, Pooled PBO||-0.52|-4.04|
91742305|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-5.16|-1.85||||||Day 29 Cohort B: TIP/PBO, Pooled PBO||-1.85|-5.16|
91742306|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.6|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-6.13|-3.09||||||Day 29 Cohort C: TIP, Pooled PBO||-3.09|-6.13|
91500083|NCT01199289|182870279|SUPERIORITY|Without use of SABA|LS Mean Difference|-0.074||||0.0546|TWO_SIDED|95.0|-0.15|0.001|||ANCOVA|||||0.001|-0.150|0.0546
91500084|NCT01199289|182870279|SUPERIORITY||LS Mean Difference|-0.004||||0.9078|TWO_SIDED|95.0|-0.08|0.071|||ANCOVA|||Without use of SABA||0.071|-0.080|0.9078
91742307|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-4.68|-1.52||||||Day 29 Cohort C: TIP/PBO, Pooled PBO||-1.52|-4.68|
91742308|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.2|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.43|-2.02||||||Day 29: Pooled TIP, Pooled PBO||-2.02|-4.43|
91500085|NCT01199289|182870279|SUPERIORITY||LS Mean Difference|-0.035||||0.3616|TWO_SIDED|95.0|-0.111|0.04|||ANCOVA|||Without use of SABA||0.040|-0.111|0.3616
91500086|NCT02636868|182870283|SUPERIORITY|||||||0.363||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO₂) in model||Null hypothesis is no difference across treatment groups||||0.363
91500087|NCT02636868|182870283|SUPERIORITY|||||||0.36||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.360
91742309|NCT02712983|183378477|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.19|-1.78||||||Day 29: Pooled TIP/PBO, Pooled PBO||-1.78|-4.19|
91742310|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-3.82|-0.36||||||Day 57 Cohort A: TIP, Pooled PBO||-0.36|-3.82|
91742311|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.21|1.29||||||Day 57 Cohort A: TIP/PBO, Pooled PBO||1.29|-2.21|
91742312|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.87|0.08||||||Day 57 Cohort B: TIP, Pooled PBO||0.08|-3.87|
91742313|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-3.34|0.16||||||Day 57 Cohort B: TIP/PBO, Pooled PBO||0.16|-3.34|
91742314|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.9|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-5.5|-2.22||||||Day 57 Cohort C: TIP, Pooled PBO||-2.22|-5.50|
91742315|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.26|0.41||||||Day 57 Cohort C: TIP/PBO, Pooled PBO||0.41|-3.26|
91742316|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-3.98|-1.25||||||Day 57: Pooled TIP, Pooled PBO||-1.25|-3.98|
91742317|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.5|0.19||||||Day 57: Pooled TIP/PBO, Pooled PBO||0.19|-2.50|
91742318|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-4.0|-0.38||||||Day 85 Cohort A: TIP, Pooled PBO||-0.38|-4.00|
91742319|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.81|0.13||||||Day 85 Cohort A: TIP/PBO, Pooled PBO||0.13|-3.81|
91742320|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-4.96|-0.53||||||Day 85 Cohort B: TIP, Pooled PBO||-0.53|-4.96|
91742321|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-5.44|-1.73||||||Day 85 Cohort B: TIP/PBO, Pooled PBO||-1.73|-5.44|
91742322|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-4.9|-1.07||||||Day 85 Cohort C: TIP, Pooled PBO||-1.07|-4.90|
91742323|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.66|-0.53||||||Day 85 Cohort C: TIP/PBO, Pooled PBO||-0.53|-4.66|
91742324|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-4.11|-1.17||||||Day 85: Pooled TIP, Pooled PBO||-1.17|-4.11|
91742325|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-4.12|-1.23||||||Day 85: Pooled TIP/PBO, Pooled PBO||-1.23|-4.12|
91742326|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-4.55|-1.08||||||Day 113 Cohort A: TIP, Pooled PBO||-1.08|-4.55|
91742327|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-1.61|1.71||||||Day 113 Cohort A: TIP/PBO, Pooled PBO||1.71|-1.61|
91742328|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-4.93|-0.29||||||Day 113 Cohort B: TIP, Pooled PBO||-0.29|-4.93|
91742329|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-3.62|-0.25||||||Day 113 Cohort B: TIP/PBO, Pooled PBO||-0.25|-3.62|
91742330|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-4.94|-1.3||||||Day 113 Cohort C: TIP, Pooled PBO||-1.30|-4.94|
91742331|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-4.37|-0.43||||||Day 113 Cohort C: TIP/PBO, Pooled PBO||-0.43|-4.37|
91742332|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.24|-1.45||||||Day 113: Pooled TIP, Pooled PBO||-1.45|-4.24|
91742333|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-2.73|-0.13||||||Day 113: Pooled TIP/PBO, Pooled PBO||-0.13|-2.73|
91742334|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.64|-0.73||||||EoT Cohort A: TIP, Pooled PBO||-0.73|-3.64|
91742335|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.61|1.43||||||EoT Cohort A: TIP/PBO, Pooled PBO||1.43|-1.61|
91500088|NCT02636868|182870283|SUPERIORITY|||||||0.461||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.461
91742336|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.81|0.25||||||EoT Cohort B: TIP, Pooled PBO||0.25|-2.81|
91742337|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.14|-0.22||||||EoT Cohort B: TIP/PBO, Pooled PBO||-0.22|-3.14|
91742338|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.89|-0.98||||||EoT Cohort C: TIP, Pooled PBO||-0.98|-3.89|
91742339|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.12|-0.22||||||EoT Cohort C: TIP/PBO, Pooled PBO||-0.22|-3.12|
91742340|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.0|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.08|-0.85||||||EoT: Pooled TIP, Pooled PBO||-0.85|-3.08|
91742341|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.25|-0.04||||||EoT: Pooled TIP/PBO, Pooled PBO||-0.04|-2.25|
91742342|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.8|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-2.63|0.99||||||Day 141 Cohort A: TIP, Pooled PBO||0.99|-2.63|
91742343|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-1.83|1.98||||||Day 141 Cohort A: TIP/PBO, Pooled PBO||1.98|-1.83|
91742344|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|0.2|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-2.03|2.41||||||Day 141 Cohort B: TIP, Pooled PBO||2.41|-2.03|
91742345|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.68|-0.01||||||Day 141 Cohort B: TIP/PBO, Pooled PBO||-0.01|-3.68|
91742346|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.9|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.78|1.07||||||Day 141 Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||1.07|-2.78|
91742347|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-3.36|0.89||||||Day 141 Cohort C: TIP/PBO, Pooled PBO||0.89|-3.36|
91742348|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.97|0.98||||||Day 141: Pooled TIP, Pooled PBO||0.98|-1.97|
91742349|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.45|0.45||||||Day 141: Pooled TIP/PBO, Pooled PBO||0.45|-2.45|
91742350|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.24|0.61||||||Day 169 Cohort A: TIP, Pooled PBO||0.61|-3.24|
91742351|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.05|0.91||||||Day 169 Cohort A: TIP/PBO, Pooled PBO||0.91|-3.05|
91742352|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.6|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-2.73|1.62||||||Day 169 Cohort B: TIP, Pooled PBO||1.62|-2.73|
91742353|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.22|-0.08||||||Day 169 Cohort B: TIP/PBO, Pooled PBO||-0.08|-4.22|
91742354|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.2|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-2.48|2.1||||||Day 169 Cohort C: TIP, Pooled PBO||2.10|-2.48|
91742355|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-2.33|2.13||||||Day 169 Cohort C: TIP/PBO, Pooled PBO||2.13|-2.33|
91742356|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.7|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.24|0.86||||||Day 169: Pooled TIP, Pooled PBO||0.86|-2.24|
91742357|NCT02712983|183378478|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.61|0.4||||||Day 169: Pooled TIP/PBO, Pooled PBO||0.40|-2.61|
91742358|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.14|3.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.18|0.14|
91742359|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.18|1.85|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.85|0.18|
91500089|NCT02636868|182870284|SUPERIORITY|||||||0.401||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.401
91500090|NCT02636868|182870284|SUPERIORITY|||||||0.372||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.372
91500091|NCT02636868|182870284|SUPERIORITY|||||||0.648||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.648
91500092|NCT02636868|182870285|SUPERIORITY|||||||0.996||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference across treatments||||0.996
91500093|NCT02636868|182870285|SUPERIORITY|||||||0.951||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.951
91742360|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.42|3.77|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.77|0.42|
91742361|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.2|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||1.83|0.20|
91500094|NCT02636868|182870285|SUPERIORITY|||||||0.995||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.995
91500095|NCT02636868|182870286|SUPERIORITY|||||||0.312||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.312
91500096|NCT02636868|182870286|SUPERIORITY|||||||0.094||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.094
91500097|NCT02636868|182870286|SUPERIORITY|||||||0.414||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model.||Null hypothesis of no difference between treatment groups||||0.414
91500098|NCT02636868|182870287|SUPERIORITY|||||||0.099||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO2) in model||Null hypothesis of no difference between treatment groups||||0.099
91742362|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.21|2.17|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||2.17|0.21|
91500099|NCT02636868|182870287|SUPERIORITY|||||||0.09||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatments||||0.090
91500100|NCT02636868|182870287|SUPERIORITY|||||||0.461||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatment groups||||0.461
91500101|NCT02636868|182870288|SUPERIORITY|||||||0.534||||||A priori threshold for statistical significance set at 0.05|ANOVA|treatment and pooled site in model||Null hypothesis of no treatment between treatments||||0.534
91500102|NCT02636868|182870288|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.480
91500103|NCT02636868|182870288|SUPERIORITY|||||||0.313||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.313
91500104|NCT02127567|182870301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.7|||Mixed Models Analysis|||||2.7|1.5|<0.001
91500105|NCT02127567|182870302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.01|TWO_SIDED|95.0|1.1|4.4|||Mixed Models Analysis|||||4.4|1.1|<0.01
91500106|NCT02127567|182870303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.44|TWO_SIDED|95.0|-0.7|2.0|||Mixed Models Analysis|||||2.0|-0.7|0.44
91500107|NCT02127567|182870304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.01|TWO_SIDED|95.0|0.8|3.6|||Mixed Models Analysis|||||3.6|0.8|<0.01
91500108|NCT02127567|182870305|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.8|||<|0.01|TWO_SIDED|95.0|0.7|2.9|||Mixed Models Analysis|||||2.9|0.7|<0.01
91500109|NCT02127567|182870306|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.78|TWO_SIDED|95.0|-2.0|1.3|||Mixed Models Analysis|||||1.3|-2.0|0.78
91500110|NCT02127567|182870307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.01|TWO_SIDED|95.0|4.1|6.7|||Mixed Models Analysis|||||6.7|4.1|<0.01
91742363|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.44|3.62|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||3.62|0.44|
91742364|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.44|2.23|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||2.23|0.44|
91742365|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.34|1.71|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.71|0.34|
91500111|NCT02127567|182870308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.002|TWO_SIDED|95.0|0.5|2.3|||Mixed Models Analysis|||||2.3|0.5|0.002
91742366|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.08|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||1.83|0.08|
91742367|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.25|2.89|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.89|0.25|
91742368|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.25|3.93|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.93|0.25|
91742369|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.19|2.36|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.36|0.19|
91742370|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.19|||||TWO_SIDED|95.0|0.02|1.57|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.57|0.02|
91742371|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.16|2.41|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||2.41|0.16|
91742372|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.13|1.31|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.31|0.13|
91500112|NCT03182829|182870309|NON_INFERIORITY|non-inferiority was chosen|Mean Difference (Final Values)|100.0|||<|0.05|TWO_SIDED|95.0|90.0|100.0|||Chi-squared||||Fisher's exact test|100|90|<0.05
91500113|NCT03316131|182870310|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-8.67|9.22||||||||9.22|-8.67|
91500114|NCT03316131|182870311|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|90.0|1.03|1.25||||||Treatment A/Treatment B, for Verinurad||1.25|1.03|
91742373|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.8|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||1.80|0.28|
91742374|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|10.71|||||TWO_SIDED|95.0|1.1|104.19|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||104.19|1.10|
91742375|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|4.62|||||TWO_SIDED|95.0|0.41|52.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||52.29|0.41|
91742376|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|3.23|||||TWO_SIDED|95.0|0.28|37.06|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||37.06|0.28|
91742377|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.1|25.94|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||25.94|0.10|
91742378|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|11.3|||||TWO_SIDED|95.0|1.09|117.34|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||117.34|1.09|
91742379|NCT02712983|183378479|OTHER||Hazard Ratio (HR)|4.3|||||TWO_SIDED|95.0|0.5|37.32|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Pooled TIP, Pooled PBO||37.32|0.50|
91742380|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|9.8|STANDARD_ERROR_OF_MEAN|18.15|||TWO_SIDED|95.0|-27.15|46.81|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP, Pooled PBO||46.81|-27.15|
91742381|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|19.8|STANDARD_ERROR_OF_MEAN|20.81|||TWO_SIDED|95.0|-22.63|62.14|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP/PBO, Pooled PBO||62.14|-22.63|
91742382|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|8.0|STANDARD_ERROR_OF_MEAN|19.29|||TWO_SIDED|95.0|-31.32|47.26|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP, Pooled PBO||47.26|-31.32|
91742383|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|12.7|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|95.0|-26.49|51.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP/PBO, Pooled PBO||51.89|-26.49|
91742384|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|46.5|STANDARD_ERROR_OF_MEAN|21.17|||TWO_SIDED|95.0|3.37|89.61|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP, Pooled PBO||89.61|3.37|
91742385|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|3.2|STANDARD_ERROR_OF_MEAN|18.37|||TWO_SIDED|95.0|-34.21|40.64|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP/PBO, Pooled PBO||40.64|-34.21|
91742386|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|21.4|STANDARD_ERROR_OF_MEAN|14.46|||TWO_SIDED|95.0|-8.03|50.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP, Pooled PBO||50.89|-8.03|
91742387|NCT02712983|183378480|OTHER||LS Mean Diff (SE) vs pooled placebo|11.9|STANDARD_ERROR_OF_MEAN|14.44|||TWO_SIDED|95.0|-17.52|41.29|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP/PBO, Pooled PBO||41.29|-17.52|
91742388|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.51|3.13|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.13|0.51|
91742389|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.15|1.46|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.46|0.15|
91500115|NCT03316131|182870311|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.88|1.07||||||Treatment A/Treatment B, for M1||1.07|0.88|
91500116|NCT03316131|182870311|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08||||||Treatment A/Treatment B, for M8||1.08|0.91|
91500117|NCT03316131|182870312|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
91500118|NCT03316131|182870312|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
91500119|NCT03316131|182870312|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
91500120|NCT03316131|182870316|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
91500121|NCT03316131|182870316|OTHER||Geometric mean ratio|0.96||||||90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
91500122|NCT03316131|182870316|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
91500123|NCT02664441|182870317|SUPERIORITY||Mean Difference (Net)|-1.7||||0.4|TWO_SIDED|95.0|-4.1|0.6|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||0.6|-4.1|0.40
91500124|NCT02664441|182870318|SUPERIORITY||Mean Difference (Net)|-3.1||||0.02|TWO_SIDED|95.0|-5.7|-0.4|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||-0.4|-5.7|0.02
91500125|NCT02664441|182870319|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.032|TWO_SIDED|95.0|-37.8|-2.7|||Regression, Linear|Adjusted for baseline values||Analysis for Fat Intake||-2.7|-37.8|.032
91742390|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.21|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.21|0.44|
91742391|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.32|2.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||2.18|0.32|
91742392|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.1|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||1.27|0.10|
91742393|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.43|2.99|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||2.99|0.43|
91742394|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.76|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||1.76|0.37|
91742395|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.36|1.61|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.61|0.36|
91742396|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.3|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||2.55|0.30|
91742397|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.2|2.03|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.03|0.20|
91742398|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.4|3.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.60|0.40|
91742399|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.31|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.55|0.31|
91500126|NCT02664441|182870319|SUPERIORITY||Mean Difference (Net)|-430.0||||0.02|TWO_SIDED|95.0|-761.0|-100.0|||Regression, Linear|Adjusted for baseline values||Analysis for Total Calorie Intake||-100|-761|.02
91500127|NCT02664441|182870320|SUPERIORITY||Geometric Mean Ratio|1.42||||0.19|TWO_SIDED|95.0|0.97|2.08|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.08|0.97|0.19
91500128|NCT02664441|182870321|SUPERIORITY||Geometric Mean Ratio|1.0||||0.82|TWO_SIDED|95.0|0.91|1.11|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for HDL Cholesterol||1.11|0.91|0.82
91500129|NCT02664441|182870321|SUPERIORITY||Geometric Mean Ratio|1.0||||0.92|TWO_SIDED|95.0|0.83|1.19|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for Triglycerides||1.19|0.83|0.92
91500130|NCT02664441|182870322|SUPERIORITY||Geometric Mean Ratio|0.62||||0.03|TWO_SIDED|95.0|0.41|0.92|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||0.92|0.41|0.03
91742400|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.06|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.27|0.06|
91500131|NCT02664441|182870323|SUPERIORITY||Geometric Mean Ratio|1.39||||0.32|TWO_SIDED|95.0|0.9|2.14|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.14|0.90|0.32
91500132|NCT02664441|182870324|SUPERIORITY||Geometric Mean Ratio|0.95||||0.69|TWO_SIDED|95.0|0.81|1.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals.|||1.10|0.81|0.69
91500133|NCT02664441|182870325|SUPERIORITY||Mean Difference (Net)|-166.4||||0.004|TWO_SIDED|95.0|-269.7|-63.1|||Regression, Linear|Adjusted for baseline values||||-63.1|-269.7|0.004
91500134|NCT02664441|182870326|SUPERIORITY||Mean Difference (Net)|-145.0||||0.58|TWO_SIDED|95.0|-653.5|363.4|||Regression, Linear|Adjusted for baseline||||363.4|-653.5|0.58
91500135|NCT02664441|182870327|SUPERIORITY||Mean Difference (Net)|-8.5||||0.088|TWO_SIDED|95.0|-19.1|2.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||2.1|-19.1|0.088
91500136|NCT02560584|182870328|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for a single propor|||"The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.~Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients"||||<0.0001
91742401|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.45|3.73|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||3.73|0.45|
91742402|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.27|1.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.60|0.27|
91742403|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.4|2.02|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||2.02|0.40|
91742404|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|3.72|||||TWO_SIDED|95.0|0.84|16.52|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||16.52|0.84|
91742405|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.22|8.16|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||8.16|0.22|
91742406|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|0.46|10.05|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||10.05|0.46|
91742407|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.05|4.87|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||4.87|0.05|
91500137|NCT02560584|182870330|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for single proporti|||"The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).~Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients."||||<0.0001
91742408|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|2.56|||||TWO_SIDED|95.0|0.53|12.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||12.49|0.53|
91742409|NCT02712983|183378485|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.33|5.68|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Paremteral Pooled TIP, Pooled PBO||5.68|0.33|
91742410|NCT02712983|183378490|OTHER||Odds Ratio, log|5.62|||||TWO_SIDED|95.0|0.83|38.18|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||38.18|0.83|
91742411|NCT02712983|183378490|OTHER||Odds Ratio, log|2.0|||||TWO_SIDED|95.0|0.21|19.16|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||19.16|0.21|
91500138|NCT03518073|182870368|SUPERIORITY||Posterior Mean Ratio|1.1|||||TWO_SIDED|95.0|0.959|1.265|||||Posterior mean ratio with 95% credible interval is reported.|||1.265|0.959|
91500139|NCT03518073|182870368|SUPERIORITY||Posterior Mean Ratio|1.05|||||TWO_SIDED|95.0|0.907|1.209|||||Posterior mean ratio with 95% credible interval is reported.|||1.209|0.907|
91500140|NCT03518073|182870369|SUPERIORITY||Posterior Mean Ratio|1.11|||||TWO_SIDED|95.0|0.943|1.29|||||Posterior mean ratio with 95% credible interval is reported.|||1.290|0.943|
91500141|NCT03518073|182870369|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.737|1.053|||||Posterior mean ratio with 95% credible interval is reported.|||1.053|0.737|
91500142|NCT03518073|182870370|SUPERIORITY||Posterior Mean Ratio|1.06|||||TWO_SIDED|95.0|0.873|1.284|||||Posterior mean ratio with 95% credible interval is reported.|||1.284|0.873|
91742412|NCT02712983|183378490|OTHER||Odds Ratio, log|3.05|||||TWO_SIDED|95.0|0.43|21.8|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||21.80|0.43|
91742413|NCT02712983|183378490|OTHER||Odds Ratio, log|1.84|||||TWO_SIDED|95.0|0.19|17.42|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||17.42|0.19|
91742414|NCT02712983|183378490|OTHER||Odds Ratio, log|3.41|||||TWO_SIDED|95.0|0.47|25.03|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||25.03|0.47|
91742415|NCT02712983|183378490|OTHER||Odds Ratio, log|2.74|||||TWO_SIDED|95.0|0.47|16.07|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|||16.07|0.47|
91742416|NCT02712983|183378491|OTHER||Hazard Ratio (HR)|4.5|||||TWO_SIDED|95.0|0.77|26.42|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||26.42|0.77|
91742417|NCT02712983|183378491|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.28|14.47|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||14.47|0.28|
91742418|NCT02712983|183378491|OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.2|11.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||11.60|0.20|
91742419|NCT02712983|183378491|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.06|7.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||7.49|0.06|
91742420|NCT02712983|183378491|OTHER||Hazard Ratio (HR)|3.81|||||TWO_SIDED|95.0|0.62|23.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||23.29|0.62|
91742421|NCT02712983|183378491|OTHER||Hazard Ratio (HR)|1.82|||||TWO_SIDED|95.0|0.35|9.45|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Pooled TIP, Pooled PBO||9.45|0.35|
91742422|NCT03308968|183378618|OTHER||Least square (LS) mean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.84|-2.42|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.42|-3.84|<0.0001
91500143|NCT03518073|182870370|SUPERIORITY||Posterior Mean Ratio|1.21|||||TWO_SIDED|95.0|1.006|1.453|||||Posterior mean ratio with 95% credible interval is reported.|||1.453|1.006|
91500144|NCT03518073|182870371|SUPERIORITY||Posterior Mean Ratio|1.12|||||TWO_SIDED|95.0|0.963|1.3|||||Posterior mean ratio with 95% credible interval is reported.|||1.300|0.963|
91500145|NCT03518073|182870371|SUPERIORITY||Posterior Mean Ratio|0.95|||||TWO_SIDED|95.0|0.805|1.119|||||Posterior mean ratio with 95% credible interval is reported.|||1.119|0.805|
91500146|NCT03518073|182870372|SUPERIORITY||Posterior Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.221|||||Posterior mean ratio with 95% credible interval is reported.|||1.221|0.880|
91500147|NCT03518073|182870372|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.742|1.065|||||Posterior mean ratio with 95% credible interval is reported.|||1.065|0.742|
91500148|NCT03518073|182870373|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.253|TWO_SIDED|95.0|-0.01|0.05|||Mixed Models Analysis|||||0.05|-0.01|0.253
91500149|NCT03518073|182870373|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.354|TWO_SIDED|95.0|-0.02|0.05|||Mixed Models Analysis|||||0.05|-0.02|0.354
91742423|NCT03308968|183378618|OTHER||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-4.19|-2.78|||ANCOVA|||Analysis was performed using ANCOVA method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.78|-4.19|<0.0001
91500150|NCT03518073|182870374|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|1.554||0.691|TWO_SIDED|95.0|-2.44|3.68|||Mixed Models Analysis|||||3.68|-2.44|0.691
91500151|NCT03518073|182870374|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.599||0.749|TWO_SIDED|95.0|-2.64|3.66|||Mixed Models Analysis|||||3.66|-2.64|0.749
91500152|NCT03045081|182870377|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. GEE allows for the analysis of repeated measures with unknown covariance structure and uses all available data that participants provide, even if follow-up data are missing (ie, intent-to-treat analysis). Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; i.e., as treated 'completer' analysis) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in pain self efficacy over time compared to the usual care group.||||<0.05
91500153|NCT03045081|182870377|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain self-efficacy over time compared to the usual care group. This analysis was limited to those participants who provided data at each of the study time points ('completer analysis').||||<0.05
91500154|NCT03045081|182870378|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; 'study completers') were evaluated (see Statistical Analysis 2).||||||0.068||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group. Note: this questionnaire has 2 subscales, Activity Engagement and Pain Willingness. Intent-to-treat and as treated analyses were conducted for each subscale.||||0.068
91500155|NCT03045081|182870378|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \<0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group.This analysis was limited to those participants who provided data at each of the study time points ('completer' analysis).||||<0.05
91742424|NCT01521923|183378649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.719|||=|0.112|TWO_SIDED|95.0|0.881|3.354|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level||3.354|0.881|=0.112
91500156|NCT03045081|182870378|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.||||||0.173||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group.||||0.173
91705231|NCT02607306|183304968|SUPERIORITY|Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.|Treatment contrast|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.37||p-value for superiority of IDegLira vs Lira is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.37|-0.60|<0.0001
91705232|NCT02607306|183304969|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-1.19||||0.0001|TWO_SIDED|95.0|-1.8|-0.59||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.||-0.59|-1.80|0.0001
91705233|NCT02607306|183304970|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|0.48|||<|0.0001|TWO_SIDED|95.0|0.35|0.68||p-value for superiority of IDegLira vs IDeg is presented|Negative binomial regression|||The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.||0.68|0.35|<0.0001
91705234|NCT02607306|183304971|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
91705235|NCT03240406|183305008|SUPERIORITY||Mean Difference (Net)|-0.06||||0.259|TWO_SIDED|95.0|-0.15|0.04||Test of the between arm difference in the global composite at Burst 2, adjusted for the study arm, baseline (Burst 1) global composite, and the randomization stratification factors (baseline sex, age, and years of education)|ANCOVA|ANCOVA of Burst 2 composite adjusted for arm, Burst 1 composite, sex, age, and education. Missing/invalid data were multiply imputed using MICE|Mean Difference of MHD Arm compared to control|||0.04|-0.15|0.259
91705236|NCT03240406|183305009|SUPERIORITY||Mean Difference (Net)|-0.64||||0.001|TWO_SIDED|95.0|-1.02|-0.27||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.27|-1.02|0.001
91705237|NCT03240406|183305010|SUPERIORITY||Mean Difference (Net)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.34|-0.54||Estimated from ANCOVA model adjusted for baseline value, age, sex, and years of education at baseline.|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education.|Mean Difference of MHD Arm vs Comparison Arm|||-0.54|-1.34|<0.001
91705238|NCT03240406|183305011|SUPERIORITY||Mean Difference (Net)|0.24||||0.904|TWO_SIDED|95.0|-3.63|4.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.11|-3.63|0.904
91705239|NCT03240406|183305012|SUPERIORITY||Mean Difference (Net)|-0.12||||0.721|TWO_SIDED|95.0|-0.76|0.52||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; tocopherol biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.52|-0.76|0.721
91705240|NCT03240406|183305013|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.01|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; carotenoid biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.01|-0.01|0.769
91705241|NCT03240406|183305014|SUPERIORITY||Mean Difference (Net)|-1.37||||0.978|TWO_SIDED|95.0|-100.13|97.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||97.4|-100.13|0.978
91742425|NCT01521923|183378649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.889|||=|0.041|TWO_SIDED|95.0|1.026|3.48|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level||3.480|1.026|=0.041
91742426|NCT03037476|183378687|OTHER|General Linear Model|Slope|-0.235||||0.03|TWO_SIDED|95.0|-0.446|-0.023|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 6 Month Follow-up Outcomes reported in this section.||-.023|-.446|0.03
91742427|NCT03037476|183378687|OTHER|General Linear Model|Slope|-0.149||||0.164|TWO_SIDED|95.0|-0.36|0.061|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 12 Month Follow-up reported in this section.||.061|-.360|0.164
91742428|NCT03037476|183378688|OTHER|General Linear Model|Slope|-0.24||||0.603|TWO_SIDED|95.0|-1.12|0.65|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 6 Month Followup||.650|-1.120|.603
91742429|NCT03037476|183378688|OTHER|General Linear Model|Slope|-0.336||||0.465|TWO_SIDED|95.0|-1.238|0.566|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followup||.566|-1.238|.465
91742430|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.059||||0.486|TWO_SIDED|95.0|-0.227|0.108|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 6 Month Followup||.108|-.227|.486
91742431|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.006||||0.942|TWO_SIDED|95.0|-0.16|0.172|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followup||.172|-.160|.942
91742432|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.042||||0.552|TWO_SIDED|95.0|-0.18|0.097|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followup||.097|-.180|.552
91742433|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.037||||0.608|TWO_SIDED|95.0|-0.104|0.177|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followup||.177|-.104|.608
91742434|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.015||||0.84|TWO_SIDED|95.0|-0.13|0.16|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followup||.160|-.130|.840
91742435|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.007||||0.927|TWO_SIDED|95.0|-0.142|0.155|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followup||.155|-.142|.927
91742436|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.01||||0.932|TWO_SIDED|95.0|-0.244|0.223|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||.223|-.244|.932
91742437|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.057||||0.648|TWO_SIDED|95.0|-0.3|0.187|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||0.187|-.300|.648
91742438|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.059||||0.702|TWO_SIDED|95.0|-0.363|0.245|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followup||.245|-.363|.702
91742439|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.1||||0.524|TWO_SIDED|95.0|-0.408|0.208|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followup||.208|-.408|.524
91742440|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.008||||0.913|TWO_SIDED|95.0|-0.137|0.153|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followup||.153|-.137|.913
91742441|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.032||||0.676|TWO_SIDED|95.0|-0.117|0.181|||Mixed Models Analysis|Poisson Regresision||Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followup||.181|-.117|.676
91742442|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.035||||0.712|TWO_SIDED|95.0|-0.223|0.152|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followup||.152|-.223|.712
91742443|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.005||||0.956|TWO_SIDED|95.0|-0.186|0.197|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followup||0.197|-.186|.956
91742444|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.149||||0.446|TWO_SIDED|95.0|-0.234|0.531|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followup||.531|-.234|.446
91742445|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.055||||0.793|TWO_SIDED|95.0|-0.353|0.462|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followup||.462|-.353|.793
91742446|NCT03037476|183378689|OTHER|General Linear Model|Slope|-0.001||||0.999|TWO_SIDED|95.0|-2.005|2.003|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 6 Month Followup||2.003|-2.005|.999
91742447|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.999||||0.397|TWO_SIDED|95.0|-1.312|3.31|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 12 Month Followup||3.310|-1.312|.397
91742448|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.465||||0.303|TWO_SIDED|95.0|-0.419|1.349|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||1.349|-.419|.303
91742449|NCT03037476|183378689|OTHER|General Linear Model|Slope|0.939|||<|0.05|TWO_SIDED|95.0|0.128|1.751|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||1.751|.128|<.05
91742450|NCT03037476|183378690|OTHER|General Linear Model|Slope|-0.1816||||0.151|TWO_SIDED|95.0|-0.4295|0.0663|||Mixed Models Analysis|Negative binomial regression||Change in ASSIST Score over time: 6 month follow up||0.0663|-0.4295|0.151
91742451|NCT03037476|183378690|OTHER|General Linear Model|Slope|-0.0601||||0.642|TWO_SIDED|95.0|-0.3133|0.1931|||Mixed Models Analysis|Negative Binomial Regression||Changes in ASSIST scores at 12 month follow up||0.1931|-0.3133|0.642
91500157|NCT03045081|182870378|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.167||||||Wald χ2 \>0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.167
91500158|NCT03045081|182870379|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.176||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group.||||0.176
91500159|NCT03045081|182870379|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.143||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.143
91500160|NCT03045081|182870380|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group.||||<0.05
91500161|NCT03045081|182870380|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.001||||||Wald χ2 \< 0.05 were considered statistically significant for the group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points (i.e., 'completer' analysis).||||<0.001
91500162|NCT03045081|182870382|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.102||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group.||||0.102
91500163|NCT03045081|182870382|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each time point (as treated, 'completer' analysis).||||<0.05
91500164|NCT02436889|182870396|SUPERIORITY|||||||0.949|||||||ANCOVA|||||||0.949
91500165|NCT02436889|182870397|SUPERIORITY||Mean Difference (Final Values)|3.11||||0.2415|TWO_SIDED|95.0|-2.09|8.31|||ANCOVA|change from baseline, adjusted for baseline value||||8.31|-2.09|0.2415
91705242|NCT03240406|183305015|SUPERIORITY||Mean Difference (Net)|0.15||||0.395|TWO_SIDED|95.0|-0.2|0.51||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Monounsaturated Fat||0.51|-0.2|0.395
91500166|NCT02436889|182870398|SUPERIORITY||Mean Difference (Final Values)|-12.01||||0.0001|TWO_SIDED|95.0|-18.16|-5.87|||ANCOVA|||||-5.87|-18.16|0.0001
91500167|NCT02436889|182870399|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.1956|TWO_SIDED|95.0|-1.59|0.33|||ANCOVA|||||0.33|-1.59|0.1956
91500168|NCT02436889|182870400|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.0168|TWO_SIDED|95.0|0.34|3.4|||ANCOVA|||||3.40|0.34|0.0168
91500169|NCT02436889|182870401|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0101|TWO_SIDED|95.0|0.5|3.71|||ANCOVA|||||3.71|0.50|0.0101
91500170|NCT01034462|182870402|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.095||||0.0051|TWO_SIDED|95.0|-5.256|-0.935|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.935|-5.256|0.0051
91500171|NCT01034462|182870403|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.632||||0.001|TWO_SIDED|95.0|-4.193|-1.07|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.070|-4.193|0.0010
91500172|NCT00303498|182870445|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|43.0||||0.0302|||||||ANCOVA|Change at Week 24: P-value was obtained from the non-parametric analysis of covariance (ANCOVA) controlling for baseline treadmill exercise time.||The median of the treatment difference was calculated using the Hodges-Lehmann estimator.||||0.0302
91500173|NCT00303498|182870446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.495|||||||ANCOVA|Change at Week 24: P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.4950
91500174|NCT00303498|182870447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.6||||0.3874|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PLAX 2D mode||||0.3874
91742452|NCT03037476|183378691|OTHER|General Linear Model|Slope|-0.2177||||0.074|TWO_SIDED|95.0|-0.4566|0.0213|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 6 month follow up||0.0213|-0.4566|0.074
91500175|NCT00303498|182870447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.8||||0.7038|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PSAX M-mode||||0.7038
91742453|NCT03037476|183378691|OTHER|General Linear Model|Slope|-0.1165||||0.351|TWO_SIDED|95.0|-0.3612|0.1282|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 12 month follow up||0.1282|-0.3612|0.351
91742454|NCT03037476|183378692|OTHER|General Linear Model|Slope|0.044||||0.255|TWO_SIDED|95.0|-0.032|0.1197|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity at 6 months (reported by number of standard drinks)||0.1197|-0.032|0.255
91742455|NCT03037476|183378692|OTHER|General Linear Model|Slope|0.0315||||0.428|TWO_SIDED|95.0|-0.0463|0.1092|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-up||0.1092|-0.0463|0.428
91742456|NCT03037476|183378693|OTHER|General Linear Model|Slope|0.0021||||0.966|TWO_SIDED|95.0|-0.0936|0.0978|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 6 months||0.0978|-0.0936|0.966
91742457|NCT03037476|183378693|OTHER|General Linear Model|Slope|-0.0559||||0.265|TWO_SIDED|95.0|-0.1542|0.0424|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 12 month follow-up||0.0424|-0.1542|0.265
91742458|NCT03037476|183378694|OTHER|General Linear Model|Slope|-0.0128||||0.868|TWO_SIDED|95.0|-0.1633|0.1378|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 6 month follow-up||0.1378|-0.1633|0.868
91742459|NCT03037476|183378694|OTHER|General Linear Model|Slope|-0.0445||||0.573|TWO_SIDED|95.0|-0.1993|0.1102|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 12 month follow-up||0.1102|-0.1993|0.573
91500176|NCT00303498|182870448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.9||||0.8998|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8998
91500177|NCT00303498|182870449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7||||0.7245|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.7245
91500178|NCT00303498|182870450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.8649|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8649
91742460|NCT03037476|183378695|OTHER|General Linear Model|Slope|-0.0899||||0.266|TWO_SIDED|95.0|-0.2484|0.0685|||Mixed Models Analysis|Negative Binomial Regression||Change in past 12 month marijuana use at 6 month follow-up||0.0685|-0.2484|0.266
91742461|NCT03037476|183378695|OTHER|General Linear Model|Slope|-0.0197||||0.816|TWO_SIDED|95.0|-0.1859|0.1465|||Mixed Models Analysis|Negative Binomial Regression||Past 12 month marijuana use at 12 month follow-up||0.1465|-0.1859|0.816
91742462|NCT03037476|183378695|OTHER|General Linear Model|Slope|-0.1031||||0.209|TWO_SIDED|95.0|-0.2639|0.0577|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 6 month follow-up||0.0577|-0.2639|0.209
91742463|NCT03037476|183378695|OTHER|General Linear Model|Slope|-0.006||||0.944|TWO_SIDED|95.0|-0.1729|0.1608|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 12 month follow-up||0.1608|-0.1729|0.944
91742464|NCT03037476|183378695|OTHER|General Linear Model|Slope|-0.0391||||0.654|TWO_SIDED|95.0|-0.2102|0.132|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 6 month follow-up||0.1320|-0.2102|0.654
91742465|NCT03037476|183378695|OTHER|General Linear Model|Slope|-0.0646||||0.481|TWO_SIDED|95.0|-0.2444|0.1152|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 12 month follow-up||0.1152|-0.2444|0.481
91742466|NCT03037476|183378696|OTHER|General Linear Model|Slope|-0.0411||||0.487|TWO_SIDED|95.0|-0.1569|0.0747|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 6 month follow-up||0.0747|-0.1569|0.487
91742467|NCT03037476|183378696|OTHER|General Linear Model|Slope|0.0177||||0.772|TWO_SIDED|95.0|-0.1021|0.1375|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 12 month follow-up||0.1375|-0.1021|0.772
91742468|NCT03037476|183378697|OTHER|General Linear Model|Slope|0.1285||||0.075|TWO_SIDED|95.0|-0.0131|0.2702|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 6 month follow up||0.2702|-0.0131|0.075
91742469|NCT03037476|183378697|OTHER|General Linear Model|Slope|0.0936||||0.207|TWO_SIDED|95.0|-0.0517|0.2388|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 12 month follow up||0.2388|-0.0517|0.207
91742470|NCT03037476|183378698|OTHER|General Linear Model|Slope|-0.1604|||<|0.001|TWO_SIDED|95.0|-0.2525|-0.0683|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (in perceived days of use in past year) at 6 month follow up||-0.0683|-0.2525|<0.001
91742471|NCT03037476|183378698|OTHER|General Linear Model|Slope|-0.1441|||<|0.003|TWO_SIDED|95.0|-0.2404|-0.0478|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (perceived number of days of use in past year) at 12 month follow up||-0.0478|-0.2404|<.003
91742472|NCT03037476|183378699|OTHER|General Linear Model|Slope|-0.0157||||0.743|TWO_SIDED|95.0|-0.1096|0.0782|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 6 month follow-up||0.0782|-0.1096|0.743
91742473|NCT03037476|183378699|OTHER|General Linear Model|Slope|0.0133||||0.784|TWO_SIDED|95.0|-0.0816|0.1081|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 12 month follow up||0.1081|-0.0816|0.784
91742474|NCT03037476|183378700|OTHER|General Linear Model|Slope|-0.0061||||0.914|TWO_SIDED|95.0|-0.1161|0.104|||Mixed Models Analysis|Poisson regression||Change in cumulative grade point average at 6 month follow up||0.104|-0.1161|0.914
91742475|NCT03037476|183378700|OTHER|General Linear Model|Slope|-0.0092||||0.871|TWO_SIDED|95.0|-0.1202|0.1018|||Mixed Models Analysis|General Linear Model||Change in cumulative grade point average at 12 month follow up||0.1018|-0.1202|0.871
91742476|NCT03037476|183378700|OTHER|General Linear Model|Slope|0.003||||0.957|TWO_SIDED|95.0|-0.1063|0.1124|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 6 month follow-up||0.1124|-0.1063|0.957
91742477|NCT03037476|183378700|OTHER|General Linear Model|Slope|0.0006||||0.992|TWO_SIDED|95.0|-0.1098|0.1109|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 12 month follow-up||0.1109|-0.1098|0.992
91742478|NCT03037476|183378701|OTHER|General Linear Model|Slope|0.039||||0.447|TWO_SIDED|95.0|-0.0615|0.1395|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 6 month follow-up||0.1395|-.0615|0.447
91742479|NCT03037476|183378701|OTHER|General Linear Model|Slope|0.0398||||0.443|TWO_SIDED|95.0|-0.0619|0.1414|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 12 month follow-up||0.1414|-0.0619|0.443
91742480|NCT03037476|183378702|OTHER|General Linear Model|Slope|0.0002||||0.997|TWO_SIDED|95.0|-0.1066|0.107|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol typical quantity at 6 months||0.1070|-0.1066|0.997
91742481|NCT03037476|183378702|OTHER|General Linear Model|Slope|-0.0136||||0.808|TWO_SIDED|95.0|-0.1236|0.0963|||Mixed Models Analysis|Negative Binomial Regression||Change in past month typical alcohol quantity at 12 month follow-up||0.0963|-0.1236|0.808
91742482|NCT02403817|183378705|OTHER|This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).||||||5e-05|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.00005
91742483|NCT02403817|183378706|OTHER|||||||0.018|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.018
91742484|NCT00501592|183378715|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 25 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.040
91500179|NCT00303498|182870451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5909||||||The statistical analysis (P value) was performed on the composite change for all categories.|Cochran-Mantel-Haenszel|||Change at Week 24||||0.5909
91513598|NCT03893448|182899001|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-7.8|-1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.3|-7.8|< 0.001
91742485|NCT00501592|183378715|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 50 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.28
91742486|NCT00501592|183378716|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||t-test, 2 sided|||||||0.0031
91742487|NCT00501592|183378716|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
91742488|NCT00501592|183378716|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
91742489|NCT00501592|183378716|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
91742490|NCT04474197|183378721|SUPERIORITY||Least Squares (LS) Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.5|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.5|<0.0001
91742491|NCT04474197|183378721|SUPERIORITY||LS Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.6|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.6|<0.0001
91742492|NCT04474197|183378721|SUPERIORITY||LS Mean Difference|2.2|||<|0.0001|TWO_SIDED|95.0|1.5|2.9|||Mixed-effects Model for Repeated Measure|||||2.9|1.5|<0.0001
91742493|NCT04474197|183378723|SUPERIORITY||LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.6|||Mixed-effects Model for Repeated Measure|||||4.6|2.4|<0.0001
91742494|NCT04474197|183378723|SUPERIORITY||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.9|4.0|||Mixed-effects Model for Repeated Measure|||||4.0|1.9|<0.0001
91742495|NCT04474197|183378723|SUPERIORITY||LS Mean Difference|2.7|||<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed-effects Model for Repeated Measure|||||3.7|1.8|<0.0001
91759517|NCT02391363|183411768|SUPERIORITY|||||||0.94||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.94
91742496|NCT00066222|183378752|OTHER|||||||||||||||||This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.|If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.|||
91742497|NCT00066222|183378755|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.|||
91513599|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.59|< 0.001
91742498|NCT00066222|183378756|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.|||
91742499|NCT00635349|183378758|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)|Mean Difference (Final Values)|1.81||||0.4258|ONE_SIDED|97.5|-6.31||||t-test, 1 sided||||||-6.31|0.4258
91742500|NCT00635349|183378759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0628|ONE_SIDED|97.5|-1.41||||t-test, 1 sided||||||-1.41|0.0628
91742501|NCT00635349|183378760|SUPERIORITY_OR_OTHER|||||||0.0131||||||Day 29: p-value was calculated by fisher exact test|Fisher Exact|||||||0.0131
91742502|NCT00635349|183378760|SUPERIORITY_OR_OTHER|||||||0.9834||||||Day 57; p-value was calculated by Chi-squared test|Chi-squared|||||||0.9834
91742503|NCT00635349|183378760|SUPERIORITY_OR_OTHER|||||||0.1131||||||Day 85; p-value was calculated by Chi-squared test|Chi-squared|||||||0.1131
91742504|NCT00295646|183378859|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|1.1||||0.59|TWO_SIDED|95.0|0.78|1.53||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter disease-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||1.53|0.78|0.59
91742505|NCT00295646|183378860|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|0.64||||0.01|TWO_SIDED|95.0|0.46|0.91||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||0.91|0.46|0.01
91742506|NCT00295646|183378861|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.11||||0.53|TWO_SIDED|95.0|0.8|1.56|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter recurrence-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.||1.56|0.80|0.53
91742507|NCT00295646|183378862|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.65||||0.01|TWO_SIDED|95.0|0.46|0.92|||Log Rank|||To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.|From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.|0.92|0.46|0.01
91742508|NCT00295646|183378863|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.8||||0.07|TWO_SIDED|95.0|0.96|3.38|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter survival time for arimidex relative to tamoxifen.|To determine the effect of anastrozole (AZ and AC) compared to tamoxifen (TZ and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||3.38|0.96|0.07
91500180|NCT00546637|182870452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1959||95.0|-0.9|0.2||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (Net) = Least squares mean|The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.||0.2|-0.9|0.1959
91500181|NCT00546637|182870453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0621||95.0|-1.0|0.0||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|||0.0|-1.0|0.0621
91500182|NCT00546637|182870455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0056||95.0|-0.8|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.8|0.0056
91742509|NCT00295646|183378864|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.6||||0.1|TWO_SIDED|95.0|0.32|1.11|||Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||1.11|0.32|0.10
91742510|NCT00418093|183378865|SUPERIORITY_OR_OTHER||Proportion|0.684|||||TWO_SIDED|95.0|0.43|0.87||Exact 95% CI for the partial response rate (13/19 = 0.684): 43.4% \~ 87.4%|Estimation of PR based on Binomial Model|We did not perform a test. Point estimate of PR and its exact 95% CI based on Binomial Model is provided. Thus there is no p-value to report.|Point estimate of PR and its exact 95% CI based on Binomial Model|||0.87|0.43|
91742511|NCT00418093|183378865|SUPERIORITY_OR_OTHER||Single Proportion|0.684|||||TWO_SIDED|95.0|0.434|0.874||We did not perform hypothesis test. We made an estimation for a single proportion (partial response) with its two-sided 95% exact Binomial confidence interval.|Fisher Exact||Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval|||0.874|0.434|
91742512|NCT03162796|183378885|SUPERIORITY||Difference in percentage|29.8|||<|0.001|TWO_SIDED|95.0|18.6|41.1|||Cochran-Mantel-Haenszel|||||41.1|18.6|< 0.001
91742513|NCT03162796|183378885|SUPERIORITY||Difference in percentage|37.1|||<|0.001|TWO_SIDED|95.0|26.1|48.2|||Cochran-Mantel-Haenszel|||||48.2|26.1|< 0.001
91500183|NCT00546637|182870455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.009||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.1|-0.7|0.0090
91500184|NCT00546637|182870456|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0012
91535609|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.17|STANDARD_ERROR_OF_MEAN|4.0||0.0006|TWO_SIDED|95.0|6.25|22.08||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||22.08|6.25|0.0006
91742514|NCT03162796|183378886|SUPERIORITY||Least Square (LS) Mean Difference|-0.2483|||<|0.001|TWO_SIDED|95.0|-0.364|-0.1325|||ANCOVA|||||-0.1325|-0.3640|< 0.001
91742515|NCT03162796|183378886|SUPERIORITY||LS Mean difference|-0.3226|||<|0.001|TWO_SIDED|95.0|-0.4385|-0.2066|||ANCOVA|||||-0.2066|-0.4385|< 0.001
91742516|NCT03162796|183378887|SUPERIORITY||Difference in percentage|21.4|||<|0.001|TWO_SIDED|95.0|12.1|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|12.1|< 0.001
91742517|NCT03162796|183378887|SUPERIORITY||Difference in percentage|27.2|||<|0.001|TWO_SIDED|95.0|17.6|36.8||Nominal|Cochran-Mantel-Haenszel|||||36.8|17.6|< 0.001
91742518|NCT03162796|183378888|SUPERIORITY||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|28.9|55.1|||Cochran-Mantel-Haenszel|||||55.1|28.9|< 0.001
91742519|NCT03162796|183378888|SUPERIORITY||Difference in percentage|60.0|||<|0.001|TWO_SIDED|95.0|48.3|71.8|||Cochran-Mantel-Haenszel|||||71.8|48.3|< 0.001
91742520|NCT03162796|183378889|SUPERIORITY||Difference in percentage|26.7|||<|0.001|TWO_SIDED|95.0|15.3|38.1||Nominal|Cochran-Mantel-Haenszel|||||38.1|15.3|< 0.001
91742521|NCT03162796|183378889|SUPERIORITY||Difference in percentage|34.8|||<|0.001|TWO_SIDED|95.0|23.5|46.0||Nominal|Cochran-Mantel-Haenszel|||||46.0|23.5|< 0.001
91742522|NCT03162796|183378890|SUPERIORITY||LS Mean difference|-0.73|||<|0.001||95.0|-0.98|-0.48||Nominal|ANCOVA|||||-0.48|-0.98|< 0.001
91742523|NCT03162796|183378890|SUPERIORITY||LS Mean difference|-0.91|||<|0.001||95.0|-1.16|-0.66||Nominal|ANCOVA|||||-0.66|-1.16|< 0.001
91742524|NCT03162796|183378891|SUPERIORITY||Difference in percentage|6.4||||0.069|TWO_SIDED|95.0|-0.3|13.1|||Cochran-Mantel-Haenszel|||||13.1|-0.3|0.069
91742525|NCT03162796|183378891|SUPERIORITY||Difference in percentage|14.8|||<|0.001|TWO_SIDED|95.0|6.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.9|< 0.001
91500185|NCT00546637|182870456|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 12||||0.0027
91500186|NCT00546637|182870457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1112||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1112
91500187|NCT00546637|182870457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0855||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.0|-0.3|0.0855
91500188|NCT00546637|182870459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.3847||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.3847
91500189|NCT00546637|182870459|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.4449||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.4449
91742526|NCT03162796|183378892|SUPERIORITY||Difference in percentage|10.2||||0.036|TWO_SIDED|95.0|1.0|19.3||Nominal|Cochran-Mantel-Haenszel|||||19.3|1.0|0.036
91742527|NCT03162796|183378892|SUPERIORITY||Difference in percentage|13.9||||0.006|TWO_SIDED|95.0|4.4|23.4||Nominal|Cochran-Mantel-Haenszel|||||23.4|4.4|0.006
91500190|NCT00546637|182870461|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33||||0.0062||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0062
91500191|NCT00546637|182870461|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.0825||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0825
91500192|NCT00546637|182870462|SUPERIORITY_OR_OTHER|||||||0.0025||95.0||||P-value for median was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0025
91500193|NCT00546637|182870463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1748||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.3|0.1748
91500194|NCT00546637|182870463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6572||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.2|-0.1|0.6572
91500195|NCT00546637|182870465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.0051||95.0|-2.9|-0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.5|-2.9|0.0051
91500196|NCT00546637|182870465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1231||95.0|-2.3|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.3|-2.3|0.1231
91742528|NCT03162796|183378893|SUPERIORITY||LS Mean difference|4.14|||<|0.001|TWO_SIDED|95.0|2.42|5.85|||ANCOVA|||||5.85|2.42|< 0.001
91742529|NCT03162796|183378893|SUPERIORITY||LS Mean difference|4.91|||<|0.001||95.0|3.19|6.63|||ANCOVA|||||6.63|3.19|< 0.001
91742530|NCT03162796|183378894|SUPERIORITY||Difference in percentage|13.0||||0.094|TWO_SIDED|95.0|-1.6|27.5||Nominal|Cochran-Mantel-Haenszel|||||27.5|-1.6|0.094
91742531|NCT03162796|183378894|SUPERIORITY||Difference in percentage|19.8||||0.013|TWO_SIDED|95.0|4.9|34.6||Nominal|Cochran-Mantel-Haenszel|||||34.6|4.9|0.013
91742532|NCT03162796|183378895|SUPERIORITY||LS Mean difference|-0.33||||0.185|TWO_SIDED|95.0|-0.83|0.16||Nominal|ANCOVA|||||0.16|-0.83|0.185
91742533|NCT03162796|183378895|SUPERIORITY||LS Mean difference|-0.74||||0.004|TWO_SIDED|95.0|-1.24|-0.24||Nominal|ANCOVA|||||-0.24|-1.24|0.004
91742534|NCT03162796|183378896|SUPERIORITY||LS Mean difference|0.83||||0.398|TWO_SIDED|95.0|-1.1|2.77||Nominal|ANCOVA|||||2.77|-1.10|0.398
91742535|NCT03162796|183378896|SUPERIORITY||LS Mean difference|1.23||||0.214|TWO_SIDED|95.0|-0.71|3.16||Nominal|ANCOVA|||||3.16|-0.71|0.214
91742536|NCT03162796|183378897|SUPERIORITY||Difference in percentage|16.6||||0.088|TWO_SIDED|95.0|-1.5|34.8||Nominal|Cochran-Mantel-Haenszel|||||34.8|-1.5|0.088
91705243|NCT03240406|183305015|SUPERIORITY||Mean Difference (Net)|-0.11||||0.019|TWO_SIDED|95.0|-0.21|-0.02||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Long Chain Saturated Fat||-0.02|-0.21|0.019
91705244|NCT03240406|183305015|SUPERIORITY||Mean Difference (Net)|0.12||||0.201|TWO_SIDED|95.0|-0.07|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for EPA||0.31|-0.07|0.201
91705245|NCT03240406|183305015|SUPERIORITY||Mean Difference (Net)|0.27||||0.039|TWO_SIDED|95.0|0.01|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for DHA||0.53|0.01|0.039
91705246|NCT03240406|183305015|SUPERIORITY||Mean Difference (Net)|-0.01||||0.619|TWO_SIDED|95.0|-0.06|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean difference of MHD Arm vs Comparison Arm|Statistical Analysis results for n3 DPA||0.03|-0.06|0.619
91705247|NCT03240406|183305016|SUPERIORITY||Mean Difference (Net)|0.18||||0.521|TWO_SIDED|95.0|-0.37|0.73||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.73|-0.37|0.521
91705248|NCT03240406|183305017|SUPERIORITY||Mean Difference (Net)|145.0||||0.101|TWO_SIDED|95.0|-27.7|317.6||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||317.6|-27.7|0.101
91705249|NCT03240406|183305018|SUPERIORITY||Mean Difference (Net)|-24.63||||0.645|TWO_SIDED|95.0|-129.16|79.89||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||79.89|-129.16|0.645
91705250|NCT03240406|183305019|SUPERIORITY||Mean Difference (Net)|3.26||||0.245|TWO_SIDED|95.0|-2.23|8.75||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||8.75|-2.23|0.245
91705251|NCT03240406|183305020|SUPERIORITY||Mean Difference (Net)|0.21||||0.032|TWO_SIDED|95.0|0.02|0.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.4|0.02|0.032
91705252|NCT03240406|183305021|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.26|0.08|<0.001
91705253|NCT03240406|183305022|SUPERIORITY||Mean Difference (Net)|-1.36||||0.635|TWO_SIDED|95.0|-6.95|4.24||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.24|-6.95|0.635
91705254|NCT03240406|183305023|SUPERIORITY||Mean Difference (Net)|-3.52||||0.019|TWO_SIDED|95.0|-6.44|0.59||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.59|-6.44|0.019
91705255|NCT03240406|183305024|SUPERIORITY||Mean Difference (Net)|-3.13||||0.639|TWO_SIDED|95.0|-16.18|9.92||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||9.92|-16.18|0.639
91705256|NCT03240406|183305025|SUPERIORITY||Mean Difference (Net)|41.71|||<|0.001|TWO_SIDED|95.0|21.47|61.96||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||61.96|21.47|<0.001
91705257|NCT03240406|183305026|SUPERIORITY||Mean Difference (Net)|-15.37||||0.115|TWO_SIDED|95.0|-34.44|3.69||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||3.69|-34.44|0.115
91705258|NCT03240406|183305027|SUPERIORITY||Mean Difference (Net)|0.06||||0.847|TWO_SIDED|95.0|-0.53|0.64||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.64|-0.53|0.847
91705259|NCT03240406|183305028|SUPERIORITY||Mean Difference (Net)|118.57||||0.191|TWO_SIDED|95.0|-58.62|295.76||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||295.76|-58.62|0.191
91742537|NCT03162796|183378897|SUPERIORITY||Difference in percentage|13.4||||0.212|TWO_SIDED|95.0|-6.9|33.7||Nominal|Cochran-Mantel-Haenszel|||||33.7|-6.9|0.212
91742538|NCT03162796|183378898|SUPERIORITY||LS Mean difference|-1.82||||0.121|TWO_SIDED|95.0|-4.12|0.49||Nominal|ANCOVA|||||0.49|-4.12|0.121
91742539|NCT03162796|183378898|SUPERIORITY||LS Mean difference|-1.53||||0.225|TWO_SIDED|95.0|-4.0|0.95||Nominal|ANCOVA|||||0.95|-4.00|0.225
91742540|NCT00289289|183378996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.8||0.629|ONE_SIDED|95.0||0.5||P-value is from a paired t-test since each subject had the intervention pacing features turned ON and OFF in this crossover study|t-test, 1 sided|One-sided paired t-test with 221 degrees of freedom|A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF.|Null Hypothesis: rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods when intervention pacing features ON is greater to or equal to the rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods where intervention pacing features were programmed OFF Alternative Hypothesis: rate of symptomatic AT/AF during periods of ON programming is less than the rate of symptomatic AT/AF during OFF programming||0.5||0.629
91742541|NCT00289289|183378997|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.165|||||||Wilcoxon (Mann-Whitney)|P-value is from Koch's adaptation to the Wilcoxon Rank-Sum test comparing the within subject ON minus OFF differences to 0|A negative change means an improvement in AF symptom frequency with intervention pacing therapy programmed ON. Total possible improvement while intervention features are programmed ON is -64. Total possible worsening during ON programming is 64.|"The null hypothesis is that the symptom frequency score does not differ between while intervention pacing features were programmed ON versus OFF.~This secondary objective was not powered."||||0.165
91742542|NCT00289289|183378998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.603|TWO_SIDED|95.0|0.39|1.73||P-value is based on a repeated measures Cox proportional hazards model to the rate of AF cardioversion attempts between periods of ON and OFF programming|Regression, Cox||Hazard Ratio compares rate of first attempted cardioversion for AF while the intervention pacing features were programmed ON versus OFF.|"Null Hypothesis: AF Cardioversion attempt rate is the same during periods of ON and OFF programming~Alternative Hypothesis: AF Cardioversion attempt rate is different during periods of ON and OFF programming"||1.73|0.39|0.603
91742543|NCT00289289|183378999|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.394||95.0||||Within each randomized subject, the ON minus OFF difference in AT/AF burden was computed. The Wilcoxon Signed-Rank test was used to determine if the ON minus OFF difference in AT/AF burden was different from zero.|Wilcoxon (Mann-Whitney)||A negative median difference represents an improvement (lessening) of AT/AF burden during periods of ON versus OFF programming. A positive median difference represents an increase in AT/AF burden during ON compared to OFF programming.|Null Hypothesis: There is no difference in AT/AF burden during periods on ON and OFF programming Alternative Hypothesis: AT/AF burden is lower during periods of ON programming compared to periods of OFF programming||||0.394
91742544|NCT06875284|183379029|SUPERIORITY||Mean Difference (Net)|-9.01|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-11.06|-6.96|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-6.96|-11.06|<0.0001
91742545|NCT06875284|183379029|SUPERIORITY||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|1.05||0.041|TWO_SIDED|95.0|-4.22|-0.09|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-0.09|-4.22|0.041
91742546|NCT06875284|183379029|SUPERIORITY||Mean Difference (Net)|-8.51|STANDARD_ERROR_OF_MEAN|1.15|<|0.0001|TWO_SIDED|95.0|-10.76|-6.25|||Mixed Models Analysis||Covariates included cohort and history of peer victimization.||The SCC plus eCHECKUP TO GO arm was the reference group.|-6.25|-10.76|<0.0001
91742547|NCT06875284|183379030|SUPERIORITY||Mean Difference (Net)|-1.18|STANDARD_ERROR_OF_MEAN|0.56||0.035|TWO_SIDED|95.0|-2.27|-0.08|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-0.08|-2.27|0.035
91742548|NCT06875284|183379030|SUPERIORITY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.56||0.54|TWO_SIDED|95.0|-1.44|0.76|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||0.76|-1.44|0.54
91742549|NCT06875284|183379030|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.023|TWO_SIDED|95.0|-2.6|-0.19|||Mixed Models Analysis|||||-0.19|-2.60|0.023
91742550|NCT06875284|183379031|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-3.98|-1.34|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-1.34|-3.98|<0.0001
91742551|NCT06875284|183379031|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_ERROR_OF_MEAN|0.69||0.012|TWO_SIDED|95.0|-3.09|-0.39|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-0.39|-3.09|0.012
91742552|NCT06875284|183379031|SUPERIORITY||Median Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|0.73||0.0008|TWO_SIDED|95.0|-3.88|-1.03|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-1.03|-3.88|0.0008
91742553|NCT06875284|183379032|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.26||0.058|TWO_SIDED|95.0|-0.02|1.02|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||1.02|-0.02|0.058
91742554|NCT06875284|183379032|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.046|TWO_SIDED|95.0|-1.07|-0.01|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-0.01|-1.07|0.046
91500197|NCT00546637|182870466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3579||95.0|-1.0|0.4||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.4|-1.0|0.3579
91742555|NCT06875284|183379032|SUPERIORITY||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.29||0.097|TWO_SIDED|95.0|-1.06|0.09|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||0.09|-1.06|0.097
91742556|NCT06875284|183379033|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.64|TWO_SIDED|95.0|-0.16|0.26|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||0.26|-0.16|0.64
91742557|NCT06875284|183379033|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.11||0.25|TWO_SIDED|95.0|-0.09|0.33|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||0.33|-0.09|0.25
91742558|NCT06875284|183379033|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.033|TWO_SIDED|95.0|-0.47|-0.02|||Mixed Models Analysis||The SCC plus eCHECKUP TO GO arm was the reference group.|||-0.02|-0.47|0.033
91742559|NCT06631274|183379036|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|-0.056||||0.646|TWO_SIDED|95.0|-0.296|0.184|||ANOVA|one-way repeated measures ANOVA was conducted for personal adjustment|Hedges' g=-0.14. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|The outcome measure is personal adjustment||0.184|-0.296|0.646
91742560|NCT06631274|183379036|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|0.188||||0.196|TWO_SIDED|95.0|-0.096|0.473|||ANOVA|one-way repeated measures ANOVA was conducted for internalizing problems|Hedges' g=0.40. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|The outcome measure is internalizing problems||0.473|-0.096|0.196
91742561|NCT06631274|183379037|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|0.326|||<|0.01|TWO_SIDED|95.0|0.112|0.539|||ANOVA|one-way repeated ANOVA was conducted|Hedges' g=0.92. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|||0.539|0.112|<0.01
91500198|NCT00546637|182870466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9274||95.0|-0.8|0.7||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.8|0.9274
91742562|NCT06631274|183379038|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|0.681||||0.11|TWO_SIDED|95.0|-0.187|1.549|||ANOVA|one-way repeated measures ANOVA was conducted.|Hedges' g=0.51. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|||1.549|-0.187|0.11
91742563|NCT06631274|183379039|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|0.078||||0.599|TWO_SIDED|95.0|-0.212|0.367|||ANOVA|one-way repeated measures ANOVA was conducted for avoidance coping|Hedges' g=0.16. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|The outcome measure is avoidance coping||0.367|-0.212|0.599
91742564|NCT06631274|183379039|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|0.316||||0.044|TWO_SIDED|95.0|0.152|0.617|||ANOVA|one-way repeated measures ANOVA was conducted for approach coping|Hedges' g=0.63. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|The outcome measure is approach coping||0.617|0.152|0.044
91500199|NCT00546637|182870467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0223||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.7|0.0223
91500200|NCT00546637|182870467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1744||95.0|-0.6|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.6|0.1744
91705260|NCT03240406|183305029|SUPERIORITY||Mean Difference (Net)|955.19||||0.019|TWO_SIDED|95.0|164.63|1745.74||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1745.74|164.63|0.019
91705261|NCT03240406|183305030|SUPERIORITY||Mean Difference (Net)|-15.74||||0.493|TWO_SIDED|95.0|-60.66|29.19||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||29.19|-60.66|0.493
91705262|NCT03240406|183305031|SUPERIORITY||Mean Difference (Net)|14.83||||0.18|TWO_SIDED|95.0|-6.78|36.45||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||36.45|-6.78|0.18
91705263|NCT03240406|183305032|SUPERIORITY||Mean Difference (Net)|436.14||||0.379|TWO_SIDED|95.0|-534.05|1406.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1406.33|-534.05|0.379
91705264|NCT03240406|183305033|SUPERIORITY||Mean Difference (Net)|784.06||||0.083|TWO_SIDED|95.0|-99.73|1667.85||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1667.85|-99.73|0.083
91705265|NCT03240406|183305034|SUPERIORITY||Mean Difference (Net)|1.33||||0.011|TWO_SIDED|95.0|0.32|2.35||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||2.35|0.32|0.011
91705266|NCT03240406|183305035|SUPERIORITY||Mean Difference (Net)|0.07||||0.541|TWO_SIDED|95.0|-0.16|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.31|-0.16|0.541
91705267|NCT03240406|183305036|SUPERIORITY||Mean Difference (Net)|0.01||||0.273|TWO_SIDED|95.0|-0.01|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.03|-0.01|0.273
91705268|NCT03240406|183305037|SUPERIORITY||Mean Difference (Net)|0.03||||0.116|TWO_SIDED|95.0|-0.01|0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.06|-0.01|0.116
91705269|NCT03240406|183305038|SUPERIORITY||Mean Difference (Net)|0.0||||0.213|TWO_SIDED|95.0|0.0|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.01|0|0.213
91705270|NCT03240406|183305039|SUPERIORITY||Mean Difference (Net)|0.05||||0.036|TWO_SIDED|95.0|0.0|0.09||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.09|0|0.036
91705271|NCT03240406|183305040|SUPERIORITY||Mean Difference (Net)|0.17||||0.223|TWO_SIDED|95.0|-0.1|0.43||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.43|-0.1|0.223
91705272|NCT03240406|183305041|SUPERIORITY||Mean Difference (Net)|-0.17||||0.119|TWO_SIDED|95.0|-0.38|0.04||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.04|-0.38|0.119
91705273|NCT03240406|183305042|SUPERIORITY||Mean Difference (Net)|-0.04||||0.841|TWO_SIDED|95.0|-0.41|0.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.33|-0.41|0.841
91705274|NCT03240406|183305043|SUPERIORITY||Mean Difference (Net)|0.25||||0.088|TWO_SIDED|95.0|-0.04|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.53|-0.04|0.088
91705275|NCT03240406|183305044|SUPERIORITY||Mean Difference (Net)|-0.01||||0.893|TWO_SIDED|95.0|-0.13|0.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.11|-0.13|0.893
91500201|NCT00546637|182870468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7564||95.0|-0.4|0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.5|-0.4|0.7564
91531238|NCT02916862|182939114|SUPERIORITY|Power calculations were done for Aim 1, so the main analysis was done only between SCF and placebo. Significance was set at a p value \<0.05.|Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.92||0.377|TWO_SIDED|95.0|-2.12|5.53||We adjusted the models for baseline age, sex, Tanner stage (puberty status), percent change in weight, and percent change in height.|ANCOVA|We adjusted the models for baseline age, sex, Tanner stage (puberty status), percent change in weight, and percent change in height.||The main analyses were performed on an intention-to-treat basis. For the primary analysis, percent change from baseline in whole-body BMC after one year of supplement (SCF) vs placebo (AIM 1), we used analysis of covariance, adjusted for baseline age, sex, Tanner stage (puberty status), percent change in weight, and percent change in height. Effects were considered significant at the alpha level of 0.05.||5.53|-2.12|0.377
91531239|NCT02916862|182939114|SUPERIORITY|Significance was set at a p value \<0.05.|Mean Difference (Net)|1.95|STANDARD_DEVIATION|1.8||0.245|TWO_SIDED|95.0|-1.366|5.266|||ANCOVA|||The main analyses were performed on an intention-to-treat basis. For the secondary analysis, percent change from baseline in whole-body BMC after one year of supplement (SCF+calcium) vs placebo+calcium (AIM 2), we used analysis of covariance, adjusted for baseline age, sex, Tanner stage (puberty status), percent change in weight, and percent change in height. Effects were considered significant at the alpha level of 0.05.||5.266|-1.366|0.245
91742565|NCT06631274|183379040|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|1.024|||<|0.01|TWO_SIDED|95.0|0.284|1.764|||ANOVA|one-way repeated measures ANOVA was conducted|Hedges' g=0.85. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|||1.764|0.284|<.01
91742566|NCT06631274|183379041|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|-0.589||||0.0498|TWO_SIDED|95.0|-1.178|-0.0005|||ANOVA|one-way repeated measures ANOVA was conducted|Hedges' g=-0.61. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|||-0.0005|-1.178|0.0498
91531240|NCT02916862|182939115|SUPERIORITY||Mean Difference (Net)|1.655||||0.05|TWO_SIDED|95.0|-0.765|8.143|||ANCOVA|||The main analyses were performed on an intention-to-treat basis. For the secondary analysis, percent change from baseline in lumbar BMC after one year of supplement (SCF) vs placebo, we used analysis of covariance, adjusted for baseline age, sex, Tanner stage (puberty status), percent change in weight, and percent change in height. Effects were considered significant at the alpha level of 0.05.||8.143|-0.765|0.05
91531241|NCT02916862|182939115|SUPERIORITY||Mean Difference (Net)|1.035|STANDARD_ERROR_OF_MEAN|2.535||0.05|TWO_SIDED|95.0|-7.68|2.435|||ANCOVA|||||2.435|-7.680|0.05
91742567|NCT06631274|183379042|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|0.261||||0.182|TWO_SIDED|95.0|-0.127|0.65|||ANOVA|one-way repeated measures ANOVA was conducted|Hedges' g=0.41. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|||0.650|-0.127|0.182
91742568|NCT06631274|183379043|EQUIVALENCE|A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported.|Mean Difference (Final Values)|-0.03||||0.927|TWO_SIDED|95.0|-0.612|0.551|||ANOVA|one-way repeated measures ANOVA was conducted|Hedges' g=-0.04. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group.|||0.551|-0.612|0.927
91742569|NCT02842086|183379049|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.468|||||TWO_SIDED|95.003|0.191|1.149||||||Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.149|0.191|
91742570|NCT02842086|183379050|SUPERIORITY||Difference in least squares mean (LSM)|1.142|||<|0.0001|TWO_SIDED|95.0|0.628|1.655|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.||1.655|0.628|<0.0001
91742571|NCT02842086|183379051|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.913|2.22|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.220|0.913|<0.0001
91742572|NCT02842086|183379052|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
91500202|NCT00546637|182870468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.401||95.0|-0.3|0.7||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.3|0.4010
91742573|NCT02842086|183379053|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
91742574|NCT02842086|183379054|SUPERIORITY|||||||0.0048||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.0048
91742575|NCT02842086|183379055|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
91742576|NCT02842086|183379056|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.536|||||TWO_SIDED|95.003|0.227|1.264||||||Noninferiority was assessed using a 95.003% CI constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.264|0.227|
91742577|NCT02842086|183379057|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.896|2.237|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.237|0.896|<0.0001
91742578|NCT02842086|183379058|SUPERIORITY||Difference in LSM|2.253|||<|0.0001|TWO_SIDED|95.0|1.437|3.069|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||3.069|1.437|<0.0001
91742579|NCT02842086|183379059|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
91742580|NCT02842086|183379060|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
91742581|NCT02842086|183379061|SUPERIORITY|||||||0.2163||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.2163
91742582|NCT02842086|183379062|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
91742583|NCT05696444|183379065|SUPERIORITY|Test was calculated using an exact test against a null value of 0.85.|||||<|0.0001|||||||Exact test|||||||<0.0001
91742584|NCT05696444|183379066|SUPERIORITY|Test was calculated using an exact test against a null value of 0.2||||||0.0006||||||Holm adjusted at alpha = 0.025|Exact test|||||||0.0006
91742585|NCT05696444|183379066|SUPERIORITY|||||||0.0025||||||Holm adjusted at alpha = 0.025|Exact test|||Test was calculated using an exact test against a null value of 0.45||||0.0025
91742586|NCT05696444|183379066|SUPERIORITY|||||||0.0001||||||Holm adjusted at alpha = 0.025|Exact test|||Test was calculated using an exact test against a null value of 0.2||||0.0001
91742587|NCT03759639|183379080|SUPERIORITY||Hodges-Lehmann Estimator|1.0||||0.029|TWO_SIDED|90.0|0.25|1.75|||1-sided Wilcoxon signed-rank test|||||1.75|0.25|0.029
91742588|NCT03759639|183379082|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.318|TWO_SIDED|90.0|-0.25|0.5|||1-sided Wilcoxon signed-rank test|||||0.50|-0.25|0.318
91742589|NCT03759639|183379085|SUPERIORITY||Hodges-Lehmann Estimator|0.0854||||0.084|TWO_SIDED|90.0|-0.0123|0.1777|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1777|-0.0123|0.084
91742590|NCT03759639|183379085|SUPERIORITY||Hodges-Lehmann Estimator|-0.0399||||0.315|TWO_SIDED|90.0|-0.1269|0.1031|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.1031|-0.1269|0.315
91742591|NCT03759639|183379086|SUPERIORITY||Hodges-Lehmann Estimator|-1.25||||0.001|TWO_SIDED|90.0|-1.75|-0.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.50|-1.75|0.001
91742592|NCT03759639|183379086|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.002|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.002
91742593|NCT03759639|183379088|SUPERIORITY||Hodges-Lehmann Estimator|0.0||||0.121|TWO_SIDED|90.0|-0.021|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.021|0.121
91742594|NCT03759639|183379088|SUPERIORITY||Hodges-Lehmann Estimator|0.021||||0.056|TWO_SIDED|90.0|0.0|0.042|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.042|0.000|0.056
91742595|NCT03759639|183379089|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||<0.001
91742596|NCT03759639|183379089|SUPERIORITY||Mean Difference (Net)|4.5||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.006
91742597|NCT03759639|183379090|SUPERIORITY||Mean Difference (Net)|3.4||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.005
91742598|NCT03759639|183379090|SUPERIORITY||Mean Difference (Net)|4.4||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.038
91742599|NCT03759639|183379091|SUPERIORITY||Mean Difference (Net)|3.3||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment with IB1001||||0.003
91742600|NCT03759639|183379091|SUPERIORITY||Mean Difference (Net)|4.4||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.034
91742601|NCT00161616|183379113|SUPERIORITY_OR_OTHER|||||||0.0541|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 13.||||0.0541
91742602|NCT00161616|183379113|SUPERIORITY_OR_OTHER|||||||0.7983|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 20.||||0.7983
91742603|NCT00161616|183379114|SUPERIORITY_OR_OTHER|||||||0.8961|||||||Fisher Exact|||||||0.8961
91742604|NCT00861757|183379116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|||||-0.6|-3.0|0.003
91742605|NCT00861757|183379116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.9|-0.6|||ANCOVA|||||-0.6|-2.9|0.004
91742606|NCT00861757|183379116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.7|-1.3|||ANCOVA|||||-1.3|-3.7|<0.001
91500203|NCT00546637|182870469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1472||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1472
91500204|NCT00546637|182870469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5839||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.2|0.5839
91500205|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6621||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q1||0.2|-0.1|0.6621
91742607|NCT00861757|183379117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.6||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.6|-2.2|<0.001
91742608|NCT00861757|183379117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.005|TWO_SIDED|95.0|-1.9|-0.3||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.3|-1.9|0.005
91742609|NCT00861757|183379117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.1||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-1.1|-2.7|<0.001
91742610|NCT00861757|183379117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.072|TWO_SIDED|95.0|-1.0|0.0||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||0.0|-1.0|0.072
91742611|NCT00861757|183379117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.021|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.021
91742612|NCT00861757|183379117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.023|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.023
91742613|NCT00861757|183379118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.031
91742614|NCT00861757|183379118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.013
91531242|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.031||0.79|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||The null hypothesis was the that proportions of patients with at least one OAC filled at one year were the same between the two groups.||1.07|0.95|0.79
91531243|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.039||0.307|TWO_SIDED|95.0|0.96|1.12|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 183 days were the same between the two groups.||1.12|0.96|0.307
91742615|NCT00861757|183379118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||||-0.4|-0.9|<0.001
91742616|NCT00861757|183379119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.201
91742617|NCT00861757|183379119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.393|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.393
91742618|NCT00861757|183379119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.4|-0.2|||ANCOVA|||||-0.2|-1.4|0.007
91742619|NCT00861757|183379120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.331|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||||0.5|-1.6|0.331
91742620|NCT00861757|183379120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.14|TWO_SIDED|95.0|-1.8|0.3|||ANCOVA|||||0.3|-1.8|0.140
91742621|NCT00861757|183379120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||||1.0|-1.1|0.940
91742622|NCT00861757|183379121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
91742623|NCT00861757|183379121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
91742624|NCT00861757|183379121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
91500206|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.5|-0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q2||-0.2|-0.5|<.0001
91500207|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3242||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q3||0.2|-0.1|0.3242
91742625|NCT00861757|183379122|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.034
91742626|NCT00861757|183379122|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.002
91742627|NCT00861757|183379122|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.001
91742628|NCT00861757|183379123|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.412
91742629|NCT00861757|183379123|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.083
91742630|NCT00861757|183379123|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.456
91742631|NCT00861757|183379124|SUPERIORITY_OR_OTHER|||||||0.688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.688
91742632|NCT00861757|183379124|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.510
91742633|NCT00861757|183379124|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.212
91742634|NCT00861757|183379125|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.005
91742635|NCT00861757|183379125|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.274
91742636|NCT00861757|183379125|SUPERIORITY_OR_OTHER|||||||0.538||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.538
91742637|NCT00861757|183379125|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.008
91742638|NCT00861757|183379125|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.216
91742639|NCT00861757|183379125|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.524
91742640|NCT00861757|183379126|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.007
91742641|NCT00861757|183379126|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.723
91742642|NCT00861757|183379126|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.273
91742643|NCT00861757|183379126|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.005
91742644|NCT00861757|183379126|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.054
91742645|NCT00861757|183379126|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.278
91742646|NCT00861757|183379127|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon rank-sum test|||||||0.330
91742647|NCT00861757|183379127|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||Wilcoxon rank-sum test|||||||0.838
91742648|NCT00861757|183379127|SUPERIORITY_OR_OTHER|||||||0.409||95.0|||||Wilcoxon rank-sum test|||||||0.409
91742649|NCT01701362|183379176|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1823||95.0|-0.54|0.1|||Mixed Model Repeated Measures Analysis|Mixed Model Repeated Measures = MMRM|MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method|||0.10|-0.54|0.1823
91742650|NCT01701362|183379177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||||||The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.|Cochran-Mantel-Haenszel|||||||0.0012
91742651|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.0119||95.0|-0.62|-0.08|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 1||-0.08|-0.62|0.0119
91742652|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0135||95.0|-0.62|-0.07|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 2||-0.07|-0.62|0.0135
91742653|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0028||95.0|-0.69|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 3||-0.14|-0.69|0.0028
91742654|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0016||95.0|-0.72|-0.17|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 4||-0.17|-0.72|0.0016
91742655|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 5||-0.20|-0.75|0.0007
91742656|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0006||95.0|-0.76|-0.21|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 6||-0.21|-0.76|0.0006
91742657|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 7||-0.20|-0.75|0.0008
91742658|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003||95.0|-0.79|-0.24|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 8||-0.24|-0.79|0.0003
91742659|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.26|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 9||-0.26|-0.82|0.0001
91500208|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1604||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q4||0.0|-0.3|0.1604
91742660|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.77|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 10||-0.22|-0.77|0.0005
91742661|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.76|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 11||-0.20|-0.76|0.0007
91742662|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.27|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 12||-0.27|-0.82|0.0001
91742663|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.84|-0.28|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 13||-0.28|-0.84|<0.0001
91742664|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.78|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 14||-0.22|-0.78|0.0005
91742665|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.15||0.0031||95.0|-0.71|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 15||-0.14|-0.71|0.0031
91742666|NCT01701362|183379178|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.71|-0.23|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Overall||-0.23|-0.71|0.0001
91742667|NCT01701362|183379179|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005||95.0|-0.77|-0.14|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.14|-0.77|0.0050
91742668|NCT01701362|183379180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0168||95.0|-0.7|-0.07|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.07|-0.70|0.0168
91742669|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.6841||95.0|-0.09|0.06|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for mobility||0.06|-0.09|0.6841
91742670|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6564||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for self-care||0.04|-0.07|0.6564
91742671|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.043||0.859||95.0|-0.08|0.09|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for usual activities||0.09|-0.08|0.8590
91742672|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.1628||95.0|-0.14|0.02|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for pain/discomfort||0.02|-0.14|0.1628
91742673|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.4654||95.0|-0.05|0.1|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for anxiety/depression||0.10|-0.05|0.4654
91531244|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.052||0.375|TWO_SIDED|95.0|0.95|1.16|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 90 days were the same between the two groups.||1.16|0.95|0.375
91742674|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.017||0.5||95.0|-0.02|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 1997 Index score||0.04|-0.02|0.5000
91500209|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4102||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q5||0.1|-0.2|0.4102
91500210|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3079||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q6||0.2|-0.1|0.3079
91500211|NCT00546637|182870470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4066|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q7||0.2|-0.1|0.4066
91500212|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1595||95.0|0.0|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q1||0.3|-0.0|0.1595
91500213|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0614||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q2||0.0|-0.3|0.0614
91500214|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2032||95.0|-0.1|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q3||0.3|-0.1|0.2032
91531245|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.076||0.265|TWO_SIDED|95.0|0.94|1.26|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 42 days were the same between the two groups.||1.26|0.94|0.265
91531246|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.044||0.237|TWO_SIDED|95.0|0.97|1.15|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among females were the same between the two groups.||1.15|0.97|0.237
91500215|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0631||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q4||0.0|-0.3|0.0631
91742675|NCT01701362|183379181|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.026||0.5493||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 2001 Index Score||0.04|-0.07|0.5493
91742676|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.8||0.0545||95.0|-0.07|7.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Disturbance Score||7.00|-0.07|0.0545
91742677|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3913||95.0|-6.47|2.54|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Adequancy Score||2.54|-6.47|0.3913
91500216|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9706||95.0|-0.2|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q5||0.2|-0.2|0.9706
91500217|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8058||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q6||0.2|-0.1|0.8058
91500218|NCT00546637|182870471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3302|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q7||0.2|-0.1|0.3302
91500219|NCT00546637|182870472|SUPERIORITY_OR_OTHER|||||||0.1136||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.1136
91500220|NCT00546637|182870473|SUPERIORITY_OR_OTHER|||||||0.5775||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.5775
91500221|NCT00546637|182870474|SUPERIORITY_OR_OTHER|||||||0.7433||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.7433
91531247|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.042||0.487|TWO_SIDED|95.0|0.89|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among males were the same between the two groups.||1.05|0.89|0.487
91531248|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.125||0.952|TWO_SIDED|95.0|0.78|1.27|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \<= 64 yrs were the same between the two groups.||1.27|0.78|0.952
91531249|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.057||0.696|TWO_SIDED|95.0|0.91|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among age 65 - 74 yrs were the same between the two groups.||1.14|0.91|0.696
91500222|NCT00546637|182870475|SUPERIORITY_OR_OTHER|||||||0.9402||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.9402
91500223|NCT00546637|182870476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.9||0.004||95.0|-4.5|-0.9||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.9|-4.5|0.0040
91742678|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.04||0.6059||95.0|-5.06|2.96|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Snoring Score||2.96|-5.06|0.6059
91531250|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.047||0.584|TWO_SIDED|95.0|0.94|1.13|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age 75 - 84 yrs were the same between groups.||1.13|0.94|0.584
91742679|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.7317||95.0|-2.76|3.93|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Awaken Short of Breath Score||3.93|-2.76|0.7317
91742680|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2663||95.0|-0.45|0.12|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Quantity of Sleep Score (hours)||0.12|-0.45|0.2663
91742681|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1562||95.0|-5.08|0.82|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Somnolence Score||0.82|-5.08|0.1562
91742682|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.45||0.249||95.0|-1.18|4.53|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Problem Index (9) Score||4.53|-1.18|0.2490
91742683|NCT01701362|183379183|SUPERIORITY_OR_OTHER_LEGACY||leaet squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0609||95.0|-0.15|0.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Optimal Sleep Score||0.00|-0.15|0.0609
91742684|NCT01701362|183379184|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7165||||||p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.|Cochran-Mantel-Haenszel|||||||0.7165
91742685|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2||||0.0028||95.0|1.5|6.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.86|1.50|0.0028
91742686|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.036||95.0|1.03|2.68|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||2.68|1.03|0.0360
91742687|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0235||95.0|1.07|2.45|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||2.45|1.07|0.0235
91742688|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.0619||95.0|0.98|2.24|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.24|0.98|0.0619
91742689|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.0677||95.0|0.97|2.2|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||2.20|0.97|0.0677
91742690|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0707||95.0|0.97|2.16|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.16|0.97|0.0707
91742691|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.1313||95.0|0.91|2.06|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.06|0.91|0.1313
91742692|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.3072||95.0|0.82|1.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||1.86|0.82|0.3072
91742693|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.3947||95.0|0.79|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||1.80|0.79|0.3947
91742694|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.1462||95.0|0.9|2.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.05|0.90|0.1462
91500224|NCT00546637|182870476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.0068||95.0|-4.8|-0.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.8|-4.8|0.0068
91500225|NCT00546637|182870477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.9||0.0412||95.0|0.1|3.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||3.6|0.1|0.0412
91531251|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.069||0.911|TWO_SIDED|95.0|0.87|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \>= 85 yrs were the same between the two groups.||1.14|0.87|0.911
91742695|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6854||95.0|0.72|1.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||1.64|0.72|0.6854
91742696|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.5025||95.0|0.76|1.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||1.74|0.76|0.5025
91742697|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.4908||95.0|0.76|1.76|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||1.76|0.76|0.4908
91742698|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.4245||95.0|0.78|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||1.80|0.78|0.4245
91742699|NCT01701362|183379185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8464||95.0|0.61|1.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||1.49|0.61|0.8464
91742700|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.1633||95.0|0.74|6.0|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.00|0.74|0.1633
91742701|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0652||95.0|0.96|3.85|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||3.85|0.96|0.0652
91742702|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.0039||95.0|1.29|3.77|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||3.77|1.29|0.0039
91742703|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0382||95.0|1.03|2.83|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.83|1.03|0.0382
91742704|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||0.0137||95.0|1.14|3.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||3.05|1.14|0.0137
91742705|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0693||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.49|0.97|0.0693
91742706|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.0349||95.0|1.04|2.73|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.73|1.04|0.0349
91742707|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1227||95.0|0.91|2.29|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||2.29|0.91|0.1227
91742708|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.0364||95.0|1.03|2.63|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||2.63|1.03|0.0364
91742709|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0667||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.49|0.97|0.0667
91500226|NCT00546637|182870477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1373||95.0|-0.5|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||3.4|-0.5|0.1373
91500227|NCT00546637|182870478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.0941||95.0|-0.3|3.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.8|-0.3|0.0941
91500228|NCT00546637|182870478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.1||0.2273||95.0|-0.8|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||3.4|-0.8|0.2273
91500229|NCT00546637|182870479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0507||95.0|0.0|4.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.3|-0.0|0.0507
91500230|NCT00546637|182870479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.2||0.1136||95.0|-0.4|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||4.1|-0.4|0.1136
91500231|NCT00546637|182870480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.1||0.0845||95.0|-0.3|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.1|-0.3|0.0845
91500232|NCT00546637|182870480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.2||0.0662||95.0|-0.2|4.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||4.6|-0.2|0.0662
91500233|NCT00546637|182870481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.1085||95.0|-0.3|3.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.2|-0.3|0.1085
91500234|NCT00546637|182870481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7685||95.0|-1.6|2.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||2.1|-1.6|0.7685
91531252|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.057||0.746|TWO_SIDED|95.0|0.88|1.1|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among those with a CHADS-VASC of 2-3 were the same between the two groups.||1.10|0.88|0.746
91531253|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.048||0.109|TWO_SIDED|95.0|0.98|1.19|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score of 4-5 were the same between the two groups.||1.19|0.98|0.109
91500235|NCT00546637|182870482|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.0||||0.0005||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0005
91500236|NCT00546637|182870482|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.0|||<|0.0001||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 8||||<.0001
91531254|NCT03259373|182939126|SUPERIORITY||Odds Ratio (OR)|0.94|STANDARD_ERROR_OF_MEAN|0.057||0.244|TWO_SIDED|95.0|0.84|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score \>=6 were the same between the two groups.||1.05|0.84|0.244
91742710|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.0176||95.0|1.1|2.84|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||2.84|1.10|0.0176
91742711|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.03||||0.003||95.0|1.27|3.23|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||3.23|1.27|0.0030
91500237|NCT00546637|182870482|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.0||||0.0003||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0003
91500238|NCT00546637|182870483|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.2251||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|||||0.2251
91500239|NCT00587483|182870486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.37||An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.|Regression, Logistic|||The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.||1.37|0.48|0.427
91500240|NCT00587483|182870486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.117|TWO_SIDED|95.0|0.39|1.11|||Regression, Logistic|||||1.11|0.39|0.117
91500241|NCT00587483|182870486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.433|TWO_SIDED|95.0|0.47|1.37|||Regression, Logistic|||||1.37|0.47|0.433
91500242|NCT00587483|182870487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.215|TWO_SIDED|95.0|0.45|1.19|||Regression, Logistic|||||1.19|0.45|0.215
91531255|NCT03259373|182939127|SUPERIORITY||Hazard Ratio (HR)|0.92|STANDARD_ERROR_OF_MEAN|0.079||0.3|TWO_SIDED|95.0|0.79|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.79|0.300
91742712|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0256||95.0|1.07|2.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||2.74|1.07|0.0256
91742713|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.0314||95.0|1.05|2.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||2.64|1.05|0.0314
91742714|NCT01701362|183379186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.1889||95.0|0.85|2.21|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||2.21|0.85|0.1889
91742715|NCT00443872|183379194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of mean group scores at baseline and 12 weeks||||<0.01
91742716|NCT00443872|183379195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91742717|NCT00443872|183379196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided||Comparison of baseline vs. 3 month circumference of the Left and Right lower leg/ankle (change identical for both legs).|Change in pedal edema as measured by change in lower leg/ankle circumference in the left and right legs||||<0.01
91742718|NCT00443872|183379197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
91742719|NCT00443872|183379198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis is for the Activities of Daily Living (ADL) section of the scale||||<0.01
91742720|NCT00443872|183379198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|||||This analysis is for the motor section of the UPDRS|Wilcoxon (Mann-Whitney)|||||||<0.05
91742721|NCT00443872|183379199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91742722|NCT00443872|183379200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91742723|NCT00443872|183379201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91742724|NCT00443872|183379202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91742725|NCT00700622|183379205|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|-0.31|0.17|||ANCOVA|||||0.17|-0.31|
91742726|NCT00282087|183379206|SUPERIORITY_OR_OTHER||Two year PFS|78.0||||0.15|TWO_SIDED|95.0|67.0|91.0|||Bayesian Posterior Probability|||The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.||91|67|0.15
91742727|NCT00282087|183379208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00269|||||TWO_SIDED||||||Cox Proportional Hazards|||Age correlation with progression-free survival for patients on study treatment.||||
91742728|NCT00282087|183379209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02|||||TWO_SIDED||||||Cox Proportional Hazards|||Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.||||
91742729|NCT00282087|183379210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.101|||||TWO_SIDED||||||Cox Proportional Hazards|||Uterine serosal involvement correlation with progression-free survival for patients on study treatment.||||
91742730|NCT00282087|183379211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00676|||||TWO_SIDED||||||Cox Proportional Hazards|||Mitotic rate correlation with progression-free survival for patients on study treatment.||||
91742731|NCT00282087|183379212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.708|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.||||
91742732|NCT00282087|183379213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.906|||||TWO_SIDED||||||Cox Proportional Hazards|||Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.||||
91742733|NCT00282087|183379214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.207|||||TWO_SIDED||||||Cox Proportional Hazards|||1988 FIGO Stage correlation with progression-free survival for patients on study treatment.||||
91742734|NCT00282087|183379215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.564|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.||||
91742735|NCT00405392|183379216|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91742736|NCT00405392|183379217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91742737|NCT00405392|183379218|SUPERIORITY_OR_OTHER|||||||0.9456|||||||t-test, 2 sided|||||||0.9456
91742738|NCT04301934|183379219|NON_INFERIORITY|The prevalence of UTI for the LASER group and vaginal estrogen group was calculated. Non-inferiority test using Farrington-Manning method was applied to test the risk difference against the pre-specified non-inferiority margin (20%).||||||0.034|||||||Farrington-Manning|||||||0.034
91742739|NCT02550288|183379226|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-36.3|||<|0.001|TWO_SIDED|95.0|-40.5|-32.2|||Constrained longitudinal data analysis|||||-32.2|-40.5|<0.001
91742740|NCT02550288|183379226|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.6|||<|0.001|TWO_SIDED|95.0|-14.9|-8.2|||Constrained longitudinal data analysis|||||-8.2|-14.9|<0.001
91742741|NCT02550288|183379226|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-39.9|||<|0.001|TWO_SIDED|95.0|-44.1|-35.8|||Constrained longitudinal data analysis|||||-35.8|-44.1|<0.001
91742742|NCT02550288|183379226|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.1|||<|0.001|TWO_SIDED|95.0|-13.5|-6.8|||Constrained longitudinal data analysis|||||-6.8|-13.5|<0.001
91742743|NCT00842153|183379249|SUPERIORITY_OR_OTHER|||||||0.1269||95.0||||P-value for Week 1|Fisher Exact|||||||0.1269
91742744|NCT00842153|183379249|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 2|Chi-squared|||||||<0.0001
91742745|NCT00842153|183379249|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||P-value for Week 4|Chi-squared|||||||0.0015
91500243|NCT00587483|182870487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.008|TWO_SIDED|95.0|0.32|0.84|||Regression, Logistic|||||0.84|0.32|0.008
91500244|NCT00587483|182870487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.424|TWO_SIDED|95.0|0.52|1.33|||Regression, Logistic|||||1.33|0.52|0.424
91500245|NCT04984993|182870493|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 0 versus alternative hypothesis: mu \>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.||||<0.001
91500246|NCT04984993|182870494|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.||||<0.001
91500247|NCT04984993|182870494|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.||||<0.001
91742746|NCT00402324|183379296|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||<0.001
91742747|NCT00402324|183379297|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||0.022
91742748|NCT00402324|183379298|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Fisher Exact|||||||0.100
91742749|NCT00402324|183379299|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
91742750|NCT00402324|183379300|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= TRT + Pooled Investigator + Baseline.||||||0.056
91742751|NCT00402324|183379302|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value for Total Cholesterol Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.657
91742752|NCT00402324|183379302|SUPERIORITY_OR_OTHER|||||||0.924||95.0||||P-value for Low Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.924
91742753|NCT00402324|183379302|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for High Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.122
91742754|NCT00402324|183379303|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value for Fasting Triglycerides Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.293
91742755|NCT00402324|183379304|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Fasting Blood Glucose Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.007
91742756|NCT00402324|183379305|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin Total Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.046
91742757|NCT00402324|183379306|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
91742758|NCT00402324|183379307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
91742759|NCT00402324|183379308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91742760|NCT01277822|183379309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin was 3 mmHg as Korean Food and Drug Administration (KFDA) guidance.|Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|7.7||0.1339|TWO_SIDED|95.0|-3.0|0.4|||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||0.4|-3.0|0.1339
91742761|NCT01277822|183379310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4478||||||No imputation for missing data was performed|t-test, 2 sided|||||||0.4478
91742762|NCT01277822|183379311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0717|||||||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||||0.0717
91742763|NCT01277822|183379312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8736|||||||t-test, 2 sided|No imputation for missing data was performed||||||0.8736
91742764|NCT01277822|183379313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
91500248|NCT04984993|182870494|OTHER|||||||0.89||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.||||0.890
91500249|NCT04984993|182870495|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||||||<0.001
91500250|NCT04984993|182870495|OTHER|||||||0.3327||||||Significance level of 0.025|t-test, 1 sided|||||||0.3327
91500251|NCT04984993|182870495|OTHER||||||>|0.999||||||Significance level of 0.025|t-test, 1 sided|||||||>0.999
91500252|NCT03108027|182870514|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6096|||||TWO_SIDED|90.0|0.538|0.6811|||Mixed Models Analysis|||||0.6811|0.5380|
91500253|NCT03108027|182870514|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6152|||||TWO_SIDED|90.0|0.5437|0.6868|||Mixed Models Analysis|||||0.6868|0.5437|
91742765|NCT01277822|183379314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
91742766|NCT01277822|183379315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6646|||||||Chi-squared|||||||0.6646
91500254|NCT03108027|182870514|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.0057|||||TWO_SIDED|90.0|-0.076|0.0647|||Mixed Models Analysis|||||0.0647|-0.0760|
91742767|NCT01277822|183379316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7911||||||Left ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.7911
91742768|NCT01277822|183379316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5933||||||Right ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.5933
91742769|NCT00997984|183379317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
91742770|NCT00997984|183379317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
91742771|NCT00997984|183379317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
91742772|NCT00997984|183379318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
91742773|NCT00997984|183379318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
91742774|NCT00997984|183379318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
91742775|NCT00997984|183379319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
91742776|NCT00997984|183379319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
91742777|NCT00997984|183379319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
91742778|NCT00997984|183379320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.099
91742779|NCT00997984|183379320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.596||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.596
91742780|NCT00997984|183379320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.023
91742781|NCT00997984|183379322|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
91742782|NCT00997984|183379322|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
91742783|NCT00997984|183379322|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
91742784|NCT00997984|183379323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.712
91742785|NCT00997984|183379323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.531||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.531
91742786|NCT00997984|183379323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.226
91742787|NCT00997984|183379324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.859
91742788|NCT00997984|183379324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.527
91742789|NCT00997984|183379324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.739
91742790|NCT00997984|183379325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
91742791|NCT00997984|183379325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.004
91742792|NCT00997984|183379325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.001
91742793|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.05|TWO_SIDED|95.0|1.8|10.8|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.8|1.8|<0.05
91742794|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-13.6|10.3|||Regression, Linear||The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.3|-13.6|<0.05
91500255|NCT03108027|182870515|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6206|||||TWO_SIDED|90.0|0.5335|0.7077|||Mixed Models Analysis|||||0.7077|0.5335|
91500256|NCT03108027|182870515|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.7347|||||TWO_SIDED|90.0|0.6469|0.8225|||Mixed Models Analysis|||||0.8225|0.6469|
91500257|NCT03108027|182870515|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.1141|||||TWO_SIDED|90.0|-0.197|-0.0311|||Mixed Models Analysis|||||-0.0311|-0.1970|
91500258|NCT03108027|182870516|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|72.1|||||TWO_SIDED|90.0|61.3|82.9|||Mixed Models Analysis|||Morning average PEF||82.9|61.3|
91500259|NCT03108027|182870516|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|86.9|||||TWO_SIDED|90.0|76.1|97.8|||Mixed Models Analysis|||Morning average PEF||97.8|76.1|
91500260|NCT03108027|182870516|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-14.8|||||TWO_SIDED|90.0|-25.6|-4.1|||Mixed Models Analysis|||Morning average PEF||-4.1|-25.6|
91500261|NCT03108027|182870516|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|73.1|||||TWO_SIDED|90.0|61.9|84.2|||Mixed Models Analysis|||Evening average PEF||84.2|61.9|
91500262|NCT03108027|182870516|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|58.7||||||90.0|47.5|69.9|||Mixed Models Analysis|||Evening average PEF||69.9|47.5|
91500263|NCT03108027|182870516|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|14.4|||||TWO_SIDED|90.0|3.3|25.5|||Mixed Models Analysis|||Evening average PEF||25.5|3.3|
91742795|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED|95.0|-5.4|6.5|||Regression, Linear||The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||6.5|-5.4|<0.05
91500264|NCT00003901|182870559|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.59||||0.007|TWO_SIDED|95.0|1.13|2.23|||Regression, Cox|||||2.23|1.13|0.007
91742796|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.05|TWO_SIDED|95.0|-8.9|1.1|||Regression, Linear||The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-8.9|<0.05
91742797|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.5|1.1|||Regression, Linear||The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-0.5|<0.05
91500265|NCT00003901|182870560|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.886|TWO_SIDED|95.0|0.69|1.54|||Regression, Cox|||||1.54|0.69|0.886
91500266|NCT00003901|182870561|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.63||||0.009|TWO_SIDED|95.0|1.13|2.36|||Regression, Cox|||||2.36|1.13|0.009
91500267|NCT00003901|182870562|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.332|TWO_SIDED|95.0|0.48|1.28|||Regression, Cox|||||1.28|0.48|0.332
91531256|NCT03259373|182939128|SUPERIORITY||Hazard Ratio (HR)|1.31|STANDARD_ERROR_OF_MEAN|0.172||0.122|TWO_SIDED|95.0|0.93|1.83|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.83|0.93|0.122
91500268|NCT00268996|182870578|SUPERIORITY_OR_OTHER||Adjusted percentage change|-11.717||||0.348|TWO_SIDED|95.0|-31.995|14.607|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||14.607|-31.995|0.348
91500269|NCT00268996|182870579|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.082||||0.22|TWO_SIDED|95.0|-0.214|0.049|||ANCOVA||Difference in adjusted means is shown (Darapladib 160 mg EC tablet - Placebo).|||0.049|-0.214|0.220
91500270|NCT00268996|182870580|SUPERIORITY_OR_OTHER||Adjusted percentage change|3.977||||0.751|TWO_SIDED|95.0|-18.331|32.379|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||32.379|-18.331|0.751
91500271|NCT00268996|182870581|SUPERIORITY_OR_OTHER||Adjusted percentage change|-60.737|||<|0.001|TWO_SIDED|95.0|-63.486|-57.78|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 26 (LOCF)||-57.780|-63.486|<0.001
91500272|NCT00268996|182870581|SUPERIORITY_OR_OTHER||Adjusted percentage change|-59.326|||<|0.001|TWO_SIDED|95.0|-62.21|-56.222|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 52 (LOCF)||-56.222|-62.210|<0.001
91742798|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-0.5|0.0|||Regression, Linear||The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.0|-0.5|<0.05
91500273|NCT00268996|182870582|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.253||||0.945|TWO_SIDED|95.0|-6.998|7.504|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||7.504|-6.998|0.945
91500274|NCT00268996|182870583|SUPERIORITY_OR_OTHER||Difference in adjusted means|-0.062||||0.898|TWO_SIDED|95.0|-1.009|0.886|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||0.886|-1.009|0.898
91500275|NCT00268996|182870584|SUPERIORITY_OR_OTHER||Difference in adjusted means|-5.165||||0.012|TWO_SIDED|95.0|-9.185|-1.145|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-1.145|-9.185|0.012
91500276|NCT00268996|182870585|SUPERIORITY_OR_OTHER||Difference in adjusted means|-1.967||||0.047|TWO_SIDED|95.0|-3.912|-0.022|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-0.022|-3.912|0.047
91500277|NCT00268996|182870586|SUPERIORITY_OR_OTHER||Adjusted percentage change|6.958||||0.487|TWO_SIDED|95.0|-11.568|29.364|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 26 (LOCF): Comparison between Placebo vs Darapladib 160 mg EC tablet||29.364|-11.568|0.487
91500278|NCT00268996|182870586|SUPERIORITY_OR_OTHER||Adjusted percentage change|12.255||||0.247|TWO_SIDED|95.0|-7.725|36.562|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 52 (LOCF): Comparison between Placebo Vs Darapladib 160 mg EC tablet||36.562|-7.725|0.247
91500279|NCT00268996|182870587|SUPERIORITY_OR_OTHER||Adjusted percentage change|-1.112||||0.687|TWO_SIDED|95.0|-6.363|4.433|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||4.433|-6.363|0.687
91500280|NCT00268996|182870587|SUPERIORITY_OR_OTHER||Adjusted percentage change|-3.237||||0.29|TWO_SIDED|95.0|-8.976|2.865|||ANOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|||2.865|-8.976|0.290
91500281|NCT00268996|182870588|SUPERIORITY_OR_OTHER||Adjusted percentage change|16.725||||0.022|TWO_SIDED|95.0|2.232|33.271|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||33.271|2.232|0.022
91500282|NCT00268996|182870588|SUPERIORITY_OR_OTHER||Adjusted percentage change|9.256||||0.252|TWO_SIDED|95.0|-6.136|27.172|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||27.172|-6.136|0.252
91531257|NCT03259373|182939129|SUPERIORITY||Hazard Ratio (HR)|0.98|STANDARD_ERROR_OF_MEAN|0.073||0.76|TWO_SIDED|95.0|0.85|1.13|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.13|0.85|0.760
91742799|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.05|TWO_SIDED|95.0|-4.9|3.4|||Regression, Linear||The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||3.4|-4.9|<0.05
91742800|NCT01539070|183379408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-8.4|4.1|||Regression, Linear||The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||4.1|-8.4|<0.05
91760128|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|||||TWO_SIDED|95.0|-4.94|2.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.17|-4.94|
91500283|NCT00268996|182870589|SUPERIORITY_OR_OTHER||Adjusted percentage change|15.449||||0.196|TWO_SIDED|95.0|-7.204|43.632|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26||43.632|-7.204|0.196
91500284|NCT00268996|182870589|SUPERIORITY_OR_OTHER||Adjusted percentage change|38.567||||0.024|TWO_SIDED|95.0|4.355|83.997|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52||83.997|4.355|0.024
91500285|NCT00268996|182870590|SUPERIORITY_OR_OTHER||Adjusted percentage change|-2.098||||0.79|TWO_SIDED|95.0|-16.303|14.517|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||14.517|-16.303|0.790
91500286|NCT00268996|182870590|SUPERIORITY_OR_OTHER||Adjusted percentage change|1.986||||0.818|TWO_SIDED|95.0|-13.807|20.673|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||20.673|-13.807|0.818
91742801|NCT01539070|183379409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.05|TWO_SIDED|95.0|-29.1|5.5|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.||5.5|-29.1|<0.05
91742802|NCT01539070|183379409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.2|0.5|||Regression, Linear||The change in mean sleep time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.5|-0.2|<0.05
91742803|NCT01539070|183379409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-4.4|1.1|||Regression, Linear||The change in mean screen time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-4.4|<0.05
91742804|NCT01539070|183379411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.05|TWO_SIDED|95.0|-0.04|0.35|||Regression, Linear|||In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.35|-0.04|<0.05
91742805|NCT02689206|183379412|OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.31|1.45|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 10 mg arm from Placebo along with 95 percent CI are presented.|||1.45|-0.31|
91742806|NCT02689206|183379412|OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 15 mg arm from Placebo along with 95 percent CI are presented.|||1.42|-0.40|
91742807|NCT02689206|183379412|OTHER||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|0.59|2.35|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 25 mg arm from Placebo along with 95 percent CI are presented.|||2.35|0.59|
91742808|NCT02689206|183379412|OTHER||Mean Difference (Final Values)|1.67|||||TWO_SIDED|95.0|0.77|2.57|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 30 mg arm from Placebo along with 95 percent CI are presented.|||2.57|0.77|
91742809|NCT02520388|183379452|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
91742810|NCT02520388|183379453|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
91742811|NCT01479764|183379461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.059|||Pearson's Chi-square test|||Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.||0.059|0.000|<0.0001
91742812|NCT01479764|183379462|SUPERIORITY_OR_OTHER||Estimated Ratio of Geometric Means|0.83||||0.021|TWO_SIDED|95.0|0.71|0.97|||ANCOVA|Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index \& length of surgical procedure||Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.||0.97|0.71|0.021
91742813|NCT03711370|183379465|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by bottle type interactions on infant intake during post-test feeding observations.||||||0.76||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.76
91742814|NCT03711370|183379466|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by-bottle type interactions on maternal sensitivity during post-test feeding observations.||||||0.64||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.64
91500287|NCT00268996|182870591|SUPERIORITY_OR_OTHER||Adjusted percentage change|-0.252||||0.98|TWO_SIDED|95.0|-18.151|21.561|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||21.561|-18.151|0.980
91500288|NCT00268996|182870591|SUPERIORITY_OR_OTHER||Adjusted percentage change|-8.585||||0.663|TWO_SIDED|95.0|-39.007|37.012|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||37.012|-39.007|0.663
91742815|NCT03711370|183379467|OTHER|General linear models were used to compare post-test weight-for-length z-scores (WLZ).||||||0.02||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|These models controlled for baseline values (i.e., baseline WLZ), infant sex and age, and whether the assessment was in-person or remote.||||||0.02
91500289|NCT00268996|182870593|SUPERIORITY_OR_OTHER||Adjusted treatment Difference|1.758||||0.811|TWO_SIDED|95.0|-12.675|16.192|||ANCOVA||Difference in adjusted means are shown (Darapladib 160mg EC tablet once daily - Placebo).|For vessel volume||16.192|-12.675|0.811
91500290|NCT00268996|182870593|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.627||||0.708|TWO_SIDED|95.0|-11.171|16.425|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet once daily - Placebo).|For lumen volume||16.425|-11.171|0.708
91500291|NCT00268996|182870594|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.012||||0.873|TWO_SIDED|95.0|-0.16|0.136||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.136|-0.160|0.873
91500292|NCT00268996|182870594|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.048||||0.756|TWO_SIDED|95.0|-0.258|0.354|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.354|-0.258|0.756
91500293|NCT00268996|182870594|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.061||||0.687|TWO_SIDED|95.0|-0.237|0.36|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean lumen area||0.360|-0.237|0.687
91500294|NCT00268996|182870595|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.584||||0.854|TWO_SIDED|95.0|-6.819|5.65|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue volume||5.650|-6.819|0.854
91500295|NCT00268996|182870595|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.926||||0.418|TWO_SIDED|95.0|-2.748|6.6||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty volume||6.600|-2.748|0.418
91742816|NCT03711370|183379468|OTHER|General linear models were used to compare post-test waist circumference for the Clear versus Opaque groups.||||||0.07||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e., waist circumference), infant sex and age, and whether the assessment was in-person or remote.||||||0.07
91742817|NCT03711370|183379469|OTHER|General linear models were used to compare post-test triceps skinfold z-scores for the Clear versus Opaque groups.||||||0.7||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e.,triceps skinfolds z-scores), infant sex and age, and whether the assessment was in-person or remote.||||||0.70
91500296|NCT00268996|182870596|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.0||||0.021|TWO_SIDED|95.0|0.299|3.701|||ANOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue as % of VH plaque||3.701|0.299|0.021
91500297|NCT00268996|182870596|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.739||||0.54|TWO_SIDED|95.0|-1.635|3.114|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty as percentage of VH plaque||3.114|-1.635|0.540
91500298|NCT00862745|182870619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustment for multiple comparisons, threshold for significance is P \< .05|ANCOVA|Mean difference=Drug A minus Drug B||Null hypothesis: fesoterodine treatment is not associated with greater reduction in urgency incontinence frequency compared to placebo in women diagnosed using the 3IQ||||<0.001
91500299|NCT01414075|182870627|OTHER|||||||0.0757||||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0757
91500300|NCT01414075|182870627|OTHER|||||||0.063||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0630
91500301|NCT01414075|182870627|OTHER|||||||0.8653||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8653
91500302|NCT01414075|182870627|OTHER|||||||0.8982||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8982
91500303|NCT00867009|182870673|SUPERIORITY_OR_OTHER||Percentage of participants with response|38.5|||||TWO_SIDED|80.0|32.3|45.09||||||||45.09|32.30|
91500304|NCT00867009|182870674|SUPERIORITY_OR_OTHER||Median number of months|5.82|||||TWO_SIDED|80.0|4.4|6.7||||||||6.70|4.40|
91742818|NCT01740687|183379497|OTHER||95% upper Bayesian credible interval|1.23|||||||||||||%|predetermined study success threshold of 2.1% at 1 year||||
91742819|NCT01740687|183379498|OTHER||95% upper Bayesian credible interval|1.33|||||||||||||%|predetermined study success threshold of 2.8% at 3 years||||
91500305|NCT00867009|182870675|SUPERIORITY_OR_OTHER||Percentage of participants with response|45.0|||||TWO_SIDED|80.0|39.0|51.0||||||||51|39|
91500306|NCT00867009|182870676|SUPERIORITY_OR_OTHER||Percentage of participants with response|59.6|||||TWO_SIDED|80.0|53.06|65.94||||||||65.94|53.06|
91500307|NCT00147199|182870677|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate|20.0||||0.00044|TWO_SIDED|95.0|8.0|32.8|||ANCOVA|Lowest rank was assigned for death, discontinuation due to disease progression, and for patients who initiated additional approved PAH therapy.||Sample size was calculated based on the primary endpoint; change in 6MWD at Week 12. Assuming a between-treatment difference of 35m, a standard deviation of 75m, and a type I (alpha) error of 0.05 (i.e., two-sided p-value of less than 0.05), in order to have 90% power to detect this difference, 100 subjects per treatment group were required for this trial (total n=200). This allowed for a dropout rate of 10% as 110 subjects per group was planned.||32.8|8.0|0.00044
91500308|NCT00147199|182870679|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.623|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank sum test|||||0.0|-0.5|0.623
91742820|NCT00200967|183379539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.0||0.99||95.0|-14.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for AM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design. A sample size of 40 participants per genotype was required to detect a difference of 25 L/min in AM PEF (and relevant effect sizes for secondary outcomes) with a two-sided, 0.05 significance level test with 90% statistical power and a 15% drop-out rate.||14|-14|0.99
91500309|NCT00147199|182870680|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.807|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for 16 inhaled treprostinil subjects and 9 placebo subjects without values reported at Week 12|Wilcoxon rank sum test|||||0.0|0.0|0.807
91500310|NCT00147199|182870681|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.7||||0.007|TWO_SIDED|95.0|4.0|24.8|||ANCOVA|||||24.8|4.0|0.007
91500311|NCT00147199|182870682|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|18.5||||0.0003|TWO_SIDED|95.0|8.5|28.3|||Wilcoxon rank sum test|||||28.3|8.5|0.0003
91500312|NCT00147199|182870683|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-4.0||||0.027|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon rank sum test|||Global Score||0|-8.0|0.027
91531258|NCT03259373|182939130|SUPERIORITY||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.072||0.76|TWO_SIDED|95.0|0.86|1.14|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.14|0.86|0.760
91500313|NCT00147199|182870683|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-2.0||||0.037|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon rank sum test|||Physical Dimension||0.0|-3.0|0.037
91531259|NCT03259373|182939131|SUPERIORITY||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.052||0.616|TWO_SIDED|95.0|0.88|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.88|0.616
91742821|NCT00200967|183379540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.82||95.0|-15.0|12.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||12|-15|0.82
91742822|NCT00200967|183379541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.31||95.0|-1.6|0.5|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PEF variability.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.5|-1.6|0.31
91742823|NCT00200967|183379542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.09||95.0|-0.02|0.07|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for asthma symptoms.|A mixed-effects linear model was attempted but could not converge because very few symptoms were recorded, so a nonparametric analysis was applied.||0.07|-0.02|0.09
91500314|NCT00147199|182870683|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-1.0||||0.173|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon rank sum test|||Emotional Dimension Score||0.0|-2.0|0.173
91500315|NCT00147199|182870685|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-167.0||||0.001|TWO_SIDED|95.0|-333.0|-64.0|||Wilcoxon rank sum test|||||-64|-333|0.001
91500316|NCT00453921|182870808|OTHER||||||<|0.04||||||For active therapy/placebo relative to both placebo|Kruskal-Wallis|||||||<0.04
91500317|NCT00453921|182870810|EQUIVALENCE|Looking for statistical difference, p \< .01, between groups looking at change scores|||||<|0.05|||||||ANOVA|||||||<0.05
91500318|NCT00453921|182870811|EQUIVALENCE|group differences|||||<|0.05|||||||ANCOVA|||||||<0.05
91742824|NCT00200967|183379543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.25||95.0|-0.1|0.2|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for rescue medication use.|A mixed-effects linear model was attempted but could not converge because very few usages of rescue medications were recorded, so a nonparametric analysis was applied.||0.2|-0.1|0.25
91500319|NCT00453921|182870814|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91500320|NCT00453921|182870814|SUPERIORITY||||||<|0.05||||||a priopr|ANCOVA|||||||<0.05
91500321|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL versus \[v.\] \>1.5 mg/dL).||||||<0.001
91742825|NCT00200967|183379544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.34||95.0|-0.1|0.03|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.03|-0.10|0.34
91742826|NCT00200967|183379545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.91||95.0|-0.08|0.07|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.07|-0.08|0.91
91742827|NCT00200967|183379546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.93||95.0|-15.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||14|-15|0.93
91742828|NCT00200967|183379547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.13||95.0|-0.04|0.31|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for eNO.|A mixed-effects linear model was applied to the natural logarithm of eNO to account for the repeated measurements within each treatment period of the crossover design.||0.31|-0.04|0.13
91742829|NCT00200967|183379548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.79||95.0|-0.56|0.43|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for EBC.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.43|-0.56|0.79
91742830|NCT00200967|183379549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.45||0.004||95.0|0.43|2.21|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for methacholine PC20.|A mixed-effects linear model was applied to the base-2 logarithm of the methacholine PC20 to account for the repeated measurements within each treatment period of the crossover design.||2.21|0.43|0.004
91742831|NCT00200967|183379550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89||95.0|-0.23|0.26|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for ACQ.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.26|-0.23|0.89
91742832|NCT00928187|183379551|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|differences in proportions|5.6|||||TWO_SIDED|95.0|-5.1|16.4||||||||16.4|-5.1|
91742833|NCT00928187|183379551|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|difference in proportions|6.1|||||TWO_SIDED|95.0|-4.5|16.7||||||||16.7|-4.5|
91742834|NCT00928187|183379556|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
91742835|NCT00928187|183379557|SUPERIORITY_OR_OTHER|||||||0.26|||||||Chi-squared|||||||0.26
91742836|NCT00928187|183379558|SUPERIORITY_OR_OTHER|||||||0.13|||||||Chi-squared|||||||0.13
91742837|NCT00336284|183379597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91742838|NCT00336284|183379598|NON_INFERIORITY_OR_EQUIVALENCE|Sample size of the study is based on the safety endpoint and based on a Blackwelder type test of non inferiority with the standard design criteria: Type I error (one-sided), statistical power of 80%, and 2:1 randomization. The evaluation of the primary safety endpoint was based on an exact binomial non-inferiority test comparing the proportions of patient deaths, strokes or surgical interventions.||||||0.005||95.0|||||Exact binomial test for non-inferiority|1-sided||||||0.005
91742839|NCT00336284|183379599|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
91742840|NCT03462641|183379605|SUPERIORITY||t-value|-2.15|STANDARD_DEVIATION|1.32||0.0407|TWO_SIDED|||||Alpha was set to 0.05.|Paired-Sample Two-Tailed T-Test|||Null hypothesis was no difference in PIGD score within participants before and after flumazenil infusion.||||0.0407
91742841|NCT03462641|183379605|OTHER||F-value|2.861||||0.103|TWO_SIDED|||||"P value is given for the Drug\*Time term, which represents interaction between time relative to administration (before infusion vs after infusion) and treatment administered (placebo vs flumazenil).~Alpha was set to 0.05."|Repeated Measures ANCOVA|||Null hypothesis is that there is no significant interaction between drug and time of administration (pre vs. post infusion).||||0.103
91760129|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-3.98|3.08||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.08|-3.98|
91760130|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-3.34|3.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.82|-3.34|
91760131|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.75|4.28||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.28|-2.75|
91742842|NCT03462641|183379606|OTHER||Standardized β Coefficient|0.6||||2.9e-07|TWO_SIDED|95.0|0.13|1.07||P value presented is for model comparison between interaction model and random intercept model.|Mixed Models Analysis|||A pair of maximum likelihood mixed linear models were estimated. The first was a random intercept model that merely accounted for individual differences in PIGD score before infusion. The second was an interaction model, that added an interaction term between baseline FMZ PET binding and PIGD score change from pre to post infusion. The interaction model was compared against the random intercept model to determine significance of the interaction using likelihood ratio goodness of fit test.||1.07|0.13|0.00000029
91742843|NCT03938103|183379607|OTHER|||||||0.101|||||||Mixed Models Analysis|||||||0.101
91742844|NCT03938103|183379608|OTHER|||||||0.383|||||||Mixed Models Analysis|||||||0.383
91742845|NCT03248531|183379648|OTHER||Mean posterior difference|31.2|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|11.0|50.4|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.||50.4|11.0|
91742846|NCT03248531|183379648|OTHER||Mean posterior difference|-2.2|STANDARD_DEVIATION|10.6|||TWO_SIDED|60.0|-11.2|6.6|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.||6.6|-11.2|
91742847|NCT03248531|183379648|OTHER||Pr [Diff>0%] (%)|99.8|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
91742848|NCT03248531|183379648|OTHER||Pr[Diff > 0%](%)|42.1|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
91742849|NCT04660552|183379712|EQUIVALENCE|The post treatment cars scores of active and sham group will be statistically different as measured by independent sample t-test with p\<.05|Mean Difference (Net)|7.23|STANDARD_DEVIATION|4.2||0.01|TWO_SIDED|95.0|2.357|12.107|||t-test, 2 sided|||||12.107|2.357|0.01
91742850|NCT03012828|183379713|OTHER|The model was used for predicting population average and 90% 2-sided bootstrapped CI of the baseline-adjusted difference between active and placebo at each time point bound at clinically relevant concentrations.|Slope|-0.0077||||0.4727|TWO_SIDED|90.0|-0.0255|0.0101|||Mixed Models Analysis||The primary mixed effects model analysis revealed a nearly flat dQTcF - plasma concentration gradient|The primary analysis used a mixed-effects model to explore the relationship between the time-matched, baseline-adjusted QTcF (delta (d)QTcF) and moxidectin concentrations. dQTcF was a dependent variable and treatment, time point, and treatment by time point interaction as the independent variables with baseline QTcF as a covariate and time-matched concentrations of moxidectin as a covariate with random effects of intercept and slope for each subject.Concentrations of zero were used for placebo.||0.0101|-0.0255|0.4727
91742851|NCT01637584|183379744|SUPERIORITY_OR_OTHER||||||<|0.001||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38||||<0.001
91742852|NCT01637584|183379744|SUPERIORITY_OR_OTHER|||||||0.039||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;||||0.039
91742853|NCT01637584|183379744|SUPERIORITY_OR_OTHER|||||||0.701||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report||||0.701
91742854|NCT01637584|183379744|SUPERIORITY_OR_OTHER|||||||1||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< REM: No cluster size, coordinates, or brain regions to report||||1.00
91742855|NCT01637584|183379744|SUPERIORITY_OR_OTHER|||||||0.03||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;||||0.03
91742856|NCT01637584|183379744|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42||||0.01
91742857|NCT02110485|183379751|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91742858|NCT02110485|183379752|OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.27
91742859|NCT02110485|183379753|OTHER|||||||0.67|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.67
91742860|NCT02110485|183379754|OTHER|||||||0.17|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.17
91742861|NCT02110485|183379755|OTHER|||||||0.84|||||||Fisher Exact|||||||.84
91742862|NCT02110485|183379756|OTHER|||||||0.99|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.99
91742863|NCT00177294|183379765|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Regression, Logistic|||We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.||||0.14
91742864|NCT02473471|183379768|OTHER|The sample size was calculated based on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups (effect size= 0.8), the power analysis yielded 28 subjects per group at a conventional alpha level (p = 0.05) and desired power (1 - β) of 0.90||||||0.77|||||||t-test, 2 sided|||||||0.77
91742865|NCT02473471|183379769|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
91742866|NCT02473471|183379770|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
91742867|NCT02473471|183379771|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
91742868|NCT02473471|183379772|OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
91742869|NCT02473471|183379773|OTHER|||||||0.74||||||There was no significant difference in tooth movement between control and MOP sides from baseline to 1st, 2nd and 3rd months. P Value \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.74
91705276|NCT03240406|183305045|SUPERIORITY||Mean Difference (Net)|-1.43||||0.042|TWO_SIDED|95.0|-2.81|-0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.06|-2.81|0.042
91705277|NCT03240406|183305046|SUPERIORITY||Slope|-16.0||||0.031|TWO_SIDED|95.0|-31.0|-1.5||Linear mixed-effects model adjusted for adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of processing speed over years between MHD Arm and Comparison Arm.|||-1.5|-31|0.031
91705278|NCT03240406|183305047|SUPERIORITY||Slope|0.12||||0.55|TWO_SIDED|95.0|-0.27|0.51||Linear mixed-effects model adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of error distance over years between MHD Arm vs Comparison Arm|||0.51|-0.27|0.55
91705279|NCT03240406|183305048|SUPERIORITY||Slope|-0.018||||0.846|TWO_SIDED|95.0|-0.09|0.054||Generalized Estimating equation Poisson model adjusted for arm, year, weekday vs weekend, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Generalized Estimating Equation|Adjusted for arm, year, wkday/wknd, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Difference in the slopes of log-transformed error rates over years between the MHD Arm and the Comparison Arm.|||0.054|-0.090|0.846
91705280|NCT01160380|183305069|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.289
91705281|NCT01160380|183305069|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and Day 28||||<0.001
91705282|NCT01160380|183305069|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and day 28||||<0.002
91705283|NCT01160380|183305069|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the armodafinil arm||||0.449
91705284|NCT01160380|183305070|SUPERIORITY_OR_OTHER|||||||0.954|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.954
91705285|NCT01160380|183305070|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.007
91705286|NCT01160380|183305070|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.369
91705287|NCT01160380|183305070|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm||||0.973
91705288|NCT01160380|183305071|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms at day 28||||0.699
91705289|NCT01160380|183305071|SUPERIORITY_OR_OTHER|||||||0.984|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.984
91705290|NCT01160380|183305071|SUPERIORITY_OR_OTHER|||||||0.239|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.239
91705291|NCT01160380|183305071|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.089
91705292|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test||||0.636
91705293|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test||||0.531
91705294|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test||||0.037
91705295|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.656|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test||||0.656
91705296|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.028
91705297|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.805
91705298|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.692|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.692
91705299|NCT01160380|183305072|SUPERIORITY_OR_OTHER|||||||0.863|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.863
91705300|NCT01160380|183305073|SUPERIORITY_OR_OTHER|||||||0.559|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for Day 28 of treatment- FACIT-F total||||0.559
91705301|NCT01160380|183305073|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total||||<0.001
91705302|NCT01160380|183305073|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total||||0.192
91705303|NCT01160380|183305073|SUPERIORITY_OR_OTHER|||||||0.495|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total||||0.495
91705304|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS anxiety||||0.945
91705305|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS depression||||0.316
91705306|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety||||0.005
91705307|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.005
91705308|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety||||0.001
91742870|NCT02473471|183379774|OTHER|||||||0.59|||||||t-test, 2 sided|||Root length at baseline.||||0.59
91742871|NCT02473471|183379774|OTHER|||||||0.48|||||||t-test, 2 sided|||Root length at 3 months||||0.48
91742872|NCT02473471|183379775|OTHER|||||||0.388|||||||t-test, 2 sided|||Immediate after intervention||||0.388
91705309|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.315
91705310|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety||||0.933
91705311|NCT01160380|183305074|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression||||0.378
91705312|NCT01160380|183305075|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for Day 28 of treatment -ESS||||0.840
91705313|NCT01160380|183305075|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS||||0.050
91705314|NCT01160380|183305075|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 and Day 28 of treatment for the Armodafinil arm- ESS||||0.051
91705315|NCT01160380|183305075|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.635
91705316|NCT01153009|183305099|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.224|TWO_SIDED|95.0|-3.86|0.91||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.91|-3.86|0.224
91705317|NCT01153009|183305099|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.21||0.023|TWO_SIDED|95.0|-5.12|-0.38||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues for this dose.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-0.38|-5.12|0.023
91705318|NCT01153009|183305099|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-6.46|-1.69|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.69|-6.46|<0.001
91705319|NCT01153009|183305100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.348|TWO_SIDED|95.0|0.786|1.984|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.984|0.786|0.348
91705320|NCT01153009|183305100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.257||||0.332|TWO_SIDED|95.0|0.792|1.994||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.792|0.332
91705321|NCT01153009|183305100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.991||||0.004|TWO_SIDED|95.0|1.25|3.171|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.171|1.250|0.004
91705322|NCT01153009|183305101|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4|TWO_SIDED|95.0|-0.39|0.16|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.16|-0.39|0.400
91705323|NCT01153009|183305101|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.139||0.177|TWO_SIDED|95.0|-0.46|0.08|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.08|-0.46|0.177
91705324|NCT01153009|183305101|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.139||0.014|TWO_SIDED|95.0|-0.61|-0.07|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.07|-0.61|0.014
91705325|NCT01153009|183305102|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|2.286||0.684|TWO_SIDED|95.0|-3.58|5.45|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||5.45|-3.58|0.684
91705326|NCT01153009|183305102|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.419||0.797|TWO_SIDED|95.0|-5.4|4.15|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||4.15|-5.40|0.797
91705327|NCT01153009|183305102|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|2.278||0.078|TWO_SIDED|95.0|-8.54|0.45|||Mixed model for repeated mesurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||0.45|-8.54|0.078
91705328|NCT01153009|183305103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.053||||0.845|TWO_SIDED|95.0|0.625|1.775|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.775|0.625|0.845
91705329|NCT01153009|183305103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.503|TWO_SIDED|95.0|0.713|1.994|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.713|0.503
91705330|NCT01153009|183305103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.098||||0.728|TWO_SIDED|95.0|0.648|1.86|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.860|0.648|0.728
91705331|NCT01153009|183305104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.111||0.962|TWO_SIDED|95.0|-2.24|2.13|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||2.13|-2.24|0.962
91500322|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91531260|NCT03259373|182939132|SUPERIORITY||Hazard Ratio (HR)|1.0|STANDARD_ERROR_OF_MEAN|0.072||0.992|TWO_SIDED|95.0|0.87|1.15|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.15|0.87|0.992
91531261|NCT03259373|182939133|SUPERIORITY||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.029||0.808|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||||1.07|0.95|0.808
91742873|NCT02473471|183379775|OTHER|||||||0.092|||||||t-test, 2 sided|||1 hour after intervention||||0.092
91742874|NCT02473471|183379775|OTHER|||||||0.1|||||||t-test, 2 sided|||12 hour after intervention||||0.100
91742875|NCT02473471|183379775|OTHER|||||||0.302|||||||t-test, 2 sided|||Day 1 after intervention||||0.302
91742876|NCT02473471|183379775|OTHER|||||||0.582|||||||t-test, 2 sided|||Day 3 after intervention||||0.582
91742877|NCT02473471|183379775|OTHER|||||||0.743|||||||t-test, 2 sided|||Day 5 after intervention||||0.743
91742878|NCT02473471|183379775|OTHER|||||||0.809|||||||t-test, 2 sided|||Day 7 after intervention||||0.809
91742879|NCT02473471|183379776|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 1||||0.09
91500323|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91531262|NCT03259373|182939134|SUPERIORITY||Standardized Mean Difference (%)|-0.51|STANDARD_ERROR_OF_MEAN|0.027||0.853|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.853
91742880|NCT02473471|183379776|OTHER|||||||0.29|||||||t-test, 2 sided|||Day 3||||0.29
91742881|NCT02473471|183379776|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 5||||0.57
91742882|NCT02473471|183379776|OTHER|||||||0.82|||||||t-test, 2 sided|||Day 7||||0.82
91531263|NCT03259373|182939135|SUPERIORITY||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.066||0.303|TWO_SIDED|95.0|0.82|1.06|||fixed-effect meta-analysis|||||1.06|0.82|0.303
91531264|NCT03259373|182939136|SUPERIORITY||Hazard Ratio (HR)|1.03|STANDARD_ERROR_OF_MEAN|0.063||0.649|TWO_SIDED|95.0|0.91|1.16|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.16|0.91|0.649
91742883|NCT02473471|183379777|OTHER|||||||0.27|||||||t-test, 2 sided|||Day 1||||0.27
91742884|NCT02473471|183379777|OTHER|||||||0.37|||||||t-test, 2 sided|||Day 3||||0.37
91742885|NCT02473471|183379777|OTHER|||||||0.33|||||||t-test, 2 sided|||Day 5||||0.33
91742886|NCT02473471|183379777|OTHER||||||>|0.05|||||||t-test, 2 sided|||Day 7||||> 0.05
91742887|NCT02473471|183379778|OTHER|||||||0.05|||||||t-test, 2 sided|||Day 1||||0.05
91742888|NCT02473471|183379778|OTHER|||||||0.47|||||||t-test, 2 sided|||Day 3||||0.47
91742889|NCT02473471|183379778|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 5||||0.09
91742890|NCT02473471|183379778|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
91742891|NCT02473471|183379779|OTHER|||||||0.18|||||||t-test, 2 sided|||Day 1||||0.18
91742892|NCT02473471|183379779|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 3||||0.57
91742893|NCT02473471|183379779|OTHER|||||||0.3|||||||t-test, 2 sided|||Day 5||||0.30
91742894|NCT02473471|183379779|OTHER|||||||0.56|||||||t-test, 2 sided|||Day 7||||0.56
91742895|NCT02473471|183379780|OTHER||||||<|0.05|||||||Descriptive statistics|||||||< 0.05
91742896|NCT01181804|183379797|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|1.07|1.15|||ANOVA|||||1.15|1.07|
91742897|NCT01181804|183379798|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.32|1.54|||ANOVA|||||1.54|1.32|
91742898|NCT01181804|183379799|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.1|||||TWO_SIDED|95.0|1.06|1.14|||ANOVA|||||1.14|1.06|
91760132|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-4.88|2.27||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.27|-4.88|
91760133|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|-1.32|5.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.82|-1.32|
91500324|NCT00174915|182870815|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|25.7||||||97.5|16.7|34.7||||||||34.7|16.7|
91742899|NCT01181804|183379800|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.15|||||TWO_SIDED|90.0|1.09|1.21|||ANOVA|||||1.21|1.09|
91742900|NCT00191945|183379827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-11.0|-4.8|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)|||-4.8|-11.0|<0.001
91742901|NCT00191945|183379828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.5|-3.6|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-3.6|-9.5|<0.001
91742902|NCT00191945|183379829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|STANDARD_ERROR_OF_MEAN|1.5||0.0009||95.0|-8.2|-2.2|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-2.2|-8.2|0.0009
91742903|NCT00191945|183379830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.3||0.0033||95.0|-6.4|-1.3|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-1.3|-6.4|0.0033
91742904|NCT00191945|183379831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.1||0.013||95.0|-4.9|-0.6||P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.|Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-0.6|-4.9|0.013
91760134|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.89|1.87||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-5.89|
91760135|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-2.41|5.4||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.40|-2.41|
91760136|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.45|||||TWO_SIDED|95.0|-2.44|5.34||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.34|-2.44|
91760137|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||||TWO_SIDED|95.0|-1.98|5.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.76|-1.98|
91760138|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-3.16|4.61||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.61|-3.16|
91500325|NCT00174915|182870815|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|42.7||||||97.5|34.0|51.3||||||||51.3|34.0|
91531265|NCT03259373|182939137|SUPERIORITY||Standardized Mean Difference (%)|-0.4998|STANDARD_ERROR_OF_MEAN|0.009||0.587|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.587
91760139|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18|||||TWO_SIDED|95.0|0.29|8.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.06|0.29|
91500326|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91742905|NCT00191945|183379834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.7|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-15.1|-6.2||P-value is for the difference between groups in the change from 12 weeks minus baseline.|Mixed Models Analysis|mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment\*visit interaction|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.|||-6.2|-15.1|<0.001
91742906|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.81||95.0|-3.39|4.33||P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.33|-3.39|0.810
91742907|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.96||||0.243||95.0|-1.35|5.29||P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.29|-1.35|0.243
91742908|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.56||||0.419||95.0|-2.26|5.39||P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.39|-2.26|0.419
91742909|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.41|||<|0.001||95.0|4.27|12.55||P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||12.55|4.27|<0.001
91742910|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.39||||0.042||95.0|0.13|6.65||P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.65|0.13|0.042
91742911|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.323||95.0|-4.06|1.35||P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||1.35|-4.06|0.323
91742912|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.452||95.0|-1.49|3.34||P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||3.34|-1.49|0.452
91742913|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.91||95.0|-2.59|2.9||P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||2.90|-2.59|0.910
91742914|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.006||95.0|1.04|6.08||P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.08|1.04|0.006
91742915|NCT00191945|183379835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.541||95.0|-2.21|4.19||P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.19|-2.21|0.541
91742916|NCT02063984|183379842|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.11|1.56|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||1.56|.11|
91742917|NCT02063984|183379843|SUPERIORITY||Ratio of means|1.56|||||TWO_SIDED|95.0|0.79|3.07|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||3.07|.79|
91742918|NCT02063984|183379844|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.18|4.82||||||CM+No WMT is the comparison condition||4.82|.18|
91742919|NCT02063984|183379845|SUPERIORITY||Ratio of means|0.92|||||TWO_SIDED|95.0|0.33|2.54|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||2.54|.33|
91742920|NCT02063984|183379846|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.45||||||Strategy 1 is the comparison condition||2.45|.45|
91531266|NCT03259373|182939137|SUPERIORITY||Standardized Mean Difference (%)|-0.4655|STANDARD_ERROR_OF_MEAN|0.009||0.613|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.613
91500327|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91742921|NCT02063984|183379846|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.84|6.2||||||Strategy 1 is the comparison condition||6.20|.84|
91742922|NCT02063984|183379846|SUPERIORITY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.23|1.13||||||Strategy 1 is the comparison condition||1.13|.23|
91742923|NCT02063984|183379847|SUPERIORITY||Ratio of means|1.21|||||TWO_SIDED|95.0|0.76|1.92||||||Strategy 1 is the comparison condition||1.92|.76|
91742924|NCT02063984|183379847|SUPERIORITY||Ratio of means|0.76|||||TWO_SIDED|95.0|0.49|1.18||||||Strategy 1 is the comparison condition||1.18|.49|
91742925|NCT02063984|183379847|SUPERIORITY||Ratio of means|1.33|||||TWO_SIDED|95.0|0.83|2.15||||||Strategy 1 is the comparison condition||2.15|.83|
91742926|NCT01831466|183379893|SUPERIORITY_OR_OTHER||Difference in response rates|3.9|STANDARD_ERROR_OF_MEAN|6.36||0.5425|TWO_SIDED|80.0|-4.3|12.0|||Cochran-Mantel-Haenszel|||||12.0|-4.3|0.5425
91742927|NCT01831466|183379893|SUPERIORITY_OR_OTHER||Difference in response rates|-4.0|STANDARD_ERROR_OF_MEAN|5.87||0.4976|TWO_SIDED|80.0|-11.5|3.5|||Cochran-Mantel-Haenszel|||||3.5|-11.5|0.4976
91742928|NCT01831466|183379893|SUPERIORITY_OR_OTHER||Difference in response rates|3.3|STANDARD_ERROR_OF_MEAN|6.36||0.6039|TWO_SIDED|80.0|-4.9|11.5|||Cochran-Mantel-Haenszel|||||11.5|-4.9|0.6039
91742929|NCT01831466|183379893|SUPERIORITY_OR_OTHER||Difference in response rate|4.0|STANDARD_ERROR_OF_MEAN|6.34||0.5279|TWO_SIDED|80.0|-4.1|12.1|||Cochran-Mantel-Haenszel|||||12.1|-4.1|0.5279
91742930|NCT01831466|183379894|SUPERIORITY_OR_OTHER||Difference in response rates|10.8|STANDARD_ERROR_OF_MEAN|5.99||0.071|TWO_SIDED|80.0|3.1|18.5|||Cochran-Mantel-Haenszel|||||18.5|3.1|0.0710
91742931|NCT01831466|183379894|SUPERIORITY_OR_OTHER||Difference in response rates|-1.2|STANDARD_ERROR_OF_MEAN|5.2||0.8175|TWO_SIDED|80.0|-7.9|5.5|||Cochran-Mantel-Haenszel|||||5.5|-7.9|0.8175
91742932|NCT01831466|183379894|SUPERIORITY_OR_OTHER||Difference in response rates|11.0|STANDARD_ERROR_OF_MEAN|5.63||0.0513|TWO_SIDED|80.0|3.8|18.2|||Cochran-Mantel-Haenszel|||||18.2|3.8|0.0513
91742933|NCT01831466|183379894|SUPERIORITY_OR_OTHER||Difference in response rates|6.7|STANDARD_ERROR_OF_MEAN|5.23||0.2021|TWO_SIDED|80.0|0.0|13.4|||Cochran-Mantel-Haenszel|||||13.4|-0.0|0.2021
91742934|NCT02131662|183379931|SUPERIORITY_OR_OTHER||Percentage difference|58.28|||||TWO_SIDED|95.0|44.55|70.94||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||70.94|44.55|
91500328|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91531267|NCT03259373|182939137|SUPERIORITY||Standardized Mean Difference (%)|0.598|STANDARD_ERROR_OF_MEAN|0.009||0.515|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.515
91742935|NCT02131662|183379931|SUPERIORITY_OR_OTHER||Percentage difference|52.37|||||TWO_SIDED|95.0|38.8|65.42||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||65.42|38.8|
91742936|NCT02131662|183379931|SUPERIORITY_OR_OTHER||Percentage difference|54.01|||||TWO_SIDED|95.0|40.41|66.95||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||66.95|40.41|
91742937|NCT02131662|183379931|SUPERIORITY_OR_OTHER||Percentage difference|28.28|||||TWO_SIDED|95.0|15.92|41.5||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||41.5|15.92|
91742938|NCT01433042|183379983|SUPERIORITY_OR_OTHER||percentage|98.0||||||||||since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|percentage|percentage of SB3 images graded as superior in image quality to SB2|since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|"Primary Endpoint~o Physician's subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2."||||
91742939|NCT00556439|183379984|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.049||||||The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.049
91742940|NCT00556439|183379984|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.853||||||The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.853
91500329|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500330|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91742941|NCT02195700|183380008|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0188|TWO_SIDED|95.0|-2.6|-0.2||5% level of significance (2-sided)|unstructured covariance|||The linear mixed model for repeated measurements (MMRM) included fixed effects for treatment, each scheduled time point (5 levels: weeks 2, 4, 6, 9, and 12), the treatment-by-time point interaction, and the DRA status. Baseline AIMS score was a covariate. The unstructured covariance model was used, and the primary analysis compared the SD-809 and placebo groups at week 12. This was based on the F-test using the Satterhwaite method to compute the denominator degrees of freedom.||-0.2|-2.6|0.0188
91742942|NCT02195700|183380009|SUPERIORITY||Differences in %|7.9||||0.4001|TWO_SIDED|95.0|-10.2|25.2||5% level of significance (2-sided)|Pearson's chi-square test|||The secondary efficacy endpoints were analyzed using a hierarchical testing procedure. If the primary analysis was statistically significant (p\<0.05), then the first key secondary endpoint was to be analyzed. If the first key secondary endpoint was statistically significant, then the second key secondary endpoint was to be similarly analyzed. For any analysis that was not statistically significant, all subsequent analyses of key secondary endpoints were exploratory rather than confirmatory.||25.2|-10.2|0.4001
91742943|NCT01352221|183380022|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
91742944|NCT01352221|183380026|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
91742945|NCT01352221|183380027|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|ANCOVA||||||1.43|< 0.0001
91742946|NCT01352221|183380038|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
91742947|NCT01352221|183380039|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
91742948|NCT01340625|183380053|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.84|||||TWO_SIDED|90.0|100.91|115.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||115.24|100.91|
91742949|NCT01340625|183380054|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.03|||||TWO_SIDED|90.0|96.74|111.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.88|96.74|
91742950|NCT01340625|183380055|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.97|||||TWO_SIDED|90.0|95.73|108.62|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.62|95.73|
91742951|NCT01340625|183380056|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.24|||||TWO_SIDED|90.0|90.04|102.86|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.86|90.04|
91742952|NCT01340625|183380057|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.8|||||TWO_SIDED|90.0|93.89|103.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.97|93.89|
91500331|NCT00174915|182870815|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.479
91742953|NCT01340625|183380058|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.59|||||TWO_SIDED|90.0|94.91|104.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.50|94.91|
91742954|NCT03206970|183380085|OTHER||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<.0001
91742955|NCT03206970|183380089|SUPERIORITY||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<0.0001
91742956|NCT01709110|183380118|SUPERIORITY||Odds Ratio (OR)|0.4071||||9.4e-05|TWO_SIDED|95.0|0.256|0.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.647|0.256|0.000094
91742957|NCT01709110|183380118|SUPERIORITY||Risk Ratio (RR)|0.4431||||9.4e-05|TWO_SIDED|95.0|0.29|0.677|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.677|0.290|0.000094
91742958|NCT01709110|183380119|SUPERIORITY||Odds Ratio (OR)|0.4187||||7.5e-05|TWO_SIDED|95.0|0.269|0.652|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.652|0.269|0.000075
91742959|NCT01709110|183380119|SUPERIORITY||Risk Ratio (RR)|0.4561||||7.5e-05|TWO_SIDED|95.0|0.305|0.682|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.682|0.305|0.000075
91742960|NCT01709110|183380120|SUPERIORITY||Stratified Hazard Ratio (HR)|0.4831||||0.000869|TWO_SIDED|95.0|0.316|0.739|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||0.739|0.316|0.000869
91742961|NCT01709110|183380121|SUPERIORITY||Stratified Hazard Ratio (HR)|0.6553||||0.099023|TWO_SIDED|95.0|0.39|1.101|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.101|0.390|0.099023
91742962|NCT01709110|183380122|SUPERIORITY||Stratified Hazard Ratio (HR)|0.5786||||0.062432|TWO_SIDED|95.0|0.318|1.052|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.052|0.318|0.062432
91742963|NCT01709110|183380123|SUPERIORITY||Odds Ratio (OR)|0.3812|||<|0.001|TWO_SIDED|95.0|0.237|0.614|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.614|0.237|<0.001
91742964|NCT01709110|183380123|SUPERIORITY||Risk Ratio (RR)|0.4173|||<|0.001|TWO_SIDED|95.0|0.27|0.646|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.646|0.270|<0.001
91742965|NCT01709110|183380124|SUPERIORITY||Odds Ratio (OR)|0.1593||||0.007|TWO_SIDED|95.0|0.035|0.728|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.728|0.035|0.007
91742966|NCT01709110|183380124|SUPERIORITY||Risk Ratio (RR)|0.1643||||0.007|TWO_SIDED|95.0|0.036|0.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.744|0.036|0.007
91742967|NCT01709110|183380125|SUPERIORITY||Stratified Hazard Ratio (HR)|0.696||||0.078|TWO_SIDED|95.0|0.461|1.05|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.050|0.461|0.078
91742968|NCT01709110|183380126|SUPERIORITY||Least Squares Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.093|TWO_SIDED|95.0|-0.28|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.28|0.093
91742969|NCT01709110|183380127|SUPERIORITY||Least Squares Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.585|TWO_SIDED|95.0|-0.42|0.24||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain \[0-10\]).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.24|-0.42|0.585
91742970|NCT01709110|183380128|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.757|TWO_SIDED|95.0|-0.03|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.03|0.757
91742971|NCT01709110|183380129|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.694|TWO_SIDED|95.0|-0.02|0.01||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.01|-0.02|0.694
91742972|NCT01951586|183380130|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5157|TWO_SIDED|95.0|0.81|1.53|||Log Rank|Log rank test stratified by the randomization stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.53|0.81|0.5157
91742973|NCT01951586|183380131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3759|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3759
91742974|NCT01951586|183380131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3666|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3666
91742975|NCT01951586|183380131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1917|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1917
91742976|NCT01951586|183380131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3353|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3353
91742977|NCT01951586|183380131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3179|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3179
91742978|NCT01951586|183380131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1583|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1583
91742979|NCT01951586|183380132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3946|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3946
91742980|NCT01951586|183380132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3735|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3735
91742981|NCT01951586|183380133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.3491|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.35|0.43|0.3491
91742982|NCT01951586|183380134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4760
91742983|NCT01951586|183380134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2582|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2582
91531268|NCT03259373|182939137|SUPERIORITY||Standardized Mean Difference (%)|-2.17|STANDARD_ERROR_OF_MEAN|0.009||0.018|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.018
91742984|NCT01951586|183380134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2230
91742985|NCT01951586|183380134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4329|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4329
91742986|NCT01951586|183380134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2620
91742987|NCT01951586|183380134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2081
91742988|NCT01951586|183380135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4671|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4671
91742989|NCT01951586|183380135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4236|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4236
91742990|NCT01951586|183380136|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.46|1.43|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.43|0.46|0.4654
91742991|NCT01951586|183380137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.7363|TWO_SIDED|95.0|0.78|1.43|||Log Rank|Log rank test stratified by the randomized stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.43|0.78|0.7363
91742992|NCT01204905|183380179|OTHER|This was a pilot study with a small sample population. There were no power calculations performed.|||||||||||||||||The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.|||
91742993|NCT01204905|183380180|OTHER|There were no power calculations performed due to the size of the pilot study.|||||||||||||||||Number of weeks to virologic suppression|||
91500332|NCT00174915|182870815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91742994|NCT00104416|183380190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|31.6|||<|0.0001||95.0|15.8|48.1|||Cochran-Mantel-Haenszel|||||48.1|15.8|<0.0001
91742995|NCT02767869|183380220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91742996|NCT02767869|183380221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.530
91742997|NCT02767869|183380222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
91742998|NCT02767869|183380223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
91742999|NCT02767869|183380224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
91743000|NCT02767869|183380225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
91743001|NCT02767869|183380226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
91743002|NCT02767869|183380227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
91743003|NCT02767869|183380228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
91743004|NCT02767869|183380229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.347|||||||Wilcoxon (Mann-Whitney)|||||||0.347
91743005|NCT02767869|183380230|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
91743006|NCT02767869|183380231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.410
91743007|NCT02767869|183380232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91743008|NCT02998671|183380401|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.18|||||TWO_SIDED|90.0|0.79|1.81|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.81|0.79|
91743009|NCT02998671|183380401|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.1|||||TWO_SIDED|90.0|0.66|1.8|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.80|0.66|
91760140|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-7.21|-0.06||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-7.21|
91760141|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-6.25|0.85||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.85|-6.25|
91743010|NCT00595881|183380429|SUPERIORITY_OR_OTHER||Difference in sensitivity|-1.7|||||TWO_SIDED|95.0|-3.4|0.0||"We calculated the differences between the sensitivities and specificities. The difference in sensitivity between the clinical exam alone vs clinical exam + ultrasound was -1.7% (-3.4%, 0%).~The difference in specificity was -2.8% (-9.7%, 4.1%)."|Mixed effects logistic regression|We used the bootstrap method to obtain valid confidence intervals and compare sensitivity and specificity for the 2 tests.|The clinical exam alone was compared to the clinical exam + ultrasound.|See sample size calculations already entered. Null hypothesis is that there is no difference in the sensitivity or specificity of clinical exam alone compared with clinical exam+ultrasound.||0|-3.4|
91743011|NCT00595881|183380429|SUPERIORITY_OR_OTHER||Difference in specificity|-2.8||||||95.0|-9.7|4.1||Statistical significance was defined as a CI surrounding the difference between groups not including 0.||as previously described for sensitivity||as previously described for sensitivity||4.1|-9.7|
91743012|NCT01763333|183380453|SUPERIORITY_OR_OTHER||Slope|0.8728|||||TWO_SIDED|95.0|0.6942|1.0513|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0513|0.6942|
91743013|NCT01763333|183380453|SUPERIORITY_OR_OTHER||Slope|0.9341|||||TWO_SIDED|95.0|0.8277|1.0405|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0405|0.8277|
91743014|NCT01763333|183380453|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|112.74|||||TWO_SIDED|90.0|95.579|132.993|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||132.993|95.579|
91743015|NCT01763333|183380453|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|52.66|||||TWO_SIDED|90.0|40.488|68.499|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||68.499|40.488|
91743016|NCT01763333|183380453|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|239.63|||||TWO_SIDED|90.0|197.445|290.83|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||290.830|197.445|
91743017|NCT01763333|183380453|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|105.47|||||TWO_SIDED|90.0|85.427|130.208|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||130.208|85.427|
91760142|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.63|1.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.60|-5.63|
91531269|NCT03259373|182939137|SUPERIORITY||Standardized Mean Difference (%)|0.05|STANDARD_ERROR_OF_MEAN|0.009||0.956|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.956
91760143|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|95.0|-5.02|2.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-5.02|
91760144|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|||||TWO_SIDED|95.0|-10.07|-2.31||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.31|-10.07|
91743018|NCT01763333|183380455|SUPERIORITY_OR_OTHER||Slope|0.8341|||||TWO_SIDED|95.0|0.6485|1.0198|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0198|0.6485|
91743019|NCT01763333|183380455|SUPERIORITY_OR_OTHER||Slope|0.9149|||||TWO_SIDED|95.0|0.8059|1.0239|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0239|0.8059|
91743020|NCT01763333|183380455|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean Ratio|86.61|||||TWO_SIDED|90.0|76.529|98.029|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.029|76.529|
91743021|NCT01763333|183380455|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|74.44|||||TWO_SIDED|90.0|66.322|83.562|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.562|66.322|
91500333|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500334|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500335|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500336|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500337|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500338|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500339|NCT00174915|182870816|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.011
91500340|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500341|NCT00174915|182870816|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.091
91500342|NCT00174915|182870816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500343|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500344|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91743022|NCT01763333|183380455|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.25|||||TWO_SIDED|90.0|119.708|157.353|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||157.353|119.708|
91743023|NCT01763333|183380455|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.48|||||TWO_SIDED|90.0|111.462|121.724|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||121.724|111.462|
91743024|NCT01763333|183380456|SUPERIORITY_OR_OTHER||Slope|0.8428|||||TWO_SIDED|95.0|0.658|1.0275|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0- tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0275|0.6580|
91743025|NCT01763333|183380456|SUPERIORITY_OR_OTHER||Slope|0.9307|||||TWO_SIDED|95.0|0.8187|1.0426|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.|This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0426|0.8187|
91743026|NCT01763333|183380456|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean Ratio|86.16|||||TWO_SIDED|90.0|75.735|98.027|||||Adjusted geometric mean (gMean) ratio.|Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.027|75.735|
91743027|NCT01763333|183380456|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean ratio|74.42|||||TWO_SIDED|90.0|65.979|83.941|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.941|65.979|
91743028|NCT01763333|183380456|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.2|||||TWO_SIDED|90.0|119.611|157.374|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.||157.374|119.611|
91760145|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-6.6|1.23||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.23|-6.60|
91760146|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-6.64|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|-6.64|
91760147|NCT01393639|183411998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|||||TWO_SIDED|95.0|-6.16|1.58||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.58|-6.16|
91531270|NCT03259373|182939138|SUPERIORITY||Standardized Mean Difference (%)|-1.018|STANDARD_ERROR_OF_MEAN|0.009||0.279|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.279
91500345|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91531271|NCT03259373|182939138|SUPERIORITY||Standardized Mean Difference (%)|-1.347|STANDARD_ERROR_OF_MEAN|0.009||0.143|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.143
91743029|NCT01763333|183380456|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.83|||||TWO_SIDED|90.0|111.814|122.079|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||122.079|111.814|
91743030|NCT03583359|183380459|SUPERIORITY||Difference in Responder Rate|66.8|||<|0.0001|TWO_SIDED|95.0|53.7|75.2|||Fisher's exact test|The Fisher's exact test was utilized to test the superiority of treatment (Radiesse \[+\]) over control group.|Two-sided Newcombe confidence intervals (CIs) were calculated for difference in responder rate.|||75.2|53.7|<0.0001
91743031|NCT01625416|183380465|SUPERIORITY|||||||0.05|||||||Chi-squared|Chi square (2) =5.9, p=0.05|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.05
91743032|NCT01625416|183380466|SUPERIORITY|||||||0.69|||||||Chi-squared|Chi square(2) = 0.74, p = 0.69|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.69
91743033|NCT01625416|183380469|SUPERIORITY|||||||0.97||||||Chi square (2) = 0.06, p = 0.97|Chi-squared||||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.97
91743034|NCT01625416|183380470|SUPERIORITY|||||||0.71|||||||Chi-squared|Chi-Square (2) =0.68, p=0.71|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.71
91743035|NCT00803595|183380532|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|-0.6||||0.748|TWO_SIDED|95.0|-9.9|6.9||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||6.9|-9.9|0.748
91500346|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500347|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91531272|NCT02611830|182939139|SUPERIORITY||Risk Difference (RD)|32.3|||<|0.001|TWO_SIDED|95.0|19.7|45.0||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||45.0|19.7|<0.001
91705332|NCT01153009|183305104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|1.103||0.427|TWO_SIDED|95.0|-3.05|1.29|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.29|-3.05|0.427
91705333|NCT01153009|183305104|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|1.123||0.078|TWO_SIDED|95.0|-4.19|0.22|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.22|-4.19|0.078
91705334|NCT03041467|183305131|SUPERIORITY||||||<|0.001|||||||One-sided Z-test|||||||<0.001
91705335|NCT03041467|183305132|NON_INFERIORITY|Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.||||||0.002|||||||Farrington-Manning Test|||||||0.002
91705336|NCT03041467|183305133|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Log Rank|||Kaplan-Meier method was used to estimate access circuit primary patency.||||<0.001
91500348|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500349|NCT00174915|182870817|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.074
91500350|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500351|NCT00174915|182870817|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.001
91500352|NCT00174915|182870817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
91500353|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500354|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500355|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500356|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500357|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91531273|NCT02611830|182939140|SUPERIORITY||Risk Difference (RD)|35.7|||<|0.001|TWO_SIDED|95.0|22.1|49.3||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||49.3|22.1|<0.001
91531274|NCT02611830|182939141|SUPERIORITY||Risk Difference (RD)|36.1|||<|0.001|TWO_SIDED|95.0|21.2|50.9||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||50.9|21.2|<0.001
91500358|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500359|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91743036|NCT00803595|183380532|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.8||||0.038|TWO_SIDED|95.0|-18.2|-0.4||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||Null hypothesis was that there was no difference in the time to illness alleviation||-0.4|-18.2|0.038
91500360|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91531275|NCT02611830|182939142|SUPERIORITY||Risk Difference (RD)|9.7||||0.076|TWO_SIDED|95.0|-6.6|25.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||25.7|-6.6|0.076
91531276|NCT02611830|182939143|SUPERIORITY||Risk Difference (RD)|20.6||||0.067|TWO_SIDED|95.0|-4.5|43.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||43.7|-4.5|0.067
91531277|NCT01607411|182939151|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.59|||<|0.0001|TWO_SIDED|95.0|3.6|7.58||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||7.58|3.60|<0.0001
91759518|NCT02391363|183411769|SUPERIORITY|||||||0.98||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.98
91500361|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91743037|NCT00803595|183380532|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|12.2||||0.104|TWO_SIDED|95.0|-1.5|17.2|||Generalized Wilcoxon test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||17.2|-1.5|0.104
91743038|NCT00803595|183380533|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.3||||0.318|TWO_SIDED|95.0|-2.8|9.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||9.1|-2.8|0.318
91743039|NCT00803595|183380533|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.981|TWO_SIDED|95.0|-5.8|5.7||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||5.7|-5.8|0.981
91743040|NCT00803595|183380533|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.7||||0.344|TWO_SIDED|95.0|-9.1|3.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||3.1|-9.1|0.344
91500362|NCT00174915|182870818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91743041|NCT01597908|183380537|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.58|0.83|||||Hazard ratios are estimated using a Pike estimator.|||0.83|0.58|
91743042|NCT01597908|183380538|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.52|0.73|||||Hazard ratios are estimated using a Pike estimator.|||0.73|0.52|
91743043|NCT01597908|183380540|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.51|0.81||||||||0.81|0.51|
91743044|NCT03522246|183380597|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.47||||0.0004|TWO_SIDED|95.0|0.31|0.72|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification and timing of surgery.|||0.72|0.31|0.0004
91743045|NCT03522246|183380598|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||0.68|0.40|<0.0001
91743046|NCT03522246|183380599|SUPERIORITY|Rucaparib + Nivolumab vs Rucaparib + Placebo|Hazard Ratio (HR)|1.29||||0.0038|TWO_SIDED|95.0|1.08|1.53|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||1.53|1.08|0.0038
91743047|NCT00814580|183380612|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (\< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.|Least square mean difference|9.0|STANDARD_ERROR_OF_MEAN|14.2||0.5265|TWO_SIDED|95.0|-18.9|36.9||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||Tapentadol IR versus Oxycodone IR||36.9|-18.9|0.5265
91743048|NCT00814580|183380613|SUPERIORITY_OR_OTHER|||||||0.7306||95.0|||||Log Rank|||||||0.7306
91743049|NCT00814580|183380614|SUPERIORITY_OR_OTHER|||||||0.8524||95.0|||||Log Rank|||||||0.8524
91743050|NCT00814580|183380615|SUPERIORITY_OR_OTHER|||||||0.9078||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.9078
91743051|NCT00814580|183380616|SUPERIORITY_OR_OTHER|||||||0.2633||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2633
91743052|NCT00814580|183380617|SUPERIORITY_OR_OTHER|||||||0.4498||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.4498
91500363|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91743053|NCT00814580|183380618|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2158
91743054|NCT00814580|183380619|SUPERIORITY_OR_OTHER||Least square mean difference|6.6|STANDARD_ERROR_OF_MEAN|9.34||0.4811|TWO_SIDED|95.0|-11.8|25.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||25.0|-11.8|0.4811
91743055|NCT00814580|183380620|SUPERIORITY_OR_OTHER||Least square mean difference|-9.3|STANDARD_ERROR_OF_MEAN|28.13||0.7405|TWO_SIDED|95.0|-64.7|46.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||46.0|-64.7|0.7405
91500364|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500365|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500366|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500367|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500368|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91743056|NCT00814580|183380621|SUPERIORITY_OR_OTHER||Least square mean difference|-5.6|STANDARD_ERROR_OF_MEAN|5.53||0.3097|TWO_SIDED|95.0|-16.5|5.3||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.3|-16.5|0.3097
91500369|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500370|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500371|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91743057|NCT00814580|183380622|SUPERIORITY_OR_OTHER||Least square mean difference|-10.3|STANDARD_ERROR_OF_MEAN|8.34||0.2179|TWO_SIDED|95.0|-26.7|6.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||6.1|-26.7|0.2179
91743058|NCT00814580|183380623|SUPERIORITY_OR_OTHER||Least square mean difference|-26.3|STANDARD_ERROR_OF_MEAN|16.16||0.1051|TWO_SIDED|95.0|-58.1|5.5||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.5|-58.1|0.1051
91500372|NCT00174915|182870819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
91500373|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.789
91500374|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
91531278|NCT01607411|182939151|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.36|||<|0.0001|TWO_SIDED|95.0|2.37|6.35||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||6.35|2.37|<0.0001
91743059|NCT00814580|183380624|SUPERIORITY_OR_OTHER||Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|12.09||0.9367|TWO_SIDED|95.0|-22.8|24.8||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||24.8|-22.8|0.9367
91743060|NCT00814580|183380625|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|18.53||0.9441|TWO_SIDED|95.0|-37.8|35.2||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||35.2|-37.8|0.9441
91500375|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.381
91500376|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.809
91500377|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.154
91500378|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.247
91500379|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.415
91743061|NCT00814580|183380626|SUPERIORITY_OR_OTHER||Least square mean difference|-35.6|STANDARD_ERROR_OF_MEAN|37.45||0.3427|TWO_SIDED|95.0|-109.3|38.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||38.1|-109.3|0.3427
91743062|NCT00814580|183380627|SUPERIORITY_OR_OTHER|||||||0.1618||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.1618
91743063|NCT00814580|183380628|SUPERIORITY_OR_OTHER|||||||0.0481||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.0481
91743064|NCT00814580|183380629|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers|Cochran-Mantel-Haenszel|||||||0.0109
91500380|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.649
91743065|NCT02482428|183380646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.07||0.862|TWO_SIDED|90.0|-0.03|0.2|||Posterior mean|||||0.20|-0.03|0.862
91743066|NCT02482428|183380646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.07||0.541|TWO_SIDED|90.0|-0.07|0.19|||posterior mean|||||0.19|-0.07|0.541
91743067|NCT01519791|183380696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.283|||<|0.001|TWO_SIDED|95.0|1.503|3.468|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||3.468|1.503|<0.001
91743068|NCT01519791|183380697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957|||<|0.001|TWO_SIDED|95.0|1.384|2.767|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||2.767|1.384|<0.001
91743069|NCT01519791|183380698|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate of shift|-0.978|||<|0.001|TWO_SIDED|95.0|-1.005|-0.5|||ANCOVA on ranks||"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or \>4 months) as factors and rank Baseline value as a covariate.~Confidence Interval is an asymptotic Moses CI."|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.500|-1.005|<0.001
91743070|NCT01519791|183380703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446|||=|0.023|TWO_SIDED|95.0|1.052|1.989|||Regression, Logistic||The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||1.989|1.052|=0.023
91743071|NCT01519791|183380715|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-0.177|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.273|-0.082|||ANCOVA||The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or \>4 months) as factors and Baseline value as a covariate.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.082|-0.273|<0.001
91743072|NCT01525862|183380737|SUPERIORITY||||||<|0.0001||||||P values \<0.05 are considered statistically significant.|t-test, 2 sided|||||||<0.0001
91743073|NCT00241176|183380741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)||YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).|Group 1 Baseline vs. Endpoint||||<.05
91743074|NCT00241176|183380742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)||Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).|Mean scores baseline to endpoint||||<.05
91743075|NCT01129765|183380743|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Proportion responding \>=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.||1.0|0.83|
91500381|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.807
91500382|NCT00174915|182870820|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.844
91500383|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.699
91500384|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.822
91705337|NCT03041467|183305134|OTHER|There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months. Survival analysis was performed using Kaplan-Meier method.|Log Rank|||Kaplan-Meier method was used to estimate target lesion primary patency.|Survival analysis was performed using Kaplan-Meier method.|||<0.001
91500385|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.579
91500386|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.679
91500387|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.278
91500388|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.104
91500389|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.560
91500390|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.309||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.309
91531279|NCT01607411|182939151|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.16||||0.0021|TWO_SIDED|95.0|1.17|5.15||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||5.15|1.17|0.0021
91743076|NCT01129765|183380744|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.83|
91743077|NCT01129765|183380745|SUPERIORITY_OR_OTHER||Proportion|0.97||||0.0005|TWO_SIDED|95.0|0.83|1.0|||One-sample proportion|||"Null hypothesis: Pr ≤ 0.7 versus HA: Pr \> 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%."||1.0|0.83|0.0005
91743078|NCT01129765|183380746|SUPERIORITY_OR_OTHER||Proportion|1.0|||||TWO_SIDED|95.0|0.88|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.88|
91743079|NCT01129765|183380747|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
91743080|NCT01129765|183380748|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
91500391|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.759
91500392|NCT00174915|182870821|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.385
91500393|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.949
91500394|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.050
91500395|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.577
91500396|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.598||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.598
91500397|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.062
91500398|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.969
91500399|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.056
91500400|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.659
91500401|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.197
91500402|NCT00174915|182870822|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.521
91500403|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.683
91500404|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.078
91500405|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.442
91500406|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.990
91500407|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.077
91743081|NCT03645421|183380753|OTHER||Least squares (LS) mean difference|-42.11|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-50.47|-33.75|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-33.75|-50.47|<0.0001
91743082|NCT03645421|183380753|OTHER||LS mean difference|-33.61|STANDARD_ERROR_OF_MEAN|4.69|<|0.0001|TWO_SIDED|95.0|-43.04|-24.18|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-24.18|-43.04|<0.0001
91743083|NCT03645421|183380753|OTHER||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|4.57|<|0.0001|TWO_SIDED|95.0|-49.49|-31.12|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-31.12|-49.49|<0.0001
91743084|NCT03645421|183380754|OTHER||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.89||0.1476|TWO_SIDED|95.0|-3.08|0.47|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||0.47|-3.08|0.1476
91743085|NCT03645421|183380754|OTHER||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.92||0.008|TWO_SIDED|95.0|-4.37|-0.69|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.69|-4.37|0.0080
91743086|NCT03645421|183380754|OTHER||LS mean difference|-2.52|STANDARD_ERROR_OF_MEAN|0.89||0.0063|TWO_SIDED|95.0|-4.3|-0.74|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.74|-4.30|0.0063
91743087|NCT03645421|183380757|OTHER||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.48|-0.7|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.70|-1.48|<0.0001
91743088|NCT03645421|183380757|OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.49|-0.71|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.71|-1.49|<0.0001
91743089|NCT03645421|183380757|OTHER||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.38|-1.15|0.0002
91743090|NCT03645421|183380758|OTHER||LS mean difference|-56.69|STANDARD_ERROR_OF_MEAN|8.75|<|0.0001|TWO_SIDED|95.0|-74.3|-39.09|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-39.09|-74.30|<0.0001
91743091|NCT03645421|183380758|OTHER||LS mean difference|-60.58|STANDARD_ERROR_OF_MEAN|9.92|<|0.0001|TWO_SIDED|95.0|-80.53|-40.63|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-40.63|-80.53|<0.0001
91743092|NCT03645421|183380758|OTHER||LS mean difference|-55.07|STANDARD_ERROR_OF_MEAN|9.55|<|0.0001|TWO_SIDED|95.0|-74.28|-35.86|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-35.86|-74.28|<0.0001
91743093|NCT03645421|183380759|OTHER||LS mean difference|-0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.094|-0.047|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.047|-0.094|<0.0001
91743094|NCT03645421|183380759|OTHER||LS mean difference|-0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.077|-0.03|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.030|-0.077|<0.0001
91743095|NCT03645421|183380759|OTHER||LS mean difference|-0.049|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.074|-0.024|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.024|-0.074|0.0002
91500408|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.662
91500409|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.139
91500410|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.705
91743096|NCT03636893|183380800|OTHER|Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.06||||0.842|TWO_SIDED|95.0|0.597|1.884||P-value from two-sided log-rank test. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Disease-free survival analysis in intention-to-treat population. DFS defined as time from randomization to first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.|Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios.|1.884|0.597|0.842
91743097|NCT03636893|183380801|OTHER|Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.101||||0.759|TWO_SIDED|95.0|0.595|2.036||P-value from two-sided log-rank test. No adjustment for multiple comparisons as overall survival was a pre-specified secondary endpoint. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Primary survival analysis comparing overall survival between neoadjuvant FLOT and SOX regimens in intention-to-treat population.|Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors.|2.036|0.595|0.759
91500411|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.337
91500412|NCT00174915|182870823|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.643
91500413|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.645
91743098|NCT00758069|183380815|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-25.9|||<|0.001||95.0|-34.2|-17.5||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-17.5|-34.2|<0.001
91743099|NCT00758069|183380815|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.5|||<|0.001||95.0|-28.0|-11.1||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.1|-28.0|<0.001
91743100|NCT00758069|183380816|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.3|||<|0.001||95.0|-26.6|-11.9||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.9|-26.6|<0.001
91743101|NCT00758069|183380816|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-12.9|||<|0.001||95.0|-20.4|-5.4||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-5.4|-20.4|<0.001
91743102|NCT02277691|183380845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 12 (LOCF).||||<0.0001
91743103|NCT02277691|183380845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 52 (LOCF).||||<0.0001
91743104|NCT02277691|183380845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 12 (LOCF).||||<0.0001
91743105|NCT02277691|183380845|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 52 (LOCF).||||<0.0001
91743106|NCT02277691|183380846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at End of Week 12.||||<0.0001
91743107|NCT02277691|183380846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at EOT (Up to Week 52).||||<0.0001
91743108|NCT02277691|183380846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at End of Week 12.||||<0.0001
91743109|NCT02277691|183380846|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at EOT (Up to Week 52).||||<0.0001
91743110|NCT04343534|183380854|OTHER||Mean Difference (Final Values)|0.15||||0.092|TWO_SIDED|95.0|-0.02|0.33|||t-test, 2 sided|||"SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.~we conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions."||0.33|-0.02|0.092
91743111|NCT01804049|183380863|SUPERIORITY|Hypothesis: metformin will reduce loss of total lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.45||||||For lean total body mass, t(118)=0.744, p=0.45.|t-test, 2 sided|T-test calculation for total lean mass: 0.74.||||||0.45
91743112|NCT01804049|183380863|SUPERIORITY|Hypothesis: metformin will reduce loss of total appendicular lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.79||||||For lean appendicular body mass, t(118) = 0.264, p=0.79.|t-test, 2 sided|T-test calculation appendicular lean mass: 0.26.||||||0.79
91743113|NCT01804049|183380864|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|t(118)=0.703, p=0.48||||||0.48
91743114|NCT03985943|183380866|OTHER||Strata-adjusted percentage difference|11.5||||0.0003|TWO_SIDED|97.5|4.7|18.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.3|4.7|0.0003
91743115|NCT03985943|183380867|OTHER||Strata-adjusted percentage difference|14.3||||0.0002|TWO_SIDED|97.5|6.1|22.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.5|6.1|0.0002
91760148|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-0.83|4.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.83|
91500414|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.756
91705338|NCT03041467|183305135|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Chi-squared|||||||<0.001
91705339|NCT03041467|183305139|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
91705340|NCT03041467|183305140|SUPERIORITY|||||||0.482|||||||Chi-squared|||||||0.482
91705341|NCT03041467|183305141|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
91705342|NCT02330172|183305154|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91705343|NCT02330172|183305155|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91705344|NCT00135356|183305201|SUPERIORITY_OR_OTHER||Difference in Means|0.03||||0.48||95.0|-0.06|0.12||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||LOCF||0.12|-0.06|0.48
91705345|NCT00135356|183305201|SUPERIORITY_OR_OTHER||Difference in Means|0.07||||0.57||95.0|-0.07|12.0||P-value not adjusted for multiple testing. 2-sided 95% CI|t-test, 2 sided|||OC||12.0|-0.07|0.57
91705346|NCT00135356|183305202|SUPERIORITY_OR_OTHER||Difference in Means|0.02||||0.73||95.0|-0.1|0.14||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||LOCF||0.14|-0.10|0.73
91705347|NCT00135356|183305202|SUPERIORITY_OR_OTHER||Difference in Means|-0.01||||0.91||95.0|-0.14|0.13||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||OC||0.13|-0.14|0.91
91705348|NCT00135356|183305203|SUPERIORITY_OR_OTHER||Difference in Mean|5.2||||0.27||95.0|-3.9|15.1||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 VAT LOCF||15.1|-3.9|0.27
91705349|NCT00135356|183305203|SUPERIORITY_OR_OTHER||Difference in Mean|1.8||||0.68||95.0|-6.7|11.2||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||VAT, Week 96 LOCF||11.2|-6.7|0.68
91705350|NCT00135356|183305203|SUPERIORITY_OR_OTHER||Difference in Means|4.4||||0.14||95.0|-1.4|10.6||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Trunk Fat LOCF||10.6|-1.4|0.14
91705351|NCT00135356|183305203|SUPERIORITY_OR_OTHER||Difference in Means|5.3||||0.14||95.0|-1.7|12.9||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Trunk Fat LOCF||12.9|-1.7|0.14
91705352|NCT00135356|183305204|SUPERIORITY_OR_OTHER||Difference in Means|4.0||||0.16||95.0|-1.6|10.0||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||SAT, Week 48, LOCF||10.0|-1.6|0.16
91705353|NCT00135356|183305204|SUPERIORITY_OR_OTHER||Difference in Mean|6.8||||0.06||95.0|-0.2|14.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 SAT||14.2|-0.2|0.06
91705354|NCT00135356|183305204|SUPERIORITY_OR_OTHER||Difference in Means|4.6||||0.15||95.0|-1.7|11.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48, Limb Fat||11.4|-1.7|0.15
91705355|NCT00135356|183305204|SUPERIORITY_OR_OTHER||Difference in Means|5.7||||0.17||95.0|-2.3|14.4||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||Week 96, Limb Fat||14.4|-2.3|0.17
91705356|NCT00135356|183305205|SUPERIORITY_OR_OTHER||DIfference in Means|3.6||||0.19||95.0|-1.8|9.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 TAT||9.4|-1.8|0.19
91705357|NCT00135356|183305205|SUPERIORITY_OR_OTHER||DIfference in Means|4.3||||0.16||95.0|-1.7|10.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|Wilcoxon (Mann-Whitney)|||Week 96 TAT||10.7|-1.7|0.16
91705358|NCT00135356|183305205|SUPERIORITY_OR_OTHER||Difference in Means|5.0||||0.0385||95.0|0.3|9.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Total Body Fat||9.7|0.3|0.0385
91705359|NCT00135356|183305205|SUPERIORITY_OR_OTHER||Difference in Means|5.9||||0.1||95.0|-1.0|13.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Total Body Fat||13.2|-1.0|0.10
91705360|NCT00135356|183305217|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.3|3.72||||||||3.72|0.3|
91705361|NCT01306214|183305227|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.61|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 10 mg - Adjusted mean of placebo.|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~Hypothesis test:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.27|-0.61|<0.0001
91705362|NCT01306214|183305227|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.69|-0.35||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.35|-0.69|<0.0001
91705363|NCT01306214|183305228|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.83|STANDARD_ERROR_OF_MEAN|3.05||0.004|TWO_SIDED|97.5|-15.69|-1.97||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo"||-1.97|-15.69|0.004
91500415|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.428
91500416|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons..|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL)||||||0.076
91743116|NCT03985943|183380868|OTHER||Strata-adjusted percentage difference|14.9|||<|0.0001|TWO_SIDED|97.5|7.8|22.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.0|7.8|<0.0001
91743117|NCT03985943|183380869|OTHER||Strata-adjusted percentage difference|18.1|||<|0.0001|TWO_SIDED|97.5|9.6|26.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.6|9.6|<0.0001
91743118|NCT03985943|183380870|OTHER||Strata-adjusted percentage difference|24.9|||<|0.0001|TWO_SIDED|97.5|18.4|31.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||31.5|18.4|<0.0001
91743119|NCT03985943|183380870|OTHER||Strata-adjusted percentage difference|28.1|||<|0.0001|TWO_SIDED|97.5|22.0|34.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.3|22.0|<0.0001
91743120|NCT03985943|183380871|OTHER||Strata-adjusted percentage difference|27.5|||<|0.0001|TWO_SIDED|97.5|19.4|35.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||35.7|19.4|<0.0001
91743121|NCT03985943|183380871|OTHER||Strata-adjusted percentage difference|32.1|||<|0.0001|TWO_SIDED|97.5|24.4|39.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||39.8|24.4|<0.0001
91743122|NCT03985943|183380872|OTHER||Strata-adjusted percentage difference|19.5|||<|0.0001|TWO_SIDED|97.5|13.7|25.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.2|13.7|<0.0001
91743123|NCT03985943|183380873|OTHER||Strata-adjusted percentage difference|20.3|||<|0.0001|TWO_SIDED|97.5|13.8|26.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.8|13.8|<0.0001
91743124|NCT03985943|183380874|OTHER||Strata-adjusted percentage difference|17.9|||<|0.0001|TWO_SIDED|97.5|11.3|24.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.5|11.3|<0.0001
91743125|NCT03985943|183380875|OTHER||Strata-adjusted percentage difference|19.7|||<|0.0001|TWO_SIDED|97.5|11.2|28.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||28.2|11.2|<0.0001
91743126|NCT03985943|183380876|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.8|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26|15.8|<0.0001
91531280|NCT01607411|182939152|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.23||||0.2225|TWO_SIDED|95.0|-0.76|3.22||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.22|-0.76|0.2225
91743127|NCT03985943|183380877|OTHER||Strata-adjusted percentage difference|21.2|||<|0.0001|TWO_SIDED|97.5|14.8|27.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||27.6|14.8|<0.0001
91743128|NCT03985943|183380878|OTHER||Strata-adjusted percentage difference|12.2|||<|0.0001|TWO_SIDED|97.5|8.2|16.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||16.3|8.2|<0.0001
91743129|NCT03985943|183380879|OTHER||Strata-adjusted percentage difference|9.7|||<|0.0001|TWO_SIDED|97.5|5.2|14.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.2|5.2|<0.0001
91743130|NCT03985943|183380880|OTHER||Strata-adjusted percentage difference|14.6|||<|0.0001|TWO_SIDED|97.5|10.6|18.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.7|10.6|<0.0001
91743131|NCT03985943|183380881|OTHER||Strata-adjusted percentage difference|16.9|||<|0.0001|TWO_SIDED|97.5|11.5|22.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.3|11.5|<0.0001
91743132|NCT03985943|183380882|OTHER||Strata-adjusted percentage difference|3.4||||0.0064|TWO_SIDED|97.5|1.1|5.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||5.8|1.1|0.0064
91743133|NCT03985943|183380883|OTHER||Strata-adjusted percentage difference|4.3||||0.0177|TWO_SIDED|97.5|0.9|7.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||7.7|0.9|0.0177
91743134|NCT04075513|183380885|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was \> 0.|Least square mean difference|3.16|STANDARD_ERROR_OF_MEAN|1.163||0.0067|TWO_SIDED|95.0|0.88|5.44||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 90% of Tresiba LS mean.|Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||5.44|0.88|0.0067
91743135|NCT04075513|183380886|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since lower CV means better outcome, non-inferiority was demonstrated if the upper bound of the two-sided 95% CI of the difference between Toujeo LS mean and 110% of Tresiba LS mean at Week 12 was \< 0.|Least square mean difference|-5.44|STANDARD_ERROR_OF_MEAN|0.542|<|0.0001|TWO_SIDED|95.0|-6.5|-4.38||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 110% of Tresiba LS mean.|A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||-4.38|-6.50|<0.0001
91743136|NCT04075513|183380887|SUPERIORITY|Superiority was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate of Toujeo and Tresiba at Week 12 was \>0.|Least square mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.225||0.0548|TWO_SIDED|95.0|-4.75|0.05||Threshold of significance at \<0.05.|ANCOVA|||A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||0.05|-4.75|0.0548
91531281|NCT01607411|182939152|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.44||||0.0168|TWO_SIDED|95.0|0.44|4.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||4.43|0.44|0.0168
91743137|NCT03629223|183380900|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%. In the below, LS-means = least squares mean.|Percentage of Ratio of Geometric LS-Mean|115.35|||||TWO_SIDED|90.0|108.55|122.58||||||||122.58|108.55|
91743138|NCT03629223|183380900|OTHER||Percentage of ratio of Geometric LS-Mean|186.37|||||TWO_SIDED|90.0|163.61|212.28||||||||212.28|163.61|
91743139|NCT03629223|183380900|OTHER||Percentage of ratio of Geometric LS-Mean|163.15|||||TWO_SIDED|90.0|146.17|182.1||||||||182.10|146.17|
91743140|NCT03629223|183380901|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|115.34|||||TWO_SIDED|90.0|108.51|122.6||||||||122.60|108.51|
91743141|NCT03629223|183380901|OTHER||Percentage of ratio of Geometric LS-Mean|186.67|||||TWO_SIDED|90.0|163.78|212.77||||||||212.77|163.78|
91743142|NCT03629223|183380901|OTHER||Percentage of ratio of Geometric LS-Mean|163.26|||||TWO_SIDED|90.0|146.09|182.46||||||||182.46|146.09|
91743143|NCT03629223|183380902|EQUIVALENCE|Analysis was performed with equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|113.57|||||TWO_SIDED|90.0|107.62|119.85||||||||119.85|107.62|
91743144|NCT03629223|183380902|OTHER||Percentage of ratio of Geometric LS-Mean|236.51|||||TWO_SIDED|90.0|215.69|259.34||||||||259.34|215.69|
91743145|NCT03629223|183380902|OTHER||Percentage of ratio of Geometric LS-Mean|199.61|||||TWO_SIDED|90.0|176.44|225.82||||||||225.82|176.44|
91743146|NCT00617097|183380941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.94|TWO_SIDED|95.0|-13.7|12.6|||Regression, Linear|||expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||12.6|-13.7|0.94
91743147|NCT00617097|183380941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.9|TWO_SIDED|95.0|-15.1|13.2|||Regression, Linear|||after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||13.2|-15.1|0.9
91743148|NCT00617097|183380941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.49|TWO_SIDED|95.0|-18.6|9.0|||Regression, Linear|||during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||9|-18.6|0.49
91743149|NCT00617097|183380941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0||||0.03|TWO_SIDED|95.0|-28.3|-1.7|||Regression, Linear|||after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||-1.7|-28.3|0.03
91743150|NCT00617097|183380941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7|TWO_SIDED|95.0|-12.2|18.0|||Regression, Linear|||immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||18|-12.2|0.7
91743151|NCT00617097|183380941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.52|TWO_SIDED|95.0|-17.0|8.8|||Regression, Linear|||30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||8.8|-17|.52
91743152|NCT00617097|183380942|SUPERIORITY_OR_OTHER|||||||0.93|||||||Regression, Linear|||greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)||||0.93
91743153|NCT00617097|183380943|SUPERIORITY_OR_OTHER|||||||0.07|||||||Chi-squared|||greater number is worse (i.e., more symptoms)||||0.07
91743154|NCT00617097|183380944|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||minor complications greater number is worse (i.e., more complications)||||1
91743155|NCT00617097|183380944|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||serious complications||||0.15
91743156|NCT01576939|183380981|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.9906|TWO_SIDED|95.0|0.979|1.022|||Regression, Cox|This was a Cox proportional hazards model with dose as the single predictor.||||1.022|0.979|0.9906
91743157|NCT01576939|183380982|SUPERIORITY_OR_OTHER||Slope|0.2795||||0.1209|TWO_SIDED|95.0|-0.077|0.634|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||0.634|-0.077|0.1209
91743158|NCT01576939|183380983|SUPERIORITY_OR_OTHER||Slope|-0.285||||0.9832|TWO_SIDED|95.0|-27.28|26.71|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||26.71|-27.28|0.9832
91743159|NCT01576939|183380984|SUPERIORITY_OR_OTHER||Slope|0.03795||||0.0263|TWO_SIDED|95.0|0.00483|0.071|||Mixed Models Analysis|A repeated measures model with dose as the single predictor. QoL values were measured for each patient every week.||||0.071|0.00483|0.0263
91743160|NCT01576939|183380985|SUPERIORITY_OR_OTHER||Slope|0.0567||||0.0039|TWO_SIDED|95.0|0.0199|0.0935|||Mixed Models Analysis|A repeated measures model with dose as the single predictor and QoL values measured each week for each patient.||||0.0935|0.0199|0.0039
91743161|NCT00434993|183381012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.087|TWO_SIDED|95.0|-4.7|0.3||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.||0.3|-4.7|0.087
91743162|NCT00434993|183381013|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3||||0.302|TWO_SIDED|95.0|-4.0|14.7||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||14.7|-4.0|0.302
91743163|NCT00434993|183381014|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.9||||0.261|TWO_SIDED|95.0|-3.7|15.4||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||15.4|-3.7|0.261
91743164|NCT00434993|183381015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.023|TWO_SIDED|95.0|-4.9|-0.4||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||-0.4|-4.9|0.023
91500417|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.106
91500418|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.069
91531282|NCT01607411|182939152|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.2||||0.2352|TWO_SIDED|95.0|-0.79|3.19||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.19|-0.79|0.2352
91531283|NCT01607411|182939153|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|34.65|||<|0.0001|TWO_SIDED|95.0|30.07|39.24||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.24|30.07|<0.0001
91743165|NCT00434993|183381016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.226|TWO_SIDED|95.0|-4.3|0.9||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||0.9|-4.3|0.226
91743166|NCT00434993|183381017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.13|TWO_SIDED|95.0|-5.3|0.6|||ANCOVA|Adjusted for baseline shock.||||0.6|-5.3|0.130
91743167|NCT00434993|183381018|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.2||||0.176|TWO_SIDED|95.0|-3.1|19.6|||Regression, Logistic|Adjusted for baseline shock.||||19.6|-3.1|0.176
91743168|NCT00434993|183381019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.048|TWO_SIDED|95.0|-7.8|0.0|||ANCOVA|||||-0.0|-7.8|0.048
91743169|NCT00434993|183381020|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5||||0.265|TWO_SIDED|95.0|-6.9|25.9|||Regression, Logistic|||||25.9|-6.9|0.265
91743170|NCT03335150|183381022|OTHER|Equality|Mean Difference (Final Values)|0.4856||||0.6662|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = Standard Error (SE) of the interaction term.|||||0.6662
91500419|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.837
91500420|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.749
91743171|NCT03335150|183381022|OTHER|Equality|Mean Difference (Final Values)|0.2415||||0.1617|TWO_SIDED||||||Mixed Models Analysis|Mean Matrix Reasoning Total (MRT) difference between two visits while controlling for intervention.|estimated value = SE|||||0.1617
91743172|NCT03335150|183381022|OTHER|Equality|Mean Difference (Final Values)|0.5087||||0.6236|TWO_SIDED||||||Mixed Models Analysis|Mean MRT difference between two interventions while controlling for visit.|estimated value = SE|||||0.6236
91500421|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.581
91743173|NCT03335150|183381023|OTHER|Equality|Mean Difference (Final Values)|0.58||||0.0496|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated value = SE of interaction term|||||0.0496
91743174|NCT03335150|183381024|OTHER|Equality|Mean Difference (Final Values)|1.62||||0.047|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.047
91743175|NCT03335150|183381025|OTHER|Equality|Mean Difference (Final Values)|2.97||||0.001|TWO_SIDED|||||Interaction Term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.001
91743176|NCT03335150|183381026|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.02|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.020
91743177|NCT03335150|183381027|OTHER|Equality|Mean Difference (Final Values)|1.26||||0.444|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.444
91743178|NCT03335150|183381027|OTHER|Equality|Mean Difference (Final Values)|1.145||||0.0233|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between intervention groups controlling for visit and other significant covariates.|estimated value = SE|||||0.0233
91743179|NCT03335150|183381027|OTHER|Equality|Mean Difference (Final Values)|0.6281|||<|0|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates|estimated value = SE|||||<0.000
91743180|NCT03335150|183381028|OTHER|Equality|Mean Difference (Final Values)|2.205||||0.073|TWO_SIDED|||||Interaction term|Mixed Models Analysis||estimated value = SE of interaction term|||||0.073
91743181|NCT03335150|183381029|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.82|TWO_SIDED|||||Interaction Term|Mixed Models Analysis|||||||0.82
91743182|NCT03335150|183381029|OTHER|Equality|Mean Difference (Final Values)|1.1172||||0.0257|TWO_SIDED||||||Mixed Models Analysis|Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates.|estimated value = SE|||||0.0257
91500422|NCT00174915|182870824|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.311
91743183|NCT03335150|183381029|OTHER|Equality|Mean Difference (Final Values)|3.8649||||0.1101|TWO_SIDED||||||Mixed Models Analysis|Difference in PDQ-39 between two interventions controlling for visit and covariates.|estimated value = SE|||||0.1101
91743184|NCT03335150|183381030|OTHER|Equality|Median Difference (Final Values)|1.784||||0.0263|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of the interaction term.|||||0.0263
91743185|NCT02218697|183381046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.13|||||TWO_SIDED|95.0|0.88|1.46|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.46|0.88|
91743186|NCT02218697|183381046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.97|||||TWO_SIDED|95.0|0.78|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.21|0.78|
91743187|NCT02218697|183381046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.98|1.4|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.40|0.98|
91743188|NCT02218697|183381046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.84|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.16|0.84|
91743189|NCT02218697|183381047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.86|1.5|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.50|0.86|
91500423|NCT03060447|182870826|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 2||||0.55
91500424|NCT03060447|182870826|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 8||||0.54
91743190|NCT02218697|183381047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.18|||||TWO_SIDED|95.0|0.96|1.45|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.45|0.96|
91743191|NCT02218697|183381047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.26|||||TWO_SIDED|95.0|0.98|1.62|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.62|0.98|
91760149|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.35|5.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.45|0.35|
91500425|NCT03060447|182870826|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 1||||0.54
91500426|NCT03060447|182870826|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 8||||0.54
91743192|NCT02218697|183381047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|0.95|1.63|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.63|0.95|
91500427|NCT03060447|182870826|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 1||||0.54
91743193|NCT02218697|183381047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|0.91|1.57|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.57|0.91|
91743194|NCT02218697|183381047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.34|||||TWO_SIDED|95.0|1.05|1.7|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.70|1.05|
91743195|NCT04776720|183381096|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
91743196|NCT04776720|183381097|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
91743197|NCT04776720|183381098|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with variance co-variance matrix||||5.84|-3.87|0.689
91743198|NCT04776720|183381099|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
91743199|NCT04776720|183381100|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
91743200|NCT04776720|183381101|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
91500428|NCT03060447|182870826|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 8||||0.57
91743201|NCT04776720|183381102|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
91743202|NCT04776720|183381103|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|Adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
91743203|NCT04776720|183381104|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
91743204|NCT04776720|183381105|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
91743205|NCT02311881|183381106|SUPERIORITY_OR_OTHER||LS mean difference|-2.51||||0.1626|TWO_SIDED|95.0|-6.037|1.016|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo."||1.016|-6.037|0.1626
91743206|NCT02311881|183381106|NON_INFERIORITY_OR_EQUIVALENCE|Paracetamol 2000mg BID is non-inferior to Paracetamol 1330mg TID if the upper bound of the 95% confidence Interval is less than 5.3.|LS mean difference|-2.36|||||TWO_SIDED|95.0|-5.894|1.166|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is ≤ - 5.3 (inferiority).~H1: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is \> - 5.3 (noninferiority)."||1.166|-5.894|
91743207|NCT02311881|183381106|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.9352|TWO_SIDED|95.0|-3.687|3.394|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo."||3.394|-3.687|0.9352
91500429|NCT03060447|182870826|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 1||||0.54
91500430|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 2||||0.52
91500431|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 4||||0.52
91500432|NCT03060447|182870826|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 8||||0.61
91500433|NCT03060447|182870826|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 1||||0.54
91500434|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 8||||0.52
91500435|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 1||||0.52
91500436|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 6: Day 4||||0.52
91500437|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 8||||0.52
91500438|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7: Day 1||||0.52
91743208|NCT03306433|183381116|EQUIVALENCE|The null hypothesis is that there are no significant paired differences between the groups. The power calculation is based on the observed variation and number of participants|Paired difference t-test|-12.139|STANDARD_DEVIATION|7.101||0.0003|TWO_SIDED|||||Paired difference p value comparing UDMA-K18 vs Adhesive Control|Paired difference test, 2 sided||There are 12 participants (pairs) for this comparison|Paired difference test within each participant.||||0.0003
91743209|NCT03306433|183381116|EQUIVALENCE|Null hypothesis was that there were no differences between the groups|Paired difference t-test|-7.412|STANDARD_DEVIATION|6.049||0.0063|TWO_SIDED|||||Paired differrnce between UDMA-K18 and UDMA control|Paired difference test, 2 sided||There are 9 participant pairs for this comparison|Paired comparison||||0.0063
91743210|NCT03306433|183381117|EQUIVALENCE|The Null hypothesis was that there would be no differences between the groups|Chi Square on WSL Index frequency|15.77||||0.0033|TWO_SIDED||||||Chi-squared|||WSL Index is non-parametric||||0.0033
91743211|NCT03306433|183381117|EQUIVALENCE|The null hypothesis was that there would not be any differences between the groups|Chi Square on WSL Index frequency|6.8321||||0.145|TWO_SIDED||||||Chi-squared|||||||0.1450
91743212|NCT01575808|183381122|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0|||<|0.0001|ONE_SIDED|95.0|86.3||||z-test|One-sided z-test||A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.|||86.3|<0.0001
91743213|NCT01575808|183381123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.||||<0.0001
91743214|NCT01575808|183381124|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||<|0.0001|TWO_SIDED|95.0|96.5|100.0|||Fisher Exact||Confidence interval calculated with binomial exact method.|The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.||100|96.5|<0.0001
91743215|NCT01575808|183381125|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence intervals calculated using the binomial exact method.|||100.0|96.5|
91743216|NCT01575808|183381155|OTHER||Percentage|97.1|||||TWO_SIDED|95.0|91.7|99.4||||||||99.4|91.7|
91500439|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7 - Day 8||||0.52
91743217|NCT01575808|183381175|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence Interval calculated with binomial exact method.|||100.0|96.5|
91743218|NCT03224403|183381184|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
91743219|NCT03224403|183381184|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
91743220|NCT03224403|183381184|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
91743221|NCT03224403|183381184|SUPERIORITY|||||||0.035||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.035
91743222|NCT03224403|183381184|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||<0.001
91743223|NCT03224403|183381185|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
91743224|NCT03224403|183381185|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
91743225|NCT03224403|183381185|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
91743226|NCT03224403|183381185|SUPERIORITY|||||||0.671||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.671
91743227|NCT03224403|183381185|SUPERIORITY|||||||0.487||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.487
91743228|NCT03224403|183381186|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743229|NCT03224403|183381187|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743230|NCT03224403|183381188|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743231|NCT03224403|183381189|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743232|NCT03224403|183381190|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743233|NCT03224403|183381191|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743234|NCT03224403|183381192|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91500440|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 1||||0.52
91500441|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 8||||0.52
91500442|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 9: Day 1||||0.52
91500443|NCT03060447|182870826|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 9: Day 8||||1.00
91500444|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 10: Day 1||||0.52
91743235|NCT03224403|183381193|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743236|NCT03224403|183381194|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743237|NCT03224403|183381195|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743238|NCT03224403|183381196|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743239|NCT03224403|183381197|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743240|NCT03224403|183381198|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743241|NCT03224403|183381199|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743242|NCT03224403|183381200|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743243|NCT03224403|183381201|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91500445|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 2||||0.52
91500446|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 4||||0.52
91500447|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 8||||0.52
91743244|NCT03224403|183381202|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
91743245|NCT03224403|183381203|SUPERIORITY|||||||0.007|||||||Regression, Logistic|||||||0.007
91743246|NCT03224403|183381204|SUPERIORITY|||||||0.026|||||||Regression, Logistic|||||||0.026
91743247|NCT03224403|183381205|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.080
91743248|NCT01631747|183381234|SUPERIORITY|||||||0.01||||||p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.|t-test, 2 sided|||Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.||||0.01
91743249|NCT01631747|183381234|SUPERIORITY|||||||0.02|||||||Regression, Linear|adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.||||||0.02
91743250|NCT01631747|183381235|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||0.54
91743251|NCT01631747|183381236|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability||||||0.89
91743252|NCT01631747|183381237|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation||||||0.30
91743253|NCT01631747|183381238|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|t-test run on changes between groups. Data presented as median and IQR for ease of interpretation||||||0.69
91743254|NCT01631747|183381239|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.19
91743255|NCT01631747|183381240|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.||||||0.27
91743256|NCT01631747|183381241|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.003
91743257|NCT01631747|183381242|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.24
91743258|NCT01631747|183381243|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.32
91743259|NCT01631747|183381244|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.26
91743260|NCT01631747|183381245|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
91743261|NCT01631747|183381246|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
91743262|NCT01631747|183381247|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
91743263|NCT01631747|183381248|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
91743264|NCT01631747|183381249|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91743265|NCT01631747|183381250|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
91743266|NCT02908685|183381253|SUPERIORITY|This is the first end point and first family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.55||||0.0156|TWO_SIDED|95.0|0.3|2.81|||Mixed Model Repeated Measure Analysis|||||2.81|0.30|0.0156
91531284|NCT01607411|182939153|SUPERIORITY_OR_OTHER||Adjusted Mean difference|34.86|||<|0.0001|TWO_SIDED|95.0|30.28|39.44||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.44|30.28|<0.0001
91743267|NCT02908685|183381254|SUPERIORITY|This is the second end point and second family tested in the hierarchical testing. Logistic Regression Model.The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.35||||0.0469|TWO_SIDED|95.0|1.01|5.44||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald test|||||5.44|1.01|0.0469
91743268|NCT02908685|183381255|SUPERIORITY|This is the third end point and third family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.59||||0.0469|TWO_SIDED|95.0|0.55|2.62||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.62|0.55|0.0469
91743269|NCT02908685|183381256|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.58||||0.3902|TWO_SIDED|95.0|-0.53|1.69||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||1.69|-0.53|0.3902
91743270|NCT02908685|183381257|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.05||||0.3902|TWO_SIDED|95.0|-6.67|2.56||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.56|-6.67|0.3902
91743271|NCT02908685|183381258|SUPERIORITY|This is the sixth endpoint and the fifth family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.55||||0.3902|TWO_SIDED|95.0|0.93|4.17||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||4.17|0.93|0.3902
91743272|NCT02908685|183381259|SUPERIORITY|This is the seventh endpoint and the sixth family tested in the hierarchical testing. Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.38||||0.3902|TWO_SIDED|95.0|0.7|2.74||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald-test|||CGI Improved||2.74|0.70|0.3902
91743273|NCT02908685|183381260|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.0||||0.043|TWO_SIDED|95.0|1.02|3.93|||Wald test|||||3.93|1.02|0.0430
91743274|NCT02908685|183381262|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.64||||0.1328|TWO_SIDED|95.0|-0.2|1.47|||Mixed Model Repeated Measure Analysis|||||1.47|-0.20|0.1328
91743275|NCT02908685|183381263|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.97||||0.103|TWO_SIDED|95.0|-0.4|4.34|||Mixed Model Repeated Measure Analysis|||||4.34|-0.40|0.1030
91743276|NCT02908685|183381264|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.34||||0.0451|TWO_SIDED|95.0|0.05|4.62|||Mixed Model Repeated Measure Analysis|||||4.62|0.05|0.0451
91743277|NCT02908685|183381265|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.0489|TWO_SIDED|95.0|0.01|2.56|||Mixed Model Repeated Measure Analysis|||||2.56|0.01|0.0489
91743278|NCT02908685|183381266|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.16||||0.0326|TWO_SIDED|95.0|0.18|4.14|||Mixed Model Repeated Measure Analysis|||||4.14|0.18|0.0326
91743279|NCT02908685|183381267|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.87||||0.3029|TWO_SIDED|95.0|-8.36|2.62|||Mixed Model Repeated Measure Analysis|||||2.62|-8.36|0.3029
91743280|NCT02908685|183381268|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.4937|TWO_SIDED|95.0|-2.42|4.99|||Mixed Model Repeated Measure Analysis|||||4.99|-2.42|0.4937
91743281|NCT02908685|183381269|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.35||||0.3967|TWO_SIDED|95.0|-3.11|7.8|||Mixed Model Repeated Measure Analysis|||||7.80|-3.11|0.3967
91743282|NCT02908685|183381270|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.96||||0.6704|TWO_SIDED|95.0|-10.78|16.7|||Mixed Model Repeated Measure Analysis|||||16.70|-10.78|0.6704
91743283|NCT02908685|183381271|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-0.43||||0.8856|TWO_SIDED|95.0|-6.3|5.45|||Mixed Model Repeated Measure Analysis|||||5.45|-6.30|0.8856
91743284|NCT02908685|183381272|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.45||||0.1778|TWO_SIDED|95.0|-0.68|3.57|||Mixed Model Repeated Measure Analysis|||||3.57|-0.68|0.1778
91743285|NCT02908685|183381273|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.21||||0.6636|TWO_SIDED|95.0|0.52|2.83|||Wald-test|||CGI No Change or Improved||2.83|0.52|0.6636
91500448|NCT03060447|182870826|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 14||||0.52
91500449|NCT03060447|182870827|SUPERIORITY|||||||0.035|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 50 Copies/mL||||0.035
91531285|NCT01607411|182939153|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|28.55|||<|0.0001|TWO_SIDED|95.0|23.97|33.13||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||33.13|23.97|< 0.0001
91531286|NCT01607411|182939153|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.9292|TWO_SIDED|95.0|-4.79|4.38||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||4.38|-4.79|0.9292
91743286|NCT01691014|183381291|SUPERIORITY_OR_OTHER|||||||0.99|||||||Fisher Exact|||DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).||||0.990
91743287|NCT01691014|183381291|SUPERIORITY_OR_OTHER|||||||0.586|||||||Fisher Exact|||DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.586
91743288|NCT01691014|183381291|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.980
91743289|NCT01691014|183381292|SUPERIORITY_OR_OTHER|||||||0.945|||||||Fisher Exact|||HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.||||0.945
91743290|NCT01691014|183381292|SUPERIORITY_OR_OTHER|||||||0.458|||||||Fisher Exact|||HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.||||0.458
91743291|NCT01691014|183381292|SUPERIORITY_OR_OTHER|||||||0.896|||||||Fisher Exact|||HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.896
91743292|NCT01691014|183381292|SUPERIORITY_OR_OTHER|||||||0.39|||||||Fisher Exact|||HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.390
91743293|NCT05791565|183381312|OTHER||Ratio of Geometric LS Means|1.1609|||||TWO_SIDED|90.0|1.0221|1.3185|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.3185|1.0221|
91743294|NCT05791565|183381313|OTHER||Ratio of the Geometric LS Means|1.4081|||||TWO_SIDED|90.0|1.2998|1.5255|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5255|1.2998|
91743295|NCT05791565|183381314|OTHER||Ratio of the Geometric LS Means|1.3885|||||TWO_SIDED|90.0|1.2793|1.507|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5070|1.2793|
91743296|NCT05791565|183381315|OTHER||Ratio of the Geometric LS Means|1.3141|||||TWO_SIDED|90.0|1.1816|1.4614|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.4614|1.1816|
91743297|NCT02516982|183381349|SUPERIORITY|||||||0.994|||||||Chi-squared, Corrected|||||||0.994
91500450|NCT03060447|182870827|SUPERIORITY|||||||0.024|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 200 Copies/mL||||0.024
91500451|NCT03060447|182870828|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.67
91500452|NCT03060447|182870829|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.78
91743298|NCT02516982|183381350|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
91743299|NCT02516982|183381351|SUPERIORITY|||||||0.008|||||||Chi-squared, Corrected|||||||0.008
91743300|NCT02516982|183381352|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
91743301|NCT02516982|183381353|SUPERIORITY|||||||0.0001467|||||||Chi-squared, Corrected|||||||0.0001467
91743302|NCT02516982|183381354|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
91743303|NCT02516982|183381355|SUPERIORITY|||||||0.869|||||||Chi-squared, Corrected|||||||0.869
91743304|NCT00924612|183381389|OTHER||Odds Ratio, log|130.83|STANDARD_ERROR_OF_MEAN|0.0844||0.0025|TWO_SIDED|90.0|113.59|150.7|||t-test, 2 sided|||Comparison of diets based on full crossover model|ANOVA of a multicenter, 4 sequence, 5 treatment crossover model using ln-transformed data. Normal fat diet compared to fasting, very low fat, low fat, and high fat diets as part of the overall analysis. No adjustments for multiplicity made.|150.70|113.59|0.0025
91743305|NCT00924612|183381389|OTHER||Odds Ratio, log|101.84|STANDARD_ERROR_OF_MEAN|0.0954||0.8494|TWO_SIDED|90.0|86.8|119.47|||t-test, 2 sided|||Comparison of diets based on full crossover model||119.47|86.80|0.8494
91743306|NCT00924612|183381389|OTHER||Odds Ratio, log|73.55|STANDARD_ERROR_OF_MEAN|0.0902||0.0013|TWO_SIDED|90.0|63.23|85.55|||t-test, 2 sided|||Comparison of diets based on full crossover model||85.55|63.23|0.0013
91743307|NCT00924612|183381389|OTHER||Odds Ratio, log|62.62|STANDARD_ERROR_OF_MEAN|0.0954|<|0.0001|TWO_SIDED|90.0|53.38|76.46|||t-test, 2 sided|||Comparison of diets based on full crossover model||76.46|53.38|<0.0001
91743308|NCT03818607|183381393|NON_INFERIORITY|The clinical similarity of the Week 27 LDH between treatments was assessed by comparing the 1-sided 97.5% upper confidence interval (CI) limit for the geometric mean ratio of LDH at Week 27 between ABP 959 treatment and eculizumab treatment with a non-inferiority margin of 2.873.|Geometric LS mean ratio (GMR)|1.0628|||||ONE_SIDED|97.5||1.1576||||||||1.1576||
91743309|NCT03818607|183381394|OTHER|The clinical similarity of the AUEC between treatments was assessed by comparing 2-sided 90% CI for the GMR of the time-adjusted AUEC of LDH (Week 13 to Week 27, Week 39 to Week 53, and Week 65 to Week 79) between ABP 959 treatment and eculizumab treatment with a similarity margin of (0.77, 1.30).|GMR|0.9812|||||TWO_SIDED|90.0|0.9403|1.0239||||||||1.0239|0.9403|
91743310|NCT03818607|183381402|OTHER||GMR|1.0314|||||ONE_SIDED|97.5||1.1201||||||||1.1201||
91743311|NCT03818607|183381405|OTHER||GMR|0.9122|||||TWO_SIDED|90.0|0.7586|1.0968||||||Total PK AUC GMR (ABP 959/Eculizumab)||1.0968|0.7586|
91743312|NCT03818607|183381405|OTHER||GMR|0.9508|||||TWO_SIDED|90.0|0.7454|1.213||||||Unbound PK AUC GMR (ABP 959/Eculizumab)||1.2130|0.7454|
91743313|NCT01147250|183381419|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.3.|Hazard Ratio (HR)|1.017|||||TWO_SIDED|95.0|0.886|1.168|||||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).||1.168|0.886|
91500453|NCT03060447|182870830|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Baseline||||0.34
91743314|NCT01147250|183381419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.8542|TWO_SIDED|95.0|0.886|1.168|||Log Rank||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.0.||1.168|0.886|0.8542
91743315|NCT03588806|183381423|SUPERIORITY|||||||0.218|||||||ANOVA|Univariate repeated measures ANOVA||||||0.218
91743316|NCT03588806|183381424|SUPERIORITY|||||||0.268|||||||ANOVA|Univariate repeated measures||||||0.268
91743317|NCT03588806|183381425|SUPERIORITY||||||<|0.001|||||||ANOVA|Univariate repeated measures ANOVA||||||<0.001
91743318|NCT03588806|183381426|SUPERIORITY|||||||0.228|||||||ANOVA|Univariate repeated measures ANOVA||||||0.228
91743319|NCT03588806|183381427|SUPERIORITY|||||||0.043|||||||ANOVA|Univariate repeated measures ANOVA||||||0.043
91743320|NCT03588806|183381428|SUPERIORITY|||||||0.486|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Social Roles score||||0.486
91743321|NCT03588806|183381428|SUPERIORITY|||||||0.078|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Sleep Disturbance T-Scores||||0.078
91743322|NCT03588806|183381428|SUPERIORITY|||||||0.874|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Depression T-Scores||||0.874
91743323|NCT03588806|183381428|SUPERIORITY|||||||0.389|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Anxiety T-Score||||0.389
91743324|NCT03588806|183381429|SUPERIORITY|||||||0.676|||||||ANOVA|Univariate repeated measures ANOVA||||||0.676
91500454|NCT03060447|182870830|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 2||||0.11
91500455|NCT03060447|182870830|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 8||||0.81
91743325|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Specificity of lesion shape|0.694|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||Null hypothesis is that there is no difference between the two tests.||||<0.001
91743326|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, conservative|0.714|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
91743327|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, agressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
91743328|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Max. elasticity specificity,conservative|0.657||||0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.001
91743329|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Max. elasticity specificity, aggressive|0.774|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||<0.001
91743330|NCT00716482|183381443|SUPERIORITY_OR_OTHER||median mean elasticity value specificity|0.626||||0.18|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.18
91743331|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Diameter ratio specificity|0.512||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
91743332|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Median elasticity ratio specificity|0.649||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
91743333|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Max.color scale specificity,conservative|0.703|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
91743334|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Max. color scale specificity, aggressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall specificity = 78.5%"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
91743335|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Lesion shape sensitivity|0.979||||0.48|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image lesion shape.~Null hypothesis is that there is no difference between the two tests."||||0.48
91500456|NCT03060447|182870830|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 1||||0.83
91743336|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Lesion homogeneity sens, conservative|0.969||||0.74|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.74
91743337|NCT00716482|183381443|SUPERIORITY_OR_OTHER||elasticity homogeneity,aggressive,sensit|0.962||||0.37|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.37
91743338|NCT00716482|183381443|SUPERIORITY_OR_OTHER||elasticity homegeneity,conservative,sens|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall sensitivity = 99.0%"|McNemar|||"Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.025
91743339|NCT00716482|183381443|SUPERIORITY_OR_OTHER||max. elasticity sensitivity,aggressive|0.972|||>|0.99|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||>0.99
91743340|NCT00716482|183381443|SUPERIORITY_OR_OTHER||median mean elasticity value sensitivity|0.986||||0.046|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.046
91743341|NCT00716482|183381443|SUPERIORITY_OR_OTHER||diameter ratio sensitivity|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.025
91743342|NCT00716482|183381443|SUPERIORITY_OR_OTHER||median elasticity ratio sensitivity|0.983||||0.083|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.083
91743343|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Max.color scale sensitivity,conservative|0.997||||0.008|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||0.008
91743344|NCT00716482|183381443|SUPERIORITY_OR_OTHER||Max. color scale sensitivity, aggressive|0.986||||0.21|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||0.21
91743345|NCT00716482|183381444|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Kruskal-Wallis one-way ANOVA. Kruskal-Wallis was performed once to get p-values for all of the 9 categories at once.||Null hypothesis: no variance of similarity exists between the three groups||||<0.001
91743346|NCT03249909|183381447|NON_INFERIORITY|Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups with the two-sided Sign test on the Intent To Treat (ITT) population at 95% confidence interval.||||||0.0019|||||||Sign test|||||||0.0019
91743347|NCT03517371|183381457|SUPERIORITY||Mean Difference (Final Values)|72.35||||0.89|TWO_SIDED|95.0|-943.34|1088.04|||t-test, 2 sided|||||1088.04|-943.34|.89
91743348|NCT03517371|183381458|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.42|TWO_SIDED|95.0|-3.8|3.1|||t-test, 2 sided|||||3.10|-3.80|.42
91743349|NCT03517371|183381459|SUPERIORITY||Median Difference (Final Values)|2.17||||0.85|TWO_SIDED|95.0|-20.64|24.97|||t-test, 2 sided|Levene's test significant, equal variances not assumed values reported.||||24.97|-20.64|.85
91743350|NCT03517371|183381460|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.824|TWO_SIDED|95.0|-0.081|0.065|||t-test, 2 sided|||||.065|-.081|.824
91743351|NCT01345929|183381462|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|2.31|14.57||||||||14.57|2.31|
91743352|NCT01345929|183381463|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|1.95|13.97||||||||13.97|1.95|
91743353|NCT02819297|183381464|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91743354|NCT02674464|183381484|SUPERIORITY||Odds Ratio (OR)|0.9||||0.68|TWO_SIDED|95.0|0.62|1.3||The a priori threshold for statistical significance was \<0.05.|Generalized Estimating Equations (GEE)|Assuming an exchangeable correlation structure|CC/SC arm compared to the SCP arm.|||1.30|0.62|0.68
91743355|NCT02674464|183381485|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.6|TWO_SIDED|95.0|-1.32|2.3||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm was compared to the SCP arm.|||2.30|-1.32|0.60
91743356|NCT02674464|183381486|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.38|TWO_SIDED|95.0|-1.04|2.71||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression|||||2.71|-1.04|0.38
91743357|NCT02674464|183381487|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.05|TWO_SIDED|95.0|-2.43|0.01||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm compared to SCP arm.|||0.01|-2.43|0.05
91743358|NCT01262638|183381519|SUPERIORITY||Difference in Least Squares Means|-15.7|||<|0.0001|TWO_SIDED|95.0|-21.8|-9.7|||ANCOVA|||||-9.7|-21.8|<0.0001
91743359|NCT01262638|183381519|SUPERIORITY||Difference in Least Squares Means|-22.9|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.9|||ANCOVA|||||-16.9|-28.9|<0.0001
91743360|NCT01262638|183381519|SUPERIORITY||Difference in Least Squares Means|-24.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-18.4|||ANCOVA|||||-18.4|-30.5|<0.0001
91743361|NCT00260832|183381547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1079|TWO_SIDED|95.0|||||Kaplan-Meier|||The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status||||0.1079
91743362|NCT00260832|183381548|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0011|TWO_SIDED|95.0|1.4|4.78|||Fisher Exact|||||4.78|1.40|0.0011
91743363|NCT01104545|183381567|OTHER||Geometric mean ratio (GMR)|1.0|||||||||||||GMR = Fed/Fasted|||||
91743364|NCT01104545|183381568|OTHER||GMR|0.73|||||||||||||GMR = Fed/fasted|||||
91743365|NCT02285023|183381609|NON_INFERIORITY_OR_EQUIVALENCE|Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|||||<|0.01||||||An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5|exploratory factor analysis|An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5||Exploratory factor analysis||||<0.01
91743366|NCT02285023|183381610|SUPERIORITY_OR_OTHER||Cronbach's alpha|0.94|||<|0.05|TWO_SIDED||||||Crohbach's alpha|||||||<0.05
91743367|NCT00809926|183381613|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6||||0.295|TWO_SIDED|95.0|-4.61|1.4|||ANCOVA|||||1.40|-4.61|0.295
91743368|NCT00809926|183381614|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.79|TWO_SIDED|95.0|-1.93|1.47|||ANCOVA|||||1.47|-1.93|0.790
91500457|NCT03060447|182870830|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 2||||0.12
91743369|NCT00809926|183381615|SUPERIORITY_OR_OTHER||Difference|8.1||||0.101|TWO_SIDED|95.0|-1.56|17.67|||Cochran-Mantel-Haenszel|||||17.67|-1.56|0.101
91743370|NCT00809926|183381616|SUPERIORITY_OR_OTHER||Difference|11.6||||0.018|TWO_SIDED|95.0|2.0|21.33|||Cochran-Mantel-Haenszel|||||21.33|2.00|0.018
91743371|NCT00809926|183381619|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.4||||0.028|TWO_SIDED|95.0|-6.34|-0.37|||ANCOVA|||||-0.37|-6.34|0.028
91743372|NCT00809926|183381620|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.04|TWO_SIDED|95.0|-6.02|-0.14|||GENMOD|Based on a generalized estimating equations using SAS procedure GENMOD.||||-0.14|-6.02|0.040
91743373|NCT00809926|183381621|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.7||||0.004|TWO_SIDED|95.0|-14.38|-2.93|||ANCOVA|||||-2.93|-14.38|0.004
91743374|NCT00809926|183381622|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.9||||0.006|TWO_SIDED|95.0|-8.37|-1.42|||ANCOVA|||||-1.42|-8.37|0.006
91743375|NCT01108731|183381625|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
91743376|NCT01108731|183381626|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
91743377|NCT01108731|183381627|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91743378|NCT02227810|183381673|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
91743379|NCT02227810|183381673|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
91743380|NCT02227810|183381674|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||||||0.051
91500458|NCT03060447|182870830|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 8||||0.45
91743381|NCT02227810|183381674|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91743382|NCT02227810|183381675|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
91743383|NCT02227810|183381676|SUPERIORITY_OR_OTHER|||||||0.792|||||||t-test, 2 sided|||||||0.792
91743384|NCT00819156|183381701|SUPERIORITY_OR_OTHER_LEGACY||Percentage|61.0||||||95.0|41.0|78.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||78|41|
91743385|NCT00819156|183381701|SUPERIORITY_OR_OTHER_LEGACY||Percentage|84.0||||||95.0|64.0|95.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||95|64|
91743386|NCT00819156|183381701|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|81.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|81|
91743387|NCT00819156|183381701|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
91743388|NCT00819156|183381701|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
91743389|NCT00819156|183381701|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|74.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||99|74|
91743390|NCT00819156|183381702|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|80.0|98.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|80|
91743391|NCT00819156|183381702|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|86.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|86|
91743392|NCT00819156|183381702|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0||||||95.0|93.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|93|
91500459|NCT03060447|182870830|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 1||||0.25
91743393|NCT00819156|183381703|SUPERIORITY_OR_OTHER_LEGACY||Percentage|70.0||||||95.0|51.0|85.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||85|51|
91743394|NCT00819156|183381703|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|75.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|75|
91743395|NCT00819156|183381703|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|84.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|84|
91743396|NCT00819156|183381703|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|83.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|83|
91743397|NCT00819156|183381703|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|80.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|80|
91743398|NCT00819156|183381703|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|77.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|77|
91743399|NCT00819156|183381704|SUPERIORITY_OR_OTHER_LEGACY||Percentage|83.0||||||95.0|65.0|94.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||94|65|
91743400|NCT00819156|183381704|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|79.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|79|
91743401|NCT00819156|183381704|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.0||||||95.0|70.0|96.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||96|70|
91500460|NCT03060447|182870830|SUPERIORITY|||||||0.053|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 2||||0.053
91743402|NCT00819156|183381704|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
91743403|NCT00819156|183381704|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|76.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|76|
91500461|NCT03060447|182870830|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 8||||0.16
91500462|NCT03060447|182870830|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, ATI Remission Visit||||0.27
91500463|NCT03060447|182870830|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Baseline||||0.35
91743404|NCT00819156|183381704|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
91743405|NCT00819156|183381705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933||95.0|||||Log Rank|||||||0.0933
91743406|NCT00819156|183381706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165||95.0|||||Log Rank|||||||0.165
91743407|NCT00819156|183381707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.429||95.0|||||Log Rank|||||||0.429
91743408|NCT00943098|183381737|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.71||||0.813|TWO_SIDED|95.0|-6.62|5.2|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.20|-6.62|0.813
91743409|NCT00943098|183381750|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.51||||0.862|TWO_SIDED|95.0|-6.23|5.22|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.22|-6.23|0.862
91760150|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.12|||||TWO_SIDED|95.0|3.54|8.7||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.70|3.54|
91500464|NCT03060447|182870830|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 2||||0.013
91500465|NCT03060447|182870830|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 8||||0.15
91500466|NCT03060447|182870830|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 1||||0.30
91500467|NCT03060447|182870830|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 2||||0.003
91500468|NCT03060447|182870830|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 8||||0.49
91743410|NCT00281099|183381751|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates.|Hazard Ratio (HR)|1.139||||||96.3|1.139|1.59||There were 167 events by 90 subjects in the VVI 40 arm, compared to 188 events among 104 subjects in the MVP arm.|Andersen-Gill Model|An Andersen-Gill model was used to account for multiple primary endpoints per subject.|4 interim analyses were performed \& the O'Brien-Fleming alpha-spending function required a 96.3% confidence interval.|"This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40."||1.590|1.139|
91743411|NCT00281099|183381752|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.241. The one-sided upper confidence bound for the hazard ratio had to be less than 1.241 for the null hypothesis to be rejected. The threshold of 1.241 was derived by using a non-inferiority threshold of a 5 percentage point difference in 24 month HF event-free rates.|Hazard Ratio (HR)|1.029||||||95.0|1.029|1.381|||Andersen-Gill Model|An Andersen-Gill model was utilized to account for multiple HF events per subject.||This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.||1.381|1.029|
91743412|NCT00281099|183381753|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interactions between randomization arm and time.|Cumulative Logits Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.||||> 0.05
91743413|NCT00281099|183381753|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interaction terms between randomization arm and time.|Cumulative Logit Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.||||> 0.05
91743414|NCT00281099|183381754|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Model fit with time and arm as covariates, the interaction between them included. Interaction shown to not be significant and model refit without it.||A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
91743415|NCT00281099|183381755|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
91500469|NCT03060447|182870830|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 1||||0.25
91500470|NCT03060447|182870830|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 2||||0.055
91743416|NCT00281099|183381756|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|The model was fit with time and arm as covariates.||"A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.0424
91743417|NCT00281099|183381756|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Models were fit with time and arm as covariates.||"Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume."||||>0.10
91743418|NCT00281099|183381757|SUPERIORITY_OR_OTHER|||||||0.0418||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|The model fit with time and arm as covariates.||A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.0418
91743419|NCT00281099|183381758|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
91500471|NCT03060447|182870830|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 8||||0.90
91743420|NCT00281099|183381759|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Model fit with time and arm as covariates.||A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.9490
91743421|NCT00281099|183381760|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models fit with time and arm as covariates.||A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
91743422|NCT00281099|183381761|SUPERIORITY_OR_OTHER|||||||0.8403||95.0||||The a priori threshold for significance for Arm was 0.05.|Cumulative Logits Model|Because Composite Mitral Regurgitation Score was measured on the ordinal scale, a GEE cumulative logits model was fit.||"A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.8403
91743423|NCT00281099|183381762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||||95.0|0.949|1.209|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which true VT/VF occurred) within subject.|Because of the possible correlation within subject of days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.209|0.949|
91743424|NCT00281099|183381762|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|-0.015||||||95.0|-0.015|0.033|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.033|-0.015|
91743425|NCT00281099|183381762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||||95.0|1.31|1.858|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which non-VT/VF detected by device as VT/VF) within subject.|Because of the possible correlation within a subject for days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.858|1.310|
91500472|NCT03060447|182870830|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, ATI Remission Visit||||0.39
91500473|NCT03060447|182870830|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Baseline||||0.75
91500474|NCT03060447|182870830|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 2||||<0.001
91500475|NCT03060447|182870830|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 8||||0.69
91500476|NCT03060447|182870830|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 1||||0.15
91500477|NCT03060447|182870830|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 2||||0.018
91500478|NCT03060447|182870830|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 8||||0.030
91500479|NCT03060447|182870830|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 1||||0.087
91500480|NCT03060447|182870830|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 2||||<0.001
91531287|NCT01607411|182939153|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1||||0.0094|TWO_SIDED|95.0|1.52|10.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.69|1.52|0.0094
91743426|NCT00281099|183381762|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|0.017||||||95.0|0.017|0.036|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.036|0.017|
91743427|NCT00281099|183381763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.7166||95.0|1.22|3.0||The threshold for significance was the one-sided upper confidence bound being less than 1.|Andersen-Gill model|||This analysis compared the hazard rates for clinically important AF (defined as a calendar day with \>20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.||3.0|1.22|0.7166
91500481|NCT03060447|182870830|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 8||||0.066
91500482|NCT03060447|182870830|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, ATI Remission||||0.86
91743428|NCT00281099|183381763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-100.0|0.8||The threshold for significance was defined as the upper one-sided confidence bound being less than 0.|Bootstrap Confidence Interval|||This analysis compared the percentage of days with \>20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.||0.8|-100|
91743429|NCT00281099|183381763|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||The a priori threshold for statistical significance was 0.05.|Log Rank|A one-sided test was used.||This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or \< 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.||||0.325
91500483|NCT03060447|182870830|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Baseline||||0.19
91500484|NCT03060447|182870830|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 2||||0.021
91500485|NCT03060447|182870830|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 8||||0.31
91500486|NCT03060447|182870830|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 1||||0.10
91500487|NCT03060447|182870830|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 2||||0.018
91500488|NCT03060447|182870830|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 8||||0.69
91500489|NCT03060447|182870830|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 1||||0.46
91500490|NCT03060447|182870830|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 2||||0.21
91500491|NCT03060447|182870830|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 8||||0.67
91500492|NCT03060447|182870830|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, ATI Remission||||0.60
91500493|NCT03060447|182870831|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 1: Day 2||||0.002
91500494|NCT03060447|182870831|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 1||||0.58
91500495|NCT03060447|182870831|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 2||||0.009
91500496|NCT03060447|182870831|SUPERIORITY|ISG15, Dose 10: Day 1||||||0.031|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.031
91500497|NCT03060447|182870831|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 10: Day 2||||0.001
91743430|NCT00281099|183381763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.145||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF through 6 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.145|0|
91743431|NCT00281099|183381763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.227||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 6 to 12 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.227|0|
91743432|NCT00281099|183381763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.261||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 12 to 24 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.261|0|
91500498|NCT03060447|182870831|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 1: Day 2||||0.003
91500499|NCT03060447|182870831|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 1||||0.057
91500500|NCT03060447|182870831|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 2||||0.009
91500501|NCT03060447|182870831|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 1||||0.057
91500502|NCT03060447|182870831|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 2||||0.005
91500503|NCT03060447|182870831|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 1: Day 2||||<0.001
91743433|NCT00281099|183381763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||||95.0|-0.1|0.11||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 24 to 36 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.110|-0.1|
91743434|NCT00281099|183381764|SUPERIORITY_OR_OTHER|||||||0.0053||95.0||||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.|Log Rank|||Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.||||0.0053
91743435|NCT00281099|183381766|SUPERIORITY_OR_OTHER|||||||0.9791||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.||||0.9791
91760151|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73|||||TWO_SIDED|95.0|2.19|7.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.26|2.19|
91760152|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.18|||||TWO_SIDED|95.0|-0.39|4.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.76|-0.39|
91500504|NCT03060447|182870831|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 1||||0.17
91500505|NCT03060447|182870831|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 2||||0.003
91500506|NCT03060447|182870831|SUPERIORITY|MX1, Dose 10: Day 1||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.100
91500507|NCT03060447|182870831|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 10: Day 2||||<0.001
91500508|NCT03060447|182870832|SUPERIORITY|||||||0.7469|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Baseline||||0.7469
91500509|NCT03060447|182870832|SUPERIORITY|||||||0.1207|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 1||||0.1207
91500510|NCT03060447|182870832|SUPERIORITY|||||||0.4113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 2||||0.4113
91500511|NCT03060447|182870832|SUPERIORITY|||||||0.1113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 4||||0.1113
91500512|NCT03060447|182870832|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 1||||0.2410
91500513|NCT03060447|182870832|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 4||||0.1098
91500514|NCT03060447|182870832|SUPERIORITY|||||||0.0369|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 1||||0.0369
91500515|NCT03060447|182870832|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 2||||0.0814
91500516|NCT03060447|182870832|SUPERIORITY|||||||0.1658|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 4||||0.1658
91531288|NCT01607411|182939153|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.31||||0.0073|TWO_SIDED|95.0|1.72|10.89||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.89|1.72|0.0073
91531289|NCT01607411|182939154|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.98||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random factor|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.98|0.58|<0.0001
91743436|NCT00281099|183381766|SUPERIORITY_OR_OTHER|||||||0.8984||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 12 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.||||0.8984
91743437|NCT00281099|183381766|SUPERIORITY_OR_OTHER|||||||0.7144||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 24 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.7144
91500517|NCT03060447|182870832|SUPERIORITY|||||||0.9431|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 14||||0.9431
91500518|NCT03060447|182870832|SUPERIORITY|||||||0.6514|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Baseline||||0.6514
91500519|NCT03060447|182870832|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 1||||0.0821
91743438|NCT00281099|183381766|SUPERIORITY_OR_OTHER|||||||0.5165||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 36 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.5165
91743439|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||The p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0073
91743440|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.2493||95.0||||No adjustment was made for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.2493
91500520|NCT03060447|182870832|SUPERIORITY|||||||0.2353|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 2||||0.2353
91500521|NCT03060447|182870832|SUPERIORITY|||||||0.1779|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 4||||0.1779
91500522|NCT03060447|182870832|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 1||||0.7491
91500523|NCT03060447|182870832|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 4||||0.0700
91500524|NCT03060447|182870832|SUPERIORITY|||||||0.3711|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 1||||0.3711
91531290|NCT01607411|182939154|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.79|||<|0.0001|TWO_SIDED|95.0|0.58|0.99||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.99|0.58|<0.0001
91500525|NCT03060447|182870832|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 2||||0.0814
91500526|NCT03060447|182870832|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 4||||0.0700
91743441|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.7728||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.7728
91743442|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.3082||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.3082
91743443|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.5422||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.5422
91743444|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.0851||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0851
91743445|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.0502||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0502
91743446|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.0463||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0463
91743447|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.0227||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0227
91743448|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.0582||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0582
91743449|NCT00281099|183381767|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all ten KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|||The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.||||> 0.15
91743450|NCT00281099|183381767|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all 10 KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in these analyses.||The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.||||> 0.15
91743451|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.1399||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.||||0.1399
91743452|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.3573||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.||||0.3573
91743453|NCT00281099|183381767|SUPERIORITY_OR_OTHER|||||||0.5183||95.0||||The a priori threshold for statistical significance was 0.05, with no adjustment made for multiple comparisons.|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in this analysis.||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.||||0.5183
91500527|NCT03060447|182870832|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 14||||0.8303
91500528|NCT03060447|182870832|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Baseline||||0.9530
91500529|NCT03060447|182870832|SUPERIORITY|||||||0.1735|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 1||||0.1735
91500530|NCT03060447|182870832|SUPERIORITY|||||||0.2971|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 2||||0.2971
91500531|NCT03060447|182870832|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 4||||1.0000
91500532|NCT03060447|182870832|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 1||||1.0000
91500533|NCT03060447|182870832|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 4||||0.3374
91531291|NCT01607411|182939154|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.69|0.29|< 0.0001
91531292|NCT01607411|182939154|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.005||||0.9631|TWO_SIDED|95.0|-0.21|0.2||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.20|-0.21|0.9631
91500534|NCT03060447|182870832|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 1||||0.7656
91500535|NCT03060447|182870832|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 2||||0.0814
91500536|NCT03060447|182870832|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 4||||0.3374
91500537|NCT03060447|182870832|SUPERIORITY|||||||0.432|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 14||||0.4320
91500538|NCT03060447|182870832|SUPERIORITY|||||||0.8597|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Baseline||||0.8597
91500539|NCT03060447|182870832|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 1||||1.0000
91500540|NCT03060447|182870832|SUPERIORITY|||||||0.0306|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 2||||0.0306
91500541|NCT03060447|182870832|SUPERIORITY|||||||0.8345|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 4||||0.8345
91500542|NCT03060447|182870832|SUPERIORITY|||||||0.9151|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 1||||0.9151
91500543|NCT03060447|182870832|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 4||||0.1098
91500544|NCT03060447|182870832|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 1||||1.0000
91531293|NCT01607411|182939154|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29||||0.0047|TWO_SIDED|95.0|0.09|0.49||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.49|0.09|0.0047
91500545|NCT03060447|182870832|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 2||||0.0814
91500546|NCT03060447|182870832|SUPERIORITY|||||||0.4555|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 4||||0.4555
91500547|NCT03060447|182870832|SUPERIORITY|||||||0.6171|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 14||||0.6171
91500548|NCT03060447|182870832|SUPERIORITY|||||||0.0677|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Baseline||||0.0677
91500549|NCT03060447|182870832|SUPERIORITY|||||||0.4712|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 1||||0.4712
91500550|NCT03060447|182870832|SUPERIORITY|||||||0.6889|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 2||||0.6889
91500551|NCT03060447|182870832|SUPERIORITY|||||||0.1437|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 4||||0.1437
91500552|NCT03060447|182870832|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 1||||0.7491
91500553|NCT03060447|182870832|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 4||||0.0700
91500554|NCT03060447|182870832|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 1||||0.7656
91500555|NCT03060447|182870832|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 2||||0.1752
91500556|NCT03060447|182870832|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 4||||0.0700
91743454|NCT00281099|183381768|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.44. The one-sided upper confidence bound for the hazard ratio had to be less than 1.44 for the null hypothesis to be rejected. The threshold of 1.44 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month survival rates.|Hazard Ratio (HR)|1.26||||||95.0|1.26|1.75|||||This was a non-inferiority analysis, and so a one-sided 95% confidence interval was performed comparing the MVP arm to the VVI 40 arm.|The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.||1.75|1.26|
91743455|NCT01082081|183381771|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.77||||0.0004|TWO_SIDED|95.0|2.15|7.39|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.||7.39|2.15|0.0004
91743456|NCT01082081|183381771|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.25|||<|0.0001|TWO_SIDED|95.0|4.04|10.45|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||10.45|4.04|<0.0001
91743457|NCT01082081|183381771|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.48||||0.1307|TWO_SIDED|95.0|-0.74|5.69|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 500 mg caplet and placebo caplet.||5.69|-0.74|0.1307
91743458|NCT03159468|183381786|OTHER|||||||0.041||||||This p-value is for the main effect of beverage condition.|ANOVA|||||||.041
91743459|NCT03159468|183381786|OTHER|||||||0.16||||||This p-value is for the main effect of intervention condition.|ANOVA|||||||.160
91743460|NCT03159468|183381786|OTHER|||||||0.462||||||This p-value is for the beverage condition by intervention condition interaction.|ANOVA|||||||.462
91743461|NCT00335283|183381824|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.12||||0.01|TWO_SIDED|95.0|1.28|7.59|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||7.59|1.28|.01
91743462|NCT00335283|183381824|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.5||||0.006|TWO_SIDED|95.0|1.41|8.67|||Regression, Logistic|||This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||8.67|1.41|.006
91500557|NCT03060447|182870832|SUPERIORITY|CD69+CD56brCD16dim, Dose 10: Day 14||||||0.2246|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.2246
91500558|NCT04249310|182870948|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.46|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox-regression was used to estimate the hazard ratios and 95% confidence intervals.|||2.46|0.32|
91743463|NCT00335283|183381825|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.01||||0.97|TWO_SIDED|95.0|0.38|2.7|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||2.70|0.38|.97
91743464|NCT00335283|183381825|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.11||||0.84|TWO_SIDED|95.0|0.4|3.06|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||3.06|0.40|.84
91743465|NCT00335283|183381826|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.44||||0.06|TWO_SIDED|95.0|0.95|6.31|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||6.31|.95|.06
91743466|NCT00335283|183381826|SUPERIORITY_OR_OTHER||Odds Ratio, log|4.51||||0.007|TWO_SIDED|95.0|1.5|13.6|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.6|1.5|.007
91760153|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41|||||TWO_SIDED|95.0|2.83|7.99||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.99|2.83|
91743467|NCT00335283|183381827|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.17||||0.006|TWO_SIDED|95.0|2.02|13.2|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.2|2.02|.006
91743468|NCT00335283|183381827|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.31||||0.001|TWO_SIDED|95.0|1.97|14.3|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||14.3|1.97|.001
91743469|NCT01734395|183381839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|4.56|<|0.0001|TWO_SIDED|95.0|-1.4262|-0.9467|||t-test, 2 sided|||||-0.9467|-1.4262|<.0001
91743470|NCT01734395|183381840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|10.69|<|0.0001|TWO_SIDED|95.0|0.9188|2.0438|||t-test, 2 sided|||||2.0438|0.9188|<.0001
91743471|NCT01734395|183381841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|2.43|<|0.0001|TWO_SIDED|95.0|-0.814|-0.5586|||t-test, 2 sided|||||-0.5586|-0.814|<.0001
91743472|NCT02565147|183381858|SUPERIORITY|||||||0.7505|||||||Wilcoxon Rank Sum Test|||||||0.7505
91743473|NCT04855240|183381869|SUPERIORITY||LSM difference|-10.5|STANDARD_ERROR_OF_MEAN|7.61||0.1683|TWO_SIDED|95.0|-25.4|4.4|||ANOVA|||||4.4|-25.4|0.1683
91743474|NCT04855240|183381869|SUPERIORITY||LSM difference|1.6|STANDARD_ERROR_OF_MEAN|7.64||0.8356|TWO_SIDED|95.0|-13.4|16.6|||ANOVA|||||16.6|-13.4|0.8356
91743475|NCT04855240|183381870|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.228|TWO_SIDED|95.0|0.598|1.155|||Log Rank|||||1.155|0.598|0.2280
91743476|NCT04855240|183381870|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5604|TWO_SIDED|95.0|0.793|1.527|||Log Rank|||||1.527|0.793|0.5604
91743477|NCT04855240|183381871|SUPERIORITY||Risk Difference (RD)|0.11||||0.2457|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.05|0.2457
91743478|NCT04855240|183381871|SUPERIORITY||Risk Difference (RD)|-0.06||||0.3997|TWO_SIDED|95.0|-0.22|0.09|||Cochran-Mantel-Haenszel|||||0.09|-0.22|0.3997
91743479|NCT04855240|183381872|SUPERIORITY||Risk Difference (RD)|0.07||||0.4771|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4771
91743480|NCT04855240|183381872|SUPERIORITY||Risk Difference (RD)|-0.09||||0.2925|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.2925
91743481|NCT04855240|183381873|SUPERIORITY||Risk Difference (RD)|0.07||||0.4628|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4628
91743482|NCT04855240|183381873|SUPERIORITY||Risk Difference (RD)|-0.09||||0.309|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.3090
91743483|NCT04855240|183381874|SUPERIORITY||LSM difference|-17.7|STANDARD_ERROR_OF_MEAN|15.36||0.2494|TWO_SIDED|95.0|-47.8|12.4|||ANOVA|||||12.4|-47.8|0.2494
91743484|NCT04855240|183381874|SUPERIORITY||LSM difference|5.1|STANDARD_ERROR_OF_MEAN|15.42||0.7385|TWO_SIDED|95.0|-25.1|35.4|||ANOVA|||||35.4|-25.1|0.7385
91743485|NCT04855240|183381875|SUPERIORITY||LSM difference|-22.6|STANDARD_ERROR_OF_MEAN|22.91||0.3238|TWO_SIDED|95.0|-67.5|22.3|||ANOVA|||||22.3|-67.5|0.3238
91743486|NCT04855240|183381875|SUPERIORITY||LSM difference|7.8|STANDARD_ERROR_OF_MEAN|22.99||0.7344|TWO_SIDED|95.0|-37.3|52.9|||ANOVA|||||52.9|-37.3|0.7344
91743487|NCT04855240|183381876|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|1.72||0.8489|TWO_SIDED|95.0|-3.7|3.0|||ANOVA|||||3.0|-3.7|0.8489
91743488|NCT04855240|183381876|SUPERIORITY||LSM difference|1.9|STANDARD_ERROR_OF_MEAN|1.72||0.2768|TWO_SIDED|95.0|-1.5|5.3|||ANOVA|||||5.3|-1.5|0.2768
91743489|NCT04855240|183381877|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|2.54||0.6291|TWO_SIDED|95.0|-6.2|3.8|||ANOVA|||||3.8|-6.2|0.6291
91743490|NCT04855240|183381877|SUPERIORITY||LSM difference|2.5|STANDARD_ERROR_OF_MEAN|2.55||0.3182|TWO_SIDED|95.0|-2.5|7.5|||ANOVA|||||7.5|-2.5|0.3182
91743491|NCT04855240|183381878|SUPERIORITY||LSM difference|-4.2|STANDARD_ERROR_OF_MEAN|4.35||0.3299|TWO_SIDED|95.0|-12.8|4.3|||ANOVA|||||4.3|-12.8|0.3299
91743492|NCT04855240|183381878|SUPERIORITY||LSM difference|0.6|STANDARD_ERROR_OF_MEAN|4.37||0.8822|TWO_SIDED|95.0|-7.9|9.2|||ANOVA|||||9.2|-7.9|0.8822
91743493|NCT04855240|183381879|SUPERIORITY||LSM difference|-7.1|STANDARD_ERROR_OF_MEAN|8.62||0.4094|TWO_SIDED|95.0|-24.0|9.8|||ANOVA|||||9.8|-24.0|0.4094
91743494|NCT04855240|183381879|SUPERIORITY||LSM difference|3.4|STANDARD_ERROR_OF_MEAN|8.65||0.6901|TWO_SIDED|95.0|-13.5|20.4|||ANOVA|||||20.4|-13.5|0.6901
91743495|NCT04855240|183381880|SUPERIORITY||LSM difference|-5.1|STANDARD_ERROR_OF_MEAN|8.59||0.5536|TWO_SIDED|95.0|-21.9|11.7|||ANOVA|||||11.7|-21.9|0.5536
91743496|NCT04855240|183381880|SUPERIORITY||LSM difference|2.4|STANDARD_ERROR_OF_MEAN|8.64||0.7811|TWO_SIDED|95.0|-14.5|19.3|||ANOVA|||||19.3|-14.5|0.7811
91743497|NCT04855240|183381881|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.5267|TWO_SIDED|95.0|-0.8|0.4|||ANOVA|||||0.4|-0.8|0.5267
91743498|NCT04855240|183381881|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3228|TWO_SIDED|95.0|-0.3|0.9|||ANOVA|||||0.9|-0.3|0.3228
91743499|NCT04855240|183381882|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7617|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.7617
91743500|NCT04855240|183381882|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6241|TWO_SIDED|95.0|-0.4|0.6|||ANOVA|||||0.6|-0.4|0.6241
91743501|NCT04855240|183381883|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3442|TWO_SIDED|95.0|-0.5|0.2|||ANOVA|||||0.2|-0.5|0.3442
91743502|NCT04855240|183381883|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.7896|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.7896
91743503|NCT04855240|183381884|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.6003|TWO_SIDED|95.0|-1.2|0.7|||ANOVA|||||0.7|-1.2|0.6003
91743504|NCT04855240|183381884|SUPERIORITY||LSM difference|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.4086|TWO_SIDED|95.0|-0.6|1.4|||ANOVA|||||1.4|-0.6|0.4086
91743505|NCT04855240|183381885|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4958|TWO_SIDED|95.0|-1.6|0.8|||ANOVA|||||0.8|-1.6|0.4958
91743506|NCT04855240|183381885|SUPERIORITY||LSM difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4595|TWO_SIDED|95.0|-0.8|1.7|||ANOVA|||||1.7|-0.8|0.4595
91500559|NCT04249310|182870949|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.15|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate or Severe COPD Exacerbation||1.15|0.63|
91500560|NCT04249310|182870949|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.43|1.01|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate COPD Exacerbation||1.01|0.43|
91743507|NCT04855240|183381886|SUPERIORITY||Risk Difference (RD)|0.08||||0.1686|TWO_SIDED|95.0|-0.04|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.04|0.1686
91500561|NCT04249310|182870949|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.31|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Severe COPD Exacerbation||1.31|0.62|
91743508|NCT04855240|183381886|SUPERIORITY||Risk Difference (RD)|0.0||||0.8333|TWO_SIDED|95.0|-0.1|0.11|||Cochran-Mantel-Haenszel|||||0.11|-0.10|0.8333
91743509|NCT04855240|183381887|SUPERIORITY||Risk Difference (RD)|0.09||||0.1939|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1939
91743510|NCT04855240|183381887|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
91743511|NCT04855240|183381888|SUPERIORITY||Risk Difference (RD)|0.09||||0.1894|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1894
91743512|NCT04855240|183381888|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
91743513|NCT04855240|183381889|SUPERIORITY||Risk Difference (RD)|0.09||||0.7117|TWO_SIDED|95.0|-0.06|0.24|||Cochran-Mantel-Haenszel|||||0.24|-0.06|0.7117
91743514|NCT04855240|183381889|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7599|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.7599
91743515|NCT04855240|183381890|SUPERIORITY||Risk Difference (RD)|0.0||||0.707|TWO_SIDED|95.0|-0.16|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.16|0.7070
91743516|NCT04855240|183381890|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6877|TWO_SIDED|95.0|-0.2|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.20|0.6877
91743517|NCT04855240|183381891|SUPERIORITY||Risk Difference (RD)|-0.07||||0.869|TWO_SIDED|95.0|-0.22|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.22|0.8690
91743518|NCT04855240|183381891|SUPERIORITY||Risk Difference (RD)|-0.04||||0.379|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.3790
91743519|NCT04855240|183381892|SUPERIORITY||LSM difference|5.9|STANDARD_ERROR_OF_MEAN|3.49||0.0897|TWO_SIDED|95.0|-0.9|12.8|||ANOVA|||||12.8|-0.9|0.0897
91743520|NCT04855240|183381892|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5||0.9434|TWO_SIDED|95.0|-7.1|6.7|||ANOVA|||||6.7|-7.1|0.9434
91743521|NCT04855240|183381893|SUPERIORITY||Risk Difference (RD)|0.09||||0.8355|TWO_SIDED|95.0|-0.04|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.04|0.8355
91743522|NCT04855240|183381893|SUPERIORITY||Risk Difference (RD)|0.02||||0.3561|TWO_SIDED|95.0|-0.12|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.12|0.3561
91743523|NCT04855240|183381894|SUPERIORITY||Risk Difference (RD)|0.04||||0.9413|TWO_SIDED|95.0|-0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.06|0.9413
91743524|NCT04855240|183381894|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7819|TWO_SIDED|95.0|-0.15|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.15|0.7819
91743525|NCT04855240|183381895|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.8461|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.8461
91743526|NCT04855240|183381895|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
91743527|NCT04855240|183381896|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9022|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.9022
91743528|NCT04855240|183381896|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.245|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2450
91743529|NCT04855240|183381897|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.4205||0.4205|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4205
91743530|NCT04855240|183381897|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4336|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4336
91743531|NCT04855240|183381898|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2718|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2718
91743532|NCT04855240|183381898|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
91743533|NCT00244725|183381910|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45||||0.012|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.012
91743534|NCT00244725|183381910|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.42||||0.017|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.017
91743535|NCT00244725|183381910|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.32||||0.08|TWO_SIDED|95.0|1.0|1.8|||Fisher Exact|||||1.8|1.0|0.080
91500562|NCT01119131|182870969|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||ANOVA|||||||0.699
91500563|NCT01119131|182870970|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||ANOVA|||||||0.308
91743536|NCT04004221|183381924|OTHER||||||<|0.0001|||||||Exact Binomial Test|1-sided p-value was based on binomial exact test of Tislelizumab versus historical rate of 0.1||||||< 0.0001
91743537|NCT03423238|183381937|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||Baseline||||0.388
91743538|NCT03423238|183381938|SUPERIORITY|||||||0.017|||||||ANCOVA|||Month 3||||0.017
91743539|NCT03423238|183381938|SUPERIORITY|||||||0.002|||||||ANCOVA|||Month 6||||0.002
91743540|NCT03423238|183381939|SUPERIORITY|||||||0.653|||||||t-test, 2 sided|||Baseline||||0.653
91743541|NCT03423238|183381940|SUPERIORITY|||||||0.684|||||||ANCOVA|||Month 3||||0.684
91743542|NCT03423238|183381940|SUPERIORITY|||||||0.458|||||||ANCOVA|||Month 6||||0.458
91743543|NCT03423238|183381941|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Baseline||||0.550
91743544|NCT03423238|183381942|SUPERIORITY|||||||0.973|||||||ANCOVA|||Month 3||||0.973
91743545|NCT03423238|183381942|SUPERIORITY|||||||0.432|||||||ANCOVA|||Month 6||||0.432
91743546|NCT03423238|183381943|SUPERIORITY|||||||0.23063|||||||t-test, 2 sided|||Baseline||||0.23063
91743547|NCT03423238|183381944|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
91743548|NCT03423238|183381944|SUPERIORITY|||||||0.874|||||||ANCOVA|||Month 6||||0.874
91743549|NCT03423238|183381945|SUPERIORITY|||||||0.563|||||||t-test, 2 sided|||Baseline||||0.563
91743550|NCT03423238|183381946|SUPERIORITY|||||||0.008|||||||ANCOVA|||Month 3||||0.008
91743551|NCT03423238|183381946|SUPERIORITY|||||||0.922|||||||ANCOVA|||Month 6||||0.922
91743552|NCT03423238|183381947|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||Baseline||||0.667
91743553|NCT03423238|183381948|SUPERIORITY|||||||0.692|||||||ANCOVA|||Month 3||||0.692
91743554|NCT03423238|183381948|SUPERIORITY|||||||0.59|||||||ANCOVA|||Month 6||||0.590
91743555|NCT03423238|183381949|SUPERIORITY|||||||0.844|||||||t-test, 2 sided|||Baseline||||0.844
91743556|NCT03423238|183381950|SUPERIORITY|||||||0.721|||||||ANCOVA|||Month 3||||0.721
91743557|NCT03423238|183381950|SUPERIORITY|||||||0.851|||||||ANCOVA|||Month 6||||0.851
91500564|NCT01119131|182870971|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||ANOVA|||||||0.419
91743558|NCT03423238|183381951|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||Baseline||||0.815
91743559|NCT03423238|183381952|SUPERIORITY|||||||0.488|||||||ANCOVA|||Month 3||||0.488
91743560|NCT03423238|183381952|SUPERIORITY|||||||0.237|||||||ANCOVA|||Month 6||||0.237
91743561|NCT03423238|183381953|SUPERIORITY|||||||0.506|||||||t-test, 2 sided|||||||0.506
91743562|NCT03423238|183381954|SUPERIORITY|||||||0.549|||||||ANCOVA|||Month 3||||0.549
91743563|NCT03423238|183381954|SUPERIORITY|||||||0.303|||||||ANCOVA|||Month 6||||0.303
91743564|NCT03423238|183381955|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||Baseline||||0.934
91743565|NCT03423238|183381956|SUPERIORITY|||||||0.792|||||||ANCOVA|||Month 3||||0.792
91743566|NCT03423238|183381956|SUPERIORITY|||||||0.417|||||||ANCOVA|||Month 6||||0.417
91743567|NCT03423238|183381957|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Baseline||||0.685
91743568|NCT03423238|183381958|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
91743569|NCT03423238|183381958|SUPERIORITY|||||||0.903|||||||ANCOVA|||Month 6||||0.903
91743570|NCT03423238|183381959|SUPERIORITY|||||||0.569|||||||t-test, 2 sided|||Baseline||||0.569
91743571|NCT03423238|183381960|SUPERIORITY|||||||0.824|||||||ANCOVA|||Month 3||||0.824
91743572|NCT03423238|183381960|SUPERIORITY|||||||0.401|||||||ANCOVA|||Month 6||||0.401
91743573|NCT03423238|183381961|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Baseline||||0.188
91743574|NCT03423238|183381962|SUPERIORITY|||||||0.338|||||||ANCOVA|||Month 3||||0.338
91743575|NCT03423238|183381962|SUPERIORITY|||||||0.484|||||||ANCOVA|||Month 6||||0.484
91500565|NCT01119131|182870972|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED||||||ANOVA|||||||0.253
91500566|NCT01119131|182870973|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED||||||ANOVA|||||||0.793
91500567|NCT01119131|182870975|SUPERIORITY_OR_OTHER|||||||0.949|TWO_SIDED||||||ANOVA|||||||0.949
91500568|NCT01119131|182870976|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||||||0.957
91500569|NCT00459667|182870989|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|17.4||||||95.0|14.4|20.7||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||20.7|14.4|
91743576|NCT03423238|183381963|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||Baseline||||0.533
91743577|NCT03423238|183381964|SUPERIORITY|||||||0.992|||||||ANCOVA|||Month 3||||0.992
91743578|NCT03423238|183381964|SUPERIORITY|||||||0.639|||||||ANCOVA|||Month 6||||0.639
91743579|NCT03745638|183381973|SUPERIORITY||Odds Ratio (OR)|6.38|||<|0.0001|TWO_SIDED|95.0|3.556|11.923||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||11.923|3.556|< 0.0001
91743580|NCT03745638|183381973|SUPERIORITY||Odds Ratio (OR)|7.5|||<|0.0001|TWO_SIDED|95.0|4.178|14.04||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||14.040|4.178|< 0.0001
91743581|NCT03745638|183381974|SUPERIORITY||Odds Ratio (OR)|4.04|||<|0.0001|TWO_SIDED|95.0|2.441|6.808||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.808|2.441|< 0.0001
91743582|NCT03745638|183381974|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.0001|TWO_SIDED|95.0|3.145|8.831||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.831|3.145|< 0.0001
91743583|NCT03745638|183381975|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0002|TWO_SIDED|95.0|1.773|8.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.083|1.773|0.0002
91743584|NCT03745638|183381975|SUPERIORITY||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|2.931|13.22||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.220|2.931|< 0.0001
91743585|NCT03745638|183381976|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0081|TWO_SIDED|95.0|1.242|5.723||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||5.723|1.242|0.0081
91743586|NCT03745638|183381976|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0039|TWO_SIDED|95.0|1.334|6.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.083|1.334|0.0039
91743587|NCT03745638|183381977|SUPERIORITY||Odds Ratio (OR)|1.67||||0.1421|TWO_SIDED|95.0|0.862|3.391||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.391|0.862|0.1421
91743588|NCT03745638|183381977|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0746|TWO_SIDED|95.0|0.949|3.665||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.665|0.949|0.0746
91743589|NCT03745638|183381987|SUPERIORITY||Least Squares Mean Difference|-35.48|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-43.64|-27.32|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-27.32|-43.64|< 0.0001
91743590|NCT03745638|183381987|SUPERIORITY||Least Squares Method of Mean Difference]|-40.29|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|-48.44|-32.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-32.13|-48.44|< 0.0001
91743591|NCT03745638|183381987|SUPERIORITY||Least Squares Mean Difference|-45.01|STANDARD_ERROR_OF_MEAN|4.72|<|0.0001|TWO_SIDED|95.0|-54.28|-35.74|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.74|-54.28|< 0.0001
91743592|NCT03745638|183381987|SUPERIORITY||Least Squares Mean Difference|-48.05|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.3|-38.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-38.79|-57.30|< 0.0001
91743593|NCT03745638|183381987|SUPERIORITY||Least Squares Mean Difference|-33.13|STANDARD_ERROR_OF_MEAN|4.49|<|0.0001|TWO_SIDED|95.0|-41.95|-24.3||The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.|Mixed-Model with Repeated Measures|||Percent change from Baseline in EASI score at Week 8||-24.30|-41.95|< 0.0001
91743594|NCT03745638|183381987|SUPERIORITY||Least Squares Mean Difference|-39.52|STANDARD_ERROR_OF_MEAN|4.48|<|0.0001|TWO_SIDED|95.0|-48.32|-30.72|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-30.72|-48.32|< 0.0001
91743595|NCT03745638|183381988|SUPERIORITY||Least Squares Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-32.62|-17.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-17.95|-32.62|< 0.0001
91743596|NCT03745638|183381988|SUPERIORITY||Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-37.68|-23.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-23.06|-37.68|< 0.0001
91743597|NCT03745638|183381989|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.87|-0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-0.91|-1.87|<0.0001
91743598|NCT03745638|183381989|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.11|-1.16|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.16|-2.11|<0.0001
91743599|NCT03745638|183381989|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.25|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.15|-2.25|<0.0001
91743600|NCT03745638|183381989|SUPERIORITY||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.63|-1.53|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.53|-2.63|<0.0001
91743601|NCT03745638|183381989|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.01|-2.20|<0.0001
91743602|NCT03745638|183381989|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.58|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.40|-2.58|<0.0001
91743603|NCT03745638|183381991|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.74|-0.74|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.74|-1.74|<0.0001
91500570|NCT00459667|182870989|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|15.8||||||95.0|13.1|18.9||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||18.9|13.1|
91500571|NCT00459667|182870989|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|31.1||||||95.0|24.4|38.4||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||38.4|24.4|
91500572|NCT00459667|182870990|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|28.0|35.7||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||35.7|28.0|
91500573|NCT00459667|182870990|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|26.2||||||95.0|22.8|29.8||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||29.8|22.8|
91500574|NCT00459667|182870990|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|24.9|39.0||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||39.0|24.9|
91500575|NCT00556712|182871001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.82|||Log Rank|||||0.82|0.62|<0.0001
91500576|NCT00556712|182871005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0097|TWO_SIDED|95.0|0.72|0.96|||Log Rank|||||0.96|0.72|0.0097
91500577|NCT00556712|182871008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.005|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0050
91500578|NCT00556712|182871011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.1768|TWO_SIDED|95.0|0.51|1.14|||Log Rank|||||1.14|0.51|0.1768
91500579|NCT00556712|182871014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4797|TWO_SIDED|95.0|0.49|1.4|||Log Rank|||||1.40|0.49|0.4797
91500580|NCT00556712|182871016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||Log Rank|||||0.82|0.61|<0.0001
91500581|NCT00556712|182871018|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.53||||0.0006|TWO_SIDED|95.0|2.7|10.3|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||10.3|2.7|0.0006
91500582|NCT00556712|182871020|SUPERIORITY_OR_OTHER||Difference in Response Upgrade Rates|4.2||||0.0007|TWO_SIDED|95.0|1.6|6.7|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||6.7|1.6|0.0007
91500583|NCT00556712|182871022|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|9.8||||0.0035|TWO_SIDED|95.0|3.1|16.4|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD rate.||16.4|3.1|0.0035
91500584|NCT00556712|182871022|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|13.4|||<|0.0001|TWO_SIDED|95.0|7.1|19.7|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD \> 12 weeks rate.||19.7|7.1|<0.0001
91500585|NCT00556712|182871024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.3787|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||||1.12|0.74|0.3787
91500586|NCT00556712|182871026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|< 0.0001
91500587|NCT00556712|182871029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5385|TWO_SIDED|95.0|0.87|1.31|||Log Rank|||||1.31|0.87|0.5385
91500588|NCT00556712|182871032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.653|TWO_SIDED|95.0|0.79|1.16|||Log Rank|||||1.16|0.79|0.6530
91500589|NCT00818662|182871048|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.8||||0.476||95.0|-3.1|1.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||1.5|-3.1|0.476
91500590|NCT00818662|182871048|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.53||95.0|-1.6|3.0|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.0|-1.6|0.530
91500591|NCT00818662|182871049|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.812||95.0|-2.9|3.7|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.7|-2.9|0.812
91500592|NCT00818662|182871049|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.9||||0.602||95.0|-4.3|2.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||2.5|-4.3|0.602
91500593|NCT00818662|182871050|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.7||||0.368||95.0|-2.3|0.8|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||0.8|-2.3|0.368
91500594|NCT00818662|182871050|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.8||||0.319||95.0|-0.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||2.4|-0.8|0.319
91500595|NCT00818662|182871051|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.778||95.0|-1.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||2.4|-1.8|0.778
91500596|NCT00818662|182871051|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.851||95.0|-2.3|1.9|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||1.9|-2.3|0.851
91500597|NCT00818662|182871052|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.306||95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|0.306
91743604|NCT03745638|183381991|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.11|-1.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-1.13|-2.11|<0.0001
91743605|NCT03745638|183381994|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.54||0.0049|TWO_SIDED|95.0|-2.6|-0.47|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-0.47|-2.60|0.0049
91743606|NCT03745638|183381994|SUPERIORITY||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.37|-1.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-1.25|-3.37|<0.0001
91743607|NCT03745638|183381994|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.6||0.0001|TWO_SIDED|95.0|-3.52|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.15|-3.52|0.0001
91743608|NCT03745638|183381994|SUPERIORITY||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.03|-1.67|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.67|-4.03|<0.0001
91743609|NCT03745638|183381994|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.71||0.0004|TWO_SIDED|95.0|-3.93|-1.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.14|-3.93|0.0004
91743610|NCT03745638|183381994|SUPERIORITY||Least Squares Mean Difference|-3.18|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-4.57|-1.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.79|-4.57|<0.0001
91743611|NCT03745638|183381995|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.6||0.0487|TWO_SIDED|95.0|-2.35|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.35|0.0487
91743612|NCT03745638|183381995|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.59||0.0049|TWO_SIDED|95.0|-2.84|-0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.51|-2.84|0.0049
91743613|NCT03745638|183381995|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.66||0.0128|TWO_SIDED|95.0|-2.94|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.94|0.0128
91743614|NCT03745638|183381995|SUPERIORITY||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.66||0.0037|TWO_SIDED|95.0|-3.2|-0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.62|-3.20|0.0037
91743615|NCT03745638|183381995|SUPERIORITY||Least Squares Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.75||0.0048|TWO_SIDED|95.0|-3.58|-0.65|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.65|-3.58|0.0048
91743616|NCT03745638|183381995|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.74||0.002|TWO_SIDED|95.0|-3.75|-0.84|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.84|-3.75|0.0020
91743617|NCT03745638|183381998|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.07|-2.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.18|-4.07|<0.0001
91743618|NCT03745638|183381998|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.67|-2.79|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.79|-4.67|<0.0001
91743619|NCT03745638|183382000|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-6.43|-3.8|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-3.80|-6.43|<0.0001
91743620|NCT03745638|183382000|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-7.62|-5.0|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-5.00|-7.62|<0.0001
91743621|NCT03745638|183382002|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.85|-2.68|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.68|-4.85|<0.0001
91743622|NCT03745638|183382002|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-5.56|-3.42|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-3.42|-5.56|<0.0001
91743623|NCT03745638|183382004|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.01||0.0018|TWO_SIDED|95.0|-5.29|-1.26|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.26|-5.29|0.0018
91743624|NCT03745638|183382004|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0378|TWO_SIDED|95.0|-4.43|-0.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-0.13|-4.43|0.0378
91743625|NCT03745638|183382008|SUPERIORITY||Odds Ratio (OR)|6.28|||<|0.0001|TWO_SIDED|95.0|3.632|11.018||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||11.018|3.632|<0.0001
91743626|NCT03745638|183382008|SUPERIORITY||Odds Ratio (OR)|8.39|||<|0.0001|TWO_SIDED|95.0|4.755|15.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||15.083|4.755|<0.0001
91743627|NCT03745638|183382009|SUPERIORITY||Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|1.67||0.0037|TWO_SIDED|95.0|1.59|8.15|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.15|1.59|0.0037
91743628|NCT03745638|183382009|SUPERIORITY||Least Squares Mean Difference|5.7|STANDARD_ERROR_OF_MEAN|1.66||0.0006|TWO_SIDED|95.0|2.45|8.96|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.96|2.45|0.0006
91743629|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.34||0.1417|TWO_SIDED|95.0|-11.49|1.65|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.65|-11.49|0.1417
91743630|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|3.29||0.6037|TWO_SIDED|95.0|-8.19|4.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||4.77|-8.19|0.6037
91743631|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.99||0.0003|TWO_SIDED|95.0|-16.89|-5.12|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.12|-16.89|0.0003
91743632|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|2.93|<|0.0001|TWO_SIDED|95.0|-17.98|-6.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.47|-17.98|<0.0001
91743633|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|3.85|<|0.0001|TWO_SIDED|95.0|-22.95|-7.81|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.81|-22.95|<0.0001
91743634|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0011|TWO_SIDED|95.0|-19.85|-5.01|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.01|-19.85|0.0011
91743635|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|-14.64|-6.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.29|-14.64|<0.0001
91743636|NCT03745638|183382010|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|-16.6|-8.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-8.29|-16.60|<0.0001
91760154|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-1.08|4.65||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.65|-1.08|
91760155|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|||||TWO_SIDED|95.0|1.52|7.28||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.28|1.52|
91760156|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2|||||TWO_SIDED|95.0|3.33|9.07||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.07|3.33|
91760157|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|0.85|6.55||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.55|0.85|
91500598|NCT00818662|182871052|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.028||95.0|0.0|0.5|||Mixed Models Analysis|||||0.5|0.0|0.028
91743637|NCT02993822|183382042|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.324|TWO_SIDED|95.0|0.88|1.49|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.49|0.88|0.324
91743638|NCT02993822|183382042|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.332|TWO_SIDED|95.0|0.88|1.48|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.48|0.88|0.332
91743639|NCT02993822|183382042|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.531|TWO_SIDED|95.0|0.71|1.2|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.20|0.71|0.531
91743640|NCT02993822|183382043|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.482|TWO_SIDED|95.0|0.75|1.15|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.15|0.75|0.482
91743641|NCT02993822|183382043|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.46|TWO_SIDED|95.0|0.75|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.75|0.460
91743642|NCT02993822|183382043|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.144|TWO_SIDED|95.0|0.69|1.06|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.06|0.69|0.144
91743643|NCT02993822|183382044|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.992|TWO_SIDED|95.0|0.78|1.27|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.27|0.78|0.992
91743644|NCT02993822|183382044|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.387|TWO_SIDED|95.0|0.71|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.71|0.387
91743645|NCT02993822|183382044|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.6|TWO_SIDED|95.0|0.74|1.19|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.19|0.74|0.600
91743646|NCT02993822|183382045|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.042|TWO_SIDED|95.0|0.0|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.0|0.042
91500599|NCT00818662|182871053|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.66||95.0|-0.3|0.2|||Mixed Models Analysis|||||0.2|-0.3|0.660
91500600|NCT00818662|182871053|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.766||95.0|-0.2|0.3|||Mixed Models Analysis|||||0.3|-0.2|0.766
91743647|NCT02993822|183382045|SUPERIORITY||Median Difference (Final Values)|1.1||||0.026|TWO_SIDED|95.0|0.1|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.1|0.026
91743648|NCT02993822|183382045|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.003|TWO_SIDED|95.0|0.5|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.5|0.003
91743649|NCT02993822|183382046|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.25|TWO_SIDED|95.0|-0.4|1.7|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.7|-0.4|0.250
91743650|NCT02993822|183382046|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.5|1.5|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.5|-0.5|0.325
91743651|NCT02993822|183382046|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.029|TWO_SIDED|95.0|0.1|2.2|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.2|0.1|0.029
91743652|NCT02993822|183382047|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.038|TWO_SIDED|95.0|0.1|2.3|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.3|0.1|0.038
91743653|NCT02993822|183382047|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.118|TWO_SIDED|95.0|-0.2|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|-0.2|0.118
91743654|NCT02993822|183382047|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.025|TWO_SIDED|95.0|0.2|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.2|0.025
91743655|NCT02993822|183382048|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.9|-0.5|0.258
91743656|NCT02993822|183382048|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.243|TWO_SIDED|95.0|-0.5|1.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.8|-0.5|0.243
91743657|NCT02993822|183382048|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.009|TWO_SIDED|95.0|0.4|2.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.8|0.4|0.009
91743658|NCT02993822|183382049|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.008|TWO_SIDED|95.0|-16.6|-2.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-2.5|-16.6|0.008
91743659|NCT02993822|183382049|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.198|TWO_SIDED|95.0|-11.4|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-11.4|0.198
91743660|NCT02993822|183382049|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.055|TWO_SIDED|95.0|-13.7|0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.1|-13.7|0.055
91743661|NCT02993822|183382050|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.026|TWO_SIDED|95.0|-16.3|-1.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.1|-16.3|0.026
91500601|NCT00818662|182871054|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.9||||0.206||95.0|-1.0|4.8|||ANCOVA|||||4.8|-1.0|0.206
91743662|NCT02993822|183382050|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.571|TWO_SIDED|95.0|-9.6|5.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.3|-9.6|0.571
91743663|NCT02993822|183382050|SUPERIORITY||Mean Difference (Final Values)|-7.7||||0.043|TWO_SIDED|95.0|-15.2|-0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.3|-15.2|0.043
91743664|NCT02993822|183382051|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.006|TWO_SIDED|95.0|-19.7|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-19.7|0.006
91743665|NCT02993822|183382051|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.435|TWO_SIDED|95.0|-11.1|4.8|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.8|-11.1|0.435
91743666|NCT02993822|183382051|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.022|TWO_SIDED|95.0|-17.4|-1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.4|-17.4|0.022
91743667|NCT02993822|183382052|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.103|TWO_SIDED|95.0|-15.3|1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||1.4|-15.3|0.103
91743668|NCT02993822|183382052|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.546|TWO_SIDED|95.0|-10.6|5.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.6|-10.6|0.546
91743669|NCT02993822|183382052|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.034|TWO_SIDED|95.0|-17.2|-0.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.7|-17.2|0.034
91743670|NCT02993822|183382053|SUPERIORITY||Mean Difference (Final Values)|-11.2||||0.004|TWO_SIDED|95.0|-18.8|-3.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.6|-18.8|0.004
91743671|NCT02993822|183382053|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.282|TWO_SIDED|95.0|-11.5|3.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.4|-11.5|0.282
91743672|NCT02993822|183382053|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.398|TWO_SIDED|95.0|-10.7|4.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.3|-10.7|0.398
91500602|NCT00818662|182871054|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.4||||0.331||95.0|-4.3|1.5|||ANCOVA|||||1.5|-4.3|0.331
91500603|NCT00818662|182871055|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.64||95.0|-2.1|3.4|||ANCOVA|||||3.4|-2.1|0.640
91743673|NCT02993822|183382054|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.019|TWO_SIDED|95.0|-18.3|-1.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.7|-18.3|0.019
91500604|NCT00818662|182871055|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|2.5||||0.075||95.0|-0.3|5.3|||ANCOVA|||||5.3|-0.3|0.075
91500605|NCT00818662|182871056|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.093||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.093
91500606|NCT00818662|182871056|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.094||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.094
91500607|NCT00818662|182871057|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.096||95.0|-2.3|0.2|||ANCOVA|||||0.2|-2.3|0.096
91500608|NCT00818662|182871057|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.0||||0.123||95.0|-2.2|0.3|||ANCOVA|||||0.3|-2.2|0.123
91500609|NCT00818662|182871058|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.167||95.0|-0.2|1.0|||ANCOVA|||||1.0|-0.2|0.167
91500610|NCT00818662|182871058|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.998||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.998
91500611|NCT00818662|182871059|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.173||95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.173
91500612|NCT00818662|182871059|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.744||95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.744
91743674|NCT02993822|183382054|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.17|TWO_SIDED|95.0|-13.7|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-13.7|0.170
91500613|NCT00818662|182871060|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.5||||0.238||95.0|-1.0|4.0|||ANCOVA|||||4.0|-1.0|0.238
91743675|NCT02993822|183382054|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.384|TWO_SIDED|95.0|-11.7|4.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.5|-11.7|0.384
91743676|NCT02993822|183382055|SUPERIORITY||Mean Difference (Final Values)|-11.7||||0.006|TWO_SIDED|95.0|-20.0|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-20.0|0.006
91500614|NCT00818662|182871060|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.4||95.0|-3.6|1.4|||ANCOVA|||||1.4|-3.6|0.400
91500615|NCT00818662|182871061|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.6||||0.695||95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.695
91500616|NCT00818662|182871061|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.3||||0.41||95.0|-4.5|1.9|||ANCOVA|||||1.9|-4.5|0.410
91500617|NCT00818662|182871062|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.988||95.0|-1.5|1.5|||ANCOVA|||||1.5|-1.5|0.988
91500618|NCT00818662|182871062|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.555||95.0|-1.0|1.9|||ANCOVA|||||1.9|-1.0|0.555
91500619|NCT00818662|182871063|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.5||||0.783||95.0|-12.2|9.2|||ANCOVA|||||9.2|-12.2|0.783
91500620|NCT00818662|182871063|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-2.1||||0.7||95.0|-13.1|8.8|||ANCOVA|||||8.8|-13.1|0.700
91500621|NCT00818662|182871064|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-15.2||||0.191||95.0|-38.0|7.7|||ANCOVA|||||7.7|-38.0|0.191
91500622|NCT00818662|182871064|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.6||||0.892||95.0|-25.4|22.1|||ANCOVA|||||22.1|-25.4|0.892
91500623|NCT00818662|182871065|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.588||95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.588
91500624|NCT00818662|182871065|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.351||95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.351
91500625|NCT01722071|182871078|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.890
91743677|NCT02993822|183382055|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.222|TWO_SIDED|95.0|-13.0|3.0|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.0|-13.0|0.222
91743678|NCT02993822|183382055|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.058|TWO_SIDED|95.0|-16.0|0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.3|-16.0|0.058
91743679|NCT02993822|183382056|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.027|TWO_SIDED|95.0|-18.9|-1.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.2|-18.9|0.027
91743680|NCT02993822|183382056|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.147|TWO_SIDED|95.0|-14.9|2.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.2|-14.9|0.147
91743681|NCT02993822|183382056|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.046|TWO_SIDED|95.0|-17.6|-0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.1|-17.6|0.046
91743682|NCT02993822|183382057|SUPERIORITY||Mean Difference (Final Values)|-12.5|||<|0.001|TWO_SIDED|95.0|-19.5|-5.5|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-5.5|-19.5|<0.001
91743683|NCT02993822|183382057|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.114|TWO_SIDED|95.0|-12.4|1.3|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||1.3|-12.4|0.114
91743684|NCT02993822|183382057|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.056|TWO_SIDED|95.0|-13.7|0.2|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||0.2|-13.7|0.056
91743685|NCT02993822|183382058|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.027|TWO_SIDED|95.0|-16.8|-1.0|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.0|-16.8|0.027
91743686|NCT02993822|183382058|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.357|TWO_SIDED|95.0|-11.3|4.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||4.1|-11.3|0.357
91743687|NCT02993822|183382058|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.031|TWO_SIDED|95.0|-16.2|-0.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.8|-16.2|0.031
91743688|NCT02993822|183382059|SUPERIORITY||Mean Difference (Final Values)|-11.1||||0.008|TWO_SIDED|95.0|-19.2|-2.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-2.9|-19.2|0.008
91743689|NCT02993822|183382059|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.321|TWO_SIDED|95.0|-11.8|3.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||3.9|-11.8|0.321
91743690|NCT02993822|183382059|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.047|TWO_SIDED|95.0|-16.0|-0.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.1|-16.0|0.047
91743691|NCT02993822|183382060|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.018|TWO_SIDED|95.0|-18.4|-1.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.8|-18.4|0.018
91743692|NCT02993822|183382060|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.682|TWO_SIDED|95.0|-9.8|6.4|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||6.4|-9.8|0.682
91743693|NCT02993822|183382060|SUPERIORITY||Mean Difference (Final Values)|-11.8||||0.005|TWO_SIDED|95.0|-20.0|-3.6|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-3.6|-20.0|0.005
91743694|NCT02993822|183382061|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
91743695|NCT02993822|183382061|SUPERIORITY|||||||0.134|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.134
91743696|NCT02993822|183382061|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
91743697|NCT02993822|183382062|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.401
91743698|NCT02993822|183382062|SUPERIORITY|||||||0.175|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.175
91743699|NCT02993822|183382062|SUPERIORITY|||||||0.126|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.126
91743700|NCT02993822|183382063|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.002
91743701|NCT02993822|183382063|SUPERIORITY|||||||0.144|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.144
91743702|NCT02993822|183382063|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
91743703|NCT02993822|183382064|SUPERIORITY|||||||0.158|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.158
91743704|NCT02993822|183382064|SUPERIORITY|||||||0.597|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.597
91743705|NCT02993822|183382064|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.124
91743706|NCT02993822|183382065|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.01
91743707|NCT02993822|183382065|SUPERIORITY|||||||0.049|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.049
91743708|NCT02993822|183382065|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.001
91743709|NCT02993822|183382066|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.309
91743710|NCT02993822|183382066|SUPERIORITY|||||||0.387|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.387
91743711|NCT02993822|183382066|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
91743712|NCT02993822|183382067|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
91743713|NCT02993822|183382067|SUPERIORITY|||||||0.152|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.152
91743714|NCT02993822|183382067|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
91743715|NCT02993822|183382068|SUPERIORITY|||||||0.1|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.100
91500626|NCT01722071|182871078|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.422
91743716|NCT02993822|183382068|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.557
91743717|NCT02993822|183382068|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.054
91743718|NCT01939977|183382085|SUPERIORITY|||||||0.0083|||||||Chi-squared|||"Taking per protocol population, the percentage of patients with iPTH\> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol"||||0.0083
91743719|NCT03641716|183382107|OTHER||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
91743720|NCT03641716|183382108|OTHER||Effect Size - Cohen's d|-0.01|||||TWO_SIDED|95.0|-0.66|0.65||||||Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.||.65|-.66|
91743721|NCT03641716|183382109|OTHER||||||<|0.01||||||a prior threshold for statistical significance set at p\<.05|t-test, 2 sided|We ran a paired samples t-test with pre/post intervention data (from baseline and 3-month assessments).||After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.||||<.01
91743722|NCT01696981|183382119|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
91743723|NCT01696981|183382121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.85|||Poisson regression|||||0.85|0.72|
91743724|NCT01696981|183382123|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.87|||Poisson regression|||||0.87|0.63|
91743725|NCT00005947|183382150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.052||95.0|0.99|2.11|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].|||2.11|0.99|0.052
91743726|NCT00005947|183382150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.052|TWO_SIDED|95.0|0.47|1.01|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]|||1.01|0.47|0.052
91743727|NCT00005947|183382151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.71||||0.01||95.0|1.13|2.58|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].|ITT Population - all randomized participants||2.58|1.13|0.010
91743728|NCT00005947|183382151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.586||||0.01|TWO_SIDED|95.0|0.388|0.884|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]|ITT Population - all randomized participants.||0.884|0.388|0.010
91743729|NCT00851890|183382161|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.012
91743730|NCT00851890|183382161|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.071
91743731|NCT00851890|183382161|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.140
91743732|NCT00851890|183382162|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.008
91743733|NCT00851890|183382162|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.003
91743734|NCT00851890|183382162|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.009
91743735|NCT00851890|183382169|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.018
91743736|NCT00851890|183382169|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.020
91743737|NCT00851890|183382169|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.054
91743738|NCT00851890|183382169|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.010
91743739|NCT00851890|183382169|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.005
91743740|NCT00851890|183382169|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.014
91743741|NCT00851890|183382170|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
91743742|NCT00851890|183382170|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
91743743|NCT00851890|183382170|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.138
91743744|NCT00851890|183382171|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
91743745|NCT00851890|183382171|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.473
91743746|NCT00851890|183382171|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.031
91743747|NCT00851890|183382172|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
91743748|NCT00851890|183382172|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||1.000
91743749|NCT03135431|183382175|NON_INFERIORITY|\<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.|Mean Difference (Final Values)|-0.04121||||0.08|ONE_SIDED|95.0||0.0712|||t-test, 1 sided|||Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).|Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.|.0712||0.08
91743750|NCT03135431|183382176|SUPERIORITY||Mean Difference (Final Values)|-11.21|||||TWO_SIDED|95.0|-14.1|-8.3|||||Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.|||-8.3|-14.1|
91743751|NCT03135431|183382177|SUPERIORITY||Mean Difference (Net)|-9.17||||0.77|TWO_SIDED|95.0|-72.5|54.17|||t-test, 2 sided|||Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.||54.17|-72.5|0.77
91743752|NCT03122145|183382185|SUPERIORITY|Mann whitney U between groups comparison for voluntary cough parameters between healthy controls and individuals with ALS outcomes: peak expiratory cough flow and cough volume acceleration||||||0.0005|||||||ANOVA|||Hypothesis that voluntary cough \> reflex cough strength and effectiveness in healthy volunteers||||0.0005
91743753|NCT03206918|183382198|SUPERIORITY||2-side Clopper-Pearson|87.9|||<|0.0001|TWO_SIDED|95.0|79.4|93.81|||Exact Binomial Test|The null hypothesis is ORR = 32%||||93.81|79.40|<0.0001
91743754|NCT00475085|183382212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013||||0.718|TWO_SIDED|95.0|-0.225|0.2||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 2 (palonosetron vs. granisetron)||0.200|-0.225|0.718
91743755|NCT00475085|183382212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195||||0.01|TWO_SIDED|95.0|-0.017|0.407||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 4 (adding dexamethasone)||0.407|-0.017|0.010
91743756|NCT00475085|183382212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.557|TWO_SIDED|95.0|-0.236|0.186||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 3 - Group 4 (aprepitant vs. prochlorperazine)||0.186|-0.236|0.557
91743757|NCT06899737|183382219|SUPERIORITY||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|2.56||0.32|TWO_SIDED|95.0|-7.64|2.55|||t-test, 2 sided|||||2.55|-7.64|0.32
91743758|NCT06899737|183382220|SUPERIORITY||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|3.08||0.18|TWO_SIDED|95.0|-1.94|10.3|||t-test, 2 sided|||||10.30|-1.94|0.18
91743759|NCT06899737|183382221|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|95.0|-0.81|1.18|||t-test, 2 sided|||||1.18|-0.81|0.71
91743760|NCT06899737|183382222|SUPERIORITY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.32||0.32|TWO_SIDED|95.0|-0.03|1.24|||t-test, 2 sided|||||1.24|-0.03|0.32
91743761|NCT06899737|183382223|SUPERIORITY||Median Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.44||0.91|TWO_SIDED|95.0|-0.82|0.92|||t-test, 2 sided|||||0.92|-0.82|0.91
91743762|NCT06899737|183382224|SUPERIORITY||Median Difference (Final Values)|0.69||||0.059|TWO_SIDED|95.0|-0.03|1.42|||t-test, 2 sided|||||1.42|-0.03|0.059
91743763|NCT06899737|183382225|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.79|TWO_SIDED|95.0|-0.92|0.71|||t-test, 2 sided|||||0.71|-0.92|0.79
91743764|NCT06899737|183382226|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.33||0.14|TWO_SIDED|95.0|-0.16|1.15|||t-test, 2 sided|||||1.15|-0.16|0.14
91743765|NCT06899737|183382227|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.43||0.42|TWO_SIDED|95.0|-1.19|0.5|||t-test, 2 sided|||||0.50|-1.19|0.42
91743766|NCT06899737|183382228|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.37||0.37|TWO_SIDED|95.0|-0.4|1.07|||t-test, 2 sided|||||1.07|-0.40|0.37
91743767|NCT06899737|183382230|SUPERIORITY||Mean Difference (Final Values)|6.72|STANDARD_ERROR_OF_MEAN|3.42||0.05|TWO_SIDED|95.0|-0.06|13.51|||t-test, 2 sided|||||13.51|-0.06|0.05
91743768|NCT06899737|183382231|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.35||0.23|TWO_SIDED|95.0|-0.26|1.11|||t-test, 2 sided|||||1.11|-0.26|0.23
91743769|NCT06899737|183382232|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.08|TWO_SIDED|95.0|-0.09|1.39|||t-test, 2 sided|||||1.39|-0.09|0.08
91743770|NCT06899737|183382233|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.38||0.11|TWO_SIDED|95.0|-0.15|1.35|||t-test, 2 sided|||||1.35|-0.15|0.11
91743771|NCT06899737|183382234|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.34||0.05|TWO_SIDED|95.0|-0.01|1.36|||t-test, 2 sided|||||1.36|-0.01|0.05
91743772|NCT00375674|183382236|SUPERIORITY||Cox Proportional Hazard|0.761||||0.03|TWO_SIDED|95.0|0.594|0.975|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||Superiority analysis||0.975|0.594|0.030
91743773|NCT00375674|183382237|SUPERIORITY||Cox Proportional Hazard|0.811||||0.077|TWO_SIDED|95.0|0.643|1.023|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group||Superiority analysis||1.023|0.643|0.077
91743774|NCT00375674|183382238|SUPERIORITY||Hazard Ratio (HR)|0.929||||0.661|TWO_SIDED|95.0|0.67|1.289|||Log-rank test|||Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||1.289|0.670|0.661
91743775|NCT00301262|183382260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.13|STANDARD_ERROR_OF_MEAN|3.405|<|0.0001||95.0|11.4|24.86||Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.|ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.||24.86|11.40|<0.0001
91743776|NCT00301262|183382261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|14.761||0.0028||95.0|1.8|8.37|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||8.370|1.800|0.0028
91743777|NCT00301262|183382261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.02|STANDARD_DEVIATION|22.294|<|0.0001||95.0|20.58|31.455|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||31.455|20.580|<0.0001
91743778|NCT00301262|183382262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.656||0.008||95.0|0.47|3.06|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||3.06|0.47|0.0080
91743779|NCT00301262|183382263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|STANDARD_DEVIATION|2.909||0.0051||95.0|0.29|1.585|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.585|0.290|0.0051
91743780|NCT00301262|183382263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|4.013|<|0.0001||95.0|1.812|3.77|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.770|1.812|<0.0001
91743781|NCT00301262|183382264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|0.922||0.0054||95.0|0.78|4.43|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.43|0.78|0.0054
91743782|NCT00301262|183382265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.368||0.4232||95.0|-0.43|1.02|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.02|-0.43|0.4232
91743783|NCT00301262|183382266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.277||0.0156||95.0|0.13|1.22|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.22|0.13|0.0156
91743784|NCT00301262|183382267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.458||0.0096||95.0|0.3|2.11|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||2.11|0.30|0.0096
91743785|NCT00301262|183382268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.359||0.0135||95.0|0.19|1.61|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.61|0.19|0.0135
91743786|NCT00301262|183382269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|4.392||0.0033||95.0|0.051|2.465|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.465|0.0510|0.0033
91743787|NCT00301262|183382269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.22|STANDARD_DEVIATION|6.346|<|0.0001||95.0|3.676|6.772|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||6.772|3.676|<0.0001
91743788|NCT00301262|183382270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.57||0.2581||95.0|-0.149|0.549|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.549|-0.149|0.2581
91743789|NCT00301262|183382270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39|STANDARD_DEVIATION|2.582|<|0.0001||95.0|0.758|2.018|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.018|0.758|<0.0001
91743790|NCT00301262|183382271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18|STANDARD_DEVIATION|1.456||0.2857||95.0|-0.149|0.499|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.499|-0.149|0.2857
91743791|NCT00301262|183382271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.76|STANDARD_DEVIATION|1.706||0.0005||95.0|0.345|1.177|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.177|0.345|0.0005
91743792|NCT00301262|183382272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|2.548||0.0102||95.0|0.183|1.317|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.317|0.183|0.0102
91743793|NCT00301262|183382272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|2.979|<|0.0001||95.0|1.557|3.01|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.010|1.557|<0.0001
91743794|NCT00301262|183382273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.847||0.0016||95.0|0.264|1.086|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.086|0.264|0.0016
91743795|NCT00301262|183382273|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.9|STANDARD_DEVIATION|2.297|<|0.0001||95.0|1.335|2.456|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.456|1.335|<0.0001
91743796|NCT00301262|183382274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|1.038||0.0083||95.0|0.73|4.83|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.83|0.73|0.0083
91743797|NCT00301262|183382275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|5.193||0.9146||95.0|-1.218|1.093|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.093|-1.218|0.9146
91743798|NCT00301262|183382275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.54|STANDARD_DEVIATION|6.463|<|0.0001||95.0|3.961|7.114|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||7.114|3.961|<0.0001
91743799|NCT00301262|183382276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.42|STANDARD_ERROR_OF_MEAN|4.826||0.0002||95.0|8.88|27.96|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||27.96|8.88|0.0002
91743800|NCT00301262|183382277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.41|STANDARD_DEVIATION|20.444||0.0064||95.0|1.857|10.956|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||10.956|1.857|0.0064
91743801|NCT00301262|183382277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.8|STANDARD_DEVIATION|29.384|<|0.0001|TWO_SIDED|95.0|19.636|33.971|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||33.971|19.636|<0.0001
91743802|NCT00301262|183382278|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.491||||0.0001||95.0|3.042|13.851|||Regression, Logistic|||||13.851|3.042|0.0001
91743803|NCT00301262|183382279|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.915|||<|0.0001||95.0|2.396|10.08|||Regression, Logistic|||||10.080|2.396|<0.0001
91743804|NCT00301262|183382280|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.676||||0.0187||95.0|1.242|10.875|||Regression, Logistic|||||10.875|1.242|0.0187
91743805|NCT00301262|183382281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.9|STANDARD_ERROR_OF_MEAN|4.716||0.0037||95.0|4.59|23.22|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.22|4.59|0.0037
91743806|NCT00301262|183382282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.72|STANDARD_ERROR_OF_MEAN|4.496||0.0321||95.0|0.84|18.6|||independent-samples t-test||Mean Difference = Week 8 - Baseline|||18.60|0.84|0.0321
91743807|NCT00301262|183382283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.97|STANDARD_ERROR_OF_MEAN|3.901||0.0427||95.0|-15.68|-0.27|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-0.27|-15.68|0.0427
91743808|NCT00301262|183382284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|3.903||0.0533||95.0|-15.32|0.11|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.11|-15.32|0.0533
91743809|NCT00301262|183382285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.167|STANDARD_ERROR_OF_MEAN|0.3041||0.0002||95.0|0.566|1.768|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.768|0.566|0.0002
91743810|NCT00301262|183382286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4454|STANDARD_ERROR_OF_MEAN|0.3638||0.0001||95.0|0.727|2.164|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||2.164|0.727|0.0001
91743811|NCT00301262|183382287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1821|STANDARD_ERROR_OF_MEAN|0.3946||0.0032||95.0|0.403|1.961|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.961|0.403|0.0032
91743812|NCT00301262|183382288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2123|STANDARD_ERROR_OF_MEAN|0.3549||0.0008||95.0|0.511|1.913|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.913|0.511|0.0008
91743813|NCT00301262|183382289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.454||0.0195||95.0|0.064|0.711|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.711|0.064|0.0195
91743814|NCT00301262|183382289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.09|STANDARD_DEVIATION|2.207|<|0.0001||95.0|1.551|2.628|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.628|1.551|<0.0001
91743815|NCT00301262|183382290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.489||0.0186||95.0|0.069|0.731|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.731|0.069|0.0186
91743816|NCT00301262|183382290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.67|STANDARD_DEVIATION|2.573|<|0.0001||95.0|2.044|3.299|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.299|2.044|<0.0001
91743817|NCT00301262|183382291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_DEVIATION|1.917||0.0033||95.0|0.223|1.077|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.077|0.223|0.0033
91743818|NCT00301262|183382291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.61|STANDARD_DEVIATION|2.335|<|0.0001||95.0|2.042|3.182|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.182|2.042|<0.0001
91743819|NCT00301262|183382292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.45|STANDARD_DEVIATION|1.606||0.0143||95.0|0.093|0.807|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.807|0.093|0.0143
91743820|NCT00301262|183382292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.99|STANDARD_DEVIATION|2.178|<|0.0001||95.0|1.454|2.516|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.516|1.454|<0.0001
91743821|NCT00301262|183382293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0325
91743822|NCT00301262|183382293|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
91743823|NCT00301262|183382294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0196
91743824|NCT00301262|183382294|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
91743825|NCT00301262|183382295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.3173
91743826|NCT00301262|183382295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0016
91743827|NCT00301262|183382296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.55|STANDARD_ERROR_OF_MEAN|2.958||0.0624||95.0|-11.39|0.29|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.29|-11.39|0.0624
91743828|NCT00301262|183382296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|1.835||0.4523||95.0|-2.24|5.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.01|-2.24|0.4523
91743829|NCT00301262|183382297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.48|STANDARD_ERROR_OF_MEAN|1.962||0.2081||95.0|-6.35|1.4|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.40|-6.35|0.2081
91743830|NCT00301262|183382297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|1.958||0.4131||95.0|-2.26|5.48|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.48|-2.26|0.4131
91743831|NCT00301262|183382298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|2.126||0.4069||95.0|-5.97|2.43|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||2.43|-5.97|0.4069
91500627|NCT01722071|182871078|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.814
91500628|NCT01338493|182871080|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91500629|NCT01338493|182871081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91500630|NCT01846611|182871082|SUPERIORITY||Hazard Ratio (HR)|0.925|||=|0.5236|TWO_SIDED|95.0|0.727|1.177|||Unstratified log rank test|||||1.177|0.727|= 0.5236
91500631|NCT01846611|182871083|SUPERIORITY||Hazard Ratio (HR)|0.935|||=|0.5174|TWO_SIDED|95.0|0.762|1.147|||Unstratified log rank test|||||1.147|0.762|= 0.5174
91531294|NCT01607411|182939154|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.50|0.10|0.0040
91500632|NCT01846611|182871084|SUPERIORITY||Odds Ratio (OR)|1.523|||=|0.0142|TWO_SIDED|95.0|1.075|2.158|||Fisher Exact|||||2.158|1.075|= 0.0142
91500633|NCT00775645|182871101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.17|TWO_SIDED|95.0|-2.2|0.4|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||0.4|-2.2|0.17
91500634|NCT00775645|182871102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.92|TWO_SIDED|95.0|-3.0|2.7|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||2.7|-3|0.92
91500635|NCT00775645|182871103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2|TWO_SIDED|95.0|-0.7|3.3|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||3.3|-0.7|0.20
91500636|NCT00775645|182871104|SUPERIORITY|||||||0.46|||||||Regression, Linear|Adjusted for randomization stratification factors.||||||0.46
91500637|NCT02671422|182871113|OTHER||1 year-survival rate|0.342|||||TWO_SIDED|95.0|0.0|0.894|||||Confidence interval is computed based on the LOGLOG method.|||0.894|0.000|
91500638|NCT03061331|182871120|SUPERIORITY||Least Squares Mean Difference|0.1||||0.9277|TWO_SIDED|95.0|-2.5|2.7|||Mixed Model Repeated Measure (MMRM)|||||2.7|-2.5|0.9277
91500639|NCT02625259|182871121|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.83||||||Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.||1.83|1.00|
91500640|NCT02625259|182871121|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|0.86|1.67||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.||1.67|0.86|
91500641|NCT02625259|182871121|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.03|||||TWO_SIDED|90.0|0.02|0.07||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.07|0.02|
91500642|NCT02625259|182871123|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.47|||||TWO_SIDED|90.0|0.98|2.18||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.||2.18|0.98|
91531295|NCT01706965|182939161|SUPERIORITY|||||||0.38|||||||ANOVA|||Univariate ANOVA, controlling for baseline PANSS total||||.38
91500643|NCT02625259|182871123|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.76|||||TWO_SIDED|90.0|1.11|2.78||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.||2.78|1.11|
91500644|NCT02625259|182871123|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.02|||||TWO_SIDED|90.0|0.01|0.04||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.04|0.01|
91500645|NCT02625259|182871124|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.53|||||TWO_SIDED|90.0|0.93|2.51||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.||2.51|0.93|
91500646|NCT02625259|182871124|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|90.0|1.0|2.25||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.||2.25|1.00|
91500647|NCT02625259|182871124|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.08|||||TWO_SIDED|90.0|0.03|0.18||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.18|0.03|
91500648|NCT00513474|182871126|SUPERIORITY|||||||0.036|||||||Gray's test for competing risks|||||||.036
91500649|NCT04772755|182871130|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
91500650|NCT04772755|182871131|SUPERIORITY|||||||0.8918|||||||Mantel Haenszel|||||||0.8918
91500651|NCT04772755|182871132|SUPERIORITY|||||||0.6587|||||||Wilcoxon (Mann-Whitney)|||||||0.6587
91500652|NCT04772755|182871133|SUPERIORITY|||||||0.0059|||||||Wilcoxon (Mann-Whitney)|||||||0.0059
91500653|NCT04772755|182871134|SUPERIORITY|||||||0.1647|||||||Chi-squared|||||||0.1647
91500654|NCT04772755|182871135|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.0090
91500655|NCT04772755|182871136|SUPERIORITY|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||||||0.0273
91500656|NCT04772755|182871137|SUPERIORITY|||||||0.0458|||||||Chi-squared|||||||0.0458
91500657|NCT04772755|182871138|SUPERIORITY|||||||0.0976|||||||Chi-squared|||||||0.0976
91500658|NCT03761147|182871163|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91531296|NCT01706965|182939162|SUPERIORITY|ANOVA, controlled for baseline MATRICS||||||0.99|||||||ANOVA|||||||.99
91743832|NCT00301262|183382298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.489||0.1137||95.0|-0.57|5.31|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.31|-0.57|0.1137
91743833|NCT00301262|183382299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.23|STANDARD_ERROR_OF_MEAN|4.829||0.0123||95.0|-21.77|-2.7|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-2.70|-21.77|0.0123
91743834|NCT00301262|183382299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|4.883||0.8993||95.0|-10.27|9.03|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.03|-10.27|0.8993
91743835|NCT00301262|183382300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.03|STANDARD_ERROR_OF_MEAN|5.458|<|0.0001||95.0|11.25|32.81|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||32.81|11.25|<0.0001
91743836|NCT00301262|183382300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.74|STANDARD_ERROR_OF_MEAN|5.818||0.4165||95.0|-16.24|6.76|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||6.76|-16.24|0.4165
91743837|NCT00301262|183382301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.8|STANDARD_ERROR_OF_MEAN|4.351||0.0257||95.0|1.21|18.39|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||18.39|1.21|0.0257
91743838|NCT00301262|183382301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.36|STANDARD_ERROR_OF_MEAN|3.209||0.0971||95.0|-11.7|0.98|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.98|-11.70|0.0971
91743839|NCT00301262|183382302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.754||0.0726||95.0|-6.66|0.3|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.30|-6.66|0.0726
91743840|NCT00301262|183382302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|1.798||0.2581||95.0|-5.61|1.52|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.52|-5.61|0.2581
91500659|NCT05838742|182871190|OTHER|Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors.|Difference in Posterior Mean Change|0.47|||||TWO_SIDED|95.0|-0.23|1.17|||Mixed Models Analysis|Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy.|||Posterior mean difference with 95% credible interval is reported.|1.17|-0.23|
91500660|NCT05838742|182871190|OTHER|Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors.|Difference in Posterior Mean Change|0.25|||||TWO_SIDED|95.0|-0.46|0.95|||Mixed Models Analysis|Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy.|||Posterior mean difference with 95% credible interval is reported.|0.95|-0.46|
91743841|NCT00301262|183382303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|4.45||0.8158||95.0|-9.86|7.78|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.78|-9.86|0.8158
91743842|NCT00301262|183382303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.692||0.8464||95.0|-3.68|3.02|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||3.02|-3.68|0.8464
91743843|NCT00301262|183382304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|5.789||0.9529||95.0|-11.82|11.13|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||11.13|-11.82|0.9529
91743844|NCT00301262|183382304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|4.994||0.8899||95.0|-10.59|9.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.20|-10.59|0.8899
91743845|NCT00301262|183382305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.18|STANDARD_ERROR_OF_MEAN|7.897||0.2001||95.0|-25.83|5.47|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.47|-25.83|0.2001
91743846|NCT00301262|183382305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.68|STANDARD_ERROR_OF_MEAN|6.724||0.1527||95.0|-3.64|23.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.01|-3.64|0.1527
91743847|NCT00301262|183382306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_ERROR_OF_MEAN|7.774||0.0606||95.0|-0.67|30.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||30.15|-0.67|0.0606
91743848|NCT00301262|183382306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.62|STANDARD_ERROR_OF_MEAN|7.318||0.3678||95.0|-21.12|7.88|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.88|-21.12|0.3678
91743849|NCT00301262|183382307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|7.474||0.5429||95.0|-10.25|19.37|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||19.37|-10.25|0.5429
91743850|NCT00301262|183382307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.07|STANDARD_ERROR_OF_MEAN|5.595||0.5849||95.0|-8.02|14.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||14.15|-8.02|0.5849
91500661|NCT05838742|182871190|OTHER|Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors.|Difference in Posterior Mean Change|0.39|||||TWO_SIDED|95.0|-0.31|1.1|||Mixed Models Analysis|Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy.|||Posterior mean difference with 95% credible interval is reported.|1.10|-0.31|
91500662|NCT05838742|182871190|OTHER|Analysis performed using a Bayesian mixed model repeated measures adjusting for treatment, week, baseline, region and the treatment by week and baseline by week interactions using vague priors.|Difference in Posterior Mean Change|0.11|||||TWO_SIDED|95.0|-0.6|0.8|||Mixed Models Analysis|Analyzed using a joint model for change from baseline in average weekly pain score and time to intercurrent event handled using a composite strategy.|||Posterior mean difference with 95% credible interval is reported.|0.80|-0.60|
91500663|NCT00501293|182871279|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.028
91500664|NCT00501293|182871279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
91500665|NCT00501293|182871280|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.027
91500666|NCT00501293|182871280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
91500667|NCT00501293|182871283|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.071
91500668|NCT00501293|182871283|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||0.017
91500669|NCT01042236|182871304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.88||0.4907|TWO_SIDED|95.0|-1.18|2.41||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||2.41|-1.18|0.4907
91500670|NCT01042236|182871304|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.88||0.5944|TWO_SIDED|95.0|-2.27|1.32||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.32|-2.27|0.5944
91535610|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.07|STANDARD_ERROR_OF_MEAN|3.97||0.0061|TWO_SIDED|95.0|3.22|18.92||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.92|3.22|0.0061
91500671|NCT01042236|182871305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.94||0.987|TWO_SIDED|95.0|-1.91|1.94||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.94|-1.91|0.9870
91500672|NCT01042236|182871305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.94||0.4167|TWO_SIDED|95.0|-2.71|1.15||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.15|-2.71|0.4167
91500673|NCT01042236|182871306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9403|TWO_SIDED|95.0|-0.24|0.26||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.26|-0.24|0.9403
91500674|NCT01042236|182871306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.1881|TWO_SIDED|95.0|-0.42|0.09||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.09|-0.42|0.1881
91743851|NCT00301262|183382308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.86|STANDARD_ERROR_OF_MEAN|4.952||0.0002||95.0|9.08|28.64|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||28.64|9.08|0.0002
91743852|NCT00301262|183382308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|6.212||0.429||95.0|-7.35|17.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||17.20|-7.35|0.4290
91743853|NCT01668628|183382310|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.||||0.008
91743854|NCT01668628|183382310|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.||||0.008
91743855|NCT01668628|183382310|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group||||0.008
91743856|NCT01668628|183382310|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.||||0.157
91743857|NCT01716039|183382312|OTHER|Comparing the change in the modified Baron score from baseline to week 18 between the treatment groups||||||0.758|||||||Wilcoxon (Mann-Whitney)|||||||0.758
91743858|NCT01716039|183382312|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91743859|NCT01716039|183382313|OTHER|||||||0.908||||||p-value for the overall treatment difference is based on an analysis of covariance adjusting for baseline UCEIS|ANCOVA|||||||0.908
91743860|NCT02150057|183382458|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91743861|NCT02388165|183382459|SUPERIORITY||Vaccine Efficacy (VE)|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The confidence interval (CI) was calculated using the Clopper-Pearson method.|||55.81|-126.30|
91743862|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|8.3|||<|0.001|TWO_SIDED|95.0|6.9|9.8|||Miettinen and Nurminen|||Redness: Any||9.8|6.9|<0.001
91743863|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|4.4|||||TWO_SIDED|95.0|3.3|5.6||||||Redness: Mild||5.6|3.3|
91743864|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|2.3|4.0||||||Redness: Moderate||4.0|2.3|
91743865|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|0.5|1.4||||||Redness: Severe||1.4|0.5|
91743866|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|7.0|||<|0.001|TWO_SIDED|95.0|5.7|8.4|||Miettinen and Nurminen|||Swelling: Any||8.4|5.7|<0.001
91743867|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|3.9|||||TWO_SIDED|95.0|2.8|5.0||||||Swelling: Mild||5.0|2.8|
91743868|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|2.4|||||TWO_SIDED|95.0|1.7|3.3||||||Swelling: Moderate||3.3|1.7|
91743869|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|0.4|1.2||||||Swelling: Severe||1.2|0.4|
91743870|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|15.7|||<|0.001|TWO_SIDED|95.0|13.3|18.1|||Miettinen and Nurminen|||Pain at the injection site: Any||18.1|13.3|<0.001
91743871|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|12.2|||||TWO_SIDED|95.0|10.0|14.5||||||Pain at the injection site: Mild||14.5|10.0|
91743872|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|1.9|4.2||||||Pain at the injection site: Moderate||4.2|1.9|
91743873|NCT02388165|183382460|SUPERIORITY||Difference in percentage of participants|0.5|||||TWO_SIDED|95.0|0.1|1.0||||||Pain at the injection site: Severe||1.0|0.1|
91743874|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.6||||0.146|TWO_SIDED|95.0|-0.2|1.6|||Miettinen and Nurminen|||Fever: Any||1.6|-0.2|0.146
91743875|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||Fever: 38.0 degree C to 38.4 degree C||1.2|-0.3|
91743876|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.4|0.6||||||Fever: 38.5 degree C to 38.9 degree C||0.6|-0.4|
91500675|NCT01042236|182871307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.8602|TWO_SIDED|95.0|-0.26|0.22||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.22|-0.26|0.8602
91500676|NCT01042236|182871307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1271|TWO_SIDED|95.0|-0.43|0.06||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.06|-0.43|0.1271
91500677|NCT01172847|182871330|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.91|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||1.05|0.91|
91535611|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.95||0.4342|TWO_SIDED|95.0|-4.72|10.93||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||10.93|-4.72|0.4342
91743877|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.5||||||Fever: 39.0 degree C to 40.0 degree C||0.5|-0.2|
91743878|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.3||||||Fever: \>40.0 degree C||0.3|-0.2|
91743879|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|2.9||||0.093||95.0|-0.5|6.2|||Miettinen and Nurminen|||Fatigue: Any||6.2|-0.5|0.093
91500678|NCT01172847|182871330|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.02|0.95|
91743880|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-0.9|3.7||||||Fatigue: Mild||3.7|-0.9|
91743881|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.3|||||TWO_SIDED|95.0|-1.6|4.2||||||Fatigue: Moderate||4.2|-1.6|
91743882|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.2|||||TWO_SIDED|95.0|-1.2|1.6||||||Fatigue: Severe||1.6|-1.2|
91743883|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.2||||0.443|TWO_SIDED|95.0|-1.9|4.4|||Miettinen and Nurminen|||Headache: Any||4.4|-1.9|0.443
91743884|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||Headache: Mild||2.3|-2.9|
91743885|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.5|||||TWO_SIDED|95.0|-0.7|3.8||||||Headache: Moderate||3.8|-0.7|
91743886|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-0.8|0.8||||||Headache: Severe||0.8|-0.8|
91743887|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.0||||0.462|TWO_SIDED|95.0|-1.6|3.4|||Miettinen and Nurminen|||Diarrhea: Any||3.4|-1.6|0.462
91500679|NCT01172847|182871331|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|1.0|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of rimantadine||1.06|1.00|
91500680|NCT01172847|182871332|SUPERIORITY_OR_OTHER||mean exposure ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||0.96|0.77|
91500681|NCT01172847|182871332|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.05|0.92|
91500682|NCT01172847|182871333|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|0.99|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|mean exposure ratio of rimantadine||1.06|0.99|
91500683|NCT00183092|182871338|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.43||||0.43|TWO_SIDED|95.0|0.58|3.53|||Regression, Cox|||||3.53|0.58|0.43
91743888|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.5|3.0||||||Diarrhea: Mild||3.0|-1.5|
91743889|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.5||||||95.0|-0.7|1.7||||||Diarrhea: Moderate||1.7|-0.7|
91743890|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Diarrhea: Severe||0.2|-1.0|
91500684|NCT00183092|182871339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.54||95.0||||Threshold for statistical significance = 0.05. One subject in the placebo group was administered only 25 items on the MMSE due to visual impairment, and this subject's score was scaled based on percentage correct.|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.54
91500685|NCT00183092|182871340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.9||||0.36||95.0||||significance threshold p=0.05|Quade's rank analysis of covariance|||The difference between scores, adjusted for Month-0 performance.||||.36
91500686|NCT00183092|182871341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.01||95.0||||Significance threshold p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.01
91743891|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|-0.6||||0.3||95.0|-1.8|0.5|||Miettinen and Nurminen|||Vomiting: Any||0.5|-1.8|0.300
91743892|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|-0.2|||||TWO_SIDED|95.0|-1.3|0.8||||||Vomiting: Mild||0.8|-1.3|
91743893|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|-0.4||||||95.0|-0.9|0.1||||||Vomiting: Moderate||0.1|-0.9|
91743894|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.7||||0.276||95.0|-1.3|4.7|||Miettinen and Nurminen|||Muscle pain: Any||4.7|-1.3|0.276
91743895|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.2|2.8||||||Muscle pain: Mild||2.8|-1.2|
91743896|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-1.4|3.5||||||Muscle pain: Moderate||3.5|-1.4|
91500687|NCT00183092|182871342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.03||95.0||||Threshold for significance p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.03
91500688|NCT00183092|182871343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.92||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.92
91500689|NCT00183092|182871344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.71
91500690|NCT00183092|182871345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.7||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted change (worsening) in the quinacrine group.||||0.70
91500691|NCT02132767|182871346|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91500692|NCT02132767|182871347|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
91500693|NCT02132767|182871348|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
91500694|NCT02132767|182871349|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
91743897|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|-0.2||||||95.0|-1.2|0.8||||||Muscle pain: Severe||0.8|-1.2|
91743898|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.7||||0.273|TWO_SIDED|95.0|-1.3|4.6|||Miettinen and Nurminen|||Joint pain: Any||4.6|-1.3|0.273
91743899|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|1.6|||||TWO_SIDED|95.0|-0.2|3.6||||||Joint pain: Mild||3.6|-0.2|
91743900|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-2.6|2.4||||||Joint pain: Moderate||2.4|-2.6|
91743901|NCT02388165|183382461|SUPERIORITY||Difference in percentage of participants|0.1||||||95.0|-0.9|1.0||||||Joint pain: Severe||1.0|-0.9|
91500695|NCT02132767|182871350|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
91500696|NCT02132767|182871351|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
91535612|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.07||0.242|TWO_SIDED|95.0|-6.53|1.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.66|-6.53|0.2420
91743902|NCT02388165|183382469|SUPERIORITY||VE|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||55.81|-126.30|
91743903|NCT02388165|183382470|SUPERIORITY||VE|-9.09|||||TWO_SIDED|95.0|-104.06|41.41|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||41.41|-104.06|
91743904|NCT02388165|183382471|SUPERIORITY||VE|-8.7|||||TWO_SIDED|95.0|-100.42|40.8|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||40.80|-100.42|
91743905|NCT04551963|183382494|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.42|0.56||||||Arm A: Zanubrutinib alone vs. Zanubrutinib + fluconazole||0.56|0.42|
91743906|NCT04551963|183382494|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.42|||||TWO_SIDED|90.0|0.34|0.51||||||Arm a: Zanubrutinib alone vs. Zanubrutinib + diltiazem||0.51|0.34|
91743907|NCT04551963|183382495|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||0.99|0.66|
91743908|NCT04551963|183382495|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.41|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.41|
91743909|NCT04551963|183382496|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||1.08|0.82|
91743910|NCT04551963|183382496|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.99|0.66|
91743911|NCT04551963|183382497|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.83|||||TWO_SIDED|90.0|0.65|1.06||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.06|0.65|
91743912|NCT04551963|183382497|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.48|||||TWO_SIDED|90.0|0.4|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.40|
91743913|NCT04551963|183382498|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.45|||||TWO_SIDED|90.0|0.35|0.58||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||0.58|0.35|
91743914|NCT04551963|183382498|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.41|||||TWO_SIDED|90.0|0.32|0.51||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.51|0.32|
91500697|NCT02132767|182871352|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
91500698|NCT02132767|182871353|SUPERIORITY_OR_OTHER|||||||0.73|||||||Regression, Poisson|||||||0.73
91500699|NCT02865187|182871361|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.0||0.71|TWO_SIDED|95.0|-7.4|5.1||a priori threshold for significance was set at p\<0.05|t-test, 2 sided|||||5.1|-7.4|0.71
91500700|NCT02865187|182871362|SUPERIORITY||Chi square|0.0||||1|TWO_SIDED|||||a priori threshold for significance was set at p\< 0.05.|Chi-squared|||||||1.00
91500701|NCT03557151|182871408|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.33||0.895|TWO_SIDED|95.0|-0.68|0.6|||Mixed Models Analysis|||Transdisciplinary Care is being compared to Usual Care using the Time 2 HbA1c (as baseline) and Time 5 HbA1c (as the outcome) controlling for race/ethnicity, gender, and age of the patient. The interaction of condition and time is used to evaluate the treatment effect. Missing data were not imputed.||0.60|-0.68|0.895
91500702|NCT03557151|182871409|SUPERIORITY||Slope|2.29|STANDARD_ERROR_OF_MEAN|2.34||0.33|TWO_SIDED|95.0|-2.29|6.88|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data, controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to examine the treatment effect. Missing data were not imputed.||6.88|-2.29|.33
91500703|NCT03557151|182871410|SUPERIORITY||Slope|4.1|STANDARD_ERROR_OF_MEAN|2.25||0.07|TWO_SIDED|95.0|-0.32|8.53|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data and controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to evaluate the treatment effect. Missing data are not imputed.||8.53|-.32|.07
91500704|NCT03557151|182871411|SUPERIORITY||Slope|-2.38|STANDARD_ERROR_OF_MEAN|3.77||0.527|TWO_SIDED|95.0|-9.77|5.0|||Mixed Models Analysis|||This analysis included baseline and 12-month data. The interaction of condition (TC or UC) and time was used to examine the treatment effect. Child sex, age, and race/ethnicity were covariates. Missing data were not imputed.||5.0|-9.77|.527
91500705|NCT03557151|182871412|SUPERIORITY||Slope|-3.3|STANDARD_ERROR_OF_MEAN|2.89||0.253|TWO_SIDED|95.0|-8.94|2.35|||Mixed Models Analysis|||This analysis uses baseline and 12 month data. The interaction of condition and time is used to evaluate the treatment effect. Child sex, age, and race/ethnicity were used as covariates. Missing data were not imputed.||2.35|-8.94|.253
91500706|NCT03557151|182871413|SUPERIORITY||Slope|9.69|STANDARD_ERROR_OF_MEAN|3.77||0.01|TWO_SIDED|95.0|2.31|17.08|||Mixed Models Analysis|||This analysis included baseline and 12 month data. The condition by time interaction was used to evaluate the treatment effect. Child age, sex, and race/ethnicity were included as covariates. Missing data were not imputed.||17.08|2.31|0.01
91743915|NCT04551963|183382499|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.82|||||TWO_SIDED|90.0|0.68|1.0||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.00|0.68|
91500707|NCT03557151|182871414|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|2.07||0.83|TWO_SIDED|95.0|-3.62|4.35|||Mixed Models Analysis|||This analysis uses baseline and 12-month data. The interaction between condition and time is used to evaluate the treatment effect. Child age, sex, and race/ethnicity were covariates. Missing data were not imputed.||4.35|-3.62|.83
91743916|NCT04551963|183382499|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.5|||||TWO_SIDED|90.0|0.39|0.64||||||Arm B: Zanubrutinib alone vs. zanubrutinib + clarithromycin||0.64|0.39|
91743917|NCT02974855|183382520|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
91743918|NCT02974855|183382520|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.05||||0.0001|TWO_SIDED|80.0|0.02|0.14|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.14|0.02|0.0001
91743919|NCT02974855|183382520|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
91743920|NCT02974855|183382520|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.03||||0.0005|TWO_SIDED|80.0|0.01|0.1|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.10|0.01|0.0005
91743921|NCT02974855|183382520|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.09|||<|0.0001|TWO_SIDED|80.0|0.05|0.16|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.16|0.05|<0.0001
91743922|NCT02974855|183382520|SUPERIORITY||ratio|0.18|||<|0.0001|TWO_SIDED|80.0|0.11|0.31|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.31|0.11|<0.0001
91743923|NCT02974855|183382520|SUPERIORITY||ratio|0.1||||0.0002|TWO_SIDED|80.0|0.04|0.22|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.22|0.04|0.0002
91743924|NCT02974855|183382520|SUPERIORITY||ratio|0.2||||0.0154|TWO_SIDED|80.0|0.09|0.47|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.47|0.09|0.0154
91743925|NCT02974855|183382520|SUPERIORITY||ratio|0.04||||0.0005|TWO_SIDED|80.0|0.01|0.14|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.14|0.01|0.0005
91743926|NCT02974855|183382520|SUPERIORITY||ratio|0.12|||<|0.0001|TWO_SIDED|80.0|0.08|0.2|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.20|0.08|<0.0001
91743927|NCT01474772|183382537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0659|TWO_SIDED|95.0|-0.46|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints had p-values that were less than 0.05, hence there was no need for multiplicity adjustment.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. Last observation carried forward (LOCF) approach was applied.||0.01|-0.46|0.0659
91759519|NCT02391363|183411770|SUPERIORITY|||||||0.88||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.88
91500708|NCT00923598|182871436|EQUIVALENCE|A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.|Mean Difference (Final Values)|3.0||||0.05|TWO_SIDED|95.0|-10.0|17.0|||Fisher Exact|||||17|-10|0.05
91500709|NCT00467259|182871452|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
91535613|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|2.05||0.981|TWO_SIDED|95.0|-4.12|4.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.02|-4.12|0.9810
91743928|NCT01474772|183382538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.128||0.0242|TWO_SIDED|95.0|-0.543|-0.038||Primary analysis was two-sided and performed at the 0.05 significance level. Unstructured covariance structure was used to estimate the within-participant errors.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||This longitudinal analysis was a sensitivity analysis of the primary endpoint. P-value was based on a repeated measure mixed effects model including pooled center, time point, treatment, an indicator variable for Week 6 as well as interaction terms as fixed effect factors. For analysis purpose, it is assumed that participants were on placebo at Baseline, took the same treatment as in Period 1 during Week 1 of washout, and were on placebo in Week 2 of washout.||-0.038|-0.543|0.0242
91743929|NCT01474772|183382539|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.412|TWO_SIDED|95.0|-0.44|0.18||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints have p-values that are less than 0.05, hence there was no need for multiplicity adjustment.|Mixed-Effect Model Repeated Measures|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a repeated measure linear mixed effects model including baseline pain, sequence, period, center, time, treatment, and treatment by time interaction as fixed effect factors and participant within sequence and within-participant error as random factors. The model term 'time' may take 2 values corresponding to Week 3 and Week 6 in each period.||0.18|-0.44|0.4120
91743930|NCT01474772|183382540|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0847|TWO_SIDED|95.0|0.94|2.55||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.55|0.94|0.0847
91743931|NCT01474772|183382541|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2459|TWO_SIDED|95.0|0.8|2.39||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.39|0.80|0.2459
91743932|NCT01474772|183382542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0889|TWO_SIDED|95.0|-1.71|0.12||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.12|-1.71|0.0889
91743933|NCT01474772|183382543|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.86||0.1781|TWO_SIDED|95.0|-2.86|0.53||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.53|-2.86|0.1781
91743934|NCT01474772|183382544|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.2719|TWO_SIDED|95.0|-0.53|0.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.15|-0.53|0.2719
91743935|NCT01474772|183382545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|563.39|STANDARD_ERROR_OF_MEAN|4098.74||0.8909|TWO_SIDED|95.0|-7549.82|8676.6||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||8676.60|-7549.82|0.8909
91743936|NCT01474772|183382546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|206.37||0.9899|TWO_SIDED|95.0|-411.26|406.01||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||406.01|-411.26|0.9899
91500710|NCT00467259|182871453|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
91743937|NCT01474772|183382547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.27||0.2854|TWO_SIDED|95.0|-3.88|1.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||1.15|-3.88|0.2854
91743938|NCT01474772|183382548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.09||0.1805|TWO_SIDED|95.0|-3.6|0.68||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.68|-3.60|0.1805
91500711|NCT00467259|182871454|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
91500712|NCT03715764|182871527|SUPERIORITY|||||||0.87||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.87
91500713|NCT03715764|182871527|SUPERIORITY||||||<|0.001||||||Results for the final model for the variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||<0.001
91500714|NCT03715764|182871527|SUPERIORITY|||||||0.18||||||Results for the final model, variable Group x Time (Statistical interaction of group and time), adjusted for confounders.|Mixed Models Analysis|||||||0.18
91500715|NCT03715764|182871528|SUPERIORITY|||||||0.56||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.56
91743939|NCT01474772|183382549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.3028|TWO_SIDED|95.0|-0.99|0.31||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.31|-0.99|0.3028
91743940|NCT01474772|183382550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7542|TWO_SIDED|95.0|-0.41|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.30|-0.41|0.7542
91743941|NCT01474772|183382551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.68||0.0634|TWO_SIDED|95.0|-2.62|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-2.62|0.0634
91743942|NCT01474772|183382552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1985|TWO_SIDED|95.0|-0.13|0.62||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.62|-0.13|0.1985
91743943|NCT01474772|183382553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9686|TWO_SIDED|95.0|-0.21|0.2||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.20|-0.21|0.9686
91743944|NCT01474772|183382554|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.002|TWO_SIDED|95.0|1.3|4.95|||Cochran-Mantel-Haenszel|||Odds ratio is based on the binary response for any improvement while p-value is from the comparison of the original scale of 7 possible outcomes. P-value was calculated by using Cochran Mantel-Haenszel (CMH) test. PGIC values at the end of Period 1 data was compared between treatment groups.||4.95|1.30|0.0020
91743945|NCT01474772|183382555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0105|TWO_SIDED|95.0|-0.68|-0.09||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||-0.09|-0.68|0.0105
91743946|NCT01474772|183382556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1178|TWO_SIDED|95.0|-0.63|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-0.63|0.1178
91760158|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.61|||||TWO_SIDED|95.0|0.74|6.47||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.47|0.74|
91500716|NCT03715764|182871528|SUPERIORITY|||||||0.0049||||||Results for the final model, variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||0.0049
91500717|NCT03715764|182871528|SUPERIORITY|||||||0.49||||||Results for the final model, adjusted for confounders, for the variable Group x Time (Statistical interaction of group and time).|Mixed Models Analysis|||||||0.49
91500718|NCT03715764|182871529|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
91500719|NCT03715764|182871530|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
91743947|NCT01474772|183382557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.199|TWO_SIDED|95.0|-0.6|0.13||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.13|-0.60|0.1990
91743948|NCT01474772|183382558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.02||0.71107|TWO_SIDED|95.0|-0.025|0.037||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 1997. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.037|-0.025|0.71107
91743949|NCT01474772|183382558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.02||0.53965|TWO_SIDED|95.0|-0.021|0.039||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 2001. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.039|-0.021|0.53965
91743950|NCT00365105|183382571|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.844|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||Assuming an exponential distribution, the weighted yearly SRE hazard rate for patients treated with bisphosphonates only is 0.7991 which translates to a median time to SRE of 10.4 months. The study was designed to show a 33% relative reduction in the yearly SRE hazard rate, i.e. 15.6 months median time to SRE. Using a two-sided log-rank test assuming a type I error of 0.05, one planned interim analysis with 90% statistical power, 257 SREs are required with a total of 316 patients.||1.54|0.70|0.844
91743951|NCT00365105|183382572|SUPERIORITY|The power of detecting an improvement from 55% in the control arm to 41% in the experimental arm with a two-sided Fisher's exact test at alpha 0.05 is 66%.||||||0.26|||||||Fisher Exact|||||||0.26
91743952|NCT00365105|183382573|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.37|TWO_SIDED|95.0|0.86|1.52|||Log Rank|||Assuming the disease site distribution is 40%, 40%, and 20% from prostate, breast, and lung cancer populations, respectively, the weighted yearly death rate for patients treated with bisphosphonates only is 0.4390, translating to a median overall survival time of 18.9 months assuming an exponential distribution. Statistical power to detect a relative difference of 33% in the yearly death rate is 70% using a two-sided log-rank test at a 0.05 significance level and 87% to detect 50% difference.||1.52|0.86|0.37
91743953|NCT00365105|183382574|SUPERIORITY|||||||0.96||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||FACT-G Total||||0.96
91743954|NCT00365105|183382574|SUPERIORITY|||||||0.97||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Physical Well-Being||||0.97
91743955|NCT00365105|183382574|SUPERIORITY|||||||0.57||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Social/Family Well-Being||||0.57
91743956|NCT00365105|183382574|SUPERIORITY|||||||0.7||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Emotional Well-Being||||0.70
91743957|NCT00365105|183382574|SUPERIORITY|||||||0.46||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Functional Well-Being||||0.46
91743958|NCT00365105|183382575|SUPERIORITY|||||||0.99||||||2-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
91743959|NCT00365105|183382576|SUPERIORITY|||||||0.43||||||Significance level of 0.05|t-test, 2 sided|||Index Score||||0.43
91743960|NCT00365105|183382576|SUPERIORITY|||||||0.15||||||Significance level of 0.05|t-test, 2 sided|||VAS Score||||0.15
91743961|NCT03367403|183382705|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.56||0.042|TWO_SIDED|95.0|0.12|6.27|||Mixed Models Analysis|||||6.27|0.12|0.042
91743962|NCT03367403|183382706|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.898||0.04|TWO_SIDED|95.0|-3.63|-0.09|||Mixed Models Analysis|||||-0.09|-3.63|0.040
91743963|NCT03367403|183382707|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.239||0.139|TWO_SIDED|95.0|-0.83|0.12|||Mixed Models Analysis|||||0.12|-0.83|0.139
91743964|NCT03367403|183382708|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.525||0.227|TWO_SIDED|95.0|-0.4|1.67|||Mixed Models Analysis|||||1.67|-0.40|0.227
91743965|NCT03367403|183382709|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|1.009||0.23|TWO_SIDED|95.0|-0.77|3.2|||Mixed Models Analysis|||||3.20|-0.77|0.230
91743966|NCT03367403|183382710|SUPERIORITY||Mean Difference (Final Values)|-85.06|STANDARD_ERROR_OF_MEAN|3.867|<|0.001|TWO_SIDED|95.0|-92.68|-77.43|||Mixed Models Analysis|||||-77.43|-92.68|<0.001
91743967|NCT03367403|183382711|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.56|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Tau-IQ||0.03|-0.01|0.560
91743968|NCT03367403|183382711|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.012|TWO_SIDED|95.0|0.007|0.062|||ANCOVA|||MUBADA-Cerebellum||0.062|0.007|0.012
91500720|NCT00662363|182871539|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||independent sample t test|||Primary outcome measures chosen were between group comparisons for change on Constipation Symptom Questionnaire ratings at exit from the study. The PAC-SYM is a symptom scale where higher numbers indicate more symptoms. Change from baseline to Day 7 was calculated and larger negative differences indicated greater improvement in constipation symptoms. The PAC-QOL is a quality of life scale where higher numbers indicate better quality of life. Change from baseline to 7 days was calculated.||||<0.05
91500721|NCT01905657|182871541|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.54||||0.00024|TWO_SIDED|95.0|0.38|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.38|0.00024
91743969|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-2.67|STANDARD_ERROR_OF_MEAN|0.631|<|0.001|TWO_SIDED|95.0|-3.92|-1.43|||Mixed Models Analysis|||Bilateral Cortical||-1.43|-3.92|< 0.001
91743970|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.011||0.916|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||Bilateral Entorhinal Cortex||0.02|-0.02|0.916
91743971|NCT03367403|183382712|SUPERIORITY|Bilateral Hippocampus|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.019||0.771|TWO_SIDED|95.0|-0.03|0.04|||Mixed Models Analysis|||||0.04|-0.03|0.771
91743972|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.047||0.094|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||Bilateral Inferior Parietal Lobe||0.01|-0.17|0.094
91743973|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.052|TWO_SIDED|95.0|-0.04|0.0|||Mixed Models Analysis|||Bilateral Isthmuscingulate||0.00|-0.04|0.052
91743974|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.005|TWO_SIDED|95.0|-0.57|-0.11|||Mixed Models Analysis|||Bilateral Lateral Parietal Lobe||-0.11|-0.57|0.005
91743975|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.036||0.731|TWO_SIDED|95.0|-0.08|0.06|||Mixed Models Analysis|||Bilateral Medial Temporal Lobe||0.06|-0.08|0.731
91743976|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.046|<|0.001|TWO_SIDED|95.0|-0.25|-0.07|||Mixed Models Analysis|||Bilateral Precuneus||-0.07|-0.25|<0.001
91743977|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.114|<|0.001|TWO_SIDED|95.0|-0.62|-0.17|||Mixed Models Analysis|||Bilateral Prefrontal Lobe||-0.17|-0.62|<0.001
91743978|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Models Analysis|||Bilateral Superior Temporal Lobe||-0.12|-0.30|<0.001
91743979|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|2.28|STANDARD_ERROR_OF_MEAN|0.581|<|0.001|TWO_SIDED|95.0|1.14|3.43|||Mixed Models Analysis|||Bilateral Ventricles||3.43|1.14|< 0.001
91743980|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.519||0.003|TWO_SIDED|95.0|-7.58|-1.59|||Mixed Models Analysis|||Bilateral Whole Brain||-1.59|-7.58|0.003
91743981|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.03|-0.33|||Mixed Models Analysis|||Bilateral Whole Temporal Lobe||-0.33|-1.03|<0.001
91743982|NCT03367403|183382712|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.987||0.022|TWO_SIDED|95.0|-4.23|-0.33|||Mixed Models Analysis|||Bilateral White Matter||-0.33|-4.23|0.022
91743983|NCT03497975|183382747|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0309|TWO_SIDED|95.0|1.07|4.13||Logistic regression model includes WI-NRS baseline score as a covariate, treatment and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||4.13|1.07|0.0309
91743984|NCT03497975|183382748|SUPERIORITY||Difference in LS Mean|-7.06|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.82|-3.3||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline ItchyQoL value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-3.30|-10.82|0.0002
91743985|NCT03497975|183382749|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0179|TWO_SIDED|95.0|1.11|3.07||Logistic regression model includes PAS (Item 5a) baseline score as a covariate, treatment as a fixed effect and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||3.07|1.11|0.0179
91743986|NCT03497975|183382750|SUPERIORITY||Difference in LS Mean|-4.43|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-6.55|-2.31||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline PROMIS value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-2.31|-6.55|<0.0001
91743987|NCT01407952|183382766|SUPERIORITY||Odds Ratio (OR)|2.32||||0.002|TWO_SIDED|95.0|1.36|3.97|||Regression, Logistic|||A intent to treat analysis was performed, using multiple imputation methods.||3.97|1.36|0.002
91743988|NCT01407952|183382766|SUPERIORITY||Odds Ratio (OR)|3.97|||<|0.01|TWO_SIDED|95.0|1.99|7.92||Chi-squared test statistic with one degree of freedom=17.37|Chi-squared|||||7.92|1.99|<0.01
91743989|NCT01407952|183382767|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91743990|NCT01407952|183382768|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
91743991|NCT01407952|183382769|SUPERIORITY|||||||0.352|||||||Chi-squared|Chi-squared test statistic with one degree of freedom = 0.865||||||0.352
91743992|NCT01407952|183382770|SUPERIORITY|||||||0.769|||||||Cochran-Armitage Trend Test|||||||0.769
91743993|NCT01407952|183382771|SUPERIORITY|||||||0.641|||||||Chi-squared|Chi-square test statistic with one degree of freedom=0.217||||||0.641
91743994|NCT01407952|183382772|SUPERIORITY|||||||0.003|||||||Chi-squared|chi-square test statistic with one degree of freedom=8.82||||||0.003
91743995|NCT01407952|183382773|SUPERIORITY|||||||0.162|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=1.955||||||0.162
91743996|NCT01407952|183382774|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
91743997|NCT01407952|183382775|SUPERIORITY||||||<|0.01|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=14.743||||||<0.01
91743998|NCT01407952|183382776|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91743999|NCT00935493|183382777|SUPERIORITY_OR_OTHER|||||||0.06|||||||Regression, Linear|||||||0.06
91744000|NCT00935493|183382777|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Linear|||||||0.47
91744001|NCT00935493|183382778|SUPERIORITY_OR_OTHER|||||||0.67|||||||Regression, Logistic|||||||0.67
91500722|NCT01905657|182871541|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.5||||2e-05|TWO_SIDED|95.0|0.36|0.7|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.70|0.36|0.00002
91500723|NCT01905657|182871541|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.71||||0.00076|TWO_SIDED|95.0|0.58|0.88|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.88|0.58|0.00076
91500724|NCT01905657|182871541|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.49|0.75|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.75|0.49|<0.00001
91500725|NCT01905657|182871542|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.58||||9e-05|TWO_SIDED|95.0|0.43|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.43|0.00009
91500726|NCT01905657|182871542|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.59||||7e-05|TWO_SIDED|95.0|0.45|0.78|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.78|0.45|0.00007
91500727|NCT01905657|182871542|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.88||||0.06758|TWO_SIDED|95.0|0.73|1.04|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||1.04|0.73|0.06758
91500728|NCT01905657|182871542|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.79||||0.00462|TWO_SIDED|95.0|0.66|0.94|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.94|0.66|0.00462
91500729|NCT01905657|182871545|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-2.3||||0.66608|TWO_SIDED|95.0|-12.7|8.2||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||8.2|-12.7|0.66608
91500730|NCT01905657|182871545|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|22.2|||<|1e-05|TWO_SIDED|95.0|14.0|30.7||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||30.7|14.0|<0.00001
91500731|NCT01905657|182871545|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|8.7||||0.00045|TWO_SIDED|95.0|3.6|13.9||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||13.9|3.6|0.00045
91500732|NCT01905657|182871545|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|9.1||||0.00024|TWO_SIDED|95.0|4.1|14.3||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||14.3|4.1|0.00024
91744002|NCT00935493|183382778|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.46
91744003|NCT00935493|183382779|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||||||0.65
91744004|NCT00935493|183382779|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
91744005|NCT00940290|183382805|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Kruskal-Wallis|||After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statistic||||0.007
91744006|NCT02016716|183382808|NON_INFERIORITY|Non-inferiority was claimed if the lower bound of the 1-sided 97.5% CI (or the lower bound of 2-sided 95% CI) of the mean difference between the 2 romosozumab groups was \> -2.0%.|Least Squares Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.7|||||Based on ANCOVA model adjusting for treatment, and baseline lumbar spine BMD T-score.|The primary hypothesis was that the mean percent change from baseline in lumbar spine BMD at month 6 in participants receiving romosozumab 210 mg QM using the 90 mg/mL concentration would not be inferior to that in participants receiving romosozumab 210 mg QM using the 70 mg/mL concentration.||0.7|-1.5|
91744007|NCT02931838|183382813|SUPERIORITY|||||||0.4873||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.4873
91744008|NCT02931838|183382813|SUPERIORITY|||||||0.0003||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.0003
91744009|NCT02931838|183382813|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
91744010|NCT02931838|183382813|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||< 0.0001
91500733|NCT06092710|182871556|OTHER|Then, to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.||||||0.05572|||||||Kruskal-Wallis|||Non-parametric tests on patient sensitivity, given the non-normal distribution, (based on the median of the data) were applied to analyse the diﬀerences between the groups (ST1+ ST2 according to the STATUS3 and STATUS4 classification criteria). To analyse any diﬀerences in sensitivity between patient groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and ideally greater than 5% would indicate the absence of diﬀerences between groups.||||0.05572
91535614|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.05||0.2468|TWO_SIDED|95.0|-6.44|1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.67|-6.44|0.2468
91744011|NCT02931838|183382813|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
91744012|NCT01963767|183382823|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||Ancovas were conducted with group as the between subjects factor and performance at baseline as the covariate.||||.03
91744013|NCT01659996|183382824|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was \< δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.11|||||TWO_SIDED|95.0|-3.11|2.93||||||Meningococcal serogroup A: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||2.93|-3.11|
91744014|NCT01659996|183382824|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.27|||||TWO_SIDED|95.0|-0.84|3.64||||||Meningococcal serogroup C: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.64|-0.84|
91744015|NCT01659996|183382824|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|2.46|||||TWO_SIDED|95.0|0.14|5.14||||||Meningococcal serogroup Y: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||5.14|0.14|
91744016|NCT01659996|183382824|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.28|||||TWO_SIDED|95.0|-0.84|3.67||||||Meningococcal serogroup W-135: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.67|-0.84|
91744017|NCT01659996|183382829|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.949|||||TWO_SIDED|95.0|0.852|1.06||||||Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively||1.06|0.852|
91744018|NCT01659996|183382829|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.968|||||TWO_SIDED|95.0|0.866|1.08||||||Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively||1.08|0.866|
91744019|NCT01659996|183382829|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|0.937|1.31||||||Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively||1.31|0.937|
91744020|NCT01659996|183382830|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-1.22|||||TWO_SIDED|95.0|-5.44|3.19||||||Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.||3.19|-5.44|
91744021|NCT01659996|183382830|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|0.867|||||TWO_SIDED|95.0|-2.54|4.53||||||Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.||4.53|-2.54|
91744022|NCT01659996|183382830|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.092|||||TWO_SIDED|95.0|-3.62|3.66||||||Pertactin (PRN) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.||3.66|-3.62|
91744023|NCT03823287|183382835|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.1|2.5|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||2.5|-1.1|
91744024|NCT03823287|183382836|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-1.2|2.7|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||2.7|-1.2|
91744025|NCT03823287|183382838|OTHER||Difference in CMH Weighted Percentage|4.3|||||TWO_SIDED|95.0|-1.6|10.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||10.1|-1.6|
91744026|NCT03823287|183382838|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.0|12.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||12.7|-2.0|
91744027|NCT03823287|183382838|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.6|8.9|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.9|-6.6|
91744028|NCT03823287|183382838|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||5.4|-7.9|
91744029|NCT03823287|183382839|OTHER||Difference in CMH Weighted Percentage|2.7|||||TWO_SIDED|95.0|-3.2|8.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||8.5|-3.2|
91744030|NCT03823287|183382844|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.2|4.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||4.8|-2.2|
91744031|NCT03823287|183382844|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.6|3.9|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||3.9|-4.6|
91744032|NCT03823287|183382844|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-4.0|6.4|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||6.4|-4.0|
91744033|NCT03823287|183382845|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-3.9|3.6|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.6|-3.9|
91744034|NCT03823287|183382849|OTHER||Difference in CMH Weighted Percentage|3.0|||||TWO_SIDED|95.0|-3.6|9.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||9.5|-3.6|
91744035|NCT03823287|183382851|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-7.7|6.6|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||6.6|-7.7|
91744036|NCT03823287|183382853|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-4.2|3.3|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||3.3|-4.2|
91500734|NCT06092710|182871556|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.|||||<|8e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000008
91744037|NCT03823287|183382861|OTHER||Adjusted mean difference|-7.4|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-15.7|0.8|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||0.8|-15.7|
91744038|NCT03823287|183382862|OTHER||Adjusted mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.26|||TWO_SIDED|95.0|-7.4|9.4|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.4|-7.4|
91744039|NCT01456195|183382953|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.72|-0.24||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.24|-0.72|<0.001
91744040|NCT01456195|183382953|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.0|-0.52||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.52|-1.00|<0.001
91744041|NCT01456195|183382954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.01|TWO_SIDED|95.0|1.2|3.79||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||3.79|1.20|0.010
91744042|NCT01456195|183382954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.48|7.82||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||7.82|2.48|<0.001
91744043|NCT01456195|183382955|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.59||0.003|TWO_SIDED|95.0|-22.7|-4.6||Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.6|-22.7|0.003
91744044|NCT01456195|183382955|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.4|-13.2||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-13.2|-31.4|<0.001
91744045|NCT01456195|183382956|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.8|STANDARD_ERROR_OF_MEAN|17.17||0.1|TWO_SIDED|95.0|-63.2|5.7||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.7|-63.2|0.100
91535615|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.32||0.1496|TWO_SIDED|95.0|-0.17|1.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.09|-0.17|0.1496
91744046|NCT01456195|183382956|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|17.7||0.096|TWO_SIDED|95.0|-65.5|5.5||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.5|-65.5|0.096
91744047|NCT03304054|183382958|OTHER|||||||0.2196||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.2196
91744048|NCT03304054|183382959|OTHER|||||||0.3736||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.3736
91744049|NCT04683029|183382984|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|80.0|-13.8|-11.4|||MMRM model|||||-11.4|-13.8|< 0.001
91744050|NCT04683029|183382985|SUPERIORITY||LS Mean Difference|-12.0|||||TWO_SIDED|80.0|-13.3|-10.7||||||||-10.7|-13.3|
91744051|NCT04683029|183382986|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.3||||||Week 24||0.3|0.0|
91500735|NCT06092710|182871556|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.|||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000001
91531297|NCT00556374|182939179|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.504|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Cox Proportional Hazards Model|Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.|From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.|The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).||0.65|0.39|<0.0001
91744052|NCT04683029|183382986|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.2||||||Week 52||0.2|0.0|
91744053|NCT04683029|183382987|SUPERIORITY||Odds Ratio (OR)|203.2|||||TWO_SIDED|80.0|42.1|980.6||||||Week 24||980.6|42.1|
91744054|NCT04683029|183382987|SUPERIORITY||Odds Ratio (OR)|130.3|||||TWO_SIDED|80.0|28.2|601.9||||||Week 52||601.9|28.2|
91744055|NCT04683029|183382988|SUPERIORITY||LS Mean Difference|-47.2|||||TWO_SIDED|80.0|-96.8|2.4||||||Week 24||2.4|-96.8|
91744056|NCT04683029|183382988|SUPERIORITY||LS Mean difference|-14.2|||||TWO_SIDED|80.0|-57.2|28.8||||||Week 52||28.8|-57.2|
91744057|NCT04683029|183382989|SUPERIORITY||LS Mean Difference|0.0|||||TWO_SIDED|80.0|-1.7|1.6||||||Week 24||1.6|-1.7|
91744058|NCT04683029|183382989|SUPERIORITY||LS Mean Difference|0.1|||||TWO_SIDED|80.0|-1.4|1.7||||||Week 52||1.7|-1.4|
91744059|NCT04683029|183382990|SUPERIORITY||LS Mean Difference|-0.08|||||TWO_SIDED|80.0|-0.44|0.27||||||Week 24||0.27|-0.44|
91744060|NCT04683029|183382990|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|80.0|-0.29|0.71||||||Week 52||0.71|-0.29|
91744061|NCT04683029|183382991|SUPERIORITY||LS Mean Difference|-2.08|||||TWO_SIDED|80.0|-3.81|-0.34||||||Week 24||-0.34|-3.81|
91744062|NCT04683029|183382991|SUPERIORITY||LS Mean Difference|0.14|||||TWO_SIDED|80.0|-2.13|2.42||||||Week 52||2.42|-2.13|
91744063|NCT04683029|183382992|SUPERIORITY||LS Mean Difference|-4.9|||||TWO_SIDED|80.0|-5.7|-4.0||||||Week 24||-4.0|-5.7|
91744064|NCT04683029|183382992|SUPERIORITY||LS Mean Difference|-4.3|||||TWO_SIDED|80.0|-5.1|-3.5||||||Week 52||-3.5|-5.1|
91744065|NCT04683029|183382993|SUPERIORITY||LS Mean Difference|-0.4006|||||TWO_SIDED|80.0|-0.5344|-0.2668||||||Week 24||-0.2668|-0.5344|
91744066|NCT04683029|183382993|SUPERIORITY||LS Mean Difference|-0.2355|||||TWO_SIDED|80.0|-0.373|-0.098||||||Week 52||-0.0980|-0.3730|
91744067|NCT00066703|183383036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.717||||0.0002|TWO_SIDED|95.0|0.602|0.855|||Log Rank||T+OFS is the reference group in the estimation of the hazard ratio.|||0.855|0.602|.0002
91744068|NCT00066703|183383037|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.664|||<|0.0001|TWO_SIDED|95.0|0.548|0.804|||Log Rank||T+OFS is the reference group for the estimation of the hazard ratio.|||.804|.548|<.0001
91744069|NCT00066703|183383038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.777||||0.02|TWO_SIDED|95.0|0.624|0.967|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||0.967|0.624|0.02
91744070|NCT00066703|183383039|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.79|1.22|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||1.22|0.79|0.84
91744071|NCT01696968|183383040|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
91744072|NCT01696968|183383042|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
91744073|NCT01696968|183383044|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.98|1.12|||Poisson regression|||||1.12|0.98|
91744074|NCT01696968|183383048|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
91744075|NCT00734604|183383051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|95.0|0.04|0.19||p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.19|0.04|0.001
91744076|NCT00734604|183383052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.872|TWO_SIDED|95.0|-0.06|0.08||p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|LS Mean difference = Tadalafil OaD-Tadalafil PRN|||0.08|-0.06|0.872
91744077|NCT00734604|183383053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.1|0.2||p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.20|0.10|<0.001
91744078|NCT00734604|183383053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.395|TWO_SIDED|95.0|-0.03|0.07||p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.07|-0.03|0.395
91744079|NCT00734604|183383054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.36|-0.25||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.25|-0.36|<0.001
91744080|NCT00734604|183383054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.2|-0.08||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.08|-0.20|<0.001
91744081|NCT00734604|183383055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.43|-0.27||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.27|-1.43|0.004
91744082|NCT00734604|183383055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.29||0.007|TWO_SIDED|95.0|-1.37|-0.22||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.22|-1.37|0.007
91500736|NCT06092710|182871557|SUPERIORITY|||||||1.06e-06||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||Parametric tests on the prediction of patients' pathological status with SFI (Intermediate Final Score) For these analyses, as the SFI score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another.||||0.00000106
91744083|NCT00734604|183383056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.03|0.09||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.09|0.03|<0.001
91744084|NCT00734604|183383056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.06|0.12||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.12|0.06|<0.001
91744085|NCT00734604|183383057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.36||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.36|-0.91|<0.001
91744086|NCT00734604|183383057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.78|-0.23||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|||||-0.23|-0.78|<0.001
91744087|NCT00734604|183383058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.055|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.055
91744088|NCT00734604|183383058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.046|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.046
91744089|NCT00734604|183383059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.27||0.004|TWO_SIDED|95.0|1.16|6.17||p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||6.17|1.16|0.004
91500737|NCT06092710|182871557|SUPERIORITY|||||||48||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||"Parametric tests on the prediction of patients' pathological status with SFT score (Final Total score):~For these analyses, as SFT score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0000000048
91744090|NCT00734604|183383059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|1.27||0.006|TWO_SIDED|95.0|-6.05|-1.04||p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-1.04|-6.05|0.006
91744091|NCT00734604|183383061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.05||0.915|TWO_SIDED|95.0|-1.95|2.17||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||2.17|-1.95|0.915
91744092|NCT00734604|183383061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.212|TWO_SIDED|95.0|-3.35|0.74||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.74|-3.35|0.212
91744093|NCT00734604|183383062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.403|TWO_SIDED|95.0|-0.09|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.09|0.403
91744094|NCT00734604|183383062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.367|TWO_SIDED|95.0|-0.08|0.23||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.23|-0.08|0.367
91744095|NCT00734604|183383063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.06||0.002|TWO_SIDED|95.0|0.07|0.32||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.32|0.07|0.002
91744096|NCT00734604|183383063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.722|TWO_SIDED|95.0|-0.15|0.1||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.10|-0.15|0.722
91744097|NCT00734604|183383064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.65|-0.37||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.37|-0.65|<0.001
91744098|NCT00734604|183383064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.16|-0.43|<0.001
91744099|NCT00734604|183383065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.07|TWO_SIDED|95.0|-0.01|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.01|0.070
91744100|NCT00734604|183383065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.637|TWO_SIDED|95.0|-0.14|0.09||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.09|-0.14|0.637
91759520|NCT02391363|183411771|SUPERIORITY|||||||0.31||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.31
91500738|NCT06092710|182871557|SUPERIORITY||Odds Ratio (OR)|8.73||||7.7e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFI:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000077
91500739|NCT06092710|182871557|SUPERIORITY||Odds Ratio (OR)|9.37||||6.9e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFT:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000069
91500740|NCT06092710|182871558|SUPERIORITY|||||||0.0142266|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0142266
91500741|NCT06092710|182871558|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
91500742|NCT06092710|182871558|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
91500743|NCT06092710|182871558|SUPERIORITY|||||||0.9915779|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9915779
91500744|NCT06092710|182871558|SUPERIORITY|||||||0.9999943|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9999943
91500745|NCT06092710|182871558|SUPERIORITY|||||||0.9905111|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9905111
91500746|NCT05119569|182871559|SUPERIORITY||Rate Ratio|0.313||||0.0022|TWO_SIDED|95.0|0.149|0.658|||Negative Binomial Regression Model|||||0.658|0.149|0.0022
91500747|NCT05119569|182871560|SUPERIORITY||Rate Ratio|0.265||||0.0004|TWO_SIDED|95.0|0.128|0.55|||Negative Binomial Regression Model|||||0.550|0.128|0.0004
91500748|NCT05119569|182871561|SUPERIORITY||Odds Ratio (OR)|4.005||||0.0117|TWO_SIDED|95.0|1.317|13.078|||Logistic Regression Model|||||13.078|1.317|0.0117
91500749|NCT05119569|182871566|SUPERIORITY||Rate Ratio|0.78||||0.5889|TWO_SIDED|95.0|0.316|1.922|||Negative Binomial Regression Model|||||1.922|0.316|0.5889
91500750|NCT05119569|182871567|SUPERIORITY||Rate Ratio|0.076||||0.0011|TWO_SIDED|95.0|0.016|0.355|||Negative Binomial Regression Model|||||0.355|0.016|0.0011
91500751|NCT05119569|182871568|SUPERIORITY||Rate Ratio|0.104||||0.0038|TWO_SIDED|95.0|0.022|0.481|||Negative Binomial Regression Model|||||0.481|0.022|0.0038
91500752|NCT05119569|182871569|SUPERIORITY||Rate Ratio|0.512||||0.0958|TWO_SIDED|95.0|0.233|1.126|||Negative Binomial Regression Model|||||1.126|0.233|0.0958
91500753|NCT05119569|182871570|SUPERIORITY||Rate Ratio|0.105|||<|0.0001|TWO_SIDED|95.0|0.039|0.283|||Negative Binomial Regression Model|||||0.283|0.039|<0.0001
91500754|NCT05119569|182871571|SUPERIORITY||Rate Ratio|0.053||||0.0001|TWO_SIDED|95.0|0.012|0.233|||Negative Binomial Regression Model|||||0.233|0.012|0.0001
91500755|NCT03700671|182871594|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||A P-value of 0.05 was used as the threshold for significance|ANOVA|||A sample size of 38 using G\*Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and moderate intensity continuous training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at = 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study||||<0.01
91500756|NCT03700671|182871595|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||0.05 was used as a threshold for significance|ANOVA|||||||<0.01
91759521|NCT02391363|183411772|SUPERIORITY|||||||0.96||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.96
91760159|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|||||TWO_SIDED|95.0|3.29|9.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.04|3.29|
91500757|NCT04434092|182871624|NON_INFERIORITY|Non-inferiority is met when the lower limit of the 95% CI is greater than -20%.|Weighted Difference in Proportion|-2.8|||||TWO_SIDED|95.0|-15.67|11.14|||||95% CI for the difference in proportions of participants with TA is calculated by Stratified Newcombe CI method.|||11.14|-15.67|
91500758|NCT04434092|182871625|NON_INFERIORITY|Non-inferiority is met if the lower limit of the 95% confidence interval (CI) for the odds ratio is above 0.2|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.57|1.82||||||||1.82|0.57|
91500759|NCT04434092|182871626|NON_INFERIORITY|Non-inferiority is met if the upper limit (UL) of the 95% CI for the difference between crovalimab and eculizumab in the proportion of participants with BTH is less than the non-inferiority margin of 20%|Weighted Difference in Proportion|-3.9|||||TWO_SIDED|95.0|-14.82|5.26|||||95% CI for the difference in proportions of participants is calculated by Stratified Newcombe CI method.|||5.26|-14.82|
91744101|NCT02222909|183383083|OTHER|The significance of the difference-in-differences statistic was assessed using randomization inference, a non-parametric permutation test. Confidence intervals were determined by inversion of the test statistic.|Difference in differences|0.0182||||0.63|TWO_SIDED|95.0|-0.12|0.11||We calculated the proportion of permuted statistics with values higher in magnitude than that of the observed adjusted difference in differences (the p-value). We inverted the test statistic to determine confidence intervals.|Randomization inference||The estimation parameter is the difference between the average adjusted change in the monthly ED visits and hospital days from the pre- to post- intervention periods for the patients assigned to the iCBOs as compared to the cCBOs.|The difference between the average sum of the number of days spent in the hospital and ED visits in the past month, pre- and post-intervention, adjusted for pre- intervention variables, was calculated for each patients. The average change scores among patients assigned to each CBO defined the CBO-level outcomes. We calculated a weighted average of the CBO outcomes separately for the iCBOs and cCBOs, defining the difference-in-differences statistic as the difference between the two averages.||0.11|-0.12|0.63
91744102|NCT00117715|183383085|OTHER|||||||0.035||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(DM/DX) over time||||0.035
91744103|NCT00117715|183383086|OTHER|||||||0.194||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(3HM/DX) over time||||0.194
91744104|NCT00117715|183383087|OTHER|||||||0.831||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log ((AAMU+1MX+1MU)/1,7,U) over time||||0.831
91744105|NCT01460875|183383106|NON_INFERIORITY|The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||.22
91744106|NCT00654745|183383200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001|TWO_SIDED|95.0|-21.5|-18.4|||t-test, 2 sided|||||-18.4|-21.5|<0.0001
91744107|NCT00654745|183383201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.2|-10.3||24-hour mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.3|-12.2|<0.0001
91744108|NCT00654745|183383201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.5||daytime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.5|-12.9|<0.0001
91744109|NCT00654745|183383201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.0||nighttime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.0|-11.7|<0.0001
91744110|NCT00654745|183383201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.9|||<|0.0001|TWO_SIDED|95.0|-12.2|-9.7||last 6 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.7|-12.2|<0.0001
91760160|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.27|-1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.09|-6.27|
91760161|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|95.0|-5.07|0.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-5.07|
91760162|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|||||TWO_SIDED|95.0|-1.88|3.3||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.30|-1.88|
91500760|NCT04434092|182871627|NON_INFERIORITY|Non-inferiority is met when the lower limit of the 95% CI is greater than -20%.|Weighted Difference in Proportion|2.2|||||TWO_SIDED|95.0|-11.37|16.31|||||95% CI for the difference in proportions of participants is calculated by Stratified Newcombe CI method.|||16.31|-11.37|
91531298|NCT00556374|182939180|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|10.02|||<|0.0001|TWO_SIDED|95.0|9.04|11.01||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||11.01|9.04|<0.0001
91531299|NCT00556374|182939181|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|7.92|||<|0.0001|TWO_SIDED|95.0|6.87|8.97||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||8.97|6.87|<0.0001
91531300|NCT00556374|182939182|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|6.51|||<|0.0001|TWO_SIDED|95.0|5.62|7.39||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||7.39|5.62|<0.0001
91744111|NCT00654745|183383201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8||last 4 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.8|-12.4|<0.0001
91744112|NCT00654745|183383201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|||<|0.0001|TWO_SIDED|95.0|-13.1|-10.0||last 2 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.0|-13.1|<0.0001
91744113|NCT00654745|183383202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-18.9||daytime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-18.9|-22.6|<0.0001
91744114|NCT00654745|183383202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.5|||<|0.0001|TWO_SIDED|95.0|-20.4|-16.6||nighttime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.6|-20.4|<0.0001
91744115|NCT00654745|183383202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.9|||<|0.0001|TWO_SIDED|95.0|-20.7|-17.0||last 6 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.0|-20.7|<0.0001
91744116|NCT00654745|183383202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.1|||<|0.0001|TWO_SIDED|95.0|-21.1|-17.1||last 4 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.1|-21.1|<0.0001
91744117|NCT00654745|183383202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4||last 2 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.4|-21.7|<0.0001
91744118|NCT00654745|183383203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|||<|0.0001|TWO_SIDED|95.0|-12.0|-8.6||Change in mean seated systolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.6|-12.0|<0.0001
91744119|NCT00654745|183383203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.8|-16.1||Change in mean seated systolic blood pressure from baseline to week 6.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.1|-19.8|<0.0001
91744120|NCT00654745|183383203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-22.2|-17.8||Change in mean seated systolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.8|-22.2|<0.0001
91744121|NCT00654745|183383203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.7|||<|0.0001|TWO_SIDED|95.0|-25.7|-21.7||Change in mean seated systolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-21.7|-25.7|<0.0001
91744122|NCT00654745|183383203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.5|||<|0.0001|TWO_SIDED|95.0|-30.8|-26.2||Change in mean seated systolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-26.2|-30.8|<0.0001
91744123|NCT00654745|183383203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.1|||<|0.0001|TWO_SIDED|95.0|-33.3|-28.8||Change in mean seated systolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-28.8|-33.3|<0.0001
91744124|NCT00654745|183383204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.1||Change in mean seated diastolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-3.1|-5.1|<0.0001
91744125|NCT00654745|183383204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.2|||<|0.0001|TWO_SIDED|95.0|-9.4|-7.1||Change in mean seated diastolic blood pressure from baseline to week 6|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-7.1|-9.4|<0.0001
91744126|NCT00654745|183383204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7|||<|0.0001|TWO_SIDED|95.0|-10.9|-8.4||Change in mean seated diastolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.4|-10.9|<0.0001
91744127|NCT00654745|183383204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.5|-9.9||Change in mean seated diastolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.9|-12.5|<0.0001
91744128|NCT00654745|183383204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-13.1||Change in mean seated diastolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.1|-15.7|<0.0001
91500761|NCT04434092|182871628|NON_INFERIORITY|The non-inferiority margin was a -5 point score, where higher scores indicated less fatigue, and hence non-inferiority hypothesis was tested comparing the lower limit of the 95% CI for the difference with a non-inferiority margin of -5 points.|Difference in Adjusted mean|2.64|STANDARD_ERROR_OF_MEAN|0.993|||TWO_SIDED|95.0|0.68|4.6|||||Non-inferiority is met when the lower limit of the 95% CI is greater than -5.|||4.60|0.68|
91500762|NCT02879305|182871720|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.81|1.07|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|
91500763|NCT02879305|182871721|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.18|||||TWO_SIDED|95.0|0.12|0.24|||||Analysis of covariance (ANCOVA) model adjusted for treatment, Baseline Hgb, dialysis type and region along with 95% CI for treatment difference (daprodustat-rhEPO).|||0.24|0.12|
91744129|NCT00654745|183383204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||<|0.0001|TWO_SIDED|95.0|-16.5|-13.6||Change in mean seated diastolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.6|-16.5|<0.0001
91744130|NCT03086408|183383229|OTHER||Mean Difference (Final Values)|-4.0||||0.09|TWO_SIDED|95.0|-9.0|1.0|||t-test, 2 sided|||||1.00|-9.00|0.09
91744131|NCT03086408|183383230|OTHER||Mean Difference (Final Values)|0.9||||0.61|TWO_SIDED|95.0|-2.89|4.69|||t-test, 2 sided|||||4.69|-2.89|0.61
91744132|NCT03086408|183383231|OTHER||Mean Difference (Final Values)|-0.07||||0.78|TWO_SIDED|95.0|-0.61|0.47|||t-test, 2 sided|||||0.47|-0.61|0.78
91744133|NCT03086408|183383232|OTHER||Mean Difference (Final Values)|-0.4||||0.3|TWO_SIDED|95.0|-1.3|0.5|||t-test, 2 sided|||||0.50|-1.30|0.30
91744134|NCT03086408|183383233|OTHER||Mean Difference (Final Values)|0.1||||0.98|TWO_SIDED|95.0|-8.62|8.82|||t-test, 2 sided|||||8.82|-8.62|0.98
91500764|NCT02879305|182871722|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.156123|TWO_SIDED|95.0|0.81|1.07||The p-value was compared against 0.0125 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|0.156123
91744135|NCT03086408|183383234|OTHER||Mean Difference (Final Values)|0.6||||0.61|TWO_SIDED|95.0|-1.64|2.84|||t-test, 2 sided|||||2.84|-1.64|0.61
91744136|NCT03086408|183383235|OTHER||Mean Difference (Final Values)|13.7||||0.04|TWO_SIDED|95.0|0.63|26.77|||t-test, 2 sided|||||26.77|0.63|0.04
91744137|NCT03086408|183383236|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-2.8|2.8|||t-test, 2 sided|||||2.80|-2.80|1
91744138|NCT03086408|183383237|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-2.38|1.98|||t-test, 2 sided|||||1.98|-2.38|0.82
91744139|NCT03086408|183383238|OTHER||Mean Difference (Final Values)|-1.5||||0.37|TWO_SIDED|95.0|-5.29|2.29|||t-test, 2 sided|||||2.29|-5.29|0.37
91744140|NCT03470194|183383240|OTHER||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||||||=0.002
91744141|NCT01822899|183383241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|95.0|0.046|0.113|||ANCOVA|||||0.113|0.046|<0.001
91744142|NCT01450696|183383273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.2401|TWO_SIDED|95.0|0.86|1.78|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 milliliters per minute \[mL/min\] and greater than or equal to \[≥\] 60 mL/min). Hazard ratio was estimated by Cox regression.||1.78|0.86|0.2401
91744143|NCT01450696|183383273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.1285|TWO_SIDED|95.0|0.92|1.88|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||1.88|0.92|0.1285
91744144|NCT01450696|183383275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9931|TWO_SIDED|95.0|0.49|2.04|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.04|0.49|0.9931
91500765|NCT02879305|182871723|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.023539|TWO_SIDED|95.0|0.78|1.0||The p-value was compared against 0.006250 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.00|0.78|0.023539
91500766|NCT02879305|182871724|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.325797|TWO_SIDED|95.0|0.85|1.11||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.11|0.85|0.325797
91744145|NCT01450696|183383275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9458|TWO_SIDED|95.0|0.52|2.02|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.02|0.52|0.9458
91744146|NCT01450696|183383277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.6759|TWO_SIDED|95.0|0.63|2.02|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.02|0.63|0.6759
91500767|NCT02879305|182871725|SUPERIORITY||LS mean difference|-9.1||||0.026947|TWO_SIDED|95.0|-18.4|0.2||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|ANCOVA||Analysis was carried out by using ANCOVA model with terms for treatment, Baseline monthly IV iron dose, dialysis type and region.|||0.2|-18.4|0.026947
91500768|NCT02879305|182871726|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.3281|TWO_SIDED|95.0|0.82|1.13|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.13|0.82|0.3281
91500769|NCT02879305|182871727|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3553|TWO_SIDED|95.0|0.74|1.23|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.23|0.74|0.3553
91500770|NCT02879305|182871728|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0524|TWO_SIDED|95.0|0.63|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.63|0.0524
91744147|NCT01450696|183383277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.5764|TWO_SIDED|95.0|0.67|2.05|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.05|0.67|0.5764
91744148|NCT01450696|183383278|SUPERIORITY_OR_OTHER||Difference in response rates|-7.58||||0.5402|TWO_SIDED|95.0|-31.75|16.6|||Chi-squared|||The 95% CI for difference in response rates was constructed using the normal approximation to the binomial distribution.||16.60|-31.75|0.5402
91744149|NCT01450696|183383278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.28|1.96||||||||1.96|0.28|
91744150|NCT00853242|183383299|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0249
91500771|NCT02879305|182871729|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1927|TWO_SIDED|95.0|0.56|1.25|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.25|0.56|0.1927
91500772|NCT02879305|182871730|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0351|TWO_SIDED|95.0|0.8|1.01|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.01|0.80|0.0351
91531301|NCT00556374|182939183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.53||||0.0088|TWO_SIDED|95.0|0.33|0.85|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.85|0.33|0.0088
91744151|NCT00853242|183383299|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0001
91744152|NCT00853242|183383299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||<0.0001
91744153|NCT00853242|183383300|SUPERIORITY_OR_OTHER|||||||0.2647|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.2647
91744154|NCT00853242|183383300|SUPERIORITY_OR_OTHER|||||||0.7944|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.7944
91744155|NCT00853242|183383300|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.3724
91500773|NCT02879305|182871730|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
91500774|NCT02879305|182871730|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0158|TWO_SIDED|95.0|0.58|0.98|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.98|0.58|0.0158
91744156|NCT02516098|183383335|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference product (for Stage 1) was assessed on the basis of the point estimate of the geometric mean ratio for Cmax in relation to the bioequivalence range of 80.00% to 125.00%.|Geometric mean ratio (%): T/REF|87.52|||||TWO_SIDED|92.46|77.18|99.24|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||99.24|77.18|
91744157|NCT02516098|183383336|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference products for Stage 1 was assessed on the basis of the 92.46% confidence intervals for the geometric mean (test/reference) ratio for the AUC0-t in relation to the bioequivalence range of 80.00% to 125.00%, with a one-sided alpha of 0.0377.|Geometric mean ratio (%): T/REF|91.74|||||TWO_SIDED|92.46|83.51|100.78|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||100.78|83.51|
91744158|NCT02516098|183383337|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|91.66|||||TWO_SIDED|92.46|83.59|100.51|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||100.51|83.59|
91744159|NCT02516098|183383338|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|92.96|||||TWO_SIDED|92.46|81.94|105.47|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||105.47|81.94|
91744160|NCT01092780|183383339|SUPERIORITY_OR_OTHER||Difference in LS means|8.16|||||TWO_SIDED|95.0|6.11|10.2||||||Difference in least squares (LS) means||10.20|6.11|
91744161|NCT01092780|183383339|SUPERIORITY_OR_OTHER||Difference in LS means|8.11|||||TWO_SIDED|95.0|6.07|10.15||||||Difference in LS means||10.15|6.07|
91531302|NCT00556374|182939184|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.007|TWO_SIDED|95.0|0.34|0.84|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.84|0.34|0.0070
91500775|NCT02879305|182871730|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0981|TWO_SIDED|95.0|0.47|1.17|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.17|0.47|0.0981
91500776|NCT02879305|182871730|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
91744162|NCT01092780|183383340|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.1|-0.05||||||Difference in LS means||-0.05|-0.10|
91500777|NCT02879305|182871730|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0058|TWO_SIDED|95.0|0.6|0.94|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.94|0.60|0.0058
91744163|NCT01092780|183383340|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.09|-0.05||||||Difference in LS means||-0.05|-0.09|
91744164|NCT01092780|183383342|SUPERIORITY_OR_OTHER||Difference in LS means|-2.05|||||TWO_SIDED|90.0|-3.76|-0.35||||||Difference in LS means||-0.35|-3.76|
91744165|NCT01092780|183383342|SUPERIORITY_OR_OTHER||Difference in LS means|-2.1|||||TWO_SIDED|90.0|-3.79|-0.4||||||Difference in LS means||-0.40|-3.79|
91744166|NCT01092780|183383343|SUPERIORITY_OR_OTHER||Difference in LS means|10.21|||||TWO_SIDED|90.0|8.49|11.92||||||||11.92|8.49|
91744167|NCT01092780|183383344|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|90.0|-0.08|-0.05||||||Difference in LS means||-0.05|-0.08|
91500778|NCT02879305|182871731|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0872|TWO_SIDED|95.0|0.73|1.06|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.06|0.73|0.0872
91500779|NCT02879305|182871732|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.154|TWO_SIDED|95.0|0.87|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.87|0.1540
91500780|NCT02879305|182871733|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1244|TWO_SIDED|95.0|0.77|1.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.77|0.1244
91500781|NCT02879305|182871734|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.054|TWO_SIDED|95.0|0.81|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.81|0.0540
91500782|NCT02879305|182871735|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7658|TWO_SIDED|95.0|0.84|1.45|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.45|0.84|0.7658
91500783|NCT02879305|182871736|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0425|TWO_SIDED|95.0|0.69|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.69|0.0425
91500784|NCT02879305|182871737|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.12|||||TWO_SIDED|95.0|0.03|0.21||||||||0.21|0.03|
91500785|NCT02879305|182871738|SUPERIORITY||Difference in response rate|3.5||||0.0367|TWO_SIDED|95.0|-0.1|7.1|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for dialysis type, and region was used to compare the number of responders between the treatment groups.|||7.1|-0.1|0.0367
91500786|NCT02879305|182871739|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|1.06|||||TWO_SIDED|95.0|0.0|3.86|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||3.86|0.00|
91500787|NCT02879305|182871740|SUPERIORITY||Probability|0.52||||0.0805|TWO_SIDED|95.0|0.49|0.54|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.54|0.49|0.0805
91500788|NCT02879305|182871741|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.18|||||TWO_SIDED|95.0|0.28|4.05|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||4.05|0.28|
91500789|NCT02879305|182871742|SUPERIORITY||Probability|0.53||||0.0139|TWO_SIDED|95.0|0.5|0.55|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.55|0.50|0.0139
91500790|NCT02879305|182871743|SUPERIORITY||LS mean difference|0.33||||0.6551|TWO_SIDED|95.0|-1.28|1.94|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||1.94|-1.28|0.6551
91500791|NCT02879305|182871743|SUPERIORITY||LS mean difference|-0.46||||0.1586|TWO_SIDED|95.0|-1.36|0.44|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.44|-1.36|0.1586
91500792|NCT02879305|182871743|SUPERIORITY||LS mean difference|-0.18||||0.3646|TWO_SIDED|95.0|-1.2|0.84|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.84|-1.20|0.3646
91500793|NCT02879305|182871744|SUPERIORITY||LS mean difference|0.0||||0.5012|TWO_SIDED|95.0|-1.54|1.54|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.54|-1.54|0.5012
91500794|NCT02879305|182871744|SUPERIORITY||LS mean difference|0.45||||0.8451|TWO_SIDED|95.0|-0.42|1.31|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.31|-0.42|0.8451
91500795|NCT02879305|182871744|SUPERIORITY||LS mean difference|0.31||||0.7312|TWO_SIDED|95.0|-0.67|1.28|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.28|-0.67|0.7312
91500796|NCT02879305|182871745|SUPERIORITY||Ratio of exacerbation rate|1.0||||0.529|TWO_SIDED|95.0|0.91|1.11|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.11|0.91|0.5290
91744168|NCT01257230|183383345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.051||0.0085|TWO_SIDED|95.0|0.034|0.234|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.234|0.034|0.0085
91500797|NCT02879305|182871747|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5772|TWO_SIDED|95.0|0.71|1.52|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and region.|||1.52|0.71|0.5772
91500798|NCT02879305|182871748|SUPERIORITY||LS mean difference|0.29||||0.162|TWO_SIDED|95.0|-0.29|0.86|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-0.29|0.1620
91500799|NCT02879305|182871748|SUPERIORITY||LS mean difference|0.61||||0.018|TWO_SIDED|95.0|0.04|1.18|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.18|0.04|0.0180
91500800|NCT02879305|182871748|SUPERIORITY||LS mean difference|0.33||||0.153|TWO_SIDED|95.0|-0.31|0.97|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.97|-0.31|0.1530
91500801|NCT02879305|182871748|SUPERIORITY||LS mean difference|0.53||||0.0686|TWO_SIDED|95.0|-0.17|1.22|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.22|-0.17|0.0686
91500802|NCT02879305|182871749|SUPERIORITY||LS mean difference|-0.17||||0.6807|TWO_SIDED|95.0|-0.88|0.54|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.88|0.6807
91500803|NCT02879305|182871749|SUPERIORITY||LS mean difference|0.17||||0.3256|TWO_SIDED|95.0|-0.57|0.91|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.91|-0.57|0.3256
91500804|NCT02879305|182871749|SUPERIORITY||LS mean difference|-0.01||||0.5144|TWO_SIDED|95.0|-0.81|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.81|0.5144
91744169|NCT01257230|183383345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.05||0.0005|TWO_SIDED|95.0|0.076|0.272|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.272|0.076|0.0005
91744170|NCT01257230|183383346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.056||0.1307|TWO_SIDED|95.0|-0.025|0.194|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.194|-0.025|0.1307
91744171|NCT01257230|183383346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.032|TWO_SIDED|95.0|0.01|0.223|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.223|0.010|0.0320
91744172|NCT01257230|183383347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.057||0.1231|TWO_SIDED|95.0|-0.024|0.2|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.200|-0.024|0.1231
91744173|NCT01257230|183383347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.056||0.195|TWO_SIDED|95.0|-0.037|0.182|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.182|-0.037|0.1950
91744174|NCT01257230|183383348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.06||0.2921|TWO_SIDED|95.0|-0.055|0.181|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.181|-0.055|0.2921
91744175|NCT01257230|183383348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.059||0.5495|TWO_SIDED|95.0|-0.08|0.15|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.150|-0.080|0.5495
91744176|NCT01257230|183383349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0079|TWO_SIDED|95.0|0.034|0.225|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.225|0.034|0.0079
91744177|NCT01257230|183383349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.048||0.0002|TWO_SIDED|95.0|0.088|0.275|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.275|0.088|0.0002
91744178|NCT01257230|183383350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.054||0.0945|TWO_SIDED|95.0|-0.016|0.196|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.196|-0.016|0.0945
91744179|NCT01257230|183383350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.053||0.1755|TWO_SIDED|95.0|-0.032|0.175|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.175|-0.032|0.1755
91744180|NCT01257230|183383352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.092||0.976|TWO_SIDED|95.0|-0.184|0.178|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.178|-0.184|0.9760
91744181|NCT01257230|183383352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.09||0.9224|TWO_SIDED|95.0|-0.186|0.168|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.186|0.9224
91744182|NCT01257230|183383353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.083||0.7852|TWO_SIDED|95.0|-0.14|0.185|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.185|-0.140|0.7852
91744183|NCT01257230|183383353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.081||0.1649|TWO_SIDED|95.0|-0.046|0.271|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.271|-0.046|0.1649
91744184|NCT01257230|183383354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.143||0.8253|TWO_SIDED|95.0|-0.312|0.249|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.249|-0.312|0.8253
91744185|NCT01257230|183383354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.14||0.7559|TWO_SIDED|95.0|-0.232|0.319|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.319|-0.232|0.7559
91744186|NCT01257230|183383355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.087||0.0653|TWO_SIDED|95.0|-0.33|0.01|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.010|-0.330|0.0653
91744187|NCT01257230|183383355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.084||0.2516|TWO_SIDED|95.0|-0.263|0.069|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.069|-0.263|0.2516
91744188|NCT01257230|183383357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.095||0.12|TWO_SIDED|95.0|-0.333|0.038|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.038|-0.333|0.1200
91500805|NCT02879305|182871749|SUPERIORITY||LS mean difference|-0.6||||0.912|TWO_SIDED|95.0|-1.47|0.27|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.27|-1.47|0.9120
91744189|NCT01257230|183383357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.092||0.5589|TWO_SIDED|95.0|-0.235|0.127|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.127|-0.235|0.5589
91744190|NCT01257230|183383359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.4023|TWO_SIDED|95.0|0.21|1.87|||Regression, Cox|||||1.87|0.21|0.4023
91744191|NCT01257230|183383359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.062|TWO_SIDED|95.0|0.05|1.08|||Regression, Cox|||||1.08|0.05|0.0620
91744192|NCT01257230|183383360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.87|TWO_SIDED|95.0|0.65|1.66|||Regression, Cox|||||1.66|0.65|0.8700
91744193|NCT01257230|183383360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4198|TWO_SIDED|95.0|0.51|1.33|||Regression, Cox|||||1.33|0.51|0.4198
91500806|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.25||||0.7432|TWO_SIDED|95.0|-0.99|0.5|||MMRM||Bodily pain,Week8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.50|-0.99|0.7432
91744194|NCT01988662|183383393|NON_INFERIORITY_OR_EQUIVALENCE|"H0: There is no difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept.~HA: There is a difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept."|Mean Difference (Net)|62.57|STANDARD_ERROR_OF_MEAN|24.639||0.012|TWO_SIDED|95.0|13.96|111.17|||Mixed Models Analysis|||H0: μR = μA versus HA: μR ≠ μA||111.17|13.96|0.012
91744195|NCT02300558|183383395|OTHER|||||||0.0087|||||||paired t- test|||Based on a 2-sided, paired t-test ( α = 0.05), and a standard deviation (SD) of 30 msec, a sample size of 40 participants provided greater than 95% power assuming a difference in mean daytime QTcF interval (AUC0-6/6) as measured by standard 12-lead ECG between baseline and Week 24 of 20 msec. The null hypothesis was that the mean difference between the baseline and Week 24 mean daytime QTcF interval was zero.||||0.0087
91744196|NCT01471028|183383399|SUPERIORITY||Hazard Ratio (HR)|1.027||||0.904|TWO_SIDED|95.0|0.689|1.53|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.53|0.689|0.904
91744197|NCT01471028|183383400|SUPERIORITY|||||||0.737|||||||Chi-squared|||||||0.737
91744198|NCT01471028|183383401|SUPERIORITY||Hazard Ratio (HR)|1.315||||0.168|TWO_SIDED|95.0|0.886|1.952|||Log Rank|||||1.952|0.886|0.168
91744199|NCT01471028|183383402|SUPERIORITY||Hazard Ratio (HR)|0.283||||0.007|TWO_SIDED|95.0|0.109|0.732|||Log Rank|||||0.732|0.109|0.007
91744200|NCT03115827|183383429|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
91744201|NCT02027311|183383434|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0||||For two-sided tests, p \< 0.05 was considered statistically significant.|Regression, Logistic|Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).||If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.05
91744202|NCT02027311|183383435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.09||||0.002|TWO_SIDED|95.0|2.41|50.94||Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).|Regression, Logistic|||All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p \< 0.05 was considered statistically significant.||50.94|2.41|0.002
91744203|NCT01825512|183383455|NON_INFERIORITY|Deferiprone was declared non inferior to Deferasirox if the lower limit of the 95% confidence interval for the difference in the proportion of successful chelation in the two groups is above -12.5%.|Treatment success rate|-12.5|||||ONE_SIDED|95.0|-12.5||||||||||-12.5|
91744204|NCT01825512|183383456|OTHER|GLM model|Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|1.18||0.074|TWO_SIDED|95.0|-0.213|4.468|||ANCOVA|||||4.468|-0.213|0.074
91500807|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.58||||0.0631|TWO_SIDED|95.0|-0.16|1.33|||MMRM||Bodily pain,Week12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.33|-0.16|0.0631
91744205|NCT01825512|183383457|OTHER|GLM Analysis|Mean Difference (Final Values)|-0.633|STANDARD_ERROR_OF_MEAN|1.741||0.717|TWO_SIDED|95.0|-4.085|2.819|||ANCOVA|||||2.819|-4.085|0.717
91500808|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.04||||0.4604|TWO_SIDED|95.0|-0.79|0.87|||MMRM||Bodily pain,Week28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.87|-0.79|0.4604
91500809|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.28||||0.2688|TWO_SIDED|95.0|-0.6|1.15|||MMRM||Bodily pain,Week52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.15|-0.60|0.2688
91744206|NCT01825512|183383458|NON_INFERIORITY|Non inferiority of Deferiprone to Deferasirox is tested considering a non-inferiority margin of 400 ng/mL.|Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|164.734||0.997|TWO_SIDED|95.0|-323.58|324.781|||GLM|||||324.781|-323.580|0.997
91744207|NCT02091362|183383459|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.11|3.4|||Mixed Models Analysis|||||3.40|1.11|<.001
91744208|NCT02091362|183383460|SUPERIORITY_OR_OTHER||LS Mean Difference|1.37|||<|0.01|TWO_SIDED|95.0|0.66|2.08|||Mixed Models Analysis|||||2.08|0.66|<0.01
91744209|NCT00286091|183383467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0284|TWO_SIDED|95.0|0.73|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|Primary and secondary endpoint analyses were conducted hierarchically. To preserve an overall type I error rate of 0.05, a 0.0488 2-sided test of bone metastasis-free survival was performed. If superiority of denosumab over placebo was established, time to first bone metastasis was tested with a 2-sided significance level of 0.050. If superiority of denosumab over placebo was also established, overall survival time was tested at a 2-sided significance level of 0.050.||0.98|0.73|0.0284
91500810|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.26||||0.1918|TWO_SIDED|95.0|-0.32|0.84|||MMRM||General health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.84|-0.32|0.1918
91500811|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.45||||0.0677|TWO_SIDED|95.0|-0.14|1.04|||MMRM||General health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.04|-0.14|0.0677
91744210|NCT00286091|183383468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0317|TWO_SIDED|95.0|0.71|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||0.98|0.71|0.0317
91744211|NCT00286091|183383469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9125|TWO_SIDED|95.0|0.85|1.2|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||1.20|0.85|0.9125
91744212|NCT01032603|183383498|SUPERIORITY||Difference in percentage of participants|9.0||||0.24|TWO_SIDED|95.0|-6.0|23.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=46%, RR group=37%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||23|-6|0.24
91744213|NCT01032603|183383499|SUPERIORITY||Difference in percentage of participants|8.0||||0.25|TWO_SIDED|95.0|-6.0|21.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=34%, RR group=26%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||21|-6|0.25
91744214|NCT01032603|183383500|SUPERIORITY||Difference in percentage of participants|-7.0||||0.06|TWO_SIDED|95.0|-14.0|0.23|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=3%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||0.23|-14|0.06
91500812|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.33||||0.8386|TWO_SIDED|95.0|-0.98|0.32|||MMRM||General health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.32|-0.98|0.8386
91500813|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.29||||0.7928|TWO_SIDED|95.0|-0.99|0.41|||MMRM||General health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.41|-0.99|0.7928
91500814|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.04||||0.4537|TWO_SIDED|95.0|-0.63|0.71|||MMRM||Mental health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.71|-0.63|0.4537
91744215|NCT01032603|183383501|SUPERIORITY||Difference in percentage of participants|4.0||||0.36|TWO_SIDED|95.0|-5.0|14.0|||Z test||Proportion of participants meeting criteria by 3 yrs was obtained by KM method. BLR group=14%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||14|-5|0.36
91744216|NCT01032603|183383503|SUPERIORITY|||||||0.44|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).||||0.44
91744217|NCT01032603|183383506|SUPERIORITY|||||||0.64|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).||||0.64
91744218|NCT01032603|183383509|SUPERIORITY|||||||0.21|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.21
91744219|NCT01032603|183383512|SUPERIORITY|||||||0.38|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.38
91744220|NCT01032603|183383515|SUPERIORITY|||||||0.93|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.93
91744221|NCT01032603|183383518|SUPERIORITY|||||||0.82|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.82
91500815|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.05||||0.5548|TWO_SIDED|95.0|-0.74|0.65|||MMRM||Mental health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.65|-0.74|0.5548
91744222|NCT01032603|183383520|SUPERIORITY|||||||0.3||||||Child 5 to 7 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.30
91744223|NCT01032603|183383520|SUPERIORITY|||||||0.77||||||Child 8 to 13 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.77
91744224|NCT01032603|183383520|SUPERIORITY|||||||0.51||||||Parent Proxy IXTQ|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.51
91744225|NCT01032603|183383520|SUPERIORITY|||||||0.42||||||Parent Psychosocial|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.42
91744226|NCT01032603|183383520|SUPERIORITY|||||||0.68||||||Parent Function|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.68
91744227|NCT01032603|183383520|SUPERIORITY|||||||0.64||||||Parent Surgical|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.64
91744228|NCT01032603|183383521|SUPERIORITY||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.0|13.0||||||"The cumulative proportion of participants with re-operation by 3 years was obtained using the Kaplan-Meier (K-M) method.~A treatment-group difference and a corresponding 95% confidence interval were calculated.~Treatment-group differences were calculated as BLR minus RR."||13|-2|
91744229|NCT01032603|183383522|SUPERIORITY||Difference in percentage of participants|-15.0|||||TWO_SIDED|95.0|-30.0|-0.0003||||||All treatment-group differences were calculated as the BLRc group minus the R\&R group. A treatment-group difference and a corresponding 95% confidence interval were calculated.||-.0003|-30|
91744230|NCT01032603|183383523|SUPERIORITY||Difference in percentage of participants|12.0|||||TWO_SIDED|95.0|-1.0|25.0||||||The proportion of participants with suboptimal surgical outcome at 3 years was compared between treatment groups using Barnard's exact test, and an exact 95% CI on the treatment-group difference was calculated using Farrington-Manning scores.||25|-1|
91744231|NCT01813058|183383533|SUPERIORITY||Mean Difference (Final Values)|195.0|||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91744232|NCT00923351|183383561|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Fisher Exact|||||||0.043
91744233|NCT01579565|183383573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.049||0.0001||95.0|0.494|0.686||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||0.686|0.494|0.0001
91744234|NCT01579565|183383574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.192||0.0002||95.0|-6.917|-2.244||p-value is based on the generalized CMH test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||-2.244|-6.917|0.0002
91744235|NCT01579565|183383575|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test.|Chi-squared|||||||0.0001
91744236|NCT01579565|183383576|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test|Chi-squared|||||||0.0001
91744237|NCT01579565|183383577|SUPERIORITY_OR_OTHER|||||||0.076||||||Chi-square test|Chi-squared|||||||0.0760
91531303|NCT00556374|182939185|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.0515|TWO_SIDED|95.0|0.66|1.0|||Cox Proportional Hazards Model|Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).|From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.|||1.00|0.66|0.0515
91744238|NCT01579565|183383578|SUPERIORITY_OR_OTHER|||||||0.0806||||||Chi-square test|Chi-squared|||||||0.0806
91744239|NCT01579565|183383579|SUPERIORITY_OR_OTHER|||||||0.0002||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0002
91744240|NCT01579565|183383580|SUPERIORITY_OR_OTHER|||||||0.3923||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3923
91744241|NCT01579565|183383581|SUPERIORITY_OR_OTHER|||||||0.006||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0060
91744242|NCT01579565|183383582|SUPERIORITY_OR_OTHER|||||||0.3286||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.3286
91744243|NCT01579565|183383583|SUPERIORITY_OR_OTHER|||||||0.2361||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata.|Wilcoxon rank-sum test|||||||0.2361
91744244|NCT01380535|183383585|OTHER|||||||0.373|||||||Fisher Exact|||||||0.373
91744245|NCT00394251|183383598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.641
91744246|NCT00394251|183383604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0|||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.323
91744247|NCT01667224|183383636|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
91500816|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.13||||0.3626|TWO_SIDED|95.0|-0.61|0.88|||MMRM||Mental health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.88|-0.61|0.3626
91744248|NCT01667224|183383637|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
91744249|NCT01667224|183383638|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
91744250|NCT01667224|183383639|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
91744251|NCT01843673|183383752|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
91744252|NCT01843673|183383752|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
91744253|NCT03928418|183383809|SUPERIORITY||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.1|4.9||p-value comparing live call booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||4.9|2.1|<0.001
91744254|NCT03928418|183383809|SUPERIORITY||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|2.2|5.1||p-value comparing technology booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||5.1|2.2|<0.001
91744255|NCT03928418|183383810|SUPERIORITY||Mean Difference (Net)|36.4||||0.643|TWO_SIDED|95.0|-117.5|190.3||p-value comparing live call booster arm to SOC arm: p = 0.643|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||190.3|-117.5|0.643
91744256|NCT03928418|183383810|SUPERIORITY||Mean Difference (Net)|-30.9||||0.711|TWO_SIDED|95.0|-194.8|132.9||p-value comparing technology booster arm to SOC arm: p = 0.711|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||132.9|-194.8|0.711
91744257|NCT03928418|183383811|SUPERIORITY||Mean Difference (Net)|-2.3||||0.515|TWO_SIDED|95.0|-9.3|4.7||p-value comparing live call booster arm to SOC: p = 0.515|Regression, Logistic||SOC minus live call booster arm presented here.|||4.7|-9.3|0.515
91744258|NCT03928418|183383811|SUPERIORITY||Mean Difference (Net)|-0.9||||0.801|TWO_SIDED|95.0|-8.3|6.4||p-value comparing technology booster arm to SOC: p = 0.801|Regression, Logistic||SOC minus technology booster arm presented here.|||6.4|-8.3|0.801
91744259|NCT03928418|183383812|SUPERIORITY||Mean Difference (Net)|28.9|||<|0.001|TWO_SIDED|95.0|17.0|40.7||p-value comparing live call booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||40.7|17.0|<0.001
91744260|NCT03928418|183383812|SUPERIORITY||Mean Difference (Net)|24.9|||<|0.001|TWO_SIDED|95.0|13.0|36.8||p-value comparing technology booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||36.8|13.0|<0.001
91744261|NCT03928418|183383813|SUPERIORITY||Mean Difference (Net)|4.4||||0.002|TWO_SIDED|95.0|1.6|7.3||p-value comparing live call booster arm to SOC: p = 0.002|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm presented here.|||7.3|1.6|0.002
91500817|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.81||||0.9721|TWO_SIDED|95.0|-1.64|0.02|||MMRM||Mental health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-1.64|0.9721
91500818|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.09||||0.5789|TWO_SIDED|95.0|-0.96|0.78|||MMRM||Role-emotional,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.96|0.5789
91500819|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.37||||0.2054|TWO_SIDED|95.0|-0.51|1.24|||MMRM||Role-emotional,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.51|0.2054
91500820|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.05||||0.5389|TWO_SIDED|95.0|-0.98|0.89|||MMRM||Role-emotional,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.89|-0.98|0.5389
91531304|NCT00556374|182939186|SUPERIORITY|Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.808|||||TWO_SIDED|95.0|0.654|0.997|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.|||0.997|0.654|
91744262|NCT03928418|183383813|SUPERIORITY||Mean Difference (Net)|4.3||||0.003|TWO_SIDED|95.0|1.5|7.2||p-value comparing technology booster arm to SOC: p = 0.003|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm presented here.|||7.2|1.5|0.003
91500821|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.09||||0.4289|TWO_SIDED|95.0|-0.91|1.09|||MMRM||Role-emotional,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.09|-0.91|0.4289
91531305|NCT00556374|182939187|SUPERIORITY|Analysis of OS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.635|1.013|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer overall survival time for denosumab relative to placebo.|||1.013|0.635|
91744263|NCT03928418|183383815|SUPERIORITY||Mean Difference (Net)|-0.8||||0.61|TWO_SIDED|95.0|-3.8|2.2||p-value comparing live call booster arm to SOC arm: p = 0.610.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||2.2|-3.8|0.610
91744264|NCT03928418|183383815|SUPERIORITY||Mean Difference (Net)|-1.1||||0.474|TWO_SIDED|95.0|-4.1|1.9||p-value comparing technology booster arm to SOC arm: p = 0.474.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||1.9|-4.1|0.474
91744265|NCT05319600|183383822|SUPERIORITY|treatment group as predictor baseline-residualized week 12 scores in linear regression|Slope|129.2|STANDARD_ERROR_OF_MEAN|73.96|<|0.05|TWO_SIDED|95.0|-22.52|280.98|||Regression, Linear||Control coded as 0 and treatment as 1|||280.98|-22.52|<0.05
91744266|NCT00904670|183383823|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-12.46|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-14.75|-10.17|||ANOVA|||Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-10.17|-14.75|<0.0001
91744267|NCT00904670|183383824|SUPERIORITY_OR_OTHER||LS mean difference|-6.32|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-8.53|-4.11|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-4.11|-8.53|<0.0001
91744268|NCT00904670|183383824|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|95.0|-12.04|-7.91|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-7.91|-12.04|<0.0001
91744269|NCT00904670|183383824|SUPERIORITY_OR_OTHER||LS mean difference|-9.33|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|95.0|-11.92|-6.75|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-6.75|-11.92|<0.0001
91744270|NCT00904670|183383824|SUPERIORITY_OR_OTHER||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.11||0.0016|TWO_SIDED|95.0|-6.04|-1.54|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.54|-6.04|0.0016
91500822|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.08||||0.4096|TWO_SIDED|95.0|-0.6|0.75|||MMRM||Role-physical,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.75|-0.60|0.4096
91500823|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.4||||0.1196|TWO_SIDED|95.0|-0.27|1.07|||MMRM||Role-physical,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.07|-0.27|0.1196
91531306|NCT01053637|182939246|SUPERIORITY|||||||0.05||||||Pain at 5 minutes using Children's Hospital of Eastern Ontario Pain Scale validated in the younger population. Using a 2-point difference in CHEOPS pain scale as a clinically significant change, 34 patients were required in the younger 2- to 7 group.|Fisher Exact|||Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest or worst pain.||||0.05
91500824|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.3||||0.2093|TWO_SIDED|95.0|-0.42|1.01|||MMRM||Role-physical,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.01|-0.42|0.2093
91500825|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.39||||0.1674|TWO_SIDED|95.0|-0.4|1.19|||MMRM||Role-physical,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.19|-0.40|0.1674
91500826|NCT02879305|182871750|SUPERIORITY||LS mean difference|-0.14||||0.6585|TWO_SIDED|95.0|-0.82|0.54|||MMRM||Social fun, Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.82|0.6585
91500827|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.69||||0.0293|TWO_SIDED|95.0|-0.03|1.4|||MMRM||Social fun, Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.40|-0.03|0.0293
91531307|NCT01053637|182939247|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.||||0.05
91531308|NCT02404493|182939249|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91744271|NCT00904670|183383824|SUPERIORITY_OR_OTHER||LS mean difference|-4.77|STANDARD_ERROR_OF_MEAN|1.4||0.0016|TWO_SIDED|95.0|-7.61|-1.94|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.94|-7.61|0.0016
91744272|NCT00904670|183383825|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.38||0.0051|TWO_SIDED|95.0|-1.88|-0.36|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.36|-1.88|0.0051
91744273|NCT00904670|183383825|SUPERIORITY_OR_OTHER||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.23|-0.95|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.95|-2.23|<0.0001
91500828|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.33||||0.2057|TWO_SIDED|95.0|-0.45|1.11|||MMRM||Social fun, Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.11|-0.45|0.2057
91500829|NCT02879305|182871750|SUPERIORITY||LS mean difference|0.02||||0.4849|TWO_SIDED|95.0|-0.86|0.9|||MMRM||Social fun, Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.90|-0.86|0.4849
91531309|NCT02404493|182939249|SUPERIORITY_OR_OTHER|||||||0.023||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.023
91531310|NCT02404493|182939249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|422.81|STANDARD_ERROR_OF_MEAN|122.905||0.003|TWO_SIDED|95.0|166.435|679.186||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||679.186|166.435|0.003
91500830|NCT02879305|182871751|SUPERIORITY||LS mean difference|0.03||||0.4621|TWO_SIDED|95.0|-0.58|0.64|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.64|-0.58|0.4621
91500831|NCT02879305|182871751|SUPERIORITY||LS mean difference|0.35||||0.1439|TWO_SIDED|95.0|-0.29|0.98|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.98|-0.29|0.1439
91500832|NCT02879305|182871751|SUPERIORITY||LS mean difference|0.24||||0.2392|TWO_SIDED|95.0|-0.43|0.92|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.92|-0.43|0.2392
91500833|NCT02879305|182871751|SUPERIORITY||LS mean difference|-0.15||||0.6545|TWO_SIDED|95.0|-0.9|0.6|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.60|-0.90|0.6545
91531311|NCT02404493|182939250|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91500834|NCT02879305|182871752|SUPERIORITY||LS mean difference|0.64||||0.029|TWO_SIDED|95.0|-0.02|1.31|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.31|-0.02|0.0290
91500835|NCT02879305|182871752|SUPERIORITY||LS mean difference|0.56||||0.0509|TWO_SIDED|95.0|-0.11|1.24|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.11|0.0509
91500836|NCT02879305|182871752|SUPERIORITY||LS mean difference|0.77||||0.0237|TWO_SIDED|95.0|0.01|1.53|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.53|0.01|0.0237
91500837|NCT02879305|182871752|SUPERIORITY||LS mean difference|0.58||||0.0828|TWO_SIDED|95.0|-0.24|1.39|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.39|-0.24|0.0828
91500838|NCT02879305|182871753|SUPERIORITY||LS mean difference|0.0003||||0.4939|TWO_SIDED|95.0|-0.0326|0.0331|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0331|-0.0326|0.4939
91744274|NCT00904670|183383825|SUPERIORITY_OR_OTHER||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.54||0.0001|TWO_SIDED|95.0|-3.37|-1.2|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.20|-3.37|0.0001
91744275|NCT00904670|183383825|SUPERIORITY_OR_OTHER||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.51||0.0055|TWO_SIDED|95.0|-2.52|-0.47|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.47|-2.52|0.0055
91500839|NCT02879305|182871754|SUPERIORITY||LS mean difference|-1.8||||0.9292|TWO_SIDED|95.0|-4.2|0.6|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.6|-4.2|0.9292
91500840|NCT02879305|182871755|SUPERIORITY||LS mean difference|-0.06||||0.0428|TWO_SIDED|95.0|-0.13|0.01|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.01|-0.13|0.0428
91500841|NCT02879305|182871755|SUPERIORITY||LS mean difference|-0.04||||0.1155|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1155
91500842|NCT02879305|182871755|SUPERIORITY||LS mean difference|-0.04||||0.1426|TWO_SIDED|95.0|-0.12|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.12|0.1426
91500843|NCT02879305|182871755|SUPERIORITY||LS mean difference|-0.05||||0.1152|TWO_SIDED|95.0|-0.13|0.03|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.13|0.1152
91531312|NCT02404493|182939250|SUPERIORITY_OR_OTHER|||||||0.754||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.754
91500844|NCT00613938|182871759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.4|STANDARD_ERROR_OF_MEAN|11.9|<|0.001||95.0|39.01|85.73||Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.|ANCOVA||The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.|Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.||85.73|39.01|<0.001
91500845|NCT00312494|182871783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1077||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint||||0.1077
91500846|NCT00312494|182871783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.||||0.4274
91744276|NCT00904670|183383825|SUPERIORITY_OR_OTHER||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.1977|TWO_SIDED|95.0|-1.38|0.29|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.29|-1.38|0.1977
91744277|NCT00904670|183383825|SUPERIORITY_OR_OTHER||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.43||0.0491|TWO_SIDED|95.0|-1.76|0.0|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.00|-1.76|0.0491
91744278|NCT00904670|183383826|SUPERIORITY_OR_OTHER||LS mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.36|-1.02|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.02|-2.36|<0.0001
91744279|NCT00904670|183383826|SUPERIORITY_OR_OTHER||LS mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.5|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.50|<0.0001
91744280|NCT00904670|183383826|SUPERIORITY_OR_OTHER||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.77|-2.13|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.13|-3.77|<0.0001
91500847|NCT00312494|182871784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4025
91500848|NCT00312494|182871784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.2830
91500849|NCT00312494|182871784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4125||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4125
91500850|NCT00312494|182871784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1527||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.1527
91500851|NCT00312494|182871785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0101||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0101
91531313|NCT02404493|182939250|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|52.3|STANDARD_ERROR_OF_MEAN|19.21||0.013|TWO_SIDED|95.0|12.23|92.373||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||92.373|12.230|0.013
91500852|NCT00312494|182871785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0694
91500853|NCT00312494|182871785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0183
91500854|NCT00312494|182871785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0176
91500855|NCT00312494|182871785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2302||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.2302
91500856|NCT00312494|182871785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0796||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0796
91500857|NCT00312494|182871786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6191||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6191
91500858|NCT00312494|182871786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5629||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.5629
91500859|NCT00312494|182871786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.9049
91531314|NCT02404493|182939251|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91500860|NCT00312494|182871786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7153||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.7153
91531315|NCT02404493|182939251|SUPERIORITY_OR_OTHER|||||||0.271||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.271
91500861|NCT00312494|182871786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.2420
91500862|NCT00312494|182871786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6121||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6121
91500863|NCT00312494|182871787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6138||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6138
91500864|NCT00312494|182871787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6536||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6536
91500865|NCT00312494|182871787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4758||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.4758
91500866|NCT00312494|182871787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7581||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.7581
91531316|NCT02404493|182939251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.95|STANDARD_ERROR_OF_MEAN|48.21||0.002|TWO_SIDED|95.0|67.046|268.854||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||268.854|67.046|0.002
91531317|NCT02404493|182939252|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
91531318|NCT02404493|182939252|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.260
91500867|NCT00312494|182871787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2221||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.2221
91500868|NCT00312494|182871787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5665||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.5665
91500869|NCT00312494|182871788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.1063
91500870|NCT00312494|182871788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2499||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.2499
91531319|NCT02404493|182939252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|221.97|STANDARD_ERROR_OF_MEAN|100.674||0.04|TWO_SIDED|95.0|11.254|432.68||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||432.680|11.254|0.040
91531320|NCT02404493|182939253|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91531321|NCT02404493|182939253|SUPERIORITY_OR_OTHER|||||||0.22||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.220
91744281|NCT00904670|183383826|SUPERIORITY_OR_OTHER||LS mean difference|-2.49|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.33|-1.66|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.66|-3.33|<0.0001
91744282|NCT00904670|183383826|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.4||0.0035|TWO_SIDED|95.0|-2.07|-0.44|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.44|-2.07|0.0035
91744283|NCT00904670|183383826|SUPERIORITY_OR_OTHER||LS mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.53||0.0109|TWO_SIDED|95.0|-2.51|-0.35|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.35|-2.51|0.0109
91500871|NCT00312494|182871788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0876||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.0876
91744284|NCT00904670|183383827|SUPERIORITY_OR_OTHER||LS mean difference|25.61|STANDARD_ERROR_OF_MEAN|4.61|<|0.0001|TWO_SIDED|95.0|16.26|34.96|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||34.96|16.26|<0.0001
91500872|NCT00312494|182871788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3623||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.3623
91500873|NCT00312494|182871788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4686||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.4686
91531322|NCT02404493|182939253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|194.0|STANDARD_ERROR_OF_MEAN|68.461||0.011|TWO_SIDED|95.0|50.712|337.291||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||337.291|50.712|0.011
91531323|NCT02404493|182939254|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
91531324|NCT02404493|182939254|SUPERIORITY_OR_OTHER|||||||0.06||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.060
91500874|NCT00312494|182871788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2202||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.2202
91500875|NCT00312494|182871789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0728||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.0728
91500876|NCT00312494|182871789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3174||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.3174
91500877|NCT00312494|182871790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.4460
91500878|NCT00312494|182871790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3253||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.3253
91500879|NCT01985581|182871809|SUPERIORITY_OR_OTHER||LS mean difference|-3.0||||0.0392|TWO_SIDED|95.0|-5.9|-0.2|||ANOVA|||||-0.2|-5.9|0.0392
91744285|NCT00904670|183383827|SUPERIORITY_OR_OTHER||LS mean difference|37.1|STANDARD_ERROR_OF_MEAN|5.21|<|0.0001|TWO_SIDED|95.0|26.54|47.66|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||47.66|26.54|<0.0001
91500880|NCT01985581|182871810|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.894|TWO_SIDED|95.0|-4.0|4.6|||ANOVA|||||4.6|-4.0|0.894
91531325|NCT02404493|182939254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.9|STANDARD_ERROR_OF_MEAN|79.567||0.107|TWO_SIDED|95.0|-32.266|302.063||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||302.063|-32.266|0.107
91500881|NCT01985581|182871811|SUPERIORITY_OR_OTHER||LS mean difference|-6.2||||0.0001|TWO_SIDED|95.0|-9.1|-3.2|||ANOVA|||||-3.2|-9.1|0.0001
91500882|NCT01985581|182871813|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.8706|TWO_SIDED|95.0|-3.2|3.7|||ANOVA|||||3.7|-3.2|0.8706
91500883|NCT02057198|182871816|SUPERIORITY||Slope|-0.15||||0.52|TWO_SIDED|95.0|-0.34|0.05||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.05|-0.34|0.52
91744286|NCT00904670|183383827|SUPERIORITY_OR_OTHER||LS mean difference|45.77|STANDARD_ERROR_OF_MEAN|7.35|<|0.0001|TWO_SIDED|95.0|30.89|60.65|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||60.65|30.89|<0.0001
91744287|NCT00904670|183383827|SUPERIORITY_OR_OTHER||LS mean difference|35.46|STANDARD_ERROR_OF_MEAN|6.57|<|0.0001|TWO_SIDED|95.0|22.14|48.78|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||48.78|22.14|<0.0001
91744288|NCT00904670|183383827|SUPERIORITY_OR_OTHER||LS mean difference|14.86|STANDARD_ERROR_OF_MEAN|5.86||0.0155|TWO_SIDED|95.0|3.0|26.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||26.73|3.00|0.0155
91500884|NCT02057198|182871816|SUPERIORITY||Slope|-0.17||||0.66|TWO_SIDED|95.0|-0.69|0.35||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.35|-0.69|0.66
91500885|NCT02057198|182871817|SUPERIORITY||||||<|0.001|||||||Chi square (2 proportion test)|||||||<0.001
91500886|NCT02057198|182871817|SUPERIORITY|||||||0.01|||||||Chi square (2 proportion test)|||||||0.01
91500887|NCT02057198|182871818|SUPERIORITY|||||||0.99|||||||Chi square (2 proportion test)|||||||0.99
91500888|NCT02057198|182871818|SUPERIORITY|||||||0.52|||||||Chi square (2 proportion test)|||||||0.52
91500889|NCT02057198|182871819|SUPERIORITY||Slope|-0.43||||0.05|TWO_SIDED|95.0|-0.67|-0.19|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.19|-0.67|0.05
91744289|NCT00904670|183383827|SUPERIORITY_OR_OTHER||LS mean difference|20.69|STANDARD_ERROR_OF_MEAN|6.18||0.0019|TWO_SIDED|95.0|8.17|33.22|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||33.22|8.17|0.0019
91744290|NCT00904670|183383829|SUPERIORITY_OR_OTHER||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.52||0.0014|TWO_SIDED|95.0|-2.85|-0.74|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.74|-2.85|0.0014
91744291|NCT00904670|183383829|SUPERIORITY_OR_OTHER||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.76|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.76|<0.0001
91744292|NCT00904670|183383829|SUPERIORITY_OR_OTHER||LS mean difference|-3.89|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.12|-2.67|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.67|-5.12|<0.0001
91744293|NCT00904670|183383829|SUPERIORITY_OR_OTHER||LS mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.65||0.0002|TWO_SIDED|95.0|-3.97|-1.33|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.33|-3.97|0.0002
91744294|NCT00904670|183383829|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.45||0.3492|TWO_SIDED|95.0|-1.34|0.49|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.49|-1.34|0.3492
91744295|NCT00904670|183383829|SUPERIORITY_OR_OTHER||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.5||0.0105|TWO_SIDED|95.0|-2.34|-0.33|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.33|-2.34|0.0105
91744296|NCT00904670|183383830|SUPERIORITY_OR_OTHER||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.0|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.00|-2.43|<0.0001
91744297|NCT00904670|183383830|SUPERIORITY_OR_OTHER||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.78|-2.1|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.10|-3.78|<0.0001
91744298|NCT00904670|183383830|SUPERIORITY_OR_OTHER||LS mean difference|-3.34|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.11|-2.57|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.57|-4.11|<0.0001
91744299|NCT00904670|183383830|SUPERIORITY_OR_OTHER||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.64|-1.76|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.76|-3.64|<0.0001
91744300|NCT00904670|183383830|SUPERIORITY_OR_OTHER||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.41||0.0006|TWO_SIDED|95.0|-2.4|-0.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.73|-2.40|0.0006
91531326|NCT02404493|182939255|SUPERIORITY_OR_OTHER|||||||0.692||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.692
91531327|NCT02404493|182939255|SUPERIORITY_OR_OTHER|||||||0.541||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.541
91531328|NCT02404493|182939255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.492|TWO_SIDED|95.0|-0.25|0.502||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.502|-0.250|0.492
91744301|NCT00904670|183383830|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.4||0.0087|TWO_SIDED|95.0|-1.94|-0.3|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.30|-1.94|0.0087
91744302|NCT03231917|183383857|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
91744303|NCT03587428|183383862|SUPERIORITY||Mean Difference (Final Values)|-0.3252||||0.1787|TWO_SIDED|95.0|-0.8101|0.1596|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||0.1596|-0.8101|0.1787
91744304|NCT03587428|183383862|SUPERIORITY||Mean Difference (Final Values)|-0.7037||||0.0063|TWO_SIDED|95.0|-1.1886|-0.2187|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||-0.2187|-1.1886|0.0063
91744305|NCT00182078|183383866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_DEVIATION|3.4|=|0.017|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.017
91744306|NCT00182078|183383867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.9|<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
91744307|NCT00182078|183383868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|4.4|=|0.65|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.65
91744308|NCT00361231|183383893|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kaplan-Meier|||||||<0.05
91744309|NCT00361231|183383894|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
91531329|NCT02404493|182939256|SUPERIORITY_OR_OTHER|||||||0.017||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.017
91744310|NCT01732510|183383897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82||||0.015|TWO_SIDED|95.0|-16.87|-2.77|||Constrained longitudinal data analysis|||The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.||-2.77|-16.87|0.015
91744311|NCT00313144|183383917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
91744312|NCT00313144|183383919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Paired t-test|||||||0.009
91744313|NCT00313144|183383920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Paired t-test|||||||0.005
91744314|NCT00313144|183383922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||Paired t-test|||||||0.006
91744315|NCT00313144|183383923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
91500890|NCT02057198|182871819|SUPERIORITY||Slope|-0.85||||0.002|TWO_SIDED|95.0|-1.14|-0.57|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.57|-1.14|0.002
91500891|NCT02057198|182871821|SUPERIORITY|||||||0.48|||||||Chi square (two proportion test)|||||||0.48
91500892|NCT02057198|182871821|SUPERIORITY|||||||0.66|||||||Chi square (two proportion test)|||||||0.66
91500893|NCT03878745|182871823|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> 0, we can conclude in superiority.|Overall Mean|0.21|||||TWO_SIDED|95.0|0.07|0.35||||||||0.35|0.07|
91744316|NCT00313144|183383924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||Paired t-test|||||||0.046
91744317|NCT02487654|183383943|SUPERIORITY||||||<|0.05|||||||Log Rank|||||||<0.05
91744318|NCT00744380|183383946|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91744319|NCT00744380|183383947|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||For open label midazolam||||0.25
91744320|NCT00744380|183383947|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||For all midazolam||||0.048
91500894|NCT03878745|182871824|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.6|1.6||||||||1.6|-1.6|
91500895|NCT03878745|182871825|OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.6|0.1||||||||0.1|-3.6|
91500896|NCT03878745|182871826|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Terumo PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Median Difference (Final Values)|-0.5|||<|0.001|ONE_SIDED|95.0||-0.026|||Mixed Models Analysis|||||-0.026||<0.001
91500897|NCT03878745|182871827|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||||1.2|-1.2|
91500898|NCT00065507|182871829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.18|||Regression, Linear|Linear regression model adjusted for baseline HBV DNA and LVDr status.||||-1.18|-2.30|<0.0001
91744321|NCT00744380|183383947|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||For fentanyl||||0.88
91500899|NCT00065507|182871830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.85|-0.96|||Regression, Linear|adjusted for baseline HBV DNA and LVDr Status||||-0.96|-1.85|<0.0001
91500900|NCT00065507|182871831|SUPERIORITY_OR_OTHER||Mean Percent Difference|32.7|||<|0.0001|TWO_SIDED|95.0|20.2|45.2|||Cochran-Mantel-Haenszel|||||45.2|20.2|<0.0001
91500901|NCT00065507|182871832|SUPERIORITY_OR_OTHER||Mean percent treatment difference|38.0|||<|0.0001|TWO_SIDED|95.0|24.8|50.3|||Cochran-Mantel-Haenszel|||||50.3|24.8|<0.0001
91500902|NCT00065507|182871833|SUPERIORITY_OR_OTHER||percent treatment difference|19.2||||0.0193|TWO_SIDED|95.0|3.7|34.6|||Cochran-Mantel-Haenszel|||Week 24 treatment difference||34.6|3.7|0.0193
91500903|NCT00065507|182871833|SUPERIORITY_OR_OTHER||percent treatment difference|16.4||||0.0425|TWO_SIDED|95.0|0.9|32.0|||Cochran-Mantel-Haenszel|||Week 48 treatment difference||32.0|0.9|0.0425
91500904|NCT00065507|182871839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.51|TWO_SIDED|95.0|-1.63|0.82|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 24||0.82|-1.63|0.51
91744322|NCT00744380|183383948|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||For Riker scores||||0.75
91744323|NCT00744380|183383948|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||For pain scores||||0.17
91744324|NCT00744380|183383949|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For hypotension||||>0.1
91744325|NCT00744380|183383949|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For bradycardia||||>0.1
91744326|NCT00744380|183383949|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Fisher Exact|||For tachycardia||||>0.1
91744327|NCT00744380|183383949|SUPERIORITY_OR_OTHER|||||||0.07|||||||Fisher Exact|||For delirium, new onset||||0.07
91744328|NCT00744380|183383950|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Median number of experiences remembered||||0.015
91744329|NCT00744380|183383951|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91744330|NCT00744380|183383952|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
91500905|NCT00065507|182871839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|95.0|-1.08|1.88|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 48||1.88|-1.08|<0.0001
91500906|NCT00065507|182871847|SUPERIORITY_OR_OTHER||Difference Estimate|10.4|||||TWO_SIDED|95.0|-4.5|25.2||||||Difference estimate ETV - ADV at Week 48||25.2|-4.5|
91744331|NCT00744380|183383953|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For anxiety||||>0.1
91744332|NCT00744380|183383953|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For depression||||>0.1
91744333|NCT02443116|183383954|SUPERIORITY||Difference in least squares means|-8.84|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|96.0|-12.09|-5.59||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-5.59|-12.09|<0.001
91744334|NCT02443116|183383954|SUPERIORITY||Difference in least squares means|-11.06|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|96.0|-14.39|-7.74||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-7.74|-14.39|<0.001
91744335|NCT02443116|183383954|SUPERIORITY||Difference in least squares means|-2.22|STANDARD_ERROR_OF_MEAN|1.38||0.112|TWO_SIDED|96.0|-5.11|0.67|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||0.67|-5.11|0.112
91744336|NCT02443116|183383955|SUPERIORITY||Difference in least squares means|-5.73|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-8.48|-2.99|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-2.99|-8.48|<0.0001
91744337|NCT02443116|183383955|SUPERIORITY||Difference in least squares means|-6.6|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-9.41|-3.79|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.79|-9.41|<0.0001
91531330|NCT02404493|182939256|SUPERIORITY_OR_OTHER|||||||0.223||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.223
91744338|NCT02443116|183383955|SUPERIORITY||Difference in least squares means|-0.87|STANDARD_ERROR_OF_MEAN|1.43||0.5467|TWO_SIDED|95.0|-3.71|1.98|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||1.98|-3.71|0.5467
91744339|NCT02443116|183383955|SUPERIORITY||Difference in least squares means|-5.9|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.55|-3.25|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.25|-8.55|<0.0001
91744340|NCT02443116|183383955|SUPERIORITY||Difference in least squares means|-0.17|STANDARD_ERROR_OF_MEAN|1.37||0.9037|TWO_SIDED|95.0|-2.89|2.55|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||2.55|-2.89|0.9037
91500907|NCT00065507|182871848|SUPERIORITY_OR_OTHER||Difference Estimate|-0.4|||||TWO_SIDED|95.0|-8.7|8.0||||||Difference Estimate at Week 48||8.0|-8.7|
91500908|NCT00065507|182871849|SUPERIORITY_OR_OTHER||Difference Estimate|-7.2|||||TWO_SIDED|95.0|-21.3|6.9||||||Difference Estimate at Week 48||6.9|-21.3|
91744341|NCT02443116|183383955|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|1.38||0.6134|TWO_SIDED|95.0|-2.05|3.45|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||3.45|-2.05|0.6134
91744342|NCT02443116|183383956|SUPERIORITY||Difference in least squares means|-4.97|STANDARD_ERROR_OF_MEAN|1.53||0.0018|TWO_SIDED|95.0|-8.03|-1.91|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-1.91|-8.03|0.0018
91744343|NCT01932372|183383963|OTHER||Incidence rate ratio (unadjusted)|4.85|||||TWO_SIDED|95.0|3.34|7.03||||||||7.03|3.34|
91744344|NCT01932372|183383963|OTHER||Hazard ratio (unadjusted)|4.8|||||TWO_SIDED|95.0|3.31|6.96||||||||6.96|3.31|
91744345|NCT01932372|183383963|OTHER||Hazard ratio (adjusted 1)|2.07|||||TWO_SIDED|95.0|0.95|4.51||||||||4.51|0.95|
91744346|NCT01932372|183383963|OTHER||Hazard ratio (adjusted 2)|3.81|||||TWO_SIDED|95.0|2.24|6.47||||||||6.47|2.24|
91744347|NCT01932372|183383963|OTHER||Hazard ratio (adjusted 3)|3.55|||||TWO_SIDED|95.0|2.08|6.09||||||||6.09|2.08|
91744348|NCT01932372|183383963|OTHER||Hazard ratio (adjusted 4)|3.8|||||TWO_SIDED|95.0|2.31|6.25||||||||6.25|2.31|
91744349|NCT01932372|183383964|OTHER||Incidence rate ratio (unadjusted)|1.6|||||TWO_SIDED|95.0|1.16|2.19||||||||2.19|1.16|
91744350|NCT01932372|183383964|OTHER||Hazard ratio (unadjusted)|1.55|||||TWO_SIDED|95.0|1.12|2.13||||||||2.13|1.12|
91744351|NCT01932372|183383964|OTHER||Hazard ratio (adjusted 1)|1.86|||||TWO_SIDED|95.0|1.16|2.99||||||||2.99|1.16|
91744352|NCT01932372|183383964|OTHER||Hazard ratio (adjusted 2)|1.61|||||TWO_SIDED|95.0|1.06|2.43||||||||2.43|1.06|
91744353|NCT01932372|183383964|OTHER||Hazard ratio (adjusted 3)|1.53|||||TWO_SIDED|95.0|1.0|2.35||||||||2.35|1.00|
91744354|NCT01932372|183383964|OTHER||Hazard ratio (adjusted 4)|1.51|||||TWO_SIDED|95.0|1.03|2.22||||||||2.22|1.03|
91744355|NCT01932372|183383965|OTHER||Mortality rate ratio (unadjusted)|3.39|||||TWO_SIDED|95.0|1.99|5.78||||||||5.78|1.99|
91744356|NCT01932372|183383965|OTHER||Hazard ratio (unadjusted)|3.29|||||TWO_SIDED|95.0|1.93|5.61||||||||5.61|1.93|
91500909|NCT00065507|182871850|SUPERIORITY_OR_OTHER||Difference Estimate|5.7|||||TWO_SIDED|95.0|-0.3|11.7||||||Difference Estimate at Week 48||11.7|-0.3|
91744357|NCT05352412|183383968|OTHER|Mann-Whitney U|Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
91744358|NCT05352412|183383968|OTHER|Mann-Whitney U|Mann-Whitney U|0.39||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey compared with immediate follow-up survey||||0.39
91744359|NCT05352412|183383968|OTHER|Mann-Whitney U|Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.21
91744360|NCT05352412|183383968|OTHER||Mann-Whitney U|0.19||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.19
91744361|NCT05352412|183383968|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey versus immediate follow-up||||0.38
91744362|NCT05352412|183383968|OTHER||Mann-Whitney U|0.25||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.25
91744363|NCT05352412|183383968|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.07
91744364|NCT05352412|183383968|OTHER||Mann-Whitney U|0.03||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up between the two arms||||0.03
91744365|NCT05352412|183383968|OTHER||Mann-Whitney U|0.65||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge comparison between the 2 arms||||0.65
91744366|NCT05352412|183383968|OTHER||Mann-Whitney U|0.97||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-days post discharge compared between the 2 arms||||0.97
91744367|NCT05352412|183383969|OTHER||Mann-Whitney U|0.77||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline comparison between the 2 arms||||0.77
91744368|NCT05352412|183383969|OTHER||Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.85
91744369|NCT05352412|183383969|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2-week post-discharge compared with baseline survey||||0.38
91744370|NCT05352412|183383969|OTHER||Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post discharge compared with baseline survey||||0.21
91744371|NCT05352412|183383969|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.32
91744372|NCT05352412|183383969|OTHER||Mann-Whitney U|0.09||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 week post-discharge compared with baseline survey||||0.09
91744373|NCT05352412|183383969|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared with baseline survey||||0.07
91744374|NCT05352412|183383969|OTHER||Mann-Whitney U|0.26||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared between the 2 arms||||0.26
91744375|NCT05352412|183383969|OTHER||Mann-Whitney U|0.69||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared between the 2 arms||||0.69
91744376|NCT05352412|183383969|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared between the 2 arms||||0.32
91744377|NCT05352412|183383973|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
91744378|NCT05352412|183383973|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
91744379|NCT05352412|183383973|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.12
91744380|NCT05352412|183383973|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.12
91744381|NCT05352412|183383974|OTHER|Mann-Whitney U|Mann-Whitney U|0.48||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.48
91744382|NCT05352412|183383974|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
91744383|NCT05352412|183383974|OTHER|Mann-Whitney U|Mann-Whitney U|0.17||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
91744384|NCT05352412|183383974|OTHER|Mann-Whitney U|Mann-Whitney U|0.42||||0.42|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.42
91744385|NCT05352412|183383975|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||1.00
91744386|NCT05352412|183383975|OTHER|Mann-Whitney U|Mann-Whitney U|0.11||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.11
91744387|NCT05352412|183383975|OTHER|Mann-Whitney U|Mann-Whitney U|0.89||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.89
91744388|NCT05352412|183383975|OTHER|Mann-Whitney U|Mann-Whitney U|0.55||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.55
91744389|NCT05352412|183383976|OTHER|Mann-Whitney U|Mann-Whitney U|0.66||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.66
91744390|NCT05352412|183383976|OTHER|Mann-Whitney U|Mann-Whitney U|0.2||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.20
91744391|NCT05352412|183383976|OTHER|Mann-Whitney U|Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.85
91744392|NCT05352412|183383976|OTHER|Mann-Whitney U|Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up post randomization||||0.07
91744393|NCT03594747|183383977|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0001|TWO_SIDED|95.0|0.37|0.74|||One-sided stratified log-rank test|||||0.74|0.37|0.0001
91744394|NCT03594747|183383977|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67|||One-sided stratified log-rank test|||||0.67|0.33|<0.0001
91744395|NCT03594747|183383978|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.32|0.61||||||||0.61|0.32|
91744396|NCT03594747|183383978|SUPERIORITY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.3|0.59||||||||0.59|0.30|
91744397|NCT04382586|183383989|SUPERIORITY||Odds Ratio (OR)|1.61||||0.4099|TWO_SIDED|95.0|0.349|7.391|||Unstratified 1-sided Fisher's exact test|||||7.391|0.349|0.4099
91744398|NCT04382586|183383990|SUPERIORITY||Hazard Ratio (HR)|0.918||||0.7619|TWO_SIDED|95.0|0.511|1.648|||Log Rank|||||1.648|0.511|0.7619
91744399|NCT00349349|183384027|SUPERIORITY_OR_OTHER||percentage of responders|0.49|||<|0.0001|TWO_SIDED|95.3|0.39|0.6||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.60|0.39|<0.0001
91744400|NCT00349349|183384027|SUPERIORITY_OR_OTHER||percentage of responders|0.43|||<|0.0001|TWO_SIDED|95.3|0.33|0.53||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.53|0.33|<0.0001
91744401|NCT00349349|183384027|SUPERIORITY_OR_OTHER||percentage of responders|0.63|||<|0.001|TWO_SIDED|95.3|0.35|0.85||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.85|0.35|<0.001
91744402|NCT02907216|183384050|NON_INFERIORITY|Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.||2.74|-2.66|
91744403|NCT02907216|183384050|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-T antibodies should be ≥ -10%.|Difference-Seroprotective concentration|-0.69|||||TWO_SIDED|95.0|-4.39|2.71|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-T antibody concentration ≥ 0.1 IU/mL.||2.71|-4.39|
91744404|NCT02907216|183384051|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-PT antibodies should be ≥ -10%.|Difference-Seroprotective concentration|2.99|||||TWO_SIDED|95.0|-2.7|9.12|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-PT antibody concentration ≥ 10 IU/mL.||9.12|-2.7|
91744405|NCT02907216|183384051|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-FHA antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.72|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-FHA antibody concentration ≥ 10 IU/mL.||2.72|-2.66|
91760163|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-3.23|1.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-3.23|
91500910|NCT00065507|182871851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2|TWO_SIDED|95.0|0.46|1.18|||Regression, Cox|Cox proportional hazard model, adjusted for age \<=45 versus age \>45 years, gender, and race (white versus non-white).||treatment comparison of HCC-free survival at Week 48||1.18|0.46|0.20
91500911|NCT00665353|182871873|SUPERIORITY_OR_OTHER||proportion|0.158||||0.29|ONE_SIDED|90.0|0.059|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.10. The hypothesized response rate was 0.30.|||0.059|0.29
91744406|NCT02907216|183384052|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 1 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.68|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 1 seroprotective titres ≥ 8 ED50.||2.74|-2.68|
91744407|NCT02907216|183384052|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 2 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.92|2.95|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 2 seroprotective titres ≥ 8 ED50.||2.95|-2.92|
91744408|NCT02907216|183384052|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 3 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.81|||||TWO_SIDED|95.0|-2.04|4.47|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 3 seroprotective titres ≥ 8 ED50.||4.47|-2.04|
91744409|NCT03479541|183384108|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.097||||0.013|TWO_SIDED|95.0|-0.173|-0.02||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.020|-0.173|0.013
91744410|NCT03479541|183384109|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.073||||0.013|TWO_SIDED|95.0|-0.13|-0.016||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.016|-0.130|0.013
91744411|NCT03479541|183384110|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.098||||0.01|TWO_SIDED|95.0|0.024|0.173||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.173|0.024|0.010
91744412|NCT03479541|183384111|OTHER|||||||0.5158|||||||Wilcoxon (Mann-Whitney)|||||||0.5158
91744413|NCT03479541|183384112|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0404||||0.45|TWO_SIDED|95.0|-0.0648|0.146||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.146|-0.0648|0.450
91744414|NCT03479541|183384113|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the reference. Values were log-transformed for model assumptions.|Slope|0.05353||||0.6039|TWO_SIDED|95.0|-0.1503|0.2574||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Horizontal DVA Lines Lost||0.2574|-0.1503|0.6039
91760164|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-7.26|-1.5||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.50|-7.26|
91760165|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-4.65|1.12||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.12|-4.65|
91500912|NCT00665353|182871876|SUPERIORITY_OR_OTHER||proportion|0.053||||0.42|ONE_SIDED|90.0|0.001|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.02. The hypothesized response rate was 0.15.|||0.001|0.42
91500913|NCT00870363|182871881|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
91744415|NCT03479541|183384113|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the references. Values were log-transformed for model assumptions.|Slope|-0.235||||0.0414|TWO_SIDED|95.0|-0.461|-0.0093||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Vertical DVA Lines Lost||-0.0093|-0.461|0.0414
91744416|NCT03479541|183384114|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.028||||0.387|TWO_SIDED|95.0|-0.09|0.035||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.035|-0.090|0.387
91744417|NCT03479541|183384115|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.008||||0.135|TWO_SIDED|95.0|-0.003|0.019||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.019|-0.003|0.135
91744418|NCT03479541|183384116|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0107||||0.406|TWO_SIDED|95.0|-0.036|0.0146||a priori threshold p \< 0.05|Mixed Models Analysis||||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.0146|-0.0360|0.406
91744419|NCT03479541|183384117|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00391||||0.083|TWO_SIDED|95.0|-0.00052|0.00835||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.00835|-0.00052|0.083
91744420|NCT03479541|183384118|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.24|TWO_SIDED|95.0|-0.007|0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFi condition||0.002|-0.007|0.240
91744421|NCT03479541|183384118|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.005||||0.003|TWO_SIDED|95.0|-0.009|-0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFo condition||-0.002|-0.009|0.003
91744422|NCT03479541|183384119|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0112||||0.042|TWO_SIDED|95.0|-0.0219|-0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Average Lap Time||-0.0004|-0.0219|0.042
91744423|NCT03479541|183384119|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0111||||0.0311|TWO_SIDED|95.0|-0.0211|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Average Lap Time||-0.0010|-0.0211|0.0311
91500914|NCT02632552|182871888|EQUIVALENCE|Using a pre-intervention rate of 18 for both intervention and control, and a post-control change of 1, assuming an alpha of 0.05, we have power (0.8) to detect a difference of differences in change in mean urgent care/ED utilization of 0.75 with a standard deviation equal to the control mean; however, the equivalence boundary did not apply because this is a pragmatic trial.|Incidence Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.15||0.45|TWO_SIDED|95.0|0.85|1.45|||Mixed Effects Negative Binomial Model|A segmented negative binomial regression model was used to estimate changes in ED/urgent care utilization between the intervention and control groups.||||1.45|0.85|0.45
91531331|NCT02404493|182939256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.231||0.518|TWO_SIDED|95.0|-0.635|0.331||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.331|-0.635|0.518
91500915|NCT02632552|182871889|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-1.8||||0.05|TWO_SIDED|95.0|-7.21|3.61|||Mixed Models Analysis|||||3.61|-7.21|0.05
91531332|NCT02404493|182939257|SUPERIORITY_OR_OTHER|||||||0.005||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.005
91744424|NCT03479541|183384120|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00029||||0.3226|TWO_SIDED|95.0|-0.0003|0.00087||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Gait Speed||0.00087|-0.0003|0.3226
91744425|NCT03479541|183384120|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00035||||0.2218|TWO_SIDED|95.0|-0.0002|0.0009||a priori threshold p \< 0.05|Mixed Models Analysis|||Analysis for Auditory Stroop Gait Speed|The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.00090|-0.0002|0.2218
91744426|NCT03479541|183384121|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.161||||0.0742|TWO_SIDED|95.0|-0.0159|0.338||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task 180 Degree Turn Velocity||0.338|-0.0159|0.0742
91744427|NCT03479541|183384121|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.217||||0.0121|TWO_SIDED|95.0|0.048|0.385||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop 180 Degree Turn Velocity||0.385|0.0480|0.0121
91744428|NCT03479541|183384122|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00063||||0.8906|TWO_SIDED|95.0|-0.0084|0.00961||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Percentage of Double Support Time of Gait Cycle||0.00961|-0.0084|0.8906
91744429|NCT03479541|183384122|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.8447|TWO_SIDED|95.0|-0.0107|0.00874||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Percentage of Double Support Time of Gait Cycle||0.00874|-0.0107|0.8447
91744430|NCT03479541|183384123|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0003||||0.013|TWO_SIDED|95.0|-0.0005|-0.0001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Visual Weight (VS/EO)||-0.0001|-0.0005|0.013
91744431|NCT03479541|183384123|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.78|TWO_SIDED|95.0|-0.0003|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Vestibular Weight (SS+VS/EO)||0.0004|-0.0003|0.780
91760166|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-2.84|2.91||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.91|-2.84|
91500916|NCT02632552|182871890|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.38||0.03|TWO_SIDED|95.0|0.08|1.57|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.57|0.08|0.03
91744432|NCT03479541|183384124|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.235|||<|0.001|TWO_SIDED|95.0|-0.361|-0.11||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (VS/EO)||-0.110|-0.361|<0.001
91744433|NCT03479541|183384124|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.142||||0.002|TWO_SIDED|95.0|-0.233|-0.052||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (SS+VS/EO)||-0.052|-0.233|0.002
91744434|NCT03479541|183384125|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0003||||0.237|TWO_SIDED|95.0|-0.0002|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (VS/EO)||0.0007|-0.0002|0.237
91744435|NCT03479541|183384125|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0008||||0.002|TWO_SIDED|95.0|0.0003|0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (SS+VS/EO)||0.001|0.0003|0.002
91744436|NCT03479541|183384126|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.247|TWO_SIDED|95.0|-0.0001|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (VS/EO)||0.0004|-0.0001|0.247
91744437|NCT03479541|183384126|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0004||||0.008|TWO_SIDED|95.0|0.0001|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (SS+VSEO)||0.0007|0.0001|0.008
91744438|NCT03479541|183384127|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.003|TWO_SIDED|95.0|-0.006|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked Center of Mass (CoM) Sway (VS/EO)||-0.001|-0.006|0.003
91744439|NCT03479541|183384127|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.004|TWO_SIDED|95.0|-0.003|-0.0005||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked CoM Sway (SS+VS/EO)||-0.0005|-0.003|0.004
91744440|NCT03479541|183384128|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.031|TWO_SIDED|95.0|-0.007|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (VS/EO)||-0.0003|-0.007|0.031
91744441|NCT03479541|183384128|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.003|TWO_SIDED|95.0|-0.005|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (SS+VS/EO)||-0.0003|-0.005|0.003
91744442|NCT03479541|183384129|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age and gender), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0321||||0.3221|TWO_SIDED|95.0|-0.0957|0.0315||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0315|-0.0957|0.3221
91744443|NCT03479541|183384130|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0136||||0.336|TWO_SIDED|95.0|-0.0413|0.0142||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0142|-0.0413|0.336
91744444|NCT03479541|183384131|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0406||||0.033|TWO_SIDED|95.0|-0.0779|-0.0032||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.0032|-0.0779|0.033
91744445|NCT02374060|183384157|SUPERIORITY||Ratio of the proportion of BL|0.79|||<|0.0001|TWO_SIDED|99.87|0.65|0.96||Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||.96|.65|<0.0001
91744446|NCT02374060|183384157|SUPERIORITY||Ratio of the proportion of BL|0.69|||<|0.0001|TWO_SIDED|99.87|0.56|0.86||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||0.86|0.56|<0.0001
91744447|NCT02374060|183384157|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.88|||||TWO_SIDED|99.87|0.71|1.08|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.08|.71|
91531333|NCT02404493|182939257|SUPERIORITY_OR_OTHER|||||||0.821||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.821
91744448|NCT02374060|183384158|SUPERIORITY||Ratio of the proportion of BL|0.95||||0.35|TWO_SIDED|99.87|0.77|1.16||Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||1.16|0.77|0.35
91744449|NCT02374060|183384158|SUPERIORITY||Ratio of the proportion of BL|0.89||||0.07|TWO_SIDED|99.87|0.72|1.1||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||1.10|0.72|0.07
91744450|NCT02374060|183384158|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.94|||||TWO_SIDED|99.87|0.77|1.16|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.16|0.77|
91744451|NCT02374060|183384159|SUPERIORITY||Difference in proportion|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.53|||mixed effects model||Intravitreal - periocular|||0.53|0.24|<0.0001
91744452|NCT02374060|183384159|SUPERIORITY||Difference in proportion|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||mixed effects model||Dexamethasone - periocular|||0.59|0.29|<0.0001
91744453|NCT02374060|183384159|SUPERIORITY||Difference in proportion|0.05||||0.45|TWO_SIDED|95.0|-0.09|0.19|||mixed effects model||Dexamethasone - intravitreal|||0.19|-0.09|0.45
91744454|NCT02374060|183384160|SUPERIORITY||Difference in proportion|0.12||||0.1|TWO_SIDED|95.0|-0.03|0.27|||mixed effects model||Intravitreal - Periocular|||0.27|-0.03|0.10
91744455|NCT02374060|183384160|SUPERIORITY||Difference in proportion|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.28|||mixed effects model||Dexamethasone - Periocular|||0.28|-0.03|0.11
91744456|NCT02374060|183384160|SUPERIORITY||Difference in proportion|0.002||||0.98|TWO_SIDED|95.0|-0.16|0.16|||mixed effects model||Dexamethasone - Intravitreal|||0.16|-0.16|0.98
91744457|NCT02374060|183384161|SUPERIORITY||Difference in proportion|0.27||||0.0005|TWO_SIDED|95.0|0.11|0.43|||mixed effects model||Intravitreal - periocular|||0.43|0.11|0.0005
91744458|NCT02374060|183384161|SUPERIORITY||Difference in proportion|0.4|||<|0.0001|TWO_SIDED|95.0|0.25|0.56|||mixed effects model||Dexamethasone - periocular|||0.56|0.25|<0.0001
91744459|NCT02374060|183384161|SUPERIORITY||Difference in proportion|0.13||||0.12|TWO_SIDED|95.0|-0.04|0.3|||mixed effects model||Dexamethasone - intravitreal|||0.30|-0.04|0.12
91744460|NCT02374060|183384162|SUPERIORITY||Difference in proportion|0.004||||0.96|TWO_SIDED|95.0|-0.16|0.17|||mixed effects model||Intravitreal - periocular|||0.17|-0.16|0.96
91744461|NCT02374060|183384162|SUPERIORITY||Difference in proportion|0.06||||0.51|TWO_SIDED|95.0|-0.11|0.23|||mixed effects model||Dexamethasone - periocular|||0.23|-0.11|0.51
91744462|NCT02374060|183384162|SUPERIORITY||Difference in proportion|0.05||||0.54|TWO_SIDED|95.0|-0.12|0.22|||mixed effects model||Dexamethasone - intravitreal|||0.22|-0.12|0.54
91744463|NCT02374060|183384163|SUPERIORITY||Difference in mean change from BL|5.32||||0.003|TWO_SIDED|95.0|1.82|8.82|||mixed effects model||Intravitreal - periocular|||8.82|1.82|0.003
91744464|NCT02374060|183384163|SUPERIORITY||Difference in mean change from BL|5.16||||0.004|TWO_SIDED|95.0|1.6|8.72|||mixed effects model||Dexamethasone - periocular|||8.72|1.60|0.004
91744465|NCT02374060|183384163|SUPERIORITY||Difference in mean change from BL|-0.16||||0.93|TWO_SIDED|95.0|-3.67|3.34|||mixed effects model||Dexamethasone - intravitreal|||3.34|-3.67|0.93
91744466|NCT02374060|183384164|SUPERIORITY||Difference in mean change from BL|5.53||||0.013|TWO_SIDED|95.0|1.14|9.92|||mixed effects model||Intravitreal - periocular|||9.92|1.14|0.013
91744467|NCT02374060|183384164|SUPERIORITY||Difference in mean change from BL|5.14||||0.019|TWO_SIDED|95.0|0.84|9.44|||mixed effects model||Dexamethasone - periocular|||9.44|0.84|0.019
91744468|NCT02374060|183384164|SUPERIORITY||Difference in mean change from BL|-0.4||||0.84|TWO_SIDED|95.0|-4.16|3.37|||mixed effects model||Dexamethasone-intravitreal|||3.37|-4.16|0.84
91744469|NCT02374060|183384168|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.1|TWO_SIDED|95.0|0.09|1.24|||Regression, Cox||Intravitreal/Periocular|||1.24|0.09|0.10
91744470|NCT02374060|183384168|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2|TWO_SIDED|95.0|0.14|1.5|||Regression, Cox||Dexamethasone/Periocular|||1.50|0.14|0.20
91744471|NCT02374060|183384168|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.62|TWO_SIDED|95.0|0.34|6.26|||Regression, Cox||Dexamethasone/Intravitreal|||6.26|0.34|0.62
91744472|NCT02374060|183384169|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.11|TWO_SIDED|95.0|0.86|4.29|||Regression, Cox||Intravitreal/Periocular|||4.29|0.86|0.11
91744473|NCT02374060|183384169|SUPERIORITY||Hazard Ratio (HR)|2.85||||0.009|TWO_SIDED|95.0|1.3|6.28|||Regression, Cox||Dexamethasone/Intravitreal|||6.28|1.30|0.009
91744474|NCT02374060|183384169|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.3|TWO_SIDED|95.0|0.72|2.81|||Regression, Cox||Dexamethasone/intravitreal|||2.81|0.72|0.30
91744475|NCT02374060|183384170|SUPERIORITY||Hazard Ratio (HR)|1.83||||0.09|TWO_SIDED|95.0|0.91|3.65|||Regression, Cox||Intravitreal/periocular|||3.65|0.91|0.09
91744476|NCT02374060|183384170|SUPERIORITY||Hazard Ratio (HR)|2.52||||0.007|TWO_SIDED|95.0|1.29|4.91|||Regression, Cox||Dexamethasone/periocular|||4.91|1.29|0.007
91744477|NCT02374060|183384170|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.43|||Regression, Cox||Dexamethasone/intravitreal|||2.43|0.72|0.37
91744478|NCT02374060|183384171|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.92|TWO_SIDED|95.0|0.28|4.01|||Regression, Cox||Intravitreal/Periocular|||4.01|0.28|0.92
91744479|NCT02374060|183384171|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.65|TWO_SIDED|95.0|0.16|3.11|||Regression, Cox||Dexamethasone/Periocular|||3.11|0.16|0.65
91744480|NCT02374060|183384171|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.53|TWO_SIDED|95.0|0.16|2.59|||Regression, Cox||Dexamthasone/Intravitreal|||2.59|0.16|0.53
91744481|NCT05425732|183384189|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.9|||||TWO_SIDED|96.0|-2.8|1.1|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||1.1|-2.8|
91744482|NCT05425732|183384189|OTHER|Miettinen \& Nurminen method|Difference in Percent|-12.2|||||TWO_SIDED|95.0|-16.2|-8.2|||||V116 minus PCV20|Injection site pain: estimated difference in percent||-8.2|-16.2|
91744483|NCT05425732|183384189|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.3|||||TWO_SIDED|95.0|-4.4|-0.2|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||-0.2|-4.4|
91744484|NCT05425732|183384189|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.6|10.3|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||10.3|-6.6|
91500917|NCT02632552|182871891|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.75|TWO_SIDED|95.0|-0.41|0.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.29|-0.41|0.75
91500918|NCT02632552|182871892|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.70|-0.50|0.74
91531334|NCT02404493|182939257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.351||0.06|TWO_SIDED|95.0|-1.435|0.032||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.032|-1.435|0.060
91744485|NCT05425732|183384189|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.5|||||TWO_SIDED|95.0|-12.7|8.6|||||V116 minus PCV20|Injection site pain: estimated difference in percent||8.6|-12.7|
91744486|NCT05425732|183384189|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-9.2|7.9|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||7.9|-9.2|
91744487|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.6|||||TWO_SIDED|95.0|-2.7|3.8|||||V116 minus PCV20|Fatigue: estimated difference in percent||3.8|-2.7|
91744488|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|-1.5|||||TWO_SIDED|95.0|-4.1|1.2|||||V116 minus PCV20|Headache: estimated difference in percent||1.2|-4.1|
91744489|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.8|||||TWO_SIDED|96.0|-2.8|1.2|||||V116 minus PCV20|Myalgia: estimated difference in percent||1.2|-2.8|
91744490|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||||V116 minus PCV20|Pyrexia: estimated difference in percent||1.0|-1.0|
91744491|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.3|17.6|||||V116 minus PCV20|Fatigue: estimated difference in percent||17.6|-5.3|
91744492|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|5.5|||||TWO_SIDED|5.0|-5.5|15.5|||||V116 minus PCV20|Headache: estimated difference in percent||15.5|-5.5|
91744493|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.8|10.6|||||V116 minus PCV20|Myalgia: estimated difference in percent||10.6|-6.8|
91744494|NCT05425732|183384190|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-2.2|6.2|||||V116 minus PCV20|Pyrexia: estimated difference in percent||6.2|-2.2|
91500919|NCT02632552|182871893|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.87||0.63|TWO_SIDED|95.0|-2.21|1.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.29|-2.21|0.63
91744495|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.4|1.72||1-sided|cLDA model||V116/PCV20|Serotype 3: V116/PCV20 GMT Ratio||1.72|1.40|<0.001
91744496|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.88|||cLDA model||V116/PCV20|Serotype 6A: V116/PCV20 GMT Ratio||0.88|0.68|<0.001
91744497|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.95|1.18|||cLDA model||V116/PCV20|Serotype 7F: V116/PCV20 GMT Ratio||1.18|0.95|<0.001
91744498|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.38|||<|0.001|TWO_SIDED|95.0|1.25|1.53|||cLDA model||V116/PCV20|Serotype 8: V116/PCV20 GMT Ratio||1.53|1.25|<0.001
91744499|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||cLDA model||V116/PCV20|Serotype 10A: V116/PCV20 GMT Ratio||0.93|0.75|<0.001
91744500|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.39|1.72|||cLDA model||V116/PCV20|Serotype 11A: V116/PCV20 GMT Ratio||1.72|1.39|<0.001
91744501|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.92|1.21|||cLDA model||V116/PCV20|Serotype 12F: V116/PCV20 GMT Ratio||1.21|0.92|<0.001
91744502|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.69|0.84|||cLDA model||V116/PCV20|Serotype 19A: V116/PCV20 GMT Ratio||0.84|0.69|<0.001
91744503|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.72|0.92|||cLDA model||V116/PCV20|Serotype 22F: V116/PCV20 GMT Ratio||0.92|0.72|<0.001
91744504|NCT05425732|183384192|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.01|1.32|||cLDA model||V116/PCV20|Serotype 33F: V116/PCV20 GMT Ratio||1.32|1.01|<0.001
91531335|NCT02404493|182939258|SUPERIORITY_OR_OTHER|||||||0.007||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.007
91744505|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|4.55|||<|0.001|TWO_SIDED|95.0|4.12|5.04|||cLDA model||V116/PCV20|Serotype 9N: V116/PCV20 GMT Ratio||5.04|4.12|<0.001
91744506|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|3.3|||<|0.001|TWO_SIDED|95.0|2.91|3.74|||cLDA model||V116/PCV20|Serotype 15A: V116/PCV20 GMT Ratio||3.74|2.91|<0.001
91744507|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|2.03|||<|0.001|TWO_SIDED|95.0|1.77|2.34|||cLDA model||V116/PCV20|Serotype 15C: V116/PCV20 GMT Ratio||2.34|1.77|<0.001
91744508|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|5.75|||<|0.001|TWO_SIDED|95.0|5.16|6.41|||cLDA model||V116/PCV20|Serotype 16F: V116/PCV20 GMT Ratio||6.41|5.16|<0.001
91744509|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|16.86|||<|0.001|TWO_SIDED|95.0|14.9|19.09|||cLDA model||V116/PCV20|Serotype 17F: V116/PCV20 GMT Ratio||19.09|14.90|<0.001
91744510|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|9.66|||<|0.001|TWO_SIDED|95.0|8.66|10.79|||cLDA model||V116/PCV20|Serotype 20A: V116/PCV20 GMT Ratio||10.79|8.66|<0.001
91744511|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|8.1|||<|0.001|TWO_SIDED|95.0|6.86|9.55|||cLDA model||V116/PCV20|Serotype 23A: V116/PCV20 GMT Ratio||9.55|6.86|<0.001
91744512|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|10.09|||<|0.001|TWO_SIDED|95.0|8.48|12.0|||cLDA model||V116/PCV20|Serotype 23B: V116/PCV20 GMT Ratio||12.00|8.48|<0.001
91744513|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|38.71|||<|0.001|TWO_SIDED|95.0|33.87|44.25|||cLDA model||V116/PCV20|Serotype 24F: V116/PCV20 GMT Ratio||44.25|33.87|<0.001
91744514|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|21.69|||<|0.001|TWO_SIDED|95.0|18.68|25.18|||cLDA model||V116/PCV20|Serotype 31: V116/PCV20 GMT Ratio||25.18|18.68|<0.001
91744515|NCT05425732|183384192|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.59|6.8|||cLDA model||V116/PCV20|Serotype 35B: V116/PCV20 GMT Ratio||6.80|5.59|<0.001
91744516|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|44.7|||<|0.001|TWO_SIDED|95.0|40.7|48.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 9N: V116-PCV20 Percentage Difference||48.6|40.7|<0.001
91744517|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|30.9|||<|0.001|TWO_SIDED|95.0|25.8|35.8||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15A: V116-PCV20 Percentage Difference||35.8|25.8|<0.001
91744518|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|9.2|||<|0.001|TWO_SIDED|95.0|5.6|12.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15C: V116-PCV20 Percentage Difference||12.9|5.6|<0.001
91744519|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|51.1|||<|0.001|TWO_SIDED|95.0|47.1|54.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 16F: V116-PCV20 Percentage Difference||54.9|47.1|<0.001
91744520|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|66.3|||<|0.001|TWO_SIDED|95.0|62.8|69.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 17F: V116-PCV20 Percentage Difference||69.6|62.8|<0.001
91744521|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|57.7|||<|0.001|TWO_SIDED|95.0|54.2|61.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 20A: V116-PCV20 Percentage Difference||61.1|54.2|<0.001
91744522|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|42.2|||<|0.001|TWO_SIDED|95.0|37.6|46.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23A: V116-PCV20 Percentage Difference||46.6|37.6|<0.001
91500920|NCT02632552|182871894|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta of Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|1.26||0.23|TWO_SIDED|95.0|-0.97|4.05|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||4.05|-0.97|0.23
91500921|NCT02632552|182871895|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.8||0.38|TWO_SIDED|95.0|-7.95|3.1||MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.|Mixed Models Analysis|||||3.10|-7.95|0.38
91500922|NCT02632552|182871896|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|3.2||0.38|TWO_SIDED|95.0|-9.1|3.52|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||3.52|-9.10|0.38
91500923|NCT02141997|182871995|SUPERIORITY_OR_OTHER||||||=|0.863|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.863
91531336|NCT02404493|182939258|SUPERIORITY_OR_OTHER|||||||0.051||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.051
91744523|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|35.9|||<|0.001|TWO_SIDED|95.0|32.1|39.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23B: V116-PCV20 Percentage Difference||39.6|32.1|<0.001
91744524|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|74.2|||<|0.001|TWO_SIDED|95.0|71.1|77.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype24F: V116-PCV20 Percentage Difference||77.1|71.1|<0.001
91744525|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|58.6|||<|0.001|TWO_SIDED|95.0|54.8|62.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 31: V116-PCV20 Percentage Difference||62.1|54.8|<0.001
91744526|NCT05425732|183384193|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|53.2|||<|0.001|TWO_SIDED|95.0|49.6|56.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype35B: V116-PCV20 Percentage Difference||56.6|49.6|<0.001
91744527|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.9|1.33||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratio||1.33|0.90|<0.001
91744528|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.06|||<|0.001|TWO_SIDED|95.0|1.61|2.62||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratio||2.62|1.61|<0.001
91744529|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|5.0|1.23|1.84||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratio||1.84|1.23|<0.001
91744530|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.26|1.79||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratio||1.79|1.26|<0.001
91500924|NCT02141997|182871995|SUPERIORITY_OR_OTHER||||||=|0.414|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.414
91500925|NCT02141997|182871995|SUPERIORITY_OR_OTHER||||||=|0.196|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.196
91500926|NCT00598663|182872025|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|ONE_SIDED|97.5|||||ANCOVA|ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.||||||<0.0001
91500927|NCT00732615|182872032|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|52.3|||<|0.001|TWO_SIDED|95.0|40.6|64.0||A fixed sequence test procedure was used to control the study level type I error. Order of test sequence started with the primary efficacy endpoint and proceeded to the 3 secondary efficacy endpoints, in the order defined in the protocol.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between NPSP558 and the placebo treatment groups.|The above two sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis is that the % of subjects meeting primary efficacy endpoint criteria are the same for both tmt arms. The sample size was determined based on the assumption that 40% and 10% of subjects for NPSP558 and pbo arms would meet the endpt criteria, respectively. Based on 2-tailed test, alpha of 0.05 and 2-to-1 randomization ratio, 84 (56 NPSP558, 28 pbo) subjects who completing the study would achieve 80% statistical power. Adjusted for dropouts, planned enrollment was 110 subjects.||64.0|40.6|<0.001
91500928|NCT00732615|182872033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the primary endpoint reached statistical significance.|ANCOVA|ANCOVA analysis conducted using percentage change from baseline as dependent variable, treatment as factor, and baseline calcium dose as covariate.||The null hypothesis is that there is no difference between the percentage changes from baseline for the two treatment arms.||||<0.001
91531337|NCT02404493|182939258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.188||0.926|TWO_SIDED|95.0|-0.41|0.375||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.375|-0.410|0.926
91744531|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.59|2.43||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratio||2.43|1.59|<0.001
91744532|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.92||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratio||1.92|1.26|<0.001
91744533|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
91744534|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.73|||<|0.001|TWO_SIDED|95.0|1.37|2.17||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratio||2.17|1.37|<0.001
91744535|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.55|2.37||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratio||2.37|1.55|<0.001
91744536|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.36|2.35||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratio||2.35|1.36|<0.001
91744537|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
91744538|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.02||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratio||2.02|1.26|<0.001
91744539|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|0.97|1.4||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratio||1.40|0.97|<0.001
91744540|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratio||2.18|1.39|<0.001
91744541|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.99|||<|0.001|TWO_SIDED|95.0|1.58|2.49||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratio||2.49|1.58|<0.001
91744542|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.43|2.44||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratio||2.44|1.43|<0.001
91744543|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.11|2.04||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratio||2.04|1.11|<0.001
91744544|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.1|1.67||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratio||1.67|1.10|<0.001
91744545|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.63|2.69||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratio||2.69|1.63|<0.001
91744546|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.52|2.57||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratio||2.57|1.52|<0.001
91500929|NCT00732615|182872034|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.711|||<|0.001|TWO_SIDED|95.0|2.619|52.363||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the first secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the proportions of subjects (who achieved this secondary endpoint) from the two treatment arms.||52.363|2.619|<0.001
91744547|NCT05425732|183384194|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.26|1.87||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratio||1.87|1.26|<0.001
91500930|NCT00732615|182872035|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.879||||0.747|TWO_SIDED|95.0|0.402|1.922||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the second secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that the percentages of subjects with any reported clinical symptoms for the two treatment arms are the same.||1.922|0.402|0.747
91500931|NCT01341964|182872043|SUPERIORITY||Median Difference (Final Values)|0.05||||0.66|TWO_SIDED||||||t-test, 2 sided|not normally distributed, values were log-transformed.||||||0.66
91500932|NCT01516424|182872045|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|3.69|||<|0.05|TWO_SIDED|95.0|-0.36|7.75||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is ITT analysis data.|"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||7.75|-0.36|<0.05
91500933|NCT01516424|182872045|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|2.94|||<|0.05|TWO_SIDED|95.0|-0.76|6.65||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is PPS analysis data.|"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||6.65|-0.76|<0.05
91531338|NCT02404493|182939259|SUPERIORITY_OR_OTHER|||||||0.58||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.580
91531339|NCT02404493|182939259|SUPERIORITY_OR_OTHER|||||||0.363||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.363
91531340|NCT02404493|182939259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.539|TWO_SIDED|95.0|-0.531|0.286||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.286|-0.531|0.539
91744548|NCT05425732|183384195|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."||||||0.667||||||1-sided|Clopper-Pearson method.|||Serotype 6C||||0.667
91744549|NCT05425732|183384195|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method.|||Serotype 15B||||<0.001
91744550|NCT05425732|183384196|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.05|||||TWO_SIDED|95.0|1.52|2.77|||||V116 18-49 years/V116 50-64 years|Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio||2.77|1.52|
91744551|NCT05425732|183384196|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT|2.02|||<|0.001|TWO_SIDED|95.0|1.57|2.6||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratio||2.60|1.57|<0.001
91744552|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.35|1.6|||||V116/PCV20|Serotype 3: V116/PCV20 GMC Ratio||1.60|1.35|
91744553|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.7|0.89|||||V116/PCV20|Serotype 6A: V116/PCV20 GMC Ratio||0.89|0.70|
91744554|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 7F: V116/PCV20 GMC Ratio||1.18|0.95|
91744555|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.29|1.59|||||V116/PCV20|Serotype 8: V116/PCV20 GMC Ratio||1.59|1.29|
91744556|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.92|||||V116/PCV20|Serotype 10A: V116/PCV20 GMC Ratio||0.92|0.72|
91744557|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.11|1.36|||||V116/PCV20|Serotype 11A: V116/PCV20 GMC Ratio||1.36|1.11|
91744558|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26|||||V116/PCV20|Serotype 12F: V116/PCV20 GMC Ratio||1.26|0.96|
91744559|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||V116/PCV20|Serotype 19A: V116/PCV20 GMC Ratio||0.77|0.63|
91744560|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9|||||V116/PCV20|Serotype 22F: V116/PCV20 GMC Ratio||0.90|0.72|
91744561|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 33F: V116/PCV20 GMC Ratio||1.18|0.95|
91744562|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|5.41|||||TWO_SIDED|95.0|4.82|6.06|||||V116/PCV20|Serotype 9N: V116/PCV20 GMC Ratio||6.06|4.82|
91744563|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|6.79|||||TWO_SIDED|95.0|6.03|7.64|||||V116/PCV20|Serotype 15A: V116/PCV20 GMC Ratio||7.64|6.03|
91744564|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|2.46|||||TWO_SIDED|95.0|2.17|2.79|||||V116/PCV20|Serotype 15C: V116/PCV20 GMC Ratio||2.79|2.17|
91744565|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|8.75|||||TWO_SIDED|95.0|7.95|9.64|||||V116/PCV20|Serotype 16F: V116/PCV20 GMC Ratio||9.64|7.95|
91744566|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|16.75|||||TWO_SIDED|95.0|15.25|18.41|||||V116/PCV20|Serotype 17F: V116/PCV20 GMC Ratio||18.41|15.25|
91744567|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|12.92|||||TWO_SIDED|5.0|11.81|14.13|||||V116/PCV20|Serotype 20A: V116/PCV20 GMC Ratio||14.13|11.81|
91744568|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|6.42|||||TWO_SIDED|95.0|5.69|7.24|||||V116/PCV20|Serotype 23A: V116/PCV20 GMC Ratio||7.24|5.69|
91744569|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|3.25|||||TWO_SIDED|95.0|2.91|3.64|||||V116/PCV20|Serotype 23B: V116/PCV20 GMC Ratio||3.64|2.91|
91744570|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|21.08|||||TWO_SIDED|85.0|18.97|23.43|||||V116/PCV20|Serotype 24F: V116/PCV20 GMC Ratio||23.43|18.97|
91744571|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|11.31|||||TWO_SIDED|95.0|10.36|12.34|||||V116/PCV20|Serotype 31: V116/PCV20 GMC Ratio||12.34|10.36|
91744572|NCT05425732|183384197|OTHER|cLDA model|GMC Ratio|14.13|||||TWO_SIDED|95.0|12.97|15.4|||||V116/PCV20|Serotype 35B: V116/PCV20 GMC Ratio||15.40|12.97|
91744573|NCT01696994|183384235|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.95|1.04|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.04|0.95|
91744574|NCT01696994|183384237|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.99|1.48|||Poisson regression|||||1.48|0.99|
91744575|NCT01696994|183384247|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.91|1.54||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.54|.91|
91744576|NCT04644276|183384252|SUPERIORITY||Median Difference (Final Values)|-37.0|STANDARD_DEVIATION|102.0||0.8125|TWO_SIDED|95.0|-112.6|140.7|||Wilcoxon Signed-Ranks test||Unit is percent change.|Percent change in leak 100% x (\[Mask with mask adhesive\] - \[Mask without mask adhesive\])/ \[Mask without mask adhesive\]. The comparison between the two arms is captured in the reported percentage change.||140.7|-112.6|0.8125
91744577|NCT01814878|183384260|NON_INFERIORITY_OR_EQUIVALENCE|Study drug treatment group was considered non-inferior to comparator treatment group, if lower limit of the confidence interval was larger than -2.0|Mean Difference (Final Values)|-4.68||||0.1648|TWO_SIDED|95.0|-11.29|1.93||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||Non-inferiority comparison for Tramadol Hydrochloride/Acetaminophen ER to Tramadol HCl/Acetaminophen IR was performed.||1.93|-11.29|0.1648
91744578|NCT01814878|183384261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4082|TWO_SIDED|95.0|-1.1|0.45||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||0.45|-1.10|0.4082
91744579|NCT01814878|183384261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.172|TWO_SIDED|95.0|-2.68|0.48||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||0.48|-2.68|0.1720
91744580|NCT01814878|183384261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.0589|TWO_SIDED|95.0|-6.09|0.11||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||0.11|-6.09|0.0589
91744581|NCT01814878|183384262|SUPERIORITY_OR_OTHER|||||||0.1542||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1542
91744582|NCT01814878|183384262|SUPERIORITY_OR_OTHER|||||||0.0714||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0714
91744583|NCT01814878|183384262|SUPERIORITY_OR_OTHER|||||||0.1147||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.1147
91744584|NCT01814878|183384262|SUPERIORITY_OR_OTHER|||||||0.2209||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.2209
91744585|NCT01814878|183384263|SUPERIORITY_OR_OTHER|||||||0.1498||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1498
91744586|NCT01814878|183384263|SUPERIORITY_OR_OTHER|||||||0.0485||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0485
91744587|NCT01814878|183384263|SUPERIORITY_OR_OTHER|||||||0.0404||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.0404
91744588|NCT01814878|183384263|SUPERIORITY_OR_OTHER|||||||0.121||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.1210
91744589|NCT01814878|183384264|SUPERIORITY_OR_OTHER|||||||0.4216||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.4216
91744590|NCT01814878|183384265|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.1000
91744591|NCT01814878|183384266|SUPERIORITY_OR_OTHER|||||||0.3255||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.3255
91744592|NCT01814878|183384267|SUPERIORITY_OR_OTHER|||||||0.2848||||||Day 3: P-value was calculated using student's t-test|Student's t-test|||||||0.2848
91744593|NCT01200407|183384275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-35.8||||0|TWO_SIDED|95.0|-37.2|-34.4|||t-test, 2 sided|||SBP with LOCF (Week 12)||-34.4|-37.2|0.000
91744594|NCT01200407|183384275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.4||||0|TWO_SIDED|95.0|-20.3|-18.6|||t-test, 2 sided|||DBP with LOCF (Week 12)||-18.6|-20.3|0.000
91744595|NCT01200407|183384276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-24.7||||0|TWO_SIDED|95.0|-26.1|-23.4|||t-test, 2 sided|||SBP w/o LOCF (Week 4)||-23.4|-26.1|0.000
91744596|NCT01200407|183384276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-33.0||||0|TWO_SIDED|95.0|-34.4|-31.6|||t-test, 2 sided|||SBP w/o LOCF (Week 8)||-31.6|-34.4|0.000
91744597|NCT01200407|183384276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-36.3||||0|TWO_SIDED|95.0|-37.9|-34.7|||t-test, 2 sided|||SBP w/o LOCF (Week 12)||-34.7|-37.9|0.000
91744598|NCT01200407|183384276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.2||||0|TWO_SIDED|95.0|-14.0|-12.4|||t-test, 2 sided|||DBP w/o LOCF (Week 4)||-12.4|-14.0|0.000
91500934|NCT00597766|182872050|SUPERIORITY_OR_OTHER||GroupXtime interaction|-0.17||||0.16|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16|Linear mixed model|1st order antedependence covariance structure||"Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.16
91500935|NCT00597766|182872050|SUPERIORITY_OR_OTHER||group x time interaction|-0.04||||0.77|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77|linear mixed model|first order antedependent covariance structure||"Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.77
91500936|NCT00597766|182872051|SUPERIORITY_OR_OTHER||group x time interaction|-0.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2|Linear mixed model|first order antedpendent covariance structure||This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
91500937|NCT00597766|182872051|SUPERIORITY_OR_OTHER||group x time interaction|-0.02||||0.9|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9|linear mixed model|1st order antedependence covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.9
91500938|NCT00597766|182872052|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2|linear mixed model|unstructured covariance structure||The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
91513600|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
91531341|NCT02404493|182939260|SUPERIORITY_OR_OTHER|||||||0.055||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.055
91744599|NCT01200407|183384276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-17.6||||0|TWO_SIDED|95.0|-18.4|-16.7|||t-test, 2 sided|||DBP w/o LOCF (Week 8)||-16.7|-18.4|0.000
91744600|NCT01200407|183384276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.9||||0|TWO_SIDED|95.0|-20.8|-18.9|||t-test, 2 sided|||DBP w/o LOCF (Week 12)||-18.9|-20.8|0.000
91744601|NCT00425698|183384278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: Erythopoietin significantly improves kidney graft function. Power calculation: with a difference of at least 4 mL/min in mean eGFR between groups the number of patients enrolled per group (at least 41) would allowed the detection of a significant difference between groups at a 5% level (p\<0.05)||||<0.05
91744602|NCT03831191|183384310|SUPERIORITY||Odds Ratio (OR)|0.55||||0.638|TWO_SIDED|95.0|0.04|6.81|||Regression, Logistic|||||6.81|0.04|0.638
91744603|NCT03831191|183384310|SUPERIORITY||Odds Ratio (OR)|0.69||||0.773|TWO_SIDED|95.0|0.05|8.76|||Regression, Logistic|||||8.76|0.05|0.773
91744604|NCT03831191|183384310|SUPERIORITY||Odds Ratio (OR)|0.58||||0.671|TWO_SIDED|95.0|0.05|7.26|||Regression, Logistic|||||7.26|0.05|0.671
91744605|NCT03831191|183384311|SUPERIORITY||Risk Difference (RD)|-4.0|||>|0.999|TWO_SIDED|95.0|-27.2|19.9|||Fisher Exact|||||19.9|-27.2|>0.999
91744606|NCT03831191|183384311|SUPERIORITY||Risk Difference (RD)|4.5|||>|0.999|TWO_SIDED|95.0|-20.7|30.8|||Fisher Exact|||||30.8|-20.7|>0.999
91744607|NCT03831191|183384311|SUPERIORITY||Risk Difference (RD)|-19.0||||0.107|TWO_SIDED|95.0|-40.0|0.2|||Fisher Exact|||||0.2|-40.0|0.107
91744608|NCT03831191|183384312|SUPERIORITY||Risk Difference (RD)|0.2|||>|0.999|TWO_SIDED|95.0|-18.1|19.3|||Fisher Exact|||||19.3|-18.1|>0.999
91744609|NCT03831191|183384312|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|14.1|||Fisher Exact|||||14.1|-22.7|>0.999
91744610|NCT03831191|183384312|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|11.2|||Fisher Exact|||||11.2|-22.7|>0.999
91744611|NCT03831191|183384313|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
91744612|NCT03831191|183384313|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
91744613|NCT03831191|183384313|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
91744614|NCT03831191|183384314|SUPERIORITY||Median Difference (Net)|6.55||||0.31|TWO_SIDED|95.0|-6.36|19.45|||Mixed Models Analysis|||||19.45|-6.36|0.310
91744615|NCT03831191|183384314|SUPERIORITY||Mean Difference (Net)|5.56||||0.393|TWO_SIDED|95.0|-7.5|18.63|||Mixed Models Analysis|||||18.63|-7.50|0.393
91744616|NCT03831191|183384314|SUPERIORITY||Mean Difference (Net)|3.59||||0.564|TWO_SIDED|95.0|-8.91|16.08|||Mixed Models Analysis|||||16.08|-8.91|0.564
91500939|NCT00597766|182872052|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.1||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3|linear mixed model|Unstructured covariance structure||Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
91500940|NCT00597766|182872053|SUPERIORITY_OR_OTHER||group x time interaction|0.4||||0.8|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8|linear mixed model|first order antedepentent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.8
91500941|NCT00597766|182872053|SUPERIORITY_OR_OTHER||group x time interaction|1.7||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3|linear mixed model|first order antedependent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
91500942|NCT00530764|182872065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.33|TWO_SIDED|95.0|0.72|2.6|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.||2.60|0.72|0.33
91500943|NCT00530764|182872065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.62|TWO_SIDED|95.0|0.46|1.76|||Regression, Logistic|||As for Sativex Low dose versus placebo||1.76|0.46|0.62
91500944|NCT00530764|182872065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.61|TWO_SIDED|95.0|0.62|2.28|||Regression, Logistic|||As for Sativex Low dose versus placebo||2.28|0.62|0.61
91500945|NCT00530764|182872066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.5||||0.0077|TWO_SIDED|95.0|-21.35|-3.33|||Wilcoxon rank sum tests|||Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.||-3.33|-21.35|0.0077
91744617|NCT03831191|183384315|SUPERIORITY||Mean Difference (Net)|7.61||||0.356|TWO_SIDED|95.0|-8.82|24.05|||Mixed Models Analysis|||||24.05|-8.82|0.356
91744618|NCT03831191|183384315|SUPERIORITY||Mean Difference (Net)|2.33||||0.783|TWO_SIDED|95.0|-14.64|19.3|||Mixed Models Analysis|||||19.30|-14.64|0.783
91500946|NCT00530764|182872066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.97||||0.67|TWO_SIDED|95.0|-11.04|7.14|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||7.14|-11.04|0.67
91500947|NCT00530764|182872066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.75||||0.039|TWO_SIDED|95.0|-17.14|0.0|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||0.00|-17.14|0.039
91500948|NCT00530764|182872067|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.75||||0.006|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.||-0.22|-1.28|0.006
91500949|NCT00530764|182872067|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.09||||0.75|TWO_SIDED|95.0|-0.62|0.44|||ANCOVA|||As for Sativex low dose versus placebo||0.44|-0.62|0.75
91531342|NCT02404493|182939260|SUPERIORITY_OR_OTHER|||||||0.076||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.076
91500950|NCT00530764|182872067|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.36||||0.19|TWO_SIDED|95.0|-0.89|0.18|||ANCOVA|||As for Sativex low dose versus placebo||0.18|-0.89|0.19
91531343|NCT02404493|182939260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.682|TWO_SIDED|95.0|-0.672|0.449||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.449|-0.672|0.682
91744619|NCT03831191|183384315|SUPERIORITY||Mean Difference (Net)|6.52||||0.414|TWO_SIDED|95.0|-9.4|22.43|||Mixed Models Analysis|||||22.43|-9.40|0.414
91744620|NCT01626118|183384318|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|317.612|STANDARD_ERROR_OF_MEAN|149.6694||0.034|TWO_SIDED|95.0|23.297|611.926|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||611.926|23.297|0.034
91744621|NCT01626118|183384318|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|342.132|STANDARD_ERROR_OF_MEAN|150.0397||0.023|TWO_SIDED|95.0|47.09|637.175|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||637.175|47.090|0.023
91744622|NCT01626118|183384318|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|61.972|STANDARD_ERROR_OF_MEAN|150.2717||0.68|TWO_SIDED|95.0|-233.527|357.471|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||357.471|-233.527|0.680
91744623|NCT01626118|183384318|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|503.008|STANDARD_ERROR_OF_MEAN|102.3149|<|0.001|TWO_SIDED|95.0|301.93|704.086|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||704.086|301.930|<0.001
91744624|NCT01626118|183384318|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|511.357|STANDARD_ERROR_OF_MEAN|102.5851|<|0.001|TWO_SIDED|95.0|309.749|712.965|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||712.965|309.749|<0.001
91744625|NCT01626118|183384318|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|341.232|STANDARD_ERROR_OF_MEAN|102.7761|<|0.001|TWO_SIDED|95.0|139.249|543.215|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||543.215|139.249|<0.001
91744626|NCT01626118|183384319|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||||||0.191
91744627|NCT01626118|183384319|SUPERIORITY_OR_OTHER|||||||0.108|||||||t-test, 2 sided|||||||0.108
91744628|NCT01626118|183384319|SUPERIORITY_OR_OTHER|||||||0.461|||||||t-test, 2 sided|||||||0.461
91744629|NCT01626118|183384320|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
91744630|NCT01626118|183384320|SUPERIORITY_OR_OTHER|||||||0.041|||||||t-test, 2 sided|||||||0.041
91744631|NCT01626118|183384320|SUPERIORITY_OR_OTHER|||||||0.458|||||||t-test, 2 sided|||||||0.458
91744632|NCT01626118|183384321|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
91744633|NCT01626118|183384321|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
91744634|NCT01626118|183384321|SUPERIORITY_OR_OTHER|||||||0.441|||||||t-test, 2 sided|||||||0.441
91744635|NCT01626118|183384322|SUPERIORITY_OR_OTHER|||||||0.141|||||||t-test, 2 sided|||||||0.141
91744636|NCT01626118|183384322|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
91744637|NCT01626118|183384322|SUPERIORITY_OR_OTHER|||||||0.716|||||||t-test, 2 sided|||||||0.716
91744638|NCT01626118|183384323|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.049
91744639|NCT01626118|183384323|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
91744640|NCT01626118|183384323|SUPERIORITY_OR_OTHER|||||||0.593|||||||t-test, 2 sided|||||||0.593
91744641|NCT01626118|183384324|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
91744642|NCT01626118|183384324|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||||||0.012
91744643|NCT01626118|183384324|SUPERIORITY_OR_OTHER|||||||0.447|||||||t-test, 2 sided|||||||0.447
91744644|NCT01626118|183384325|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
91744645|NCT01626118|183384325|SUPERIORITY_OR_OTHER|||||||0.017|||||||t-test, 2 sided|||||||0.017
91744646|NCT01626118|183384325|SUPERIORITY_OR_OTHER|||||||0.577|||||||t-test, 2 sided|||||||0.577
91744647|NCT00002540|183384326|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.36|0.87|
91744648|NCT00002540|183384328|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.93|1.0|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.00|0.93|
91744649|NCT00002540|183384330|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|1.07|1.17|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.17|1.07|
91744650|NCT00002540|183384340|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||Poisson regression|||||1.36|0.87|
91744651|NCT01864148|183384349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9584|TWO_SIDED|95.0|0.46|2.07|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.07|0.46|0.9584
91744652|NCT01864148|183384349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0636|TWO_SIDED|95.0|0.97|3.31|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.31|0.97|0.0636
91744653|NCT01864148|183384349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.022|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.84|1.11|0.0220
91744654|NCT01864148|183384349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1771|TWO_SIDED|95.0|0.36|1.21|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.21|0.36|0.1771
91744655|NCT01864148|183384349|SUPERIORITY_OR_OTHER|||||||0.8931|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.8931
91744656|NCT01864148|183384350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.3058|TWO_SIDED|95.0|0.28|1.49|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.49|0.28|0.3058
91744657|NCT01864148|183384350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1873|TWO_SIDED|95.0|0.81|2.89|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.89|0.81|0.1873
91744658|NCT01864148|183384350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2766|TWO_SIDED|95.0|0.76|2.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.65|0.76|0.2766
91744659|NCT01864148|183384350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6578|TWO_SIDED|95.0|0.45|1.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.65|0.45|0.6578
91744660|NCT01864148|183384350|SUPERIORITY_OR_OTHER|||||||0.5255|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.5255
91500951|NCT00530764|182872068|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.73||||0.011|TWO_SIDED|95.0|-1.3|-0.17|||ANCOVA|||The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.17|-1.30|0.011
91500952|NCT00530764|182872068|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.35||||0.14|TWO_SIDED|95.0|-0.81|0.11|||ANCOVA|||As for Sativex low dose versus placebo||0.11|-0.81|0.14
91500953|NCT00530764|182872068|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.24||||0.4|TWO_SIDED|95.0|-0.81|0.32|||ANCOVA|||As for Sativex low dose versus placebo||0.32|-0.81|0.40
91744661|NCT05319899|183384411|OTHER||Geometric Mean Ratio (%)|140.63|||||TWO_SIDED|90.0|118.94|166.26||||||Analysis was performed using analysis of variance (ANOVA).||166.26|118.94|
91500954|NCT00530764|182872069|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.88||||0.003|TWO_SIDED|95.0|-1.45|-0.31|||ANCOVA|||The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.31|-1.45|0.003
91744662|NCT05319899|183384411|OTHER||Geometric Mean Ratio (%)|77.65|||||TWO_SIDED|90.0|65.67|91.8||||||Analysis was performed using ANOVA.||91.80|65.67|
91744663|NCT05319899|183384412|OTHER||Geometric Mean Ratio (%)|128.23|||||TWO_SIDED|90.0|112.99|145.52||||||Analysis was performed using ANOVA.||145.52|112.99|
91744664|NCT05319899|183384412|OTHER||Geometric Mean Ratio (%)|95.94|||||TWO_SIDED|90.0|84.54|108.88||||||Analysis was performed using ANOVA.||108.88|84.54|
91744665|NCT03525600|183384423|SUPERIORITY||LS Mean Difference|-0.2296||||0.0615|TWO_SIDED|95.0|-0.4703|0.0111|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0111|-0.4703|0.0615
91744666|NCT03525600|183384423|SUPERIORITY||LS Mean Difference|-0.2077||||0.0854|TWO_SIDED|95.0|-0.4444|0.029|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0290|-0.4444|0.0854
91744667|NCT03525600|183384424|SUPERIORITY||LS Mean Difference|-0.7451||||0.0004|TWO_SIDED|95.0|-1.1539|-0.3362|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3362|-1.1539|0.0004
91744668|NCT03525600|183384424|SUPERIORITY||LS Mean Difference|-0.6331||||0.003|TWO_SIDED|95.0|-1.0508|-0.2153|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.2153|-1.0508|0.0030
91744669|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0547||||0.4282|TWO_SIDED|95.0|-0.1899|0.0806|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0806|-0.1899|0.4282
91744670|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0793||||0.2457|TWO_SIDED|95.0|-0.2131|0.0546|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0546|-0.2131|0.2457
91744671|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1722||||0.0292|TWO_SIDED|95.0|-0.327|-0.0174|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0174|-0.3270|0.0292
91744672|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1659||||0.0352|TWO_SIDED|95.0|-0.3202|-0.0115|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0115|-0.3202|0.0352
91500955|NCT00530764|182872069|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.08||||0.78|TWO_SIDED|95.0|-0.65|0.49|||ANCOVA|||As for Sativex low dose versus placebo||0.49|-0.65|0.78
91531344|NCT02404493|182939261|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
91744673|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.145||||0.0514|TWO_SIDED|95.0|-0.2909|0.0009|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0009|-0.2909|0.0514
91744674|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.168||||0.0265|TWO_SIDED|95.0|-0.3164|-0.0196|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0196|-0.3164|0.0265
91744675|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.3532|||<|0.0001|TWO_SIDED|95.0|-0.5245|-0.1819|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1819|-0.5245|<0.0001
91744676|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2848||||0.0002|TWO_SIDED|95.0|-0.4336|-0.1361|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1361|-0.4336|0.0002
91744677|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7251||||0.0006|TWO_SIDED|95.0|-1.1373|-0.3129|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3129|-1.1373|0.0006
91744678|NCT03525600|183384425|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.698||||0.001|TWO_SIDED|95.0|-1.1142|-0.2817|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.2817|-1.1142|0.0010
91744679|NCT02168062|183384441|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
91744680|NCT02168062|183384443|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Systolic Blood Pressure measurement comparison||||0.85
91744681|NCT02168062|183384443|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Diastolic Blood Pressure measurement comparison||||0.10
91744682|NCT02168062|183384444|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Weight measurement comparison||||0.70
91744683|NCT02168062|183384445|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Percentage body fat measurement comparison||||0.11
91744684|NCT02168062|183384446|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Waist measurement comparison||||0.32
91744685|NCT02168062|183384447|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Hemoglobin A1C measurement comparison||||0.70
91744686|NCT02168062|183384448|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Insulin resistance score comparison||||0.46
91744687|NCT02168062|183384449|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Total Cholesterol measurement comparison||||0.44
91744688|NCT02168062|183384449|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Total low density lipid measurement comparison||||0.52
91744689|NCT02168062|183384449|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Total high density lipid measurement comparison||||0.40
91744690|NCT02168062|183384449|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Total triglyceride measurement comparison||||0.53
91531345|NCT02404493|182939261|SUPERIORITY_OR_OTHER|||||||0.025||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.025
91744691|NCT02168062|183384450|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Non-vigorous physical activity comparison||||0.38
91744692|NCT02168062|183384450|OTHER|||||||0.979|||||||Wilcoxon (Mann-Whitney)|||Moderate physical activity comparison||||0.979
91744693|NCT02168062|183384450|OTHER|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||Moderate-Vigorous physical activity comparison||||0.884
91744694|NCT02168062|183384450|OTHER|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Vigorous physical activity comparison||||0.678
91744695|NCT02168062|183384450|OTHER|||||||0.464|||||||Wilcoxon (Mann-Whitney)|||Total physical activity comparison||||0.464
91744696|NCT02168062|183384451|OTHER|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Average MVPA Minutes per Day Comparison||||0.838
91744697|NCT02168062|183384452|OTHER|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the lumbar spine comparison||||0.677
91744698|NCT02168062|183384452|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the femoral neck comparison||||0.493
91744699|NCT02168062|183384452|OTHER|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||Bone Density of the total hip comparison||||0.807
91500956|NCT00530764|182872069|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.33||||0.26|TWO_SIDED|95.0|-0.9|0.24|||ANCOVA|||As for Sativex low dose versus placebo.||0.24|-0.90|0.26
91500957|NCT00840294|182872101|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
91744700|NCT02168062|183384453|OTHER|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||Serum 25-(OH) vitamin D level comparison||||0.403
91744701|NCT02168062|183384454|OTHER|||||||0.385|||||||Wilcoxon (Mann-Whitney)|||||||.385
91744702|NCT02168062|183384455|OTHER|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Attention Function Index (AFI) Score Comparison||||.148
91744703|NCT02168062|183384456|OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||Mental Composite Score Comparison||||.077
91744704|NCT02168062|183384456|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||Physical Composite Score Comparison||||0.401
91744705|NCT02168062|183384457|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
91744706|NCT02168062|183384458|OTHER|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.676
91744707|NCT02168062|183384459|OTHER|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
91744708|NCT02168062|183384460|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Total Score Comparison||||0.66
91744709|NCT02168062|183384460|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Incontinence Score Comparison||||0.844
91744710|NCT02168062|183384460|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Irriation Score Comparison||||0.175
91500958|NCT00828347|182872119|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Fisher Exact|||||||0.036
91531346|NCT02404493|182939261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.991|TWO_SIDED|95.0|-0.509|0.514||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.514|-0.509|0.991
91744711|NCT02168062|183384460|OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Bowel Function Score Comparison||||0.472
91744712|NCT02168062|183384460|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Sexual Function Score Comparison||||0.405
91744713|NCT02168062|183384460|OTHER|||||||0.749|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Hormonal Function Score Comparison||||0.749
91744714|NCT02168062|183384461|OTHER|||||||0.907|||||||Wilcoxon (Mann-Whitney)|||Fatigue Scale Score Comparison||||0.907
91744715|NCT02168062|183384461|OTHER|||||||0.792|||||||Wilcoxon (Mann-Whitney)|||Energy Scale Score Comparison||||0.792
91744716|NCT00344318|183384484|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 1 was computed.|Difference in percentage|2.17|||||TWO_SIDED|95.0|-1.51|4.88||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||4.88|-1.51|
91744717|NCT00344318|183384484|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 2 was computed|Difference in percentage|-1.48||||||95.0|-6.05|1.92||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||1.92|-6.05|
91744718|NCT00344318|183384484|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 3 was computed.|Difference in percentage|3.05|||||TWO_SIDED|95.0|-1.02|6.19||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||6.19|-1.02|
91744719|NCT00344318|183384484|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C across doses was computed.|Difference in percentage|3.13|||||TWO_SIDED|95.0|-2.65|8.01||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||8.01|-2.65|
91744720|NCT00683930|183384518|SUPERIORITY_OR_OTHER||Treatment difference in response rate|5.1||||0.6558||97.5|-17.4|27.6|||Fisher Exact|Alpha = 0.025||||27.6|-17.4|0.6558
91500959|NCT01340898|182872123|SUPERIORITY_OR_OTHER||Percentage of subjects|100.0|||||TWO_SIDED|95.0|98.9|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.9|
91500960|NCT01340898|182872123|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants.||100|98.3|
91500961|NCT01340898|182872123|SUPERIORITY_OR_OTHER||Percentage of subjects|99.4|||||TWO_SIDED|95.0|97.8|99.9|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup W-135 one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||99.9|97.8|
91500962|NCT01340898|182872123|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup Y one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.3|
91500963|NCT02028065|182872170|SUPERIORITY_OR_OTHER||Difference in incidence|5.3|||||TWO_SIDED|95.0|-0.9|10.7|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||10.7|-0.9|
91531347|NCT02404493|182939262|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91531348|NCT02404493|182939262|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91744721|NCT00893152|183384550|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91744722|NCT01208961|183384618|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|400.36|||<|0.001|TWO_SIDED|90.0|326.87|490.36|||ANOVA|ANOVA on log-trans baseline-adj PK values using sequence, period, and treatments as fixed effects and subject nested within sequence as random effect||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||490.36|326.87|<0.001
91744723|NCT01208961|183384619|SUPERIORITY_OR_OTHER||Ratio of Geometric Mans|649.66|||<|0.01|TWO_SIDED|90.0|511.75|824.75||ANOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors. LSM estimate performed on log-scale|ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||824.75|511.75|<0.01
91744724|NCT01208961|183384620|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|369.66|||<|0.001|TWO_SIDED|90.0|301.74|452.86|||ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||452.86|301.74|<0.001
91744725|NCT01262560|183384621|SUPERIORITY_OR_OTHER|||||||0.92||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%).||Null hypothesis: Manuka honey in liquid form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.92
91744726|NCT01262560|183384621|SUPERIORITY_OR_OTHER|||||||0.93||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%)||Null hypothesis: Manuka honey in lozenge form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.93
91744727|NCT01262560|183384622|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.87
91531349|NCT02404493|182939262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.334|TWO_SIDED|95.0|-0.214|0.6||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.600|-0.214|0.334
91531350|NCT02404493|182939263|SUPERIORITY_OR_OTHER|||||||0.169||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.169
91744728|NCT01262560|183384622|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.46
91744729|NCT01262560|183384622|SUPERIORITY|||||||0.0023|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0023
91744730|NCT01262560|183384622|SUPERIORITY|||||||0.0025|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0025
91744731|NCT01262560|183384622|SUPERIORITY||||||<|0.0001||||||Each explanatory variable is reported separately.|Mixed Models Analysis|||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
91744732|NCT01262560|183384623|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.70
91744733|NCT01262560|183384623|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.71
91744734|NCT01262560|183384623|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0002
91744735|NCT01262560|183384623|SUPERIORITY|||||||0.0051|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0051
91744736|NCT01262560|183384623|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
91744737|NCT01262560|183384624|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.086
91744738|NCT01262560|183384624|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.20
91760167|NCT01393639|183412000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-5.33|0.39||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.39|-5.33|
91500964|NCT02028065|182872170|SUPERIORITY_OR_OTHER||Difference in incidence|8.1|||||TWO_SIDED|95.0|1.7|14.2|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen(Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||14.2|1.7|
91500965|NCT02028065|182872171|SUPERIORITY_OR_OTHER||Difference in incidence|0.0|||||TWO_SIDED|95.0|-4.8|2.5|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||2.5|-4.8|
91500966|NCT02028065|182872171|SUPERIORITY_OR_OTHER||Difference in incidence|0.7|||||TWO_SIDED|95.0|-4.2|3.7|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||3.7|-4.2|
91744739|NCT01262560|183384624|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.44
91744740|NCT01262560|183384624|SUPERIORITY|||||||0.0066|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0066
91744741|NCT01262560|183384624|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.36
91744742|NCT01262560|183384624|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.94
91744743|NCT01262560|183384624|SUPERIORITY_OR_OTHER|||||||0.58|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.58
91744744|NCT01262560|183384624|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.28
91744745|NCT01262560|183384624|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each exploratory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||<0.0001
91744746|NCT01262560|183384624|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.28
91744747|NCT01262560|183384625|SUPERIORITY_OR_OTHER|||||||0.06||||||Significance level = 0.05|Fisher Exact|||||||0.06
91744748|NCT01262560|183384625|SUPERIORITY_OR_OTHER|||||||0.31||||||Significance level = 0.05|Fisher Exact|||||||0.31
91744749|NCT01262560|183384626|SUPERIORITY_OR_OTHER|||||||0.53||||||significance level = 0.05|t-test, 2 sided|||||||0.53
91744750|NCT01262560|183384626|SUPERIORITY_OR_OTHER|||||||0.88||||||significance level = 0.05|t-test, 2 sided|||||||0.88
91744751|NCT01262560|183384627|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
91744752|NCT01262560|183384627|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
91500967|NCT02669433|182872191|SUPERIORITY||Mean Difference (Final Values)|-2.01||||0.158|TWO_SIDED|95.0|-4.8|0.79||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.79|-4.80|0.158
91500968|NCT02669433|182872191|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.6069|TWO_SIDED|95.0|-2.08|3.55||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||3.55|-2.08|0.6069
91500969|NCT02669433|182872192|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.6531|TWO_SIDED|95.0|-2.55|1.6|||Mixed Models Analysis||Placebo - active|||1.60|-2.55|0.6531
91500970|NCT02669433|182872192|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5274|TWO_SIDED|95.0|-1.41|2.75||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||2.75|-1.41|0.5274
91744753|NCT01262560|183384630|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.39
91744754|NCT01262560|183384630|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.69
91744755|NCT02791516|183384653|SUPERIORITY||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|7.6|11.5|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||11.5|7.6|<0.001
91744756|NCT02791516|183384654|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|1.4|3.7|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.7|1.4|<0.001
91744757|NCT02791516|183384655|SUPERIORITY||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.7||0.004|TWO_SIDED|95.0|0.7|3.6|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.6|0.7|0.004
91744758|NCT03088930|183384728|OTHER||Summary statistics|0.0|||||TWO_SIDED|||||||||Three subjects enrolled. No statistical analysis completed due to low accrual.|Three subjects enrolled. No statistical analysis completed due to low accrual.|||
91744759|NCT03040011|183384785|SUPERIORITY|||||||0.39|||||||Kruskal-Wallis|||||||0.39
91744760|NCT03040011|183384786|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||||||0.25
91744761|NCT03040011|183384787|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
91744762|NCT03040011|183384788|SUPERIORITY|||||||0.45|||||||Kruskal-Wallis|||||||0.45
91744763|NCT03040011|183384789|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||0.54
91744764|NCT03040011|183384790|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.80
91744765|NCT03040011|183384791|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
91744766|NCT03040011|183384792|SUPERIORITY|||||||0.64|||||||Chi-squared|||||||0.64
91744767|NCT03040011|183384793|SUPERIORITY|||||||0.41|||||||Kruskal-Wallis|||||||0.41
91744768|NCT03040011|183384795|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
91744769|NCT03040011|183384796|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
91744770|NCT03040011|183384797|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
91744771|NCT03040011|183384798|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
91744772|NCT03040011|183384799|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
91744773|NCT03040011|183384800|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
91744774|NCT03040011|183384801|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
91744775|NCT03040011|183384802|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
91744776|NCT03040011|183384803|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.40
91500971|NCT02669433|182872193|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3953|TWO_SIDED|95.0|-0.2|0.5||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.5|-0.2|0.3953
91500972|NCT02669433|182872193|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7008|TWO_SIDED|95.0|-0.28|0.42||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.42|-0.28|0.7008
91500973|NCT00576927|182872195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.655|TWO_SIDED|95.0|0.156|8.717||p-value suspect because of sparse cell counts|Chi-squared|||||8.717|0.156|0.655
91500974|NCT01850524|182872206|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.073|TWO_SIDED|95.0|0.676|1.018|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.||||1.018|0.676|0.073
91744777|NCT03040011|183384804|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
91744778|NCT02578680|183384871|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|1e-05|TWO_SIDED|95.0|0.43|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.43|<0.00001
91744779|NCT02578680|183384872|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.38|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.38|<0.00001
91744780|NCT02578680|183384873|SUPERIORITY||Difference in Percentage vs. Control|28.5|||<|0.0001|TWO_SIDED|95.0|21.1|35.4||H0:Difference in percentages=0 vs H1:Difference in percentages\>0|Stratified Miettinen and Nurminen||Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||35.4|21.1|<0.0001
91744781|NCT02578680|183384877|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.41|0.59|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.59|0.41|<0.00001
91744782|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean difference|26.28|||<|0.001|TWO_SIDED|95.0|20.33|32.22|||ANOVA|||Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.||32.22|20.33|<0.001
91531351|NCT02404493|182939263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.317|TWO_SIDED|95.0|-0.778|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-0.778|0.317
91531352|NCT02404493|182939264|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91744783|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.37|||<|0.001|TWO_SIDED|95.0|18.44|30.29|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.29|18.44|<0.001
91744784|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.48|||<|0.001|TWO_SIDED|95.0|21.53|33.42|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||33.42|21.53|<0.001
91744785|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.85|||<|0.001|TWO_SIDED|95.0|18.93|30.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.78|18.93|<0.001
91744786|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.42||||0.501|TWO_SIDED|95.0|-2.73|5.58|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.58|-2.73|0.501
91744787|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.817|TWO_SIDED|95.0|-4.61|3.64|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.64|-4.61|0.817
91744788|NCT01559259|183384890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.62||||0.216|TWO_SIDED|95.0|-1.53|6.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|-1.53|0.216
91744789|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.69|||<|0.001|TWO_SIDED|95.0|5.52|29.19|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||29.19|5.52|<0.001
91744790|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|10.02|||<|0.001|TWO_SIDED|95.0|4.36|23.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||23.02|4.36|<0.001
91744791|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.66|||<|0.001|TWO_SIDED|95.0|5.07|26.83|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||26.83|5.07|<0.001
91744792|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.6|||<|0.001|TWO_SIDED|95.0|3.74|19.77|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||19.77|3.74|<0.001
91744793|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.48||||0.014|TWO_SIDED|95.0|1.08|2.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||2.02|1.08|0.014
91531353|NCT02404493|182939264|SUPERIORITY_OR_OTHER|||||||0.182||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.182
91744794|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.332|TWO_SIDED|95.0|0.86|1.59|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.59|0.86|0.332
91744795|NCT01559259|183384891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36||||0.056|TWO_SIDED|95.0|0.99|1.85|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.85|0.99|0.056
91744796|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.1|||<|0.001|TWO_SIDED|95.0|5.24|27.91|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||27.91|5.24|<0.001
91744797|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.88|||<|0.001|TWO_SIDED|95.0|3.86|20.44|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||20.44|3.86|<0.001
91744798|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.47|||<|0.001|TWO_SIDED|95.0|4.98|26.42|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||26.42|4.98|<0.001
91744799|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.11|||<|0.001|TWO_SIDED|95.0|3.52|18.68|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||18.68|3.52|<0.001
91744800|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.012|TWO_SIDED|95.0|1.09|2.04|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||2.04|1.09|0.012
91531354|NCT02404493|182939264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.027|TWO_SIDED|95.0|-0.931|-0.069||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.069|-0.931|0.027
91531355|NCT02404493|182939265|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91744801|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.57|TWO_SIDED|95.0|0.8|1.49|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.49|0.80|0.570
91744802|NCT01559259|183384892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.41||||0.03|TWO_SIDED|95.0|1.03|1.93|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.93|1.03|0.030
91744803|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.014|TWO_SIDED|95.0|0.08|0.71|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.71|0.08|0.014
91744804|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.038|TWO_SIDED|95.0|0.02|0.64|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.02|0.038
91744805|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.003|TWO_SIDED|95.0|0.17|0.79|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.17|0.003
91744806|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.155|TWO_SIDED|95.0|-0.09|0.54|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.09|0.155
91744807|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.135|TWO_SIDED|95.0|-0.05|0.39|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.05|0.135
91744808|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.11|0.350
91744809|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|0.03|0.024
91744810|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|0.9|1.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.77|0.90|<0.001
91744811|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.83|1.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|0.83|<0.001
91531356|NCT02404493|182939265|SUPERIORITY_OR_OTHER|||||||0.08||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.080
91744812|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35||||0.001|TWO_SIDED|95.0|0.91|1.78|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.91|0.001
91744813|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.43|1.3|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|0.43|<0.001
91744814|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.003|TWO_SIDED|95.0|0.16|0.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|0.16|0.003
91744815|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.01|TWO_SIDED|95.0|0.1|0.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.10|0.010
91744816|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.18|0.002
91744817|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.12|||<|0.001|TWO_SIDED|95.0|1.66|2.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.66|<0.001
91744818|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.96|||<|0.001|TWO_SIDED|95.0|1.5|2.42|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.42|1.50|<0.001
91760168|NCT03626545|183412003|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.633|TWO_SIDED|95.0|0.76|1.48|||Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards regression model stratified by line of therapy and histology|||1.48|0.76|0.633
91744819|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.14|||<|0.001|TWO_SIDED|95.0|1.67|2.6|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.60|1.67|<0.001
91744820|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.74|||<|0.001|TWO_SIDED|95.0|1.28|2.2|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.20|1.28|<0.001
91744821|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.022|TWO_SIDED|95.0|0.05|0.7|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.05|0.022
91744822|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.181|TWO_SIDED|95.0|-0.1|0.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.10|0.181
91744823|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.016|TWO_SIDED|95.0|0.07|0.72|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.07|0.016
91744824|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.43|||<|0.001|TWO_SIDED|95.0|1.98|2.88|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.88|1.98|<0.001
91744825|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.72|2.62|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.62|1.72|<0.001
91744826|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46|||<|0.001|TWO_SIDED|95.0|2.01|2.91|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|2.01|<0.001
91744827|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.13|||<|0.001|TWO_SIDED|95.0|1.68|2.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.68|<0.001
91744828|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.065|TWO_SIDED|95.0|-0.02|0.61|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.02|0.065
91744829|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.817|TWO_SIDED|95.0|-0.28|0.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.28|0.817
91744830|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.043|TWO_SIDED|95.0|0.01|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.01|0.043
91531357|NCT02404493|182939265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.699|TWO_SIDED|95.0|-0.824|0.574||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.574|-0.824|0.699
91531358|NCT02404493|182939266|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91744831|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.06|3.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.06|<0.001
91744832|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.87|2.82|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.82|1.87|<0.001
91744833|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63|||<|0.001|TWO_SIDED|95.0|2.15|3.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.11|2.15|<0.001
91744834|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.36|||<|0.001|TWO_SIDED|95.0|1.89|2.84|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.84|1.89|<0.001
91744835|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.312|TWO_SIDED|95.0|-0.16|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-0.16|0.312
91744836|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.35|0.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.35|0.910
91744837|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.113|TWO_SIDED|95.0|-0.06|0.6|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.06|0.113
91500975|NCT01850524|182872207|SUPERIORITY||Hazard Ratio (HR)|0.998||||0.988|TWO_SIDED|95.0|0.79|1.261|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.261|0.790|0.988
91500976|NCT01850524|182872208|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.43|3.09|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||3.09|1.43|<0.001
91500977|NCT01850524|182872209|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9195|TWO_SIDED|95.0|0.656|1.463|||Regression, Logistic|Logistic regression model with prognostic factor: age (\<75 years vs \>=75) and ISS (stage I or II vs stage III).|Odds ratio \> 1 favors Ixazomib+LenDex versus LenDex alone.|||1.463|0.656|0.9195
91531359|NCT02404493|182939266|SUPERIORITY_OR_OTHER|||||||0.058||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.058
91744838|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.48|||<|0.001|TWO_SIDED|95.0|1.98|2.97|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|1.98|<0.001
91744839|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.76|2.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.75|1.76|<0.001
91744840|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|2.02|3.01|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.02|<0.001
91744841|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.35|||<|0.001|TWO_SIDED|95.0|1.86|2.85|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.85|1.86|<0.001
91744842|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.482|TWO_SIDED|95.0|-0.22|0.47|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.22|0.482
91744843|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.573|TWO_SIDED|95.0|-0.44|0.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.24|-0.44|0.573
91744844|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.368|TWO_SIDED|95.0|-0.19|0.5|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.19|0.368
91744845|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.88|2.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|1.88|<0.001
91744846|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.66|2.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.68|1.66|<0.001
91744847|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.93|2.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.96|1.93|<0.001
91744848|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.74|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.74|1.72|<0.001
91744849|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.352|TWO_SIDED|95.0|-0.19|0.53|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.19|0.352
91500978|NCT01850524|182872210|SUPERIORITY||Odds Ratio (OR)|1.16||||0.436|TWO_SIDED|95.0|0.79|1.7|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||1.70|0.79|0.436
91500979|NCT01850524|182872211|SUPERIORITY||Hazard Ratio (HR)|1.402|||<|0.001|TWO_SIDED|95.0|1.185|1.659|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.659|1.185|<0.001
91500980|NCT01850524|182872213|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.008|TWO_SIDED|95.0|0.589|0.925|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||0.925|0.589|0.008
91500981|NCT01850524|182872214|SUPERIORITY||Hazard Ratio (HR)|0.859||||0.189|TWO_SIDED|95.0|0.684|1.078|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.078|0.684|0.189
91500982|NCT01850524|182872220|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.662|TWO_SIDED|95.0|0.678|1.845|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations||1.845|0.678|0.662
91531360|NCT02404493|182939266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.711|TWO_SIDED|95.0|-0.607|0.857||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.857|-0.607|0.711
91531361|NCT02404493|182939267|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.006
91531362|NCT02404493|182939267|SUPERIORITY_OR_OTHER|||||||0.012||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.012
91531363|NCT02404493|182939267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.194||0.932|TWO_SIDED|95.0|-0.391|0.424||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.424|-0.391|0.932
91531364|NCT02404493|182939268|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
91531365|NCT02404493|182939268|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91531366|NCT02404493|182939268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.228||0.767|TWO_SIDED|95.0|-0.41|0.547||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.547|-0.410|0.767
91744850|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.771|TWO_SIDED|95.0|-0.41|0.3|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.41|0.771
91744851|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.235|TWO_SIDED|95.0|-0.14|0.58|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|-0.14|0.235
91744852|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.32|||<|0.001|TWO_SIDED|95.0|1.79|2.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.79|<0.001
91744853|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.52|2.58|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.52|<0.001
91744854|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.37|||<|0.001|TWO_SIDED|95.0|1.83|2.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|1.83|<0.001
91744855|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.2|||<|0.001|TWO_SIDED|95.0|1.66|2.73|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.73|1.66|<0.001
91744856|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.51|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.25|0.510
91744857|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.442|TWO_SIDED|95.0|-0.52|0.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.52|0.442
91500983|NCT01850524|182872221|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.271|TWO_SIDED|95.0|0.466|1.24|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations||1.240|0.466|0.271
91500984|NCT01850524|182872223|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.26|TWO_SIDED|95.0|0.661|1.12|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Time to Pain Progression||1.120|0.661|0.260
91500985|NCT02157298|182872226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1053|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.39|-0.81|<0.0001
91531367|NCT02404493|182939269|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
91531368|NCT02404493|182939269|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
91500986|NCT02157298|182872227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|5.301|<|0.0001|TWO_SIDED|95.0|-33.2|-12.2||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-12.2|-33.2|<0.0001
91744858|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.372|TWO_SIDED|95.0|-0.2|0.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.20|0.372
91500987|NCT02157298|182872228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|-1.7|-0.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.7|-1.7|<0.0001
91500988|NCT02157298|182872229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.4017||0.0743|TWO_SIDED|95.0|-1.51|0.07||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||0.07|-1.51|0.0743
91500989|NCT02157298|182872230|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4|STANDARD_ERROR_OF_MEAN|3.769||0.3727|TWO_SIDED|95.0|-4.0|10.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsitatis, Davidian, Zhang \& Lu, with adjustment with adjustment for baseline value and DPP-4||H0: proportion(dapa) minus proportion(placebo) = 0 versus alternative HA: proportion(dapa) minus proportion(placebo) =/= 0||10.7|-4.0|0.3727
91500990|NCT04059094|182872231|OTHER||Adjusted means difference|1.5|STANDARD_ERROR_OF_MEAN|2.45||0.5468|TWO_SIDED|95.0|-3.5|6.5|||Mixed model with repeated measurements||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|Mixed Model for Repeated Measures (MMRM) with fixed effects for baseline, visit, treatment, treatment-by-visit interaction, baseline-by-visit interaction, and random effect for patient was applied. No hypothesis testing was performed, as this trial was prematurely discontinued. MMRM only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-3.5|0.5468
91531369|NCT02404493|182939269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.242||0.571|TWO_SIDED|95.0|-0.65|0.37||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.370|-0.650|0.571
91531370|NCT02102464|182939373|SUPERIORITY||Mean Difference (Final Values)|11.0|||<|0.0001|TWO_SIDED|95.0|8.0|14.0|||t-test, 2 sided|||||14.0|8.0|<0.0001
91744859|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.55|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.55|1.39|<0.001
91744860|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.25|2.4|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.40|1.25|<0.001
91744861|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.57|2.72|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|1.57|<0.001
91744862|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.3|2.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|1.30|<0.001
91500991|NCT04059094|182872232|OTHER||Adjuste means difference|2.1|STANDARD_ERROR_OF_MEAN|1.83||0.3039|TWO_SIDED|95.0|-2.4|6.5|||ANCOVA||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|ANCOVA based on analysis of covariance with fixed effects for baseline and treatment was applied. Statistical analysis was performed for 200μg BI and placebo groups only. No hypothesis testing was performed, as this trial was prematurely discontinued. ANCOVA only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-2.4|0.3039
91500992|NCT01698801|182872252|SUPERIORITY_OR_OTHER||Overall dichotomized response rate|87.5|||<|0.0001|TWO_SIDED|95.0|74.269|100.0||One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.|Binomial test for dichotomized response|||||100|74.269|<0.0001
91500993|NCT00665847|182872271|SUPERIORITY_OR_OTHER||Proportion|52.5|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|42.7|62.2|||||The standard error for a proportion was calculated as the square root of the variance divided by the number of patients. The variance for a proportion is equal to p\*(1-p), with p being the proportion.|||62.2|42.7|
91500994|NCT02642614|182872400|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.59|STANDARD_ERROR_OF_MEAN|0.51||0.154|TWO_SIDED|90.0|0.93|2.72|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 5 milligram BI 1026706 divided by Placebo."|Adjusted means were calculated by exponentiating Least Square (LS) means of corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive pharmacokinetic (PK) sub-study participation and Multiple-breath washout (MBW) sub-study participation)||2.72|0.93|0.1540
91500995|NCT02642614|182872400|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.58|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|90.0|0.94|2.65|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 25 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.65|0.94|0.1430
91500996|NCT02642614|182872400|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.44|STANDARD_ERROR_OF_MEAN|0.45||0.2398|TWO_SIDED|90.0|0.86|2.41|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 100 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.41|0.86|0.2398
91744863|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.639|TWO_SIDED|95.0|-0.31|0.5|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.31|0.639
91744864|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.803|TWO_SIDED|95.0|-0.45|0.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.45|0.803
91744865|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.184|TWO_SIDED|95.0|-0.13|0.67|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.67|-0.13|0.184
91744866|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.07|2.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|1.07|<0.001
91744867|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.58|||<|0.001|TWO_SIDED|95.0|0.99|2.17|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.17|0.99|<0.001
91744868|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.25|2.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.43|1.25|<0.001
91744869|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.1|2.28|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.28|1.10|<0.001
91744870|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.44|0.39|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.44|0.910
91744871|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.607|TWO_SIDED|95.0|-0.52|0.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.52|0.607
91744872|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.484|TWO_SIDED|95.0|-0.27|0.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.56|-0.27|0.484
91531371|NCT02102464|182939374|SUPERIORITY||Mean Difference (Final Values)|-7.7|||<|0.0001|TWO_SIDED|95.0|-10.2|-5.2|||t-test, 2 sided|||||-5.2|-10.2|<0.0001
91744873|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.64|1.86|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.64|<0.001
91744874|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.75|1.97|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|0.75|<0.001
91744875|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|0.77|1.99|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.99|0.77|<0.001
91744876|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|0.89|2.1|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.10|0.89|<0.001
91744877|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.256|TWO_SIDED|95.0|-0.67|0.18|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.18|-0.67|0.256
91744878|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.526|TWO_SIDED|95.0|-0.56|0.29|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|-0.56|0.526
91744879|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.602|TWO_SIDED|95.0|-0.54|0.31|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.54|0.602
91744880|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.34|1.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.34|0.002
91500997|NCT01729754|182872425|SUPERIORITY||Difference in percentages|59.8|||<|0.001|TWO_SIDED|95.0|52.9|65.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||65.9|52.9|<0.001
91500998|NCT01729754|182872425|SUPERIORITY||Difference in percentages|55.5|||<|0.001|TWO_SIDED|95.0|48.3|61.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||61.8|48.3|<0.001
91500999|NCT01729754|182872426|SUPERIORITY||Difference in percentages|54.7|||<|0.001|TWO_SIDED|95.0|47.9|60.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||60.8|47.9|<0.001
91531372|NCT02102464|182939375|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.5|5.4|||t-test, 2 sided|||||5.4|2.5|<0.0001
91744881|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.98||||0.001|TWO_SIDED|95.0|0.38|1.59|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.59|0.38|0.001
91744882|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.65|1.86|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.65|<0.001
91744883|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.61|1.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|0.61|<0.001
91744884|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.26||||0.224|TWO_SIDED|95.0|-0.69|0.16|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.69|0.224
91744885|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.283|TWO_SIDED|95.0|-0.65|0.19|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.65|0.283
91744886|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.86|TWO_SIDED|95.0|-0.39|0.46|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.46|-0.39|0.860
91744887|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.038|TWO_SIDED|95.0|0.03|1.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.03|0.038
91531373|NCT01778062|182939381|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91531374|NCT00950937|182939386|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
91501000|NCT01729754|182872426|SUPERIORITY||Difference in percentages|50.2|||<|0.001|TWO_SIDED|95.0|43.2|56.5||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||56.5|43.2|<0.001
91744888|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.65||||0.031|TWO_SIDED|95.0|0.06|1.24|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.06|0.031
91744889|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.43|1.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.62|0.43|<0.001
91744890|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.36|1.54|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.54|0.36|0.002
91744891|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.32||||0.129|TWO_SIDED|95.0|-0.74|0.09|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.09|-0.74|0.129
91744892|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.3||||0.154|TWO_SIDED|95.0|-0.71|0.11|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.11|-0.71|0.154
91531375|NCT00950937|182939386|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531376|NCT00950937|182939386|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91744893|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.714|TWO_SIDED|95.0|-0.34|0.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.34|0.714
91744894|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.217|TWO_SIDED|95.0|-0.22|0.96|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.96|-0.22|0.217
91744895|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.136|TWO_SIDED|95.0|-0.14|1.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.03|-0.14|0.136
91744896|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.37|0.19|0.010
91744897|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.006|TWO_SIDED|95.0|0.24|1.41|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.24|0.006
91744898|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.031|TWO_SIDED|95.0|-0.87|-0.04|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.87|0.031
91744899|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.38||||0.07|TWO_SIDED|95.0|-0.79|0.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.03|-0.79|0.070
91744900|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.822|TWO_SIDED|95.0|-0.46|0.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-0.46|0.822
91744901|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.327|TWO_SIDED|95.0|-0.28|0.83|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.28|0.327
91744902|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.34||||0.224|TWO_SIDED|95.0|-0.21|0.89|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.89|-0.21|0.224
91744903|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.025|TWO_SIDED|95.0|0.08|1.19|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|0.08|0.025
91744904|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7||||0.012|TWO_SIDED|95.0|0.15|1.25|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|0.15|0.012
91501001|NCT01729754|182872429|SUPERIORITY||Difference in percentages|19.2|||<|0.001|TWO_SIDED|95.0|11.5|26.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||26.7|11.5|<0.001
91501002|NCT01729754|182872429|SUPERIORITY||Difference in percentages|20.1|||<|0.001|TWO_SIDED|95.0|12.4|27.6||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||27.6|12.4|<0.001
91501003|NCT01729754|182872432|SUPERIORITY||Difference in percentages|24.1|||<|0.001|TWO_SIDED|95.0|16.2|31.7|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||31.7|16.2|<0.001
91501004|NCT01729754|182872432|SUPERIORITY||Difference in percentages|19.6|||<|0.001|TWO_SIDED|95.0|11.7|27.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||27.3|11.7|<0.001
91501005|NCT01729754|182872435|SUPERIORITY||Difference in percentages|35.3|||<|0.001|TWO_SIDED|95.0|29.2|41.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||41.1|29.2|<0.001
91501006|NCT01729754|182872435|SUPERIORITY||Difference in percentages|37.5|||<|0.001|TWO_SIDED|95.0|31.1|43.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||43.4|31.1|<0.001
91501007|NCT01729754|182872435|SUPERIORITY||Difference in percentages|15.2|||<|0.001|TWO_SIDED|95.0|8.3|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|8.3|<0.001
91501008|NCT01729754|182872435|SUPERIORITY||Difference in percentages|17.4|||<|0.001|TWO_SIDED|95.0|10.3|24.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||24.4|10.3|<0.001
91744905|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.43||||0.03|TWO_SIDED|95.0|-0.81|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.81|0.030
91744906|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.064|TWO_SIDED|95.0|-0.75|0.02|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.02|-0.75|0.064
91744907|NCT01559259|183384893|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.721|TWO_SIDED|95.0|-0.46|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.46|0.721
91744908|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.02|0.033
91744909|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.224|TWO_SIDED|95.0|-0.08|0.33|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.08|0.224
91744910|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.024|TWO_SIDED|95.0|0.03|0.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|0.03|0.024
91744911|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.501|TWO_SIDED|95.0|-0.13|0.27|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.27|-0.13|0.501
91744912|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.036|TWO_SIDED|95.0|0.01|0.29|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|0.01|0.036
91744913|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.08|0.435
91501009|NCT01729754|182872436|OTHER||Difference in percentages|27.1|||<|0.001|TWO_SIDED|95.0|19.1|34.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||34.7|19.1|<0.001
91531377|NCT00950937|182939387|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
91501010|NCT01729754|182872436|OTHER||Difference in percentages|24.9|||<|0.001|TWO_SIDED|95.0|17.0|32.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||32.6|17.0|<0.001
91501011|NCT01729754|182872439|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|7.8|16.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.0|7.8|<0.001
91744914|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.023|TWO_SIDED|95.0|0.02|0.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|0.02|0.023
91744915|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.52|1.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|0.52|<0.001
91744916|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.37|0.97|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|0.37|<0.001
91744917|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74|||<|0.001|TWO_SIDED|95.0|0.45|1.04|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|0.45|<0.001
91744918|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.003|TWO_SIDED|95.0|0.16|0.75|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|0.16|0.003
91744919|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37|||<|0.001|TWO_SIDED|95.0|0.16|0.58|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|0.16|<0.001
91744920|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.039|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.01|0.039
91744921|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.006|TWO_SIDED|95.0|0.08|0.5|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|0.08|0.006
91744922|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|1.01|1.65|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.65|1.01|<0.001
91744923|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.85|1.49|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|0.85|<0.001
91744924|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.03|1.67|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.03|<0.001
91744925|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.72|1.36|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.36|0.72|<0.001
91744926|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.011|TWO_SIDED|95.0|0.07|0.52|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|0.07|0.011
91744927|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.267|TWO_SIDED|95.0|-0.1|0.35|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.10|0.267
91744928|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.007|TWO_SIDED|95.0|0.09|0.53|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|0.09|0.007
91744929|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.24|1.89|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.24|<0.001
91744930|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|1.06|1.7|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|1.06|<0.001
91744931|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.25|<0.001
91744932|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.02|1.67|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.02|<0.001
91501012|NCT01729754|182872439|SUPERIORITY||Difference in percentages|12.4|||<|0.001|TWO_SIDED|95.0|8.5|16.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.6|8.5|<0.001
91501013|NCT01729754|182872439|SUPERIORITY||Difference in percentages|7.0||||0.001|TWO_SIDED|95.0|2.8|11.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||11.6|2.8|0.001
91501014|NCT01729754|182872439|SUPERIORITY||Difference in percentages|7.6|||<|0.001|TWO_SIDED|95.0|3.3|12.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.3|3.3|<0.001
91501015|NCT01729754|182872440|SUPERIORITY||Difference in percentages|15.7|||<|0.001|TWO_SIDED|95.0|9.4|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|9.4|<0.001
91744933|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.056|TWO_SIDED|95.0|-0.01|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.01|0.056
91744934|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.759|TWO_SIDED|95.0|-0.19|0.26|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.26|-0.19|0.759
91744935|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.051|TWO_SIDED|95.0|0.0|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.00|0.051
91744936|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.3|1.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.30|<0.001
91744937|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.18|1.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.18|<0.001
91531378|NCT00950937|182939387|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91744938|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.71|||<|0.001|TWO_SIDED|95.0|1.37|2.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.05|1.37|<0.001
91744939|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.19|1.86|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.19|<0.001
91744940|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.342|TWO_SIDED|95.0|-0.12|0.35|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.12|0.342
91744941|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.24|0.23|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.24|0.943
91744942|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.18||||0.126|TWO_SIDED|95.0|-0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|-0.05|0.126
91744943|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.27|1.98|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.27|<0.001
91744944|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|1.15|1.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.15|<0.001
91744945|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.29|2.0|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.00|1.29|<0.001
91744946|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.18|1.89|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.18|<0.001
91744947|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.453|TWO_SIDED|95.0|-0.15|0.34|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.15|0.453
91531379|NCT00950937|182939387|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91744948|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.816|TWO_SIDED|95.0|-0.28|0.22|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.28|0.816
91744949|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.384|TWO_SIDED|95.0|-0.14|0.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.36|-0.14|0.384
91744950|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.55|||<|0.001|TWO_SIDED|95.0|1.19|1.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.91|1.19|<0.001
91744951|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
91744952|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|1.25|<0.001
91744953|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
91744954|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.09||||0.483|TWO_SIDED|95.0|-0.16|0.34|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.16|0.483
91744955|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.25|0.25|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.25|0.991
91501016|NCT01729754|182872440|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|5.6|17.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||17.9|5.6|<0.001
91501017|NCT01729754|182872444|OTHER||Difference in least squares means|-8.2|||<|0.001|TWO_SIDED|95.0|-9.3|-7.2|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.2|-9.3|<0.001
91501018|NCT01729754|182872444|OTHER||Difference in least squares means|-8.3|||<|0.001|TWO_SIDED|95.0|-9.3|-7.3|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.3|-9.3|<0.001
91501019|NCT01729754|182872444|OTHER||Difference in least squares means|-1.3||||0.002|TWO_SIDED|95.0|-2.1|-0.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.5|-2.1|0.002
91501020|NCT01729754|182872444|OTHER||Difference in least squares means|-1.4||||0.001|TWO_SIDED|95.0|-2.2|-0.6|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.6|-2.2|0.001
91501021|NCT01729754|182872445|OTHER||Difference in least squares means|-1.7|||<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.0|-2.4|<0.001
91501022|NCT01729754|182872445|OTHER||Difference in least squares means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.9|-1.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.5|-2.9|<0.001
91531380|NCT00950937|182939388|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
91744956|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.228|TWO_SIDED|95.0|-0.1|0.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-0.10|0.228
91744957|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48|||<|0.001|TWO_SIDED|95.0|1.1|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.10|<0.001
91744958|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.69|0.94|<0.001
91744959|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.15|1.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.15|<0.001
91744960|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.4|||<|0.001|TWO_SIDED|95.0|1.03|1.78|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|1.03|<0.001
91501023|NCT01729754|182872448|OTHER||Difference in percentages|39.3|||<|0.001|TWO_SIDED|95.0|31.8|46.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||46.1|31.8|<0.001
91501024|NCT01729754|182872448|OTHER||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|24.5|39.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||39.1|24.5|<0.001
91501025|NCT01729754|182872448|OTHER||Difference in percentages|11.9||||0.003|TWO_SIDED|95.0|4.1|19.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||19.5|4.1|0.003
91744961|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.587|TWO_SIDED|95.0|-0.19|0.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.19|0.587
91744962|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09||||0.517|TWO_SIDED|95.0|-0.35|0.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.35|0.517
91744963|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.36|TWO_SIDED|95.0|-0.14|0.38|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.14|0.360
91744964|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.81|1.6|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.60|0.81|<0.001
91744965|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.78|1.57|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.57|0.78|<0.001
91744966|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.76|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.76|0.97|<0.001
91744967|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.77|1.56|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.77|<0.001
91744968|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.811|TWO_SIDED|95.0|-0.24|0.31|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.24|0.811
91744969|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.977|TWO_SIDED|95.0|-0.27|0.28|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.27|0.977
91501026|NCT01729754|182872448|OTHER||Difference in percentages|4.8||||0.221|TWO_SIDED|95.0|-2.9|12.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.5|-2.9|0.221
91744970|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.164|TWO_SIDED|95.0|-0.08|0.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.08|0.164
91744971|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.63|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.43|0.63|<0.001
91744972|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.40|0.60|<0.001
91501027|NCT01729754|182872449|OTHER||Difference in percentages|25.7|||<|0.001|TWO_SIDED|95.0|17.7|33.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||33.4|17.7|<0.001
91501028|NCT01729754|182872449|OTHER||Difference in percentages|15.0|||<|0.001|TWO_SIDED|95.0|6.9|22.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.9|6.9|<0.001
91501029|NCT01853046|182872458|SUPERIORITY_OR_OTHER||LS Mean|1.14|||||TWO_SIDED|90.0|0.796|1.63||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of regorafenib calculated by re-transformation of the logarithmic data from ANOVAs.||1.63|0.796|
91744973|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15|||<|0.001|TWO_SIDED|95.0|0.75|1.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.75|<0.001
91744974|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06|||<|0.001|TWO_SIDED|95.0|0.66|1.46|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.46|0.66|<0.001
91744975|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.846|TWO_SIDED|95.0|-0.31|0.25|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.31|0.846
91501030|NCT01853046|182872458|SUPERIORITY_OR_OTHER||LS-means|0.684|||||TWO_SIDED|90.0|0.397|1.18||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-2 calculated by re-transformation of the logarithmic data from ANOVAs.||1.18|0.397|
91501031|NCT01853046|182872458|SUPERIORITY_OR_OTHER||LS-means|0.446|||||TWO_SIDED|90.0|0.2|0.996||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-5 calculated by re-transformation of the logarithmic data from ANOVAs||0.996|0.200|
91501032|NCT05022784|182872483|OTHER||||||<|0.0001|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compares the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||<.0001
91501033|NCT05022784|182872484|OTHER||||||<|0.0001|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||<.0001
91501034|NCT05022784|182872485|OTHER|||||||0.37|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.37
91501035|NCT05022784|182872486|OTHER|||||||0.477|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.477
91531381|NCT00950937|182939388|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91744976|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.702|TWO_SIDED|95.0|-0.33|0.23|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.33|0.702
91744977|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.496|TWO_SIDED|95.0|-0.18|0.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.18|0.496
91744978|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.41|<0.001
91744979|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.4|1.21|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.40|<0.001
91501036|NCT05022784|182872487|OTHER|||||||0.644|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.644
91501037|NCT05022784|182872488|OTHER|||||||0.206|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.206
91501038|NCT05022784|182872489|OTHER|||||||0.052|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.052
91501039|NCT05022784|182872490|OTHER|||||||0.044|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.044
91501040|NCT05022784|182872491|OTHER|||||||0.525|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.525
91501041|NCT05022784|182872492|OTHER|||||||0.024|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.024
91501042|NCT05022784|182872493|OTHER|||||||0.016|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.016
91501043|NCT05022784|182872494|OTHER|||||||0.913|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.913
91531382|NCT00950937|182939388|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531383|NCT00950937|182939389|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
91744980|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.26|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.26|0.46|<0.001
91744981|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.52|1.33|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.52|<0.001
91744982|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.441|TWO_SIDED|95.0|-0.39|0.17|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.39|0.441
91501044|NCT05022784|182872495|OTHER|||||||0.448|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.448
91501045|NCT05022784|182872496|OTHER|||||||0.515|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.515
91744983|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.408|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.40|0.408
91744984|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.06||||0.652|TWO_SIDED|95.0|-0.35|0.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.35|0.652
91744985|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61||||0.003|TWO_SIDED|95.0|0.21|1.02|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|0.21|0.003
91744986|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.007|TWO_SIDED|95.0|0.15|0.95|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.15|0.007
91744987|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
91744988|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
91744989|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.08||||0.567|TWO_SIDED|95.0|-0.36|0.2|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.36|0.567
91744990|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.315|TWO_SIDED|95.0|-0.42|0.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-0.42|0.315
91501046|NCT05022784|182872497|OTHER|||||||0.829|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.829
91501047|NCT05022784|182872498|OTHER|||||||0.471|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.471
91501048|NCT05022784|182872499|OTHER|||||||0.915|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.915
91501049|NCT05022784|182872500|OTHER|||||||0.19|||||||Chi-squared|||||||0.190
91744991|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.997|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.28|0.997
91744992|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.056|TWO_SIDED|95.0|-0.01|0.77|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|-0.01|0.056
91744993|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.047|TWO_SIDED|95.0|0.01|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|0.01|0.047
91744994|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.95|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.17|0.005
91744995|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.007|TWO_SIDED|95.0|0.14|0.92|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|0.14|0.007
91501050|NCT05022784|182872501|OTHER|||||||0.928|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.928
91744996|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.276|TWO_SIDED|95.0|-0.42|0.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.12|-0.42|0.276
91744997|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.318|TWO_SIDED|95.0|-0.41|0.13|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.41|0.318
91744998|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.849|TWO_SIDED|95.0|-0.25|0.3|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.25|0.849
91744999|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.138|TWO_SIDED|95.0|-0.09|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.09|0.138
91745000|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.111|TWO_SIDED|95.0|-0.07|0.68|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.68|-0.07|0.111
91745001|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.031|TWO_SIDED|95.0|0.04|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.04|0.031
91745002|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.49||||0.011|TWO_SIDED|95.0|0.11|0.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.87|0.11|0.011
91745003|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.2||||0.135|TWO_SIDED|95.0|-0.47|0.06|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.47|0.135
91745004|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.175|TWO_SIDED|95.0|-0.44|0.08|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.08|-0.44|0.175
91745005|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.59|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.34|0.590
91745006|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.402|TWO_SIDED|95.0|-0.2|0.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.20|0.402
91745007|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.261|TWO_SIDED|95.0|-0.15|0.54|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.15|0.261
91745008|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.134|TWO_SIDED|95.0|-0.08|0.61|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.08|0.134
91501051|NCT05022784|182872502|OTHER|||||||0.49|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.490
91501052|NCT05022784|182872503|OTHER|||||||0.667|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.667
91745009|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.03|0.031
91745010|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.061|TWO_SIDED|95.0|-0.47|0.01|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-0.47|0.061
91745011|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.138|TWO_SIDED|95.0|-0.42|0.06|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.42|0.138
91745012|NCT01559259|183384894|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.353|TWO_SIDED|95.0|-0.35|0.13|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.35|0.353
91745013|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.88||||0.006|TWO_SIDED|95.0|0.25|1.51|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.51|0.25|0.006
91745014|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69||||0.03|TWO_SIDED|95.0|0.07|1.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|0.07|0.030
91745015|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81||||0.012|TWO_SIDED|95.0|0.17|1.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|0.17|0.012
91531384|NCT00950937|182939389|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531385|NCT00950937|182939389|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531386|NCT00950937|182939390|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
91531387|NCT00950937|182939390|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531388|NCT00950937|182939390|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531389|NCT00950937|182939391|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
91745016|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.237|TWO_SIDED|95.0|-0.25|1.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.01|-0.25|0.237
91501053|NCT05022784|182872504|OTHER|||||||0.032|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.032
91501054|NCT05022784|182872505|OTHER|||||||0.721|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.721
91745017|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.5||||0.024|TWO_SIDED|95.0|0.07|0.93|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|0.07|0.024
91531390|NCT00950937|182939391|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531391|NCT00950937|182939391|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
91531392|NCT00950937|182939392|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|Paired t-test was utilized to compare the two groups (HIV group and Control group)||||||<0.05
91745018|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.15|TWO_SIDED|95.0|-0.11|0.73|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.11|0.150
91745019|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.43||||0.054|TWO_SIDED|95.0|-0.01|0.86|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.01|0.054
91501055|NCT05022784|182872506|OTHER|||||||0.352|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.352
91501056|NCT05022784|182872507|OTHER|||||||0.136|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.136
91501057|NCT05022784|182872508|OTHER|||||||0.27|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.270
91531393|NCT00462644|182939409|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
91531394|NCT00462644|182939410|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
91531395|NCT00462644|182939411|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
91531396|NCT00462644|182939412|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||Normality was tested using the Kolmogorow-Smirnov test.||||0.022
91531397|NCT00462644|182939413|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91531398|NCT00462644|182939414|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91531399|NCT03317379|182939416|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.17|0.22||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.22|-0.17|.80
91531400|NCT03317379|182939416|SUPERIORITY||estimate of fixed effects|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.32|TWO_SIDED|95.0|-0.1|0.3||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.30|-0.10|.32
91531401|NCT03317379|182939417|SUPERIORITY||estimate of fixed effects|0.14|STANDARD_ERROR_OF_MEAN|0.05||0.01|TWO_SIDED|95.0|0.03|0.24||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.24|0.03|0.01
91531402|NCT03317379|182939417|SUPERIORITY||estimate of fixed effects|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.28|TWO_SIDED|95.0|-0.07|0.23||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.23|-.07|0.28
91531403|NCT03317379|182939418|SUPERIORITY||estimate of fixed effects|0.61|STANDARD_ERROR_OF_MEAN|0.28||0.03|TWO_SIDED|95.0|0.06|1.16||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||1.16|0.06|0.03
91531404|NCT03317379|182939418|SUPERIORITY||estimate of fixed effects|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|95.0|0.09|1.27|||Mixed Models Analysis|||||1.27|0.09|0.02
91745020|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.89|||<|0.001|TWO_SIDED|95.0|1.92|3.85|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.85|1.92|<0.001
91501058|NCT05022784|182872509|OTHER|||||||0.306|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.306
91531405|NCT03317379|182939419|SUPERIORITY||estimate of fixed effects|0.2|STANDARD_ERROR_OF_MEAN|0.11||0.08|TWO_SIDED|95.0|-0.02|0.42||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.42|-0.02|0.08
91745021|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.52|||<|0.001|TWO_SIDED|95.0|1.56|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.56|<0.001
91745022|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.54|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.54|<0.001
91745023|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.76|||<|0.001|TWO_SIDED|95.0|0.79|2.72|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|0.79|<0.001
91745024|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.13|||<|0.001|TWO_SIDED|95.0|0.47|1.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.79|0.47|<0.001
91745025|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.76||||0.021|TWO_SIDED|95.0|0.11|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.11|0.021
91745026|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.027|TWO_SIDED|95.0|0.09|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.09|0.027
91745027|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.75|||<|0.001|TWO_SIDED|95.0|3.65|5.84|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.84|3.65|<0.001
91745028|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.21|||<|0.001|TWO_SIDED|95.0|3.13|5.29|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.29|3.13|<0.001
91745029|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.47|||<|0.001|TWO_SIDED|95.0|3.37|5.56|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.56|3.37|<0.001
91745030|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.92|||<|0.001|TWO_SIDED|95.0|2.83|5.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.02|2.83|<0.001
91745031|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.58|0.08|0.031
91745032|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.442|TWO_SIDED|95.0|-0.44|1.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.44|0.442
91745033|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.152|TWO_SIDED|95.0|-0.2|1.3|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.20|0.152
91745034|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.62|||<|0.001|TWO_SIDED|95.0|4.52|6.72|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.72|4.52|<0.001
91745035|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.04|||<|0.001|TWO_SIDED|95.0|3.96|6.13|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.13|3.96|<0.001
91745036|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.4|||<|0.001|TWO_SIDED|95.0|4.3|6.5|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.30|<0.001
91501059|NCT05022784|182872510|OTHER|||||||0.145|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.145
91501060|NCT05022784|182872511|OTHER|||||||0.109|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.109
91531406|NCT03317379|182939419|SUPERIORITY||estimate of fixed effects|0.18|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.04|0.41||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.41|-0.04|0.12
91501061|NCT05022784|182872512|OTHER|||||||0.454|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.454
91501062|NCT05022784|182872513|OTHER|||||||0.96|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.960
91501063|NCT05022784|182872514|OTHER|||||||0.265|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.265
91501064|NCT05022784|182872515|OTHER|||||||0.026|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.026
91501065|NCT05022784|182872516|OTHER|||||||0.016|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.016
91501066|NCT05022784|182872517|OTHER|||||||0.937|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.937
91501067|NCT05022784|182872518|OTHER|||||||0.948|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.948
91531407|NCT03317379|182939420|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.22||0.18|TWO_SIDED|95.0|-0.14|0.74||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.74|-0.14|0.18
91745037|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.88|||<|0.001|TWO_SIDED|95.0|3.78|5.98|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.98|3.78|<0.001
91745038|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.055|TWO_SIDED|95.0|-0.01|1.49|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|-0.01|0.055
91745039|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.666|TWO_SIDED|95.0|-0.57|0.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.90|-0.57|0.666
91501068|NCT05022784|182872519|OTHER|||||||0.574|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.574
91501069|NCT05022784|182872520|OTHER|||||||0.491|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.491
91501070|NCT05022784|182872521|OTHER|||||||0.432|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.432
91501071|NCT00594997|182872557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||p\<0.05 threshold for statistical significance|Regression, Linear|||||||<0.0001
91501072|NCT02389998|182872561|SUPERIORITY||||||<|0.03|||||||ANCOVA|||||||<0.03
91501073|NCT02389998|182872562|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
91501074|NCT02389998|182872563|SUPERIORITY|||||||0.3|||||||McNemar|||||||0.3
91501075|NCT01770379|182872593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.2001|TWO_SIDED|95.0|0.79|3.03|||Regression, Logistic|||||3.03|0.79|0.2001
91501076|NCT01770379|182872593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1574|TWO_SIDED|95.0|0.83|3.15|||Regression, Logistic|||||3.15|0.83|0.1574
91501077|NCT00778700|182872597|SUPERIORITY||Least Squares (LS) Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.406||0.0041|TWO_SIDED|90.0|-1.85|-0.51|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.51|-1.85|0.0041
91501078|NCT00778700|182872597|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.408||0.0007|TWO_SIDED|90.0|-2.08|-0.73|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.73|-2.08|0.0007
91501079|NCT00778700|182872597|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.407||0.0035|TWO_SIDED|90.0|-1.88|-0.53|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.53|-1.88|0.0035
91501080|NCT03274440|182872618|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction effect between condition and time (includes all three groups and all time points)||||.577
91531408|NCT03317379|182939420|SUPERIORITY||estimate of fixed effects|0.16|STANDARD_ERROR_OF_MEAN|0.23||0.5|TWO_SIDED|95.0|-0.3|0.62||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.62|-0.30|0.50
91531409|NCT04445155|182939421|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
91745040|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.181|TWO_SIDED|95.0|-0.24|1.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|-0.24|0.181
91745041|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.86|||<|0.001|TWO_SIDED|95.0|4.71|7.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||7.01|4.71|<0.001
91501081|NCT03274440|182872618|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=10.50; df=6, 10||Test for main effect of time (includes all three groups and all time points)||||<.001
91501082|NCT03274440|182872618|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.72|||||||Linear mixed effects regression|||Test for main effect of condition (includes all three groups and all time points)||||.72
91501083|NCT03274440|182872619|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction between condition and time||||.577
91745042|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.43|||<|0.001|TWO_SIDED|95.0|4.29|6.57|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.57|4.29|<0.001
91745043|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.79|||<|0.001|TWO_SIDED|95.0|4.64|6.94|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.94|4.64|<0.001
91745044|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.34|||<|0.001|TWO_SIDED|95.0|4.19|6.5|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.19|<0.001
91745045|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.2|TWO_SIDED|95.0|-0.27|1.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|-0.27|0.200
91501084|NCT03274440|182872619|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=7.00, df=6,10||Test for main effect of time||||<.001
91501085|NCT03274440|182872619|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.002|||||||Linear mixed effects regression|F=6.26, df=2, 10||Test for main effect of condition||||.002
91501086|NCT02611778|182872643|EQUIVALENCE|The confidence interval (CI) for treatment difference (FYB201 - Lucentis) was calculated using Least Square Means. If the 90% CI was completely contained in the interval \]-3.5;3.5\[ ETDRS letters, equivalence of FYB201 and Lucentis could be concluded.|Difference in least square means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.6|0.9|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|The hypothesis of biosimilarity of FYB201 and Lucentis was tested with a two-sided equivalence test with an equivalence margin of 3 ETDRS letters. An ANCOVA model was used with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and the country and the treatment group as fixed effects.||0.9|-1.6|
91501087|NCT02611778|182872644|OTHER||Difference in least square means|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.6|1.5|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 24 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.5|-1.6|
91501088|NCT02611778|182872645|OTHER||Difference in least square means|-0.1|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-1.8|1.7|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 48 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.7|-1.8|
91501089|NCT02611778|182872646|OTHER||Difference in least square means|0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.6|1.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and 12 months (average of Weeks 40, 44 and 48) as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.8|-1.6|
91501090|NCT02611778|182872647|OTHER||Difference in least square means|0.69|STANDARD_ERROR_OF_MEAN|11.469|||TWO_SIDED|90.0|-18.22|19.6|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||19.60|-18.22|
91745046|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.831|TWO_SIDED|95.0|-0.69|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.69|0.831
91745047|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.268|TWO_SIDED|95.0|-0.34|1.24|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|-0.34|0.268
91745048|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.73|||<|0.001|TWO_SIDED|95.0|4.54|6.91|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.91|4.54|<0.001
91501091|NCT02611778|182872648|OTHER||Difference in least square means|2.68|STANDARD_ERROR_OF_MEAN|11.632|||TWO_SIDED|90.0|-16.49|21.85|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||21.85|-16.49|
91501092|NCT02611778|182872649|OTHER||Difference in least square means|-5.91|STANDARD_ERROR_OF_MEAN|10.136|||TWO_SIDED|90.0|-22.62|10.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||10.80|-22.62|
91501093|NCT02611778|182872650|OTHER||Difference in least square means|3.68|STANDARD_ERROR_OF_MEAN|10.285|||TWO_SIDED|90.0|-13.28|20.63|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||20.63|-13.28|
91501094|NCT02611778|182872651|OTHER||Difference in least square means|0.07|STANDARD_ERROR_OF_MEAN|0.4709|||TWO_SIDED|90.0|-0.706|0.846|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 24 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||0.846|-0.706|
91501095|NCT02611778|182872652|OTHER||Difference in least square means|0.342|STANDARD_ERROR_OF_MEAN|0.5387|||TWO_SIDED|90.0|-0.547|1.23|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 48 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.230|-0.547|
91501096|NCT02611778|182872653|OTHER||Difference in least square means|0.21|STANDARD_ERROR_OF_MEAN|0.886|||TWO_SIDED|90.0|-1.25|1.67|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 24 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.67|-1.25|
91501097|NCT02611778|182872654|OTHER||Difference in least square means|1.73|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|90.0|0.04|3.42|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 48 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||3.42|0.04|
91745049|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.31|||<|0.001|TWO_SIDED|95.0|4.13|6.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.48|4.13|<0.001
91745050|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.6|||<|0.001|TWO_SIDED|95.0|4.41|6.78|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|4.41|<0.001
91745051|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.35|||<|0.001|TWO_SIDED|95.0|4.17|6.54|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.17|<0.001
91745052|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.367|TWO_SIDED|95.0|-0.44|1.19|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|-0.44|0.367
91531410|NCT04445155|182939423|SUPERIORITY|||||||0.011|||||||Paired t-test|||"Null Hypothesis: The means of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The means of the scores are different at baseline and immediately post-intervention."||||0.011
91501098|NCT00385996|182872660|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Binomial distribution|Binomial distribution and test proportion =0.50||One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.||||<0.01
91501099|NCT00385996|182872662|OTHER||TTP [% without disease at 24 months]|63.6|||||TWO_SIDED|95.0|43.4|83.8|||||Using the Kaplan-Meier method.|One arm study||83.8|43.4|
91501100|NCT00385996|182872663|OTHER||% alive without disease at 25 months|72.7|||||TWO_SIDED|95.0|54.1|91.3|||||Using the Kaplan-Meier method.|One arm study||91.3|54.1|
91501101|NCT04008030|182872664|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||0.0003|TWO_SIDED|95.0|0.48|0.81||Boundary for statistical significance p-value \< 0.0095.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.81|0.48|0.0003
91501102|NCT04008030|182872665|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.14|0.32||Boundary for statistical significance p-value \< 0.0209.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.32|0.14|<0.0001
91745053|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.908|TWO_SIDED|95.0|-0.84|0.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.84|0.908
91745054|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.553|TWO_SIDED|95.0|-0.57|1.06|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.06|-0.57|0.553
91501103|NCT04008030|182872667|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
91501104|NCT04008030|182872668|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.32|||||TWO_SIDED|95.0|0.23|0.46|||||From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.46|0.23|
91531411|NCT04445155|182939424|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
91501105|NCT04008030|182872670|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.6||||||95.0|0.45|0.8|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.80|0.45|
91501106|NCT04008030|182872671|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.63||||||95.0|0.48|0.83|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.83|0.48|
91501107|NCT04008030|182872672|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
91745055|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.45|||<|0.001|TWO_SIDED|95.0|4.22|6.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.68|4.22|<0.001
91745056|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.1|||<|0.001|TWO_SIDED|95.0|3.88|6.31|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.31|3.88|<0.001
91745057|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.42|||<|0.001|TWO_SIDED|95.0|4.19|6.66|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.66|4.19|<0.001
91745058|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.17|||<|0.001|TWO_SIDED|95.0|3.94|6.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.40|3.94|<0.001
91745059|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.518|TWO_SIDED|95.0|-0.57|1.12|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|-0.57|0.518
91745060|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.86|TWO_SIDED|95.0|-0.9|0.75|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.90|0.860
91745061|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.556|TWO_SIDED|95.0|-0.59|1.1|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|-0.59|0.556
91501108|NCT04008030|182872673|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
91501109|NCT04008030|182872674|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64||||||95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
91501110|NCT04008030|182872675|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||||95.0|0.48|0.8|||||Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.80|0.48|
91501111|NCT04008030|182872677|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.77||||0.0011||95.0|1.26|2.5||Boundary for statistical significance p-value \< 0.006|Cochran-Mantel-Haenszel|Two-sided p-value from stratified CMH Test.|||Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT|2.50|1.26|0.0011
91501112|NCT04008030|182872678|SUPERIORITY|Arm B over Arm C|Odds Ratio (OR)|7.02||||||95.0|3.91|12.62|||||Stratified by tumor sidedness (left vs. right)|||12.62|3.91|
91501113|NCT04008030|182872678|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.67||||||95.0|1.06|2.63|||||Stratified by tumor sidedness (left vs. right)|||2.63|1.06|
91501114|NCT04008030|182872679|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||From a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.83|0.45|
91501115|NCT02574247|182872695|OTHER|||||||0.34|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -9 dB SNR||||0.34
91501116|NCT02574247|182872695|OTHER|||||||0.64|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -6 dB SNR||||0.64
91745062|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.44|||<|0.001|TWO_SIDED|95.0|4.17|6.71|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.71|4.17|<0.001
91745063|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.93|||<|0.001|TWO_SIDED|95.0|3.68|6.19|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.19|3.68|<0.001
91501117|NCT02574247|182872695|OTHER|||||||0.24|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -6 dB SNR||||0.24
91501118|NCT02574247|182872695|OTHER|||||||0.2|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -3 dB SNR||||0.20
91501119|NCT02574247|182872698|OTHER|||||||0.03|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM slope||||0.03
91745064|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.27|||<|0.001|TWO_SIDED|95.0|4.0|6.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.00|<0.001
91745065|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.06|||<|0.001|TWO_SIDED|95.0|3.79|6.34|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.34|3.79|<0.001
91745066|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.392|TWO_SIDED|95.0|-0.49|1.25|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|-0.49|0.392
91745067|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.762|TWO_SIDED|95.0|-0.98|0.72|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|-0.98|0.762
91745068|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.21||||0.638|TWO_SIDED|95.0|-0.66|1.08|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.66|0.638
91745069|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.55|||<|0.001|TWO_SIDED|95.0|3.2|5.9|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.90|3.20|<0.001
91745070|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.45|||<|0.001|TWO_SIDED|95.0|3.11|5.78|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.78|3.11|<0.001
91745071|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.91|||<|0.001|TWO_SIDED|95.0|3.56|6.26|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.26|3.56|<0.001
91745072|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.39|||<|0.001|TWO_SIDED|95.0|3.04|5.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.74|3.04|<0.001
91745073|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.741|TWO_SIDED|95.0|-0.77|1.08|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.77|0.741
91745074|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.05||||0.907|TWO_SIDED|95.0|-0.85|0.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|-0.85|0.907
91501120|NCT02574247|182872698|OTHER|||||||0.04|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for row IEEE slope||||0.04
91501121|NCT06273124|182872705|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|94.0|97.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||97|94|<0.001
91501122|NCT06273124|182872706|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|93.0|96.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||96|93|<0.001
91501123|NCT03336853|182872707|SUPERIORITY||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.82|||t-test, 2 sided|||||0.82|0.66|<.0001
91531412|NCT04445155|182939424|SUPERIORITY|||||||0.008|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.008
91531413|NCT04445155|182939425|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
91745075|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.274|TWO_SIDED|95.0|-0.41|1.44|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|-0.41|0.274
91745076|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.77|||<|0.001|TWO_SIDED|95.0|2.4|5.13|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.13|2.40|<0.001
91745077|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.91|||<|0.001|TWO_SIDED|95.0|2.56|5.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.26|2.56|<0.001
91745078|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.12|||<|0.001|TWO_SIDED|95.0|2.75|5.48|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.48|2.75|<0.001
91745079|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.01|||<|0.001|TWO_SIDED|95.0|2.64|5.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.38|2.64|<0.001
91745080|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.607|TWO_SIDED|95.0|-1.18|0.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.69|-1.18|0.607
91745081|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.824|TWO_SIDED|95.0|-1.02|0.81|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.02|0.824
91745082|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.827|TWO_SIDED|95.0|-0.83|1.04|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|-0.83|0.827
91501124|NCT01528254|182872708|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.45|0.58|||Regression, Cox|||||0.58|0.45|<0.001
91501125|NCT01528254|182872709|OTHER||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.042|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|||||0.00|-0.05|0.042
91501126|NCT01528254|182872710|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.635|TWO_SIDED|95.0|-0.29|0.47|||Mixed Models Analysis|||||0.47|-0.29|0.635
91501127|NCT01528254|182872711|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.53|TWO_SIDED|95.0|-0.05|0.02|||Mixed Models Analysis|||||0.02|-0.05|0.530
91501128|NCT01528254|182872712|OTHER||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.32||0.381|TWO_SIDED|95.0|-0.35|0.9|||Mixed Models Analysis|||||0.90|-0.35|0.381
91501129|NCT01528254|182872713|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.23||0.744|TWO_SIDED|95.0|-0.53|0.38|||Mixed Models Analysis|||From Week 13 to end of Period 1||0.38|-0.53|0.744
91501130|NCT01528254|182872713|OTHER||Slope|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.017|TWO_SIDED|95.0|-0.91|-0.09|||Mixed Models Analysis|||From Week 13 to end of Period 2||-0.09|-0.91|0.017
91531414|NCT04445155|182939425|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
91531415|NCT04445155|182939426|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
91501131|NCT01528254|182872713|OTHER||Slope|-0.58|STANDARD_ERROR_OF_MEAN|0.21||0.006|TWO_SIDED|95.0|-0.99|-0.17|||Mixed Models Analysis|||From Week 13 to end of study||-0.17|-0.99|0.006
91501132|NCT01528254|182872714|OTHER||Slope|-5.03|STANDARD_ERROR_OF_MEAN|2.16||0.02|TWO_SIDED|95.0|-9.26|-0.79|||Mixed Models Analysis|||From Week 13 to end of Period 1||-0.79|-9.26|0.020
91501133|NCT01528254|182872714|OTHER||Slope|-5.08|STANDARD_ERROR_OF_MEAN|1.73||0.003|TWO_SIDED|95.0|-8.46|-1.69|||Mixed Models Analysis|||From Week 13 to end of Period 2||-1.69|-8.46|0.003
91501134|NCT01528254|182872714|OTHER||Slope|-5.38|STANDARD_ERROR_OF_MEAN|1.64||0.001|TWO_SIDED|95.0|-8.61|-2.16|||Mixed Models Analysis|||From Week 13 to end of study||-2.16|-8.61|0.001
91501135|NCT00416078|182872759|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||F test of time X group effect F(1,3)=.26|Mixed Models Analysis|||intent to treat||||.65
91501136|NCT00416078|182872760|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||t test of differential change over time in the two groups t(30)=.67|Mixed Models Analysis|||intent to treat analysis||||.51
91501137|NCT00416078|182872761|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||t test of differential change over time in the two groups t(29)=.27|Mixed Models Analysis|||intent to treat analysis||||.79
91501138|NCT00416078|182872762|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.70|Mixed Models Analysis|||intent to treat analysis||||.49
91501139|NCT00416078|182872763|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.43|Mixed Models Analysis|||intent to treat analysis||||.67
91531416|NCT04445155|182939426|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
91745083|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.98|||<|0.001|TWO_SIDED|95.0|1.58|4.39|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.39|1.58|<0.001
91501140|NCT00416078|182872764|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||||||.64
91501141|NCT01686633|182872774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.045|0.171|||ANCOVA|||||0.171|0.045|<0.001
91501142|NCT01686633|182872774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.037|0.086||||||||0.086|-0.037|
91501143|NCT02607033|182872789|OTHER|Wilxocon signed Rank test||||||0.028|||||||Wilxocon signed Rank test|||Wilxocon signed Rank test to compare pre to post onset of pain time in the Exercise + Weight loss group. Due to low sample size were unable to compare changes between the Exercise + Weight Loss group and the Exercise only groups.||||0.028
91501144|NCT00773292|182872815|OTHER|change from baseline||||||0.24|||||||t-test, 2 sided|||||||0.24
91501145|NCT00708162|182872816|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-6.0|8.2|||||The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.|The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.||8.2|-6.0|
91501146|NCT00708162|182872817|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.|Difference in percentages|2.6|||||TWO_SIDED|95.0|-4.6|9.9|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.9|-4.6|
91501147|NCT00708162|182872818|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.0|7.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.7|-6.0|
91501148|NCT00708162|182872819|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.4|8.2|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||8.2|-6.4|
91501149|NCT00708162|182872820|SUPERIORITY_OR_OTHER||Difference in percentages|2.2|||||TWO_SIDED|95.0|-5.0|9.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.3|-5.0|
91501150|NCT00708162|182872821|SUPERIORITY_OR_OTHER||Difference in percentages|-0.5|||||TWO_SIDED|95.0|-7.9|6.8|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||6.8|-7.9|
91501151|NCT00708162|182872826|SUPERIORITY_OR_OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-6.9|7.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.3|-6.9|
91501152|NCT00708162|182872827|SUPERIORITY_OR_OTHER||Difference in percentages|-2.9|||||TWO_SIDED|95.0|-10.2|4.4|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.4|-10.2|
91501153|NCT00708162|182872828|SUPERIORITY_OR_OTHER||Difference in percentages|-2.0|||||TWO_SIDED|95.0|-8.6|4.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.7|-8.6|
91501154|NCT00708162|182872829|SUPERIORITY_OR_OTHER||Difference in percentages|-1.7|||||TWO_SIDED|95.0|-8.8|5.5|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||5.5|-8.8|
91501155|NCT00708162|182872830|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.01|||||TWO_SIDED|95.0|-0.16|0.19|||||The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.19|-0.16|
91501156|NCT00708162|182872831|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.05|||||TWO_SIDED|95.0|-0.12|0.22|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.22|-0.12|
91501157|NCT00708162|182872832|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|-9.0|||||TWO_SIDED|95.0|-33.0|16.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||16|-33|
91501158|NCT00708162|182872833|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|7.0|||||TWO_SIDED|95.0|-25.0|39.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||39|-25|
91501159|NCT00605813|182872882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.003
91501160|NCT00605813|182872883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
91501161|NCT00605813|182872884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders."||||0.040
91501162|NCT00605813|182872885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders."||||0.004
91531417|NCT00904150|182939443|SUPERIORITY_OR_OTHER|||||||0.513|||||||Chi-squared|||Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups||||0.513
91745084|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.27|||<|0.001|TWO_SIDED|95.0|1.88|4.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.65|1.88|<0.001
91745085|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.12|||<|0.001|TWO_SIDED|95.0|1.71|4.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.52|1.71|<0.001
91501163|NCT01163279|182872891|SUPERIORITY_OR_OTHER|||||||0.03||||||Statistical analysis applies to post intervention performance category|Chi-squared|||||||0.03
91501164|NCT01163279|182872891|SUPERIORITY_OR_OTHER|||||||0.32||||||Statistical analysis applies to post intervention satisfaction category|Chi-squared|||||||0.32
91501165|NCT01163279|182872891|SUPERIORITY_OR_OTHER|||||||0.54||||||Statistical analysis applies to 3-month follow up performance category|Chi-squared|||||||0.54
91501166|NCT01163279|182872891|SUPERIORITY_OR_OTHER|||||||0.26||||||Statistical analysis applies to 3-month follow up satisfaction category|Chi-squared|||||||0.26
91501167|NCT01163279|182872892|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
91501168|NCT01163279|182872893|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
91501169|NCT01163279|182872894|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
91501170|NCT01163279|182872895|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
91501171|NCT01163279|182872896|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
91501172|NCT01163279|182872896|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
91501173|NCT01163279|182872897|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.05
91501174|NCT01163279|182872897|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||>0.05
91501175|NCT01163279|182872898|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
91501176|NCT01163279|182872898|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
91501177|NCT01163279|182872899|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
91501178|NCT01163279|182872900|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||>0.05
91501179|NCT01163279|182872900|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
91501180|NCT01163279|182872901|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
91531418|NCT00904150|182939444|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups||||0.75
91531419|NCT00904150|182939445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.434||||0.002743||95.0|0.24|0.75|||Chi-squared|||Analysis of distribution of TNF genotype frequencies between groups||0.75|0.24|0.002743
91501181|NCT03227029|182872926|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|46.0|80.0|||||Proportions of study participants were calculated and presented with 90% exact confidence intervals. This highlights that we are 95% sure that the true proportion is not higher that the upper limit of the confidence interval.|||80|46|
91501182|NCT03227029|182872926|OTHER||% vaccine recipients with solicited AEs|84.0|||||TWO_SIDED|90.0|67.0|94.0||||||||94|67|
91501183|NCT03227029|182872926|OTHER||% placebo recipients with solicited AEs|58.0|||||TWO_SIDED|90.0|32.0|82.0||||||||82|32|
91501184|NCT03227029|182872927|OTHER||% vaccine recipients with usolicited AEs|36.0|||||TWO_SIDED|90.0|20.0|54.0||||||||54|20|
91531420|NCT00904150|182939446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.02462||95.0|0.49|0.95|||Chi-squared|||Analysis of distribution of SYNE1 genotype frequencies between groups||0.95|0.49|0.02462
91531421|NCT00904150|182939447|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups||||0.18
91531422|NCT00904150|182939448|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
91531423|NCT00904150|182939449|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
91531424|NCT01671748|182939450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.565|TWO_SIDED|95.0|-33.4|18.6||ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients' baseline (week 5) wound area was used as the covariate.|ANCOVA|||The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.||18.6|-33.4|0.565
91531425|NCT01671748|182939451|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANCOVA|||ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).||||0.490
91531426|NCT01671748|182939452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.08||||0.078|TWO_SIDED|95.0|-19.23|1.06|||ANCOVA|||ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).||1.06|-19.23|0.078
91531427|NCT01671748|182939453|SUPERIORITY_OR_OTHER|||||||0.346|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.||||0.346
91531428|NCT01671748|182939455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.618|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|Patients' baseline (week 5) wound area was used as the covariate.||||2.9|-4.7|0.618
91745086|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.57|||<|0.001|TWO_SIDED|95.0|2.16|4.98|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|2.16|<0.001
91501185|NCT03227029|182872927|OTHER||% vaccine recipients with usolicited AEs|52.0|||||TWO_SIDED|90.0|34.0|69.0||||||||69|34|
91501186|NCT03227029|182872927|OTHER||% placebo recipients with usolicited AEs|42.0|||||TWO_SIDED|90.0|18.0|68.0||||||||68|18|
91501187|NCT03227029|182872929|OTHER||% recipients infected with vaccine virus|88.0|||||TWO_SIDED|90.0|72.0|97.0||||||||97|72|
91501188|NCT03227029|182872929|OTHER||% recipients infected with vaccine virus|96.0|||||TWO_SIDED|90.0|82.0|100.0||||||||100|82|
91501189|NCT03227029|182872929|OTHER||% recipients infected with vaccine virus|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
91501190|NCT03227029|182872932|OTHER||% with >=4 fold rise in RSV-PRNT|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
91501191|NCT03227029|182872932|OTHER||% with >=4 fold rise in RSV-PRNT|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
91501192|NCT03227029|182872932|OTHER||% with >=4 fold rise in RSV-PRNT|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
91501193|NCT03227029|182872932|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
91501194|NCT03227029|182872932|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
91531429|NCT04191135|182939466|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4556|TWO_SIDED|95.0|0.72|1.33||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.33|0.72|0.4556
91531430|NCT04191135|182939467|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3903|TWO_SIDED|95.0|0.64|1.4||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.40|0.64|0.3903
91531431|NCT04191135|182939468|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.59|1.43|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.43|0.59|
91531432|NCT04191135|182939469|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.53|1.76|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.76|0.53|
91531433|NCT04191135|182939470|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.33|1.48|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||1.48|0.33|
91531434|NCT04191135|182939471|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.28|2.37|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||2.37|0.28|
91501195|NCT03227029|182872933|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
91501196|NCT03227029|182872933|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
91501197|NCT03227029|182872934|OTHER||% with >=4 fold rise in RSV F protein|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
91501198|NCT03227029|182872934|OTHER||% with >=4 fold rise in RSV F protein|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
91501199|NCT03227029|182872934|OTHER||% with >=4 fold rise in RSV F protein|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
91501200|NCT03227029|182872934|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
91501201|NCT03227029|182872934|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
91501202|NCT03227029|182872935|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
91501203|NCT03227029|182872935|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
91745087|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.59||||0.232|TWO_SIDED|95.0|-1.55|0.38|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.55|0.232
91745088|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.31||||0.522|TWO_SIDED|95.0|-1.24|0.63|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-1.24|0.522
91745089|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.356|TWO_SIDED|95.0|-1.41|0.51|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-1.41|0.356
91501204|NCT01291173|182872938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014||||0.8825|TWO_SIDED|95.0|-0.203|0.175|||Mixed Models Analysis|||||0.175|-0.203|0.8825
91501205|NCT01291173|182872938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258||||0.0077|TWO_SIDED|95.0|-0.446|-0.069|||Mixed Models Analysis|||||-0.069|-0.446|0.0077
91501206|NCT01291173|182872938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.345||||0.0004|TWO_SIDED|95.0|-0.534|-0.155|||Mixed Models Analysis|||||-0.155|-0.534|0.0004
91501207|NCT01291173|182872939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4676|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.4676
91501208|NCT01291173|182872939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0198|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0198
91501209|NCT01291173|182872939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0031
91501210|NCT01291173|182872940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3341|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.3341
91501211|NCT01291173|182872940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
91501212|NCT01291173|182872940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0022
91501213|NCT01291173|182872941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0937|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0937
91501214|NCT01291173|182872941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0127
91501215|NCT01291173|182872941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0009
91501216|NCT01291173|182872944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091|TWO_SIDED|95.0|||||Chi-squared|||||||0.0091
91501217|NCT01291173|182872944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|95.0|||||Chi-squared|||||||0.0004
91501218|NCT01291173|182872944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||||||<0.0001
91501219|NCT01291173|182872945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.97||||0.0142|TWO_SIDED|95.0|-5.34|-0.6|||Mixed Models Analysis|||||-0.60|-5.34|0.0142
91501220|NCT01291173|182872945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.25||||0.0075|TWO_SIDED|95.0|-5.62|-0.88|||Mixed Models Analysis|||||-0.88|-5.62|0.0075
91501221|NCT01291173|182872945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.93|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.56|||Mixed Models Analysis|||||-2.56|-7.30|<0.0001
91501222|NCT01291173|182872946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.7538|TWO_SIDED|95.0|-1.11|0.8|||Mixed Models Analysis|||||0.80|-1.11|0.7538
91501223|NCT01291173|182872946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49||||0.3062|TWO_SIDED|95.0|-0.45|1.44|||Mixed Models Analysis|||||1.44|-0.45|0.3062
91501224|NCT01291173|182872946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.7697|TWO_SIDED|95.0|-0.81|1.09|||Mixed Models Analysis|||||1.09|-0.81|0.7697
91501225|NCT01291173|182872947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53||||0.2046|TWO_SIDED|95.0|-0.29|1.35|||Mixed Models Analysis|||||1.35|-0.29|0.2046
91501226|NCT01291173|182872947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3348|TWO_SIDED|95.0|-0.42|1.22|||Mixed Models Analysis|||||1.22|-0.42|0.3348
91501227|NCT01291173|182872947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81||||0.0505|TWO_SIDED|95.0|0.0|1.63|||Mixed Models Analysis|||||1.63|-0.00|0.0505
91501228|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0371|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0371
91501229|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.1380
91501230|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0459
91501231|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0278
91501232|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0022
91501233|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||<0.0001
91501234|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0149|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0149
91501235|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0009
91531435|NCT04191135|182939472|SUPERIORITY||Difference in Least Squares Means|-3.28||||0.143|TWO_SIDED|95.0|-7.69|1.12|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||1.12|-7.69|0.1430
91531436|NCT04191135|182939473|SUPERIORITY||Difference in Least Squares Means|-0.16||||0.9454|TWO_SIDED|95.0|-4.89|4.56|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.56|-4.89|0.9454
91531437|NCT04191135|182939474|SUPERIORITY||Difference in Least Squares Means|2.08||||0.4351|TWO_SIDED|95.0|-3.16|7.31|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||7.31|-3.16|0.4351
91531438|NCT04191135|182939475|SUPERIORITY||Difference in Least Squares Means|0.93||||0.5588|TWO_SIDED|95.0|-2.2|4.06|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.06|-2.20|0.5588
91501236|NCT01291173|182872948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||<0.0001
91501237|NCT01291173|182872949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9||||0.03|TWO_SIDED|95.0|-7.44|-0.38|||Mixed Models Analysis|||||-0.38|-7.44|0.030
91501238|NCT01291173|182872949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||0.002|TWO_SIDED|95.0|-8.95|-1.94|||Mixed Models Analysis|||||-1.94|-8.95|0.002
91501239|NCT01291173|182872949|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-11.99|-4.92|||Mixed Models Analysis|||||-4.92|-11.99|<0.001
91501240|NCT01291173|182872950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.65||||0.0824|TWO_SIDED|95.0|-5.64|0.34|||Mixed Models Analysis|||||0.34|-5.64|0.0824
91501241|NCT01291173|182872950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07||||0.1725|TWO_SIDED|95.0|-5.05|0.91|||Mixed Models Analysis|||||0.91|-5.05|0.1725
91501242|NCT01291173|182872950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.71||||0.0148|TWO_SIDED|95.0|-6.69|-0.73|||Mixed Models Analysis|||||-0.73|-6.69|0.0148
91501243|NCT01291173|182872951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.2504|TWO_SIDED|95.0|-0.89|3.38|||Mixed Models Analysis|||Aggregate Physical Score||3.38|-0.89|0.2504
91501244|NCT01291173|182872951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.09||||0.309|TWO_SIDED|95.0|-1.02|3.21|||Mixed Models Analysis|||Aggregate Physical Score||3.21|-1.02|0.3090
91501245|NCT01291173|182872951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0216|TWO_SIDED|95.0|0.37|4.64|||Mixed Models Analysis|||Aggregate Physical Score||4.64|0.37|0.0216
91501246|NCT01291173|182872951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.9587|TWO_SIDED|95.0|-2.75|2.9|||Mixed Models Analysis|||Aggregate Mental Score||2.90|-2.75|0.9587
91501247|NCT01291173|182872951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.653|TWO_SIDED|95.0|-2.17|3.45|||Mixed Models Analysis|||Aggregate Mental Score||3.45|-2.17|0.6530
91501248|NCT01291173|182872951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9814|TWO_SIDED|95.0|-2.79|2.86|||Mixed Models Analysis|||Aggregate Mental Score||2.86|-2.79|0.9814
91501249|NCT01074450|182872961|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.93|||||TWO_SIDED|90.0|94.23|108.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.1|94.23|
91501250|NCT01074450|182872962|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.71|||||TWO_SIDED|90.0|99.74|109.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.92|99.74|
91501251|NCT01074450|182872963|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.15|||||TWO_SIDED|90.0|99.05|109.52|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.52|99.05|
91531439|NCT04191135|182939476|SUPERIORITY||Difference in Least Squares Means|-0.37||||0.8408|TWO_SIDED|95.0|-4.03|3.28|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.28|-4.03|0.8408
91531440|NCT04191135|182939477|SUPERIORITY||Difference in Least Squares Means|-1.34||||0.795|TWO_SIDED|95.0|-11.63|8.95|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||8.95|-11.63|0.7950
91531441|NCT04191135|182939478|SUPERIORITY||Difference in Least Squares Means|4.82||||0.1597|TWO_SIDED|95.0|-1.97|11.62|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||11.62|-1.97|0.1597
91501252|NCT04788953|182872981|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects tobit regression model (censored normal). Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||The statistical null hypothesis was that solriamfetol does not improve change in MWT scores versus placebo after 4 weeks of treatment (H0: µsol - µpl ≤ 0). Study was designed to have 97% power to detect a difference of 5.7 minutes or greater on MWT sleep latency (α=0.05, assumed σ=7.2) with 100 participants. Blinded interim power analysis on the baseline data conducted in October 2023 indicated the trial would have \>99% power to detect a similar difference with only 74 participants.||||<0.001
91501253|NCT04788953|182872982|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
91501254|NCT04788953|182872983|SUPERIORITY|||||||0.01||||||"Chi-squared tests performed on dichotomized CGI-Change data (Improved \[very much improved, much improved, minimally improved\] vs. Not Improved \[no change, minimally worse, much worse, very much worse\])."|Chi-squared|P-value is difference between groups.||||||0.01
91501255|NCT04788953|182872985|SUPERIORITY|Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.||||||0.02|||||||Mixed Models Analysis|P-value is difference between groups.||||||0.02
91501256|NCT04788953|182872986|SUPERIORITY|||||||0.64||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.64
91501257|NCT04788953|182872987|SUPERIORITY|||||||0.04||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.04
91501258|NCT04788953|182872988|SUPERIORITY|||||||0.61||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.61
91501259|NCT04788953|182872989|SUPERIORITY|||||||0.57||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.57
91531442|NCT04191135|182939479|SUPERIORITY||Difference in Least Squares Means|2.52||||0.6138|TWO_SIDED|95.0|-7.45|12.49|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.49|-7.45|0.6138
91531443|NCT04191135|182939480|SUPERIORITY||Difference in Least Squares Means|-1.6||||0.5567|TWO_SIDED|95.0|-7.02|3.83|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.83|-7.02|0.5567
91531444|NCT04191135|182939481|SUPERIORITY||Difference in Least Squares Means|5.56||||0.105|TWO_SIDED|95.0|-1.2|12.32|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.32|-1.20|0.1050
91745090|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.31||||0.001|TWO_SIDED|95.0|0.92|3.69|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.69|0.92|0.001
91501260|NCT04788953|182872990|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
91501261|NCT00469092|182872991|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.|Mean Difference (Net)|-0.16||||0.029||95.0|-0.3|-0.02||P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.|Regression, Linear|||HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.||-0.02|-0.30|0.029
91501262|NCT00469092|182872992|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.|Mixed Models Analysis|||The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.||||0.0059
91501263|NCT00469092|182872993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.914||||||95.0|0.57|1.47|||||The OR and 95% CI is for the HbA1c \<= 6.5% treatment target.|||1.47|0.57|
91501264|NCT00469092|182872993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||||95.0|0.67|1.54|||||The OR and 95% CI is for the HbA1c \< 7.0% treatment target.|||1.54|0.67|
91501265|NCT00469092|182872993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||||95.0|0.72|1.77|||||The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.|||1.77|0.72|
91501266|NCT00469092|182872993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.905||||||95.0|0.59|1.38|||||The OR and 95% CI is for the HbA1c \< 7% no nocturnal (00:00-06:00) hypoglycemia treatment target|||1.38|0.59|
91531445|NCT04191135|182939482|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.00676|TWO_SIDED|95.0|1.16|2.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||2.71|1.16|0.00676
91501267|NCT00469092|182872993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.181||||||95.0|0.74|1.87|||||The OR and 95% CI is for the HbA1c \< 7%, no daytime (06:01-23:59) hypoglycemia treatment target|||1.87|0.74|
91501268|NCT00469092|182872993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.122||||||95.0|0.69|1.82|||||The OR and 95% CI is for the HbA1c \< 7%, no hypoglycemia treatment target.|||1.82|0.69|
91501269|NCT00469092|182872994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||||95.0|-2.4|2.48|||||The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.48|-2.40|
91501270|NCT00469092|182872994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||||95.0|-3.56|3.11|||||The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||3.11|-3.56|
91501271|NCT00469092|182872994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||||95.0|-3.14|2.35|||||The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.35|-3.14|
91501272|NCT00469092|182872994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||||95.0|-2.36|2.14|||Regression, Linear||The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.14|-2.36|
91501273|NCT01086540|182873002|SUPERIORITY||Median Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|14.71||0.12|TWO_SIDED||||||Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|The null hypothesis was that the mean change in 6MWD between baseline and Week 24 does not differ between rituximab and placebo. A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 24.||||0.12
91501274|NCT01086540|182873003|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with PVR as the outcome and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
91531446|NCT04191135|182939483|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96425|TWO_SIDED|95.0|0.61|1.69|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.69|0.61|0.96425
91745091|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.45|||<|0.001|TWO_SIDED|95.0|1.08|3.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.82|1.08|<0.001
91745092|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.31|4.08|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.08|1.31|<0.001
91501275|NCT01086540|182873004|SUPERIORITY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|15.1||0.28|TWO_SIDED|||||Week 48 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.28
91501276|NCT01086540|182873004|SUPERIORITY||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|11.5||0.031|TWO_SIDED|||||Week 24 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.031
91501277|NCT01086540|182873005|SUPERIORITY|||||||0.92||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to clinical worsening were compared using a log-rank test.||||0.92
91531447|NCT04191135|182939484|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.74965|TWO_SIDED|95.0|0.69|1.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.71|0.69|0.74965
91501278|NCT01086540|182873006|SUPERIORITY|||||||0.36||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to change or addition of PAH medications were compared using a log-rank test.||||0.36
91501279|NCT01086540|182873007|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||0.81|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the mental component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.81
91501280|NCT01086540|182873008|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.1||0.3|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the physical component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.30
91745093|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.85|||<|0.001|TWO_SIDED|95.0|1.46|4.23|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.23|1.46|<0.001
91745094|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.264|TWO_SIDED|95.0|-1.49|0.41|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-1.49|0.264
91745095|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.4||||0.4|TWO_SIDED|95.0|-1.32|0.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.32|0.400
91745096|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.758|TWO_SIDED|95.0|-1.1|0.8|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-1.10|0.758
91745097|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.62||||0.018|TWO_SIDED|95.0|0.27|2.97|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|0.27|0.018
91745098|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.88||||0.006|TWO_SIDED|95.0|0.55|3.21|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.21|0.55|0.006
91745099|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.29|||<|0.001|TWO_SIDED|95.0|0.94|3.63|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.63|0.94|<0.001
91745100|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.05|3.75|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.75|1.05|<0.001
91745101|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.097|TWO_SIDED|95.0|-1.7|0.14|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-1.70|0.097
91745102|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.52||||0.254|TWO_SIDED|95.0|-1.42|0.38|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.42|0.254
91745103|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.812|TWO_SIDED|95.0|-1.03|0.81|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.03|0.812
91745104|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32||||0.045|TWO_SIDED|95.0|0.03|2.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.61|0.03|0.045
91745105|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.015|TWO_SIDED|95.0|0.31|2.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.87|0.31|0.015
91745106|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.73||||0.009|TWO_SIDED|95.0|0.43|3.02|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.02|0.43|0.009
91745107|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.08||||0.002|TWO_SIDED|95.0|0.78|3.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.37|0.78|0.002
91745108|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.76||||0.094|TWO_SIDED|95.0|-1.64|0.13|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-1.64|0.094
91501281|NCT01086540|182873009|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with HAQ-DI as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.58
91501282|NCT01086540|182873010|SUPERIORITY|||||||0.47||||||P-values not adjusted for multiple comparisons.|Regression, Linear|||A Poisson model was used to describe the rate of new digital ulcers (per week) as the outcome with treatment, number of digital ulcers at Baseline, and if the measurement was affected by changed or new PAH therapeutic agents as covariates.||||0.47
91501283|NCT01086540|182873011|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|5.7||0.43|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with severity of Raynaud's (0 to 100) as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.43
91501284|NCT01086540|182873012|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with DLCO as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.65
91531448|NCT04191135|182939485|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.10502|TWO_SIDED|95.0|0.88|3.53|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||3.53|0.88|0.10502
91531449|NCT04191135|182939486|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.5019|TWO_SIDED|95.0|0.57|3.0|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||3.00|0.57|0.50190
91531450|NCT04191135|182939487|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.47384|TWO_SIDED|95.0|0.24|1.97|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||1.97|0.24|0.47384
91531451|NCT04191135|182939488|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.81463|TWO_SIDED|95.0|0.33|2.38|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||2.38|0.33|0.81463
91531452|NCT04191135|182939489|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.67255|TWO_SIDED|95.0|0.24|8.82|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||8.82|0.24|0.67255
91531453|NCT02107274|182939492|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91745109|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.269|TWO_SIDED|95.0|-1.35|0.38|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.35|0.269
91745110|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.437|TWO_SIDED|95.0|-1.23|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.23|0.437
91531454|NCT02107274|182939492|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91531455|NCT02107274|182939493|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91531456|NCT02107274|182939493|SUPERIORITY_OR_OTHER||||||<|0.01||||||p valu of less than 0.05 was considered significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables"||||<0.01
91531457|NCT02107274|182939494|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91531458|NCT02107274|182939494|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91531459|NCT02107274|182939495|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91501285|NCT01086540|182873014|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.7||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with percent change in PVR as the outcome and baseline PVR, treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
91745111|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.218|TWO_SIDED|95.0|-0.44|1.92|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.92|-0.44|0.218
91501286|NCT01086540|182873019|SUPERIORITY|||||||0.17||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.17
91501287|NCT01086540|182873020|SUPERIORITY|||||||0.35||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.35
91501288|NCT02707991|182873021|SUPERIORITY||Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|0.115||0.036|ONE_SIDED|||||one-sided test|z-test for difference in proportions|||||||0.036
91501289|NCT02612428|182873046|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.762|TWO_SIDED|95.0|0.509|1.64|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.640|0.509|0.762
91531460|NCT02107274|182939495|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
91745112|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.046|TWO_SIDED|95.0|0.02|2.35|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.35|0.02|0.046
91745113|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.03|TWO_SIDED|95.0|0.13|2.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.49|0.13|0.030
91745114|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.75||||0.004|TWO_SIDED|95.0|0.57|2.93|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.93|0.57|0.004
91745115|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.01||||0.014|TWO_SIDED|95.0|-1.82|-0.2|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.20|-1.82|0.014
91745116|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.16|TWO_SIDED|95.0|-1.35|0.22|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-1.35|0.160
91745117|NCT01559259|183384895|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.284|TWO_SIDED|95.0|-1.25|0.37|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-1.25|0.284
91745118|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.62||||0.014|TWO_SIDED|95.0|0.13|1.1|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.13|0.014
91745119|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.46||||0.066|TWO_SIDED|95.0|-0.03|0.94|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.94|-0.03|0.066
91745120|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.004|TWO_SIDED|95.0|0.22|1.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.20|0.22|0.004
91745121|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.232|TWO_SIDED|95.0|-0.19|0.78|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.19|0.232
91745122|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.32||||0.067|TWO_SIDED|95.0|-0.02|0.66|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.02|0.067
91501290|NCT02612428|182873047|SUPERIORITY|||||||0.6829|||||||Chi-squared|||||||0.6829
91501291|NCT02612428|182873048|SUPERIORITY|||||||0.048|||||||Chi-squared|||||||0.048
91501292|NCT01928329|182873057|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.0816|TWO_SIDED|95.0|-0.5|0.03||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.03|-0.50|0.0816
91501293|NCT01928329|182873058|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.912|TWO_SIDED|95.0|-0.28|0.25||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.25|-0.28|0.912
91501294|NCT01928329|182873059|SUPERIORITY||Z score|-0.801||||0.423|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.423
91501295|NCT01928329|182873060|SUPERIORITY||Z score|-1.312||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.189
91501296|NCT05167734|182873070|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.02|TWO_SIDED|95.0|0.1|1.2|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|values greater than 0 infer higher hemoglobin in active intervention|||1.2|0.1|0.02
91501297|NCT05167734|182873071|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.0|1.1|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|adjusted mean difference|3-months post hospitalization||1.1|0.0|0.04
91501298|NCT05167734|182873071|SUPERIORITY||Mean Difference (Net)|0.2||||0.42|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission||Hospital Discharge||0.7|-0.3|0.42
91501299|NCT05167734|182873072|SUPERIORITY|||||||0.352|||||||Mixed Models Analysis|||||||0.352
91501300|NCT05167734|182873073|SUPERIORITY||||||<|0.001||||||threshold for significance - p\<0.05|Mixed Models Analysis|||||||<0.001
91745123|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.354|TWO_SIDED|95.0|-0.18|0.5|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.18|0.354
91745124|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.017|TWO_SIDED|95.0|0.08|0.76|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.76|0.08|0.017
91745125|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.45|2.86|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.45|<0.001
91745126|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.93|||<|0.001|TWO_SIDED|95.0|1.23|2.64|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.64|1.23|<0.001
91745127|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.39|2.8|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.80|1.39|<0.001
91745128|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.02|0.61|<0.001
91745129|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83|||<|0.001|TWO_SIDED|95.0|0.34|1.33|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.34|<0.001
91745130|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.62||||0.014|TWO_SIDED|95.0|0.12|1.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.11|0.12|0.014
91745131|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|0.28|0.002
91745132|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.45|||<|0.001|TWO_SIDED|95.0|2.69|4.22|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.22|2.69|<0.001
91745133|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.13|||<|0.001|TWO_SIDED|95.0|2.36|3.89|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.89|2.36|<0.001
91501301|NCT05167734|182873074|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.44|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital Discharge||2.40|0.44|0.94
91501302|NCT05167734|182873074|SUPERIORITY||Odds Ratio (OR)|1.79||||0.18|TWO_SIDED|95.0|0.76|4.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||4.20|0.76|0.18
91501303|NCT05167734|182873074|SUPERIORITY||Odds Ratio (OR)|1.23||||0.64|TWO_SIDED|95.0|0.51|3.0|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||3.00|0.51|0.64
91501304|NCT05167734|182873075|SUPERIORITY||Odds Ratio (OR)|1.81||||0.23|TWO_SIDED|95.0|0.68|4.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital discharge||4.80|0.68|0.23
91501305|NCT05167734|182873075|SUPERIORITY||Odds Ratio (OR)|2.43||||0.09|TWO_SIDED|95.0|0.87|6.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||6.80|0.87|0.09
91501306|NCT05167734|182873075|SUPERIORITY||Odds Ratio (OR)|2.52||||0.084|TWO_SIDED|95.0|0.88|7.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||7.20|0.88|0.084
91745134|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.49|||<|0.001|TWO_SIDED|95.0|2.72|4.26|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.72|<0.001
91745135|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.78|||<|0.001|TWO_SIDED|95.0|2.02|3.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.54|2.02|<0.001
91745136|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.14|0.014
91745137|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.35||||0.202|TWO_SIDED|95.0|-0.19|0.88|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.88|-0.19|0.202
91745138|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.01|TWO_SIDED|95.0|0.17|1.24|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.17|0.010
91745139|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.0|||<|0.001|TWO_SIDED|95.0|3.24|4.76|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.76|3.24|<0.001
91745140|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.55|||<|0.001|TWO_SIDED|95.0|2.79|4.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.31|2.79|<0.001
91745141|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.03|||<|0.001|TWO_SIDED|95.0|3.27|4.79|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|3.27|<0.001
91745142|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.48|||<|0.001|TWO_SIDED|95.0|2.72|4.24|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.24|2.72|<0.001
91745143|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.056|TWO_SIDED|95.0|-0.01|1.05|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.05|-0.01|0.056
91501307|NCT05167734|182873076|SUPERIORITY||Mean Difference (Net)|218.0||||0.13|TWO_SIDED|95.0|-73.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, and baseline ADLs|scores greater than 0 reflect greater ambulatory distance in active intervention|1-month post hospitalization||510|-73|0.13
91501308|NCT05167734|182873076|SUPERIORITY||Median Difference (Net)|178.0||||0.27|TWO_SIDED|95.0|-154.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs||3-months post hospitalization||510|-154|0.27
91745144|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.789|TWO_SIDED|95.0|-0.46|0.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.46|0.789
91501309|NCT05167734|182873077|SUPERIORITY||Odds Ratio (OR)|2.49||||0.12|TWO_SIDED|95.0|0.79|7.8|||proportional odds|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||7.80|0.79|0.12
91501310|NCT05167734|182873077|SUPERIORITY||Odds Ratio (OR)|3.1||||0.07|TWO_SIDED|95.0|0.91|10.5|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||10.5|0.91|0.07
91745145|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.042|TWO_SIDED|95.0|0.02|1.08|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|0.02|0.042
91745146|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.37|4.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|3.37|<0.001
91501311|NCT05167734|182873078|SUPERIORITY||Odds Ratio (OR)|0.5||||0.29|TWO_SIDED|95.0|0.14|1.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for anxiety score||1.80|0.14|0.29
91501312|NCT05167734|182873078|SUPERIORITY||Odds Ratio (OR)|0.68||||0.57|TWO_SIDED|95.0|0.18|2.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for anxiety score||2.60|0.18|0.57
91531461|NCT03251144|182939496|OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91531462|NCT05305040|182939497|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.5603|TWO_SIDED|95.0|-0.09|0.1||1-sided p-value|ANCOVA|||||0.10|-0.09|0.5603
91531463|NCT01195675|182939502|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.69|1.87|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.87|-0.69|
91531464|NCT01195675|182939503|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-0.38|1.71|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.71|-0.38|
91531465|NCT01195675|182939504|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.23|0.93|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.93|-1.23|
91745147|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.86|||<|0.001|TWO_SIDED|95.0|3.06|4.66|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.66|3.06|<0.001
91745148|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.34|||<|0.001|TWO_SIDED|95.0|3.54|5.14|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.14|3.54|<0.001
91745149|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.09|4.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.69|3.09|<0.001
91531466|NCT01195675|182939505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|90.0|10.73|14.11|||ANCOVA|Based on ANCOVA with terms for treatment, period, treatment sequence, baseline and subject within sequence.|Non-confirmatory testing. Mean difference = Moxifloxacin minus placebo.|||14.11|10.73|<0.0001
91531467|NCT01195675|182939506|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.34|4.67|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||4.67|-0.34|
91531468|NCT01195675|182939507|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.35|3.53|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||3.53|-0.35|
91531469|NCT01195675|182939508|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-1.39|0.94|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.94|-1.39|
91531470|NCT00354029|182939544|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
91531471|NCT02033993|182939545|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.31|TWO_SIDED|90.0|0.68|1.23||1-sided p-value|Log Rank|||||1.23|0.68|0.31
91531472|NCT02033993|182939546|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.4|TWO_SIDED|90.0|0.7|1.3||1-sided p-value|Log Rank|||||1.30|0.70|0.40
91531473|NCT02033993|182939547|SUPERIORITY||Odds Ratio (OR)|1.41||||0.28|TWO_SIDED|95.0|0.76|2.59|||Cochran-Mantel-Haenszel|||||2.59|0.76|0.28
91531474|NCT02033993|182939548|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.54|TWO_SIDED|95.0|0.46|1.51|||Log Rank|||||1.51|0.46|0.54
91535616|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.31||0.8184|TWO_SIDED|95.0|-0.69|0.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.55|-0.69|0.8184
91745150|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.317|TWO_SIDED|95.0|-0.28|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.28|0.317
91745151|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.922|TWO_SIDED|95.0|-0.59|0.53|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.59|0.922
91745152|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.112|TWO_SIDED|95.0|-0.11|1.02|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.11|0.112
91501313|NCT05167734|182873078|SUPERIORITY||Odds Ratio (OR)|0.36||||0.12|TWO_SIDED|95.0|0.1|1.3|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for depression score||1.30|0.10|0.12
91501314|NCT05167734|182873078|SUPERIORITY||Odds Ratio (OR)|0.62||||0.48|TWO_SIDED|95.0|0.16|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for depression score||2.40|0.16|0.48
91531475|NCT02096081|182939582|NON_INFERIORITY_OR_EQUIVALENCE|"The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group. The hypothesis testing procedure to test the equivalence of the two products is as follows:~Ho (null): D ≤ -∆ OR D ≥ ∆ versus Ha (alternate): -∆ \< D \< ∆, where ∆ is the margin of equivalence = 0.15."|Difference in proportions of response|-3.5|||||TWO_SIDED|95.0|-7.5|0.6|||||If the confidence interval lies within the limits of ±0.15, then Ho is rejected in favor of Ha (i.e., equivalence of incobotulinumtoxinA and onabotulinumtoxinA can be concluded); otherwise, treatment equivalence cannot be concluded.|With assumptions of an alpha of 5%, an equivalence margin of 15% for each side, the real response rate expected as 90% for incobotulinumtoxinA and onabotulinumtoxinA at day 30 and a 1:1 allocation ratio, a total of 225 subjects were needed to achieve a statistical power of 90% in order to make an equivalence conclusion at day 30. Results are based on the Newcombe-Wilson confidence interval. To account for exclusions from the PPS of about 10%, approximately 250 subjects were enrolled.||0.6|-7.5|
91745153|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.27|4.94|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.94|3.27|<0.001
91501315|NCT05167734|182873079|SUPERIORITY||Odds Ratio (OR)|1.48||||0.56|TWO_SIDED|95.0|0.39|5.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||5.60|0.39|0.56
91745154|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.76|||<|0.001|TWO_SIDED|95.0|2.92|4.59|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.59|2.92|<0.001
91745155|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.15|||<|0.001|TWO_SIDED|95.0|3.32|4.99|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.99|3.32|<0.001
91745156|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.05|4.72|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.72|3.05|<0.001
91745157|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.464|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-0.37|0.464
91745158|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.667|TWO_SIDED|95.0|-0.71|0.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.71|0.667
91745159|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.368|TWO_SIDED|95.0|-0.32|0.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.32|0.368
91745160|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.94|||<|0.001|TWO_SIDED|95.0|3.08|4.81|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.81|3.08|<0.001
91745161|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.63|||<|0.001|TWO_SIDED|95.0|2.77|4.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.49|2.77|<0.001
91745162|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.19|4.92|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.92|3.19|<0.001
91745163|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.54|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.54|2.82|<0.001
91745164|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.397|TWO_SIDED|95.0|-0.34|0.86|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.34|0.397
91745165|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.866|TWO_SIDED|95.0|-0.65|0.55|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.65|0.866
91501316|NCT05167734|182873079|SUPERIORITY||Odds Ratio (OR)|9.16||||0.02|TWO_SIDED|95.0|1.4|59.9|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||59.9|1.40|0.02
91501317|NCT05167734|182873080|SUPERIORITY||Odds Ratio (OR)|0.16||||0.09|TWO_SIDED|95.0|0.02|1.4|||Regression, Logistic|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|||1.40|0.02|0.09
91745166|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.226|TWO_SIDED|95.0|-0.23|0.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|-0.23|0.226
91745167|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.8|||<|0.001|TWO_SIDED|95.0|2.9|4.7|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.70|2.90|<0.001
91745168|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.47|4.26|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.47|<0.001
91745169|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|2.99|4.79|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|2.99|<0.001
91745170|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.6|||<|0.001|TWO_SIDED|95.0|2.7|4.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.50|2.70|<0.001
91745171|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.536|TWO_SIDED|95.0|-0.43|0.83|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.43|0.536
91501318|NCT05167734|182873082|SUPERIORITY||Odds Ratio (OR)|0.73||||0.48|TWO_SIDED|95.0|0.3|1.8|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||1.80|0.30|0.48
91501319|NCT05167734|182873083|SUPERIORITY||Odds Ratio (OR)|2.13||||0.54|TWO_SIDED|95.0|0.19|24.0|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||24.0|0.19|0.54
91745172|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.467|TWO_SIDED|95.0|-0.86|0.39|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.86|0.467
91745173|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.361|TWO_SIDED|95.0|-0.34|0.92|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|-0.34|0.361
91745174|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.17|||<|0.001|TWO_SIDED|95.0|2.21|4.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.13|2.21|<0.001
91745175|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.04|3.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.95|2.04|<0.001
91745176|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.51|||<|0.001|TWO_SIDED|95.0|2.55|4.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.47|2.55|<0.001
91745177|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.09|4.0|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.00|2.09|<0.001
91501320|NCT03742037|182873116|SUPERIORITY||LS mean difference to placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.54||0.4749|TWO_SIDED|95.0|-1.45|0.68|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.68|-1.45|0.4749
91501321|NCT03742037|182873116|SUPERIORITY||LS mean to placebo|-0.57|STANDARD_ERROR_OF_MEAN|0.54||0.2941|TWO_SIDED|95.0|-1.65|0.49|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.49|-1.65|0.2941
91501322|NCT03742037|182873116|SUPERIORITY||LS mean difference to placebo|0.01|STANDARD_ERROR_OF_MEAN|0.54||0.9802|TWO_SIDED|95.0|-1.05|1.08|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||1.08|-1.05|0.9802
91501323|NCT03742037|182873116|SUPERIORITY||LS mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.54||0.0291|TWO_SIDED|95.0|-2.25|-0.12|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||-0.12|-2.25|0.0291
91531476|NCT02096081|182939583|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.3|||||TWO_SIDED|95.0|-12.1|1.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||1.5|-12.1|
91531477|NCT02096081|182939584|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-0.5|||||TWO_SIDED|95.0|-10.6|9.6|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.6|-10.6|
91745178|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.704|TWO_SIDED|95.0|-0.54|0.8|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-0.54|0.704
91745179|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.89|TWO_SIDED|95.0|-0.71|0.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.62|-0.71|0.890
91745180|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.17|TWO_SIDED|95.0|-0.2|1.14|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.14|-0.20|0.170
91745181|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.72|3.67|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.67|1.72|<0.001
91745182|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.58|||<|0.001|TWO_SIDED|95.0|1.61|3.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.56|1.61|<0.001
91745183|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.01|3.97|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.97|2.01|<0.001
91501324|NCT03742037|182873117|SUPERIORITY||Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||1.9|0.54|0.974
91531478|NCT02096081|182939585|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.2|||||TWO_SIDED|95.0|-17.4|7.1|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||7.1|-17.4|
91745184|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.75|||<|0.001|TWO_SIDED|95.0|1.77|3.72|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.72|1.77|<0.001
91745185|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.882|TWO_SIDED|95.0|-0.74|0.63|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-0.74|0.882
91745186|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.16||||0.64|TWO_SIDED|95.0|-0.84|0.52|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.84|0.640
91745187|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.482|TWO_SIDED|95.0|-0.44|0.93|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|-0.44|0.482
91745188|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.06|||<|0.001|TWO_SIDED|95.0|1.07|3.06|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.06|1.07|<0.001
91501325|NCT03742037|182873117|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2845|TWO_SIDED|95.0|0.75|2.65|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.65|0.75|0.2845
91501326|NCT03742037|182873117|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
91501327|NCT03742037|182873117|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
91745189|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.17|3.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.16|1.17|<0.001
91745190|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.24|||<|0.001|TWO_SIDED|95.0|1.25|3.24|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.24|1.25|<0.001
91745191|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.42|||<|0.001|TWO_SIDED|95.0|1.43|3.41|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.41|1.43|<0.001
91745192|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.314|TWO_SIDED|95.0|-1.05|0.34|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-1.05|0.314
91745193|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.469|TWO_SIDED|95.0|-0.95|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|-0.95|0.469
91745194|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.616|TWO_SIDED|95.0|-0.87|0.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.87|0.616
91745195|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57||||0.002|TWO_SIDED|95.0|0.57|2.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.57|0.002
91745196|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.54||||0.002|TWO_SIDED|95.0|0.55|2.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.53|0.55|0.002
91745197|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.95|||<|0.001|TWO_SIDED|95.0|0.95|2.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.94|0.95|<0.001
91745198|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.91|||<|0.001|TWO_SIDED|95.0|0.92|2.9|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|0.92|<0.001
91745199|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.34||||0.33|TWO_SIDED|95.0|-1.04|0.35|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-1.04|0.330
91745200|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-1.06|0.288
91501328|NCT00056407|182873129|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.3|||<|0.0001||95.0|15.6|30.3||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data given are for the overall assessment.|||30.3|15.6|<0.0001
91501329|NCT00056407|182873130|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.1|||<|0.0001||95.0|15.5|30.0||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data are given are for the overall assessment.|||30.0|15.5|<0.0001
91501330|NCT00056407|182873131|SUPERIORITY_OR_OTHER||Relative Risk Reduction|22.8|||<|0.0001||95.0|15.2|29.8||The p value is given for the overall assessment.|Mantel-Cox||Estimation data are given for the overall assessment.|||29.8|15.2|<0.0001
91501331|NCT00056407|182873154|SUPERIORITY_OR_OTHER||Difference in adjusted means|18.8|||<|0.001||95.0|17.3|20.4|||general linear model, t-test||The adjusted mean difference was calculated as the difference between the adjusted means (-6.1 and 12.7) for the placebo and Dutasteride arms, respectively.|||20.4|17.3|<0.001
91745201|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.916|TWO_SIDED|95.0|-0.66|0.73|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.66|0.916
91745202|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.01||||0.041|TWO_SIDED|95.0|0.04|1.98|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|0.04|0.041
91501332|NCT02335099|182873181|SUPERIORITY||Odds Ratio (OR)|3.77||||0.32|TWO_SIDED|95.0|0.27|217.52|||Fisher Exact|||||217.52|0.27|0.32
91501333|NCT02335099|182873182|SUPERIORITY||Cox Proportional Hazard|0.86||||0.82|TWO_SIDED|95.0|0.23|3.2|||Log Rank|||||3.20|0.23|0.82
91501334|NCT04702997|182873189|SUPERIORITY||LS Mean difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|1.268|<|0.0001|TWO_SIDED|95.0|5.18|10.24||KDIGO strata, treatment group, time (Week 1 to 12), and the interaction between treatment and time were used as fixed factors.|Mixed Models Analysis||Difference is bardoxolone methyl - placebo|||10.24|5.18|<0.0001
91745203|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.034|TWO_SIDED|95.0|0.08|2.01|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.01|0.08|0.034
91745204|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.001|TWO_SIDED|95.0|0.62|2.56|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.62|0.001
91745205|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48||||0.003|TWO_SIDED|95.0|0.52|2.45|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|0.52|0.003
91745206|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.2|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-1.15|0.171
91745207|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.201|TWO_SIDED|95.0|-1.11|0.23|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-1.11|0.201
91745208|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.763|TWO_SIDED|95.0|-0.57|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.57|0.763
91745209|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.66||||0.175|TWO_SIDED|95.0|-0.3|1.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.61|-0.30|0.175
91745210|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.12|TWO_SIDED|95.0|-0.2|1.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|-0.20|0.120
91745211|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.014|TWO_SIDED|95.0|0.24|2.15|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.15|0.24|0.014
91745212|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.007|TWO_SIDED|95.0|0.36|2.26|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|0.36|0.007
91745213|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.054|TWO_SIDED|95.0|-1.32|0.01|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-1.32|0.054
91745214|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.096|TWO_SIDED|95.0|-1.22|0.1|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.10|-1.22|0.096
91745215|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.724|TWO_SIDED|95.0|-0.79|0.55|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.79|0.724
91745216|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.345|TWO_SIDED|95.0|-0.46|1.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.46|0.345
91745217|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.54||||0.228|TWO_SIDED|95.0|-0.34|1.41|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|-0.34|0.228
91745218|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.9||||0.045|TWO_SIDED|95.0|0.02|1.78|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.02|0.045
91745219|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.08||||0.016|TWO_SIDED|95.0|0.21|1.96|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.96|0.21|0.016
91745220|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.036|TWO_SIDED|95.0|-1.27|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-1.27|0.036
91501335|NCT01103284|182873222|SUPERIORITY_OR_OTHER|||||||0.33||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The Mixed-Effect Model Repeated Measure (MMRM) was adjusted for the following baseline covariates: age, C-peptide, insulin dose by body weight and AUC||||||0.33
91745221|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.081|TWO_SIDED|95.0|-1.15|0.07|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.07|-1.15|0.081
91501336|NCT01103284|182873223|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||A priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC.||||||0.68
91501337|NCT01103284|182873224|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC||||||0.44
91745222|NCT01559259|183384896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.43|-0.80|0.556
91745223|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.01|3.05||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.05|2.01|<0.001
91745224|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.75||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.75|1.72|<0.001
91745225|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56|||<|0.001|TWO_SIDED|95.0|2.04|3.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.08|2.04|<0.001
91745226|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.60|1.57|<0.001
91745227|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.44||||0.016|TWO_SIDED|95.0|0.08|0.81||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.81|0.08|0.016
91745228|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.14||||0.428|TWO_SIDED|95.0|-0.21|0.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.50|-0.21|0.428
91745229|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.01|TWO_SIDED|95.0|0.11|0.84||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.84|0.11|0.010
91745230|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.38|||<|0.001|TWO_SIDED|95.0|6.59|10.18||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.18|6.59|<0.001
91745231|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.68|||<|0.001|TWO_SIDED|95.0|5.89|9.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.47|5.89|<0.001
91745232|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.7|||<|0.001|TWO_SIDED|95.0|6.91|10.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.50|6.91|<0.001
91745233|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.65|||<|0.001|TWO_SIDED|95.0|5.86|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.86|<0.001
91745234|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.25|TWO_SIDED|95.0|-0.52|1.99||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.99|-0.52|0.250
91501338|NCT01103284|182873226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.07|TWO_SIDED|95.0|-0.02|0.79||Standard multiple imputation was used to predict the number and timing of hypoglycemic events after discontinuing the study for subjects who did not remain in the study until Month 25.|negative binomial regression|||The number of hypoglycemia events during the study was analyzed using a negative binomial regression model, with number of events as the dependent variable, and treatment, age, baseline daily insulin dose, and baseline C-peptide as covariates. The log of duration in the study for each patient was used as an offset variable in the model.||0.79|-0.02|0.07
91531479|NCT02096081|182939586|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.7|||||TWO_SIDED|95.0|-8.5|3.2|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||3.2|-8.5|
91501339|NCT01190254|182873270|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-4.8||||0.07|TWO_SIDED|95.0|-9.9|0.4||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-9.9|0.070
91501340|NCT01190254|182873270|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.6||||0.064|TWO_SIDED|95.0|-10.7|-0.5||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-10.7|0.064
91501341|NCT01190254|182873270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||||||p-value (adjusted to control Type I error in multiple testing) for Linear dose-response pattern (Placebo\<2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.064
91531480|NCT02096081|182939587|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.8|||||TWO_SIDED|95.0|-11.0|5.3|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||5.3|-11.0|
91745235|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.956|TWO_SIDED|95.0|-1.21|1.28||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.28|-1.21|0.956
91745236|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06||||0.099|TWO_SIDED|95.0|-0.2|2.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.31|-0.20|0.099
91760169|NCT05173012|183412052|SUPERIORITY||Least Squares (LS) Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.5325|TWO_SIDED|95.0|-0.84|1.62|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 15 mg - placebo.|||1.62|-0.84|0.5325
91501342|NCT01190254|182873270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||||||p-value (adjusted to control Type I error in multiple testing) for Convex dose-response pattern (Placebo\<2.5 mg=5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.046
91501343|NCT01190254|182873270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||p-value (adjusted to control Type I error in multiple testing) for Concave dose-response pattern (Placebo=2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.273
91531481|NCT02096081|182939588|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.5|||||TWO_SIDED|95.0|-12.4|9.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.5|-12.4|
91531482|NCT02096081|182939589|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.9|||||TWO_SIDED|95.0|-14.4|10.7|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||10.7|-14.4|
91531483|NCT02886728|182939596|SUPERIORITY||Difference in Response Rates|9.6|||<|0.001|TWO_SIDED|95.0|3.6|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||15.6|3.6|<0.001
91501344|NCT01190254|182873271|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.218|TWO_SIDED|95.0|-0.5|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-0.5|0.218
91513601|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.03|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.03|0.88|< 0.001
91745237|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.22|||<|0.001|TWO_SIDED|95.0|7.78|12.66||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.66|7.78|<0.001
91745238|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.49|||<|0.001|TWO_SIDED|95.0|7.06|11.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||11.92|7.06|<0.001
91745239|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.72|||<|0.001|TWO_SIDED|95.0|8.28|13.15||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||13.15|8.28|<0.001
91745240|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.63|||<|0.001|TWO_SIDED|95.0|7.19|12.06||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.06|7.19|<0.001
91745241|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.6||||0.492|TWO_SIDED|95.0|-1.11|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-1.11|0.492
91745242|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.873|TWO_SIDED|95.0|-1.83|1.56||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.56|-1.83|0.873
91745243|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.09||||0.21|TWO_SIDED|95.0|-0.62|2.79||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.79|-0.62|0.210
91745244|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.65|||<|0.001|TWO_SIDED|95.0|8.1|15.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.20|8.10|<0.001
91745245|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.94|||<|0.001|TWO_SIDED|95.0|7.4|14.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.48|7.40|<0.001
91745246|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.65|||<|0.001|TWO_SIDED|95.0|9.1|16.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.20|9.10|<0.001
91513602|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.66|< 0.001
91501345|NCT01190254|182873271|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.024||95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.0|-0.6|0.024
91501346|NCT01190254|182873272|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.6||||0.067|TWO_SIDED|95.0|-3.3|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-3.3|0.067
91531484|NCT02886728|182939596|SUPERIORITY||Difference in Response Rates|8.8||||0.017|TWO_SIDED|95.0|1.5|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||16.1|1.5|0.017
91745247|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.72|||<|0.001|TWO_SIDED|95.0|8.18|15.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.26|8.18|<0.001
91745248|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.957|TWO_SIDED|95.0|-2.55|2.42||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.42|-2.55|0.957
91745249|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.534|TWO_SIDED|95.0|-3.25|1.69||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.69|-3.25|0.534
91501347|NCT01190254|182873272|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.012|TWO_SIDED|95.0|-3.8|-0.5|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-3.8|0.012
91501348|NCT01190254|182873273|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.097|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.097
91501349|NCT01190254|182873273|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.099|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.099
91531485|NCT02886728|182939596|SUPERIORITY||Difference in Response Rates|6.7||||0.058|TWO_SIDED|95.0|-0.7|14.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||14.1|-0.7|0.058
91745250|NCT01559259|183384897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.93||||0.462|TWO_SIDED|95.0|-1.55|3.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.41|-1.55|0.462
91531486|NCT02886728|182939597|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|-0.27|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.27|<0.001
91745251|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.06|||<|0.001|TWO_SIDED|95.0|7.23|10.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.89|7.23|<0.001
91745252|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.14|||<|0.001|TWO_SIDED|95.0|6.33|9.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.95|6.33|<0.001
91745253|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.66|||<|0.001|TWO_SIDED|95.0|6.83|10.49||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.49|6.83|<0.001
91745254|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.61|||<|0.001|TWO_SIDED|95.0|5.78|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.78|<0.001
91745255|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.45||||0.024|TWO_SIDED|95.0|0.19|2.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.70|0.19|0.024
91745256|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.392|TWO_SIDED|95.0|-0.69|1.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.76|-0.69|0.392
91745257|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.101|TWO_SIDED|95.0|-0.21|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-0.21|0.101
91745258|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.23|||<|0.001|TWO_SIDED|95.0|23.97|36.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.48|23.97|<0.001
91745259|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.93|||<|0.001|TWO_SIDED|95.0|21.74|34.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||34.11|21.74|<0.001
91745260|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.86|||<|0.001|TWO_SIDED|95.0|23.6|36.12||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.12|23.60|<0.001
91745261|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.59|||<|0.001|TWO_SIDED|95.0|21.33|33.86||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||33.86|21.33|<0.001
91745262|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63||||0.228|TWO_SIDED|95.0|-1.65|6.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.92|-1.65|0.228
91745263|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.875|TWO_SIDED|95.0|-3.84|4.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.51|-3.84|0.875
91745264|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.27||||0.299|TWO_SIDED|95.0|-2.02|6.55||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.55|-2.02|0.299
91501350|NCT01190254|182873274|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.7||||0.062|TWO_SIDED|95.0|-5.6|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-5.6|0.062
91745265|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|36.98|||<|0.001|TWO_SIDED|95.0|28.48|45.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.47|28.48|<0.001
91745266|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.1|||<|0.001|TWO_SIDED|95.0|26.7|43.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.50|26.70|<0.001
91745267|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|37.09|||<|0.001|TWO_SIDED|95.0|28.6|45.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.59|28.60|<0.001
91745268|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.17|||<|0.001|TWO_SIDED|95.0|26.67|43.68||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.68|26.67|<0.001
91745269|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.8||||0.543|TWO_SIDED|95.0|-4.02|7.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.63|-4.02|0.543
91745270|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.979|TWO_SIDED|95.0|-5.75|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-5.75|0.979
91745271|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.92||||0.517|TWO_SIDED|95.0|-3.9|7.74||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.74|-3.90|0.517
91745272|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.96|||<|0.001|TWO_SIDED|95.0|30.51|55.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||55.41|30.51|<0.001
91745273|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.2|||<|0.001|TWO_SIDED|95.0|29.9|54.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||54.51|29.90|<0.001
91501351|NCT01190254|182873274|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.2||||0.025|TWO_SIDED|95.0|-6.0|-0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.4|-6.0|0.025
91745274|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|45.12|||<|0.001|TWO_SIDED|95.0|32.67|57.57||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||57.57|32.67|<0.001
91501352|NCT01190254|182873275|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.098|TWO_SIDED|95.0|-4.6|0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-4.6|0.098
91501353|NCT01190254|182873275|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.3||||0.071|TWO_SIDED|95.0|-4.8|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-4.8|0.071
91745275|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|44.25|||<|0.001|TWO_SIDED|95.0|31.79|56.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||56.71|31.79|<0.001
91745276|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.29||||0.767|TWO_SIDED|95.0|-9.82|7.25||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.25|-9.82|0.767
91745277|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.04||||0.629|TWO_SIDED|95.0|-10.36|6.27||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.27|-10.36|0.629
91745278|NCT01559259|183384898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87||||0.841|TWO_SIDED|95.0|-7.66|9.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.39|-7.66|0.841
91745279|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.97|||<|0.001|TWO_SIDED|95.0|3.22|4.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.73|3.22|<0.001
91745280|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.64|||<|0.001|TWO_SIDED|95.0|2.88|4.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.39|2.88|<0.001
91501354|NCT01190254|182873276|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.4||||0.106|TWO_SIDED|95.0|-3.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-3.1|0.106
91501355|NCT01190254|182873276|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-3.6|0.026
91501356|NCT01190254|182873277|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.083|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.083
91501357|NCT01190254|182873277|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.067|TWO_SIDED|95.0|-2.7|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.7|0.067
91501358|NCT01190254|182873278|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.131|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.131
91501359|NCT01190254|182873278|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.135|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.135
91501360|NCT01190254|182873279|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.0||||0.071|TWO_SIDED|95.0|-2.0|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.0|0.071
91501361|NCT01190254|182873279|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.9|0.120
91531487|NCT02886728|182939597|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.009|TWO_SIDED|95.0|-0.23|-0.03||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.03|-0.23|0.009
91531488|NCT02886728|182939597|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.032|TWO_SIDED|95.0|-0.2|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.20|0.032
91531489|NCT02886728|182939598|SUPERIORITY||Difference in Response Rates|25.0|||<|0.001|TWO_SIDED|95.0|18.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||31.7|18.3|<0.001
91531490|NCT02886728|182939598|SUPERIORITY||Difference in Response Rates|13.4|||<|0.001|TWO_SIDED|95.0|5.0|21.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||21.8|5.0|<0.001
91745281|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.07|||<|0.001|TWO_SIDED|95.0|3.32|4.83||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.83|3.32|<0.001
91531491|NCT02886728|182939598|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|5.0|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.6|5.0|<0.001
91745282|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.39|||<|0.001|TWO_SIDED|95.0|2.64|4.14||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.14|2.64|<0.001
91760170|NCT05173012|183412052|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.634||0.6549|TWO_SIDED|95.0|-1.54|0.97|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 30 mg - placebo.|||0.97|-1.54|0.6549
91501362|NCT01190254|182873280|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.4||||0.263|TWO_SIDED|95.0|-1.2|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-1.2|0.263
91501363|NCT01190254|182873280|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.146|TWO_SIDED|95.0|-1.3|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.3|0.146
91501364|NCT01190254|182873281|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.028|TWO_SIDED|95.0|1.1|3.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.6|1.1|0.028
91745283|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.58||||0.031|TWO_SIDED|95.0|0.05|1.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.11|0.05|0.031
91745284|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.36|TWO_SIDED|95.0|-0.28|0.77||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.77|-0.28|0.360
91745285|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.68||||0.011|TWO_SIDED|95.0|0.15|1.21||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.21|0.15|0.011
91745286|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.14|||<|0.001|TWO_SIDED|95.0|10.54|15.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.73|10.54|<0.001
91745287|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.94|||<|0.001|TWO_SIDED|95.0|9.35|14.52||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.52|9.35|<0.001
91745288|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.54|||<|0.001|TWO_SIDED|95.0|10.95|16.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.13|10.95|<0.001
91745289|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.04|||<|0.001|TWO_SIDED|95.0|9.45|14.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.63|9.45|<0.001
91745290|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.1||||0.235|TWO_SIDED|95.0|-0.72|2.91||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.91|-0.72|0.235
91745291|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.91|TWO_SIDED|95.0|-1.91|1.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.70|-1.91|0.910
91745292|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5||||0.105|TWO_SIDED|95.0|-0.32|3.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.31|-0.32|0.105
91745293|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.05|||<|0.001|TWO_SIDED|95.0|12.49|19.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||19.61|12.49|<0.001
91745294|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|14.88|||<|0.001|TWO_SIDED|95.0|11.33|18.43||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.43|11.33|<0.001
91745295|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.76|||<|0.001|TWO_SIDED|95.0|13.2|20.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||20.32|13.20|<0.001
91745296|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|15.23|||<|0.001|TWO_SIDED|95.0|11.68|18.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.78|11.68|<0.001
91745297|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.514|TWO_SIDED|95.0|-1.66|3.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.32|-1.66|0.514
91745298|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.783|TWO_SIDED|95.0|-2.82|2.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.13|-2.82|0.783
91745299|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.227|TWO_SIDED|95.0|-0.96|4.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.02|-0.96|0.227
91745300|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.28|||<|0.001|TWO_SIDED|95.0|12.95|23.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.61|12.95|<0.001
91745301|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|17.3|||<|0.001|TWO_SIDED|95.0|11.99|22.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||22.61|11.99|<0.001
91745302|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|20.45|||<|0.001|TWO_SIDED|95.0|15.13|25.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.78|15.13|<0.001
91745303|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.92|||<|0.001|TWO_SIDED|95.0|13.61|24.24||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.24|13.61|<0.001
91745304|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.64||||0.736|TWO_SIDED|95.0|-4.37|3.09||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.09|-4.37|0.736
91745305|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62||||0.39|TWO_SIDED|95.0|-5.32|2.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.08|-5.32|0.390
91745306|NCT01559259|183384899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.42|TWO_SIDED|95.0|-2.19|5.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.26|-2.19|0.420
91745307|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.5|||<|0.001|TWO_SIDED|95.0|5.25|7.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.76|5.25|<0.001
91745308|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.87|||<|0.001|TWO_SIDED|95.0|4.62|7.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.11|4.62|<0.001
91531492|NCT02886728|182939599|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.161||0.068|TWO_SIDED|95.0|-0.61|0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.02|-0.61|0.068
91531493|NCT02886728|182939599|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.195||0.14|TWO_SIDED|95.0|-0.67|0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.10|-0.67|0.14
91501365|NCT01190254|182873281|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.048|TWO_SIDED|95.0|1.0|3.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.3|1.0|0.048
91501366|NCT01190254|182873282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||||||p-value is for Log Rank test of difference in time to event (PANSS 30% response) curves between the three treatment groups|Log Rank|||||||0.576
91501367|NCT01190254|182873282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.171|TWO_SIDED|95.0|0.9|2.0|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||2.0|0.9|0.171
91531494|NCT02886728|182939599|SUPERIORITY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.199||0.006|TWO_SIDED|95.0|-0.94|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-0.94|0.006
91745309|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|6.63|||<|0.001|TWO_SIDED|95.0|5.38|7.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.88|5.38|<0.001
91745310|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.48|||<|0.001|TWO_SIDED|95.0|4.23|6.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.73|4.23|<0.001
91745311|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03||||0.022|TWO_SIDED|95.0|0.15|1.9||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.90|0.15|0.022
91745312|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.38|TWO_SIDED|95.0|-0.48|1.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.26|-0.48|0.380
91745313|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15||||0.01|TWO_SIDED|95.0|0.28|2.03||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.03|0.28|0.010
91745314|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|21.52|||<|0.001|TWO_SIDED|95.0|17.17|25.87||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.87|17.17|<0.001
91501368|NCT01190254|182873282|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.368|TWO_SIDED|95.0|0.8|1.8|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||1.8|0.8|0.368
91501369|NCT01190254|182873283|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.094|TWO_SIDED|95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.0|-0.6|0.094
91501370|NCT01190254|182873283|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.003|TWO_SIDED|95.0|-0.8|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-0.8|0.003
91501371|NCT01190254|182873284|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.177|TWO_SIDED|95.0|0.8|2.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.8|0.8|0.177
91501372|NCT01190254|182873284|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.114|TWO_SIDED|95.0|0.9|2.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.9|0.9|0.114
91501373|NCT01190254|182873285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||p-value is for Log Rank test of difference in time to event (CGI-I response) curves between the three treatment groups|Log Rank|||||||0.057
91745315|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.62|||<|0.001|TWO_SIDED|95.0|15.29|23.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.95|15.29|<0.001
91745316|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|22.24|||<|0.001|TWO_SIDED|95.0|17.89|26.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||26.59|17.89|<0.001
91745317|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.69|||<|0.001|TWO_SIDED|95.0|15.35|24.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.02|15.35|<0.001
91745318|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.83||||0.237|TWO_SIDED|95.0|-1.21|4.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.88|-1.21|0.237
91745319|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.965|TWO_SIDED|95.0|-3.09|2.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.95|-3.09|0.965
91745320|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56||||0.099|TWO_SIDED|95.0|-0.48|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-0.48|0.099
91745321|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.93|||<|0.001|TWO_SIDED|95.0|21.14|38.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||38.73|21.14|<0.001
91745322|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|28.24|||<|0.001|TWO_SIDED|95.0|19.48|37.0||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||37.00|19.48|<0.001
91745323|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|33.1|||<|0.001|TWO_SIDED|95.0|24.31|41.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||41.89|24.31|<0.001
91745324|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.64|||<|0.001|TWO_SIDED|95.0|21.87|39.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||39.41|21.87|<0.001
91760171|NCT05173012|183412052|SUPERIORITY||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.7||0.1462|TWO_SIDED|95.0|-0.36|2.41|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 60 mg - placebo.|||2.41|-0.36|0.1462
91501374|NCT01190254|182873285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.3|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.3|0.9|0.135
91501375|NCT01190254|182873285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8||||0.01|TWO_SIDED|95.0|1.2|2.9|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.9|1.2|0.010
91501376|NCT01190254|182873286|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.4||||0.417|TWO_SIDED|95.0|-2.0|4.8|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||4.8|-2.0|0.417
91501377|NCT01190254|182873286|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.2||||0.017|TWO_SIDED|95.0|0.8|7.6|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||7.6|0.8|0.017
91501378|NCT01190254|182873287|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||2.8|-1.6|0.600
91501379|NCT01190254|182873287|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.1||||0.064|TWO_SIDED|95.0|-0.1|4.3|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||4.3|-0.1|0.064
91501380|NCT01190254|182873288|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.407|TWO_SIDED|95.0|-0.13|0.33|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.33|-0.13|0.407
91501381|NCT01190254|182873288|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.19||||0.111|TWO_SIDED|95.0|-0.04|0.42|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.42|-0.04|0.111
91745325|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.71||||0.821|TWO_SIDED|95.0|-6.86|5.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.44|-6.86|0.821
91745326|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.4||||0.44|TWO_SIDED|95.0|-8.51|3.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.71|-8.51|0.440
91745327|NCT01559259|183384900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46||||0.432|TWO_SIDED|95.0|-3.69|8.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||8.61|-3.69|0.432
91745328|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.08||||0.571|TWO_SIDED|95.0|-1.04|3.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.20|-1.04|0.571
91501382|NCT00202644|182873298|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-100.5|STANDARD_ERROR_OF_MEAN|39.93|||TWO_SIDED|95.0|-179.42|-21.49||||||||-21.49|-179.42|
91501383|NCT00202644|182873299|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-113.1|STANDARD_ERROR_OF_MEAN|37.56|||TWO_SIDED|95.0|-187.4|-38.83||||||Month 3||-38.83|-187.40|
91501384|NCT00202644|182873299|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-68.3|STANDARD_ERROR_OF_MEAN|43.83|||TWO_SIDED|95.0|-154.95|18.43||||||Month 36||18.43|-154.95|
91501385|NCT03232281|182873316|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was confirmed.|Rate difference (%)|-0.7|||||TWO_SIDED|95.0|-4.41|2.58|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||2.58|-4.41|
91501386|NCT03232281|182873317|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
91501387|NCT03232281|182873317|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-6.8|-0.16|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.16|-6.80|
91501388|NCT03232281|182873318|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
91745329|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.98||||0.593|TWO_SIDED|95.0|-0.94|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-0.94|0.593
91745330|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.65||||0.282|TWO_SIDED|95.0|-0.39|7.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.68|-0.39|0.282
91501389|NCT03232281|182873318|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-4.1|||||TWO_SIDED|95.0|-8.93|-0.52|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.52|-8.93|
91745331|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.16||||0.552|TWO_SIDED|95.0|-1.11|3.42||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.42|-1.11|0.552
91745332|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.01||||0.994|TWO_SIDED|95.0|-3.13|3.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.11|-3.13|0.994
91745333|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.23||||0.879|TWO_SIDED|95.0|-3.26|2.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.80|-3.26|0.879
91745334|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.33||||0.28|TWO_SIDED|95.0|-1.98|6.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.64|-1.98|0.280
91745335|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|33.67|||<|0.001|TWO_SIDED|95.0|24.54|42.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.81|24.54|<0.001
91513603|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.52|||=|0.167|TWO_SIDED|95.0|0.48|0.58|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.58|0.48|= 0.167
91513604|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.71|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.71|< 0.001
91513605|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.71|< 0.001
91501390|NCT03232281|182873318|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-7.44|1.17|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 12. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.17|-7.44|
91531495|NCT02886728|182939600|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.8|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.8|<0.001
91745336|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.34||||0.003|TWO_SIDED|95.0|14.93|31.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.75|14.93|0.003
91745337|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|22.28||||0.005|TWO_SIDED|95.0|13.55|31.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.00|13.55|0.005
91745338|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.39||||0.035|TWO_SIDED|95.0|6.28|20.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.50|6.28|0.035
91745339|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|20.14||||0.001|TWO_SIDED|95.0|8.67|31.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.62|8.67|0.001
91745340|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.56||||0.088|TWO_SIDED|95.0|-1.39|20.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.51|-1.39|0.088
91745341|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.36||||0.1|TWO_SIDED|95.0|-1.73|20.45||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.45|-1.73|0.100
91760172|NCT05173012|183412053|SUPERIORITY||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|1.326||0.1271|TWO_SIDED|95.0|0.59|4.67|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||4.67|0.59|0.1271
91501391|NCT00861146|182873325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Chi-squared|df = 1||||||<.01
91501392|NCT00861146|182873326|SUPERIORITY_OR_OTHER_LEGACY||mixed model regression analyses (F)|2.04|||>|0.15|||||||mixed model regression analyses|||Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).||||> .15
91531496|NCT02886728|182939600|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.69||0.021|TWO_SIDED|95.0|0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.2|0.021
91501393|NCT00861146|182873327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|df=1||||||<.001
91501394|NCT02024867|182873356|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.|Rate Difference|4.0||||0.25|TWO_SIDED|95.0|-1.5|9.5|||Chi-squared|||||9.5|-1.5|0.25
91501395|NCT02024867|182873357|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.7||||0.02|TWO_SIDED|95.0|2.1|19.2|||Chi-squared|||||19.2|2.1|0.02
91501396|NCT02024867|182873358|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.1||||0.03|TWO_SIDED|95.0|2.1|18.2|||Chi-squared|||||18.2|2.1|0.03
91501397|NCT02024867|182873359|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|0.1|||>|0.05|TWO_SIDED|95.0|-6.9|7.0|||Chi-squared|||||7.0|-6.9|>0.05
91501398|NCT02024867|182873360|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.3||||0.046|TWO_SIDED|95.0|0.8|19.9|||Chi-squared|||||19.9|0.8|0.046
91501399|NCT02024867|182873361|NON_INFERIORITY_OR_EQUIVALENCE|described previously|rate difference|0.0|||>|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||>0.05
91501400|NCT02278263|182873397|SUPERIORITY||||||<|0.05|||||||ANOVA|||Assuming a common standard deviation of 412 mL, to detect a difference of 300 mL of blood loss between the two treatment arms (sTXA and tTXA) and the placebo group, a sample size of 125 participants is required for a statistical power of 0.85, and a type I error of 0.05. The sample size required was 125 participants in total. The was increased by 15% to allow for expected dropouts. Therefore, a minimum of 147 patients was required for the study.||||<0.05
91501401|NCT00527943|182873457|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.072|TWO_SIDED|95.0|0.85|1.01|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.01|0.85|0.072
91501402|NCT00527943|182873458|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.018|TWO_SIDED|95.0|0.81|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.81|0.018
91501403|NCT00527943|182873459|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.36|||<|0.001|TWO_SIDED|95.0|1.18|1.57|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.57|1.18|<0.001
91501404|NCT00527943|182873460|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.29|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.29|<0.001
91501405|NCT00527943|182873461|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.038|TWO_SIDED|95.0|0.84|1.0|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.00|0.84|0.038
91501406|NCT00527943|182873462|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.027|TWO_SIDED|95.0|0.81|0.99|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.99|0.81|0.027
91501407|NCT00527943|182873463|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.174|TWO_SIDED|95.0|0.87|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.87|0.174
91531497|NCT02886728|182939600|SUPERIORITY||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.69||0.24|TWO_SIDED|95.0|-0.5|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.5|0.24
91745342|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|62.54|||<|0.001|TWO_SIDED|95.0|50.93|74.15||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.15|50.93|<0.001
91745343|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|51.66|||<|0.001|TWO_SIDED|95.0|39.5|63.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.82|39.50|<0.001
91501408|NCT00527943|182873464|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.108|TWO_SIDED|95.0|0.86|1.02|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.02|0.86|0.108
91501409|NCT00527943|182873465|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.963|TWO_SIDED|95.0|0.83|1.22|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.22|0.83|0.963
91501410|NCT00527943|182873466|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.021|TWO_SIDED|95.0|0.79|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.79|0.021
91501411|NCT00527943|182873467|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.418|TWO_SIDED|95.0|0.83|1.58|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.58|0.83|0.418
91501412|NCT00527943|182873468|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.07||||0.493|TWO_SIDED|95.0|0.88|1.31|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.31|0.88|0.493
91501413|NCT00527943|182873469|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05||||0.515|TWO_SIDED|95.0|0.9|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.90|0.515
91501414|NCT00527943|182873470|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.606|TWO_SIDED|95.0|0.7|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.70|0.606
91501415|NCT00137423|182873485|SUPERIORITY_OR_OTHER||Objective Response Rate|28.3||||||95.0|16.8|42.3|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||42.3|16.8|
91501416|NCT00137423|182873485|SUPERIORITY_OR_OTHER||Objective Response Rate|11.5||||||95.0|4.4|23.4|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||23.4|4.4|
91501417|NCT00137423|182873489|SUPERIORITY_OR_OTHER||1-year survival rate|77.4||||||95.0|63.6|86.5|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||86.5|63.6|
91531498|NCT02886728|182939601|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.68||0.056|TWO_SIDED|95.0|0.0|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.0|0.056
91531499|NCT02886728|182939601|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.82||0.1|TWO_SIDED|95.0|-0.3|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-0.3|0.10
91531500|NCT02886728|182939601|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.67|TWO_SIDED|95.0|-1.3|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-1.3|0.67
91531501|NCT02886728|182939602|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.195|<|0.001|TWO_SIDED|95.0|-1.03|-0.27||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.27|-1.03|<0.001
91745344|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.68|||<|0.001|TWO_SIDED|95.0|52.92|76.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.43|52.92|<0.001
91745345|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|52.03|||<|0.001|TWO_SIDED|95.0|40.43|63.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.63|40.43|<0.001
91501418|NCT00137423|182873489|SUPERIORITY_OR_OTHER||1-year survival rate|66.0||||||95.0|51.6|77.1|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||77.1|51.6|
91531502|NCT02886728|182939602|SUPERIORITY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.236||0.008|TWO_SIDED|95.0|-1.09|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-1.09|0.008
91501419|NCT04339296|182873513|EQUIVALENCE|An independent sample t-test was performed between intervention and control group to determine if the difference of the mean medication adherence is equal to zero (null hypothesis).|Mean Difference (Net)|7.18|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Medication Adherence Difference = Intervention Adherence - Control Adherence|||||<0.01
91501420|NCT04339296|182873514|EQUIVALENCE|The null hypothesis assumes that the true mean difference for intervention participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.5|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Mean difference (intervention participants self-reported score) = baseline minus 6-month.|||||<0.01
91501421|NCT04339296|182873514|EQUIVALENCE|The null hypothesis assumes that the true mean difference for control participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.07||||0.07|TWO_SIDED|||||Statistical tests was set at 95% confidence level.|t-test, 2 sided||Mean difference (control participants self-reported score) = baseline minus 6-month.|||||0.07
91501422|NCT00969150|182873531|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.49||||0.2492|TWO_SIDED|95.0|-4.02|1.05|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.05|-4.02|0.2492
91501423|NCT00969150|182873532|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.54||||0.5625|TWO_SIDED|95.0|-2.38|1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.29|-2.38|0.5625
91501424|NCT01765153|182873566|SUPERIORITY_OR_OTHER|||||||0.04366667|||||||t-test, 2 sided|||||||0.04366667
91501425|NCT00353262|182873747|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.79|1.02||||||Cycle 2, Day 1 versus Cycle 1, Day 1||1.02|0.79|
91501426|NCT00353262|182873747|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.76|0.99||||||Cycle 3, Day 1 versus Cycle 1, Day 1||0.99|0.76|
91501427|NCT00353262|182873747|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.85|1.1||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.10|0.85|
91501428|NCT00353262|182873748|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.01|1.08||||||Cycle 2, Day 1 versus Cycle 1, Day 2||1.08|1.01|
91501429|NCT00353262|182873748|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05||||||Cycle 3, Day 1 to Cycle 1, Day 2||1.05|0.98|
91501430|NCT00353262|182873748|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.00|0.94|
91501431|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.83|1.24||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.24|0.83|
91501432|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|90.0|0.94|1.42||||||Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1||1.42|0.94|
91501433|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.96|1.44||||||Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1||1.44|0.96|
91501434|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.69|1.08||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.69|
91501435|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.86|1.34||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.34|0.86|
91531503|NCT02886728|182939602|SUPERIORITY||Least Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.242||0.006|TWO_SIDED|95.0|-1.14|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-1.14|0.006
91760173|NCT05173012|183412053|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.347||0.5642|TWO_SIDED|95.0|-3.45|1.89|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||1.89|-3.45|0.5642
91501436|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|90.0|1.0|1.55||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.55|1.00|
91501437|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.66|1.01||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||1.01|0.66|
91501438|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|90.0|0.64|0.97||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.97|0.64|
91501439|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.78|1.19||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.19|0.78|
91501440|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.04|0.91|
91501441|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||1.04|0.90|
91501442|NCT00353262|182873749|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.93|
91501443|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.61|0.9||||||5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1||0.90|0.61|
91501444|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.64|||||TWO_SIDED|90.0|0.53|0.79||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1||0.79|0.53|
91501445|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.71|1.06||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.06|0.71|
91501446|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.63|1.08||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.63|
91501447|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03|||||TWO_SIDED|90.0|0.78|1.34||||||Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1||1.34|0.78|
91501448|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.65|1.1||||||Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1||1.10|0.65|
91501449|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.65|1.18||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.18|0.65|
91501450|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.71|1.3||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.30|0.71|
91501451|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.81|1.49||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.49|0.81|
91501452|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.56|0.98||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||0.98|0.56|
91501453|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.58|||||TWO_SIDED|90.0|0.44|0.76||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.76|0.44|
91501454|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.78|||||TWO_SIDED|90.0|0.59|1.03||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.03|0.59|
91501455|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.00|0.83|
91501456|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.76|0.91||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||0.91|0.76|
91501457|NCT00353262|182873751|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.00|0.83|
91501458|NCT00353262|182873753|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|1.09|1.33||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.33|1.09|
91501459|NCT00353262|182873753|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|90.0|1.21|1.48||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.48|1.21|
91501460|NCT00353262|182873753|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.01|1.23||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.23|1.01|
91501461|NCT00353262|182873755|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.96|
91501462|NCT00353262|182873755|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.95|
91531504|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|25.5|||<|0.001|TWO_SIDED|95.0|19.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||31.7|19.3|<0.001
91760174|NCT05173012|183412053|SUPERIORITY||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|1.439||0.486|TWO_SIDED|95.0|-1.84|3.85|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||3.85|-1.84|0.4860
91501463|NCT00353262|182873755|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.05|0.93|
91501464|NCT00353262|182873755|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.94|
91501465|NCT00353262|182873755|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.92|
91501466|NCT00353262|182873755|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.07||||||Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.91|
91501467|NCT01304966|182873904|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 1 sided|||||||0.013
91501468|NCT04105998|182873905|SUPERIORITY|Exploratory analysis without power calculation||||||0.64|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.64
91501469|NCT04105998|182873906|SUPERIORITY|Exploratory analysis without power calculation||||||0.19|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.19
91531505|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|20.6|||<|0.001|TWO_SIDED|95.0|12.8|28.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||28.5|12.8|<0.001
91501470|NCT04105998|182873907|SUPERIORITY|Exploratory analysis without power calculation||||||0.067|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.067
91501471|NCT04105998|182873908|SUPERIORITY|Exploratory analysis without power calculation||||||0.25|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.25
91501472|NCT04105998|182873909|SUPERIORITY|Exploratory analysis without power calculation||||||0.058|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.058
91501473|NCT04105998|182873910|SUPERIORITY|Exploratory analysis without power calculation||||||0.111|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.111
91501474|NCT02073279|182873968|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0184|TWO_SIDED|95.0|0.23|0.89|||Log Rank|||Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).||0.89|0.23|0.0184
91501475|NCT02073279|182873969|SUPERIORITY||Mean Difference (Final Values)|3.215|STANDARD_ERROR_OF_MEAN|4.178||0.4436||95.0|-5.086|11.515|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||11.515|-5.086|0.4436
91501476|NCT02073279|182873970|SUPERIORITY||Mean Difference (Final Values)|2.107|STANDARD_ERROR_OF_MEAN|1.567||0.1824||95.0|-1.008|5.221|||ANCOVA|ANCOVA model included treatment group as fixed effect. Baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||5.221|-1.008|0.1824
91501477|NCT01857232|182874077|SUPERIORITY|||||||0.004|||||||Regression, Logistic|||||||0.004
91501478|NCT01857232|182874077|SUPERIORITY|||||||0.0987|||||||Regression, Logistic|||||||0.0987
91501479|NCT01857232|182874077|SUPERIORITY|||||||0.1041|||||||Regression, Logistic|||||||0.1041
91501480|NCT01857232|182874078|SUPERIORITY|||||||0.0235|||||||Chi-squared, Corrected|1-sided||||||0.0235
91501481|NCT01857232|182874078|SUPERIORITY|||||||0.1651|||||||Chi-squared, Corrected|1-sided||||||0.1651
91501482|NCT01857232|182874078|SUPERIORITY|||||||0.1332|||||||Chi-squared, Corrected|1-sided||||||0.1332
91501483|NCT04501666|182874092|SUPERIORITY||Strata adjusted percentage difference|40.1|||<|0.0001|TWO_SIDED|95.0|29.4|50.8||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||50.8|29.4|< 0.0001
91501484|NCT04501666|182874093|SUPERIORITY||Strata adjusted percentage difference|14.6||||0.0025|TWO_SIDED|95.0|6.7|22.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.6|6.7|0.0025
91501485|NCT04501666|182874095|SUPERIORITY||Strata adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.0|40.4||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||40.4|23.0|< 0.0001
91501486|NCT04501666|182874096|SUPERIORITY||Strata adjusted percentage difference|30.5|||<|0.0001|TWO_SIDED|95.0|22.3|38.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.7|22.3|< 0.0001
91501487|NCT04501666|182874097|SUPERIORITY||Strata adjusted percentage difference|38.0|||<|0.0001|TWO_SIDED|95.0|27.8|48.2||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.2|27.8|< 0.0001
91501488|NCT04501666|182874098|SUPERIORITY||Strata adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.7|30.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||30.7|14.7|< 0.0001
91745346|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.66||||0.138|TWO_SIDED|95.0|-3.04|24.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.35|-3.04|0.138
91745347|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.59||||0.935|TWO_SIDED|95.0|-14.71|13.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.52|-14.71|0.935
91745348|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.3||||0.063|TWO_SIDED|95.0|-0.57|27.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.17|-0.57|0.063
91745349|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.68|||<|0.001|TWO_SIDED|95.0|62.82|86.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.53|62.82|<0.001
91745350|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.18|||<|0.001|TWO_SIDED|95.0|50.42|75.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.95|50.42|<0.001
91501489|NCT04501666|182874099|SUPERIORITY||Strata adjusted percentage difference|18.7|||<|0.0001|TWO_SIDED|95.0|12.3|25.0||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.0|12.3|< 0.0001
91745351|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.39|||<|0.001|TWO_SIDED|95.0|59.21|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|59.21|<0.001
91760175|NCT03668613|183412054|SUPERIORITY||Predicted Log-OR|4.862|||||TWO_SIDED|95.0|3.422|6.782|||Bayesian method using (MAP)|||Compared to historical placebo||6.782|3.422|
91501490|NCT00894322|182874137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.269||0.0013|TWO_SIDED|95.0|-1.5|-0.4||Treatment group and HbA1c stratum at screening were factors. Placebo was reference group.|ANOVA|||||-0.40|-1.50|0.0013
91501491|NCT00894322|182874138|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Cochran-Mantel-Haenszel|Adjusted for HbA1c strata at screening.||||||0.0033
91760176|NCT03668613|183412054|SUPERIORITY||Predicted log-OR|4.836|||||TWO_SIDED|95.0|3.422|6.772|||Bayesian method using (MAP)|||Compared to historical placebo||6.772|3.422|
91760177|NCT03668613|183412055|SUPERIORITY||Predicted log -OR|4.292|||||TWO_SIDED|95.0|2.638|6.513|||Bayesian method using (MAP)|||Compared to historical placebo||6.513|2.638|
91760178|NCT03668613|183412055|SUPERIORITY||Predicted log-OR|4.606|||||TWO_SIDED|95.0|2.919|6.78|||Bayesian method using (MAP)|||Compared to historical placebo||6.780|2.919|
91760179|NCT03668613|183412056|SUPERIORITY||Predicted log-OR|4.367|||||TWO_SIDED|95.0|2.916|6.202|||Bayesian method using (MAP)|||||6.202|2.916|
91501492|NCT00894322|182874139|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.835||0.2285|TWO_SIDED|95.0|-2.73|0.68|||ANOVA|treatment group and HbA1c stratum at screening were factors.||Least square mean (LS) mean, 95% confidence interval (CI) and p-value calculated for the changes in weight from baseline in participants in cohort 2 treated with exenatide with placebo as reference group.||0.68|-2.73|0.2285
91501493|NCT00894322|182874140|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|12.8||0.0035|TWO_SIDED|95.0|-66.5|-14.3|||ANOVA|treatment group and HbA1c stratum at screening were factors.||||-14.3|-66.5|0.0035
91501494|NCT03338855|182874145|SUPERIORITY||Least Square (LS) Mean Difference|-1.068|STANDARD_ERROR_OF_MEAN|1.014||0.3047|TWO_SIDED|95.0|-3.183|1.047|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RD (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||1.047|-3.183|0.3047
91501495|NCT03338855|182874146|SUPERIORITY||LS Mean Difference|-1.705|STANDARD_ERROR_OF_MEAN|0.517||0.0036|TWO_SIDED|95.0|-2.784|-0.625|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs low insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.625|-2.784|0.0036
91501496|NCT03338855|182874146|SUPERIORITY||LS Mean Difference|-2.292|STANDARD_ERROR_OF_MEAN|0.409|<|0.0001|TWO_SIDED|95.0|-3.146|-1.438|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-1.438|-3.146|<0.0001
91501497|NCT03338855|182874147|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.009||0.1842|TWO_SIDED|95.0|-0.006|0.03|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RER (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.030|-0.006|0.1842
91501498|NCT03338855|182874148|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.005||0.0001|TWO_SIDED|95.0|-0.033|-0.013|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of 24-hour RER between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.013|-0.033|0.0001
91745352|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|60.5|||<|0.001|TWO_SIDED|95.0|47.89|73.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.11|47.89|<0.001
91745353|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.43||||0.027|TWO_SIDED|95.0|1.97|26.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.89|1.97|0.027
91745354|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.35||||0.729|TWO_SIDED|95.0|-10.91|15.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.61|-10.91|0.729
91501499|NCT03338855|182874149|SUPERIORITY||LS Mean Difference|-0.109|STANDARD_ERROR_OF_MEAN|0.065||0.1095|TWO_SIDED|95.0|-0.245|0.027|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of energy expenditure between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.027|-0.245|0.1095
91501500|NCT03338855|182874150|SUPERIORITY||LS Mean Difference|-246.7|STANDARD_ERROR_OF_MEAN|464.3||0.6005|TWO_SIDED|95.0|-1209.5|716.2|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of fat mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||716.2|-1209.5|0.6005
91501501|NCT03338855|182874150|SUPERIORITY||LS Mean Difference|-666.5|STANDARD_ERROR_OF_MEAN|301.1||0.0376|TWO_SIDED|95.0|-1291.0|-41.9|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of lean mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-41.9|-1291.0|0.0376
91501502|NCT03338855|182874151|SUPERIORITY||LS Mean Difference|-1.256|STANDARD_ERROR_OF_MEAN|0.289||0.0003|TWO_SIDED|95.0|-1.854|-0.657|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of total mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.657|-1.854|0.0003
91531506|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|22.9|||<|0.001|TWO_SIDED|95.0|15.1|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||30.8|15.1|<0.001
91531507|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||35.6|22.1|<0.001
91760180|NCT03668613|183412056|SUPERIORITY||Predicted log-OR|4.709|||||TWO_SIDED|95.0|3.201|6.58|||Bayesian method using (MAP)|||||6.580|3.201|
91501503|NCT03338855|182874152|SUPERIORITY||LS Mean Difference|-244.301|STANDARD_ERROR_OF_MEAN|165.168||0.1555|TWO_SIDED|95.0|-590.002|101.401|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of FGF21 AUC between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||101.401|-590.002|0.1555
91501504|NCT00399360|182874183|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
91501505|NCT00399360|182874184|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
91501506|NCT00399360|182874185|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
91501507|NCT00399360|182874186|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
91501508|NCT00399360|182874187|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
91501509|NCT00399360|182874188|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
91501510|NCT00399360|182874189|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
91501511|NCT00399360|182874190|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
91501512|NCT00399360|182874191|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
91501513|NCT00399360|182874192|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
91501514|NCT03143569|182874199|OTHER|||||||0.45|||||||Fisher Exact|||||||.45
91501515|NCT03143569|182874200|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91501516|NCT03143569|182874201|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91501517|NCT03143569|182874202|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91501518|NCT03143569|182874203|OTHER|||||||0.018|||||||Chi-squared|||||||.018
91501519|NCT02472795|182874208|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.39|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||||0.22|-0.56|0.39
91501520|NCT02472795|182874208|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED|95.0|-0.91|0.09|||ANCOVA|||||0.09|-0.91|0.02
91501521|NCT02472795|182874208|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.95|-0.19|||ANCOVA|||||-0.19|-0.95|0.004
91501522|NCT02472795|182874208|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.19||0.06|TWO_SIDED|95.0|-0.75|0.02|||ANCOVA|||||0.02|-0.75|0.06
91501523|NCT02472795|182874210|SUPERIORITY||Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.134||0.2837|TWO_SIDED|95.0|-0.413|0.123|||ANCOVA|||||0.123|-0.413|0.2837
91501524|NCT02472795|182874210|SUPERIORITY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.797|-0.234|||ANCOVA|||||-0.234|-0.797|0.0006
91501525|NCT02472795|182874210|SUPERIORITY||Mean Difference (Final Values)|-0.565|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.825|-0.305|||ANCOVA|||||-0.305|-0.825|0.0001
91745355|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.33||||0.087|TWO_SIDED|95.0|-1.55|24.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.21|-1.55|0.087
91745356|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|75.6|||<|0.001|TWO_SIDED|95.0|62.5|88.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.70|62.50|<0.001
91745357|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.45|||<|0.001|TWO_SIDED|95.0|53.65|81.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.24|53.65|<0.001
91745358|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.46|||<|0.001|TWO_SIDED|95.0|61.21|87.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.70|61.21|<0.001
91745359|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.23|||<|0.001|TWO_SIDED|95.0|50.3|78.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.17|50.30|<0.001
91745360|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.59||||0.052|TWO_SIDED|95.0|0.12|23.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.06|0.12|0.052
91745361|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.652|TWO_SIDED|95.0|-9.49|15.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.16|-9.49|0.652
91745362|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.09|TWO_SIDED|95.0|-1.47|22.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.03|-1.47|0.090
91745363|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|79.93|||<|0.001|TWO_SIDED|95.0|67.41|92.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||92.46|67.41|<0.001
91745364|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|58.25|85.05||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.05|58.25|<0.001
91745365|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|78.92|||<|0.001|TWO_SIDED|95.0|66.29|91.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.56|66.29|<0.001
91745366|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.56|||<|0.001|TWO_SIDED|95.0|57.04|84.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.07|57.04|<0.001
91745367|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.61||||0.069|TWO_SIDED|95.0|-0.59|19.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.80|-0.59|0.069
91745368|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.65||||0.911|TWO_SIDED|95.0|-10.73|12.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.03|-10.73|0.911
91531508|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|22.1|||<|0.001|TWO_SIDED|95.0|13.6|30.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||30.7|13.6|<0.001
91745369|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.27||||0.127|TWO_SIDED|95.0|-2.23|18.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|-2.23|0.127
91745370|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.55|||<|0.001|TWO_SIDED|95.0|62.37|90.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.72|62.37|<0.001
91745371|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.6|||<|0.001|TWO_SIDED|95.0|55.93|85.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.28|55.93|<0.001
91745372|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
91745373|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|53.02|83.09||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.09|53.02|<0.001
91745374|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.57||||0.098|TWO_SIDED|95.0|-1.47|18.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.61|-1.47|0.098
91745375|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.721|TWO_SIDED|95.0|-9.02|13.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.04|-9.02|0.721
91745376|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.28||||0.115|TWO_SIDED|95.0|-1.85|18.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.41|-1.85|0.115
91745377|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|77.66|||<|0.001|TWO_SIDED|95.0|63.63|91.69||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.69|63.63|<0.001
91745378|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|57.07|86.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.22|57.07|<0.001
91745379|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
91745380|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.1|||<|0.001|TWO_SIDED|95.0|54.14|84.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.06|54.14|<0.001
91745381|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.56||||0.086|TWO_SIDED|95.0|-1.15|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-1.15|0.086
91745382|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.714|TWO_SIDED|95.0|-8.76|12.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.77|-8.76|0.714
91745383|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.21||||0.164|TWO_SIDED|95.0|-2.8|17.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.22|-2.80|0.164
91745384|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
91745385|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.5|||<|0.001|TWO_SIDED|95.0|54.29|84.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.70|54.29|<0.001
91745386|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
91745387|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.0|||<|0.001|TWO_SIDED|95.0|51.4|82.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.61|51.40|<0.001
91745388|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.46||||0.129|TWO_SIDED|95.0|-2.12|17.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.04|-2.12|0.129
91745389|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.712|TWO_SIDED|95.0|-8.5|12.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.43|-8.50|0.712
91745390|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.12||||0.229|TWO_SIDED|95.0|-3.76|16.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.00|-3.76|0.229
91745391|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
91745392|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.54|||<|0.001|TWO_SIDED|95.0|55.45|85.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.64|55.45|<0.001
91501526|NCT02472795|182874210|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-1.173|-0.586|||ANCOVA|||||-0.586|-1.173|<0.0001
91501527|NCT02472795|182874212|SUPERIORITY||Mean Difference (Final Values)|-13.214|STANDARD_ERROR_OF_MEAN|9.626||0.1755|TWO_SIDED|95.0|-32.513|6.085|||ANCOVA|||||6.085|-32.513|0.1755
91501528|NCT02472795|182874212|SUPERIORITY||Mean Difference (Final Values)|-39.311|STANDARD_ERROR_OF_MEAN|10.096||0.0003|TWO_SIDED|95.0|-59.552|-19.069|||ANCOVA|||||-19.069|-59.552|0.0003
91501529|NCT02472795|182874212|SUPERIORITY||Mean Difference (Final Values)|-47.278|STANDARD_ERROR_OF_MEAN|9.329|<|0.0001|TWO_SIDED|95.0|-65.981|-28.574|||ANCOVA|||||-28.574|-65.981|<0.0001
91745393|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
91745394|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|52.53|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|52.53|<0.001
91745395|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.38||||0.186|TWO_SIDED|95.0|-3.05|15.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.81|-3.05|0.186
91745396|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.703|TWO_SIDED|95.0|-8.18|12.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.12|-8.18|0.703
91745397|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.06||||0.312|TWO_SIDED|95.0|-4.68|14.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.79|-4.68|0.312
91745398|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
91745399|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
91745400|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
91745401|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
91501530|NCT02472795|182874212|SUPERIORITY||Mean Difference (Final Values)|-56.452|STANDARD_ERROR_OF_MEAN|10.541|<|0.0001|TWO_SIDED|95.0|-77.585|-35.32|||ANCOVA|||||-35.320|-77.585|<0.0001
91501531|NCT04318080|182874230|SUPERIORITY|Analysis tested whether ORR with tislelizumab was superior to a historical ORR of 45% using a one-sided binomial exact test (α = 0.05).|Z-test|2.62||||0.0044|TWO_SIDED|||||One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%.|Binomial Exact Test|||The primary analysis was conducted on both cohorts combined, A binomial exact test was performed to test the null hypothesis (H0: ORR = 45% based on previous clinical trials) and alternative hypothesis (ORR \>45%). If the one-sided p-value was ≤ 0.05, tislelizumab was considered to statistically significantly increase ORR compared to the historical control.||||0.0044
91501532|NCT01536379|182874238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|95.0|-109.5|40.7||||||||40.7|-109.5|
91501533|NCT01536379|182874259|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|204.35|||||TWO_SIDED|95.0|90.0|550.0|||||Week 24 comparison|||550.00|90.00|
91501534|NCT01536379|182874259|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-33.06|||||TWO_SIDED|95.0|-169.84|25.0|||||Week 52 comparison|||25.00|-169.84|
91501535|NCT01536379|182874260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1232.4|STANDARD_ERROR_OF_MEAN|25735.56|||TWO_SIDED|95.0|-50457.0|52921.8|||||Week 24 comparison|||52921.8|-50457.0|
91501536|NCT01536379|182874260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13128.35|STANDARD_ERROR_OF_MEAN|24165.18|||TWO_SIDED|95.0|-61868.9|35612.2|||||Week 52 comparison|||35612.2|-61868.9|
91501537|NCT01536379|182874261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-31.3|3.7|||||Week 24 comparison|||3.7|-31.3|
91531509|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|10.5|27.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.5|10.5|<0.001
91745402|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91501538|NCT01536379|182874261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|7.68|||TWO_SIDED|95.0|-8.6|22.2|||||Week 52 comparison|||22.2|-8.6|
91501539|NCT01536379|182874262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2791.0|STANDARD_ERROR_OF_MEAN|4651.1|||TWO_SIDED|95.0|-12105.0|6524.0|||||Week 24 comparison|||6524|-12105|
91501540|NCT01536379|182874262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-458.0|STANDARD_ERROR_OF_MEAN|4501.8|||TWO_SIDED|95.0|-9487.0|8572.0|||||Week 52 comparison|||8572|-9487|
91501541|NCT01536379|182874263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.156|||TWO_SIDED|95.0|-3.59|1.01|||||Week 24 comparison|||1.01|-3.59|
91501542|NCT01536379|182874263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|95.0|-1.24|2.82|||||Week 52 comparison|||2.82|-1.24|
91501543|NCT01536379|182874264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30326.9|STANDARD_ERROR_OF_MEAN|34677.86|||TWO_SIDED|95.0|-100559.1|39905.3|||||Week 24 comparison|||39905.3|-100559.1|
91501544|NCT01536379|182874264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46955.3|STANDARD_ERROR_OF_MEAN|32594.81|||TWO_SIDED|95.0|-113218.9|19308.3|||||Week 52 comparison|||19308.3|-113218.9|
91501545|NCT01536379|182874265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-10.1|4.2|||||Week 24 comparison|||4.2|-10.1|
91531510|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|10.8|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||23.8|10.8|<0.001
91745403|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91501546|NCT01536379|182874265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-7.2|6.3|||||Week 52 comparison|||6.3|-7.2|
91501547|NCT01536379|182874266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|648.3|STANDARD_ERROR_OF_MEAN|12618.44|||TWO_SIDED|95.0|-24661.1|25957.7|||||Week 24 comparison|||25957.7|-24661.1|
91501548|NCT01536379|182874266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5618.9|STANDARD_ERROR_OF_MEAN|12153.03|||TWO_SIDED|95.0|-29994.8|18757.0|||||Week 52 comparison|||18757.0|-29994.8|
91501549|NCT01536379|182874267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-3.2|3.5|||||Week 24 comparison|||3.5|-3.2|
91501550|NCT01536379|182874267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-3.5|2.3|||||Week 52 comparison|||2.3|-3.5|
91501551|NCT01536379|182874268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|1.255|||TWO_SIDED|95.0|-4.07|0.98|||||Week 24 comparison|||0.98|-4.07|
91501552|NCT01536379|182874268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.329|||TWO_SIDED|95.0|-3.68|1.67|||||Week 52 comparison|||1.67|-3.68|
91501553|NCT01536379|182874269|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.067|||||TWO_SIDED|95.0|-0.638|0.505|||||Week 24 comparison|||0.505|-0.638|
91501554|NCT01536379|182874269|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.267|||||TWO_SIDED|95.0|-0.838|0.305|||||Week 52 comparison|||0.305|-0.838|
91501555|NCT01536379|182874270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|52.06|||TWO_SIDED|95.0|-105.9|100.3|||||Week 24 comparison|||100.3|-105.9|
91501556|NCT01536379|182874270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|47.52|||TWO_SIDED|95.0|-107.1|81.4|||||Week 52 comparison|||81.4|-107.1|
91501557|NCT01536379|182874271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-31.56|5.71|||||Week 24 comparison|||5.71|-31.56|
91501558|NCT01536379|182874271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|8.315|||TWO_SIDED|95.0|-19.11|13.72|||||Week 52 comparison|||13.72|-19.11|
91501559|NCT01536379|182874272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.225|||TWO_SIDED|95.0|-4.84|3.96||||||||3.96|-4.84|
91501560|NCT05027438|182874310|SUPERIORITY||Mean Difference (Net)|-7.58|STANDARD_DEVIATION|5.19|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 1.42 (large \>=0.35)|||<0.001
91501561|NCT05027438|182874310|SUPERIORITY||Mean Difference (Net)|-7.06|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 1.54 (large \>=0.35)|||<0.001
91501562|NCT05027438|182874311|SUPERIORITY||Mean Difference (Net)|58.55|STANDARD_DEVIATION|43.98||0.004|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to post-treatment||||0.004
91501563|NCT05027438|182874311|SUPERIORITY||Mean Difference (Net)|62.26|STANDARD_DEVIATION|54.93||0.005|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to 3-month follow-up||||0.005
91501564|NCT05027438|182874312|SUPERIORITY||Proportion (%)|31.8||||0.052|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to post-treatment||||0.052
91501565|NCT05027438|182874312|SUPERIORITY||Proportion (%)|60.0|||<|0.001|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to 3-month follow-up||||<0.001
91501566|NCT05027438|182874313|SUPERIORITY||Mean Difference (Net)|-16.67|STANDARD_DEVIATION|20.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.54 (large \>=0.35)|||<0.001
91745404|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91501567|NCT05027438|182874313|SUPERIORITY||Mean Difference (Net)|-17.11|STANDARD_DEVIATION|22.11|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.47 (large \>=0.35)|||<0.001
91501568|NCT05027438|182874314|SUPERIORITY||Mean Difference (Net)|-6.24|STANDARD_DEVIATION|20.34||0.101|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.10 (small \>=0.02)|||0.101
91501569|NCT05027438|182874314|SUPERIORITY||Mean Difference (Net)|-10.34|STANDARD_DEVIATION|18.28|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.34 (medium; large \>=0.35)|||<0.001
91501570|NCT05027438|182874315|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)|baseline to post-treatment|effect size (f2) = 0.87 (large \>=0.35)|||<0.001
91501571|NCT05027438|182874315|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)|baseline to 3-month follow-up|effect size (f2) = 0.96 (large \>=0.35)|||<0.001
91501572|NCT05027438|182874316|SUPERIORITY||Mean Difference (Net)|-7.48|STANDARD_DEVIATION|6.08|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.14 (large \>=0.35)|||<0.001
91501573|NCT05027438|182874316|SUPERIORITY||Mean Difference (Net)|-7.82|STANDARD_DEVIATION|5.62|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.21 (large \>=0.35)|||<0.001
91501574|NCT05027438|182874317|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.21||0.22|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)||effect size (f2) = 0.18 (medium \>=0.15)|||0.22
91501575|NCT05027438|182874317|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)||effect size (f2) = 1.99 (large \>=0.35)|||<0.001
91501576|NCT04729127|182874318|OTHER|||||||0.79|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.79
91501577|NCT04729127|182874318|OTHER|||||||0.27|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.27
91501578|NCT04729127|182874319|OTHER|||||||0.04|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.04
91501579|NCT04729127|182874319|OTHER|||||||0.02|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.02
91501580|NCT04729127|182874320|OTHER|||||||0.78|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.78
91501581|NCT04729127|182874320|OTHER|||||||0.89|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.89
91501582|NCT04729127|182874321|OTHER|||||||0.07|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.07
91501583|NCT04729127|182874321|OTHER|||||||0.88|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.88
91501584|NCT04729127|182874324|OTHER|||||||0.26|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.26
91501585|NCT04729127|182874324|OTHER|||||||0.74|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.74
91501586|NCT02807350|182874330|OTHER||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|7.0|29.0||||||\>1 point analysis||29|7|
91745405|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
91745406|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
91745407|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
91745408|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
91745409|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745410|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91501587|NCT02807350|182874330|OTHER|\>2 points analysis|Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|10.0|28.0||||||||28|10|
91501588|NCT02807350|182874331|OTHER|\>1 analysis|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-7.0|15.0||||||||15|-7|
91501589|NCT02807350|182874331|OTHER|\>2 analysis|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|-2.0|17.0||||||||17|-2|
91501590|NCT03388138|182874351|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0017|STANDARD_ERROR_OF_MEAN|0.01169|||TWO_SIDED|95.0|-0.021|0.025|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.025|-0.021|
91501591|NCT03388138|182874352|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0007|STANDARD_ERROR_OF_MEAN|0.01158|||TWO_SIDED|95.0|-0.022|0.024|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.024|-0.022|
91531511|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|12.6||||0.002|TWO_SIDED|95.0|4.5|20.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||20.7|4.5|0.002
91501592|NCT02436759|182874370|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Two-sided t-test with treatment as a fixed factor and baseline score as a covariate||||||<0.0001
91501593|NCT02436759|182874371|SUPERIORITY|||||||0.12|||||||ANCOVA|Two-sided t-test||||||0.12
91501594|NCT01912287|182874383|SUPERIORITY||Odds Ratio (OR)|2.46||||0.03|TWO_SIDED|95.0|1.12|5.42|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. SE at post-treatment||5.42|1.12|.03
91501595|NCT01912287|182874383|SUPERIORITY||Odds Ratio, log|5.0|||<|0.001|TWO_SIDED|95.0|2.12|11.82|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of CBT vs. SE at post-treatment||11.82|2.12|<.001
91501596|NCT01912287|182874383|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.24|1.03|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. CBT at post-treatment||1.03|0.24|0.07
91501597|NCT04600414|182874393|SUPERIORITY||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.38|||Multi-level model to account for cluster|||||0.38|0.03|<0.001
91501598|NCT04600414|182874394|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.532|TWO_SIDED|95.0|-4.97|2.57|||Multi-level model to account for cluster|||||2.57|-4.97|0.532
91501599|NCT00391274|182874438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.1326||95.0|0.76|8.25||Logistic regression of best overall tumor response (complete response + partial response).|Regression, Logistic|Treatment was the only covariate.||||8.25|0.76|0.1326
91501600|NCT00391274|182874439|SUPERIORITY_OR_OTHER|||||||0.7704||95.0|||||Log Rank|||||||0.7704
91501601|NCT00391274|182874439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7784||95.0|0.75|1.46|||Regression, Cox|Treatment was the only covariate.||||1.46|0.75|0.7784
91501602|NCT00391274|182874442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.4921||95.0|0.78|1.68||P-value for Overall Survival (up to 24 months)|Regression, Cox|Treatment was the only covariate.||||1.68|0.78|0.4921
91501603|NCT00391274|182874442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9256|TWO_SIDED|95.0|0.74|1.4||P-value for Overall Survival (up to 30 months)|Regression, Cox|||||1.40|0.74|0.9256
91501604|NCT00553150|182874454|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|70.0|||||TWO_SIDED|||||||||||||
91501605|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.8096|||<|0.0001|TWO_SIDED|95.0|15.0866|26.5327|||Mixed Models Analysis|Mixed-effect model was implemented with Restricted Maximum Likelihood (REML) estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95 percent (%) Confidence Interval (CI) were obtained from the model.||26.5327|15.0866|<0.0001
91501606|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4625|||<|0.0001|TWO_SIDED|95.0|18.7321|30.1929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1929|18.7321|<0.0001
91531512|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|12.1||||0.002|TWO_SIDED|95.0|4.0|20.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.1|4.0|0.002
91531513|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|7.2||||0.016|TWO_SIDED|95.0|0.9|13.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||13.5|0.9|0.016
91531514|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|5.2||||0.18|TWO_SIDED|95.0|-2.7|13.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.0|-2.7|0.18
91501607|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5792||||0.8428|TWO_SIDED|95.0|-6.3385|5.18|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.1800|-6.3385|0.8428
91501608|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9993||||0.4957|TWO_SIDED|95.0|-7.7832|3.7845|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.7845|-7.7832|0.4957
91501609|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9683||||0.7431|TWO_SIDED|95.0|-4.8567|6.7932|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.7932|-4.8567|0.7431
91501610|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.3889|||<|0.0001|TWO_SIDED|95.0|-27.1044|-15.6734|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.6734|-27.1044|<0.0001
91501611|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.809|||<|0.0001|TWO_SIDED|95.0|-28.5584|-17.0596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.0596|-28.5584|<0.0001
91501612|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-19.8414|||<|0.0001|TWO_SIDED|95.0|-25.6435|-14.0393|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.0393|-25.6435|<0.0001
91501613|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0418|||<|0.0001|TWO_SIDED|95.0|-30.6705|-19.413|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.4130|-30.6705|<0.0001
91745411|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91501614|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4618|||<|0.0001|TWO_SIDED|95.0|-32.1455|-20.7782|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.7782|-32.1455|<0.0001
91501615|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4943|||<|0.0001|TWO_SIDED|95.0|-29.244|-17.7445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.7445|-29.2440|<0.0001
91531515|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|7.9||||0.03|TWO_SIDED|95.0|0.3|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.6|0.3|0.030
91745412|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745413|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745414|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745415|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745416|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745417|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745418|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745419|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745420|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745421|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745422|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745423|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745424|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745425|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91531516|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|13.2|||<|0.001|TWO_SIDED|95.0|6.7|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||19.7|6.7|<0.001
91745426|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91501616|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4538||||0.572|TWO_SIDED|95.0|-6.5274|3.6198|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.6198|-6.5274|0.5720
91501617|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9938||||0.0006|TWO_SIDED|95.0|-14.0695|-3.918|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.9180|-14.0695|0.0006
91501618|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8686||||0.4704|TWO_SIDED|95.0|-3.2342|6.9713|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9713|-3.2342|0.4704
91501619|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0725||||0.4255|TWO_SIDED|95.0|-3.0533|7.1984|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1984|-3.0533|0.4255
91501620|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3425||||0.8959|TWO_SIDED|95.0|-5.5053|4.8204|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.8204|-5.5053|0.8959
91501621|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3224||||0.1967|TWO_SIDED|95.0|-1.7402|8.385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.3850|-1.7402|0.1967
91501622|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5264||||0.1733|TWO_SIDED|95.0|-1.5676|8.6203|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.6203|-1.5676|0.1733
91745427|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745428|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91501623|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1113||||0.6697|TWO_SIDED|95.0|-4.0285|6.2512|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2512|-4.0285|0.6697
91501624|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8623|||<|0.0001|TWO_SIDED|95.0|5.8712|15.8535|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.8535|5.8712|<0.0001
91501625|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0663|||<|0.0001|TWO_SIDED|95.0|6.0281|16.1045|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1045|6.0281|<0.0001
91501626|NCT00975481|182874466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6513||||0.001|TWO_SIDED|95.0|3.5552|13.7474|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7474|3.5552|0.0010
91531517|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|11.7||||0.003|TWO_SIDED|95.0|3.7|19.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.6|3.7|0.003
91745429|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745430|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745431|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745432|NCT01559259|183384901|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745433|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.99||||0.003|TWO_SIDED|95.0|13.32|34.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.67|13.32|0.003
91745434|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.83||||0.048|TWO_SIDED|95.0|4.59|25.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.07|4.59|0.048
91745435|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|24.98||||0.005|TWO_SIDED|95.0|13.43|36.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.53|13.43|0.005
91745436|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|16.57||||0.03|TWO_SIDED|95.0|6.25|26.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.88|6.25|0.030
91745437|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.86||||0.269|TWO_SIDED|95.0|-4.8|18.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.53|-4.80|0.269
91745438|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.95||||0.735|TWO_SIDED|95.0|-13.34|9.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.43|-13.34|0.735
91745439|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.58||||0.176|TWO_SIDED|95.0|-3.88|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.88|0.176
91745440|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.3|||<|0.001|TWO_SIDED|95.0|49.07|77.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||77.52|49.07|<0.001
91745441|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|56.81|||<|0.001|TWO_SIDED|95.0|42.28|71.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||71.34|42.28|<0.001
91501627|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6388|||<|0.0001|TWO_SIDED|95.0|10.5727|22.7049|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||22.7049|10.5727|<0.0001
91501628|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.8432|||<|0.0001|TWO_SIDED|95.0|13.7627|25.9238|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.9238|13.7627|<0.0001
91501629|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6121||||0.6029|TWO_SIDED|95.0|-7.7209|4.4967|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4967|-7.7209|0.6029
91501630|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9241||||0.3477|TWO_SIDED|95.0|-9.0571|3.2089|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.2089|-9.0571|0.3477
91501631|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0908||||0.9769|TWO_SIDED|95.0|-6.085|6.2667|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2667|-6.0850|0.9769
91501632|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2509|||<|0.0001|TWO_SIDED|95.0|-24.3155|-12.1864|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-12.1864|-24.3155|<0.0001
91501633|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5629|||<|0.0001|TWO_SIDED|95.0|-25.6616|-13.4642|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.4642|-25.6616|<0.0001
91501634|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.548|||<|0.0001|TWO_SIDED|95.0|-22.7036|-10.3923|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.3923|-22.7036|<0.0001
91501635|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4554|||<|0.0001|TWO_SIDED|95.0|-27.4199|-15.4908|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.4908|-27.4199|<0.0001
91501636|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7673|||<|0.0001|TWO_SIDED|95.0|-28.7925|-16.7422||Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Mixed Models Analysis|||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.7422|-28.7925|<0.0001
91531518|NCT02886728|182939603|SUPERIORITY||Difference in Response Rates|13.0|||<|0.001|TWO_SIDED|95.0|5.1|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||20.8|5.1|<0.001
91745442|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.57|||<|0.001|TWO_SIDED|95.0|53.58|81.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.55|53.58|<0.001
91745443|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|53.31|||<|0.001|TWO_SIDED|95.0|38.62|67.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.99|38.62|<0.001
91501637|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7524|||<|0.0001|TWO_SIDED|95.0|-25.8485|-13.6563|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.6563|-25.8485|<0.0001
91501638|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0888||||0.0006|TWO_SIDED|95.0|5.3225|18.8551|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.8551|5.3225|0.0006
91501639|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0768||||0.0038|TWO_SIDED|95.0|3.3132|16.8403|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.8403|3.3132|0.0038
91501640|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1875||||0.2257|TWO_SIDED|95.0|-10.989|2.6139|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6139|-10.9890|0.2257
91501641|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8589||||0.8042|TWO_SIDED|95.0|-7.6927|5.975|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9750|-7.6927|0.8042
91501642|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6335||||0.6399|TWO_SIDED|95.0|-8.5177|5.2506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2506|-8.5177|0.6399
91501643|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2763|||<|0.0001|TWO_SIDED|95.0|-23.0228|-9.5229|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.5229|-23.0228|<0.0001
91501644|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9477||||0.0002|TWO_SIDED|95.0|-19.7374|-6.158|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.1580|-19.7374|0.0002
91501645|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7223||||0.0001|TWO_SIDED|95.0|-20.572|-6.8727|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.8727|-20.5720|0.0001
91501646|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2643|||<|0.0001|TWO_SIDED|95.0|-20.9226|-7.606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.6060|-20.9226|<0.0001
91531519|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|10.1|||<|0.001|TWO_SIDED|95.0|6.2|13.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||13.9|6.2|<0.001
91745444|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.14|TWO_SIDED|95.0|-3.26|23.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.82|-3.26|0.140
91745445|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.98||||0.674|TWO_SIDED|95.0|-10.94|16.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.89|-10.94|0.674
91531520|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|6.3||||0.001|TWO_SIDED|95.0|1.7|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||10.9|1.7|0.001
91745446|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.58||||0.034|TWO_SIDED|95.0|1.22|27.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.93|1.22|0.034
91745447|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.32|||<|0.001|TWO_SIDED|95.0|58.25|86.39||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.39|58.25|<0.001
91745448|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.2|||<|0.001|TWO_SIDED|95.0|52.63|81.78||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.78|52.63|<0.001
91745449|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.4|||<|0.001|TWO_SIDED|95.0|58.4|86.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.40|58.40|<0.001
91745450|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.12|||<|0.001|TWO_SIDED|95.0|49.32|78.91||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.91|49.32|<0.001
91745451|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.4||||0.119|TWO_SIDED|95.0|-2.06|18.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.85|-2.06|0.119
91745452|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.616|TWO_SIDED|95.0|-8.3|13.98||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.98|-8.30|0.616
91745453|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.34||||0.125|TWO_SIDED|95.0|-2.2|18.87||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.87|-2.20|0.125
91745454|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.49|||<|0.001|TWO_SIDED|95.0|60.73|88.25||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.25|60.73|<0.001
91745455|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.38|||<|0.001|TWO_SIDED|95.0|55.05|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|55.05|<0.001
91745456|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.52|||<|0.001|TWO_SIDED|95.0|59.65|87.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.38|59.65|<0.001
91745457|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.36|||<|0.001|TWO_SIDED|95.0|54.01|82.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.71|54.01|<0.001
91745458|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.33||||0.187|TWO_SIDED|95.0|-2.99|15.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.65|-2.99|0.187
91501647|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9356||||0.0016|TWO_SIDED|95.0|-17.6548|-4.2165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.2165|-17.6548|0.0016
91531521|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|7.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||18.9|7.7|<0.001
91501648|NCT00975481|182874467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7103||||0.0008|TWO_SIDED|95.0|-18.5055|-4.9151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.9151|-18.5055|0.0008
91501649|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.009|||<|0.0001|TWO_SIDED|95.0|13.7265|34.2916|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.2916|13.7265|<0.0001
91501650|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.4156|||<|0.0001|TWO_SIDED|95.0|19.116|39.7151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||39.7151|19.1160|<0.0001
91501651|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3979||||0.2239|TWO_SIDED|95.0|-16.7479|3.9521|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.9521|-16.7479|0.2239
91531522|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|20.0|||<|0.001|TWO_SIDED|95.0|14.5|25.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.4|14.5|<0.001
91745459|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.79||||0.881|TWO_SIDED|95.0|-9.42|10.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.99|-9.42|0.881
91745460|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.05||||0.311|TWO_SIDED|95.0|-4.6|14.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.71|-4.60|0.311
91745461|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745462|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745463|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745464|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745465|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745466|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745467|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745468|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745469|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745470|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745471|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745472|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745473|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745474|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745475|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745476|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745477|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745478|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745479|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745480|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91501652|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1396||||0.4326|TWO_SIDED|95.0|-14.5328|6.2526|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2526|-14.5328|0.4326
91501653|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7283||||0.7447|TWO_SIDED|95.0|-12.195|8.7383|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7383|-12.1950|0.7447
91501654|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.4069|||<|0.0001|TWO_SIDED|95.0|-40.6795|-20.1343|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1343|-40.6795|<0.0001
91501655|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.1487|||<|0.0001|TWO_SIDED|95.0|-38.4812|-17.8161|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8161|-38.4812|<0.0001
91501656|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7374|||<|0.0001|TWO_SIDED|95.0|-36.1651|-15.3096|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.3096|-36.1651|<0.0001
91501657|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.8134|||<|0.0001|TWO_SIDED|95.0|-45.9257|-25.7012|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-25.7012|-45.9257|<0.0001
91501658|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.5552|||<|0.0001|TWO_SIDED|95.0|-43.7675|-23.3429|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-23.3429|-43.7675|<0.0001
91531523|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|11.4|||<|0.001|TWO_SIDED|95.0|4.8|18.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.0|4.8|<0.001
91501659|NCT00975481|182874468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1439|||<|0.0001|TWO_SIDED|95.0|-41.4754|-20.8124|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.8124|-41.4754|<0.0001
91501660|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.8779|||<|0.0001|TWO_SIDED|95.0|19.5658|30.1899|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1899|19.5658|<0.0001
91531524|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.4|23.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.2|9.4|<0.001
91531525|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|18.1|31.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||31.5|18.1|<0.001
91531526|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|16.1|||<|0.001|TWO_SIDED|95.0|7.7|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||24.5|7.7|<0.001
91745481|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745482|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745483|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745484|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745485|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745486|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745487|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91501661|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.9857|||<|0.0001|TWO_SIDED|95.0|20.667|31.3043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||31.3043|20.6670|<0.0001
91501662|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0544||||0.4489|TWO_SIDED|95.0|-3.2911|7.3998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.3998|-3.2911|0.4489
91501663|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5743||||0.8329|TWO_SIDED|95.0|-4.7941|5.9427|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9427|-4.7941|0.8329
91745488|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91531527|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|9.0|25.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||25.7|9.0|<0.001
91745489|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745490|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91531528|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|15.9|||<|0.001|TWO_SIDED|95.0|8.9|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||22.8|8.9|<0.001
91745491|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745492|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745493|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745494|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745495|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745496|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745497|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745498|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745499|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745500|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91531529|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|11.3||||0.006|TWO_SIDED|95.0|2.7|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||20.0|2.7|0.006
91745501|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745502|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745503|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745504|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745505|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745506|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745507|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745508|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745509|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745510|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745511|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745512|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745513|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91531530|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|12.4||||0.002|TWO_SIDED|95.0|3.9|21.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.0|3.9|0.002
91745514|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745515|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745516|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745517|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745518|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745519|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745520|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745521|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745522|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745523|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745524|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745525|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91745526|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745527|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91531531|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|12.0|||<|0.001|TWO_SIDED|95.0|5.1|19.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||19.0|5.1|<0.001
91501664|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6863||||0.5387|TWO_SIDED|95.0|-3.7203|7.0929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.0929|-3.7203|0.5387
91501665|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8235|||<|0.0001|TWO_SIDED|95.0|-28.1283|-17.5187|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.5187|-28.1283|<0.0001
91531532|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|7.0||||0.09|TWO_SIDED|95.0|-1.7|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||15.7|-1.7|0.090
91745528|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91531533|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|10.0||||0.014|TWO_SIDED|95.0|1.4|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||18.6|1.4|0.014
91531534|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|13.9|||<|0.001|TWO_SIDED|95.0|7.0|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||20.9|7.0|<0.001
91745529|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745530|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745531|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
91745532|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
91531535|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|11.1||||0.008|TWO_SIDED|95.0|2.5|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.7|2.5|0.008
91501666|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3036|||<|0.0001|TWO_SIDED|95.0|-29.64|-18.9672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9672|-29.6400|<0.0001
91531536|NCT02886728|182939604|SUPERIORITY||Difference in Response Rates|13.1||||0.001|TWO_SIDED|95.0|4.6|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||21.6|4.6|0.001
91531537|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|2.4||||0.018|TWO_SIDED|95.0|0.3|4.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||4.5|0.3|0.018
91501667|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.1916|||<|0.0001|TWO_SIDED|95.0|-28.5768|-17.8064|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8064|-28.5768|<0.0001
91531538|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|1.2||||0.17|TWO_SIDED|95.0|-1.2|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||3.6|-1.2|0.17
91531539|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|3.6||||0.004|TWO_SIDED|95.0|0.3|6.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||6.8|0.3|0.004
91745533|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
91745534|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
91745535|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
91745536|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
91745537|NCT01559259|183384902|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
91745538|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.17|0.45||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.45|0.17|<0.001
91745539|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.39|0.15|<0.001
91745540|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.35||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.35|0.13|<0.001
91745541|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|||<|0.001|TWO_SIDED|95.0|0.15|0.41||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.41|0.15|<0.001
91745542|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.12||||0.549|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.63|0.77|0.549
91501668|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9313|||<|0.0001|TWO_SIDED|95.0|-29.1559|-18.7066|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.7066|-29.1559|<0.0001
91501669|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4114|||<|0.0001|TWO_SIDED|95.0|-30.6869|-20.1358|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1358|-30.6869|<0.0001
91501670|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2994|||<|0.0001|TWO_SIDED|95.0|-29.6361|-18.9626|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9626|-29.6361|<0.0001
91501671|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4301||||0.5349|TWO_SIDED|95.0|-5.9725|3.1123|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.1123|-5.9725|0.5349
91501672|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1367||||0.0001|TWO_SIDED|95.0|-13.6684|-4.605|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.6050|-13.6684|0.0001
91501673|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3357||||0.5637|TWO_SIDED|95.0|-3.2244|5.8958|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.8958|-3.2244|0.5637
91501674|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4065||||0.8612|TWO_SIDED|95.0|-4.1779|4.9909|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.9909|-4.1779|0.8612
91501675|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9175||||0.6954|TWO_SIDED|95.0|-3.7022|5.5373|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.5373|-3.7022|0.6954
91501676|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7658||||0.2287|TWO_SIDED|95.0|-1.7552|7.2868|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.2868|-1.7552|0.2287
91501677|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8366||||0.4267|TWO_SIDED|95.0|-2.7158|6.389|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.3890|-2.7158|0.4267
91501678|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3476||||0.314|TWO_SIDED|95.0|-2.2429|6.9381|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9381|-2.2429|0.3140
91531540|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|9.1|||<|0.001|TWO_SIDED|95.0|5.2|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||13.1|5.2|<0.001
91745543|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.863|TWO_SIDED|95.0|0.66|1.42||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.42|0.66|0.863
91745544|NCT01559259|183384903|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.454|TWO_SIDED|95.0|0.57|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.28|0.57|0.454
91531541|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|2.4||||0.18|TWO_SIDED|95.0|-1.7|6.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||6.6|-1.7|0.18
91531542|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|2.5|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||12.6|2.5|<0.001
91745545|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-41.07|||<|0.001|TWO_SIDED|95.0|-59.56|-22.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.58|-59.56|<0.001
91745546|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.98|||<|0.001|TWO_SIDED|95.0|-59.41|-22.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.56|-59.41|<0.001
91745547|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.64|||<|0.001|TWO_SIDED|95.0|-57.49|-19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.79|-57.49|<0.001
91745548|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.11|||<|0.001|TWO_SIDED|95.0|-56.94|-19.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.28|-56.94|<0.001
91745549|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.13||||0.274|TWO_SIDED|95.0|-8.67|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-8.67|0.274
91745550|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.89||||0.304|TWO_SIDED|95.0|-8.4|2.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.62|-8.40|0.304
91745551|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.96||||0.769|TWO_SIDED|95.0|-7.41|5.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.49|-7.41|0.769
91745552|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.19|||<|0.001|TWO_SIDED|95.0|-88.0|-54.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-54.38|-88.00|<0.001
91745553|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.99|||<|0.001|TWO_SIDED|95.0|-84.26|-49.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.72|-84.26|<0.001
91745554|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.47|||<|0.001|TWO_SIDED|95.0|-84.75|-50.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.19|-84.75|<0.001
91745555|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.76|||<|0.001|TWO_SIDED|95.0|-80.45|-45.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.07|-80.45|<0.001
91745556|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.53||||0.021|TWO_SIDED|95.0|-15.55|-1.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.50|-15.55|0.021
91531543|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|13.9|25.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||25.5|13.9|<0.001
91531544|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|6.6|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||21.1|6.6|<0.001
91745557|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.337|TWO_SIDED|95.0|-12.05|4.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.07|-12.05|0.337
91745558|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.26||||0.204|TWO_SIDED|95.0|-13.28|2.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.76|-13.28|0.204
91745559|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-77.89|||<|0.001|TWO_SIDED|95.0|-92.29|-63.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-63.49|-92.29|<0.001
91745560|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.65|||<|0.001|TWO_SIDED|95.0|-86.71|-56.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.58|-86.71|<0.001
91745561|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-72.87|||<|0.001|TWO_SIDED|95.0|-88.06|-57.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.68|-88.06|<0.001
91745562|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.2|||<|0.001|TWO_SIDED|95.0|-82.87|-51.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-51.52|-82.87|<0.001
91745563|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.71||||0.007|TWO_SIDED|95.0|-18.2|-3.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.21|-18.20|0.007
91745564|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.385|TWO_SIDED|95.0|-12.86|4.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.88|-12.86|0.385
91745565|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.29||||0.162|TWO_SIDED|95.0|-14.97|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-14.97|0.162
91745566|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-76.81|||<|0.001|TWO_SIDED|95.0|-91.35|-62.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-62.27|-91.35|<0.001
91745567|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-70.6|||<|0.001|TWO_SIDED|95.0|-85.79|-55.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-55.41|-85.79|<0.001
91501679|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4724|||<|0.0001|TWO_SIDED|95.0|5.9992|14.9456|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.9456|5.9992|<0.0001
91501680|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5432|||<|0.0001|TWO_SIDED|95.0|5.032|14.0544|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.0544|5.0320|<0.0001
91501681|NCT00975481|182874469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0542|||<|0.0001|TWO_SIDED|95.0|5.494|14.6144|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.6144|5.4940|<0.0001
91501682|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4728|||<|0.0001|TWO_SIDED|95.0|9.4718|19.4737|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.4737|9.4718|<0.0001
91501683|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7284|||<|0.0001|TWO_SIDED|95.0|14.7131|24.7437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||24.7437|14.7131|<0.0001
91501684|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2088||||0.9348|TWO_SIDED|95.0|-4.8289|5.2466|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2466|-4.8289|0.9348
91501685|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7271||||0.5009|TWO_SIDED|95.0|-6.7841|3.3299|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3299|-6.7841|0.5009
91501686|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3325||||0.8975|TWO_SIDED|95.0|-5.4245|4.7595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.7595|-5.4245|0.8975
91501687|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.264|||<|0.0001|TWO_SIDED|95.0|-19.266|-9.2619|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.2619|-19.2660|<0.0001
91501688|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1999|||<|0.0001|TWO_SIDED|95.0|-21.2294|-11.1704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-11.1704|-21.2294|<0.0001
91501689|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8053|||<|0.0001|TWO_SIDED|95.0|-19.8822|-9.7283|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.7283|-19.8822|<0.0001
91501690|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5195|||<|0.0001|TWO_SIDED|95.0|-24.4361|-14.603|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.6030|-24.4361|<0.0001
91501691|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4555|||<|0.0001|TWO_SIDED|95.0|-26.423|-16.488|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.4880|-26.4230|<0.0001
91501692|NCT00975481|182874470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0609|||<|0.0001|TWO_SIDED|95.0|-25.0872|-15.0345|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.0345|-25.0872|<0.0001
91501693|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1634|||<|0.0001|TWO_SIDED|95.0|1.9014|4.4254|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4254|1.9014|<0.0001
91501694|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6706|||<|0.0001|TWO_SIDED|95.0|3.4066|5.9346|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9346|3.4066|<0.0001
91745568|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.66|||<|0.001|TWO_SIDED|95.0|-87.0|-56.31||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.31|-87.00|<0.001
91745569|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
91501695|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478||||0.8184|TWO_SIDED|95.0|-1.1217|1.4173|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4173|-1.1217|0.8184
91501696|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2211||||0.7324|TWO_SIDED|95.0|-1.054|1.4963|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4963|-1.0540|0.7324
91501697|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0946||||0.8844|TWO_SIDED|95.0|-1.1898|1.3791|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3791|-1.1898|0.8844
91501698|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0156|||<|0.0001|TWO_SIDED|95.0|-4.2754|-1.7558|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7558|-4.2754|<0.0001
91501699|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9423|||<|0.0001|TWO_SIDED|95.0|-4.2101|-1.6745|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.6745|-4.2101|<0.0001
91501700|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0688|||<|0.0001|TWO_SIDED|95.0|-4.3484|-1.7891|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7891|-4.3484|<0.0001
91501701|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5228|||<|0.0001|TWO_SIDED|95.0|-5.7651|-3.2805|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2805|-5.7651|<0.0001
91531545|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|15.8|||<|0.001|TWO_SIDED|95.0|8.5|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||23.1|8.5|<0.001
91501702|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4495|||<|0.0001|TWO_SIDED|95.0|-5.7031|-3.1959|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1959|-5.7031|<0.0001
91501703|NCT00975481|182874471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.576|||<|0.0001|TWO_SIDED|95.0|-5.8438|-3.3081|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.3081|-5.8438|<0.0001
91531546|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|17.8|||<|0.001|TWO_SIDED|95.0|11.2|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||24.4|11.2|<0.001
91531547|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.9|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||22.4|5.9|<0.001
91531548|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|14.0|||<|0.001|TWO_SIDED|95.0|5.8|22.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.2|5.8|<0.001
91531549|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|13.7|||<|0.001|TWO_SIDED|95.0|6.9|20.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||20.5|6.9|<0.001
91531550|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|5.0||||0.2|TWO_SIDED|95.0|-3.3|13.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.3|-3.3|0.20
91531551|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|7.3||||0.056|TWO_SIDED|95.0|-1.0|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.7|-1.0|0.056
91501704|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0798|||<|0.0001|TWO_SIDED|95.0|34.0453|58.1142|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||58.1142|34.0453|<0.0001
91501705|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.8771|||<|0.0001|TWO_SIDED|95.0|37.8247|61.9295|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.9295|37.8247|<0.0001
91501706|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5797||||0.9248|TWO_SIDED|95.0|-12.6918|11.5325|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.5325|-12.6918|0.9248
91501707|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3632||||0.5857|TWO_SIDED|95.0|-15.5264|8.8|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.8000|-15.5264|0.5857
91501708|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4225||||0.4768|TWO_SIDED|95.0|-7.827|16.6719|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.6719|-7.8270|0.4768
91531552|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|18.0|||<|0.001|TWO_SIDED|95.0|11.3|24.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||24.8|11.3|<0.001
91745570|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.7||||0.007|TWO_SIDED|95.0|-19.86|-3.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.55|-19.86|0.007
91501709|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6594|||<|0.0001|TWO_SIDED|95.0|-58.6804|-34.6385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.6385|-58.6804|<0.0001
91501710|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.443|||<|0.0001|TWO_SIDED|95.0|-61.5346|-37.3514|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.3514|-61.5346|<0.0001
91501711|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6573|||<|0.0001|TWO_SIDED|95.0|-53.86|-29.4546|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.4546|-53.8600|<0.0001
91531553|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|10.3||||0.01|TWO_SIDED|95.0|1.9|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.6|1.9|0.010
91745571|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.94||||0.31|TWO_SIDED|95.0|-14.34|4.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.46|-14.34|0.310
91745572|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-7.36||||0.126|TWO_SIDED|95.0|-16.63|1.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.90|-16.63|0.126
91745573|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-75.64|||<|0.001|TWO_SIDED|95.0|-90.35|-60.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-60.93|-90.35|<0.001
91501712|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.4567|||<|0.0001|TWO_SIDED|95.0|-62.2925|-38.621|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.6210|-62.2925|<0.0001
91501713|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.2403|||<|0.0001|TWO_SIDED|95.0|-65.1923|-41.2882|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-41.2882|-65.1923|<0.0001
91501714|NCT00975481|182874472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.4546|||<|0.0001|TWO_SIDED|95.0|-57.5459|-33.3633|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-33.3633|-57.5459|<0.0001
91501715|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.845|||<|0.0001|TWO_SIDED|95.0|34.6464|59.0436|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.0436|34.6464|<0.0001
91501716|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5013|||<|0.0001|TWO_SIDED|95.0|45.3036|69.6991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.6991|45.3036|<0.0001
91745574|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.43|||<|0.001|TWO_SIDED|95.0|-81.99|-50.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.88|-81.99|<0.001
91745575|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-69.33|||<|0.001|TWO_SIDED|95.0|-84.96|-53.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.71|-84.96|<0.001
91745576|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
91501717|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0913||||0.4129|TWO_SIDED|95.0|-17.3421|7.1595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1595|-17.3421|0.4129
91501718|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1893||||0.8488|TWO_SIDED|95.0|-13.4954|11.1168|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1168|-13.4954|0.8488
91501719|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1995||||0.4086|TWO_SIDED|95.0|-7.1963|17.5954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||17.5954|-7.1963|0.4086
91745577|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.61||||0.016|TWO_SIDED|95.0|-19.02|-2.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-2.19|-19.02|0.016
91745578|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.69||||0.895|TWO_SIDED|95.0|-10.69|9.32||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.32|-10.69|0.895
91501720|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.9363|||<|0.0001|TWO_SIDED|95.0|-64.1108|-39.7618|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-39.7618|-64.1108|<0.0001
91501721|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.0343|||<|0.0001|TWO_SIDED|95.0|-60.2801|-35.7885|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7885|-60.2801|<0.0001
91501722|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6455|||<|0.0001|TWO_SIDED|95.0|-53.9964|-29.2946|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.2946|-53.9964|<0.0001
91501723|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.5926|||<|0.0001|TWO_SIDED|95.0|-74.5881|-50.5971|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-50.5971|-74.5881|<0.0001
91501724|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.6906|||<|0.0001|TWO_SIDED|95.0|-70.7965|-46.5847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-46.5847|-70.7965|<0.0001
91501725|NCT00975481|182874473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.3018|||<|0.0001|TWO_SIDED|95.0|-64.5427|-40.0609|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.0609|-64.5427|<0.0001
91501726|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4604||||0.0016|TWO_SIDED|95.0|6.321|26.5998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||26.5998|6.3210|0.0016
91501727|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9971|||<|0.0001|TWO_SIDED|95.0|17.8247|38.1696|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||38.1696|17.8247|<0.0001
91501728|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1425||||0.8254|TWO_SIDED|95.0|-11.3591|9.0742|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.0742|-11.3591|0.8254
91501729|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.747||||0.8858|TWO_SIDED|95.0|-9.5075|11.0015|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.0015|-9.5075|0.8858
91501730|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4279||||0.5128|TWO_SIDED|95.0|-6.8972|13.7529|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7529|-6.8972|0.5128
91745579|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.09||||0.308|TWO_SIDED|95.0|-14.8|4.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.62|-14.80|0.308
91531554|NCT02886728|182939605|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|7.0|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.8|7.0|<0.001
91745580|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.36|||<|0.001|TWO_SIDED|95.0|-86.58|-56.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.13|-86.58|<0.001
91745581|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.11|||<|0.001|TWO_SIDED|95.0|-78.04|-46.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.19|-78.04|<0.001
91745582|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-64.57|||<|0.001|TWO_SIDED|95.0|-80.64|-48.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.50|-80.64|<0.001
91745583|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-59.84|||<|0.001|TWO_SIDED|95.0|-76.12|-43.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-43.55|-76.12|<0.001
91745584|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.49||||0.028|TWO_SIDED|95.0|-21.63|-1.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.35|-21.63|0.028
91745585|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.88||||0.747|TWO_SIDED|95.0|-13.15|9.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.38|-13.15|0.747
91745586|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.88||||0.303|TWO_SIDED|95.0|-16.88|5.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.12|-16.88|0.303
91745587|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.49|||<|0.001|TWO_SIDED|95.0|-78.64|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-78.64|<0.001
91745588|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-60.09|||<|0.001|TWO_SIDED|95.0|-76.15|-44.02||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-44.02|-76.15|<0.001
91745589|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-63.45|||<|0.001|TWO_SIDED|95.0|-79.64|-47.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.27|-79.64|<0.001
91745590|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.41|||<|0.001|TWO_SIDED|95.0|-70.1|-36.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.72|-70.10|<0.001
91745591|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-9.14||||0.137|TWO_SIDED|95.0|-21.18|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-21.18|0.137
91745592|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.34||||0.311|TWO_SIDED|95.0|-18.39|5.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.71|-18.39|0.311
91501731|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6028||||0.0008|TWO_SIDED|95.0|-27.7485|-7.4572|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.4572|-27.7485|0.0008
91501732|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7134||||0.0028|TWO_SIDED|95.0|-25.9136|-5.5132|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.5132|-25.9136|0.0028
91501733|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0325||||0.0135|TWO_SIDED|95.0|-23.3295|-2.7355|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7355|-23.3295|0.0135
91501734|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.1396|||<|0.0001|TWO_SIDED|95.0|-39.1071|-19.1721|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.1721|-39.1071|<0.0001
91501735|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.2502|||<|0.0001|TWO_SIDED|95.0|-37.3224|-17.178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.1780|-37.3224|<0.0001
91531555|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.29|-0.17||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.17|-0.29|<0.001
91745593|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.23||||0.067|TWO_SIDED|95.0|-22.97|0.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.52|-22.97|0.067
91745594|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-51.54|||<|0.001|TWO_SIDED|95.0|-68.42|-34.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-34.66|-68.42|<0.001
91745595|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-57.01|||<|0.001|TWO_SIDED|95.0|-73.27|-40.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.76|-73.27|<0.001
91745596|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.21|||<|0.001|TWO_SIDED|95.0|-70.16|-36.26||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.26|-70.16|<0.001
91745597|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.82|||<|0.001|TWO_SIDED|95.0|-64.81|-30.83||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.83|-64.81|<0.001
91745598|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.52||||0.604|TWO_SIDED|95.0|-16.89|9.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.85|-16.89|0.604
91745599|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.78||||0.184|TWO_SIDED|95.0|-21.5|3.94||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.94|-21.50|0.184
91745600|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.43||||0.34|TWO_SIDED|95.0|-19.56|6.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.70|-19.56|0.340
91745601|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.27|||<|0.001|TWO_SIDED|95.0|-57.67|-22.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.88|-57.67|<0.001
91745602|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.24|||<|0.001|TWO_SIDED|95.0|-64.21|-30.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.27|-64.21|<0.001
91745603|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-43.15|||<|0.001|TWO_SIDED|95.0|-60.57|-25.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-25.72|-60.57|<0.001
91501736|NCT00975481|182874474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5693|||<|0.0001|TWO_SIDED|95.0|-34.7614|-14.3772|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.3772|-34.7614|<0.0001
91501737|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2535||||0.0005|TWO_SIDED|95.0|0.5623|1.9446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.9446|0.5623|0.0005
91501738|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.501|||<|0.0001|TWO_SIDED|95.0|2.8073|4.1948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.1948|2.8073|<0.0001
91501739|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3418||||0.3347|TWO_SIDED|95.0|-0.3559|1.0396|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0396|-0.3559|0.3347
91501740|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3208||||0.3678|TWO_SIDED|95.0|-0.3808|1.0225|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0225|-0.3808|0.3678
91501741|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.9197|TWO_SIDED|95.0|-0.6686|0.7406|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7406|-0.6686|0.9197
91501742|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9117||||0.0099|TWO_SIDED|95.0|-1.6013|-0.222|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2220|-1.6013|0.0099
91501743|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9326||||0.0088|TWO_SIDED|95.0|-1.6269|-0.2384|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2384|-1.6269|0.0088
91501744|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2175||||0.0008|TWO_SIDED|95.0|-1.9171|-0.5178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.5178|-1.9171|0.0008
91501745|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1592|||<|0.0001|TWO_SIDED|95.0|-3.838|-2.4804|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4804|-3.8380|<0.0001
91501746|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1802|||<|0.0001|TWO_SIDED|95.0|-3.8656|-2.4947|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4947|-3.8656|<0.0001
91531556|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.28|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.28|<0.001
91745604|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-44.45|||<|0.001|TWO_SIDED|95.0|-61.55|-27.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-27.34|-61.55|<0.001
91745605|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.29||||0.548|TWO_SIDED|95.0|-9.8|18.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.38|-9.80|0.548
91745606|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.51||||0.721|TWO_SIDED|95.0|-16.2|11.18||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.18|-16.20|0.721
91745607|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.44||||0.951|TWO_SIDED|95.0|-13.47|14.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.35|-13.47|0.951
91745608|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-29.13||||0.005|TWO_SIDED|95.0|-46.66|-11.59||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.59|-46.66|0.005
91745609|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.3||||0.001|TWO_SIDED|95.0|-51.62|-16.97||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-16.97|-51.62|0.001
91745610|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-36.26|||<|0.001|TWO_SIDED|95.0|-53.8|-18.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-18.73|-53.80|<0.001
91745611|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.56|||<|0.001|TWO_SIDED|95.0|-51.77|-17.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-17.35|-51.77|<0.001
91745612|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.45||||0.455|TWO_SIDED|95.0|-8.89|19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.79|-8.89|0.455
91745613|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.43||||0.953|TWO_SIDED|95.0|-13.8|14.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.65|-13.80|0.953
91745614|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.48||||0.731|TWO_SIDED|95.0|-16.63|11.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.66|-16.63|0.731
91501747|NCT00975481|182874475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.465|||<|0.0001|TWO_SIDED|95.0|-4.1583|-2.7717|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7717|-4.1583|<0.0001
91501748|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2943|||<|0.0001|TWO_SIDED|95.0|4.0783|6.5102|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.5102|4.0783|<0.0001
91501749|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8983|||<|0.0001|TWO_SIDED|95.0|5.6799|8.1167|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.1167|5.6799|<0.0001
91501750|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6545||||0.2917|TWO_SIDED|95.0|-0.5676|1.8767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.8767|-0.5676|0.2917
91501751|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8489||||0.1738|TWO_SIDED|95.0|-0.3784|2.0763|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.0763|-0.3784|0.1738
91501752|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9372||||0.1373|TWO_SIDED|95.0|-0.3024|2.1767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.1767|-0.3024|0.1373
91501753|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6397|||<|0.0001|TWO_SIDED|95.0|-5.8537|-3.4257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.4257|-5.8537|<0.0001
91501754|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4453|||<|0.0001|TWO_SIDED|95.0|-5.6662|-3.2244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2244|-5.6662|<0.0001
91745615|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-22.63||||0.024|TWO_SIDED|95.0|-39.97|-5.29||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-5.29|-39.97|0.024
91745616|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-26.87||||0.009|TWO_SIDED|95.0|-44.12|-9.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-9.62|-44.12|0.009
91501755|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3571|||<|0.0001|TWO_SIDED|95.0|-5.5887|-3.1255|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1255|-5.5887|<0.0001
91745617|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-30.76||||0.003|TWO_SIDED|95.0|-48.36|-13.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-13.16|-48.36|0.003
91745618|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-27.26||||0.007|TWO_SIDED|95.0|-44.51|-10.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.00|-44.51|0.007
91501756|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2437|||<|0.0001|TWO_SIDED|95.0|-7.4397|-5.0477|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.0477|-7.4397|<0.0001
91501757|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0493|||<|0.0001|TWO_SIDED|95.0|-7.2568|-4.8419|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.8419|-7.2568|<0.0001
91501758|NCT00975481|182874476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9611|||<|0.0001|TWO_SIDED|95.0|-7.1812|-4.741|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.7410|-7.1812|<0.0001
91501759|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.6205|||<|0.0001|TWO_SIDED|95.0|-33.1192|-20.1219|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1219|-33.1192|<0.0001
91501760|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5724|||<|0.0001|TWO_SIDED|95.0|-39.1073|-26.0375|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.0375|-39.1073|<0.0001
91501761|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8966||||0.5685|TWO_SIDED|95.0|-4.6607|8.454|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.4540|-4.6607|0.5685
91531557|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.24|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.24|<0.001
91531558|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.001|TWO_SIDED|95.0|-0.35|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.35|<0.001
91501762|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5761||||0.2848|TWO_SIDED|95.0|-10.159|3.0068|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.0068|-10.1590|0.2848
91501763|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1754||||0.344|TWO_SIDED|95.0|-9.7855|3.4347|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.4347|-9.7855|0.3440
91531559|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|95.0|-0.23|-0.06||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.06|-0.23|<0.001
91531560|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|95.0|-0.29|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.29|<0.001
91745619|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.66||||0.516|TWO_SIDED|95.0|-9.5|18.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.82|-9.50|0.516
91501764|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5172|||<|0.0001|TWO_SIDED|95.0|22.0454|34.989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.9890|22.0454|<0.0001
91501765|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0445|||<|0.0001|TWO_SIDED|95.0|16.5383|29.5506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||29.5506|16.5383|<0.0001
91501766|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4452|||<|0.0001|TWO_SIDED|95.0|16.8772|30.0131|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.0131|16.8772|<0.0001
91501767|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.469|||<|0.0001|TWO_SIDED|95.0|28.1136|40.8244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||40.8244|28.1136|<0.0001
91501768|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9963|||<|0.0001|TWO_SIDED|95.0|22.5734|35.4192|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.4192|22.5734|<0.0001
91501769|NCT00975481|182874477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.397|||<|0.0001|TWO_SIDED|95.0|22.8946|35.8994|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.8994|22.8946|<0.0001
91501770|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.6044|||<|0.0001|TWO_SIDED|95.0|33.4091|59.7996|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.7996|33.4091|<0.0001
91501771|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7222|||<|0.0001|TWO_SIDED|95.0|37.5038|63.9407|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||63.9407|37.5038|<0.0001
91531561|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.001|TWO_SIDED|95.0|-0.35|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.20|-0.35|<0.001
91531562|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.28|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.28|<0.001
91531563|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.07|-0.26|<0.001
91745620|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.55||||0.939|TWO_SIDED|95.0|-13.63|14.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.72|-13.63|0.939
91745621|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.53||||0.536|TWO_SIDED|95.0|-18.86|9.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.80|-18.86|0.536
91501772|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6987||||0.9174|TWO_SIDED|95.0|-13.9815|12.584|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.5840|-13.9815|0.9174
91501773|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5629||||0.5002|TWO_SIDED|95.0|-17.9006|8.7749|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7749|-17.9006|0.5002
91501774|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3982||||0.3482|TWO_SIDED|95.0|-7.0337|19.8301|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.8301|-7.0337|0.3482
91501775|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3031|||<|0.0001|TWO_SIDED|95.0|-60.4869|-34.1193|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.1193|-60.4869|<0.0001
91501776|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1672|||<|0.0001|TWO_SIDED|95.0|-64.4276|-37.9069|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.9069|-64.4276|<0.0001
91745622|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-15.81||||0.107|TWO_SIDED|95.0|-33.02|1.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.41|-33.02|0.107
91745623|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-23.71||||0.019|TWO_SIDED|95.0|-40.91|-6.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-6.51|-40.91|0.019
91745624|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-28.44||||0.006|TWO_SIDED|95.0|-45.99|-10.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.88|-45.99|0.006
91745625|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-25.04||||0.012|TWO_SIDED|95.0|-42.23|-7.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-7.85|-42.23|0.012
91745626|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.16||||0.195|TWO_SIDED|95.0|-4.75|23.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.08|-4.75|0.195
91745627|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.48||||0.835|TWO_SIDED|95.0|-12.54|15.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.50|-12.54|0.835
91745628|NCT01559259|183384904|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.41||||0.542|TWO_SIDED|95.0|-18.61|9.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.79|-18.61|0.542
91745629|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|<0.001
91745630|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.83|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|< 0.001
91501777|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.2062|||<|0.0001|TWO_SIDED|95.0|-53.589|-26.8234|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.8234|-53.5890|<0.0001
91501778|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.421|||<|0.0001|TWO_SIDED|95.0|-64.3974|-38.4445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.4445|-64.3974|<0.0001
91745631|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||<|0.001|TWO_SIDED|95.0|0.73|0.99||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.99|0.73|< 0.001
91501779|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2851|||<|0.0001|TWO_SIDED|95.0|-68.3904|-42.1798|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-42.1798|-68.3904|<0.0001
91745632|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.65|0.95||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.95|0.65|< 0.001
91745633|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.174|TWO_SIDED|95.0|-0.07|0.37||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.37|-0.07|0.174
91501780|NCT00975481|182874478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.3241|||<|0.0001|TWO_SIDED|95.0|-57.5825|-31.0656|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.0656|-57.5825|<0.0001
91531564|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.043||0.002|TWO_SIDED|95.0|-0.22|-0.05||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.05|-0.22|0.002
91745634|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.722|TWO_SIDED|95.0|-0.18|0.26||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.26|-0.18|0.722
91745635|NCT01559259|183384905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.365|TWO_SIDED|95.0|-0.32|0.11||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.11|-0.32|0.365
91745636|NCT00306293|183384936|SUPERIORITY_OR_OTHER||Percent change from Placebo|-78.0|||<|0.001||95.0|||||Wilcoxon Rank Sum Test||Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo|||||<0.001
91745637|NCT00306293|183384937|SUPERIORITY_OR_OTHER||Percent change from Baseline|-77.0||||0.014||95.0|||||Wilcoxon Rank Sum||Percent change in 'percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo|||||0.014
91745638|NCT00218634|183384952|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||HLM|||We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.||||<.05
91745639|NCT00218634|183384953|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.|GLM and HLM|||||||<.05
91745640|NCT00218634|183384955|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CD4 would be more improved in the treatment condition|HLM|||follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.||||<.05
91745641|NCT02589665|183384960|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|0.7|12.27||||||||12.27|0.70|
91745642|NCT02589665|183384960|SUPERIORITY||Odds Ratio (OR)|7.22|||||TWO_SIDED|95.0|1.88|27.65||||||||27.65|1.88|
91745643|NCT02589665|183384960|SUPERIORITY||Odds Ratio (OR)|3.61|||||TWO_SIDED|95.0|0.92|14.17||||||||14.17|0.92|
91745644|NCT02589665|183384961|SUPERIORITY||Odds Ratio (OR)|3.95|||||TWO_SIDED|95.0|1.73|8.98||||||||8.98|1.73|
91745645|NCT02589665|183384961|SUPERIORITY||Odds Ratio (OR)|6.78|||||TWO_SIDED|95.0|2.94|15.63||||||||15.63|2.94|
91745646|NCT02589665|183384961|SUPERIORITY||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.23|6.29||||||||6.29|1.23|
91745647|NCT02589665|183384962|SUPERIORITY|||||||0.986|||||||Mantel Haenszel|||||||0.986
91745648|NCT02589665|183384962|SUPERIORITY|||||||0.553|||||||Mantel Haenszel|||||||0.553
91745649|NCT02589665|183384962|SUPERIORITY|||||||0.56|||||||Mantel Haenszel|||||||0.560
91745650|NCT02589665|183384963|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.8|6.55||||||||6.55|0.80|
91501781|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.3823|||<|0.0001|TWO_SIDED|95.0|-62.1244|-30.6401|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI was obtained from the model.||-30.6401|-62.1244|<0.0001
91501782|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.5199|||<|0.0001|TWO_SIDED|95.0|-67.2633|-35.7765|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7765|-67.2633|<0.0001
91501783|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0366||||0.4524|TWO_SIDED|95.0|-9.7924|21.8657|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.8657|-9.7924|0.4524
91501784|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4423||||0.762|TWO_SIDED|95.0|-13.4599|18.3446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.3446|-13.4599|0.7620
91531565|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.23|TWO_SIDED|95.0|-0.17|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.17|0.23
91531566|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.24|TWO_SIDED|95.0|-0.16|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.16|0.24
91745651|NCT02589665|183384964|SUPERIORITY||Mean Difference (Final Values)|22.9|||||TWO_SIDED|95.0|11.0|34.9||||||||34.9|11.0|
91745652|NCT02589665|183384964|SUPERIORITY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|8.7|32.3||||||||32.3|8.7|
91745653|NCT02589665|183384964|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|22.5||||||||22.5|-1.0|
91745654|NCT02589665|183384966|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.39|-0.41||||||||-0.41|-1.39|
91745655|NCT02589665|183384966|SUPERIORITY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.54|-0.59||||||||-0.59|-1.54|
91531567|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.25|-0.08||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.25|<0.001
91745656|NCT02589665|183384966|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-1.07|-0.11||||||||-0.11|-1.07|
91745657|NCT02589665|183384969|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.31|||Regression, Logistic|||||8.31|1.57|0.003
91745658|NCT02589665|183384969|SUPERIORITY||Odds Ratio (OR)|6.54|||<|0.001|TWO_SIDED|95.0|2.81|15.2|||Regression, Logistic|||||15.20|2.81|<0.001
91745659|NCT02589665|183384969|SUPERIORITY||Odds Ratio (OR)|2.27||||0.054|TWO_SIDED|95.0|0.98|5.22|||Regression, Logistic|||||5.22|0.98|0.054
91745660|NCT02589665|183384970|SUPERIORITY||Odds Ratio (OR)|0.48||||0.131|TWO_SIDED|95.0|0.19|1.24|||Regression, Logistic|||||1.24|0.19|0.131
91745661|NCT02589665|183384971|SUPERIORITY||Odds Ratio (OR)|2.25||||0.215|TWO_SIDED|95.0|0.63|8.07|||Regression, Logistic|||||8.07|0.63|0.215
91745662|NCT02589665|183384971|SUPERIORITY||Odds Ratio (OR)|7.7|||<|0.001|TWO_SIDED|95.0|2.37|25.0|||Regression, Logistic|||||25.00|2.37|<0.001
91745663|NCT02589665|183384971|SUPERIORITY||Odds Ratio (OR)|4.62||||0.012|TWO_SIDED|95.0|1.41|15.14|||Regression, Logistic|||||15.14|1.41|0.012
91745664|NCT02589665|183384972|SUPERIORITY||Odds Ratio (OR)|0.71||||0.428|TWO_SIDED|95.0|0.31|1.65|||Regression, Logistic|||||1.65|0.31|0.428
91745665|NCT01120236|183384973|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24||||0.16|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA \<= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.||||0.16
91745666|NCT01120236|183384975|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.11|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|Proportion of patients in each arm with PSA \> 4 ng/mL after seven cycles of protocol treatment were compared.||||0.11
91745667|NCT02242435|183385000|SUPERIORITY|||||||0.26||||||Adjusted for baseline WOMAC score.|ANCOVA|||||||0.26
91745668|NCT02242435|183385001|SUPERIORITY|||||||0.3||||||Adjustment for baseline WOMAC score.|ANCOVA|||||||0.30
91501785|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1573||||0.9846|TWO_SIDED|95.0|-15.8609|16.1754|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1754|-15.8609|0.9846
91501786|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.4189|||<|0.0001|TWO_SIDED|95.0|36.7157|68.1221|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||68.1221|36.7157|<0.0001
91745669|NCT04925076|183385002|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108)=.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history X sex interaction.||||.92
91745670|NCT04925076|183385002|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108) = .01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X sex interaction.||||.92
91745671|NCT04925076|183385002|SUPERIORITY|||||||0.61|||||||Chi-squared|F(1,108) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history interaction.||||.61
91745672|NCT04925076|183385002|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,108) = 6.75||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the family history X sex interaction.||||.01
91745673|NCT04925076|183385002|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,108) = 3.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of condition.||||.05
91745674|NCT04925076|183385002|SUPERIORITY|||||||0.003|||||||ANOVA|F(1,108) = 9.53||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of family history.||||.003
91745675|NCT04925076|183385002|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,108) = 2.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.12
91745676|NCT04925076|183385003|SUPERIORITY|||||||0.38|||||||ANOVA|F(1,107) = 0.78||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history X sex interaction.||||.38
91745677|NCT04925076|183385003|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,107) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X sex interaction.||||.27
91745678|NCT04925076|183385003|SUPERIORITY|||||||0.7|||||||ANOVA|F(1,107) = 0.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history interaction.||||.70
91745679|NCT04925076|183385003|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,107) = 3.87||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the family history X sex interaction.||||.05
91745680|NCT04925076|183385003|SUPERIORITY|||||||0.03|||||||ANOVA|F(1,107) = 5.18||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of condition.||||.03
91745681|NCT04925076|183385003|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,107) = 2.24||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of family history.||||.14
91745682|NCT04925076|183385003|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,107) = 17.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of sex.||||<.001
91745683|NCT04925076|183385004|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,107) = 0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history X sex interaction.||||.83
91745684|NCT04925076|183385004|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,107) = 2.43||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X sex interaction.||||.12
91745685|NCT04925076|183385004|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,107) = 1.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history interaction.||||.25
91745686|NCT04925076|183385004|SUPERIORITY|||||||0.58|||||||ANOVA|F(1,107) = 0.31||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the family history X sex interaction.||||.58
91745687|NCT04925076|183385004|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,107) = 0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of condition.||||.90
91501787|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.8246|||<|0.0001|TWO_SIDED|95.0|33.0228|64.6264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||64.6264|33.0228|<0.0001
91501788|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.5395|||<|0.0001|TWO_SIDED|95.0|30.5968|62.4823|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||62.4823|30.5968|<0.0001
91531568|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.077|TWO_SIDED|95.0|-0.2|0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.01|-0.20|0.077
91745688|NCT04925076|183385004|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,107) = .004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of family history.||||.95
91745689|NCT04925076|183385004|SUPERIORITY|||||||0.68|||||||ANOVA|F(1,107) = 0.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of sex.||||.68
91745690|NCT04925076|183385005|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,107) = 0.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history X sex interaction.||||.36
91745691|NCT04925076|183385005|SUPERIORITY|||||||0.24|||||||ANOVA|F(1,108) = 1.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X sex interaction.||||.24
91745692|NCT04925076|183385005|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,108) = 0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history interaction.||||.60
91501789|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5565|||<|0.0001|TWO_SIDED|95.0|42.0679|73.0451|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||73.0451|42.0679|<0.0001
91745693|NCT04925076|183385005|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,108) = 0.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the family history X sex interaction.||||.99
91745694|NCT04925076|183385005|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,108) = 139.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of condition.||||<.001
91745695|NCT04925076|183385005|SUPERIORITY|||||||0.84|||||||ANOVA|F(1,108) = 0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of family history.||||.84
91745696|NCT04925076|183385005|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,108) = 0.30||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of sex.||||.59
91745697|NCT04925076|183385006|SUPERIORITY|||||||0.66|||||||ANOVA|F(1,93)=0.19||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.66
91745698|NCT04925076|183385006|SUPERIORITY|||||||0.41|||||||ANOVA|F(1,93)=0.69||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.41
91745699|NCT04925076|183385006|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.74||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
91745700|NCT04925076|183385006|SUPERIORITY|||||||0.22|||||||ANOVA|F(1,93)=1.54||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.22
91745701|NCT04925076|183385006|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.06
91745702|NCT04925076|183385006|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.99
91501790|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.9622|||<|0.0001|TWO_SIDED|95.0|38.3293|69.5952|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.5952|38.3293|<0.0001
91745703|NCT04925076|183385006|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=2.88||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of sex.||||.09
91745704|NCT04925076|183385007|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.55
91745705|NCT04925076|183385007|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.36
91745706|NCT04925076|183385007|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.36
91745707|NCT04925076|183385007|SUPERIORITY|||||||0.17|||||||ANOVA|F(1,93)=1.93||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.17
91745708|NCT04925076|183385007|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of condition.||||.55
91501791|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.6772|||<|0.0001|TWO_SIDED|95.0|35.866|67.4884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||67.4884|35.8660|<0.0001
91745709|NCT04925076|183385007|SUPERIORITY|||||||0.43|||||||ANOVA|F(1,93)=0.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of family history.||||.43
91745710|NCT04925076|183385007|SUPERIORITY|||||||0.33|||||||ANOVA|F(1,93)=0.96||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.33
91745711|NCT04925076|183385008|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.34
91745712|NCT04925076|183385008|SUPERIORITY|||||||0.88|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.88
91745713|NCT04925076|183385008|SUPERIORITY|||||||0.56|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.56
91745714|NCT04925076|183385008|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.90
91745715|NCT04925076|183385008|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.59||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.45
91745716|NCT04925076|183385008|SUPERIORITY|||||||0.85|||||||ANOVA|F(1,93)=0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.85
91745717|NCT04925076|183385008|SUPERIORITY|||||||0.64|||||||ANOVA|F(1,93)=0.22||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex. Here we report the results of the analysis of the main effect of sex.||||.64
91501792|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.4454||||0.0003|TWO_SIDED|95.0|17.7051|57.1857|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||57.1857|17.7051|0.0003
91745718|NCT04925076|183385009|SUPERIORITY|||||||0.3|||||||ANOVA|F(1,93)=1.07||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.30
91501793|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.6714|||<|0.0001|TWO_SIDED|95.0|22.2888|61.054|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.0540|22.2888|<0.0001
91501794|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7583||||0.0744|TWO_SIDED|95.0|-37.2956|1.7789|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7789|-37.2956|0.0744
91501795|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5551||||0.3458|TWO_SIDED|95.0|-29.5573|10.4471|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||10.4471|-29.5573|0.3458
91745719|NCT04925076|183385009|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.11
91745720|NCT04925076|183385009|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
91745721|NCT04925076|183385009|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the family history X sex interaction.||||.89
91745722|NCT04925076|183385009|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,93)=6.72||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of condition.||||.01
91745723|NCT04925076|183385009|SUPERIORITY|||||||0.08|||||||ANOVA|F(1,93)=3.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of family history.||||.08
91745724|NCT04925076|183385009|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.71||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of sex.||||.06
91745725|NCT04925076|183385010|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.14||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.29
91745726|NCT04925076|183385010|SUPERIORITY|||||||0.1|||||||ANOVA|F(1,93)=2.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.10
91745727|NCT04925076|183385010|SUPERIORITY|||||||0.49|||||||ANOVA|F(1,93)=0.47||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history interaction.||||.49
91745728|NCT04925076|183385010|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the family history X sex interaction.||||.99
91745729|NCT04925076|183385010|SUPERIORITY|||||||0.13|||||||ANOVA|F(1,93)=2.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of condition.||||.13
91745730|NCT04925076|183385010|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of family history.||||.82
91745731|NCT04925076|183385010|SUPERIORITY|||||||0.02|||||||ANOVA|F(1,93)=6.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of sex.||||0.02
91745732|NCT04925076|183385011|SUPERIORITY|||||||0.32|||||||ANOVA|F(1,93)=1.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.32
91501796|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.792||||0.9375|TWO_SIDED|95.0|-19.1777|20.7616|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||20.7616|-19.1777|0.9375
91501797|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2037|||<|0.0001|TWO_SIDED|95.0|-74.8113|-35.5961|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.5961|-74.8113|<0.0001
91501798|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.0005|||<|0.0001|TWO_SIDED|95.0|-67.002|-26.9989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.9989|-67.0020|<0.0001
91501799|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6534||||0.0004|TWO_SIDED|95.0|-56.7246|-16.5822|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.5822|-56.7246|0.0004
91501800|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-59.4297|||<|0.0001|TWO_SIDED|95.0|-78.5162|-40.3433|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.3433|-78.5162|<0.0001
91501801|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.2265|||<|0.0001|TWO_SIDED|95.0|-70.8131|-31.6399|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.6399|-70.8131|<0.0001
91501802|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8794||||0.0001|TWO_SIDED|95.0|-60.4726|-21.2862|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-21.2862|-60.4726|0.0001
91531569|NCT02886728|182939606|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.054||0.039|TWO_SIDED|95.0|-0.22|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.22|0.039
91531570|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
91531571|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
91745733|NCT04925076|183385011|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.99
91745734|NCT04925076|183385011|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.83
91745735|NCT04925076|183385011|SUPERIORITY|||||||0.75|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.75
91745736|NCT04925076|183385011|SUPERIORITY|||||||0.62|||||||ANOVA|F(1,93)=0.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of condition.||||.62
91531572|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
91531573|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-7.0|<0.001
91531574|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
91501803|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5197||||0.0102|TWO_SIDED|95.0|5.7096|41.3298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.3298|5.7096|0.0102
91501804|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.7321||||0.0021|TWO_SIDED|95.0|10.3632|45.1011|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||45.1011|10.3632|0.0021
91501805|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7334||||0.5935|TWO_SIDED|95.0|-22.2807|12.814|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.8140|-22.2807|0.5935
91531575|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
91531576|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
91531577|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
91531578|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
91531579|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91531580|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.005|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.005
91531581|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
91501806|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5486||||0.6945|TWO_SIDED|95.0|-14.3397|21.437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.4370|-14.3397|0.6945
91745737|NCT04925076|183385011|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of family history.||||.92
91745738|NCT04925076|183385011|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of sex.||||.39
91745739|NCT04925076|183385012|SUPERIORITY|||||||0.5|||||||ANOVA|F(1,93)=0.45||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.50
91745740|NCT04925076|183385012|SUPERIORITY|||||||0.28|||||||ANOVA|F(1,93)=1.20||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X sex interaction.||||.28
91745741|NCT04925076|183385012|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,93)=0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history interaction.||||.60
91745742|NCT04925076|183385012|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,93)=4.48||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the family history X sex interaction.||||.04
91745743|NCT04925076|183385012|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,93)=1.37||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of condition.||||.25
91745744|NCT04925076|183385012|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of family history.||||.89
91745745|NCT04925076|183385012|SUPERIORITY|||||||0.26|||||||ANOVA|F(1,93)=1.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of sex.||||.26
91745746|NCT04925076|183385013|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.76
91745747|NCT04925076|183385013|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=3.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X sex interaction.||||.09
91745748|NCT04925076|183385013|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history interaction.||||.76
91745749|NCT04925076|183385013|SUPERIORITY|||||||0.77|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the family history X sex interaction.||||.77
91501807|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2936||||0.4177|TWO_SIDED|95.0|-10.4975|25.0847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.0847|-10.4975|0.4177
91745750|NCT04925076|183385013|SUPERIORITY|||||||0.52|||||||ANOVA|F(1,93)=0.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of condition.||||.52
91745751|NCT04925076|183385013|SUPERIORITY|||||||0.93|||||||ANOVA|F(1,93)=0.007||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain hippocampus activation. Here we report the results of the analysis of the main effect of family history.||||.93
91745752|NCT04925076|183385013|SUPERIORITY|||||||0.42|||||||ANOVA|F(1,93)=0.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of sex.||||.42
91745753|NCT04925076|183385014|SUPERIORITY|||||||0.44|||||||ANOVA|F(1,93)=0.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.44
91745754|NCT04925076|183385014|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,93)=1.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X sex interaction.||||.27
91745755|NCT04925076|183385014|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.66||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history interaction.||||.06
91745756|NCT04925076|183385014|SUPERIORITY|||||||0.73|||||||ANOVA|F(1,93)=0.13||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the family history X sex interaction.||||.73
91745757|NCT04925076|183385014|SUPERIORITY|||||||0.047|||||||ANOVA|F(1,93)=4.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of condition.||||.047
91501808|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.2531||||0.0019|TWO_SIDED|95.0|-45.802|-10.7042|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.7042|-45.8020|0.0019
91501809|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9711||||0.0299|TWO_SIDED|95.0|-37.9541|-1.988|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.9880|-37.9541|0.0299
91501810|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2261||||0.0759|TWO_SIDED|95.0|-34.1785|1.7264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7264|-34.1785|0.0759
91745758|NCT04925076|183385014|SUPERIORITY|||||||0.97|||||||ANOVA|F(1,93)=0.001||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of family history.||||.97
91745759|NCT04925076|183385014|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of sex.||||.82
91745760|NCT04925076|183385015|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.57||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||0.45
91745761|NCT04925076|183385015|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,93)=0.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X sex interaction.||||.59
91501811|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4655||||0.0002|TWO_SIDED|95.0|-49.2278|-15.7032|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.7032|-49.2278|0.0002
91501812|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1835||||0.0069|TWO_SIDED|95.0|-41.5832|-6.7838|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.7838|-41.5832|0.0069
91745762|NCT04925076|183385015|SUPERIORITY|||||||0.07|||||||ANOVA|F(1,93)=3.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history interaction.||||.07
91745763|NCT04925076|183385015|SUPERIORITY|||||||0.61|||||||ANOVA|F(1,93)=0.26||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the family history X sex interaction.||||.61
91745764|NCT04925076|183385015|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of condition.||||.82
91745765|NCT04925076|183385015|SUPERIORITY|||||||0.63|||||||ANOVA|F(1,93)=0.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of family history.||||.63
91501813|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4385||||0.0222|TWO_SIDED|95.0|-37.8861|-2.991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.9910|-37.8861|0.0222
91501814|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.589||||0.0002|TWO_SIDED|95.0|12.0126|37.1654|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||37.1654|12.0126|0.0002
91531582|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.063|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.063
91531583|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.6||0.64|TWO_SIDED|95.0|-1.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-1.0|0.64
91501815|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.11|||<|0.0001|TWO_SIDED|95.0|16.4903|41.7298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.7298|16.4903|<0.0001
91501816|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6428||||0.6809|TWO_SIDED|95.0|-10.0309|15.3165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.3165|-10.0309|0.6809
91531584|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91745766|NCT04925076|183385015|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of sex.||||.55
91745767|NCT04925076|183385016|SUPERIORITY|||||||0.57|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.57
91501817|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3215||||0.6067|TWO_SIDED|95.0|-16.0415|9.3985|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.3985|-16.0415|0.6067
91531585|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91531586|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.095|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.095
91745768|NCT04925076|183385016|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,93)=2.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.14
91745769|NCT04925076|183385016|SUPERIORITY|||||||0.69|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.69
91745770|NCT04925076|183385016|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.92||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.34
91745771|NCT04925076|183385016|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.16||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of condition.||||0.29
91745772|NCT04925076|183385016|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,93)=0.004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of family history.||||.95
91501818|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4722||||0.3999|TWO_SIDED|95.0|-7.335|18.2795|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.2795|-7.3350|0.3999
91501819|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.9461||||0.0007|TWO_SIDED|95.0|-34.5327|-9.3596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.3596|-34.5327|0.0007
91501820|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9105|||<|0.0001|TWO_SIDED|95.0|-40.564|-15.257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.2570|-40.5640|<0.0001
91531587|NCT02886728|182939607|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91531588|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91745773|NCT04925076|183385016|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.65||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of sex.||||.11
91745774|NCT01089413|183385038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8579|TWO_SIDED|95.0|0.7|1.54|||Regression, Cox|||||1.54|0.70|0.8579
91745775|NCT01089413|183385039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1555|TWO_SIDED|95.0|0.3|1.21|||Regression, Cox|||||1.21|0.30|0.1555
91745776|NCT01971463|183385044|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank|||Change in oCBF from baseline to post-bolus, ipsilesional hemisphere||||<0.05
91745777|NCT01971463|183385044|SUPERIORITY|Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere|Slope|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.07|||Mixed Models Analysis|||||0.07|0.03|<0.001
91531589|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.002|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.002
91745778|NCT01610557|183385045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.039|TWO_SIDED|95.0|0.07|2.5|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||2.5|0.07|0.039
91745779|NCT01610557|183385046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.0|||<|0.001|TWO_SIDED|95.0|-65.0|-31.0|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||-31|-65|<0.001
91745780|NCT04115748|183385049|SUPERIORITY||Difference in response rates|32.1||||0.048|TWO_SIDED|95.0|2.6|61.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio) DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||61.6|2.6|0.048
91745781|NCT04115748|183385049|SUPERIORITY||Difference in response rates|18.4||||0.23|TWO_SIDED|95.0|-12.4|49.2||The stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.2|-12.4|0.23
91745782|NCT04115748|183385051|SUPERIORITY||Difference in response rates|16.1||||0.17|TWO_SIDED|95.0|-9.7|41.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|0.17
91745783|NCT04115748|183385051|SUPERIORITY||Difference in response rates|11.7||||0.27|TWO_SIDED|95.0|-13.3|36.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||36.6|-13.3|0.27
91745784|NCT04115748|183385051|SUPERIORITY||Difference in response rates|10.5||||0.42|TWO_SIDED|95.0|-20.4|41.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.5|-20.4|0.42
91501821|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1168||||0.0036|TWO_SIDED|95.0|-31.8907|-6.3428|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.3428|-31.8907|0.0036
91501822|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4672|||<|0.0001|TWO_SIDED|95.0|-38.8298|-14.1046|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.1046|-38.8298|<0.0001
91501823|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4315|||<|0.0001|TWO_SIDED|95.0|-44.925|-19.938|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.9380|-44.9250|<0.0001
91745785|NCT04115748|183385051|SUPERIORITY||Difference in response rates|15.8||||0.26|TWO_SIDED|95.0|-16.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.6|-16.0|0.26
91745786|NCT04115748|183385051|SUPERIORITY||Difference in response rates|28.7||||0.062|TWO_SIDED|95.0|-5.0|62.3||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||62.3|-5.0|0.062
91745787|NCT04115748|183385051|SUPERIORITY||Difference in response rates|31.6||||0.047|TWO_SIDED|95.0|-1.5|64.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||64.6|-1.5|0.047
91745788|NCT04115748|183385051|SUPERIORITY||Difference in response rates|7.8||||0.58|TWO_SIDED|95.0|-24.6|40.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.2|-24.6|0.58
91745789|NCT04115748|183385051|SUPERIORITY||Difference in response rates|16.8||||0.27|TWO_SIDED|95.0|-16.2|49.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.9|-16.2|0.27
91745790|NCT04115748|183385052|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
91745791|NCT04115748|183385052|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
91745792|NCT04115748|183385052|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
91745793|NCT04115748|183385052|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-29.6|8.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||8.5|-29.6|
91745794|NCT04115748|183385052|SUPERIORITY||Difference in response rates|5.8|||||TWO_SIDED|95.0|-17.2|28.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.9|-17.2|
91745795|NCT04115748|183385052|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||19.5|-19.5|
91745796|NCT04115748|183385052|SUPERIORITY||Difference in response rates|5.6|||||TWO_SIDED|95.0|-10.3|21.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.4|-10.3|
91745797|NCT04115748|183385052|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-8.4|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||29.5|-8.4|
91745798|NCT04115748|183385058|SUPERIORITY||Difference in response rates|16.1|||||TWO_SIDED|95.0|-9.7|41.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|
91745799|NCT04115748|183385058|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-16.5|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||28.8|-16.5|
91745800|NCT04115748|183385058|SUPERIORITY||Difference in response rates|23.9|||||TWO_SIDED|95.0|-8.8|56.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||56.6|-8.8|
91745801|NCT04115748|183385058|SUPERIORITY||Difference in response rates|27.1|||||TWO_SIDED|95.0|-5.2|59.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||59.4|-5.2|
91745802|NCT04115748|183385059|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.1|5.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.1|-5.1|
91745803|NCT04115748|183385059|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
91501824|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.6378||||0.0003|TWO_SIDED|95.0|-36.2802|-10.9954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.9954|-36.2802|0.0003
91501825|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6675||||0.9728|TWO_SIDED|95.0|-39.708|41.043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.0430|-39.7080|0.9728
91501826|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.7977||||0.0246|TWO_SIDED|95.0|6.1059|79.4894|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||79.4894|6.1059|0.0246
91501827|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5411||||0.7068|TWO_SIDED|95.0|-33.785|48.8672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||48.8672|-33.7850|0.7068
91501828|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7069||||0.5492|TWO_SIDED|95.0|-26.0358|47.4496|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||47.4496|-26.0358|0.5492
91501829|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1248||||0.5899|TWO_SIDED|95.0|-31.3098|53.5595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||53.5595|-31.3098|0.5899
91531590|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
91531591|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
91531592|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
91745804|NCT04115748|183385059|SUPERIORITY||Difference in response rates|11.7|||||TWO_SIDED|95.0|-13.3|36.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||36.6|-13.3|
91531593|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
91531594|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-3.0|<0.001
91745805|NCT04115748|183385059|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-16.4|27.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.4|-16.4|
91745806|NCT04115748|183385060|SUPERIORITY||Difference in response rates|15.8||||0.2|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||45.2|-13.6|0.20
91501830|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8736||||0.6998|TWO_SIDED|95.0|-29.8691|43.6163|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||43.6163|-29.8691|0.6998
91501831|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0394||||0.6187|TWO_SIDED|95.0|-31.4818|51.5606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||51.5606|-31.4818|0.6187
91501832|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4573||||0.5863|TWO_SIDED|95.0|-29.0355|49.9502|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||49.9502|-29.0355|0.5863
91745807|NCT04115748|183385060|SUPERIORITY||Difference in response rates|-5.0||||0.6|TWO_SIDED|95.0|-27.8|17.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.8|-27.8|0.60
91501833|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.2566||||0.0832|TWO_SIDED|95.0|-75.608|5.0948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.0948|-75.6080|0.0832
91531595|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91531596|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
91745808|NCT04115748|183385060|SUPERIORITY||Difference in response rates|42.6||||0.008|TWO_SIDED|95.0|11.5|73.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||73.8|11.5|0.008
91745809|NCT04115748|183385060|SUPERIORITY||Difference in response rates|17.8||||0.17|TWO_SIDED|95.0|-12.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||47.6|-12.0|0.17
91745810|NCT04115748|183385060|SUPERIORITY||Difference in response rates|42.1||||0.011|TWO_SIDED|95.0|8.1|76.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||76.2|8.1|0.011
91501834|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.0907||||0.0827|TWO_SIDED|95.0|-68.7519|4.5704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.5704|-68.7519|0.0827
91501835|NCT00975481|182874479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.6728||||0.1386|TWO_SIDED|95.0|-74.5352|11.1895|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1895|-74.5352|0.1386
91531597|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
91501836|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3637||||0.1691|TWO_SIDED|95.0|-0.1566|0.884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8840|-0.1566|0.1691
91501837|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8444||||0.0017|TWO_SIDED|95.0|0.3238|1.365|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3650|0.3238|0.0017
91745811|NCT04115748|183385060|SUPERIORITY||Difference in response rates|5.3||||0.69|TWO_SIDED|95.0|-30.1|40.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||40.6|-30.1|0.69
91745812|NCT04115748|183385060|SUPERIORITY||Difference in response rates|35.7||||0.033|TWO_SIDED|95.0|0.9|70.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||70.4|0.9|0.033
91745813|NCT04115748|183385060|SUPERIORITY||Difference in response rates|21.1||||0.19|TWO_SIDED|95.0|-15.2|57.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|0.19
91745814|NCT04115748|183385060|SUPERIORITY||Difference in response rates|43.9||||0.007|TWO_SIDED|95.0|12.4|75.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|0.007
91501838|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2093||||0.4305|TWO_SIDED|95.0|-0.3141|0.7327|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7327|-0.3141|0.4305
91501839|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1206||||0.6517|TWO_SIDED|95.0|-0.4064|0.6476|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.6476|-0.4064|0.6517
91501840|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0374||||0.8892|TWO_SIDED|95.0|-0.5666|0.4919|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.4919|-0.5666|0.8892
91745815|NCT04115748|183385060|SUPERIORITY||Difference in response rates|7.6||||0.63|TWO_SIDED|95.0|-28.8|44.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.1|-28.8|0.63
91745816|NCT04115748|183385061|SUPERIORITY||Difference in response rates|0.0||||0.98|TWO_SIDED|95.0|-19.5|19.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|0.98
91745817|NCT04115748|183385061|SUPERIORITY||Difference in response rates|-5.3||||0.5|TWO_SIDED|95.0|-20.7|10.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|0.50
91745818|NCT04115748|183385061|SUPERIORITY||Difference in response rates|5.5||||0.54|TWO_SIDED|95.0|-16.4|27.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||27.4|-16.4|0.54
91501841|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1544||||0.5576|TWO_SIDED|95.0|-0.6737|0.3649|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.3649|-0.6737|0.5576
91745819|NCT04115748|183385061|SUPERIORITY||Difference in response rates|0.6||||0.92|TWO_SIDED|95.0|-19.0|20.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|0.92
91745820|NCT04115748|183385061|SUPERIORITY||Difference in response rates|21.1||||0.13|TWO_SIDED|95.0|-9.3|51.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.4|-9.3|0.13
91745821|NCT04115748|183385061|SUPERIORITY||Difference in response rates|15.8||||0.22|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.2|-13.6|0.22
91745822|NCT04115748|183385061|SUPERIORITY||Difference in response rates|45.0||||0.007|TWO_SIDED|95.0|12.8|77.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.2|12.8|0.007
91745823|NCT04115748|183385061|SUPERIORITY||Difference in response rates|31.6||||0.039|TWO_SIDED|95.0|0.2|63.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||63.0|0.2|0.039
91745824|NCT04115748|183385061|SUPERIORITY||Difference in response rates|12.8||||0.34|TWO_SIDED|95.0|-18.4|44.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.0|-18.4|0.34
91745825|NCT04115748|183385061|SUPERIORITY||Difference in response rates|32.4||||0.04|TWO_SIDED|95.0|-0.1|64.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||64.9|-0.1|0.040
91745826|NCT04115748|183385062|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-10.0|20.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||20.6|-10.0|
91501842|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2431||||0.3594|TWO_SIDED|95.0|-0.7658|0.2796|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2796|-0.7658|0.3594
91745827|NCT04115748|183385062|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.4|5.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.4|-5.4|
91745828|NCT04115748|183385062|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
91745829|NCT04115748|183385062|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
91745830|NCT04115748|183385062|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-14.0|35.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-14.0|
91745831|NCT04115748|183385062|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-17.1|27.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||27.6|-17.1|
91745832|NCT04115748|183385062|SUPERIORITY||Difference in response rates|27.8|||||TWO_SIDED|95.0|1.7|53.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||53.9|1.7|
91745833|NCT04115748|183385062|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|1.3|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||51.4|1.3|
91745834|NCT04115748|183385062|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-16.3|40.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.8|-16.3|
91745835|NCT04115748|183385062|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-8.2|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||51.4|-8.2|
91745836|NCT04115748|183385070|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-46.3|25.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||25.2|-46.3|
91745837|NCT04115748|183385070|SUPERIORITY||Difference in response rates|-8.8|||||TWO_SIDED|95.0|-45.3|27.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||27.7|-45.3|
91501843|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4011||||0.1355|TWO_SIDED|95.0|-0.9291|0.127|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.1270|-0.9291|0.1355
91501844|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6351||||0.0153|TWO_SIDED|95.0|-1.1466|-0.1236|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.1236|-1.1466|0.0153
91501845|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7238||||0.0065|TWO_SIDED|95.0|-1.2418|-0.2059|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2059|-1.2418|0.0065
91501846|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8818||||0.0011|TWO_SIDED|95.0|-1.4042|-0.3594|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.3594|-1.4042|0.0011
91501847|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1614|||<|0.0001|TWO_SIDED|95.0|-2.9373|-1.3856|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.3856|-2.9373|<0.0001
91501848|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0336|||<|0.0001|TWO_SIDED|95.0|-3.8085|-2.2587|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.2587|-3.8085|<0.0001
91501849|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2791||||0.4804|TWO_SIDED|95.0|-1.0586|0.5004|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.5004|-1.0586|0.4804
91501850|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.9519|TWO_SIDED|95.0|-0.7608|0.8087|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8087|-0.7608|0.9519
91501851|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497||||0.2152|TWO_SIDED|95.0|-1.286|0.2921|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2921|-1.2860|0.2152
91501852|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8824|||<|0.0001|TWO_SIDED|95.0|1.1094|2.6553|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6553|1.1094|<0.0001
91501853|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1854|||<|0.0001|TWO_SIDED|95.0|1.407|2.9638|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.9638|1.4070|<0.0001
91501854|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6645|||<|0.0001|TWO_SIDED|95.0|0.8786|2.4503|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.4503|0.8786|<0.0001
91501855|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7545|||<|0.0001|TWO_SIDED|95.0|1.9912|3.5179|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.5179|1.9912|<0.0001
91501856|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0576|||<|0.0001|TWO_SIDED|95.0|2.2858|3.8294|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.8294|2.2858|<0.0001
91501857|NCT00975481|182874480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5366|||<|0.0001|TWO_SIDED|95.0|1.7578|3.3155|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3155|1.7578|<0.0001
91501858|NCT01895855|182874481|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|90.3|||||ONE_SIDED|95.1|62.7||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||62.7|
91501859|NCT01895855|182874482|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|79.5|||||ONE_SIDED|95.1|49.9||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||49.9|
91501860|NCT01895855|182874483|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0073
91501861|NCT01895855|182874484|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenge 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
91501862|NCT01895855|182874485|SUPERIORITY||Vaccine Efficacy|84.5|||||TWO_SIDED|95.0|67.0|100.0|||||Confidence interval for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||100.0|67.0|
91501863|NCT01895855|182874486|SUPERIORITY||Vaccine Efficacy|50.8|||||TWO_SIDED|95.0|33.6|66.8|||||Confidence interval for protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||66.8|33.6|
91501864|NCT01895855|182874487|SUPERIORITY|||||||0.0025|||||||Fisher Exact|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0025
91501865|NCT01895855|182874488|SUPERIORITY|||||||0.0159|||||||Fisher Exact|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0159
91501866|NCT01895855|182874489|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
91531598|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
91745838|NCT04115748|183385070|SUPERIORITY||Difference in response rates|11.8|||||TWO_SIDED|95.0|-22.1|45.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||45.8|-22.1|
91501867|NCT01895855|182874490|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
91501868|NCT01895855|182874491|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
91501869|NCT01895855|182874492|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
91501870|NCT03559257|182874494|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.92|-2.32|||Mixed Models Analysis|||||-2.32|-3.92|<0.0001
91501871|NCT03559257|182874495|SUPERIORITY||LSMean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.41|-1.72|||Mixed Models Analysis|||||-1.72|-3.41|<0.0001
91501872|NCT03559257|182874496|SUPERIORITY||Odds Ratio (OR)|3.935|||<|0.0001|TWO_SIDED|95.0|2.719|5.693|||pseudo likelihood-based repeated measure|||||5.693|2.719|<0.0001
91501873|NCT03559257|182874497|SUPERIORITY||Odds Ratio (OR)|3.481|||<|0.0001|TWO_SIDED|95.0|2.252|5.381|||Pseudo likelihood-based repeated measure|||||5.381|2.252|<0.0001
91501874|NCT03559257|182874498|SUPERIORITY||LSMean Difference|12.53|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|9.19|15.87|||Mixed Models Analysis|||||15.87|9.19|<0.0001
91745839|NCT04115748|183385070|SUPERIORITY||Difference in response rates|19.4|||||TWO_SIDED|95.0|-15.6|54.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.5|-15.6|
91745840|NCT04115748|183385070|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
91745841|NCT04115748|183385070|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
91745842|NCT04115748|183385070|SUPERIORITY||Difference in response rates|29.8|||||TWO_SIDED|95.0|-6.3|66.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||66.0|-6.3|
91745843|NCT04115748|183385070|SUPERIORITY||Difference in response rates|31.6|||||TWO_SIDED|95.0|-3.8|67.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||67.0|-3.8|
91745844|NCT04115748|183385070|SUPERIORITY||Difference in response rates|5.0|||||TWO_SIDED|95.0|-32.0|42.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.0|-32.0|
91745845|NCT04115748|183385070|SUPERIORITY||Difference in response rates|39.2|||||TWO_SIDED|95.0|6.8|71.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.6|6.8|
91745846|NCT04115748|183385071|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||24.8|-24.8|
91745847|NCT04115748|183385071|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-24.9|26.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.0|-24.9|
91745848|NCT04115748|183385071|SUPERIORITY||Difference in response rates|-4.5|||||TWO_SIDED|95.0|-30.5|21.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||21.5|-30.5|
91745849|NCT04115748|183385071|SUPERIORITY||Difference in response rates|12.8|||||TWO_SIDED|95.0|-18.4|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.0|-18.4|
91501875|NCT03559257|182874499|SUPERIORITY||LSMean Difference|11.51|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|7.14|15.89|||Mixed Models Analysis|||||15.89|7.14|<0.0001
91501876|NCT03559257|182874500|SUPERIORITY||Odds Ratio (OR)|5.878||||0.0001|TWO_SIDED|95.0|2.374|14.554|||Pseudo likelihood-based repeated measure|||||14.554|2.374|0.0001
91501877|NCT03559257|182874501|SUPERIORITY||Odds Ratio (OR)|999.999|||<|0.0001|TWO_SIDED|95.0|548.706|999.999|||Pseudo likelihood-based repeated measure||Estimated value and upper bound are \>999.999|||999.999|548.706|<0.0001
91501878|NCT03559257|182874502|SUPERIORITY||Odds Ratio (OR)|5.012|||<|0.0001|TWO_SIDED|95.0|2.352|10.679|||pseudo likelihood-based repeated measure|||||10.679|2.352|<0.0001
91501879|NCT03559257|182874503|SUPERIORITY||Odds Ratio (OR)|999.99|||<|0.0001|TWO_SIDED|95.0|999.99|999.99|||Pseudo likelihood-based repeated measure||Point estimate, upper limit and lower limit are \>999.99|||999.99|999.99|<0.0001
91501880|NCT03559257|182874504|SUPERIORITY||LSMean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.14|-2.65|||Mixed Models Analysis|||||-2.65|-4.14|<0.0001
91501881|NCT03559257|182874505|SUPERIORITY||LSMean Difference|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.96|-2.29|||Mixed Models Analysis|||||-2.29|-3.96|<0.0001
91501882|NCT03559257|182874506|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91745850|NCT04115748|183385071|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.1|56.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||56.3|-14.1|
91745851|NCT04115748|183385071|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-33.3|33.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||33.3|-33.3|
91745852|NCT04115748|183385071|SUPERIORITY||Difference in response rates|34.5|||||TWO_SIDED|95.0|-0.3|69.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||69.3|-0.3|
91745853|NCT04115748|183385071|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||55.1|-13.0|
91745854|NCT04115748|183385071|SUPERIORITY||Difference in response rates|24.4|||||TWO_SIDED|95.0|-9.7|58.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.6|-9.7|
91745855|NCT04115748|183385071|SUPERIORITY||Difference in response rates|32.6|||||TWO_SIDED|95.0|-1.0|66.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||66.2|-1.0|
91745856|NCT04115748|183385073|SUPERIORITY||Difference in response rates|-15.8|||||TWO_SIDED|95.0|-47.6|16.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||16.0|-47.6|
91745857|NCT04115748|183385073|SUPERIORITY||Difference in response rates|-20.5|||||TWO_SIDED|95.0|-51.3|10.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.4|-51.3|
91745858|NCT04115748|183385073|SUPERIORITY||Difference in response rates|6.6|||||TWO_SIDED|95.0|-26.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.9|-26.8|
91745859|NCT04115748|183385073|SUPERIORITY||Difference in response rates|13.9|||||TWO_SIDED|95.0|-20.8|48.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||48.6|-20.8|
91745860|NCT04115748|183385073|SUPERIORITY||Difference in response rates|15.8|||||TWO_SIDED|95.0|-20.7|52.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||52.3|-20.7|
91745861|NCT04115748|183385073|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-31.0|41.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.6|-31.0|
91745862|NCT04115748|183385073|SUPERIORITY||Difference in response rates|24.3|||||TWO_SIDED|95.0|-12.4|60.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.9|-12.4|
91745863|NCT04115748|183385073|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-15.2|57.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|
91745864|NCT04115748|183385073|SUPERIORITY||Difference in response rates|4.4|||||TWO_SIDED|95.0|-32.3|41.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||41.2|-32.3|
91745865|NCT04115748|183385073|SUPERIORITY||Difference in response rates|23.2|||||TWO_SIDED|95.0|-12.5|58.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.8|-12.5|
91501883|NCT03559257|182874507|SUPERIORITY||LSMean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.58|-0.54|||Mixed Models Analysis|||||-0.54|-1.58|<0.0001
91501884|NCT03559257|182874508|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Activity Impairment.||||<0.0001
91501885|NCT03559257|182874508|SUPERIORITY|||||||0.388|||||||ANCOVA|||Absenteeism.||||0.3880
91501886|NCT03559257|182874508|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Presenteeism.||||0.0004
91531599|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
91745866|NCT04115748|183385074|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|
91745867|NCT04115748|183385074|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-20.7|10.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|
91745868|NCT04115748|183385074|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-18.7|19.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.3|-18.7|
91745869|NCT04115748|183385074|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-19.0|20.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|
91745870|NCT04115748|183385074|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.8|-24.8|
91501887|NCT03559257|182874508|SUPERIORITY|||||||0.0003|||||||ANCOVA|||Work impairment.||||0.0003
91501888|NCT03559257|182874509|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
91501889|NCT03559257|182874510|SUPERIORITY|||||||0.1267|||||||ANCOVA|||||||0.1267
91501890|NCT03559257|182874511|SUPERIORITY|||||||0.163|||||||ANCOVA|||||||0.1630
91501891|NCT03559257|182874512|SUPERIORITY|||||||0.0277|||||||ANCOVA|||||||0.0277
91501892|NCT01387347|182874522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.2596|||||||t-test, 2 sided|||Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level||||0.2596
91501893|NCT01387347|182874522|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||t-test, 2 sided|||Comparison of central corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0075
91501894|NCT01387347|182874522|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||t-test, 2 sided|||Comparison of superior corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0210
91501895|NCT01387347|182874523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.3734|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.||||0.3734
91501896|NCT01387347|182874523|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED||||||t-test, 2 sided|||Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28||||0.0244
91501897|NCT01519960|182874525|OTHER||Odds Ratio (OR)|5.43|||=|0.0043|TWO_SIDED|95.0|1.54|19.2|||Cochran-Mantel-Haenszel|||Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (\<) 5 times (×) upper limit of normal (ULN) versus greater than or equal to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.||19.2|1.54|= 0.0043
91745871|NCT04115748|183385074|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
91501898|NCT01519960|182874525|OTHER||||||=|0.3732|||||||Breslow-Day|||||||= 0.3732
91501899|NCT00951808|182874606|SUPERIORITY_OR_OTHER||optimal threshold level of sPLA2|48.0|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|38.0|58.0|||||The optimal threshold level (TL) was determined to be the same for all analysis groups.|The optimal threshold level (TL), determined via receiver operating characteristic (ROC) curve analysis, maximizes the difference between the true positive rate (TPR) and the false positive rate (FPR). Since there is no corresponding analytic standard deviation (SD) for this value, we computed a robust SD based upon the interquartile range (IQR)/1.35 from a bootstrap sample of optimal TLs.||58|38|
91501900|NCT03194555|182874646|SUPERIORITY||Risk Difference (RD)|-2.17||||0.4267|TWO_SIDED|95.0|-3.67|8.01|||Chi-squared|||||8.01|-3.67|0.4267
91745872|NCT04115748|183385074|SUPERIORITY||Difference in response rates|17.0|||||TWO_SIDED|95.0|-10.1|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||44.0|-10.1|
91745873|NCT04115748|183385074|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|-2.1|54.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.8|-2.1|
91745874|NCT04115748|183385074|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-20.3|33.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.6|-20.3|
91745875|NCT04115748|183385074|SUPERIORITY||Difference in response rates|11.1|||||TWO_SIDED|95.0|-16.6|38.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.7|-16.6|
91745876|NCT04115748|183385076|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-34.8|34.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||34.8|-34.8|
91745877|NCT04115748|183385076|SUPERIORITY||Difference in response rates|-14.9|||||TWO_SIDED|95.0|-47.4|17.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.6|-47.4|
91745878|NCT04115748|183385076|SUPERIORITY||Difference in response rates|27.9|||||TWO_SIDED|95.0|-7.2|63.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||63.0|-7.2|
91745879|NCT04115748|183385076|SUPERIORITY||Difference in response rates|8.9|||||TWO_SIDED|95.0|-26.6|44.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.3|-26.6|
91745880|NCT04115748|183385076|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||55.1|-13.0|
91745881|NCT04115748|183385076|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-47.4|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.3|-47.4|
91745882|NCT04115748|183385076|SUPERIORITY||Difference in response rates|24.9|||||TWO_SIDED|95.0|-11.1|60.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.8|-11.1|
91745883|NCT04115748|183385076|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.9|57.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.0|-14.9|
91745884|NCT04115748|183385076|SUPERIORITY||Difference in response rates|43.9|||||TWO_SIDED|95.0|12.4|75.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|
91745885|NCT04115748|183385076|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-23.4|49.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.1|-23.4|
91745886|NCT04115748|183385078|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-14.8|89.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||89.8|-14.8|
91501901|NCT03194555|182874647|SUPERIORITY||Risk Difference (RD)|2.0||||0.268|TWO_SIDED|95.0|-18.46|66.83|||Chi-squared|||||66.83|-18.46|0.268
91745887|NCT04115748|183385078|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||100.0|-25.4|
91745888|NCT04115748|183385078|SUPERIORITY||Difference in response rates|-25.0|||||TWO_SIDED|95.0|-100.0|51.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.2|-100.0|
91501902|NCT03194555|182874648|SUPERIORITY||Risk Difference (RD)|3.0||||0.0926|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.0926
91501903|NCT03194555|182874649|SUPERIORITY||Risk Difference (RD)|2.0||||0.2894|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.2894
91501904|NCT03194555|182874650|SUPERIORITY||Risk Difference (RD)|-1.83||||0.5724|TWO_SIDED|95.0|-5.1557|8.8157|||Chi-squared|||||8.8157|-5.1557|0.5724
91501905|NCT03194555|182874651|SUPERIORITY||Risk Difference (RD)|-9.84||||0.2998|TWO_SIDED|95.0|-11.15|30.83|||Chi-squared|||||30.83|-11.15|0.2998
91501906|NCT03194555|182874652|SUPERIORITY||Risk Difference (RD)|-11.67||||0.2673|TWO_SIDED||||||Chi-squared|||||||0.2673
91501907|NCT03194555|182874655|SUPERIORITY||Risk Difference (RD)|28.76||||0.3527|TWO_SIDED|95.0|-94.5005|36.9805|||Chi-squared|||||36.9805|-94.5005|0.3527
91501908|NCT03194555|182874656|SUPERIORITY||Risk Difference (RD)|-1.95||||0.5246|TWO_SIDED||||||Chi-squared|||||||0.5246
91501909|NCT03194555|182874658|SUPERIORITY||Risk Difference (RD)|0.34||||0.8649|TWO_SIDED||||||Chi-squared|||||||0.8649
91745889|NCT04115748|183385078|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||77.7|-97.7|
91745890|NCT04115748|183385078|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-73.7|88.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||88.0|-73.7|
91745891|NCT04115748|183385078|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.7|-97.7|
91745892|NCT04115748|183385078|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
91745893|NCT04115748|183385078|SUPERIORITY||Difference in response rates|15.0|||||TWO_SIDED|95.0|-67.9|97.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||97.9|-67.9|
91745894|NCT04115748|183385079|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.2|-29.2|
91745895|NCT04115748|183385079|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||77.6|-37.6|
91745896|NCT04115748|183385079|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||73.8|-23.8|
91745897|NCT04115748|183385079|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||100.0|-25.4|
91745898|NCT04115748|183385079|SUPERIORITY||Difference in response rates|42.9|||||TWO_SIDED|95.0|-13.4|99.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||99.2|-13.4|
91745899|NCT04115748|183385079|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||100.0|-25.4|
91745900|NCT04115748|183385079|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
91745901|NCT04115748|183385079|SUPERIORITY||Difference in response rates|-5.0|||||TWO_SIDED|95.0|-82.5|72.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||72.5|-82.5|
91745902|NCT04115748|183385080|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
91745903|NCT04115748|183385080|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
91745904|NCT04115748|183385080|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||54.2|-29.2|
91745905|NCT04115748|183385080|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
91745906|NCT04115748|183385080|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
91745907|NCT04115748|183385080|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.6|-37.6|
91745908|NCT04115748|183385080|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||73.8|-23.8|
91745909|NCT04115748|183385080|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
91745910|NCT04115748|183385081|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
91745911|NCT04115748|183385081|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
91745912|NCT04115748|183385081|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.8|-18.8|
91745913|NCT04115748|183385081|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
91745914|NCT04115748|183385081|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
91745915|NCT04115748|183385081|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||22.5|-22.5|
91745916|NCT04115748|183385081|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||54.2|-29.2|
91745917|NCT04115748|183385081|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
91745918|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.104||0.94|TWO_SIDED|95.0|-0.22|0.2||P-value was calculated from mixed-effects model for repeated measures (MMRM) including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.20|-0.22|0.94
91501910|NCT01831154|182874659|SUPERIORITY_OR_OTHER|||||||0.512|||||||Chi-squared|Chi-squared value of 1.34 and Cramer's V .190||Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.||||0.512
91501911|NCT01831154|182874660|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
91501912|NCT01831154|182874662|SUPERIORITY_OR_OTHER|||||||0.132|||||||ANOVA|||||||0.132
91745919|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.105||0.81|TWO_SIDED|95.0|-0.18|0.24||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.24|-0.18|0.81
91745920|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.112||0.13|TWO_SIDED|95.0|-0.39|0.05||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.05|-0.39|0.13
91745921|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.113||0.073|TWO_SIDED|95.0|-0.43|0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.02|-0.43|0.073
91745922|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.124||0.083|TWO_SIDED|95.0|-0.46|0.03||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.03|-0.46|0.083
91745923|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124||0.28|TWO_SIDED|95.0|-0.38|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.11|-0.38|0.28
91745924|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.038|TWO_SIDED|95.0|-0.54|-0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||-0.02|-0.54|0.038
91501913|NCT01831154|182874663|SUPERIORITY_OR_OTHER|||||||0.908||||||A one way ANOVA was used to determine if participants in the tight glycemic group had shorter intensive care unit (ICU) length of stay (LOS) than participants in the other interventional groups.|ANOVA|||||||0.908
91501914|NCT03255382|182874684|OTHER||Adjusted percentage difference|73.3|||<|0.001|TWO_SIDED|95.0|61.3|85.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy \[yes/no\]).||85.3|61.3|< 0.001
91501915|NCT03255382|182874685|OTHER||Adjusted percentage difference|46.8|||<|0.001|TWO_SIDED|95.0|32.8|60.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.8|32.8|< 0.001
91745925|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.25|TWO_SIDED|95.0|-0.41|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||0.11|-0.41|0.25
91501916|NCT03255382|182874686|OTHER||Adjusted percentage difference|63.4|||<|0.001|TWO_SIDED|95.0|50.2|76.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||76.6|50.2|< 0.001
91745926|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.41|TWO_SIDED|95.0|-0.39|0.16||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.16|-0.39|0.41
91745927|NCT04115748|183385085|SUPERIORITY||LS Mean Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.26|TWO_SIDED|95.0|-0.43|0.12||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.12|-0.43|0.26
91501917|NCT03255382|182874687|OTHER||Adjusted percentage difference|53.1|||<|0.001|TWO_SIDED|95.0|40.4|65.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||65.7|40.4|< 0.001
91501918|NCT03255382|182874688|OTHER||Adjusted percentage difference|39.6|||<|0.001|TWO_SIDED|95.0|27.3|51.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.9|27.3|< 0.001
91501919|NCT03255382|182874689|OTHER||Adjusted percentage difference|36.3|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||48.5|24.1|< 0.001
91501920|NCT03255382|182874690|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|33.7|59.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.0|33.7|< 0.001
91501921|NCT03255382|182874691|OTHER||Adjusted percentage difference|9.9||||0.047|TWO_SIDED|95.0|0.1|19.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||19.7|0.1|0.047
91501922|NCT03255382|182874692|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
91501923|NCT03255382|182874693|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.9|53.3|< 0.001
91745928|NCT04115748|183385086|SUPERIORITY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|2.26||0.14|TWO_SIDED|95.0|-1.1|7.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.9|-1.1|0.14
91745929|NCT04115748|183385086|SUPERIORITY||LS Mean Treatment Difference|3.1|STANDARD_ERROR_OF_MEAN|2.3||0.18|TWO_SIDED|95.0|-1.5|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.7|-1.5|0.18
91745930|NCT04115748|183385086|SUPERIORITY||LS Mean Treatment Difference|3.7|STANDARD_ERROR_OF_MEAN|2.53||0.15|TWO_SIDED|95.0|-1.4|8.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.7|-1.4|0.15
91745931|NCT04115748|183385086|SUPERIORITY||LS Mean Treatment Difference|4.8|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.3|9.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||9.9|-0.3|0.062
91745932|NCT04115748|183385088|SUPERIORITY||LS Mean Treatment Difference|5.3|STANDARD_ERROR_OF_MEAN|1.68||0.003|TWO_SIDED|95.0|1.9|8.6||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.6|1.9|0.003
91745933|NCT04115748|183385088|SUPERIORITY||LS Mean Treatment Difference|4.9|STANDARD_ERROR_OF_MEAN|1.71||0.006|TWO_SIDED|95.0|1.5|8.3||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.3|1.5|0.006
91745934|NCT04115748|183385088|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|2.09||0.076|TWO_SIDED|95.0|-0.4|8.0||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.0|-0.4|0.076
91745935|NCT04115748|183385088|SUPERIORITY||LS Mean Treatment Difference|3.5|STANDARD_ERROR_OF_MEAN|2.1||0.1|TWO_SIDED|95.0|-0.7|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||7.7|-0.7|0.10
91745936|NCT02752633|183385089|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.||||<.05
91745937|NCT06053541|183385090|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.24
91745938|NCT06053541|183385091|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.37
91745939|NCT06053541|183385092|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.03
91745940|NCT06053541|183385093|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Beds in the general practice and Pulmonology: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.11
91745941|NCT06053541|183385093|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Beds in Adults ICU: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||<0.01
91745942|NCT06053541|183385094|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.01
91745943|NCT06053541|183385095|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.07
91745944|NCT00152477|183385096|SUPERIORITY||Difference of response rate|6.4|||=|0.384|TWO_SIDED|95.0|-7.7|20.5||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \<5.|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.384
91745945|NCT00152477|183385096|SUPERIORITY||Difference of response rate|6.4|||=|0.409||95.0|-7.7|20.5||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.409
91745946|NCT00152477|183385096|SUPERIORITY||Difference of response rate|2.6|||=|0.744|TWO_SIDED|95.0|-13.5|18.8||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||18.8|-13.5|=0.744
91501924|NCT03255382|182874694|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
91501925|NCT03255382|182874695|OTHER||Adjusted percentage difference|56.5|||<|0.001|TWO_SIDED|95.0|43.0|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.0|< 0.001
91501926|NCT03255382|182874696|OTHER||Adjusted percentage difference|64.8|||<|0.001|TWO_SIDED|95.0|52.5|77.2|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||77.2|52.5|< 0.001
91745947|NCT00152477|183385096|SUPERIORITY||Difference of response rate|2.6|||=|0.783|TWO_SIDED|95.0|-13.5|18.8||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||18.8|-13.5|=0.783
91745948|NCT00152477|183385096|SUPERIORITY||Difference of response rate|10.2|||=|0.234|TWO_SIDED|95.0|-6.8|27.2||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||27.2|-6.8|=0.234
91745949|NCT00152477|183385096|SUPERIORITY||Difference of response rate|10.2|||=|0.228|TWO_SIDED|95.0|-6.8|27.2||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||27.2|-6.8|=0.228
91745950|NCT00123162|183385102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.9|7.6|||ANCOVA|adjusted for baseline pain intensity (Visual Analog Scale (VAS) score).||With 26 subjects per treatment group and an assumed within-group standard deviation of 7 units, the study was designed to have 90% statistical power for a two-sided, 0.05 significance level test to detect a difference of 6.5 units in TOPAR4 between a single dose of 100 mg of sildenafil and placebo. However, we anticipated subject drop-out as high as 15%; therefore, we planned to recruit 31 subjects per treatment group.||7.6|2.9|<0.001
91745951|NCT00123162|183385103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.6|||<|0.001|TWO_SIDED|95.0|-58.3|-26.8|||Mixed Models Analysis||Comparison of the VAS score at hour 4 (Sildenafil Citrate - Placebo)|||-26.8|-58.3|<.001
91745952|NCT01467037|183385179|SUPERIORITY_OR_OTHER||Adjusted OR|0.088|||||TWO_SIDED|95.0|0.02|0.384|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.384|0.020|
91745953|NCT01467037|183385179|SUPERIORITY_OR_OTHER||Adjusted OR|0.075|||||TWO_SIDED|95.0|0.018|0.307|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.307|0.018|
91745954|NCT01194089|183385188|SUPERIORITY_OR_OTHER|||||||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.||||0.828
91745955|NCT01194089|183385188|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.||||0.752
91745956|NCT01194089|183385189|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||Comparison between the arms for antiemetic medication use in the PACU.||||0.002
91501927|NCT03255382|182874697|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
91745957|NCT01194089|183385190|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score on admission.||||0.354
91745958|NCT01194089|183385190|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 30 minutes.||||0.492
91501928|NCT03255382|182874698|OTHER||Adjusted percentage difference|36.6|||<|0.001|TWO_SIDED|95.0|23.8|49.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||49.3|23.8|< 0.001
91501929|NCT03255382|182874699|OTHER||Adjusted percentage difference|56.6|||<|0.001|TWO_SIDED|95.0|43.2|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.2|< 0.001
91745959|NCT01194089|183385190|SUPERIORITY_OR_OTHER|||||||0.809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 60 minutes.||||0.809
91745960|NCT01194089|183385190|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at discharge.||||0.381
91501930|NCT03255382|182874700|OTHER||Adjusted percentage difference|64.9|||<|0.001|TWO_SIDED|95.0|51.5|78.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||78.3|51.5|< 0.001
91745961|NCT03070171|183385191|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-tz of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.46909|||||TWO_SIDED|90.0|101.44605|115.97833|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.97833|101.44605|
91745962|NCT03070171|183385192|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.9587|||||TWO_SIDED|90.0|101.78627|116.63654|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||116.63654|101.78627|
91745963|NCT03070171|183385193|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.61507|||||TWO_SIDED|90.0|100.61938|115.09714|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.09714|100.61938|
91501931|NCT03255382|182874701|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.8|53.3|< 0.001
91501932|NCT03255382|182874702|OTHER||Adjusted percentage difference|0.0||||0.991|TWO_SIDED|95.0|-2.0|2.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||2.1|-2.0|0.991
91501933|NCT03255382|182874703|OTHER||Adjusted percentage difference|3.3||||0.323|TWO_SIDED|95.0|-3.2|9.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||9.8|-3.2|0.323
91501934|NCT03255382|182874704|OTHER||Adjusted percentage difference|21.5|||<|0.001|TWO_SIDED|95.0|10.4|32.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||32.6|10.4|< 0.001
91501935|NCT03255382|182874705|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.5|20.7|< 0.001
91501936|NCT03255382|182874706|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
91501937|NCT03255382|182874707|OTHER||Adjusted percentage difference|44.7|||<|0.001|TWO_SIDED|95.0|30.9|58.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||58.5|30.9|< 0.001
91501938|NCT03255382|182874708|OTHER||Least Squares Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|0.825|<|0.001|TWO_SIDED|95.0|-8.82|-5.56|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-5.56|-8.82|< 0.001
91501939|NCT03255382|182874709|OTHER||Least Squares Mean Difference|-9.58|STANDARD_ERROR_OF_MEAN|0.936|<|0.001|TWO_SIDED|95.0|-11.43|-7.72|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.72|-11.43|< 0.001
91501940|NCT03255382|182874710|OTHER||Least Squares Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|0.972|<|0.001|TWO_SIDED|95.0|-10.72|-6.87|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.87|-10.72|< 0.001
91501941|NCT03255382|182874711|OTHER||Least Squares Mean Difference|-7.78|STANDARD_ERROR_OF_MEAN|0.958|<|0.001|TWO_SIDED|95.0|-9.68|-5.88|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.88|-9.68|< 0.001
91501942|NCT03255382|182874712|OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.101|<|0.001|TWO_SIDED|95.0|-10.07|-5.71|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.71|-10.07|< 0.001
91501943|NCT03255382|182874713|OTHER||Least Squares Mean Difference|-8.39|STANDARD_ERROR_OF_MEAN|1.175|<|0.001|TWO_SIDED|95.0|-10.71|-6.06|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.06|-10.71|< 0.001
91501944|NCT03255382|182874714|OTHER||Adjusted percentage difference|29.7|||<|0.001|TWO_SIDED|95.0|17.1|42.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||42.4|17.1|< 0.001
91745964|NCT03070171|183385194|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|106.69566|||||TWO_SIDED|90.0|99.50139|114.4101|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.41010|99.50139|
91745965|NCT03070171|183385195|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.83324|||||TWO_SIDED|90.0|101.25584|114.8379|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.83790|101.25584|
91501945|NCT03255382|182874715|OTHER||Adjusted percentage difference|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||80.0|53.4|< 0.001
91501946|NCT03255382|182874716|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.8|42.7|< 0.001
91745966|NCT03070171|183385196|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.43158|||||TWO_SIDED|90.0|101.87254|115.41292|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.41292|101.87254|
91745967|NCT01500252|183385227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
91745968|NCT01500252|183385228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||95.0|||||t-test, 2 sided|||||||0.83
91745969|NCT01500252|183385230|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
91745970|NCT01500252|183385231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
91745971|NCT01500252|183385232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
91745972|NCT01500252|183385233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
91501947|NCT03255382|182874717|OTHER||Adjusted percentage difference|59.9|||<|0.001|TWO_SIDED|95.0|46.3|73.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||73.6|46.3|< 0.001
91501948|NCT03255382|182874718|OTHER||Adjusted percentage difference|44.9|||<|0.001|TWO_SIDED|95.0|30.8|59.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.1|30.8|< 0.001
91501949|NCT03255382|182874719|OTHER||Adjusted percentage difference|55.0|||<|0.001|TWO_SIDED|95.0|41.2|68.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||68.8|41.2|< 0.001
91501950|NCT03255382|182874720|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
91501951|NCT03255382|182874721|OTHER||Adjusted percentage difference|8.4||||0.048|TWO_SIDED|95.0|0.1|16.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||16.7|0.1|0.048
91745973|NCT01500252|183385234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
91745974|NCT01500252|183385235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
91745975|NCT01500252|183385236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Chi-squared|||||||0.31
91745976|NCT01106651|183385265|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.708|-0.436|||ANCOVA|||||-0.436|-0.708|<0.001
91745977|NCT01106651|183385265|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.841|-0.566|||ANCOVA|||||-0.566|-0.841|<0.001
91745978|NCT01106651|183385266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001||95.0|1.93|4.56|||Regression, Logistic|||||4.56|1.93|<0.001
91745979|NCT01106651|183385266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001||95.0|2.89|6.95|||Regression, Logistic|||||6.95|2.89|<0.001
91745980|NCT01106651|183385267|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|3.147|<|0.001|TWO_SIDED|95.0|-31.68|-19.32|||ANCOVA|||||-19.32|-31.68|<0.001
91745981|NCT01106651|183385267|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-27.7|STANDARD_ERROR_OF_MEAN|3.179|<|0.001|TWO_SIDED|95.0|-33.97|-21.49|||ANCOVA|||||-21.49|-33.97|<0.001
91501952|NCT03255382|182874722|OTHER||Adjusted percentage difference|18.3||||0.001|TWO_SIDED|95.0|7.1|29.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||29.5|7.1|0.001
91531600|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|<0.001
91531601|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.12|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-1.0|0.12
91745982|NCT01106651|183385268|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||ANCOVA|||||-1.7|-2.8|<0.001
91745983|NCT01106651|183385268|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.4|||ANCOVA|||||-2.4|-3.5|<0.001
91745984|NCT01106651|183385269|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.379|<|0.001|TWO_SIDED|95.0|-2.339|-0.842|||ANCOVA|||||-0.842|-2.339|<0.001
91745985|NCT01106651|183385269|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.371|<|0.001|TWO_SIDED|95.0|-2.833|-1.368|||ANCOVA|||||-1.368|-2.833|<0.001
91745986|NCT01106651|183385270|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.305|<|0.001|TWO_SIDED|95.0|-1.633|-0.428|||ANCOVA|||Region percent total fat||-0.428|-1.633|<0.001
91745987|NCT01106651|183385270|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.772|-0.587|||ANCOVA|||Region percent total fat||-0.587|-1.772|<0.001
91745988|NCT01106651|183385271|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.316||0.001|TWO_SIDED|95.0|-1.677|-0.43|||ANCOVA|||||-0.430|-1.677|0.001
91745989|NCT01106651|183385271|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.311|<|0.001|TWO_SIDED|95.0|-1.812|-0.584|||ANCOVA|||||-0.584|-1.812|<0.001
91745990|NCT01106651|183385272|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.63|STANDARD_ERROR_OF_MEAN|1.134|<|0.001|TWO_SIDED|95.0|-6.854|-2.401|||ANCOVA|||||-2.401|-6.854|<0.001
91745991|NCT01106651|183385272|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.147|<|0.001|TWO_SIDED|95.0|-10.14|-5.641|||ANCOVA|||||-5.641|-10.14|<0.001
91501953|NCT03255382|182874723|OTHER||Adjusted percentage difference|33.0|||<|0.001|TWO_SIDED|95.0|20.2|45.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.9|20.2|< 0.001
91745992|NCT01106651|183385273|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.7||0.194|TWO_SIDED|95.0|-12.1|2.5|||ANCOVA|||||2.5|-12.1|0.194
91501954|NCT03255382|182874724|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
91501955|NCT03255382|182874725|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|32.6|60.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.1|32.6|< 0.001
91501956|NCT03255382|182874726|OTHER||Adjusted percentage difference|19.8||||0.001|TWO_SIDED|95.0|7.6|31.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||31.9|7.6|0.001
91745993|NCT01106651|183385273|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.846|TWO_SIDED|95.0|-6.6|8.1|||ANCOVA|||||8.1|-6.6|0.846
91745994|NCT01106651|183385274|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.6|7.9|||ANCOVA|||||7.9|2.6|<0.001
91745995|NCT01106651|183385274|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.0|7.4|||ANCOVA|||||7.4|2.0|<0.001
91745996|NCT01106651|183385275|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||||0.8|-0.4|
91745997|NCT01106651|183385275|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||||0.3|-0.9|
91745998|NCT01106651|183385276|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||||0.4|-0.9|
91745999|NCT01106651|183385276|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.0|0.3|||ANCOVA|||||0.3|-1.0|
91746000|NCT01106651|183385277|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.0|||ANCOVA|||||1.0|-0.3|
91746001|NCT01106651|183385277|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|
91746002|NCT01106651|183385278|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||||-0.0|-0.8|
91746003|NCT01106651|183385278|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||||-0.1|-0.9|
91746004|NCT02466425|183385279|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-13.0|-6.8|||Mixed-effects model for repeated measure||Between treatment groups|||-6.8|-13.0|<0.001
91746005|NCT00712725|183385285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
91746006|NCT00712725|183385286|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
91746007|NCT00712725|183385287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
91746008|NCT00712725|183385288|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
91746009|NCT00712725|183385289|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||0.007
91746010|NCT00712725|183385290|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
91746011|NCT01901289|183385291|OTHER||Cumulative Probability|0.927|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.881|0.956|||||The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|||0.956|0.881|
91501957|NCT03255382|182874727|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|25.0|51.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.5|25.0|< 0.001
91746012|NCT00889603|183385292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.92|||||TWO_SIDED|95.0|1.65|2.2|||||Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.|||2.20|1.65|
91746013|NCT00889603|183385293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|0.75|1.08|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.|||1.08|0.75|
91746014|NCT00889603|183385293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.32|1.8|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||1.80|1.32|
91746015|NCT00889603|183385293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.69|2.25|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||2.25|1.69|
91746016|NCT01606176|183385364|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.39||||0.332|TWO_SIDED|95.0|-1.18|0.4|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.40|-1.18|0.332
91746017|NCT01606176|183385365|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-29.55||||0.002|TWO_SIDED|95.0|-48.08|-11.02|||ANOVA|||The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.||-11.02|-48.08|0.002
91501958|NCT03255382|182874728|OTHER||Least Squares Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.0|-4.5|< 0.001
91746018|NCT01606176|183385366|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.34||||0.052|TWO_SIDED|95.0|-0.68|0.0|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.00|-0.68|0.052
91746019|NCT01606176|183385367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.79||||0.3|TWO_SIDED|95.0|-8.14|2.56|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||2.56|-8.14|0.300
91501959|NCT03255382|182874729|OTHER||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-5.1|-2.7|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.7|-5.1|< 0.001
91501960|NCT03255382|182874730|OTHER||Least Squares Mean Difference|1.146|||<|0.001|TWO_SIDED|95.0|0.764|1.528|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.528|0.764|< 0.001
91746020|NCT01606176|183385368|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.66||||0.233|TWO_SIDED|95.0|-4.42|1.1|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||1.10|-4.42|0.233
91746021|NCT01606176|183385369|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.28||||0.387|TWO_SIDED|95.0|-0.36|0.91|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.91|-0.36|0.387
91746022|NCT01606176|183385370|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.47||||1|TWO_SIDED|95.0|-21.56|18.51|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||18.51|-21.56|1.000
91746023|NCT01606176|183385371|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.86||||0.128|TWO_SIDED|95.0|-1.97|0.26|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.26|-1.97|0.128
91746024|NCT01606176|183385372|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-31.77||||0.009|TWO_SIDED|95.0|-55.07|-8.47|||ANOVA|||The proportions were compared between treatment groups using ANOVA with treatment as a factor.||-8.47|-55.07|0.009
91746025|NCT01606176|183385373|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.184|TWO_SIDED|95.0|-0.8|0.16|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.16|-0.80|0.184
91746026|NCT01606176|183385374|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.18||||0.134|TWO_SIDED|95.0|-12.05|1.68|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||1.68|-12.05|0.134
91746027|NCT01606176|183385375|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.77||||0.031|TWO_SIDED|95.0|-7.17|-0.36|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||-0.36|-7.17|0.031
91746028|NCT01606176|183385376|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.04||||0.915|TWO_SIDED|95.0|-0.79|0.88|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.88|-0.79|0.915
91746029|NCT01606176|183385377|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.95||||1|TWO_SIDED|95.0|-21.85|27.47|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||27.47|-21.85|1.00
91746030|NCT01179217|183385395|SUPERIORITY_OR_OTHER_LEGACY||Wilcoxon rank-sum test|0.5||||0.0052|TWO_SIDED|||||"1. The primary analysis was analyzed using a CMH analysis of the number of SCCs using modified ridit scores.~2. P-value (controlling for region and HU use)~3. The null hypothesis of the final analysis was performed at the 0.045 significance level."|Cochran-Mantel-Haenszel|||||||0.0052
91746031|NCT01179217|183385396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
91746032|NCT01179217|183385397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0888|||||||Cochran-Mantel-Haenszel|||||||0.0888
91746033|NCT01818258|183385415|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event. Null hypothesis of no difference between cohorts.||||0.40
91501961|NCT03255382|182874731|OTHER||Least Squares Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.936|1.704|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.704|0.936|< 0.001
91501962|NCT03255382|182874732|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-3.6|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.6|< 0.001
91501963|NCT03255382|182874733|OTHER||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|-4.3|-1.6|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.6|-4.3|< 0.001
91501964|NCT03255382|182874734|OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.307||0.352|TWO_SIDED|95.0|-0.9|0.32|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.32|-0.90|0.352
91501965|NCT03255382|182874735|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.296||0.315|TWO_SIDED|95.0|-0.88|0.29|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.29|-0.88|0.315
91501966|NCT03255382|182874736|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-2.7|-6.9|< 0.001
91501967|NCT03255382|182874737|OTHER||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-12.6|-6.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.1|-12.6|< 0.001
91531602|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.019|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.019
91746034|NCT01818258|183385416|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event related to study treatment. Null hypothesis of no difference between cohorts.||||>0.999
91746035|NCT01818258|183385417|SUPERIORITY||Geometric Mean Ratio|0.77||||0.49|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.6|0.4|0.49
91746036|NCT01818258|183385417|SUPERIORITY||Geometric Mean Ratio|0.64||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
91746037|NCT01818258|183385417|SUPERIORITY||Geometric Mean Ratio|0.81||||0.63|TWO_SIDED|95.0|0.3|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|0.3|0.63
91746038|NCT01818258|183385418|SUPERIORITY||Geometric Mean Ratio|1.06||||0.89|TWO_SIDED|95.0|0.5|2.3|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV Clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.5|0.89
91746039|NCT01818258|183385418|SUPERIORITY||Geometric Mean Ratio|1.42||||0.37|TWO_SIDED|95.0|0.7|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.7|0.37
91746040|NCT01818258|183385418|SUPERIORITY||Geometric Mean Ratio|1.23||||0.63|TWO_SIDED|95.0|0.5|2.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.9|0.5|0.63
91746041|NCT01818258|183385419|SUPERIORITY||Geometric Mean Ratio|0.76||||0.42|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.42
91746042|NCT01818258|183385419|SUPERIORITY||Geometric Mean Ratio|0.58||||0.11|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.11
91746043|NCT01818258|183385419|SUPERIORITY||Geometric Mean Ratio|0.77||||0.44|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.44
91746044|NCT01818258|183385420|SUPERIORITY||Geometric Mean Ratio|1.07||||0.84|TWO_SIDED|95.0|0.5|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.5|0.84
91746045|NCT01818258|183385420|SUPERIORITY||Geometric Mean Ratio|1.54||||0.21|TWO_SIDED|95.0|0.8|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.8|0.21
91501968|NCT03255382|182874738|OTHER||Least Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-13.2|-7.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.2|-13.2|< 0.001
91501969|NCT03255382|182874739|OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-12.8|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.8|< 0.001
91501970|NCT03255382|182874740|OTHER||Least Squares Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-12.4|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.4|< 0.001
91746046|NCT01818258|183385420|SUPERIORITY||Geometric Mean Ratio|1.29||||0.44|TWO_SIDED|95.0|0.7|2.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.5|0.7|0.44
91746047|NCT01818258|183385421|SUPERIORITY||Geometric Mean Ratio|0.77||||0.27|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.2|0.5|0.27
91746048|NCT01818258|183385421|SUPERIORITY||Geometric Mean Ratio|0.6||||0.047|TWO_SIDED|95.0|0.4|1.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.0|0.4|0.047
91501971|NCT03255382|182874741|OTHER||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-12.9|-7.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.1|-12.9|< 0.001
91501972|NCT03255382|182874742|OTHER||Least Squares Mean Difference|4.49|STANDARD_ERROR_OF_MEAN|1.385||0.002|TWO_SIDED|95.0|1.74|7.23|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.23|1.74|0.002
91501973|NCT03255382|182874743|OTHER||Least Squares Mean Difference|4.63|STANDARD_ERROR_OF_MEAN|1.322|<|0.001|TWO_SIDED|95.0|2.01|7.25|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.25|2.01|< 0.001
91501974|NCT03255382|182874744|OTHER||Least Squares Mean Difference|6.66|STANDARD_ERROR_OF_MEAN|1.787|<|0.001|TWO_SIDED|95.0|3.11|10.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||10.20|3.11|< 0.001
91501975|NCT03255382|182874745|OTHER||Least Squares Mean Difference|7.85|STANDARD_ERROR_OF_MEAN|1.784|<|0.001|TWO_SIDED|95.0|4.31|11.38|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||11.38|4.31|< 0.001
91746049|NCT01818258|183385421|SUPERIORITY||Geometric Mean Ratio|1.09||||0.76|TWO_SIDED|95.0|0.6|1.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.9|0.6|0.76
91746050|NCT01818258|183385422|SUPERIORITY||Geometric Mean Ratio|0.0||||0.89|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||0.5|-0.4|0.89
91746051|NCT01818258|183385422|SUPERIORITY||Geometric Mean Ratio|1.4||||0.18|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.8|0.18
91746052|NCT01818258|183385422|SUPERIORITY||Geometric Mean Ratio|0.85||||0.53|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.5|0.53
91746053|NCT01818258|183385423|SUPERIORITY||Geometric Mean Ratio|1.27||||0.39|TWO_SIDED|95.0|0.7|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.7|0.39
91501976|NCT03255382|182874746|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.7|-1.2|< 0.001
91501977|NCT03255382|182874747|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.8|-1.3|< 0.001
91501978|NCT03255382|182874748|OTHER||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.2|-0.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.9|-3.2|< 0.001
91501979|NCT03255382|182874749|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.5|< 0.001
91501980|NCT03255382|182874750|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-4.3|-1.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.9|-4.3|< 0.001
91501981|NCT03255382|182874751|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-4.4|-1.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.8|-4.4|< 0.001
91746054|NCT01818258|183385423|SUPERIORITY||Geometric Mean Ratio|1.37||||0.43|TWO_SIDED|95.0|0.6|3.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||3.0|0.6|0.43
91746055|NCT01818258|183385423|SUPERIORITY||Geometric Mean Ratio|1.52||||0.003|TWO_SIDED|95.0|1.2|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|1.2|0.003
91501982|NCT03255382|182874752|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|23.6|53.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||53.1|23.6|< 0.001
91746056|NCT01818258|183385424|SUPERIORITY||Geometric Mean Ratio|0.6||||0.09|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.090
91746057|NCT01818258|183385424|SUPERIORITY||Geometric Mean Ratio|0.6||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
91746058|NCT01818258|183385424|SUPERIORITY||Geometric Mean Ratio|0.64||||0.0003|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||0.8|0.5|0.0003
91746059|NCT01818258|183385425|SUPERIORITY||Odds Ratio (OR)|0.54||||0.17|TWO_SIDED|95.0|0.22|1.29|||Mixed Models Analysis||Odds Ratio (SAM/non-SAM) for Lopinavir Ctrough \>= 1 ug/mL through 48 weeks|Odds ratio (SAM/non-SAM) of Ctrough \>=1 ug/mL from entry through 48 weeks from repeated measures mixed model, with the null hypothesis that the odds ratio is equal to zero (no difference between cohorts in odds of Ctrough \>=1 ug/mL).||1.29|0.22|0.17
91746060|NCT01818258|183385426|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.003|TWO_SIDED|95.0|-3.9|-0.9|||t-test, 2 sided||Severe Malnutrition Cohort - Normal Nutrition/Mild Malnutrition for Week 1 Free Fraction (%) of LPV|Week 1 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-0.9|-3.9|0.003
91746061|NCT01818258|183385426|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.011|TWO_SIDED|95.0|-6.6|-1.1|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 12 Free Fraction (%) of LPV|Week 12 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-1.1|-6.6|0.011
91746062|NCT01818258|183385426|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-2.4|4.4|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 24 Free Fraction (%) of LPV|Week 24 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||4.4|-2.4|0.46
91746063|NCT01818258|183385427|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.15|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 12. Null hypothesis of no difference between cohorts.||1.7|-0.3|0.15
91746064|NCT01818258|183385427|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 24. Null hypothesis of no difference between cohorts.||1.8|-0.4|0.20
91746065|NCT01818258|183385427|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.13|TWO_SIDED|95.0|-0.2|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 36. Null hypothesis of no difference between cohorts.||1.8|-0.2|0.13
91746066|NCT01818258|183385427|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.089|TWO_SIDED|95.0|-0.1|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 48. Null hypothesis of no difference between cohorts.||1.8|-0.1|0.089
91746067|NCT01818258|183385428|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Baseline Comparison, with null hypothesis of no difference between cohorts.||||>0.999
91746068|NCT01818258|183385428|SUPERIORITY|||||||0.15|||||||Fisher Exact|||Week 12 Comparison, with null hypothesis of no difference between cohorts.||||0.15
91746069|NCT01818258|183385428|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 24 Comparison, with null hypothesis of no difference between cohorts.||||0.065
91746070|NCT01818258|183385428|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 48 Comparison, with null hypothesis of no difference between cohorts.||||0.065
91746071|NCT01818258|183385429|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.89|TWO_SIDED|95.0|-3.9|4.4|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 12. Null hypothesis of no difference between cohorts.||4.4|-3.9|0.89
91501983|NCT03255382|182874753|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.9|42.7|< 0.001
91746072|NCT01818258|183385429|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.31|TWO_SIDED|95.0|-2.5|7.6|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 24. Null hypothesis of no difference between cohorts.||7.6|-2.5|0.31
91746073|NCT01818258|183385429|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.18|TWO_SIDED|95.0|-1.5|7.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 36. Null hypothesis of no difference between cohorts.||7.8|-1.5|0.18
91746074|NCT01818258|183385429|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.018|TWO_SIDED|95.0|1.1|11.0|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference between cohorts of change in CD4 percent from baseline to week 48. Null hypothesis of no difference between cohorts.||11.0|1.1|0.018
91746075|NCT01818258|183385430|SUPERIORITY||Mean|2.34|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 24 equal to 0||2.91|1.77|<0.0001
91746076|NCT01818258|183385430|SUPERIORITY||Mean|2.73|||<|0.0001|TWO_SIDED|95.0|2.09|3.37|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 48 equal to 0||3.37|2.09|<0.0001
91746077|NCT01818258|183385431|SUPERIORITY||Mean|2.63|||<|0.0001|TWO_SIDED|95.0|1.96|3.28|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 24 equal to 0||3.28|1.96|<0.0001
91746078|NCT01818258|183385431|SUPERIORITY||Mean|3.53|||<|0.0001|TWO_SIDED|95.0|2.83|4.24|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 48 equal to 0||4.24|2.83|<0.0001
91746079|NCT00349921|183385437|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of \>30% reduction in visual analog scale pain 120 min after intrathecal injection||||>0.05
91746080|NCT00810771|183385443|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|||||||0.873
91746081|NCT00810771|183385444|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Chi-squared|||||||0.671
91746082|NCT00810771|183385445|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
91746083|NCT00810771|183385446|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Chi-squared|||||||0.186
91746084|NCT00810771|183385447|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Chi-squared|||||||0.576
91746085|NCT00810771|183385448|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
91746086|NCT00107900|183385462|SUPERIORITY_OR_OTHER|||||||0.238|TWO_SIDED||||||Fisher Exact|||||||0.238
91746087|NCT03724981|183385469|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
91746088|NCT03724981|183385470|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
91746089|NCT02791191|183385484|SUPERIORITY|||||||0.418|||||||ANCOVA|||||||0.418
91746090|NCT02791191|183385484|SUPERIORITY|||||||0.231|||||||ANCOVA|||||||0.231
91746091|NCT02791191|183385485|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
91746092|NCT02791191|183385485|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
91746093|NCT02791191|183385485|SUPERIORITY|||||||0.404|||||||Fisher Exact|||||||0.404
91746094|NCT02791191|183385485|SUPERIORITY|||||||1|||||||Fisher Exact|||Cortical Superficial Siderous||||1.000
91746095|NCT02791191|183385485|SUPERIORITY|Lacunar Infarct||||||1|||||||Fisher Exact|||||||1.000
91746096|NCT02791191|183385485|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Lacunar Infarct||||0.457
91501984|NCT03255382|182874754|OTHER||Least Squares Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-9.6|-5.1|||ANCOVA|||P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.||-5.1|-9.6|< 0.001
91501985|NCT03255382|182874755|OTHER||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-9.7|-5.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.5|-9.7|< 0.001
91746097|NCT02791191|183385485|SUPERIORITY|||||||1|||||||Fisher Exact|||Other Infarct||||1.000
91746098|NCT02791191|183385485|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Other Infarct||||0.457
91746099|NCT02791191|183385486|SUPERIORITY|||||||1|||||||Fisher Exact|||Vasogenic Edema||||1.000
91746100|NCT02791191|183385486|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Vasogenic Edema||||0.457
91746101|NCT02791191|183385486|SUPERIORITY|||||||0.703|||||||Fisher Exact|||Increase in Microhemorrhage||||0.703
91746102|NCT02791191|183385486|SUPERIORITY|||||||1|||||||Fisher Exact|||Increase in Microhemorrhage||||1.000
91746103|NCT02791191|183385487|SUPERIORITY|||||||0.452|||||||Fisher Exact|||Treatment Emergent Suicidal Ideation||||0.452
91746104|NCT02791191|183385487|SUPERIORITY|||||||0.279||||||TE Suicidal Ideation|Fisher Exact|||||||0.279
91746105|NCT02791191|183385487|SUPERIORITY|||||||0.293|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.293
91746106|NCT02791191|183385487|SUPERIORITY|||||||0.486|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.486
91746107|NCT02791191|183385489|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta||||<.001
91746108|NCT02791191|183385489|SUPERIORITY|Amyloid Beta|||||<|0.001|||||||ANCOVA|||||||<.001
91746109|NCT02791191|183385489|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
91746110|NCT02791191|183385489|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
91746111|NCT02791191|183385489|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
91746112|NCT02791191|183385489|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
91746113|NCT02791191|183385490|SUPERIORITY|||||||0.97|||||||Mixed Model Repeated Measures|||||||0.970
91746114|NCT02791191|183385490|SUPERIORITY|||||||0.586|||||||Mixed Model Repeated Meausres|||||||0.586
91746115|NCT02791191|183385491|SUPERIORITY|||||||0.088|||||||ANCOVA|||||||0.088
91746116|NCT02791191|183385491|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.150
91746117|NCT02791191|183385492|SUPERIORITY|||||||0.153|||||||ANCOVA|||||||0.153
91746118|NCT02791191|183385492|SUPERIORITY|||||||0.176|||||||ANCOVA|||||||0.176
91746119|NCT02370537|183385494|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-square means (LSmeans) for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% Confidence Intervals (CIs) by degree of pancreatic exocrine function using level of FEC were exponentiated.|Geometric least-squares (GLS) Mean Ratio|0.75|||||TWO_SIDED|90.0|0.52|1.1|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.10|0.52|
91746120|NCT02370537|183385494|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean ratio|0.48|||||TWO_SIDED|90.0|0.32|0.72|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.72|0.32|
91501986|NCT03255382|182874756|OTHER||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|-9.0|-4.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-4.1|-9.0|< 0.001
91501987|NCT03255382|182874757|OTHER||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-11.1|-5.0|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.0|-11.1|< 0.001
91501988|NCT03255382|182874758|OTHER||Least Squares Mean Difference|0.087|STANDARD_ERROR_OF_MEAN|0.0215|<|0.001|TWO_SIDED|95.0|0.045|0.13|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.130|0.045|< 0.001
91746121|NCT02370537|183385494|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.44|0.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.82|0.44|
91746122|NCT02370537|183385495|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.28|||||TWO_SIDED|90.0|0.84|1.93|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.93|0.84|
91746123|NCT02370537|183385495|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.51|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.51|
91746124|NCT02370537|183385495|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.29|||||TWO_SIDED|90.0|0.92|1.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.82|0.92|
91746125|NCT02370537|183385496|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.63|1.28|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.28|0.63|
91746126|NCT02370537|183385496|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.58|||||TWO_SIDED|90.0|0.39|0.85|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.85|0.39|
91746127|NCT02370537|183385496|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.75|||||TWO_SIDED|90.0|0.55|1.0|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.00|0.55|
91501989|NCT03255382|182874759|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0186||0.002|TWO_SIDED|95.0|0.022|0.096|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.096|0.022|0.002
91501990|NCT03255382|182874760|OTHER||Least Squares Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|9.4|20.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||20.5|9.4|< 0.001
91501991|NCT03255382|182874761|OTHER||Least Squares Mean Difference|16.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|11.4|22.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||22.2|11.4|< 0.001
91501992|NCT03255382|182874762|OTHER||Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-16.6|-6.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-6.2|-16.6|< 0.001
91501993|NCT03255382|182874763|OTHER||Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.1|-8.4|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-8.4|-19.1|< 0.001
91746128|NCT02370537|183385497|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.52|||||TWO_SIDED|90.0|0.37|0.73|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.73|0.37|
91501994|NCT03255382|182874764|OTHER||Least Squares Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-24.8|-9.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-9.8|-24.8|< 0.001
91501995|NCT03255382|182874765|OTHER||Least Squares Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-28.8|-14.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-14.2|-28.8|< 0.001
91531603|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
91531604|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.032|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.032
91531605|NCT02886728|182939608|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|<0.001
91531606|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
91746129|NCT02370537|183385497|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.46|||||TWO_SIDED|90.0|0.32|0.67|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.67|0.32|
91746130|NCT02370537|183385497|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.4|0.7|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.70|0.40|
91501996|NCT00735787|182874777|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.||||0.014
91501997|NCT00624052|182874810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.47|1.66|||Cochran-Mantel-Haenszel|||||1.66|0.47|
91501998|NCT00624052|182874810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||||95.0|0.14|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.14|
91501999|NCT00624052|182874810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||||95.0|0.12|0.48|||Cochran-Mantel-Haenszel|||||0.48|0.12|
91502000|NCT00624052|182874810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||||95.0|0.17|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.17|
91502001|NCT00624052|182874810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.15|0.49|||Cochran-Mantel-Haenszel|||||0.49|0.15|
91502002|NCT00624052|182874810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||||95.0|0.42|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.42|
91502003|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED||||||Regression, Logistic|||Treatment response and participant age||||0.0164
91502004|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0200
91502005|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.0867
91502006|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Regression, Logistic|||Remission and participant age||||0.0001
91502007|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.0734|TWO_SIDED||||||Regression, Logistic|||Remission and positive tuberculosis screening at Visit 0||||0.0734
91502008|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Regression, Logistic|||Remission and male gender||||0.0438
91502009|NCT01474876|182874837|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI score at Visit 0||||0.5030
91502010|NCT01474876|182874846|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0576
91531607|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
91746131|NCT02370537|183385498|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-squares LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.77|1.36|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.36|0.77|
91502011|NCT01474876|182874846|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.1739
91502012|NCT01474876|182874846|SUPERIORITY_OR_OTHER|||||||0.0733|TWO_SIDED||||||Regression, Logistic|||Remission and Psoriasis at Visit 0||||0.0733
91502013|NCT01474876|182874846|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI at Visit 0||||0.5000
91502014|NCT04035161|182874865|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.15|0.16||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.16|-0.15|
91502015|NCT04035161|182874865|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.43|-0.05||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||-0.05|-0.43|
91502016|NCT04035161|182874865|SUPERIORITY||Mean Difference (Final Values)|1.82|||||TWO_SIDED|95.0|1.66|1.97||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||1.97|1.66|
91502017|NCT04035161|182874865|SUPERIORITY||Mean Difference (Final Values)|2.38|||||TWO_SIDED|95.0|2.19|2.56||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.56|2.19|
91502018|NCT04035161|182874868|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.08|0.23||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.23|-0.08|
91746132|NCT02370537|183385498|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.67|
91502019|NCT04035161|182874868|SUPERIORITY||Mean Difference (Final Values)|1.99|||||TWO_SIDED|95.0|1.84|2.15||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.15|1.84|
91502020|NCT03479307|182874904|SUPERIORITY||Mean Difference (Final Values)|-0.71|||<|0.0001|TWO_SIDED|95.0|-1.013|-0.407|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).||-0.407|-1.013|< 0.0001
91502021|NCT03479307|182874904|SUPERIORITY||Mean Difference (Final Values)|-1.167|||<|0.0001|TWO_SIDED|95.0|-1.439|-0.895|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.895|-1.439|< 0.0001
91502022|NCT03479307|182874904|SUPERIORITY||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.413|-0.868|||ANCOVA|||Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.868|-1.413|< 0.0001
91502023|NCT03479307|182874904|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|0.009||||0.0007|ONE_SIDED|97.5||0.235|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test).||0.235||0.0007
91746133|NCT02370537|183385498|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.11|||||TWO_SIDED|90.0|0.88|1.4|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.40|0.88|
91746134|NCT02370537|183385499|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean|0.68|||||TWO_SIDED|90.0|0.49|0.92|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.92|0.49|
91746135|NCT02370537|183385499|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.42|0.84|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.84|0.42|
91746136|NCT02370537|183385499|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.7|||||TWO_SIDED|90.0|0.54|0.9|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.90|0.54|
91502024|NCT03479307|182874904|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.077||||0.0002|ONE_SIDED|97.5||0.175|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test).||0.175||0.0002
91502025|NCT03479307|182874904|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.159|||<|0.0001|ONE_SIDED|97.5||0.101|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test).||0.101||< 0.0001
91502026|NCT02113956|182874910|SUPERIORITY||Incident Rate Ratio (IRR)|1.42|||||TWO_SIDED|95.0|0.79|2.57|||Poisson regression||Adjusted for age and baseline number of condomless sex acts|||2.57|0.79|
91502027|NCT02113956|182874911|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.12|0.36|
91502028|NCT02113956|182874912|SUPERIORITY||Incident Rate Ratio|0.95|||||TWO_SIDED|95.0|0.45|2.02|||Poisson||||Adjusted for age and baseline number of condomless sex acts|2.02|0.45|
91502029|NCT02113956|182874913|SUPERIORITY||Incident Rate Ratio (IRR)|0.62|||||TWO_SIDED|95.0|0.12|3.18|||Poisson||||Adjusted for age and baseline number of condomless sex acts|3.18|0.12|
91502030|NCT02113956|182874914|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.23|0.997|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|0.997|0.23|
91746137|NCT00678535|183385508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.3158||95.0|0.92|1.292|||Stratified log rank||Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).||1.292|0.920|0.3158
91746138|NCT00678535|183385509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9547||95.0|0.866|1.165|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo-) adjuvant(radio) chemotherapy, α=5%)||1.165|0.866|0.9547
91746139|NCT00678535|183385510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0435||||0.7696||95.0|0.7844|1.3882|||Cochran-Mantel-Haenszel|||The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, two-sided with α=5%).||1.3882|0.7844|0.7696
91746140|NCT03817463|183385569|OTHER||Adjusted Hazard Ratio|0.7|||<|0.005|TWO_SIDED|95.0|0.6|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-(broad+specific)||0.83|0.60|<0.005
91746141|NCT03817463|183385569|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.57|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline||HHF-(broad + specific).||0.78|0.57|<0.005
91746142|NCT03817463|183385570|OTHER||Ajusted hazard ratio|0.75|||<|0.005|TWO_SIDED|95.0|0.69|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.81|0.69|<0.005
91746143|NCT03817463|183385570|OTHER||Ajusted hazard ratio|0.78|||<|0.005|TWO_SIDED|95.0|0.69|0.88|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.88|0.69|<0.005
91746144|NCT03817463|183385571|OTHER||Adjusted Hazard Ratio|0.68|||<|0.005|TWO_SIDED|95.0|0.56|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.83|0.56|<0.005
91746145|NCT03817463|183385571|OTHER||Adjusted Hazard Ratio|0.64|||<|0.005|TWO_SIDED|95.0|0.51|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.81|0.51|<0.005
91746146|NCT03817463|183385572|OTHER||Adjusted Hazard Ratio|0.55|||<|0.005|TWO_SIDED|95.0|0.48|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.63|0.48|<0.005
91746147|NCT03817463|183385572|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.54|0.65|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.65|0.54|<0.005
91746148|NCT03817463|183385573|OTHER||Adjusted Hazard Ratio|0.65|||<|0.05|TWO_SIDED|95.0|0.56|0.76|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.76|0.56|<0.05
91746149|NCT03817463|183385573|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.61|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.72|0.61|<0.005
91746150|NCT03817463|183385574|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.64|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.82|0.64|<0.005
91746151|NCT03817463|183385574|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.66|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.78|0.66|<0.005
91746152|NCT03817463|183385575|OTHER||Adjusted Hazard Ratio|1.02||||0.816|TWO_SIDED|95.0|0.88|1.18|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.18|0.88|0.816
91502031|NCT02113956|182874915|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.38|2.53|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.53|0.38|
91502032|NCT02113956|182874916|SUPERIORITY||Odds Ratio (OR)|3.42|||||TWO_SIDED|95.0|1.65|7.09|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.09|1.65|
91746153|NCT03817463|183385575|OTHER||Adjusted Hazard Ratio|0.87||||0.013|TWO_SIDED|95.0|0.78|0.97|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.97|0.78|0.013
91746154|NCT03817463|183385576|OTHER||Adjusted Hazard Ratio|0.82|||<|0.011|TWO_SIDED|95.0|0.71|0.96|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.96|0.71|<0.011
91502033|NCT02113956|182874917|SUPERIORITY||Incident Risk Ratio (IRR)|0.58|||||TWO_SIDED|95.0|0.22|1.5|||Poisson||||Adjusted for age and baseline number of condomless sex acts|1.5|0.22|
91502034|NCT02113956|182874918|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.6|2.09|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.09|0.6|
91746155|NCT03817463|183385576|OTHER||Adjusted Hazard Ratio|0.84||||0.064|TWO_SIDED|95.0|0.69|1.01|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.01|0.69|0.064
91746156|NCT03817463|183385577|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.42|0.84|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.84|0.42|<0.005
91746157|NCT03817463|183385577|OTHER||Adjusted Hazard Ratio|0.6|||<|0.005|TWO_SIDED|95.0|0.49|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.72|0.49|<0.005
91502035|NCT02113956|182874919|SUPERIORITY||Incident Rate Ratio (IRR)|0.6|||||TWO_SIDED|95.0|0.22|1.68|||||||Adjusted for age and baseline number of condomless sex acts|1.68|0.22|
91502036|NCT02113956|182874920|SUPERIORITY||Incident Rate Ratio (IRR)|1.1|||||TWO_SIDED|95.0|0.01|92.03|||||||Adjusted for age and baseline number of condomless sex acts|92.03|0.01|
91531608|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-10.0|<0.001
91746158|NCT03817463|183385578|OTHER||Adjusted Hazard Ratio|0.54|||<|0.005|TWO_SIDED|95.0|0.46|0.64|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.64|0.46|<0.005
91746159|NCT03817463|183385578|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.47|0.66|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.66|0.47|<0.005
91746160|NCT03817463|183385579|OTHER||Adjusted Hazard Ratio|0.95||||0.545|TWO_SIDED|95.0|0.81|1.11|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.11|0.81|0.545
91746161|NCT03817463|183385579|OTHER||Adjusted Hazard Ratio|0.91||||0.036|TWO_SIDED|95.0|0.83|0.99|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.99|0.83|0.036
91746162|NCT03817463|183385580|OTHER||Adjusted Hazard Ratio|0.93||||0.353|TWO_SIDED|95.0|0.79|1.09|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.09|0.79|0.353
91746163|NCT03817463|183385580|OTHER||Adjusted Hazard Ratio|0.9||||0.197|TWO_SIDED|95.0|0.78|1.05|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.05|0.78|0.197
91746164|NCT03817463|183385581|OTHER||Adjusted Hazard Ratio|0.43|||<|0.005|TWO_SIDED|95.0|0.3|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.63|0.30|<0.005
91746165|NCT03817463|183385581|OTHER||Adjusted Hazard Ratio|0.27|||<|0.005|TWO_SIDED|95.0|0.16|0.44|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.44|0.16|<0.005
91502037|NCT02113956|182874921|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.46|1.88|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.88|0.46|
91746166|NCT03817463|183385582|OTHER||Adjusted Hazard Ratio|1.05||||0.535|TWO_SIDED|95.0|0.89|1.25|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.25|0.89|0.535
91746167|NCT03817463|183385582|OTHER||Adjusted Hazard Ratio|0.98||||0.85|TWO_SIDED|95.0|0.84|1.15|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.15|0.84|0.850
91746168|NCT03817463|183385583|OTHER||Adjusted Hazard Ratio|1.03||||0.828|TWO_SIDED|95.0|0.81|1.31|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.31|0.81|0.828
91502038|NCT02113956|182874922|SUPERIORITY||Odds Ratio (OR)|3.4|||||TWO_SIDED|95.0|0.88|16.95|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|16.95|0.88|
91502039|NCT02113956|182874923|SUPERIORITY||Odds Ratio (OR)|3.39|||||TWO_SIDED|95.0|1.52|7.58|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.58|1.52|
91502040|NCT02467465|182874925|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
91502041|NCT02467465|182874926|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
91502042|NCT02467465|182874927|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||||||0.466
91502043|NCT02467465|182874929|SUPERIORITY|||||||0.737|||||||Wilcoxon (Mann-Whitney)|||||||0.737
91502044|NCT02467465|182874930|SUPERIORITY|||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
91502045|NCT02467465|182874931|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
91502046|NCT02467465|182874933|SUPERIORITY|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
91746169|NCT03817463|183385583|OTHER||Adjusted Hazard Ratio|1.01||||0.944|TWO_SIDED|95.0|0.72|1.42|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.42|0.72|0.944
91746170|NCT03817463|183385584|OTHER||Adjusted Hazard Ratio|0.94||||0.642|TWO_SIDED|95.0|0.73|1.22|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.22|0.73|0.642
91746171|NCT03817463|183385584|OTHER||Adjusted Hazard Ratio|0.89||||0.417|TWO_SIDED|95.0|0.66|1.19|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.19|0.66|0.417
91746172|NCT03817463|183385585|OTHER||Adjusted Hazard Ratio|0.89||||0.091|TWO_SIDED|95.0|0.77|1.02|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.02|0.77|0.091
91502047|NCT02467465|182874934|SUPERIORITY|||||||0.425|||||||Wilcoxon (Mann-Whitney)|||||||0.425
91502048|NCT02467465|182874935|SUPERIORITY|||||||0.487|||||||Wilcoxon (Mann-Whitney)|||||||0.487
91502049|NCT02467465|182874937|SUPERIORITY|||||||0.651|||||||t-test, 1 sided|||||||0.651
91502050|NCT02467465|182874938|SUPERIORITY|||||||0.387|||||||t-test, 1 sided|||||||0.387
91502051|NCT02467465|182874939|SUPERIORITY|||||||0.755|||||||t-test, 1 sided|||||||0.755
91502052|NCT02467465|182874941|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||0.032
91502053|NCT02467465|182874942|SUPERIORITY|||||||0.058|||||||t-test, 1 sided|||||||0.058
91502054|NCT02467465|182874943|SUPERIORITY|||||||0.279|||||||t-test, 1 sided|||||||0.279
91502055|NCT01499563|182874944|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.4||0.017|TWO_SIDED|95.0|-11.1|-0.4|||Mixed Effects model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||-0.4|-11.1|0.017
91502056|NCT01499563|182874944|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.708|TWO_SIDED|95.0|-6.3|4.5|||Mixed Effects Model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||4.5|-6.3|0.708
91502057|NCT03658538|182874948|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.025|TWO_SIDED|95.0|-8.2|-0.5||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||-0.5|-8.2|0.025
91502058|NCT03658538|182874949|SUPERIORITY|||||||0.061||||||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||||0.061
91502059|NCT00319644|182874958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.26||95.0|||||Chi-squared|||The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.||||0.26
91502060|NCT00597012|182874960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4||||0.26|TWO_SIDED|95.0|-1.8|6.5|||ANCOVA|||"The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned."||6.5|-1.8|0.26
91502061|NCT00597012|182874961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9||||0.16|TWO_SIDED|95.0|-1.2|7.0|||ANCOVA|||||7.0|-1.2|0.16
91746173|NCT03817463|183385586|OTHER||Adjusted Hazard Ratio|1.97|||<|0.005|TWO_SIDED|95.0|1.28|3.03|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||3.03|1.28|<0.005
91746174|NCT03817463|183385587|OTHER||Adjusted Hazard Ratio|0.95||||0.654|TWO_SIDED|95.0|0.75|1.2|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.20|0.75|0.654
91502062|NCT00597012|182874962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1||||0.68|TWO_SIDED|95.0|-4.4|6.6|||ANCOVA|||||6.6|-4.4|0.68
91502063|NCT04916600|182874972|SUPERIORITY||Difference in percentages|22.0||||0.043|TWO_SIDED|||||The threshold for statistical significance was p = .05|Chi-squared||Treatment difference = Active device \>=24 hour group - remainder of participants (Active \<24 hr, Sham \>=24 hr, and Sham \<24 hr groups)|||||.043
91502064|NCT04916600|182874973|SUPERIORITY||Mean Difference (Net)|-3.4||||0.032|TWO_SIDED|||||The threshold for statistical significance was p = .05|t-test, 2 sided|df=101||||||.032
91502065|NCT01245270|182874977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"For the incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed.~Values obtained following the control and extract capsules were compared by paired t-tests."|t-test, 2 sided|||||||0.003
91502066|NCT01245270|182874978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||95.0||||For incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed. Values obtained following the control and extract capsules were compared by paired t-tests.|t-test, 2 sided|||||||0.028
91502067|NCT01959542|182874981|OTHER|Pearson's product-moment correlation|Pearson's product-moment correlation|-0.53||||0.09|TWO_SIDED|95.0|-86.0|0.1|||Pearson's product-moment correlation|||||0.10|-086|0.09
91502068|NCT01959542|182874982|OTHER||Pearson's product-moment correlation|-0.62||||0.03|TWO_SIDED|95.0|-0.62|-0.15|||Pearson's product-moment correlation|Pearson's product moment correlation||||-0.15|-0.62|0.03
91502069|NCT02584504|182875039|SUPERIORITY||Least Square (LS) Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-46.5|-32.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis|Threshold for significance at 0.025 level.|Alirocumab 150 mg Q4W vs. Placebo|Alirocumab 150 mg Q4W group was compared to placebo group using an appropriate contrast statement.||-32.4|-46.5|<0.0001
91502070|NCT02584504|182875039|SUPERIORITY||LS Mean Difference|-65.8|||<|0.0001|TWO_SIDED|97.5|-72.9|-58.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q2W group was compared to placebo group using an appropriate contrast statement.||-58.7|-72.9|<0.0001
91502071|NCT02584504|182875039|OTHER|Statistical test was not planned because this comparison was for a descriptive purpose.|LS Mean Difference|-26.3|||||TWO_SIDED|95.0|-32.5|-20.0|||||Alirocumab 150 mg Q4W group vs Alirocumab 150 mg Q2W|Alirocumab 150 mg Q4W group was compared to Alirocumab 150 mg Q2W group using an appropriate contrast statement.||-20.0|-32.5|
91746175|NCT03817463|183385588|OTHER||Adjusted Hazard Ratio|0.78||||0.233|TWO_SIDED|95.0|0.52|1.17|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.17|0.52|0.233
91502072|NCT02584504|182875040|SUPERIORITY||LS Mean Difference|-40.6|||<|0.0001|TWO_SIDED|97.5|-47.4|-33.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Hierarchical procedure for comparisons of Alirocumab 150 mg Q4W versus Placebo Q2W and Alirocumab 150 mg Q2W versus Placebo Q2W were processed separately.||-33.8|-47.4|<0.0001
91502073|NCT02584504|182875040|SUPERIORITY||LS Mean Difference|-67.4|||<|0.0001|TWO_SIDED|97.5|-74.2|-60.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.5|-74.2|<0.0001
91502074|NCT02584504|182875041|SUPERIORITY||LS Mean Difference|-50.5|||<|0.0001|TWO_SIDED|97.5|-56.6|-44.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-44.5|-56.6|<0.0001
91502075|NCT02584504|182875041|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|97.5|-72.3|-60.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.1|-72.3|<0.0001
91502076|NCT02584504|182875042|SUPERIORITY||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|97.5|-57.4|-45.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.4|-57.4|<0.0001
91502077|NCT02584504|182875042|SUPERIORITY||LS Mean Difference|-67.3|||<|0.0001|TWO_SIDED|97.5|-73.3|-61.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-61.3|-73.3|<0.0001
91502078|NCT02584504|182875043|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|97.5|-32.5|-19.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-19.9|-32.5|<0.0001
91502079|NCT02584504|182875043|SUPERIORITY||LS Mean Difference|-51.9|||<|0.0001|TWO_SIDED|97.5|-58.3|-45.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.5|-58.3|<0.0001
91502080|NCT02584504|182875044|SUPERIORITY||LS Mean Difference|-27.2|||<|0.0001|TWO_SIDED|97.5|-33.5|-20.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-20.9|-33.5|<0.0001
91746176|NCT03817463|183385589|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.38|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.82|0.38|<0.005
91746177|NCT03817463|183385590|OTHER||Rate Ratio|0.74|||||TWO_SIDED|95.0|0.69|0.8|||||Poisson regression model was used.|Emergency room visits - Finland||0.80|0.69|
91746178|NCT03817463|183385590|OTHER||Rate Ratio|0.9|||||TWO_SIDED|95.0|0.59|1.38|||||Poisson regression model was used.|Emergency room visits - Japan||1.38|0.59|
91746179|NCT03817463|183385590|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.0|||||Poisson regression model was used.|Emergency room visits - South Korea||1.00|0.82|
91746180|NCT03817463|183385590|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Poisson regression model was used.|Emergency room visit - Spain||0.87|0.59|
91746181|NCT03817463|183385590|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.87|1.01|||||Poisson regression model was used.|Emergency room visit - Sweden||1.01|0.87|
91746182|NCT03817463|183385590|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Poisson regression model was used.|Emergency room visit - Taiwan||0.93|0.80|
91746183|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.75|0.85|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Finland||0.85|0.75|
91746184|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.84|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Japan||0.84|0.68|
91502081|NCT02584504|182875044|SUPERIORITY||LS Mean Difference|-53.4|||<|0.0001|TWO_SIDED|97.5|-59.7|-47.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-47.1|-59.7|<0.0001
91502082|NCT02584504|182875045|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|97.5|-37.7|-25.0||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-25.0|-37.7|<0.0001
91502083|NCT02584504|182875045|SUPERIORITY||LS Mean Difference|-56.2|||<|0.0001|TWO_SIDED|97.5|-62.5|-49.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-49.8|-62.5|<0.0001
91502084|NCT02584504|182875046|SUPERIORITY||LS Mean Difference|-32.4|||<|0.0001|TWO_SIDED|97.5|-38.6|-26.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-26.3|-38.6|<0.0001
91502085|NCT02584504|182875046|SUPERIORITY||LS Mean Difference|-57.6|||<|0.0001|TWO_SIDED|97.5|-63.8|-51.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-51.4|-63.8|<0.0001
91502086|NCT02584504|182875047|SUPERIORITY||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|97.5|-27.4|-17.6||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-17.6|-27.4|<0.0001
91502087|NCT02584504|182875047|SUPERIORITY||LS Mean Difference|-41.4|||<|0.0001|TWO_SIDED|97.5|-46.4|-36.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-36.5|-46.4|<0.0001
91502088|NCT02584504|182875048|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|13.9|268.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||268.9|13.9|<0.0001
91502089|NCT02584504|182875048|SUPERIORITY||Odds Ratio (OR)|281.4|||<|0.0001|TWO_SIDED|97.5|33.3|2382.2||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||2382.2|33.3|<0.0001
91502090|NCT02584504|182875049|SUPERIORITY||Odds Ratio (OR)|102.8|||<|0.0001|TWO_SIDED|97.5|19.0|556.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||556.8|19.0|<0.0001
91746185|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.69|0.82|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - South Korea||0.82|0.69|
91746186|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.78|0.94|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Norway||0.94|0.78|
91746187|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.66|0.89|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Spain||0.89|0.66|
91746188|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.81|0.93|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Sweden||0.93|0.81|
91746189|NCT03817463|183385590|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.74|0.86|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Taiwan||0.86|0.74|
91502091|NCT02584504|182875049|SUPERIORITY||Odds Ratio (OR)|500.8|||<|0.0001|TWO_SIDED|97.5|47.9|5230.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||5230.9|47.9|<0.0001
91502092|NCT02584504|182875050|SUPERIORITY||Adjusted Mean Difference|-32.9|||<|0.0001|TWO_SIDED|97.5|-43.4|-22.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-22.5|-43.4|<0.0001
91502093|NCT02584504|182875050|SUPERIORITY||Adjusted Mean Difference|-50.9|||<|0.0001|TWO_SIDED|97.5|-61.5|-40.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-40.3|-61.5|<0.0001
91746190|NCT03817463|183385590|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.64|0.71|||||Poisson regression model was used.|All-cause hospital admissions||0.71|0.64|
91746191|NCT03817463|183385590|OTHER||Rate Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76|||||Poisson regression model was used.|For all-cause hospital admissions - Japan||0.76|0.63|
91746192|NCT03817463|183385590|OTHER||Rate Ratio|0.7|||||TWO_SIDED|95.0|0.66|0.75|||||Poisson regression model was used.|All-cause hospital admissions - South Korea||0.75|0.66|
91746193|NCT03817463|183385590|OTHER||Rate Ratio|0.81|||||TWO_SIDED|95.0|0.77|0.85|||||Poisson regression model was used.|All-cause hospital admissions - Norway||0.85|0.77|
91746194|NCT03817463|183385590|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||Poisson regression model was used.|All-cause hospital admissions - Spain||0.77|0.60|
91502094|NCT02584504|182875051|SUPERIORITY||LS Mean Difference|5.7||||0.0241|TWO_SIDED|97.5|0.0|11.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||11.3|0.0|0.0241
91502095|NCT02584504|182875051|SUPERIORITY||LS Mean Difference|7.8||||0.0022|TWO_SIDED|97.5|2.1|13.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||13.5|2.1|0.0022
91502096|NCT02584504|182875052|SUPERIORITY||Adjusted Mean Difference|5.9||||0.2645|TWO_SIDED|97.5|-5.9|17.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||17.7|-5.9|0.2645
91502097|NCT02584504|182875052|SUPERIORITY||Adjusted Mean Difference|-11.6||||0.0299|TWO_SIDED|97.5|-23.5|0.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.4|-23.5|0.0299
91502098|NCT02432846|182875055|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.978||||0.964|TWO_SIDED|95.0|0.371|2.579|||Log Rank|||||2.579|0.371|0.964
91502099|NCT02432846|182875055|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.619||||0.163|TWO_SIDED|95.0|0.314|1.222|||Log Rank|||||1.222|0.314|0.163
91502100|NCT02432846|182875055|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.732||||0.25|TWO_SIDED|95.0|0.421|1.27|||Log Rank|||||1.270|0.421|0.250
91531609|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-15.0|<0.001
91531610|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.8||0.001|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.001
91746195|NCT03817463|183385590|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.8|0.89|||||Poisson regression model was used.|All-cause hospital admissions - Sweden||0.89|0.80|
91746196|NCT03817463|183385590|OTHER||Rate Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.87||||||All-cause hospital admissions - Taiwan||0.87|0.72|
91502101|NCT02432846|182875056|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.756||||0.596|TWO_SIDED|95.0|0.268|2.134|||Log Rank|||||2.134|0.268|0.596
91502102|NCT02432846|182875056|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.661||||0.285|TWO_SIDED|95.0|0.308|1.418|||Log Rank|||||1.418|0.308|0.285
91502103|NCT02432846|182875056|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.699||||0.24|TWO_SIDED|95.0|0.378|1.29|||Log Rank|||||1.290|0.378|0.240
91502104|NCT02432846|182875057|OTHER|Exploratory superiority (non-powered)|||||=|0.812|||||||Log Rank|||||||= 0.812
91502105|NCT02432846|182875058|OTHER|Exploratory superiority (non-powered)|||||=|0.861|||||||Log Rank|||||||= 0.861
91502106|NCT03992781|182875089|SUPERIORITY||Relative change|-53.1|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502107|NCT03992781|182875090|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502108|NCT03992781|182875091|SUPERIORITY||Relative change|-33.2|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502109|NCT03992781|182875091|SUPERIORITY||Relative change|-47.1|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91746197|NCT03817463|183385590|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.77|0.79|||||Poisson regression model was used.|Outpatient healthcare visits - Finland||0.79|0.77|
91746198|NCT03817463|183385590|OTHER||Rate Ratio|0.95|||||TWO_SIDED|95.0|0.94|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - Japan||0.97|0.94|
91746199|NCT03817463|183385590|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.96|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - South Korea||0.97|0.96|
91746200|NCT03817463|183385590|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.97||||||Outpatient healthcare visits - Norway||0.97|0.94|
91502110|NCT03992781|182875092|SUPERIORITY||Relative change|-27.6|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502111|NCT03992781|182875092|SUPERIORITY||Relative change|-34.5|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502112|NCT03992781|182875093|SUPERIORITY||Relative change|-43.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502113|NCT03992781|182875093|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
91502114|NCT01996826|182875101|OTHER|Based on prior studies endothelial rejection episodes tend to occur in the range of about 60% of transplants. We used rates ranging from 50 to 70 % to compute the sample size. We specified the probability of a type 1 error equal to 0.05, study power equal to 80%, a follow-up period of 12 months, and 4% loss to follow-up. Calculations resulted in sample size estimates of between 65 and 124 participants.|Hazard Ratio (HR)|0.35||||0.1|TWO_SIDED|95.0|0.12|1.14|||Log Rank|||Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.||1.14|0.12|0.10
91502115|NCT01996826|182875102|OTHER|The count of ocular adverse events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.|Risk Ratio (RR)|0.92||||0.36|TWO_SIDED|95.0|0.78|1.06|||Fisher Exact|||The incidence of Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.06|0.78|0.36
91502116|NCT01996826|182875102|OTHER|Mild ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.63|1.4|||Fisher Exact|||The number of mild severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.4|0.63|0.82
91502117|NCT01996826|182875102|OTHER|Moderate severity ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95|||>|0.99|TWO_SIDED|95.0|0.41|2.2|||Fisher Exact|||The number of moderate severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||2.2|0.41|>0.99
91502118|NCT01996826|182875102|OTHER|Severe ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.63||||0.51|TWO_SIDED|95.0|0.2|1.9|||Fisher Exact|||Severe ocular adverse events for subjects in intervention group and control group were counted and compared.||1.9|0.20|0.51
91502119|NCT01996826|182875103|OTHER|The incidence of Systematic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were calculated and compared.|Risk Ratio (RR)|0.92||||0.24|TWO_SIDED|95.0|0.79|1.02|||Fisher Exact|||||1.02|0.79|0.24
91531611|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
91746201|NCT03817463|183385590|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.85|0.91|||||Poisson regression model was used.|Outpatient healthcare visit - Spain||0.91|0.85|
91746202|NCT03817463|183385590|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.98|||||Poisson regression model was used.|Outpatient healthcare visits - Sweden||0.98|0.94|
91746203|NCT03817463|183385590|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.94|1.0|||||Poisson regression model was used.|Outpatient healthcare visits - Taiwan||1.00|0.94|
91746204|NCT03817463|183385591|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.89|0.94|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Japan||0.94|0.89|
91746205|NCT03817463|183385591|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.81|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - South Korea||0.93|0.81|
91746206|NCT03817463|183385591|OTHER||Rate Ratio|1.09|||||TWO_SIDED|95.0|1.08|1.11|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Taiwan||1.11|1.08|
91746207|NCT03817463|183385591|OTHER||Rate Ratio|1.11|||||TWO_SIDED|95.0|1.1|1.12|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Finland||1.12|1.10|
91746208|NCT03817463|183385591|OTHER||Rate Ratio|0.82|||||TWO_SIDED|95.0|0.81|0.83|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Japan||0.83|0.81|
91746209|NCT03817463|183385591|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.99|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - South Korea||1.00|0.99|
91746210|NCT03817463|183385591|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|1.11|1.14|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Norway||1.14|1.11|
91746211|NCT03817463|183385591|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.25|1.27|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Sweden||1.27|1.25|
91746212|NCT03817463|183385591|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Taiwan||1.02|0.98|
91746213|NCT03817463|183385591|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|1.01|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Finland||1.02|1.01|
91746214|NCT03817463|183385591|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.82|0.84|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Japan||0.84|0.82|
91746215|NCT03817463|183385591|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - South Korea||1.01|0.99|
91746216|NCT03817463|183385591|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.92|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Norway||0.93|0.92|
91746217|NCT03817463|183385591|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.84|0.87|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Spain||0.87|0.84|
91746218|NCT03817463|183385591|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Sweden||1.00|1.00|
91502120|NCT01996826|182875103|OTHER|Mild severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.62||||0.4|TWO_SIDED|95.0|0.68|3.9|||Fisher Exact|||The number of mild systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||3.9|0.68|0.40
91502121|NCT01996826|182875103|OTHER|Moderate severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.95|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of moderate severity systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
91746219|NCT03817463|183385592|OTHER||Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.94|||||Poisson regression model was used.|Total cost - Finland||0.94|0.83|
91746220|NCT03817463|183385592|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||Poisson regression model was used.|Total costs - Norway||1.12|0.86|
91746221|NCT03817463|183385592|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.92|1.05|||||Poisson regression model was used.|Total costs - Sweden||1.05|0.92|
91746222|NCT03817463|183385593|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.8|0.88|||||Poisson regression model was used.|||0.88|0.80|
91746223|NCT03817463|183385594|OTHER||Rate Ratio|0.76|||||TWO_SIDED|95.0|0.34|1.68|||||Poisson regression model was used.|Total costs - South Korea||1.68|0.34|
91746224|NCT03817463|183385595|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.92|1.03|||||Poisson regression model was used.|Total costs - Taiwan||1.03|0.92|
91746225|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.4261|||||||t-test, 1 sided|||||||0.4261
91746226|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.4219|||||||t-test, 1 sided|||||||0.4219
91746227|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.1826|||||||t-test, 1 sided|||||||0.1826
91746228|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0090
91746229|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.3421|||||||t-test, 1 sided|||||||0.3421
91746230|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0100
91746231|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.2103|||||||t-test, 1 sided|||||||0.2103
91746232|NCT01018134|183385654|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 1 sided|||||||0.1200
91746233|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.2631|||||||t-test, 1 sided|||||||0.2631
91746234|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.2968|||||||t-test, 1 sided|||||||0.2968
91746235|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.0186||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0186
91746236|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.0361||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0361
91746237|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.007||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0070
91746238|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.1583|||||||t-test, 1 sided|||||||0.1583
91746239|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.2078|||||||t-test, 1 sided|||||||0.2078
91746240|NCT01018134|183385655|SUPERIORITY_OR_OTHER|||||||0.2878|||||||t-test, 1 sided|||||||0.2878
91746241|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.2713|||||||Wilcoxon (Mann-Whitney)|||||||0.2713
91746242|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.2689|||||||Wilcoxon (Mann-Whitney)|||||||0.2689
91746243|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.0419|||||||Wilcoxon (Mann-Whitney)|||||||0.0419
91746244|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.0309|||||||Wilcoxon (Mann-Whitney)|||||||0.0309
91746245|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.1126|||||||Wilcoxon (Mann-Whitney)|||||||0.1126
91746246|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Wilcoxon (Mann-Whitney)|||||||0.0033
91746247|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.4967|||||||Wilcoxon (Mann-Whitney)|||||||0.4967
91746248|NCT01018134|183385656|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Wilcoxon (Mann-Whitney)|||||||0.0749
91746249|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.2442|||||||Wilcoxon (Mann-Whitney)|||||||0.2442
91746250|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Wilcoxon (Mann-Whitney)|||||||0.2664
91746251|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.1328|||||||Wilcoxon (Mann-Whitney)|||||||0.1328
91746252|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||||||0.0528
91746253|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||||||0.0297
91746254|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Wilcoxon (Mann-Whitney)|||||||0.0093
91746255|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.2230
91746256|NCT01018134|183385657|SUPERIORITY_OR_OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
91746257|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.2397|||||||Wilcoxon (Mann-Whitney)|||||||0.2397
91746258|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Wilcoxon (Mann-Whitney)|||||||0.3794
91746259|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.0383|||||||Wilcoxon (Mann-Whitney)|||||||0.0383
91746260|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.0154|||||||Wilcoxon (Mann-Whitney)|||||||0.0154
91502122|NCT01996826|182875103|OTHER|Severe systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.9|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of severe systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
91746261|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.1892|||||||Wilcoxon (Mann-Whitney)|||||||0.1892
91746262|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
91746263|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.0363|||||||Wilcoxon (Mann-Whitney)|||||||0.0363
91746264|NCT01018134|183385658|SUPERIORITY_OR_OTHER|||||||0.2162|||||||Wilcoxon (Mann-Whitney)|||||||0.2162
91746265|NCT01751906|183385660|SUPERIORITY|||||||0.9256|||||||Chi-squared|||||||0.9256
91746266|NCT01751906|183385661|SUPERIORITY|||||||0.504|||||||Fisher Exact|||||||0.5040
91746267|NCT01751906|183385662|SUPERIORITY|||||||0.2126|||||||Fisher Exact|||||||0.2126
91746268|NCT01751906|183385689|SUPERIORITY|||||||0.0665|||||||Chi-squared|||||||0.0665
91746269|NCT01981863|183385713|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
91746270|NCT02383420|183385727|SUPERIORITY_OR_OTHER|||||||0.415|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.415
91746271|NCT02383420|183385728|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.0000
91746272|NCT00420004|183385729|SUPERIORITY_OR_OTHER|||||||0.494|||||||Mixed Models Analysis|||||||0.494
91746273|NCT03002818|183385749|SUPERIORITY||mean change|-108266.0||||0.091|TWO_SIDED|95.0|-235037.0|18504.0|||one-sample t-test|||sdITT (n=26): Change at Day 168 minus Baseline||18504|-235037|0.091
91746274|NCT03002818|183385749|SUPERIORITY||mean change|-98373.0||||0.152|TWO_SIDED|95.0|-235667.0|38921.0|||one-sample t-test|||mITT (n=24): Change at Day 168 minus Baseline||38921|-235667|0.152
91746275|NCT03002818|183385749|SUPERIORITY|||||||0.091|||||||paired t-test|||sdITT (n=26): Baseline vs. Day 168||||0.091
91746276|NCT03002818|183385749|SUPERIORITY|||||||0.152|||||||paired t-test|||mITT (n=24): Baseline vs. Day 168||||0.152
91746277|NCT03002818|183385750|SUPERIORITY|||||||0.461|||||||paired t-test|||sdITT (n=34): Baseline vs. Day 28||||0.461
91746278|NCT03002818|183385750|SUPERIORITY|||||||0.63|||||||paired t-test|||mITT (n=24): Baseline vs. Day 28||||0.630
91746279|NCT03002818|183385750|SUPERIORITY|||||||0.855|||||||paired t-test|||sdITT (n=32): Baseline vs. Day 84||||0.855
91746280|NCT03002818|183385750|SUPERIORITY|||||||0.75|||||||paired t-test|||mITT (n=24): Baseline vs. Day 84||||0.750
91746281|NCT03002818|183385751|SUPERIORITY||mean change|2.6|||||TWO_SIDED|95.0|2.063|3.137||||||sdITT: mean change Baseline minus Day 168||3.137|2.063|
91746282|NCT03002818|183385751|SUPERIORITY||mean change|2.82|||||TWO_SIDED|95.0|2.212|3.428||||||mITT: mean change Baseline minus Day 168||3.428|2.212|
91746283|NCT03002818|183385751|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||<0.001
91746284|NCT03002818|183385751|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||<0.001
91746285|NCT03002818|183385751|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||<0.001
91746286|NCT03002818|183385751|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||<0.001
91746287|NCT03002818|183385751|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||<0.001
91746288|NCT03002818|183385751|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=23): Baseline vs. Day 84||||<0.001
91746289|NCT03002818|183385752|SUPERIORITY||mean change|0.61|||||TWO_SIDED|95.0|-0.651|1.871||||||sdITT: mean change Baseline minus Day 168||1.871|-0.651|
91746290|NCT03002818|183385752|SUPERIORITY||mean change|0.74|||||TWO_SIDED|95.0|-0.608|2.088||||||mITT: mean change Baseline minus Day 168||2.088|-0.608|
91746291|NCT03002818|183385752|SUPERIORITY|||||||0.381|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||0.381
91746292|NCT03002818|183385752|SUPERIORITY|||||||0.304|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||0.304
91746293|NCT03002818|183385752|SUPERIORITY|||||||0.014|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||0.014
91746294|NCT03002818|183385752|SUPERIORITY|||||||0.278|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||0.278
91746295|NCT03002818|183385752|SUPERIORITY|||||||0.881|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||0.881
91746296|NCT03002818|183385752|SUPERIORITY|||||||0.775|||||||Paired Wilcoxon Test|||sdITT (n=23): Baseline vs. Day 84||||0.775
91746297|NCT01942668|183385765|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
91746298|NCT01942668|183385765|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
91746299|NCT01942668|183385765|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||1.59|-11.21|0.141
91513606|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.91|||<|0.001|TWO_SIDED|95.0|0.84|1.0|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.00|0.84|< 0.001
91502123|NCT00518323|182875113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|3.17||0.508||95.0|-8.36|4.16||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||4.16|-8.36|0.508
91502124|NCT00518323|182875113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|3.27||0.006||95.0|-16.58|-3.67||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-3.67|-16.58|0.006
91502125|NCT00518323|182875113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|3.29||0.086||95.0|-13.07|-0.09||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-0.09|-13.07|0.086
91502126|NCT00518323|182875114|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.968
91502127|NCT00518323|182875114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
91502128|NCT00518323|182875114|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.021
91746300|NCT01942668|183385765|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
91746301|NCT01942668|183385766|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
91746302|NCT01942668|183385766|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
91746303|NCT01942668|183385766|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
91746304|NCT01942668|183385766|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
91746305|NCT01942668|183385767|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
91502129|NCT00518323|182875115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0|-4.54|3.73||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.73|-4.54|0.846
91502130|NCT00518323|182875115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.17|<|0.001||95.0|4.28|12.82||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||12.82|4.28|<0.001
91746306|NCT01942668|183385767|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
91502131|NCT00518323|182875115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|2.18||0.067||95.0|-0.28|8.33||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||8.33|-0.28|0.067
91502132|NCT00518323|182875116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|4.27||0.058||95.0|-0.29|16.56||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||16.56|-0.29|0.058
91502133|NCT00518323|182875116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.8|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|8.08|25.43||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||25.43|8.08|<0.001
91502134|NCT00518323|182875116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|4.43||0.003||95.0|4.76|22.23||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||22.23|4.76|0.003
91531612|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
91746307|NCT01942668|183385767|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.07|-0.17|0.401
91746308|NCT01942668|183385767|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.02|-0.21|0.100
91746309|NCT01942668|183385768|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
91531613|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.0||0.009|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.009
91746310|NCT01942668|183385768|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
91746311|NCT01942668|183385768|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
91502135|NCT00518323|182875117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|4.15||0.237||95.0|-13.11|3.26||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.26|-13.11|0.237
91502136|NCT00518323|182875117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|4.28||0.119||95.0|-15.15|1.74||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||1.74|-15.15|0.119
91746312|NCT01942668|183385768|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.03|-0.36|0.096
91502137|NCT00518323|182875117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.34||0.574||95.0|-11.0|6.11||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||6.11|-11.00|0.574
91502138|NCT03164928|182875118|SUPERIORITY||Least Squares Mean Difference|0.11||||0.68|TWO_SIDED|95.0|-0.45|0.673|||ANCOVA|||||0.673|-0.450|0.68
91502139|NCT03164928|182875119|SUPERIORITY||Least Squares Mean Difference|0.17||||0.34|TWO_SIDED|95.0|-0.194|0.542|||Repeated Measures Model|||Month 6||0.542|-0.194|0.34
91502140|NCT03164928|182875119|SUPERIORITY||Least Squares Mean Difference|0.03||||0.93|TWO_SIDED|95.0|-0.609|0.661|||Repeated Measures Model|||Month 18||0.661|-0.609|0.93
91502141|NCT03164928|182875119|SUPERIORITY||Least Squares Mean Difference|0.11||||0.74|TWO_SIDED|95.0|-0.572|0.795|||Repeated Measures Model|||Month 24||0.795|-0.572|0.74
91502142|NCT03164928|182875119|SUPERIORITY||Least Squares Means Difference|-0.8||||0.12|TWO_SIDED|95.0|-1.848|0.239|||Repeated Measures Model|||Month 36||0.239|-1.848|0.12
91502143|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|-0.41||||0.19|TWO_SIDED|95.0|-1.05|0.223|||Repeated Measures Model|||Month 6 (Total Hip)||0.223|-1.050|0.19
91502144|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.83|TWO_SIDED|95.0|-0.631|0.515|||Repeated Measures Model|||Month 12 (Total Hip)||0.515|-0.631|0.83
91502145|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|-0.27||||0.51|TWO_SIDED|95.0|-1.108|0.565|||Repeated Measures Model|||Month 18 (Total Hip)||0.565|-1.108|0.51
91502146|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.69|TWO_SIDED|95.0|-1.098|0.746|||Repeated Measures Model|||Month 24 (Total Hip)||0.746|-1.098|0.69
91502147|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|-0.09||||0.89|TWO_SIDED|95.0|-1.465|1.286|||Repeated Measures Model|||Month 36 (Total Hip)||1.286|-1.465|0.89
91531614|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.0||0.003|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.003
91502148|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.64|TWO_SIDED|95.0|-0.969|0.614|||Repeated Measures Model|||Month 6 (Femoral Neck)||0.614|-0.969|0.64
91502149|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|0.1||||0.83|TWO_SIDED|95.0|-0.808|1.0|||Repeated Measures Model|||Month 12 (Femoral Neck)||1.000|-0.808|0.83
91502150|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|0.37||||0.48|TWO_SIDED|95.0|-0.697|1.442|||Repeated Measures Model|||Month 18 (Femoral Neck)||1.442|-0.697|0.48
91502151|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|0.11||||0.86|TWO_SIDED|95.0|-1.222|1.443|||Repeated Measures Model|||Month 24 (Femoral Neck)||1.443|-1.222|0.86
91502152|NCT03164928|182875120|SUPERIORITY||Least Squares Mean Difference|0.38||||0.66|TWO_SIDED|95.0|-1.378|2.13|||Repeated Measures Model|||Month 36 (Femoral Neck)||2.130|-1.378|0.66
91502153|NCT01514760|182875147|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.||||0.03
91502154|NCT03329690|182875159|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH test with region as a stratification factor||||||<0.0001
91502155|NCT01519414|182875213|OTHER|||||||0.02|||||||Log Rank|||||||0.02
91502156|NCT00531817|182875248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.85|||<|0.0001|TWO_SIDED|95.0|12.29|25.42||The p-value was not adjusted. The primary objective was a single comparison with an a priori threshold of 0.05 for statistical significance.|Fisher Exact|||Power calculation: Assuming placebo+DMARDs response rate of 15% and tocilizumab 8 mg/kg+DMARDs response rate of 28% based on previous trials, a sample size of 570 patients (2:1 ratio, tocilizumab+DMARDs n=380 and placebo+DMARDs n=190) will provide \> 90% power to detect a difference between 2 treatment arms with 5% Type I error with a 2-sided Fisher's exact test. Null Hypothesis: The percentage of patients responding in each treatment group (tocilizumab+DMARDs vs placebo+ DMARDs) is the same.||25.42|12.29|<0.0001
91502157|NCT03204305|182875268|SUPERIORITY||t-test|-2.51||||0.02|TWO_SIDED|||||p \< 0.05 for all analyses. Bonferroni corrections were made to reduce family-wise error rate.|t-test, 2 sided|Composite VT was compared using independent t-tests.||VT in the 8 volumes of interest were analyzed using linear regression model group coded encoded as a dummy variable \[1=females cannabis users; 2= female healthy controls\], age as a covariate, and VT for VOIs (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as dependent variables, followed by post hoc Tukey's HSD between between groups.||||0.02
91502158|NCT03204305|182875268|SUPERIORITY||t-test|-2.36||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91502159|NCT03204305|182875268|SUPERIORITY||t-test|-2.35||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91502160|NCT03204305|182875268|SUPERIORITY||t-test|-2.23||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
91502161|NCT03204305|182875269|SUPERIORITY||t test|-2.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91502162|NCT03388294|182875294|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|7.32||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
91502163|NCT03388294|182875295|OTHER||Mean Difference (Net)|12.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The focus for this analysis is change over time||||<0.001
91502164|NCT03388294|182875296|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||0.87
91502165|NCT03388294|182875297|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.61||||0.006|TWO_SIDED||||||Mixed Models Analysis|||||||0.006
91502166|NCT03388294|182875298|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
91502167|NCT03388294|182875299|OTHER|The focus for this analysis is change over time||||||0.849|||||||Mixed Models Analysis|||||||0.849
91502168|NCT03388294|182875300|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.2||||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
91502169|NCT03388294|182875301|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91502170|NCT03388294|182875305|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|-2.9||||0.036|TWO_SIDED||||||Mixed Models Analysis|||||||0.036
91502171|NCT03388294|182875306|OTHER|The focus for this analysis is change over time||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
91502172|NCT03388294|182875307|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.36||||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
91502173|NCT03388294|182875308|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|3.14||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
91531615|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
91746313|NCT01942668|183385769|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
91746314|NCT01942668|183385769|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
91502174|NCT03388294|182875309|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.881|TWO_SIDED||||||Mixed Models Analysis|||||||0.881
91502175|NCT03388294|182875310|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
91502176|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066||||0.036|TWO_SIDED|95.0|0.004|0.127|||Mixed Models Analysis|||||0.127|0.004|0.036
91502177|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.331|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.090|-0.030|0.331
91502178|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||Mixed Models Analysis|||||0.095|-0.027|0.272
91746315|NCT01942668|183385769|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
91746316|NCT01942668|183385769|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
91746317|NCT01942668|183385769|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
91746318|NCT01942668|183385770|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
91502179|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.005|TWO_SIDED|95.0|0.026|0.149|||Mixed Models Analysis|||||0.149|0.026|0.005
91746319|NCT01942668|183385770|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
91746320|NCT01942668|183385770|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
91746321|NCT01942668|183385770|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
91746322|NCT01942668|183385770|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
91746323|NCT01942668|183385771|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.51||0.588|TWO_SIDED|95.0|-3.57|6.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.30|-3.57|0.588
91746324|NCT01942668|183385771|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|2.47||0.601|TWO_SIDED|95.0|-3.56|6.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.15|-3.56|0.601
91746325|NCT01942668|183385771|SUPERIORITY||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|2.49||0.202|TWO_SIDED|95.0|-1.71|8.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.06|-1.71|0.202
91746326|NCT01942668|183385771|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.46||0.431|TWO_SIDED|95.0|-6.76|2.89||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.89|-6.76|0.431
91746327|NCT01942668|183385772|SUPERIORITY||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|3.05||0.154|TWO_SIDED|95.0|-10.34|1.64||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.64|-10.34|0.154
91502180|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.722|TWO_SIDED|95.0|-0.05|0.073|||Mixed Models Analysis|||||0.073|-0.050|0.722
91502181|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.076|TWO_SIDED|95.0|-0.006|0.119|||Mixed Models Analysis|||||0.119|-0.006|0.076
91502182|NCT01641692|182875353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051||||0.101|TWO_SIDED|95.0|-0.01|0.113|||Mixed Models Analysis|||||0.113|-0.010|0.101
91502183|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.840
91502184|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.553|TWO_SIDED|95.0|-2.4|1.3|||Mixed Models Analysis|||||1.3|-2.4|0.553
91746328|NCT01942668|183385772|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|3.0||0.956|TWO_SIDED|95.0|-6.06|5.73||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||5.73|-6.06|0.956
91746329|NCT01942668|183385772|SUPERIORITY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|3.01||0.24|TWO_SIDED|95.0|-2.37|9.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||9.46|-2.37|0.240
91746330|NCT01942668|183385772|SUPERIORITY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|2.98||0.353|TWO_SIDED|95.0|-8.62|3.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.08|-8.62|0.353
91746331|NCT01942668|183385773|SUPERIORITY||Mean Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.16||0.007|TWO_SIDED|95.0|-14.75|-2.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.36|-14.75|0.007
91746332|NCT01942668|183385773|SUPERIORITY||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|3.11||0.227|TWO_SIDED|95.0|-9.86|2.35||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.35|-9.86|0.227
91746333|NCT01942668|183385773|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.12||0.597|TWO_SIDED|95.0|-7.77|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||4.47|-7.77|0.597
91746334|NCT01942668|183385773|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|3.08||0.019|TWO_SIDED|95.0|-13.28|-1.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.19|-13.28|0.019
91746335|NCT01942668|183385774|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
91746336|NCT01942668|183385774|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
91746337|NCT01942668|183385774|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.59|-11.21|0.141
91746338|NCT01942668|183385774|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
91746339|NCT01942668|183385775|SUPERIORITY||Mean Difference (Final Values)|-15.59|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-22.16|-9.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.02|-22.16|<0.001
91746340|NCT01942668|183385775|SUPERIORITY||Mean Difference (Final Values)|-9.88|STANDARD_ERROR_OF_MEAN|3.29||0.003|TWO_SIDED|95.0|-16.34|-3.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.41|-16.34|0.003
91746341|NCT01942668|183385775|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.31||0.075|TWO_SIDED|95.0|-12.4|0.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.59|-12.40|0.075
91746342|NCT01942668|183385775|SUPERIORITY||Mean Difference (Final Values)|-12.05|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-18.47|-5.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.64|-18.47|<0.001
91502185|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.121|TWO_SIDED|95.0|-0.4|3.3|||Mixed Models Analysis|||||3.3|-0.4|0.121
91502186|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.814|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.814
91746343|NCT01942668|183385776|SUPERIORITY||Mean Difference (Final Values)|-17.87|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.57|-11.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.05|-24.57|<0.001
91746344|NCT01942668|183385776|SUPERIORITY||Mean Difference (Final Values)|-11.35|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-18.0|-4.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.70|-18.00|<0.001
91746345|NCT01942668|183385776|SUPERIORITY||Mean Difference (Final Values)|-7.82|STANDARD_ERROR_OF_MEAN|3.4||0.022|TWO_SIDED|95.0|-14.5|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.14|-14.50|0.022
91746346|NCT01942668|183385776|SUPERIORITY||Mean Difference (Final Values)|-12.51|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.11|-5.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.91|-19.11|<0.001
91746347|NCT01942668|183385777|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-24.45|-11.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.06|-24.45|<0.001
91502187|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.683|TWO_SIDED|95.0|-1.5|2.3|||Mixed Models Analysis|||||2.3|-1.5|0.683
91746348|NCT01942668|183385777|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.88|-6.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.70|-19.88|<0.001
91746349|NCT01942668|183385777|SUPERIORITY||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|3.37||0.003|TWO_SIDED|95.0|-16.83|-3.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.60|-16.83|0.003
91746350|NCT01942668|183385777|SUPERIORITY||Mean Difference (Final Values)|-13.61|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-20.15|-7.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.07|-20.15|<0.001
91746351|NCT01942668|183385778|SUPERIORITY||Mean Difference (Final Values)|-16.63|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.35|-9.91||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.91|-23.35|<0.001
91746352|NCT01942668|183385778|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.58|-6.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.36|-19.58|<0.001
91746353|NCT01942668|183385778|SUPERIORITY||Mean Difference (Final Values)|-9.63|STANDARD_ERROR_OF_MEAN|3.38||0.005|TWO_SIDED|95.0|-16.27|-2.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.99|-16.27|0.005
91746354|NCT01942668|183385778|SUPERIORITY||Mean Difference (Final Values)|-11.97|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-18.53|-5.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.41|-18.53|<0.001
91746355|NCT01942668|183385779|SUPERIORITY||Mean Difference (Final Values)|-17.12|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.79|-10.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.44|-23.79|<0.001
91746356|NCT01942668|183385779|SUPERIORITY||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-22.15|-9.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.01|-22.15|<0.001
91746357|NCT01942668|183385779|SUPERIORITY||Mean Difference (Final Values)|-11.05|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.65|-4.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.44|-17.65|0.001
91746358|NCT01942668|183385779|SUPERIORITY||Mean Difference (Final Values)|-13.02|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-19.54|-6.5||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.50|-19.54|<0.001
91746359|NCT01942668|183385780|SUPERIORITY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-23.58|-10.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.03|-23.58|<0.001
91746360|NCT01942668|183385780|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-22.32|-8.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.99|-22.32|<0.001
91746361|NCT01942668|183385780|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|3.41||0.001|TWO_SIDED|95.0|-17.9|-4.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.49|-17.90|0.001
91746362|NCT01942668|183385780|SUPERIORITY||Mean Difference (Final Values)|-12.16|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-18.78|-5.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.55|-18.78|<0.001
91746363|NCT01942668|183385781|SUPERIORITY||Mean Difference (Final Values)|-18.11|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-24.92|-11.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.29|-24.92|<0.001
91502188|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.456|TWO_SIDED|95.0|-1.2|2.7|||Mixed Models Analysis|||||2.7|-1.2|0.456
91502189|NCT01641692|182875356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.399|TWO_SIDED|95.0|-2.7|1.1|||Mixed Models Analysis|||||1.1|-2.7|0.399
91502190|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.03|TWO_SIDED|95.0|0.2|3.2|||Mixed Models Analysis|||||3.2|0.2|0.030
91502191|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.077|TWO_SIDED|95.0|-0.1|2.8|||Mixed Models Analysis|||||2.8|-0.1|0.077
91502192|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.01|TWO_SIDED|95.0|0.5|3.5|||Mixed Models Analysis|||||3.5|0.5|0.010
91502193|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.002|TWO_SIDED|95.0|0.9|3.9|||Mixed Models Analysis|||||3.9|0.9|0.002
91502194|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.005|TWO_SIDED|95.0|0.7|3.7|||Mixed Models Analysis|||||3.7|0.7|0.005
91502195|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.2|4.3|||Mixed Models Analysis|||||4.3|1.2|<0.001
91746364|NCT01942668|183385781|SUPERIORITY||Mean Difference (Final Values)|-16.45|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.17|-9.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.74|-23.17|<0.001
91746365|NCT01942668|183385781|SUPERIORITY||Mean Difference (Final Values)|-12.41|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-19.15|-5.66||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.66|-19.15|<0.001
91746366|NCT01942668|183385781|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-20.26|-6.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.93|-20.26|<0.001
91746367|NCT01942668|183385782|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
91746368|NCT01942668|183385782|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
91746369|NCT01942668|183385782|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
91746370|NCT01942668|183385782|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
91746371|NCT01942668|183385783|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.034||0.801|TWO_SIDED|95.0|-0.06|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.06|0.801
91746372|NCT01942668|183385783|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.991|TWO_SIDED|95.0|-0.07|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.07|0.991
91746373|NCT01942668|183385783|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.642|TWO_SIDED|95.0|-0.05|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.05|0.642
91502196|NCT01641692|182875357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.054|TWO_SIDED|95.0|0.0|3.0|||Mixed Models Analysis|||||3.0|0.0|0.054
91502197|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.4|2.0|||Mixed Models Analysis|||||2.0|-1.4|0.752
91502198|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.072|TWO_SIDED|95.0|-0.1|3.2|||Mixed Models Analysis|||||3.2|-0.1|0.072
91502199|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.503|TWO_SIDED|95.0|-1.1|2.2|||Mixed Models Analysis|||||2.2|-1.1|0.503
91746374|NCT01942668|183385783|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.928|TWO_SIDED|95.0|-0.07|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.07|0.928
91746375|NCT01942668|183385784|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.043||0.231|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.231
91746376|NCT01942668|183385784|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.042||0.173|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.173
91746377|NCT01942668|183385784|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.042||0.717|TWO_SIDED|95.0|-0.07|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.07|0.717
91746378|NCT01942668|183385784|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.849|TWO_SIDED|95.0|-0.09|0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.09|0.849
91746379|NCT01942668|183385785|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.039|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.039
91746380|NCT01942668|183385785|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.03|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.030
91746381|NCT01942668|183385785|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.052||0.946|TWO_SIDED|95.0|-0.1|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.10|0.946
91746382|NCT01942668|183385785|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.051||0.309|TWO_SIDED|95.0|-0.15|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.15|0.309
91746383|NCT01942668|183385786|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
91746384|NCT01942668|183385786|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
91746385|NCT01942668|183385786|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.17|0.401
91746386|NCT01942668|183385786|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.21|0.100
91746387|NCT01942668|183385787|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.071||0.001|TWO_SIDED|95.0|-0.37|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.37|0.001
91746388|NCT01942668|183385787|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.034|TWO_SIDED|95.0|-0.28|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.28|0.034
91746389|NCT01942668|183385787|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED|95.0|-0.16|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.16|0.790
91746390|NCT01942668|183385787|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.069||0.086|TWO_SIDED|95.0|-0.25|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.25|0.086
91746391|NCT01942668|183385788|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
91746392|NCT01942668|183385788|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.083||0.03|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.030
91502200|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.476|TWO_SIDED|95.0|-1.1|2.3|||Mixed Models Analysis|||||2.3|-1.1|0.476
91502201|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.084|TWO_SIDED|95.0|-0.2|3.2|||Mixed Models Analysis|||||3.2|-0.2|0.084
91746393|NCT01942668|183385788|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.083||0.247|TWO_SIDED|95.0|-0.26|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.26|0.247
91746394|NCT01942668|183385788|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.022|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.022
91746395|NCT01942668|183385789|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
91746396|NCT01942668|183385789|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.083||0.002|TWO_SIDED|95.0|-0.42|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.42|0.002
91746397|NCT01942668|183385789|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.084||0.031|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.031
91746398|NCT01942668|183385789|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.016|TWO_SIDED|95.0|-0.36|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.36|0.016
91746399|NCT01942668|183385790|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
91746400|NCT01942668|183385790|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.086||0.008|TWO_SIDED|95.0|-0.4|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.40|0.008
91746401|NCT01942668|183385790|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.087|TWO_SIDED|95.0|-0.32|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.32|0.087
91746402|NCT01942668|183385790|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.085||0.092|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.092
91746403|NCT01942668|183385791|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
91746404|NCT01942668|183385791|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.001|TWO_SIDED|95.0|-0.47|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.12|-0.47|0.001
91746405|NCT01942668|183385791|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.091||0.009|TWO_SIDED|95.0|-0.42|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.42|0.009
91746406|NCT01942668|183385791|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.007|TWO_SIDED|95.0|-0.42|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.42|0.007
91746407|NCT01942668|183385792|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
91746408|NCT01942668|183385792|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.094||0.003|TWO_SIDED|95.0|-0.46|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.46|0.003
91746409|NCT01942668|183385792|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.095||0.016|TWO_SIDED|95.0|-0.41|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.41|0.016
91746410|NCT01942668|183385792|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.31|TWO_SIDED|95.0|-0.28|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.28|0.310
91746411|NCT01942668|183385793|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
91746412|NCT01942668|183385793|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.56|-0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.19|-0.56|<0.001
91746413|NCT01942668|183385793|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.097||0.011|TWO_SIDED|95.0|-0.44|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.44|0.011
91746414|NCT01942668|183385793|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.076|TWO_SIDED|95.0|-0.36|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.36|0.076
91746415|NCT01942668|183385794|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
91746416|NCT01942668|183385794|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
91502202|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED|95.0|-1.8|1.7|||Mixed Models Analysis|||||1.7|-1.8|0.970
91502203|NCT01641692|182875358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.423|TWO_SIDED|95.0|-2.4|1.0|||Mixed Models Analysis|||||1.0|-2.4|0.423
91502204|NCT00657241|182875441|SUPERIORITY|All hemodynamic variables are continuous and all participants received both treatments, so paired-t analysis could be used. While paired t-tests do not necessarily require a power and sample size analysis, we estimated that 30 subjects were sufficient to detect an 8% difference in CTTI between comparators at p\<0.05 with a conservatively estimated power of 0.8.|||||<|0.05|||||||t-test, 2 sided|||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||<0.05
91502205|NCT00657241|182875443|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
91502206|NCT00657241|182875444|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|Paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
91746417|NCT01942668|183385794|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
91746418|NCT01942668|183385794|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.096
91746419|NCT01942668|183385795|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.88||0.865|TWO_SIDED|95.0|-5.16|6.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.14|-5.16|0.865
91746420|NCT01942668|183385795|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|2.83||0.847|TWO_SIDED|95.0|-5.01|6.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.10|-5.01|0.847
91531616|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.11|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.11
91746421|NCT01942668|183385795|SUPERIORITY||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.85||0.463|TWO_SIDED|95.0|-3.5|7.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||7.68|-3.50|0.463
91746422|NCT01942668|183385795|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|2.81||0.207|TWO_SIDED|95.0|-9.07|1.97||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.97|-9.07|0.207
91746423|NCT01942668|183385796|SUPERIORITY||Mean Difference (Final Values)|-5.07|STANDARD_ERROR_OF_MEAN|3.43||0.14|TWO_SIDED|95.0|-11.8|1.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.67|-11.80|0.140
91502207|NCT00657241|182875445|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
91746424|NCT01942668|183385796|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|3.38||0.982|TWO_SIDED|95.0|-6.7|6.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.55|-6.70|0.982
91746425|NCT01942668|183385796|SUPERIORITY||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|3.39||0.492|TWO_SIDED|95.0|-4.32|8.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.98|-4.32|0.492
91502208|NCT00657241|182875446|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
91502209|NCT02738151|182875453|NON_INFERIORITY|Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|Least Square (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.152|0.051||Threshold for significance at 0.025 level.|Mixed Models Analysis||Toujeo vs. Tresiba|A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.||0.051|-0.152|<.0001
91502210|NCT02738151|182875453|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052||0.3302|TWO_SIDED|95.0|-0.152|0.051|||Mixed Models Analysis|||Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was \<0 (zero).||0.051|-0.152|0.3302
91502211|NCT02921776|182875598|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
91502212|NCT02921776|182875599|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
91502213|NCT02921776|182875600|OTHER|||||||0.1|||||||Effect size|Effect size =-0.29||||||0.10
91502214|NCT02921776|182875600|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||.10
91502215|NCT02921776|182875601|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Benzodiazepine exposure||||0.02
91502216|NCT02921776|182875601|SUPERIORITY|||||||0.291|||||||Mixed Models Analysis|||Opioid Exposure||||0.291
91746426|NCT01942668|183385796|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|3.35||0.216|TWO_SIDED|95.0|-10.72|2.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.43|-10.72|0.216
91746427|NCT01942668|183385797|SUPERIORITY||Mean Difference (Final Values)|-10.38|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.26|-3.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.50|-17.26|0.003
91502217|NCT02921776|182875602|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
91746428|NCT01942668|183385797|SUPERIORITY||Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|3.45||0.277|TWO_SIDED|95.0|-10.53|3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.02|-10.53|0.277
91746429|NCT01942668|183385797|SUPERIORITY||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|3.46||0.394|TWO_SIDED|95.0|-9.75|3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.84|-9.75|0.394
91746430|NCT01942668|183385797|SUPERIORITY||Mean Difference (Final Values)|-7.86|STANDARD_ERROR_OF_MEAN|3.42||0.022|TWO_SIDED|95.0|-14.58|-1.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.15|-14.58|0.022
91502218|NCT02921776|182875603|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||||||0.32
91502219|NCT02921776|182875604|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.19|4.72|||Mixed Models Analysis|||||4.72|0.19|0.93
91502220|NCT02921776|182875605|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
91502221|NCT02921776|182875607|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
91502222|NCT02921776|182875608|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Baseline||||0.94
91502223|NCT02921776|182875608|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Patient Extubation or Discharge from ICU||||0.89
91502224|NCT02921776|182875608|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||1-Month||||0.38
91502225|NCT02921776|182875608|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||3-Month||||0.63
91502226|NCT02921776|182875608|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||.73
91502227|NCT02921776|182875609|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Baseline||||0.82
91502228|NCT02921776|182875609|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Patient extubation or discharge from ICU||||0.84
91502229|NCT02921776|182875609|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||1-month||||0.96
91502230|NCT02921776|182875609|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||3-Month||||0.17
91502231|NCT02921776|182875609|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||.39
91502232|NCT02921776|182875610|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||1-month||||0.26
91502233|NCT02921776|182875610|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||3-month||||0.25
91502234|NCT02921776|182875610|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||6-month||||0.79
91502235|NCT02921776|182875618|SUPERIORITY||Odds Ratio (OR)|0.23||||0.05|TWO_SIDED|95.0|0.05|1.01|||t-test, 2 sided|||||1.01|0.05|0.05
91502236|NCT02921776|182875618|SUPERIORITY||Odds Ratio (OR)|0.27||||0.1|TWO_SIDED|95.0|0.06|1.3|||Regression, Linear|||Adjusted for baseline communication difficulty||1.30|0.06|0.10
91502237|NCT05247229|182875619|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
91502238|NCT05247229|182875619|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
91502239|NCT05247229|182875620|SUPERIORITY||Slope|-0.42||||0.12|TWO_SIDED|95.0|-0.96|0.11|||Chi-squared|||Q6 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.11|-0.96|0.12
91502240|NCT05247229|182875620|SUPERIORITY||Slope|0.41||||0.21|TWO_SIDED|95.0|-0.23|1.05|||Chi-squared|||Q7 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.05|-0.23|0.21
91502241|NCT05247229|182875620|SUPERIORITY||Slope|0.07||||0.78|TWO_SIDED|95.0|-0.41|0.54|||Chi-squared|||Q15 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.54|-0.41|0.78
91502242|NCT05247229|182875621|SUPERIORITY||Slope|0.51||||0.01|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||Q1 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.86|0.16|0.01
91502243|NCT05247229|182875621|SUPERIORITY||Slope|0.09||||0.67|TWO_SIDED|95.0|-0.34|0.52|||Chi-squared|||Q2 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.34|0.67
91746431|NCT01942668|183385798|SUPERIORITY||Mean Difference (Final Values)|-15.32|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.75|-7.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.89|-22.75|<0.001
91502244|NCT05247229|182875621|SUPERIORITY||Slope|0.13||||0.35|TWO_SIDED|95.0|-0.15|0.41|||Chi-squared|||Q3 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.41|-0.15|0.35
91502245|NCT05247229|182875621|SUPERIORITY||Slope|0.09||||0.73|TWO_SIDED|95.0|-0.43|0.61|||Chi-squared|||Q4 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.61|-0.43|0.73
91746432|NCT01942668|183385798|SUPERIORITY||Mean Difference (Final Values)|-8.92|STANDARD_ERROR_OF_MEAN|3.73||0.017|TWO_SIDED|95.0|-16.24|-1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.60|-16.24|0.017
91746433|NCT01942668|183385798|SUPERIORITY||Mean Difference (Final Values)|-4.56|STANDARD_ERROR_OF_MEAN|3.74||0.223|TWO_SIDED|95.0|-11.9|2.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.78|-11.90|0.223
91746434|NCT01942668|183385798|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|3.69||0.002|TWO_SIDED|95.0|-18.57|-4.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.07|-18.57|0.002
91746435|NCT01942668|183385799|SUPERIORITY||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-24.65|-10.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.28|-24.65|<0.001
91746436|NCT01942668|183385799|SUPERIORITY||Mean Difference (Final Values)|-10.26|STANDARD_ERROR_OF_MEAN|3.6||0.005|TWO_SIDED|95.0|-17.33|-3.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.18|-17.33|0.005
91746437|NCT01942668|183385799|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.62||0.087|TWO_SIDED|95.0|-13.31|0.89||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.89|-13.31|0.087
91746438|NCT01942668|183385799|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-19.68|-5.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.65|-19.68|<0.001
91746439|NCT01942668|183385800|SUPERIORITY||Mean Difference (Final Values)|-20.32|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-27.77|-12.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.87|-27.77|<0.001
91502246|NCT05247229|182875621|SUPERIORITY||Slope|0.2||||0.23|TWO_SIDED|95.0|-0.13|0.52|||Chi-squared|||Q5 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.13|0.23
91502247|NCT05247229|182875621|SUPERIORITY||Slope|0.71||||0|TWO_SIDED|95.0|0.27|1.15|||Chi-squared|||Q9 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.15|0.27|0.00
91502248|NCT05247229|182875621|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
91502249|NCT05247229|182875621|SUPERIORITY||Slope|0.37||||0.1|TWO_SIDED|95.0|-0.07|0.82|||Chi-squared|||Q11 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.82|-0.07|0.10
91502250|NCT05247229|182875621|SUPERIORITY||Slope|0.3||||0.32|TWO_SIDED|95.0|-0.3|0.91|||Chi-squared|||Q12 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.91|-0.30|0.32
91502251|NCT05247229|182875621|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
91502252|NCT05247229|182875621|SUPERIORITY||Slope|0.35||||0.11|TWO_SIDED|95.0|-0.07|0.78|||Chi-squared|||Q14 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.78|-0.07|0.11
91746440|NCT01942668|183385800|SUPERIORITY||Mean Difference (Final Values)|-12.61|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-19.95|-5.28||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.28|-19.95|<0.001
91746441|NCT01942668|183385800|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|3.75||0.027|TWO_SIDED|95.0|-15.7|-0.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.96|-15.70|0.027
91746442|NCT01942668|183385800|SUPERIORITY||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-21.13|-6.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.58|-21.13|<0.001
91746443|NCT01942668|183385801|SUPERIORITY||Mean Difference (Final Values)|-21.45|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-28.87|-14.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.04|-28.87|<0.001
91746444|NCT01942668|183385801|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-23.39|-8.8||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.80|-23.39|<0.001
91746445|NCT01942668|183385801|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_ERROR_OF_MEAN|3.73||0.001|TWO_SIDED|95.0|-19.34|-4.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.68|-19.34|0.001
91746446|NCT01942668|183385801|SUPERIORITY||Mean Difference (Final Values)|-15.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-22.97|-8.49||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.49|-22.97|<0.001
91746447|NCT01942668|183385802|SUPERIORITY||Mean Difference (Final Values)|-20.52|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-28.06|-12.97||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.97|-28.06|<0.001
91746448|NCT01942668|183385802|SUPERIORITY||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.8|-7.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.95|-22.80|<0.001
91746449|NCT01942668|183385802|SUPERIORITY||Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|3.8||0.003|TWO_SIDED|95.0|-18.95|-4.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.03|-18.95|0.003
91746450|NCT01942668|183385802|SUPERIORITY||Mean Difference (Final Values)|-13.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-21.19|-6.46||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.46|-21.19|<0.001
91746451|NCT01942668|183385803|SUPERIORITY||Mean Difference (Final Values)|-20.34|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-27.93|-12.74||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.74|-27.93|<0.001
91746452|NCT01942668|183385803|SUPERIORITY||Mean Difference (Final Values)|-17.92|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-25.39|-10.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.45|-25.39|<0.001
91502253|NCT01921179|182875659|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score|||||<|0.01|||||||ANOVA|||||||<0.01
91502254|NCT01921179|182875660|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training||||||<0.001
91502255|NCT01921179|182875661|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||||>|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance||||||>0.05
91502256|NCT01921179|182875662|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|||||||<0.001
91502257|NCT01921179|182875663|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score|||||<|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score||||||<0.05
91502258|NCT01921179|182875664|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up|||||<|0.01|||||||ANOVA|||||||<0.01
91502259|NCT00858442|182875668|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks = 0.953, P\> 0.449 in group without PRP and in PRP group shapiro Wilks=0.946, P \> 0.259.~The data were normally distributed, with equal variances (Test of levene: F = 0.1234, P\> 0.99)"|Mean Difference (Final Values)|-2.452|STANDARD_ERROR_OF_MEAN|2.452|>|0.1574|TWO_SIDED|95.0|-7.332|2.428||Applies t-test for equality of means. t = -1.016 is obtained. p\> 0.1574|t-test, 1 sided|||||2.428|-7.332|>0.1574
91502260|NCT00858442|182875669|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks =0.972, P\> 0.687 in group without PRP and in PRP group shapiro Wilks = 0.964, P \> 0.410.~The data were normally distributed, with equal variances (Test of levene: F = 3.153, P\> 0.082)"|Mean Difference (Final Values)|-0.27186|STANDARD_ERROR_OF_MEAN|0.50519|>|0.593|TWO_SIDED|95.0|-1.28561|0.74189||Applies t-test for equality of means. t = -0.538 is obtained. p\> 0.593|t-test, 2 sided|||||0.74189|-1.28561|>0.593
91502261|NCT00858442|182875670|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks=0.822, P\<0.001 in group without PRP, and in PRP group shapiro Wilks =0.910, P\<0.017.~The data were no normally distributed, with equal variances (Test of levene, F=1.324, P\>0.255)"|||||>|0.398|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mean rank group without PRP= 28.88 Mean rank group with PRP= 26.31 Z value = -0.027||||||>0.398
91502262|NCT02016625|182875671|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): ratio is outside of interval (80%, 125%) vs. alternative hypothesis (H1): ratio is inside of interval (80%, 125%)|gMean ratio (%)|108.2|STANDARD_ERROR_OF_MEAN|11.5||0.0033|TWO_SIDED|90.0|99.992|117.076|||ANOVA||ratio of cyclo + FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|Geometric mean (gMean) ratio of cyclo + FDV to cyclo treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||117.076|99.992|0.0033
91502263|NCT02016625|182875672|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|106.6|STANDARD_ERROR_OF_MEAN|11.7||0.0019|TWO_SIDED|90.0|98.36|115.534|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||115.534|98.360|0.0019
91502264|NCT02016625|182875673|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|90.14|STANDARD_ERROR_OF_MEAN|16.6||0.0457|TWO_SIDED|90.0|80.281|101.205|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||101.205|80.281|0.0457
91502265|NCT02016625|182875674|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|140.98|STANDARD_ERROR_OF_MEAN|35.8||0.8122|TWO_SIDED|90.0|111.772|177.833|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||177.833|111.772|0.8122
91531617|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-8.0|0.066
91531618|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
91531619|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.4|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.40
91531620|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.24|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.24
91746453|NCT01942668|183385803|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-20.49|-5.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.46|-20.49|<0.001
91746454|NCT01942668|183385803|SUPERIORITY||Mean Difference (Final Values)|-14.28|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-21.7|-6.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.87|-21.70|<0.001
91746455|NCT01942668|183385804|SUPERIORITY||Mean Difference (Final Values)|-21.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.72|-13.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-13.29|-28.72|<0.001
91502266|NCT02016625|182875675|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|116.92|STANDARD_ERROR_OF_MEAN|11.0||0.065|TWO_SIDED|90.0|108.674|125.801|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||125.801|108.674|0.0650
91502267|NCT02016625|182875676|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|122.68|STANDARD_ERROR_OF_MEAN|23.9||0.4181|TWO_SIDED|90.0|104.8|143.6|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||143.60|104.80|0.4181
91746456|NCT01942668|183385804|SUPERIORITY||Mean Difference (Final Values)|-18.37|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.96|-10.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.78|-25.96|<0.001
91746457|NCT01942668|183385804|SUPERIORITY||Mean Difference (Final Values)|-13.03|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-20.66|-5.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.39|-20.66|<0.001
91746458|NCT01942668|183385804|SUPERIORITY||Mean Difference (Final Values)|-14.65|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-22.19|-7.12||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.12|-22.19|<0.001
91746459|NCT01942668|183385805|SUPERIORITY||Mean Difference (Final Values)|-21.83|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|-29.57|-14.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.08|-29.57|<0.001
91746460|NCT01942668|183385805|SUPERIORITY||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-27.02|-11.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.77|-27.02|<0.001
91746461|NCT01942668|183385805|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-21.65|-6.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-21.65|<0.001
91746462|NCT01942668|183385805|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-23.23|-8.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.10|-23.23|<0.001
91746463|NCT01942668|183385806|SUPERIORITY||Mean Difference (Final Values)|-20.61|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.32|-12.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.89|-28.32|<0.001
91531621|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
91531622|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.1||0.17|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.17
91746464|NCT01942668|183385806|SUPERIORITY||Mean Difference (Final Values)|-18.24|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.84|-10.65||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.65|-25.84|<0.001
91746465|NCT01942668|183385806|SUPERIORITY||Mean Difference (Final Values)|-12.62|STANDARD_ERROR_OF_MEAN|3.89||0.001|TWO_SIDED|95.0|-20.26|-4.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.98|-20.26|0.001
91746466|NCT01942668|183385806|SUPERIORITY||Mean Difference (Final Values)|-13.97|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-21.51|-6.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.43|-21.51|<0.001
91746467|NCT01942668|183385807|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.027||0.676|TWO_SIDED|95.0|-0.04|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.04|0.676
91746468|NCT01942668|183385807|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.027||0.436|TWO_SIDED|95.0|-0.03|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.03|0.436
91746469|NCT01942668|183385807|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.027||0.106|TWO_SIDED|95.0|-0.01|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.01|0.106
91502268|NCT02016625|182875677|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|127.41|STANDARD_ERROR_OF_MEAN|16.8||0.6207|TWO_SIDED|90.0|114.453|141.827|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||141.827|114.453|0.6207
91502269|NCT02016625|182875678|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|136.85|STANDARD_ERROR_OF_MEAN|22.4||0.8592|TWO_SIDED|90.0|118.683|157.793|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||157.793|118.683|0.8592
91502270|NCT02016625|182875679|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.15|STANDARD_ERROR_OF_MEAN|28.5||0.0269|TWO_SIDED|90.0|82.857|118.644|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||118.644|82.857|0.0269
91502271|NCT02016625|182875680|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|93.85|STANDARD_ERROR_OF_MEAN|25.1||0.0493|TWO_SIDED|90.0|80.059|110.022|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||110.022|80.059|0.0493
91502272|NCT02016625|182875681|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.54|STANDARD_ERROR_OF_MEAN|10.0||0|TWO_SIDED|90.0|93.375|106.115|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||106.115|93.375|0.0000
91746470|NCT01942668|183385807|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.752|TWO_SIDED|95.0|-0.06|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.06|0.752
91746471|NCT01942668|183385808|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.038||0.193|TWO_SIDED|95.0|-0.12|0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.12|0.193
91746472|NCT01942668|183385808|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.037||0.319|TWO_SIDED|95.0|-0.11|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.11|0.319
91746473|NCT01942668|183385808|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.037||0.239|TWO_SIDED|95.0|-0.03|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.03|0.239
91513607|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.63|< 0.001
91513608|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.70|< 0.001
91513609|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.71|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
91513610|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.79|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.79|0.69|< 0.001
91746474|NCT01942668|183385808|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.72|TWO_SIDED|95.0|-0.09|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.09|0.720
91746475|NCT01942668|183385809|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.049||0.03|TWO_SIDED|95.0|-0.2|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.20|0.030
91746476|NCT01942668|183385809|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.048||0.06|TWO_SIDED|95.0|-0.19|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.19|0.060
91746477|NCT01942668|183385809|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.048||0.506|TWO_SIDED|95.0|-0.06|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.13|-0.06|0.506
91746478|NCT01942668|183385809|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.048||0.232|TWO_SIDED|95.0|-0.15|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.15|0.232
91746479|NCT01942668|183385810|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.058||0.027|TWO_SIDED|95.0|-0.24|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.24|0.027
91746480|NCT01942668|183385810|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.057||0.011|TWO_SIDED|95.0|-0.26|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.26|0.011
91746481|NCT01942668|183385810|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.057||0.71|TWO_SIDED|95.0|-0.13|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.13|0.710
91746482|NCT01942668|183385810|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.057||0.072|TWO_SIDED|95.0|-0.21|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.21|0.072
91746483|NCT01942668|183385811|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.36|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.36|<0.001
91746484|NCT01942668|183385811|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.068||0.062|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.062
91746485|NCT01942668|183385811|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.068||0.886|TWO_SIDED|95.0|-0.12|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.14|-0.12|0.886
91746486|NCT01942668|183385811|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.067|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.067
91746487|NCT01942668|183385812|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
91746488|NCT01942668|183385812|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.082||0.053|TWO_SIDED|95.0|-0.32|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.32|0.053
91746489|NCT01942668|183385812|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.083||0.413|TWO_SIDED|95.0|-0.23|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.23|0.413
91746490|NCT01942668|183385812|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.018|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.018
91746491|NCT01942668|183385813|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
91746492|NCT01942668|183385813|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.083||0.006|TWO_SIDED|95.0|-0.4|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.40|0.006
91746493|NCT01942668|183385813|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.084||0.072|TWO_SIDED|95.0|-0.32|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.32|0.072
91746494|NCT01942668|183385813|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.014|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.014
91746495|NCT01942668|183385814|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
91746496|NCT01942668|183385814|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.085||0.016|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.016
91746497|NCT01942668|183385814|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.169|TWO_SIDED|95.0|-0.29|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.29|0.169
91746498|NCT01942668|183385814|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.085||0.081|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.081
91746499|NCT01942668|183385815|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
91746500|NCT01942668|183385815|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.003|TWO_SIDED|95.0|-0.45|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.10|-0.45|0.003
91746501|NCT01942668|183385815|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.091||0.022|TWO_SIDED|95.0|-0.39|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.39|0.022
91746502|NCT01942668|183385815|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.006|TWO_SIDED|95.0|-0.43|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.43|0.006
91746503|NCT01942668|183385816|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
91746504|NCT01942668|183385816|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.095||0.007|TWO_SIDED|95.0|-0.44|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.44|0.007
91746505|NCT01942668|183385816|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.095||0.038|TWO_SIDED|95.0|-0.39|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.39|0.038
91746506|NCT01942668|183385816|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.283|TWO_SIDED|95.0|-0.29|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.29|0.283
91746507|NCT01942668|183385817|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
91746508|NCT01942668|183385817|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.54|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.16|-0.54|<0.001
91746509|NCT01942668|183385817|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.098||0.027|TWO_SIDED|95.0|-0.41|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.41|0.027
91746510|NCT01942668|183385817|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.071|TWO_SIDED|95.0|-0.36|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.36|0.071
91746511|NCT01942668|183385818|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.77|-0.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.37|-0.77|<0.001
91746512|NCT01942668|183385818|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.18|-0.57|<0.001
91746513|NCT01942668|183385818|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.039|TWO_SIDED|95.0|-0.4|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.40|0.039
91746514|NCT01942668|183385818|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.099||0.088|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.088
91746515|NCT01942668|183385819|SUPERIORITY|||||||0.85||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.850
91746516|NCT01942668|183385819|SUPERIORITY|||||||0.622||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.622
91746517|NCT01942668|183385819|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||1.000
91746518|NCT01942668|183385819|SUPERIORITY|||||||0.374||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.374
91746519|NCT01942668|183385819|SUPERIORITY|||||||0.706||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.706
91746520|NCT01942668|183385819|SUPERIORITY|||||||0.372||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.372
91746521|NCT01942668|183385819|SUPERIORITY|||||||0.316||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.316
91746522|NCT01942668|183385819|SUPERIORITY|||||||0.221||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.221
91746523|NCT01942668|183385820|SUPERIORITY|||||||0.283||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.283
91746524|NCT01942668|183385820|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.004
91746525|NCT01942668|183385820|SUPERIORITY|||||||0.68||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.680
91746526|NCT01942668|183385820|SUPERIORITY|||||||0.232||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.232
91746527|NCT01942668|183385820|SUPERIORITY|||||||0.677||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.677
91746528|NCT01942668|183385820|SUPERIORITY|||||||0.073||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.073
91746529|NCT01942668|183385820|SUPERIORITY|||||||0.301||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.301
91746530|NCT01942668|183385820|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.013
91746531|NCT01942668|183385821|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.003
91746532|NCT01942668|183385821|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
91746533|NCT01942668|183385821|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.135
91746534|NCT01942668|183385821|SUPERIORITY|||||||0.231||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.231
91746535|NCT01942668|183385821|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.377
91746536|NCT01942668|183385821|SUPERIORITY|||||||0.478||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.478
91746537|NCT01942668|183385821|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.015
91746538|NCT01942668|183385821|SUPERIORITY|||||||0.1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.100
91746539|NCT01942668|183385822|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
91746540|NCT01942668|183385822|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
91746541|NCT01942668|183385822|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.009
91746542|NCT01942668|183385822|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.017
91746543|NCT01942668|183385822|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.001
91746544|NCT01942668|183385822|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.025
91746545|NCT01942668|183385822|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
91746546|NCT01942668|183385822|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
91746547|NCT01942668|183385823|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
91746548|NCT01942668|183385823|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
91746549|NCT01942668|183385823|SUPERIORITY|||||||0.066||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.066
91746550|NCT01942668|183385823|SUPERIORITY|||||||0.055||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.055
91746551|NCT01942668|183385823|SUPERIORITY|||||||0.174||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.174
91746552|NCT01942668|183385823|SUPERIORITY|||||||0.319||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.319
91746553|NCT01942668|183385823|SUPERIORITY|||||||0.007||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.007
91531623|NCT02886728|182939609|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.008|TWO_SIDED|95.0|-10.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-10.0|0.008
91746554|NCT01942668|183385823|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.008
91531624|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
91746555|NCT01942668|183385824|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
91746556|NCT01942668|183385824|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
91746557|NCT01942668|183385824|SUPERIORITY|||||||0.019||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.019
91746558|NCT01942668|183385824|SUPERIORITY|||||||0.061||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.061
91746559|NCT01942668|183385824|SUPERIORITY|||||||0.026||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.026
91746560|NCT01942668|183385824|SUPERIORITY|||||||0.104||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.104
91746561|NCT01942668|183385824|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
91746562|NCT01942668|183385824|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.018
91746563|NCT01942668|183385825|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
91746564|NCT01942668|183385825|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
91746565|NCT01942668|183385825|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
91746566|NCT01942668|183385825|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.003
91746567|NCT01942668|183385825|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.017
91746568|NCT01942668|183385825|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.025
91746569|NCT01942668|183385825|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
91746570|NCT01942668|183385825|SUPERIORITY|||||||0.037||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.037
91746571|NCT01942668|183385826|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
91746572|NCT01942668|183385826|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
91746573|NCT01942668|183385826|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
91746574|NCT01942668|183385826|SUPERIORITY|||||||0.016||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.016
91746575|NCT01942668|183385826|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.012
91746576|NCT01942668|183385826|SUPERIORITY|||||||0.053||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.053
91746577|NCT01942668|183385826|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.004
91746578|NCT01942668|183385826|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.074
91746579|NCT01942668|183385827|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
91746580|NCT01942668|183385827|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
91746581|NCT01942668|183385827|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
91746582|NCT01942668|183385827|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
91746583|NCT01942668|183385827|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.009
91746584|NCT01942668|183385827|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.004
91746585|NCT01942668|183385827|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.002
91746586|NCT01942668|183385827|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.015
91746587|NCT01942668|183385828|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.004
91746588|NCT01942668|183385828|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
91746589|NCT01942668|183385828|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.002
91746590|NCT01942668|183385828|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.001
91746591|NCT01942668|183385828|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
91746592|NCT01942668|183385828|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.009
91531625|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
91746593|NCT01942668|183385828|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.018
91746594|NCT01942668|183385828|SUPERIORITY|||||||0.021||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.021
91746595|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746596|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91746597|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746598|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91746599|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746600|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91746601|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746602|NCT01942668|183385829|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91746603|NCT01942668|183385830|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
91746604|NCT01942668|183385830|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
91746605|NCT01942668|183385830|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
91746606|NCT01942668|183385830|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
91746607|NCT01942668|183385830|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.006
91746608|NCT01942668|183385830|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.001
91746609|NCT01942668|183385830|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.015
91746610|NCT01942668|183385830|SUPERIORITY|||||||0.005||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.005
91746611|NCT01942668|183385831|SUPERIORITY|||||||0.523||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.523
91746612|NCT01942668|183385831|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
91502273|NCT02016625|182875682|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|96.16|STANDARD_ERROR_OF_MEAN|12.9||0.0008|TWO_SIDED|90.0|88.53|104.45|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||104.45|88.53|0.0008
91746613|NCT01942668|183385831|SUPERIORITY|||||||0.821||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.821
91746614|NCT01942668|183385831|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
91746615|NCT01942668|183385831|SUPERIORITY|||||||0.828||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.828
91746616|NCT01942668|183385831|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
91746617|NCT01942668|183385831|SUPERIORITY|||||||0.239||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.239
91746618|NCT01942668|183385831|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.377
91746619|NCT01942668|183385832|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.036
91746620|NCT01942668|183385832|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.015
91746621|NCT01942668|183385832|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||1.000
91746622|NCT01942668|183385832|SUPERIORITY|||||||0.546||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.546
91746623|NCT01942668|183385832|SUPERIORITY|||||||0.352||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.352
91746624|NCT01942668|183385832|SUPERIORITY|||||||0.261||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.261
91746625|NCT01942668|183385832|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.058
91746626|NCT01942668|183385832|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.011
91746627|NCT01942668|183385833|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||<0.001
91746628|NCT01942668|183385833|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
91746629|NCT01942668|183385833|SUPERIORITY|||||||0.115||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.115
91746630|NCT01942668|183385833|SUPERIORITY|||||||0.11||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.110
91746631|NCT01942668|183385833|SUPERIORITY|||||||0.089||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.089
91746632|NCT01942668|183385833|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.074
91746633|NCT01942668|183385833|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.011
91746634|NCT01942668|183385833|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.008
91746635|NCT01942668|183385834|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
91746636|NCT01942668|183385834|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
91746637|NCT01942668|183385834|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.011
91746638|NCT01942668|183385834|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
91746639|NCT01942668|183385834|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.002
91746640|NCT01942668|183385834|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.002
91746641|NCT01942668|183385834|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
91746642|NCT01942668|183385834|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
91531626|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
91531627|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
91746643|NCT01942668|183385835|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
91746644|NCT01942668|183385835|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
91746645|NCT01942668|183385835|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.048
91746646|NCT01942668|183385835|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.006
91746647|NCT01942668|183385835|SUPERIORITY|||||||0.063||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.063
91746648|NCT01942668|183385835|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.058
91746649|NCT01942668|183385835|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.004
91746650|NCT01942668|183385835|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.003
91746651|NCT01942668|183385836|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
91746652|NCT01942668|183385836|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
91746653|NCT01942668|183385836|SUPERIORITY|||||||0.05||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.050
91746654|NCT01942668|183385836|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.006
91746655|NCT01942668|183385836|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.048
91746656|NCT01942668|183385836|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.004
91746657|NCT01942668|183385836|SUPERIORITY|||||||0.02||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.020
91746658|NCT01942668|183385836|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.001
91746659|NCT01942668|183385837|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
91746660|NCT01942668|183385837|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
91746661|NCT01942668|183385837|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
91746662|NCT01942668|183385837|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
91746663|NCT01942668|183385837|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
91746664|NCT01942668|183385837|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
91746665|NCT01942668|183385837|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
91746666|NCT01942668|183385837|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
91502274|NCT02603809|182875693|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
91746667|NCT01942668|183385838|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
91746668|NCT01942668|183385838|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
91746669|NCT01942668|183385838|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.013
91746670|NCT01942668|183385838|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
91746671|NCT01942668|183385838|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
91746672|NCT01942668|183385838|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.004
91746673|NCT01942668|183385838|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.003
91746674|NCT01942668|183385838|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.001
91746675|NCT01942668|183385839|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
91746676|NCT01942668|183385839|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
91746677|NCT01942668|183385839|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
91746678|NCT01942668|183385839|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
91746679|NCT01942668|183385839|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.001
91746680|NCT01942668|183385839|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
91746681|NCT01942668|183385839|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.004
91746682|NCT01942668|183385839|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
91746683|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
91746684|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
91746685|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
91746686|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
91746687|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
91746688|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
91746689|NCT01942668|183385840|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
91746690|NCT01942668|183385840|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
91746691|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746692|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91746693|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746694|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91502275|NCT02603809|182875693|SUPERIORITY||LS Mean|-1.31|STANDARD_ERROR_OF_MEAN|1.548||0.8117|TWO_SIDED|95.0|-5.1|2.49|||ANCOVA|with Dunnett correction.||||2.49|-5.10|0.8117
91502276|NCT02603809|182875693|SUPERIORITY||LS Mean|-4.93|STANDARD_ERROR_OF_MEAN|1.532||0.0053|TWO_SIDED|95.0|-8.68|-1.17|||ANCOVA|with Dunnett correction.||||-1.17|-8.68|0.0053
91502277|NCT02603809|182875693|SUPERIORITY||LS Mean|-6.99|STANDARD_ERROR_OF_MEAN|1.554|<|0.0001|TWO_SIDED|95.0|-10.8|-3.19|||ANCOVA|with Dunnett correction.||||-3.19|-10.80|<.0001
91502278|NCT02603809|182875693|SUPERIORITY||LS Mean|-4.95|STANDARD_ERROR_OF_MEAN|1.549||0.0057|TWO_SIDED|95.0|-8.75|-1.15|||ANCOVA|with Dunnett correction.||||-1.15|-8.75|0.0057
91502279|NCT02603809|182875694|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran-rprojects.org/web/packages/DoseFinding.)"||||<0.001
91531628|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
91502280|NCT02603809|182875694|SUPERIORITY||LS Mean|-2.45|STANDARD_ERROR_OF_MEAN|2.445||0.7071|TWO_SIDED|95.0|-8.44|3.54|||ANCOVA|with Dunnett correction.||||3.54|-8.44|0.7071
91531629|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
91746695|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746696|NCT01942668|183385841|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||0.003
91746697|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
91746698|NCT01942668|183385841|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
91746699|NCT01942668|183385842|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
91746700|NCT01942668|183385842|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
91746701|NCT01942668|183385842|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
91746702|NCT01942668|183385842|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
91746703|NCT01942668|183385842|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
91746704|NCT01942668|183385842|SUPERIORITY|||||||0.056||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.056
91746705|NCT01942668|183385842|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
91746706|NCT01942668|183385842|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.017
91746707|NCT01942668|183385843|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||<0.001
91746708|NCT01942668|183385843|SUPERIORITY|||||||0.005||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||0.005
91502281|NCT02603809|182875694|SUPERIORITY||LS Mean|-7.05|STANDARD_ERROR_OF_MEAN|2.42||0.0138|TWO_SIDED|95.0|-12.98|-1.12|||ANCOVA|with Dunnett correction.||||-1.12|-12.98|0.0138
91502282|NCT02603809|182875694|SUPERIORITY||LS Mean|-9.9|STANDARD_ERROR_OF_MEAN|2.457||0.0003|TWO_SIDED|95.0|-15.92|-3.88|||ANCOVA|with Dunnett correction.||||-3.88|-15.92|0.0003
91502283|NCT02603809|182875694|SUPERIORITY||LS Mean|-7.58|STANDARD_ERROR_OF_MEAN|0.0077||0.0077|TWO_SIDED|95.0|-13.58|-1.59|||ANCOVA|with Dunnett correction.||||-1.59|-13.58|0.0077
91502284|NCT02603809|182875700|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
91502285|NCT02603809|182875700|SUPERIORITY||LS Mean|-1.75|STANDARD_ERROR_OF_MEAN|1.401||0.5356|TWO_SIDED|95.0|-5.19|1.69|||ANCOVA|with Dunnett correction.||||1.69|-5.19|0.5356
91502286|NCT02603809|182875700|SUPERIORITY||LS Mean|-5.82|STANDARD_ERROR_OF_MEAN|1.396||0.0001|TWO_SIDED|95.0|-9.25|-2.4|||ANCOVA|with Dunnett correction.||||-2.40|-9.25|0.0001
91502287|NCT02603809|182875700|SUPERIORITY||LS Mean|-7.5|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-10.96|-4.04|||ANCOVA|with Dunnett correction.||||-4.04|-10.96|<.0001
91502288|NCT02603809|182875700|SUPERIORITY||LS Mean|-5.65|STANDARD_ERROR_OF_MEAN|1.41||0.0003|TWO_SIDED|95.0|-9.11|-2.19|||ANCOVA|with Dunnett correction.||||-2.19|-9.11|0.0003
91502289|NCT00380978|182875714|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence|Risk Ratio (RR)|1.04||||0.65|TWO_SIDED|95.0|0.9|1.2|||Chi-squared, Corrected|||Group sample sizes of 800 in each group achieve 80% power to detect equivalence when the margin of equivalence extends from 0.1 to 0.25||1.20|0.90|0.65
91502290|NCT00380978|182875715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||0.63|TWO_SIDED|95.0|0.8|1.2|||Chi-squared|||There rate of instrumented vaginal delivery will be equal in both groups.||1.20|0.80|0.63
91502291|NCT00380978|182875716|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Log Rank|||||||0.047
91502292|NCT00380978|182875717|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Chi-squared|||||||0.35
91502293|NCT00380978|182875718|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0|||<|0.005|TWO_SIDED|95.0|-4.0|-3.0|||Wilcoxon (Mann-Whitney)|||||-3|-4|<0.005
91531630|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
91531631|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
91746709|NCT01942668|183385843|SUPERIORITY|||||||0.007||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.007
91746710|NCT01942668|183385843|SUPERIORITY|||||||0.004||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.004
91746711|NCT01942668|183385845|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
91531632|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.001|TWO_SIDED|95.0|-8.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-8.0|0.001
91746712|NCT01942668|183385845|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
91746713|NCT01942668|183385845|SUPERIORITY|||||||0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.001
91746714|NCT01942668|183385845|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.002
91746715|NCT01942668|183385847|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
91502294|NCT00380978|182875719|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
91502295|NCT00380978|182875720|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
91502296|NCT00380978|182875721|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
91502297|NCT02981342|182875745|SUPERIORITY|||||||0.0495|||||||Cochran-Mantel-Haenszel|||||||0.0495
91502298|NCT02981342|182875745|SUPERIORITY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.0230
91502299|NCT02981342|182875746|SUPERIORITY|||||||0.0085|||||||Log Rank|||||||0.0085
91502300|NCT02981342|182875746|SUPERIORITY|||||||0.0123|||||||Log Rank|||||||0.0123
91502301|NCT02981342|182875747|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
91502302|NCT02981342|182875747|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
91502303|NCT02981342|182875752|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
91502304|NCT02981342|182875752|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
91502305|NCT02981342|182875754|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.1938|TWO_SIDED|95.0|0.782|3.272|||Log Rank|||||3.272|0.782|0.1938
91502306|NCT02981342|182875754|SUPERIORITY||Hazard Ratio (HR)|1.533||||0.2477|TWO_SIDED|95.0|0.746|3.15|||Log Rank|||||3.150|0.746|0.2477
91502307|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.74||0.383|TWO_SIDED|95.0|-0.84|2.13|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||2.13|-0.84|0.383
91502308|NCT02981342|182875756|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.79||0.692|TWO_SIDED|95.0|-1.91|1.28|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||1.28|-1.91|0.692
91502309|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.66||0.469|TWO_SIDED|95.0|-0.85|1.8|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.80|-0.85|0.469
91502310|NCT02981342|182875756|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.776|TWO_SIDED|95.0|-1.62|1.22|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.22|-1.62|0.776
91746716|NCT01942668|183385847|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
91746717|NCT01942668|183385847|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
91502311|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.7||0.328|TWO_SIDED|95.0|-0.72|2.11|||Mixed Models Analysis|||Pain on the Average||2.11|-0.72|0.328
91502312|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.74||0.954|TWO_SIDED|95.0|-1.45|1.54|||Mixed Models Analysis|||Pain on the Average||1.54|-1.45|0.954
91502313|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.8||0.35|TWO_SIDED|95.0|-0.85|2.36|||Mixed Models Analysis|||Pain Right Now||2.36|-0.85|0.350
91502314|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.85||0.405|TWO_SIDED|95.0|-1.01|2.44|||Mixed Models Analysis|||Pain right now.||2.44|-1.01|0.405
91502315|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.73||0.565|TWO_SIDED|95.0|-1.06|1.91|||Mixed Models Analysis|||Pain Interfered General Activity||1.91|-1.06|0.565
91502316|NCT02981342|182875756|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.79||0.848|TWO_SIDED|95.0|-1.74|1.43|||Mixed Models Analysis|||Pain Interfered General Activity||1.43|-1.74|0.848
91502317|NCT02981342|182875756|SUPERIORITY||LSMean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.65||0.928|TWO_SIDED|95.0|-1.37|1.25|||Mixed Models Analysis|||Pain Interfered with Mood||1.25|-1.37|0.928
91502318|NCT02981342|182875756|SUPERIORITY||LSMean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.69||0.65|TWO_SIDED|95.0|-1.71|1.08|||Mixed Models Analysis|||Pain Interfered with Mood||1.08|-1.71|0.650
91746718|NCT01942668|183385847|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||0.002
91502319|NCT02981342|182875756|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.865|TWO_SIDED|95.0|-1.89|1.6|||Mixed Models Analysis|||Pain Interfered Walking Ability||1.60|-1.89|0.865
91746719|NCT01942668|183385849|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
91746720|NCT01942668|183385849|SUPERIORITY|||||||0.122|||||||Fisher Exact|||||||0.122
91746721|NCT01942668|183385849|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.280
91746722|NCT01942668|183385849|SUPERIORITY|||||||0.692|||||||Fisher Exact|||||||0.692
91502320|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.92||0.497|TWO_SIDED|95.0|-1.23|2.5|||Mixed Models Analysis|||Pain Interfered Walking Ability||2.50|-1.23|0.497
91502321|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.8||0.272|TWO_SIDED|95.0|-0.72|2.5|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.50|-0.72|0.272
91502322|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.85||0.583|TWO_SIDED|95.0|-1.25|2.19|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.19|-1.25|0.583
91502323|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.82||0.876|TWO_SIDED|95.0|-1.53|1.79|||Mixed Models Analysis|||Pain Interfered with Relations||1.79|-1.53|0.876
91502324|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.88||0.644|TWO_SIDED|95.0|-1.37|2.19|||Mixed Models Analysis|||Pain Interfered with relations.||2.19|-1.37|0.644
91502325|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.85||0.384|TWO_SIDED|95.0|-0.97|2.48|||Mixed Models Analysis|||Pain Interfered with Sleep||2.48|-0.97|0.384
91502326|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.89||0.318|TWO_SIDED|95.0|-0.9|2.71|||Mixed Models Analysis|||||2.71|-0.90|0.318
91502327|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.97||0.407|TWO_SIDED|95.0|-1.15|2.78|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.78|-1.15|0.407
91502328|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.52|STANDARD_ERROR_OF_MEAN|1.04||0.62|TWO_SIDED|95.0|-1.58|2.62|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.62|-1.58|0.620
91502329|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.475|TWO_SIDED|95.0|-0.9|1.91|||Mixed Models Analysis|||BPI-Mean Interference Score||1.91|-0.90|0.475
91502330|NCT02981342|182875756|SUPERIORITY||LSMean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.74||0.54|TWO_SIDED|95.0|-1.04|1.96|||Mixed Models Analysis|||BPI-Mean Interference Score||1.96|-1.04|0.540
91502331|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-1.39|STANDARD_ERROR_OF_MEAN|5.98||0.818|TWO_SIDED|95.0|-13.46|10.68|||Mixed Models Analysis|||Global health status||10.68|-13.46|0.818
91502332|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.06||0.533|TWO_SIDED|95.0|-16.03|8.42|||Mixed Models Analysis|||Global health status||8.42|-16.03|0.533
91502333|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|6.75||0.681|TWO_SIDED|95.0|-16.4|10.82|||Mixed Models Analysis|||Functional Scales: Physical functioning||10.82|-16.40|0.681
91502334|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-9.02|STANDARD_ERROR_OF_MEAN|6.75||0.189|TWO_SIDED|95.0|-22.63|4.59|||Mixed Models Analysis|||Functional Scales: Physical functioning||4.59|-22.63|0.189
91502335|NCT02981342|182875757|SUPERIORITY||LSMean Difference|0.96|STANDARD_ERROR_OF_MEAN|9.54||0.921|TWO_SIDED|95.0|-18.29|20.21|||Mixed Models Analysis|||Functional Scales: Role functioning||20.21|-18.29|0.921
91502336|NCT02981342|182875757|SUPERIORITY||LSMean Difference|0.01|STANDARD_ERROR_OF_MEAN|9.62||0.999|TWO_SIDED|95.0|-19.4|19.42|||Mixed Models Analysis|||Functional Scales: Role functioning.||19.42|-19.40|0.999
91502337|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-4.26|STANDARD_ERROR_OF_MEAN|6.91||0.541|TWO_SIDED|95.0|-18.2|9.68|||Mixed Models Analysis|||Functional Scales: Emotional functioning||9.68|-18.20|0.541
91746723|NCT01942668|183385850|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
91746724|NCT01942668|183385850|SUPERIORITY|||||||0.069|||||||Fisher Exact|||||||0.069
91746725|NCT01942668|183385850|SUPERIORITY|||||||0.131|||||||Fisher Exact|||||||0.131
91746726|NCT01942668|183385850|SUPERIORITY|||||||0.661|||||||Fisher Exact|||||||0.661
91746727|NCT01942668|183385851|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
91746728|NCT01942668|183385851|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.040
91746729|NCT01942668|183385851|SUPERIORITY|||||||0.082|||||||Fisher Exact|||||||0.082
91746730|NCT01942668|183385851|SUPERIORITY|||||||0.495|||||||Fisher Exact|||||||0.495
91746731|NCT01942668|183385852|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
91746732|NCT01942668|183385852|SUPERIORITY|||||||0.032|||||||Fisher Exact|||||||0.032
91746733|NCT01942668|183385852|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
91502338|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-6.95|STANDARD_ERROR_OF_MEAN|7.05||0.33|TWO_SIDED|95.0|-21.17|7.27|||Mixed Models Analysis|||Functional Scales: Emotional functioning||7.27|-21.17|0.330
91502339|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-2.04|STANDARD_ERROR_OF_MEAN|6.29||0.747|TWO_SIDED|95.0|-14.74|10.66|||Mixed Models Analysis|||Functional Scales: Cognitive Functioning||10.66|-14.74|0.747
91531633|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
91746734|NCT01942668|183385852|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
91746735|NCT01942668|183385853|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
91746736|NCT01942668|183385853|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
91746737|NCT01942668|183385853|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.260
91746738|NCT01942668|183385853|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
91746739|NCT01942668|183385854|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
91746740|NCT01942668|183385854|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
91746741|NCT01942668|183385854|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
91746742|NCT01942668|183385854|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746743|NCT01942668|183385855|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91746744|NCT01942668|183385855|SUPERIORITY|||||||0.075|||||||Fisher Exact|||||||0.075
91746745|NCT01942668|183385855|SUPERIORITY|||||||0.225|||||||Fisher Exact|||||||0.225
91746746|NCT01942668|183385855|SUPERIORITY|||||||0.769|||||||Fisher Exact|||||||0.769
91746747|NCT01942668|183385856|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
91746748|NCT01942668|183385856|SUPERIORITY|||||||0.084|||||||Fisher Exact|||||||0.084
91746749|NCT01942668|183385856|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
91502340|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-5.25|STANDARD_ERROR_OF_MEAN|6.43||0.419|TWO_SIDED|95.0|-18.22|7.73|||Mixed Models Analysis|||Functional Scales: Cognitive functioning||7.73|-18.22|0.419
91502341|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-4.02|STANDARD_ERROR_OF_MEAN|7.53||0.596|TWO_SIDED|95.0|-19.23|11.19|||Mixed Models Analysis|||Functional Scales: Social functioning||11.19|-19.23|0.596
91502342|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-19.12|STANDARD_ERROR_OF_MEAN|7.71||0.017|TWO_SIDED|95.0|-34.68|-3.55|||Mixed Models Analysis|||Functional Scales: Social functioning||-3.55|-34.68|0.017
91746750|NCT01942668|183385856|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
91746751|NCT01942668|183385857|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
91746752|NCT01942668|183385857|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
91746753|NCT01942668|183385857|SUPERIORITY|||||||0.386|||||||Fisher Exact|||||||0.386
91746754|NCT01942668|183385857|SUPERIORITY|||||||0.737|||||||Fisher Exact|||||||0.737
91746755|NCT01942668|183385858|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
91746756|NCT01942668|183385858|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
91746757|NCT01942668|183385858|SUPERIORITY|||||||0.745|||||||Fisher Exact|||||||0.745
91746758|NCT01942668|183385858|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746759|NCT01942668|183385859|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
91746760|NCT01942668|183385859|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
91746761|NCT01942668|183385859|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746762|NCT01942668|183385859|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746763|NCT01942668|183385860|SUPERIORITY|||||||0.261|||||||Fisher Exact|||||||0.261
91746764|NCT01942668|183385860|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
91746765|NCT01942668|183385860|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746766|NCT01942668|183385860|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746767|NCT01942668|183385861|SUPERIORITY|||||||0.463|||||||Fisher Exact|||||||0.463
91746768|NCT01942668|183385861|SUPERIORITY|||||||0.687|||||||Fisher Exact|||||||0.687
91746769|NCT01942668|183385861|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746770|NCT01942668|183385861|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746771|NCT01942668|183385862|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746772|NCT01942668|183385862|SUPERIORITY|||||||0.048|||||||Fisher Exact|||||||0.048
91746773|NCT01942668|183385862|SUPERIORITY|||||||0.049|||||||Fisher Exact|||||||0.049
91746774|NCT01942668|183385862|SUPERIORITY|||||||0.328|||||||Fisher Exact|||||||0.328
91746775|NCT01942668|183385863|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746776|NCT01942668|183385863|SUPERIORITY|||||||0.123|||||||Fisher Exact|||||||0.123
91746777|NCT01942668|183385863|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.030
91746778|NCT01942668|183385863|SUPERIORITY|||||||0.649|||||||Fisher Exact|||||||0.649
91746779|NCT01942668|183385864|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746780|NCT01942668|183385864|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
91746781|NCT01942668|183385864|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
91746782|NCT01942668|183385864|SUPERIORITY|||||||0.426|||||||Fisher Exact|||||||0.426
91746783|NCT01942668|183385865|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91502343|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|7.57||0.919|TWO_SIDED|95.0|-16.03|14.49||Social Scales: Fatigue|Mixed Models Analysis|||Symptoms Scales: Fatigue||14.49|-16.03|0.919
91746784|NCT01942668|183385865|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
91502344|NCT02981342|182875757|SUPERIORITY||LSMean Difference|8.48|STANDARD_ERROR_OF_MEAN|7.54||0.267|TWO_SIDED|95.0|-6.72|23.69|||Mixed Models Analysis|||Symptom Scales: Fatigue||23.69|-6.72|0.267
91502345|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-1.45|STANDARD_ERROR_OF_MEAN|8.54||0.866|TWO_SIDED|95.0|-18.66|15.77|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||15.77|-18.66|0.866
91746785|NCT01942668|183385865|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
91746786|NCT01942668|183385865|SUPERIORITY|||||||0.481|||||||Fisher Exact|||||||0.481
91746787|NCT01942668|183385866|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746788|NCT01942668|183385866|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.110
91746789|NCT01942668|183385866|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
91746790|NCT01942668|183385866|SUPERIORITY|||||||0.853|||||||Fisher Exact|||||||0.853
91746791|NCT01942668|183385867|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746792|NCT01942668|183385867|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
91746793|NCT01942668|183385867|SUPERIORITY|||||||0.145|||||||Fisher Exact|||||||0.145
91746794|NCT01942668|183385867|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746795|NCT01942668|183385868|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746796|NCT01942668|183385868|SUPERIORITY|||||||0.163|||||||Fisher Exact|||||||0.163
91746797|NCT01942668|183385868|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
91746798|NCT01942668|183385868|SUPERIORITY|||||||0.693|||||||Fisher Exact|||||||0.693
91746799|NCT01942668|183385869|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746800|NCT01942668|183385869|SUPERIORITY|||||||0.178|||||||Fisher Exact|||||||0.178
91746801|NCT01942668|183385869|SUPERIORITY|||||||0.097|||||||Fisher Exact|||||||0.097
91746802|NCT01942668|183385869|SUPERIORITY|||||||0.522|||||||Fisher Exact|||||||0.522
91746803|NCT01942668|183385870|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746804|NCT01942668|183385870|SUPERIORITY|||||||0.315|||||||Fisher Exact|||||||0.315
91746805|NCT01942668|183385870|SUPERIORITY|||||||0.181|||||||Fisher Exact|||||||0.181
91746806|NCT01942668|183385870|SUPERIORITY|||||||0.821|||||||Fisher Exact|||||||0.821
91746807|NCT01942668|183385871|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91746808|NCT01942668|183385871|SUPERIORITY|||||||0.387|||||||Fisher Exact|||||||0.387
91746809|NCT01942668|183385871|SUPERIORITY|||||||0.215|||||||Fisher Exact|||||||0.215
91746810|NCT01942668|183385871|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
91746811|NCT01942668|183385872|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
91746812|NCT01942668|183385872|SUPERIORITY|||||||0.643|||||||Fisher Exact|||||||0.643
91746813|NCT01942668|183385872|SUPERIORITY|||||||0.501|||||||Fisher Exact|||||||0.501
91746814|NCT01942668|183385872|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746815|NCT01942668|183385873|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
91746816|NCT01942668|183385873|SUPERIORITY|||||||0.616|||||||Fisher Exact|||||||0.616
91746817|NCT01942668|183385873|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
91746818|NCT01942668|183385873|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91746819|NCT01942668|183385874|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
91746820|NCT01942668|183385874|SUPERIORITY|||||||0.535|||||||Fisher Exact|||||||0.535
91746821|NCT01942668|183385874|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
91746822|NCT01942668|183385874|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
91746823|NCT01942668|183385875|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||<0.001
91746824|NCT01942668|183385875|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.004
91746825|NCT01942668|183385875|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.012
91746826|NCT01942668|183385875|SUPERIORITY|||||||0.032||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.032
91746827|NCT01942668|183385876|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
91746828|NCT01942668|183385876|SUPERIORITY|||||||0.022||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.022
91746829|NCT01942668|183385876|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.004
91746830|NCT01942668|183385876|SUPERIORITY|||||||0.256||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.256
91746831|NCT01942668|183385877|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||<0.001
91746832|NCT01942668|183385877|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.006
91746833|NCT01942668|183385877|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.025
91746834|NCT01942668|183385877|SUPERIORITY|||||||0.182||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.182
91746835|NCT01942668|183385878|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.002
91502346|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.59||0.652|TWO_SIDED|95.0|-21.23|13.43|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||13.43|-21.23|0.652
91502347|NCT02981342|182875757|SUPERIORITY||LSMean Difference|7.11|STANDARD_ERROR_OF_MEAN|8.67||0.417|TWO_SIDED|95.0|-10.39|24.6|||Mixed Models Analysis|||Symptom Scales: Pain||24.60|-10.39|0.417
91502348|NCT02981342|182875757|SUPERIORITY||LSMean Difference|4.36|STANDARD_ERROR_OF_MEAN|8.69||0.618|TWO_SIDED|95.0|-13.16|21.89|||Mixed Models Analysis|||Symptom Scales: Pain||21.89|-13.16|0.618
91502349|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-10.84|STANDARD_ERROR_OF_MEAN|8.44||0.206|TWO_SIDED|95.0|-27.85|6.18|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||6.18|-27.85|0.206
91502350|NCT02981342|182875757|SUPERIORITY||LSMean Difference|4.86|STANDARD_ERROR_OF_MEAN|8.4||0.566|TWO_SIDED|95.0|-12.08|21.8|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||21.80|-12.08|0.566
91502351|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-7.02|STANDARD_ERROR_OF_MEAN|7.93||0.38|TWO_SIDED|95.0|-23.01|8.96|||Mixed Models Analysis|||Symptom Scales: Insomnia||8.96|-23.01|0.380
91502352|NCT02981342|182875757|SUPERIORITY||LSMean Difference|1.52|STANDARD_ERROR_OF_MEAN|7.99||0.85|TWO_SIDED|95.0|-14.6|17.64|||Mixed Models Analysis|||Symptom Scales: Insomnia||17.64|-14.60|0.850
91502353|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|8.91||0.756|TWO_SIDED|95.0|-20.78|15.21|||Mixed Models Analysis|||Symptom Scales: Appetite loss||15.21|-20.78|0.756
91502354|NCT02981342|182875757|SUPERIORITY||LSMean Difference|3.02|STANDARD_ERROR_OF_MEAN|9.31||0.747|TWO_SIDED|95.0|-15.77|21.82|||Mixed Models Analysis|||Symptom Scales: Appetite loss||21.82|-15.77|0.747
91746836|NCT01942668|183385878|SUPERIORITY|||||||0.469||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.469
91746837|NCT01942668|183385878|SUPERIORITY|||||||0.188||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.188
91746838|NCT01942668|183385878|SUPERIORITY|||||||0.613||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.613
91746839|NCT01942668|183385883|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.002
91746840|NCT01942668|183385883|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.135
91746841|NCT01942668|183385883|SUPERIORITY|||||||0.26||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.260
91502355|NCT02981342|182875757|SUPERIORITY||LSMean Difference|9.47|STANDARD_ERROR_OF_MEAN|9.23||0.311|TWO_SIDED|95.0|-9.16|28.09|||Mixed Models Analysis|||Symptom Scales: Constipation||28.09|-9.16|0.311
91502356|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-9.97|STANDARD_ERROR_OF_MEAN|9.3||0.29|TWO_SIDED|95.0|-28.75|8.8|||Mixed Models Analysis|||Symptom Scales: Constipation||8.80|-28.75|0.290
91502357|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-10.57|STANDARD_ERROR_OF_MEAN|10.58||0.323|TWO_SIDED|95.0|-31.93|10.78|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||10.78|-31.93|0.323
91502358|NCT02981342|182875757|SUPERIORITY||LSMean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.54||0.651|TWO_SIDED|95.0|-26.08|16.48|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||16.48|-26.08|0.651
91502359|NCT02981342|182875757|SUPERIORITY||LSMean Difference|1.51|STANDARD_ERROR_OF_MEAN|7.47||0.841|TWO_SIDED|95.0|-13.57|16.59|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||16.59|-13.57|0.841
91502360|NCT02981342|182875757|SUPERIORITY||LSMean Difference|7.26|STANDARD_ERROR_OF_MEAN|7.57||0.344|TWO_SIDED|95.0|-8.03|22.54|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||22.54|-8.03|0.344
91502361|NCT01277523|182875815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.055||0.0457|TWO_SIDED|95.0|0.002|0.22||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.220|0.002|0.0457
91502362|NCT01277523|182875815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.055||0.1039|TWO_SIDED|95.0|-0.019|0.198||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.198|-0.019|0.1039
91502363|NCT01277523|182875816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.059||0.0509|TWO_SIDED|95.0|0.0|0.231||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.231|-0.000|0.0509
91502364|NCT01277523|182875816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.058||0.3605|TWO_SIDED|95.0|-0.061|0.168||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.061|0.3605
91502365|NCT01277523|182875817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.059||0.1264|TWO_SIDED|95.0|-0.026|0.207|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.207|-0.026|0.1264
91502366|NCT01277523|182875817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.059||0.2845|TWO_SIDED|95.0|-0.053|0.179|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.179|-0.053|0.2845
91502367|NCT01277523|182875818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.053||0.0338|TWO_SIDED|95.0|0.009|0.217|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.217|0.009|0.0338
91746842|NCT01942668|183385883|SUPERIORITY|||||||0.257||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.257
91746843|NCT01942668|183385884|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
91746844|NCT01942668|183385884|SUPERIORITY|||||||0.085||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.085
91502368|NCT01277523|182875818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.053||0.0999|TWO_SIDED|95.0|-0.017|0.191|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.191|-0.017|0.0999
91502369|NCT01277523|182875819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.057||0.1252|TWO_SIDED|95.0|-0.024|0.198|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.198|-0.024|0.1252
91502370|NCT01277523|182875819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.056||0.3549|TWO_SIDED|95.0|-0.058|0.163|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.163|-0.058|0.3549
91502371|NCT01277523|182875820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.088||0.1819|TWO_SIDED|95.0|-0.055|0.292|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.292|-0.055|0.1819
91502372|NCT01277523|182875820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.088||0.5448|TWO_SIDED|95.0|-0.119|0.226|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.226|-0.119|0.5448
91502373|NCT01277523|182875822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.082||0.4762|TWO_SIDED|95.0|-0.102|0.219|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.219|-0.102|0.4762
91502374|NCT01277523|182875822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.081||0.6558|TWO_SIDED|95.0|-0.123|0.196|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.196|-0.123|0.6558
91502375|NCT01277523|182875824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.153||0.996|TWO_SIDED|95.0|-0.301|0.3|||Mixed Models Analysis|||||0.300|-0.301|0.9960
91502376|NCT01277523|182875824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.151||0.703|TWO_SIDED|95.0|-0.355|0.239|||Mixed Models Analysis|||||0.239|-0.355|0.7030
91502377|NCT01277523|182875825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.094||0.7309|TWO_SIDED|95.0|-0.217|0.153|||Mixed Models Analysis|||||0.153|-0.217|0.7309
91502378|NCT01277523|182875825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.093||0.5954|TWO_SIDED|95.0|-0.232|0.133|||Mixed Models Analysis|||||0.133|-0.232|0.5954
91502379|NCT01277523|182875826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.083||0.2841|TWO_SIDED|95.0|-0.074|0.252|||Mixed Models Analysis|||||0.252|-0.074|0.2841
91746845|NCT01942668|183385884|SUPERIORITY|||||||0.184||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.184
91502380|NCT01277523|182875826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.082||0.795|TWO_SIDED|95.0|-0.14|0.182|||Mixed Models Analysis|||||0.182|-0.140|0.7950
91502381|NCT01277523|182875827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.9671|TWO_SIDED|95.0|0.07|16.95|||Regression, Cox|||||16.95|0.07|0.9671
91502382|NCT01277523|182875827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.5557|TWO_SIDED|95.0|0.19|22.7|||Regression, Cox|||||22.70|0.19|0.5557
91502383|NCT01277523|182875828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.3567|TWO_SIDED|95.0|0.41|1.38|||Regression, Cox|||||1.38|0.41|0.3567
91502384|NCT01277523|182875828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1168|TWO_SIDED|95.0|0.32|1.14|||Regression, Cox|||||1.14|0.32|0.1168
91502385|NCT00112502|182875834|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.7||||||||1.7|0.8|
91502386|NCT00112502|182875835|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.6|1.2||||||||1.2|0.6|
91502387|NCT00112502|182875836|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.8||||||||1.8|0.9|
91502388|NCT00112502|182875837|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.3||||||||1.3|0.6|
91502389|NCT00112502|182875839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5||||||||1.5|0.7|
91502390|NCT00112502|182875840|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
91502391|NCT00112502|182875841|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.8||||||||1.8|0.8|
91502392|NCT00112502|182875842|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1||||||||1.1|0.5|
91502393|NCT02094716|182875926|SUPERIORITY|||||||0.6084|||||||Chi-squared|||||||0.6084
91502394|NCT02094716|182875928|SUPERIORITY|||||||0.6937|||||||Chi-squared|||||||0.6937
91502395|NCT02094716|182875929|SUPERIORITY|||||||0.101|||||||Fisher Exact|||||||0.1010
91502396|NCT02094716|182875929|SUPERIORITY|||||||0.0764|||||||Fisher Exact|||||||0.0764
91502397|NCT01203046|182875961|NON_INFERIORITY_OR_EQUIVALENCE|It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.|Odds Ratio (OR)|2.65|||<|0.05|TWO_SIDED|95.0|0.35|19.83|||Regression, Logistic|||||19.83|0.35|<0.05
91502398|NCT01203046|182875962|NON_INFERIORITY_OR_EQUIVALENCE|Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.|Odds Ratio (OR)|1.18|||<|0.05|TWO_SIDED|95.0|0.21|6.51|||Regression, Logistic|||||6.51|0.21|<0.05
91502399|NCT03814746|182875963|SUPERIORITY||Rate ratio|1.08|||>|0.999|TWO_SIDED|95.0|0.76|1.55|||negative binomial regression model|||||1.55|0.76|> 0.999
91502400|NCT03814746|182875963|SUPERIORITY||Rate ratio|0.89|||>|0.999|TWO_SIDED|95.0|0.62|1.27|||negative binomial regression model|||||1.27|0.62|> 0.999
91502401|NCT03814746|182875964|SUPERIORITY||Rate ratio|1.21|||||TWO_SIDED|95.0|0.87|1.7|||negative binomial regression model|||||1.70|0.87|
91502402|NCT03814746|182875964|SUPERIORITY||Rate ratio|0.83|||||TWO_SIDED|95.0|0.59|1.17|||negative binomial regression model|||||1.17|0.59|
91502403|NCT03814746|182875969|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.92|1.97|||Cox Model|for time to first occurrence of VOC||||1.97|0.92|
91502404|NCT03814746|182875969|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.58|||Cox Model|for time to first occurrence of VOC||||1.58|0.72|
91502405|NCT03814746|182875969|SUPERIORITY|for time to second occurrence of VOC|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.81|2.04|||Cox Model|||||2.04|0.81|
91502406|NCT03814746|182875969|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.59|1.54|||Cox Model|for time to second occurrence of VOC||||1.54|0.59|
91502407|NCT03814746|182875970|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.75|1.43|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.43|0.75|
91502408|NCT03814746|182875970|SUPERIORITY||Rate ratio|0.82|||||TWO_SIDED|95.0|0.59|1.14|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.14|0.59|
91502409|NCT03814746|182875970|SUPERIORITY||Rate ratio|1.11|||||TWO_SIDED|95.0|0.77|1.59|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.59|0.77|
91502410|NCT03814746|182875970|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.6|1.25|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.25|0.60|
91502411|NCT03814746|182875971|SUPERIORITY||Rate ratio|1.34|||||TWO_SIDED|95.0|0.85|2.09|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||2.09|0.85|
91502412|NCT03814746|182875971|SUPERIORITY||Rate ratio|0.88|||||TWO_SIDED|95.0|0.57|1.38|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||1.38|0.57|
91502413|NCT03814746|182875971|SUPERIORITY||Rate ratio|1.27|||||TWO_SIDED|95.0|0.77|2.09|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||2.09|0.77|
91502414|NCT03814746|182875971|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.52|1.44|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.44|0.52|
91502415|NCT01817725|182876040|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91502416|NCT00909779|182876042|NON_INFERIORITY_OR_EQUIVALENCE|"The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).~The non-inferiority margin for the hazard ratio is 1.4."|Hazard Ratio (HR)|0.606|||||TWO_SIDED|95.0|0.425|0.864|||Regression, Cox||Hazard ratio was calculated as arformoterol vs. placebo.|"The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).~The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated."||0.864|0.425|
91502417|NCT00561080|182876085|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|Geometric Mean Titer Ratio (GMTR)|1.11||||0.948|TWO_SIDED|95.0|1.02|1.22|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||1.22|1.02|0.948
91502418|NCT00561080|182876085|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|GMTR|0.78|||>|0.999|TWO_SIDED|95.0|0.73|0.85|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||0.85|0.73|>0.999
91502419|NCT00561080|182876086|SUPERIORITY_OR_OTHER||GMFR|2.35|||||TWO_SIDED|95.0|2.11|2.62|||||GMFR=GMT Post Dose/GMT Pre Dose|||2.62|2.11|
91502420|NCT00561080|182876088|SUPERIORITY_OR_OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.96|1.17|||||GMT Ratio = Group 2 GMT/Group 1 GMT|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.17|0.96|
91502421|NCT00561080|182876088|SUPERIORITY_OR_OTHER||GMT Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||GMT Ratio = GMT Group 3/GMT Group 1|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.19|0.98|
91502422|NCT02295995|182876109|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
91502423|NCT02295995|182876110|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
91502424|NCT02295995|182876111|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
91502425|NCT04262232|182876119|SUPERIORITY||Mean Difference (Net)|-1.8||||0.0001|TWO_SIDED|95.0|-2.6|-0.95|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.95|-2.6|0.0001
91502426|NCT04262232|182876120|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.17|1.63|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||1.63|1.17|<0.0001
91502427|NCT04262232|182876122|SUPERIORITY||Mean Difference (Net)|-2.8||||0.01|TWO_SIDED|95.0|-4.99|-0.61|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.61|-4.99|0.01
91502428|NCT04262232|182876124|SUPERIORITY||Mean Difference (Net)|0.5||||0.51|TWO_SIDED|95.0|-1.02|2.02|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||2.02|-1.02|0.51
91746846|NCT01942668|183385884|SUPERIORITY|||||||0.681||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.681
91746847|NCT01942668|183385885|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.008
91502429|NCT01975909|182876125|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.||||||0.29|||||||t-test, 2 sided|||||||0.29
91502430|NCT01975909|182876126|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.47|||||||t-test, 2 sided|||||||0.47
91746848|NCT01942668|183385885|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.036
91746849|NCT01942668|183385885|SUPERIORITY|||||||0.138||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.138
91746850|NCT01942668|183385885|SUPERIORITY|||||||0.685||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.685
91502431|NCT01975909|182876127|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.||||||0.12|||||||t-test, 2 sided|||||||0.12
91502432|NCT01975909|182876128|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.69|||||||t-test, 2 sided|||||||0.69
91502433|NCT01975909|182876129|EQUIVALENCE|We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.||||||0.009|||||||t-test, 2 sided|||||||0.009
91746851|NCT01942668|183385886|SUPERIORITY|||||||0.023||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.023
91746852|NCT01942668|183385886|SUPERIORITY|||||||0.265||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.265
91746853|NCT01942668|183385886|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
91502434|NCT01975909|182876130|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.||||||0.18|||||||t-test, 2 sided|||||||0.18
91502435|NCT04350788|182876137|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for patient.||||0.02
91502436|NCT04350788|182876137|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for partner.||||0.25
91502437|NCT04350788|182876138|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in general domain.||||0.36
91502438|NCT04350788|182876138|SUPERIORITY|||||||0.38|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in content domain.||||0.38
91502439|NCT04350788|182876138|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in navigation domain.||||0.02
91746854|NCT01942668|183385886|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
91502440|NCT04350788|182876138|SUPERIORITY|||||||0.62|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in general domain.||||0.62
91502441|NCT04350788|182876138|SUPERIORITY|||||||0.65|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in content domain.||||0.65
91746855|NCT01942668|183385891|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.246|<|0.001|TWO_SIDED|95.0|-2.13|-1.17||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.17|-2.13|<0.001
91746856|NCT01942668|183385891|SUPERIORITY||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.79|-0.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.84|-1.79|<0.001
91746857|NCT01942668|183385891|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.64|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.69|-1.64|<0.001
91746858|NCT01942668|183385891|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.51|-0.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.58|-1.51|<0.001
91502442|NCT04350788|182876138|SUPERIORITY|||||||0.45|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in navigation domain.||||0.45
91502443|NCT04350788|182876139|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
91502444|NCT04350788|182876140|SUPERIORITY|||||||0.01|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in urinary domain.||||0.01
91502445|NCT04350788|182876140|SUPERIORITY|||||||0.41|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in bowel domain.||||0.41
91502446|NCT04350788|182876140|SUPERIORITY|||||||0.21|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in sexual domain.||||0.21
91502447|NCT04350788|182876140|SUPERIORITY|||||||0.52|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in hormonal domain.||||0.52
91502448|NCT04350788|182876140|SUPERIORITY|||||||0.79|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in urinary domain.||||0.79
91502449|NCT04350788|182876140|SUPERIORITY|||||||0.84|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in bowel domain.||||0.84
91502450|NCT04350788|182876140|SUPERIORITY|||||||0.82|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in sexual domain.||||0.82
91502451|NCT04350788|182876140|SUPERIORITY|||||||0.33|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in hormonal domain.||||0.33
91502452|NCT04350788|182876141|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
91502453|NCT04350788|182876141|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
91502454|NCT04350788|182876142|SUPERIORITY|||||||0.05|||||||generalized linear regression|||||||0.05
91502455|NCT04350788|182876143|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
91502456|NCT04350788|182876144|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
91502457|NCT04350788|182876145|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|||||||0.49
91502458|NCT04350788|182876146|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91502459|NCT04350788|182876147|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
91502460|NCT04350788|182876148|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
91746859|NCT01942668|183385892|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.258|<|0.001|TWO_SIDED|95.0|-1.91|-0.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.89|-1.91|<0.001
91746860|NCT01942668|183385892|SUPERIORITY||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.253|<|0.001|TWO_SIDED|95.0|-1.81|-0.82||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.82|-1.81|<0.001
91746861|NCT01942668|183385892|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.257|<|0.001|TWO_SIDED|95.0|-1.63|-0.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.62|-1.63|<0.001
91746862|NCT01942668|183385892|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.254||0.007|TWO_SIDED|95.0|-1.19|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.19|-1.19|0.007
91746863|NCT01942668|183385893|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-1.75|-0.66||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.66|-1.75|<0.001
91746864|NCT01942668|183385893|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.265|<|0.001|TWO_SIDED|95.0|-1.98|-0.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.94|-1.98|<0.001
91746865|NCT01942668|183385893|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.272|<|0.001|TWO_SIDED|95.0|-1.76|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.69|-1.76|<0.001
91746866|NCT01942668|183385893|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.272||0.008|TWO_SIDED|95.0|-1.26|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.19|-1.26|0.008
91746867|NCT01942668|183385894|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.284|TWO_SIDED|95.0|-0.49|0.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.49|0.284
91746868|NCT01942668|183385894|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.732|TWO_SIDED|95.0|-0.36|0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.26|-0.36|0.732
91746869|NCT01942668|183385894|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.159||0.437|TWO_SIDED|95.0|-0.44|0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.44|0.437
91746870|NCT01942668|183385894|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.156||0.439|TWO_SIDED|95.0|-0.43|0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.43|0.439
91746871|NCT01942668|183385895|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.04|TWO_SIDED|95.0|-0.68|-0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.02|-0.68|0.040
91746872|NCT01942668|183385895|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.165||0.066|TWO_SIDED|95.0|-0.63|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.02|-0.63|0.066
91746873|NCT01942668|183385895|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.469|TWO_SIDED|95.0|-0.45|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|-0.45|0.469
91746874|NCT01942668|183385895|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.166||0.616|TWO_SIDED|95.0|-0.41|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.41|0.616
91746875|NCT01942668|183385896|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.183||0.25|TWO_SIDED|95.0|-0.57|0.15||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.57|0.250
91746876|NCT01942668|183385896|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.175||0.002|TWO_SIDED|95.0|-0.88|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.20|-0.88|0.002
91746877|NCT01942668|183385896|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.179||0.796|TWO_SIDED|95.0|-0.4|0.31||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.31|-0.40|0.796
91746878|NCT01942668|183385896|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.179||0.955|TWO_SIDED|95.0|-0.36|0.34||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.34|-0.36|0.955
91746879|NCT01942668|183385897|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.143||0.474|TWO_SIDED|95.0|-0.38|0.18||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.18|-0.38|0.474
91746880|NCT01942668|183385897|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.378|TWO_SIDED|95.0|-0.4|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.15|-0.40|0.378
91746881|NCT01942668|183385897|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.141||0.018|TWO_SIDED|95.0|-0.61|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.61|0.018
91502461|NCT01698463|182876194|OTHER||||||<|0.05||||||\<0.05 (threshold for significance).|Wilcoxon (Mann-Whitney)|||||||<0.05
91502462|NCT04709575|182876195|SUPERIORITY||linear mixed-effect model|-0.995||||0.0497|TWO_SIDED|95.0|-1.9886|-0.0011|||LS Mean Difference|||||-0.0011|-1.9886|0.0497
91746882|NCT01942668|183385897|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.73|TWO_SIDED|95.0|-0.32|0.22||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.22|-0.32|0.730
91746883|NCT01942668|183385898|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.152||0.197|TWO_SIDED|95.0|-0.49|0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.10|-0.49|0.197
91746884|NCT01942668|183385898|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.308|TWO_SIDED|95.0|-0.44|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.44|0.308
91746885|NCT01942668|183385898|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.152||0.117|TWO_SIDED|95.0|-0.54|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.06|-0.54|0.117
91746886|NCT01942668|183385898|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.149||0.739|TWO_SIDED|95.0|-0.34|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.34|0.739
91746887|NCT01942668|183385899|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.635|TWO_SIDED|95.0|-0.42|0.26||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.26|-0.42|0.635
91746888|NCT01942668|183385899|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.164||0.01|TWO_SIDED|95.0|-0.75|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.75|0.010
91746889|NCT01942668|183385899|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.169||0.092|TWO_SIDED|95.0|-0.62|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.62|0.092
91746890|NCT01942668|183385899|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.168||0.243|TWO_SIDED|95.0|-0.53|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.13|-0.53|0.243
91746891|NCT01942668|183385900|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.049|TWO_SIDED|95.0|-0.83|0.0||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.00|-0.83|0.049
91746892|NCT01942668|183385900|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.206||0.773|TWO_SIDED|95.0|-0.34|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.46|-0.34|0.773
91746893|NCT01942668|183385900|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.208||0.081|TWO_SIDED|95.0|-0.77|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.05|-0.77|0.081
91746894|NCT01942668|183385900|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.204||0.625|TWO_SIDED|95.0|-0.5|0.3||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.30|-0.50|0.625
91746895|NCT01942668|183385901|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.221||0.221|TWO_SIDED|95.0|-0.7|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.70|0.221
91746896|NCT01942668|183385901|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.214||0.992|TWO_SIDED|95.0|-0.42|0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.42|-0.42|0.992
91746897|NCT01942668|183385901|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.181|TWO_SIDED|95.0|-0.72|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.72|0.181
91746898|NCT01942668|183385901|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.216||0.846|TWO_SIDED|95.0|-0.47|0.38||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.38|-0.47|0.846
91502463|NCT02967692|182876214|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.042|TWO_SIDED|95.0|0.655|1.027|||Log Rank|||||1.027|0.655|0.042
91502464|NCT02967692|182876222|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.2975|TWO_SIDED|95.0|0.865|1.619|||Log Rank|||||1.619|0.865|0.2975
91502465|NCT04447417|182876241|OTHER||Point estimate|0.43|||<=|0.0001|TWO_SIDED|90.0|0.37|0.49||One-sided p-value. Threshold for significance at 0.05 level.|linear mixed model||Point estimate obtained was back-transformed by exponentiation|TEWL data for linear mixed model was log-transformed to account for right skewness of data and heteroskedasticity. The linear mixed effect on log (TEWL) included age, sex, number of STS, localization on the body, visit, number of STS-by-visit interaction and number of STS-by-age interaction as fixed effects. Model was run on data on lesional skin area.||0.49|0.37|<=0.0001
91746899|NCT01942668|183385902|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.257||0.421|TWO_SIDED|95.0|-0.71|0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.30|-0.71|0.421
91746900|NCT01942668|183385902|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.244||0.044|TWO_SIDED|95.0|-0.97|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.01|-0.97|0.044
91746901|NCT01942668|183385902|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.252||0.093|TWO_SIDED|95.0|-0.92|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.92|0.093
91746902|NCT01942668|183385902|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.252||0.247|TWO_SIDED|95.0|-0.79|0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.79|0.247
91746903|NCT01942668|183385903|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.87|-0.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.29|-0.87|<0.001
91502466|NCT00066066|182876271|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||>0.05
91746904|NCT01942668|183385903|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.143||0.016|TWO_SIDED|95.0|-0.62|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.62|0.016
91746905|NCT01942668|183385903|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|TWO_SIDED|95.0|-0.76|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.76|<0.001
91746906|NCT01942668|183385903|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.141||0.023|TWO_SIDED|95.0|-0.6|-0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.05|-0.60|0.023
91746907|NCT01942668|183385904|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.25|-0.84|<0.001
91746908|NCT01942668|183385904|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.004|TWO_SIDED|95.0|-0.71|-0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.13|-0.71|0.004
91746909|NCT01942668|183385904|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.149||0.003|TWO_SIDED|95.0|-0.73|-0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.14|-0.73|0.003
91746910|NCT01942668|183385904|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.147||0.179|TWO_SIDED|95.0|-0.49|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.09|-0.49|0.179
91746911|NCT01942668|183385905|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.169||0.012|TWO_SIDED|95.0|-0.76|-0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.76|0.012
91746912|NCT01942668|183385905|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|-1.05|-0.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.41|-1.05|<0.001
91746913|NCT01942668|183385905|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.004|TWO_SIDED|95.0|-0.81|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.16|-0.81|0.004
91746914|NCT01942668|183385905|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.166||0.07|TWO_SIDED|95.0|-0.63|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.03|-0.63|0.070
91746915|NCT01942668|183385906|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|2.059||0.033|TWO_SIDED|95.0|-8.44|-0.35||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.35|-8.44|0.033
91746916|NCT01942668|183385906|SUPERIORITY||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|2.015||0.207|TWO_SIDED|95.0|-6.5|1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.50|0.207
91746917|NCT01942668|183385906|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.03||0.024|TWO_SIDED|95.0|-8.58|-0.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.61|-8.58|0.024
91746918|NCT01942668|183385906|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.007||0.207|TWO_SIDED|95.0|-6.47|1.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.47|0.207
91746919|NCT01942668|183385907|SUPERIORITY||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|2.138||0.011|TWO_SIDED|95.0|-9.68|-1.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.28|-9.68|0.011
91746920|NCT01942668|183385907|SUPERIORITY||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|2.093||0.012|TWO_SIDED|95.0|-9.36|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.14|-9.36|0.012
91502467|NCT00066066|182876271|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||>0.05
91746921|NCT01942668|183385907|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|2.122||0.009|TWO_SIDED|95.0|-9.75|-1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.41|-9.75|0.009
91746922|NCT01942668|183385907|SUPERIORITY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|2.096||0.018|TWO_SIDED|95.0|-9.11|-0.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.87|-9.11|0.018
91746923|NCT01942668|183385908|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|2.427||0.058|TWO_SIDED|95.0|-9.38|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.16|-9.38|0.058
91746924|NCT01942668|183385908|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|2.322||0.001|TWO_SIDED|95.0|-12.04|-2.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.92|-12.04|0.001
91746925|NCT01942668|183385908|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|2.397|<|0.001|TWO_SIDED|95.0|-12.67|-3.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.25|-12.67|<0.001
91746926|NCT01942668|183385908|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.404||0.005|TWO_SIDED|95.0|-11.5|-2.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.06|-11.50|0.005
91746927|NCT01942668|183385909|SUPERIORITY||Mean Difference (Final Values)|-6.48|STANDARD_ERROR_OF_MEAN|2.77||0.02|TWO_SIDED|95.0|-11.92|-1.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.04|-11.92|0.020
91746928|NCT01942668|183385909|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.715||0.216|TWO_SIDED|95.0|-8.69|1.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.97|-8.69|0.216
91746929|NCT01942668|183385909|SUPERIORITY||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|2.734||0.033|TWO_SIDED|95.0|-11.22|-0.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.48|-11.22|0.033
91746930|NCT01942668|183385909|SUPERIORITY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|2.685||0.265|TWO_SIDED|95.0|-8.27|2.28||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.28|-8.27|0.265
91746931|NCT01942668|183385910|SUPERIORITY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.854||0.008|TWO_SIDED|95.0|-13.14|-1.93||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.93|-13.14|0.008
91746932|NCT01942668|183385910|SUPERIORITY||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.781||0.016|TWO_SIDED|95.0|-12.18|-1.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.26|-12.18|0.016
91746933|NCT01942668|183385910|SUPERIORITY||Mean Difference (Final Values)|-8.69|STANDARD_ERROR_OF_MEAN|2.847||0.002|TWO_SIDED|95.0|-14.28|-3.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.10|-14.28|0.002
91746934|NCT01942668|183385910|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.8||0.028|TWO_SIDED|95.0|-11.68|-0.68||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.68|-11.68|0.028
91746935|NCT01942668|183385911|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|3.18||0.04|TWO_SIDED|95.0|-12.8|-0.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.31|-12.80|0.040
91746936|NCT01942668|183385911|SUPERIORITY||Mean Difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|-15.99|-4.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.04|-15.99|0.001
91746937|NCT01942668|183385911|SUPERIORITY||Mean Difference (Final Values)|-9.96|STANDARD_ERROR_OF_MEAN|3.129||0.002|TWO_SIDED|95.0|-16.11|-3.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.81|-16.11|0.002
91746938|NCT01942668|183385911|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|3.127||0.029|TWO_SIDED|95.0|-12.99|-0.7||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.70|-12.99|0.029
91746939|NCT01942668|183385912|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|3.003||0.294|TWO_SIDED|95.0|-2.75|9.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.05|-2.75|0.294
91746940|NCT01942668|183385912|SUPERIORITY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.922||0.327|TWO_SIDED|95.0|-2.87|8.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||8.60|-2.87|0.327
91746941|NCT01942668|183385912|SUPERIORITY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.947||0.637|TWO_SIDED|95.0|-7.18|4.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.39|-7.18|0.637
91746942|NCT01942668|183385912|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|2.893||0.952|TWO_SIDED|95.0|-5.51|5.86||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||5.86|-5.51|0.952
91746943|NCT01942668|183385913|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|3.219||0.573|TWO_SIDED|95.0|-4.51|8.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||8.14|-4.51|0.573
91746944|NCT01942668|183385913|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|3.107||0.769|TWO_SIDED|95.0|-7.01|5.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.19|-7.01|0.769
91746945|NCT01942668|183385913|SUPERIORITY||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|3.176||0.047|TWO_SIDED|95.0|-12.56|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.09|-12.56|0.047
91746946|NCT01942668|183385913|SUPERIORITY||Mean Difference (Final Values)|-2.59|STANDARD_ERROR_OF_MEAN|3.133||0.409|TWO_SIDED|95.0|-8.74|3.56||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.56|-8.74|0.409
91746947|NCT01942668|183385914|SUPERIORITY||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.443||0.579|TWO_SIDED|95.0|-4.85|8.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.67|-4.85|0.579
91746948|NCT01942668|183385914|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|3.275||0.223|TWO_SIDED|95.0|-10.43|2.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.44|-10.43|0.223
91746949|NCT01942668|183385914|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|3.367||0.542|TWO_SIDED|95.0|-8.67|4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.56|-8.67|0.542
91746950|NCT01942668|183385914|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|3.376||0.476|TWO_SIDED|95.0|-9.04|4.23||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.23|-9.04|0.476
91746951|NCT01942668|183385915|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|2.593||0.631|TWO_SIDED|95.0|-6.34|3.84||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.84|-6.34|0.631
91746952|NCT01942668|183385915|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|2.54||0.651|TWO_SIDED|95.0|-3.84|6.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||6.14|-3.84|0.651
91746953|NCT01942668|183385915|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|2.578||0.813|TWO_SIDED|95.0|-5.67|4.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.45|-5.67|0.813
91746954|NCT01942668|183385915|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.515||0.869|TWO_SIDED|95.0|-5.35|4.52||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.52|-5.35|0.869
91746955|NCT01942668|183385916|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|2.79||0.074|TWO_SIDED|95.0|-10.48|0.48||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.48|-10.48|0.074
91746956|NCT01942668|183385916|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.722||0.748|TWO_SIDED|95.0|-6.22|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||4.47|-6.22|0.748
91746957|NCT01942668|183385916|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.805||0.987|TWO_SIDED|95.0|-5.46|5.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||5.56|-5.46|0.987
91746958|NCT01942668|183385916|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|2.741||0.709|TWO_SIDED|95.0|-6.41|4.36||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.36|-6.41|0.709
91746959|NCT01942668|183385917|SUPERIORITY||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|2.968||0.379|TWO_SIDED|95.0|-8.44|3.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.22|-8.44|0.379
91746960|NCT01942668|183385917|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_ERROR_OF_MEAN|2.832||0.279|TWO_SIDED|95.0|-8.64|2.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.49|-8.64|0.279
91746961|NCT01942668|183385917|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.949||0.894|TWO_SIDED|95.0|-6.19|5.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.40|-6.19|0.894
91746962|NCT01942668|183385917|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.923||0.308|TWO_SIDED|95.0|-8.72|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.76|-8.72|0.308
91746963|NCT01942668|183385918|SUPERIORITY||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|3.081||0.558|TWO_SIDED|95.0|-4.24|7.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.86|-4.24|0.558
91746964|NCT01942668|183385918|SUPERIORITY||Mean Difference (Final Values)|3.61|STANDARD_ERROR_OF_MEAN|3.031||0.233|TWO_SIDED|95.0|-2.34|9.57||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.57|-2.34|0.233
91746965|NCT01942668|183385918|SUPERIORITY||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|3.036||0.043|TWO_SIDED|95.0|0.2|12.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||12.13|0.20|0.043
91746966|NCT01942668|183385918|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|2.99||0.488|TWO_SIDED|95.0|-3.8|7.95||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||7.95|-3.80|0.488
91746967|NCT01942668|183385919|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|3.206||0.205|TWO_SIDED|95.0|-2.23|10.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.37|-2.23|0.205
91746968|NCT01942668|183385919|SUPERIORITY||Mean Difference (Final Values)|9.58|STANDARD_ERROR_OF_MEAN|3.133||0.002|TWO_SIDED|95.0|3.43|15.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||15.74|3.43|0.002
91746969|NCT01942668|183385919|SUPERIORITY||Mean Difference (Final Values)|5.04|STANDARD_ERROR_OF_MEAN|3.193||0.115|TWO_SIDED|95.0|-1.23|11.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.32|-1.23|0.115
91502468|NCT00066066|182876271|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||<0.05
91502469|NCT00066066|182876271|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||<0.05
91531634|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.007|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.007
91531635|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.046|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.046
91502470|NCT00066066|182876271|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||<0.05
91502471|NCT00066066|182876271|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||>0.05
91502472|NCT02155738|182876272|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.||||<0.05
91502473|NCT02155738|182876273|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.||||<0.05
91502474|NCT01466348|182876275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.6||||0.0008|TWO_SIDED|95.0|1.5|5.6|||ANOVA|No baseline covariate adjustment was carried out.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.6|1.5|0.0008
91502475|NCT01466348|182876276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|4.5|8.4|||ANOVA|No baseline covariate adjustment was applied.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||8.4|4.5|<0.0001
91502476|NCT03928847|182876298|SUPERIORITY|The mean EGCG blood levels were compared among 450 mg, 600 mg, and 750 mg groups.|Mean Difference (Net)|250.0|||||TWO_SIDED|||||||||||||
91502477|NCT03928847|182876299|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91502478|NCT03928847|182876300|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91502479|NCT03928847|182876301|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
91502480|NCT03928847|182876302|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
91502481|NCT03928847|182876303|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
91502482|NCT00914810|182876305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5|||t-test, 2 sided|||||1.5|-0.8|0.55
91502483|NCT00914810|182876306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.4|13.6|||t-test, 2 sided|||||13.6|7.4|<0.0001
91502484|NCT01268111|182876317|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.4
91502485|NCT00952341|182876321|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.007
91502486|NCT00952341|182876322|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.942
91502487|NCT00952341|182876323|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.001
91502488|NCT00952341|182876324|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy."||||0.003
91502489|NCT00952341|182876325|SUPERIORITY_OR_OTHER|||||||0.882||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.882
91502490|NCT00952341|182876326|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.001
91502491|NCT02066467|182876349|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
91502492|NCT02066467|182876351|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
91502493|NCT04259762|182876352|OTHER|This is a summary of the total number of participants in the focus groups who endorsed the particular theme.|Proportion endorsing themes|1.0|||||TWO_SIDED|||||||||All focus groups were summarized together and, therefore, the denominators (N=85 \[Community\], N=11 \[Provider\]) for each theme are the same. Further, the focus groups only made qualitative (and no quantitative) assessments/endoresement of themes. No formal comparisons among groups were made.||||
91502494|NCT04259762|182876354|OTHER|Formal statistical comparisons were not made.|Proportion endorsing attempt to screen|0.567|||||TWO_SIDED|95.0|0.303|0.831|||||"Pooled estimate of attempt to screening. Using R:~n1 \<- c(20,28,11,15,26,23,21); nt \<- c(45,50,45,50,50,50,22) p1 \<- n1/nt; v1 \<- p1\*(1-p1)/nt fit \<- lm(p1 \~ 1,weight=1/v1) summary(fit)$coef\[1\] + qt(.975,6)\*c(0,-1,1)\*summary(fit)$coef\[2\]"|||0.831|0.303|
91502495|NCT03453684|182876355|OTHER||Overall SE of the estimate|0.009|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.45 Standard error of the estimate of w\^2: 0.39|||||
91502496|NCT03453684|182876356|OTHER||Overall Standard Error of the Estimate|9.85|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.61 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
91502497|NCT03453684|182876357|OTHER||Overall Standard Error of the Estimate|8.37|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
91502498|NCT03453684|182876358|OTHER||Overall Standard Error of the Estimate|4.83|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.003 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.03|||||
91502499|NCT03453684|182876359|OTHER||Overall Standard Error of the Estimate|17.21|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.13|||||
91502500|NCT03453684|182876360|OTHER||SE of the estimate of Typical Value|0.2|||||TWO_SIDED|||||||||||||
91502501|NCT03453684|182876361|OTHER||SE of the estimate of Typical Value|2.1|||||TWO_SIDED||||||||Standard error of the estimate of Typical value should be read as: 2.1E-06 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.24|||||
91502502|NCT03453684|182876362|OTHER||SE of the estimate of Typical Value|2.3|||||TWO_SIDED||||||||Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.08|||||
91502503|NCT03453684|182876363|OTHER||Overall Standard Error of the Estimate|10.8|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02|||||
91746970|NCT01942668|183385919|SUPERIORITY||Mean Difference (Final Values)|8.94|STANDARD_ERROR_OF_MEAN|3.152||0.005|TWO_SIDED|95.0|2.75|15.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||15.13|2.75|0.005
91746971|NCT01942668|183385920|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|3.719||0.796|TWO_SIDED|95.0|-6.34|8.27||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.27|-6.34|0.796
91746972|NCT01942668|183385920|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|3.568||0.15|TWO_SIDED|95.0|-1.87|12.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||12.15|-1.87|0.150
91746973|NCT01942668|183385920|SUPERIORITY||Mean Difference (Final Values)|8.58|STANDARD_ERROR_OF_MEAN|3.657||0.019|TWO_SIDED|95.0|1.39|15.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||15.77|1.39|0.019
91746974|NCT01942668|183385920|SUPERIORITY||Mean Difference (Final Values)|7.51|STANDARD_ERROR_OF_MEAN|3.667||0.041|TWO_SIDED|95.0|0.3|14.71||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||14.71|0.30|0.041
91746975|NCT01942668|183385921|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.197||0.221|TWO_SIDED|95.0|-7.0|1.62||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.62|-7.00|0.221
91746976|NCT01942668|183385921|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|2.154||0.511|TWO_SIDED|95.0|-5.65|2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.81|-5.65|0.511
91746977|NCT01942668|183385921|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|2.168||0.761|TWO_SIDED|95.0|-3.6|4.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.92|-3.60|0.761
91746978|NCT01942668|183385921|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.128||0.332|TWO_SIDED|95.0|-6.25|2.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.11|-6.25|0.332
91746979|NCT01942668|183385922|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.474||0.687|TWO_SIDED|95.0|-5.86|3.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.86|-5.86|0.687
91746980|NCT01942668|183385922|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|2.411||0.373|TWO_SIDED|95.0|-6.88|2.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.58|-6.88|0.373
91746981|NCT01942668|183385922|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|2.466||0.714|TWO_SIDED|95.0|-5.75|3.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.94|-5.75|0.714
91746982|NCT01942668|183385922|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.427||0.711|TWO_SIDED|95.0|-5.67|3.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.87|-5.67|0.711
91746983|NCT01942668|183385923|SUPERIORITY||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.682||0.415|TWO_SIDED|95.0|-7.46|3.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.08|-7.46|0.415
91746984|NCT01942668|183385923|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|2.564||0.019|TWO_SIDED|95.0|-11.04|-0.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.97|-11.04|0.019
91746985|NCT01942668|183385923|SUPERIORITY||Mean Difference (Final Values)|-4.72|STANDARD_ERROR_OF_MEAN|2.639||0.074|TWO_SIDED|95.0|-9.9|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.46|-9.90|0.074
91746986|NCT01942668|183385923|SUPERIORITY||Mean Difference (Final Values)|-5.75|STANDARD_ERROR_OF_MEAN|2.637||0.03|TWO_SIDED|95.0|-10.94|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.57|-10.94|0.030
91502504|NCT03453684|182876364|OTHER||SE of the estimate of Typical Value|0.9|||||TWO_SIDED|||||||||||||
91502505|NCT00706979|182876365|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.008|TWO_SIDED|95.0|1.1|1.4|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.||1.4|1.1|0.008
91502506|NCT00706979|182876366|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|1.0|1.7|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.||1.7|1.0|0.09
91746987|NCT01942668|183385924|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.109||0.059|TWO_SIDED|95.0|-8.13|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-8.13|0.059
91746988|NCT01942668|183385924|SUPERIORITY||Mean Difference (Final Values)|-2.57|STANDARD_ERROR_OF_MEAN|2.067||0.215|TWO_SIDED|95.0|-6.63|1.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.49|-6.63|0.215
91746989|NCT01942668|183385924|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|2.084||0.015|TWO_SIDED|95.0|-9.19|-1.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.00|-9.19|0.015
91746990|NCT01942668|183385924|SUPERIORITY||Mean Difference (Final Values)|-3.16|STANDARD_ERROR_OF_MEAN|2.042||0.122|TWO_SIDED|95.0|-7.17|0.85||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.85|-7.17|0.122
91746991|NCT01942668|183385925|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.135||0.013|TWO_SIDED|95.0|-9.52|-1.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.13|-9.52|0.013
91746992|NCT01942668|183385925|SUPERIORITY||Mean Difference (Final Values)|-5.76|STANDARD_ERROR_OF_MEAN|2.08||0.006|TWO_SIDED|95.0|-9.85|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.68|-9.85|0.006
91746993|NCT01942668|183385925|SUPERIORITY||Mean Difference (Final Values)|-5.59|STANDARD_ERROR_OF_MEAN|2.132||0.009|TWO_SIDED|95.0|-9.77|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.40|-9.77|0.009
91746994|NCT01942668|183385925|SUPERIORITY||Mean Difference (Final Values)|-5.68|STANDARD_ERROR_OF_MEAN|2.093||0.007|TWO_SIDED|95.0|-9.79|-1.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.57|-9.79|0.007
91746995|NCT01942668|183385926|SUPERIORITY||Mean Difference (Final Values)|-3.39|STANDARD_ERROR_OF_MEAN|2.47||0.171|TWO_SIDED|95.0|-8.24|1.47||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.47|-8.24|0.171
91746996|NCT01942668|183385926|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|2.364||0.006|TWO_SIDED|95.0|-11.14|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.85|-11.14|0.006
91746997|NCT01942668|183385926|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_ERROR_OF_MEAN|2.434||0.003|TWO_SIDED|95.0|-12.17|-2.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.61|-12.17|0.003
91746998|NCT01942668|183385926|SUPERIORITY||Mean Difference (Final Values)|-6.69|STANDARD_ERROR_OF_MEAN|2.429||0.006|TWO_SIDED|95.0|-11.46|-1.92||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.92|-11.46|0.006
91746999|NCT01942668|183385927|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.037||0.039|TWO_SIDED|95.0|-8.21|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.21|-8.21|0.039
91747000|NCT01942668|183385927|SUPERIORITY||Mean Difference (Final Values)|-2.39|STANDARD_ERROR_OF_MEAN|1.997||0.232|TWO_SIDED|95.0|-6.31|1.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.53|-6.31|0.232
91747001|NCT01942668|183385927|SUPERIORITY||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.012||0.03|TWO_SIDED|95.0|-8.32|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-8.32|0.030
91747002|NCT01942668|183385927|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|1.973||0.262|TWO_SIDED|95.0|-6.09|1.66||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.66|-6.09|0.262
91747003|NCT01942668|183385928|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|2.119||0.011|TWO_SIDED|95.0|-9.57|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.25|-9.57|0.011
91747004|NCT01942668|183385928|SUPERIORITY||Mean Difference (Final Values)|-5.54|STANDARD_ERROR_OF_MEAN|2.065||0.008|TWO_SIDED|95.0|-9.6|-1.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.48|-9.60|0.008
91747005|NCT01942668|183385928|SUPERIORITY||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|2.115||0.007|TWO_SIDED|95.0|-9.9|-1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.59|-9.90|0.007
91747006|NCT01942668|183385928|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.078||0.011|TWO_SIDED|95.0|-9.4|-1.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.24|-9.40|0.011
91747007|NCT01942668|183385929|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.421||0.083|TWO_SIDED|95.0|-8.96|0.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.55|-8.96|0.083
91747008|NCT01942668|183385929|SUPERIORITY||Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|2.317||0.002|TWO_SIDED|95.0|-11.91|-2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.81|-11.91|0.002
91747009|NCT01942668|183385929|SUPERIORITY||Mean Difference (Final Values)|-7.92|STANDARD_ERROR_OF_MEAN|2.384|<|0.001|TWO_SIDED|95.0|-12.6|-3.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.23|-12.60|<0.001
91747010|NCT01942668|183385929|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.381||0.005|TWO_SIDED|95.0|-11.46|-2.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.10|-11.46|0.005
91747011|NCT01942668|183385930|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.938|TWO_SIDED|95.0|-0.12|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.12|0.938
91502507|NCT00706979|182876367|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.004|TWO_SIDED|95.0|1.1|1.5|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.||1.5|1.1|0.004
91502508|NCT00706979|182876368|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.6|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.||1.6|0.9|0.3
91502509|NCT02418468|182876397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.262|TWO_SIDED|95.0|-0.26|0.07|||mixed models for repeated measures (MMRM|||||0.07|-0.26|0.262
91531636|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.002
91502510|NCT02337907|182876404|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.073||0.7907|TWO_SIDED|95.0|-0.163|0.124||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.124|-0.163|0.7907
91502511|NCT02337907|182876404|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7622|TWO_SIDED|95.0|-0.125|0.171||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.171|-0.125|0.7622
91531637|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.4||0.44|TWO_SIDED|95.0|-4.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-4.0|0.44
91531638|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-5.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-5.0|0.21
91747012|NCT01942668|183385930|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.779|TWO_SIDED|95.0|-0.1|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.13|-0.10|0.779
91747013|NCT01942668|183385930|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.059||0.646|TWO_SIDED|95.0|-0.14|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.14|0.646
91747014|NCT01942668|183385930|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.058||0.421|TWO_SIDED|95.0|-0.07|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.07|0.421
91747015|NCT01942668|183385931|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.063||0.075|TWO_SIDED|95.0|-0.01|0.24||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.01|0.075
91747016|NCT01942668|183385931|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.062||0.074|TWO_SIDED|95.0|-0.01|0.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.23|-0.01|0.074
91747017|NCT01942668|183385931|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063||0.37|TWO_SIDED|95.0|-0.07|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.07|0.370
91747018|NCT01942668|183385931|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.062||0.851|TWO_SIDED|95.0|-0.11|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.13|-0.11|0.851
91747019|NCT01942668|183385932|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.067||0.452|TWO_SIDED|95.0|-0.18|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.18|0.452
91747020|NCT01942668|183385932|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.064||0.244|TWO_SIDED|95.0|-0.05|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.05|0.244
91747021|NCT01942668|183385932|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.065||0.354|TWO_SIDED|95.0|-0.19|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.19|0.354
91747022|NCT01942668|183385932|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.065||0.527|TWO_SIDED|95.0|-0.17|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.09|-0.17|0.527
91747023|NCT01942668|183385933|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-2.29|-1.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.55|-2.29|<0.001
91747024|NCT01942668|183385933|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
91747025|NCT01942668|183385933|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
91747026|NCT01942668|183385933|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.188|<|0.001|TWO_SIDED|95.0|-1.62|-0.88||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.88|-1.62|<0.001
91502512|NCT02337907|182876404|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.071||0.8789|TWO_SIDED|95.0|-0.13|0.152||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.152|-0.130|0.8789
91502513|NCT02337907|182876404|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0609|TWO_SIDED|95.0|-0.285|0.006||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.006|-0.285|0.0609
91531639|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
91502514|NCT02337907|182876404|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5687|TWO_SIDED|95.0|-0.135|0.074||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.074|-0.135|0.5687
91502515|NCT02337907|182876405|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.120|-0.101|0.8694
91502516|NCT02337907|182876405|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.109|-0.116|0.9512
91502517|NCT02337907|182876405|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.115|-0.105|0.9321
91502518|NCT02337907|182876405|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.025|-0.199|0.1288
91502519|NCT02337907|182876405|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.061|-0.098|0.6492
91747027|NCT01942668|183385934|SUPERIORITY||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.199|<|0.001|TWO_SIDED|95.0|-2.12|-1.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.34|-2.12|<0.001
91747028|NCT01942668|183385934|SUPERIORITY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.68|-0.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.91|-1.68|<0.001
91747029|NCT01942668|183385934|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.58|-0.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.81|-1.58|<0.001
91747030|NCT01942668|183385934|SUPERIORITY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.198|<|0.001|TWO_SIDED|95.0|-1.34|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.57|-1.34|<0.001
91747031|NCT01942668|183385935|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-2.06|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.25|-2.06|<0.001
91747032|NCT01942668|183385935|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.87|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.07|-1.87|<0.001
91747033|NCT01942668|183385935|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.205|<|0.001|TWO_SIDED|95.0|-1.7|-0.9||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.90|-1.70|<0.001
91502520|NCT02337907|182876406|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|1.066||0.5287|TWO_SIDED|95.0|-1.43|2.77||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||2.77|-1.43|0.5287
91502521|NCT02337907|182876406|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.099||0.7105|TWO_SIDED|95.0|-2.57|1.76||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.76|-2.57|0.7105
91502522|NCT02337907|182876406|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.064||0.3822|TWO_SIDED|95.0|-1.16|3.03||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.03|-1.16|0.3822
91502523|NCT02337907|182876406|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.066||0.6472|TWO_SIDED|95.0|-2.59|1.61||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.61|-2.59|0.6472
91502524|NCT02337907|182876407|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7551|TWO_SIDED|95.0|-0.46|0.64||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.64|-0.46|0.7551
91502525|NCT02337907|182876407|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3643|TWO_SIDED|95.0|-0.29|0.8||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.80|-0.29|0.3643
91502526|NCT02337907|182876407|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7822|TWO_SIDED|95.0|-0.45|0.6||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.60|-0.45|0.7822
91747034|NCT01942668|183385935|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-1.48|-0.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.67|-1.48|<0.001
91502527|NCT02337907|182876407|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.6889|TWO_SIDED|95.0|-0.43|0.65||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.65|-0.43|0.6889
91747035|NCT01942668|183385936|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.126|TWO_SIDED|95.0|-0.46|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.46|0.126
91747036|NCT01942668|183385936|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.2|TWO_SIDED|95.0|-0.42|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.42|0.200
91502528|NCT02337907|182876408|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.933||0.1595|TWO_SIDED|95.0|-0.52|3.15||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.15|-0.52|0.1595
91747037|NCT01942668|183385936|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.222|TWO_SIDED|95.0|-0.41|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.10|-0.41|0.222
91502529|NCT02337907|182876408|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.962||0.2455|TWO_SIDED|95.0|-0.77|3.01||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.01|-0.77|0.2455
91502530|NCT02337907|182876408|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.94||0.1732|TWO_SIDED|95.0|-0.57|3.13||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.13|-0.57|0.1732
91531640|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.029|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.029
91531641|NCT02886728|182939610|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.010
91747038|NCT01942668|183385936|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.358|TWO_SIDED|95.0|-0.37|0.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.37|0.358
91747039|NCT01942668|183385937|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.138||0.023|TWO_SIDED|95.0|-0.59|-0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.04|-0.59|0.023
91747040|NCT01942668|183385937|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.138||0.045|TWO_SIDED|95.0|-0.55|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.01|-0.55|0.045
91747041|NCT01942668|183385937|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.137||0.384|TWO_SIDED|95.0|-0.39|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.39|0.384
91747042|NCT01942668|183385937|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.424|TWO_SIDED|95.0|-0.38|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.38|0.424
91747043|NCT01942668|183385938|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.152||0.153|TWO_SIDED|95.0|-0.52|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.52|0.153
91747044|NCT01942668|183385938|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.151||0.058|TWO_SIDED|95.0|-0.58|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.58|0.058
91747045|NCT01942668|183385938|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.151||0.55|TWO_SIDED|95.0|-0.39|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.21|-0.39|0.550
91747046|NCT01942668|183385938|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.153||0.854|TWO_SIDED|95.0|-0.33|0.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.27|-0.33|0.854
91747047|NCT01942668|183385939|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.116||0.181|TWO_SIDED|95.0|-0.38|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.07|-0.38|0.181
91747048|NCT01942668|183385939|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.116||0.108|TWO_SIDED|95.0|-0.41|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.04|-0.41|0.108
91747049|NCT01942668|183385939|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.115||0.014|TWO_SIDED|95.0|-0.51|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.51|0.014
91747050|NCT01942668|183385939|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.323|TWO_SIDED|95.0|-0.34|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.34|0.323
91747051|NCT01942668|183385940|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.124||0.056|TWO_SIDED|95.0|-0.48|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.01|-0.48|0.056
91747052|NCT01942668|183385940|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.124||0.279|TWO_SIDED|95.0|-0.38|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.38|0.279
91747053|NCT01942668|183385940|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.123||0.435|TWO_SIDED|95.0|-0.34|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.34|0.435
91747054|NCT01942668|183385940|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.124||0.607|TWO_SIDED|95.0|-0.31|0.18||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.31|0.607
91747055|NCT01942668|183385941|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.138||0.06|TWO_SIDED|95.0|-0.53|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.53|0.060
91747056|NCT01942668|183385941|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.137||0.026|TWO_SIDED|95.0|-0.57|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.04|-0.57|0.026
91747057|NCT01942668|183385941|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.136||0.097|TWO_SIDED|95.0|-0.49|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.04|-0.49|0.097
91747058|NCT01942668|183385941|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.138||0.23|TWO_SIDED|95.0|-0.44|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-0.44|0.230
91747059|NCT01942668|183385942|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.107|TWO_SIDED|95.0|-0.61|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.61|0.107
91747060|NCT01942668|183385942|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.169||0.302|TWO_SIDED|95.0|-0.51|0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.51|0.302
91747061|NCT01942668|183385942|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.169||0.106|TWO_SIDED|95.0|-0.6|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.60|0.106
91747062|NCT01942668|183385942|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.169||0.156|TWO_SIDED|95.0|-0.57|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.57|0.156
91747063|NCT01942668|183385943|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.177||0.081|TWO_SIDED|95.0|-0.65|0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.04|-0.65|0.081
91502531|NCT02337907|182876408|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|0.936||0.0088|TWO_SIDED|95.0|0.63|4.31||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||4.31|0.63|0.0088
91502532|NCT01592344|182876409|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0048
91502533|NCT01592344|182876410|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91502534|NCT01592344|182876411|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91502535|NCT01592344|182876412|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91747064|NCT01942668|183385943|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.175||0.212|TWO_SIDED|95.0|-0.56|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.12|-0.56|0.212
91747065|NCT01942668|183385943|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.175||0.345|TWO_SIDED|95.0|-0.51|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.51|0.345
91747066|NCT01942668|183385943|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.176||0.829|TWO_SIDED|95.0|-0.38|0.31||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.31|-0.38|0.829
91747067|NCT01942668|183385944|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.201||0.029|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.029
91747068|NCT01942668|183385944|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.199||0.026|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.026
91747069|NCT01942668|183385944|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.199||0.093|TWO_SIDED|95.0|-0.72|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.06|-0.72|0.093
91747070|NCT01942668|183385944|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.202||0.223|TWO_SIDED|95.0|-0.64|0.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.64|0.223
91747071|NCT01942668|183385945|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.4||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.40|-0.85|<0.001
91747072|NCT01942668|183385945|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.71|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-0.71|<0.001
91747073|NCT01942668|183385945|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.75|-0.3||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.30|-0.75|<0.001
91747074|NCT01942668|183385945|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.64|-0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.64|<0.001
91747075|NCT01942668|183385946|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.38|-0.85|<0.001
91747076|NCT01942668|183385946|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.22|-0.69|<0.001
91747077|NCT01942668|183385946|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.59|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.12|-0.59|0.003
91747078|NCT01942668|183385946|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.03|TWO_SIDED|95.0|-0.5|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.03|-0.50|0.030
91747079|NCT01942668|183385947|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.89|-0.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.89|<0.001
91747080|NCT01942668|183385947|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.88|-0.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.88|<0.001
91747081|NCT01942668|183385947|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.73|-0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.21|-0.73|<0.001
91747082|NCT01942668|183385947|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.006|TWO_SIDED|95.0|-0.63|-0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.63|0.006
91747083|NCT01942668|183385948|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.629||0.003|TWO_SIDED|95.0|-8.08|-1.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.69|-8.08|0.003
91747084|NCT01942668|183385948|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|1.626||0.027|TWO_SIDED|95.0|-6.8|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-6.80|0.027
91747085|NCT01942668|183385948|SUPERIORITY||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.618||0.034|TWO_SIDED|95.0|-6.61|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-6.61|0.034
91747086|NCT01942668|183385948|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|1.621||0.119|TWO_SIDED|95.0|-5.71|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.71|0.119
91747087|NCT01942668|183385949|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.7||0.002|TWO_SIDED|95.0|-8.73|-2.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.05|-8.73|0.002
91747088|NCT01942668|183385949|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.696||0.002|TWO_SIDED|95.0|-8.72|-2.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.06|-8.72|0.002
91747089|NCT01942668|183385949|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.685||0.004|TWO_SIDED|95.0|-8.19|-1.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.58|-8.19|0.004
91747090|NCT01942668|183385949|SUPERIORITY||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|1.698||0.009|TWO_SIDED|95.0|-7.75|-1.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.09|-7.75|0.009
91747091|NCT01942668|183385950|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.855|<|0.001|TWO_SIDED|95.0|-10.18|-2.9||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.90|-10.18|<0.001
91747092|NCT01942668|183385950|SUPERIORITY||Mean Difference (Final Values)|-7.61|STANDARD_ERROR_OF_MEAN|1.843|<|0.001|TWO_SIDED|95.0|-11.23|-4.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.00|-11.23|<0.001
91747093|NCT01942668|183385950|SUPERIORITY||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.04|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.04|<0.001
91747094|NCT01942668|183385950|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.41|-3.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.10|-10.41|<0.001
91502536|NCT02738333|182876421|NON_INFERIORITY|A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.3|7.1|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||7.1|-5.3|
91747095|NCT01942668|183385951|SUPERIORITY||Mean Difference (Final Values)|-7.34|STANDARD_ERROR_OF_MEAN|2.146|<|0.001|TWO_SIDED|95.0|-11.55|-3.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-3.13|-11.55|<0.001
91502537|NCT03033511|182876468|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.537|TWO_SIDED|95.0|0.84|1.36||stratified log-rank test|Log Rank|||||1.36|0.84|0.537
91747096|NCT01942668|183385951|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.139||0.009|TWO_SIDED|95.0|-9.8|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.40|-9.80|0.009
91747097|NCT01942668|183385951|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|2.132||0.016|TWO_SIDED|95.0|-9.31|-0.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.95|-9.31|0.016
91747098|NCT01942668|183385951|SUPERIORITY||Mean Difference (Final Values)|-3.04|STANDARD_ERROR_OF_MEAN|2.13||0.154|TWO_SIDED|95.0|-7.22|1.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.14|-7.22|0.154
91747099|NCT01942668|183385952|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|2.213|<|0.001|TWO_SIDED|95.0|-12.72|-4.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-4.04|-12.72|<0.001
91747100|NCT01942668|183385952|SUPERIORITY||Mean Difference (Final Values)|-7.52|STANDARD_ERROR_OF_MEAN|2.201|<|0.001|TWO_SIDED|95.0|-11.83|-3.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.20|-11.83|<0.001
91747101|NCT01942668|183385952|SUPERIORITY||Mean Difference (Final Values)|-7.32|STANDARD_ERROR_OF_MEAN|2.193|<|0.001|TWO_SIDED|95.0|-11.63|-3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.02|-11.63|<0.001
91747102|NCT01942668|183385952|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.207||0.011|TWO_SIDED|95.0|-9.93|-1.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.27|-9.93|0.011
91747103|NCT01942668|183385953|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.439|<|0.001|TWO_SIDED|95.0|-13.76|-4.19||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.19|-13.76|<0.001
91747104|NCT01942668|183385953|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-14.34|-4.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.85|-14.34|<0.001
91747105|NCT01942668|183385953|SUPERIORITY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|2.412|<|0.001|TWO_SIDED|95.0|-14.03|-4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.56|-14.03|<0.001
91747106|NCT01942668|183385953|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.442||0.002|TWO_SIDED|95.0|-12.51|-2.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.93|-12.51|0.002
91747107|NCT01942668|183385954|SUPERIORITY||Mean Difference (Final Values)|2.02|STANDARD_ERROR_OF_MEAN|2.576||0.434|TWO_SIDED|95.0|-3.03|7.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.07|-3.03|0.434
91747108|NCT01942668|183385954|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.564||0.442|TWO_SIDED|95.0|-3.06|7.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.00|-3.06|0.442
91747109|NCT01942668|183385954|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|2.558||0.558|TWO_SIDED|95.0|-3.52|6.51||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.51|-3.52|0.558
91747110|NCT01942668|183385954|SUPERIORITY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.555||0.534|TWO_SIDED|95.0|-3.42|6.6||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.60|-3.42|0.534
91502538|NCT03033511|182876469|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.237|TWO_SIDED|95.0|0.92|1.36||stratified log-rank test|Log Rank|||||1.36|0.92|0.237
91502539|NCT03033511|182876470|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-3.08|2.35||||||Change at Week 6||2.35|-3.08|
91502540|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|-10.43|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-14.58|-6.29||||||Change at Week 12||-6.29|-14.58|
91502541|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|-27.67|STANDARD_ERROR_OF_MEAN|10.57|||TWO_SIDED|95.0|-46.19|-9.16||||||Change at Week 18||-9.16|-46.19|
91502542|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|-18.44|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-38.28|1.39||||||Change at Week 24||1.39|-38.28|
91502543|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|-22.0|STANDARD_ERROR_OF_MEAN|11.27|||TWO_SIDED|95.0|-42.63|-1.37||||||Change at Week 30||-1.37|-42.63|
91502544|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 36||||
91502545|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|3.33|||||TWO_SIDED|||||||||Change at Week 42||||
91531642|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
91531643|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
91747111|NCT01942668|183385955|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|2.719||0.927|TWO_SIDED|95.0|-5.08|5.58||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.58|-5.08|0.927
91747112|NCT01942668|183385955|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.699||0.541|TWO_SIDED|95.0|-6.95|3.64||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-6.95|0.541
91747113|NCT01942668|183385955|SUPERIORITY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.691||0.171|TWO_SIDED|95.0|-8.96|1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||1.60|-8.96|0.171
91747114|NCT01942668|183385955|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.708||0.667|TWO_SIDED|95.0|-6.48|4.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.15|-6.48|0.667
91747115|NCT01942668|183385956|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.863||0.662|TWO_SIDED|95.0|-4.36|6.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||6.87|-4.36|0.662
91502546|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|-56.67|||||TWO_SIDED|||||||||Change at Week 48||||
91502547|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 60||||
91502548|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 66||||
91502549|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 78||||
91502550|NCT03033511|182876470|SUPERIORITY||LS Mean of Difference|-9.17|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-12.16|-6.19||||||Change at Final Visit||-6.19|-12.16|
91502551|NCT04327388|182876483|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9561|TWO_SIDED|95.0|0.751|1.402|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.402|0.751|0.9561
91502552|NCT04327388|182876483|SUPERIORITY||Hazard Ratio (HR)|1.135||||0.3376|TWO_SIDED|95.0|0.835|1.543|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.543|0.835|0.3376
91502553|NCT04327388|182876484|SUPERIORITY||Difference in percentage|-1.7||||0.628|TWO_SIDED|95.0|-9.27|5.81|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||5.81|-9.27|0.6280
91502554|NCT04327388|182876484|SUPERIORITY||Difference in percentage|0.2||||0.8478|TWO_SIDED|95.0|-6.93|7.41|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||7.41|-6.93|0.8478
91502555|NCT01464346|182876718|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|88.01|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED|95.0|85.69|90.33|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||90.33|85.69|<0.05
91502556|NCT01464346|182876719|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|90.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|88.77|92.28|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||92.28|88.77|< 0.05
91502557|NCT01286012|182876732|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91502558|NCT01286012|182876733|SUPERIORITY_OR_OTHER|||||||0.915|||||||Cochran-Mantel-Haenszel|||||||0.915
91502559|NCT01286012|182876734|SUPERIORITY_OR_OTHER|||||||0.6714|||||||Cochran-Mantel-Haenszel|||||||0.6714
91502560|NCT01286012|182876735|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91502561|NCT01286012|182876736|SUPERIORITY_OR_OTHER|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
91747116|NCT01942668|183385956|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|2.834||0.635|TWO_SIDED|95.0|-6.91|4.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||4.21|-6.91|0.635
91747117|NCT01942668|183385956|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.827||0.877|TWO_SIDED|95.0|-5.98|5.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.11|-5.98|0.877
91747118|NCT01942668|183385956|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.867||0.893|TWO_SIDED|95.0|-6.01|5.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.24|-6.01|0.893
91747119|NCT01942668|183385957|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.058||0.83|TWO_SIDED|95.0|-4.48|3.59||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.59|-4.48|0.830
91747120|NCT01942668|183385957|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|2.05||0.755|TWO_SIDED|95.0|-4.66|3.38||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.38|-4.66|0.755
91747121|NCT01942668|183385957|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.046||0.802|TWO_SIDED|95.0|-3.5|4.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.53|-3.50|0.802
91747122|NCT01942668|183385957|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|2.043||0.823|TWO_SIDED|95.0|-4.46|3.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-4.46|0.823
91747123|NCT01942668|183385958|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.166||0.255|TWO_SIDED|95.0|-6.71|1.78||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.78|-6.71|0.255
91747124|NCT01942668|183385958|SUPERIORITY||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|2.154||0.293|TWO_SIDED|95.0|-6.49|1.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.96|-6.49|0.293
91747125|NCT01942668|183385958|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.148||0.502|TWO_SIDED|95.0|-5.66|2.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.77|-5.66|0.502
91747126|NCT01942668|183385958|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.161||0.495|TWO_SIDED|95.0|-5.71|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.76|-5.71|0.495
91747127|NCT01942668|183385959|SUPERIORITY||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.274||0.389|TWO_SIDED|95.0|-6.42|2.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.50|-6.42|0.389
91747128|NCT01942668|183385959|SUPERIORITY||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.253||0.281|TWO_SIDED|95.0|-6.85|1.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.99|-6.85|0.281
91747129|NCT01942668|183385959|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.25||0.504|TWO_SIDED|95.0|-5.92|2.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.91|-5.92|0.504
91747130|NCT01942668|183385959|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.277||0.46|TWO_SIDED|95.0|-6.15|2.78||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.78|-6.15|0.460
91747131|NCT01942668|183385960|SUPERIORITY||Mean Difference (Final Values)|4.35|STANDARD_ERROR_OF_MEAN|2.513||0.084|TWO_SIDED|95.0|-0.58|9.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.28|-0.58|0.084
91531644|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
91747132|NCT01942668|183385960|SUPERIORITY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|2.506||0.298|TWO_SIDED|95.0|-2.3|7.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.53|-2.30|0.298
91747133|NCT01942668|183385960|SUPERIORITY||Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|2.496||0.136|TWO_SIDED|95.0|-1.17|8.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.62|-1.17|0.136
91747134|NCT01942668|183385960|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.492||0.163|TWO_SIDED|95.0|-1.41|8.37||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.37|-1.41|0.163
91747135|NCT01942668|183385961|SUPERIORITY||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.647||0.054|TWO_SIDED|95.0|-0.08|10.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.31|-0.08|0.054
91747136|NCT01942668|183385961|SUPERIORITY||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|2.634||0.007|TWO_SIDED|95.0|1.93|12.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||12.26|1.93|0.007
91747137|NCT01942668|183385961|SUPERIORITY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|2.623||0.025|TWO_SIDED|95.0|0.75|11.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.04|0.75|0.025
91747138|NCT01942668|183385961|SUPERIORITY||Mean Difference (Final Values)|8.38|STANDARD_ERROR_OF_MEAN|2.638||0.002|TWO_SIDED|95.0|3.2|13.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||13.55|3.20|0.002
91747139|NCT01942668|183385962|SUPERIORITY||Mean Difference (Final Values)|5.02|STANDARD_ERROR_OF_MEAN|2.945||0.089|TWO_SIDED|95.0|-0.76|10.8||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||10.80|-0.76|0.089
91747140|NCT01942668|183385962|SUPERIORITY||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|2.92||0.01|TWO_SIDED|95.0|1.83|13.29||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||13.29|1.83|0.010
91747141|NCT01942668|183385962|SUPERIORITY||Mean Difference (Final Values)|7.65|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|1.94|13.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.36|1.94|0.009
91747142|NCT01942668|183385962|SUPERIORITY||Mean Difference (Final Values)|7.89|STANDARD_ERROR_OF_MEAN|2.944||0.007|TWO_SIDED|95.0|2.11|13.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.67|2.11|0.007
91747143|NCT01942668|183385963|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.749||0.349|TWO_SIDED|95.0|-5.07|1.79||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.79|-5.07|0.349
91747144|NCT01942668|183385963|SUPERIORITY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|1.743||0.499|TWO_SIDED|95.0|-4.6|2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.24|-4.60|0.499
91747145|NCT01942668|183385963|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.737||0.936|TWO_SIDED|95.0|-3.27|3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-3.27|0.936
91747146|NCT01942668|183385963|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.736||0.696|TWO_SIDED|95.0|-4.08|2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.72|-4.08|0.696
91747147|NCT01942668|183385964|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.924||0.572|TWO_SIDED|95.0|-4.86|2.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.69|-4.86|0.572
91747148|NCT01942668|183385964|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.914||0.553|TWO_SIDED|95.0|-4.89|2.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.62|-4.89|0.553
91747149|NCT01942668|183385964|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.907||0.456|TWO_SIDED|95.0|-5.16|2.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.32|-5.16|0.456
91747150|NCT01942668|183385964|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|1.919||0.949|TWO_SIDED|95.0|-3.89|3.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-3.89|0.949
91747151|NCT01942668|183385965|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.026||0.097|TWO_SIDED|95.0|-7.34|0.61||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.61|-7.34|0.097
91747152|NCT01942668|183385965|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.01||0.008|TWO_SIDED|95.0|-9.28|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.40|-9.28|0.008
91747153|NCT01942668|183385965|SUPERIORITY||Mean Difference (Final Values)|-4.94|STANDARD_ERROR_OF_MEAN|2.003||0.014|TWO_SIDED|95.0|-8.87|-1.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.01|-8.87|0.014
91502562|NCT00827983|182876737|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-3.1||||0.37|TWO_SIDED|95.0|-9.9|3.7|||Chi-squared|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||3.7|-9.9|0.37
91502563|NCT00827983|182876738|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1||||0.37|TWO_SIDED|95.0|-9.87|3.68|||Chi-squared|||||3.68|-9.87|0.37
91502564|NCT00827983|182876739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.33||0.85|TWO_SIDED|95.0|-4.7|5.8|||t-test, 2 sided|||||5.8|-4.7|0.85
91502565|NCT02226003|182876755|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.49|-0.84|||Constrained Longitudinal Data Analysis|||||-0.84|-1.49|< 0.001
91502566|NCT02226003|182876755|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.57|-0.91|||Constrained Longitudinal Data Analysis|||||-0.91|-1.57|< 0.001
91531645|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
91502567|NCT02226003|182876756|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.6|||||TWO_SIDED|95.0|-11.2|16.4||||||||16.4|-11.2|
91502568|NCT02226003|182876756|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.5|||||TWO_SIDED|95.0|-11.4|16.4||||||||16.4|-11.4|
91502569|NCT02226003|182876758|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-38.94|||<|0.001|TWO_SIDED|95.0|-49.93|-27.96|||Constrained Longitudinal Data Analysis|||||-27.96|-49.93|< 0.001
91502570|NCT02226003|182876758|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.05|||<|0.001|TWO_SIDED|95.0|-57.09|-35.02|||Constrained Longitudinal Data Analysis|||||-35.02|-57.09|< 0.001
91502571|NCT02226003|182876759|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-62.42|||<|0.001|TWO_SIDED|95.0|-80.47|-44.37|||Constrained Longitudinal Data Analysis|||||-44.37|-80.47|< 0.001
91502572|NCT02226003|182876759|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-69.65|||<|0.001|TWO_SIDED|95.0|-87.83|-51.46|||Constrained Longitudinal Data Analysis|||||-51.46|-87.83|< 0.001
91502573|NCT02226003|182876760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|2.81|16.83|||Logistic regression model|||||16.83|2.81|< 0.001
91502574|NCT02226003|182876760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.001|TWO_SIDED|95.0|2.98|18.31|||Logistic regression model|||||18.31|2.98|< 0.001
91502575|NCT02226003|182876761|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.0|||<|0.001|TWO_SIDED|95.0|-2.99|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-2.99|< 0.001
91502576|NCT02226003|182876761|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.11|||Constrained Longitudinal Data Analysis|||||-1.11|-3.10|< 0.001
91502577|NCT02226003|182876762|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-4.44||||0.011|TWO_SIDED|95.0|-7.87|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-7.87|0.011
91502578|NCT02226003|182876762|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-6.39|||<|0.001|TWO_SIDED|95.0|-9.83|-2.95|||Constrained Longitudinal Data Analysis|||||-2.95|-9.83|< 0.001
91502579|NCT02226003|182876763|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.65||||0.184|TWO_SIDED|95.0|-4.09|0.79|||Constrained Longitudinal Data Analysis|||||0.79|-4.09|0.184
91502580|NCT02226003|182876763|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.18||||0.08|TWO_SIDED|95.0|-4.62|0.26|||Constrained Longitudinal Data Analysis|||||0.26|-4.62|0.080
91502581|NCT01876485|182876764|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||0.003
91502582|NCT01876485|182876764|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.6|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||.60
91502583|NCT01876485|182876765|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||0.003
91502584|NCT01876485|182876765|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||.003
91502585|NCT02446990|182876780|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.06||0.1969|TWO_SIDED|95.0|0.96|1.2|||Regression, Cox|||||1.2|0.96|0.1969
91502586|NCT02446990|182876781|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.07||0.3461|TWO_SIDED|95.0|0.94|1.21|||Regression, Cox|||||1.21|0.94|0.3461
91502587|NCT02446990|182876782|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.1|STANDARD_ERROR_OF_MEAN|0.09||0.2493|TWO_SIDED|95.0|0.94|1.28|||Regression, Cox|||||1.28|0.94|0.2493
91502588|NCT02446990|182876783|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5162|TWO_SIDED|95.0|0.89|1.26|||Regression, Cox|||||1.26|0.89|0.5162
91502589|NCT02446990|182876784|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.35|STANDARD_ERROR_OF_MEAN|0.29||0.1647|TWO_SIDED|95.0|0.88|2.05|||Regression, Cox|||||2.05|0.88|0.1647
91502590|NCT02446990|182876785|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.04|STANDARD_ERROR_OF_MEAN|0.08||0.6024|TWO_SIDED|95.0|0.9|1.21|||Regression, Cox|||||1.21|0.90|0.6024
91502591|NCT02446990|182876786|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.1458|TWO_SIDED|95.0|0.75|1.04|||Regression, Cox|||||1.04|0.75|0.1458
91502592|NCT02446990|182876787|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.979|TWO_SIDED|95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9790
91747154|NCT01942668|183385965|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.029||0.056|TWO_SIDED|95.0|-7.86|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-7.86|0.056
91502593|NCT02446990|182876788|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.4299|TWO_SIDED|95.0|0.92|1.22|||Regression, Cox|||||1.22|0.92|0.4299
91502594|NCT02446990|182876789|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5916|TWO_SIDED|95.0|0.88|1.08|||Regression, Cox|||||1.08|0.88|0.5916
91502595|NCT02446990|182876790|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.98||||0.6963|TWO_SIDED|95.0|0.89|1.08|||Regression, Cox|||||1.08|0.89|0.6963
91502596|NCT02446990|182876791|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.2222|TWO_SIDED|95.0|0.96|1.18|||Regression, Cox|||||1.18|0.96|0.2222
91502597|NCT02446990|182876792|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.3671|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.3671
91502598|NCT02446990|182876793|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5285|TWO_SIDED|95.0|0.87|1.07|||Regression, Cox|||||1.07|0.87|0.5285
91502599|NCT01064401|182876794|SUPERIORITY_OR_OTHER||Rate Ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.469|0.645||Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|||||0.645|0.469|< 0.0001
91502600|NCT01064401|182876794|SUPERIORITY_OR_OTHER||Percent Reduction|45.0|||||TWO_SIDED|95.0|35.5|53.1||||||||53.1|35.5|
91502601|NCT01064401|182876795|SUPERIORITY_OR_OTHER||Percent Reduction|54.4|||<|0.0001|TWO_SIDED|95.0|46.9|60.8||Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.||||60.8|46.9|< 0.0001
91502602|NCT01064401|182876796|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.1575|TWO_SIDED|95.0|0.66|1.07||Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||1.07|0.66|0.1575
91502603|NCT01064401|182876796|SUPERIORITY_OR_OTHER||Percent Reduction|16.1|||||TWO_SIDED|95.0|-7.0|34.2||||||||34.2|-7.0|
91502604|NCT01064401|182876797|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.69||Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||0.69|0.50|< 0.0001
91502605|NCT01064401|182876797|SUPERIORITY_OR_OTHER||Percent Reduction in Risk of Relapse|40.9|||||TWO_SIDED|95.0|30.8|49.5||||||||49.5|30.8|
91502606|NCT01064401|182876798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.0176|TWO_SIDED|95.0|0.6|0.95||Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Regression, Logistic|||||0.95|0.60|0.0176
91747155|NCT01942668|183385966|SUPERIORITY||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|1.665||0.003|TWO_SIDED|95.0|-8.18|-1.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.65|-8.18|0.003
91747156|NCT01942668|183385966|SUPERIORITY||Mean Difference (Final Values)|-3.79|STANDARD_ERROR_OF_MEAN|1.66||0.023|TWO_SIDED|95.0|-7.05|-0.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.53|-7.05|0.023
91747157|NCT01942668|183385966|SUPERIORITY||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|1.653||0.047|TWO_SIDED|95.0|-6.52|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.04|-6.52|0.047
91747158|NCT01942668|183385966|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.652||0.039|TWO_SIDED|95.0|-6.65|-0.17||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.17|-6.65|0.039
91747159|NCT01942668|183385967|SUPERIORITY||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.713|<|0.001|TWO_SIDED|95.0|-9.05|-2.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.33|-9.05|<0.001
91747160|NCT01942668|183385967|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|1.704||0.001|TWO_SIDED|95.0|-8.93|-2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.24|-8.93|0.001
91747161|NCT01942668|183385967|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.697||0.003|TWO_SIDED|95.0|-8.45|-1.79||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.79|-8.45|0.003
91747162|NCT01942668|183385967|SUPERIORITY||Mean Difference (Final Values)|-5.11|STANDARD_ERROR_OF_MEAN|1.708||0.003|TWO_SIDED|95.0|-8.46|-1.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.76|-8.46|0.003
91747163|NCT01942668|183385968|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|1.885||0.001|TWO_SIDED|95.0|-9.71|-2.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.32|-9.71|0.001
91747164|NCT01942668|183385968|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|1.871|<|0.001|TWO_SIDED|95.0|-10.89|-3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.55|-10.89|<0.001
91747165|NCT01942668|183385968|SUPERIORITY||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.58|-3.27||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.27|-10.58|<0.001
91531646|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
91747166|NCT01942668|183385968|SUPERIORITY||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.886|<|0.001|TWO_SIDED|95.0|-10.12|-2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.72|-10.12|<0.001
91747167|NCT01942668|183385969|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.609||0.004|TWO_SIDED|95.0|-7.75|-1.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.44|-7.75|0.004
91747168|NCT01942668|183385969|SUPERIORITY||Mean Difference (Final Values)|-3.49|STANDARD_ERROR_OF_MEAN|1.605||0.03|TWO_SIDED|95.0|-6.64|-0.34||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.34|-6.64|0.030
91747169|NCT01942668|183385969|SUPERIORITY||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.598||0.049|TWO_SIDED|95.0|-6.29|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.02|-6.29|0.049
91747170|NCT01942668|183385969|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|1.597||0.121|TWO_SIDED|95.0|-5.61|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.61|0.121
91747171|NCT01942668|183385970|SUPERIORITY||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|1.682||0.001|TWO_SIDED|95.0|-8.74|-2.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.14|-8.74|0.001
91747172|NCT01942668|183385970|SUPERIORITY||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-8.81|-2.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.25|-8.81|<0.001
91502607|NCT01064401|182876798|SUPERIORITY_OR_OTHER||Percent Reduction in Odds of Worsening|24.2|||||TWO_SIDED|95.0|4.7|39.6||||||||39.6|4.7|
91502608|NCT03649711|182876842|OTHER|Post treatment values were compared using ANCOVA||||||0.002|||||||ANCOVA|||||||0.002
91502609|NCT03649711|182876842|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||mean changes in values were compared by Wilcoxon rank sum test adjusted for multiple comparisons (Bonferonni method) between CKD-ticagrelor arm, and the non-CKD controls||||0.18
91502610|NCT03649711|182876843|OTHER|||||||0.22|||||||ANCOVA|||CKD groups randomized were compared for post treatment values.||||0.22
91502611|NCT03628703|182876844|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
91502612|NCT02117999|182876850|NON_INFERIORITY|Sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D.|||||<|0.05|||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values. The relationship between the change in Kmax at 12 months and baseline parameters was assessed using Pearson's correlation analysis for either group.||||<0.05
91502613|NCT02117999|182876851|NON_INFERIORITY|sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D. The sample size of the study was 34 cases (allocation ratio of 2:1)|Mean Difference (Final Values)|35.0||||0.05|TWO_SIDED||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.||||0.05
91502614|NCT01331148|182876856|OTHER|||||||0.0507|||||||t-test, 2 sided|||Due to the longitudinal nature of the data and presence of missing values, repeated measures analyses were conducted using the MIXED procedure in SAS. Spearman's rank correlation coefficient was used to quantify the relationship between PedsQL scores with 25OHD concentrations and pain days. Two-way analysis of variance models compared PedsQL scores between treatment groups over time.||||0.0507
91502615|NCT01280552|182876870|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Stratified for age and MGMT methylation status|Log Rank|||Stratified log rank p value stratified for age and MGMT methylation status||||0.010
91502616|NCT01280552|182876872|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Analyses were stratified for age and MGMT methylation status.|Log Rank|||||||0.033
91502617|NCT00887354|182876882|SUPERIORITY_OR_OTHER_LEGACY||LS Mean|0.04|||<|0.0001|TWO_SIDED|95.0|0.025|0.055|||Mixed Models Analysis|||||0.055|0.025|<.0001
91747173|NCT01942668|183385970|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.667||0.002|TWO_SIDED|95.0|-8.39|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.85|-8.39|0.002
91747174|NCT01942668|183385970|SUPERIORITY||Mean Difference (Final Values)|-4.64|STANDARD_ERROR_OF_MEAN|1.677||0.006|TWO_SIDED|95.0|-7.93|-1.35||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.35|-7.93|0.006
91747175|NCT01942668|183385971|SUPERIORITY||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|1.849|<|0.001|TWO_SIDED|95.0|-9.91|-2.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.65|-9.91|<0.001
91502618|NCT01010906|182876913|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.|Geometric Least-Square Mean Ratio|1.82|||||TWO_SIDED|90.0|0.96|3.43||||||||3.43|0.96|
91747176|NCT01942668|183385971|SUPERIORITY||Mean Difference (Final Values)|-7.58|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.18|-3.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.98|-11.18|<0.001
91502619|NCT01010906|182876913|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.|Geometric Least-Square Mean Ratio|3.11|||||TWO_SIDED|90.0|1.6|6.04||||||||6.04|1.60|
91502620|NCT01010906|182876913|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.|Geometric Least-Square Mean Ratio|8.42|||||TWO_SIDED|90.0|5.2|13.64||||||||13.64|5.20|
91502621|NCT01010906|182876914|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|1.57|||||TWO_SIDED|90.0|0.76|3.24||||||||3.24|0.76|
91502622|NCT01010906|182876914|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|2.21|||||TWO_SIDED|90.0|1.21|4.03||||||||4.03|1.21|
91502623|NCT01010906|182876914|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|6.16|||||TWO_SIDED|90.0|3.9|9.71||||||||9.71|3.90|
91502624|NCT03739112|182876938|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for relative vaccine efficacy (VE) was \> -20%.|percent VE|8.8|||||TWO_SIDED|95.0|-16.7|28.7|||||VE of VLP vaccine versus Fluarix = (1-ARVv/ARVc) x 100% where ARVv = attack rate in participants vaccinated with the Quadrivalent VLP Influenza vaccine and ARVc = attack rate in participants vaccinated with an active Fluarix.|||28.7|-16.7|
91502625|NCT03054857|182876986|SUPERIORITY||Risk Ratio (RR)|1.532||||0.289|TWO_SIDED|95.0|0.689|3.406|||Chi-squared|||||3.406|0.689|0.289
91502626|NCT03054857|182876987|SUPERIORITY||Risk Ratio (RR)|1.329||||0.636|TWO_SIDED|95.0|0.409|4.319|||Chi-squared|||||4.319|0.409|0.636
91502627|NCT03054857|182876989|SUPERIORITY||Mean Difference (Final Values)|-1.053|STANDARD_DEVIATION|0.792||0.187|TWO_SIDED|95.0|-2.626|0.52|||t-test, 2 sided|||||0.52|-2.626|0.187
91502628|NCT03054857|182876990|SUPERIORITY||Mean Difference (Final Values)|-4.644|STANDARD_DEVIATION|7.606||0.543|TWO_SIDED|95.0|-19.74|10.45|||t-test, 2 sided|||||10.45|-19.74|0.543
91502629|NCT02529137|182877002|NON_INFERIORITY|the non-inferiority margin was set at 4%|difference|0.4|||||TWO_SIDED|95.0|-0.3|1.01||||||||1.01|-0.30|
91502630|NCT01344447|182877022|SUPERIORITY_OR_OTHER||Percentage difference|22.3|||<|0.0001|TWO_SIDED|95.1|20.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.4|<0.0001
91531647|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
91747177|NCT01942668|183385971|SUPERIORITY||Mean Difference (Final Values)|-7.43|STANDARD_ERROR_OF_MEAN|1.828|<|0.001|TWO_SIDED|95.0|-11.02|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.02|<0.001
91747178|NCT01942668|183385971|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.851|<|0.001|TWO_SIDED|95.0|-10.17|-2.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.91|-10.17|<0.001
91747179|NCT01942668|183385972|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.049||0.225|TWO_SIDED|95.0|-0.04|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.04|0.225
91747180|NCT01942668|183385972|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.049||0.741|TWO_SIDED|95.0|-0.08|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.08|0.741
91747181|NCT01942668|183385972|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.049||0.414|TWO_SIDED|95.0|-0.06|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.06|0.414
91747182|NCT01942668|183385972|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.049||0.69|TWO_SIDED|95.0|-0.11|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.08|-0.11|0.690
91747183|NCT01942668|183385973|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.045|TWO_SIDED|95.0|0.0|0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|0.00|0.045
91747184|NCT01942668|183385973|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.069|TWO_SIDED|95.0|-0.01|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.20|-0.01|0.069
91747185|NCT01942668|183385973|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.052||0.126|TWO_SIDED|95.0|-0.02|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.02|0.126
91747186|NCT01942668|183385973|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.052||0.907|TWO_SIDED|95.0|-0.1|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.10|0.907
91747187|NCT01942668|183385974|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.992|TWO_SIDED|95.0|-0.11|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.11|-0.11|0.992
91747188|NCT01942668|183385974|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.054||0.45|TWO_SIDED|95.0|-0.07|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.07|0.450
91747189|NCT01942668|183385974|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.663|TWO_SIDED|95.0|-0.13|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.13|0.663
91747190|NCT01942668|183385974|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.309|TWO_SIDED|95.0|-0.16|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.16|0.309
91747191|NCT00473668|183386007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|-1.18|||||TWO_SIDED|95.0|-6.39|2.84||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||2.84|-6.39|
91747192|NCT00473668|183386007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|0.0|||||TWO_SIDED|95.0|-4.16|3.99||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||3.99|-4.16|
91747193|NCT02226562|183386022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0001|TWO_SIDED|95.0|-1.28|-0.92||The P-value was less than 0.0001|ANCOVA|ANCOVA with a factor for treatment and baseline as covariate||||-0.92|-1.28|0.0001
91747194|NCT01466660|183386044|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.0891|TWO_SIDED|95.0|0.655|1.032||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by Epidermal Growth Factor Receptor (EGFR) mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.032|0.655|0.0891
91747195|NCT01466660|183386045|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0136|TWO_SIDED|95.0|0.595|0.944||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.944|0.595|0.0136
91747196|NCT01466660|183386046|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.862||||0.2343|TWO_SIDED|95.0|0.674|1.101||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.101|0.674|0.2343
91502631|NCT01344447|182877022|SUPERIORITY_OR_OTHER||Percentage difference|63.8|||<|0.0001|TWO_SIDED|95.1|60.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||60.9|<0.0001
91502632|NCT01344447|182877022|SUPERIORITY_OR_OTHER||Percentage difference|19.6|||<|0.0001|TWO_SIDED|95.1|17.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||17.8|<0.0001
91747197|NCT01466660|183386047|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.307||||0.3235|TWO_SIDED|95.0|0.768|2.223||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.223|0.768|0.3235
91747198|NCT01466660|183386050|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.138||||0.7856|TWO_SIDED|95.0|0.447|2.896||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.896|0.447|0.7856
91747199|NCT01466660|183386052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.45|STANDARD_ERROR_OF_MEAN|1.87||0.0657|TWO_SIDED|95.0|-7.13|0.23||p-value was not adjusted for multiple comparisons|ANCOVA|Adjusted for baseline sum of diameters, EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.23|-7.13|0.0657
91747200|NCT01466660|183386053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.1422|TWO_SIDED|95.0|-0.06|0.01||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|"EQ-5D UK utility score.~Exploratory trial, no formal hypotheses were tested."||0.01|-0.06|0.1422
91747201|NCT01466660|183386053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.054|TWO_SIDED|95.0|-0.06|0.0||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-5D Belgium utility score.~Exploratory trial, no formal hypotheses were tested."||0.00|-0.06|0.0540
91747202|NCT01466660|183386053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.2032|TWO_SIDED|95.0|-3.9|0.8||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-VAS utility score.~Exploratory trial, no formal hypotheses were tested."||0.8|-3.9|0.2032
91747203|NCT03576066|183386054|OTHER|||||||0.6855|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.6855
91531648|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-15.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-15.0|<0.001
91747204|NCT03576066|183386054|OTHER|||||||0.175|||||||Repeated measures analysis|||LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.1750
91747205|NCT03576066|183386055|OTHER|||||||0.2916|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.2916
91747206|NCT00129701|183386068|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||||||0.064
91747207|NCT00191724|183386100|SUPERIORITY_OR_OTHER|||||||0.528||95.0||||P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6|Regression, Linear|||||||0.528
91747208|NCT00191724|183386100|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90|Regression, Linear|||||||0.230
91747209|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Dyspnea 90-Day Follow-Up.|Regression, Linear|||||||0.018
91747210|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value for Emotional 90 Day Follow-up.|Regression, Linear|||||||0.720
91502633|NCT01344447|182877022|SUPERIORITY_OR_OTHER||Percentage difference|15.0|||<|0.0001|TWO_SIDED|95.1|13.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.3|<0.0001
91502634|NCT01344447|182877022|SUPERIORITY_OR_OTHER||Percentage difference|18.5|||<|0.0001|TWO_SIDED|95.1|16.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||16.5|<0.0001
91502635|NCT01344447|182877023|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.7|||||TWO_SIDED|95.1|-3.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-3.6|
91502636|NCT01344447|182877023|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-5.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.4|
91502637|NCT01344447|182877023|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-4.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-4.7|
91502638|NCT01344447|182877023|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.2|||||TWO_SIDED|95.1|-5.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.9|
91502639|NCT01344447|182877023|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|21.5|||||TWO_SIDED|95.1|14.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.1|
91747211|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.481||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.481
91747212|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.161
91747213|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.068
91502640|NCT01344447|182877024|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|8.8|||||TWO_SIDED|95.1|7.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.7|
91502641|NCT01344447|182877024|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|30.3|||||TWO_SIDED|95.1|28.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||28.6|
91502642|NCT01344447|182877024|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.1|8.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||8.5|
91502643|NCT01344447|182877024|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|7.6|||||TWO_SIDED|95.1|6.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||6.6|
91747214|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.985
91747215|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value for Fatigue 90 Day Follow-Up|Regression, Linear|||||||0.281
91747216|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Mastery 90 Day Follow-Up|Regression, Linear|||||||0.273
91502644|NCT01344447|182877024|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.1|||||TWO_SIDED|95.1|7.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.9|
91502645|NCT01344447|182877025|SUPERIORITY_OR_OTHER||percentage|61.7|||||ONE_SIDED|95.1|55.3||||One sided 95.1% confidence interval|||Majority reader|||55.3|
91502646|NCT01344447|182877025|SUPERIORITY_OR_OTHER||percentage|60.3|||||ONE_SIDED|95.1|53.6||||One sided 95.1% confidence interval|||Blinded Reader 1|||53.6|
91502647|NCT01344447|182877025|SUPERIORITY_OR_OTHER||percentage|59.6|||||ONE_SIDED|95.1|53.1||||One sided 95.1% confidence interval|||Blinded Reader 2|||53.1|
91502648|NCT01344447|182877025|SUPERIORITY_OR_OTHER||percentage|58.7|||||ONE_SIDED|95.1|52.2||||One sided 95.1% confidence interval|||Blinded Reader 3|||52.2|
91502649|NCT01344447|182877025|SUPERIORITY_OR_OTHER||percentage|61.5|||||ONE_SIDED|95.1|56.7||||One sided 95.1% confidence interval|||Clinical investigator|||56.7|
91502650|NCT01344447|182877026|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Majority reader|||97.7|
91502651|NCT01344447|182877026|SUPERIORITY_OR_OTHER||percentage|97.6|||||ONE_SIDED|95.1|97.3||||One sided 95.1% confidence interval|||Blinded Reader 1|||97.3|
91502652|NCT01344447|182877026|SUPERIORITY_OR_OTHER||percentage|97.2|||||ONE_SIDED|95.1|96.9||||One sided 95.1% confidence interval|||Blinded Reader 2|||96.9|
91502653|NCT01344447|182877026|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Blinded Reader 3|||97.7|
91747217|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.848
91747218|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.841||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.841
91747219|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.797
91747220|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.963
91747221|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.149
91747222|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.141
91747223|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.774
91747224|NCT00191724|183386101|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.394
91747225|NCT00608023|183386103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91747226|NCT00608023|183386104|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
91747227|NCT00608023|183386105|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
91747228|NCT00608023|183386106|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
91747229|NCT00608023|183386107|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
91747230|NCT00489736|183386115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.0001||95.0|1.28|1.98||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of treatment failure for the dronedarone group compared with the amiodarone group.|||1.98|1.28|<0.0001
91747231|NCT00489736|183386116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.13||95.0|0.6|1.07||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of main safety event occurrence for the dronedarone group compared with the amiodarone group.|||1.07|0.60|0.13
91747232|NCT00489736|183386117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.002||95.0|0.44|0.84||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of MSE occurrence excluding gastrointestinal events, for the dronedarone group compared with the amiodarone group.|||0.84|0.44|0.002
91747233|NCT03458910|183386135|SUPERIORITY|||||||0.782|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.782
91747234|NCT03458910|183386136|SUPERIORITY|||||||0.48|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.480
91747235|NCT03458910|183386137|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.410
91747236|NCT03458910|183386138|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.480
91747237|NCT03458910|183386139|SUPERIORITY|||||||0.17|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for younger adults||||0.170
91747238|NCT03458910|183386140|SUPERIORITY|||||||0.478|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for older adults||||0.478
91747239|NCT03458910|183386141|SUPERIORITY|||||||0.441|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for younger adults||||0.441
91747240|NCT03458910|183386142|SUPERIORITY|||||||0.621|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for older adults||||0.621
91747241|NCT03458910|183386143|SUPERIORITY|||||||0.19|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for younger adults||||0.190
91747242|NCT03458910|183386144|SUPERIORITY|||||||0.864|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for older adults||||0.864
91747243|NCT03458910|183386145|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of fair offers||||1.000
91747244|NCT03458910|183386145|SUPERIORITY|||||||0.716|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of unfair offers||||0.716
91747245|NCT03458910|183386146|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for dorsal anterior cingulate cortex activation.||||0.014
91747246|NCT03458910|183386146|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for anterior insula activation.||||0.059
91747247|NCT03458910|183386147|SUPERIORITY|||||||0.144|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.144
91502654|NCT01344447|182877026|SUPERIORITY_OR_OTHER||percentage|99.2|||||ONE_SIDED|95.1|98.9||||One sided 95.1% confidence interval|||Clinical investigator|||98.9|
91502655|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.21|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
91747248|NCT03458910|183386147|SUPERIORITY|||||||0.653||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|||||||0.653
91747249|NCT03458910|183386148|SUPERIORITY|||||||0.288|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.288
91747250|NCT03458910|183386148|SUPERIORITY|||||||0.191||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.191
91747251|NCT03458910|183386149|SUPERIORITY|||||||0.894|||||||ANOVA|||||||0.894
91747252|NCT03458910|183386149|SUPERIORITY|||||||0.425||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.425
91747253|NCT03458910|183386150|SUPERIORITY|||||||0.916|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.916
91502656|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.0|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
91502657|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.29|STANDARD_DEVIATION|0.87|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
91502658|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.01|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
91502659|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.48|STANDARD_DEVIATION|0.98|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point||||
91502660|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.33|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point||||
91502661|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.02|STANDARD_DEVIATION|0.81|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point||||
91502662|NCT01344447|182877027|SUPERIORITY_OR_OTHER||Diameter difference|0.11|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point||||
91502663|NCT02357901|182877053|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
91502664|NCT02357901|182877053|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
91502665|NCT02357901|182877054|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
91502666|NCT02357901|182877054|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
91502667|NCT02357901|182877055|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
91502668|NCT02357901|182877055|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
91502669|NCT02357901|182877056|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
91502670|NCT02357901|182877056|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
91502671|NCT02357901|182877057|SUPERIORITY||LSM difference|-9.4|STANDARD_ERROR_OF_MEAN|2.62||0.0003|TWO_SIDED|95.0|-14.56|-4.3||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-4.30|-14.56|0.0003
91502672|NCT02357901|182877057|SUPERIORITY||LSM difference|-12.4|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-17.51|-7.28||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-7.28|-17.51|<0.0001
91502673|NCT02357901|182877058|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
91502674|NCT02357901|182877058|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
91502675|NCT02357901|182877059|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
91502676|NCT02357901|182877059|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
91502677|NCT02357901|182877060|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.46||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.46|-0.96|<0.0001
91502678|NCT02357901|182877060|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.12|-0.62||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.62|-1.12|<0.0001
91502679|NCT02357901|182877061|SUPERIORITY||LSM difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.33||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.33|-0.89|<0.0001
91747254|NCT03458910|183386150|SUPERIORITY|||||||0.235||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.235
91747255|NCT03458910|183386151|SUPERIORITY|||||||0.462|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.462
91747256|NCT03458910|183386151|SUPERIORITY|||||||0.468||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.468
91747257|NCT03458910|183386152|SUPERIORITY|||||||0.481|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.481
91747258|NCT03458910|183386152|SUPERIORITY|||||||0.159||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.159
91747259|NCT03458910|183386153|SUPERIORITY|||||||0.602|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.602
91747260|NCT03458910|183386153|SUPERIORITY|||||||0.562||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.562
91747261|NCT03458910|183386154|SUPERIORITY|||||||0.697|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.697
91747262|NCT03458910|183386154|SUPERIORITY|||||||0.901||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.901
91747263|NCT03458910|183386155|SUPERIORITY|||||||0.516|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.516
91502680|NCT02357901|182877061|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.41||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.41|-0.97|<0.0001
91531649|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.1||0.019|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.019
91531650|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.007|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.007
91747264|NCT03458910|183386156|SUPERIORITY|||||||0.944|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.944
91747265|NCT03458910|183386157|SUPERIORITY|||||||0.285|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.285
91502681|NCT02357901|182877062|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.3143|TWO_SIDED|95.0|-1.13|0.36||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.36|-1.13|0.3143
91502682|NCT02357901|182877062|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.38||0.0101|TWO_SIDED|95.0|-1.72|-0.23||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.23|-1.72|0.0101
91502683|NCT02357901|182877063|SUPERIORITY||LSM difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0726|TWO_SIDED|95.0|-3.29|0.14||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.14|-3.29|0.0726
91531651|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
91502684|NCT02357901|182877063|SUPERIORITY||LSM difference|-2.6|STANDARD_ERROR_OF_MEAN|0.87||0.0028|TWO_SIDED|95.0|-4.32|-0.9||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.90|-4.32|0.0028
91502685|NCT02357901|182877064|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.81|9.2||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.20|5.81|<0.0001
91747266|NCT03458910|183386158|SUPERIORITY|||||||0.807|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.807
91747267|NCT03458910|183386159|SUPERIORITY||||||<|0.001|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||<0.001
91747268|NCT03458910|183386160|SUPERIORITY|||||||0.74|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.740
91747269|NCT03458910|183386161|SUPERIORITY|||||||0.083|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.083
91747270|NCT03458910|183386162|SUPERIORITY|||||||0.176|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.176
91747271|NCT03458910|183386163|SUPERIORITY|||||||0.325|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.325
91502686|NCT02357901|182877064|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.82|9.21||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.21|5.82|<0.0001
91747272|NCT03458910|183386164|SUPERIORITY|||||||0.751|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.751
91747273|NCT03458910|183386165|SUPERIORITY|||||||0.011|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.011
91747274|NCT03458910|183386166|SUPERIORITY|||||||0.885|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.885
91747275|NCT03458910|183386167|SUPERIORITY|||||||0.259||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.259
91747276|NCT03458910|183386168|SUPERIORITY|||||||0.000146||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.000146
91502687|NCT02759120|182877109|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.83|TWO_SIDED|95.0|0.71|1.53|||Regression, Cox|||||1.53|0.71|0.83
91502688|NCT02759120|182877110|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Regression, Cox|||||1.78|0.70|0.65
91502689|NCT02759120|182877111|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Cox|||||2.17|0.82|0.25
91502690|NCT02759120|182877112|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.13|TWO_SIDED|95.0|0.91|2.01|||Regression, Cox|||||2.01|0.91|0.13
91747277|NCT03458910|183386169|SUPERIORITY|||||||0.463||||||time point x group (2 way) interaction|ANOVA|||||||0.463
91747278|NCT03458910|183386170|SUPERIORITY|||||||0.99||||||time point x group (2 way) interaction|ANOVA|||||||0.990
91747279|NCT03458910|183386171|SUPERIORITY|||||||0.034||||||time point x group (2 way) interaction|ANOVA|||||||0.034
91747280|NCT03458910|183386172|SUPERIORITY|||||||0.398||||||time point x group (2 way) interaction|ANOVA|||||||0.398
91747281|NCT03458910|183386173|SUPERIORITY|||||||0.113||||||time point x group (2 way) interaction|ANOVA|||||||0.113
91502691|NCT02759120|182877113|SUPERIORITY||Risk Ratio (RR)|1.21||||0.4|TWO_SIDED|95.0|0.78|1.89|||Regression, Cox|||||1.89|0.78|0.40
91502692|NCT02759120|182877114|SUPERIORITY||Risk Ratio (RR)|1.29||||0.16|TWO_SIDED|95.0|0.9|1.83|||Regression, Cox|||||1.83|0.90|0.16
91502693|NCT02759120|182877115|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.19|TWO_SIDED|95.0|-0.56|2.83|||Regression, Cox|||||2.83|-0.56|0.19
91502694|NCT02759120|182877116|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.51|TWO_SIDED|95.0|-1.67|3.35|||Regression, Cox|||||3.35|-1.67|0.51
91502695|NCT02759120|182877117|SUPERIORITY||Risk Ratio (RR)|0.71||||0.13|TWO_SIDED|95.0|0.46|1.11|||Regression, Cox|||||1.11|0.46|0.13
91747282|NCT03458910|183386174|SUPERIORITY|||||||0.637||||||time point x group (2 way) interaction|ANOVA|||||||0.637
91747283|NCT03458910|183386175|SUPERIORITY|time x condition interaction in CRP for younger adults||||||0.133|||||||ANOVA|||||||0.133
91747284|NCT03458910|183386176|SUPERIORITY|time x condition interaction in CRP for older adults||||||0.402|||||||ANOVA|||||||0.402
91747285|NCT03458910|183386177|SUPERIORITY|time x condition interaction in cytokine IL-1b for younger adults||||||0.236||||||p value for time x condition interaction effect|ANOVA|||||||0.236
91747286|NCT03458910|183386178|SUPERIORITY|time x condition interaction in cytokine IL-1b for older adults||||||0.6||||||p value for time x condition interaction effect|ANOVA|||||||0.600
91747287|NCT03458910|183386179|SUPERIORITY|time x condition interaction in cytokine IL-6 for younger adults||||||0.788||||||p value for time x condition interaction effect|ANOVA|||||||0.788
91747288|NCT03458910|183386180|SUPERIORITY|time x condition interaction in cytokine IL-6 for older adults||||||0.917||||||p value for time x condition interaction effect|ANOVA|||||||0.917
91747289|NCT03458910|183386181|SUPERIORITY|time x condition interaction in cytokine IL-8 for younger adults||||||0.844||||||p value for time x condition interaction effect|ANOVA|||||||0.844
91747290|NCT03458910|183386182|SUPERIORITY|time x condition interaction in cytokine IL-8 for older adults||||||0.75||||||p value for time x condition interaction effect|ANOVA|||||||0.750
91502696|NCT02759120|182877118|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
91502697|NCT02759120|182877119|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.54|TWO_SIDED|95.0|-0.24|0.46|||Regression, Cox|||||0.46|-0.24|0.54
91502698|NCT02759120|182877120|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-0.79|0.8|||Regression, Linear|||||0.80|-0.79|0.99
91502699|NCT02759120|182877121|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
91502700|NCT02759120|182877122|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.63|TWO_SIDED|95.0|-0.031|0.051|||Regression, Cox|||||0.051|-0.031|0.63
91502701|NCT02759120|182877123|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.15|TWO_SIDED|95.0|-0.007|0.043|||Regression, Cox|||||0.043|-0.007|0.15
91502702|NCT02759120|182877124|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.53|TWO_SIDED|95.0|-1.11|2.15|||Regression, Cox|||||2.15|-1.11|0.53
91502703|NCT02759120|182877125|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.75|TWO_SIDED|95.0|-1.61|2.2|||Regression, Linear|||||2.20|-1.61|0.75
91502704|NCT04302389|182877128|OTHER||||||<|0.001|||||||t-test, 2 sided|||This was a within-subject comparison at two timepoints (baseline, 3 months)||||<0.001
91502705|NCT02063516|182877147|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).||||0.04
91502706|NCT02063516|182877148|SUPERIORITY_OR_OTHER|||||||0.836|TWO_SIDED|95.0|||||Chi-squared|||||||0.836
91502707|NCT02063516|182877149|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 30 minutes to maintain cuff pressure 60cmH2O||||0.0035
91502708|NCT02063516|182877149|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 60 minutes to maintain cuff pressure 60cmH2O||||0.003
91502709|NCT02063516|182877149|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O||||0.0042
91747291|NCT03458910|183386183|SUPERIORITY|time x condition interaction in cytokine TNF-a for younger adults||||||0.074||||||p value for time x condition interaction effect|ANOVA|||||||0.074
91747292|NCT03458910|183386184|SUPERIORITY|time x condition interaction in cytokine TNF-a for older adults||||||0.0505||||||p value for time x condition interaction effect|ANOVA|||||||0.0505
91747293|NCT03458910|183386199|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.022
91747294|NCT03458910|183386200|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.455
91747295|NCT03458910|183386201|SUPERIORITY|||||||0.022|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.022
91747296|NCT03458910|183386202|SUPERIORITY|||||||0.455|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.455
91747297|NCT03458910|183386203|SUPERIORITY|||||||0.462||||||time point x group (2 way) interaction|ANOVA|||||||0.462
91747298|NCT03458910|183386204|SUPERIORITY|||||||0.305||||||time point x group (2 way) interaction|ANOVA|||||||0.305
91747299|NCT03458910|183386205|SUPERIORITY|||||||0.804||||||time point x group (2 way) interaction|ANOVA|||||||0.804
91502710|NCT02063516|182877149|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O||||0.004
91502711|NCT02293655|182877157|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|2.6||0.55|TWO_SIDED||||||t-test, 2 sided|||Compared at Baseline Time point||||0.55
91502712|NCT02293655|182877157|SUPERIORITY||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|2.3||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison at MPH Maintenance Visit (Week 8)||||.30
91502713|NCT02293655|182877157|SUPERIORITY||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.9||0.28|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (Week 9)||||.28
91502714|NCT02293655|182877157|SUPERIORITY||Mean Difference (Final Values)|9.64|STANDARD_ERROR_OF_MEAN|2.5||0|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (Week 10)||||.00
91502715|NCT02293655|182877157|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|3.2||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (Week 12)||||.01
91747300|NCT03458910|183386206|SUPERIORITY|||||||0.141||||||time point x group (2 way) interaction|ANOVA|||||||0.141
91747301|NCT03458910|183386207|SUPERIORITY|||||||0.292||||||time point x group(2 way) interaction|ANOVA|||||||0.292
91747302|NCT03458910|183386208|SUPERIORITY|||||||0.905||||||time point x group (2 way) interaction|ANOVA|||||||0.905
91747303|NCT03458910|183386209|SUPERIORITY|||||||0.641||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for younger adults||||0.641
91747304|NCT03458910|183386210|SUPERIORITY|||||||0.813||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for older adults||||0.813
91747305|NCT03458910|183386211|SUPERIORITY|||||||0.695|||||||ANOVA|||Hits during recognition task for younger adults||||.695
91747306|NCT03458910|183386212|SUPERIORITY|||||||0.27|||||||ANOVA|||Hits during recognition task for older adults||||.270
91747307|NCT03458910|183386213|SUPERIORITY|||||||0.102|||||||ANOVA|||False alarms during recognition task for younger adults||||.102
91747308|NCT03458910|183386214|SUPERIORITY|||||||0.257|||||||ANOVA|||False alarms during recognition task for older adults||||.257
91747309|NCT03458910|183386215|SUPERIORITY|||||||0.067|||||||ANOVA|||Group difference for recall for younger adults||||.067
91747310|NCT03458910|183386216|SUPERIORITY|||||||0.117|||||||ANOVA|||Group difference for recall for older adults||||.117
91747311|NCT03458910|183386217|SUPERIORITY|||||||0.558||||||p value for time x condition interaction effect|ANOVA|||time x condition x collection interaction in cortisol levels for younger adults||||0.558
91502716|NCT02293655|182877158|SUPERIORITY||Mean Difference (Final Values)|36.04|STANDARD_ERROR_OF_MEAN|25.4||0.32|TWO_SIDED||||||t-test, 2 sided|||Compared at baseline timepoint||||.32
91502717|NCT02293655|182877158|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|30.1||0.9|TWO_SIDED||||||t-test, 2 sided|||Compared at Maintenance Time Point (week 8)||||.90
91502718|NCT02293655|182877158|SUPERIORITY||Mean Difference (Final Values)|100.81|STANDARD_ERROR_OF_MEAN|37.5||0.007|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 1 (week 9)||||.007
91502719|NCT02293655|182877158|SUPERIORITY||Mean Difference (Final Values)|49.07|STANDARD_ERROR_OF_MEAN|56.6||0.26|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 2 (week 10)||||.26
91502720|NCT02293655|182877158|SUPERIORITY||Mean Difference (Final Values)|123.9|STANDARD_ERROR_OF_MEAN|37.6||0.01|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 3 (week 12)||||.01
91502721|NCT02293655|182877159|SUPERIORITY||Mean Difference (Final Values)|31.13|STANDARD_ERROR_OF_MEAN|32.9||0.33|TWO_SIDED||||||t-test, 2 sided|||Comparison at Baseline||||.33
91502722|NCT02293655|182877159|SUPERIORITY||Mean Difference (Final Values)|56.86|STANDARD_ERROR_OF_MEAN|29.5||0.06|TWO_SIDED||||||t-test, 2 sided|||Comparison at Maintenance (week 8)||||.06
91502723|NCT02293655|182877159|SUPERIORITY||Mean Difference (Final Values)|108.78|STANDARD_ERROR_OF_MEAN|46.8||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (week 9)||||.05
91502724|NCT02293655|182877159|SUPERIORITY||Mean Difference (Final Values)|118.12|STANDARD_ERROR_OF_MEAN|44.2||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (week 10)||||.008
91502725|NCT02293655|182877159|SUPERIORITY||Mean Difference (Final Values)|77.09|STANDARD_ERROR_OF_MEAN|42.9||0.07|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (week 12)||||.07
91502726|NCT02063854|182877173|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.1346|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.1346
91747312|NCT05275010|183386218|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.08|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.08|0.93|
91747313|NCT05275010|183386219|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.09|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.09|0.93|
91747314|NCT05275010|183386220|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.96|1.12|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.12|0.96|
91502727|NCT02063854|182877173|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.6711|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.6711
91502728|NCT02063854|182877173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.92|0.001||||||||0.001|-1.920|
91502729|NCT02063854|182877173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-2.617|-0.794||||||||-0.794|-2.617|
91502730|NCT02063854|182877173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|-0.166|1.658||||||||1.658|-0.166|
91502731|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-28.18|||<|0.0001|TWO_SIDED|95.0|-33.85|-22.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-22.51|-33.85|<0.0001
91502732|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-25.29|||<|0.0001|TWO_SIDED|95.0|-31.23|-19.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-19.34|-31.23|<0.0001
91502733|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-29.15|||<|0.0001|TWO_SIDED|95.0|-33.15|-25.15|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-25.15|-33.15|<0.0001
91502734|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-22.25|||<|0.0001|TWO_SIDED|95.0|-26.36|-18.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-18.14|-26.36|<0.0001
91502735|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-17.52|||<|0.0001|TWO_SIDED|95.0|-21.54|-13.5|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-13.50|-21.54|<0.0001
91502736|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-15.51|||<|0.0001|TWO_SIDED|95.0|-19.53|-11.49|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-11.49|-19.53|<0.0001
91502737|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-9.74|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||-5.51|-13.97|<0.0001
91502738|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-4.98||||0.0221|TWO_SIDED|95.0|-9.19|-0.76|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||-0.76|-9.19|0.0221
91502739|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-35.38|||<|0.0001|TWO_SIDED|95.0|-38.89|-31.87|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-31.87|-38.89|<0.0001
91502740|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-27.08|||<|0.0001|TWO_SIDED|95.0|-30.6|-23.57|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-23.57|-30.60|<0.0001
91502741|NCT02246673|182877203|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-31.26|||<|0.0001|TWO_SIDED|95.0|-34.77|-27.75|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-27.75|-34.77|<0.0001
91502742|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.27||||0.0002|TWO_SIDED|95.0|12.57|35.98|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||35.98|12.57|0.0002
91502743|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.08||||0.0013|TWO_SIDED|95.0|8.38|31.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||31.79|8.38|0.0013
91502744|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|23.7|||<|0.0001|TWO_SIDED|95.0|14.23|33.17|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||33.17|14.23|<0.0001
91502745|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.37||||0.0008|TWO_SIDED|95.0|8.3|28.44|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||28.44|8.30|0.0008
91502746|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.82||||0.0101|TWO_SIDED|95.0|4.86|32.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||32.79|4.86|0.0101
91502747|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.52||||0.0055|TWO_SIDED|95.0|6.56|34.48|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||34.48|6.56|0.0055
91502748|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|10.36||||0.0065|TWO_SIDED|95.0|3.13|17.59|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||17.59|3.13|0.0065
91502749|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|1.79||||0.614|TWO_SIDED|95.0|-5.37|8.94|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||8.94|-5.37|0.6140
91502750|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|30.83||||0.0002|TWO_SIDED|95.0|15.62|46.04|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||46.04|15.62|0.0002
91502751|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.38||||0.0019|TWO_SIDED|95.0|9.63|39.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||39.14|9.63|0.0019
91502752|NCT02246673|182877204|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|26.35||||0.0009|TWO_SIDED|95.0|11.59|41.11|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||41.11|11.59|0.0009
91502753|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|139.11|||<|0.0001|TWO_SIDED|95.0|93.92|184.31|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||184.31|93.92|<0.0001
91502754|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|174.47|||<|0.0001|TWO_SIDED|95.0|125.52|233.42|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||233.42|125.52|<0.0001
91502755|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|168.03|||<|0.0001|TWO_SIDED|95.0|123.13|212.93|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||212.93|123.13|<0.0001
91502756|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.75|||<|0.0001|TWO_SIDED|95.0|138.04|239.46|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||239.46|138.04|<0.0001
91502757|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|70.43||||0.0005|TWO_SIDED|95.0|33.74|107.12|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||107.12|33.74|0.0005
91531652|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.13|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.13
91747315|NCT05275010|183386221|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.95|1.13|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.13|0.95|
91747316|NCT04478071|183386275|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.084|0.009|||||"Risk difference of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Primary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a lower probability, at treatment day 14, of death (8) or hospitalization, on invasive mechanical ventilation or ECMO (7) or hospitalization, on non-invasive ventilation or high flow oxygen devices (6) on the NIAID-OS. See Statistical Analysis Plan for more details.||0.009|-0.084|
91747317|NCT04478071|183386275|SUPERIORITY||Posterior Probability|0.94|||||TWO_SIDED||||||||Posterior probability of the risk difference of Vadadustat relative to Placebo.|||||
91502758|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|91.5|||<|0.0001|TWO_SIDED|95.0|54.81|128.19|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||128.19|54.81|<0.0001
91502759|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|40.11|||<|0.0001|TWO_SIDED|95.0|25.17|55.05|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||55.05|25.17|<0.0001
91502760|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|15.96||||0.035|TWO_SIDED|95.0|1.2|30.71|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||30.71|1.20|0.0350
91502761|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|236.08|||<|0.0001|TWO_SIDED|95.0|178.29|293.86|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||293.86|178.29|<0.0001
91502762|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|146.2|||<|0.0001|TWO_SIDED|95.0|90.4|202.01|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||202.01|90.40|<0.0001
91502763|NCT02246673|182877205|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|176.57|||<|0.0001|TWO_SIDED|95.0|120.77|232.38|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||232.38|120.77|<0.0001
91502764|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|135.82|||<|0.0001|TWO_SIDED|95.0|93.33|178.32|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||178.32|93.33|<0.0001
91502765|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|178.58|||<|0.0001|TWO_SIDED|95.0|129.25|227.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||227.90|129.25|<0.0001
91502766|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|163.98|||<|0.0001|TWO_SIDED|95.0|120.8|207.16|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||207.16|120.80|<0.0001
91502767|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|169.93|||<|0.0001|TWO_SIDED|95.0|122.82|217.03|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||217.03|122.82|<0.0001
91502768|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|59.6||||0.0007|TWO_SIDED|95.0|28.85|90.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||90.34|28.85|0.0007
91502769|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|73.54|||<|0.0001|TWO_SIDED|95.0|42.79|104.28|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||104.28|42.79|<0.0001
91502770|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|33.7|||<|0.0001|TWO_SIDED|95.0|21.21|46.2|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||46.20|21.21|<0.0001
91502771|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|27.08||||0.0001|TWO_SIDED|95.0|14.58|39.58|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||39.58|14.58|0.0001
91502772|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.83|||<|0.0001|TWO_SIDED|95.0|152.55|225.1|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||225.10|152.55|<0.0001
91502773|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|116.83|||<|0.0001|TWO_SIDED|95.0|81.76|151.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||151.90|81.76|<0.0001
91747318|NCT04478071|183386276|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||"Risk ratio of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Secondary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a higher probability, at treatment day 14, of recovery on the MSOFA scale (MSOFA = 0).||1.1|0.92|
91502774|NCT02246673|182877206|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|151.66|||<|0.0001|TWO_SIDED|95.0|116.59|186.73|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||186.73|116.59|<0.0001
91502775|NCT05413369|182877213|NON_INFERIORITY|The non-inferiority was assessed using the upper bound of the 2-sided 95% confidence interval (CI). Non-inferiority p-value was calculated from a non-inferiority margin of 0.3%.|Least Squares (LS) Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|Treatment groups and randomization stratum of previous oral anti-diabetic drug(OADs) as fixed effects,and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.07|-0.33|<0.001
91502776|NCT05413369|182877214|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|97.5|-0.35|-0.05|||ANCOVA|Treatment groups and randomization stratum of previous as fixed effects, and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.05|-0.35|0.003
91502777|NCT05413369|182877215|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|97.5|-2.32|-0.66|||ANCOVA|Treatment groups, randomization stratums of HbA1c and previous OADs as fixed effects, and baseline body weight continuous value as covariate.||Statistical analysis for change from baseline in body weight||-0.66|-2.32|<0.001
91502778|NCT05413369|182877216|SUPERIORITY||Odds Ratio (OR)|1.89|||<|0.001|TWO_SIDED|97.5|1.25|2.85|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c||Statistical analysis for percentage of participants reaching HbA1c value \<7% at Week 24||2.85|1.25|<0.001
91502779|NCT05413369|182877217|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.79|3.76|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24||3.76|1.79|<0.001
91747319|NCT04478071|183386276|SUPERIORITY||Posterior probability|0.57|||||TWO_SIDED||||||||Posterior probability of the risk ratio of Vadadustat relative to Placebo.|||||
91502780|NCT05413369|182877218|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.52|3.6|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24 and no hypoglycemia during treatment||3.60|1.52|<0.001
91502781|NCT00525733|182877268|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Chi-squared|||||||0.46
91502782|NCT00189228|182877304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||t-test, 2 sided|||This is not a drug study.||||<0.01
91502783|NCT00455429|182877341|SUPERIORITY_OR_OTHER|||||||0.6|||||||Cochran-Mantel-Haenszel|||||||0.600
91502784|NCT00455429|182877341|SUPERIORITY_OR_OTHER|||||||0.822|||||||Cochran-Mantel-Haenszel|||||||0.822
91502785|NCT00455429|182877341|SUPERIORITY_OR_OTHER|||||||0.656|||||||Cochran-Mantel-Haenszel|||||||0.656
91502786|NCT00455429|182877342|SUPERIORITY_OR_OTHER||LS Mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.63||0.427|TWO_SIDED|95.0|-9.7|2.9|||Dunnett-Hsu|||||2.90|-9.70|0.427
91502787|NCT00455429|182877342|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.55||0.922|TWO_SIDED|95.0|-7.37|4.82|||Dunnett-Hsu|||||4.82|-7.37|0.922
91502788|NCT00455429|182877342|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.24||0.919|TWO_SIDED|95.0|-6.49|4.21|||Dunnett-Hsu|||||4.21|-6.49|0.919
91502789|NCT00455429|182877343|SUPERIORITY_OR_OTHER||LS Mean difference|3.7|STANDARD_ERROR_OF_MEAN|8.15||0.941|TWO_SIDED|95.0|-15.83|23.18|||Dunnett-Hsu|||||23.18|-15.83|0.941
91502790|NCT00455429|182877343|SUPERIORITY_OR_OTHER||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|8.07||0.196|TWO_SIDED|95.0|-5.12|33.52|||Dunnett-Hsu|||||33.52|-5.12|0.196
91502791|NCT00455429|182877343|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|7.08||0.096|TWO_SIDED|95.0|-2.0|31.86|||Dunnett-Hsu|||||31.86|-2.00|0.096
91502792|NCT00455429|182877344|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.460
91502793|NCT00455429|182877344|SUPERIORITY_OR_OTHER|||||||0.479|||||||Regression, Logistic|||||||0.479
91502794|NCT00455429|182877344|SUPERIORITY_OR_OTHER|||||||0.462|||||||Regression, Logistic|||||||0.462
91502795|NCT00455429|182877345|SUPERIORITY_OR_OTHER|||||||0.363|||||||Regression, Logistic|||||||0.363
91502796|NCT00455429|182877345|SUPERIORITY_OR_OTHER|||||||0.968|||||||Regression, Logistic|||||||0.968
91502797|NCT00455429|182877345|SUPERIORITY_OR_OTHER|||||||0.501|||||||Regression, Logistic|||||||0.501
91502798|NCT00455429|182877346|SUPERIORITY_OR_OTHER|||||||0.333|||||||Regression, Logistic|||||||0.333
91502799|NCT00455429|182877346|SUPERIORITY_OR_OTHER|||||||0.527|||||||Regression, Logistic|||||||0.527
91502800|NCT00455429|182877346|SUPERIORITY_OR_OTHER|||||||0.353|||||||Regression, Logistic|||||||0.353
91502801|NCT00455429|182877347|SUPERIORITY_OR_OTHER|||||||0.631|||||||Regression, Logistic|||||||0.631
91502802|NCT00455429|182877347|SUPERIORITY_OR_OTHER|||||||0.523|||||||Regression, Logistic|||||||0.523
91502803|NCT00455429|182877347|SUPERIORITY_OR_OTHER|||||||0.101|||||||Regression, Logistic|||||||0.101
91502804|NCT00455429|182877348|SUPERIORITY_OR_OTHER|||||||0.429|||||||Regression, Logistic|||||||0.429
91502805|NCT00455429|182877348|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
91502806|NCT00455429|182877348|SUPERIORITY_OR_OTHER|||||||0.107|||||||Regression, Logistic|||||||0.107
91502807|NCT00455429|182877349|SUPERIORITY_OR_OTHER|||||||0.097|||||||Regression, Logistic|||||||0.097
91502808|NCT00455429|182877349|SUPERIORITY_OR_OTHER|||||||0.077|||||||Regression, Logistic|||||||0.077
91502809|NCT00455429|182877349|SUPERIORITY_OR_OTHER|||||||0.489|||||||Regression, Logistic|||||||0.489
91502810|NCT00455429|182877350|SUPERIORITY_OR_OTHER|||||||0.566|||||||Regression, Logistic|||||||0.566
91502811|NCT00455429|182877350|SUPERIORITY_OR_OTHER|||||||0.382|||||||Regression, Logistic|||||||0.382
91747320|NCT00245050|183386304|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||<|0.05|TWO_SIDED|95.0|0.536|2.16|||Chi-squared|||Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.||2.16|0.536|<0.05
91747321|NCT00245050|183386305|SUPERIORITY_OR_OTHER|||||||0.916||95.0|||||t-test, 2 sided|||||||0.916
91747322|NCT02301546|183386315|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91502812|NCT00455429|182877350|SUPERIORITY_OR_OTHER|||||||0.282|||||||Regression, Logistic|||||||0.282
91502813|NCT00455429|182877351|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
91502814|NCT00455429|182877351|SUPERIORITY_OR_OTHER|||||||0.433|||||||Regression, Logistic|||||||0.433
91502815|NCT00455429|182877351|SUPERIORITY_OR_OTHER|||||||0.29|||||||Regression, Logistic|||||||0.290
91502816|NCT00455429|182877352|SUPERIORITY_OR_OTHER|||||||0.484|||||||Regression, Logistic|||||||0.484
91502817|NCT00455429|182877352|SUPERIORITY_OR_OTHER|||||||0.952|||||||Regression, Logistic|||||||0.952
91502818|NCT00455429|182877352|SUPERIORITY_OR_OTHER|||||||0.35|||||||Regression, Logistic|||||||0.350
91502819|NCT04351087|182877354|EQUIVALENCE|Power analysis based on (MCID) for the KOOS-Pain, alpha 0.05 \& SD 15 points, 88 patients (44/group) would be required to detect a 9-point difference between treatment groups with 80% power. Due to change in regulatory requirements during accrual, enrollment was halted at 79 patients with 71 meeting inclusion criteria. A repeated power calculation demonstrated that the study achieved 56% power to detect a between-group difference in excess of the 9-point MCID for the KOOS-Pain.|Mean Difference (Final Values)|2.17||||0.69|TWO_SIDED|95.0|-8.57|12.92|||t-test, 2 sided|||||12.92|-8.57|0.69
91502820|NCT01412021|182877369|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502821|NCT01412021|182877370|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502822|NCT01412021|182877371|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502823|NCT01412021|182877372|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502824|NCT01412021|182877373|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502825|NCT01412021|182877375|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502826|NCT01412021|182877377|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502827|NCT01412021|182877378|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
91502828|NCT01412021|182877379|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502829|NCT01412021|182877380|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502830|NCT01412021|182877381|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502831|NCT01412021|182877382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502832|NCT01412021|182877383|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502833|NCT01412021|182877384|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502834|NCT01412021|182877385|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502835|NCT01412021|182877386|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502836|NCT01412021|182877387|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502837|NCT01412021|182877389|SUPERIORITY|||||||0.0132|||||||paired t-test|||||||0.0132
91502838|NCT01412021|182877390|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502839|NCT01412021|182877391|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502840|NCT01412021|182877392|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502841|NCT01412021|182877393|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502842|NCT01412021|182877394|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502843|NCT01412021|182877395|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502844|NCT01412021|182877396|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502845|NCT01412021|182877397|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502846|NCT01412021|182877398|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
91502847|NCT02448654|182877401|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.18
91502848|NCT02448654|182877402|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.03
91502849|NCT02448654|182877403|SUPERIORITY|||||||0.037||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.037
91502850|NCT00484939|182877404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
91502851|NCT00484939|182877405|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.||||0.029
91502852|NCT00484939|182877408|SUPERIORITY_OR_OTHER|||||||0.13|||||||Log Rank|||||||0.130
91502853|NCT02404285|182877415|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91502854|NCT02404285|182877417|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91747323|NCT05059301|183386316|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 2) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|1.06|||||TWO_SIDED|95.0|0.94|1.21||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 2 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.21|0.94|
91747324|NCT05059301|183386316|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.04||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.04|0.81|
91502855|NCT06002958|182877441|OTHER||Cohen's d|-0.29|||||TWO_SIDED|95.0|-0.815|0.255|||||Inner|||0.255|-0.815|
91502856|NCT06002958|182877441|OTHER||Cohen's d|0.02|||||TWO_SIDED|95.0|-0.503|0.545|||||Outer|||0.545|-0.503|
91531653|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.047|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-8.0|0.047
91531654|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
91502857|NCT06002958|182877441|OTHER||Cohen's d|-0.32|||||TWO_SIDED|95.0|-0.85|0.225|||||Individual|||0.225|-0.850|
91502858|NCT06002958|182877441|OTHER||Cohen's d|0.01|||||TWO_SIDED|95.0|-0.85|0.534|||||Process|||0.534|-0.850|
91502859|NCT05760300|182877447|OTHER||Geometric Least-squares Mean Ratio|84.5|||||TWO_SIDED|90.0|60.1|119.0|||||Parametric (normal theory) analysis of covariance (ANOVA) model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||119|60.1|
91502860|NCT05760300|182877447|OTHER||Geometric Least-squares Mean Ratio|104.0|||||TWO_SIDED|90.0|80.8|133.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||133|80.8|
91502861|NCT05760300|182877448|OTHER||Geometric Least-squares Mean Ratio|106.0|||||TWO_SIDED|90.0|63.6|175.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||175|63.6|
91502862|NCT05760300|182877448|OTHER||Geometric Least-squares Mean Ratio|108.0|||||TWO_SIDED|90.0|77.8|151.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||151|77.8|
91502863|NCT05760300|182877449|OTHER||Geometric Least-squares Mean Ratio|83.8|||||TWO_SIDED|90.0|67.4|104.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||104|67.4|
91502864|NCT05760300|182877449|OTHER||Geometric Least-squares Mean Ratio|100.0|||||TWO_SIDED|90.0|56.2|179.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||179|56.2|
91502865|NCT05760300|182877450|OTHER||Geometric Least-squares Mean Ratio|96.5|||||TWO_SIDED|90.0|65.1|143.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||143|65.1|
91502866|NCT05760300|182877450|OTHER||Geometric Least-squares Mean Ratio|77.8|||||TWO_SIDED|90.0|42.7|142.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||142|42.7|
91502867|NCT05760300|182877455|OTHER||Geometric Least-squares Mean Ratio|160.0|||||TWO_SIDED|90.0|97.2|263.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||263|97.2|
91502868|NCT05760300|182877455|OTHER||Geometric Least-squares Mean Ratio|65.9|||||TWO_SIDED|90.0|35.0|124.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||124|35.0|
91502869|NCT05760300|182877455|OTHER||Geometric Least-squares Mean Ratio|86.7|||||TWO_SIDED|90.0|53.3|141.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||141|53.3|
91502870|NCT05760300|182877455|OTHER||Geometric Least-squares Mean Ratio|72.6|||||TWO_SIDED|90.0|50.4|105.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||105|50.4|
91502871|NCT05760300|182877456|OTHER||Geometric Least-squares Mean Ratio|139.0|||||TWO_SIDED|90.0|87.8|221.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||221|87.8|
91531655|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.34|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.34
91531656|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.46|TWO_SIDED|95.0|-6.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-6.0|0.46
91747325|NCT05059301|183386316|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 2 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||To demonstrate the clinical equivalence of RSV OA\_Lot 2 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||0.99|0.77|
91747326|NCT00323960|183386342|SUPERIORITY|||||||0.0228||||||For multiple hypothesis testing, we used Bonferroni's correction (with n=3 posterior comparisons).|Chi-squared|To assess proportions we used the χ² test or Fisher's exact test||We calculated that a sample size of 40 patients would be needed in each study group (total 120 patients) to have 80% power for comparison of combination treatments (prednisone plus methotrexate or prednisone plus ciclosporin) with the reference treatment (prednisone alone).||||0.0228
91747327|NCT00323960|183386343|SUPERIORITY||Relative risk|2.45||||0.012|TWO_SIDED|95.0|1.2|5.0|||Log Rank||RR related to prednisone plus methotrexate arm (group 3) versus prednisone alone (group 1) and prednisone plus ciclosporin (group 2).|We used the Kaplan-Meier method to produce survival curves (groups 1 and 2 versus group 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||5.0|1.2|0.012
91502872|NCT05760300|182877456|OTHER||Geometric Least-squares Mean Ratio|66.8|||||TWO_SIDED|90.0|37.3|120.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||120|37.3|
91502873|NCT05760300|182877456|OTHER||Geometric Least-squares Mean Ratio|85.7|||||TWO_SIDED|90.0|54.5|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.5|
91502874|NCT05760300|182877456|OTHER||Geometric Least-squares Mean Ratio|70.3|||||TWO_SIDED|90.0|49.4|100.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||100|49.4|
91502875|NCT05760300|182877457|OTHER||Geometric Least-squares Mean Ratio|84.2|||||TWO_SIDED|90.0|32.7|217.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||217|32.7|
91502876|NCT05760300|182877457|OTHER||Geometric Least-squares Mean Ratio|58.0|||||TWO_SIDED|90.0|30.1|112.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||112|30.1|
91502877|NCT05760300|182877457|OTHER||Geometric Least-squares Mean Ratio|85.6|||||TWO_SIDED|90.0|54.1|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.1|
91747328|NCT00323960|183386344|SUPERIORITY||Relative risk|1.95||||0.009|TWO_SIDED|95.0|1.2|3.15|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (group 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||3.15|1.2|0.009
91747329|NCT00323960|183386345|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone+methotrexate arm or prednisone+ciclosporin versus prednisone alone.|We used the Kaplan-Meier method to produce survival curves (groups 2 and 3 versus group 1) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
91747330|NCT00323960|183386345|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (groups 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
91747331|NCT01153711|183386346|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|168.4|STANDARD_DEVIATION|16.4||1|TWO_SIDED|90.0|155.5|182.4||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||182.4|155.5|1.0000
91747332|NCT01153711|183386347|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|166.1|STANDARD_DEVIATION|16.8||1|TWO_SIDED|90.0|153.6|179.6||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||179.6|153.6|1.0000
91747333|NCT01153711|183386347|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|106.63|STANDARD_DEVIATION|14.7||0.0001|TWO_SIDED|90.0|100.211|113.463||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||113.463|100.211|0.0001
91747334|NCT01153711|183386350|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|144.23|STANDARD_DEVIATION|17.8||0.9986|TWO_SIDED|90.0|133.853|155.417||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||155.417|133.853|0.9986
91747335|NCT01153711|183386350|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|132.87|STANDARD_DEVIATION|18.9||0.8991|TWO_SIDED|90.0|122.732|143.843||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||143.843|122.732|0.8991
91747336|NCT01153711|183386351|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|100.75|STANDARD_DEVIATION|17.9||0.0001|TWO_SIDED|90.0|92.534|109.692||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||109.692|92.534|0.0001
91747337|NCT02152371|183386370|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-0.77|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.97|-0.56|||Mixed Model for Repeated Measures (MMRM)|||||-0.56|-0.97|<.001
91747338|NCT02152371|183386371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-16.73|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-26.02|-7.44|||Mixed Models Analysis|||||-7.44|-26.02|<.001
91747339|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-8.06|STANDARD_ERROR_OF_MEAN|2.95||0.007|TWO_SIDED|95.0|-13.87|-2.25|||Mixed Models Analysis|||Pre-Morning Meal||-2.25|-13.87|.007
91747340|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-17.18|STANDARD_ERROR_OF_MEAN|4.45|<|0.001|TWO_SIDED|95.0|-25.96|-8.4|||Mixed Models Analysis|||Morning Meal 2-Hour Postprandial||-8.40|-25.96|<.001
91747341|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-15.55|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-23.58|-7.52|||Mixed Models Analysis|||Pre-Midday Meal||-7.52|-23.58|<.001
91747342|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-18.15|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.18|-9.12|||Mixed Models Analysis|||Midday Meal 2-Hour Postprandial||-9.12|-27.18|<.001
91747343|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-14.96|STANDARD_ERROR_OF_MEAN|4.55||0.001|TWO_SIDED|95.0|-23.93|-5.99|||Mixed Models Analysis|||Pre-Evening Meal||-5.99|-23.93|.001
91747344|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-21.28|STANDARD_ERROR_OF_MEAN|5.68|<|0.001|TWO_SIDED|95.0|-32.46|-10.1|||Mixed Models Analysis|||Evening Meal 2-Hour Postprandial||-10.10|-32.46|<.001
91747345|NCT02152371|183386372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-19.48|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-28.77|-10.18|||Mixed Models Analysis|||3:00AM (Morning)||-10.18|-28.77|<.001
91747346|NCT02152371|183386373|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.19|-1.64|||Mixed Models Analysis|||||-1.64|-3.19|<.001
91747347|NCT02152371|183386374|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-13.19|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-19.55|-6.84|||MMRM|||||-6.84|-19.55|<.001
91747348|NCT02152371|183386381|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.66|||<|0.001|TWO_SIDED|95.0|3.7|12.0|||Regression, Logistic|||||12.00|3.70|<.001
91747349|NCT02152371|183386381|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|5.71|||<|0.001|TWO_SIDED|95.0|3.35|9.73|||Regression, Logistic|||||9.73|3.35|<.001
91747350|NCT02152371|183386382|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.17|||<|0.001|TWO_SIDED|95.0|2.32|7.47|||Regression, Logistic|||||7.47|2.32|<.001
91747351|NCT02152371|183386383|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.09|6.23|||Regression, Logistic|||||6.23|2.09|<.001
91747352|NCT02152371|183386384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.6|||<|0.001|TWO_SIDED|95.0|3.26|9.62|||Regression, Logistic|||||9.62|3.26|<.001
91502878|NCT05760300|182877457|OTHER||Geometric Least-squares Mean Ratio|69.6|||||TWO_SIDED|90.0|48.9|99.2|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||99.2|48.9|
91502879|NCT05477875|182877462|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||Wilcoxon (Mann-Whitney)|||||||0.538
91502880|NCT05477875|182877463|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||ANOVA|||||||0.538
91502881|NCT05477875|182877464|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
91502882|NCT05477875|182877465|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and PROWL-SS from (1-100) as the dependent variable."|||||<|0.851|||||||ANOVA|||||||<0.851
91502883|NCT05477875|182877466|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and QIRC from (1-100) as the dependent variable."|||||<|0.543|||||||ANOVA|||||||<0.543
91502884|NCT05477875|182877467|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and OSDI from (0-48) as the dependent variable."||||||0.725|||||||ANOVA|||||||0.725
91502885|NCT05477875|182877468|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
91502886|NCT03989440|182877480|SUPERIORITY||LS Mean Difference|0.54||||0.59|TWO_SIDED|95.0|-1.48|2.55|||Mixed Models Analysis|||||2.55|-1.48|0.59
91502887|NCT03989440|182877481|SUPERIORITY||LS Mean Difference|-1.56||||0.13|TWO_SIDED|95.0|-3.62|0.5|||Mixed Models Analysis|||||0.50|-3.62|0.13
91502888|NCT03989440|182877482|SUPERIORITY||LS Mean Difference|-1.16||||0.16|TWO_SIDED|95.0|-2.81|0.5|||Mixed Models Analysis|||||0.50|-2.81|0.16
91502889|NCT03989440|182877483|SUPERIORITY||% Difference in responder rate|-9.3||||0.68|TWO_SIDED|95.0|-43.3|25.4|||Fisher Exact|||||25.4|-43.3|0.68
91502890|NCT01955161|182877484|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.9591|TWO_SIDED|95.0|-0.59|1.26||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.26|-0.59|0.9591
91502891|NCT01955161|182877484|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||1|TWO_SIDED|95.0|-0.88|0.98||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.98|-0.88|1.000
91502892|NCT01955161|182877485|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.37|1.21||Corrected for multiplicity according toe the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.21|-1.37|1.000
91747353|NCT05285644|183386397|OTHER|Difference (2-sided)|Difference in Percentages|34.4|||<|0.0001|TWO_SIDED|95.0|26.9|42.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|42.0|26.9|<0.0001
91747354|NCT05285644|183386398|OTHER|Difference (2-sided)|Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.06||0.0138|TWO_SIDED|95.0|-9.1|-1.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||-1.0|-9.1|0.0138
91513611|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.99|0.80|< 0.001
91747355|NCT05285644|183386399|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|5.8|8.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|8.6|5.8|<0.0001
91747356|NCT05285644|183386400|OTHER|Difference (2-sided)|Difference in Percentages|26.7|||<|0.0001|TWO_SIDED|95.0|19.5|34.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|34.0|19.5|<0.0001
91747357|NCT05285644|183386401|OTHER|Difference (2-sided)|Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|4.9|7.5||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||7.5|4.9|<0.0001
91747358|NCT05285644|183386402|OTHER|Difference (2 sided)|Difference in Percentages|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|41.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|41.4|24.8|<0.0001
91502893|NCT01955161|182877485|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.29|1.31||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.31|-1.29|1.000
91502894|NCT01955161|182877486|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.15|0.2||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.20|-0.15|1.000
91502895|NCT01955161|182877486|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.34|0.02||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.02|-0.34|1.000
91747359|NCT05285644|183386403|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.5|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|6.0|9.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.0|6.0|<0.0001
91747360|NCT05285644|183386404|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.28||0.2184|TWO_SIDED|95.0|-7.3|1.7||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.7|-7.3|0.2184
91747361|NCT05285644|183386405|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.43||0.266|TWO_SIDED|94.0|-7.5|2.1||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.1|-7.5|0.2660
91747362|NCT05285644|183386406|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|2.37||0.2741|TWO_SIDED|95.0|-7.2|2.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.0|-7.2|0.2741
91502896|NCT04608500|182877495|SUPERIORITY||Mean Difference (Final Values)|3.85|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|2.16|5.54|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, Baseline inflammatory lesion count, and analysis center.||||5.54|2.16|<0.0001
91502897|NCT04608500|182877496|SUPERIORITY||Risk Ratio (RR)|1.263||||0.0077|TWO_SIDED|95.0|1.064|1.499||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||||1.499|1.064|0.0077
91502898|NCT04608500|182877497|SUPERIORITY||Risk Ratio (RR)|1.193||||0.0189|TWO_SIDED|95.0|1.024|1.39||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.390|1.024|0.0189
91502899|NCT04608500|182877498|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|2.672|<|0.0001|TWO_SIDED|95.0|6.05|16.54|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||16.54|6.05|<0.0001
91502900|NCT04608500|182877499|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|0.821|<|0.0001|TWO_SIDED|95.0|2.77|5.99|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 4||5.99|2.77|<0.0001
91747363|NCT05285644|183386407|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.43||0.159|TWO_SIDED|95.0|-8.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-8.2|0.1590
91502901|NCT04608500|182877499|SUPERIORITY||Mean Difference (Final Values)|5.07|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|3.52|6.63|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 8||6.63|3.52|<0.0001
91502902|NCT04608500|182877500|SUPERIORITY||Risk Ratio (RR)|1.715||||0.0114|TWO_SIDED|95.0|1.129|2.605||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 4||2.605|1.129|0.0114
91502903|NCT04608500|182877500|SUPERIORITY||Risk Ratio (RR)|1.319||||0.0061|TWO_SIDED|95.0|1.082|1.607||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 8||1.607|1.082|0.0061
91502904|NCT00697515|182877528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91502905|NCT00697515|182877529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||ANOVA|||2.0 hours post-dose||||0.0017
91502906|NCT00697515|182877529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
91502907|NCT00697515|182877529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
91531657|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
91502908|NCT00697515|182877529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
91502909|NCT00697515|182877529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
91502910|NCT00697515|182877529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
91502911|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Average over the treatment day||||<0.0001
91502912|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||2.0 hours post-dose||||0.0010
91502913|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
91502914|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
91502915|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
91502916|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
91502917|NCT00697515|182877530|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
91502918|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Over the treatment day||||<0.0001
91502919|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||ANOVA|||2.0 hours post-dose||||0.0031
91502920|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
91502921|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
91502922|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
91502923|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
91502924|NCT00697515|182877531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
91502925|NCT00697515|182877532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91502926|NCT00697515|182877533|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91502927|NCT00697515|182877536|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Prescott's Test|||||||<0.0001
91502928|NCT00697515|182877537|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91502929|NCT00697515|182877539|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91502930|NCT00697515|182877540|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91531658|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.2||0.03|TWO_SIDED|95.0|-9.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-9.0|0.030
91531659|NCT02886728|182939611|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-12.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-12.0|<0.001
91502931|NCT05954052|182877546|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|9.0||0.1807|TWO_SIDED|95.0|-6.24|14.24|||Wilcoxon (Mann-Whitney)|||For the analysis of (ABC) scores at baseline and 12 weeks in this single-arm, open-label pilot study (n=6 participants, all with paired data including the early dropout), we use superiority test, This aligns with the study's hypothesis that oral glutathione supplementation would lead to an improvement (i.e., a decrease in ABC scores, indicating reduced irritability). Superiority testing evaluates whether the post-treatment mean (or median) is significantly lower than the baseline||14.24|-6.24|0.1807
91502932|NCT05517382|182877609|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||At baseline||||0.20
91502933|NCT05517382|182877609|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||At Post game||||0.59
91502934|NCT05517382|182877609|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||At 3 month||||0.94
91502935|NCT05517382|182877609|SUPERIORITY|||||||0.55|||||||GEE|Controlling for baseline thriving status, this reflects the interaction between the intervention group and time.||||||0.55
91502936|NCT05517382|182877610|SUPERIORITY||Mean Difference (Net)|-0.09||||0.1759|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis||Group effect.|At post game.||0.04|-0.23|0.1759
91502937|NCT05517382|182877610|SUPERIORITY||Mean Difference (Net)|-0.16||||0.0857|TWO_SIDED|95.0|-0.35|0.02|||Mixed Models Analysis||Group effect.|At 3 month||0.02|-0.35|0.0857
91502938|NCT03886220|182877620|SUPERIORITY||Odds Ratio (OR)|3.22||||0.035|TWO_SIDED|95.0|1.086|9.546||P-value for test of difference between elagolix dose group and placebo is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|Regression, Logistic|||||9.546|1.086|0.035
91502939|NCT02461225|182877664|SUPERIORITY||||||<|0.0005|||||||Fisher Exact|||||||<.0005
91502940|NCT02461225|182877665|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91502941|NCT03526458|182877666|SUPERIORITY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|5.6||0.012|TWO_SIDED|95.0|4.4|28.9|||t-test, 2 sided|||||28.9|4.4|0.012
91531660|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-10.78|STANDARD_ERROR_OF_MEAN|0.983|<|0.001|TWO_SIDED|95.0|-12.71|-8.85||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.85|-12.71|<0.001
91502942|NCT03526458|182877667|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.132|TWO_SIDED|95.0|-3.6|26.3|||t-test, 2 sided|||||26.3|-3.6|0.132
91502943|NCT03526458|182877668|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.7||0.654|TWO_SIDED|95.0|-4.4|6.9|||t-test, 2 sided|||||6.9|-4.4|0.654
91502944|NCT03526458|182877669|SUPERIORITY|||||||0.299|||||||Chi-squared|||||||0.299
91502945|NCT03526458|182877670|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
91502946|NCT03526458|182877671|SUPERIORITY||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|143.9||0.943|TWO_SIDED|95.0|-286.0|306.8|||t-test, 2 sided|||||306.8|-286|0.943
91502947|NCT03526458|182877672|SUPERIORITY|||||||0.185|||||||Chi-squared|||||||0.185
91502948|NCT00651755|182877683|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.2|||||TWO_SIDED|90.0|1.08|1.33|||90% CI||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,CP, between Aprepitant treatment to control Group.|||1.33|1.08|
91502949|NCT00651755|182877684|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|ratio Geometric mean AUC|0.75|STANDARD_DEVIATION|0.29|||TWO_SIDED|95.0|0.65|0.86|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group|||0.86|0.65|
91502950|NCT00651755|182877685|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|0.97|STANDARD_DEVIATION|0.35|||TWO_SIDED|90.0|0.83|1.13|||equivalence analysis|The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment to the control group|Ratio Geometric Mean AUC of Analyte, 4-OHCP, between Aprepitant treatment to control Group|||1.13|0.83|
91502951|NCT00651755|182877686|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.04|STANDARD_DEVIATION|0.68|||TWO_SIDED|90.0|0.82|1.33|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte, VC, Between Aprepitant treatment to control Group.|||1.33|0.82|
91502952|NCT00651755|182877687|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.08|STANDARD_DEVIATION|0.17||||90.0|1.02|1.15|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group.|||1.15|1.02|
91502953|NCT00651755|182877688|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|90.0|1.01|1.32|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,PL, Between Aprepitant treatment to control Group.|||1.32|1.01|
91502954|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
91747364|NCT05285644|183386408|OTHER|Difference (2-sided)|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.67||0.1369|TWO_SIDED|95.0|-9.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-9.2|0.1369
91747365|NCT04114071|183386412|EQUIVALENCE|An independent sample t tests was used to examine the difference score for each of the four outcome measures of interest (steps, WC, weight, and HbA1c) between intervention and control groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91747366|NCT01448824|183386421|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS Means|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
91502955|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.78|0.93||||||Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.78|
91747367|NCT01448824|183386422|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon signed rank|||||0.50|-0.50|1.0000
91747368|NCT01448824|183386423|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS means|2.37|||||TWO_SIDED|90.0|1.77|3.18||||||||3.18|1.77|
91747369|NCT02526524|183386445|SUPERIORITY||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.184||0.1449|TWO_SIDED|95.0|-0.63|0.09|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.09|-0.63|0.1449
91747370|NCT02526524|183386445|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0643|TWO_SIDED|95.0|-0.69|0.02|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.02|-0.69|0.0643
91747371|NCT02526524|183386445|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.0214|TWO_SIDED|95.0|-0.79|-0.06|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.06|-0.79|0.0214
91747372|NCT02526524|183386445|SUPERIORITY||LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.18||0.0022|TWO_SIDED|95.0|-0.91|-0.2|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.20|-0.91|0.0022
91747373|NCT02526524|183386445|SUPERIORITY||LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.184|<|0.0001|TWO_SIDED|95.0|-1.39|-0.67|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.67|-1.39|<0.0001
91747374|NCT00100230|183386457|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.3|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.30
91502956|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.71|
91747375|NCT00100230|183386458|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.27
91747376|NCT00100230|183386458|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
91747377|NCT00100230|183386459|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||8e-06|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.000008
91747378|NCT02039219|183386471|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.4||0.1758|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at baseline OCA arms had a mean (SD) of 14.9(2.4), Placebo arms had a mean (SD) of 16.4 (2.2).|Baseline||||0.1758
91747379|NCT02039219|183386471|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|6.8||0.3839|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at day 42 OCA arms had a mean (SD) of 11.5 (6.8), Placebo arms had a mean (SD) of 13.9(4.6).|Day 42||||0.3839
91747380|NCT02039219|183386479|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|ONE_SIDED||||||Log Rank|||Day 42||||.3938
91747381|NCT02039219|183386479|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
91747382|NCT02039219|183386479|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
91747383|NCT02039219|183386479|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 42||||.3938
91747384|NCT02039219|183386479|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
91747385|NCT02039219|183386479|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
91502957|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.74|0.94||||||Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.94|0.74|
91502958|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.66|0.88||||||Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.88|0.66|
91502959|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.73|0.95||||||Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.95|0.73|
91502960|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.86|||||TWO_SIDED|95.0|0.77|0.96||||||Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.96|0.77|
91502961|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.93|||||TWO_SIDED|95.0|0.82|1.05||||||Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.05|0.82|
91502962|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.13|0.89|
91502963|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.74|0.97||||||Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.74|
91502964|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
91531661|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|1.207|<|0.001|TWO_SIDED|95.0|-11.13|-6.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.39|-11.13|<0.001
91747386|NCT02039219|183386483|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.5||0.8094|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.8094
91747387|NCT00967694|183386558|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25||||>0.05
91747388|NCT00729677|183386559|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||.05
91747389|NCT01005316|183386589|SUPERIORITY_OR_OTHER|||||||0.258|||||||Fisher Exact|||The p-value compares Cohort A: Non-Sensitized with Cohort B: Sensitized, Crossmatch Positive.||||0.2580
91747390|NCT03272828|183386613|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
91502965|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.91|0.70|
91747391|NCT03272828|183386614|SUPERIORITY|||||||0.06|||||||Unequal-variance 2-sample t-test|||||||0.06
91502966|NCT03760146|182877726|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.70|
91502967|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.55|||||TWO_SIDED|95.0|0.49|0.62||||||Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.62|0.49|
91747392|NCT03272828|183386615|SUPERIORITY|||||||0.45|||||||Unequal-variance 2-sample t-test|||||||0.45
91747393|NCT03888235|183386617|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.||||0.003
91747394|NCT03888235|183386617|SUPERIORITY|||||||0.001||||||SI Exercise versus usual care. Bonferroni alpha correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||||||0.001
91747395|NCT03888235|183386617|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatment||||0.314
91747396|NCT03888235|183386618|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.||||< 0.001
91747397|NCT03888235|183386619|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.||||0.17
91747398|NCT03888235|183386619|SUPERIORITY|||||||0.089||||||Bonferroni alpha correction of p\<0.0167.|Wilcoxon (Mann-Whitney)|||The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.||||0.089
91747399|NCT03888235|183386619|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment||||0.092
91747400|NCT03888235|183386620|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.||||< 0.001
91747401|NCT03888235|183386621|SUPERIORITY|||||||0.016||||||The Bonferroni alpha correction is used p\<0.0167|Kruskal-Wallis|||The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.||||0.016
91747402|NCT03888235|183386621|SUPERIORITY|||||||0.009||||||The Bonferroni alpha correction is used p\<0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month.||||0.009
91747403|NCT03888235|183386621|SUPERIORITY|||||||0.034||||||Bonferroni correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain.||||0.034
91747404|NCT03888235|183386622|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.||||< 0.0001
91747405|NCT03888235|183386622|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||< 0.001
91747406|NCT03888235|183386623|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
91747407|NCT03888235|183386624|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
91747408|NCT03888235|183386625|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
91747409|NCT03888235|183386626|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
91747410|NCT03888235|183386627|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
91747411|NCT03888235|183386628|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.||||<0.00001
91747412|NCT03703817|183386662|SUPERIORITY|Effectiveness: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.3648|||||||Linear mixed model|||||||0.3648
91747413|NCT03703817|183386662|SUPERIORITY|Side effect: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1395|||||||Conditional logistic regression|||||||0.1395
91747414|NCT03703817|183386662|SUPERIORITY|Convenience: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.0349|||||||Linear mixed model|||||||0.0349
91747415|NCT03703817|183386662|SUPERIORITY|Global satisfaction: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1546|||||||Linear mixed model|||||||0.1546
91747416|NCT03703817|183386663|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1602|||||||Conditional logistic regression model|||||||0.1602
91747417|NCT03703817|183386664|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.9921|||||||Linear mixed model|||||||0.9921
91747418|NCT06359028|183386696|SUPERIORITY||Adjusted Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-2.16|-1.72|||Mixed Model with Repeated Measures|||||-1.72|-2.16|<0.0001
91747419|NCT06359028|183386697|SUPERIORITY||Adjusted Mean Difference|57.37|STANDARD_ERROR_OF_MEAN|3.599|<|0.0001|TWO_SIDED|95.0|50.23|64.51|||Mixed Model with Repeated Measures|||||64.51|50.23|<0.0001
91747420|NCT06359028|183386698|SUPERIORITY||Adjusted Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.89|-1.41|||Mixed Model with Repeated Measures|||||-1.41|-1.89|<0.0001
91747421|NCT06359028|183386699|SUPERIORITY||Adjusted Mean Difference|35.37|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|26.88|43.86|||Mixed Model with Repeated Measures|||||43.86|26.88|<0.0001
91747422|NCT06359028|183386700|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.296||0.1268|TWO_SIDED|95.0|-1.04|0.13|||Mixed Model with Repeated Measures|||Q7, Day 28||0.13|-1.04|0.1268
91747423|NCT06359028|183386700|SUPERIORITY||Adjusted Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.316|<|0.0001|TWO_SIDED|95.0|-2.38|-1.13|||Mixed Model with Repeated Measures|||Q7, Day 56||-1.13|-2.38|<0.0001
91747424|NCT06359028|183386700|SUPERIORITY||Adjusted Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.315||0.0245|TWO_SIDED|95.0|-1.35|-0.09|||Mixed Model with Repeated Measures|||Q8, Day 28||-0.09|-1.35|0.0245
91747425|NCT06359028|183386700|SUPERIORITY||Adjusted Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.318|<|0.0001|TWO_SIDED|95.0|-2.44|-1.18|||Mixed Model with Repeated Measures|||Q8, Day 56||-1.18|-2.44|<0.0001
91747426|NCT06359028|183386700|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.337||0.3851|TWO_SIDED|95.0|-0.96|0.37|||Mixed Model with Repeated Measures|||Q9, Day 28||0.37|-0.96|0.3851
91747427|NCT06359028|183386700|SUPERIORITY||Adjusted Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.375||0.0002|TWO_SIDED|95.0|-2.22|-0.73|||Mixed Model with Repeated Measures|||Q9, Day 56||-0.73|-2.22|0.0002
91747428|NCT06359028|183386701|SUPERIORITY||Adjusted Mean Difference|-6.19|STANDARD_ERROR_OF_MEAN|4.674||0.1884|TWO_SIDED|95.0|-15.46|3.08|||Mixed Model with Repeated Measures|||Day 28||3.08|-15.46|0.1884
91747429|NCT06359028|183386701|SUPERIORITY||Adjusted Mean Difference|-24.49|STANDARD_ERROR_OF_MEAN|6.308||0.0002|TWO_SIDED|95.0|-37.0|-11.97|||Mixed Model with Repeated Measures|||Day 56||-11.97|-37.00|0.0002
91747430|NCT06359028|183386702|SUPERIORITY||Adjusted Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.774||0.3003|TWO_SIDED|95.0|-2.34|0.73|||Mixed Model with Repeated Measures|||Day 28||0.73|-2.34|0.3003
91747431|NCT06359028|183386702|SUPERIORITY||Adjusted Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.903||0.0028|TWO_SIDED|95.0|-4.56|-0.97|||Mixed Model with Repeated Measures|||Day 56||-0.97|-4.56|0.0028
91747432|NCT06359028|183386703|SUPERIORITY||Adjusted Mean Difference|-3.78|STANDARD_ERROR_OF_MEAN|2.127||0.0784|TWO_SIDED|95.0|-8.0|0.44|||Mixed Model with Repeated Measures|||Day 28||0.44|-8.00|0.0784
91747433|NCT06359028|183386703|SUPERIORITY||Adjusted Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|3.074||0.0092|TWO_SIDED|95.0|-14.27|-2.07|||Mixed Model with Repeated Measures|||Day 56||-2.07|-14.27|0.0092
91747434|NCT06359028|183386704|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.846||0.8686|TWO_SIDED|95.0|-1.82|1.54|||Mixed Model with Repeated Measures|||Day 28||1.54|-1.82|0.8686
91747435|NCT06359028|183386704|SUPERIORITY||Adjusted Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.976||0.0012|TWO_SIDED|95.0|-5.18|-1.31|||Mixed Model with Repeated Measures|||Day 56||-1.31|-5.18|0.0012
91747436|NCT06359028|183386705|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|1.444||0.9047|TWO_SIDED|95.0|-3.04|2.69|||Mixed Model with Repeated Measures|||Day 28||2.69|-3.04|0.9047
91747437|NCT06359028|183386705|SUPERIORITY||Adjusted Mean Difference|-6.66|STANDARD_ERROR_OF_MEAN|1.656||0.0001|TWO_SIDED|95.0|-9.95|-3.38|||Mixed Model with Repeated Measures|||Day 56||-3.38|-9.95|0.0001
91502968|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.86|||||TWO_SIDED|95.0|1.63|2.12||||||Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.12|1.63|
91747438|NCT06359028|183386706|SUPERIORITY||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.84||0.5733|TWO_SIDED|95.0|-2.14|1.19|||Mixed Model with Repeated Measures|||Day 28||1.19|-2.14|0.5733
91747439|NCT06359028|183386706|SUPERIORITY||Adjusted Mean Difference|-2.88|STANDARD_ERROR_OF_MEAN|1.026||0.006|TWO_SIDED|95.0|-4.92|-0.84|||Mixed Model with Repeated Measures|||Day 56||-0.84|-4.92|0.0060
91747440|NCT06359028|183386707|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.127||0.2768|TWO_SIDED|95.0|-0.39|0.11|||Mixed Model with Repeated Measures|||Day 28||0.11|-0.39|0.2768
91747441|NCT06359028|183386707|SUPERIORITY||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.113||0.0232|TWO_SIDED|95.0|-0.48|-0.04|||Mixed Model with Repeated Measures|||Day 56||-0.04|-0.48|0.0232
91747442|NCT06359028|183386708|SUPERIORITY||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.403||0.8996|TWO_SIDED|95.0|-0.75|0.85|||Mixed Model with Repeated Measures|||Day 28||0.85|-0.75|0.8996
91747443|NCT06359028|183386708|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.383||0.0204|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Model with Repeated Measures|||Day 56||-0.14|-1.66|0.0204
91747444|NCT05248997|183386712|SUPERIORITY||Difference in least square mean|-0.09||||0.7782|TWO_SIDED|95.0|-0.71|0.53||LM included baseline value as covariate,\& fixed effects for treatment group,stratification factor,scheduled time point(TP),TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.53|-0.71|0.7782
91747445|NCT05248997|183386713|SUPERIORITY||Difference in least square mean|-0.29||||0.7079|TWO_SIDED|95.0|-1.83|1.24||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||1.24|-1.83|0.7079
91747446|NCT05248997|183386714|SUPERIORITY||Difference in least square mean|-0.23||||0.4398|TWO_SIDED|95.0|-0.81|0.36||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.36|-0.81|0.4398
91747447|NCT05248997|183386715|SUPERIORITY||Difference in least square mean|0.04||||0.889|TWO_SIDED|95.0|-0.51|0.59||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.59|-0.51|0.8890
91747448|NCT05248997|183386716|SUPERIORITY||Percentage difference|3.8||||0.6412|TWO_SIDED|95.0|-12.1|19.7|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||19.7|-12.1|0.6412
91747449|NCT05248997|183386717|SUPERIORITY||Percentage difference|-2.7||||0.5001|TWO_SIDED|95.0|-10.6|5.2|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||5.2|-10.6|0.5001
91502969|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.75|||||TWO_SIDED|95.0|1.52|2.01||||||Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.01|1.52|
91502970|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.27|1.72||||||Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.72|1.27|
91502971|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.12|||||TWO_SIDED|95.0|2.62|3.71||||||Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||3.71|2.62|
91747450|NCT00673231|183386732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0726|<|0.0001|TWO_SIDED|95.0|-0.59|-0.31||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.31|-0.59|<0.0001
91747451|NCT00673231|183386732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.0718|<|0.0001|TWO_SIDED|95.0|-0.66|-0.38||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.38|-0.66|<0.0001
91502972|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.99|||||TWO_SIDED|95.0|1.7|2.32||||||Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.32|1.70|
91502973|NCT03760146|182877727|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.38|||||TWO_SIDED|95.0|1.21|1.57||||||Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.57|1.21|
91747452|NCT00673231|183386732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|95.0|-0.74|-0.45||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.45|-0.74|<0.0001
91747453|NCT00673231|183386733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.256||0.0001|TWO_SIDED|95.0|-1.5|-0.49||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-1.50|0.0001
91747454|NCT00673231|183386733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2523|<|0.0001|TWO_SIDED|95.0|-1.5|-0.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.50|-1.50|<0.0001
91747455|NCT00673231|183386733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.2578|<|0.0001|TWO_SIDED|95.0|-2.19|-1.18||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-1.18|-2.19|<0.0001
91747456|NCT00673231|183386734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|STANDARD_ERROR_OF_MEAN|1.3195|<|0.0001|TWO_SIDED|95.0|-9.46|-4.28||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-4.28|-9.46|<0.0001
91747457|NCT00673231|183386734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.3045|<|0.0001|TWO_SIDED|95.0|-8.25|-3.13||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.13|-8.25|<0.0001
91747458|NCT00673231|183386734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.3286|<|0.0001|TWO_SIDED|95.0|-8.84|-3.63||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.63|-8.84|<0.0001
91747459|NCT00673231|183386735|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|3.536||0.0427|TWO_SIDED|95.0|0.2|14.1||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||14.1|0.2|0.0427
91502974|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.84|
91502975|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.92|1.22||||||Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.92|
91502976|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.38|0.87|
91502977|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.72|
91502978|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.21|||||TWO_SIDED|95.0|0.95|1.53||||||Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.53|0.95|
91502979|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.0|1.56||||||Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|1.00|
91502980|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.89|||||TWO_SIDED|95.0|0.74|1.07||||||Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.74|
91502981|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.83|1.26||||||Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.83|
91502982|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.01|1.54||||||Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.54|1.01|
91747460|NCT00673231|183386735|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|3.434||0.0903|TWO_SIDED|95.0|-0.9|12.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.5|-0.9|0.0903
91747461|NCT00673231|183386735|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.7|STANDARD_ERROR_OF_MEAN|3.634||0.0166|TWO_SIDED|95.0|1.6|15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||15.8|1.6|0.0166
91502983|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.33|||||TWO_SIDED|95.0|1.06|1.68||||||Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.06|
91502984|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.25|0.85|
91502985|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.80|
91502986|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.68|||||TWO_SIDED|95.0|1.27|2.22||||||Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.22|1.27|
91502987|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.78|1.2||||||Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.20|0.78|
91502988|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.28|0.84|
91502989|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.22|||||TWO_SIDED|95.0|0.96|1.56||||||Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.96|
91502990|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.88|1.39||||||Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.39|0.88|
91502991|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.17|||||TWO_SIDED|95.0|0.88|1.56||||||Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.88|
91502992|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.17|0.69|
91502993|NCT03760146|182877728|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.30|0.81|
91502994|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|1.01|1.5||||||Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.50|1.01|
91502995|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.16|0.87|
91502996|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.31|||||TWO_SIDED|95.0|2.65|4.13||||||Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.13|2.65|
91502997|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.36|0.91|
91502998|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.84|||||TWO_SIDED|95.0|3.06|4.83||||||Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.83|3.06|
91747462|NCT00673231|183386736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|4.684||0.0008|TWO_SIDED|95.0|-25.0|-6.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-6.6|-25.0|0.0008
91747463|NCT00673231|183386736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|4.616|||TWO_SIDED|95.0|-31.2|-13.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.1|-31.2|
91502999|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.41|||||TWO_SIDED|95.0|2.73|4.26||||||Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.26|2.73|
91503000|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.58|||||TWO_SIDED|95.0|1.3|1.91||||||Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.91|1.30|
91503001|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.5|||||TWO_SIDED|95.0|2.83|4.33||||||Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.33|2.83|
91503002|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.39|||||TWO_SIDED|95.0|1.93|2.96||||||Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.96|1.93|
91503003|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.2|||||TWO_SIDED|95.0|2.53|4.04||||||Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.04|2.53|
91747464|NCT00673231|183386736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_ERROR_OF_MEAN|4.718|<|0.0001|TWO_SIDED|95.0|-34.3|-15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.8|-34.3|<0.0001
91747465|NCT02063867|183386744|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.17
91747466|NCT02063867|183386745|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.16
91503004|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.31|||||TWO_SIDED|95.0|1.91|2.81||||||Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.81|1.91|
91747467|NCT02063867|183386746|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.43
91747468|NCT02063867|183386753|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||<0.001
91503005|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.17|||||TWO_SIDED|95.0|1.76|2.68||||||Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.68|1.76|
91503006|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|4.8|||||TWO_SIDED|95.0|3.65|6.32||||||Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||6.32|3.65|
91503007|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.71|||||TWO_SIDED|95.0|1.38|2.12||||||Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.12|1.38|
91747469|NCT02063867|183386754|SUPERIORITY|||||||0.0126||||||Remains significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0126
91503008|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.62|||||TWO_SIDED|95.0|1.31|2.0||||||Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.00|1.31|
91503009|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.04|1.68||||||Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.04|
91503010|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.51|2.41||||||Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.41|1.51|
91747470|NCT02063867|183386755|SUPERIORITY|||||||0.002||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.002
91747471|NCT02063867|183386756|SUPERIORITY|||||||0.0032||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0032
91747472|NCT04470908|183386759|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.566|||||TWO_SIDED|90.0|0.525|0.61||||||||0.610|0.525|
91747473|NCT04470908|183386760|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.56|||||TWO_SIDED|90.0|0.532|0.589||||||||0.589|0.532|
91747474|NCT04470908|183386761|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.518|||||TWO_SIDED|90.0|0.441|0.608||||||||0.608|0.441|
91747475|NCT02470585|183386780|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.277|0.683||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.683|0.277|<0.001
91747476|NCT02470585|183386781|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.572|||<|0.001|TWO_SIDED|95.0|0.433|0.756||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.756|0.433|<0.001
91747477|NCT02470585|183386782|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.683|||<|0.001|TWO_SIDED|95.0|0.562|0.831||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.831|0.562|<0.001
91747478|NCT02470585|183386783|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.215||||0.335|TWO_SIDED|95.0|0.821|1.799|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.799|0.821|0.335
91747479|NCT02470585|183386784|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.1||||0.462|TWO_SIDED|95.0|0.855|1.414|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.414|0.855|0.462
91747480|NCT02470585|183386785|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.073||||0.45|TWO_SIDED|95.0|0.895|1.287|||Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.287|0.895|0.450
91503011|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.52|||||TWO_SIDED|95.0|1.13|2.05||||||Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.05|1.13|
91747481|NCT02470585|183386786|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.328|TWO_SIDED|95.0|0.567|1.429||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.429|0.567|0.328
91747482|NCT02470585|183386786|SUPERIORITY||Hazard Ratio (HR)|1.218||||0.808|TWO_SIDED|95.0|0.78|1.903||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.903|0.780|0.808
91747483|NCT02470585|183386787|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.116|TWO_SIDED|95.0|0.64|1.114||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.114|0.640|0.116
91747484|NCT02470585|183386787|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.352|TWO_SIDED|95.0|0.726|1.242||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.242|0.726|0.352
91747485|NCT02470585|183386788|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.283|TWO_SIDED|95.0|0.782|1.144||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank|||Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.144|0.782|0.283
91747486|NCT02470585|183386788|SUPERIORITY||Hazard Ratio (HR)|1.034||||0.638|TWO_SIDED|95.0|0.859|1.244||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.244|0.859|0.638
91747487|NCT04283994|183386848|SUPERIORITY||Risk Difference (RD)|0.114||||0.023|TWO_SIDED|95.0|0.03|0.197||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.197|0.030|0.023
91747488|NCT04283994|183386848|SUPERIORITY||Risk Difference (RD)|0.068||||0.294|TWO_SIDED|95.0|-0.013|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.150|-0.013|0.294
91747489|NCT04283994|183386848|SUPERIORITY||Risk Difference (RD)|-0.045||||0.952|TWO_SIDED|95.0|-0.134|0.044||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.044|-0.134|0.952
91531662|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.29||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.29|-12.00|<0.001
91503012|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.69|||||TWO_SIDED|95.0|1.3|2.2||||||Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.20|1.30|
91503013|NCT03760146|182877729|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|1.1|1.79||||||Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.79|1.10|
91503014|NCT00449644|182877739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.77||||0.0034|TWO_SIDED|95.0|2.26|61.23|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||61.23|2.26|0.0034
91503015|NCT00449644|182877740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.57|3.8|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||3.80|1.57|<0.0001
91747490|NCT04283994|183386855|SUPERIORITY||Mean Difference (Final Values)|-0.3||||1.65|TWO_SIDED|95.0|-1.3|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.7|-1.3|1.650
91747491|NCT04283994|183386855|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.985|TWO_SIDED|95.0|-1.6|0.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.5|-1.6|0.985
91747492|NCT04283994|183386855|SUPERIORITY||Mean Difference (Final Values)|0.2||||2.155|TWO_SIDED|95.0|-1.0|1.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.4|-1.0|2.155
91747493|NCT04283994|183386856|SUPERIORITY||Mean Difference (Final Values)|0.7||||2.169|TWO_SIDED|95.0|-3.1|4.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis,|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||4.4|-3.1|2.169
91747494|NCT04283994|183386856|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.391|TWO_SIDED|95.0|-7.5|1.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.0|-7.5|0.391
91747495|NCT04283994|183386856|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.21|TWO_SIDED|95.0|-0.3|8.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||8.2|-0.3|0.210
91747496|NCT04283994|183386857|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.01|TWO_SIDED|95.0|-0.8|2.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.4|-0.8|1.010
91747497|NCT04283994|183386857|SUPERIORITY||Mean Difference (Final Values)|0.0||||2.923|TWO_SIDED|95.0|-1.7|1.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.7|-1.7|2.923
91503016|NCT00449644|182877741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.14||||0.0022|TWO_SIDED|95.0|1.51|6.53|||Cox-proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||6.53|1.51|0.0022
91503017|NCT00449644|182877742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.029|TWO_SIDED|95.0|1.05|2.59|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||MGIT negative (Responders)||2.59|1.05|0.0290
91503018|NCT00449644|182877743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.9|STANDARD_ERROR_OF_MEAN|12.38||0.003|TWO_SIDED|95.0|13.97|63.88|||Regression, Logistic|Treatment as covariate||Week 8||63.88|13.97|0.003
91503019|NCT00449644|182877743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.7|STANDARD_ERROR_OF_MEAN|13.12||0.237|TWO_SIDED|95.0|-10.7|42.17|||Regression, Logistic|Treatment as covariate||Week 24||42.17|-10.70|0.237
91503020|NCT00449644|182877743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.9|STANDARD_ERROR_OF_MEAN|15.02||0.5564|TWO_SIDED|95.0|-21.37|39.18|||Regression, Logistic|Treatment as covariate||Week 104 (Stage 1 Trial End)||39.18|-21.37|0.5564
91503021|NCT00449644|182877744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.008|TWO_SIDED|95.0|5.59|36.83|||Regression, Logistic|Treatment as covariate||Week 24||36.83|5.59|0.008
91503022|NCT00449644|182877744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|STANDARD_ERROR_OF_MEAN|8.27||0.069|TWO_SIDED|95.0|-1.21|31.51|||Regression, Logistic|Treatment as covariate||Week 72||31.51|-1.21|0.069
91503023|NCT00449644|182877744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|8.54||0.035|TWO_SIDED|95.0|1.28|35.08|||Regression, Logistic|Treatment as covariate||Week 120||35.08|1.28|0.035
91503024|NCT00529542|182877745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.58|TWO_SIDED|95.0|-9.3|5.3||All hypotheses tests were two-sided.|Linear mixed-effects models|Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.|This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.|This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.||5.3|-9.3|0.58
91503025|NCT00529542|182877746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.39|TWO_SIDED|95.0|-0.9|2.3|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2.3|-0.9|0.39
91531663|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-9.92|STANDARD_ERROR_OF_MEAN|0.884|<|0.001|TWO_SIDED|95.0|-11.65|-8.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.19|-11.65|<0.001
91531664|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-8.34|STANDARD_ERROR_OF_MEAN|1.086|<|0.001|TWO_SIDED|95.0|-10.47|-6.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.21|-10.47|<0.001
91747498|NCT04283994|183386857|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.034|TWO_SIDED|95.0|-0.9|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.5|-0.9|1.034
91747499|NCT04283994|183386858|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.384|TWO_SIDED|95.0|-1.0|7.9||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||7.9|-1.0|0.384
91503026|NCT00529542|182877747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.8|||<|0.001|TWO_SIDED|95.0|-95.2|-46.4|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-46.4|-95.2|<0.001
91503027|NCT00529542|182877748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.6|||<|0.001|TWO_SIDED|95.0|-79.3|-35.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-35.9|-79.3|<0.001
91503028|NCT00529542|182877749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4||||0.26|TWO_SIDED|95.0|-2.7|9.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||9.5|-2.7|0.26
91503029|NCT00529542|182877750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-82.2|||<|0.001|TWO_SIDED|95.0|-126.2|-38.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-38.1|-126.2|<0.001
91531665|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-9.45|-5.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.21|-9.45|<0.001
91531666|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-5.98|STANDARD_ERROR_OF_MEAN|0.808|<|0.001|TWO_SIDED|95.0|-7.56|-4.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.39|-7.56|<0.001
91531667|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-6.14|-2.27||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.27|-6.14|<0.001
91503030|NCT00529542|182877751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.45|TWO_SIDED|95.0|-12.4|5.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.8|-12.4|0.45
91503031|NCT00529542|182877752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.33|TWO_SIDED|95.0|-2.8|7.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7.9|-2.8|0.33
91503032|NCT00529542|182877753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|586.0||||0.61|TWO_SIDED|95.0|-1811.0|2983.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2983|-1811|0.61
91503033|NCT00529542|182877754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3385.0||||0.07|TWO_SIDED|95.0|-287.0|7056.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7056|-287|0.07
91503034|NCT00529542|182877755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.88|TWO_SIDED|95.0|-24.1|27.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||27.8|-24.1|0.88
91503035|NCT00529542|182877756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-0.5|-1.6|<0.001
91503036|NCT00529542|182877757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-364.3||||0.02|TWO_SIDED|95.0|-655.3|-73.2|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-73.2|-655.3|0.02
91503037|NCT00529542|182877758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.21|TWO_SIDED|95.0|-6.4|1.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.5|-6.4|0.21
91503038|NCT00529542|182877759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9||||0.27|TWO_SIDED|95.0|-16.9|5.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.0|-16.9|0.27
91503039|NCT00529542|182877760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.8||||0.05|TWO_SIDED|95.0|-15.8|0.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||0.1|-15.8|0.05
91503040|NCT00529542|182877761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.5||||0.48|TWO_SIDED|95.0|-6.8|13.7|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||13.7|-6.8|0.48
91503041|NCT00529542|182877762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.63|TWO_SIDED|95.0|-0.6|1.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.0|-0.6|0.63
91503042|NCT01566461|182877763|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||z-test|||||||<0.001
91503043|NCT01566461|182877764|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91503044|NCT01566461|182877765|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91503045|NCT01566461|182877766|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
91503046|NCT01566461|182877767|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91503047|NCT01566461|182877768|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91503048|NCT01566461|182877769|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||t-test, 1 sided|||||||0.859
91503049|NCT01566461|182877770|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
91503050|NCT01566461|182877771|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
91747500|NCT04283994|183386858|SUPERIORITY||Mean Difference (Final Values)|-1.2||||1.923|TWO_SIDED|95.0|-6.1|3.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.7|-6.1|1.923
91503051|NCT01566461|182877772|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91503052|NCT01566461|182877773|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
91503053|NCT01566461|182877774|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
91503054|NCT01566461|182877775|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91503055|NCT01566461|182877776|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||t-test, 1 sided|||||||0.095
91503056|NCT01566461|182877777|SUPERIORITY_OR_OTHER|||||||0.878|TWO_SIDED||||||t-test, 1 sided|||||||0.878
91503057|NCT01566461|182877778|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 1 sided|||||||0.590
91531668|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-4.34|STANDARD_ERROR_OF_MEAN|0.993|<|0.001|TWO_SIDED|95.0|-6.29|-2.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.39|-6.29|<0.001
91503058|NCT01566461|182877779|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
91503059|NCT01566461|182877780|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
91503060|NCT01566461|182877781|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
91503061|NCT01566461|182877782|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 1 sided|||||||0.049
91503062|NCT05778786|182877801|SUPERIORITY|A superiority margin of 0.0 logMAR was used.|Least-Square Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.012|||ONE_SIDED|95.0||-0.1|||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.||-0.10||
91503063|NCT05778786|182877802|SUPERIORITY|A superiority margin of 62 points was used.|Least-quares mean|69.4|STANDARD_ERROR_OF_MEAN|2.13|||ONE_SIDED|95.0|65.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 165 subjects provide at least 99% statistical power to test for superiority.|||65.2|
91503064|NCT05778786|182877803|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.974|STANDARD_DEVIATION|0.01|||TWO_SIDED|95.0|0.95|0.989|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.989|0.950|
91503065|NCT05778786|182877804|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|0.976|0.997|||Bayesian beta-binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.976|
91503066|NCT05778786|182877805|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0053|||TWO_SIDED|95.0|0.977|0.997|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.977|
91503067|NCT05778786|182877806|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Central Posterior Proportion|0.003|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|0.0|0.01|||Bayesian beta-binomial model|Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.01 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible Interval.||0.010|0.000|
91503068|NCT05778786|182877807|SUPERIORITY|A superiority margin of 58 points was used.|Least-squares Mean|66.1|STANDARD_ERROR_OF_MEAN|2.48|||ONE_SIDED|95.0|61.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||61.2|
91503069|NCT05778786|182877808|SUPERIORITY|A superiority margin of 61 points was used.|Least-squares Mean|69.9|STANDARD_ERROR_OF_MEAN|1.66|||ONE_SIDED|95.0|66.6||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||66.6|
91747501|NCT04283994|183386858|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.166|TWO_SIDED|95.0|-0.1|9.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||9.4|-0.1|0.166
91503070|NCT00663052|182877836|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact||Primary endpoint used 95% CI to compare to prespecified target rates for each treatment arm.|With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% \& 68.8%, respectively to reject null hypotheses.||29.88|6.80|0.0015
91503071|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3605|TWO_SIDED|95.0|-3.88|10.16|||Fisher Exact|||Comparison between treatment groups at Week 2||10.16|-3.88|0.3605
91503072|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|17.91||||0.0013|TWO_SIDED|95.0|6.5|29.32|||Fisher Exact|||Comparison between treatment groups at Week 4||29.32|6.50|0.0013
91531669|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-5.27|STANDARD_ERROR_OF_MEAN|1.003|<|0.001|TWO_SIDED|95.0|-7.24|-3.31||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.31|-7.24|<0.001
91503073|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|19.6||||0.0011|TWO_SIDED|95.0|7.51|31.7|||Fisher Exact|||Comparison between treatment groups at Week 8||31.70|7.51|0.0011
91503074|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|20.09|||<|0.0001|TWO_SIDED|95.0|9.77|30.4|||Fisher Exact|||Comparison between treatment groups at Week 12||30.40|9.77|<.0001
91503075|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|14.38||||0.001|TWO_SIDED|95.0|5.39|23.37|||Fisher Exact|||Comparison between treatment groups at Week 16||23.37|5.39|0.0010
91503076|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|10.75||||0.0087|TWO_SIDED|95.0|2.35|19.16|||Fisher Exact|||Comparison between treatment groups at Week 20||19.16|2.35|0.0087
91503077|NCT00663052|182877837|SUPERIORITY_OR_OTHER||Proportion difference|11.46||||0.0068|TWO_SIDED|95.0|2.77|20.15|||Fisher Exact|||Comparison between treatment groups at Week 24||20.15|2.77|0.0068
91503078|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|1.5||||0.2435|TWO_SIDED|95.0|-1.31|4.32|||Fisher Exact|||Comparison between treatment groups at Week 2||4.32|-1.31|0.2435
91531670|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-3.29|STANDARD_ERROR_OF_MEAN|1.222||0.007|TWO_SIDED|95.0|-5.68|-0.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.89|-5.68|0.007
91531671|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-4.61|STANDARD_ERROR_OF_MEAN|1.229|<|0.001|TWO_SIDED|95.0|-7.02|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.20|-7.02|<0.001
91747502|NCT04283994|183386859|SUPERIORITY||Risk Difference (RD)|-0.11||||0.16|TWO_SIDED|95.0|-0.23|0.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.00|-0.23|0.160
91747503|NCT04283994|183386859|SUPERIORITY||Risk Difference (RD)|-0.07||||0.652|TWO_SIDED|95.0|-0.18|0.04||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.04|-0.18|0.652
91747504|NCT04283994|183386859|SUPERIORITY||Risk Difference (RD)|-0.04||||1.39|TWO_SIDED|95.0|-0.16|0.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.07|-0.16|1.390
91747505|NCT04283994|183386860|SUPERIORITY||Risk Difference (RD)|0.05||||1.192|TWO_SIDED|95.0|-0.06|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.06|1.192
91747506|NCT04283994|183386860|SUPERIORITY||Risk Difference (RD)|0.01||||2.698|TWO_SIDED|95.0|-0.11|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.11|2.698
91747507|NCT04283994|183386860|SUPERIORITY||Risk Difference (RD)|0.04||||1.477|TWO_SIDED|95.0|-0.08|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.08|1.477
91747508|NCT04283994|183386861|SUPERIORITY||Mean Difference (Final Values)|-0.57||||2.293|TWO_SIDED|95.0|-4.3|3.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||3.16|-4.30|2.293
91503079|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|1.64||||0.5929|TWO_SIDED|95.0|-4.4|7.67|||Fisher Exact|||Comparison between treatment groups at Week 4||7.67|-4.40|0.5929
91503080|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|13.44||||0.0156|TWO_SIDED|95.0|2.02|24.86|||Fisher Exact|||Comparison between treatment groups at Week 8||24.86|2.02|0.0156
91503081|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|25.18|||<|0.0001|TWO_SIDED|95.0|12.89|37.47|||Fisher Exact|||Comparison between treatment groups at Week 12||37.47|12.89|<.0001
91503082|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|21.84||||0.0003|TWO_SIDED|95.0|9.82|33.85|||Fisher Exact|||Comparison between treatment groups at Week 16||33.85|9.82|0.0003
91503083|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|19.8||||0.0006|TWO_SIDED|95.0|8.23|31.38|||Fisher Exact|||Comparison between treatment groups at Week 20||31.38|8.23|0.0006
91503084|NCT00663052|182877838|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact|||Comparison between treatment groups at Week 24||29.88|6.80|0.0015
91503085|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was not applicable as the percentage of participants achieving 90% improvement in PASI in both treatment groups were 0%.|Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
91503086|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|0.02||||1|TWO_SIDED|95.0|-2.77|2.81|||Fisher Exact|||Comparison between treatment groups at Week 4||2.81|-2.77|1.0000
91503087|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.2611|TWO_SIDED|95.0|-3.2|11.07|||Fisher Exact|||Comparison between treatment groups at Week 8||11.07|-3.20|0.2611
91503088|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|18.37||||0.0002|TWO_SIDED|95.0|8.3|28.45|||Fisher Exact|||Comparison between treatment groups at Week 12||28.45|8.30|0.0002
91503089|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|17.31||||0.0031|TWO_SIDED|95.0|5.43|29.19|||Fisher Exact|||Comparison between treatment groups at Week 16||29.19|5.43|0.0031
91503090|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|15.92||||0.0081|TWO_SIDED|95.0|3.8|28.04|||Fisher Exact|||Comparison between treatment groups at Week 20||28.04|3.80|0.0081
91503091|NCT00663052|182877839|SUPERIORITY_OR_OTHER||Proportion difference|16.78||||0.0064|TWO_SIDED|95.0|4.46|29.1|||Fisher Exact|||Comparison between treatment groups at Week 24||29.10|4.46|0.0064
91747509|NCT04283994|183386861|SUPERIORITY||Mean Difference (Final Values)|-0.48||||2.381|TWO_SIDED|95.0|-4.11|3.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.14|-4.11|2.381
91747510|NCT04283994|183386861|SUPERIORITY||Mean Difference (Final Values)|-0.09||||2.893|TWO_SIDED|95.0|-3.86|3.69||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.69|-3.86|2.893
91747511|NCT04283994|183386862|SUPERIORITY||Risk Difference (RD)|0.0||||2.829|TWO_SIDED|95.0|-0.13|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.13|2.829
91747512|NCT04283994|183386862|SUPERIORITY||Risk Difference (RD)|0.11||||0.188|TWO_SIDED|95.0|-0.01|0.24||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.24|-0.01|0.188
91503092|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was to be calculated by Fisher Exact method but was not estimable as the percentage of participants achieving 100% improvement in PASI in both treatment groups were 0%.||||Comparison between treatment groups at Week 2||0.74|-0.74|
91503093|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
91503094|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|-1.46||||0.4983|TWO_SIDED|95.0|-4.21|1.29|||Fisher Exact|||Comparison between treatment groups at Week 8||1.29|-4.21|0.4983
91503095|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|1.57||||0.4957|TWO_SIDED|95.0|-3.23|6.37|||Fisher Exact|||Comparison between treatment groups at Week 12||6.37|-3.23|0.4957
91503096|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3115|TWO_SIDED|95.0|-3.24|9.52|||Fisher Exact|||Comparison between treatment groups at Week 16||9.52|-3.24|0.3115
91503097|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|6.99||||0.0773|TWO_SIDED|95.0|-1.13|15.1|||Fisher Exact|||Comparison between treatment groups at Week 20||15.10|-1.13|0.0773
91503098|NCT00663052|182877840|SUPERIORITY_OR_OTHER||Proportion difference|5.53||||0.183|TWO_SIDED|95.0|-2.82|13.87|||Fisher Exact|||Comparison between treatment groups at Week 24||13.87|-2.82|0.1830
91503099|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0103|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.3|-2.3|0.0103
91503100|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.8||||0.0031|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.6|-3.0|0.0031
91503101|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.4|-1.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-1.7|-4.4|<0.0001
91503102|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-2.2|-5.0|<0.0001
91503103|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-1.5|-4.0|<0.0001
91503104|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.1||||0.0012|TWO_SIDED|95.0|-3.3|-0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.8|-3.3|0.0012
91747513|NCT04283994|183386862|SUPERIORITY||Risk Difference (RD)|-0.12||||0.19|TWO_SIDED|95.0|-0.24|0.01||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.01|-0.24|0.190
91503105|NCT00663052|182877841|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0042|TWO_SIDED|95.0|-3.4|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.7|-3.4|0.0042
91503106|NCT00663052|182877842|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
91503107|NCT00663052|182877842|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
91503108|NCT00663052|182877842|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.||||0.0053
91503109|NCT00663052|182877842|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.||||0.0432
91503110|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74|||Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
91503111|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
91747514|NCT04283994|183386863|SUPERIORITY||Risk Difference (RD)|0.03||||1.994|TWO_SIDED|95.0|-0.09|0.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.14|-0.09|1.994
91747515|NCT04283994|183386863|SUPERIORITY||Risk Difference (RD)|0.07||||0.771|TWO_SIDED|95.0|-0.05|0.19||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.19|-0.05|0.771
91503112|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|0.04||||1|TWO_SIDED|95.0|-3.58|3.67|||Fisher Exact|||Comparison between treatment groups at Week 8||3.67|-3.58|1.0000
91503113|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.0401|TWO_SIDED|95.0|-0.26|12.47|||Fisher Exact|||Comparison between treatment groups at Week 12||12.47|-0.26|0.0401
91503114|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|3.29||||0.4415|TWO_SIDED|95.0|-4.95|11.54|||Fisher Exact|||Comparison between treatment groups at Week 16||11.54|-4.95|0.4415
91503115|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|8.6||||0.0617|TWO_SIDED|95.0|-0.67|17.87|||Fisher Exact|||Comparison between treatment groups at Week 20||17.87|-0.67|0.0617
91503116|NCT00663052|182877843|SUPERIORITY_OR_OTHER||Proportion difference|8.64||||0.072|TWO_SIDED|95.0|-0.96|18.24|||Fisher Exact|||Comparison between treatment groups at Week 24||18.24|-0.96|0.0720
91503117|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|-1.45||||0.6223|TWO_SIDED|95.0|-5.07|2.16|||Fisher Exact|||Comparison between treatment groups at Week 2||2.16|-5.07|0.6223
91503118|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|6.21||||0.1|TWO_SIDED|95.0|-1.56|13.98|||Fisher Exact|||Comparison between treatment groups at Week 4||13.98|-1.56|0.1000
91503119|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|15.59||||0.0037|TWO_SIDED|95.0|4.53|26.65|||Fisher Exact|||Comparison between treatment groups at Week 8||26.65|4.53|0.0037
91503120|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|22.04||||0.0004|TWO_SIDED|95.0|9.75|34.33|||Fisher Exact|||Comparison between treatment groups at Week 12||34.33|9.75|0.0004
91503121|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|13.46||||0.0285|TWO_SIDED|95.0|0.94|25.97|||Fisher Exact|||Comparison between treatment groups at Week 16||25.97|0.94|0.0285
91503122|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|15.05||||0.0139|TWO_SIDED|95.0|2.67|27.43|||Fisher Exact|||Comparison between treatment groups at Week 20||27.43|2.67|0.0139
91503123|NCT00663052|182877844|SUPERIORITY_OR_OTHER||Proportion difference|19.56||||0.0012|TWO_SIDED|95.0|7.38|31.74|||Fisher Exact|||Comparison between treatment groups at Week 24||31.74|7.38|0.0012
91503124|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|5.01||||0.3956|TWO_SIDED|95.0|-6.01|16.03|||Fisher Exact|||Comparison between treatment groups at Week 2||16.03|-6.01|0.3956
91503125|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|8.66||||0.1754|TWO_SIDED|95.0|-3.82|21.14|||Fisher Exact|||Comparison between treatment groups at Week 4||21.14|-3.82|0.1754
91503126|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|13.81||||0.0207|TWO_SIDED|95.0|1.9|25.72|||Fisher Exact|||Comparison between treatment groups at Week 8||25.72|1.90|0.0207
91503127|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|19.38|||<|0.0001|TWO_SIDED|95.0|9.23|29.53|||Fisher Exact|||Comparison between treatment groups at Week 12||29.53|9.23|<0.0001
91503128|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|13.54||||0.0044|TWO_SIDED|95.0|3.79|23.29|||Fisher Exact|||Comparison between treatment groups at Week 16||23.29|3.79|0.0044
91503129|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|10.62||||0.0223|TWO_SIDED|95.0|1.11|20.13|||Fisher Exact|||Comparison between treatment groups at Week 20||20.13|1.11|0.0223
91503130|NCT00663052|182877845|SUPERIORITY_OR_OTHER||Proportion difference|11.37||||0.0133|TWO_SIDED|95.0|1.96|20.78|||Fisher Exact|||Comparison between treatment groups at Week 24||20.78|1.96|0.0133
91503131|NCT00663052|182877846|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.||||0.0003
91503132|NCT00663052|182877846|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.||||0.0022
91503133|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0193|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.0|-0.3|0.0193
91503134|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0114|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.4|0.0114
91503135|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.5|0.0006
91503136|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.7|<0.0001
91503137|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0058|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.5|0.0058
91503138|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0018|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.1|-0.6|0.0018
91503139|NCT00663052|182877847|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0009|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.2|-0.6|0.0009
91747516|NCT04283994|183386863|SUPERIORITY||Risk Difference (RD)|-0.04||||1.447|TWO_SIDED|95.0|-0.17|0.08||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.08|-0.17|1.447
91747517|NCT04283994|183386866|SUPERIORITY||Risk Difference (RD)|-0.012||||1.836|TWO_SIDED|95.0|-0.058|0.034||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.034|-0.058|1.836
91503140|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.6396|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.6396
91503141|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0074|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0074
91503142|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.9|0.0007
91503143|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.5|-1.1|<0.0001
91503144|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.004|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.8|0.0040
91503145|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.3|-0.9|0.0004
91503146|NCT00663052|182877848|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.1799|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.1|-0.5|0.1799
91503147|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.7757|TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.3|-0.2|0.7757
91503148|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.2112|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||0.1|-0.4|0.2112
91503149|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.5467|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||0.2|-0.3|0.5467
91503150|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.3684|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.1|-0.4|0.3684
91503151|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||-0.2046|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||0.1|-0.4|-0.2046
91503152|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0649|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||0.0|-0.5|0.0649
91503153|NCT00663052|182877849|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8683|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-0.3|0.8683
91503154|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8898|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.8898
91503155|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.009|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0090
91503156|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0028|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.7|0.0028
91503157|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.9|0.0001
91503158|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.3|-0.9|<0.0001
91531672|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|0.974|<|0.001|TWO_SIDED|95.0|-5.35|-1.53||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.53|-5.35|<0.001
91747518|NCT04283994|183386866|SUPERIORITY||Risk Difference (RD)|0.021||||1.25|TWO_SIDED|95.0|-0.03|0.073||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.073|-0.030|1.250
91747519|NCT04283994|183386866|SUPERIORITY||Risk Difference (RD)|-0.033||||0.581|TWO_SIDED|95.0|-0.084|0.017||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.017|-0.084|0.581
91747520|NCT04283994|183386867|SUPERIORITY||Risk Difference (RD)|-0.039||||0.692|TWO_SIDED|95.0|-0.102|0.025||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.025|-0.102|0.692
91503159|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.0016|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-0.8|0.0016
91503160|NCT00663052|182877850|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0602|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-0.6|0.0602
91503161|NCT00663052|182877853|SUPERIORITY_OR_OTHER||Proportion difference|0.42||||1|TWO_SIDED|95.0|-7.7|8.55|||Fisher Exact|||Comparison between treatment groups at Week 12||8.55|-7.70|1.0000
91503162|NCT00663052|182877853|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.4213|TWO_SIDED|95.0|-5.75|13.63|||Fisher Exact|||Comparison between treatment groups at Week 16||13.63|-5.75|0.4213
91503163|NCT00663052|182877853|SUPERIORITY_OR_OTHER||Proportion difference|3.98||||0.4039|TWO_SIDED|95.0|-5.38|13.35|||Fisher Exact|||Comparison between treatment groups at Week 20||13.35|-5.38|0.4039
91503164|NCT00663052|182877853|SUPERIORITY_OR_OTHER||Proportion difference|2.5||||0.6168|TWO_SIDED|95.0|-6.87|11.88|||Fisher Exact|||Comparison between treatment groups at Week 24||11.88|-6.87|0.6168
91503165|NCT00663052|182877854|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.862|TWO_SIDED|95.0|-2.8|2.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||||2.3|-2.8|0.8620
91503166|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|5.68||||0.3525|TWO_SIDED|95.0|-6.05|17.4|||Fisher Exact|||Comparison between treatment groups at Week 2||17.40|-6.05|0.3525
91747521|NCT04283994|183386867|SUPERIORITY||Risk Difference (RD)|0.038||||0.887|TWO_SIDED|95.0|-0.033|0.109||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.109|-0.033|0.887
91503167|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|14.7||||0.0202|TWO_SIDED|95.0|2.19|27.2|||Fisher Exact|||Comparison between treatment groups at Week 4||27.20|2.19|0.0202
91503168|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|14.41||||0.0178|TWO_SIDED|95.0|2.17|26.64|||Fisher Exact|||Comparison between treatment groups at Week 8||26.64|2.17|0.0178
91503169|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|21.52|||<|0.0001|TWO_SIDED|95.0|11.02|32.03|||Fisher Exact|||Comparison between treatment groups at Week 12||32.03|11.02|<0.0001
91747522|NCT04283994|183386867|SUPERIORITY||Risk Difference (RD)|-0.077||||0.08|TWO_SIDED|95.0|-0.145|-0.009||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||-0.009|-0.145|0.080
91503170|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|10.53||||0.0325|TWO_SIDED|95.0|0.43|20.64|||Fisher Exact|||Comparison between treatment groups at Week 16||20.64|0.43|0.0325
91503171|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|12.04||||0.0129|TWO_SIDED|95.0|2.1|21.97|||Fisher Exact|||Comparison between treatment groups at Week 20||21.97|2.10|0.0129
91503172|NCT00663052|182877855|SUPERIORITY_OR_OTHER||Proportion difference|11.28||||0.0209|TWO_SIDED|95.0|1.26|21.3|||Fisher Exact|||Comparison between treatment groups at Week 24||21.30|1.26|0.0209
91503173|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|12.1||||0.0461|TWO_SIDED|95.0|-0.24|24.44|||Fisher Exact|||Comparison between treatment groups at Week 2||24.44|-0.24|0.0461
91503174|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|8.83||||0.1314|TWO_SIDED|95.0|-2.44|20.1|||Fisher Exact|||Comparison between treatment groups at Week 4||20.10|-2.44|0.1314
91503175|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|11.2||||0.0289|TWO_SIDED|95.0|0.65|21.74|||Fisher Exact|||Comparison between treatment groups at Week 8||21.74|0.65|0.0289
91747523|NCT04283994|183386868|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.293|TWO_SIDED|95.0|0.9|2.1||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.1|0.9|0.293
91747524|NCT04283994|183386868|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.027|TWO_SIDED|95.0|1.1|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis|Hazard ratio = clinician-facing intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.5|1.1|0.027
91503176|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|8.52||||0.0433|TWO_SIDED|95.0|-0.04|17.07|||Fisher Exact|||Comparison between treatment groups at Week 12||17.07|-0.04|0.0433
91503177|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|7.06||||0.0902|TWO_SIDED|95.0|-1.32|15.43|||Fisher Exact|||Comparison between treatment groups at Week 16||15.43|-1.32|0.0902
91503178|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|7.79||||0.063|TWO_SIDED|95.0|-0.68|16.26|||Fisher Exact|||Comparison between treatment groups at Week 20||16.26|-0.68|0.0630
91503179|NCT00663052|182877856|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.0907|TWO_SIDED|95.0|-1.53|16.93|||Fisher Exact|||Comparison between treatment groups at Week 24||16.93|-1.53|0.0907
91503180|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|3.25||||0.6255|TWO_SIDED|95.0|-9.39|15.9|||Fisher Exact|||Comparison between treatment groups at Week 2||15.90|-9.39|0.6255
91503181|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|9.3||||0.1292|TWO_SIDED|95.0|-2.85|21.45|||Fisher Exact|||Comparison between treatment groups at Week 4||21.45|-2.85|0.1292
91503182|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|11.86||||0.0251|TWO_SIDED|95.0|0.94|22.78|||Fisher Exact|||Comparison between treatment groups at Week 8||22.78|0.94|0.0251
91503183|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|14.16||||0.0055|TWO_SIDED|95.0|3.68|24.64|||Fisher Exact|||Comparison between treatment groups at Week 12||24.64|3.68|0.0055
91503184|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|11.99||||0.0159|TWO_SIDED|95.0|1.78|22.2|||Fisher Exact|||Comparison between treatment groups at Week 16||22.20|1.78|0.0159
91503185|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|9.05||||0.0672|TWO_SIDED|95.0|-1.08|19.18|||Fisher Exact|||Comparison between treatment groups at Week 20||19.18|-1.08|0.0672
91503186|NCT00663052|182877859|SUPERIORITY_OR_OTHER||Proportion difference|10.51||||0.0351|TWO_SIDED|95.0|0.27|20.75|||Fisher Exact|||Comparison between treatment groups at Week 24||20.75|0.27|0.0351
91503187|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|6.24||||0.2283|TWO_SIDED|95.0|-4.11|16.58|||Fisher Exact|||Comparison between treatment groups at Week 2||16.58|-4.11|0.2283
91503188|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|5.49||||0.2326|TWO_SIDED|95.0|-3.68|14.66|||Fisher Exact|||Comparison between treatment groups at Week 4||14.66|-3.68|0.2326
91503189|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 8||18.52|1.47|0.0165
91503190|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 12||18.52|1.47|0.0165
91747525|NCT04283994|183386868|SUPERIORITY||Hazard Ratio (HR)|0.8||||1.009|TWO_SIDED|95.0|0.6|1.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / clinician-facing intervention. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||1.2|0.6|1.009
91503191|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|4.85||||0.2536|TWO_SIDED|95.0|-3.46|13.15|||Fisher Exact|||Comparison between treatment groups at Week 16||13.15|-3.46|0.2536
91503192|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|5.6||||0.1761|TWO_SIDED|95.0|-2.59|13.78|||Fisher Exact|||Comparison between treatment groups at Week 20||13.78|-2.59|0.1761
91503193|NCT00663052|182877860|SUPERIORITY_OR_OTHER||Proportion difference|4.01||||0.3943|TWO_SIDED|95.0|-5.18|13.2|||Fisher Exact|||Comparison between treatment groups at Week 24||13.20|-5.18|0.3943
91747526|NCT04283994|183386869|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1.366|TWO_SIDED|95.0|-1.55|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.70|-1.55|1.366
91747527|NCT04283994|183386869|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.978|TWO_SIDED|95.0|-1.73|0.58||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.58|-1.73|0.978
91503194|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.5748|TWO_SIDED|95.0|-1.5|0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.8|-1.5|0.5748
91503195|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.2||||0.0471|TWO_SIDED|95.0|-2.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.0|-2.4|0.0471
91503196|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0025|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.7|-3.3|0.0025
91503197|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.2||||0.0009|TWO_SIDED|95.0|-3.5|-0.9|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.9|-3.5|0.0009
91503198|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.9||||0.0015|TWO_SIDED|95.0|-3.1|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.7|-3.1|0.0015
91503199|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.5||||0.0197|TWO_SIDED|95.0|-2.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-2.7|0.0197
91503200|NCT00663052|182877861|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0506|TWO_SIDED|95.0|-2.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-2.6|0.0506
91503201|NCT00663052|182877862|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.04||||0.0435|TWO_SIDED|95.0|0.0|0.09|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.09|0.00|0.0435
91503202|NCT00663052|182877862|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.05||||0.0275|TWO_SIDED|95.0|0.01|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.10|0.01|0.0275
91503203|NCT00663052|182877863|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.9473|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.7|-0.7|0.9473
91503204|NCT00663052|182877863|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.8217|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.6|-0.8|0.8217
91503205|NCT00663052|182877864|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.7||||0.0539|TWO_SIDED|95.0|-1.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.0|-1.4|0.0539
91503206|NCT00663052|182877864|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.5||||0.1494|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-1.3|0.1494
91503207|NCT00663052|182877870|SUPERIORITY_OR_OTHER|||||||0.2139|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2139
91503208|NCT00663052|182877870|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
91747528|NCT04283994|183386869|SUPERIORITY||Mean Difference (Final Values)|0.15||||2.39|TWO_SIDED|95.0|-0.99|1.3||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.30|-0.99|2.390
91747529|NCT04283994|183386870|SUPERIORITY||Mean Difference (Final Values)|0.47||||1.125|TWO_SIDED|95.0|-0.57|1.51||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.51|-0.57|1.125
91747530|NCT04283994|183386870|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.258|TWO_SIDED|95.0|-0.13|1.94||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.94|-0.13|0.258
91503209|NCT00663052|182877872|SUPERIORITY_OR_OTHER|||||||0.2443|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2443
91531673|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.72|-1.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.09|-5.72|0.004
91747531|NCT04283994|183386870|SUPERIORITY||Mean Difference (Final Values)|-0.44||||1.267|TWO_SIDED|95.0|-1.5|0.63||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.63|-1.5|1.267
91747532|NCT04283994|183386871|SUPERIORITY||Mean Difference (Final Values)|0.32||||1.594|TWO_SIDED|95.0|-0.68|1.32||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.32|-0.68|1.594
91503210|NCT00663052|182877872|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
91531674|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|1.18||0.072|TWO_SIDED|95.0|-4.44|0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.19|-4.44|0.072
91503211|NCT00663052|182877873|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 12||||0.0807
91503212|NCT00663052|182877873|SUPERIORITY_OR_OTHER|||||||0.1454|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 24||||0.1454
91503213|NCT01252940|182877887|NON_INFERIORITY_OR_EQUIVALENCE|A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR - SBR) in the response rate was greater than -12%.|Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.1||||||||9.1|-1.6|
91503214|NCT03939897|182877932|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.506|||||||Log Rank|||||||0.5060
91503215|NCT03939897|182877935|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.2989|||||||Log Rank|||||||0.2989
91513363|NCT02753751|182898402|SUPERIORITY|The Mantel-Haenszel test was used, accounting for each hospital as an individual stratum, and to obtain the pooled relative risks across hospitals without adjusting for other baseline factors. (Alert arm is the numerator, control arm is the denominator.) Patients discharged prior to 14 days without an outcome of interest were assumed to be free of that outcome at 14 days. A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Risk Ratio (RR)|1.02||||0.67|TWO_SIDED|95.0|0.93|1.13||A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Cochran-Mantel-Haenszel|||In our retrospective analysis of patients with AKI at 3 potential study hospitals, the composite outcome was 24.5%. A clinically meaningful relative reduction in this risk would be 20%. 5,024 patients (2,512 in each group) would have 90% power to detect a difference in outcome at least this extreme at a two-sided alpha of 0.05 as calculated using the Cochran-Mantel-Haenszel test. We have elected to increase this number by 20% to account for potential contamination.||1.13|0.93|0.67
91513364|NCT02667912|182898411|SUPERIORITY||Mean Difference (Final Values)|10.8||||0.045|TWO_SIDED|95.0|0.3|21.4||The a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||21.4|0.3|0.045
91513365|NCT02667912|182898414|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
91513366|NCT02667912|182898415|OTHER|||||||0.203|||||||t-test, 2 sided|||||||0.203
91513367|NCT02667912|182898416|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.27|TWO_SIDED|95.0|-11.9|3.4|||t-test, 2 sided|||||3.4|-11.9|0.27
91513368|NCT02667912|182898417|SUPERIORITY||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|5.7||0.17|TWO_SIDED|95.0|-3.7|19.3||The a priori threshold for statistical significance p\<0.05|t-test, 2 sided|||||19.3|-3.7|0.17
91531675|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.789|<|0.001|TWO_SIDED|95.0|-6.34|-3.24||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.24|-6.34|<0.001
91747533|NCT04283994|183386871|SUPERIORITY||Mean Difference (Final Values)|0.29||||1.803|TWO_SIDED|95.0|-0.79|1.36||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.36|-0.79|1.803
91747534|NCT04283994|183386871|SUPERIORITY||Mean Difference (Final Values)|0.03||||2.851|TWO_SIDED|95.0|-1.01|1.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.07|-1.01|2.851
91747535|NCT04283994|183386872|SUPERIORITY||Mean Difference (Final Values)|-0.28||||1.243|TWO_SIDED|95.0|-0.97|0.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.40|-0.97|1.243
91747536|NCT04283994|183386872|SUPERIORITY||Mean Difference (Final Values)|-0.33||||1.032|TWO_SIDED|95.0|-1.0|0.35||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.35|-1.00|1.032
91513369|NCT02667912|182898420|SUPERIORITY|||||||0.213|||||||t-test, 2 sided|||||||0.213
91513370|NCT02667912|182898421|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
91513371|NCT02667912|182898422|OTHER|||||||0.304|||||||t-test, 2 sided|||||||0.304
91513372|NCT02667912|182898423|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
91513373|NCT02667912|182898424|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91513374|NCT02667912|182898425|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
91513375|NCT02667912|182898426|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91513376|NCT02667912|182898427|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91513377|NCT02667912|182898428|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
91513378|NCT02667912|182898429|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
91513379|NCT02667912|182898430|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
91513380|NCT02667912|182898431|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||0.217
91513381|NCT02667912|182898432|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||||||0.238
91513382|NCT02667912|182898433|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||||||0.969
91513383|NCT02667912|182898434|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
91513384|NCT01047683|182898441|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.1|||<|0.0001|TWO_SIDED|95.0|-46.6|-21.5||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.01 for the primary endpoint.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A standard deviation of 45% in the TG measurements and a significance level of P \< 0.01 required a sample size of 69 completed patients per treatment group to provide greater than or equal to 90% power to detect a difference of 30% between AMR101 and placebo in the percentage of change from baseline in the fasting TG levels.||-21.5|-46.6|<0.0001
91503216|NCT01925404|182878053|SUPERIORITY|We fitted difference-in-differences (DID) models between the two measurement waves and four study arms. The effect of the intervention was modeled as the wave by study arm interaction. All models used random effects to account for intra-class correlation within each park as well as fixed effects to account for observation times (time of day, weekend versus weekdays).||||||0.0063||||||Significance threshold. p=0.05|negative binomial distribution|||Comparison of change from baseline;||||.0063
91503217|NCT00706641|182878057|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||paired t-test|||Tumor samples from 20 patients were analyzed for expression of pSFK. A paired t-Test was used to calculate the significance of the difference in expression levels before and after treatment.||||0.003
91503218|NCT00706641|182878060|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||paired t-test|||||||0.20
91503219|NCT00706641|182878061|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||paired t-test|||||||0.42
91503220|NCT01327300|182878088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72||||0.001||95.0|||||t-test, 2 sided|||"The GIS scoring system is from 1-7 with one being a worse outcome and 7 the better outcome.~Comparisons below list the p values for comparison of difference in GIS between baseline and mesalamine."||||.001
91531676|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|0.957||0.002|TWO_SIDED|95.0|-4.88|-1.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.13|-4.88|0.002
91531677|NCT02886728|182939612|SUPERIORITY||Least Squares Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-5.65|-1.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.89|-5.65|<0.001
91531678|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|12.8|26.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||26.7|12.8|<0.001
91531679|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|7.6|25.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||25.0|7.6|<0.001
91747537|NCT04283994|183386872|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.742|TWO_SIDED|95.0|-0.7|0.78||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.78|-0.70|2.742
91503221|NCT01327300|182878088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.008||95.0|||||t-test, 2 sided|||Comparisons of mean difference in GIS scores between baseline and placebo is made below.||||0.008
91503222|NCT01327300|182878089|SUPERIORITY_OR_OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||Correlation coefficients were used for each of three biomarkers in relation to other biomarkers and to the questionnaires and patient's symptoms.||||0.873
91531680|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|11.7||||0.004|TWO_SIDED|95.0|3.0|20.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||20.4|3.0|0.004
91531681|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|11.7|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.2|11.7|<0.001
91531682|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|7.1||||0.083|TWO_SIDED|95.0|-1.6|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|-1.6|0.083
91503223|NCT01327300|182878089|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|Pearson's linear coefficient||The study tested three biomarkers and symptom domains at baseline and the end of 12 weeks of placebo using the Mann-Whitney test, as well as correlations between domains with Pearson's linear correlation coefficient.||||0.810
91503224|NCT01327300|182878090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.5||||0.67|||||||t-test, 2 sided|Two-tailed P values are listed for baseline versus 12 weeks of mesalamine||"The FBDSI score is based on the severity of abdominal pian. Severity is rated as the following:~None= 0 points Mild= (1-36) Moderate =(37-110) Severe= (\>110 points)"||||0.67
91503225|NCT01327300|182878090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0||||0.77|||||||t-test, 2 sided|||See prior description of the FBDSI score. Change in the FBDSI after 12 weeks of intervention is made using a two sided t-test.||||0.77
91503226|NCT01327300|182878091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||0.61|||||||t-test, 2 sided|||For the IBS QOL we compared the change in IBS-Quality of Life (IBS-QOL) after 12 weeks of mesalamine.||||0.61
91503227|NCT01327300|182878091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.33|||||||t-test, 2 sided|||Comparison of change in IBS-Quality of Life (IBS-QOL)from baseline after 12 weeks of intervention was made.||||0.33
91503228|NCT01327300|182878092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.71||95.0|||||t-test, 2 sided|||Comparison of the change in HADS score of baseline to 12 weeks of mesalamine is made.||||0.71
91503229|NCT01327300|182878092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.57||95.0|||||t-test, 2 sided|||Comparison of change in HADS score between baseline and after 12 weeks of placebo is made.||||0.57
91747538|NCT04283994|183386873|SUPERIORITY||Mean Difference (Final Values)|-0.02||||2.658|TWO_SIDED|95.0|-0.26|0.22||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.22|-0.26|2.658
91503230|NCT01327300|182878093|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||Comparison of the lactulose/mannitol ratio is made after a 12 week intervention with mesalamine to 12 weeks of placebo.||||0.55
91503231|NCT02603432|182878094|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0005|TWO_SIDED|95.0|0.556|0.863||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model.||||0.863|0.556|0.0005
91503232|NCT02603432|182878117|SUPERIORITY||Cox Proportional Hazard|1.26||||0.913|ONE_SIDED|95.0|0.901||||Log Rank||||||0.901|0.9130
91503233|NCT02666183|182878120|OTHER||Estimated marginal mean difference|-2.251||||0.162|TWO_SIDED|95.0|-5.051|0.55|||ANCOVA|Covariates: DCG age, gender, race, income||||0.550|-5.051|0.162
91503234|NCT02666183|182878120|OTHER||Estimated marginal mean difference|-3.663||||0.007|TWO_SIDED|95.0|-6.538|-0.789|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.789|-6.538|0.007
91503235|NCT02666183|182878120|OTHER||Estimated marginal mean difference|-1.413||||0.714|TWO_SIDED|95.0|-4.29|1.464|||ANCOVA|Covariates: DCG age, gender, race, income||||1.464|-4.290|0.714
91503236|NCT02666183|182878121|OTHER||Estimated marginal mean difference|-0.531||||0.173|TWO_SIDED|95.0|-1.297|0.234|||ANCOVA|Covariates: DCG age, gender, race, income||||0.234|-1.297|0.173
91503237|NCT02666183|182878121|OTHER||Estimated marginal mean difference|-1.456||||0.001|TWO_SIDED|95.0|-2.241|-0.671|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.671|-2.241|0.001
91503238|NCT02666183|182878121|OTHER||Estimated marginal mean difference|-0.925||||0.021|TWO_SIDED|95.0|-1.711|-0.139|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.139|-1.711|0.021
91503239|NCT02666183|182878122|OTHER||Estimated marginal mean difference|-0.984||||0.323|TWO_SIDED|95.0|-2.939|0.971|||ANCOVA|Covariates: DCG age, gender, race, income||||0.971|-2.939|0.323
91503240|NCT02666183|182878122|OTHER||Estimated marginal mean difference|-1.768||||0.086|TWO_SIDED|95.0|-3.785|0.249|||ANCOVA|Covariates: DCG age, gender, race, income||||0.249|-3.785|0.086
91503241|NCT02666183|182878122|OTHER||Estimated marginal mean difference|-0.784||||0.443|TWO_SIDED|95.0|-2.794|1.226|||ANCOVA|Covariates: DCG age, gender, race, income||||1.226|-2.794|0.443
91503242|NCT00666757|182878123|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.||||0.26
91503243|NCT00666757|182878124|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.||||0.07
91503244|NCT00666757|182878125|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.||||0.03
91503245|NCT00666757|182878126|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.09
91503246|NCT00666757|182878127|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.001
91503247|NCT00666757|182878128|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
91503248|NCT00666757|182878129|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.001
91503249|NCT00666757|182878130|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.003
91503250|NCT00666757|182878131|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.01
91503251|NCT00666757|182878132|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.02
91503252|NCT00666757|182878133|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.20
91503253|NCT00666757|182878134|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
91503254|NCT00666757|182878135|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
91503255|NCT00666757|182878136|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
91503256|NCT00666757|182878137|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
91503257|NCT00666757|182878138|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Between group P-value|ANCOVA|||||||0.07
91503258|NCT00666757|182878139|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||Between group P-value|ANCOVA|||||||0.34
91503259|NCT00666757|182878140|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.02
91503260|NCT00666757|182878141|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
91503261|NCT00666757|182878142|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.97
91503262|NCT00666757|182878143|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.32
91503263|NCT00666757|182878144|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Between group P-value|ANCOVA|||Transformed absolute score||||0.12
91503264|NCT00666757|182878145|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Between group P-value|ANCOVA|||Transformed Absolute Score||||0.16
91503265|NCT00666757|182878146|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.002
91531683|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.1|6.4|<0.001
91531684|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|10.6|||<|0.001|TWO_SIDED|95.0|4.4|16.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||16.7|4.4|<0.001
91531685|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|4.7||||0.22|TWO_SIDED|95.0|-3.1|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||12.6|-3.1|0.22
91747539|NCT04283994|183386873|SUPERIORITY||Mean Difference (Final Values)|0.07||||1.523|TWO_SIDED|95.0|-0.14|0.29||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.29|-0.14|1.523
91747540|NCT04283994|183386873|SUPERIORITY||Mean Difference (Final Values)|-0.09||||1.381|TWO_SIDED|95.0|-0.33|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.15|-0.33|1.381
91747541|NCT04283994|183386874|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.191|TWO_SIDED|95.0|-0.18|0.25||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.25|-0.18|2.191
91503266|NCT00666757|182878147|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.53
91531686|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|4.3||||0.25|TWO_SIDED|95.0|-3.6|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||12.1|-3.6|0.25
91531687|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|2.7||||0.35|TWO_SIDED|95.0|-3.5|8.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||8.9|-3.5|0.35
91531688|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|4.6||||0.2|TWO_SIDED|95.0|-2.9|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||12.1|-2.9|0.20
91531689|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|3.1||||0.36|TWO_SIDED|95.0|-4.5|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||10.6|-4.5|0.36
91503267|NCT01231581|182878148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.352|TWO_SIDED|95.0|0.66|1.32|||Log Rank||Hazard ratios are estimated using a Pike estimator.|||1.32|0.66|0.352
91503268|NCT01649375|182878159|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0967|TWO_SIDED|95.0|0.9|3.67|||Regression, Logistic|Missing ASAS responses considered nonresponders||||3.67|0.90|0.0967
91503269|NCT01649375|182878159|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.0001|TWO_SIDED|95.0|2.14|8.96|||Regression, Logistic|Missing ASAS responses considered nonresponders||||8.96|2.14|<.0001
91503270|NCT01649375|182878160|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0194|TWO_SIDED|95.0|1.19|7.48|||Regression, Logistic|Missing ASAS responses considered nonresponders||||7.48|1.19|0.0194
91503271|NCT01649375|182878160|SUPERIORITY||Odds Ratio (OR)|5.07|||<|0.0004|TWO_SIDED|95.0|2.06|12.44|||Regression, Logistic|Missing ASAS responses considered nonresponders||||12.44|2.06|<.0004
91503272|NCT01649375|182878161|SUPERIORITY||Mean Difference (Net)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71|||Mixed Models Analysis|||||0.71|0.41|<0.0001
91503273|NCT01649375|182878161|SUPERIORITY||Mean Difference (Net)|0.49|||<|0.0001|TWO_SIDED|95.0|0.37|0.64|||Mixed Models Analysis|||||0.64|0.37|<0.0001
91503274|NCT01649375|182878162|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0003|TWO_SIDED|95.0|2.31|16.26|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.26|2.31|0.0003
91503275|NCT01649375|182878162|SUPERIORITY||Odds Ratio (OR)|9.15|||<|0.0001|TWO_SIDED|95.0|3.47|24.12|||Regression, Logistic|Missing ASAS responses considered nonresponders||||24.12|3.47|<.0001
91503276|NCT01649375|182878163|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.353|<|0.0001|TWO_SIDED|95.0|-1.77|-0.37|||Mixed Models Analysis|||||-0.37|-1.77|<0.0001
91531690|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|6.3||||0.043|TWO_SIDED|95.0|-0.2|12.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||12.8|-0.2|0.043
91747542|NCT04283994|183386874|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.138|TWO_SIDED|95.0|-0.19|0.27||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.27|-0.19|2.138
91747543|NCT04283994|183386874|SUPERIORITY||Mean Difference (Final Values)|-0.01||||2.879|TWO_SIDED|95.0|-0.23|22.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||022|-0.23|2.879
91747544|NCT03315793|183386875|SUPERIORITY||Least squares mean difference|1.39||||0.5587|TWO_SIDED|98.0|-3.3|6.08|||mixed-effects model repeated measures|||||6.08|-3.30|0.5587
91747545|NCT03315793|183386876|SUPERIORITY||Risk Difference (RD)|5.4||||0.5111|TWO_SIDED|95.0|-10.7|21.5|||Cochran-Mantel-Haenszel|Stratified by age||||21.5|-10.7|0.5111
91503277|NCT01649375|182878163|SUPERIORITY||Mean Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.353||0.0002|TWO_SIDED|95.0|-2.04|-0.65|||Mixed Models Analysis|||||-0.65|-2.04|0.0002
91531691|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|9.4||||0.015|TWO_SIDED|95.0|1.6|17.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||17.2|1.6|0.015
91531692|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|6.5||||0.085|TWO_SIDED|95.0|-1.5|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||14.4|-1.5|0.085
91747546|NCT03315793|183386877|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-13.5|13.5|||Cochran-Mantel-Haenszel|Stratified by age||||13.5|-13.5|1.0000
91747547|NCT03315793|183386878|SUPERIORITY||Risk Difference (RD)|-4.1||||0.4423|TWO_SIDED|95.0|-14.4|6.3|||Cochran-Mantel-Haenszel|Stratified by age||||6.3|-14.4|0.4423
91747548|NCT03315793|183386879|SUPERIORITY||Least squares mean difference|0.14||||0.3836|TWO_SIDED|95.0|-0.18|0.46|||mixed-effects model repeated measures|||||0.46|-0.18|0.3836
91747549|NCT01461928|183386897|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.41|TWO_SIDED|95.0|0.37|1.53||Power at time of final analysis was less than 40%. Final analysis was not able to address its primary objective.|Stratified Long-rank|||The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma). Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.||1.53|0.37|= 0.410
91747550|NCT02447250|183386966|OTHER|||||||0.14|||||||Chi-squared|||comparison of mean birth weights between responders and non-responders||||0.14
91747551|NCT02447250|183386967|OTHER|||||||0.16|||||||Chi-squared|||||||0.16
91747552|NCT02447250|183386968|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91747553|NCT02447250|183386970|OTHER|||||||1|||||||Chi-squared|||||||1.0
91747554|NCT02447250|183386971|OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
91747555|NCT03389555|183386977|EQUIVALENCE|Equivalence margin: if confidence interval for mean difference between SOFA scores at 72 hour time-point for two groups overlaps 0 (p-value \> 0.05) scores considered to be equivalent. Note: The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups, for those patient for whom a SOFA score could be calculated at the 72 hour time point (i.e patients that were alive at the 72 hour time point, 90 patients in the treatment and 88 patients in the control).|Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||A priori threshold for significance, p-value \< 0.05|Mixed Models Analysis|||The primary outcome was analyzed using a linear mixed-effects model where the correlation of within-patient repeated SOFA score measures was accounted for via the use of an unstructured variance-covariance matrix and linear contrasts. Covariates included age, sex, treatment group, time, and the interaction between treatment group and time. Study site was included as a random intercept. The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups.||0.2|-1.7|0.12
91747556|NCT03389555|183386978|EQUIVALENCE|For the key secondary outcome of kidney failure, 200 patients were estimated to provide 94% power, assuming that 30% of participants in the treatment group and 55% in the placebo group would develop kidney failure. If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.58|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of kidney failure in treatment group (intervention versus placebo) controlling for treatment site.||20.0|-10.0|0.58
91747557|NCT03389555|183386979|EQUIVALENCE|If confidence interval for hazard ratio crosses 0, hazard of death assumed to be equivalent in the two groups.|Hazard Ratio (HR)|1.3||||0.05|TWO_SIDED|95.0|0.8|2.2|||Regression, Cox|||Cox Regression controlling for site used to identify hazard ratio for outcome of death for treatment versus intervention group. Null hypothesis is that hazard ratio is 1.||2.2|0.8|0.05
91747558|NCT03389555|183386980|EQUIVALENCE|If the confidence interval for the median difference in ventilator free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|0.0|||>|0.99|TWO_SIDED|95.0|-1.9|1.9|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ventilator free days.||1.9|-1.9|>0.99
91503278|NCT01649375|182878164|SUPERIORITY||Mean Difference (Net)|2.84|STANDARD_ERROR_OF_MEAN|1.108||0.011|TWO_SIDED|95.0|0.66|5.03|||Mixed Models Analysis|||||5.03|0.66|0.0110
91503279|NCT01649375|182878164|SUPERIORITY||Mean Difference (Net)|4.14|STANDARD_ERROR_OF_MEAN|1.105||0.0002|TWO_SIDED|95.0|1.96|6.32|||Mixed Models Analysis|||||6.32|1.96|0.0002
91503280|NCT01649375|182878165|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.748||0.0096|TWO_SIDED|95.0|-3.43|-0.48|||Mixed Models Analysis|||||-0.48|-3.43|0.0096
91503281|NCT01649375|182878165|SUPERIORITY||Mean Difference (Net)|-2.63|STANDARD_ERROR_OF_MEAN|0.743||0.0005|TWO_SIDED|95.0|-4.09|-1.16|||Mixed Models Analysis|||||-1.16|-4.09|0.0005
91503282|NCT01649375|182878166|SUPERIORITY||Odds Ratio (OR)|4.28||||0.0325|TWO_SIDED|95.0|1.13|16.21|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.21|1.13|0.0325
91503283|NCT01649375|182878166|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0471|TWO_SIDED|95.0|1.02|15.01|||Regression, Logistic|Missing ASAS responses considered nonresponders||||15.01|1.02|0.0471
91503284|NCT01856790|182878167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.05
91503285|NCT01856790|182878168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.002
91503286|NCT01856790|182878170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.97
91503287|NCT01856790|182878174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon Matched Pairs signed rank tests|||||||.001
91503288|NCT01856790|182878175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.005
91503289|NCT04091646|182878181|SUPERIORITY||Odds Ratio (OR)|4.95|||<|0.0001|TWO_SIDED|95.0|2.51|9.76|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||9.76|2.51|<0.0001
91531693|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|9.9||||0.002|TWO_SIDED|95.0|3.2|16.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||16.6|3.2|0.002
91531694|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|10.5||||0.01|TWO_SIDED|95.0|2.3|18.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.7|2.3|0.010
91747559|NCT03389555|183386981|EQUIVALENCE|If the confidence interval for the median difference in shock free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.02|TWO_SIDED|95.0|0.2|1.8|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's shock free days.||1.8|0.2|0.02
91747560|NCT03389555|183386982|EQUIVALENCE|If the confidence interval for the median difference in ICU free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.69|TWO_SIDED|95.0|-3.0|6.0|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ICU free days.||6.0|-3.0|0.69
91747561|NCT03389555|183386983|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.55|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of hospital mortality in treatment group (intervention versus placebo) controlling for treatment site..||20.0|-10.0|0.55
91503290|NCT04091646|182878182|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0033|TWO_SIDED|95.0|1.46|7.52|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 2 Odds Ratio||7.52|1.46|0.0033
91503291|NCT04091646|182878182|SUPERIORITY||Odds Ratio (OR)|3.78||||0.0002|TWO_SIDED|95.0|1.94|7.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 4 Odds Ratio||7.38|1.94|0.0002
91503292|NCT04091646|182878183|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Erythema Score||||<0.0001
91503293|NCT04091646|182878183|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Erythema Score||||<0.0001
91503294|NCT04091646|182878183|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Erythema Score||||<0.0001
91503295|NCT04091646|182878184|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0065|TWO_SIDED|95.0|1.49|17.13|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 2||17.13|1.49|0.0065
91503296|NCT04091646|182878184|SUPERIORITY||Odds Ratio (OR)|5.36||||0.0002|TWO_SIDED|95.0|2.15|13.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 4||13.38|2.15|0.0002
91503297|NCT04091646|182878184|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0021|TWO_SIDED|95.0|1.5|6.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 8||6.63|1.50|0.0021
91503298|NCT04091646|182878185|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Scaling Score||||<0.0001
91503299|NCT04091646|182878185|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Scaling Score||||<0.0001
91503300|NCT04091646|182878185|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Scaling Score||||<0.0001
91503301|NCT04091646|182878186|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0759|TWO_SIDED|95.0|0.9|4.33|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 2||4.33|0.90|0.0759
91503302|NCT04091646|182878186|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0122|TWO_SIDED|95.0|1.18|4.61|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 4||4.61|1.18|0.0122
91503303|NCT04091646|182878186|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0003|TWO_SIDED|95.0|1.74|6.55|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 8||6.55|1.74|0.0003
91503304|NCT04091646|182878188|SUPERIORITY||Odds Ratio (OR)|3.62||||0.0007|TWO_SIDED|95.0|1.72|7.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 2||7.63|1.72|0.0007
91503305|NCT04091646|182878188|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0009|TWO_SIDED|95.0|1.63|6.68|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 4||6.68|1.63|0.0009
91503306|NCT04091646|182878188|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0007|TWO_SIDED|95.0|1.6|6.35|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 8||6.35|1.60|0.0007
91503307|NCT01921829|182878189|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91503308|NCT01921829|182878190|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
91503309|NCT01921829|182878192|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
91503310|NCT01921829|182878193|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
91503311|NCT01921829|182878194|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
91503312|NCT01921829|182878195|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
91531695|NCT02886728|182939613|SUPERIORITY||Difference in Response Rates|9.6||||0.014|TWO_SIDED|95.0|1.4|17.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||17.8|1.4|0.014
91747562|NCT03389555|183386984|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|2.0||||0.8|TWO_SIDED|95.0|-10.0|10.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of ICU mortality in treatment group (intervention versus placebo) controlling for treatment site.||10.0|-10.0|0.80
91747563|NCT03389555|183386985|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-12.0||||0.16|TWO_SIDED|95.0|-25.0|4.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of occurrence of delirium in treatment group (intervention versus placebo) controlling for treatment site.||4|-25|0.16
91747564|NCT03389555|183386986|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-1.8||||0.82|TWO_SIDED|95.0|-18.0|14.0|||Regression, Logistic|||Logistic regression analysis evaluating home hospital disposition in survivors to hospital discharge in intervention versus placebo group controlling for treatment site.||14|-18|0.82
91503313|NCT01921829|182878196|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
91503314|NCT01921829|182878197|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91503315|NCT01921829|182878198|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
91503316|NCT01921829|182878199|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
91503317|NCT01921829|182878200|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
91503318|NCT01921829|182878201|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
91503319|NCT01921829|182878202|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
91503320|NCT01921829|182878203|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91503321|NCT01921829|182878204|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91503322|NCT01921829|182878205|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
91503323|NCT01921829|182878206|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
91503324|NCT01921829|182878207|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91503325|NCT01921829|182878208|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
91503326|NCT01921829|182878209|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
91503327|NCT05394025|182878215|SUPERIORITY||Interaction|0.02||||0.77|TWO_SIDED|95.0|-0.13|0.18|||likelihood ratio test||Beta for time by COVID-19 status|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.18|-0.13|0.77
91503328|NCT05394025|182878215|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6|TWO_SIDED|95.0|-0.44|0.67|||likelihood ratio test||Beta coefficient for mean difference in mean longitudinal I/ADL score|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model I/ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.67|-0.44|0.60
91503329|NCT03538158|182878268|SUPERIORITY||Slope|5.7||||0.82|TWO_SIDED|95.0|-287.7|299.1|||Mixed Models Analysis|F(2,131)=.07||||299.1|-287.7|.82
91503330|NCT03538158|182878269|SUPERIORITY||Slope|0.5||||0.97|TWO_SIDED|95.0|-3.5|4.4|||Mixed Models Analysis|F(2,75)=.03||||4.4|-3.5|.97
91513385|NCT01047683|182898441|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.7||||0.0051|TWO_SIDED|95.0|-33.3|-5.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-5.6|-33.3|0.0051
91513386|NCT01047683|182898442|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.6||||0.0005|TWO_SIDED|95.0|-43.4|-13.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05 for secondary and exploratory endpoints.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-13.9|-43.4|0.0005
91503331|NCT02876900|182878283|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.634||0.003|TWO_SIDED|95.0|-8.06|-1.64||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-1.64|-8.06|0.003
91503332|NCT02876900|182878283|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-9.81|-3.4||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-3.4|-9.81|<0.001
91503333|NCT02876900|182878284|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.16|-0.55|<0.001
91503334|NCT02876900|182878284|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.25|-0.64|<0.001
91503335|NCT00791518|182878309|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||||95.0|0.1|0.4|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and are adjusted for Investigator.|||0.4|0.1|
91503336|NCT00791518|182878310|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||||95.0|0.2|0.4|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||0.4|0.2|
91503337|NCT00791518|182878315|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||||95.0|-0.4|1.7|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and was adjusted for Investigator.|||1.7|-0.4|
91503338|NCT00791518|182878316|SUPERIORITY_OR_OTHER||Least squares mean difference|0.9||||||95.0|-0.2|2.1|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||2.1|-0.2|
91503339|NCT00720057|182878319|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.||||<0.001
91503340|NCT00720057|182878320|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91503341|NCT00720057|182878321|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91503342|NCT00720057|182878322|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.||||<0.001
91531696|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
91503343|NCT00720057|182878323|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91747565|NCT01885208|183386987|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
91747566|NCT01885208|183386987|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
91747567|NCT00920218|183387008|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|32.31|||<|0.0001|TWO_SIDED|76.16|20.65|50.54|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (\<) 1.||50.54|20.65|<0.0001
91503344|NCT00720057|182878324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
91503345|NCT03341533|182878355|EQUIVALENCE|The null hypothesis is that there is no difference in NPIS between the two groups.|difference in medians|0.0||||0.39|TWO_SIDED||||||Kruskal-Wallis|||||||0.39
91503346|NCT03341533|182878356|EQUIVALENCE|The null hypothesis is that there is no difference in MME use on the hospital floor between groups.|Difference of medians|-4.5||||0.88|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual care|||||0.88
91503347|NCT03341533|182878357|EQUIVALENCE|The null hypothesis is that the outpatient MME consumption will be the same across the two groups.|difference in medians|-7.5||||0.75|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual Care|||||0.75
91503348|NCT03341533|182878358|EQUIVALENCE|The null hypothesis is that the postoperative BPI pain severity score will be the same between groups|difference in medians|-0.3||||0.8|TWO_SIDED||||||Kruskal-Wallis||Ice Packs - Usual Care|||||0.80
91503349|NCT03642717|182878411|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Glycosylated hemoglobin (HbA1c) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
91503350|NCT03642717|182878414|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Fasting Plasma Glucose (FPG) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
91503351|NCT03642717|182878415|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in body weight at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
91503352|NCT03642717|182878416|OTHER|||||||0.0076||||||Paired t-test was applied comparing the difference in mean of change in systolic blood pressure (SBP) at Last Visit versus at Baseline.|Paired t-test|||||||0.0076
91503353|NCT03642717|182878417|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in diastolic blood pressure (DBP) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
91503354|NCT02587065|182878419|OTHER||Spearman's correlation coefficient|-0.85||||0.56|TWO_SIDED|95.0|-3.72|2.02|||Mixed-effects REML regression|||Adjusted change of convenience satisfaction domain of TSQM-9.||2.02|-3.72|0.56
91503355|NCT01559012|182878430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_DEVIATION|2.7||0.001|TWO_SIDED|95.0|1.05|3.32||A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01 and a beta \> 0.90.|Wilcoxon (Mann-Whitney)|Statistical signiﬁcance was assessed by the use of Mann-Whitney U test. P \< 0.05 was deﬁned as statistically signiﬁcant||This is an analysis between groups of intervention clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||3.32|1.05|0.001
91503356|NCT01559012|182878430|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|1.83|||<|0.02|TWO_SIDED|95.0|0.43|3.24|||Wilcoxon (Mann-Whitney)|||This is a within patient variation between clonidine and placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean +/- Standard Deviation (SD).||3.24|0.43|<0.02
91747568|NCT00920218|183387008|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|9.51|||<|0.0001|TWO_SIDED|76.16|6.07|14.9|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group \< 2.||14.9|6.07|<0.0001
91747569|NCT00920218|183387009|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|74.41|||<|0.0001|TWO_SIDED|76.16|33.12|167.17|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group \< 1.||167.17|33.12|<0.0001
91747570|NCT00920218|183387009|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|42.2|||<|0.0001|TWO_SIDED|76.16|20.2|88.13|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group \< 1.||88.13|20.20|<0.0001
91747571|NCT01709422|183387022|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.05||95.0|||||Chi-squared|||||||0.05
91747572|NCT01709422|183387023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
91747573|NCT01074463|183387076|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|109.18|||||TWO_SIDED|90.0|99.25|120.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120.12|99.25|
91747574|NCT01074463|183387077|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.06|||||TWO_SIDED|90.0|98.73|109.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.68|98.73|
91747575|NCT01074463|183387078|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.34|||||TWO_SIDED|90.0|97.78|107.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.11|97.78|
91747576|NCT02449889|183387079|NON_INFERIORITY|Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) \> -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.8|-0.6|
91747577|NCT02449889|183387079|NON_INFERIORITY|As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.5|2.0|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||2.0|-0.5|
91747578|NCT02449889|183387080|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.6|1.5|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.5|-0.6|
91747579|NCT02449889|183387080|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||1.6|-0.4|
91503357|NCT01559012|182878431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.009|TWO_SIDED|95.0|1.78|11.5|||Wilcoxon (Mann-Whitney)|||Analysis within groups clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||11.5|1.78|0.009
91503358|NCT01559012|182878431|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|7.5|||<|0.01|TWO_SIDED|95.0|2.17|12.83|||Wilcoxon (Mann-Whitney)|||Analysis within-patient. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||12.83|2.17|<0.01
91503359|NCT01559012|182878432|SUPERIORITY_OR_OTHER||difference of percentage of positivity|0.3||||0|TWO_SIDED|95.0|0.04|0.47|||Wilcoxon (Mann-Whitney)|||"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"||0.47|0.04|0.000
91503360|NCT01559012|182878433|SUPERIORITY_OR_OTHER||mean values|0.8||||0.013|TWO_SIDED|95.0|0.13|1.57|||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||1.57|0.13|0.013
91503361|NCT01559012|182878434|SUPERIORITY_OR_OTHER||days off-therapy %|29.0||||0.051|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||||0.051
91503362|NCT01559012|182878435|SUPERIORITY_OR_OTHER||proportion|0.0||||0.0089|TWO_SIDED|95.0|||||Fisher Exact|||||||0.0089
91503363|NCT01559012|182878438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.01|TWO_SIDED|95.0|0.9|10.9|||Wilcoxon (Mann-Whitney)|||||10.9|0.9|0.01
91503364|NCT01559012|182878439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.055|TWO_SIDED|95.0|0.3|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|0.3|0.055
91503365|NCT00946712|182878441|OTHER||Hazard Ratio (HR)|0.93||||0.22|TWO_SIDED|95.0|0.83|1.04|||Log Rank|A stratified log rank test was used.||||1.04|0.83|0.22
91503366|NCT00946712|182878442|OTHER||Hazard Ratio (HR)|0.92||||0.4|TWO_SIDED|95.0|0.75|1.12|||Log Rank|A stratified log rank test was used.||||1.12|0.75|0.40
91503367|NCT00946712|182878443|OTHER||Hazard Ratio (HR)|0.81||||0.054|TWO_SIDED|95.0|0.66|1.0|||Log Rank|A stratified log rank test was used.||||1.00|0.66|0.054
91747580|NCT02449889|183387081|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.6|1.3|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC||1.3|-0.6|
91503368|NCT00946712|182878445|OTHER||Hazard Ratio (HR)|0.99||||0.83|TWO_SIDED|95.0|0.88|1.1|||Log Rank|A stratified log rank test was used.||||1.10|0.88|0.83
91503369|NCT00946712|182878447|OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.48
91503370|NCT00946712|182878448|OTHER|||||||0.06|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.060
91503371|NCT04665050|182878450|OTHER|Estimated difference and confidence interval (CI) are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Injection Site Erythema||12.7|-12.7|
91503372|NCT04665050|182878450|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-11.8|||||TWO_SIDED|95.0|-30.0|7.3|||||V116 minus PNEUMOVAX™23|Injection Site Pain||7.3|-30.0|
91503373|NCT04665050|182878450|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||V116 minus PNEUMOVAX™23|Injection Site Swelling||14.1|-14.1|
91747581|NCT02449889|183387081|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.||1.4|-0.5|
91503374|NCT04665050|182878451|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|3.9|||||TWO_SIDED|95.0|-9.4|17.5|||||V116 minus PNEUMOVAX™23|Fatigue||17.5|-9.4|
91503375|NCT04665050|182878451|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.9|9.9|||||V116 minus PNEUMOVAX™23|Arthralgia||9.9|-9.9|
91503376|NCT04665050|182878451|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-2.0|||||TWO_SIDED|95.0|-17.5|13.6|||||V116 minus PNEUMOVAX™23|Myalgia||13.6|-17.5|
91503377|NCT04665050|182878451|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Headache||12.7|-12.7|
91503378|NCT04665050|182878452|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||V116 minus PNEUMOVAX™23|||7.1|-7.1|
91503379|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.07|2.4|||||V116/PNEUMOVAX™23|Serotype 3||2.40|1.07|
91503380|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.11|||||V116/PNEUMOVAX™23|Serotype 7F||2.11|0.69|
91503381|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.24|3.24|||||V116/PNEUMOVAX™23|Serotype 19A||3.24|1.24|
91503382|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.92|||||TWO_SIDED|95.0|1.04|3.57|||||V116/PNEUMOVAX™23|Serotype 22F||3.57|1.04|
91503383|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.71|1.86|||||V116/PNEUMOVAX™23|Serotype 33F||1.86|0.71|
91503384|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.78|||||TWO_SIDED|95.0|1.24|2.58|||||V116/PNEUMOVAX™23|Serotype 8||2.58|1.24|
91503385|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|1.19|3.0|||||V116/PNEUMOVAX™23|Serotype 9N||3.00|1.19|
91503386|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.71|||||TWO_SIDED|95.0|1.47|5.0|||||V116/PNEUMOVAX™23|Serotype 10A||5.00|1.47|
91503387|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.43|||||TWO_SIDED|95.0|1.52|3.89|||||V116/PNEUMOVAX™23|Serotype 11A||3.89|1.52|
91503388|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.2|4.83|||||V116/PNEUMOVAX™23|Serotype 12F||4.83|1.20|
91503389|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.57|||||TWO_SIDED|95.0|1.59|4.17|||||V116/PNEUMOVAX™23|Serotype 17F||4.17|1.59|
91503390|NCT04665050|182878453|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.28|||||TWO_SIDED|95.0|1.46|3.56|||||V116/PNEUMOVAX™23|Serotype 20A||3.56|1.46|
91503391|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.54|||||TWO_SIDED|95.0|1.08|2.21|||||V116/PNEUMOVAX™23|Serotype 3||2.21|1.08|
91747582|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.72|1.05||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.||1.05|0.72|
91747583|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.||1.26|0.84|
91747584|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.||1.10|0.74|
91503392|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.21|||||TWO_SIDED|95.0|1.36|3.6|||||V116/PNEUMOVAX™23|Serotype 7F||3.60|1.36|
91503393|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.45|3.23|||||V116/PNEUMOVAX™23|Serotype 19A||3.23|1.45|
91503394|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.33|||||TWO_SIDED|95.0|1.36|3.99|||||V116/PNEUMOVAX™23|Serotype 22F||3.99|1.36|
91503395|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.52|||||TWO_SIDED|95.0|0.97|2.37|||||V116/PNEUMOVAX™23|Serotype 33F||2.37|0.97|
91503396|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.88|||||TWO_SIDED|95.0|1.32|2.68|||||V116/PNEUMOVAX™23|Serotype 8||2.68|1.32|
91503397|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.37|||||TWO_SIDED|95.0|1.49|3.74|||||V116/PNEUMOVAX™23|Serotype 9N||3.74|1.49|
91503398|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.28|3.65|||||V116/PNEUMOVAX™23|Serotype 10A||3.65|1.28|
91503399|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.28|2.89|||||V116/PNEUMOVAX™23|Serotype 11A||2.89|1.28|
91503400|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.49|||||TWO_SIDED|95.0|1.94|6.27|||||V116/PNEUMOVAX™23|Serotype 12F||6.27|1.94|
91503401|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.88|||||TWO_SIDED|95.0|1.92|4.31|||||V116/PNEUMOVAX™23|Serotype 17F||4.31|1.92|
91503402|NCT04665050|182878454|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.05|||||TWO_SIDED|95.0|1.3|3.25|||||V116/PNEUMOVAX™23|Serotype 20A||3.25|1.30|
91503403|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.58|||||TWO_SIDED|95.0|1.86|6.88|||||V116/PNEUMOVAX™23|Serotype 6A||6.88|1.86|
91503404|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|6.23|||||TWO_SIDED|95.0|3.54|10.98|||||V116/PNEUMOVAX™23|Serotype 15A||10.98|3.54|
91503405|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|2.33|||||TWO_SIDED|95.0|1.23|4.39|||||V116/PNEUMOVAX™23|Serotype 15C||4.39|1.23|
91503406|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|10.06|||||TWO_SIDED|95.0|5.39|18.78|||||V116/PNEUMOVAX™23|Serotype 16F||18.78|5.39|
91503407|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|42.09|||||TWO_SIDED|95.0|19.67|90.03|||||V116/PNEUMOVAX™23|Serotype 23A||90.03|19.67|
91503408|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.37|||||TWO_SIDED|95.0|6.97|21.94|||||V116/PNEUMOVAX™23|Serotype 23B||21.94|6.97|
91503409|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|24.82|||||TWO_SIDED|95.0|11.65|52.86|||||V116/PNEUMOVAX™23|Serotype 24F||52.86|11.65|
91503410|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|25.66|||||TWO_SIDED|95.0|14.65|44.93|||||V116/PNEUMOVAX™23|Serotype 31||44.93|14.65|
91503411|NCT04665050|182878455|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|14.3|||||TWO_SIDED|95.0|8.72|23.47|||||V116/PNEUMOVAX™23|Serotype 35B||23.47|8.72|
91503412|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.0|||||TWO_SIDED|95.0|1.73|5.19|||||V116/PNEUMOVAX™23|Serotype 6A||5.19|1.73|
91747585|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.||1.07|0.66|
91503413|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.03|||||TWO_SIDED|95.0|4.61|13.98|||||V116/PNEUMOVAX™23|Serotype 15A||13.98|4.61|
91503414|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.14|||||TWO_SIDED|95.0|1.77|5.58|||||V116/PNEUMOVAX™23|Serotype 15C||5.58|1.77|
91503415|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|13.06|||||TWO_SIDED|95.0|8.45|20.19|||||V116/PNEUMOVAX™23|Serotype 16F||20.19|8.45|
91503416|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.55|||||TWO_SIDED|95.0|5.19|14.09|||||V116/PNEUMOVAX™23|Serotype 23A||14.09|5.19|
91503417|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|4.15|||||TWO_SIDED|95.0|2.72|6.36|||||V116/PNEUMOVAX™23|Serotype 23B||6.36|2.72|
91503418|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|28.68|||||TWO_SIDED|95.0|16.59|49.58|||||V116/PNEUMOVAX™23|Serotype 24F||49.58|16.59|
91503419|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.27|||||TWO_SIDED|95.0|6.71|15.73|||||V116/PNEUMOVAX™23|Serotype 31||15.73|6.71|
91503420|NCT04665050|182878456|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|15.95|||||TWO_SIDED|95.0|11.62|21.9|||||V116/PNEUMOVAX™23|Serotype 35B||21.90|11.62|
91747586|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.84|1.2||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.||1.20|0.84|
91747587|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.||1.14|0.78|
91503421|NCT00853723|182878459|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline by day 15 in all three arms.|Kruskal-Wallis|||||||<0.0005
91503422|NCT00853723|182878460|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups.|Kruskal-Wallis|The threshold for stasistical significance was p=0.05||||||<0.05
91503423|NCT00853723|182878461|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline at Day 60 and at Day 90 for the PTH group and at day 90 for the PTHrP 400 and PTHrP 600 groups .|Kruskal-Wallis|||||||<0.05
91503424|NCT00853723|182878462|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in PTHrP 400 and 600 groups.|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
91503425|NCT00853723|182878463|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in the PTHrP 400 group|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
91513387|NCT01047683|182898442|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.3||||0.1152|TWO_SIDED|95.0|-30.3|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-30.3|0.1152
91513388|NCT01047683|182898443|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0006|TWO_SIDED|95.0|-20.2|-6.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.3|-20.2|0.0006
91503426|NCT00853723|182878464|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical signifcance was p=0.05||||||>0.05
91503427|NCT00853723|182878465|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||>0.05
91503428|NCT00853723|182878466|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds to change from baseline at Day 15 and 30 in the PTHrP 400 group and at Day 15 in the PTHrP 600 group|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.0005
91503429|NCT00853723|182878467|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to PTH group on Day 60 compared to the PTHrP 400|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.05
91503430|NCT00853723|182878467|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the PTH group on Day 30 compared to the PTHrP 400 group and Day 60 compared to the PTHRp 600 group|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
91503431|NCT00853723|182878467|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value correspond to the PTH group on Day 15 compared to the PTHrP 400 group and Day 15 and 30 compared to the PTHrP 600 group.|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.0005
91503432|NCT00853723|182878468|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the increase from baseline to D90 in the PTHrP 400 group.|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.005
91503433|NCT00853723|182878469|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p value corresponds to an increased from baseline at all time points in all Arms/groups as well as to the increase in the in the PTHrP 400 group at Day 60 and 90 compared to the PTHrP 600 and PTH groups .|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.05
91531697|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
91531698|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
91531699|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
91531700|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
91503434|NCT00853723|182878469|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the comparison of the PTHrP 400 group at Day 15 to the PTHrP 600 and PTH groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
91503435|NCT00853723|182878470|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to an increase compared to baseline in the PTHrP 600 group at D15 and D30|F-test, one way analysis of variance|The threshold for stastistical significance was p=0.05||||||<0.05
91503436|NCT00853723|182878470|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.005|TWO_SIDED|||||the reported p-value corresponds to change from baseline in the PTHrP 400 group at Day 15,30, 60 and 90 and the PTH group at day 90.|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.005
91503437|NCT00853723|182878471|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds the PTH group on Day 15 compared to the PTHrP 400 group and to the PTHrP 600 group at Day 30 and Day 60|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.05
91503438|NCT00853723|182878471|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.0005|TWO_SIDED|||||Thre reported p-value correspond to the PTH group compared to the PTHrp 600 group at day 15|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.0005
91503439|NCT01787175|182878497|SUPERIORITY_OR_OTHER||Difference in time to complete A&P|-17.73||||0.047|TWO_SIDED|95.0|-35.24|-0.23|||Mixed-effects linear model|||Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||-0.23|-35.24|0.047
91503440|NCT01787175|182878498|SUPERIORITY_OR_OTHER||Value of problem scores for A&P complete|0.04||||0.15|TWO_SIDED|95.0|-0.01|0.09|||Mixed-effects linear model|||Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||0.09|-0.01|0.15
91747588|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.78|1.23||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.||1.23|0.78|
91503441|NCT01787175|182878499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.005|TWO_SIDED|95.0|1.22|2.98|||Regression, Logistic|||Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||2.98|1.22|0.005
91503442|NCT02867709|182878500|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0285|TWO_SIDED|95.0|1.09|2.22||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.22|1.09|0.0285
91503443|NCT02867709|182878500|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0129|TWO_SIDED|95.0|1.14|2.29||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.29|1.14|0.0129
91747589|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.52|||||TWO_SIDED|95.0|0.41|0.67||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.||0.67|0.41|
91503444|NCT02867709|182878501|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0711|TWO_SIDED|95.0|1.02|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||1.83|1.02|0.0711
91503445|NCT02867709|182878501|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0129|TWO_SIDED|95.0|1.25|2.2||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.20|1.25|0.0129
91503446|NCT02867709|182878502|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0711|TWO_SIDED|95.0|1.25|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.17|1.25|0.0711
91503447|NCT02867709|182878502|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0129|TWO_SIDED|95.0|1.35|2.32||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.32|1.35|0.0129
91503448|NCT02867709|182878503|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0711|TWO_SIDED|95.0|1.33|2.48||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.48|1.33|0.0711
91503449|NCT02867709|182878503|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0129|TWO_SIDED|95.0|1.59|2.92||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.92|1.59|0.0129
91503450|NCT02867709|182878504|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0711|TWO_SIDED|95.0|1.04|2.53||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.53|1.04|0.0711
91503451|NCT02867709|182878504|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0129|TWO_SIDED|95.0|1.2|2.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.83|1.20|0.0129
91747590|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.86|||||TWO_SIDED|95.0|0.68|1.08||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.||1.08|0.68|
91503452|NCT02867709|182878505|SUPERIORITY||Odds Ratio (OR)|1.28||||0.1833|TWO_SIDED|95.0|0.96|1.72||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||1.72|0.96|0.1833
91503453|NCT02867709|182878505|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0167|TWO_SIDED|95.0|1.14|2.02||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.02|1.14|0.0167
91747591|NCT00758264|183387086|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.||1.38|0.83|
91503454|NCT02867709|182878506|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|1.04|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.83|1.04|0.1066
91503455|NCT02867709|182878506|SUPERIORITY||Odds Ratio (OR)|1.39||||0.044|TWO_SIDED|95.0|1.05|1.84||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.84|1.05|0.0440
91503456|NCT02867709|182878507|SUPERIORITY||Odds Ratio (OR)|1.1||||0.9522|TWO_SIDED|95.0|0.81|1.49||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.49|0.81|0.9522
91503457|NCT02867709|182878507|SUPERIORITY||Odds Ratio (OR)|1.12||||0.9522|TWO_SIDED|95.0|0.83|1.51||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.51|0.83|0.9522
91503458|NCT03971695|182878524|OTHER||Adjusted geometric mean (gMean) ratio(%)|100.26|||||TWO_SIDED|90.0|90.18|111.48|||||Intra-individual geometric coefficient of variance (gCV) = 14.2. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||111.48|90.18|
91503459|NCT03971695|182878524|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.63|||||TWO_SIDED|90.0|85.37|98.35|||||Intra-individual geometric coefficient of variance (gCV) = 9.5. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||98.35|85.37|
91503460|NCT03971695|182878525|OTHER||Adjusted geometric mean (gMean) ratio(%)|98.01|||||TWO_SIDED|90.0|84.2|114.08|||||Intra-individual geometric coefficient of variance (gCV) = 20.5. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||114.08|84.20|
91503461|NCT03971695|182878525|OTHER||Adjusted geometric mean (gMean) ratio(%)|77.52|||||TWO_SIDED|90.0|68.11|88.22|||||Intra-individual geometric coefficient of variance (gCV) = 17.4. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||88.22|68.11|
91503462|NCT03971695|182878529|OTHER||Adjusted geometric mean (gMean) ratio(%)|96.42|||||TWO_SIDED|90.0|86.96|106.9|||||Intra-individual geometric coefficient of variance (gCV) = 13.9. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||106.90|86.96|
91503463|NCT03971695|182878529|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.27|||||TWO_SIDED|90.0|85.4|97.54|||||Intra-individual geometric coefficient of variance (gCV) = 8.9. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||97.54|85.40|
91503464|NCT01881230|182878532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.692||||0.0183|TWO_SIDED|95.0|1.089|2.629|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||2.629|1.089|0.0183
91503465|NCT01881230|182878532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.581||||0.0152|TWO_SIDED|95.0|0.373|0.904|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||0.904|0.373|0.0152
91747592|NCT00758264|183387087|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.93|||||TWO_SIDED|95.0|-1.09|8.15||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).||8.15|-1.09|
91747593|NCT00758264|183387087|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.68|||||TWO_SIDED|95.0|-2.11|6.22||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).||6.22|-2.11|
91503466|NCT01881230|182878532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8599|TWO_SIDED|95.0|0.676|1.597|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||1.597|0.676|0.8599
91503467|NCT01881230|182878535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.375||||0.1579|TWO_SIDED|95.0|0.882|2.143|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||2.143|0.882|0.1579
91747594|NCT00758264|183387087|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.25|||||TWO_SIDED|95.0|-0.94|6.76||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).||6.76|-0.94|
91747595|NCT00758264|183387087|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.18|4.6||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).||4.6|-2.18|
91747596|NCT02163967|183387119|OTHER||||||<|0.02||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.||The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation||||<.02
91747597|NCT02163967|183387120|OTHER||||||<|0.001|||||||Chi-squared|||The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.||||<.001
91747598|NCT02163967|183387121|OTHER|||||||0.81||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.81
91747599|NCT02163967|183387122|OTHER|||||||0.47||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.47
91747600|NCT04392141|183387139|EQUIVALENCE|equivalence of odds of death between both groups|Odds Ratio (OR)|9.87||||0.0318|TWO_SIDED|95.0|1.16|83.89|||Fisher Exact|||||83.89|1.16|0.0318
91747601|NCT04392141|183387140|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-5.5||||0.0001|TWO_SIDED|95.0|-7.03|-3.96|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 (%) between admission and discharge times in standard treatment group||-3.96|-7.03|0.0001
91747602|NCT04392141|183387140|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-2.55||||0.0001|TWO_SIDED|95.0|-3.28|-1.81|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-1.81|-3.28|0.0001
91513389|NCT01047683|182898443|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.1||||0.2367|TWO_SIDED|95.0|-12.3|2.2|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||2.2|-12.3|0.2367
91747603|NCT04392141|183387141|EQUIVALENCE|equivalence of means of the length of hospitalization between both groups|Mean Difference (Final Values)|2.22||||0.0001|TWO_SIDED|95.0|1.63|2.8|||Wilcoxon (Mann-Whitney)|||||2.80|1.63|0.0001
91747604|NCT04392141|183387142|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|0.02||||0.8|TWO_SIDED|95.0|-0.136|0.176|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in standard treatment||0.176|-0.136|0.80
91747605|NCT04392141|183387142|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|-0.43||||0.0001|TWO_SIDED|95.0|-0.63|-0.23|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-0.23|-0.63|0.0001
91503468|NCT01881230|182878535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.2945|TWO_SIDED|95.0|0.52|1.221|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.221|0.520|0.2945
91503469|NCT01881230|182878535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101||||0.6691|TWO_SIDED|95.0|0.71|1.708|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.708|0.710|0.6691
91503470|NCT02515942|182878552|SUPERIORITY|Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|Treatment Effect|-0.35||||0.0636|TWO_SIDED|80.0|-0.64|-0.06|||ANCOVA|||||-0.06|-0.64|0.0636
91503471|NCT02515942|182878552|SUPERIORITY||Treatment Effect|-0.29||||0.1019|TWO_SIDED|80.0|-0.59|0.0|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.00|-0.59|0.1019
91503472|NCT02515942|182878552|SUPERIORITY||Treatment Effect|0.06||||0.5987|TWO_SIDED|80.0|-0.24|0.35|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.35|-0.24|0.5987
91747606|NCT04392141|183387143|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|-26.06||||0.602|TWO_SIDED|95.0|-124.76|72.64|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in standard treatment||72.64|-124.76|0.602
91747607|NCT04392141|183387143|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|137.33||||0.006|TWO_SIDED|95.0|38.19|236.46|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||236.46|38.19|0.006
91747608|NCT04295681|183387144|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0006|TWO_SIDED|95.0|0.47|1.7|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of MoCA scores (90th day of treatment minus baseline) were compared.||1.70|0.47|0.0006
91503473|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.5029|TWO_SIDED|80.0|-0.11|0.11|||Mixed Models Analysis|||Change from baseline at Day 85||0.11|-0.11|0.5029
91503474|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.682|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6820
91503475|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.6826|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6826
91531701|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
91747609|NCT04295681|183387145|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.58|0.37|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 12th day of treatment) were compared.||0.37|-0.58|0.67
91747610|NCT04295681|183387145|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.94|TWO_SIDED|95.0|-0.47|0.5|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 90th day of treatment) were compared.||0.50|-0.47|0.94
91747611|NCT04295681|183387146|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Test for comparison percentage of patients with no significant disabilities after 90 days of treatment .||||0.89
91747612|NCT04295681|183387147|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect score comparison on 90th day of treatment.||||0.067
91503476|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.12||||0.1545|TWO_SIDED|80.0|-0.28|0.03|||Mixed Models Analysis|||Change from baseline at Day 169||0.03|-0.28|0.1545
91503477|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.13||||0.1398|TWO_SIDED|80.0|-0.29|0.02|||Mixed Models Analysis|||Change from baseline at Day 169||0.02|-0.29|0.1398
91503478|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.01||||0.4717|TWO_SIDED|80.0|-0.16|0.14|||Mixed Models Analysis|||Change from baseline at Day 169||0.14|-0.16|0.4717
91503479|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.25||||0.053|TWO_SIDED|80.0|-0.45|-0.05|||Mixed Models Analysis|||Change from baseline at Day 253||-0.05|-0.45|0.0530
91503480|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.17||||0.1386|TWO_SIDED|80.0|-0.37|0.03|||Mixed Models Analysis|||Change from baseline at Day 253||0.03|-0.37|0.1386
91503481|NCT02515942|182878553|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.08||||0.7087|TWO_SIDED|80.0|-0.11|0.27|||Mixed Models Analysis|||Change from baseline at Day 253||0.27|-0.11|0.7087
91503482|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.72||||0.9243|TWO_SIDED|80.0|-5.15|-0.29|||Mixed Models Analysis|||Change from baseline at Day 2||-0.29|-5.15|0.9243
91747613|NCT04295681|183387147|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Side effects score comparison on 90th day of treatment.||||0.81
91747614|NCT04295681|183387147|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Efficacy index score comparison on 90th day of treatment.||||0.17
91747615|NCT04295681|183387148|SUPERIORITY|||||||0.656|||||||Fisher Exact|||The percentage of participants having at least one adverse event were compared.||||0.656
91747616|NCT04295681|183387149|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91747617|NCT04295681|183387151|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
91747618|NCT04295681|183387152|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
91747619|NCT04295681|183387153|SUPERIORITY|||||||0.438|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Systolic blood pressure. Analysis of varience (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.438
91747620|NCT04295681|183387153|SUPERIORITY|||||||0.56|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Diastolic blood pressure. Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.56
91747621|NCT04295681|183387154|SUPERIORITY|||||||0.72|||||||Fisher Exact|||Comparison at the baseline.||||0.72
91747622|NCT04295681|183387154|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison on 90th day of treatment.||||1
91747623|NCT04295681|183387155|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91747624|NCT02357472|183387156|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample Size to Achieve 0.80 Power to Test Equivalency at the α = 0.05 Significance Level for True Proportions|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|0.6216|2.002|||t-test, 2 sided|||It was caculated that 60 paticipants randomized in a 1:1between 2 arms would would have at least 85% power to detect a difference of 1.32 oocytes between the high dose group and standard dose group after 12 weeks.Sample size was determined using 2 sided 2 sample t-test (α = 0.05).Assumptions included a common standard deviation of 1.72.||2.002|0.6216|0.0003
91747625|NCT00803400|183387171|OTHER||Mean Difference (Final Values)|1.0|||<|0.001|ONE_SIDED||||||t-test, 1 sided|||A p-value less than 0.05 (≤ 0.05) is statistically significant. It indicates strong evidence against the null hypothesis, as there is less than a 5% probability the null is correct (and the results are random)||||<0.001
91747626|NCT01178944|183387185|OTHER||Mean Difference (Final Values)|1.08||||0.585|TWO_SIDED|95.0|0.78|1.38|||t-test, 2 sided|||Comparison is CR+PR vs stable disease/progression||1.38|0.78|0.585
91747627|NCT04376684|183387237|OTHER||Odds Ratio (OR)|1.32||||0.0456|TWO_SIDED|95.0|0.96|1.82||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.82|0.96|0.0456
91747628|NCT04376684|183387238|OTHER||Odds Ratio (OR)|1.04||||0.8574|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8574
91747629|NCT04376684|183387239|OTHER||Odds Ratio (OR)|0.86||||0.2057|TWO_SIDED|95.0|0.61|1.22||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.22|0.61|0.2057
91747630|NCT04376684|183387240|OTHER||Odds Ratio (OR)|0.79||||0.3061|TWO_SIDED|95.0|0.5|1.24||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.24|0.50|0.3061
91747631|NCT04376684|183387241|OTHER||Odds Ratio (OR)|0.91||||0.6665|TWO_SIDED|95.0|0.59|1.41||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.41|0.59|0.6665
91747632|NCT04376684|183387242|OTHER||Hazard Ratio (HR)|0.88||||0.1942|TWO_SIDED|95.0|0.65|1.18||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.18|0.65|0.1942
91747633|NCT04376684|183387243|OTHER||Hazard Ratio (HR)|0.9||||0.5324|TWO_SIDED|95.0|0.65|1.24||p-value is generated from a two-sided test|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.24|0.65|0.5324
91503483|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.51||||0.3929|TWO_SIDED|80.0|-1.89|2.91|||Mixed Models Analysis|||Change from baseline at Day 2||2.91|-1.89|0.3929
91531702|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
91503484|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.23||||0.0418|TWO_SIDED|80.0|0.85|5.61|||Mixed Models Analysis|||Change from baseline at Day 2||5.61|0.85|0.0418
91531703|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.8|<0.001
91747634|NCT04376684|183387244|OTHER||Odds Ratio (OR)|1.09||||0.2871|TWO_SIDED|95.0|0.8|1.49||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.49|0.80|0.2871
91747635|NCT04376684|183387245|OTHER||Odds Ratio (OR)|1.16||||0.1754|TWO_SIDED|95.0|0.85|1.58||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.58|0.85|0.1754
91747636|NCT04376684|183387246|OTHER||Odds Ratio (OR)|1.29||||0.0616|TWO_SIDED|95.0|0.93|1.79||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.79|0.93|0.0616
91747637|NCT04376684|183387247|OTHER||Odds Ratio (OR)|1.17||||0.183|TWO_SIDED|95.0|0.84|1.63||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.63|0.84|0.1830
91747638|NCT04376684|183387248|OTHER||Odds Ratio (OR)|1.51||||0.0831|TWO_SIDED|95.0|0.95|2.39||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.39|0.95|0.0831
91747639|NCT04376684|183387249|OTHER||Odds Ratio (OR)|1.29||||0.2557|TWO_SIDED|95.0|0.83|2.0||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.00|0.83|0.2557
91747640|NCT04376684|183387250|OTHER||Odds Ratio (OR)|1.04||||0.856|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8560
91747641|NCT04376684|183387251|OTHER||Odds Ratio (OR)|1.07||||0.7533|TWO_SIDED|95.0|0.69|1.66||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.66|0.69|0.7533
91747642|NCT04376684|183387252|OTHER||Hazard Ratio (HR)|1.12||||0.0959|TWO_SIDED|95.0|0.95|1.32||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.32|0.95|0.0959
91747643|NCT04376684|183387253|OTHER||Hazard Ratio (HR)|1.12||||0.4421|TWO_SIDED|95.0|0.84|1.5||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.50|0.84|0.4421
91747644|NCT04376684|183387254|OTHER||Odds Ratio (OR)|1.14||||0.2814|TWO_SIDED|95.0|0.73|1.8||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.80|0.73|0.2814
91747645|NCT04376684|183387255|OTHER||Odds Ratio (OR)|1.04||||0.3901|TWO_SIDED|95.0|0.77|1.42||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.42|0.77|0.3901
91747646|NCT04376684|183387256|OTHER||Odds Ratio (OR)|1.01||||0.4763|TWO_SIDED|95.0|0.75|1.36||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.36|0.75|0.4763
91747647|NCT04376684|183387257|OTHER||Odds Ratio (OR)|1.14||||0.1973|TWO_SIDED|95.0|0.84|1.56||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.56|0.84|0.1973
91503485|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.32||||0.5632|TWO_SIDED|80.0|-2.91|2.27|||Mixed Models Analysis|||Change from baseline at Day 8||2.27|-2.91|0.5632
91747648|NCT04376684|183387258|OTHER||Odds Ratio (OR)|1.21||||0.1173|TWO_SIDED|95.0|0.88|1.67||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.67|0.88|0.1173
91747649|NCT04376684|183387259|OTHER||Odds Ratio (OR)|3.98||||0.0037|TWO_SIDED|95.0|1.57|10.13||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||10.13|1.57|0.0037
91747650|NCT04376684|183387260|OTHER||Odds Ratio (OR)|1.26||||0.3581|TWO_SIDED|95.0|0.77|2.06||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.06|0.77|0.3581
91747651|NCT04376684|183387261|OTHER||Odds Ratio (OR)|0.99||||0.9621|TWO_SIDED|95.0|0.63|1.54||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.54|0.63|0.9621
91747652|NCT04376684|183387262|OTHER||Odds Ratio (OR)|0.83||||0.4167|TWO_SIDED|95.0|0.54|1.29||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.29|0.54|0.4167
91747653|NCT04376684|183387263|OTHER||Odds Ratio (OR)|0.81||||0.3408|TWO_SIDED|95.0|0.53|1.25||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.25|0.53|0.3408
91747654|NCT04376684|183387264|OTHER||Hazard Ratio (HR)|1.02||||0.425|TWO_SIDED|95.0|0.85|1.23||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.23|0.85|0.4250
91747655|NCT04376684|183387265|OTHER||Hazard Ratio (HR)|1.13||||0.4774|TWO_SIDED|95.0|0.81|1.59||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.59|0.81|0.4774
91747656|NCT04376684|183387266|OTHER||Odds Ratio (OR)|0.4||||0.0119|TWO_SIDED|95.0|0.18|0.89||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||0.89|0.18|0.0119
91747657|NCT04376684|183387267|OTHER||Hazard Ratio (HR)|1.02||||0.4404|TWO_SIDED|95.0|0.83|1.24||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.24|0.83|0.4404
91747658|NCT04376684|183387268|OTHER||Hazard Ratio (HR)|1.11||||0.6253|TWO_SIDED|95.0|0.72|1.72||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.72|0.72|0.6253
91747659|NCT04376684|183387269|OTHER||Hazard Ratio (HR)|1.11||||0.1078|TWO_SIDED|95.0|0.94|1.3||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.30|0.94|0.1078
91747660|NCT04376684|183387270|OTHER||Hazard Ratio (HR)|1.11||||0.114|TWO_SIDED|95.0|0.94|1.31||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.31|0.94|0.1140
91747661|NCT04376684|183387271|OTHER||Hazard Ratio (HR)|1.06||||0.7084|TWO_SIDED|95.0|0.8|1.4||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.40|0.80|0.7084
91747662|NCT04376684|183387272|OTHER||Hazard Ratio (HR)|1.13||||0.4085|TWO_SIDED|95.0|0.84|1.52||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.52|0.84|0.4085
91747663|NCT02602275|183387310|SUPERIORITY|||||||0.004||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||0.004
91747664|NCT02602275|183387311|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
91747665|NCT02602275|183387312|SUPERIORITY||||||<|0.001||||||Significance level was 0.05.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but the preceding endpoint was not met.||||||<0.001
91531704|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
91747666|NCT02602275|183387313|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
91747667|NCT02602275|183387314|SUPERIORITY||||||<|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the AAL (Automated Anatomical Labelling Atlas) coordinates.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but a preceding endpoint was not met.||||||<0.05
91747668|NCT02241733|183387317|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||An independent t-test was completed.||||0.94
91747669|NCT02241733|183387318|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
91747670|NCT02241733|183387319|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
91747671|NCT02241733|183387320|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
91747672|NCT01866111|183387345|SUPERIORITY||||||<|0.001|||||||ANCOVA|||A step down procedure was used for the primary efficacy analyses to ensure the type one error rate for multiple comparisons was controlled at the 5% level using the following hierarchy: 200 mg vs placebo, 400 mg vs placebo, 100 mg vs placebo, in which a statistically significant difference had to be detected in this order for each subsequent comparison to occur.||||<0.001
91747673|NCT01866111|183387345|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91747674|NCT01866111|183387345|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
91503486|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2575|TWO_SIDED|80.0|-1.25|3.83|||Mixed Models Analysis|||Change from baseline at Day 8||3.83|-1.25|0.2575
91531705|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
91747675|NCT01866111|183387346|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91747676|NCT01866111|183387346|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91747677|NCT01866111|183387346|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
91747678|NCT01974206|183387361|OTHER||Common Odds Ratio|0.79||||0.307|TWO_SIDED|90.0|0.43|1.47||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization strata, and the 90% CIs of the CMH odds ratio stratified by randomization group.||1.47|0.43|0.307
91747679|NCT01974206|183387362|OTHER||Common Odds Ratio|0.99||||0.576|TWO_SIDED|90.0|0.46|2.15||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||2.15|0.46|0.576
91747680|NCT01974206|183387363|OTHER||Common Odds Ratio|0.88||||0.408|TWO_SIDED|90.0|0.48|1.59||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.59|0.48|0.408
91747681|NCT01974206|183387364|OTHER||Common Odds Ratio|0.88||||0.419|TWO_SIDED|90.0|0.48|1.61||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.61|0.48|0.419
91747682|NCT01974206|183387365|OTHER|||||||0.5||||||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||Exact Cochran-Mantel-Haenszel estimate of the common odds ratio could not be calculated as 100% of ASP0113 group showed graft survival, and this leads to having a value of 0 for the denominator for the ratio thus odds ratio is not estimable. The 90% CI (2-sided) values for the odds ratio are 0.11 to NA, where NA is an infinity value.||||0.5
91747683|NCT04113018|183387367|SUPERIORITY||Response rate|0.5385||||0.375|TWO_SIDED|95.0|0.3718|0.6991|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.||0.6991|0.3718|0.375
91747684|NCT04113018|183387374|OTHER|Estimation only|Rate|0.0513|||||TWO_SIDED|95.0|0.0063|0.1732|||||Confidence interval estimated using the Clopper Pearson method.|||0.1732|0.0063|
91747685|NCT04113018|183387375|OTHER|Estimation only.|Rate|0.0256|||||TWO_SIDED|95.0|0.0006|0.1348|||||Confidence interval estimated using the Clopper Pearson method.|||0.1348|0.0006|
91747686|NCT03802630|183387382|NON_INFERIORITY|Non-inferiority was considered established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is greater than -4 letters.|Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.01||0.018|TWO_SIDED|95.0|-3.9|0.1|||ANOVA|||||0.1|-3.9|0.018
91747687|NCT06099223|183387401|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91747688|NCT06099223|183387402|SUPERIORITY|||||||0.029|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.029
91747689|NCT06099223|183387404|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91747690|NCT06099223|183387405|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91747691|NCT06099223|183387406|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
91747692|NCT06099223|183387407|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
91747693|NCT06099223|183387408|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.11
91747694|NCT06099223|183387409|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91747695|NCT06099223|183387410|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91747696|NCT06099223|183387411|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
91747697|NCT06099223|183387412|SUPERIORITY|||||||0.147|||||||t-test, 2 sided|||||||0.147
91747698|NCT06099223|183387413|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
91747699|NCT06099223|183387414|SUPERIORITY|||||||0.41|||||||Chi-squared|||||||0.41
91747700|NCT06099223|183387415|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
91747701|NCT06099223|183387416|SUPERIORITY|||||||0.58|||||||Chi-squared|||||||0.58
91747702|NCT06099223|183387418|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
91747703|NCT06099223|183387419|SUPERIORITY|||||||0.919|||||||ANCOVA|||||||0.919
91747704|NCT04091581|183387426|OTHER|||||||0.002|||||||ANOVA|||||||0.002
91747705|NCT04091581|183387426|OTHER|||||||0.022|||||||t-test, 2 sided|||Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.||||0.022
91531706|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
91747706|NCT01331837|183387429|NON_INFERIORITY_OR_EQUIVALENCE|In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI \<1.8 was required.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.77|1.43||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.43|0.77|
91747707|NCT01331837|183387431|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62||||||"The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.62|0.76|
91747708|NCT01331837|183387433|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.73|1.4||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.40|0.73|
91747709|NCT01331837|183387435|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.7|1.56||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.56|0.70|
91747710|NCT01331837|183387437|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.34|0.73|
91747711|NCT01331837|183387439|NON_INFERIORITY_OR_EQUIVALENCE|'The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.49||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.49|0.54|
91747712|NCT01331837|183387441|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.64|1.63||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.63|0.64|
91747713|NCT01331837|183387443|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.53|||||TWO_SIDED|95.0|0.8|2.92||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||2.92|0.80|
91747714|NCT01331837|183387445|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.41||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.41|0.70|
91747715|NCT02456636|183387458|SUPERIORITY||Mean Difference (Net)|-1.87||||0.025|TWO_SIDED|97.5|-3.51|-0.23|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling)||-0.23|-3.51|.025
91747716|NCT02456636|183387458|SUPERIORITY||Mean Difference (Net)|-1.36||||0.25|TWO_SIDED|97.5|-3.0|0.29|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.29|-3.00|0.25
91747717|NCT02456636|183387458|SUPERIORITY||Mean Difference (Net)|-0.51||||0.025|TWO_SIDED|97.5|-2.15|1.13|||Mixed Models Analysis|||PCMH (in clinic group visits) versus DM (phone group visits)||1.13|-2.15|.025
91747718|NCT02456636|183387459|SUPERIORITY||Median Difference (Net)|-1.84||||0.025|TWO_SIDED|97.5|-3.5|-0.18|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling).||-0.18|-3.50|.025
91503487|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.61||||0.2058|TWO_SIDED|80.0|-0.91|4.12|||Mixed Models Analysis|||Change from baseline at Day 8||4.12|-0.91|0.2058
91503488|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8392|TWO_SIDED|80.0|-4.44|0.57|||Mixed Models Analysis|||Change from baseline at Day 15||0.57|-4.44|0.8392
91503489|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effecgt|-0.12||||0.5255|TWO_SIDED|80.0|-2.59|2.35|||Mixed Models Analysis|||Change from baseline at Day 15||2.35|-2.59|0.5255
91503490|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.81||||0.1685|TWO_SIDED|80.0|-0.61|4.24|||Mixed Models Analysis|||Change from baseline at Day 15||4.24|-0.61|0.1685
91747719|NCT02456636|183387459|SUPERIORITY||Median Difference (Net)|-1.34||||0.025|TWO_SIDED|97.5|-2.99|0.32|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.32|-2.99|.025
91531707|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
91747720|NCT02456636|183387459|SUPERIORITY||Mean Difference (Net)|-0.5||||0.025|TWO_SIDED|97.5|-2.15|1.15|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus DM (phone group counseling)||1.15|-2.15|.025
91747721|NCT05312632|183387478|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91747722|NCT05312632|183387479|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91747723|NCT05312632|183387480|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91747724|NCT05312632|183387481|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91747725|NCT05312632|183387482|OTHER|||||||0.013|||||||Wilcoxon signed rank test|||||||0.013
91747726|NCT05312632|183387483|OTHER|||||||0.053|||||||Wilcoxon signed rank test|||||||0.053
91747727|NCT05312632|183387484|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
91747728|NCT03130439|183387529|OTHER||Objective Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.247||||||||0.247|0.000|
91747729|NCT03130439|183387532|OTHER||Disease Control Rate|0.222|||||TWO_SIDED|95.0|0.086|0.423||||||||0.423|0.086|
91503491|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment|-2.01||||0.8544|TWO_SIDED|80.0|-4.45|0.43|||Mixed Models Analysis|||Change from baseline at Day 29||0.43|-4.45|0.8544
91747730|NCT03130439|183387533|OTHER||Clinical Benefit Rate|0.148|||||TWO_SIDED|95.0|0.042|0.337||||||||0.337|0.042|
91747731|NCT02731820|183387534|OTHER|||||||0.172|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.172
91747732|NCT02731820|183387534|OTHER|||||||0.027|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.027
91747733|NCT02731820|183387534|OTHER|||||||0.053|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.053
91747734|NCT02731820|183387534|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
91747735|NCT02731820|183387534|OTHER|||||||0.006|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.006
91747736|NCT02731820|183387534|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
91747737|NCT02731820|183387534|OTHER|||||||0.967|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.967
91747738|NCT02731820|183387534|OTHER|||||||0.446|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.446
91747739|NCT02731820|183387534|OTHER|||||||0.869|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.869
91747740|NCT02731820|183387535|OTHER|||||||0.954|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.954
91747741|NCT02731820|183387535|OTHER|||||||0.798|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.798
91747742|NCT02731820|183387535|OTHER|||||||0.377|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.377
91747743|NCT02731820|183387535|OTHER|||||||0.886|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.886
91747744|NCT02731820|183387535|OTHER|||||||0.04|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.040
91747745|NCT02731820|183387535|OTHER|||||||0.017|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.017
91747746|NCT02731820|183387535|OTHER|||||||0.343|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.343
91747747|NCT02731820|183387535|OTHER|||||||0.859|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.859
91747748|NCT02731820|183387535|OTHER|||||||0.172|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.172
91747749|NCT02731820|183387536|OTHER|||||||0.213|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.213
91747750|NCT02731820|183387536|OTHER|||||||0.191|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.191
91747751|NCT02731820|183387536|OTHER|||||||0.234|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.234
91747752|NCT02731820|183387536|OTHER|||||||0.37|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.370
91747753|NCT02731820|183387536|OTHER|||||||0.176|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.176
91747754|NCT02731820|183387536|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
91747755|NCT02731820|183387536|OTHER|||||||0.551|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.551
91503492|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.03||||0.1402|TWO_SIDED|80.0|-0.38|4.44|||Mixed Models Analysis|||Change from baseline at Day 29||4.44|-0.38|0.1402
91503493|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.03||||0.015|TWO_SIDED|80.0|1.67|6.4|||Mixed Models Analysis|||Change from baseline at Day 29||6.40|1.67|0.0150
91747756|NCT02731820|183387536|OTHER|||||||0.371|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.371
91747757|NCT02731820|183387536|OTHER|||||||0.466|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.466
91747758|NCT02731820|183387537|OTHER|||||||0.094|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.094
91747759|NCT02731820|183387537|OTHER|||||||0.0004|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.0004
91747760|NCT02731820|183387537|OTHER|||||||0.008|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.008
91747761|NCT02731820|183387537|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
91747762|NCT02731820|183387537|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||<0.0001
91747763|NCT02731820|183387537|OTHER|||||||0.0007|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.0007
91747764|NCT02731820|183387537|OTHER|||||||0.458|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.458
91747765|NCT02731820|183387537|OTHER|||||||0.434|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.434
91747766|NCT02731820|183387537|OTHER|||||||0.555|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.555
91747767|NCT04838054|183387538|SUPERIORITY||Mean Difference (Net)|0.27||||0.28|TWO_SIDED|||||p-values \<0.05 means statistically significant|ANCOVA|||||||0.28
91747768|NCT04838054|183387539|SUPERIORITY||Mean Difference (Net)|0.41||||0.011|TWO_SIDED|||||p\<0.05 means statistically significant|ANCOVA|||||||0.011
91747769|NCT04838054|183387540|SUPERIORITY||Mean Difference (Net)|2.99|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91747770|NCT02743949|183387541|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0584||||0.748|TWO_SIDED|97.5|0.71|1.5778||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.5778|0.7100|0.7480
91747771|NCT02743949|183387541|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0975||||0.5985|TWO_SIDED|97.5|0.7368|1.6349||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.6349|0.7368|0.5985
91747772|NCT02743949|183387542|SUPERIORITY||Miettinen-Nurminen|0.91||||0.782|TWO_SIDED|97.5|0.44|1.91||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||1.91|0.44|0.782
91747773|NCT02743949|183387542|SUPERIORITY||Miettinen-Nurminen|0.96||||0.912|TWO_SIDED|97.5|0.46|2.01||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||2.01|0.46|0.912
91747774|NCT01126437|183387563|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.837|1.094|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.094|0.837|
91747775|NCT01126437|183387563|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.996|||||TWO_SIDED|95.0|0.872|1.136|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.136|0.872|
91747776|NCT01126437|183387564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.978||||0.4194|TWO_SIDED|95.0|0.928|1.032|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.032|0.928|0.4194
91747777|NCT01126437|183387564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.016||||0.5593|TWO_SIDED|95.0|0.964|1.07|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.070|0.964|0.5593
91747778|NCT01126437|183387564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.038||||0.1639|TWO_SIDED|95.0|0.985|1.094|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.094|0.985|0.1639
91759522|NCT02391363|183411773|SUPERIORITY|"We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||||0.52||||||Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||||||0.52
91747779|NCT01126437|183387565|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.038|0.018||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||0.018|-.038|
91747780|NCT01126437|183387565|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.065|-0.009||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||-.009|-.065|
91747781|NCT01126437|183387566|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.833|TWO_SIDED|95.0|0.95|1.06|||Negative binomial regression|||||1.06|0.95|0.8330
91747782|NCT01126437|183387566|SUPERIORITY_OR_OTHER||Rate ratio of events|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.8047|TWO_SIDED|95.0|0.94|1.05|||Negative binomial regression|||||1.05|0.94|0.8047
91747783|NCT01126437|183387566|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.6468|TWO_SIDED|95.0|0.96|1.07|||Negative binomial regression|||||1.07|0.96|0.6468
91747784|NCT01126437|183387567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.1762|TWO_SIDED|95.0|0.971|1.176|||Regression, Cox|||||1.176|0.971|0.1762
91747785|NCT01126437|183387567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.6384|TWO_SIDED|95.0|0.929|1.128|||Regression, Cox|||||1.128|0.929|0.6384
91747786|NCT01126437|183387567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.044||||0.3784|TWO_SIDED|95.0|0.949|1.148|||Regression, Cox|||||1.148|0.949|0.3784
91747787|NCT01126437|183387568|SUPERIORITY_OR_OTHER||Rate ratio of events|1.09|STANDARD_ERROR_OF_MEAN|0.06||0.1255|TWO_SIDED|95.0|0.98|1.22||p-value from negative binomial regression.|Negative binomial regression|||||1.22|0.98|0.1255
91747788|NCT01126437|183387568|SUPERIORITY_OR_OTHER||Rate ratio of events|1.06|STANDARD_ERROR_OF_MEAN|0.06||0.3441|TWO_SIDED|95.0|0.94|1.18||p-value from negative binomial regression.|Negative binomial regression|||||1.18|0.94|0.3441
91747789|NCT01126437|183387568|SUPERIORITY_OR_OTHER||Rate ratio of events|1.03|STANDARD_ERROR_OF_MEAN|0.06||0.5573|TWO_SIDED|95.0|0.92|1.16||p-value from negative binomial regression.|Negative binomial regression|||||1.16|0.92|0.5573
91747790|NCT01126437|183387569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.6823|TWO_SIDED|95.0|0.959|1.066|||Regression, Cox|||||1.066|0.959|0.6823
91747791|NCT01126437|183387569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983||||0.5377|TWO_SIDED|95.0|0.932|1.037|||Regression, Cox|||||1.037|0.932|0.5377
91747792|NCT01126437|183387569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.028||||0.3048|TWO_SIDED|95.0|0.975|1.084|||Regression, Cox|||||1.084|0.975|0.3048
91747793|NCT01126437|183387570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.105||||0.3043|TWO_SIDED|95.0|0.913|1.336|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.336|0.913|0.3043
91747794|NCT01126437|183387570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.3263|TWO_SIDED|95.0|0.909|1.331|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.331|0.909|0.3263
91747795|NCT01126437|183387570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9644|TWO_SIDED|95.0|0.834|1.209|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.209|0.834|0.9644
91747796|NCT01126437|183387571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2439|TWO_SIDED|95.0|0.898|1.526|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.526|0.898|0.2439
91747797|NCT01126437|183387571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.4413|TWO_SIDED|95.0|0.85|1.453|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.453|0.850|0.4413
91747798|NCT01126437|183387571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054||||0.691|TWO_SIDED|95.0|0.814|1.363|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.363|0.814|0.6910
91747799|NCT01220973|183387575|OTHER||Slope|0.74|||||TWO_SIDED|||||||||||||
91747800|NCT01453205|183387633|SUPERIORITY_OR_OTHER|||||||0.5543|||||||Cochran-Mantel-Haenszel|||||||0.5543
91747801|NCT01453205|183387634|SUPERIORITY_OR_OTHER|||||||0.8567|||||||Log Rank|||||||0.8567
91747802|NCT01453205|183387635|SUPERIORITY_OR_OTHER|||||||0.7412|||||||Log Rank|||||||0.7412
91747803|NCT01453205|183387636|SUPERIORITY_OR_OTHER|||||||0.9996|||||||Log Rank|||||||0.9996
91747804|NCT01453205|183387637|SUPERIORITY_OR_OTHER|||||||0.1686|||||||Log Rank|||||||0.1686
91747805|NCT02333396|183387712|SUPERIORITY||Beta Estimate|3.57|STANDARD_ERROR_OF_MEAN|4.53||0.44|TWO_SIDED|95.0|-5.77|12.9|||Mixed Models Analysis|||||12.9|-5.77|0.44
91747806|NCT02333396|183387713|SUPERIORITY||Beta Estimate|3.62|STANDARD_ERROR_OF_MEAN|2.05||0.09|TWO_SIDED|95.0|-0.61|7.84|||Mixed Models Analysis|||||7.84|-0.61|0.09
91747807|NCT02333396|183387714|SUPERIORITY||Beta Estimate|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.05|TWO_SIDED|95.0|-0.09|8.36|||Mixed Models Analysis|||||8.36|-0.09|0.05
91503494|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.14||||0.4682|TWO_SIDED|80.0|-2.11|2.39|||Mixed Models Analysis|||Change from baseline at Day 30||2.39|-2.11|0.4682
91531708|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.6|<0.001
91747808|NCT02333396|183387715|SUPERIORITY||Beta Estimare|3.02|STANDARD_ERROR_OF_MEAN|2.26||0.19|TWO_SIDED|95.0|-1.63|7.67|||Mixed Models Analysis|||||7.67|-1.63|0.19
91747809|NCT02333396|183387716|SUPERIORITY||Beta Estimate|-0.22|STANDARD_ERROR_OF_MEAN|2.47||0.93|TWO_SIDED|95.0|-5.33|4.88|||Mixed Models Analysis|||||4.88|-5.33|0.93
91747810|NCT02333396|183387717|SUPERIORITY||Beta Estimate|-0.35|STANDARD_ERROR_OF_MEAN|1.29||0.79|TWO_SIDED|95.0|-3.02|2.31|||Mixed Models Analysis|||||2.31|-3.02|0.79
91747811|NCT02333396|183387720|SUPERIORITY||Beta Estimate|0.49|STANDARD_ERROR_OF_MEAN|1.03||0.64|TWO_SIDED|95.0|-2.62|1.64|||Mixed Models Analysis|||||1.64|-2.62|0.64
91747812|NCT02333396|183387721|SUPERIORITY||Beta Estimate|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.39|TWO_SIDED|95.0|-3.02|1.22|||Mixed Models Analysis|||||1.22|-3.02|0.39
91747813|NCT02333396|183387723|SUPERIORITY||Beta Estiamte|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
91747814|NCT02333396|183387724|SUPERIORITY||Beta Estimate|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
91747815|NCT02059499|183387729|SUPERIORITY|||||||0.1877||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1877
91747816|NCT02059499|183387730|SUPERIORITY|||||||0.1068||||||A priori threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1068
91747817|NCT02059499|183387731|SUPERIORITY|||||||0.8071||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.8071
91747818|NCT02059499|183387732|SUPERIORITY|||||||0.6562||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.6562
91747819|NCT02059499|183387733|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
91747820|NCT02059499|183387734|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
91747821|NCT02059499|183387738|SUPERIORITY|||||||0.1409||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.1409
91747822|NCT02059499|183387739|SUPERIORITY|||||||0.0805||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.0805
91747823|NCT02059499|183387741|SUPERIORITY|||||||0.5726|||||||Cochran-Mantel-Haenszel|||||||0.5726
91747824|NCT02059499|183387742|SUPERIORITY|||||||0.6184||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.6184
91747825|NCT02059499|183387744|EQUIVALENCE|Comparison of mean between count of hrHPV genotypes observed at baseline vs at week 20 in imiquimod arm||||||0.3||||||A priori threshold for interpreting significance : 0.05|Wilcoxon (Mann-Whitney)|||Comparison of number of hrHPV genotypes in each arm observed at baseline vs at week 20 in imiquimod arm||||0.3
91747826|NCT02059499|183387744|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||||0.3||||||A priori threshold to interpret significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||0.3
91747827|NCT02059499|183387744|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||||0.26||||||A priori cutoff of significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||0.26
91747828|NCT03989349|183387753|OTHER||Strata-adjusted percentage difference|12.2||||0.0006|TWO_SIDED|97.5|4.6|19.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||19.8|4.6|0.0006
91747829|NCT03989349|183387754|OTHER||Strata-adjusted percentage difference|14.9||||0.0008|TWO_SIDED|97.5|5.6|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|5.6|0.0008
91747830|NCT03989349|183387755|OTHER||Strata-adjusted percentage difference|12.5||||0.0006|TWO_SIDED|97.5|4.6|20.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||20.3|4.6|0.0006
91747831|NCT03989349|183387756|OTHER||Strata-adjusted percentage difference|16.3||||0.0004|TWO_SIDED|97.5|6.6|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.0|6.6|0.0004
91747832|NCT03989349|183387757|OTHER||Strata-adjusted percentage difference|23.2|||<|0.0001|TWO_SIDED|97.5|16.1|30.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||30.3|16.1|<0.0001
91747833|NCT03989349|183387757|OTHER||Strata-adjusted percentage difference|27.8|||<|0.0001|TWO_SIDED|97.5|21.2|34.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.5|21.2|<0.0001
91747834|NCT03989349|183387758|OTHER||Strata-adjusted percentage difference|27.1|||<|0.0001|TWO_SIDED|97.5|17.5|36.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||36.6|17.5|<0.0001
91747835|NCT03989349|183387758|OTHER||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|97.5|24.5|42.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||42.3|24.5|<0.0001
91747836|NCT03989349|183387759|OTHER||Strata-adjusted percentage difference|17.1|||<|0.0001|TWO_SIDED|97.5|10.9|23.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||23.3|10.9|<0.0001
91747837|NCT03989349|183387760|OTHER||Strata-adjusted percentage difference|18.4|||<|0.0001|TWO_SIDED|97.5|11.0|25.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.8|11.0|<0.0001
91747838|NCT03989349|183387761|OTHER||Strata-adjusted percentage difference|17.5|||<|0.0001|TWO_SIDED|97.5|10.8|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|10.8|< 0.0001
91747839|NCT03989349|183387762|OTHER||Strata-adjusted percentage difference|21.9|||<|0.0001|TWO_SIDED|97.5|12.5|31.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||31.4|12.5|<0.0001
91747840|NCT03989349|183387763|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.6|26.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting the randomized stratification variables (IGA severity and PP NRS).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.1|15.6|< 0.0001
91747841|NCT03989349|183387764|OTHER||Strata-adjusted percentage difference|22.5|||<|0.0001|TWO_SIDED|97.5|15.0|29.9||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||29.9|15.0|<0.0001
91747842|NCT03989349|183387765|OTHER||Strata-adjusted percentage difference|13.2|||<|0.0001|TWO_SIDED|97.5|9.0|17.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||17.4|9|< 0.0001
91747843|NCT03989349|183387766|OTHER||Strata-adjusted percentage difference|9.9||||0.0001|TWO_SIDED|97.5|5.5|14.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.3|5.5|0.0001
91747844|NCT03989349|183387767|OTHER||Strata-adjusted percentage difference|15.1|||<|0.0001|TWO_SIDED|97.5|11.0|19.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level||19.2|11|< 0.0001
91747845|NCT03989349|183387768|OTHER||Strata-adjusted percentage difference|16.3|||<|0.0001|TWO_SIDED|97.5|10.5|22.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.1|10.5|<0.0001
91747846|NCT03989349|183387769|OTHER||Strata-adjusted percentage difference|6.4|||<|0.0001|TWO_SIDED|97.5|3.8|9.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||9.1|3.8|<0.0001
91747847|NCT03989349|183387770|OTHER||Strata-adjusted percentage difference|8.0||||0.0004|TWO_SIDED|97.5|4.2|11.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||11.8|4.2|0.0004
91747848|NCT02684058|183387771|SUPERIORITY|one-sided p-value at 2.5% level of significance|Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.3|22.4|||Chi-squared|||||22.4|2.3|<0.001
91747849|NCT02684058|183387776|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|95.0|0.17|0.55||Log-rank test at an overall one-sided 2.5% level of significance|Log Rank|||Up to approx. 3 years||0.55|0.17|<0.001
91747850|NCT01252186|183387847|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|-11.54||||0.958|TWO_SIDED|95.0|-440.1|417.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||417.0|-440.1|0.958
91747851|NCT01252186|183387847|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|422.76||||0.06|TWO_SIDED|95.0|-18.3|863.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||863.8|-18.3|0.060
91747852|NCT01252186|183387848|SUPERIORITY_OR_OTHER||Treatment Difference|-14.31||||0.745|TWO_SIDED|95.0|-100.8|72.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||72.2|-100.8|0.745
91747853|NCT01252186|183387848|SUPERIORITY_OR_OTHER||Treatment Difference|71.31||||0.115|TWO_SIDED|95.0|-17.5|160.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||160.1|-17.5|0.115
91747854|NCT01252186|183387849|SUPERIORITY_OR_OTHER||Treatment Difference|-17.14||||0.782|TWO_SIDED|95.0|-139.4|105.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||105.1|-139.4|0.782
91747855|NCT01252186|183387849|SUPERIORITY_OR_OTHER||Treatment Difference|97.09||||0.131|TWO_SIDED|95.0|-29.2|223.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||223.4|-29.2|0.131
91747856|NCT01252186|183387850|SUPERIORITY_OR_OTHER||Treatment Difference|-0.04||||0.428|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.1|0.428
91747857|NCT01252186|183387850|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.002|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.1|-0.3|0.002
91747858|NCT01252186|183387851|SUPERIORITY_OR_OTHER||Treatment Difference|-0.01||||0.868|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.2|0.868
91747859|NCT01252186|183387851|SUPERIORITY_OR_OTHER||Treatment Difference|0.2||||0.012|TWO_SIDED|95.0|0.0|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|0.0|0.012
91747860|NCT01252186|183387852|SUPERIORITY_OR_OTHER||Treatment Difference|0.09||||0.317|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-0.1|0.317
91747861|NCT01252186|183387852|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.081|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.0|-0.4|0.081
91747862|NCT01252186|183387853|SUPERIORITY_OR_OTHER||Treatment Difference|-0.004||||0.331|TWO_SIDED|95.0|-0.013|0.004|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.004|-0.013|0.331
91747863|NCT01252186|183387853|SUPERIORITY_OR_OTHER||Treatment Difference|-0.006||||0.173|TWO_SIDED|95.0|-0.015|0.003|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.003|-0.015|0.173
91747864|NCT01252186|183387854|SUPERIORITY_OR_OTHER||Treatment Difference|-0.57||||0.194|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-1.4|0.194
91747865|NCT01252186|183387854|SUPERIORITY_OR_OTHER||Treatment Difference|-0.02||||0.967|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.9|-0.9|0.967
91747866|NCT01252186|183387855|SUPERIORITY_OR_OTHER||Treatment Difference|1.09||||0.648|TWO_SIDED|95.0|-3.6|5.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.8|-3.6|0.648
91747867|NCT01252186|183387855|SUPERIORITY_OR_OTHER||Treatment Difference|1.68||||0.496|TWO_SIDED|95.0|-3.2|6.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||6.6|-3.2|0.496
91747868|NCT01252186|183387856|SUPERIORITY_OR_OTHER||Treatment Difference|8.71||||0.405|TWO_SIDED|95.0|-11.9|29.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||29.3|-11.9|0.405
91747869|NCT01252186|183387856|SUPERIORITY_OR_OTHER||Treatment Difference|28.95||||0.008|TWO_SIDED|95.0|7.7|50.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||50.2|7.7|0.008
91747870|NCT01252186|183387857|SUPERIORITY_OR_OTHER||Treatment Difference|3.3||||0.425|TWO_SIDED|195.0|-4.9|11.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.5|-4.9|0.425
91747871|NCT01252186|183387857|SUPERIORITY_OR_OTHER||Treatment Difference|8.76||||0.041|TWO_SIDED|95.0|0.3|17.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||17.2|0.3|0.041
91747872|NCT01252186|183387858|SUPERIORITY_OR_OTHER||Treatment Difference|-2.4||||0.088|TWO_SIDED|95.0|-5.2|0.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.4|-5.2|0.088
91747873|NCT01252186|183387858|SUPERIORITY_OR_OTHER||Treatment Difference|-3.19||||0.028|TWO_SIDED|95.0|-6.0|-0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.3|-6.0|0.028
91747874|NCT01252186|183387859|SUPERIORITY_OR_OTHER||Treatment Difference|1.75||||0.631|TWO_SIDED|95.0|-5.4|8.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||8.9|-5.4|0.631
91747875|NCT01252186|183387859|SUPERIORITY_OR_OTHER||Treatment Difference|3.73||||0.323|TWO_SIDED|95.0|-3.7|11.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.2|-3.7|0.323
91747876|NCT01252186|183387860|SUPERIORITY_OR_OTHER||Treatment Difference|-0.86||||0.783|TWO_SIDED|595.0|-7.0|5.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.3|-7.0|0.783
91747877|NCT01252186|183387860|SUPERIORITY_OR_OTHER||Treatment Difference|-2.83||||0.384|TWO_SIDED|95.0|-9.2|3.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.6|-9.2|0.384
91747878|NCT01252186|183387861|SUPERIORITY_OR_OTHER||Treatment Difference|1.66||||0.572|TWO_SIDED|95.0|-4.1|7.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||7.5|-4.1|0.572
91747879|NCT01252186|183387861|SUPERIORITY_OR_OTHER||Treatment Difference|-20.98|||<|0.001|TWO_SIDED|95.0|-27.0|-15.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-15.0|-27.0|<0.001
91747880|NCT01252186|183387862|SUPERIORITY_OR_OTHER||Treatment Difference|-0.42||||0.841|TWO_SIDED|95.0|-4.6|3.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.7|-4.6|0.841
91747881|NCT01252186|183387862|SUPERIORITY_OR_OTHER||Treatment Difference|-10.53|||<|0.001|TWO_SIDED|95.0|-14.8|-6.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-6.3|-14.8|<0.001
91503495|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.38||||0.4125|TWO_SIDED|80.0|-1.84|2.6|||Mixed Models Analysis|||Change from baseline at Day 30||2.60|-1.84|0.4125
91531709|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.4|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-0.4|0.033
91747882|NCT01252186|183387863|SUPERIORITY_OR_OTHER||Treatment Difference|-2.11||||0.227|TWO_SIDED|95.0|-5.6|1.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||1.3|-5.6|0.227
91747883|NCT01252186|183387863|SUPERIORITY_OR_OTHER||Treatment Difference|-5.99||||0.001|TWO_SIDED|95.0|-9.6|-2.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-2.4|-9.6|0.001
91747884|NCT01252186|183387864|SUPERIORITY_OR_OTHER||Treatment Difference|0.33||||0.076|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.7|-0.0|0.076
91747885|NCT01252186|183387864|SUPERIORITY_OR_OTHER||Treatment Difference|0.44||||0.021|TWO_SIDED|95.0|0.1|0.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.8|0.1|0.021
91503496|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.24||||0.4431|TWO_SIDED|80.0|-1.94|2.42|||Mixed Models Analysis|||Change from baseline at Day 30||2.42|-1.94|0.4431
91747886|NCT01252186|183387865|SUPERIORITY_OR_OTHER||Treatment Difference|44.46||||0.19|TWO_SIDED|95.0|-22.3|111.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.2|-22.3|0.190
91747887|NCT01252186|183387865|SUPERIORITY_OR_OTHER||Treatment Difference|9.74||||0.781|TWO_SIDED|95.0|-59.4|78.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||78.9|-59.4|0.781
91747888|NCT01252186|183387866|SUPERIORITY_OR_OTHER||Treatment Difference|-12.49||||0.843|TWO_SIDED|95.0|-136.4|111.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.4|-136.4|0.843
91747889|NCT01252186|183387866|SUPERIORITY_OR_OTHER||Treatment Difference|58.3||||0.376|TWO_SIDED|95.0|-71.3|187.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||187.9|-71.3|0.376
91747890|NCT01252186|183387867|SUPERIORITY_OR_OTHER||Treatment Difference|-4.01||||0.731|TWO_SIDED|95.0|-27.0|19.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||19.0|-27.0|0.731
91747891|NCT01252186|183387867|SUPERIORITY_OR_OTHER||Treatment Difference|130.15|||<|0.001|TWO_SIDED|95.0|106.2|154.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||154.1|106.2|<0.001
91747892|NCT03172884|183387874|OTHER||LS means|1.385|||||TWO_SIDED|90.0|0.921|2.081||||||Moderate Hepatic Impairment vs Healthy Subjects||2.081|0.921|
91747893|NCT03172884|183387874|OTHER||LS means|1.445|||||TWO_SIDED|90.0|0.998|2.093||||||Severe hepatic impairment group vs Healthy Subjects||2.093|0.998|
91747894|NCT03172884|183387874|OTHER||LS means|0.646|||||TWO_SIDED|90.0|0.486|0.858||||||Severe renal impairment group vs Healthy Subjects||0.858|0.486|
91747895|NCT03172884|183387875|OTHER||LS Means|1.711|||||TWO_SIDED|90.0|1.148|2.55||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.550|1.148|
91747896|NCT03172884|183387875|OTHER||LS Means|2.705|||||TWO_SIDED|90.0|2.115|3.46||||||Severe hepatic impairment group vs Healthy Subjects||3.460|2.115|
91747897|NCT03172884|183387875|OTHER||LS Means|1.075|||||TWO_SIDED|90.0|0.696|1.659||||||Severe renal impairment group vs Healthy Subjects||1.659|0.696|
91747898|NCT03172884|183387876|OTHER||LS Means|1.768|||||TWO_SIDED|90.0|1.251|2.498||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.498|1.251|
91747899|NCT03172884|183387876|OTHER||LS Means|2.735|||||TWO_SIDED|90.0|2.163|3.459||||||Severe hepatic impairment group vs Healthy Subjects||3.459|2.163|
91747900|NCT03172884|183387876|OTHER||LS Means|1.124|||||TWO_SIDED|90.0|0.815|1.549||||||Severe renal impairment group vs Healthy Subjects||1.549|0.815|
91747901|NCT00778258|183387899|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.77||||0.58|TWO_SIDED|95.0|0.31|1.93|||Regression, Logistic|||||1.93|0.31|0.58
91747902|NCT00778258|183387900|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.13||||0.78|TWO_SIDED|95.0|0.48|2.68|||Chi-squared|||Progression comparison at 12 Months||2.68|0.48|0.78
91747903|NCT00778258|183387900|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.81||||0.62|TWO_SIDED|95.0|0.34|1.91|||Chi-squared|||Progression comparison at 24 Months||1.91|0.34|0.62
91747904|NCT00778258|183387901|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||Comparison at 12 Months||||0.14
91747905|NCT00778258|183387901|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Chi-squared|||Comparison at 24 Months||||0.17
91747906|NCT00778258|183387901|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Chi-squared|||Comparison at 36 Months||||0.33
91747907|NCT00778258|183387902|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||||||0.41
91747908|NCT00778258|183387903|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Kruskal-Wallis|||||||0.09
91747909|NCT00778258|183387903|SUPERIORITY_OR_OTHER|||||||0.01||||||Null hypothesis is that correlation = 0|Spearman's Correlation|||||||0.01
91747910|NCT00778258|183387904|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Betalactoglobulin||||<0.01
91747911|NCT00778258|183387904|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Betalactoglobulin IgE||||<0.01
91747912|NCT00778258|183387904|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Casein IgE||||<0.01
91747913|NCT00778258|183387904|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Casein IgE||||<0.01
91747914|NCT00778258|183387904|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Cow's Milk IgE||||<0.01
91747915|NCT00778258|183387904|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Cow's Milk IgE||||<0.01
91747916|NCT00778258|183387905|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||Analysis on Max Basophil Assessment||||0.01
91747917|NCT00778258|183387905|SUPERIORITY_OR_OTHER|||||||0.22||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Max Basophil Assessment||||0.22
91747918|NCT00778258|183387905|SUPERIORITY_OR_OTHER|||||||0.59|||||||Kruskal-Wallis|||Analysis on Tregs||||0.59
91747919|NCT00778258|183387905|SUPERIORITY_OR_OTHER|||||||0.32||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Tregs||||0.32
91747920|NCT00778258|183387906|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Kruskal-Wallis|||||||0.50
91747921|NCT00778258|183387907|SUPERIORITY_OR_OTHER|||||||0.033||||||Correlation = -0.18|Spearman Correlation|||Baseline Comparison||||0.033
91747922|NCT00778258|183387907|SUPERIORITY_OR_OTHER|||||||0.002||||||Correlation = -0.34|Spearman Correlation|||Month 12 Comparison||||0.002
91747923|NCT00778258|183387907|SUPERIORITY_OR_OTHER|||||||0.156||||||Correlation = -0.20|Spearman Correlation|||Month 24 Comparison||||0.156
91747924|NCT00778258|183387907|SUPERIORITY_OR_OTHER|||||||0.077||||||Correlation = -0.27|Spearman Correlation|||Month 36 Comparison||||0.077
91747925|NCT00778258|183387908|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||36 Month Comparison||||<0.01
91747926|NCT01221623|183387911|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||ANOVA|||||||.0059
91747927|NCT01221623|183387912|SUPERIORITY_OR_OTHER|||||||0.0496|TWO_SIDED||||||ANOVA|||||||.0496
91747928|NCT01221623|183387913|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91747929|NCT01221623|183387914|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||ANOVA|||||||.0340
91747930|NCT01221623|183387915|SUPERIORITY_OR_OTHER|||||||0.1168|TWO_SIDED||||||ANOVA|||||||.1168
91747931|NCT01221623|183387916|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANOVA|||||||.0144
91747932|NCT01221623|183387917|SUPERIORITY_OR_OTHER|||||||0.0248|TWO_SIDED||||||ANOVA|||||||.0248
91747933|NCT01221623|183387918|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||ANOVA|||||||.6949
91747934|NCT01221623|183387919|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||.0249
91747935|NCT00661726|183387920|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
91747936|NCT00661726|183387922|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.045
91747937|NCT00661726|183387923|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.083
91747938|NCT00661726|183387924|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.039
91747939|NCT00661726|183387925|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
91747940|NCT00661726|183387926|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
91747941|NCT00661726|183387927|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.069
91747942|NCT00661726|183387928|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
91747943|NCT00661726|183387929|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.022
91747944|NCT00661726|183387930|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.11
91747945|NCT00661726|183387931|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
91747946|NCT02644096|183387932|SUPERIORITY_OR_OTHER||||||<|0.05||||||Changes in physical function after 3 months|unpaired t-test|||"Power calculation in this study was based on findings in a previous cross-sectional study.~The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups."||||<0.05
91747947|NCT02438384|183387957|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|1.2|2.1||||||||2.1|1.2|
91747948|NCT02438384|183387957|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
91747949|NCT01263015|183387965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.3||||0.003|TWO_SIDED|95.0|2.3|12.2||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||12.2|2.3|0.003
91747950|NCT01263015|183387967|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.2|13.1||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||13.1|1.2|0.016
91747951|NCT01263015|183387967|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \>-10%.|Difference in percentage|8.3||||0.01|TWO_SIDED|95.0|1.9|14.6||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||14.6|1.9|0.010
91747952|NCT01263015|183387970|NON_INFERIORITY_OR_EQUIVALENCE|Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment\*visit interaction, BL HIV-1 RNA\*visit interaction and BL CD4 cell count\*visit interaction. No assumptions were made about the correlations between a par.'s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.||||||0.003||95.0||||P-value is for the test of superiority.|Repeated Measure Mixed Model|||||||0.003
91747953|NCT00303446|183387987|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Generalized estimating equation model|The analysis includes percent change from baseline at 12 and 24 months.||||||0.28
91747954|NCT00303446|183387988|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.86
91747955|NCT00303446|183387989|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||Comparison of changes from baseline in manual muscle testing results.||||0.47
91747956|NCT00303446|183387990|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.13
91747957|NCT00303446|183387991|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.46
91747958|NCT00303446|183387992|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.11
91747959|NCT00303446|183387993|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.08
91747960|NCT00303446|183387994|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.73
91747961|NCT00303446|183387995|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.37
91747962|NCT00303446|183387996|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.65
91747963|NCT00303446|183387997|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.99
91747964|NCT00303446|183387998|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||1.0
91747965|NCT00303446|183387999|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.014
91747966|NCT00303446|183388000|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.|t-test, 2 sided|||||||0.033
91747967|NCT00303446|183388001|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.61
91747968|NCT00450294|183388002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
91747969|NCT00450294|183388003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
91747970|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.136||0.499|TWO_SIDED|95.0|-0.36|0.18|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||0.18|-0.36|0.4990
91747971|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.135|<|0.0001|TWO_SIDED|95.0|-0.83|-0.29|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||-0.29|-0.83|<0.0001
91747972|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|-1.1|-0.56|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference is calculated as Test value minus Negative Control value.|Change from Baseline at Day 3||-0.56|-1.10|<0.0001
91747973|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.112||0.009|TWO_SIDED|95.0|-0.52|-0.08|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||-0.08|-0.52|0.0090
91747974|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-0.89|-0.45|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||-0.45|-0.89|<0.0001
91747975|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-1.66|-1.22|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 14||-1.22|-1.66|<0.0001
91747976|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.116||0.0007|TWO_SIDED|95.0|-0.63|-0.17|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||-0.17|-0.63|0.0007
91747977|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.85|-0.39|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||-0.39|-0.85|<0.0001
91747978|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.85|-1.38|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 28||-1.38|-1.85|<0.0001
91747979|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.112||0.0015|TWO_SIDED|95.0|-0.59|-0.14|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||-0.14|-0.59|0.0015
91747980|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.05|-0.61|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||-0.61|-1.05|<0.0001
91503497|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.04||||0.6924|TWO_SIDED|80.0|-3.72|1.63|||Mixed Models Analysis|||Change from baseline at Day 57||1.63|-3.72|0.6924
91503498|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.61||||0.616|TWO_SIDED|80.0|-3.26|2.04|||Mixed Models Analysis|||Change from baseline at Day 57||2.04|-3.26|0.6160
91503499|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.44||||0.4149|TWO_SIDED|80.0|-2.18|3.06|||Mixed Models Analysis|||Change from baseline at Day 57||3.06|-2.18|0.4149
91503500|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2582|TWO_SIDED|80.0|-1.27|3.85|||Mixed Models Analysis|||Change from baseline at Day 85||3.85|-1.27|0.2582
91503501|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.81||||0.3402|TWO_SIDED|80.0|-1.72|3.34|||Mixed Models Analysis|||Change from baseline at Day 85||3.34|-1.72|0.3402
91503502|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.48||||0.5976|TWO_SIDED|80.0|-2.99|2.03|||Mixed Models Analysis|||Change from baseline at Day 85||2.03|-2.99|0.5976
91503503|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.5||||0.5916|TWO_SIDED|80.0|-3.3|2.29|||Mixed Models Analysis|||Change from baseline at Day 113||2.29|-3.30|0.5916
91503504|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5564|TWO_SIDED|80.0|-3.05|2.45|||Mixed Models Analysis|||Change from baseline at Day 113||2.45|-3.05|0.5564
91747981|NCT05243745|183388023|SUPERIORITY||Adjusted Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.95|-1.49|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 56||-1.49|-1.95|<0.0001
91747982|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|5.93|STANDARD_ERROR_OF_MEAN|2.572||0.0231|TWO_SIDED|95.0|0.83|11.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||11.02|0.83|0.0231
91747983|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|18.42|STANDARD_ERROR_OF_MEAN|2.549|<|0.0001|TWO_SIDED|95.0|13.37|23.47|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||23.47|13.37|<0.0001
91747984|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|23.93|STANDARD_ERROR_OF_MEAN|2.571|<|0.0001|TWO_SIDED|95.0|18.83|29.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 3||29.02|18.83|<0.0001
91747985|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|8.97|STANDARD_ERROR_OF_MEAN|2.293||0.0002|TWO_SIDED|95.0|4.43|13.51|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||13.51|4.43|0.0002
91747986|NCT05243745|183388024|SUPERIORITY||Slope|17.71|STANDARD_ERROR_OF_MEAN|2.265|<|0.0001|TWO_SIDED|95.0|13.22|22.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||22.20|13.22|<0.0001
91503505|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.2||||0.4625|TWO_SIDED|80.0|-2.53|2.93|||Mixed Models Analysis|||Change from baseline at Day 113||2.93|-2.53|0.4625
91747987|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|32.81|STANDARD_ERROR_OF_MEAN|2.288|<|0.0001|TWO_SIDED|95.0|28.27|37.34|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 14||37.34|28.27|<0.0001
91747988|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|10.2|STANDARD_ERROR_OF_MEAN|2.485|<|0.0001|TWO_SIDED|95.0|5.28|15.13|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||15.13|5.28|<0.0001
91747989|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|13.92|STANDARD_ERROR_OF_MEAN|2.46|<|0.0001|TWO_SIDED|95.0|9.05|18.8|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||18.80|9.05|<0.0001
91747990|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|36.51|STANDARD_ERROR_OF_MEAN|2.568|<|0.0001|TWO_SIDED|95.0|31.42|41.6|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 28||41.60|31.42|<0.0001
91747991|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|9.73|STANDARD_ERROR_OF_MEAN|2.761||0.0006|TWO_SIDED|95.0|4.26|15.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||15.20|4.26|0.0006
91747992|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|19.06|STANDARD_ERROR_OF_MEAN|2.772|<|0.0001|TWO_SIDED|95.0|13.57|24.55|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||24.55|13.57|<0.0001
91747993|NCT05243745|183388024|SUPERIORITY||Adjusted Mean Difference|39.33|STANDARD_ERROR_OF_MEAN|2.829|<|0.0001|TWO_SIDED|95.0|33.73|44.94|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 56||44.94|33.73|<0.0001
91747994|NCT02998203|183388034|OTHER|One-sample t-test|||||<|0.001|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||<0.001
91747995|NCT02998203|183388035|OTHER|non-parametric Wilcoxon rank sum test|||||<|0.001|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||<0.001
91747996|NCT02998203|183388036|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||<0.001
91747997|NCT02998203|183388037|OTHER|Wilcoxon rank sum test||||||0.017|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.017
91747998|NCT02998203|183388038|OTHER|Logistic mixed-effect model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
91747999|NCT02998203|183388039|OTHER|One-sample t-test||||||0.167|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.167
91748000|NCT02998203|183388040|OTHER|Wilcoxon rank sum test||||||0.07|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.07
91748001|NCT02998203|183388041|OTHER|Linear mixed-effect regression model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
91748002|NCT02998203|183388042|OTHER|One-sample t-test||||||0.023|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.023
91748003|NCT02998203|183388043|OTHER|Wilcoxon rank sum test||||||0.259|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.259
91748004|NCT02998203|183388044|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=\<0.001.||||<0.001
91748005|NCT02998203|183388045|OTHER|One-sample t-test||||||0.913|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.913
91748006|NCT02998203|183388046|OTHER|Wilcoxon rank sum test||||||0.338|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.338
91748007|NCT02998203|183388047|OTHER|Linear mixed-effect regression model||||||0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=0.01.||||0.001
91503506|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8221|TWO_SIDED|80.0|-4.64|0.76|||Mixed Models Analysis|||Change from baseline at Day 141||0.76|-4.64|0.8221
91503507|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.98||||0.3179|TWO_SIDED|80.0|-1.68|3.64|||Mixed Models Analysis|||Change from baseline at Day 141||3.64|-1.68|0.3179
91503508|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.92||||0.0773|TWO_SIDED|80.0|0.29|5.55|||Mixed Models Analysis|||Change from baseline at Day 141||5.55|0.29|0.0773
91503509|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6708|TWO_SIDED|80.0|-3.71|1.81|||Mixed Models Analysis|||Change from baseline at Day 169||1.81|-3.71|0.6708
91503510|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.99||||0.679|TWO_SIDED|80.0|-3.71|1.74|||Mixed Models Analysis|||Change from baseline at Day 169||1.74|-3.71|0.6790
91503511|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.04||||0.507|TWO_SIDED|80.0|-2.72|2.64|||Mixed Models Analysis|||Change from baseline at Day 169||2.64|-2.72|0.5070
91748008|NCT04187144|183388084|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the 2.098 Z-statistic boundary.|Adjusted Difference in Percent|14.6|||||TWO_SIDED|95.0|6.4|22.8|||||||Observed Z statistic value for Noninferiority was 5.8838.|22.8|6.4|
91503512|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5487|TWO_SIDED|80.0|-3.44|2.84|||Mixed Models Analysis|||Change from baseline at Day 197||2.84|-3.44|0.5487
91503513|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.25||||0.6973|TWO_SIDED|80.0|-4.35|1.85|||Mixed Models Analysis|||Change from baseline at Day 197||1.85|-4.35|0.6973
91503514|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6548|TWO_SIDED|80.0|-4.0|2.11|||Mixed Models Analysis|||Change from baseline at Day 197||2.11|-4.00|0.6548
91748009|NCT04187144|183388084|SUPERIORITY||Adjusted difference in Percent|14.6||||0.0003|TWO_SIDED|95.0|6.4|22.8|||1-sided p-value for Test of Superiority|||The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundary||22.8|6.4|0.0003
91748010|NCT01159171|183388130|SUPERIORITY_OR_OTHER|||||||0.0047||0.0||||One-sided p-value|One sample exact binomial test|||||||0.0047
91748011|NCT01962987|183388142|EQUIVALENCE|90% confidence interval of the difference in the percentage of patients between Test and Reference to be contained within -20%, + 20%, using the Per-Protocol Population.|(Test-Ref) Difference|0.68|||||TWO_SIDED|90.0|-8.06|9.42|||||Applicable to Percentage of Subjects with Cure (100% complete AK clearance at day 90)|||9.42|-8.06|
91748012|NCT01962987|183388142|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.0010
91748013|NCT01468207|183388162|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|15.9|||=|0.003|TWO_SIDED|95.0|5.3|26.5||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||||26.5|5.3|=0.003
91748014|NCT01468207|183388162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8|||=|0.048|TWO_SIDED|95.0|0.3|29.3|||Chi-squared|||||29.3|0.3|=0.048
91748015|NCT01468207|183388162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.1|||=|0.027|TWO_SIDED|95.0|2.2|32.1|||Chi-squared|||||32.1|2.2|=0.027
91748016|NCT01468207|183388163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||=|0.961|TWO_SIDED|95.0|-13.4|14.1|||Chi-squared|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.1|-13.4|=0.961
91748017|NCT01468207|183388164|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|2.8|||=|0.628|TWO_SIDED|95.0|-8.6|14.2||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.2|-8.6|=0.628
91748018|NCT01468207|183388165|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.7|||=|0.124|TWO_SIDED|95.0|-19.7|2.4|||ANCOVA|P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||2.4|-19.7|=0.124
91748019|NCT01328041|183388170|SUPERIORITY_OR_OTHER||T distribution|-1.432|||<|0.001|TWO_SIDED|95.0|-1.52|-1.343||The P value was derived by the null hypothesis testing of no change from Baseline in HIV-1 RNA at Day 8 at the two-sided 5% significance level using a single sample t-test.|t-test, 2 sided|||||-1.343|-1.520|<0.001
91748020|NCT01328041|183388171|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|62.0|76.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 24.|||76|62|
91748021|NCT01328041|183388172|SUPERIORITY_OR_OTHER||percentage of participants|63.0|||||TWO_SIDED|95.0|56.0|70.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 48.|||70|56|
91748022|NCT00664560|183388189|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-4.76|4.32|||ANCOVA|||||4.32|-4.76|
91748023|NCT00664560|183388190|NON_INFERIORITY_OR_EQUIVALENCE|10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-4.57|4.38|||ANCOVA|||||4.38|-4.57|
91748024|NCT00664560|183388191|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-5.08|4.14|||ANCOVA|||||4.14|-5.08|
91748025|NCT03392883|183388201|OTHER|Paired version (T-test for paired sample, Friedman and McNemar tests) was used for contrasting the equality among the variables at different moments of time. In order to adjust our results by potential confounders, ANCOVA analyses was performed. Symmetric 95% confidence intervals will be provided for relevant parameters. All p-values were referred to two-sided hypotheses. P-values below 0.05 were considered statistically significant.|||||<|0.001|TWO_SIDED|95.0||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale. This Statistical Analysis describes the Adoption subscale results.||||<0.001
91748026|NCT03392883|183388201|OTHER|||||||0.552||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Acceptability subscale results.||||0.552
91748027|NCT03392883|183388201|OTHER|||||||0.32||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Appropriateness subscale results.||||0.320
91748028|NCT03392883|183388201|OTHER|||||||0.879||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Feasibility subscale results.||||0.879
91748029|NCT03392883|183388201|OTHER|||||||0.242||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Reach/Access subscale results.||||0.242
91748030|NCT03392883|183388202|OTHER|||||||0.237||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.237
91748031|NCT03392883|183388202|OTHER|||||||0.492||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.492
91748032|NCT03392883|183388202|OTHER|||||||0.285||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.285
91748033|NCT03392883|183388202|OTHER|||||||0.964||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.964
91748034|NCT03392883|183388202|OTHER|||||||0.942||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results.||||0.942
91748035|NCT03392883|183388202|OTHER|||||||0.366||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results.||||0.366
91748036|NCT03392883|183388202|OTHER|||||||0.021||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.021
91748037|NCT03392883|183388202|OTHER|||||||0.832||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.832
91748038|NCT03392883|183388202|OTHER|||||||0.827||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.827
91748039|NCT03392883|183388203|OTHER|||||||0.118||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.118
91503515|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.35||||0.5533|TWO_SIDED|80.0|-3.76|3.05|||Mixed Models Analysis|||Change from baseline at Day 225||3.05|-3.76|0.5533
91503516|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3358|TWO_SIDED|80.0|-2.25|4.46|||Mixed Models Analysis|||Change from baseline at Day 225||4.46|-2.25|0.3358
91503517|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.46||||0.285|TWO_SIDED|80.0|-1.85|4.77|||Mixed Models Analysis|||Change from baseline at Day 225||4.77|-1.85|0.2850
91503518|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.55||||0.5778|TWO_SIDED|80.0|-4.14|3.04|||Mixed Models Analysis|||Change from baseline at Day 253||3.04|-4.14|0.5778
91503519|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.3||||0.2018|TWO_SIDED|80.0|-1.24|5.85|||Mixed Models Analysis|||Change from baseline at Day 253||5.85|-1.24|0.2018
91748040|NCT03392883|183388203|OTHER|||||||0.896||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.896
91503520|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.85||||0.1457|TWO_SIDED|80.0|-0.62|6.32|||Mixed Models Analysis|||Change from baseline at Day 253||6.32|-0.62|0.1457
91503521|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.56||||0.5758|TWO_SIDED|80.0|-4.29|3.18|||Mixed Models Analysis|||Change from baseline at Day 281||3.18|-4.29|0.5758
91503522|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.85||||0.3833|TWO_SIDED|80.0|-2.84|4.55|||Mixed Models Analysis|||Change from baseline at Day 281||4.55|-2.84|0.3833
91531710|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
91503523|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.41||||0.3083|TWO_SIDED|80.0|-2.21|5.02|||Mixed Models Analysis|||Change from baseline at Day 281||5.02|-2.21|0.3083
91748041|NCT03392883|183388203|OTHER|||||||0.739||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.739
91748042|NCT03392883|183388203|OTHER|||||||0.724||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.724
91748043|NCT03392883|183388203|OTHER|||||||0.301||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.301
91748044|NCT03392883|183388203|OTHER|||||||0.034||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.034
91503524|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.54||||0.7063|TWO_SIDED|80.0|-5.19|2.11|||Mixed Models Analysis|||Change from baseline at Day 309||2.11|-5.19|0.7063
91748045|NCT03392883|183388203|OTHER|||||||0.015||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.015
91748046|NCT03392883|183388203|OTHER|||||||0.081||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.081
91748047|NCT03392883|183388203|OTHER|||||||0.79||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results.||||0.790
91748048|NCT03392883|183388204|OTHER|||||||0.023||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time.||||0.023
91503525|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.14||||0.2227|TWO_SIDED|80.0|-1.46|5.74|||Mixed Models Analysis|||Change from baseline at Day 309||5.74|-1.46|0.2227
91503526|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0907|TWO_SIDED|80.0|0.15|7.21|||Mixed Models Analysis|||Change from baseline at Day 309||7.21|0.15|0.0907
91503527|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.17||||0.4799|TWO_SIDED|80.0|-4.23|4.57|||Mixed Models Analysis|||Change from baseline at Day 337||4.57|-4.23|0.4799
91503528|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.2||||0.5237|TWO_SIDED|80.0|-4.54|4.14|||Mixed Models Analysis|||Change from baseline at Day 337||4.14|-4.54|0.5237
91748049|NCT03392883|183388205|OTHER|||||||0.589||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time in this data.||||0.589
91748050|NCT03392883|183388206|OTHER||Mean Difference (Net)|-6.65|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
91748051|NCT03392883|183388207|OTHER||Mean Difference (Net)|-4.48|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the total scores (sum of 12 items) at baseline assessment and at 12-month follow-up assessment.||||
91748052|NCT03392883|183388208|OTHER||Mean Difference (Net)|-5.77|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
91748053|NCT03392883|183388209|OTHER||Mean Difference (Net)|-2.59|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the number of standard drinks per week at baseline assessment and at 12-month follow-up assessment.||||
91748054|NCT02688088|183388236|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.965|1.06||||||||1.06|0.965|
91748055|NCT02688088|183388237|SUPERIORITY||Ratio of Geometric LS Means|0.935|||||TWO_SIDED|90.0|0.871|1.0||||||||1.00|0.871|
91748056|NCT02688088|183388238|SUPERIORITY||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.898|1.22||||||||1.22|0.898|
91748057|NCT02688088|183388239|SUPERIORITY||Ratio of Geometric LS Means|0.845|||||TWO_SIDED|90.0|0.76|0.94||||||||0.940|0.760|
91748058|NCT02688088|183388240|SUPERIORITY||Ratio of Geometric LS Means|1.56|||||TWO_SIDED|90.0|1.35|1.81||||||||1.81|1.35|
91748059|NCT02688088|183388241|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.956|1.13||||||||1.13|0.956|
91748060|NCT02688088|183388242|SUPERIORITY||Mean Difference (Final Values)|0.976|||||TWO_SIDED|90.0|0.805|1.18||||||||1.18|0.805|
91748061|NCT02688088|183388243|SUPERIORITY||Ratio of Geometric LS Means|0.867|||||TWO_SIDED|90.0|0.775|0.972||||||||0.972|0.775|
91748062|NCT01973387|183388265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.178|||<|0.0001|TWO_SIDED|95.0|0.109|0.291|||Log Rank|||||0.291|0.109|<0.0001
91748063|NCT03709277|183388340|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91748064|NCT03709277|183388341|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91748065|NCT03709277|183388343|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91748066|NCT03655301|183388385|OTHER||Least squares mean|0.9405|||||TWO_SIDED|90.0|0.8093|1.0931||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of Cmax||1.0931|0.8093|
91748067|NCT03655301|183388386|OTHER||Least squares mean|1.1205|||||TWO_SIDED|90.0|1.0|1.2555||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC(0-24)||1.2555|1.0000|
91748068|NCT03655301|183388387|OTHER||Least squares mean|1.1147|||||TWO_SIDED|90.0|0.9772|1.2714||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC||1.2714|0.9772|
91748069|NCT02118766|183388401|SUPERIORITY_OR_OTHER|||||||0.038|||||||Regression, Logistic|||||||0.038
91748070|NCT02488135|183388410|NON_INFERIORITY|An a priori sample size was calculated using a non-inferiority limit (d) set at 25%, significance level (α) of 5% and power of 80%. We assumed that success in each group would be 93% based on the literature examining anterior nasal packing in ideal conditions and considering our selection criteria in the Floseal® (Baxter, USA) population. Attrition was assumed to be 0% due to the short duration of treatment. This yielded 26 participants with 13 patients in each study arm.||||||1|||||||Fisher Exact|||||||1.000
91748071|NCT02488135|183388411|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during placement.||||0.0022
91748072|NCT02488135|183388411|SUPERIORITY|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during treatment.||||0.0007
91748073|NCT02488135|183388411|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||Comparison between scores for pain during removal.||||0.0021
91748074|NCT02248649|183388412|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|covariates: baseline age and years of education||||||0.2
91748075|NCT02248649|183388413|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
91748076|NCT02248649|183388414|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
91748077|NCT04621240|183388419|SUPERIORITY|Mean level change from pre- to post-testing|Mean Difference (Net)|10.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91748078|NCT04621240|183388419|OTHER|Regression of the change in BrainHealth Index on age|Slope|0.03||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
91748079|NCT01457014|183388450|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|p values have undergone Bonferroni adjustment for Central Apnea Index (CAI), Obstructive Apnea Index (OAI) and Hypopnea Index (HI)||||||<0.001
91503529|NCT02515942|182878555|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.37||||0.5451|TWO_SIDED|80.0|-4.62|3.87|||Mixed Models Analysis|||Change from baseline at Day 337||3.87|-4.62|0.5451
91503530|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.15||||0.4609|TWO_SIDED|80.0|-1.79|2.09|||Mixed Models Analysis|||Change from baseline at Day 2||2.09|-1.79|0.4609
91503531|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.3771|TWO_SIDED|80.0|-1.44|2.37|||Mixed Models Analysis|||Change from baseline at Day 2||2.37|-1.44|0.3771
91503532|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.32||||0.4161|TWO_SIDED|80.0|-1.6|2.24|||Mixed Models Analysis|||Change from baseline at Day 2||2.24|-1.60|0.4161
91503533|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.88||||0.9385|TWO_SIDED|80.0|-5.26|-0.49|||Mixed Models Analysis|||Change from baseline at Day 29||-0.49|-5.26|0.9385
91503534|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.4||||0.5862|TWO_SIDED|80.0|-2.76|1.96|||Mixed Models Analysis|||Change from baseline at Day 29||1.96|-2.76|0.5862
91503535|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.48||||0.0875|TWO_SIDED|80.0|0.14|4.82|||Mixed Models Analysis|||Change from baseline at Day 29||4.82|0.14|0.0875
91503536|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.53||||0.4059|TWO_SIDED|80.0|-2.32|3.37|||Mixed Models Analysis|||Change from baseline at Day 57||3.37|-2.32|0.4059
91503537|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.24||||0.286|TWO_SIDED|80.0|-1.58|4.05|||Mixed Models Analysis|||Change from baseline at Day 57||4.05|-1.58|0.2860
91503538|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.71||||0.3727|TWO_SIDED|80.0|-2.1|3.52|||Mixed Models Analysis|||Change from baseline at Day 57||3.52|-2.10|0.3727
91503539|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.91||||0.336|TWO_SIDED|80.0|-1.85|3.66|||Mixed Models Analysis|||Change from baseline at Day 85||3.66|-1.85|0.3360
91503540|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.95||||0.0316|TWO_SIDED|80.0|1.24|6.66|||Mixed Models Analysis|||Change from baseline at Day 85||6.66|1.24|0.0316
91748080|NCT01457014|183388451|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED|||||p value has undergone Bonferroni adjustment. P-Value applies to Av. 02 saturation|Wilcoxon (Mann-Whitney)|p value has undergone Bonferroni adjustment||||||0.627
91748081|NCT01457014|183388452|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.161
91748082|NCT03319953|183388457|SUPERIORITY|||||||0.2079||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.2079
91503541|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.04||||0.0762|TWO_SIDED|80.0|0.32|5.76|||Mixed Models Analysis|||Change from baseline at Day 85||5.76|0.32|0.0762
91503542|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0544|TWO_SIDED|80.0|0.75|6.61|||Mixed Models Analysis|||Change from baseline at Day 113||6.61|0.75|0.0544
91748083|NCT03319953|183388457|SUPERIORITY|||||||0.0633||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.0633
91748084|NCT03319953|183388458|SUPERIORITY|||||||0.1706||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.1706
91748085|NCT03319953|183388458|SUPERIORITY|||||||0.0373||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.0373
91503543|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.91||||0.1955|TWO_SIDED|80.0|-0.95|4.77|||Mixed Models Analysis|||Change from baseline at Day 113||4.77|-0.95|0.1955
91503544|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.77||||0.7844|TWO_SIDED|80.0|-4.65|1.12|||Mixed Models Analysis|||Change from baseline at Day 113||1.12|-4.65|0.7844
91503545|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.49||||0.2973|TWO_SIDED|80.0|-2.11|5.08|||Mixed Models Analysis|||Change from baseline at Day 141||5.08|-2.11|0.2973
91503546|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.33||||0.3127|TWO_SIDED|80.0|-2.18|4.84|||Mixed Models Analysis|||Change from baseline at Day 141||4.84|-2.18|0.3127
91748086|NCT02226198|183388500|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
91503547|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.16||||0.5227|TWO_SIDED|80.0|-3.67|3.36|||Mixed Models Analysis|||Change from baseline at Day 141||3.36|-3.67|0.5227
91503548|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.63||||0.7643|TWO_SIDED|80.0|-4.54|1.28|||Mixed Models Analysis|||Change from baseline at Day 169||1.28|-4.54|0.7643
91503549|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.38||||0.7331|TWO_SIDED|80.0|-4.25|1.48|||Mixed Models Analysis|||Change from baseline at Day 169||1.48|-4.25|0.7331
91503550|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.25||||0.4557|TWO_SIDED|80.0|-2.59|3.09|||Mixed Models Analysis|||Change from baseline at Day 169||3.09|-2.59|0.4557
91503551|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.29||||0.4549|TWO_SIDED|80.0|-2.97|3.55|||Mixed Models Analysis|||Change from baseline at Day 197||3.55|-2.97|0.4549
91503552|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.93||||0.3535|TWO_SIDED|80.0|-2.26|4.13|||Mixed Models Analysis|||Change from baseline at Day 197||4.13|-2.26|0.3535
91503553|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.65||||0.397|TWO_SIDED|80.0|-2.54|3.84|||Mixed Models Analysis|||Change from baseline at Day 197||3.84|-2.54|0.3970
91503554|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.78||||0.2714|TWO_SIDED|80.0|-1.99|5.55|||Mixed Models Analysis|||Change from baseline at Day 225||5.55|-1.99|0.2714
91503555|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.72||||0.2741|TWO_SIDED|80.0|-1.97|5.41|||Mixed Models Analysis|||Change from baseline at Day 225||5.41|-1.97|0.2741
91503556|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.06||||0.5084|TWO_SIDED|80.0|-3.74|3.62|||Mixed Models Analysis|||Change from baseline at Day 225||3.62|-3.74|0.5084
91531711|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
91503557|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.82||||0.1537|TWO_SIDED|80.0|-0.73|6.37|||Mixed Models Analysis|||Change from baseline at Day 253||6.37|-0.73|0.1537
91503558|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.79||||0.2542|TWO_SIDED|80.0|-1.69|5.27|||Mixed Models Analysis|||Change from baseline at Day 253||5.27|-1.69|0.2542
91503559|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.03||||0.6504|TWO_SIDED|80.0|-4.46|2.4|||Mixed Models Analysis|||Change from baseline at Day 253||2.40|-4.46|0.6504
91503560|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.3||||0.3405|TWO_SIDED|80.0|-2.78|5.38|||Mixed Models Analysis|||Change from baseline at Day 281||5.38|-2.78|0.3405
91503561|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.41||||0.2194|TWO_SIDED|80.0|-1.59|6.42|||Mixed Models Analysis|||Change from baseline at Day 281||6.42|-1.59|0.2194
91503562|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3596|TWO_SIDED|80.0|-2.87|5.09|||Mixed Models Analysis|||Change from baseline at Day 281||5.09|-2.87|0.3596
91503563|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.07||||0.5086|TWO_SIDED|80.0|-4.04|3.9|||Mixed Models Analysis|||Change from baseline at Day 309||3.90|-4.04|0.5086
91503564|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.33||||0.2211|TWO_SIDED|80.0|-1.57|6.23|||Mixed Models Analysis|||Change from baseline at Day 309||6.23|-1.57|0.2211
91503565|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.4||||0.2126|TWO_SIDED|80.0|-1.47|6.26|||Mixed Models Analysis|||Change from baseline at Day 309||6.26|-1.47|0.2126
91531712|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
91531713|NCT02886728|182939614|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
91531714|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|13.1|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||24.4|13.1|<0.001
91748087|NCT02226198|183388501|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
91748088|NCT02226198|183388502|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
91503566|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.56||||0.2053|TWO_SIDED|80.0|-1.44|6.55|||Mixed Models Analysis|||Change from baseline at Day 337||6.55|-1.44|0.2053
91503567|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.2||||0.2353|TWO_SIDED|80.0|-1.72|6.12|||Mixed Models Analysis|||Change from baseline at Day 337||6.12|-1.72|0.2353
91503568|NCT02515942|182878556|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.36||||0.5471|TWO_SIDED|80.0|-4.24|3.53|||Mixed Models Analysis|||Change from baseline at Day 337||3.53|-4.24|0.5471
91748089|NCT02226198|183388503|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
91503569|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.74||||0.0913|TWO_SIDED|80.0|-5.38|-0.11|||Mixed Models Analysis|||Change from baseline at Day 2||-0.11|-5.38|0.0913
91531715|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.6|4.7|<0.001
91748090|NCT02226198|183388504|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
91531716|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|12.5|27.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.3|12.5|<0.001
91748091|NCT02226198|183388505|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
91748092|NCT02226198|183388506|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
91748093|NCT02226198|183388507|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
91748094|NCT02226198|183388508|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
91531717|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|27.2|||<|0.001|TWO_SIDED|95.0|20.5|33.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||33.9|20.5|<0.001
91531718|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|21.6|||<|0.001|TWO_SIDED|95.0|13.2|30.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||30.1|13.2|<0.001
91748095|NCT02226198|183388509|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
91748096|NCT02226198|183388510|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
91748097|NCT02226198|183388511|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
91748098|NCT02226198|183388522|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
91748099|NCT02226198|183388523|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
91748100|NCT02226198|183388524|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-27.6||||0.006|TWO_SIDED|95.0|-41.2|-11.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.0|-41.2|0.006
91503570|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.28||||0.4454|TWO_SIDED|80.0|-2.89|2.33|||Mixed Models Analysis|||Change from baseline at Day 2||2.33|-2.89|0.4454
91531719|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|19.5|||<|0.001|TWO_SIDED|95.0|11.1|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||27.9|11.1|<0.001
91531720|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|15.8|29.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||29.4|15.8|<0.001
91531721|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|8.1|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||25.2|8.1|<0.001
91531722|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|5.3|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.4|5.3|<0.001
91531723|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|21.4|||<|0.001|TWO_SIDED|95.0|14.6|28.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.2|14.6|<0.001
91531724|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|12.3||||0.003|TWO_SIDED|95.0|3.7|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.9|3.7|0.003
91531725|NCT02886728|182939615|SUPERIORITY||Difference in Response Rates|18.1|||<|0.001|TWO_SIDED|95.0|9.7|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||26.5|9.7|<0.001
91531726|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|6.3|||<|0.001|TWO_SIDED|95.0|3.4|9.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||9.1|3.4|<0.001
91531727|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|3.4||||0.01|TWO_SIDED|95.0|0.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||6.7|0.1|0.010
91531728|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|9.0|||<|0.001|TWO_SIDED|95.0|4.5|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||13.6|4.5|<0.001
91531729|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.4|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||16.1|7.4|<0.001
91531730|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|4.5|<0.001
91531731|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|8.6|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||20.8|8.6|<0.001
91531732|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|16.4|28.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||28.8|16.4|<0.001
91531733|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|14.8|||<|0.001|TWO_SIDED|95.0|7.1|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||22.5|7.1|<0.001
91531734|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|12.5|||<|0.001|TWO_SIDED|95.0|4.9|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.0|4.9|<0.001
91748101|NCT02226198|183388525|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-25.6||||0.005|TWO_SIDED|95.0|-38.1|-10.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.5|-38.1|0.005
91503571|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8861|TWO_SIDED|80.0|-0.16|5.08|||Mixed Models Analysis|||Change from baseline at Day 2||5.08|-0.16|0.8861
91503572|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.16||||0.713|TWO_SIDED|80.0|-1.49|3.8|||Mixed Models Analysis|||Change from baseline at Day 29||3.80|-1.49|0.7130
91531735|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|18.3|||<|0.001|TWO_SIDED|95.0|11.4|25.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||25.1|11.4|<0.001
91748102|NCT02226198|183388526|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-28.2||||0.005|TWO_SIDED|95.0|-41.7|-11.4||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.4|-41.7|0.005
91748103|NCT02226198|183388527|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.4||||0.013|TWO_SIDED|95.0|-32.8|-5.6||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-5.6|-32.8|0.013
91748104|NCT03895632|183388532|OTHER|A linear mixed-effects model was fit to assess the association between α (the slope of the Power Spectral Density (PSD) plot) and signal segment.|||||<|0.0001||||||p-value obtained form the Wald statistics of the linear mixed-effects model. The threshold for statistical signifiance was p=0.01.|Linear mixed-effects model|||The null hypothesis was that α (the slope of the Power Spectral Density (PSD) plot) is not related to signal segment (off-, approaching- and on-target).||||<0.0001
91748105|NCT04545047|183388537|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.3|3.6||||||The investigators estimated the 30-day mortality risk difference comparing patients assigned to each group. Adjustment for covariates would be carried out via inverse probability weighting.||3.60|-2.30|
91748106|NCT04545047|183388537|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.64|1.62||||||The investigators estimated the 30-day mortality hazard ratio comparing patients assigned to each group. The hazard ratio was estimated from pooled logistic models with inverse probability weighting to adjust for confounding.||1.62|0.64|
91748107|NCT01288612|183388540|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Chi-squared|||||||0.25
91748108|NCT01288612|183388540|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
91748109|NCT01288612|183388540|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
91748110|NCT01288612|183388540|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Chi-squared|||||||0.82
91748111|NCT01288612|183388541|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Kruskal-Wallis|||||||0.06
91748112|NCT01288612|183388542|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher Exact|||||||0.08
91748113|NCT01288612|183388543|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
91748114|NCT01288612|183388544|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91748115|NCT01288612|183388545|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
91748116|NCT01288612|183388546|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for pain scale||||<0.001
91748117|NCT01288612|183388546|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for choking scale||||<0.001
91748118|NCT01288612|183388546|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for gagging scale||||<0.001
91748119|NCT01288612|183388546|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for anxiety scale||||<0.001
91748120|NCT01288612|183388546|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between arms for overall tolerance scale||||<0.001
91748121|NCT01288612|183388547|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
91748122|NCT03571672|183388569|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.08|STANDARD_DEVIATION|5.98||0.868|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.868
91748123|NCT03571672|183388569|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.23|STANDARD_DEVIATION|5.445||0.606|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.606
91748124|NCT03571672|183388569|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|4.212||0.224|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.224
91748125|NCT03571672|183388570|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|6.682||0.715|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.715
91503573|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.37||||0.8759|TWO_SIDED|80.0|-0.26|5.01|||Mixed Models Analysis|||Change from baseline at Day 29||5.01|-0.26|0.8759
91748126|NCT03571672|183388570|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.526||0.956|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.956
91748127|NCT03571672|183388570|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|4.584||0.771|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.771
91748128|NCT03571672|183388571|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.944|0.97||||||Inter-Reader Variability Echo Enhanced||0.970|0.944|
91748129|NCT03571672|183388571|OTHER||Intra-class Correlation Coefficient|0.95|||||TWO_SIDED|95.0|0.931|0.964||||||Inter-Reader Variability Echo Unenhanced||0.964|0.931|
91503574|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.22||||0.7256|TWO_SIDED|80.0|-1.39|3.82|||Mixed Models Analysis|||Change from baseline at Day 29||3.82|-1.39|0.7256
91503575|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.17||||0.3111|TWO_SIDED|80.0|-4.22|1.88|||Mixed Models Analysis|||Change from baseline at Day 57||1.88|-4.22|0.3111
91503576|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.7||||0.236|TWO_SIDED|80.0|-4.73|1.34|||Mixed Models Analysis|||Change from baseline at Day 57||1.34|-4.73|0.2360
91503577|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.53||||0.411|TWO_SIDED|80.0|-3.55|2.49|||Mixed Models Analysis|||Change from baseline at Day 57||2.49|-3.55|0.4110
91503578|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.13||||0.5247|TWO_SIDED|80.0|-2.57|2.83|||Mixed Models Analysis|||Change from baseline at Day 85||2.83|-2.57|0.5247
91503579|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.37||||0.0534|TWO_SIDED|80.0|-6.04|-0.7|||Mixed Models Analysis|||Change from baseline at Day 85||-0.70|-6.04|0.0534
91503580|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.5||||0.0475|TWO_SIDED|80.0|-6.18|-0.82|||Mixed Models Analysis|||Change from baseline at Day 85||-0.82|-6.18|0.0475
91503581|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.92||||0.0575|TWO_SIDED|80.0|-7.11|-0.74|||Mixed Models Analysis|||Change from baseline at Day 113||-0.74|-7.11|0.0575
91503582|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.16||||0.1876|TWO_SIDED|80.0|-5.29|0.97|||Mixed Models Analysis|||Change from baseline at Day 113||0.97|-5.29|0.1876
91503583|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.76||||0.7644|TWO_SIDED|80.0|-1.38|4.91|||Mixed Models Analysis|||Change from baseline at Day 113||4.91|-1.38|0.7644
91503584|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.85||||0.0838|TWO_SIDED|80.0|-7.42|-0.28|||Mixed Models Analysis|||Change from baseline at Day 141||-0.28|-7.42|0.0838
91503585|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.38||||0.4444|TWO_SIDED|80.0|-3.89|3.13|||Mixed Models Analysis|||Change from baseline at Day 141||3.13|-3.89|0.4444
91503586|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.47||||0.8977|TWO_SIDED|80.0|-0.04|6.97|||Mixed Models Analysis|||Change from baseline at Day 141||6.97|-0.04|0.8977
91531736|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|7.7||||0.056|TWO_SIDED|95.0|-0.8|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||16.1|-0.8|0.056
91531737|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|9.0||||0.023|TWO_SIDED|95.0|0.5|17.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||17.4|0.5|0.023
91503587|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4917|TWO_SIDED|80.0|-2.92|2.82|||Mixed Models Analysis|||Change from baseline at Day 169||2.82|-2.92|0.4917
91531738|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|21.9|||<|0.001|TWO_SIDED|95.0|15.1|28.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.7|15.1|<0.001
91531739|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|11.5||||0.004|TWO_SIDED|95.0|3.1|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.0|3.1|0.004
91748130|NCT03571672|183388571|OTHER||Intra-class Correlation Coefficient|0.957|||||TWO_SIDED|95.0|0.941|0.969||||||Inter-Reader Variability Echo Enhanced||0.969|0.941|
91748131|NCT03571672|183388571|OTHER||Intra-class Correlation Coefficient|0.934|||||TWO_SIDED|95.0|0.909|0.952||||||Inter-Reader Variability Echo Unenhanced||0.952|0.909|
91748132|NCT03571672|183388571|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.946|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.946|
91748133|NCT03571672|183388571|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.913|0.954||||||Inter-Reader Variability Echo Unenhanced||0.954|0.913|
91748134|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.988|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Diastolic Echo Enhanced||0.992|0.984|
91531740|NCT02886728|182939616|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.3|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.1|6.3|<0.001
91748135|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.986|||||TWO_SIDED|95.0|0.981|0.99||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.990|0.981|
91748136|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.96|||||TWO_SIDED|95.0|0.945|0.971||||||Inter-reader Variability End Diastolic Echo Enhanced||0.971|0.945|
91748137|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.925|||||TWO_SIDED|95.0|0.897|0.945||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.945|0.897|
91748138|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-reader Variability End Diastolic Echo Enhanced||0.978|0.958|
91748139|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.909|||||TWO_SIDED|95.0|0.876|0.934||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.934|0.876|
91748140|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Systolic Echo Enhanced||0.992|0.984|
91748141|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.979|0.989||||||Inter-reader Variability End Systolic Echo Unenhanced||0.989|0.979|
91748142|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-reader Variability End Systolic Echo Enhanced||0.980|0.962|
91748143|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.927|0.961||||||Inter-reader Variability End Systolic Echo Unenhanced||0.961|0.927|
91748144|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-reader Variability End Systolic Echo Enhanced||0.984|0.969|
91748145|NCT03571672|183388572|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.914|0.954||||||Inter-reader Variability End Systolic Echo Unenhanced||0.954|0.914|
91748146|NCT03571672|183388573|OTHER||Intra-class Correlation Coefficient|0.945|||||TWO_SIDED|95.0|0.909|0.967||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.967|0.909|
91748147|NCT03571672|183388573|OTHER||Intra-class Correlation Coefficient|0.917|||||TWO_SIDED|95.0|0.864|0.95||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.950|0.864|
91748148|NCT03571672|183388573|OTHER||Intra-class Correlation Coefficient|0.939|||||TWO_SIDED|95.0|0.9|0.963||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.963|0.900|
91748149|NCT03571672|183388573|OTHER||Intra-class Correlation Coefficient|0.894|||||TWO_SIDED|95.0|0.827|0.935||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.935|0.827|
91748150|NCT03571672|183388573|OTHER||Intra-class Correlation Coefficient|0.952|||||TWO_SIDED|95.0|0.92|0.971||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.971|0.920|
91748151|NCT03571672|183388573|OTHER||Intra-class Correlation Coefficient|0.9|||||TWO_SIDED|95.0|0.838|0.939||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.939|0.838|
91748152|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.961|0.986||||||Inter-reader Variability End Diastolic Echo Enhanced||0.986|0.961|
91748153|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.974|0.991||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.991|0.974|
91748154|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.933|||||TWO_SIDED|95.0|0.89|0.96||||||Inter-reader Variability End Diastolic Echo Enhanced||0.960|0.890|
91503588|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4909|TWO_SIDED|80.0|-2.89|2.79|||Mixed Models Analysis|||Change from baseline at Day 169||2.79|-2.89|0.4909
91748155|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.857|||||TWO_SIDED|95.0|0.77|0.912||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.912|0.770|
91748156|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.914|0.969||||||Inter-reader Variability End Diastolic Echo Enhanced||0.969|0.914|
91748157|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.824|||||TWO_SIDED|95.0|0.721|0.892||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.892|0.721|
91748158|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.982|||||TWO_SIDED|95.0|0.97|0.989||||||Inter-reader Variability End Systolic Echo Enhanced||0.989|0.970|
91748159|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.974|||||TWO_SIDED|95.0|0.957|0.985||||||Inter-reader Variability End Systolic Echo Unenhanced||0.985|0.957|
91748160|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.915|0.969||||||Inter-reader Variability End Systolic Echo Enhanced||0.969|0.915|
91748161|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.89|||||TWO_SIDED|95.0|0.822|0.933||||||Inter-reader Variability End Systolic Echo Unenhanced||0.933|0.822|
91748162|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.932|0.975||||||Inter-reader Variability End Systolic Echo Enhanced||0.975|0.932|
91748163|NCT03571672|183388574|OTHER||Intra-class Correlation Coefficient|0.872|||||TWO_SIDED|95.0|0.794|0.922||||||Inter-reader Variability End Systolic Echo Unenhanced||0.922|0.794|
91748164|NCT02019108|183388694|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.495|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.5|-1.1|0.495
91748165|NCT02019108|183388694|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.079|TWO_SIDED|95.0|-1.6|0.1||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.1|-1.6|0.079
91748166|NCT02019108|183388695|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.117|TWO_SIDED|95.0|-2.6|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.3|-2.6|0.117
91748167|NCT02019108|183388695|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.133|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.3|-2.5|0.133
91748168|NCT02019108|183388696|SUPERIORITY||Median Difference (Final Values)|-0.14||||0.125|TWO_SIDED|95.0|-0.31|0.04||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks||0.04|-0.31|0.125
91748169|NCT02019108|183388696|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.103|TWO_SIDED|95.0|-0.37|0.03||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks||0.03|-0.37|0.103
91748170|NCT02019108|183388697|SUPERIORITY||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.12||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.12|-0.39|<0.001
91748171|NCT02019108|183388697|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.056|TWO_SIDED|95.0|-0.4|0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.01|-0.40|0.056
91748172|NCT02019108|183388698|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.031|TWO_SIDED|95.0|-0.11|-0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.01|-0.11|0.031
91748173|NCT02019108|183388698|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.058|TWO_SIDED|95.0|-0.12|0.0||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.00|-0.12|0.058
91748174|NCT02019108|183388699|SUPERIORITY||Mean Difference (Final Values)|-9.04|||<|0.001|TWO_SIDED|95.0|-11.22|-6.86||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-6.86|-11.22|<0.001
91503589|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.4992|TWO_SIDED|80.0|-2.82|2.81|||Mixed Models Analysis|||Change from baseline at Day 169||2.81|-2.82|0.4992
91748175|NCT02019108|183388699|SUPERIORITY||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.82|-4.75||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||-4.75|-8.82|<0.001
91748176|NCT02019108|183388700|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.111|TWO_SIDED|95.0|-8.3|0.9||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.9|-8.3|0.111
91503590|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.09||||0.3285|TWO_SIDED|80.0|-4.25|2.07|||Mixed Models Analysis|||Change from baseline at Day 197||2.07|-4.25|0.3285
91503591|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.45||||0.1568|TWO_SIDED|80.0|-5.57|0.67|||Mixed Models Analysis|||Change from baseline at Day 197||0.67|-5.57|0.1568
91503592|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.36||||0.2867|TWO_SIDED|80.0|-4.46|1.74|||Mixed Models Analysis|||Change from baseline at Day 197||1.74|-4.46|0.2867
91503593|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.93||||0.0798|TWO_SIDED|80.0|-7.51|-0.35|||Mixed Models Analysis|||Change from baseline at Day 225||-0.35|-7.51|0.0798
91748177|NCT02019108|183388700|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.232|TWO_SIDED|95.0|-7.3|1.8||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||1.8|-7.3|0.232
91748178|NCT02019108|183388701|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.462|TWO_SIDED|95.0|-0.36|0.78||a priori threshold for significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.78|-0.36|0.462
91748179|NCT02019108|183388701|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.737|TWO_SIDED|95.0|-0.76|0.54||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.54|-0.76|0.737
91748180|NCT02019108|183388702|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.876|TWO_SIDED|95.0|-0.5|0.43||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.43|-0.50|0.876
91748181|NCT02019108|183388702|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.897|TWO_SIDED|95.0|-0.43|0.49||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.49|-0.43|0.897
91748182|NCT02642393|183388709|OTHER||Slope|1.256|STANDARD_ERROR_OF_MEAN|0.943||0.183|TWO_SIDED|95.0|-0.594|3.106|||Mixed Models Analysis|||||3.106|-0.594|0.183
91748183|NCT02642393|183388710|OTHER||Rate Ratio|1.08||||0.124|TWO_SIDED|95.0|0.979|1.192|||Poisson Regression|||||1.192|0.979|0.124
91748184|NCT02642393|183388711|OTHER||Rate Ratio|1.154||||0.004|TWO_SIDED|95.0|1.046|1.273|||Poisson Regression|||||1.273|1.046|0.004
91748185|NCT02642393|183388712|OTHER|||||||0.002|||||||Log Rank|||||||0.002
91748186|NCT02642393|183388713|OTHER|||||||0.497|||||||Log Rank|||||||0.497
91748187|NCT02642393|183388714|OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.385||0.856|TWO_SIDED|95.0|-0.825|0.685|||Mixed Models Analysis|||||0.685|-0.825|0.856
91748188|NCT02642393|183388715|OTHER||Slope|0.076|STANDARD_ERROR_OF_MEAN|0.226||0.736|TWO_SIDED|95.0|-0.368|0.521|||Mixed Models Analysis|||Anxiety||0.521|-0.368|0.736
91748189|NCT02642393|183388715|OTHER||Slope|0.295|STANDARD_ERROR_OF_MEAN|0.213||0.167|TWO_SIDED|95.0|-0.124|0.714|||Mixed Models Analysis|||Cognitive Function||0.714|-0.124|0.167
91748190|NCT02642393|183388715|OTHER||Slope|0.256|STANDARD_ERROR_OF_MEAN|0.111||0.022|TWO_SIDED|95.0|0.038|0.474|||Mixed Models Analysis|||Communication||0.474|0.038|0.022
91748191|NCT02642393|183388715|OTHER||Slope|0.095|STANDARD_ERROR_OF_MEAN|0.173||0.584|TWO_SIDED|95.0|-0.245|0.435|||Mixed Models Analysis|||Emotional and Behavioral Dyscontrol||0.435|-0.245|0.584
91748192|NCT02642393|183388715|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.28||0.973|TWO_SIDED|95.0|-0.56|0.541|||Mixed Models Analysis|||Fatigue||0.541|-0.560|0.973
91748193|NCT02642393|183388715|OTHER||Slope|0.169|STANDARD_ERROR_OF_MEAN|0.136||0.214|TWO_SIDED|95.0|-0.098|0.437|||Mixed Models Analysis|||Lower Extremity Function||0.437|-0.098|0.214
91748194|NCT02642393|183388715|OTHER||Slope|-0.334|STANDARD_ERROR_OF_MEAN|0.304||0.271|TWO_SIDED|95.0|-0.931|0.262|||Mixed Models Analysis|||Positive Affect and Well-Being||0.262|-0.931|0.271
91748195|NCT02642393|183388715|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|95.0|-0.355|0.194|||Mixed Models Analysis|||Stigma||0.194|-0.355|0.566
91748196|NCT02642393|183388715|OTHER||Slope|0.212|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.063|0.487|||Mixed Models Analysis|||Upper Extremity Function||0.487|-0.063|0.130
91748197|NCT02642393|183388715|OTHER||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.202||0.723|TWO_SIDED|95.0|-0.325|0.468|||Mixed Models Analysis|||Sleep Disturbance||0.468|-0.325|0.723
91748198|NCT02642393|183388715|OTHER||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.298||0.984|TWO_SIDED|95.0|-0.592|0.579|||Mixed Models Analysis|||Satisfaction with Social Roles and Activities||0.579|-0.592|0.984
91748199|NCT02642393|183388715|OTHER||Slope|-0.253|STANDARD_ERROR_OF_MEAN|0.317||0.426|TWO_SIDED|95.0|-0.877|0.371|||Mixed Models Analysis|||Participation in Social Roles and Activities||0.371|-0.877|0.426
91748200|NCT02642393|183388716|OTHER||Slope|-0.106|STANDARD_ERROR_OF_MEAN|0.141||0.454|TWO_SIDED|95.0|-0.382|0.171|||Mixed Models Analysis|||||0.171|-0.382|0.454
91748201|NCT02642393|183388717|OTHER||Slope|0.047|STANDARD_ERROR_OF_MEAN|0.413||0.91|TWO_SIDED|95.0|-0.764|0.858|||Mixed Models Analysis|||||0.858|-0.764|0.910
91748202|NCT02642393|183388718|OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.758|TWO_SIDED|95.0|-0.295|0.215|||Mixed Models Analysis|||||0.215|-0.295|0.758
91748203|NCT02642393|183388719|OTHER||Slope|-0.208|STANDARD_ERROR_OF_MEAN|0.803||0.796|TWO_SIDED|95.0|-1.783|1.367|||Mixed Models Analysis|||BL to V01||1.367|-1.783|0.796
91503594|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.47||||0.2962|TWO_SIDED|80.0|-5.0|2.06|||Mixed Models Analysis|||Change from baseline at Day 225||2.06|-5.00|0.2962
91503595|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8163|TWO_SIDED|80.0|-1.05|5.98|||Mixed Models Analysis|||Change from baseline at Day 225||5.98|-1.05|0.8163
91503596|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.64||||0.0708|TWO_SIDED|80.0|-6.81|-0.47|||Mixed Models Analysis|||Change from baseline at Day 253||-0.47|-6.81|0.0708
91503597|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.575|TWO_SIDED|80.0|-2.67|3.59|||Mixed Models Analysis|||Change from baseline at Day 253||3.59|-2.67|0.5750
91503598|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.1||||0.956|TWO_SIDED|80.0|1.03|7.17|||Mixed Models Analysis|||Change from baseline at Day 253||7.17|1.03|0.9560
91503599|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.22||||0.1283|TWO_SIDED|80.0|-6.86|0.42|||Mixed Models Analysis|||Change from baseline at Day 281||0.42|-6.86|0.1283
91503600|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.28||||0.2085|TWO_SIDED|80.0|-5.88|1.33|||Mixed Models Analysis|||Change from baseline at Day 281||1.33|-5.88|0.2085
91503601|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.94||||0.6335|TWO_SIDED|80.0|-2.61|4.49|||Mixed Models Analysis|||Change from baseline at Day 281||4.49|-2.61|0.6335
91531741|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-7.3|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-7.3|<0.001
91748204|NCT02642393|183388719|OTHER||Slope|-2.4|STANDARD_ERROR_OF_MEAN|3.443||0.486|TWO_SIDED|95.0|-9.156|4.355|||Mixed Models Analysis|||V10 to SV||4.355|-9.156|0.486
91748205|NCT00396006|183388739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0195|||||||Wilcoxon signed rank test|||||||0.0195
91748206|NCT00396006|183388743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
91748207|NCT00396006|183388744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
91748208|NCT00396006|183388746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1875|||||||Wilcoxon signed rank test|||||||0.1875
91748209|NCT00396006|183388747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4375|||||||Wilcoxon signed rank|||||||0.4375
91748210|NCT02851797|183388755|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in 4SC at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|generalised least square mean ratio|0.86|||=|0.0345|TWO_SIDED|95.0|0.745|0.989||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|ANCOVA||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|Log transformation applied||0.989|0.745|=0.0345
91748211|NCT02851797|183388756|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in time to rise from the Floor at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 m, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|difference in least square means|-3.28|||=|0.3044|TWO_SIDED|95.0|-9.573|3.018||See comment above|ANCOVA||See comment above|||3.018|-9.573|=0.3044
91503602|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.64||||0.1778|TWO_SIDED|80.0|-6.31|1.03|||Mixed Models Analysis|||Change from baseline at Day 309||1.03|-6.31|0.1778
91748212|NCT02851797|183388757|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in distance walked at the end of the 6-minute walking test (6MWT) at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|9.96|||=|0.3723|TWO_SIDED|95.0|-12.071|31.983||See comment above|ANCOVA|LS means, CIs, p-values were obtained from analysis of covariance model on change from baseline in distance walked at the end of the 6MWT at Month18.|See comment above|||31.983|-12.071|=0.3723
91748213|NCT02851797|183388758|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in total NSAA score at Month 18 with baseline values for: total NSAA score, 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|1.91|||=|0.0209|TWO_SIDED|95.0|0.295|3.533||Same comment as above|ANCOVA||Same comment as above.|||3.533|0.295|=0.0209
91748214|NCT02851797|183388759|SUPERIORITY|Estimated cumulative failures, ratio of cumulative failures, CIs, and p-values are obtained from a negative binomial regression on the subject cumulative number of failures across all post-baseline visits. Total failed items at baseline, baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose were included as independent covariates, with treatment group and steroid use included as indep classification factors.|Ratio of cumulative failures|0.61|||=|0.0202|TWO_SIDED|95.0|0.408|0.927||same comment as above|negative binomial regression model|Estimated cumulative failures, their ratio were obtained from a negative binomial regression on the cumulative N of failures across all visits.|"A lower ratio indicates a greater reduction in cumulative loss of function across 18 months for givinostat compared with placebo.~See also comment above."|||0.927|0.408|=0.0202
91748215|NCT02851797|183388760|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.19|||=|0.0902|TWO_SIDED|95.0|-0.03|0.401||same comment as above|ANCOVA||same comment as above|Overall knee extension||0.401|-0.030|=0.0902
91748216|NCT02851797|183388760|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.09|||=|0.1818|TWO_SIDED|95.0|-0.041|0.213||same comment as above|ANCOVA||same comment as above|Overall elbow flexion||0.213|-0.041|=0.1818
91748217|NCT02851797|183388761|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in VL MFF at Month 18 with baseline VL MFF and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|-2.92|||=|0.0354|TWO_SIDED|95.0|-5.641|-0.204||Same comment as above|ANCOVA||Same comment as above|||-0.204|-5.641|=0.0354
91748218|NCT03077438|183388764|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|7.6|||||TWO_SIDED|95.0|1.1|14.0||||||Serogroup A||14|1.1|
91748219|NCT03077438|183388764|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|47.4|||||TWO_SIDED|95.0|42.2|52.2||||||Serogroup C||52.2|42.2|
91748220|NCT03077438|183388764|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|12.2|||||TWO_SIDED|95.0|7.7|16.7||||||Serogroup Y||16.7|7.7|
91748221|NCT03077438|183388764|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|14.8|||||TWO_SIDED|95.0|8.9|20.5||||||Serogroup W||20.5|8.9|
91748222|NCT03077438|183388765|OTHER||GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32||||||Serogroup A||1.32|0.91|
91748223|NCT03077438|183388765|OTHER||GMT Ratio|14.0|||||TWO_SIDED|95.0|11.3|17.3||||||Serogroup C||17.3|11.3|
91748224|NCT03077438|183388765|OTHER||GMT Ratio|1.58|||||TWO_SIDED|95.0|1.31|1.9||||||Serogroup Y||1.9|1.31|
91748225|NCT03077438|183388765|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.21|1.69||||||Serogroup W||1.69|1.21|
91748226|NCT03077438|183388766|OTHER||GMT Ratio|1.14|||||TWO_SIDED|95.0|0.883|1.47||||||Serogroup A||1.47|0.883|
91748227|NCT03077438|183388766|OTHER||GMT Ratio|17.4|||||TWO_SIDED|95.0|13.4|22.6||||||Serogroup C||22.6|13.4|
91748228|NCT03077438|183388766|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.07|1.78||||||Serogroup Y||1.78|1.07|
91748229|NCT03077438|183388766|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.12|1.83||||||Serogroup W||1.83|1.12|
91748230|NCT03077438|183388767|OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.816|1.38||||||Serogroup A||1.38|0.816|
91748231|NCT03077438|183388767|OTHER||GMT Ratio|11.5|||||TWO_SIDED|95.0|8.24|16.0||||||Serogroup C||16|8.24|
91748232|NCT03077438|183388767|OTHER||GMT Ratio|1.84|||||TWO_SIDED|95.0|1.41|2.38||||||Serogroup Y||2.38|1.41|
91748233|NCT03077438|183388767|OTHER||GMT Ratio|1.45|||||TWO_SIDED|95.0|1.16|1.82||||||Serogroup W||1.82|1.16|
91748234|NCT03077438|183388768|OTHER||Percentage Difference|7.6|||||TWO_SIDED|95.0|-1.6|16.7||||||Serogroup A||16.7|-1.6|
91503603|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.7||||0.4027|TWO_SIDED|80.0|-4.33|2.94|||Mixed Models Analysis|||Change from baseline at Day 309||2.94|-4.33|0.4027
91503604|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.94||||0.757|TWO_SIDED|80.0|-1.64|5.53|||Mixed Models Analysis|||Change from baseline at Day 309||5.53|-1.64|0.7570
91503605|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.9||||0.1132|TWO_SIDED|80.0|-8.03|0.23|||Mixed Models Analysis|||Change from baseline at Day 337||0.23|-8.03|0.1132
91503606|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.71||||0.1965|TWO_SIDED|80.0|-6.8|1.37|||Mixed Models Analysis|||Change from baseline at Day 337||1.37|-6.80|0.1965
91503607|NCT02515942|182878557|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.18||||0.6471|TWO_SIDED|80.0|-2.85|5.21|||Mixed Models Analysis|||Change from baseline at Day 337||5.21|-2.85|0.6471
91503608|NCT05620576|182878566|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.61|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-0.61|
91531742|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-6.4|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-6.4|<0.001
91503609|NCT05620576|182878567|SUPERIORITY||Posterior Mean Difference|0.26|||||TWO_SIDED|95.0|-0.47|0.99|||||Posterior mean difference with 95% credible interval is reported.|||0.99|-0.47|
91503610|NCT05620576|182878568|SUPERIORITY||Posterior Mean Difference|0.33|||||TWO_SIDED|95.0|-0.11|0.78|||||Posterior mean difference with 95% credible interval is reported.|||0.78|-0.11|
91503611|NCT05620576|182878569|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.56|0.96|||||Posterior mean difference with 95% credible interval is reported.|||0.96|-0.56|
91503612|NCT05620576|182878570|SUPERIORITY||Posterior Mean Difference|-0.77|||||TWO_SIDED|95.0|-9.41|7.75|||||Posterior mean difference with 95% credible interval is reported.|||7.75|-9.41|
91531743|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-7.7|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.7|<0.001
91748235|NCT03077438|183388768|OTHER||Percentage Difference|51.1|||||TWO_SIDED|95.0|43.5|57.8||||||Serogroup C||57.8|43.5|
91503613|NCT05620576|182878571|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.51|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.51|
91503614|NCT05620576|182878572|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
91503615|NCT05620576|182878573|SUPERIORITY||Posterior Mean Difference|23.02|||||TWO_SIDED|95.0|-108.05|152.33|||||Posterior mean difference with 95% credible interval is reported.|||152.33|-108.05|
91503616|NCT03616912|182878576|SUPERIORITY||Odds Ratio (OR)|1.57||||0.016|TWO_SIDED|95.0|1.09|2.27|||Regression, Logistic|||||2.27|1.09|0.016
91503617|NCT03616912|182878577|SUPERIORITY||Odds Ratio (OR)|1.14||||0.47|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||||1.65|0.79|0.470
91503618|NCT03616912|182878578|SUPERIORITY||Odds Ratio (OR)|0.96||||0.839|TWO_SIDED|95.0|0.63|1.45|||Regression, Logistic|||||1.45|0.63|0.839
91503619|NCT03616912|182878578|SUPERIORITY||Odds Ratio (OR)|1.19||||0.391|TWO_SIDED|95.0|0.8|1.79|||Regression, Logistic|||||1.79|0.80|0.391
91503620|NCT03616912|182878580|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.53|1.66|||Regression, Logistic|||||1.66|0.53|0.820
91503621|NCT03616912|182878580|SUPERIORITY||Odds Ratio (OR)|1.18||||0.565|TWO_SIDED|95.0|0.67|2.08|||Regression, Logistic|||||2.08|0.67|0.565
91503622|NCT03616912|182878581|SUPERIORITY||LS Mean Difference Final Values|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.598|TWO_SIDED|95.0|-0.52|0.3|||Mixed Models Analysis|||||0.30|-0.52|0.598
91503623|NCT03616912|182878581|SUPERIORITY||LS Mean Difference Final Values|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.674|TWO_SIDED|95.0|-0.5|0.32|||Mixed Models Analysis|||||0.32|-0.50|0.674
91503624|NCT03616912|182878582|SUPERIORITY||LS Mean Difference Final Values|0.02|STANDARD_ERROR_OF_MEAN|0.85||0.979|TWO_SIDED|95.0|-1.65|1.7|||Mixed Models Analysis|||||1.70|-1.65|0.979
91503625|NCT03616912|182878582|SUPERIORITY||LS Mean Difference Final Values|-0.36|STANDARD_ERROR_OF_MEAN|0.86||0.678|TWO_SIDED|95.0|-2.03|1.32|||Mixed Models Analysis|||||1.32|-2.03|0.678
91503626|NCT03616912|182878583|SUPERIORITY||Odds Ratio (OR)|1.02||||0.965|TWO_SIDED|95.0|0.43|2.42|||Regression, Logistic|||||2.42|0.43|0.965
91748236|NCT03077438|183388768|OTHER||Percentage Difference|11.2|||||TWO_SIDED|95.0|4.2|18.1||||||Serogroup Y||18.1|4.2|
91748237|NCT03077438|183388768|OTHER||Percentage Difference|12.5|||||TWO_SIDED|95.0|3.9|20.9||||||Serogroup W||20.9|3.9|
91503627|NCT03616912|182878583|SUPERIORITY||Odds Ratio (OR)|1.22||||0.661|TWO_SIDED|95.0|0.51|2.92|||Regression, Logistic|||||2.92|0.51|0.661
91503628|NCT03616912|182878584|SUPERIORITY||LS Mean Difference Final Values|0.24|STANDARD_ERROR_OF_MEAN|0.43||0.578|TWO_SIDED|95.0|-0.61|1.08|||Mixed Models Analysis|||||1.08|-0.61|0.578
91531744|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.6|-8.9|<0.001
91531745|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
91531746|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.8|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.8|<0.001
91748238|NCT03077438|183388769|OTHER||Percentage Difference|7.7|||||TWO_SIDED|95.0|-1.3|16.6||||||Serogroup A||16.6|-1.3|
91748239|NCT03077438|183388769|OTHER||Percentage Difference|44.0|||||TWO_SIDED|95.0|36.8|50.6||||||Serogroup C||50.6|36.8|
91748240|NCT03077438|183388769|OTHER||Percentage Difference|13.3|||||TWO_SIDED|95.0|7.6|19.2||||||Serogroup Y||19.2|7.6|
91503629|NCT03616912|182878584|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.433||0.309|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||||0.41|-1.29|0.309
91503630|NCT03616912|182878585|SUPERIORITY||LS Mean Difference Final Values|-0.29|STANDARD_ERROR_OF_MEAN|0.277||0.287|TWO_SIDED|95.0|-0.84|0.25|||Mixed Models Analysis|||||0.25|-0.84|0.287
91531747|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|-7.3|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.3|<0.001
91748241|NCT03077438|183388769|OTHER||Percentage Difference|17.2|||||TWO_SIDED|95.0|9.4|24.7||||||Serogroup W||24.7|9.4|
91748242|NCT03622112|183388776|SUPERIORITY||Mean Difference (Final Values)|-0.036||||0.437|TWO_SIDED|95.0|-0.126|0.054|||Mixed Models Analysis|||||0.054|-0.126|0.437
91748243|NCT03622112|183388776|SUPERIORITY||Mean Difference (Final Values)|-0.054||||0.236|TWO_SIDED|95.0|-0.143|0.035|||Mixed Models Analysis|||||0.035|-0.143|0.236
91748244|NCT03622112|183388776|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.389|TWO_SIDED|95.0|-0.05|0.128|||Mixed Models Analysis|||||0.128|-0.050|0.389
91748245|NCT03622112|183388776|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.094|TWO_SIDED|95.0|-0.013|0.165|||Mixed Models Analysis|||||0.165|-0.013|0.094
91748246|NCT03622112|183388776|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.06|TWO_SIDED|95.0|-0.003|0.167|||Mixed Models Analysis|||||0.167|-0.003|0.060
91748247|NCT03622112|183388776|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.014|TWO_SIDED|95.0|0.023|0.199|||Mixed Models Analysis|||||0.199|0.023|0.014
91748248|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.463|TWO_SIDED|95.0|-0.048|0.105|||Mixed Models Analysis|||Week 2||0.105|-0.048|0.463
91503631|NCT03616912|182878585|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.278||0.113|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|||||0.11|-0.99|0.113
91503632|NCT01124604|182878602|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||||95.0|-1.04|0.8|||||Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.|||0.80|-1.04|
91503633|NCT01762943|182878621|SUPERIORITY|||||||0.27|||||||repeated measures ANOVA|F=1.40, df=2,26||||||.27
91503634|NCT01762943|182878622|SUPERIORITY|||||||0.018|||||||repeated measures ANOVA|F=6.29, df=1,28||||||.018
91503635|NCT03090100|182878652|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|14.2|||<|0.001|TWO_SIDED|95.0|9.2|19.2|||z-test|||||19.2|9.2|<0.001
91503636|NCT03090100|182878652|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91503637|NCT03090100|182878653|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|4.3|||<|0.001|TWO_SIDED|95.0|-0.2|8.9|||z-test|||||8.9|-0.2|<0.001
91503638|NCT03090100|182878653|SUPERIORITY|||||||0.062|||||||Cochran-Mantel-Haenszel|||||||0.062
91503639|NCT03090100|182878654|OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-12.2|-1.7||||||||-1.7|-12.2|
91503640|NCT03090100|182878655|OTHER||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-6.0|1.2||||||||1.2|-6.0|
91503641|NCT03090100|182878656|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|3.8|15.5||||||||15.5|3.8|
91503642|NCT03090100|182878657|OTHER||Difference in percentage|11.6|||||TWO_SIDED|95.0|5.8|17.4||||||||17.4|5.8|
91503643|NCT03090100|182878658|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|4.9|14.5||||||||14.5|4.9|
91503644|NCT03090100|182878659|OTHER||Difference in percentage|7.8|||||TWO_SIDED|95.0|2.3|13.2||||||||13.2|2.3|
91503645|NCT03090100|182878660|OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-3.5|3.1||||||||3.1|-3.5|
91503646|NCT03090100|182878661|OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-6.2|3.4||||||||3.4|-6.2|
91503647|NCT03090100|182878662|OTHER||Difference in percentage|9.8|||||TWO_SIDED|95.0|4.2|15.3||||||||15.3|4.2|
91503648|NCT03090100|182878663|OTHER||Difference in percentage|-0.1|||||TWO_SIDED|95.0|-4.2|3.9||||||||3.9|-4.2|
91503649|NCT03090100|182878664|OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-5.0|3.3||||||||3.3|-5.0|
91503650|NCT00456521|182878682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.21|||<|0.001||95.0|-5.56|-2.86|||ANCOVA|||||-2.86|-5.56|<0.001
91503651|NCT00456521|182878683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89|||<|0.001||95.0|2.02|4.13|||Regression, Logistic|||||4.13|2.02|<0.001
91531748|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.1|-2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-6.1|<0.001
91503652|NCT00456521|182878684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|1.95|4.37|||Regression, Logistic|||||4.37|1.95|<0.001
91503653|NCT00456521|182878685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.21|||<|0.001|TWO_SIDED|95.0|-4.82|-1.6|||ANCOVA|||||-1.60|-4.82|<0.001
91503654|NCT00456521|182878686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.11||||0.004|TWO_SIDED||||||ANCOVA|||||||0.004
91503655|NCT00456521|182878687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.53||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
91748249|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.576|TWO_SIDED|95.0|-0.055|0.098|||Mixed Models Analysis|||Week 2||0.098|-0.055|0.576
91748250|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.047|TWO_SIDED|95.0|0.001|0.154|||Mixed Models Analysis|||Week 2||0.154|0.001|0.047
91503656|NCT00456521|182878688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.23|||<|0.001|TWO_SIDED|95.0|1.52|4.95|||ANCOVA|||||4.95|1.52|<0.001
91503657|NCT00456521|182878689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.14||||0.001|TWO_SIDED|95.0|1.23|5.04|||ANCOVA|||||5.04|1.23|0.001
91748251|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.009|TWO_SIDED|95.0|0.025|0.179|||Mixed Models Analysis|||Week 2||0.179|0.025|0.009
91748252|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.006|TWO_SIDED|95.0|0.031|0.178|||Mixed Models Analysis|||Week 2||0.178|0.031|0.006
91748253|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.003|TWO_SIDED|95.0|0.041|0.194|||Mixed Models Analysis|||Week 2||0.194|0.041|0.003
91503658|NCT00456521|182878690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.37||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
91503659|NCT00456521|182878691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.98||||0.165|TWO_SIDED||||||ANCOVA|||||||0.165
91503660|NCT00456521|182878692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.28|||||TWO_SIDED|95.0|-3.34|0.79||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.79|-3.34|
91503661|NCT00456521|182878693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|95.0|-7.26|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-7.26|
91503662|NCT00456521|182878694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|||||TWO_SIDED|95.0|0.97|4.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.14|0.97|
91503663|NCT00456521|182878695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|0.25|2.49||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.49|0.25|
91503664|NCT00456521|182878696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.7|0.87||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.87|-0.70|
91503665|NCT00456521|182878697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.85|0.63||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.63|-0.85|
91503666|NCT00456521|182878698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.78|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.78|
91503667|NCT00456521|182878699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.29|||||TWO_SIDED|95.0|-9.16|-1.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.42|-9.16|
91513390|NCT01047683|182898444|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.5||||0.0019|TWO_SIDED|95.0|-13.5|-3.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-3.2|-13.5|0.0019
91513391|NCT01047683|182898444|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.6||||0.2367|TWO_SIDED|95.0|-7.8|1.9|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||1.9|-7.8|0.2367
91503668|NCT02596854|182878700|NON_INFERIORITY|α=0.025 with a margin of Δ=0.5 were used for non-inferiority testing|Median Difference (Net)|-0.428|STANDARD_ERROR_OF_MEAN|0.3522|<|0.001|TWO_SIDED|95.0|-0.428|-0.269||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)||Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.|Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S \> -Δ.|To mitigate possible bias, the hypothesis test was executed via pre-programmed SAS module, which does not show the data for individual synthetic and conventional group values. The data for these individual groups is thus not currently available as part of the study report held by the sponsor or submitted to FDA. Thus, this data cannot be presented without additional analysis (re-programming) of the original SAS used to perform the study. Data were only reported as the difference between synthetic - conventional to determine non-inferiority, and data for individual crossovers (synthetic vs. conventional) were not calculated.The raw conventional scan images and those post-processed with the research software were combined as pre-specified in the study protocol|-0.269|-0.428|<0.001
91531749|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.8|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-6.8|<0.001
91748254|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.685|TWO_SIDED|95.0|-0.068|0.103|||Mixed Models Analysis|||Week 4||0.103|-0.068|0.685
91503669|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.14|STANDARD_ERROR_OF_MEAN|0.037||0.1351|TWO_SIDED|95.0|0.96|1.35|||ANOVA|||CREM; Placebo vs GSK256066 1 mcg||1.35|0.96|0.1351
91503670|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.037||0.0383|TWO_SIDED|95.0|1.01|1.41|||ANOVA|||CREM; Placebo vs GSK256066 10 mcg||1.41|1.01|0.0383
91503671|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.2|STANDARD_ERROR_OF_MEAN|0.037||0.0325|TWO_SIDED|95.0|1.02|1.43|||ANOVA|||CREM; Placebo vs GSK256066 50 mcg||1.43|1.02|0.0325
91503672|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.42|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|1.2|1.68|||ANOVA|||CREM; Placebo vs GSK256066 200 mcg||1.68|1.20|<0.0001
91503673|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.45|STANDARD_ERROR_OF_MEAN|0.049||0.0015|TWO_SIDED|95.0|1.16|1.82|||ANOVA|||DUSP1; Placebo vs GSK256066 1 mcg||1.82|1.16|0.0015
91503674|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.049||0.0002|TWO_SIDED|95.0|1.24|1.93|||ANOVA|||DUSP1; Placebo vs GSK256066 10 mcg||1.93|1.24|0.0002
91503675|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.38|2.17|||ANOVA|||DUSP1; Placebo vs GSK256066 50 mcg||2.17|1.38|<0.0001
91503676|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.75|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|1.4|2.18|||ANOVA|||DUSP1; Placebo vs GSK256066 200 mcg||2.18|1.40|<0.0001
91503677|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.49|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|1.22|1.81|||ANOVA|||FOSL2; Placebo vs GSK256066 1 mcg||1.81|1.22|0.0001
91503678|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.52|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.25|1.85|||ANOVA|||FOSL2; Placebo vs GSK256066 10 mcg||1.85|1.25|<0.0001
91503679|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.68|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.38|2.05|||ANOVA|||FOSL2; Placebo vs GSK256066 50 mcg||2.05|1.38|<0.0001
91503680|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.28|1.89|||ANOVA|||FOSL2; Placebo vs GSK256066 200 mcg||1.89|1.28|<0.0001
91503681|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.064||0.0034|TWO_SIDED|95.0|1.16|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 1 mcg||2.07|1.16|0.0034
91503682|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.063||0.0029|TWO_SIDED|95.0|1.17|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 10 mcg||2.07|1.17|0.0029
91503683|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.064||0.0003|TWO_SIDED|95.0|1.3|2.33|||ANOVA|||IRS2; Placebo vs GSK256066 50 mcg||2.33|1.30|0.0003
91748255|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.176|TWO_SIDED|95.0|-0.026|0.144|||Mixed Models Analysis|||Week 4||0.144|-0.026|0.176
91748256|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.024|TWO_SIDED|95.0|0.013|0.183|||Mixed Models Analysis|||Week 4||0.183|0.013|0.024
91748257|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.014|TWO_SIDED|95.0|0.021|0.191|||Mixed Models Analysis|||Week 4||0.191|0.021|0.014
91748258|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.006|TWO_SIDED|95.0|0.032|0.196|||Mixed Models Analysis|||Week 4||0.196|0.032|0.006
91748259|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.081|0.249|||Mixed Models Analysis|||Week 4||0.249|0.081|< 0.001
91503684|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.56|STANDARD_ERROR_OF_MEAN|0.063||0.0027|TWO_SIDED|95.0|1.17|2.08|||ANOVA|||IRS2; Placebo vs GSK256066 200 mcg||2.08|1.17|0.0027
91503685|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.54|STANDARD_ERROR_OF_MEAN|0.092||0.0448|TWO_SIDED|95.0|1.01|2.34|||ANOVA|||NR4A2; Placebo vs GSK256066 1 mcg||2.34|1.01|0.0448
91503686|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.87|STANDARD_ERROR_OF_MEAN|0.091||0.0033|TWO_SIDED|95.0|1.24|2.83|||ANOVA|||NR4A2; Placebo vs GSK256066 10 mcg||2.83|1.24|0.0033
91503687|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|2.16|STANDARD_ERROR_OF_MEAN|0.092||0.0004|TWO_SIDED|95.0|1.42|3.3|||ANOVA|||NR4A2; Placebo vs GSK256066 50 mcg||3.30|1.42|0.0004
91503688|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|2.03|STANDARD_ERROR_OF_MEAN|0.091||0.001||95.0|1.34|3.08|||ANOVA|||NR4A2; Placebo vs GSK256066 200 mcg||3.08|1.34|0.0010
91503689|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.03|STANDARD_ERROR_OF_MEAN|0.072||0.8718|TWO_SIDED|95.0|0.74|1.43|||ANOVA|||PDE4A; Placebo vs GSK256066 1 mcg||1.43|0.74|0.8718
91748260|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.707|TWO_SIDED|95.0|-0.072|0.106|||Mixed Models Analysis|||Week 8||0.106|-0.072|0.707
91503690|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.18|STANDARD_ERROR_OF_MEAN|0.071||0.3078|TWO_SIDED|95.0|0.86|1.63|||ANOVA|||PDE4A; Placebo vs GSK256066 10 mcg||1.63|0.86|0.3078
91503691|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.072||0.2909|TWO_SIDED|95.0|0.86|1.66|||ANOVA|||PDE4A; Placebo vs GSK256066 50 mcg||1.66|0.86|0.2909
91503692|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.38|STANDARD_ERROR_OF_MEAN|0.071||0.0539|TWO_SIDED|95.0|0.99|1.91|||ANOVA|||PDE4A; Placebo vs GSK256066 200 mcg||1.91|0.99|0.0539
91503693|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.06|STANDARD_ERROR_OF_MEAN|0.081||0.7393|TWO_SIDED|95.0|0.74|1.54|||ANOVA|||RGS1; Placebo vs GSK256066 1 mcg||1.54|0.74|0.7393
91503694|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.21|STANDARD_ERROR_OF_MEAN|0.08||0.2967|TWO_SIDED|95.0|0.84|1.74|||ANOVA|||RGS1; Placebo vs GSK256066 10 mcg||1.74|0.84|0.2967
91748261|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.005||||0.904|TWO_SIDED|95.0|-0.083|0.094|||Mixed Models Analysis|||Week 8||0.094|-0.083|0.904
91503695|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.081||0.0934|TWO_SIDED|95.0|0.95|1.98|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||1.98|0.95|0.0934
91503696|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.08||0.0919|TWO_SIDED|95.0|0.95|1.97|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||1.97|0.95|0.0919
91503697|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|2.72|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.11|3.51|||ANOVA|||SNF1LK; Placebo vs GSK256066 1 mcg||3.51|2.11|<0.0001
91503698|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|3.04|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.37|3.9|||ANOVA|||SNF1LK; Placebo vs GSK256066 10 mcg||3.90|2.37|<0.0001
91503699|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|3.28|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.54|4.23|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||4.23|2.54|<0.0001
91503700|NCT00464568|182878715|SUPERIORITY_OR_OTHER||Treatment Ratios|3.32|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.59|4.27|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||4.27|2.59|<0.0001
91503701|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.5545|STANDARD_DEVIATION|7.79598||0.647226|||||||Mixed effects analysis of variance model|||Placebo vs GSK256066 1 mcg: VASP||||0.647226
91503702|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.3816|STANDARD_DEVIATION|9.00754||0.95084|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: VASP||||0.95084
91748262|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.121|TWO_SIDED|95.0|-0.018|0.157|||Mixed Models Analysis|||Week 8||0.157|-0.018|0.121
91748263|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.026|TWO_SIDED|95.0|0.012|0.188|||Mixed Models Analysis|||Week 8||0.188|0.012|0.026
91748264|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.139||||0.001|TWO_SIDED|95.0|0.055|0.224|||Mixed Models Analysis|||Week 8||0.224|0.055|0.001
91748265|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.122||||0.006|TWO_SIDED|95.0|0.035|0.209|||Mixed Models Analysis|||Week 8||0.209|0.035|0.006
91748266|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.856|TWO_SIDED|95.0|-0.068|0.081|||Mixed Models Analysis|||Treatment period average||0.081|-0.068|0.856
91503703|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|0.0256|STANDARD_DEVIATION|9.24118||0.53499|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 50 mcg: VASP||||0.53499
91503704|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.3371|STANDARD_DEVIATION|7.5459||0.81527|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: VASP||||0.81527
91503705|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|-2.8053|STANDARD_DEVIATION|10.88217||0.32998|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 1 mcg: pVASP||||0.32998
91503706|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.6602|STANDARD_DEVIATION|12.30724||0.65729|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: pVASP||||0.65729
91503707|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|0.156|STANDARD_DEVIATION|4.73976||0.89831|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 50 mcg: pVASP||||0.89831
91748267|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.832|TWO_SIDED|95.0|-0.066|0.082|||Mixed Models Analysis|||Treatment period average||0.082|-0.066|0.832
91748268|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.06|TWO_SIDED|95.0|-0.003|0.145|||Mixed Models Analysis|||Treatment period average||0.145|-0.003|0.060
91503708|NCT00464568|182878730|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.5165|STANDARD_DEVIATION|12.70748||0.84479|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: pVASP||||0.84479
91503709|NCT02255981|182878793|OTHER|Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.|Mean Difference (Final Values)|15.392|||<|0.05|TWO_SIDED|95.0||||"Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.~It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up."|t-test, 1 sided|From this estimation, it is induced that there are differences in results before and after the treatment.|The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.|"Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.~Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different."|The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.|||<0.05
91503710|NCT01232920|182878802|SUPERIORITY_OR_OTHER|||||||0.09|||||||Fisher Exact|||||||0.09
91503711|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.109|1.535||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95.||1.535|0.109|
91503712|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.43|3.282||||||Univariate Cox regression: Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.282|0.430|
91748269|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.011|TWO_SIDED|95.0|0.022|0.17|||Mixed Models Analysis|||Treatment period average||0.170|0.022|0.011
91748270|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.003|TWO_SIDED|95.0|0.039|0.181|||Mixed Models Analysis|||Treatment period average||0.181|0.039|0.003
91503713|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.306|2.425||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker c-MET.||2.425|0.306|
91748271|NCT03622112|183388777|SUPERIORITY||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.055|0.202|||Mixed Models Analysis|||Treatment period average||0.202|0.055|<0.001
91748272|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.936||||0.322|TWO_SIDED|95.0|0.822|1.067|||Mixed Models Analysis|||Week 2||1.067|0.822|0.322
91748273|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.876||||0.047|TWO_SIDED|95.0|0.768|0.999|||Mixed Models Analysis|||Week 2||0.999|0.768|0.047
91748274|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.842||||0.01|TWO_SIDED|95.0|0.739|0.959|||Mixed Models Analysis|||Week 2||0.959|0.739|0.010
91748275|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.825||||0.004|TWO_SIDED|95.0|0.724|0.941|||Mixed Models Analysis|||Week 2||0.941|0.724|0.004
91748276|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.687|||<|0.001|TWO_SIDED|95.0|0.606|0.779|||Mixed Models Analysis|||Week 2||0.779|0.606|<0.001
91748277|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.553|0.719|||Mixed Models Analysis|||Week 2||0.719|0.553|<0.001
91748278|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.931||||0.329|TWO_SIDED|95.0|0.805|1.076|||Mixed Models Analysis|||Week 4||1.076|0.805|0.329
91748279|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.911||||0.203|TWO_SIDED|95.0|0.789|1.052|||Mixed Models Analysis|||Week 4||1.052|0.789|0.203
91748280|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.923||||0.273|TWO_SIDED|95.0|0.8|1.065|||Mixed Models Analysis|||Week 4||1.065|0.800|0.273
91748281|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.846||||0.023|TWO_SIDED|95.0|0.734|0.977|||Mixed Models Analysis|||Week 4||0.977|0.734|0.023
91748282|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.742|||<|0.001|TWO_SIDED|95.0|0.646|0.852|||Mixed Models Analysis|||Week 4||0.852|0.646|<0.001
91748283|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.703|||<|0.001|TWO_SIDED|95.0|0.609|0.81|||Mixed Models Analysis|||Week 4||0.810|0.609|<0.001
91748284|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.917||||0.283|TWO_SIDED|95.0|0.783|1.074|||Mixed Models Analysis|||Week 8||1.074|0.783|0.283
91748285|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.933||||0.386|TWO_SIDED|95.0|0.797|1.092|||Mixed Models Analysis|||Week 8||1.092|0.797|0.386
91748286|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.886||||0.126|TWO_SIDED|95.0|0.758|1.035|||Mixed Models Analysis|||Week 8||1.035|0.758|0.126
91748287|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.855||||0.05|TWO_SIDED|95.0|0.731|1.0|||Mixed Models Analysis|||Week 8||1.000|0.731|0.050
91748288|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.723|||<|0.001|TWO_SIDED|95.0|0.623|0.84|||Mixed Models Analysis|||Week 8||0.840|0.623|<0.001
91748289|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.642|||<|0.001|TWO_SIDED|95.0|0.55|0.749|||Mixed Models Analysis|||Week 8||0.749|0.550|<0.001
91748290|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.927||||0.359|TWO_SIDED|95.0|0.789|1.09|||Mixed Models Analysis|||Week 12||1.090|0.789|0.359
91748291|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.953||||0.556|TWO_SIDED|95.0|0.813|1.118|||Mixed Models Analysis|||Week 12||1.118|0.813|0.556
91748292|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.869||||0.084|TWO_SIDED|95.0|0.742|1.019|||Mixed Models Analysis|||Week 12||1.019|0.742|0.084
91748293|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.813||||0.011|TWO_SIDED|95.0|0.693|0.953|||Mixed Models Analysis|||Week 12||0.953|0.693|0.011
91748294|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.65|||<|0.001|TWO_SIDED|95.0|0.559|0.757|||Mixed Models Analysis|||Week 12||0.757|0.559|<0.001
91748295|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.623|||<|0.001|TWO_SIDED|95.0|0.533|0.729|||Mixed Models Analysis|||Week 12||0.729|0.533|<0.001
91748296|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.928||||0.231|TWO_SIDED|95.0|0.821|1.049|||Mixed Models Analysis|||Treatment period average||1.049|0.821|0.231
91748297|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.918||||0.17|TWO_SIDED|95.0|0.812|1.037|||Mixed Models Analysis|||Treatment period average||1.037|0.812|0.170
91748298|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.879||||0.039|TWO_SIDED|95.0|0.778|0.994|||Mixed Models Analysis|||Treatment period average||0.994|0.778|0.039
91748299|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.835||||0.004|TWO_SIDED|95.0|0.739|0.943|||Mixed Models Analysis|||Treatment period average||0.943|0.739|0.004
91748300|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.622|0.787|||Mixed Models Analysis|||Treatment period average||0.787|0.622|<0.001
91748301|NCT03622112|183388778|SUPERIORITY||Mean Difference (Final Values)|0.649|||<|0.001|TWO_SIDED|95.0|0.575|0.732|||Mixed Models Analysis|||Treatment period average||0.732|0.575|<0.001
91748302|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|-0.034||||0.519|TWO_SIDED|95.0|-0.139|0.07|||Mixed Models Analysis|||Week 12||0.070|-0.139|0.519
91748303|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|-0.078||||0.141|TWO_SIDED|95.0|-0.181|0.026|||Mixed Models Analysis|||Week 12||0.026|-0.181|0.141
91748304|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.772|TWO_SIDED|95.0|-0.088|0.119|||Mixed Models Analysis|||Week 12||0.119|-0.088|0.772
91748305|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.27|TWO_SIDED|95.0|-0.045|0.162|||Mixed Models Analysis|||Week 12||0.162|-0.045|0.270
91748306|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.592|TWO_SIDED|95.0|-0.072|0.126|||Mixed Models Analysis|||Week 12||0.126|-0.072|0.592
91748307|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.275|TWO_SIDED|95.0|-0.045|0.158|||Mixed Models Analysis|||Week 12||0.158|-0.045|0.275
91748308|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.963|TWO_SIDED|95.0|-0.087|0.083|||Mixed Models Analysis|||Treatment period average||0.083|-0.087|0.963
91748309|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.533|TWO_SIDED|95.0|-0.112|0.058|||Mixed Models Analysis|||Treatment period average||0.058|-0.112|0.533
91748310|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.342|TWO_SIDED|95.0|-0.044|0.126|||Mixed Models Analysis|||Treatment period average||0.126|-0.044|0.342
91748311|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.061|TWO_SIDED|95.0|-0.004|0.165|||Mixed Models Analysis|||Treatment period average||0.165|-0.004|0.061
91748312|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.278|TWO_SIDED|95.0|-0.037|0.127|||Mixed Models Analysis|||Treatment period average||0.127|-0.037|0.278
91748313|NCT03622112|183388779|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.079|TWO_SIDED|95.0|-0.009|0.159|||Mixed Models Analysis|||Treatment period average||0.159|-0.009|0.079
91748314|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.153||||0.088|TWO_SIDED|95.0|-0.328|0.023|||Mixed Models Analysis|||Week 12||0.023|-0.328|0.088
91748315|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.257||||0.004|TWO_SIDED|95.0|-0.43|-0.084|||Mixed Models Analysis|||Week 12||-0.084|-0.430|0.004
91748316|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.221||||0.012|TWO_SIDED|95.0|-0.393|-0.049|||Mixed Models Analysis|||Week 12||-0.049|-0.393|0.012
91748317|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.193||||0.029|TWO_SIDED|95.0|-0.366|-0.02|||Mixed Models Analysis|||Week 12||-0.020|-0.366|0.029
91748318|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.269||||0.001|TWO_SIDED|95.0|-0.434|-0.104|||Mixed Models Analysis|||Week 12||-0.104|-0.434|0.001
91748319|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.01|TWO_SIDED|95.0|-0.393|-0.054|||Mixed Models Analysis|||Week 12||-0.054|-0.393|0.010
91748320|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.125||||0.055|TWO_SIDED|95.0|-0.253|0.003|||Mixed Models Analysis|||Treatment period average||0.003|-0.253|0.055
91748321|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.141||||0.029|TWO_SIDED|95.0|-0.268|-0.014|||Mixed Models Analysis|||Treatment period average||-0.014|-0.268|0.029
91748322|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.044|TWO_SIDED|95.0|-0.257|-0.003|||Mixed Models Analysis|||Treatment period average||-0.003|-0.257|0.044
91748323|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.201||||0.002|TWO_SIDED|95.0|-0.328|-0.074|||Mixed Models Analysis|||Treatment period average||-0.074|-0.328|0.002
91748324|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.217|||<|0.001|TWO_SIDED|95.0|-0.339|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.339|<0.001
91748325|NCT03622112|183388780|SUPERIORITY||Mean Difference (Final Values)|-0.179||||0.005|TWO_SIDED|95.0|-0.305|-0.053|||Mixed Models Analysis|||Treatment period average||-0.053|-0.305|0.005
91748326|NCT03622112|183388781|SUPERIORITY||Mean Difference (Final Values)|7.664||||0.097|TWO_SIDED|95.0|-1.403|16.73|||Mixed Models Analysis|||Treatment period average||16.730|-1.403|0.097
91748327|NCT03622112|183388781|SUPERIORITY||Mean Difference (Final Values)|5.981||||0.19|TWO_SIDED|95.0|-2.98|14.941|||Mixed Models Analysis|||Treatment period average||14.941|-2.980|0.190
91748328|NCT03622112|183388781|SUPERIORITY||Mean Difference (Final Values)|9.123||||0.045|TWO_SIDED|95.0|0.195|18.052|||Mixed Models Analysis|||Treatment period average||18.052|0.195|0.045
91748329|NCT03622112|183388781|SUPERIORITY||Mean Difference (Final Values)|15.444|||<|0.001|TWO_SIDED|95.0|6.443|24.445|||Mixed Models Analysis|||Treatment period average||24.445|6.443|<0.001
91748330|NCT03622112|183388781|SUPERIORITY||Mean Difference (Final Values)|16.599|||<|0.001|TWO_SIDED|95.0|8.031|25.167|||Mixed Models Analysis|||Treatment period average||25.167|8.031|<0.001
91748331|NCT03622112|183388781|SUPERIORITY||Mean Difference (Final Values)|10.491||||0.019|TWO_SIDED|95.0|1.726|19.256|||Mixed Models Analysis|||Treatment period average||19.256|1.726|0.019
91748332|NCT03622112|183388782|SUPERIORITY||Mean Difference (Final Values)|2.398||||0.597|TWO_SIDED|95.0|-6.494|11.29|||Mixed Models Analysis|||Treatment period average||11.290|-6.494|0.597
91748333|NCT03622112|183388782|SUPERIORITY||Mean Difference (Final Values)|2.162||||0.629|TWO_SIDED|95.0|-6.623|10.948|||Mixed Models Analysis|||Treatment period average||10.948|-6.623|0.629
91748334|NCT03622112|183388782|SUPERIORITY||Mean Difference (Final Values)|3.833||||0.389|TWO_SIDED|95.0|-4.907|12.573|||Mixed Models Analysis|||Treatment period average||12.573|-4.907|0.389
91748335|NCT03622112|183388782|SUPERIORITY||Mean Difference (Final Values)|10.258||||0.022|TWO_SIDED|95.0|1.456|19.059|||Mixed Models Analysis|||Treatment period average||19.059|1.456|0.022
91748336|NCT03622112|183388782|SUPERIORITY||Mean Difference (Final Values)|11.994||||0.005|TWO_SIDED|95.0|3.571|20.417|||Mixed Models Analysis|||Treatment period average||20.417|3.571|0.005
91748337|NCT03622112|183388782|SUPERIORITY||Mean Difference (Final Values)|6.129||||0.163|TWO_SIDED|95.0|-2.479|14.737|||Mixed Models Analysis|||Treatment period average||14.737|-2.479|0.163
91748338|NCT03622112|183388783|SUPERIORITY||Mean Difference (Final Values)|-0.243||||0.012|TWO_SIDED|95.0|-0.431|-0.054|||Mixed Models Analysis|||Treatment period average||-0.054|-0.431|0.012
91748339|NCT03622112|183388783|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.108|TWO_SIDED|95.0|-0.344|0.034|||Mixed Models Analysis|||Treatment period average||0.034|-0.344|0.108
91748340|NCT03622112|183388783|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.295|TWO_SIDED|95.0|-0.286|0.087|||Mixed Models Analysis|||Treatment period average||0.087|-0.286|0.295
91748341|NCT03622112|183388783|SUPERIORITY||Mean Difference (Final Values)|-0.308||||0.002|TWO_SIDED|95.0|-0.5|-0.116|||Mixed Models Analysis|||Treatment period average||-0.116|-0.500|0.002
91748342|NCT03622112|183388783|SUPERIORITY||Mean Difference (Final Values)|-0.308|||<|0.001|TWO_SIDED|95.0|-0.489|-0.126|||Mixed Models Analysis|||Treatment period average||-0.126|-0.489|<0.001
91748343|NCT03622112|183388783|SUPERIORITY||Mean Difference (Final Values)|-0.177||||0.062|TWO_SIDED|95.0|-0.362|0.009|||Mixed Models Analysis|||Treatment period average||0.009|-0.362|0.062
91748344|NCT03622112|183388784|SUPERIORITY||Mean Difference (Final Values)|-9.993|||<|0.001|TWO_SIDED|95.0|-15.795|-4.191|||Mixed Models Analysis|||Treatment period average||-4.191|-15.795|<0.001
91748345|NCT03622112|183388784|SUPERIORITY||Mean Difference (Final Values)|-7.972||||0.006|TWO_SIDED|95.0|-13.694|-2.251|||Mixed Models Analysis|||Treatment period average||-2.251|-13.694|0.006
91748346|NCT03622112|183388784|SUPERIORITY||Mean Difference (Final Values)|-4.361||||0.133|TWO_SIDED|95.0|-10.051|1.329|||Mixed Models Analysis|||Treatment period average||1.329|-10.051|0.133
91748347|NCT03622112|183388784|SUPERIORITY||Mean Difference (Final Values)|-7.797||||0.008|TWO_SIDED|95.0|-13.555|-2.04|||Mixed Models Analysis|||Treatment period average||-2.040|-13.555|0.008
91748348|NCT03622112|183388784|SUPERIORITY||Mean Difference (Final Values)|-8.729||||0.002|TWO_SIDED|95.0|-14.195|-3.264|||Mixed Models Analysis|||Treatment period average||-3.264|-14.195|0.002
91748349|NCT03622112|183388784|SUPERIORITY||Mean Difference (Final Values)|-11.622|||<|0.001|TWO_SIDED|95.0|-17.211|-6.034|||Mixed Models Analysis|||Treatment period average||-6.034|-17.211|<0.001
91748350|NCT03622112|183388785|SUPERIORITY||Mean Difference (Final Values)|-0.212|||<|0.001|TWO_SIDED|95.0|-0.329|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.329|<0.001
91748351|NCT03622112|183388785|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.066|TWO_SIDED|95.0|-0.228|0.007|||Mixed Models Analysis|||Treatment period average||0.007|-0.228|0.066
91748352|NCT03622112|183388785|SUPERIORITY||Mean Difference (Final Values)|-0.139||||0.02|TWO_SIDED|95.0|-0.255|-0.022|||Mixed Models Analysis|||Treatment period average||-0.022|-0.255|0.020
91748353|NCT03622112|183388785|SUPERIORITY||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.35|-0.11|||Mixed Models Analysis|||Treatment period average||-0.110|-0.350|<0.001
91748354|NCT03622112|183388785|SUPERIORITY||Mean Difference (Final Values)|-0.185||||0.001|TWO_SIDED|95.0|-0.298|-0.071|||Mixed Models Analysis|||Treatment period average||-0.071|-0.298|0.001
91748355|NCT03622112|183388785|SUPERIORITY||Mean Difference (Final Values)|-0.206|||<|0.001|TWO_SIDED|95.0|-0.321|-0.09|||Mixed Models Analysis|||Treatment period average||-0.090|-0.321|<0.001
91748356|NCT03622112|183388786|SUPERIORITY||Mean Difference (Final Values)|9.611||||0.026|TWO_SIDED|95.0|1.18|18.042|||Mixed Models Analysis|||Treatment period average||18.042|1.180|0.026
91503714|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.164|1.453||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \<median / ≥median) for the biomarker PTEN.||1.453|0.164|
91503715|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.377|3.16||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||3.160|0.377|
91503716|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.409|4.132||||||Univariate Cox regression Hazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||4.132|0.409|
91503717|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.183|||||TWO_SIDED|95.0|0.226|6.197||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||6.197|0.226|
91503718|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.989|||||TWO_SIDED|95.0|0.378|10.47||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||10.470|0.378|
91503719|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Univariate Cox regression Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
91503720|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
91503721|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.082|6.72||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||6.720|0.082|
91503722|NCT00885755|182878807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.274|4.199||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||4.199|0.274|
91748357|NCT03622112|183388786|SUPERIORITY||Mean Difference (Final Values)|5.503||||0.2|TWO_SIDED|95.0|-2.927|13.933|||Mixed Models Analysis|||Treatment period average||13.933|-2.927|0.200
91503723|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.12|1.79||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95 HER2.||1.790|0.120|
91503724|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.394|3.518||||||Univariate Cox regressionHazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.518|0.394|
91503725|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.268|2.514||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker c-met.||2.514|0.268|
91503726|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.183|1.768||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \< median / ≥median) for the marker PTEN.||1.768|0.183|
91503727|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.242|2.733||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||2.733|0.242|
91503728|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.337|3.632||||||Univariate Cox regressionHazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||3.632|0.337|
91748358|NCT03622112|183388786|SUPERIORITY||Mean Difference (Final Values)|6.787||||0.11|TWO_SIDED|95.0|-1.546|15.119|||Mixed Models Analysis|||Treatment period average||15.119|-1.546|0.110
91748359|NCT03622112|183388786|SUPERIORITY||Mean Difference (Final Values)|10.066||||0.022|TWO_SIDED|95.0|1.461|18.672|||Mixed Models Analysis|||Treatment period average||18.672|1.461|0.022
91748360|NCT03622112|183388786|SUPERIORITY||Mean Difference (Final Values)|8.62||||0.038|TWO_SIDED|95.0|0.489|16.75|||Mixed Models Analysis|||Treatment period average||16.750|0.489|0.038
91503729|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.172|5.336||||||Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||5.336|0.172|
91503730|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.666|||||TWO_SIDED|95.0|0.298|9.305||||||Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||9.305|0.298|
91503731|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
91503732|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
91503733|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956|||||TWO_SIDED|95.0|0.098|9.319||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||9.319|0.098|
91503734|NCT00885755|182878810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.292|||||TWO_SIDED|95.0|0.296|5.64||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||5.640|0.296|
91503735|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.03|||||TWO_SIDED|95.0|0.001|0.641||||||Univariate logistic regression Odds ratio (Positive / Negative) for the biomarker p95 HER 2.||0.641|0.001|
91503736|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.208|||||TWO_SIDED|95.0|0.017|2.6||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\<median) for the biomarker IGF1R.||2.600|0.017|
91503737|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.143|||||TWO_SIDED|95.0|0.169|27.103||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥ median /\<median) for the biomarker c-MET.||27.103|0.169|
91503738|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.875|||||TWO_SIDED|95.0|0.15|23.396||||||Univariate logistic regression Odds ratio (Cytoplasm H-Score: ≥ median /\< median) for the biomarker PTEN.||23.396|0.150|
91503739|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.857|||||TWO_SIDED|95.0|0.091|8.075||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\< median) for the biomarker HER2.||8.075|0.091|
91503740|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.148|||||TWO_SIDED|95.0|0.012|1.9||||||Univariate logistic regression Odds ratio (PI3K mutation status: WT versus M) for the biomarker PI3K Amino Acids.||1.900|0.012|
91503741|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.053|18.915||||||Univariate logistic regressionOdds ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||18.915|0.053|
91503742|NCT00885755|182878818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.083|||||TWO_SIDED|95.0|0.004|1.945||||||Univariate logistic regression Odds ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H||1.945|0.004|
91503743|NCT01334723|182878826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||||95.0|0.35|0.412|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.412|0.350|
91503744|NCT01334723|182878826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.294||||||95.0|0.235|0.368|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.368|0.235|
91503745|NCT01334723|182878827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.613||||||95.0|0.562|0.668|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.668|0.562|
91503746|NCT01334723|182878827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542||||||95.0|0.427|0.689|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.689|0.427|
91503747|NCT01334723|182878828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519||||||95.0|0.472|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.472|
91503748|NCT01334723|182878828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.436||||||95.0|0.333|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.333|
91503749|NCT04649164|182878863|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Paired t-tests comparing peer mentors' baseline and 16-week scores, and caregiver mentees' baseline and 16-week scores, respectively||||0.36
91503750|NCT04649164|182878865|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
91503751|NCT04649164|182878866|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91503752|NCT04649164|182878867|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
91503753|NCT04649164|182878870|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91503754|NCT01549964|182878892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.77|-0.34||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.34|-0.77|<0.001
91503755|NCT01549964|182878892|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.15|0.49||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.49|0.15|<0.001
91503756|NCT01549964|182878892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.03|-0.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.60|-1.03|<0.001
91503757|NCT01549964|182878892|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.524|TWO_SIDED|95.0|-0.12|0.23||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.23|-0.12|0.524
91503758|NCT01549964|182878893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.05|TWO_SIDED|95.0|1.0|5.08||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||5.08|1.00|0.050
91748361|NCT03622112|183388786|SUPERIORITY||Mean Difference (Final Values)|7.178||||0.09|TWO_SIDED|95.0|-1.112|15.467|||Mixed Models Analysis|||Treatment period average||15.467|-1.112|0.090
91503759|NCT01549964|182878893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.67||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||0.67|0.23|<0.001
91503760|NCT01549964|182878893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.06|||<|0.001|TWO_SIDED|95.0|2.24|11.42||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||11.42|2.24|<0.001
91748362|NCT03622112|183388787|SUPERIORITY||Mean Difference (Final Values)|7.936||||0.123|TWO_SIDED|95.0|-2.16|18.031|||Mixed Models Analysis|||Treatment period average||18.031|-2.160|0.123
91748363|NCT03622112|183388787|SUPERIORITY||Mean Difference (Final Values)|0.977||||0.849|TWO_SIDED|95.0|-9.112|11.065|||Mixed Models Analysis|||Treatment period average||11.065|-9.112|0.849
91748364|NCT03622112|183388787|SUPERIORITY||Mean Difference (Final Values)|-1.242||||0.807|TWO_SIDED|95.0|-11.233|8.748|||Mixed Models Analysis|||Treatment period average||8.748|-11.233|0.807
91748365|NCT03622112|183388787|SUPERIORITY||Mean Difference (Final Values)|11.789||||0.025|TWO_SIDED|95.0|1.488|22.09|||Mixed Models Analysis|||Treatment period average||22.090|1.488|0.025
91748366|NCT03622112|183388787|SUPERIORITY||Mean Difference (Final Values)|7.574||||0.127|TWO_SIDED|95.0|-2.16|17.307|||Mixed Models Analysis|||Treatment period average||17.307|-2.160|0.127
91748367|NCT03622112|183388787|SUPERIORITY||Mean Difference (Final Values)|5.058||||0.318|TWO_SIDED|95.0|-4.874|14.99|||Mixed Models Analysis|||Treatment period average||14.990|-4.874|0.318
91748368|NCT03622112|183388788|SUPERIORITY||Mean Difference (Final Values)|10.45||||0.015|TWO_SIDED|95.0|2.046|18.855|||Mixed Models Analysis|||Treatment period average||18.855|2.046|0.015
91748369|NCT03622112|183388788|SUPERIORITY||Mean Difference (Final Values)|7.192||||0.093|TWO_SIDED|95.0|-1.208|15.592|||Mixed Models Analysis|||Treatment period average||15.592|-1.208|0.093
91748370|NCT03622112|183388788|SUPERIORITY||Mean Difference (Final Values)|8.606||||0.042|TWO_SIDED|95.0|0.298|16.913|||Mixed Models Analysis|||Treatment period average||16.913|0.298|0.042
91748371|NCT03622112|183388788|SUPERIORITY||Mean Difference (Final Values)|11.344||||0.01|TWO_SIDED|95.0|2.773|19.914|||Mixed Models Analysis|||Treatment period average||19.914|2.773|0.010
91748372|NCT03622112|183388788|SUPERIORITY||Mean Difference (Final Values)|10.122||||0.014|TWO_SIDED|95.0|2.021|18.222|||Mixed Models Analysis|||Treatment period average||18.222|2.021|0.014
91748373|NCT03622112|183388788|SUPERIORITY||Mean Difference (Final Values)|10.689||||0.011|TWO_SIDED|95.0|2.424|18.953|||Mixed Models Analysis|||Treatment period average||18.953|2.424|0.011
91748374|NCT03622112|183388799|SUPERIORITY||geometric LSMean ratio|1.01||||0.909|TWO_SIDED|95.0|0.851|1.199|||Mixed Models Analysis|||||1.199|0.851|0.909
91748375|NCT03622112|183388799|SUPERIORITY||geometric LSMean ratio|1.118||||0.218|TWO_SIDED|95.0|0.935|1.336|||Mixed Models Analysis|||||1.336|0.935|0.218
91748376|NCT03622112|183388799|SUPERIORITY||geometric LSMean ratio|1.129||||0.181|TWO_SIDED|95.0|0.944|1.349|||Mixed Models Analysis|||||1.349|0.944|0.181
91748377|NCT03622112|183388799|SUPERIORITY||geometric LSMean ratio|0.984||||0.859|TWO_SIDED|95.0|0.825|1.174|||Mixed Models Analysis|||||1.174|0.825|0.859
91748378|NCT03622112|183388799|SUPERIORITY||geometric LSMean ratio|0.916||||0.285|TWO_SIDED|95.0|0.78|1.077|||Mixed Models Analysis|||||1.077|0.780|0.285
91748379|NCT03622112|183388799|SUPERIORITY||geometric LSMean ratio|0.991||||0.923|TWO_SIDED|95.0|0.831|1.182|||Mixed Models Analysis|||||1.182|0.831|0.923
91748380|NCT02075047|183388818|SUPERIORITY||Difference in least square (LS) mean|-4.23|STANDARD_ERROR_OF_MEAN|1.47||0.005|TWO_SIDED|95.0|-7.14|-1.32|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.32|-7.14|0.005
91748381|NCT02075047|183388819|SUPERIORITY||Difference in LS mean|-0.45|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.69|-0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.20|-0.69|<0.001
91748382|NCT02075047|183388819|SUPERIORITY||Difference in LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.174|TWO_SIDED|95.0|-0.53|0.1|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.10|-0.53|0.174
91748383|NCT02075047|183388819|SUPERIORITY||Difference in LS mean|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.71|-0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.05|-0.71|0.024
91748384|NCT02075047|183388819|SUPERIORITY||Difference in LS mean|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.138|TWO_SIDED|95.0|-0.64|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.64|0.138
91748385|NCT02075047|183388820|SUPERIORITY||Difference in LS mean|-5.85|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|TWO_SIDED|95.0|-8.16|-3.54|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.54|-8.16|<0.001
91748386|NCT02075047|183388820|SUPERIORITY||Difference in LS mean|-4.17|STANDARD_ERROR_OF_MEAN|1.3||0.002|TWO_SIDED|95.0|-6.74|-1.59|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.59|-6.74|0.002
91503761|NCT01549964|182878893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.493|TWO_SIDED|95.0|0.5|1.39||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||1.39|0.50|0.493
91503762|NCT01549964|182878894|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-33.8|-16.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-16.6|-33.8|<0.001
91503763|NCT01549964|182878894|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|3.49||0.142|TWO_SIDED|95.0|-12.0|1.7||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||1.7|-12.0|0.142
91503764|NCT01549964|182878894|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-39.9|-22.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-22.6|-39.9|<0.001
91503765|NCT01549964|182878894|SUPERIORITY_OR_OTHER||Least Square Mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.53||0.002|TWO_SIDED|95.0|-18.1|-4.2||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.2|-18.1|0.002
91748387|NCT02075047|183388820|SUPERIORITY||Difference in LS mean|-5.63|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|-8.21|-3.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.04|-8.21|<0.001
91503766|NCT00499096|182878931|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
91503767|NCT02245841|182878949|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||< .001
91503768|NCT02245841|182878950|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
91503769|NCT02245841|182878951|SUPERIORITY|||||||0.002|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.002
91503770|NCT02245841|182878952|SUPERIORITY|||||||0.05|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.050
91503771|NCT02245841|182878953|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
91503772|NCT02438722|182878957|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.44|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||||1.36|0.50|0.44
91503773|NCT02438722|182878958|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.72|1.43|||Log Rank|||||1.43|0.72|0.94
91503774|NCT02438722|182878960|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.54|TWO_SIDED|95.0|0.64|1.26|||Log Rank|||||1.26|0.64|0.54
91503775|NCT02438722|182878961|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.73|1.39|||Log Rank|||||1.39|0.73|0.95
91503776|NCT03343483|182878969|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|1.06||0.896|TWO_SIDED|95.0|-2.21|1.93|||Mixed Models Analysis|||||1.93|-2.21|.896
91503777|NCT03343483|182878970|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.8|TWO_SIDED||||||ANOVA|||||||0.80
91503778|NCT03343483|182878971|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
91503779|NCT03343483|182878972|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
91503780|NCT03343483|182878973|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
91503781|NCT03343483|182878974|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.57|TWO_SIDED||||||Mixed Models Analysis|||||||0.57
91503782|NCT01835743|182878975|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
91503783|NCT01835743|182878976|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups||||||<0.0001
91503784|NCT00117559|182878994|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
91503785|NCT04949165|182878995|NON_INFERIORITY|The study employed a non-inferiority design with a non-inferiority margin of 1 g/dL for haemoglobin levels at 4 months, a 1-sided alpha level of 0.025, at least 85% power and under the assumption that the true difference in the means was 0.3 g/dL. The estimated sample size also allowed for up to 10% loss to follow- up or iron supplementation for those initially not requiring supplements, thus the sample size was 292.||||||0.025||||||Non-inferiority threshold of -1 g/dL for the lower bound of the 97.5% CI.|t-test, 1 sided|||||||0.025
91503786|NCT00579826|182879008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91503787|NCT00579826|182879009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91503788|NCT00579826|182879010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91503789|NCT00579826|182879011|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91503790|NCT00579826|182879012|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91503791|NCT04191382|182879013|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.08|||||TWO_SIDED|95.0|0.72|1.63||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 400 mg versus Letrozole 2.5 mg).||1.63|0.72|
91748388|NCT02075047|183388821|SUPERIORITY||Difference in LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|95.0|-0.78|-0.26|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.26|-0.78|0.001
91748389|NCT02075047|183388821|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.349|TWO_SIDED|95.0|-0.45|0.16|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.16|-0.45|0.349
91748390|NCT02075047|183388821|SUPERIORITY||Difference in LS mean|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.103|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.05|-0.57|0.103
91748391|NCT02075047|183388821|SUPERIORITY||Difference in LS mean|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.044|TWO_SIDED|95.0|-0.68|-0.01|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.01|-0.68|0.044
91748392|NCT02075047|183388835|SUPERIORITY||Difference in LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|0.00|0.050
91748393|NCT02075047|183388835|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.124|TWO_SIDED|95.0|-0.03|0.25|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.25|-0.03|0.124
91748394|NCT02075047|183388835|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.23|-0.01|0.084
91748395|NCT02075047|183388835|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|95.0|-0.02|0.2|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|-0.02|0.104
91748396|NCT02075047|183388836|SUPERIORITY||Difference in LS mean|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.169|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.01|-0.06|0.169
91748397|NCT02075047|183388836|SUPERIORITY||Difference in LS mean|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.893|TWO_SIDED|95.0|-0.1|0.08|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.08|-0.10|0.893
91748398|NCT02075047|183388836|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.915|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.04|0.915
91748399|NCT02075047|183388836|SUPERIORITY||Difference in LS mean|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.289|TWO_SIDED|95.0|-0.01|0.04|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.01|0.289
91748400|NCT02075047|183388837|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.145|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.06|-0.01|0.145
91748401|NCT02075047|183388837|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.148|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.07|-0.01|0.148
91748402|NCT02075047|183388837|SUPERIORITY||Difference in LS mean|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.082|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.15|-0.01|0.082
91748403|NCT02075047|183388837|SUPERIORITY||Difference in LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.00|0.070
91748404|NCT01155466|183388838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.62|0.53|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated mean change from baseline in mean off time for preladenant 10 mg - placebo."|||0.53|-0.62|0.8700
91503792|NCT04191382|182879013|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.42|||||TWO_SIDED|95.0|0.95|2.12||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 200 mg versus Letrozole 2.5 mg).||2.12|0.95|
91503793|NCT01748643|182879018|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91503794|NCT01748643|182879019|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91503795|NCT01748643|182879020|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91503796|NCT01748643|182879021|SUPERIORITY|||||||0.97|||||||t-test, 1 sided|||||||0.97
91748405|NCT01155466|183388840|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.899|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 2 mg - placebo|||1.6|-7.3|0.899
91503797|NCT01748643|182879022|SUPERIORITY|||||||0.64|||||||t-test, 1 sided|||||||0.64
91748406|NCT01155466|183388840|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.815|TWO_SIDED|95.0|-6.8|2.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 5 mg - placebo|||2.6|-6.8|0.815
91503798|NCT01748643|182879023|SUPERIORITY|||||||0.58|||||||t-test, 1 sided|||||||0.58
91503799|NCT03054870|182879061|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
91503800|NCT03054870|182879062|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
91503801|NCT03054870|182879063|OTHER||||||||||||||||||Estimates of inter-observer percent agreement were obtained as follows. For each reader-pair, binary agreement scores by subject and lung region were analyzed using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement.|||
91503802|NCT03054870|182879064|OTHER||||||||||||||||||For each pair of readers, by lung region estimates of kappa statistics and their corresponding 95% confidence intervals were generated from cross-tabulation frequencies of the readers' ventilation scores using SAS® PROC FREQ and the AGREE option.|||
91503803|NCT02009046|182879065|SUPERIORITY||Odds Ratio (OR)|1.09||||0.643|TWO_SIDED|95.0|0.75|1.6|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.60|0.75|0.6430
91503804|NCT02009046|182879065|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3718|TWO_SIDED|95.0|0.39|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.39|0.3718
91503805|NCT02009046|182879066|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8083|TWO_SIDED|95.0|0.67|1.37|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.37|0.67|0.8083
91503806|NCT02009046|182879066|SUPERIORITY||Odds Ratio (OR)|0.6||||0.1083|TWO_SIDED|95.0|0.32|1.13|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.13|0.32|0.1083
91503807|NCT02009046|182879067|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1006|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.10|0.35|0.1006
91748407|NCT01155466|183388840|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4||||0.295|TWO_SIDED|95.0|-3.9|6.9|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 10 mg - placebo|||6.9|-3.9|0.295
91748408|NCT01155466|183388843|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.629|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 2 mg - placebo|||3.7|-5.1|0.629
91748409|NCT01155466|183388843|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.625|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 5 mg - placebo|||3.7|-5.1|0.625
91748410|NCT01155466|183388843|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.948|TWO_SIDED|95.0|-6.8|0.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 10 mg - placebo|||0.7|-6.8|0.948
91748411|NCT01155466|183388844|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.7044|TWO_SIDED|95.0|-0.61|0.9|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 2 mg - placebo|||0.90|-0.61|0.7044
91748412|NCT01155466|183388844|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.3439|TWO_SIDED|95.0|-0.4|1.14|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 5 mg - placebo|||1.14|-0.4|0.3439
91748413|NCT01155466|183388844|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.3941|TWO_SIDED|95.0|-0.43|1.08|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 10 mg - placebo|||1.08|-0.43|0.3941
91748414|NCT01155466|183388845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.983|TWO_SIDED|95.0|0.597|1.657|||Mixed Models Analysis|Odds ratio was calculated for all randomized and treated participants with at least 1 post treatment value.|"Confidence intervals and P-values were based on a generalized linear mixed model with baseline average off time as a covariate and treatment-by-time interaction as fixed effect and participant as random effect."|||1.657|0.597|0.983
91748415|NCT01155466|183388846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6405|TWO_SIDED|95.0|-0.49|0.8|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated change from baseline in on time without troublesome dyskinesias for preladenant 10 mg - placebo."|||0.80|-0.49|0.6405
91748416|NCT00075946|183388847|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.33|TWO_SIDED|95.0|0.9|1.88|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.||1.88|0.90|0.33
91748417|NCT00075946|183388847|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.75||||0.012|TWO_SIDED|95.0|1.22|6.19|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.|||6.19|1.22|0.012
91748418|NCT00075946|183388848|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.21||||0.002|TWO_SIDED|95.0|1.45|7.13|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|||7.13|1.45|0.002
91748419|NCT00075946|183388848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
91748420|NCT00075946|183388849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.270
91748421|NCT03552536|183388852|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. Least squares (LS) mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-0.6|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8583 and placebo at least 0.5 log10 copies/mL was 64%.|||||
91748422|NCT03639623|183388871|OTHER|||||||0.053|||||||paired t-test|||||||0.053
91748423|NCT03639623|183388872|OTHER|||||||0.958|||||||paired t-test|||||||0.958
91748424|NCT03639623|183388873|OTHER|||||||0.011|||||||paired t-test|||||||0.011
91748425|NCT03639623|183388874|OTHER|||||||0.454|||||||paired t-test|||||||0.454
91748426|NCT03639623|183388875|OTHER|||||||0.154|||||||paired t-test|||||||0.154
91748427|NCT03639623|183388876|OTHER|||||||0.125|||||||paired t-test|||Outcome Variable: ALT||||0.125
91748428|NCT03639623|183388876|OTHER|||||||0.375|||||||paired t-test|||Outcome Variable: AST||||0.375
91748429|NCT03639623|183388876|OTHER||||||<|0.001|||||||paired t-test|||Outcome Variable: ALP||||<0.001
91748430|NCT03639623|183388877|OTHER|||||||0.054|||||||paired t-test|||||||0.054
91748431|NCT03639623|183388878|OTHER|||||||0.378|||||||paired t-test|||Outcome variable: Total Cholesterol||||0.378
91748432|NCT03639623|183388878|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: Triglyceride||||0.010
91748433|NCT03639623|183388878|OTHER|||||||0.264|||||||paired t-test|||Outcome Variable: Non-HDL-C||||0.264
91748434|NCT03639623|183388878|OTHER|||||||0.954|||||||paired t-test|||Outcome Variable: HDL-C||||0.954
91748435|NCT03639623|183388878|OTHER|||||||0.127|||||||paired t-test|||Outcome Variable: HDL-C Subclass 2||||0.127
91748436|NCT03639623|183388878|OTHER|||||||0.029|||||||paired t-test|||Outcome Variable: HDL-C Subclass 3||||0.029
91748437|NCT03639623|183388878|OTHER|||||||0.63|||||||paired t-test|||Outcome variable: LDL-C||||0.630
91748438|NCT03639623|183388878|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: VLDL-C||||0.010
91748439|NCT03639623|183388878|OTHER|||||||0.16|||||||paired t-test|||Outcome Variable: VLDL concentration||||0.160
91748440|NCT03639623|183388878|OTHER|||||||0.02|||||||paired t-test|||Small dense LDL-C||||0.020
91748441|NCT03639623|183388879|OTHER|||||||0.529|||||||paired t-test|||||||0.529
91748442|NCT03639623|183388880|OTHER|||||||0.403|||||||paired t-test|||Outcome Variable: LDL Size||||0.403
91748443|NCT03639623|183388881|OTHER|||||||0.669|||||||paired t-test|||||||0.669
91748444|NCT03639623|183388882|OTHER|||||||0.021|||||||paired t-test|||Outcome Variable: VLDL chylomicron particles||||0.021
91748445|NCT03639623|183388882|OTHER|||||||0.011|||||||paired t-test|||Outcome Variable: Large VLDL chylomicron particles||||0.011
91748446|NCT03639623|183388882|OTHER|||||||0.06|||||||paired t-test|||Outcome Variable: Medium VLDL particles||||0.060
91748447|NCT03639623|183388882|OTHER|||||||0.324|||||||paired t-test|||Outcome Variable: Small VLDL particles||||0.324
91748448|NCT03639623|183388883|OTHER|||||||0.01|||||||paired t-test|||||||0.010
91748449|NCT03639623|183388884|OTHER|||||||0.249|||||||paired t-test|||||||0.249
91748450|NCT03639623|183388885|OTHER|||||||0.0193|||||||paired t-test|||Time to peak RQ||||0.0193
91748451|NCT03639623|183388886|OTHER|||||||0.96|||||||paired t-test|||Outcome Variable: Physical component score||||0.960
91503808|NCT02009046|182879067|SUPERIORITY||Odds Ratio (OR)|0.49||||0.2117|TWO_SIDED|95.0|0.16|1.53|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.53|0.16|0.2117
91531750|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
91531751|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.3|-1.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.3|-4.3|<0.001
91531752|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.4|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.4|<0.001
91531753|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.4|-1.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.1|-3.4|<0.001
91531754|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.71||0.36|TWO_SIDED|95.0|-2.0|0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.8|-2.0|0.36
91531755|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.72||0.009|TWO_SIDED|95.0|-3.3|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-3.3|0.009
91531756|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-4.5|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-4.5|<0.001
91748452|NCT03639623|183388886|OTHER|||||||0.249|||||||paired t-test|||Outcome Variable: Mental component score||||0.249
91503809|NCT02009046|182879068|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0218|TWO_SIDED|95.0|1.05|1.78|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.78|1.05|0.0218
91531757|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.69||0.042|TWO_SIDED|95.0|-2.7|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.1|-2.7|0.042
91748453|NCT01229254|183388904|EQUIVALENCE|If the 90% confidence interval was within the pre-specified bounds of \[0.66, 1.50\], the hypothesis of similarity between lower weight and higher weight groups was supported.|Ratio of geometric least-squares means|0.748|||||TWO_SIDED|90.0|0.591|0.948||||||Compared to Betrixaban 90 mg (≥80 kg)||0.948|0.591|
91748454|NCT01191736|183388908|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Null hypothesis: the medians for all seven arms are equal.||Kruskal-Wallis test for multiple comparisons||||.05
91748455|NCT01191736|183388909|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|Null hypothesis: the proportions within the seven arms are equal.||Comparison of proportions of subjects who assessed responsiveness||||.05
91503810|NCT02009046|182879068|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0211|TWO_SIDED|95.0|1.09|2.75|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.75|1.09|0.0211
91503811|NCT02009046|182879069|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1763|TWO_SIDED|95.0|0.9|1.73|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.73|0.90|0.1763
91503812|NCT02009046|182879069|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5869|TWO_SIDED|95.0|0.45|1.58|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.58|0.45|0.5869
91503813|NCT02009046|182879070|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8102|TWO_SIDED|95.0|0.75|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.75|0.8102
91748456|NCT03119181|183388912|SUPERIORITY|||||||0.0097|||||||one-sided permutation test|||one-sided permutation test at 2.5% significance||||0.0097
91503814|NCT02009046|182879070|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2956|TWO_SIDED|95.0|0.39|1.34|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.34|0.39|0.2956
91503815|NCT02009046|182879071|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4645|TWO_SIDED|95.0|0.82|1.56|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.56|0.82|0.4645
91503816|NCT02009046|182879071|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3809|TWO_SIDED|95.0|0.43|1.4|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.40|0.43|0.3809
91503817|NCT02009046|182879072|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1335|TWO_SIDED|95.0|0.52|1.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.09|0.52|0.1335
91503818|NCT02009046|182879072|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0741|TWO_SIDED|95.0|0.29|1.06|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.06|0.29|0.0741
91503819|NCT02009046|182879073|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9085|TWO_SIDED|95.0|0.54|2.01|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.01|0.54|0.9085
91503820|NCT02009046|182879073|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8059|TWO_SIDED|95.0|0.36|3.62|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||3.62|0.36|0.8059
91503821|NCT02009046|182879074|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6861|TWO_SIDED|95.0|0.44|1.71|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.71|0.44|0.6861
91503822|NCT02009046|182879074|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9973|TWO_SIDED||||||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|No results provided, as model would not converge.|||||0.9973
91503823|NCT02009046|182879075|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0002|TWO_SIDED|95.0|1.39|2.8|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.80|1.39|0.0002
91503824|NCT02009046|182879075|SUPERIORITY||Odds Ratio (OR)|2.71||||0.003|TWO_SIDED|95.0|1.44|5.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||5.09|1.44|0.0030
91503825|NCT00620828|182879076|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Patient cohort was inclusive of patient undergoing single TKA from June 2007 to July 2008. Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.||||<0.05
91503826|NCT00620828|182879077|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||Significant differences in Fentanyl PCA pump usage across study arms were assessed for the 4-8h,8-12h,and 12h-24h time frames.||||.05
91503827|NCT00620828|182879078|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||This analysis was performed on data collected 24-hours post-operatively for patient cohort.||||.05
91503828|NCT00620828|182879079|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort.||||.05
91503829|NCT00620828|182879080|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Straight leg raise data collected at 4-hours, 8-hours, 12-hours and 24-hours post-operatively for patient cohort.||||.05
91503830|NCT01082965|182879084|SUPERIORITY_OR_OTHER||Leasts Square (LS) Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.265||0.9742|TWO_SIDED|95.0|-0.6|0.58||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Mixed model for repeated measures (MMRM) was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, Apolipoprotein E (ApoE) genotype, site as covariates.||0.58|-0.60|0.9742
91503831|NCT01082965|182879085|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9638|TWO_SIDED|95.0|-0.51|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.51|0.9638
91503832|NCT01082965|182879086|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.153||0.2548|TWO_SIDED|95.0|-0.53|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.53|0.2548
91503833|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.057||0.6316|TWO_SIDED|95.0|-0.18|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.18|0.6316
91503834|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.063||0.6256|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.6256
91503835|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.059||0.5847|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.5847
91503836|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.123||0.1555|TWO_SIDED|95.0|-0.46|0.09||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.09|-0.46|0.1555
91503837|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.151||0.2416|TWO_SIDED|95.0|-0.51|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.51|0.2416
91503838|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.134||0.807|TWO_SIDED|95.0|-0.33|0.26||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.26|-0.33|0.8070
91503839|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.189||0.6828|TWO_SIDED|95.0|-0.59|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.59|0.6828
91503840|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.109||0.8987|TWO_SIDED|95.0|-0.26|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.26|0.8987
91503841|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.117||0.8922|TWO_SIDED|95.0|-0.28|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.28|0.8922
91503842|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.203||0.7555|TWO_SIDED|95.0|-0.39|0.52||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.52|-0.39|0.7555
91531758|NCT02886728|182939619|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-3.7|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.7|<0.001
91531759|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-8.5|-5.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.2|-8.5|<0.001
91531760|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
91503843|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.218||0.1928|TWO_SIDED|95.0|-0.18|0.79||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.79|-0.18|0.1928
91503844|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.4946|TWO_SIDED|95.0|-0.26|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.26|0.4946
91503845|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.196||0.7029|TWO_SIDED|95.0|-0.56|0.4||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.40|-0.56|0.7029
91503846|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.171||0.1085|TWO_SIDED|95.0|-0.68|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.68|0.1085
91503847|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.132||0.3588|TWO_SIDED|95.0|-0.44|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.44|0.3588
91503848|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.151||0.3053|TWO_SIDED|95.0|-0.2|0.53||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.53|-0.20|0.3053
91503849|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.9861|TWO_SIDED|95.0|-0.36|0.36||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.36|-0.36|0.9861
91531761|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|-8.8|-4.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.7|-8.8|<0.001
91748457|NCT02780856|183388954|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
91503850|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6558|TWO_SIDED|95.0|-0.41|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.41|0.6558
91503851|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.145||0.9471|TWO_SIDED|95.0|-0.53|0.51||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.51|-0.53|0.9471
91503852|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.186||0.2136|TWO_SIDED|95.0|-0.77|0.23||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.23|-0.77|0.2136
91503853|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.189||0.6435|TWO_SIDED|95.0|-0.47|0.67||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.67|-0.47|0.6435
91503854|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.086||0.0659|TWO_SIDED|95.0|-0.41|0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.02|-0.41|0.0659
91503855|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.7687|TWO_SIDED|95.0|-0.41|0.31||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.31|-0.41|0.7687
91503856|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.163||0.1061|TWO_SIDED|95.0|-0.73|0.1||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.10|-0.73|0.1061
91503857|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.3925|TWO_SIDED|95.0|-0.41|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.41|0.3925
91503858|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.161||0.1991|TWO_SIDED|95.0|-0.58|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.58|0.1991
91503859|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.151||0.5176|TWO_SIDED|95.0|-0.45|0.24||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.24|-0.45|0.5176
91503860|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.314|TWO_SIDED|95.0|-0.5|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.50|0.3140
91503861|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.6348|TWO_SIDED|95.0|-0.46|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.46|0.6348
91503862|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.165||0.1491|TWO_SIDED|95.0|-0.64|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.64|0.1491
91503863|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.192||0.4226|TWO_SIDED|95.0|-0.59|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.59|0.4226
91503864|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.228||0.9778|TWO_SIDED|95.0|-0.49|0.5||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.50|-0.49|0.9778
91503865|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.179||0.9456|TWO_SIDED|95.0|-0.4|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.40|0.9456
91503866|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2299|TWO_SIDED|95.0|-0.55|0.15||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.15|-0.55|0.2299
91503867|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.188||0.5069|TWO_SIDED|95.0|-0.54|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.54|0.5069
91503868|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.143||0.3524|TWO_SIDED|95.0|-0.45|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.45|0.3524
91503869|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.358||0.4182|TWO_SIDED|95.0|-0.8|1.47||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.47|-0.80|0.4182
91503870|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_DEVIATION|0.326||0.363|TWO_SIDED|95.0|-0.42|1.04||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.04|-0.42|0.3630
91503871|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.263||0.9837|TWO_SIDED|95.0|-0.73|0.74||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.74|-0.73|0.9837
91503872|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.102||0.0974|TWO_SIDED|95.0|-0.04|0.42||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.42|-0.04|0.0974
91503873|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.1246|TWO_SIDED|95.0|-0.04|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.04|0.1246
91503874|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.119||0.619|TWO_SIDED|95.0|-0.2|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.20|0.6190
91503875|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.635|TWO_SIDED|95.0|-0.39|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.39|0.6350
91503876|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.8205|TWO_SIDED|95.0|-0.4|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.40|0.8205
91503877|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.123||0.2959|TWO_SIDED|95.0|-0.42|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.42|0.2959
91503878|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.194||0.552|TWO_SIDED|95.0|-0.56|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.56|0.5520
91503879|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22||0.9046|TWO_SIDED|95.0|-0.5|0.45||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.45|-0.50|0.9046
91503880|NCT01082965|182879087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.125||0.0402|TWO_SIDED|95.0|-0.62|-0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||-0.02|-0.62|0.0402
91531762|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-9.9|-6.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.6|-9.9|<0.001
91503881|NCT01082965|182879088|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|12.11||0.688|TWO_SIDED|95.0|-21.82|31.82||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||31.82|-21.82|0.6880
91503882|NCT01082965|182879088|SUPERIORITY_OR_OTHER||LS Mean Difference|9.79|STANDARD_ERROR_OF_MEAN|9.143||0.3157|TWO_SIDED|95.0|-11.3|30.87||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||30.87|-11.30|0.3157
91503883|NCT01082965|182879088|SUPERIORITY_OR_OTHER||LS Mean Difference|9.86|STANDARD_ERROR_OF_MEAN|8.921||0.3228|TWO_SIDED|95.0|-13.56|33.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||33.28|-13.56|0.3228
91531763|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.2|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-8.2|<0.001
91503884|NCT01082965|182879089|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|3.479||0.254|TWO_SIDED|95.0|-12.9|4.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total IR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||4.12|-12.90|0.2540
91503885|NCT01082965|182879089|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7684|TWO_SIDED|95.0|-4.17|5.37||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total DR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||5.37|-4.17|0.7684
91503886|NCT01082965|182879090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.059||0.494|TWO_SIDED|95.0|-0.09|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.09|0.4940
91503887|NCT01082965|182879090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.057||0.1031|TWO_SIDED|95.0|-0.02|0.22||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.22|-0.02|0.1031
91531764|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.5|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-8.5|<0.001
91531765|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-8.0|-5.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-8.0|<0.001
91503888|NCT01082965|182879090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.048||0.3277|TWO_SIDED|95.0|-0.06|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.06|0.3277
91503889|NCT01082965|182879090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6585|TWO_SIDED|95.0|-0.05|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.05|0.6585
91503890|NCT01082965|182879090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.8863|TWO_SIDED|95.0|-0.07|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.07|0.8863
91503891|NCT01082965|182879090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.044||0.4388|TWO_SIDED|95.0|-0.06|0.13||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.13|-0.06|0.4388
91503892|NCT03722017|182879126|SUPERIORITY||Risk Ratio (RR)|0.91||||0.006|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.006
91503893|NCT03722017|182879126|SUPERIORITY||Risk Ratio (RR)|0.93||||0.11|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.110
91503894|NCT03722017|182879126|SUPERIORITY||Risk Ratio (RR)|0.92||||0.06|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up Timepoint||||0.060
91503895|NCT03722017|182879127|SUPERIORITY||Mean Difference (Net)|-0.049||||0.738|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.738
91748458|NCT02780856|183388954|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
91748459|NCT00378599|183389023|SUPERIORITY_OR_OTHER||Binomial Approximation|0.288|||||TWO_SIDED|95.0|0.21|0.38||||||||0.38|0.21|
91748460|NCT00322023|183389060|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|These are paired t test baseline vs final for the 30 mg/kg dose||||||<0.0001
91748461|NCT00322023|183389060|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|These are paired t test baseline vs final for the 60 mg/kg dose||||||<0.05
91748462|NCT00322023|183389060|SUPERIORITY|These are paired t test baseline vs final for the 120 mg/kg dose|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91748463|NCT00322023|183389061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|TWO_SIDED|95.0||||These are paired t test baseline vs final for 30mg/kg|t-test, 2 sided|||||||0.39
91748464|NCT00322023|183389061|SUPERIORITY||||||<|0.001||||||These are paired t test baseline vs final for 60mg/kg|t-test, 2 sided|||||||<0.001
91748465|NCT00322023|183389061|SUPERIORITY|||||||0.01||||||These are paired t test baseline vs final for 120mg/kg|t-test, 2 sided|||||||0.01
91748466|NCT03327220|183389062|SUPERIORITY||Difference in Means|1.3||||0.0841|TWO_SIDED|95.0|-0.6|3.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that true iovera° mean was greater than or equal to the true standard of care mean versus the alternative hypothesis that true iovera° mean was less than true standard of care mean.||3.2|-0.6|0.0841
91503896|NCT03722017|182879127|SUPERIORITY||Mean Difference (Net)|0.001||||0.995|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.995
91748467|NCT03327220|183389063|NON_INFERIORITY|The objective met if the t-test for non-inferiority was statistically significant using a one-sided α = 0.025 level of statistical significance.|Difference in Means|1.9|||<|0.0001|TWO_SIDED|95.0|-2.3|6.1||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that Standard of Care mean minus the iovera° mean was greater than or equal to non-inferiority margin of 14 versus alternative hypothesis that difference in means was less than 14.||6.1|-2.3|<0.0001
91748468|NCT03327220|183389064|SUPERIORITY||Difference in Means|0.5||||0.0946|TWO_SIDED|95.0|-0.2|1.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Pain in the Past 7 days - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||1.2|-0.2|0.0946
91748469|NCT03327220|183389064|SUPERIORITY|Pain Right Now - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.|Difference in Means|0.4||||0.2204|TWO_SIDED|95.0|-0.6|1.3||p-value was calculated from a one-sided, two-sample t-test,|t-test, 1 sided|||||1.3|-0.6|0.2204
91748470|NCT03327220|183389065|SUPERIORITY||Difference in Means|-0.8||||0.3231|TWO_SIDED|95.0|-4.0|2.5||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||2.5|-4.0|0.3231
91748471|NCT03920293|183389066|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.49|=|0.0009|TWO_SIDED|95.0|-2.6|-0.7||Statistical significance was tested at α=0.05.|MMRM|||||-0.7|-2.6|=0.0009
91748472|NCT00523705|183389072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|STANDARD_ERROR_OF_MEAN|4.86||0.467|TWO_SIDED||||||Regression, Linear||estimate of main effect of treatment in a linear mixed effects model.|Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.||||0.467
91748473|NCT01691885|183389089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|||<|0.001|TWO_SIDED|95.0|2.74|8.91|||ANCOVA|Analysis was performed using an ANCOVA model with covariates of treatment, baseline, period and subject as a random effect.||||8.91|2.74|<0.001
91748474|NCT01972308|183389124|SUPERIORITY||Group differences in expected 12 month c|-0.31|||||TWO_SIDED|95.0|-0.64|0.04||||||||0.04|-0.64|
91748475|NCT01972308|183389125|SUPERIORITY||Group differences in expected 12 month c|-0.66|||||TWO_SIDED|95.0|-1.38|-0.01||||||||-0.01|-1.38|
91748476|NCT01972308|183389126|SUPERIORITY||Group differences in expected 12 month c|0.06|||||TWO_SIDED|95.0|-0.33|0.43||||||||0.43|-0.33|
91748477|NCT01972308|183389127|SUPERIORITY||Group differences in expected 12 month c|0.02|||||TWO_SIDED|95.0|-0.42|0.48||||||||0.48|-0.42|
91748478|NCT01972308|183389128|SUPERIORITY||Group differences in expected 12 month c|0.04|||||TWO_SIDED|95.0|-0.1|0.19||||||||0.19|-0.10|
91748479|NCT01972308|183389129|SUPERIORITY||Group differences in expected 12 month c|0.12|||||TWO_SIDED|95.0|-0.24|0.6||||||||0.60|-0.24|
91503897|NCT03722017|182879127|SUPERIORITY||Mean Difference (Net)|0.058||||0.721|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow Up Timepoint||||0.721
91748480|NCT01562314|183389143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.821||||0.7532|TWO_SIDED|90.0|0.292|2.309|||Regression, Logistic|||||2.309|0.292|0.7532
91748481|NCT01562314|183389144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.7032|TWO_SIDED|90.0|0.419|4.04|||Regression, Logistic|||||4.040|0.419|0.7032
91748482|NCT01180036|183389163|SUPERIORITY||Risk Difference (RD)|40.0||||0.001|TWO_SIDED|95.0|24.6|55.4|||Chi-squared|||||55.4|24.6|0.001
91748483|NCT01180036|183389164|NON_INFERIORITY|With a non-inferiority margin of 15%. enrollment of 63 evaluable patients per study are is required to achieve 80% power to show that RTX is not inferior.||||||0.009|||||||Chi-squared|||||||0.009
91748484|NCT04243577|183389165|EQUIVALENCE|Margins for this test were calculated as plus or minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and were ± 3.1.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 2 sided|||For Iteration 1 testing, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
91748485|NCT04243577|183389165|EQUIVALENCE|Margins for this test were based on the absolute value of the effect size (Cohen's d) being smaller than 0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a Confidence Interval for Cohen's d.||For Iteration 2 testing again, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
91748486|NCT04243577|183389166|NON_INFERIORITY|Margin for this test was calculated as minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and was -.99.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 1 sided|||For Iteration 1 testing, we hypothesized that Signal to Noise Ratio (SNR) obtained using the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
91748487|NCT04243577|183389166|NON_INFERIORITY|Margin for this test was based on the effect size (Cohen's d) being larger than -0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a one-sided confidence bound for Cohen's d.||For Iteration 2 testing, we again hypothesized that Signal to Noise Ratio (SNR) obtained using the newer version of the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
91503898|NCT00930579|182879160|OTHER|This study used two-sided t-tests to compare changes within group- before and after metformin treatment.|Mean Difference (Final Values)|-0.006||||0.98|TWO_SIDED||||||paired t-test|||Null hypothesis: there will be no statistically significant change between the amount of Ki-67 (protein involved in cell proliferation) in participants' tumor cells before and after taking the prescribed dose of Metformin, as measured at the 5% significance level.||||0.98
91503899|NCT01046682|182879217|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon rank sum test|||Using data from a different population, ie, patients with peripheral artery disease, and a different intervention, ie, omega-3 fatty acids, 15 participants were needed per group to achieve 80% power to detect a difference in means of -3.6% (the difference between the control group mean of -0.3% and a treatment group mean of 3.3%) assuming a common standard deviation of 3.3 using a two group t-test with a 0.05 two-sided significance level. 5 patients added to each arm in case nonparametric.||||<0.05
91503900|NCT02449174|182879300|SUPERIORITY|||||||0.8958|||||||Chi-squared, Corrected|||||||0.8958
91503901|NCT02449174|182879301|SUPERIORITY|||||||0.2059|||||||Chi-squared, Corrected|||||||0.2059
91503902|NCT01520363|182879314|SUPERIORITY||Mean Difference (Net)|-1.182|STANDARD_DEVIATION|4.294||0.211|TWO_SIDED|95.0|-3.086|0.722|||t-test, 2 sided|df=21|||t= -1.291; p=.211|.722|-3.086|.211
91503903|NCT01520363|182879314|SUPERIORITY||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.67||0.949|TWO_SIDED|95.0|-1.345|1.432|||t-test, 2 sided|df=22||||1.432|-1.345|.949
91503904|NCT01520363|182879315|SUPERIORITY||Mean Difference (Final Values)|0.333|STANDARD_DEVIATION|2.456||0.541|TWO_SIDED|95.0|-0.785|1.451||df=20|t-test, 2 sided|df=20|||t=0.622; p=.541|1.451|-0.785|.541
91503905|NCT01520363|182879315|SUPERIORITY||Mean Difference (Net)|-0.042|STANDARD_DEVIATION|2.956||0.946|TWO_SIDED|95.0|-1.29|1.206||df=23|t-test, 2 sided||||t=-.069; p=0.946|1.206|-1.290|.946
91503906|NCT01520363|182879316|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_DEVIATION|3.116||0.736|TWO_SIDED|95.0|-1.609|1.154|||t-test, 2 sided|df=21|||t=-0.342; p=0.736|1.154|-1.609|.736
91503907|NCT01520363|182879316|SUPERIORITY||Mean Difference (Net)|0.409|STANDARD_DEVIATION|3.5||0.589|TWO_SIDED|95.0|-1.143|1.961|||t-test, 2 sided||||t=0.548; p=0.589|1.961|-1.143|.589
91503908|NCT01520363|182879317|SUPERIORITY||Mean Difference (Net)|-1.429|STANDARD_DEVIATION|3.203||0.05|TWO_SIDED|95.0|-2.886|0.029|||t-test, 2 sided|df=20|||t=-2.044; p=0.05|0.029|-2.886|.05
91503909|NCT01520363|182879317|SUPERIORITY||Mean Difference (Net)|0.042|STANDARD_DEVIATION|3.862||0.958|TWO_SIDED|95.0|-1.589|1.672|||t-test, 2 sided||||t=0.053; p=0.958|1.672|-1.589|0.958
91503910|NCT01520363|182879318|SUPERIORITY||Median Difference (Net)|0.227|STANDARD_DEVIATION|1.51||0.488|TWO_SIDED|95.0|-0.442|0.897|||t-test, 2 sided|df=21|||t=0.706; p=0.488|0.897|-0.442|0.488
91503911|NCT01520363|182879318|SUPERIORITY||Median Difference (Net)|0.24|STANDARD_DEVIATION|1.535||0.442|TWO_SIDED|95.0|-0.394|0.874|||t-test, 2 sided|df=24|||t=0.782; p=0.442|0.874|-0.394|0.442
91503912|NCT01520363|182879319|SUPERIORITY||Mean Difference (Net)|0.682|STANDARD_DEVIATION|2.317||0.182|TWO_SIDED|95.0|-0.346|1.709|||t-test, 2 sided|df=21|||t=1.380; p=0.182|1.709|-0.346|0.182
91503913|NCT01520363|182879319|SUPERIORITY||Mean Difference (Net)|1.16|STANDARD_DEVIATION|1.864|<|0.005|TWO_SIDED|95.0|0.391|1.929|||t-test, 2 sided|df=24|||t=3.112; p=0.005|1.929|0.391|<0.005
91503914|NCT01520363|182879320|SUPERIORITY||Mean Difference (Net)|0.091|STANDARD_DEVIATION|3.504||0.9|TWO_SIDED|95.0|-1.463|1.644|||t-test, 2 sided||||t=0.122; p=0.90|1.644|-1.463|0.90
91503915|NCT01520363|182879320|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|2.551||0.356|TWO_SIDED|95.0|-0.573|1.533|||t-test, 2 sided|df=24|||t=0.941; p=0.356|1.533|-0.573|0.356
91503916|NCT01520363|182879321|SUPERIORITY||Mean Difference (Net)|0.136|STANDARD_DEVIATION|3.06||0.836|TWO_SIDED|95.0|-1.22|1.493|||t-test, 2 sided||||t=0.209; p=0.836|1.493|-1.220|0.836
91503917|NCT01520363|182879321|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_DEVIATION|2.698||0.826|TWO_SIDED|95.0|-0.993|1.233|||t-test, 2 sided|df=24|||t=0.222; p=0.826|1.233|-0.993|0.826
91503918|NCT01520363|182879322|SUPERIORITY||Mean Difference (Net)|-3.38|STANDARD_ERROR_OF_MEAN|4.18||0.42|TWO_SIDED|95.0|-11.8|5.05|||t-test, 2 sided|||||5.05|-11.80|0.42
91503919|NCT01520363|182879323|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|2.97|<|0.73|TWO_SIDED|95.0|-7.02|4.96|||t-test, 2 sided|||||4.96|-7.02|<0.73
91503920|NCT01520363|182879324|SUPERIORITY||Mean Difference (Net)|8.4615|STANDARD_DEVIATION|32.8016||0.371|TWO_SIDED|95.0|-11.3603|28.2834|||t-test, 2 sided|df=12|||t=0.903; p=0.371|28.2834|-11.3603|0.371
91503921|NCT01520363|182879324|SUPERIORITY||Mean Difference (Net)|4.9917|STANDARD_DEVIATION|18.0163||0.358|TWO_SIDED|95.0|-6.4553|16.4387|||t-test, 2 sided|df=11|t=0.960; p=0.358|||16.4387|-6.4553|0.358
91503922|NCT01520363|182879325|SUPERIORITY||Mean Difference (Net)|3.09412|STANDARD_DEVIATION|24.06228||0.603|TWO_SIDED|95.0|-9.27756|15.4658|||t-test, 2 sided|df=16|t=0.530; p=0.603|||15.46580|-9.27756|0.603
91503923|NCT01520363|182879325|SUPERIORITY||Mean Difference (Net)|2.42857|STANDARD_DEVIATION|11.21479||0.432|TWO_SIDED|95.0|-4.04665|8.9038|||t-test, 2 sided|df=13|t=0.810; p=0.432|||8.90380|-4.04665|0.432
91503924|NCT01520363|182879326|SUPERIORITY||Mean Difference (Net)|11.765|STANDARD_DEVIATION|26.276||0.083|TWO_SIDED|95.0|-1.745|25.275|||t-test, 2 sided|df=16|||t=1.846; p=0.083|25.275|-1.745|0.083
91503925|NCT01520363|182879326|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_DEVIATION|14.378||0.073|TWO_SIDED|95.0|-0.802|15.802|||t-test, 2 sided|df=13|||t=1.952; p=0.073|15.802|-0.802|0.073
91503926|NCT01520363|182879327|SUPERIORITY||Mean Difference (Net)|3.7474|STANDARD_DEVIATION|26.711||0.549|TWO_SIDED|95.0|-9.1269|16.6217|||t-test, 2 sided|df=18|t=0.612; p=0.549|||16.6217|-9.1269|0.549
91503927|NCT01520363|182879327|SUPERIORITY||Mean Difference (Net)|0.7143|STANDARD_DEVIATION|16.5084||0.874|TWO_SIDED|95.0|-8.8174|10.246|||t-test, 2 sided|df=13|t=0.162; p=0.874|||10.2460|-8.8174|0.874
91503928|NCT01520363|182879328|SUPERIORITY||Mean Difference (Net)|3.8167|STANDARD_DEVIATION|40.2609||0.693|TWO_SIDED|95.0|-16.2046|23.8379|||t-test, 2 sided|df=17|t=0.402; p=0.693|||23.8379|-16.2046|0.693
91503929|NCT01520363|182879328|SUPERIORITY||Mean Difference (Net)|0.84|STANDARD_DEVIATION|27.8994||0.909|TWO_SIDED|95.0|-14.6102|16.2902|||t-test, 2 sided|df=14|t=0.117; p=0.909|||16.2902|-14.6102|0.909
91503930|NCT01520363|182879329|SUPERIORITY||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.64||0.21|TWO_SIDED|95.0|-2.17|0.52|||t-test, 2 sided|||||0.52|-2.17|0.21
91503931|NCT01520363|182879330|SUPERIORITY||Mean Difference (Net)|0.74|STANDARD_ERROR_OF_MEAN|0.68||0.28|TWO_SIDED|95.0|-0.66|2.15|||t-test, 2 sided|||||2.15|-0.66|0.28
91503932|NCT00973479|182879388|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91503933|NCT00973479|182879389|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91503934|NCT00973479|182879390|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
91503935|NCT00973479|182879391|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91503936|NCT00973479|182879392|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
91503937|NCT01265849|182879405|SUPERIORITY|||||||0.4051||||||For the primary efficacy measure a two-sided p-value of 0.05 or less is considered to be statistically significant in comparing the LI+CIZ+SOC treatment vs. SOC alone for superiority.|Log Rank|Log Rank statistic is based on an unstratified analysis.||The primary objective was to compare overall survival in the LI + CIZ + SOC group to that in the SOC alone group for superiority of the former.||||0.4051
91503938|NCT01265849|182879405|SUPERIORITY|||||||0.5402|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.5402
91503939|NCT01265849|182879405|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4128|TWO_SIDED|95.0|0.89|1.32|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.32|0.89|0.4128
91503940|NCT01265849|182879405|SUPERIORITY|||||||0.7181|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.7181
91503941|NCT01265849|182879405|SUPERIORITY|||||||0.948|||||||Log Rank|This log Rank p-value is based on a stratified analysis.||||||0.9480
91503942|NCT01265849|182879405|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6101|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A hazard Ratio \< 1.0 would favor LI + SOC.|||1.42|0.81|0.6101
91503943|NCT01265849|182879406|SUPERIORITY|||||||0.0478|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.0478
91748488|NCT04243577|183389167|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 1 testing, we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
91748489|NCT04243577|183389167|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 2 testing, again we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
91748490|NCT02512874|183389172|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
91748491|NCT03777709|183389206|SUPERIORITY||Mean Difference (Final Values)|1.45|STANDARD_DEVIATION|2.0|<|0.0001|TWO_SIDED|||||unadjusted p-value|Regression, Linear||A recruitment aim of 40 participants per church (16 churches, 8 per arm, mean of 5 participants per church) provides 80% power to detect a difference of 1.45 in mean LS7 score change between groups (effect size 0.73).|Effect size of 1-unit difference in mean LS7 score was based on meta-analysis indicating each unit increase in mean LS7 metrics equates to a 19% and 11% reduction in CVD and all-cause mortality, respectively. Power calculations to estimate sample size: church goal of 16 churches (8/arm), with mean 5 participants/church (40/arm) to provide 80% power to detect 1.45 difference in average LS7 score change between groups (.01 intracluster correlation, and .5 coefficient of variation of church sizes).||||<0.0001
91748492|NCT00744978|183389342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3873|TWO_SIDED|95.0|-1.37|0.53||ANCOVA model using unstructured covariance structure; Type I error rate for primary hypothesis was 5%; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.53|-1.37|0.3873
91748493|NCT00744978|183389343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.2465|TWO_SIDED|95.0|-0.39|1.49||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.49|-0.39|0.2465
91748494|NCT00744978|183389344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.2092|TWO_SIDED|95.0|-0.33|1.5||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.50|-0.33|0.2092
91748495|NCT00744978|183389345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.4339|TWO_SIDED|95.0|-1.3|0.56||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.56|-1.30|0.4339
91748496|NCT00744978|183389346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9745|TWO_SIDED|95.0|-0.26|0.27|||ANCOVA|||Difference from placebo analyzed using a mixed effects linear model with subject (nested within sequence) as a random effect, and stratum, site, period, sequence, and treatment as fixed effects.||0.27|-0.26|0.9745
91748497|NCT00744978|183389347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.2852|TWO_SIDED|95.0|-0.57|1.92||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.92|-0.57|0.2852
91748498|NCT00744978|183389348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.0468|TWO_SIDED|95.0|0.02|2.53||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||2.53|0.02|0.0468
91748499|NCT00744978|183389349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8811|TWO_SIDED|95.0|-0.02|0.03||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.03|-0.02|0.8811
91748500|NCT00744978|183389350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.083|TWO_SIDED|95.0|0.0|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.00|0.0830
91748501|NCT00744978|183389351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7226|TWO_SIDED|95.0|-0.03|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.03|0.7226
91503944|NCT01265849|182879406|SUPERIORITY|||||||0.0137|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0137
91503945|NCT01265849|182879406|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0236|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||0.95|0.48|0.0236
91503946|NCT01265849|182879406|SUPERIORITY|||||||0.4115|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.4115
91503947|NCT01265849|182879406|SUPERIORITY|||||||0.2862|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.|||This HR is presented as (LI + SOC) / SOC. A HR \< 1.0 favors LI+SOC. Wald p-value for this HR is 0.3859.|||0.2862
91503948|NCT01265849|182879406|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3859|TWO_SIDED|95.0|0.52|1.29|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.29|0.52|0.3859
91503949|NCT01265849|182879407|SUPERIORITY|||||||0.7304||||||P-values are not adjusted for multiple comparisons.|Log Rank|This Log Rank P-value is based on an unstratified analysis.||The secondary endpoint LRC failure is analyzed similar to the primary OS endpoint. The primary comparison is LI+CIZ+SOC vs SOC; LI+SOC vs SOC results are also reported.||||0.7304
91503950|NCT01265849|182879407|SUPERIORITY|||||||0.7171||||||P-values are reported unadjusted for multiplicity.|Log Rank|The Log Rank statistic is based on a stratified analysis.||||||0.7171
91503951|NCT01265849|182879407|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.802|TWO_SIDED|95.0|0.79|1.36|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.36|0.79|0.8020
91503952|NCT01265849|182879407|SUPERIORITY|||||||0.4231|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.4231
91503953|NCT01265849|182879407|SUPERIORITY|||||||0.6998|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6998
91503954|NCT01265849|182879407|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3944|TWO_SIDED|95.0|0.81|1.69|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.69|0.81|0.3944
91503955|NCT01265849|182879408|SUPERIORITY|||||||0.6142|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.6142
91748502|NCT00744978|183389352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.5588|TWO_SIDED|95.0|-6.68|3.62||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Week 1: difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.62|-6.68|0.5588
91748503|NCT00744978|183389353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.15||||0.1173|TWO_SIDED|95.0|-9.34|1.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.05|-9.34|0.1173
91748504|NCT00744978|183389354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.6251|TWO_SIDED|95.0|-6.58|3.96||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.96|-6.58|0.6251
91748505|NCT00744978|183389355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9109|TWO_SIDED|95.0|-0.05|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.05|0.9109
91748506|NCT00744978|183389356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.6632|TWO_SIDED|95.0|-0.06|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.06|0.6632
91748507|NCT00744978|183389357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.545|TWO_SIDED|95.0|-0.07|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.07|0.5450
91748508|NCT00744978|183389358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2799|TWO_SIDED|95.0|-0.02|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.02|0.2799
91748509|NCT00744978|183389359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9675|TWO_SIDED|95.0|-0.03|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo aAnalyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.03|0.9675
91748510|NCT00744978|183389360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5008|TWO_SIDED|95.0|-0.05|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.05|0.5008
91748511|NCT00744978|183389361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.2245|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.2245
91503956|NCT01265849|182879408|SUPERIORITY|||||||0.3024|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.3024
91748512|NCT00744978|183389362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.4974|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.4974
91748513|NCT00744978|183389363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8525|TWO_SIDED|95.0|-0.02|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.02|0.8525
91748514|NCT02379988|183389373|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.0063||||||P-value for Free breathing and Breath Holding Heart Mean|Wilcoxon (Mann-Whitney)|||||||=0.0063
91748515|NCT02379988|183389373|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Free breathing and Breath Holding Lung Mean|Wilcoxon (Mann-Whitney)|||||||=0 .0110
91748516|NCT02379988|183389373|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.5098||||||P-value for Free breathing and Breath Holding LAD Mean|Wilcoxon (Mann-Whitney)|||||||=0.5098
91748517|NCT02379988|183389374|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.001||||||P-value for Heart Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0010
91748518|NCT02379988|183389374|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Lung Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0110
91748519|NCT02379988|183389375|EQUIVALENCE|Paired T-test|||||=|0.01||||||P-value for Large breast volume group|Paired T-test|||||||=0.01
91503957|NCT01265849|182879408|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.42082|TWO_SIDED|95.0|0.55|1.28|||Regression, Cox||A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.28|0.55|0.42082
91748520|NCT02379988|183389375|EQUIVALENCE|Paired T-test|||||=|0.1||||||P-value for Small breast volume group|Paired T-test|||||||=0.10
91748521|NCT02379988|183389376|EQUIVALENCE|Wilcoxon test was used due to the non-normal distribution of the data|||||=|0.7776|||||||Wilcoxon (Mann-Whitney)|||||||=0.7776
91748522|NCT02089464|183389379|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
91748523|NCT02089464|183389380|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
91748524|NCT02089464|183389381|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91748525|NCT02089464|183389382|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91748526|NCT02089464|183389383|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91748527|NCT02089464|183389385|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
91503958|NCT01265849|182879408|SUPERIORITY|||||||0.9784|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.9784
91503959|NCT01265849|182879408|SUPERIORITY|||||||0.8461||||||This Log Rank statistic is based on a stratified analysis.|Log Rank|||||||0.8461
91503960|NCT01265849|182879408|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8131|TWO_SIDED|95.0|0.53|1.65|||Regression, Cox||A Hazard Ratio of \< 1.0 would favor LI + SOC.|||1.65|0.53|0.8131
91748528|NCT02089464|183389386|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
91748529|NCT02089464|183389387|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
91748530|NCT04262882|183389399|SUPERIORITY||Odds Ratio (OR)|1.67||||0.2|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|Adjusted for age and religion. Analysis in GEE to account for dependence in repeated, dyadic data.|Reference group is the comparator arm|||3.64|0.77|0.20
91748531|NCT04262882|183389402|SUPERIORITY||Wald Chi-Square|35.2|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.|||||<0.001
91748532|NCT04262882|183389402|SUPERIORITY||unstandardized beta|0.41|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748533|NCT04262882|183389402|SUPERIORITY||unstandardized beta|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748534|NCT04262882|183389403|SUPERIORITY||Wald Chi-Square|64.53|||<|0.001|TWO_SIDED|||||Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.||"Tests of significance for each follow-up time point:~7-months: unstandardized beta=1.08, standard error=0.14, p \< 0.001; 10-months: unstandardized beta=0.79, standard error=0.14, p \< 0.001"|||<0.001
91748535|NCT04262882|183389403|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91503961|NCT01265849|182879409|SUPERIORITY|||||||0.3303|||||||Log Rank|This Log Rank statistic is from an unstratified analysis.||This secondary endpoint PFS is analyzed similar to OS and LRC.||||0.3303
91748536|NCT04262882|183389403|SUPERIORITY||unstandardized beta|0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748537|NCT04262882|183389404|SUPERIORITY||Wald Chi-Square|23.89|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748538|NCT04262882|183389404|SUPERIORITY||unstandardized beta|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748539|NCT04262882|183389404|SUPERIORITY||unstandardized beta|0.19|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748540|NCT04262882|183389405|SUPERIORITY||Wald Chi-Square|48.26|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models were run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748541|NCT04262882|183389405|SUPERIORITY||unstandardized beta|0.68|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Cox|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748542|NCT04262882|183389405|SUPERIORITY||unstandardized beta|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.04
91748543|NCT04262882|183389406|SUPERIORITY||Wald Chi-Square|9.87||||0.007|TWO_SIDED|||||Arm\*Time p value for 10-months follow up overall.|Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.007
91503962|NCT01265849|182879409|SUPERIORITY|||||||0.6669|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6669
91503963|NCT01265849|182879409|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3728|TWO_SIDED|95.0|0.9|1.31|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.31|0.90|0.3728
91748544|NCT04262882|183389406|SUPERIORITY|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|unstandardized beta|-0.16|STANDARD_ERROR_OF_MEAN|0.32||0.6|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|||||||0.60
91748545|NCT04262882|183389406|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
91748546|NCT04262882|183389407|SUPERIORITY||Wald Chi-Square|10.42||||0.005|TWO_SIDED||||||Regression, Logistic|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.005
91748547|NCT04262882|183389407|SUPERIORITY||Odds Ratio (OR)|1.36||||0.05|TWO_SIDED|95.0|0.99|1.85||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.85|0.99|0.05
91748548|NCT04262882|183389407|SUPERIORITY||Odds Ratio (OR)|0.96||||0.71|TWO_SIDED|95.0|0.75|1.22||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.22|0.75|0.71
91748549|NCT04262882|183389408|SUPERIORITY||Wald Chi-Square|13.4||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
91748550|NCT04262882|183389408|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
91503964|NCT01265849|182879409|SUPERIORITY|||||||0.5739|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5739
91503965|NCT01265849|182879409|SUPERIORITY|||||||0.8162|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.8162
91503966|NCT01265849|182879409|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.4728|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.43|0.84|0.4728
91503967|NCT01265849|182879410|SUPERIORITY|||||||0.1797|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.1797
91503968|NCT01265849|182879410|SUPERIORITY|||||||0.0159|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0159
91748551|NCT04262882|183389408|SUPERIORITY||unstandardized beta|0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748552|NCT04262882|183389409|SUPERIORITY||Wald Chi-Square|78.81||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
91503969|NCT01265849|182879410|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0896|TWO_SIDED|95.0|0.55|1.04|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio of \< 1.0 would favor LI + CIZ + SOC.|||1.04|0.55|0.0896
91503970|NCT01265849|182879410|SUPERIORITY|||||||0.5175|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5175
91503971|NCT01265849|182879410|SUPERIORITY|||||||0.453|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.4530
91503972|NCT01265849|182879410|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4376|TWO_SIDED|95.0|0.54|1.3|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.30|0.54|0.4376
91503973|NCT01265849|182879411|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.395||0.21|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|Approximately 30% of participants completed the QOL instrument at first administration (Month2), thus the study did not have the power for QoL comparisons. These completer analyses are descriptive only.||||0.2100
91748553|NCT04262882|183389409|SUPERIORITY||unstandardized beta|1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91503974|NCT01265849|182879411|SUPERIORITY||Mean Difference (Net)|4.67|STANDARD_ERROR_OF_MEAN|3.401||0.1701|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|Approximately 30% of participants completed the QOL instrument at last administration (Month 36), thus the study did not have power for QoL comparisons. These completer analyses are descriptive only.||||0.1701
91503975|NCT01265849|182879412|SUPERIORITY|This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Median Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.397||0.5871|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|LI + CIZ + SOC, Standard of Care (SOC)||||0.5871
91503976|NCT01265849|182879412|SUPERIORITY||Mean Difference (Net)|4.46|STANDARD_ERROR_OF_MEAN|3.247||0.17|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.1700
91748554|NCT04262882|183389409|SUPERIORITY||unstandardized beta|1.65|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
91748555|NCT04262882|183389410|SUPERIORITY||Wald Chi-Square|19.46|||<|0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748556|NCT04262882|183389410|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.008
91748557|NCT04262882|183389410|SUPERIORITY||unstandardized beta|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
91748558|NCT02950155|183389416|SUPERIORITY||probability ratio|2.48||||0.007|TWO_SIDED|95.0|1.2|5.11|||Fisher Exact|||The primary end-point was analyzed as an intention-to-treat analysis, with Fisher's exact test of the difference in proportion, with α=0·05 to indicate statistically significant difference||5.11|1.20|0.007
91748559|NCT02950155|183389417|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.79|TWO_SIDED|95.0|-4.4|2.1|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||2.1|-4.4|0.79
91503977|NCT01265849|182879413|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|2.183||0.6296|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6296
91503978|NCT01265849|182879413|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|3.103||0.7454|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7454
91503979|NCT01265849|182879413|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.465||0.7452|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.7452
91748560|NCT02950155|183389418|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.3|0.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||0.8|-3.3|0.34
91503980|NCT01265849|182879413|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.496||0.771|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7710
91503981|NCT01265849|182879414|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|2.185||0.6337|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6337
91503982|NCT01265849|182879414|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.962||0.945|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.9450
91531766|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.5|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.5|<0.001
91531767|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.4|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-7.4|<0.001
91531768|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-5.9|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-5.9|<0.001
91503983|NCT01265849|182879414|SUPERIORITY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.465||0.4071|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI+ CIZ + SOC.|||||0.4071
91503984|NCT01265849|182879414|SUPERIORITY||Mean Difference (Net)|-7.29|STANDARD_ERROR_OF_MEAN|3.347||0.0296|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.0296
91503985|NCT01265849|182879415|SUPERIORITY|Statistical tests were for a significant treatment effect in the Cox Proportional Hazards model including treatment, disease stage, tumor location, and geographical region.|% of significant test results|21.6|||<|0.05|TWO_SIDED|95.0|17.0|26.9||"Under the null hypothesis of no effect the expected number of significant test results would be balanced between treatments.~The expected number (%) of statistically significant results would be approximately 14 (5%) of 282."|Regression, Cox|||"Treatment comparisons of LI+CIZ+SOC v. SOC were repeated at all levels of HP, HP ratios, and HP combinations for endpoints OS, PFS, and LRC.~Significant outcomes for the treatment term in the model (two-sided p\<0.05) were accumulated."||26.9|17.0|<0.05
91503986|NCT01265849|182879416|SUPERIORITY||Percent (%) of Participants|8.1|||<|0.0001|TWO_SIDED|95.0|5.6|11.2|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||11.2|5.6|<.0001
91531769|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.6|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.6|<0.001
91531770|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-4.9|-1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.9|-4.9|<0.001
91748561|NCT02950155|183389419|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.47|TWO_SIDED|95.0|-8.2|3.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||3.8|-8.2|0.47
91748562|NCT02950155|183389420|SUPERIORITY||probability ratio|1.89||||0.036|TWO_SIDED|95.0|1.04|3.44|||Fisher Exact|||||3.44|1.04|0.036
91748563|NCT00468676|183389427|SUPERIORITY_OR_OTHER||scaled marginal model parameter|-1.57|STANDARD_ERROR_OF_MEAN|0.28||0.001|TWO_SIDED|95.0|-2.12|-1.02||Significance of the four outcome composite|Scaled Marginal Model||Intervention group had significantly lower scaled marginal mean scores than usual care|||-1.02|-2.12|.001
91503987|NCT01265849|182879416|SUPERIORITY||Percent (%) of Participants|9.7|||<|0.0001|TWO_SIDED|95.0|4.7|14.7|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||14.7|4.7|<0.0001
91503988|NCT01265849|182879417|SUPERIORITY||Percent (%) of Participants|15.2|||<|0.0001|TWO_SIDED|95.0|9.6|20.8|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||20.8|9.6|<0.0001
91503989|NCT01265849|182879417|SUPERIORITY||Percent (%) of Participants|18.5|||<|0.0001|TWO_SIDED|95.0|8.2|28.9|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||28.9|8.2|<0.0001
91531771|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.8|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-3.8|<0.001
91531772|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.74||0.23|TWO_SIDED|95.0|-2.4|0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.6|-2.4|0.23
91531773|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.6|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-3.6|0.005
91531774|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.6|-5.0|<0.001
91748564|NCT00468676|183389428|SUPERIORITY_OR_OTHER||Slope|0.01|||<|0.01||95.0|||||general estimating equations|||Disability outcomes were measured at six and 12 months after randomization using linear regression models adjusted for baseline values. The disability models combined information across time points and were estimated using general estimating equations to account for correlation. All analyses were based on intent to treat principles||||<0.01
91748565|NCT00468676|183389430|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.26|-0.56|<0.001
91503990|NCT01265849|182879418|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI + CIZ + SOC.||||0.0007
91503991|NCT01265849|182879418|SUPERIORITY|||||||0.0434|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative that response is predictive of increased survival in subjects receiving LI + SOC.||||0.0434
91748566|NCT00468676|183389431|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-3.4|||||TWO_SIDED|95.0|-6.9|0.1|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||0.1|-6.9|
91503992|NCT01265849|182879418|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.||||<0.0001
91531775|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.73||0.021|TWO_SIDED|95.0|-3.1|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-3.1|0.021
91531776|NCT02886728|182939620|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-4.3|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.3|<0.001
91531777|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|7.6||||0.006|TWO_SIDED|95.0|2.2|12.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||12.9|2.2|0.006
91531778|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|4.9||||0.16|TWO_SIDED|95.0|-1.8|11.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||11.6|-1.8|0.16
91531779|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|7.6||||0.029|TWO_SIDED|95.0|1.1|14.1||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||14.1|1.1|0.029
91748567|NCT00468676|183389432|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-9.1|||||TWO_SIDED|95.0|-17.5|-0.8|||Regression, Linear||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a linear-regression model predicting a 12-month outcome.|||-0.8|-17.5|
91503993|NCT01265849|182879419|SUPERIORITY|||||||0.0101|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + CIZ + SOC.||||0.0101
91503994|NCT01265849|182879419|SUPERIORITY|||||||0.4843|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + SOC.||||0.4843
91503995|NCT01265849|182879419|SUPERIORITY||||||<|0.0067||||||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.|Fisher Exact|||||||<0.0067
91503996|NCT01265849|182879420|SUPERIORITY||Hazard Ratio (HR)|0.348||||0.0131|TWO_SIDED|95.0|0.152|0.801|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI (combined arms LI + CIZ + SOC, LI + SOC) is \>=1.0 versus the alternative hypothesis that subjects responding to LI are at reduced risk of death (HR \< 1.0).||0.801|0.152|0.0131
91503997|NCT01265849|182879420|SUPERIORITY||Hazard Ratio (HR)|0.246||||0.0181|TWO_SIDED|95.0|0.077|0.787|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI + CIZ + SOC is \>=1.0 versus the alternative hypothesis that subjects responding to LI + CIZ + SOC are at reduced risk of death (HR \< 1.0).||0.787|0.077|0.0181
91503998|NCT01154218|182879421|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.56|||||TWO_SIDED|90.0|91.49|108.33||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.33|91.49|
91748568|NCT00468676|183389433|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.56|||||TWO_SIDED|95.0|-0.85|-0.27|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.27|-0.85|
91503999|NCT01154218|182879421|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|106.93|||||TWO_SIDED|90.0|98.26|116.35||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||116.35|98.26|
91504000|NCT01154218|182879421|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|85.76|||||TWO_SIDED|90.0|78.88|93.25||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.25|78.88|
91504001|NCT01154218|182879422|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|99.6|||||TWO_SIDED|90.0|91.3|108.66||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.66|91.30|
91504002|NCT01154218|182879422|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|107.56|||||TWO_SIDED|90.0|98.58|117.35||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.35|98.58|
91504003|NCT01154218|182879422|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|85.52|||||TWO_SIDED|90.0|78.45|93.22||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.22|78.45|
91504004|NCT01154218|182879425|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|106.97|||||TWO_SIDED|90.0|96.55|118.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.51|96.55|
91504005|NCT01154218|182879425|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.32|||||TWO_SIDED|90.0|100.47|123.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||123.33|100.47|
91504006|NCT01154218|182879425|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|86.22|||||TWO_SIDED|90.0|77.89|95.43||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||95.43|77.89|
91504007|NCT01154218|182879428|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.03|||||TWO_SIDED|90.0|90.16|110.97||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.97|90.16|
91504008|NCT01154218|182879428|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.85|||||TWO_SIDED|90.0|98.11|120.77||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.77|98.11|
91748569|NCT03569748|183389434|NON_INFERIORITY|Margin=0.04|Proportion Difference|0.1342||||0.0051|TWO_SIDED|95.0|0.0014|0.2671|||Chi-squared, Corrected|||H0: P1-P2 ≤ -Margin||0.2671|0.0014|0.0051
91748570|NCT03569748|183389435|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
91748571|NCT03569748|183389436|SUPERIORITY||Percentage Difference|14.2||||0.0003|TWO_SIDED||||||Chi-squared, Corrected|||||||0.0003
91504009|NCT01154218|182879428|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|74.87|||||TWO_SIDED|90.0|67.55|82.98||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||82.98|67.55|
91504010|NCT01154218|182879429|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.08|||||TWO_SIDED|90.0|90.46|110.73||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.73|90.46|
91531780|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|8.1||||0.015|TWO_SIDED|95.0|1.6|14.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||14.6|1.6|0.015
91504011|NCT01154218|182879429|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.47|||||TWO_SIDED|90.0|98.03|120.02||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.02|98.03|
91504012|NCT01154218|182879429|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|76.59|||||TWO_SIDED|90.0|69.23|84.74||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||84.74|69.23|
91748572|NCT02979093|183389441|SUPERIORITY||Mean Difference (Final Values)|0.1697|STANDARD_ERROR_OF_MEAN|0.1025||0.106|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Happy Own vs. Happy Unknown||||0.106
91504013|NCT01154218|182879430|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|102.11|||||TWO_SIDED|90.0|92.84|112.31||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.31|92.84|
91504014|NCT01154218|182879430|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.87|||||TWO_SIDED|90.0|98.98|119.75||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.75|98.98|
91504015|NCT01154218|182879430|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|71.94|||||TWO_SIDED|90.0|65.46|79.05||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||79.05|65.46|
91504016|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0631|TWO_SIDED|95.0|-5.96|0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.16|-5.96|0.0631
91504017|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.0008|TWO_SIDED|95.0|-8.33|-2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.20|-8.33|0.0008
91504018|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0188|TWO_SIDED|95.0|-6.73|-0.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.61|-6.73|0.0188
91504019|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.8|-2.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.63|-8.80|0.0003
91504020|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0177|TWO_SIDED|95.0|-6.77|-0.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.65|-6.77|0.0177
91504021|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.855||95.0|-2.72|3.27||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.27|-2.72|0.8550
91531781|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|4.2||||0.33|TWO_SIDED|95.0|-3.9|12.2||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||12.2|-3.9|0.33
91748573|NCT02979093|183389441|SUPERIORITY||Mean Difference (Final Values)|0.20458|STANDARD_ERROR_OF_MEAN|0.1101||0.0709|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for the Amygdala: Happy Own vs. Happy Unknown infant faces.||||0.0709
91748574|NCT02979093|183389441|SUPERIORITY||Mean Difference (Final Values)|-0.14559|STANDARD_ERROR_OF_MEAN|0.08546||0.0964|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Sad Own vs. Sad Unknown infant faces.||||0.0964
91748575|NCT02979093|183389441|SUPERIORITY||Mean Difference (Final Values)|-0.15755|STANDARD_ERROR_OF_MEAN|0.07914||0.0538|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Amygdala: Sad Own vs. Sad Unknown infant faces.||||0.0538
91504022|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1719|TWO_SIDED|95.0|-5.08|0.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.91|-5.08|0.1719
91504023|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7469|TWO_SIDED|95.0|-3.49|2.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.50|-3.49|0.7469
91504024|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1001|TWO_SIDED|95.0|-5.55|0.49||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.49|-5.55|0.1001
91531782|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|10.2||||0.013|TWO_SIDED|95.0|2.5|17.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||17.9|2.5|0.013
91531783|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|3.6||||0.074|TWO_SIDED|95.0|-0.3|7.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||7.6|-0.3|0.074
91531784|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|1.9||||0.49|TWO_SIDED|95.0|-3.1|6.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||6.9|-3.1|0.49
91531785|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|4.4||||0.075|TWO_SIDED|95.0|-0.2|8.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||8.9|-0.2|0.075
91531786|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.3|16.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||16.2|4.3|<0.001
91531787|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|7.9||||0.045|TWO_SIDED|95.0|0.7|15.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||15.2|0.7|0.045
91531788|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|6.5||||0.1|TWO_SIDED|95.0|-1.1|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||14.0|-1.1|0.100
91531789|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|10.0||||0.004|TWO_SIDED|95.0|3.2|16.7||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||16.7|3.2|0.004
91504025|NCT00362115|182879432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7294|TWO_SIDED|95.0|-3.52|2.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.47|-3.52|0.7294
91748576|NCT02979093|183389442|SUPERIORITY||Mean Difference (Final Values)|0.09778|STANDARD_ERROR_OF_MEAN|0.09687||0.319|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (Addiction vs. Control) and condition (Oxytocin \[OT\] vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs. placebo for Ventromedial prefrontal cortex (vmPFC) for happy own vs. happy unknown infant faces."||||0.319
91748577|NCT02979093|183389442|SUPERIORITY||Mean Difference (Final Values)|-0.15289|STANDARD_ERROR_OF_MEAN|0.10968||0.171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for vmPFC for Happy Own vs. Happy Unknown infant faces."||||0.171
91504026|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0111|TWO_SIDED|95.0|-10.84|-1.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.41|-10.84|0.0111
91531790|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|5.5||||0.25|TWO_SIDED|95.0|-2.9|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||14.0|-2.9|0.25
91531791|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|6.5||||0.14|TWO_SIDED|95.0|-2.0|15.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||15.0|-2.0|0.14
91531792|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|7.5||||0.002|TWO_SIDED|95.0|2.8|12.3||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||12.3|2.8|0.002
91531793|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|8.2||||0.008|TWO_SIDED|95.0|2.9|13.6||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||13.6|2.9|0.008
91531794|NCT02886728|182939621|SUPERIORITY||Difference in Response Rates|2.5||||0.47|TWO_SIDED|95.0|-3.9|8.9||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||8.9|-3.9|0.47
91504027|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.51|-6.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.08|-15.51|< 0.0001
91504028|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||<|0.0001|TWO_SIDED|95.0|-14.53|-5.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.10|-14.53|< 0.0001
91504029|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.02|-7.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.52|-17.02|< 0.0001
91504030|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5||||0.0005|TWO_SIDED|95.0|-13.19|-3.76||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.76|-13.19|0.0005
91504031|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.2768|TWO_SIDED|95.0|-2.06|7.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.17|-2.06|0.2768
91504032|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.3688|TWO_SIDED|95.0|-6.74|2.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.51|-6.74|0.3688
91504033|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1||||0.6293|TWO_SIDED|95.0|-5.75|3.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.48|-5.75|0.6293
91504034|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.1298|TWO_SIDED|95.0|-8.25|1.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.06|-8.25|0.1298
91504035|NCT00362115|182879433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9315|TWO_SIDED|95.0|-4.41|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.41|0.9315
91504036|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0016|TWO_SIDED|95.0|-13.17|-3.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.09|-13.17|0.0016
91504037|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-15.17|-5.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.09|-15.17|< 0.0001
91504038|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.0001|TWO_SIDED|95.0|-17.8|-7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.72|-17.80|< 0.0001
91504039|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.36|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-16.36|< 0.0001
91504040|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7|||<|0.0001|TWO_SIDED|95.0|-15.75|-5.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.63|-15.75|< 0.0001
91504041|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9909|TWO_SIDED|95.0|-4.96|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-4.96|0.9909
91504042|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4213|TWO_SIDED|95.0|-6.96|2.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.92|-6.96|0.4213
91504043|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.0646|TWO_SIDED|95.0|-9.59|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-9.59|0.0646
91504044|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.2107|TWO_SIDED|95.0|-8.15|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-8.15|0.2107
91504045|NCT00362115|182879434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.3059|TWO_SIDED|95.0|-7.54|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.54|0.3059
91504046|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1653|TWO_SIDED|95.0|-5.69|0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.98|-5.69|0.1653
91504047|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.0151|TWO_SIDED|95.0|-7.5|-0.81||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.81|-7.50|0.0151
91504048|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.048|TWO_SIDED|95.0|-6.7|-0.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.03|-6.70|0.0480
91504049|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0098|TWO_SIDED|95.0|-7.81|-1.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.08|-7.81|0.0098
91504050|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0113|TWO_SIDED|95.0|-7.68|-0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.98|-7.68|0.0113
91504051|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.3416|TWO_SIDED|95.0|-1.68|4.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.84|-1.68|0.3416
91504052|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8973|TWO_SIDED|95.0|-3.49|3.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.06|-3.49|0.8973
91504053|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7292|TWO_SIDED|95.0|-2.69|3.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.84|-2.69|0.7292
91504054|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7646|TWO_SIDED|95.0|-3.79|2.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.79|-3.79|0.7646
91504055|NCT00362115|182879435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8133|TWO_SIDED|95.0|-3.67|2.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.88|-3.67|0.8133
91504056|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-12.51|-4.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.51|-12.51|< 0.0001
91504057|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0001|TWO_SIDED|95.0|-17.31|-8.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.90|-17.31|< 0.0001
91504058|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.27|-7.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.95|-16.27|< 0.0001
91504059|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.0001|TWO_SIDED|95.0|-21.07|-12.46||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.46|-21.07|< 0.0001
91748578|NCT02979093|183389442|SUPERIORITY||Mean Difference (Final Values)|-0.20839|STANDARD_ERROR_OF_MEAN|0.08405||0.0179|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs placebo for Dorsolateral Prefrontal Cortex (dlPFC) for Sad Own vs. Sad Unknown infant faces."||||0.0179
91504060|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-17.58|-9.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.17|-17.58|< 0.0001
91504061|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.3735|TWO_SIDED|95.0|-2.1|5.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.58|-2.10|0.3735
91504062|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.1668|TWO_SIDED|95.0|-6.91|1.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-6.91|0.1668
91504063|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.3629|TWO_SIDED|95.0|-5.86|2.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.15|-5.86|0.3629
91504064|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0022|TWO_SIDED|95.0|-10.67|-2.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.36|-10.67|0.0022
91504065|NCT00362115|182879436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1303|TWO_SIDED|95.0|-7.18|0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-7.18|0.1303
91504066|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||<|0.0001|TWO_SIDED|95.0|-8.12|-2.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.72|-8.12|< 0.0001
91504067|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.65|-11.33|< 0.0001
91504068|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-11.52|< 0.0001
91504069|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-13.73|-7.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.91|-13.73|< 0.0001
91504070|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-12.31|-6.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-12.31|< 0.0001
91504071|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1249|TWO_SIDED|95.0|-0.56|4.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.61|-0.56|0.1249
91504072|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.4542|TWO_SIDED|95.0|-3.79|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-3.79|0.4542
91504073|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.3574|TWO_SIDED|95.0|-3.97|1.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.44|-3.97|0.3574
91504074|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0184|TWO_SIDED|95.0|-6.18|-0.57||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.57|-6.18|0.0184
91504075|NCT00362115|182879437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.145|TWO_SIDED|95.0|-4.77|0.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.70|-4.77|0.1450
91748579|NCT02979093|183389442|SUPERIORITY||Mean Difference (Final Values)|0.04315|STANDARD_ERROR_OF_MEAN|0.11827||0.7171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for dlPFC for Sad Own vs. Sad Unknown infant faces."||||0.7171
91748580|NCT00522418|183389443|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||F Test|||||||.01
91748581|NCT00522418|183389446|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
91748582|NCT00522418|183389449|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
91748583|NCT00522418|183389450|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||F-Test|||||||0.28
91748584|NCT00522418|183389451|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||F-Test|||||||0.03
91748585|NCT00522418|183389452|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||F-Test|||||||0.26
91748586|NCT02438683|183389466|OTHER||Slope|0.0029|||||TWO_SIDED|95.0|0.0012|0.0046||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected HR change from baseline (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis).||0.0046|0.0012|
91748587|NCT02438683|183389467|OTHER||Mean Difference (Net)|3.85|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|90.0|0.73|6.97||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||6.97|0.73|
91748588|NCT02438683|183389468|OTHER||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|1.69|8.16||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.16|1.69|
91748589|NCT02438683|183389469|OTHER||Slope|0.0011|||||TWO_SIDED|95.0|-0.0009|0.003||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected QTcF change from baseline (ddQTcF) and independent variable. Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject (Primary analysis). The covariance structure is No diagonal Factor Analytic FA0(2).||0.0030|-0.0009|
91748590|NCT02438683|183389470|OTHER||Mean Difference (Net)|4.54|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|3.39|5.7||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||5.70|3.39|
91748591|NCT02438683|183389471|OTHER||Mean Difference (Net)|4.73|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|90.0|1.34|8.13||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.13|1.34|
91748592|NCT02438683|183389472|OTHER||Slope|0.0054|||||TWO_SIDED|95.0|0.0032|0.0076||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected max HR (dHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis)||0.0076|0.0032|
91748593|NCT02438683|183389473|OTHER||Slope|-0.0014|||||TWO_SIDED|95.0|-0.0036|0.0008||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||0.0008|-0.0036|
91748594|NCT02438683|183389473|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0029|||||TWO_SIDED|95.0|-0.0052|-0.0007||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||-0.0007|-0.0052|
91748595|NCT01926041|183389483|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.48|0.84||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||0.84|0.48|0.008
91748596|NCT01926041|183389484|SUPERIORITY||Cox Proportional Hazard|1.85||||0.023|TWO_SIDED|95.0|1.13|3.04||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||3.04|1.13|0.023
91748597|NCT01926041|183389490|OTHER||Beta Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
91748598|NCT00147017|183389504|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
91748599|NCT00147017|183389505|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
91748600|NCT00147017|183389506|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
91748601|NCT05032690|183389525|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|99.17|||||TWO_SIDED|90.0|93.72|104.93|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||104.93|93.72|
91504076|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9||||0.0009|TWO_SIDED|95.0|-12.46|-3.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.26|-12.46|0.0009
91504077|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-18.46|-8.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.77|-18.46|< 0.0001
91504078|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.63|-17.21|< 0.0001
91504079|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.83|-12.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.92|-22.83|< 0.0001
91504080|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.52|-8.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.84|-18.52|< 0.0001
91504081|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9424|TWO_SIDED|95.0|-4.25|4.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.58|-4.25|0.9424
91504082|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0189|TWO_SIDED|95.0|-10.26|-0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.93|-10.26|0.0189
91531795|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|2.4|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.4|<0.001
91504083|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0612|TWO_SIDED|95.0|-9.01|0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.21|-9.01|0.0612
91504084|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.63|-5.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.07|-14.63|< 0.0001
91504085|NCT00362115|182879438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0175|TWO_SIDED|95.0|-10.33|-1.0||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.00|-10.33|0.0175
91504086|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0108|TWO_SIDED|95.0|-7.26|-0.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.95|-7.26|0.0108
91504087|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||<|0.0001|TWO_SIDED|95.0|-11.16|-4.55||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-11.16|< 0.0001
91504088|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.82|-5.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.26|-11.82|< 0.0001
91504089|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.98|-7.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-13.98|< 0.0001
91504090|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-12.52|< 0.0001
91504091|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.306|TWO_SIDED|95.0|-1.45|4.59||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.59|-1.45|0.3060
91531796|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|0.7|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.7|0.001
91504092|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.1823|TWO_SIDED|95.0|-5.37|1.02||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.02|-5.37|0.1823
91504093|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0751|TWO_SIDED|95.0|-6.01|0.29||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.29|-6.01|0.0751
91504094|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0034|TWO_SIDED|95.0|-8.18|-1.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.64|-8.18|0.0034
91504095|NCT00362115|182879439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0306|TWO_SIDED|95.0|-6.72|-0.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.33|-6.72|0.0306
91504096|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0061|TWO_SIDED|95.0|-13.9|-2.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.33|-13.90|0.0061
91504097|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5||||0.0002|TWO_SIDED|95.0|-17.56|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-17.56|0.0002
91504098|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-18.34|-6.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-18.34|< 0.0001
91504099|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.0001|TWO_SIDED|95.0|-23.75|-11.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.34|-23.75|< 0.0001
91504100|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.86|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-19.86|< 0.0001
91504101|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.9355|TWO_SIDED|95.0|-5.74|5.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.28|-5.74|0.9355
91504102|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.2223|TWO_SIDED|95.0|-9.41|2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.20|-9.41|0.2223
91504103|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1328|TWO_SIDED|95.0|-10.19|1.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.35|-10.19|0.1328
91504104|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7||||0.0016|TWO_SIDED|95.0|-15.61|-3.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.70|-15.61|0.0016
91504105|NCT00362115|182879440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0437|TWO_SIDED|95.0|-11.7|-0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.17|-11.70|0.0437
91531797|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.3|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.3|<0.001
91748602|NCT05032690|183389525|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|135.9|||||TWO_SIDED|90.0|109.28|169.01|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||169.01|109.28|
91748603|NCT05032690|183389526|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|93.77|||||TWO_SIDED|90.0|90.08|97.61|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||97.61|90.08|
91748604|NCT05032690|183389526|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|162.54|||||TWO_SIDED|90.0|130.25|202.84|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted"||202.84|130.25|
91748605|NCT05032690|183389527|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|98.21|||||TWO_SIDED|90.0|93.83|102.8|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||102.80|93.83|
91748606|NCT05032690|183389527|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|146.7|||||TWO_SIDED|90.0|117.88|182.58|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||182.58|117.88|
91748607|NCT00487942|183389534|SUPERIORITY_OR_OTHER||Effect size|-0.04|||||TWO_SIDED|95.0|-0.81|0.73||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.81|
91748608|NCT00487942|183389534|SUPERIORITY_OR_OTHER||Effect size|0.09|||||TWO_SIDED|95.0|-0.68|0.86||Inferential statistics were not performed|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.68|
91504106|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0417|TWO_SIDED|95.0|-8.39|-0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-8.39|0.0417
91504107|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0053|TWO_SIDED|95.0|-10.44|-1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.84|-10.44|0.0053
91504108|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8||||0.0004|TWO_SIDED|95.0|-12.12|-3.56||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.56|-12.12|0.0004
91504109|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.16|-13.97|< 0.0001
91504110|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.6|-5.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-13.60|< 0.0001
91504111|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6372|TWO_SIDED|95.0|-2.97|4.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.85|-2.97|0.6372
91504112|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.6588|TWO_SIDED|95.0|-5.05|3.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.20|-5.05|0.6588
91748609|NCT00487942|183389534|SUPERIORITY_OR_OTHER||Effect size|0.15|||||TWO_SIDED|95.0|-0.66|0.95||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.95|-0.66|
91504113|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2082|TWO_SIDED|95.0|-6.72|1.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.47|-6.72|0.2082
91748610|NCT00487942|183389535|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.8|0.83||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.80|
91504114|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0437|TWO_SIDED|95.0|-8.57|-0.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.12|-8.57|0.0437
91748611|NCT00487942|183389535|SUPERIORITY_OR_OTHER||Effect size|0.31|||||TWO_SIDED|95.0|-0.51|1.14||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.14|-0.51|
91504115|NCT00362115|182879441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0495|TWO_SIDED|95.0|-8.19|-0.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.01|-8.19|0.0495
91504116|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4||||0.0007|TWO_SIDED|95.0|-14.74|-3.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.97|-14.74|0.0007
91504117|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-19.02|-7.73||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.73|-19.02|< 0.0001
91504118|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0003|TWO_SIDED|95.0|-16.0|-4.83||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.83|-16.00|0.0003
91504119|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.3|||<|0.0001|TWO_SIDED|95.0|-23.11|-11.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.47|-23.11|< 0.0001
91504120|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-18.01|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-18.01|< 0.0001
91504121|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.2594|TWO_SIDED|95.0|-2.17|8.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||8.01|-2.17|0.2594
91504122|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.6859|TWO_SIDED|95.0|-6.46|4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.26|-6.46|0.6859
91504123|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.4898|TWO_SIDED|95.0|-3.43|7.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.15|-3.43|0.4898
91504124|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.076|TWO_SIDED|95.0|-10.55|0.53||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.53|-10.55|0.0760
91504125|NCT00362115|182879442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-5.44|5.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.21|-5.44|0.9647
91504126|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.13|-3.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.43|-11.13|0.0002
91504127|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.01|-6.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.97|-15.01|< 0.0001
91504128|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.59|-4.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.64|-12.59|< 0.0001
91504129|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-17.79|-9.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.50|-17.79|< 0.0001
91504130|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.69|-4.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.70|-12.69|< 0.0001
91504131|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.279|TWO_SIDED|95.0|-1.63|5.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.62|-1.63|0.2790
91504132|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3772|TWO_SIDED|95.0|-5.53|2.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-5.53|0.3772
91748612|NCT00487942|183389535|SUPERIORITY_OR_OTHER||Effect size|0.16|||||TWO_SIDED|95.0|-0.66|0.98||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.66|
91504133|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7302|TWO_SIDED|95.0|-3.11|4.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.43|-3.11|0.7302
91504134|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0302|TWO_SIDED|95.0|-8.31|-0.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.42|-8.31|0.0302
91504135|NCT00362115|182879443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7644|TWO_SIDED|95.0|-3.22|4.38||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.38|-3.22|0.7644
91504136|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.4||||0.0001|TWO_SIDED|95.0|-12.7|-4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.19|-12.70|0.0001
91504137|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.19|-9.24||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.24|-18.19|< 0.0001
91504138|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.0001|TWO_SIDED|95.0|-16.66|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-16.66|< 0.0001
91504139|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.51|-13.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.35|-22.51|< 0.0001
91504140|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.21|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-18.21|< 0.0001
91504141|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.6905|TWO_SIDED|95.0|-3.26|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-3.26|0.6905
91504142|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0433|TWO_SIDED|95.0|-8.76|-0.13||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.13|-8.76|0.0433
91504143|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1736|TWO_SIDED|95.0|-7.22|1.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.31|-7.22|0.1736
91504144|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7||||0.0001|TWO_SIDED|95.0|-13.08|-4.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.23|-13.08|0.0001
91504145|NCT00362115|182879444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.0429|TWO_SIDED|95.0|-8.77|-0.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANOVA|||||-0.14|-8.77|0.0429
91504146|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0009|TWO_SIDED|95.0|-7.77|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-7.77|0.0009
91504147|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.32||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.32|-11.33|< 0.0001
91504148|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.63|-5.67||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.67|-11.63|< 0.0001
91504149|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-14.34|-8.18||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.18|-14.34|< 0.0001
91504150|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||<|0.0001|TWO_SIDED|95.0|-12.37|-6.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-12.37|< 0.0001
91504151|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.2068|TWO_SIDED|95.0|-0.98|4.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.50|-0.98|0.2068
91504152|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.2622|TWO_SIDED|95.0|-4.56|1.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.25|-4.56|0.2622
91504153|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.173|TWO_SIDED|95.0|-4.85|0.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.88|-4.85|0.1730
91504154|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0025|TWO_SIDED|95.0|-7.56|-1.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.62|-7.56|0.0025
91504155|NCT00362115|182879445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0681|TWO_SIDED|95.0|-5.6|0.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.20|-5.60|0.0681
91504156|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0004|TWO_SIDED|95.0|-13.28|-3.87||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.87|-13.28|0.0004
91504157|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.26|-7.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.42|-17.26|< 0.0001
91504158|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.51|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-16.51|< 0.0001
91504159|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.38|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-19.38|< 0.0001
91504160|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.53|-7.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.70|-17.53|< 0.0001
91504161|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.1479|TWO_SIDED|95.0|-1.17|7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.72|-1.17|0.1479
91504162|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8382|TWO_SIDED|95.0|-5.16|4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.19|-5.16|0.8382
91504163|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9317|TWO_SIDED|95.0|-4.42|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.42|0.9317
91504164|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.3169|TWO_SIDED|95.0|-7.29|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.29|0.3169
91504165|NCT00362115|182879446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7488|TWO_SIDED|95.0|-5.44|3.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.91|-5.44|0.7488
91504166|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.0001|TWO_SIDED|95.0|-9.98|-3.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.40|-9.98|< 0.0001
91504167|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-12.76|-5.86||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.86|-12.76|< 0.0001
91504168|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.05|-5.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-12.05|< 0.0001
91504169|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.0001|TWO_SIDED|95.0|-13.92|-6.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-13.92|< 0.0001
91504170|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.0001|TWO_SIDED|95.0|-13.11|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-13.11|< 0.0001
91504171|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.4188|TWO_SIDED|95.0|-1.83|4.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.40|-1.83|0.4188
91504172|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4255|TWO_SIDED|95.0|-4.62|1.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.95|-4.62|0.4255
91504173|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6869|TWO_SIDED|95.0|-3.91|2.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.58|-3.91|0.6869
91504174|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1678|TWO_SIDED|95.0|-5.77|1.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.01|-5.77|0.1678
91504175|NCT00362115|182879447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3132|TWO_SIDED|95.0|-4.96|1.6||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.60|-4.96|0.3132
91504176|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.0005|TWO_SIDED|95.0|-12.48|-3.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.52|-12.48|0.0005
91504177|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.24|-5.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.93|-15.24|< 0.0001
91504178|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.7|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-14.70|< 0.0001
91504179|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||<|0.0001|TWO_SIDED|95.0|-17.95|-8.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.42|-17.95|< 0.0001
91504180|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.74|-7.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-16.74|< 0.0001
91531798|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.7|4.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.8|2.7|<0.001
91504181|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8103|TWO_SIDED|95.0|-4.79|3.75||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.75|-4.79|0.8103
91504182|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1702|TWO_SIDED|95.0|-7.57|1.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.34|-7.57|0.1702
91504183|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2504|TWO_SIDED|95.0|-7.02|1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.84|-7.02|0.2504
91504184|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0144|TWO_SIDED|95.0|-10.28|-1.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.14|-10.28|0.0144
91504185|NCT00362115|182879448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0402|TWO_SIDED|95.0|-9.06|-0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.21|-9.06|0.0402
91504186|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.0014|TWO_SIDED|95.0|-8.41|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.41|0.0014
91504187|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.82|-4.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.22|-10.82|< 0.0001
91504188|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.0001|TWO_SIDED|95.0|-11.51|-4.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.93|-11.51|< 0.0001
91504189|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||<|0.0001|TWO_SIDED|95.0|-12.49|-5.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.72|-12.49|< 0.0001
91504190|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|||<|0.0001|TWO_SIDED|95.0|-10.87|-4.3||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.30|-10.87|< 0.0001
91504191|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.5519|TWO_SIDED|95.0|-2.11|3.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.95|-2.11|0.5519
91504192|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3938|TWO_SIDED|95.0|-4.54|1.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.79|-4.54|0.3938
91504193|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1949|TWO_SIDED|95.0|-5.21|1.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.07|-5.21|0.1949
91504194|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0732|TWO_SIDED|95.0|-6.21|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-6.21|0.0732
91504195|NCT00362115|182879449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3669|TWO_SIDED|95.0|-4.59|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-4.59|0.3669
91504196|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0019|TWO_SIDED|95.0|-14.94|-3.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-14.94|0.0019
91504197|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0008|TWO_SIDED|95.0|-16.15|-4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.26|-16.15|0.0008
91504198|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.004|TWO_SIDED|95.0|-14.88|-2.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.85|-14.88|0.0040
91504199|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6||||0.0001|TWO_SIDED|95.0|-18.96|-6.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-18.96|0.0001
91504200|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.0004|TWO_SIDED|95.0|-16.85|-4.89||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.89|-16.85|0.0004
91504201|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.3499|TWO_SIDED|95.0|-8.39|2.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.98|-8.39|0.3499
91504202|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.2115|TWO_SIDED|95.0|-9.61|2.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.14|-9.61|0.2115
91504203|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.4279|TWO_SIDED|95.0|-8.34|3.54||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.54|-8.34|0.4279
91504204|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0566|TWO_SIDED|95.0|-12.41|0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.17|-12.41|0.0566
91504205|NCT00362115|182879450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1435|TWO_SIDED|95.0|-10.3|1.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.50|-10.30|0.1435
91504206|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.1162|TWO_SIDED|95.0|-6.16|0.68||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.68|-6.16|0.1162
91504207|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.2494|TWO_SIDED|95.0|-5.69|1.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.48|-5.69|0.2494
91504208|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.4247|TWO_SIDED|95.0|-5.01|2.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.12|-5.01|0.4247
91504209|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.3007|TWO_SIDED|95.0|-5.79|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-5.79|0.3007
91531799|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.66||0.008|TWO_SIDED|95.0|0.5|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|0.5|0.008
91531800|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.66||0.023|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.023
91504210|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1195|TWO_SIDED|95.0|-6.67|0.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.77|-6.67|0.1195
91531801|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.59||0.003|TWO_SIDED|95.0|0.6|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.6|0.003
91504211|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2032|TWO_SIDED|95.0|-5.76|1.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.23|-5.76|0.2032
91504212|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3787|TWO_SIDED|95.0|-5.27|2.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.01|-5.27|0.3787
91504213|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5967|TWO_SIDED|95.0|-4.59|2.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.64|-4.59|0.5967
91504214|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.4345|TWO_SIDED|95.0|-5.36|2.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.31|-5.36|0.4345
91504215|NCT00362115|182879451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1954|TWO_SIDED|95.0|-6.24|1.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.28|-6.24|0.1954
91504216|NCT02188589|182879460|EQUIVALENCE|The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p\<0.05.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91504217|NCT00003641|182879469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964|TWO_SIDED||||||Log Rank|stratified on the stratification factors used for randomization||||||0.964
91504218|NCT00003641|182879470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|TWO_SIDED||||||Log Rank|Stratified on the stratification factors used for randomization||||||0.558
91504219|NCT00878709|182879485|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.008|TWO_SIDED|95.0|0.49|0.9|||Log Rank|The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.90|0.49|0.008
91531802|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.71||0.38|TWO_SIDED|95.0|-0.8|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.8|0.38
91504220|NCT00878709|182879487|SUPERIORITY||Hazard Ratio (HR)|0.952||||0.6914|TWO_SIDED|95.0|0.747|1.212|||Log Rank|||The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.212|0.747|0.6914
91504221|NCT00878709|182879488|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.||0.83|0.45|
91504222|NCT00878709|182879490|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.||1.05|0.52|
91504223|NCT00878709|182879492|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.||1.04|0.51|
91504224|NCT00878709|182879496|OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.92||The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Log Rank||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.92|0.57|0.008
91504225|NCT00878709|182879498|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.56|0.89|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||0.89|0.56|
91504226|NCT00878709|182879499|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.01|0.6|
91504227|NCT00878709|182879500|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.03|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.03|0.60|
91504228|NCT00768300|182879502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66||P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.|Log Rank||The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.|||2.66|1.14|0.010
91531803|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.59|TWO_SIDED|95.0|-1.0|1.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.8|-1.0|0.59
91748613|NCT00487942|183389536|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
91748614|NCT00487942|183389536|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.86|0.66||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.66|-0.86|
91504229|NCT00768300|182879504|SUPERIORITY_OR_OTHER||Point estimate|4.29||||0.086|TWO_SIDED|95.0|-0.805|9.376||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||9.376|-0.805|0.086
91504230|NCT00768300|182879505|SUPERIORITY_OR_OTHER||Point estimate|2.85||||0.25|TWO_SIDED|95.0|-2.2|7.9||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||7.90|-2.20|0.250
91504231|NCT00768300|182879506|SUPERIORITY_OR_OTHER||Point estimate|16.0||||0.15|TWO_SIDED|95.0|-5.0|37.0||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||37.00|-5.00|0.150
91504232|NCT00768300|182879509|SUPERIORITY_OR_OTHER||Point estimate|0.5||||0.793|TWO_SIDED|95.0|0.0|1.0||The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).|Wilcoxon (Mann-Whitney)||The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect|||1.00|0.00|0.793
91504233|NCT03011307|182879524|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in score on a scale|0.1||||0.75|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.2|0|0.75
91504234|NCT03011307|182879525|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|0.1||||0.057|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||0.2|0.0|0.057
91504235|NCT03011307|182879526|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in Daily Steps|-402.0||||0.41|TWO_SIDED|95.0|-1358.0|553.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||553|-1358|0.41
91504236|NCT03011307|182879527|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|344.0|||<|0.001|TWO_SIDED|95.0|173.0|515.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Slope Difference|||"The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.~The slope is the number of daily steps divided by the natural log of time in days."||515|173|<0.001
91504237|NCT03011307|182879528|SUPERIORITY|A likelihood-ratio test for change in World Health Organization Disability Assessment Score 2.0 value was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference: score on a scale|-5.9||||0.002|TWO_SIDED|95.0|-9.5|-2.3||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline World Health Organization Disability Assessment Score 2.0 value, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-2.3|-9.5|0.002
91748615|NCT00487942|183389536|SUPERIORITY_OR_OTHER||Effect size|0.49|||||TWO_SIDED|95.0|-0.31|1.28||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.28|-0.31|
91513392|NCT01047683|182898445|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.3||||0.6768|TWO_SIDED|95.0|-12.9|8.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||8.1|-12.9|0.6768
91748616|NCT00487942|183389537|SUPERIORITY_OR_OTHER||Effect Size|-0.27|||||TWO_SIDED|95.0|-1.03|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.03|
91513393|NCT01047683|182898445|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|5.2||||0.3022|TWO_SIDED|95.0|-5.4|15.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||15.6|-5.4|0.3022
91531804|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|1.6|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.6|<0.001
91531805|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.76||0.11|TWO_SIDED|95.0|-0.3|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.3|0.11
91748617|NCT00487942|183389537|SUPERIORITY_OR_OTHER||Effect Size|0.11|||||TWO_SIDED|95.0|-0.65|0.88||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.65|
91748618|NCT00487942|183389537|SUPERIORITY_OR_OTHER||Effect Size|-0.18|||||TWO_SIDED|95.0|-0.97|0.6||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.60|-0.97|
91748619|NCT00487942|183389538|SUPERIORITY_OR_OTHER||Effect Size|-0.32|||||TWO_SIDED|95.0|-1.08|0.44||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.44|-1.08|
91748620|NCT00487942|183389538|SUPERIORITY_OR_OTHER||Effect Size|-0.02|||||TWO_SIDED|95.0|-0.77|0.74||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.77|
91748621|NCT00487942|183389538|SUPERIORITY_OR_OTHER||Effect Size|-0.1|||||TWO_SIDED|95.0|-0.89|0.68||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.89|
91748622|NCT00487942|183389539|SUPERIORITY_OR_OTHER||Effect Size|0.15|||||TWO_SIDED|95.0|-0.61|0.9||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.90|-0.61|
91748623|NCT00487942|183389539|SUPERIORITY_OR_OTHER||Effect Size|0.25|||||TWO_SIDED|95.0|-0.5|1.01||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.50|
91748624|NCT00487942|183389539|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.34|1.25||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.25|-0.34|
91748625|NCT00487942|183389540|SUPERIORITY_OR_OTHER||Effect Size|0.45|||||TWO_SIDED|95.0|-0.33|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.33|
91748626|NCT00487942|183389540|SUPERIORITY_OR_OTHER||Effect Size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
91531806|NCT02886728|182939623|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.76||0.071|TWO_SIDED|95.0|-0.17|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.17|0.071
91748627|NCT00487942|183389540|SUPERIORITY_OR_OTHER||Effect Size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.68|
91748628|NCT00487942|183389541|SUPERIORITY_OR_OTHER||Effect Size|0.39|||||TWO_SIDED|95.0|-0.37|1.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.37|
91504238|NCT03011307|182879529|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|1.5||||0.001|TWO_SIDED|95.0|0.6|2.4||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||2.4|0.6|0.001
91504239|NCT03011307|182879530|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|0.00035||||0.537|TWO_SIDED|95.0|-0.00085|0.0015||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Intercept difference: Opioid probability|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.0015|-.00085|0.537
91504240|NCT03011307|182879531|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference: Opioid probability|-0.166||||0.01|TWO_SIDED|95.0|-0.172|-0.16||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-0.160|-0.172|0.010
91504241|NCT03011307|182879532|SUPERIORITY||Mean Difference (Net)|3.0|STANDARD_DEVIATION|14.0||0.55|TWO_SIDED||||||Regression, Linear|||Scores were compared statistically at baseline and 2 months between groups using a generalized linear model with time as a fixed factor.||||.55
91504242|NCT03011307|182879533|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.2||0.46|TWO_SIDED||||||Regression, Linear|||Groups were compared over time from baseline to 2 months using a generalized linear model with time as a fixed factor.||||0.46
91504243|NCT03011307|182879534|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.84||0.38|TWO_SIDED||||||Regression, Linear|||Groups were compared between preoperative and 2 month postoperative sessions using linear regression with time as a fixed factor.||||0.38
91504244|NCT00877058|182879535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.05|TWO_SIDED|95.0|0.15|0.48|||Chi-squared|||||0.48|0.15|<0.05
91504245|NCT00877058|182879535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.001|TWO_SIDED|0.05|0.24|0.68|||Chi-squared|||||0.68|0.24|0.001
91504246|NCT00877058|182879536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||<|0.05|TWO_SIDED|95.0|0.96|2.52|||Chi-squared|||||2.52|0.96|<0.05
91504247|NCT00877058|182879536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.05|TWO_SIDED|95.0|0.79|2.08|||Chi-squared|||||2.08|0.79|<0.05
91504248|NCT00877058|182879537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.31|0.97|||Chi-squared|||||0.97|0.31|<0.05
91504249|NCT00877058|182879537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||<|0.05|TWO_SIDED|95.0|0.33|1.02|||Chi-squared|||||1.02|0.33|<0.05
91504250|NCT00567892|182879538|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-6.0|4.0||All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|Wilcoxon signed rank test|Since the assumptions of parametric tests were not met we used non-parametric tests for the analysis.||The null hypothesis for this study was the difference between the change in THI score due to active rTMS treatment and the change in THI score due to rTMS sham was not different from 0.||4|-6|0.944
91504251|NCT00567892|182879538|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.674|TWO_SIDED|95.0|-9.0|10.0|||Wilcoxon signed rank test|The assumptions of parametric tests were not met.|All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|The null hypothesis for this study was the difference between the change in THI score due to 4 weeks active rTMS treatment and the change in THI score due to 4 weeks rTMS sham was not different from 0.||10|-9|0.674
91504252|NCT01344161|182879546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.001|TWO_SIDED|95.0|||||ANCOVA|An analysis of covariance (ANCOVA) was used to adjust mean differences on all variables.||||||0.001
91504253|NCT00525174|182879614|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|||Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline \<= +4 letters for E-ETDRS testing).||||0.02
91504254|NCT00525174|182879615|NON_INFERIORITY_OR_EQUIVALENCE|The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|Mean Difference (Net)|0.38|||||ONE_SIDED|95.0||0.76|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.||0.76||
91504255|NCT00525174|182879615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.09|TWO_SIDED|95.0|-0.06|0.83|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.||0.83|-0.06|0.09
91748629|NCT00487942|183389541|SUPERIORITY_OR_OTHER||Effect Size|-0.05|||||TWO_SIDED|95.0|-0.81|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.81|
91504256|NCT00525174|182879615|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity.||||0.20
91504257|NCT00525174|182879615|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye.||||0.49
91504258|NCT00525174|182879615|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model.||||0.21
91504259|NCT00525174|182879617|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.||||0.27
91504260|NCT00525174|182879618|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.||||0.86
91504261|NCT00525174|182879618|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Cox|||The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.||||0.28
91504262|NCT00525174|182879619|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.||||0.61
91504263|NCT00525174|182879622|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.90
91504264|NCT00525174|182879623|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.88
91504265|NCT00525174|182879625|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.||||0.07
91504266|NCT00525174|182879625|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.||||0.21
91504267|NCT00525174|182879626|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.||||0.03
91504268|NCT00525174|182879627|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.||||<0.001
91504269|NCT00525174|182879628|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.||||0.90
91504270|NCT00525174|182879629|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.||||0.01
91504271|NCT00525174|182879630|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.||||0.12
91504272|NCT00525174|182879631|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.||||0.001
91504273|NCT00525174|182879632|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.||||<0.001
91504274|NCT00525174|182879633|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.||||<0.001
91504275|NCT04254978|182879647|SUPERIORITY||||||<|0.0001|||||||Exact binomial distribution|||Comparison of the true response rate of bomedemstat to a fixed efficacy target of 5%: Null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||||<.0001
91513394|NCT01047683|182898446|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.7|||<|0.0001|TWO_SIDED|95.0|-25.0|-11.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-11.3|-25.0|<0.0001
91748630|NCT00487942|183389541|SUPERIORITY_OR_OTHER||Effect Size|-0.01|||||TWO_SIDED|95.0|-0.8|0.77||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.77|-0.80|
91748631|NCT00487942|183389542|SUPERIORITY_OR_OTHER||Effect Size|-0.99|||||TWO_SIDED|95.0|-1.79|-0.19||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.19|-1.79|
91748632|NCT00487942|183389542|SUPERIORITY_OR_OTHER||Effect Size|-0.66|||||TWO_SIDED|95.0|-1.44|0.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.11|-1.44|
91748633|NCT00487942|183389542|SUPERIORITY_OR_OTHER||Effect Size|-0.03|||||TWO_SIDED|95.0|-0.82|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.82|
91748634|NCT00487942|183389543|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
91748635|NCT00487942|183389543|SUPERIORITY_OR_OTHER||Effect Size|0.08|||||TWO_SIDED|95.0|-0.68|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.68|
91504276|NCT02310919|182879665|NON_INFERIORITY|For the non-inferiority hypothesis testing of the primary outcome, a one-sided 95% CI was constructed for the relative risk. The alternative trigger will be considered non-inferior to the standard trigger if the lower bound of the one-sided CI of the relative risk is not less than 0.8 (i.e. risk reduction limit of 20%).|Risk Ratio (RR)|0.91|||||ONE_SIDED|95.0|0.83|||Using the standard trigger as the reference, the relative risk (i.e. risk ratio) (RR) with 95% confidence interval (CI) for the probability of the outcome was calculated using log-binomial regression models with application of GEE.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The alternative trigger will be considered non-inferior to the standard hCG trigger if it is at least 80% as effective at inducing oocyte competence. Considering a cluster size of 15 oocytes and an estimated intra-cluster correlation of 0.1, we calculated that approximately 50 participants were needed in each study arm when the non-inferiority difference is -0.1 (i.e. 20% of 0.5 total competent proportion) with a power of 0.8 and a one-sided alpha of 0.05.|||0.83|
91504277|NCT02310919|182879666|SUPERIORITY||Risk Ratio (RR)|0.85||||0.06|TWO_SIDED|95.0|0.71|1.01||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in number of oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.01|0.71|0.06
91504278|NCT02310919|182879667|SUPERIORITY||Risk Ratio (RR)|0.87||||0.13|TWO_SIDED|95.0|0.72|1.04||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function.|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the number of MII oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.04|0.72|0.13
91504279|NCT02310919|182879668|SUPERIORITY||Risk Ratio (RR)|0.97||||0.47|TWO_SIDED|95.0|0.9|1.05||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in oocyte maturity rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.05|0.90|0.47
91504280|NCT02310919|182879669|SUPERIORITY||Risk Ratio (RR)|0.88||||0.01|TWO_SIDED|95.0|0.76|0.97||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||0.97|0.76|0.01
91531807|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|1.6|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.6|<0.001
91531808|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.7||0.032|TWO_SIDED|95.0|0.1|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.1|0.032
91748636|NCT00487942|183389543|SUPERIORITY_OR_OTHER||Effect Size|0.81|||||TWO_SIDED|95.0|0.0|1.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.63|-0.00|
91504281|NCT02310919|182879670|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.9|1.1||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in ICSI fertilization rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.10|0.90|0.95
91504282|NCT02310919|182879671|SUPERIORITY||Risk Ratio (RR)|0.95||||0.52|TWO_SIDED|95.0|0.81|1.12||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the percentage of high quality cleavage-stage embryos between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.12|0.81|0.52
91504283|NCT02310919|182879672|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.84|1.16||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||1.16|0.84|0.87
91531809|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.0|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.0|<0.001
91504284|NCT02310919|182879673|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.59|1.74||The statistical significance was based on a two-sided alpha of 0.05.|Fisher Exact||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in livebirths in fresh transfers between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.74|0.59|1.0
91504285|NCT02310919|182879674|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in bloating scores from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.98
91504286|NCT02310919|182879675|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in abdominal circumference from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.39
91504287|NCT02310919|182879676|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in body weight from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.41
91748637|NCT00487942|183389544|SUPERIORITY_OR_OTHER||Effect Size|-0.39|||||TWO_SIDED|95.0|-1.16|0.37||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.37|-1.16|
91504288|NCT02310919|182879677|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504289|NCT02310919|182879678|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504290|NCT02310919|182879679|SUPERIORITY|||||||0.08||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
91504291|NCT02310919|182879680|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504292|NCT02310919|182879681|SUPERIORITY|||||||0.67||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.67
91504293|NCT02310919|182879682|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504294|NCT02310919|182879683|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504295|NCT02310919|182879684|SUPERIORITY|||||||0.49||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.49
91504296|NCT02310919|182879685|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504297|NCT02310919|182879686|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504298|NCT02310919|182879687|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91748638|NCT00487942|183389544|SUPERIORITY_OR_OTHER||Effect Size|-0.45|||||TWO_SIDED|95.0|-1.21|0.31||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.31|-1.21|
91504299|NCT02310919|182879688|SUPERIORITY|||||||0.16||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.16
91504300|NCT02310919|182879689|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504301|NCT02310919|182879690|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91504302|NCT02310919|182879691|SUPERIORITY|||||||0.95||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.95
91504303|NCT02310919|182879692|SUPERIORITY|||||||0.07||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.07
91504304|NCT02310919|182879693|SUPERIORITY|||||||0.66||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.66
91748639|NCT00487942|183389544|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-0.99|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-0.99|
91748640|NCT00487942|183389545|SUPERIORITY_OR_OTHER||Effect Size|0.47|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
91531810|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.6||0.023|TWO_SIDED|95.0|0.2|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|0.2|0.023
91748641|NCT00487942|183389545|SUPERIORITY_OR_OTHER||Effect Size|0.28|||||TWO_SIDED|95.0|-0.48|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.48|
91504305|NCT03244865|182879694|NON_INFERIORITY|Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.|||||<|0.1||||||Pilot Study|t-test, 2 sided|||There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.||||<.1
91504306|NCT00277212|182879696|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.552||||0.058|TWO_SIDED|95.0|0.296|1.03||stratified Log-Rank test, controlling for type of index mood episode|Log Rank||Cox's proportional hazards model, with type of index modd episode as stratification factor, and randomized treatment group as covariate.|||1.030|0.296|0.058
91504307|NCT00277212|182879697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.671||||0.055|TWO_SIDED|95.0|0.446|1.011||p-value for equality of survival curves|Log Rank|stratified log-rank test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.011|0.446|0.055
91504308|NCT00277212|182879698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784||||0.381|TWO_SIDED|95.0|0.454|1.354||p-value for equality of survival curves|Log Rank|stratified log-rank test, conrolling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.354|0.454|0.381
91504309|NCT00277212|182879699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.871||||0.295|TWO_SIDED|95.0|0.672|1.128||p-value for equality of survival curves|Log Rank|stratified Log-Rank Test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.128|0.672|0.295
91504310|NCT00277212|182879701|SUPERIORITY_OR_OTHER||Treatement Difference|2.24||||0.001|TWO_SIDED|95.0|0.91|3.57||ANOVA (main effects=double-blind treatment, covariate=index mood episode) used for baseline comparisons. ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons|ANCOVA||Aripiprazole vs. placebo|Week 52 LOCF||3.57|0.91|0.001
91748642|NCT00487942|183389545|SUPERIORITY_OR_OTHER||Effect size|0.14|||||TWO_SIDED|95.0|-0.64|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.64|
91504311|NCT00277212|182879702|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.56||||0.073|TWO_SIDED|95.0|0.29|1.07|||Cochran-Mantel-Haenszel||aripiprazole/placebo|Week 52 LOCF||1.07|0.29|0.073
91504312|NCT00277212|182879702|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Cochran-Mantel-Haenszel|||At Any Time||||0.194
91504313|NCT00277212|182879703|SUPERIORITY_OR_OTHER||relative risk|3.41||||0.007|TWO_SIDED|95.0|1.3|8.94|||Cochran-Mantel-Haenszel|||Week 52 LOCF||8.94|1.30|0.007
91504314|NCT00277212|182879703|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91504315|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.467|TWO_SIDED|95.0|-2.37|1.09||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA model, with double-blind treatment as main effects and index mood episode as covariate, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||1.09|-2.37|0.467
91504316|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|-0.06|0.78||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 12||0.78|-0.06|
91504317|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|0.19|1.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||1.30|0.19|
91504318|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.08|1.86||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||1.86|0.08|
91513395|NCT01047683|182898446|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.1||||0.0182|TWO_SIDED|95.0|-15.1|-1.4|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.4|-15.1|0.0182
91504319|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-0.08|1.92||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||1.92|-0.08|
91504320|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.001|TWO_SIDED|95.0|0.31|1.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||1.26|0.31|0.001
91748643|NCT00487942|183389546|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-0.99|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-0.99|
91748644|NCT00487942|183389546|SUPERIORITY_OR_OTHER||Effect size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
91748645|NCT00487942|183389546|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.72|0.85||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.85|-0.72|
91748646|NCT00487942|183389547|SUPERIORITY_OR_OTHER||Effect size|-0.2|||||TWO_SIDED|95.0|-0.95|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-0.95|
91748647|NCT00487942|183389547|SUPERIORITY_OR_OTHER||Effect size|-0.35|||||TWO_SIDED|95.0|-1.11|0.41||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.41|-1.11|
91748648|NCT00487942|183389547|SUPERIORITY_OR_OTHER||Effect size|-0.16|||||TWO_SIDED|95.0|-0.95|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.95|
91748649|NCT00487942|183389548|SUPERIORITY_OR_OTHER||Effect size|-0.51|||||TWO_SIDED|95.0|-1.3|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.30|
91748650|NCT00487942|183389548|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.25|1.35||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.35|-0.25|
91504321|NCT00277212|182879704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.002|TWO_SIDED|95.0|0.23|1.04||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from baseline||1.04|0.23|0.002
91504322|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.971|TWO_SIDED|95.0|-0.35|0.34||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, with double-blind treatment as main effects, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||0.34|-0.35|0.971
91531811|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.74||0.065|TWO_SIDED|95.0|-0.1|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|-0.1|0.065
91504323|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.03|0.51||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 8||0.51|-0.03|
91504324|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.60|-0.13|
91504325|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.06|0.55||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.55|-0.06|
91531812|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.74||0.15|TWO_SIDED|95.0|-0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.4|0.15
91531813|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.73|TWO_SIDED|95.0|-1.0|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.0|0.73
91531814|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.37|TWO_SIDED|95.0|-0.8|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.8|0.37
91504326|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-0.06|0.65||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.65|-0.06|
91504327|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.095|TWO_SIDED|95.0|-0.04|0.52||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.52|-0.04|0.095
91504328|NCT00277212|182879710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.061|TWO_SIDED|95.0|-0.01|0.63||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripirazole - placebo|Highest change from Baseline||0.63|-0.01|0.061
91531815|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.78||0.83|TWO_SIDED|95.0|-1.7|1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.4|-1.7|0.83
91504329|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.458||95.0|-0.25|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, controlling for treatment, is used for baseline estimates.|aripiprazole - placebo|Baseline||0.11|-0.25|0.458
91531816|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.66||0.073|TWO_SIDED|95.0|-0.1|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.1|0.073
91531817|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.09|TWO_SIDED|95.0|-0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.2|0.090
91748651|NCT00487942|183389548|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
91748652|NCT00487942|183389549|SUPERIORITY_OR_OTHER||Effect size|-0.64|||||TWO_SIDED|95.0|-1.43|0.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.15|-1.43|
91748653|NCT00487942|183389549|SUPERIORITY_OR_OTHER||Effect Size|-0.26|||||TWO_SIDED|95.0|-1.05|0.53||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.53|-1.05|
91748654|NCT00487942|183389549|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
91748655|NCT00487942|183389550|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.92|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.92|
91748656|NCT00487942|183389550|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.54|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.54|
91748657|NCT00487942|183389550|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.12|0.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.49|-1.12|
91748658|NCT00487942|183389551|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.22|0.33||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.33|-1.22|
91748659|NCT00487942|183389551|SUPERIORITY_OR_OTHER||Effect size|-0.89|||||TWO_SIDED|95.0|-1.69|-0.08||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.08|-1.69|
91748660|NCT00487942|183389551|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.95|0.7||Inferential statistics not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.95|
91748661|NCT00487942|183389597|SUPERIORITY_OR_OTHER||Effect size|0.12|||||TWO_SIDED|95.0|-0.76|1.0||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.0|-0.76|
91504330|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.05|0.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.26|-0.05|
91504331|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.11|0.2||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.20|-0.11|
91504332|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|0.0|0.42||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.42|0.00|
91504333|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at week 52||0.16|-0.05|
91504334|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.515|TWO_SIDED|95.0|-0.22|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||0.11|-0.22|0.515
91531818|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.68|TWO_SIDED|95.0|-1.9|1.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.2|-1.9|0.68
91748662|NCT00487942|183389597|SUPERIORITY_OR_OTHER||Effect size|-0.33|||||TWO_SIDED|95.0|-1.15|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.15|
91748663|NCT00487942|183389597|SUPERIORITY_OR_OTHER||Effect size|0.27|||||TWO_SIDED|95.0|-0.61|1.15||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.61|
91748664|NCT00487942|183389598|SUPERIORITY_OR_OTHER||Effect size|0.33|||||TWO_SIDED|95.0|-0.58|1.24||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.24|-0.58|
91748665|NCT00487942|183389598|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.91|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.91|
91748666|NCT00487942|183389598|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.33|0.45||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.33|
91748667|NCT00487942|183389599|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.75|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.75|
91513396|NCT03447769|182898447|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.258|TWO_SIDED|95.0|0.78|1.14||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|||1.14|0.78|0.258
91513397|NCT03447769|182898452|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.676|TWO_SIDED|95.0|0.76|1.58||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 \<1%||1.58|0.76|0.676
91531819|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.3|TWO_SIDED|95.0|-0.6|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.6|0.30
91504335|NCT00277212|182879711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.73|TWO_SIDED|95.0|-0.16|0.23||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.23|-0.16|0.730
91504336|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2||Means, mean differences, 95% confidence intervals for the differences, and the p-values are based on ANOVA/ANCOVA model.|ANOVA|ANOVA, controlling for treatment, used for baseline estimates.|aripiprazole - placebo|Baseline||0.20|-0.08|0.435
91504337|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|0.04|0.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.30|0.04|
91504338|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.11|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 24||0.17|-0.11|
91748668|NCT00487942|183389599|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.98|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.98|
91504339|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||0.13|-0.13|
91513398|NCT03447769|182898452|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.036|TWO_SIDED|95.0|0.34|1.05||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥1% and \<49%||1.05|0.34|0.036
91513399|NCT03447769|182898452|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.823|TWO_SIDED|95.0|0.73|2.43||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥50%||2.43|0.73|0.823
91513400|NCT03447769|182898453|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.872|TWO_SIDED|95.0|0.87|1.72||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 \< median||1.72|0.87|0.872
91513401|NCT03447769|182898453|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.303|TWO_SIDED|95.0|0.62|1.33||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 ≥ median||1.33|0.62|0.303
91513402|NCT01385059|182898498|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91513403|NCT00022516|182898499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.14|TWO_SIDED|95.0|0.6|1.06|||Log Rank|||||1.06|0.6|0.14
91513404|NCT00022516|182898500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.357|TWO_SIDED|95.0|0.65|1.17|||Log Rank|||||1.17|0.65|0.3570
91513405|NCT00022516|182898501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3178|TWO_SIDED|95.0|0.62|1.17|||Log Rank|||||1.17|0.62|0.3178
91513406|NCT00022516|182898502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01|||Log Rank|||||1.01|0.6|0.06
91513407|NCT02328326|182898536|SUPERIORITY||Mean Difference (Net)|2.6||||0.048|TWO_SIDED|95.0|0.02|5.18|||Regression, Linear|Model was adjusted for baseline value of PAM, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.||5.18|0.02|0.048
91513408|NCT02328326|182898537|SUPERIORITY||Mean Difference (Net)|0.9||||0.32|TWO_SIDED|95.0|-0.87|2.67|||Regression, Linear|Model adjusted for baseline value of ukpds, insulin use, site, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline. Reference for comparison is PACT.|The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.||2.67|-0.87|0.32
91513409|NCT02328326|182898538|SUPERIORITY||Mean Difference (Net)|0.71||||0.01|TWO_SIDED|95.0|0.2|1.22|||Regression, Linear|Model adjusted for BL value of Healthy Eating, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.||1.22|0.20|0.01
91504340|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.08|0.14||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.14|-0.08|
91504341|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.358|TWO_SIDED|95.0|-0.06|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.17|-0.06|0.358
91504342|NCT00277212|182879712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.021|TWO_SIDED|95.0|0.03|0.31||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.31|0.03|0.021
91504343|NCT03336216|182879714|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|60.0|1.19|1.82||||||||1.82|1.19|
91504344|NCT03336216|182879714|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|60.0|0.77|1.3||||||||1.30|0.77|
91504345|NCT03336216|182879714|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|60.0|0.6|1.03||||||||1.03|0.60|
91504346|NCT03336216|182879715|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|60.0|1.33|2.02||||||||2.02|1.33|
91504347|NCT03336216|182879715|SUPERIORITY||Hazard Ratio (HR)|1.13||||||60.0|0.87|1.46||||||||1.46|0.87|
91504348|NCT03336216|182879715|SUPERIORITY||Hazard Ratio (HR)|0.72||||||60.0|0.55|0.94||||||||0.94|0.55|
91748669|NCT00487942|183389599|SUPERIORITY_OR_OTHER||Effect size|0.37|||||TWO_SIDED|95.0|-0.54|1.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.27|-0.54|
91504349|NCT03336216|182879718|SUPERIORITY||Strata adjusted difference|1.8||||0.6537||95.0|-5.5|9.0||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||9.0|-5.5|0.6537
91504350|NCT03336216|182879718|SUPERIORITY||Strata adjusted difference|12.5||||0.0951||95.0|3.1|21.9||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||21.9|3.1|0.0951
91504351|NCT03336216|182879718|SUPERIORITY||Strata adjusted difference|5.0||||0.5171||95.0|-8.0|18.1||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||18.1|-8.0|0.5171
91504352|NCT03336216|182879719|SUPERIORITY||Strata adjusted difference|-0.8||||0.8505|TWO_SIDED|95.0|-9.4|7.7||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||7.7|-9.4|0.8505
91748670|NCT00487942|183389600|SUPERIORITY_OR_OTHER||Effect size|-0.38|||||TWO_SIDED|95.0|-1.14|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.14|
91504353|NCT03336216|182879719|SUPERIORITY||Strata adjusted difference|1.5||||0.8144|TWO_SIDED|95.0|-9.9|12.8||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.8|-9.9|0.8144
91504354|NCT03336216|182879719|SUPERIORITY||Strata adjusted difference|0.7||||0.9087|TWO_SIDED|95.0|-10.7|12.1||Stratified CMH test stratified by ECOG and prior chemotherapy.|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.1|-10.7|0.9087
91504355|NCT03336216|182879722|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.76|1.96|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.96|0.76|
91504356|NCT03336216|182879722|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.59|1.86|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.86|0.59|
91504357|NCT03336216|182879722|SUPERIORITY||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.45|1.46|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.46|0.45|
91504358|NCT01023581|182879749|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.96|-0.37||For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.|ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.||-0.37|-0.96|<0.001
91504359|NCT01023581|182879749|SUPERIORITY_OR_OTHER||LS mean difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate||||-0.27|-0.87|<0.001
91504360|NCT01023581|182879749|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.29|-0.71|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.71|-1.29|<0.001
91504361|NCT01023581|182879749|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.73|-0.16|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.16|-0.73|<0.001
91504362|NCT02404311|182879829|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
91504363|NCT02404311|182879829|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
91531820|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.69|TWO_SIDED|95.0|-1.3|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-1.3|0.69
91748671|NCT00487942|183389600|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.89|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.89|
91748672|NCT00487942|183389600|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.84|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.84|
91748673|NCT00487942|183389601|SUPERIORITY_OR_OTHER||Effect size|-0.41|||||TWO_SIDED|95.0|-1.21|0.4||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.40|-1.21|
91748674|NCT00487942|183389601|SUPERIORITY_OR_OTHER||Effect size|-0.29|||||TWO_SIDED|95.0|-1.09|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-1.09|
91748675|NCT00487942|183389601|SUPERIORITY_OR_OTHER||Effect size|-0.69|||||TWO_SIDED|95.0|-1.51|0.14||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.14|-1.51|
91748676|NCT00487942|183389602|SUPERIORITY_OR_OTHER||Effect size|-0.24|||||TWO_SIDED|95.0|-1.06|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-1.06|
91748677|NCT00487942|183389602|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.85|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.85|
91748678|NCT00487942|183389602|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
91504364|NCT02404311|182879829|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
91504365|NCT02404311|182879830|OTHER||Geometric Mean difference (Net)|0.914|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
91504366|NCT02404311|182879830|OTHER||Geometric Mean difference (Net)|0.945|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
91504367|NCT02404311|182879830|OTHER||Geometric Mean difference (Net)|0.895|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
91504368|NCT02404311|182879831|OTHER||Proportion Difference (Net)|0.0||||0.0215|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0215
91504369|NCT02404311|182879831|OTHER||Proportion Difference (Net)|0.0||||0.0003|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0003
91504370|NCT02404311|182879831|OTHER||Proportion Difference (Net)|0.228||||0.001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0010
91504371|NCT02404311|182879832|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
91504372|NCT02404311|182879832|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
91504373|NCT02404311|182879832|OTHER||Geometric Mean difference (Net)|6.099||||0.0002|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0002
91504374|NCT02404311|182879833|OTHER||Proportion Difference (Net)|0.018||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
91504375|NCT02404311|182879833|OTHER||Proportion Difference (Net)|0.036||||0.6698|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.6698
91504376|NCT02404311|182879833|OTHER||Proportion Difference (Net)|0.125||||0.1435|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.1435
91504377|NCT02404311|182879834|OTHER||Geometric Mean difference (Net)|0.965||||0.9661|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.9661
91504378|NCT02404311|182879834|OTHER||Geometric Mean difference (Net)|1.118||||0.8593|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.8593
91504379|NCT02404311|182879834|OTHER||Geometric Mean difference (Net)|1.138||||0.4396|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.4396
91504380|NCT00159588|182879841|SUPERIORITY|||||||0.056||||||Between-group analysis|Kruskal-Wallis|||Kruskal-Wallis test||||0.056
91504381|NCT00159588|182879842|SUPERIORITY|Between-group analysis||||||0.012||||||Between-group analysis|t-test, 2 sided|Kruskal-Wallis test||Kruskal-Wallis test||||0.012
91504382|NCT03314584|182879850|SUPERIORITY||||||<|0|||||||Mixed Models Analysis|F=21.662, df = 1||||||<0.000
91504383|NCT03314584|182879851|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|F=5.624, df=1||||||0.004
91504384|NCT03314584|182879852|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|F=3.092, df=1||||||0.046
91504385|NCT03314584|182879853|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|F=4.022, df=1||||||0.018
91504386|NCT03314584|182879854|SUPERIORITY|||||||0.598|||||||Mixed Models Analysis|F=0.279, df=1||||||0.598
91504387|NCT03314584|182879855|SUPERIORITY|||||||0.296|||||||Mixed Models Analysis|F=1.101, df=1||||||0.296
91504388|NCT03314584|182879856|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|F=4.672, df = 1||||||0.033
91504389|NCT03314584|182879857|SUPERIORITY|||||||0.606|||||||Mixed Models Analysis|F=0.268, df=1||||||0.606
91504390|NCT03314584|182879858|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|F=1.142, df=1||||||0.287
91504391|NCT03314584|182879859|SUPERIORITY|||||||0.049|||||||Mixed Models Analysis|F=4.039, df=1||||||0.049
91504392|NCT03314584|182879860|SUPERIORITY|||||||0.338|||||||Mixed Models Analysis|F=1.084, df=1||||||0.338
91504393|NCT00755131|182879968|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Sample size determination was based on a t-test assuming a normal distribution with non-equal variance with the mean and standard deviation for the experimental group (postinfarction patients) of HMGB1 levels equal to 15 ± 7 and 2 ± 1 ng/dl for the control group derived from a previous study, respectively. The required sample size was calculated to be 30 subjects per group to detect on the size of one SD with α value of 0.05 (two-sided) and power (1 - β) of 0.8.||||<0.05
91504394|NCT00755131|182879969|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91504395|NCT00755131|182879970|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91504396|NCT01480076|182879979|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 3: Mixed effect model for repeated measures with visit, baseline PCS score, baseline Expanded Disability Status Scale (EDSS) score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504397|NCT01480076|182879979|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504398|NCT01480076|182879979|SUPERIORITY_OR_OTHER||least squares mean|0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0007|TWO_SIDED||||||mixed effect model|||Difference of Month 3 versus Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
91504399|NCT01480076|182879979|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within-group p-value|mixed effect model|||Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504400|NCT01480076|182879979|SUPERIORITY_OR_OTHER||least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2531|TWO_SIDED||||||mixed effect model|||Difference of Month 6 versus Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2531
91504401|NCT01480076|182879979|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531821|NCT02886728|182939625|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82||0.95|TWO_SIDED|95.0|-1.7|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.7|0.95
91531822|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|2.1|4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.4|2.1|<0.001
91504402|NCT01480076|182879979|SUPERIORITY_OR_OTHER||least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2299|TWO_SIDED||||||mixed effect model|||Difference of Month 9 versus Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2299
91504403|NCT01480076|182879980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504404|NCT01480076|182879980|SUPERIORITY_OR_OTHER|||||||0.5405|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5405
91504405|NCT01480076|182879980|SUPERIORITY_OR_OTHER||least squares mean|3.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504406|NCT01480076|182879980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504407|NCT01480076|182879980|SUPERIORITY_OR_OTHER|||||||0.7272|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7272
91504408|NCT01480076|182879980|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504409|NCT01480076|182879980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504410|NCT01480076|182879980|SUPERIORITY_OR_OTHER|||||||0.7484|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7484
91504411|NCT01480076|182879980|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504412|NCT01480076|182879980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504413|NCT01480076|182879980|SUPERIORITY_OR_OTHER|||||||0.1877|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1877
91504414|NCT01480076|182879980|SUPERIORITY_OR_OTHER||least squares mean|4.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504415|NCT01480076|182879980|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504416|NCT01480076|182879980|SUPERIORITY_OR_OTHER|||||||0.546|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5460
91504417|NCT01480076|182879980|SUPERIORITY_OR_OTHER||least squares mean|3.3|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504418|NCT01480076|182879981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504419|NCT01480076|182879981|SUPERIORITY_OR_OTHER|||||||0.9073|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9073
91504420|NCT01480076|182879981|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.89||0.0009|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
91504421|NCT01480076|182879981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504422|NCT01480076|182879981|SUPERIORITY_OR_OTHER|||||||0.5542|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5542
91504423|NCT01480076|182879981|SUPERIORITY_OR_OTHER||least squares mean|4.8|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504424|NCT01480076|182879981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504425|NCT01480076|182879981|SUPERIORITY_OR_OTHER|||||||0.581|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5810
91504426|NCT01480076|182879981|SUPERIORITY_OR_OTHER||least squares mean|2.7|STANDARD_ERROR_OF_MEAN|1.08||0.014|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0140
91504427|NCT01480076|182879981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531823|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
91531824|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.3|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|1.3|<0.001
91531825|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.0|3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.5|1.0|<0.001
91531826|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.78||0.13|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.13
91531827|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.79||0.032|TWO_SIDED|95.0|0.1|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|0.1|0.032
91504428|NCT01480076|182879981|SUPERIORITY_OR_OTHER|||||||0.4138|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4138
91531828|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.67||0.028|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.028
91748679|NCT00487942|183389605|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.8|0.71||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.71|-0.80|
91531829|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.81||0.15|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.15
91504429|NCT01480076|182879981|SUPERIORITY_OR_OTHER||least squares mean|1.3|STANDARD_ERROR_OF_MEAN|1.19||0.274|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
91504430|NCT01480076|182879981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504431|NCT01480076|182879981|SUPERIORITY_OR_OTHER|||||||0.6453|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6453
91504432|NCT01480076|182879981|SUPERIORITY_OR_OTHER||least squares mean|3.1|STANDARD_ERROR_OF_MEAN|1.18||0.009|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0090
91504433|NCT01480076|182879982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531830|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.81||0.41|TWO_SIDED|95.0|-0.9|2.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.3|-0.9|0.41
91531831|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.71||0.017|TWO_SIDED|95.0|0.3|3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.1|0.3|0.017
91531832|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.27|TWO_SIDED|95.0|-0.7|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.7|0.27
91531833|NCT02886728|182939627|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.87||0.15|TWO_SIDED|95.0|-0.5|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.5|0.15
91531834|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|6.0|12.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|6.0|<0.001
91504434|NCT01480076|182879982|SUPERIORITY_OR_OTHER|||||||0.2475|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2475
91504435|NCT01480076|182879982|SUPERIORITY_OR_OTHER||least squares mean|-8.2|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504436|NCT01480076|182879982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531835|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|95.0|1.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|1.0|0.006
91504437|NCT01480076|182879982|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
91504438|NCT01480076|182879982|SUPERIORITY_OR_OTHER||least squares mean|-10.9|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504439|NCT01480076|182879982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504440|NCT01480076|182879982|SUPERIORITY_OR_OTHER|||||||0.1262|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1262
91504441|NCT01480076|182879982|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531836|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|3.0|<0.001
91531837|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|<0.001
91531838|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.8||0.089|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.089
91504442|NCT01480076|182879982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504443|NCT01480076|182879982|SUPERIORITY_OR_OTHER|||||||0.8858|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8858
91504444|NCT01480076|182879982|SUPERIORITY_OR_OTHER||least squares mean|-8.6|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504445|NCT01480076|182879982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504446|NCT01480076|182879982|SUPERIORITY_OR_OTHER|||||||0.2111|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2111
91504447|NCT01480076|182879982|SUPERIORITY_OR_OTHER||least squares mean|-5.8|STANDARD_ERROR_OF_MEAN|2.16||0.0072|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0072
91504448|NCT01480076|182879983|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504449|NCT01480076|182879983|SUPERIORITY_OR_OTHER|||||||0.5577|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5577
91504450|NCT01480076|182879983|SUPERIORITY_OR_OTHER||least squares mean|-6.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504451|NCT01480076|182879983|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504452|NCT01480076|182879983|SUPERIORITY_OR_OTHER|||||||0.9365|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9365
91504453|NCT01480076|182879983|SUPERIORITY_OR_OTHER||least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504454|NCT01480076|182879983|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504455|NCT01480076|182879983|SUPERIORITY_OR_OTHER|||||||0.2008|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2008
91504456|NCT01480076|182879983|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|1.98||0.0102|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
91504457|NCT01480076|182879983|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504458|NCT01480076|182879983|SUPERIORITY_OR_OTHER|||||||0.7134|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7134
91504459|NCT01480076|182879983|SUPERIORITY_OR_OTHER||least squares mean|-6.0|STANDARD_ERROR_OF_MEAN|2.2||0.0066|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0066
91504460|NCT01480076|182879983|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531839|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-1.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-1.0|0.18
91504461|NCT01480076|182879983|SUPERIORITY_OR_OTHER|||||||0.8202|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8202
91531840|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|1.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|1.0|0.003
91748680|NCT00487942|183389605|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.06|0.45||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.06|
91748681|NCT00487942|183389605|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.68|0.89||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.68|
91748682|NCT00487942|183389606|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.88|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.88|
91748683|NCT00487942|183389606|SUPERIORITY_OR_OTHER||Effect size|0.05|||||TWO_SIDED|95.0|-0.72|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.72|
91748684|NCT00487942|183389606|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.80|
91748685|NCT00487942|183389607|SUPERIORITY_OR_OTHER||Effect size|-0.62|||||TWO_SIDED|95.0|-1.44|0.2||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.20|-1.44|
91748686|NCT00487942|183389607|SUPERIORITY_OR_OTHER||Effect size|-0.18|||||TWO_SIDED|95.0|-0.98|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.98|
91748687|NCT00487942|183389607|SUPERIORITY_OR_OTHER||Effect size|-0.17|||||TWO_SIDED|95.0|-0.97|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.97|
91748688|NCT00487942|183389608|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
91748689|NCT00487942|183389608|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
91748690|NCT00487942|183389608|SUPERIORITY_OR_OTHER||Effect size|0.08|||||TWO_SIDED|95.0|-0.72|0.89||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.72|
91504462|NCT01480076|182879983|SUPERIORITY_OR_OTHER||least squares mean|-6.4|STANDARD_ERROR_OF_MEAN|2.28||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
91504463|NCT01480076|182879984|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504464|NCT01480076|182879984|SUPERIORITY_OR_OTHER|||||||0.1324|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1324
91504465|NCT01480076|182879984|SUPERIORITY_OR_OTHER||least squares mean|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504466|NCT01480076|182879984|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504467|NCT01480076|182879984|SUPERIORITY_OR_OTHER|||||||0.4759|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4759
91504468|NCT01480076|182879984|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.59||0.0016|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
91504469|NCT01480076|182879984|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error||||<0.0001
91504470|NCT01480076|182879984|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2489
91504471|NCT01480076|182879984|SUPERIORITY_OR_OTHER||least squares mean|-2.2|STANDARD_ERROR_OF_MEAN|0.71||0.0017|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0017
91531841|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.8||0.049|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|0.0|0.049
91504472|NCT01480076|182879984|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504473|NCT01480076|182879984|SUPERIORITY_OR_OTHER|||||||0.0126|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0126
91504474|NCT01480076|182879984|SUPERIORITY_OR_OTHER||least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504475|NCT01480076|182879984|SUPERIORITY_OR_OTHER|||||||0.0033|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
91504476|NCT01480076|182879984|SUPERIORITY_OR_OTHER|||||||0.1758|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1758
91748691|NCT00487942|183389609|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.65|0.87||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.65|
91748692|NCT00487942|183389609|SUPERIORITY_OR_OTHER||Effect size|0.13|||||TWO_SIDED|95.0|-0.63|0.88||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.63|
91748693|NCT00487942|183389609|SUPERIORITY_OR_OTHER||Effect size|1.69|||||TWO_SIDED|95.0|0.78|2.6||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.60|0.78|
91748694|NCT00487942|183389610|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.06|0.46||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.46|-1.06|
91748695|NCT00487942|183389610|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.87|0.67||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.67|-0.87|
91748696|NCT00487942|183389610|SUPERIORITY_OR_OTHER||Effect size|0.89|||||TWO_SIDED|95.0|0.05|1.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.74|0.05|
91748697|NCT00487942|183389611|SUPERIORITY_OR_OTHER||Effect size|-0.25|||||TWO_SIDED|95.0|-1.05|0.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.55|-1.05|
91748698|NCT00487942|183389611|SUPERIORITY_OR_OTHER||Effect size|0.29|||||TWO_SIDED|95.0|-0.52|1.09||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.09|-0.52|
91504477|NCT01480076|182879984|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.0246|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0246
91504478|NCT01480076|182879985|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504479|NCT01480076|182879985|SUPERIORITY_OR_OTHER|||||||0.0111|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0111
91504480|NCT01480076|182879985|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91748699|NCT00487942|183389611|SUPERIORITY_OR_OTHER||Effect size|0.75|||||TWO_SIDED|95.0|-0.08|1.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.58|-0.08|
91748700|NCT00487942|183389612|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
91748701|NCT00487942|183389612|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.27|1.36||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.36|-0.27|
91748702|NCT00487942|183389612|SUPERIORITY_OR_OTHER||Effect size|1.62|||||TWO_SIDED|95.0|0.7|2.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.55|0.70|
91748703|NCT00487942|183389613|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
91748704|NCT00487942|183389613|SUPERIORITY_OR_OTHER||Effect size|-0.11|||||TWO_SIDED|95.0|-0.87|0.64||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.64|-0.87|
91748705|NCT00487942|183389613|SUPERIORITY_OR_OTHER||Effect size|0.73|||||TWO_SIDED|95.0|-0.08|1.54||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.54|-0.08|
91748706|NCT00487942|183389614|SUPERIORITY_OR_OTHER||Effect size|-0.5|||||TWO_SIDED|95.0|-1.27|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.27|
91748707|NCT00487942|183389614|SUPERIORITY_OR_OTHER||Effect size|-0.28|||||TWO_SIDED|95.0|-1.05|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.05|
91748708|NCT00487942|183389614|SUPERIORITY_OR_OTHER||Effect size|0.3|||||TWO_SIDED|95.0|-0.51|1.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.11|-0.51|
91504481|NCT01480076|182879985|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504482|NCT01480076|182879985|SUPERIORITY_OR_OTHER|||||||0.097|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0970
91504483|NCT01480076|182879985|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504484|NCT01480076|182879985|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504485|NCT01480076|182879985|SUPERIORITY_OR_OTHER|||||||0.0789|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0789
91504486|NCT01480076|182879985|SUPERIORITY_OR_OTHER||least squares mean|9.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504487|NCT01480076|182879985|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504488|NCT01480076|182879985|SUPERIORITY_OR_OTHER|||||||0.0284|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0284
91504489|NCT01480076|182879985|SUPERIORITY_OR_OTHER||least squares mean|11.2|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504490|NCT01480076|182879985|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504491|NCT01480076|182879985|SUPERIORITY_OR_OTHER|||||||0.0108|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0108
91504492|NCT01480076|182879985|SUPERIORITY_OR_OTHER||least squares mean|12.3|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504493|NCT01480076|182879986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504494|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.8392|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8392
91504495|NCT01480076|182879986|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0162|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0162
91504496|NCT01480076|182879986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504497|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.6956|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6956
91504498|NCT01480076|182879986|SUPERIORITY_OR_OTHER||least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
91504499|NCT01480076|182879986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504500|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.7949|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7949
91504501|NCT01480076|182879986|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0679|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0679
91504502|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
91504503|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.8053|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8053
91504504|NCT01480076|182879986|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2638|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2638
91504505|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
91504506|NCT01480076|182879986|SUPERIORITY_OR_OTHER|||||||0.8502|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8502
91531842|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.8||0.84|TWO_SIDED|95.0|-4.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-4.0|0.84
91504507|NCT01480076|182879986|SUPERIORITY_OR_OTHER||least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0917|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0917
91504508|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.1795|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1795
91504509|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.0715|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0715
91504510|NCT01480076|182879987|SUPERIORITY_OR_OTHER||least squares mean|5.8|STANDARD_ERROR_OF_MEAN|4.6||0.2065|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2065
91504511|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.1649|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1649
91504512|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.4894|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4894
91504513|NCT01480076|182879987|SUPERIORITY_OR_OTHER||least squares mean|1.0|STANDARD_ERROR_OF_MEAN|5.89||0.8611|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8611
91504514|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.0073|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0073
91504515|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.1343|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1343
91504516|NCT01480076|182879987|SUPERIORITY_OR_OTHER||least squares mean|2.3|STANDARD_ERROR_OF_MEAN|5.09||0.6468|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6468
91504517|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.6441|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6441
91504518|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.2176|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2176
91504519|NCT01480076|182879987|SUPERIORITY_OR_OTHER||least squares mean|8.5|STANDARD_ERROR_OF_MEAN|7.91||0.2814|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2814
91504520|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.7533|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7533
91504521|NCT01480076|182879987|SUPERIORITY_OR_OTHER|||||||0.0653|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0653
91504522|NCT01480076|182879987|SUPERIORITY_OR_OTHER||least squares mean|11.4|STANDARD_ERROR_OF_MEAN|6.65||0.0876|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0876
91504523|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.0281|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0281
91748709|NCT00487942|183389615|SUPERIORITY_OR_OTHER||Effect size|-0.12|||||TWO_SIDED|95.0|-0.92|0.68||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.92|
91531843|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|2.0|<0.001
91504524|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
91748710|NCT00487942|183389615|SUPERIORITY_OR_OTHER||Effect size|0.07|||||TWO_SIDED|95.0|-0.73|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.73|
91748711|NCT00487942|183389615|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.77|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.77|
91531844|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.0||0.078|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.078
91504525|NCT01480076|182879988|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|4.47||0.34|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3400
91504526|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0012
91504527|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.749|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7490
91531845|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.39|TWO_SIDED|95.0|-2.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-2.0|0.39
91504528|NCT01480076|182879988|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|5.53||0.3592|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3592
91504529|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.0015|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0015
91504530|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.2967|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2967
91504531|NCT01480076|182879988|SUPERIORITY_OR_OTHER||least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|5.34||0.8735|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8735
91504532|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.1696|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1696
91531846|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.7||0.004|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.004
91531847|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.45|TWO_SIDED|95.0|-3.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-3.0|0.45
91504533|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.0089|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0089
91531848|NCT02886728|182939630|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-4.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-4.0|0.85
91504534|NCT01480076|182879988|SUPERIORITY_OR_OTHER||least squares mean|14.9|STANDARD_ERROR_OF_MEAN|6.83||0.0297|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0297
91504535|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.8806|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8806
91504536|NCT01480076|182879988|SUPERIORITY_OR_OTHER|||||||0.217|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2170
91535617|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0918|TWO_SIDED|95.0|-0.09|1.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.15|-0.09|0.0918
91504537|NCT01480076|182879988|SUPERIORITY_OR_OTHER||least squares mean|8.1|STANDARD_ERROR_OF_MEAN|6.86||0.2392|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2392
91504538|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
91504539|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.1259|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
91504540|NCT01480076|182879989|SUPERIORITY_OR_OTHER||least squares mean|3.6|STANDARD_ERROR_OF_MEAN|5.68||0.5312|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5312
91504541|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0022
91504542|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.4968|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4968
91748712|NCT00487942|183389616|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.8||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.80|-0.80|
91748713|NCT00487942|183389616|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.62|0.98||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.62|
91748714|NCT00487942|183389616|SUPERIORITY_OR_OTHER||Effect size|0.66|||||TWO_SIDED|95.0|-0.16|1.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.49|-0.16|
91748715|NCT00487942|183389617|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
91748716|NCT00487942|183389617|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.73|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.73|
91748717|NCT00487942|183389617|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-1.01|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-1.01|
91748718|NCT00487942|183389618|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
91748719|NCT00487942|183389618|SUPERIORITY_OR_OTHER||Effect size|-0.02|||||TWO_SIDED|95.0|-0.79|0.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.79|
91748720|NCT00487942|183389618|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.11|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.11|
91748721|NCT00487942|183389619|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.95|0.65||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.65|-0.95|
91531849|NCT01676220|182939646|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|-0.09|0.174||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.174|-0.090|
91748722|NCT00487942|183389619|SUPERIORITY_OR_OTHER||Effect size|-0.07|||||TWO_SIDED|95.0|-0.87|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.87|
91748723|NCT00487942|183389619|SUPERIORITY_OR_OTHER||Effect size|-0.43|||||TWO_SIDED|95.0|-1.24|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.24|
91748724|NCT00487942|183389620|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.75|0.86||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.75|
91504543|NCT01480076|182879989|SUPERIORITY_OR_OTHER||least squares mean|-3.2|STANDARD_ERROR_OF_MEAN|6.64||0.6283|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6283
91504544|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
91504545|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.6631|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6631
91748725|NCT00487942|183389620|SUPERIORITY_OR_OTHER||Effect size|-0.19|||||TWO_SIDED|95.0|-0.99|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.99|
91504546|NCT01480076|182879989|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|6.77||0.477|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4770
91504547|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.4027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4027
91504548|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.1077|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1077
91504549|NCT01480076|182879989|SUPERIORITY_OR_OTHER||least squares mean|13.5|STANDARD_ERROR_OF_MEAN|9.98||0.1781|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1781
91748726|NCT00487942|183389620|SUPERIORITY_OR_OTHER||Effect size|-0.47|||||TWO_SIDED|95.0|-1.28|0.34||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.34|-1.28|
91504550|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
91504551|NCT01480076|182879989|SUPERIORITY_OR_OTHER|||||||0.0994|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0994
91748727|NCT05151445|183389634|OTHER||95% CI|-3.56||||0.002|TWO_SIDED|95.0|-5.65|-1.46|||McNemar|||Week 4 vs. Baseline||-1.46|-5.65|0.002
91504552|NCT01480076|182879989|SUPERIORITY_OR_OTHER||least squares mean|8.8|STANDARD_ERROR_OF_MEAN|7.13||0.2194|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2194
91504553|NCT01480076|182879990|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504554|NCT01480076|182879990|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
91531850|NCT01676220|182939647|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.4536|TWO_SIDED|95.0|0.66|1.2|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (\<8.0, \>=8.0%), randomization strata of geographical region (Non-Japan; Japan).||1.20|0.66|0.4536
91748728|NCT05151445|183389634|OTHER||95% CI|-3.11||||0.004|TWO_SIDED|95.0|-5.07|-1.15|||McNemar|||Week 8 vs. Baseline||-1.15|-5.07|0.004
91748729|NCT05151445|183389634|OTHER||95% CI|-2.53||||0.038|TWO_SIDED|95.0|-4.9|0.16|||McNemar|||Week 12 vs. Baseline||0.16|-4.90|0.038
91748730|NCT05151445|183389635|OTHER||95% CI|9.61||||0.062|TWO_SIDED|95.0|-0.55|19.77|||McNemar|||Week 4 vs. Baseline||19.77|-0.55|0.062
91748731|NCT05151445|183389635|OTHER||95% CI|9.78||||0.098|TWO_SIDED|95.0|-2.01|21.56|||McNemar|||Week 8 vs. Baseline||21.56|-2.01|0.098
91748732|NCT05151445|183389635|OTHER||95% CI|17.06||||0.003|TWO_SIDED|95.0|6.51|27.6|||McNemar|||Week 12 vs. Baseline||27.60|6.51|0.003
91748733|NCT05151445|183389636|OTHER|||||||0.37|||||||McNemar|||Week 4 vs. Baseline||||0.37
91748734|NCT05151445|183389636|OTHER|||||||0.724|||||||McNemar|||Week 8 vs. Baseline||||0.724
91748735|NCT05151445|183389636|OTHER|||||||0.289|||||||McNemar|||Week 12 vs. Baseline||||0.289
91748736|NCT05151445|183389637|OTHER|||||||1|||||||McNemar|||Week 4 vs. Baseline||||1.000
91748737|NCT05151445|183389637|OTHER|||||||1|||||||McNemar|||Week 8 vs. Baseline||||1.000
91748738|NCT05151445|183389637|OTHER|||||||1|||||||McNemar|||Weel 12 vs. Baseline||||1.000
91748739|NCT05151445|183389638|OTHER||95% CI|-1.1||||0.696|TWO_SIDED|95.0|-6.96|4.76|||McNemar|||Week 4 vs. Baseline||4.76|-6.96|0.696
91748740|NCT05151445|183389638|OTHER||95% CI|-1.08||||0.734|TWO_SIDED|95.0|-7.72|5.56|||McNemar|||Week 8 vs. Baseline||5.56|-7.72|0.734
91748741|NCT05151445|183389638|OTHER||95% CI|-4.15||||0.249|TWO_SIDED|95.0|-11.53|3.23|||McNemar|||Week 12 vs. Baseline||3.23|-11.53|0.249
91748742|NCT05151445|183389639|OTHER||95% CI|-0.04||||0.989|TWO_SIDED|95.0|-5.25|5.18|||McNemar|||Week 4 vs. Baseline||5.18|-5.25|0.989
91748743|NCT05151445|183389639|OTHER||95% CI|3.43||||0.263|TWO_SIDED|95.0|-2.83|9.69|||McNemar|||Week 8 vs. Baseline||9.69|-2.83|0.263
91748744|NCT05151445|183389639|OTHER||Slope|0.44||||0.882|TWO_SIDED|95.0|-5.8|6.68|||McNemar|||Week 12 vs. Baseline||6.68|-5.80|0.882
91748745|NCT05151445|183389640|OTHER||95% CI|-0.62||||0.425|TWO_SIDED|95.0|-2.23|0.98|||McNemar|||Week 4 vs. Baseline||0.98|-2.23|0.425
91748746|NCT05151445|183389640|OTHER||95% CI|-4.98||||0.205|TWO_SIDED|95.0|-9.08|-0.88|||McNemar|||Week 8 vs. Baseline||-0.88|-9.08|0.205
91748747|NCT05151445|183389640|OTHER||95% CI|-4.98||||0.02|TWO_SIDED|95.0|-9.08|-0.8|||McNemar|||Week 12 vs. Baseline||-0.8|-9.08|0.020
91748748|NCT05151445|183389641|OTHER||95% CI|0.429||||0.429|TWO_SIDED|95.0|-4.9|11.01|||McNemar|||Week 4 vs. Baseline||11.01|-4.90|0.429
91748749|NCT05151445|183389641|OTHER||95% CI|-4.39||||0.255|TWO_SIDED|95.0|-12.24|3.46|||McNemar|||Week 8 vs. Baseline||3.46|-12.24|0.255
91748750|NCT05151445|183389641|OTHER||95% CI|-7.0||||0.102|TWO_SIDED|95.0|-15.55|1.55|||McNemar|||Week 12 vs. Baseline||1.55|-15.55|0.102
91748751|NCT05151445|183389642|OTHER||95% CI|-1.94||||0.568|TWO_SIDED|95.0|-8.99|5.1|||McNemar|||Week 4 vs. Baseline||5.10|-8.99|0.568
91748752|NCT05151445|183389642|OTHER||95% CI|-4.11||||0.198|TWO_SIDED|95.0|-10.59|2.37|||McNemar|||Week 8 vs. Baseline||2.37|-10.59|0.198
91748753|NCT05151445|183389642|OTHER||95% CI|-3.76||||0.225|TWO_SIDED|95.0|-10.08|2.55|||McNemar|||Week 12 vs. Baseline||2.55|-10.08|.225
91748754|NCT02825420|183389667|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
91748755|NCT02825420|183389668|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
91748756|NCT02825420|183389669|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
91748757|NCT02825420|183389671|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
91748758|NCT02825420|183389673|SUPERIORITY|||||||0.048|||||||Log Rank|||||||0.048
91748759|NCT02825420|183389674|SUPERIORITY|||||||0.51|||||||Log Rank|||||||0.51
91748760|NCT00642174|183389719|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Net)|61.6|||<|0.0001||95.0|53.83|69.31||P-value is for 4 Hours After Loading Dose.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (i.e. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there is no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 4 hours after administration of loading dose. Assuming 90% power, 2-sided alpha of 0.05, and a 17.5% difference in IPA between treatment groups with a standard deviation of 20, a total of 15 completed subjects per sequence group (i.e., 15 subject who receive prasugrel first, then clopidogrel; and 15 subjects who receive clopidogrel first, then prasugrel) was determined.||69.31|53.83|<0.0001
91504555|NCT01480076|182879990|SUPERIORITY_OR_OTHER||least squares mean|-7.3|STANDARD_ERROR_OF_MEAN|2.2||0.001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
91504556|NCT01480076|182879990|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91748761|NCT00642174|183389720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.5|||<|0.0001||95.0|27.43|45.52||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 1 hour after administration of the loading dose.||45.52|27.43|<0.0001
91748762|NCT00642174|183389720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.9|||<|0.0001||95.0|49.56|66.19||P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours after administration of the loading dose.||66.19|49.56|<0.0001
91748763|NCT00642174|183389720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.7|||<|0.0001||95.0|10.27|25.04||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours post-Last Maintenance Dose (LMD).||25.04|10.27|<0.0001
91748764|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.5466||95.0|-3.66|1.97||P-value for Baseline (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||1.97|-3.66|0.5466
91748765|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.0|||<|0.0001||95.0|-28.45|-17.55||P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.55|-28.45|<0.0001
91748766|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.6|||<|0.0001||95.0|-31.18|-22.02||P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-22.02|-31.18|<0.0001
91748767|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|||<|0.0001||95.0|-27.42|-19.17||P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-19.17|-27.42|<0.0001
91748768|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0001||95.0|-12.78|-4.58||P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-4.58|-12.78|0.0001
91748769|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.8779||95.0|-2.8|3.26||P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||3.26|-2.80|0.8779
91748770|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.2|||<|0.0001||95.0|-32.43|-17.87||P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.87|-32.43|<0.0001
91748771|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.1|||<|0.0001||95.0|-40.32|-29.78||P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-29.78|-40.32|<0.0001
91504557|NCT01480076|182879990|SUPERIORITY_OR_OTHER|||||||0.2777|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2777
91504558|NCT01480076|182879990|SUPERIORITY_OR_OTHER||least squares mean|-10.4|STANDARD_ERROR_OF_MEAN|2.76||0.0002|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
91504559|NCT01480076|182879990|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504560|NCT01480076|182879990|SUPERIORITY_OR_OTHER|||||||0.1078|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1078
91748772|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|||<|0.0001||95.0|-36.32|-25.66||P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-25.66|-36.32|<0.0001
91504561|NCT01480076|182879990|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|2.87||0.0082|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0082
91504562|NCT01480076|182879990|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504563|NCT01480076|182879990|SUPERIORITY_OR_OTHER|||||||0.1838|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1838
91504564|NCT01480076|182879990|SUPERIORITY_OR_OTHER||least squares mean|-6.3|STANDARD_ERROR_OF_MEAN|3.02||0.0364|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0364
91504565|NCT01480076|182879990|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504566|NCT01480076|182879990|SUPERIORITY_OR_OTHER|||||||0.1714|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1714
91504567|NCT01480076|182879990|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|3.14||0.1259|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
91504568|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504569|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504570|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504571|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0004
91504572|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91748773|NCT00642174|183389721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.4|||<|0.0001||95.0|-17.19|-7.58||P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-7.58|-17.19|<0.0001
91748774|NCT00642174|183389722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.3692||95.0|-3.6|9.44||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||9.44|-3.60|0.3692
91748775|NCT00642174|183389722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.2|||<|0.0001||95.0|-47.43|-24.98||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-24.98|-47.43|<0.0001
91748776|NCT00642174|183389722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.0|||<|0.0001||95.0|-61.89|-44.02||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-44.02|-61.89|<0.0001
91748777|NCT00642174|183389722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.8|||<|0.0001||95.0|-50.03|-35.55||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-35.55|-50.03|<0.0001
91748778|NCT00642174|183389722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9||||0.0012||95.0|-23.42|-6.37||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-6.37|-23.42|0.0012
91748779|NCT00642174|183389723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.5238||95.0|-5.35|2.78||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||2.78|-5.35|0.5238
91748780|NCT00642174|183389723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.2|||<|0.0001||95.0|-21.15|-11.33||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-11.33|-21.15|<0.0001
91748781|NCT00642174|183389723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9|||<|0.0001||95.0|-29.67|-18.11||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-18.11|-29.67|<0.0001
91748782|NCT00642174|183389723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001||95.0|-24.97|-14.9||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-14.90|-24.97|<0.0001
91504573|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91748783|NCT00642174|183389723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.3725||95.0|-8.46|3.26||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||3.26|-8.46|0.3725
91748784|NCT00896363|183389724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85|||||TWO_SIDED|90.0|-1.62|3.32|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 14||3.32|-1.62|
91748785|NCT00896363|183389724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||||TWO_SIDED|90.0|-2.12|2.78|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 14||2.78|-2.12|
91748786|NCT00896363|183389724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|||||TWO_SIDED|90.0|-2.01|5.14|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 42||5.14|-2.01|
91748787|NCT00896363|183389724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|||||TWO_SIDED|90.0|-1.81|5.13|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 42||5.13|-1.81|
91748788|NCT00896363|183389725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|||||TWO_SIDED|90.0|-0.93|1.56|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 14||1.56|-0.93|
91748789|NCT00896363|183389725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|||||TWO_SIDED|90.0|-0.73|1.75|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.75|-0.73|
91748790|NCT00896363|183389725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|||||TWO_SIDED|90.0|-1.1|2.42|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.42|-1.10|
91748791|NCT00896363|183389725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||||TWO_SIDED|90.0|-0.93|2.48|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.48|-0.93|
91748792|NCT00896363|183389726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|||||TWO_SIDED|90.0|-0.94|2.37|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 14||2.37|-0.94|
91748793|NCT00896363|183389726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44|||||TWO_SIDED|90.0|-2.1|1.21|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.21|-2.10|
91748794|NCT00896363|183389726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|||||TWO_SIDED|90.0|-1.22|2.9|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.90|-1.22|
91748795|NCT00896363|183389726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|||||TWO_SIDED|90.0|-1.22|2.85|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.85|-1.22|
91748796|NCT01730339|183389741|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.0219|TWO_SIDED|90.0|0.19|1.16|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.16|0.19|0.0219
91748797|NCT01730339|183389741|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.4038|TWO_SIDED|90.0|-0.24|0.72|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.72|-0.24|0.4038
91748798|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.43|0.2||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.20|-0.43|
91748799|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.43|0.11||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.11|-0.43|
91748800|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.15|0.52||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.15|
91504574|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504575|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.0069|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0069
91504576|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504577|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504578|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
91504579|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0006
91504580|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504581|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504582|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504583|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
91504584|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91748801|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.22|0.36||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.36|-0.22|
91748802|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.07|0.77||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.77|0.07|
91748803|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.05|0.65||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.65|0.05|
91748804|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.03|0.68||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|-0.03|
91748805|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.52||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.09|
91748806|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.18|0.42||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.18|
91748807|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.35|0.22||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.22|-0.35|
91748808|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.47|0.24||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.47|
91748809|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.6|0.06||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.06|-0.60|
91748810|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.35|0.41||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.41|-0.35|
91504585|NCT01480076|182879991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504586|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.0047|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0047
91504587|NCT01480076|182879991|SUPERIORITY_OR_OTHER|||||||0.0118|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0118
91504588|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504589|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531851|NCT01676220|182939648|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|95.0|-0.275|0.605||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.||0.605|-0.275|
91504590|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91748811|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.33|0.37||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.37|-0.33|
91748812|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.24|0.53||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.53|-0.24|
91748813|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.39|0.32||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.39|
91748814|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.22|0.58||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.58|-0.22|
91748815|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.42|0.35||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.42|
91748816|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.05|0.84||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.84|-0.05|
91748817|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.62|0.23||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.62|
91748818|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.4|1.49||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.49|0.40|
91748819|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.3|0.72||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|-0.30|
91748820|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.13|1.24||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.24|0.13|
91748821|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.38|0.67||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.38|
91748822|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.01|0.78||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.78|-0.01|
91748823|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.28||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.28|-0.50|
91748824|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.23|0.67||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.23|
91504591|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.1398|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1398
91504592|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504593|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531852|NCT01152554|182939760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.24||0.697|TWO_SIDED|95.0|0.54|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.54|0.697
91531853|NCT01152554|182939761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.27||0.582|TWO_SIDED|95.0|0.45|1.57|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.57|0.45|0.582
91531854|NCT03486899|182939774|SUPERIORITY||Odds Ratio (OR)|2.65||||0.055|TWO_SIDED|95.0|0.88|8.52|||Cochran-Mantel-Haenszel|||||8.52|0.88|0.055
91531855|NCT03486899|182939774|SUPERIORITY||Odds Ratio (OR)|1.89||||0.245|TWO_SIDED|95.0|0.61|6.27|||Cochran-Mantel-Haenszel|||||6.27|0.61|0.245
91748825|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.63|0.24||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.63|
91748826|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.74|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.21|1.26||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.26|0.21|
91504594|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504595|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.0935|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0935
91504596|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504597|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504598|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531856|NCT03486899|182939774|SUPERIORITY||Odds Ratio (OR)|2.17||||0.129|TWO_SIDED|95.0|0.71|7.1|||Cochran-Mantel-Haenszel|||||7.10|0.71|0.129
91531857|NCT03486899|182939775|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
91531858|NCT03486899|182939775|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
91531859|NCT03486899|182939775|SUPERIORITY||Odds Ratio (OR)|2.88||||0.079|TWO_SIDED|95.0|0.75|13.48|||Cochran-Mantel-Haenszel|||||13.48|0.75|0.079
91531860|NCT03486899|182939776|SUPERIORITY||Odds Ratio (OR)|2.07||||0.18|TWO_SIDED|95.0|0.63|7.47|||Cochran-Mantel-Haenszel|||||7.47|0.63|0.180
91531861|NCT03486899|182939776|SUPERIORITY||Odds Ratio (OR)|1.37||||0.612|TWO_SIDED|95.0|0.38|5.2|||Cochran-Mantel-Haenszel|||||5.20|0.38|0.612
91531862|NCT03486899|182939776|SUPERIORITY||Odds Ratio (OR)|2.59||||0.079|TWO_SIDED|95.0|0.81|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.81|0.079
91531863|NCT03486899|182939777|SUPERIORITY||Odds Ratio (OR)|0.39||||0.038|TWO_SIDED|95.0|0.15|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.15|0.038
91531864|NCT03486899|182939777|SUPERIORITY||Odds Ratio (OR)|0.6||||0.256|TWO_SIDED|95.0|0.22|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.22|0.256
91531865|NCT03486899|182939777|SUPERIORITY||Odds Ratio (OR)|0.65||||0.296|TWO_SIDED|95.0|0.25|1.73|||Cochran-Mantel-Haenszel|||||1.73|0.25|0.296
91531866|NCT03486899|182939778|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
91748827|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.41|0.59||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.59|-0.41|
91748828|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.02||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.02|0.02|
91504599|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.076|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0760
91504600|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91748829|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.33|0.63||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.33|
91748830|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.09|0.67||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.09|
91748831|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.39|0.34||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.34|-0.39|
91748832|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.12|0.74||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.74|-0.12|
91748833|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.76|0.05||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.05|-0.76|
91748834|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.25|1.2||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.25|
91748835|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.46|0.42||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.46|
91748836|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.01|1.05||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.05|0.01|
91748837|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.0|0.98||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.98|0.00|
91531867|NCT03486899|182939778|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
91748838|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.29|0.62||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.62|-0.29|
91748839|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.28|0.43||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.43|-0.28|
91748840|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.0||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.00|0.02|
91748841|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.53|0.23||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.53|
91748842|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.08|1.2||||||Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.08|
91748843|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.44|0.42||||||Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.44|
91748844|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|0.09|1.28||||||Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.28|0.09|
91748845|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.23|0.69||||||Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.69|-0.23|
91748846|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2778|TWO_SIDED|90.0|-0.12|0.6|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.60|-0.12|0.2778
91748847|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.22||0.6888|TWO_SIDED|90.0|-0.28|0.45|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.45|-0.28|0.6888
91504601|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.0019|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0019
91504602|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.0037|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0037
91504603|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2489
91504604|NCT01480076|182879992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504605|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
91531868|NCT03486899|182939778|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
91531869|NCT03486899|182939779|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
91531870|NCT03486899|182939779|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
91531871|NCT03486899|182939779|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
91504606|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.0052|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0052
91504607|NCT01480076|182879992|SUPERIORITY_OR_OTHER|||||||0.7714|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7714
91504608|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504609|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504610|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504611|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531872|NCT03486899|182939780|SUPERIORITY||Odds Ratio (OR)|2.55||||0.101|TWO_SIDED|95.0|0.73|10.12|||Cochran-Mantel-Haenszel|||||10.12|0.73|0.101
91531873|NCT03486899|182939780|SUPERIORITY||Odds Ratio (OR)|1.43||||0.587|TWO_SIDED|95.0|0.36|6.17|||Cochran-Mantel-Haenszel|||||6.17|0.36|0.587
91531874|NCT03486899|182939780|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
91531875|NCT03486899|182939781|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
91531876|NCT03486899|182939781|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
91531877|NCT03486899|182939781|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
91531878|NCT03486899|182939782|SUPERIORITY||Odds Ratio (OR)|2.85||||0.06|TWO_SIDED|95.0|0.83|11.21|||Cochran-Mantel-Haenszel|||||11.21|0.83|0.060
91531879|NCT03486899|182939782|SUPERIORITY||Odds Ratio (OR)|1.93||||0.276|TWO_SIDED|95.0|0.53|7.92|||Cochran-Mantel-Haenszel|||||7.92|0.53|0.276
91531880|NCT03486899|182939782|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
91531881|NCT03486899|182939783|SUPERIORITY||Odds Ratio (OR)|1.72||||0.242|TWO_SIDED|95.0|0.62|4.87|||Cochran-Mantel-Haenszel|||||4.87|0.62|0.242
91531882|NCT03486899|182939783|SUPERIORITY||Odds Ratio (OR)|1.1||||0.803|TWO_SIDED|95.0|0.37|3.26|||Cochran-Mantel-Haenszel|||||3.26|0.37|0.803
91531883|NCT03486899|182939783|SUPERIORITY||Odds Ratio (OR)|1.56||||0.35|TWO_SIDED|95.0|0.56|4.46|||Cochran-Mantel-Haenszel|||||4.46|0.56|0.350
91531884|NCT01439711|182939784|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91531885|NCT01439711|182939785|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91504612|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504613|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504614|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504615|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504616|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531886|NCT02397460|182939798|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects on Emax following capsaicin challenge were modeled for dose dependence and were estimated on the basis of disease status for participants who were healthy or had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
91748848|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3515|TWO_SIDED|90.0|-0.18|0.65|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.65|-0.18|0.3515
91504617|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504618|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504619|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504620|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504621|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504622|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504623|NCT01480076|182879993|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0009
91504624|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504625|NCT01480076|182879993|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531887|NCT02397460|182939799|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects following capsaicin challenge were modeled for dose. dependence and were estimated on the basis of disease status for participants who had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
91504626|NCT01480076|182879993|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
91504627|NCT01480076|182879993|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
91531888|NCT01767129|182939826|SUPERIORITY||Mean Difference (Final Values)|-83.4||||0.1907|TWO_SIDED|95.0|-215.02|48.23|||ANOVA|The standard analysis of variance (ANOVA) model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The least squares (LS) mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||48.23|-215.02|0.1907
91531889|NCT01767129|182939827|SUPERIORITY||Median Difference (Final Values)|-18.9||||0.388|TWO_SIDED|95.0|-65.28|27.42|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||27.42|-65.28|0.3880
91531890|NCT01767129|182939828|SUPERIORITY||Mean Difference (Final Values)|171.9||||0.7574|TWO_SIDED|95.0|-1022.79|1366.64|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||1366.64|-1022.79|0.7574
91531891|NCT01767129|182939829|SUPERIORITY||Mean Difference (Final Values)|48.8||||0.4203|TWO_SIDED|95.0|-80.63|178.3|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||178.30|-80.63|0.4203
91531892|NCT01767129|182939830|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.1067|TWO_SIDED|95.0|-2.41|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part I||0.27|-2.41|0.1067
91531893|NCT01767129|182939830|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.865|TWO_SIDED|95.0|-2.64|3.09|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part II||3.09|-2.64|0.8650
91531894|NCT01767129|182939830|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0745|TWO_SIDED|95.0|-4.94|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part IV||0.27|-4.94|0.0745
91504628|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504629|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504630|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91531895|NCT01767129|182939831|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.0625|TWO_SIDED|95.0|-8.1|0.24|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 1||0.24|-8.10|0.0625
91531896|NCT01767129|182939831|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.2474|TWO_SIDED|95.0|-3.74|1.07|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 2||1.07|-3.74|0.2474
91531897|NCT01767129|182939832|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9764|TWO_SIDED|95.0|-3.1|3.01|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||3.01|-3.10|0.9764
91531898|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.6359|TWO_SIDED|95.0|-9.94|6.36|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Mobility||6.36|-9.94|0.6359
91531899|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0167|TWO_SIDED|95.0|-15.2|-1.87|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Activities of Daily Living||-1.87|-15.20|0.0167
91504631|NCT01480076|182879994|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
91504632|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504633|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504634|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504635|NCT01480076|182879994|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
91504636|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504637|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504638|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504639|NCT01480076|182879994|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0097
91504640|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504641|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504642|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504643|NCT01480076|182879994|SUPERIORITY_OR_OTHER|||||||0.0103|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0103
91504644|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504645|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504646|NCT01480076|182879994|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504647|NCT01480076|182879994|SUPERIORITY_OR_OTHER|||||||0.1227|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1227
91504648|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504649|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504650|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.1754|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1754
91504651|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0192|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0192
91504652|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504653|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504654|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
91748849|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3788|TWO_SIDED|90.0|-0.64|0.19|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.19|-0.64|0.3788
91748850|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.28||0.0044|TWO_SIDED|90.0|0.35|1.29|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.29|0.35|0.0044
91504655|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0157|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0157
91504656|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504657|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
91504658|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.1012|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1012
91748851|NCT01730339|183389742|SUPERIORITY_OR_OTHER||Least Square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6848|TWO_SIDED|90.0|-0.35|0.58|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.58|-0.35|0.6848
91504659|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0749|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0749
91504660|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504661|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0455|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0455
91504662|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.4699|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4699
91504663|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.0235|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0235
91504664|NCT01480076|182879995|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504665|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.1978|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1978
91504666|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.1977|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1977
91504667|NCT01480076|182879995|SUPERIORITY_OR_OTHER|||||||0.225|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2250
91504668|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504669|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504670|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504671|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.0649|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0649
91504672|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504673|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504674|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504675|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
91504676|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504677|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504678|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
91504679|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.185|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1850
91504680|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504681|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504682|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504683|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.0887|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
91504684|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504685|NCT01480076|182879996|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504686|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0011
91504687|NCT01480076|182879996|SUPERIORITY_OR_OTHER|||||||0.1853|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1853
91504688|NCT01480076|182879997|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504689|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0005|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0005
91504690|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
91504691|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
91531900|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.0959|TWO_SIDED|95.0|-16.54|1.56|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Emotional Well Being||1.56|-16.54|0.0959
91531901|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.5108|TWO_SIDED|95.0|-16.72|8.83|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Stigma||8.83|-16.72|0.5108
91504692|NCT01480076|182879997|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504693|NCT01480076|182879997|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504694|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0024|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0024
91504695|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0669|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0669
91504696|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0018|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0018
91504697|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
91504698|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.019|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0190
91504699|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0106|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0106
91504700|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
91504701|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.1937|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1937
91504702|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0445|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0445
91504703|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.6475|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6475
91504704|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
91504705|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0386|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0386
91504706|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
91531902|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.0806|TWO_SIDED|95.0|-21.06|1.42|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Social support||1.42|-21.06|0.0806
91504707|NCT01480076|182879997|SUPERIORITY_OR_OTHER|||||||0.0076|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0076
91504708|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.1471|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1471
91504709|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.5503|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5503
91531903|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.4205|TWO_SIDED|95.0|-15.66|7.03|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Cognitive impairment (Cognitions)||7.03|-15.66|0.4205
91748852|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7552|TWO_SIDED|90.0|-0.44|0.64|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.64|-0.44|0.7552
91748853|NCT01730339|183389743|SUPERIORITY_OR_OTHER||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6605|TWO_SIDED|90.0|-0.3|0.52|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.30|0.6605
91748854|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9842|TWO_SIDED|90.0|-0.55|0.56|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.56|-0.55|0.9842
91748855|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.25||0.401|TWO_SIDED|90.0|-0.21|0.63|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.21|0.4010
91748856|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.38||0.2491|TWO_SIDED|90.0|-0.19|1.07|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.07|-0.19|0.2491
91748857|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.998|TWO_SIDED|90.0|-0.47|0.47|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.47|-0.47|0.9980
91748858|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.39||0.473|TWO_SIDED|90.0|-0.37|0.93|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.93|-0.37|0.4730
91748859|NCT01730339|183389743|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.3||0.5413|TWO_SIDED|90.0|-0.67|0.31|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.31|-0.67|0.5413
91748860|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|1.32|STANDARD_ERROR_OF_MEAN|2.76|||TWO_SIDED|90.0|-3.28|5.92||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.92|-3.28|
91748861|NCT01730339|183389744|SUPERIORITY_OR_OTHER||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-3.63|2.91||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.91|-3.63|
91748862|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|3.82|STANDARD_ERROR_OF_MEAN|3.85|||TWO_SIDED|90.0|-2.6|10.24||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||10.24|-2.60|
91748863|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|0.16|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|90.0|-4.37|4.68||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||4.68|-4.37|
91748864|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|90.0|-4.34|2.95||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.95|-4.34|
91748865|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-4.53|1.45||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.45|-4.53|
91748866|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|1.75|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|90.0|-2.07|5.58||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.58|-2.07|
91748867|NCT01730339|183389744|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.87|||TWO_SIDED|90.0|-4.24|1.99||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.99|-4.24|
91748868|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.15|0.35||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.15|
91748869|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.22|0.29||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.29|-0.22|
91748870|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.54|0.04|
91748871|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.36|0.15||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.15|-0.36|
91504710|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.3854|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3854
91504711|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.4893|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4893
91504712|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.2166|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2166
91504713|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.4149|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4149
91748872|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.32|0.82||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.82|0.32|
91504714|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.3849|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3849
91504715|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.898|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8980
91748873|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.21|0.3||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.21|
91748874|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.18|0.68||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|0.18|
91748875|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_DEVIATION|0.15|||TWO_SIDED|90.0|-0.18|0.32||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.18|
91748876|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.39|-0.20|
91748877|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.28|0.23||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.28|
91748878|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.29|0.3||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.29|
91748879|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.18|0.33||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.33|-0.18|
91748880|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.12|0.72||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|0.12|
91748881|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.27|0.24||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.27|
91748882|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.5||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.50|-0.09|
91748883|NCT01730339|183389745|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.11|0.4||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.40|-0.11|
91748884|NCT03989427|183389751|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|1.424||||0.022|TWO_SIDED|95.0|0.221|2.628||The threshold for statistical significance was p \<0.05|ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on BPI scores .||"Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation.~No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores."||2.628|0.221|0.022
91748885|NCT03989427|183389752|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|-0.058||||0.971|TWO_SIDED|95.0|-3.335|3.219|||ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on RMNPI index scores||"Null hypothesis:~The sequence of brushing and flossing has no effect on plaque scores~There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores."||3.219|-3.335|0.971
91748886|NCT04035564|183389757|SUPERIORITY||Risk Ratio (RR)|0.2||||0.71|TWO_SIDED|95.0|0.026|1.533|||Chi-squared|||||1.533|0.026|0.71
91748887|NCT04035564|183389758|SUPERIORITY||Risk Ratio (RR)|1.21||||0.89|TWO_SIDED|95.0|0.081|18.09|||Chi-squared|||||18.09|0.081|0.89
91748888|NCT04035564|183389759|SUPERIORITY||Mean Difference (Final Values)|-2.861|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||t-test, 2 sided|||||-0.261|-5.461|0.032
91748889|NCT04035564|183389759|SUPERIORITY||Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||ANOVA|||||-0.261|-5.461|0.032
91748890|NCT04035564|183389760|SUPERIORITY||Mean Difference (Final Values)|-3.788|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.858|||t-test, 2 sided|||||0.858|-8.43|0.107
91748891|NCT04035564|183389760|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.85|||ANOVA|||||0.85|-8.43|0.107
91748892|NCT04035564|183389761|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||t-test, 2 sided|||||-4.57|-74.18|0.028
91748893|NCT04035564|183389761|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||ANOVA|||||-4.57|-74.18|0.028
91748894|NCT04035564|183389762|SUPERIORITY||Risk Ratio (RR)|0.75||||0.55|TWO_SIDED|95.0|0.296|1.932|||Chi-squared|||||1.932|0.296|0.55
91748895|NCT04035564|183389763|SUPERIORITY||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.169|7.096|||Chi-squared|||||7.096|0.169|0.84
91748896|NCT04035564|183389764|SUPERIORITY||Risk Ratio (RR)|0.8||||0.7|TWO_SIDED|95.0|0.266|2.448|||Chi-squared|||||2.448|0.266|0.70
91748897|NCT04035564|183389765|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
91748898|NCT04035564|183389765|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.57|TWO_SIDED||||||Regression, Cox|||||||0.57
91748899|NCT00939029|183389776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.05|TWO_SIDED|90.0|1.0|7.5||1 tailed p-value|Regression, Logistic|||||7.5|1.0|0.05
91748900|NCT00939029|183389777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.014|TWO_SIDED|90.0|1.4|11.6||1 tailed|Regression, Logistic|||||11.6|1.4|0.014
91748901|NCT00939029|183389778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.087|TWO_SIDED|90.0|0.8|6.0||1 tailed|Regression, Logistic|||||6.0|0.8|0.087
91748902|NCT04686084|183389779|OTHER|Bland-Altman analysis|Median Difference (Final Values)|0.04|||||TWO_SIDED|||||||||||||
91748903|NCT01425359|183389798|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Angina frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.008
91748904|NCT01425359|183389799|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Sublingual nitroglycerin use frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.003
91748905|NCT01528891|183389844|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Heart rate values at each time point were compared between groups.||||<0.01
91504716|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.0046|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0046
91504717|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.0594|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0594
91504718|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.2975|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2975
91748906|NCT01528891|183389844|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
91504719|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.7155|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7155
91504720|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.507|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5070
91504721|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.5848|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5848
91748907|NCT01528891|183389844|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
91748908|NCT01528891|183389845|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P\<0.0001 was calculated for both groups.|Fisher Exact|||The incidence of agitated patients in each group was compared.||||<0.0001
91748909|NCT01528891|183389846|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Systolic blood pressure values were compared between groups at each time point.||||<0.01
91748910|NCT01528891|183389846|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes.~P-values are adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline value within each group over time.||||<0.01
91748911|NCT01528891|183389846|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline within each group over time.||||<0.01
91748912|NCT01528891|183389847|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute and PACU.~P-values were adjusted for multiple comparisons."|t-test, 2 sided|||DBP values were compared between groups at each time point.||||<0.01
91748913|NCT01528891|183389847|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared within each group against the baseline value.||||<0.01
91748914|NCT01528891|183389847|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared against the baseline value within each group over time.||||<0.01
91748915|NCT04452435|183389848|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4891|||||||ANCOVA|||||||=0.4891
91748916|NCT04452435|183389848|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0881|||||||ANCOVA|||A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.||||=0.0881
91748917|NCT04452435|183389849|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0492|||||||ANCOVA|||||||=0.0492
91748918|NCT04452435|183389850|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9923|||||||ANCOVA|||||||=0.9923
91748919|NCT04452435|183389851|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5355|||||||ANCOVA|||||||=0.5355
91504722|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.802|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8020
91504723|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.254|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2540
91504724|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.9057|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9057
91504725|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.9679|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9679
91504726|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.5875|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5875
91504727|NCT01480076|182879998|SUPERIORITY_OR_OTHER|||||||0.744|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7440
91504728|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
91504729|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0828|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0828
91504730|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.7756|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7756
91504731|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.22|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2200
91531904|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-6.1||||0.1065|TWO_SIDED|95.0|-13.63|1.53|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Communication||1.53|-13.63|0.1065
91504732|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
91504733|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0061|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0061
91531905|NCT01767129|182939833|SUPERIORITY||Mean Difference (Final Values)|-5.2||||0.4456|TWO_SIDED|95.0|-19.51|9.19|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Bodily discomfort||9.19|-19.51|0.4456
91504734|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.6258|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6258
91504735|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.6987|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6987
91504736|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0025|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0025
91504737|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
91504738|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.4385|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4385
91504739|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.2275|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2275
91504740|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0446|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0446
91504741|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.5757|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5757
91504742|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.8936|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8936
91531906|NCT01767129|182939834|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0233|TWO_SIDED|95.0|-11.72|-1.07|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||-1.07|-11.72|0.0233
91531907|NCT01767129|182939835|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.193|TWO_SIDED|95.0|-1.39|0.31|||ANOVA|Change from Screening values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||0.31|-1.39|0.1930
91531908|NCT01767129|182939836|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0511|TWO_SIDED|95.0|-2.17|0.01|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Dyskinesia||0.01|-2.17|0.0511
91504743|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.5675|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5675
91504744|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.2539|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2539
91531909|NCT01767129|182939836|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7745|TWO_SIDED|95.0|-0.7|0.91|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Other symptoms||0.91|-0.70|0.7745
91531910|NCT01473420|182939845|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|-0.17|0.24||||||Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.||0.24|-0.17|
91531911|NCT01473420|182939846|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-2.34|STANDARD_ERROR_OF_MEAN|6.175|||TWO_SIDED|95.0|-14.51|9.82||||||LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.||9.82|-14.51|
91531912|NCT01473420|182939847|SUPERIORITY_OR_OTHER|||||||0.8338|||||||Two-sample t-test|||||||0.8338
91504745|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.6673|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6673
91504746|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.0849|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0849
91504747|NCT01480076|182879999|SUPERIORITY_OR_OTHER|||||||0.1187|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1187
91531913|NCT01473420|182939848|SUPERIORITY_OR_OTHER|||||||0.6895|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.6895
91504748|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0022
91504749|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0299|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0299
91504750|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.8135|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8135
91504751|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.3526|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3526
91504752|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
91504753|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0039|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0039
91504754|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.6924|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6924
91504755|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.7639|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7639
91504756|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0013|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0013
91531914|NCT01473420|182939849|SUPERIORITY_OR_OTHER|||||||0.9177|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.9177
91504757|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0011
91748920|NCT04452435|183389852|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4738|||||||ANCOVA|||||||=0.4738
91748921|NCT04452435|183389853|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9418|||||||ANCOVA|||||||=0.9418
91748922|NCT04452435|183389854|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9733|||||||ANCOVA|||||||=0.9733
91748923|NCT04452435|183389855|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0568|||||||Regression, Logistic|||||||=0.0568
91748924|NCT04452435|183389856|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.6088|||||||Regression, Logistic|||||||=0.6088
91748925|NCT04452435|183389857|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5757|||||||Log Rank|||||||=0.5757
91748926|NCT04452435|183389858|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.8588|||||||Wilcoxon (Mann-Whitney)|||||||=0.8588
91748927|NCT04452435|183389860|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.003|||||||Chi-squared|||||||=0.003
91748928|NCT02135029|183389865|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-60.1|-49.0|||MMRM|Mixed Model Repeated Measures (MMRM)|LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group\*visit interaction,baseline value, baseline value\*visit\*group interaction, country.|||-49.0|-60.1|<0.001
91748929|NCT02135029|183389866|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-42.6|-34.2|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-34.2|-42.6|<0.001
91748930|NCT02135029|183389866|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-35.9|-26.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-26.2|-35.9|
91748931|NCT02135029|183389867|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-51.9|-41.1|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-41.1|-51.9|<0.001
91748932|NCT02135029|183389867|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-45.4|-33.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-33.2|-45.4|
91748933|NCT02135029|183389868|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-56.3|-46.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-46.0|-56.3|<0.001
91748934|NCT02135029|183389868|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-47.7|-35.8|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-35.8|-47.7|
91748935|NCT02135029|183389869|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.3|STANDARD_ERROR_OF_MEAN|6.32|<|0.001|TWO_SIDED|95.0|-35.7|-10.8|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-10.8|-35.7|<0.001
91748936|NCT02135029|183389869|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-29.6|-5.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-5.1|-29.6|
91748937|NCT02135029|183389870|SUPERIORITY_OR_OTHER||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|7.8|17.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||17.0|7.8|<0.001
91748938|NCT02135029|183389870|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|6.7|16.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||16.4|6.7|
91504758|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.434|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4340
91504759|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.4224|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4224
91504760|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.1628|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1628
91504761|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.5666|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5666
91504762|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.8315|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8315
91748939|NCT02135029|183389871|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-51.3|-38.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-38.2|-51.3|
91748940|NCT02135029|183389872|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
91748941|NCT02135029|183389872|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
91748942|NCT02135029|183389873|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|2.2|10.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||10.1|2.2|
91748943|NCT02135029|183389873|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|1.5|9.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||9.7|1.5|
91748944|NCT02135029|183389874|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|0.8|8.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.7|0.8|
91748945|NCT02135029|183389874|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|2.4|10.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||10.5|2.4|
91748946|NCT02135029|183389875|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
91748947|NCT02135029|183389875|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
91748948|NCT02135029|183389876|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.8|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-103.5|-84.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-84.1|-103.5|
91748949|NCT02135029|183389877|SUPERIORITY_OR_OTHER||LS Mean Difference|-98.7|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-109.9|-87.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-87.5|-109.9|
91504763|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.3852|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3852
91748950|NCT02135029|183389878|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|3.7|8.0|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.0|3.7|
91748951|NCT02135029|183389879|SUPERIORITY_OR_OTHER||LS Mean Difference|-103.6|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-114.6|-92.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-92.7|-114.6|
91748952|NCT02135029|183389881|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|-66.0|-52.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-52.4|-66.0|
91748953|NCT02135029|183389882|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-8.7|-4.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-4.5|-8.7|
91748954|NCT02135029|183389883|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-2.7|-2.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-2.1|-2.7|
91504764|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.0652|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0652
91504765|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.5719|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5719
91504766|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.9237|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9237
91504767|NCT01480076|182880000|SUPERIORITY_OR_OTHER|||||||0.131|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1310
91531915|NCT01824472|182939917|SUPERIORITY||Mean difference compared across 3 groups|0.43||||0.8|TWO_SIDED||||||Kruskal-Wallis||"Kruskal-Wallis test implemented as PROC NPAR1WAY in Statistical Analysis System (SAS v9.4) for a single groupwise comparison. The mean difference (baseline to follow-up) was determined for each group, and this was compared across all 3 groups."|||||0.8
91504768|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504769|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504770|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
91504771|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0003
91504772|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504773|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504774|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
91504775|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0102
91504776|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504777|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91748955|NCT02135029|183389883|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-2.4|-1.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-1.7|-2.4|
91504778|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
91504779|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0012
91504780|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504781|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504782|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0026|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0026
91504783|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.0161|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0161
91748956|NCT02135029|183389884|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.5|-0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-0.4|-0.5|
91504784|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504785|NCT01480076|182880001|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
91504786|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.1151|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1151
91504787|NCT01480076|182880001|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
91504788|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531916|NCT01815736|182939918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|2.7||||0.051|TWO_SIDED|95.01|-0.3|5.6||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.6|-0.3|0.051
91504789|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.6769|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6769
91504790|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91748957|NCT02135029|183389884|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.4|-0.3|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-0.3|-0.4|
91748958|NCT03520348|183389892|NON_INFERIORITY|It is considered less than 20% of differences between groups to consider non-inferiority||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
91748959|NCT03520348|183389893|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.680
91748960|NCT03520348|183389894|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.839|||||||Wilcoxon (Mann-Whitney)|||||||0.839
91748961|NCT03520348|183389895|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.137|||||||Wilcoxon (Mann-Whitney)|||||||0.137
91748962|NCT03520348|183389897|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.667|||||||Chi-squared, Corrected|||||||0.667
91748963|NCT03520348|183389898|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.561|||||||Chi-squared, Corrected|||||||0.561
91748964|NCT03520348|183389899|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||1|||||||Chi-squared|||||||1.000
91748965|NCT03520348|183389900|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.317|||||||Chi-squared, Corrected|||||||0.317
91748966|NCT03520348|183389901|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.414|||||||Chi-squared, Corrected|||||||0.414
91748967|NCT02292758|183389902|SUPERIORITY||Hazard Ratio (HR)|0.912||||0.7609|TWO_SIDED|95.0|0.431|1.93|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.930|0.431|0.7609
91748968|NCT02292758|183389902|SUPERIORITY||Hazard Ratio (HR)|0.642|||||TWO_SIDED|95.0|0.249|1.656|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.656|0.249|
91748969|NCT02292758|183389905|SUPERIORITY||Hazard Ratio (HR)|0.471||||0.0446|TWO_SIDED|95.0|0.209|1.062|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.062|0.209|0.0446
91748970|NCT02292758|183389905|SUPERIORITY||Hazard Ratio (HR)|0.406|||||TWO_SIDED|95.0|0.151|1.089|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.089|0.151|
91748971|NCT02292758|183389907|SUPERIORITY|||||||0.3415|||||||Chi-squared|||||||0.3415
91748972|NCT02292758|183389908|SUPERIORITY|||||||0.1279|||||||Fisher Exact|||||||0.1279
91504791|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5780
91504792|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|3.4|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504793|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504794|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504795|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.8886|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8886
91504796|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504797|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.3221|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3221
91504798|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91748973|NCT02292758|183389909|SUPERIORITY|||||||0.447|||||||Log Rank|||||||0.447
91748974|NCT02292758|183389910|SUPERIORITY||Hazard Ratio (HR)|0.755||||0.3738|TWO_SIDED|95.0|0.345|1.655|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.655|0.345|0.3738
91748975|NCT02292758|183389911|SUPERIORITY|||||||0.4283|||||||Wilcoxon (Mann-Whitney)|||Cetuximab comparison||||0.4283
91748976|NCT02292758|183389911|SUPERIORITY|||||||0.5262|||||||Wilcoxon (Mann-Whitney)|||Irinotecan comparison||||0.5262
91748977|NCT00385944|183389915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.91|||<|0.001|TWO_SIDED|95.0|-17.02|-8.81|||Mixed Models Analysis|||||-8.81|-17.02|<0.001
91504799|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|5.3|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504800|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504801|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.4668|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4668
91504802|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91748978|NCT00385944|183389916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.81|||<|0.001|TWO_SIDED|95.0|-10.96|-4.65|||Mixed Models Analysis|||||-4.65|-10.96|<0.001
91748979|NCT00385944|183389917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.98|||<|0.001|TWO_SIDED|95.0|-17.06|-6.9|||Mixed Models Analysis|||||-6.90|-17.06|<0.001
91748980|NCT00385944|183389918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.3||||0.001|TWO_SIDED|95.0|-6.84|-1.76|||Mixed Models Analysis|||||-1.76|-6.84|0.001
91748981|NCT00385944|183389919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.16|||<|0.001|TWO_SIDED|95.0|7.05|23.26|||Mixed Models Analysis|||||23.26|7.05|<0.001
91748982|NCT00385944|183389920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.69||||0.001|TWO_SIDED|95.0|5.56|19.81|||Mixed Models Analysis|||||19.81|5.56|0.001
91748983|NCT00385944|183389921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.26||||0.015|TWO_SIDED|95.0|2.17|18.34|||Mixed Models Analysis|||||18.34|2.17|0.015
91748984|NCT00385944|183389922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85||||0.123|TWO_SIDED|95.0|-1.13|8.84|||Mixed Models Analysis|||||8.84|-1.13|0.123
91748985|NCT00385944|183389923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.83|||<|0.001|TWO_SIDED|95.0|-23.05|-10.62|||Mixed Models Analysis|||||-10.62|-23.05|<0.001
91748986|NCT00385944|183389924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.44|||<|0.001|TWO_SIDED|95.0|-70.87|-38.01|||Mixed Models Analysis|||||-38.01|-70.87|<0.001
91748987|NCT00385944|183389926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.5|||<|0.001||95.0|||||two-sided paired t-test|||||||<.001
91748988|NCT00385944|183389927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.011||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.011
91748989|NCT00385944|183389927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.847||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.847
91748990|NCT00385944|183389928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.24||||0.008|TWO_SIDED|95.0|-15.99|-2.49|||t-test, 2 sided|||||-2.49|-15.99|0.008
91748991|NCT00385944|183389929|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.52|||<|0.001|TWO_SIDED|95.0|9.22|25.83|||t-test, 2 sided|||||25.83|9.22|<0.001
91748992|NCT05898672|183389933|OTHER||Ratio of adjusted geometric means|131.18|||||TWO_SIDED|90.0|115.89|148.48||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||148.48|115.89|
91748993|NCT05898672|183389934|OTHER||Ratio of adjusted geometric means|212.44|||||TWO_SIDED|90.0|174.31|258.9||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||258.90|174.31|
91748994|NCT00521599|183389951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.|Mean Difference (Net)|-1.62|STANDARD_DEVIATION|37.0||0.654|TWO_SIDED|95.0|-8.74|5.49|||ANOVA|||Week 8 End scores||5.49|-8.74|0.654
91748995|NCT00521599|183389951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||ANOVA|||Week 8 End scores||||0.003
91748996|NCT00521599|183389951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||Week 8 End scores||||0.001
91748997|NCT01778049|183389958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0013||95.0|-0.52|-0.13|||Mixed Model Repeated Measure (MMRM)|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.|Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.13|-0.52|0.0013
91748998|NCT01778049|183389958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.66|-0.28|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.28|-0.66|<0.0001
91748999|NCT01778049|183389959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.25||0.0103||95.0|-1.15|-0.16|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).|Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.16|-1.15|0.0103
91749000|NCT01778049|183389959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.22||0.0452||95.0|-0.87|-0.01|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.01|-0.87|0.0452
91749001|NCT01218958|183389970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0245|TWO_SIDED|95.0|0.6|0.94||The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).|Andersen-Gill recurrent-event Cox|||"The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.~The method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived."||0.940|0.600|0.0245
91749002|NCT01218958|183389970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0744|TWO_SIDED|95.0|0.677|1.018|||Andersen-Gill recurrent-event Cox model|||||1.018|0.677|0.0744
91749003|NCT01849575|183389986|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
91749004|NCT03359785|183390047|SUPERIORITY||LS Mean Difference|0.278|STANDARD_ERROR_OF_MEAN|0.376||0.2401|ONE_SIDED|90.0|-0.246||||ANOVA||||||-0.246|0.2401
91749005|NCT03359785|183390047|SUPERIORITY||LS Mean Difference|-0.766|STANDARD_ERROR_OF_MEAN|0.547||0.9053|ONE_SIDED|90.0|-1.513||||ANOVA||||||-1.513|0.9053
91749006|NCT01907321|183390055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.78|STANDARD_DEVIATION|14.98||0.001|TWO_SIDED||||||repeated measures ANOVA|||||||.001
91749007|NCT01907321|183390056|SUPERIORITY_OR_OTHER|||||||0.519|||||||ANOVA|||||||.519
91749008|NCT03650803|183390063|OTHER|Significance (alpha) set to 0.05||||||0.046|||||||t-test, 1 sided|||MRF T1 Changes||||0.046
91749009|NCT03650803|183390063|OTHER|Significance (alpha) set to 0.05||||||0.064|||||||t-test, 2 sided|||MRF T2 Changes||||0.064
91749010|NCT03650803|183390064|OTHER|Significance (alpha) set to 0.05||||||0.82|||||||t-test, 2 sided|||MRF T1 relaxation time||||0.820
91749011|NCT03650803|183390064|OTHER|Significance (alpha) set to 0.05||||||0.605|||||||t-test, 2 sided|||MRF T2 relaxation time||||0.605
91749012|NCT00367744|183390065|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment groups were compared for change in limb fat using a two-sided signed rank test||The primary outcome measure was the change in limb fat at 48 weeks between the rosiglitazone and placebo group.||||0.02
91531917|NCT01815736|182939918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|4.1|||<|0.001|TWO_SIDED|95.0|1.6|6.7||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|All Participants||6.7|1.6|<0.001
91504803|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.5695|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5695
91504804|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|2.4|STANDARD_ERROR_OF_MEAN|0.88||0.0058|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0058
91504805|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|1.4||0.001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
91504806|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531918|NCT01815736|182939919|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.078|||<|0.001|TWO_SIDED|95.0|1.697|2.459||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.459|1.697|<0.001
91749013|NCT03664674|183390068|SUPERIORITY||Mean Difference (Net)|-0.221|STANDARD_ERROR_OF_MEAN|0.218||0.312|TWO_SIDED|95.0|-0.648|0.207||Generalized Linear Model - Negative Binomial Regression Model with count data by subject transformed using the log-link function.|Regression, Linear|The parameter estimate + conf. int. results back-transform to the ratio of adjusted mean DVDs (OTO-104/Placebo) to be 0.802 (0.523, 1.230).||||0.207|-0.648|0.312
91749014|NCT04270682|183390168|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed urine 23S-pentol in the adult cohort.|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|0.332|<|0.0001|TWO_SIDED|95.0|-3.794|-2.331|||paired t-test|||||-2.331|-3.794|<0.0001
91504807|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.204|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2040
91504808|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504809|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.6306|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6306
91504810|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non- responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531919|NCT01815736|182939919|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.807|||<|0.001|TWO_SIDED|95.0|1.488|2.126||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.126|1.488|<0.001
91531920|NCT01815736|182939920|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.97|||<|0.001|TWO_SIDED|95.0|1.551|2.39||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.390|1.551|<0.001
91749015|NCT04270682|183390169|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed plasma cholestanol in the adult cohort.|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.241||0.0083|TWO_SIDED|95.0|-1.64|-0.399|||paired t-test|||||-0.399|-1.640|0.0083
91749016|NCT04270682|183390170|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed Plasma 7αC4 in the adult cohort.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-4.193|-3.207|||paired t-test|||||-3.207|-4.193|<0.0001
91749017|NCT04270682|183390171|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.077||||0.0006|TWO_SIDED|95.0|0.0|0.36|||Prescott's|||||0.36|0.00|0.0006
91749018|NCT04270682|183390171|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.62||||0.0006|TWO_SIDED|95.0|0.32|0.86|||Prescott's|||||0.86|0.32|0.0006
91749019|NCT03894969|183390175|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PD is \> 0.667. The anti-PD GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.942|||||TWO_SIDED|0.95|0.765|1.159|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.159|0.765|
91749020|NCT03894969|183390175|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PE is \> 0.667. The anti-PE GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.887|||||TWO_SIDED|0.95|0.719|1.093|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.093|0.719|
91749021|NCT03894969|183390175|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PilA is \> 0.667. The anti-PilA GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.142|||||TWO_SIDED|0.95|0.884|1.474|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.474|0.884|
91749022|NCT03894969|183390175|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-UspA2 is \> 0.667. The anti-UspA2 GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.087|||||TWO_SIDED|0.95|0.948|1.245|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.245|0.948|
91749023|NCT04730635|183390220|OTHER||Posterior Probability|46.3||||||||||||||There was a threshold of ≥2 percentage points. A posterior probability value \>55% was required to satisfy the primary hypothesis.||||
91749024|NCT04730635|183390221|OTHER||Posterior Probability|80.67||||||||||||||There was a threshold of ≤ 0.1 for this standard deviation change. A posterior probability value \>70% was required to satisfy this secondary hypothesis.||||
91749025|NCT04730635|183390222|OTHER||Posterior Probability|98.8||||||||||||||||||
91749026|NCT04762043|183390225|SUPERIORITY||Mean Difference (Final Values)|56.55|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|53.33|59.76|||Mixed Models Analysis|Effect size used for mixed effects model is partial eta-squared (ηp2).||||59.76|53.33|<.001
91504811|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|1.51||0.002|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0020
91504812|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504813|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.4052|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4052
91749027|NCT03070223|183390226|SUPERIORITY||Mean Difference (Net)|-0.1||||0.31|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.10|-0.30|0.31
91749028|NCT03070223|183390228|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.62|TWO_SIDED|95.0|-1.72|2.88|||Regression, Linear||Treatment group difference was estimated using baseline-adjusted linear regression model.|Comparison of Month 24 values||2.88|-1.72|0.62
91749029|NCT03070223|183390229|SUPERIORITY||Mean Difference (Net)|-0.001||||0.61|TWO_SIDED|95.0|-0.007|0.004|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.004|-0.007|0.61
91749030|NCT03070223|183390230|SUPERIORITY||Mean Difference (Net)|-0.028||||0.8|TWO_SIDED|95.0|-0.25|0.19|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.19|-0.25|0.80
91749031|NCT03070223|183390231|SUPERIORITY||Risk Ratio (RR)|1.02||||0.33|TWO_SIDED|95.0|0.98|1.06|||Log-binomial regression using GEE|P-value is from the time and treatment group interaction.|Treatment effect is shown as relative annualized risk of impairment in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.06|0.98|0.33
91749032|NCT03070223|183390232|SUPERIORITY||Mean Difference (Net)|-0.005||||0.18|TWO_SIDED|95.0|-0.013|0.002|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.002|-0.013|0.18
91749033|NCT03070223|183390233|SUPERIORITY||Risk Ratio (RR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24|||Log-binomial regression using GEE|P-value is from the time (before vs. after study treatment initiation) and treatment group interaction.|Treatment effect is shown as relative average risk of impairment over follow-up time in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.24|0.91|0.47
91749034|NCT03070223|183390238|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.55|TWO_SIDED|95.0|-2.7|1.4|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.4|-2.7|0.55
91749035|NCT03070223|183390239|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.67|TWO_SIDED|95.0|-2.8|1.8|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.8|-2.8|0.67
91749036|NCT03070223|183390240|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.5|0.52|||Regression, Linear||Treatment group difference (pitavastatin minus placebo) at Month 24 was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.52|-0.50|0.98
91749037|NCT03070223|183390241|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.31|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.3|-0.8|0.31
91749038|NCT03070223|183390242|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.21|TWO_SIDED|95.0|-0.2|0.9|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.9|-0.2|0.21
91749039|NCT02308163|183390244|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.58||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.58|1.76|<0.001
91504814|NCT01480076|182880002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504815|NCT01480076|182880002|SUPERIORITY_OR_OTHER|||||||0.8626|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8626
91504816|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|0.93||0.0004|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
91749040|NCT02308163|183390244|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.001|TWO_SIDED|95.0|3.56|12.2||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.20|3.56|<0.001
91749041|NCT02308163|183390246|SUPERIORITY||Odds Ratio (OR)|4.79|||<|0.001|TWO_SIDED|95.0|2.14|10.75||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.75|2.14|<0.001
91749042|NCT02308163|183390246|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|3.53|17.5||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.50|3.53|<0.001
91749043|NCT02308163|183390248|SUPERIORITY||Odds Ratio (OR)|39.93|||<|0.001|TWO_SIDED|95.0|5.29|301.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR70-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||301.61|5.29|<0.001
91749044|NCT02308163|183390250|SUPERIORITY||LS mean|-1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.41|-0.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.71|-1.41|<0.001
91749045|NCT02308163|183390250|SUPERIORITY||LS mean|-1.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.86|-1.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.24|-1.86|<0.001
91749046|NCT02308163|183390252|SUPERIORITY||LS mean|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.67|-1.38|<0.001
91749047|NCT02308163|183390252|SUPERIORITY||LS mean|-1.64|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.96|-1.31||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.31|-1.96|<0.001
91749048|NCT02308163|183390254|SUPERIORITY||LS mean|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-6.8|-2.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.4|-6.8|<0.001
91749049|NCT02308163|183390254|SUPERIORITY||LS mean|-6.1|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-8.1|-4.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-4.0|-8.1|<0.001
91749050|NCT02308163|183390256|SUPERIORITY||LS mean|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.6|-1.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.4|-4.6|<0.001
91504817|NCT01480076|182880002|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.49||0.0263|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0263
91749051|NCT02308163|183390256|SUPERIORITY||LS mean|-5.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-6.8|-3.9||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-3.9|-6.8|<0.001
91749052|NCT02308163|183390258|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.31|17.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.67|2.31|<0.001
91749053|NCT02308163|183390258|SUPERIORITY||Odds Ratio (OR)|10.13|||<|0.001|TWO_SIDED|95.0|3.76|27.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||27.27|3.76|<0.001
91749054|NCT02308163|183390260|SUPERIORITY||Odds Ratio (OR)|21.72||||0.003|TWO_SIDED|95.0|2.83|166.66||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||166.66|2.83|0.003
91749055|NCT02308163|183390262|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.001|TWO_SIDED|95.0|2.74|12.29||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.29|2.74|<0.001
91749056|NCT02308163|183390262|SUPERIORITY||Odds Ratio (OR)|9.66|||<|0.001|TWO_SIDED|95.0|4.57|20.41||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||20.41|4.57|<0.001
91749057|NCT02308163|183390264|SUPERIORITY||Odds Ratio (OR)|3.24||||0.012|TWO_SIDED|95.0|1.29|8.12||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.12|1.29|0.012
91749058|NCT02308163|183390264|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|96.0|3.42|19.63||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||19.63|3.42|<0.001
91749059|NCT02308163|183390266|SUPERIORITY||LS Mean|-1.112|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.546|-0.679||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.679|-1.546|<0.001
91749060|NCT02308163|183390266|SUPERIORITY||LS mean|-1.677|STANDARD_ERROR_OF_MEAN|0.221|<|0.001|TWO_SIDED|95.0|-2.114|-1.241||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.241|-2.114|<0.001
91749061|NCT02308163|183390268|SUPERIORITY||LS mean|-10.9|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-15.95|-5.84||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.84|-15.95|<0.001
91749062|NCT02308163|183390268|SUPERIORITY||LS mean|-21.14|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-26.01|-16.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-16.27|-26.01|<0.001
91749063|NCT02308163|183390270|SUPERIORITY||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|2.98|14.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||14.83|2.98|<0.001
91749064|NCT02308163|183390270|SUPERIORITY||Odds Ratio (OR)|10.86|||<|0.001|TWO_SIDED|95.0|4.91|24.03||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||24.03|4.91|<0.001
91749065|NCT02308163|183390272|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.001|TWO_SIDED|95.0|2.38|8.04||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.04|2.38|<0.001
91749066|NCT02308163|183390272|SUPERIORITY||Odds Ratio (OR)|16.78|||<|0.001|TWO_SIDED|95.0|7.31|38.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||38.51|7.31|<0.001
91749067|NCT02308163|183390274|SUPERIORITY||Odds Ratio (OR)|4.29||||0.006|TWO_SIDED|95.0|1.52|12.08||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.08|1.52|0.006
91749068|NCT02308163|183390274|SUPERIORITY||Odds Ratio, log|11.01|||<|0.001|TWO_SIDED|95.0|4.07|29.74||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.74|4.07|<0.001
91749069|NCT02308163|183390276|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.001||95.0|2.11|6.93||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||6.93|2.11|<0.001
91749070|NCT02308163|183390276|SUPERIORITY||Odds Ratio (OR)|13.65|||<|0.001|TWO_SIDED|95.0|6.39|29.17||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.17|6.39|<0.001
91749071|NCT02308163|183390282|SUPERIORITY||LS Mean|-9.94|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-13.66|-6.22||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-6.22|-13.66|<0.001
91749072|NCT02308163|183390282|SUPERIORITY||Odds Ratio (OR)|-14.43|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-17.71|-11.15||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.15|-17.71|<0.001
91749073|NCT02308163|183390286|SUPERIORITY||LS mean|-8.69|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-12.19|-5.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.20|-12.19|<0.001
91749074|NCT02308163|183390286|SUPERIORITY||LS mean|-12.83|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-15.96|-9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.71|-15.96|<0.001
91749075|NCT02308163|183390288|SUPERIORITY||LS mean|-15.2|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-21.4|-9.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.00|-21.40|<0.001
91749076|NCT02308163|183390288|SUPERIORITY||LS mean|-23.14|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-28.78|-17.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.51|-28.78|<0.001
91749077|NCT02308163|183390290|SUPERIORITY||LS mean|-16.88|STANDARD_ERROR_OF_MEAN|3.51|<|0.001|TWO_SIDED|95.0|-23.81|-9.95||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.95|-23.81|<0.001
91749078|NCT02308163|183390290|SUPERIORITY||LS mean|-23.56|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-29.83|-17.28||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.28|-29.83|<0.001
91749079|NCT02308163|183390292|SUPERIORITY||LS mean|-17.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.36|-10.81||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.81|-24.36|<0.001
91504818|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504819|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.8999|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8999
91504820|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504821|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.7156|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7156
91504822|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|2.9|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0050
91504823|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.68||0.049|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0490
91504824|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504825|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.274|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
91504826|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504827|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.5556|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5556
91504828|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|5.2|STANDARD_ERROR_OF_MEAN|1.15|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504829|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|3.7|STANDARD_ERROR_OF_MEAN|1.88||0.0476|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0476
91504830|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504831|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.8627|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8627
91504832|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749080|NCT02308163|183390292|SUPERIORITY||LS mean|-23.9|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-30.24|-17.57||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.57|-30.24|<0.001
91749081|NCT02308163|183390294|SUPERIORITY|||||||0.033||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.033
91749082|NCT02308163|183390294|SUPERIORITY|||||||0.035||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.035
91504833|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.4312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4312
91504834|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.27||0.0305|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0305
91504835|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|2.6|STANDARD_ERROR_OF_MEAN|2.03||0.2059|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2059
91504836|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.0008|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0008
91504837|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.3685|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3685
91504838|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
91504839|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.9862|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9862
91504840|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.38||0.5561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5561
91531921|NCT01815736|182939920|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.0|||<|0.001|TWO_SIDED|95.0|1.549|2.452||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.452|1.549|<0.001
91504841|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|2.32||0.2281|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2281
91504842|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0006
91504843|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.6004|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6004
91504844|NCT01480076|182880003|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504845|NCT01480076|182880003|SUPERIORITY_OR_OTHER|||||||0.904|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9040
91749083|NCT02308163|183390295|SUPERIORITY||LS mean|-0.34|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.20|-0.48|<0.001
91749084|NCT02308163|183390295|SUPERIORITY||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.26|-0.53|<0.001
91749085|NCT02308163|183390297|SUPERIORITY||LS mean|6.87|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|3.69|10.05||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.05|3.69|<0.001
91749086|NCT02308163|183390297|SUPERIORITY||LS mean|6.98|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|4.11|9.85||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.85|4.11|<0.001
91749087|NCT02308163|183390299|SUPERIORITY||LS mean|2.89|STANDARD_ERROR_OF_MEAN|1.0||0.004|TWO_SIDED|95.0|0.91|4.87||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||4.87|0.91|0.004
91749088|NCT02308163|183390299|SUPERIORITY||LS mean|3.25|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|1.3|5.19||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.19|1.30|0.001
91749089|NCT02308163|183390301|SUPERIORITY||LS mean|2.27|STANDARD_ERROR_OF_MEAN|1.8||0.21|TWO_SIDED|95.0|-1.29|5.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.83|-1.29|0.210
91749090|NCT02308163|183390301|SUPERIORITY||LS mean|6.23|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|2.74|9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.71|2.74|<0.001
91749091|NCT02308163|183390303|SUPERIORITY||LS mean|-8.55|STANDARD_ERROR_OF_MEAN|3.81||0.027|TWO_SIDED|95.0|-16.11|-1.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.00|-16.11|0.027
91749092|NCT02308163|183390303|SUPERIORITY||LS mean|-10.17|STANDARD_ERROR_OF_MEAN|3.88||0.01|TWO_SIDED|95.0|-17.88|-2.47||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.47|-17.88|0.010
91749093|NCT02308163|183390305|SUPERIORITY||LS mean|-20.67|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-30.44|-10.89||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.89|-30.44|<0.001
91749094|NCT02308163|183390305|SUPERIORITY||LS mean|-22.01|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.06|-11.97||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.97|-32.06|<0.001
91749095|NCT02308163|183390307|SUPERIORITY||LS mean|-20.22|STANDARD_ERROR_OF_MEAN|5.12|<|0.001|TWO_SIDED|95.0|-30.38|-10.06||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.06|-30.38|<0.001
91749096|NCT02308163|183390307|SUPERIORITY||LS mean|-23.67|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-34.16|-13.17|||Covariance model|No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-13.17|-34.16|<0.001
91749097|NCT02308163|183390309|SUPERIORITY||LS mean|-17.3|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-24.0|-10.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.61|-24.00|<0.001
91749098|NCT02308163|183390309|SUPERIORITY||LS mean|-20.41|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-26.59|-14.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-14.24|-26.59|<0.001
91749099|NCT03219034|183390320|SUPERIORITY||Median Difference (Final Values)|3.8||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.||||0.152
91749100|NCT00118846|183390322|SUPERIORITY||Slope|-0.91||||0.35|TWO_SIDED|95.0|-2.86|1.05|||Mixed Models Analysis||Slope = Mean difference in annualized rate of change|||1.05|-2.86|0.35
91749101|NCT00118846|183390323|OTHER||Mean Difference (Net)|0.11||||0.36|TWO_SIDED|95.0|-0.13|0.35|||ANCOVA|||||0.35|-0.13|0.36
91749102|NCT00443053|183390326|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Fisher Exact|||||0.26|0.08|<0.001
91749103|NCT00443053|183390327|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.32|||Fisher Exact|||||0.32|0.12|<0.001
91749104|NCT04098367|183390407|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.6|||||TWO_SIDED|97.5|13.34|46.79|||Miettinen-Nurminen||VIVITY minus SYMFONY|||46.79|13.34|
91749105|NCT04098367|183390407|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.1|||||TWO_SIDED|97.5|12.54|46.68|||Miettinen-Nurminen||VIVITY minus AT LARA|||46.68|12.54|
91749106|NCT04098367|183390408|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|-2.3|||||TWO_SIDED|97.5|-21.91|17.42|||Miettinen-Nurminen||VIVITY minus SYMFONY|||17.42|-21.91|
91749107|NCT04098367|183390408|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|8.2|||||TWO_SIDED|97.5|-12.0|27.8|||Miettinen-Nurminen||VIVITY minus AT LARA|||27.80|-12.00|
91749108|NCT04098367|183390409|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|23.5|||||TWO_SIDED|97.5|4.66|40.86|||Miettinen-Nurminen||VIVITY minus SYMFONY|||40.86|4.66|
91749109|NCT04098367|183390409|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|40.7|||||TWO_SIDED|97.5|21.16|57.22|||Miettinen-Nurminen||VIVITY minus AT LARA|||57.22|21.16|
91749110|NCT01545232|183390410|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.75||||0.12|TWO_SIDED|95.0|0.52|1.08|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. \& given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.||1.08|0.52|0.12
91749111|NCT01545232|183390411|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial's adaptive design. With 680 patients \& given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.||1.12|0.65|0.26
91749112|NCT01545232|183390413|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||van Elteren's test for medians|||||||0.83
91749113|NCT01545232|183390414|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||van Elteren's test for medians|||||||0.44
91749114|NCT01545232|183390416|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||van Elteren's test for medians|||||||0.11
91749115|NCT01545232|183390417|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.8|8.3||||||||8.3|-2.8|
91749116|NCT01545232|183390418|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.7||||||||1.7|-0.8|
91749117|NCT01545232|183390419|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||generalized logit model regression|||||||0.37
91749118|NCT01545232|183390420|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||van Elteren's test for medians|||||||0.14
91749119|NCT01545232|183390421|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||van Elteren's test for medians|||||||0.10
91749120|NCT01106859|183390451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.0174|TWO_SIDED|95.0|0.1|1.5||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups.||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) - LS mean of SDLP (Placebo).||1.5|0.1|0.0174
91749121|NCT01106859|183390451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.8|2.1||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) - LS mean of SDLP (Placebo).||2.1|0.8|<0.0001
91749122|NCT01106859|183390451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.1||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) - LS mean of SDLP (Placebo).||3.1|1.8|<0.0001
91749123|NCT01106859|183390452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.0145|TWO_SIDED|95.0|0.03|0.27||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) - LS mean of SDS (Placebo).||0.27|0.03|0.0145
91749124|NCT01106859|183390452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.2179|TWO_SIDED|95.0|-0.05|0.2||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) - LS mean of SDS (Placebo).||0.20|-0.05|0.2179
91749125|NCT01106859|183390452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.0096|TWO_SIDED|95.0|0.04|0.29||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) - LS mean of SDS (Placebo).||0.29|0.04|0.0096
91749126|NCT01106859|183390455|SUPERIORITY_OR_OTHER|||||||0.2188||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.2188
91749127|NCT01106859|183390455|SUPERIORITY_OR_OTHER|||||||0.0117||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0117
91749128|NCT01106859|183390455|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
91749129|NCT01106859|183390457|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.1250
91749130|NCT01106859|183390457|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0074
91749131|NCT01106859|183390457|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
91749132|NCT01106859|183390459|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.5000
91504846|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.38||0.0401|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0401
91749133|NCT01106859|183390459|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0156
91749134|NCT01106859|183390459|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0001
91749135|NCT01007435|183390496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.77|||<|0.0001|TWO_SIDED|95.0|3.19|7.14||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.||7.14|3.19|<0.0001
91749136|NCT01007435|183390496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.47|5.55||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.||5.55|2.47|<0.0001
91749137|NCT01007435|183390496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72|||<|0.0001|TWO_SIDED|95.0|1.8|4.11||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.||4.11|1.80|<0.0001
91749138|NCT03575065|183390555|SUPERIORITY|||||||0.021||||||p-value was based on an exact binomial test with historic control ORR=0.25|Exact Binomial Test|||||||0.0210
91749139|NCT00496197|183390604|SUPERIORITY_OR_OTHER||percentage of participants|83.7|||||TWO_SIDED|95.0|78.7|88.8|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||88.8|78.7|
91749140|NCT00496197|183390605|SUPERIORITY_OR_OTHER||percentage of participants|93.0|||||TWO_SIDED|95.0|89.4|96.7|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOT||96.7|89.4|
91749141|NCT00496197|183390606|SUPERIORITY_OR_OTHER||percentage of participants|95.3|||||TWO_SIDED|95.0|92.3|98.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOT||98.3|92.3|
91749142|NCT00496197|183390607|SUPERIORITY_OR_OTHER||percentage of participants|88.5|||||TWO_SIDED|95.0|84.4|92.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||92.6|84.4|
91749143|NCT00496197|183390608|SUPERIORITY_OR_OTHER||percentage of participants|93.1|||||TWO_SIDED|95.0|89.8|96.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOIV||96.4|89.8|
91749144|NCT00496197|183390609|SUPERIORITY_OR_OTHER||percentage of participants|92.6|||||TWO_SIDED|95.0|89.3|95.9|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOIV||95.9|89.3|
91749145|NCT00496197|183390610|SUPERIORITY_OR_OTHER||percentage of participants|76.3|||||TWO_SIDED|95.0|70.3|82.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||82.3|70.3|
91749146|NCT00496197|183390611|SUPERIORITY_OR_OTHER||percentage of participants|94.8|||||TWO_SIDED|95.0|91.5|98.1|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 2 Follow-up||98.1|91.5|
91749147|NCT00496197|183390612|SUPERIORITY_OR_OTHER||percentage of participants|95.4|||||TWO_SIDED|95.0|92.2|98.5|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 2 Follow-up||98.5|92.2|
91749148|NCT00496197|183390613|SUPERIORITY_OR_OTHER||percentage of participants|70.1|||||TWO_SIDED|95.0|63.5|76.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.6|63.5|
91504847|NCT01480076|182880003|SUPERIORITY_OR_OTHER||difference of LS means|4.1|STANDARD_ERROR_OF_MEAN|2.23||0.0651|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0651
91749149|NCT00496197|183390614|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 6 Follow-up (EOS)||97.4|89.7|
91749150|NCT00496197|183390615|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 6 Follow-up (EOS)||97.4|89.7|
91749151|NCT00496197|183390616|SUPERIORITY_OR_OTHER||percentage of participants|82.5|||||TWO_SIDED|95.0|75.7|89.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||89.3|75.7|
91749152|NCT00496197|183390617|SUPERIORITY_OR_OTHER||percentage of participants|85.6|||||TWO_SIDED|95.0|79.8|91.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||91.4|79.8|
91749153|NCT00496197|183390618|SUPERIORITY_OR_OTHER||percentage of participants|76.7|||||TWO_SIDED|95.0|69.0|84.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||84.4|69.0|
91749154|NCT00496197|183390619|SUPERIORITY_OR_OTHER||percentage of participants|67.6|||||TWO_SIDED|95.0|58.9|76.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.3|58.9|
91749155|NCT00934947|183390677|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||.36
91749156|NCT00934947|183390678|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||.32
91749157|NCT00934947|183390679|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||.48
91749158|NCT04077996|183390680|NON_INFERIORITY|The margin of non inferiority analysis was established at 30%.|Risk Ratio (RR)|1.11|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|0.91|1.3|||Chi-squared, Corrected|||Summary statistics were computed, and a significance level (α) of 5% has been established.||1.3|0.91|<0.05
91749159|NCT04077996|183390680|NON_INFERIORITY|margin 30%|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
91504848|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749160|NCT04077996|183390681|NON_INFERIORITY|The margin was established at 30%.|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|1.0|0.14|6.6|||Fisher Exact|||||6.6|0.14|<0.05
91749161|NCT00252694|183390689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1994|TWO_SIDED|95.0|0.704|1.076|||Log Rank|Generalized||||1.076|0.704|0.1994
91749162|NCT01468233|183390742|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|31.5|||<|0.001|TWO_SIDED|95.0|20.7|42.2||P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||42.2|20.7|<0.001
91749163|NCT01468233|183390742|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.5|||<|0.001|TWO_SIDED|95.0|10.5|40.5||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||40.5|10.5|<0.001
91749164|NCT01468233|183390742|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|38.1|||<|0.001|TWO_SIDED|95.0|22.8|53.3||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||53.3|22.8|<0.001
91749165|NCT01468233|183390743|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|19.5|||=|0.01|TWO_SIDED|95.0|4.7|34.2||P-value adjusted for baseline antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||34.2|4.7|=0.01
91749166|NCT01468233|183390744|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.1|||<|0.001|TWO_SIDED|95.0|12.7|37.6||P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||37.6|12.7|<0.001
91749167|NCT01468233|183390745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.4|||<|0.001|TWO_SIDED|95.0|-28.6|-10.1||P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.|ANCOVA|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||-10.1|-28.6|<0.001
91749168|NCT01574157|183390746|SUPERIORITY||Mean Difference (Final Values)|12.6|||||TWO_SIDED|95.0|-9.6|40.1||||||The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||40.1|-9.6|
91504849|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.454|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4540
91504850|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504851|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.2949|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2949
91504852|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-8.1|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749169|NCT01574157|183390747|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-38.2|30.8||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||30.8|-38.2|
91749170|NCT01574157|183390748|SUPERIORITY||Mean Difference (Final Values)|-32.5|||||TWO_SIDED|95.0|-56.3|4.2||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||4.2|-56.3|
91749171|NCT01574157|183390749|SUPERIORITY||Mean Difference (Final Values)|7.7|||||TWO_SIDED|95.0|-15.1|36.5||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||36.5|-15.1|
91749172|NCT01574157|183390750|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-24.6|35.9||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||35.9|-24.6|
91749173|NCT01574157|183390751|SUPERIORITY||Mean Difference (Final Values)|3.37|||||TWO_SIDED|95.0|-0.05|6.79||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||6.79|-0.05|
91749174|NCT02136680|183390759|SUPERIORITY||Regression Coefficient|0.046||||0.4|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.400
91749175|NCT02136680|183390759|SUPERIORITY||Regression Coefficient|0.119||||0.022|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.022
91749176|NCT02136680|183390759|SUPERIORITY||Regression Coefficient|-0.003||||0.347|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.347
91749177|NCT02136680|183390760|SUPERIORITY||Regression Coefficient|-0.003||||0.959|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.959
91749178|NCT02136680|183390760|SUPERIORITY||Regression Coefficient|0.143||||0.021|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.021
91749179|NCT02136680|183390760|SUPERIORITY||Regression Coefficient|0.048||||0.454|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.454
91749180|NCT02136680|183390760|SUPERIORITY||Regression Coefficient|-0.015||||0.774|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to First Follow-up||||0.774
91749181|NCT02136680|183390760|SUPERIORITY||Regression Coefficient|0.137||||0.018|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.018
91749182|NCT02136680|183390760|SUPERIORITY||Regression Coefficient|0.051||||0.362|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.362
91749183|NCT02136680|183390761|SUPERIORITY||Regression Coefficient|-0.072||||0.213|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.213
91749184|NCT02136680|183390761|SUPERIORITY||Regression Coefficient|0.037||||0.561|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.561
91749185|NCT02136680|183390761|SUPERIORITY|Change in Palliative Outcomes from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|Regression Coefficient|0.165||||0.008|TWO_SIDED||||||Regression, Linear|||||||0.008
91749186|NCT01632241|183390764|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1068|TWO_SIDED|95.0|0.93|2.11|||Regression, Logistic|||||2.11|0.93|0.1068
91749187|NCT01632241|183390773|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0937|TWO_SIDED|95.0|0.94|2.15||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.15|0.94|0.0937
91749188|NCT01632241|183390775|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.2264|TWO_SIDED|95.0|0.51|1.17||Nominal p-value due to step-down sequential testing procedure.|Cox proportional hazards model|||||1.17|0.51|0.2264
91749189|NCT01632241|183390777|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4996|TWO_SIDED|95.0|0.61|2.8||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.80|0.61|0.4996
91749190|NCT03111550|183390809|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)||||||0.02041|ONE_SIDED||||||Exact test on binomial distribution|||||||0.02041
91749191|NCT03111550|183390810|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)||||||0.1969|ONE_SIDED|||||For ZQR00 retinal detachment|Exact test on binomial distribution|||||||0.1969
91749192|NCT03111550|183390810|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4655|ONE_SIDED|||||For ZHR00 secondary surgical intervention|Exact test of binomial distribution|||||||0.4655
91749193|NCT03111550|183390810|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.021|ONE_SIDED|||||For ZQR00 secondary surgical intention|Exact test on binomial distribution|||||||0.0210
91749194|NCT03111550|183390810|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4698|ONE_SIDED|||||For ZXR00 secondary surgical intervention|Exact test on binomial distribution|||||||0.4698
91504853|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-9.0|STANDARD_ERROR_OF_MEAN|3.16||0.0046|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0046
91504854|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-12.6|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504855|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.502|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5020
91504856|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749195|NCT01686750|183390838|SUPERIORITY||Risk Ratio (RR)|1.31||||0.09|TWO_SIDED|95.0|0.95|1.81|||Prevalence ratio||Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.|We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.||1.81|0.95|0.09
91749196|NCT01686750|183390839|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.8|1.5||||||||1.50|0.80|
91749197|NCT01686750|183390840|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.81||||||||1.81|0.61|
91749198|NCT01686750|183390841|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.77|2.41||||||||2.41|0.77|
91749199|NCT01686750|183390843|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.28||||||||1.28|0.65|
91749200|NCT01686750|183390845|SUPERIORITY||Risk Ratio, log|1.44|||||TWO_SIDED|95.0|0.42|4.93||||||||4.93|0.42|
91749201|NCT01686750|183390846|SUPERIORITY||Risk Ratio, log|1.87|||||TWO_SIDED|95.0|0.49|7.16||||||||7.16|0.49|
91749202|NCT01686750|183390847|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.53|1.56||||||||1.56|0.53|
91749203|NCT01686750|183390848|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-4.2|4.2||||||||4.2|-4.2|
91749204|NCT01686750|183390850|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.47|1.52||||||||1.52|0.47|
91749205|NCT01686750|183390852|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.0|-0.6||||||||-0.6|-3.0|
91749206|NCT01686750|183390853|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
91749207|NCT02956044|183390855|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|108.73|||||TWO_SIDED|95.0|94.35|125.3|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric Least Square (LS) Mean was used as PK parameters||125.30|94.35|
91749208|NCT02956044|183390855|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|95.05|||||TWO_SIDED|90.0|84.73|106.63|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||106.63|84.73|
91749209|NCT02956044|183390855|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|89.44|||||TWO_SIDED|90.0|70.39|113.65|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||113.65|70.39|
91749210|NCT02956044|183390855|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|111.95|||||TWO_SIDED|90.0|97.02|129.19|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||129.19|97.02|
91749211|NCT02956044|183390855|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|126.68|||||TWO_SIDED|90.0|112.08|143.17|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||143.17|112.08|
91749212|NCT02956044|183390855|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|98.48|||||TWO_SIDED|90.0|84.9|114.23|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||114.23|84.90|
91749213|NCT02956044|183390858|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|87.36|||||TWO_SIDED|90.0|80.02|95.38|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||95.38|80.02|
91749214|NCT02956044|183390858|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|103.24|||||TWO_SIDED|90.0|94.59|112.68|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||112.68|94.59|
91749215|NCT02956044|183390858|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|94.46|||||TWO_SIDED|90.0|80.34|111.06|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||111.06|80.34|
91504857|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.2157|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2157
91504858|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-11.2|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504859|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-10.0|STANDARD_ERROR_OF_MEAN|3.3||0.0026|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
91749216|NCT02956044|183390858|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|[Ratio of Geometric LSM]|127.19|||||TWO_SIDED|90.0|110.33|146.62|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||146.62|110.33|
91504860|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504861|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.3435|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3435
91504862|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504863|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.1357|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1357
91749217|NCT02956044|183390858|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|113.09|||||TWO_SIDED|90.0|107.61|118.86|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||118.86|107.61|
91749218|NCT02956044|183390858|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|103.16|||||TWO_SIDED|90.0|99.3|107.17||||||Geometric LS Mean was used as PK parameters|Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|107.17|99.30|
91531922|NCT01815736|182939921|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.03||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|NDA Data Cut||-0.03|-0.07|<0.001
91749219|NCT03832114|183390860|OTHER|Log Ratio to Baseline|Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||||0.65|0.46|0.0003
91749220|NCT03832114|183390861|OTHER||Median Difference (Final Values)|-2.5||||0.0313|TWO_SIDED|80.0|-3.75|-0.75|||Wilcoxon (Mann-Whitney)|||||-0.75|-3.75|0.0313
91749221|NCT03832114|183390862|OTHER||Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.65|0.46|0.0003
91749222|NCT03832114|183390862|OTHER||Mean Difference (Final Values)|0.79||||0.4766|TWO_SIDED|80.0|0.49|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.28|0.49|0.4766
91749223|NCT03832114|183390862|OTHER||Mean Difference (Final Values)|0.59||||0.0002|TWO_SIDED|80.0|0.51|0.69|||Mixed Model of Repeated Measures (MMRM)|||Overall- Day 84||0.69|0.51|0.0002
91749224|NCT03832114|183390863|OTHER||Mean Difference (Final Values)|0.57||||0.0011|TWO_SIDED|80.0|0.47|0.68|||Mixed Model Repeated Measures (MMRM|||Day 84||0.68|0.47|0.0011
91749225|NCT03832114|183390863|OTHER||Mean Difference (Final Values)|1.0||||0.9998|TWO_SIDED|80.0|0.75|1.33|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.33|0.75|0.9998
91749226|NCT03832114|183390863|OTHER||Mean Difference (Final Values)|0.66||||0.0016|TWO_SIDED|80.0|0.56|0.77|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.77|0.56|0.0016
91749227|NCT03832114|183390864|OTHER||Mean Difference (Final Values)|0.55|||<|0.0001|TWO_SIDED|80.0|0.47|0.64|||Mixed Model Repeated Measures (MRM)|||Day 84||0.64|0.47|<0.0001
91749228|NCT03832114|183390864|OTHER||Mean Difference (Final Values)|0.61||||0.3707|TWO_SIDED|80.0|0.3|1.27|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.27|0.30|0.3707
91749229|NCT03832114|183390864|OTHER||Mean Difference (Final Values)|0.6||||0.0002|TWO_SIDED|80.0|0.51|0.71|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.71|0.51|0.0002
91749230|NCT03832114|183390865|OTHER||Mean Difference (Final Values)|0.57||||0.0018|TWO_SIDED|80.0|0.47|0.7|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.70|0.47|0.0018
91749231|NCT03832114|183390865|OTHER||Mean Difference (Final Values)|0.81||||0.1632|TWO_SIDED|80.0|0.67|0.98|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.98|0.67|0.1632
91749232|NCT03832114|183390865|OTHER||Mean Difference (Final Values)|0.67||||0.004|TWO_SIDED|80.0|0.57|0.79|||Mixed Model Repeated Measure (MMRM)|||Overall- Day 84||0.79|0.57|0.0040
91749233|NCT03832114|183390866|OTHER||Mean Difference (Final Values)|2.59||||0.1795|TWO_SIDED|80.0|0.12|5.06|||Mixed Model of Repeated Measures (MMRM)|||Day 84||5.06|0.12|0.1795
91749234|NCT03832114|183390866|OTHER||Mean Difference (Final Values)|-0.61||||0.7763|TWO_SIDED|0.7763|-3.36|2.15|||Mixed Model Repeated Measures (MMRM)|||Day 84||2.15|-3.36|0.7763
91749235|NCT03832114|183390866|OTHER||Mean Difference (Final Values)|1.32||||0.3754|TWO_SIDED|80.0|-0.59|3.22|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||3.22|-0.59|0.3754
91749236|NCT03832114|183390867|OTHER||Mean Difference (Final Values)|-5.04||||0.1364|TWO_SIDED|80.0|-9.36|-0.72|||Mixed Model Repeated Measuers (MMRM)|||Day 84||-0.72|-9.36|0.1364
91749237|NCT03832114|183390867|OTHER||Mean Difference (Final Values)|7.17||||0.3038|TWO_SIDED|80.0|-1.79|16.13|||Mixed Model Repeated Measures (MMRM)|||Day 84||16.13|-1.79|0.3038
91749238|NCT03832114|183390867|OTHER||Mean Difference (Final Values)|-0.77||||0.8352|TWO_SIDED|80.0|-5.56|4.01|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||4.01|-5.56|0.8352
91749239|NCT03832114|183390868|OTHER||Mean Difference (Final Values)|1.07||||0.2752|TWO_SIDED|80.0|0.99|1.17|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.17|0.99|0.2752
91749240|NCT03832114|183390868|OTHER||Mean Difference (Final Values)|1.2||||0.476|TWO_SIDED|80.0|0.83|1.72|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.72|0.83|0.476
91749241|NCT03832114|183390868|OTHER||Mean Difference (Final Values)|1.1||||0.1963|TWO_SIDED|80.0|1.0|1.2|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||1.20|1.00|0.1963
91749242|NCT03832114|183390870|OTHER||Mean Difference (Final Values)|0.56|||<|0.0001|TWO_SIDED|80.0|0.48|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.65|0.48|<0.0001
91749243|NCT03832114|183390870|OTHER||Mean Difference (Final Values)|0.99||||0.9544|TWO_SIDED|80.0|0.76|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.28|0.76|0.9544
91749244|NCT03832114|183390870|OTHER||Mean Difference (Final Values)|0.64|||<|0.0001|TWO_SIDED|80.0|0.56|0.72|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.72|0.56|<.0001
91749245|NCT03832114|183390871|OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|80.0|0.5|0.69|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.69|0.50|<.0001
91749246|NCT03832114|183390871|OTHER||Median Difference (Final Values)|0.87||||0.6209|TWO_SIDED|80.0|0.6|1.26|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.26|0.60|0.6209
91749247|NCT03832114|183390871|OTHER||Mean Difference (Final Values)|0.63||||0.0002|TWO_SIDED|80.0|0.54|0.73|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.73|0.54|0.0002
91749248|NCT01939002|183390891|SUPERIORITY_OR_OTHER||||||<|0.0001||||||1-sample Chi-square test comparing to Null hypotheses at 25%.|Chi-squared|||||||<0.0001
91749249|NCT01939002|183390892|SUPERIORITY_OR_OTHER|||||||0.2037||||||Chi-square test between 2 treatment arms.|Chi-squared|||||||0.2037
91749250|NCT01939002|183390894|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.||||||1.00
91749251|NCT01939002|183390894|SUPERIORITY_OR_OTHER|||||||0.5078|||||||McNemar|||||||0.5078
91749252|NCT01939002|183390894|SUPERIORITY_OR_OTHER|||||||0.5811|||||||McNemar|||||||0.5811
91749253|NCT01939002|183390895|SUPERIORITY_OR_OTHER|||||||0.0525|||||||McNemar|||||||0.0525
91749254|NCT01939002|183390895|SUPERIORITY_OR_OTHER|||||||0.0654|||||||McNemar|||||||0.0654
91749255|NCT01939002|183390895|SUPERIORITY_OR_OTHER|||||||0.5488|||||||McNemar|||||||0.5488
91749256|NCT01939002|183390896|SUPERIORITY_OR_OTHER|||||||0.0945|||||||paired t-test within 1 arm|||||||0.0945
91749257|NCT01939002|183390896|SUPERIORITY_OR_OTHER|||||||0.8246|||||||paired t-test within 1 arm|||||||0.8246
91749258|NCT01939002|183390896|SUPERIORITY_OR_OTHER|||||||0.2533|||||||paired t-test within 1 arm|||||||0.2533
91749259|NCT01939002|183390896|SUPERIORITY_OR_OTHER|||||||0.1631|||||||2-sample t-test between 2 arms|||||||0.1631
91749260|NCT01939002|183390897|SUPERIORITY_OR_OTHER|||||||0.3189|||||||paired t-test within 1 arm|||||||0.3189
91749261|NCT01939002|183390897|SUPERIORITY_OR_OTHER|||||||0.3582|||||||paired t-test within 1 arm|||||||0.3582
91749262|NCT01939002|183390897|SUPERIORITY_OR_OTHER|||||||0.8484|||||||paired t-test within 1 arm|||||||0.8484
91749263|NCT01939002|183390897|SUPERIORITY_OR_OTHER|||||||0.1771|||||||2-sample t-test between 2 arms|||||||0.1771
91749264|NCT01939002|183390898|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
91749265|NCT01939002|183390898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
91749266|NCT01939002|183390898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
91749267|NCT01939002|183390898|SUPERIORITY_OR_OTHER|||||||0.3792|||||||2-sample t-test between 2 arms|||||||0.3792
91749268|NCT01939002|183390899|SUPERIORITY_OR_OTHER|||||||0.0019|||||||paired t-test within 1 arm|||||||0.0019
91749269|NCT01939002|183390899|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
91749270|NCT01939002|183390899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
91749271|NCT01939002|183390900|SUPERIORITY_OR_OTHER|||||||0.0105|||||||paired t-test within 1 arm|||||||0.0105
91749272|NCT01939002|183390900|SUPERIORITY_OR_OTHER|||||||0.0789|||||||paired t-test within 1 arm|||||||0.0789
91749273|NCT01939002|183390900|SUPERIORITY_OR_OTHER|||||||0.0027|||||||paired t-test within 1 arm|||||||0.0027
91749274|NCT01939002|183390900|SUPERIORITY_OR_OTHER|||||||0.838|||||||2-sample t-test between 2 arms|||||||0.8380
91749275|NCT01939002|183390901|SUPERIORITY_OR_OTHER|||||||0.1407|||||||paired t-test within 1 arm|||||||0.1407
91749276|NCT01939002|183390901|SUPERIORITY_OR_OTHER|||||||0.7805|||||||paired t-test within 1 arm|||||||0.7805
91749277|NCT01939002|183390901|SUPERIORITY_OR_OTHER|||||||0.2186|||||||paired t-test within 1 arm|||||||0.2186
91749278|NCT01939002|183390901|SUPERIORITY_OR_OTHER|||||||0.4234|||||||2-sample t-test between 2 arms|||||||0.4234
91749279|NCT01939002|183390902|SUPERIORITY_OR_OTHER|||||||0.009|||||||paired t-test within 1 arm|||||||0.0090
91749280|NCT01939002|183390902|SUPERIORITY_OR_OTHER|||||||0.0075|||||||paired t-test within 1 arm|||||||0.0075
91749281|NCT01939002|183390902|SUPERIORITY_OR_OTHER|||||||0.0002|||||||paired t-test within 1 arm|||||||0.0002
91749282|NCT01939002|183390902|SUPERIORITY_OR_OTHER|||||||0.7497|||||||2-sample t-test between 2 arms|||||||0.7497
91749283|NCT01939002|183390903|SUPERIORITY_OR_OTHER|||||||0.0545|||||||paired t-test within 1 arm|||||||0.0545
91749284|NCT01939002|183390903|SUPERIORITY_OR_OTHER|||||||0.3377|||||||paired t-test within 1 arm|||||||0.3377
91749285|NCT01939002|183390903|SUPERIORITY_OR_OTHER|||||||0.0391|||||||paired t-test within 1 arm|||||||0.0391
91749286|NCT01939002|183390903|SUPERIORITY_OR_OTHER|||||||0.4861|||||||2-sample t-test between 2 arms|||||||0.4861
91749287|NCT01939002|183390904|SUPERIORITY_OR_OTHER|||||||0.0834|||||||Fisher Exact|||first 8 weeks||||0.0834
91749288|NCT01939002|183390904|SUPERIORITY_OR_OTHER|||||||0.0767|||||||Fisher Exact|||Weeks 0-2||||0.0767
91749289|NCT01939002|183390904|SUPERIORITY_OR_OTHER|||||||0.732|||||||Fisher Exact|||Weeks 3-4||||0.7320
91749290|NCT01939002|183390904|SUPERIORITY_OR_OTHER|||||||0.5008|||||||Fisher Exact|||Weeks 5-6||||0.5008
91749291|NCT01939002|183390904|SUPERIORITY_OR_OTHER|||||||0.6422|||||||Fisher Exact|||Weeks 7-8||||0.6422
91749292|NCT01939002|183390905|SUPERIORITY_OR_OTHER|||||||0.2123|||||||paired t-test within 1 arm|||change at Week 4||||0.2123
91749293|NCT01939002|183390905|SUPERIORITY_OR_OTHER|||||||0.5834|||||||paired t-test within 1 arm|||change at Week 12||||0.5834
91749294|NCT01939002|183390905|SUPERIORITY_OR_OTHER|||||||0.8723|||||||paired t-test within 1 arm|||change at Week 24||||0.8723
91749295|NCT01939002|183390905|SUPERIORITY_OR_OTHER|||||||0.4173|||||||paired t-test within 1 arm|||change at Week 36||||0.4173
91749296|NCT01939002|183390905|SUPERIORITY_OR_OTHER|||||||0.2267|||||||paired t-test within 1 arm|||change at Week 48||||0.2267
91749297|NCT01939002|183390905|SUPERIORITY_OR_OTHER|||||||0.0171|||||||paired t-test within 1 arm|||change at Early Term||||0.0171
91749298|NCT01939002|183390906|SUPERIORITY_OR_OTHER|||||||0.0001|||||||paired t-test within 1 arm|||change at Week 4||||0.0001
91749299|NCT01939002|183390906|SUPERIORITY_OR_OTHER|||||||0.0007|||||||paired t-test within 1 arm|||change at Week 12||||0.0007
91749300|NCT01939002|183390906|SUPERIORITY_OR_OTHER|||||||0.0365|||||||paired t-test within 1 arm|||change at Week 24||||0.0365
91749301|NCT01939002|183390906|SUPERIORITY_OR_OTHER|||||||0.0197|||||||paired t-test within 1 arm|||change at Week 36||||0.0197
91749302|NCT01939002|183390906|SUPERIORITY_OR_OTHER|||||||0.4031|||||||paired t-test within 1 arm|||change at Week 48||||0.4031
91749303|NCT01939002|183390906|SUPERIORITY_OR_OTHER|||||||0.006|||||||paired t-test within 1 arm|||change at Early Termination||||0.0060
91749304|NCT01939002|183390907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
91749305|NCT01939002|183390907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
91749306|NCT01939002|183390907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
91749307|NCT01939002|183390907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
91749308|NCT01939002|183390907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
91749309|NCT01939002|183390907|SUPERIORITY_OR_OTHER|||||||0.1789|||||||paired t-test within 1 arm|||change at Early Termination||||0.1789
91749310|NCT01939002|183390907|SUPERIORITY_OR_OTHER|||||||0.2248||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.2248
91749311|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
91749312|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
91749313|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
91749314|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
91749315|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
91749316|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Early Termination||||<0.0001
91504864|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-7.8|STANDARD_ERROR_OF_MEAN|2.22||0.0004|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
91504865|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-7.0|STANDARD_ERROR_OF_MEAN|3.58||0.0511|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0511
91749317|NCT01939002|183390908|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||<0.0001
91749318|NCT01939002|183390909|SUPERIORITY_OR_OTHER|||||||0.7012|||||||paired t-test within 1 arm|||change at Week 4||||0.7012
91749319|NCT01939002|183390909|SUPERIORITY_OR_OTHER|||||||0.0548|||||||paired t-test within 1 arm|||change at Week 4||||0.0548
91749320|NCT01939002|183390909|SUPERIORITY_OR_OTHER|||||||0.0782|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0782
91749321|NCT01939002|183390910|SUPERIORITY_OR_OTHER|||||||0.0006|||||||paired t-test within 1 arm|||change at Week 4||||0.0006
91749322|NCT01939002|183390910|SUPERIORITY_OR_OTHER|||||||0.0792|||||||paired t-test within 1 arm|||change at Week 4||||0.0792
91749323|NCT01939002|183390910|SUPERIORITY_OR_OTHER|||||||0.0961|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0961
91749324|NCT01939002|183390911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
91749325|NCT01939002|183390911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
91749326|NCT01939002|183390911|SUPERIORITY_OR_OTHER|||||||0.4973|||||||2-sample t-test between 2 arms|||change at Week 4||||0.4973
91749327|NCT01939002|183390912|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
91749328|NCT01939002|183390912|SUPERIORITY_OR_OTHER|||||||0.0464|||||||paired t-test within 1 arm|||change at Week 4||||0.0464
91749329|NCT01939002|183390912|SUPERIORITY_OR_OTHER|||||||0.1905|||||||2-sample t-test between 2 arms|||change at Week 4||||0.1905
91749330|NCT01939002|183390913|SUPERIORITY_OR_OTHER|||||||0.6569|||||||paired t-test within 1 arm|||change at Week 12||||0.6569
91749331|NCT01939002|183390913|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 24||||0.1584
91749332|NCT01939002|183390913|SUPERIORITY_OR_OTHER|||||||0.5106|||||||paired t-test within 1 arm|||change at Week 36||||0.5106
91749333|NCT01939002|183390913|SUPERIORITY_OR_OTHER|||||||0.5927|||||||paired t-test within 1 arm|||change at Week 48||||0.5927
91749334|NCT01939002|183390913|SUPERIORITY_OR_OTHER|||||||0.384|||||||paired t-test within 1 arm|||change at Early Termination||||0.3840
91749335|NCT01939002|183390913|SUPERIORITY_OR_OTHER|||||||0.4182||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.4182
91749336|NCT01939002|183390914|SUPERIORITY_OR_OTHER|||||||0.2588|||||||paired t-test within 1 arm|||change at Week 12||||0.2588
91749337|NCT01939002|183390914|SUPERIORITY_OR_OTHER|||||||0.1092|||||||paired t-test within 1 arm|||change at Week 24||||0.1092
91749338|NCT01939002|183390914|SUPERIORITY_OR_OTHER|||||||1|||||||paired t-test within 1 arm|||change at Week 36||||1.0000
91749339|NCT01939002|183390914|SUPERIORITY_OR_OTHER|||||||0.219|||||||paired t-test within 1 arm|||change at Week 48||||0.2190
91749340|NCT01939002|183390914|SUPERIORITY_OR_OTHER|||||||0.6402||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.6402
91749341|NCT01939002|183390915|SUPERIORITY_OR_OTHER|||||||0.4821|||||||paired t-test within 1 arm|||change at Week 12||||0.4821
91749342|NCT01939002|183390915|SUPERIORITY_OR_OTHER|||||||0.5298|||||||paired t-test within 1 arm|||change at Week 24||||0.5298
91749343|NCT01939002|183390915|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 36||||0.1584
91749344|NCT01939002|183390915|SUPERIORITY_OR_OTHER|||||||0.2547|||||||paired t-test within 1 arm|||change at Week 48||||0.2547
91749345|NCT01939002|183390915|SUPERIORITY_OR_OTHER|||||||0.0824|||||||paired t-test within 1 arm|||change at Early Termination||||0.0824
91749346|NCT01939002|183390915|SUPERIORITY_OR_OTHER|||||||0.3148||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.3148
91749347|NCT01939002|183390916|SUPERIORITY_OR_OTHER|||||||0.6508|||||||paired t-test within 1 arm|||change at Week 12||||0.6508
91749348|NCT01939002|183390916|SUPERIORITY_OR_OTHER|||||||0.0315|||||||paired t-test within 1 arm|||change at Week 48||||0.0315
91749349|NCT01939002|183390916|SUPERIORITY_OR_OTHER|||||||0.119|||||||paired t-test within 1 arm|||change at Early Termination||||0.1190
91749350|NCT01939002|183390916|SUPERIORITY_OR_OTHER|||||||0.152||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.1520
91749351|NCT01939002|183390918|SUPERIORITY_OR_OTHER|||||||0.0049|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0049
91749352|NCT01939002|183390918|SUPERIORITY_OR_OTHER|||||||0.223|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.2230
91749353|NCT01939002|183390918|SUPERIORITY_OR_OTHER|||||||0.0031|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0031
91749354|NCT01939002|183390918|SUPERIORITY_OR_OTHER|||||||0.1624|||||||2-sample t-test between 2 arms|||Change from 4WRI to L4W||||0.1624
91504866|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504867|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.8703|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8703
91749355|NCT00098748|183390930|NON_INFERIORITY_OR_EQUIVALENCE|For hypothesis of superiority, if upper bound of 97.5% confidence interval (CI) of TX difference was \<0 log10 copies/mL, it was concluded that MVC regimen was superior to PBO meaning that MVC added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone. If superiority could not be concluded, then a hypothesis of noninferiority was tested. If upper bound of CI is \<0.25 log10 copies/mL, noninferiority of MVC regimen to placebo was claimed.|Least squares mean|0.055|STANDARD_ERROR_OF_MEAN|0.2575|||TWO_SIDED|97.5|-0.528|0.638|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC versus (vs) PBO=advantage of MVC.|Maraviroc (MVC) QD versus placebo (PBO) treatment (TX) difference at Week 24. If upper bound of 97.5% confidence interval is \<0, it is concluded that dose is superior to PBO. If upper bound is \<0.25, it is concluded that MVC is non-inferior to PBO. Assumption: 79% of subjects are dual-tropic; total N=192 needed to be randomized to get N=150 dual-tropic. Standard deviation=0.8 with 2-sided p-value=0.025: 80% power for TX difference of 0.5 for change from baseline in log10-transformed viral load.||0.638|-0.528|
91749356|NCT00098748|183390930|SUPERIORITY_OR_OTHER||Least squares mean|-0.232|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|97.5|-0.829|0.364|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||0.364|-0.829|
91749357|NCT00098748|183390930|SUPERIORITY_OR_OTHER||Least squares mean|0.229|STANDARD_ERROR_OF_MEAN|0.2567|||TWO_SIDED|97.5|-0.351|0.81|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||0.810|-0.351|
91749358|NCT00098748|183390930|SUPERIORITY_OR_OTHER||Least squares mean|-0.261|STANDARD_ERROR_OF_MEAN|0.2628|||TWO_SIDED|97.5|-0.856|0.333|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||0.333|-0.856|
91504868|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504869|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.9049|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9049
91504870|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-7.6|STANDARD_ERROR_OF_MEAN|2.44||0.0019|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0019
91531923|NCT01815736|182939921|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.04|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|All Participants||-0.02|-0.05|<0.001
91531924|NCT01815736|182939922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||NDA Data Cut||||<0.001
91749359|NCT00098748|183390931|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.12|0.18|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.18|-0.12|
91749360|NCT00098748|183390931|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.08|0.23|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.23|-0.08|
91749361|NCT00098748|183390931|SUPERIORITY_OR_OTHER||difference in proportions|0.02|||||TWO_SIDED|95.0|-0.12|0.17|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.17|-0.12|
91749362|NCT00098748|183390931|SUPERIORITY_OR_OTHER||difference in proportions|0.09|||||TWO_SIDED|95.0|-0.07|0.25|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.25|-0.07|
91749363|NCT00098748|183390932|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.15|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.15|
91749364|NCT00098748|183390932|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
91749365|NCT00098748|183390932|SUPERIORITY_OR_OTHER||difference in proportions|-0.06|||||TWO_SIDED|95.0|-0.22|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.22|
91749366|NCT00098748|183390932|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.07|0.28|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.28|-0.07|
91749367|NCT00098748|183390933|SUPERIORITY_OR_OTHER||difference in proportions|-0.05|||||TWO_SIDED|95.0|-0.21|0.12|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.12|-0.21|
91749368|NCT00098748|183390933|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
91749369|NCT00098748|183390933|SUPERIORITY_OR_OTHER||difference in proportions|-0.02|||||TWO_SIDED|95.0|-0.18|0.13|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.13|-0.18|
91504871|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-12.3|STANDARD_ERROR_OF_MEAN|4.15||0.0033|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
91749370|NCT00098748|183390933|SUPERIORITY_OR_OTHER||difference in proportions|0.12|||||TWO_SIDED|95.0|-0.04|0.29|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.29|-0.04|
91749371|NCT00098748|183390934|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.07|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.07|
91749372|NCT00098748|183390934|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.03|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO difference in proportions at Week 24.||0.26|-0.03|
91749373|NCT00098748|183390934|SUPERIORITY_OR_OTHER||difference in proportions|-0.04|||||TWO_SIDED|95.0|-0.18|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.18|
91749374|NCT00098748|183390934|SUPERIORITY_OR_OTHER||difference in proportions|0.06|||||TWO_SIDED|95.0|-0.1|0.21|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.21|-0.10|
91749375|NCT00098748|183390935|SUPERIORITY_OR_OTHER||Least squares mean|23.927|STANDARD_ERROR_OF_MEAN|12.8025|||TWO_SIDED|95.0|-1.359|49.213|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||49.213|-1.359|
91749376|NCT00098748|183390935|SUPERIORITY_OR_OTHER||Least squares mean|26.679|STANDARD_ERROR_OF_MEAN|13.0678|||TWO_SIDED|95.0|0.869|52.49|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||52.490|0.869|
91749377|NCT00098748|183390935|SUPERIORITY_OR_OTHER||Least squares mean|14.61|STANDARD_ERROR_OF_MEAN|16.412|||TWO_SIDED|95.0|-17.8|47.03|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||47.03|-17.80|
91531925|NCT01815736|182939922|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||All Participants||||<0.001
91749378|NCT00098748|183390935|SUPERIORITY_OR_OTHER||Least squares mean|27.71|STANDARD_ERROR_OF_MEAN|16.754|||TWO_SIDED|95.0|-5.38|60.8|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||60.80|-5.38|
91749379|NCT00098748|183390936|SUPERIORITY_OR_OTHER||Least squares mean|234.499|STANDARD_ERROR_OF_MEAN|80.799|||TWO_SIDED|95.0|74.913|394.084|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||394.084|74.913|
91749380|NCT00098748|183390936|SUPERIORITY_OR_OTHER||Least squares mean|188.817|STANDARD_ERROR_OF_MEAN|83.4484|||TWO_SIDED|95.0|23.999|353.635|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||353.635|23.999|
91749381|NCT00098748|183390936|SUPERIORITY_OR_OTHER||Least squares mean|155.94|STANDARD_ERROR_OF_MEAN|87.304|||TWO_SIDED|95.0|-16.49|328.37|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||328.37|-16.49|
91749382|NCT00098748|183390936|SUPERIORITY_OR_OTHER||Least squares mean|182.91|STANDARD_ERROR_OF_MEAN|90.174|||TWO_SIDED|95.0|4.81|361.02|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||361.02|4.81|
91749383|NCT00098748|183390937|SUPERIORITY_OR_OTHER|||||||0.7524||95.0|||||Log Rank|||MVC QD vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.7524
91749384|NCT00098748|183390937|SUPERIORITY_OR_OTHER|||||||0.254||95.0|||||Log Rank|||MVC BID vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.2540
91749385|NCT00098748|183390937|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||Log Rank|||MVC QD vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.8243
91749386|NCT00098748|183390937|SUPERIORITY_OR_OTHER|||||||0.6657||95.0|||||Log Rank|||MVC BID vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.6657
91749387|NCT00098748|183390938|SUPERIORITY_OR_OTHER||Least squares mean|0.069|STANDARD_ERROR_OF_MEAN|0.2356|||TWO_SIDED|95.0|-0.396|0.535|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 24.||0.535|-0.396|
91749388|NCT00098748|183390938|SUPERIORITY_OR_OTHER||Least squares mean|-0.218|STANDARD_ERROR_OF_MEAN|0.2413|||TWO_SIDED|95.0|-0.694|0.258|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 24.||0.258|-0.694|
91749389|NCT00098748|183390938|SUPERIORITY_OR_OTHER||Least squares mean|0.209|STANDARD_ERROR_OF_MEAN|0.2388|||TWO_SIDED|95.0|-0.262|0.681|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 48.||0.681|-0.262|
91749390|NCT00098748|183390938|SUPERIORITY_OR_OTHER||Least squares mean|-0.284|STANDARD_ERROR_OF_MEAN|0.2445|||TWO_SIDED|95.0|-0.767|0.199|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 48.||0.199|-0.767|
91749391|NCT03095027|183390946|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0||0.01||||||||0.01||
91749392|NCT00132691|183390980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.03||0.16|TWO_SIDED|95.0|-1.16|6.68||unadjusted|Generalized estimating equations, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|"Null hypothesis: There will be no difference in change in visual acuity between treatment groups.~Assuming 67% bilateral disease, between eye correlation of 0.4, SD of 16 letters' change over 2 years and two-sided type 1 error rate of .05, a sample size of 250 provided 91% power (assuming 10% crossover) to detect a treatment difference of 7.5 standard ETDRS letters' change in visual acuity from baseline to 24 months."||6.68|-1.16|0.16
91504872|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504873|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.4087|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4087
91504874|NCT01480076|182880004|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504875|NCT01480076|182880004|SUPERIORITY_OR_OTHER|||||||0.2755|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2755
91504876|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-5.7|STANDARD_ERROR_OF_MEAN|2.52||0.0251|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0251
91504877|NCT01480076|182880004|SUPERIORITY_OR_OTHER||difference of LS means|-6.7|STANDARD_ERROR_OF_MEAN|4.08||0.0989|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0989
91504878|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749393|NCT00132691|183390981|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.61||||0.071|TWO_SIDED|95.0|0.34|1.03||unadjusted|GEE, logistic||For each treatment group the odds of macular edema at 2 yrs as compared to baseline was computed. The treatment effect is the ratio of these odds (implant divided by systemic).|||1.03|0.34|0.071
91749394|NCT00132691|183390982|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.29||||0.001|TWO_SIDED|95.0|0.13|0.6||unadjusted|GEE, logistic||For each treatment group the odds of uveitis activity at 2 years as compared to baseline was computed. The treatment effect represents the ratio of these odds (implant divided by systemic).|||.60|.13|0.001
91749395|NCT00132691|183390983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.15||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 30 mmHg or greater. The systemic arm was the reference group.|||11.15|3.32|<.0001
91749396|NCT00132691|183390984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.34|5.5||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 24 mmHg or greater. The systemic arm was the reference group|||5.50|2.34|<.0001
91749397|NCT00132691|183390985|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.78|6.58||unadjusted|Cox proportional hazards with RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP that was 10mmHg or greater than the baseline value. The systemic arm was the reference group.|||6.58|2.78|<.0001
91504879|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.8767|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8767
91504880|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504881|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.3673|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3673
91749398|NCT00132691|183390986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.19||||0.0008|TWO_SIDED|95.0|1.82|9.63||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing glaucoma. The systemic arm was the reference group.|||9.63|1.82|0.0008
91504882|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-6.8|STANDARD_ERROR_OF_MEAN|1.91||0.0004|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
91749399|NCT00132691|183390987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.16|||<|0.0001|TWO_SIDED|95.0|2.67|6.47||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of using an IOP-lowering therapy. The systemic arm was the reference group.|||6.47|2.67|<.0001
91749400|NCT00132691|183390988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|8.4|||<|0.0001|TWO_SIDED|95.0|3.39|20.82||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of having surgery to lower IOP. The systemic arm was the reference group.|||20.82|3.39|<0.0001
91749401|NCT00132691|183390989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.21|7.67||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing a cataract. The systemic arm was the reference group.|||7.67|2.21|<0.0001
91504883|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.12||0.0273|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0273
91504884|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504885|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.9091|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9091
91504886|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504887|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.7718|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7718
91504888|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|2.11|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504889|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-10.1|STANDARD_ERROR_OF_MEAN|3.5||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
91504890|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504891|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.272|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2720
91504892|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91535624|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0278|TWO_SIDED|95.0|0.02|0.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.27|0.02|0.0278
91749402|NCT00132691|183390990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.64|STANDARD_ERROR_OF_MEAN|2.3||0.043|TWO_SIDED|95.0|0.14|9.15||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||9.15|0.14|0.043
91749403|NCT00132691|183390991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62|STANDARD_ERROR_OF_MEAN|1.6||0.023|TWO_SIDED|95.0|0.49|6.76||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic)|||6.76|0.49|0.023
91749404|NCT00132691|183390992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.95|STANDARD_ERROR_OF_MEAN|1.23||0.016|TWO_SIDED|95.0|0.54|5.36||unadjusted|Generalized Estimating Equations||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||5.36|0.54|0.016
91749405|NCT00132691|183390993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.84|TWO_SIDED|95.0|0.39|2.15||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hyperlipidemia for the implant and systemic treatments. The systemic treatment is the reference group.|||2.15|0.39|0.84
91749406|NCT00132691|183390994|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.13|TWO_SIDED|95.0|0.13|1.29||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hypertension for the implant and systemic treatments. The systemic treatment is the reference group.|||1.29|0.13|0.13
91504893|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.4767|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4767
91504894|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-4.5|STANDARD_ERROR_OF_MEAN|2.32||0.0553|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0553
91749407|NCT00132691|183390995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.24|TWO_SIDED|95.0|0.03|2.44||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of diabetes mellitus for the implant and systemic treatments. The systemic treatment is the reference group.|||2.44|0.03|0.24
91749408|NCT00798317|183390997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.13|||<|0.001|TWO_SIDED|95.0|1.97|17.0||Comparing placebo and ocriplasmin|Fisher Exact|||||17.00|1.97|<0.001
91504895|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.73||0.0632|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0632
91504896|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749409|NCT03344549|183391028|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.37|TWO_SIDED|95.0||||The threshoid for statistical significance was p \<0.05|t-test, 2 sided|||U Mann Whitney was used for inter-group comparison||||0.37
91749410|NCT03344549|183391029|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|U Mann Whitney was used for inter-group comparison||||||0.46
91749411|NCT03344549|183391030|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
91749412|NCT01679600|183391031|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||F1-LD-F1 model by Brunner and Langer|||||||0.53
91749413|NCT00108303|183391032|SUPERIORITY_OR_OTHER||Log (odd ratio)|5.2|||||TWO_SIDED|||||||||||||
91504897|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.9398|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9398
91504898|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504899|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.5655|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5655
91504900|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.54||0.0204|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0204
91504901|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|4.37||0.1414|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1414
91504902|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531926|NCT01815736|182939923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.7||||0.017|TWO_SIDED|95.0|0.4|7.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||7.0|0.4|0.017
91749414|NCT00108303|183391032|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||This parameter was estimated by simulating 1000 samples with random genotypes and finding no value equal to or greater than 5.2.|Simulation|||||||<0.001
91749415|NCT00108303|183391033|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Firsher's transform r to Z|||The coefficient of segregation versus no segregation of the P50 sensory gating percent in families with schizophrenia.||||0.001
91749416|NCT01685801|183391035|SUPERIORITY_OR_OTHER||Posterior Mean|2.251|STANDARD_DEVIATION|0.961|||TWO_SIDED|95.0|0.383|4.144|||||The posterior distribution of overall treatment difference was obtained using the Bayesian hierarchical model and 95% credible interval of the treatment effect (posterior mean) was calculated.|"This statistical analysis is for Overall category."||4.144|0.383|
91504903|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.6279|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6279
91749417|NCT01437098|183391068|SUPERIORITY_OR_OTHER||Proportion of IF Implanted Subjects|91.7|||<|0.001|TWO_SIDED|95.0|77.5|98.2|||Exact binomial|||||98.2|77.5|<0.001
91504904|NCT01480076|182880005|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749418|NCT00823212|183391126|NON_INFERIORITY_OR_EQUIVALENCE|A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value \<0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.|Difference in percent of participants|0.5||||0.001|ONE_SIDED|95.0||2.13|||Farrington-Manning test||The standard error for the difference was estimated according to the Farrington-Manning test.|Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.||2.13||0.001
91749419|NCT00834990|183391165|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.41||||||90.0|97.13|110.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110.08|97.13|
91504905|NCT01480076|182880005|SUPERIORITY_OR_OTHER|||||||0.2239|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2239
91504906|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-7.5|STANDARD_ERROR_OF_MEAN|2.67||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
91504907|NCT01480076|182880005|SUPERIORITY_OR_OTHER||difference of LS means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3457|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3457
91504908|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504909|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.2087|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2087
91504910|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504911|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.4487|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4487
91504912|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-2.1|STANDARD_ERROR_OF_MEAN|0.64||0.0013|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0013
91504913|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.15||0.0188|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0188
91504914|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749420|NCT00834990|183391166|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|101.68||||||90.0|96.79|106.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.83|96.79|
91504915|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.4243|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4243
91504916|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749421|NCT00834990|183391167|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.17||||||90.0|98.5|108.05|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.05|98.5|
91749422|NCT00791479|183391170|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
91504917|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.9989|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9989
91504918|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-1.6|STANDARD_ERROR_OF_MEAN|0.68||0.0207|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0207
91531927|NCT01815736|182939924|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|1.8||||0.29|TWO_SIDED|95.0|-1.7|5.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.3|-1.7|0.29
91531928|NCT01815736|182939924|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.2||||0.031|TWO_SIDED|95.0|0.1|6.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|All Participants||6.3|0.1|0.031
91749423|NCT00791479|183391170|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
91749424|NCT00791479|183391170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.069||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.069
91749425|NCT00791479|183391170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749426|NCT00791479|183391170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749427|NCT00791479|183391170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749428|NCT00791479|183391171|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
91749429|NCT00791479|183391171|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.023
91749430|NCT00791479|183391171|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
91749431|NCT00791479|183391171|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
91749432|NCT00791479|183391172|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
91749433|NCT00791479|183391172|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
91749434|NCT00791479|183391172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.81||||0.456||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.456
91749435|NCT00791479|183391172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.53|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749436|NCT00791479|183391172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.96|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749437|NCT00791479|183391172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.71|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749438|NCT00791479|183391173|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
91749439|NCT00791479|183391173|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
91749440|NCT00791479|183391174|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
91749441|NCT00791479|183391174|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
91504919|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-2.9|STANDARD_ERROR_OF_MEAN|1.18||0.0161|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0161
91504920|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504921|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.4256|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4256
91504922|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504923|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.3313|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3313
91504924|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|0.83||0.0238|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0238
91504925|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.015|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0150
91504926|NCT01480076|182880006|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504927|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.0171|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0171
91504928|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
91504929|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.5146|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5146
91504930|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
91504931|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.1224|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1224
91504932|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.0168|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0168
91504933|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.2272|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2272
91504934|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.057|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0570
91749442|NCT00791479|183391174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.65||||0.378||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.378
91749443|NCT00791479|183391174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.09|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749444|NCT00791479|183391174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.34|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749445|NCT00791479|183391174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.67|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
91749446|NCT00791479|183391175|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
91749447|NCT00791479|183391175|SUPERIORITY_OR_OTHER|||||||0.036||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.036
91749448|NCT00791479|183391176|SUPERIORITY_OR_OTHER|||||||0.45||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.450
91749449|NCT00791479|183391176|SUPERIORITY_OR_OTHER|||||||0.329||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.329
91749450|NCT00791479|183391184|SUPERIORITY_OR_OTHER|||||||0.969||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.969
91749451|NCT00791479|183391184|SUPERIORITY_OR_OTHER|||||||0.009||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.009
91749452|NCT00791479|183391184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.14||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.140
91749453|NCT00791479|183391184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.247||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.247
91749454|NCT00791479|183391184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.975||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.975
91749455|NCT00791479|183391184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||1.00
91749456|NCT01774097|183391223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.238|TWO_SIDED|95.0|-0.6|2.5||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.5|-0.6|0.238
91749457|NCT01774097|183391224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.116|TWO_SIDED|95.0|-0.2|2.1||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.1|-0.2|0.116
91749458|NCT01774097|183391225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.978|TWO_SIDED|95.0|-0.8|0.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.8|-0.8|0.978
91749459|NCT01774097|183391226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.752|TWO_SIDED|95.0|-1.26|0.91||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.91|-1.26|0.752
91749460|NCT01774097|183391227|SUPERIORITY_OR_OTHER||interaction term|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.871|TWO_SIDED|95.0|-0.02|0.03||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.03|-0.02|0.871
91749461|NCT01774097|183391228|SUPERIORITY_OR_OTHER||interaction term|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.256|TWO_SIDED|95.0|-0.06|0.02||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.02|-0.06|0.256
91749462|NCT01774097|183391229|SUPERIORITY_OR_OTHER||interaction term|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.241|TWO_SIDED|95.0|-0.2|0.6|||Regression, Linear|||||0.6|-0.2|0.241
91749463|NCT01774097|183391231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.131|TWO_SIDED|95.0|-0.6|4.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.8|-0.6|0.131
91504935|NCT01480076|182880006|SUPERIORITY_OR_OTHER|||||||0.5832|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5832
91504936|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|0.94||0.0561|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0561
91749464|NCT01774097|183391232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.7||0.626|TWO_SIDED|95.0|-2.6|4.2||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.2|-2.6|0.626
91749465|NCT01774097|183391233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.591|TWO_SIDED|95.0|-4.1|2.3||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||2.3|-4.1|0.591
91749466|NCT01774097|183391234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.0||0.722|TWO_SIDED|95.0|-3.3|4.7||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.7|-3.3|0.722
91749467|NCT03061721|183391270|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
91749468|NCT03061721|183391270|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
91749469|NCT03061721|183391270|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91749470|NCT03061721|183391271|SUPERIORITY|||||||0.5681|||||||ANCOVA|||||||0.5681
91749471|NCT03061721|183391271|SUPERIORITY|||||||0.4487|||||||ANCOVA|||||||0.4487
91749472|NCT03061721|183391271|SUPERIORITY|||||||0.0021|||||||ANCOVA|||||||0.0021
91749473|NCT03061721|183391272|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.0070
91749474|NCT03061721|183391272|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
91749475|NCT03061721|183391272|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
91749476|NCT03061721|183391273|SUPERIORITY|||||||0.2241|||||||ANCOVA|||||||0.2241
91749477|NCT03061721|183391273|SUPERIORITY|||||||0.0304|||||||ANCOVA|||||||0.0304
91749478|NCT03061721|183391273|SUPERIORITY|||||||0.0595|||||||ANCOVA|||||||0.0595
91749479|NCT03061721|183391274|SUPERIORITY|||||||0.0449|||||||ANCOVA|||||||0.0449
91749480|NCT03061721|183391274|SUPERIORITY|||||||0.0053|||||||ANCOVA|||||||0.0053
91749481|NCT03061721|183391274|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
91749482|NCT03061721|183391275|SUPERIORITY|||||||0.0045|||||||ANCOVA|||||||0.0045
91749483|NCT03061721|183391275|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
91749484|NCT03061721|183391275|SUPERIORITY|||||||0.0004|||||||ANCOVA|||||||0.0004
91749485|NCT03061721|183391284|SUPERIORITY|||||||0.2387|||||||ANCOVA|||||||0.2387
91749486|NCT03061721|183391284|SUPERIORITY|||||||0.1496|||||||ANCOVA|||||||0.1496
91749487|NCT03061721|183391284|SUPERIORITY|||||||0.0445|||||||ANCOVA|||||||0.0445
91749488|NCT01920568|183391343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.192|||ANCOVA||Primary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (breast cancer, yes or no) and log transformed BL value as covariates.|||-0.192|-0.440|<0.0001
91749489|NCT01920568|183391344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.188|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, ie log\[(Wk 13 uNTx/Cr)/(BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (Chinese participants, yes or no) and log transformed BL value|||-0.188|-0.444|<0.0001
91749490|NCT01920568|183391345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|||<|0.0001|TWO_SIDED|95.0|-0.539|-0.193|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect, stratification factor (Breast cancer, yes or no) and log transformed BL value as covariates.|||-0.193|-0.539|<0.0001
91749491|NCT04049266|183391359|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4 ETDRS letters, i.e. the non-inferiority margin (NI) is 4 letters.|Adjusted mean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.01|>|0.9999|TWO_SIDED|95.03|-8.0|-4.0|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, categories for baseline BCVA, BCVA-low luminance VA baseline, geographical location.||||-4|-8|> 0.9999
91749492|NCT01703208|183391367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.77|1.29|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.29|0.77|
91749493|NCT01703208|183391368|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||||TWO_SIDED|95.0|-0.48|-0.37||||||||-0.37|-0.48|
91749494|NCT01703208|183391369|SUPERIORITY_OR_OTHER||Difference in the LS Means vs Placebo|-0.39|||<|0.001|TWO_SIDED|95.0|-0.5|-0.27|||Longitudinal data analysis|Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.||||-0.27|-0.50|<0.001
91749495|NCT01703208|183391370|SUPERIORITY_OR_OTHER||Difference in Percent vs. Placebo|-1.1|||||TWO_SIDED|95.0|-7.2|4.9|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||4.9|-7.2|
91749496|NCT01703208|183391371|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Placebo|0.3|||||TWO_SIDED|95.0|-1.0|1.7|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||1.7|-1.0|
91749497|NCT01703208|183391373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.66|1.68|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.68|0.66|
91504937|NCT01480076|182880006|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|1.86||0.2971|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2971
91504938|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504939|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.0029|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0029
91504940|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504941|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.8041|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8041
91749498|NCT01703208|183391375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.6|1.26|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.26|0.60|
91749499|NCT01703208|183391377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.58|1.52|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.52|0.58|
91749500|NCT01703208|183391379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.88|1.85|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.85|0.88|
91749501|NCT01703208|183391380|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.3|||||TWO_SIDED|95.0|-0.46|-0.14|||||Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.|||-0.14|-0.46|
91749502|NCT01703208|183391386|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.1||||0.421|TWO_SIDED|95.0|-10.8|4.5|||Longitudinal constrained data analysis||Based on a LDA model including terms for treatment, time and the interaction of time by treatment.|||4.5|-10.8|0.421
91749503|NCT01703208|183391387|SUPERIORITY_OR_OTHER||Between group rate difference|11.9|||<|0.001|TWO_SIDED|95.0|6.9|16.8||Estimated using standard multiple imputation techniques.|Miettinen & Nurminen method|||||16.8|6.9|<0.001
91749504|NCT01703208|183391389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.35|1.05|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.05|0.35|
91749505|NCT01639339|183391404|OTHER||Odds Ratio (OR)|1.55||||0.0311|TWO_SIDED|95.0|1.04|2.32||P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.32|1.04|0.0311
91749506|NCT01639339|183391405|OTHER||Odds Ratio (OR)|1.74||||0.0167|TWO_SIDED|95.0|1.11|2.74||P-value was calculated using logistic regression model. Test 2 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.74|1.11|0.0167
91749507|NCT01639339|183391406|OTHER||Odds Ratio (OR)|1.59||||0.0245|TWO_SIDED|95.0|1.06|2.38||P-value was calculated using logistic regression model. Test 3 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.38|1.06|0.0245
91749508|NCT01639339|183391407|OTHER||Cox Proportional Hazard|0.51||||0.0014|TWO_SIDED|95.0|0.34|0.77||P-value was calculated using Cox proportional hazards model. Test 4 of 5 in a step-down sequential testing procedure.|Cox proportional hazards model||Treatment comparison between Belimumab 10 mg/kg and placebo using Cox proportional hazards ratio and its corresponding 95% confidence interval has been presented.|||0.77|0.34|0.0014
91749509|NCT01639339|183391408|OTHER|||||||0.0096||||||P-value is rank analysis of covariance model comparing Belimumab and Placebo with covariates for treatment group, induction regimen(CYC vs MMF),race(Black vs Non-black), Baseline uPCR, and eGFR. Test 5 of 5 in step-down sequential testing procedure.|Rank ANCOVA|||||||0.0096
91749510|NCT01271712|183391426|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.||||<0.000001
91749511|NCT01271712|183391426|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.268|||||TWO_SIDED|95.0|0.185|0.388|||Regression, Cox|stratified|regorafenib over placebo|Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model||0.388|0.185|
91749512|NCT01271712|183391427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285777|||||||Log Rank|stratified||||||0.285777
91749513|NCT01271712|183391427|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.909|||||TWO_SIDED|95.0|0.653|1.265|||Regression, Cox|stratified|regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.|Hazard ratio and its 95% CI was based on stratified Cox Regression Model||1.265|0.653|
91749514|NCT01271712|183391428|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||||||<0.000001
91749515|NCT01271712|183391428|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.248|||||TWO_SIDED|95.0|0.17|0.364|||Regression, Cox|stratified||||0.364|0.170|
91749516|NCT01431014|183391433|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
91749517|NCT02685748|183391434|OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.444||0.863|TWO_SIDED|95.0|-0.969|0.815|||t-test, 2 sided|||||0.815|-0.969|0.863
91749518|NCT02685748|183391435|OTHER|T test for independent samples|Mean Difference (Final Values)|3.616|STANDARD_ERROR_OF_MEAN|2.364||0.133|TWO_SIDED|95.0|-1.147|8.379|||t-test, 2 sided|||||8.379|-1.147|0.133
91749519|NCT02685748|183391436|OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.43||1.607|TWO_SIDED|95.0|-1.1553|0.172|||t-test, 2 sided|||||0.172|-1.1553|1.607
91749520|NCT02685748|183391437|OTHER||Mean Difference (Final Values)|-1.282|STANDARD_ERROR_OF_MEAN|1.754||0.468|TWO_SIDED|95.0|-4.807|2.241|||t-test, 2 sided|||||2.241|-4.807|0.468
91749521|NCT02685748|183391438|OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.406||0.899|TWO_SIDED|95.0|-0.869|0.765|||t-test, 2 sided|||||0.765|-0.869|0.899
91749522|NCT02685748|183391439|OTHER||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|6.797||0.305|TWO_SIDED|95.0|-6.602|20.703|||t-test, 2 sided|||||20.703|-6.602|0.305
91504942|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|11.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504943|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|9.4|STANDARD_ERROR_OF_MEAN|3.1||0.0026|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
91504944|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504945|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.0689|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0689
91749523|NCT02685748|183391440|OTHER||Mean Difference (Final Values)|160.298|STANDARD_ERROR_OF_MEAN|159.525||0.32|TWO_SIDED|95.0|-160.118|480.714|||t-test, 2 sided|||||480.714|-160.118|0.320
91749524|NCT02685748|183391441|OTHER||Mean Difference (Final Values)|-1.495|STANDARD_ERROR_OF_MEAN|3.558||0.676|TWO_SIDED|95.0|-8.642|5.651|||t-test, 2 sided|||||5.651|-8.642|0.676
91749525|NCT01846299|183391549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78|STANDARD_ERROR_OF_MEAN|1.203||0.0111|TWO_SIDED|95.0|0.4|5.16|||Mixed Models Analysis|||||5.16|0.40|0.0111
91749526|NCT01960998|183391581|SUPERIORITY|||||||0.22||||||P value not adjusted for multiple comparisons|Log Rank||||Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.|||0.22
91749527|NCT01960998|183391582|SUPERIORITY|||||||0.7||||||P values were not corrected for multiple testing|ANCOVA|Baseline score was included as a covariate in analysis.|||Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.|||0.70
91749528|NCT01960998|183391583|SUPERIORITY|||||||0.7||||||P values were not adjusted for multiple comparisons.|ANCOVA||||Mean values for the telehealth and no telehealth groups on the EPIC-UI are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPIC-UI score in the no telehealth group at 6 months was 63.5 (standard deviation 24.1) and in the telehealth group was 63.9 (SD 22.1). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline EPIC-UI score, and p values were combined using the Rubin-Licht method.|||0.70
91749529|NCT01960998|183391584|SUPERIORITY|||||||0.46||||||P values not adjusted for multiple comparisons.|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the IIQ are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean IIQ score in the no telehealth group at 6 months was 22.3 (standard deviation 24.1) and in the telehealth group was 19.4 (SD 22.4). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.46
91749530|NCT01960998|183391585|SUPERIORITY|||||||0.63||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Quality of Life question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 31.4% (Delighted/Pleased), 22.8% (Mostly Satisfied), 19.4% (Mixed), 12.0% (Mostly Dissatisfied), and 14.4% (Unhappy/Terrible) and in the telehealth group were 20.8%, 26.3%, 26.3%, 12.6%, and 14.0%, respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the IPSS Quality of Life question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
91749531|NCT01960998|183391586|SUPERIORITY|||||||0.04||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Patient Satisfaction question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Completely Satisfied), 40.2% (Somewhat Satisfied), and 8.7% (Not at All Satisfied) and in the telehealth group were 34.8%, 59.9%, and 5.3%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Patient Satisfaction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.04
91504946|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504947|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.7182|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7182
91504948|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749532|NCT01960998|183391587|SUPERIORITY|||||||0.67||||||P values not adjusted for multiple comparisons|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the Estimated Percent Improvement (EPI) are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPI score in the no telehealth group at 6 months was 65.1 (standard deviation 34.5) and in the telehealth group was 69.6 (SD 29.6). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.67
91749533|NCT01960998|183391588|SUPERIORITY|||||||0.65|||||||Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Global Perception of Improvement (GPI) question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 46.3% (Much Better), 30.7% (Better), 16.7% (About the Same), 2.3% (Worse), and 3.9% (Much Worse) and in the telehealth group were 38.3%, 41.1%, 15.3%, 2.9%, and 2.5%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the Global Perception of Improvement question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.65
91749534|NCT01960998|183391589|SUPERIORITY|||||||0.37||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||"Frequencies for the telehealth and no telehealth groups on the How Disturbing is the Urine Leakage? question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 43.5% (Not at All), 44.4% (Somewhat), and 12.1% (Extremely) and in the telehealth group were 38.9%, 53.2%, and 7.9% respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the How Disturbing is the Urine Leakage? question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method."|||0.37
91749535|NCT01960998|183391590|SUPERIORITY|||||||0.63||||||P values were not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Activity Restriction question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Not at all), 36.5% (Some of the time), 7.2% (Most of the time), and 5.3% (All of the time) and in the telehealth group were 56.5%, 33.5%, 4.2%, and 5.8% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Activity Restriction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
91749536|NCT01960998|183391591|SUPERIORITY|||||||0.71||||||P values not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Return to Work question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 52.3% (Yes), 5.0% (No, not yet recovered from surgery), 1.9% (No, other reason), and 40.7% (Retired or disabled) and in the telehealth group were 62.3%, 3.5%, 0.8%, and 33.5% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Return to Work question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.71
91504949|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|9.8|STANDARD_ERROR_OF_MEAN|3.57||0.0061|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0061
91504950|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749537|NCT01960998|183391592|SUPERIORITY|||||||0.41||||||P values not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Resumption of Normal Activities question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 7.4% (None), 29.8% (Some), 62.8% (All) and in the telehealth group were 4.9%, 23.0%, and 72.2% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Resumption of Normal Activities question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.41
91749538|NCT01103063|183391635|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|STANDARD_DEVIATION|0.0647||0.12237|TWO_SIDED|95.0|0.97|1.25||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.25|0.97|0.12237
91749539|NCT01103063|183391636|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.1243||0.84117|TWO_SIDED|95.0|0.8|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.80|0.84117
91749540|NCT01103063|183391637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_DEVIATION|0.1745||0.4428|TWO_SIDED|95.0|0.62|1.23||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.23|0.62|0.4428
91749541|NCT01103063|183391638|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|STANDARD_DEVIATION|0.1882||0.6086|TWO_SIDED|95.0|0.63|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.63|0.6086
91749542|NCT01103063|183391639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2866||0.7035|TWO_SIDED|95.0|0.51|1.57||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.57|0.51|0.7035
91749543|NCT01103063|183391640|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.04||0.4605|TWO_SIDED|95.0|0.95|1.11||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.11|0.95|0.4605
91749544|NCT01103063|183391641|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|0.1817||0.7105|TWO_SIDED|95.0|0.65|1.33||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.33|0.65|0.7105
91749545|NCT01103063|183391642|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.1842||0.3468|TWO_SIDED|95.0|0.59|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.59|0.3468
91504951|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.0179|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0179
91504952|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504953|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.6911|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6911
91504954|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|2.31|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504955|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|7.1|STANDARD_ERROR_OF_MEAN|3.85||0.0666|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0666
91504956|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749546|NCT01103063|183391643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0011|TWO_SIDED|95.0|-0.08|-0.02||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.02|-0.08|0.0011
91749547|NCT01103063|183391644|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|STANDARD_DEVIATION|0.0604||0.2265|TWO_SIDED|95.0|0.96|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.96|0.2265
91749548|NCT01103063|183391645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0131|TWO_SIDED|95.0|-0.24|-0.03||Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable.|ANCOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.03|-0.24|0.0131
91749549|NCT01103063|183391646|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2694||0.6978|TWO_SIDED|95.0|0.53|1.53||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.53|0.53|0.6978
91749550|NCT01103063|183391647|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|STANDARD_DEVIATION|0.2908||0.6542|TWO_SIDED|95.0|0.64|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.64|0.6542
91749551|NCT01103063|183391648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|19.71||0.9145|TWO_SIDED|95.0|-36.5|40.8||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable.|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||40.8|-36.5|0.9145
91749552|NCT01103063|183391649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.04|-0.09|<0.0001
91504957|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.0158|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
91504958|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504959|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.6684|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6684
91504960|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504961|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|10.5|STANDARD_ERROR_OF_MEAN|4.28||0.0141|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
91504962|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504963|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.0042|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
91531929|NCT01815736|182939925|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|5.3||||0.003|TWO_SIDED|95.0|1.6|9.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||9.0|1.6|0.003
91504964|NCT01480076|182880007|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504965|NCT01480076|182880007|SUPERIORITY_OR_OTHER|||||||0.7329|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7329
91504966|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|13.2|STANDARD_ERROR_OF_MEAN|2.65|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91749553|NCT01103063|183391650|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|STANDARD_DEVIATION|0.1221|<|0.0001|TWO_SIDED|95.0|0.38|0.62||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.62|0.38|<0.0001
91504967|NCT01480076|182880007|SUPERIORITY_OR_OTHER||difference of LS means|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0242|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0242
91504968|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
91504969|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.9151|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9151
91504970|NCT01480076|182880008|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504971|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.6128|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6128
91504972|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0331|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0331
91504973|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1919|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1919
91504974|NCT01480076|182880008|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504975|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.4481|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4481
91504976|NCT01480076|182880008|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91504977|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.5454|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5454
91531930|NCT01815736|182939926|SUPERIORITY||Difference in least squares means|6.0||||0.56|TWO_SIDED|95.0|-14.0|26.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. FTC/TDF+3rd Agent) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|NDA Data Cut: Change at Week 48||26|-14|0.56
91749554|NCT01103063|183391651|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|STANDARD_DEVIATION|0.2295||0.036|TWO_SIDED|95.0|0.39|0.97||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.97|0.39|0.0360
91504978|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0516|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0516
91504979|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.09|STANDARD_ERROR_OF_MEAN|0.04||0.0175|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0175
91504980|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
91504981|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.9371|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9371
91749555|NCT01103063|183391652|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_DEVIATION|0.163||0.1975|TWO_SIDED|95.0|0.59|1.12||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.12|0.59|0.1975
91749556|NCT01103063|183391653|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|STANDARD_DEVIATION|0.5675||0.4655|TWO_SIDED|95.0|0.22|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.22|0.4655
91749557|NCT01103063|183391654|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|STANDARD_DEVIATION|0.0918||0.0016|TWO_SIDED|95.0|0.62|0.9||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.90|0.62|0.0016
91749558|NCT01103063|183391655|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.34|STANDARD_DEVIATION|0.5338||0.1113|TWO_SIDED|95.0|0.82|6.66||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||6.66|0.82|0.1113
91749559|NCT01103063|183391656|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.25|STANDARD_DEVIATION|0.6386||0.0284|TWO_SIDED|95.0|0.07|0.86||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.86|0.07|0.0284
91749560|NCT01103063|183391657|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.3291||0.0188|TWO_SIDED|95.0|0.24|0.88||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.88|0.24|0.0188
91504982|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
91504983|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.5475|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5475
91504984|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0699|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0699
91504985|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.587|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5870
91504986|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
91504987|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.9926|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9926
91504988|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
91504989|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.6368|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6368
91504990|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3358|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3358
91504991|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5089|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5089
91504992|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0141|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
91504993|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.428|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4280
91504994|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
91504995|NCT01480076|182880008|SUPERIORITY_OR_OTHER|||||||0.3827|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3827
91504996|NCT01480076|182880008|SUPERIORITY_OR_OTHER||difference of LS means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0748|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0748
91504997|NCT01480076|182880008|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5663|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5663
91504998|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.1544|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1544
91504999|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
91505000|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.3868|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3868
91505001|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.2214|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2214
91505002|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|8.9|STANDARD_ERROR_OF_MEAN|4.96||0.0743|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0743
91505003|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|-17.2|STANDARD_ERROR_OF_MEAN|12.22||0.1601|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1601
91505004|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.1251|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1251
91505005|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.1764|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1764
91505006|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.5528|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5528
91505007|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.108|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1080
91505008|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|6.27||0.4644|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4644
91505009|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|-30.6|STANDARD_ERROR_OF_MEAN|17.91||0.0887|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
91505010|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.0071|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0071
91505011|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.064|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0640
91505012|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.1552|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1552
91531931|NCT01815736|182939926|SUPERIORITY||Difference in least squares means|11.0||||0.26|TWO_SIDED|95.0|-8.0|29.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs.SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|All Participants: Change at Week 48||29|-8|0.26
91505013|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.5979|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5979
91505014|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|4.3|STANDARD_ERROR_OF_MEAN|5.58||0.4444|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4444
91505015|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|-10.7|STANDARD_ERROR_OF_MEAN|12.27||0.3863|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3863
91505016|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.6352|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6352
91505017|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.1265|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1265
91505018|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.6161|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6161
91505019|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.528|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5280
91505020|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|11.5|STANDARD_ERROR_OF_MEAN|8.51||0.1769|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1769
91505021|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|-16.0|STANDARD_ERROR_OF_MEAN|22.24||0.4743|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4743
91505022|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.6901|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6901
91505023|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
91505024|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.7707|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7707
91505025|NCT01480076|182880009|SUPERIORITY_OR_OTHER|||||||0.4989|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4989
91505026|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|15.2|STANDARD_ERROR_OF_MEAN|7.31||0.0387|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0387
91505027|NCT01480076|182880009|SUPERIORITY_OR_OTHER||difference of LS means|-11.7|STANDARD_ERROR_OF_MEAN|15.88||0.4635|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4635
91505028|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.1392|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1392
91505029|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.1448|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1448
91505030|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.0187|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0187
91505031|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.292|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2920
91531932|NCT01815736|182939927|SUPERIORITY||Difference in least squares means|18.0||||0.074|TWO_SIDED|95.0|-2.0|38.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|||38|-2|0.074
91531933|NCT04684914|182939994|SUPERIORITY|||||||0.3029|||||||Chi-squared|||||||0.3029
91531934|NCT04684914|182939994|SUPERIORITY|||||||0.4881|||||||Fisher Exact|||||||0.4881
91505032|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|4.2|STANDARD_ERROR_OF_MEAN|4.95||0.3968|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3968
91505033|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|10.95||0.642|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6420
91531935|NCT04684914|182939995|SUPERIORITY|||||||0.3029|||||||Chi-squared|||||||0.3029
91531936|NCT04684914|182939995|SUPERIORITY|||||||0.4881|||||||Fisher Exact|||||||0.4881
91531937|NCT04684914|182939996|SUPERIORITY|||||||0.4169|||||||Chi-squared|||||||0.4169
91531938|NCT04684914|182939996|SUPERIORITY|||||||0.5495|||||||Fisher Exact|||||||0.5495
91531939|NCT04471792|182940034|SUPERIORITY|||||||0.38||||||P=0.380 comparing creatine vs. placebo|ANOVA|Two-way ANOVA for pre vs. post values and for the difference between creatine vs. placebo||||||0.38
91531940|NCT04471792|182940035|SUPERIORITY|||||||0.883||||||p=0.883 when comparing effect of creatine to palcebo on rate/change in reperfusion slope|ANOVA|Two-way ANOVA, pre vs. post differences and creatine vs. placebo differences were examined||||||0.883
91531941|NCT04471792|182940035|SUPERIORITY|||||||0.883|||||||ANOVA|||||||0.883
91505034|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.01|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0100
91505035|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.8634|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8634
91505036|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.0134|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0134
91505037|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.8147|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8147
91505038|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|-5.1|STANDARD_ERROR_OF_MEAN|6.06||0.4035|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4035
91505039|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|-4.8|STANDARD_ERROR_OF_MEAN|14.25||0.7385|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7385
91505040|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.0139|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0139
91505041|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.5207|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5207
91505042|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.0091|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0091
91531942|NCT01866475|182940049|NON_INFERIORITY|This study is designed to test the hypothesis that the IO device has no greater than a 4 percent infection rate. Equivalently, we define success as having at least a 96 percent infection free 48-hour placement.|||||||||||||||||The historical data for the device suggests an infection rate of 0.6 percent per 48 hours or a success rate of 99.4 percent. The formal objective in the design is to reject the one-sided null hypothesis that the success rate is no higher than 96 percent. The analysis will use the exact binomial test and will tolerate a Type I Error rate of 0.05 or less. If we assume a 99.4 percent success rate, the study will have 84 percent power with a sample size of 117 to reject the null hypothesis. If the null hypothesis is rejected, we conclude that the infection rate is less than 4 percent.|||
91749561|NCT01103063|183391658|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|STANDARD_DEVIATION|0.1336||0.0527|TWO_SIDED|95.0|0.59|1.0||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.00|0.59|0.0527
91749562|NCT01103063|183391659|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.1536||0.0384|TWO_SIDED|95.0|0.54|0.98||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.98|0.54|0.0384
91749563|NCT01103063|183391660|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|STANDARD_DEVIATION|0.8648||0.3942|TWO_SIDED|95.0|0.38|11.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||11.38|0.38|0.3942
91749564|NCT01103063|183391661|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39|STANDARD_DEVIATION|0.4439||0.0332|TWO_SIDED|95.0|0.16|0.93||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.93|0.16|0.0332
91749565|NCT01103063|183391662|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61|STANDARD_DEVIATION|0.4195||0.2321|TWO_SIDED|95.0|0.27|1.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.38|0.27|0.2321
91749566|NCT01103063|183391663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.76||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
91749567|NCT01103063|183391663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
91749568|NCT01103063|183391664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
91749569|NCT01103063|183391664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
91749570|NCT03397134|183391714|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals||||||0.043||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||To evaluate the efficacy of 2 fixed doses (32 mg and 64 mg) of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the PANSS Marder negative symptoms factor score (NSFS) over 12 weeks of double-blind treatment. Approximation 501 eligible patients will be randomized in a 2:2:1:1 ratio at baseline to 1 of 4 treatment arms.||||0.043
91749571|NCT03397134|183391715|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals.||||||0.016||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||The PSP involves four subscale domains: (a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. After each of these four areas is scored on an anchored Likert-type scale (0-5), raters are instructed to select a 10-point range within a 100-point scale, guided by the area scores assigned during assessment.||||0.016
91749572|NCT00557310|183391739|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|||||||0.363
91749573|NCT00557310|183391740|SUPERIORITY_OR_OTHER|||||||0.837||95.0|||||Mixed Model Repeated Measurements|||||||0.837
91749574|NCT00557310|183391741|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measurements|||||||0.816
91749575|NCT00557310|183391741|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.934
91749576|NCT00557310|183391742|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measures|||||||0.324
91749577|NCT00557310|183391742|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measures|||||||0.089
91749578|NCT00557310|183391743|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.847
91505043|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.2312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2312
91531943|NCT02401529|182940057|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||||||0.033
91531944|NCT02401529|182940058|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
91531945|NCT02401529|182940059|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Chi-squared|||||||0.016
91531946|NCT02401529|182940060|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
91531947|NCT02401529|182940061|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||||||0.012
91531948|NCT02401529|182940062|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||0.024
91531949|NCT02401529|182940063|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
91531950|NCT02401529|182940064|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
91531951|NCT02401529|182940065|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
91531952|NCT02401529|182940066|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
91505044|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|5.89||0.7578|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7578
91505045|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|7.9|STANDARD_ERROR_OF_MEAN|13.42||0.5575|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5575
91505046|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.4486|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4486
91749579|NCT00557310|183391743|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.212
91749580|NCT00557310|183391744|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 3 months.||||||0.335
91531953|NCT05310084|182940108|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate-administration group) was greater than 0.67.|GMR|0.83|||||TWO_SIDED|95.0|0.77|0.89|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of concentrations (coadmin group-separate admin group), corresponding CIs based on analysis of log transformed assay results using a linear regression model.|||0.89|0.77|
91749581|NCT00557310|183391744|SUPERIORITY_OR_OTHER|||||||0.916||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.916
91749582|NCT00557310|183391744|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for the percent change from baseline at 12 months.|Mixed Model Repeated Measurements|||||||0.610
91749583|NCT00557310|183391744|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.363
91749584|NCT00557310|183391744|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.837
91749585|NCT00557310|183391745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91749586|NCT00557310|183391746|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||ANOVA|||||||0.021
91749587|NCT00557310|183391747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91749588|NCT00557310|183391748|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
91749589|NCT00557310|183391749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||<0.001
91505047|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
91505048|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.1185|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1185
91531954|NCT05310084|182940109|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.04|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Austria||1.04|0.77|
91749590|NCT00557310|183391749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||<0.001
91505049|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.7523|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7523
91531955|NCT05310084|182940109|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Phuket||1.13|0.89|
91531956|NCT05310084|182940109|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H1N1 A/Victoria||1.09|0.83|
91749591|NCT00557310|183391750|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.011
91749592|NCT00557310|183391750|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.049
91749593|NCT00557310|183391751|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.700
91749594|NCT00557310|183391751|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.092
91749595|NCT00557310|183391752|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.013
91749596|NCT00557310|183391752|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.005
91749597|NCT00557310|183391753|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.106
91749598|NCT00557310|183391753|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.436
91749599|NCT00557310|183391754|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||<0.001
91749600|NCT00557310|183391754|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||<0.001
91749601|NCT00557310|183391754|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||<0.001
91749602|NCT00557310|183391755|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||0.012
91749603|NCT00557310|183391755|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.012
91749604|NCT00557310|183391755|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.016
91749605|NCT02351349|183391759|OTHER|paired t test pre compared to post readings||||||0.0143|||||||t-test, 2 sided|||||||0.0143
91749606|NCT02351349|183391760|OTHER|as above||||||0.1416|||||||t-test, 2 sided|||pre and post comparison of time up and go in intervention group||||0.1416
91749607|NCT02351349|183391761|OTHER|||||||0.9013|||||||t-test, 2 sided|||pre and post value comparison with paired t test was carried out||||0.9013
91749608|NCT01509677|183391808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7922||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided test at 5% significant level||||0.7922
91749609|NCT01509677|183391808|SUPERIORITY||Risk Ratio (RR)|1.03|STANDARD_ERROR_OF_MEAN|0.12||0.7917|TWO_SIDED|95.0|0.82|1.3|||Poisson regression model|||||1.30|0.82|0.7917
91749610|NCT01509677|183391809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided, 5% test||||0.7145
91749611|NCT01509677|183391810|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.04|STANDARD_ERROR_OF_MEAN|0.119||0.7136|TWO_SIDED|95.0|0.83|1.3|||Poisson regression model|||2-sided 5% test||1.30|0.83|0.7136
91749612|NCT01509677|183391811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|15.45||0.4606||95.0|-19.2|42.1|||ANCOVA|||2-sided 5% test||42.1|-19.2|0.4606
91749613|NCT01509677|183391812|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19|STANDARD_ERROR_OF_MEAN|0.194||0.2744|TWO_SIDED|95.0|0.87|1.64|||Poisson regression model|||2-sided 5% test||1.64|0.87|0.2744
91749614|NCT01509677|183391813|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|STANDARD_ERROR_OF_MEAN|0.086||0.1128|TWO_SIDED|95.0|0.7|1.04|||Poisson regression model|||2-sided 5% test||1.04|0.70|0.1128
91749615|NCT01509677|183391814|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|STANDARD_ERROR_OF_MEAN|0.164||0.674|TWO_SIDED|95.0|0.66|1.31|||Regression, Linear|Poisson regression model||2-sided 5% test||1.31|0.66|0.6740
91749616|NCT01509677|183391815|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.84|STANDARD_ERROR_OF_MEAN|0.082||0.0677|TWO_SIDED|95.0|0.69|1.01|||Poisson regression model|||2-sided 5% test||1.01|0.69|0.0677
91749617|NCT01509677|183391816|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82|STANDARD_ERROR_OF_MEAN|0.177||0.3566|TWO_SIDED|95.0|0.54|1.25|||Poisson regression model|||2-sided 5% test||1.25|0.54|0.3566
91749618|NCT01509677|183391817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6354|STANDARD_ERROR_OF_MEAN|2.30185||0.4794|TWO_SIDED|95.0|-2.9429|6.2137|||ANCOVA|||2 sided 5% test||6.2137|-2.9429|0.4794
91749619|NCT01509677|183391818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4727|STANDARD_ERROR_OF_MEAN|0.32866||0.1541|TWO_SIDED|95.0|-0.181|1.1264|||ANCOVA|||2 sided 5% test||1.1264|-0.1810|0.1541
91749620|NCT01509677|183391819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0626|STANDARD_ERROR_OF_MEAN|0.03681||0.0927|TWO_SIDED|95.0|-0.1358|0.0106|||ANCOVA|||2 sided 5% test||0.0106|-0.1358|0.0927
91749621|NCT01509677|183391820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0107|STANDARD_ERROR_OF_MEAN|0.01647||0.5175|TWO_SIDED|95.0|-0.0435|0.022|||ANCOVA|||2 sided 5% test||0.0220|-0.0435|0.5175
91505050|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|17.1|STANDARD_ERROR_OF_MEAN|7.38||0.0214|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0214
91505051|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|0.4|STANDARD_ERROR_OF_MEAN|19.12||0.9826|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9826
91505052|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.6627|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6627
91505053|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.4674|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4674
91505054|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.2965|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2965
91749622|NCT01509677|183391821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.146|STANDARD_ERROR_OF_MEAN|3.3253||0.5205|TWO_SIDED|95.0|-4.466|8.757|||ANCOVA|||2-sided 5 % test||8.757|-4.466|0.5205
91505055|NCT01480076|182880010|SUPERIORITY_OR_OTHER|||||||0.1778|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1778
91505056|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|6.6|STANDARD_ERROR_OF_MEAN|7.65||0.3903|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3903
91505057|NCT01480076|182880010|SUPERIORITY_OR_OTHER||difference of LS means|16.8|STANDARD_ERROR_OF_MEAN|15.53||0.2794|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2794
91749623|NCT01509677|183391822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.141|STANDARD_ERROR_OF_MEAN|3.0057||0.7052|TWO_SIDED|95.0|-4.835|7.117|||ANCOVA|||2-sided 5 % test||7.117|-4.835|0.7052
91749624|NCT01509677|183391823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.867|STANDARD_ERROR_OF_MEAN|0.7331||0.0127|TWO_SIDED|95.0|-3.324|-0.409|||ANCOVA|||2-sided 5 % test||-0.409|-3.324|0.0127
91749625|NCT01509677|183391824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.1871||0.7862|TWO_SIDED|95.0|-0.423|0.321|||ANCOVA|||2-sided 5 % test||0.321|-0.423|0.7862
91505058|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
91749626|NCT01509677|183391825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.005||0.8769|TWO_SIDED|95.0|-1.84|2.15|||ANCOVA|||2-sided 5% test||2.15|-1.84|0.8769
91749627|NCT01509677|183391826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|711.1|STANDARD_ERROR_OF_MEAN|2768.79||0.7978|TWO_SIDED|95.0|-4778.3|6200.5|||ANCOVA|||2-sided 5% test||6200.5|-4778.3|0.7978
91749628|NCT01509677|183391827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|88.5|STANDARD_ERROR_OF_MEAN|79.26||0.2669|TWO_SIDED|95.0|-68.6|245.6|||ANCOVA|||2-sided 5% test||245.6|-68.6|0.2669
91749629|NCT01509677|183391828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.9|STANDARD_ERROR_OF_MEAN|67.78||0.7033|TWO_SIDED|95.0|-160.3|108.5|||ANCOVA|||2-sided 5% test||108.5|-160.3|0.7033
91749630|NCT01509677|183391829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.79|STANDARD_ERROR_OF_MEAN|18.039||0.1264|TWO_SIDED|95.0|-7.97|63.55|||ANCOVA|||2-sided 5% test||63.55|-7.97|0.1264
91749631|NCT01509677|183391830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|296.8|STANDARD_ERROR_OF_MEAN|124.07||0.0185|TWO_SIDED|95.0|50.9|542.7|||ANCOVA|||2-sided 5% test||542.7|50.9|0.0185
91505059|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.1166|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1166
91749632|NCT01509677|183391831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.086||0.9989|TWO_SIDED|95.0|-0.17|0.17|||ANCOVA|||2-sided 5% test||0.17|-0.17|0.9989
91749633|NCT01509677|183391832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.309||0.6701|TWO_SIDED|95.0|-3.15|2.03|||ANCOVA|||2-sided 5% test||2.03|-3.15|0.6701
91749634|NCT01509677|183391833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1105|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||2-sided 5% test||3.9|-0.4|0.1105
91749635|NCT01509677|183391834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|15.62||0.9261|TWO_SIDED|95.0|-32.4|29.5|||ANCOVA|||2-sided 5% test||29.5|-32.4|0.9261
91749636|NCT01509677|183391835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0257|TWO_SIDED|95.0|1.2|19.0|||ANCOVA|||2-sided 5% test||19.0|1.2|0.0257
91749637|NCT01509677|183391836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|18.11||0.0728|TWO_SIDED|95.0|-3.0|168.6|||ANCOVA|||2-sided 5% test||168.6|-3.0|0.0728
91749638|NCT01509677|183391837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.03||0.038|TWO_SIDED|95.0|0.004|0.122|||ANCOVA|||2-sided 5% test||0.122|0.004|0.0380
91749639|NCT01509677|183391838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.0552||0.2482|TWO_SIDED|95.0|-0.045|0.173|||ANCOVA|||2-sided 5% test||0.173|-0.045|0.2482
91749640|NCT01509677|183391839|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.0||||0.2629|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|Between treatment difference||2 sided 5 % test||1.00|-2.00|0.2629
91749641|NCT03549871|183391854|SUPERIORITY||ABR ratio|0.389|||=|0.0008|TWO_SIDED|95.0|0.224|0.675||The threshold for significance was \<0.05.|Repeated measures NB regression model|||Analyzed using repeated measures NB model with fixed effect of treatment period (fitusiran efficacy period or factor/BPA prophylaxis period) and robust sandwich covariance matrix was constructed to account for within participant dependence, logarithm of duration (in years) that each participant spends in each study period matching BE data being analyzed as an offset variable.||0.675|0.224|=0.0008
91749642|NCT03549871|183391856|SUPERIORITY||ABR ratio|0.444|||||TWO_SIDED|95.0|0.234|0.842||||||||0.842|0.234|
91749643|NCT03549871|183391858|SUPERIORITY||ABR ratio|0.485|||||TWO_SIDED|95.0|0.259|0.91||||||||0.910|0.259|
91749644|NCT01357161|183391873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.08|TWO_SIDED|80.0|0.45|0.89|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.89|0.45|0.080
91749645|NCT01357161|183391875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|80.0|0.39|0.79|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.79|0.39|0.030
91505060|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.0451|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0451
91749646|NCT01357161|183391877|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-2.9|11.4||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||11.4|-2.9|
91749647|NCT01357161|183391878|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-1.3|||||TWO_SIDED|95.0|-16.2|13.6||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||13.6|-16.2|
91749648|NCT01357161|183391879|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rat|5.2||||0.5247|TWO_SIDED|95.0|-10.9|21.1|||Miettinen and Nurminen's Method|||Stratified Miettinen and Nurminen's method with a two-sided p-Value for testing was used for comparison of the ORRs between the treatment groups in Part 2 portion of the study. A 95% confidence interval (CI) for the difference in response rates was provided.||21.1|-10.9|0.5247
91749649|NCT01357161|183391880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.8|TWO_SIDED|95.0|0.4|3.34|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||3.34|0.40|0.800
91749650|NCT00433160|183391886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.|t-test, 2 sided|||Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.||||<0.001
91505061|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.9327|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9327
91505062|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|6.28||0.4177|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4177
91505063|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|-7.9|STANDARD_ERROR_OF_MEAN|14.64||0.5885|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5885
91505064|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.0059|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0059
91505065|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.3467|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3467
91531957|NCT05310084|182940109|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.96|||||TWO_SIDED|95.0|0.85|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H3N2 A/Darwin||1.09|0.85|
91531958|NCT03531905|182940198|SUPERIORITY||Difference of Least Squares (LS) means|-39.6|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-45.8|-33.4|||ANCOVA|||||-33.4|-45.8|<0.001
91531959|NCT03531905|182940198|SUPERIORITY||Difference of LS means|-19.5|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-25.7|-13.4|||ANCOVA|||||-13.4|-25.7|<0.001
91749651|NCT00433160|183391890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.||||<0.001
91749652|NCT00433160|183391890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.||||<0.001
91505066|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
91505067|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.3965|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3965
91531960|NCT03531905|182940198|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
91531961|NCT03531905|182940199|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
91531962|NCT03531905|182940200|SUPERIORITY||Location shift|-36.7|STANDARD_ERROR_OF_MEAN|9.77|<|0.001|TWO_SIDED|95.0|-55.97|-17.67|||Wilcoxon rank sum test|||||-17.67|-55.97|<0.001
91531963|NCT03531905|182940200|SUPERIORITY||Location shift|-29.2|STANDARD_ERROR_OF_MEAN|10.03||0.005|TWO_SIDED|95.0|-48.92|-9.62|||Wilcoxon rank sum test|||||-9.62|-48.92|0.005
91531964|NCT03531905|182940200|SUPERIORITY||Location shift|-7.5|STANDARD_ERROR_OF_MEAN|11.29||0.48|TWO_SIDED|95.0|-30.51|13.76|||Wilcoxon rank sum test|||||13.76|-30.51|0.480
91531965|NCT03531905|182940201|SUPERIORITY||Difference of LS means|-33.1|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-38.6|-27.5|||ANCOVA|||||-27.5|-38.6|<0.001
91749653|NCT00433160|183391890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.||||<0.001
91505068|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|-1.3|STANDARD_ERROR_OF_MEAN|7.11||0.8548|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8548
91505069|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|-25.1|STANDARD_ERROR_OF_MEAN|21.35||0.2405|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2405
91749654|NCT00433160|183391890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.||||<0.001
91749655|NCT00433160|183391890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.||||<0.001
91749656|NCT00433160|183391891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.||||<0.001
91749657|NCT00433160|183391891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.||||<0.001
91749658|NCT00433160|183391891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.||||<0.001
91749659|NCT00433160|183391891|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wicoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.||||0.060
91749660|NCT00433160|183391891|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.||||0.130
91749661|NCT00433160|183391892|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.||||0.976
91749662|NCT00433160|183391892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.||||<0.001
91749663|NCT00433160|183391892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.||||<0.001
91749664|NCT00433160|183391892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.||||<0.001
91749665|NCT00433160|183391892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.||||<0.001
91749666|NCT02240368|183391906|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
91749667|NCT02240368|183391907|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
91749668|NCT02240368|183391908|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91749669|NCT02240368|183391909|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91749670|NCT02793817|183391918|SUPERIORITY||Difference in percentage of responders|8.3||||0.0105|TWO_SIDED|95.0|2.0|14.7||To account for multiplicity, a step-down testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared tests (unadjusted) wherein the a priori significance level was 0.05.||14.7|2.0|0.0105
91505070|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
91505071|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.8105|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8105
91505072|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.047|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0470
91505073|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.6067|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6067
91505074|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|-6.0|STANDARD_ERROR_OF_MEAN|7.56||0.4309|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4309
91505075|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|16.09||0.9761|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9761
91531966|NCT03531905|182940201|SUPERIORITY||Difference of LS means|-15.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-20.8|-9.7|||ANCOVA|||||-9.7|-20.8|<0.001
91531967|NCT03531905|182940201|SUPERIORITY||Difference of LS means|-17.8|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-23.3|-12.4|||ANCOVA|||||-12.4|-23.3|<0.001
91531968|NCT03531905|182940202|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-31.7|-22.8|||ANCOVA|||||-22.8|-31.7|<0.001
91531969|NCT03531905|182940202|SUPERIORITY||Difference of LS means|-13.4|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-17.8|-9.0|||ANCOVA|||||-9.0|-17.8|<0.001
91531970|NCT03531905|182940202|SUPERIORITY||Difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-18.2|-9.5|||ANCOVA|||||-9.5|-18.2|<0.001
91531971|NCT03531905|182940203|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-32.6|-21.8|||ANCOVA|||||-21.8|-32.6|<0.001
91531972|NCT03531905|182940203|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-18.1|-7.4|||ANCOVA|||||-7.4|-18.1|<0.001
91531973|NCT03531905|182940203|SUPERIORITY||Difference of LS means|-14.4|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-19.7|-9.1|||ANCOVA|||||-9.1|-19.7|<0.001
91749671|NCT02793817|183391919|SUPERIORITY||Difference in percentage of responders|20.0|||<|0.0001|TWO_SIDED|95.0|11.6|28.4||To account for multiplicity, a step-down closed testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared test (unadjusted), wherein a priori significance level was 0.05||28.4|11.6|<0.0001
91749672|NCT02793817|183391920|SUPERIORITY||Difference in percentage of responders|17.1|||<|0.0001|TWO_SIDED|95.0|9.1|25.0||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||25.0|9.1|<0.0001
91749673|NCT02793817|183391921|SUPERIORITY||Difference in percentage of responders|19.0|||<|0.0001|TWO_SIDED|95.0|11.0|26.9||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||26.9|11.0|<0.0001
91505076|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.6261|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6261
91749674|NCT02793817|183391922|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0078|TWO_SIDED|95.0|-0.31|-0.05|||Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for change from BL.|P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.||-0.05|-0.31|0.0078
91505077|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
91505078|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.2884|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2884
91749675|NCT02793817|183391923|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.0005|TWO_SIDED|95.0|-0.38|-0.11||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without any adjustment for covariates|Estimated Value is the between-group difference in change from BL|||-0.11|-0.38|0.0005
91749676|NCT02793817|183391924|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.0169|TWO_SIDED|95.0|-0.28|-0.03||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without adjustments for any covariates.|Estimated Value is the between-group difference for change from BL|||-0.03|-0.28|0.0169
91505079|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.8854|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8854
91505080|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|16.9|STANDARD_ERROR_OF_MEAN|10.88||0.1226|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1226
91505081|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|26.07||0.7249|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7249
91531974|NCT03531905|182940204|SUPERIORITY||Location shift|-3.9|STANDARD_ERROR_OF_MEAN|5.44||0.457|TWO_SIDED|95.0|-14.55|6.79|||Wilcoxon rank sum test|||||6.79|-14.55|0.457
91531975|NCT03531905|182940204|SUPERIORITY||Difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|5.25||0.351|TWO_SIDED|95.0|-4.93|15.63|||ANCOVA|||||15.63|-4.93|0.351
91531976|NCT03531905|182940204|SUPERIORITY||Difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|4.75||0.068|TWO_SIDED|95.0|-17.92|0.68|||ANCOVA|||||0.68|-17.92|0.068
91531977|NCT03531905|182940205|SUPERIORITY||Difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.14||0.007|TWO_SIDED|95.0|-10.1|-1.7|||ANCOVA|||||-1.7|-10.1|0.007
91505082|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.5129|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5129
91505083|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
91505084|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.1086|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1086
91505085|NCT01480076|182880011|SUPERIORITY_OR_OTHER|||||||0.5746|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5746
91505086|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|8.07||0.1831|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1831
91505087|NCT01480076|182880011|SUPERIORITY_OR_OTHER||difference of LS means|2.1|STANDARD_ERROR_OF_MEAN|15.54||0.8917|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8917
91531978|NCT03531905|182940205|SUPERIORITY||Difference of LS means|-7.3|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-11.5|-3.1|||ANCOVA|||||-3.1|-11.5|<0.001
91749677|NCT03995680|183391939|SUPERIORITY||Difference in Egg Reduction Rate (%)|2.3|||||TWO_SIDED|95.0|-7.8|12.6|||Regression, Logistic|Adjusted for age, sex, weight and baseline hookworm infection intensity (light or moderate/heavy)||The 95% confidence intervals (CIs) for ERRs and the difference between ERRs were estimated via bootstrap resampling. Superiority was claimed if the 95% confidence interval of the difference in ERRs did not include unity. Logistic regression models were used to assess efficacy in terms of CRs. In a subsequent analysis an adjusted logistic regression (adjustment for age, sex, weight and baseline infection intensity) was performed.||12.6|-7.8|
91749678|NCT00871117|183391940|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% confidence interval (CI) for the between-group differences in booster response to diphtheria was greater than or equal to (≥)-10%.|Difference in booster response rates|0.01|||||TWO_SIDED|95.0|-2.54|2.58||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of diphtheria (D) booster response one month after vaccination with DTaP-IPV vaccine.||2.58|-2.54|
91749679|NCT00871117|183391940|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to tetanus was ≥ -10%.|Difference in booster response rates|0.98|||||TWO_SIDED|95.0|-1.99|4.26||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of tetanus (T) booster response one month after vaccination with DTaP-IPV vaccine.||4.26|-1.99|
91505088|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505089|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.1152|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1152
91505090|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531979|NCT03531905|182940205|SUPERIORITY||Difference of LS means|1.4|STANDARD_ERROR_OF_MEAN|2.11||0.517|TWO_SIDED|95.0|-2.8|5.5|||ANCOVA|||||5.5|-2.8|0.517
91531980|NCT03531905|182940206|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91531981|NCT03531905|182940206|SUPERIORITY|||||||0.118|||||||Fisher Exact|||||||0.118
91531982|NCT03531905|182940206|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91531983|NCT03531905|182940207|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91531984|NCT03531905|182940207|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91531985|NCT03531905|182940209|SUPERIORITY||Difference of LS means|-0.3|STANDARD_ERROR_OF_MEAN|1.83||0.877|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||||3.3|-3.9|0.877
91505091|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.4578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4578
91505092|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|2.56||0.0125|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0125
91505093|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-10.2|STANDARD_ERROR_OF_MEAN|4.23||0.0158|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
91505094|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505095|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.2894|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2894
91531986|NCT03531905|182940209|SUPERIORITY||Difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.83||0.669|TWO_SIDED|95.0|-2.8|4.4|||ANCOVA|||||4.4|-2.8|0.669
91531987|NCT03531905|182940209|SUPERIORITY||Difference of LS means|-1.1|STANDARD_ERROR_OF_MEAN|1.81||0.556|TWO_SIDED|95.0|-4.6|2.5|||ANCOVA|||||2.5|-4.6|0.556
91749680|NCT00871117|183391941|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PT was ≥ -10%|Difference in booster response rates|-0.76|||||TWO_SIDED|95.0|-5.07|3.51||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertussis toxoid (PT) booster response one month after vaccination with DTaP-IPV vaccine.||3.51|-5.07|
91505096|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505097|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.723|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7230
91505098|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.2||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
91531988|NCT03531905|182940210|SUPERIORITY||Difference of LS means|2.5|STANDARD_ERROR_OF_MEAN|4.64||0.589|TWO_SIDED|95.0|-6.7|11.7|||ANCOVA|||||11.7|-6.7|0.589
91531989|NCT03531905|182940210|SUPERIORITY||Difference of LS means|0.6|STANDARD_ERROR_OF_MEAN|4.64||0.904|TWO_SIDED|95.0|-8.6|9.7|||ANCOVA|||||9.7|-8.6|0.904
91531990|NCT03531905|182940210|SUPERIORITY||Difference of LS means|2.0|STANDARD_ERROR_OF_MEAN|4.66||0.676|TWO_SIDED|95.0|-7.3|11.2|||ANCOVA|||||11.2|-7.3|0.676
91749681|NCT00871117|183391941|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to FHA was ≥ -10%.|Difference in booster response rates|-0.91|||||TWO_SIDED|95.0|-3.59|1.39||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of filamentous hemagglutinin (FHA) booster response one month after vaccination with DTaP-IPV vaccine.||1.39|-3.59|
91531991|NCT03531905|182940212|SUPERIORITY||Difference of LS means|-15.8|STANDARD_ERROR_OF_MEAN|13.95||0.258|TWO_SIDED|95.0|-43.4|11.7|||ANCOVA|||||11.7|-43.4|0.258
91531992|NCT03531905|182940212|SUPERIORITY||Difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|13.79||0.972|TWO_SIDED|95.0|-26.8|27.7|||ANCOVA|||||27.7|-26.8|0.972
91531993|NCT03531905|182940212|SUPERIORITY||Difference of LS means|-16.3|STANDARD_ERROR_OF_MEAN|13.68||0.235|TWO_SIDED|95.0|-43.3|10.7|||ANCOVA|||||10.7|-43.3|0.235
91531994|NCT05153174|182940233|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.931|||||||t-test, 2 sided|||||||0.931
91531995|NCT05153174|182940234|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.224|||||||t-test, 2 sided|||||||0.224
91531996|NCT01033643|182940238|OTHER||Accumulation or Geometric Mean Ratio|2.36|||||||||||||Accumulation ratio or geometric mean ratio (GMR) was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
91749682|NCT00871117|183391941|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PRN, was ≥ -10%.|Difference in booster response rates|1.42|||||TWO_SIDED|95.0|-0.32|4.08||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertactin (PRN) booster response one month after vaccination with DTaP-IPV vaccine.||4.08|-0.32|
91505099|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|5.37||0.0097|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
91505100|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505101|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
91505102|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91531997|NCT01033643|182940239|OTHER||Accumulation or Geometric Mean Ratio|1.62|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
91531998|NCT01033643|182940241|OTHER||Accumulation or Geometric Mean Ratio|1.9|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
91749683|NCT00871117|183391942|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios for poliovirus type 1 antigens was ≥ 0.67.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.76|1.1||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 1 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.1|0.76|
91749684|NCT00871117|183391942|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 2 antigens was ≥ 0.67.|Adjusted GMT ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 2 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||0.99|0.7|
91749685|NCT00871117|183391942|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 3 antigens was ≥ 0.67.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|1.01||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 3 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.01|0.71|
91749686|NCT03222973|183391960|SUPERIORITY||Treatment Difference|0.15||||0.1479|TWO_SIDED|95.0|-0.05|0.35||P-values are based on the Mixed Model for Repeated Measures (MMRM) adjusted for background DMT group, baseline magnetization transfer ratio (MTR)/diffusion tensor imaging (DTI) category and baseline component assessments.|MMRM|||Over 72 weeks: Overall Response Score||0.35|-0.05|0.1479
91749687|NCT03222973|183391962|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7682|TWO_SIDED|95.0|0.65|1.79||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.79|0.65|0.7682
91749688|NCT03222973|183391963|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2131|TWO_SIDED|95.0|0.41|1.22||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.22|0.41|0.2131
91749689|NCT03222973|183391964|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.47|1.41||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.41|0.47|0.4654
91749690|NCT03222973|183391965|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0417|TWO_SIDED|95.0|1.02|3.11||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||3.11|1.02|0.0417
91749691|NCT03222973|183391966|SUPERIORITY||Odds Ratio (OR)|1.35||||0.2908|TWO_SIDED|95.0|0.78|2.33||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||2.33|0.78|0.2908
91531999|NCT01033643|182940241|OTHER||Accumulation or Geometric Mean Ratio|1.63|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
91532000|NCT01033643|182940242|OTHER||Accumulation or Geometric Mean Ratio|1.91|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
91505103|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.9232|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9232
91505104|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-5.2|STANDARD_ERROR_OF_MEAN|3.37||0.1249|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1249
91532001|NCT01033643|182940243|OTHER||Accumulation or Geometric Mean Ratio|1.38|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
91532002|NCT01033643|182940250|OTHER|Linear Model|Mean Difference from Placebo|-4.17|||||TWO_SIDED|90.0|-9.53|1.2||||||||1.20|-9.53|
91532003|NCT01033643|182940250|OTHER|Linear Model|Mean Difference from Placebo|4.78|||||TWO_SIDED|90.0|-1.41|10.97||||||||10.97|-1.41|
91532004|NCT01033643|182940250|OTHER|Linear Model|Mean Difference from Placebo|-3.47|||||TWO_SIDED|90.0|-8.37|1.42||||||||1.42|-8.37|
91532005|NCT01033643|182940250|OTHER|Linear Model|Mean Difference from Placebo|3.53|||||TWO_SIDED|90.0|-1.37|8.42||||||||8.42|-1.37|
91532006|NCT01033643|182940251|OTHER|Linear Model|Mean Difference from Placebo|0.23|||||TWO_SIDED|90.0|-6.91|7.36||||||||7.36|-6.91|
91505105|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-14.1|STANDARD_ERROR_OF_MEAN|5.42||0.0093|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0093
91532007|NCT01033643|182940251|OTHER|Linear Model|Mean Difference from Placebo|-1.66|||||TWO_SIDED|90.0|-8.79|5.47||||||||5.47|-8.79|
91532008|NCT01033643|182940251|OTHER|Linear Model|Mean Difference from Placebo|2.11|||||TWO_SIDED|90.0|-5.02|9.25||||||||9.25|-5.02|
91532009|NCT01033643|182940251|OTHER|Linear Model|Mean Difference from Placebo|-1.23|||||TWO_SIDED|90.0|-9.41|6.94||||||||6.94|-9.41|
91532010|NCT01033643|182940252|OTHER|Linear Model|Mean Difference from Placebo|-0.75|||||TWO_SIDED|90.0|-9.29|7.79||||||||7.79|-9.29|
91532011|NCT01033643|182940252|OTHER|Linear Model|Mean Difference from Placebo|-3.73|||||TWO_SIDED|90.0|-14.32|6.86||||||||6.86|-14.32|
91532012|NCT01033643|182940252|OTHER|Linear Model|Mean Difference from Placebo|0.66|||||TWO_SIDED|90.0|-7.88|9.2||||||||9.20|-7.88|
91532013|NCT01033643|182940252|OTHER|Linear Model|Mean Difference from Placebo|-9.92|||||TWO_SIDED|90.0|-19.54|-0.3||||||||-0.30|-19.54|
91532014|NCT01033643|182940253|OTHER|Linear Model|Mean Difference from Placebo|-1.02|||||TWO_SIDED|90.0|-9.36|7.32||||||||7.32|-9.36|
91532015|NCT01033643|182940253|OTHER|Linear Model|Mean Difference from Placebo|-2.12|||||TWO_SIDED|90.0|-12.47|8.22||||||||8.22|-12.47|
91532016|NCT01033643|182940253|OTHER|Linear Model|Mean Difference from Placebo|-0.53|||||TWO_SIDED|90.0|-8.87|7.81||||||||7.81|-8.87|
91532017|NCT01033643|182940253|OTHER|Linear Model|Mean Difference from Placebo|-10.44|||||TWO_SIDED|90.0|-19.83|-1.04||||||||-1.04|-19.83|
91532018|NCT01033643|182940254|OTHER|Linear Model|Mean Difference from Placebo|-1.73|||||TWO_SIDED|90.0|-6.5|3.04||||||||3.04|-6.50|
91532019|NCT01033643|182940254|OTHER|Linear Model|Mean Difference from Placebo|-4.23|||||TWO_SIDED|90.0|-9.0|0.54||||||||0.54|-9.00|
91532020|NCT01033643|182940254|OTHER|Linear Model|Mean Difference from Placebo|-1.05|||||TWO_SIDED|90.0|-5.82|3.72||||||||3.72|-5.82|
91532021|NCT01033643|182940254|OTHER|Linear Model|Mean Difference from Placebo|-2.0|||||TWO_SIDED|90.0|-3.46|7.46||||||||7.46|-3.46|
91532022|NCT01033643|182940255|OTHER|Linear Model|Mean Difference from Placebo|-3.87|||||TWO_SIDED|90.0|-9.37|1.64||||||||1.64|-9.37|
91532023|NCT01033643|182940255|OTHER|Linear Model|Mean Difference from Placebo|-7.2|||||TWO_SIDED|90.0|-14.03|-0.37||||||||-0.37|-14.03|
91532024|NCT01033643|182940255|OTHER|Linear Model|Mean Difference from Placebo|-1.33|||||TWO_SIDED|90.0|-6.83|4.18||||||||4.18|-6.83|
91532025|NCT01033643|182940255|OTHER|Linear Model|Mean Difference from Placebo|-2.24|||||TWO_SIDED|90.0|-8.45|3.96||||||||3.96|-8.45|
91532026|NCT01033643|182940256|OTHER|Linear Model|Mean Difference from Placebo|-2.74|||||TWO_SIDED|90.0|-7.92|2.43||||||||2.43|-7.92|
91532027|NCT01033643|182940256|OTHER|Linear Model|Mean Difference from Placebo|-6.67|||||TWO_SIDED|90.0|-13.09|-0.25||||||||-0.25|-13.09|
91532028|NCT01033643|182940256|OTHER|Linear Model|Mean Difference from Placebo|-0.74|||||TWO_SIDED|90.0|-5.91|4.44||||||||4.44|-5.91|
91532029|NCT01033643|182940256|OTHER|Linear Model|Mean Difference from Placebo|-2.81|||||TWO_SIDED|90.0|-8.64|3.02||||||||3.02|-8.64|
91532030|NCT01033643|182940257|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.47|1.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.87|0.47|
91532031|NCT01033643|182940257|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|90.0|0.26|0.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||0.87|0.26|
91532032|NCT01033643|182940257|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.95|||||TWO_SIDED|90.0|0.51|1.79|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.79|0.51|
91532033|NCT03527277|182940261|SUPERIORITY||Mean Difference (Net)|-0.3||||0.88|TWO_SIDED|95.0|-4.0|3.5|||ANCOVA|Effect of group on change of outcome with adjustment for BMI, Outcome at baseline and gender||||3.5|-4.0|0.88
91749692|NCT02080481|183391978|SUPERIORITY_OR_OTHER||ratio of geometric means|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76|||Regression, Linear|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the linear regression model.||||0.76|0.61|< 0.001
91749693|NCT02080481|183391979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.56|TWO_SIDED|98.3|0.25|9.6|||Regression, Logistic|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the logistic regression model.|Odds ratio for Infiniti Plus versus conventional needle patients|||9.6|0.25|0.56
91749694|NCT02080481|183391980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13||||0.06|TWO_SIDED|98.3|0.01|1.78||Intraoperative management strategy was imbalanced between groups and adjusted for in the logistic regression model.|Regression, Logistic|||||1.78|0.01|0.06
91749695|NCT02080481|183391981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.74|TWO_SIDED|98.3|-7.7|14.6|||Regression, Linear|Intraoperative management strategy was imbalanced between randomized groups and adjusted for in the linear regression model.||||14.6|-7.7|0.74
91749696|NCT03998670|183391986|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.1|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The primary analysis was the treatment group difference (and 95% CI) in mean distance control at the 8-week outcome visit using an ANCOVA adjusted for baseline distance control. The planned convenience sample size of 64 was expected to provide outcome data for at least 60 participants (30 per group).||1.1|-0.5|
91749697|NCT03998670|183391987|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-17.0|32.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||32|-17|
91749698|NCT03998670|183391988|SUPERIORITY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-27.0|19.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||19|-27|
91749699|NCT03998670|183391990|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.7|0.7|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The secondary analysis was the treatment group difference (and 95% CI) in mean near control at the 8-week outcome visit using an ANCOVA adjusted for baseline near control.||0.7|-0.7|
91749700|NCT03730961|183392017|SUPERIORITY|Drug - placebo|Mean Difference (Net)|-448.0||||0.0021|TWO_SIDED|95.0|-714.0|-183.0|||t-test, 2 sided|||||-183|-714|0.0021
91749701|NCT03730961|183392017|SUPERIORITY|Percent change Drug - placebo|Mean Difference (Net)|-22.1||||0.0222|TWO_SIDED|95.0|-40.7|-3.51|||t-test, 2 sided|||||-3.51|-40.7|0.0222
91749702|NCT03730961|183392018|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-4.25||||0.0163|TWO_SIDED|95.0|-7.63|-0.876|||t-test, 2 sided|||||-0.876|-7.63|0.0163
91749703|NCT03730961|183392018|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-15.0||||0.2018|TWO_SIDED|95.0|-38.8|8.77|||t-test, 2 sided|||||8.77|-38.8|0.2018
91749704|NCT03730961|183392018|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-3.61||||0.0526|TWO_SIDED|95.0|-7.27|0.0446|||t-test, 2 sided|||||0.0446|-7.27|0.0526
91749705|NCT03730961|183392018|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-14.9||||0.2076|TWO_SIDED|95.0|-38.8|9.0|||t-test, 2 sided|||||9|-38.8|0.2076
91749706|NCT03730961|183392019|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|0.431||||0.1621|TWO_SIDED|95.0|-0.189|1.05|||t-test, 2 sided|||||1.05|-0.189|0.1621
91749707|NCT03730961|183392019|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|32.0||||0.0338|TWO_SIDED|95.0|2.72|61.3|||t-test, 2 sided|||||61.3|2.72|0.0338
91532034|NCT03527277|182940262|SUPERIORITY||Mean Difference (Net)|-0.7||||0.65|TWO_SIDED|95.0|-3.7|2.3|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome and BMI at baseline.||||2.3|-3.7|0.65
91749708|NCT03730961|183392019|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|0.766||||0.06|TWO_SIDED|95.0|-0.0353|1.57|||t-test, 2 sided|||||1.57|-0.0353|0.0600
91749709|NCT03730961|183392019|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|33.5||||0.028|TWO_SIDED|95.0|4.02|63.0|||t-test, 2 sided|||||63|4.02|0.0280
91749710|NCT03730961|183392022|SUPERIORITY||Difference between drug and placebo|-4.0|STANDARD_DEVIATION|4.74||||||||||||||||
91749711|NCT00901511|183392065|SUPERIORITY||Median Difference (Final Values)|12.0||||0.0078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the median time to rescue WLL in the GM-CSF Group minus the median the time to rescue WLL in the Control Group|||||0.0078
91749712|NCT00901511|183392066|SUPERIORITY||Risk Ratio (RR)|7.0||||0.0152|TWO_SIDED|95.0|1.6|39.9|||Fisher Exact||Calculated as risk ratio of rescue WLL in the Control Group compared to the risk ratio of rescue WLL in the GM-CSF Group|||39.9|1.60|0.0152
91749713|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|9.5|||<|0.0001|TWO_SIDED|95.0|5.7|13.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean PaO2 in the GM-CSF Group minus the between group difference in mean PaO2 in the Control Group|||13.3|5.7|<0.0001
91749714|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|6.16||0.0261|TWO_SIDED|95.0|2.04|28.16|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.16|2.04|0.0261
91749715|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|9.56|STANDARD_ERROR_OF_MEAN|6.36||0.1521|TWO_SIDED|95.0|3.92|23.03|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||23.03|3.92|0.1521
91505106|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505107|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.0937|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0937
91505108|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505109|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.7814|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7814
91532035|NCT03527277|182940263|SUPERIORITY||Mean Difference (Net)|-0.2||||0.92|TWO_SIDED|95.0|-3.7|3.4|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome and BMI at baseline.||||3.4|-3.7|0.92
91532036|NCT03527277|182940264|SUPERIORITY||Mean Difference (Net)|-0.4||||0.81|TWO_SIDED|95.0|-3.3|2.6|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||2.6|-3.3|0.81
91532037|NCT03527277|182940265|SUPERIORITY||Mean Difference (Net)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.49|||ANCOVA|Effect of group with adjustment for gender and BMI and outcome at baseline.||||-0.49|-1.34|<0.0001
91749716|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|18.04|STANDARD_ERROR_OF_MEAN|5.56||0.0051|TWO_SIDED|95.0|6.26|29.82|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||29.82|6.26|0.0051
91749717|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|20.26|STANDARD_ERROR_OF_MEAN|4.54||0.0004|TWO_SIDED|95.0|10.63|29.88|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||29.88|10.63|0.0004
91505110|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-3.9|STANDARD_ERROR_OF_MEAN|3.47||0.2561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2561
91532038|NCT03527277|182940266|SUPERIORITY||Mean Difference (Net)|-3.4|||<|0.0001|TWO_SIDED|95.0|-4.7|-2.1|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||-2.1|-4.7|<0.0001
91532039|NCT03527277|182940267|SUPERIORITY||Mean Difference (Net)|-0.21||||0.42|TWO_SIDED|95.0|-0.74|0.31|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||0.31|-0.74|0.42
91749718|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.89||0.0038|TWO_SIDED|95.0|7.43|32.4|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||32.40|7.43|0.0038
91532040|NCT03527277|182940268|SUPERIORITY||Mean Difference (Net)|0.27||||0.28|TWO_SIDED|95.0|-0.23|0.76|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||0.76|-0.23|0.28
91532041|NCT03527277|182940269|SUPERIORITY||Mean Difference (Net)|-9.1||||0.59|TWO_SIDED|95.0|-42.9|24.7|||ANCOVA|Effect of group on change of outcome with adjustment of gender and BMI and outcome at baseline.||||24.7|-42.9|0.59
91532042|NCT03527277|182940270|SUPERIORITY||Mean Difference (Net)|-0.07||||0.35|TWO_SIDED|95.0|-0.21|0.08|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome at baseline.||||0.08|-0.21|0.35
91532043|NCT03527277|182940271|SUPERIORITY||Mean Difference (Net)|-0.01||||0.97|TWO_SIDED|95.0|-0.61|0.59|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome and BMI at baseline.||||0.59|-0.61|0.97
91532044|NCT03527277|182940272|SUPERIORITY||Mean Difference (Net)|-13.9||||0.002|TWO_SIDED|95.0|-22.4|-5.4|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome and BMI at baseline.||Effect of group on change of outcome with adjustment for BMI, outcome at baseline and gender.||-5.4|-22.4|0.002
91532045|NCT03527277|182940273|SUPERIORITY||Mean Difference (Net)|-7.9||||0.11|TWO_SIDED|95.0|-17.6|1.8|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||1.8|-17.6|0.11
91532046|NCT03527277|182940274|SUPERIORITY||Mean Difference (Net)|23340.0||||0.0032|TWO_SIDED|95.0|8284.0|38396.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||38396|8284|0.0032
91749719|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|6.15||0.0149|TWO_SIDED|95.0|3.81|30.03|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||30.03|3.81|0.0149
91749720|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|19.02|STANDARD_ERROR_OF_MEAN|6.97||0.0148|TWO_SIDED|95.0|4.26|33.79|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||33.79|4.26|0.0148
91749721|NCT00901511|183392067|SUPERIORITY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|6.62||0.1158|TWO_SIDED|95.0|-3.02|25.02|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|25.02|-3.02|0.1158
91749722|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.8|-5.4|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of A-aDO2 in the GM-CSF Group minus the mean value of A-aDO2 in the Control Group|Primary analysis||-5.4|-14.8|<0.0001
91749723|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-12.46|STANDARD_ERROR_OF_MEAN|6.0||0.0545|TWO_SIDED|95.0|-25.19|0.27|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.27|-25.19|0.0545
91749724|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-7.08|STANDARD_ERROR_OF_MEAN|6.34||0.2802|TWO_SIDED|95.0|-20.52|6.35|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||6.35|-20.52|0.2802
91505111|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-13.6|STANDARD_ERROR_OF_MEAN|6.07||0.0255|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0255
91505112|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505113|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.7241|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7241
91505114|NCT01480076|182880012|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
91505115|NCT01480076|182880012|SUPERIORITY_OR_OTHER|||||||0.0427|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0427
91749725|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
91749726|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-18.77|STANDARD_ERROR_OF_MEAN|4.91||0.0015|TWO_SIDED|95.0|-29.18|-8.36|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 3 -month visit after imputation of missing data using a last observation carried forward method.||-8.36|-29.18|0.0015
91749727|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-19.09|STANDARD_ERROR_OF_MEAN|5.85||0.0049|TWO_SIDED|95.0|-31.49|-6.7|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-6.70|-31.49|0.0049
91532047|NCT03527277|182940275|SUPERIORITY||Mean Difference (Net)|5558.0||||0.0003|TWO_SIDED|95.0|2680.0|8437.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||8437|2680|0.0003
91505116|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|-7.2|STANDARD_ERROR_OF_MEAN|3.67||0.0498|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0498
91749728|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-15.85|STANDARD_ERROR_OF_MEAN|5.84||0.0152|TWO_SIDED|95.0|-28.23|-3.48|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-3.48|-28.23|0.0152
91749729|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-17.01|STANDARD_ERROR_OF_MEAN|6.27||0.0154|TWO_SIDED|95.0|-30.31|-3.71|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||-3.71|-30.31|0.0154
91749730|NCT00901511|183392068|SUPERIORITY||Mean Difference (Final Values)|-11.01|STANDARD_ERROR_OF_MEAN|6.15||0.0921|TWO_SIDED|95.0|-24.05|2.02|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.02|-24.05|0.0921
91749731|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.022|TWO_SIDED|95.0|1.9|21.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of the DLCO in the GM-CSF Group minus the mean value of the DLCO in the Control Group|Primary Analysis||21.3|1.9|0.0220
91749732|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|8.29|STANDARD_ERROR_OF_MEAN|7.96||0.3186|TWO_SIDED|95.0|-9.06|25.63|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||25.63|-9.06|0.3186
91749733|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|5.56|STANDARD_ERROR_OF_MEAN|6.58||0.4111|TWO_SIDED|95.0|-8.4|19.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||19.51|-8.40|0.4111
91749734|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|12.89|STANDARD_ERROR_OF_MEAN|6.53||0.0658|TWO_SIDED|95.0|-0.95|26.73|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||26.73|-0.95|0.0658
91532048|NCT03527277|182940276|SUPERIORITY||Mean Difference (Net)|3824.0||||0.0012|TWO_SIDED|95.0|1611.0|6036.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline||||6036|1611|0.0012
91532049|NCT03527277|182940277|SUPERIORITY||Mean Difference (Net)|19522.0||||0.0023|TWO_SIDED|95.0|7353.0|31691.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||31691|7353|0.0023
91532050|NCT03527277|182940278|SUPERIORITY||Mean Difference (Net)|21881.0||||0.0001|TWO_SIDED|95.0|11307.0|32455.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||32455|11307|0.0001
91749735|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|9.78|STANDARD_ERROR_OF_MEAN|7.81||0.2287|TWO_SIDED|95.0|-6.78|26.34|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||26.34|-6.78|0.2287
91749736|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|8.37||0.1432|TWO_SIDED|95.0|-4.86|30.64|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||30.64|-4.86|0.1432
91532051|NCT03527277|182940279|SUPERIORITY||Mean Difference (Net)|9666.0||||0.0002|TWO_SIDED|95.0|4808.0|14524.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||14524|4808|0.0002
91532052|NCT03527277|182940280|SUPERIORITY||Mean Difference (Net)|3413.0||||0.0011|TWO_SIDED|95.0|1456.0|5370.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5370|1456|0.0011
91532053|NCT03527277|182940281|SUPERIORITY||Mean Difference (Net)|11.5||||0.59|TWO_SIDED|95.0|-32.0|55.1|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||55.1|-32.0|0.59
91532054|NCT03527277|182940282|SUPERIORITY||Mean Difference (Net)|74.6||||0.046|TWO_SIDED|95.0|1.3|147.9|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||147.9|1.3|0.046
91749737|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|11.78|STANDARD_ERROR_OF_MEAN|8.47||0.1833|TWO_SIDED|95.0|-6.17|29.73|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||29.73|-6.17|0.1833
91749738|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|12.67|STANDARD_ERROR_OF_MEAN|9.23||0.1888|TWO_SIDED|95.0|-6.9|32.23|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.23|-6.90|0.1888
91749739|NCT00901511|183392069|SUPERIORITY||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|8.79||0.6374|TWO_SIDED|95.0|-14.41|22.85|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||22.85|-14.41|0.6374
91749740|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.532|TWO_SIDED|95.0|-5.3|9.9|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|Primary Analysis||9.90|-5.30|0.5320
91749741|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|7.55||0.6772|TWO_SIDED|95.0|-13.09|19.52|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||19.52|-13.09|0.6772
91749742|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|6.7||0.832|TWO_SIDED|95.0|-12.52|15.64|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||15.64|-12.52|0.8320
91749743|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|7.82||0.8532|TWO_SIDED|95.0|-15.19|18.14|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||18.14|-15.19|0.8532
91749744|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|7.66||0.7752|TWO_SIDED|95.0|-14.0|18.44|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||18.44|-14.00|0.7752
91505117|NCT01480076|182880012|SUPERIORITY_OR_OTHER||difference of LS means|0.7|STANDARD_ERROR_OF_MEAN|5.95||0.9078|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9078
91505118|NCT02120950|182880031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.7||||0.548|TWO_SIDED|95.0|-2.9|1.6|||ANCOVA|||||1.6|-2.9|0.5480
91749745|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|5.74|STANDARD_ERROR_OF_MEAN|8.65||0.5174|TWO_SIDED|95.0|-12.7|24.18|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||24.18|-12.70|0.5174
91505119|NCT02120950|182880032|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7402|TWO_SIDED|95.0|-3.1|4.3|||Cochran-Mantel-Haenszel|||||4.3|-3.1|0.7402
91505120|NCT02120950|182880034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.0682|TWO_SIDED|95.0|0.0|0.2|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.2|0.0|0.0682
91749746|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|3.67|STANDARD_ERROR_OF_MEAN|7.68||0.6393|TWO_SIDED|95.0|-12.61|19.94|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||19.94|-12.61|0.6393
91749747|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|5.22|STANDARD_ERROR_OF_MEAN|8.26||0.5361|TWO_SIDED|95.0|-12.28|22.73|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||22.73|-12.28|0.5361
91749748|NCT00901511|183392070|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|7.04||0.8159|TWO_SIDED|95.0|-13.26|16.6|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean VC between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|16.60|-13.26|0.8159
91749749|NCT00901511|183392071|SUPERIORITY||Mean Difference (Final Values)|-0.822||||0.053|TWO_SIDED|95.0|-1.7|0.01|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the median value of the GGO Score in the GM-CSF Group minus the median value of the GGO Score in the Control Group|Primary Analysis||0.01|-1.70|0.0530
91749750|NCT00901511|183392071|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||>0.9999
91749751|NCT00901511|183392071|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0332|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0332
91749752|NCT00901511|183392071|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0676|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0676
91749753|NCT00901511|183392071|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0629|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0629
91749754|NCT00901511|183392071|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
91749755|NCT00901511|183392072|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.001|TWO_SIDED|95.0|-0.71|-0.22|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the CEA levels in the GM-CSF Group minus the CEA levels in the Control Group|Primary Analysis||-0.22|-0.71|0.0010
91749756|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-12.0||||0.0059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0059
91749757|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-3.45||||0.0382|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0382
91749758|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.0770
91749759|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-4.0||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0400
91749760|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-7.9||||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.0142
91749761|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-6.5||||0.0071|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0071
91749762|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-5.6||||0.0137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0137
91505121|NCT02120950|182880035|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.164|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.3|-0.1|0.1640
91505122|NCT02120950|182880038|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-5.6||||0.2348|TWO_SIDED|95.0|-14.9|3.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 5||3.7|-14.9|0.2348
91505123|NCT02120950|182880038|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-2.2||||0.6877|TWO_SIDED|95.0|-13.1|8.6|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 10||8.6|-13.1|0.6877
91505124|NCT02120950|182880038|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-4.0||||0.4556|TWO_SIDED|95.0|-14.5|6.5|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 15||6.5|-14.5|0.4556
91532055|NCT03527277|182940283|SUPERIORITY||Mean Difference (Net)|0.3||||0.56|TWO_SIDED|95.0|-0.7|1.3|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome and BMI at baseline.||Effect of group on change in outcome with adjustment for BMI, Outcome at baseline and gender.||1.3|-0.7|0.56
91505125|NCT02120950|182880039|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|1.7||||0.5372|TWO_SIDED|95.0|-3.7|7.2|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 5||7.2|-3.7|0.5372
91505126|NCT02120950|182880039|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7569|TWO_SIDED|95.0|-3.4|4.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 10||4.7|-3.4|0.7569
91505127|NCT02120950|182880039|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-0.6||||0.7402|TWO_SIDED|95.0|-4.3|3.1|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 15||3.1|-4.3|0.7402
91505128|NCT02120950|182880040|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-6.0||||0.3244|TWO_SIDED|95.0|-17.8|5.9|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|||5.9|-17.8|0.3244
91532056|NCT03527277|182940284|SUPERIORITY||Mean Difference (Net)|-0.8||||0.17|TWO_SIDED|95.0|-1.94|0.35|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||0.35|-1.94|0.17
91532057|NCT03527277|182940285|SUPERIORITY||Mean Difference (Net)|0.54||||0.65|TWO_SIDED|95.0|-1.9|3.0|||ANCOVA|Effect of group on change of outcome with adjustment for gender and BMI and outcome at baseline.||||3.0|-1.9|0.65
91532058|NCT03527277|182940286|SUPERIORITY||Mean Difference (Net)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.6|-0.5|0.88
91749763|NCT00901511|183392072|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.0315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.0315
91749764|NCT00901511|183392073|SUPERIORITY||Mean Difference (Final Values)|-3689.0||||0.03|TWO_SIDED|95.0|-6972.0|-406.0|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the KL-6 levels in the GM-CSF Group minus the KL-6 levels in the Control Group|Primary Analysis||-406|-6972|0.0300
91532059|NCT03527277|182940287|SUPERIORITY||Mean Difference (Net)|0.6||||0.81|TWO_SIDED|95.0|-4.4|5.7|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5.7|-4.4|0.81
91532060|NCT03527277|182940288|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.4|2.9|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||2.9|-4.4|0.69
91532061|NCT03527277|182940289|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|Effect of group on change of outcome with adjustment for gender and outcome at baseline.||||0.1|-1.0|0.10
91532062|NCT03527277|182940290|SUPERIORITY||Mean Difference (Net)|-0.4||||0.55|TWO_SIDED|95.0|-2.1|1.2|||ANCOVA|Effect of group on change of Outcome with adjustment for outcome at baseline.||||1.2|-2.1|0.55
91505129|NCT02120950|182880041|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.7109|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.||0.6|-0.9|0.7109
91505130|NCT02120950|182880042|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.1||||0.8355|TWO_SIDED|95.0|-9.2|11.3|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.||11.3|-9.2|0.8355
91505131|NCT02120950|182880043|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.5069|TWO_SIDED|95.0|-2.9|1.4|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.||1.4|-2.9|0.5069
91749765|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-3265.0||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0770
91505132|NCT02120950|182880044|SUPERIORITY_OR_OTHER_LEGACY||Difference %|-0.6||||0.8423|TWO_SIDED|95.0|-6.3|5.1||The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12.|Cochran-Mantel-Haenszel||CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12.|||5.1|-6.3|0.8423
91749766|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-5018.0||||0.0745|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0745
91749767|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-6343.0||||0.2581|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.2581
91749768|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-4102.0||||0.4894|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.4894
91505133|NCT02424383|182880045|OTHER||||||||||||||||||Freedom from Target LesionRevascularization (TLR) were reported through 12 months with frequency counts, percentages and 95% confidence intervals from exact binomial test. In addition, Kaplan-Meier tables and curves were created.|||
91505134|NCT02424383|182880046|OTHER||||||||||||||||||Freedom from composite of safety events from the time following the index procedure through 30 days post procedure were reported with frequency counts, percentages and 95% confidence intervals from exact binomial test. Kaplan-Meier tables and curves were also calculated.|||
91505135|NCT01928862|182880069|OTHER||Treatment difference|-31.3|||||TWO_SIDED|90.0|-58.8|0.8||||||Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||0.8|-58.8|
91505136|NCT01928862|182880069|OTHER||Treatment Difference|6.3|||||TWO_SIDED|90.0|-25.3|36.9||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||36.9|-25.3|
91749769|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-6818.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
91749770|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-1570.0||||0.8633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.8633
91749771|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-4200.0||||0.3401|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.3401
91505137|NCT01928862|182880069|OTHER||Treatment Difference|-4.5|||||TWO_SIDED|90.0|-33.5|26.3||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||26.3|-33.5|
91505138|NCT02053753|182880092|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometrc Means (CP4:CP2)|1.084|||||TWO_SIDED|90.0|0.995|1.181|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.181|0.995|
91749772|NCT00901511|183392073|SUPERIORITY||Median Difference (Final Values)|-4307.0||||0.2973|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.2973
91749773|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.22|TWO_SIDED|95.0|-0.44|-0.04|||Repeated measures ANOVA||Calculated as the between group difference in the serum Cyfra21.1 levels in the GM-CSF Group minus the serum Cyfra21.1 levels in the Control Group|Primary Analysis||-0.04|-0.44|0.220
91749774|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-14.19|STANDARD_ERROR_OF_MEAN|6.76||0.056|TWO_SIDED|95.0|-28.8|0.42|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|•The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.42|-28.80|0.0560
91749775|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.15||0.0648|TWO_SIDED|95.0|-8.8|0.29|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||0.29|-8.80|0.0648
91749776|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|2.36||0.0175|TWO_SIDED|95.0|-11.28|-1.25|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-1.25|-11.28|0.0175
91749777|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
91749778|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|1.82||0.0089|TWO_SIDED|95.0|-9.27|-1.56|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-1.56|-9.27|0.0089
91749779|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|2.24||0.0343|TWO_SIDED|95.0|-9.92|-0.43|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-0.43|-9.92|0.0343
91749780|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.33||0.0871|TWO_SIDED|95.0|-9.21|0.69|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||0.69|-9.21|0.0871
91749781|NCT00901511|183392074|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.4||0.2265|TWO_SIDED|95.0|-8.09|2.06|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.06|-8.09|0.2265
91749782|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|8.78||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.3865
91749783|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|7.82||||0.1672|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.1672
91749784|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|4.24||||0.4363|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.4363
91749785|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|7.34||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
91749786|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|13.71||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
91749787|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|11.1||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.3865
91749788|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|5.4||||0.6475|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||• Calculated as the difference at the 18-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.6475
91749789|NCT00901511|183392075|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.6481|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.6481
91749790|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.78||0.0582|TWO_SIDED|95.0|-3.17|0.06|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.06|-3.17|0.0582
91749791|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|1.09||0.3068|TWO_SIDED|95.0|-1.17|3.48|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||3.48|-1.17|0.3068
91749792|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.75||0.5647|TWO_SIDED|95.0|-2.04|1.15|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||1.15|-2.04|0.5647
91749793|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.59||0.1669|TWO_SIDED|95.0|-2.11|0.4|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||0.40|-2.11|0.1669
91749794|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.69||0.453|TWO_SIDED|95.0|-1.99|0.93|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||0.93|-1.99|0.4530
91749795|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.71||0.4594|TWO_SIDED|95.0|-2.04|0.97|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||0.97|-2.04|0.4594
91749796|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.6302|TWO_SIDED|95.0|-1.61|1.0|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||1.00|-1.61|0.6302
91749797|NCT00901511|183392076|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.24|0.8|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||0.80|-2.24|0.3300
91505139|NCT02053753|182880093|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometric Means (CP4:CP2)|1.028|||||TWO_SIDED|90.0|0.934|1.131|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.131|0.934|
91505140|NCT02439320|182880101|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.001|TWO_SIDED|95.0|1.6|3.0|||Regression, Logistic|||||3.0|1.6|<0.001
91505141|NCT02439320|182880101|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|2.0|3.6|||Regression, Logistic|||||3.6|2.0|<0.001
91505142|NCT02439320|182880102|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
91505143|NCT02439320|182880102|SUPERIORITY||Odds Ratio, log|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
91505144|NCT02439320|182880103|SUPERIORITY||Odds Ratio, log|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
91505145|NCT02439320|182880103|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.001|TWO_SIDED|95.0|1.9|3.3|||Regression, Logistic|||||3.3|1.9|<0.001
91505146|NCT02439320|182880104|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.029|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|||||2.8|1.1|=0.029
91505147|NCT02439320|182880104|SUPERIORITY||Odds Ratio (OR)|2.1|||=|0.002|TWO_SIDED|95.0|1.3|3.4|||Regression, Logistic|||||3.4|1.3|=0.002
91505148|NCT02439320|182880105|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Regression, Logistic|||||0.5|0.3|<0.001
91505149|NCT02439320|182880105|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Regression, Logistic|||||0.4|0.2|<0.001
91505150|NCT02439320|182880106|SUPERIORITY||Odds Ratio, log|0.7||||0.12|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.120
91505151|NCT02439320|182880106|SUPERIORITY||Odds Ratio (OR)|0.6||||0.035|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.035
91505152|NCT02439320|182880108|SUPERIORITY||Odds Ratio (OR)|1.1||||0.386|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.386
91505153|NCT02439320|182880108|SUPERIORITY||Odds Ratio (OR)|1.1||||0.47|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.470
91505154|NCT02439320|182880109|SUPERIORITY||Odds Ratio (OR)|1.4||||0.006|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.006
91505155|NCT02439320|182880109|SUPERIORITY||Odds Ratio (OR)|1.3||||0.037|TWO_SIDED|95.0|1.0|1.6|||Regression, Logistic|||||1.6|1.0|0.037
91505156|NCT02439320|182880110|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.5|2.4|||Regression, Logistic|||||2.4|1.5|<0.001
91505157|NCT02439320|182880110|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|2.2|||Regression, Logistic|||||02.2|1.4|<0.001
91505158|NCT02404350|182880160|SUPERIORITY||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.78|5.79|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||5.79|2.78|<0.0001
91505159|NCT02404350|182880160|SUPERIORITY||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|2.35|4.87|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||4.87|2.35|<0.0001
91505160|NCT02404350|182880160|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.16|6.63|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||6.63|3.16|<0.0001
91505161|NCT02404350|182880161|SUPERIORITY||Difference in Mean|-0.61|STANDARD_ERROR_OF_MEAN|0.22||0.0061|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0061
91505162|NCT02404350|182880161|SUPERIORITY||Difference in Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0048
91505163|NCT02404350|182880161|SUPERIORITY||Difference in Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0003|||||||Non-parametric ANCOVA model||For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0003
91505164|NCT02404350|182880162|SUPERIORITY||Odds Ratio (OR)|10.15|||<|0.0001|TWO_SIDED|95.0|5.52|18.63|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||18.63|5.52|<0.0001
91505165|NCT02404350|182880162|SUPERIORITY||Odds Ratio (OR)|11.66|||<|0.0001|TWO_SIDED|95.0|6.37|21.37|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||21.37|6.37|<0.0001
91505166|NCT02404350|182880162|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|9.56|34.12|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||34.12|9.56|<0.0001
91505167|NCT02404350|182880163|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.31|8.83|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||8.83|2.31|<0.0001
91505168|NCT02404350|182880163|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.0001|TWO_SIDED|95.0|3.18|11.87|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||11.87|3.18|<0.0001
91505169|NCT02404350|182880163|SUPERIORITY||Odds Ratio (OR)|12.55|||<|0.0001|TWO_SIDED|95.0|6.43|24.48|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||24.48|6.43|<0.0001
91749798|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-53.72|STANDARD_ERROR_OF_MEAN|38.79||0.1864|TWO_SIDED|95.0|-136.4|28.96|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.96|-136.4|0.1864
91749799|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-21.17|STANDARD_ERROR_OF_MEAN|46.3||0.6541|TWO_SIDED|95.0|-119.8|77.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||77.51|-119.8|0.6541
91505170|NCT02404350|182880164|SUPERIORITY||Odds Ratio, log|5.37|||<|0.0001|TWO_SIDED|95.0|3.3|8.73|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||8.73|3.30|<0.0001
91505171|NCT02404350|182880164|SUPERIORITY||Odds Ratio (OR)|6.37|||<|0.0001|TWO_SIDED|95.0|3.93|10.32|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||10.32|3.93|<0.0001
91505172|NCT02404350|182880164|SUPERIORITY||Odds Ratio (OR)|7.43|||<|0.0001|TWO_SIDED|95.0|4.61|12.0|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||12.00|4.61|<0.0001
91505173|NCT02404350|182880165|SUPERIORITY|Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|Treatment contrast in LS mean (Change)|-0.24|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.15|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.15|-0.32|<0.0001
91505174|NCT02404350|182880165|SUPERIORITY||Treatment Contrast in LS mean (Change)|-0.23|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.14|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.14|-0.32|<0.0001
91505175|NCT02404350|182880165|SUPERIORITY||Treatment Contrast inj LS mean (Change)|-0.33|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.42|-0.24|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.24|-0.42|<0.0001
91505176|NCT02404350|182880166|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
91505177|NCT02404350|182880166|SUPERIORITY||Treatment Contrast in LS Mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
91505178|NCT02404350|182880166|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.86|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.05|-0.67|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.67|-1.05|<0.0001
91505179|NCT02404350|182880167|SUPERIORITY||Odds Ratio (OR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||||1.19|0.47|0.2250
91505180|NCT02404350|182880167|SUPERIORITY||Odds Ratio (OR)|0.45||||0.0004|TWO_SIDED|95.0|0.29|0.7|||Regression, Logistic|||||0.70|0.29|0.0004
91505181|NCT02404350|182880167|SUPERIORITY||Odds Ratio, log|0.44||||0.0004|TWO_SIDED|95.0|0.28|0.69|||Regression, Logistic|||||0.69|0.28|0.0004
91505182|NCT02404350|182880168|SUPERIORITY||Odds Ratio (OR)|0.37||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Regression, Logistic|||||0.65|0.22|0.0004
91505183|NCT02404350|182880168|SUPERIORITY||Odds Ratio (OR)|0.34||||0.0003|TWO_SIDED|95.0|0.19|0.6|||Regression, Logistic|||||0.60|0.19|0.0003
91505184|NCT02404350|182880168|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||||0.44|0.13|<0.0001
91505185|NCT05389657|182880169|SUPERIORITY||Odds Ratio (OR)|0.617||||0.47|TWO_SIDED|95.0|0.167|2.283|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on training completion, with a random intercept at the agency level. Covariates included prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||2.283|0.167|0.47
91513410|NCT02328326|182898539|SUPERIORITY||Mean Difference (Net)|0.17||||0.33|TWO_SIDED|95.0|-0.17|0.51|||Regression, Linear|Model was adjusted for baseline value of A1c, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.||0.51|-0.17|0.33
91749800|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-18.78|STANDARD_ERROR_OF_MEAN|24.58||0.456|TWO_SIDED|95.0|-70.89|33.33|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||33.33|-70.89|0.4560
91749801|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-28.44|STANDARD_ERROR_OF_MEAN|30.98||0.3721|TWO_SIDED|95.0|-94.12|37.23|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||37.23|-94.12|0.3721
91749802|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-28.78|STANDARD_ERROR_OF_MEAN|20.58||0.1812|TWO_SIDED|95.0|-72.41|14.86|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||14.86|-72.41|0.1812
91749803|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-26.11|STANDARD_ERROR_OF_MEAN|23.38||0.2805|TWO_SIDED|95.0|-75.67|23.44|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||23.44|-75.67|0.2805
91505186|NCT05389657|182880170|SUPERIORITY||adjusted group difference unstandardized|-1.268||||0.29|TWO_SIDED|95.0|-3.618|1.083|||Regression, Linear|multilevel linear regression with restricted maximum likelihood (REML) estimation||We used linear multilevel models with restricted maximum likelihood (REML) estimation to examine the impact of training assignment (reference = live training) on knowledge acquisition at post-training, with a random intercept at the agency level. Covariates included baseline FBT-KA score, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||1.083|-3.618|.29
91505187|NCT05389657|182880171|SUPERIORITY||Odds Ratio (OR)|1.16||||0.92|TWO_SIDED|95.0|0.07|19.293|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on engagement in FBT consultation at 12 months, with a random intercept at the agency level. Covariates included baseline intent to seek FBT consultation, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||19.293|0.070|0.92
91505188|NCT00944450|182880176|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)|Geometric Mean Ratio|1.05||||||90.0|1.02|1.07||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.07|1.02|
91505189|NCT00944450|182880177|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)|Geometric Mean Ratio|1.07||||||90.0|0.94|1.22||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.22|0.94|
91505190|NCT02864251|182880211|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0528|TWO_SIDED|95.0|0.56|1.0||Log-rank test stratified by PD-L1 expression (\>= 1% vs \<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.|Log Rank||Arm A over Arm C Stratified Cox proportional hazard model.|||1.00|0.56|0.0528
91505191|NCT02864251|182880211|SUPERIORITY||Hazard Ratio (HR)|2.07|||||TWO_SIDED|95.0|1.43|2.99|||||Arm B over Arm C Stratified Cox proportional hazard model.|||2.99|1.43|
91505192|NCT02864251|182880212|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.218|TWO_SIDED|95.0|0.62|1.12|||Log Rank||Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model|||1.12|0.62|0.2180
91505193|NCT02864251|182880212|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.75|1.52|||||Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.|||1.52|0.75|
91505194|NCT02864251|182880213|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.75|2.16|||||Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.|||2.16|0.75|
91505195|NCT03144180|182880238|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.|Confidence Interval for a mean|49.0|STANDARD_DEVIATION|47.0|||TWO_SIDED|95.0|15.459|82.571||||||||82.571|15.459|
91505196|NCT03144180|182880239|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.0295||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.0295
91505197|NCT03144180|182880240|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.403||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.403
91749804|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-27.33|STANDARD_ERROR_OF_MEAN|22.75||0.247|TWO_SIDED|95.0|-75.56|20.89|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||20.89|-75.56|0.2470
91749805|NCT00901511|183392077|SUPERIORITY||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|23.57||0.207|TWO_SIDED|95.0|-80.97|18.97|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||18.97|-80.97|0.2070
91749806|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.149|TWO_SIDED|95.0|-1.88|11.33|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the difference in the mean value of the SF-36 General Health Score in the GM-CSF Group minus the Control Group|Primary analysis||11.33|-1.88|0.1490
91749807|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|-4.31|STANDARD_ERROR_OF_MEAN|12.07||0.7263|TWO_SIDED|95.0|-30.04|21.43|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||21.43|-30.04|0.7263
91749808|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|8.29||0.3298|TWO_SIDED|95.0|-9.24|25.91|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||25.91|-9.24|0.3298
91749809|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|13.89|STANDARD_ERROR_OF_MEAN|6.48||0.0478|TWO_SIDED|95.0|-0.15|27.62|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||27.62|-0.15|0.0478
91749810|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|17.78|STANDARD_ERROR_OF_MEAN|7.37||0.0281|TWO_SIDED|95.0|2.16|33.39|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||33.39|2.16|0.0281
91749811|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|11.67|STANDARD_ERROR_OF_MEAN|10.07||0.2634|TWO_SIDED|95.0|-9.67|33.0|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||33.00|-9.67|0.2634
91749812|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|10.49||0.3548|TWO_SIDED|95.0|-12.24|32.24|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.24|-12.24|0.3548
91749813|NCT00901511|183392078|SUPERIORITY||Mean Difference (Final Values)|16.67|STANDARD_ERROR_OF_MEAN|9.68||0.1043|TWO_SIDED|95.0|-3.85|37.18|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||37.18|-3.85|0.1043
91749814|NCT02880514|183392079|SUPERIORITY|||||||0.0391||||||P-value not adjusted for multiplicity.|McNemar|McNemar's exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.||||||0.0391
91749815|NCT02880514|183392080|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
91749816|NCT02436668|183392081|SUPERIORITY||Hazard Ratio (HR)|1.525|||<|0.0001|TWO_SIDED|95.0|1.241|1.873||P-value is from log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.873|1.241|<0.0001
91749817|NCT02436668|183392082|SUPERIORITY|P-value is based on log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Hazard Ratio (HR)|1.109||||0.3225|TWO_SIDED|95.0|0.903|1.363|||Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.363|0.903|0.3225
91749818|NCT02436668|183392084|SUPERIORITY||Risk Ratio (RR)|0.695||||0.0058|TWO_SIDED|95.0|0.535|0.903|||Cochran-Mantel-Haenszel|||For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||0.903|0.535|0.0058
91749819|NCT02436668|183392086|SUPERIORITY||Risk Ratio (RR)|0.85||||0.0488|TWO_SIDED|95.0|0.722|1.0|||Cochran-Mantel-Haenszel||This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.|For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||1.0|0.722|0.0488
91749820|NCT02436668|183392087|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.0782|TWO_SIDED|95.0|0.975|1.642||P-value is from log-rank test stratified by the three randomization stratification factors.|Log Rank|||\[1\] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio \< 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by \>= 10 points without any further improvement in score by \>= 10 points or any further available QoL data due to dropout after deterioration.||1.642|0.975|0.0782
91749821|NCT02436668|183392088|SUPERIORITY|||||||0.3343|||||||Chi-squared|||"For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.~\[1\] P value is based on Chi-square test."||||0.3343
91749822|NCT01444027|183392102|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status||||||0.002
91749823|NCT01444027|183392102|SUPERIORITY|||||||0.9||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|||||||0.90
91749824|NCT01444027|183392102|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.002
91749825|NCT01444027|183392103|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for the baseline value of the measure, hospice agency, and bereaved status.||||||0.001
91749826|NCT01444027|183392103|SUPERIORITY|||||||0.48||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.48
91749827|NCT01444027|183392103|SUPERIORITY|||||||0.01||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||.01
91749828|NCT01444027|183392104|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
91505198|NCT01272830|182880242|SUPERIORITY|||||||0.0063||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data.||||0.0063
91749829|NCT01444027|183392104|SUPERIORITY|||||||0.83|||||||Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.83
91749830|NCT01444027|183392104|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
91749831|NCT01444027|183392105|SUPERIORITY|||||||0.003||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.003
91749832|NCT01444027|183392105|SUPERIORITY|||||||0.16||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.16
91749833|NCT01444027|183392105|SUPERIORITY|||||||0.17||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.17
91749834|NCT01444027|183392106|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
91749835|NCT01444027|183392106|SUPERIORITY|||||||0.78||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.78
91749836|NCT01444027|183392106|SUPERIORITY|||||||0.004||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.004
91749837|NCT03551665|183392108|OTHER||Mean Difference (Final Values)|0.029||||0.036|TWO_SIDED|95.0|0.002|0.056|||Regression, Linear|||These data are the immediate improvements (base 2 - post 1) in the MS group.||0.056|.002|0.036
91749838|NCT03551665|183392109|OTHER||Spearman's Rho|0.019||||0.92|||||||Spearman Correlation|||We correlated cognition (SDMT; above) to the improvement in performance (margin of stability) to to determine whether cognition predicted improvement in stepping outcomes.||||.92
91749839|NCT03551665|183392110|OTHER||Mean Difference (Final Values)|0.026||||0.119||95.0|-0.007|0.059|||Regression, Linear|||We assessed the change in reactive step length before (Baseline 2) to immediately after (post 1) training in the MS group||0.059|-0.007|0.119
91749840|NCT03551665|183392111|OTHER||Mean Difference (Final Values)|-0.041||||0.012||95.0|-0.073|-0.009|||Regression, Linear|||We assessed the change in reactive step latency before (Baseline 2) to immediately after (post 1) training in the MS group||-0.009|-0.073|0.012
91749841|NCT05538312|183392112|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|168.9|||||TWO_SIDED|90.0|157.66|180.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||180.94|157.66|
91749842|NCT05538312|183392113|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|152.19|||||TWO_SIDED|90.0|136.9|169.18|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.18|136.90|
91749843|NCT05538312|183392114|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|161.99|||||TWO_SIDED|90.0|148.7|176.47|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||176.47|148.70|
91749844|NCT05538312|183392115|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|153.13|||||TWO_SIDED|90.0|138.51|169.3|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.30|138.51|
91749845|NCT05538312|183392116|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|171.63|||||TWO_SIDED|90.0|159.96|184.15|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||184.15|159.96|
91749846|NCT05538312|183392117|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|157.8|||||TWO_SIDED|90.0|146.51|169.95|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.95|146.51|
91749847|NCT05538312|183392122|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.86|||||TWO_SIDED|90.0|178.86|207.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||207.94|178.86|
91749848|NCT01514240|183392132|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than -10% in FAS Population.|Difference of proportion|5.4||||0.526|TWO_SIDED|90.0|-8.49|18.94|||Chi-squared|||The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.||18.94|-8.49|0.526
91749849|NCT01514240|183392133|SUPERIORITY_OR_OTHER||Difference of proportion|1.8||||0.768|TWO_SIDED|90.0|-8.54|12.15|||Chi-squared||Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||12.15|-8.54|0.768
91749850|NCT01514240|183392134|SUPERIORITY_OR_OTHER||Difference of proportion|8.9||||0.208|TWO_SIDED|90.0|-2.87|20.58|||Chi-squared||Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||20.58|-2.87|0.208
91749851|NCT01514240|183392135|SUPERIORITY_OR_OTHER||LS mean difference between group|-22.8|STANDARD_ERROR_OF_MEAN|11.89||0.058|TWO_SIDED|90.0|-42.55|-3.09|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-3.09|-42.55|0.058
91749852|NCT01514240|183392136|SUPERIORITY_OR_OTHER||LS mean difference between group|-30.0|STANDARD_ERROR_OF_MEAN|12.05||0.014|TWO_SIDED|90.0|-49.95|-9.96|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-9.96|-49.95|0.014
91749853|NCT01514240|183392137|SUPERIORITY_OR_OTHER||LS mean difference between group|-21.4|STANDARD_ERROR_OF_MEAN|14.53||0.144|TWO_SIDED|90.0|-45.47|2.74|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.74|-45.47|0.144
91749854|NCT01514240|183392141|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
91749855|NCT01514240|183392142|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|1.66|29.61|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||29.61|1.66|
91505199|NCT01272830|182880242|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Changes from baseline data||||>0.05
91749856|NCT01514240|183392143|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|0.85|30.29|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||30.29|0.85|
91749857|NCT01514240|183392144|SUPERIORITY_OR_OTHER||Difference of proportions|7.1|||||TWO_SIDED|90.0|-5.67|19.71|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||19.71|-5.67|
91749858|NCT01514240|183392145|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
91749859|NCT01514240|183392146|SUPERIORITY_OR_OTHER||Difference of proportions|12.5|||||TWO_SIDED|90.0|-2.44|26.68|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||26.68|-2.44|
91749860|NCT01514240|183392147|SUPERIORITY_OR_OTHER||LS mean difference between group|10.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|90.0|4.86|16.14|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||16.14|4.86|
91749861|NCT01514240|183392148|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|90.0|6.07|19.11|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.11|6.07|
91749862|NCT01514240|183392149|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|4.31|||TWO_SIDED|90.0|5.4|19.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.72|5.40|
91749863|NCT01514240|183392150|SUPERIORITY_OR_OTHER||LS mean difference between group|14.1|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|90.0|6.9|21.23|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||21.23|6.90|
91749864|NCT01514240|183392151|SUPERIORITY_OR_OTHER||LS mean difference between group|3.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|1.49|5.29|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.29|1.49|
91749865|NCT01514240|183392152|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|1.64|5.97|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.97|1.64|
91505200|NCT01272830|182880243|SUPERIORITY|||||||0.0226||||||Significance threshold p\<0.5|paired|||Change from baseline data (HSS pain walking)||||0.0226
91505201|NCT01272830|182880243|SUPERIORITY|||||||0.0375||||||Significance threshold P\<0.05|paired t-test|||Change from baseline data (HSS total score)||||0.0375
91505202|NCT01272830|182880243|SUPERIORITY|||||||0.0391||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data (KSS knee pain)||||0.0391
91505203|NCT01272830|182880243|SUPERIORITY|||||||0.2137|||||||paired t-test|||Changes from baseline data (HSS pain walking)||||0.2137
91505204|NCT01272830|182880243|SUPERIORITY|||||||0.1312|||||||paired t-test|||Change from baseline data (HSS total score)||||0.1312
91749866|NCT01514240|183392153|SUPERIORITY_OR_OTHER||LS mean difference between group|4.1|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|90.0|1.58|6.64|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.64|1.58|
91749867|NCT01514240|183392154|SUPERIORITY_OR_OTHER||LS mean difference between group|3.3|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|0.9|5.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.76|0.90|
91749868|NCT01514240|183392155|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|0.89|3.17|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.17|0.89|
91749869|NCT01514240|183392156|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|0.73|3.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.19|0.73|
91749870|NCT01514240|183392157|SUPERIORITY_OR_OTHER||LS mean difference between group|2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.96|3.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.76|0.96|
91749871|NCT01514240|183392158|SUPERIORITY_OR_OTHER||LS mean difference between group|2.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|1.15|4.09|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||4.09|1.15|
91505205|NCT01272830|182880243|SUPERIORITY|||||||0.1578|||||||paired t-test|||Change from baseline data (KSS knee pain)||||0.1578
91505206|NCT01272830|182880244|SUPERIORITY|||||||0.0083||||||Significance threshold p\<0.05|t-test|||Changes from baseline data||||0.0083
91505207|NCT01272830|182880244|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Change from baseline data||||>0.05
91505208|NCT01272830|182880245|SUPERIORITY|||||||0.01||||||Significance threshold p\<0.05|ANOVA|||Change from baseline data||||0.01
91505209|NCT01272830|182880245|SUPERIORITY||||||>|0.05|||||||paired t-test|Significant threshold p\<0.05||Changes from baseline data||||>0.05
91505210|NCT00751348|182880246|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.|Difference in percentage|-1.36|||<|0.05|TWO_SIDED|95.0|-3.77|1.66||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.||1.66|-3.77|<0.05
91532063|NCT02459587|182940308|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person. VCL contacts with and without suicide ideation were combined, due to low counts.|Hazard Ratio (HR)|1.24|STANDARD_ERROR_OF_MEAN|0.222||0.33|TWO_SIDED|95.0|0.8|1.92||2-tailed P-value above was calculated from type III test.|Regression, Cox|Model was structured to allow multiple events per person. No covariates.|Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.218 (SEM=0.222)|||1.92|0.80|0.33
91532064|NCT02459587|182940309|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person.|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.153|<|0.0001|TWO_SIDED|95.0|0.38|0.7||All tests of significance were 2-tailed. P-value above is type III. No covariates.|Regression, Cox||Cox Proportional Hazards Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.660 (SEM=0.153)|||0.70|0.38|<0.0001
91532065|NCT02459587|182940310|SUPERIORITY|Two binary variables were derived from Treatment Services Review responses to identify any general mental health service utilization, one binary variable for Baseline and another for any outpatient mental health service utilization at any time point in the 1 year follow-up period. The Baseline variable was included as a main-effects covariate.|Odds Ratio, log|1.146||||0.66|TWO_SIDED|95.0|0.604|2.176|||Regression, Logistic|Bivariate logistic, adjusted for (1) if any general outpatient mental heath visits at baseline (0) otherwise||||2.176|0.604|0.66
91532066|NCT02028884|182940316|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0184|TWO_SIDED|95.0|0.16|0.88|||Log Rank|||Stratified by Baseline annualized relapse rate (ARR: 1, \> 1) and geographic region (Asia, EU/Other).||0.88|0.16|0.0184
91505211|NCT00751348|182880246|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%.|Difference in percentage|-5.34|||<|0.05|TWO_SIDED|95.0|-10.4|0.38||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.||0.38|-10.4|<0.05
91749872|NCT01514240|183392159|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|90.0|1.44|6.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.19|1.44|
91505212|NCT00751348|182880246|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%.|Difference in percentage|-0.34|||<|0.05|TWO_SIDED|95.0|-1.88|2.06||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.||2.06|-1.88|<0.05
91505213|NCT00751348|182880246|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%.|Difference in percentage|-1.06|||<|0.05|TWO_SIDED|95.0|-3.07|1.44||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.||1.44|-3.07|<0.05
91532067|NCT02028884|182940317|SUPERIORITY||Mean Difference (Final Values)|6.376|STANDARD_ERROR_OF_MEAN|3.344||0.0602|TWO_SIDED|95.0|-0.28|13.033|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||13.033|-0.280|0.0602
91532068|NCT02028884|182940318|SUPERIORITY||Mean Difference (Final Values)|-2.089|STANDARD_ERROR_OF_MEAN|1.338||0.1224|TWO_SIDED|95.0|-4.752|0.574|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||0.574|-4.752|0.1224
91532069|NCT05176353|182940347|SUPERIORITY|||||||0.86|||||||Z-score test for person-time rates|||||||0.86
91532070|NCT05176353|182940348|SUPERIORITY|||||||0.05|||||||Z-score test for person-time rates|||||||0.05
91532071|NCT05176353|182940349|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||0.59
91749873|NCT01514240|183392160|SUPERIORITY_OR_OTHER||LS mean difference between group|4.9|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|2.14|7.65|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.65|2.14|
91749874|NCT01514240|183392161|SUPERIORITY_OR_OTHER||LS mean difference between group|4.3|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|1.4|7.25|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.25|1.40|
91749875|NCT01514240|183392162|SUPERIORITY_OR_OTHER||LS mean difference between group|6.6|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|3.56|9.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||9.72|3.56|
91749876|NCT01514240|183392163|SUPERIORITY_OR_OTHER||LS mean difference between group|1.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.01|2.43|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.43|0.01|
91749877|NCT01514240|183392164|SUPERIORITY_OR_OTHER||LS mean difference between group|1.8|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|90.0|0.42|3.12|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.12|0.42|
91749878|NCT01514240|183392165|SUPERIORITY_OR_OTHER||LS mean difference between group|1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|0.19|3.04|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.04|0.19|
91749879|NCT01514240|183392166|SUPERIORITY_OR_OTHER||LS mean difference between group|1.3|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.15|2.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.76|-0.15|
91749880|NCT05858450|183392174|OTHER||Weighted Hazard Ratio|1.108|||||TWO_SIDED|95.0|1.018|1.205||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an inverse probability of treatment weights (IPTW) was applied. Analysis performed using IPTW method.||1.205|1.018|
91749881|NCT05858450|183392174|OTHER||Weighted Hazard Ratio|0.634|||||TWO_SIDED|95.0|0.606|0.664||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.664|0.606|
91749882|NCT05858450|183392175|OTHER||Weighted Hazard Ratio|1.061|||||TWO_SIDED|95.0|1.016|1.107||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.107|1.016|
91749883|NCT05858450|183392175|OTHER||Weighted Hazard Ratio|0.897|||||TWO_SIDED|95.0|0.875|0.919||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.919|0.875|
91505214|NCT03583996|182880255|OTHER||Negative Likelihood Ratio (NLR)|0.293|||||TWO_SIDED|95.0|0.097|0.882||||||The performance goal for validation of DSI ≤18.3 was the upper limit of the confidence interval (CI) for negative likelihood ratio (NLR) to rule out an NLR of \>0.52. For the null and alternate hypotheses, the upper limit of the 95% CI was NLR \>0.52 and the upper limit of the 95% CI was NLR \<=0.52, respectively. The confidence level for the CI was adjusted to maintain a 1-sided type I error rate of 0.025.||0.882|0.097|
91532072|NCT05176353|182940350|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
91749884|NCT05858450|183392176|OTHER||Weighted Hazard Ratio|1.543|||||TWO_SIDED|95.0|1.133|2.1||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.1|1.133|
91749885|NCT05858450|183392176|OTHER||Weighted Hazard Ratio|1.106|||||TWO_SIDED|95.0|1.014|1.206||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.206|1.014|
91749886|NCT05858450|183392177|OTHER||Weighted Hazard Ratio|1.048|||||TWO_SIDED|95.0|0.903|1.217||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.217|0.903|
91505215|NCT03583996|182880255|OTHER||Sensitivity|0.917|||||TWO_SIDED|95.0|0.775|0.982||||||The performance goal for validation of DSI \<= 18.3 was the observed sensitivity must have been \>0.85. The confidence level for the confidence interval (CI) was adjusted to maintain a 1-sided type I error rate of 0.025.||0.982|0.775|
91532073|NCT05176353|182940351|SUPERIORITY|||||||0.2|||||||Z-score test for person-time rates|||||||0.20
91532074|NCT05176353|182940352|SUPERIORITY|||||||0.03|||||||Z-score test for person-time rates|||||||0.03
91532075|NCT05176353|182940353|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
91749887|NCT05858450|183392177|OTHER||Weighted Hazard Ratio|0.908|||||TWO_SIDED|95.0|0.846|0.973||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.973|0.846|
91749888|NCT05858450|183392178|OTHER||Weighted Hazard Ratio|1.137|||||TWO_SIDED|95.0|1.068|1.211||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.211|1.068|
91749889|NCT05858450|183392178|OTHER||Weighted Hazard Ratio|1.057|||||TWO_SIDED|95.0|1.007|1.11||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.11|1.007|
91749890|NCT05858450|183392179|OTHER||Weighted Hazard Ratio|0.761|||||TWO_SIDED|95.0|0.718|0.807||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.807|0.718|
91749891|NCT05858450|183392179|OTHER||Weighted Hazard Ratio|0.858|||||TWO_SIDED|95.0|0.811|0.907||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.907|0.811|
91749892|NCT05858450|183392180|OTHER||Weighted Hazard Ratio|1.55|||||TWO_SIDED|95.0|0.88|2.731||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.731|0.88|
91532076|NCT05176353|182940354|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||.05
91505216|NCT03583996|182880256|OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.047|1.143||The odds ratio was for a 1-unit increase in DSI based on continuous DSI.|Regression, Logistic|Unadjusted (no covariates)||||1.143|1.047|<0.0001
91505217|NCT03583996|182880256|OTHER||Odds Ratio (OR)|1.109|||<|0.0001|TWO_SIDED|95.0|1.058|1.163|||Regression, Logistic|Adjusted for demographic covariates, including age, race, sex, BMI, and ethnicity.||||1.163|1.058|<0.0001
91505218|NCT03583996|182880256|OTHER||Odds Ratio (OR)|1.092|||<|0.001|TWO_SIDED|95.0|1.041|1.145|||Regression, Logistic|Adjusted for severity of liver disease covariates, compensated cirrhosis (CP class A)||||1.145|1.041|<0.001
91505219|NCT03583996|182880256|OTHER||Odds Ratio (OR)|1.089|||<|0.001|TWO_SIDED|95.0|1.038|1.142|||Regression, Logistic|Adjusted for severity of liver disease covariates, decompensated cirrhosis (CP class B)||||1.142|1.038|<0.001
91505220|NCT03969992|182880302|SUPERIORITY|||||||0.1924||||||A closed test procedure is used to protect the type I error rate; the order of testing was: AeroFact high dose compared to control and if significant (p-value \<0.05), the AeroFact low dose was compared to the control.|Generalized estimating equation method|||||||0.1924
91532077|NCT02037061|182940387|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
91749893|NCT05858450|183392180|OTHER||Weighted Hazard Ratio|1.035|||||TWO_SIDED|95.0|0.865|1.238||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.238|0.865|
91505221|NCT02063737|182880315|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3882||||0.083|TWO_SIDED|95.0|-0.8272|0.0508|||Mixed Models Analysis|adjusting for shift length|Adjusted difference between intervention groups (intervention - control) from the linear mixed model adjusting for shift length and repeated measures within individuals.|||0.0508|-0.8272|0.0830
91505222|NCT02063737|182880316|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0114
91532078|NCT00519779|182940390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033|STANDARD_ERROR_OF_MEAN|0.09||0.97|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|adjusted for baseline value, visit, gender, SAD||||0.18|-0.18|0.97
91532079|NCT00519779|182940391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED|95.0|-0.44|-0.011|||Mixed Models Analysis|||||-0.011|-0.44|0.04
91749894|NCT05858450|183392181|OTHER||Weighted Hazard Ratio|0.921|||||TWO_SIDED|95.0|0.687|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|0.687|
91505223|NCT02063737|182880317|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||.99
91505224|NCT02063737|182880318|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||ANCOVA|adjusted for baseline measure||||||0.0927
91505225|NCT02063737|182880319|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||0.0578
91505226|NCT02063737|182880320|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.69
91505227|NCT02063737|182880321|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.65
91505228|NCT02063737|182880322|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.95
91505229|NCT02063737|182880323|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.21
91532080|NCT00519779|182940392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.039||0.06|TWO_SIDED|95.0|-0.15|0.002|||Mixed Models Analysis|||||0.002|-0.15|0.06
91749895|NCT05858450|183392181|OTHER||Weighted Hazard Ratio|0.826|||||TWO_SIDED|95.0|0.722|0.945||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.945|0.722|
91505230|NCT02063737|182880324|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.51
91505231|NCT02063737|182880325|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.28
91505232|NCT02063737|182880326|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0930
91505233|NCT02063737|182880327|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.56
91505234|NCT02063737|182880328|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.20
91505235|NCT06049043|182880349|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|95.0|-14.02|3.84|||t-test, 2 sided|||||3.84|-14.02|0.26
91505236|NCT06049043|182880350|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|4.84||0.44|TWO_SIDED|95.0|-13.43|5.85|||t-test, 2 sided|||||5.85|-13.43|0.44
91505237|NCT06049043|182880351|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.62|TWO_SIDED|95.0|-0.66|1.1|||t-test, 2 sided|||||1.10|-0.66|0.62
91505238|NCT06049043|182880352|SUPERIORITY||Mean Difference (Final Values)|6.34|STANDARD_ERROR_OF_MEAN|0.04||0.16|TWO_SIDED|95.0|-2.5|15.18|||t-test, 2 sided|||||15.18|-2.50|0.16
91505239|NCT06049043|182880352|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.28|TWO_SIDED|95.0|-0.13|0.04|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.04|-0.13|0.28
91505240|NCT06049043|182880353|SUPERIORITY||Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|4.67||0.67|TWO_SIDED|95.0|-7.31|11.28|||t-test, 2 sided|||||11.28|-7.31|0.67
91505241|NCT06049043|182880353|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED|95.0|-0.12|0.08|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.08|-0.12|0.69
91505242|NCT06049043|182880354|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.32||0.09|TWO_SIDED|95.0|-0.09|1.18|||t-test, 2 sided|||||1.18|-0.09|0.09
91532081|NCT00519779|182940393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.072||0.04|TWO_SIDED|95.0|-0.3|-0.009|||Mixed Models Analysis|||||-0.009|-0.30|0.04
91532082|NCT00519779|182940394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.08|TWO_SIDED|95.0|-0.33|0.018|||Mixed Models Analysis|||||0.018|-0.33|0.08
91749896|NCT05858450|183392182|OTHER||Weighted Hazard Ratio|1.569|||||TWO_SIDED|95.0|1.088|2.264||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.264|1.088|
91749897|NCT05858450|183392182|OTHER||Weighted Hazard Ratio|1.118|||||TWO_SIDED|95.0|1.015|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|1.015|
91749898|NCT05858450|183392183|OTHER||Weighted Hazard Ratio|1.082|||||TWO_SIDED|95.0|0.911|1.286||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.286|0.911|
91749899|NCT05858450|183392183|OTHER||Weighted Hazard Ratio|0.932|||||TWO_SIDED|95.0|0.859|1.01||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.01|0.859|
91749900|NCT00395291|183392218|SUPERIORITY_OR_OTHER||||||<|0.001||||||The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.|ANCOVA|||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions.~Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis."||||<0.001
91749901|NCT00395291|183392219|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANCOVA|The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.169
91749902|NCT00395291|183392220|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions.~Because Leptin is considered a secondary outcome, no power analysis was conducted."||||0.063
91505243|NCT06049043|182880354|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.36||0.71|TWO_SIDED|95.0|-0.86|0.59|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.59|-0.86|0.71
91505244|NCT06049043|182880355|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.08|TWO_SIDED|95.0|-0.07|1.27|||t-test, 2 sided|||||1.27|-0.07|0.08
91505245|NCT06049043|182880355|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.42||0.39|TWO_SIDED|95.0|-1.21|0.48|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.48|-1.21|0.39
91505246|NCT06049043|182880357|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.89|TWO_SIDED|95.0|-0.95|0.82|||t-test, 2 sided|||||0.82|-0.95|0.89
91505247|NCT03089606|182880435|OTHER|2-tailed Fisher's exact test||||||0.08|||||||2-tailed Fisher's exact test|||Null hypothesis. No association between baseline C11-AMT PET SUVmax value and antitumor response to pembrolizumab.||||0.08
91749903|NCT00395291|183392221|SUPERIORITY_OR_OTHER|||||||0.075|||||||ANCOVA|The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions.~Because serum-insulin is considered a secondary outcome, no power analysis was conducted."||||0.075
91749904|NCT00395291|183392222|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.782
91749905|NCT00395291|183392223|SUPERIORITY_OR_OTHER|||||||0.385|||||||ANCOVA|The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.385
91505248|NCT00335972|182880441|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).|Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0||Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.|repeated measures ANOVA||mean difference: Dexmedetomidine arm - Remifentanil arm|||-5|-13|<0.001
91505249|NCT00335972|182880441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-4|-13|<0.001
91505250|NCT00335972|182880442|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group|Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).|repeated measures ANOVA model||mean difference: Dexmedetomidine arm - Remifentanil arm|||-1.1|-2.7|<0.001
91505251|NCT00335972|182880442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-0.9|-2.8|<0.001
91532083|NCT00519779|182940395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.14||0.93|TWO_SIDED|95.0|-0.26|0.29|||Mixed Models Analysis|||||0.29|-0.26|0.93
91532084|NCT03990363|182940410|SUPERIORITY|||||||0.0648|||||||Repeated Measures Mixed Model|||||||0.0648
91749906|NCT00395291|183392224|SUPERIORITY_OR_OTHER|||||||0.929|||||||ANCOVA|The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions.~Because CRPs is considered as a secondary outcome, no power analysis was conducted."||||0.929
91749907|NCT00395291|183392225|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions.~Because IL-1 is considered as a secondary outcome, no power analysis was conducted"||||0.905
91749908|NCT00395291|183392226|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||ANCOVA|||||||0.233
91749909|NCT00395291|183392227|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANCOVA|The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions.~Because IL-10 is considered as a secondary outcome, no power analysis was conducted."||||0.277
91749910|NCT00395291|183392228|SUPERIORITY_OR_OTHER|||||||0.875|||||||ANCOVA|The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.875
91749911|NCT00395291|183392229|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANCOVA|The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.545
91749912|NCT00395291|183392230|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.900
91749913|NCT02868034|183392232|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.025|TWO_SIDED|97.5|-0.26|0.22|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects at 4 weeks||0.22|-0.26|0.025
91749914|NCT02868034|183392232|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.025|TWO_SIDED|97.5|-0.43|0.09|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects after 12 weeks||0.09|-0.43|0.025
91749915|NCT02868034|183392232|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.025|TWO_SIDED|97.5|-0.11|0.38|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Treatment Component Main Effects at 4 weeks||0.38|-0.11|0.025
91749916|NCT02868034|183392232|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.025|TWO_SIDED|97.5|-0.23|0.29|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.29|-0.23|0.025
91749917|NCT02868034|183392232|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-0.45|0.04|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Activating Exercise Component Main Effect at 4 weeks||0.04|-0.45|0.025
91749918|NCT02868034|183392232|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.45|0.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater change when the component was used|Activating Exercise Component Main Effect at 12 weeks||0.07|-0.45|0.025
91505252|NCT00335972|182880443|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean|Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)|Wilcoxon (Mann-Whitney)||mean difference: Dexmedetomidine arm - Remifentanil|||-5|-10|<0.001
91505253|NCT00335972|182880443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority||-3|-10|<0.001
91749919|NCT02868034|183392232|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||0.32|-0.66|0.025
91749920|NCT02868034|183392232|SUPERIORITY||interaction relative mean difference|-0.1||||0.025|TWO_SIDED|97.5|-0.62|0.42|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||0.42|-0.62|0.025
91532085|NCT03990363|182940410|SUPERIORITY|||||||0.6296|||||||Repeated Measures Mixed Model|||||||0.6296
91532086|NCT03990363|182940410|SUPERIORITY|||||||0.0263|||||||Repeated Measures Mixed Model|||||||0.0263
91749921|NCT02868034|183392232|SUPERIORITY||interaction relative mean difference|0.13||||0.025|TWO_SIDED|97.5|-0.36|0.62|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||0.62|-0.36|0.025
91749922|NCT02868034|183392232|SUPERIORITY||interaction relative mean difference|0.5||||0.025|TWO_SIDED|97.5|-0.02|1.02|||Mixed Models Analysis|||||1.02|-0.02|0.025
91505254|NCT03965962|182880445|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 2) was greater than (\>) -5% at Day 28.|Difference in Percentage|-0.42|||||TWO_SIDED|95.0|-2.33|4.35||||||||4.35|-2.33|
91505255|NCT03965962|182880445|NON_INFERIORITY|The two-sided 95 % CI was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 3) was \> -5% at Day 28.|Difference in Percentage|0.86|||||TWO_SIDED|95.0|-1.32|6.5||||||||6.50|-1.32|
91749923|NCT02868034|183392232|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||0.32|-0.66|0.025
91749924|NCT02868034|183392232|SUPERIORITY||interaction relative mean difference|0.39||||0.025|TWO_SIDED|97.5|-0.13|0.91|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||0.91|-0.13|0.025
91749925|NCT02868034|183392232|SUPERIORITY||3-way interaction relative mean dif.|0.25||||0.025|TWO_SIDED|97.5|-0.24|0.74|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||0.74|-0.24|0.025
91749926|NCT02868034|183392232|SUPERIORITY||3-way interaction relative mean dif.|0.4||||0.025|TWO_SIDED|97.5|-0.12|0.92|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||0.92|-0.12|0.025
91749927|NCT02868034|183392233|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.67|1.52|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.||SMT Component Main Effects at 4 weeks|A positive value indicates greater improvement in muscle activation when the component was used|1.52|-2.67|0.025
91505256|NCT00867451|182880472|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<.05
91505257|NCT02039674|182880489|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|26.3||||0.0016|TWO_SIDED|95.0|8.9|42.1|||Miettinen & Nurminen Method|||||42.1|8.9|0.0016
91505258|NCT02039674|182880490|SUPERIORITY|||||||0.0858|||||||Exact binomial distribution for testing|HO: ORR ≤20% versus H1: ORR \>20%||||||0.0858
91749928|NCT02868034|183392233|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.025|TWO_SIDED|97.5|-2.76|2.02|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|SMT Component Main Effects at 12 weeks||2.02|-2.76|0.025
91749929|NCT02868034|183392233|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.025|TWO_SIDED|97.5|-2.03|2.16|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 4 weeks||2.16|-2.03|0.025
91749930|NCT02868034|183392233|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.025|TWO_SIDED|97.5|-1.68|3.11|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 12 weeks||3.11|-1.68|0.025
91749931|NCT02868034|183392233|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.025|TWO_SIDED|97.5|-2.94|1.25|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 4 weeks||1.25|-2.94|0.025
91749932|NCT02868034|183392233|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.97|1.82|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 12 weeks||1.82|-2.97|0.025
91749933|NCT02868034|183392233|SUPERIORITY||interaction relative mean difference|0.8||||0.025|TWO_SIDED|97.5|-3.39|4.99|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||4.99|-3.39|0.025
91505259|NCT02039674|182880492|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.00252|TWO_SIDED|95.0|0.35|0.83|||Log Rank|One-sided p-value based on log-rank test||||0.83|0.35|0.00252
91505260|NCT02039674|182880493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.06762|TWO_SIDED|95.0|0.45|1.12|||Log Rank|One-sided p-value based on log-rank test||||1.12|0.45|0.06762
91505261|NCT01358357|182880495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.078|TWO_SIDED|95.0|0.49|1.04||A hazard ratio of time to recurrence and its corresponding 95% Wald CI were estimated for the lurasidone arm vs.placebo arm, using a Cox proportional hazards model.Cox model included treatment effect as fixed effect, and stratified by pooled country.|Cox Proportional Hazards Model|||It was assumed that the recurrence event rates during the double-blind phase were to be 24% and 39% for subjects treated with lurasidone and placebo, respectively. A total of 120 recurrence events were required to achieve 90% power to detect the 15% difference in subjects who had a recurrence event during the double-blind phase between the treatment groups using a log-rank test with two sided alpha level of 0.05.||1.04|0.49|<0.078
91505262|NCT01358357|182880496|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||<|0.034|TWO_SIDED|95.0|0.54|0.98||A HR of time to discontinuation and corresponding 95% Wald CI were est. for lurasidone arm vs.the placebo arm, using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect,stratified by pooled country.|Cox Proportional Hazards Model|||||0.98|0.54|<0.034
91505263|NCT01358357|182880497|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72||||0.113|TWO_SIDED|95.0|0.48|1.08||A HR of time to recurrence and its corresponding 95% Wald CI were estimated for lurasidone arm vs. placebo arm,using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect stratified by pooled country.|Cox Proportional hazard Model|||||1.08|0.48|0.113
91505264|NCT01358357|182880499|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12||analysis of ANCOVA model contains treatment ,pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.12|-0.29|0.406
91749934|NCT02868034|183392233|SUPERIORITY||interaction relative mean difference|-0.68||||0.025|TWO_SIDED|97.5|-5.47|4.11|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||4.11|-5.47|0.025
91532087|NCT01563978|182940425|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|2.93||||0.023|TWO_SIDED|95.0|0.4|5.45|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.45|0.40|0.023
91749935|NCT02868034|183392233|SUPERIORITY||interaction relative mean difference|-1.56||||0.025|TWO_SIDED|97.5|-5.75|2.63|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||2.63|-5.75|0.025
91749936|NCT02868034|183392233|SUPERIORITY||interaction relative mean difference|1.42||||0.025|TWO_SIDED|97.5|-3.37|6.21|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||6.21|-3.37|0.025
91749937|NCT02868034|183392233|SUPERIORITY||interaction relative mean difference|-0.44||||0.025|TWO_SIDED|97.5|-4.63|3.75|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||3.75|-4.63|0.025
91749938|NCT02868034|183392233|SUPERIORITY||interaction relative mean difference|2.01||||0.025|TWO_SIDED|97.5|-2.77|6.8|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||6.80|-2.77|0.025
91749939|NCT02868034|183392233|SUPERIORITY||3-way interaction relative mean dif.|-0.18||||0.025|TWO_SIDED|97.5|-4.37|4.01|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.01|-4.37|0.025
91749940|NCT02868034|183392233|SUPERIORITY||3-way interaction relative mean dif.|0.56||||0.025|TWO_SIDED|97.5|-4.22|5.35|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||5.35|-4.22|0.025
91749941|NCT02868034|183392234|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.025|TWO_SIDED|97.5|-4.0|1.68|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 4-weeks||1.68|-4.0|0.025
91749942|NCT02868034|183392234|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-3.46|3.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 12-weeks||3.07|-3.46|0.025
91749943|NCT02868034|183392234|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.025|TWO_SIDED|97.5|-4.2|1.48|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 4-weeks||1.48|-4.2|0.025
91749944|NCT02868034|183392234|SUPERIORITY||Mean Difference (Final Values)|-1.72||||0.025|TWO_SIDED|97.5|-4.99|1.55|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 12-weeks||1.55|-4.99|0.025
91749945|NCT02868034|183392234|SUPERIORITY||Mean Difference (Final Values)|-2.34||||0.025|TWO_SIDED|97.5|-5.18|0.5|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Exercise Treatment Component main effect after 4-weeks||0.50|-5.18|0.025
91749946|NCT02868034|183392234|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.025|TWO_SIDED|97.5|-6.89|-0.35|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Treatment Component Main Effect after 12-weeks||-0.35|-6.89|0.025
91749947|NCT02868034|183392234|SUPERIORITY||interaction relative mean difference|3.24||||0.025|TWO_SIDED|97.5|-2.45|8.92|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||8.92|-2.45|0.025
91749948|NCT02868034|183392234|SUPERIORITY||interaction relative mean difference|4.34||||0.025|TWO_SIDED|97.5|-2.19|10.87|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||10.87|-2.19|0.025
91749949|NCT02868034|183392234|SUPERIORITY||interaction relative mean difference|0.57||||0.025|TWO_SIDED|97.5|-5.12|6.25|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||6.25|-5.12|0.025
91749950|NCT02868034|183392234|SUPERIORITY||interaction relative mean difference|-0.67||||0.025|TWO_SIDED|97.5|-7.2|5.87|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||5.87|-7.20|0.025
91505265|NCT01358357|182880500|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.11||||0.162|TWO_SIDED|95.0|-0.26|0.04||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.04|-0.26|0.162
91505266|NCT01358357|182880501|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.07||||0.496|TWO_SIDED|95.0|-0.27|0.13||Analysis of covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.13|-0.27|0.496
91749951|NCT02868034|183392234|SUPERIORITY||interaction relative mean difference|4.64||||0.025|TWO_SIDED|97.5|-1.04|10.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||10.32|-1.04|0.025
91749952|NCT02868034|183392234|SUPERIORITY||interaction relative mean difference|1.49||||0.025|TWO_SIDED|97.5|-5.04|8.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||8.02|-5.04|0.025
91505267|NCT01358357|182880502|SUPERIORITY_OR_OTHER||LS mean difference|-0.8||||0.128|TWO_SIDED|95.0|-1.8|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pool country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-1.8|0.128
91505268|NCT01358357|182880503|SUPERIORITY_OR_OTHER||LS mean difference lurasdione vs.Placebo|-0.5||||0.485|TWO_SIDED|95.0|-1.9|0.9||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.9|-1.9|0.485
91505269|NCT01358357|182880504|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.582|TWO_SIDED|95.0|-0.8|0.5||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.5|-0.8|0.582
91505270|NCT01358357|182880505|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.01||||0.42|TWO_SIDED|95.0|-0.5|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-0.5|0.420
91749953|NCT02868034|183392234|SUPERIORITY||3-way interaction relative mean dif.|-0.86||||0.025|TWO_SIDED|97.5|-6.54|4.82|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.82|-6.54|0.025
91532088|NCT01563978|182940426|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|3.53|||<|0.001|TWO_SIDED|95.0|2.04|5.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.03|2.04|<0.001
91532089|NCT01563978|182940427|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.3||||0.02|TWO_SIDED|95.0|0.53|6.08|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime SBP (Day 28)||6.08|0.53|0.020
91532090|NCT01563978|182940427|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.75|||<|0.001|TWO_SIDED|95.0|2.08|5.42|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime DBP (Day 28)||5.42|2.08|<0.001
91532091|NCT01563978|182940427|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.07||||0.179|TWO_SIDED|95.0|-0.96|5.11|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time SBP (Day 28)||5.11|-0.96|0.179
91749954|NCT02868034|183392234|SUPERIORITY||3-way interaction relative mean dif.|0.04||||0.025|TWO_SIDED|97.5|-6.5|6.57|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||6.57|-6.50|0.025
91749955|NCT02868034|183392235|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.025|TWO_SIDED|97.5|-0.6|0.32|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effect at 4-weeks||0.32|-0.60|0.025
91749956|NCT02868034|183392235|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.025|TWO_SIDED|97.5|-0.44|0.61|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effects at 12 weeks||0.61|-0.44|0.025
91749957|NCT02868034|183392235|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.025|TWO_SIDED|97.5|-0.92|0.0|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 4 weeks||0.0|-0.92|0.025
91505271|NCT01358357|182880506|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.2||||0.788|TWO_SIDED|95.0|-1.6|1.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||1.2|-1.6|0.788
91505272|NCT01358357|182880507|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.1|-0.3|0.380
91505273|NCT01358357|182880508|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|0.37||||0.772|TWO_SIDED|95.0|-2.14|2.88||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||2.88|-2.14|0.772
91505274|NCT00108160|182880513|SUPERIORITY_OR_OTHER|||||||0.356||||||No adjustments were made for multiple comparisons.|Chi-squared|||Our null hypothesis was that no significant effect of mupirocin ointment (treatment) on S. aureus re-infection would be seen at 18 months compared with placebo ointment. Based on prior studies, we estimated that 198 participants would need to be enrolled assuming a 20% dropout rate; 84 participants per arm would be required to detect a 66% decrease in re-infection from 30% to 10% with a significance level alpha of 0.05 and a power of 0.9.||||0.356
91749958|NCT02868034|183392235|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.025|TWO_SIDED|97.5|-0.7|0.34|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.34|-0.70|0.025
91749959|NCT02868034|183392235|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.025|TWO_SIDED|97.5|-0.62|0.3|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 4 weeks||0.30|-0.62|0.025
91749960|NCT02868034|183392235|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.71|0.33|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 12 weeks||0.33|-0.71|0.025
91749961|NCT02868034|183392235|SUPERIORITY||interaction relative mean difference|0.38||||0.025|TWO_SIDED|97.5|-0.54|1.3|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||1.30|-0.54|0.025
91749962|NCT02868034|183392235|SUPERIORITY||interaction relative mean difference|0.45||||0.025|TWO_SIDED|97.5|-0.6|1.49|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||1.49|-0.60|0.025
91749963|NCT02868034|183392235|SUPERIORITY||interaction relative mean difference|0.12||||0.025|TWO_SIDED|97.5|-0.8|1.04|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||1.04|-0.80|0.025
91505275|NCT00323492|182880568|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.42||||0.034||95.0|-0.86|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were applied.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.86|0.034
91505276|NCT00323492|182880569|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.36||||0.031||95.0|-0.67|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum text|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.67|0.031
91749964|NCT02868034|183392235|SUPERIORITY||interaction relative mean difference|0.23||||0.025|TWO_SIDED|97.5|-0.81|1.28|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||1.28|-0.81|0.025
91532092|NCT01563978|182940427|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.14|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time DBP (Day 28)||5.14|1.13|0.002
91749965|NCT02868034|183392235|SUPERIORITY||interaction relative mean difference|0.89||||0.025|TWO_SIDED|97.5|-0.03|1.81|||Mixed Models Analysis|||||1.81|-0.03|0.025
91749966|NCT02868034|183392235|SUPERIORITY||interaction relative mean difference|-0.02||||0.025|TWO_SIDED|97.5|-1.07|1.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||1.02|-1.07|0.025
91749967|NCT02868034|183392235|SUPERIORITY||3-way interaction relative mean dif.|0.71||||0.025|TWO_SIDED|97.5|-0.21|1.63|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||1.63|-0.21|0.025
91749968|NCT02868034|183392235|SUPERIORITY||3-way interaction relative mean dif.|0.0||||0.025|TWO_SIDED|97.5|-1.05|1.04|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||1.04|-1.05|0.025
91749969|NCT03640052|183392261|SUPERIORITY||Mean Difference (Final Values)|3.6|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
91532093|NCT01563978|182940428|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.11||||0.024|TWO_SIDED|95.0|0.41|5.81|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake SBP (Day 28)||5.81|0.41|0.024
91749970|NCT03640052|183392261|SUPERIORITY||Mean Difference (Net)|-2.0|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
91749971|NCT03640052|183392261|SUPERIORITY||Mean Difference (Net)|-6.8|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
91749972|NCT03640052|183392261|SUPERIORITY||Mean Difference (Net)|-11.7||||0.33|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||0.33
91749973|NCT03640052|183392262|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
91749974|NCT05479097|183392301|SUPERIORITY||Median Difference (Net)|-7.5||||0.03232|TWO_SIDED|95.0|-12.0|-1.0||A priori threshold for statistical significance was P \<0.05.|Wilcoxon signed rank test|Systolic blood pressure was not normally distributed in the study sample, so nonparametric analysis was used.||The null hypothesis was that there was no change in systolic blood pressure.||-1.0|-12.0|0.03232
91749975|NCT05479097|183392302|SUPERIORITY||Mean Difference (Net)|-3.1||||0.045|TWO_SIDED|95.0|-6.1|-0.1||The a priori threshold for statistical significance was P \<0.05.|t-test, 2 sided|As diastolic blood pressure was normally distributed in our sample, we used a paired t-test to evaluate the mean difference in measurements.||The null hypothesis was that there was no change in diastolic blood pressure.||-0.1|-6.1|0.045
91749976|NCT05479097|183392303|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was no change in the proportion of patients with systolic blood pressure well-controlled (\<=140 mmHg) from baseline to 6 months.||||0.7237
91749977|NCT05479097|183392304|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was that there was no difference in the proportion of patients with systolic blood pressure less than or equal to their personalized goal from baseline to 6 months.||||0.7237
91505277|NCT00323492|182880570|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.009||95.0|-0.18|-0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.02|-0.18|0.009
91505278|NCT00323492|182880571|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.64|||<|0.001||95.0|-1.01|-0.27||No adjustments for multiple comparisons were made.|Wicoxon Rank Sum test|no adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.27|-1.01|< 0.001
91505279|NCT00323492|182880572|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.51||95.0|-0.44|0.19||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.19|-0.44|0.51
91505280|NCT00323492|182880573|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.79||95.0|-0.03|0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.02|-0.03|0.79
91532094|NCT01563978|182940428|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.66|||<|0.001|TWO_SIDED|95.0|2.1|5.22|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake DBP (Day 28)||5.22|2.10|<0.001
91532095|NCT01563978|182940429|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|1.99||||0.223|TWO_SIDED|95.0|-1.22|5.2|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping SBP||5.20|-1.22|0.223
91749978|NCT01035346|183392327|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|8.33||||0.228|TWO_SIDED|95.0|-7.94|24.6||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.||24.60|-7.94|0.228
91749979|NCT01035346|183392328|SUPERIORITY_OR_OTHER||LS mean difference|5.99||||0.171|TWO_SIDED|95.0|-3.99|15.97||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||15.97|-3.99|0.171
91749980|NCT01035346|183392328|SUPERIORITY_OR_OTHER||LS mean difference|8.96||||0.354|TWO_SIDED|95.0|-14.78|32.69||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||32.69|-14.78|0.354
91749981|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.576|TWO_SIDED|95.0|-0.84|0.54||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.54|-0.84|0.576
91749982|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.502|TWO_SIDED|95.0|-0.5|0.87||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.50|0.502
91749983|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|1.31||||0.116|TWO_SIDED|95.0|-0.51|3.12||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|-0.51|0.116
91749984|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.161|TWO_SIDED|95.0|-0.98|4.14||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|-0.98|0.161
91505281|NCT00323492|182880574|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.86
91505282|NCT00323492|182880576|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.65
91749985|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|1.87||||0.215|TWO_SIDED|95.0|-1.66|5.41||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.41|-1.66|0.215
91749986|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|1.17||||0.388|TWO_SIDED|95.0|-2.18|4.52||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.52|-2.18|0.388
91749987|NCT01035346|183392329|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.849|TWO_SIDED|95.0|-3.98|4.61||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.61|-3.98|0.849
91749988|NCT01035346|183392331|SUPERIORITY_OR_OTHER||difference in proportion|11.11||||0.378|TWO_SIDED|95.0|-10.67|32.89||p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.||32.89|-10.67|0.378
91749989|NCT01035346|183392332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.324|TWO_SIDED|95.0|-0.3|1.27||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.27|-0.30|0.324
91749990|NCT01035346|183392333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.21|TWO_SIDED|95.0|-0.12|1.18||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.18|-0.12|0.210
91749991|NCT01459653|183392343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3038|TWO_SIDED|95.0|0.6989|1.1182|||Chi-squared|||||1.1182|0.6989|0.3038
91505283|NCT00323492|182880577|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.11
91749992|NCT01459653|183392344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1897||||0.1432|TWO_SIDED|95.0|0.9428|1.5012|||Chi-squared|||||1.5012|0.9428|0.1432
91749993|NCT01459653|183392345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8794||||0.6483|TWO_SIDED|95.0|0.5063|1.5276|||Chi-squared|||||1.5276|0.5063|0.6483
91749994|NCT01459653|183392355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2989|||<|0.0001|TWO_SIDED|95.0|1.8113|2.9177|||Chi-squared|||||2.9177|1.8113|<0.0001
91505284|NCT00323492|182880577|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.34
91749995|NCT01459653|183392356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4963|||<|0.0001|TWO_SIDED|95.0|0.373|0.6605|||Chi-squared|||||0.6605|0.3730|<0.0001
91749996|NCT01459653|183392357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9451||||0.7509|TWO_SIDED|95.0|0.6671|1.3391|||Chi-squared|||||1.3391|0.6671|0.7509
91749997|NCT01459653|183392358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2683||||0.0067|TWO_SIDED|95.0|1.068|1.5061|||Chi-squared|||||1.5061|1.0680|0.0067
91749998|NCT01459653|183392366|SUPERIORITY_OR_OTHER||Slope|1.0628|||<|0.0001|TWO_SIDED|95.0|0.6382|1.4874|||ANOVA|degrees of freedom: 4507||||1.4874|0.6382|<0.0001
91749999|NCT01459653|183392367|SUPERIORITY_OR_OTHER||Slope|-0.2739||||0.0103|TWO_SIDED|95.0|-0.4832|-0.0646|||ANOVA|degrees of freedom: 4507||||-0.0646|-0.4832|0.0103
91750000|NCT01459653|183392368|SUPERIORITY_OR_OTHER||Slope|0.3812|||<|0.0001|TWO_SIDED|95.0|0.233|0.5295|||ANOVA|degrees of freedom: 4495||||0.5295|0.2330|<0.0001
91750001|NCT01459653|183392376|SUPERIORITY_OR_OTHER||Slope|0.1031||||0.0677|TWO_SIDED|95.0|-0.0075|0.2136|||ANOVA|degrees of freedom: 4516||||0.2136|-0.0075|0.0677
91750002|NCT01459653|183392377|SUPERIORITY_OR_OTHER||Slope|0.0018||||0.8968|TWO_SIDED|95.0|-0.0259|0.0295|||ANOVA|degrees of freedom: 4516||||0.0295|-0.0259|0.8968
91750003|NCT01459653|183392378|SUPERIORITY_OR_OTHER||Slope|0.0741|||<|0.0001|TWO_SIDED|95.0|-0.0452|0.1029|||ANOVA|degrees of freedom: 4505||||0.1029|-0.0452|<0.0001
91750004|NCT01459653|183392386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.2698|TWO_SIDED|95.0|0.4255|1.2698|||Chi-squared|||||1.2698|0.4255|0.2698
91750005|NCT01459653|183392387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
91750006|NCT01459653|183392404|SUPERIORITY_OR_OTHER|||||||0.5977|TWO_SIDED||||||Log Rank|||||||0.5977
91750007|NCT01459653|183392405|SUPERIORITY_OR_OTHER|||||||0.2435|TWO_SIDED||||||Log Rank|||||||0.2435
91750008|NCT01459653|183392406|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||Log Rank|||||||0.7630
91750009|NCT01459653|183392407|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED||||||Log Rank|||||||0.3830
91750010|NCT01459653|183392408|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
91750011|NCT01459653|183392409|SUPERIORITY_OR_OTHER|||||||0.0301|TWO_SIDED||||||Log Rank|||||||0.0301
91750012|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|0.92||||0.0683|TWO_SIDED|95.0|0.84|1.01|||Regression, Logistic|degrees of freedom: 3181||GCSF treatment decision (under vs correct) as predictor for ANC||1.01|0.84|0.0683
91750013|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|0.89||||0.0019|TWO_SIDED|95.0|0.82|0.96|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Over vs correct) as predictor for ANC||0.96|0.82|0.0019
91750014|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|1.04||||0.4469|TWO_SIDED|95.0|0.94|1.15|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Under vs over) as predictor for ANC||1.15|0.94|0.4469
91750015|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|1.11||||0.0079|TWO_SIDED|95.0|1.03|1.19|||Regression, Logistic|||Study drug dose (higher vs lower) as predictor for ANC||1.19|1.03|0.0079
91750016|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|0.81||||0.0004|TWO_SIDED|95.0|0.72|0.91|||Regression, Logistic|||Tumor type (hematological vs solid) as predictor for ANC||0.91|0.72|0.0004
91750017|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.92|||Regression, Logistic|||Patient gender (female vs male) as predictor for ANC||0.92|0.80|<0.0001
91750018|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|1.04||||0.0235|TWO_SIDED|95.0|1.01|1.08|||Regression, Linear|||ECOG (per 1 point) as predictor for ANC||1.08|1.01|0.0235
91750019|NCT01459653|183392410|SUPERIORITY_OR_OTHER||Slope|1.03|||<|0.0001|TWO_SIDED|95.0|1.02|1.05|||Regression, Linear|||Hb (per g/dL) as predictor for ANC||1.05|1.02|<0.0001
91750020|NCT01459653|183392411|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.09||||0.0003|TWO_SIDED||||||ANCOVA||The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.|ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.||||0.0003
91750021|NCT01459653|183392411|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.41|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.||||<0.0001
91750022|NCT01459653|183392411|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.||||<0.0001
91750023|NCT01459653|183392416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.544||||0.003|TWO_SIDED|95.0|0.365|0.812|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode||0.812|0.365|0.003
91750024|NCT01459653|183392416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.795|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
91750025|NCT01459653|183392416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.083|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
91750026|NCT01459653|183392416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.542|3.925|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||3.925|1.542|<0.001
91750027|NCT01459653|183392416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.452||||0.003|TWO_SIDED|95.0|0.267|0.766|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.766|0.267|0.003
91750028|NCT01459653|183392417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.925||||0.001|TWO_SIDED|95.0|1.592|5.374|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||5.374|1.592|0.001
91750029|NCT01459653|183392417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.572||||0.005|TWO_SIDED|95.0|1.331|4.969|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode||4.969|1.331|0.005
91750030|NCT01459653|183392417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.328|||<|0.001|TWO_SIDED|95.0|0.193|0.557|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.557|0.193|<0.001
91750031|NCT01459653|183392418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|||<|0.001|TWO_SIDED|95.0|1.284|2.179|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for FN episode||2.179|1.284|<0.001
91750032|NCT01459653|183392418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.704|||<|0.001|TWO_SIDED|95.0|2.777|7.968|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode||7.968|2.777|<0.001
91750033|NCT01459653|183392418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.002|TWO_SIDED|95.0|1.342|3.574|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for FN episode||3.574|1.342|0.002
91750034|NCT01459653|183392418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.215||||0.01|TWO_SIDED|95.0|0.067|0.687|||Regression, Logistic|||History of anaemia at enrollment as patient-level predictor for FN episode||0.687|0.067|0.010
91750035|NCT01459653|183392418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.501||||0.025|TWO_SIDED|95.0|1.169|10.487|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||10.487|1.169|0.025
91750036|NCT01459653|183392419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.975||||0.003|TWO_SIDED|95.0|0.958|0.991|||Regression, Logistic|||Patient age (per 1 year) as patient-level predictor for FN episode||0.991|0.958|0.003
91750037|NCT01459653|183392419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.398|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for FN episode||3.570|1.610|<0.001
91750038|NCT01459653|183392419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.562||||0.001|TWO_SIDED|95.0|1.45|4.527|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for FN episode||4.527|1.450|0.001
91750039|NCT01459653|183392419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.232|||<|0.001|TWO_SIDED|95.0|0.108|0.499|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for FN episode||0.499|0.108|<0.001
91750040|NCT01459653|183392419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.261||||0.011|TWO_SIDED|95.0|1.315|8.084|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||8.084|1.315|0.011
91750041|NCT01459653|183392420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.814|||<|0.001|TWO_SIDED|95.0|1.397|2.355|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization||2.355|1.397|<0.001
91750042|NCT01459653|183392420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.296|||<|0.001|TWO_SIDED|95.0|1.791|6.065|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization||6.065|1.791|<0.001
91750043|NCT01459653|183392420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.205||||0.001|TWO_SIDED|95.0|1.38|3.524|||Regression, Logistic|||CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization||3.524|1.380|0.001
91750044|NCT01459653|183392420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.863||||0.032|TWO_SIDED|95.0|1.054|3.293|||Regression, Logistic|||Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||3.293|1.054|0.032
91750045|NCT01459653|183392420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.385||||0.024|TWO_SIDED|95.0|0.168|0.879|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.879|0.168|0.024
91505285|NCT00323492|182880578|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments were made.|Fisher Exact|No adjustments were made.||Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response||||1.00
91505286|NCT02486042|182880592|OTHER|T-test for equality in means. The p-value threshold for significance was p \< 0.05.||||||0.22|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T0 blood samples in the Standard of Care versus Omegaven group||||0.22
91505287|NCT02486042|182880592|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.15|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T0 blood samples in the Standard of Care versus Omegaven group||||0.15
91532096|NCT01563978|182940429|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.87||||0.007|TWO_SIDED|95.0|0.81|4.93|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping DBP||4.93|0.81|0.007
91532097|NCT01563978|182940430|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.24||||0.2|TWO_SIDED|95.0|-1.2|5.69|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic SBP (Day 29)||5.69|-1.20|0.200
91532098|NCT01563978|182940430|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.36||||0.046|TWO_SIDED|95.0|0.05|4.68|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic DBP (Day 29)||4.68|0.05|0.046
91532099|NCT01563978|182940431|SUPERIORITY_OR_OTHER||Least square means treatment difference|6.31|||<|0.001|TWO_SIDED|95.0|3.6|9.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home SBP (Week 4)||9.03|3.60|<0.001
91505288|NCT02486042|182880592|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.78|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T0 blood samples in the Standard of Care versus Omegaven group||||0.78
91505289|NCT02486042|182880596|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.43|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T1 blood samples in the Standard of Care versus Omegaven group||||0.43
91532100|NCT01563978|182940431|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.58|||<|0.001|TWO_SIDED|95.0|2.91|6.25|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home DBP (Week 4)||6.25|2.91|<0.001
91505290|NCT02486042|182880596|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.44|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T1 blood samples in the Standard of Care versus Omegaven group||||0.44
91532101|NCT01563978|182940432|SUPERIORITY_OR_OTHER||Least square means treatment difference|7.22|||<|0.001|TWO_SIDED|95.0|4.29|10.16|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home SBP (Week 4)||10.16|4.29|<0.001
91532102|NCT01563978|182940432|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.74|||<|0.001|TWO_SIDED|95.0|2.9|6.59|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home DBP (Week 4)||6.59|2.90|<0.001
91532103|NCT01563978|182940434|SUPERIORITY_OR_OTHER||Least square means treatment difference|0.74|||<|0.001|TWO_SIDED|95.0|0.4|1.08||Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)|ANCOVA|||Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.||1.08|0.40|<0.001
91532104|NCT01875861|182940492|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.02|1.38||||||Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.||1.38|1.02|
91532105|NCT01875861|182940493|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.03|1.39||||||See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.||1.39|1.03|
91532106|NCT03824535|182940542|SUPERIORITY|||||||0.02||||||The threshold for statistical significance was set at p \< 0.05|Wilcoxon (Mann-Whitney)|||Analysis applies to the row 'Specificity' in the Outcome Measure data table.||||0.02
91505291|NCT02486042|182880596|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.5|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T1 blood samples in the Standard of Care versus Omegaven group||||0.50
91505292|NCT02486042|182880597|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
91505293|NCT02486042|182880597|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
91505294|NCT02486042|182880597|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T2 blood samples in the Standard of Care versus Omegaven group||||0.01
91750046|NCT01459653|183392420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.843||||0.001|TWO_SIDED|95.0|1.964|11.942|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||11.942|1.964|0.001
91750047|NCT01459653|183392421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.473|||<|0.001|TWO_SIDED|95.0|1.55|3.946|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization||3.946|1.550|<0.001
91750048|NCT01459653|183392421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.382||||0.002|TWO_SIDED|95.0|0.21|0.695|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.695|0.210|0.002
91750049|NCT01459653|183392421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.108||||0.001|TWO_SIDED|95.0|1.56|6.192|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||6.192|1.560|0.001
91750050|NCT01459653|183392422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.931|||<|0.001|TWO_SIDED|95.0|5.426|14.699|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance||14.699|5.426|<0.001
91505295|NCT01466387|182880599|NON_INFERIORITY_OR_EQUIVALENCE|GMC TF+YF+MenACWY-CRM/GMC TF+YF.|Ratio of GMC|1.14|||||TWO_SIDED|95.0|0.81|1.6||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.6|0.81|
91505296|NCT01466387|182880600|NON_INFERIORITY_OR_EQUIVALENCE|GMT TF+YF+MenACWY/GMT TF+YF.|Ratio of GMT.|0.96|||||TWO_SIDED|95.0|0.65|1.41||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.41|0.65|
91505297|NCT01466387|182880601|NON_INFERIORITY_OR_EQUIVALENCE|GMT JE + Rab + MenACWY-CRM/GMT JE + Rab.|Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.7|1.16||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and centers as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.16|0.7|
91505298|NCT01466387|182880602|NON_INFERIORITY_OR_EQUIVALENCE|GMC JE + Rab + MenACWY-CRM/GMC JE + Rab.|Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.71|1.17||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.17|0.71|
91532107|NCT03824535|182940543|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was predefined as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.004
91532108|NCT03824535|182940543|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was predefined as p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||||||0.05
91505299|NCT02530450|182880613|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Testing the change between two time points within each group using Wilcoxon signed rank test.||||< 0.05
91505300|NCT02586896|182880662|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
91532109|NCT03824535|182940543|SUPERIORITY|||||||0.06||||||The threshold for statistical significance was predefined as p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.06
91532110|NCT06403605|182940555|SUPERIORITY|||||||0.78||||||Adjusted p value in the mITT analysis population.|Mixed Models Analysis|||||||0.78
91750051|NCT01459653|183392422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.336||||0.007|TWO_SIDED|95.0|0.152|0.74|||Regression, Logistic|||Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance||0.740|0.152|0.007
91750052|NCT01459653|183392422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.006|TWO_SIDED|95.0|0.999|1.0|||Regression, Logistic|||Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.000|0.999|0.006
91750053|NCT01459653|183392422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001|||<|0.001|TWO_SIDED|95.0|1.0|1.001|||Regression, Logistic|||Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.001|1.000|<0.001
91750054|NCT01459653|183392422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.456||||0.024|TWO_SIDED|95.0|1.127|5.353|||Regression, Logistic|||Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||5.353|1.127|0.024
91750055|NCT01459653|183392422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.344||||0.01|TWO_SIDED|95.0|1.342|8.331|||Regression, Logistic|||Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||8.331|1.342|0.010
91750056|NCT01459653|183392423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.965||||0.006|TWO_SIDED|95.0|1.218|3.172|||Regression, Logistic|||Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance||3.172|1.218|0.006
91750057|NCT01459653|183392423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.594||||0.001|TWO_SIDED|95.0|1.469|4.581|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance||4.581|1.469|0.001
91750058|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.424|0.821|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.821|0.424|0.002
91750059|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.644||||0.003|TWO_SIDED|95.0|0.489|0.859|||Regression, Logistic|||Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.859|0.489|0.003
91750060|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.004|TWO_SIDED|95.0|0.398|0.842|||Regression, Logistic|||Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.842|0.398|0.004
91750061|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.369||||0.001|TWO_SIDED|95.0|1.14|1.643|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||1.643|1.140|0.001
91750062|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.499|||<|0.001|TWO_SIDED|95.0|2.456|4.985|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||4.985|2.456|<0.001
91750063|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.064|||<|0.001|TWO_SIDED|95.0|3.096|5.336|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.336|3.096|<0.001
91750064|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.545||||0.002|TWO_SIDED|95.0|1.175|2.033|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.033|1.175|0.002
91505301|NCT02586896|182880664|SUPERIORITY|||||||0.91|||||||ANOVA|||||||0.91
91505302|NCT02586896|182880665|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
91505303|NCT02586896|182880666|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
91532111|NCT06403605|182940555|SUPERIORITY|||||||0.48||||||Adjusted p value in the PP analysis population.|Mixed Models Analysis|||||||0.48
91505304|NCT00403273|182880707|SUPERIORITY|||||||0.01||||||p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.01
91505305|NCT00403273|182880708|SUPERIORITY_OR_OTHER||comparison of proportions|0.65|||<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome|comparison of proportions|compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths \& all timepoints|we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.|For primary outcome analysis, we compared the proportion of responders with clinically meaningful change \[improvement\] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.||||<0.05
91505306|NCT00403273|182880709|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91532112|NCT06403605|182940556|SUPERIORITY|||||||0.049||||||Adjusted p-value in the mITT population.|Log Rank|||||||0.049
91505307|NCT00403273|182880710|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91505308|NCT00403273|182880711|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91505309|NCT00403273|182880712|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91505310|NCT00403273|182880713|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91532113|NCT06403605|182940556|SUPERIORITY|||||||0.084||||||Adjusted p value in the PP population.|Log Rank|||||||0.084
91532114|NCT06403605|182940559|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
91750065|NCT01459653|183392424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.596||||0.017|TWO_SIDED|95.0|1.088|2.34|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.340|1.088|0.017
91750066|NCT01459653|183392425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.621||||0.006|TWO_SIDED|95.0|1.152|2.281|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.281|1.152|0.006
91750067|NCT01459653|183392425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.898||||0.005|TWO_SIDED|95.0|1.209|2.979|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.979|1.209|0.005
91750068|NCT01459653|183392425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.016|TWO_SIDED|95.0|1.2|5.984|||Regression, Logistic|||History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.984|1.200|0.016
91750069|NCT01459653|183392425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438|||<|0.001|TWO_SIDED|95.0|0.291|0.66|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.660|0.291|<0.001
91750070|NCT01459653|183392425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.053||||0.002|TWO_SIDED|95.0|1.295|3.256|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||3.256|1.295|0.002
91750071|NCT01459653|183392425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.558||||0.028|TWO_SIDED|95.0|0.332|0.939|||Regression, Logistic|||GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.939|0.332|0.028
91505311|NCT00380393|182880769|OTHER||Vaccine Efficacy|52.9|||<|0.001|TWO_SIDED|95.0|28.1|69.1|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum||69.1|28.1|<0.001
91750072|NCT01459653|183392426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2064||||0.0116|TWO_SIDED|95.0|1.1931|4.0803|||Regression, Logistic|||Patient level predictor: History of anemia at enrollment||4.0803|1.1931|0.0116
91750073|NCT01459653|183392426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3049||||0.0057|TWO_SIDED|95.0|1.2754|4.1656|||Regression, Logistic|||Liver/renal/cardiac comorbidity as patient level predictor||4.1656|1.2754|0.0057
91505312|NCT00380393|182880769|OTHER||Vaccine Efficacy|55.0|||<|0.001|TWO_SIDED|95.0|31.4|70.4|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum||70.4|31.4|<0.001
91505313|NCT00380393|182880770|OTHER||Vaccine efficacy|54.6|||<|0.001|TWO_SIDED|95.0|31.2|70.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||70.0|31.2|<0.001
91505314|NCT00380393|182880770|OTHER||Vaccine efficacy|56.5|||<|0.001|TWO_SIDED|95.0|34.2|71.2|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum.||71.2|34.2|<0.001
91750074|NCT01459653|183392426|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.535|||<|0.0001|TWO_SIDED|95.0|8.2159|37.4243|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient level predictor||37.4243|8.2159|<0.0001
91505315|NCT00380393|182880771|OTHER||Vaccine efficacy|55.8||||0.0003|TWO_SIDED|95.0|31.0|71.7|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||71.7|31.0|0.0003
91505316|NCT00380393|182880771|OTHER||Vaccine efficacy|57.9|||<|0.001|TWO_SIDED|95.0|34.3|73.0|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.3|<0.001
91750075|NCT01459653|183392430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Female gender as patient-level predictor for cancer-related mortality||37.1225|5.9567|<0.0001
91750076|NCT01459653|183392430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient-level predictor||37.1225|5.9567|<0.0001
91750077|NCT00457821|183392441|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
91750078|NCT00457821|183392442|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
91750079|NCT00457821|183392444|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
91505317|NCT00380393|182880772|OTHER||Vaccine efficacy|58.0|||<|0.001|TWO_SIDED|95.0|34.8|73.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.8|<0.001
91505318|NCT00380393|182880772|OTHER||Vaccine efficacy|59.5|||<|0.001|TWO_SIDED|95.0|37.1|73.9|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.9|37.1|<0.001
91505319|NCT01536496|182880791|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||Chi-square test||||0.04
91505320|NCT03865329|182880810|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91505321|NCT03865329|182880811|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91505322|NCT03865329|182880813|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
91505323|NCT03865329|182880814|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
91505324|NCT00265616|182880815|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91505325|NCT00265616|182880816|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Fisher Exact|||||||0.67
91505326|NCT00265616|182880817|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
91505327|NCT00265616|182880819|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||||||0.4
91505328|NCT00265616|182880820|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
91505329|NCT00278954|182880831|SUPERIORITY_OR_OTHER||SABI per subject per year|0.0||||0.01||99.0|0.0|0.101|||Poisson regression with log link||Mean SABI rate = 0 per subject per year. 1-sided 99% upper confidence bound could not be calculated.|The estimated serious acute bacterial infection (SABI) rate was calculated by dividing no. of infections by no.of subject years. The exponential of the upper limit of the 98% 2-sided Confidence Interval (CI) gave the upper, 1-sided, 99% confidence bound, estimated using Poisson regression. The equivalent upper bound per subject year was obtained by dividing this figure by total subject years.||0.101|0|0.01
91505330|NCT03760796|182880837|OTHER||Hazard Ratio (HR)|0.48||||0.018|TWO_SIDED|95.0|0.26|0.88||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||0.88|0.26|0.018
91750080|NCT02139878|183392447|SUPERIORITY_OR_OTHER||||||=|0.088|||||||ANCOVA|||||||=0.088
91750081|NCT02139878|183392448|SUPERIORITY_OR_OTHER||||||=|0.98|||||||ANCOVA|||||||=0.980
91750082|NCT00027378|183392474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.702||0.05||95.0|||||ANOVA|repeated measures||Repeated measures ANOVA||||.05
91750083|NCT00737568|183392485|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.||||0.43
91750084|NCT01133626|183392498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of a two-sided 95% CI for the geometric mean ratio of BDP HFA 320 mcg/day to placebo was greater than 0.80.|geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|||||1.06|0.87|
91750085|NCT00835640|183392509|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|81.33||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
91750086|NCT00835640|183392510|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.87||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
91750087|NCT00835640|183392511|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.45||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
91750088|NCT00350272|183392512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-13.5|||||TWO_SIDED|95.0|-35.2|8.2||||||The difference in proportions between the group of participants who received lamivudine 300 mg/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of participants who received elvucitabine 10 mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.||8.2|-35.2|
91505331|NCT03760796|182880838|OTHER|A Markov Model of cost-effectiveness, based on 30-day readmission rates, was built to assess the Incremental Cost-Effectiveness Ratio (ICER) of adopting the Corrie Platform compared to standard of care for post AMI patients; taking into account the estimated cost of Corrie ($2,750 per patient for a 1-year use term). The reported value is a ratio of the relative cost of intervention compared to the standard of care divided by the change in the outcome, quality-adjusted life years (QALYs).|Incremental Cost-Effectiveness Ratio|-7.0|||||TWO_SIDED||||||||A negative ICER means the intervention cost is lower than the cost of standard of care, while the denominator was positive. A positive ICER means the intervention cost is greater than the cost of standard of care, while the denominator was positive.|||||
91505332|NCT03760796|182880852|OTHER||Hazard Ratio (HR)|1.45||||0.33|TWO_SIDED|95.0|0.69|2.98||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||2.98|0.69|0.33
91532115|NCT07083843|182940560|SUPERIORITY||Mean Difference (Final Values)|4.115|STANDARD_DEVIATION|2.8||0.05|TWO_SIDED|95.0|2.87|5.36|||paired sample T-test.|Degree of freedom = 25||Data was analyzed using SPSS v22.0., Descriptive statistics will summarize baseline variables. Paired t-test will assess pre- vs. post - intervention scores within groups, and between-group differences will be compared, the null hypothesis states there is no difference between intervention and control groups. A two-tailed P\< 0.05 will be considered statistically significant.||5.36|2.87|0.05
91750089|NCT00812006|183392514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
91750090|NCT00812006|183392515|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
91750091|NCT00812006|183392516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
91750092|NCT00812006|183392517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's falsediscovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
91750093|NCT00812006|183392518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
91750094|NCT00068250|183392519|OTHER||||||||||||||||||Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.|||
91505333|NCT02211131|182880857|OTHER||Hazard Ratio (HR)|0.75||||0.07|TWO_SIDED|80.0|0.58|0.96||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.96|0.58|0.070
91505334|NCT02211131|182880858|OTHER||Hazard Ratio (HR)|0.76||||0.092|TWO_SIDED|80.0|0.6|0.97||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.97|0.60|0.092
91750095|NCT00068250|183392520|SUPERIORITY|||||||0.006|||||||One-sample z-test|||Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)||||0.006
91750096|NCT00068250|183392521|OTHER|||||||0.82|||||||Chi-squared|One-sample test of proportions||RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.||||0.82
91750097|NCT03955250|183392540|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91750098|NCT03955250|183392541|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
91750099|NCT03955250|183392541|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
91750100|NCT03955250|183392542|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|time||||||>0.05
91750101|NCT03955250|183392542|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
91750102|NCT03955250|183392543|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
91750103|NCT03955250|183392543|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
91750104|NCT03242772|183392580|OTHER|||||||0.2664||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -3.5729 - 11.6929|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.2664
91750105|NCT03242772|183392581|OTHER|||||||0.3721||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -17.7698 - 7.2698|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.3721
91750106|NCT02499900|183392583|SUPERIORITY||Mean Difference (Final Values)|0.321|||<|0.001|TWO_SIDED|95.0|0.1615|0.4814||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as MSQ is not measured at baseline for these patients.||0.4814|0.1615|<0.001
91750107|NCT02499900|183392584|SUPERIORITY||Mean Difference (Final Values)|9.448|||<|0.001|TWO_SIDED|95.0|6.9538|11.9429||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: TSQM-9 convenience score=baseline TSQM-9 convenience score+treatment+CGR+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as TSQM-9 is not measured at baseline for these patients.||11.9429|6.9538|<0.001
91505335|NCT02211131|182880860|OTHER||Treatment Difference|4.3||||0.594|TWO_SIDED|80.0|-6.9|15.3||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||An 80% approximate exact CI for between-arm differences in binary rate is calculated using Wilson's score method with continuity correction.|||15.3|-6.9|0.594
91750108|NCT02499900|183392585|SUPERIORITY||Mean Difference (Final Values)|-0.802||||0.208|TWO_SIDED|95.0|-2.05|0.4461||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.4461|-2.0500|0.208
91750109|NCT02499900|183392585|SUPERIORITY||Mean Difference (Final Values)|-0.231||||0.47|TWO_SIDED|95.0|-0.8588|0.3962||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Physical Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.3962|-0.8588|0.470
91750110|NCT02499900|183392585|SUPERIORITY||Mean Difference (Final Values)|-0.639||||0.043|TWO_SIDED|95.0|-1.2564|-0.0214||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Cognitive Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||-0.0214|-1.2564|0.043
91750111|NCT02499900|183392585|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.237|TWO_SIDED|95.0|-0.0672|0.2711||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Psychosocial Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.2711|-0.0672|0.237
91750112|NCT02499900|183392586|SUPERIORITY||Mean Difference (Final Values)|0.706||||0.287|TWO_SIDED|95.0|-0.5947|1.0074||0.05 level of significance|Repeated Measures ANCOVA|||Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.0074|-0.5947|0.287
91505336|NCT02211131|182880861|OTHER||Treatment Difference|14.4||||0.003|TWO_SIDED|80.0|7.4|21.6||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||80% exact CI for binary rate of each arm is calculated using the Clopper Pearson method.|||21.6|7.4|0.003
91505337|NCT02211131|182880866|OTHER||Hazard Ratio (HR)|0.54||||0.05|TWO_SIDED|80.0|0.36|0.81||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.81|0.36|0.050
91505338|NCT05664490|182880872|SUPERIORITY||Risk Ratio (RR)|0.88||||0.44|TWO_SIDED|95.0|0.64|1.22||The threshold for statistical significance is 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on PrEP adherence at Week 12|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.22|0.64|0.44
91505339|NCT05664490|182880873|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.71|1.42||The threshold for statistical significance was 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on reduced CMD symptoms at Week 12.|The reference category for the risk ratio presented is the Standard of Care Mental Health Services arm.|||1.42|0.71|0.99
91505340|NCT05664490|182880874|SUPERIORITY||Risk Ratio (RR)|1.4||||0.03|TWO_SIDED|95.0|1.03|1.89||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to estimate to assess the effect of our intervention on PrEP adherence at Week 4.|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.89|1.03|0.03
91505341|NCT05664490|182880875|SUPERIORITY||Risk Ratio (RR)|0.81||||0.37|TWO_SIDED|95.0|0.5|1.29||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to assess the effect of the intervention on common mental disorders at Week 4.|The Standard of Care Mental Health Services arm was the reference category.|||1.29|0.50|0.37
91505342|NCT01589445|182880880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.06|STANDARD_DEVIATION|39.47|<|0.161||95.0|-88.0|118.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TC||118|-88.0|<0.161
91505343|NCT01589445|182880880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.66|STANDARD_DEVIATION|143.22|<|0.913|TWO_SIDED|95.0|-397.0|976.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TG||976|-397.0|<0.913
91750113|NCT02499900|183392586|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.868|TWO_SIDED|95.0|-1.5179|1.7991||0.05 level of significance|Repeated Measures ANCOVA|||Anxiety subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.7991|-1.5179|0.868
91750114|NCT02499900|183392586|SUPERIORITY||Mean Difference (Final Values)|0.481||||0.544|TWO_SIDED|95.0|-1.0734|2.0348||0.05 level of significance|Repeated Measures ANCOVA|||Depression subscale estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||2.0348|-1.0734|0.544
91750115|NCT02499900|183392586|SUPERIORITY||Mean Difference (Final Values)|1.867||||0.014|TWO_SIDED|95.0|0.3843|3.3487||0.05 level of significance|Repeated Measures ANCOVA|||Behavioral Control subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||3.3487|0.3843|0.014
91750116|NCT02499900|183392586|SUPERIORITY||Mean Difference (Final Values)|-0.092||||0.919|TWO_SIDED|95.0|-1.8565|1.6728||0.05 level of significance|Repeated Measures ANCOVA|||MHI Positive Affect subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.6728|-1.8565|0.919
91750117|NCT02499900|183392587|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.851|TWO_SIDED|95.0|-0.6777|0.5592||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline BDI-II total score=baseline BDI-II total score+treatment+visit+country/geographic region +treatment by visit interaction.||0.5592|-0.6777|0.851
91750118|NCT01089023|183392608|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
91750119|NCT01089023|183392609|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
91750120|NCT03410797|183392612|OTHER|Due to small sample size, nonparametric Wilcoxon signed-rank tests were used to compare VHI-10 before and after therapy.|Median Difference (Net)|7.0||||0.0076|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Descriptive statistics characterized this patient perception measurement.||||.0076
91505344|NCT01589445|182880880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|9.59|<|0.322|TWO_SIDED|95.0|-35.0|19.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HDL||19.0|-35.0|<0.322
91505345|NCT01589445|182880880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.62|STANDARD_DEVIATION|32.05|<|0.21|TWO_SIDED|95.0|-113.8|76.2||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||LDL||76.2|-113.8|<0.210
91505346|NCT01589445|182880881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_DEVIATION|2.41|<|0.05|TWO_SIDED|95.0|-7.9|8.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)|ANOVA||The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).|Change from Baseline in FSG at 3rd month||8.0|-7.9|<0.05
91505347|NCT01589445|182880882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_DEVIATION|1.07|>|0.05|TWO_SIDED|95.0|-4.4|2.4||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||2.4|-4.4|>0.05
91505348|NCT01589445|182880883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED|95.0|-0.4|0.27||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||0.27|-0.40|<0.001
91750121|NCT03410797|183392613|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Final Values)|-1.53||||0.0329|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0329
91750122|NCT03410797|183392614|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|15.39||||0.0164|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0164
91750123|NCT03410797|183392615|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-52.0||||0.1141|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1141
91750124|NCT03410797|183392616|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-1.7||||0.3329|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3329
91750125|NCT01185964|183392618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.0615|TWO_SIDED|95.0|0.442|1.021|||Log Rank|||||1.021|0.442|0.0615
91750126|NCT01185964|183392621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.463||||0.0003|TWO_SIDED|95.0|0.301|0.71|||Log Rank|||||0.710|0.301|0.0003
91750127|NCT05894538|183392629|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
91750128|NCT05894538|183392630|SUPERIORITY|Due to the low event rate, a posterior probability was not estimated.|Hazard Ratio (HR)|3.57|||||TWO_SIDED|95.0|0.74|17.18|||||Low event rate precluded covariate adjustment.|||17.18|0.74|
91750129|NCT05894538|183392633|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.45|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.45|0.60|
91750130|NCT05894538|183392637|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.96|0.61|
91750131|NCT05894538|183392637|OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||0.85|0.49|
91750132|NCT05894538|183392637|OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||0.92|0.52|
91750133|NCT05894538|183392637|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.72|
91505349|NCT01589445|182880883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_DEVIATION|4.25|<|0.004|TWO_SIDED|95.0|-14.12|15.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA IR||15.52|-14.12|<0.004
91505350|NCT01589445|182880884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.79|STANDARD_DEVIATION|84.46|<|0.808|TWO_SIDED|95.0|-346.4|328.1||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA B||328.10|-346.40|<0.808
91505351|NCT01589445|182880884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.53|STANDARD_DEVIATION|54.0|<|0.025|TWO_SIDED|95.0|-148.7|180.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA S||180|-148.70|<0.025
91750134|NCT05894538|183392638|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|1.03|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.56|1.03|
91750135|NCT05894538|183392638|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|1.00|
91505352|NCT01589445|182880885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|STANDARD_DEVIATION|10.2|<|0.039|TWO_SIDED|95.0|-27.04|26.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||FSI||26.52|-27.04|<0.039
91505353|NCT00481195|182880905|SUPERIORITY_OR_OTHER|||||||0.0439||95.0|||||ANOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.||||0.0439
91505354|NCT00481195|182880906|SUPERIORITY_OR_OTHER|||||||0.0795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0795
91750136|NCT05894538|183392638|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.35|0.87|
91750137|NCT05894538|183392638|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.86|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.32|0.86|
91750138|NCT05894538|183392639|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.26|0.81|
91750139|NCT05894538|183392639|OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.0|1.66|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.66|1.00|
91750140|NCT05894538|183392639|OTHER||Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|1.15|2.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||2.02|1.15|
91750141|NCT05894538|183392639|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.47|0.86|
91750142|NCT05894538|183392640|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.76|
91750143|NCT05894538|183392640|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.30|0.75|
91750144|NCT05894538|183392640|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.25|0.72|
91750145|NCT05894538|183392640|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.75|
91750146|NCT05894538|183392641|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.84|
91750147|NCT05894538|183392641|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.87|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.43|0.87|
91750148|NCT05894538|183392641|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.91|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.55|0.91|
91750149|NCT05894538|183392641|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.75|
91505355|NCT00481195|182880907|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0272
91750150|NCT05894538|183392642|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.20|0.79|
91750151|NCT05894538|183392642|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.02|0.63|
91750152|NCT05894538|183392642|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.69|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.69|
91750153|NCT05894538|183392642|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.35|0.84|
91505356|NCT00481195|182880908|SUPERIORITY_OR_OTHER|||||||0.0802||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0802
91505357|NCT00481195|182880909|SUPERIORITY_OR_OTHER|||||||0.2407||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2407
91750154|NCT05894538|183392643|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.19|0.78|
91750155|NCT05894538|183392643|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.92|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.39|0.92|
91750156|NCT05894538|183392643|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.91|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.36|0.91|
91750157|NCT05894538|183392643|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.82|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.82|
91750158|NCT05894538|183392644|SUPERIORITY||Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.39|0.32|||||The interval is a highest-density credible interval.|||0.32|-0.39|
91505358|NCT00481195|182880910|SUPERIORITY_OR_OTHER|||||||0.0502||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0502
91750159|NCT04962230|183392647|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|specify in comments|56.82||||0.05|TWO_SIDED|90.0|47.04|68.62|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||68.62|47.04|0.05
91750160|NCT04962230|183392648|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.5||||0.05|TWO_SIDED|90.0|33.77|58.65|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.65|33.77|0.05
91750161|NCT04962230|183392649|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|25.59||||0.05|TWO_SIDED|90.0|18.76|34.91|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||34.91|18.76|0.05
91505359|NCT00481195|182880911|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0612
91505360|NCT00481195|182880912|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.1980
91505361|NCT00481195|182880913|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.8960
91505362|NCT00481195|182880914|SUPERIORITY_OR_OTHER|||||||0.2575||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.2575
91532116|NCT07083843|182940561|SUPERIORITY|A superiority analysis was performed to compare depression and anxiety scores between the intervention and control groups.|Mean Difference (Final Values)|2.192|STANDARD_DEVIATION|2.8||0.05|TWO_SIDED|95.0|0.986|3.238|||paired sample T-test.|degree of freedom= 25||data were processed and analyzed using the SPSS software, version 22.0. The descriptive statistics were calculated, including frequencies and percentages for categorical data, and means and standard deviations for numerical variables. A paired t-test was used to assess the change in the psychological level before and after the intervention program. All hypothesis testing was done at the 5% level of significance||3.238|0.986|0.05
91750162|NCT04962230|183392650|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|16.57||||0.05|TWO_SIDED|90.0|13.32|20.6|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||20.60|13.32|0.05
91750163|NCT04962230|183392656|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.59||||0.05|TWO_SIDED|90.0|33.99|58.5|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.50|33.99|0.05
91750164|NCT04962230|183392661|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|12.92||||0.05|TWO_SIDED|90.0|9.28|17.99|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||17.99|9.28|0.05
91750165|NCT02210832|183392706|SUPERIORITY|38.27% vs. 9.09%|||||<|0.001||||||p value is not adjusted for multiple comparisons. A priori threshold for significance was P \< 0.05.|Chi-squared|chi square test statistic = 20.23, df = 1||Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.||||<0.001
91750166|NCT02210832|183392707|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||||||<0.05
91750167|NCT02210832|183392707|SUPERIORITY|||||||0.003||||||chi square test statistic = 21.93, df=7|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Trial condition by assessment time interaction||||0.003
91505363|NCT00481195|182880915|SUPERIORITY_OR_OTHER|||||||0.3129||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.3129
91505364|NCT00481195|182880916|SUPERIORITY_OR_OTHER|||||||0.1565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1565
91505365|NCT00481195|182880917|SUPERIORITY_OR_OTHER|||||||0.6737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6737
91505366|NCT00481195|182880918|SUPERIORITY_OR_OTHER|||||||0.2249||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2249
91505367|NCT00481195|182880919|SUPERIORITY_OR_OTHER|||||||0.0862||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0862
91505368|NCT00481195|182880920|SUPERIORITY_OR_OTHER|||||||0.9281||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9281
91750168|NCT02210832|183392708|SUPERIORITY|||||||0.48||||||chi square test statistic = 9.52, df = 10|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Interaction of trial condition and time||||0.48
91750169|NCT02210832|183392709|SUPERIORITY||||||<|0.0001||||||chi square test statistic = 33.51, df = 2|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Examining main effect of treatment condition.||||<0.0001
91750170|NCT02210832|183392709|SUPERIORITY|||||||0.89||||||chi square test statistic = 5.00, df = 10.|Mixed Models Analysis|||Testing interaction of treatment condition and assessment time||||0.89
91505369|NCT00481195|182880921|SUPERIORITY_OR_OTHER|||||||0.4428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.4428
91505370|NCT00481195|182880922|SUPERIORITY_OR_OTHER|||||||0.0965||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0965
91505371|NCT00481195|182880923|SUPERIORITY_OR_OTHER|||||||0.5389||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5389
91505372|NCT00481195|182880924|SUPERIORITY_OR_OTHER|||||||0.0793||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0793
91532117|NCT04213846|182940565|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.94||||0.34|TWO_SIDED|95.0|0.81|1.07|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.07|0.81|0.34
91532118|NCT04213846|182940565|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.09||||0.37|TWO_SIDED|95.0|0.91|1.3|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.30|0.91|0.37
91532119|NCT04213846|182940565|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.02||||0.8|TWO_SIDED|95.0|0.85|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.85|0.80
91750171|NCT02210832|183392710|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
91750172|NCT02210832|183392711|SUPERIORITY||||||<|0.001||||||F\[7,922\]=3.62|ANCOVA|Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.||Examine interaction of treatment condition and assessment time.||||<0.001
91750173|NCT02210832|183392711|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
91750174|NCT02210832|183392712|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||0.009
91750175|NCT02210832|183392713|SUPERIORITY|||||||0.01|||||||Regression, Logistic|Method is logistic regression adjusted for covariates.||||||0.01
91750176|NCT02210832|183392714|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91750177|NCT02210832|183392715|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91750178|NCT02210832|183392717|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91750179|NCT02210832|183392721|SUPERIORITY|||||||0.006|||||||ANCOVA|All comparisons adjusted for infant gestational age at time of delivery.||||||0.006
91505373|NCT00481195|182880925|SUPERIORITY_OR_OTHER|||||||0.3814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3814
91505374|NCT00481195|182880926|SUPERIORITY_OR_OTHER|||||||0.8099||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.8099
91505375|NCT00481195|182880927|SUPERIORITY_OR_OTHER|||||||0.0968||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0968
91505376|NCT00481195|182880928|SUPERIORITY_OR_OTHER|||||||0.1605||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1605
91505377|NCT00481195|182880929|SUPERIORITY_OR_OTHER|||||||0.1869||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1869
91750180|NCT03710876|183392751|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.284|TWO_SIDED|95.0|0.43|1.59||1-sided|Log Rank|||||1.59|0.43|0.2840
91532120|NCT04213846|182940566|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|1.02||||0.75|TWO_SIDED|95.0|0.88|1.2|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.88|0.75
91750181|NCT03710876|183392753|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-17.3|24.3||2-sided|Fisher Exact||Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||24.3|-17.3|1.0000
91750182|NCT03710876|183392754|SUPERIORITY||Risk Difference (RD)|2.2||||1|TWO_SIDED|95.0|-25.2|29.2|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||29.2|-25.2|1.0000
91750183|NCT03710876|183392755|SUPERIORITY||Risk Difference (RD)|-7.6||||0.7665|TWO_SIDED|95.0|-34.9|20.3|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||20.3|-34.9|0.7665
91750184|NCT03710876|183392756|SUPERIORITY||Risk Difference (RD)|-4.4||||0.7537|TWO_SIDED|95.0|-31.7|23.0||2-sided.|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||23.0|-31.7|0.7537
91750185|NCT03710876|183392757|SUPERIORITY||Risk Difference (RD)|18.4||||0.1855|TWO_SIDED|95.0|-8.8|45.6||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||45.6|-8.8|0.1855
91505378|NCT00481195|182880930|SUPERIORITY_OR_OTHER|||||||0.0817||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0817
91505379|NCT00481195|182880931|SUPERIORITY_OR_OTHER|||||||0.3712||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3712
91505380|NCT00481195|182880932|SUPERIORITY_OR_OTHER|||||||0.5427||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5427
91750186|NCT03710876|183392758|SUPERIORITY||Risk Difference (RD)|12.2||||0.357|TWO_SIDED|95.0|-13.8|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-13.8|0.3570
91750187|NCT03710876|183392759|SUPERIORITY||Risk Difference (RD)|13.5||||0.2856|TWO_SIDED|95.0|-11.3|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-11.3|0.2856
91750188|NCT03710876|183392760|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
91750189|NCT03710876|183392761|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
91750190|NCT01460719|183392795|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the GMFR is \>1.0.|||||<|0.001|||||||Single longitudinal regression model|Adjustments made for pre-vaccination values||||||<0.001
91750191|NCT01151761|183392803|SUPERIORITY_OR_OTHER||months|8.5|||||TWO_SIDED|95.0|7.0|10.0|||||There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.|The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.||10|7|
91750192|NCT01151761|183392808|SUPERIORITY_OR_OTHER||proportion of participants|0.0|||||TWO_SIDED||||||||None of the two patients who participated had a local recurrence before they died.|||||
91505381|NCT00481195|182880933|SUPERIORITY_OR_OTHER|||||||0.3463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3463
91505382|NCT00481195|182880934|SUPERIORITY_OR_OTHER|||||||0.273||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2730
91505383|NCT00481195|182880935|SUPERIORITY_OR_OTHER|||||||0.7791||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.7791
91750193|NCT01007123|183392822|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|0.0|||||ANCOVA|||||||<0.2
91750194|NCT01007123|183392822|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|0.0|||||ANCOVA|||||||0.002
91750195|NCT01007123|183392822|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
91750196|NCT01007123|183392823|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
91750197|NCT01007123|183392823|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|0.0|||||Fisher Exact|||||||0.008
91505384|NCT00481195|182880936|SUPERIORITY_OR_OTHER|||||||0.9007||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9007
91505385|NCT00481195|182880937|SUPERIORITY_OR_OTHER|||||||0.6431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6431
91750198|NCT01007123|183392823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||Fisher Exact|||||||<0.001
91750199|NCT01007123|183392824|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|0.0|||||Fisher Exact|||||||0.06
91750200|NCT01007123|183392824|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
91750201|NCT01007123|183392824|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|0.0|||||Fisher Exact|||||||0.04
91750202|NCT01007123|183392825|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|0.0|||||ANCOVA|||||||0.44
91750203|NCT01007123|183392825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
91750204|NCT01007123|183392825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
91750205|NCT01007123|183392826|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||0.01
91750206|NCT01007123|183392826|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||<0.05
91750207|NCT01007123|183392827|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|0.0|||||ANCOVA|||||||0.17
91750208|NCT01007123|183392827|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
91750209|NCT01007123|183392827|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
91750210|NCT02838901|183392828|OTHER|This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.||||||0.058||||||The p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.||||0.058
91750211|NCT02838901|183392829|OTHER|This was a descriptive analysis and was under the goal of assessing safety of the intervention.||||||1|||||||Fisher Exact|||Null hypothesis was assumed, no power calculation was done since this was a pilot study.||||1.00
91750212|NCT02838901|183392830|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.||||0.0003
91750213|NCT02838901|183392831|OTHER|This was a descriptive analysis for a pilot study, and no power calculations were performed.||||||0.1023|||||||Wilcoxon (Mann-Whitney)|||||||0.1023
91750214|NCT02838901|183392832|OTHER|This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||||||.9581
91750215|NCT02838901|183392832|OTHER|||||||0.6678|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.||||.6678
91750216|NCT02838901|183392834|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91750217|NCT02838901|183392834|OTHER|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
91750218|NCT02838901|183392835|OTHER|||||||0.889|||||||Wilcoxon (Mann-Whitney)|||||||.889
91750219|NCT02838901|183392835|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
91750220|NCT02838901|183392836|OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
91750221|NCT02838901|183392837|OTHER|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
91750222|NCT02838901|183392838|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||||||0.135
91750223|NCT02838901|183392839|OTHER|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||||||0.185
91505386|NCT00481195|182880938|SUPERIORITY_OR_OTHER|||||||0.6631||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder.||||||0.6631
91505387|NCT00481195|182880939|SUPERIORITY_OR_OTHER|||||||0.9768||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.9768
91750224|NCT04699032|183392919|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% confidence intervals (CIs) were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.62|||||TWO_SIDED|90.0|0.423|0.909||||||||0.909|0.423|
91750225|NCT04699032|183392920|OTHER|ANOVA was used to compare the natural log transformed AUCinf for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% CIs were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.694|||||TWO_SIDED|90.0|0.458|1.05||||||||1.050|0.458|
91750226|NCT03022097|183392923|SUPERIORITY||Least squares mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.06|0.124||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.124|0.060|<0.001
91750227|NCT03022097|183392924|SUPERIORITY||Least squares mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.053|0.117||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.117|0.053|<0.001
91505388|NCT00481195|182880940|SUPERIORITY_OR_OTHER|||||||0.9873||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment fro bipolar disorder||||||0.9873
91505389|NCT00481195|182880941|SUPERIORITY_OR_OTHER|||||||0.4567||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4567
91505390|NCT00481195|182880942|SUPERIORITY_OR_OTHER|||||||0.6475||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.6475
91505391|NCT00481195|182880943|SUPERIORITY_OR_OTHER|||||||0.5066||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.5066
91505392|NCT00481195|182880944|SUPERIORITY_OR_OTHER|||||||0.4438||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4438
91505393|NCT02932904|182880945|SUPERIORITY||Least square (LS) Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.04||0.009|TWO_SIDED|95.0|0.69|4.78||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||4.78|0.69|0.009
91505394|NCT02932904|182880945|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.017||0.303|TWO_SIDED|95.0|-0.95|3.05||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.05|-0.95|0.303
91505395|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.627||0.072|TWO_SIDED|95.0|-0.1|2.37|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.37|-0.10|0.072
91505396|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|1.29|STANDARD_ERROR_OF_MEAN|0.612||0.035|TWO_SIDED|95.0|0.09|2.5|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.50|0.09|0.035
91505397|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.846||0.149|TWO_SIDED|95.0|-0.44|2.89|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.89|-0.44|0.149
91505398|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.828||0.303|TWO_SIDED|95.0|-0.78|2.48|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.48|-0.78|0.303
91505399|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.906||0.028|TWO_SIDED|95.0|0.22|3.78|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.78|0.22|0.028
91505400|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.886||0.645|TWO_SIDED|95.0|-1.33|2.15|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.15|-1.33|0.645
91505401|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.943||0.043|TWO_SIDED|95.0|0.06|3.77|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.77|0.06|0.043
91505402|NCT02932904|182880946|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.923||0.465|TWO_SIDED|95.0|-1.14|2.49|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.49|-1.14|0.465
91505403|NCT02932904|182880947|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.616||0.009|TWO_SIDED|95.0|-2.84|-0.41|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.41|-2.84|0.009
91505404|NCT02932904|182880947|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.834||0.123|TWO_SIDED|95.0|-2.93|0.35|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.35|-2.93|0.123
91505405|NCT02932904|182880947|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.892||0.039|TWO_SIDED|95.0|-3.61|-0.1|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.10|-3.61|0.039
91505406|NCT02932904|182880947|SUPERIORITY||LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.929||0.008|TWO_SIDED|95.0|-4.32|-0.66|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.66|-4.32|0.008
91505407|NCT02932904|182880947|SUPERIORITY||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|1.024||0.007|TWO_SIDED|95.0|-4.78|-0.75|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.75|-4.78|0.007
91505408|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.612||0.419|TWO_SIDED|95.0|-1.7|0.71|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.71|-1.70|0.419
91505409|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.6||0.581|TWO_SIDED|95.0|-1.51|0.85|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.85|-1.51|0.581
91505410|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.828||0.938|TWO_SIDED|95.0|-1.69|1.56|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.56|-1.69|0.938
91505411|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.814||0.592|TWO_SIDED|95.0|-2.04|1.17|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.17|-2.04|0.592
91505412|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.886||0.87|TWO_SIDED|95.0|-1.6|1.89|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.89|-1.60|0.870
91750228|NCT03022097|183392925|SUPERIORITY||Least squares mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.103|0.166||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.166|0.103|<0.001
91750229|NCT03022097|183392926|SUPERIORITY||Least squares mean difference|0.217|STANDARD_ERROR_OF_MEAN|0.017|<|0.001|TWO_SIDED|95.0|0.184|0.25||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.250|0.184|<0.001
91750230|NCT03022097|183392927|SUPERIORITY||Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.2|1.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.3|0.2|0.005
91750231|NCT03022097|183392927|SUPERIORITY||Least squares mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.132|TWO_SIDED|95.0|-0.1|1.0||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.0|-0.1|0.132
91750232|NCT03022097|183392928|SUPERIORITY||Least squares mean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003|TWO_SIDED|95.0|-6.7|-1.4||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-1.4|-6.7|0.003
91750233|NCT03022097|183392928|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.3||0.031|TWO_SIDED|95.0|-5.5|-0.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-0.3|-5.5|0.031
91750234|NCT00623545|183392929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|185.0|STANDARD_DEVIATION|240.0||0.001|TWO_SIDED|95.0||||The a prior threshold for statistical significance was p\< 0.05|ANOVA||units are kcal/d|Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg-1 divided by 84 days or 185 kcal·day-1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day-1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.||||0.001
91750235|NCT00623545|183392929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91750236|NCT00623545|183392930|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.||||< 0.05
91505413|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.871||0.098|TWO_SIDED|95.0|-3.16|0.27|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.27|-3.16|0.098
91505414|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.923||0.532|TWO_SIDED|95.0|-2.39|1.24|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.24|-2.39|0.532
91750237|NCT00623545|183392930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91750238|NCT00445848|183392931|OTHER||proportion of participants|0.78|||||TWO_SIDED|95.0|0.67|0.85||||||The overall survival rate at year 1 was estimated using Kaplan-Meier.||0.85|0.67|
91750239|NCT00445848|183392931|OTHER||proportion of participants|0.57|||||TWO_SIDED|95.0|0.46|0.67||||||The overall survival rate at year 2 was estimated using Kaplan-Meier.||0.67|0.46|
91750240|NCT00445848|183392931|OTHER||proportion of participants|0.43|||||TWO_SIDED|95.0|0.32|0.53||||||The overall survival rate at year 3 was estimated using Kaplan-Meier.||0.53|0.32|
91750241|NCT00855933|183392960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.066||0.126|TWO_SIDED|95.0|-0.03|0.24||a priori threshold for statistical significance = 0.05|ANCOVA||2-sided with the significance level set at 5%|||0.24|-0.03|0.126
91750242|NCT05463744|183392961|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.052|||||TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|
91750243|NCT05463744|183392962|SUPERIORITY||LS Mean Difference|0.052||||0.432|TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|0.432
91750244|NCT05463744|183392963|SUPERIORITY||LS Mean Difference|-0.31||||0.751|TWO_SIDED|95.0|-2.22|1.6|||ANCOVA|||||1.60|-2.22|0.751
91750245|NCT05463744|183392964|SUPERIORITY||Relative Rate|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Negative binomial model|||||1.31|0.79|0.900
91750246|NCT05463744|183392965|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0682|||TWO_SIDED|95.0|-0.11|0.157|||ANCOVA|||||0.157|-0.110|
91750247|NCT05463744|183392966|SUPERIORITY||LS Mean Difference|-1.22||||0.697|TWO_SIDED|95.0|-7.38|4.93|||ANCOVA|||Week 26||4.93|-7.38|0.697
91750248|NCT05463744|183392966|SUPERIORITY||LS Mean Difference|-4.84||||0.163|TWO_SIDED|95.0|-11.64|1.96|||ANCOVA|||Week 52||1.96|-11.64|0.163
91505415|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.907||0.046|TWO_SIDED|95.0|-3.6|-0.03|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.03|-3.60|0.046
91505416|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.018||0.977|TWO_SIDED|95.0|-2.03|1.97|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.97|-2.03|0.977
91505417|NCT02932904|182880948|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.0||0.087|TWO_SIDED|95.0|-3.68|0.25|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.25|-3.68|0.087
91505418|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.515|TWO_SIDED|95.0|0.037|5.201|||Regression, Logistic|||Week 1||5.201|0.037|0.515
91505419|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.59||||0.677|TWO_SIDED|95.0|0.049|7.051|||Regression, Logistic|||Week 1||7.051|0.049|0.677
91750249|NCT05463744|183392967|SUPERIORITY||LS Mean Difference|0.02||||0.939|TWO_SIDED|95.0|-0.61|0.66|||Mixed Models Analysis|||Week 23 to Week 26||0.66|-0.61|0.939
91750250|NCT05463744|183392967|SUPERIORITY||LS Mean Difference|0.52||||0.116|TWO_SIDED|95.0|-0.13|1.17|||Mixed Models Analysis|||Week 49 to Week 52||1.17|-0.13|0.116
91505420|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.47||||0.72|TWO_SIDED|95.0|0.181|11.912|||Regression, Logistic|||Week 1||11.912|0.181|0.720
91505421|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.65||||0.732|TWO_SIDED|95.0|0.053|7.861|||Regression, Logistic|||Week 1||7.861|0.053|0.732
91505422|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.87||||0.913|TWO_SIDED|95.0|0.066|11.303|||Regression, Logistic|||Week 1||11.303|0.066|0.913
91532121|NCT04213846|182940566|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.04||||0.72|TWO_SIDED|95.0|0.86|1.25|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.25|0.86|0.72
91750251|NCT05463744|183392968|SUPERIORITY||LS Mean Difference|0.54||||0.61|TWO_SIDED|95.0|-1.54|2.62|||ANCOVA|||||2.62|-1.54|0.610
91750252|NCT05463744|183392969|SUPERIORITY||LS Mean Difference|-8.96||||0.155|TWO_SIDED|95.0|-21.3|3.38|||Mixed Models Analysis|||Week 26||3.38|-21.30|0.155
91750253|NCT05463744|183392969|SUPERIORITY||LS Mean Difference|-6.88||||0.278|TWO_SIDED|95.0|-19.31|5.55|||Mixed Models Analysis|||Week 52||5.55|-19.31|0.278
91750254|NCT05463744|183392970|SUPERIORITY||LS Mean Difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.52|-2.03|||Mixed Models Analysis|||Week 26||-2.03|-5.52|<0.001
91750255|NCT05463744|183392970|SUPERIORITY||LS Mean Difference|-3.49|||<|0.001|TWO_SIDED|95.0|-5.26|-1.71|||Mixed Models Analysis|||Week 52||-1.71|-5.26|<0.001
91750256|NCT05463744|183392971|SUPERIORITY||LS Mean Difference|-39.28|||<|0.001|TWO_SIDED|95.0|-57.59|-20.98|||Mixed Models Analysis|||Week 26||-20.98|-57.59|<0.001
91750257|NCT05463744|183392971|SUPERIORITY||LS Mean Difference|-35.94|||<|0.001|TWO_SIDED|95.0|-54.44|-17.43|||Mixed Models Analysis|||Week 52||-17.43|-54.44|<0.001
91750258|NCT05463744|183392972|SUPERIORITY||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|1.32|5.06|||Mixed Models Analysis|||Week 26||5.06|1.32|<0.001
91750259|NCT05463744|183392972|SUPERIORITY||LS Mean Difference|2.8||||0.004|TWO_SIDED|95.0|0.91|4.7|||Mixed Models Analysis|||Week 52||4.70|0.91|0.004
91750260|NCT05463744|183392973|SUPERIORITY||Relative Rate|1.21||||0.016|TWO_SIDED|95.0|1.04|1.41|||Negative binomial model|||||1.41|1.04|0.016
91750261|NCT05463744|183392974|SUPERIORITY||LS Mean Difference|0.086||||0.702|TWO_SIDED|95.0|-0.35|0.53|||Mixed Models Analysis|||Week 26||0.53|-0.35|0.702
91750262|NCT05463744|183392974|SUPERIORITY||LS Mean Difference|0.12||||0.609|TWO_SIDED|95.0|-0.33|0.56|||Mixed Models Analysis|||Week 52||0.56|-0.33|0.609
91750263|NCT05463744|183392975|SUPERIORITY||LS Mean Difference|0.03||||0.681|TWO_SIDED|95.0|-0.13|0.19|||ANCOVA|||Week 23 to Week 26||0.19|-0.13|0.681
91505423|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.37||||0.164|TWO_SIDED|95.0|0.09|1.507|||Regression, Logistic|||Week 2||1.507|0.090|0.164
91750264|NCT05463744|183392975|SUPERIORITY||LS Mean Difference|0.1||||0.182|TWO_SIDED|95.0|-0.05|0.24|||ANCOVA|||Week 49 to Week 52||0.24|-0.05|0.182
91750265|NCT05463744|183392976|SUPERIORITY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-2.06|2.05|||ANCOVA|||Week 23 to Week 26||2.05|-2.06|0.999
91750266|NCT05463744|183392977|SUPERIORITY||LS Mean Difference|-0.83||||0.468|TWO_SIDED|95.0|-3.06|1.41|||ANCOVA|||||1.41|-3.06|0.468
91750267|NCT05463744|183392978|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91750268|NCT05463744|183392979|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91505424|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.25||||0.098|TWO_SIDED|95.0|0.05|1.287|||Regression, Logistic|||Week 2||1.287|0.050|0.098
91505425|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.2||||0.758|TWO_SIDED|95.0|0.383|3.731|||Regression, Logistic|||Week 2||3.731|0.383|0.758
91505426|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.256|TWO_SIDED|95.0|0.107|1.814|||Regression, Logistic|||Week 2||1.814|0.107|0.256
91505427|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.3||||0.154|TWO_SIDED|95.0|0.059|1.561|||Regression, Logistic|||Week 2||1.561|0.059|0.154
91505428|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.36||||0.16|TWO_SIDED|95.0|0.087|1.497|||Regression, Logistic|||Week 3||1.497|0.087|0.160
91505429|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.744|TWO_SIDED|95.0|0.252|2.679|||Regression, Logistic|||Week 3||2.679|0.252|0.744
91505430|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.43||||0.194|TWO_SIDED|95.0|0.636|9.317|||Regression, Logistic|||Week 3||9.317|0.636|0.194
91505431|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.88||||0.871|TWO_SIDED|95.0|0.181|4.261|||Regression, Logistic|||Week 3||4.261|0.181|0.871
91505432|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.0||||0.329|TWO_SIDED|95.0|0.497|8.037|||Regression, Logistic|||Week 3||8.037|0.497|0.329
91505433|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.42||||0.187|TWO_SIDED|95.0|0.119|1.514|||Regression, Logistic|||Week 4||1.514|0.119|0.187
91505434|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.729|TWO_SIDED|95.0|0.273|2.476|||Regression, Logistic|||Week 4||2.476|0.273|0.729
91505435|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.71||||0.133|TWO_SIDED|95.0|0.739|9.917|||Regression, Logistic|||Week 4||9.917|0.739|0.133
91532122|NCT04213846|182940566|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.91|TWO_SIDED|95.0|0.85|1.21|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.21|0.85|0.91
91532123|NCT04213846|182940567|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||0.99|0.69|0.04
91505436|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.266|4.961|||Regression, Logistic|||Week 4||4.961|0.266|0.852
91505437|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.23||||0.24|TWO_SIDED|95.0|0.585|8.472|||Regression, Logistic|||Week 4||8.472|0.585|0.240
91750269|NCT05463744|183392980|SUPERIORITY||LS Mean Difference|0.43||||0.27|TWO_SIDED|95.0|-0.33|1.19|||Mixed Models Analysis|||Physical Component Score: Week 26||1.19|-0.33|0.270
91505438|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.55||||0.317|TWO_SIDED|95.0|0.166|1.789|||Regression, Logistic|||Week 5||1.789|0.166|0.317
91750270|NCT05463744|183392980|SUPERIORITY||LS Mean Difference|0.73||||0.05|TWO_SIDED|95.0|0.0|1.45|||Mixed Models Analysis|||Physical Component Score: Week 52||1.45|0.000|0.050
91750271|NCT05463744|183392980|SUPERIORITY||LS Mean Difference|0.22||||0.71|TWO_SIDED|95.0|-0.94|1.38|||Mixed Models Analysis|||Mental Component Score: Week 26||1.38|-0.94|0.710
91750272|NCT05463744|183392980|SUPERIORITY||LS Mean Difference|0.45||||0.447|TWO_SIDED|95.0|-0.71|1.61|||Mixed Models Analysis|||Mental Component Score: Week 52||1.61|-0.71|0.447
91750273|NCT03385265|183393026|SUPERIORITY||partial eta squared|0.02|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91750274|NCT03385265|183393027|SUPERIORITY||partial eta squared|0.12|||||TWO_SIDED||||||repeated measures ANOVA|CESD-R = within subject variable; group = between subject variable||||||
91750275|NCT03385265|183393028|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91750276|NCT03385265|183393029|SUPERIORITY||partial eta squared|0.06|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91505439|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.79|TWO_SIDED|95.0|0.41|3.233|||Regression, Logistic|||Week 5||3.233|0.410|0.790
91505440|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|3.64||||0.073|TWO_SIDED|95.0|0.888|14.911|||Regression, Logistic|||Week 5||14.911|0.888|0.073
91505441|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.98||||0.371|TWO_SIDED|95.0|0.442|8.902|||Regression, Logistic|||Week 5||8.902|0.442|0.371
91750277|NCT03385265|183393030|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91505442|NCT02932904|182880949|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|4.19||||0.046|TWO_SIDED|95.0|1.027|17.063|||Regression, Logistic|||Week 5||17.063|1.027|0.046
91505443|NCT02932904|182880952|SUPERIORITY||LS Mean Difference|3.38|STANDARD_ERROR_OF_MEAN|1.082||0.002|TWO_SIDED|95.0|1.25|5.51||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.51|1.25|0.002
91750278|NCT03385265|183393031|SUPERIORITY||partial eta squared|0.04|||<|0.05|TWO_SIDED||||||repeated measures ANOVA|||||||<0.05
91750279|NCT03385265|183393032|SUPERIORITY||partial eta squared|0.24|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91750280|NCT03385265|183393033|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91750281|NCT03385265|183393034|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91750282|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-2.12||||0.956|TWO_SIDED|95.0|-79.67|75.42|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1||75.42|-79.67|0.956
91750283|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.995|TWO_SIDED|95.0|-105.41|106.07|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14||106.07|-105.41|0.995
91750284|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-59.35||||0.366|TWO_SIDED|95.0|-191.15|72.45|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28||72.45|-191.15|0.366
91750285|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-100.02||||0.016|TWO_SIDED|95.0|-179.96|-20.08|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1||-20.08|-179.96|0.016
91750286|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-137.85||||0.014|TWO_SIDED|95.0|-245.28|-30.43|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14||-30.43|-245.28|0.014
91750287|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-229.04||||0.001|TWO_SIDED|95.0|-362.17|-95.91|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28||-95.91|-362.17|0.001
91750288|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-89.98||||0.025|TWO_SIDED|95.0|-167.62|-12.33|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1||-12.33|-167.62|0.025
91750289|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-222.02|||<|0.001|TWO_SIDED|95.0|-326.54|-117.51|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14||-117.51|-326.54|<0.001
91750290|NCT04465877|183393045|SUPERIORITY||Mean Difference (Final Values)|-248.82|||<|0.001|TWO_SIDED|95.0|-379.35|-118.28|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28||-118.28|-379.35|<0.001
91750291|NCT04346108|183393077|SUPERIORITY||Poisson Estimate|1.65|||||TWO_SIDED|95.0|0.73|3.15||||||||3.15|0.73|
91750292|NCT04346108|183393077|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
91750293|NCT04346108|183393077|SUPERIORITY||Poisson Estimate|2.48|||||TWO_SIDED|95.0|1.34|4.13||||||||4.13|1.34|
91750294|NCT04346108|183393078|SUPERIORITY||Poisson Estimate|2.6|||||TWO_SIDED|95.0|1.02|5.3||||||||5.30|1.02|
91750295|NCT04346108|183393078|SUPERIORITY||Poisson Estimate|9.82|||||TWO_SIDED|95.0|2.82|23.82||||||||23.82|2.82|
91750296|NCT04346108|183393078|SUPERIORITY||Poisson Estimate|2.87|||||TWO_SIDED|95.0|1.37|5.18||||||||5.18|1.37|
91750297|NCT04346108|183393079|SUPERIORITY||Poisson Estimate|4.01||||||95.0|1.46|8.54||||||||8.54|1.46|
91750298|NCT04346108|183393079|SUPERIORITY||Poisson Estimate|3.07|||||TWO_SIDED|95.0|0.37|10.74||||||||10.74|0.37|
91750299|NCT04346108|183393079|SUPERIORITY||Poisson Estimate|5.87|||||TWO_SIDED|95.0|2.32|11.93||||||||11.93|2.32|
91750300|NCT04346108|183393080|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
91750301|NCT04346108|183393080|SUPERIORITY||Poisson Estimate|0.13|||||TWO_SIDED|95.0|0.03|0.35||||||||0.35|0.03|
91750302|NCT04346108|183393080|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
91750303|NCT04346108|183393081|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
91750304|NCT04346108|183393081|SUPERIORITY||Poisson Estimate|1.04|||||TWO_SIDED|95.0|0.25|2.76||||||||2.76|0.25|
91750305|NCT04346108|183393082|SUPERIORITY||Poisson Estimate|1.18|||||TWO_SIDED|95.0|0.38|2.68||||||||2.68|0.38|
91750306|NCT04346108|183393082|SUPERIORITY||Poisson Estimate|2.35|||||TWO_SIDED|95.0|0.91|4.82||||||||4.82|0.91|
91505444|NCT02932904|182880952|SUPERIORITY||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|1.068||0.129|TWO_SIDED|95.0|-0.47|3.73||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.73|-0.47|0.129
91505445|NCT02932904|182880953|SUPERIORITY||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|1.078|<|0.001|TWO_SIDED|95.0|2.19|6.43||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||6.43|2.19|<0.001
91750307|NCT04346108|183393082|SUPERIORITY||Poisson Estimate|0.61|||||TWO_SIDED|95.0|0.07|2.15||||||||2.15|0.07|
91750308|NCT02275117|183393089|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|12.6||||0.033|TWO_SIDED|95.0|1.3|24.0|||Cochran-Mantel-Haenszel|||||24.0|1.3|0.0330
91750309|NCT02275117|183393089|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|10.7||||0.0715|TWO_SIDED|95.0|-0.5|21.8|||Cochran-Mantel-Haenszel|||||21.8|-0.5|0.0715
91750310|NCT02275117|183393089|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|7.5||||0.2013|TWO_SIDED|95.0|-3.5|18.5|||Cochran-Mantel-Haenszel|||||18.5|-3.5|0.2013
91750311|NCT02275117|183393089|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|6.1||||0.2938|TWO_SIDED|95.0|-4.6|16.9|||Cochran-Mantel-Haenszel|||||16.9|-4.6|0.2938
91750312|NCT01327274|183393111|OTHER|Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.||||||0.486|||||||Wilcoxon (Mann-Whitney)|||||||0.486
91750313|NCT00386477|183393113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.11||95.0|0.26|1.11|||Chi-squared, Corrected|||||1.11|0.26|0.11
91750314|NCT01081301|183393114|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
91750315|NCT01081301|183393115|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
91750316|NCT01081301|183393116|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures||Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
91750317|NCT01081301|183393117|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||>0.05
91750318|NCT01081301|183393118|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
91505446|NCT02932904|182880953|SUPERIORITY||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|1.072||0.005|TWO_SIDED|95.0|0.95|5.17||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.17|0.95|0.005
91505447|NCT02590939|182880975|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91505448|NCT02590939|182880976|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91505449|NCT02590939|182880977|SUPERIORITY|||||||0.666||||||Statistical significance threshold set to 0.05|Fisher Exact|||||||0.666
91505450|NCT02590939|182880978|SUPERIORITY|||||||0.026||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
91505451|NCT02590939|182880979|SUPERIORITY|||||||1||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||1
91505452|NCT02590939|182880980|SUPERIORITY|||||||0.037||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.037
91505453|NCT02590939|182880981|SUPERIORITY|||||||0.028||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.028
91505454|NCT02590939|182880982|SUPERIORITY|||||||0.062||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.062
91505455|NCT03706794|182880995|SUPERIORITY||Mann-Whitney U|43.0||||0.829|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.829
91750319|NCT01095653|183393122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.0975|<|0.0001|TWO_SIDED|95.0|-0.94|-0.56||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.56|-0.94|<0.0001
91505456|NCT03706794|182880996|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
91505457|NCT03706794|182880997|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
91505458|NCT03706794|182880998|SUPERIORITY||Mann-Whitney U|46.0||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
91750320|NCT01095653|183393122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.0962|<|0.0001|TWO_SIDED|95.0|-1.01|-0.63||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.63|-1.01|<0.0001
91505459|NCT03706794|182880999|SUPERIORITY||Mann-Whitney U|52.0||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.315
91505460|NCT00566150|182881017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.29
91505461|NCT00566150|182881018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.07
91505462|NCT00566150|182881019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Statistical significance was p\<0.05|Fisher Exact|Fisher's exact test was used to test for significance between groups.||Week 6||||.038
91505463|NCT00566150|182881020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups.||||0.79
91505464|NCT01527682|182881046|OTHER||Proportion|76.7|||||TWO_SIDED|95.0|64.1|89.4|||||||The statistical analysis was performed according to study design. Using a Fleming single stage design (A'Hern approach) setting the probability of erroneously concluding that the responders rate is greater than 35% at 5% (one-sided alpha=0.05) and the probability of correctly concluding that the responders rate is at least 50% at 80% (beta error = 0.20), the minimum number of responder eyes was set at 31 out of 68, since this result is associated with a lower limit of the 90% exact confidence interval of 35.2%.|89.4|64.1|
91505465|NCT03979638|182881050|SUPERIORITY||Estimated percent change|-10.8||||0.1424|TWO_SIDED|95.0|-23.5|4.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||4.0|-23.5|0.1424
91505466|NCT03979638|182881050|SUPERIORITY||Estimated percent change|-6.1||||0.4602|TWO_SIDED|95.0|-20.8|11.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||11.2|-20.8|0.4602
91505467|NCT03979638|182881050|SUPERIORITY||Estimated percent change|-7.8||||0.4181|TWO_SIDED|95.0|-24.4|12.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.5|-24.4|0.4181
91505468|NCT03979638|182881050|SUPERIORITY||Estimated percent change|-16.7||||0.0855|TWO_SIDED|95.0|-32.3|2.6|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||2.6|-32.3|0.0855
91505469|NCT03979638|182881051|SUPERIORITY||Estimated percent change|-20.3||||0.001|TWO_SIDED|95.0|-29.9|-9.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-9.5|-29.9|0.0010
91750321|NCT01095653|183393123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.7|STANDARD_ERROR_OF_MEAN|3.203|<|0.0001|TWO_SIDED|95.0|-34.0|-21.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-21.4|-34.0|<0.0001
91750322|NCT01095653|183393123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.2|STANDARD_ERROR_OF_MEAN|3.174|<|0.0001|TWO_SIDED|95.0|-40.4|-27.9||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-27.9|-40.4|<0.0001
91750323|NCT01095653|183393124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|6.5667|<|0.0001|TWO_SIDED|95.0|-60.8|-34.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-34.96|-60.80|<0.0001
91750324|NCT01095653|183393124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.0|STANDARD_ERROR_OF_MEAN|6.4489|<|0.0001|TWO_SIDED|95.0|-68.66|-43.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-43.28|-68.66|<0.0001
91750325|NCT01095653|183393125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3259|<|0.0001|TWO_SIDED|95.0|-2.01|-0.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.73|-2.01|<0.0001
91750326|NCT01095653|183393125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.3242|<|0.0001|TWO_SIDED|95.0|-2.62|-1.34||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.34|-2.62|<0.0001
91750327|NCT01095653|183393126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3|STANDARD_ERROR_OF_MEAN|5.238|<|0.0001|TWO_SIDED|95.0|11.1|31.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||31.6|11.1|<0.0001
91750328|NCT01095653|183393126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5|STANDARD_ERROR_OF_MEAN|5.022|<|0.0001|TWO_SIDED|95.0|18.6|38.3||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||38.3|18.6|<0.0001
91750329|NCT02836873|183393153|SUPERIORITY||Difference of LS Means|-0.28||||0.0026|TWO_SIDED|95.0|-0.46|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||This is a mixed-effects repeated measures analysis including region, screening anti-diabetic treatment regimen, baseline eGFR, treatment, visit, treatment-by-visit interaction and baseline HbA1c as a fixed effect covariate. Data from Weeks 6, 12, and 24 are used in the model.||-0.10|-0.46|0.0026
91505470|NCT03979638|182881051|SUPERIORITY||Estimated percent change|-17.7||||0.0186|TWO_SIDED|95.0|-29.9|-3.3|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.3|-29.9|0.0186
91505471|NCT03979638|182881051|SUPERIORITY||Estimated percent change|-19.4||||0.032|TWO_SIDED|95.0|-33.9|-1.9|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-1.9|-33.9|0.0320
91505472|NCT03979638|182881051|SUPERIORITY||Estimated percent change|-27.0||||0.0026|TWO_SIDED|95.0|-40.3|-10.8|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-10.8|-40.3|0.0026
91505473|NCT03979638|182881052|SUPERIORITY||Estimated percent change|-28.1||||0.0005|TWO_SIDED|95.0|-39.5|-14.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-14.5|-39.5|0.0005
91750330|NCT02836873|183393154|SUPERIORITY||Difference of LS Means|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.03|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-1.03|-2.50|< 0.0001
91750331|NCT02836873|183393155|SUPERIORITY||Difference of LS Means|-2.63||||0.2035|TWO_SIDED|95.0|-6.7|1.44|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||1.44|-6.70|0.2035
91750332|NCT02836873|183393156|SUPERIORITY||Difference of LS Means|-0.2||||0.1156|TWO_SIDED|95.0|-0.44|0.05|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||0.05|-0.44|0.1156
91750333|NCT02836873|183393157|SUPERIORITY||Difference of LS Means|-0.37||||0.0078|TWO_SIDED|95.0|-0.65|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-0.10|-0.65|0.0078
91750334|NCT02266277|183393158|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.3||||0.0001|TWO_SIDED|95.0|1.15|1.47||Adjusted for age, sex, race and utilization|Regression, Logistic|||||1.47|1.15|0.0001
91750335|NCT02266277|183393158|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.2||||0.0026|TWO_SIDED|95.0|1.07|1.36|||Regression, Logistic|||||1.36|1.07|.0026
91505474|NCT03979638|182881052|SUPERIORITY||Estimated percent change|-28.4||||0.0003|TWO_SIDED|95.0|-39.7|-15.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.0|-39.7|0.0003
91505475|NCT03979638|182881052|SUPERIORITY||Estimated percent change|-29.5||||0.0014|TWO_SIDED|95.0|-42.7|-13.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-13.2|-42.7|0.0014
91505476|NCT03979638|182881052|SUPERIORITY||Estimated percent change|-32.4||||0.0006|TWO_SIDED|95.0|-45.3|-16.4|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.4|-45.3|0.0006
91532124|NCT04213846|182940567|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.98||||0.84|TWO_SIDED|95.0|0.77|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.77|0.84
91750336|NCT02266277|183393158|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.16||||0.0206|TWO_SIDED|95.0|1.02|1.31|||Regression, Logistic|||||1.31|1.02|.0206
91505477|NCT02678676|182881078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.3444|TWO_SIDED|95.0|0.88|1.04||No adjustment to the p-value|Regression, Cox|||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.04|0.88|0.3444
91505478|NCT02678676|182881079|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.16|0.83|
91505479|NCT03200899|182881080|SUPERIORITY|||||||0.926|||||||ANCOVA|||||||0.926
91505480|NCT03200899|182881081|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.750
91505481|NCT03200899|182881082|SUPERIORITY|||||||0.129|||||||ANCOVA|||||||0.129
91505482|NCT03200899|182881083|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
91505483|NCT03200899|182881084|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||0.037
91505484|NCT03200899|182881085|SUPERIORITY|||||||0.297|||||||ANCOVA|||||||0.297
91505485|NCT03200899|182881086|SUPERIORITY|||||||0.293|||||||ANCOVA|||||||0.293
91505486|NCT03200899|182881087|SUPERIORITY|||||||0.045|||||||ANCOVA|||||||0.045
91505487|NCT04646499|182881090|SUPERIORITY|||||||0.34|||||||Sign test|||||||0.34
91505488|NCT04646499|182881091|SUPERIORITY|||||||0.024|||||||Sign test|||||||0.024
91505489|NCT04646499|182881092|SUPERIORITY|||||||0.083|||||||Sign test|||||||0.083
91505490|NCT04646499|182881093|SUPERIORITY|||||||0.049|||||||Sign test|||||||0.049
91505491|NCT04646499|182881094|SUPERIORITY|||||||0.31|||||||Sign test|||||||0.31
91505492|NCT01538862|182881107|SUPERIORITY|||||||0.82|||||||Regression, Linear|||||||0.82
91505493|NCT01400516|182881110|SUPERIORITY||Median Difference (Final Values)|9.5||||0.28|TWO_SIDED|||||A p-value \< 0.05 is considered statistically significant.|Linear mixed model||control-teriparatide|||||0.28
91505494|NCT01412866|182881118|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|df=1||||||0.08
91505495|NCT02496533|182881140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8|||<|0.001|TWO_SIDED|||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.001
91505496|NCT02496533|182881141|SUPERIORITY_OR_OTHER||||||<|0.02||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.02
91505497|NCT02496533|182881141|SUPERIORITY_OR_OTHER||||||<|0.09||||||No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.|ANOVA|||H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.09
91505498|NCT02496533|182881142|SUPERIORITY_OR_OTHER||||||<|0.009||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.009
91505499|NCT02496533|182881143|SUPERIORITY_OR_OTHER||||||<|0.45||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.45
91505500|NCT00502697|182881157|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.||||.64
91750337|NCT02266277|183393158|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.07||||0.233|TWO_SIDED|95.0|0.96|1.21|||Regression, Logistic|||||1.21|.96|.2330
91750338|NCT02266277|183393158|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio, log|1.12||||0.0579|TWO_SIDED|95.0|0.996|1.26|||Regression, Logistic|||||1.26|.996|.0579
91750339|NCT02266277|183393158|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.14|||Regression, Logistic|||||1.14|.86|.87
91750340|NCT02266277|183393159|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.31|||Regression, Logistic|||||1.31|.81|.82
91750341|NCT02266277|183393159|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio, log|0.9||||0.36|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.36
91750342|NCT02266277|183393159|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.89||||0.33|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.33
91505501|NCT00589108|182881198|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 2 years post-surgery.||||0.64
91505502|NCT00589108|182881198|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 5 years post-surgery.||||0.80
91505503|NCT00589108|182881199|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||P-value for the difference for the Knee Society Function Score between the three groups at 5 years post-surgery.||||0.06
91505504|NCT00589108|182881200|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||P-value for the difference for the Knee Society Pain Score between the three groups at 5 years post-surgery.||||0.87
91505505|NCT00589108|182881201|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 2 years post-surgery.||||0.44
91532125|NCT04213846|182940567|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|0.9||||0.34|TWO_SIDED|95.0|0.73|1.22|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.22|0.73|0.34
91532126|NCT04213846|182940568|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.98||||0.78|TWO_SIDED|95.0|0.82|1.16|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.16|0.82|0.78
91505506|NCT00589108|182881201|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 5 years post-surgery.||||0.08
91505507|NCT00589108|182881202|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||P-value for the difference between the percentage of knees surviving between the three groups at 5 years post-surgery.||||0.92
91513411|NCT02328326|182898540|SUPERIORITY||Mean Difference (Net)|-2.82||||0.18|TWO_SIDED|95.0|-7.0|1.35|||Regression, Linear|Model was adjusted for baseline value of SBP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.||1.35|-7.00|0.18
91532127|NCT04213846|182940568|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.9||||0.27|TWO_SIDED|95.0|0.75|1.08|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.75|0.27
91532128|NCT04213846|182940568|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.95|TWO_SIDED|95.0|0.84|1.2|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.84|0.95
91532129|NCT04213846|182940569|SUPERIORITY|Generalized linear model was estimated using a sample of N=346.|Count/Rate Ratio|0.98||||0.69|TWO_SIDED|95.0|0.89|1.08|||Generalized linear mixed model|Model controlled for sex, age, and college type (2-year vs. 4-year) and used a negative binomial error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.89|0.69
91532130|NCT05516342|182940589|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91750343|NCT02266277|183393159|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.87||||0.23|TWO_SIDED|95.0|0.69|1.09|||Regression, Logistic|||||1.09|.69|.23
91750344|NCT02266277|183393159|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.99||||0.96|TWO_SIDED|95.0|0.79|1.25|||Regression, Logistic|||||1.25|.79|.96
91750345|NCT02266277|183393159|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Logistic|||||1.31|.82|.76
91750346|NCT00884039|183393204|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
91750347|NCT01300819|183393206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.147|TWO_SIDED|95.0|-8.43|1.26||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysing was performed with ANCOVA model, adjusted for several terms.||Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.||1.26|-8.43|0.147
91750348|NCT01300819|183393207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.002|TWO_SIDED|95.0|-4.27|-0.92||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.92|-4.27|0.002
91750349|NCT01300819|183393208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.024|TWO_SIDED|95.0|-5.21|-0.37||Two-sided p-values are presented.|ANCOVA|Testing was performed using an ANCOVA model, adjusted for several terms.||||-0.37|-5.21|0.024
91750350|NCT01300819|183393209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.773|TWO_SIDED|95.0|-0.67|0.5||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.50|-0.67|0.773
91750351|NCT01300819|183393210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.122|TWO_SIDED|95.0|-2.41|0.29||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.29|-2.41|0.122
91750352|NCT01300819|183393211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.047|TWO_SIDED|95.0|-3.59|-0.02||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.02|-3.59|0.047
91750353|NCT01300819|183393212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.601|TWO_SIDED|95.0|-0.22|0.37||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.37|-0.22|0.601
91750354|NCT01300819|183393213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.997|TWO_SIDED|95.0|-0.99|0.99||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.99|-0.99|0.997
91750355|NCT01300819|183393214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.584|TWO_SIDED|95.0|-0.87|0.49||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.49|-0.87|0.584
91750356|NCT01300819|183393215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.536|TWO_SIDED|95.0|-0.84|1.6||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||1.60|-0.84|0.536
91750357|NCT01300819|183393216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.889|TWO_SIDED|95.0|-0.81|0.94||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.94|-0.81|0.889
91750358|NCT01300819|183393217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.043|TWO_SIDED|95.0|-2.06|-0.03||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.03|-2.06|0.043
91750359|NCT00438854|183393219|SUPERIORITY_OR_OTHER||Estimating proportion of responders|0.2||||||||||||||The primary measures of efficacy of tumor response were: complete remission (CR), nodular partial remission (nPR), or partial remission (PR), as per NCI-WG criteria. The true ORR is reported as percentage and 90% CI calculated using the binomial exact test. Time to treatment failure (TTF) was defined from the date on study to date of progression, death in remission, initiation of non-protocol therapy in the absence of progression, or censored on the last visit.||||
91750360|NCT05693922|183393240|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
91750361|NCT05693922|183393241|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
91532131|NCT05516342|182940590|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91532132|NCT05516342|182940591|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91750362|NCT05693922|183393242|SUPERIORITY|||||||0.865|||||||ANOVA|||||||0.865
91750363|NCT04239222|183393292|SUPERIORITY|A sample size of 22 subjects was required to provide 80% power to detect a difference of 5 points on the PLUS-M scale using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 7.7 was used to calculate the sample size.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|4.17||0.286|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot,|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean PLUS-M score using the Revo-M and μEveryday is the mean PLUS-M score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (11 negative, 8 positive and 4 null), Z=-1.066.|||0.286
91750364|NCT04239222|183393293|SUPERIORITY|A sample size of 21 subjects was required to provide 80% power to detect a difference of 0.2 points in the TAPES-AR score using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 0.3 was used to calculate the sample size.|Mean Difference (Final Values)|-0.094|STANDARD_DEVIATION|0.212||0.031|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≥ μEveryday, μRevo-M is the mean TAPES-AR score using the Revo-M and μEveryday is the mean TAPES-AR score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (5 negative, 13 positive and 5 null), Z=-2.156|||0.031
91750365|NCT04239222|183393295|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_DEVIATION|8.29||0.421|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean ABC score using the Revo-M and μEveryday is the mean ABC score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (12 negative, 7 positive and 4 null), Z=-0.805.|||0.421
91750366|NCT04239222|183393296|SUPERIORITY||Mean Difference (Final Values)|0.087|STANDARD_DEVIATION|0.844||0.443|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean TAPES-FUN score using the Revo-M and μEveryday is the mean TAPES-FUN score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (6 negative, 9 positive and 8 null), Z=-0.767.|||0.443
91750367|NCT00090233|183393306|NON_INFERIORITY_OR_EQUIVALENCE|Relative Risk ≤10.0 (non-inferiority margin).|relative risk|1.6||||0.006||95.0|0.4|6.4||"p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.~Adjusted for group-sequential design."|Exact binomial test|Exact binomial test adjusted for group-sequential design.||||6.4|0.4|0.006
91750368|NCT00090233|183393307|SUPERIORITY_OR_OTHER||Proportion|81.2|||<|0.001||95.0|72.9|87.8||p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.|Exact binomial test|||||87.8|72.9|<0.001
91750369|NCT00090233|183393308|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|74.0|||<|0.001||95.0|66.8|79.9||"Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.~Based on conditional binomial approach."|Exact binomial test|Exact binomial test.|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||79.9|66.8|<0.001
91750370|NCT00090233|183393309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|94.5|||<|0.001||95.0|91.2|96.6||Rate Reduction\>0%|Poisson regression|"Poisson regression with generalized estimating equations.~Validated with Van Elteren's extension of Wilcoxon Rank Sum test."|Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.|||96.6|91.2|<0.001
91750371|NCT00090233|183393310|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|81.5|||<|0.001||95.0|74.9|86.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Estimated value is based on the worst episode scores.|||86.7|74.9|<0.001
91750372|NCT00090233|183393311|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|98.0|||<|0.001||95.0|88.3|100.0||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact binomial test|||||100|88.3|<0.001
91750373|NCT00090233|183393312|NON_INFERIORITY_OR_EQUIVALENCE|Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).|||||<|0.001||95.0||||p\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.|Miettenen and Nurminen|||||||<0.001
91750374|NCT00090233|183393313|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis PT|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.||1.1|0.7|<0.001
91750375|NCT00090233|183393313|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis FHA|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.||1.1|0.7|<0.001
91750376|NCT00090233|183393313|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis Pertactin|0.6||||0.193|TWO_SIDED|95.0|0.4|0.8|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.||0.8|0.4|0.193
91750377|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 4|1.2|||<|0.001||95.0|1.0|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.||1.4|1.0|<0.001
91750378|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 6B|1.4|||<|0.001|TWO_SIDED|95.0|1.0|1.9|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.||1.9|1.0|<0.001
91532133|NCT05516342|182940592|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91750379|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 9V|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.||1.3|0.9|<0.001
91532134|NCT05516342|182940593|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
91532135|NCT05516342|182940594|SUPERIORITY|||||||0.89|||||||ANOVA|||||||0.89
91750380|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 14|1.0|||<|0.001|TWO_SIDED|95.0|0.7|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.||1.3|0.7|<0.001
91750381|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 18C|1.3|||<|0.001|TWO_SIDED|95.0|1.1|1.6|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.||1.6|1.1|<0.001
91750382|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 19F|1.1|||<|0.001|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.||1.4|0.8|<0.001
91532136|NCT05516342|182940595|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
91532137|NCT05516342|182940596|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
91750383|NCT00090233|183393314|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 23F|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.5|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.||1.5|0.9|<0.001
91750384|NCT01779869|183393316|SUPERIORITY|Accuracy was assessed compared to an imaging reference standard.||||||0.35|||||||Chi-squared|||Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value \< 0.05 was considered significant.||||0.35
91750385|NCT04754230|183393361|OTHER|||||||0.8|||||||two sided Z-test|This estimate uses two sided Z-test while assuming type I error=0.05||Comparison of bleeding at day 1||||0.8
91750386|NCT00957944|183393391|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0302||||||90.0|0.9693|1.0951|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0951|0.9693|
91750387|NCT00957944|183393392|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0571||||||90.0|0.9903|1.1284|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.1284|0.9903|
91750388|NCT00957944|183393393|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0289||||||90.0|0.9714|1.0899|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0899|0.9714|
91750389|NCT01030874|183393435|OTHER||Odds Ratio (OR)|1.16||||0.6|TWO_SIDED|95.0|0.67|1.99|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at baseline.|Arm 2 is in the numerator of OR calculation.|||1.99|0.67|0.6
91750390|NCT01030874|183393436|OTHER||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.74|3.24|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at discharge.|Arm 2 is in the numerator of OR calculation.|||3.24|0.74|0.3
91750391|NCT05257148|183393437|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91750392|NCT03883113|183393499|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
91750393|NCT03883113|183393499|OTHER|||||||0.1654|||||||Wilcoxon (Mann-Whitney)|||||||0.1654
91750394|NCT03883113|183393499|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
91750395|NCT03883113|183393500|OTHER|||||||1|||||||Fisher Exact|||The statistical analysis applies to participants with Virologically confirmed Influenza-like Illness versus participants without Virologically confirmed Influenza-like Illness||||1.000
91750396|NCT03883113|183393501|OTHER|||||||0.143|||||||Fisher Exact|||This statistical analysis applies to participants with qPCR confirmed Influenza versus participants with no qPCR confirmed Influenza||||0.143
91750397|NCT03883113|183393502|OTHER|||||||0.3504|||||||Fisher Exact|||This statistical analysis applies to participants with qCulture confirmed Influenza versus participants without qCulture confirmed Influenza||||0.3504
91532138|NCT05516342|182940597|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
91532139|NCT00839982|182940653|SUPERIORITY|||||||0.03||||||Hypothesis: achieving CR provides an overall longer survival.|Chi-squared|||||||0.03
91532140|NCT02724020|182940659|SUPERIORITY||Hazard Ratio (HR)|1.33|||=|0.388|TWO_SIDED|95.0|0.75|2.36|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.36|0.75|=0.388
91750398|NCT03883113|183393503|OTHER|||||||0.5558|||||||Log Rank|||||||0.5558
91750399|NCT03883113|183393504|OTHER|||||||0.6534|||||||Log Rank|||||||0.6534
91750400|NCT03883113|183393505|OTHER|||||||0.5485|||||||Wilcoxon (Mann-Whitney)|||||||0.5485
91750401|NCT03883113|183393506|OTHER|||||||0.6753|||||||Wilcoxon (Mann-Whitney)|||||||0.6753
91750402|NCT03883113|183393507|OTHER|||||||0.711|||||||Log Rank|||||||0.711
91750403|NCT03883113|183393508|OTHER|||||||0.4689|||||||Log Rank|||||||0.4689
91505508|NCT01713868|182881206|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.||||||0.03||||||Adjusted education effect p=0.34. Adjusted mHealth effect p\<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||0.03
91505509|NCT01713868|182881207|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect: p=0.22. Adjusted mHealth effect p\<0.001. Test for interaction p=0.08.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.||||<0.001
91505510|NCT01713868|182881208|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.07. Adjusted mHealth effect p\<0.001. Test for interaction p=0.54|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
91532141|NCT02724020|182940659|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.667|TWO_SIDED|95.0|0.75|2.52|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.52|0.75|0.667
91532142|NCT02724020|182940661|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.212|TWO_SIDED|95.0|0.89|3.49|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||3.49|0.89|0.212
91750404|NCT03883113|183393511|OTHER|||||||0.5001|||||||Wilcoxon (Mann-Whitney)|||||||0.5001
91750405|NCT03883113|183393512|OTHER|||||||0.6799|||||||zero-inflated poisson model|||||||0.6799
91750406|NCT03883113|183393513|OTHER|||||||0.5911|||||||Wilcoxon (Mann-Whitney)|||||||0.5911
91750407|NCT00395135|183393521|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|3.0|4.2|||ANCOVA|||||4.2|3.0|<0.0001
91750408|NCT00395135|183393523|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-3.67|||<|0.001|TWO_SIDED|95.0|-4.09|-3.25|||ANCOVA|||||-3.25|-4.09|<0.001
91750409|NCT00395135|183393524|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.29|-1.88|||ANCOVA|||||-1.88|-3.29|<0.001
91750410|NCT00395135|183393524|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|1.64|||<|0.001|TWO_SIDED|95.0|1.1|2.19|||ANCOVA|||||2.19|1.10|<0.001
91505511|NCT01713868|182881209|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.33. Adjusted mHealth effect p\<0.001. Test for interaction p=0.29.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
91505512|NCT01713868|182881210|OTHER|Causal mediation analysis|Difference in proportions|0.16|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
91505513|NCT01713868|182881211|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
91505514|NCT01713868|182881212|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
91505515|NCT01713868|182881213|OTHER|Causal mediation analysis|Difference in proportions|0.15|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
91505516|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505517|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505518|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505519|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505520|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505521|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505522|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505523|NCT03026257|182881281|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
91505524|NCT03265249|182881339|SUPERIORITY||Median Difference (Final Values)|5.7||||0.8|TWO_SIDED|95.0|-17.5|29.0|||Mixed Models Analysis|||||29|-17.5|0.80
91505525|NCT00644969|182881371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.74||||0.0457|TWO_SIDED|95.0|1.03|21.78|||Regression, Logistic|||||21.78|1.03|0.0457
91505526|NCT00644969|182881372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18||||0.0901|TWO_SIDED|95.0|0.75|50.71|||Regression, Logistic|||||50.71|0.75|0.0901
91505527|NCT00644969|182881373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.1524|TWO_SIDED|95.0|0.82|3.68|||Regression, Logistic|||Week 12||3.68|0.82|0.1524
91505528|NCT00644969|182881373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9235|TWO_SIDED|95.0|0.45|2.05|||Regression, Logistic|||Week 24||2.05|0.45|0.9235
91505529|NCT00644969|182881374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.0077|TWO_SIDED|95.0|-6.32|-0.99|||ANCOVA||Least squares mean difference|Week 12 treatment difference||-0.99|-6.32|0.0077
91505530|NCT00644969|182881374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.9022|TWO_SIDED|95.0|-3.99|3.52|||ANCOVA||Least squares mean difference|Week 24 treatment difference||3.52|-3.99|0.9022
91505531|NCT01933048|182881375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.43|||||||Farrington-Manning Method|based on margin of 0.05||A/H1N1||||0.43
91505532|NCT01933048|182881375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.8|||||||Farrington-Manning Method|based on margin of 0.05||A/H3N2||||0.80
91505533|NCT01933048|182881375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.55|||||||Farrington-Manning Method|based on margin of 0.05||B/Yamagata||||0.55
91505534|NCT01933048|182881375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.16|||||||Farrington-Manning Method|based on margin of 0.05||B/Brisbane||||0.16
91505535|NCT01714310|182881416|SUPERIORITY|||||||0.58||||||Group: F=.31, df=1/140|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.58
91505536|NCT01714310|182881416|SUPERIORITY|||||||0.85||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.03, df=1/140||||||.85
91505537|NCT01714310|182881416|SUPERIORITY|||||||0.26||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=1.28, df=1/140||||||.26
91505538|NCT01714310|182881417|SUPERIORITY|||||||0.97||||||Group: F=0.00, df=1/44|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.97
91505539|NCT01714310|182881417|SUPERIORITY||||||<|0.0002||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=136.22, df=1/44||||||<.0002
91505540|NCT01714310|182881417|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=64.90, df=1/44||||||<.0001
91505541|NCT01714310|182881418|SUPERIORITY||||||<|0.0001||||||Time: F=41.85, df=1/89, p\<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
91505542|NCT01714310|182881419|SUPERIORITY||||||<|0.0001||||||Time: F=26.65, df=1/92, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
91505543|NCT01714310|182881420|SUPERIORITY||||||<|0.0001||||||Time: F=40.35, df=1/89, p \< .0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
91505544|NCT01714310|182881421|SUPERIORITY||||||<|0.0001||||||Time: F=26.36, df=1/29, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
91505545|NCT01714310|182881422|SUPERIORITY|||||||0.44||||||Group: F=.60, df=1/157|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.44
91505546|NCT01714310|182881422|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=22.39, df=1/157||||||<.0001
91505547|NCT01714310|182881422|SUPERIORITY|||||||0.04||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=4.40, df=1/157||||||.04
91532143|NCT02724020|182940661|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.546|TWO_SIDED|95.0|0.77|2.98|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.98|0.77|0.546
91505548|NCT01714310|182881423|SUPERIORITY|||||||0.05||||||Group: F=3.81, df=1/145|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||No significant group\*time interactions. Group trend likely due to baseline differences.|||.05
91505549|NCT01714310|182881423|SUPERIORITY|||||||0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Tie: F=15.28, df=1/145||||||.0001
91505550|NCT01714310|182881423|SUPERIORITY|||||||0.02||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=5.42, df=1/145||||||.02
91505551|NCT01714310|182881424|SUPERIORITY|||||||0.76|||||||Chi-squared|Chi Square = .10, df=1, p=.76||||||.76
91505552|NCT01714310|182881425|SUPERIORITY|||||||0.38||||||Group: F=.78, df=1/220|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.38
91505553|NCT01714310|182881425|SUPERIORITY|||||||0.42||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.66, df=1/220||||||.42
91505554|NCT01714310|182881425|SUPERIORITY|||||||0.13||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.66, df=1/220||||||.13
91505555|NCT01714310|182881426|SUPERIORITY|||||||0.21||||||Group: F=1.56, df=1/222|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.21
91505556|NCT01714310|182881426|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=63.11, df=1/222||||||<.0001
91505557|NCT01714310|182881426|SUPERIORITY|||||||0.0004||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=12.86, df=1/222||||||.0004
91505558|NCT01714310|182881427|SUPERIORITY|||||||0.02||||||Group: F=5.42, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.02
91505559|NCT01714310|182881427|SUPERIORITY|||||||0.18||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.77, df=1/223||||||.18
91505560|NCT01714310|182881427|SUPERIORITY|||||||0.49||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.47, df=1/223||||||.49
91505561|NCT01714310|182881428|SUPERIORITY|||||||0.9||||||Group: F=.02, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.90
91505562|NCT01714310|182881428|SUPERIORITY|||||||0.21||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.60, df=1/223||||||.21
91505563|NCT01714310|182881428|SUPERIORITY|||||||0.73||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.12, df=1/223||||||.73
91505564|NCT01714310|182881429|SUPERIORITY|||||||0.15||||||Group: F=2.05, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.15
91505565|NCT01714310|182881429|SUPERIORITY|||||||0.59||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.29, df=1/223||||||.59
91505566|NCT01714310|182881429|SUPERIORITY|||||||0.14||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=2.15, df=1/223||||||.14
91505567|NCT01420289|182881442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|15.0||0.086|TWO_SIDED|95.0|10.0|80.0|||t-test, 2 sided|||||80|10|0.086
91505568|NCT01420289|182881443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.05|TWO_SIDED|95.0|10.0|100.0|||t-test, 2 sided|||||100|10|<0.05
91505569|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.74||||0|TWO_SIDED|95.0|0.68|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Non-smoker)||0.82|0.68|0.000
91750411|NCT02323204|183393525|OTHER|||||||0.6298|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6298
91505570|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.32||||0|TWO_SIDED|95.0|1.14|1.52|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Ex-smoker)||1.52|1.14|0.000
91750412|NCT02323204|183393525|OTHER|||||||0.2341|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2341
91505571|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.04||||0|TWO_SIDED|95.0|0.93|1.17|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Smoker)||1.17|0.93|0.000
91505572|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.95||||0.755|TWO_SIDED|95.0|0.8|1.13|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.80|0.755
91505573|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.32||||0.426|TWO_SIDED|95.0|0.95|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)||1.83|0.95|0.426
91532144|NCT02724020|182940662|SUPERIORITY||Hazard Ratio (HR)|1.57|||=|0.156|TWO_SIDED|95.0|0.81|3.05|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||3.05|0.81|=0.156
91532145|NCT02724020|182940662|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.667|TWO_SIDED|95.0|0.72|2.79|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||2.79|0.72|0.667
91532146|NCT02724020|182940663|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.08|2.22|||||Odds ratio and 95% CI were obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|As prespecified in the protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only.|As prespecified in protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only for this outcome measure.|2.22|0.08|
91750413|NCT02323204|183393526|OTHER|||||||0.7893|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7893
91505574|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.77|1.12|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Smoker)||1.12|0.77|0.930
91505575|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.78||||0|TWO_SIDED|95.0|0.72|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Non-smoker)||0.84|0.72|0.000
91505576|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.42|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)||1.42|1.10|0.000
91505577|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.98|1.19|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Smoker)||1.19|0.98|0.000
91505578|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.98||||0.755|TWO_SIDED|95.0|0.84|1.14|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)||1.14|0.84|0.755
91505579|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.13||||0.426|TWO_SIDED|95.0|0.84|1.52|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)||1.52|0.84|0.426
91505580|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.98||||0.93|TWO_SIDED|95.0|0.81|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Smoker)||1.12|0.81|0.930
91505581|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.79||||0|TWO_SIDED|95.0|0.74|0.84|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Non-smoker)||0.84|0.74|0.000
91505582|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.19||||0|TWO_SIDED|95.0|1.08|1.32|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)||1.32|1.08|0.000
91505583|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|1.08|1.26|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Smoker)||1.26|1.08|0.000
91505584|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.82||||0.755|TWO_SIDED|95.0|0.6|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.60|0.755
91505585|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.48||||0.426|TWO_SIDED|95.0|0.82|2.52|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)||2.52|0.82|0.426
91505586|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.0||||0.93|TWO_SIDED|95.0|0.7|1.4|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Smoker)||1.40|0.70|0.930
91505587|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.54||||0|TWO_SIDED|95.0|0.49|0.6|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Non-smoker)||0.60|0.49|0.000
91505588|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.51||||0|TWO_SIDED|95.0|1.29|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Ex-smoker)||1.76|1.29|0.000
91532147|NCT02724020|182940664|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.24|1.69|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.69|0.24|
91505589|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.72||||0|TWO_SIDED|95.0|1.54|1.93|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.93|1.54|0.000
91505590|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.91||||0.755|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Non-smoker)||1.17|0.72|0.755
91750414|NCT02323204|183393526|OTHER|||||||0.2951|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2951
91505591|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|1.25||||0.426|TWO_SIDED|95.0|0.78|1.95|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Ex-smoker)||1.95|0.78|0.426
91505592|NCT03441633|182881449|SUPERIORITY||Odds Ratio (OR)|0.92||||0.93|TWO_SIDED|95.0|0.7|1.2|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.20|0.70|0.930
91532148|NCT02724020|182940664|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.21|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||2.21|0.28|
91505593|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.99||||0|TWO_SIDED|95.0|0.9|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (No intake)||1.09|0.90|0.000
91505594|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.98|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Moderate intake)||1.25|0.98|0.000
91505595|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.52||||0.164|TWO_SIDED|95.0|0.94|2.45|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Risk consumption)||2.45|0.94|0.164
91532149|NCT02724020|182940665|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.16|1.38|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.38|0.16|
91532150|NCT02724020|182940665|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.2|1.8|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.80|0.20|
91505596|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.03||||0.826|TWO_SIDED|95.0|0.87|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (No intake)||1.22|0.87|0.826
91505597|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.16||||0.19|TWO_SIDED|95.0|0.94|1.43|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Moderate intake)||1.43|0.94|0.190
91505598|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.58||||0.526|TWO_SIDED|95.0|0.18|1.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Risk consumption)||1.57|0.18|0.526
91505599|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (No intake)||0.91|0.77|0.000
91505600|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|1.01|1.24|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Moderate intake)||1.24|1.01|0.000
91505601|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.17||||0.164|TWO_SIDED|95.0|0.76|1.83|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Risk consumption)||1.83|0.76|0.164
91505602|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.09||||0.826|TWO_SIDED|95.0|0.95|1.26|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (No intake)||1.26|0.95|0.826
91505603|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.93||||0.19|TWO_SIDED|95.0|0.77|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)||1.13|0.77|0.190
91505604|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.26||||0.526|TWO_SIDED|95.0|0.62|2.65|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)||2.65|0.62|0.526
91505605|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.28|1.45|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (No intake)||1.45|1.28|0.000
91505606|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.24||||0|TWO_SIDED|95.0|1.14|1.35|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Moderate intake)||1.35|1.14|0.000
91505607|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.98|1.95|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Risk consumption)||1.95|0.98|0.164
91505608|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.04||||0.826|TWO_SIDED|95.0|0.76|1.41|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (No intake)||1.41|0.76|0.826
91505609|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.22||||0.19|TWO_SIDED|95.0|0.82|1.76|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)||1.76|0.82|0.190
91505610|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.21||||0.526|TWO_SIDED|95.0|0.17|4.5|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)||4.50|0.17|0.526
91505611|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.16|1.42|||Chi-squared|||Warfarin vs. Apixaban in naive participants (No intake)||1.42|1.16|0.000
91505612|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Moderate intake)||1.43|1.10|0.000
91505613|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.92||||0.164|TWO_SIDED|95.0|0.49|1.64|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Risk consumption)||1.64|0.49|0.164
91750415|NCT02323204|183393527|OTHER|||||||0.7166|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7166
91505614|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|1.06||||0.826|TWO_SIDED|95.0|0.84|1.34|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (No intake)||1.34|0.84|0.826
91505615|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.91||||0.19|TWO_SIDED|95.0|0.66|1.23|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Moderate intake)||1.23|0.66|0.190
91505616|NCT03441633|182881450|SUPERIORITY||Odds Ratio (OR)|0.64||||0.526|TWO_SIDED|95.0|0.09|2.36|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Risk consumption)||2.36|0.09|0.526
91505617|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.2|1.53|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.53|1.20|0.000
91532151|NCT02954575|182940690|OTHER||Poisson test estimate|2.13|||<|0.0001|TWO_SIDED|95.0|1.64|2.76||versus mean TABR \>29|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualized bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the TABR reported in the GENA-01 study (NCT00989196), which observed 58.1 BEs per patient per year. A corresponding two-sided 95% CI for the TABR was also analyzed.||2.76|1.64|<0.0001
91750416|NCT02323204|183393527|OTHER|||||||0.4501|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4501
91505618|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.01||||0.014|TWO_SIDED|95.0|0.89|1.15|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.15|0.89|0.014
91505619|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.87||||0|TWO_SIDED|95.0|0.77|0.99|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.99|0.77|0.000
91505620|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.86||||0|TWO_SIDED|95.0|0.75|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.97|0.75|0.000
91750417|NCT02323204|183393528|OTHER|||||||0.6756|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6756
91505621|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.85||||0.013|TWO_SIDED|95.0|0.74|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.97|0.74|0.013
91505622|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.05||||0.157|TWO_SIDED|95.0|0.84|1.31|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.31|0.84|0.157
91505623|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.03||||0.124|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.82|0.124
91505624|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.77||||0.062|TWO_SIDED|95.0|0.61|0.96|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.61|0.062
91505625|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.98||||0.079|TWO_SIDED|95.0|0.78|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.22|0.78|0.079
91505626|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.09||||0.14|TWO_SIDED|95.0|0.86|1.38|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.38|0.86|0.140
91505627|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|1.17|1.45|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.45|1.17|0.000
91505628|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.97||||0.014|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.09|0.87|0.014
91505629|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.91|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.12|0.91|0.000
91505630|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.94||||0|TWO_SIDED|95.0|0.85|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)||1.05|0.85|0.000
91505631|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.83||||0.013|TWO_SIDED|95.0|0.74|0.93|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.93|0.74|0.013
91505632|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.92||||0.157|TWO_SIDED|95.0|0.76|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.13|0.76|0.157
91505633|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.98||||0.124|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.20|0.81|0.124
91505634|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.79||||0.062|TWO_SIDED|95.0|0.65|0.96|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.65|0.062
91505635|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.23||||0.079|TWO_SIDED|95.0|1.02|1.48|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.48|1.02|0.079
91505636|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.21||||0.14|TWO_SIDED|95.0|0.99|1.49|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.49|0.99|0.140
91505637|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.96||||0|TWO_SIDED|95.0|0.88|1.05|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.05|0.88|0.000
91505638|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.91||||0.014|TWO_SIDED|95.0|0.84|0.99|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.99|0.84|0.014
91505639|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.83||||0|TWO_SIDED|95.0|0.76|0.9|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.90|0.76|0.000
91532152|NCT02954575|182940691|OTHER||Poisson test estimate|1.53|||<|0.0001|TWO_SIDED|95.0|1.13|2.08||versus mean SABR \>19.1|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean SABR in patients treated prophylactically with Wilate was below the threshold of 19.1 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the SABR in the GENA-01 study (NCT00989196), which observed 38.2 spontaneous BEs per patient per year. A corresponding two-sided 95% CI for the SABR was also analyzed.||2.08|1.13|<0.0001
91505640|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.91|0.77|0.000
91505641|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.92||||0.013|TWO_SIDED|95.0|0.85|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.00|0.85|0.013
91505642|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.03||||0.157|TWO_SIDED|95.0|0.68|1.54|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.54|0.68|0.157
91532153|NCT02954575|182940692|OTHER||Generalized estimation equation|84.21||||0.0096|TWO_SIDED|95.0|72.13|92.52|||Confirmatory data analysis|||"Confirmatory statistical testing tested the null hypotheses that the percentage of success is ≤70% (alternative hypothesis: percentage \>70%); the test procedure based on the generalized estimation equation took into account several BEs in one patient as correlated repeated measurements (alpha = 2.5%). Thus, π denotes the proportion of success and the following pair of hypotheses was tested:~H0: π ≤ 0.7 vs. H1: π \> 0.7"||92.52|72.13|0.0096
91505643|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.84||||0.124|TWO_SIDED|95.0|0.53|1.29|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.53|0.124
91505644|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.75||||0.062|TWO_SIDED|95.0|0.48|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.13|0.48|0.062
91505645|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.88||||0.079|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.33|0.57|0.079
91505646|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.05||||0.14|TWO_SIDED|95.0|0.67|1.59|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.59|0.67|0.140
91505647|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.39||||0|TWO_SIDED|95.0|0.32|0.47|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)||0.47|0.32|0.000
91505648|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.84||||0.014|TWO_SIDED|95.0|0.73|0.97|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.97|0.73|0.014
91505649|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.7||||0|TWO_SIDED|95.0|1.51|1.91|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.91|1.51|0.000
91505650|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.86||||0|TWO_SIDED|95.0|1.65|2.1|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)||2.10|1.65|0.000
91505651|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.94||||0.013|TWO_SIDED|95.0|0.82|1.08|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.08|0.82|0.013
91505652|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.35||||0.157|TWO_SIDED|95.0|1.0|1.8|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.80|1.00|0.157
91505653|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|1.41||||0.124|TWO_SIDED|95.0|1.04|1.88|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.88|1.04|0.124
91505654|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.76||||0.062|TWO_SIDED|95.0|0.55|1.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.05|0.55|0.062
91505655|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.92||||0.079|TWO_SIDED|95.0|0.67|1.26|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.26|0.67|0.079
91505656|NCT03441633|182881451|SUPERIORITY||Odds Ratio (OR)|0.81||||0.14|TWO_SIDED|95.0|0.56|1.15|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.15|0.56|0.140
91505657|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.25|0.91|0.000
91505658|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.38||||0.202|TWO_SIDED|95.0|0.58|3.23|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.23|0.58|0.202
91505659|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.98||||0|TWO_SIDED|95.0|0.88|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.09|0.88|0.000
91505660|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.84||||0.003|TWO_SIDED|95.0|0.76|0.93|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.93|0.76|0.003
91505661|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.82||||0.083|TWO_SIDED|95.0|0.66|1.03|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.03|0.66|0.083
91505662|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.99||||0.011|TWO_SIDED|95.0|0.68|6.18|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.18|0.68|0.011
91532154|NCT02954575|182940698|OTHER|||||||0.0346|||||||ANOVA|||||||0.0346
91532155|NCT02954575|182940699|OTHER|||||||0.4244|||||||ANOVA|||||||0.4244
91532156|NCT02954575|182940701|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|16.11||||||||16.11|0|
91532157|NCT01438229|182940784|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91532158|NCT04770220|182940867|OTHER|"For the primary efficacy outcome of ADAS-Cog 13, this study has \>90% power to detect a 3.0-point difference between the active ALZ-801 treatment and the placebo in the CBL to Week 78. An increase in ADAS-Cog scores denotes cognitive worsening.~The primary analysis population was the full analysis set (FAS). The FAS included all study subjects who received at least one dose of the study drug and had at least one baseline assessment and any post baseline efficacy assessment."|Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.98||0.6058|TWO_SIDED|||||Statistical testing was two-sided at the α=0.05 significance level. Between-treatment group comparison (effect in ALZ-801 minus effect in placebo): LSM difference and p-value.|MMRM||ALZ-801 minus placebo|"The null hypothesis was change from baseline (CBL) of ADAS-Cog13 in the ALZ-801 arm was not different from the placebo arm. The alternative hypothesis was that the CBL of ADAS-Cog13 in ALZ-801 arm was different.~A Mixed-Effect Model Repeated Measure (MMRM) model was used with fixed terms for treatment, gender, age group, disease severity based on baseline MMSE (≤ 26 vs. \> 26), concomitant AD medications, visit, and treatment by visit interaction and baseline ADAS-Cog 13 values as covariates."||||0.6058
91532159|NCT04770220|182940869|OTHER||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|2.84||0.9966|TWO_SIDED|||||Nominal p-value|MMRM|Nominal (descriptive only)|ALZ-801 minus placebo|"The A-IADL-W is one of 2 key secondary endpoints. The key secondary efficacy endpoints were to be compared only after the comparison of the primary endpoint has reached statistical significance. Because the primary endpoint did not reach statistical significance, the comparisons for the key secondary endpoints are descriptive only.~The same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the key secondary endpoints."||||0.9966
91505663|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.89||||0.227|TWO_SIDED|95.0|0.75|1.06|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.06|0.75|0.227
91505664|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.47|1.03|0.000
91532160|NCT04770220|182940870|OTHER||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.31||0.309|TWO_SIDED|||||Nominal p-value|MMRM||ALZ-801 minus placebo|"The CDR-SB is one of 2 key secondary endpoints. The key secondary efficacy endpoints were to be compared only after the comparison of the primary endpoint has reached statistical significance. Because the primary endpoint did not reach statistical significance, the comparisons for the key secondary endpoints are descriptive only.~The same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the key secondary endpoints."||||0.3090
91532161|NCT04770220|182940871|OTHER||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.4||0.2763|TWO_SIDED|||||Nominal p-value|MMRM|Nominal (descriptive only)|ALZ-801 minus placebo|The same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the additional secondary endpoints. The hypothesis testing was done without control for type I errors due to multiple comparisons, and the p-value was considered nominal.||||0.2763
91532162|NCT04770220|182940872|OTHER||Least Squares Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.47||0.4484|TWO_SIDED|||||Nominal p-value|MMRM|Nominal (descriptive only)|ALZ-801 minus placebo|The same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the additional secondary endpoints. The hypothesis testing was done without control for type I errors due to multiple comparisons, and the p-value was considered nominal.||||0.4484
91532163|NCT04770220|182940873|OTHER||Least Squares Mean Difference|73.505|STANDARD_ERROR_OF_MEAN|30.711||0.0174|TWO_SIDED|||||Nominal p-value|MMRM||ALZ-801 minus placebo.|Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.||||0.0174
91505665|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.88|1.16|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.16|0.88|0.000
91532164|NCT04770220|182940874|OTHER||Least Squares Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.004||0.002|TWO_SIDED|||||Nominal p-value|MMRM||ALZ-801 minus placebo|Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.||||0.0020
91505666|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.22||||0.202|TWO_SIDED|95.0|0.58|2.66|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.66|0.58|0.202
91505667|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.95||||0|TWO_SIDED|95.0|0.87|1.04|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.04|0.87|0.000
91750418|NCT02323204|183393528|OTHER|||||||0.5381|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5381
91750419|NCT02323204|183393529|OTHER|||||||0.1507|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.1507
91750420|NCT02323204|183393529|OTHER|||||||0.0769|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0769
91750421|NCT02323204|183393530|OTHER|||||||0.0654|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0654
91750422|NCT02323204|183393530|OTHER|||||||0.7957|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7957
91750423|NCT02323204|183393531|OTHER|||||||0.0286|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0286
91750424|NCT02323204|183393531|OTHER|||||||0.0201|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0201
91750425|NCT02323204|183393532|OTHER|||||||0.9928|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.9928
91505668|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.87||||0.003|TWO_SIDED|95.0|0.8|0.95|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.95|0.80|0.003
91505669|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.97||||0.083|TWO_SIDED|95.0|0.8|1.17|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.17|0.80|0.083
91750426|NCT02323204|183393532|OTHER|||||||0.0982|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0982
91750427|NCT02323204|183393533|OTHER|||||||0.0325|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0325
91505670|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.06||||0.011|TWO_SIDED|95.0|0.02|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||1.05|0.02|0.011
91505671|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.84||||0.227|TWO_SIDED|95.0|0.72|0.98|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||0.98|0.72|0.227
91505672|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|0.99|1.35|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.35|0.99|0.000
91505673|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.63||||0|TWO_SIDED|95.0|1.47|1.82|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.82|1.47|0.000
91505674|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.7||||0.202|TWO_SIDED|95.0|0.98|3.25|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.25|0.98|0.202
91505675|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.29||||0|TWO_SIDED|95.0|1.2|1.38|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.38|1.20|0.000
91505676|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.94||||0.003|TWO_SIDED|95.0|0.88|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.00|0.88|0.003
91505677|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.86||||0.083|TWO_SIDED|95.0|0.56|1.28|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.28|0.56|0.083
91505678|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.49||||0.011|TWO_SIDED|95.0|0.13|8.58|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||8.58|0.13|0.011
91505679|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.04||||0.227|TWO_SIDED|95.0|0.75|1.42|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.42|0.75|0.227
91505680|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|0.81|1.55|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.55|0.81|0.000
91505681|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.5||||0|TWO_SIDED|95.0|1.28|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.76|1.28|0.000
91505682|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.04||||0.202|TWO_SIDED|95.0|0.36|2.73|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.73|0.36|0.202
91750428|NCT02323204|183393533|OTHER|||||||0.2568|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2568
91750429|NCT02323204|183393534|OTHER|||||||0.5824|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5824
91505683|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.15|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.43|1.15|0.000
91505684|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.95||||0.003|TWO_SIDED|95.0|0.86|1.06|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.06|0.86|0.003
91505685|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.27||||0.083|TWO_SIDED|95.0|0.95|1.68|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.68|0.95|0.083
91505686|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|0.18|6.21|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.21|0.18|0.011
91505687|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.92||||0.227|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.17|0.72|0.227
91505688|NCT03441633|182881452|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.5|0.87|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||0.87|0.50|0.000
91505689|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|0.68||||0|TWO_SIDED|95.0|0.61|0.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants||0.75|0.61|0.000
91505690|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|0.85||||0.052|TWO_SIDED|95.0|0.63|1.15|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||1.15|0.63|0.052
91505691|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|0.73||||0|TWO_SIDED|95.0|0.67|0.8|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants||0.80|0.67|0.000
91505692|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|0.79||||0.052|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.03|0.61|0.052
91505693|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|1.26||||0|TWO_SIDED|95.0|1.17|1.36|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants||1.36|1.17|0.000
91505694|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|0.74||||0.052|TWO_SIDED|95.0|0.45|1.27|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.27|0.45|0.052
91505695|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||Warfarin vs. Apixaban in naive participants||1.21|0.95|0.000
91505696|NCT03441633|182881453|SUPERIORITY||Odds Ratio (OR)|0.57||||0.052|TWO_SIDED|95.0|0.4|0.84|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.84|0.40|0.052
91505697|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0|TWO_SIDED|95.0|-0.26|-0.17|||ANOVA|||Dabigatran vs. Apixaban in naive participants (HAS - BLED)||-0.17|-0.26|0.000
91505698|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.001|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)||-0.01|-0.18|0.001
91505699|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0|TWO_SIDED|95.0|-0.23|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)||-0.15|-0.23|0.000
91505700|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.001|TWO_SIDED|95.0|-0.19|-0.04|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)||-0.04|-0.19|0.001
91505701|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|0.5||||0|TWO_SIDED|95.0|0.47|0.53|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (HAS - BLED)||0.53|0.47|0.000
91505702|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.001|TWO_SIDED|95.0|-0.32|-0.02|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)||-0.02|-0.32|0.001
91505703|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|0.17||||0|TWO_SIDED|95.0|0.12|0.23|||ANOVA|||Warfarin vs. Apixaban in naive participants (HAS - BLED)||0.23|0.12|0.000
91505704|NCT03441633|182881454|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (HAS - BLED)||-0.10|-0.37|0.001
91750430|NCT02323204|183393534|OTHER|||||||0.4635|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4635
91750431|NCT02323204|183393535|OTHER|||||||0.7949|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation over time between interventions was made through the intervention-time interaction effect included in the model. Significance in the interaction effect is indicative of a difference in the rate of change in implementation between interventions over time.||||0.7949
91505705|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0|TWO_SIDED|95.0|-0.24|-0.12|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHADS2)||-0.12|-0.24|0.000
91505706|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.35|-0.12|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHADS2)||-0.12|-0.35|0.000
91505707|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.28|-0.18|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHADS2)||-0.18|-0.28|0.000
91505708|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0|TWO_SIDED|95.0|-0.31|-0.11|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)||-0.11|-0.31|0.000
91505709|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|0.21||||0|TWO_SIDED|95.0|0.17|0.25|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHADS2)||0.25|0.17|0.000
91505710|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.7|-0.3|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHADS2)||-0.30|-0.70|0.000
91505711|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|0.08||||0|TWO_SIDED|95.0|0.01|0.14|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHADS2)||0.14|0.01|0.000
91505712|NCT03441633|182881455|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|95.0|-0.54|-0.2|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHADS2)||-0.20|-0.54|0.000
91505713|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0|TWO_SIDED|95.0|-0.42|-0.26|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.26|-0.42|0.000
91505714|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0|TWO_SIDED|95.0|-0.46|-0.19|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.19|-0.46|0.000
91505715|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0|TWO_SIDED|95.0|-0.45|-0.32|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.32|-0.45|0.000
91505716|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0|TWO_SIDED|95.0|-0.39|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.15|-0.39|0.000
91505717|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|0.19||||0|TWO_SIDED|95.0|0.14|0.24|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)||0.24|0.14|0.000
91505718|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0|TWO_SIDED|95.0|-0.86|-0.37|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.37|-0.86|0.000
91505719|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.01|-0.18|0.000
91505720|NCT03441633|182881456|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0|TWO_SIDED|95.0|-0.64|-0.21|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.21|-0.64|0.000
91505721|NCT03441633|182881457|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|0.77|5.3|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||5.30|0.77|0.008
91505722|NCT03441633|182881457|SUPERIORITY||Odds Ratio (OR)|0.62||||0.008|TWO_SIDED|95.0|0.33|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.12|0.33|0.008
91505723|NCT03441633|182881457|SUPERIORITY||Odds Ratio (OR)|0.55||||0.008|TWO_SIDED|95.0|0.2|1.99|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.99|0.20|0.008
91505724|NCT03441633|182881457|SUPERIORITY||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.18|0.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.86|0.18|0.008
91505725|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.14|1.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Poor adherence)||1.75|1.14|0.000
91505726|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.55|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Good adherence)||0.82|0.55|0.000
91505727|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.03|2.01|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Over adherence)||2.01|0.03|0.000
91505728|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.58||||0|TWO_SIDED|95.0|1.23|2.04|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Poor adherence)||2.04|1.23|0.000
91505729|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.44||||0|TWO_SIDED|95.0|0.34|0.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Good adherence)||0.57|0.34|0.000
91505730|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.43||||0|TWO_SIDED|95.0|0.02|3.73|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Over adherence)||3.73|0.02|0.000
91505731|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.66||||0|TWO_SIDED|95.0|0.52|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Poor adherence)||0.84|0.52|0.000
91505732|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.14||||0|TWO_SIDED|95.0|0.95|1.36|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Good adherence)||1.36|0.95|0.000
91505733|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.52||||0|TWO_SIDED|95.0|0.06|3.41|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Over adherence)||3.41|0.06|0.000
91505734|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.65||||0|TWO_SIDED|95.0|0.5|0.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)||0.85|0.50|0.000
91505735|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.9|1.37|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)||1.37|0.90|0.000
91505736|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.22|5.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)||5.85|0.22|0.000
91532165|NCT04770220|182940875|OTHER||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.007||0.004|TWO_SIDED|95.0||||Nominal p-value|MMRM||ALZ-801 minus placebo|Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.||||0.0040
91750432|NCT02323204|183393535|OTHER|||||||0.0003|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation between interventions was made through the intervention main effect included in the model. The model at hand does not contain an interaction between intervention and time. Significance in the main intervention effect is indicative of a difference in implementation between intervention groups.||||0.0003
91750433|NCT02014480|183393536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.065|0.151||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.151|0.065|<0.001
91505737|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|3.37||||0|TWO_SIDED|95.0|2.86|3.99|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Poor adherence)||3.99|2.86|0.000
91505738|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.11||||0|TWO_SIDED|95.0|0.09|0.13|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Good adherence)||0.13|0.09|0.000
91505739|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.34||||0|TWO_SIDED|95.0|0.11|1.52|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Over adherence)||1.52|0.11|0.000
91505740|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|0.78|1.91|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)||1.91|0.78|0.000
91750434|NCT02014480|183393536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.064|0.149||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.149|0.064|<0.001
91505741|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.01||||0|TWO_SIDED|95.0|0.0|0.09|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Good adherence)||0.09|0.00|0.000
91505742|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|2.07||||0|TWO_SIDED|95.0|0.07|18.0|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Over adherence)||18.00|0.07|0.000
91505743|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.58||||0|TWO_SIDED|95.0|0.45|0.75|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Poor adherence)||0.75|0.45|0.000
91505744|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.51||||0|TWO_SIDED|95.0|0.41|0.63|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Good adherence)||0.63|0.41|0.000
91505745|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|29.4||||0|TWO_SIDED|95.0|11.01|123.8|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Over adherence)||123.80|11.01|0.000
91505746|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|0.91|1.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Poor adherence)||1.86|0.91|0.000
91505747|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.05|0.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Good adherence)||0.17|0.05|0.000
91505748|NCT03441633|182881458|SUPERIORITY||Odds Ratio (OR)|9.73||||0|TWO_SIDED|95.0|2.81|46.5|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Over adherence)||46.50|2.81|0.000
91505749|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.92|1.27|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.92|0.000
91505750|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|1.45||||0|TWO_SIDED|95.0|1.15|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)||1.83|1.15|0.000
91505751|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|1.09||||0|TWO_SIDED|95.0|0.93|1.27|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.93|0.000
91505752|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|1.18||||0|TWO_SIDED|95.0|0.96|1.47|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)||1.47|0.96|0.000
91505753|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|0.89||||0|TWO_SIDED|95.0|0.79|1.01|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)||1.01|0.79|0.000
91505754|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|4.82||||0|TWO_SIDED|95.0|3.14|7.55|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)||7.55|3.14|0.000
91505755|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.19|1.67|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Discontinuation first year)||1.67|1.19|0.000
91505756|NCT03441633|182881459|SUPERIORITY||Odds Ratio (OR)|2.92||||0|TWO_SIDED|95.0|2.12|4.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)||4.05|2.12|0.000
91505757|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|3.63||||0|TWO_SIDED|95.0|3.02|4.24|||ANOVA|||Dabigatran vs. Apixaban in naive participants (NDDDs)||4.24|3.02|0.000
91505758|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|0.11||||0|TWO_SIDED|95.0|-0.77|0.98|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (NDDDs)||0.98|-0.77|0.000
91505759|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|1.51||||0|TWO_SIDED|95.0|0.84|2.17|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (NDDDs)||2.17|0.84|0.000
91505760|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|1.98||||0|TWO_SIDED|95.0|1.16|2.8|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)||2.80|1.16|0.000
91505761|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|0.9||||0|TWO_SIDED|95.0|0.41|1.39|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (NDDDs)||1.39|0.41|0.000
91505762|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0|TWO_SIDED|95.0|-4.32|-0.18|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (NDDDs)||-0.18|-4.32|0.000
91505763|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|28.52||||0|TWO_SIDED|95.0|27.56|29.48|||ANOVA|||Warfarin vs. Apixaban in naive participants (NDDDs)||29.48|27.56|0.000
91505764|NCT03441633|182881460|SUPERIORITY||Mean Difference (Final Values)|1.93||||0|TWO_SIDED|95.0|-1.05|4.9|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (NDDDs)||4.90|-1.05|0.000
91505765|NCT03161483|182881463|SUPERIORITY||Stratified difference|11.4||||0.214|TWO_SIDED|95.0|-6.57|29.0|||Cochran-Mantel-Haenszel|||||29.00|-6.57|0.214
91505766|NCT03161483|182881463|SUPERIORITY||Stratified difference|5.0||||0.512|TWO_SIDED|95.0|-9.77|19.48|||Cochran-Mantel-Haenszel|||||19.48|-9.77|0.512
91532166|NCT04770220|182940876|OTHER||Least Squares Mean Difference|2821.027|STANDARD_ERROR_OF_MEAN|1366.533||0.04|TWO_SIDED|||||Nominal p-value|MMRM||ALZ-801 minus placebo|Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.||||0.0400
91505767|NCT03161483|182881463|SUPERIORITY||Stratified difference|19.4||||0.011|TWO_SIDED|95.0|4.12|33.42|||Cochran-Mantel-Haenszel|||||33.42|4.12|0.011
91505768|NCT03161483|182881464|SUPERIORITY||Stratified difference|10.3||||0.264|TWO_SIDED|95.0|-7.66|27.97|||Cochran-Mantel-Haenszel|||||27.97|-7.66|0.264
91505769|NCT03161483|182881464|SUPERIORITY||Stratified difference|6.5||||0.399|TWO_SIDED|95.0|-8.45|21.0|||Cochran-Mantel-Haenszel|||||21.00|-8.45|0.399
91505770|NCT03161483|182881464|SUPERIORITY||Stratified difference|19.3||||0.012|TWO_SIDED|95.0|4.01|33.36|||Cochran-Mantel-Haenszel|||||33.36|4.01|0.012
91505771|NCT03161483|182881465|SUPERIORITY||Stratified difference|24.0||||0.446|TWO_SIDED|95.0|-12.38|53.11|||Cochran-Mantel-Haenszel|||||53.11|-12.38|0.446
91505772|NCT03161483|182881465|SUPERIORITY||Stratified difference|5.3|||>|0.999|TWO_SIDED|95.0|-27.64|39.38|||Cochran-Mantel-Haenszel|||||39.38|-27.64|>0.999
91505773|NCT03161483|182881465|SUPERIORITY||Stratified difference|14.2||||0.488|TWO_SIDED|95.0|-19.54|44.48|||Cochran-Mantel-Haenszel|||||44.48|-19.54|0.488
91505774|NCT03161483|182881466|SUPERIORITY||Stratified difference|12.4||||0.092|TWO_SIDED|95.0|-2.74|24.07|||Cochran-Mantel-Haenszel|||||24.07|-2.74|0.092
91505775|NCT03161483|182881466|SUPERIORITY||Stratified difference|-5.3||||0.434|TWO_SIDED|95.0|-18.43|8.06|||Cochran-Mantel-Haenszel|||||8.06|-18.43|0.434
91505776|NCT03161483|182881466|SUPERIORITY||Stratified difference|8.0||||0.182|TWO_SIDED|95.0|-3.88|19.65|||Cochran-Mantel-Haenszel|||||19.65|-3.88|0.182
91505777|NCT03161483|182881467|SUPERIORITY||Stratified difference|12.1||||0.098|TWO_SIDED|95.0|-2.98|23.78|||Cochran-Mantel-Haenszel|||||23.78|-2.98|0.098
91505778|NCT03161483|182881467|SUPERIORITY||Stratified difference|-4.3||||0.521|TWO_SIDED|95.0|-17.36|8.92|||Cochran-Mantel-Haenszel|||||8.92|-17.36|0.521
91505779|NCT03161483|182881467|SUPERIORITY||Stratified difference|6.8||||0.267|TWO_SIDED|95.0|-5.24|18.55|||Cochran-Mantel-Haenszel|||||18.55|-5.24|0.267
91505780|NCT03161483|182881468|SUPERIORITY||Difference in adjusted mean|0.7||||0.116|TWO_SIDED|95.0|-0.2|1.5|||longitudinal data analysis model|||||1.5|-0.2|0.116
91505781|NCT03161483|182881468|SUPERIORITY||Difference in adjusted mean|0.7||||0.094|TWO_SIDED|95.0|-0.1|1.6|||longitudinal data analysis model|||||1.6|-0.1|0.094
91505782|NCT03161483|182881468|SUPERIORITY||Difference in adjusted mean|0.1||||0.881|TWO_SIDED|95.0|-0.6|0.8|||longitudinal data analysis model|||||0.8|-0.6|0.881
91505783|NCT03161483|182881469|SUPERIORITY||Difference in adjusted mean|1.1||||0.16|TWO_SIDED|95.0|-0.4|2.6|||longitudinal data analysis model|||||2.6|-0.4|0.160
91505784|NCT03161483|182881469|SUPERIORITY||Difference in adjusted mean|1.3||||0.056|TWO_SIDED|95.0|0.0|2.6|||longitudinal data analysis model|||||2.6|0.0|0.056
91505785|NCT03161483|182881469|SUPERIORITY||Difference in adjusted mean|0.3||||0.621|TWO_SIDED|95.0|-1.0|1.6|||longitudinal data analysis model|||||1.6|-1.0|0.621
91505786|NCT03161483|182881471|SUPERIORITY||Difference in adjusted mean|-1.1||||0.546|TWO_SIDED|95.0|-4.7|2.5|||longitudinal data analysis model|||||2.5|-4.7|0.546
91505787|NCT03161483|182881471|SUPERIORITY||Difference in adjusted mean|-0.6||||0.681|TWO_SIDED|95.0|-3.7|2.4|||longitudinal data analysis model|||||2.4|-3.7|0.681
91505788|NCT03161483|182881471|SUPERIORITY||Difference in adjusted mean|1.4||||0.35|TWO_SIDED|95.0|-1.6|4.4|||longitudinal data analysis model|||||4.4|-1.6|0.350
91505789|NCT03161483|182881472|SUPERIORITY|\<= 7.5 mg/day|Stratified difference|0.2|||>|0.999|TWO_SIDED|95.0|-15.13|15.91|||longitudinal data analysis model|||||15.91|-15.13|>0.999
91505790|NCT03161483|182881472|SUPERIORITY|\< 10 mg/day|Stratified difference|-3.2|||>|0.999|TWO_SIDED|95.0|-17.74|13.0|||longitudinal data analysis model|||||13.00|-17.74|>0.999
91505791|NCT03161483|182881473|SUPERIORITY||Difference in adjusted means|2.8||||0.535|TWO_SIDED|95.0|-6.0|11.6|||longitudinal data analysis model|||||11.6|-6.0|0.535
91532167|NCT04770220|182940877|OTHER||Least Squares Mean Difference|-1157.0|STANDARD_ERROR_OF_MEAN|367.0||0.0018|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0018
91505792|NCT03161483|182881473|SUPERIORITY||Difference in adjusted means|4.2||||0.309|TWO_SIDED|95.0|-3.9|12.2|||longitudinal data analysis model|||||12.2|-3.9|0.309
91505793|NCT03161483|182881473|SUPERIORITY||Difference in adjusted means|6.5||||0.091|TWO_SIDED|95.0|-1.0|14.1|||longitudinal data analysis model|||||14.1|-1.0|0.091
91505794|NCT02767427|182881476|EQUIVALENCE|An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.|||||<|0.05|||||||t-test, 1 sided|Two one-sided t-tests were conducted with 18 in each group.||||||<0.05
91505795|NCT04753164|182881508|OTHER|Mixed effects model for Repeated Measures: Change from baseline in the number of BE days per week = baseline number of BE days per week + sex (Male; Female) + BMI group (\< 30 ; ≥ 30 kg/m2) + treatment + visit + treatment × visit + baseline × visit.|LS Mean Difference to Placebo|0.0||||0.9992|TWO_SIDED|95.0|-0.69|0.69|||Mixed effects model f. repeated measures|||||0.69|-0.69|0.9992
91505796|NCT00694369|182881509|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|"Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value~for 120-mg dose comparison is significant)."||||||<0.001
91505797|NCT00694369|182881509|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
91505798|NCT00694369|182881509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.06||||||95.0|-1.37|1.48|||||Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)|||1.48|-1.37|
91505799|NCT00694369|182881509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.43||||||95.0|-0.73|1.6|||||Difference in LS Means (etoricoxib minus ibuprofen)|||1.60|-0.73|
91505800|NCT00694369|182881509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.|Difference in LS Means|3.9||||||95.0|2.04|5.76|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.76|2.04|
91505801|NCT00694369|182881509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.|Difference in LS Means|4.27||||||95.0|2.61|5.94|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.94|2.61|
91532168|NCT04770220|182940878|OTHER||Least Squares Mean Difference|-0.0000214|STANDARD_ERROR_OF_MEAN|0.00000111||0.054|TWO_SIDED|95.0|-0.0000432|0.00000037||Nominal p-value|MMRM||ALZ-801 minus placebo|Analysis of the DTI-MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \> 65 years), gender, disease severity based on baseline MMSE, baseline DTI-MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.||0.00000037|-0.0000432|0.054
91750435|NCT02014480|183393536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.086|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.086|<0.001
91505802|NCT00694369|182881509|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.38||||||95.0|-1.8|1.05|||||Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)|||1.05|-1.80|
91505803|NCT00694369|182881509|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|10.59||||||95.0|8.72|12.47|||||Difference in LS Means (ibuprofen 2400 mg minus placebo)|||12.47|8.72|
91505804|NCT00694369|182881509|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.75||||||95.0|4.53|8.97|||||Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)|||8.97|4.53|
91505805|NCT00694369|182881510|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).||||||<0.001
91505806|NCT00694369|182881510|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
91505807|NCT00694369|182881510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.||||||0.161
91505808|NCT00694369|182881510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.014
91505809|NCT00694369|182881510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.007
91505810|NCT01405963|182881530|OTHER||Treatment Difference|7.65||||0.09|TWO_SIDED|95.0|-1.3|16.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||16.60|-1.30|0.09
91532169|NCT04770220|182940879|OTHER||Least Squares Mean Difference|-0.0000228|STANDARD_ERROR_OF_MEAN|0.00000829||0.0064|TWO_SIDED|95.0|-0.0000391|-0.0000065||Nominal p-value|MMRM|||||-0.0000065|-0.0000391|0.0064
91532170|NCT04770220|182940880|OTHER||Least Squares Mean Difference|0.009455|STANDARD_ERROR_OF_MEAN|0.00472||0.0465|TWO_SIDED|95.0|0.0001469|0.01876||Nominal p-value|MMRM|||||0.01876|0.0001469|0.0465
91750436|NCT02014480|183393536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.04|0.125||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.125|0.040|<0.001
91505811|NCT01405963|182881530|OTHER||Treatment Difference|9.91||||0.02|TWO_SIDED|95.0|1.59|18.23|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||18.23|1.59|0.02
91505812|NCT01405963|182881531|OTHER||Treatment Difference|-4.35||||0.11|TWO_SIDED|95.0|-9.8|1.1|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||1.10|-9.80|0.11
91505813|NCT01405963|182881531|OTHER||Treatment Difference|-4.66||||0.07|TWO_SIDED|95.0|-9.71|0.39|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.39|-9.71|0.07
91505814|NCT01405963|182881535|OTHER||Treatment Difference|8.57||||0.05|TWO_SIDED|95.0|0.01|17.13|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||17.13|0.01|0.05
91505815|NCT01405963|182881535|OTHER||Treatment Difference|10.27||||0.06|TWO_SIDED|95.0|-0.46|21.0|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||21.00|-0.46|0.06
91505816|NCT01405963|182881536|OTHER||Treatment Difference|-6.08||||0.03|TWO_SIDED|95.0|-11.56|-0.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.60|-11.56|0.03
91505817|NCT01405963|182881536|OTHER||Treatment Difference|-7.44||||0.03|TWO_SIDED|95.0|-14.22|-0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.66|-14.22|0.03
91505818|NCT01405963|182881537|OTHER||Treatment Difference|0.33||||0.05|TWO_SIDED|95.0|-0.01|0.68|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.68|-0.01|0.05
91505819|NCT01405963|182881537|OTHER||Treatment Difference|0.39||||0.08|TWO_SIDED|95.0|-0.06|0.84|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.84|-0.06|0.08
91532171|NCT04770220|182940881|OTHER||Least Squares Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|1.05||0.0416|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0416
91750437|NCT02014480|183393536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||<|0.001|TWO_SIDED|95.0|0.036|0.12||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.120|0.036|<0.001
91750438|NCT02014480|183393536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.008|TWO_SIDED|95.0|0.015|0.099||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.099|0.015|0.008
91750439|NCT01865812|183393545|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.51|-0.24||||||||-0.24|-0.51|
91750440|NCT01865812|183393546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||||-0.25|-0.63|
91750441|NCT01865812|183393547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-1.58|1.46||||||||1.46|-1.58|
91532172|NCT04770220|182940882|OTHER||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|1.02||0.3945|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.3945
91750442|NCT01865812|183393598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.852|||||||ANCOVA|||||||0.852
91750443|NCT01865812|183393599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549|||||||ANCOVA|||||||0.549
91750444|NCT01865812|183393600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912|||||||ANCOVA|||||||0.912
91505820|NCT01405963|182881538|OTHER||Treatment Difference|0.28||||0.03|TWO_SIDED|95.0|0.03|0.53|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.53|0.03|0.03
91505821|NCT01405963|182881538|OTHER||Treatment Difference|0.33||||0.06|TWO_SIDED|95.0|-0.01|0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.66|-0.01|0.06
91505822|NCT01405963|182881539|OTHER||Treatment Difference|0.41||||0.01|TWO_SIDED|95.0|0.12|0.7|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.70|0.12|0.01
91505823|NCT01405963|182881539|OTHER||Treatment Difference|0.42||||0.01|TWO_SIDED|95.0|0.11|0.72|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.72|0.11|0.01
91505824|NCT01405963|182881540|OTHER||Treatment Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.45|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.45|0.04|0.02
91505825|NCT01405963|182881540|OTHER||Treatment Difference|0.18||||0.15|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.44|-0.07|0.15
91505826|NCT04007523|182881570|OTHER|Fisher's Exact Test||||||0.653|||||||Fisher Exact|||||||0.653
91505827|NCT04007523|182881570|OTHER|Fisher's Exact Test||||||0.614|||||||Fisher Exact|||||||0.614
91505828|NCT04007523|182881570|OTHER|Fisher's Exact Test||||||0.999|||||||Fisher Exact|||||||0.999
91505829|NCT01826487|182881592|OTHER||Mean Difference (Final Values)|12.98|STANDARD_ERROR_OF_MEAN|10.415||0.213|TWO_SIDED|95.0|-7.44|33.39||Threshold for significance at 0.05. Secondary endpoints were tested for significance, only if the primary endpoint was statistically significant.|Mixed Models Analysis|||Analysis was performed using analysis of covariance (ANCOVA) method including stratification factors for age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years), duration of use of corticosteroids at baseline (approx. \>=6 to \<12 months vs. \>=12 months), and baseline 6MWD category (\>=350 meters vs \<350 meters), as well as baseline 6MWD as covariate.||33.39|-7.44|0.213
91750445|NCT01819129|183393601|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.15|0.1|||||The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).|Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.10|-0.15|
91505830|NCT01408030|182881603|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.97|||||||ANOVA|||||||0.97
91505831|NCT01408030|182881604|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.47|||||||ANOVA|||||||.47
91505832|NCT01408030|182881605|OTHER|Two sided testing was performed with a significance level of 0.05.|||||<|0.001||||||"A mixed-model repeated-measures ANOVA was used to analyze ESS for drug and time (baseline, week 12) effects.~Listed P value is for time effect."|Mixed Models Analysis|Clinical site and patient were included in the model as random effects.||||||<0.001
91505833|NCT01408030|182881606|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.43|||||||ANCOVA|Adjusted for baseline values and random effect of clinic site.||||||0.43
91505834|NCT01408030|182881607|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.42|||||||Fisher Exact|||||||0.42
91505835|NCT01408030|182881608|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.08|||||||Fisher Exact|||||||0.08
91505836|NCT03608774|182881611|SUPERIORITY||Risk Difference (RD)|0.26|||<|0.001|TWO_SIDED|95.0|0.16|0.36||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. P-value was derived using stage-wise ordering of the sample space.|Chi-squared||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. Estimates were derived using stage-wise ordering of the sample space.|||0.36|0.16|<0.001
91505837|NCT03608774|182881612|OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|0.0|0.22||||||||0.22|0.00|
91505838|NCT03608774|182881613|OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.01|0.21||||||||0.21|-0.01|
91505839|NCT03608774|182881614|OTHER||Risk Difference (RD)|0.26|||||TWO_SIDED|95.0|0.15|0.38||||||||0.38|0.15|
91505840|NCT03608774|182881615|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
91505841|NCT03608774|182881616|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
91532173|NCT04770220|182940883|OTHER||Least Squares Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|3.07||0.2682|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.2682
91750446|NCT02752958|183393605|OTHER||Mean Difference (Final Values)|5.89||||0.0944|TWO_SIDED|95.0|-1.018|12.8|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (Baseline ) versus (vs.) Week 4||12.80|-1.018|0.0944
91750447|NCT02752958|183393606|OTHER||Mean Difference (Final Values)|16.99|||<|0.0001|TWO_SIDED|95.0|10.128|23.849|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 8||23.849|10.128|<0.0001
91505842|NCT01586819|182881617|SUPERIORITY||Z score|-3.3902||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.||||.002
91505843|NCT01586819|182881618|SUPERIORITY||Z score|3.6115||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.||||.001
91505844|NCT00004888|182881645|SUPERIORITY_OR_OTHER||Overall Response Rate|0.474|||||TWO_SIDED|95.0|0.31|0.642||||||||0.642|0.31|
91505845|NCT00004888|182881645|SUPERIORITY_OR_OTHER||Overall Response Rate|0.457|||||TWO_SIDED|95.0|0.309|0.61||||||||0.61|0.309|
91505846|NCT00136084|182881650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.624||||0.1559||95.0|0.832|3.205||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.|The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.|The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.||3.205|.832|.1559
91505847|NCT00136084|182881651|SUPERIORITY_OR_OTHER||Binomial proportion|0.733||||||95.0|0.449|0.922|||Binomial proportion|||Estimate of the proportion of negative minimal residual disease.||.922|.449|
91505848|NCT00136084|182881652|SUPERIORITY_OR_OTHER||Binomial proportion|0.931||||||95.0|0.772|0.992|||Binomial proportion|||||.992|.772|
91505849|NCT00136084|182881653|SUPERIORITY_OR_OTHER||Binomial proportion|0.9||||||95.0|0.735|0.979|||Binomial proportion|||||.979|.735|
91505850|NCT00136084|182881655|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
91505851|NCT00136084|182881656|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.0139||||0.2287|TWO_SIDED|95.0|-0.0365|0.00873|||Regression, Logistic|||||0.00873|-0.0365|0.2287
91505852|NCT02174848|182881674|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone.||||0.0500
91505853|NCT02174848|182881674|SUPERIORITY|||||||0.9781|||||||t-test, 2 sided|||This comparison is for the extension study, during which patients in both groups received deferiprone.||||0.9781
91505854|NCT02174848|182881675|SUPERIORITY|||||||0.0206|||||||paired t-test|||||||0.0206
91505855|NCT02174848|182881676|SUPERIORITY|||||||0.2684|||||||paired t-test|||||||0.2684
91532174|NCT04770220|182940884|OTHER||Least Squares Mean Difference|3.66|STANDARD_ERROR_OF_MEAN|2.96||0.2178|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.2178
91750448|NCT02752958|183393607|OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|15.87|29.539|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 12||29.539|15.870|<0.0001
91532175|NCT04770220|182940885|OTHER||Least Squares Mean Difference|-0.646|STANDARD_ERROR_OF_MEAN|0.333||0.0533|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0533
91532176|NCT04770220|182940886|OTHER||Least Squares Mean Difference|0.127|STANDARD_ERROR_OF_MEAN|0.314||0.6854|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.6854
91505856|NCT02174848|182881677|SUPERIORITY|||||||0.0821|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone||||0.0821
91505857|NCT02174848|182881677|SUPERIORITY|||||||0.5885|||||||t-test, 2 sided|||For the placebo-DFP group, the comparison is of the scores at the start vs. the end of the extension study; for the DFP-DFP group, the comparison is of the scores at the start vs. the end of the initial study||||0.5885
91505858|NCT02174848|182881678|SUPERIORITY|||||||0.3306|||||||t-test, 2 sided|||||||0.3306
91505859|NCT00218296|182881789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.04|TWO_SIDED|95.0|0.26|0.99|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.99|0.26|0.04
91505860|NCT00218296|182881790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||0.019|TWO_SIDED|95.0|0.07|0.83|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.83|0.07|0.019
91505861|NCT00218296|182881791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.03|TWO_SIDED|95.0|0.18|0.94|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.94|0.18|0.03
91505862|NCT00218296|182881792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|.002
91505863|NCT00218296|182881793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.056|TWO_SIDED|95.0|0.2|1.03|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||1.03|0.20|0.056
91505864|NCT00218296|182881794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48||There were no adjustments in the analysis.|Chi-squared||The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|0.002
91505865|NCT02623803|182881795|SUPERIORITY|||||||0.1459|||||||Wilcoxon (Mann-Whitney)|||||||0.1459
91505866|NCT02623803|182881796|SUPERIORITY|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.2050
91532177|NCT04770220|182940887|OTHER||Least Squares Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|2.52||0.0161|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0161
91532178|NCT04770220|182940888|OTHER||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|2.51||0.8387|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.8387
91505867|NCT02623803|182881797|SUPERIORITY|||||||0.3989|||||||Wilcoxon (Mann-Whitney)|||||||0.3989
91505868|NCT02623803|182881798|SUPERIORITY|||||||0.5285|||||||Wilcoxon (Mann-Whitney)|||||||0.5285
91505869|NCT02623803|182881799|SUPERIORITY|||||||0.0697|||||||Wilcoxon (Mann-Whitney)|||||||0.0697
91505870|NCT02623803|182881800|SUPERIORITY|||||||0.1029|||||||Wilcoxon (Mann-Whitney)|||||||0.1029
91505871|NCT02623803|182881801|SUPERIORITY|||||||0.3136|||||||Wilcoxon (Mann-Whitney)|||||||0.3136
91505872|NCT02623803|182881802|SUPERIORITY|||||||0.2196|||||||Wilcoxon (Mann-Whitney)|||||||0.2196
91505873|NCT02623803|182881803|SUPERIORITY|||||||0.3057|||||||Wilcoxon (Mann-Whitney)|||||||0.3057
91505874|NCT02623803|182881804|SUPERIORITY|||||||0.0404|||||||Wilcoxon (Mann-Whitney)|||||||0.0404
91505875|NCT02623803|182881805|SUPERIORITY|||||||0.5314|||||||Wilcoxon (Mann-Whitney)|||||||0.5314
91505876|NCT02623803|182881806|SUPERIORITY|||||||0.3166|||||||Wilcoxon (Mann-Whitney)|||||||0.3166
91505877|NCT02623803|182881807|SUPERIORITY|||||||0.2363|||||||Wilcoxon (Mann-Whitney)|||||||0.2363
91505878|NCT02623803|182881808|SUPERIORITY|||||||0.9171|||||||Wilcoxon (Mann-Whitney)|||||||0.9171
91505879|NCT02623803|182881809|SUPERIORITY|||||||0.4194|||||||Wilcoxon (Mann-Whitney)|||||||0.4194
91505880|NCT02623803|182881810|SUPERIORITY|||||||0.7073|||||||Wilcoxon (Mann-Whitney)|||||||0.7073
91505881|NCT02623803|182881811|SUPERIORITY|||||||0.5107|||||||Wilcoxon (Mann-Whitney)|||||||0.5107
91505882|NCT02623803|182881812|SUPERIORITY|||||||0.8339|||||||Wilcoxon (Mann-Whitney)|||||||0.8339
91505883|NCT02623803|182881813|SUPERIORITY|||||||0.8927|||||||Wilcoxon (Mann-Whitney)|||||||0.8927
91505884|NCT04452331|182881816|SUPERIORITY|||||||0.06|||||||Regression, Linear|Adjusted for clinical site||Diastolic BP||||0.06
91505885|NCT04452331|182881816|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Systolic BP||||0.90
91505886|NCT04452331|182881818|SUPERIORITY|||||||0.29|||||||Regression, Linear|||||||.29
91505887|NCT04452331|182881819|SUPERIORITY|||||||0.1|||||||Regression, Logistic|||||||.10
91505888|NCT04452331|182881820|SUPERIORITY|||||||0.44|||||||Regression, Linear|||||||0.44
91532179|NCT04770220|182940889|OTHER||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.5||0.0795|TWO_SIDED|95.0|-0.103|1.845||Nominal p-value|MMRM|||||1.845|-0.103|0.0795
91532180|NCT04770220|182940890|OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8169|TWO_SIDED|95.0|-1.07|0.845||Nominal p-value|MMRM|||||0.845|-1.070|0.8169
91532181|NCT04770220|182940891|OTHER||Least Squares Mean Difference|108.1|STANDARD_ERROR_OF_MEAN|37.46||0.0042|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0042
91505889|NCT04452331|182881821|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||0.01
91750449|NCT02752958|183393608|OTHER||Mean Difference (Final Values)|27.21|||<|0.0001|TWO_SIDED|95.0|20.245|34.165|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 16||34.165|20.245|<0.0001
91505890|NCT04452331|182881822|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.01
91505891|NCT04452331|182881823|SUPERIORITY|||||||0.54|||||||Regression, negative binomial|||||||0.54
91505892|NCT04452331|182881824|SUPERIORITY|||||||0.74|||||||Regression, negative binomial|||||||0.74
91505893|NCT04452331|182881825|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
91505894|NCT04452331|182881825|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
91505895|NCT04452331|182881826|SUPERIORITY||||||<|0.001|||||||Regression, negative binomial|||||||<0.001
91505896|NCT04452331|182881826|SUPERIORITY|||||||0.03|||||||Regression, negative binomial|||||||0.03
91505897|NCT04452331|182881827|SUPERIORITY||||||<|0.001|||||||Regression, poisson|||||||<0.001
91505898|NCT04452331|182881827|SUPERIORITY|||||||0.08|||||||Regression, poisson|||||||0.08
91505899|NCT04452331|182881828|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||<.001
91750450|NCT02752958|183393609|OTHER||Mean Difference (Final Values)|31.42|||<|0.0001|TWO_SIDED|95.0|24.464|38.385|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||38.385|24.464|<.0001
91750451|NCT02752958|183393610|OTHER||Mean Difference (Final Values)|32.55|||<|0.0001|TWO_SIDED|95.0|25.585|39.506|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 24||39.506|25.585|<.0001
91750452|NCT02752958|183393611|OTHER||Mean Difference (Final Values)|1.18||||0.0312|TWO_SIDED|95.0|0.108|2.262|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 4||2.262|0.108|0.0312
91750453|NCT02752958|183393612|OTHER||Mean Difference (Final Values)|2.8|||<|0.0001|TWO_SIDED|95.0|1.728|3.866|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||3.866|1.728|<.0001
91750454|NCT02752958|183393613|OTHER||Mean Difference (Final Values)|3.26|||<|0.0001|TWO_SIDED|95.0|2.192|4.322|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||4.322|2.192|<.0001
91750455|NCT02752958|183393614|OTHER||Mean Difference (Final Values)|3.93|||<|0.0001|TWO_SIDED|95.0|2.844|5.012|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||5.012|2.844|<.0001
91750456|NCT02752958|183393615|OTHER||Mean Difference (Final Values)|4.15|||<|0.0001|TWO_SIDED|95.0|3.063|5.232|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||5.232|3.063|<.0001
91750457|NCT02752958|183393616|OTHER||Mean Difference (Final Values)|4.74|||<|0.0001|TWO_SIDED|95.0|3.654|5.823|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.823|3.654|<.0001
91505900|NCT04452331|182881828|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||0.98
91505901|NCT04452331|182881829|SUPERIORITY|||||||0.2|||||||Regression, Linear|||Systolic BP||||0.20
91505902|NCT04452331|182881829|SUPERIORITY|||||||0.82|||||||Regression, Linear|||Systolic BP||||0.82
91505903|NCT04452331|182881829|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Diastolic BP||||0.12
91505904|NCT04452331|182881829|SUPERIORITY|||||||0.1|||||||Regression, Linear|||Diastolic BP||||0.10
91505905|NCT04064294|182881830|SUPERIORITY|||||||0.63||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.63
91505906|NCT04064294|182881831|SUPERIORITY|||||||0.09||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.09
91505907|NCT04064294|182881832|SUPERIORITY|||||||0.011|||||||Chi-squared|threshold for significance is 0.05, degrees of freedom = 2||||||0.011
91505908|NCT04064294|182881833|SUPERIORITY|||||||0.033|||||||ANOVA|degrees of freedom = 75||||||0.033
91505909|NCT01289847|182881835|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||one-sample Poisson rate|||For the primary efficacy analysis, the SABI rate for GAMMAPLEX and the upper bound of its one-sided 99% confidence interval (CI) were estimated by using the exact method for a one-sample Poisson rate.||||0.01
91505910|NCT01289847|182881836|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|99.0|||||one-sample Poisson method|||||||0.01
91505911|NCT04534764|182881845|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.039|0.006|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|High Luminance Low Contrast||0.006|-0.039|
91505912|NCT04534764|182881845|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.014|0.031|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|Low Luminance High Contrast||0.031|-0.014|
91505913|NCT03556579|182882003|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.01|-0.36|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.36|-1.01|
91505914|NCT03556579|182882003|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.45|-0.81|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.81|-1.45|
91505915|NCT03556579|182882004|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-8.86|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-13.16|-4.55|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-4.55|-13.16|
91532182|NCT04770220|182940892|OTHER||Least Squares Mean Difference|51.3|STANDARD_ERROR_OF_MEAN|32.42||0.1145|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.1145
91532183|NCT04770220|182940893|OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.005|<|0.0001|TWO_SIDED|||||Nominal p-value|MMRM|||||||< 0.0001
91750458|NCT02752958|183393617|OTHER||Mean Difference (Final Values)|1.11||||0.4185|TWO_SIDED|95.0|-1.592|3.821|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 4||3.821|-1.592|0.4185
91750459|NCT02752958|183393618|OTHER||Mean Difference (Final Values)|7.08|||<|0.0001|TWO_SIDED|95.0|4.391|9.764|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||9.764|4.391|<.0001
91505916|NCT03556579|182882004|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-24.93|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-29.24|-20.62|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-20.62|-29.24|
91505917|NCT03556579|182882005|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.15|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.15|
91750460|NCT02752958|183393619|OTHER||Mean Difference (Final Values)|8.35|||<|0.0001|TWO_SIDED|95.0|5.674|11.026|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 12||11.026|5.674|<.0001
91750461|NCT02752958|183393620|OTHER|Week 0 Vs Week 16|Mean Difference (Final Values)|10.43|||<|0.0001|TWO_SIDED|95.0|7.708|13.158|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||13.158|7.708|<.0001
91750462|NCT02752958|183393621|OTHER||Mean Difference (Final Values)|11.73|||<|0.0001|TWO_SIDED|95.0|9.008|14.459|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||14.459|9.008|<.0001
91750463|NCT02752958|183393622|OTHER||Mean Difference (Final Values)|11.96|||<|0.0001|TWO_SIDED|95.0|9.235|14.686|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||14.686|9.235|<.0001
91750464|NCT02752958|183393623|OTHER||Mean Difference (Final Values)|0.57||||0.3415|TWO_SIDED|95.0|-0.604|1.738|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 4||1.738|-0.604|0.3415
91750465|NCT02752958|183393624|OTHER||Mean Difference (Final Values)|1.77||||0.0029|TWO_SIDED|95.0|0.61|2.935|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 8||2.935|0.610|0.0029
91750466|NCT02752958|183393625|OTHER||Mean Difference (Final Values)|2.42|||<|0.0001|TWO_SIDED|95.0|1.266|3.582|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||3.582|1.266|<0.0001
91532184|NCT04770220|182940894|OTHER||Least Squares Mean Difference|0.007|STANDARD_ERROR_OF_MEAN|0.004||0.0985|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0985
91532185|NCT04770220|182940895|OTHER||Least Squares Mean Difference|0.033|STANDARD_ERROR_OF_MEAN|0.009||0.0002|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0002
91532186|NCT04770220|182940896|OTHER||Least Squares Mean Difference|0.014|STANDARD_ERROR_OF_MEAN|0.008||0.0699|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0699
91750467|NCT02752958|183393626|OTHER||Mean Difference (Final Values)|3.55|||<|0.0001|TWO_SIDED|95.0|2.371|4.729|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||4.729|2.371|<.0001
91532187|NCT04770220|182940897|OTHER||Least Squares Mean Difference|3843.824|STANDARD_ERROR_OF_MEAN|1726.729||0.0267|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0267
91750468|NCT02752958|183393627|OTHER||Mean Difference (Final Values)|4.39|||<|0.0001|TWO_SIDED|95.0|3.21|5.568|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||5.568|3.210|<0.0001
91750469|NCT02752958|183393628|OTHER||Mean Difference (Final Values)|4.3|||<|0.0001|TWO_SIDED|95.0|3.119|5.477|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.477|3.119|<0.0001
91532188|NCT04770220|182940898|OTHER||Least Squares Mean Difference|2164.299|STANDARD_ERROR_OF_MEAN|1457.282||0.1386|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.1386
91750470|NCT02752958|183393629|OTHER||Mean Difference (Final Values)|2.42||||0.0145|TWO_SIDED|95.0|0.483|4.352|||ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||4.352|0.483|0.0145
91750471|NCT02752958|183393630|OTHER||Mean Difference (Final Values)|4.42|||<|0.0001|TWO_SIDED|95.0|2.498|6.339|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||6.339|2.498|<0.0001
91750472|NCT02752958|183393631|OTHER||Mean Difference (Final Values)|6.85|||<|0.0001|TWO_SIDED|95.0|4.933|8.759|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||8.759|4.933|<0.0001
91750473|NCT02752958|183393632|OTHER||Mean Difference (Final Values)|7.17|||<|0.0001|TWO_SIDED|95.0|5.219|9.115|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||9.115|5.219|<.0001
91750474|NCT02752958|183393633|OTHER||Mean Difference (Final Values)|8.39|||<|0.0001|TWO_SIDED|95.0|6.438|10.335|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||10.335|6.438|<0.0001
91750475|NCT02752958|183393634|OTHER||Mean Difference (Final Values)|8.67|||<|0.0001|TWO_SIDED|95.0|6.726|10.623|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 24||10.623|6.726|<0.0001
91750476|NCT02752958|183393635|OTHER||Mean Difference (Final Values)|0.63||||0.3676|TWO_SIDED|95.0|-0.738|1.989|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.989|-0.738|0.3676
91750477|NCT02752958|183393636|OTHER||Mean Difference (Final Values)|0.9||||0.1907|TWO_SIDED|95.0|-0.451|2.255|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||2.255|-0.451|0.1907
91750478|NCT02752958|183393637|OTHER||Mean Difference (Final Values)|1.81||||0.0085|TWO_SIDED|95.0|0.467|3.162|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||3.162|0.467|0.0085
91750479|NCT02752958|183393638|OTHER||Mean Difference (Final Values)|2.12||||0.0026|TWO_SIDED|95.0|0.744|3.489|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||3.489|0.744|0.0026
91750480|NCT02752958|183393639|OTHER||Mean Difference (Final Values)|2.74||||0.0001|TWO_SIDED|95.0|1.371|4.116|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||4.116|1.371|0.0001
91532189|NCT04770220|182940899|OTHER||Least Squares Mean Difference|-1312.0|STANDARD_ERROR_OF_MEAN|437.0||0.0029|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0029
91532190|NCT04770220|182940900|OTHER||Least Squares Mean Difference|-1057.0|STANDARD_ERROR_OF_MEAN|386.0||0.0065|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.0065
91505918|NCT03556579|182882006|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Ratio|0.55|||||TWO_SIDED|95.0|0.46|0.65|||Generalized linear mixed model|Generalized Linear mixed model with a lognormal distribution using the Kenward and Roger method for the denominator degrees of freedom.||||0.65|0.46|
91505919|NCT03556579|182882007|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.07|-0.15|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||-0.15|-1.07|
91750481|NCT02752958|183393640|OTHER||Mean Difference (Final Values)|2.85|||<|0.0001|TWO_SIDED|95.0|1.477|4.222|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 24||4.222|1.477|<.0001
91750482|NCT02752958|183393641|OTHER||Mean Difference (Final Values)|0.09||||0.2326|TWO_SIDED|95.0|-0.059|0.243|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 4||0.243|-0.059|0.2326
91750483|NCT02752958|183393642|OTHER||Mean Difference (Final Values)|0.07||||0.3934|TWO_SIDED|95.0|-0.085|0.216||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||0.216|-0.085|0.3934
91750484|NCT02752958|183393643|OTHER||Mean Difference (Final Values)|0.13||||0.0795|TWO_SIDED|95.0|-0.016|0.284|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||0.284|-0.016|0.0795
91750485|NCT02752958|183393644|OTHER||Mean Difference (Final Values)|0.14||||0.0682|TWO_SIDED|95.0|-0.011|0.294|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||0.294|-0.011|0.0682
91750486|NCT02752958|183393645|OTHER||Mean Difference (Final Values)|0.13||||0.0844|TWO_SIDED|95.0|-0.018|0.287|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||0.287|-0.018|0.0844
91750487|NCT02752958|183393646|OTHER||Mean Difference (Final Values)|0.18||||0.0211|TWO_SIDED|95.0|0.027|0.332|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 24||0.332|0.027|0.0211
91750488|NCT02752958|183393647|OTHER||Mean Difference (Final Values)|0.6||||0.0493|TWO_SIDED|95.0|0.002|1.194|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||1.194|0.002|0.0493
91750489|NCT02752958|183393648|OTHER||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|0.83|2.013|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||2.013|0.830|<0.0001
91750490|NCT02752958|183393649|OTHER||Mean Difference (Final Values)|1.87|||<|0.0001|TWO_SIDED|95.0|1.278|2.457||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.457|1.278|<0.0001
91750491|NCT02752958|183393650|OTHER||Mean Difference (Final Values)|2.03|||<|0.0001|TWO_SIDED|95.0|1.429|2.629|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||2.629|1.429|<.0001
91750492|NCT02752958|183393651|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||2.943|1.743|<.0001
91750493|NCT02752958|183393652|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.943|1.743|<.0001
91505920|NCT03556579|182882008|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.14|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.14|
91532191|NCT04770220|182940901|OTHER||Least Squares Mean Difference|149.8|STANDARD_ERROR_OF_MEAN|89.801||0.0966|TWO_SIDED|||||Nominal p-value|MMRM|||Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.||||0.0966
91532192|NCT04770220|182940902|OTHER||Least Squares Mean Difference|137.943|STANDARD_ERROR_OF_MEAN|112.257||0.22|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.2200
91532193|NCT04770220|182940903|OTHER||Least Squares Mean Difference|157.414|STANDARD_ERROR_OF_MEAN|95.523||0.1005|TWO_SIDED|||||Nominal p-value|MMRM|||||||0.1005
91532194|NCT04894903|182940910|OTHER||Odds Ratio (OR)|0.45|||<|0.001|TWO_SIDED|95.0|0.3|0.68||This is the calculated p-value. We used an alpha level of 0.05|Mixed Models Analysis|Adjusted for baseline number of gaps||||0.68|0.30|<0.001
91532195|NCT04894903|182940912|OTHER||Odds Ratio (OR)|0.57||||0.29|TWO_SIDED|95.0|0.2|1.62|||Mixed Models Analysis|||||1.62|0.20|0.29
91532196|NCT04894903|182940913|OTHER||beta coefficient|-0.04||||0.74|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||0.17|-0.24|0.74
91532197|NCT04894903|182940914|OTHER||beta coefficient|-0.04||||0.88|TWO_SIDED|95.0|-0.6|0.51|||Mixed Models Analysis|||||0.51|-0.60|0.88
91532198|NCT04894903|182940915|OTHER||beta coefficient|-1.24||||0.21|TWO_SIDED|95.0|-3.19|0.71|||Mixed Models Analysis|||||0.71|-3.19|0.21
91532199|NCT04894903|182940918|OTHER||beta coefficient|0.47||||0.21|TWO_SIDED|95.0|-0.27|1.22|||Mixed Models Analysis|||||1.22|-0.27|0.21
91532200|NCT01923428|182940920|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91532201|NCT02550873|182940921|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|0.72||0.0014|TWO_SIDED|90.0|1.1|3.5||a priori threshold for statistical significance = 0.10|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||"The sample size calculation was based on the following assumptions:~Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80%"||3.5|1.1|0.0014
91532202|NCT02550873|182940922|SUPERIORITY||Mean Difference (Net)|31.3|STANDARD_ERROR_OF_MEAN|8.42||0.0002|TWO_SIDED|90.0|17.4|45.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||45.1|17.4|0.0002
91505921|NCT03556579|182882009|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-30.56|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-31.66|-25.46|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|||-25.46|-31.66|
91750494|NCT02752958|183393653|OTHER||Mean Difference (Final Values)|0.88|||<|0.0001|TWO_SIDED|95.0|0.474|1.295|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.295|0.474|<.0001
91750495|NCT02752958|183393654|OTHER||Mean Difference (Final Values)|1.28|||<|0.0001|TWO_SIDED|95.0|0.875|1.69|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.690|0.875|<.0001
91505922|NCT03556579|182882009|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-15.38|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-20.48|-10.27|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test Minus Control.|||-10.27|-20.48|
91505923|NCT00788827|182882017|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.||||<0.05
91750496|NCT02752958|183393655|OTHER||Mean Difference (Final Values)|1.74|||<|0.0001|TWO_SIDED|95.0|1.333|2.145|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.145|1.333|<.0001
91750497|NCT02752958|183393656|OTHER||Mean Difference (Final Values)|1.96|||<|0.0001|TWO_SIDED|95.0|1.545|2.371|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||2.371|1.545|<.0001
91750498|NCT02752958|183393657|OTHER||Mean Difference (Final Values)|2.06|||<|0.0001|TWO_SIDED|95.0|1.643|2.469|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.469|1.643|<.0001
91532203|NCT02550873|182940923|SUPERIORITY||Mean Difference (Net)|93.5|STANDARD_ERROR_OF_MEAN|72.98||0.2032|TWO_SIDED|90.0|-27.7|214.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||214.7|-27.7|0.2032
91750499|NCT02752958|183393658|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.794|2.62||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.620|1.794|<.0001
91750500|NCT02752958|183393659|OTHER||Mean Difference (Final Values)|1.18|||<|0.0001|TWO_SIDED|95.0|0.703|1.66|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.660|0.703|<0.0001
91750501|NCT02752958|183393660|OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.977|1.926|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.926|0.977|<.0001
91750502|NCT02752958|183393661|OTHER||Mean Difference (Final Values)|1.95|||<|0.0001|TWO_SIDED|95.0|1.473|2.418|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 12||2.418|1.473|<.0001
91750503|NCT02752958|183393662|OTHER||Mean Difference (Final Values)|2.33|||<|0.0001|TWO_SIDED|95.0|1.848|2.81|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week16||2.810|1.848|<.0001
91750504|NCT02752958|183393663|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.732|2.694|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.694|1.732|<.0001
91750505|NCT02752958|183393664|OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.02|2.982|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.982|2.020|<.0001
91750506|NCT02752958|183393665|OTHER||Mean Difference (Final Values)|0.43||||0.0786|TWO_SIDED|95.0|-0.05|0.919|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||0.919|-0.050|0.0786
91750507|NCT02752958|183393666|OTHER||Mean Difference (Final Values)|0.69||||0.005|TWO_SIDED|95.0|0.21|1.171|||ANOVA|\[1\] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||1.171|0.210|0.0050
91750508|NCT02752958|183393667|OTHER||Mean Difference (Final Values)|1.4|||<|0.0001|TWO_SIDED|95.0|0.918|1.875|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 12||1.875|0.918|<.0001
91750509|NCT02752958|183393668|OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.951|1.926|||ANOVA|\[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||1.926|0.951|<.0001
91505924|NCT04448210|182882034|SUPERIORITY||||||<|0.25|||||||ANOVA|||||||<.25
91505925|NCT04448210|182882035|SUPERIORITY|||||||0.72|||||||ANOVA|||||||.72
91505926|NCT04448210|182882036|SUPERIORITY|||||||0.16|||||||ANOVA|||||||.16
91505927|NCT04448210|182882037|SUPERIORITY|||||||0.43|||||||ANOVA|||||||.43
91505928|NCT04448210|182882038|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
91505929|NCT04448210|182882039|SUPERIORITY|||||||0.38|||||||ANOVA|||||||.38
91505930|NCT04448210|182882040|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
91505931|NCT04448210|182882041|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
91505932|NCT04448210|182882042|SUPERIORITY|||||||0.3|||||||ANOVA|||||||.30
91505933|NCT01324349|182882092|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||<|0.0001|||||||Log Rank||Median difference equals control median minus Hemostatic Patch median in minutes.|The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.||||<0.0001
91505934|NCT01324349|182882093|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.2||||0.0339|TWO_SIDED|95.0|1.9|47.3|||Suissa and Shuster test||Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.|The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.||47.3|1.9|0.0339
91750510|NCT02752958|183393669|OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.678|1.653||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||1.653|0.678|<.0001
91750511|NCT02752958|183393670|OTHER||Mean Difference (Final Values)|1.56|||<|0.0001|TWO_SIDED|95.0|1.072|2.047|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||2.047|1.072|<.0001
91750512|NCT02825966|183393671|EQUIVALENCE|The two one-sided t-test (TOST) was used to test equivalence. Using TOST, equivalence was established at α = 0.05 significance level if a (1-2α)\*100% confidence interval for the average difference in EMAT (WCD-AUDICOR) was contained within the interval \[-12, 12\].|Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|90.0|-2.89|4.69|||two one-sided test (TOST)|||First, the difference in EMAT between the LifeVest and AUDICOR device (first wear) was calculated for each subject. Then the mean and standard deviation of the differences in EMAT were calculated. The 2 devices were considered equivalent if the 90% confidence interval for mean difference in EMAT was within the pre-specified margin of \[-12, 12\] ms.||4.69|-2.89|< 0.001
91750513|NCT00977938|183393684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.59|0.85||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.85|0.59|<0.001
91750514|NCT00977938|183393685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.17|0.48||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.48|0.17|<0.001
91750515|NCT00977938|183393686|NON_INFERIORITY_OR_EQUIVALENCE|The primary safety analysis was a noninferiority analysis performed with the use of the Farrington-Manning risk-difference approach. Assuming an annualized rate for moderate or severe bleeding of 1.9% and an absolute noninferiority margin of 0.8%, at a one-sided alpha level of significance of 0.025, we calculated that a sample size of 9960 patients would give the study 80% power to detect noninferiority.|Risk Difference (RD)|0.96||||0.704|TWO_SIDED|95.0|0.38|1.53||One-sided P-value for non-inferiority|Farrington-Manning||30-month DAPT vs. 12-month DAPT|||1.53|0.38|0.704
91750516|NCT00977938|183393687|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.28% (0.0228)|Risk Difference (RD)|-1.82|||<|0.001|ONE_SIDED|97.5||0.03||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||0.03||<0.001
91750517|NCT00977938|183393688|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.97% (0.0097)|Risk Difference (RD)|-1.05|||<|0.001|ONE_SIDED|97.5||-0.27||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||-0.27||<0.001
91750518|NCT00977938|183393689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.7|0.97|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.97|0.70|
91750519|NCT00977938|183393690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.69|0.29|
91750520|NCT00977938|183393691|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|0.24|1.48|||||30-month DAPT vs. 12-month DAPT|||1.48|0.24|
91505935|NCT01324349|182882094|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.5||||0.5029|||||||Fisher Exact||Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.|The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.||||0.5029
91513412|NCT02328326|182898541|SUPERIORITY||Mean Difference (Net)|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19|||Regression, Linear|Model was adjusted for baseline value of PAID, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.||1.19|-0.95|0.83
91532204|NCT02550873|182940924|SUPERIORITY||Mean Difference (Net)|31.9|STANDARD_ERROR_OF_MEAN|46.33||0.4927|TWO_SIDED|90.0|-45.0|108.8||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||108.8|-45.0|0.4927
91532205|NCT02550873|182940925|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.96||0.5835|TWO_SIDED|90.0|-2.2|4.3||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||4.3|-2.2|0.5835
91532206|NCT02550873|182940926|SUPERIORITY||Mean Difference (Net)|43.6|STANDARD_ERROR_OF_MEAN|102.28||0.6707|TWO_SIDED|90.0|-126.3|213.5||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||213.5|-126.3|0.6707
91532207|NCT02550873|182940927|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.91||0.52|TWO_SIDED|90.0|-4.4|1.9||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||1.9|-4.4|0.52
91532208|NCT02550873|182940928|OTHER|Correlation analysis||||||0.0001||||||This study was not powered to test hypotheses beyond the primary endpoint.|Pearson's correlation|||||||0.0001
91532209|NCT02550873|182940928|OTHER|Correlation analysis||||||0.0069|||||||Pearson's correlation|||This study was not powered to test hypotheses beyond the primary endpoint.||||0.0069
91750521|NCT00977938|183393692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.722|TWO_SIDED|95.0|0.57|1.47||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.47|0.57|0.722
91532210|NCT02550873|182940929|SUPERIORITY|||||||0.4179||||||P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.4179
91532211|NCT02550873|182940929|SUPERIORITY|||||||0.2184||||||P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.2184
91532212|NCT02550873|182940930|SUPERIORITY|||||||0.7773||||||P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.7773
91532213|NCT02550873|182940930|SUPERIORITY|||||||0.5976||||||P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.5976
91532214|NCT02550873|182940931|SUPERIORITY|||||||0.29||||||P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.29
91532215|NCT02550873|182940932|SUPERIORITY|||||||0.0508||||||P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.0508
91532216|NCT02550873|182940933|SUPERIORITY|||||||0.6308||||||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.6308
91750522|NCT00977938|183393693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.478|TWO_SIDED|95.0|0.15|1.64||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.64|0.15|0.478
91505936|NCT00851799|182882095|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-4.7||||0.013|TWO_SIDED|97.5|-8.9|-0.4||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||-0.4|-8.9|0.013
91505937|NCT00851799|182882095|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-2.8||||0.15|TWO_SIDED|97.5|-7.0|1.5||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.5|-7.0|0.15
91505938|NCT00851799|182882095|SUPERIORITY_OR_OTHER||Difference in annual rate of change|1.9||||0.31|TWO_SIDED|97.5|-2.4|6.2||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||6.2|-2.4|0.31
91750523|NCT00977938|183393694|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.12||||0.706|TWO_SIDED|95.0|-0.06|2.31|||Farrington-Manning|No formal hypothesis testing was done.|30-month DAPT vs. 12-month DAPT|||2.31|-0.06|0.706
91750524|NCT00977938|183393695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.58|1.4|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||1.40|0.58|
91750525|NCT00977938|183393696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.15|1.64|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|||1.64|0.15|
91750526|NCT00977938|183393697|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.03|||||TWO_SIDED|95.0|-0.21|2.28|||||30-month DAPT vs. 12-month DAPT|||2.28|-0.21|
91750527|NCT00747344|183393800|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. With 120 subjects (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight (\<=65kg vs \> 65 kg). For all the scenarios evaluated, the power was \> 99% at a significance level of 0.05.||||<0.001
91750528|NCT00747344|183393801|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
91750529|NCT00747344|183393802|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
91750530|NCT02648022|183393826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91||||0.07|TWO_SIDED|95.0|0.92|9.27|||Regression, Linear|Multivariable Regression Analysis||||9.27|0.92|0.07
91750531|NCT02182440|183393835|SUPERIORITY||Difference in LS means|-16.53|STANDARD_ERROR_OF_MEAN|19.243||0.949|TWO_SIDED|95.0|-62.57|29.5|||ANOVA|||Analysis for Part 1||29.50|-62.57|0.949
91750532|NCT02182440|183393835|SUPERIORITY||Difference in LS means|-4.65|STANDARD_ERROR_OF_MEAN|9.305||0.691|TWO_SIDED|95.0|-23.09|13.8|||ANOVA|||Analysis for Part 2||13.80|-23.09|0.691
91750533|NCT02182440|183393835|SUPERIORITY||Combined p-value|0.896||||0.896|TWO_SIDED||||||Inverse normal method||The p-values from Part 1 (see Statistical Analysis 1) and Part 2 (see Statistical Analysis 2) were combined to an overall p-value using the inverse normal method.|Combination of analysis results from Part 1 (see statistical Analysis 1) and Part 2 (see Statistical analysis 2)||||0.896
91750534|NCT02182440|183393836|SUPERIORITY||Odds Ratio (OR)|1.4||||0.28|TWO_SIDED|95.0|0.8|2.4|||Chi-squared|||||2.4|0.8|0.28
91750535|NCT02182440|183393837|SUPERIORITY||Mean Difference (Net)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.02|0.02
91750536|NCT02182440|183393838|SUPERIORITY||Mean Difference (Net)|0.12||||0.03|TWO_SIDED|95.0|0.01|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.01|0.03
91750537|NCT02182440|183393839|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.045|TWO_SIDED|95.0|1.0|3.1|||Regression, Logistic|||||3.1|1.0|0.045
91750538|NCT02182440|183393840|SUPERIORITY||Hazard Ratio (HR)|1.85||||0.03|TWO_SIDED|95.0|1.06|3.26|||Regression, Logistic|||||3.26|1.06|0.03
91750539|NCT00072293|183393841|NON_INFERIORITY_OR_EQUIVALENCE|As originally designed, target accrual was 1960 patients with analysis planned after 558 events. These targets were based on having 90% power to detect non-inferiority of no axillary dissection with a one-sided statistical signifi cance level of 10% (ie, α=0·10) under the assumption that 5-year disease-free survival with axillary dissection was 70% and defining non-inferiority as a hazard ratio (HR) of less than 1·25 (no axillary dissection relative to axillary dissection).|Hazard Ratio (HR)|0.78||||0.004|TWO_SIDED|95.0|0.55|1.11||Test for non-inferiority of no axillary dissection. Stratified logrank test compared groups. HR (no-AD vs AD) estimated from test statistic and variance as HR=exp(\[O-E\]/V), compared to 1.25 in 1-sided test of non-inferiority.|1-sided non-inferiority test||Hazard Ratio is no axillary dissection/axillary dissection.|||1.11|0.55|0.004
91750540|NCT00072293|183393842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.73|TWO_SIDED|90.0|0.52|1.54|||Log Rank||Hazard Ratio is no axillary dissection/axillary dissection.|||1.54|0.52|0.73
91750541|NCT01605227|183393866|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.213|TWO_SIDED|95.0|0.76|1.06|||Log Rank|The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||1.06|0.76|0.213
91750542|NCT01605227|183393867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||||<0.001
91750543|NCT01605227|183393868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.57|||Log Rank|The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.||||0.57|0.40|<0.001
91750544|NCT02847858|183393934|SUPERIORITY||Slope|1.16||||0.011|TWO_SIDED|95.0|0.26|2.07||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up||2.07|0.26|0.011
91750545|NCT02847858|183393934|SUPERIORITY||Slope|1.64|||<|0.001|TWO_SIDED|95.0|1.01|2.07||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||2.07|1.01|<0.001
91750546|NCT02847858|183393934|SUPERIORITY||Slope|0.48||||0.108|TWO_SIDED|95.0|-0.1|1.05||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||1.05|-0.10|0.108
91750547|NCT02847858|183393935|SUPERIORITY||F statistic:Time X Arm Interaction|3.23||||0.04|TWO_SIDED|||||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months||||0.04
91750548|NCT02847858|183393935|SUPERIORITY||Slope|0.82||||0.218|TWO_SIDED|95.0|-0.48|2.11||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site||Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months|Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline|2.11|-0.48|.218
91505939|NCT00851799|182882096|SUPERIORITY_OR_OTHER||Difference in Change|0.24||||0.53|TWO_SIDED|97.5|-0.63|1.11||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.11|-0.63|0.53
91505940|NCT00851799|182882096|SUPERIORITY_OR_OTHER||Difference in Change (%)|-0.21||||0.53|TWO_SIDED|97.5|-0.98|0.55||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||0.55|-0.98|0.53
91505941|NCT04365556|182882134|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance is p\<.05|ANCOVA|||||||<0.001
91505942|NCT04365556|182882135|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||0.69
91505943|NCT04920123|182882152|SUPERIORITY|||||||0.997||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.997
91505944|NCT04920123|182882153|SUPERIORITY|||||||0.5||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.500
91505945|NCT04920123|182882154|SUPERIORITY|||||||0.821||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.821
91505946|NCT04920123|182882155|SUPERIORITY|||||||0.995||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.995
91750549|NCT02847858|183393935|SUPERIORITY||Slope|1.58||||0.008|TWO_SIDED|95.0|0.38|2.77||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months||2.77|0.38|0.008
91505947|NCT04920123|182882156|NON_INFERIORITY|Higher scores indicate more severe depression.||||||0.076|||||||t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.076
91505948|NCT04920123|182882157|SUPERIORITY|||||||0.432|||||||t-test, 1 sided|The threshold for statistical significance was p=0.05||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.432
91505949|NCT04920123|182882158|SUPERIORITY|Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||||0.75|||||||t-test, 1 sided|||||||0.750
91505950|NCT03249779|182882184|SUPERIORITY|||||||0.0396|||||||t-test, 2 sided|||||||0.0396
91505951|NCT03249779|182882185|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.1330
91505952|NCT01604343|182882197|SUPERIORITY_OR_OTHER||Percentage Difference|28.4|||<|0.001|TWO_SIDED|95.0|22.8|33.8|||Cochran-Mantel-Haenszel|||||33.8|22.8|< 0.001
91505953|NCT01604343|182882197|SUPERIORITY_OR_OTHER||Percentage Difference|27.1|||<|0.001|TWO_SIDED|95.0|21.6|32.6|||Cochran-Mantel-Haenszel|||||32.6|21.6|< 0.001
91505954|NCT01604343|182882198|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
91505955|NCT01604343|182882198|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
91750550|NCT02847858|183393936|SUPERIORITY||F statistic:Time X Arm Interaction|3.72||||0.025|TWO_SIDED|||||Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months||||0.025
91505956|NCT01604343|182882199|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.226|||<|0.001|TWO_SIDED|95.0|-0.29|-0.17|||ANCOVA|||||-0.17|-0.29|<0.001
91505957|NCT01604343|182882199|SUPERIORITY_OR_OTHER||LS mean difference|-0.256|||<|0.001|TWO_SIDED|95.0|-0.32|-0.2|||ANCOVA|||||-0.20|-0.32|<0.001
91505958|NCT01604343|182882200|SUPERIORITY_OR_OTHER||Percentage Difference|17.8|||<|0.001|TWO_SIDED|95.0|13.1|22.4|||Cochran-Mantel-Haenszel|||||22.4|13.1|< 0.001
91505959|NCT01604343|182882200|SUPERIORITY_OR_OTHER||Percentage Difference|20.8|||<|0.001|TWO_SIDED|95.0|16.1|25.6|||Cochran-Mantel-Haenszel|||||25.6|16.1|< 0.001
91505960|NCT01604343|182882201|SUPERIORITY_OR_OTHER||Percentage Difference|20.5|||<|0.001|TWO_SIDED|95.0|16.4|24.6|||Cochran-Mantel-Haenszel|||||24.6|16.4|< 0.001
91505961|NCT01604343|182882201|SUPERIORITY_OR_OTHER||Percentage Difference|19.9|||<|0.001|TWO_SIDED|95.0|15.8|24.0|||Cochran-Mantel-Haenszel|||||24.0|15.8|< 0.001
91505962|NCT01604343|182882202|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.001|TWO_SIDED|95.0|1.4|5.8|||Cochran-Mantel-Haenszel|||||5.8|1.4|0.001
91505963|NCT01604343|182882202|SUPERIORITY_OR_OTHER||Percentage Difference|7.2|||<|0.001|TWO_SIDED|95.0|4.6|9.8|||Cochran-Mantel-Haenszel|||||9.8|4.6|< 0.001
91505964|NCT00436748|182882231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Exact|||The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||<0.001
91750551|NCT02847858|183393936|SUPERIORITY||Odds Ratio (OR)|3.29||||0.042|TWO_SIDED|95.0|1.04|10.36||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months||10.36|1.04|0.042
91750552|NCT02847858|183393936|SUPERIORITY||Odds Ratio (OR)|5.54||||0.005|TWO_SIDED|95.0|1.7|18.06||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months||18.06|1.7|0.005
91750553|NCT02847858|183393937|SUPERIORITY||Slope|1.62|||<|0.001|TWO_SIDED|95.0|1.43|1.82||Time main effect; a priori threshold for statistical significance p \<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is post-app minus pre-app|Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants||1.82|1.43|<0.001
91750554|NCT02847858|183393938|SUPERIORITY||Odds Ratio (OR)|2.22||||0.055|TWO_SIDED|95.0|0.98|5.01||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit||5.01|0.98|0.055
91750555|NCT02847858|183393939|SUPERIORITY||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.78||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method||3.78|0.73|0.227
91750556|NCT02210221|183394019|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in 6-month mortality||||<0.0001
91750557|NCT02210221|183394019|OTHER||observed to expected ratio|0.7|||||TWO_SIDED|95.0|0.62|0.76|||||numerator: 6-month mortality observed denominator: 6-month mortality expected 95% CIs estimated according to a Poisson distribution|||0.76|0.62|
91750558|NCT02210221|183394020|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 mental component summary||||<0.0001
91750559|NCT02210221|183394020|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 physical component summary||||<0.0001
91750560|NCT02210221|183394021|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in Qolibri Overall Scale||||<0.0001
91505965|NCT00436748|182882231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|||||||Exact|||The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||0.293
91750561|NCT02210221|183394022|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750562|NCT02210221|183394023|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750563|NCT02210221|183394024|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750564|NCT02210221|183394025|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750565|NCT02210221|183394026|NON_INFERIORITY|non-inferiority margin = 0||||||0.169|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.169
91750566|NCT02210221|183394027|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||Fisher Exact|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750567|NCT02210221|183394028|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750568|NCT02210221|183394029|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750569|NCT02210221|183394030|NON_INFERIORITY|non-inferiority margin = 0||||||0.637|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.637
91750570|NCT02210221|183394031|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750571|NCT02210221|183394032|NON_INFERIORITY|non-inferiority margin = 0||||||0.48|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.480
91750572|NCT02210221|183394033|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750573|NCT02210221|183394034|NON_INFERIORITY|non-inferiority margin = 0||||||0.024|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.024
91750574|NCT02210221|183394035|NON_INFERIORITY|non-inferiority margin = 0||||||0.064|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.064
91750575|NCT02210221|183394036|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
91750576|NCT02230761|183394037|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.020
91750577|NCT02230761|183394038|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91750578|NCT02230761|183394039|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
91750579|NCT00405964|183394054|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Determined for site. P-value of \<.001 for treatment as well.|ANOVA|||||||<.001
91750580|NCT00405964|183394055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0||||Determined for site. Treatment p-value \<.001|ANOVA|||||||0.035
91750581|NCT00405964|183394056|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Same p-value for treatment and site.|ANOVA|||||||<.001
91750582|NCT01344538|183394122|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91750583|NCT00929773|183394153|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91505966|NCT03754959|182882313|OTHER||Ratio|97.9|||||TWO_SIDED|90.0|90.2|106.2|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.2|90.2|
91750584|NCT00929773|183394154|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
91750585|NCT00929773|183394155|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91750586|NCT00929773|183394156|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91750587|NCT00929773|183394157|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91750588|NCT00929773|183394158|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91750589|NCT00328653|183394160|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H Chi-square|1.2187||||0.2699|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2699
91750590|NCT00328653|183394160|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H Chi-square|1.2359||||0.2719|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2719
91750591|NCT00328653|183394163|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H-Chi-square|4.2925||||0.0386|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0386
91750592|NCT00328653|183394163|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H-Chi-square|5.3007||||0.0208|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0208
91750593|NCT03541187|183394193|SUPERIORITY|The comparison between arms will be conducted using an analysis of covariance (ANCOVA) model, in which the change from the baseline to the 12-month TNSS mean serves as the outcome. The ANCOVA model will incorporate factors for treatment while adjusting for both the baseline TNSS mean and site.|Least Square Mean Difference|-0.23||||0.63|TWO_SIDED|95.0|-1.15|0.7|||ANCOVA|||||0.70|-1.15|0.63
91750594|NCT03541187|183394195|SUPERIORITY||Least Square Means Difference|-0.17||||0.69|TWO_SIDED|95.0|-0.99|0.66|||ANCOVA|||||0.66|-0.99|0.69
91750595|NCT03541187|183394196|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.51|TWO_SIDED|95.0|0.42|1.54|||Regression, Cox||At the reactive dose of 15.4 mcg/mL after 12 months, there were 11 participants who were right-censored in the Cockroach SCIT arm and 8 participants who were right-censored in the Placebo arm.|||1.54|0.42|.51
91750596|NCT03541187|183394197|SUPERIORITY||Least Square Means Difference|-0.03||||0.91|TWO_SIDED|95.0|-0.54|0.49|||ANCOVA|||||0.49|-0.54|0.91
91750597|NCT03541187|183394198|SUPERIORITY||Least Square Means Difference|5.32|||<|0.001|TWO_SIDED|95.0|4.77|5.87|||ANCOVA|||||5.87|4.77|<0.001
91750598|NCT03199053|183394226|SUPERIORITY||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.274|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||||-0.49|-1.57|< 0.001
91750599|NCT03199053|183394227|SUPERIORITY||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.251||0.078|TWO_SIDED|95.0|-0.93|0.05|||ANCOVA|||||0.05|-0.93|0.078
91750600|NCT03199053|183394228|SUPERIORITY||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.44|-0.27|||ANCOVA|||||-0.27|-1.44|0.004
91750601|NCT03199053|183394229|SUPERIORITY||Adjusted mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.277||0.067|TWO_SIDED|95.0|-1.05|0.04|||ANCOVA|||||0.04|-1.05|0.067
91750602|NCT03199053|183394230|SUPERIORITY||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.76|-0.62|||ANCOVA|||||-0.62|-1.76|< 0.001
91750603|NCT03199053|183394231|SUPERIORITY||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.146|TWO_SIDED|95.0|-0.92|0.14|||ANCOVA|||||0.14|-0.92|0.146
91750604|NCT03199053|183394232|SUPERIORITY||Adjusted mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.479||0.024|TWO_SIDED|95.0|-2.02|-0.14|||ANCOVA|||||-0.14|-2.02|0.024
91750605|NCT03199053|183394233|SUPERIORITY||Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.528||0.833|TWO_SIDED|95.0|-1.15|0.92|||ANCOVA|||||0.92|-1.15|0.833
91750606|NCT03199053|183394234|SUPERIORITY||Adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.525||0.047|TWO_SIDED|95.0|-2.07|-0.01|||ANCOVA|||||-0.01|-2.07|0.047
91750607|NCT03199053|183394235|SUPERIORITY||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.49||0.268|TWO_SIDED|95.0|-1.5|0.42|||ANCOVA|||||0.42|-1.50|0.268
91750608|NCT03199053|183394236|SUPERIORITY||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.505||0.026|TWO_SIDED|95.0|-2.11|-0.13|||ANCOVA|||||-0.13|-2.11|0.026
91750609|NCT03199053|183394237|SUPERIORITY||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.618||0.644|TWO_SIDED|95.0|-0.92|1.5|||ANCOVA|||||1.50|-0.92|0.644
91750610|NCT03199053|183394238|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.019|TWO_SIDED|95.0|1.2|11.7|||Regression, Logistic|||||11.7|1.2|0.019
91750611|NCT03199053|183394238|SUPERIORITY||Adjusted Odds Ratio|2.6||||0.114|TWO_SIDED|95.0|0.8|8.6|||Regression, Logistic|||||8.6|0.8|0.114
91750612|NCT03199053|183394239|SUPERIORITY||Adjusted Odds Ratio|3.5||||0.042|TWO_SIDED|95.0|1.0|11.4|||Weighted Logistic Regression|||||11.4|1.0|0.042
91750613|NCT03199053|183394239|SUPERIORITY||Adjusted Odds Ratio|2.3||||0.175|TWO_SIDED|95.0|0.7|7.4|||Weighted Logistic Regression|||||7.4|0.7|0.175
91750614|NCT03199053|183394240|SUPERIORITY||Adjusted Odds Ratio|4.4||||0.009|TWO_SIDED|95.0|1.4|13.2|||Weighted Logistic Regression|||||13.2|1.4|0.009
91750615|NCT03199053|183394240|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.042|TWO_SIDED|95.0|1.1|13.5|||Weighted Logistic Regression|||||13.5|1.1|0.042
91750616|NCT03199053|183394241|SUPERIORITY||Adjusted mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.496||0.955|TWO_SIDED|95.0|-1.0|0.94|||ANCOVA|||||0.94|-1.00|0.955
91505967|NCT03754959|182882313|OTHER||Ratio|95.9|||||TWO_SIDED|90.0|89.9|102.4|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|||102.4|89.9|
91750617|NCT03199053|183394241|SUPERIORITY||Adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.495||0.64|TWO_SIDED|95.0|-1.2|0.74|||ANCOVA|||||0.74|-1.20|0.640
91750618|NCT03199053|183394242|SUPERIORITY||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.896||0.476|TWO_SIDED|95.0|-2.39|1.12|||ANCOVA|||||1.12|-2.39|0.476
91750619|NCT03199053|183394242|SUPERIORITY||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|1.017||0.075|TWO_SIDED|95.0|-3.81|0.18|||ANCOVA|||||0.18|-3.81|0.075
91750620|NCT03199053|183394243|SUPERIORITY||Unadjusted Difference in Percentage|-19.7||||0.182|TWO_SIDED|95.0|-44.5|5.7|||Fisher Exact|||||5.7|-44.5|0.182
91750621|NCT03199053|183394244|SUPERIORITY||Unadjusted Difference in Percentage|-6.3||||0.65|TWO_SIDED|95.0|-29.8|16.5|||Fisher Exact|||||16.5|-29.8|0.650
91750622|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5||||||Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.5|-1.6|
91750623|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
91750624|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.3|||||TWO_SIDED|95.0|-4.7|1.9||||||Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.9|-4.7|
91750625|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
91750626|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
91750627|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.2|||||TWO_SIDED|95.0|-3.6|0.8||||||Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||0.8|-3.6|
91750628|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
91750629|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
91750630|NCT01323270|183394251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
91750631|NCT01057225|183394261|SUPERIORITY_OR_OTHER||Dose Level|1.0|||||TWO_SIDED||||||||Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.|||||
91750632|NCT00246025|183394280|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155||95.0|-30.2|-3.4||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-3.4|-30.2|0.0155
91750633|NCT00246025|183394280|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006||95.0|-37.0|-10.5||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-10.5|-37.0|0.0006
91750634|NCT00246025|183394280|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001||95.0|-45.4|-19.6||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-19.6|-45.4|<0.0001
91750635|NCT00246025|183394281|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.0|-9.1|0.1124
91750636|NCT00246025|183394281|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.1|-9.1|0.1183
91750637|NCT00246025|183394281|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-1.3|-10.3|0.0138
91750638|NCT00246025|183394282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.0|-9.1|0.1124
91750639|NCT00246025|183394282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.1|-9.1|0.1183
91750640|NCT00246025|183394282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-1.3|-10.3|0.0138
91750641|NCT00246025|183394283|SUPERIORITY_OR_OTHER|||||||0.6107||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6107
91750642|NCT00246025|183394283|SUPERIORITY_OR_OTHER|||||||1||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||1.0000
91750643|NCT00246025|183394283|SUPERIORITY_OR_OTHER|||||||0.6162||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6162
91750644|NCT00246025|183394284|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155|TWO_SIDED|95.0|-30.2|-3.4||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-3.4|-30.2|0.0155
91750645|NCT00246025|183394284|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006|TWO_SIDED|95.0|-37.0|-10.5||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-10.5|-37.0|0.0006
91750646|NCT00246025|183394284|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001|TWO_SIDED|95.0|-45.4|-19.6||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-19.6|-45.4|<.0001
91750647|NCT00246025|183394287|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||1.0000
91532217|NCT02550873|182940934|SUPERIORITY|||||||0.1846||||||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.1846
91750648|NCT00246025|183394287|SUPERIORITY_OR_OTHER|||||||0.496||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.4960
91750649|NCT00246025|183394287|SUPERIORITY_OR_OTHER|||||||0.6223||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.6223
91750650|NCT00246025|183394287|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.5||||0.1513|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1513
91750651|NCT00246025|183394287|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.4||||0.1696|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1696
91750652|NCT00246025|183394287|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.7||||0.7802|TWO_SIDED|95.0|-3.9|5.2|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||5.2|-3.9|0.7802
91750653|NCT00246025|183394287|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.7||||0.6313|TWO_SIDED|95.0|-5.3|8.7|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||8.7|-5.3|0.6313
91750654|NCT00246025|183394287|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.3||||0.5377|TWO_SIDED|95.0|-4.9|9.4|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||9.4|-4.9|0.5377
91750655|NCT00246025|183394287|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.8||||0.4493|TWO_SIDED|95.0|-4.4|10.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||10.0|-4.4|0.4493
91750656|NCT02437305|183394302|SUPERIORITY_OR_OTHER|||||||0.048||||||P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||0.048
91750657|NCT02437305|183394303|SUPERIORITY_OR_OTHER||||||>|0.5||||||P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||>0.50
91750658|NCT01118520|183394304|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||0.78
91750659|NCT01118520|183394304|SUPERIORITY|||||||0.89|||||||Mixed Models Analysis|||||||0.89
91750660|NCT03220581|183394315|SUPERIORITY||F|9.026||||0.004|TWO_SIDED||||||ANCOVA|Baseline number of days of game play in the past week was included as a covariate.||||||.004
91750661|NCT03220581|183394316|SUPERIORITY||F|7.922||||0.007|TWO_SIDED||||||ANCOVA|Covariate = number of days of gaming in the past week at baseline, reported by the parent.||||||.007
91750662|NCT03220581|183394317|SUPERIORITY||F|3.73||||0.059|TWO_SIDED||||||ANCOVA|Controlled for number of symptoms of Internet gaming disorder at baseline - assessed through clinical interview with child||||||.059
91750663|NCT03220581|183394318|SUPERIORITY||F|2.91||||0.095|TWO_SIDED||||||ANCOVA|Controlled for baseline number of symptoms of Internet gaming disorder, assessed through clinical interview with the parent||||||.095
91750664|NCT01071200|183394322|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon two sample test|||Change at hCG day : Wilcoxon two sample test was used to calculate p-value.||||0.07
91750665|NCT01527513|183394333|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|Mean Difference (Final Values)|33.2001||||0.7|TWO_SIDED|95.0|-137.593|203.993|||95% CI lower bound vs non-inf margin|||||203.993|-137.593|0.700
91750666|NCT01527513|183394334|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|95% CI lower bound vs non-inf margin|33.2001|||<|0.7|TWO_SIDED|95.0|-137.593|203.993|||ANCOVA||The predefined non-inferiority margin was -121ms.|||203.993|-137.593|<0.700
91750667|NCT01920893|183394336|SUPERIORITY||Least Square (LS) mean difference|-1.55||||0.0009|TWO_SIDED|95.0|-2.43|-0.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg QW vs Placebo|Analysis was performed by a mixed model repeated measures (MMRM) model.||-0.67|-2.43|0.0009
91750668|NCT01396265|183394347|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.2|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|60.815|72.057|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.057|60.815|
91750669|NCT01396265|183394348|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.18|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|60.656|72.213|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.213|60.656|
91750670|NCT01396265|183394349|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|78.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|72.363|84.968|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||84.968|72.363|
91750671|NCT02446418|183394358|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.8||||0.033|TWO_SIDED|95.0|0.1|1.5|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.|1.5|0.1|0.033
91750672|NCT02446418|183394359|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.4||||0.224|TWO_SIDED|95.0|-0.3|1.1|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.|1.1|-0.3|0.224
91505968|NCT03754959|182882313|OTHER||Ratio|101.0|||||TWO_SIDED|90.0|96.3|106.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.1|96.3|
91505969|NCT03754959|182882313|OTHER||Ratio|93.7|||||TWO_SIDED|90.0|86.8|101.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||101.1|86.8|
91505970|NCT03754959|182882313|OTHER||Ratio|93.1|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
91505971|NCT03754959|182882313|OTHER||Ratio|90.0|||||TWO_SIDED|90.0|83.8|96.7|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||96.7|83.8|
91505972|NCT03754959|182882314|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|95.6|116.9|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||116.9|95.6|
91505973|NCT03754959|182882314|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|106.5|129.6|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||129.6|106.5|
91505974|NCT03754959|182882314|OTHER||Ratio|112.6|||||TWO_SIDED|90.0|102.9|123.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.1|102.9|
91505975|NCT03754959|182882314|OTHER||Ratio|110.3|||||TWO_SIDED|90.0|90.1|135.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||135.1|90.1|
91505976|NCT03754959|182882314|OTHER||Ratio|96.4|||||TWO_SIDED|90.0|84.5|110.1|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||110.1|84.5|
91505977|NCT03754959|182882314|OTHER||Ratio|89.3|||||TWO_SIDED|90.0|74.9|106.4|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.4|74.9|
91532218|NCT02550873|182940935|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.31||0.7424|TWO_SIDED|90.0|-2.6|1.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||1.7|-2.6|0.7424
91505978|NCT03754959|182882315|OTHER||Ratio|98.3|||||TWO_SIDED|90.0|84.2|114.8|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.8|84.2|
91750673|NCT02446418|183394360|SUPERIORITY||Adjusted Odds Ratio|1.11||||0.82|TWO_SIDED|95.0|0.47|2.62|||Regression, Logistic|||Week 12|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|2.62|0.47|0.820
91750674|NCT02446418|183394360|SUPERIORITY||Adjusted Odds Ratio|1.41||||0.566|TWO_SIDED|95.0|0.43|4.6|||Regression, Logistic|||Week 24|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|4.60|0.43|0.566
91505979|NCT03754959|182882315|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|87.9|109.3|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||109.3|87.9|
91505980|NCT03754959|182882315|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|102.6|134.6|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||134.6|102.6|
91505981|NCT03754959|182882315|OTHER||Ratio|94.5|||||TWO_SIDED|90.0|85.5|104.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||104.4|85.5|
91505982|NCT03754959|182882315|OTHER||Ratio|98.2|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
91505983|NCT03754959|182882315|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|84.3|114.0|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.0|84.3|
91505984|NCT03754959|182882316|OTHER||Ratio|95.5|||||TWO_SIDED|90.0|81.3|112.1|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||112.1|81.3|
91505985|NCT03754959|182882316|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|91.5|122.0|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||122.0|91.5|
91505986|NCT03754959|182882316|OTHER||Ratio|116.3|||||TWO_SIDED|90.0|90.9|148.7|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||148.7|90.9|
91532219|NCT02550873|182940945|SUPERIORITY||Mean Difference (Net)|114.6|STANDARD_DEVIATION|56.1||0.0416|TWO_SIDED|90.0|22.2|207.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||207.1|22.2|0.0416
91750675|NCT03093974|183394363|SUPERIORITY|The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, pooled site (country) and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-time on treatment as an offset.|LS Mean rate ratio|0.612||||0.00101|TWO_SIDED|95.0|0.457|0.82|||two-sided Wald chi-square test|||||0.820|0.457|0.00101
91750676|NCT02863523|183394388|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91750677|NCT02863523|183394389|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
91750678|NCT02863523|183394390|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91505987|NCT03754959|182882316|OTHER||Ratio|106.8|||||TWO_SIDED|90.0|92.4|123.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.4|92.4|
91750679|NCT00882908|183394397|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|13.0||||0.051|TWO_SIDED|97.5|-1.9|28.0|||Regression, Logistic||Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.||28.0|-1.9|0.051
91750680|NCT00882908|183394397|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|18.9||||0.004|TWO_SIDED|97.5|4.4|33.5|||Regression, Logistic||Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.||33.5|4.4|0.004
91750681|NCT02084238|183394455|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparing the data between baseline and week 10.||||<0.01
91750682|NCT02818036|183394464|OTHER|difference in neural activity to social task when taking naltrexone as compared to placebo|||||<|0.01||||||a priori threshold for significance was p\<.05|t-test, 1 sided|degrees of freedom = 75||||||<.01
91505988|NCT03754959|182882316|OTHER||Ratio|83.9|||||TWO_SIDED|90.0|71.2|98.9|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||98.9|71.2|
91532220|NCT04320615|182940952|OTHER||Median Difference (Final Values)|-1.0||||0.36|TWO_SIDED|95.0|-2.5|0.0|||Van Elteren Test|||||0.0|-2.5|0.3600
91532221|NCT04320615|182940953|OTHER||Hazard Ratio (HR)|1.448||||0.0443|TWO_SIDED|95.0|1.01|2.08|||Log Rank|||||2.08|1.01|0.0443
91532222|NCT04320615|182940954|OTHER||Hazard Ratio (HR)|1.263||||0.082|TWO_SIDED|95.0|0.97|1.64|||Log Rank|||||1.64|0.97|0.0820
91532223|NCT04320615|182940955|OTHER||Hazard Ratio (HR)|1.35||||0.037|TWO_SIDED|95.0|1.02|1.79|||Log Rank|||||1.79|1.02|0.0370
91532224|NCT04320615|182940956|OTHER||Weighted % difference|-6.2||||0.0996|TWO_SIDED|95.0|-13.8|1.4|||Cochran-Mantel-Haenszel|||||1.4|-13.8|0.0996
91750683|NCT02818036|183394465|OTHER|differences in feelings of social connection between those who took naltrexone and those who took placebo||||||0.338||||||a priori threshold for statistical significance was p\<.05|t-test, 2 sided|||||||.338
91750684|NCT01038713|183394466|SUPERIORITY_OR_OTHER|||||||0.22||||||Analysis comparing the number of patients who had stent occlusion|Chi-squared|3 x 2 contingency table comparing all three groups||||||0.22
91750685|NCT01038713|183394466|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of attempted surgical resection||||0.14
91750686|NCT01038713|183394466|SUPERIORITY_OR_OTHER|||||||0.96|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of death between groups||||0.96
91750687|NCT01038713|183394467|SUPERIORITY_OR_OTHER|||||||1|||||||ANOVA|||||||1.00
91750688|NCT03777917|183394475|SUPERIORITY||Difference in Response Rates|72.1|||<|0.0001|TWO_SIDED|95.0|47.5|83.5|||Fisher Exact|The Fisher's exact test was used to test for the superiority of treatment (Belotero Balance®) over control.|Two-sided Newcombe confidence interval (CI) for the difference in response rates.|||83.5|47.5|< 0.0001
91505989|NCT03754959|182882316|OTHER||Ratio|87.2|||||TWO_SIDED|90.0|73.5|103.5|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||103.5|73.5|
91505990|NCT00449956|182882325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||95.0|-1.3|-0.06|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||-0.06|-1.30|
91505991|NCT00449956|182882325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 1.2 mmHg|Mean Difference (Final Values)|0.28||||||95.0|-0.22|0.78|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||0.78|-0.22|
91505992|NCT03167879|182882328|SUPERIORITY||Odds Ratio (OR)|10.63|||||TWO_SIDED|95.0|2.79|40.49||||||||40.49|2.79|
91505993|NCT03167879|182882329|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.25|2.09||||||||2.09|0.25|
91505994|NCT03167879|182882330|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.02|257.6||||||||257.6|0.02|
91532225|NCT04320615|182940956|OTHER||Weighted % difference|-8.9||||0.1355|TWO_SIDED|95.0|-20.7|3.0|||Cochran-Mantel-Haenszel|||||3.0|-20.7|0.1355
91532226|NCT04320615|182940957|OTHER||Median Difference (Final Values)|5.5||||0.3202|TWO_SIDED|95.0|-2.8|13.0|||Van Elteren test|||||13.0|-2.8|0.3202
91532227|NCT04320615|182940958|OTHER||Weighted % difference|-5.7||||0.1514|TWO_SIDED|95.0|-13.7|2.2|||Cochran-Mantel-Haenszel|||||2.2|-13.7|0.1514
91532228|NCT04320615|182940958|OTHER||Weighted % difference|-14.8||||0.029|TWO_SIDED|95.0|-28.6|-1.0|||Cochran-Mantel-Haenszel|||||-1.0|-28.6|0.0290
91532229|NCT04320615|182940959|OTHER||Median Difference (Final Values)|-5.8||||0.0454|TWO_SIDED|95.0|-15.0|2.9|||Van Elteren test|||||2.9|-15.0|0.0454
91532230|NCT04320615|182940960|OTHER||Median Difference (Final Values)|-1.0||||0.0548|TWO_SIDED|95.0|-2.0|0.5|||Van Elteren test|||||0.5|-2.0|0.0548
91532231|NCT04320615|182940961|OTHER||Hazard Ratio (HR)|0.79||||0.1627|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1627
91505995|NCT01067768|182882334|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.5|1.3|||||The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.|The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.||1.3|0.50|
91505996|NCT01067768|182882335|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients||||0.016
91505997|NCT02972632|182882337|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
91750689|NCT00320372|183394481|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|38.1|||||TWO_SIDED|95.0|36.3|39.9|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||39.9|36.3|
91532232|NCT04320615|182940962|OTHER||Weighted % difference|0.3||||0.941|TWO_SIDED|95.0|-7.6|8.2|||Cochran-Mantel-Haenszel|||||8.2|-7.6|0.9410
91750690|NCT00320372|183394481|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|17.0|||||TWO_SIDED|95.0|15.2|19.0|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||19.0|15.2|
91750691|NCT00320372|183394481|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
91505998|NCT02972632|182882337|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
91532233|NCT04320615|182940963|OTHER||Hazard Ratio (HR)|1.307||||0.0528|TWO_SIDED|95.0|1.0|1.72|||Log Rank|||||1.72|1.00|0.0528
91532234|NCT04320615|182940964|OTHER||Median Difference (Final Values)|-1.5||||0.0477|TWO_SIDED|95.0|-9.0|0.5|||Van Elteren test|||||0.5|-9.0|0.0477
91532235|NCT02107443|182940977|SUPERIORITY||Mean Difference (Final Values)|3.59|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
91750692|NCT00320372|183394482|SUPERIORITY_OR_OTHER|||||||0.1015|TWO_SIDED|||||Comparison for Kaplan Meier Median Time until recurrence|Log Rank|Null hypothesis: median TUR between 2 groups is not different. Alternate hypothesis: median TUR between 2 groups is different.||||||0.1015
91532236|NCT02107443|182940978|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.041|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.041
91750693|NCT00320372|183394483|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|19.8|||||TWO_SIDED|95.0|18.4|21.3|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||21.3|18.4|
91750694|NCT00320372|183394483|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|8.1|||||TWO_SIDED|95.0|6.9|9.5|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||9.5|6.9|
91750695|NCT00320372|183394483|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
91750696|NCT00320372|183394489|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.34997|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<0.0001
91750697|NCT00320372|183394490|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||3 Month Time point||||<.0001
91750698|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||6 Month Time point||||.0068
91750699|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||9 Month Time point||||.0008
91750700|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||12 Month Time point||||.0003
91750701|NCT00320372|183394490|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||18 Month Time point||||<.0001
91750702|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||24 Month Time point||||.0059
91750703|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0028|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||30 Month Time point||||.0028
91750704|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||36 Month Time point||||.0002
91750705|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0051|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||42 Month Time point||||.0051
91505999|NCT02972632|182882338|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
91506000|NCT02972632|182882338|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
91506001|NCT02972632|182882339|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
91750706|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0363|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||48 Month Time point||||.0363
91750707|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||54 Month Time point||||.0048
91750708|NCT00320372|183394490|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||60 Month Time point||||.0009
91506002|NCT02972632|182882339|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
91532237|NCT02107443|182940980|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.03|TWO_SIDED|95.0|0.12|1.98|||Mixed Models Analysis|The above p-values is for 4-6 weeks.|The above values are for 4-6 weeks.|||1.98|0.12|0.03
91506003|NCT02972632|182882340|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
91506004|NCT02972632|182882341|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
91506005|NCT02972632|182882342|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
91506006|NCT03450707|182882371|OTHER||Mean Difference (Final Values)|0.34||||0.72|TWO_SIDED|95.0|-1.82|2.5||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 24 hours.~Lactate imputed using a penalty (20pc increase) for patients who expired."|Mixed Models Analysis|P-value is for the comparison at 24 hours from the mixed model (i.e, not a global p-value)||||2.50|-1.82|0.72
91506007|NCT03450707|182882372|OTHER||Mean Difference (Final Values)|-0.38||||0.43|TWO_SIDED|95.0|-1.34|0.58|||Regression, Linear|||As AUC-VO2s turned out to be normally distributed, we used a linear regression model to compare mean AUC-VO2s between treatment groups controlling for average temperature.||0.58|-1.34|0.43
91506008|NCT03450707|182882373|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test, testing the null hypothesis that there is no difference in the distribution of 72-hour lactates between thiamine and placebo groups.|No parameter estimated other than p-value = 0.88 from Wilcoxon rank-sum test.|||0.88
91506009|NCT03450707|182882374|OTHER||Mean Difference (Final Values)|0.4||||0.072|TWO_SIDED|95.0|0.01|0.8||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||0.80|0.01|0.072
91506010|NCT03450707|182882375|OTHER||Mean Difference (Final Values)|2.4||||0.044|TWO_SIDED|95.0|0.1|4.7||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||4.7|0.1|0.044
91750709|NCT00320372|183394490|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|12.1009|||||TWO_SIDED|95.0|10.8979|13.3039|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||13.3039|10.8979|
91750710|NCT00320372|183394490|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|7.5964|||||TWO_SIDED|95.0|6.1327|9.0602|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||9.0602|6.1327|
91750711|NCT00320372|183394490|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||||<.0001
91750712|NCT00320372|183394491|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14837|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
91750713|NCT00320372|183394492|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14819|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture.~Alternate hypothesis: There is no correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
91750714|NCT00320372|183394493|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.04625||||0.0012|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||.0012
91750715|NCT04063787|183394494|EQUIVALENCE|The null hypothesis is the difference is zero. Thus the equivalence margin equals zero.|Mean Difference (Final Values)|0.408|STANDARD_DEVIATION|1.05||0.012|TWO_SIDED||||||t-test, 2 sided|Paired t-test||Compare before and after use of Fist Assist||||0.012
91532238|NCT02107443|182940980|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.08|TWO_SIDED|95.0|-0.11|1.77|||Mixed Models Analysis|The above p-value is for is for 3 months.|The above values are for 3 months|||1.77|-0.11|.08
91750716|NCT04883528|183394541|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
91750717|NCT04883528|183394542|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||||||0.88
91750718|NCT04883528|183394543|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
91750719|NCT04883528|183394544|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.85
91506011|NCT03450707|182882376|OTHER||Mean Difference (Final Values)|-48.5||||0.828|TWO_SIDED|95.0|-297.0|200.0||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH quantity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||200.0|-297.0|0.828
91506012|NCT03450707|182882379|OTHER||Mean Difference (Final Values)|2.34||||0.1|TWO_SIDED|95.0|0.47|4.22||Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||4.22|0.47|0.10
91506013|NCT03450707|182882381|OTHER||Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-3.6|1.6||Mixed model controlling for repeated measures within patients used to get a mean difference in Basal Respiration between the thiamine and placebo groups at 24 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.|Mean difference uses a non-logged version of the variable.|||1.6|-3.6|0.43
91506014|NCT03450707|182882382|OTHER||Mean Difference (Final Values)|0.76||||0.02|TWO_SIDED|95.0|-0.27|1.78||Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||1.78|-0.27|0.02
91506015|NCT01988571|182882387|SUPERIORITY|Power described in protocol.|Mean Difference (Net)|0.1608|STANDARD_ERROR_OF_MEAN|0.7787||0.84|TWO_SIDED||||||ANCOVA|Adjusted for multiple imputation of missing data||Linear models adjusting for baseline values and utilized multiple imputation for missing data.||||0.84
91506016|NCT00004412|182882397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.05|TWO_SIDED||||||Fisher Exact|||Percentage of ulcers undergoing partial and complete healing compared at 12 weeks. Mean Ulcer areas were calculated utilizing computerized planimetry, ulcer area tracings, and photography for baseline and 12 weeks and compared between the two study Arms.||||0.05
91506017|NCT05876273|182882413|OTHER|The statistical analysis included general linear models (GLM), with repeated measures (NAP vs UMPC) and a covariate the 1-hour average CGM level prior to initiating either controller. This covariate was used to compute the adjusted performance differences between NAP and UMPC. The data was analyzed using the GLM procedures of IBM SPSS 28.0.||||||0.2||||||1-hour average CGM level prior to initiating either controller was included as a covariate in the analysis. This covariate was used to compute the adjusted performance differences between NAP and UMPC.|GLM with Repeated Measures|General linear models (GLM), with repeated measures (NAP vs UMPC)||||||0.2
91506018|NCT03917420|182882438|OTHER|Correlation|Spearman's Rho|-0.455|||||TWO_SIDED|||||||||||||
91506019|NCT03917420|182882439|OTHER|Correlation|Spearman's Rho|0.152|||||TWO_SIDED|||||||||||||
91506020|NCT03917420|182882440|OTHER|Correlation|Spearman's Rho|0.564|||||TWO_SIDED|||||||||||||
91506021|NCT03917420|182882441|OTHER|Correlation|Spearman's Rho|0.285|||||TWO_SIDED|||||||||||||
91506022|NCT00591942|182882449|NON_INFERIORITY|95% CI were used|KM Survival Curves|0.5637||||0.5637|TWO_SIDED||||||Chi-squared|df=1||||||0.5637
91506023|NCT03373383|182882461|SUPERIORITY||Percent reduction|17.2|||=|0.102|TWO_SIDED|95.0|-3.8|33.9||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||33.9|-3.8|=0.102
91506024|NCT03373383|182882461|SUPERIORITY||Percent reduction|19.1|||=|0.064|TWO_SIDED|95.0|-1.2|35.4||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.4|-1.2|=0.064
91506025|NCT03373383|182882461|SUPERIORITY||Percent reduction|19.2|||=|0.063|TWO_SIDED|95.0|-1.2|35.5||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.5|-1.2|=0.063
91506026|NCT03373383|182882461|SUPERIORITY||Percent reduction|12.4|||=|0.248|TWO_SIDED|95.0|-9.7|30.1||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp\[diff\]), where diff was the model estimate of the log ratio between each PSL group and placebo group.||30.1|-9.7|=0.248
91506027|NCT03373383|182882462|SUPERIORITY||Odds Ratio (OR)|2.72|||=|0.081|TWO_SIDED|95.0|0.88|8.39||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||8.39|0.88|=0.081
91506028|NCT03373383|182882462|SUPERIORITY||Odds Ratio (OR)|2.37|||=|0.137|TWO_SIDED|95.0|0.76|7.41||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||7.41|0.76|=0.137
91532239|NCT02107443|182940980|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.2|TWO_SIDED|95.0|-0.36|1.59|||Mixed Models Analysis|The above p-value is for 6 months|The above values are for 6 months.|||1.59|-0.36|0.20
91506029|NCT03373383|182882462|SUPERIORITY||Odds Ratio (OR)|2.16|||=|0.192|TWO_SIDED|95.0|0.68|6.89||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||6.89|0.68|=0.192
91506030|NCT03373383|182882462|SUPERIORITY||Odds Ratio (OR)|3.14|||=|0.041|TWO_SIDED|95.0|1.05|9.42||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||9.42|1.05|=0.041
91532240|NCT02325713|182941065|SUPERIORITY_OR_OTHER||Geometric Least square (LS) mean ratio|96.2|||||TWO_SIDED|90.0|83.7|110.6||||||||110.6|83.7|
91750720|NCT04883528|183394545|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||||||0.80
91750721|NCT04883528|183394546|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91506031|NCT03373383|182882466|SUPERIORITY||Odds Ratio (OR)|2.09|||=|0.045|TWO_SIDED|95.0|1.02|4.3||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||4.30|1.02|=0.045
91750722|NCT04883528|183394547|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
91750723|NCT04883528|183394548|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|||||||0.95
91750724|NCT04883528|183394549|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91750725|NCT04883528|183394553|SUPERIORITY||Least squares mean difference|-0.01||||0.64|TWO_SIDED|95.0|-0.07|0.04|||Mixed Models Analysis|||||0.04|-0.07|0.64
91750726|NCT04883528|183394554|SUPERIORITY||Least squares mean difference|-7.55||||0.04|TWO_SIDED|95.0|-14.59|0.52|||Mixed Models Analysis|||||0.52|-14.59|0.04
91750727|NCT04948307|183394557|SUPERIORITY|||||||0.7326|||||||Chi-squared|||||||0.7326
91750728|NCT04948307|183394558|SUPERIORITY|||||||0.7396|||||||Kolmogorov-Smirnoff|||||||0.7396
91750729|NCT04948307|183394559|SUPERIORITY|||||||0.871|||||||Kolmogorov-Smirnoff|||||||0.8710
91750730|NCT04948307|183394560|SUPERIORITY|||||||0.8816|||||||Kolmogorov-Smirnoff|||||||0.8816
91750731|NCT04948307|183394561|SUPERIORITY|||||||0.5281|||||||Chi-squared|||||||0.5281
91750732|NCT04948307|183394562|SUPERIORITY|||||||0.2996|||||||Chi-squared|||||||0.2996
91750733|NCT04948307|183394566|SUPERIORITY|||||||0.7201|||||||Kolmogorov-Smirnoff|||||||0.7201
91750734|NCT04948307|183394568|OTHER|||||||||||||||||Summary statistics are presented.|Summary statistics are presented|||
91750735|NCT04948307|183394570|OTHER||||||||||||||||||Summary statistics are presented.|||
91750736|NCT03131596|183394577|SUPERIORITY|||||||0.012||||||The p-value is not adjusted and a p-value of \< 0.05 is considered statistically significant.|Chi-squared|||200 patients were eligible and randomised in a 1:1 fashion. 9 patients did not complete the full protocol, resulting in 94 cases in the balloon group and 97 cases in the control group included in the final analysis. Intention-to-treat analysis was conducted.The null hypothesis is the percentage of the patients with reformed uterine adhesion in balloon group will less than the percentage of the patients with reformed uterine adhesion in control group. A Chi-squared analysis was used.||||0.012
91750737|NCT03131596|183394578|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91750738|NCT03131596|183394579|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91750739|NCT03131596|183394580|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
91750740|NCT00734071|183394581|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.911||0.518|TWO_SIDED|95.0|-1.2|2.38||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||2.38|-1.20|0.518
91750741|NCT00734071|183394582|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.542||0.685|TWO_SIDED|95.0|-1.29|0.85||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05).||0.85|-1.29|0.685
91750742|NCT00734071|183394583|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.984|TWO_SIDED|95.0|-0.27|0.28||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||0.28|-0.27|0.984
91750743|NCT00734071|183394584|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.866||0.703|TWO_SIDED|95.0|-1.38|2.04||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||2.04|-1.38|0.703
91750744|NCT00734071|183394585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.602|TWO_SIDED|95.0|0.713|1.795|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.795|0.713|0.602
91750745|NCT00734071|183394586|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.558||0.995|TWO_SIDED|95.0|-3.09|3.07||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||3.07|-3.09|0.995
91750746|NCT00734071|183394587|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|2.951||0.731|TWO_SIDED|95.0|-4.79|6.83||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||6.83|-4.79|0.731
91750747|NCT03654885|183394606|NON_INFERIORITY|By assuming the margin of non-inferiority at 24%, the null hypothesis for this non-inferiority testing was to be set up as XEN implanted group (P1)-Trabeculectomy group (P2) ≤-0.24 versus the alternative hypothesis as P1-P2 \>-0.24. Equivalently, non-inferiority of P1 to P2 was to be declared if the lower limit of the 2-sided confidence interval (CI) of the difference of the above endpoint between the two treatment groups computed using normal approximation was found to be greater than -24%.|Percentage Difference|-6.1||||0.487|TWO_SIDED|95.0|-22.9|10.8|||Chi-squared|||||10.8|-22.9|0.487
91506032|NCT03373383|182882466|SUPERIORITY||Odds Ratio (OR)|1.91|||=|0.079|TWO_SIDED|95.0|0.93|3.93||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.93|0.93|=0.079
91506033|NCT03373383|182882466|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.338|TWO_SIDED|95.0|0.68|3.02||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.02|0.68|=0.338
91506034|NCT03373383|182882466|SUPERIORITY||Odds Ratio (OR)|1.88|||=|0.087|TWO_SIDED|95.0|0.91|3.87||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.87|0.91|=0.087
91506035|NCT03373383|182882467|OTHER||Median Difference (Net)|7.4|||=|0.316|TWO_SIDED|95.0|-6.59|21.89||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.89|-6.59|=0.316
91506036|NCT03373383|182882467|OTHER||Median Difference (Net)|9.99|||=|0.133|TWO_SIDED|95.0|-3.15|23.26||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||23.26|-3.15|=0.133
91506037|NCT03373383|182882467|OTHER||Median Difference (Net)|8.19|||=|0.203|TWO_SIDED|95.0|-3.95|21.37||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.37|-3.95|=0.203
91532241|NCT02325713|182941065|SUPERIORITY_OR_OTHER||Geometric LS mean ration|18.4|||||TWO_SIDED|90.0|15.3|22.0||||||||22.0|15.3|
91532242|NCT02325713|182941065|SUPERIORITY_OR_OTHER||Geometric LS mean ration|222.7|||||TWO_SIDED|90.0|186.8|265.6||||||||265.6|186.8|
91532243|NCT02325713|182941065|SUPERIORITY_OR_OTHER||Geometric LS mean ration|238.1|||||TWO_SIDED|90.0|198.7|285.3||||||||285.3|198.7|
91506038|NCT03373383|182882467|OTHER||Median Difference (Net)|2.39|||=|0.784|TWO_SIDED|95.0|-13.65|17.79||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||17.79|-13.65|=0.784
91506039|NCT03317431|182882471|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.||||<0.01
91506040|NCT03317431|182882472|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.||||>0.01
91506041|NCT03317431|182882473|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with TH expression.||||>0.01
91506042|NCT03317431|182882474|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DDC expression.||||>0.01
91506043|NCT03317431|182882475|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.||||<0.01
91506044|NCT00544076|182882493|EQUIVALENCE|The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,|||||>|0.1||||||no adjustments were made.|Fisher Exact|||||||>0.1
91506045|NCT00544076|182882494|OTHER||||||>|0.1||||||no adjustments done|Chi-squared|no adjustments||compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)||||>0.1
91532244|NCT02325713|182941065|SUPERIORITY_OR_OTHER||Geometric LS mean ration|82.1|||||TWO_SIDED|90.0|68.5|98.3||||||||98.3|68.5|
91532245|NCT02941146|182941110|OTHER||sucess proportion|64.3|||||TWO_SIDED|95.0|35.1|87.2||||||||87.2|35.1|
91532246|NCT02331940|182941123|SUPERIORITY_OR_OTHER|||||||0.88||||||p\<0.05 was considered statistically significant|t-test, 1 sided|||||||0.88
91506046|NCT00544076|182882495|OTHER||||||>|0.2||||||no adjustments done.|ANOVA|||||||>0.2
91532247|NCT01450943|182941127|SUPERIORITY||Odds Ratio (OR)|2.712595||||0.0517|TWO_SIDED|95.0|0.9141|8.4839|||Fisher Exact|||||8.4839|0.9141|0.0517
91532248|NCT01450943|182941128|SUPERIORITY||Odds Ratio (OR)|0.812339||||0.7974|TWO_SIDED|95.0|0.2543|2.5224|||Fisher Exact|||||2.5224|0.2543|0.7974
91532249|NCT02092987|182941147|SUPERIORITY_OR_OTHER_LEGACY||interaction term|||||0.7|||||||Mixed Models Analysis|||Hypothesis testing in changes in mean from baseline to follow-up were were conducted primarily with mixed models. Sensitivity analyses were conducted using ANOVA.||||0.70
91532250|NCT02092987|182941148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||comparison of arms using mixed models|Mixed Models Analysis|||||||0.77
91532251|NCT02092987|182941149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
91532252|NCT02092987|182941150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
91532253|NCT02092987|182941151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
91532254|NCT02092987|182941152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
91532255|NCT02092987|182941153|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
91532256|NCT00951561|182941155|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.|Difference in % of Uses from Mixed Model|-1.6|||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
91506047|NCT00544076|182882496|OTHER||Mean Difference (Final Values)|0.08||||0.08|TWO_SIDED|||||no adjustments|ANOVA|no adjustments for df||"ANOVA test to compare difference of penile length (from baseline to month 18) across arms.~calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken."||||0.08
91506048|NCT02907359|182882497|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6063|TWO_SIDED|95.0|0.74|1.19||OS between Guadecitabine vs Treatment Choice using stratified log-rank test. Due to pre-specified hierarchical testing plan, other endpoints were not evaluated for statistical significance.|Stratified Log-rank test|||||1.19|0.74|0.6063
91506049|NCT00746941|182882549|SUPERIORITY_OR_OTHER|||||||0.7132|||||||Student's t-test|||||||0.7132
91506050|NCT00746941|182882550|SUPERIORITY_OR_OTHER|||||||0.9086|||||||Student's t-test|||||||0.9086
91506051|NCT00176592|182882563|SUPERIORITY|This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.||||<0.05
91506052|NCT02180412|182882574|OTHER||Slope|7.76||||0.0434|TWO_SIDED|95.0|2.14|13.37|||ANCOVA|||ALA Day 1 vs Day 2||13.37|2.14|.0434
91506053|NCT02180412|182882574|OTHER||Slope|16.29||||0.0003|TWO_SIDED|95.0|11.32|21.25|||ANCOVA|||ALA Day 1 vs Day 3||21.25|11.32|.0003
91506054|NCT02180412|182882574|OTHER||Slope|15.98||||0.0198|TWO_SIDED|95.0|6.7|25.26|||ANCOVA|||ALA Day 1 vs Day 4||25.26|6.7|.0198
91506055|NCT02180412|182882574|OTHER||Slope|10.69||||0.158|TWO_SIDED|95.0|-1.67|22.49|||ANCOVA|||PBG Day 1 vs Day 2||22.49|-1.67|.158
91506056|NCT02180412|182882574|OTHER||Slope|24.52||||0.0127|TWO_SIDED|95.0|11.3|37.74|||ANCOVA|||PGB Day 1 vs Day 3||37.74|11.3|.0127
91506057|NCT02180412|182882574|OTHER||Slope|28.45||||0.0328|TWO_SIDED|95.0|9.64|47.27|||ANCOVA|||PBG Day 1 vs Day 4||47.27|9.64|.0328
91506058|NCT02180412|182882574|OTHER||Slope|12.2||||0.9993|TWO_SIDED|95.0|-465.4|489.8|||ANCOVA|||Total Porphyrins Day 1 vs Day 2||489.8|-465.4|.9993
91750748|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-5.81|STANDARD_ERROR_OF_MEAN|1.155|<|0.001|TWO_SIDED|95.0|-8.074|-3.538||Mixed Model for Repeated Measures (MMRM) model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Day 1||-3.538|-8.074|<0.001
91506059|NCT02180412|182882574|OTHER||Slope|454.5||||0.2915|TWO_SIDED|95.0|-200.87|1109.86|||ANCOVA|||Total Porphyrins Day 1 vs Day 3||1109.86|-200.87|.2915
91506060|NCT02180412|182882574|OTHER||Slope|326.12||||0.4382|TWO_SIDED|95.0|-292.0|944.25|||ANCOVA|||Total Porphyrins Day 1 vs Day 4||944.25|-292|.4382
91506061|NCT04654117|182882578|SUPERIORITY|Multilevel model predicting the effect of the overall consultation model on manual adherence, averaged across clinicians.|unstandardized beta|0.33|STANDARD_ERROR_OF_MEAN|3.85|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
91506062|NCT04654117|182882579|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
91532257|NCT02967016|182941156|OTHER|||||||0.002|||||||Kruskal-Wallis|||Cumulative Steps 6 h||||0.002
91506063|NCT04654117|182882580|OTHER|multilevel modeling|multilevel modeling|2.56|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||multilevel modeling|||||||<.05
91506064|NCT04654117|182882581|SUPERIORITY||ANOVA|17.0|||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
91506065|NCT04654117|182882582|OTHER|multilevel model|multilevel model|0.04|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
91506066|NCT04654117|182882583|OTHER|multilevel model|multilevel model (beta)|-0.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
91506067|NCT01354496|182882584|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.03|||||TWO_SIDED|90.0|0.897|1.18|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.18|0.897|
91506068|NCT01354496|182882585|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.06|||||TWO_SIDED|90.0|0.922|1.22|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.22|0.922|
91506069|NCT01354496|182882586|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.896|1.16|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.16|0.896|
91506070|NCT01354496|182882587|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.882|1.15|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.15|0.882|
91506071|NCT01354496|182882589|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.993|||||TWO_SIDED|90.0|0.951|1.04|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.951|
91506072|NCT01354496|182882589|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.905|0.983|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.983|0.905|
91506073|NCT01354496|182882590|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.98|||||TWO_SIDED|90.0|0.926|1.04|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.926|
91506074|NCT01354496|182882590|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.94|||||TWO_SIDED|90.0|0.891|0.993|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.993|0.891|
91532258|NCT02967016|182941156|OTHER|||||||0.0002|||||||Kruskal-Wallis|||Cumulative steps 12 h||||.0002
91532259|NCT02967016|182941156|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 24 h||||.0006
91532260|NCT02967016|182941156|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 36 h||||0.0006
91532261|NCT02967016|182941156|OTHER|||||||0.03|||||||Kruskal-Wallis|||Cumulative steps 48 h||||0.03
91532262|NCT02967016|182941157|OTHER|||||||0.06|||||||Kruskal-Wallis|||Pain at rest 6 h||||0.06
91532263|NCT02967016|182941157|OTHER|||||||0.3|||||||Kruskal-Wallis|||Pain at rest 12 h||||.30
91532264|NCT02967016|182941157|OTHER|||||||0.002|||||||Kruskal-Wallis|||Pain at rest 24 h||||.002
91750749|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.163||0.851|TWO_SIDED|95.0|-2.503|2.066||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 1||2.066|-2.503|0.851
91506075|NCT01774786|182882622|SUPERIORITY|The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.|Hazard Ratio (HR)|0.84||||0.0565|TWO_SIDED|95.0|0.71|1.0||The actual p-value significance threshold required for OS was 0.0455, after alpha spent at the interim analysis was taken into account.|Stratified Log-Rank|Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|HR was calculated as pertuzumab arm vs. placebo arm.|Primary Analysis. The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.||1.00|0.71|0.0565
91750750|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.03|STANDARD_ERROR_OF_MEAN|1.162||0.081|TWO_SIDED|95.0|-0.253|4.309||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 2||4.309|-0.253|0.081
91750751|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.21|STANDARD_ERROR_OF_MEAN|1.157||0.056|TWO_SIDED|95.0|-0.059|4.484||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 1||4.484|-0.059|0.056
91750752|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|4.74|STANDARD_ERROR_OF_MEAN|1.181|<|0.001|TWO_SIDED|95.0|2.416|7.054||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 3||7.054|2.416|<0.001
91750753|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.01|STANDARD_ERROR_OF_MEAN|1.197||0.012|TWO_SIDED|95.0|0.657|5.358||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 6||5.358|0.657|0.012
91750754|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.53|STANDARD_ERROR_OF_MEAN|1.197||0.003|TWO_SIDED|95.0|1.182|5.883||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 9||5.883|1.182|0.003
91750755|NCT03654885|183394608|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 12||5.183|0.358|0.024
91750756|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.505|TWO_SIDED|95.0|-0.36|0.18||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1||0.18|-0.36|0.505
91750757|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.949|TWO_SIDED|95.0|-0.28|0.26||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1||0.26|-0.28|0.949
91750758|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.581|TWO_SIDED|95.0|-0.19|0.34||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2||0.34|-0.19|0.581
91506076|NCT01774786|182882622|OTHER|Exploratory|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.72|0.99|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.99|0.72|
91506077|NCT01774786|182882623|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.86||As pre-specified in the protocol, a p-value was only to be calculated for PFS if OS was statistically significant.|||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Primary Analysis||0.86|0.62|
91506078|NCT01774786|182882623|OTHER|Exploratory|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.85|||||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Final Analysis||0.85|0.62|
91532265|NCT02967016|182941157|OTHER|||||||0.003|||||||Kruskal-Wallis|||Pain at rest 36 h||||0.003
91532266|NCT02967016|182941157|OTHER|||||||0.02|||||||Kruskal-Wallis|||Pain at rest at 48 h||||.02
91750759|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.302|TWO_SIDED|95.0|-0.13|0.41||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1||0.41|-0.13|0.302
91750760|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|0.12|0.66||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3||0.66|0.12|0.005
91506079|NCT01774786|182882624|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Primary Analysis of Objective Response Rate||15.91|0.89|
91506080|NCT01774786|182882624|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Primary Analysis of Objective Response Rate||1.89|1.04|
91506081|NCT01774786|182882625|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Final Analysis of Objective Response Rate||15.91|0.89|
91506082|NCT01774786|182882625|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Final Analysis of Objective Response Rate||1.89|1.04|
91506083|NCT01774786|182882626|OTHER|Exploratory|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.64|1.06|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Primary Analysis||1.06|0.64|
91506084|NCT01774786|182882626|OTHER|Exploratory|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|0.98|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.98|0.62|
91750761|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.026|TWO_SIDED|95.0|0.04|0.59||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6||0.59|0.04|0.026
91750762|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|95.0|0.09|0.64||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9||0.64|0.09|0.010
91506085|NCT01774786|182882627|OTHER|Exploratory|Difference in Clinical Benefit Rate|3.37|||||TWO_SIDED|95.0|-2.34|9.07|||||Difference in clinical benefit rate was calculated as the pertuzumab arm minus placebo arm.|||9.07|-2.34|
91506086|NCT01774786|182882627|OTHER|Exploratory|Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.88|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|||1.88|0.86|
91506087|NCT05045144|182882647|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.92|1.13|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 2 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.13|0.92|
91506088|NCT05045144|182882647|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.05|0.85|
91506089|NCT05045144|182882647|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.83|1.03|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 2 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.03|0.83|
91506090|NCT05045144|182882648|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for the A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.63|0.82|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||0.82|0.63|
91506091|NCT05045144|182882648|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Washington/02/2019 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.79|1.1|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||1.10|0.79|
91506092|NCT05045144|182882648|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Phuket/3073/2013 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||0.93|0.69|
91506093|NCT05045144|182882649|NON_INFERIORITY|The non-inferiority of RSV MAT vaccine is demonstrated for RSV A neutralizing antibody titers, if the LL of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by RSV MAT vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97|||GMC ratio|||To demonstrate the immunological non-inferiority of the RSV MAT vaccine when co-administered with Flu D-QIV vaccine, compared to RSV MAT vaccine given alone as measured by the ratio of GMTs of RSV A neutralizing antibody titers at 30 days post administration (Day 31).||0.97|0.78|
91532267|NCT02967016|182941158|OTHER|||||||0.43|||||||Kruskal-Wallis|||Satisfaction with pain control 6 h||||.43
91532268|NCT02967016|182941158|OTHER|||||||0.24|||||||Kruskal-Wallis|||Satisfaction with pain control 12 h||||.24
91506094|NCT05045144|182882650|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|3.44|||||TWO_SIDED|95.0|-3.44|10.29|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||10.29|-3.44|
91750763|NCT03654885|183394610|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12||0.54|0.00|0.052
91750764|NCT03654885|183394611|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||5.183|0.358|0.024
91506095|NCT05045144|182882650|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Washington/02/2019 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.15|||||TWO_SIDED|95.0|-2.04|10.32|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||10.32|-2.04|
91532269|NCT02967016|182941158|OTHER|||||||0.012|||||||Kruskal-Wallis|||Satisfaction with pain control 24 h||||.012
91532270|NCT02967016|182941158|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Satisfaction with pain control 36 h||||<0.0001
91750765|NCT03654885|183394612|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.54|0.00|0.052
91750766|NCT03654885|183394613|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|2.214||0.421|TWO_SIDED|95.0|-2.579|6.151||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed model repeated measures|||||6.151|-2.579|0.421
91532271|NCT02967016|182941158|OTHER|||||||0.0005|||||||Kruskal-Wallis|||Satisfaction with pain control 48 h||||.0005
91532272|NCT04365413|182941207|OTHER||Median Difference (Final Values)|0.069|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
91532273|NCT04365413|182941208|OTHER||Median Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
91532274|NCT03566680|182941242|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91506096|NCT05045144|182882650|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Phuket/3073/2013 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.08|||||TWO_SIDED|95.0|-2.46|10.58|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||10.58|-2.46|
91506097|NCT04544293|182882658|SUPERIORITY||Mean Difference (Net)|6.0||||0.0007|TWO_SIDED|95.0|2.5|9.4|||Mixed Models Analysis|Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Difference from placebo|||9.4|2.5|0.0007
91532275|NCT03566680|182941243|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91750767|NCT03654885|183394614|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.18|TWO_SIDED|95.0|-0.16|0.84||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.84|-0.16|0.180
91750768|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.7||||0.064|TWO_SIDED|95.0|-33.0|2.3|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHg||2.3|-33.0|0.064
91750769|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.3||||0.078|TWO_SIDED|95.0|-32.7|2.5|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHg||2.5|-32.7|0.078
91750770|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.4||||0.051|TWO_SIDED|95.0|-34.7|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHg||0.4|-34.7|0.051
91750771|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-16.9||||0.064|TWO_SIDED|95.0|-34.1|1.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHg||1.0|-34.1|0.064
91750772|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.1||||0.2|TWO_SIDED|95.0|-30.5|4.8|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hg||4.8|-30.5|0.200
91750773|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.0||||0.042|TWO_SIDED|95.0|-37.1|-2.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hg||-2.0|-37.1|0.042
91750774|NCT03654885|183394615|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hg||5.2|-30.1|0.180
91750775|NCT03654885|183394616|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-3.6||||0.712|TWO_SIDED|95.0|-21.3|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reduction||14.2|-21.3|0.712
91750776|NCT03654885|183394616|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.9||||0.201|TWO_SIDED|95.0|-30.3|5.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reduction||5.0|-30.3|0.201
91750777|NCT03654885|183394616|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.3||||0.03|TWO_SIDED|95.0|-37.3|-2.3|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reduction||-2.3|-37.3|0.030
91750778|NCT03654885|183394616|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-18.8||||0.043|TWO_SIDED|95.0|-36.0|-0.8|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reduction||-0.8|-36.0|0.043
91750779|NCT03654885|183394616|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.9||||0.048|TWO_SIDED|95.0|-35.1|0.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reduction||0.0|-35.1|0.048
91532276|NCT03566680|182941244|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91532277|NCT03566680|182941245|EQUIVALENCE|||||||0.73|||||||t-test, 2 sided|||||||0.73
91532278|NCT03566680|182941246|EQUIVALENCE|||||||0.08|||||||t-test, 2 sided|||||||0.08
91532279|NCT03566680|182941247|EQUIVALENCE|||||||0.72|||||||t-test, 2 sided|||||||0.72
91506098|NCT04544293|182882659|SUPERIORITY||Mean Difference (Net)|6.9||||0.0008|TWO_SIDED|95.0|2.9|10.9||Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Mixed Models Analysis||Difference from Placebo|||10.9|2.9|0.0008
91506099|NCT04544293|182882660|SUPERIORITY||Mean Difference (Net)|-6.59||||0.0072|TWO_SIDED|95.0|-11.4|-1.79|||Mixed Models Analysis|||||-1.79|-11.40|0.0072
91506100|NCT04544293|182882661|SUPERIORITY||Mean Difference (Net)|-7.81||||0.0149|TWO_SIDED|95.0|-14.1|-1.52|||Mixed Models Analysis|||||-1.52|-14.10|0.0149
91750780|NCT03654885|183394616|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.1||||0.015|TWO_SIDED|95.0|-38.1|-3.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reduction||-3.2|-38.1|0.015
91750781|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.7||||0.252|TWO_SIDED|95.0|-29.0|6.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤18 mm Hg||6.3|-29.0|0.252
91750782|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.5||||0.258|TWO_SIDED|95.0|-28.9|6.5|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤17 mmHg||6.5|-28.9|0.258
91750783|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.6||||0.139|TWO_SIDED|95.0|-30.9|4.4|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤16 mm Hg||4.4|-30.9|0.139
91750784|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.7||||0.136|TWO_SIDED|95.0|-32.0|3.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤15 mm Hg||3.3|-32.0|0.136
91750785|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.%.|Percentage Difference|-10.8||||0.274|TWO_SIDED|95.0|-28.2|7.1|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤14 mm Hg||7.1|-28.2|0.274
91750786|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.7||||0.065|TWO_SIDED|95.0|-35.0|0.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤13 mm Hg||0.3|-35.0|0.065
91750787|NCT03654885|183394617|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤12 mmHg||5.2|-30.1|0.180
91750788|NCT03654885|183394620|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|1.8||||1|TWO_SIDED|95.0|-41.6|44.1|||Fisher Exact|||||44.1|-41.6|1.000
91750789|NCT03654885|183394621|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-32.1||||0.215|TWO_SIDED|95.0|-66.8|10.0|||Fisher Exact|||||10.0|-66.8|0.215
91750790|NCT03654885|183394623|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.9||||0.144|TWO_SIDED|95.0|-32.2|3.1|||Fisher Exact|||||3.1|-32.2|0.144
91750791|NCT03654885|183394624|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-10.6||||0.254|TWO_SIDED|95.0|-28.0|7.3|||Fisher Exact|||||7.3|-28.0|0.254
91750792|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-7.4||||0.563|TWO_SIDED|95.0|-28.6|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hg||14.2|-28.6|0.563
91750793|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.5||||0.188|TWO_SIDED|95.0|-33.5|9.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hg||9.1|-33.5|0.188
91750794|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.9||||0.118|TWO_SIDED|95.0|-36.7|5.6|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHg||5.6|-36.7|0.118
91506101|NCT04544293|182882662|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0845|TWO_SIDED|95.0|-0.06|0.89|||Mixed Models Analysis|||||0.89|-0.06|0.0845
91506102|NCT04544293|182882663|SUPERIORITY||Mean Difference (Net)|-4.87||||0.1046|TWO_SIDED|95.0|-10.76|1.01|||Mixed Models Analysis|||||1.01|-10.76|0.1046
91506103|NCT04544293|182882664|SUPERIORITY||Mean Difference (Net)|-5.99||||0.1216|TWO_SIDED|95.0|-13.57|1.59|||Mixed Models Analysis|||||1.59|-13.57|0.1216
91506104|NCT04544293|182882665|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.0234|TWO_SIDED|95.0|0.07|1.03|||Mixed Models Analysis||Change from baseline compared to placebo.|||1.03|0.07|0.0234
91506105|NCT04544293|182882666|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.1043|TWO_SIDED|95.0|-8.84|0.83|||Mixed Models Analysis|||||0.83|-8.84|0.1043
91513413|NCT02328326|182898542|SUPERIORITY||Mean Difference (Net)|0.11||||0.79|TWO_SIDED|95.0|-0.71|0.93|||Regression, Linear|Model was adjusted for baseline value of PEPPI, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.||0.93|-0.71|0.79
91750795|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.5||||0.085|TWO_SIDED|95.0|-40.2|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hg||2.1|-40.2|0.085
91750796|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.3||||0.059|TWO_SIDED|95.0|-42.0|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hg||0.4|-42.0|0.059
91750797|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.5||||0.045|TWO_SIDED|95.0|-43.9|-1.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hg||-1.4|-43.9|0.045
91750798|NCT03654885|183394625|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.8||||0.076|TWO_SIDED|95.0|-41.3|1.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hg||1.1|-41.3|0.076
91750799|NCT03654885|183394626|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-9.6||||0.464|TWO_SIDED|95.0|-31.0|12.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reduction||12.1|-31.0|0.464
91750800|NCT03654885|183394626|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.8||||0.069|TWO_SIDED|95.0|-40.6|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reduction||2.1|-40.6|0.069
91750801|NCT03654885|183394626|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-26.6||||0.023|TWO_SIDED|95.0|-46.9|-4.7|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reduction||-4.7|-46.9|0.023
91750802|NCT03654885|183394626|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.7||||0.046|TWO_SIDED|95.0|-43.9|-1.6|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reduction||-1.6|-43.9|0.046
91750803|NCT03654885|183394626|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-27.6||||0.014|TWO_SIDED|95.0|-47.6|-5.9|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reduction||-5.9|-47.6|0.014
91750804|NCT03654885|183394626|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-30.9||||0.006|TWO_SIDED|95.0|-50.8|-9.5|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reduction||-9.5|-50.8|0.006
91750805|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|0.33|1.72|||Mixed Model for Repeated Measures|MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1||1.72|0.33|0.004
91750806|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|0.47|1.88||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1||1.88|0.47|0.001
91750807|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.162|TWO_SIDED|95.0|-0.2|1.2||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2||1.20|-0.20|0.162
91506106|NCT00744627|182882674|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.81|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-5.74|-1.88||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-1.88|-5.74|<0.001
91506107|NCT00744627|182882675|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.555|<|0.001|TWO_SIDED|95.0|-3.39|-1.2||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis||||-1.20|-3.39|<0.001
91506108|NCT00744627|182882676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.73|-0.19||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.19|-0.73|<0.001
91506109|NCT00744627|182882677|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.901||0.031|TWO_SIDED|95.0|-3.74|-0.18||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.18|-3.74|0.031
91506110|NCT00744627|182882678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.393|||<|0.001|TWO_SIDED|95.0|1.496|3.83||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||3.830|1.496|<0.001
91506111|NCT00744627|182882679|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.267|<|0.001|TWO_SIDED|95.0|-7.61|-2.6||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-2.60|-7.61|<0.001
91506112|NCT00744627|182882680|SUPERIORITY_OR_OTHER||LS Mean Difference|8.78|STANDARD_ERROR_OF_MEAN|2.774||0.002|TWO_SIDED|95.0|3.32|14.25||SF-36 social functioning subscore was the last endpoint to be tested in the hierarchical testing sequence.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||Results presented are for the number of participants at week 8 only.||14.25|3.32|0.002
91506113|NCT04809220|182882702|SUPERIORITY||LS Mean Difference|-0.29|||<|0.001|TWO_SIDED|95.0|-0.43|-0.14|||Mixed Models Analysis|||||-0.14|-0.43|<.001
91506114|NCT04809220|182882703|SUPERIORITY||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<.001
91506115|NCT04809220|182882704|SUPERIORITY||Odds Ratio (OR)|1.15||||0.56|TWO_SIDED|95.0|0.71|1.87|||Generalized Linear Mixed Model (GLM)|||For HbA1c ≤6.5%||1.87|0.71|0.560
91506116|NCT04809220|182882704|SUPERIORITY||Odds Ratio (OR)|1.61||||0.028|TWO_SIDED|95.0|1.05|2.45|||Generalized Linear Mixed Model (GLM)|||For HbA1c \< 7%||2.45|1.05|0.028
91506117|NCT04809220|182882705|SUPERIORITY||LS Mean Difference|-9.4|||<|0.001|TWO_SIDED|95.0|-14.4|-4.3|||Mixed Models Analysis|||||-4.3|-14.4|<.001
91506118|NCT04809220|182882706|SUPERIORITY||LS Mean Difference|-7.2||||0.002|TWO_SIDED|95.0|-11.7|-2.7|||ANCOVA|||Morning premeal-fasting||-2.7|-11.7|0.002
91506119|NCT04809220|182882706|SUPERIORITY||LS Mean Difference|-10.1||||0.016|TWO_SIDED|95.0|-18.3|-1.9|||ANCOVA|||Morning 2-hour post meal||-1.9|-18.3|0.016
91506120|NCT04809220|182882706|SUPERIORITY||LS Mean Difference|-8.3||||0.007|TWO_SIDED|95.0|-14.2|-2.3|||ANCOVA|||Midday premeal||-2.3|-14.2|0.007
91506121|NCT04809220|182882706|SUPERIORITY||LS Mean Difference|-12.5||||0.002|TWO_SIDED|95.0|-20.5|-4.5|||ANCOVA|||Midday 2-hour post meal||-4.5|-20.5|0.002
91506122|NCT04809220|182882706|SUPERIORITY||LS Mean Difference|-3.9||||0.158|TWO_SIDED|95.0|-9.3|1.5|||ANCOVA|||Evening premeal||1.5|-9.3|0.158
91750808|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.185|TWO_SIDED|95.0|-0.23|1.19||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1||1.19|-0.23|0.185
91750809|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.846|TWO_SIDED|95.0|-0.64|0.79||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3||0.79|-0.64|0.846
91750810|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.965|TWO_SIDED|95.0|-0.73|0.7||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6||0.70|-0.73|0.965
91750811|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.37||0.096|TWO_SIDED|95.0|-0.11|1.33||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9||1.33|-0.11|0.096
91506123|NCT04809220|182882706|SUPERIORITY||LS Mean Difference|-11.3||||0.004|TWO_SIDED|95.0|-19.0|-3.7|||ANCOVA|||Evening 2-hour post meal||-3.7|-19.0|0.004
91506124|NCT04809220|182882707|SUPERIORITY||LS Mean Difference|-0.3||||0.213|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||||0.2|-0.8|0.213
91506125|NCT02968979|182882738|OTHER|||||||0.0032|||||||likelihood-ratio test|||Statistical analysis applies to all rows and columns.||||0.0032
91506126|NCT02968979|182882738|OTHER|||||||0.0008|||||||Chi-squared|||"Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.~Statistical analysis applies to all rows and columns."||||0.0008
91750812|NCT03654885|183394633|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.063|TWO_SIDED|95.0|-0.04|1.43||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12||1.43|-0.04|0.063
91750813|NCT03654885|183394634|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.027||0.048|TWO_SIDED|95.0|-0.105|0.0|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1||0.000|-0.105|0.048
91750814|NCT03654885|183394634|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.742|TWO_SIDED|95.0|-0.062|0.045|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3||0.045|-0.062|0.742
91750815|NCT03654885|183394634|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.027||0.925|TWO_SIDED|95.0|-0.056|0.051|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6||0.051|-0.056|0.925
91506127|NCT02968979|182882748|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
91506128|NCT02968979|182882748|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
91506129|NCT02968979|182882748|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
91506130|NCT02968979|182882748|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
91506131|NCT02968979|182882748|OTHER|||||||0.1085|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||0.1085
91506132|NCT02968979|182882748|OTHER|||||||0.0482||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||0.0482
91506133|NCT02968979|182882748|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
91506134|NCT02968979|182882748|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
91532280|NCT04227340|182941252|OTHER|The count, percentage and confidence interval will be calculated for allogeneic HCT patients who receive PBM and develop Grade 3 mucositis|Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.091|0.356|||||Odds of grade 3 in Allogeneic group compared to historical rates. The study efficacy of mucositis reduction by 20% with an estimation of 51% developing grade 3 mucositis.|The count, percentage and confidence interval were calculated for allogeneic HCT participants who receive PBM and developed Grade 3 mucositis. Whether the percentage of the prospective sample is significantly different from the estimated rate of 71% was accessed.||0.356|0.091|
91750816|NCT03654885|183394634|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.028||0.021|TWO_SIDED|95.0|-0.118|-0.01|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12||-0.010|-0.118|0.021
91506135|NCT02968979|182882748|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
91532281|NCT04227340|182941253|SUPERIORITY|||||||0.03|||||||Wilcox Rank Sum|||||||0.03
91506136|NCT02968979|182882748|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
91506137|NCT00729183|182882762|SUPERIORITY_OR_OTHER||Difference in LS Means|3.49|||<|0.001|TWO_SIDED|95.0|2.66|4.32|||Longitudinal Data Analysis (LDA) Model|||A longitudinal ANCOVA was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% confidence interval (CI). The model, applied on all time points during treatment (Screening Visit \[BL\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted Least Squares (LS) mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||4.32|2.66|<0.001
91506138|NCT00729183|182882763|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.2|||||TWO_SIDED|95.0|-12.3|7.9||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||7.9|-12.3|
91506139|NCT00729183|182882764|SUPERIORITY_OR_OTHER||Difference in Percentage|4.4|||||TWO_SIDED|95.0|-3.2|12.3||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||12.3|-3.2|
91506140|NCT00729183|182882765|SUPERIORITY_OR_OTHER||Difference in LS Means|5.39|||<|0.001|TWO_SIDED|95.0|4.36|6.42|||LDA|||A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted LS mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||6.42|4.36|<0.001
91506141|NCT00729183|182882766|SUPERIORITY_OR_OTHER||Difference in LS Means|1.57|||<|0.001|TWO_SIDED|95.0|0.88|2.25|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.25|0.88|<0.001
91506142|NCT00729183|182882766|SUPERIORITY_OR_OTHER||Difference in LS Means|3.32|||<|0.001|TWO_SIDED|95.0|2.39|4.26|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.26|2.39|<0.001
91532282|NCT04227340|182941255|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91532283|NCT04227340|182941257|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91532284|NCT04227340|182941259|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.1
91532285|NCT04227340|182941261|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91750817|NCT03654885|183394637|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.562|STANDARD_ERROR_OF_MEAN|0.3231||0.087|TWO_SIDED|95.0|-1.2082|0.0851|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1||0.0851|-1.2082|0.087
91750818|NCT03654885|183394637|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.3355||0.682|TWO_SIDED|95.0|-0.809|0.5324|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1||0.5324|-0.8090|0.682
91506143|NCT00729183|182882767|SUPERIORITY_OR_OTHER||Difference in LS Means|1.48||||0.001|TWO_SIDED|95.0|0.6|2.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.35|0.60|0.001
91506144|NCT00729183|182882767|SUPERIORITY_OR_OTHER||Difference in LS Means|3.81|||<|0.001|TWO_SIDED|95.0|2.69|4.93|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.93|2.69|<0.001
91506145|NCT00729183|182882768|SUPERIORITY_OR_OTHER||Difference in LS Means|2.19|||<|0.001|TWO_SIDED|95.0|1.09|3.29|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||3.29|1.09|<0.001
91506146|NCT00729183|182882768|SUPERIORITY_OR_OTHER||Difference in LS Means|5.48|||<|0.001|TWO_SIDED|95.0|4.08|6.89|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||6.89|4.08|<0.001
91506147|NCT00729183|182882769|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||1.35|0.07|0.030
91506148|NCT00729183|182882769|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7|||<|0.001|TWO_SIDED|95.0|0.97|2.43|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.43|0.97|<0.001
91506149|NCT00729183|182882770|SUPERIORITY_OR_OTHER||Difference in LS Means|1.71||||0.001|TWO_SIDED|95.0|0.69|2.73|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.73|0.69|0.001
91506150|NCT00729183|182882770|SUPERIORITY_OR_OTHER||Difference in LS Means|2.7|||<|0.001|TWO_SIDED|95.0|1.62|3.78|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||3.78|1.62|<0.001
91532286|NCT04003974|182941263|OTHER|Mean DUX4 activity was derived for each participant at each time point (Baseline and post-Baseline) based on normalized gene expression values for the 6-gene panel. Changes from Baseline to post-Baseline were analyzed using an ANCOVA model.|Least square mean difference|0.4284||||0.5621|TWO_SIDED|95.0|-1.0376|1.8945|||ANCOVA||Results are expressed as difference in Least-Squares (LS) means of the changes from Baseline to post-Baseline in DUX4 activity for each group, losmapimod and placebo.|||1.8945|-1.0376|0.5621
91750819|NCT03654885|183394637|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.452|STANDARD_ERROR_OF_MEAN|0.3484||0.199|TWO_SIDED|95.0|-1.1483|0.2434|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12||0.2434|-1.1483|0.199
91750820|NCT03654885|183394638|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.001|STANDARD_ERROR_OF_MEAN|0.2026||0.997|TWO_SIDED|95.0|-0.4103|0.4086|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1||0.4086|-0.4103|0.997
91506151|NCT00729183|182882771|SUPERIORITY_OR_OTHER||Difference in LS Means|0.16||||0.697|TWO_SIDED|95.0|-0.63|0.95|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||0.95|-0.63|0.697
91506152|NCT00729183|182882771|SUPERIORITY_OR_OTHER||Difference in LS Means|1.22||||0.013|TWO_SIDED|95.0|0.27|2.18|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.18|0.27|0.013
91506153|NCT00729183|182882772|SUPERIORITY_OR_OTHER||Difference in LS Means|8.01|||<|0.001|TWO_SIDED|95.0|6.03|9.99|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||9.99|6.03|<0.001
91506154|NCT00729183|182882772|SUPERIORITY_OR_OTHER||Difference in LS Means|11.46|||<|0.001|TWO_SIDED|95.0|8.96|13.97|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||13.97|8.96|<0.001
91506155|NCT00729183|182882773|SUPERIORITY_OR_OTHER||Difference in LS Means|5.68|||<|0.001|TWO_SIDED|95.0|3.77|7.58|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||7.58|3.77|<0.001
91506156|NCT00729183|182882773|SUPERIORITY_OR_OTHER||Difference in LS Means|9.38|||<|0.001|TWO_SIDED|95.0|6.98|11.77|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||11.77|6.98|<0.001
91532287|NCT02400307|182941282|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|Geometric Least-Square Mean (GLSM) Ratio|72.63|||||TWO_SIDED|90.0|48.8|108.1||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.10|48.80|
91506157|NCT00729183|182882774|SUPERIORITY_OR_OTHER||Difference in LS Means|-54.03|||<|0.001|TWO_SIDED|95.0|-64.81|-43.26|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-43.26|-64.81|<0.001
91506158|NCT00729183|182882774|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.59|||<|0.001|TWO_SIDED|95.0|-62.22|-28.96|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-28.96|-62.22|<0.001
91750821|NCT03654885|183394638|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.2124||0.302|TWO_SIDED|95.0|-0.2068|0.6506|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2||0.6506|-0.2068|0.302
91750822|NCT03654885|183394639|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.343|STANDARD_ERROR_OF_MEAN|0.3336||0.309|TWO_SIDED|95.0|-0.3289|1.0154|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Day 1||1.0154|-0.3289|0.309
91750823|NCT03654885|183394639|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.261|STANDARD_ERROR_OF_MEAN|0.3278||0.43|TWO_SIDED|95.0|-0.3993|0.922|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Week 2||0.9220|-0.3993|0.430
91750824|NCT03654885|183394639|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|0.4457||0.363|TWO_SIDED|95.0|-1.3071|0.4882|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Day 1||0.4882|-1.3071|0.363
91750825|NCT03654885|183394639|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.488|STANDARD_ERROR_OF_MEAN|0.4383||0.272|TWO_SIDED|95.0|-1.3709|0.3954|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Week 2||0.3954|-1.3709|0.272
91750826|NCT03654885|183394639|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.765|STANDARD_ERROR_OF_MEAN|0.4502||0.096|TWO_SIDED|95.0|-1.6722|0.142|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Day 1||0.1420|-1.6722|0.096
91750827|NCT03654885|183394639|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.576|STANDARD_ERROR_OF_MEAN|0.4411||0.198|TWO_SIDED|95.0|-1.4655|0.3129|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Week 2||0.3129|-1.4655|0.198
91750828|NCT03654885|183394650|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-3.031|STANDARD_ERROR_OF_MEAN|4.3331||0.485|TWO_SIDED|95.0|-11.5597|5.4973|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Score||5.4973|-11.5597|0.485
91750829|NCT03654885|183394650|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-10.507|STANDARD_ERROR_OF_MEAN|4.5666||0.022|TWO_SIDED|95.0|-19.5|-1.5144|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Score||-1.5144|-19.5000|0.022
91506159|NCT00729183|182882775|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.34|||<|0.001|TWO_SIDED|95.0|-37.77|-12.92|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo.||-12.92|-37.77|<0.001
91506160|NCT00729183|182882775|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.07||||0.225|TWO_SIDED|95.0|-23.69|5.56|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo.||5.56|-23.69|0.225
91506161|NCT05083442|182882783|SUPERIORITY||Mean Difference (Net)|0.8||||0.19|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||1.9|-0.4|0.19
91506162|NCT05083442|182882784|SUPERIORITY||Mean Difference (Net)|0.3||||0.745|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||2.1|-1.5|0.745
91506163|NCT04865354|182882808|NON_INFERIORITY|Noninferiority to be concluded if least squares means difference upper confidence limit is less than 0.05.|Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0034|||ONE_SIDED|95.0||0.009||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.||LSM results based on general linear mixed effects model with terms for lens, period and sequence as fixed effects, subject as a random effect|Difference = PRECISION1 minus Clariti 1-Day|||0.009||
91506164|NCT00110812|182882817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|134.0|||<|0.001|TWO_SIDED|95.0|70.0|198.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||198|70|<.001
91506165|NCT00110812|182882817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|133.0|||<|0.001|TWO_SIDED|95.0|68.0|199.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||199|68|<.001
91532288|NCT02400307|182941283|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.29|||||TWO_SIDED|90.0|79.49|124.04||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||124.04|79.49|
91532289|NCT02400307|182941284|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|72.43|||||TWO_SIDED|90.0|48.54|108.07||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.07|48.54|
91506166|NCT00110812|182882819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.31||||0.01|TWO_SIDED|95.0|0.08|0.54|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.54|.08|.01
91506167|NCT00110812|182882819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36||||0.003|TWO_SIDED|95.0|0.12|0.6|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.60|.12|.003
91506168|NCT00110812|182882820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.8||||0.009||95.0|||||ANOVA|ANOVA with stratification by region and adjustment for baseline CD4||||||.009
91750830|NCT03654885|183394650|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-7.528|STANDARD_ERROR_OF_MEAN|4.0382||0.064|TWO_SIDED|95.0|-15.4841|0.4275|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Score||0.4275|-15.4841|0.064
91506169|NCT00110812|182882820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.2||||0.02||95.0|||||ANOVA|stratified by region and adjusted for baseline CD4||||||.02
91506170|NCT00110812|182882823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.08||||0.14|TWO_SIDED|95.0|0.59|43.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 alone compared to patients not taking IL-2.|||43.6|0.59|.14
91506171|NCT00110812|182882823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.56||||0.08|TWO_SIDED|95.0|0.8|53.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2|||53.6|0.80|.08
91506172|NCT00110812|182882824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.048|TWO_SIDED|95.0|0.34|0.99|||Regression, Cox||IL-2 without ART vs control group|||.99|.34|.048
91506173|NCT00110812|182882824|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.62|||Regression, Cox||IL-2 with pericycle HAART compared to control|||.62|.17|<.001
91506174|NCT00110812|182882825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.03|TWO_SIDED|95.0|0.03|0.64|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.64|0.03|.03
91506175|NCT00110812|182882825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.54|||<|0.001|TWO_SIDED|95.0|0.24|0.85|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.85|0.24|<.001
91506176|NCT00110812|182882828|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.45||||0.59|TWO_SIDED|95.0|0.38|5.45|||Regression, Cox|Stratification by region.|IL-2 group compared to control group|||5.45|0.38|.59
91506177|NCT00110812|182882829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-55.9|STANDARD_ERROR_OF_MEAN|28.4||0.05||95.0|||||ANOVA|Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.|IL-2 group minus control group CD4.|||||.05
91750831|NCT03654885|183394650|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.278|TWO_SIDED|95.0|-1.28|0.37|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Score||0.37|-1.28|0.278
91506178|NCT00110812|182882831|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.03|TWO_SIDED|95.0|0.52|0.97|||Regression, Cox||IL-2 groups vs. control|||.97|.52|.03
91750832|NCT03654885|183394650|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.63||0.007|TWO_SIDED|95.0|-2.96|-0.47|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Score||-0.47|-2.96|0.007
91750833|NCT03654885|183394651|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.534|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at all||||0.534
91750834|NCT03654885|183394651|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.263|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhat||||0.263
91750835|NCT03654885|183394651|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||1|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately so||||1.000
91750836|NCT03654885|183394651|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.018|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostly||||0.018
91750837|NCT03654885|183394651|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.35|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completely||||0.350
91750838|NCT03654885|183394651|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.264|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missing||||0.264
91750839|NCT03654885|183394652|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-8.303|STANDARD_ERROR_OF_MEAN|16.1445||0.61|TWO_SIDED|95.0|-40.8681|24.2624|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Health||24.2624|-40.8681|0.610
91506179|NCT04476030|182882844|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.55||0.0004|TWO_SIDED|95.0|-3.0|-0.9|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.9|-3.0|0.0004
91506180|NCT04476030|182882845|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.56||0.0054|TWO_SIDED|95.0|-2.7|-0.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.5|-2.7|0.0054
91750840|NCT03654885|183394653|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|8.33||0.097|TWO_SIDED|95.0|-30.32|2.52|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Health||2.52|-30.32|0.097
91750841|NCT05320393|183394660|OTHER|This study was not powered for formal hypothesis testing; analyses were intended for interpretation purposes only. Analysis was performed using the modified Intent-to-Treat population and regardless of responder status.||||||0.0109|TWO_SIDED|95.0|||||Log Rank|||The primary effectiveness endpoint was a measure of duration of effect, described by Kaplan-Meier curves and the median times, with associated 2-sided 95% confidence intervals for each treatment group.||||0.0109
91750842|NCT04411420|183394661|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.169|TWO_SIDED|97.5|-1.55|0.37||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||0.37|-1.55|0.169
91750843|NCT04411420|183394662|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.139|TWO_SIDED|97.5|-0.33|1.52||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||1.52|-0.33|0.139
91750844|NCT04411420|183394663|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.417|TWO_SIDED|95.0|-1.69|0.72||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.||||0.72|-1.69|0.417
91750845|NCT04411420|183394664|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.409|TWO_SIDED|95.0|-1.37|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.57|-1.37|0.409
91506181|NCT04476030|182882846|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7||0.2477|TWO_SIDED|95.0|-2.2|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 15||0.6|-2.2|0.2477
91506182|NCT04476030|182882846|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9248|TWO_SIDED|95.0|-1.6|1.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 42||1.5|-1.6|0.9248
91506183|NCT04476030|182882847|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65||0.4458|TWO_SIDED|95.0|-1.8|0.8|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-1.8|0.4458
91506184|NCT04476030|182882848|SUPERIORITY||Odds Ratio (OR)|1.15||||0.4946|TWO_SIDED|95.0|0.78|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15|Generalized estimating equation is abbreviated as GEE in the method of estimation section.|1.69|0.78|0.4946
91506185|NCT04476030|182882848|SUPERIORITY||Odds Ratio (OR)|0.82||||0.3579|TWO_SIDED|95.0|0.55|1.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.24|0.55|0.3579
91506186|NCT04476030|182882849|SUPERIORITY||Odds Ratio (OR)|1.41||||0.1417|TWO_SIDED|95.0|0.89|2.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||2.24|0.89|0.1417
91506187|NCT04476030|182882849|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7872|TWO_SIDED|95.0|0.62|1.44|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.44|0.62|0.7872
91506188|NCT04476030|182882850|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1993|TWO_SIDED|95.0|-0.4|0.1|||MMRM||Model used was the MMRM with treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.1|-0.4|0.1993
91532290|NCT02400307|182941285|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.02|||||TWO_SIDED|90.0|79.24|123.74||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||123.74|79.24|
91750846|NCT04411420|183394664|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.899|TWO_SIDED|95.0|-1.04|0.91||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-1.04|0.899
91750847|NCT04411420|183394664|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.946|TWO_SIDED|95.0|-1.01|1.08||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||1.08|-1.01|0.946
91506189|NCT04476030|182882851|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0079|TWO_SIDED|95.0|1.21|3.47|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 3||3.47|1.21|0.0079
91506190|NCT04476030|182882851|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6588|TWO_SIDED|95.0|0.74|1.62|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||1.62|0.74|0.6588
91506191|NCT04476030|182882852|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.06||0.2322|TWO_SIDED|95.0|-3.4|0.8|||MMRM||Model used was the MMRM with treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-3.4|0.2322
91506192|NCT04476030|182882853|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5439|TWO_SIDED|95.0|0.76|1.68|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.68|0.76|0.5439
91506193|NCT04476030|182882854|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7054|TWO_SIDED|95.0|0.7|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.69|0.70|0.7054
91506194|NCT04476030|182882855|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.4188|TWO_SIDED|95.0|-1.7|0.7|||MMRM||Model used was the MMRM with treatment, baseline HAM-A total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.7|-1.7|0.4188
91506195|NCT04476030|182882857|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7758|TWO_SIDED|95.0|-1.4|1.0|||MMRM||Model used was the MMRM with treatment, baseline PHQ-9 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||1.0|-1.4|0.7758
91532291|NCT02400307|182941286|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|80.32|||||TWO_SIDED|90.0|59.56|108.3||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.30|59.56|
91750848|NCT04411420|183394665|SUPERIORITY||Odds Ratio, log|-0.004||||0.992|TWO_SIDED|95.0|-4.62|4.61||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Regression, Logistic|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Odds Ratio calculated for Integrated Sequenced Care Pathway relative to Coordinated Care Management Pathway.|||4.61|-4.62|0.992
91506196|NCT02342704|182882861|SUPERIORITY_OR_OTHER|||||||0.126|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 4||||0.1260
91506197|NCT02342704|182882861|SUPERIORITY_OR_OTHER|||||||0.3525|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 4||||0.3525
91506198|NCT02342704|182882861|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 12||||0.0127
91506199|NCT02342704|182882861|SUPERIORITY_OR_OTHER|||||||0.0299|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 12||||0.0299
91506200|NCT02342704|182882861|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 24||||0.0123
91506201|NCT02342704|182882861|SUPERIORITY_OR_OTHER|||||||0.0076|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 24||||0.0076
91506202|NCT02342704|182882862|SUPERIORITY_OR_OTHER|||||||0.5318|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T1 Lesion Volume Change||||0.5318
91750849|NCT04411420|183394666|SUPERIORITY||Median Difference (Final Values)|-2.67||||0.262|TWO_SIDED|95.0|-7.52|2.18||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|||2.18|-7.52|0.262
91506203|NCT02342704|182882862|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T2 Lesion Volume Change||||0.0528
91506204|NCT02342704|182882864|SUPERIORITY_OR_OTHER|||||||0.2632|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||||||0.2632
91750850|NCT04411420|183394667|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.37|TWO_SIDED|97.5|-1.31|0.5||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.50|-1.31|0.37
91506205|NCT01675882|182882923|SUPERIORITY||Relative risk|1.81||||0.0292|TWO_SIDED|95.0|1.05|3.11|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.||3.11|1.05|0.0292
91506206|NCT01675882|182882923|SUPERIORITY||Relative risk|1.64||||0.1074|TWO_SIDED|95.0|0.95|2.85|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05.||2.85|0.95|0.1074
91750851|NCT04411420|183394667|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.24|TWO_SIDED|97.5|-1.54|0.39||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.39|-1.54|0.24
91506207|NCT01675882|182882923|SUPERIORITY||Relative risk|2.0||||0.0108|TWO_SIDED|95.0|1.18|3.38|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05.||3.38|1.18|0.0108
91506208|NCT01675882|182882924|SUPERIORITY||Relative risk|2.95||||0.0035|TWO_SIDED|95.0|1.34|6.49|||Fisher Exact|||||6.49|1.34|0.0035
91506209|NCT01675882|182882924|SUPERIORITY||Relative risk|2.38||||0.0453|TWO_SIDED|95.0|1.04|5.47|||Fisher Exact|||||5.47|1.04|0.0453
91506210|NCT01675882|182882924|SUPERIORITY||Relative risk|2.77||||0.0076|TWO_SIDED|95.0|1.25|6.14|||Fisher Exact|||||6.14|1.25|0.0076
91506211|NCT01675882|182882925|SUPERIORITY||Relative risk|1.5||||0.7112|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.7112
91506212|NCT01675882|182882925|SUPERIORITY||Relative risk|0.47||||0.4048|TWO_SIDED|95.0|0.1|2.28|||Fisher Exact|||||2.28|0.10|0.4048
91506213|NCT01675882|182882925|SUPERIORITY||Relative risk|1.75||||0.4705|TWO_SIDED|95.0|0.62|4.95|||Fisher Exact|||||4.95|0.62|0.4705
91532292|NCT02400307|182941287|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|109.8|||||TWO_SIDED|90.0|87.46|137.85||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||137.85|87.46|
91532293|NCT03248440|182941290|SUPERIORITY|||||||0.579|||||||2-sided Pearson's chi-square|||||||0.579
91750852|NCT04411420|183394667|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.37|TWO_SIDED|97.5|-1.43|0.54|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.54|-1.43|0.37
91750853|NCT04411420|183394668|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.727|TWO_SIDED|97.5|-0.51|0.72||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.72|-0.51|0.727
91506214|NCT01675882|182882926|SUPERIORITY||Relative risk|0.5||||0.5921|TWO_SIDED|95.0|0.13|1.9|||Fisher Exact|||||1.90|0.13|0.5921
91506215|NCT01675882|182882926|SUPERIORITY||Relative risk|1.43||||0.326|TWO_SIDED|95.0|0.71|2.88|||Fisher Exact|||||2.88|0.71|0.3260
91506216|NCT01675882|182882926|SUPERIORITY||Relative risk|1.05||||1|TWO_SIDED|95.0|0.46|2.38|||Fisher Exact|||||2.38|0.46|1.0000
91532294|NCT03248440|182941291|SUPERIORITY|||||||0.082|||||||2-sided Pearson's chi-square|||||||0.082
91750854|NCT04411420|183394668|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.478|TWO_SIDED|97.5|-0.43|0.91||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-0.43|0.478
91750855|NCT04411420|183394668|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.894|TWO_SIDED|97.5|-0.75|0.66||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.66|-0.75|0.894
91750856|NCT04411420|183394669|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.222|TWO_SIDED|95.0|-0.15|0.04||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.04|-0.15|0.222
91750857|NCT04411420|183394669|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.1|0.09||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.09|-0.10|0.988
91750858|NCT04411420|183394669|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.269|TWO_SIDED|95.0|-0.16|0.05||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.05|-0.16|0.269
91532295|NCT04081298|182941317|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.8||0.24|TWO_SIDED|||||The threshold for statistical significance is p=0.05. (feasibility assessment)|Paired sample t-test|||||||0.24
91750859|NCT04411420|183394670|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.477|TWO_SIDED|95.0|-0.22|0.1||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.10|-0.22|0.477
91750860|NCT04411420|183394670|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.877|TWO_SIDED|95.0|-0.19|0.17||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.17|-0.19|0.877
91750861|NCT04411420|183394670|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.36|TWO_SIDED|95.0|-0.29|0.11|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.11|-0.29|0.360
91750862|NCT04411420|183394671|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.23|0.28||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.28|-0.23|0.858
91532296|NCT04081298|182941318|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.78||0.43|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired t-test|||||||0.43
91506217|NCT01675882|182882927|SUPERIORITY||Difference in LS mean|70.2||||0.0607|TWO_SIDED|95.0|-2.41|193.69||P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||193.69|-2.41|0.0607
91506218|NCT01675882|182882927|SUPERIORITY||Difference in LS mean|97.5||||0.015|TWO_SIDED|95.0|14.45|237.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||237.82|14.45|0.0150
91506219|NCT01675882|182882927|SUPERIORITY||Difference in LS mean|242.2|||<|0.0001|TWO_SIDED|95.0|100.03|482.65||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||482.65|100.03|<0.0001
91506220|NCT01675882|182882928|SUPERIORITY||Difference in LS mean|73.9||||0.0372|TWO_SIDED|95.0|2.96|225.85||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||225.85|2.96|0.0372
91532297|NCT04081298|182941319|EQUIVALENCE|McNemar's test evaluates equivalence between nominal groups. Power not calculated as this is a feasibility study with small sample size.||||||0.1|||||||McNemar|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.10
91750863|NCT04411420|183394671|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.688|TWO_SIDED|95.0|-0.32|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.21|-0.32|0.688
91750864|NCT04411420|183394671|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.833|TWO_SIDED|95.0|-0.32|0.26||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.26|-0.32|0.833
91750865|NCT04411420|183394672|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.259|TWO_SIDED|95.0|-0.18|0.64||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.64|-0.18|0.259
91750866|NCT04411420|183394672|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.068|TWO_SIDED|95.0|-0.03|0.81||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.81|-0.03|0.068
91750867|NCT04411420|183394672|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.514|TWO_SIDED|95.0|-0.29|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.57|-0.29|0.514
91532298|NCT04081298|182941320|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.65||0.2|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired-sample t-test|||||||0.20
91750868|NCT04411420|183394673|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.895|TWO_SIDED|95.0|-0.22|0.2||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.20|-0.22|0.895
91750869|NCT04411420|183394673|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.438|TWO_SIDED|95.0|-0.13|0.3||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.30|-0.13|0.438
91750870|NCT04411420|183394673|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.89|TWO_SIDED|95.0|-0.24|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.21|-0.24|0.890
91750871|NCT04411420|183394674|SUPERIORITY||Median Difference (Final Values)|-0.01||||0.508|TWO_SIDED|95.0|-0.04|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.02|-0.04|0.508
91506221|NCT01675882|182882928|SUPERIORITY||Difference in LS mean|96.7||||0.0143|TWO_SIDED|95.0|12.92|278.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||278.11|12.92|0.0143
91506222|NCT01675882|182882928|SUPERIORITY||Difference in LS mean|260.3|||<|0.0001|TWO_SIDED|95.0|89.83|625.95||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||625.95|89.83|<0.0001
91506223|NCT01675882|182882929|SUPERIORITY||Difference in LS mean|26.1||||0.6596|TWO_SIDED|95.0|-59.58|236.0||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||236.00|-59.58|0.6596
91506224|NCT01675882|182882929|SUPERIORITY||Difference in LS mean|8.9||||0.8702|TWO_SIDED|95.0|-65.9|189.96||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||189.96|-65.90|0.8702
91506225|NCT01675882|182882929|SUPERIORITY||Difference in LS mean|158.9||||0.063|TWO_SIDED|95.0|-5.5|562.31||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||562.31|-5.50|0.0630
91506226|NCT01675882|182882930|SUPERIORITY||Difference in LS mean|-80.2||||0.6776|TWO_SIDED|95.0|-237.22|782.24||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||782.24|-237.22|0.6776
91532299|NCT04081298|182941321|EQUIVALENCE|paired sample t-test (feasibility assessment)|Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.73||0.71|TWO_SIDED||||||paired sample t-test|||||||0.71
91532300|NCT04081298|182941322|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.94|||||||paired-sample t-test|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.94
91750872|NCT04411420|183394674|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.03|0.03||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.03|-0.03|0.992
91506227|NCT01675882|182882930|SUPERIORITY||Difference in LS mean|158.8||||0.5068|TWO_SIDED|95.0|-166.1|1478.83||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1478.83|-166.10|0.5068
91532301|NCT04081298|182941323|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.03|||||||paired-sample t-test|||||||0.03
91532302|NCT04081298|182941324|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.36|||||||paired-sample t-test|||||||0.36
91506228|NCT01675882|182882930|SUPERIORITY||Difference in LS mean|53.8||||0.7972|TWO_SIDED|95.0|-193.9|1085.38||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1085.38|-193.90|0.7972
91750873|NCT04411420|183394674|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.389|TWO_SIDED|95.0|-0.05|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.02|-0.05|0.389
91750874|NCT03559699|183394689|OTHER|||||||0.0002|TWO_SIDED|95.0||||1-sided P-value|Binomial exact test|||||||0.0002
91506229|NCT01675882|182882931|SUPERIORITY||Difference in LS mean|120.0||||0.0444|TWO_SIDED|95.0|2.3|321.8||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||321.80|2.30|0.0444
91506230|NCT01675882|182882931|SUPERIORITY||Difference in LS mean|147.6||||0.0175|TWO_SIDED|95.0|19.67|365.51||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||365.51|19.67|0.0175
91506231|NCT01675882|182882931|SUPERIORITY||Difference in LS mean|386.0|||<|0.0001|TWO_SIDED|95.0|159.67|771.16||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||771.16|159.67|<0.0001
91506232|NCT01675882|182882932|SUPERIORITY||Difference in LS mean|-0.6||||0.251|TWO_SIDED|95.0|-1.55|0.52||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||0.52|-1.55|0.2510
91506233|NCT01675882|182882932|SUPERIORITY||Difference in LS mean|-0.2||||0.682|TWO_SIDED|95.0|-1.24|1.05||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.05|-1.24|0.6820
91506234|NCT01675882|182882932|SUPERIORITY||Difference in LS mean|0.8||||0.2117|TWO_SIDED|95.0|-0.42|2.47||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.47|-0.42|0.2117
91506235|NCT01675882|182882934|SUPERIORITY||Difference in LS mean|17.4||||0.0337|TWO_SIDED|95.0|1.17|38.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||38.82|1.17|0.0337
91506236|NCT01675882|182882934|SUPERIORITY||Difference in LS mean|26.2||||0.002|TWO_SIDED|95.0|8.38|49.45||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||49.45|8.38|0.0020
91506237|NCT01675882|182882934|SUPERIORITY||Difference in LS mean|20.0||||0.012|TWO_SIDED|95.0|3.85|40.91||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||40.91|3.85|0.0120
91506238|NCT01675882|182882938|SUPERIORITY||Difference in LS mean|1.2|||<|0.0001|TWO_SIDED|95.0|0.72|1.9||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.90|0.72|<0.0001
91506239|NCT01675882|182882938|SUPERIORITY||Difference in LS mean|1.3|||<|0.0001|TWO_SIDED|95.0|0.79|2.01||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.01|0.79|<0.0001
91532303|NCT02059161|182941325|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.|Difference in the Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.11|0.19|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.19|-0.11|
91532304|NCT02059161|182941326|SUPERIORITY_OR_OTHER||Difference in the Percentages|-3.9|||||TWO_SIDED|95.0|-11.8|4.0|||||Miettinen \& Nurminen|||4.0|-11.8|
91506240|NCT01675882|182882938|SUPERIORITY||Difference in LS mean|2.1|||<|0.0001|TWO_SIDED|95.0|1.39|3.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||3.11|1.39|<0.0001
91506241|NCT01451775|182882950|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|84.04|STANDARD_DEVIATION|6.4|||TWO_SIDED|90.0|80.856|87.344|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||87.344|80.856|
91506242|NCT01451775|182882950|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9367|STANDARD_ERROR_OF_MEAN|0.0178|||TWO_SIDED|95.0|0.8988|0.9746||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||0.9746|0.8988|
91506243|NCT01451775|182882951|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|63.22|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|56.736|70.439|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||70.439|56.736|
91506244|NCT01451775|182882951|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9065|STANDARD_DEVIATION|0.0495|||TWO_SIDED|95.0|0.8011|1.012||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||1.0120|0.8011|
91506245|NCT02016482|182882953|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.001|TWO_SIDED|95.0|32.8|53.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||For US regulatory purposes, ranked first secondary endpoint.||53.6|32.8|< 0.001
91506246|NCT02016482|182882954|SUPERIORITY_OR_OTHER||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|30.8|53.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.||53.2|30.8|< 0.001
91506247|NCT02016482|182882955|SUPERIORITY_OR_OTHER||LS Mean|-44.8|||<|0.001|TWO_SIDED|95.0|-53.5|-36.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.||-36.0|-53.5|< 0.001
91750875|NCT02209948|183394707|OTHER|Log Rank (Mantel-Cox)||||||0.943||||||Threshold P-value of 0.05|Log Rank|||||||0.943
91506248|NCT02016482|182882956|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.008|TWO_SIDED|95.0|1.8|11.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.||11.3|1.8|0.008
91506249|NCT02016482|182882957|SUPERIORITY_OR_OTHER||LS Mean Percent Change|-2.6|||<|0.001|TWO_SIDED|95.0|-3.3|-2.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.||-2.0|-3.3|< 0.001
91506250|NCT02016482|182882958|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.6|-2.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.||-2.2|-3.6|< 0.001
91506251|NCT02016482|182882959|SUPERIORITY_OR_OTHER||Difference in percentage|57.9||||0.002|TWO_SIDED|95.0|33.8|82.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.||82.0|33.8|0.002
91506252|NCT02016482|182882960|SUPERIORITY_OR_OTHER||Difference in percentage|43.3|||<|0.001|TWO_SIDED|95.0|31.3|55.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||55.2|31.3|< 0.001
91532305|NCT02059161|182941327|SUPERIORITY_OR_OTHER||Difference in Percentages|-3.0|||||TWO_SIDED|95.0|-16.1|10.1|||||Miettinen \& Nurminen|||10.1|-16.1|
91750876|NCT02209948|183394708|OTHER||Hazard Ratio (HR)|1.3||||0.16|TWO_SIDED|95.0|0.9|1.88||Threshold of significance P-value 0.05|Regression, Cox|||||1.88|0.90|0.16
91750877|NCT02209948|183394709|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.65|1.5||Threshold for significance P-value 0.05|Regression, Cox|||||1.5|0.65|0.99
91750878|NCT02209948|183394710|OTHER||Hazard Ratio (HR)|1.45||||0.13|TWO_SIDED|95.0|0.89|2.33||threshold for significance 0.05|Regression, Cox|||||2.33|0.89|0.13
91750879|NCT00297102|183394716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.0|STANDARD_ERROR_OF_MEAN|11.0||0.0003|TWO_SIDED|95.0|18.0|60.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||60|18|0.0003
91750880|NCT00297102|183394717|SUPERIORITY_OR_OTHER||Rate ratio|0.851|STANDARD_ERROR_OF_MEAN|0.062||0.0278|TWO_SIDED|95.0|0.737|0.982||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.982|0.737|0.0278
91506253|NCT02016482|182882961|SUPERIORITY_OR_OTHER||Difference in percentage|44.8|||<|0.001|TWO_SIDED|95.0|33.2|56.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||56.5|33.2|< 0.001
91750881|NCT00297102|183394718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|26.0|71.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||71|26|<0.0001
91750882|NCT00297102|183394719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035|STANDARD_ERROR_OF_MEAN|0.357||0.9212|TWO_SIDED|95.0|0.526|2.034||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 765 in the roflumilast group, n= 758 in the placebo group).|||2.034|0.526|0.9212
91750883|NCT00297102|183394720|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|0.9521||||0.4089|TWO_SIDED|95.0|0.8472|1.0699||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.0699|0.8472|0.4089
91750884|NCT00297102|183394721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.111||0.0356|TWO_SIDED|95.0|0.016|0.449||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.449|0.016|0.0356
91750885|NCT03315104|183394739|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.174|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV High Dose (450 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.174
91750886|NCT03315104|183394739|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Mean Difference (Net)|0.0||||0.572|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.572
91750887|NCT03315104|183394739|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons. two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.534
91750888|NCT03315104|183394739|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV pooled (450 mL + 250 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift where the two active dose groups were pooled and compared to placebo.||1.000|0.000|0.534
91750889|NCT05074888|183394758|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.0016
91750890|NCT05074888|183394759|SUPERIORITY|||||||0.3183|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.3183
91750891|NCT05074888|183394760|SUPERIORITY|||||||0.5805|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.5805
91750892|NCT05074888|183394761|SUPERIORITY|||||||0.2143|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.2143
91750893|NCT05074888|183394762|SUPERIORITY|||||||0.8156|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.8156
91750894|NCT05074888|183394763|SUPERIORITY|||||||0.1049|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.1049
91750895|NCT05074888|183394764|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.7260
91750896|NCT05074888|183394765|SUPERIORITY|||||||0.6808|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.6808
91750897|NCT05074888|183394766|SUPERIORITY|||||||0.54||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.54
91750898|NCT05074888|183394767|SUPERIORITY|||||||0.49||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.49
91750899|NCT05074888|183394768|SUPERIORITY|||||||0.87||||||"The p-value associated with treatment\*visit interaction of systolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to SBP/Visit1, SBP/Visit2 and SBP/Visit3 rows.||||0.87
91750900|NCT05074888|183394768|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of diastolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to DBP/Visit1, DBP/Visit2 and DBP/Visit3 rows.||||0.22
91506254|NCT02016482|182882962|SUPERIORITY_OR_OTHER||Difference in percentage|18.6|||<|0.001|TWO_SIDED|95.0|10.6|26.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.6|10.6|< 0.001
91506255|NCT02016482|182882963|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.001|TWO_SIDED|95.0|25.0|46.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||46.9|25.0|< 0.001
91506256|NCT02016482|182882964|SUPERIORITY_OR_OTHER||Difference in percentage|13.3|||<|0.001|TWO_SIDED|95.0|6.5|20.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||20.0|6.5|<0.001
91506257|NCT02016482|182882965|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.8|-4.3|< 0.001
91506258|NCT02016482|182882966|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.9|||<|0.001|TWO_SIDED|95.0|-46.9|-30.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.8|-46.9|< 0.001
91506259|NCT02016482|182882967|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.001|TWO_SIDED|95.0|-33.5|-23.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-23.7|-33.5|< 0.001
91506260|NCT02016482|182882968|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|||<|0.001|TWO_SIDED|95.0|-58.3|-41.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-41.9|-58.3|< 0.001
91506261|NCT02016482|182882969|SUPERIORITY_OR_OTHER||Difference in percentage|7.4||||0.004|TWO_SIDED|95.0|2.4|12.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||12.4|2.4|0.004
91506262|NCT02016482|182882970|SUPERIORITY_OR_OTHER||Difference in percentage|18.5|||<|0.001|TWO_SIDED|95.0|10.1|26.8||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.8|10.1|< 0.001
91506263|NCT02016482|182882971|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|||<|0.001|TWO_SIDED|95.0|-3.1|-1.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-1.9|-3.1|< 0.001
91506264|NCT02016482|182882972|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.2|||<|0.001|TWO_SIDED|95.0|-50.0|-30.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.4|-50.0|< 0.001
91506265|NCT02016482|182882973|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.5|||<|0.001|TWO_SIDED|95.0|-23.6|-15.3||Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.|ANCOVA|||||-15.3|-23.6|< 0.001
91506266|NCT02016482|182882974|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1|||<|0.001|TWO_SIDED|95.0|-10.0|-6.1||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-6.1|-10.0|< 0.001
91506267|NCT02016482|182882975|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.2|||<|0.001|TWO_SIDED|95.0|-87.3|-55.0||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-55.0|-87.3|< 0.001
91506268|NCT02016482|182882976|SUPERIORITY_OR_OTHER||Difference in percentage|51.1|||<|0.001|TWO_SIDED|95.0|38.6|63.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 75||63.5|38.6|< 0.001
91506269|NCT02016482|182882976|SUPERIORITY_OR_OTHER||Difference in percentage|52.5|||<|0.001|TWO_SIDED|95.0|39.9|65.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 50||65.0|39.9|< 0.001
91506270|NCT02016482|182882976|SUPERIORITY_OR_OTHER||Difference in percentage|40.9|||<|0.001|TWO_SIDED|95.0|29.0|52.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 90||52.9|29.0|< 0.001
91506271|NCT02016482|182882976|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.001|TWO_SIDED|95.0|15.8|36.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 100||36.9|15.8|< 0.001
91506272|NCT02016482|182882977|SUPERIORITY_OR_OTHER||Difference in percentage|52.2|||<|0.001|TWO_SIDED|95.0|40.8|63.7||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||63.7|40.8|< 0.001
91506273|NCT02016482|182882978|SUPERIORITY_OR_OTHER||Difference in percentage|24.8|||<|0.001|TWO_SIDED|95.0|15.3|34.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||34.3|15.3|< 0.001
91506274|NCT02016482|182882979|SUPERIORITY_OR_OTHER||Difference in percentage|90.4|||<|0.001|TWO_SIDED|95.0|72.5|108.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||108.3|72.5|< 0.001
91750901|NCT05074888|183394769|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91750902|NCT05074888|183394770|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91750903|NCT05074888|183394771|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
91750904|NCT05074888|183394772|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
91750905|NCT00759356|183394775|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|Mean ratio|109.8||||||90.0|95.3|126.5|||ANOVA|||||126.5|95.3|
91750906|NCT00759356|183394777|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.5||||||90.0|95.6|107.9|||ANOVA|||||107.9|95.6|
91506275|NCT02016482|182882980|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.1|||<|0.001|TWO_SIDED|95.0|-13.9|-8.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-8.4|-13.9|< 0.001
91506276|NCT02016482|182882981|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.6|||<|0.001|TWO_SIDED|95.0|-97.9|-63.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-63.3|-97.9|< 0.001
91506277|NCT02016482|182882982|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.9|||<|0.001|TWO_SIDED|95.0|-64.0|-37.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-37.8|-64.0|< 0.001
91506278|NCT02016482|182882983|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|||<|0.001|TWO_SIDED|95.0|-73.1|-42.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-42.4|-73.1|< 0.001
91506279|NCT02016482|182882984|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.1|-0.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-0.7|-1.1|< 0.001
91750907|NCT00759356|183394778|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|95.9|107.9|||ANOVA|log-transformation||||107.9|95.9|
91750908|NCT03554772|183394818|SUPERIORITY||||||<|0.0001||||||p-value for each dose group vs placebo comparison|ANCOVA|ANCOVA model included treatment as main effect , baseline NPRS and basline BMI as covariates P-value is Dunnett adjusted (individual treatment arms)||||||<0.0001
91750909|NCT04600505|183394819|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|111.7|||||TWO_SIDED|90.0|91.01|137.1||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||137.1|91.01|
91750910|NCT04600505|183394819|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.78|||||TWO_SIDED|90.0|78.67|124.0||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||124.0|78.67|
91750911|NCT04600505|183394819|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|108.3|||||TWO_SIDED|90.0|85.5|137.3||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||137.3|85.50|
91750912|NCT04600505|183394819|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|94.88|||||TWO_SIDED|90.0|74.69|120.5||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||120.5|74.69|
91750913|NCT04600505|183394819|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|109.1|||||TWO_SIDED|90.0|97.02|122.7||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||122.7|97.02|
91750914|NCT04600505|183394819|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|100.1||||||90.0|83.78|119.5||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||119.5|83.78|
91750915|NCT04600505|183394820|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|104.7|||||TWO_SIDED|90.0|91.95|119.2||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||119.2|91.95|
91750916|NCT04600505|183394820|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.03|||||TWO_SIDED|90.0|83.33|115.3||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.3|83.33|
91750917|NCT04600505|183394820|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|96.0||||||90.0|70.33|131.0||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||131.0|70.33|
91750918|NCT04600505|183394820|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|116.7||||||90.0|86.31|157.8||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||157.8|86.31|
91750919|NCT04600505|183394821|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.3|||||TWO_SIDED|90.0|94.53|121.9||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||121.9|94.53|
91750920|NCT04600505|183394821|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.8|||||TWO_SIDED|90.0|84.59|115.4||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.4|84.59|
91750921|NCT04600505|183394821|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|106.1|||||TWO_SIDED|90.0|86.18|130.6||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||130.6|86.18|
91750922|NCT04600505|183394821|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|99.71|||||TWO_SIDED|90.0|80.84|123.0||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||123.0|80.84|
91750923|NCT04600505|183394821|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.13|||||TWO_SIDED|90.0|86.44|111.4||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||111.4|86.44|
91750924|NCT04600505|183394821|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.0|||||TWO_SIDED|90.0|88.82|128.9||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||128.9|88.82|
91750925|NCT00241631|183394827|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
91750926|NCT00241631|183394828|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
91750927|NCT00241631|183394829|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
91750928|NCT00904618|183394831|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||Fisher Exact|||The test applies to the number of participants improved.||||0.0087
91750929|NCT00435162|183394858|SUPERIORITY_OR_OTHER||Slope|-1.05||||0.099|TWO_SIDED|95.0|-2.31|0.2|||Regression, Linear|||Slope change across all 3 active treatment groups.||0.20|-2.31|0.0990
91750930|NCT03373890|183394881|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
91750931|NCT03373890|183394882|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
91750932|NCT03373890|183394883|OTHER|Independent samples Mann Whitney U||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||.03
91750933|NCT03373890|183394884|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
91750934|NCT03373890|183394885|OTHER|Independent samples Mann Whitney U||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
91750935|NCT03373890|183394886|OTHER|Independent samples Mann Whitney U||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||.99
91750936|NCT03373890|183394887|OTHER|LInear mixed model||||||0.008|||||||Regression, Logistic|||||||.008
91750937|NCT03373890|183394888|OTHER|Linear mixed model regression||||||0.34|||||||Regression, Linear|||||||.34
91750938|NCT02680574|183394889|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change of hemoglobin: Vadadustat minus Darbepoetin alfa|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.042|||TWO_SIDED|95.0|-0.09|0.07||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.07|-0.09|
91750939|NCT02680574|183394890|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.2015|TWO_SIDED|95.0|0.93|1.446|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.446|0.930|=0.2015
91750940|NCT02680574|183394890|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
91750941|NCT02680574|183394891|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.09||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.09|-0.10|
91750942|NCT02680574|183394892|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.777|TWO_SIDED|95.0|0.851|1.268|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.268|0.851|=0.7770
91506280|NCT02016482|182882985|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.001|TWO_SIDED|95.0|-33.9|-21.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-21.6|-33.9|< 0.001
91506281|NCT02016482|182882986|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-7.8|-4.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-4.5|-7.8|< 0.001
91506282|NCT02016482|182882987|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.001|TWO_SIDED|95.0|7.1|24.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0||24.3|7.1|< 0.001
91532306|NCT02059161|182941330|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.14|-0.18|
91506283|NCT02016482|182882987|SUPERIORITY_OR_OTHER||Difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|16.7|37.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0/1||37.4|16.7|< 0.001
91506284|NCT02016482|182882988|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.416|TWO_SIDED|95.0|-1.0|2.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Absenteeism||2.5|-1.0|0.416
91750943|NCT02680574|183394892|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
91750944|NCT02680574|183394893|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.5509|TWO_SIDED|95.0|0.817|1.501|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.501|0.817|=0.5509
91750945|NCT02680574|183394893|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
91750946|NCT02680574|183394894|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|0.88|||=|0.4184|TWO_SIDED|95.0|0.61|1.258|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.258|0.610|=0.4184
91750947|NCT02680574|183394894|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
91506285|NCT02016482|182882988|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-22.9|-11.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Presenteeism||-11.6|-22.9|< 0.001
91750948|NCT02680574|183394895|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8041|TWO_SIDED|95.0|0.82|1.315|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.315|0.820|=0.8041
91750949|NCT02680574|183394895|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
91750950|NCT02042534|183394920|SUPERIORITY_OR_OTHER|||||||0.6765|||||||Chi-squared|||||||0.6765
91750951|NCT02042534|183394921|SUPERIORITY_OR_OTHER|||||||0.3753|||||||Chi-squared|||||||0.3753
91750952|NCT02042534|183394922|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||<.0001
91750953|NCT02042534|183394923|SUPERIORITY_OR_OTHER|||||||0.3301|||||||Cochran-Mantel-Haenszel|||||||0.3301
91750954|NCT02133664|183394972|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.57||0.05|TWO_SIDED|95.0|-2.03|4.32|||t-test, 2 sided|||With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.||4.32|-2.03|0.05
91506286|NCT02016482|182882988|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-21.0|-9.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Overall work impairment||-9.3|-21.0|< 0.001
91750955|NCT03906656|183394976|SUPERIORITY||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|8.1||0.0002|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0002
91532307|NCT02059161|182941331|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.77|||||TWO_SIDED|95.0|-4.69|1.16|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.16|-4.69|
91532308|NCT02059161|182941332|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.06|
91750956|NCT03906656|183394976|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|9.7|<|1e-05|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=77). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - Baseline) \<= 0.||||<0.00001
91750957|NCT03906656|183394976|SUPERIORITY||Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.3|<|1e-05|TWO_SIDED||||||t-test, 2 sided||Mean difference is for paired data (n=86). This explains the discrepancy between the mean difference and the difference between the Baseline and KAFO means (n=102 and n=86, respectively).|KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \<= 0.||||<0.00001
91750958|NCT03906656|183394977|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|26.3||0.005|TWO_SIDED|||||P-value not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|63.6 degrees of freedom.||H0: the mean difference (C-Brace - KAFO) \<= 0||||0.005
91750959|NCT03906656|183394978|SUPERIORITY|P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.7||0.005|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|74.4 degrees of freedom||H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.005
91750960|NCT03906656|183394979|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_DEVIATION|53.6||0.583|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1207.5, effect size r = 0.026, p=0.583.|||0.583
91750961|NCT03906656|183394980|SUPERIORITY||Mean Difference (Final Values)|1.28|STANDARD_DEVIATION|4.37||0.0078|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (SAI - Down)|Wilcoxon Signed Rank Test V=438, effect size r = 0.21, p=0.008|||0.0078
91750962|NCT03906656|183394981|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_DEVIATION|17.0||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=267, effect size r = 0.32, p=0.002|||0.0020
91750963|NCT03906656|183394982|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.178||0.0023|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (Fear of falling - indoors)|Wilcoxon Signed Rank Test V=433, effect size r = 0.33, p=0.002|||0.0023
91750964|NCT03906656|183394982|SUPERIORITY||Mean Difference (Final Values)|-0.973|STANDARD_DEVIATION|3.43||0.0066|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=557.5, effect size r = 0.265, p=0.0066|||0.0066
91506287|NCT02016482|182882988|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.4|||<|0.001|TWO_SIDED|95.0|-27.3|-15.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Activity impairment||-15.4|-27.3|< 0.001
91506288|NCT02016482|182882989|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.1|0.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||0.2|0.1|< 0.001
91750965|NCT03906656|183394983|SUPERIORITY|||||||0.006||||||P-value not adjusted for multiple comparisons|McNemar|||Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.||||0.006
91750966|NCT03906656|183394984|SUPERIORITY||Mean Difference (Final Values)|2.82|STANDARD_DEVIATION|16.4||0.08|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1325.5, effect size r = 0.181, p=0.08.|||0.08
91750967|NCT03906656|183394985|SUPERIORITY||Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|0.184||0.151|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||Wilcoxon Signed Rank Test V=1124.5, effect size r = 0.125 p=0.151|H0: the median of the population differences (C-Brace - KAFO) \<= 0||||0.151
91750968|NCT03906656|183394986|SUPERIORITY|H0: the mean of the population differences (C-Brace - KAFO) \>= 0|Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|21.5||0.281|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|16.7 degrees of freedom||WLQ-25 - Physical||||0.281
91506289|NCT02016482|182882990|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5||||0.012|TWO_SIDED|95.0|1.2|9.8||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||9.8|1.2|0.012
91750969|NCT03906656|183394987|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_DEVIATION|5.18||0.00019|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|48.4 degrees of freedom||OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.00019
91750970|NCT03906656|183394988|SUPERIORITY||Mean Difference (Final Values)|3.19|STANDARD_DEVIATION|15.0||0.0226|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|22.1 degrees of freedom||Emotional well-being. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0226
91750971|NCT03906656|183394988|SUPERIORITY||Mean Difference (Final Values)|6.79|STANDARD_DEVIATION|21.1||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|||Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0020
91750972|NCT03906656|183394988|SUPERIORITY||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|29.528||0.0049|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Health change. H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=649, effect size r = 0.285, p=0.00493|||0.0049
91750973|NCT03906656|183394988|SUPERIORITY||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|29.2||6.47e-05|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|37.35 degrees of freedom||Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.0000647
91750974|NCT03906656|183394989|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.843||0.301|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Device. H0: the median of the population differences (C-Brace - KAFO) \<= 0|Wilcoxon Signed Rank Test V=1018.5, effect size r = 0.056, p=0.301|||0.301
91750975|NCT02525939|183395010|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.12|TWO_SIDED|95.0|0.75|1.03||The estimated HR was presented with a 95% CI and a p-value. The primary analysis was conducted at the 0.05 significance level.|Stratified Cox proportional hazard model|||A stratified Cox proportional hazards model was used to analyze the primary endpoint. This model included treatment as a main effect, and region and acute coronary syndrome (ACS) index event type as stratification factors. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 vs HA: λ ≠ 1, where λ is the, assumed constant, hazard ratio (HR) for the time to occurrence of the composite events of the primary endpoint for the dalcetrapib and placebo treated groups.||1.03|0.75|0.12
91750976|NCT02525939|183395011|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.95|TWO_SIDED|95.0|0.88|1.13|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.13|0.88|0.95
91506290|NCT02016482|182882991|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1||||0.025|TWO_SIDED|95.0|-2.0|-0.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS anxiety score||-0.1|-2.0|0.025
91506291|NCT02016482|182882991|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.3|-0.4||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS depression score||-0.4|-2.3|0.005
91750977|NCT02525939|183395012|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.27|TWO_SIDED|95.0|0.79|1.07|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.07|0.79|0.27
91750978|NCT01853072|183395020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.5|3.0|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||3.0|1.5|<0.001
91750979|NCT01853072|183395021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.1|0.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.3|0.1|<0.001
91506292|NCT02016482|182882992|SUPERIORITY_OR_OTHER||Difference in percentage|2.5||||0.164|TWO_SIDED|95.0|-0.9|6.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Chi-squared|||||6|-0.9|0.164
91506293|NCT02016482|182882993|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.4|-2.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.1|-3.4|< 0.001
91506294|NCT03387813|182882994|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1624|TWO_SIDED|95.0|0.74|1.05|||Anderson-Gill model (robust sandwich)|||||1.05|0.74|0.1624
91506295|NCT03387813|182882998|EQUIVALENCE|Clinical equivalence was met if the lower limit of the confidence interval (CI) of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|90.0|0.44|0.6||||||||0.60|0.44|
91532309|NCT02059161|182941333|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|9.6|||||TWO_SIDED|95.0|-3.0|22.2|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||22.2|-3.0|
91532310|NCT02059161|182941334|SUPERIORITY_OR_OTHER||Differences in Percentages|-2.1|||||TWO_SIDED|95.0|-9.8|5.5|||||Miettinen \& Nurminen|||5.5|-9.8|
91506296|NCT03387813|182883002|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0958|TWO_SIDED|95.0|0.7|1.03|||Anderson-Gill model (robust sandwich)|||||1.03|0.70|0.0958
91506297|NCT03387813|182883006|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0644|TWO_SIDED|95.0|0.68|1.01|||Anderson-Gill model (robust sandwich)|||||1.01|0.68|0.0644
91506298|NCT03387813|182883010|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8867|TWO_SIDED|95.0|0.61|1.77|||Anderson-Gill model (robust sandwich)|||||1.77|0.61|0.8867
91506299|NCT03387813|182883014|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7119|TWO_SIDED|95.0|0.7|1.7|||Anderson-Gill model (robust sandwich)|||||1.70|0.70|0.7119
91506300|NCT03387813|182883018|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.44||0.3484|TWO_SIDED|95.0|-4.16|1.47|||t-test, 1 sided|||||1.47|-4.16|0.3484
91506301|NCT03387813|182883018|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|1.47||0.6684|TWO_SIDED|95.0|-3.51|2.26|||t-test, 1 sided|||||2.26|-3.51|0.6684
91506302|NCT03387813|182883020|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.37||0.9901|TWO_SIDED|95.0|-2.68|2.71|||t-test, 1 sided|||||2.71|-2.68|0.9901
91506303|NCT03387813|182883020|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.41||0.2947|TWO_SIDED|95.0|-1.29|4.24|||t-test, 1 sided|||||4.24|-1.29|0.2947
91506304|NCT03387813|182883022|SUPERIORITY||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|7.36||0.5741|TWO_SIDED|95.0|-10.32|18.6|||t-test, 1 sided|||||18.60|-10.32|0.5741
91506305|NCT03387813|182883022|SUPERIORITY||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|7.81||0.7077|TWO_SIDED|95.0|-12.41|18.27|||t-test, 1 sided|||||18.27|-12.41|0.7077
91506306|NCT03387813|182883025|EQUIVALENCE|Clinical equivalence was met if the lower limit of the CI of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.38|0.55||||||||0.55|0.38|
91506307|NCT03387813|182883029|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91506308|NCT03387813|182883033|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91506309|NCT03387813|182883037|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
91532311|NCT02059161|182941335|SUPERIORITY_OR_OTHER||Difference in Percentages|0.8|||||TWO_SIDED|95.0|-12.8|14.3|||||Miettinen \& Nurminen|||14.3|-12.8|
91750980|NCT01287221|183395026|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.82
91506310|NCT03387813|182883043|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.39|0.54|||Anderson-Gill model (robust sandwich)|||||0.54|0.39|<0.0001
91506311|NCT03387813|182883044|OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.53|0.76|||Anderson-Gill model (robust sandwich)|||||0.76|0.53|<0.001
91506312|NCT03387813|182883049|SUPERIORITY||Least Square Means Difference (T vs C)|1.53|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|0.29|2.78|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 6 months between Treatment vs Control group||2.78|0.29|0.0160
91506313|NCT03387813|182883049|SUPERIORITY||Least Square Means Difference (T vs C)|0.79|STANDARD_ERROR_OF_MEAN|0.39||0.0427|TWO_SIDED|95.0|0.03|1.56|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 6 months between Treatment vs Control group.||1.56|0.03|0.0427
91506314|NCT03387813|182883049|SUPERIORITY||Least Square Means Difference (T vs C)|1.13|STANDARD_ERROR_OF_MEAN|0.48||0.0188|TWO_SIDED|95.0|0.19|2.08|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 6 months between Treatment vs Control group.||2.08|0.19|0.0188
91506315|NCT03387813|182883049|SUPERIORITY||Least Square Means Difference (T vs C)|0.63|STANDARD_ERROR_OF_MEAN|0.66||0.3405|TWO_SIDED|95.0|-0.66|1.92|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 12 months between Treatment vs Control group.||1.92|-0.66|0.3405
91506316|NCT03387813|182883049|SUPERIORITY||Least Square Means Difference (T vs C)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6174|TWO_SIDED|95.0|-0.59|0.99|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 12 months between Treatment vs Control group.||0.99|-0.59|0.6174
91506317|NCT03387813|182883049|SUPERIORITY||Least Square Means Difference (T vs C)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4231|TWO_SIDED|95.0|-0.58|1.38|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 12 months between Treatment vs Control group.||1.38|-0.58|0.4231
91506318|NCT03387813|182883050|SUPERIORITY|||||||0.0214|||||||t-test, 2 sided|||Comparison of PA Systolic Pressure AUC between Treatment and Control group.||||0.0214
91506319|NCT03387813|182883050|OTHER|||||||0.1002|||||||t-test, 2 sided|||Comparison of PA Diastolic Pressure AUC between Treatment and Control group.||||0.1002
91506320|NCT03387813|182883050|OTHER|||||||0.0402|||||||t-test, 2 sided|||Comparison of PA Mean Pressure AUC between Treatment and Control group.||||0.0402
91506321|NCT03387813|182883051|SUPERIORITY||Least Square Means Difference (T vs C)|37.19|STANDARD_ERROR_OF_MEAN|75.52||0.6227|TWO_SIDED|95.0|-111.38|185.77|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 6 months between Treatment vs Control group||185.77|-111.38|0.6227
91506322|NCT03387813|182883052|SUPERIORITY||Least Square Means Difference (T vs C)|59.78|STANDARD_ERROR_OF_MEAN|76.87||0.4373|TWO_SIDED|95.0|-91.44|211.01|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 12 months between Treatment vs Control group||211.01|-91.44|0.4373
91506323|NCT03387813|182883053|SUPERIORITY||Least Square Means Difference (T vs C)|468.1|STANDARD_ERROR_OF_MEAN|256.65||0.0692|TWO_SIDED|95.0|-37.09|973.3|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 6months between Treatment vs Control group||973.30|-37.09|0.0692
91506324|NCT03387813|182883054|SUPERIORITY||Least Square Means Difference (T vs C)|284.67|STANDARD_ERROR_OF_MEAN|268.72||0.2903|TWO_SIDED|95.0|-244.27|813.6|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 12 months between Treatment vs Control group||813.60|-244.27|0.2903
91506325|NCT03387813|182883055|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.78|||Anderson-Gill model (robust sandwich)|||||0.78|0.53|<0.0001
91506326|NCT03387813|182883056|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.81|||Anderson-Gill model (robust sandwich)|||||0.81|0.57|<0.0001
91750981|NCT01287221|183395027|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.62
91506327|NCT00606892|182883072|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.||||<0.05
91506328|NCT00606892|182883073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|40.0|<|0.3|TWO_SIDED|95.0|||||ANOVA|F(1,10)=1.1||||||<0.3
91506329|NCT00606892|182883074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0||||Values of p\<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p\<0.016.|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.||||<0.05
91506330|NCT00606892|182883075|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P\<0.016|ANOVA|Two-tailed tests were applied for main effects with P\<0.05||A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.||||<0.05
91506331|NCT04681482|182883132|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.54|0.7|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of MB between cohorts.||0.70|0.54|<0.001
91506332|NCT04681482|182883134|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.088|TWO_SIDED|95.0|0.66|1.03|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of stroke/SE between cohorts.||1.03|0.66|0.088
91506333|NCT04681482|182883136|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of net clinical benefit between cohorts.||0.76|0.60|<0.001
91506334|NCT00896337|182883145|SUPERIORITY_OR_OTHER||9-month major adverse event rate|3.4|||<|0.0001|TWO_SIDED|95.0|0.9|8.5||A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.|One-sided exact-test|||MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of \<=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.||8.5|0.9|<0.0001
91506335|NCT02531321|182883212|OTHER|Unpaired t test with Welch's correction|||||<|0.05|||||||t-test, 2 sided|||||||<.05
91506336|NCT01113879|182883216|OTHER||||||<|0.001|TWO_SIDED|85.0|||||Weighted Tau U|||Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).||||< 0.001
91532312|NCT02059161|182941337|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||||TWO_SIDED|95.0|-4.92|1.39|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.39|-4.92|
91532313|NCT02059161|182941338|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.02|||||TWO_SIDED|95.0|-0.05|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.05|
91506337|NCT00082433|182883251|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0005||95.0|0.69|0.9|||Log Rank|||The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.||.90|.69|.0005
91506338|NCT00082433|182883252|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89|||<|0.0001||95.0|1.44|2.5|||Cochran-Mantel-Haenszel|||||2.50|1.44|<.0001
91506339|NCT00082433|182883256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||<0.0001
91506340|NCT00082433|182883257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1162||95.0|0.78|1.03||The test was stratified by (taxane resistance \[yes/no\], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease \[yes/no\], and anthracycline resistance \[yes/no\]).|Log Rank|The analysis was conducted at the 0.05 level and no adjustments were performed||This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.||1.03|.78|.1162
91506341|NCT00082433|182883257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0231||95.0|0.75|0.98|||Regression, Cox|||This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.||.98|.75|.0231
91506342|NCT01796197|182883260|SUPERIORITY||Pathelogic Complete Response Rate|40.0|||||TWO_SIDED||||||Two stage design, exact method||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 15% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 40% then the regimen is worthy of further study.|Null Hypothesis: pCR rate is less than or equal to 15% Alternative Hypothesis: pCR rate is greater than or equal to 40% Hypothesized False Positive Rate (alpha) : 3.9% Hypothesized False Negative Rate (1-beta) : 9.9%||||
91506343|NCT00244712|182883293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 \[ABC/3TC minus TDF/FTC\] was -12% or greater.|difference in response percentage|0.39||||0.913||95.0|-6.63|7.4|||Cochran-Mantel-Haenszel||Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2|||7.40|-6.63|0.913
91506344|NCT02818218|182883326|SUPERIORITY||correlation coefficient|0.0005||||0.944|TWO_SIDED|98.3|-0.161|0.17|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.170|-0.161|0.944
91506345|NCT02818218|182883327|SUPERIORITY||correlation coefficient|0.27|||<|0.001|TWO_SIDED|98.3|0.11|0.42|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.42|0.11|<0.001
91506346|NCT02818218|182883328|SUPERIORITY||correlation coefficient|0.34|||<|0.001|TWO_SIDED|98.3|0.19|0.48|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.48|0.19|<0.001
91506347|NCT02818218|182883330|SUPERIORITY||correlation coefficient|0.07||||0.298|TWO_SIDED|98.3|-0.1|0.24|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.24|-0.10|0.298
91506348|NCT02818218|182883331|SUPERIORITY||correlation coefficient|0.22||||0.002|TWO_SIDED|98.3|0.05|0.37|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.37|0.05|0.002
91532314|NCT02059161|182941339|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.4|||||TWO_SIDED|95.0|-19.7|8.9|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.9|-19.7|
91532315|NCT02059161|182941341|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.4|||||TWO_SIDED|95.0|-8.9|8.2|||||Longitudinal data analysis model including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.2|-8.9|
91750982|NCT01287221|183395028|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.23
91750983|NCT01287221|183395029|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.31
91532316|NCT02059161|182941342|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-8.1|||||TWO_SIDED|95.0|-18.6|2.4|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||2.4|-18.6|
91532317|NCT02059161|182941343|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C < 7.0%)|-0.8|||||TWO_SIDED|95.0|-9.7|8.1|||||Miettinen and Nurminen, stratified by prior insulin status.|||8.1|-9.7|
91532318|NCT02059161|182941343|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C <6.5%)|-1.1|||||TWO_SIDED|95.0|-8.6|6.5|||||Miettinen and Nurminen, stratified by prior insulin status.|||6.5|-8.6|
91532319|NCT02059161|182941344|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 7.0%)|0.2|||||TWO_SIDED|95.0|-8.7|9.1|||||Miettinen and Nurminen|||9.1|-8.7|
91750984|NCT01287221|183395030|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.65
91506349|NCT02818218|182883332|SUPERIORITY||correlation coefficient|0.33|||<|0.001|TWO_SIDED|98.3|0.17|0.47|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.47|0.17|<0.001
91506350|NCT02970968|182883343|SUPERIORITY|||||||0.0099|||||||Mixed Models Analysis|||||||.0099
91506351|NCT02970968|182883344|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||||||.0160
91506352|NCT02970968|182883345|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|||||||.039
91506353|NCT02970968|182883346|SUPERIORITY|||||||0.0223|||||||Mixed Models Analysis|||||||.0223
91506354|NCT02970968|182883347|SUPERIORITY|||||||0.0497|||||||Mixed Models Analysis|||||||.0497
91506355|NCT02970968|182883348|SUPERIORITY|||||||0.0207|||||||Mixed Models Analysis|||||||.0207
91506356|NCT02970968|182883349|SUPERIORITY|||||||0.0429|||||||Mixed Models Analysis|||||||.0429
91506357|NCT02970968|182883350|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91506358|NCT02970968|182883351|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||.0003
91506359|NCT02970968|182883352|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
91506360|NCT02970968|182883353|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|||||||.0078
91506361|NCT02970968|182883354|SUPERIORITY|||||||0.0294|||||||Mixed Models Analysis|||||||.0294
91506362|NCT02970968|182883355|SUPERIORITY|||||||0.0229|||||||Mixed Models Analysis|||||||.0229
91750985|NCT01287221|183395031|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.61
91506363|NCT02970968|182883356|SUPERIORITY|||||||0.0018|||||||Mixed Models Analysis|||||||.0018
91506364|NCT02970968|182883357|SUPERIORITY|||||||0.0013|||||||Mixed Models Analysis|||||||.0013
91506365|NCT02970968|182883358|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||.0001
91506366|NCT02970968|182883359|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||.018
91506367|NCT02970968|182883360|SUPERIORITY|||||||0.0164|||||||Mixed Models Analysis|||||||.0164
91506368|NCT02970968|182883361|SUPERIORITY|||||||0.0053|||||||Mixed Models Analysis|||||||.0053
91506369|NCT02970968|182883362|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.0020
91506370|NCT03003520|182883365|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
91506371|NCT03003520|182883365|SUPERIORITY||AUC-ROC|0.477||||0.872|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their CD8 density.||||0.872
91506372|NCT03003520|182883366|SUPERIORITY|||||||0.0403||||||Significance defined as 0.05.|Fisher Exact|||||||0.0403
91506373|NCT03003520|182883366|SUPERIORITY||AUC-ROC|0.583||||0.523|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of total cells.||||0.523
91506374|NCT03003520|182883367|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
91506375|NCT03003520|182883367|SUPERIORITY||AUC-ROC|0.583||||0.557|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of tumor cells.||||0.557
91750986|NCT01287221|183395032|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.22
91506376|NCT03003520|182883368|SUPERIORITY|||||||0.662||||||Significance defined as 0.05.|Fisher Exact|||||||0.662
91506377|NCT03003520|182883368|SUPERIORITY||AUC-ROC|0.6||||0.399|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their IFNG-Score.||||0.399
91506378|NCT01332149|182883371|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.148||0.0559|TWO_SIDED|95.0|-0.58|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.01|-0.58|0.0559
91506379|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0527|TWO_SIDED|95.0|-0.47|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.47|0.0527
91506380|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.121||0.0279|TWO_SIDED|95.0|-0.5|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.50|0.0279
91506381|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.121||0.0508|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.48|0.0508
91506382|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.121||0.0349|TWO_SIDED|95.0|-0.49|-0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.02|-0.49|0.0349
91506383|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.122||0.0672|TWO_SIDED|95.0|-0.46|0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.46|0.0672
91506384|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.122||0.0469|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.00|-0.48|0.0469
91506385|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.028|TWO_SIDED|95.0|-0.51|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.51|0.0280
91750987|NCT04030247|183395055|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
91750988|NCT04030247|183395056|OTHER|||||||0.16|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.16
91750989|NCT04030247|183395057|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
91750990|NCT04030247|183395058|OTHER|||||||0.9|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.9
91506386|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.122||0.014|TWO_SIDED|95.0|-0.54|-0.06||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.06|-0.54|0.0140
91506387|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.122||0.0375|TWO_SIDED|95.0|-0.49|-0.01||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.01|-0.49|0.0375
91506388|NCT01332149|182883372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.105||0.0164|TWO_SIDED|95.0|-0.46|-0.05||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis||Overall change was estimated from the mixed effect model treatment main effect.|Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.46|0.0164
91506389|NCT01332149|182883374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.143||0.134|TWO_SIDED|95.0|-0.49|0.07||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.07|-0.49|0.1340
91506390|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.3438|TWO_SIDED|95.0|-0.37|0.13||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.13|-0.37|0.3438
91506391|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.128||0.2482|TWO_SIDED|95.0|-0.4|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.40|0.2482
91750991|NCT04030247|183395059|OTHER|||||||0.5|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.5
91750992|NCT04030247|183395060|OTHER|||||||0.4|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.4
91750993|NCT04030247|183395062|OTHER|||||||0.6|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.6
91506392|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2249|TWO_SIDED|95.0|-0.41|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.41|0.2249
91506393|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1094|TWO_SIDED|95.0|-0.46|0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.05|-0.46|0.1094
91506394|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2095|TWO_SIDED|95.0|-0.41|0.09||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.09|-0.41|0.2095
91506395|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.129||0.0531|TWO_SIDED|95.0|-0.5|0.0||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.50|0.0531
91532320|NCT02059161|182941344|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 6.5%)|-4.4|||||TWO_SIDED|95.0|-11.5|2.8|||||Miettinen and Nurminen|||2.8|-11.5|
91750994|NCT03809910|183395069|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.09|<.0001
91750995|NCT03809910|183395070|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.17|-0.07||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.07|-0.17|<0.0001
91750996|NCT03809910|183395071|SUPERIORITY||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.16|-0.06||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.06|-0.16|<0.0001
91750997|NCT03809910|183395072|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.25|-0.19||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.19|-0.25|<0.0001
91506396|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1628|TWO_SIDED|95.0|-0.44|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.44|0.1628
91532321|NCT02059161|182941345|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|-0.42|||||TWO_SIDED|95.0|-2.33|1.48|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.48|-2.33|
91750998|NCT03809910|183395073|SUPERIORITY||Adjusted Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.43|-0.33||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.33|-0.43|<0.0001
91750999|NCT03809910|183395074|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.39|-0.29||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.29|-0.39|<0.0001
91751000|NCT03809910|183395075|SUPERIORITY||Adjusted Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.13|0.18||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.18|0.13|<0.0001
91751001|NCT03809910|183395076|SUPERIORITY||Adjusted Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.21|0.31||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.31|0.21|<0.0001
91751002|NCT03809910|183395077|SUPERIORITY||Adjusted Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.18|0.28||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.28|0.18|<0.0001
91751003|NCT03809910|183395078|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.15||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.15|0.09|<0.0001
91751004|NCT03809910|183395078|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.0214|TWO_SIDED|95.0|-0.06|0.0||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.00|-0.06|0.0214
91751005|NCT03809910|183395079|SUPERIORITY||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.13|0.23||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.23|0.13|<0.0001
91751006|NCT03809910|183395079|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|-0.14|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.14|0.0010
91751007|NCT03809910|183395080|SUPERIORITY||Adjusted Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.15|0.25||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.25|0.15|<0.0001
91751008|NCT03809910|183395080|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.026||0.1652|TWO_SIDED|95.0|-0.09|0.01||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.01|-0.09|0.1652
91751009|NCT03880838|183395092|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.391
91751010|NCT03880838|183395092|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.861|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.861
91751011|NCT03880838|183395092|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.01||0.835|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.835
91751012|NCT03880838|183395092|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.877|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.877
91751013|NCT03880838|183395092|SUPERIORITY||Slope|0.004|STANDARD_ERROR_OF_MEAN|0.01||0.969|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.969
91751014|NCT03880838|183395092|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.893
91751015|NCT03880838|183395092|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.689|TWO_SIDED||||||Regression, Linear|||In this contrast, In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.689
91506397|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|95.0|-0.48|0.02||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.48|0.0770
91532322|NCT02059161|182941346|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|0.0|||||TWO_SIDED|95.0|-0.02|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.02|
91751016|NCT03880838|183395092|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.427|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.427
91751017|NCT03880838|183395092|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.504|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.504
91751018|NCT03880838|183395092|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.893
91751019|NCT03880838|183395092|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.918|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.918
91751020|NCT03880838|183395092|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.755|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.755
91751021|NCT03880838|183395092|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.858|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.858
91751022|NCT03880838|183395093|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46||0.436|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.436
91751023|NCT03880838|183395093|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.45||0.539|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.539
91751024|NCT03880838|183395093|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.66||0.994|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.994
91751025|NCT03880838|183395093|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.66||0.7|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.700
91751026|NCT03880838|183395093|SUPERIORITY||Slope|0.75|STANDARD_ERROR_OF_MEAN|0.66||0.258|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.258
91751027|NCT03880838|183395093|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.428|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.428
91751028|NCT03880838|183395093|SUPERIORITY||Slope|-0.48|STANDARD_ERROR_OF_MEAN|0.62||0.434|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.434
91751029|NCT03880838|183395093|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.62||0.228|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.228
91751030|NCT03880838|183395093|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.674|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.674
91751031|NCT03880838|183395093|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.61||0.799|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.799
91751032|NCT03880838|183395093|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.61||0.794|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.794
91751033|NCT03880838|183395093|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.871|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.871
91751034|NCT03880838|183395093|SUPERIORITY||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.62||0.139|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.139
91751035|NCT03880838|183395094|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.357|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.357
91751036|NCT03880838|183395094|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.28||0.294|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.294
91506398|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1651|TWO_SIDED|95.0|-0.43|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.43|0.1651
91506399|NCT01332149|182883375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.1006|TWO_SIDED|95.0|-0.4|0.04||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.04|-0.40|0.1006
91506400|NCT01332149|182883376|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.1309|TWO_SIDED|95.0|0.93|1.74||Analysis was two-sided and performed at the 0.05 significance level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||1.74|0.93|0.1309
91751037|NCT03880838|183395094|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.4||0.496|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.496
91751038|NCT03880838|183395094|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.4||0.722|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.722
91751039|NCT03880838|183395094|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.445|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.445
91751040|NCT03880838|183395094|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.38||0.531|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.531
91751041|NCT03880838|183395094|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.177|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.177
91751042|NCT03880838|183395094|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.38||0.314|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.314
91751043|NCT03880838|183395094|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.38||0.85|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.850
91751044|NCT03880838|183395094|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.37||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.391
91751045|NCT03880838|183395094|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.37||0.906|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.906
91751046|NCT03880838|183395094|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.37||0.635|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.635
91751047|NCT03880838|183395094|SUPERIORITY||Slope|0.63|STANDARD_ERROR_OF_MEAN|0.37||0.093|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||0.093
91751048|NCT02080260|183395175|SUPERIORITY||16-week PFS Rate|0.1||||0.824|TWO_SIDED|95.0|0.012|0.317||This p-value is only based on partial enrollment of the study. The study enrollment was stopped early due to futility.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|The null hypothesis assumes a median PFS of 6 weeks, corresponding to a 16-week PFS rate of approximately 0.15. A single-stage design will be used to test that the 16-week PFS rate is less than or equal to 0.15. If at least 8 of the 32 subjects are alive and progression free at 16 weeks, the null hypothesis will be rejected. Assuming a one-sided alpha = 0.10 significance level, this will provide at least 90% power to reject the null hypothesis, assuming the true 16-week PFS rate is 0.35.||0.317|0.012|0.824
91751049|NCT02080260|183395176|OTHER|Estimation only.|Median|6.1|||||TWO_SIDED|95.0|2.9|7.1|||||The Kaplan Meier method was used to estimate the median PFS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||7.1|2.9|
91751050|NCT02080260|183395177|OTHER|Estimation only.|Median|9.4|||||TWO_SIDED|95.0|8.1|17.0|||||The Kaplan Meier method was used to estimate the median OS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||17.0|8.1|
91751051|NCT02080260|183395178|OTHER|Estimation only|Overall Response Rate|0.05|||||TWO_SIDED|95.0|0.001|0.249|||||Confidence interval estimated using the Clopper Pearson method.|||0.249|0.001|
91751052|NCT02080260|183395179|OTHER|Estimation only.|Disease Control Rate|0.3|||||TWO_SIDED|95.0|0.119|0.543|||||Confidence interval estimated using the Clopper Pearson method.|||0.543|0.119|
91751053|NCT02091284|183395199|OTHER||||||<|0.01||||||Two-way ANOVA with repeated measures followed by Bonferroni's multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group.|ANOVA|||||||< 0.01
91751054|NCT02091284|183395199|OTHER||||||<|0.05|||||||t-test, 2 sided|||Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests.||||<0.05
91751055|NCT02853435|183395206|OTHER||Ratio of geometric LS means|1.0417|||||TWO_SIDED|90.0|0.9809|1.1063|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1063|0.9809|
91751056|NCT02853435|183395206|OTHER||Ratio of geometric LS means|1.1108|||||TWO_SIDED|90.0|1.0459|1.1797|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1797|1.0459|
91506401|NCT01332149|182883379|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.25|STANDARD_ERROR_OF_MEAN|1.628||0.0463|TWO_SIDED|95.0|-6.45|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||-0.05|-6.45|0.0463
91506402|NCT01332149|182883380|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.061||0.2748|TWO_SIDED|95.0|-0.19|0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.05|-0.19|0.2748
91751057|NCT02853435|183395207|OTHER||Ratio of geometric LS means|1.0408|||||TWO_SIDED|90.0|0.9792|1.1062|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1062|0.9792|
91751058|NCT02853435|183395207|OTHER||Ratio of geometric LS means|1.1138|||||TWO_SIDED|90.0|1.0479|1.1838|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1838|1.0479|
91751059|NCT02853435|183395209|OTHER||Ratio of geometric LS means|0.9586|||||TWO_SIDED|90.0|0.844|1.0888|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.0888|0.8440|
91751060|NCT02853435|183395209|OTHER||Ratio of geometric LS means|1.1487|||||TWO_SIDED|90.0|1.0113|1.3047|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.3047|1.0113|
91751061|NCT02853435|183395210|OTHER||Median Difference (Final Values)|-0.233||||0.309|TWO_SIDED|90.0|-0.267|0.0||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||0.000|-0.267|0.309
91751062|NCT02853435|183395210|OTHER||Median Difference (Final Values)|-0.492|||<|0.001|TWO_SIDED|90.0|-0.5|-0.25||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||-0.250|-0.500|<0.001
91751063|NCT02583230|183395376|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in PHQ-9 total scores over the eight-week study period.||||||.0005
91751064|NCT02583230|183395377|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in QIDS total scores over the eight-week study period.||||||.0008
91751065|NCT02317809|183395384|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|114.45|||||TWO_SIDED|90.0|110.87|118.15|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||118.15|110.87|
91751066|NCT02317809|183395385|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|106.99|||||TWO_SIDED|90.0|101.42|112.86|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||112.86|101.42|
91751067|NCT02317809|183395386|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|112.67|||||TWO_SIDED|90.0|106.44|119.27|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||119.27|106.44|
91751068|NCT02317809|183395387|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|103.27|||||TWO_SIDED|90.0|93.16|114.47|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||114.47|93.16|
91751069|NCT03054350|183395501|SUPERIORITY||Least squares mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.314||0.0004|TWO_SIDED|95.0|0.56|1.82|||ANCOVA|The analysis of covariance (ANCOVA) model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.82|0.56|0.0004
91751070|NCT03054350|183395501|SUPERIORITY||Least squares mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.315|<|0.0001|TWO_SIDED|95.0|0.93|2.19|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.19|0.93|<0.0001
91751071|NCT03054350|183395501|SUPERIORITY||Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|1.23|2.54|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.54|1.23|<0.0001
91751072|NCT03054350|183395507|SUPERIORITY||Least squares mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.122||0.0232|TWO_SIDED|95.0|0.04|0.54|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups;1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.54|0.04|0.0232
91751073|NCT03054350|183395507|SUPERIORITY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.121||0.0033|TWO_SIDED|95.0|0.13|0.62|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.62|0.13|0.0033
91751074|NCT03054350|183395507|SUPERIORITY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.12||0.0002|TWO_SIDED|95.0|0.26|0.74|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.74|0.26|0.0002
91751075|NCT03054350|183395507|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.3289|TWO_SIDED|94.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.3289
91506403|NCT01332149|182883382|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.577||0.4758|TWO_SIDED|95.0|-4.22|1.97||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.97|-4.22|0.4758
91506404|NCT01332149|182883383|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.31|STANDARD_ERROR_OF_MEAN|2.22||0.1363|TWO_SIDED|95.0|-1.05|7.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||7.67|-1.05|0.1363
91506405|NCT01332149|182883384|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.371||0.8808|TWO_SIDED|95.0|-2.49|2.9||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.90|-2.49|0.8808
91506406|NCT01332149|182883385|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0887|TWO_SIDED|95.0|-0.03|0.4||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.40|-0.03|0.0887
91506407|NCT01332149|182883386|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.7929|TWO_SIDED|95.0|0.72|1.53||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||1.53|0.72|0.7929
91506408|NCT01332149|182883387|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.973||0.596|TWO_SIDED|95.0|-2.83|4.92||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||4.92|-2.83|0.5960
91506409|NCT01332149|182883388|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|1.536||0.8216|TWO_SIDED|95.0|-3.36|2.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.67|-3.36|0.8216
91506410|NCT01332149|182883389|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.177||0.4829|TWO_SIDED|95.0|-3.14|1.49||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.49|-3.14|0.4829
91506411|NCT01332149|182883390|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.073||0.0431|TWO_SIDED|95.0|-0.29|0.0||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||-0.00|-0.29|0.0431
91751076|NCT03054350|183395507|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.007||0.2607|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.2607
91751077|NCT03054350|183395507|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.0252|TWO_SIDED|95.0|0.0|0.03|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.03|0.00|0.0252
91506412|NCT01332149|182883391|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0602|TWO_SIDED|95.0|-0.28|0.01||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||0.01|-0.28|0.0602
91506413|NCT01332149|182883393|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.207||0.4172|TWO_SIDED|95.0|-0.57|0.24||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.24|-0.57|0.4172
91506414|NCT01332149|182883394|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3724|TWO_SIDED|95.0|-0.62|0.23||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.23|-0.62|0.3724
91506415|NCT00071812|182883453|SUPERIORITY_OR_OTHER||percent difference from placebo|18.8||||0.0097|TWO_SIDED|95.0|4.8|32.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||32.8|4.8|0.0097
91506416|NCT00071812|182883453|SUPERIORITY_OR_OTHER||percent difference from placebo|9.4||||0.1677|TWO_SIDED|95.0|-3.9|22.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||22.7|-3.9|0.1677
91506417|NCT00071812|182883453|SUPERIORITY_OR_OTHER||percent difference from placebo|12.2||||0.0796|TWO_SIDED|95.0|-1.3|25.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||25.8|-1.3|0.0796
91532323|NCT02059161|182941347|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.5|||||TWO_SIDED|95.0|-3.69|0.69|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.69|-3.69|
91532324|NCT02059161|182941348|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02||||||95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
91751078|NCT03054350|183395509|SUPERIORITY||Least squares mean difference|3.31|STANDARD_ERROR_OF_MEAN|1.303||0.0154|TWO_SIDED|95.0|0.67|5.94|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.94|0.67|0.0154
91751079|NCT03054350|183395509|SUPERIORITY||Least squares mean difference|4.61|STANDARD_ERROR_OF_MEAN|1.261||0.0008|TWO_SIDED|95.0|2.06|7.16|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.16|2.06|0.0008
91506418|NCT00071812|182883454|SUPERIORITY_OR_OTHER||percent difference from placebo|5.4||||0.2074|TWO_SIDED|95.0|-3.0|13.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||13.7|-3.0|0.2074
91506419|NCT00071812|182883454|SUPERIORITY_OR_OTHER||percent difference from placebo|4.1||||0.3177|TWO_SIDED|95.0|-4.0|12.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||12.2|-4.0|0.3177
91506420|NCT00071812|182883454|SUPERIORITY_OR_OTHER||percent difference from placebo|9.7||||0.0418|TWO_SIDED|95.0|0.3|19.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||19.2|0.3|0.0418
91506421|NCT00071812|182883455|SUPERIORITY_OR_OTHER||percent difference from placebo|2.7||||0.4299|TWO_SIDED|95.0|-4.0|9.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||9.3|-4.0|0.4299
91506422|NCT00071812|182883455|SUPERIORITY_OR_OTHER||percent difference from placebo|-1.5||||0.5393|TWO_SIDED|95.0|-6.3|3.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||3.3|-6.3|0.5393
91532325|NCT02059161|182941349|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.74|||||TWO_SIDED|95.0|-2.52|1.04|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.04|-2.52|
91751080|NCT03054350|183395509|SUPERIORITY||Least squares mean difference|5.93|STANDARD_ERROR_OF_MEAN|1.296|<|0.0001|TWO_SIDED|95.0|3.31|8.56|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||8.56|3.31|<0.0001
91751081|NCT03054350|183395509|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.273||0.3572|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.81|-0.30|0.3572
91751082|NCT03054350|183395509|SUPERIORITY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.252||0.4758|TWO_SIDED|95.0|-0.33|0.69|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.69|-0.33|0.4758
91751083|NCT03054350|183395509|SUPERIORITY||Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.254||0.2048|TWO_SIDED|95.0|-0.19|0.84|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.84|-0.19|0.2048
91751084|NCT03054350|183395511|SUPERIORITY|||||||0.9373|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9373
91751085|NCT03054350|183395511|SUPERIORITY|||||||0.6623|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.6623
91751086|NCT03054350|183395511|SUPERIORITY|||||||0.9374|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9374
91751087|NCT03054350|183395511|SUPERIORITY|||||||0.2085|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.2085
91751088|NCT03054350|183395511|SUPERIORITY|||||||0.0016|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0016
91751089|NCT03054350|183395511|SUPERIORITY|||||||0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0001
91751090|NCT03054350|183395513|SUPERIORITY|||||||0.2708|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.2708
91751091|NCT03054350|183395513|SUPERIORITY|||||||0.0966|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0966
91751092|NCT03054350|183395513|SUPERIORITY|||||||0.0424|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0424
91751093|NCT03054350|183395515|SUPERIORITY|||||||0.0207|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0207
91751094|NCT03054350|183395515|SUPERIORITY|||||||0.0022|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0022
91751095|NCT03054350|183395515|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
91751096|NCT03054350|183395515|SUPERIORITY|||||||0.0062|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0062
91751097|NCT03054350|183395515|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0002
91751098|NCT03054350|183395515|SUPERIORITY||||||<|0.0001||||||test of treatment group difference based on ANCOVA model|ANCOVA|||Hepcidin||||<0.0001
91751099|NCT01643850|183395547|SUPERIORITY||Mean Difference (Net)|0.98||||0.915|TWO_SIDED|95.0|0.71|1.36|||ANCOVA|||||1.36|0.71|0.915
91751100|NCT01643850|183395547|SUPERIORITY||Median Difference (Net)|0.78||||0.117|TWO_SIDED|95.0|0.57|1.07|||ANCOVA|||||1.07|0.57|0.117
91751101|NCT01643850|183395547|SUPERIORITY||Mean Difference (Net)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91|||ANCOVA|||||0.91|0.52|0.010
91751102|NCT02419131|183395633|SUPERIORITY|Superiority of the experimental arms (CBTH and CPT) compared to usual care (TAU)|Aggregated contrast CBTH to TAU|-3.4|||<|0.001|TWO_SIDED|95.0|-5.4|-1.4||p-value represents an aggregate of post-treatment outcomes (i.e., post-treatment, 3-month, and 6-month outcomes entered simultaneously into the GLMM to represent a single metric of all post-treatment assessment intervals into one estimate).|Mixed Models Analysis|Outcome observations at posttreatment, 3-month and 6-month follow-ups were entered simultaneously into the mixed model to provide a single inference.|Contrast of aggregated post-treatment outcomes of HIT-6 total score for CBTH compared to TAU|Sample size based on 2-tailed specified joint superiority testing of 2 primary outcomes at α = .025 and power of 0.80 to detect an effect size (d) of 0.52 for both primary outcomes (representing a clinically significant change of 2.8 points on the HIT-6). The primary analysis set was intention to treat (ITT). multiple imputation accounted for missing data in ITT. Missing outcome scores at posttreatment, 3-month, and 6-month follow-ups were multiply imputed (m = 100) using multilevel models.||-1.4|-5.4|<0.001
91751103|NCT02419131|183395633|SUPERIORITY|See previous section for analysis|Aggregated contrast CPT to TAU|-1.4||||0.21|TWO_SIDED|95.0|-3.7|0.8||For comparison of post-treatment HIT-6 total score between CPT and TAU|Mixed Models Analysis|See above for details.|See above.|See previous section for power||0.8|-3.7|0.21
91751104|NCT02419131|183395634|SUPERIORITY|Key parameters and details the same as HIT-6 described above.|Aggregated contrast CBTH to TAU|-6.5||||0.04|TWO_SIDED|95.0|-12.7|-0.3||Contrast of aggregate post-treatment outcomes between CBTH and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CBTH and TAU||Same sample size calculation as HIT-6 analyses, powered to detect a difference of 8.2 points on the PCL-5 total score.||-0.3|-12.7|0.04
91751105|NCT02419131|183395634|SUPERIORITY|Contrast of aggregate post-treatment outcomes between CPT and TAU|Aggregated contrast CPT to TAU|-8.9||||0.01|TWO_SIDED|95.0|-15.9|-1.9||Contrast of aggregate post-treatment outcomes between CPT and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CPT and TAU||See above.||-1.9|-15.9|0.01
91751106|NCT00681564|183395654|SUPERIORITY_OR_OTHER|||||||0.98||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics.||||0.98
91751107|NCT00681564|183395654|SUPERIORITY_OR_OTHER|||||||0.005||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours).||||0.005
91751108|NCT00681564|183395654|SUPERIORITY_OR_OTHER|||||||0.43||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||"Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures.~Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org."||||0.43
91751109|NCT02370641|183395666|OTHER||Mean Difference (Final Values)|-4.0||||0.012|TWO_SIDED|||||p\<0.05 is defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Firmicutes abundance between urolithin excretors and non excretors||||0.012
91751110|NCT02370641|183395666|OTHER||Mean Difference (Final Values)|2.6||||0.009|TWO_SIDED|||||p\<0.05 was defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Proteobacteria abundance between urolithin excretors and non excretors||||0.009
91751111|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.10|-0.56|0.0056
91751112|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.48|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.48|-0.95|<0.0001
91751113|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.98|-0.51|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.51|-0.98|<0.0001
91751114|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted mean|-0.57|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.81|-0.34|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.34|-0.81|<0.0001
91751115|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment||-0.09|-0.56|0.0062
91751116|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.49|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.49|-0.95|<0.0001
91751117|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.56|-1.03|<0.0001
91751118|NCT01719003|183395669|SUPERIORITY_OR_OTHER||Adjusted mean|-0.63|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.86|-0.4|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.40|-0.86|<0.0001
91751119|NCT01719003|183395669|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.39|STANDARD_ERROR_OF_MEAN|0.12||0.6246|TWO_SIDED|95.0|0.15|0.62|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 25 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.62|0.15|0.6246
91751120|NCT01719003|183395669|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.4|STANDARD_ERROR_OF_MEAN|0.12||0.6558|TWO_SIDED|95.0|0.16|0.63|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 10 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.63|0.16|0.6558
91506423|NCT00071812|182883455|SUPERIORITY_OR_OTHER||percent difference from placebo|-0.1||||0.9769|TWO_SIDED|95.0|-5.6|5.4||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||5.4|-5.6|0.9769
91506424|NCT00071812|182883456|SUPERIORITY_OR_OTHER|||||||0.1752||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.1752
91506425|NCT00071812|182883456|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.3440
91506426|NCT00071812|182883456|SUPERIORITY_OR_OTHER|||||||0.4308||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.4308
91506427|NCT00071812|182883459|SUPERIORITY_OR_OTHER|||||||0.0958||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using last observation carried forward (LOCF) imputation.||||0.0958
91506428|NCT00071812|182883459|SUPERIORITY_OR_OTHER|||||||0.7864||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.7864
91506429|NCT00071812|182883459|SUPERIORITY_OR_OTHER|||||||0.0051||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.0051
91506430|NCT00071812|182883460|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0960
91506431|NCT00071812|182883460|SUPERIORITY_OR_OTHER|||||||0.2859||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.2859
91506432|NCT00071812|182883460|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0109
91751121|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted mean|-18.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-25.5|-12.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-12.2|-25.5|<0.0001
91506433|NCT00071812|182883461|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.1940
91506434|NCT00071812|182883461|SUPERIORITY_OR_OTHER|||||||0.2561||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.2561
91506435|NCT00071812|182883461|SUPERIORITY_OR_OTHER|||||||0.8707||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.8707
91506436|NCT03711162|182883619|SUPERIORITY||Least square (LS) mean difference|22.7|STANDARD_ERROR_OF_MEAN|38.12||0.5525|TWO_SIDED|95.0|-52.3|97.6||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.||||97.6|-52.3|0.5525
91751122|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted mean|-23.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-29.7|-16.3||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-16.3|-29.7|<0.0001
91751123|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted Mean|-26.7|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-33.5|-20.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-20.0|-33.5|<0.0001
91751124|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted mean|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.8|-9.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-9.2|-22.8|<0.0001
91751125|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted mean|-15.6|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.3|-8.9||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment||-8.9|-22.3|<0.0001
91751126|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted Mean|-14.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-21.4|-8.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-8.2|-21.4|<0.0001
91751127|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted Mean|-28.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-35.0|-21.5||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-21.5|-35.0|<0.0001
91751128|NCT01719003|183395670|SUPERIORITY_OR_OTHER||Adjusted mean|-12.6|STANDARD_ERROR_OF_MEAN|3.4||0.0002|TWO_SIDED|95.0|-19.1|-6.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-6.0|-19.1|0.0002
91751129|NCT01719003|183395671|SUPERIORITY_OR_OTHER||Adjusted mean|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.33|-1.68||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.68|-3.33|<0.0001
91751130|NCT01719003|183395671|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.52|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.35|-1.69||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.69|-3.35|<0.0001
91751131|NCT01719003|183395671|SUPERIORITY_OR_OTHER||Adjusted mean|-2.2|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.03|-1.37||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment||-1.37|-3.03|<0.0001
91751132|NCT01719003|183395671|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.26|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.09|-1.43||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.43|-3.09|<0.0001
91751133|NCT02370095|183395672|SUPERIORITY|||||||0.2416|||||||Wilcoxon (Mann-Whitney)|||Only one placebo subject had data to allow for change from baseline to be calculated||||0.2416
91751134|NCT02370095|183395673|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|The change in S/F ratio over time was evaluated using a mixed model for repeated measures||||||0.06
91751135|NCT02370095|183395674|SUPERIORITY|||||||0.0679|||||||Wilcoxon (Mann-Whitney)|||||||0.0679
91751136|NCT02370095|183395679|SUPERIORITY|||||||0.567|||||||Mixed Models Analysis|Measurement of MAP were evaluated from baseline to end of treatment||||||0.567
91751137|NCT02370095|183395680|SUPERIORITY|||||||0.2507||||||The threshold for statistical significance was 0.05|Fisher Exact|||||||0.2507
91751138|NCT02370095|183395682|SUPERIORITY|||||||0.5055|||||||Fisher Exact|||||||0.5055
91751139|NCT00700102|183395685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0062|TWO_SIDED|95.0|0.69|0.94|||Log Rank|||||0.94|0.69|0.0062
91751140|NCT00700102|183395686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1713|TWO_SIDED|95.0|0.77|1.05|||Log Rank|||Kaplan Meier Estimate||1.05|0.77|0.1713
91751141|NCT00700102|183395688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.59|0.78|||Log Rank|||||0.78|0.59|<.0001
91751142|NCT00700102|183395689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.3113|TWO_SIDED|95.0|-1.5|4.5|||Chi-squared|||||4.5|-1.5|0.3113
91751143|NCT00700102|183395689|SUPERIORITY_OR_OTHER|||||||0.4315|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4315
91751144|NCT02130986|183395697|SUPERIORITY||Mean Difference (Net)|-0.05||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
91751145|NCT02130986|183395698|NON_INFERIORITY|Procalcitonin algorithm implementation increases or does not change the proportion of subjects who experience a composite endpoint of adverse outcomes by Day 30. The prespecified noninferiority margin is 4.5 percentage.|Risk Difference (RD)|-0.015|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91751146|NCT02130986|183395699|SUPERIORITY||Risk Difference (RD)|-4.6|||||TWO_SIDED|95.0|-12.2|30.0||||||||30|-12.2|
91751147|NCT00762996|183395714|NON_INFERIORITY_OR_EQUIVALENCE|"margin +/- 0.5 logMar lines~The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark.~logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal."|Mean Difference (Final Values)|0.005287|STANDARD_ERROR_OF_MEAN|0.00976||||95.0|-0.01389|0.2447|||Mixed Models Analysis||logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.|Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.||0.2447|-0.01389|
91751148|NCT00762996|183395715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4757|STANDARD_ERROR_OF_MEAN|0.2505||||95.0|0.05563|0.4757|||Mixed Models Analysis||Mean difference is etafilcon A minus omafilcon A.|||0.4757|0.05563|
91751149|NCT00657150|183395719|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%|Risk Difference (Percentage)|-1.08|||<|0.0001||95.0|-3.79|1.64||Superiority p-value = 0.4367|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.64|-3.79|< 0.0001
91751150|NCT00657150|183395720|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.91||||0.029||95.0|-3.64|-0.19|||Normal approximation|Normal approximation of independent binomial distribution without stratification||||-0.19|-3.64|0.029
91751151|NCT00657150|183395721|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.79||||0.0358||95.0|-3.47|-0.12|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||-0.12|-3.47|0.0358
91751152|NCT00657150|183395722|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.96||||0.4839|TWO_SIDED|95.0|-3.65|1.73|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.73|-3.65|0.4839
91751153|NCT00657150|183395723|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0612
91751154|NCT00657150|183395724|SUPERIORITY_OR_OTHER|||||||0.6231||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6231
91751155|NCT00657150|183395725|SUPERIORITY_OR_OTHER|||||||0.4977||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4977
91751156|NCT00657150|183395726|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6870
91751157|NCT00657150|183395727|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||Fisher Exact|||Comparison versus Enoxaparin for the category major bleeding events||||0.4022
91751158|NCT00657150|183395727|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.8||||0.3305|TWO_SIDED|95.0|-0.8|2.3|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events||2.3|-0.8|0.3305
91751159|NCT00657150|183395727|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.4||||0.2626|TWO_SIDED|95.0|-1.1|3.9|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category any bleeding events||3.9|-1.1|0.2626
91751160|NCT02649192|183395732|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season||||0.90
91751161|NCT02649192|183395732|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season||||0.49
91751162|NCT02649192|183395732|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season||||0.50
91751163|NCT02649192|183395732|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season||||0.90
91751164|NCT02649192|183395732|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season||||0.76
91751165|NCT02649192|183395732|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season||||0.65
91751166|NCT02649192|183395732|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season||||0.90
91751167|NCT02649192|183395732|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season||||0.76
91751168|NCT02649192|183395732|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season||||0.54
91751169|NCT02649192|183395732|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season||||0.90
91751170|NCT02649192|183395732|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season||||0.95
91751171|NCT02649192|183395732|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season||||0.34
91751172|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|H1N1||0|0|
91751173|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-23.6|||||TWO_SIDED|95.0|-51.7|6.2|||||Treatment group minus placebo|H1N1||6.2|-51.7|
91751174|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-13.0|||||TWO_SIDED|95.0|-49.4|26.5|||||Treatment group minus placebo|H1N1||26.5|-49.4|
91751175|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-10.0|||||TWO_SIDED|95.0|-70.1|56.1|||||Treatment group minus placebo|H3N2||56.1|-70.1|
91751176|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-8.6|||||TWO_SIDED|95.0|-38.8|20.6|||||Treatment group minus placebo|H3N2||20.6|-38.8|
91751177|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|22.7|||||TWO_SIDED|95.0|-17.5|57.9|||||Treatment group minus placebo|H3N2||57.9|-17.5|
91751178|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Phuket||0|0|
91751179|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Phuket||5.8|-54.1|
91751180|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|16.9|||||TWO_SIDED|95.0|-23.1|53.3|||||Treatment group minus placebo|B/Phuket||53.3|-23.1|
91751181|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Brisbane||0|0|
91532326|NCT02059161|182941350|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.01|||||TWO_SIDED|95.0|-0.03|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.03|
91751182|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Brisbane||5.8|-54.1|
91751183|NCT02649192|183395733|SUPERIORITY||Treatment Difference in Seroconversion R|-8.4|||||TWO_SIDED|95.0|-45.4|30.5|||||Treatment group minus placebo|B/Brisbane||30.5|-45.4|
91751184|NCT03849690|183395737|OTHER|Analysis of variance (ANOVA) performed on natural log(ln)-transformed TAK-906 Cmax which exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as random effect. Each ANOVA included calculation of least-squares means(LSM) and difference between treatment LSM. Geometric mean ratios and 90% confidence interval (CI) were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.87||||0.3011|TWO_SIDED|90.0|0.7|1.09|||ANOVA|||||1.09|0.70|0.3011
91751185|NCT03849690|183395738|OTHER|ANOVA was performed on ln-transformed TAK-906 AUClast which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90 percent (%) CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.0865|TWO_SIDED|90.0|0.77|0.99|||ANOVA|||||0.99|0.77|0.0865
91751186|NCT03849690|183395739|OTHER|ANOVA was performed on ln-transformed TAK-906 AUC∞ which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90% CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.3011|TWO_SIDED|90.0|0.78|1.0|||ANOVA|||||1.00|0.78|0.3011
91751187|NCT01319721|183395744|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91751188|NCT01319721|183395745|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91751189|NCT01319721|183395746|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
91751190|NCT01319721|183395747|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91751191|NCT01319721|183395748|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91751192|NCT00468845|183395754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.1378
91751193|NCT00468845|183395754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.4710
91751194|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.7752
91751195|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.3375
91506437|NCT03711162|182883619|SUPERIORITY||LS mean difference|-26.7|STANDARD_ERROR_OF_MEAN|37.53||0.4776|TWO_SIDED|95.0|-100.5|47.1||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||47.1|-100.5|0.4776
91506438|NCT03711162|182883620|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9648|TWO_SIDED|95.0|0.56|1.74|||Regression, Logistic|||||1.74|0.56|0.9648
91506439|NCT03711162|182883620|SUPERIORITY||Odds Ratio (OR)|1.05||||0.853|TWO_SIDED|95.0|0.6|1.84|||Regression, Logistic|||||1.84|0.60|0.8530
91751196|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7029||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.7029
91751197|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8618||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.8618
91751198|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2117||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2117
91751199|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6255
91751200|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0942
91751201|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9907||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.9907
91751202|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4678||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4678
91751203|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5500
91751204|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9333||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.9333
91751205|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7396||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7396
91751206|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2932||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.2932
91751207|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0164||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0164
91751208|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2468||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.2468
91751209|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7022
91506440|NCT03711162|182883621|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.05|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||2.05|0.50|
91751210|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7257||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7257
91751211|NCT00468845|183395755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3854||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3854
91751212|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5997
91751213|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8582||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8582
91751214|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3704||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.3704
91751215|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9747||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.9747
91751216|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2033
91751217|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2752
91751218|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0183
91751219|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6906||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.6906
91751220|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5446||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5446
91751221|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4852||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4852
91506441|NCT03711162|182883621|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.47|1.88|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||1.88|0.47|
91506442|NCT03711162|182883622|SUPERIORITY||LS mean difference|-0.5||||0.785|TWO_SIDED|95.0|-4.4|3.3|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||3.3|-4.4|0.7850
91751222|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5879||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.5879
91751223|NCT00468845|183395756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7699||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7699
91506443|NCT03711162|182883622|SUPERIORITY||LS mean difference|0.3||||0.8617|TWO_SIDED|95.0|-3.4|4.1|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||4.1|-3.4|0.8617
91751224|NCT00468845|183395757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9676||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.9676
91751225|NCT00468845|183395757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4944||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4944
91751226|NCT00468845|183395758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4801||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4801
91506444|NCT03711162|182883623|SUPERIORITY||LS Mean difference|19.4|STANDARD_ERROR_OF_MEAN|33.68|||TWO_SIDED|95.0|-46.9|85.7|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||85.7|-46.9|
91506445|NCT03711162|182883623|SUPERIORITY||LS Mean difference|-29.1|STANDARD_ERROR_OF_MEAN|32.95|||TWO_SIDED|95.0|-93.9|35.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||35.8|-93.9|
91506446|NCT03711162|182883624|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.68|1.95|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.95|0.68|
91506447|NCT03711162|182883624|SUPERIORITY||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.74|2.09|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||2.09|0.74|
91506448|NCT03711162|182883625|SUPERIORITY||LS mean difference|3.7|||||TWO_SIDED|95.0|-11.5|19.0|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||19.0|-11.5|
91751227|NCT00468845|183395758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8832||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.8832
91751228|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2125||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hours PS||||0.2125
91751229|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hour PS||||0.7602
91751230|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4053||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4053
91751231|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4147||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4147
91751232|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5556||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.5556
91751233|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.4820
91751234|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.5088
91506449|NCT03711162|182883625|SUPERIORITY||LS mean difference|2.9|||||TWO_SIDED|95.0|-11.1|16.8|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||16.8|-11.1|
91506450|NCT03711162|182883626|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.65|1.78|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.78|0.65|
91532327|NCT02059161|182941351|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.25|||||TWO_SIDED|95.0|-3.34|0.83|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.83|-3.34|
91532328|NCT02059161|182941352|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
91751235|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.3900
91751236|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9659||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.9659
91751237|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.3968
91751238|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8308||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.8308
91751239|NCT00468845|183395759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0902||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.0902
91751240|NCT00468845|183395760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4388||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4388
91751241|NCT00468845|183395760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.3364
91751242|NCT00468845|183395761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2409||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.2409
91506451|NCT03711162|182883626|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.76|1.98|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.98|0.76|
91751243|NCT00468845|183395761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1654||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.1654
91751244|NCT00468845|183395761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1110
91751245|NCT00468845|183395761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0598||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0598
91751246|NCT00468845|183395761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0398
91506452|NCT03711162|182883629|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.44|3.81|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.81|0.44|
91506453|NCT03711162|182883629|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.42|3.5|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.50|0.42|
91506454|NCT03711162|182883630|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.08|0.66|
91532329|NCT03389893|182941353|SUPERIORITY||Geometric Mean Ratio|0.033|||<|0.001|TWO_SIDED|95.0|0.008|0.131|||ANCOVA||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator.|||0.131|0.008|<0.001
91751247|NCT00468845|183395761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0623||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0623
91751248|NCT00468845|183395762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.2730
91751249|NCT00468845|183395762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.1015
91751250|NCT00468845|183395762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2438||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.2438
91751251|NCT00468845|183395762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.0102
91751252|NCT00468845|183395762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2063||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.2063
91751253|NCT00468845|183395762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.0387
91751254|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5995||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5995
91506455|NCT03711162|182883630|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||2.61|0.36|
91751255|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.9104
91751256|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.2177
91751257|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1770
91751258|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1229||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1229
91751259|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1274||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1274
91751260|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0568
91751261|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0354
91751262|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4269||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.4269
91751263|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2058
91751264|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8215
91751265|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5331||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.5331
91751266|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7365||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7365
91751267|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9989||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.9989
91751268|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2501
91751269|NCT00468845|183395763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.6021
91751270|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6613||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.6613
91751271|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1311||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.1311
91751272|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6574
91751273|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6949||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6949
91751274|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.2008
91751275|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.3022
91751276|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6382||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.6382
91751277|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.8624
91751278|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3858||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.3858
91751279|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4814||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4814
91751280|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.9520
91751281|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2315||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.2315
91751282|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7061||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.7061
91751283|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2908||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.2908
91751284|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4782||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4782
91751285|NCT00468845|183395764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.813||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.8130
91751286|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.894||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8940
91751287|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5938
91506456|NCT03711162|182883631|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.08|0.66|
91506457|NCT03711162|182883631|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||2.61|0.36|
91506458|NCT03711162|182883632|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.91|0.59|
91751288|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4306||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.4306
91751289|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5899||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.5899
91751290|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2209||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2209
91751291|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.7145
91751292|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.1022
91751293|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.7243
91751294|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2310
91751295|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9192||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.9192
91751296|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.3214
91506459|NCT03711162|182883632|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.46|0.43|
91751297|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8641||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8641
91506460|NCT03711162|182883633|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.91|0.59|
91751298|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3024||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.3024
91751299|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7359||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7359
91751300|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.4303
91751301|NCT00468845|183395765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2133
91506461|NCT03711162|182883633|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.46|0.43|
91751302|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.5682
91751303|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1005||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.1005
91751304|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8261||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.8261
91751305|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9981||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.9981
91751306|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8884||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8884
91751307|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4507||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.4507
91751308|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.2994
91751309|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4371||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.4371
91751310|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8295
91751311|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8783||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8783
91751312|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2161||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.2161
91751313|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0440
91751314|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3855||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.3855
91751315|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.2010
91751316|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.7104
91751317|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6107||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.6107
91751318|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6705
91751319|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2083||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2083
91751320|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.3234
91751321|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.5938
91751322|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9711||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.9711
91751323|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.4869
91751324|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7439||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.7439
91751325|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.8045
91751326|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5925||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.5925
91751327|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.6830
91751328|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8266||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.8266
91751329|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.1929
91751330|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.7071
91751331|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.9367
91751332|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6046||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.6046
91506462|NCT02431754|182883654|SUPERIORITY_OR_OTHER|||||||0.0937|||||||Normal approximation (Z-test)|||||||0.0937
91506463|NCT02431754|182883655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.1485|TWO_SIDED|95.0|-1.69|0.26|||Mixed Models Analysis|||||0.26|-1.69|0.1485
91751333|NCT00468845|183395766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5119||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.5119
91751334|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6966||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.6966
91751335|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.1808
91751336|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2616||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2616
91751337|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1014||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.1014
91751338|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4401
91751339|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5615
91751340|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7615
91751341|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.6204
91751342|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8766||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.8766
91751343|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1717||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1717
91751344|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4065||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4065
91751345|NCT00468845|183395767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0746
91751346|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2201
91751347|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.0606
91751348|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5303
91751349|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2227||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.2227
91751350|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8237||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8237
91751351|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7476||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7476
91751352|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6882||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.6882
91751353|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.9689
91751354|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5010
91751355|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9143||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.9143
91751356|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7381||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.7381
91751357|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5336||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.5336
91751358|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6479||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.6479
91751359|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.1133
91751360|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7637||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.7637
91751361|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1056||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1056
91751362|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8079||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.8079
91751363|NCT00468845|183395768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0917
91751364|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7511||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7511
91751365|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6742||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6742
91751366|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.3808
91751367|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7021
91751368|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0045
91751369|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7916||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7916
91751370|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3682
91751371|NCT00468845|183395769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1419||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1419
91751372|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.3323
91751373|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5662||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.5662
91751374|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9538||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.9538
91751375|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4592||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4592
91751376|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.4793
91751377|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8517||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8517
91751378|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1829||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1829
91751379|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3544||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.3544
91751380|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.1718
91751381|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5078
91751382|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2443||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.2443
91751383|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8296||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.8296
91751384|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3243
91751385|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3755||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3755
91751386|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9584||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.9584
91751387|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1187
91751388|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7915||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.7915
91751389|NCT00468845|183395770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0703
91751390|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1975||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.1975
91751391|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2784||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.2784
91751392|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0271
91751393|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0881||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0881
91751394|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0159||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0159
91751395|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.1870
91751396|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1752
91751397|NCT00468845|183395771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6923||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6923
91751398|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6295
91751399|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6890
91751400|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5094||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.5094
91751401|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8741||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.8741
91751402|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0214
91751403|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9366||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.9366
91506464|NCT01275066|182883661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|9.35||0.0174||95.0||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.0174
91506465|NCT01275066|182883661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|9.29||0.9542||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.9542
91751404|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7833||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7833
91751405|NCT00468845|183395774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2983||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.2983
91751406|NCT00468845|183395777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6861||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.6861
91751407|NCT00468845|183395777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.9905
91751408|NCT00468845|183395778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4264||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.4264
91751409|NCT00468845|183395778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3045||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.3045
91751410|NCT00468845|183395779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0714||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.0714
91751411|NCT00468845|183395779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4455||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.4455
91751412|NCT00468845|183395780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7418||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.7418
91751413|NCT00468845|183395780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5154||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.5154
91751414|NCT00468845|183395781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6715||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.6715
91751415|NCT00468845|183395781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9013||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.9013
91751416|NCT00468845|183395782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9126||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||0.9126
91751417|NCT00468845|183395782|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||1.0000
91506466|NCT01275066|182883662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.66||0.4935||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.4935
91751418|NCT00468845|183395783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1233||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1233
91751419|NCT00468845|183395783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1666||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1666
91751420|NCT00468845|183395784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0361||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0361
91751421|NCT00468845|183395784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0797||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0797
91751422|NCT00468845|183395785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0206
91751423|NCT00468845|183395785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0011
91751424|NCT00468845|183395787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3506||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours||||0.3506
91751425|NCT00468845|183395788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.0287
91751426|NCT00468845|183395788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.2270
91751427|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1872||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.1872
91751428|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.3994
91751429|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0422||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.0422
91751430|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3647||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.3647
91751431|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1729||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.1729
91751432|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.2234
91751433|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.0950
91751434|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4345||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.4345
91751435|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.2840
91751436|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6404||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.6404
91506467|NCT01275066|182883662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.66||0.7783||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.7783
91506468|NCT01275066|182883663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
91532330|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.28||||0.019|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||0.80|0.09|0.019
91751437|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.0550
91506469|NCT01275066|182883663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|4.19|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
91532331|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||1.51|0.09|0.165
91532332|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.02|0.27|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||0.27|0.02|<0.001
91532333|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.25|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||0.25|0.02|<0.001
91751438|NCT00468845|183395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4531||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.4531
91751439|NCT00468845|183395790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9712||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.9712
91751440|NCT00468845|183395790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0112
91751441|NCT00468845|183395790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0090
91751442|NCT00468845|183395790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.8650
91751443|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8914||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.8914
91751444|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.2214
91532334|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.16||||0.004|TWO_SIDED|95.0|0.05|0.55|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||0.55|0.05|0.004
91532335|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.38||||0.216|TWO_SIDED|95.0|0.08|1.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||1.80|0.08|0.216
91751445|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.1008
91751446|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9135||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.9135
91751447|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.5609
91751448|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.4047
91751449|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1663||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.1663
91751450|NCT00468845|183395791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.8364
91751451|NCT00468845|183395792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7218||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7218
91751452|NCT00468845|183395792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4425||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.4425
91751453|NCT00468845|183395793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7889||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7889
91751454|NCT00468845|183395793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1565||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.1565
91751455|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6211||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.6211
91751456|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3687||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.3687
91751457|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.7078
91751458|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8696||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.8696
91751459|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.4320
91751460|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8843||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.8843
91751461|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.6215
91751462|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2722||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.2722
91751463|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.5500
91751464|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.9942
91751465|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.0075
91751466|NCT00468845|183395794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1464||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.1464
91751467|NCT00468845|183395795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9877||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.9877
91751468|NCT00468845|183395795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1334||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.1334
91751469|NCT00468845|183395795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3566||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.3566
91751470|NCT00468845|183395795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6262||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.6262
91751471|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.9463
91751472|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7347||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.7347
91751473|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4132||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4132
91751474|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4929
91751475|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6003||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.6003
91506470|NCT03240133|182883664|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-6.98||||0.0024|TWO_SIDED|95.0|-11.37|-2.6|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 750mg berotralstat or placebo.||-2.6|-11.37|0.0024
91506471|NCT03240133|182883664|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-2.1||||0.6424|TWO_SIDED|95.0|-11.49|7.29|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 500mg berotralstat or placebo.||7.29|-11.49|0.6424
91506472|NCT03240133|182883664|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|0.57||||0.8283|TWO_SIDED|95.0|-4.9|6.03|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 250mg berotralstat or placebo.||6.03|-4.9|0.8283
91751476|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.9343
91751477|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3838||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.3838
91751478|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.1351
91751479|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.3343
91751480|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7948||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.7948
91751481|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.8090
91751482|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4035||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.4035
91751483|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6009
91506473|NCT03240133|182883665|SUPERIORITY||Odds Ratio (OR)|0.196||||0.0029|TWO_SIDED|95.0|0.069|0.559|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 750 mg-treated-attack requiring SOC-Rx was 0.196 that of a placebo attack.||0.559|0.069|0.0029
91506474|NCT03240133|182883665|SUPERIORITY||Odds Ratio (OR)|0.472||||0.4048|TWO_SIDED|95.0|0.074|2.988|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 500 mg-treated-attack requiring SOC-Rx was 0.472 that of a placebo attack.||2.988|0.074|0.4048
91532336|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.24||||0.071|TWO_SIDED|95.0|0.05|1.13|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||1.13|0.05|0.071
91506475|NCT03240133|182883665|SUPERIORITY||Odds Ratio (OR)|0.587||||0.5984|TWO_SIDED|95.0|0.073|4.733|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 250 mg-treated-attack requiring SOC-Rx was 0.587 that of a placebo attack.||4.733|0.073|0.5984
91506476|NCT00116831|182883674|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma volume|-4.58||||||95.0||||||||||||
91506477|NCT00116831|182883675|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen volume|0.32||||||95.0||||||||||||
91506478|NCT00116831|182883676|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel volume|-3.56||||||95.0||||||||||||
91532337|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.34||||0.022|TWO_SIDED|95.0|0.13|0.85|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.85|0.13|0.022
91532338|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.76|0.08|0.015
91532339|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.04|0.41|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.41|0.04|<0.001
91751484|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7597||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7597
91751485|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7804||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7804
91751486|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0463
91751487|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.4951
91506479|NCT00116831|182883678|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma area|-0.13||||||95.0||||||||||||
91506480|NCT00116831|182883679|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen area|0.02||||||95.0||||||||||||
91751488|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.3030
91506481|NCT00116831|182883680|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel area|-0.11||||||95.0||||||||||||
91506482|NCT00116831|182883683|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.64||||0.1221||95.0|-1.457|0.173|||ANCOVA|||||0.173|-1.457|0.1221
91506483|NCT00116831|182883684|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-5.12||||||95.0||||||||||||
91506484|NCT00116831|182883686|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-1.72||||||95.0||||||||||||
91506485|NCT00116831|182883688|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.11||||||95.0||||||||||||
91532340|NCT03389893|182941354|SUPERIORITY||Geometric Mean Ratio|0.16||||0.006|TWO_SIDED|95.0|0.04|0.58|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.58|0.04|0.006
91751489|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0104
91751490|NCT00468845|183395796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6978
91506486|NCT00116831|182883689|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.1||||||95.0||||||||||||
91506487|NCT00116831|182883690|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.88||||||95.0||||||||||||
91506488|NCT00116831|182883691|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-47.23||||||95.0||||||||||||
91506489|NCT00116831|182883692|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-16.9||||||95.0||||||||||||
91506490|NCT00116831|182883694|SUPERIORITY_OR_OTHER||Ratio to GLP as % difference from GLP|30.591||||||95.0||||||||||||
91506491|NCT00116831|182883695|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.642||||||95.0||||||||||||
91506492|NCT00116831|182883696|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.316||||||95.0||||||||||||
91506493|NCT00116831|182883697|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|15.731||||||95.0||||||||||||
91506494|NCT00116831|182883698|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|3.998||||||95.0||||||||||||
91532341|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.8||||0.724|TWO_SIDED|95.0|0.23|2.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||2.82|0.23|0.724
91532342|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.27||||0.033|TWO_SIDED|95.0|0.08|0.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||0.89|0.08|0.033
91532343|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.36||||0.073|TWO_SIDED|95.0|0.12|1.1|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||1.10|0.12|0.073
91506495|NCT00116831|182883699|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|11.728||||||95.0||||||||||||
91506496|NCT00116831|182883700|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-6.768||||||95.0||||||||||||
91506497|NCT00116831|182883701|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-14.478||||||95.0||||||||||||
91506498|NCT00116831|182883702|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.462||||||95.0||||||||||||
91506499|NCT00116831|182883703|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.0164||||||95.0||||||||||||
91751491|NCT03840525|183395806|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted. No group comparisons were done due to the fact that this was a feasibility trial and not an efficacy trial. 80% was used as the benchmark for acceptability.|||
91751492|NCT03840525|183395807|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics was conducted to determine acceptability for both the qigong and sham qigong group. No between group comparisons were conducted. A benchmark of 80% was used to determine acceptability.|||
91751493|NCT03840525|183395808|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted to determine acceptability. Benchmark for acceptability was set at 80% of participant attending at least 70% of the classes.|||
91751494|NCT00787930|183395826|SUPERIORITY_OR_OTHER||||||>|0.05||||||a priori threshold for significance was 0.05|Chi-squared|||||||>0.05
91751495|NCT00787930|183395827|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|df=1||||||1.00
91751496|NCT00787930|183395828|SUPERIORITY_OR_OTHER|||||||0.6056||||||No adjustment for multiple comparisons|Chi-squared|df=1||||||0.6056
91751497|NCT00787930|183395829|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory hypothesis|t-stat estimated value|1.52|STANDARD_DEVIATION|8.2||0.081|ONE_SIDED|95.0|0.0||||t-test, 1 sided|missing values: 6 df=7|||||0|0.081
91751498|NCT00787930|183395830|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory analyses|t-stat estimated value|1.47|STANDARD_DEVIATION|6.56||0.091|ONE_SIDED|95.0|0.0|||no adjustment for multiple analyses|t-test, 1 sided|missing values: 5 df=7|||||0|0.091
91751499|NCT00628589|183395900|SUPERIORITY|LS mean was used in the primary efficacy analysis||||||0.0004|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||0.0004
91751500|NCT00628589|183395900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||<0.0001
91751501|NCT00628589|183395901|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
91751502|NCT00628589|183395901|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91751503|NCT00628589|183395902|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
91751504|NCT00628589|183395902|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91751505|NCT01688739|183395921|OTHER||Ratio of Geometric Means|1.1||||0.7595|TWO_SIDED|90.0|0.8|1.4|||ANCOVA||Migraine participants / Healthy Participants|||1.4|0.8|0.7595
91751506|NCT01688739|183395923|OTHER||Ratio of Geometric Means|1.1||||0.5481|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5481
91751507|NCT01688739|183395924|OTHER||Ratio of Geometric Means|1.1||||0.5506|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5506
91751508|NCT02406443|183395926|SUPERIORITY||Mean Difference (Final Values)|46.0|||=|0.012|TWO_SIDED||||||Regression, Linear|||||||=0.012
91751509|NCT02406443|183395927|SUPERIORITY||Median Difference (Final Values)|5.7||||0.4|TWO_SIDED||||||Regression, Linear|||||||0.40
91751510|NCT02406443|183395928|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.15|TWO_SIDED||||||Regression, Linear|||||||0.15
91751511|NCT02406443|183395929|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
91506500|NCT00116831|182883704|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.118||||||95.0||||||||||||
91506501|NCT00116831|182883705|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.14||||||95.0||||||||||||
91751512|NCT02406443|183395930|SUPERIORITY||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
91751513|NCT02406443|183395931|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
91751514|NCT06276881|183395948|SUPERIORITY|||||||0.37|||||||t-test, 1 sided||||Multiple regression analysis|||.37
91751515|NCT06276881|183395949|SUPERIORITY|||||||0.07|||||||ANOVA|||||||.07
91506502|NCT01344369|182883725|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.44|||||TWO_SIDED|90.0|93.08|112.75|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.75|93.08|
91532344|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.73||||0.579|TWO_SIDED|95.0|0.23|2.29|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||2.29|0.23|0.579
91751516|NCT01340937|183395950|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Concentration (GMC) ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.91|||||TWO_SIDED|95.0|0.77|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.77|
91506503|NCT01344369|182883726|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.58|||||TWO_SIDED|90.0|96.66|104.66|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.66|96.66|
91532345|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.17||||0.003|TWO_SIDED|95.0|0.05|0.53|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 28||0.53|0.05|0.003
91751517|NCT01340937|183395950|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.86|||||TWO_SIDED|95.0|0.72|1.02|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.72|
91751518|NCT01340937|183395950|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.94|||||TWO_SIDED|95.0|0.79|1.12|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.12|0.79|
91751519|NCT01340937|183395950|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.63|||<|0.001|TWO_SIDED|95.0|1.35|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.35|<0.001
91751520|NCT01340937|183395951|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.48|||||TWO_SIDED|95.0|-4.31|3.35|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||3.35|-4.31|
91751521|NCT01340937|183395951|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.62|||||TWO_SIDED|95.0|-5.38|2.12|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.12|-5.38|
91751522|NCT01340937|183395951|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.16|||||TWO_SIDED|95.0|-4.89|2.58|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.58|-4.89|
91751523|NCT01340937|183395951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|7.93|||<|0.001|TWO_SIDED|95.0|3.38|13.17|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1 µg/mL||13.17|3.38|<0.001
91751524|NCT01340937|183395951|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|2.2|||<|0.001|TWO_SIDED|95.0|0.39|5.12|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 µg/mL||5.12|0.39|<0.001
91751525|NCT01340937|183395952|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.87|||||TWO_SIDED|95.0|0.76|0.98|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.98|0.76|
91751526|NCT01340937|183395952|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.85|||||TWO_SIDED|95.0|0.74|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.74|
91751527|NCT01340937|183395952|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.86|
91751528|NCT01340937|183395953|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.07|0.84|
91751529|NCT01340937|183395953|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.86|
91751530|NCT01340937|183395953|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.9|1.14|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.14|0.90|
91751531|NCT01340937|183395954|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.91|1.04|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.04|0.91|
91751532|NCT01340937|183395954|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
91751533|NCT01340937|183395954|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.05|||||TWO_SIDED|95.0|0.98|1.13|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.13|0.98|
91506504|NCT01344369|182883727|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.85|||||TWO_SIDED|90.0|96.43|105.48|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.48|96.43|
91506505|NCT01344369|182883728|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.59|||||TWO_SIDED|90.0|93.69|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.00|93.69|
91506506|NCT01344369|182883729|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.68|||||TWO_SIDED|90.0|92.76|100.77|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.77|92.76|
91506507|NCT01344369|182883730|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.44|||||TWO_SIDED|90.0|92.22|100.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.84|92.22|
91506508|NCT00526058|182883746|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.||||||0.005|TWO_SIDED|90.0|||||ANOVA|||||||0.005
91506509|NCT00735371|182883754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
91506510|NCT00735371|182883754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91506511|NCT00735371|182883754|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91506512|NCT00735371|182883755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0235||95.0|||||Cochran-Mantel-Haenszel|||||||0.0235
91506513|NCT00735371|182883755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91506514|NCT00735371|182883755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
91506515|NCT04630093|182883781|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline vs. 6 months after receiving panel-based pharmacogenetic testing||||0.001
91506516|NCT04120610|182883813|OTHER||Correlation|0.26|||||TWO_SIDED|95.0|0.1|0.41||||||Descriptive analysis of endpoint with no hypothesis.||0.41|0.10|
91506517|NCT04120610|182883814|OTHER||Correlation|-0.26|||||TWO_SIDED|95.0|-0.46|-0.03||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.03|-0.46|
91506518|NCT04120610|182883814|OTHER||Correlation|-0.33|||||TWO_SIDED|95.0|-0.51|-0.12||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.51|
91506519|NCT04120610|182883814|OTHER||Correlation|-0.13|||||TWO_SIDED|95.0|-0.38|0.14||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||0.14|-0.38|
91506520|NCT04120610|182883815|OTHER||Correlation|-0.34|||||TWO_SIDED|95.0|-0.52|-0.12||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.52|
91506521|NCT04120610|182883815|OTHER||Correlation|-0.35|||||TWO_SIDED|95.0|-0.52|-0.15||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.15|-0.52|
91506522|NCT04120610|182883815|OTHER||Correlation|-0.24|||||TWO_SIDED|95.0|-0.47|0.02||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||0.02|-0.47|
91506523|NCT04120610|182883816|OTHER||Correlation|0.15|||||TWO_SIDED|95.0|-0.08|0.36||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.36|-0.08|
91506524|NCT04120610|182883816|OTHER||Correlation|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.39|-0.02|
91506525|NCT04120610|182883816|OTHER||Correlation|0.24|||||TWO_SIDED|95.0|-0.02|0.47||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.47|-0.02|
91506526|NCT03712410|182883826|OTHER|Group Comparisons||||||0.186||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Kruskal-Wallis|||||||0.1860
91506527|NCT03712410|182883826|OTHER|Group Comparisons||||||0.2752||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Kruskal-Wallis|||||||0.2752
91506528|NCT03712410|182883826|OTHER|Group Comparisons||||||0.6233||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Kruskal-Wallis|||||||0.6233
91506529|NCT03712410|182883827|OTHER|Group Comparison||||||0.5638||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Wilcoxon (Mann-Whitney)|||||||0.5638
91506530|NCT03712410|182883827|OTHER|Group Comparisons||||||0.9848||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Wilcoxon (Mann-Whitney)|||||||0.9848
91506531|NCT03712410|182883827|OTHER|Group Comparisons||||||0.9169||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Wilcoxon (Mann-Whitney)|||||||0.9169
91506532|NCT03712410|182883828|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
91532346|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.52||||0.297|TWO_SIDED|95.0|0.15|1.81|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||1.81|0.15|0.297
91506533|NCT03712410|182883828|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
91506534|NCT03712410|182883828|OTHER|Group Comparisons||||||0.0155||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||0.0155
91506535|NCT03712410|182883828|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
91751534|NCT01340937|183395955|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|1.03|||||TWO_SIDED|95.0|0.96|1.1|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.10|0.96|
91751535|NCT01340937|183395955|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
91751536|NCT01340937|183395955|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.06|0.92|
91506536|NCT03712410|182883828|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
91751537|NCT01340937|183395955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.2|||<|0.001|TWO_SIDED|95.0|1.11|1.29|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.29|1.11|<0.001
91751538|NCT01340937|183395956|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.89|||||TWO_SIDED|95.0|0.83|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.83|
91751539|NCT01340937|183395956|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.78|||||TWO_SIDED|95.0|0.72|0.83|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.83|0.72|
91751540|NCT01340937|183395956|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.87|||||TWO_SIDED|95.0|0.81|0.94|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.94|0.81|
91751541|NCT01340937|183395956|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.67||||0.419|TWO_SIDED|95.0|0.62|0.73|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||0.73|0.62|0.419
91751542|NCT01340937|183395957|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
91751543|NCT01340937|183395957|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.93|||||TWO_SIDED|95.0|0.83|1.05|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.83|
91506537|NCT03712410|182883828|OTHER|Group Comparisons||||||0.0504||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||0.0504
91506538|NCT00314236|182883836|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||ANCOVA|||||||0.011
91506539|NCT00314236|182883837|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||ANCOVA|||||||0.033
91506540|NCT01465464|182883840|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.435|TWO_SIDED|95.0|0.878|1.352|||Log Rank|||||1.352|0.878|0.435
91506541|NCT02739269|182883882|SUPERIORITY|||||||0.479|||||||Chi-squared|||||||0.479
91506542|NCT02739269|182883883|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
91751544|NCT01340937|183395957|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.96|||||TWO_SIDED|95.0|0.85|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.85|
91751545|NCT01340937|183395957|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.17|0.90|<0.001
91751546|NCT01340937|183395958|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.78|||||TWO_SIDED|95.0|0.72|0.85|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.85|0.72|
91506543|NCT02244580|182883884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0018|TWO_SIDED|95.0|0.246|0.726|||Regression, Cox|||||0.726|0.246|0.0018
91506544|NCT02244580|182883885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.001|TWO_SIDED|95.0|0.25|0.71|||Regression, Cox|||||0.71|0.25|0.001
91506545|NCT02136576|182883891|SUPERIORITY|||||||0.72||||||"This p-value is for the Air Schiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||0.72
91506546|NCT02136576|182883891|SUPERIORITY|||||||0.93||||||"This p-value is for the Air VAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
91506547|NCT02136576|182883891|SUPERIORITY|||||||0.77||||||"This p-value is for the WaterSchiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.77
91506548|NCT02136576|182883891|SUPERIORITY|||||||0.93||||||"This p-value is for the WaterVAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
91506549|NCT00923559|182883899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.69|STANDARD_ERROR_OF_MEAN|3.04||0.006||95.0|2.64|14.74||Null hypothesis MIP and CHC care should yield equal outcomes. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 68.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||14.74|2.64|.006
91751547|NCT01340937|183395958|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.8|||||TWO_SIDED|95.0|0.73|0.87|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.87|0.73|
91751548|NCT01340937|183395958|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.93|
91751549|NCT01340937|183395958|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.51|||<|0.001|TWO_SIDED|95.0|1.37|1.66|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.66|1.37|<0.001
91506550|NCT00923559|182883900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|1.06||0.018|TWO_SIDED|95.0|0.46|4.68||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 69.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||4.68|0.46|.018
91506551|NCT00923559|182883901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.24||0.266|TWO_SIDED|95.0|-0.21|0.75||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom = 73.4||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.75|-0.21|.266
91506552|NCT00923559|182883902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|0.0|0.32||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.32|0.00|.052
91506553|NCT00923559|182883903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.031|TWO_SIDED|95.0|-1.61|-0.08|||Regression, Linear|Degrees of freedom (df) = 61.2||see under the PIR-GAS||-0.08|-1.61|.031
91506554|NCT00923559|182883904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.158|TWO_SIDED|95.0|-0.05|0.31|||Mixed Models Analysis|Degrees of freedom (df) = 71.2||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.31|-0.05|.158
91506555|NCT04903249|182883923|OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
91506556|NCT04903249|182883924|OTHER|||||||0.293|||||||t-test, 2 sided|||||||0.293
91506557|NCT04903249|182883925|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
91506558|NCT04903249|182883931|OTHER|||||||0.025|||||||t-test, 2 sided|||||||0.025
91506559|NCT04903249|182883932|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91506560|NCT04903249|182883933|OTHER|||||||0.327|||||||t-test, 2 sided|||||||.327
91751550|NCT01340937|183395959|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Titer (GMT) ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.86|||||TWO_SIDED|95.0|0.76|0.96|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.76|
91751551|NCT01340937|183395959|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.88|||||TWO_SIDED|95.0|0.79|0.99|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.99|0.79|
91751552|NCT01340937|183395959|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.92|1.15|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.15|0.92|
91751553|NCT01340937|183395960|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.94|||||TWO_SIDED|95.0|0.84|1.05|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.84|
91751554|NCT01340937|183395960|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.91|||||TWO_SIDED|95.0|0.82|1.02|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.82|
91751555|NCT01340937|183395960|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
91751556|NCT01340937|183395961|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|1.06|||||TWO_SIDED|95.0|0.92|1.22|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.22|0.92|
91751557|NCT01340937|183395961|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.26|0.95|
91751558|NCT01340937|183395961|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.9|1.19|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.19|0.90|
91751559|NCT01340937|183395962|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.34|||||TWO_SIDED|95.0|-1.23|0.3|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.30|-1.23|
91751560|NCT01340937|183395962|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-0.34|||||TWO_SIDED|95.0|-1.23|0.32|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.32|-1.23|
91751561|NCT01340937|183395962|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.64|0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.66|-0.64|
91751562|NCT01340937|183395962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.92|||<|0.001|TWO_SIDED|95.0|0.2|2.9|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.90|0.20|<0.001
91751563|NCT01340937|183395963|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|0.25|||||TWO_SIDED|95.0|-3.74|4.24|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.24|-3.74|
91751564|NCT01340937|183395963|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.35|||||TWO_SIDED|95.0|-5.26|2.57|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.57|-5.26|
91506561|NCT04903249|182883934|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
91506562|NCT04903249|182883935|OTHER|||||||0.424|||||||t-test, 2 sided|||||||0.424
91506563|NCT04903249|182883936|OTHER|||||||0.279|||||||t-test, 2 sided|||||||0.279
91506564|NCT04903249|182883937|OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
91506565|NCT01951157|182883938|SUPERIORITY||The exact binomial estimator|29.2|||||TWO_SIDED|95.0|13.2|48.4||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.||48.4|13.2|
91506566|NCT01951157|182883938|SUPERIORITY||The exact binomial estimator|19.0|||||TWO_SIDED|95.0|5.7|37.9||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||37.9|5.7|
91506567|NCT01951157|182883938|SUPERIORITY||The exact binomial estimator|28.0|||||TWO_SIDED|95.0|12.6|46.7||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||46.7|12.6|
91506568|NCT01951157|182883939|SUPERIORITY|Pre-specified|||||=|0.3873|||||||Log Rank|||||||= 0.3873
91506569|NCT01951157|182883943|SUPERIORITY|Pre-specified|||||=|0.0177|||||||Log Rank|||||||= 0.0177
91506570|NCT01951157|182883944|SUPERIORITY_OR_OTHER_LEGACY|Pre-specified||||||0.3526|||||||Log Rank|||||||0.3526
91506571|NCT01951157|182883945|SUPERIORITY|Pre-specified||||||0.9026|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9026
91506572|NCT01951157|182883945|SUPERIORITY|||||||0.9862|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9862
91506573|NCT01951157|182883945|SUPERIORITY|||||||0.8057|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.||||0.8057
91506574|NCT05218018|182883951|OTHER|||||||0.002|||||||t-test, 2 sided|||||||.002
91751565|NCT01340937|183395963|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.64|||||TWO_SIDED|95.0|-5.56|2.28|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.28|-5.56|
91751566|NCT01340937|183395963|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-2.35|||<|0.001|TWO_SIDED|95.0|-6.02|2.09|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.09|-6.02|<0.001
91751567|NCT01340937|183395964|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|-0.16|||||TWO_SIDED|95.0|-0.91|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.91|
91751568|NCT01340937|183395964|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|-0.16|||||TWO_SIDED|95.0|-0.9|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.90|
91506575|NCT00828191|182883975|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-2.5||||0.52|TWO_SIDED|95.0|-9.4|4.4|||Fisher Exact|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||4.4|-9.4|0.52
91506576|NCT00828191|182883976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.48||0.54|TWO_SIDED|95.0|-7.6|4.0|||ANOVA|||||4.0|-7.6|0.54
91506577|NCT00828191|182883977|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.62|TWO_SIDED|95.0|-8.8|4.8|||Fisher Exact|||||4.8|-8.8|0.62
91506578|NCT01883427|182883978|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Not significant|Wilcoxon (Mann-Whitney)|||Too few included to reach power||||>0.05
91506579|NCT02013167|182883980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.012|TWO_SIDED|95.0|0.55|0.93|||Stratified Log Rank|Stratified by age (\< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.|||0.93|0.55|0.012
91506580|NCT02013167|182883981|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|9.6|26.2|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||26.2|9.6|< 0.001
91506581|NCT02013167|182883982|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|19.3|||<|0.001|TWO_SIDED|95.0|9.9|28.7|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||28.7|9.9|< 0.001
91506582|NCT02013167|182883983|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.43|0.71|||||The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.|||0.71|0.43|
91506583|NCT00483223|182884018|OTHER|||||||0.54|||||||t-test, 2 sided|||H0: no association between expression ratio and response rate Ha: Participants with expression ratio greater than 2 would have higher response rate||||0.54
91506584|NCT04041869|182884022|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||In order to test the effect of the intervention on physical activity, linear mixed models examined changes in steps per day from study baseline (week 0) to the end of the active intervention (week 8).||||<0.01
91506585|NCT01336738|182884032|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.164||0.6803|TWO_SIDED|80.0|-0.13|0.29||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.13|0.6803
91506586|NCT01336738|182884032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.0017|TWO_SIDED|80.0|-0.71|-0.28||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.28|-0.71|0.0017
91506587|NCT01336738|182884032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.168||0.0003|TWO_SIDED|80.0|-0.8|-0.36||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.80|0.0003
91751569|NCT01340937|183395964|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.63|0.62|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.62|-0.63|
91751570|NCT01340937|183395964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|1.28|||<|0.001|TWO_SIDED|95.0|0.46|3.33|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.33|0.46|<0.001
91751571|NCT01340937|183395965|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|1.73|||||TWO_SIDED|95.0|0.37|3.4|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.40|0.37|
91751572|NCT01340937|183395965|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|0.36|||||TWO_SIDED|95.0|-0.77|1.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.63|-0.77|
91506588|NCT01336738|182884032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|80.0|-0.91|-0.5||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.50|-0.91|<0.0001
91506589|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|5.292||0.4757|TWO_SIDED|95.0|-6.64|14.2||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.20|-6.64|0.4757
91751573|NCT01340937|183395965|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.36|||||TWO_SIDED|95.0|-3.03|0.15|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.15|-3.03|
91751574|NCT01340937|183395965|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.72|||<|0.001|TWO_SIDED|95.0|-0.59|3.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.14|-0.59|<0.001
91751575|NCT01340937|183395966|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-1.35|||||TWO_SIDED|95.0|-5.17|2.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.47|-5.17|
91751576|NCT01340937|183395966|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-3.06|||||TWO_SIDED|95.0|-6.79|0.67|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.67|-6.79|
91532347|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.48||||0.326|TWO_SIDED|95.0|0.11|2.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||2.12|0.11|0.326
91751577|NCT01340937|183395966|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.71|||||TWO_SIDED|95.0|-5.37|1.94|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.94|-5.37|
91751578|NCT01340937|183395966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-4.7|||<|0.001|TWO_SIDED|95.0|-7.73|-0.86|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.86|-7.73|<0.001
91751579|NCT01340937|183395967|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|2.77|||||TWO_SIDED|95.0|-1.83|7.39|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.39|-1.83|
91751580|NCT01340937|183395967|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|2.41|||||TWO_SIDED|95.0|-2.21|7.06|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.06|-2.21|
91751581|NCT01340937|183395967|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.36|||||TWO_SIDED|95.0|-5.14|4.42|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.42|-5.14|
91751582|NCT01340937|183395967|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.28|||<|0.001|TWO_SIDED|95.0|-1.7|8.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.85|-1.70|<0.001
91751583|NCT01340937|183395968|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-4.12|||||TWO_SIDED|95.0|-7.69|-0.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.63|-7.69|
91751584|NCT01340937|183395968|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-4.17|||||TWO_SIDED|95.0|-7.75|-0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.66|-7.75|
91751585|NCT01340937|183395968|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.07|||||TWO_SIDED|95.0|-3.32|3.2|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.20|-3.32|
91751586|NCT01340937|183395968|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|2.85|||<|0.001|TWO_SIDED|95.0|-0.85|7.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.36|-0.85|<0.001
91751587|NCT01340937|183395969|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91751588|NCT01340937|183395969|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91751589|NCT01340937|183395969|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91532348|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.52||||0.401|TWO_SIDED|95.0|0.11|2.42|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||2.42|0.11|0.401
91506590|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|5.296||0.8031|TWO_SIDED|95.0|-9.11|11.75||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.75|-9.11|0.8031
91506591|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.22|STANDARD_ERROR_OF_MEAN|5.364||0.549|TWO_SIDED|95.0|-13.78|7.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.34|-13.78|0.5490
91506592|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.34||0.0051|TWO_SIDED|95.0|-25.58|-4.55||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.55|-25.58|0.0051
91506593|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|5.02||0.6291|TWO_SIDED|95.0|-12.31|7.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.46|-12.31|0.6291
91506594|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|5.001||0.4396|TWO_SIDED|95.0|-5.98|13.72||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.72|-5.98|0.4396
91506595|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.56|STANDARD_ERROR_OF_MEAN|5.03||0.1934|TWO_SIDED|95.0|-16.46|3.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.34|-16.46|0.1934
91506596|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.32|STANDARD_ERROR_OF_MEAN|5.039||0.0007|TWO_SIDED|95.0|-27.24|-7.4||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.40|-27.24|0.0007
91506597|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|5.201||0.5479|TWO_SIDED|95.0|-7.11|13.37||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.37|-7.11|0.5479
91506598|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.14|STANDARD_ERROR_OF_MEAN|5.209||0.4276|TWO_SIDED|95.0|-14.39|6.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||6.12|-14.39|0.4276
91506599|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.38|STANDARD_ERROR_OF_MEAN|5.235||0.1596|TWO_SIDED|95.0|-17.69|2.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.92|-17.69|0.1596
91506600|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.83|STANDARD_ERROR_OF_MEAN|5.198|<|0.0001|TWO_SIDED|95.0|-33.06|-12.6||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.60|-33.06|<0.0001
91506601|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.855||0.8509|TWO_SIDED|95.0|-12.63|10.43||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.43|-12.63|0.8509
91506602|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.53|STANDARD_ERROR_OF_MEAN|5.913||0.1505|TWO_SIDED|95.0|-20.17|3.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|-20.17|0.1505
91506603|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.62|STANDARD_ERROR_OF_MEAN|5.94||0.2662|TWO_SIDED|95.0|-18.31|5.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.08|-18.31|0.2662
91506604|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.52|STANDARD_ERROR_OF_MEAN|5.818||0.0003|TWO_SIDED|95.0|-32.97|-10.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-10.07|-32.97|0.0003
91532349|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.81||||0.705|TWO_SIDED|95.0|0.28|2.4|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||2.40|0.28|0.705
91532350|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.72||||0.538|TWO_SIDED|95.0|0.25|2.08|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.08|0.25|0.538
91506605|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|6.94||0.7724|TWO_SIDED|95.0|-15.68|11.66||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.66|-15.68|0.7724
91751590|NCT01340937|183395969|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.66|||<|0.001|TWO_SIDED|95.0|0.18|2.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.36|0.18|<0.001
91751591|NCT01340937|183395970|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91751592|NCT01340937|183395970|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
91751593|NCT01340937|183395970|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
91751594|NCT01340937|183395970|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.0|||<|0.001|TWO_SIDED|95.0|-0.2|1.24|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.24|-0.20|<0.001
91751595|NCT01340937|183395971|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91751596|NCT01340937|183395971|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91751597|NCT01340937|183395971|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
91751598|NCT01340937|183395971|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.33|||<|0.001|TWO_SIDED|95.0|0.05|1.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.85|0.05|<0.001
91506606|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.986||0.9202|TWO_SIDED|95.0|-14.47|13.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.07|-14.47|0.9202
91751599|NCT01340937|183395972|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.07|||<|0.001|TWO_SIDED|95.0|0.98|1.17|||Analysis of Covariance|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.17|0.98|<0.001
91751600|NCT01340937|183395973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.79|<0.001
91751601|NCT01340937|183395974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.74||||0.035|TWO_SIDED|95.0|0.66|0.83|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.83|0.66|0.035
91751602|NCT01340937|183395975|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.31|||<|0.001|TWO_SIDED|95.0|1.17|1.46|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.46|1.17|<0.001
91751603|NCT01340937|183395976|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.12|||<|0.001|TWO_SIDED|95.0|-1.11|2.58|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.58|-1.11|<0.001
91751604|NCT01340937|183395977|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-0.16|||<|0.001|TWO_SIDED|95.0|-2.41|3.22|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.22|-2.41|<0.001
91751605|NCT01340937|183395978|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|1.15|||<|0.001|TWO_SIDED|95.0|-2.13|5.47|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||5.47|-2.13|<0.001
91751606|NCT01340937|183395979|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.0|||<|0.001|TWO_SIDED|95.0|-0.39|7.4|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.40|-0.39|<0.001
91751607|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.92|||<|0.001|TWO_SIDED|95.0|0.82|1.04|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 1||1.04|0.82|<0.001
91751608|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 3||1.06|0.84|<0.001
91751609|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.89|1.12|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 4||1.12|0.89|<0.001
91751610|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 5||1.07|0.80|<0.001
91751611|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.87|||<|0.001|TWO_SIDED|95.0|0.77|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6A||0.99|0.77|<0.001
91751612|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.79||||0.055|TWO_SIDED|95.0|0.64|0.96|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6B||0.96|0.64|0.055
91751613|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 7F||0.99|0.80|<0.001
91532351|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.92||||0.892|TWO_SIDED|95.0|0.25|3.34|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||3.34|0.25|0.892
91751614|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.13|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 9V||1.13|0.88|<0.001
91751615|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 14||1.10|0.82|<0.001
91751616|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 18C||1.00|0.79|<0.001
91751617|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.91|||<|0.001|TWO_SIDED|95.0|0.8|1.03|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19A||1.03|0.80|<0.001
91751618|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.08|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19F||1.08|0.87|<0.001
91532352|NCT03389893|182941355|SUPERIORITY||Geometric Mean Ratio|0.74||||0.624|TWO_SIDED|95.0|0.21|2.56|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.56|0.21|0.624
91506607|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|6.998||0.8183|TWO_SIDED|95.0|-15.4|12.18||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.18|-15.40|0.8183
91506608|NCT01336738|182884033|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.96|STANDARD_ERROR_OF_MEAN|6.821||0.0003|TWO_SIDED|95.0|-38.4|-11.53||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-11.53|-38.40|0.0003
91506609|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.2327|TWO_SIDED|80.0|-0.1|0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.03|-0.10|0.2327
91751619|NCT01340937|183395980|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.9|||<|0.001|TWO_SIDED|95.0|0.77|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 23F||1.06|0.77|<0.001
91751620|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||||TWO_SIDED|95.0|-18.8|-8.4|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \<38.0°C||-8.4|-18.8|
91751621|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-0.9|8.3|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38°C and \<38.5°||8.3|-0.9|
91751622|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|4.8|11.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38.5°C and \<39.5°||11.9|4.8|
91751623|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.2|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=39.5°C||2.2|-0.7|
91751624|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||||TWO_SIDED|95.0|-16.6|-5.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \<38.0°C||-5.9|-16.6|
91751625|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.4|7.8|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \>=38.0°C and \<38.5°C||7.8|-1.4|
91751626|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||||TWO_SIDED|95.0|4.6|11.6|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=38.5°C and \<39.5°C||11.6|4.6|
91506610|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.048||0.358|TWO_SIDED|80.0|-0.08|0.04||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.04|-0.08|0.3580
91506611|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0036|TWO_SIDED|80.0|-0.2|-0.07||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.07|-0.20|0.0036
91751627|NCT01340937|183395982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.1|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=39.5°C||2.1|-0.7|
91751628|NCT00046930|183395983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Log Rank|Stratified on age (\< 70 vs. \>=70) and type of leukemia (de novo AML, secondary RAEB-t, or secondary RAEB AML)||The study was designed to have 80% power to detect a non-proportional hazards difference in OS at the one-sided 0.025 significance level of 30.2% vs 39.6%, 12.8% vs 27.1% and 7.0% vs 14.0% at 1 years, 2 years, and full information for zosuquidar and placebo, respectively.||||0.28
91751629|NCT00046930|183395984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||95.0|||||Log Rank|Stratified on age and type of leukemia||||||0.16
91751630|NCT00046930|183395985|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.617|TWO_SIDED|95.0|0.77|1.65||Test was stratified on age and type of leukemia.|Mantel Haenszel||Zosuquidar/Placebo|Test of difference in the CR (complete remission) rate between the arms.||1.65|0.77|0.617
91751631|NCT01694108|183396010|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Whitney-test comparing the decisional conflict scores of participating mothers vs. declining mothers.||||||<0.001
91751632|NCT01657760|183396027|EQUIVALENCE|80% power to detect difference p\<0.05 two tailed|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.87|TWO_SIDED|||||ANOVA, uncorrected for MC.|ANOVA|||||||0.87
91751633|NCT02124512|183396036|SUPERIORITY||||||>|0.05||||||The p-value was calculated to be \>0.05.|ANOVA|||Comparison of the pre- and post-treatment timecourse between untreated and rifaximin-treated participants.||||>0.05
91751634|NCT02124512|183396037|SUPERIORITY|||||||0.12||||||unpaired Student's t-test|t-test, 2 sided|||Treatment difference (change in placebo pre- and post-treatment versus change in rifaximin pre- and post-treatment).||||0.12
91751635|NCT01974752|183396070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.3195|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Factor for treatment and liver metastases|A hazard ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.27|0.48|0.3195
91506612|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.1251|TWO_SIDED|80.0|-0.12|0.01||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.01|-0.12|0.1251
91751636|NCT01974752|183396072|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.94||||0.1284|TWO_SIDED|95.0|0.88|1.02|||ANCOVA|ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.|A geometric least squares mean ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.02|0.88|0.1284
91751637|NCT01974752|183396073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.4011|TWO_SIDED|95.0|0.39|1.46|||Log Rank|||||1.46|0.39|0.4011
91751638|NCT00294645|183396170|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Modified Peto-Peto|A one-sided test was used.||Null hypothesis: control rate = remote rate||||<0.0001
91751639|NCT00909545|183396216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|2.03||0.9834|TWO_SIDED|95.0|-3.99|4.07||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.||4.07|-3.99|0.9834
91751640|NCT00909545|183396216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.97||0.5761|TWO_SIDED|95.0|-5.01|2.8||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.||2.80|-5.01|0.5761
91751641|NCT00909545|183396216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|2.01||0.322|TWO_SIDED|95.0|-5.98|1.99||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.||1.99|-5.98|0.322
91751642|NCT00909545|183396217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|STANDARD_ERROR_OF_MEAN|1.1587||0.1383|TWO_SIDED|95.0|0.0196|1.8411|||Fisher Exact|||The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||1.8411|0.0196|0.1383
91751643|NCT00909545|183396217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1086|STANDARD_ERROR_OF_MEAN|0.1114||0.0248|TWO_SIDED|95.0|0.0123|0.9591|||Fisher Exact|||The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.9591|0.0123|0.0248
91751644|NCT00909545|183396217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.024|STANDARD_ERROR_OF_MEAN|1.1035|<|0.0001|TWO_SIDED|95.0|0.0028|0.2087|||Fisher Exact|||The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.2087|0.0028|<0.0001
91751645|NCT00909545|183396218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2324|TWO_SIDED|95.0|-0.3|1.22|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||1.22|-0.30|0.2324
91751646|NCT00909545|183396218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.73|0.73|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||0.73|-0.73|1
91506613|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.066||0.3466|TWO_SIDED|80.0|-0.11|0.06||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.06|-0.11|0.3466
91532353|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-9.53||||0.019|TWO_SIDED|95.0|-17.44|-1.63|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference.)|Day 3, Lesional||-1.63|-17.44|0.019
91751647|NCT00909545|183396218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.37||0.4675|TWO_SIDED|95.0|-1.02|0.47|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.47|-1.02|0.4675
91751648|NCT00909545|183396219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4648|TWO_SIDED|95.0|-1.03|2.23|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.23|-1.03|0.4648
91751649|NCT00909545|183396219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.8||0.525|TWO_SIDED|95.0|-2.09|1.07|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||1.07|-2.09|0.525
91751650|NCT00909545|183396219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.81||0.3674|TWO_SIDED|95.0|-2.36|0.88|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.88|-2.36|0.3674
91751651|NCT00909545|183396220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.579|TWO_SIDED|95.0|-3.8|2.14|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.14|-3.80|0.579
91751652|NCT00909545|183396220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.46||0.7778|TWO_SIDED|95.0|-3.3|2.48|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||2.48|-3.30|0.7778
91751653|NCT00909545|183396220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|1.48||0.669|TWO_SIDED|95.0|-3.58|2.31|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||2.31|-3.58|0.669
91506614|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.0439|TWO_SIDED|80.0|-0.2|-0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.20|0.0439
91506615|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.067||0.004|TWO_SIDED|80.0|-0.27|-0.09||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.27|0.0040
91506616|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.065||0.0009|TWO_SIDED|80.0|-0.29|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.29|0.0009
91506617|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.1405|TWO_SIDED|80.0|-0.23|0.02||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.23|0.1405
91506618|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.097||0.0067|TWO_SIDED|80.0|-0.36|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.36|0.0067
91506619|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.098||0.0001|TWO_SIDED|80.0|-0.5|-0.24||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.24|-0.50|0.0001
91751654|NCT00909545|183396221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6677|TWO_SIDED|95.0|-0.27|0.17|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.||0.17|-0.27|0.6677
91751655|NCT00909545|183396221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1755|TWO_SIDED|95.0|-0.36|0.07|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.||0.07|-0.36|0.1755
91751656|NCT00909545|183396221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1463|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.||0.06|-0.38|0.1463
91532354|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.837|TWO_SIDED|95.0|-11.47|9.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Lesional||9.32|-11.47|0.837
91751657|NCT00909545|183396222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7111|TWO_SIDED|95.0|-3.3|2.26|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.||2.26|-3.30|0.7111
91751658|NCT00909545|183396222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|1.36||0.3237|TWO_SIDED|95.0|-1.35|4.04|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.||4.04|-1.35|0.3237
91751659|NCT00909545|183396222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|1.4||0.3658|TWO_SIDED|95.0|-1.51|4.05|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.||4.05|-1.51|0.3658
91751660|NCT00909545|183396223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.32||0.0608|TWO_SIDED|95.0|-0.12|5.13|||ANCOVA|||Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.||5.13|-0.12|0.0608
91751661|NCT00909545|183396223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|1.36||0.6445|TWO_SIDED|95.0|-2.07|3.33|||ANCOVA|||Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.||3.33|-2.07|0.6445
91751662|NCT00909545|183396223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.52||0.1336|TWO_SIDED|95.0|-0.63|4.67|||ANCOVA|||Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.||4.67|-0.63|0.1336
91751663|NCT00909545|183396224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.56||0.3533|TWO_SIDED|95.0|-1.64|0.59|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.||0.59|-1.64|0.3533
91751664|NCT00909545|183396224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.56||0.4045|TWO_SIDED|95.0|-1.59|0.65|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.||0.65|-1.59|0.4045
91751665|NCT00909545|183396224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.57||0.7049|TWO_SIDED|95.0|-1.36|0.92|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.||0.92|-1.36|0.7049
91751666|NCT00909545|183396225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19|STANDARD_ERROR_OF_MEAN|1.8||0.2278|TWO_SIDED|95.0|-1.4|5.79|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.79|-1.40|0.2278
91751667|NCT00909545|183396225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|1.86||0.356|TWO_SIDED|95.0|-1.97|5.42|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.42|-1.97|0.356
91751668|NCT00909545|183396225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.83||0.26|TWO_SIDED|95.0|-1.56|5.71|||ANCOVA|||Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.||5.71|-1.56|0.2600
91751669|NCT00909545|183396232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2632|STANDARD_ERROR_OF_MEAN|1.159||0.1384|TWO_SIDED|95.0|0.5432|50.9977||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||50.9977|0.5432|0.1384
91751670|NCT00909545|183396232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.625|STANDARD_ERROR_OF_MEAN|1.097||0.0024|TWO_SIDED|95.0|1.8214|134.0403||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||134.0403|1.8214|0.0024
91751671|NCT00909545|183396232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|5.7004|438.5694||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||438.5694|5.7004|<.0001
91751672|NCT00909545|183396233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.754|STANDARD_ERROR_OF_MEAN|0.6715||0.7735|TWO_SIDED|95.0|0.2022|2.812|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8120|0.2022|0.7735
91751673|NCT00909545|183396233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8143|STANDARD_ERROR_OF_MEAN|0.6419||0.7385|TWO_SIDED|95.0|0.2314|2.8658|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8658|0.2314|0.7385
91751674|NCT00909545|183396233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9048|STANDARD_ERROR_OF_MEAN|0.6463||0.6823|TWO_SIDED|95.0|0.2549|3.2112|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||3.2112|0.2549|0.6823
91751675|NCT00909545|183396234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5263|STANDARD_ERROR_OF_MEAN|0.9188||0.2756|TWO_SIDED|95.0|0.4172|15.2975|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||15.2975|0.4172|0.2756
91751676|NCT00909545|183396234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4211|STANDARD_ERROR_OF_MEAN|0.8584||0.07|TWO_SIDED|95.0|0.8217|23.7875|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||23.7875|0.8217|0.07
91506620|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.094||0.0002|TWO_SIDED|80.0|-0.46|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.46|0.0002
91506621|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.135||0.4887|TWO_SIDED|80.0|-0.18|0.17||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.17|-0.18|0.4887
91506622|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.137||0.002|TWO_SIDED|80.0|-0.57|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.57|0.0020
91506623|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|80.0|-0.76|-0.41||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.41|-0.76|<0.0001
91506624|NCT01336738|182884034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|80.0|-0.76|-0.42||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.42|-0.76|<0.0001
91506625|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.225||0.2067|TWO_SIDED|95.0|-0.16|0.73||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.73|-0.16|0.2067
91506626|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.224||0.8602|TWO_SIDED|95.0|-0.4|0.48||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.48|-0.40|0.8602
91506627|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.225||0.92|TWO_SIDED|95.0|-0.47|0.42||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-0.47|0.9200
91751677|NCT00909545|183396234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|0.9174||0.2953|TWO_SIDED|95.0|0.3975|14.4919|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||14.4919|0.3975|0.2953
91751678|NCT00909545|183396235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.8719||0.6049|TWO_SIDED|95.0|0.2082|6.3508|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||6.3508|0.2082|0.6049
91506628|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.223||0.0399|TWO_SIDED|95.0|0.02|0.9||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.90|0.02|0.0399
91751679|NCT00909545|183396235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.7704||0.2327|TWO_SIDED|95.0|0.5081|10.4105|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||10.4105|0.5081|0.2327
91506629|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.242||0.2266|TWO_SIDED|95.0|-0.18|0.77||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.77|-0.18|0.2266
91506630|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.241||0.8493|TWO_SIDED|95.0|-0.43|0.52||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.43|0.8493
91506631|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.242||0.9511|TWO_SIDED|95.0|-0.49|0.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.46|-0.49|0.9511
91506632|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.241||0.1369|TWO_SIDED|95.0|-0.11|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.11|0.1369
91506633|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.272||0.1562|TWO_SIDED|95.0|-0.15|0.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.15|0.1562
91506634|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.272||0.4913|TWO_SIDED|95.0|-0.72|0.35||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.72|0.4913
91506635|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.272||0.513|TWO_SIDED|95.0|-0.36|0.71||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.71|-0.36|0.5130
91506636|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.269||0.0298|TWO_SIDED|95.0|0.06|1.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.12|0.06|0.0298
91506637|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.363||0.3196|TWO_SIDED|95.0|-0.35|1.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|-0.35|0.3196
91506638|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.367||0.8884|TWO_SIDED|95.0|-0.77|0.67||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.77|0.8884
91506639|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.365||0.7325|TWO_SIDED|95.0|-0.59|0.84||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.84|-0.59|0.7325
91506640|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.357||0.3395|TWO_SIDED|95.0|-0.36|1.04||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.04|-0.36|0.3395
91506641|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.41||0.7514|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7514
91506642|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.413||0.7529|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7529
91506643|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.411||0.9638|TWO_SIDED|95.0|-0.79|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.79|0.9638
91506644|NCT01336738|182884036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.404||0.0962|TWO_SIDED|95.0|-0.12|1.47||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.47|-0.12|0.0962
91506645|NCT01852292|182884046|OTHER|Double Criteria for PFS|Cox Proportional Hazard|0.646|||||TWO_SIDED|95.0|0.44|0.94||||||||0.94|0.44|
91506646|NCT01852292|182884047|OTHER|Double criteria for OS|Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.49|1.04||||||||1.04|0.49|
91751680|NCT00909545|183396235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||7.6897|0.3057|0.4534
91751681|NCT00909545|183396236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||4.8065|0.1109|0.7852
91751682|NCT00909545|183396236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.8681||0.666|TWO_SIDED|95.0|0.1824|5.482|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||5.4820|0.1824|0.666
91751683|NCT00909545|183396236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||7.6897|0.3057|0.4534
91751684|NCT00909545|183396237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||6.4433|0.0462|0.8589
91506647|NCT03240575|182884107|SUPERIORITY||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.027||0.0543|TWO_SIDED|95.0|-0.001|0.105|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.105|-0.001|0.0543
91506648|NCT03240575|182884108|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.037|0.144|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.144|0.037|0.0011
91506649|NCT03240575|182884109|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.027||0.8593|TWO_SIDED|95.0|-0.048|0.058|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.058|-0.048|0.8593
91506650|NCT03240575|182884110|SUPERIORITY||Mean Difference (Net)|0.098|STANDARD_ERROR_OF_MEAN|0.029||0.001|TWO_SIDED|95.0|0.04|0.156|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.156|0.040|0.0010
91506651|NCT04482179|182884111|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
91506652|NCT04482179|182884112|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
91506653|NCT03034954|182884121|OTHER|||||||0.3||||||Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.|Repeated Measures ANOVA|repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)||We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.||||.300
91506654|NCT03034954|182884123|OTHER|||||||0.044||||||Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).|Repeated Measures ANOVA|||A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)||||.044
91506655|NCT03034954|182884123|OTHER|||||||0.006|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.006
91506656|NCT03034954|182884126|OTHER|||||||0.15|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.15
91751685|NCT00909545|183396237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5652|STANDARD_ERROR_OF_MEAN|0.9584||0.5|TWO_SIDED|95.0|0.2392|10.241|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||10.2410|0.2392|0.5000
91751686|NCT00909545|183396237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7143|STANDARD_ERROR_OF_MEAN|0.9605||0.4609|TWO_SIDED|95.0|0.2609|11.2639|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||11.2639|0.2609|0.4609
91751687|NCT00909545|183396238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.8065|0.1109|0.7852
91751688|NCT00909545|183396238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||3.1612|0.0297|0.9448
91751689|NCT00909545|183396238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.697|STANDARD_ERROR_OF_MEAN|0.9604||0.7996|TWO_SIDED|95.0|0.1061|4.5779|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.5779|0.1061|0.7996
91751690|NCT00909545|183396239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.381|STANDARD_ERROR_OF_MEAN|1.2599||0.4532|TWO_SIDED|95.0|0.2015|28.1366|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||28.1366|0.2015|0.4532
91751691|NCT00909545|183396239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9524|STANDARD_ERROR_OF_MEAN|1.1347||0.0953|TWO_SIDED|95.0|0.6439|55.0272|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||55.0272|0.6439|0.0953
91751692|NCT00909545|183396240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402||95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||11.8558|0.2733|0.4402
91751693|NCT00909545|183396240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||5.6461|0.0408|0.8824
91751694|NCT00909545|183396240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0909|STANDARD_ERROR_OF_MEAN|1.0428||0.6641|TWO_SIDED|95.0|0.1413|8.4197|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||8.4197|0.1413|0.6641
91751695|NCT00909545|183396241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||11.8558|0.2733|0.4402
91751696|NCT00909545|183396241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||7.6906|0.1300|0.6951
91751697|NCT00909545|183396242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||11.8558|0.2733|0.4402
91751698|NCT00909545|183396242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||5.6461|0.0408|0.8824
91751699|NCT00909545|183396242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||6.1537|0.0442|0.8673
91751700|NCT00909545|183396243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3485|STANDARD_ERROR_OF_MEAN|1.1919||0.9294|TWO_SIDED|95.0|0.0337|3.6084|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.6084|0.0337|0.9294
91751701|NCT00909545|183396243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.1612|0.0297|0.9448
91751702|NCT00909545|183396243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3333|STANDARD_ERROR_OF_MEAN|1.1924||0.9351|TWO_SIDED|95.0|0.0322|3.4459|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.4459|0.0322|0.9351
91751703|NCT00909545|183396244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.4433|0.0462|0.8589
91751704|NCT00909545|183396244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||7.6906|0.1300|0.6951
91506657|NCT03034954|182884128|OTHER|||||||0.3|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.3
91532355|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.9|TWO_SIDED|95.0|-6.98|7.92|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Lesional||7.92|-6.98|0.900
91751705|NCT00909545|183396244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.1537|0.0442|0.8673
91751706|NCT00909545|183396245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||4.8065|0.1109|0.7852
91751707|NCT00909545|183396245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||3.1612|0.0297|0.9448
91751708|NCT00909545|183396246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||24.5057|0.1771|0.5000
91751709|NCT00909545|183396246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5714|STANDARD_ERROR_OF_MEAN|1.192||0.2746|TWO_SIDED|95.0|0.3453|36.9408|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||36.9408|0.3453|0.2746
91751710|NCT00909545|183396247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1364|STANDARD_ERROR_OF_MEAN|1.4444||0.7236|TWO_SIDED|95.0|0.067|19.264|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||19.2640|0.0670|0.7236
91751711|NCT00909545|183396247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||24.5057|0.1771|0.5000
91751712|NCT00909545|183396247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2727|STANDARD_ERROR_OF_MEAN|1.2592||0.4694|TWO_SIDED|95.0|0.1926|26.8124|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||26.8124|0.1926|0.4694
91751713|NCT04612842|183396248|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91506658|NCT03034954|182884133|OTHER|||||||0.45|||||||MANOVA|||A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').||||.450
91506659|NCT03034954|182884134|OTHER|||||||0.078|||||||Chi-squared|||Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition||||.078
91506660|NCT03034954|182884135|OTHER|||||||0.233|||||||Fisher Exact|||||||.233
91532356|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-5.97||||0.13|TWO_SIDED|95.0|-13.76|1.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Lesional||1.82|-13.76|0.130
91751714|NCT03060512|183396265|OTHER|||||||0.9239|||||||Prescott's test|||Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.||||0.9239
91751715|NCT03060512|183396265|OTHER|||||||0.8874|||||||Prescott's test|||Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preference||||0.8874
91751716|NCT03060512|183396268|OTHER||Least Squares (LS) Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.3|0.3||||||Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.||0.3|-0.3|
91751717|NCT03060512|183396270|OTHER||LS Means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-4.7|3.0||||||Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.||3.0|-4.7|
91751718|NCT00089986|183396271|SUPERIORITY_OR_OTHER||Rate difference|1.1||||0.329|ONE_SIDED|90.0|-2.1||||Chi-squared||||||-2.1|0.329
91751719|NCT00089986|183396271|SUPERIORITY_OR_OTHER||Rate Difference|-4.4||||0.879|ONE_SIDED|90.0|-9.4||||Chi-squared||||||-9.4|0.879
91751720|NCT01310400|183396275|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|4.5||||0.0036|TWO_SIDED|95.0|1.4|7.5||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||7.5|1.4|0.0036
91506661|NCT03034954|182884137|OTHER|||||||0.6|||||||Fisher Exact|||||||.600
91506662|NCT03034954|182884138|OTHER|||||||0.999|||||||Fisher Exact|||||||.999
91506663|NCT03034954|182884139|OTHER|||||||0.281|||||||Fisher Exact|||||||.281
91506664|NCT03034954|182884140|OTHER|||||||0.082|||||||Fisher Exact|||||||.082
91532357|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.069|TWO_SIDED|95.0|-14.76|0.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Lesional||0.56|-14.76|0.069
91506665|NCT03034954|182884141|OTHER|||||||0.49|||||||Fisher Exact|||||||.490
91751721|NCT01310400|183396275|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|-3.0||||0.1465|TWO_SIDED|95.0|-7.0|1.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||1.0|-7.0|0.1465
91751722|NCT01310400|183396275|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|8.0|||<|0.001|TWO_SIDED|95.0|3.3|12.7||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||12.7|3.3|<0.001
91751723|NCT01310400|183396275|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|0.9||||0.7493|TWO_SIDED|95.0|-4.5|6.2||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||6.2|-4.5|0.7493
91506666|NCT03034954|182884142|OTHER|||||||0.488|||||||Fisher Exact|||||||.488
91506667|NCT03034954|182884143|OTHER|||||||0.219|||||||Fisher Exact|||||||.219
91506668|NCT00913744|182884214|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.262|TWO_SIDED|95.0|-3.7|28.4|||Fisher Exact|P-value is from Fisher's exact test, comparing sham and ocriplasmin.||||28.4|-3.7|0.262
91506669|NCT00805935|182884215|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.000
91506670|NCT00805935|182884215|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
91506671|NCT00805935|182884215|SUPERIORITY_OR_OTHER|||||||0.481||95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.||||0.481
91506672|NCT00805935|182884215|SUPERIORITY_OR_OTHER|||||||0.483|TWO_SIDED|95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.||||0.483
91506673|NCT01218516|182884229|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.3519|TWO_SIDED|80.0|0.92|1.63||Per Primary Analysis Cut-Off Date|Log Rank|||||1.63|0.92|0.3519
91506674|NCT01218516|182884229|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.34||||0.1555|TWO_SIDED|80.0|1.03|1.74||Per Final Analysis Cut-Off Date|Log Rank|||||1.74|1.03|0.1555
91506675|NCT00283439|182884234|SUPERIORITY_OR_OTHER|||||||0.9654||||||One-sided test|Satterhwaite t-test|||||||0.9654
91506676|NCT00283439|182884234|SUPERIORITY_OR_OTHER|||||||0.869||||||One-sided test|Satterhwaite t-test|||||||0.8690
91506677|NCT00283439|182884234|SUPERIORITY_OR_OTHER|||||||0.7133||||||One-sided test|Satterhwaite t-test|||||||0.7133
91506678|NCT00283439|182884235|SUPERIORITY_OR_OTHER|||||||0.294|||||||Fisher Exact|||||||0.294
91506679|NCT00283439|182884235|SUPERIORITY_OR_OTHER|||||||0.608|||||||Fisher Exact|||||||0.608
91506680|NCT00283439|182884235|SUPERIORITY_OR_OTHER|||||||0.603|||||||Fisher Exact|||||||0.603
91506681|NCT00283439|182884236|SUPERIORITY_OR_OTHER|||||||0.091|||||||Satterhwaite t-test|||||||0.091
91532358|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.032|TWO_SIDED|95.0|-15.25|-0.73|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Lesional||-0.73|-15.25|0.032
91506682|NCT00283439|182884236|SUPERIORITY_OR_OTHER|||||||0.3|||||||Satterhwaite t-test|||||||0.300
91506683|NCT00283439|182884236|SUPERIORITY_OR_OTHER|||||||0.881|||||||Satterhwaite t-test|||||||0.881
91506684|NCT00283439|182884237|SUPERIORITY_OR_OTHER|||||||0.576|||||||Fisher Exact|||||||0.576
91506685|NCT00283439|182884237|SUPERIORITY_OR_OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
91506686|NCT00283439|182884237|SUPERIORITY_OR_OTHER|||||||0.421|||||||Fisher Exact|||||||0.421
91506687|NCT01632891|182884246|SUPERIORITY|Test used alpha level of 0.05||||||1|||||||Fisher Exact|||Compare proportions of Pf SCP clearance between treatment arms||||1.00
91506688|NCT02121483|182884292|SUPERIORITY_OR_OTHER||Slope|0.949|STANDARD_ERROR_OF_MEAN|0.1075|||TWO_SIDED|95.0|0.7276|1.1704|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% confidence interval (CI) for the slope was computed.|||1.1704|0.7276|
91506689|NCT02121483|182884293|SUPERIORITY_OR_OTHER||Slope|0.9597|STANDARD_ERROR_OF_MEAN|0.1088|||TWO_SIDED|95.0|0.7356|1.1838|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1838|0.7356|
91506690|NCT02121483|182884294|SUPERIORITY_OR_OTHER||Slope|0.8554|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.5504|1.1603|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1603|0.5504|
91506691|NCT05583903|182884305|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91506692|NCT05583903|182884306|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
91506693|NCT05583903|182884307|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91506694|NCT05583903|182884308|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91532359|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.803|TWO_SIDED|95.0|-9.37|7.28|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||7.28|-9.37|0.803
91506695|NCT05583903|182884309|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91506696|NCT05583903|182884310|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
91506697|NCT05583903|182884311|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
91506698|NCT05583903|182884312|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91506699|NCT05583903|182884313|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
91506700|NCT05583903|182884314|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
91506701|NCT05583903|182884315|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91506702|NCT05583903|182884316|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
91506703|NCT05583903|182884317|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
91532360|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.972|TWO_SIDED|95.0|-9.02|9.34|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Lesional||9.34|-9.02|0.972
91506704|NCT05583903|182884318|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
91506705|NCT05583903|182884319|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91506706|NCT01094548|182884366|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
91506707|NCT01094548|182884370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.431||||0.094|TWO_SIDED|95.0|0.157|1.185|||Log Rank|||||1.185|0.157|0.0940
91506708|NCT01094548|182884371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.3919|TWO_SIDED|95.0|0.261|1.698|||Log Rank|||||1.698|0.261|0.3919
91506709|NCT01073865|182884406|NON_INFERIORITY_OR_EQUIVALENCE|The lower limit of the CI of the difference is greater than or equal to -17.5%. This non-inferiority margin was pre-defined in the study protocol.|Risk Difference (RD)|1.29|||||TWO_SIDED|95.0|-11.4|13.9|||||%PFS at 24 weeks for Zoladex 10.8mg - %PFS at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al||13.90|-11.40|
91506710|NCT01073865|182884407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.02|||||TWO_SIDED|95.0|-15.47|9.67|||||ORR at 24 weeks for Zoladex 10.8mg - ORR at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al||9.67|-15.47|
91506711|NCT00680901|182884451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3492|TWO_SIDED|95.0|0.73|1.12||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (PE population)||1.12|0.73|0.3492
91506712|NCT00680901|182884452|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3244|TWO_SIDED|95.0|0.74|1.1||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (ITT population)||1.10|0.74|0.3244
91506713|NCT00847288|182884468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.0043|TWO_SIDED|95.0|1.1|2.0||Cox proportional hazard model was fitted with the group effect and other key baseline variables. The p-value for the main group effect is 0.0043, with an estimated hazard ratio of 1.5, monthly vs quarterly.|Regression, Cox|||"Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio."||2.0|1.1|0.0043
91506714|NCT00847288|182884470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0001|TWO_SIDED|95.0|1.2|1.74|||logistic GEE for repeated observations|||The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.||1.74|1.20|0.0001
91506715|NCT02120794|182884474|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.125|0.395||||||||0.395|0.125|
91506716|NCT00500370|182884544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
91506717|NCT00500370|182884545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
91506718|NCT00500370|182884546|SUPERIORITY_OR_OTHER|||||||0.6766||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.6766
91506719|NCT00500370|182884547|SUPERIORITY_OR_OTHER|||||||0.0393||95.0|||||Cochran-Mantel-Haenszel|||||||0.0393
91506720|NCT00500370|182884548|SUPERIORITY_OR_OTHER|||||||0.1808||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1808
91506721|NCT00500370|182884549|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
91506722|NCT00500370|182884550|SUPERIORITY_OR_OTHER|||||||0.6651||95.0|||||ANCOVA|||||||0.6651
91506723|NCT00500370|182884551|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
91506724|NCT00500370|182884552|SUPERIORITY_OR_OTHER|||||||0.8479||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.8479
91506725|NCT00500370|182884553|SUPERIORITY_OR_OTHER|||||||0.2151||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2151
91506726|NCT00500370|182884554|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||ANCOVA|||||||0.7619
91506727|NCT00500370|182884555|SUPERIORITY_OR_OTHER|||||||0.8973||95.0|||||ANCOVA|||||||0.8973
91506728|NCT00500370|182884556|SUPERIORITY_OR_OTHER|||||||0.6507||95.0|||||Cochran-Mantel-Haenszel|||||||0.6507
91506729|NCT00500370|182884557|SUPERIORITY_OR_OTHER|||||||0.2593||95.0|||||Cochran-Mantel-Haenszel|||||||0.2593
91506730|NCT00500370|182884558|SUPERIORITY_OR_OTHER|||||||0.2919||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2919
91506731|NCT00500370|182884559|SUPERIORITY_OR_OTHER|||||||0.0293||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.0293
91506732|NCT02586012|182884567|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91506733|NCT02586012|182884568|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91506734|NCT02586012|182884569|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91506735|NCT01888497|182884643|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|13.82|||<|0.001|TWO_SIDED|95.0|10.85|17.4||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam versus (vs) placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||17.40|10.85|<0.001
91506736|NCT01888497|182884643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95 percent (%) confidence interval (CI) was 2.4 cm.|Hodges-Lehman estimate|0.55|||||TWO_SIDED|95.0|-0.66|2.33|||||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.33|-0.66|
91506737|NCT01888497|182884643|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|1.02||||0.134|TWO_SIDED|95.0|-0.39|2.51||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.51|-0.39|0.134
91532361|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.933|TWO_SIDED|95.0|-6.66|6.12|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||6.12|-6.66|0.933
91532362|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.563|TWO_SIDED|95.0|-8.1|4.45|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||4.45|-8.10|0.563
91532363|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-7.08||||0.075|TWO_SIDED|95.0|-14.88|0.73|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||0.73|-14.88|0.075
91532364|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-9.84||||0.01|TWO_SIDED|95.0|-17.19|-2.48|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||-2.48|-17.19|0.010
91532365|NCT03389893|182941356|SUPERIORITY||Median Difference (Final Values)|0.69||||0.805|TWO_SIDED|95.0|-4.86|6.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 3, Non-lesional||6.23|-4.86|0.805
91532366|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|2.36||||0.329|TWO_SIDED|95.0|-2.44|7.15|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Non-lesional||7.15|-2.44|0.329
91532367|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-5.39|5.6|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Non-lesional||5.60|-5.39|0.970
91532368|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.18|TWO_SIDED|95.0|-8.18|1.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Non-lesional||1.56|-8.18|0.180
91751724|NCT01310400|183396275|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|20.2||||0|TWO_SIDED|95.0|13.5|27.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||27.0|13.5|0.0000
91751725|NCT01310400|183396275|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|10.7||||0.0029|TWO_SIDED|95.0|3.7|17.6||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||17.6|3.7|0.0029
91751726|NCT04065074|183396279|OTHER|Proportion of Successful Administrations|Proportion of Successful Administrations|0.75|||||TWO_SIDED|90.0|0.51|0.9||||||||0.90|0.51|
91751727|NCT01062841|183396283|SUPERIORITY_OR_OTHER||Rate Ratio|0.77|||<|0.05|TWO_SIDED|95.0|0.62|0.94||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.94|0.62|<0.05
91751728|NCT01062841|183396284|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.54||||0.04|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||0.97|0.30|0.04
91751729|NCT01062841|183396285|SUPERIORITY_OR_OTHER||Rate Ratio|0.78|||<|0.05|TWO_SIDED|95.0|0.64|0.96||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.96|0.64|<0.05
91506738|NCT01888497|182884643|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|2.37|||<|0.001|TWO_SIDED|95.0|1.01|3.98||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||3.98|1.01|<0.001
91532369|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.342|TWO_SIDED|95.0|-5.45|1.94|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Non-lesional||1.94|-5.45|0.342
91532370|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-2.17||||0.234|TWO_SIDED|95.0|-5.81|1.47|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Non-lesional||1.47|-5.81|0.234
91532371|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.316|TWO_SIDED|95.0|-6.27|2.07|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Non-lesional||2.07|-6.27|0.316
91532372|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-1.89||||0.276|TWO_SIDED|95.0|-5.37|1.59|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Non-lesional||1.59|-5.37|0.276
91532373|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.237|TWO_SIDED|95.0|-4.19|1.06|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||1.06|-4.19|0.237
91532374|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-3.03||||0.01|TWO_SIDED|95.0|-5.3|-0.77|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||-0.77|-5.30|0.010
91532375|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.77|TWO_SIDED|95.0|-3.57|2.65|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||2.65|-3.57|0.770
91532376|NCT03389893|182941356|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.117|TWO_SIDED|95.0|-4.84|0.56|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||0.56|-4.84|0.117
91532377|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|85.05||||0.085|TWO_SIDED|95.0|-12.02|182.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||182.12|-12.02|0.085
91532378|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-21.91||||0.733|TWO_SIDED|95.0|-149.13|105.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||105.32|-149.13|0.733
91751730|NCT01062841|183396286|SUPERIORITY_OR_OTHER||Rate Ratio|1.2|||>|0.05|TWO_SIDED|95.0|0.82|1.75||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.75|0.82|>0.05
91751731|NCT01062841|183396287|SUPERIORITY_OR_OTHER||Rate Ratio|0.94|||>|0.05|TWO_SIDED|95.0|0.61|1.44||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.44|0.61|>0.05
91751732|NCT01062841|183396288|SUPERIORITY_OR_OTHER||Rate Ratio|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.97||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.97|0.58|<0.05
91751733|NCT01062841|183396290|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.09||||0.92|TWO_SIDED|95.0|0.22|5.45|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||5.45|0.22|0.92
91751734|NCT01062841|183396291|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.83||||0.34|TWO_SIDED|95.0|0.53|6.31|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||6.31|0.53|0.34
91751735|NCT01062841|183396292|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.01|TWO_SIDED|95.0|0.65|0.95|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||0.95|0.65|0.01
91751736|NCT01062841|183396293|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85||||0.61|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||1.60|0.45|0.61
91751737|NCT01062841|183396294|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.59|TWO_SIDED|95.0|0.6|1.33|||Regression, Cox|||||1.33|0.60|0.59
91506739|NCT01888497|182884644|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.47||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.47|0.26|<0.001
91506740|NCT01888497|182884644|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 0.1 m/sec.|Hodges-Lehman estimate|-0.01|||||TWO_SIDED|95.0|-0.07|0.05|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.05|-0.07|
91506741|NCT01888497|182884644|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.07||||0.012|TWO_SIDED|95.0|0.02|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.02|0.012
91506742|NCT01888497|182884644|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.06||||0.014|TWO_SIDED|95.0|0.01|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.01|0.014
91532379|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-82.5||||0.129|TWO_SIDED|95.0|-189.6|24.61|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||24.61|-189.60|0.129
91751738|NCT03831880|183396301|SUPERIORITY||Mean Difference (Final Values)|-15.49|||<|0.0001|TWO_SIDED|95.0|-19.71|-11.27||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-11.27|-19.71|<0.0001
91751739|NCT03831880|183396303|SUPERIORITY||Mean Difference (Final Values)|-5.39||||0.0017|TWO_SIDED|95.0|-8.69|-2.09||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-2.09|-8.69|0.0017
91751740|NCT03831880|183396305|SUPERIORITY||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-19.74|-7.45||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-7.45|-19.74|<0.0001
91751741|NCT03831880|183396307|SUPERIORITY||Mean Difference (Final Values)|-24.34|||<|0.0001|TWO_SIDED|95.0|-30.1|-18.57||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-18.57|-30.10|<0.0001
91506743|NCT01888497|182884645|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|103.25|||<|0.001|TWO_SIDED|95.0|72.0|130.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||130.50|72.00|<0.001
91506744|NCT01888497|182884645|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 8 lanes.|Hodges-Lehman estimate|5.0|||||TWO_SIDED|95.0|-4.0|16.5|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||16.50|-4.00|
91506745|NCT01888497|182884645|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|3.0||||0.213|TWO_SIDED|95.0|-3.0|9.0||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||9.00|-3.00|0.213
91532380|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-92.11||||0.057|TWO_SIDED|95.0|-187.11|2.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||2.89|-187.11|0.057
91751742|NCT03831880|183396309|SUPERIORITY||Mean Difference (Final Values)|-7.83||||0.0739|TWO_SIDED|95.0|-16.42|0.77||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||0.77|-16.42|0.0739
91751743|NCT03831880|183396311|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.0001|TWO_SIDED|95.0|-25.15|-10.06||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.06|-25.15|<0.0001
91506746|NCT01888497|182884645|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|11.0||||0.003|TWO_SIDED|95.0|4.0|20.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||20.50|4.00|0.003
91532381|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-48.76||||0.242|TWO_SIDED|95.0|-131.52|34.0|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||34.00|-131.52|0.242
91532382|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-54.37||||0.262|TWO_SIDED|95.0|-150.24|41.49|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||41.49|-150.24|0.262
91532383|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-22.97||||0.546|TWO_SIDED|95.0|-99.79|53.86|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||53.86|-99.79|0.546
91751744|NCT03831880|183396313|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.6137|TWO_SIDED|95.0|-2.09|3.51||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||3.51|-2.09|0.6137
91751745|NCT03831880|183396315|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.8404|TWO_SIDED|95.0|-5.29|6.41||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||6.41|-5.29|0.8404
91751746|NCT03831880|183396317|SUPERIORITY||Mean Difference (Final Values)|-13.47|||<|0.0001|TWO_SIDED|95.0|-17.59|-9.35||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-9.35|-17.59|<0.0001
91751747|NCT03831880|183396319|SUPERIORITY||Mean Difference (Final Values)|-2.76||||0.0245|TWO_SIDED|95.0|-5.16|-0.36||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-0.36|-5.16|0.0245
91751748|NCT03831880|183396331|SUPERIORITY||Mean Difference (Final Values)|-14.58|||<|0.0001|TWO_SIDED|95.0|-18.72|-10.44||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.44|-18.72|<0.0001
91532384|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.503|TWO_SIDED|95.0|-86.34|42.75|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||42.75|-86.34|0.503
91751749|NCT02081638|183396338|OTHER||||||>|0.05||||||Threshold for statistical significance was a priori set to \<0.05|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||>0.05
91751750|NCT02081638|183396338|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.022
91751751|NCT02081638|183396339|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.13
91751752|NCT02081638|183396339|OTHER|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.097
91751753|NCT02081638|183396339|OTHER|||||||0.0269|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.0269
91506747|NCT04127786|182884698|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95 percent (%) confidence interval (CI) of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was greater than (\>) -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
91532385|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-64.0||||0.034|TWO_SIDED|95.0|-123.01|-4.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-4.98|-123.01|0.034
91532386|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-10.29||||0.789|TWO_SIDED|95.0|-86.63|66.04|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||66.04|-86.63|0.789
91532387|NCT03389893|182941357|SUPERIORITY||Mean Difference (Final Values)|-83.9||||0.014|TWO_SIDED|95.0|-149.82|-17.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-17.98|-149.82|0.014
91751754|NCT02081638|183396339|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
91751755|NCT02081638|183396339|OTHER||||||||||||||||||Plasma biomarkers (CRP, sCD14, TF, IL-6) were log(e) transformed and a linear mixed effect model with the biomarker as outcome and with random slope per participant was used to calculate the percentage of change from baseline.|||
91751756|NCT01414205|183396347|SUPERIORITY_OR_OTHER||Difference (Hauck-Anderson)|17.89||||0.0779|TWO_SIDED|95.0|-4.95|40.72|||Cochran-Mantel-Haenszel|P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.||||40.72|-4.95|0.0779
91751757|NCT02498067|183396386|OTHER|||||||0.177||||||a priori threshold for statistical significance: p\<0.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.177
91751758|NCT02498067|183396387|OTHER|||||||0.318||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.318
91506748|NCT04127786|182884698|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|1.2|||||TWO_SIDED|95.0|-0.6|6.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (\>=18 years)||6.4|-0.6|
91532388|NCT03389893|182941358|SUPERIORITY||Slope|-0.07||||0.86|TWO_SIDED|95.0|-0.92|0.77|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||0.77|-0.92|0.860
91532389|NCT03389893|182941358|SUPERIORITY||Slope|-0.22||||0.488|TWO_SIDED|95.0|-0.85|0.41|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||0.41|-0.85|0.488
91751759|NCT02498067|183396388|OTHER|||||||0||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.000
91751760|NCT02498067|183396390|OTHER|||||||0.03||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.030
91751761|NCT02498067|183396391|OTHER|||||||0.14||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.140
91751762|NCT02498067|183396392|OTHER|||||||0.315||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.315
91751763|NCT02498067|183396393|OTHER|||||||0.028||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.028
91751764|NCT02498067|183396394|OTHER|||||||0.918||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.918
91751765|NCT02498067|183396396|OTHER|||||||0.209||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-up||||.209
91751766|NCT02498067|183396397|OTHER|||||||0.652||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.652
91751767|NCT02498067|183396398|OTHER|||||||0.498||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.498
91751768|NCT02498067|183396399|OTHER|||||||0.977||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.977
91751769|NCT02498067|183396400|OTHER|||||||0.673||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.673
91751770|NCT02498067|183396401|OTHER|||||||0.049||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.049
91751771|NCT02498067|183396401|OTHER|||||||0.265||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.265
91751772|NCT01874275|183396404|SUPERIORITY_OR_OTHER|||||||0.2413|TWO_SIDED||||||Mixed Models Analysis|||||||0.2413
91751773|NCT02214225|183396410|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.92|||||TWO_SIDED|95.0|0.87|0.98||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.87|
91506749|NCT04127786|182884698|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (\< 18 years)||4.4|-1.4|
91532390|NCT03389893|182941358|SUPERIORITY||Slope|-0.55||||0.144|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||0.20|-1.30|0.144
91506750|NCT04127786|182884698|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.5|4.6||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (\>= 18 years)||4.6|-1.5|
91506751|NCT04127786|182884699|SUPERIORITY|If the non-inferiority for VRVg-2 versus comparator vaccines was reached at Day 42, then superiority was demonstrated if the overall observed percentage of participants with an RVNA titer \>= 0.5 IU/mL at Day 42 was at least 99% in the VRVg-2 Group, with the lower limit of the 95% CI at least 97%.|Percentage Difference|100.0|||||TWO_SIDED|95.0|99.3|100.0||||||The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.||100|99.3|
91751774|NCT02214225|183396410|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.93|||||TWO_SIDED|95.0|0.88|0.98||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.88|
91751775|NCT02214225|183396410|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.87|||||TWO_SIDED|95.0|0.81|0.93||||||For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.93|0.81|
91751776|NCT02214225|183396410|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.94|||||TWO_SIDED|95.0|0.86|1.01||||||For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.01|0.86|
91751777|NCT02214225|183396411|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-1.1|||||TWO_SIDED|95.0|-4.4|2.2||||||||2.2|-4.4|
91751778|NCT02214225|183396411|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-1.7|||||TWO_SIDED|95.0|-5.0|1.6||||||||1.6|-5.0|
91751779|NCT02214225|183396411|NON_INFERIORITY_OR_EQUIVALENCE|For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-3.2|||||TWO_SIDED|95.0|-7.0|0.5||||||||0.5|-7.0|
91751780|NCT02214225|183396411|NON_INFERIORITY_OR_EQUIVALENCE|For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-1.6|||||TWO_SIDED|95.0|-5.6|2.4||||||||2.4|-5.6|
91751781|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.85|
91751782|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.91|||||TWO_SIDED|95.0|0.83|0.99||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.99|0.83|
91751783|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.86|||||TWO_SIDED|95.0|0.76|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.76|
91751784|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.86|||||TWO_SIDED|95.0|0.76|0.98||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.76|
91751785|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.95|||||TWO_SIDED|95.0|0.88|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.88|
91506752|NCT04127786|182884700|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
91506753|NCT04127786|182884700|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.9|2.7||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (\>=18 years)||2.7|-1.9|
91506754|NCT04127786|182884700|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.5||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (\< 18 years)||4.5|-1.4|
91506755|NCT04127786|182884700|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.5|5.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (\>= 18 years)||5.3|-0.5|
91506756|NCT04127786|182884701|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (\< 18 years)||4.4|-1.4|
91506757|NCT04127786|182884701|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|-1.7|||||TWO_SIDED|95.0|-3.1|3.0|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (\>= 18 years)||3.0|-3.1|
91532391|NCT03389893|182941358|SUPERIORITY||Slope|-0.35||||0.279|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||0.30|-1.00|0.279
91532392|NCT03389893|182941358|SUPERIORITY||Slope|-0.29||||0.461|TWO_SIDED|95.0|-1.09|0.5|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||0.50|-1.09|0.461
91506758|NCT04127786|182884703|NON_INFERIORITY|If the superiority objective of VRVg-2 was reached at Day 28, the non-inferiority of 2-dose Imovax Rabies® at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the 2-dose Imovax Rabies® at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Percentage Difference|-1.3|||||TWO_SIDED|95.0|-4.4|1.3||||||Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 42||1.3|-4.4|
91506759|NCT01904604|182884728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|33.8||||0.005|TWO_SIDED|33.8|10.2|57.5||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||57.5|10.2|0.005
91506760|NCT01904604|182884728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.0||||0.003|TWO_SIDED|36.0|12.6|59.4||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||59.4|12.6|0.003
91506761|NCT01904604|182884728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.2||||0.48|TWO_SIDED|2.2|-25.8|30.1||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||||30.1|-25.8|0.48
91506762|NCT01904604|182884732|SUPERIORITY_OR_OTHER|||||||0.8||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.80
91506763|NCT01904604|182884732|SUPERIORITY_OR_OTHER|||||||0.008||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.008
91506764|NCT01904604|182884732|SUPERIORITY_OR_OTHER|||||||0.01||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.01
91532393|NCT03389893|182941358|SUPERIORITY||Slope|-0.27||||0.345|TWO_SIDED|95.0|-0.84|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||0.30|-0.84|0.345
91532394|NCT03389893|182941358|SUPERIORITY||Slope|-0.27||||0.275|TWO_SIDED|95.0|-0.77|0.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||0.23|-0.77|0.275
91532395|NCT00958009|182941386|SUPERIORITY_OR_OTHER||mean positive response|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is \>0.50.|||0.93|0.80|
91506765|NCT05124665|182884736|EQUIVALENCE|Hypothesis is that proportion of contacts accepting HIV testing between two study arms is equivalent.|Odds Ratio (OR)|4.6||||0.004|TWO_SIDED|95.0|1.6|12.9|||Mixed Models Analysis|Cluster adjusted for household.||||12.9|1.6|0.004
91506766|NCT05124665|182884736|EQUIVALENCE|Hypothesis is proportion of contacts accepting HIV testing is equivalent between the two study arms|Mean Difference (Net)|6.0||||0.006|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided||Estimated value and confidence interval reflects the values multiplied by 100 (converting decimal to percentage).|||10|2|0.006
91506767|NCT05124665|182884737|EQUIVALENCE|Hypothesis is that the change in stigma score is equivalent between the two study arms.|Slope|2.2||||0.358|TWO_SIDED|95.0|-2.5|6.9|||Mixed Models Analysis|||Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale)||6.9|-2.5|0.358
91506768|NCT05124665|182884738|EQUIVALENCE|Hypothesis is that the difference in stigma score is equivalent between the two study arms|Slope|2.61||||0.199|TWO_SIDED|95.0|-1.38|6.59|||Mixed Models Analysis|||||6.59|-1.38|0.199
91506769|NCT05124665|182884739|EQUIVALENCE|Hypothesis is no effect from perceived HIV Stigma on HIV Test Uptake|Coefficient from Structural Equation|0.00087||||0.03|TWO_SIDED|95.0|0.00007|0.00167|||Structural Equation Modeling|||||0.00167|0.00007|0.03
91506770|NCT05124665|182884740|EQUIVALENCE|Hypothesis is that TB stigma has no effect of HIV test uptake|Coefficient Structural Equation Model|0.0002||||0.64|TWO_SIDED|95.0|-0.0007|0.0011|||Structural Equation Modeling|||||0.0011|-0.0007|0.64
91506771|NCT05124665|182884741|EQUIVALENCE|Hypothesis is that proportion of index patient nominated household contacts accepting HIV testing is equivalent between two study arms||||||0.452|||||||Chi-squared|||||||0.452
91506772|NCT05124665|182884742|NON_INFERIORITY|Hypothesis is that the first tester's decision to test does not impact subsequent household contacts decision to test for HIV.|Risk Ratio (RR)|1.23||||0.264|TWO_SIDED|95.0|0.86|1.76|||Regression, Logistic|||||1.76|0.86|0.264
91506773|NCT05124665|182884743|EQUIVALENCE|Hypothesis is that the index patient and contact nominations will match equally regardless of study arm.|||||<|0.001|||||||Chi-squared|||||||<0.001
91506774|NCT02904057|182884753|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Imputed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with confidence interval (CI) was calculated using an exact approach.||98.8|73.4|<0.0001
91506775|NCT02904057|182884753|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Observed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with CI was calculated using an exact approach.||98.8|73.4|<0.0001
91506776|NCT02633956|182884777|OTHER|Estimation|Least Square Mean Difference|13.79|STANDARD_ERROR_OF_MEAN|5.75|||TWO_SIDED|95.0|2.28|25.3||||||||25.30|2.28|
91506777|NCT02633956|182884777|OTHER|Estimation|Least Square Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|5.61|||TWO_SIDED|95.0|-2.18|20.3||||||||20.30|-2.18|
91506778|NCT02633956|182884777|OTHER|Estimation|Least Square Mean Difference|20.13|STANDARD_ERROR_OF_MEAN|6.39|||TWO_SIDED|95.0|7.33|32.92||||||||32.92|7.33|
91506779|NCT02633956|182884778|OTHER|Estimation|Least Square Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.07|0.75||||||||0.75|0.07|
91506780|NCT02633956|182884778|OTHER|Estimation|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.25|0.42||||||||0.42|-0.25|
91506781|NCT02633956|182884778|OTHER|Estimation|Least Square Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.14|0.89||||||||0.89|0.14|
91506782|NCT02633956|182884779|OTHER|Estimation|Least Square Mean Difference|103.61|STANDARD_ERROR_OF_MEAN|69.51|||TWO_SIDED|95.0|-35.58|242.81||||||||242.81|-35.58|
91506783|NCT02633956|182884779|OTHER|Estimation|Least Square Mean Difference|114.8|STANDARD_ERROR_OF_MEAN|68.08|||TWO_SIDED|95.0|-21.53|251.13||||||||251.13|-21.53|
91506784|NCT02633956|182884779|OTHER|Estimation|Least Square Mean Difference|215.05|STANDARD_ERROR_OF_MEAN|79.51|||TWO_SIDED|95.0|55.84|374.26||||||||374.26|55.84|
91506785|NCT04206293|182884785|SUPERIORITY||Least Squares (LS) Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.9||0.0736|TWO_SIDED|95.0|-0.2|3.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||3.6|-0.2|0.0736
91506786|NCT04206293|182884785|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.0||0.5259|TWO_SIDED|95.0|-1.5|2.8|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||2.8|-1.5|0.5259
91506787|NCT04206293|182884786|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8848|TWO_SIDED|95.0|-2.8|2.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||2.4|-2.8|0.8848
91506788|NCT04206293|182884786|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9505|TWO_SIDED|95.0|-1.8|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-1.8|0.9505
91506789|NCT04206293|182884787|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.6||0.0007|TWO_SIDED|95.0|1.4|4.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.0|1.4|0.0007
91506790|NCT04206293|182884787|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0033|TWO_SIDED|95.0|0.9|3.9|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||3.9|0.9|0.0033
91506791|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.095|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.119|-0.07|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 28||-0.070|-0.119|<0.0001
91506792|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.071|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.094|-0.048|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 84||-0.048|-0.094|<0.0001
91506793|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.116|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 28||-0.061|-0.116|<0.0001
91506794|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|-0.102|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 84||-0.061|-0.102|<0.0001
91506795|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.018||0.0003||95.0|-0.116|-0.041|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 28||-0.041|-0.116|0.0003
91506796|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|-0.103|-0.044|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 84||-0.044|-0.103|0.0001
91506797|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.017||0.0002|TWO_SIDED|95.0|-0.117|-0.045|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 28||-0.045|-0.117|0.0002
91506798|NCT04206293|182884788|SUPERIORITY||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.103|-0.052|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 84||-0.052|-0.103|<0.0001
91506799|NCT04206293|182884789|SUPERIORITY||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.014||0.5786|TWO_SIDED|95.0|-0.038|0.022|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 28||0.022|-0.038|0.5786
91506800|NCT04206293|182884789|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.012||0.069|TWO_SIDED|95.0|-0.049|0.002|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 84||0.002|-0.049|0.0690
91506801|NCT04206293|182884789|SUPERIORITY||LS Mean Difference|-0.021|STANDARD_ERROR_OF_MEAN|0.016||0.1934|TWO_SIDED|95.0|-0.054|0.012|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 28||0.012|-0.054|0.1934
91506802|NCT04206293|182884789|SUPERIORITY||LS Mean Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0194|TWO_SIDED|95.0|-0.062|-0.006|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 84||-0.006|-0.062|0.0194
91506803|NCT04206293|182884789|SUPERIORITY||LS Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.007||0.0652|TWO_SIDED|95.0|-0.001|0.028|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 28||0.028|-0.001|0.0652
91506804|NCT04206293|182884789|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.006||0.0756|TWO_SIDED|95.0|-0.001|0.024|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 84||0.024|-0.001|0.0756
91506805|NCT04206293|182884790|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.68||0.8409|TWO_SIDED|95.0|-6.19|5.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||5.10|-6.19|0.8409
91506806|NCT04206293|182884790|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|3.98||0.9183|TWO_SIDED|95.0|-9.18|8.35|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||8.35|-9.18|0.9183
91506807|NCT04206293|182884791|SUPERIORITY||LS Mean Difference|70.0|STANDARD_ERROR_OF_MEAN|77.0||0.4128|TWO_SIDED|95.0|-142.0|282.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||282|-142|0.4128
91506808|NCT04206293|182884791|SUPERIORITY||LS Mean Difference|-82.0|STANDARD_ERROR_OF_MEAN|79.0||0.3851|TWO_SIDED|95.0|-355.0|191.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||191|-355|0.3851
91506809|NCT04206293|182884792|SUPERIORITY||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|3.44||0.0798|TWO_SIDED|95.0|-0.89|13.93|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||13.93|-0.89|0.0798
91506810|NCT04206293|182884792|SUPERIORITY||LS Mean Difference|5.56|STANDARD_ERROR_OF_MEAN|3.27||0.1142|TWO_SIDED|95.0|-1.55|12.67|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||12.67|-1.55|0.1142
91506811|NCT04206293|182884793|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.82||0.2592|TWO_SIDED|95.0|-0.78|2.71|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 28||2.71|-0.78|0.2592
91506812|NCT04206293|182884793|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.69||0.1341|TWO_SIDED|95.0|-0.38|2.57|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 84||2.57|-0.38|0.1341
91506813|NCT04206293|182884793|SUPERIORITY||LS Mean Difference|5.91|STANDARD_ERROR_OF_MEAN|4.55||0.2138|TWO_SIDED|95.0|-3.79|15.61|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 28||15.61|-3.79|0.2138
91506814|NCT04206293|182884793|SUPERIORITY||LS Mean Difference|8.22|STANDARD_ERROR_OF_MEAN|4.2||0.07|TWO_SIDED|95.0|-0.77|17.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 84||17.20|-0.77|0.0700
91506815|NCT04206293|182884794|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|2.17||0.9608|TWO_SIDED|95.0|-4.7|4.91|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.91|-4.70|0.9608
91506816|NCT04206293|182884794|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|2.79||0.6192|TWO_SIDED|95.0|-7.48|4.64|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||4.64|-7.48|0.6192
91532396|NCT00087490|182941399|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.|Percent Difference|4.2||||0.249|TWO_SIDED|95.0|-3.0|11.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).||11.5|-3.0|0.249
91751786|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.95|||||TWO_SIDED|95.0|0.89|1.02||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.89|
91751787|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.9|||||TWO_SIDED|95.0|0.84|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.84|
91751788|NCT02214225|183396412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|1.03|||||TWO_SIDED|95.0|0.94|1.14||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.14|0.94|
91506817|NCT04206293|182884795|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.8322|TWO_SIDED|95.0|-0.2|0.16|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.16|-0.20|0.8322
91506818|NCT04206293|182884795|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1334|TWO_SIDED|95.0|-0.25|0.04|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.04|-0.25|0.1334
91506819|NCT04206293|182884796|SUPERIORITY||LS Mean Difference|-5.09|STANDARD_ERROR_OF_MEAN|7.78||0.5221|TWO_SIDED|95.0|-21.56|11.38|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||11.38|-21.56|0.5221
91506820|NCT04206293|182884796|SUPERIORITY||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|8.07||0.4174|TWO_SIDED|95.0|-10.55|24.03|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||24.03|-10.55|0.4174
91506821|NCT04206293|182884797|SUPERIORITY||LS Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|2.58||0.3052|TWO_SIDED|95.0|-2.9|8.44|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||8.44|-2.90|0.3052
91506822|NCT04206293|182884797|SUPERIORITY||LS Mean Difference|9.99|STANDARD_ERROR_OF_MEAN|2.57||0.0016|TWO_SIDED|95.0|4.48|15.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||15.50|4.48|0.0016
91506823|NCT04206293|182884798|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.48||0.1672|TWO_SIDED|95.0|-0.33|1.73|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.73|-0.33|0.1672
91506824|NCT04206293|182884798|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.0881|TWO_SIDED|95.0|-0.1|1.21|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.21|-0.10|0.0881
91506825|NCT04206293|182884799|SUPERIORITY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.28||0.0577|TWO_SIDED|95.0|-0.02|1.17|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.17|-0.02|0.0577
91532397|NCT00087490|182941400|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|3.9||||0.168|TWO_SIDED|95.0|-1.7|9.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||9.5|-1.7|0.168
91506826|NCT04206293|182884799|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5224|TWO_SIDED|95.0|-0.85|0.45|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.45|-0.85|0.5224
91506827|NCT04206293|182884800|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2666|TWO_SIDED|95.0|-0.6|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.2|-0.6|0.2666
91506828|NCT04206293|182884800|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4366|TWO_SIDED|95.0|-0.3|0.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.7|-0.3|0.4366
91532398|NCT00087490|182941401|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.1||||0.048|TWO_SIDED|95.0|0.1|14.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||14.2|0.1|0.048
91532399|NCT00087490|182941402|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|4.8||||0.09|TWO_SIDED|95.0|-0.7|10.3|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||10.3|-0.7|0.090
91532400|NCT00087490|182941403|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|6.6||||0.127|TWO_SIDED|95.0|-1.9|15.0|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.0|-1.9|0.127
91532401|NCT00087490|182941404|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|16.6||||0|TWO_SIDED|95.0|9.0|24.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||24.2|9.0|0.000
91532402|NCT00087490|182941405|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.7||||0.051|TWO_SIDED|95.0|0.0|15.4|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.4|-0.0|0.051
91532403|NCT00087490|182941406|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|15.0||||0|TWO_SIDED|95.0|8.2|21.8|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||21.8|8.2|0.000
91532404|NCT00087490|182941409|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.022
91532405|NCT00087490|182941410|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.016
91532406|NCT00087490|182941411|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
91506829|NCT04206293|182884801|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4197|TWO_SIDED|95.0|-0.6|0.3|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 28||0.3|-0.6|0.4197
91506830|NCT04206293|182884801|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.914|TWO_SIDED|95.0|-0.6|0.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 84||0.5|-0.6|0.9140
91506831|NCT04206293|182884801|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7604|TWO_SIDED|95.0|-0.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 28||0.4|-0.6|0.7604
91506832|NCT04206293|182884801|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5936|TWO_SIDED|95.0|-1.0|0.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 84||0.6|-1.0|0.5936
91506833|NCT04206293|182884801|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0808|TWO_SIDED|95.0|-0.9|0.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 28||0.1|-0.9|0.0808
91532407|NCT00087490|182941412|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
91532408|NCT01925170|182941416|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of the two groups for all densities, significant difference p ≤ 0.05.||||<0.001
91532409|NCT01925170|182941416|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison of two groups for all densities; significant difference p ≤ 0.05.||||0.004
91506834|NCT04206293|182884801|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1633|TWO_SIDED|95.0|-1.0|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 84||0.2|-1.0|0.1633
91506835|NCT04206293|182884802|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1977|TWO_SIDED|95.0|-1.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.4|-1.6|0.1977
91532410|NCT01925170|182941417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
91532411|NCT01925170|182941417|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.0001
91532412|NCT01925170|182941418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
91532413|NCT01925170|182941418|SUPERIORITY_OR_OTHER|||||||0.004|||||||McNemar|||Significant difference p ≤ 0.05||||0.004
91532414|NCT01925170|182941419|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
91532415|NCT01925170|182941419|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
91532416|NCT01925170|182941420|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
91751789|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-2.1|||||TWO_SIDED|95.0|-6.9|2.6||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.6|-6.9|
91751790|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-4.6|||||TWO_SIDED|95.0|-9.3|0.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||0.2|-9.3|
91751791|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-4.5|||||TWO_SIDED|95.0|-10.3|1.3||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.3|-10.3|
91751792|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-4.6|||||TWO_SIDED|95.0|-10.5|1.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.2|-10.5|
91751793|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-0.2|||||TWO_SIDED|95.0|-4.4|4.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||4.0|-4.4|
91751794|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|1.1|||||TWO_SIDED|95.0|-3.1|5.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||5.2|-3.1|
91751795|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-2.2|||||TWO_SIDED|95.0|-6.3|2.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.0|-6.3|
91751796|NCT02214225|183396413|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|1.2|||||TWO_SIDED|95.0|-3.7|6.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||6.2|-3.7|
91751797|NCT02214225|183396414|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) overall|1.47|||||TWO_SIDED|95.0|1.38|1.57|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.57|1.38|
91751798|NCT02214225|183396414|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) overall|1.57|||||TWO_SIDED|95.0|1.45|1.7|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.70|1.45|
91751799|NCT02214225|183396414|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) 18 through 64 years|1.67|||||TWO_SIDED|95.0|1.5|1.87|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.87|1.50|
91532417|NCT01925170|182941420|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
91506836|NCT04206293|182884802|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7535|TWO_SIDED|95.0|-2.2|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-2.2|0.7535
91506837|NCT04206293|182884803|SUPERIORITY||LS Mean Difference|4.35|STANDARD_ERROR_OF_MEAN|3.95||0.2905|TWO_SIDED|95.0|-4.16|12.85|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||12.85|-4.16|0.2905
91506838|NCT04206293|182884803|SUPERIORITY||LS Mean Difference|17.27|STANDARD_ERROR_OF_MEAN|6.37||0.0241|TWO_SIDED|95.0|2.84|31.69|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||31.69|2.84|0.0241
91506839|NCT00782210|182884827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.135|<0.0001
91506840|NCT00782210|182884827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.214|0.139|<0.0001
91532418|NCT03862482|182941431|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.22|-0.49||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 35 Brånemark® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.49|-1.22|<0.05
91535618|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.89|STANDARD_ERROR_OF_MEAN|2.48||0.0001|TWO_SIDED|95.0|-14.8|-4.99||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.99|-14.80|0.0001
91751800|NCT02214225|183396414|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) 18 through 64 years|1.76|||||TWO_SIDED|95.0|1.55|2.01|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||2.01|1.55|
91506841|NCT00782210|182884828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.128|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.128|0.054|<0.0001
91506842|NCT00782210|182884828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|0.064|<0.0001
91506843|NCT00782210|182884829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.113|0.233|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.233|0.113|<0.0001
91506844|NCT00782210|182884829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.108|0.229|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.229|0.108|<0.0001
91506845|NCT00782210|182884830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
91506846|NCT00782210|182884830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.139|<0.0001
91506847|NCT00782210|182884831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.144|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.144|<0.0001
91506848|NCT00782210|182884831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.156|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.156|<0.0001
91506849|NCT00782210|182884832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.133|<0.0001
91506850|NCT00782210|182884832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.13|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.130|<0.0001
91751801|NCT02214225|183396414|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) ≥ 65 years|1.3|||||TWO_SIDED|95.0|1.21|1.4|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.40|1.21|
91506851|NCT00782210|182884833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.136|<0.0001
91532419|NCT03862482|182941431|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.35|-0.64||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Swede-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.64|-1.35|<0.05
91506852|NCT00782210|182884833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.199|0.123|<0.0001
91532420|NCT03862482|182941431|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Median Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-2.13|-1.41||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Screw-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-1.41|-2.13|<0.05
91532421|NCT02300311|182941444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.849|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|-2.454|-1.244||The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo).|"PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours."||-1.244|-2.454|<0.0001
91532422|NCT02300311|182941445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.341|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|-1.832|-0.851||The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo)|"PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours."||-0.851|-1.832|<0.0001
91506853|NCT00782210|182884834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.134|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.134|<0.0001
91506854|NCT00782210|182884834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.208|0.131|<0.0001
91532423|NCT02300311|182941446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.958|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.712|-2.205|||ANCOVA|ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.|Differences between the treatment group effects (Finalgon® cream - placebo)|The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.||-2.205|-3.712|<0.0001
91532424|NCT02300311|182941447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.0001|TWO_SIDED|95.0|5.342|24.199|||Regression, Logistic|Ordinal logistic regression models adjusting for the continuous covariate 'baseline PI' and the categorical variable 'country' was performed.|Odds ratio of (Finalgon® cream / placebo)|"For the analysis of the repeated multinomial efficacy endpoint 'patient assessment of efficacy' on the last individual treatment day, ordinal logistic regression models is used.~Only non-missing data is analysed in the statistical model."||24.199|5.342|<0.0001
91532425|NCT00848211|182941448|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
91532426|NCT00848211|182941450|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
91506855|NCT00782210|182884835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
91532427|NCT00994279|182941479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Chi-squared|||Null hypothesis is that the two arms will not differ in retention at 14 weeks.||||.53
91506856|NCT00782210|182884835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.075|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.147|0.075|<0.0001
91532428|NCT00994279|182941480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.||||.98
91532429|NCT01606189|182941481|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.58||||0.005|TWO_SIDED|95.0|-0.98|-0.18|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.18|-0.98|0.005
91532430|NCT01606189|182941481|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.002|TWO_SIDED|95.0|-1.03|-0.24|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.24|-1.03|0.002
91532431|NCT01606189|182941482|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.2||||0.017|TWO_SIDED|95.0|-0.37|-0.04|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.04|-0.37|0.017
91506857|NCT00782210|182884836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
91506858|NCT00782210|182884836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.127|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.127|0.054|<0.0001
91506859|NCT00782210|182884837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.061|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.135|0.061|<0.0001
91506860|NCT00782210|182884837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|0.064|<0.0001
91506861|NCT00782210|182884838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.049|<0.0001
91506862|NCT00782210|182884838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.051|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.126|0.051|<0.0001
91532432|NCT01606189|182941482|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.16|-0.49|<0.001
91532433|NCT01606189|182941483|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.55||||0.019|TWO_SIDED|95.0|0.09|1.01|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.01|0.09|0.019
91506863|NCT00782210|182884839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.054|<0.0001
91506864|NCT00782210|182884839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.048|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.123|0.048|<0.0001
91506865|NCT00782210|182884840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.069|0.145|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.145|0.069|<0.0001
91506866|NCT00782210|182884840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.068|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|0.068|<0.0001
91506867|NCT00782210|182884841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.055|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.055|<0.0001
91506868|NCT00782210|182884841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.053|0.129|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.129|0.053|<0.0001
91506869|NCT00782210|182884842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.115|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.194|0.115|<0.0001
91506870|NCT00782210|182884842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.131|<0.0001
91506871|NCT00782210|182884843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.137|<0.0001
91506872|NCT00782210|182884843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.23|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.230|0.150|<0.0001
91506873|NCT00782210|182884844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.132|<0.0001
91506874|NCT00782210|182884844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.132|<0.0001
91506875|NCT00782210|182884845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.123|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.204|0.123|<0.0001
91506876|NCT00782210|182884845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
91506877|NCT00782210|182884846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.134|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.216|0.134|<0.0001
91506878|NCT00782210|182884846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.192|0.110|<0.0001
91506879|NCT00782210|182884847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.128|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.128|<0.0001
91532434|NCT01606189|182941483|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.79||||0.001|TWO_SIDED|95.0|0.33|1.24|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.24|0.33|0.001
91506880|NCT00782210|182884847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.121|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.205|0.121|<0.0001
91506881|NCT00782210|182884848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.216|0.359|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.359|0.216|<0.0001
91506882|NCT00782210|182884848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.258|0.401|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.401|0.258|<0.0001
91506883|NCT00782210|182884849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.224|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.368|0.224|<0.0001
91506884|NCT00782210|182884849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.255|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.399|0.255|<0.0001
91506885|NCT00782210|182884850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.181|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.181|<0.0001
91506886|NCT00782210|182884850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.22|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.220|<0.0001
91506887|NCT00782210|182884851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.201|0.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.348|0.201|<0.0001
91506888|NCT00782210|182884851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.219|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.219|<0.0001
91506889|NCT00782210|182884852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.309|0.161|<0.0001
91506890|NCT00782210|182884852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.180|<0.0001
91506891|NCT00782210|182884853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.169|0.319|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.319|0.169|<0.0001
91506892|NCT00782210|182884853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.271|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.196|0.346|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.346|0.196|<0.0001
91506893|NCT00782210|182884854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.076|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.218|0.076|<0.0001
91506894|NCT00782210|182884854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.113|0.255|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.255|0.113|<0.0001
91506895|NCT00782210|182884855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.059|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.059|0.0003
91532435|NCT01606189|182941484|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.55||||0.146|TWO_SIDED|95.0|-3.64|0.55|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||0.55|-3.64|0.146
91532436|NCT01606189|182941484|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.2||||0.04|TWO_SIDED|95.0|-4.29|-0.1|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||-0.10|-4.29|0.040
91532437|NCT01606189|182941485|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.28||||0.092|TWO_SIDED|95.0|-15.78|1.21|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||1.21|-15.78|0.092
91532438|NCT01606189|182941485|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.99||||0.037|TWO_SIDED|95.0|-17.41|-0.57|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||-0.57|-17.41|0.037
91506896|NCT00782210|182884855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.036||0.0001||95.0|0.069|0.213|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.213|0.069|0.0001
91506897|NCT00782210|182884856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.037||0.0019||95.0|0.043|0.187|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.187|0.043|0.0019
91506898|NCT00782210|182884856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.088|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.088|<0.0001
91506899|NCT00782210|182884857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.037||0.0005||95.0|0.057|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.057|0.0005
91506900|NCT00782210|182884857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.089|0.235|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.235|0.089|<0.0001
91506901|NCT00782210|182884858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.037||0.0261||95.0|0.01|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.010|0.0261
91506902|NCT00782210|182884858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.05|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.050|0.0010
91506903|NCT00782210|182884859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.038||0.0154||95.0|0.018|0.165|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.165|0.018|0.0154
91532439|NCT01606189|182941486|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1222.0||||0.328||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.328
91751802|NCT02214225|183396414|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) ≥ 65 years|1.38|||||TWO_SIDED|95.0|1.27|1.51|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.51|1.27|
91506904|NCT00782210|182884859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.038||0.0011||95.0|0.049|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.049|0.0011
91506905|NCT00782210|182884860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.038||0.0006||95.0|0.057|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.205|0.057|0.0006
91751803|NCT02214225|183396415|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) overall|15.3|||||TWO_SIDED|95.0|12.1|18.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||18.6|12.1|
91751804|NCT02214225|183396415|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) overall|20.1|||||TWO_SIDED|95.0|16.5|23.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||23.6|16.5|
91751805|NCT02214225|183396415|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) 18 through 64y|22.9|||||TWO_SIDED|95.0|17.7|28.2|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||28.2|17.7|
91532440|NCT01606189|182941486|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1200.5||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.560
91506906|NCT00782210|182884860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.08|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.080|<0.0001
91506907|NCT00782210|182884861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.038||0.0134||95.0|0.019|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.168|0.019|0.0134
91506908|NCT00782210|182884861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025||95.0|0.04|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.040|0.0025
91506909|NCT00782210|182884862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.187|0.339|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.339|0.187|<0.0001
91751806|NCT02214225|183396415|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) 18 through 64y|28.6|||||TWO_SIDED|95.0|23.1|34.1|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||34.1|23.1|
91506910|NCT00782210|182884862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.225|0.376|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.376|0.225|<0.0001
91506911|NCT00782210|182884863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.188|0.341|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.341|0.188|<0.0001
91532441|NCT01606189|182941487|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.75||||0.181|TWO_SIDED|95.0|-4.32|0.83|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||0.83|-4.32|0.181
91751807|NCT02214225|183396415|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) ≥ 65 years|8.0|||||TWO_SIDED|95.0|4.3|11.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||11.6|4.3|
91532442|NCT01606189|182941487|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.43||||0.739|TWO_SIDED|95.0|-2.12|2.98|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||2.98|-2.12|0.739
91532443|NCT01606189|182941488|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.23||||0.015|TWO_SIDED|95.0|-4.01|-0.45|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||-0.45|-4.01|0.015
91506912|NCT00782210|182884863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.216|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.368|0.216|<0.0001
91506913|NCT00782210|182884864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.174|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.328|0.174|<0.0001
91506914|NCT00782210|182884864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.203|0.358|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.358|0.203|<0.0001
91506915|NCT00782210|182884865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.174|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.329|0.174|<0.0001
91532444|NCT01606189|182941488|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.21||||0.178|TWO_SIDED|95.0|-2.97|0.56|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||0.56|-2.97|0.178
91751808|NCT02214225|183396415|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) ≥ 65 years|11.9|||||TWO_SIDED|95.0|7.7|16.0|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.||16.0|7.7|
91751809|NCT01669421|183396433|OTHER|Data was analyzed with multiple repeat ANOVA for all visits and paired samples were also evaluated.|||||<|0.05|||||||Kruskal-Wallis|||IL-2||||<0.05
91751810|NCT01669421|183396433|OTHER|Kruskal-Wallis||||||0.035|||||||Kruskal-Wallis|||IL-4||||0.035
91751811|NCT01669421|183396433|OTHER|||||||0.33|||||||Kruskal-Wallis|||IL-8||||0.33
91751812|NCT01669421|183396433|OTHER|||||||0.68|||||||Kruskal-Wallis|||IL-9||||0.68
91751813|NCT01669421|183396433|OTHER|||||||0.02|||||||Kruskal-Wallis|||IL-17||||0.020
91751814|NCT01669421|183396433|OTHER|||||||0.021|||||||Kruskal-Wallis|||FGF||||0.021
91751815|NCT01669421|183396433|OTHER|||||||0.02|||||||Kruskal-Wallis|||Eotaxin||||0.02
91751816|NCT01669421|183396433|OTHER|||||||0.045|||||||Kruskal-Wallis|||GM-CSF||||0.045
91751817|NCT01669421|183396433|OTHER|||||||0.47|||||||Kruskal-Wallis|||IL15||||0.47
91751818|NCT01669421|183396433|OTHER|||||||0.9|||||||Kruskal-Wallis|||IL-1a||||0.90
91751819|NCT01669421|183396433|OTHER|||||||0.8|||||||Kruskal-Wallis|||IL18||||0.80
91751820|NCT01669421|183396433|OTHER|||||||0.027|||||||Kruskal-Wallis|||M-CSF||||0.027
91751821|NCT01669421|183396434|OTHER|||||||0.07|||||||Kruskal-Wallis|||No power calculation and this is an exploratory pilot analysis We expected cytokines to decrease after subjects receive double dose and a rebound after administering standard dose.||||0.07
91751822|NCT01669421|183396436|OTHER|between Week 4 and Week 8||||||0.03|||||||t-test, 2 sided|||Desmosine (DES) and isodesmosine (IDES) are used as indicator of elastin degradation. Levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry.||||0.03
91751823|NCT01669421|183396436|OTHER|||||||0.33|||||||t-test, 2 sided|||between Week 8 and Week 12||||0.33
91751824|NCT01669421|183396436|OTHER|||||||0.029|||||||Kruskal-Wallis|||between Week 4 and Week 12||||0.029
91751825|NCT02961790|183396455|SUPERIORITY|||||||0.0041|||||||Kruskal-Wallis|||||||0.0041
91751826|NCT02961790|183396455|SUPERIORITY|||||||0.0001|||||||Kruskal-Wallis|||||||0.0001
91751827|NCT02961790|183396456|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
91751828|NCT02961790|183396457|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
91751829|NCT02961790|183396458|SUPERIORITY|||||||0.0174|||||||Kruskal-Wallis|||||||0.0174
91751830|NCT02961790|183396458|SUPERIORITY|||||||0.0279|||||||Kruskal-Wallis|||||||0.0279
91751831|NCT02961790|183396459|SUPERIORITY|||||||0.0011|||||||Kruskal-Wallis|||||||0.0011
91751832|NCT02961790|183396459|SUPERIORITY|||||||0.0025|||||||Kruskal-Wallis|||||||0.0025
91751833|NCT00300482|183396484|SUPERIORITY_OR_OTHER||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
91751834|NCT00300482|183396484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
91751835|NCT00300482|183396485|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91751836|NCT00300482|183396485|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91751837|NCT00300482|183396486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91751838|NCT00300482|183396486|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91751839|NCT01400243|183396499|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANCOVA|||||||.05
91751840|NCT01400243|183396500|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91751841|NCT00953680|183396504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.993||||||90.0|0.95|1.039||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.039|0.950|
91751842|NCT00953680|183396505|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.835||||||90.0|0.749|0.931||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100-mg tablet + HCTZ 12.5 mg capsule||0.931|0.749|
91751843|NCT00953680|183396506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.924||||||90.0|0.825|1.035||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.035|0.825|
91751844|NCT00953680|183396507|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.931||||||90.0|0.836|1.037||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.037|0.836|
91751845|NCT02370004|183396515|OTHER|||||||0.1|||||||t-test, 2 sided|||Paired T-tests were used to evaluate changes in spirometry results||||.10
91751846|NCT01891344|183396530|SUPERIORITY||Cox Proportional Hazard|0.273|||||TWO_SIDED|95.0|0.17|0.437||||||||0.437|0.170|
91751847|NCT01891344|183396530|SUPERIORITY||Cox Proportional Hazard|0.61|||||TWO_SIDED|95.0|0.428|0.871||||||||0.871|0.428|
91751848|NCT01852825|183396538|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.355||||0.003|TWO_SIDED|90.0|1.515|3.661|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.661|1.515|0.003
91751849|NCT01852825|183396539|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.182||||0.01|TWO_SIDED|90.0|1.364|3.49|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.490|1.364|0.010
91751850|NCT01852825|183396540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.027|TWO_SIDED|90.0|0.066|0.41|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|The hypothesis is supported if the lower bound of the 1-tailed 95% CI around the mean difference in change from baseline excludes zero||0.410|0.066|0.027
91751851|NCT01852825|183396541|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.068||||0.935|TWO_SIDED|90.0|0.272|4.19|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||4.190|0.272|0.935
91751852|NCT01852825|183396542|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.21||||0.296|TWO_SIDED|90.0|0.605|8.066|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||8.066|0.605|0.296
91751853|NCT01852825|183396543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.115||||0.014|TWO_SIDED|90.0|-100.185|-22.045|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|||-22.045|-100.185|0.014
91751854|NCT01394614|183396563|SUPERIORITY_OR_OTHER||Incidence-rate difference|0.41|||||TWO_SIDED||||||||Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years|||||
91751855|NCT01394614|183396563|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.32|||||TWO_SIDED|95.0|1.5|11.12|||||Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).|||11.12|1.5|
91751856|NCT01149486|183396564|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.45|||||TWO_SIDED|90.0|80.2|108.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.88|80.20|
91751857|NCT01149486|183396565|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.45|||||TWO_SIDED|90.0|93.15|106.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.18|93.15|
91751858|NCT01149486|183396566|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|93.1|106.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.12|93.10|
91751859|NCT01149486|183396567|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|111.62|||||TWO_SIDED|90.0|101.47|122.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||122.79|101.47|
91532445|NCT00519636|182941498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001||95.0|-1.3|-0.3|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo.|FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP).||-0.3|-1.3|<0.001
91532446|NCT00519636|182941498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.014||95.0|-1.1|-0.1|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo.|FPNS combined across treatment arms 1 (FPNS/FFNS) \& 2 (Placebo FP/FF) compared with Placebo FPNS combined across treatment arms 1 (FPNS/FFNS)\& 2 (Placebo FP/FF).||-0.1|-1.1|0.014
91532447|NCT00519636|182941499|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximate to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||||||<0.001
91532448|NCT03077620|182941592|SUPERIORITY||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.064||0.05|TWO_SIDED|95.0|-0.017|0.256||Poor sleepers compared to good sleepers with Compound Symmetry covariance structure. Mean difference is poor sleepers minus good sleepers.|Mixed Models Analysis|||||0.256|-0.017|0.05
91532449|NCT03077620|182941593|SUPERIORITY||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.078|0.087||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.087|-0.078|0.05
91532450|NCT03077620|182941593|SUPERIORITY||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.051|0.117||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.117|-0.051|0.05
91532451|NCT00550173|182941603|SUPERIORITY_OR_OTHER|||||||0.003||||||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Overall; Global null hypothesis was rejected at 2-sided 0.2 significance level.||||0.003
91751860|NCT01149486|183396568|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|99.58|112.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.41|99.58|
91751861|NCT01149486|183396569|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.55|||||TWO_SIDED|90.0|99.64|111.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.82|99.64|
91751862|NCT01149486|183396570|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.78|||||TWO_SIDED|90.0|98.96|115.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||115.23|98.96|
91751863|NCT01149486|183396571|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.37|||||TWO_SIDED|90.0|98.75|106.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.14|98.75|
91751864|NCT01149486|183396572|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.3|||||TWO_SIDED|90.0|98.72|106.01|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.01|98.72|
91751865|NCT00598078|183396612|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||||||0.013
91751866|NCT00598078|183396612|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||ANOVA|||||||0.713
91506916|NCT00782210|182884865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.183|0.338|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.338|0.183|<0.0001
91751867|NCT00598078|183396612|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANOVA|||||||0.038
91751868|NCT00434759|183396659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value is not adjusted for multiple comparisons|ANOVA|We report the interaction effect.|The reported interaction effect is significant (p\< .05) in favour of standard therapy.|||||<0.05
91751869|NCT00434759|183396660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
91751870|NCT00434759|183396661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.05||95.0||||p-value is not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
91751871|NCT00434759|183396662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction is not significant.|||||<0.05
91506917|NCT00782210|182884866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.153|<0.0001
91506918|NCT00782210|182884866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.154|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.311|0.154|<0.0001
91751872|NCT00434759|183396663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.05||95.0||||priori threshold for statistical significance ist 0.05 p-value ist nor adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is significant (p \< .05) in favour of standard therapy|||||<0.05
91751873|NCT01318070|183396677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|95.0|-0.224|-0.135||||||||-0.135|-0.224|
91751874|NCT01318070|183396677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.225|-0.135||||||||-0.135|-0.225|
91751875|NCT01318070|183396678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|||||TWO_SIDED|95.0|-0.434|-0.292||||||||-0.292|-0.434|
91751876|NCT01318070|183396678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-0.432|-0.287||||||||-0.287|-0.432|
91751877|NCT01318070|183396679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|||||TWO_SIDED|95.0|-0.692|-0.484||||||||-0.484|-0.692|
91751878|NCT01318070|183396679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||||TWO_SIDED|95.0|-0.743|-0.526||||||||-0.526|-0.743|
91751879|NCT01318070|183396680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||||TWO_SIDED|95.0|-13.2|-4.47||||||||-4.47|-13.20|
91751880|NCT01318070|183396680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-17.86|-8.26||||||||-8.26|-17.86|
91751881|NCT01318070|183396681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.24|||||TWO_SIDED|95.0|-16.22|-6.25||||||||-6.25|-16.22|
91751882|NCT01318070|183396681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|||||TWO_SIDED|95.0|-20.0|-9.63||||||||-9.63|-20.00|
91751883|NCT01318070|183396682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.88|||||TWO_SIDED|95.0|-18.09|-7.68||||||||-7.68|-18.09|
91751884|NCT01318070|183396682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||||TWO_SIDED|95.0|-22.64|-11.53||||||||-11.53|-22.64|
91751885|NCT01318070|183396683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.46|||||TWO_SIDED|95.0|-18.51|-6.4||||||||-6.40|-18.51|
91751886|NCT01318070|183396683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.49|||||TWO_SIDED|95.0|-22.78|-10.19||||||||-10.19|-22.78|
91751887|NCT01318070|183396684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||||TWO_SIDED|95.0|-21.51|-3.1||||||||-3.10|-21.51|
91751888|NCT01318070|183396684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-30.43|-11.95||||||||-11.95|-30.43|
91751889|NCT01318070|183396685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.717|||||TWO_SIDED|95.0|-0.848|-0.586||||||||-0.586|-0.848|
91751890|NCT01318070|183396685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.773|||||TWO_SIDED|95.0|-0.913|-0.634||||||||-0.634|-0.913|
91506919|NCT00782210|182884867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.168|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.168|<0.0001
91506920|NCT00782210|182884867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.181|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.340|0.181|<0.0001
91506921|NCT00782210|182884868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.181|0.422|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.422|0.181|<0.0001
91751891|NCT02312765|183396686|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
91751892|NCT00042432|183396693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.67||||0.006||95.0|1.6|20.06|||Cochran-Mantel-Haenszel|Adjusted for baseline glomenular filtration rate (GFR) strata|Logit estimates|||20.06|1.60|0.006
91506922|NCT00782210|182884868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.128|0.37|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.370|0.128|<0.0001
91506923|NCT00782210|182884869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.357|STANDARD_ERROR_OF_MEAN|4.253||0.0018|TWO_SIDED|95.0|5.005|21.709|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||21.709|5.005|0.0018
91506924|NCT00782210|182884869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.457|STANDARD_ERROR_OF_MEAN|4.248||0.0003|TWO_SIDED|95.0|7.114|23.8|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||23.800|7.114|0.0003
91506925|NCT00782210|182884870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.186|STANDARD_ERROR_OF_MEAN|4.245|<|0.0001|TWO_SIDED|95.0|8.849|25.523|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||25.523|8.849|<0.0001
91751893|NCT00042432|183396694|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adusted for baseline glomerular filtration rate (GFR) strata||||||<0.001
91506926|NCT00782210|182884870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.56|STANDARD_ERROR_OF_MEAN|4.226||0.0006|TWO_SIDED|95.0|6.259|22.86|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||22.860|6.259|0.0006
91751894|NCT00432744|183396759|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.015|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED|95.0|-0.44|0.48||Two-sided Test|Wilcoxon (Mann-Whitney)||Positive value of Tau-B would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.48|-0.44|0.95
91751895|NCT00432744|183396760|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.18|TWO_SIDED|95.0|-0.12|0.72|||Wilcoxon (Mann-Whitney)||A positive value would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.72|-0.12|0.18
91751896|NCT00432744|183396761|SUPERIORITY_OR_OTHER|||||||0.42||||||The Hotelling T-sq=1.74 and 42% of the rerandomizations to groups of 7 and 8 had Hotelling T-sq of at least 1.74. This is the standard method for permutation tests. The large sample null is chi-sq with 2 df, which has a mean=2.|Non-parametric Hotelling T-square|||The actual study was powered to have 40 participants but only 24 participated and of these only 15 had outcome data.||||0.42
91751897|NCT01735708|183396762|SUPERIORITY|ITT analysis using multiple imputation by chained equation with 50 fully populated data sets.|Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|0.493||0.008|TWO_SIDED|95.0|-2.28|-0.34||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|standard error of difference in means|||-0.34|-2.28|0.008
91751898|NCT01735708|183396763|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.495||0.251|TWO_SIDED|95.0|-1.53|0.4||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.||||0.40|-1.53|0.251
91506927|NCT00782210|182884871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.182||0.0045|TWO_SIDED|95.0|-0.878|-0.162|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.162|-0.878|0.0045
91751899|NCT01735708|183396764|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.75||0.844|TWO_SIDED|95.0|-1.32|1.61||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.61|-1.32|0.844
91751900|NCT01735708|183396765|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.836||0.545|TWO_SIDED|95.0|-2.18|1.15||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.15|-2.18|0.545
91751901|NCT00461305|183396766|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|13.4|||||TWO_SIDED|95.0|9.73|17.77|||Binominal parameter by exact method||No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.|Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.||17.77|9.73|
91751902|NCT00461305|183396766|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|7.1||||||95.0|1.98|17.29|||Binominal parameter by exact method|||Exact 95% confident intervals were calculated using F-distribution by treatment group.||17.29|1.98|
91751903|NCT01294462|183396819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.53||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.53|0.94|
91751904|NCT01294462|183396820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.88|2.44||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.44|0.88|
91751905|NCT01294462|183396821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72|||||TWO_SIDED|95.0|1.23|2.4||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.40|1.23|
91751906|NCT01294462|183396822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|95.0|0.91|2.5||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.50|0.91|
91751907|NCT00085254|183396825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4|TWO_SIDED|95.0|0.5|1.3|||Regression, Cox|||||1.3|0.5|0.4
91751908|NCT00085254|183396827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0001|TWO_SIDED|95.0|0.3|0.5||adjusted for age: p=.0003, kps: p=.004; and surgical procedure: p=.003|Log Rank|||Primary endpoint death - defined from histological diagnosis to death. we assume pt in the study will have overall failure rate of 0.56 per person-year of f/up, a 30% reduction compared to hazard rate of 0.8 per person-year in historical NABTT database. Expected hazard ratio is 0.7 and cohort will produce 63 events among total of 94 pt planned f/up. One-sided test, have 95% power to detect observed ratio of 0.7 at alpha level of 0.1, or we have 88% power at alpha of 0.5 statistical significant||0.5|0.3|0.0001
91506928|NCT00782210|182884871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|95.0|-1.005|-0.291|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.291|-1.005|0.0004
91751909|NCT04342689|183396828|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
91751910|NCT04342689|183396829|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
91751911|NCT04342689|183396830|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91751912|NCT01460407|183396831|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.28|||||TWO_SIDED|90.0|1.16|1.42|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.42|1.16|
91751913|NCT01460407|183396832|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.21|||||TWO_SIDED|90.0|1.12|1.31|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.31|1.12|
91751914|NCT01460407|183396833|SUPERIORITY_OR_OTHER||Median of paired differences|0.0||||0.7656|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||LY2216684 and Clarithromycin minus (-) LY2216684|||0.50|-0.50|0.7656
91751915|NCT02818114|183396835|OTHER|Assessment of number of PE sessions attended, review of direction of change in PTSD Checklist scores||||||||||||||||This is a single-arm feasibility study. With N=8, formal hypothesis testing is not possible. We were assessing the extent to which veterans would be willing to engage in the intervention, and if the direction of change in symptoms is still in the expected direction when peer support services are added. Outcomes are reported more qualitatively.|As a feasibility trial, tests of statistical significance are not appropriate.|||
91751916|NCT00844805|183396843|SUPERIORITY_OR_OTHER||Difference in Percentages|14.9|||=|0.0884|TWO_SIDED|95.0|-1.7|31.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.5|-1.7|=0.0884
91751917|NCT00844805|183396844|SUPERIORITY_OR_OTHER||Difference in Percentages|21.7|||=|0.0013|TWO_SIDED|95.0|11.0|32.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||32.5|11.0|=0.0013
91506929|NCT00782210|182884872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.582|STANDARD_ERROR_OF_MEAN|0.202||0.0041|TWO_SIDED|95.0|-0.979|-0.185|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.185|-0.979|0.0041
91751918|NCT00844805|183396845|SUPERIORITY_OR_OTHER||Difference in Percentages|18.1|||=|0.0004|TWO_SIDED|95.0|10.7|25.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||25.5|10.7|=0.0004
91751919|NCT00844805|183396846|SUPERIORITY_OR_OTHER||Difference in Percentages|10.0|||=|0.5005|TWO_SIDED|95.0|-11.7|31.7|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.7|-11.7|=0.5005
91751920|NCT00844805|183396847|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.5|||=|1|TWO_SIDED|95.0|-14.9|9.9|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||9.9|-14.9|=1.0000
91751921|NCT00844805|183396848|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||=|1|TWO_SIDED|95.0|-6.8|6.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||6.8|-6.8|=1.0000
91751922|NCT00844805|183396849|SUPERIORITY_OR_OTHER||||||=|0.3802||95.0|||||Log Rank|||||||=0.3802
91751923|NCT00844805|183396850|SUPERIORITY_OR_OTHER||Difference in Percentages|-5.0|||=|0.6153|TWO_SIDED|95.0|-14.5|4.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||4.5|-14.5|=0.6153
91751924|NCT00844805|183396851|SUPERIORITY_OR_OTHER||Difference in Percentages|18.4|||=|0.0263|TWO_SIDED|95.0|2.5|34.3|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||34.3|2.5|=0.0263
91751925|NCT00844805|183396852|SUPERIORITY_OR_OTHER||Difference in Percentages|8.4|||=|0.3011|TWO_SIDED|95.0|-6.0|22.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||22.8|-6.0|=0.3011
91751926|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
91751927|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
91751928|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0313
91751929|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
91751930|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
91751931|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0156
91751932|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0078
91751933|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.1563||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.1563
91751934|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.4375||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.4375
91751935|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0781
91751936|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.||||0.0371
91751937|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0137
91751938|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0547
91751939|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.0488
91751940|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.3594
91751941|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.0488
91751942|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.1055||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.1055
91751943|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.9102||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.9102
91751944|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.1934
91751945|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.1641
91751946|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0137
91506930|NCT00782210|182884872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|0.202||0.0001|TWO_SIDED|95.0|-1.189|-0.394|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.394|-1.189|0.0001
91506931|NCT00782210|182884873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.104|STANDARD_ERROR_OF_MEAN|0.354||0.0019|TWO_SIDED|95.0|-1.799|-0.409|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.409|-1.799|0.0019
91532452|NCT00550173|182941603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.002|TWO_SIDED|95.0|0.4|0.81||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.81|0.40|0.002
91751947|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
91751948|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
91751949|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
91751950|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.0547
91751951|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0195
91751952|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0059
91751953|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.5703
91751954|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
91751955|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0039
91506932|NCT00782210|182884873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.435|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|95.0|-2.13|-0.74|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.740|-2.130|<0.0001
91506933|NCT00782210|182884874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
91506934|NCT00782210|182884874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
91506935|NCT00782210|182884875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
91751956|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole body, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.||||0.0039
91751957|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for whole body, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.||||0.5703
91751958|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for whole body, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.||||0.0273
91751959|NCT00259298|183396855|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value if for whole body, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.||||0.0039
91751960|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for whole skeleton, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.||||0.0098
91751961|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole skeleton, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.||||0.0039
91751962|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for whole skeleton, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.||||0.6523
91506936|NCT00782210|182884875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
91506937|NCT00782210|182884876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
91506938|NCT00782210|182884876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
91751963|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for whole skeleton, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.||||0.1641
91751964|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for whole skeleton, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.||||0.0078
91751965|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
91751966|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
91751967|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0781
91751968|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
91751969|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
91751970|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0391||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0391
91751971|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0313
91751972|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.2969||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.2969
91751973|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.5625||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.5625
91751974|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0469||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0469
91751975|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.1934
91751976|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.||||0.2324
91751977|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0645
91751978|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0273
91751979|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.7344
91751980|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.1934
91751981|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.7695||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.7695
91751982|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.6523
91751983|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.2324
91751984|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.6523
91506939|NCT00782210|182884877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0109||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0109
91751985|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0098
91751986|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
91506940|NCT00782210|182884877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0031||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0031
91532453|NCT00550173|182941603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.39|0.85||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.85|0.39|0.005
91751987|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
91751988|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
91751989|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.3594
91751990|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0371
91751991|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0098
91506941|NCT00782210|182884878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.728|STANDARD_ERROR_OF_MEAN|0.124||0.0658|TWO_SIDED|95.0|0.522|1.016|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.016|0.522|0.0658
91506942|NCT00782210|182884878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799|STANDARD_ERROR_OF_MEAN|0.133||0.1701|TWO_SIDED|95.0|0.576|1.107|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.107|0.576|0.1701
91751992|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.4609||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.4609
91751993|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
91751994|NCT00259298|183396856|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0273
91751995|NCT00259298|183396857|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.||||1.0
91751996|NCT00259298|183396857|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.||||1.0
91751997|NCT00259298|183396859|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for change at 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.||||0.0020
91751998|NCT02726880|183396877|SUPERIORITY||F|1.13||||0.296|TWO_SIDED||||||ANCOVA|Number of days of gaming in the past week, measured at baseline, is included as a covariate in the model.||||||.296
91751999|NCT01710527|183396922|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed Cmax fell within the acceptance range of 80 to 125%.|Ratio (%)|96.85||||0.3125|TWO_SIDED|90.0|91.86|102.11|||ANOVA||Analysis was performed on log transformed geometric least square means.|||102.11|91.86|0.3125
91752000|NCT01710527|183396923|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-t fell within the acceptance range of 80 to 125%.|Ratio (%)|102.52||||0.2701|TWO_SIDED|90.0|98.74|106.45|||ANOVA|||Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-t||106.45|98.74|0.2701
91752001|NCT01710527|183396923|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-infinity fell within the acceptance range of 80 to 125%.|Ratio (%)|102.44||||0.2702|TWO_SIDED|90.0|98.78|106.23|||ANOVA||Analysis was performed on log transformed geometric least square means.|Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-infinity.||106.23|98.78|0.2702
91752002|NCT01822535|183396932|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.||||<0.01
91752003|NCT01822535|183396933|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.018
91752004|NCT01822535|183396934|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.0431
91752005|NCT01822535|183396935|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||"We hypothesized that administration of midodrine would attenuate the fall in core body temperature.~Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug)."||||0.30
91752006|NCT01071356|183396936|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|-0.006||||0.47|TWO_SIDED|95.0|-0.023|0.011|||Random Effects modeling||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.011|-.023|.47
91752007|NCT01071356|183396937|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|0.007||||0.034|TWO_SIDED|95.0|0.001|0.013|||Random effects model||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.013|.001|.034
91752008|NCT02278614|183396938|OTHER|The change from baseline in mean IOP on Day 84 for the contralateral eye,|Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.43|||Mixed Models Analysis|||||0.43|-0.57|
91752009|NCT02278614|183396938|OTHER|The change from baseline in mean IOP on D42 for the worse eye|Adjusted mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-0.69|0.31|||Mixed Models Analysis|||||0.31|-0.69|
91506943|NCT00782210|182884879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.656|STANDARD_ERROR_OF_MEAN|0.247||0.2754|TWO_SIDED|95.0|0.313|1.374|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.374|0.313|0.2754
91752010|NCT00737711|183396946|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used to estimation of p-value.|t-test, 2 sided|||||||<0.0001
91752011|NCT02739321|183396974|NON_INFERIORITY|Hypothesized benchmark of 30%|Risk Difference (RD)|25.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91506944|NCT00782210|182884879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.342||0.9792|TWO_SIDED|95.0|0.521|1.961|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.961|0.521|0.9792
91506945|NCT00782210|182884880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739|STANDARD_ERROR_OF_MEAN|0.142||0.1194|TWO_SIDED|95.0|0.506|1.078|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.078|0.506|0.1194
91506946|NCT00782210|182884880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811|STANDARD_ERROR_OF_MEAN|0.153||0.257|TWO_SIDED|95.0|0.561|1.174|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.174|0.561|0.2570
91506947|NCT00782210|182884881|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7815|STANDARD_ERROR_OF_MEAN|0.138||0.1631|TWO_SIDED|95.0|0.5524|1.1054|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.1054|0.5524|0.1631
91752012|NCT02739321|183396975|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||.001
91752013|NCT02739321|183396976|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
91752014|NCT02739321|183396977|SUPERIORITY||Median Difference (Final Values)|4.09||||0.268|TWO_SIDED||||||Mixed Models Analysis|||||||.268
91752015|NCT02739321|183396978|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.058|TWO_SIDED||||||Mixed Models Analysis|||||||.058
91752016|NCT02739321|183396979|SUPERIORITY||Mean Difference (Final Values)|2.82||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
91752017|NCT02739321|183396980|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||||||.232
91752018|NCT02739321|183396981|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.100
91752019|NCT02739321|183396982|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
91752020|NCT02739321|183396983|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
91752021|NCT02739321|183396984|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.040
91752022|NCT02739321|183396985|SUPERIORITY|||||||0.471|||||||Mixed Models Analysis|||||||0.471
91752023|NCT02739321|183396986|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
91752024|NCT02739321|183396987|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91752025|NCT02739321|183396988|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of mattress technology was 5.61 (SE = 0.25).|||
91752026|NCT02739321|183396989|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of actigraph watch was 5.51 (SE = 0.13).|||
91752027|NCT02739321|183396990|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely difficult, 7 = extremely easy) that was used to rate ease of use.|||||||||||||||||The mean rating of parent reported ease of us of the mattress technology was 6.04 (SE = 0.15).|||
91752028|NCT02739321|183396991|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
91752029|NCT02558400|183396992|SUPERIORITY|To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints|||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
91506948|NCT00782210|182884881|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8456|STANDARD_ERROR_OF_MEAN|0.1467||0.3342|TWO_SIDED|95.0|0.6015|1.1889|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1889|0.6015|0.3342
91752030|NCT02558400|183396992|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
91752031|NCT02230683|183397000|SUPERIORITY_OR_OTHER||within group change|-1.14|STANDARD_DEVIATION|4.57||0.257|TWO_SIDED|95.0|-3.16|0.89|||Paired t-test||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||0.89|-3.16|0.257
91752032|NCT02230683|183397000|SUPERIORITY_OR_OTHER||within group change|1.9|STANDARD_DEVIATION|3.15||0.1174|TWO_SIDED|95.0|-0.52|4.32|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup||4.32|-0.52|0.1174
91752033|NCT02230683|183397000|SUPERIORITY_OR_OTHER||within group change|-3.67|STANDARD_DEVIATION|4.05||0.0025|TWO_SIDED|95.0|-5.88|-1.46|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup||-1.46|-5.88|0.0025
91752034|NCT02230683|183397001|SUPERIORITY_OR_OTHER||within group change|-0.22||||0.026|TWO_SIDED|95.0|-0.42|-0.03|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||-0.03|-0.42|0.026
91752035|NCT02230683|183397001|SUPERIORITY_OR_OTHER||within group change|-0.46||||0.001|TWO_SIDED|95.0|-0.72|-0.21|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-0.21|-0.72|0.001
91752036|NCT02230683|183397001|SUPERIORITY_OR_OTHER||within group change|-0.04||||0.72|TWO_SIDED|95.0|-0.26|0.18|||ANCOVA|||Statistical Analysis for the median change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||0.18|-0.26|0.72
91752037|NCT02230683|183397002|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-21.0||||0.105|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||13|-60|0.105
91752038|NCT02230683|183397002|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-52.5||||0.016|TWO_SIDED|95.0|-109.0|-6.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-6|-109|0.016
91752039|NCT02230683|183397002|SUPERIORITY_OR_OTHER||Hodges-Lehmann|12.0||||0.839|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||13|-60|0.839
91752040|NCT02230683|183397003|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0084|TWO_SIDED|95.0|-7.0|0.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Alanine Aminotransferase (ALT) from Baseline to Day 28/EOT||0|-7|0.0084
91752041|NCT02230683|183397004|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0131|TWO_SIDED|95.0|-7.0|-1.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Aspartate Aminotransferase (AST) from Baseline to Day 28/EOT||-1|-7|0.0131
91752042|NCT02230683|183397005|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-772.0||||0.003|TWO_SIDED|95.0|-1188.0|-19.0|||Wilcoxon (Mann-Whitney)||The estimated value is the ratio for the difference from baseline.|Statistical Analysis for the median change in concentration of Caspase 3/7 Relative Light Units from baseline to Day 28/EOT||-19|-1188|0.003
91752043|NCT00131456|183397098|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Regression, Logistic|||Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.||||<0.01
91752044|NCT02936284|183397109|SUPERIORITY||Mean Difference (Net)|0.196||||0.016|TWO_SIDED||||||Mixed Models Analysis|mixed effect regression model including covariates: child sex, child birth weight, breastfeeding duration, percent class attendance and covid grouping|difference between music and play group change|||||0.016
91752045|NCT02936284|183397110|SUPERIORITY||Mean Difference (Net)|29.9||||0.7|TWO_SIDED||||||Mixed Models Analysis||music group vs. play group baseline to 24 months|mixed effect regression analysis, unstructured covariance, no covariates. Reporting group x time interaction||||0.70
91752046|NCT02936284|183397111|SUPERIORITY||Mean Difference (Net)|0.073||||0.54|TWO_SIDED||||||Mixed Models Analysis||increase in weight for length z-score for music group|mixed-effect regression analysis with covariates: child sex, birth weight, breastfeeding duration, percent class attendance and covid categories||||0.540
91506949|NCT00782210|182884882|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.655|STANDARD_ERROR_OF_MEAN|0.2664||0.2985|TWO_SIDED|95.0|0.2947|1.4556|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.4556|0.2947|0.2985
91506950|NCT00782210|182884882|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1211|STANDARD_ERROR_OF_MEAN|0.4103||0.755|TWO_SIDED|95.0|0.5464|2.3003|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.3003|0.5464|0.7550
91506951|NCT00782210|182884883|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8081|STANDARD_ERROR_OF_MEAN|0.163||0.2911|TWO_SIDED|95.0|0.5438|1.2008|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.2008|0.5438|0.2911
91752047|NCT01610596|183397112|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91752048|NCT01187004|183397142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|significant level for inclusion at the univariate analysis was p\<0.05.||Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.||||<0.05
91752049|NCT01187004|183397143|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.199|||<|0.001|TWO_SIDED|95.0|1.129|1.272|||Wilcoxon (Mann-Whitney)|||||1.272|1.129|<0.001
91752050|NCT01479595|183397208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.514||||0.005|TWO_SIDED|90.0|-0.811|-0.217|||Mixed Models Analysis|||||-0.217|-0.811|0.005
91752051|NCT02120365|183397219|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|1.986||0.867|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Medication dose was a within-subjects factor (crossover design)||||0.867
91752052|NCT02120365|183397220|SUPERIORITY||Mean Difference (Final Values)|5.514|STANDARD_ERROR_OF_MEAN|3.038||0.071|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models, medication was a within-subjects factor||||0.071
91752053|NCT02120365|183397221|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|2.905||0.667|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models||||0.667
91752054|NCT02120365|183397222|SUPERIORITY||Mean Difference (Final Values)|2.242|STANDARD_ERROR_OF_MEAN|1.393||0.285|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|||||0.285
91752055|NCT02120365|183397223|SUPERIORITY||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.408||0.843|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Mixed Models||||.843
91752056|NCT02120365|183397224|SUPERIORITY||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|2.07||0.691|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|We report the main effect of dose on the outcome measure||||.691
91506952|NCT00782210|182884883|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8485|STANDARD_ERROR_OF_MEAN|0.1686||0.4086|TWO_SIDED|95.0|0.5743|1.2535|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2535|0.5743|0.4086
91752057|NCT01726673|183397225|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|302.0||||0.256|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.256
91752058|NCT01726673|183397225|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|222.0||||0.222|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.222
91752059|NCT01726673|183397226|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U Value|251.5||||1|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||1.0
91752060|NCT01726673|183397226|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|208.5||||0.592|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.592
91752061|NCT01726673|183397227|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|270.5||||0.68|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.680
91752062|NCT01726673|183397227|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|187.5||||0.837|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.837
91752063|NCT01344629|183397228|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|100.9||||||90.0|97.7|104.2||No statistical test|ANOVA|||||104.2|97.7|
91752064|NCT01344629|183397229|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|97.2||||||90.0|87.2|108.3||No statistical test|ANOVA|||||108.3|87.2|
91752065|NCT01344629|183397230|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|101.7||||||90.0|98.3|105.2||No statistical test|ANOVA|||||105.2|98.3|
91752066|NCT01344629|183397231|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|110.1||||||90.0|95.8|124.4||No statistical test|ANOVA|||||124.4|95.8|
91752067|NCT01344629|183397232|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|91.4||||||90.0|85.6|97.6||No statistical test|ANOVA|||||97.6|85.6|
91752068|NCT01344629|183397233|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.4||||||90.0|102.4|116.8||No statistical test|ANOVA|||||116.8|102.4|
91752069|NCT01344629|183397234|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.0||||||90.0|101.5|117.1||No statistical test|ANOVA|||||117.1|101.5|
91752070|NCT02305849|183397256|SUPERIORITY||Percent Difference|36.9|||<|0.001|TWO_SIDED|95.0|26.7|47.0||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||47.0|26.7|<0.001
91752071|NCT02305849|183397256|SUPERIORITY||Percent difference|42.6|||<|0.001|TWO_SIDED|95.0|32.6|52.6||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||52.6|32.6|<0.001
91752072|NCT02305849|183397257|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
91752073|NCT02305849|183397257|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
91752074|NCT02305849|183397259|SUPERIORITY||Percent Difference|22.2|||<|0.001|TWO_SIDED|95.0|13.8|30.7||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||30.7|13.8|<0.001
91752075|NCT02305849|183397259|SUPERIORITY||Percent Difference|38.3|||<|0.001|TWO_SIDED|95.0|29.3|47.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||47.3|29.3|<0.001
91752076|NCT02305849|183397261|SUPERIORITY||Percent Difference|9.7|||<|0.001|TWO_SIDED|95.0|3.8|15.6||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||15.6|3.8|<0.001
91752077|NCT02305849|183397261|SUPERIORITY||Percent Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.9|28.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.5|13.9|<0.001
91752078|NCT02305849|183397263|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
91752079|NCT02305849|183397263|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
91752080|NCT02305849|183397264|SUPERIORITY|||||||0.018|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.018
91752081|NCT02305849|183397264|SUPERIORITY|||||||0.002|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.002
91752082|NCT02305849|183397264|SUPERIORITY|||||||0.039|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.039
91752083|NCT02305849|183397264|SUPERIORITY|||||||0.006|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.006
91752084|NCT02305849|183397265|SUPERIORITY|||||||0.036|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||0.036
91752085|NCT02305849|183397265|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||<0.001
91752086|NCT02305849|183397265|SUPERIORITY|||||||0.013|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||0.013
91752087|NCT02305849|183397265|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||<0.001
91752088|NCT02305849|183397266|SUPERIORITY||Percent Difference|21.3|||<|0.001|TWO_SIDED|95.0|10.0|32.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||32.6|10.0|<0.001
91752089|NCT02305849|183397266|SUPERIORITY||Percent Difference|26.8|||<|0.001|TWO_SIDED|95.0|15.7|37.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||37.9|15.7|<0.001
91752090|NCT02305849|183397266|SUPERIORITY||Percent Difference|21.5|||<|0.001|TWO_SIDED|95.0|10.2|32.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||32.9|10.2|<0.001
91752091|NCT02305849|183397266|SUPERIORITY||Percent Difference|26.4|||<|0.001|TWO_SIDED|95.0|15.2|37.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||37.6|15.2|<0.001
91752092|NCT02305849|183397267|SUPERIORITY||LS Mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.46|-0.97||No multiplicity adjustment.|ANCOVA|Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.97|-1.46|<0.001
91752093|NCT02305849|183397267|SUPERIORITY||LS Mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.85|-1.33||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.33|-1.85|<0.001
91752094|NCT02305849|183397269|SUPERIORITY||LS Mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.44|-0.94||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.94|-1.44|<0.001
91752095|NCT02305849|183397269|SUPERIORITY||LS Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.89|-1.36||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.36|-1.89|<0.001
91752096|NCT02305849|183397271|SUPERIORITY||LS Mean difference|-5.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-6.9|-3.5||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-3.5|-6.9|<0.001
91752097|NCT02305849|183397271|SUPERIORITY||LS Mean difference|-7.2|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-5.6|-8.9|<0.001
91752098|NCT02305849|183397273|SUPERIORITY||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.3|-2.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-2.6|-5.3|<0.001
91752099|NCT02305849|183397273|SUPERIORITY||LS Mean difference|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-6.9|-4.3||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-4.3|-6.9|<0.001
91752100|NCT02305849|183397275|SUPERIORITY||Percent Difference|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||32.3|15.1|<0.001
91752101|NCT02305849|183397275|SUPERIORITY||Percent Difference|27.4|||<|0.001|TWO_SIDED|95.0|18.6|36.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||36.2|18.6|<0.001
91752102|NCT02305849|183397277|SUPERIORITY||Percent Difference|10.4|||<|0.001|TWO_SIDED|95.0|4.3|16.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||16.5|4.3|<0.001
91506953|NCT01610791|182884890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in ALT from Baseline to Week 24||||<0.001
91506954|NCT01610791|182884890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in AST from Baseline to Week 24||||<0.001
91506955|NCT01610791|182884891|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Diffrence in total cholesterol from baseline to Week 24||||<0.001
91506956|NCT01610791|182884891|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in LDL cholesterol from baseline to Week 24||||<0.001
91506957|NCT04304001|182884911|SUPERIORITY||||||<|0.05|||||||Chi-squared|||For each arm, the proportion of participants who receive colorectal cancer screening by 12 months was computed. The chi-square test was used to compare the two treatment arms for screening receipt. If the proportion of participants receiving colorectal cancer screening in the intervention arm is at least 15% higher than that in the control arm, the intervention was determined to be effective.||||<0.05
91506958|NCT04304001|182884912|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the knowledge scale to compare differences between the intervention and control arms. Since knowledge was a continuous variable,the values between study arms were compared using two-sample independent t-tests.||||<0.05
91532454|NCT00550173|182941603|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.99||||0.959|TWO_SIDED|95.0|0.7|1.4||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Secondary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||1.40|0.70|0.959
91532455|NCT00550173|182941604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||<0.001
91532456|NCT00550173|182941604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.031|TWO_SIDED|95.0|1.07|4.09|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||4.09|1.07|0.031
91532457|NCT00550173|182941604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.68|||<|0.001|TWO_SIDED|95.0|3.19|18.48|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||18.48|3.19|<0.001
91752103|NCT02305849|183397277|SUPERIORITY||Percent Difference|16.9|||<|0.001|TWO_SIDED|95.0|10.0|23.9||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||23.9|10.0|<0.001
91752104|NCT02305849|183397279|SUPERIORITY||Percent Difference|34.7|||<|0.001|TWO_SIDED|95.0|25.1|44.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||44.2|25.1|<0.001
91752105|NCT02305849|183397279|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.0|55.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||55.0|36.0|<0.001
91752106|NCT02305849|183397281|SUPERIORITY||Percent Difference|20.3|||<|0.001|TWO_SIDED|95.0|12.5|28.1||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.1|12.5|<0.001
91752107|NCT02305849|183397281|SUPERIORITY||Percent Difference|31.5|||<|0.001|TWO_SIDED|95.0|23.1|40.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||40.0|23.1|<0.001
91752108|NCT02305849|183397283|SUPERIORITY||LS Mean Difference|-1.597|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.948|-1.247||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.||Treatment Difference vs Placebo||-1.247|-1.948|<0.001
91506959|NCT04304001|182884913|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the self-efficacy scale to compare differences between the intervention and control arms. Since self-efficacy was a continuous variable, the values between study arms were compared using two-sample independent t-tests.||||<0.05
91506960|NCT04164901|182884914|SUPERIORITY||Cox Proportional Hazard|0.39|||<|1e-07|TWO_SIDED|95.0|0.27|0.56|||Kaplan-Meier|||||0.56|0.27|<0.0000001
91506961|NCT04164901|182884917|SUPERIORITY||Odds Ratio (OR)|4.88||||0.003|TWO_SIDED|95.0|1.56|15.25|||Cochran-Mantel-Haenszel||Odds ratio was calculated with placebo as the control (denominator).|||15.25|1.56|0.003
91752109|NCT02305849|183397283|SUPERIORITY||LS Mean Difference|-1.458|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.852|-1.065||No multiplicity adjustment.|ANCOVA|||Treatment Difference vs Placebo||-1.065|-1.852|<0.001
91752110|NCT02305849|183397285|SUPERIORITY||LS Mean Difference|-17.89|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-21.61|-14.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-14.17|-21.61|<0.001
91752111|NCT02305849|183397285|SUPERIORITY||LS Mean Difference|-20.61|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|TWO_SIDED|95.0|-24.67|-16.56||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-16.56|-24.67|<0.001
91752112|NCT02305849|183397287|SUPERIORITY||Percent Difference|33.0|||<|0.001|TWO_SIDED|95.0|23.7|42.2||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||42.2|23.7|<0.001
91752113|NCT02305849|183397287|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.2|54.8||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||54.8|36.2|<0.001
91752114|NCT02305849|183397289|SUPERIORITY||Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|32.3|52.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||52.5|32.3|<0.001
91506962|NCT04164901|182884924|SUPERIORITY||Cox Proportional Hazard|0.35||||2.4e-07|TWO_SIDED|95.0|0.23|0.54|||Kaplan-Meier|||||0.54|0.23|0.00000024
91506963|NCT05358821|182884932|SUPERIORITY||Mean Difference|3.3657|STANDARD_ERROR_OF_MEAN|0.2539|<|0.0001|TWO_SIDED|95.0|2.8566|3.8749|||T-test||Difference was calculated as HP - HD.|||3.8749|2.8566|<0.0001
91506964|NCT04609020|182884977|SUPERIORITY||Mean Difference (Final Values)|46.6|STANDARD_DEVIATION|23.61|<|0.0001|ONE_SIDED|97.5|40.58|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||40.58|<0.0001
91506965|NCT04609020|182884978|SUPERIORITY||Mean Difference (Final Values)|35.3|STANDARD_DEVIATION|22.36|<|0.0001|ONE_SIDED|97.5|29.61|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||29.61|<0.0001
91506966|NCT04609020|182884979|SUPERIORITY||Mean Difference (Final Values)|27.6|STANDARD_DEVIATION|23.23|<|0.0001|ONE_SIDED|97.5|21.5|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||21.50|<0.0001
91506967|NCT04609020|182884980|SUPERIORITY||Mean Difference (Final Values)|22.9|STANDARD_DEVIATION|20.56|<|0.0001|ONE_SIDED|97.5|17.65|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||17.65|<0.0001
91506968|NCT04609020|182884981|SUPERIORITY||Mean Difference (Final Values)|43.1|STANDARD_DEVIATION|22.25|<|0.0001|ONE_SIDED|97.5|37.48|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||37.48|<0.0001
91532458|NCT00550173|182941604|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.27||||0.004|TWO_SIDED|95.0|0.11|0.66|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.66|0.11|0.004
91532459|NCT00550173|182941605|SUPERIORITY_OR_OTHER|||||||0.194|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.194
91532460|NCT00550173|182941605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.747|TWO_SIDED|95.0|0.69|1.67|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.67|0.69|0.747
91532461|NCT00550173|182941605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.168|TWO_SIDED|95.0|0.49|1.13|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.13|0.49|0.168
91532462|NCT00550173|182941605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.094|TWO_SIDED|95.0|0.94|2.21|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.21|0.94|0.094
91532463|NCT00550173|182941607|SUPERIORITY_OR_OTHER|||||||0.306|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.306
91532464|NCT00550173|182941607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.127|TWO_SIDED|95.0|0.87|3.18|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||3.18|0.87|0.127
91532465|NCT00550173|182941607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.318|TWO_SIDED|95.0|0.72|2.71|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.71|0.72|0.318
91532466|NCT00550173|182941607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.599|TWO_SIDED|95.0|0.63|2.22|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.22|0.63|0.599
91506969|NCT02107599|182884986|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Asymptotic Z-test|||||||0.0001
91506970|NCT02107599|182884987|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0060
91506971|NCT02107599|182884987|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.1229
91506972|NCT02107599|182884987|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0260
91506973|NCT02462967|182885017|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
91506974|NCT02462967|182885017|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
91532467|NCT00550173|182941608|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.013
91532468|NCT00550173|182941608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.007|TWO_SIDED|95.0|0.41|0.87||Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.87|0.41|0.007
91532469|NCT00550173|182941608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.62|1.38|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.38|0.62|0.700
91532470|NCT00550173|182941608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.94|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.94|0.44|0.023
91532471|NCT00550173|182941609|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Cox|||||||0.040
91506975|NCT02462967|182885018|SUPERIORITY|||||||0.447|||||||ANCOVA|||||||0.447
91506976|NCT02462967|182885018|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
91506977|NCT02462967|182885019|SUPERIORITY|||||||0.522|||||||ANCOVA|||||||0.522
91506978|NCT02462967|182885019|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
91506979|NCT02462967|182885020|SUPERIORITY|||||||0.943|||||||ANCOVA|||||||0.943
91506980|NCT02462967|182885020|SUPERIORITY|||||||0.492|||||||ANCOVA|||||||0.492
91506981|NCT02462967|182885021|SUPERIORITY|||||||0.832|||||||ANCOVA|||||||0.832
91506982|NCT02462967|182885021|SUPERIORITY|||||||0.558|||||||ANCOVA|||||||0.558
91506983|NCT02462967|182885022|SUPERIORITY|||||||0.362|||||||ANCOVA|||||||0.362
91506984|NCT02462967|182885022|SUPERIORITY|||||||0.602|||||||ANCOVA|||||||0.602
91506985|NCT02462967|182885023|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||0.633
91506986|NCT02462967|182885023|SUPERIORITY|||||||0.814|||||||Chi-squared|||||||0.814
91506987|NCT02272413|182885025|EQUIVALENCE|The null hypothesis was to be rejected in favor of equivalence if the 2-sided 90% confidence interval (CI) for the ratio in best ORR between the treatments was entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|90.0|0.7697|0.9506|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9506|0.7697|
91506988|NCT02272413|182885025|EQUIVALENCE|Additional analysis of the primary endpoint was performed for Japan according to a local protocol amendment Japan. For the submission in Japan, to conclude on equivalence, the 2-sided 95% CI for the ratio of best ORR between the treatments had to be entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|95.0|0.7543|0.97|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9700|0.7543|
91506989|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.99|1.37|||Score exact method|||At least 1 AE selected for comparability assessment, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.37|0.99|
91506990|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.88|1.88|||Score exact method|||Infusion reactions, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.88|0.88|
91506991|NCT02272413|182885026|OTHER||Risk Ratio|1.2|||||TWO_SIDED|95.0|0.64|2.32|||Score exact method|||Thromboembolic events, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.32|0.64|
91506992|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.51|2.76|||Score exact method|||Febrile neutropenia, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.76|0.51|
91506993|NCT02272413|182885026|OTHER||Risk Ratio (RR)|3.43|||||TWO_SIDED|95.0|0.79|32.82|||Score exact method|||Gastrointestinal perforations, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||32.82|0.79|
91532472|NCT00550173|182941609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.241|TWO_SIDED|95.0|0.27|1.38|||Regression, Cox|||||1.38|0.27|0.241
91532473|NCT00550173|182941609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32||||0.011|TWO_SIDED|95.0|0.14|0.78|||Regression, Cox|||||0.78|0.14|0.011
91532474|NCT00550173|182941609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.128|TWO_SIDED|95.0|0.83|4.36|||Regression, Cox|||||4.36|0.83|0.128
91506994|NCT02272413|182885026|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.66|1.39|||Score exact method|||Hypertension, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.39|0.66|
91506995|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.57|||Score exact method|||Proteinuria, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.57|0.74|
91506996|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.28|10.79|||Score exact method|||Pulmonary haemorrhage, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||10.79|0.28|
91532475|NCT01345292|182941611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.44|STANDARD_ERROR_OF_MEAN|1.556|<|0.001|TWO_SIDED|95.0|8.37|14.5||If Sensodyne is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.50|8.37|<0.001
91532476|NCT01345292|182941611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|5.24|11.42||If Potassium Oxalate Mouth Rinse is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.42|5.24|<0.001
91532477|NCT01345292|182941612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|1.45|4.65||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.65|1.45|<0.001
91532478|NCT01345292|182941612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.818||0.004|TWO_SIDED|95.0|0.8|4.02||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.02|0.80|0.004
91752115|NCT02305849|183397289|SUPERIORITY||Percent Difference|49.3|||<|0.001|TWO_SIDED|95.0|39.7|58.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||58.9|39.7|<0.001
91752116|NCT02305849|183397291|SUPERIORITY||Percent Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.1|27.3|||Fisher Exact|No multiplicity adjustment.|CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||27.3|12.1|<0.001
91752117|NCT02305849|183397291|SUPERIORITY||Percent Difference|30.4|||<|0.001|TWO_SIDED|95.0|22.0|38.7||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||38.7|22.0|<0.001
91752118|NCT02305849|183397293|SUPERIORITY||Percent Difference|42.5|||<|0.001|TWO_SIDED|95.0|32.3|52.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||52.6|32.3|<0.001
91752119|NCT02305849|183397293|SUPERIORITY||Percent Difference|47.0|||<|0.001|TWO_SIDED|95.0|37.1|56.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||56.9|37.1|<0.001
91506997|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.88|1.74|||Score exact method|||Other hemorrhages, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.74|0.88|
91506998|NCT02272413|182885026|OTHER||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.47|3.57|||Score excat method|||Wound healing complications/ abscesses/ fistulas, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||3.57|0.47|
91752120|NCT02305849|183397295|SUPERIORITY||Percent Difference|5.2||||0.011|TWO_SIDED|95.0|1.0|9.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||9.5|1.0|0.011
91752121|NCT02305849|183397295|SUPERIORITY||Percent Difference|9.3|||<|0.001|TWO_SIDED|95.0|4.1|14.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||14.6|4.1|<0.001
91506999|NCT02272413|182885027|OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|1.02|1.45|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.45|1.02|
91507000|NCT02272413|182885028|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.51|1.00|
91507001|NCT02272413|182885029|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.88|1.48|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.48|0.88|
91507002|NCT02872116|182885031|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|98.4|0.59|0.86|||Log Rank|||||0.86|0.59|<0.0001
91507003|NCT02872116|182885032|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|98.0|0.56|0.81|||Log Rank|||||0.81|0.56|<0.0001
91507004|NCT03552575|182885040|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.19|TWO_SIDED|95.0|-4.8|1.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||1.0|-4.8|0.19
91507005|NCT03552575|182885041|SUPERIORITY||Ratio of adjusted geometric means|0.85||||0.31|TWO_SIDED|95.0|0.63|1.16|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.16|0.63|0.31
91507006|NCT03552575|182885042|SUPERIORITY||Ratio of adjusted geometric means|0.87||||0.41|TWO_SIDED|95.0|0.62|1.22|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.22|0.62|0.41
91507007|NCT03552575|182885043|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.1|TWO_SIDED|95.0|-6.8|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-6.8|0.10
91507008|NCT03552575|182885044|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.29|TWO_SIDED|95.0|-6.6|2.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||2.0|-6.6|0.29
91507009|NCT03552575|182885045|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-2.0|0.9|||Regression, Linear|adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.9|-2.0|0.46
91507010|NCT03552575|182885046|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.16|TWO_SIDED|95.0|-3.5|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-3.5|0.16
91507011|NCT03552575|182885047|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
91507012|NCT01052545|182885049|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.|Regression, Logistic|to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.||||||<0.05
91507013|NCT01052545|182885055|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||We used χ2 test, Fisher's exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.|Regression, Logistic|||||||<0.05
91507014|NCT03792672|182885056|SUPERIORITY||Least square mean (LSM) difference|115.0|STANDARD_ERROR_OF_MEAN|144.0||0.4278|TWO_SIDED|90.0|-128.0|359.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||359|-128|0.4278
91507015|NCT03792672|182885056|SUPERIORITY||LSM difference|338.0|STANDARD_ERROR_OF_MEAN|147.0||0.0269|TWO_SIDED|90.0|90.5|585.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||585|90.5|0.0269
91507016|NCT03792672|182885057|SUPERIORITY||LSM difference|-0.388|STANDARD_ERROR_OF_MEAN|0.582||0.5089|TWO_SIDED|90.0|-1.37|0.595||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.595|-1.37|0.5089
91507017|NCT03792672|182885057|SUPERIORITY||LSM difference|-0.209|STANDARD_ERROR_OF_MEAN|0.581||0.7208|TWO_SIDED|90.0|-1.19|0.773||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.773|-1.19|0.7208
91507018|NCT03792672|182885058|SUPERIORITY||LSM difference|14.0|STANDARD_ERROR_OF_MEAN|17.1||0.4174|TWO_SIDED|90.0|-14.8|42.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||42.8|-14.8|0.4174
91507019|NCT03792672|182885058|SUPERIORITY||LSM difference|15.1|STANDARD_ERROR_OF_MEAN|17.1||0.3832|TWO_SIDED|90.0|-25.3|31.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||31.5|-25.3|0.3832
91507020|NCT03792672|182885058|SUPERIORITY||LSM difference|-0.326|STANDARD_ERROR_OF_MEAN|4.09||0.9368|TWO_SIDED|90.0|-7.23|6.58||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||6.58|-7.23|0.9368
91507021|NCT03792672|182885058|SUPERIORITY||LSM difference|3.71|STANDARD_ERROR_OF_MEAN|4.16||0.379|TWO_SIDED|90.0|-3.32|10.7||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||10.7|-3.32|0.3790
91507022|NCT03792672|182885058|SUPERIORITY||LSM difference|7.36|STANDARD_ERROR_OF_MEAN|6.41||0.258|TWO_SIDED|90.0|-3.44|18.2||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||18.2|-3.44|0.2580
91507023|NCT03792672|182885058|SUPERIORITY||LSM difference|9.36|STANDARD_ERROR_OF_MEAN|6.41||0.1524|TWO_SIDED|90.0|-1.45|20.2|||Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||20.2|-1.45|0.1524
91507024|NCT03792672|182885058|SUPERIORITY||LSM difference|17.2|STANDARD_ERROR_OF_MEAN|7.21||0.022|TWO_SIDED|90.0|5.06|29.4||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||29.4|5.06|0.0220
91507025|NCT03792672|182885058|SUPERIORITY||LSM difference|9.58|STANDARD_ERROR_OF_MEAN|7.23||0.1927|TWO_SIDED|90.0|-2.59|21.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||21.8|-2.59|0.1927
91507026|NCT03792672|182885059|SUPERIORITY||LSM difference|-5.65|STANDARD_ERROR_OF_MEAN|9.59||0.559|TWO_SIDED|90.0|-21.8|10.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||10.5|-21.8|0.5590
91752122|NCT02305849|183397297|SUPERIORITY|No multiplicity adjustment.|Percent Difference|6.4||||0.003|TWO_SIDED|95.0|1.8|11.0|||Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||11.0|1.8|0.003
91507027|NCT03792672|182885059|SUPERIORITY||LSM difference|-16.1|STANDARD_ERROR_OF_MEAN|9.72||0.1049|TWO_SIDED|90.0|-32.5|0.242|||Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||0.242|-32.5|0.1049
91507028|NCT03792672|182885059|SUPERIORITY||LSM difference|-16.7|STANDARD_ERROR_OF_MEAN|13.5||0.2238|TWO_SIDED|90.0|-39.4|6.06||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||6.06|-39.4|0.2238
91507029|NCT03792672|182885059|SUPERIORITY||LSM difference|-18.3|STANDARD_ERROR_OF_MEAN|13.6||0.1847|TWO_SIDED|90.0|-41.3|4.56|||Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||4.56|-41.3|0.1847
91507030|NCT00453999|182885062|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Log Rank|Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.||||||0.306
91507031|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507032|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507033|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507034|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507035|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507036|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507037|NCT00453999|182885063|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
91507038|NCT00453999|182885064|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Log Rank|||||||0.276
91507039|NCT00453999|182885066|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||Log Rank|||||||0.994
91507040|NCT00453999|182885067|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 12 hours||||>0.05
91752123|NCT02305849|183397297|SUPERIORITY||Percent Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.5|19.4||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||19.4|7.5|<0.001
91752124|NCT02305849|183397299|SUPERIORITY||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-13.84|-8.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-8.60|-13.84|<0.001
91752125|NCT02305849|183397299|SUPERIORITY||LS Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|-17.35|-11.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-11.98|-17.35|<0.001
91507041|NCT00453999|182885067|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 24 hours||||>0.05
91507042|NCT00453999|182885067|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 36 hours||||>0.05
91507043|NCT00453999|182885067|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 48 hours||||>0.05
91507044|NCT00453999|182885067|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 72 hours||||>0.05
91507045|NCT00453999|182885067|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 96 hours||||>0.05
91507046|NCT01907828|182885105|OTHER|||||||0.22|||||||Log Rank|||Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.||||0.22
91507047|NCT01907828|182885109|SUPERIORITY|||||||0.2766|||||||Paired Student's t-test|||||||0.2766
91507048|NCT01907828|182885110|SUPERIORITY|||||||0.7663|||||||Wilcoxon signed-rank test|||||||0.7663
91507049|NCT01907828|182885113|SUPERIORITY||Mean Difference (Final Values)|-5.86|STANDARD_DEVIATION|15.21||0.0849|TWO_SIDED|95.0|-12.61|0.88|||Paired Student's t-test|||Change in ASBP at 12 months||0.88|-12.61|0.0849
91507050|NCT01907828|182885113|SUPERIORITY||Mean Difference (Final Values)|-5.82|STANDARD_DEVIATION|7.45||0.0014|TWO_SIDED|95.0|-9.12|-2.52|||Paired Student's t-test|||Change in ADBP at 12 months||-2.52|-9.12|0.0014
91507051|NCT01907828|182885113|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_DEVIATION|19.21||0.5599|TWO_SIDED|95.0|-14.16|8.02|||Paired Student's t-test|||Change in ASBP at 12 months.||8.02|-14.16|0.5599
91507052|NCT01907828|182885113|SUPERIORITY||Mean Difference (Final Values)|-8.43|STANDARD_DEVIATION|9.42||0.0052|TWO_SIDED|95.0|-13.87|-2.99|||Paired Student's t-test|||Change in ADBP at 12 months||-2.99|-13.87|0.0052
91507053|NCT01907828|182885114|SUPERIORITY||Mean Difference (Final Values)|-5.71|STANDARD_DEVIATION|14.84||0.1326|TWO_SIDED|95.0|-13.34|1.93|||Paired Student's t-test|||Change in ASBP at 24 months||1.93|-13.34|0.1326
91507054|NCT01907828|182885114|SUPERIORITY||Mean Difference (Final Values)|-6.94|STANDARD_DEVIATION|6.06||0.0002|TWO_SIDED|95.0|-10.06|-3.83|||Paired Student's t-test|||Change in ADBP at 24 months||-3.83|-10.06|0.0002
91752126|NCT02305849|183397301|SUPERIORITY||LS Mean difference|-17.67|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-22.11|-13.22||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-13.22|-22.11|<0.001
91752127|NCT02305849|183397301|SUPERIORITY||LS Mean Difference|-24.09|STANDARD_ERROR_OF_MEAN|2.33|<|0.001||95.0|-28.66|-19.51||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-19.51|-28.66|<0.001
91752128|NCT02305849|183397303|SUPERIORITY||LS Mean Difference|-16.64|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-21.09|-12.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)||Treatment Difference vs Placebo||-12.19|-21.09|<0.001
91752129|NCT02305849|183397303|SUPERIORITY||LS Mean difference|-20.34|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-25.07|-15.61||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).||Treatment Difference vs Placebo||-15.61|-25.07|<0.001
91752130|NCT02305849|183397305|SUPERIORITY||LS Mean Difference|-17.19|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-22.0|-12.38||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-12.38|-22.00|<0.001
91752131|NCT02305849|183397305|SUPERIORITY||LS Mean difference|-20.89|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-25.8|-15.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-15.98|-25.80|<0.001
91507055|NCT01907828|182885114|SUPERIORITY||Mean Difference (Final Values)|-8.58|STANDARD_DEVIATION|12.41||0.0354|TWO_SIDED|95.0|-16.47|-0.7|||Paired Student's t-test|||Change in ASBP at 24 months||-0.70|-16.47|0.0354
91507056|NCT01907828|182885114|SUPERIORITY||Mean Difference (Final Values)|-10.33|STANDARD_DEVIATION|8.53||0.0015|TWO_SIDED|95.0|-15.75|-4.91|||Paired Student's t-test|||Change in ADBP at 24 months||-4.91|-15.75|0.0015
91507057|NCT01907828|182885115|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|24.4||0.5399|TWO_SIDED|95.0|-6.0|11.3|||Paired Student's t-test|||Change in OSBP at 12 months.||11.3|-6.0|0.5399
91507058|NCT01907828|182885115|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|11.8||0.8489|TWO_SIDED|95.0|-4.6|3.8|||Paired Student's t-test|||Change in Office Diastolic Blood Pressure (ODBP) at 12 months||3.8|-4.6|0.8489
91507059|NCT01907828|182885115|SUPERIORITY|Change in Office Systolic Blood Pressure (OSBP) at 12 months.|Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|30.0||0.7999|TWO_SIDED|95.0|-14.6|18.6|||Paired Student's t-test|||||18.6|-14.6|0.7999
91507060|NCT01907828|182885115|SUPERIORITY||Mean Difference (Final Values)|-5.4|STANDARD_DEVIATION|15.8||0.2076|TWO_SIDED|95.0|-14.2|3.4|||Paired Student's t-test|||Change in ODBP at 12 months||3.4|-14.2|0.2076
91507061|NCT01907828|182885116|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|22.3||0.882|TWO_SIDED|95.0|-7.9|9.1|||Paired Student's t-test|||Change in OSBP at 24 months||9.1|-7.9|0.8820
91507062|NCT01907828|182885116|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|11.0||0.8019|TWO_SIDED|95.0|-3.7|4.7|||Paired Student's t-test|||Change in ODBP at 24 months||4.7|-3.7|0.8019
91507063|NCT01907828|182885116|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|22.9||0.2177|TWO_SIDED|95.0|-4.8|19.6|||Paired Student's t-test|||Change in OSBP at 24 months||19.6|-4.8|0.2177
91752132|NCT02305849|183397308|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.36|-0.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.17|-0.36|<0.001
91752133|NCT02305849|183397308|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.48|-0.29||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.29|-0.48|<0.001
91507064|NCT01907828|182885116|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|15.5||0.4502|TWO_SIDED|95.0|-11.2|5.2|||Paired Student's t-test|||Change in ODBP at 24 months||5.2|-11.2|0.4502
91507065|NCT04414553|182885126|SUPERIORITY|||||||0.29||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This compares pre/post data.||||0.29
91507066|NCT04414553|182885127|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
91507067|NCT04414553|182885128|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
91507068|NCT04414553|182885129|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
91507069|NCT04414553|182885130|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
91507070|NCT01874262|182885131|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
91752134|NCT02305849|183397310|SUPERIORITY||LS Mean Difference|6.41|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED|95.0|4.09|8.74||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||8.74|4.09|<0.001
91752135|NCT02305849|183397310|SUPERIORITY||LS Mean Difference|8.61|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|6.36|10.86||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||10.86|6.36|<0.001
91752136|NCT02305849|183397312|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|1.21|4.18||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||4.18|1.21|<0.001
91752137|NCT02305849|183397312|SUPERIORITY||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|0.78||0.036|TWO_SIDED|95.0|0.11|3.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||3.19|0.11|0.036
91752138|NCT02305849|183397314|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|1.39||0.099|TWO_SIDED|95.0|-0.44|5.02||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||5.02|-0.44|0.099
91752139|NCT02305849|183397314|SUPERIORITY||LS Mean Difference|4.22|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|1.53|6.91||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||6.91|1.53|0.002
91752140|NCT02305849|183397316|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|2.43||0.879|TWO_SIDED|95.0|-5.16|4.42||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||4.42|-5.16|0.879
91752141|NCT02305849|183397316|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|2.05||0.377|TWO_SIDED|95.0|-5.86|2.23||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||2.23|-5.86|0.377
91752142|NCT02305849|183397318|SUPERIORITY||LS Mean Difference|-9.63|STANDARD_ERROR_OF_MEAN|3.5||0.007|TWO_SIDED|95.0|-16.54|-2.73||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.73|-16.54|0.007
91752143|NCT02305849|183397318|SUPERIORITY||LS Mean Difference|-14.17|STANDARD_ERROR_OF_MEAN|3.58|<|0.001|TWO_SIDED|95.0|-21.24|-7.1||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.10|-21.24|<0.001
91752144|NCT02305849|183397320|SUPERIORITY||LS Mean Difference|-9.43|STANDARD_ERROR_OF_MEAN|3.63||0.01|TWO_SIDED|95.0|-16.6|-2.25||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.25|-16.60|0.010
91752145|NCT02305849|183397320|SUPERIORITY||LS Mean Difference|-14.61|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-21.92|-7.31||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.31|-21.92|<0.001
91752146|NCT02305849|183397322|SUPERIORITY||LS Mean Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.23|-8.16||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-8.16|-18.23|<0.001
91507071|NCT01228747|182885151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-56.13|STANDARD_ERROR_OF_MEAN|6.15|<|0.0001|TWO_SIDED|95.0|-68.24|-44.02||Statistical testing was 2-sided, and was performed using a significance (α) level of 0.05.|ANCOVA|||"The statistical hypotheses, null hypothesis (H0) and alternate hypothesis (H1), are stated below:~H0: μLEV = μPBO vs. H1: μLEV ≠ μPBO~ANCOVA on the endpoint percentage change from Combined Baseline of GTC seizures per week using treatment and country as factors (categorical predictors) and Combined Baseline GTC seizure frequency per week as a covariate (a continuous predictor) where μLEV and μPBO are adjusted means for LEV and PBO, respectively."||-44.02|-68.24|<0.0001
91507072|NCT00537381|182885168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.728||||0.014|TWO_SIDED|95.0|1.112|2.686|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.686|1.112|0.014
91507073|NCT00537381|182885169|SUPERIORITY_OR_OTHER|||||||0.795|||||||Fisher Exact|||||||0.795
91507074|NCT00537381|182885170|SUPERIORITY_OR_OTHER|||||||0.018|||||||Fisher Exact|||||||0.018
91507075|NCT00537381|182885171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.476||||0.163|TWO_SIDED|95.0|0.853|2.522|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.522|0.853|0.163
91507076|NCT05544786|182885175|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.13|||||TWO_SIDED|90.0|102.77|124.53|||||The ratios (and 90% confidence Intervals \[CIs\]) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||124.53|102.77|
91752147|NCT02305849|183397322|SUPERIORITY||LS Mean Difference|-17.61|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-22.57|-12.66||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-12.66|-22.57|<0.001
91752148|NCT00355342|183397327|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|0.06|1.49|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status.|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|1.49|0.06|
91752149|NCT00355342|183397328|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.78|0.24|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|0.24|-0.78|
91752150|NCT00997425|183397329|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door approach behavior||||||0.098
91507077|NCT05544786|182885175|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.91|||||TWO_SIDED|90.0|110.75|134.2|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||134.20|110.75|
91507078|NCT05544786|182885175|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|125.49|||||TWO_SIDED|90.0|114.43|137.61|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||137.61|114.43|
91507079|NCT05544786|182885175|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.09|||||TWO_SIDED|90.0|110.42|132.79|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||132.79|110.42|
91507080|NCT05544786|182885176|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.62|||||TWO_SIDED|90.0|102.96|125.4|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||125.40|102.96|
91507081|NCT05544786|182885176|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.53|||||TWO_SIDED|90.0|111.02|135.22|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||135.22|111.02|
91507082|NCT05544786|182885176|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|126.55|||||TWO_SIDED|90.0|115.0|139.27|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||139.27|115.00|
91507083|NCT05544786|182885176|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.28|||||TWO_SIDED|90.0|111.11|134.57|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||134.57|111.11|
91532479|NCT01345292|182941613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.091||0.324|TWO_SIDED|95.0|-6.19|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.06|-6.19|0.324
91532480|NCT01345292|182941613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|2.093||0.035|TWO_SIDED|95.0|-8.56|-0.31||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.31|-8.56|0.035
91532481|NCT01345292|182941614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|STANDARD_ERROR_OF_MEAN|2.551|<|0.001|TWO_SIDED|95.0|-13.6|-3.52||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.52|-13.6|<0.001
91752151|NCT00997425|183397329|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door pass through behavior||||||0.045
91752152|NCT02481713|183397350|NON_INFERIORITY|All analyses were two-tailed with alpha set at 0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91752153|NCT02481713|183397351|SUPERIORITY||Risk Ratio (RR)|1.46||||0.0001|TWO_SIDED|95.0|1.25|1.69|||Regression, zero-inflated Poisson|||||1.69|1.25|.0001
91752154|NCT01527383|183397352|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
91752155|NCT01527383|183397353|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
91752156|NCT02575118|183397358|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||In one saliva sample collected before treatment, the BPA concentration was more than 100 times higher (11.6 ng/ml) than the mean value and more than 100 SD from the mean of the remaining 19 samples. This saliva sample was excluded from the statistical analysis because it was probably contaminated. One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points) were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
91752157|NCT02575118|183397359|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points), were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
91507084|NCT05544786|182885177|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|110.28|||||TWO_SIDED|90.0|99.01|122.82|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||122.82|99.01|
91507085|NCT05544786|182885177|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|140.97|||||TWO_SIDED|90.0|126.57|157.01|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||157.01|126.57|
91507086|NCT05544786|182885177|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|149.83|||||TWO_SIDED|90.0|132.86|168.96|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||168.96|132.86|
91507087|NCT05544786|182885177|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|147.05|||||TWO_SIDED|90.0|130.4|165.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||165.83|130.40|
91507088|NCT05544786|182885178|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|96.76|||||TWO_SIDED|90.0|87.31|107.23|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||107.23|87.31|
91507089|NCT05544786|182885178|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.86|||||TWO_SIDED|90.0|78.38|96.26|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||96.26|78.38|
91507090|NCT05544786|182885178|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|99.29|||||TWO_SIDED|90.0|87.39|112.8|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||112.80|87.39|
91507091|NCT05544786|182885178|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|79.29|||||TWO_SIDED|90.0|70.07|89.73|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||89.73|70.07|
91507092|NCT05544786|182885179|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|95.92|||||TWO_SIDED|90.0|86.45|106.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||106.44|86.45|
91507093|NCT05544786|182885179|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.5|||||TWO_SIDED|90.0|77.96|95.98|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||95.98|77.96|
91507094|NCT05544786|182885179|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|88.29|||||TWO_SIDED|90.0|72.97|106.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||106.83|72.97|
91507095|NCT05544786|182885179|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|77.49|||||TWO_SIDED|90.0|64.04|93.76|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||93.76|64.04|
91507096|NCT05544786|182885180|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|101.92|||||TWO_SIDED|90.0|87.71|118.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||118.44|87.71|
91507097|NCT05544786|182885180|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|92.4|||||TWO_SIDED|90.0|79.52|107.38|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||107.38|79.52|
91507098|NCT05544786|182885180|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|97.04|||||TWO_SIDED|90.0|78.4|120.1|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||120.10|78.40|
91532482|NCT01345292|182941614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.553|<|0.001|TWO_SIDED|95.0|-15.2|-5.13||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.13|-15.2|<0.001
91507099|NCT05544786|182885180|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|70.45|||||TWO_SIDED|90.0|56.92|87.19|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||87.19|56.92|
91507100|NCT05544786|182885181|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.5|||||TWO_SIDED|90.0|90.08|103.37|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.37|90.08|
91507101|NCT05544786|182885182|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.63|||||TWO_SIDED|90.0|90.13|103.59|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.59|90.13|
91507102|NCT05544786|182885183|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|98.15|||||TWO_SIDED|90.0|87.28|110.36|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.36|87.28|
91507103|NCT05544786|182885184|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|78.49|||||TWO_SIDED|90.0|72.42|85.07|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||85.07|72.42|
91507104|NCT05544786|182885185|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|87.77|||||TWO_SIDED|90.0|69.45|110.92|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.92|69.45|
91507105|NCT05544786|182885186|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|72.6|||||TWO_SIDED|90.0|56.87|92.68|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||92.68|56.87|
91507106|NCT04258605|182885203|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<.0001
91507107|NCT04258605|182885204|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
91507108|NCT04258605|182885205|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
91507109|NCT04258605|182885206|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
91507110|NCT00181961|182885213|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||.016
91507111|NCT04144166|182885268|OTHER||||||||||||||See above|||"Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.~Median value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds."|See above|||
91507112|NCT01481116|182885279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
91507113|NCT01481116|182885279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
91507114|NCT01481116|182885279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
91507115|NCT01481116|182885279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
91507116|NCT01481116|182885280|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.707||0.065|TWO_SIDED|95.0|-2.7|0.08||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||0.08|-2.70|0.065
91532483|NCT01345292|182941615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91|STANDARD_ERROR_OF_MEAN|2.271||0.032|TWO_SIDED|95.0|-9.38|-0.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.43|-9.38|0.032
91532484|NCT01345292|182941615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.288||0.136|TWO_SIDED|95.0|-7.93|1.09||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.09|-7.93|0.136
91752158|NCT01689350|183397360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.01|TWO_SIDED|95.0|1.76|14.14|||Chi-squared|||Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.||14.14|1.76|<0.01
91752159|NCT01689350|183397361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.05|TWO_SIDED|95.0|1.01|7.13|||Chi-squared|||||7.13|1.01|<0.05
91752160|NCT00554099|183397362|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-3.0|STANDARD_ERROR_OF_MEAN|1.69||0.3781|ONE_SIDED|90.0||-0.809|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||-0.809||0.3781
91507117|NCT01481116|182885280|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.678||0.034|TWO_SIDED|95.0|-2.78|-0.11||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||-0.11|-2.78|0.034
91507118|NCT00934544|182885384|SUPERIORITY_OR_OTHER||Kaplan-Meir estimate|28.1|STANDARD_DEVIATION|22.123|<|0.0001|TWO_SIDED|95.0|21.3|36.6|||Cochran-Mantel-Haenszel|||||36.6|21.3|<0.0001
91507119|NCT02643251|182885395|SUPERIORITY|||||||0.3361|||||||Mixed Models Analysis|||||||0.3361
91532485|NCT01345292|182941616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|2.508|<|0.001|TWO_SIDED|95.0|-16.1|-6.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.23|-16.1|<0.001
91532486|NCT01345292|182941616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.527|<|0.001|TWO_SIDED|95.0|-15.2|-5.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.25|-15.2|<0.001
91752161|NCT00554099|183397362|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|1.74||0.6285|ONE_SIDED|90.0||0.815|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||0.815||0.6285
91752162|NCT00554099|183397362|SUPERIORITY_OR_OTHER||Mean Difference vs. Asacol|1.6|STANDARD_ERROR_OF_MEAN|1.58||0.4365|ONE_SIDED|90.0||3.573|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||3.573||0.4365
91752163|NCT00554099|183397363|SUPERIORITY_OR_OTHER||Difference vs. Placebo|21.1|STANDARD_ERROR_OF_MEAN|12.53||0.0576|ONE_SIDED|90.0|5.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||5.1|0.0576
91752164|NCT00554099|183397363|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.8|STANDARD_ERROR_OF_MEAN|13.27||0.3248|ONE_SIDED|90.0|-10.2||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-10.2|0.3248
91752165|NCT00554099|183397363|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-14.4|STANDARD_ERROR_OF_MEAN|12.87||0.8596|ONE_SIDED|90.0|-30.8||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-30.8|0.8596
91752166|NCT00554099|183397364|SUPERIORITY_OR_OTHER||Difference vs. Placebo|16.7|STANDARD_ERROR_OF_MEAN|14.0||0.1266|ONE_SIDED|90.0|-1.3||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-1.3|0.1266
91752167|NCT00554099|183397364|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-20.8|STANDARD_ERROR_OF_MEAN|14.13||0.9288|ONE_SIDED|90.0|-38.9||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-38.9|0.9288
91507120|NCT00430092|182885445|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mantel Haenszel|||||||<0.0001
91507121|NCT01956110|182885446|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing pregnancy rate was demonstrated.|Treatment difference|-0.9|||||TWO_SIDED|95.0|-5.9|4.1||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% confidence interval (CI) derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.1|-5.9|
91752168|NCT00554099|183397364|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-37.5|STANDARD_ERROR_OF_MEAN|12.98||0.9962|ONE_SIDED|90.0|-54.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-54.1|0.9962
91752169|NCT00554099|183397365|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|2.784||0.3082|ONE_SIDED|90.0||2.196|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||2.196||0.3082
91752170|NCT00554099|183397365|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.083|STANDARD_ERROR_OF_MEAN|2.903||0.5113|ONE_SIDED|90.0||3.832|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.832||0.5113
91752171|NCT00554099|183397365|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.483|STANDARD_ERROR_OF_MEAN|2.836||0.6988|ONE_SIDED|90.0||5.145|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.145||0.6988
91752172|NCT00554099|183397366|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-0.428|STANDARD_ERROR_OF_MEAN|3.067||0.4448|ONE_SIDED|90.0||3.541|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.541||0.4448
91507122|NCT01956110|182885447|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing implantation rate was demonstrated.|Treatment difference|-0.6|||||TWO_SIDED|95.0|-6.1|4.8||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.8|-6.1|
91507123|NCT01956110|182885448|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.7|3.4||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||3.4|-6.7|
91507124|NCT01956110|182885449|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.4|||||TWO_SIDED|95.0|-7.0|4.2||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.2|-7.0|
91507125|NCT01956110|182885450|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.001||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=15 oocytes retrieved||||=0.001
91752173|NCT00554099|183397366|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.825|STANDARD_ERROR_OF_MEAN|3.151||0.6029|ONE_SIDED|90.0||4.903|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||4.903||0.6029
91752174|NCT00554099|183397366|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.253|STANDARD_ERROR_OF_MEAN|2.996||0.6615|ONE_SIDED|90.0||5.129|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.129||0.6615
91752175|NCT00554099|183397367|SUPERIORITY_OR_OTHER||Difference vs. Placebo|2.6|STANDARD_ERROR_OF_MEAN|4.2||0.7165|ONE_SIDED|90.0||7.9|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||7.9||0.7165
91752176|NCT00554099|183397367|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.4|STANDARD_ERROR_OF_MEAN|2.41||0.1708|ONE_SIDED|90.0||0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||0.6||0.1708
91752177|NCT00554099|183397367|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-5.0|STANDARD_ERROR_OF_MEAN|3.45||0.1039|ONE_SIDED|90.0||-0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||-0.6||0.1039
91752178|NCT00554099|183397368|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-7.5|STANDARD_ERROR_OF_MEAN|8.21||0.1907|ONE_SIDED|90.0||3.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||3.0||0.1907
91752179|NCT00554099|183397368|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-8.2|STANDARD_ERROR_OF_MEAN|8.4||0.173|ONE_SIDED|90.0||2.5|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||2.5||0.1730
91752180|NCT00554099|183397368|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-0.7|STANDARD_ERROR_OF_MEAN|7.61||0.4613|ONE_SIDED|90.0||9.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||9.0||0.4613
91752181|NCT00554099|183397369|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.9|STANDARD_ERROR_OF_MEAN|11.7||0.3983|ONE_SIDED|90.0||12.1|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||12.1||0.3983
91752182|NCT00554099|183397369|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.0|STANDARD_ERROR_OF_MEAN|12.66||0.6721|ONE_SIDED|90.0||22.2|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||22.2||0.6721
91752183|NCT00554099|183397369|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|8.9|STANDARD_ERROR_OF_MEAN|12.23||0.7703|ONE_SIDED|90.0||24.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||24.6||0.7703
91752184|NCT04240093|183397370|SUPERIORITY|This is a pilot intervention trial and was not powered to detect statistical significance.|Beta coefficient|-0.46|STANDARD_ERROR_OF_MEAN|0.33||0.17|TWO_SIDED|95.0|-1.11|0.2||a priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equations (GEE) with a poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.||0.20|-1.11|0.17
91752185|NCT04240093|183397371|SUPERIORITY|This pilot feasibility and acceptability study was not powered to detect a statistically significant effect.|Beta coefficient|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.09|2.72||a priori alpha p\<0.05|Generalized estimating equation (GEE)|Generalized estimating equations (GEE) with a Poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.||2.72|-3.09|0.90
91752186|NCT04240093|183397372|SUPERIORITY|As a pilot feasibility and acceptability trial, this study was not powered to detect a statistically significant effect.|Beta coefficient|-4.71|STANDARD_ERROR_OF_MEAN|2.05||0.02|TWO_SIDED|95.0|-8.72|-0.7||A priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equation (GEE) modeling with a binomial distribution, controlling for baseline values.||Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.||-0.70|-8.72|0.02
91752187|NCT02839902|183397373|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-17.147||||0.0004|TWO_SIDED|95.0|-26.344|-7.95|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-7.950|-26.344|0.0004
91752188|NCT02839902|183397373|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-9.774||||0.1141|TWO_SIDED|95.0|-21.986|2.439|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.||2.439|-21.986|0.1141
91752189|NCT02839902|183397373|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-10.246||||0.0248|TWO_SIDED|95.0|-19.143|-1.349|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-1.349|-19.143|0.0248
91507126|NCT01956110|182885450|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.002||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=20 oocytes retrieved||||=0.002
91507127|NCT01956110|182885451|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.291||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade)||||=0.291
91532487|NCT01345292|182941617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|2.012||0.533|TWO_SIDED|95.0|-5.22|2.71||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.71|-5.22|0.533
91532488|NCT01345292|182941617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.023||0.522|TWO_SIDED|95.0|-5.29|2.69||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.69|-5.29|0.522
91507128|NCT01956110|182885451|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.644||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe)||||=0.644
91507129|NCT01956110|182885451|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.005||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Preventive interventions||||=0.005
91507130|NCT01956110|182885451|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.046||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade) and/or preventive interventions||||=0.046
91507131|NCT01956110|182885451|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.019||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe) and/or preventive interventions||||=0.019
91507132|NCT01956110|182885452|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35- 37, and 38-40 years) as factors.|Odds Ratio (OR)|1.38|||=|0.302|TWO_SIDED|95.0|0.74|2.57||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison: Cycle cancelled due to poor response||2.57|0.74|=0.302
91507133|NCT01956110|182885452|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35-37, and 38-40 years) as factors.|Odds Ratio (OR)|0.42||||0.019|TWO_SIDED|95.0|0.2|0.9||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison:Triggering with GnRH agonist||0.9|0.2|0.019
91532489|NCT01345292|182941618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.331|<|0.001|TWO_SIDED|95.0|-13.1|-3.94||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.94|-13.1|<0.001
91507134|NCT01956110|182885453|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.692|||||||van Elteren|||Treatment comparison: Number of oocytes retrieved||||=0.692
91507135|NCT01956110|182885454|OTHER|"A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor.~A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor."|||||=|0.019||||||Inclusion of treatment provides a better fit to the data|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||The relation between ovarian response potential (AMH at screening) and probability of achieving the targeted response was modelled using logistic regression models.||||=0.019
91507136|NCT01956110|182885455|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.909|||||||van Elteren|||Treatment comparison: Number of metaphase II oocytes||||=0.909
91532490|NCT01345292|182941618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.13|STANDARD_ERROR_OF_MEAN|2.344||0.01|TWO_SIDED|95.0|-10.8|-1.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.51|-10.8|0.010
91532491|NCT01207908|182941626|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.53|TWO_SIDED|95.0|-37.1|20.1|||t-test, 2 sided|||||20.1|-37.1|0.53
91507137|NCT01956110|182885456|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).||||||0.53|||||||van Elteren|||Treatment comparison: Fertilisation rate||||0.53
91507138|NCT01956110|182885457|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.59|||||||van Elteren|||Treatment comparison: Number of embryos||||=0.59
91507139|NCT01956110|182885457|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.414|||||||van Elteren|||Treatment comparison: Good quality embryos||||=0.414
91507140|NCT01956110|182885458|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.344|||||||van Elteren|||Treatment comparison: Number of blastocysts||||= 0.344
91507141|NCT01956110|182885458|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.58|||||||van Elteren|||Treatment comparison: Good-quality blastocysts||||= 0.58
91507142|NCT01956110|182885459|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||<|0.001|||||||van Elteren|||Treatment comparison: Total gonadotropin dose||||<0.001
91507143|NCT01956110|182885460|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.062|||||||van Elteren|||Treatment comparison: Number of stimulation days||||=0.062
91752190|NCT02839902|183397373|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-11.511||||0.0047|TWO_SIDED|95.0|-19.34|-3.682|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-3.682|-19.340|0.0047
91507144|NCT01956110|182885461|EQUIVALENCE|Treatment groups were compared using a chi-square test.|||||=|0.178|||||||Chi-squared|||Treatment comparison: Investigator-requested gonadotropin dose adjustments||||=0.178
91507145|NCT01956110|182885467|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.32||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (any grade)||||0.320
91507146|NCT01956110|182885467|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.39||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (moderate/severe)||||0.390
91507147|NCT01166594|182885477|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91507148|NCT01633944|182885504|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.67||||0.0012|TWO_SIDED|95.0|-1.07|-0.26|||ANCOVA|||||-0.26|-1.07|0.0012
91752191|NCT02839902|183397374|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|9.499||||0.1826|TWO_SIDED|95.0|-4.623|23.622|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.||23.622|-4.623|0.1826
91752192|NCT02839902|183397375|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.066||||0.004|TWO_SIDED|95.0|0.356|1.776|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.||1.776|0.356|0.0040
91507149|NCT01633944|182885505|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||0.0012
91507150|NCT01633944|182885505|SUPERIORITY_OR_OTHER|||||||0.0754|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥50% pain reduction||||0.0754
91507151|NCT03354429|182885589|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.015|TWO_SIDED|95.0|0.71|0.96||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.96|0.71|0.015
91507152|NCT03354429|182885590|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.004|TWO_SIDED|95.0|0.68|0.93||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.93|0.68|0.004
91507153|NCT03354429|182885591|SUPERIORITY||Odds Ratio (OR)|0.98||||0.613|TWO_SIDED|95.0|0.89|1.07||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Logistic|NIHSS (National Institutes of Health Stroke Scale) score and history of stroke (yes/no) included as covariates|Placebo is the reference group (denominator)|||1.07|0.89|0.613
91507154|NCT03354429|182885592|OTHER||Hazard Ratio (HR)|3.99||||0.001|TWO_SIDED|95.0|1.74|9.14|||Regression, Cox||Placebo is the reference group (denominator)|||9.14|1.74|0.001
91507155|NCT03354429|182885593|OTHER||Hazard Ratio (HR)|3.66||||0.005|TWO_SIDED|95.0|1.48|9.02|||Regression, Cox||Placebo is the reference group (denominator)|||9.02|1.48|0.005
91507156|NCT03354429|182885594|OTHER||Hazard Ratio (HR)|3.27|||<|0.001|TWO_SIDED|95.0|1.67|6.43|||Regression, Cox||Placebo is the reference group (denominator)|||6.43|1.67|<0.001
91507157|NCT03354429|182885595|OTHER||Hazard Ratio (HR)|4.8|||<|0.001|TWO_SIDED|95.0|3.28|7.02|||Regression, Cox||Placebo is the reference group (denominator)|||7.02|3.28|<0.001
91532492|NCT01207908|182941627|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.78|-1.55|||t-test, 2 sided|||||-1.55|-3.78|<0.0001
91752193|NCT02839902|183397375|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.553||||0.4428|TWO_SIDED|95.0|-2.884|5.991|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.||5.991|-2.884|0.4428
91507158|NCT00386256|182885596|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
91507159|NCT00386256|182885597|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
91507160|NCT00654381|182885600|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.04|-0.7|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-0.7|-1.04|<0.0001
91507161|NCT00654381|182885600|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.05|-0.71|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-0.71|-1.05|<0.0001
91752194|NCT02839902|183397375|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.76||||0.057|TWO_SIDED|95.0|-0.024|1.544|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.||1.544|-0.024|0.0570
91752195|NCT02839902|183397375|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.838||||0.036|TWO_SIDED|95.0|0.057|1.62|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.||1.620|0.057|0.0360
91752196|NCT03688555|183397395|SUPERIORITY||LS means difference|0.76|STANDARD_ERROR_OF_MEAN|0.301|=|0.062|TWO_SIDED|95.0|-0.06|1.59||All Nasal Polyp Score (NPS) values observed between baseline and Week 12 were included in the analysis. Changes from baseline to post-baseline visits in NPS were analyzed using a Mixed Model for Repeated Measurement (MMRM).|Mixed model for repeated measurements|||||1.59|-0.06|= 0.062
91752197|NCT03688555|183397396|SUPERIORITY||LS means difference|-3.98|STANDARD_ERROR_OF_MEAN|2.316|=|0.161|TWO_SIDED|95.0|-10.41|2.45|||ANCOVA|||||2.45|-10.41|= 0.161
91752198|NCT00394901|183397407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.262||95.0|-0.85|0.23|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.23|-0.85|0.262
91752199|NCT00394901|183397407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.002||95.0|-1.39|-0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.32|-1.39|0.002
91752200|NCT00394901|183397407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.019||95.0|-1.15|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.15|0.019
91752201|NCT00394901|183397408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.016||95.0|-1.16|-0.12|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.12|-1.16|0.016
91752202|NCT00394901|183397408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.008||95.0|-1.14|-0.17|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.14|0.008
91752203|NCT00394901|183397409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.1160
91752204|NCT00394901|183397409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0015
91752205|NCT00394901|183397409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0107||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0107
91752206|NCT00394901|183397410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51||||0.038||95.0|-0.99|-0.03|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.99|0.038
91752207|NCT00394901|183397410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
91752208|NCT00394901|183397410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.002||95.0|-1.19|-0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.19|0.002
91752209|NCT00394901|183397411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.048||95.0|-0.97|0.0|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.00|-0.97|0.048
91507162|NCT00654381|182885601|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0003|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||||-0.15|-0.49|0.0003
91507163|NCT00654381|182885601|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-0.21|-0.56|<0.0001
91507164|NCT00654381|182885605|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-25.4|-14.0|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-14.0|-25.4|<0.0001
91507165|NCT00654381|182885605|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-26.2|-14.7|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-14.7|-26.2|<0.0001
91507166|NCT00654381|182885606|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.1||0.0239|TWO_SIDED|95.0|-13.0|-0.9|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs Voglibose at week 26||-0.9|-13.0|0.0239
91507167|NCT00654381|182885606|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|3.1||0.0015|TWO_SIDED|95.0|-15.8|-3.8|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-3.8|-15.8|0.0015
91507168|NCT03778931|182885751|OTHER||Hazard Ratio (HR)|0.546||||0.0005|TWO_SIDED|95.0|0.387|0.768|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.768|0.387|0.0005
91507169|NCT03778931|182885752|OTHER||Hazard Ratio (HR)|0.697||||0.0018|TWO_SIDED|95.0|0.552|0.88|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.880|0.552|0.0018
91507170|NCT03778931|182885753|OTHER||Hazard Ratio (HR)|0.592||||0.0325|TWO_SIDED|95.0|0.361|0.958||The p-value was generated by using a two-sided stratified log-rank test.|Log Rank|||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.958|0.361|0.0325
91507171|NCT03778931|182885754|OTHER||Hazard Ratio (HR)|0.742||||0.0697|TWO_SIDED|95.0|0.536|1.025|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.|Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-wt), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).|||1.025|0.536|0.0697
91507172|NCT00915798|182885802|SUPERIORITY_OR_OTHER||F|0.56||||0.46|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD during abstinence in smokers and nonsmokers||||0.46
91507173|NCT00915798|182885802|SUPERIORITY_OR_OTHER||F|6.64||||0.012|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Diagnosis by smoking status interaction.|Parietal BOLD during abstinence in smokers and nonsmokers||||0.012
91507174|NCT00915798|182885802|SUPERIORITY_OR_OTHER||F|211.2||||0.04|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Main effect for smoking status.|Occipital BOLD during abstinence in smokers and nonsmokers.||||0.04
91532493|NCT01207908|182941628|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.53|TWO_SIDED|95.0|-1.26|2.38|||t-test, 2 sided|||||2.38|-1.26|0.53
91752210|NCT00394901|183397411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.47|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.47|<0.001
91752211|NCT00394901|183397411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|||<|0.001||95.0|-1.49|-0.56|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.49|<0.001
91752212|NCT00394901|183397412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.096||95.0|-0.89|0.07|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.07|-0.89|0.096
91752213|NCT00394901|183397412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||<|0.001||95.0|-1.44|-0.48|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.48|-1.44|<0.001
91752214|NCT00394901|183397412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.46|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.46|<0.001
91752215|NCT00394901|183397413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.505||95.0|-2.16|1.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.06|-2.16|0.505
91752216|NCT00394901|183397413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.86||||0.023||95.0|-3.46|-0.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-3.46|0.023
91752217|NCT00394901|183397413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.012||95.0|-3.56|-0.44|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.44|-3.56|0.012
91752218|NCT00394901|183397414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.349||95.0|-0.91|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.91|0.349
91532494|NCT02403674|182941652|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|3.537|||||TWO_SIDED|95.0|-1.951|9.026|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.026|-1.951|
91532495|NCT02403674|182941653|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-28.3|||<|0.001|TWO_SIDED|95.0|-34.0|-22.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Dizziness difference||-22.5|-34.0|<0.001
91532496|NCT02403674|182941653|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-13.5|||<|0.001|TWO_SIDED|95.0|-19.1|-7.9||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Sleep disorders and disturbances difference||-7.9|-19.1|<0.001
91532497|NCT02403674|182941653|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-3.8||||0.033|TWO_SIDED|95.0|-7.6|-0.3||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Altered sensorium difference||-0.3|-7.6|0.033
91532498|NCT02403674|182941654|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.815|||||TWO_SIDED|95.0|-2.412|10.042|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||10.042|-2.412|
91532499|NCT02403674|182941655|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|4.1|||||TWO_SIDED|95.0|-1.5|9.7|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.7|-1.5|
91532500|NCT02403674|182941656|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.268|||||TWO_SIDED|95.0|-3.057|9.593|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.593|-3.057|
91532501|NCT02403674|182941657|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.|Difference in mean %change from baseline|10.1|||||TWO_SIDED|95.0|-16.1|36.3|||||95% CIs were calculated based on t-distribution.|||36.3|-16.1|
91532502|NCT02403674|182941658|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA) was a positive value|Diff in mean % change from baseline|14.7|||||TWO_SIDED|95.0|-18.7|48.2|||||The 95% CI for mean difference in CD4 change was based on t-distribution.|||48.2|-18.7|
91532503|NCT02403674|182941659|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-13.0|-3.1|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-3.1|-13.0|
91532504|NCT02403674|182941660|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-3.6|||||TWO_SIDED|95.0|-6.9|-0.5|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-0.5|-6.9|
91532505|NCT02403674|182941661|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-2.5|||<|0.001|TWO_SIDED|95.0|-5.9|0.8||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Depression and suicide/self-injury difference||0.8|-5.9|<0.001
91507175|NCT00915798|182885802|SUPERIORITY_OR_OTHER||F|1.6||||0.22|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.22
91752219|NCT00394901|183397414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.024||95.0|-1.32|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.32|0.024
91752220|NCT00394901|183397414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.045||95.0|-1.21|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-1.21|0.045
91752221|NCT00394901|183397415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.441||95.0|-2.93|1.28|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.28|-2.93|0.441
91752222|NCT00394901|183397415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.55||||0.017||95.0|-4.64|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-4.64|0.017
91752223|NCT00394901|183397415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61||||0.012||95.0|-4.65|-0.56|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-4.65|0.012
91752224|NCT00394901|183397416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23||||0.47||95.0|-8.28|3.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.83|-8.28|0.470
91752225|NCT00394901|183397416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.04||||0.008||95.0|-14.0|-2.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.06|-14.0|0.008
91752226|NCT00394901|183397416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.43||||0.013||95.0|-13.3|-1.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-1.59|-13.3|0.013
91752227|NCT00394901|183397417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.178||95.0|-0.48|0.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.09|-0.48|0.178
91752228|NCT00394901|183397417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.003||95.0|-0.72|-0.15|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-0.72|0.003
91507176|NCT00915798|182885802|SUPERIORITY_OR_OTHER||F|0.43||||0.51|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Parietal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.51
91507177|NCT00915798|182885802|SUPERIORITY_OR_OTHER||F|0.16||||0.69|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Occipital BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.69
91507178|NCT00167934|182885805|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||< 0.0001
91532506|NCT02403674|182941661|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.5|0.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Psychosis and psychotic disorders difference||0.5|-2.5|<0.001
91752229|NCT00394901|183397417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.03||95.0|-0.59|-0.03|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.59|0.030
91752230|NCT00394901|183397418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.001||95.0|-1.23|-0.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.30|-1.23|0.001
91752231|NCT00394901|183397418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81||||0.001||95.0|-1.27|-0.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.34|-1.27|0.001
91507179|NCT00167934|182885806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
91507180|NCT04180020|182885810|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
91507181|NCT02442778|182885892|SUPERIORITY||Least Squares (LS) Mean Difference|0.4||||0.789|TWO_SIDED|95.0|-2.7|3.5||MMRM included fixed effect treatment,visit,treatment-by-visit,baseline,baseline-by-visit,baseline Neuropsychiatric Inventory Agitation/Aggression(NPI AA)(≤6 vs. \>6),falls risk assessment,baseline concomitant use of antipsychotic medications,cohorts.|MMRM|||||3.5|-2.7|0.789
91507182|NCT02442778|182885892|SUPERIORITY||LS Mean Difference|-2.0||||0.2|TWO_SIDED|95.0|-5.0|1.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.0|-5.0|0.200
91532507|NCT02403674|182941662|SUPERIORITY||Difference in mean %change from baseline|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.53|-6.49|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-6.49|-13.53|<0.0001
91507183|NCT02442778|182885893|SUPERIORITY||LS Mean Difference|0.1||||0.484|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.484
91507184|NCT02442778|182885893|SUPERIORITY||LS Mean Difference|-0.1||||0.704|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.704
91507185|NCT02442778|182885894|SUPERIORITY||LS Mean Difference|-0.3||||0.416|TWO_SIDED|95.0|-0.9|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.9|0.416
91507186|NCT02442778|182885894|SUPERIORITY||LS Mean Difference|-0.6||||0.066|TWO_SIDED|95.0|-1.3|0.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.0|-1.3|0.066
91507187|NCT02442778|182885895|SUPERIORITY||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.249
91507188|NCT02442778|182885895|SUPERIORITY||LS Mean Difference|-0.2||||0.199|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.199
91507189|NCT02442778|182885896|SUPERIORITY||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.7|0.7||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.7|-0.7|0.975
91507190|NCT02442778|182885896|SUPERIORITY||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-1.0|0.334
91507191|NCT02442778|182885897|SUPERIORITY||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.4|2.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.2|-2.4|0.934
91507192|NCT02442778|182885897|SUPERIORITY||LS Mean Difference|1.1||||0.342|TWO_SIDED|95.0|-1.2|3.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||3.4|-1.2|0.342
91507193|NCT02442778|182885898|SUPERIORITY||LS Mean Difference|0.0||||0.888|TWO_SIDED|95.0|-0.7|0.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.6|-0.7|0.888
91507194|NCT02442778|182885898|SUPERIORITY||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.3|-0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.1|-1.3|0.019
91507195|NCT02442778|182885899|SUPERIORITY||LS Mean Difference|0.6||||0.756|TWO_SIDED|95.0|-2.9|4.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||4.0|-2.9|0.756
91507196|NCT02442778|182885899|SUPERIORITY||LS Mean Difference|-3.6||||0.038|TWO_SIDED|95.0|-7.0|-0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.2|-7.0|0.038
91532508|NCT02403674|182941663|SUPERIORITY||Difference in mean %change from baseline|-17.02|||<|0.0001|TWO_SIDED|95.0|-20.89|-13.16|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-13.16|-20.89|<0.0001
91507197|NCT02442778|182885900|SUPERIORITY||LS Mean Difference|-0.1||||0.468|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.468
91507198|NCT02442778|182885900|SUPERIORITY||LS Mean Difference|-0.1||||0.158|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.158
91507199|NCT02442778|182885901|SUPERIORITY||LS Mean Difference|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.400
91752232|NCT00394901|183397418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.4|-0.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.49|-1.40|<0.001
91752233|NCT00394901|183397419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.001||95.0|-14.2|-3.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-3.61|-14.2|0.001
91752234|NCT00394901|183397419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.24||||0.002||95.0|-13.5|-2.99|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.99|-13.5|0.002
91752235|NCT00394901|183397419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.001||95.0|-16.5|-6.22|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-6.22|-16.5|<0.001
91752236|NCT00394901|183397420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29||||0.245||95.0|-2.95|11.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.54|-2.95|0.245
91752237|NCT00394901|183397420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.95||||0.417||95.0|-4.2|10.11|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.11|-4.20|0.417
91752238|NCT00394901|183397420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.007||95.0|2.67|16.74|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||16.74|2.67|0.007
91752239|NCT00394901|183397421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.76||95.0|-3.83|5.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.24|-3.83|0.760
91752240|NCT00394901|183397421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.754||95.0|-3.75|5.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.18|-3.75|0.754
91752241|NCT00394901|183397421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04||||0.641||95.0|-5.43|3.35|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.35|-5.43|0.641
91752242|NCT00394901|183397422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.955||95.0|-0.3|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.30|0.955
91752243|NCT00394901|183397422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27||||0.084||95.0|-0.04|0.58|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.58|-0.04|0.084
91752244|NCT00394901|183397422|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.17||95.0|-0.09|0.52|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.52|-0.09|0.170
91752245|NCT00394901|183397423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.01||||0.296||95.0|-3.52|11.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.55|-3.52|0.296
91752246|NCT00394901|183397423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3||||0.007||95.0|2.87|17.73|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.73|2.87|0.007
91507200|NCT02442778|182885901|SUPERIORITY||LS Mean Difference|-0.1||||0.566|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.566
91532509|NCT02403674|182941664|SUPERIORITY||Difference in mean %change from baseline|-23.44|||||TWO_SIDED|95.0|-27.57|-19.32|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-19.32|-27.57|
91752247|NCT00394901|183397423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.106||95.0|-1.29|13.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.30|-1.29|0.106
91752248|NCT00394901|183397424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.191||95.0|-1.97|9.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.83|-1.97|0.191
91752249|NCT00394901|183397424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.21|||<|0.001||95.0|5.41|17.02|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.02|5.41|<0.001
91752250|NCT00394901|183397424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.23|||<|0.001||95.0|8.5|19.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||19.95|8.50|<0.001
91507201|NCT02442778|182885902|SUPERIORITY||LS Mean Difference|0.0||||0.751|TWO_SIDED|95.0|-0.2|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-0.2|0.751
91507202|NCT02442778|182885902|SUPERIORITY||LS Mean Difference|-0.1||||0.32|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.320
91507203|NCT02442778|182885903|SUPERIORITY||LS Mean Difference|0.3||||0.782|TWO_SIDED|95.0|-1.8|2.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.4|-1.8|0.782
91507204|NCT02442778|182885903|SUPERIORITY||LS Mean Difference|0.0||||0.991|TWO_SIDED|95.0|-2.1|2.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.0|-2.1|0.991
91507205|NCT02442778|182885904|SUPERIORITY||LS Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.2|0.0|0.038
91507206|NCT02442778|182885904|SUPERIORITY||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.6|0.5||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.5|-0.6|0.911
91507207|NCT02442778|182885906|SUPERIORITY||LS Mean Difference|1.0||||0.236|TWO_SIDED|95.0|-0.6|2.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.6|-0.6|0.236
91507208|NCT02442778|182885906|SUPERIORITY||LS Mean Difference|0.3||||0.684|TWO_SIDED|95.0|-1.3|1.9||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.9|-1.3|0.684
91507209|NCT02641379|182885912|SUPERIORITY_OR_OTHER|||||||0.1002|||||||Chi-squared|||For Genotype I, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.1002
91507210|NCT02641379|182885912|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Chi-squared|||For Genotype I, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0184
91507211|NCT02641379|182885912|SUPERIORITY_OR_OTHER|||||||0.091|||||||Chi-squared|||For Genotype IV, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0910
91507212|NCT02641379|182885912|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||For Genotype IV, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||1.0000
91507213|NCT02641379|182885913|SUPERIORITY_OR_OTHER|||||||0.0021||||||The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype I.||||0.0021
91507214|NCT02641379|182885913|SUPERIORITY_OR_OTHER|||||||0.3031||||||The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype IV||||0.3031
91507215|NCT01165138|182885927|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.136||||0.002|TWO_SIDED|95.0|0.051|0.222|||ANCOVA|||||0.222|0.051|0.002
91507216|NCT01165138|182885927|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.087|0.258|||ANCOVA|||||0.258|0.087|<0.001
91507217|NCT01165138|182885927|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.036||||0.405|TWO_SIDED|95.0|-0.048|0.12|||ANCOVA|||||0.120|-0.048|0.405
91507218|NCT01165138|182885928|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.186||||0.003|TWO_SIDED|95.0|0.062|0.31|||ANCOVA|||||0.310|0.062|0.003
91507219|NCT01165138|182885928|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.302|||<|0.001|TWO_SIDED|95.0|0.178|0.426|||ANCOVA|||||0.426|0.178|<0.001
91507220|NCT01165138|182885928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.06|TWO_SIDED|95.0|-0.005|0.236|||ANCOVA|||||0.236|-0.005|0.060
91507221|NCT01644175|182885946|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-52.5|-39.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-39.3|-52.5|<0.0001
91532510|NCT02403674|182941665|SUPERIORITY||Difference in mean %change from baseline|-35.96|||||TWO_SIDED|95.0|-47.1|-24.82|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-24.82|-47.10|
91532511|NCT02403674|182941666|SUPERIORITY||Difference in mean %change from baseline|-6.47|||||TWO_SIDED|95.0|-7.97|-4.96|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-4.96|-7.97|
91532512|NCT03019458|182941678|SUPERIORITY|||||||0.084||||||The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p\<0.05.|Mixed Models Analysis|We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).||||||0.084
91752251|NCT00394901|183397425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03||||0.061||95.0|-8.25|0.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-8.25|0.061
91507222|NCT01644175|182885947|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.9|||<|0.0001|TWO_SIDED|95.0|-56.2|-43.6||Threshold for significance was ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-43.6|-56.2|<0.0001
91507223|NCT01644175|182885948|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.4|||<|0.0001|TWO_SIDED|95.0|-53.6|-41.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.3|-53.6|<0.0001
91507224|NCT01644175|182885949|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-55.3|<0.0001
91507225|NCT01644175|182885950|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-41.3|-30.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.3|-41.3|<0.0001
91507226|NCT01644175|182885951|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.0|-32.0||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.0|-43.0|<0.0001
91507227|NCT01644175|182885952|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.5|-31.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.4|-43.5|<0.0001
91532513|NCT01161160|182941694|NON_INFERIORITY|Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.|Adjusted GMT ratio|0.96|||||TWO_SIDED|95.0|0.73|1.26||||||To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.||1.26|0.73|
91532514|NCT01561079|182941737|SUPERIORITY_OR_OTHER|||||||0.001||||||The p values were not adjusted for multiplicity The a priori threshold = .05|Hierarchical Linear Modeling|The p-value was calculated||||||0.001
91532515|NCT01561079|182941738|SUPERIORITY_OR_OTHER||||||<|0.002|||||||Hierarchical Linear Modeling|||||||<.002
91752252|NCT00394901|183397425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.133||95.0|-7.37|0.98|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.98|-7.37|0.133
91507228|NCT01644175|182885953|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|||<|0.0001|TWO_SIDED|95.0|-46.4|-34.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.4|-46.4|<0.0001
91507229|NCT01644175|182885954|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-29.3|<0.0001
91507230|NCT01644175|182885955|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-43.7|-32.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.7|-43.7|<0.0001
91507231|NCT01644175|182885956|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.1|||<|0.0001|TWO_SIDED|95.0|-46.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-46.2|<0.0001
91507232|NCT01644175|182885957|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|95.0|-31.1|-21.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-31.1|<0.0001
91532516|NCT01561079|182941739|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Hierarchical Linear Modeling|||||||0.0001
91752253|NCT00394901|183397425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.24||95.0|-6.52|1.64|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.64|-6.52|0.240
91507233|NCT01644175|182885958|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|95.0|-51.6|-34.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.3|-51.6|<0.0001
91532517|NCT01561079|182941740|SUPERIORITY_OR_OTHER|||||||0.008|||||||Hierarchical Linear Modeling|The reported p-value was calculated||||||.008
91532518|NCT01561079|182941741|SUPERIORITY_OR_OTHER|||||||0.002|||||||Hierarchical Linear Modeling|||||||.002
91532519|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|25.0||||0.456|TWO_SIDED|95.0|-41.0|91.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||91.0|-41.0|0.456
91752254|NCT00394901|183397426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68||||0.2842||95.0|0.34|1.37|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.37|0.34|0.2842
91507234|NCT01644175|182885959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.5|||<|0.0001|TWO_SIDED|95.0|16.5|89.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||89.8|16.5|<0.0001
91507235|NCT01644175|182885960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|||<|0.0001|TWO_SIDED|95.0|20.6|121.0||Threshold for significance ≤ 0.05|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||121.0|20.6|<0.0001
91507236|NCT01644175|182885961|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.6|||<|0.0001|TWO_SIDED|95.0|-21.3|-7.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-7.9|-21.3|<0.0001
91752255|NCT00394901|183397426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89||||0.0577||95.0|0.98|3.66|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.66|0.98|0.0577
91752256|NCT00394901|183397426|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.1893||95.0|0.81|2.95|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.95|0.81|0.1893
91752257|NCT00394901|183397427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0466
91752258|NCT00394901|183397427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
91752259|NCT00394901|183397427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
91752260|NCT00394901|183397428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.3440
91752261|NCT00394901|183397428|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
91752262|NCT00394901|183397428|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
91752263|NCT00394901|183397429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.51||||0.057||95.0|-0.1|7.13|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.13|-0.10|0.057
91752264|NCT00394901|183397429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.67||95.0|-2.78|4.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.32|-2.78|0.670
91507237|NCT01644175|182885962|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0001|TWO_SIDED|95.0|3.6|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.0|3.6|0.0001
91507238|NCT01644175|182885963|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8699|TWO_SIDED|95.0|-8.3|7.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.0|-8.3|0.8699
91507239|NCT01495585|182885969|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||0.03
91507240|NCT01495585|182885969|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||<0.0001
91532520|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|74.7||||0.033|TWO_SIDED|95.0|6.0|143.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||143.4|6.0|0.033
91532521|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|30.6||||0.295|TWO_SIDED|95.0|-26.8|88.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||88.0|-26.8|0.295
91752265|NCT00394901|183397429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.04||||0.559||95.0|-2.45|4.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.53|-2.45|0.559
91752266|NCT00394901|183397430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.4||||0.004||95.0|3.01|15.78|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.78|3.01|0.004
91752267|NCT00394901|183397430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.67||||0.037||95.0|0.39|12.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.95|0.39|0.037
91752268|NCT00394901|183397430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.46||||0.643||95.0|-4.74|7.66|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.66|-4.74|0.643
91507241|NCT01495585|182885970|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91507242|NCT01495585|182885970|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
91507243|NCT01667978|182885974|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91507244|NCT00962104|182886139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.78|||<|0.001|TWO_SIDED|95.0|-7.66|-3.91||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline CAARS-Inv:SV 18-Item Total ADHD Symptom score .|ANCOVA|||||-3.91|-7.66|<0.001
91507245|NCT00962104|182886140|SUPERIORITY_OR_OTHER||Slope|4.76|||<|0.001|TWO_SIDED|95.0|1.97|7.56||First gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline AAQoL total score.||||7.56|1.97|<0.001
91507246|NCT00962104|182886141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.82||||0.289|TWO_SIDED|95.0|-5.2|1.56||Second gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Least Squares Mean difference between 2 treatment groups from Type III sum of squares analysis of covariance model:Change=treatment+country+baseline.||||1.56|-5.20|0.289
91507247|NCT00962104|182886142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.13|-4.22|||Mixed Models Analysis|||||-4.22|-8.13|<0.001
91752269|NCT00394901|183397431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.811||95.0|-4.5|5.75|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.75|-4.50|0.811
91507248|NCT00962104|182886143|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.21|-4.14|||Mixed Models Analysis|||||-4.14|-8.21|<0.001
91507249|NCT00962104|182886144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.59||||0.001|TWO_SIDED|95.0|-5.73|-1.45||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-1.45|-5.73|0.001
91507250|NCT00962104|182886144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.29|||<|0.001|TWO_SIDED|95.0|-9.28|-3.31||This is the p-value for the Raw MI score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-3.31|-9.28|<0.001
91507251|NCT00962104|182886144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.76|||<|0.001|TWO_SIDED|95.0|-14.75|-4.78||This is the p-value for the Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-4.78|-14.75|<0.001
91507252|NCT00962104|182886145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.93||||0.092|TWO_SIDED|95.0|-4.18|0.32||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.32|-4.18|0.092
91752270|NCT00394901|183397431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.07||||0.006||95.0|2.03|12.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.12|2.03|0.006
91507253|NCT00962104|182886145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.62||||0.272|TWO_SIDED|95.0|-4.52|1.28||This is the p-value for the Raw MI Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.28|-4.52|0.272
91752271|NCT00394901|183397431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.03||||0.047||95.0|0.06|10.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.00|0.06|0.047
91752272|NCT00394901|183397432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.013||95.0|1.1|9.5|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.50|1.10|0.013
91752273|NCT00394901|183397432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.82||||0.07||95.0|-0.31|7.96|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.96|-0.31|0.070
91752274|NCT00394901|183397432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.058||95.0|-0.13|8.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.00|-0.13|0.058
91752275|NCT00394901|183397433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43||||0.443||95.0|-3.79|8.65|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.65|-3.79|0.443
91752276|NCT00394901|183397433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.41||||0.018||95.0|1.28|13.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.54|1.28|0.018
91752277|NCT00394901|183397433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.549||95.0|-4.18|7.85|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.85|-4.18|0.549
91752278|NCT00394901|183397434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.15||||0.075||95.0|-0.63|12.92|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.92|-0.63|0.075
91752279|NCT00394901|183397434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41||||0.111||95.0|-1.25|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-1.25|0.111
91507254|NCT00962104|182886145|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.55||||0.153|TWO_SIDED|95.0|-8.43|1.32||This is the p-value for the Raw Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.32|-8.43|0.153
91507255|NCT00962104|182886146|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.27||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-0.27|-0.67|<0.001
91752280|NCT00394901|183397434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.02||||0.366||95.0|-3.55|9.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.60|-3.55|0.366
91752281|NCT00394901|183397435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.64||||0.039||95.0|0.29|11.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.00|0.29|0.039
91752282|NCT00394901|183397435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.006||95.0|2.14|12.69|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.69|2.14|0.006
91752283|NCT00394901|183397435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.15||||0.117||95.0|-1.05|9.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.34|-1.05|0.117
91752284|NCT00394901|183397436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.99||||0.154||95.0|-1.5|9.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05||9.49|-1.50|0.154
91752285|NCT00394901|183397436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.99||||0.012||95.0|1.58|12.4|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.40|1.58|0.012
91752286|NCT00394901|183397436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.76||||0.079||95.0|-0.56|10.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.08|-0.56|0.079
91752287|NCT00394901|183397437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.6451||95.0|0.45|3.59|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.59|0.45|0.6451
91752288|NCT00394901|183397437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.56||||0.0745||95.0|0.91|7.19|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.19|0.91|0.0745
91752289|NCT00394901|183397437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.01||||0.1787||95.0|0.73|5.58|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.58|0.73|0.1787
91752290|NCT00394901|183397438|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.0732||95.0|0.93|5.52|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.52|0.93|0.0732
91507256|NCT00962104|182886147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed using an analysis of variance (ANOVA) with term for treatment and country.|ANOVA|||||||<0.001
91507257|NCT00962104|182886148|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.869|TWO_SIDED|95.0|-0.71|0.6||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.60|-0.71|0.869
91507258|NCT00962104|182886149|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.87|TWO_SIDED|95.0|-0.59|0.5||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.50|-0.59|0.870
91507259|NCT03274986|182886150|SUPERIORITY||Least Squares Mean Difference|-0.164|STANDARD_ERROR_OF_MEAN|0.0168|<|0.001|TWO_SIDED|95.0|-0.197|-0.131||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.131|-0.197|<0.001
91507260|NCT03274986|182886151|NON_INFERIORITY|Non-Inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.0127|||ONE_SIDED|95.0||0.073||The hypothesis test was based on a two-sample t-test, with a type I error rate of 0.05, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.|||0.073||
91507261|NCT03274986|182886152|OTHER||Difference in depth of focus|0.54|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Difference in depth of focus (DFT015 - SN60WF)|||||
91507262|NCT03274986|182886156|SUPERIORITY||Least Squares Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|-0.197|-0.115||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.115|-0.197|<0.001
91507263|NCT03274986|182886157|OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|9.65|27.37|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||27.37|9.65|
91507264|NCT00603746|182886161|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.275|||<|0.001||95.0|0.18|0.37|||ANCOVA|||||0.370|0.180|<0.001
91752291|NCT00394901|183397438|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.0353||95.0|1.07|6.53|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.53|1.07|0.0353
91507265|NCT00603746|182886161|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.272|||<|0.001|TWO_SIDED|95.0|0.178|0.367|||ANCOVA|||||0.367|0.178|<0.001
91752292|NCT00394901|183397438|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.5||||0.0393||95.0|1.05|5.96|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.96|1.05|0.0393
91752293|NCT00394901|183397439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.227||95.0|-0.78|0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-0.78|0.227
91752294|NCT00394901|183397439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|||<|0.001||95.0|-1.34|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.34|<0.001
91752295|NCT00394901|183397439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||<|0.001||95.0|-1.4|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.40|<0.001
91752296|NCT00394901|183397440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.577||95.0|-0.62|0.35|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.35|-0.62|0.577
91752297|NCT00394901|183397440|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.39|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.39|-1.35|<0.001
91752298|NCT00394901|183397440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
91752299|NCT00394901|183397441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.275||95.0|-0.75|0.21|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.21|-0.75|0.275
91752300|NCT00394901|183397441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|||<|0.001||95.0|-1.46|-0.5|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.50|-1.46|<0.001
91752301|NCT00394901|183397441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.28|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.22|0.002
91752302|NCT00394901|183397442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.334||95.0|-0.72|0.25|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.25|-0.72|0.334
91752303|NCT00394901|183397442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.001||95.0|-1.38|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.38|<0.001
91752304|NCT00394901|183397442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.006||95.0|-1.14|-0.19|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.006
91507266|NCT00603746|182886161|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.264|||<|0.001|TWO_SIDED|95.0|0.171|0.357|||ANCOVA|||||0.357|0.171|<0.001
91507267|NCT00603746|182886161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.131|0.32|||ANCOVA|||||0.320|0.131|<0.001
91532522|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|44.4||||0.188|TWO_SIDED|95.0|-21.8|110.6||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||110.6|-21.8|0.188
91752305|NCT00394901|183397443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.53||95.0|-0.64|0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.33|-0.64|0.530
91752306|NCT00394901|183397443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
91507268|NCT00603746|182886161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.105|0.291|||ANCOVA|||||0.291|0.105|<0.001
91507269|NCT01524627|182886190|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
91507270|NCT01524627|182886190|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91507271|NCT05627518|182886191|OTHER||Ratio|1.9954|||<|0.0001|TWO_SIDED|95.0|1.8399|2.1641|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|The Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.1641|1.8399|<0.0001
91507272|NCT05627518|182886191|OTHER||Ratio|2.125|||<|0.0001|TWO_SIDED|95.0|1.9664|2.2963|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|AUClast: Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.2963|1.9664|<0.0001
91507273|NCT05627518|182886192|OTHER|Ratio|Ratio|2.3167|||<|0.0001|TWO_SIDED|95.0|2.0922|2.5652|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.5652|2.0922|<0.0001
91507274|NCT05627518|182886193|OTHER|Ratio|Ratio|0.757|||<|0.0001|TWO_SIDED|95.0|0.7009|0.8177|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8177|0.7009|<0.0001
91532523|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|38.8||||0.187|TWO_SIDED|95.0|-18.9|96.5||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||96.5|-18.9|0.187
91752307|NCT00394901|183397443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.017||95.0|-1.05|-0.1|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.05|0.017
91752308|NCT00394901|183397444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.392||95.0|-0.7|0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.27|-0.70|0.392
91752309|NCT00394901|183397444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.35|<0.001
91752310|NCT00394901|183397444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.016||95.0|-1.06|-0.11|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.11|-1.06|0.016
91752311|NCT00394901|183397445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.364||95.0|-0.71|0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.26|-0.71|0.364
91752312|NCT00394901|183397445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||<|0.001||95.0|-1.39|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.39|<0.001
91752313|NCT00394901|183397445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.031||95.0|-1.0|-0.05|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.00|0.031
91752314|NCT00394901|183397446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.326||95.0|-0.73|0.24|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.24|-0.73|0.326
91752315|NCT00394901|183397446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.43|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.43|<0.001
91752316|NCT00394901|183397446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.007||95.0|-1.13|-0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.13|0.007
91752317|NCT00394901|183397447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.241||95.0|-0.78|0.2|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.20|-0.78|0.241
91752318|NCT00394901|183397447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.001||95.0|-1.34|-0.37|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.37|-1.34|0.001
91752319|NCT00394901|183397447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.01||95.0|-1.1|-0.15|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-1.10|0.010
91752320|NCT00394901|183397448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.281||95.0|-0.76|0.22|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.22|-0.76|0.281
91752321|NCT00394901|183397448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
91752322|NCT00394901|183397448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.012||95.0|-1.09|-0.14|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.09|0.012
91507275|NCT05627518|182886193|OTHER|Ratio|Ratio|0.7684|||<|0.0001|TWO_SIDED|95.0|0.7102|0.8313|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8313|0.7102|<0.0001
91507276|NCT05627518|182886194|OTHER|Ratio|Ratio|0.2548|||<|0.0001|TWO_SIDED|95.0|0.1999|0.3247|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3247|0.1999|<0.0001
91507277|NCT05627518|182886195|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
91507278|NCT05627518|182886195|OTHER|Ratio|Ratio|3.5277|||<|0.0001|TWO_SIDED|95.0|2.9076|4.2799|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||4.2799|2.9076|<0.0001
91532524|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.9||||0.801|TWO_SIDED|95.0|-77.8|60.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg|||60.1|-77.8|0.801
91752323|NCT02076399|183397462|SUPERIORITY||Risk Difference (RD)|17.6||||0.0261|TWO_SIDED|95.0|7.2|28.1|||Fisher Exact|||||28.1|7.2|0.0261
91752324|NCT02076399|183397467|SUPERIORITY||Risk Difference (RD)|-0.01||||0.6642|TWO_SIDED|95.0|-0.01|0.0||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.0|-0.01|0.6642
91752325|NCT02076399|183397468|SUPERIORITY||Risk Difference (RD)|0.15||||0.3365|TWO_SIDED|95.0|-0.2|0.5||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.5|-0.2|0.3365
91752326|NCT05260333|183397469|OTHER||correlation coefficient|0.81||||0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0001
91752327|NCT02008357|183397472|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.26|TWO_SIDED|95.0|-0.816|0.22|||Natural Cubic Spline (NCS) method|||||0.220|-0.816|0.260
91752328|NCT02008357|183397474|SUPERIORITY||LS Mean difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.28||0.1|TWO_SIDED|95.0|-0.089|1.02|||Natural Cubic Spline (NCS) method|||||1.020|-0.089|0.100
91752329|NCT02008357|183397476|SUPERIORITY||LS Mean difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34||0.082|TWO_SIDED|95.0|-1.265|0.076|||Natural Cubic Spline (NCS) method|||||0.076|-1.265|0.082
91752330|NCT02008357|183397478|SUPERIORITY||LS Mean difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0073|<|0.001|TWO_SIDED|95.0|-0.057|-0.028|||ANCOVA|||||-0.028|-0.057|<0.001
91752331|NCT02008357|183397479|SUPERIORITY||LS Mean difference (Final Values)|3.239|STANDARD_ERROR_OF_MEAN|32.8719||0.922|TWO_SIDED|95.0|-62.02|68.498|||ANCOVA|||Cerebrospinal fluid Tau Protein Immunoassay||68.498|-62.020|0.922
91752332|NCT02008357|183397479|SUPERIORITY||LS Mean difference (Final Values)|-0.965|STANDARD_ERROR_OF_MEAN|2.6535||0.717|TWO_SIDED|95.0|-6.241|4.311|||ANCOVA|||Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay||4.311|-6.241|0.717
91752333|NCT02008357|183397480|SUPERIORITY||LS Mean difference (Final Values)|12738.449|STANDARD_ERROR_OF_MEAN|998.7048|<|0.001|TWO_SIDED|95.0|10757.047|14719.851|||ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST||14719.851|10757.047|<0.001
91532525|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|35.2||||0.233|TWO_SIDED|95.0|-22.7|93.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||93.1|-22.7|0.233
91752334|NCT02008357|183397480|SUPERIORITY||LS Mean difference (Final Values)|996.411|STANDARD_ERROR_OF_MEAN|60.7404|<|0.001|TWO_SIDED|95.0|875.873|1116.948||p-value using ANCOVA model for endpoint measures: CHG = Baseline + APOE4 + AGE + Treatment.|ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST||1116.948|875.873|<0.001
91752335|NCT02008357|183397481|SUPERIORITY||LS Mean difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.0388||0.161|TWO_SIDED|95.0|-0.131|0.022|||ANCOVA|||Total hippocampal volume||0.022|-0.131|0.161
91752336|NCT02008357|183397481|SUPERIORITY||LS Mean difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.4513||0.437|TWO_SIDED|95.0|-0.535|1.236|||ANCOVA|||Total Lateral Ventricular Volume||1.236|-0.535|0.437
91752337|NCT03553498|183397491|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91752338|NCT03553498|183397492|SUPERIORITY|||||||0.989|||||||Chi-squared|||||||0.989
91752339|NCT03553498|183397493|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
91752340|NCT03553498|183397494|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
91752341|NCT01498185|183397495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|18.5425|||TWO_SIDED|95.0|-40.85|35.86||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||35.86|-40.85|
91752342|NCT01498185|183397495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|16.7228|||TWO_SIDED|95.0|-35.36|33.82||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||33.82|-35.36|
91752343|NCT01498185|183397495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.88|STANDARD_ERROR_OF_MEAN|17.1548|||TWO_SIDED|95.0|-42.21|28.45||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||28.45|-42.21|
91752344|NCT01498185|183397495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|18.4617|||TWO_SIDED|95.0|-39.22|37.16||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||37.16|-39.22|
91752345|NCT02032641|183397504|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||<0.05
91752346|NCT02032641|183397504|SUPERIORITY_OR_OTHER||||||>|0.1||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||>0.10
91752347|NCT02827500|183397529|SUPERIORITY||Odds Ratio, log|5.19||||0.002|TWO_SIDED|95.0|1.88|14.33|||Regression, Logistic|||||14.33|1.88|0.002
91752348|NCT02827500|183397530|SUPERIORITY|||||||0.011|||||||Regression, Linear|||||||0.011
91752349|NCT02827500|183397531|SUPERIORITY|||||||0.011|||||||Regression, Linear|||The null hypothesis tested was that there is no difference in change in heart rate between the treatment arms.||||0.011
91752350|NCT02827500|183397532|SUPERIORITY|||||||0.054||||||The apriori threshold for statistical significance is alpha=0.05.|Chi-squared, Corrected|The p-value is obtained using the F-test (combination of Chi-Squared tests) due to multiple imputation.||The null hypothesis tested was that there is no difference between the treatment arms in the proportion of patients with heart rate \< 70 BPM.||||0.054
91752351|NCT02827500|183397533|SUPERIORITY|||||||0.717|||||||Regression, Linear|||||||0.717
91752352|NCT02827500|183397534|SUPERIORITY|||||||0.784|||||||Regression, Linear|||||||0.784
91752353|NCT03343080|183397536|SUPERIORITY|||||||0.776|||||||Wilcoxon (Mann-Whitney)|||||||0.776
91752354|NCT03343080|183397537|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||4 hours post-extubation||||0.296
91752355|NCT01688921|183397560|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.12|0.88|
91752356|NCT01688921|183397561|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.21|0.96|
91752357|NCT01688921|183397562|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.83|1.06||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.06|0.83|
91532526|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|69.4||||0.003|TWO_SIDED|95.0|24.5|114.4|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||114.4|24.5|0.003
91507279|NCT05627518|182886196|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
91752358|NCT01688921|183397563|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.|Seroconversion Rate Difference|0.8|||||TWO_SIDED|95.0|-4.8|6.5||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||6.5|-4.8|
91752359|NCT01688921|183397564|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points|Seroconversion Rate Difference|1.3|||||TWO_SIDED|95.0|-4.5|7.1||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||7.1|-4.5|
91752360|NCT01688921|183397565|NON_INFERIORITY_OR_EQUIVALENCE|"Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.~The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively)."|Seroconversion Rate Difference|0.3|||||TWO_SIDED|95.0|-5.2|5.9||||||For a sample size of 550 per group each test has an individual power of \> 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||5.9|-5.2|
91752361|NCT01688921|183397566|NON_INFERIORITY_OR_EQUIVALENCE|Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91752362|NCT01688921|183397567|NON_INFERIORITY_OR_EQUIVALENCE|The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
91752363|NCT03697993|183397602|OTHER||Risk Difference (RD)|-18.0||||0.264|TWO_SIDED|95.0|-43.4|8.7|||Multiple imputation using Wald method|||||8.7|-43.4|0.264
91752364|NCT03697993|183397606|OTHER||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-26.2|24.3|||Fisher Exact|||||24.3|-26.2|1.000
91752365|NCT03697993|183397607|OTHER||Odds Ratio (OR)|0.9||||0.894|TWO_SIDED|95.0|0.3|2.5|||Proportional odds model using Wald test|||||2.5|0.3|0.894
91752366|NCT03697993|183397608|OTHER||Risk Difference (RD)|0.0||||0.973|TWO_SIDED|95.0|-26.3|25.3|||Multiple imputation using Wald method|||||25.3|-26.3|0.973
91752367|NCT04384107|183397609|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.1|||=|0.641|TWO_SIDED|95.0|-5.9|3.6|||Miettinen & Nurminen|||Injection site erythema||3.6|-5.9|= 0.641
91752368|NCT04384107|183397609|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2|||=|0.937|TWO_SIDED|95.0|-6.1|5.6|||Miettinen & Nurminen|||Injection site induration||5.6|-6.1|= 0.937
91752369|NCT04384107|183397609|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|7.1|||=|0.036|TWO_SIDED|95.0|0.5|13.8|||Miettinen & Nurminen|||Injection site pain||13.8|0.5|= 0.036
91752370|NCT04384107|183397609|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-4.0|||=|0.208|TWO_SIDED|95.0|-10.2|2.2|||Miettinen & Nurminen|||Injection site swelling||2.2|-10.2|= 0.208
91507280|NCT05627518|182886197|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4131|0.5867|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5867|0.4131|<0.0001
91507281|NCT05627518|182886197|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4047|0.5989|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5989|0.4047|<0.0001
91507282|NCT05627518|182886198|OTHER|Ratio|Ratio|0.2522|||<|0.0001|TWO_SIDED|95.0|0.198|0.3211|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing test formulation fed (treatment C) vs. reference formulation fasted (treatment B). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3211|0.1980|<0.0001
91507283|NCT02453113|182886204|SUPERIORITY||||||||||||||||||The statistical end point of the study will be the changes in density of CD11c+ dermal dendritic cells between two biopsies from a study subject where one sample is subjected to laser irradiation and the other is the control. For assessment of statistical significance, we will apply a paired sample t-test.|||
91752371|NCT04384107|183397610|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.4|||=|0.912|TWO_SIDED|95.0|-6.7|6.0|||Miettinen & Nurminen|||Decreased appetite||6.0|-6.7|= 0.912
91507284|NCT04013191|182886205|OTHER||Point Estimate|0.928|||||TWO_SIDED|90.0|0.725|1.19|||ANOVA|||The analysis of variance (ANOVA) model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.19|0.725|
91507285|NCT04013191|182886206|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.894|1.67|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.67|0.894|
91752372|NCT04384107|183397610|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|5.9|||=|0.108|TWO_SIDED|95.0|-1.3|13.0|||Miettinen & Nurminen|||Irritability||13.0|-1.3|= 0.108
91752373|NCT04384107|183397610|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.0|||=|0.792|TWO_SIDED|95.0|-6.4|8.4|||Miettinen & Nurminen|||Somnolence||8.4|-6.4|= 0.792
91752374|NCT04384107|183397610|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.3|||=|0.843|TWO_SIDED|95.0|-3.5|2.8|||Miettinen & Nurminen|||Urticaria||2.8|-3.5|= 0.843
91752375|NCT04384107|183397611|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
91752376|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
91752377|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.3|||<|0.001|TWO_SIDED|95.0|1.0|4.5|||Miettinen and Nurminen|||Serotype 3: Participants With IgG ≥0.35 μg/mL||4.5|1.0|< 0.001
91752378|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 4: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
91752379|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 5: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
91752380|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.2|||Miettinen and Nurminen|||Serotype 6A: Participants With IgG ≥0.35 μg/mL||0.2|-2.6|< 0.001
91752381|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-3.9|||<|0.001|TWO_SIDED|95.0|-6.9|-1.3|||Miettinen and Nurminen|||Serotype 6B: Participants With IgG ≥0.35 μg/mL||-1.3|-6.9|< 0.001
91752382|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 7F: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
91507286|NCT04013191|182886207|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.893|1.68|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.68|0.893|
91507287|NCT04013191|182886208|OTHER||Point Estimate|1.02|||||TWO_SIDED|90.0|0.829|1.26|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.26|0.829|
91752383|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 9V: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
91752384|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.9|1.1|||Miettinen and Nurminen|||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.9|< 0.001
91752385|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 18C: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
91752386|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 19A: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
91752387|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
91752388|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.8|||<|0.001|TWO_SIDED|95.0|-4.0|-0.2|||Miettinen and Nurminen|||Serotype 23F: Participants With IgG ≥0.35 μg/mL||-0.2|-4.0|< 0.001
91752389|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.0|||<|0.001|TWO_SIDED|95.0|0.4|4.3|||Miettinen and Nurminen|||Serotype 22F: Participants With IgG ≥0.35 μg/mL||4.3|0.4|<0.001
91752390|NCT04384107|183397612|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-6.8|||=|0.048|TWO_SIDED|95.0|-10.6|-3.5|||Miettinen and Nurminen|||Serotype 33F: Participants With IgG ≥0.35 μg/mL||-3.5|-10.6|= 0.048
91752391|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.55|0.67|||Linear model|||Serotype 1: IgG GMC Ratio||0.67|0.55|< 0.001
91752392|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.85|||<|0.001|TWO_SIDED|95.0|1.67|2.05|||Linear model|||Serotype 3: IgG GMC Ratio||2.05|1.67|< 0.001
91507288|NCT04013191|182886209|OTHER||Point Estimate|1.18|||||TWO_SIDED|90.0|0.908|1.53|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.53|0.908|
91507289|NCT02223767|182886312|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||||||0.025
91507290|NCT02223767|182886313|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|||||||0.08
91507291|NCT02822508|182886341|SUPERIORITY|||||||0.034|||||||Cochran-Mantel-Haenszel|||||||0.034
91507292|NCT00994448|182886349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.3|STANDARD_ERROR_OF_MEAN|8.6||0.08|TWO_SIDED|95.0|1.8|34.3|||t-test, 2 sided|||t test for mean of days retained in the bupropion versus placebo groups||34.3|1.8|0.08
91507293|NCT02704364|182886381|SUPERIORITY||Hodges-Lehmann estimate|-14.0|STANDARD_ERROR_OF_MEAN|21.4||0.434|TWO_SIDED|95.0|-68.0|28.0|||Wilcoxon (Mann-Whitney)|||||28.0|-68.0|0.434
91507294|NCT02704364|182886381|SUPERIORITY||Hodges-Lehmann estimate|13.0|STANDARD_ERROR_OF_MEAN|25.0||0.646|TWO_SIDED|95.0|-41.0|71.0|||Wilcoxon (Mann-Whitney)|||||71.0|-41.0|0.646
91752393|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93|||Linear model|||Serotype 4: IgG GMC Ratio||0.93|0.76|< 0.001
91752394|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.87|||Linear model|||Serotype 5: IgG GMC Ratio||0.87|0.69|< 0.001
91752395|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.56|||=|0.019|TWO_SIDED|95.0|0.5|0.63|||Linear model|||Serotype 6A: IgG GMC Ratio||0.63|0.50|= 0.019
91752396|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.59|||=|0.015|TWO_SIDED|95.0|0.51|0.68|||Linear model|||Serotype 6B: IgG GMC Ratio||0.68|0.51|= 0.015
91752397|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.75|0.94|||Linear model|||Serotype 7F: IgG GMC Ratio||0.94|0.75|< 0.001
91752398|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.97|||Linear model|||Serotype 9V: IgG GMC Ratio||0.97|0.78|< 0.001
91752399|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.66|0.85|||Linear model|||Serotype 14: IgG GMC Ratio||0.85|0.66|< 0.001
91752400|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.82|||Linear model|||Serotype 18C: IgG GMC Ratio||0.82|0.67|< 0.001
91752401|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.65|||<|0.001|TWO_SIDED|95.0|0.59|0.72|||Linear model|||Serotype 19A: IgG GMC Ratio||0.72|0.59|< 0.001
91752402|NCT04384107|183397613|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.69|0.82|||Linear model|||Serotype 19F: IgG GMC Ratio||0.82|0.69|< 0.001
91752403|NCT04384107|183397614|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|107.45|||||TWO_SIDED|95.0|96.18|120.03||||||Serotype 22F: IgG GMC Ratio||120.03|96.18|
91752404|NCT04384107|183397614|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|32.48|||||TWO_SIDED|95.0|27.72|38.05||||||Serotype 33F: IgG GMC Ratio||38.05|27.72|
91752405|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
91752406|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|3.3|||||TWO_SIDED|95.0|1.8|5.8||||||Serotype 3: Participants With IgG ≥0.35 μg/mL||5.8|1.8|
91532527|NCT01323660|182941762|SUPERIORITY_OR_OTHER||Least squares mean difference|65.8||||0.005|TWO_SIDED|95.0|20.3|111.3|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||111.3|20.3|0.005
91752407|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 4: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
91752408|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 5: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91507295|NCT01461096|182886408|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.35|TWO_SIDED|95.1|0.47|1.31||P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.|generalized log-rank test (Sun 1996)|The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.|qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.|||1.31|0.47|0.350
91507296|NCT04889625|182886422|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0085|||TWO_SIDED|95.0|-0.017|0.017|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Distance (4m)||0.017|-0.017|
91507297|NCT04889625|182886422|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.0108|||TWO_SIDED|95.0|-0.051|-0.008|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Intermediate (64cm)||-0.008|-0.051|
91752409|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752410|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6B: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752411|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 7F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752412|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 9V: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752413|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752414|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 18C: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91507298|NCT04889625|182886422|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.0129|||TWO_SIDED|95.0|-0.062|-0.011|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Near (40cm)||-0.011|-0.062|
91507299|NCT04889625|182886423|NON_INFERIORITY|This study was powered to demonstrate the primary hypotheses. However, the final sample size calculation was deemed large enough to test for Non-inferiority of the Test relative to the Control. A non-inferiority margin of -5 points was used.|least-square mean difference|6.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|2.0|10.5|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A (C3)- delefilcon A|||10.5|2.0|
91507300|NCT00404352|182886424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
91507301|NCT00404352|182886424|SUPERIORITY_OR_OTHER|||||||0.008|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.008
91507302|NCT00404352|182886424|SUPERIORITY_OR_OTHER|||||||0.009|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.009
91507303|NCT00404352|182886425|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
91752415|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752416|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
91752417|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.3|||||TWO_SIDED|95.0|-1.1|1.9||||||Serotype 23F: Participants With IgG ≥0.35 μg/mL||1.9|-1.1|
91752418|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|94.8|||||TWO_SIDED|95.0|91.8|96.7||||||Serotype 22F: Participants With IgG ≥0.35 μg/mL||96.7|91.8|
91752419|NCT04384107|183397615|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|88.5|||||TWO_SIDED|95.0|84.5|91.6||||||Serotype 33F: Participants With IgG ≥0.35 μg/mL||91.6|84.5|
91752420|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.53|||||TWO_SIDED|95.0|0.47|0.59||||||Serotype 1: IgG GMC Ratio||0.59|0.47|
91752421|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.9||||||Serotype 3: IgG GMC Ratio||1.90|1.53|
91752422|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05||||||Serotype 4: IgG GMC Ratio||1.05|0.80|
91752423|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.75||||||Serotype 5: IgG GMC Ratio||0.75|0.59|
91752424|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.56|0.73||||||Serotype 6A: IgG GMC Ratio||0.73|0.56|
91752425|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 6B: IgG GMC Ratio||0.84|0.65|
91752426|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.92||||||Serotype 7F: IgG GMC Ratio||0.92|0.71|
91752427|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94||||||Serotype 9V: IgG GMC Ratio||0.94|0.73|
91752428|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||Serotype 14: IgG GMC Ratio||0.96|0.74|
91752429|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||Serotype 18C: IgG GMC Ratio||1.14|0.87|
91752430|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92||||||Serotype 19A: IgG GMC Ratio||0.92|0.73|
91752431|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.75|0.94||||||Serotype 19F: IgG GMC Ratio||0.94|0.75|
91752432|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7||||||Serotype 23F: IgG GMC Ratio||0.70|0.52|
91752433|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|86.74|||||TWO_SIDED|95.0|77.61|96.95||||||Serotype 22F: IgG GMC Ratio||96.95|77.61|
91752434|NCT04384107|183397616|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|45.44|||||TWO_SIDED|95.0|40.07|51.54||||||Serotype 33F: IgG GMC Ratio||51.54|40.07|
91752435|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78||||||Serotype 1: OPA GMT Ratio||0.78|0.55|
91752436|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.23|1.59||||||Serotype 3: OPA GMT Ratio||1.59|1.23|
91752437|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1||||||Serotype 4: OPA GMT Ratio||1.10|0.85|
91752438|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Serotype 5: OPA GMT Ratio||1.04|0.80|
91752439|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 6A: OPA GMT Ratio||0.89|0.65|
91752440|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.95||||||Serotype 6B: OPA GMT Ratio||0.95|0.69|
91752441|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.95||||||Serotype 7F: OPA GMT Ratio||0.95|0.70|
91752442|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 9V: OPA GMT Ratio||0.94|0.71|
91752443|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.97|1.38||||||Serotype 14: OPA GMT Ratio||1.38|0.97|
91752444|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11||||||Serotype 18C: OPA GMT Ratio||1.11|0.90|
91752445|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.61|0.77||||||Serotype 19A: OPA GMT Ratio||0.77|0.61|
91752446|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.04||||||Serotype 19F: OPA GMT Ratio||1.04|0.84|
91507304|NCT00404352|182886425|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.002
91507305|NCT00404352|182886425|SUPERIORITY_OR_OTHER|||||||0.774|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.774
91507306|NCT01479621|182886432|SUPERIORITY_OR_OTHER|||||||0.0001||||||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed followed by pairwise comparisons of each Fp MDPI dose versus placebo.||||0.0001
91507307|NCT01479621|182886432|SUPERIORITY_OR_OTHER||LSM difference|0.149||||0.0005|TWO_SIDED|95.0|0.066|0.233||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|mixed model for repeated measures|||This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.233|0.066|0.0005
91507308|NCT01479621|182886432|SUPERIORITY_OR_OTHER||LSM difference|0.126||||0.0027|TWO_SIDED|95.0|0.044|0.208|||mixed model for repeated measures|||This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.208|0.044|0.0027
91507309|NCT01479621|182886432|SUPERIORITY_OR_OTHER||LSM difference|0.111||||0.0086|TWO_SIDED|95.0|0.028|0.194|||mixed model for repeated measures|||This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.194|0.028|0.0086
91507310|NCT01479621|182886432|SUPERIORITY_OR_OTHER||LSM difference|0.052||||0.2227|TWO_SIDED|95.0|-0.032|0.136|||mixed model for repeated measures|||This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.136|-0.032|0.2227
91507311|NCT01479621|182886433|SUPERIORITY_OR_OTHER|||||||0.0017||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0017
91507312|NCT01479621|182886433|SUPERIORITY_OR_OTHER||LSM difference|18.29||||0.006|TWO_SIDED|95.0|5.28|31.29||Significance at 0.05|mixed model for repeated measures|||||31.29|5.28|0.0060
91532528|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.086|0.203|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.203|0.086|<0.001
91507313|NCT01479621|182886433|SUPERIORITY_OR_OTHER||LSM difference|20.32||||0.0018|TWO_SIDED|95.0|7.61|33.03||Significance at 0.05|mixed model for repeated measures|||||33.03|7.61|0.0018
91507314|NCT01479621|182886433|SUPERIORITY_OR_OTHER||LSM difference|11.75||||0.0741|TWO_SIDED|95.0|-1.15|24.64||Significance at 0.05|mixed model for repeated measures|||||24.64|-1.15|0.0741
91507315|NCT01479621|182886433|SUPERIORITY_OR_OTHER||LSM difference|21.72||||0.0011|TWO_SIDED|95.0|8.73|34.72||Significance at 0.05|mixed model for repeated measures|||||34.72|8.73|0.0011
91507316|NCT01479621|182886434|SUPERIORITY_OR_OTHER|||||||0.0434||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0434
91507317|NCT01479621|182886434|SUPERIORITY_OR_OTHER||LSM difference|11.06||||0.0852|TWO_SIDED|95.0|-1.54|23.66||Significance at 0.05|mixed model for repeated measures|||||23.66|-1.54|0.0852
91507318|NCT01479621|182886434|SUPERIORITY_OR_OTHER||LSM difference|12.78||||0.0411|TWO_SIDED|95.0|0.52|25.04||Significance at 0.05|mixed model for repeated measures|||||25.04|0.52|0.0411
91507319|NCT01479621|182886434|SUPERIORITY_OR_OTHER||LSM difference|9.28||||0.1428|TWO_SIDED|95.0|-3.14|21.69||Significance at 0.05|mixed model for repeated measures|||||21.69|-3.14|0.1428
91507320|NCT01479621|182886434|SUPERIORITY_OR_OTHER||LSM difference|18.23||||0.0046|TWO_SIDED|95.0|5.64|30.82||Significance at 0.05|mixed model for repeated measures|||||30.82|5.64|0.0046
91507321|NCT01479621|182886435|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|2.76||||0.66685|TWO_SIDED|95.0|-10.07|15.6|||GEE|The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||15.60|-10.07|0.66685
91507322|NCT01479621|182886435|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|6.76||||0.26741|TWO_SIDED|95.0|-5.43|18.94||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||18.94|-5.43|0.26741
91507323|NCT01479621|182886435|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|10.45||||0.09964|TWO_SIDED|95.0|-2.24|23.15||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||23.15|-2.24|0.09964
91507324|NCT01479621|182886435|SUPERIORITY_OR_OTHER||Slope|12.78||||0.03825|TWO_SIDED|95.0|0.44|25.11||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||25.11|0.44|0.03825
91752447|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.74||||||Serotype 23F: OPA GMT Ratio||0.74|0.53|
91752448|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|560.46|||||TWO_SIDED|95.0|474.05|662.63||||||Serotype 22F: OPA GMT Ratio||662.63|474.05|
91752449|NCT04384107|183397617|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|196.14|||||TWO_SIDED|95.0|141.85|271.21||||||Serotype 33F: OPA GMT Ratio||271.21|141.85|
91507325|NCT01479621|182886436|SUPERIORITY_OR_OTHER|||||||0.2841||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.2841
91507326|NCT01479621|182886436|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||<0.0001
91507327|NCT01479621|182886436|SUPERIORITY_OR_OTHER|||||||0.0008||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0008
91507328|NCT01479621|182886436|SUPERIORITY_OR_OTHER|||||||0.001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0010
91507329|NCT01479621|182886442|SUPERIORITY_OR_OTHER||LSM difference|-0.114||||0.0058|TWO_SIDED|95.0|-0.195|-0.033||Significance at 0.05|mixed model for repeated measures|||||-0.033|-0.195|0.0058
91507330|NCT01479621|182886442|SUPERIORITY_OR_OTHER||LSM difference|0.034||||0.4083|TWO_SIDED|95.0|-0.046|0.114||Significance at 0.05|mixed model for repeated measures|||||0.114|-0.046|0.4083
91532529|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.255|||<|0.001|TWO_SIDED|95.0|0.193|0.318|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.318|0.193|<0.001
91507331|NCT01479621|182886442|SUPERIORITY_OR_OTHER||LSM difference|0.011||||0.7882|TWO_SIDED|95.0|-0.068|0.089||Significance at 0.05|mixed model for repeated measures|||||0.089|-0.068|0.7882
91507332|NCT01479621|182886442|SUPERIORITY_OR_OTHER||LSM difference|-0.002||||0.9586|TWO_SIDED|95.0|-0.082|0.078||Significance at 0.05|mixed model for repeated measures|||||0.078|-0.082|0.9586
91507333|NCT01479621|182886442|SUPERIORITY_OR_OTHER||LSM difference|-0.062||||0.1306|TWO_SIDED|95.0|-0.143|0.018||Significance at 0.05|mixed model for repeated measures|||||0.018|-0.143|0.1306
91507334|NCT01479621|182886443|SUPERIORITY_OR_OTHER||LSM difference|-17.66||||0.0068|TWO_SIDED|95.0|-30.43|-4.89||Significance at 0.05|mixed model for repeated measures|||||-4.89|-30.43|0.0068
91507335|NCT01479621|182886443|SUPERIORITY_OR_OTHER||LSM difference|0.69||||0.9135|TWO_SIDED|95.0|-11.84|13.23||Significance at 0.05|mixed model for repeated measures|||||13.23|-11.84|0.9135
91507336|NCT01479621|182886443|SUPERIORITY_OR_OTHER||LSM difference|2.67||||0.6689|TWO_SIDED|95.0|-9.58|14.92||Significance at 0.05|mixed model for repeated measures|||||14.92|-9.58|0.6689
91507337|NCT01479621|182886443|SUPERIORITY_OR_OTHER||LSM difference|-5.69||||0.3691|TWO_SIDED|95.0|-18.12|6.74||Significance at 0.05|mixed model for repeated measures|||||6.74|-18.12|0.3691
91507338|NCT01479621|182886443|SUPERIORITY_OR_OTHER||LSM difference|4.24||||0.5072|TWO_SIDED|95.0|-8.31|16.78||Significance at 0.05|mixed model for repeated measures|||||16.78|-8.31|0.5072
91507339|NCT01479621|182886444|SUPERIORITY_OR_OTHER||LSM difference|-15.26||||0.0158|TWO_SIDED|95.0|-27.63|-2.88||Significance at 0.05|mixed model for repeated measures|||||-2.88|-27.63|0.0158
91507340|NCT01479621|182886444|SUPERIORITY_OR_OTHER||LSM difference|-4.48||||0.4709|TWO_SIDED|95.0|-16.69|7.721||Significance at 0.05|mixed model for repeated measures|||||7.721|-16.69|0.4709
91752450|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.75||||||Serotype 1: OPA GMT Ratio||0.75|0.38|
91752451|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.03||||||Serotype 3: OPA GMT Ratio||2.03|1.28|
91507341|NCT01479621|182886444|SUPERIORITY_OR_OTHER||LSM difference|-2.68||||0.6572|TWO_SIDED|95.0|-14.55|9.19||Significance at 0.05|mixed model for repeated measures|||||9.19|-14.55|0.6572
91752452|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.93||||||Serotype 4: OPA GMT Ratio||0.93|0.57|
91752453|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.13||||||Serotype 5: OPA GMT Ratio||1.13|0.66|
91752454|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.91||||||Serotype 6A: OPA GMT Ratio||0.91|0.57|
91752455|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.52|0.83||||||Serotype 6B: OPA GMT Ratio||0.83|0.52|
91752456|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 7F: OPA GMT Ratio||1.07|0.68|
91752457|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.65|||||TWO_SIDED|95.0|0.5|0.84||||||Serotype 9V: OPA GMT Ratio||0.84|0.50|
91752458|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.16|1.9||||||Serotype 14: OPA GMT Ratio||1.90|1.16|
91752459|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.95|1.48||||||Serotype 18C: OPA GMT Ratio||1.48|0.95|
91752460|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Serotype 19A: OPA GMT Ratio||1.01|0.60|
91752461|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.23|||||TWO_SIDED|95.0|1.0|1.52||||||Serotype 19F: OPA GMT Ratio||1.52|1.00|
91752462|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.37|||||TWO_SIDED|95.0|0.28|0.49||||||Serotype 23F: OPA GMT Ratio||0.49|0.28|
91752463|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|155.88|||||TWO_SIDED|95.0|101.84|238.59||||||Serotype 22F: OPA GMT Ratio||238.59|101.84|
91752464|NCT04384107|183397618|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|16.81|||||TWO_SIDED|95.0|11.74|24.08||||||Serotype 33F: OPA GMT Ratio||24.08|11.74|
91752465|NCT01048866|183397634|SUPERIORITY_OR_OTHER||least-square means difference|-196.6||||0.0021|TWO_SIDED|95.0|-321.0|-72.2||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-72.2|-321.0|0.0021
91752466|NCT01048866|183397635|SUPERIORITY_OR_OTHER||least-square means difference|-19.0||||0.0002|TWO_SIDED|95.0|-28.7|-9.3||The a priori threshold for statistical significance is 0.05.|ANOVA|Baseline DSS fitted as a covariate and centre as a fixed effect.||||-9.3|-28.7|0.0002
91507342|NCT01479621|182886444|SUPERIORITY_OR_OTHER||LSM difference|-5.98||||0.3292|TWO_SIDED|95.0|-18.01|6.05||Significance at 0.05|mixed model for repeated measures|||||6.05|-18.01|0.3292
91507343|NCT01479621|182886444|SUPERIORITY_OR_OTHER||LSM difference|3.05||||0.6237|TWO_SIDED|95.0|-9.16|15.26||Significance at 0.05|mixed model for repeated measures|||||15.26|-9.16|0.6237
91507344|NCT03663283|182886445|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||||||.0197
91507345|NCT03663283|182886446|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||72 hours||||0.584
91752467|NCT01048866|183397636|SUPERIORITY_OR_OTHER||least-square means difference|-179.7||||0.0054|TWO_SIDED|95.0|-305.7|-53.8||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-53.8|-305.7|0.0054
91752468|NCT01048866|183397637|SUPERIORITY_OR_OTHER||least-square means difference|-16.4||||0.0008|TWO_SIDED|95.0|-25.9|-7.0||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-7.0|-25.9|0.0008
91752469|NCT01048866|183397638|SUPERIORITY_OR_OTHER||least-square means difference|-168.4||||0.0087|TWO_SIDED|95.0|-293.7|-43.1|||ANOVA|||||-43.1|-293.7|0.0087
91752470|NCT01048866|183397639|SUPERIORITY_OR_OTHER||least-square means difference|-19.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-10.0|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||-10.0|-28.0|<0.0001
91752471|NCT01048866|183397640|SUPERIORITY_OR_OTHER||least-square means difference|-118.9||||0.1844|TWO_SIDED|95.0|-295.3|57.5|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||57.5|-295.3|0.1844
91752472|NCT01048866|183397641|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91752473|NCT01048866|183397642|SUPERIORITY_OR_OTHER|||||||0.8827|||||||Wilcoxon (Mann-Whitney)|||||||0.8827
91752474|NCT01048866|183397643|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon (Mann-Whitney)|Stratified by centre||||||0.0105
91752475|NCT01048866|183397645|SUPERIORITY_OR_OTHER||least-square means difference|-5.9||||0.0743|TWO_SIDED|95.0|-12.4|0.6|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.6|-12.4|0.0743
91752476|NCT01048866|183397646|SUPERIORITY_OR_OTHER||least-square means difference|-5.5||||0.0871|TWO_SIDED|95.0|-11.7|0.8|||ANOVA|Repeated measures ANOVA model with patient as a random effect.||||0.8|-11.7|0.0871
91752477|NCT01048866|183397647|SUPERIORITY_OR_OTHER||least-square means difference|-6.0||||0.0595|TWO_SIDED|95.0|-12.3|0.2|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.2|-12.3|0.0595
91752478|NCT01048866|183397648|SUPERIORITY_OR_OTHER||least-square means difference|0.5||||0.0195|TWO_SIDED|95.0|0.1|0.9|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.9|0.1|0.0195
91752479|NCT01048866|183397649|SUPERIORITY_OR_OTHER|||||||0.0322|||||||Regression, Logistic|Effect for centre||||||0.0322
91752480|NCT01048866|183397650|SUPERIORITY_OR_OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
91752481|NCT01048866|183397651|SUPERIORITY_OR_OTHER||least-square means difference|-0.2||||0.0288|TWO_SIDED|95.0|-0.4|0.0|||ANOVA|||||-0.0|-0.4|0.0288
91507346|NCT03663283|182886446|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||3 weeks||||.5800
91507347|NCT03663283|182886447|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
91507348|NCT03663283|182886448|SUPERIORITY|||||||0.7018|||||||Wilcoxon (Mann-Whitney)|||72 hours||||.7018
91752482|NCT01048866|183397652|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.4274|TWO_SIDED|95.0|-0.3|0.1|||ANOVA|||||0.1|-0.3|0.4274
91752483|NCT03582813|183397653|SUPERIORITY||MIXREG Estimate|4.27|STANDARD_ERROR_OF_MEAN|1.61|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime;||||<.01
91752484|NCT03582813|183397654|SUPERIORITY||MIXREG Estimate|0.9|STANDARD_ERROR_OF_MEAN|0.42||0.031|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-esteem that would be maintained longitudinally||||.031
91752485|NCT03582813|183397655|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in coping mastery that would be maintained longitudinally||||<0.01
91752486|NCT03582813|183397656|SUPERIORITY||MIXREG Estimate|0.29|STANDARD_ERROR_OF_MEAN|0.13||0.03|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in perceived autonomy support that would be maintained longitudinally||||0.030
91752487|NCT03582813|183397657|SUPERIORITY||Odds Ratio (OR)|2.19||||0.046|TWO_SIDED|95.0|1.01|4.74|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of employment that would be maintained longitudinally||4.74|1.01|0.046
91752488|NCT03582813|183397658|SUPERIORITY||Odds Ratio (OR)|4.14|||<|0.01|TWO_SIDED|95.0|1.5|11.44|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of enrollment in educational classes that would be maintained longitudinally||11.44|1.50|<0.01
91752489|NCT00316524|183397660|NON_INFERIORITY|The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates|Difference in seroconversion rates (%)|-3.4|||||ONE_SIDED|97.5|-7.36||||||||||-7.36|
91752490|NCT02525094|183397671|SUPERIORITY||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.9|4.33||||||||4.33|0.90|
91507349|NCT03663283|182886448|SUPERIORITY|||||||0.5327|||||||Wilcoxon (Mann-Whitney)|||Week 3||||.5327
91507350|NCT00802412|182886460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.51|TWO_SIDED|95.0|0.4|6.5|||Regression, Logistic|||||6.5|0.4|0.51
91507351|NCT00802412|182886460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.45|TWO_SIDED|95.0|0.66|2.55|||Regression, Cox|||||2.55|0.66|.45
91507352|NCT01417481|182886461|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
91507353|NCT01417481|182886462|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
91507354|NCT01417481|182886463|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
91507355|NCT01417481|182886464|SUPERIORITY_OR_OTHER||||||=|0.061|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.061
91507356|NCT01417481|182886465|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.068
91507357|NCT01417481|182886466|SUPERIORITY_OR_OTHER||||||=|0.04|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.040
91507358|NCT01417481|182886467|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.05
91507359|NCT01417481|182886468|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, paired analysis was done. The hypothesis was that glycine will improve variables, thus significance was set at one-tail.||||||<0.05
91532530|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001||95.0|0.061|0.163|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.163|0.061|<0.001
91507360|NCT01417481|182886469|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.01
91752491|NCT02789410|183397690|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
91752492|NCT02789410|183397691|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.590
91752493|NCT02789410|183397692|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
91752494|NCT01751776|183397693|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0506|STANDARD_ERROR_OF_MEAN|0.4242|||TWO_SIDED|95.0|1.1843|2.9168|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the first adminstration of BI 65564 on Day 1.||2.9168|1.1843|
91752495|NCT01751776|183397693|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4227|STANDARD_ERROR_OF_MEAN|0.1644|||TWO_SIDED|95.0|1.0869|1.7584|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the last (fourth) adminstration of BI 65564 on Day 22.||1.7584|1.0869|
91507361|NCT01417481|182886470|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
91507362|NCT02614547|182886471|SUPERIORITY||Least Squares Mean Difference|-12.22|STANDARD_ERROR_OF_MEAN|4.081||0.008|TWO_SIDED|95.0|-20.77|-3.67|||MMRM|||Mixed Effects Model for Repeated Measure (MMRM) used an unstructured covariance model time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-3.67|-20.77|0.008
91532531|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.041|0.157|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.157|0.041|<0.001
91752496|NCT01751776|183397694|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0091|STANDARD_ERROR_OF_MEAN|0.1706|||TWO_SIDED|95.0|1.6607|2.3575|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUC 0-infinity was explored after the last adminstration of BI 65564 on Day 22.||2.3575|1.6607|
91752497|NCT01751776|183397695|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4225|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.0876|1.7574|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUCtau was explored after the last administration of BI 65564 on Day 22.||1.7574|1.0876|
91752498|NCT01751776|183397697|OTHER||Mean Difference (Net)|22.7|||||||||||||Mean Difference in percentage|Observed difference of ACR20 response for BI 120mg - Placebo||||
91752499|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Mean Difference (Net)|33.0|||||||||||||Mean Difference in percentage|Expected difference of ACR20 response for BI 120mg - Placebo||||
91752500|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 0%||||
91752501|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 5%||||
91752502|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|98.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 10%||||
91752503|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|96.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 15%||||
91752504|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|90.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 20%||||
91752505|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|79.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 25%||||
91507363|NCT02614547|182886472|SUPERIORITY||Odds Ratio (OR)|4.08||||0.198|TWO_SIDED|95.0|0.49|37.67|||Fisher Exact|||60 Hours||37.67|0.49|0.198
91507364|NCT02614547|182886472|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
91507365|NCT02614547|182886472|SUPERIORITY||Odds Ratio (OR)|6.22||||0.086|TWO_SIDED|95.0|0.7|62.08|||Fisher Exact|||Day 30||62.08|0.70|0.086
91507366|NCT02614547|182886473|SUPERIORITY||Odds Ratio (OR)|23.33||||0.008|TWO_SIDED|95.0|1.56|1152.71|||Fisher Exact|||60 Hours||1152.71|1.56|0.008
91507367|NCT02614547|182886473|SUPERIORITY|||||||0.003|||||||Fisher Exact|||Day 7||||0.003
91507368|NCT02614547|182886473|SUPERIORITY||Odds Ratio (OR)|10.5||||0.03|TWO_SIDED|95.0|1.01|140.57|||Fisher Exact|||Day 30||140.57|1.01|0.030
91507369|NCT02614547|182886474|SUPERIORITY||Least Squares Mean Difference|-15.86|STANDARD_ERROR_OF_MEAN|5.536||0.01|TWO_SIDED|95.0|-27.5|-4.22|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.22|-27.50|0.010
91507370|NCT02614547|182886474|SUPERIORITY||Least Square Mean Difference|-15.96|STANDARD_ERROR_OF_MEAN|5.448||0.009|TWO_SIDED|95.0|-27.43|-4.5|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.50|-27.43|0.009
91507371|NCT02614547|182886474|SUPERIORITY||Least Square Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.213||0.01|TWO_SIDED|95.0|-26.05|-4.09|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.09|-26.05|0.010
91752506|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|62.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 30%||||
91752507|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|42.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 35%||||
91752508|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|24.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 40%||||
91752509|NCT01751776|183397697|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|11.1||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 45%||||
91752510|NCT01751776|183397698|SUPERIORITY_OR_OTHER_LEGACY||Risk difference, unadjusted|18.2||||0.0754|TWO_SIDED|95.0|-6.6|38.6|||One-sided exact test (see description)|One-sided exact test for superiority testing|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||38.6|-6.6|0.0754
91752511|NCT01751776|183397698|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|20.0|||||TWO_SIDED|95.0|-4.6|39.0|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-Tumour Necrosis Factor (TNF)|adjusted||39.0|-4.6|
91752512|NCT01751776|183397699|SUPERIORITY_OR_OTHER_LEGACY||risk difference, unadjusted|4.5||||0.3938|TWO_SIDED|95.0|-18.4|22.3|||one-sided exact test (see description)|one-sided exact test for superiority testing.|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||22.3|-18.4|0.3938
91752513|NCT01751776|183397699|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|4.0|||||TWO_SIDED|95.0|-18.9|21.1|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||21.1|-18.9|
91752514|NCT01751776|183397702|SUPERIORITY_OR_OTHER_LEGACY||Risk difference|6.8|||||TWO_SIDED|95.0|-17.6|32.7|||||The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||32.7|-17.6|
91752515|NCT01751776|183397702|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|8.9|||||TWO_SIDED|95.0|-15.9|34.2|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||34.2|-15.9|
91507372|NCT02614547|182886475|SUPERIORITY||Odds Ratio (OR)|7.0||||0.08|TWO_SIDED|95.0|0.73|90.81|||Fisher Exact|||60 Hours||90.81|0.73|0.080
91507373|NCT02614547|182886475|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
91507374|NCT02614547|182886475|SUPERIORITY||Odds Ratio (OR)|10.67||||0.03|TWO_SIDED|95.0|1.04|142.2|||Fisher Exact|||Day 30||142.20|1.04|0.030
91507375|NCT02614547|182886476|SUPERIORITY||Least Squares Mean Difference|-6.05|STANDARD_ERROR_OF_MEAN|2.466||0.025|TWO_SIDED|95.0|-11.24|-0.86|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-0.86|-11.24|0.025
91507376|NCT02614547|182886476|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|2.427||0.016|TWO_SIDED|95.0|-11.57|-1.34|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.34|-11.57|0.016
91507377|NCT02614547|182886476|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.568||0.018|TWO_SIDED|95.0|-12.25|-1.35|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.35|-12.25|0.018
91507378|NCT02614547|182886478|SUPERIORITY||Least Squares Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|2.461||0.457|TWO_SIDED|95.0|-3.3|7.04|||ANCOVA|||60 Hours||7.04|-3.30|0.457
91507379|NCT02614547|182886478|SUPERIORITY||Least Square Mean|-1.47|STANDARD_ERROR_OF_MEAN|-1.47||0.613|TWO_SIDED|95.0|-7.5|4.55|||ANCOVA|||Day 7||4.55|-7.50|0.613
91507380|NCT02614547|182886478|SUPERIORITY||Least Square Mean|-2.1|STANDARD_ERROR_OF_MEAN|2.871||0.474|TWO_SIDED|95.0|-8.13|3.93|||ANCOVA|||Day 30||3.93|-8.13|0.474
91507381|NCT00409292|182886504|SUPERIORITY_OR_OTHER|||||||0.1|||||||binomial hypothesis test|||||||0.10
91532532|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.132|||<|0.001|TWO_SIDED|95.0|0.081|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.183|0.081|<0.001
91507382|NCT00405548|182886558|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91507383|NCT00405548|182886559|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91532533|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.006||||0.849|TWO_SIDED|95.0|-0.055|0.067|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.067|-0.055|0.849
91507384|NCT00405548|182886560|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91507385|NCT00405548|182886561|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the BNP group.||||0.004
91507386|NCT00405548|182886561|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the Placebo group.||||0.43
91507387|NCT04652479|182886579|OTHER|||||||0.0028||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0028
91507388|NCT04652479|182886579|OTHER|||||||0.0005||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0005
91507389|NCT04652479|182886580|OTHER|||||||0.0027||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0027
91507390|NCT04652479|182886580|OTHER|||||||0.0043||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0043
91507391|NCT04652479|182886581|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
91507392|NCT04652479|182886581|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
91507393|NCT04652479|182886582|OTHER|||||||0.161||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.161
91507394|NCT04652479|182886582|OTHER||Mean Difference (Net)|-35.66||||0.201|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.201
91507395|NCT04652479|182886582|OTHER||Mean Difference (Net)|-67.65||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.001
91507396|NCT04652479|182886583|OTHER|||||||0.145||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.145
91507397|NCT04652479|182886583|OTHER||Mean Difference (Net)|-31.88||||0.111|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.111
91507398|NCT04652479|182886583|OTHER||Mean Difference (Net)|-53.37||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.001
91507399|NCT00811577|182886587|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.57
91507400|NCT00811577|182886587|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.56
91507401|NCT00811577|182886587|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.61
91507402|NCT00811577|182886587|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.80
91507403|NCT00811577|182886588|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.47
91507404|NCT00811577|182886588|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.080
91507405|NCT00811577|182886588|SUPERIORITY_OR_OTHER|||||||0.96||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.96
91507406|NCT00811577|182886588|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.22
91532534|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.15|||<|0.001|TWO_SIDED|95.0|0.098|0.201|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.201|0.098|<0.001
91507407|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.87
91532535|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.243|||<|0.001|TWO_SIDED|95.0|0.202|0.284|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.284|0.202|<0.001
91532536|NCT01323660|182941763|SUPERIORITY_OR_OTHER||Least squares mean difference|0.261|||<|0.001|TWO_SIDED|95.0|0.22|0.303|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.303|0.220|<0.001
91752516|NCT01751776|183397703|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean|-0.14|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|95.0|-0.67|0.39|||||difference calculated as BI 655064 120mg minus placebo. The ANCOVA model was used. In this model the mean was adjusted for region, anti-TNF history and baseline DAS28-CRP.|difference calculated as BI 655064 120mg minus placebo.||0.39|-0.67|
91752517|NCT01307462|183397741|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based physical functioning score||||.81
91752518|NCT01307462|183397741|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-physical score||||.18
91752519|NCT01307462|183397741|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based bodily pain score||||.48
91752520|NCT01307462|183397741|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based general health score||||.26
91752521|NCT01307462|183397741|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based vitality score||||.23
91752522|NCT01307462|183397741|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based social functioning score||||.36
91752523|NCT01307462|183397741|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-emotional score||||.41
91752524|NCT01307462|183397741|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based mental health score||||.80
91752525|NCT01307462|183397741|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized physical component score||||.80
91752526|NCT01307462|183397741|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized mental component score||||.23
91752527|NCT01307462|183397742|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||FACT physical well-being||||0.28
91752528|NCT01307462|183397742|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||FACT social/family well-being||||0.1
91507408|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.15
91752529|NCT01307462|183397742|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||FACT emotional well-being||||0.63
91752530|NCT01307462|183397742|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||FACT functional well-being||||0.78
91752531|NCT01307462|183397742|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||FACT BMT subscale||||.84
91752532|NCT01307462|183397742|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||FACT trial outcome index||||.37
91752533|NCT01307462|183397742|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||FACT-G||||.71
91752534|NCT01307462|183397742|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||FACT-BMT total||||.54
91752535|NCT01307462|183397743|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||HAP maximum activity score - highest item still doing||||.37
91752536|NCT01307462|183397743|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||HAP adjusted activity score - MAS minus stopped||||.39
91752537|NCT01307462|183397743|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Modified HAP adjusted activity score||||.39
91752538|NCT01307462|183397744|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Lee symptom skin scale||||.11
91752539|NCT01307462|183397744|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Lee symptom energy scale||||.007
91752540|NCT01307462|183397744|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Lee symptom lung scale||||.20
91752541|NCT01307462|183397744|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom eye scale||||.002
91752542|NCT01307462|183397744|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Lee symptom nutrition scale||||.52
91752543|NCT01307462|183397744|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Lee symptom psychological scale||||.22
91752544|NCT01307462|183397744|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom mouth scale||||.002
91752545|NCT01307462|183397744|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Lee symptom overall summary scale||||<0.001
91752546|NCT01519674|183397789|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.24||||0.011||95.0|0.06|0.43||No corrections for multiplicity were performed.|Regression, Linear|||"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:~H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met)."||0.43|0.06|0.011
91752547|NCT01519674|183397789|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.11||||0.231||95.0|-0.3|0.07|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||0.07|-0.30|0.231
91752548|NCT01519674|183397789|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.36|||<|0.001||95.0|-0.54|-0.17|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||-0.17|-0.54|<0.001
91752549|NCT01519674|183397790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.022||95.0|0.39|0.93|||Regression, Logistic|||||0.93|0.39|0.022
91752550|NCT01519674|183397790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.618||95.0|0.73|1.71|||Regression, Logistic|||||1.71|0.73|0.618
91507409|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.77
91507410|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.75
91532537|NCT01207934|182941802|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||ANOVA for reapeated measures was used to compare the three groups.|ANOVA|||The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.||||>0.05
91507411|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.050
91507412|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.83
91507413|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.37
91507414|NCT00811577|182886589|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.43
91507415|NCT00811577|182886590|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.16
91507416|NCT00811577|182886590|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.14
91507417|NCT00811577|182886590|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.69
91752551|NCT01519674|183397790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.005||95.0|1.2|2.85|||Regression, Logistic|||||2.85|1.20|0.005
91752552|NCT01519674|183397791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.02||95.0|0.38|0.92|||Regression, Logistic|||||0.92|0.38|0.020
91752553|NCT01519674|183397791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.286||95.0|0.81|2.07|||Regression, Logistic|||||2.07|0.81|0.286
91752554|NCT01519674|183397791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||<|0.001||95.0|1.39|3.47|||Regression, Logistic|||||3.47|1.39|<0.001
91752555|NCT01519674|183397792|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.13||||0.52||95.0|-0.26|0.52|||Regression, Linear|||||0.52|-0.26|0.520
91752556|NCT01519674|183397792|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.05||||0.788||95.0|-0.34|0.45|||Regression, Linear|||||0.45|-0.34|0.788
91752557|NCT01519674|183397792|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.07||||0.708||95.0|-0.46|0.31|||Regression, Linear|||||0.31|-0.46|0.708
91752558|NCT01519674|183397793|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.28||||0.291||95.0|-0.24|0.81|||Regression, Linear|||||0.81|-0.24|0.291
91752559|NCT01519674|183397793|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.88||||0.001||95.0|-1.41|-0.35|||Regression, Linear|||||-0.35|-1.41|0.001
91752560|NCT01519674|183397793|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.16|||<|0.001||95.0|-1.69|-0.64|||Regression, Linear|||||-0.64|-1.69|<0.001
91752561|NCT01519674|183397794|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.85||||0.005||95.0|0.26|1.45|||Regression, Linear|||||1.45|0.26|0.005
91752562|NCT01519674|183397794|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.52||||0.085||95.0|-0.07|1.12|||Regression, Linear|||||1.12|-0.07|0.085
91752563|NCT01519674|183397794|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.33||||0.275||95.0|-0.92|0.26|||Regression, Linear|||||0.26|-0.92|0.275
91752564|NCT01519674|183397795|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.674||95.0|-0.7|0.45|||Regression, Linear|||||0.45|-0.70|0.674
91752565|NCT01519674|183397795|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.72||||0.015||95.0|0.14|1.3|||Regression, Linear|||||1.30|0.14|0.015
91752566|NCT01519674|183397795|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.84||||0.004||95.0|0.27|1.41|||Regression, Linear|||||1.41|0.27|0.004
91752567|NCT01519674|183397796|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.31||||0.08||95.0|-0.04|0.65|||Regression, Linear|||||0.65|-0.04|0.080
91752568|NCT01519674|183397796|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.09||||0.613||95.0|-0.26|0.43|||Regression, Linear|||||0.43|-0.26|0.613
91752569|NCT01519674|183397796|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.22||||0.213||95.0|-0.56|0.13|||Regression, Linear|||||0.13|-0.56|0.213
91752570|NCT01519674|183397799|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.29||||0.8||95.0|-1.97|2.56|||Regression, Linear|||||2.56|-1.97|0.800
91752571|NCT01519674|183397799|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.02||||0.989||95.0|-2.26|2.29|||Regression, Linear|||||2.29|-2.26|0.989
91752572|NCT01519674|183397799|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.28||||0.809||95.0|-2.52|1.97|||Regression, Linear|||||1.97|-2.52|0.809
91752573|NCT00733135|183397817|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||GEE|||||||<0.05
91752574|NCT01854632|183397826|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Log Rank|||||||0.996
91752575|NCT03180398|183397837|SUPERIORITY|It was hoped to compare radiomics features, using non-parametric tests, but this was not possible because of the small number of patients accrued.|||||||||||||||||Not enough patients were accrued for radiomics analysis. PI left institution and country. Analysis could not be completed.|||
91752576|NCT03180398|183397838|OTHER|Analysis could not be completed.|||||||||||||||||PI left institution and country. Analysis could not be completed.|||
91507418|NCT00811577|182886590|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.89
91507419|NCT00811577|182886590|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.30
91507420|NCT00811577|182886590|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.46
91532538|NCT01207934|182941803|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|T-tests compared pre and post-treatment values.||The null hypothesis is that treatment would not effect plasma leptin levels.||||<0.01
91752577|NCT00610441|183397879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6996||||0.0147|TWO_SIDED|97.5|-10.911|-0.4881||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|Mixed Model for Repeated Measurements||Mixed Model for Repeated Measurements (MMRM) with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||-0.4881|-10.911|0.0147
91752578|NCT00610441|183397879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9926||||0.591|TWO_SIDED|97.5|-3.2961|5.2814||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.2814|-3.2961|0.5910
91752579|NCT00610441|183397880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.8506|||||TWO_SIDED|95.0|1.799|26.0878|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||26.0878|1.7990|
91752580|NCT00610441|183397880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9461|||||TWO_SIDED|95.0|0.3119|2.8701|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||2.8701|0.3119|
91752581|NCT00610441|183397881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2468|||||TWO_SIDED|95.0|0.6712|58.1395|||||Since no participants in the Placebo group achieved a 50% reduction, the comparison was done using a Cochran-Mantel-Haenszel method and 0.5 was added to both groups.|||58.1395|0.6712|
91752582|NCT00610441|183397881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1453|||||TWO_SIDED|95.0|0.0152|1.388|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||1.3880|0.0152|
91752583|NCT00610441|183397884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2074|||||TWO_SIDED|95.0|0.5654|2.5785|||||Proportional odds model with fixed effects for treatment and period.|||2.5785|0.5654|
91752584|NCT00610441|183397884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8548|||||TWO_SIDED|95.0|0.6951|4.9494|||||Proportional odds model with fixed effects for treatment and period.|||4.9494|0.6951|
91752585|NCT00610441|183397885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3149|||||TWO_SIDED|95.0|0.5402|3.2008|||||Proportional odds model with fixed effects for treatment and period.|||3.2008|0.5402|
91752586|NCT00610441|183397885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3982|||||TWO_SIDED|95.0|0.524|3.7309|||||Proportional odds model with fixed effects for treatment and period.|||3.7309|0.5240|
91752587|NCT00610441|183397886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3163||||0.6155|TWO_SIDED|97.5|-1.8138|1.1812||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1812|-1.8138|0.6155
91752588|NCT00610441|183397886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2934||||0.133|TWO_SIDED|97.5|-0.7449|3.3317||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||3.3317|-0.7449|0.1330
91507421|NCT00811577|182886591|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.086
91507422|NCT00811577|182886591|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.66
91752589|NCT00610441|183397887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5501||||0.3907|TWO_SIDED|97.5|-0.9427|2.0429||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||2.0429|-0.9427|0.3907
91507423|NCT00811577|182886591|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.069
91507424|NCT00811577|182886591|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.68
91507425|NCT00811577|182886591|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.095
91507426|NCT00811577|182886591|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.62
91507427|NCT00811577|182886592|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.44
91507428|NCT00811577|182886592|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.41
91507429|NCT01455012|182886601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-160.34|STANDARD_ERROR_OF_MEAN|26.46|<|0.0001|TWO_SIDED|95.0|-213.23|-107.45||The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.|ANCOVA||The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.|The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).||-107.45|-213.23|<0.0001
91507430|NCT00615056|182886692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.273||||0.8268|TWO_SIDED|95.0|0.769|2.108||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.108|0.769|0.8268
91507431|NCT00615056|182886692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.041||||0.5498|TWO_SIDED|95.0|0.553|1.041||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.041|0.553|0.5498
91507432|NCT00615056|182886693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.355||||0.8828|TWO_SIDED|95.0|0.82|2.238||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.238|0.820|0.8828
91507433|NCT00615056|182886693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689||||0.1159|TWO_SIDED|95.0|0.373|1.273||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.273|0.373|0.1159
91507434|NCT00615056|182886694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4552|TWO_SIDED|95.0|-15.8|17.7|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||17.7|-15.8|0.4552
91507435|NCT00615056|182886694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5235|TWO_SIDED|95.0|-19.1|18.0|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||18.0|-19.1|0.5235
91507436|NCT00717769|182886699|SUPERIORITY|||||||0.519|||||||ANCOVA|||Change from Baseline to Day 8||||0.519
91507437|NCT00717769|182886699|SUPERIORITY|||||||0.032|||||||ANCOVA|||Change from Baseline to Day 15||||0.032
91507438|NCT00717769|182886699|SUPERIORITY|||||||0.008|||||||ANCOVA|||Change from Baseline to Day 22||||0.008
91507439|NCT00717769|182886699|SUPERIORITY|||||||0.006|||||||ANCOVA|||Change from Baseline to Day 29||||0.006
91507440|NCT00717769|182886701|SUPERIORITY|||||||0.533|||||||ANCOVA|||Change from Baseline to Day 8||||0.533
91507441|NCT00717769|182886701|SUPERIORITY|||||||0.009|||||||ANCOVA|||Change from Baseline to Day 15||||0.009
91507442|NCT00717769|182886701|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change from Baseline to Day 22||||0.002
91507443|NCT00717769|182886701|SUPERIORITY|||||||0.003|||||||ANCOVA|||Change from Baseline to Day 29||||0.003
91507444|NCT01101841|182886824|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
91507445|NCT01101841|182886824|SUPERIORITY_OR_OTHER|||||||0.0001||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0001
91507446|NCT01101841|182886825|SUPERIORITY_OR_OTHER|||||||0.0066||||||Week 24 persistence of effect|Logit model|||||||0.0066
91507447|NCT01101841|182886840|SUPERIORITY_OR_OTHER|||||||0.0368||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0368
91752590|NCT00610441|183397887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0065||||0.9872|TWO_SIDED|97.5|-0.9486|0.9357||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||0.9357|-0.9486|0.9872
91752591|NCT00610441|183397888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1543||||0.7828|TWO_SIDED|97.5|-1.4898|1.1811||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1811|-1.4898|0.7828
91752592|NCT00610441|183397888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4222||||0.2883|TWO_SIDED|97.5|-0.5187|1.363||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.3630|-0.5187|0.2883
91752593|NCT00610441|183397889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9685||||0.6532|TWO_SIDED|97.5|-5.9599|4.0229|||MMRM|To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||4.0229|-5.9599|0.6532
91752594|NCT00610441|183397889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1022||||0.5247|TWO_SIDED|97.5|-2.8951|5.0996||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.0996|-2.8951|0.5247
91752595|NCT00334282|183397901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||1e-07||95.0|0.34|0.62||stratified log-rank test|Log Rank||The estimated value is the hazard ratio comparing pazopanib to placebo.|||0.62|0.34|.0000001
91752596|NCT00130923|183397945|SUPERIORITY||difference in treatment slopes|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.054|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment slopes in a mixed model and its standard error.|||||0.054
91752597|NCT00130923|183397946|SUPERIORITY||Difference in treatment means|-0.62|STANDARD_ERROR_OF_MEAN|0.29||0.035|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.035
91752598|NCT00130923|183397947|SUPERIORITY||difference in treatment means|0.056|STANDARD_ERROR_OF_MEAN|0.099||0.57|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.57
91752599|NCT00130923|183397948|SUPERIORITY||difference in treatment means|2.65|STANDARD_ERROR_OF_MEAN|2.68||0.32|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient difference in treatment means in a mixed model and its standard error.|||||.32
91752600|NCT00130923|183397949|SUPERIORITY||difference in treatment means|0.93|STANDARD_ERROR_OF_MEAN|1.19||0.44|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.44
91752601|NCT00130923|183397950|SUPERIORITY|||||||0.003|||||||Chi-squared|Statistical test of hypothesis. Value of the Chi-squared statistic is 9.08||||||.003
91752602|NCT01370837|183397967|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.84
91752603|NCT01370837|183397967|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.76
91507448|NCT01101841|182886840|SUPERIORITY_OR_OTHER|||||||0.0064||||||Week 12 severity|Rank transformed ANCOVA|||||||0.0064
91507449|NCT00653224|182886841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.33|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.33|<0.001
91507450|NCT00653224|182886842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
91752604|NCT01370837|183397967|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.53
91507451|NCT00653224|182886843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001||95.0|-0.47|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.47|<0.001
91507452|NCT00653224|182886844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
91532539|NCT01207934|182941803|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was p = 0.05.|t-test, 2 sided|||null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.||||<0.01
91532540|NCT01276535|182941809|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
91513414|NCT02328326|182898543|SUPERIORITY||Median Difference (Net)|0.15||||0.21|TWO_SIDED|95.0|-0.09|0.4|||Regression, Linear|Model adjusted for BL value of Cho to HDL Ratio, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.||0.40|-0.09|0.21
91752605|NCT01370837|183397967|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.07
91752606|NCT01370837|183397967|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.25
91513415|NCT02328326|182898545|SUPERIORITY||Mean Difference (Net)|0.3||||0.01|TWO_SIDED|95.0|0.08|0.53|||Regression, Linear|Model was adjusted for baseline value of IOCQ, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.||0.53|0.08|0.01
91752607|NCT01370837|183397967|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.27
91752608|NCT01370837|183397967|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||< 0.01
91752609|NCT00740714|183397971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.85|>|0.025|TWO_SIDED|97.5|-1.33|2.51||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.||2.51|-1.33|>0.025
91752610|NCT00740714|183397971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|0.86|>|0.025|TWO_SIDED|95.0|-0.85|3.03||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.||3.03|-0.85|>0.025
91752611|NCT00740714|183397972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.84||0.7943|TWO_SIDED|97.5|-2.12|1.68||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.68|-2.12|0.7943
91752612|NCT00740714|183397972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.85||0.306||95.0|-2.79|1.04||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.04|-2.79|0.306
91507453|NCT00653224|182886845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.042||95.0|-0.49|-0.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.01|-0.49|0.042
91513416|NCT02328326|182898546|EQUIVALENCE|Equivalent distribution among categories|difference in count|-1.0||||0.17|TWO_SIDED||||||Chi-squared||||Difference in count of those who stopped smoking in CO-IMPACT vs. those who stopped smoking in PACT.|||0.17
91752613|NCT00740714|183397973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|<|0.1615|TWO_SIDED|97.5|-0.25|0.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.06|-0.25|<0.1615
91752614|NCT00740714|183397973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7627|TWO_SIDED|95.0|-0.17|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.17|0.7627
91752615|NCT00740714|183397974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6383|STANDARD_ERROR_OF_MEAN|1.18||0.6383|TWO_SIDED|97.5|-2.1|3.21||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.21|-2.10|0.6383
91752616|NCT00740714|183397974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|1.19||0.667|TWO_SIDED|95.0|-3.2|2.17||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||2.17|-3.20|0.667
91752617|NCT00740714|183397975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|1.14||0.671|TWO_SIDED|97.5|-2.09|3.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.06|-2.09|0.671
91752618|NCT00740714|183397975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.16||0.671|TWO_SIDED|95.0|-3.34|1.87||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable||1.87|-3.34|0.671
91752619|NCT00740714|183397976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3445|TWO_SIDED|97.5|-0.04|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Hoehn \& Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.04|0.3445
91513417|NCT02328326|182898547|SUPERIORITY||Mean Difference (Net)|-0.04||||0.87|TWO_SIDED|95.0|-0.56|0.47|||Regression, Linear|Model adjusted for BL value of Physical Activity, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.||0.47|-0.56|0.87
91513418|NCT02328326|182898548|SUPERIORITY||Mean Difference (Net)|0.23||||0.31|TWO_SIDED|95.0|-0.22|0.68|||Regression, Linear|Model adjusted for BL value of Blood Sugar Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.||0.68|-0.22|0.31
91507454|NCT00653224|182886846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.014||95.0|-0.52|-0.06||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.52|0.014
91507455|NCT00653224|182886847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.036||95.0|-0.51|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-0.51|0.036
91507456|NCT00653224|182886848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.01||95.0|-0.48|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.48|0.010
91507457|NCT00653224|182886849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.026||95.0|-0.43|-0.03||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.43|0.026
91532541|NCT01276535|182941810|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
91532542|NCT00180674|182941811|SUPERIORITY|||||||0.043|||||||Wilcoxon Signed Ranks test|||||||0.043
91532543|NCT01106976|182941817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0012||||0.0009|TWO_SIDED||||||t-test, 1 sided|||Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.||||0.0009
91752620|NCT00740714|183397976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.05||0.239||95.0|-0.04|0.14||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.||Change from Baseline visit to 16-month visit on Hoehn \& Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.14|-0.04|.239
91507458|NCT00653224|182886850|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25||||0.018||95.0|-0.45|-0.04||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.45|0.018
91507459|NCT00653224|182886851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.002||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.002
91507460|NCT00653224|182886852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.006||95.0|-0.41|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.41|0.006
91532544|NCT05677867|182941836|OTHER||Ratio of Adjusted Geometric Means|97.4|||||TWO_SIDED|90.0|92.92|102.08|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% Confidence Intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.08|92.92|
91752621|NCT00740714|183397977|SUPERIORITY_OR_OTHER||Slope|0.536|STANDARD_ERROR_OF_MEAN|0.282||0.0577|TWO_SIDED|95.0|-0.018|1.091|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.||1.091|-0.018|0.0577
91752622|NCT00740714|183397977|SUPERIORITY_OR_OTHER||Slope|0.245|STANDARD_ERROR_OF_MEAN|0.451||0.5889|TWO_SIDED|95.0|-0.647|1.136|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.||1.136|-0.647|0.5889
91752623|NCT00740714|183397977|SUPERIORITY_OR_OTHER||Slope|0.631|STANDARD_ERROR_OF_MEAN|0.608||0.3006|TWO_SIDED|95.0|-0.569|1.831|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.||1.831|-0.569|0.3006
91752624|NCT00740714|183397977|SUPERIORITY_OR_OTHER||Slope|2.126|STANDARD_ERROR_OF_MEAN|1.269||0.096|TWO_SIDED|95.0|-0.382|4.633|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.||4.633|-0.382|0.096
91752625|NCT00740714|183397978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.57|2.8|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||2.80|0.57|<0.05
91752626|NCT00740714|183397979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.62|3.57|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience||3.57|0.62|<0.05
91752627|NCT00740714|183397980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.65|4.2|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||4.20|0.65|<0.05
91752628|NCT00740714|183397981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.46|1.79|||ANCOVA||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.79|0.46|<0.05
91752629|NCT00740714|183397982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.66|3.41|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.41|0.66|<0.05
91752630|NCT00740714|183397983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.81|9.72|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9.72|0.81|<0.05
91752631|NCT00740714|183397984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.52|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.52|0.31|<0.05
91752632|NCT00740714|183397985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.70|0.36|<0.05
91752633|NCT00740714|183397986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.69|8.58|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.58|0.69|<0.05
91752634|NCT00740714|183397987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.62|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.62|0.31|<0.05
91752635|NCT00740714|183397988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.77|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.77|<0.05
91752636|NCT00740714|183397989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.25|1.12|||Fisher Exact||Odds ration \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.12|0.25|<0.05
91752637|NCT00740714|183397990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|0.64|8.01|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.01|0.64|<0.05
91752638|NCT00740714|183397991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.55|3.24|||Fisher Exact||Odds ratio of \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.24|0.55|<0.05
91752639|NCT00740714|183397992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.48|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|0.48|<0.05
91752640|NCT00740714|183397993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.51|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.51|<0.05
91752641|NCT01049802|183398024|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91752642|NCT01049802|183398025|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91752643|NCT01049802|183398026|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91752644|NCT01049802|183398027|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91752645|NCT01049802|183398028|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91752646|NCT03461406|183398126|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Parenchymous)||1.09|0.92|< 0.001
91752647|NCT03461406|183398126|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8|Relative risk|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.16|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Soft Tissue)||1.16|0.91|< 0.001
91752648|NCT03461406|183398127|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Parenchymous)||1.09|0.92|< 0.001
91752649|NCT03461406|183398127|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Soft tissue)||1.09|0.92|< 0.001
91752650|NCT03461406|183398128|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|0.98|||<|0.001|TWO_SIDED|95.0|0.94|1.02|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Parenchymous)||1.02|0.94|< 0.001
91752651|NCT03461406|183398128|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Soft tissue)||1.09|0.92|< 0.001
91752652|NCT01969500|183398147|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|3.81||0.85|TWO_SIDED|95.0|-8.37|6.96|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||6.96|-8.37|.85
91752653|NCT01969500|183398148|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.67||0.44|TWO_SIDED|95.0|-4.66|2.06|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||2.06|-4.66|.44
91752654|NCT02193087|183398151|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.29|||||TWO_SIDED|90.0|0.23|0.36||||||DEN-1||0.36|0.23|
91752655|NCT02193087|183398151|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.9|1.26||||||DEN-2||1.26|0.90|
91752656|NCT02193087|183398151|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.46|||||TWO_SIDED|90.0|1.13|1.89||||||DEN-3||1.89|1.13|
91752657|NCT02193087|183398151|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.74|||||TWO_SIDED|90.0|0.57|0.95||||||DEN-4||0.95|0.57|
91752658|NCT02741570|183398177|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0469|TWO_SIDED|97.51|0.59|1.03|||Log Rank|stratified regular log-rank test||||1.03|0.59|0.0469
91752659|NCT02741570|183398178|SUPERIORITY||Cox Proportional Hazard|0.95||||0.4951|TWO_SIDED|97.9|0.8|1.13|||Log Rank|stratified regular log-rank test||||1.13|0.80|0.4951
91752660|NCT02741570|183398179|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||||0.95|0.68|
91752661|NCT02741570|183398180|SUPERIORITY||Cox Proportional Hazard|1.4|||||TWO_SIDED|95.0|1.19|1.63|||||All Randomized Participants|||1.63|1.19|
91752662|NCT02741570|183398180|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.77|1.3|||||All Randomized PD-L1 CPS \>= 20 Participants|||1.30|0.77|
91752663|NCT02741570|183398183|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
91752664|NCT02741570|183398184|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.82|1.08||||||||1.08|0.82|
91752665|NCT00946322|183398191|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.028
91752666|NCT00946322|183398192|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.||||.022
91752667|NCT00946322|183398193|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.043
91752668|NCT00946322|183398194|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.482
91752669|NCT00946322|183398195|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.009
91752670|NCT00946322|183398196|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.001
91752671|NCT00946322|183398197|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.027
91752672|NCT00946322|183398198|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.177
91752673|NCT01075971|183398199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|||<|0.0001|TWO_SIDED|95.0|1.35|2.19||Analysis of variance with repeated measurements (daily scores from day 1 to day 5) for the whole set of patients was performed adjusted on the formulation (SL vs. FDT). Other independent factors were the subject and the day.|Analysis of variance|||||2.19|1.35|<0.0001
91752674|NCT01241760|183398200|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.|Difference in proportion of response, %|1.5||||||95.0|-4.9|12.0|||Regression, Logistic|The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.|Observed data|||12|-4.9|
91752675|NCT01636713|183398209|SUPERIORITY_OR_OTHER||Least squares mean difference|0.151|||<|0.001|TWO_SIDED|95.0|0.11|0.191|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.191|0.110|<0.001
91752676|NCT01636713|183398209|SUPERIORITY_OR_OTHER||Least squares mean difference|0.216|||<|0.001|TWO_SIDED|95.0|0.175|0.257|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference= UMEC/VI 125/25 µg minus Placebo.|||0.257|0.175|<0.001
91752677|NCT02117349|183398217|OTHER||Odds Ratio (OR)|42.8|||=|0.001|TWO_SIDED|95.0|4.58|401.0||Study was terminated early at 55 randomized subjects, therefore p-value is considered nominal|Regression, Logistic|||Odds Ratio (OR) and Wald-based 95% Confidence intervals (CIs) are from logistic regression model comparing the response between treatment arms.||401.0|4.58|= 0.0010
91752678|NCT02033213|183398226|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.410
91752679|NCT02033213|183398226|SUPERIORITY_OR_OTHER|||||||0.621||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.621
91752680|NCT02033213|183398227|SUPERIORITY_OR_OTHER|||||||0.791||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.791
91752681|NCT02033213|183398227|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.410
91752682|NCT02033213|183398228|SUPERIORITY_OR_OTHER|||||||0.322||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement aws assessed at 10 minutes time point.||||0.322
91752683|NCT02033213|183398228|SUPERIORITY_OR_OTHER|||||||0.574||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.574
91752684|NCT02033213|183398229|SUPERIORITY_OR_OTHER|||||||0.03||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.030
91752685|NCT02033213|183398229|SUPERIORITY_OR_OTHER|||||||0.096||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.096
91752686|NCT02033213|183398230|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 1 sided|||||||0.362
91752687|NCT02033213|183398231|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.020
91752688|NCT03474081|183398232|SUPERIORITY||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.0167|<|0.001|TWO_SIDED|95.0|0.062|0.128||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.128|0.062|<0.001
91752689|NCT03474081|183398233|SUPERIORITY||Mean Difference (Net)|0.122|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.094|0.15||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.150|0.094|<0.001
91752690|NCT03474081|183398234|SUPERIORITY||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.0159|<|0.001|TWO_SIDED|95.0|0.056|0.118||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.118|0.056|<0.001
91752691|NCT01800318|183398283|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||RM Anova of effects of treatment groups on PIPP scores: .|ANOVA|||||||0.07
91752692|NCT01800318|183398283|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and sham NESAP.||||<0.05
91752693|NCT01800318|183398283|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with NESAP and oral water.||||<0.01
91507461|NCT00653224|182886853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.003||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.003
91507462|NCT00653224|182886854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
91507463|NCT00653224|182886855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001||95.0|-0.57|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.57|<0.001
91507464|NCT00653224|182886856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
91752694|NCT01800318|183398283|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and NESAp combined.||||<0.05
91752695|NCT01800318|183398283|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni||t test comparing baseline PIPP score with heel stick PIPP scores in standard care group (Sham NESAP with oral water).||||<0.01
91752696|NCT01800318|183398284|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
91752697|NCT01800318|183398285|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
91752698|NCT01800318|183398287|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANOVA|F4.048||||||0.008
91507465|NCT00653224|182886857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.59|<0.001
91507466|NCT00653224|182886858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0|-0.55|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.55|<0.001
91507467|NCT00653224|182886859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.59|<0.001
91507468|NCT00653224|182886860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.21|-0.63|<0.001
91752699|NCT00262847|183398288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.448||95.0|0.844|1.078|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.078|0.844|0.448
91752700|NCT00262847|183398288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.765|||<|0.001||95.0|0.676|0.866|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||0.866|0.676|<0.001
91752701|NCT00262847|183398289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.069||||0.41||95.0|0.912|1.255|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.255|0.912|0.410
91752702|NCT00262847|183398289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.131||95.0|0.746|1.039|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.039|0.746|0.131
91752703|NCT03495102|183398331|SUPERIORITY||Mean Difference (Net)|-0.17||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Mixed Models Analysis|||||-0.06|-0.29|0.003
91752704|NCT03495102|183398331|SUPERIORITY||Mean Difference (Net)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.45|-0.22|||Mixed Models Analysis|||||-0.22|-0.45|<0.001
91752705|NCT03495102|183398332|SUPERIORITY||Mean Difference (Net)|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||||-0.4|-1.4|0.001
91752706|NCT03495102|183398332|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.1|||Mixed Models Analysis|||||-1.1|-2.1|<0.001
91752707|NCT03495102|183398333|SUPERIORITY||Odds Ratio (OR)|1.49||||0.006|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||||1.98|1.12|0.006
91752708|NCT03495102|183398333|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.65|3.01|||Regression, Logistic|||||3.01|1.65|<0.001
91752709|NCT03495102|183398334|SUPERIORITY||Mean Difference (Net)|-3.7||||0.084|TWO_SIDED|95.0|-7.8|0.5|||Mixed Models Analysis|||||0.5|-7.8|0.084
91752710|NCT03495102|183398334|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-12.3|-3.9|||Mixed Models Analysis|||||-3.9|-12.3|<0.001
91752711|NCT03875664|183398359|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91752712|NCT05065190|183398372|OTHER||Adjusted difference|106.57|STANDARD_ERROR_OF_MEAN|76.84|||TWO_SIDED|95.0|-47.13|260.28|||||Adjusted difference between treatment groups was based on a random slope and intercept model with fixed effects for treatment, HRCT pattern, and baseline FVC \[mL\], and including treatment-by-time and baseline-by-time interactions.|||260.28|-47.13|
91752713|NCT03938324|183398381|SUPERIORITY|||||||0.0034||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.0034
91752714|NCT03938324|183398382|SUPERIORITY|||||||0.5137||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.5137
91507469|NCT00653224|182886861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001||95.0|-0.56|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.56|<0.001
91507470|NCT00653224|182886862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-0.63|<0.001
91507471|NCT00653224|182886863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|||<|0.001||95.0|-0.53|-0.13||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.53|<0.001
91507472|NCT00653224|182886864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.52|<0.001
91752715|NCT03938324|183398383|SUPERIORITY|||||||0.4107||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.4107
91507473|NCT00653224|182886865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.53|-0.14||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.14|-0.53|<0.001
91507474|NCT00653224|182886866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.32|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.32|<0.001
91507475|NCT00653224|182886867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001||95.0|-1.39|-0.36||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.36|-1.39|<0.001
91752716|NCT03938324|183398384|SUPERIORITY|||||||0.1708||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.1708
91752717|NCT03938324|183398385|SUPERIORITY|||||||0.7982||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.7982
91752718|NCT05160766|183398419|OTHER||Difference of means in percent|12.557|STANDARD_ERROR_OF_MEAN|5.661||0.03143|TWO_SIDED|95.0|1.168|23.946|||ANCOVA|||The statistical analysis reflects Part A of the study.||23.946|1.168|0.03143
91752719|NCT05160766|183398419|OTHER||Difference of means in percent|4.331|STANDARD_ERROR_OF_MEAN|1.671||0.0101|TWO_SIDED|95.0|1.04|7.621|||ANCOVA|||This statistical analysis reflects Part B of the study.||7.621|1.04|0.0101
91752720|NCT05160766|183398420|OTHER||Difference of means in percent|12.168|STANDARD_ERROR_OF_MEAN|5.88||0.04405|TWO_SIDED|95.0|0.338|23.998|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|23.998|0.338|0.04405
91752721|NCT05160766|183398420|OTHER||Difference of means in percent|14.212|STANDARD_ERROR_OF_MEAN|5.767||0.01744|TWO_SIDED|95.0|2.61|25.814|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|25.814|2.61|0.01744
91752722|NCT05160766|183398420|OTHER||Difference of means in percent|14.239|STANDARD_ERROR_OF_MEAN|5.932||0.02039|TWO_SIDED|95.0|2.305|26.173|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|26.173|2.305|0.02039
91752723|NCT05160766|183398420|OTHER||Difference of means in percent|9.331|STANDARD_ERROR_OF_MEAN|4.636||0.04989|TWO_SIDED|95.0|0.005|18.656|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|18.656|0.005|0.04989
91752724|NCT05160766|183398420|OTHER||Difference of means in percent|10.312|STANDARD_ERROR_OF_MEAN|4.373||0.02259|TWO_SIDED|95.0|1.514|19.111|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|19.111|1.514|0.02259
91752725|NCT05160766|183398420|OTHER||Difference of means in percent|11.601|STANDARD_ERROR_OF_MEAN|4.634||0.01583|TWO_SIDED|95.0|2.279|20.924|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|20.924|2.279|0.01583
91752726|NCT05160766|183398420|OTHER||Difference of means in percent|11.863|STANDARD_ERROR_OF_MEAN|4.323||0.00856|TWO_SIDED|95.0|3.166|20.56|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|20.56|3.166|0.00856
91752727|NCT05160766|183398420|OTHER||Difference of means in percent|6.83|STANDARD_ERROR_OF_MEAN|2.244||0.00258|TWO_SIDED|95.0|2.41|11.249|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|11.249|2.41|0.00258
91752728|NCT05160766|183398420|OTHER||Difference of means in percent|6.048|STANDARD_ERROR_OF_MEAN|2.244||0.00748|TWO_SIDED|95.0|1.63|10.466|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|10.466|1.63|0.00748
91752729|NCT05160766|183398420|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|2.782||0.00922|TWO_SIDED|95.0|1.821|12.782|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.782|1.821|0.00922
91752730|NCT05160766|183398420|OTHER||Difference of means in percent|4.791|STANDARD_ERROR_OF_MEAN|2.646||0.07136|TWO_SIDED|95.0|-0.419|10.001|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|10.001|-0.419|0.07136
91752731|NCT05160766|183398420|OTHER||Difference of means in percent|3.965|STANDARD_ERROR_OF_MEAN|2.196||0.07218|TWO_SIDED|95.0|-0.36|8.29|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|8.29|-0.36|0.07218
91752732|NCT05160766|183398420|OTHER||Difference of means in percent|4.82|STANDARD_ERROR_OF_MEAN|2.202||0.02949|TWO_SIDED|95.0|0.484|9.155|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|9.155|0.484|0.02949
91752733|NCT05160766|183398420|OTHER||Difference of means in percent|3.926|STANDARD_ERROR_OF_MEAN|2.263||0.08403|TWO_SIDED|95.0|-0.531|8.382|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|8.382|-0.531|0.08403
91752734|NCT05160766|183398423|OTHER||Difference of means in percent|8.835|STANDARD_ERROR_OF_MEAN|11.03||0.42797|TWO_SIDED|95.0|-13.475|31.145|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|31.145|-13.475|0.42797
91752735|NCT05160766|183398423|OTHER||Difference of means in percent|3.54|STANDARD_ERROR_OF_MEAN|10.575||0.73961|TWO_SIDED|95.0|-17.85|24.929|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|24.929|-17.85|0.73961
91752736|NCT05160766|183398423|OTHER||Difference of means in percent|8.086|STANDARD_ERROR_OF_MEAN|10.683||0.4537|TWO_SIDED|95.0|-13.524|29.695|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|29.695|-13.524|0.45370
91507476|NCT00653224|182886868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0|-1.2|-0.49||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.49|-1.20|<0.001
91507477|NCT00653224|182886869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.18|-0.35||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.35|-1.18|<0.001
91752737|NCT05160766|183398423|OTHER||Difference of means in percent|1.636|STANDARD_ERROR_OF_MEAN|10.187||0.87323|TWO_SIDED|95.0|-18.969|22.241|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|22.241|-18.969|0.87323
91507478|NCT00653224|182886870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.17|-0.45||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.17|<0.001
91507479|NCT00653224|182886871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.17|-0.31||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.31|-1.17|<0.001
91752738|NCT05160766|183398423|OTHER||Difference of means in percent|0.81|STANDARD_ERROR_OF_MEAN|9.848||0.93489|TWO_SIDED|95.0|-19.109|20.728|||ANCOVA|||This statistical analysis relfects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|20.728|-19.109|0.93489
91752739|NCT05160766|183398423|OTHER||Difference of means in percent|3.511|STANDARD_ERROR_OF_MEAN|10.845||0.74784|TWO_SIDED|95.0|-18.425|25.448|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|25.448|-18.425|0.74784
91752740|NCT05160766|183398423|OTHER||Difference of means in percent|2.088|STANDARD_ERROR_OF_MEAN|10.409||0.84202|TWO_SIDED|95.0|-18.966|23.143|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|23.143|-18.966|0.84202
91752741|NCT05160766|183398423|OTHER||Difference of means in percent|5.807|STANDARD_ERROR_OF_MEAN|4.068||0.15477|TWO_SIDED|95.0|-2.207|13.821|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|13.821|-2.207|0.15477
91752742|NCT05160766|183398423|OTHER||Difference of means in percent|3.52|STANDARD_ERROR_OF_MEAN|3.984||0.37773|TWO_SIDED|95.0|-4.327|11.368|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|11.368|-4.327|0.37773
91752743|NCT05160766|183398423|OTHER||Difference of means in percent|4.413|STANDARD_ERROR_OF_MEAN|4.18||0.29212|TWO_SIDED|95.0|-3.821|12.647|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.647|-3.821|0.29212
91752744|NCT05160766|183398423|OTHER||Difference of means in percent|5.961|STANDARD_ERROR_OF_MEAN|4.04||0.1414|TWO_SIDED|95.0|-1.998|13.919|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|13.919|-1.998|0.14140
91752745|NCT05160766|183398423|OTHER||Difference of means in percent|2.199|STANDARD_ERROR_OF_MEAN|3.875||0.5709|TWO_SIDED|95.0|-5.434|9.832|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|9.832|-5.434|0.57090
91507480|NCT00653224|182886872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.005||95.0|-1.26|-0.22||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-1.26|0.005
91507481|NCT00653224|182886873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.18|-0.3||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-1.18|<0.001
91752746|NCT05160766|183398423|OTHER||Difference of means in percent|6.528|STANDARD_ERROR_OF_MEAN|4.071||0.11012|TWO_SIDED|95.0|-1.491|14.548|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|14.548|-1.491|0.11012
91752747|NCT05160766|183398423|OTHER||Difference of means in percent|4.239|STANDARD_ERROR_OF_MEAN|4.06||0.29755|TWO_SIDED|95.0|-3.759|12.237|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|12.237|-3.759|0.29755
91752748|NCT05160766|183398428|OTHER||Difference of means in percent|9.64|STANDARD_ERROR_OF_MEAN|11.191||0.39426|TWO_SIDED|95.0|-12.995|32.275|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.2 (gamma)."|32.275|-12.995|0.39426
91507482|NCT00653224|182886874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0|-0.87|-0.3||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-0.87|<0.001
91507483|NCT00653224|182886875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.91|-0.24||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.24|-0.91|<0.001
91507484|NCT00653224|182886876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.86|-0.28||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.28|-0.86|<0.001
91507485|NCT00653224|182886877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.34|-0.13||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.34|<0.001
91507486|NCT00653224|182886878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.09||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.34|<0.001
91507487|NCT00653224|182886879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.33|-0.12||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.12|-0.33|<0.001
91507488|NCT00653224|182886880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.11||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.11|-0.32|<0.001
91507489|NCT00653224|182886881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.008||95.0|-0.3|-0.05||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.30|0.008
91507490|NCT00653224|182886882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.09||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.30|<0.001
91507491|NCT00653224|182886883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.384||95.0|-0.15|0.06||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.06|-0.15|0.384
91507492|NCT00653224|182886884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.063||95.0|-0.24|0.01||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.24|0.063
91752749|NCT05160766|183398428|OTHER||Difference of means in percent|8.764|STANDARD_ERROR_OF_MEAN|10.765||0.42055|TWO_SIDED|95.0|-13.011|30.539|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617."|30.539|-13.011|0.42055
91507493|NCT00653224|182886885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.124||95.0|-0.19|0.02||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.02|-0.19|0.124
91507494|NCT00653224|182886886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.002||95.0|-0.28|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.28|0.002
91507495|NCT00653224|182886887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.016||95.0|-0.28|-0.03||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.28|0.016
91507496|NCT00653224|182886888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.003||95.0|-0.27|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.27|0.003
91507497|NCT00653224|182886889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.088||95.0|-0.2|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.20|0.088
91507498|NCT00653224|182886890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.117||95.0|-0.23|0.03||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.03|-0.23|0.117
91507499|NCT00653224|182886891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.065||95.0|-0.21|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.21|0.065
91752750|NCT05160766|183398428|OTHER||Difference of means in percent|8.472|STANDARD_ERROR_OF_MEAN|10.953||0.44391|TWO_SIDED|95.0|-13.683|30.627|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|30.627|-13.683|0.44391
91752751|NCT05160766|183398428|OTHER||Difference of means in percent|8.483|STANDARD_ERROR_OF_MEAN|10.82||0.43775|TWO_SIDED|95.0|-13.402|30.368|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.3 (delta)."|30.368|-13.402|0.43775
91752752|NCT05160766|183398428|OTHER||Difference of means in percent|6.19|STANDARD_ERROR_OF_MEAN|9.892||0.53511|TWO_SIDED|95.0|-13.819|26.2|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|26.2|-13.819|0.53511
91752753|NCT05160766|183398428|OTHER||Difference of means in percent|4.552|STANDARD_ERROR_OF_MEAN|10.801||0.67576|TWO_SIDED|95.0|-17.295|26.399|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.3."|26.399|-17.295|0.67576
91752754|NCT05160766|183398428|OTHER||Difference of means in percent|8.438|STANDARD_ERROR_OF_MEAN|11.168||0.45443|TWO_SIDED|95.0|-14.15|31.027|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|31.027|-14.15|0.45443
91752755|NCT05160766|183398428|OTHER||Difference of means in percent|8.901|STANDARD_ERROR_OF_MEAN|10.218||0.38904|TWO_SIDED|95.0|-11.768|29.569|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|29.569|-11.768|0.38904
91752756|NCT05160766|183398428|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|10.11||0.47466|TWO_SIDED|95.0|-13.147|27.751|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|27.751|-13.147|0.47466
91752757|NCT05160766|183398428|OTHER||Difference of means in percent|2.878|STANDARD_ERROR_OF_MEAN|9.824||0.7711|TWO_SIDED|95.0|-16.993|22.749|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|22.749|-16.993|0.77110
91752758|NCT05160766|183398428|OTHER||Difference of means in percent|1.753||||0.86646|TWO_SIDED|95.0|-19.195|22.701|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|22.701|-19.195|0.86646
91507500|NCT00653224|182886892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
91507501|NCT00653224|182886893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.002||95.0|-0.33|-0.08||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.33|0.002
91752759|NCT05160766|183398428|OTHER||Difference of means in percent|5.42|STANDARD_ERROR_OF_MEAN|9.705||0.57972|TWO_SIDED|95.0|-14.21|25.049|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|25.049|-14.21|0.57972
91752760|NCT05160766|183398428|OTHER||Difference of means in percent|1.17|STANDARD_ERROR_OF_MEAN|9.408||0.90166|TWO_SIDED|95.0|-17.859|20.199|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.3 (omicron)."|20.199|-17.859|0.90166
91752761|NCT05160766|183398428|OTHER||Difference of means in percent|1.018|STANDARD_ERROR_OF_MEAN|10.44||0.92279|TWO_SIDED|95.0|-20.099|22.136|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BF.7 (omicron)."|22.136|-20.099|0.92279
91752762|NCT05160766|183398428|OTHER||Difference of means in percent|3.532|STANDARD_ERROR_OF_MEAN|9.496||0.71191|TWO_SIDED|95.0|-15.675|22.74|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|22.74|-15.675|0.71191
91752763|NCT05160766|183398428|OTHER||Difference of means in percent|2.995|STANDARD_ERROR_OF_MEAN|8.755||0.73415|TWO_SIDED|95.0|-14.714|20.703|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|20.703|-14.714|0.73415
91752764|NCT05160766|183398428|OTHER||Difference of means in percent|7.157|STANDARD_ERROR_OF_MEAN|9.548||0.45798|TWO_SIDED|95.0|-12.155|26.469|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|26.469|-12.155|0.45798
91752765|NCT05160766|183398428|OTHER||Difference of means in percent|4.819|STANDARD_ERROR_OF_MEAN|4.055||0.23582|TWO_SIDED|95.0|-3.169|12.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.2 (gamma)."|12.808|-3.169|0.23582
91752766|NCT05160766|183398428|OTHER||Difference of means in percent|5.312|STANDARD_ERROR_OF_MEAN|4.074||0.19354|TWO_SIDED|95.0|-2.713|13.337|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617."|13.337|-2.713|0.19354
91752767|NCT05160766|183398428|OTHER||Difference of means in percent|5.714|STANDARD_ERROR_OF_MEAN|4.155||0.17033|TWO_SIDED|95.0|-2.471|13.899|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|13.899|-2.471|0.17033
91752768|NCT05160766|183398428|OTHER||Difference of means in percent|5.934|STANDARD_ERROR_OF_MEAN|3.997||0.13895|TWO_SIDED|95.0|-1.94|13.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.3 (delta)."|13.808|-1.94|0.13895
91752769|NCT05160766|183398428|OTHER||Difference of means in percent|4.222|STANDARD_ERROR_OF_MEAN|3.812||0.26924|TWO_SIDED|95.0|-3.288|11.732|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|11.732|-3.288|0.26924
91752770|NCT05160766|183398428|OTHER||Difference of means in percent|5.49|STANDARD_ERROR_OF_MEAN|3.996||0.1708|TWO_SIDED|95.0|-2.382|13.362|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.3."|13.362|-2.382|0.17080
91752771|NCT05160766|183398428|OTHER||Difference of means in percent|5.567|STANDARD_ERROR_OF_MEAN|4.188||0.18502|TWO_SIDED|95.0|-2.683|13.818|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|13.818|-2.683|0.18502
91752772|NCT05160766|183398428|OTHER||Difference of means in percent|3.438|STANDARD_ERROR_OF_MEAN|3.938||0.38344|TWO_SIDED|95.0|-4.318|11.195|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|11.195|-4.318|0.38344
91752773|NCT05160766|183398428|OTHER||Difference of means in percent|3.279|STANDARD_ERROR_OF_MEAN|3.982||0.411|TWO_SIDED|95.0|-4.565|11.124|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|11.124|-4.565|0.41100
91752774|NCT05160766|183398428|OTHER||Difference of means in percent|2.67|STANDARD_ERROR_OF_MEAN|4.014||0.5066|TWO_SIDED|95.0|-5.237|10.577|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|10.577|-5.237|0.50660
91507502|NCT00653224|182886894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
91507503|NCT00653224|182886895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.30|<0.001
91752775|NCT05160766|183398428|OTHER||Difference of means in percent|4.535|STANDARD_ERROR_OF_MEAN|4.242||0.28604|TWO_SIDED|95.0|-3.82|12.891|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|12.891|-3.82|0.28604
91752776|NCT05160766|183398428|OTHER||Difference of means in percent|6.259|STANDARD_ERROR_OF_MEAN|3.98||0.11715|TWO_SIDED|95.0|-1.582|14.1|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|14.1|-1.582|0.11715
91752777|NCT05160766|183398428|OTHER||Difference of means in percent|3.818|STANDARD_ERROR_OF_MEAN|3.957||0.33567|TWO_SIDED|95.0|-3.978|11.613|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.3 (omicron)."|11.613|-3.978|0.33567
91752778|NCT05160766|183398428|OTHER||Difference of means in percent|5.775|STANDARD_ERROR_OF_MEAN|4.022||0.15232|TWO_SIDED|95.0|-2.147|13.697|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BF.7 (omicron)."|13.697|-2.147|0.15232
91752779|NCT05160766|183398428|OTHER||Difference of means in percent|4.808|STANDARD_ERROR_OF_MEAN|3.845||0.21234|TWO_SIDED|95.0|-2.766|12.383|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|12.383|-2.766|0.21234
91752780|NCT05160766|183398428|OTHER||Difference of means in percent|4.58|STANDARD_ERROR_OF_MEAN|3.78||0.22687|TWO_SIDED|95.0|-2.866|12.026|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|12.026|-2.866|0.22687
91752781|NCT05160766|183398428|OTHER||Difference of means in percent|3.498|STANDARD_ERROR_OF_MEAN|4.047||0.38832|TWO_SIDED|95.0|-4.475|11.47|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|11.47|-4.475|0.38832
91752782|NCT02408523|183398444|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.001|TWO_SIDED|95.0|0.377|0.774||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.774|0.377|<0.001
91752783|NCT02408523|183398445|SUPERIORITY||KM seizure free of LCM vs Placebo|14.1|||=|0.011|TWO_SIDED|95.0|3.2|25.1||Superiority of LCM vs Placebo p-value was based on a chi-square test on 1 degree of freedom.|Mantel Haenszel||Stratified difference in proportion of subjects who are seizure-free from PGTCS on Lacosamide (FAS) vs Placebo (FAS).|The key secondary efficacy variable was evaluated using an extended Mantel-Haenszel testing procedure. Baseline PGTCS Frequency from Combined Baseline and development (age from interactive response technology (IRT)) were calculated from IRT.||25.1|3.2|=0.011
91752784|NCT02408523|183398446|SUPERIORITY||Hazard Ratio (HR)|0.683|||=|0.012|TWO_SIDED|95.0|0.507|0.921||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.921|0.507|=0.012
91752785|NCT00996801|183398461|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.96||||0.012|TWO_SIDED|95.0|-3.58|-0.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.35|-3.58|0.012
91752786|NCT00996801|183398461|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.81||||0.019|TWO_SIDED|95.0|-3.37|-0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.25|-3.37|0.019
91752787|NCT00996801|183398461|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.82||||0.019|TWO_SIDED|95.0|-3.23|-0.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.41|-3.23|0.019
91752788|NCT00996801|183398462|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.64|||<|0.001|TWO_SIDED|95.0|-3.9|-1.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.38|-3.90|<0.001
91752789|NCT00996801|183398462|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.62|||<|0.001|TWO_SIDED|95.0|-3.83|-1.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.40|-3.83|<0.001
91752790|NCT00996801|183398462|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.12|||<|0.001|TWO_SIDED|95.0|-3.22|-1.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.02|-3.22|<0.001
91752791|NCT00996801|183398462|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.74||||0.376|TWO_SIDED|95.0|-1.99|0.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.52|-1.99|0.376
91752792|NCT00996801|183398462|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.71||||0.376|TWO_SIDED|95.0|-1.93|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-1.93|0.376
91752793|NCT00996801|183398462|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.22||||0.699|TWO_SIDED|95.0|-1.32|0.88||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.88|-1.32|0.699
91752794|NCT00996801|183398463|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.04||||0.002|TWO_SIDED|95.0|-3.43|-0.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.64|-3.43|0.002
91752795|NCT00996801|183398463|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.29||||0.035|TWO_SIDED|95.0|-2.48|-0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.09|-2.48|0.035
91752796|NCT00996801|183398463|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.76||||0.009|TWO_SIDED|95.0|-3.14|-0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.38|-3.14|0.009
91752797|NCT00996801|183398463|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.86||||0.335|TWO_SIDED|95.0|-2.26|0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.54|-2.26|0.335
91752798|NCT00996801|183398463|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.11||||0.857|TWO_SIDED|95.0|-1.3|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-1.30|0.857
91752799|NCT00996801|183398463|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.59||||0.542|TWO_SIDED|95.0|-1.96|0.79||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.79|-1.96|0.542
91752800|NCT00996801|183398464|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.24|||<|0.001|TWO_SIDED|95.0|-4.91|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.91|<0.001
91752801|NCT00996801|183398464|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.18|||<|0.001|TWO_SIDED|95.0|-4.78|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.78|<0.001
91752802|NCT00996801|183398464|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.66|-1.74||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.74|-4.66|<0.001
91752803|NCT00996801|183398464|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27||||0.18|TWO_SIDED|95.0|-2.93|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.93|0.180
91752804|NCT00996801|183398464|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.2||||0.18|TWO_SIDED|95.0|-2.81|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.81|0.180
91752805|NCT00996801|183398464|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.22||||0.18|TWO_SIDED|95.0|-2.68|0.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.23|-2.68|0.180
91752806|NCT00996801|183398465|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.36||||0.001|TWO_SIDED|95.0|-2.18|-0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.54|-2.18|0.001
91752807|NCT00996801|183398465|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.51||||0.001|TWO_SIDED|95.0|-2.46|-0.55||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.55|-2.46|0.001
91507504|NCT00653224|182886896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.006||95.0|-0.29|-0.05||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.29|0.006
91752808|NCT00996801|183398465|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.93|-0.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.91|-2.93|<0.001
91752809|NCT00996801|183398465|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.383|TWO_SIDED|95.0|-1.21|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-1.21|0.383
91507505|NCT00653224|182886897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
91507506|NCT00653224|182886898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||<|0.001||95.0|-0.31|-0.1||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.31|<0.001
91752810|NCT00996801|183398465|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.52||||0.383|TWO_SIDED|95.0|-1.49|0.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.45|-1.49|0.383
91752811|NCT00996801|183398465|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.94||||0.084|TWO_SIDED|95.0|-1.96|0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.09|-1.96|0.084
91752812|NCT00996801|183398466|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.68|TWO_SIDED|95.0|-1.88|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.88|0.680
91752813|NCT00996801|183398466|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.993|TWO_SIDED|95.0|-1.3|1.28||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.28|-1.30|0.993
91752814|NCT00996801|183398466|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.23|TWO_SIDED|95.0|-2.67|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-2.67|0.230
91752815|NCT00996801|183398466|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.84||||0.333|TWO_SIDED|95.0|-2.29|0.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.61|-2.29|0.333
91752816|NCT00996801|183398466|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.577|TWO_SIDED|95.0|-1.69|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.69|0.577
91752817|NCT00996801|183398466|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47||||0.078|TWO_SIDED|95.0|-3.07|0.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.12|-3.07|0.078
91752818|NCT00996801|183398467|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.99||||0.094|TWO_SIDED|95.0|-4.22|0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.25|-4.22|0.094
91752819|NCT00996801|183398467|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.66||||0.157|TWO_SIDED|95.0|-3.82|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-3.82|0.157
91752820|NCT00996801|183398467|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.57||||0.157|TWO_SIDED|95.0|-3.53|0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.38|-3.53|0.157
91752821|NCT00996801|183398467|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.43||||0.937|TWO_SIDED|95.0|-2.61|1.76||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.76|-2.61|0.937
91507507|NCT00653224|182886899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.011||95.0|-0.29|-0.04||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.29|0.011
91507508|NCT00653224|182886900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
91532545|NCT05677867|182941837|OTHER||Ratio of Geometric Adjusted Means|97.36|||||TWO_SIDED|90.0|92.77|102.17|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.17|92.77|
91532546|NCT05677867|182941838|OTHER||Ratio of Adjusted Means|94.7|||||TWO_SIDED|90.0|81.4|110.18|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||110.18|81.40|
91752822|NCT00996801|183398467|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.1||||0.992|TWO_SIDED|95.0|-2.21|2.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.01|-2.21|0.992
91752823|NCT00996801|183398467|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.992|TWO_SIDED|95.0|-1.93|1.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.90|-1.93|0.992
91752824|NCT00996801|183398468|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.824|TWO_SIDED|95.0|-2.5|1.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.56|-2.50|0.824
91752825|NCT00996801|183398468|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.42||||0.824|TWO_SIDED|95.0|-2.28|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-2.28|0.824
91752826|NCT00996801|183398468|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.96||||0.624|TWO_SIDED|95.0|-3.23|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-3.23|0.624
91752827|NCT00996801|183398468|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.78||||0.7|TWO_SIDED|95.0|-1.25|2.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.82|-1.25|0.700
91752828|NCT00996801|183398468|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.83||||0.7|TWO_SIDED|95.0|-1.39|3.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.06|-1.39|0.700
91752829|NCT00996801|183398468|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.3||||0.759|TWO_SIDED|95.0|-1.6|2.19||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.19|-1.60|0.759
91752830|NCT00996801|183398469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.22||||0.227|TWO_SIDED|95.0|-39.15|6.72||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||6.72|-39.15|0.227
91507509|NCT00653224|182886901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.004||95.0|-0.27|-0.05||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.27|0.004
91507510|NCT00653224|182886902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.1||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.34|<0.001
91507511|NCT00653224|182886903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
91507512|NCT00653224|182886904|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
91507513|NCT00653224|182886905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
91507514|NCT00653224|182886906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.027||95.0|-2.56|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-2.56|0.027
91507515|NCT00653224|182886907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.554||95.0|-1.56|0.84||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.84|-1.56|0.554
91513419|NCT02328326|182898549|SUPERIORITY||Mean Difference (Net)|0.07||||0.87|TWO_SIDED|95.0|-0.76|0.89|||Regression, Linear|Model adjusted for BL value of Blood Pressure Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.||0.89|-0.76|0.87
91513420|NCT02328326|182898550|SUPERIORITY||Mean Difference (Net)|-0.1||||0.56|TWO_SIDED|95.0|-0.42|0.23|||Regression, Linear|Model adjusted for BL value of Take Oral Meds as Prescribed, insulin use, randomization strat variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.||0.23|-0.42|0.56
91513421|NCT02328326|182898551|SUPERIORITY||Mean Difference (Net)|0.07||||0.67|TWO_SIDED|95.0|-0.26|0.41|||Regression, Linear|Model adjusted for baseline value of Take Insulin as Prescribed, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.||0.41|-0.26|0.67
91513422|NCT02328326|182898552|SUPERIORITY|The null hypothesis was that change (baseline to 12 months) in Foot Care is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Foot Care score compared to patient participants in PACT.|Median Difference (Net)|0.26||||0.29|TWO_SIDED|95.0|-0.22|0.75|||Regression, Linear|Model was adjusted for baseline value of Foot Care, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|||Net difference defined as 12 months minus baseline|0.75|-0.22|0.29
91507516|NCT00653224|182886908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.015||95.0|-2.72|-0.29||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.29|-2.72|0.015
91752831|NCT00996801|183398469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.85||||0.853|TWO_SIDED|95.0|-17.9|21.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.61|-17.90|0.853
91752832|NCT00996801|183398469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-13.14||||0.327|TWO_SIDED|95.0|-35.67|9.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.39|-35.67|0.327
91752833|NCT00996801|183398469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.74||||0.94|TWO_SIDED|95.0|-23.91|18.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||18.43|-23.91|0.940
91752834|NCT00996801|183398469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|15.33||||0.273|TWO_SIDED|95.0|-7.86|38.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||38.52|-7.86|0.273
91752835|NCT00996801|183398469|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.33||||0.973|TWO_SIDED|95.0|-19.23|19.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||19.90|-19.23|0.973
91752836|NCT00996801|183398470|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.48||||0.01|TWO_SIDED|95.0|-2.66|-0.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.29|-2.66|0.010
91752837|NCT00996801|183398470|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.14||||0.053|TWO_SIDED|95.0|-2.29|0.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.01|-2.29|0.053
91752838|NCT00996801|183398470|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.15||||0.053|TWO_SIDED|95.0|-2.19|-0.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.11|-2.19|0.053
91752839|NCT00996801|183398470|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.58||||0.509|TWO_SIDED|95.0|-1.77|0.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.60|-1.77|0.509
91752840|NCT00996801|183398470|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.25||||0.843|TWO_SIDED|95.0|-1.27|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.27|0.843
91752841|NCT00996801|183398470|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.26||||0.843|TWO_SIDED|95.0|-1.43|0.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.92|-1.43|0.843
91752842|NCT00996801|183398471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|86.33|||<|0.001|TWO_SIDED|95.0|64.87|108.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||108.29|64.87|<0.001
91752843|NCT00996801|183398471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|82.14|||<|0.001|TWO_SIDED|95.0|63.0|101.66||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||101.66|63.00|<0.001
91752844|NCT00996801|183398471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|107.26|||<|0.001|TWO_SIDED|95.0|82.03|133.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||133.23|82.03|<0.001
91752845|NCT00996801|183398471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.87||||0.104|TWO_SIDED|95.0|-3.8|49.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||49.68|-3.80|0.104
91752846|NCT00996801|183398471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|18.68||||0.123|TWO_SIDED|95.0|-5.11|42.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||42.56|-5.11|0.123
91752847|NCT00996801|183398471|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|43.8||||0.003|TWO_SIDED|95.0|12.85|75.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||75.06|12.85|0.003
91507517|NCT00653224|182886909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.016||95.0|-8.34|-0.86||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.86|-8.34|0.016
91507518|NCT00653224|182886910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.017||95.0|-7.88|-0.79||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.79|-7.88|0.017
91507519|NCT00653224|182886911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.25||||0.027||95.0|-8.02|-0.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.47|-8.02|0.027
91507520|NCT00653224|182886912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44||||0.023||95.0|-8.25|-0.63||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.63|-8.25|0.023
91507521|NCT00653224|182886913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.56||||0.015||95.0|-8.23|-0.89||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.89|-8.23|0.015
91507522|NCT00653224|182886914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.11||||0.036||95.0|-7.95|-0.27||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.27|-7.95|0.036
91507523|NCT00653224|182886915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.102||95.0|-9.95|0.93||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.93|-9.95|0.102
91532547|NCT04004208|182941858|NON_INFERIORITY|Non inferiority margin is 5%. Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.034|||||TWO_SIDED|90.0|-0.08|0.162||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.162|-0.08|
91752848|NCT00996801|183398472|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|187.31|||<|0.001|TWO_SIDED|95.0|154.44|221.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||221.25|154.44|<0.001
91752849|NCT00996801|183398472|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|200.29|||<|0.001|TWO_SIDED|95.0|161.21|240.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||240.91|161.21|<0.001
91752850|NCT00996801|183398472|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|224.3|||<|0.001|TWO_SIDED|95.0|180.19|270.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||270.39|180.19|<0.001
91752851|NCT00996801|183398472|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|48.29||||0.034|TWO_SIDED|95.0|3.75|93.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||93.11|3.75|0.034
91752852|NCT00996801|183398472|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|61.27||||0.019|TWO_SIDED|95.0|8.8|114.22||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||114.22|8.80|0.019
91752853|NCT00996801|183398472|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|85.28||||0.002|TWO_SIDED|95.0|26.7|144.63||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||144.63|26.70|0.002
91752854|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03|||<|0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|<0.001
91752855|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03||||0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|0.001
91752856|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|131.53|||<|0.001|TWO_SIDED|95.0|110.7|152.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||152.94|110.70|<0.001
91752857|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|169.8|||<|0.001|TWO_SIDED|95.0|141.59|199.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||199.11|141.59|<0.001
91752858|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|58.57|||<|0.001|TWO_SIDED|95.0|29.42|88.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||88.04|29.42|<0.001
91752859|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|57.07|||<|0.001|TWO_SIDED|95.0|30.76|83.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||83.64|30.76|<0.001
91752860|NCT00996801|183398473|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|95.34|||<|0.001|TWO_SIDED|95.0|60.4|130.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||130.91|60.40|<0.001
91752861|NCT00996801|183398474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.86|||<|0.001|TWO_SIDED|95.0|39.31|68.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||68.60|39.31|<0.001
91752862|NCT00996801|183398474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.81|||<|0.001|TWO_SIDED|95.0|41.37|66.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||66.38|41.37|<0.001
91752863|NCT00996801|183398474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|55.47|||<|0.001|TWO_SIDED|95.0|41.19|69.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||69.94|41.19|<0.001
91752864|NCT00996801|183398474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|20.53||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
91752865|NCT00996801|183398474|SUPERIORITY_OR_OTHER||Difference in Least Mean Squares|20.47||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
91752866|NCT00996801|183398474|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.13||||0.009|TWO_SIDED|95.0|4.47|39.89||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||39.89|4.47|0.009
91752867|NCT00289198|183398479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.256|||<|0.001|TWO_SIDED|95.0|-1.73|-0.78||Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate|ANCOVA|||||-0.78|-1.73|<0.001
91752868|NCT00289198|183398480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.459|||<|0.001|TWO_SIDED|95.0|-1.93|-0.99||Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate|ANCOVA|||||-0.99|-1.93|<0.001
91532548|NCT04004208|182941859|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|-0.023|||||TWO_SIDED|90.0|-0.11|0.046||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.046|-0.11|
91752869|NCT00289198|183398481|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|Based on logistic regression adjusting for age, gender and country||||||<0.001
91752870|NCT00289198|183398482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|||<|0.001|TWO_SIDED|95.0|-1.74|-0.81|||ANCOVA|||||-0.81|-1.74|<0.001
91752871|NCT00289198|183398483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.291|||<|0.001|TWO_SIDED|95.0|-1.77|-0.81|||ANCOVA|||||-0.81|-1.77|<0.001
91752872|NCT00289198|183398484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.118|||<|0.001|TWO_SIDED|95.0|-20.03|-8.21|||ANCOVA|||||-8.21|-20.03|<0.001
91752873|NCT00289198|183398485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.033|||<|0.001|TWO_SIDED|95.0|-27.13|-12.94|||ANCOVA|||||-12.94|-27.13|<0.001
91752874|NCT00289198|183398486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.14|-0.41|<0.001
91507524|NCT00653224|182886916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.493||95.0|-5.66|2.78||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||2.78|-5.66|0.493
91507525|NCT00653224|182886917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.117||95.0|-9.91|1.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||1.15|-9.91|0.117
91507526|NCT00653224|182886918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58||||0.409||95.0|-15.65|6.49||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.49|-15.65|0.409
91752875|NCT00289198|183398486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Nasal Congestion, Placebo vs Fluticasone furoate||-0.14|-0.42|<0.001
91507527|NCT00653224|182886919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.54||||0.432||95.0|-16.1|7.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||7.01|-16.10|0.432
91532549|NCT04004208|182941860|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.096|||||TWO_SIDED|90.0|0.019|0.175||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.175|0.019|
91532550|NCT02118714|182941887|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|80.0|10.7|41.6||||||||41.6|10.7|
91752876|NCT00289198|183398486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.331|||<|0.001|TWO_SIDED|95.0|-0.47|-0.2|||ANCOVA|||Nasal Itching, Placebo vs Fluticasone furoate||-0.20|-0.47|<0.001
91752877|NCT00289198|183398486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.27|-0.52|<0.001
91752878|NCT00289198|183398487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357||||0.001|TWO_SIDED|95.0|-0.5|-0.22|||ANCOVA|||Rhinorrhea score, Placebo versus fluticasone furoate||-0.22|-0.50|0.001
91752879|NCT00289198|183398487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.001|TWO_SIDED|95.0|-0.51|-0.23|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.23|-0.51|0.001
91752880|NCT00289198|183398487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
91752881|NCT00289198|183398487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
91752882|NCT00289198|183398488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.281||||0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Rhinorrhea score,Placebo versus fluticasone furoate||-0.14|-0.42|0.001
91752883|NCT00289198|183398488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.314||||0.001|TWO_SIDED|95.0|-0.45|-0.17|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.17|-0.45|0.001
91752884|NCT00289198|183398488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.324||||0.001|TWO_SIDED|95.0|-0.45|-0.19|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.19|-0.45|0.001
91752885|NCT00289198|183398488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374||||0.001|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.25|-0.50|0.001
91752886|NCT00289198|183398489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.292|||<|0.001||95.0|-0.43|-0.15|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.15|-0.43|<0.001
91752887|NCT00289198|183398489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.264|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||ANCOVA|||Nasal Congestion score, Placebo vs Fluticasone furoate||-0.12|-0.40|<0.001
91752888|NCT00289198|183398489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|||<|0.001|TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA|||Nasal Itching score, Placebo vs Fluticasone furoate||-0.20|-0.48|<0.001
91752889|NCT00289198|183398489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|||<|0.001|TWO_SIDED|95.0|-0.54|-0.28|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.28|-0.54|<0.001
91752890|NCT00289198|183398490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506||||0.004|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|||||-0.16|-0.85|0.004
91752891|NCT00289198|183398491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.491||||0.007||95.0|-0.85|-0.13|||ANCOVA|||||-0.13|-0.85|0.007
91752892|NCT00289198|183398492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.531||||0.003|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||||-0.19|-0.88|0.003
91507528|NCT00653224|182886920|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.24||||0.45||95.0|-15.46|6.99||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.99|-15.46|0.450
91507529|NCT00653224|182886921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.37||||0.251||95.0|-17.4|4.67||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||4.67|-17.40|0.251
91507530|NCT00653224|182886922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.06||||0.258||95.0|-19.48|5.36||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.36|-19.48|0.258
91507531|NCT00653224|182886923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.96||||0.288||95.0|-17.13|5.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.22|-17.13|0.288
91507532|NCT00653224|182886924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91|||<|0.001||95.0|-9.34|-2.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.47|-9.34|<0.001
91507533|NCT00653224|182886925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.62|||<|0.001||95.0|-9.88|-3.35||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-3.35|-9.88|<0.001
91507534|NCT00653224|182886926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69||||0.001||95.0|-9.16|-2.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.21|-9.16|0.001
91507535|NCT00653224|182886927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.027||95.0|-1.29|-0.08||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-1.29|0.027
91507536|NCT00653224|182886928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.535||95.0|-0.7|0.37||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.37|-0.70|0.535
91532551|NCT02118714|182941887|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|95.0|6.8|49.9||||||||49.9|6.8|
91532552|NCT02118714|182941888|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|80.0|3.2|28.4||||||||28.4|3.2|
91532553|NCT02118714|182941888|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|95.0|1.5|36.4||||||||36.4|1.5|
91532554|NCT02013687|182941913|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
91507537|NCT00653224|182886929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.042||95.0|-1.26|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-1.26|0.042
91507538|NCT00653224|182886930|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||If the p-value of this estimated difference is lower than 5% the change from baseline is considered as different between the two treatment groups.|Repeated measure analysis (CATMOD)|||The Null Hypothesis is expressed as follows: 'The change from baseline to endpoint visit in score category (ESS score \< 8 or \>= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||||0.171
91507539|NCT02896400|182886944|SUPERIORITY||Odds Ratio (OR)|1.8||||0.01|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|Adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including BNI (BNI only, BNI+NRT, BNI+QL, BNI+Text, BNI+NRT+QL, BNI+NRT+Text, BNI+QL+Text, BNI+NRT+QL+Text) compared to the 8 arms that do not include BNI (Control, NRT only, QL only, Text only, NRT+QL, NRT+Text, QL+Text, NRT+QL+Text)||2.8|1.1|.01
91507540|NCT02896400|182886944|SUPERIORITY||Odds Ratio (OR)|2.1||||0.001|TWO_SIDED|95.0|1.3|3.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms that include NRT (NRT only, BNI+NRT, NRT+QL, NRT+Text, BNI+NRT+QL, BNI+NRT+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include NRT (Control, BNI only, QL only, Text only, BNI+QL, BNI+Text, QL+Text, BNI+QL+Text)||3.2|1.3|.001
91507541|NCT02896400|182886944|SUPERIORITY||Odds Ratio (OR)|1.4||||0.14|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including QL intervention (QL only, BNI+QL, NRT+QL, QL+Text, BNI+NRT+QL, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to all 8 arms that did not include QL (Control, BNI only, NRT only, Text only, BNI+NRT, BNI+Text, NRT+Text, BNI+NRT+Text)||2.2|0.9|0.14
91507542|NCT02896400|182886944|SUPERIORITY||Odds Ratio (OR)|1.1||||0.64|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including Text (Text only, BNI+Text, NRT+Text, QL+Text, BNI+NRT+Text, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include Text (Control, BNI only, NRT only, QL only, BNI+NRT, BNI+QL, NRT+QL, BNI+NRT+QL)||1.7|0.7|0.64
91507543|NCT00394212|182886967|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.|Wilcoxon (Mann-Whitney)|||Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.||||0.066
91507544|NCT00394212|182886968|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.|Fisher Exact|||||||0.317
91507545|NCT00394212|182886969|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.019
91507546|NCT00394212|182886970|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.174
91507547|NCT02347527|182886972|SUPERIORITY|||||||0.038|||||||ANOVA|||||||0.038
91507548|NCT02347527|182886972|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
91507549|NCT02347527|182886973|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
91532555|NCT02013687|182941913|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
91507550|NCT02347527|182886974|OTHER|||||||0.04|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.040
91507551|NCT02347527|182886974|OTHER|||||||0.92|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.92
91507552|NCT01276314|182886982|OTHER|||||||0.01||||||The p-value was analyzed for SJS/TEN participants with \>10% body surface area detachment.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.01
91507553|NCT01276314|182886982|OTHER|||||||0.06||||||This p-value was analyzed for DRESS participants.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.06
91507554|NCT00749775|182887005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
91532556|NCT02013687|182941914|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91532557|NCT02013687|182941914|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
91532558|NCT02013687|182941915|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91532559|NCT02013687|182941915|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91752893|NCT00289198|183398493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496||||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||||-0.15|-0.84|0.005
91752894|NCT00289198|183398494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.001|TWO_SIDED|95.0|-0.34|-0.09|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.09|-0.34|0.001
91752895|NCT00289198|183398494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.137||||0.028|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye tearing/watering score, Placebo vs fluticasone furoate||-0.02|-0.26|0.028
91752896|NCT00289198|183398494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.156||||0.01|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Eye redness, Placebo vs fluticasone furoate||-0.04|-0.27|0.010
91752897|NCT00289198|183398495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.08|-0.35|0.002
91752898|NCT00289198|183398495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.016||95.0|-0.29|-0.03|||ANCOVA|||Eye tearing or watering, Placebo vs fluticasone furoate||-0.03|-0.29|0.016
91752899|NCT00289198|183398495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.076|TWO_SIDED|95.0|-0.24|-0.01|||ANCOVA|||Eye redness score, Placebo vs fluticasone furoate||-0.01|-0.24|0.076
91752900|NCT00289198|183398496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.211||||0.001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs Fluticasone furoate||-0.08|-0.34|0.001
91752901|NCT00289198|183398496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.023|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Eye tearing/watering, Placebo vs Fluticasone furoate||-0.02|-0.27|0.023
91752902|NCT00289198|183398496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.005|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||Eye Redness score, Placebo vs Fluticasone furoate||-0.05|-0.30|0.005
91752903|NCT00289198|183398497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.223||||0.001|TWO_SIDED|95.0|-0.35|-0.09|||ANCOVA|||Eye itching/burning, Placebo vs fluticasone furoate||-0.09|-0.35|0.001
91752904|NCT00289198|183398497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.04|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Eye Tearing/Watering score, Placebo vs fluticasone furoate||-0.01|-0.25|0.040
91752905|NCT00289198|183398497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142||||0.022|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye Redness score, Placebo vs fluticasone furoate||-0.02|-0.26|0.022
91752906|NCT00289198|183398498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.376||||0.004|TWO_SIDED|95.0|2.71|14.04|||ANCOVA|||||14.04|2.71|0.004
91532560|NCT01782326|182941916|NON_INFERIORITY_OR_EQUIVALENCE|Study was designed to have \>95% power to rule out a 1.15-fold increase in the rate exacerbations for QVA149 vs. salmeterol/fluticasone.|Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.96|||Generalized linear model||If the upper limit of the confidence interval was \<1.15 then non-inferiority of QVA149 compared to SFC could be claimed|||0.96|0.83|
91752907|NCT00289198|183398499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.28||||0.002|TWO_SIDED|95.0|3.52|15.04|||ANCOVA|||||15.04|3.52|0.002
91752908|NCT00289198|183398500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.638||||0.009|TWO_SIDED|95.0|1.89|13.39|||ANCOVA|||||13.39|1.89|0.009
91752909|NCT04172467|183398502|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|4.49|||<|0.001|TWO_SIDED|95.0|3.72|5.42||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||5.42|3.72|<0.001
91752910|NCT04172467|183398502|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|2.52|||<|0.001|TWO_SIDED|95.0|1.98|3.21||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||3.21|1.98|<0.001
91752911|NCT04332614|183398503|SUPERIORITY||Odds Ratio (OR)|0.8791371||||0.0248|TWO_SIDED|95.0|0.7856042|0.9838058||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9838058|0.7856042|0.0248
91752912|NCT04332614|183398503|SUPERIORITY||Odds Ratio (OR)|0.5980109|||<|0.0001|TWO_SIDED|95.0|0.5159511|0.6931219||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6931219|0.5159511|<0.0001
91507555|NCT00749775|182887005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
91507556|NCT00749775|182887005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
91507557|NCT00749775|182887005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
91507558|NCT00749775|182887006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
91507559|NCT00749775|182887006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
91507560|NCT00749775|182887006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
91507561|NCT00749775|182887006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
91532561|NCT01782326|182941916|SUPERIORITY_OR_OTHER||Rate Ratio|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Generalized linear method||If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1.|||0.96|0.83|0.003
91507562|NCT03064126|182887055|SUPERIORITY||Risk Difference (RD)|0.166||||0.0017|ONE_SIDED|97.5|0.0553||||Chi-squared||||||0.0553|0.0017
91507563|NCT03064126|182887056|NON_INFERIORITY|A Chi-Square Test was used to assess the hypothesis for the difference in 12-month MAE-free rate with non-inferiority margin (-10%).|Risk Difference (RD)|0.106|||<|0.0001|ONE_SIDED|97.5|0.0248||||Chi-squared||||||0.0248|<0.0001
91507564|NCT03907683|182887089|SUPERIORITY||Mean Difference (Final Values)|0.16412|STANDARD_ERROR_OF_MEAN|0.08||0.037|TWO_SIDED|95.0|0.0098|0.3185|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday move more messages would not differ from zero||0.3185|.0098|0.037
91507565|NCT03907683|182887089|SUPERIORITY||Mean Difference (Net)|0.12538|STANDARD_ERROR_OF_MEAN|0.07674||0.106|TWO_SIDED|95.0|-0.0274|0.2781|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday sit less messages would not differ from zero||0.2781|-0.0274|.106
91532562|NCT01782326|182941917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Regression, Cox|||||0.91|0.78|<0.001
91752913|NCT04332614|183398503|SUPERIORITY||Odds Ratio (OR)|0.8380003||||0.0133|TWO_SIDED|95.0|0.7285712|0.9638653||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9638653|0.7285712|0.0133
91507566|NCT03907683|182887089|SUPERIORITY||Mean Difference (Net)|0.24738|STANDARD_ERROR_OF_MEAN|0.13746||0.076|TWO_SIDED|95.0|-0.0262|0.521|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday inspirational quote messages would not differ from zero||.5210|-.0262|.076
91507567|NCT03907683|182887089|SUPERIORITY||Mean Difference (Net)|0.30563|STANDARD_ERROR_OF_MEAN|0.16136||0.062|TWO_SIDED|95.0|-0.0156|0.6268|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend move more messages would not differ from zero||.6268|-.0156|.062
91507568|NCT03907683|182887089|SUPERIORITY||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.10676||0.11|TWO_SIDED|95.0|0.0645|0.4895|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend sit less messages would not differ from zero||.4895|.0645|0.11
91507569|NCT03907683|182887089|SUPERIORITY||Mean Difference (Net)|0.10837|STANDARD_ERROR_OF_MEAN|0.16895||0.523|TWO_SIDED|95.0|-0.2279|0.4447|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend inspirational quote messages would not differ from zero||0.4447|-0.2279|.523
91507570|NCT03400332|182887113|OTHER||Hazard Ratio, log|0.94||||0.7416|TWO_SIDED|95.0|0.61|1.45|||Log Rank|||||1.45|0.61|0.7416
91507571|NCT00048542|182887119|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Chi-square test|||The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.||||0.031
91532563|NCT01782326|182941918|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91|||Generalized linear model|||||0.91|0.75|<0.001
91532564|NCT01782326|182941919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.86|||Regression, Cox|||||0.86|0.70|<0.001
91752914|NCT04332614|183398504|SUPERIORITY||Odds Ratio (OR)|0.3700794|||<|0.0001|TWO_SIDED|95.0|0.2870513|0.4771231||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4771231|0.2870513|<0.0001
91507572|NCT00048542|182887121|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-square test|||||||0.015
91507573|NCT00048542|182887122|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Log Rank|||||||0.029
91507574|NCT00048542|182887123|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Log Rank|||||||0.031
91507575|NCT00048542|182887124|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Pearson's Chi-square test|||||||0.061
91507576|NCT00048542|182887124|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
91507577|NCT00048542|182887125|SUPERIORITY_OR_OTHER|||||||0.103||95.0|||||Pearson's Chi-square test|||||||0.103
91507578|NCT00048542|182887125|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
91507579|NCT00048542|182887126|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Chi-square test|||||||0.156
91507580|NCT00048542|182887126|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Pearson's Chi-square test|||||||0.002
91507581|NCT02346136|182887173|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.62|TWO_SIDED|95.0|-0.62|0.37||Tested as two-tailed p\<0.025 to accommodate two co-primary outcomes|Mixed Models Analysis|||||0.37|-0.62|0.62
91532565|NCT01782326|182941924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.256|TWO_SIDED|95.0|0.74|1.08|||Regression, Cox|||||1.08|0.74|0.256
91532566|NCT01782326|182941925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.008|TWO_SIDED|95.0|0.69|0.95|||Regression, Cox|||||0.95|0.69|0.008
91752915|NCT04332614|183398504|SUPERIORITY||Odds Ratio (OR)|0.285144|||<|0.0001|TWO_SIDED|95.0|0.1881589|0.4321194||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4321194|0.1881589|<0.0001
91752916|NCT04332614|183398504|SUPERIORITY||Odds Ratio (OR)|0.5565905||||0.0003|TWO_SIDED|95.0|0.4059477|0.7631354||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.7631354|0.4059477|0.0003
91752917|NCT04332614|183398505|SUPERIORITY||Odds Ratio (OR)|0.72429741||||0.103|TWO_SIDED|95.0|0.49167734|1.0669736||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.0669736|0.49167734|0.103
91752918|NCT04332614|183398505|SUPERIORITY||Odds Ratio (OR)|0.63578603||||0.12|TWO_SIDED|95.0|0.35943749|1.1246013||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.1246013|0.35943749|0.120
91752919|NCT04332614|183398505|SUPERIORITY||Odds Ratio (OR)|1.06482385||||0.789|TWO_SIDED|95.0|0.67282661|1.6852036||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.6852036|0.67282661|0.789
91752920|NCT04332614|183398506|SUPERIORITY||Odds Ratio (OR)|0.8837908||||0.0286|TWO_SIDED|95.0|0.7912382|0.9871694||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9871694|0.7912382|0.0286
91752921|NCT04332614|183398506|SUPERIORITY||Odds Ratio (OR)|0.6000149|||<|0.0001|TWO_SIDED|95.0|0.5193168|0.6932528||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6932528|0.5193168|<0.0001
91752922|NCT04332614|183398506|SUPERIORITY||Odds Ratio (OR)|0.8225743||||0.0055|TWO_SIDED|95.0|0.7167043|0.9440832|||Regression, Logistic|||||0.9440832|0.7167043|0.0055
91752923|NCT04332614|183398507|SUPERIORITY||Odds Ratio (OR)|0.3948795|||<|0.0001|TWO_SIDED|95.0|0.310437|0.5022914||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.5022914|0.3104370|<0.0001
91752924|NCT04332614|183398507|SUPERIORITY||Odds Ratio (OR)|0.2790595|||<|0.0001|TWO_SIDED|95.0|0.1875017|0.4153254||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4153254|0.1875017|<0.0001
91752925|NCT04332614|183398507|SUPERIORITY||Odds Ratio (OR)|0.6097538||||0.0011|TWO_SIDED|95.0|0.4528751|0.8209762||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.8209762|0.4528751|0.0011
91752926|NCT04332614|183398508|SUPERIORITY||Odds Ratio (OR)|1.0049587||||0.976|TWO_SIDED|95.0|0.72693253|1.3893201||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.3893201|0.72693253|0.976
91752927|NCT04332614|183398508|SUPERIORITY||Odds Ratio (OR)|0.7576895||||0.246|TWO_SIDED|95.0|0.4741259|1.2108458||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.2108458|0.47412590|0.246
91752928|NCT04332614|183398508|SUPERIORITY||Odds Ratio (OR)|1.1728665||||0.428|TWO_SIDED|95.0|0.79090107|1.7393021||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.7393021|0.79090107|0.428
91752929|NCT04332614|183398509|SUPERIORITY||Odds Ratio (OR)|0.9980487||||1|TWO_SIDED|95.0|0.8680298|1.147543||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.147543|0.8680298|1
91752930|NCT04332614|183398509|SUPERIORITY||Odds Ratio (OR)|0.8953032||||0.276|TWO_SIDED|95.0|0.7771682|1.031395||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.031395|0.7771682|0.276
91752931|NCT04332614|183398509|SUPERIORITY||Odds Ratio (OR)|0.8970536||||0.289|TWO_SIDED|95.0|0.7785981|1.033531||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.033531|0.7785981|0.289
91752932|NCT04332614|183398510|SUPERIORITY||Odds Ratio (OR)|0.9313889||||0.94591|TWO_SIDED|95.0|0.6003591|1.444944||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.444944|0.6003591|0.94591
91752933|NCT04332614|183398510|SUPERIORITY||Odds Ratio (OR)|1.8998642||||0.0041|TWO_SIDED|95.0|1.2809137|2.817898||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.817898|1.2809137|0.0041
91532567|NCT01782326|182941926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.046|TWO_SIDED|95.0|0.66|1.0|||Regression, Cox|||||1.00|0.66|0.046
91752934|NCT04332614|183398510|SUPERIORITY||Odds Ratio (OR)|2.0398184||||0.0015|TWO_SIDED|95.0|1.3648075|3.048678||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||3.048678|1.3648075|0.0015
91752935|NCT04332614|183398511|SUPERIORITY||Odds Ratio (OR)|1.180837||||0.829|TWO_SIDED|95.0|0.6750639|2.065546||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.065546|0.6750639|0.829
91752936|NCT04332614|183398511|SUPERIORITY||Odds Ratio (OR)|1.432003||||0.404|TWO_SIDED|95.0|0.8279689|2.476702||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.476702|0.8279689|0.404
91752937|NCT04332614|183398511|SUPERIORITY||Odds Ratio (OR)|1.212702||||0.753|TWO_SIDED|95.0|0.7161724|2.05348||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.053480|0.7161724|0.753
91752938|NCT04332614|183398512|SUPERIORITY||Odds Ratio (OR)|0.9747188||||0.9284|TWO_SIDED|95.0|0.8501783|1.1175028||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.1175028|0.8501783|0.9284
91507582|NCT02346136|182887174|SUPERIORITY||Risk Ratio (RR)|0.535||||0.194|TWO_SIDED|95.0|0.182|1.57|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.57|0.182|0.194
91507583|NCT02346136|182887175|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.94||0.5|TWO_SIDED|95.0|-2.53|1.24|||Mixed Models Analysis|||||1.24|-2.53|.50
91507584|NCT02346136|182887176|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Gait NW velocity variable||.05|-.04|.85
91507585|NCT02346136|182887176|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.26|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|||Gait DT velocity variable||.06|-.02|.26
91507586|NCT02346136|182887177|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||0.03|-0.04|0.84
91507587|NCT02346136|182887178|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.71||0.26|TWO_SIDED|95.0|-0.61|2.22|||Mixed Models Analysis|||||2.22|-0.61|.26
91507588|NCT02346136|182887179|SUPERIORITY||Median Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|7.29||0.92|TWO_SIDED|95.0|-13.9|15.3|||Mixed Models Analysis|||||15.3|-13.9|.92
91507589|NCT02346136|182887180|SUPERIORITY||Median Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|9.28||0.88|TWO_SIDED|95.0|-17.2|19.9|||Mixed Models Analysis|||||19.9|-17.2|.88
91532568|NCT01782326|182941927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.79|TWO_SIDED|95.0|0.38|2.1|||Regression, Cox|||||2.10|0.38|0.790
91532569|NCT02303574|182941986|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.287|STANDARD_ERROR_OF_MEAN|0.05085|||TWO_SIDED|95.0|1.183|1.391||||||||1.391|1.183|
91752939|NCT04332614|183398512|SUPERIORITY||Odds Ratio (OR)|0.8518974||||0.0612|TWO_SIDED|95.0|0.741461|0.9787827||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||0.9787827|0.7414610|0.0612
91752940|NCT04332614|183398512|SUPERIORITY||Odds Ratio (OR)|0.873993||||0.1407|TWO_SIDED|95.0|0.7602296|1.0047804||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.0047804|0.7602296|0.1407
91752941|NCT04332614|183398513|SUPERIORITY||Odds Ratio (OR)|0.9089673||||0.8848|TWO_SIDED|95.0|0.6109603|1.352333||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.352333|0.6109603|0.8848
91752942|NCT04332614|183398513|SUPERIORITY||Odds Ratio (OR)|1.6914929||||0.0127|TWO_SIDED|95.0|1.1762411|2.43245||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.432450|1.1762411|0.0127
91752943|NCT04332614|183398513|SUPERIORITY||Odds Ratio (OR)|1.8608951||||0.0033|TWO_SIDED|95.0|1.2800275|2.705356||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.705356|1.2800275|0.0033
91507590|NCT02346136|182887181|SUPERIORITY||Mean Difference (Net)|0.85|STANDARD_ERROR_OF_MEAN|1.43||0.55|TWO_SIDED|95.0|-2.0|3.71|||Mixed Models Analysis|||Physical component score||3.71|-2.00|.55
91507591|NCT02346136|182887181|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.66||0.51|TWO_SIDED|95.0|-4.41|2.21|||Mixed Models Analysis|||Mental component score||2.21|-4.41|.51
91507592|NCT02346136|182887182|SUPERIORITY||Median Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED|95.0|-1.6|2.41|||Mixed Models Analysis|||||2.41|-1.60|.69
91507593|NCT02346136|182887183|SUPERIORITY||Mean Difference (Net)|2.14|STANDARD_ERROR_OF_MEAN|2.56||0.41|TWO_SIDED|95.0|-2.98|7.26||to accommodate two co-primary outcomes|Mixed Models Analysis|||||7.26|-2.98|0.41
91507594|NCT02346136|182887185|SUPERIORITY||Risk Ratio (RR)|0.476||||0.06|TWO_SIDED|95.0|0.216|1.05|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.05|0.216|0.060
91507595|NCT02346136|182887186|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.81||0.13|TWO_SIDED|95.0|-0.4|2.94|||Mixed Models Analysis|||||2.94|-0.40|0.13
91507596|NCT05619692|182887214|SUPERIORITY||Difference in LS Means|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1642|TWO_SIDED|95.0|-0.64|3.73||The p-value was obtained using MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MRMM||Difference was calculated as SAGE-718 - placebo.|||3.73|-0.64|0.1642
91507597|NCT02703636|182887251|OTHER|The MMRM model contained visit as a fixed effect, baseline MMSE score as a covariate and patient as a random effect.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.259||0.175|TWO_SIDED|95.0|-0.87|0.16|||t-test, 2 sided||change at week 24|||0.16|-0.87|0.1750
91507598|NCT00087633|182887261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.725|TWO_SIDED|95.0|-20.8|14.4|||Cochran-Mantel-Haenszel|||||14.4|-20.8|0.725
91507599|NCT03316885|182887265|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
91507600|NCT03316885|182887266|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
91507601|NCT02196324|182887289|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34|=|0.0111|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||||-0.2|-1.5|= 0.0111
91507602|NCT02196324|182887290|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43|=|0.0248|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||||-0.1|-1.8|= 0.0248
91507603|NCT02196324|182887291|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.47||0.0005|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|0.0005
91507604|NCT02196324|182887297|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.4|0.0||||||Week 2||-0.0|-1.4|
91507605|NCT02196324|182887297|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.7|-0.1||||||Week 4||-0.1|-1.7|
91507606|NCT02196324|182887297|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0175|TWO_SIDED|95.0|-2.0|-0.2||p-value assume equal variance|t-test, 2 sided|||Week 8||-0.2|-2.0|0.0175
91507607|NCT02196324|182887298|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.1|1.6||||||Week 2||1.6|-3.1|
91507608|NCT02196324|182887298|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.7|2.3||||||Week 4||2.3|-2.7|
91507609|NCT02196324|182887298|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-3.6|2.1||||||Week 8||2.1|-3.6|
91752944|NCT04332614|183398514|SUPERIORITY||Odds Ratio (OR)|0.8619131||||0.759|TWO_SIDED|95.0|0.5709078|1.301251||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.301251|0.5709078|0.759
91507610|NCT02196324|182887299|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||||||Week 2||0.1|-0.4|
91507611|NCT02196324|182887299|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2||||||Week 4||0.2|-0.4|
91752945|NCT04332614|183398514|SUPERIORITY||Odds Ratio (OR)|1.0950508||||0.897|TWO_SIDED|95.0|0.7331329|1.635633||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.635633|0.7331329|0.897
91752946|NCT04332614|183398514|SUPERIORITY||Odds Ratio (OR)|1.2704886||||0.498|TWO_SIDED|95.0|0.8377249|1.926816||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.926816|0.8377249|0.498
91507612|NCT02196324|182887299|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 8||0.1|-0.6|
91507613|NCT02196324|182887300|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.0625|TWO_SIDED|95.0|-0.02|0.72||p-value assume equal variance.|t-test, 2 sided|||||0.72|-0.02|0.0625
91507614|NCT00692770|182887312|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||=|0.258329|TWO_SIDED|95.0|0.78|1.134||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.134|0.78|=0.258329
91507615|NCT00692770|182887313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891|||=|0.121383|TWO_SIDED|95.0|0.735|1.081||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.081|0.735|=0.121383
91507616|NCT00692770|182887314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.995|||=|0.484742|TWO_SIDED|95.0|0.761|1.3||One-sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.3|0.761|=0.484742
91507617|NCT00692770|182887315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.0001|TWO_SIDED|95.0|0.025|0.052|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D index score. Statistical tests were performed with a 2 sided type I error of 5%.||0.052|0.025|<0.0001
91507618|NCT00692770|182887316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.978|||<|0.0001|TWO_SIDED|95.0|1.797|4.159|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D VAS score. Statistical tests were performed with a 2 sided type I error of 5%.||4.159|1.797|<0.0001
91507619|NCT00692770|182887317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.5|6.7|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-HEP score. Statistical tests were performed with a 2 sided type I error of 5%.||6.7|3.5|<0.0001
91507620|NCT00692770|182887318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.4|3.6|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-G score. Statistical tests were performed with a 2 sided type I error of 5%.||3.6|1.4|<0.0001
91507621|NCT00692770|182887319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.562|||||TWO_SIDED|95.0|1.241|1.965|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||1.965|1.241|
91507622|NCT00692770|182887320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.747|||||TWO_SIDED|95.0|1.407|2.17|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.170|1.407|
91507623|NCT00692770|182887321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|1.206|2.018|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.018|1.206|
91507624|NCT02984020|182887353|OTHER||Odds Ratio (OR)|0.77|||<|0.0001||95.0|0.69|0.86|||Regression, Logistic|Multiple logistic regression including total treatment duration of Xeljanz as factor||||0.86|0.69|<0.0001
91507625|NCT02984020|182887353|OTHER||Odds Ratio (OR)|2.43|||<|0.0001||95.0|1.64|3.59|||Regression, Logistic|Multiple logistic regression including other past/present disease as factor||||3.59|1.64|<0.0001
91507626|NCT02984020|182887364|OTHER||Odds Ratio (OR)|1.42||||0.0053|TWO_SIDED|95.0|1.11|1.82|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Xeljanz as factor||||1.82|1.11|0.0053
91507627|NCT01896895|182887365|SUPERIORITY||LS mean difference|-1.2|||=|0.0004|TWO_SIDED|95.0|-1.9|-0.6|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. First step of hierarchy is hypothesis of superiority of 50 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||-0.6|-1.9|=0.0004
91507628|NCT01896895|182887365|SUPERIORITY||LS mean difference|-0.5|||=|0.1452|TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. Second step of hierarchy is hypothesis of superiority of 25 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||0.2|-1.1|=0.1452
91507629|NCT00773175|182887396|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.5||||0.5064|TWO_SIDED|95.0|-221.2|86.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.2|-221.2|0.5064
91752947|NCT03369431|183398520|SUPERIORITY|||||||0.784|||||||t-test, 2 sided|||"Null hypothesis is that there is no difference in the percentage change from baseline in the ATEC Total between Vivomixx and Placebo.~A sample size of 72 participants was needed to determine an effect size of 0.50 with 80% power, with a type 1 error of 5% using a two-sided test. This calculation is based on the assumed effect size of the primary outcome measure, the ATEC. The minimally clinically important difference based on the primary outcome measure with this instrument was 15 points."||||0.784
91752948|NCT03369431|183398521|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Abdominal Pain between Vivomixx and Placebo.||||0.357
91752949|NCT03369431|183398521|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Gaseousness between Vivomixx and Placebo.||||0.290
91752950|NCT03369431|183398521|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Diarrhoea between Vivomixx and Placebo.||||0.418
91752951|NCT03369431|183398521|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Constipation between Vivomixx and Placebo.||||0.734
91752952|NCT03369431|183398521|SUPERIORITY|||||||0.362|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Pain on Stooling between Vivomixx and Placebo.||||0.362
91752953|NCT03369431|183398521|SUPERIORITY|||||||0.705|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Difficulty Swallowing between Vivomixx and Placebo.||||0.705
91752954|NCT03369431|183398521|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in change from baseline in frequency of vomiting between Vivomixx and placebo||||0.589
91752955|NCT03369431|183398521|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in stool between Vivomixx and placebo||||1.0
91752956|NCT03369431|183398521|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in vomit between Vivomixx and placebo||||1.0
91752957|NCT03369431|183398522|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline of ABC Irritability score between Vivomixx and Placebo||||0.635
91752958|NCT03369431|183398522|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||The null hypothesis is that there is no difference in the change from baseline of ABC Lethargy/social withdrawal score between Vivomixx and Placebo.||||0.367
91752959|NCT03369431|183398522|SUPERIORITY|||||||0.609|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in the ABC Stereotypic behaviour between Vivomixx and Placebo.||||0.609
91752960|NCT03369431|183398522|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|Paired samples t-test||Null hypothesis is that there is no difference in the change from baseline of the ABC Hyperactivity/Noncompliance between Vivomixx and Placebo.||||0.805
91752961|NCT03369431|183398522|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank test used.||Null hypothesis is that there is no difference in the change from baseline of the ABC Inappropriate Speech between Vivomixx and Placebo.||||0.985
91752962|NCT03369431|183398523|SUPERIORITY|||||||0.661|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||||||0.661
91752963|NCT01062061|183398525|SUPERIORITY_OR_OTHER|||||||0.9733||95.0|||||Chi-squared|||||||0.9733
91752964|NCT01062061|183398526|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Chi-squared|||||||0.0001
91507630|NCT00773175|182887396|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.0||||0.0325|TWO_SIDED|95.0|-54.6|102.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||102.7|-54.6|0.0325
91532570|NCT02303574|182941986|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|90.72|||||TWO_SIDED|90.0|83.72|98.31||||||||98.31|83.72|
91507631|NCT00773175|182887397|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-174.7||||0.8915|TWO_SIDED|95.0|-340.3|-9.1||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||-9.1|-340.3|0.8915
91507632|NCT00773175|182887397|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-58.6||||0.5469|TWO_SIDED|95.0|-137.5|20.3||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||20.3|-137.5|0.5469
91507633|NCT00773175|182887399|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.0||||0.5035|TWO_SIDED|95.0|-220.6|86.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.7|-220.6|0.5035
91532571|NCT02303574|182941987|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
91752965|NCT02937766|183398544|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.25||0.093|TWO_SIDED|95.0|-0.1|0.9|||t-test, 2 sided|The t-test tested the hypothesis of no treatment difference between treatment groups.||||0.9|-0.1|0.093
91752966|NCT02937766|183398545|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.234|TWO_SIDED|95.0|-0.2|0.7||The t-test tested the hypothesis of no treatment difference between treatment groups.|t-test, 2 sided|||||0.7|-0.2|0.234
91752967|NCT02753127|183398546|SUPERIORITY||Hazard Ratio (HR)|0.976||||0.3629|TWO_SIDED|95.0|0.854|1.117||1-sided|Log Rank|Based on stratified log-rank test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|"Based on Cox Proportional hazards model stratified by actual stratification factors including Time to progression on 1st line therapy, RAS mutation, and Bev as part of study treatment.~A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.117|0.854|0.3629
91752968|NCT02753127|183398546|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.3782|TWO_SIDED|95.0|0.797|1.179||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p value without multiplicity adjustment.|Hazard Ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin+ FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.179|0.797|0.3782
91752969|NCT02753127|183398547|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7307|TWO_SIDED|95.0|0.917|1.18||1-sided|Log Rank|"Based on stratified log rank test stratified by actual stratification factors~. P-value is nominal p-value without multiplicity adjustment."|"Based on Cox Proportional hazards model stratified by actual stratification~. A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.180|0.917|0.7307
91752970|NCT02753127|183398547|SUPERIORITY||Hazard Ratio (HR)|1.064||||0.7434|TWO_SIDED|95.0|0.883|1.283||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p-value without multiplicity adjustment.|Hazard ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox Proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin + FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.283|0.883|0.7434
91752971|NCT02753127|183398548|SUPERIORITY||rate difference|0.1||||0.4797|TWO_SIDED|95.0|-4.9|5.2||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment .|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||5.2|-4.9|0.4797
91752972|NCT02753127|183398548|SUPERIORITY||rate difference|-3.1||||0.783|TWO_SIDED|95.0|-11.0|4.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||4.7|-11.0|0.783
91752973|NCT02753127|183398549|SUPERIORITY||rate difference|-0.9||||0.6776|TWO_SIDED|95.0|-4.8|3.0||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||3.0|-4.8|0.6776
91752974|NCT02753127|183398549|SUPERIORITY||rate difference|-2.0||||0.7513|TWO_SIDED|95.0|-7.7|3.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||3.7|-7.7|0.7513
91752975|NCT00098722|183398554|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1802|||TWO_SIDED|97.5|-1.426|-0.616||||||The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.616|-1.426|
91507634|NCT00773175|182887399|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.6||||0.0314|TWO_SIDED|95.0|-54.0|103.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||103.2|-54.0|0.0314
91507635|NCT00773175|182887403|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
91507636|NCT00773175|182887403|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
91507637|NCT00773175|182887404|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
91507638|NCT00773175|182887404|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
91507639|NCT00773175|182887406|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.3|5.5|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||5.5|0.3|
91507640|NCT00773175|182887406|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-0.2|4.7|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||4.7|-0.2|
91507641|NCT00773175|182887407|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.8|1.9|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||1.9|-2.8|
91532572|NCT02303574|182941987|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
91532573|NCT02303574|182941987|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
91752976|NCT00098722|183398554|SUPERIORITY_OR_OTHER||LS mean difference|-1.042|STANDARD_ERROR_OF_MEAN|0.1786|||TWO_SIDED|97.5|-1.444|-0.64||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.640|-1.444|
91752977|NCT00098722|183398555|SUPERIORITY_OR_OTHER||LS mean difference|-0.961|STANDARD_ERROR_OF_MEAN|0.1856|||TWO_SIDED|97.5|-1.379|-0.544||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.544|-1.379|
91752978|NCT00098722|183398555|SUPERIORITY_OR_OTHER||LS mean difference|-1.109|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|97.5|-1.523|-0.695||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.695|-1.523|
91752979|NCT00098722|183398556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.56|8.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||8.23|2.56|<0.0001
91752980|NCT00098722|183398556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|3.35|10.78|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||10.78|3.35|<0.0001
91507642|NCT00773175|182887407|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||0.8|-3.4|
91507643|NCT00773175|182887418|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|0.1|0.3|||||Treatment difference = SC minus IV|||0.3|0.1|
91507644|NCT00773175|182887419|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0658|TWO_SIDED|95.0|-0.9|0.0|||ANOVA|From Analysis of Variance (ANOVA) model with center and treatment as factors.|Treatment difference = SC minus IV.|||0.0|-0.9|0.0658
91507645|NCT00773175|182887420|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6208|TWO_SIDED|95.0|-4.8|2.9|||ANOVA|From ANOVA model with center and treatment as factors|Treatment difference = SC minus IV|||2.9|-4.8|0.6208
91507646|NCT00773175|182887422|SUPERIORITY|||||||0.0685||||||Cochran-Mantel-Haenszel (CMH) test controlling for center|Cochran-Mantel-Haenszel|Question 1||||||0.0685
91507647|NCT00773175|182887422|SUPERIORITY|||||||0.0004||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||0.0004
91507648|NCT00773175|182887422|SUPERIORITY|||||||0.6861||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 3||||||0.6861
91507649|NCT00773175|182887422|SUPERIORITY|||||||0.2323||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.2323
91507650|NCT00773175|182887423|SUPERIORITY|||||||0.0033||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Effectiveness||||||0.0033
91507651|NCT00773175|182887423|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Degree of difficulty||||||< 0.0001
91507652|NCT00773175|182887424|SUPERIORITY|||||||0.2012||||||CMH test controlling for Center|Cochran-Mantel-Haenszel|Question 1||||||0.2012
91507653|NCT00773175|182887424|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||< 0.0001
91507654|NCT00773175|182887424|SUPERIORITY|||||||0.1302||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.1302
91507655|NCT00773175|182887424|SUPERIORITY|||||||0.0852||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 5||||||0.0852
91507656|NCT00773175|182887424|SUPERIORITY|||||||0.0275||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 6||||||0.0275
91507657|NCT00773175|182887430|SUPERIORITY|||||||0.0247|||||||Wilcoxon (Mann-Whitney)|||||||0.0247
91507658|NCT00773175|182887431|SUPERIORITY|||||||0.0007||||||CMH test controlling for center|Cochran-Mantel-Haenszel|||||||0.0007
91507659|NCT02775344|182887446|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.198|TWO_SIDED||||||Chi-squared, Corrected|||||||0.198
91507660|NCT02775344|182887447|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.393|TWO_SIDED||||||Chi-squared, Corrected|||||||0.393
91507661|NCT03909165|182887460|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.56|1.21||||||2 mg/kg AUC0-inf Geometric Mean Ratio (GMR) = Birth to 27 days AUC0-inf Geometric Mean (GM) / 28 days to \< 3 months AUC0-inf GM.||1.21|0.56|
91532574|NCT02303574|182941988|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.228|STANDARD_ERROR_OF_MEAN|0.1329|||TWO_SIDED|95.0|0.9513|1.504||||||||1.504|0.9513|
91532575|NCT02303574|182941988|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
91507662|NCT03909165|182887460|OTHER||Geometric Mean Ratio (GMR)|1.41|||||TWO_SIDED|90.0|1.0|1.98||||||2 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.98|1.00|
91507663|NCT03909165|182887460|OTHER||Geometric Mean Ratio (GMR)|0.82|||||TWO_SIDED|90.0|0.6|1.11||||||2 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.11|0.60|
91507664|NCT03909165|182887460|OTHER||Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||4 mg/kg AUC0-inf GMR = Birth to 27 days AUC0-inf GM / 28 days to \< 3 months AUC0-inf GM.||1.56|0.96|
91507665|NCT03909165|182887460|OTHER||Geometric Mean Ratio (GMR)|1.29|||||TWO_SIDED|90.0|1.03|1.62||||||4 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.62|1.03|
91507666|NCT03909165|182887460|OTHER||Geometric Mean Ratio (GMR)|0.89|||||TWO_SIDED|90.0|0.7|1.13||||||4 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.13|0.70|
91507667|NCT03909165|182887461|OTHER||Geometric Mean Ratio (GMR)|0.91|||||TWO_SIDED|90.0|0.67|1.23||||||2 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.23|0.67|
91507668|NCT03909165|182887461|OTHER||Geometric Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|0.92|1.69||||||2 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.69|0.92|
91507669|NCT03909165|182887461|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.64|1.08||||||2 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.08|0.64|
91507670|NCT03909165|182887461|OTHER||Geometric Mean Ratio (GMR)|0.86|||||TWO_SIDED|90.0|0.7|1.06||||||4 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.06|0.70|
91507671|NCT03909165|182887461|OTHER||Geometric Mean Ratio (GMR)|1.07|||||TWO_SIDED|90.0|0.89|1.29||||||4 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.29|0.89|
91507672|NCT03909165|182887461|OTHER||Geometric Mean Ratio (GMR)|0.97|||||TWO_SIDED|90.0|0.8|1.17||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.17|0.80|
91507673|NCT03909165|182887463|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.61|1.4||||||2 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.40|0.61|
91507674|NCT03909165|182887463|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.7|1.7||||||2 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||1.70|0.70|
91507675|NCT03909165|182887463|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.63|1.36||||||2 mg/kg Cmax GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.36|0.63|
91507676|NCT03909165|182887463|OTHER||Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.7|1.26||||||4 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.26|0.70|
91507677|NCT03909165|182887463|OTHER||Geometric Mean Ratio (GMR)|0.68|||||TWO_SIDED|90.0|0.52|0.89||||||4 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||0.89|0.52|
91507678|NCT03909165|182887463|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.83|1.43||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.43|0.83|
91507679|NCT03909165|182887468|SUPERIORITY||Hazard Ratio (HR)|2.4|||=|0.0002|TWO_SIDED|95.0|1.37|4.18||Two-sided p-value based on log-rank test stratified by neuromuscular blocking agent and age groups.|Log Rank|||The Hazard Ratio (HR) for the pairwise comparison of Sugammadex 2 mg/kg vs. Neostigmine + (Glycopyrrolate or Atropine) was based on a Cox regression model with Efron's method of tie handling with covariates of treatment, age (continuous) and stratified by neuromuscular blocking agent.||4.18|1.37|= 0.0002
91507680|NCT03909165|182887469|OTHER||Difference in Percentage|7.6|||||TWO_SIDED|95.0|-14.2|29.5||||||The difference in percentage of participants with an AE in sugammadex 2 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||29.5|-14.2|
91507681|NCT03909165|182887469|OTHER||Difference in Percentage|5.9|||||TWO_SIDED|95.0|-13.5|26.7||||||The difference in percentage of participants with an AE in sugammadex 4 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||26.7|-13.5|
91507682|NCT06034496|182887471|SUPERIORITY|||||||0.012||||||CES main effect|ANOVA|||||||.012
91507683|NCT06034496|182887471|SUPERIORITY|||||||0.33||||||Session main effect|ANOVA|||||||.33
91507684|NCT06034496|182887471|SUPERIORITY|||||||0.85||||||Session (baseline, follow-up) x CES|ANOVA|||||||.85
91507685|NCT06034496|182887472|SUPERIORITY|||||||0.6||||||CES main effect|ANOVA|||||||.6
91507686|NCT06034496|182887472|SUPERIORITY|||||||0.9||||||Session main effect|ANOVA|||||||.9
91752981|NCT00098722|183398556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.25|7.2|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.20|2.25|<0.0001
91752982|NCT00098722|183398556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.47|7.85|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.85|2.47|<0.0001
91752983|NCT00098722|183398557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.69|||<|0.0001|TWO_SIDED|95.0|2.72|8.1|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.10|2.72|<0.0001
91752984|NCT00098722|183398557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.91|8.62|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.62|2.91|<0.0001
91752985|NCT00098722|183398557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.13|6.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.32|2.13|<0.0001
91752986|NCT00098722|183398557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.0001|TWO_SIDED|95.0|2.69|8.02|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.02|2.69|<0.0001
91752987|NCT00098722|183398558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|2.64|7.92|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.64|<0.0001
91752988|NCT00098722|183398558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|95.0|3.13|9.39|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||9.39|3.13|<0.0001
91752989|NCT00098722|183398558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.29|7.0|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.00|2.29|<0.0001
91752990|NCT00098722|183398558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.91|8.89|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.89|2.91|<0.0001
91752991|NCT00098722|183398559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|1.95|6.48|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.48|1.95|<0.0001
91752992|NCT00098722|183398559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.0005|TWO_SIDED|95.0|1.59|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio \>1 favors maraviroc.||5.23|1.59|0.0005
91752993|NCT00098722|183398559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.26|7.92|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.26|<0.0001
91752994|NCT00098722|183398559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.2|7.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.64|2.20|<0.0001
91752995|NCT00098722|183398561|SUPERIORITY_OR_OTHER||LS mean difference|47.94|STANDARD_ERROR_OF_MEAN|13.383|||TWO_SIDED|95.0|21.64|74.25||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||74.25|21.64|
91752996|NCT00098722|183398561|SUPERIORITY_OR_OTHER||LS mean difference|38.12|STANDARD_ERROR_OF_MEAN|13.313|||TWO_SIDED|95.0|11.96|64.28||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||64.28|11.96|
91507687|NCT06034496|182887472|SUPERIORITY|||||||0.05||||||CES x Session interaction|ANOVA|||||||.05
91507688|NCT06034496|182887473|SUPERIORITY|||||||0.26||||||CES main effect|ANOVA|||||||.26
91507689|NCT06034496|182887473|SUPERIORITY|||||||0.17||||||Session main effect|ANOVA|||||||.17
91507690|NCT06034496|182887473|SUPERIORITY|||||||0.73||||||CES x Session main effect|ANOVA|||||||.73
91752997|NCT00098722|183398561|SUPERIORITY_OR_OTHER||LS mean difference|52.15|STANDARD_ERROR_OF_MEAN|14.803|||TWO_SIDED|95.0|23.06|81.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||81.25|23.06|
91507691|NCT06034496|182887474|SUPERIORITY|||||||0.18||||||CES main effect|ANOVA|||||||.18
91752998|NCT00098722|183398561|SUPERIORITY_OR_OTHER||LS mean difference|58.46|STANDARD_ERROR_OF_MEAN|14.725|||TWO_SIDED|95.0|29.53|87.4||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||87.40|29.53|
91507692|NCT06034496|182887474|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
91507693|NCT06034496|182887474|SUPERIORITY|||||||0.53||||||CES main effect|ANOVA|||||||.53
91507694|NCT06034496|182887474|SUPERIORITY|||||||0.07||||||CES x Time interaction|ANOVA|||||||.07
91752999|NCT00098722|183398562|SUPERIORITY_OR_OTHER||LS mean difference|218.57|STANDARD_ERROR_OF_MEAN|71.225|||TWO_SIDED|95.0|78.59|358.54||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||358.54|78.59|
91753000|NCT00098722|183398562|SUPERIORITY_OR_OTHER||LS mean difference|133.22|STANDARD_ERROR_OF_MEAN|70.855|||TWO_SIDED|95.0|-6.03|272.47||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||272.47|-6.03|
91753001|NCT00098722|183398562|SUPERIORITY_OR_OTHER||LS mean difference|136.93|STANDARD_ERROR_OF_MEAN|57.85|||TWO_SIDED|95.0|23.24|250.62||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||250.62|23.24|
91753002|NCT00098722|183398562|SUPERIORITY_OR_OTHER||LS mean difference|140.25|STANDARD_ERROR_OF_MEAN|57.55|||TWO_SIDED|95.0|27.15|253.35||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||253.35|27.15|
91753003|NCT00098722|183398563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.29|0.56|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.56|0.29|<0.0001
91753004|NCT00098722|183398563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.23|0.46|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.46|0.23|<0.0001
91753005|NCT00098722|183398564|SUPERIORITY_OR_OTHER||LS mean difference|-0.876|STANDARD_ERROR_OF_MEAN|0.1534|||TWO_SIDED|95.0|-1.177|-0.575||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.575|-1.177|
91753006|NCT00098722|183398564|SUPERIORITY_OR_OTHER||LS mean difference|-0.882|STANDARD_ERROR_OF_MEAN|0.1521|||TWO_SIDED|95.0|-1.181|-0.584||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.584|-1.181|
91753007|NCT00098722|183398564|SUPERIORITY_OR_OTHER||LS mean difference|-0.855|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.189|-0.521||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.521|-1.189|
91753008|NCT00098722|183398564|SUPERIORITY_OR_OTHER||LS mean difference|-1.033|STANDARD_ERROR_OF_MEAN|0.1685|||TWO_SIDED|95.0|-1.364|-0.701||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.701|-1.364|
91753009|NCT02046070|183398578|OTHER|||||||0.4859|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.4859
91753010|NCT02046070|183398578|OTHER|||||||0.6757|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.6757
91753011|NCT02046070|183398579|OTHER|||||||0.9688|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR+PR rate=60% obtained using the one-sided Chi-Square test with alpha=0.10.||||0.9688
91753012|NCT05601102|183398617|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.41|||||||t-test, 2 sided|||||||.41
91753013|NCT05601102|183398618|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.01|||||||t-test, 2 sided|||Anxiety subscale analysis||||.01
91753014|NCT05601102|183398618|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.42|||||||t-test, 2 sided|||Depression subscale||||.42
91753015|NCT05601102|183398619|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.04|||||||t-test, 2 sided|||||||.04
91753016|NCT05601102|183398620|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.15|||||||t-test, 2 sided|||||||.15
91753017|NCT05601102|183398621|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.02|||||||t-test, 2 sided|||||||.02
91753018|NCT05601102|183398622|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.22|||||||t-test, 2 sided|||||||.22
91753019|NCT05601102|183398623|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.29|||||||t-test, 2 sided|||||||.29
91753020|NCT05601102|183398624|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
91753021|NCT05601102|183398625|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.6|||||||t-test, 2 sided|||||||.60
91753022|NCT05601102|183398626|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
91753023|NCT05601102|183398627|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed|||||<|0.001|||||||t-test, 2 sided|||||||<.001
91753024|NCT06504524|183398640|OTHER||Hazard Ratio (HR)|1.128|||=|0.615|TWO_SIDED|95.0|0.705|1.804|||Regression, Cox||IPTW hazard ratio (HR) were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.804|0.705|=0.615
91753025|NCT06504524|183398641|OTHER||Hazard Ratio (HR)|1.18|||=|0.4429|TWO_SIDED|95.0|0.85|1.64|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.64|0.85|=0.4429
91507695|NCT06034496|182887474|SUPERIORITY|||||||0.46||||||CES x Session|ANOVA|||||||.46
91507696|NCT06034496|182887474|SUPERIORITY|||||||0.01||||||Time x Session interaction|ANOVA|||||||.01
91507697|NCT06034496|182887474|SUPERIORITY|||||||0.29||||||CES x Time x Session interaction|ANOVA|||||||.29
91507698|NCT06034496|182887475|SUPERIORITY|||||||0.1||||||CES main effect|ANOVA|||||||.10
91507699|NCT06034496|182887475|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
91507700|NCT06034496|182887475|SUPERIORITY|||||||0.81||||||Session main effect|ANOVA|||||||.81
91507701|NCT06034496|182887475|SUPERIORITY|||||||0.4||||||CES x Time interaction|ANOVA|||||||.40
91507702|NCT06034496|182887475|SUPERIORITY|||||||0.35||||||CES x Session interaction|ANOVA|||||||.35
91507703|NCT06034496|182887475|SUPERIORITY|||||||0||||||Time x Session interaction|ANOVA|||||||.00
91507704|NCT06034496|182887475|SUPERIORITY|||||||0.4||||||CES x Time x Session interaction|ANOVA|||||||.40
91507705|NCT06034496|182887476|SUPERIORITY|||||||0.23||||||STAI-T CES main effect|ANOVA|||||||.23
91507706|NCT06034496|182887476|SUPERIORITY|||||||0.45||||||STAI-T Session main effect|ANOVA|||||||.45
91507707|NCT06034496|182887476|SUPERIORITY|||||||0.38||||||STAI-T CES x Session interaction|ANOVA|||||||.38
91507708|NCT06034496|182887476|SUPERIORITY|||||||0.4||||||STAI-S CES main effect|ANOVA|||||||.40
91507709|NCT06034496|182887476|SUPERIORITY|||||||0||||||STAI-S Time main effect|ANOVA|||||||.00
91532576|NCT02303574|182941988|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
91532577|NCT02303574|182941988|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
91532578|NCT02303574|182941989|OTHER||Slope|1.302|STANDARD_ERROR_OF_MEAN|0.05056|||TWO_SIDED|95.0|1.198|1.406||||||Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.||1.406|1.198|
91532579|NCT02303574|182941989|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|64.14|||||TWO_SIDED|90.0|55.07|74.7||||||||74.70|55.07|
91532580|NCT02303574|182941990|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.157|STANDARD_ERROR_OF_MEAN|0.1098|||TWO_SIDED|95.0|0.9285|1.385||||||||1.385|0.9285|
91532581|NCT00495469|182942054|OTHER|Tukey's trend test for dose response||||||0.003||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||||||0.003
91507710|NCT06034496|182887476|SUPERIORITY|||||||0||||||STAI-S Session main effect|ANOVA|||||||.00
91532582|NCT00495469|182942054|OTHER|Tukey's trend test for dose response||||||0.047||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.047
91507711|NCT06034496|182887476|SUPERIORITY|||||||0.2||||||STAI-S CES x Time interaction|ANOVA|||||||.20
91507712|NCT06034496|182887476|SUPERIORITY|||||||0.39||||||STAI-S CES x Session interaction|ANOVA|||||||.39
91507713|NCT06034496|182887476|SUPERIORITY|||||||0||||||STAI-S Session x Time interaction|ANOVA|||||||.00
91507714|NCT06034496|182887476|SUPERIORITY|||||||0.38||||||STAI-S CES x Time x Session interaction|ANOVA|||||||.38
91507715|NCT06034496|182887477|SUPERIORITY|||||||0.85||||||CES main effect|ANOVA|||||||.85
91507716|NCT06034496|182887477|SUPERIORITY|||||||0.69||||||Session main effect|ANOVA|||||||.69
91507717|NCT06034496|182887477|SUPERIORITY|||||||0.4||||||CES x Session interaction|ANOVA|||||||.4
91507718|NCT06034496|182887478|SUPERIORITY|||||||0.13||||||CES main effect|ANOVA|||||||.13
91507719|NCT06034496|182887478|SUPERIORITY|||||||0.26||||||Session main effect|ANOVA|||||||.26
91507720|NCT06034496|182887478|SUPERIORITY|||||||0.44||||||CES x Session interaction|ANOVA|||||||.44
91507721|NCT06034496|182887479|SUPERIORITY|||||||0.36||||||CES main effect|ANOVA|||||||.36
91507722|NCT06034496|182887479|SUPERIORITY|||||||0||||||Session main effect|ANOVA|||||||.00
91507723|NCT06034496|182887479|SUPERIORITY|||||||0.96||||||CES x Session interaction|ANOVA|||||||.96
91507724|NCT03277261|182887497|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.406|||<|0.0001|TWO_SIDED|95.0|0.268|0.615||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.615|0.268|<0.0001
91507725|NCT03277261|182887498|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.033|||<|0.0001|TWO_SIDED|95.0|0.019|0.058||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.058|0.019|<0.0001
91507726|NCT03277261|182887499|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.076|||<|0.0001|TWO_SIDED|95.0|0.056|0.104||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.104|0.056|<0.0001
91507727|NCT03277261|182887501|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|5.442|||<|0.0001|TWO_SIDED|95.0|3.536|8.375||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||8.375|3.536|<0.0001
91507728|NCT03277261|182887502|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|0.872|||=|0.4669|TWO_SIDED|95.0|0.603|1.261||Logistic regression model with treatment, region, baseline EDSS strata, and log-transformed baseline MRI counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Logistic Regression|||||1.261|0.603|=0.4669
91507729|NCT03277261|182887503|SUPERIORITY||Least squares mean difference|-0.072|||<|0.0001|TWO_SIDED|95.0|-0.107|-0.036||The model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures (MMRM)|||||-0.036|-0.107|<0.0001
91532583|NCT00495469|182942054|OTHER|Tukey's trend test for dose response||||||0.006||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.006
91532584|NCT00495469|182942054|OTHER|Tukey's trend test for dose response||||||0.085||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.085
91532585|NCT00495469|182942054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.085|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.085
91753026|NCT06504524|183398642|OTHER||Hazard Ratio (HR)|0.66|||=|0.12|TWO_SIDED|95.0|0.39|1.115|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.115|0.390|=0.120
91753027|NCT06504524|183398643|OTHER||Hazard Ratio (HR)|0.52|||=|0.0011|TWO_SIDED|95.0|0.38|0.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.71|0.38|=0.0011
91753028|NCT06504524|183398644|OTHER||Hazard Ratio (HR)|0.759|||=|0.503|TWO_SIDED|95.0|0.337|1.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.710|0.337|=0.503
91753029|NCT06504524|183398645|OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.26|0.57|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.57|0.26|<0.0001
91753030|NCT06504524|183398646|OTHER||Hazard Ratio (HR)|0.918|||=|0.706|TWO_SIDED|95.0|0.587|1.436|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.436|0.587|=0.706
91753031|NCT06504524|183398647|OTHER||Hazard Ratio (HR)|0.68|||=|0.0182|TWO_SIDED|95.0|0.52|0.88|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.88|0.52|=0.0182
91532586|NCT00495469|182942054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.006|TWO_SIDED|95.0|-0.95|-0.16||Pairwise comparison included for informational purposes and not controlled for multiplicity|ANCOVA|Change=Baseline+Treatment||||-0.16|-0.95|0.006
91532587|NCT00495469|182942054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.084|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.084
91532588|NCT00495469|182942054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.001|TWO_SIDED|95.0|-1.05|-0.28||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.28|-1.05|0.001
91532589|NCT00495469|182942054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.97|-0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.20|-0.97|0.003
91532590|NCT00495469|182942054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.337|TWO_SIDED|95.0|-0.58|0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.20|-0.58|0.337
91532591|NCT00495469|182942056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.039|TWO_SIDED|95.0|-1.67|-0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.04|-1.67|0.039
91532592|NCT00495469|182942056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.013|TWO_SIDED|95.0|-1.89|-0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.23|-1.89|0.013
91532593|NCT00495469|182942056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.131|TWO_SIDED|95.0|-1.46|0.19||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.19|-1.46|0.131
91532594|NCT00495469|182942056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.023|TWO_SIDED|95.0|-1.77|-0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.13|-1.77|0.023
91532595|NCT00495469|182942056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.007|TWO_SIDED|95.0|-1.95|-0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.32|-1.95|0.007
91532596|NCT00495469|182942056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.223|TWO_SIDED|95.0|-1.34|0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.32|-1.34|0.223
91532597|NCT00495469|182942057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.1||||0.005|TWO_SIDED|95.0|-40.9|-7.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-7.4|-40.9|0.005
91753032|NCT03859739|183398652|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.79|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 2.44 %.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
91753033|NCT03859739|183398652|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.97|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 7.60%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
91753034|NCT03859739|183398652|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.58|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 74.99%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
91507730|NCT03762083|182887505|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|81.9|||||ONE_SIDED|95.0|63.1|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% confidence interval (CI) for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||63.1|
91507731|NCT03762083|182887506|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 1.|85.7|||||TWO_SIDED|95.0|63.7|97.0||||||||97.0|63.7|
91507732|NCT03762083|182887507|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 2.|90.0|||||TWO_SIDED|95.0|68.3|98.8||||||||98.8|68.3|
91507733|NCT03762083|182887508|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 3.|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
91507734|NCT03762083|182887510|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|5.6|||||TWO_SIDED|95.0|0.1|27.3||||||||27.3|0.1|
91507735|NCT03762083|182887510|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0|
91753035|NCT03859739|183398652|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.78|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 87.41%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
91753036|NCT03859739|183398660|OTHER||Standard Error (SE)|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 0.25%.|The posterior probability (PP) that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
91753037|NCT03859739|183398660|OTHER||SE|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 65.41%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
91753038|NCT03859739|183398660|OTHER||SE|0.133|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.99%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
91753039|NCT03859739|183398660|OTHER||SE|0.163|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.98%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
91753040|NCT03523273|183398740|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91753041|NCT03523273|183398741|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
91753042|NCT02590562|183398797|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||F test|||||||<0.0001
91753043|NCT02590562|183398798|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||F test|||||||0.0108
91532598|NCT00495469|182942057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.0|||<|0.001|TWO_SIDED|95.0|-52.5|-17.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-17.4|-52.5|<0.001
91753044|NCT01457950|183398804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.06|4.36|||ANCOVA|||||4.36|2.06|<0.0001
91753045|NCT02963987|183398841|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91753046|NCT02963987|183398842|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
91753047|NCT02963987|183398843|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
91753048|NCT02337530|183398849|SUPERIORITY||Odds Ratio (OR)|1.37||||0.73|TWO_SIDED|95.0|0.28|7.01|||Fisher Exact|||||7.01|0.28|0.73
91753049|NCT02337530|183398849|SUPERIORITY||Odds Ratio (OR)|6.4||||0.01|TWO_SIDED|95.0|1.65|24.8|||Fisher Exact|||||24.8|1.65|0.01
91753050|NCT02337530|183398850|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.56|TWO_SIDED|95.0|0.42|1.6|||Log Rank|||||1.60|0.42|0.56
91753051|NCT02337530|183398850|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.44|TWO_SIDED|95.0|0.4|1.49|||Log Rank|||||1.49|0.40|0.44
91753052|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted difference|0.18|||||TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 29||0.46|-0.11|
91753053|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.34|0.17|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 57||0.17|-0.34|
91753054|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.08|||||TWO_SIDED|95.0|-0.37|0.2|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 85||0.20|-0.37|
91753055|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.23|||||TWO_SIDED|95.0|-0.5|0.04|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 113||0.04|-0.50|
91753056|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|0.03|||||TWO_SIDED|95.0|-0.26|0.32|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 141||0.32|-0.26|
91753057|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.13|||||TWO_SIDED|95.0|-0.41|0.15|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 169||0.15|-0.41|
91753058|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.12|||||TWO_SIDED|95.0|-0.38|0.13|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 197||0.13|-0.38|
91753059|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.04|||||TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 225||0.25|-0.32|
91753060|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|0.08|||||TWO_SIDED|95.0|-0.19|0.36|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 253||0.36|-0.19|
91753061|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|0.13|||||TWO_SIDED|95.0|-0.12|0.38|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 281||0.38|-0.12|
91753062|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.27|0.22|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 309||0.22|-0.27|
91753063|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.37|0.31|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 337||0.31|-0.37|
91753064|NCT00989235|183398853|SUPERIORITY_OR_OTHER||Adjusted Difference|0.23|||||TWO_SIDED|95.0|-0.09|0.55|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 365||0.55|-0.09|
91507736|NCT01203072|182887511|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified|Cochran-Armitage|||As the primary analysis, the dose-response relationship in the incidence of thromboembolic event was verified using the Cochran-Armitage test.||||<0.001
91753065|NCT00989235|183398854|SUPERIORITY_OR_OTHER||estimate of difference|0.4|||||TWO_SIDED|95.0|-17.2|18.0|||normal approximation|For 95% CI: normal approximation with continuity correction.||||18.0|-17.2|
91753066|NCT00989235|183398855|SUPERIORITY_OR_OTHER||estimate of difference|-8.6|||||TWO_SIDED|95.0|-20.3|3.2|||normal approximation|For 95% CI: normal approximation with continuity correction.||||3.2|-20.3|
91753067|NCT00989235|183398857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.45|1.69|||Cox proportional hazards model||Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.|Through Month 12||1.69|0.45|
91507737|NCT00559962|182887637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07|||ANOVA|||One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.||7.07|2.30|<0.001
91753068|NCT00989235|183398858|SUPERIORITY_OR_OTHER||estimate of difference|-1.1|||||TWO_SIDED|95.0|-12.9|10.7|||normal approximation|For 95% CI: normal approximation with continuity correction.||||10.7|-12.9|
91753069|NCT00989235|183398859|SUPERIORITY_OR_OTHER||estimate of difference|-7.7|||||TWO_SIDED|95.0|-22.6|7.3|||normal approximation|95% CI: normal approximation with continuity correction.||||7.3|-22.6|
91753070|NCT00989235|183398860|SUPERIORITY_OR_OTHER||estimate of difference|-10.6|||||TWO_SIDED|95.0|-31.1|10.0|||normal approximation|95% CI: normal approximation with continuity correction.||||10.0|-31.1|
91507738|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.92|||<|0.001|TWO_SIDED|95.0|2.27|7.57||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||7.57|2.27|<0.001
91507739|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07||(All comparisons)|ANOVA|||||7.07|2.30|<0.001
91507740|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91|||<|0.001|TWO_SIDED|95.0|1.73|6.1||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||6.10|1.73|<0.001
91507741|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|||<|0.001|TWO_SIDED|95.0|4.31|11.33||(All comparisons)|ANOVA|||||11.33|4.31|<0.001
91507742|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|1.58|5.72||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||5.72|1.58|<0.001
91507743|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||<|0.001|TWO_SIDED|95.0|4.22|11.11||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||11.11|4.22|<0.001
91507744|NCT00559962|182887638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.51|||<|0.001|TWO_SIDED|95.0|5.16|9.86||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||9.86|5.16|<0.001
91753071|NCT03249935|183398871|SUPERIORITY|||||||||||||||||Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.|Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.|||
91753072|NCT03249935|183398872|SUPERIORITY||Odds Ratio (OR)|0.75||||0.656|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic|||Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28||2.62|0.22|0.656
91753073|NCT03249935|183398872|SUPERIORITY||Odds Ratio (OR)|4.65||||0.197|TWO_SIDED|95.0|0.45|47.89|||Regression, Logistic|||Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.||47.89|0.45|0.197
91507745|NCT04382911|182887676|EQUIVALENCE|A 2x2 table was constructed among all patients with histopathologically identified endometriosis (true positive) to compare sensitivity for FES PET/MRI versus sensitivity of conventional MRI.||||||0.317|||||||McNemar|||||||0.317
91507746|NCT04382911|182887679|OTHER|A random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age) was performed. The investigators included physician as a random effect to account for physician-level correlation.|Slope|0.748||||0.24|TWO_SIDED||||||Pearson's Correlation Coefficient|||||||0.24
91507747|NCT04382911|182887679|OTHER|The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.|Slope|0.406||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91507748|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.|Slope|-0.0099|STANDARD_ERROR_OF_MEAN|0.01572||0.5291|TWO_SIDED|95.0|-0.04075|0.02095||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2|||0.02095|-0.04075|0.5291
91507749|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.|Slope|0.1329|STANDARD_ERROR_OF_MEAN|0.0174|<|0.001|TWO_SIDED|95.0|0.0988|0.1671||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2|||0.1671|0.09880|<0.001
91507750|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.|Slope|0.2016|STANDARD_ERROR_OF_MEAN|0.01812|<|0.0001|TWO_SIDED|95.0|0.166|0.2371||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting|||0.2371|0.1660|<.0001
91507751|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
91507752|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
91507753|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
91507754|NCT04521166|182887680|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
91507755|NCT01110915|182887710|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|97.5||2.5||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI \>=10%.||2.5||<0.0001
91507756|NCT01110915|182887711|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.0|||||||||||Farrington-Manning test|A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
91507757|NCT01110915|182887712|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.5|||<|0.0001|TWO_SIDED|95.0|-5.0|5.9||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||5.9|-5.0|<0.0001
91507758|NCT01110915|182887713|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.5||||0.001|ONE_SIDED|95.0|-6.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-6.1|0.0010
91507759|NCT01110915|182887714|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.1||||0.0001|ONE_SIDED|95.0|-4.6|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.6|0.0001
91507760|NCT01110915|182887715|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9||A priori threshold for statistical significance was 0.05.|exact test of binomial proportions|||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
91507761|NCT01110915|182887716|SUPERIORITY_OR_OTHER||Complication rate at 4 months|7.7|||<|0.05|ONE_SIDED|95.0||10.9||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit \>= 20%.||10.9||<0.05
91507762|NCT03985813|182887717|SUPERIORITY|||||||0.083||||||Threshold for significance P\<0.05|Chi-squared|||||||0.083
91507763|NCT03985813|182887718|SUPERIORITY||||||>|0.99||||||Threshold for statistical significance P\<0.05|Chi-squared|||||||>0.99
91507764|NCT02161718|182887725|SUPERIORITY||Hazard Ratio (HR)|0.91|STANDARD_ERROR_OF_MEAN|0.251||0.746|TWO_SIDED|95.0|0.53|1.56|||Log Rank|||||1.56|0.53|0.746
91507765|NCT02161718|182887726|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.372|TWO_SIDED|95.0|0.43|1.37|||Andersen-Gill Recurrent-Event Cox Model|||||1.37|0.43|0.372
91507766|NCT02161718|182887727|SUPERIORITY||Odds Ratio (OR)|0.99||||0.963|TWO_SIDED|95.0|0.56|1.73|||Regression, Logistic|||||1.73|0.56|0.963
91507767|NCT02350309|182887759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15||||0.0262|ONE_SIDED|95.0|-2.12|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-2.12|0.0262
91507768|NCT02350309|182887759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.48|||<|0.0001|ONE_SIDED|95.0|-4.46|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-4.46|<0.0001
91507769|NCT02350309|182887760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0215||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||0.0215
91507770|NCT02350309|182887760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
91507771|NCT02350309|182887760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
91532599|NCT00495469|182942057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.8||||0.001|TWO_SIDED|95.0|-46.9|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.9|0.001
91532600|NCT00495469|182942057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.5|||<|0.001|TWO_SIDED|95.0|-53.6|-19.5||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-19.5|-53.6|<0.001
91507772|NCT00207142|182887770|NON_INFERIORITY_OR_EQUIVALENCE|Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.|Difference in proportions|2.9||||||95.0|-9.8|15.5|||Normal approximation|||The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.||15.5|-9.8|
91507773|NCT00207142|182887771|SUPERIORITY_OR_OTHER||Difference in Proportions|5.0||||||95.0|-6.0|16.1|||Normal Approximation|||||16.1|-6.0|
91507774|NCT00207142|182887772|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||||95.0|0.5|1.88|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen.||1.88|0.50|
91507775|NCT00207142|182887773|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||||95.0|0.37|1.9|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen||1.90|0.37|
91507776|NCT00207142|182887774|SUPERIORITY_OR_OTHER||Difference in means at Week 48|7.0||||||95.0|-38.0|53.0|||Normal approximation|||||53|-38|
91532601|NCT00495469|182942057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.5||||0.001|TWO_SIDED|95.0|-46.3|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.3|0.001
91507777|NCT01554618|182887787|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.33||0.012|TWO_SIDED|95.0|-1.51|-0.19|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline HbA1c value (continuous) and baseline HbA1c by visit interaction as fixed effects, using an unstructured covariance matrix.||-0.19|-1.51|0.012
91507778|NCT01554618|182887790|SUPERIORITY||LS Mean Difference|-21.6|STANDARD_ERROR_OF_MEAN|13.7||0.119|TWO_SIDED|95.0|-49.0|5.7|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline fasting plasma glucose value, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting plasma glucose by visit interaction as fixed effects, using an unstructured covariance matrix.||5.7|-49.0|0.119
91507779|NCT01554618|182887791|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|1.189||0.307|TWO_SIDED|95.0|-3.59|1.15|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline body weight, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline body weight by visit interaction as fixed effects, using an unstructured covariance matrix.||1.15|-3.59|0.307
91507780|NCT01554618|182887792|SUPERIORITY||LS Mean Difference|94.9|STANDARD_ERROR_OF_MEAN|95.26||0.323|TWO_SIDED|95.0|-95.6|285.5|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline fasting insulin, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting insulin by visit interaction as fixed effects, using an unstructured covariance matrix.||285.5|-95.6|0.323
91507781|NCT01554618|182887793|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
91507782|NCT01554618|182887793|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c ≤ 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
91507783|NCT01554618|182887793|SUPERIORITY||Difference|22.7||||0.02|TWO_SIDED|95.0|6.5|39.0|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 7.0%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||39.0|6.5|0.020
91507784|NCT01554618|182887795|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.61||0.284|TWO_SIDED|95.0|-8.0|2.4|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in SBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline SBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline SBP by visit interaction as fixed effects, using an unstructured covariance matrix."||2.4|-8.0|0.284
91507785|NCT01554618|182887795|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.376|TWO_SIDED|95.0|-2.0|5.1|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in DBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline DBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline DBP by visit interaction as fixed effects, using an unstructured covariance matrix."||5.1|-2.0|0.376
91507786|NCT01554618|182887797|SUPERIORITY||LS Mean Difference|90.37|STANDARD_ERROR_OF_MEAN|69.207||0.211|TWO_SIDED|95.0|-57.27|238.0|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-B:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-B, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-B by visit interaction as fixed effects, using an unstructured covariance matrix."||238.00|-57.27|0.211
91507787|NCT01554618|182887797|SUPERIORITY||LS Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|6.173||0.289|TWO_SIDED|95.0|-19.8|6.29|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-S:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-S, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-S by visit interaction as fixed effects, using an unstructured covariance matrix."||6.29|-19.80|0.289
91507788|NCT01857063|182887810|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.01||||0.913|TWO_SIDED|95.0|-0.11|0.1||Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|Longitudinal Data Analysis (LDA)|||||0.10|-0.11|0.913
91507789|NCT01857063|182887812|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.953|TWO_SIDED|95.0|-0.17|0.16||Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.16|-0.17|0.953
91507790|NCT01857063|182887813|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.974|TWO_SIDED|95.0|-0.07|0.07||Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.07|-0.07|0.974
91753074|NCT03249935|183398872|SUPERIORITY||Odds Ratio (OR)|0.68||||0.058|TWO_SIDED|95.0|0.45|1.01|||Regression, Logistic|||Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.||1.01|0.45|0.058
91507791|NCT01857063|182887814|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.182|TWO_SIDED|95.0|-0.06|0.01||Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.01|-0.06|0.182
91507792|NCT01857063|182887815|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.161|TWO_SIDED|95.0|-0.01|0.05||Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.05|-0.01|0.161
91507793|NCT01205165|182887830|SUPERIORITY_OR_OTHER|||||||0||95.0||||P-value is calculated from Wilcoxon signed rank test to compare difference between baseline and week12|Wilcoxon signed rank test|||Baseline and Week 12||||0.00000
91507794|NCT00329407|182887854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.58|-3.14|||Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This was a within subject analysis. The null hypothesis was that there would be no significant difference in least squares means values obtained for the baseline and week 10 assessment weeks.||-3.14|-6.58|<0.0001
91507795|NCT00329407|182887855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|STANDARD_ERROR_OF_MEAN|2.7||0.001|ONE_SIDED|95.0||||There would a significant reduction in COWAT scores between baseline and Week 10.|Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This is a within subject comparison of COWAT scores botained for the baseline session and the Week 10 session. The null hypothesis is that there would be no difference between these scores.||||0.001
91507796|NCT00978068|182887856|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.59||||0.04|TWO_SIDED|95.0|0.36|0.97|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||0.97|0.36|0.04
91507797|NCT00978068|182887857|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cox Proportional-Hazards|||||||0.13
91507798|NCT00978068|182887858|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8||||0.87|TWO_SIDED|95.0|0.06|11.16|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||11.16|0.06|0.87
91507799|NCT00978068|182887859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.45|1.12|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||1.12|0.45|0.14
91507800|NCT00978068|182887860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.004|TWO_SIDED|95.0|0.14|0.68|||Cox Proportional-Hazards|Adjustment for repeated measures in same participant.|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||0.68|0.14|0.004
91507801|NCT00978068|182887861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.004|TWO_SIDED|95.0|0.22|0.76|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient.|Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.|||0.76|0.22|0.004
91507802|NCT02281552|182887876|NON_INFERIORITY|Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD - IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.|Least Square (LS) mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.17|0.69||||||Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.||0.69|0.17|
91507803|NCT01434290|182887893|SUPERIORITY|||||||0.19|||||||One sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.19
91507804|NCT01434290|182887893|SUPERIORITY|||||||0.08|||||||One sample z-test|one-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.08
91507805|NCT01434290|182887894|SUPERIORITY|||||||0.18|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.18
91532602|NCT00495469|182942057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8||||0.114|TWO_SIDED|95.0|-31.0|3.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||3.4|-31.0|0.114
91532603|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.757|TWO_SIDED|95.0|0.27|6.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<=6.5%)||6.06|0.27|0.757
91753075|NCT01229943|183398873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.12|TWO_SIDED|95.0|0.55|1.17||Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).|Log Rank|||Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).||1.17|0.55|0.12
91507806|NCT01434290|182887894|SUPERIORITY|||||||0.38|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.38
91507807|NCT01434290|182887899|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
91507808|NCT01434290|182887899|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
91507809|NCT01434290|182887899|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.09
91507810|NCT01434290|182887899|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Two-side significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.43
91507811|NCT01434290|182887900|SUPERIORITY|||||||0.39|||||||One-sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.39
91507812|NCT01434290|182887900|SUPERIORITY|||||||0.21|||||||One sample z-test|One-side significance level of 0.025||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.21
91507813|NCT01434290|182887901|SUPERIORITY|||||||0.44|||||||one sampe z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.44
91507814|NCT01434290|182887901|SUPERIORITY|||||||0.53|||||||One sample z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.53
91507815|NCT01434290|182887902|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.16
91507816|NCT01434290|182887902|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.03
91753076|NCT03780959|183398879|SUPERIORITY|||||||0.003|||||||Mantel Haenszel|Stratified by study center and the number of active joints at randomization||||||0.0030
91507817|NCT01434290|182887902|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.83
91507818|NCT01434290|182887902|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.86
91507819|NCT01399593|182887937|SUPERIORITY||Proportion difference|-3.9||||0.76|TWO_SIDED|95.0|-23.9|16.3|||Fisher Exact|||||16.3|-23.9|0.76
91507820|NCT02365636|182887990|SUPERIORITY||LSM difference from placebo|0.32||||0.13|TWO_SIDED|95.0|-0.094|0.726||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.726|-0.094|0.130
91507821|NCT02365636|182887990|SUPERIORITY||LSM difference from placebo|0.24||||0.245|TWO_SIDED|95.0|-0.167|0.652||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.652|-0.167|0.245
91507822|NCT02365636|182887991|SUPERIORITY||LSM difference from placebo|0.32||||0.128|TWO_SIDED|95.0|-0.093|0.735||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.735|-0.093|0.128
91753077|NCT03780959|183398880|SUPERIORITY|||||||0.0001|||||||Log Rank|||||||0.0001
91507823|NCT02365636|182887991|SUPERIORITY||LSM difference from placebo|0.27||||0.194|TWO_SIDED|95.0|-0.14|0.688||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.688|-0.140|0.194
91507824|NCT02365636|182887992|SUPERIORITY||LSM difference from placebo|0.28||||0.177|TWO_SIDED|95.0|-0.128|0.691||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.691|-0.128|0.177
91507825|NCT02365636|182887992|SUPERIORITY||LSM difference from placebo|0.2||||0.325|TWO_SIDED|95.0|-0.204|0.614||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.614|-0.204|0.325
91507826|NCT02365636|182887993|SUPERIORITY||LSM difference from placebo|0.29||||0.202|TWO_SIDED|95.0|-0.158|0.741||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.741|-0.158|0.202
91507827|NCT02365636|182887993|SUPERIORITY||LSM difference from placebo|0.457||||0.457|TWO_SIDED|95.0|-0.28|0.621||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.621|-0.280|0.457
91507828|NCT02365636|182887994|SUPERIORITY||Odds Ratio (OR)|0.92||||0.815|TWO_SIDED|95.0|0.456|1.856||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.856|0.456|0.815
91532604|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.58|TWO_SIDED|95.0|0.31|8.01||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<=6.5%)||8.01|0.31|0.580
91532605|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.881|TWO_SIDED|95.0|0.22|5.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<=6.5%)||5.73|0.22|0.881
91532606|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.382|TWO_SIDED|95.0|0.44|8.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<=6.5%)||8.75|0.44|0.382
91507829|NCT02365636|182887994|SUPERIORITY||Odds Ratio (OR)|1.05||||0.893|TWO_SIDED|95.0|0.52|2.117||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.117|0.520|0.893
91507830|NCT02365636|182887994|SUPERIORITY||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.357|1.55||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.550|0.357|0.430
91507831|NCT02365636|182887994|SUPERIORITY||Odds Ratio (OR)|1.02||||0.967|TWO_SIDED|95.0|0.494|2.088||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.088|0.494|0.967
91507832|NCT02365636|182887995|SUPERIORITY||LSM of difference with placebo|2.2||||0.251|TWO_SIDED|95.0|-1.55|5.92||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.92|-1.55|0.251
91507833|NCT02365636|182887995|SUPERIORITY||LSM difference from placebo|1.3||||0.495|TWO_SIDED|95.0|-2.46|5.07||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.07|-2.46|0.495
91507834|NCT02365636|182887995|SUPERIORITY||LSM difference from placebo|3.1||||0.123|TWO_SIDED|95.0|-0.84|7.06||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||7.06|-0.84|0.123
91507835|NCT02365636|182887995|SUPERIORITY||LSM difference from placebo|2.8||||0.16|TWO_SIDED|95.0|-1.12|6.77||5% level of significance.|miex model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||6.77|-1.12|0.160
91507836|NCT02365636|182887996|SUPERIORITY||LSM difference from placebo|1.3||||0.609|TWO_SIDED|95.0|-3.81|6.48||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||6.48|-3.81|0.609
91507837|NCT02365636|182887996|SUPERIORITY||LSM difference with placebo|2.1||||0.427|TWO_SIDED|95.0|-3.05|7.19||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||7.19|-3.05|0.427
91507838|NCT02365636|182887997|SUPERIORITY||LSM difference from placebo|0.2||||0.166|TWO_SIDED|95.0|-0.07|0.43||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.43|-0.07|0.166
91507839|NCT02365636|182887997|SUPERIORITY||LSM difference from placebo|0.3||||0.046|TWO_SIDED|95.0|0.0|0.51||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.51|0.00|0.046
91507840|NCT02365636|182887997|SUPERIORITY||LSM difference from placebo|0.2||||0.152|TWO_SIDED|95.0|-0.08|0.53||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.53|-0.08|0.152
91507841|NCT02365636|182887997|SUPERIORITY||LSM difference from placebo|0.1||||0.342|TWO_SIDED|95.0|-0.16|0.46||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.46|-0.16|0.342
91507842|NCT02365636|182887998|SUPERIORITY||LSM difference from placebo|0.2||||0.311|TWO_SIDED|95.0|-0.22|0.7||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.70|-0.22|0.311
91507843|NCT02365636|182887998|SUPERIORITY||LSM difference from placebo|0.3||||0.262|TWO_SIDED|95.0|-0.2|0.73||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.73|-0.20|0.262
91532607|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.409|TWO_SIDED|95.0|0.42|8.68||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<=6.5%)||8.68|0.42|0.409
91507844|NCT02365636|182887998|SUPERIORITY||LSM difference from placebo|0.5||||0.065|TWO_SIDED|95.0|-0.03|0.97||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.97|-0.03|0.065
91507845|NCT02365636|182887998|SUPERIORITY||LSM difference from placebo|0.3||||0.296|TWO_SIDED|95.0|-0.23|0.76||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.76|-0.23|0.296
91507846|NCT02365636|182887999|SUPERIORITY|||||||0.245||||||5% level of significance|Regression, Cox|||||||0.245
91507847|NCT02365636|182887999|SUPERIORITY|||||||0.304||||||5% level of significance|Regression, Cox|||||||0.304
91507848|NCT02365636|182888000|SUPERIORITY||LSM difference from placebo|-0.1||||0.556|TWO_SIDED|95.0|-0.61|0.33||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.33|-0.61|0.556
91507849|NCT02365636|182888000|SUPERIORITY||LSM difference from placebo|-0.2||||0.482|TWO_SIDED|95.0|-0.65|0.31||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.31|-0.65|0.482
91507850|NCT02365636|182888000|SUPERIORITY||LSM difference from placebo|-0.3||||0.333|TWO_SIDED|95.0|-0.81|0.28||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.28|-0.81|0.333
91507851|NCT02365636|182888000|SUPERIORITY||LSM difference from placebo|-0.1||||0.833|TWO_SIDED|95.0|-0.62|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.62|0.833
91507852|NCT02365636|182888001|SUPERIORITY||LSM difference from placebo|-0.2||||0.563|TWO_SIDED|95.0|-0.75|0.41||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.41|-0.75|0.563
91507853|NCT02365636|182888001|SUPERIORITY||LSM difference from placebo|-0.1||||0.804|TWO_SIDED|95.0|-0.64|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.64|0.804
91507854|NCT02365636|182888001|SUPERIORITY||LSM difference from placebo|0.1||||0.714|TWO_SIDED|95.0|-0.49|0.71||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.71|-0.49|0.714
91507855|NCT02365636|182888001|SUPERIORITY||LSM difference from placebo|0.0||||0.871|TWO_SIDED|95.0|-0.64|0.55||5% level of siignificance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.55|-0.64|0.871
91507856|NCT02583256|182888010|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
91507857|NCT02583256|182888010|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
91507858|NCT02583256|182888010|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
91507859|NCT02583256|182888010|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.18|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
91507860|NCT02583256|182888011|SUPERIORITY|Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
91507861|NCT02583256|182888011|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
91507862|NCT02583256|182888011|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
91507863|NCT02583256|182888011|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
91507864|NCT02583256|182888012|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.28|1.51||||||Comparison performed for strain A/H1N1.||1.51|1.28|
91507865|NCT02583256|182888012|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.99|1.14||||||Comparison performed for strain A/H3N2||1.14|0.99|
91507866|NCT02583256|182888012|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.27|1.58||||||Comparison performed for strain B/Yamagata.||1.58|1.27|
91507867|NCT02583256|182888012|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.22|1.51||||||Comparison performed for strain B/Victoria.||1.51|1.22|
91532608|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.795|TWO_SIDED|95.0|0.24|6.29||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<=6.5%)||6.29|0.24|0.795
91507868|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.07|1.32||||||Comparison performed for strain A/H1N1.||1.32|1.07|
91532609|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.765|TWO_SIDED|95.0|0.36|3.95||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7%)||3.95|0.36|0.765
91507869|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09||||||Comparison performed for strain A/H3N2.||1.09|0.90|
91507870|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.12|||||TWO_SIDED|95.0|1.01|1.25||||||Comparison performed for strain B/Yamagata.||1.25|1.01|
91532610|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.1|TWO_SIDED|95.0|0.82|9.09||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7%)||9.09|0.82|0.100
91507871|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.27||||||Comparison performed for strain B/Victoria.||1.27|0.98|
91507872|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.3|1.5||||||Comparison performed for strain A/H1N1.||1.5|1.3|
91753078|NCT04253587|183398882|EQUIVALENCE|The null hypothesis was no difference between mean change scores for time-points X conditions.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03|=|0.016|TWO_SIDED|95.0|-0.06|0.06||Mixed effects ANOVA applied family wise error for post-hoc tests according to a priori hypothesis|ANOVA|||||0.06|-0.06|= 0.016
91753079|NCT04253587|183398883|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|=|0.22|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|effect of condition (F1,20 = 1.616, p = 0.22), effect of time (F1,20 = 0.613, p = 0.44)||||0.03|-0.03|= 0.22
91753080|NCT04732949|183398888|OTHER||Hazard Ratio (HR)|1.06||||0.509|TWO_SIDED|95.0|0.89|1.27|||Cox proportional hazard model|||Hazard Ratio for time to hospital discharge - SNG001 vs Placebo||1.27|0.89|0.509
91753081|NCT04732949|183398889|OTHER||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.81|1.28|||Cox proportional hazard model|||Hazard Ratio for time to OSCI recovery - SNG001 vs Placebo||1.28|0.81|0.888
91753082|NCT04732949|183398890|OTHER||Odds Ratio (OR)|0.71||||0.161|TWO_SIDED|95.0|0.44|1.15|||Regression, Logistic|||Odds Ratio for progression to severe disease or death - SNG001 vs Placebo||1.15|0.44|0.161
91753083|NCT04732949|183398891|OTHER||Odds Ratio (OR)|0.85||||0.61|TWO_SIDED|95.0|0.45|1.61|||Regression, Logistic|||Odds Ratio for intubation or death - SNG001 vs Placebo||1.61|0.45|0.610
91753084|NCT04732949|183398892|OTHER||Odds Ratio (OR)|0.79||||0.544|TWO_SIDED|95.0|0.38|1.67|||Regression, Logistic|||Odds Ratio for death - SNG001 vs Placebo||1.67|0.38|0.544
91753085|NCT04732949|183398893|OTHER||Odds Ratio (OR)|1.18||||0.323|TWO_SIDED|95.0|0.85|1.64|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 7) - SNG001 vs Placebo||1.64|0.85|0.323
91753086|NCT04732949|183398893|OTHER||Odds Ratio (OR)|1.17||||0.406|TWO_SIDED|95.0|0.81|1.7|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 14) - SNG001 vs Placebo||1.70|0.81|0.406
91753087|NCT04732949|183398893|OTHER||Odds Ratio (OR)|0.96||||0.828|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 21) - SNG001 vs Placebo||1.43|0.64|0.828
91753088|NCT04732949|183398893|OTHER||Odds Ratio (OR)|0.92||||0.706|TWO_SIDED|95.0|0.61|1.4|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 28) - SNG001 vs Placebo||1.40|0.61|0.706
91753089|NCT04732949|183398894|OTHER||Odds Ratio (OR)|1.71||||0.101|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 7) - SNG001 vs Placebo||3.22|0.90|0.101
91753090|NCT04732949|183398894|OTHER||Odds Ratio (OR)|0.99||||0.942|TWO_SIDED|95.0|0.67|1.45|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 14) - SNG001 vs Placebo||1.45|0.67|0.942
91753091|NCT04732949|183398894|OTHER||Odds Ratio (OR)|0.96||||0.824|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 21) - SNG001 vs Placebo||1.35|0.68|0.824
91753092|NCT04732949|183398894|OTHER||Odds Ratio (OR)|0.92||||0.613|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 28) - SNG001 vs Placebo||1.28|0.66|0.613
91753093|NCT04732949|183398896|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||SNG001 vs Placebo||0.3|-0.1|0.410
91753094|NCT01023672|183398906|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||The analysis was done per protocol (n=17)||||0.003
91753095|NCT02905006|183398938|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
91753096|NCT02905006|183398938|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
91753097|NCT02905006|183398938|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
91753098|NCT02905006|183398938|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
91753099|NCT02905006|183398939|SUPERIORITY||Odds Ratio (OR)|21.43|||=|0.0001|TWO_SIDED|95.0|4.51|101.88|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||101.88|4.51|=0.0001
91753100|NCT02905006|183398939|SUPERIORITY||Odds Ratio (OR)|63.21|||<|0.0001|TWO_SIDED|95.0|12.9|309.83|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||309.83|12.90|<0.0001
91753101|NCT02905006|183398939|SUPERIORITY||Odds Ratio (OR)|62.35|||<|0.0001|TWO_SIDED|95.0|12.61|308.29|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||308.29|12.61|<0.0001
91753102|NCT02905006|183398939|SUPERIORITY||Odds Ratio (OR)|130.35|||<|0.0001|TWO_SIDED|95.0|24.5|693.51|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||693.51|24.50|<0.0001
91753103|NCT02905006|183398939|SUPERIORITY||Odds Ratio (OR)|69.4|||<|0.0001|TWO_SIDED|95.0|14.07|342.4|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||342.40|14.07|<0.0001
91507873|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.1||||||Comparison performed for strain A/H3N2.||1.1|0.9|
91507874|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.3|||||TWO_SIDED|95.0|1.2|1.4||||||Comparison performed for strain B/Yamagata.||1.4|1.2|
91507875|NCT02583256|182888013|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.32|||||TWO_SIDED|95.0|1.2|1.5||||||Comparison performed for strain B/Victoria.||1.5|1.2|
91507876|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|1.8|||||TWO_SIDED|95.0|-4.9|8.6||||||Comparison performed for strain A/H1N1.||8.6|-4.9|
91507877|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|0.9|||||TWO_SIDED|95.0|-5.6|7.3||||||Comparison performed for strain A/H3N2.||7.3|-5.6|
91507878|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|4.3|||||TWO_SIDED|95.0|-1.8|10.4||||||Comparison performed for strain B/Yamagata.||10.4|-1.8|
91507879|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|2.6|||||TWO_SIDED|95.0|-3.3|8.5||||||Comparison performed for strain B/Victoria.||8.5|-3.3|
91507880|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|9.67|||||TWO_SIDED|95.0|3.11|16.17||||||Comparison performed for strain A/H1N1.||16.17|3.11|
91507881|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|-3.95|||||TWO_SIDED|95.0|-10.02|2.15||||||Comparison performed for strain A/H3N2.||2.15|-10.02|
91507882|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|12.95|||||TWO_SIDED|95.0|6.73|19.12||||||Comparison performed for strain B/Yamagata.||19.12|6.73|
91532611|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.687|TWO_SIDED|95.0|0.38|4.3||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7%)||4.30|0.38|0.687
91532612|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.409|TWO_SIDED|95.0|0.5|5.52||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7%)||5.52|0.50|0.409
91532613|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81||||0.086|TWO_SIDED|95.0|0.86|9.15||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7%)||9.15|0.86|0.086
91532614|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.369|TWO_SIDED|95.0|0.52|5.88||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7%)||5.88|0.52|0.369
91507883|NCT02583256|182888014|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|8.36|||||TWO_SIDED|95.0|2.17|14.54||||||Comparison performed for strain B/Victoria.||14.54|2.17|
91753104|NCT02905006|183398940|SUPERIORITY||Odds Ratio (OR)|18.23|||=|0.0003|TWO_SIDED|95.0|3.79|87.76|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||87.76|3.79|=0.0003
91507884|NCT02530294|182888032|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
91507885|NCT02530294|182888033|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||<0.001
91507886|NCT02530294|182888034|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||< 0.001
91507887|NCT02530294|182888035|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
91507888|NCT02530294|182888036|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
91507889|NCT01948375|182888037|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91753105|NCT02905006|183398940|SUPERIORITY||Odds Ratio (OR)|39.6|||<|0.0001|TWO_SIDED|95.0|8.19|191.59|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||191.59|8.19|<0.0001
91753106|NCT02905006|183398940|SUPERIORITY||Odds Ratio (OR)|77.27|||<|0.0001|TWO_SIDED|95.0|15.19|392.93|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||392.93|15.19|<0.0001
91753107|NCT02905006|183398940|SUPERIORITY||Odds Ratio (OR)|141.99|||<|0.0001|TWO_SIDED|95.0|26.26|767.72|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||767.72|26.26|<0.0001
91753108|NCT02905006|183398940|SUPERIORITY||Odds Ratio (OR)|58.52|||<|0.0001|TWO_SIDED|95.0|11.89|288.0|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||288.00|11.89|<0.0001
91753109|NCT02905006|183398941|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
91753110|NCT02905006|183398941|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
91507890|NCT01948375|182888039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.007||95.0|1.26|4.4||For the comparison of direct effect of placebo needle and real needle, p=0.007|Generalized Estimating Equation|||||4.40|1.26|0.007
91507891|NCT01948375|182888040|SUPERIORITY_OR_OTHER||||||=|0.006||||||"for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.~t=-2.88 refers to the t value of t test."|t-test, 2 sided|||||||=0.006
91507892|NCT01948375|182888041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||=|0.048||95.0|1.01|2.64||For the comparison of direct effect of placebo needle and real needle, p=0.048|Generalized Estimating Equation|||||2.64|1.01|=0.048
91507893|NCT04537806|182888049|SUPERIORITY||Proc Genmod|0.0||||1|TWO_SIDED|95.0|-31.8|31.8|||Chi-squared||Estimates for treatment, and the corresponding 95% confidence interval (CI) were estimated using Proc Genmod method, with treatment as a factor and age groups as a covariate variable.|||31.8|-31.8|1.0000
91507894|NCT03019627|182888055|SUPERIORITY||difference in least square means|-3.83|||=|0.428|TWO_SIDED|95.0|-13.34|5.68|||ANCOVA|||Frequency statistical analysis||5.68|-13.34|=0.428
91507895|NCT03019627|182888055|SUPERIORITY||difference in least square means|0.16|||=|0.974|TWO_SIDED|95.0|-9.45|9.76|||ANCOVA|||Severity statistical analysis||9.76|-9.45|=0.974
91507896|NCT03019627|182888056|SUPERIORITY||Difference in least square means|-1.12|||=|0.783|TWO_SIDED|95.0|-9.14|6.91|||ANCOVA|||frequency statistical analysis - week 4||6.91|-9.14|=0.783
91507897|NCT03019627|182888056|SUPERIORITY||difference in least square means|-3.82|||=|0.461|TWO_SIDED|95.0|-14.1|6.41|||ANCOVA|||Frequency statistical analysis - week 8||6.41|-14.1|=0.461
91507898|NCT03019627|182888056|SUPERIORITY||difference in least square means|-15.3|||=|0.004|TWO_SIDED|95.0|-25.6|-4.97|||ANCOVA|||Frequency statistical analysis - week 12||-4.97|-25.6|=0.004
91507899|NCT03019627|182888056|SUPERIORITY||difference in least square means|2.55|||=|0.544|TWO_SIDED|95.0|-5.72|10.82|||ANCOVA|||Severity statistical analysis - week 4||10.82|-5.72|=0.544
91507900|NCT03019627|182888056|SUPERIORITY||difference in least square means|1.06|||=|0.837|TWO_SIDED|95.0|-9.12|11.24|||ANCOVA|||Severity statistical analysis - week 8||11.24|-9.12|=0.837
91507901|NCT03019627|182888056|SUPERIORITY||difference in least square means|-13.8|||=|0.007|TWO_SIDED|95.0|-23.7|3.88|||ANCOVA|||Severity statistical analysis - week 12||3.88|-23.7|=0.007
91507902|NCT03019627|182888057|SUPERIORITY||Difference in least square means|-0.7|||=|0.046|TWO_SIDED|95.0|-1.38|-0.01|||ANCOVA|||week 4||-0.01|-1.38|=0.046
91507903|NCT03019627|182888057|SUPERIORITY||Difference in least square means|-0.3|||=|0.425|TWO_SIDED|95.0|-1.05|0.44|||ANCOVA|||week 8||0.44|-1.05|=0.425
91753111|NCT02905006|183398941|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
91753112|NCT02905006|183398941|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
91753113|NCT02905006|183398941|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
91753114|NCT02905006|183398942|SUPERIORITY||Odds Ratio (OR)|32.65|||<|0.0001|TWO_SIDED|95.0|6.82|156.38|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||156.38|6.82|<0.0001
91753115|NCT02905006|183398942|SUPERIORITY||Odds Ratio (OR)|94.51|||<|0.0001|TWO_SIDED|95.0|18.54|481.86|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||481.86|18.54|<0.0001
91507904|NCT03019627|182888057|SUPERIORITY||Difference in least square means|-0.09|||=|0.788|TWO_SIDED|95.0|-0.76|0.58|||ANCOVA|||week 12||0.58|-0.76|=0.788
91507905|NCT03019627|182888058|SUPERIORITY||Difference in least square means|-0.71|||=|0.265|TWO_SIDED|95.0|-1.95|0.54|||ANCOVA|||week 4||0.54|-1.95|=0.265
91507906|NCT03019627|182888058|SUPERIORITY||Difference in least square means|-1.38|||=|0.026|TWO_SIDED|95.0|-2.59|-0.17|||ANCOVA|||week 8||-0.17|-2.59|=0.026
91507907|NCT03019627|182888058|SUPERIORITY||Difference in least square means|-0.6|||=|0.361|TWO_SIDED|95.0|-1.9|0.7|||ANCOVA|||week 12||0.70|-1.90|=0.361
91507908|NCT03019627|182888059|SUPERIORITY||Difference in least square means|-0.25|||=|0.323|TWO_SIDED|95.0|-0.76|0.25|||ANCOVA|||week 4||0.25|-0.76|=0.323
91507909|NCT03019627|182888059|SUPERIORITY||Difference in least square means|0.03|||=|0.908|TWO_SIDED|95.0|-0.55|0.62|||ANCOVA|||week 8||0.62|-0.55|=0.908
91507910|NCT03019627|182888059|SUPERIORITY||Difference in least square means|-0.12|||=|0.702|TWO_SIDED|95.0|-0.76|0.52|||ANCOVA|||week 12||0.52|-0.76|=0.702
91507911|NCT03019627|182888060|SUPERIORITY||Difference in least square means|5.75|||=|0.003|TWO_SIDED|95.0|2.02|9.48|||ANCOVA|||||9.48|2.02|=0.003
91507912|NCT01236196|182888061|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
91507913|NCT01236196|182888062|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
91753116|NCT02905006|183398942|SUPERIORITY||Odds Ratio (OR)|117.66|||<|0.0001|TWO_SIDED|95.0|22.08|626.89|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||626.89|22.08|<0.0001
91753117|NCT02905006|183398942|SUPERIORITY||Odds Ratio (OR)|280.76|||<|0.0001|TWO_SIDED|95.0|44.06|1789.24|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||1789.24|44.06|<0.0001
91753118|NCT02905006|183398942|SUPERIORITY||Odds Ratio (OR)|107.83|||<|0.0001|TWO_SIDED|95.0|20.82|558.57|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||558.57|20.82|<0.0001
91753119|NCT02905006|183398943|SUPERIORITY||||||=|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0001
91753120|NCT02905006|183398943|SUPERIORITY||||||=|0.0002|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0002
91753121|NCT02905006|183398943|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
91753122|NCT02905006|183398943|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
91753123|NCT02905006|183398943|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
91753124|NCT00824005|183399054|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.9||0.169|TWO_SIDED|95.0|-0.42|2.34||No adjustment for multiple comparisons|t-test, 2 sided|||Compare the change in the cell group to the change in the placebo group.||2.34|-0.42|0.169
91753125|NCT00824005|183399055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|23.9||0.856|TWO_SIDED|95.0|-10.05|12.07|||t-test, 2 sided|||Change in the difference of end systolic volume over time.||12.07|-10.05|0.856
91753126|NCT00824005|183399056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|22.3||0.835|TWO_SIDED|95.0|-12.5|10.1||Is the change in percent reversible defect the same between the two groups|t-test, 2 sided|||Change in percent of the defect that is reversible||10.1|-12.5|0.835
91753127|NCT00824005|183399059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.471|TWO_SIDED|95.0|-0.3|0.14|||t-test, 2 sided|||Difference in the change between the two groups||0.14|-0.30|0.471
91753128|NCT00824005|183399060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.784||0.227|TWO_SIDED|95.0|-0.66|0.16|||t-test, 2 sided|||Change in average improvement in Canadian Class Score over time between the two groups.||0.16|-0.66|0.227
91753129|NCT00824005|183399061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.845||0.361|TWO_SIDED|95.0|-0.56|0.21|||t-test, 2 sided|||Difference in the change in NYHA score between the two groups||0.21|-0.56|0.361
91753130|NCT00824005|183399062|SUPERIORITY_OR_OTHER||Difference in the proportion of particip|0.04|STANDARD_DEVIATION|0.045||0.28|TWO_SIDED|95.0|-0.01|0.09|||Chi-squared|||Difference in the change in anti-anginal meds across groups||0.09|-0.01|0.28
91753131|NCT00824005|183399063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|104.0|STANDARD_DEVIATION|409.0||0.302|TWO_SIDED|95.0|-95.0|303.0|||t-test, 2 sided|||Change in six minute walk distance||303|-95|0.302
91753132|NCT00824005|183399064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.7|STANDARD_DEVIATION|176.0||0.55|TWO_SIDED|95.0|-150.0|80.0|||t-test, 2 sided|||Difference in the change in BNP(reg) between cell and placebo group||80|-150|0.55
91753133|NCT00824005|183399065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.5|STANDARD_DEVIATION|31.2||0.198|TWO_SIDED|95.0|-5.03|23.93|||t-test, 2 sided|||Change in the difference of end diastolic volume between the two groups over time.||23.93|-5.03|0.198
91753134|NCT00824005|183399066|SUPERIORITY_OR_OTHER||Difference in the incidence rates|-0.047|STANDARD_ERROR_OF_MEAN|0.044||0.47|TWO_SIDED|95.0|-0.133|0.039|||t-test, 2 sided|||The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)||0.039|-0.133|0.47
91507914|NCT01236196|182888063|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
91507915|NCT01236196|182888064|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
91753135|NCT00824005|183399067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|8.4||0.7|TWO_SIDED|95.0|-4.78|3.36|||t-test, 2 sided|||Difference in the change between the two groups||3.36|-4.78|0.7
91753136|NCT03458702|183399088|EQUIVALENCE|It would be expected at baseline that there were no differences between groups.|||||>|0.05|||||||t-test, 2 sided|||||||>.05
91753137|NCT03458702|183399088|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA for TIME||||<0.001
91753138|NCT03458702|183399089|EQUIVALENCE|It would be expected at baseline there would be no difference between groups.|||||>|0.05|||||||ANOVA|||||||>.05
91753139|NCT03458702|183399089|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA: Condition x Time Interaction||||<0.001
91753140|NCT03458702|183399089|SUPERIORITY|||||||0.005|||||||ANOVA|||ANOVA: TIME||||0.005
91753141|NCT03458702|183399090|EQUIVALENCE|It would be hypothesized that there would not be a difference at baseline.|||||>|0.05|||||||ANOVA|||||||> .05
91753142|NCT03458702|183399090|SUPERIORITY|||||||0.042|||||||ANOVA|||ANOVA: CONDITION X TIME INTERACTION||||0.042
91753143|NCT03458702|183399090|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||ANOVA: TIME||||<0.001
91753144|NCT03458702|183399091|EQUIVALENCE|A difference at baseline was not expected.|||||>|0.05|||||||ANOVA|||||||>.05
91753145|NCT03458702|183399091|SUPERIORITY|||||||0.016|||||||ANOVA|||ANOVA: TIME||||0.016
91753146|NCT03458702|183399092|EQUIVALENCE|no difference is expected at baseline|||||>|0.05|||||||ANOVA|||||||>.05
91753147|NCT03458702|183399092|SUPERIORITY|||||||0.026|||||||ANOVA|||ANOVA:TIME||||0.026
91753148|NCT03458702|183399093|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<.05
91507916|NCT01802775|182888066|OTHER||Treatment Difference|-3.9|||||TWO_SIDED|95.0|-17.3|9.5||||||Treatment difference was edoxaban - clopidogrel. For the treatment difference, 95% Confidence interval was calculated using a normal approximation to the binomial distribution.||9.5|-17.3|
91507917|NCT02103478|182888101|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.144|||||TWO_SIDED|95.0|-3.165|2.876|||||Course 1|||2.876|-3.165|
91507918|NCT02103478|182888101|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.087|||||TWO_SIDED|95.0|-3.463|3.288|||||Course 2|||3.288|-3.463|
91507919|NCT02103478|182888101|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-2.588|||||TWO_SIDED|95.0|-6.074|0.899|||||Course 1|||0.899|-6.074|
91507920|NCT02103478|182888101|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.096|||||TWO_SIDED|95.0|-5.08|4.888|||||Course 2|||4.888|-5.080|
91532615|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.16|TWO_SIDED|95.0|0.74|6.4||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction\>=0.7%)||6.40|0.74|0.160
91532616|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87||||0.014|TWO_SIDED|95.0|1.31|11.42||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||11.42|1.31|0.014
91532617|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.162|TWO_SIDED|95.0|0.73|6.44||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||6.44|0.73|0.162
91532618|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09||||0.011|TWO_SIDED|95.0|1.38|12.17||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction\>=0.7%)||12.17|1.38|0.011
91753149|NCT04375397|183399136|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|80.0|-9.2|20.4|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at two-sided alpha = 0.2.||20.4|-9.2|=0.599
91753150|NCT04375397|183399136|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|95.0|-18.1|28.7|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at twosided alpha = 0.2.||28.7|-18.1|=0.599
91753151|NCT04375397|183399137|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.886|TWO_SIDED|95.0|0.13|10.44|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||10.44|0.13|=0.886
91753152|NCT04375397|183399137|SUPERIORITY||Odds Ratio (OR)|0.64|||=|0.705|TWO_SIDED|95.0|0.06|6.43|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -2~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||6.43|0.06|=0.705
91753153|NCT04375397|183399137|SUPERIORITY||Odds Ratio (OR)|0.0|||=|0.996|TWO_SIDED|95.0|0.0||The upper limit of this 95% CI is infinite.||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"|||0.00|=0.996
91753154|NCT04375397|183399137|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 0~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
91507921|NCT02566759|182888151|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.6662|||||TWO_SIDED|90.0|0.5969|0.7355||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.7355|0.5969|
91507922|NCT02566759|182888151|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.7795|||||TWO_SIDED|90.0|0.6597|0.8993|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.8993|0.6597|
91532619|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.31||||0.003|TWO_SIDED|95.0|1.79|15.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction\>=0.7%)||15.73|1.79|0.003
91753155|NCT04375397|183399137|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
91507923|NCT02566759|182888151|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Ratio|0.362|||||TWO_SIDED|90.0|0.3043|0.4301||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.||0.4301|0.3043|
91532620|NCT00495469|182942058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.264|TWO_SIDED|95.0|0.63|5.49||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction\>=0.7%)||5.49|0.63|0.264
91532621|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.48|TWO_SIDED|95.0|0.46|5.28||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7 mmol/L)||5.28|0.46|0.480
91532622|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.011|TWO_SIDED|95.0|1.44|16.46||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7 mmol/L)||16.46|1.44|0.011
91753156|NCT04375397|183399137|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
91507924|NCT02566759|182888151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|1.799|||||TWO_SIDED|90.0|1.4625|2.2116||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.2116|1.4625|
91507925|NCT02566759|182888154|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.872|||||TWO_SIDED|90.0|0.8145|0.9296||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9296|0.8145|
91507926|NCT02566759|182888154|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.9135|||||TWO_SIDED|90.0|0.8062|1.0209|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||1.0209|0.8062|
91507927|NCT02566759|182888154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.5|||||TWO_SIDED|90.0|0.4324|0.5777||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.5777|0.4324|
91507928|NCT02566759|182888154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.563|||||TWO_SIDED|90.0|2.1|3.1275||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||3.1275|2.1000|
91507929|NCT02566759|182888155|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8505|||<|0.001|TWO_SIDED|90.0|0.7925|0.9084|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9084|0.7925|<0.001
91507930|NCT02566759|182888155|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8415|||<|0.001|TWO_SIDED|90.0|0.7618|0.9212|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.9212|0.7618|<0.001
91507931|NCT02566759|182888155|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.543|||||TWO_SIDED|90.0|0.4797|0.6149||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.6149|0.4797|
91532623|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.087|TWO_SIDED|95.0|0.85|9.96||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7 mmol/L)||9.96|0.85|0.087
91507932|NCT02566759|182888155|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.336|||||TWO_SIDED|90.0|1.9592|2.7854||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.7854|1.9592|
91507933|NCT01096784|182888157|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0642||95.0|||||CMH Row Mean Score Test|||||||0.0642
91507934|NCT05107128|182888175|SUPERIORITY||Difference in Least Square (LS) Means|-1.1|STANDARD_ERROR_OF_MEAN|0.81||0.1675|TWO_SIDED|95.0|-2.7|0.5||The p-value was obtained from Mixed Model for Repeated Measures (MMRM) model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.5|-2.7|0.1675
91532624|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.082|TWO_SIDED|95.0|0.87|9.78||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7 mmol/L)||9.78|0.87|0.082
91753157|NCT04375397|183399138|SUPERIORITY||Difference in Medians|-1.5|||=|0.801|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on supplemental oxygen was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.801
91753158|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
91753159|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
91753160|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
91753161|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
91753162|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
91753163|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
91753164|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
91753165|NCT04375397|183399139|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
91753166|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
91753167|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
91753168|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
91753169|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
91753170|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
91507935|NCT05107128|182888176|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.4872|TWO_SIDED|95.0|-2.4|1.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and UHDRS - Independence Scale at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||1.1|-2.4|0.4872
91507936|NCT05107128|182888177|SUPERIORITY||Difference in LS Means|-5.0|STANDARD_ERROR_OF_MEAN|6.04||0.4089|TWO_SIDED|95.0|-17.0|6.9||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||6.9|-17.0|0.4089
91753171|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
91753172|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
91753173|NCT04375397|183399140|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
91753174|NCT04375397|183399141|SUPERIORITY||||||=|0.851|||||||Log Rank|||For the analysis of mechanical ventilation-free survival, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.851
91753175|NCT04375397|183399142|SUPERIORITY||Difference in Medians|0.0|||=|0.745|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on mechanical ventilation were compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.745
91753176|NCT04375397|183399143|SUPERIORITY||Difference in Medians|-0.5|||=|0.977|TWO_SIDED||||||Van Elteren's test]||Ibrutinib 420 mg + SOC - Placebo + SOC|Median duration of hospitalization was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.977
91753177|NCT04375397|183399144|SUPERIORITY||||||=|0.969|||||||Log Rank|||For the analysis of time to discharge from hospital, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.969
91753178|NCT00086502|183399148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.73|<|0.001||95.0|-0.85|-0.54||"Model terms: treatment; baseline; prior antihyperglycemic~agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]"|ANCOVA|||||-0.54|-0.85|<0.001
91753179|NCT00086502|183399149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_DEVIATION|30.9|<|0.001||95.0|-24.3|-11.0||Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]|ANCOVA|||||-11.0|-24.3|<0.001
91507937|NCT05107128|182888178|SUPERIORITY||Difference in LS Means|0.7|STANDARD_ERROR_OF_MEAN|1.26||0.5766|TWO_SIDED|95.0|-1.78|3.19||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and a baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||3.19|-1.78|0.5766
91532625|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.024|TWO_SIDED|95.0|1.2|13.27||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7 mmol/L)||13.27|1.20|0.024
91753180|NCT01304329|183399150|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.05|STANDARD_DEVIATION|5.4|||TWO_SIDED|90.0|98.9|105.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|Considered characteristic is empa plus simvastatin divided by empa alone||105.29|98.90|
91753181|NCT01304329|183399151|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.26|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|80.06|128.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin~Considered characteristic is empa plus simvastatin divided by simvastatin alone"||128.07|80.06|
91753182|NCT01304329|183399151|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|104.87|STANDARD_DEVIATION|25.5|||TWO_SIDED|90.0|90.09|122.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||122.07|90.09|
91753183|NCT01304329|183399152|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|109.49|STANDARD_DEVIATION|21.1|||TWO_SIDED|90.0|96.91|123.69|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone||123.69|96.91|
91753184|NCT01304329|183399153|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.18|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|76.3|123.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||123.77|76.30|
91507938|NCT05107128|182888179|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.64||0.1777|TWO_SIDED|95.0|-2.13|0.39||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.39|-2.13|0.1777
91753185|NCT01304329|183399153|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.27|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|84.9|111.44|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||111.44|84.90|
91753186|NCT01304329|183399154|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.52|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|99.1|106.06|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone.||106.06|99.10|
91753187|NCT01304329|183399155|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.34|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|80.39|130.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||130.29|80.39|
91753188|NCT01304329|183399155|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|111.25|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|95.93|129.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||129.02|95.93|
91753189|NCT05545644|183399160|SUPERIORITY||Hedges g|0.48|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
91753190|NCT05545644|183399161|SUPERIORITY||Hedges g|0.37|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
91753191|NCT05545644|183399162|SUPERIORITY||Hedges g|0.04|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
91753192|NCT05545644|183399162|SUPERIORITY|Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).|Mean Difference (Final Values)|0.19|||||TWO_SIDED||||||||||Hedges g = .04; SE = .42|||
91753193|NCT05545644|183399163|SUPERIORITY||Hedges g|0.44|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
91753194|NCT01643876|183399168|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.5|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.||||<0.0001
91753195|NCT01643876|183399169|SUPERIORITY_OR_OTHER||Median Difference (Net)|-57.5|||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.||||<0.05
91753196|NCT01945775|183399170|SUPERIORITY||Hazard Ratio, log|0.542|||<|0.0001|TWO_SIDED|95.0|0.413|0.711|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.711|0.413|<0.0001
91753197|NCT01945775|183399171|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.93|8.83|||Cochran-Mantel-Haenszel|||p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.||8.83|2.93|<0.0001
91753198|NCT01945775|183399172|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.1693|TWO_SIDED|95.0|0.67|1.073|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||1.073|0.670|0.1693
91753199|NCT01945775|183399180|SUPERIORITY||Mean Difference (Final Values)|8.4|||<|0.0001|TWO_SIDED|95.0|4.6|12.3|||Mixed Models Analysis|||Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.||12.3|4.6|<0.0001
91753200|NCT01945775|183399181|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.257|0.549|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.549|0.257|<0.0001
91507939|NCT05107128|182888180|SUPERIORITY||Difference in LS Means|3.9|STANDARD_ERROR_OF_MEAN|1.76||0.0291|TWO_SIDED|95.0|0.4|7.3||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and Hi-DEF at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||7.3|0.4|0.0291
91507940|NCT05107128|182888181|SUPERIORITY||Difference in LS Means|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2923|TWO_SIDED|95.0|-0.3|0.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and CGI at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.1|-0.3|0.2923
91507941|NCT03761628|182888183|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|40.9|||||ONE_SIDED|95.0|23.3|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||23.3|
91507942|NCT03761628|182888184|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Proportion with reduction|72.7|||||TWO_SIDED|95.0|49.8|89.3||||||||89.3|49.8|
91507943|NCT03761628|182888186|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|12.5|||||TWO_SIDED|95.0|0.3|52.7||||||||52.7|0.3|
91532626|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.012|TWO_SIDED|95.0|1.41|16.66||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7 mmol/L)||16.66|1.41|0.012
91532627|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.27|TWO_SIDED|95.0|0.62|5.54||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7.8 mmol/L)||5.54|0.62|0.270
91753201|NCT01945775|183399182|SUPERIORITY||Hazard Ratio (HR)|0.392||||0.0053|TWO_SIDED|95.0|0.198|0.775|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).||0.775|0.198|0.0053
91753202|NCT02876328|183399183|SUPERIORITY||||||<|0.001||||||Each active group is compared to placebo using a 2-sided .0167 significance level.|Cochran-Mantel-Haenszel|Analyses are stratified by site.||Analysis applies to both adults and children.||||<.001
91753203|NCT02068118|183399190|SUPERIORITY||rate ratio|0.97|||=|0.8|TWO_SIDED|95.0|0.77|1.23|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.23|0.77|=0.80
91753204|NCT02068118|183399191|SUPERIORITY||rate ratio|0.82|||=|0.18|TWO_SIDED|95.0|0.62|1.1|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.10|0.62|=0.18
91507944|NCT03761628|182888186|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|45.9||||||||45.9|0|
91507945|NCT05459129|182888198|SUPERIORITY||Difference in pCR Rates|33.33|||||TWO_SIDED|95.0|-33.23|99.9||||||||99.90|-33.23|
91507946|NCT05459129|182888199|SUPERIORITY||Difference in pRR|33.33|||||TWO_SIDED|95.0|-21.05|87.72||||||||87.72|-21.05|
91507947|NCT05459129|182888200|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.11|3.91|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median EFS per arm or HR between the arms.|||3.91|0.11|
91532628|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.18||||0.043|TWO_SIDED|95.0|1.04|9.72||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7.8 mmol/L)||9.72|1.04|0.043
91532629|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.169|TWO_SIDED|95.0|0.72|6.53||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7.8 mmol/L)||6.53|0.72|0.169
91532630|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.042|TWO_SIDED|95.0|1.04|9.36||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7.8 mmol/L)||9.36|1.04|0.042
91532631|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0.02|TWO_SIDED|95.0|1.23|11.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7.8 mmol/L)||11.06|1.23|0.020
91532632|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.211|TWO_SIDED|95.0|0.67|6.24||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7.8 mmol/L)||6.24|0.67|0.211
91507948|NCT05459129|182888201|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.13|6.43|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of media RFS per arm or HR between the arms.|||6.43|0.13|
91507949|NCT05459129|182888203|SUPERIORITY||Difference in ORR|16.67|||||TWO_SIDED|95.0|-54.99|88.32||||||||88.32|-54.99|
91507950|NCT05459129|182888204|SUPERIORITY||Difference in Event Free Rate|16.67|||||TWO_SIDED|95.0|-31.42|64.75|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|3 Months Analysis||64.75|-31.42|
91532633|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.179|TWO_SIDED|95.0|0.61|13.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction \>=1.7 mmol/L)||13.75|0.61|0.179
91532634|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.93||||0.03|TWO_SIDED|95.0|1.17|20.87||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction \>=1.7 mmol/L)||20.87|1.17|0.030
91507951|NCT05459129|182888204|SUPERIORITY||Difference in Event Free Rate|0.0|||||TWO_SIDED|95.0|-53.34|53.34|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|6 Months Analysis||53.34|-53.34|
91753205|NCT02068118|183399192|SUPERIORITY||rate ratio|0.6|||=|0.02|TWO_SIDED|95.0|0.39|0.92|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||0.92|0.39|=0.02
91753206|NCT02068118|183399193|SUPERIORITY||||||=|0.68|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.68
91753207|NCT02068118|183399195|SUPERIORITY||||||=|0.85|||||||Log Rank|||Time to death from any cause compared using the log-rank test||||=0.85
91753208|NCT02068118|183399196|SUPERIORITY||rate ratio|0.97|||=|0.77|TWO_SIDED|95.0|0.78|1.21|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).||1.21|0.78|=0.77
91507952|NCT05459129|182888205|SUPERIORITY||Difference in Event Free Rate|-13.33|||||TWO_SIDED|95.0|-64.83|38.16|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|3 Months Analysis||38.16|-64.83|
91507953|NCT05459129|182888205|SUPERIORITY||Difference in Event Free Rate|6.67|||||TWO_SIDED|95.0|-50.49|63.82|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|6 Months Analysis||63.82|-50.49|
91507954|NCT04649151|182888230|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on geometric least squares means \[GLSM\]) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|1.078|||||TWO_SIDED|95.0|0.94|1.237|||||GMR of P203 vs P301|||1.237|0.940|
91507955|NCT04649151|182888231|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%. and a point estimator \>-5% (minimum threshold)|percentage difference|-0.2|||||TWO_SIDED|95.0|-2.1|1.9|||||SRR difference of P203 vs P301|||1.9|-2.1|
91532635|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99||||0.142|TWO_SIDED|95.0|0.69|12.86||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (reduction \>=1.7 mmol/L)||12.86|0.69|0.142
91507956|NCT04649151|182888232|NON_INFERIORITY|The lower bound of the 95% CI of noninferiority margin of 1.5. GMR point estimate \>=0.8 (minimum threshold).|GMR|5.071|||||TWO_SIDED|95.0|4.477|5.745|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.745|4.477|
91507957|NCT04649151|182888233|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%.|SRR Difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4|||||SRR difference of P203 BD-Day 29 vs P301 Day 57|||2.4|-0.8|
91507958|NCT04649151|182888234|SUPERIORITY|The superiority of GMC (based on GLSM\] was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>1|GMR|48.191|||||TWO_SIDED|95.0|43.765|53.065|||||GMR of P203 vs P301|||53.065|43.765|
91507959|NCT04649151|182888237|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on GLSM) was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|4.493|||||TWO_SIDED|95.0|3.972|5.083|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.083|3.972|
91507960|NCT04649151|182888240|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|60.3|||||TWO_SIDED|95.0|26.6|78.6|||VE|Vaccine efficacy (VE, percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||78.6|26.6|
91507961|NCT04649151|182888241|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|43.5|||||TWO_SIDED|95.0|-16.5|72.2|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||72.2|-16.5|
91507962|NCT04649151|182888242|OTHER||VE|100.0|||||TWO_SIDED|95.0|61.2||NA = not estimable (not reached).||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.||||61.2|
91532636|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21||||0.012|TWO_SIDED|95.0|1.49|25.83||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction \>=1.7 mmol/L)||25.83|1.49|0.012
91532637|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.01|||<|0.001|TWO_SIDED|95.0|3.14|54.0||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction \>=1.7 mmol/L)||54.00|3.14|<0.001
91753209|NCT02068118|183399197|SUPERIORITY||rate ratio|0.97|||=|0.83|TWO_SIDED|95.0|0.74|1.27|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths from cardiovascular cause that occurred during a hospitalization for cardiovascular cause with an overnight stay were counted as two events."||1.27|0.74|=0.83
91753210|NCT02068118|183399198|SUPERIORITY||rate ratio|0.84|||=|0.28|TWO_SIDED|95.0|0.62|1.15|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.15|0.62|=0.28
91507963|NCT04649151|182888243|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|89.9|||||TWO_SIDED|95.0|51.0|98.9|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||98.9|51.0|
91507964|NCT01103934|182888296|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
91507965|NCT01103934|182888297|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91507966|NCT01120210|182888312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.0595|TWO_SIDED|90.0|-0.016|0.564|||ANCOVA|one-sided p-value and one-sided alpha=0.05||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose.||0.564|-0.016|0.0595
91507967|NCT01120210|182888312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.0215|TWO_SIDED|90.0|0.064|0.595||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 15 ng/kg/min dose.||0.595|0.064|0.0215
91507968|NCT01120210|182888312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.0049|TWO_SIDED|90.0|0.214|0.921||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 30 ng/kg/min dose.||0.921|0.214|0.0049
91507969|NCT01120210|182888313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.4729|TWO_SIDED|90.0|-2.312|2.131||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 5 ng/kg/min dose.||2.131|-2.312|0.4729
91507970|NCT01120210|182888313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.2123|TWO_SIDED|90.0|-4.164|1.464||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 15 ng/kg/min dose.||1.464|-4.164|0.2123
91507971|NCT01120210|182888313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.0821|TWO_SIDED|90.0|-5.639|0.483||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 30 ng/kg/min dose.||0.483|-5.639|0.0821
91507972|NCT01120210|182888314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7682|TWO_SIDED|95.0|-2.527|1.879||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 5 ng/kg/min dose.||1.879|-2.527|0.7682
91507973|NCT01120210|182888314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.4107|TWO_SIDED|95.0|-1.764|4.235||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 15 ng/kg/min dose.||4.235|-1.764|0.4107
91532638|NCT00495469|182942059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6||||0.01|TWO_SIDED|95.0|1.56|27.99||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction \>=1.7 mmol/L)||27.99|1.56|0.010
91507974|NCT01120210|182888314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.1811|TWO_SIDED|95.0|-1.046|5.372||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 30 ng/kg/min dose.||5.372|-1.046|0.1811
91753211|NCT02068118|183399199|SUPERIORITY||rate ratio|0.71|||=|0.078|TWO_SIDED|95.0|0.48|1.04|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.04|0.48|=0.078
91753212|NCT02068118|183399200|SUPERIORITY||rate ratio|0.5|||=|0.023|TWO_SIDED|95.0|0.28|0.91|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||0.91|0.28|=0.023
91753213|NCT02068118|183399201|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.044|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.99|0.62|=0.044
91753214|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|1.06|||=|0.17|TWO_SIDED|95.0|-2.48|4.61||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with physical functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.61|-2.48|=0.17
91753215|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|1.8|||=|0.23|TWO_SIDED|95.0|-2.61|6.21||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Physical score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role physical score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||6.21|-2.61|=0.23
91753216|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|4.46|||=|0.5|TWO_SIDED|95.0|0.59|8.33||Study group effect over time|Mixed Models Analysis|||ANCOVA Bodily Pain score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with bodily pain score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||8.33|0.59|=0.50
91753217|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|2.52|||=|0.19|TWO_SIDED|95.0|-0.07|5.12||Study group effect over time|Mixed Models Analysis|||ANCOVA General Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with general health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||5.12|-0.07|=0.19
91507975|NCT01120210|182888315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.803|TWO_SIDED|95.0|-6.06|4.718||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 5 ng/kg/min dose.||4.718|-6.060|0.8030
91507976|NCT01120210|182888315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.4923|TWO_SIDED|95.0|-7.781|3.801||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 15 ng/kg/min dose.||3.801|-7.781|0.4923
91507977|NCT01120210|182888315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.3152|TWO_SIDED|95.0|-11.251|3.708||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 30 ng/kg/min dose.||3.708|-11.251|0.3152
91507978|NCT01120210|182888316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.1561||95.0|-8.047|1.331||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 5 ng/kg/min dose.||1.331|-8.047|0.1561
91507979|NCT01120210|182888316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0282|TWO_SIDED|95.0|-10.482|-0.622||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 15 ng/kg/min dose.||-0.622|-10.482|0.0282
91507980|NCT01120210|182888316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.08||||0.0043|TWO_SIDED|95.0|-11.818|-2.332||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 30 ng/kg/min dose.||-2.332|-11.818|0.0043
91507981|NCT01120210|182888317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.9769|TWO_SIDED|95.0|-16.347|16.823||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min dose.||16.823|-16.347|0.9769
91507982|NCT01120210|182888318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98||||0.8297|TWO_SIDED|95.0|-16.592|20.551||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEDV at the end of the 30 ng/kg/min dose.||20.551|-16.592|0.8297
91532639|NCT00495469|182942060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.318|TWO_SIDED|95.0|-0.19|0.59||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.59|-0.19|0.318
91507983|NCT01120210|182888319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.865|TWO_SIDED|95.0|-3.352|3.968||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEF at the end of the 30 ng/kg/min dose.||3.968|-3.352|0.8650
91532640|NCT00495469|182942060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.131|TWO_SIDED|95.0|-0.73|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.73|0.131
91507984|NCT01120210|182888320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.3748|TWO_SIDED|95.0|-1.204|3.102||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in FS at the end of the 30 ng/kg/min dose.||3.102|-1.204|0.3748
91507985|NCT01120210|182888321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08||||0.2123|TWO_SIDED|95.0|-4.198|18.359||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 5 ng/kg/min dose.||18.359|-4.198|0.2123
91507986|NCT01120210|182888321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.78||||0.1083|TWO_SIDED|95.0|-2.016|19.575||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||19.575|-2.016|0.1083
91532641|NCT00495469|182942060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.452|TWO_SIDED|95.0|-0.54|0.24||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.24|-0.54|0.452
91532642|NCT00495469|182942060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.845|TWO_SIDED|95.0|-0.44|0.36||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.36|-0.44|0.845
91532643|NCT00495469|182942060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.393|TWO_SIDED|95.0|-0.58|0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.23|-0.58|0.393
91532644|NCT00495469|182942060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.072|TWO_SIDED|95.0|-0.76|0.03||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.03|-0.76|0.072
91753218|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|2.38|||=|0.034|TWO_SIDED|95.0|-0.09|4.85||Study group effect over time|Mixed Models Analysis|||ANCOVA Vitality score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with vitality score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.85|-0.09|=0.034
91753219|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|4.03|||=|0.025|TWO_SIDED|95.0|0.6|7.47||Study group effect over time|Mixed Models Analysis|||ANCOVA Social Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with social functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||7.47|0.60|=0.025
91532645|NCT00495469|182942061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.767|TWO_SIDED|95.0|-0.4|0.3||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.30|-0.40|0.767
91507987|NCT01120210|182888321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.16||||0.018|TWO_SIDED|95.0|2.557|25.771||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 30 ng/kg/min dose.||25.771|2.557|0.0180
91532646|NCT00495469|182942061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.604|TWO_SIDED|95.0|-0.46|0.27||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.27|-0.46|0.604
91532647|NCT00495469|182942061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.483|TWO_SIDED|95.0|-0.23|0.48||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.48|-0.23|0.483
91532648|NCT00495469|182942061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.956|TWO_SIDED|95.0|-0.35|0.37||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.37|-0.35|0.956
91532649|NCT00495469|182942061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.185|TWO_SIDED|95.0|-0.12|0.6||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.60|-0.12|0.185
91532650|NCT00495469|182942061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.863|TWO_SIDED|95.0|-0.32|0.39||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.39|-0.32|0.863
91532651|NCT00495469|182942062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.348|TWO_SIDED|95.0|-0.46|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|-0.46|0.348
91532652|NCT00495469|182942062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.952|TWO_SIDED|95.0|-0.33|0.31||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.31|-0.33|0.952
91532653|NCT00495469|182942062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.523|TWO_SIDED|95.0|-0.21|0.42||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.42|-0.21|0.523
91532654|NCT00495469|182942062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.889|TWO_SIDED|95.0|-0.34|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.34|0.889
91532655|NCT00495469|182942062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.124|TWO_SIDED|95.0|-0.07|0.56||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.56|-0.07|0.124
91532656|NCT00495469|182942062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.581|TWO_SIDED|95.0|-0.22|0.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.40|-0.22|0.581
91507988|NCT01120210|182888322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.4841|TWO_SIDED|95.0|-5.308|2.554||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 5 ng/kg/min dose.||2.554|-5.308|0.4841
91753220|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|1.01|||=|0.9|TWO_SIDED|95.0|-2.79|4.81||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Emotional score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role emotional score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.81|-2.79|=0.90
91753221|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|2.26|||=|0.19|TWO_SIDED|95.0|0.16|4.37||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with mental health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.37|0.16|=0.19
91753222|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|0.9|||=|0.26|TWO_SIDED|95.0|-0.48|2.28||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Component Summary (PCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with PCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.28|-0.48|=0.26
91753223|NCT02068118|183399202|SUPERIORITY||Adjusted Means Difference|1.2|||=|0.17|TWO_SIDED|95.0|0.08|2.31||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Component Summary (MCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with MCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.31|0.08|=0.17
91753224|NCT02068118|183399207|SUPERIORITY||||||=|0.03|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.03
91753225|NCT02068118|183399208|SUPERIORITY||||||=|0.15|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.15
91753226|NCT02068118|183399209|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.02|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.95|0.53|=0.02
91753227|NCT02068118|183399210|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.043|TWO_SIDED|95.0|0.39|0.98|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.98|0.39|=0.043
91753228|NCT00353873|183399216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|7.6|STANDARD_ERROR_OF_MEAN|3.01||0.012|TWO_SIDED|95.0|1.7|13.5|||ANCOVA|||||13.5|1.7|0.012
91753229|NCT00353873|183399217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.08||0.003|TWO_SIDED|95.0|3.2|15.3|||ANCOVA|||||15.3|3.2|0.003
91753230|NCT00353873|183399218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.389|TWO_SIDED|95.0|0.7|2.4|||Regression, Logistic|||||2.4|0.7|0.389
91753231|NCT00353873|183399219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.535|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||||1.9|0.7|0.535
91753232|NCT03743064|183399230|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.284|STANDARD_ERROR_OF_MEAN|0.289|<|0.0001|TWO_SIDED|95.0|0.718|1.851|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MWp H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.851|0.718|<0.0001
91753233|NCT03743064|183399231|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.399||0.7241|TWO_SIDED|95.0|-0.641|0.923|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant. The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||0.923|-0.641|0.7241
91753234|NCT03743064|183399232|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.081|STANDARD_ERROR_OF_MEAN|0.579||0.0003|TWO_SIDED|95.0|0.946|3.216|||ANOVA|||||3.216|0.946|0.0003
91532657|NCT00495469|182942063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.518|TWO_SIDED|95.0|-0.05|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.05|0.518
91507989|NCT01120210|182888322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.6665|TWO_SIDED|95.0|-5.567|3.594||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||3.594|-5.567|0.6665
91753235|NCT03743064|183399233|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|1.471|3.337|||ANOVA|||||3.337|1.471|<0.0001
91753236|NCT03743064|183399234|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.431||0.1443|TWO_SIDED|95.0|-0.215|1.472|||ANOVA|||||1.472|-0.215|0.1443
91753237|NCT03743064|183399235|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.452||0.7376|TWO_SIDED|95.0|-0.734|1.036|||ANOVA|||||1.036|-0.734|0.7376
91753238|NCT00870194|183399249|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority Margin of 0.4%||||||0.012||95.0|||||Mixed Model Repeated Measures|||||||.012
91753239|NCT00870194|183399249|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.4%|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.012|TWO_SIDED|95.0|0.07|0.53|||Mixed Model Repeated Measures||Standard Error of the Least Square Mean|Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.||0.53|0.07|.012
91753240|NCT00870194|183399250|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher's Exact Test|||||||.038
91753241|NCT00870194|183399251|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher's Exact Test|||||||.027
91753242|NCT00870194|183399252|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher's Exact Test|||||||.480
91753243|NCT00870194|183399253|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||.038
91753244|NCT00870194|183399254|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Mixed Model Repeated Measures|||||||.266
91753245|NCT00870194|183399255|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Mixed Model Repeated Measures|||||||.095
91753246|NCT00870194|183399256|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Model Repeated Measures|||||||.567
91507990|NCT01120210|182888322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6904|TWO_SIDED|95.0|-4.107|6.148||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 30 ng/kg/min dose.||6.148|-4.107|0.6904
91507991|NCT01120210|182888323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.6304|TWO_SIDED|95.0|-2.197|3.588||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 5 ng/kg/min dose.||3.588|-2.197|0.6304
91507992|NCT01120210|182888323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.842|TWO_SIDED|95.0|-3.851|3.153||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 15 ng/kg/min dose.||3.153|-3.851|0.8420
91507993|NCT01120210|182888323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.6658|TWO_SIDED|95.0|-4.138|2.669||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 30 ng/kg/min dose.||2.669|-4.138|0.6658
91507994|NCT01120210|182888324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-264.36||||0.051|TWO_SIDED|95.0|-529.875|1.147||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 5 ng/kg/min dose.||1.147|-529.875|0.0510
91507995|NCT01120210|182888324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-383.32||||0.0006|TWO_SIDED|95.0|-592.781|-173.867||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 15 ng/kg/min dose.||-173.867|-592.781|0.0006
91507996|NCT01120210|182888324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-527.77||||0.0001|TWO_SIDED|95.0|-764.07|-291.478||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 30 ng/kg/min dose.||-291.478|-764.070|0.0001
91532658|NCT00495469|182942063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.352|TWO_SIDED|95.0|-0.04|0.11||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.11|-0.04|0.352
91753247|NCT00870194|183399257|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Mixed Model Repeated Measures|||||||.207
91753248|NCT00870194|183399258|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||||||.055
91753249|NCT00870194|183399259|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANCOVA|||||||.269
91753250|NCT00870194|183399260|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||ANCOVA|||||||.622
91753251|NCT00870194|183399261|SUPERIORITY_OR_OTHER|||||||0.888||95.0|||||ANCOVA|||||||.888
91753252|NCT00870194|183399262|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Fisher's Exact Test|||||||.287
91753253|NCT00870194|183399263|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Fisher's Exact Test|||||||.498
91753254|NCT00870194|183399264|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Fisher's Exact Test|||||||.247
91753255|NCT00870194|183399265|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher's Exact Test|||||||1.00
91753256|NCT01831817|183399371|SUPERIORITY_OR_OTHER||Mean change difference|-0.1||||0.4321|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference was First named treatment-second named treatment that a negative difference implied the mean of the second named treatment was larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.15|-0.35|0.4321
91753257|NCT01831817|183399371|SUPERIORITY_OR_OTHER||Mean change difference|-0.48||||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.23|-0.73|0.0002
91507997|NCT04296396|182888325|NON_INFERIORITY|A non-inferiority design assumed a noninferiority margin of 5%. For 90% power and 0.025 significance level 1-sided, a total sample size of 4,300 participants was required to state that the IOPP is not inferior to the fixed amount of 20 tablets. Given the short window to assess pain at 1-week post-discharge, a 20% missing rate was incorporated which gives a final sample size of 5,500 (2,750 per group).|Risk Difference (RD)|0.67|||||TWO_SIDED|95.0|-2.03|3.37|||||The risk difference is the rate in the fixed group minus the rate in the IOPP group. IOPP was to be determined as non-inferior if the lower 95% confidence limit for the risk difference is -5 percentage points or greater (i.e., closer to zero).|||3.37|-2.03|
91507998|NCT04296396|182888326|SUPERIORITY||Risk Ratio (RR)|1.22||||0.046|TWO_SIDED|96.25|0.99|1.51|||Chi-squared||Confidence interval is 96.25% due to false discovery rate adjustment|||1.51|0.99|0.046
91507999|NCT04296396|182888327|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91508000|NCT04296396|182888328|SUPERIORITY||Median Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-6.6|-3.5|||quantile regression||Confidence interval is 97.5% due to false discovery rate adjustment|||-3.5|-6.6|<0.001
91508001|NCT04296396|182888329|SUPERIORITY||Median Difference (Net)|-15.0|||<|0.001|TWO_SIDED|98.75|-19.2|-10.8|||quartile regression||Confidence interval is 98.75% due to false discovery rate adjustment|||-10.8|-19.2|<0.001
91508002|NCT04296396|182888330|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|0.0|0.0|||quantile regression|||||0|0|1.0
91508003|NCT04296396|182888331|SUPERIORITY||Risk Ratio (RR)|0.96||||0.52|TWO_SIDED|95.0|0.85|1.09|||Chi-squared|||||1.09|0.85|0.52
91508004|NCT04296396|182888332|SUPERIORITY||Risk Ratio (RR)|0.99||||0.15|TWO_SIDED|95.0|0.98|1.0|||Regression, Linear|||||1.00|0.98|0.15
91508005|NCT05320029|182888339|NON_INFERIORITY|If the two-side 95%CI limit of the difference between the two groups is greater than the non-inferiority margin of -10%, the non-inferiority hypothesis of this study is valid|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.0458|0.0458|||Newcombe-Wilson|||||0.0458|-0.0458|<0.05
91508006|NCT02388997|182888393|SUPERIORITY|||||||0.59|||||||2-sample t-test with unequal variences|||||||0.59
91532659|NCT00495469|182942063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|0.01|0.026
91508007|NCT02388997|182888394|SUPERIORITY|||||||0.58|||||||2-sample t-test with unequal variances|||||||0.58
91508008|NCT02388997|182888395|SUPERIORITY|||||||0.87|||||||2-sample t-test with unequal variances|||||||0.87
91508009|NCT02388997|182888396|SUPERIORITY|||||||0.55|||||||2-sample t-test with unequal variances|||||||0.55
91508010|NCT02388997|182888397|SUPERIORITY|||||||0.6|||||||2-sample t-test with unequal variances|||||||0.6
91508011|NCT02388997|182888399|SUPERIORITY|||||||0.037||||||The p value is based on the fold change (ratio) of the geometric means of the time (days) to peak symptoms among asthmatics in the omalizumab/placebo treatment groups.|2-sample t-test on the log scale|||||||0.037
91508012|NCT00384813|182888403|SUPERIORITY_OR_OTHER||regression coefficient|0.33||||0.23||||||For both baseline to 4 month analyses (see above p value) and baseline to 10 month analyses, the variable of intervention group did not contribute significant additional variance.|Regression, Linear|||||||0.23
91508013|NCT03925727|182888440|SUPERIORITY||Mean Difference (Net)|1.4||||0.5533|TWO_SIDED|95.0|-3.2|6.0|||ANCOVA|||||6|-3.2|0.5533
91508014|NCT03925727|182888441|SUPERIORITY||Mean Difference (Net)|-0.6||||0.0192|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.0192
91508015|NCT02321462|182888450|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence intervals (CI) of the difference was higher than the predefined noninferiority margin (-15%).|Adjusted difference|-0.46|||||TWO_SIDED|95.0|-4.22|3.29|||||To investigate noninferiority of Eziclen compared to Fortrans®, the adjusted difference between these 2 groups was calculated with 95% CI of the adjusted difference.|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status (No IBD, IBD) was used.||3.29|-4.22|
91508016|NCT02321462|182888451|SUPERIORITY||Adjusted difference|0.15|||=|0.0249|TWO_SIDED|95.0|0.02|0.28|||ANOVA|A 2-way analysis of variance model (ANOVA) with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score.||0.28|0.02|=0.0249
91532660|NCT00495469|182942063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.069|TWO_SIDED|95.0|-0.01|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.01|0.069
91532661|NCT00495469|182942063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.154|TWO_SIDED|95.0|-0.02|0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.13|-0.02|0.154
91508017|NCT02321462|182888451|SUPERIORITY||Adjusted difference|0.11|||=|0.0382|TWO_SIDED|95.0|0.01|0.22|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score.||0.22|0.01|=0.0382
91508018|NCT02321462|182888451|SUPERIORITY||Adjusted difference|0.06|||=|0.2538|TWO_SIDED|95.0|-0.04|0.16|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Left Colon BBPS Score.||0.16|-0.04|=0.2538
91508019|NCT02321462|182888451|SUPERIORITY||Adjusted difference|0.33|||=|0.0256|TWO_SIDED|95.0|0.04|0.62|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Global BBPS Score.||0.62|0.04|=0.0256
91532662|NCT00495469|182942063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.005|TWO_SIDED|95.0|0.03|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|0.03|0.005
91508020|NCT02321462|182888452|SUPERIORITY||Adjusted difference|0.11|||=|0.084|TWO_SIDED|95.0|-0.02|0.24|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score (per protocol population).||0.24|-0.02|=0.0840
91508021|NCT02321462|182888452|SUPERIORITY||Treatment difference|0.08|||=|0.132|TWO_SIDED|95.0|-0.02|0.18|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score (per protocol population).||0.18|-0.02|=0.1320
91508022|NCT02321462|182888453|SUPERIORITY||Adjusted difference|-6.94|||=|0.2199|TWO_SIDED|95.0|-17.53|3.64|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of polyps.||3.64|-17.53|=0.2199
91508023|NCT02321462|182888453|SUPERIORITY||Adjusted difference|1.87|||=|0.6325|TWO_SIDED|95.0|-6.25|9.99|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of adenomas.||9.99|-6.25|=0.6325
91508024|NCT02321462|182888453|SUPERIORITY||Adjusted difference|-1.55|||=|0.7086|TWO_SIDED|95.0|-9.64|6.54|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of other lesions.||6.54|-9.64|=0.7086
91508025|NCT02321462|182888454|SUPERIORITY||Adjusted difference|0.01|||=|0.9927|TWO_SIDED|95.0|-3.12|3.14|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||3.14|-3.12|=0.9927
91508026|NCT02321462|182888455|SUPERIORITY||Adjusted difference|-0.3|||=|0.7039|TWO_SIDED|95.0|-1.88|1.27|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||1.27|-1.88|=0.7039
91508027|NCT02321462|182888456|SUPERIORITY||Adjusted difference|0.1|||=|0.1891|TWO_SIDED|95.0|-0.05|0.25|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||0.25|-0.05|=0.1891
91508028|NCT02321462|182888457|SUPERIORITY||Adjusted difference|13.35|||=|0.0011|TWO_SIDED|95.0|6.37|20.32|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||20.32|6.37|=0.0011
91532663|NCT00495469|182942064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.143|TWO_SIDED|95.0|-0.58|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.58|0.143
91508029|NCT01153581|182888467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91508030|NCT02741115|182888484|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.377||0.092|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|ANCOVA fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation used.||It was estimated that a sample size of 198 participants per group would provide 90% power to detect a mean treatment group difference in change from baseline to Week 26 in maximal VO2 scores of 10% (ie, an improvement of 2.8 mL/kg/min in the udenafil group compared to 0 in the control group, assuming a Type I error of 0.05 and standard deviation of 7.235). A difference of 2.8, equivalent to a 10% increase from a baseline of 28 mL/kg/min, represents approximately 0.4 standard deviations.||||0.092
91508031|NCT02741115|182888485|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.024|TWO_SIDED|||||LS mean was the estimated treatment difference from the analytical model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2.||||||0.024
91508032|NCT02741115|182888486|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.591||0.591|TWO_SIDED||||||ANCOVA|||||||0.591
91508033|NCT02741115|182888487|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.094||0.169|TWO_SIDED||||||ANCOVA|||||||0.169
91508034|NCT02741115|182888488|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Median Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.308||0.012|TWO_SIDED|||||LS mean was the estimated treatment mean difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.012
91508035|NCT02741115|182888489|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|||||LS mean was the estimated treatment difference in the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.029
91508036|NCT02741115|182888490|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.321||0.011|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.011
91508037|NCT02741115|182888491|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.903||0.696|TWO_SIDED||||||ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline VO2. LOCF imputation.||||||0.696
91508038|NCT02741115|182888492|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.319||0.915|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.915
91508039|NCT02741115|182888493|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.363||0.891|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||LS mean differences between treatment groups were analyzed.||||0.891
91508040|NCT02741115|182888494|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.1||0.691|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline physical functioning (child reported)||||||0.691
91508041|NCT02741115|182888495|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.544||0.985|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline physical functioning (parent reported).||||||0.985
91508042|NCT02741115|182888496|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.039||0.273|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (child reported).||||||0.273
91508043|NCT02741115|182888497|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.327||0.966|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (parent reported).||||||0.966
91508044|NCT02741115|182888498|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.011||0.706|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (Treatment II).||||||0.706
91508045|NCT02741115|182888499|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.707||0.382|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (perceived physical appearance)||||||0.382
91508046|NCT02741115|182888500|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|1.611||0.236|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (treatment anxiety).||||||0.236
91508047|NCT02741115|182888501|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.622||0.543|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (cognitive problems).||||||0.543
91532664|NCT00495469|182942064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.495|TWO_SIDED|95.0|-0.46|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.46|0.495
91508048|NCT02741115|182888502|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.78||0.352|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (communication problems).||||||0.352
91508049|NCT02741115|182888503|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|5.684||0.533|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, child reported).||||||0.533
91508050|NCT02741115|182888504|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|4.057||0.654|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, parent reported).||||||0.654
91508051|NCT02741115|182888505|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.069||0.963|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, child reported)||||||0.963
91508052|NCT02741115|182888506|SUPERIORITY|LS mean differences between treatment group were analyzed.|Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|1.171||0.246|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, parent reported).||||||0.246
91508053|NCT03750903|182888525|OTHER|||||||0.05|||||||ANOVA|||||||0.05
91508054|NCT03548584|182888533|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-1.87|-8.77|0.0026
91508055|NCT03548584|182888534|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-0.07|-0.47|0.0078
91532665|NCT00495469|182942064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.261|TWO_SIDED|95.0|-0.52|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.52|0.261
91532666|NCT00495469|182942064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.446|TWO_SIDED|95.0|-0.46|0.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.20|-0.46|0.446
91753258|NCT01831817|183399371|SUPERIORITY_OR_OTHER||Mean change difference|-0.49||||0.0002|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.24|-0.74|0.0002
91508056|NCT03548584|182888535|SUPERIORITY||LS Mean Difference|-1.95||||0.004|TWO_SIDED|95.0|-3.28|-0.63||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Aggressive Behavior||-0.63|-3.28|0.0040
91508057|NCT03548584|182888535|SUPERIORITY||LS Mean Difference|-1.41||||0.0296|TWO_SIDED|95.0|-2.68|-0.14||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Physically Nonaggressive Behavior||-0.14|-2.68|0.0296
91508058|NCT03548584|182888535|SUPERIORITY||LS Mean Difference|-1.24||||0.0113|TWO_SIDED|95.0|-2.21|-0.28||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Verbally Agitated Behavior||-0.28|-2.21|0.0113
91508059|NCT03548584|182888535|SUPERIORITY||LS Mean Difference|-0.36||||0.1941|TWO_SIDED|95.0|-0.9|0.18||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Hiding and Hoarding||0.18|-0.90|0.1941
91508060|NCT03548584|182888536|SUPERIORITY||LS Mean Difference|0.85||||0.4242|TWO_SIDED|95.0|-1.24|2.93||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 2||2.93|-1.24|0.4242
91508061|NCT03548584|182888536|SUPERIORITY||LS Mean Difference|-1.14||||0.3665|TWO_SIDED|95.0|-3.63|1.34||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 4||1.34|-3.63|0.3665
91508062|NCT03548584|182888536|SUPERIORITY||LS Mean Difference|-2.32||||0.1065|TWO_SIDED|95.0|-5.15|0.5||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.50|-5.15|0.1065
91508063|NCT03548584|182888536|SUPERIORITY||LS Mean Difference|-5.08||||0.0011|TWO_SIDED|95.0|-8.12|-2.05||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-2.05|-8.12|0.0011
91508064|NCT03548584|182888536|SUPERIORITY||LS Mean Difference|-6.47|||<|0.0001|TWO_SIDED|95.0|-9.54|-3.4||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-3.40|-9.54|<.0001
91532667|NCT00495469|182942064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.783|TWO_SIDED|95.0|-0.29|0.38||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.38|-0.29|0.783
91532668|NCT00495469|182942064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.21||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.21|-0.46|0.454
91532669|NCT00495469|182942065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.363|TWO_SIDED|95.0|-0.59|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.59|0.363
91508065|NCT03548584|182888536|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-1.87|-8.77|0.0026
91508066|NCT03548584|182888537|SUPERIORITY||LS Mean Difference|0.05||||0.3048|TWO_SIDED|95.0|-0.05|0.16||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 2||0.16|-0.05|0.3048
91508067|NCT03548584|182888537|SUPERIORITY||LS Mean Difference|-0.03||||0.7058|TWO_SIDED|95.0|-0.17|0.12||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 4||0.12|-0.17|0.7058
91508068|NCT03548584|182888537|SUPERIORITY||LS Mean Difference|-0.06||||0.4516|TWO_SIDED|95.0|-0.23|0.1||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.10|-0.23|0.4516
91508069|NCT03548584|182888537|SUPERIORITY||LS Mean Difference|-0.27||||0.0052|TWO_SIDED|95.0|-0.46|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-0.08|-0.46|0.0052
91532670|NCT00495469|182942065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.111|TWO_SIDED|95.0|-0.76|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.76|0.111
91532671|NCT00495469|182942065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.08|TWO_SIDED|95.0|-0.77|0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.04|-0.77|0.080
91508070|NCT03548584|182888537|SUPERIORITY||LS Mean Difference|-0.27||||0.006|TWO_SIDED|95.0|-0.47|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-0.08|-0.47|0.0060
91508071|NCT03548584|182888537|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-0.07|-0.47|0.0078
91508072|NCT03548584|182888538|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1975|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||Week 2||0.26|-0.05|0.1975
91508073|NCT03548584|182888538|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0084|TWO_SIDED|95.0|-0.44|-0.06|||Cochran-Mantel-Haenszel|||Week 4||-0.06|-0.44|0.0084
91508074|NCT03548584|182888538|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0101|TWO_SIDED|95.0|-0.46|-0.06|||Cochran-Mantel-Haenszel|||Week 6||-0.06|-0.46|0.0101
91532672|NCT00495469|182942065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.267|TWO_SIDED|95.0|-0.64|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|-0.64|0.267
91532673|NCT00495469|182942065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.549|TWO_SIDED|95.0|-0.54|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.54|0.549
91532674|NCT00495469|182942065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.056|TWO_SIDED|95.0|-0.81|0.01||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.01|-0.81|0.056
91532675|NCT00495469|182942066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.396|TWO_SIDED|95.0|-1.65|0.66||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.66|-1.65|0.396
91532676|NCT00495469|182942066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.013|TWO_SIDED|95.0|-2.7|-0.33||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.33|-2.70|0.013
91532677|NCT00495469|182942066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44||||0.017|TWO_SIDED|95.0|-2.61|-0.26||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.26|-2.61|0.017
91532678|NCT00495469|182942066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.015|TWO_SIDED|95.0|-2.61|-0.28||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.28|-2.61|0.015
91508075|NCT03548584|182888538|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0008|TWO_SIDED|95.0|-0.59|-0.15|||Cochran-Mantel-Haenszel|||Week 8||-0.15|-0.59|0.0008
91508076|NCT03548584|182888538|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0023|TWO_SIDED|95.0|-0.55|-0.12|||Cochran-Mantel-Haenszel|||Week 10||-0.12|-0.55|0.0023
91508077|NCT03548584|182888538|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.007|TWO_SIDED|95.0|-0.57|-0.09|||Cochran-Mantel-Haenszel|||Week 12||-0.09|-0.57|0.0070
91508078|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.1||||0.729|TWO_SIDED|95.0|0.64|1.91|||Cochran-Mantel-Haenszel|||\>/= 20%: Week 2||1.91|0.64|0.7290
91508079|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.09||||0.6196|TWO_SIDED|95.0|0.78|1.52|||Cochran-Mantel-Haenszel|||\>/=20%: Week 4||1.52|0.78|0.6196
91508080|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.16||||0.2718|TWO_SIDED|95.0|0.88|1.53|||Cochran-Mantel-Haenszel|||\>/=20%: Week 6||1.53|0.88|0.2718
91508081|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.52||||0.0004|TWO_SIDED|95.0|1.19|1.93|||Cochran-Mantel-Haenszel|||\>/=20%: Week 8||1.93|1.19|0.0004
91508082|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.42||||0.0006|TWO_SIDED|95.0|1.15|1.76|||Cochran-Mantel-Haenszel|||\>/=20%: Week 10||1.76|1.15|0.0006
91532679|NCT00495469|182942066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.069|TWO_SIDED|95.0|-2.26|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-2.26|0.069
91508083|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.41||||0.0004|TWO_SIDED|95.0|1.15|1.72|||Cochran-Mantel-Haenszel|||\>/=20%: Week 12||1.72|1.15|0.0004
91532680|NCT00495469|182942066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.086|TWO_SIDED|95.0|-0.15|2.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||2.20|-0.15|0.086
91508084|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.22||||0.7211|TWO_SIDED|95.0|0.39|3.85|||Cochran-Mantel-Haenszel|||\>/=30%: Week 2||3.85|0.39|0.7211
91508085|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.11||||0.7606|TWO_SIDED|95.0|0.57|2.14|||Cochran-Mantel-Haenszel|||\>/=30%: Week 4||2.14|0.57|0.7606
91508086|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.12||||0.5902|TWO_SIDED|95.0|0.74|1.68|||Cochran-Mantel-Haenszel|||\>/=30%: Week 6||1.68|0.74|0.5902
91508087|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.7||||0.0054|TWO_SIDED|95.0|1.14|2.54|||Cochran-Mantel-Haenszel|||\>/=30%: Week 8||2.54|1.14|0.0054
91508088|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.59||||0.0066|TWO_SIDED|95.0|1.11|2.26|||Cochran-Mantel-Haenszel|||\>/=30%: Week 10||2.26|1.11|0.0066
91508089|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.62||||0.0017|TWO_SIDED|95.0|1.18|2.23|||Cochran-Mantel-Haenszel|||\>/=30%: Week 12||2.23|1.18|0.0017
91508090|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.11||||0.9074|TWO_SIDED|95.0|0.2|5.97|||Cochran-Mantel-Haenszel|||\>/=40%: Week 2||5.97|0.20|0.9074
91508091|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|0.98||||0.9625|TWO_SIDED|95.0|0.36|2.64|||Cochran-Mantel-Haenszel|||\>/=40%: Week 4||2.64|0.36|0.9625
91508092|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.26||||0.512|TWO_SIDED|95.0|0.63|2.53|||Cochran-Mantel-Haenszel|||\>/=40%: Week 6||2.53|0.63|0.5120
91508093|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.98||||0.0244|TWO_SIDED|95.0|1.03|3.79|||Cochran-Mantel-Haenszel|||\>/=40%: Week 8||3.79|1.03|0.0244
91508094|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.86||||0.0161|TWO_SIDED|95.0|1.08|3.18|||Cochran-Mantel-Haenszel|||\>/=40%: Week 10||3.18|1.08|0.0161
91508095|NCT03548584|182888539|SUPERIORITY||Ratio of Response Rate|1.62||||0.0347|TWO_SIDED|95.0|1.0|2.61|||Cochran-Mantel-Haenszel|||\>/=40%: Week 12||2.61|1.00|0.0347
91508096|NCT03548584|182888540|SUPERIORITY||Ratio of Response Rate|0.64||||0.1503|TWO_SIDED|95.0|0.35|1.16|||Cochran-Mantel-Haenszel|||Week 2||1.16|0.35|0.1503
91508097|NCT03548584|182888540|SUPERIORITY||Ratio of Response Rate|1.07||||0.7559|TWO_SIDED|95.0|0.69|1.67|||Cochran-Mantel-Haenszel|||Week 4||1.67|0.69|0.7559
91508098|NCT03548584|182888540|SUPERIORITY||Ratio of Response Rate|1.23||||0.2246|TWO_SIDED|95.0|0.88|1.72|||Cochran-Mantel-Haenszel|||Week 6||1.72|0.88|0.2246
91508099|NCT03548584|182888540|SUPERIORITY||Ratio of Response Rate|1.38||||0.0276|TWO_SIDED|95.0|1.02|1.87|||Cochran-Mantel-Haenszel|||Week 8||1.87|1.02|0.0276
91508100|NCT03548584|182888540|SUPERIORITY||Ratio of Response Rate|1.46||||0.0031|TWO_SIDED|95.0|1.12|1.89|||Cochran-Mantel-Haenszel|||Week 10||1.89|1.12|0.0031
91508101|NCT03548584|182888540|SUPERIORITY||Ratio of Response Rate|1.47||||0.0017|TWO_SIDED|95.0|1.14|1.89|||Cochran-Mantel-Haenszel|||Week 12||1.89|1.14|0.0017
91508102|NCT03548584|182888541|SUPERIORITY||Ratio of Response Rate|1.1||||0.8549|TWO_SIDED|95.0|0.4|3.03|||Cochran-Mantel-Haenszel|||Week 2||3.03|0.40|0.8549
91508103|NCT03548584|182888541|SUPERIORITY||Ratio of Response Rate|1.95||||0.0093|TWO_SIDED|95.0|1.14|3.32|||Cochran-Mantel-Haenszel|||Week 4||3.32|1.14|0.0093
91508104|NCT03548584|182888541|SUPERIORITY||Ratio of Response Rate|1.56||||0.0083|TWO_SIDED|95.0|1.1|2.22|||Cochran-Mantel-Haenszel|||Week 6||2.22|1.10|0.0083
91508105|NCT03548584|182888541|SUPERIORITY||Ratio of Response Rate|1.85|||<|0.0001|TWO_SIDED|95.0|1.32|2.58|||Cochran-Mantel-Haenszel|||Week 8||2.58|1.32|<.0001
91508106|NCT03548584|182888541|SUPERIORITY||Ratio of Response Rate|1.57||||0.0005|TWO_SIDED|95.0|1.18|2.09|||Cochran-Mantel-Haenszel|||Week 10||2.09|1.18|0.0005
91508107|NCT03548584|182888541|SUPERIORITY||Ratio of Response Rate|1.32||||0.016|TWO_SIDED|95.0|1.03|1.69|||Cochran-Mantel-Haenszel|||Week 12||1.69|1.03|0.0160
91508108|NCT02215070|182888554|OTHER|||||||0.12|||||||Chi-squared|||||||0.12
91508109|NCT02215070|182888556|OTHER|||||||0.006|||||||Log Rank|||||||0.006
91508110|NCT02215070|182888557|OTHER|||||||0.002|||||||Log Rank|||||||0.002
91508111|NCT02096835|182888566|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
91508112|NCT02096835|182888567|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
91508113|NCT02096835|182888568|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
91508114|NCT02096835|182888569|SUPERIORITY_OR_OTHER|||||||0.571|TWO_SIDED||||||Chi-squared|||||||0.571
91753259|NCT01831817|183399371|SUPERIORITY_OR_OTHER||Mean change difference|0.38||||0.0028|TWO_SIDED|95.0|0.13|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.63|0.13|0.0028
91508115|NCT04368429|182888571|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in percentage was greater than (\>) -10% for the serogroup A.|Difference in percentage|20.27|||||TWO_SIDED|95.0|11.38|28.75|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup A||28.75|11.38|
91508116|NCT04368429|182888571|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup C.|Difference in percentage|33.98|||||TWO_SIDED|95.0|26.2|41.5|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup C||41.50|26.20|
91532681|NCT02851511|182942073|SUPERIORITY|tDCS vs. sham superiority with cognitive training will be tested based on the 320 participants who are assigned to the two cognitive training arms. The effects of tDCS on changes in NIH Toolbox Fluid Cognition Composite Score (NIHTB FCC) from baseline to 3-month follow-up are estimated by linear regression models, with missing outcomes predicted by regression models that include demographic and baseline characteristics.|Slope|0.33|STANDARD_ERROR_OF_MEAN|0.63|<|0.05|TWO_SIDED|95.0|-0.91|1.56||Formal statistical inference of the tDCS effect was based on the inverse-normal combination of two p-values, one from the Phase I data (N=42) and the other from the Phase II data (N=292).|Regression, Linear|||"Null hypothesis: The combination of cognitive training (12 weeks) and active stimulation (over the dorsolateral prefrontal cortex) will not lead to beneficial changes on the NIH Toolbox Cognition Battery.~The study is designed to have at least 90% power to detect a difference of effect size 0.42 between cognitive training+tDCS and cognitive training+sham, using a normal inverse combination test at one-sided 0.025 level."||1.56|-0.91|<0.05
91532682|NCT00372567|182942124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.484|2.235|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||No hypothesis tested.||2.235|0.484|
91532683|NCT00372567|182942125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.818|||||TWO_SIDED|95.0|0.64|12.41|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||12.41|0.640|
91753260|NCT01831817|183399371|SUPERIORITY_OR_OTHER||Mean change difference|0.39||||0.0022|TWO_SIDED|95.0|0.14|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons||0.63|0.14|0.0022
91753261|NCT01831817|183399371|SUPERIORITY_OR_OTHER||Mean change difference|-0.01||||0.9606|TWO_SIDED|95.0|-0.25|0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.24|-0.25|0.9606
91753262|NCT01831817|183399372|SUPERIORITY_OR_OTHER||Mean change difference|0.04||||0.803|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.38|-0.30|0.8030
91753263|NCT01831817|183399372|SUPERIORITY_OR_OTHER||Mean change difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.48|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.48|-1.16|<0.0001
91532684|NCT00372567|182942127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.027|||||TWO_SIDED|95.0|0.505|2.088|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.088|0.505|
91753264|NCT01831817|183399372|SUPERIORITY_OR_OTHER||Mean change difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.53|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.53|-1.20|<0.0001
91753265|NCT01831817|183399372|SUPERIORITY_OR_OTHER||Mean change difference|0.86|||<|0.0001|TWO_SIDED|95.0|0.53|1.19|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.19|0.53|<0.0001
91753266|NCT01831817|183399372|SUPERIORITY_OR_OTHER||Mean change difference|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.23|0.58|<0.0001
91753267|NCT01831817|183399372|SUPERIORITY_OR_OTHER||Mean change difference|-0.04||||0.7872|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.28|-0.37|0.7872
91532685|NCT00372567|182942128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.308|||||TWO_SIDED|95.0|0.4|13.0|||Cochran-Mantel-Haenszel|Stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||13.0|0.4|
91532686|NCT00372567|182942131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.434|||||TWO_SIDED|95.0|1.057|11.15|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||11.15|1.057|
91753268|NCT01831817|183399373|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9642|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.9642
91753269|NCT01831817|183399373|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0016|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0016
91753270|NCT01831817|183399373|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.01|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0100
91753271|NCT01831817|183399373|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.002|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0020
91753272|NCT01831817|183399373|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0122|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0122
91753273|NCT01831817|183399373|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.7138|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.7138
91753274|NCT01831817|183399374|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9834|TWO_SIDED|95.0|-5.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|-5.00|0.9834
91753275|NCT01831817|183399374|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|5.0||||0.0001|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0001
91753276|NCT01831817|183399374|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|2.5||||0.0003|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0003
91753277|NCT01831817|183399374|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0|||<|0.0001|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|<0.0001
91753278|NCT01831817|183399374|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0||||0.0002|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|0.0002
91753279|NCT01831817|183399374|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.2894|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.2894
91753280|NCT01831817|183399375|SUPERIORITY_OR_OTHER||Mean change difference|-0.24||||0.5555|TWO_SIDED|95.0|-1.03|0.56|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.56|-1.03|0.5555
91753281|NCT01831817|183399375|SUPERIORITY_OR_OTHER||Mean change difference|-0.06||||0.8769|TWO_SIDED|95.0|-0.86|0.73|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.73|-0.86|0.8769
91753282|NCT01831817|183399375|SUPERIORITY_OR_OTHER||Mean change difference|-0.76||||0.0562|TWO_SIDED|95.0|-1.55|0.02|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.02|-1.55|0.0562
91753283|NCT01831817|183399375|SUPERIORITY_OR_OTHER||Mean change difference|-0.18||||0.6562|TWO_SIDED|95.0|-0.95|0.6|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.60|-0.95|0.6562
91753284|NCT01831817|183399375|SUPERIORITY_OR_OTHER||Mean change difference|0.53||||0.1788|TWO_SIDED|95.0|-0.24|1.3|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.30|-0.24|0.1788
91753285|NCT01831817|183399375|SUPERIORITY_OR_OTHER||Mean change difference|-0.7||||0.0734|TWO_SIDED|95.0|-1.47|0.07|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.07|-1.47|0.0734
91753286|NCT01831817|183399376|SUPERIORITY_OR_OTHER||Mean change difference|0.19||||0.6727|TWO_SIDED|95.0|-0.71|1.1|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.10|-0.71|0.6727
91753287|NCT01831817|183399376|SUPERIORITY_OR_OTHER||Mean change difference|-1.24||||0.0072|TWO_SIDED|95.0|-2.14|-0.34|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.34|-2.14|0.0072
91753288|NCT01831817|183399376|SUPERIORITY_OR_OTHER||Mean change difference|-1.27||||0.0056|TWO_SIDED|95.0|-2.16|-0.38|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.38|-2.16|0.0056
91508117|NCT04368429|182888571|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup Y.|Difference in percentage|34.22|||||TWO_SIDED|95.0|26.66|41.64|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup Y||41.64|26.66|
91508118|NCT04368429|182888571|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup W.|Difference in percentage|38.19|||||TWO_SIDED|95.0|28.93|46.53|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup W||46.53|28.93|
91508119|NCT03633396|182888596|OTHER||Least Squares (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.98||0.944|TWO_SIDED|95.0|-4.05|3.77|||Mixed-model Repeated Measures (MMRM)|MMRM including fixed effects of treatment, history of plaque psoriasis, visit, treatment by visit interaction, and Baseline PPPASI score as covariate.|Least-squares mean difference = Imsidolimab - Placebo|The change from Baseline in PPPASI at Week 16 was analyzed using a a general linear mixed model for repeated measures (MMRM). The model included fixed effects for treatment, history of plaque psoriasis (Yes/No), visit, treatment by visit interaction, and Baseline PPPASI score as covariate.||3.77|-4.05|0.944
91532687|NCT00372567|182942132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.379|||||TWO_SIDED|95.0|0.1|2.3|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.3|0.1|
91532688|NCT00372567|182942133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.318|||||TWO_SIDED|95.0|0.5|3.8|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||3.8|0.5|
91753289|NCT01831817|183399376|SUPERIORITY_OR_OTHER||Mean change diference|1.43||||0.0016|TWO_SIDED|95.0|0.56|2.31|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.31|0.56|0.0016
91753290|NCT01831817|183399376|SUPERIORITY_OR_OTHER||Mean change difference|1.46||||0.0011|TWO_SIDED|95.0|0.59|2.33|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.33|0.59|0.0011
91753291|NCT01831817|183399376|SUPERIORITY_OR_OTHER||Mean change difference|-0.03||||0.9413|TWO_SIDED|95.0|-0.9|0.84|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.84|-0.90|0.9413
91753292|NCT00958217|183399379|SUPERIORITY_OR_OTHER||2nd order effects of time (2 slope|33.0|||<|0.05|TWO_SIDED|95.0||||P-values based on likelihood ratio tests for the significance of the first and second order trajectory parameters. Primary tests compared curvilinear trajectories of the two treatment groups.|Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.||||<.05
91753293|NCT00958217|183399380|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|57.0|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|||||<.05
91753294|NCT00958217|183399381|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.43|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Model|A logit link was used in this model.|We gauged sampling error with 95% confidence bands.|Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.||||<.05
91508120|NCT03633396|182888598|OTHER||Odds Ratio (OR)|0.879|||||TWO_SIDED|95.0|0.288|2.686|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPASI score as covariates and using multiple imputation for missing data.|||2.686|0.288|
91508121|NCT03633396|182888599|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|0.5|13.9|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPIGA score as covariates and using multiple imputation for missing data.|||13.9|0.5|
91508122|NCT00023673|182888603|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Lung V20||||0.62
91532689|NCT03890120|182942158|SUPERIORITY||Difference in Percentages|-1.4||||0.4186|TWO_SIDED|95.0|-15.2|12.3|||Mantel Haenszel||The difference of cilofexor and placebo,95% confidence interval(CI),and P value(1-sided)were obtained by the stratum-adjusted Mantel-Haenszel (MH) method,with baseline ursodeoxycholic acid(UDCA)use and Ludwig fibrosis stage as stratification factors.|||12.3|-15.2|0.4186
91753295|NCT00958217|183399381|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.26|||<|0.05|TWO_SIDED||||||Linear Mixed Effects Model|A logit link was used in this model|We gauged sampling error with 95% confidence bands.|Second statistical analysis evaluates trajectories of heavy drinking (\<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.||||<.05
91753296|NCT00260065|183399391|SUPERIORITY_OR_OTHER||Percentage of Participants|33.0||||||95.0|24.2|43.5||||||||43.5|24.2|
91753297|NCT00260065|183399392|SUPERIORITY_OR_OTHER||Percentage of Participants|52.0||||||95.0|41.3|61.7||||||||61.7|41.3|
91753298|NCT02440789|183399401|OTHER|||||||0.56|||||||t-test, 2 sided|paired t-test||||||0.56
91753299|NCT02440789|183399403|OTHER|||||||0.11|||||||t-test, 2 sided|paired t-test||||||0.11
91753300|NCT02440789|183399405|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.||||||0.93
91753301|NCT02440789|183399407|OTHER|||||||0.041|||||||t-test, 2 sided|paired t-test||||||0.041
91753302|NCT02440789|183399410|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
91753303|NCT02440789|183399412|OTHER|||||||0.26|||||||t-test, 2 sided|paired t-test||||||0.26
91753304|NCT02440789|183399414|OTHER|||||||0.75|||||||t-test, 2 sided|paired t-test||||||0.75
91753305|NCT02440789|183399416|OTHER|||||||0.97|||||||t-test, 2 sided|paired t-test||||||0.97
91753306|NCT02440789|183399418|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
91753307|NCT02440789|183399420|OTHER|||||||0.47|||||||t-test, 2 sided|paired t-test||||||0.47
91532690|NCT03890120|182942163|SUPERIORITY||Difference in Least Squares Mean (LSM)|-4.0||||0.3884|TWO_SIDED|95.0|-28.0|21.0|||ANCOVA||The LSM,95% CI and P-value(1-sided) were obtained by an analysis of covariance(ANCOVA)model with change at Week 96 as dependent variable,baseline value of outcome measure,baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||21|-28|0.3884
91532691|NCT03890120|182942164|SUPERIORITY||Difference in LSM|-9.0||||0.039|TWO_SIDED|95.0|-20.0|1.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1|-20|0.0390
91753308|NCT02440789|183399422|OTHER|||||||0.72|||||||t-test, 2 sided|paired t-test||||||0.72
91753309|NCT02440789|183399424|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
91753310|NCT02440789|183399426|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
91753311|NCT02440789|183399428|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
91753312|NCT02440789|183399430|OTHER|||||||0.77|||||||t-test, 2 sided|paired t-test||||||0.77
91753313|NCT02440789|183399432|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test||||||0.93
91753314|NCT02440789|183399434|OTHER|||||||0.65|||||||t-test, 2 sided|paired t-test||||||0.65
91753315|NCT02440789|183399436|OTHER|||||||0.22|||||||t-test, 2 sided|paired t-test||||||0.22
91753316|NCT02440789|183399438|OTHER|||||||0.031|||||||t-test, 2 sided|paired t-test||||||0.031
91753317|NCT02440789|183399440|OTHER|||||||0.005|||||||t-test, 2 sided|paired t-test||||||0.005
91753318|NCT02440789|183399442|OTHER|||||||0.69|||||||t-test, 2 sided|paired t-test||||||0.69
91753319|NCT02440789|183399444|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
91753320|NCT01999218|183399446|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares Means|0.1|||||TWO_SIDED|95.0|-0.02|0.22|||||Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.|||0.22|-0.02|
91753321|NCT01999218|183399446|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||"Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.~Time was treated as a categorical variable."|||0.30|0.06|
91753322|NCT01999218|183399447|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|1.6|||||TWO_SIDED|95.0|-4.5|7.7||||||||7.7|-4.5|
91753323|NCT01999218|183399447|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|0.5|||||TWO_SIDED|95.0|-5.6|6.5||||||||6.5|-5.6|
91753324|NCT01999218|183399448|OTHER||Difference in % vs. Glimepiride|3.0|||||TWO_SIDED|95.0|-0.3|6.4||||||||6.4|-0.3|
91753325|NCT01999218|183399448|OTHER||Difference in % vs. Glimepiride|1.5|||||TWO_SIDED|95.0|-1.7|4.7||||||||4.7|-1.7|
91753326|NCT01999218|183399449|OTHER||Difference in % vs. Glimepiride|-14.0|||<|0.001|TWO_SIDED|95.0|-18.4|-9.8|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-9.8|-18.4|<0.001
91753327|NCT01999218|183399449|OTHER||Difference in % vs. Glimepiride|-16.1|||<|0.001|TWO_SIDED|95.0|-20.3|-12.2|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-12.2|-20.3|<0.001
91753328|NCT01999218|183399450|OTHER||Difference in LSM vs. Glimepiride|-4.29|||<|0.001|TWO_SIDED|95.0|-4.77|-3.8|||Constrained Longitudinal Data analysis||LSM=Least Squares Means||Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.80|-4.77|<0.001
91753329|NCT01999218|183399450|OTHER||Difference in the LSM vs. Glimepiride|-3.87|||<|0.001|TWO_SIDED|95.0|-4.36|-3.38|||Constrained Longitudinal Data Analysis||||Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.38|-4.36|<0.001
91753330|NCT01999218|183399451|OTHER||Difference in the LSM vs. Glimepiride|-4.77|||<|0.001|TWO_SIDED|95.0|-6.29|-3.25|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.25|-6.29|<0.001
91753331|NCT01999218|183399451|OTHER||Difference in the LSM vs. Glimepiride|-3.2|||<|0.001|TWO_SIDED|0.001|-4.73|-1.67|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-1.67|-4.73|<0.001
91753332|NCT01073930|183399458|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|9.8|||||ONE_SIDED|97.5|3.4||||||||||3.4|
91753333|NCT01073930|183399459|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|10.7|||||ONE_SIDED|97.5|4.9|||||||Ascending colon comparison|||4.9|
91753334|NCT01073930|183399459|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|6.6|||||ONE_SIDED|97.5|1.6|||||||Mid colon comparison|||1.6|
91508123|NCT00023673|182888603|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Lung V20||||0.22
91508124|NCT00023673|182888604|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Mean Lung Dose||||0.30
91508125|NCT00023673|182888604|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Lung Dose||||0.17
91508126|NCT00023673|182888604|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Esophageal Dose||||0.08
91508127|NCT00667342|182888630|OTHER|The association between response and Ktrans at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
91508128|NCT00667342|182888631|OTHER|The association between response and Vp at Week 10 was evaluated.||||||0.0573|||||||Logistic Regression|||||||0.0573
91508129|NCT00667342|182888632|OTHER|The association between response and Ve at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
91532692|NCT03890120|182942165|SUPERIORITY||Difference in LSM|-2.6||||0.2845|TWO_SIDED|95.0|-11.6|6.4|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||6.4|-11.6|0.2845
91753335|NCT01073930|183399459|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|5.2|||||ONE_SIDED|97.5|0.4|||||||Recto-sigmoid colon comparison|||0.4|
91508130|NCT00293384|182888652|SUPERIORITY_OR_OTHER||proportion|0.57||||0.1|TWO_SIDED|||||85% statistical power|Simon optimal design|||Optimal Simon design for phase II study. p0=45% p1=65%.||||0.10
91532693|NCT03890120|182942166|SUPERIORITY||Difference in Percentages|4.1||||0.1978|TWO_SIDED|95.0|-5.3|13.5|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||13.5|-5.3|0.1978
91508131|NCT00293384|182888653|SUPERIORITY_OR_OTHER||proportion|0.63||||||||||||||||||
91508132|NCT00293384|182888655|SUPERIORITY_OR_OTHER||proportion|0.06|||||TWO_SIDED|||||||||||||
91508133|NCT00326612|182888687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0||||||||||||
91508134|NCT00326612|182888688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.2|3.9||||||||3.9|0.2|
91508135|NCT00326612|182888689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.4|2.7||||||||2.7|0.4|
91508136|NCT00326612|182888690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.2|8.2||||||||8.2|0.2|
91508137|NCT00326612|182888691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.0|67.3||||||||67.3|0.0|
91508138|NCT00326612|182888692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|0.2|140.7||||||||140.7|0.2|
91508139|NCT01454934|182888706|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.1343|TWO_SIDED|95.0|0.95|1.41||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.41|0.95|0.1343
91508140|NCT01454934|182888707|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.3946|TWO_SIDED|95.0|0.9|1.32||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.32|0.90|0.3946
91508141|NCT01454934|182888708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3034||||||The P-value was stratified by histology, TPC option, and geographic region.|Cochran-Mantel-Haenszel|||OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||||0.3034
91508142|NCT01018264|182888727|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.2||||0.53|TWO_SIDED||||||ANCOVA|Adjusted for baseline value|This represents the effect size between solifenacin and placebo.|||||0.53
91508143|NCT01018264|182888728|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.53||||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
91508144|NCT01018264|182888729|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.35||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
91508145|NCT01018264|182888730|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.27||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
91508146|NCT01018264|182888731|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.11||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
91508147|NCT00792610|182888732|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|STANDARD_DEVIATION|0.05|<|0.05||95.0|0.05|0.15|||t-test, 2 sided|||Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.||.15|.05|<0.05
91508148|NCT03746522|182888733|OTHER|||||||0.0006||||||P-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||0.0006
91508149|NCT03746522|182888734|OTHER|||||||0.0005||||||p-value was one-sided and compared with alpha = 0.025|Rubin's Rule|||||||0.0005
91508150|NCT03746522|182888735|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha=0.025.|Rubin's Rule|||||||<0.0001
91753336|NCT01073930|183399459|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|11.4|||||ONE_SIDED|97.5|5.2|||||||Overall: Ascending, mid, and recto-sigmoid colon comparison|||5.2|
91753337|NCT01073930|183399460|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91508151|NCT03746522|182888736|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||<0.0001
91753338|NCT01073930|183399461|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91753339|NCT01073930|183399462|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91508152|NCT05422053|182888753|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of Control-IQ Use (13 Weeks) compared to Control-IQ Start||||<0.001
91753340|NCT01073930|183399463|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91753341|NCT01073930|183399464|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91753342|NCT01073930|183399465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91508153|NCT02659020|182888783|SUPERIORITY||Hazard Ratio (HR)|0.945||||0.775|TWO_SIDED|95.0|0.639|1.397||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.397|0.639|0.775
91508154|NCT02659020|182888793|SUPERIORITY||Hazard Ratio (HR)|0.667||||0.148|TWO_SIDED|95.0|0.385|1.158||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.158|0.385|0.148
91508155|NCT02659020|182888794|SUPERIORITY||Hazard Ratio (HR)|0.692||||0.055|TWO_SIDED|95.0|0.476|1.007||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.007|0.476|0.055
91508156|NCT02659020|182888794|SUPERIORITY||Hazard Ratio (HR)|0.828||||0.482|TWO_SIDED|95.0|0.49|1.398||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank|||||1.398|0.490|0.482
91532694|NCT03890120|182942167|SUPERIORITY||Difference in Percentages|8.9||||0.0797|TWO_SIDED|95.0|-3.5|21.2|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||21.2|-3.5|0.0797
91532695|NCT03890120|182942168|SUPERIORITY||Difference in LSM|1.0||||0.7275|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||3|-1|0.7275
91753343|NCT00541346|183399467|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|26.3|||<|0.001|TWO_SIDED|95.0|19.6|33.1||Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||33.1|19.6|<0.001
91753344|NCT00541346|183399468|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|23.1|||<|0.001|TWO_SIDED|95.0|16.9|29.3||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||29.3|16.9|<0.001
91753345|NCT00541346|183399469|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|10.9|||<|0.001|TWO_SIDED|95.0|5.4|16.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.||Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||16.8|5.4|<0.001
91753346|NCT00541346|183399470|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.2|||<|0.001|TWO_SIDED|95.0|3.3|11.1||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||11.1|3.3|<0.001
91753347|NCT00541346|183399471|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|4.1|||<|0.01||95.0|1.2|6.9||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.9|1.2|<0.01
91753348|NCT00541346|183399472|SUPERIORITY_OR_OTHER||Bayesian random intercept model.|3.5|||<|0.001|TWO_SIDED|95.0|1.8|5.2||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||5.2|1.8|<0.001
91753349|NCT00541346|183399473|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-10.9|||<|0.001|TWO_SIDED|95.0|-16.8|-5.4||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-5.4|-16.8|<0.001
91753350|NCT00541346|183399474|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|1.94|||>|0.21|TWO_SIDED|95.0|-2.98|6.82||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.82|-2.98|>0.21
91753351|NCT00541346|183399475|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-3.4|||>|0.06|TWO_SIDED|95.0|-7.9|0.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||0.80|-7.9|>0.06
91753352|NCT00541346|183399476|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-5.26|||<|0.01|TWO_SIDED|95.0|-9.37|-1.18||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-1.18|-9.37|<0.01
91753353|NCT00541346|183399477|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.6|||>|0.11|TWO_SIDED|95.0|-5.6|20.7||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||20.7|-5.6|>0.11
91753354|NCT05149313|183399519|SUPERIORITY||Difference in percentages|27.88|||<|0.0001|TWO_SIDED|95.0|15.63|40.14|||Cochran-Mantel-Haenszel|||||40.14|15.63|<0.0001
91753355|NCT05149313|183399520|SUPERIORITY||Difference in percentages|17.8||||0.0052|TWO_SIDED|95.0|7.03|28.57|||Cochran-Mantel-Haenszel|||||28.57|7.03|0.0052
91753356|NCT05149313|183399521|SUPERIORITY||Difference in percentages|18.15||||0.0114|TWO_SIDED|95.0|5.47|30.83|||Cochran-Mantel-Haenszel|||||30.83|5.47|0.0114
91753357|NCT04243330|183399538|SUPERIORITY||Mean Difference (Net)|1.01||||0.18|TWO_SIDED|95.0|-0.46|2.48||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.48|-0.46|0.18
91753358|NCT04243330|183399539|SUPERIORITY||Mean Difference (Net)|3.58||||0.06|TWO_SIDED|95.0|-0.11|7.28||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.28|-0.11|.06
91753359|NCT04243330|183399540|SUPERIORITY||Median Difference (Net)|1.7||||0.6|TWO_SIDED|95.0|-4.5|7.9||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.9|-4.5|0.60
91753360|NCT04243330|183399541|SUPERIORITY||Median Difference (Net)|-4.1||||0.36|TWO_SIDED|95.0|-12.8|4.7||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||4.7|-12.8|0.36
91753361|NCT04243330|183399542|SUPERIORITY||Mean Difference (Net)|-4.5||||0.02|TWO_SIDED|95.0|-8.3|-0.67||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||-0.67|-8.3|.02
91753362|NCT04243330|183399543|SUPERIORITY||Mean Difference (Net)|-0.56||||0.82|TWO_SIDED|95.0|-5.5|4.4|||Mixed Models Analysis|||||4.4|-5.5|0.82
91753363|NCT03826342|183399553|SUPERIORITY|||||||0.2964|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.2964
91753364|NCT03826342|183399553|SUPERIORITY|||||||0.3404|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.3404
91753365|NCT03826342|183399554|SUPERIORITY|||||||0.7915|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.7915
91753366|NCT03826342|183399554|SUPERIORITY|||||||0.2131|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.2131
91753367|NCT03826342|183399555|SUPERIORITY|||||||0.8357|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.8357
91753368|NCT03826342|183399555|SUPERIORITY|||||||0.095|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.0950
91753369|NCT03826342|183399556|SUPERIORITY|||||||0.7496|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.7496
91532696|NCT03890120|182942169|SUPERIORITY||Difference in LSM|-0.03||||0.3636|TWO_SIDED|95.0|-0.2|0.14|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||0.14|-0.20|0.3636
91753370|NCT03826342|183399557|SUPERIORITY|||||||0.4492|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.4492
91753371|NCT03826342|183399558|SUPERIORITY|||||||0.0765|||||||t-test, 2 sided|||||||0.0765
91753372|NCT03826342|183399559|SUPERIORITY|||||||0.535|||||||t-test, 2 sided|||||||0.535
91753373|NCT03826342|183399560|SUPERIORITY|||||||0.4302|||||||t-test, 2 sided|||||||0.4302
91753374|NCT03826342|183399561|SUPERIORITY|||||||0.807|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.8070
91753375|NCT01114360|183399623|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||ANOVA|Two-way repeated measures mixed model ANOVA.||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.075
91753376|NCT01114360|183399623|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||||||0.75
91753377|NCT01114360|183399624|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
91753378|NCT01114360|183399625|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
91753379|NCT01114360|183399626|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||ANOVA|||||||0.64
91753380|NCT01114360|183399627|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
91753381|NCT01114360|183399628|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
91753382|NCT01114360|183399629|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
91753383|NCT01114360|183399630|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.75
91532697|NCT03890120|182942170|SUPERIORITY||Difference in LSM|-0.3||||0.3595|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1.5|-2.2|0.3595
91753384|NCT01114360|183399631|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Friedman|||||||0.71
91753385|NCT01114360|183399632|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Friedman|||||||0.38
91753386|NCT01114360|183399633|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Friedman|||||||0.11
91753387|NCT01114360|183399634|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||||||0.96
91753388|NCT01114360|183399635|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
91753389|NCT01114360|183399636|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||ANOVA|||||||0.52
91753390|NCT03007745|183399639|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|3.08|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
91753391|NCT03007745|183399639|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_DEVIATION|3.97|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
91753392|NCT03007745|183399639|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.61||0.9171|TWO_SIDED|||||Adjusted mean changes and adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values|ANCOVA|||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9171
91753393|NCT03007745|183399639|NON_INFERIORITY|We hypothesized that the lower bound of the non-inferiority analysis of FOSQ-10 would be greater than the a-priori threshold of -1.0.|||||>|0.05||||||"Adjusted group difference in mean change in FOSQ-10 score from baseline to Month 3, controlling for baseline FOSQ and site, was -0.06 ± 061 (SEM) (P = 0.917).~The lower bound of the 95% noninferiority confidence interval was -1.08"|ANCOVA|||||||>0.05
91753394|NCT03007745|183399640|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_DEVIATION|4.86|<|0.0001|ONE_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
91753395|NCT03007745|183399640|SUPERIORITY||Mean Difference (Net)|-3.51|STANDARD_DEVIATION|5.52|<|0.0001|TWO_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
91753396|NCT03007745|183399640|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.9251|ONE_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9251
91753397|NCT03007745|183399641|SUPERIORITY|Paired t-test comparing change in score (3-month - baseline) within group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||0.4116|ONE_SIDED||||||t-test, 2 sided|Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||Within arm change from baseline to 3 month follow-up||||0.4116
91753398|NCT03007745|183399641|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||0.2201|ONE_SIDED||||||t-test, 2 sided|||Paired t-test comparing change in score (3-month - baseline) within group||||0.2201
91753399|NCT03007745|183399641|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1732|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes between groups from baseline to month 3 in participants initiated on CPAP (LOCF applied using 1-month data).||||0.1732
91753400|NCT03007745|183399642|SUPERIORITY||Mean Difference (Final Values)|-2.76|STANDARD_DEVIATION|4.73|<|0.0003|ONE_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0003
91753401|NCT03007745|183399642|SUPERIORITY||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|5.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
91753402|NCT03007745|183399642|SUPERIORITY||Median Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.9||0.673|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.6730
91753403|NCT03007745|183399643|SUPERIORITY||Mean Difference (Net)|-5.94|STANDARD_DEVIATION|6.17|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||||<0.0001
91753404|NCT03007745|183399643|SUPERIORITY|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)|Mean Difference (Final Values)|-5.6|STANDARD_DEVIATION|6.96||0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.0001
91753405|NCT03007745|183399643|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|1.11||0.9903|TWO_SIDED|||||ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure|ANCOVA|Adjusted differences in mean changes estimated as site-total-sample-size weighted values controlling for group differences in mean baseline values||Between group comparison of change in Insomnia Severity Index (ISI) at 3 months (LOCF applied using 1-month data)||||0.9903
91753406|NCT03007745|183399647|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Between group comparison of Client Satisfaction Questionnaire (CSQ-8) at 3 months (LOCF applied using 1-month data)||||>0.05
91753407|NCT03007745|183399648|NON_INFERIORITY|The a-priori lower bound selected for the non-inferiority analysis of average daily CPAP use over 3 months was -0.75 hours.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.37||0.308|TWO_SIDED|||||Group difference (REVAMP - In-person) in mean CPAP daily use over all days adjusted for investigative site.|ANCOVA|The lower bound of the 95% noninferiority confidence interval was -0.22.||||||0.308
91753408|NCT00765882|183399676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93||||0.0012|TWO_SIDED|95.0|1.5|5.72||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 90% based on study NCT00402337 (MCP-103-201) data."||5.72|1.50|0.0012
91753409|NCT00765882|183399676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.22|||<|0.0001|TWO_SIDED|95.0|2.2|8.1||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 96% based on study NCT00460811 (MCP-103-202) data."||8.10|2.20|<0.0001
91753410|NCT00168103|183399720|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.525||||0.0025|TWO_SIDED|95.0|-2.217|-0.033||1-sided P-value. The a priori threshold was 0.024 (overall Type 1 error 0.025 adjusted for alpha spending for an interim analysis).|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodges-Lehmann estimate.|||-0.033|-2.217|0.0025
91753411|NCT00168103|183399721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1088||||0.0014|TWO_SIDED|80.0|0.0392|0.3023||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Fisher Exact|1-sided|The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|Worsened intensity was evaluated between 2 and 4 hours after start of study treatment relative to baseline for at least 1 of the HAE symptoms present at baseline.||0.3023|0.0392|0.0014
91753412|NCT00168103|183399722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.292||||0.0237|TWO_SIDED|80.0|-5.15|-1.05||1-sided, exploratory test.|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodge-Lehmann estimate.|This was an exploratory analysis.||-1.050|-5.150|0.0237
91753413|NCT00168103|183399723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1714|||||TWO_SIDED|95.0|0.0642|0.4575|||||The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|This was an exploratory analysis.||0.4575|0.0642|
91753414|NCT00168103|183399724|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED|80.0||||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Wilcoxon (Mann-Whitney)|1-sided||||||0.0329
91753415|NCT05268744|183399740|SUPERIORITY|Since all outcomes were normally distributed, one-sided paired t-test was used to compare mean pre- and post-treatment scores to see whether post-treatment scores of ABI-S and SRS had improved compared to pre-treatment scores|||||<|0.05|||||||t-test, 1 sided|||Null hypothesis was no improvement in mean ABI-S and SRS scores at the end of the study, compared to baseline||||<0.05
91753416|NCT02699450|183399742|SUPERIORITY||Difference in Least Squares Means|1.4||||0.37|TWO_SIDED|80.0|-0.6|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-0.6|0.37
91753417|NCT02699450|183399742|SUPERIORITY||Difference in Least Squares Means|3.6||||0.03|TWO_SIDED|80.0|1.5|5.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.6|1.5|0.03
91753418|NCT02699450|183399743|SUPERIORITY||Difference in Least Squares Means|1.3||||0.63|TWO_SIDED|80.0|-2.3|5.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.0|-2.3|0.63
91753419|NCT02699450|183399744|SUPERIORITY||Difference in Least Squares Means|2.3||||0.15|TWO_SIDED|80.0|0.2|4.3||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.3|0.2|0.15
91759523|NCT02391363|183411774|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
91753420|NCT02699450|183399744|SUPERIORITY||Difference in Least Squares Means|2.9||||0.04|TWO_SIDED|80.0|1.1|4.7||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.7|1.1|0.04
91753421|NCT02699450|183399745|SUPERIORITY||Difference in Least Squares Means|0.8||||0.94|TWO_SIDED|80.0|-11.3|12.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||12.8|-11.3|0.94
91753422|NCT02699450|183399745|SUPERIORITY||Difference in Least Squares Means|7.3||||0.46|TWO_SIDED|80.0|-5.4|19.9||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.9|-5.4|0.46
91753423|NCT02699450|183399746|SUPERIORITY||Difference in Percentage of Participants|6.4||||0.56|TWO_SIDED|80.0|-7.7|20.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||20.5|-7.7|0.56
91753424|NCT02699450|183399747|SUPERIORITY||Difference in Least Squares Means|6.6||||0.43|TWO_SIDED|80.0|-4.0|17.2||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.2|-4.0|0.43
91753425|NCT02699450|183399747|SUPERIORITY||Difference in Least Squares Means|7.2||||0.34|TWO_SIDED|80.0|-2.6|17.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.0|-2.6|0.34
91753426|NCT02699450|183399748|SUPERIORITY||Difference in Least Squares Means|9.5||||0.27|TWO_SIDED|80.0|-1.6|20.6||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||20.6|-1.6|0.27
91753427|NCT02699450|183399748|SUPERIORITY||Difference in Least Squares Means|6.8||||0.45|TWO_SIDED|80.0|-4.9|18.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||18.5|-4.9|0.45
91753428|NCT02699450|183399749|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.96|TWO_SIDED|80.0|-16.8|15.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||15.5|-16.8|0.96
91753429|NCT02699450|183399750|SUPERIORITY||Difference in Least Squares Means|9.9||||0.19|TWO_SIDED|80.0|0.1|19.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.7|0.1|0.19
91753430|NCT02699450|183399750|SUPERIORITY||Difference in Least Squares Means|4.2||||0.57|TWO_SIDED|80.0|-5.3|13.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||13.6|-5.3|0.57
91753431|NCT02699450|183399751|SUPERIORITY||Difference in Least Squares Means|-2.8||||0.64|TWO_SIDED|80.0|-10.5|4.9||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.9|-10.5|0.64
91508157|NCT02659020|182888795|SUPERIORITY||Odds Ratio (OR)|1.589||||0.1891|TWO_SIDED|95.0|0.794|3.179||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||3.179|0.794|0.1891
91508158|NCT02659020|182888795|SUPERIORITY||Odds Ratio (OR)|2.668||||0.0642|TWO_SIDED|95.0|0.923|7.71||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||7.710|0.923|0.0642
91508159|NCT02659020|182888796|SUPERIORITY||Odds Ratio (OR)|1.106||||0.7724|TWO_SIDED|95.0|0.558|2.194||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.194|0.558|0.7724
91508160|NCT02659020|182888796|SUPERIORITY||Odds Ratio (OR)|1.222||||0.6508|TWO_SIDED|95.0|0.513|2.911||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.911|0.513|0.6508
91508161|NCT02659020|182888797|SUPERIORITY||Hazard Ratio (HR)|0.661||||0.073|TWO_SIDED|95.0|0.419|1.041||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.041|0.419|0.073
91508162|NCT02659020|182888797|SUPERIORITY||Hazard Ratio (HR)|0.703||||0.225|TWO_SIDED|95.0|0.395|1.253||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.253|0.395|0.225
91532698|NCT01052662|182942171|SUPERIORITY_OR_OTHER||Slope|-0.00935|STANDARD_ERROR_OF_MEAN|0.00356|=|0.00874|TWO_SIDED||||||Mixed Models Analysis||Z = -2.62209|We modeled the mean proportion of weekly opioid use using a mixed-effect linear regression approach to assess the treatment effect, the time effect and the interaction of time x treatment effect while adjusting for the baseline mean proportion of weekly opioid use with baseline COWS, Addiction Severity Index (ASI) psychiatric and legal composite scores as covariates.||||=0.00874
91508163|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.332|TWO_SIDED|95.0|0.834|1.764||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.764|0.834|0.332
91753432|NCT02699450|183399751|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.78|TWO_SIDED|80.0|-9.8|6.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.2|-9.8|0.78
91508164|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.389|TWO_SIDED|95.0|0.514|1.287||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||1.287|0.514|0.389
91508165|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.598||||0.02|TWO_SIDED|95.0|0.386|0.926||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||0.926|0.386|0.020
91508166|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.821|TWO_SIDED|95.0|0.622|1.442||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.442|0.622|0.821
91508167|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.931||||0.812|TWO_SIDED|95.0|0.574|1.509||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||1.509|0.574|0.812
91532699|NCT01052662|182942172|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.64|TWO_SIDED||||||Log Rank|||||||0.64
91508168|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.162|TWO_SIDED|95.0|0.893|2.055||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||2.055|0.893|0.162
91508169|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.619|TWO_SIDED|95.0|0.55|1.413||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||1.413|0.550|0.619
91532700|NCT01052662|182942173|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4||||1.2|TWO_SIDED|||||These results are using survival curve estimates to first positive urine toxicology for any opioid. The last observation carried forward (LOCF) was used to perform our survival event analyses.|Log Rank|||||||1.2
91532701|NCT02478359|182942182|SUPERIORITY||Odds Ratio (OR)|1.09||||0.33|TWO_SIDED|95.0|0.92|1.28|||Regression, Logistic|||||1.28|0.92|0.33
91753433|NCT02699450|183399752|SUPERIORITY||Difference in Least Squares Means|-2.3||||0.78|TWO_SIDED|80.0|-12.7|8.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||8.2|-12.7|0.78
91753434|NCT02699450|183399753|SUPERIORITY||Difference in Least Squares Means|-0.5||||0.93|TWO_SIDED|80.0|-7.7|6.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.7|-7.7|0.93
91753435|NCT02699450|183399753|SUPERIORITY||Difference in Least Squares Means|-2.0||||0.69|TWO_SIDED|80.0|-8.3|4.4||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.4|-8.3|0.69
91753436|NCT02699450|183399754|SUPERIORITY||Difference in Least Squares Means|-6.5||||0.69|TWO_SIDED|80.0|-27.8|14.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||14.7|-27.8|0.69
91753437|NCT02699450|183399754|SUPERIORITY||Difference in Least Squares Means|-22.8||||0.18|TWO_SIDED|80.0|-44.5|-1.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-1.2|-44.5|0.18
91753438|NCT02699450|183399755|SUPERIORITY||Difference in Least Squares Means|-49.2||||0.07|TWO_SIDED|80.0|-84.2|-14.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-14.2|-84.2|0.07
91753439|NCT02699450|183399756|SUPERIORITY||Difference in Least Squares Means|-17.3||||0.28|TWO_SIDED|80.0|-38.0|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-38.0|0.28
91532702|NCT02478359|182942183|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.77|1.36|||Regression, Logistic|||||1.36|0.77|0.88
91508170|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.597|TWO_SIDED|95.0|0.746|1.724||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||1.724|0.746|0.597
91532703|NCT02478359|182942184|SUPERIORITY||Odds Ratio (OR)|1.05||||0.53|TWO_SIDED|95.0|0.89|1.24|||Regression, Logistic|||||1.24|0.89|0.53
91532704|NCT02478359|182942185|SUPERIORITY||Odds Ratio (OR)|1.03||||0.73|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic|||||1.20|0.88|0.73
91532705|NCT02478359|182942186|SUPERIORITY||Odds Ratio (OR)|1.13||||0.21|TWO_SIDED|95.0|0.93|1.37|||Regression, Logistic|||||1.37|0.93|0.21
91753440|NCT02699450|183399756|SUPERIORITY||Difference in Least Squares Means|-29.2||||0.05|TWO_SIDED|80.0|-47.8|-10.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-10.6|-47.8|0.05
91753441|NCT02699450|183399757|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.36|TWO_SIDED|80.0|-29.7|5.0||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.0|-29.7|0.36
91753442|NCT02699450|183399757|SUPERIORITY||Difference in Least Squares Means|-21.1||||0.13|TWO_SIDED|80.0|-38.7|-3.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.5|-38.7|0.13
91753443|NCT02699450|183399758|SUPERIORITY||Difference in Least Squares Means|-38.6||||0.07|TWO_SIDED|80.0|-65.9|-11.3||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-11.3|-65.9|0.07
91753444|NCT02699450|183399759|SUPERIORITY||Difference in Least Squares Means|-20.1||||0.12|TWO_SIDED|80.0|-36.4|-3.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.8|-36.4|0.12
91753445|NCT02699450|183399759|SUPERIORITY||Difference in Least Squares Means|-26.7||||0.02|TWO_SIDED|80.0|-41.3|-12.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-12.0|-41.3|0.02
91753446|NCT02699450|183399760|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.4948|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4948
91532706|NCT02478359|182942187|SUPERIORITY||Odds Ratio (OR)|1.1||||0.26|TWO_SIDED|95.0|0.93|1.31|||Regression, Logistic|||||1.31|0.93|0.26
91532707|NCT02478359|182942188|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91532708|NCT02478359|182942189|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
91532709|NCT02478359|182942190|SUPERIORITY|||||||0.34||||||adjusted p values|Regression, Logistic|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.34
91508171|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.766||||0.38|TWO_SIDED|95.0|0.425|1.381||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||1.381|0.425|0.380
91532710|NCT02478359|182942191|SUPERIORITY|||||||0.6|||||||Regression, Linear|||||||0.60
91753447|NCT02699450|183399760|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.496|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4960
91753448|NCT02699450|183399761|SUPERIORITY||Difference in Percentage of Participants|-2.8||||1|TWO_SIDED|80.0|-11.08|5.49||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.49|-11.08|1.0000
91753449|NCT02699450|183399762|SUPERIORITY||Difference in Percentage of Participants|-6.12||||0.5759|TWO_SIDED|80.0|-15.41|3.17||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.17|-15.41|0.5759
91753450|NCT02699450|183399762|SUPERIORITY||Difference in Percentage of Participants|3.15||||0.7437|TWO_SIDED|80.0|-5.02|11.33||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||11.33|-5.02|0.7437
91753451|NCT02699450|183399763|SUPERIORITY||Difference in Percentage of Participants|2.02||||1|TWO_SIDED|80.0|-8.6|12.64||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||12.64|-8.60|1.0000
91753452|NCT00689793|183399791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|2.5||0.69|TWO_SIDED|95.0|0.0|10.0||Significant level of treatment effect was set at p\<0.05|Regression, Linear|Level of fatigue at four weeks:dependant variable. Group allocation and level of fatigue at baseline: independant variables.||The null hypothesis was that there was no difference in fatigue VAS scores between the treatment and placebo groups at 4 weeks||10|0|0.69
91753453|NCT00689793|183399792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|6.5|<|0.05||95.0|0.0|10.0|||Regression, Linear|Hemoglobin value at four weeks : dependant variable. Group allocation and hemoglobin value at baseline : independant variables.||||10|0|<0.05
91753454|NCT00689793|183399793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|8.0|<|0.05|TWO_SIDED|95.0|0.0|30.0|||Regression, Linear|Ferritin level at 4 weeks : dependant variable. Group allocation and ferritin level at baseline: independant variables.||||30|0|<0.05
91753455|NCT00689793|183399794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.0||0.05|TWO_SIDED|95.0|0.0|6.0|||Regression, Linear|Aerobic capacity at 4 weeks : dependant variables. Group allocation and aerobic capacity at baseline : independant variable.||||6|0|0.05
91753456|NCT01811303|183399811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
91753457|NCT01811303|183399811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.016||95.0|||||ANOVA|||||||<0.016
91753458|NCT02266875|183399813|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
91753459|NCT02266875|183399814|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91753460|NCT02469714|183399884|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.04|TWO_SIDED||||||ANCOVA|||Between group comparison of total scheduled appointments from 1-13 months||||.04
91753461|NCT02469714|183399884|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.008|TWO_SIDED||||||ANCOVA|||Between group comparison of total achieved appointments from 1-13 months||||.008
91753462|NCT02469714|183399885|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.135|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.135
91753463|NCT02469714|183399886|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.077|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.077
91753464|NCT02469714|183399887|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.0005|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.0005
91753465|NCT02469714|183399888|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.06|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.060
91753466|NCT02469714|183399889|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.073|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.073
91753467|NCT02469714|183399890|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.34|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.34
91532711|NCT02478359|182942192|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
91532712|NCT02478359|182942193|SUPERIORITY|||||||0.47|||||||Regression, Linear|||||||0.47
91508172|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.046||||0.877|TWO_SIDED|95.0|0.635|1.723||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.723|0.635|0.877
91508173|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.102||||0.791|TWO_SIDED|95.0|0.568|2.139||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||2.139|0.568|0.791
91532713|NCT02478359|182942194|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
91508174|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.487|TWO_SIDED|95.0|0.454|1.443||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||1.443|0.454|0.487
91532714|NCT02478359|182942195|SUPERIORITY|||||||0.87||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.87
91532715|NCT02478359|182942196|SUPERIORITY|||||||0.7||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.70
91753468|NCT02469714|183399891|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.21|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.21
91753469|NCT00892606|183399933|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
91753470|NCT00892606|183399934|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
91753471|NCT00892606|183399935|SUPERIORITY|||||||0.0146|||||||ANOVA|||||||0.0146
91753472|NCT00140842|183399936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.0|STANDARD_DEVIATION|16.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.||||<0.05
91753473|NCT00140842|183399937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|23.7|STANDARD_DEVIATION|12.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no difference between the groups for visceral adipose tissue||||<0.05
91753474|NCT01515475|183399943|OTHER||Risk Difference (RD)|3.0||||0.72|TWO_SIDED|95.0|-12.0|18.0|||Barnard's Exact Test|||||18|-12|0.72
91753475|NCT01515475|183399943|OTHER||Risk Difference (RD)|-13.0||||0.14|TWO_SIDED|95.0|-31.0|4.0|||Barnard's Exact Test|||||4|-31|0.14
91753476|NCT01515475|183399951|OTHER||Mean Difference (Final Values)|0.6||||0.002|TWO_SIDED|99.0|0.11|1.09||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.09|0.11|0.002
91753477|NCT01515475|183399951|OTHER||Mean Difference (Final Values)|0.58||||0.002|TWO_SIDED|99.0|0.1|1.06||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.06|0.10|0.002
91753478|NCT01515475|183399951|OTHER||Mean Difference (Final Values)|0.16||||0.53|TWO_SIDED|99.0|-0.51|0.84||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.84|-0.51|0.53
91753479|NCT01515475|183399951|OTHER||Mean Difference (Final Values)|0.22||||0.38|TWO_SIDED|99.0|-0.43|0.86||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.86|-0.43|0.38
91753480|NCT01515475|183399952|OTHER||Mean Difference (Final Values)|-25.0||||0.013|TWO_SIDED|99.0|-49.0|1.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the more hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||1|-49|0.013
91753481|NCT01515475|183399952|OTHER||Hazard Ratio, log|-18.0||||0.08|TWO_SIDED|99.0|-42.0|8.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the less hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||8|-42|0.08
91753482|NCT01515475|183399953|OTHER||Mean Difference (Final Values)|0.01||||0.22|TWO_SIDED|99.0|-0.02|0.04|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.04|-0.02|0.22
91753483|NCT01515475|183399953|OTHER||Mean Difference (Final Values)|-0.02||||0.41|TWO_SIDED|99.0|-0.06|0.03|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.03|-0.06|0.41
91753484|NCT01515475|183399953|OTHER||Mean Difference (Final Values)|-0.05||||0.02|TWO_SIDED|99.0|-0.12|0.01|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.01|-0.12|0.02
91753485|NCT01515475|183399953|OTHER||Mean Difference (Final Values)|-0.07||||0.15|TWO_SIDED|99.0|-0.19|0.05|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.05|-0.19|0.15
91753486|NCT01515475|183399954|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
91753487|NCT01515475|183399954|OTHER||Mean Difference (Final Values)|-2.0||||0.79|TWO_SIDED|99.0|-18.0|14.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||14|-18|0.79
91753488|NCT01515475|183399955|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
91753489|NCT01515475|183399955|OTHER||Mean Difference (Final Values)|-4.0||||0.68|TWO_SIDED|99.0|-24.0|16.0||Results are considered statistically significant if p≤0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||16|-24|0.68
91753490|NCT01515475|183399956|OTHER||Mean Difference (Final Values)|-0.04||||0.21|TWO_SIDED|99.0|-0.12|0.05||Results are considered statistically significant if p\<0.01|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.05|-0.12|0.21
91753491|NCT01515475|183399956|OTHER||Mean Difference (Final Values)|-0.03||||0.25|TWO_SIDED|99.0|-0.1|0.04||Results are considered statistically significant if p≤0.01.|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.04|-0.10|0.25
91753492|NCT01515475|183399957|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||13|-18|0.51
91753493|NCT01515475|183399957|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|99.0|-17.0|17.0||No p-value, because there was 0% difference||||Barnard's exact test used to compare proportions between treatment groups.||17|-17|
91753494|NCT01515475|183399958|OTHER||Mean Difference (Final Values)|0.02||||0.74|TWO_SIDED|99.0|-0.11|0.14||Results are considered statistically significant if p\<0.01.|ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.||0.14|-0.11|0.74
91753495|NCT01515475|183399958|OTHER||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|99.0|-0.4|0.1|||ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.||0.1|-0.4|0.15
91753496|NCT01515475|183399959|OTHER||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|99.0|-14.0|26.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||26|-14|0.53
91753497|NCT01515475|183399959|OTHER||Mean Difference (Final Values)|-19.0||||0.02|TWO_SIDED|99.0|-40.0|2.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups.||2|-40|0.02
91753498|NCT01996592|183399965|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||"PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stress"||||<0.01
91753499|NCT01996592|183399966|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||||||<0.01
91753500|NCT00707746|183399972|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||It was estimated that the standard deviation of the percent change in LDL-C was 20%. A sample size of 30 patients was planned for this study: 20 patients in the mipomersen group and 10 patients in the placebo group. A 2-sided t-test with an alpha level of 0.05 was expected to provide ≥90% power to detect a 30% difference in LDL-C percent reduction between the 2 groups (35% reduction for the mipomersen group and 5% reduction for the placebo group).||||<0.001
91753501|NCT00707746|183399975|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon signed rank sum|||||||<0.001
91753502|NCT00707746|183399977|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91753503|NCT00707746|183399979|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
91753504|NCT00707746|183399981|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.005
91753505|NCT00707746|183399983|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
91753506|NCT00707746|183399985|SUPERIORITY_OR_OTHER|||||||0.006||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.006
91753507|NCT00707746|183399987|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
91753508|NCT00707746|183399989|SUPERIORITY_OR_OTHER|||||||0.784||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.784
91753509|NCT00707746|183399991|SUPERIORITY_OR_OTHER|||||||0.079||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.079
91753510|NCT02573246|183399995|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|-0.323|STANDARD_ERROR_OF_MEAN|0.131||0.019|TWO_SIDED|95.0|-0.59|-0.056||A priori threshold for significance was .05.|Mixed Models Analysis||The results presented are between the active right and sham conditions.|A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||-.056|-.590|0.019
91753511|NCT02573246|183399995|SUPERIORITY||Mean Difference (Net)|0.237|STANDARD_ERROR_OF_MEAN|0.133||0.08|TWO_SIDED|95.0|-0.034|0.508|||Mixed Models Analysis|||A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||.508|-.034|.08
91753512|NCT02573246|183399995|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_ERROR_OF_MEAN|0.103||0.033|TWO_SIDED|95.0|-0.434|-0.02||A priori threshold for significance was set to .05.|Mixed Models Analysis|we controlled for baseline and for the distance between the brain and the scalp||Regulation duration was transformed using a logarithmic transformation to achieve normality||-.020|-.434|.033
91753513|NCT02573246|183399996|SUPERIORITY||Mean Difference (Net)|-0.124|STANDARD_ERROR_OF_MEAN|0.184||0.51|TWO_SIDED|95.0|-0.504|0.256||A priori set threshold for statistical significance was 0.05|ANOVA|||A univariate general linear model was employed to test of regulation duration, transformed for normality.||.256|-0.504|.51
91508175|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.014||||0.976|TWO_SIDED|95.0|0.556|1.85||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.850|0.556|0.976
91508176|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.694||||0.111|TWO_SIDED|95.0|0.882|3.25||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||3.250|0.882|0.111
91508177|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.108||||0.76|TWO_SIDED|95.0|0.62|1.979||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||1.979|0.620|0.760
91508178|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.119||||0.747|TWO_SIDED|95.0|0.586|2.135||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||2.135|0.586|0.747
91508179|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.367||||0.33|TWO_SIDED|95.0|0.726|2.576||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||2.576|0.726|0.330
91508180|NCT02659020|182888798|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.411|TWO_SIDED|95.0|0.636|2.965||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||2.965|0.636|0.411
91532716|NCT02478359|182942197|SUPERIORITY|||||||0.35|||||||Regression, Linear|Adjusted P Values||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.35
91508181|NCT00393939|182888873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9222||||0.2651|TWO_SIDED|95.0|0.7156|1.1885||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Independent radiology assessment||1.1885|0.7156|0.2651
91508182|NCT00393939|182888873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.0753|TWO_SIDED|95.0|0.6921|1.0589||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Investigator's assessment||1.0589|0.6921|0.0753
91508183|NCT00393939|182888874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0018|TWO_SIDED|95.0|1.17|2.33||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Independent radiology assessment||2.33|1.17|0.0018
91508184|NCT00393939|182888874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0172|TWO_SIDED|95.0|1.03|2.02||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Investigator's assessment||2.02|1.03|0.0172
91508185|NCT00393939|182888876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1539||||0.8933|TWO_SIDED|95.0|0.9209|1.4458||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||||1.4458|0.9209|0.8933
91508186|NCT01494610|182888880|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.508|||||TWO_SIDED|90.0|1.366|1.665|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.665|1.366|
91532717|NCT02478359|182942198|SUPERIORITY|||||||0.09||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.09
91508187|NCT01494610|182888880|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.598|||||TWO_SIDED|90.0|1.369|1.864|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.864|1.369|
91508188|NCT01494610|182888880|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.421|||||TWO_SIDED|90.0|1.274|1.584|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.584|1.274|
91508189|NCT01494610|182888881|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.928|||||TWO_SIDED|90.0|0.886|0.971|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.971|0.886|
91508190|NCT01494610|182888881|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.892|||||TWO_SIDED|90.0|0.848|0.939|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.939|0.848|
91532718|NCT02478359|182942199|SUPERIORITY|||||||0.82||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.82
91532719|NCT02478359|182942200|SUPERIORITY|||||||0.16||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.16
91532720|NCT02478359|182942201|SUPERIORITY|||||||0.86||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.86
91532721|NCT02478359|182942202|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
91532722|NCT02478359|182942203|SUPERIORITY||Odds Ratio (OR)|1.05||||0.69|TWO_SIDED|95.0|0.82|1.35|||Regression, Logistic|||||1.35|0.82|0.69
91532723|NCT02478359|182942204|SUPERIORITY||Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.35|1.11|||Regression, Logistic|||||1.11|0.35|0.11
91753514|NCT02573246|183399996|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.18||0.97|TWO_SIDED|95.0|-0.364|0.378|||ANOVA|||||.378|-.364|.97
91753515|NCT02573246|183399996|SUPERIORITY||Mean Difference (Net)|0.147993|STANDARD_ERROR_OF_MEAN|0.167031||0.39|TWO_SIDED|95.0|-0.215936|0.511921||A priori set significance threshold was 0.05|t-test, 2 sided|||A t test of the variable 'time it took to return to HR baseline', transformed for normality was used to examine between condition differences at the 1 month follow up.||0.511921|-0.215936|0.39
91753516|NCT02573246|183399997|SUPERIORITY|HF-HRV was transformed using the function lg10\*(HF-HRV\*1000000) in order to be normally distributed.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.51||0.022|TWO_SIDED|95.0|0.044|0.267||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||In the original study (CR+active left rTMS vs CR+ active right rTMS vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation.||.267|.044|.022
91508191|NCT01494610|182888881|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.889|1.049|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.049|0.889|
91508192|NCT02346240|182888933|SUPERIORITY||Estimated difference in responder rate|61.6|||||TWO_SIDED|95.0|52.1|71.2|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||71.2|52.1|
91508193|NCT02346240|182888933|SUPERIORITY||Estimated difference in responder rate|56.2|||||TWO_SIDED|95.0|46.4|66.0|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||66.0|46.4|
91508194|NCT02346240|182888933|SUPERIORITY||Odds Ratio (OR)|37.988|||<|0.0001|TWO_SIDED|95.0|11.312|127.576||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||127.576|11.312|<0.0001
91508195|NCT02346240|182888933|SUPERIORITY||Odds Ratio (OR)|30.023|||<|0.0001|TWO_SIDED|95.0|8.971|100.481||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||100.481|8.971|<0.0001
91753517|NCT02573246|183399997|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0499|TWO_SIDED|95.0|0.000037|0.213074|||Mixed Models Analysis|||MMANOVA||0.213074|0.000037|0.0499
91753518|NCT02573246|183399997|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|0.172|STANDARD_DEVIATION|0.38|<|1e-06|TWO_SIDED|95.0|0.129|0.215||Significance threshold was set at p = 0.05.|Mixed Models Analysis||The MMANOVA analysis used an unstructured covariance structure.|In the supplemental study (CR+active left rTMS with functional targeting vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation when compared with sham.||.215|.129|<.000001
91753519|NCT02573246|183399998|SUPERIORITY||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.091544||0.236|TWO_SIDED|95.0|-0.078086|0.300661||A priori threshold was set to 0.05.|ANCOVA|Brain to skull difference and intake difference in dlPFC activation between regulation and feeling negative were included as confounds.|Parameter estimate is the value of the difference between active stimulation and sham stimulation.|Difference between treatment conditions in dlPFC activation change between feeling negative emotions and downregulation of negative affect a week after intervention, when controlling for baseline activation difference||0.300661|-0.078086|.236
91753520|NCT02573246|183399998|SUPERIORITY||Mean Difference (Net)|0.359024|STANDARD_ERROR_OF_MEAN|0.144067||0.020347|TWO_SIDED|95.0|0.061|0.657049||Threshold was set at 0.05 a priori|ANCOVA|Brain to skull difference and intake difference in vlpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vlPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted using FSL featquery. A univariate general linear model excluding one outlier from the active condition was conducted for this outcome measure.||0.657049|0.061000|0.020347
91753521|NCT02573246|183399998|SUPERIORITY||Mean Difference (Net)|0.221683|STANDARD_ERROR_OF_MEAN|0.461481||0.635|TWO_SIDED|95.0|-0.732963|1.17633||A priori threshold was set to .05|ANCOVA|Brain to skull difference and intake difference in vmpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vmPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with FSL featquery.||1.176330|-0.732963|0.635
91753522|NCT02573246|183399998|SUPERIORITY||Mean Difference (Net)|0.179412|STANDARD_ERROR_OF_MEAN|0.178029||0.324|TWO_SIDED|95.0|-0.188868|0.547692||a priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in amygdala activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the amygdala when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with featquery (FSL).||0.547692|-0.188868|.324
91753523|NCT02573246|183399998|SUPERIORITY||Mean Difference (Net)|0.021231|STANDARD_ERROR_OF_MEAN|0.071185||0.76819|TWO_SIDED|95.0|-0.126027|0.168489||A priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in insula activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the insula when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. FSL featquery tool was used to extract ROI (region of interest) data.||0.168489|-0.126027|0.768190
91753524|NCT02573246|183399999|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.455||0.69|TWO_SIDED|95.0|-0.553|1.293||a priori threshold for significance was 0.05|ANOVA|||Likert-type questions about acceptability were rated on a scale from 0 (not at all) to 9 (extremely) and then averaged to create a mean for acceptability. This average score was normally distributed and therefore was entered into a univariate general linear model where acceptability was entered as a dependent variable and condition as a fixed factor.||1.293|-0.553|0.69
91753525|NCT02573246|183399999|SUPERIORITY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.43||0.53|TWO_SIDED|95.0|-0.592|1.139|||ANOVA|||||1.139|-.592|.53
91753526|NCT02573246|183399999|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.45||0.15|TWO_SIDED|95.0|-1.59|0.27||a priory threshold for significance was .05|t-test, 2 sided|||we compared differences in acceptability between conditions using an independent samples t-test (acceptability was normally distributed)||0.27|-1.59|0.15
91532724|NCT02478359|182942205|SUPERIORITY||Odds Ratio (OR)|0.84||||0.21|TWO_SIDED|95.0|0.65|1.1|||Regression, Logistic|||||1.10|0.65|0.21
91753527|NCT02573246|183400000|SUPERIORITY||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.304||0.551|TWO_SIDED|95.0|-0.322|0.912||a priori threshold was set to 0.05|ANOVA|||We compared differences between conditions in the perceived feasibility of the procedures. Feasibility average was normally distributed and therefore a general linear model, univariate was employed to test between condition effects.||0.912|-0.322|0.551
91508196|NCT02346240|182888933|SUPERIORITY||Estimated difference in responder rate|13.4|||||TWO_SIDED|95.0|2.7|24.1|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||24.1|2.7|
91753528|NCT02573246|183400000|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.281||0.995|TWO_SIDED|95.0|-0.567|0.571|||ANOVA|||||.571|-.567|.995
91508197|NCT02346240|182888933|SUPERIORITY||Estimated difference in responder rate|8.0|||||TWO_SIDED|95.0|-2.9|18.9|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||18.9|-2.9|
91753529|NCT02573246|183400000|SUPERIORITY||Mean Difference (Net)|-0.09957|STANDARD_ERROR_OF_MEAN|0.371||0.791|TWO_SIDED|95.0|-0.8672|0.6681||A priori threshold for statistical significance was set to 0.05|t-test, 2 sided|df = 23||We examined differences in feasibility between the active and sham condition in the sub-study where fMRI targeting was utilized. Average feasibility was normally distributed and therefore an independent samples t-test was used to test this outcome.||0.6681|-0.8672|0.791
91753530|NCT02573246|183400001|SUPERIORITY||Mean Difference (Net)|6.04|STANDARD_ERROR_OF_MEAN|8.048||0.61|TWO_SIDED|95.0|-9.522964|21.60462||A priori threshold was set to 0.05|Mixed Models Analysis|||To test the long-term effects of the intervention, a MMANOVA model was conducted examining between-condition differences at the 1-week and 1-month follow-up in the OQ-45. Baseline was co-varied.||21.604620|-9.522964|0.61
91753531|NCT02573246|183400001|SUPERIORITY||Mean Difference (Net)|-0.906|STANDARD_ERROR_OF_MEAN|7.37||0.9|TWO_SIDED|95.0|-15.83|14.02||a priori threshold was set to .05|Mixed Models Analysis|||||14.02|-15.83|.90
91753532|NCT02573246|183400001|SUPERIORITY||Mean Difference (Net)|10.46|STANDARD_ERROR_OF_MEAN|7.93||0.2|TWO_SIDED|95.0|-5.971581|26.892619||threshold was set to 0.05 a priori|Mixed Models Analysis||HLM models used a compound symmetry covariance structure.|||26.892619|-5.971581|.20
91753533|NCT02573246|183400002|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.258||0.034|TWO_SIDED|95.0|-1.062356|-0.043203||A priori threshold was set to .05 for significance.|Mixed Models Analysis|Subjective Units of Distress (SUDS) right before the intervention were co-varied as baseline.|Results reported are for active left vs. sham comparison.|Hypothesized that active neurostimulation would lead to lower daily distress than sham stimulation. We used a hierarchical linear model (HLM) for this analysis with an identity covariance structure (random intercept and random slope).||-0.043203|-1.062356|.034
91753534|NCT02573246|183400002|SUPERIORITY||Mean Difference (Net)|0.631|STANDARD_ERROR_OF_MEAN|0.404||0.133|TWO_SIDED|95.0|-0.208|1.47||A priori set threshold was .05|Mixed Models Analysis|||Hypothesized that active neurostimulation will lead to less daily distress than sham neurostimulation during the ambulatory data collection. An HLM analysis was conducted using an unstructured covariance structure and reported distress right before the intervention as baseline.||1.47|-.208|.133
91753535|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|-1.300772|STANDARD_ERROR_OF_MEAN|2.670936||0.629061|TWO_SIDED|95.0|-6.708548|4.107||A priori threshold was set to .05|Mixed Models Analysis|Intake values for the dependent measures were covaried. The time by condition interaction term was included.||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less functional impairment than sham neurostimulation.||4.107|-6.708548|0.629061
91753536|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|-0.977394|STANDARD_ERROR_OF_MEAN|2.605189||0.71|TWO_SIDED|95.0|-6.255223|4.300434|||Mixed Models Analysis|||We expected lower functional impairment in the active right versus the sham condition.||4.300434|-6.255223|0.71
91753537|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|-3.292137|STANDARD_ERROR_OF_MEAN|3.314194||0.331|TWO_SIDED|95.0|-10.157811|3.573537||A priori set threshold was .05|Mixed Models Analysis|Baseline WSAS was covaried|The analysis compared sham versus active stimulation.|Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology in the substudy also. We expected active neurostimulation to lead to less impairment than sham neurostimulation.||3.573537|-10.157811|0.331
91753538|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|0.284589|STANDARD_ERROR_OF_MEAN|0.276698||0.31|TWO_SIDED|95.0|-0.27603|0.845209||A priori set threshold for significance was 0.05|Mixed Models Analysis|baseline was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.845209|-0.276030|0.31
91753539|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|10.129377|STANDARD_ERROR_OF_MEAN|9.150339||0.275257|TWO_SIDED|95.0|-8.394724|28.653479|||Mixed Models Analysis|||We hypothesized that active right neurostimulation would yield lower emotional dysregulation after the intervention when compared to sham neurostimulation.||28.653479|-8.394724|0.275257
91753540|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|-13.187|STANDARD_ERROR_OF_MEAN|6.212753||0.044|TWO_SIDED|95.0|-26.002351|-0.372281||A priori set significance threshold was 0.05|Mixed Models Analysis|||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less emotional dysregulation than sham neurostimulation.||-0.372281|-26.002351|0.044
91753541|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|0.927909|STANDARD_ERROR_OF_MEAN|9.603423||0.924|TWO_SIDED|95.0|-18.508252|20.364071||A priori set threshold for statistical significance was 0.05|Mixed Models Analysis|baseline was covaried||We expected active stimulation to lead to less emotional dysregulation than sham neurostimulation. A MMANOVA model was employed, controlling for baseline.||20.364071|-18.508252|.924
91753542|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|-0.017547|STANDARD_ERROR_OF_MEAN|0.267983||0.95|TWO_SIDED|95.0|-0.560994|0.525901|||Mixed Models Analysis|||we expected more use of cr following active right neurostimulation then after following sham neurostimulation.||0.525901|-0.560994|.95
91508198|NCT02346240|182888933|SUPERIORITY||Odds Ratio (OR)|1.756|||=|0.0152|TWO_SIDED|95.0|1.114|2.768||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.768|1.114|=0.0152
91508199|NCT02346240|182888933|SUPERIORITY||Odds Ratio (OR)|1.388|||=|0.1523|TWO_SIDED|95.0|0.886|2.175||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.175|0.886|=0.1523
91508200|NCT02346240|182888934|SUPERIORITY||Estimated difference in responder rate|48.5|||||TWO_SIDED|95.0|39.33|57.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||57.63|39.33|
91508201|NCT02346240|182888934|SUPERIORITY||Estimated difference in responder rate|37.9|||||TWO_SIDED|95.0|28.88|46.96|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.96|28.88|
91508202|NCT02346240|182888934|SUPERIORITY||Odds Ratio (OR)|56.129|||<|0.0001|TWO_SIDED|95.0|7.787|404.555||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||404.555|7.787|<0.0001
91532725|NCT02478359|182942206|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6|TWO_SIDED|95.0|0.84|1.36|||Regression, Logistic|||||1.36|0.84|0.60
91532726|NCT02478359|182942207|SUPERIORITY||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||||1.28|0.66|0.63
91753543|NCT02573246|183400003|SUPERIORITY||Mean Difference (Net)|-0.096719|STANDARD_ERROR_OF_MEAN|0.389897||0.806|TWO_SIDED|95.0|-0.900919|0.707481||A priori set significance threshold was 0.05|Mixed Models Analysis|Baseline use of cognitive restructuring was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.707481|-0.900919|.806
91532727|NCT02478359|182942208|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||||1.35|0.68|0.80
91753544|NCT02256267|183400039|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0771|||||TWO_SIDED|90.0|0.0671|0.0886||||||||0.0886|0.0671|
91753545|NCT02256267|183400040|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0467|||||TWO_SIDED|90.0|0.0376|0.0581||||||||0.0581|0.0376|
91753546|NCT01443130|183400056|SUPERIORITY_OR_OTHER|||||||0.2441||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2441
91753547|NCT01443130|183400056|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
91753548|NCT01443130|183400057|SUPERIORITY_OR_OTHER|||||||0.4941||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4941
91753549|NCT01443130|183400057|SUPERIORITY_OR_OTHER|||||||0.499||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4990
91753550|NCT01443130|183400058|SUPERIORITY_OR_OTHER|||||||0.3089||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3089
91753551|NCT01443130|183400058|SUPERIORITY_OR_OTHER|||||||0.6973||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.6973
91753552|NCT01443130|183400059|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||1.00
91753553|NCT01443130|183400059|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.00
91508203|NCT02346240|182888934|SUPERIORITY||Odds Ratio (OR)|36.566|||=|0.0004|TWO_SIDED|95.0|5.061|264.196||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||264.196|5.061|=0.0004
91508204|NCT02346240|182888935|SUPERIORITY||Estimated difference in responder rate|33.8|||||TWO_SIDED|95.0|20.68|46.98|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.98|20.68|
91508205|NCT02346240|182888935|SUPERIORITY||Estimated difference in responder rate|31.0|||||TWO_SIDED|95.0|18.18|43.8|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||43.80|18.18|
91532728|NCT02478359|182942209|SUPERIORITY|||||||0.06||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.06
91508206|NCT02346240|182888935|SUPERIORITY||Odds Ratio (OR)|39.949|||<|0.0001|TWO_SIDED|95.0|8.407|189.828||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||189.828|8.407|<0.0001
91508207|NCT02346240|182888935|SUPERIORITY||Odds Ratio (OR)|35.084|||<|0.0001|TWO_SIDED|95.0|7.363|167.179||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||167.179|7.363|<0.0001
91532729|NCT02478359|182942210|SUPERIORITY|||||||0.07||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.07
91753554|NCT01443130|183400060|SUPERIORITY_OR_OTHER|||||||0.4979||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4979
91753555|NCT01443130|183400060|SUPERIORITY_OR_OTHER|||||||0.1166||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1166
91753556|NCT01443130|183400061|SUPERIORITY_OR_OTHER|||||||0.6237||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.6237
91753557|NCT01443130|183400061|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
91753558|NCT01443130|183400062|SUPERIORITY_OR_OTHER|||||||0.5187||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5187
91753559|NCT01443130|183400062|SUPERIORITY_OR_OTHER|||||||0.2163||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.2163
91753560|NCT01443130|183400063|SUPERIORITY_OR_OTHER|||||||0.5959||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5959
91753561|NCT01443130|183400063|SUPERIORITY_OR_OTHER|||||||0.8127||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.8127
91753562|NCT01443130|183400064|SUPERIORITY_OR_OTHER|||||||0.2566||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2566
91753563|NCT01443130|183400064|SUPERIORITY_OR_OTHER|||||||0.7839||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.7839
91753564|NCT01443130|183400065|SUPERIORITY_OR_OTHER|||||||0.2553||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2553
91753565|NCT01443130|183400065|SUPERIORITY_OR_OTHER|||||||0.4354||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4354
91753566|NCT01443130|183400066|SUPERIORITY_OR_OTHER|||||||0.369||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3690
91753567|NCT01443130|183400066|SUPERIORITY_OR_OTHER|||||||0.4947||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4947
91753568|NCT01443130|183400067|SUPERIORITY_OR_OTHER|||||||0.063||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0630
91508208|NCT02346240|182888936|SUPERIORITY||Estimated difference in responder rate|70.9|||||TWO_SIDED|95.0|62.15|79.59|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||79.59|62.15|
91508209|NCT02346240|182888936|SUPERIORITY||Estimated difference in responder rate|64.4|||||TWO_SIDED|95.0|55.12|73.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||73.63|55.12|
91753569|NCT01443130|183400067|SUPERIORITY_OR_OTHER|||||||0.4184||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4184
91753570|NCT01443130|183400068|SUPERIORITY_OR_OTHER|||||||0.0268||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0268
91753571|NCT01443130|183400068|SUPERIORITY_OR_OTHER|||||||0.1646||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1646
91753572|NCT01443130|183400069|SUPERIORITY_OR_OTHER|||||||0.4501||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4501
91753573|NCT01443130|183400069|SUPERIORITY_OR_OTHER|||||||0.1758||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1758
91759524|NCT02391363|183411775|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
91759525|NCT02391363|183411776|SUPERIORITY|||||||0.001||||||Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.001
91759526|NCT02391363|183411777|SUPERIORITY|||||||0.42||||||Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.42
91759527|NCT02391363|183411778|SUPERIORITY|||||||0.85||||||Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.85
91759528|NCT02391363|183411779|SUPERIORITY|||||||0.55||||||Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.55
91753574|NCT01266590|183400071|SUPERIORITY_OR_OTHER|||||||0.0664||95.0|||||Wilcoxon Signed Rank|||||||0.0664
91753575|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies \<1250 gm||||0.571
91753576|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \<1250 gm while anemic||||0.345
91753577|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies \>1250 gm||||0.006
91753578|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \>1250 gm while anemic||||0.035
91753579|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.910
91753580|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.850
91753581|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.507|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.507
91753582|NCT00167388|183400092|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.286
91753583|NCT05501795|183400104|OTHER||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|5.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
91753584|NCT02888743|183400128|SUPERIORITY||Difference between proportions|0.0||||0.99|TWO_SIDED|90.0|-14.6|14.6|||Chi-squared||Arm A compared with Arm C; normal approximation for confidence interval|||14.6|-14.6|0.99
91753585|NCT02888743|183400128|SUPERIORITY||Difference between proportions|-3.8||||0.64|TWO_SIDED|90.0|-17.3|9.6|||Chi-squared||Arm B compared with Arm C; normal approximation used for confidence interval.|||9.6|-17.3|0.64
91753586|NCT02888743|183400129|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.92|TWO_SIDED|90.0|0.6|1.58|||Regression, Cox|||||1.58|0.60|0.92
91753587|NCT02888743|183400129|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|90.0|0.5|1.38|||Regression, Cox|||||1.38|0.50|0.55
91753588|NCT02888743|183400130|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.24|TWO_SIDED|90.0|0.3|1.22|||Regression, Cox|||||1.22|0.30|0.24
91753589|NCT02888743|183400130|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.44|TWO_SIDED|90.0|0.36|1.45|||Regression, Cox|||||1.45|0.36|0.44
91753590|NCT02888743|183400134|SUPERIORITY|||||||0.68||||||Unadjusted p-value.|Wilcoxon (Mann-Whitney)|||||||0.68
91753591|NCT03344172|183400140|SUPERIORITY||Odds Ratio (OR)|0.52||||0.63|TWO_SIDED|95.0|0.3|6.71|||Fisher Exact|||||6.71|0.30|0.63
91753592|NCT03344172|183400141|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.52||0.13|TWO_SIDED|95.0|-1.0|-0.25|||t-test, 2 sided|||||-0.25|-1.00|0.13
91753593|NCT01804582|183400151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Mixed Models Analysis|||An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.||||.15
91753594|NCT01804582|183400152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.53|TWO_SIDED||||||Mixed Models Analysis||Cohen's d was calculated to measure the estimation parameter.|||||.53
91753595|NCT01804582|183400153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||.80
91753596|NCT01804582|183400154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||.33
91753597|NCT01804582|183400155|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wald Chi-Squared|||||||.21
91753598|NCT01804582|183400156|SUPERIORITY_OR_OTHER_LEGACY||Phi|0.19||||0.005|TWO_SIDED||||||Chi-squared|Chi Squared (1, N = 229) = 7.99.||The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)||||.005
91753599|NCT00159913|183400162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|3.98||0.056||95.0|-0.19|15.6||No adjustments for multiple comparisons have been made.|ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||15.60|-0.19|0.056
91753600|NCT00159913|183400162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.81|STANDARD_ERROR_OF_MEAN|5.0||||95.0|-6.11|13.73|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||13.73|-6.11|
91753601|NCT00159913|183400162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.33|STANDARD_ERROR_OF_MEAN|4.84||||95.0|1.72|20.94|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||20.94|1.72|
91753602|NCT00159913|183400162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.98|STANDARD_ERROR_OF_MEAN|4.85||||95.0|-1.64|17.6|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||17.60|-1.64|
91753603|NCT00159913|183400163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.172||95.0|-7.5|1.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.3|-7.5|0.172
91753604|NCT00159913|183400163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.1||||95.0|-4.5|7.6|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||7.6|-4.5|
91753605|NCT00159913|183400163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-8.9|1.9|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.9|-8.9|
91753606|NCT00159913|183400163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-12.4|-2.1|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||-2.1|-12.4|
91508210|NCT02346240|182888936|SUPERIORITY||Odds Ratio (OR)|76.277|||<|0.0001|TWO_SIDED|95.0|17.952|324.094||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.094|17.952|<0.0001
91508211|NCT02346240|182888936|SUPERIORITY||Odds Ratio (OR)|55.413|||<|0.0001|TWO_SIDED|95.0|13.135|233.782||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||233.782|13.135|<0.0001
91508212|NCT02346240|182888937|SUPERIORITY||Estimated difference in responder rate|55.0|||||TWO_SIDED|95.0|45.59|64.35|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.35|45.59|
91508213|NCT02346240|182888937|SUPERIORITY||Estimated difference in responder rate|44.9|||||TWO_SIDED|95.0|35.39|54.49|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.49|35.39|
91532730|NCT02478359|182942211|SUPERIORITY|||||||0.67||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.67
91508214|NCT02346240|182888937|SUPERIORITY||Odds Ratio (OR)|40.717|||<|0.0001|TWO_SIDED|95.0|9.741|170.198||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.198|9.741|<0.0001
91508215|NCT02346240|182888937|SUPERIORITY||Odds Ratio (OR)|27.165|||<|0.0001|TWO_SIDED|95.0|6.504|113.453||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||113.453|6.504|<0.0001
91508216|NCT02346240|182888938|SUPERIORITY||Estimated difference in responder rate|48.8|||||TWO_SIDED|95.0|34.22|63.41|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||63.41|34.22|
91508217|NCT02346240|182888938|SUPERIORITY||Estimated difference in responder rate|39.5|||||TWO_SIDED|95.0|25.58|53.38|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||53.38|25.58|
91753607|NCT00159913|183400164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.0||0.041||95.0|-8.0|-0.2|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-0.2|-8.0|0.041
91753608|NCT00159913|183400164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-5.9|4.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||4.7|-5.9|
91753609|NCT00159913|183400164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-9.3|0.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||0.3|-9.3|
91753610|NCT00159913|183400164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|2.3||||95.0|-11.7|-2.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-2.7|-11.7|
91753611|NCT00159913|183400165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|2.36||0.795||95.0|-4.07|5.3|||ANCOVA|The model included the covariates etiology and weight group||||5.30|-4.07|0.795
91753612|NCT00159913|183400165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|2.99||||95.0|-3.31|8.54|||ANCOVA|The model included the covariates etiology and weight group||||8.54|-3.31|
91753613|NCT00159913|183400165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.92||||95.0|-7.09|4.5|||ANCOVA|The model included the covariates etiology and weight group||||4.50|-7.09|
91753614|NCT00159913|183400165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.24|6.28|||ANCOVA|The model included the covariates etiology and weight group||||6.28|-5.24|
91753615|NCT00159913|183400166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.24|STANDARD_ERROR_OF_MEAN|6.2||0.139||95.0|-3.05|21.54|||ANCOVA|The model included the covariates etiology and weight group||||21.54|-3.05|0.139
91753616|NCT00159913|183400166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|7.84||||95.0|-5.21|25.9|||ANCOVA|The model included the covariates etiology and weight group||||25.90|-5.21|
91753617|NCT00159913|183400166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.43|STANDARD_ERROR_OF_MEAN|7.67||||95.0|-3.78|26.64|||ANCOVA|The model included the covariates etiology and weight group||||26.64|-3.78|
91753618|NCT00159913|183400166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|7.62||||95.0|-9.16|21.08|||ANCOVA|The model included the covariates etiology and weight group||||21.08|-9.16|
91753619|NCT00159913|183400167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1||0.172||95.0|-7.1|1.3|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.3|-7.1|0.172
91753620|NCT00159913|183400167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.5|5.9|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||5.9|-5.5|
91753621|NCT00159913|183400167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-8.5|1.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.7|-8.5|
91753622|NCT00159913|183400167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-10.3|-0.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||-0.7|-10.3|
91753623|NCT00159913|183400168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015||95.0|0.14|1.34|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.34|0.14|0.015
91753624|NCT00159913|183400168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.41||||95.0|-0.1|1.52|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.52|-0.10|
91753625|NCT00159913|183400168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.37||||95.0|-0.12|1.35|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.35|-0.12|
91753626|NCT00159913|183400168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.35||||95.0|0.21|1.58|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.58|0.21|
91532731|NCT02478359|182942212|SUPERIORITY|||||||0.13||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.13
91753627|NCT00159913|183400169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.64||0.44||95.0|-1.77|0.77|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.77|-1.77|0.440
91753628|NCT00159913|183400169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.88||||95.0|-1.91|1.57|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.57|-1.91|
91753629|NCT00159913|183400169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.78||||95.0|-1.73|1.36|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.36|-1.73|
91753630|NCT00159913|183400169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.75||||95.0|-2.61|0.33|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.33|-2.61|
91753631|NCT00159913|183400170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.93||0.75||95.0|-4.45|3.21|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||3.21|-4.45|0.750
91753632|NCT00159913|183400170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|2.57||||95.0|-4.21|5.95|||ANCOVA|||||5.95|-4.21|
91753633|NCT00159913|183400170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.49||||95.0|-4.68|5.15|||ANCOVA|||||5.15|-4.68|
91753634|NCT00159913|183400170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.96|STANDARD_ERROR_OF_MEAN|2.23||||95.0|-7.37|1.45|||ANCOVA|||||1.45|-7.37|
91753635|NCT00159913|183400171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|1.51||0.784||95.0|-3.41|2.58|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||2.58|-3.41|0.784
91753636|NCT00159913|183400171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.97||||95.0|-3.49|4.3|||ANCOVA|||||4.30|-3.49|
91753637|NCT00159913|183400171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.96||||95.0|-5.99|1.77|||ANCOVA|||||1.77|-5.99|
91753638|NCT00159913|183400171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.77||||95.0|-3.06|3.97|||ANCOVA|||||3.97|-3.06|
91753639|NCT00159913|183400172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.184||95.0|0.75|4.45|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||4.45|0.75|0.184
91753640|NCT00159913|183400172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.409||95.0|0.18|2.01|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||2.01|0.18|0.409
91753641|NCT00159913|183400172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.146||95.0|0.75|6.69|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||6.69|0.75|0.146
91753642|NCT00159913|183400172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.52||||0.006||95.0|1.56|13.1|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||13.10|1.56|0.006
91753643|NCT00159913|183400173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.89|STANDARD_ERROR_OF_MEAN|4.35||0.179||95.0|-2.74|14.53|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||14.53|-2.74|0.179
91753644|NCT00159913|183400173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|5.35||||95.0|-9.49|11.77|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||11.77|-9.49|
91753645|NCT00159913|183400173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|5.36||||95.0|0.66|21.96|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||21.96|0.66|
91753646|NCT00159913|183400173|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.24|STANDARD_ERROR_OF_MEAN|5.16||||95.0|-5.02|15.5|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||15.50|-5.02|
91753647|NCT00385723|183400174|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED|95.0|-0.19|-0.028||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months||-0.028|-0.19|0.03
91753648|NCT00385723|183400174|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.004|TWO_SIDED|95.0|-0.22|-0.052||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.052|-0.22|0.004
91753649|NCT00385723|183400175|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.41|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.62|-0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months.||-0.21|-0.62|0.0003
91753650|NCT00385723|183400175|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.43|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.64|-0.22||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.22|-0.64|0.0002
91753651|NCT00385723|183400176|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.8|TWO_SIDED|95.0|-0.64|0.18||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.18|-0.64|0.80
91753652|NCT00385723|183400176|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.2|STANDARD_ERROR_OF_MEAN|0.21||1|TWO_SIDED|95.0|-0.61|0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.21|-0.61|1.0
91753653|NCT00413010|183400178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.48||||95.0|-2.16|-0.26|||Mixed Models Analysis|Adjusted for treatment, pooled center baseline, HAM-A total score,time,and treatment-by time|Since an interim analysis was conducted and the sample size was larger than the targeted 173 subjects per group, a critical t-value adjustment was 1.977, yielding an adjusted 95% CI shown above.|Null hypothesis: no difference between Pregabalin (150-600 mg/day) BID and Placebo BID treatment groups. An initial sample size of 173 subjects per double-blind treatment group was calculated to provide at least 90% power to detect an effect size (ie, difference in the true means between 2 treatment groups/standard deviation) of 0.36 for the HAM-A total score change from Baseline using a 2-sided nominal significance level of 4.9%.||-0.26|-2.16|
91753654|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.49||||95.0|-2.3|-0.4|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 1||-0.4|-2.3|
91753655|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.59||||95.0|-2.2|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 2||0.1|-2.2|
91753656|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.62||||95.0|-2.7|-0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 3||-0.2|-2.7|
91753657|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.6|-0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 4||-0.1|-2.6|
91753658|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.68||||95.0|-2.1|0.5|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 5||0.5|-2.1|
91753659|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.67||||95.0|-2.5|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 6||0.1|-2.5|
91753660|NCT00413010|183400179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.77||||95.0|-2.9|0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 8||0.2|-2.9|
91753661|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.35||||||95.0|1.37|8.24||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at each week with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||8.24|1.37|
91753662|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||||95.0|0.9|2.87||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.87|0.90|
91753663|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15||||||95.0|1.76|5.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||5.66|1.76|
91753664|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|1.06|3.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||3.05|1.06|
91753665|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||||95.0|0.9|2.73||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.73|0.90|
91753666|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||||95.0|0.86|2.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.66|0.86|
91753667|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||||95.0|1.08|3.22||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||3.22|1.08|
91753668|NCT00413010|183400180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||||95.0|1.12|2.79||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (last observation carried forward, LOCF)||2.79|1.12|
91753669|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||||95.0|0.94|8.8||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 1||8.80|0.94|
91753670|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||||95.0|0.72|3.06||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 2||3.06|0.72|
91753671|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.08||||||95.0|1.09|3.97||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 3||3.97|1.09|
91753672|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|0.99|3.28||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 4||3.28|0.99|
91753673|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.82|2.85||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 5||2.85|0.82|
91753674|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||||95.0|0.71|2.48||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 6||2.48|0.71|
91753675|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||||95.0|0.85|2.83||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8||2.83|0.85|
91753676|NCT00413010|183400181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.92|2.53|||Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8 Last Observation Carried Foward (LOCF)||2.53|0.92|
91753677|NCT00413010|183400182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0137||||||P-value corresponds to the 2-sided log-rank test.|Log Rank|2-sided log-rank test||Kaplan Meier product limit estimate for calculating median time in days to onset sustained HAM-A Improvement.||||0.0137
91753678|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||||95.0|0.96|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the CGI-I responders at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||2.47|0.96|
91508218|NCT02346240|182888938|SUPERIORITY||Odds Ratio (OR)|72.278|||<|0.0001|TWO_SIDED|95.0|14.65|356.602||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||356.602|14.650|<0.0001
91753679|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||||95.0|1.01|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.47|1.01|
91753680|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||||95.0|1.09|2.82||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||2.82|1.09|
91508219|NCT02346240|182888938|SUPERIORITY||Odds Ratio (OR)|49.527|||<|0.0001|TWO_SIDED|95.0|10.002|245.256||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||245.256|10.002|<0.0001
91508220|NCT02942017|182888941|SUPERIORITY||Least Square (LS) Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.019||0.016|TWO_SIDED|95.0|-4.52|-0.48|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.48|-4.52|0.0160
91508221|NCT02942017|182888942|SUPERIORITY||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|1.271||0.671|TWO_SIDED|95.0|-1.98|3.07|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.07|-1.98|0.6710
91508222|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.738||0.4216|TWO_SIDED|95.0|-2.06|0.87|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.87|-2.06|0.4216
91508223|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.905||0.3947|TWO_SIDED|95.0|-2.57|1.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.02|-2.57|0.3947
91508224|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.962||0.328|TWO_SIDED|95.0|-2.86|0.96|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.96|-2.86|0.3280
91508225|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.994||0.2522|TWO_SIDED|95.0|-3.12|0.83|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-3.12|0.2522
91753681|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||||95.0|0.77|2.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||2.05|0.77|
91753682|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||||95.0|0.72|2.11||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.11|0.72|
91508226|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.091||0.1431|TWO_SIDED|95.0|-3.78|0.55|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-3.78|0.1431
91753683|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||||95.0|0.84|2.5|||Regression, Logistic|P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.50|0.84|
91532732|NCT02478359|182942213|SUPERIORITY|||||||0.34||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.34
91753684|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||||95.0|0.61|1.84||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||1.84|0.61|
91753685|NCT00413010|183400183|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||||95.0|0.71|1.76||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (LOCF) Last Observation Carried Forward||1.76|0.71|
91753686|NCT00413010|183400184|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||||95.0|1.07|2.3||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Cumulative Logit Model|Based on fitting a logistic regression model for ordinal response of CGI-S scores at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. The odds of having an increasingly better response for pregabalin relative to the odds of having an increasingly better response for placebo.|Week 8 Last Observation Carried Forward (LOCF)||2.30|1.07|
91508227|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|1.113||0.0991|TWO_SIDED|95.0|-4.06|0.36|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-4.06|0.0991
91508228|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|1.155||0.0389|TWO_SIDED|95.0|-4.71|-0.13|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-4.71|0.0389
91532733|NCT02478359|182942214|SUPERIORITY|||||||0.11||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.11
91532734|NCT02478359|182942215|SUPERIORITY|||||||0.83||||||Adjusted P value|Regression, Linear|||Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.83
91532735|NCT01818700|182942226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|-10.0|10.0|||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||10|-10|<0.05
91532736|NCT01852955|182942232|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
91532737|NCT01852955|182942233|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.04
91532738|NCT01852955|182942234|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.36
91532739|NCT01272011|182942241|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Two-way RMANOVA Student-Newman-Keuls|||Daily acute and cumulative Pre vs Post comparisons||||<0.001
91508229|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-3.48|STANDARD_ERROR_OF_MEAN|1.108||0.0022|TWO_SIDED|95.0|-5.67|-1.28|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.28|-5.67|0.0022
91508230|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.429||0.0255|TWO_SIDED|95.0|-6.08|-0.4|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.40|-6.08|0.0255
91508231|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|1.356||0.1375|TWO_SIDED|95.0|-4.73|0.66|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.66|-4.73|0.1375
91532740|NCT01272011|182942242|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of AF vs. Resistance||||<0.05
91532741|NCT01272011|182942242|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of of Pressure vs. Resistance||||<0.05
91753687|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||||95.0|-1.5|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 1||0.0|-1.5|
91753688|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||||95.0|-1.5|0.2|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 2||0.2|-1.5|
91753689|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||||95.0|-1.6|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 3||0.1|-1.6|
91753690|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||||95.0|-2.1|-0.6|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 4||-0.6|-2.1|
91753691|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-1.3|0.5|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 5||0.5|-1.3|
91753692|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||||95.0|-1.8|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 6||0.0|-1.8|
91753693|NCT00413010|183400185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||||95.0|-2.1|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 8||0.1|-2.1|
91753694|NCT05432167|183400188|SUPERIORITY||Mean Difference (Final Values)|-8.08|STANDARD_ERROR_OF_MEAN|2.676||0.003|TWO_SIDED|95.0|-13.36|-2.79|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.79|-13.36|0.003
91753695|NCT05432167|183400189|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|3.051||0.019|TWO_SIDED|95.0|-13.24|-1.19|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-1.19|-13.24|0.019
91753696|NCT05432167|183400190|SUPERIORITY||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|3.098||0.004|TWO_SIDED|95.0|-15.1|-2.87|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.87|-15.10|0.004
91753697|NCT01511809|183400192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A lower limit of the 95% confidence interval of the difference between the two proportions of treatment failure (triple therapy-monotherapy) below the pre-specified margin of non-inferiority of -10% established inferiority. A sample size of 342 patients (171 per treatment arm) provided 80% power (one-sided, alpha 0.05) to establish non-inferiority of ATV/r monotherapy as compared to ATV/r triple therapy with an overall treatment failure (TF) rate of 15% at week 48.|difference between TF proportions|15.0|||||TWO_SIDED|||||||||"Here are reported the results of the 48-week interim analyses according to the intention-to-treat (ITT) principle. ITT=F (with re-intensification=failure) and the ITT=S (with re-intensification=success) treatment failure results are shown.~Based on the efficacy data review, in June 2013, an independent Data and Safety Monitoring Board (DSMB) recommended to stop further patients' enrolment and to follow-up the enrolled patients until 96 weeks, after having signed an updated informed consent."||||
91753698|NCT00364533|183400206|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|91.4|||<|0.001||95.0|49.77|133.07|||ANCOVA|||The study was terminated and did not reach the planned sample size.||133.07|49.77|<0.001
91753699|NCT00364533|183400206|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|38.66|124.29|||ANCOVA|||The study was terminated and did not reach the planned sample size.||124.29|38.66|<0.001
91753700|NCT00364533|183400206|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|39.21|123.8|||ANCOVA|||The study was terminated and did not reach the planned sample size.||123.80|39.21|<0.001
91753701|NCT00364533|183400206|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|82.4|||<|0.001||95.0|38.96|125.88|||ANCOVA|||The study was terminated and did not reach the planned sample size.||125.88|38.96|<0.001
91753702|NCT00973102|183400236|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.47||||0.252|TWO_SIDED|95.0|1.16|5.25|||Barnard's unconditional Exact Test|||||5.25|1.16|.252
91753703|NCT00973102|183400237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.895|||||||t-test, 2 sided|||||||.895
91753704|NCT02360293|183400240|SUPERIORITY||Slope|1.88|STANDARD_ERROR_OF_MEAN|46.2|||TWO_SIDED|95.0|-119.0|122.7|||||Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.||122.7|-119.0|
91753705|NCT02360293|183400241|SUPERIORITY||Slope|-5.02|STANDARD_ERROR_OF_MEAN|56.7|||TWO_SIDED|95.0|-15.85|5.81|||||Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||5.81|-15.85|
91753706|NCT02360293|183400242|SUPERIORITY||Slope|-1.162|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.969|0.646|||||Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.646|-2.969|
91753707|NCT02360293|183400243|SUPERIORITY||Slope|-0.345|STANDARD_ERROR_OF_MEAN|0.267|||TWO_SIDED|95.0|-1.044|0.353|||||"Estimate generated through ANCOVA predicting Pain In Past Week as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.."|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.353|-1.044|
91753708|NCT02945553|183400256|OTHER|Mixed model analysis of variance|Mean Difference (Final Values)|1596.0|STANDARD_DEVIATION|202.0|<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91753709|NCT02945553|183400261|OTHER||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91753710|NCT02700165|183400295|OTHER||sucess proportion|78.6|||||TWO_SIDED|95.0|49.2|95.3|||||Independent physician reviewers correctly identified 13/14, 11/14 and 10/14, respectively for an overall percentage of correct identification of 34/42 or 81%. Two of three reviewers correctly identified 11/14 (78.6%) photos.|||95.3|49.2|
91753711|NCT01739803|183400299|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||To control for experiment-wise Type I error rate in this analysis, a comparison-wise alpha of 0.01 was used.|Mixed Models Analysis|||We projected mean composite adherence rate for all participants to be approximately 80% ± 15. We anticipated at least 10% increase in intervention group adherence at end of intervention. To have 80% power to detect expected difference of 10% at the 2-tailed 5% significance level, sample size needed to be at least 36 RTRs per group. We took a conservative approach, in combination with anticipated attrition over the course of study, and increased enrollment.||||<0.05
91753712|NCT01739803|183400300|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
91753713|NCT01739803|183400301|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.05||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
91753714|NCT00915148|183400302|SUPERIORITY_OR_OTHER||||||<|0.01||||||The reported p-value corresponds with each area under the ROC assessments|Chi-squared|||In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head - perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.||||<0.01
91753715|NCT00915148|183400303|SUPERIORITY_OR_OTHER||||||<|0.01||||||the reported p-value corresponds with each log rank comparison|Log Rank|||"Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~1. women with fetal head-perineum distance ≤40 mm vs. women with distance \>40 mm measured with 2D ultrasound.~2. women with angle of progression ≥110 degrees vs. women with angle \<110 degrees measured with 2D ultrasound"||||<0.01
91753716|NCT01428336|183400311|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.06|||||TWO_SIDED|95.0|-0.2|0.6||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT||0.60|-0.20|
91508232|NCT02942017|182888943|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.4||0.817|TWO_SIDED|95.0|-3.11|2.46|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.46|-3.11|0.8170
91508233|NCT02942017|182888944|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0168|TWO_SIDED|95.0|1.2|6.7|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.7|1.2|0.0168
91508234|NCT02942017|182888944|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0482|TWO_SIDED|95.0|1.0|6.6|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.6|1.0|0.0482
91508235|NCT02942017|182888944|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5857|TWO_SIDED|95.0|0.3|2.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||2.0|0.3|0.5857
91508236|NCT02942017|182888945|SUPERIORITY||Odds Ratio (OR)|3.4||||0.0033|TWO_SIDED|95.0|1.5|7.9||Hour 60:|GEE method|||Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.9|1.5|0.0033
91508237|NCT02942017|182888945|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0046|TWO_SIDED|95.0|1.5|9.3|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||9.3|1.5|0.0046
91508238|NCT02942017|182888945|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3085|TWO_SIDED|95.0|0.3|1.5|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||1.5|0.3|0.3085
91508239|NCT02942017|182888946|SUPERIORITY||LS mean difference|-8.35|STANDARD_ERROR_OF_MEAN|2.989||0.0063|TWO_SIDED|95.0|-14.29|-2.42|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.42|-14.29|0.0063
91753717|NCT01428336|183400311|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.07|||||TWO_SIDED|95.0|-0.69|-0.01||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT||-0.01|-0.69|
91753718|NCT01428336|183400311|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.06|||||TWO_SIDED|95.0|-0.65|0.04||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT||0.04|-0.65|
91508240|NCT02942017|182888946|SUPERIORITY||LS mean difference|-9.75|STANDARD_ERROR_OF_MEAN|3.566||0.0074|TWO_SIDED|95.0|-16.83|-2.68|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.68|-16.83|0.0074
91508241|NCT02942017|182888946|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|3.149||0.6637|TWO_SIDED|95.0|-4.88|7.63|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||7.63|-4.88|0.6637
91508242|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.5132|TWO_SIDED|95.0|-0.41|0.21|||MMRM|||Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.41|0.5132
91535619|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.54|STANDARD_ERROR_OF_MEAN|2.46||0.0089|TWO_SIDED|95.0|-11.42|-1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.67|-11.42|0.0089
91753719|NCT01428336|183400312|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.12|||||TWO_SIDED|95.0|-0.24|0.65||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol||0.65|-0.24|
91753720|NCT01428336|183400312|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.18|||||TWO_SIDED|95.0|-0.91|-0.15||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol||-0.15|-0.91|
91753721|NCT01428336|183400312|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.19|||||TWO_SIDED|95.0|-0.94|-0.14||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol||-0.14|-0.94|
91753722|NCT02449018|183400316|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.31||0.13|TWO_SIDED|90.0|-0.24|0.79|||ANCOVA|||||0.79|-0.24|0.130
91753723|NCT05011513|183400376|SUPERIORITY|||||||0.6027|||||||Log Rank|||||||0.6027
91753724|NCT05011513|183400378|SUPERIORITY|||||||0.1796||||||P-value reported for COVID-19 hospitalization and death due to any cause.|Normal approximation|||||||0.1796
91753725|NCT05011513|183400380|SUPERIORITY|||||||0.0971|||||||Negative binomial|||||||0.0971
91753726|NCT05011513|183400382|SUPERIORITY||Odds Ratio (OR)|0.819||||0.1622|TWO_SIDED|95.0|0.618|1.084|||Regression, Logistic|||Main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.084|0.618|0.1622
91753727|NCT05011513|183400383|SUPERIORITY|||||||0.4298|||||||Log Rank|||||||0.4298
91753728|NCT05011513|183400386|SUPERIORITY||Odds Ratio (OR)|0.802||||0.1086|TWO_SIDED|95.0|0.613|1.05|||Regression, Logistic|||Main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status (positive/negative), vaccination status (complete/not vaccinated) and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL).||1.050|0.613|0.1086
91753729|NCT05011513|183400387|SUPERIORITY||Odds Ratio (OR)|50.333||||0.3262|TWO_SIDED|95.0|13.163|192.472|||Breslow-Day Test|||||192.472|13.163|0.3262
91753730|NCT05011513|183400387|SUPERIORITY||Odds Ratio (OR)|22.224|||||TWO_SIDED|95.0|8.36|59.08||||||Odds ratio for Day 5 vs Day 1||59.080|8.360|
91753731|NCT01192568|183400418|SUPERIORITY||Mean Difference (Final Values)|14.22|STANDARD_ERROR_OF_MEAN|4.612||0.0928|TWO_SIDED|95.0|-2.45|30.9|||ANCOVA|||||30.90|-2.45|0.0928
91753732|NCT01192568|183400419|SUPERIORITY||Mean Difference (Final Values)|34.92|STANDARD_ERROR_OF_MEAN|8.089||0.0054|TWO_SIDED|95.0|11.13|58.7|||ANCOVA|||||58.70|11.13|0.0054
91753733|NCT01192568|183400420|SUPERIORITY||Mean Difference (Final Values)|32.59|STANDARD_ERROR_OF_MEAN|13.215||0.1739|TWO_SIDED|95.0|-14.89|80.07|||ANCOVA|||||80.07|-14.89|0.1739
91753734|NCT01192568|183400421|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.117||0.266|TWO_SIDED|95.0|-0.53|0.15|||ANCOVA|||Results from a pre-specified test (Kolmogorov-Smirnov test p \<= 0.05) determined that the Pre-Am3 and Post-Am3 OTG data should be analyzed separately for the primary analysis.||0.15|-0.53|0.2660
91753735|NCT01192568|183400421|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.007|TWO_SIDED|95.0|-1.13|-0.21|||t-test, 2 sided|||||-0.21|-1.13|0.0070
91753736|NCT02593825|183400422|SUPERIORITY|Significance was based on α = .05. Hedges' g, corrected for small sample bias, was calculated as a measure of effect size using the model-predicted group differences in rate of change in the numerator and the pooled standard deviation estimated from the 3 or 12 month assessment (for short- and long-term effects, respectively) in the denominator.|Slope|1.14|||<|0.05|TWO_SIDED|||||Piecewise linear mixed modeling (LMM) was performed to address the study questions. LMM was necessary to account for repeated measures nested within children.|Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months) and post-intervention (3 to 12 months) phases, and accounted for variation in the time between assessments across children. All models controlled for intercept-level differences by site, as well as intercept- and slope-level differences by baseline-adjusted age and motor severity. Intervention effects were derived via intervention by slope interaction terms. Three-way interaction terms were subsequently added to the models to obtain intervention effects stratified by severity.|||<0.05
91753737|NCT02593825|183400423|SUPERIORITY||Mean Difference (Final Values)|0.192||||0.05|TWO_SIDED||||||Linear piecewise modeling|||||||.05
91753738|NCT02593825|183400424|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED||||||Mixed Models Analysis||data shown is for the 12 month time point for the severely delayed group comparison|Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)||||<0.05
91753739|NCT02593825|183400426|SUPERIORITY||Slope|1.02|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|LMM was necessary to account for repeated measures nested within children. Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months).|||<0.05
91753740|NCT02593825|183400427|SUPERIORITY||Slope|8.7|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months)|||<0.05
91753741|NCT02593825|183400428|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.417|TWO_SIDED||||||Mixed Models Analysis|||||||0.417
91753742|NCT06359080|183400430|EQUIVALENCE|The difference between post treatment CARS scores and pre treatment CARS scores will be statistically significant as measured by independent sample t-test with p\<.05|Mean Difference (Net)|6.77|STANDARD_DEVIATION|5.5|<|0.05|TWO_SIDED|95.0|5.36|8.19||It's a calculated p-value.|t-test, 2 sided|||||8.19|5.36|<0.05
91753743|NCT00511134|183400439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Descriptive data|||It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.||||<0.05
91753744|NCT00511134|183400440|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Fisher Exact|Degrees of freedom=1||It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.||||<0.05
91753745|NCT03323736|183400498|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.80) exceeded the 68% success rate performance goal.|Credible Interval|0.86|||||TWO_SIDED|95.0|0.8|0.91||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.91|0.80|
91753746|NCT03323736|183400498|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.82) exceeded the 68% success rate performance goal.|Credible Interval|0.89|||||TWO_SIDED|95.0|0.82|0.93||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.93|0.82|
91753747|NCT03323736|183400499|SUPERIORITY|Comparison of mean tube placement FPS-R score to a performance goal of 4.2.||||||0.0072||||||Mean FPS-R score hypothesized to be less than (superior to) a performance goal of 4.2, at a significance level of 0.025 (p\<0.025).|t-test, 1 sided|||||||0.0072
91753748|NCT03323736|183400500|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>80%, at alpha = 0.025.|mid-P method for single proportion|||Tube Patency endpoint would be successfully met if the percentage of subjects with patent tubes was greater than (superior to) 80% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
91753749|NCT03323736|183400501|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>88%, at alpha = 0.025.|mid-P method for single proportion|||Tube Retention endpoint would be successfully met if the percentage of subjects with retained tubes was greater than (superior to) 88% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
91753750|NCT03323736|183400502|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>85%, at alpha = 0.025.|mid-P method for single proportion|||The Anesthesia Effectiveness endpoint would be successfully met if the percentage of subjects with successful anesthesia was greater than (superior to) 85% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
91753751|NCT01885910|183400506|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
91753752|NCT05063539|183400537|SUPERIORITY||Posterior Mean Difference|1.68|||||TWO_SIDED|95.0|-0.375|3.771|||||Posterior mean difference with 95% credible interval is reported.|||3.771|-0.375|
91753753|NCT05063539|183400537|SUPERIORITY||Posterior Mean Difference|-3.2|||||TWO_SIDED|95.0|-5.354|-1.042|||||Posterior mean difference with 95% credible interval is reported.|||-1.042|-5.354|
91753754|NCT05063539|183400538|SUPERIORITY||Posterior Mean Difference|1.59|||||TWO_SIDED|95.0|-0.443|3.697|||||Posterior mean difference with 95% credible interval is reported.|||3.697|-0.443|
91753755|NCT05063539|183400538|SUPERIORITY||Posterior Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.277|-2.862||||||||-2.862|-7.277|
91753756|NCT05063539|183400539|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.32||0.665|TWO_SIDED|95.0|-0.763|0.488|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.488|-0.763|0.665
91753757|NCT05063539|183400539|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|95.0|0.435|1.736|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.736|0.435|0.001
91753758|NCT05063539|183400540|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.35||0.878|TWO_SIDED|95.0|-0.641|0.749|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.749|-0.641|0.878
91753759|NCT05063539|183400540|SUPERIORITY||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.615|2.05|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.050|0.615|<0.001
91753760|NCT05063539|183400541|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.99||0.252|TWO_SIDED|95.0|-3.073|0.811|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.811|-3.073|0.252
91753761|NCT05063539|183400541|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.03||0.825|TWO_SIDED|95.0|-2.252|1.797|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.797|-2.252|0.825
91753762|NCT05063539|183400542|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.09||0.733|TWO_SIDED|95.0|-2.527|1.779|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.779|-2.527|0.733
91753763|NCT05063539|183400542|SUPERIORITY||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.13||0.143|TWO_SIDED|95.0|-0.565|3.877|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||3.877|-0.565|0.143
91753764|NCT05063539|183400543|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.0||0.86|TWO_SIDED|95.0|-1.802|2.158|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.158|-1.802|0.860
91753765|NCT05063539|183400543|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_ERROR_OF_MEAN|1.04||0.017|TWO_SIDED|95.0|-4.567|-0.456|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.456|-4.567|0.017
91753766|NCT05063539|183400544|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.1||0.479|TWO_SIDED|95.0|-2.949|1.387|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.387|-2.949|0.479
91753767|NCT05063539|183400544|SUPERIORITY||LS Mean Difference|-4.01|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-6.239|-1.788|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-1.788|-6.239|<0.001
91753768|NCT05063539|183400545|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.53||0.259|TWO_SIDED|95.0|-0.445|1.642|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.642|-0.445|0.259
91508243|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.181||0.1672|TWO_SIDED|95.0|-0.61|0.11|||MMRM|||Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.61|0.1672
91508244|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.178||0.0963|TWO_SIDED|95.0|-0.65|0.05|||MMRM|||Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.65|0.0963
91753769|NCT05063539|183400545|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.55||0.324|TWO_SIDED|95.0|-1.629|0.541|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.541|-1.629|0.324
91753770|NCT05063539|183400546|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.57||0.749|TWO_SIDED|95.0|-0.946|1.313|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.313|-0.946|0.749
91753771|NCT05063539|183400546|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.029|TWO_SIDED|95.0|-2.462|-0.134|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.134|-2.462|0.029
91753772|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.012||0.346|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Frontal||0.03|-0.01|0.346
91753773|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.412|TWO_SIDED|95.0|-0.04|0.01|||ANCOVA|||Frontal||0.01|-0.04|0.412
91753774|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Parietal||0.02|-0.04|0.421
91753775|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.014||0.08|TWO_SIDED|95.0|-0.05|0.0|||ANCOVA|||Parietal||0.00|-0.05|0.080
91753776|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.021||0.192|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA|||Lateral occipital||0.01|-0.07|0.192
91753777|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.279|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||Lateral occipital||0.02|-0.07|0.279
91753778|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.016||0.693|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Lateral temporal||0.02|-0.04|0.693
91753779|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.04|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA|||Lateral temporal||-0.00|-0.07|0.040
91753780|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.838|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.03|-0.03|0.838
91753781|NCT05063539|183400547|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.055|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.00|-0.06|0.055
91753782|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.455|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Frontal||0.04|-0.02|0.455
91753783|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.745|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA|||Frontal||0.02|-0.03|0.745
91753784|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.015||0.676|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Parietal||0.04|-0.02|0.676
91753785|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.794|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||Parietal||0.03|-0.03|0.794
91753786|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.643|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Lateral occipital||0.03|-0.05|0.643
91753787|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.021||0.88|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Lateral occipital||0.04|-0.05|0.880
91753788|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.844|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Lateral temporal||0.03|-0.04|0.844
91753789|NCT05063539|183400548|SUPERIORITY|Lateral temporal|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.388|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.388
91753790|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.016||0.815|TWO_SIDED|95.0|-0.03|0.04|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.04|-0.03|0.815
91753791|NCT05063539|183400548|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.562|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.02|-0.04|0.562
91753792|NCT05063539|183400549|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.024|<|0.001|TWO_SIDED|95.0|0.04|0.14|||Mixed Models Analysis|||Bilateral Hippocampus||0.14|0.04|<0.001
91753793|NCT05063539|183400549|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||Bilateral Hippocampus||0.18|0.08|<0.001
91753794|NCT05063539|183400549|SUPERIORITY||LS Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-3.53|-1.21|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.21|-3.53|<0.001
91753795|NCT05063539|183400549|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.611||0.008|TWO_SIDED|95.0|-2.84|-0.43|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.43|-2.84|0.008
91753796|NCT05063539|183400549|SUPERIORITY||LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|1.715|<|0.001|TWO_SIDED|95.0|4.79|11.56|||Mixed Models Analysis|||Bilateral Whole Brain||11.56|4.79|<0.001
91753797|NCT05063539|183400549|SUPERIORITY||LS Mean Difference|9.37|STANDARD_ERROR_OF_MEAN|1.804|<|0.001|TWO_SIDED|95.0|5.81|12.92|||Mixed Models Analysis|||Bilateral Whole Brain||12.92|5.81|<0.001
91753798|NCT05063539|183400550|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.04|0.13|||Mixed Models Analysis|||Bilateral Hippocampus||0.13|0.04|<0.001
91753799|NCT05063539|183400550|SUPERIORITY|Bilateral Hippocampus|LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.08|0.17|||Mixed Models Analysis|||||0.17|0.08|<0.001
91753800|NCT05063539|183400550|SUPERIORITY||LS Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.33|-1.08|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.08|-3.33|<0.001
91753801|NCT05063539|183400550|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.582||0.015|TWO_SIDED|95.0|-2.57|-0.28|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.28|-2.57|0.015
91753802|NCT05063539|183400550|SUPERIORITY||LS Mean Difference|7.17|STANDARD_ERROR_OF_MEAN|1.635|<|0.001|TWO_SIDED|95.0|3.95|10.4|||Mixed Models Analysis|||Bilateral Whole Brain||10.40|3.95|<0.001
91753803|NCT05063539|183400550|SUPERIORITY||LS Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|4.85|11.47|||Mixed Models Analysis|||Bilateral Whole Brain||11.47|4.85|<0.001
91753804|NCT02262078|183400553|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
91753805|NCT04692077|183400554|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Reported Grade 2 and Above AEs|99.7|51.8|
91508245|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.183||0.4803|TWO_SIDED|95.0|-0.49|0.23|||MMRM|||Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.49|0.4803
91508246|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.191||0.0844|TWO_SIDED|95.0|-0.71|0.05|||MMRM|||Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.71|0.0844
91508247|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.193||0.1325|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1325
91508248|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.192||0.0332|TWO_SIDED|95.0|-0.79|-0.03|||MMRM|||Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.79|0.0332
91508249|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.189||0.1273|TWO_SIDED|95.0|-0.67|0.08|||MMRM|||Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.67|0.1273
91753806|NCT04692077|183400555|OTHER||Exact CI for Proportions|11.1|||||TWO_SIDED|95.0|0.3|48.3|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|48.3|0.3|
91508250|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.182||0.1059|TWO_SIDED|95.0|-0.66|0.06|||MMRM|||Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.66|0.1059
91753807|NCT04692077|183400556|OTHER||Exact CI for Proportions|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|95.7|22.3|
91753808|NCT04692077|183400560|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase.|99.7|51.8|
91508251|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.215||0.0683|TWO_SIDED|95.0|-0.82|0.03|||MMRM|||Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.82|0.0683
91508252|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4458|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4458
91753809|NCT04692077|183400561|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Completed All Scheduled Injections among those who received at least one Injection|99.7|51.8|
91753810|NCT04271475|183400595|SUPERIORITY||Least square mean|-16.1|STANDARD_ERROR_OF_MEAN|8.2||0.974|TWO_SIDED|95.0|-32.34|0.16|||MMRM||Least square mean and SE of the mean was estimated by mixed model repeated measurements method.|||0.16|-32.34|0.974
91508253|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.228||0.2905|TWO_SIDED|95.0|-0.21|0.7|||MMRM|||Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.70|-0.21|0.2905
91508254|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.182||0.3096|TWO_SIDED|95.0|-0.18|0.55|||MMRM|||Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.18|0.3096
91753811|NCT00300677|183400612|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
91753812|NCT00300677|183400612|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
91753813|NCT00300677|183400613|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of the adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
91753814|NCT00300677|183400613|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
91753815|NCT00300677|183400614|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
91753816|NCT00300677|183400614|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
91753817|NCT00300677|183400615|SUPERIORITY_OR_OTHER||predose: ratio adjusted mean|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plama (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
91508255|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.165||0.1925|TWO_SIDED|95.0|-0.55|0.11|||MMRM|||Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.55|0.1925
91508256|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.168||0.0101|TWO_SIDED|95.0|-0.77|-0.11|||MMRM|||Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.77|0.0101
91508257|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.1546|TWO_SIDED|95.0|-0.56|0.09|||MMRM|||Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.56|0.1546
91753818|NCT00300677|183400615|SUPERIORITY_OR_OTHER||postdose: ratio adjusted mean|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
91508258|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.168||0.0901|TWO_SIDED|95.0|-0.62|0.05|||MMRM|||Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.62|0.0901
91753819|NCT01300351|183400616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.078|TWO_SIDED|95.0|0.54|1.03||With a sample size of 220 randomised patients and 150 progression events, if treatment effect is consistent between ethnicities/the study populations, there is an 89% chance the HR \<1.|Log Rank|||The results of this study would be considered to be consistent with that of the CONFIRM study if the hazard ratio (HR) point estimate for the treatment comparison was \<1 (ie, it favoured fulvestrant 500 mg), without the requirement for the benefit of fulvestrant 500 mg to be statistically significant.||1.03|0.54|0.078
91753820|NCT01300351|183400617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.107|TWO_SIDED|95.0|0.93|2.24|||Regression, Logistic|||||2.24|0.93|0.107
91508259|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.162||0.0717|TWO_SIDED|95.0|-0.62|0.03|||MMRM|||Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.62|0.0717
91532742|NCT02240680|182942248|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.81|-0.46|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-0.46|-0.81|< 0.0001
91753821|NCT01300351|183400618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.023|TWO_SIDED|95.0|1.04|1.8|||Regression, Logistic|||||1.80|1.04|0.023
91753822|NCT00673881|183400652|SUPERIORITY_OR_OTHER|||||||0.0042||95.0|||||t-test, 2 sided|||||||0.0042
91753823|NCT00673881|183400653|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||Comparison baseline to end-of-treatment||||0.0002
91753824|NCT00673881|183400654|SUPERIORITY_OR_OTHER||||||NS|0|||||||t-test, 2 sided|||Comparison from baseline to end-of-treatment||||NS
91753825|NCT00673881|183400662|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91753826|NCT01189292|183400687|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.0||||0.001|TWO_SIDED|95.0|12.0|42.0|||Chi-squared|||null hypothesis: Incidence of PONV is the same in both treatment arms||42|12|0.001
91753827|NCT01189292|183400688|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.0||||0.006|TWO_SIDED|95.0|7.0|40.0|||Chi-squared|||per protocol analysis||40|7|0.006
91753828|NCT01189292|183400691|SUPERIORITY_OR_OTHER|||||||0.674|TWO_SIDED||||||Mixed Models Analysis|mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)||||||0.674
91532743|NCT02240680|182942249|OTHER||Odds Ratio (OR)|1.464|STANDARD_ERROR_OF_MEAN|0.397||0.1594|TWO_SIDED|95.0|0.861|2.491|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For any hypoglycemia event accompanied by prespecified glucose value||2.491|0.861|0.1594
91753829|NCT01189292|183400692|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.835
91753830|NCT01173029|183400710|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|1.7||||0.19|TWO_SIDED|95.0|0.7|4.1||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' tests Yates's corrected Chi-squared or Fisher's exact test, when appropriate Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||4.1|0.7|0.19
91753831|NCT01173029|183400711|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|2.6||||0.01|TWO_SIDED|95.0|1.01|7.3||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' test Yates' corrected Chi-squared or Fisher's exact test Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||7.3|1.01|0.01
91753832|NCT01173029|183400711|NON_INFERIORITY_OR_EQUIVALENCE|Proportional-risk hypothesis was tested using the correlation between Schoenfeld's residuals and time (Schoenfeld's global test). The correlation rho was -0.08, Chi-squared was 0.12, and p was 0.73. Therefore, the hypothesis of proportional risk was accepted, validating the correct application model.|Hazard Ratio (HR)|2.2||||0.04|TWO_SIDED|95.0|1.1|4.8||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic groups|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for both groups.||Cox proportional hazard model for the composite endpoint (stroke + myocardial infarction) was assessed. By taking pseudo-resistant arterial hypertension as baseline reference, the hazard ratio for the composite endpoint was calculated.||4.8|1.1|0.04
91753833|NCT01173029|183400712|SUPERIORITY_OR_OTHER||C-statistic|0.66|||<|0.01|TWO_SIDED|95.0|0.56|0.76||At an optimal value of \>3, polygenic risk score yielded 90% sensitivity and 40% specificity for composite endpoint.|z test|Area under receiver operating characteristic curve.|The optimal cutoff value for polygenic risk score was set to \>3.|Receiver operating characteristic curve analysis for the polygenic score as predictor of composite endpoint (stroke + myocardial infarction)||0.76|0.56|<0.01
91753834|NCT01173029|183400712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.9||||0.04|TWO_SIDED|95.0|1.2|9.2||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic group|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for polygenic risk score\<=3 and \>3.||Cox proportional hazard model of the polygenic risk score\<=3 and \> 3 for the composite endpoint (stroke + myocardial infarction). By taking polygenic risk score\<=3, the hazard ratio for the composite endpoint was calculated for polygenic risk score\>3 .||9.2|1.2|0.04
91753835|NCT01842581|183400714|NON_INFERIORITY|Threshold for significance=upper bound of the 2-sided 95% confidence interval (CI) for hazard ratio less than (\<) 1.56.|Hazard Ratio (HR)|1.959||||0.0359|TWO_SIDED|95.0|1.045|3.672|||Score statistics|||Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.672|1.045|0.0359
91753836|NCT01842581|183400715|SUPERIORITY|2-sided test at a significance level of 0.05.|Hazard Ratio (HR)|1.739||||0.0985|TWO_SIDED|95.0|0.894|3.382||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by analysis region. Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.382|0.894|0.0985
91753837|NCT03973905|183400722|OTHER||Vaccine Effectiveness|65.26|||||TWO_SIDED|95.0|-64.93|92.68|||||Vaccine Effectiveness (VE) was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy (at least 14 days before delivery) at preventing pertussis in infants \<2 months||92.68|-64.93|
91753838|NCT03973905|183400723|OTHER||Vaccine Effectiveness|42.01|||||TWO_SIDED|95.0|-1071.8|97.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||97.13|-1071.80|
91753839|NCT03973905|183400723|OTHER||Vaccine Effectiveness|62.17|||||TWO_SIDED|95.0|-439.75|97.35|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during first or second trimester of pregnancy at preventing pertussis in infants \<2 months||97.35|-439.75|
91753840|NCT03973905|183400723|OTHER||Vaccine Effectiveness|-12.89|||||TWO_SIDED|95.0|-166.37|52.16|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||52.16|-166.37|
91753841|NCT03973905|183400724|OTHER||Vaccine Effectiveness|64.79|||||TWO_SIDED|95.0|-57.51|92.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix at any time during pregnancy at preventing pertussis in infants \<2 months||92.13|-57.51|
91753842|NCT03973905|183400725|OTHER||Vaccine Effectiveness|17.65|||||TWO_SIDED|95.0|-12529.0|99.46|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||99.46|-12529.0|
91753843|NCT03973905|183400725|OTHER||Vaccine Effectiveness|85.01|||||TWO_SIDED|95.0|-13.91|98.03|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy at preventing pertussis in infants \<2 months||98.03|-13.91|
91532744|NCT02240680|182942249|OTHER||Odds Ratio (OR)|1.149|STANDARD_ERROR_OF_MEAN|0.377||0.672|TWO_SIDED|95.0|0.604|2.188|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For glucose value \< 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia||2.188|0.604|0.6720
91753844|NCT03973905|183400725|OTHER||Vaccine Effectiveness|37.64|||||TWO_SIDED|95.0|-87.4|79.25|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||79.25|-87.40|
91508260|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.169||0.0468|TWO_SIDED|95.0|-0.68|0.0|||MMRM|||Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.68|0.0468
91508261|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.173||0.2222|TWO_SIDED|95.0|-0.56|0.13|||MMRM|||Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.56|0.2222
91508262|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.156||0.0682|TWO_SIDED|95.0|-0.6|0.02|||MMRM|||Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.60|0.0682
91508263|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0147|TWO_SIDED|95.0|-0.72|-0.08|||MMRM|||Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.72|0.0147
91508264|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.182||0.0837|TWO_SIDED|95.0|-0.68|0.04|||MMRM|||Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.68|0.0837
91508265|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.179||0.5828|TWO_SIDED|95.0|-0.46|0.26|||MMRM|||Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.46|0.5828
91532745|NCT02240680|182942250|OTHER||Odds Ratio (OR)|5.018|STANDARD_ERROR_OF_MEAN|1.818|<|0.0001|TWO_SIDED|95.0|2.468|10.206|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||10.206|2.468|< 0.0001
91753845|NCT02553538|183400726|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91753846|NCT02553538|183400727|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
91753847|NCT02553538|183400728|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
91753848|NCT02553538|183400729|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91753849|NCT02648217|183400730|SUPERIORITY_OR_OTHER||Treatment Contrast|0.02||||0.8426|TWO_SIDED|95.0|-0.2|0.24|||Mixed model for repeated measurements|||The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model.||0.24|-0.20|0.8426
91753850|NCT00357656|183400737|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority by the 200% margin of non-inferiority was demonstrated if the upper confidence limit of a 95% 2-sided confidence interval for the ratio of means did not exceed 200%.|Mean ratio CI/BI|0.924||||0.001|TWO_SIDED|95.0|0.816|1.046||one-sided p-value against the null hypothesis of ration \>=200%|Hypothesis test|||The main analysis used a point estimate and a two-sided 95% confidence interval for ratio of the primary outcome measure of CI over BI combined over the three strata: stratum A: unilateral knee replacement, stratum B: hip surgery, stratum C: shoulder/elbow/ankle/knee (except knee replacement) surgery.||1.046|0.816|0.001
91753851|NCT00815191|183400752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority delta of 0.5°C|Mean Difference (Final Values)|0.091|||<|0.0001|TWO_SIDED|95.0|-0.139|0.321|||ANOVA|Repeated measures ANOVA||||0.321|-0.139|<0.0001
91753852|NCT01741532|183400756|SUPERIORITY|||||||0.0761|||||||Mixed Models Analysis|||||||0.0761
91753853|NCT01741532|183400757|SUPERIORITY|||||||0.7279|||||||Mixed Models Analysis|||||||0.7279
91753854|NCT01741532|183400758|SUPERIORITY|||||||0.7228|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part I||||0.7228
91753855|NCT01741532|183400758|SUPERIORITY|||||||0.3677|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part II||||0.3677
91753856|NCT01741532|183400758|SUPERIORITY|||||||0.2182|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part III||||0.2182
91753857|NCT01741532|183400758|SUPERIORITY|||||||0.1749|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part VI||||0.1749
91753858|NCT01741532|183400759|SUPERIORITY|||||||0.1524|||||||Mixed Models Analysis|||||||0.1524
91753859|NCT01741532|183400760|SUPERIORITY|||||||0.2026|||||||Mixed Models Analysis|||||||0.2026
91753860|NCT01741532|183400761|SUPERIORITY|||||||0.9759|||||||Mixed Models Analysis|||Patient self-report, total score||||0.9759
91508266|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.168||0.5674|TWO_SIDED|95.0|-0.43|0.24|||MMRM|||Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.43|0.5674
91508267|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.145||0.4613|TWO_SIDED|95.0|-0.18|0.4|||MMRM|||Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.18|0.4613
91508268|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.324|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3240
91508269|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.3023|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3023
91532746|NCT02240680|182942251|OTHER||Odds Ratio (OR)|4.689|STANDARD_ERROR_OF_MEAN|1.519|<|0.0001|TWO_SIDED|95.0|2.485|8.848|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||8.848|2.485|< 0.0001
91753861|NCT01741532|183400761|SUPERIORITY|||||||0.5781|||||||Mixed Models Analysis|||Parent proxy-report, total score||||0.5781
91753862|NCT01741532|183400762|SUPERIORITY|||||||0.6323|||||||Mixed Models Analysis|||||||0.6323
91753863|NCT01741532|183400763|SUPERIORITY|||||||0|||||||Mixed Models Analysis|||||||0.0000
91753864|NCT00613080|183400764|SUPERIORITY_OR_OTHER||Proportion (reported as percentage)|51.0||||0.93|TWO_SIDED||||||Chi-squared|||This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.||||0.93
91753865|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance between baseline and 24 month follow-up;||||0.025
91753866|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
91753867|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
91753868|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance from baseline to 24 month follow-up;||||0.025
91753869|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.747
91753870|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
91753871|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
91753872|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional-FDI comparison between G1G2 and G3G4 and G5G6 Arms success rate from baseline to 24 month recall. For Esthetic and Biological-FDI comparison p values were \> 0.05. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
91753873|NCT02698371|183400830|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms retention rate from baseline to 24 month recall. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
91753874|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
91508270|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.4127|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.4127
91508271|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.2819|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2819
91753875|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
91753876|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
91753877|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
91753878|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.154|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.154
91753879|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
91753880|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
91753881|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
91753882|NCT02698371|183400831|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
91753883|NCT02698371|183400832|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Esthetic of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Esthetic outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
91753884|NCT02698371|183400832|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Functional outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
91753885|NCT02698371|183400832|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.998||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Biologic FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Biological outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||0.998
91508272|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3884|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3884
91753886|NCT02698371|183400833|EQUIVALENCE|alpha value of 0.05 was considered||||||0.029||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Luster Performance at 24 Month Follow-up recall.||||0.029
91508273|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.275|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2750
91753887|NCT02698371|183400833|EQUIVALENCE|alpha value of 0.05 was considered||||||0.002||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall;||||0.002
91508274|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.082||0.1811|TWO_SIDED|95.0|-0.27|0.05|||MMRM|||Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.27|0.1811
91508275|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3854|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3854
91508276|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3822|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3822
91508277|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.082||0.9255|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.9255
91508278|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.091||0.6714|TWO_SIDED|95.0|-0.14|0.22|||MMRM|||Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.14|0.6714
91508279|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.091||0.9838|TWO_SIDED|95.0|-0.18|0.18|||MMRM|||Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.18|0.9838
91508280|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.083||0.8884|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.8884
91508281|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.6996|TWO_SIDED|95.0|-0.23|0.16|||MMRM|||Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.23|0.6996
91508282|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4426|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4426
91753888|NCT02698371|183400833|EQUIVALENCE|alpha value of 0.05 was considered||||||0.618||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall.||||0.618
91508283|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.8743|TWO_SIDED|95.0|-0.2|0.24|||MMRM|||Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.20|0.8743
91508284|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3498|TWO_SIDED|95.0|-0.12|0.35|||MMRM|||Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.12|0.3498
91508285|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.151||0.0839|TWO_SIDED|95.0|-0.56|0.04|||MMRM|||Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.56|0.0839
91753889|NCT02698371|183400834|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.009||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.009
91508286|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.157||0.2595|TWO_SIDED|95.0|-0.49|0.13|||MMRM|||Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.49|0.2595
91508287|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.168||0.056|TWO_SIDED|95.0|-0.66|0.01|||MMRM|||Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.66|0.0560
91508288|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6187|TWO_SIDED|95.0|-0.45|0.27|||MMRM|||Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.45|0.6187
91508289|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.163||0.0187|TWO_SIDED|95.0|-0.72|-0.07|||MMRM|||Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.72|0.0187
91532747|NCT02240680|182942252|OTHER||Odds Ratio (OR)|3.731|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|2.302|6.048|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||6.048|2.302|< 0.0001
91532748|NCT02240680|182942253|SUPERIORITY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|4.8||0.0178|TWO_SIDED|95.0|-21.0|-2.0|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-2.0|-21.0|0.0178
91532749|NCT01657032|182942254|NON_INFERIORITY_OR_EQUIVALENCE|The differences between the study groups were considered significant when the P value was \<0.05.||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91532750|NCT03633903|182942265|SUPERIORITY||Mean Difference (Final Values)|1.04|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This applies to the change from row 1 to row 3 (e.g., baseline pre TSST-C versus follow-up timepoint pre TSST-C)"|Mixed Models Analysis|||||||<.05
91532751|NCT03633903|182942265|SUPERIORITY||Mean Difference (Final Values)|0.77|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This is for the difference from row 1 to row 2 (baseline pre versus baseline post TSST-C)"|Mixed Models Analysis|||||||<.05
91532752|NCT03633903|182942265|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.4|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~Comparing row 1 and row 4 (baseline pre TSST-C versus follow-up post TSST-C)."|Mixed Models Analysis|||||||0.40
91532753|NCT03633903|182942266|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.39|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (CRP biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.39
91532754|NCT03633903|182942266|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.95|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (IL-6 biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.95
91532755|NCT03633903|182942267|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.08|TWO_SIDED|||||the calculated p value.|Mixed Models Analysis|||Comparing group differences (symptoms of anxiety/depression) in mindfulness versus control at baseline versus follow-up timepoints.||||.08
91532756|NCT02987829|182942268|OTHER|||||||||||||||||Determination of the maximum tolerated dose.|One dose limiting toxicity occurred at 320 mg daily of grade 3 QTc prolongation therefore the 280 mg dose was determined to be the maximum tolerated dose and selected as the phase 2 dose.|||
91508290|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.1531|TWO_SIDED|95.0|-0.62|0.1|||MMRM|||Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.62|0.1531
91753890|NCT02698371|183400834|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.059||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.059
91753891|NCT02698371|183400834|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.829||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Staining Margin performance at 24 month follow-up recall.||||0.829
91753892|NCT02698371|183400835|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) Colour Stability-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
91753893|NCT02698371|183400835|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
91753894|NCT02698371|183400835|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.064||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||0.064
91753895|NCT02698371|183400836|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.006||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.006
91753896|NCT02698371|183400836|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.020
91753897|NCT02698371|183400836|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.054||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.054
91753898|NCT02698371|183400837|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.01||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.010
91753899|NCT02698371|183400837|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.071||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.071
91753900|NCT02698371|183400837|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.898||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.898
91753901|NCT02698371|183400838|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.317
91753902|NCT02698371|183400838|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.180
91508291|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.197||0.3341|TWO_SIDED|95.0|-0.58|0.2|||MMRM|||Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.58|0.3341
91508292|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.216||0.8969|TWO_SIDED|95.0|-0.4|0.46|||MMRM|||Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.40|0.8969
91508293|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.174||0.5862|TWO_SIDED|95.0|-0.25|0.44|||MMRM|||Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.25|0.5862
91508294|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.117||0.3776|TWO_SIDED|95.0|-0.13|0.34|||MMRM|||Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.13|0.3776
91508295|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9029|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.9029
91753903|NCT02698371|183400838|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.918
91532757|NCT02531438|182942282|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-1.6|||||TWO_SIDED|95.0|-7.1|3.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||3.8|-7.1|
91532758|NCT02531438|182942283|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-2.4|7.4|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||7.4|-2.4|
91753904|NCT02698371|183400839|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.317
91753905|NCT02698371|183400839|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||.317
91753906|NCT02698371|183400839|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.575||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion \& Abfraction-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.575
91753907|NCT02698371|183400840|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.020
91753908|NCT02698371|183400840|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.107||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.107
91532759|NCT02531438|182942284|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-1.7|6.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||6.8|-1.7|
91508296|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.121||0.6173|TWO_SIDED|95.0|-0.18|0.3|||MMRM|||Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.18|0.6173
91753909|NCT02698371|183400840|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.592||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.592
91753910|NCT02698371|183400841|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
91753911|NCT02698371|183400841|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
91753912|NCT02698371|183400841|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
91508297|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.124||0.2433|TWO_SIDED|95.0|-0.1|0.39|||MMRM|||Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.10|0.2433
91508298|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.139||0.0234|TWO_SIDED|95.0|-0.59|-0.04|||MMRM|||Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.59|0.0234
91508299|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.139||0.054|TWO_SIDED|95.0|-0.55|0.0|||MMRM|||Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.55|0.0540
91508300|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.144||0.0406|TWO_SIDED|95.0|-0.58|-0.01|||MMRM|||Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.58|0.0406
91508301|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.132||0.0295|TWO_SIDED|95.0|-0.56|-0.03|||MMRM|||Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.56|0.0295
91508302|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.0925|TWO_SIDED|95.0|-0.5|0.04|||MMRM|||Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.50|0.0925
91508303|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.152||0.1631|TWO_SIDED|95.0|-0.52|0.09|||MMRM|||Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.52|0.1631
91508304|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.185||0.2213|TWO_SIDED|95.0|-0.6|0.14|||MMRM|||Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.60|0.2213
91508305|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.189||0.9175|TWO_SIDED|95.0|-0.36|0.39|||MMRM|||Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.36|0.9175
91508306|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.165||0.6763|TWO_SIDED|95.0|-0.4|0.26|||MMRM|||Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.40|0.6763
91508307|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.121||0.3805|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3805
91508308|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.127||0.6073|TWO_SIDED|95.0|-0.19|0.32|||MMRM|||Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.19|0.6073
91532760|NCT01813422|182942285|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-1.007|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.375|-0.64|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.|Treatment difference uses placebo as the reference.|||-0.640|-1.375|< 0.0001
91753913|NCT02698371|183400842|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.011||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.011
91753914|NCT02698371|183400842|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.034||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.034
91753915|NCT02698371|183400842|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.885||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.885
91753916|NCT02698371|183400843|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||1.000
91753917|NCT02698371|183400843|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.317
91753918|NCT02698371|183400843|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.403||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.403
91753919|NCT02698371|183400844|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
91753920|NCT02698371|183400844|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
91753921|NCT02698371|183400844|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.04||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.040
91753922|NCT02698371|183400845|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
91753923|NCT02698371|183400845|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
91753924|NCT02698371|183400845|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.211||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||0.211
91753925|NCT02698371|183400846|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.102||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.102
91508309|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.119||0.7848|TWO_SIDED|95.0|-0.27|0.2|||MMRM|||Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.27|0.7848
91532761|NCT01813422|182942286|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-4.889|STANDARD_ERROR_OF_MEAN|1.201|<|0.0001|TWO_SIDED|95.0|-7.247|-2.531|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.|Treatment difference uses placebo as the reference.|||-2.531|-7.247|< 0.0001
91508310|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9038|TWO_SIDED|95.0|-0.25|0.23|||MMRM|||Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.25|0.9038
91508311|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.134|STANDARD_ERROR_OF_MEAN|0.134||0.6869|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6869
91508312|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.139||0.9272|TWO_SIDED|95.0|-0.26|0.29|||MMRM|||Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.26|0.9272
91753926|NCT02698371|183400846|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.180
91508313|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.6931|TWO_SIDED|95.0|-0.31|0.21|||MMRM|||Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.31|0.6931
91508314|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.132||0.8262|TWO_SIDED|95.0|-0.29|0.23|||MMRM|||Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.29|0.8262
91532762|NCT01813422|182942287|SUPERIORITY_OR_OTHER||Treatment Difference|17.0|||<|0.0001|TWO_SIDED|95.0|10.3|23.5|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||23.5|10.3|< 0.0001
91753927|NCT02698371|183400846|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.99||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.990
91532763|NCT01813422|182942288|SUPERIORITY_OR_OTHER||Treatment Difference|12.5||||0.0002|TWO_SIDED|95.0|5.8|19.1|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||19.1|5.8|0.0002
91508315|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.141||0.0749|TWO_SIDED|95.0|-0.54|0.03|||MMRM|||Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.54|0.0749
91508316|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.135||0.1923|TWO_SIDED|95.0|-0.45|0.09|||MMRM|||Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.45|0.1923
91508317|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.176||0.0326|TWO_SIDED|95.0|-0.73|-0.03|||MMRM|||Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.73|0.0326
91508318|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.444|TWO_SIDED|95.0|-0.47|0.21|||MMRM|||Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.47|0.4440
91508319|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.134||0.7057|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7057
91508320|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.137||0.2865|TWO_SIDED|95.0|-0.42|0.13|||MMRM|||Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.42|0.2865
91508321|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9475|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9475
91532764|NCT00483262|182942303|SUPERIORITY_OR_OTHER||>= grade 3 adverse event proportion|0.9|||||TWO_SIDED|90.0|0.72|0.98|||||Estimated proportion of patients with a adverse event of grade 3 or higher.|Single Arm Study||.98|.72|
91508322|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.185||0.188|TWO_SIDED|95.0|-0.61|0.12|||MMRM|||Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.61|0.1880
91753928|NCT02698371|183400847|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.157||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.157
91508323|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.595|TWO_SIDED|95.0|-0.51|0.29|||MMRM|||Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.51|0.5950
91753929|NCT02698371|183400847|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.317
91508324|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.9636|TWO_SIDED|95.0|-0.39|0.41|||MMRM|||Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-0.39|0.9636
91508325|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.196||0.5836|TWO_SIDED|95.0|-0.5|0.28|||MMRM|||Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.50|0.5836
91508326|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.184||0.1568|TWO_SIDED|95.0|-0.63|0.1|||MMRM|||Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.63|0.1568
91753930|NCT02698371|183400847|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.334||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.334
91753931|NCT02698371|183400848|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.132||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.132
91508327|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.177||0.0155|TWO_SIDED|5.0|-0.79|-0.09|||Wilcoxon (Mann-Whitney)|||Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.79|0.0155
91508328|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.192||0.0504|TWO_SIDED|95.0|-0.76|0.0|||MMRM|||Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.76|0.0504
91508329|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.212||0.1865|TWO_SIDED|95.0|-0.7|0.14|||MMRM|||Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.70|0.1865
91753932|NCT02698371|183400848|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.257||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.257
91753933|NCT02698371|183400848|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.918
91753934|NCT01274611|183400853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|0.8|||<|0.01|||||||t-test, 2 sided|||||||<0.01
91753935|NCT01274611|183400854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|15.0|||>|0.01|||||||t-test, 2 sided|||||||>0.01
91753936|NCT00897390|183400876|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.042|||||TWO_SIDED|90.0|1.009|1.075||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.075|1.009|
91508330|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.22||0.0518|TWO_SIDED|95.0|-0.87|0.0|||MMRM|||Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.87|0.0518
91508331|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.239||0.833|TWO_SIDED|95.0|-0.42|0.53|||MMRM|||Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.42|0.8330
91508332|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.191||0.844|TWO_SIDED|95.0|-0.34|0.42|||MMRM|||Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.34|0.8440
91753937|NCT00897390|183400876|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.988|||||TWO_SIDED|90.0|0.958|1.019||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.019|0.958|
91753938|NCT00897390|183400878|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.045|||||TWO_SIDED|90.0|1.013|1.077||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.077|1.013|
91759529|NCT02391363|183411780|SUPERIORITY|||||||0.54||||||Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.54
91753939|NCT00897390|183400878|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.992|||||TWO_SIDED|90.0|0.962|1.022||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.022|0.962|
91508333|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4602|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4602
91532765|NCT00483262|182942303|SUPERIORITY_OR_OTHER||toxicity grade >=3 proportion|0.79|||||TWO_SIDED|90.0|0.66|0.89|||||No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.|Phase II toxicity||.89|.66|
91532766|NCT00483262|182942304|SUPERIORITY_OR_OTHER||response rate of PR or better|0.1|||||TWO_SIDED|90.0|0.02|0.28|||||Response of PR or better|Phase I part of this phase I/II study||.28|.02|
91532767|NCT00483262|182942304|SUPERIORITY_OR_OTHER||response rate of PR or better|0.33|||||TWO_SIDED|90.0|0.21|0.47|||||Response of PR or better|Phase II part of this phase I/II study.||0.47|0.21|
91508334|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.117||0.0891|TWO_SIDED|95.0|-0.03|0.43|||MMRM|||Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.03|0.0891
91508335|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.117||0.3088|TWO_SIDED|95.0|-0.11|0.35|||MMRM|||Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.11|0.3088
91753940|NCT00897390|183400879|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.077|||||TWO_SIDED|90.0|0.978|1.185||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.185|0.978|
91759530|NCT00799266|183411781|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.414||||0.0392|TWO_SIDED|95.0|0.022|0.806|||ANCOVA|||Lumbar Spine BMD Z-score at Month 12||0.806|0.022|0.0392
91759531|NCT00799266|183411782|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.29||||0.1322|TWO_SIDED|95.0|-0.094|0.673|||ANCOVA|||Lumbar Spine BMD Z-score at Month 6||0.673|-0.094|0.1322
91759532|NCT00799266|183411783|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|1.979||||0.0409|TWO_SIDED|95.0|0.089|3.869|||ANCOVA|||Lumbar Spine BMC at Month 6||3.869|0.089|0.0409
91759533|NCT00799266|183411783|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|2.155||||0.234|TWO_SIDED|95.0|-1.488|5.798|||ANCOVA|||Lumbar Spine BMC at Month 12||5.798|-1.488|0.2340
91759534|NCT00799266|183411784|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|34.058||||0.3827|TWO_SIDED|95.0|-45.385|113.502|||ANCOVA|||Total Body BMC at Month 6||113.502|-45.385|0.3827
91759535|NCT00799266|183411784|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|80.741||||0.2634|TWO_SIDED|95.0|-65.602|227.084|||ANCOVA|||Total Body BMC at Month 12||227.084|-65.602|0.2634
91759536|NCT00799266|183411785|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-211.782||||0.0631|TWO_SIDED|95.0|-363.765|-59.8|||ANCOVA|||Serum P1NP at Month 6||-59.800|-363.765|0.0631
91759537|NCT00799266|183411785|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-381.132||||0.0049|TWO_SIDED|95.0|-565.416|-196.848|||ANCOVA|||Serum P1NP at Month 12||-196.848|-565.416|0.0049
91759538|NCT00799266|183411786|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-11.223||||0.2129|TWO_SIDED|95.0|-22.595|0.149|||ANCOVA|||Serum BSAP at Month 6||0.149|-22.595|0.2129
91759539|NCT00799266|183411786|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.435||||0.0215|TWO_SIDED|95.0|-33.96|-6.909|||ANCOVA|||Serum BSAP at Month 12||-6.909|-33.960|0.0215
91759540|NCT00799266|183411787|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.938||||0.0254|TWO_SIDED|95.0|-33.766|-8.11|||ANCOVA|||Serum NTX at Month 6||-8.110|-33.766|0.0254
91759541|NCT00799266|183411787|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-27.574||||0.0002|TWO_SIDED|95.0|-39.037|-16.111|||ANCOVA|||Serum NTX at Month 12||-16.111|-39.037|0.0002
91759542|NCT00799266|183411788|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.874||||0.2178|TWO_SIDED|95.0|-3.931|0.182|||ANCOVA|||Serum TRAP-5b at Month 6||0.182|-3.931|0.2178
91759543|NCT00799266|183411788|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.837||||0.184|TWO_SIDED|95.0|-4.103|0.429|||ANCOVA|||Serum TRAP-5b at Month 12||0.429|-4.103|0.1840
91759544|NCT00799266|183411789|OTHER|The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher's exact test.||||||0.2258|||||||Fisher Exact|||New vertebral fractures at Month 12||||0.2258
91759545|NCT00799266|183411790|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.018||||0.318|TWO_SIDED|95.0|-0.055|0.019|||ANCOVA|||Vertebral morphometry at Month 12||0.019|-0.055|0.3180
91759546|NCT00799266|183411791|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.5226|TWO_SIDED|95.0|0.04|5.2|||Regression, Logistic|||Reduction in Pain at Month 3||5.20|0.04|0.5226
91759547|NCT00799266|183411791|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|999.99||||0.522|TWO_SIDED|95.0|0.01|999.99||\>999.99 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 6||999.99|0.01|0.5220
91508336|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.112||0.856|TWO_SIDED|95.0|-0.24|0.2|||MMRM|||Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.24|0.8560
91508337|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.125||0.9702|TWO_SIDED|95.0|-0.24|0.25|||MMRM|||Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.24|0.9702
91508338|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8001|TWO_SIDED|95.0|-0.25|0.2|||MMRM|||Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.25|0.8001
91532768|NCT00783718|182942359|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|11.6|31.7|||Cochran-Mantel-Haenszel|||The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator \[6-mercaptopurine or azathioprine\] use).||31.7|11.6|< 0.0001
91753941|NCT00897390|183400879|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.987|||||TWO_SIDED|90.0|0.9|1.083||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.083|0.900|
91753942|NCT00897390|183400882|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974|||||TWO_SIDED|90.0|0.921|1.03||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.030|0.921|
91753943|NCT00897390|183400882|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.966||||||90.0|0.915|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.915|
91753944|NCT00897390|183400883|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.962||||||90.0|0.906|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.906|
91753945|NCT00897390|183400883|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974||||||90.0|0.92|1.032||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.032|0.920|
91508339|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.109||0.3223|TWO_SIDED|95.0|-0.11|0.32|||MMRM|||Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.32|-0.11|0.3223
91508340|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.089||0.3385|TWO_SIDED|95.0|-0.26|0.09|||MMRM|||Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.09|-0.26|0.3385
91759548|NCT00799266|183411791|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.52||||0.6019|TWO_SIDED|95.0|0.04|6.22|||Regression, Logistic|||Reduction in Pain at Month 9||6.22|0.04|0.6019
91759549|NCT00799266|183411791|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.9652|TWO_SIDED|0.9652|0.01|999.99||0.45 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 12||999.99|0.01|0.9652
91759550|NCT00799266|183411792|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.04||||0.5165|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||2nd metacarpal cortical width at Month 12||0.09|-0.17|0.5165
91759551|NCT01336140|183411837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Chi-squared|||"We calculated that a minimum of 248 subjects are needed to attain 80% power to detect 70% reduction in the incidence of the primary endpoint (diarrhea), assuming an event rate of 15% in the control group (2-tailed α = 0.05). We targeted enrolling 300 patients to allow some room for error in our assumptions.~null hypothesis: incidence of diarrhea is no different between the aminophylline arm and the placebo arm."||||0.002
91759552|NCT01336140|183411838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91759553|NCT01336140|183411839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91759554|NCT01336140|183411840|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Chi-squared|||||||1
91759555|NCT01504841|183411842|OTHER||%|36.4|||||TWO_SIDED|95.0|10.9|69.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.|||69.2|10.9|
91759556|NCT01504841|183411842|OTHER||%|100.0|||||TWO_SIDED|95.0|39.8|100.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.|||100|39.8|
91759557|NCT01504841|183411845|OTHER||%|18.2|||||TWO_SIDED|95.0|2.5|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.|||51.8|2.5|
91759558|NCT01504841|183411845|OTHER||%|0.0|||||TWO_SIDED|95.0|0.0|60.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.|||60.2|0|
91759559|NCT01504841|183411846|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||51.8|2.3|
91759560|NCT01504841|183411846|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||80.6|0.6|
91759561|NCT01504841|183411846|OTHER||%|27.3|||||TWO_SIDED|95.0|6.0|61.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||61|6|
91759562|NCT01504841|183411846|OTHER||%|75.0|||||TWO_SIDED|95.0|19.4|99.4|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||99.4|19.4|
91759563|NCT01504841|183411850|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||41.3|0.2|
91759564|NCT01504841|183411850|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||93.2|6.8|
91759565|NCT01504841|183411850|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||41.3|0.2|
91759566|NCT01504841|183411850|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||80.6|0.6|
91759567|NCT01504841|183411850|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||51.8|2.3|
91759568|NCT01504841|183411850|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||93.2|6.8|
91759569|NCT04756804|183411851|OTHER|This was a descriptive study, no hypothesis testing was performed.|||||||||||||||||This was a descriptive study, no hypothesis testing was performed.|||
91759570|NCT00660179|183411860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.0108|TWO_SIDED|97.5|0.516|0.96|||Log Rank|||||0.960|0.516|0.0108
91759571|NCT00660179|183411860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.547|||<|0.0001|TWO_SIDED|97.5|0.392|0.762|||Log Rank|||||0.762|0.392|<0.0001
91759572|NCT00660179|183411861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.669||||0.0146|TWO_SIDED|97.5|0.462|0.97|||Log Rank|||||0.970|0.462|0.0146
91759573|NCT00660179|183411861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|97.5|0.335|0.747|||Log Rank|||||0.747|0.335|<0.0001
91753946|NCT00897390|183400884|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.937|||||TWO_SIDED|90.0|0.864|1.016||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.016|0.864|
91753947|NCT00897390|183400884|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.964|||||TWO_SIDED|90.0|0.891|1.042||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.042|0.891|
91753948|NCT04736199|183400901|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.0001|TWO_SIDED|95.0|0.413|0.707||One-sided|Log Rank|||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.707|0.413|<0.0001
91753949|NCT04736199|183400902|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.1007|TWO_SIDED|95.0|0.591|1.118||One-sided|Log Rank||significance level of 0.0185 (one-sided)|Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||1.118|0.591|0.1007
91753950|NCT04736199|183400903|OTHER||Hazard Ratio (HR)|0.404|||||TWO_SIDED|95.0|0.321|0.508||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.508|0.321|
91753951|NCT04736199|183400904|OTHER||Hazard Ratio (HR)|0.401|||||TWO_SIDED|95.0|0.288|0.558||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.558|0.288|
91753952|NCT04736199|183400905|OTHER||Hazard Ratio (HR)|0.306|||||TWO_SIDED|95.0|0.231|0.405||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.405|0.231|
91753953|NCT04736199|183400906|OTHER||Rate difference|44.3|||||TWO_SIDED|95.0|37.4|51.2||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||51.2|37.4|
91753954|NCT04736199|183400907|OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.544|0.957||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.957|0.544|
91753955|NCT05926544|183400935|SUPERIORITY||Risk Ratio (RR)|0.46|||||TWO_SIDED|95.0|0.18|1.16|||||The Standard implementation arm was the reference group.|||1.16|0.18|
91753956|NCT05818137|183400942|OTHER||Change from baseline estimate|-99.2|||||TWO_SIDED|95.0|-129.6|-68.4|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-68.4|-129.6|
91753957|NCT05818137|183400945|OTHER||Change from baseline estimate|41.8|||||TWO_SIDED|95.0|27.8|55.5|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||55.5|27.8|
91753958|NCT05818137|183400947|OTHER||Change from baseline estimate|-48.5|||||TWO_SIDED|95.0|-77.0|-24.8|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-24.8|-77.0|
91753959|NCT05925374|183400953|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91753960|NCT05925374|183400954|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
91753961|NCT05925374|183400955|OTHER|||||||0.136|||||||t-test, 2 sided|||||||0.136
91753962|NCT03320330|183400974|OTHER|Recommended Phase 2 dose of pepinemab (VX15/2503), administered to children with recurrent or refractory solid tumors (Part A), was determined by the rolling-6 design.|Recommended Phase 2 dose|20.0|||||TWO_SIDED||||||||Recommended Phase 2 dose of pepinemab (VX15/2503) is 20 mg/kg.|||||
91753963|NCT05206370|183400986|SUPERIORITY|Abstinence from Week 3 to Week 6|Odds Ratio (OR)|2.85||||0.0008|TWO_SIDED|95.0|1.475|5.617||Two-sided, calculated by exact computations with clinical site as a stratifier.|Exact computations||Common odds ratio (stratified by site)|||5.617|1.475|0.0008
91753964|NCT05206370|183400986|SUPERIORITY||Odds Ratio (OR)|2.71||||0.001|TWO_SIDED|95.0|1.485|5.094||Two-sided, derived from marginal odds ratio|Exact computations||Marginal (unadjusted) odds ratio|||5.094|1.485|0.0010
91753965|NCT05206370|183400986|SUPERIORITY||Difference in proportions|0.09||||0.0006|TWO_SIDED|95.0|0.033|0.134||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.134|0.033|0.0006
91753966|NCT05206370|183400987|SUPERIORITY||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.566|7.343||Two-sided, calculated by exact computations with clinical site as a stratifier.|Exact computations||Common odds ratio (stratified by site)|Abstinence from Week 9 to Week 12||7.343|2.566|< 0.0001
91753967|NCT05206370|183400987|SUPERIORITY||Odds Ratio (OR)|4.17|||<|0.0001|TWO_SIDED|95.0|2.575|6.885||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||6.885|2.575|< 0.0001
91759574|NCT00660179|183411862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.9249|TWO_SIDED|97.5|0.477|1.976|||Log Rank|||||1.976|0.477|0.9249
91759575|NCT00660179|183411862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.638||||0.2037|TWO_SIDED|97.5|0.287|1.418|||Log Rank|||||1.418|0.287|0.2037
91508341|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7003|TWO_SIDED|95.0|-0.16|0.24|||MMRM|||Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.24|-0.16|0.7003
91508342|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.099||0.0311|TWO_SIDED|95.0|-0.41|-0.02|||MMRM|||Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||-0.02|-0.41|0.0311
91508343|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1976|TWO_SIDED|95.0|-0.26|0.06|||MMRM|||Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.06|-0.26|0.1976
91532769|NCT00783718|182942360|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.0001|TWO_SIDED|95.0|14.9|37.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||37.2|14.9|< 0.0001
91759576|NCT00660179|183411863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.8312|TWO_SIDED|97.5|0.653|1.673|||Log Rank|||||1.673|0.653|0.8312
91759577|NCT00660179|183411863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.771||||0.2509|TWO_SIDED|97.5|0.464|1.282|||Log Rank|||||1.282|0.464|0.2509
91759578|NCT01504412|183411902|SUPERIORITY||Hazard Ratio (HR)|-0.42||||0.1995|TWO_SIDED|95.0|-0.99|0.15||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.15|-0.99|0.1995
91759579|NCT01504412|183411902|SUPERIORITY||Hazard Ratio (HR)|-0.37||||0.2886|TWO_SIDED|95.0|-0.93|0.2||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.20|-0.93|0.2886
91759580|NCT01504412|183411902|SUPERIORITY||Hazard Ratio (HR)|-0.3||||0.4704|TWO_SIDED|95.0|-0.87|0.27||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.27|-0.87|0.4704
91759581|NCT01504412|183411903|SUPERIORITY||Least squares mean difference|-5.2||||0.0691|TWO_SIDED|95.0|-10.8|0.4|||ANCOVA|||This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.||0.4|-10.8|0.0691
91759582|NCT01504412|183411903|SUPERIORITY||Least squares mean difference|-5.4||||0.0577|TWO_SIDED|95.0|-10.9|0.2|||ANCOVA|||This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.||0.2|-10.9|0.0577
91759583|NCT01504412|183411903|SUPERIORITY||Least squares mean difference|-7.4||||0.0093|TWO_SIDED|95.0|-13.0|-1.8|||ANCOVA|||This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.||-1.8|-13.0|0.0093
91759584|NCT05362058|183411913|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.09|||||TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|
91759585|NCT05362058|183411914|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||||0.13|-0.26|
91759586|NCT05362058|183411915|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.28|0.07|||ANCOVA|||||0.07|-0.28|
91759587|NCT05362058|183411916|SUPERIORITY||LS Mean Difference|-0.09||||0.188|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|0.188
91759588|NCT05362058|183411917|SUPERIORITY||LS Mean Difference|3.09||||0.043|TWO_SIDED|95.0|0.09|6.08|||ANCOVA|||||6.08|0.09|0.043
91759589|NCT05362058|183411918|SUPERIORITY||LS Mean Difference|-0.06||||0.26|TWO_SIDED|95.0|-0.17|0.05|||ANCOVA|||||0.05|-0.17|0.260
91759590|NCT05362058|183411919|SUPERIORITY||LS Mean Difference|0.27||||0.848|TWO_SIDED|95.0|-2.48|3.02|||ANCOVA|||||3.02|-2.48|0.848
91759591|NCT05362058|183411920|SUPERIORITY||LS Mean Difference|5.18||||0.014|TWO_SIDED|95.0|1.06|9.3|||ANCOVA|||Week 26 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 26 were imputed by return-to-baseline multiple imputations approach.||9.30|1.06|0.014
91759592|NCT05362058|183411920|SUPERIORITY||LS Mean Difference|0.2||||0.918|TWO_SIDED|95.0|-3.65|4.06|||ANCOVA|||Week 52 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 52 were imputed by return-to-baseline multiple imputations approach.||4.06|-3.65|0.918
91759593|NCT05362058|183411921|SUPERIORITY||LS Mean Difference|-0.36||||0.31|TWO_SIDED|95.0|-1.06|0.34|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.34|-1.06|0.310
91759594|NCT05362058|183411921|SUPERIORITY||LS Mean Difference|-0.51||||0.138|TWO_SIDED|95.0|-1.19|0.17|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.17|-1.19|0.138
91759595|NCT05362058|183411922|SUPERIORITY||LS Mean Difference|-13.2||||0.136|TWO_SIDED|95.0|-30.5|4.1|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||4.1|-30.5|0.136
91759596|NCT05362058|183411922|SUPERIORITY||LS Mean Difference|-19.7||||0.026|TWO_SIDED|95.0|-37.0|-2.4|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||-2.4|-37.0|0.026
91759597|NCT05362058|183411923|SUPERIORITY||Relative Rate|1.3||||0.111|TWO_SIDED|95.0|0.94|1.78|||Negative binomial model|||||1.78|0.94|0.111
91759598|NCT05362058|183411924|SUPERIORITY||Relative Rate|1.01||||0.983|TWO_SIDED|95.0|0.53|1.89|||Negative binomial model|||||1.89|0.53|0.983
91759599|NCT05362058|183411925|SUPERIORITY||LS Mean Difference|0.5||||0.025|TWO_SIDED|95.0|0.064|0.94|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||0.94|0.064|0.025
91759600|NCT05362058|183411925|SUPERIORITY||LS Mean Difference|0.056||||0.801|TWO_SIDED|95.0|-0.38|0.5|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||0.50|-0.38|0.801
91759601|NCT05362058|183411926|SUPERIORITY||LS Mean Difference|0.13||||0.374|TWO_SIDED|95.0|-0.15|0.41|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.41|-0.15|0.374
91759602|NCT05362058|183411926|SUPERIORITY||LS Mean Difference|0.29||||0.13|TWO_SIDED|95.0|-0.09|0.67|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.67|-0.09|0.130
91759603|NCT05362058|183411926|SUPERIORITY||LS Mean Difference|0.3||||0.162|TWO_SIDED|95.0|-0.12|0.72|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.72|-0.12|0.162
91759604|NCT05362058|183411927|SUPERIORITY||LS Mean Difference|-0.03||||0.594|TWO_SIDED|95.0|-0.15|0.08|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.08|-0.15|0.594
91759605|NCT05362058|183411927|SUPERIORITY||LS Mean Difference|0.06||||0.266|TWO_SIDED|95.0|-0.04|0.16|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.16|-0.04|0.266
91759606|NCT05362058|183411927|SUPERIORITY||LS Mean Difference|0.02||||0.791|TWO_SIDED|95.0|-0.1|0.14|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.14|-0.10|0.791
91759607|NCT05362058|183411928|SUPERIORITY||LS Mean Difference|-0.41||||0.757|TWO_SIDED|95.0|-3.0|2.18|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||2.18|-3.00|0.757
91759608|NCT05362058|183411928|SUPERIORITY||LS Mean Difference|-0.93||||0.511|TWO_SIDED|95.0|-3.72|1.85|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||1.85|-3.72|0.511
91759609|NCT05362058|183411928|SUPERIORITY||LS Mean Difference|-3.39||||0.027|TWO_SIDED|95.0|-6.39|-0.39|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||-0.39|-6.39|0.027
91759610|NCT05362058|183411929|SUPERIORITY||LS Mean Difference|1.66||||0.021|TWO_SIDED|95.0|0.26|3.07|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||3.07|0.26|0.021
91508344|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.092||0.5489|TWO_SIDED|95.0|-0.24|0.13|||MMRM|||Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.24|0.5489
91753968|NCT05206370|183400987|SUPERIORITY||Difference in proportions|0.21|||<|0.0001|TWO_SIDED|95.0|0.141|0.267||p-value for difference in proportions4|Cochran-Mantel-Haenszel|||||0.267|0.141|< 0.0001
91753969|NCT05206370|183400988|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0006|TWO_SIDED|95.0|1.851|34.619||Two-sided, calculated by exact computations with clinical site as a stratifier.|Exact computations||Common odds ratio (Stratified by site)|Abstinence from Week 6 to Week 24||34.619|1.851|0.0006
91753970|NCT05206370|183400988|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0007|TWO_SIDED|95.0|2.026|27.544||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||27.544|2.026|0.0007
91753971|NCT05206370|183400988|SUPERIORITY||Difference in proportions|0.06||||0.0007|TWO_SIDED|95.0|0.023|0.075||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.075|0.023|0.0007
91753972|NCT05206370|183400989|SUPERIORITY||Odds Ratio (OR)|5.79|||<|0.0001|TWO_SIDED|95.0|2.888|12.458||Two-sided, calculated by exact computations with clinical site as a stratifier.|Exact computations||Common odds ratio (stratified by site)|Abstinence from Week 9 to Week 24||12.458|2.888|< 0.0001
91753973|NCT05206370|183400989|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|3.091|12.13||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||12.130|3.091|< 0.0001
91753974|NCT05206370|183400989|SUPERIORITY||Difference in proportions|0.16|||<|0.0001|TWO_SIDED|95.0|0.11|0.202||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.202|0.110|< 0.0001
91753975|NCT05206370|183400990|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5538|TWO_SIDED|95.0|0.652|2.297||Two-sided, calculated by exact computations with clinical site as a stratifier.|Exact computations||Common odds ratio (stratified by site)|Relapse free at Week 24||2.297|0.652|0.5538
91508345|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7992|TWO_SIDED|95.0|-0.17|0.13|||MMRM|||Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.17|0.7992
91753976|NCT05206370|183400990|SUPERIORITY||Odds Ratio (OR)|1.24||||0.556|TWO_SIDED|95.0|0.691|2.231||Two-sided, derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||2.231|0.691|0.5560
91753977|NCT05206370|183400990|SUPERIORITY|||||||0.2822|||||||Zelen's exact test (Pr ≤ P)|||||||0.2822
91753978|NCT06038123|183401058|SUPERIORITY||Proportion|100.0||||0.002|ONE_SIDED|97.5|93.94|||A priori threshold for statistical significance was 0.025|One-proportion binomial exact test|||Alternative hypothesis: MRI-related event-free rate within 1-month post-MRI \>90%. Null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is \>90%. Assuming type I error rate of 0.025, even-free rate under null hypothesis being 90% and true even-free rate being 99.5%, the minimum required sample size is 54 MRI scanned patients to achieve 90% power. One-proportion binomial exact test along with a one-sided 97.5% lower (Clopper-Pearson) confidence bound was used.|||93.94|0.002
91753979|NCT05218499|183401060|OTHER||Hazard Ratio (HR)|0.79||||0.0956|TWO_SIDED|95.0|0.6|1.06|||Regression, Cox||A hazard ratio value below 1 favors brigimadlin.|The primary estimator for the hazard ratio is the median unbiased estimator. The confidence interval (CI) for the hazard ratio is calculated as a repeated CI. The p-value is obtained using a weighted inverse normal method combining one-sided p-values from two stages.||1.06|0.60|0.0956
91753980|NCT05218499|183401061|OTHER||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.52|5.67|||||An odds ratio value greater than 1 favors brigimadlin.|The primary estimator and CI for the odds ratio is by Cochran-Mantel-Haenszel.||5.67|1.52|
91753981|NCT05218499|183401063|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.81|2.82|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate.||2.82|0.81|
91753982|NCT05218499|183401063|OTHER||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.48|4.84|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate. Exact 95% confidence interval (CI) by Clopper and Pearson.||4.84|1.48|
91753983|NCT06426927|183401098|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Post-video vs. Baseline||||<0.0001
91753984|NCT06426927|183401098|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Study Day 2: 30 +/- 7 days vs. Baseline||||<0.0001
91753985|NCT06426927|183401099|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Post-video vs. Baseline||||<0.0001
91753986|NCT06426927|183401099|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Study Day 2: 30 +/- 7 days vs. Baseline||||<0.0001
91753987|NCT06426927|183401100|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Post-video vs. Baseline||||<0.0001
91753988|NCT06426927|183401100|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Study Day 2: 30 +/- 7 days vs. Baseline||||<0.0001
91753989|NCT06426927|183401101|SUPERIORITY||Average Causal Mediated Effect (ACME)|0.01||||0.56|TWO_SIDED||||||Mixed Models Analysis|||Pre-video to post video, without covariates||||0.56
91753990|NCT05010018|183401102|OTHER|||||||0.22|||||||welch's t-test|||||||0.22
91753991|NCT05431387|183401114|SUPERIORITY||Odds Ratio (OR)|2.64||||0.035|TWO_SIDED|95.0|1.062|7.098||Two-sided, calculated by exact computations with whether subjects had smoked \>100 cigarettes in their lifetime (yes, no) as stratification.|Exact computations||Common odds ratio|Abstinence from Week 9 to 12||7.098|1.062|0.0350
91508346|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.103||0.0573|TWO_SIDED|95.0|-0.4|0.01|||MMRM|||Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.40|0.0573
91753992|NCT05431387|183401114|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0348|TWO_SIDED|95.0|1.133|6.491||Derived from marginal odds ratio.|Exact computations||Marginal (unadjusted) odds ratio|||6.491|1.133|0.0348
91753993|NCT05431387|183401114|SUPERIORITY||Difference in proportions|0.17||||0.012|TWO_SIDED|95.0|0.012|0.284||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.284|0.012|0.0120
91753994|NCT05431387|183401115|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2205|TWO_SIDED|95.0|0.766|4.551|||Exact computations||Marginal (unadjusted) odds ratio|Abstinence from Week 3 to 6||4.551|0.766|0.2205
91753995|NCT05431387|183401115|SUPERIORITY||Difference in proportions|0.09|||||TWO_SIDED|95.0|-0.058|0.209||||||||0.209|-0.058|
91753996|NCT05431387|183401116|SUPERIORITY||Odds Ratio (OR)|2.18||||0.085|TWO_SIDED|95.0|0.967|5.202|||Exact computations||Marginal (unadjusted) odds ratio|Abstinence from Week 6 to 9||5.202|0.967|0.0850
91753997|NCT05431387|183401116|SUPERIORITY||Difference in proportions|0.14|||||TWO_SIDED|95.0|-0.019|0.263||||||||0.263|-0.019|
91753998|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|2.0||||0.3038|TWO_SIDED|95.0|0.653|7.309||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 2||7.309|0.653|0.3038
91753999|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.06||||0.3038|TWO_SIDED|95.0|-0.058|0.144||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 2||0.144|-0.058|0.3038
91754000|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|1.73||||0.1996|TWO_SIDED|95.0|0.817|3.8||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 3||3.800|0.817|0.1996
91754001|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.11||||0.1996|TWO_SIDED|95.0|-0.055|0.251||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 3||0.251|-0.055|0.1996
91754002|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|3.02||||0.0035|TWO_SIDED|95.0|1.458|6.414||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 4||6.414|1.458|0.0035
91754003|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.25||||0.0035|TWO_SIDED|95.0|0.078|0.395||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 4||0.395|0.078|0.0035
91754004|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1183|TWO_SIDED|95.0|0.905|3.809||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 5||3.809|0.905|0.1183
91754005|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.14||||0.1183|TWO_SIDED|95.0|-0.035|0.29||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 5||0.290|-0.035|0.1183
91754006|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0532|TWO_SIDED|95.0|1.035|4.585||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 6||4.585|1.035|0.0532
91754007|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.17||||0.0532|TWO_SIDED|95.0|-0.004|0.311||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 6||0.311|-0.004|0.0532
91754008|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0019|TWO_SIDED|95.0|1.539|6.989||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 7||6.989|1.539|0.0019
91754009|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.26||||0.0019|TWO_SIDED|95.0|0.089|0.4||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 7||0.400|0.089|0.0019
91754010|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0246|TWO_SIDED|95.0|1.119|4.944||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 8||4.944|1.119|0.0246
91754011|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.18||||0.0246|TWO_SIDED|95.0|0.014|0.33||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 8||0.330|0.014|0.0246
91754012|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0362|TWO_SIDED|95.0|1.076|4.762||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 9||4.762|1.076|0.0362
91754013|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.18||||0.0362|TWO_SIDED|95.0|0.005|0.321||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 9||0.321|0.005|0.0362
91754014|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|1.77||||0.1215|TWO_SIDED|95.0|0.871|3.668||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 10||3.668|0.871|0.1215
91754015|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.13||||0.1215|TWO_SIDED|95.0|-0.044|0.281||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 10||0.281|-0.044|0.1215
91754016|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1123|TWO_SIDED|95.0|0.882|3.935||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 11||3.935|0.882|0.1123
91754017|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.13||||0.1123|TWO_SIDED|95.0|-0.04|0.274||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 11||0.274|-0.040|0.1123
91754018|NCT05431387|183401117|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0516|TWO_SIDED|95.0|1.006|4.626||Two-sided, derived from marginal (unadjusted) odds ratio.|Exact computations|||Week 12||4.626|1.006|0.0516
91754019|NCT05431387|183401117|SUPERIORITY||Difference in proportions|0.16||||0.0516|TWO_SIDED|95.0|-0.011|0.298||Two-sided, derived from marginal odds ratio.|Exact computations|||Week 12||0.298|-0.011|0.0516
91754020|NCT05431387|183401118|SUPERIORITY||Least squares (LS) means difference|-32.506|STANDARD_ERROR_OF_MEAN|32.6646||1|TWO_SIDED|95.0|-155.1192|90.1072||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 2||90.1072|-155.1192|1.0000
91754021|NCT05431387|183401118|SUPERIORITY||LS means difference|-72.832|STANDARD_ERROR_OF_MEAN|32.6388||1|TWO_SIDED|95.0|-195.3491|49.6842||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 3||49.6842|-195.3491|1.0000
91754022|NCT05431387|183401118|SUPERIORITY||LS means difference|-74.09|STANDARD_ERROR_OF_MEAN|32.8018||1|TWO_SIDED|95.0|-197.2184|49.0381||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 4||49.0381|-197.2184|1.0000
91508347|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0431|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0431
91754023|NCT05431387|183401118|SUPERIORITY||LS means difference|-83.364|STANDARD_ERROR_OF_MEAN|32.7865||1|TWO_SIDED|95.0|-206.4354|39.7066||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 5||39.7066|-206.4354|1.0000
91754024|NCT05431387|183401118|SUPERIORITY||LS means difference|-79.952|STANDARD_ERROR_OF_MEAN|32.9139||1|TWO_SIDED|95.0|-203.5009|43.5976||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 6||43.5976|-203.5009|1.0000
91754025|NCT05431387|183401118|SUPERIORITY||LS means difference|-49.309|STANDARD_ERROR_OF_MEAN|33.2714||1|TWO_SIDED|95.0|-174.2006|75.5817||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 7||75.5817|-174.2006|1.0000
91754026|NCT05431387|183401118|SUPERIORITY||LS means difference|-78.107|STANDARD_ERROR_OF_MEAN|33.2237||1|TWO_SIDED|95.0|-202.8196|46.6046||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 8||46.6046|-202.8196|1.0000
91754027|NCT05431387|183401118|SUPERIORITY||LS means difference|-86.006|STANDARD_ERROR_OF_MEAN|33.5025||1|TWO_SIDED|95.0|-211.7643|39.7529||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 9||39.7529|-211.7643|1.0000
91754028|NCT05431387|183401118|SUPERIORITY||LS means difference|-62.68|STANDARD_ERROR_OF_MEAN|33.151||1|TWO_SIDED|95.0|-187.1187|61.7592||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 10||61.7592|-187.1187|1.0000
91754029|NCT05431387|183401118|SUPERIORITY||LS means difference|-63.262|STANDARD_ERROR_OF_MEAN|33.2292||1|TWO_SIDED|95.0|-187.9952|61.4704||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 11||61.4704|-187.9952|1.0000
91508348|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.108||0.006|TWO_SIDED|95.0|-0.52|-0.09|||MMRM|||Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.52|0.0060
91754030|NCT05431387|183401118|SUPERIORITY||LS means difference|-57.329|STANDARD_ERROR_OF_MEAN|33.2475||1|TWO_SIDED|95.0|-182.1302|67.4727||A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported.|Compound symmetry covariance matrix|||Change at Week 12||67.4727|-182.1302|1.0000
91754031|NCT05431387|183401119|SUPERIORITY||Odds Ratio (OR)|2.0||||0.147|TWO_SIDED|95.0|0.82|5.319||Two-sided, derived from marginal odds ratio.|Exact computations|||Abstinence from Week 9 to 16||5.319|0.820|0.1470
91754032|NCT05431387|183401119|SUPERIORITY||Difference in proportions|0.1||||0.147|TWO_SIDED|95.0|-0.044|0.211||Two-sided, derived from marginal odds ratio.|Exact computations|||||0.211|-0.044|0.1470
91759611|NCT05362058|183411929|SUPERIORITY||LS Mean Difference|2.0||||0.006|TWO_SIDED|95.0|0.57|3.44|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||3.44|0.57|0.006
91759612|NCT05362058|183411930|SUPERIORITY||LS Mean Difference|-0.2||||0.638|TWO_SIDED|95.0|-1.03|0.63|||Mixed Models Analysis|||Physical Component Score at Week 26 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.63|-1.03|0.638
91759613|NCT05362058|183411930|SUPERIORITY||LS Mean Difference|-0.32||||0.499|TWO_SIDED|95.0|-1.24|0.6|||Mixed Models Analysis|||Mental Component Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-1.24|0.499
91759614|NCT05362058|183411930|SUPERIORITY||LS Mean Difference|0.17||||0.695|TWO_SIDED|95.0|-0.68|1.01|||Mixed Models Analysis|||Physical Component Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.01|-0.68|0.695
91759615|NCT05362058|183411930|SUPERIORITY||LS Mean Difference|-0.23||||0.626|TWO_SIDED|95.0|-1.17|0.71|||Mixed Models Analysis|||Mental Component Score at Week 52 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.71|-1.17|0.626
91759616|NCT05362058|183411931|SUPERIORITY||LS Mean Difference|-0.015||||0.128|TWO_SIDED|95.0|-0.034|0.004|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.004|-0.034|0.128
91759617|NCT05362058|183411931|SUPERIORITY||LS Mean Difference|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.58|||Mixed Models Analysis|||EQ VAS Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.58|-2.80|0.196
91759618|NCT05362058|183411931|SUPERIORITY||LS Mean Difference|-0.01||||0.285|TWO_SIDED|95.0|-0.029|0.008|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.008|-0.029|0.285
91508349|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.127||0.0215|TWO_SIDED|95.0|-0.55|-0.04|||MMRM|||Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.55|0.0215
91508350|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.109||0.0422|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0422
91508351|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.126||0.0433|TWO_SIDED|95.0|-0.51|-0.01|||MMRM|||Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.51|0.0433
91508352|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.0051|TWO_SIDED|95.0|-0.57|-0.1|||MMRM|||Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.57|0.0051
91754033|NCT04088331|183401167|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||"Hypotheses:~H0: p ≤ 0.65 H1: p \> 0.65 where p = the proportion of subjects who are a treatment success.~Hypotheses evaluated using a one-sided exact binomial test.~Power calculation assumed a treatment success rate of 80%. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size of 96 subjects needed to demonstrate the proportion of subjects who are a treatment success exceeds 65%."||||< 0.001
91754034|NCT03500172|183401179|SUPERIORITY|||||||0.455||||||Threshold for significance: 0.05|Two sample test of proportions|||||||0.455
91754035|NCT03500172|183401180|SUPERIORITY|||||||0.962||||||Statistical significance threshold: 0.05|Two sample test of proportions|||||||0.962
91754036|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.05|TWO_SIDED|95.0|0.61|0.99||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for steady partner, living together vs. single.||0.99|0.61|<0.05
91754037|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|1.6|||<|0.05|TWO_SIDED|95.0|1.02|2.51||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.||2.51|1.02|<0.05
91754038|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|1.31|||<|0.05|TWO_SIDED|95.0|1.09|1.57||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 days||1.57|1.09|<0.05
91754039|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|1.24|||<|0.05|TWO_SIDED|95.0|1.01|1.52||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months.||1.52|1.01|<0.05
91754040|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|1.62|||<|0.05|TWO_SIDED|95.0|1.31|2.0||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have not||2.00|1.31|<0.05
91754041|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|2.33|||<|0.05|TWO_SIDED|95.0|1.65|3.29||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. \<50 copies/mL.||3.29|1.65|<0.05
91754042|NCT03500172|183401181|SUPERIORITY||Hazard Ratio (HR)|2.47|||<|0.05|TWO_SIDED|95.0|1.82|3.36||Threshold for significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL.||3.36|1.82|<0.05
91508353|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.133||0.0973|TWO_SIDED|95.0|-0.48|0.04|||MMRM|||Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.48|0.0973
91508354|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.126||0.0036|TWO_SIDED|95.0|-0.63|-0.13|||MMRM|||Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.63|0.0036
91754043|NCT03500172|183401182|SUPERIORITY|||||||0.756||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.756
91754044|NCT03500172|183401183|SUPERIORITY|||||||0.295||||||Threshold of statistical significance: 0.05|Two sample test of proportions|||||||0.295
91754045|NCT03500172|183401184|SUPERIORITY|||||||0.149||||||Threshold for statistical significance: 0.05|Two sample test of proportions|||||||0.149
91754046|NCT03500172|183401185|SUPERIORITY|||||||0.301||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.301
91754047|NCT03500172|183401188|SUPERIORITY|||||||0.212||||||Threshold of statistical significance: 0.05|Chi-squared|||||||0.212
91532770|NCT00783718|182942360|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.1|||<|0.0001|TWO_SIDED|95.0|17.9|40.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||40.4|17.9|< 0.0001
91754048|NCT03298451|183401205|SUPERIORITY|||||||0.0035||||||The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0035
91754049|NCT03298451|183401205|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.66|0.92|||Regression, Cox|||The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||0.92|0.66|
91754050|NCT03298451|183401206|NON_INFERIORITY|Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.67|0.73|1.03|||Regression, Cox||The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||1.03|0.73|
91754051|NCT03298451|183401206|SUPERIORITY|Superiority was tested sequentially per protocol as non-inferiority was satisfied.||||||0.0674||||||The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0674
91754052|NCT03824158|183401222|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
91754053|NCT03824158|183401223|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||||||0.76
91754054|NCT03824158|183401224|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
91754055|NCT03824158|183401225|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
91754056|NCT03824158|183401226|SUPERIORITY|||||||0.002|||||||Chi-squared|||Advance directive or living will||||0.002
91754057|NCT03824158|183401226|SUPERIORITY|||||||0.02|||||||Fisher Exact|||POLST||||0.02
91754058|NCT03824158|183401226|SUPERIORITY|||||||0.78|||||||Chi-squared|||Code Status||||0.78
91754059|NCT03824158|183401226|SUPERIORITY|||||||0.61|||||||Chi-squared|||Goals of Care discussion||||0.61
91754060|NCT03824158|183401227|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
91754061|NCT03824158|183401228|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91754062|NCT03824158|183401229|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
91754063|NCT03824158|183401230|SUPERIORITY|||||||0.83|||||||Fisher Exact|||||||0.83
91754064|NCT03824158|183401231|SUPERIORITY|||||||0.32||||||Total Score p-value|Wilcoxon (Mann-Whitney)|||||||0.32
91754065|NCT03824158|183401232|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||IES-R Total Score p-value||||0.01
91754066|NCT03824158|183401233|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
91754067|NCT03824158|183401234|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91754068|NCT03824158|183401235|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
91754069|NCT03824158|183401236|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.4
91754070|NCT03824158|183401237|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
91754071|NCT03824158|183401238|SUPERIORITY|||||||0.38|||||||Chi-squared|||||||0.38
91754072|NCT03824158|183401239|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
91754073|NCT03824158|183401240|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
91754074|NCT03824158|183401241|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
91754075|NCT04908280|183401244|SUPERIORITY|||||||0.0308|||||||ANOVA|||||||0.0308
91754076|NCT06987201|183401259|OTHER|Test for Difference Between Groups|Mean Difference (Final Values)|-2.65|||<|0.001|TWO_SIDED|95.0|-3.398|-1.902|||t-test, 2 sided|||||-1.902|-3.398|<0.001
91754077|NCT01299571|183401260|SUPERIORITY_OR_OTHER||Percentage of participants|3.8||||||95.0|3.2|4.4|||||The estimated value represents the percentage of participants with adverse events.|||4.4|3.2|
91754078|NCT02486718|183401263|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.848||||0.0683|TWO_SIDED|95.0|0.71|1.013|||Log Rank|||||1.013|0.710|0.0683
91754079|NCT02486718|183401264|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.691|0.998||||||||0.998|0.691|
91754080|NCT02486718|183401265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.704|||||TWO_SIDED|95.0|0.545|0.91||||||||0.910|0.545|
91754081|NCT02486718|183401267|SUPERIORITY||Difference in event-free rates|5.98|||||TWO_SIDED|95.0|-0.28|12.23||||||||12.23|-0.28|
91754082|NCT02486718|183401268|SUPERIORITY||Difference in event-free rates|6.65|||||TWO_SIDED|95.0|-0.06|13.36||||||||13.36|-0.06|
91754083|NCT02486718|183401269|SUPERIORITY||Difference in event-free rates|10.67|||||TWO_SIDED|95.0|1.56|19.79||||||||19.79|1.56|
91754084|NCT02486718|183401270|SUPERIORITY||Difference in event-free rates|5.48|||||TWO_SIDED|95.0|-0.94|11.9||||||||11.90|-0.94|
91754085|NCT02486718|183401271|SUPERIORITY||Difference in event-free rates|4.88|||||TWO_SIDED|95.0|-1.94|11.7||||||||11.70|-1.94|
91754086|NCT02486718|183401272|SUPERIORITY||Difference in event-free rates|10.46|||||TWO_SIDED|95.0|1.16|19.76||||||||19.76|1.16|
91508355|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.131||0.0498|TWO_SIDED|95.0|-0.52|0.0|||MMRM|||Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.52|0.0498
91532771|NCT00783718|182942361|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.5||||0.0009|TWO_SIDED|95.0|4.7|18.3||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||18.3|4.7|0.0009
91754087|NCT02486718|183401273|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.503|||||TWO_SIDED|95.0|0.332|0.761||||||||0.761|0.332|
91754088|NCT04865770|183401320|OTHER||Treatment ratio|0.98||||0.1333|TWO_SIDED|95.0|0.96|1.01|||ANCOVA|||Bilateral cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.||1.01|0.96|0.1333
91754089|NCT04865770|183401320|OTHER||Treatment ratio|0.99||||0.2487|TWO_SIDED|95.0|0.96|1.01|||ANCOVA|||Right cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.||1.01|0.96|0.2487
91754090|NCT04865770|183401320|OTHER||Treatment ratio|0.97||||0.0907|TWO_SIDED|95.0|0.94|1.0|||ANCOVA|||Left cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.||1.00|0.94|0.0907
91754091|NCT04865770|183401321|OTHER||Treatment ratio|0.99||||0.5619|TWO_SIDED|95.0|0.94|1.03|||ANCOVA|||Bilateral medulla: The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.03|0.94|0.5619
91754092|NCT04865770|183401321|OTHER||Treatment ratio|0.97||||0.2774|TWO_SIDED|95.0|0.93|1.02|||ANCOVA|||Right medulla: The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.02|0.93|0.2774
91754093|NCT04865770|183401321|OTHER||Treatment ratio|0.99||||0.7924|TWO_SIDED|95.0|0.94|1.04|||ANCOVA|||Left medulla: The responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.04|0.94|0.7924
91754094|NCT04865770|183401322|OTHER||Treatment ratio|1.1||||0.0958|TWO_SIDED|95.0|0.98|1.24|||ANCOVA|||Bilateral kidney: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.24|0.98|0.0958
91754095|NCT04865770|183401322|OTHER||Treatment ratio|1.17||||0.0145|TWO_SIDED|95.0|1.03|1.33|||ANCOVA|||Right kidney: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.33|1.03|0.0145
91754096|NCT04865770|183401322|OTHER||Treatment ratio|1.06||||0.3311|TWO_SIDED|95.0|0.94|1.21|||ANCOVA|||Left kidney: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.21|0.94|0.3311
91754097|NCT04865770|183401323|OTHER||Treatment ratio|1.0||||0.8651|TWO_SIDED|95.0|0.98|1.02|||ANCOVA|||Bilateral cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.02|0.98|0.8651
91754098|NCT04865770|183401323|OTHER||Treatment ratio|1.0||||0.724|TWO_SIDED|95.0|0.98|1.02|||ANCOVA|||Right cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.02|0.98|0.7240
91754099|NCT04865770|183401323|OTHER||Treatment ratio|1.0||||0.7195|TWO_SIDED|95.0|0.98|1.02|||ANCOVA|||Left cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.02|0.98|0.7195
91754100|NCT04865770|183401324|OTHER||Treatment ratio|1.0||||0.9335|TWO_SIDED|95.0|0.98|1.02|||ANCOVA|||Bilateral medulla: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.02|0.98|0.9335
91754101|NCT04865770|183401324|OTHER||Treatment ratio|1.0||||0.6517|TWO_SIDED|95.0|0.98|1.01|||ANCOVA|||Right medulla: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.01|0.98|0.6517
91754102|NCT04865770|183401324|OTHER||Treatment ratio|1.0||||0.9017|TWO_SIDED|95.0|0.98|1.02|||ANCOVA|||Left medulla: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate.||1.02|0.98|0.9017
91754103|NCT04763824|183401334|OTHER|Fisher Exact tests|||||<|0.05|||||||Chi-squared|Also used Fisher exact tests.||Differences in cancer survivorship performance indicators and surveillance rates by tumor types before and after intervention were assessed using Fisher Exact tests.||||<0.05
91754104|NCT04763824|183401336|OTHER|Fisher exact tests|||||<|0.05|||||||Fisher Exact|||Differences in cancer survivorship performance indicators and surveillance rates by tumor types before and after intervention were assessed using Fisher Exact tests.||||<0.05
91754105|NCT04763824|183401338|OTHER|Fisher exact tests|||||<|0.05|||||||Fisher Exact|||Differences in cancer survivorship performance indicators and surveillance rates by tumor types before and after intervention were assessed using Fisher Exact tests.||||<0.05
91754106|NCT04763824|183401340|OTHER|Fisher exact test|||||<|0.05|||||||Fisher Exact|||Differences in cancer survivorship performance indicators and surveillance rates by tumor types before and after intervention were assessed using Fisher Exact tests.||||<0.05
91754107|NCT04763824|183401342|OTHER|Fisher exact test|||||<|0.05|||||||Fisher Exact|||Differences in cancer survivorship performance indicators and surveillance rates by tumor types before and after intervention were assessed using Fisher Exact tests.||||<0.05
91508356|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5111|TWO_SIDED|95.0|-0.39|0.2|||MMRM|||Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.39|0.5111
91508357|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.155||0.5839|TWO_SIDED|95.0|-0.39|0.22|||MMRM|||Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.39|0.5839
91508358|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1905|TWO_SIDED|95.0|-0.33|0.07|||MMRM|||Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.33|0.1905
91754108|NCT04763824|183401344|OTHER|Fisher exact test|||||<|0.05|||||||Fisher Exact|||Differences in cancer survivorship performance indicators and surveillance rates by tumor types before and after intervention were assessed using Fisher Exact tests.||||<0.05
91754109|NCT05579249|183401415|SUPERIORITY||Odds Ratio (OR)|3.18|||<|0.0001|TWO_SIDED|95.0|2.12|4.78|||Regression, Linear|||Week 52 responses were analysed using a binary regression model with randomized treatment as factor and baseline body weight as covariate.||4.78|2.12|<0.0001
91754110|NCT05028517|183401424|SUPERIORITY||ANOVA Omnibus F test|0.511||||0.602|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.602
91754111|NCT05028517|183401424|SUPERIORITY||Cohen's d|-0.22||||0.33|TWO_SIDED|95.0|-0.69|0.23||False discovery rate (FDR) correction for multiple comparisons, p=.334.|Regression, Linear|||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. Baseline and FMF Connect group status were entered into the regression model simultaneously. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.||0.23|-0.69|.33
91754112|NCT05028517|183401425|SUPERIORITY||ANOVA Omnibus F test|1.245||||0.294|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.294
91754113|NCT05028517|183401425|SUPERIORITY|||||||0.524||||||False discovery rate (FDR) correction for multiple comparisons, p=.602|Mixed Models Analysis|F(2) = .652||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data in SPSS. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.524
91754114|NCT05028517|183401426|SUPERIORITY||Anova Omnibus F test|2.585||||0.039|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.039
91754115|NCT05028517|183401426|SUPERIORITY|||||||0.548||||||False discovery rate (FDR) correction for multiple comparisons, p=.893|Mixed Models Analysis|F(2) = .606||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.548
91754116|NCT05028517|183401427|SUPERIORITY||Anova Omnibus F test|2.723||||0.032|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||0.032
91754117|NCT05028517|183401427|SUPERIORITY|||||||0.013||||||False discovery rate (FDR) correction for multiple comparisons, p=.143|Mixed Models Analysis|F(2) = 4.595||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.013
91754118|NCT05028517|183401428|SUPERIORITY||Anova Omnibus F test|0.588||||0.672|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||0.672
91754119|NCT05028517|183401428|SUPERIORITY|||||||0.463||||||False discovery rate (FDR) correction for multiple comparisons, p=.893|Mixed Models Analysis|F(2) = .776||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.463
91754120|NCT05028517|183401429|SUPERIORITY||Anova Omnibus F test|2.612||||0.038|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||0.038
91508359|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.1767|TWO_SIDED|95.0|-0.54|0.1|||MMRM|||Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.54|0.1767
91532772|NCT00783718|182942362|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.1||||0.0012||95.0|6.4|25.9||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||25.9|6.4|0.0012
91532773|NCT00783718|182942363|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.8|||<|0.0001|TWO_SIDED|95.0|20.8|44.7||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||44.7|20.8|< 0.0001
91508360|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5182|TWO_SIDED|95.0|-0.47|0.24|||MMRM|||Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.47|0.5182
91754121|NCT05028517|183401429|SUPERIORITY|||||||0.084||||||False discovery rate (FDR) correction for multiple comparisons, p=.462|Mixed Models Analysis|F(2) = 2.544||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.084
91754122|NCT05028517|183401430|SUPERIORITY||Anova Omnibus F test|0.196||||0.94|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.940
91759619|NCT05362058|183411931|SUPERIORITY||LS Mean Difference|-0.35||||0.701|TWO_SIDED|95.0|-2.15|1.44|||Mixed Models Analysis|||EQ VAS Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.44|-2.15|0.701
91759620|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||||TWO_SIDED|60.0|5.0|15.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||15|5|
91759621|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.0|||||TWO_SIDED|60.0|18.0|31.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||31|18|
91759622|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0|||||TWO_SIDED|60.0|25.0|39.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||39|25|
91759623|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|36.0|||||TWO_SIDED|60.0|29.0|43.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||43|29|
91759624|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||||TWO_SIDED|60.0|6.0|22.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||22|6|
91508361|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.185||0.393|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3930
91759625|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.0|||||TWO_SIDED|60.0|27.0|42.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||42|27|
91759626|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.0|||||TWO_SIDED|60.0|-32.0|-17.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-17|-32|
91759627|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|||||TWO_SIDED|60.0|-16.0|-4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-4|-16|
91759628|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|60.0|-9.0|4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||4|-9|
91759629|NCT01393639|183411974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|60.0|-5.0|8.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||8|-5|
91754123|NCT05028517|183401430|SUPERIORITY|||||||0.961||||||False discovery rate (FDR) correction for multiple comparisons, p=.961|Mixed Models Analysis|F(2) = .040||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.961
91754124|NCT05028517|183401431|SUPERIORITY||Anova Omnibus F test|0.59||||0.671|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.671
91759630|NCT01393639|183411975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64|||||TWO_SIDED|95.0|-13.75|17.03|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||17.03|-13.75|
91759631|NCT01393639|183411975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.71|||||TWO_SIDED|90.0|-22.16|8.75|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||8.75|-22.16|
91759632|NCT01393639|183411975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|90.0|-20.45|10.3|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||10.30|-20.45|
91759633|NCT01393639|183411975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.74|||||TWO_SIDED|90.0|-27.19|3.72|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||3.72|-27.19|
91759634|NCT01393639|183411976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-12.92|19.61|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||19.61|-12.92|
91759635|NCT01393639|183411976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.52|||||TWO_SIDED|90.0|-22.86|9.81|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||9.81|-22.86|
91759636|NCT01393639|183411976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|90.0|-12.11|20.55|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||20.55|-12.11|
91759637|NCT01393639|183411976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.83|||||TWO_SIDED|90.0|-3.49|29.15|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||29.15|-3.49|
91759638|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|11.36|||||TWO_SIDED|95.0|-6.84|29.56|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||29.56|-6.84|
91759639|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.15|||||TWO_SIDED|95.0|-5.88|30.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||30.19|-5.88|
91759640|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.54|||||TWO_SIDED|95.0|0.91|38.17|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||38.17|0.91|
91759641|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.09|||||TWO_SIDED|95.0|3.6|40.58|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||40.58|3.60|
91759642|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.43|||||TWO_SIDED|95.0|-9.38|26.25|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.25|-9.38|
91759643|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.5|||||TWO_SIDED|95.0|-1.84|34.84|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||34.84|-1.84|
91759644|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.88|||||TWO_SIDED|95.0|-28.58|10.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.80|-28.58|
91759645|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.31|||||TWO_SIDED|95.0|-4.85|35.49|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.49|-4.85|
91759646|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.66|||||TWO_SIDED|95.0|6.8|46.53|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||46.53|6.80|
91759647|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.19|||||TWO_SIDED|95.0|-7.01|33.4|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||33.40|-7.01|
91759648|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-11.56|29.33|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||29.33|-11.56|
91759649|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.21|||||TWO_SIDED|95.0|5.35|45.07|||||Non-responder imputation was used to handle dropouts.|Week 4 comparisons presented in this section for comparison to placebo.||45.07|5.35|
91759650|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-17.4|21.85|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||21.85|-17.40|
91759651|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.6|||||TWO_SIDED|95.0|-4.24|35.45|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.45|-4.24|
91508362|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.189||0.5212|TWO_SIDED|95.0|-0.5|0.25|||MMRM|||Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.50|0.5212
91508363|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.184||0.4741|TWO_SIDED|95.0|-0.5|0.23|||MMRM|||Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.50|0.4741
91754125|NCT05028517|183401431|SUPERIORITY|||||||0.19||||||False discovery rate (FDR) correction for multiple comparisons, p=.523|Mixed Models Analysis|F(2)=1.696||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.190
91754126|NCT05028517|183401432|SUPERIORITY||Anova Omnibus F test|0.896||||0.468|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.468
91754127|NCT05028517|183401432|SUPERIORITY|||||||0.683||||||False discovery rate (FDR) correction for multiple comparisons, p=.817|Mixed Models Analysis|F(2) = .384||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.683
91754128|NCT05028517|183401433|SUPERIORITY||Anova Omnibus F test|3.42||||0.01|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||0.01
91754129|NCT05028517|183401433|SUPERIORITY|||||||0.131||||||False discovery rate (FDR) correction for multiple comparisons, p=.480|Mixed Models Analysis|F(2)=2.081||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.||||.131
91754130|NCT05028517|183401434|SUPERIORITY||Anova Omnibus F test|1.384||||0.257|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.257
91754131|NCT05028517|183401434|SUPERIORITY||Cohen's d|0.49||||0.039|TWO_SIDED|95.0|-0.02|0.94||False discovery rate (FDR) correction for multiple comparisons, p=.055|Regression, Linear|||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. Baseline and FMF Connect group status were entered into the regression model simultaneously. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.||0.94|-0.02|.039
91754132|NCT05028517|183401435|SUPERIORITY||Anova Omnibus F test|1.686||||0.192|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.192
91754133|NCT05028517|183401435|SUPERIORITY||Cohen's d|0.47||||0.039|TWO_SIDED|95.0|0.02|0.93||False discovery rate (FDR) correction for multiple comparisons, p=.055|Regression, Linear|||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. Baseline and FMF Connect group status were entered into the regression model simultaneously. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.||0.93|0.02|.039
91754134|NCT05028517|183401436|SUPERIORITY||Anova Omnibus F test|0.651||||0.524|TWO_SIDED||||||ANOVA|||Mean comparisons of 3 separate groups using ANOVA for 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.||||.524
91754135|NCT05028517|183401436|SUPERIORITY||Cohen's d|0.46||||0.048|TWO_SIDED|95.0|0.0|0.91||False discovery rate (FDR) correction for multiple comparisons, p=.066|Regression, Linear|||The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.||0.91|0.00|.048
91754136|NCT05028517|183401437|SUPERIORITY||Anova Omnibus F test|1.32||||0.255|TWO_SIDED||||||ANOVA|||||||.255
91754137|NCT01280695|183401444|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.0||||0.4195|TWO_SIDED|95.0|-34.0|14.0|||Wilcoxon (Mann-Whitney)|||||14.0|-34.0|0.4195
91754138|NCT01280695|183401444|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.0||||0.0811|TWO_SIDED|95.0|-38.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-38.0|0.0811
91754139|NCT01280695|183401444|SUPERIORITY_OR_OTHER||Median Difference (Net)|-20.0||||0.0639|TWO_SIDED|95.0|-38.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-38.0|0.0639
91754140|NCT01280695|183401444|SUPERIORITY_OR_OTHER||Median Difference (Net)|-32.0||||0.0022|TWO_SIDED|95.0|-50.0|-12.0|||Wilcoxon (Mann-Whitney)|||||-12.0|-50.0|0.0022
91754141|NCT01216683|183401450|SUPERIORITY|||||||0.02||||||one-sided p-value|Cochran-Mantel-Haenszel|||The study was designed to detect a 16% difference in CR rate from 50% in the Bendamustine + Rituximab arms to 66% in the Bendamustine + Rituximab + Bortezomib arm, with 90% power at the one-sided alpha 0.15 level.||||0.02
91754142|NCT01216683|183401451|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index||||||0.02
91508364|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.186||0.4482|TWO_SIDED|95.0|-0.51|0.23|||MMRM|||Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.51|0.4482
91508365|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.187||0.0963|TWO_SIDED|95.0|-0.69|0.06|||MMRM|||Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.69|0.0963
91508366|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.171||0.003|TWO_SIDED|95.0|-0.86|-0.18|||MMRM|||Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.18|-0.86|0.0030
91508367|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.177||0.1116|TWO_SIDED|95.0|-0.63|0.07|||MMRM|||Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.63|0.1116
91508368|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.173||0.004|TWO_SIDED|95.0|-0.86|-0.17|||MMRM|||Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-0.86|0.0040
91508369|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.244||0.8253|TWO_SIDED|95.0|-0.54|0.43|||MMRM|||Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.54|0.8253
91508370|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.209||0.5795|TWO_SIDED|95.0|-0.3|0.53|||MMRM|||Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.30|0.5795
91754143|NCT04327024|183401478|OTHER||Mean Difference (Final Values)|-0.1||||0.862|TWO_SIDED|95.0|-1.28|1.08|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.08|-1.28|0.862
91754144|NCT04327024|183401479|OTHER||Mean Difference (Final Values)|0.44||||0.472|TWO_SIDED|95.0|-0.76|1.64|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.64|-0.76|0.472
91508371|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.182||0.4032|TWO_SIDED|95.0|-0.21|0.51|||MMRM|||Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|-0.21|0.4032
91754145|NCT04327024|183401480|OTHER||Mean Difference (Final Values)|3.15||||0.287|TWO_SIDED|95.0|-2.65|8.94|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||8.94|-2.65|0.287
91508372|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.133||0.6117|TWO_SIDED|95.0|-0.33|0.2|||MMRM|||Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.33|0.6117
91508373|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4716|TWO_SIDED|95.0|-0.35|0.16|||MMRM|||Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.35|0.4716
91759652|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.22|||||TWO_SIDED|95.0|2.2|42.23|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||42.23|2.20|
91508374|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.136||0.6041|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.6041
91508375|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.132||0.0424|TWO_SIDED|95.0|-0.53|-0.01|||MMRM|||Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.53|0.0424
91508376|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.138||0.7622|TWO_SIDED|95.0|-0.32|0.23|||MMRM|||Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.32|0.7622
91532774|NCT00783718|182942363|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.5|||<|0.0001|TWO_SIDED|95.0|16.7|40.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||40.3|16.7|< 0.0001
91754146|NCT04327024|183401481|OTHER||Mean Difference (Final Values)|-0.15||||0.96|TWO_SIDED|95.0|-5.9|5.61|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||5.61|-5.90|0.960
91754147|NCT03968159|183401483|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.82||0.2956|TWO_SIDED|95.0|-2.5|0.8|||Mixed-effects model for repeated measure|||||0.8|-2.5|0.2956
91508377|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2689|TWO_SIDED|95.0|-0.4|0.11|||MMRM|||Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.40|0.2689
91754148|NCT00443781|183401502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||McNemar|Exact test was used.||Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.||||0.002
91508378|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.134||0.211|TWO_SIDED|95.0|-0.44|0.1|||MMRM|||Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.44|0.2110
91508379|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.135||0.5873|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.5873
91508380|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.114||0.045|TWO_SIDED|95.0|-0.46|-0.01|||MMRM|||Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.46|0.0450
91508381|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.152||0.0847|TWO_SIDED|95.0|-0.57|0.04|||MMRM|||Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.57|0.0847
91508382|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.189||0.2522|TWO_SIDED|95.0|-0.16|0.6|||MMRM|||Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.60|-0.16|0.2522
91754149|NCT01533922|183401505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.191|0.298|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 once daily (QD) minus Placebo|||0.298|0.191|<0.0001
91754150|NCT01533922|183401505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.065|0.172|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg|||0.172|0.065|<0.0001
91754151|NCT01533922|183401505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.061|0.167|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.167|0.061|<0.0001
91754152|NCT01533922|183401505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.164|0.271|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.271|0.164|<0.0001
91508383|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.5026|TWO_SIDED|95.0|-0.43|0.21|||MMRM|||Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.43|0.5026
91754153|NCT01533922|183401505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.027||0.0008|TWO_SIDED|95.0|0.038|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.038|0.0008
91754154|NCT01533922|183401505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.034|0.141|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.141|0.034|0.0015
91754155|NCT01533922|183401506|SUPERIORITY_OR_OTHER||Ratio|1.209|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|1.132|1.292|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.292|1.132|<0.0001
91754156|NCT01533922|183401506|SUPERIORITY_OR_OTHER||Ratio|1.002|STANDARD_ERROR_OF_MEAN|0.034||0.9633|TWO_SIDED|95.0|0.937|1.07|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Olodaterol 5 mcg QD|||1.070|0.937|0.9633
91754157|NCT01533922|183401506|SUPERIORITY_OR_OTHER||Ratio|0.993|STANDARD_ERROR_OF_MEAN|0.033||0.8415|TWO_SIDED|95.0|0.93|1.061|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.061|0.930|0.8415
91754158|NCT01533922|183401506|SUPERIORITY_OR_OTHER||Ratio|1.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|1.184|1.351|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.351|1.184|<0.0001
91754159|NCT01533922|183401506|SUPERIORITY_OR_OTHER||Ratio|1.047|STANDARD_ERROR_OF_MEAN|0.035||0.1717|TWO_SIDED|95.0|0.98|1.119|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.119|0.980|0.1717
91754160|NCT01533922|183401506|SUPERIORITY_OR_OTHER||Ratio|1.039|STANDARD_ERROR_OF_MEAN|0.035||0.261|TWO_SIDED|95.0|0.972|1.11|||Mixed Models Analysis||Ratio calculated asTiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.110|0.972|0.2610
91754161|NCT01533922|183401507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0004|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.001|-0.004|0.0004
91754162|NCT01533922|183401507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.8291|TWO_SIDED|95.0|-0.001|0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.002|-0.001|0.8291
91754163|NCT01533922|183401507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.857|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.8570
91754164|NCT01533922|183401507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
91754165|NCT01533922|183401507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.7294|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.001|-0.002|0.7294
91754166|NCT01533922|183401507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.4567|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.4567
91754167|NCT01533922|183401508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.352|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.352|0.293|<0.0001
91754168|NCT01533922|183401508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.16|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.160|0.101|<0.0001
91754169|NCT01533922|183401508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.084|0.143|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.143|0.084|<0.0001
91754170|NCT01533922|183401508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.256|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.315|0.256|<0.0001
91754171|NCT01533922|183401508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.123|0.063|<0.0001
91754172|NCT01533922|183401508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.047|0.106|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.106|0.047|<0.0001
91754173|NCT01302054|183401550|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-2.63|-2.02||Statistical testing: one-sided, at alpha = 0.025.|t-test, 1 sided|||||-2.02|-2.63|<0.0001
91754174|NCT01302054|183401551|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0079|TWO_SIDED|95.0|-0.87|-0.13||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance \[ANCOVA\]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).||-0.13|-0.87|0.0079
91754175|NCT01302054|183401552|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0931|TWO_SIDED|95.0|-0.86|0.07||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||0.07|-0.86|0.0931
91754176|NCT01302054|183401553|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0438|TWO_SIDED|95.0|-1.37|-0.02||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-0.02|-1.37|0.0438
91754177|NCT01302054|183401554|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||<0.0001
91754178|NCT01302054|183401555|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||0.0095
91754179|NCT01302054|183401556|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.34|STANDARD_ERROR_OF_MEAN|1.91||0.0001|TWO_SIDED|95.0|-11.1|-3.58||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-3.58|-11.10|0.0001
91754180|NCT01302054|183401557|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|9.01|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|5.12|12.91||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||12.91|5.12|<0.0001
91754181|NCT01302054|183401557|SUPERIORITY_OR_OTHER||LS Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|3.87|11.62||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||11.62|3.87|<0.0001
91754182|NCT01302054|183401557|SUPERIORITY_OR_OTHER||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|2.0||0.0012|TWO_SIDED|95.0|2.6|10.45||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.45|2.60|0.0012
91535620|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|2.45||0.1746|TWO_SIDED|95.0|-8.21|1.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.51|-8.21|0.1746
91754183|NCT01302054|183401557|SUPERIORITY_OR_OTHER||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|1.64||0.0123|TWO_SIDED|95.0|0.9|7.36||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||7.36|0.90|0.0123
91754184|NCT01302054|183401557|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|3.63|10.57||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.57|3.63|<0.0001
91754185|NCT01302054|183401558|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0023
91754186|NCT01302054|183401559|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0027
91754187|NCT01302054|183401560|SUPERIORITY_OR_OTHER|||||||0.0427|TWO_SIDED|||||Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0427
91754188|NCT01302054|183401560|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED|||||Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.1461
91754189|NCT02639338|183401561|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|Binomial Test|||||||<0.001
91754190|NCT02639338|183401561|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|2-sided exact 1-sample binomial test|||||||<0.001
91754191|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||||90.0|-3.8|1.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.59|-3.80|
91754192|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||||90.0|-3.55|-0.31|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.31|-3.55|
91754193|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||||90.0|-7.69|-2.3|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.30|-7.69|
91754194|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-4.58|-1.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.34|-4.58|
91754195|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88||||||90.0|-7.58|-2.19|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.19|-7.58|
91754196|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||||90.0|-5.44|-2.2|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.20|-5.44|
91754197|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-4.74|0.64|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.64|-4.74|
91754198|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||||90.0|-3.38|-0.15|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.15|-3.38|
91759653|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.96|||||TWO_SIDED|95.0|-14.6|24.53|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||24.53|-14.60|
91754199|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||||90.0|-4.77|0.62|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.62|-4.77|
91754200|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||||90.0|-2.49|0.74|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.74|-2.49|
91754201|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-4.99|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-4.99|
91532775|NCT00783718|182942364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.0|||<|0.0001|TWO_SIDED|95.0|20.3|43.8||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||43.8|20.3|< 0.0001
91754202|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||||90.0|-2.47|0.77|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.77|-2.47|
91754203|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22||||||90.0|-6.91|-1.52|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.52|-6.91|
91754204|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51||||||90.0|-4.13|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-4.13|
91754205|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||||90.0|-4.63|0.76|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.76|-4.63|
91754206|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32||||||90.0|-3.94|-0.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.70|-3.94|
91754207|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||||90.0|-8.22|-0.5|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.50|-8.22|
91754208|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||||90.0|-6.29|-1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.56|-6.29|
91754209|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||||90.0|-10.77|-3.05|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.05|-10.77|
91754210|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79||||||90.0|-8.15|-3.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.42|-8.15|
91754211|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8||||||90.0|-9.66|-1.94|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.94|-9.66|
91754212|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.65||||||90.0|-9.01|-4.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-4.29|-9.01|
91754213|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27||||||90.0|-8.13|-0.41|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.41|-8.13|
91754214|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||||90.0|-6.01|-1.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.29|-6.01|
91508384|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.149||0.5911|TWO_SIDED|95.0|-0.38|0.22|||MMRM|||Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.38|0.5911
91508385|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122||0.58|TWO_SIDED|95.0|-0.18|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.18|0.5800
91508386|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.129||0.6754|TWO_SIDED|95.0|-0.31|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.31|0.6754
91508387|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.116||0.1006|TWO_SIDED|95.0|-0.04|0.42|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.04|0.1006
91508388|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.3588|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3588
91532776|NCT00783718|182942364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.3|||<|0.0001|TWO_SIDED|95.0|24.4|48.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||48.3|24.4|< 0.0001
91754215|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-5.91|1.81|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.81|-5.91|
91754216|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||||90.0|-3.46|1.27|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.27|-3.46|
91754217|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-6.16|1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.56|-6.16|
91754218|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||||90.0|-5.79|-1.06|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.06|-5.79|
91508389|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.109||0.5807|TWO_SIDED|95.0|-0.28|0.16|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.28|0.5807
91508390|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.112||0.4241|TWO_SIDED|95.0|-0.13|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.13|0.4241
91508391|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7984|TWO_SIDED|95.0|-0.26|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.26|0.7984
91508392|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.122||0.8732|TWO_SIDED|95.0|-0.22|0.26|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.22|0.8732
91754219|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||||90.0|-7.33|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-7.33|
91754220|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.26||||||90.0|-5.62|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-5.62|
91754221|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||||90.0|-4.13|3.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||3.59|-4.13|
91754222|NCT00853840|183401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26||||||90.0|-4.62|0.1|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.10|-4.62|
91754223|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95||||||90.0|4.18|9.72|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||9.72|4.18|
91754224|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51||||||90.0|2.73|8.28|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.28|2.73|
91754225|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.64||||||90.0|0.87|6.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.42|0.87|
91754226|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||||90.0|0.12|5.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||5.67|0.12|
91754227|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||||90.0|-0.71|4.83|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||4.83|-0.71|
91754228|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||||90.0|2.68|8.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.22|2.68|
91754229|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||||90.0|1.34|6.89|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.89|1.34|
91754230|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.45||||||90.0|0.68|6.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.22|0.68|
91754231|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33||||||90.0|3.7|10.95|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.95|3.70|
91754232|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|3.2|10.45|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.45|3.20|
91754233|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.02||||||90.0|1.4|8.65|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.65|1.40|
91754234|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.72||||||90.0|1.09|8.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.34|1.09|
91754235|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05||||||90.0|0.43|7.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||7.67|0.43|
91754236|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||||90.0|2.73|9.98|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||9.98|2.73|
91754237|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.08||||||90.0|1.45|8.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.70|1.45|
91754238|NCT00853840|183401571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||||90.0|-1.74|5.51|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||5.51|-1.74|
91754239|NCT02725593|183401575|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.45||0.101|TWO_SIDED|95.0|-1.65|0.15|||Mixed model repeated measures analysis|||||0.15|-1.65|0.101
91754240|NCT02725593|183401576|SUPERIORITY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.81||0.34|TWO_SIDED|95.0|-2.42|0.85|||Mixed model repeated measures analysis|||||0.85|-2.42|0.340
91754241|NCT02725593|183401577|SUPERIORITY||Mean Difference (Final Values)|-3.96||||0.655|TWO_SIDED|95.0|-20.11|9.62|||Fisher's exact test|||||9.62|-20.11|0.655
91754242|NCT02725593|183401578|SUPERIORITY||Mean Difference (Final Values)|20.83||||0.056|TWO_SIDED|95.0|0.5|41.11|||Fisher's exact test|||||41.11|0.50|0.056
91754243|NCT03689244|183401579|SUPERIORITY||Ratio of Geometric LS mean|0.95||||0.412|TWO_SIDED|95.0|0.84|1.07|||ANCOVA|||Ratio of Geometric mean of Selexipag to Placebo was reported.||1.07|0.84|0.412
91754244|NCT01355796|183401583|SUPERIORITY||Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|95.0|-1.76|4.75|||Mixed Models Analysis|||||4.75|-1.76|<0.05
91754245|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.52|
91754246|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.52|
91754247|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.51|5.02||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.51|
91754248|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|4.17|||||TWO_SIDED|95.0|1.37|11.57||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||11.57|1.37|
91759654|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-4.51|35.63|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.63|-4.51|
91759655|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|23.18|||||TWO_SIDED|95.0|3.31|43.06|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||43.06|3.31|
91759656|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-5.13|||||TWO_SIDED|95.0|-24.73|14.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||14.45|-24.73|
91759657|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-23.79|15.09|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||15.09|-23.79|
91759658|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
91759659|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
91759660|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-34.1|||||TWO_SIDED|95.0|-53.4|-14.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-14.80|-53.40|
91508393|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.107||0.8621|TWO_SIDED|95.0|-0.19|0.23|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.19|0.8621
91508394|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.126||0.1087|TWO_SIDED|95.0|-0.45|0.05|||MMRM|||Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.45|0.1087
91508395|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.125||0.2153|TWO_SIDED|95.0|-0.41|0.09|||MMRM|||Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.41|0.2153
91508396|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.145||0.1422|TWO_SIDED|95.0|-0.51|0.07|||MMRM|||Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.51|0.1422
91508397|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7211|TWO_SIDED|95.0|-0.19|0.27|||MMRM|||Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.19|0.7211
91532777|NCT00783718|182942365|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.8||||0.0079|TWO_SIDED|95.0|3.1|20.5||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||20.5|3.1|0.0079
91754249|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.46|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.46|
91508398|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8224|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.18|0.8224
91754250|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.48|
91754251|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.02||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.48|
91754252|NCT00969436|183401614|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|2.77|||||TWO_SIDED|95.0|-1.59|10.29||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||10.29|-1.59|
91754253|NCT00351273|183401623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.8||||0.01|TWO_SIDED||||||Fisher Exact|||Difference in the percentages of participants with response between all those who received combination therapy vs. placebo||||0.01
91508399|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6362|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6362
91754254|NCT01672866|183401631|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.2|||||TWO_SIDED|95.0|-1.3|1.0||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.0|-1.3|
91754255|NCT01672866|183401631|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.4|||||TWO_SIDED|95.0|-1.5|0.8||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||0.8|-1.5|
91754256|NCT01672866|183401632|SUPERIORITY|||||||0.73|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.73
91754257|NCT01672866|183401632|SUPERIORITY|||||||0.85|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.85
91754258|NCT01018095|183401633|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.191||0.045|TWO_SIDED|95.0|0.25|1.0|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||1.00|0.25|.045
91754259|NCT01018095|183401633|NON_INFERIORITY_OR_EQUIVALENCE|It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.|Risk Ratio (RR)|0.46|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.21|0.98||Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.|Chi-squared|||||0.98|0.21|<0.05
91754260|NCT01018095|183401634|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.46|STANDARD_ERROR_OF_MEAN|0.196|=|0.03|TWO_SIDED|95.0|0.21|0.98|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||0.98|.21|=0.03
91754261|NCT05714943|183401635|SUPERIORITY|||||||0.99|||||||Regression, Linear|||||||.99
91754262|NCT05714943|183401636|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
91754263|NCT05714943|183401637|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||.09
91754264|NCT05714943|183401638|SUPERIORITY|||||||0.57|||||||Regression, Linear|||||||.57
91754265|NCT05714943|183401639|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
91754266|NCT05714943|183401640|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
91754267|NCT05714943|183401641|SUPERIORITY|||||||0.97|||||||Regression, Linear|||||||.97
91754268|NCT05714943|183401642|SUPERIORITY|||||||0.21|||||||Regression, Linear|||||||.21
91754269|NCT05714943|183401643|SUPERIORITY|||||||0.27|||||||Regression, Linear|||||||.27
91754270|NCT05714943|183401644|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
91754271|NCT05714943|183401645|SUPERIORITY|||||||0.86|||||||Regression, Linear|||||||.86
91754272|NCT05714943|183401646|SUPERIORITY|||||||0.61|||||||Regression, Linear|||||||.61
91754273|NCT05714943|183401647|SUPERIORITY|||||||0.02|||||||Regression, Linear|||||||.02
91754274|NCT05714943|183401648|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
91754275|NCT05714943|183401649|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
91754276|NCT05714943|183401650|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||.06
91754277|NCT05714943|183401651|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
91754278|NCT05714943|183401652|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||.88
91754279|NCT05714943|183401653|SUPERIORITY|||||||0.94|||||||Regression, Linear|||||||.94
91759661|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.89|||||TWO_SIDED|95.0|-29.68|9.88|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||9.88|-29.68|
91759662|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.44|||||TWO_SIDED|95.0|-18.02|20.92|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||20.92|-18.02|
91759663|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.02|||||TWO_SIDED|95.0|-31.84|7.79|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||7.79|-31.84|
91754280|NCT01122108|183401654|SUPERIORITY_OR_OTHER||||||<|0.05||||||If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.|repeated measures analysis of variance|Sensitivity analyses were run to evaluate possible product by sequence interactions||"The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed."||||<0.05
91754281|NCT01595581|183401674|OTHER|Mann-Whitney U test for continuous variables and Fisher exact test for categorical variables|Mean Difference (Net)|2.9|STANDARD_DEVIATION|1.5||0.35|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 6 weeks post operative."||||0.35
91754282|NCT01595581|183401674|OTHER||Mean Difference (Net)|2.17|STANDARD_DEVIATION|2.0||0.48|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 12 weeks post operative."||||0.48
91754283|NCT01595581|183401674|OTHER||Mean Difference (Net)|1.08|STANDARD_DEVIATION|15.0||0.74|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 24 weeks post operative."||||0.74
91754284|NCT01969721|183401677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.103|0.147||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.147|0.103|<0.0001
91754285|NCT01969721|183401677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.129|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.107|0.15||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.150|0.107|<0.0001
91754286|NCT01969721|183401677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.081|0.124||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.124|0.081|<0.0001
91754287|NCT01969721|183401677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.085|0.128||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.128|0.085|<0.0001
91754288|NCT01969721|183401678|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.061|0.103||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.103|0.061|<0.0001
91759664|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-20.96|||||TWO_SIDED|95.0|-40.98|-0.94|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||-0.94|-40.98|
91532778|NCT00783718|182942365|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0009|TWO_SIDED|95.0|6.2|24.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||24.4|6.2|0.0009
91754289|NCT01969721|183401678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.065|0.107||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.107|0.065|<0.0001
91754290|NCT01969721|183401678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.045|0.086||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.086|0.045|<0.0001
91754291|NCT01969721|183401678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.048|0.09||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.090|0.048|<0.0001
91754292|NCT01969721|183401679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.071|0.022|0.0002
91754293|NCT01969721|183401679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.082|0.034|<0.0001
91754294|NCT01969721|183401679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.018|0.067||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.067|0.018|0.0007
91754295|NCT01969721|183401679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.029|0.078||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.078|0.029|<0.0001
91759665|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.58|||||TWO_SIDED|95.0|-27.82|12.65|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||12.65|-27.82|
91759666|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.96|||||TWO_SIDED|95.0|-21.36|19.43|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||19.43|-21.36|
91759667|NCT01393639|183411977|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-18.22|||||TWO_SIDED|95.0|-38.18|1.73|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||1.73|-38.18|
91532779|NCT00783718|182942366|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.6||||0.012|TWO_SIDED|95.0|3.9|31.3||P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||31.3|3.9|0.0120
91754296|NCT01969721|183401680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.017|0.062||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.062|0.017|0.0007
91754297|NCT01969721|183401680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043|STANDARD_ERROR_OF_MEAN|0.011||0.0002|TWO_SIDED|95.0|0.021|0.065||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.065|0.021|0.0002
91754298|NCT01969721|183401680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.011||0.0146|TWO_SIDED|95.0|0.006|0.051||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.051|0.006|0.0146
91759668|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.27|||||TWO_SIDED|95.0|-11.93|7.38|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||7.38|-11.93|
91759669|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.87|||||TWO_SIDED|95.0|-9.15|12.91|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||12.91|-9.15|
91759670|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.07|||||TWO_SIDED|95.0|-9.09|13.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.23|-9.09|
91759671|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.71|||||TWO_SIDED|95.0|4.19|33.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||33.23|4.19|
91759672|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.59|||||TWO_SIDED|95.0|-13.19|4.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||4.00|-13.19|
91759673|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.74|||||TWO_SIDED|95.0|-0.92|26.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.41|-0.92|
91759674|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.16|-14.60|
91759675|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.29|||||TWO_SIDED|95.0|-2.9|27.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.48|-2.90|
91759676|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|7.71|41.17|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||41.17|7.71|
91759677|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.54|||||TWO_SIDED|95.0|0.8|32.29|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||32.29|0.80|
91759678|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.98|12.98|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||12.98|-12.98|
91759679|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.32|||||TWO_SIDED|95.0|3.16|35.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.48|3.16|
91759680|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-18.46|9.57|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||9.57|-18.46|
91759681|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.1|||||TWO_SIDED|95.0|-4.49|28.7|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||28.70|-4.49|
91754299|NCT01969721|183401680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.011||0.0055|TWO_SIDED|95.0|0.009|0.054||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.054|0.009|0.0055
91754300|NCT01969721|183401681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.118|0.166||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.166|0.118|<0.0001
91754301|NCT01969721|183401681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.123|0.171||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.171|0.123|<0.0001
91754302|NCT01969721|183401681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.135|0.087|<0.0001
91508400|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6094|TWO_SIDED|95.0|-0.31|0.18|||MMRM|||Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.31|0.6094
91532780|NCT00783718|182942366|SUPERIORITY_OR_OTHER||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|16.6|46.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||46.2|16.6|< 0.0001
91754303|NCT01969721|183401681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.092|0.14||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.140|0.092|<0.0001
91754304|NCT01058941|183401685|OTHER||Mean Difference (Net)|-0.42||||0.82|TWO_SIDED|95.0|-3.97|3.13||We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||3.13|-3.97|0.82
91754305|NCT01058941|183401686|OTHER||Mean Difference (Net)|-3.68||||0.001|TWO_SIDED|95.0|-5.9|-1.46||We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||-1.46|-5.90|0.001
91754306|NCT03159104|183401714|SUPERIORITY||Median Difference (Final Values)|5.0||||0.0113|TWO_SIDED|95.0|1.0|9.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|The difference between final and initial total scholastic skill score was calculated for each participant. Wilcoxon test was used for comparison of these differences because data distribution differs from normal.||9|1|0.0113
91754307|NCT03159104|183401715|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0608|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||5|0|0.0608
91754308|NCT03159104|183401716|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0824|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||0|0|0.0824
91754309|NCT03159104|183401717|SUPERIORITY||Median Difference (Final Values)|0.0||||0.2391|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||1|0|0.2391
91754310|NCT03159104|183401718|SUPERIORITY|||||||0.0033|||||||Fisher Exact|||||||0.0033
91754311|NCT03159104|183401719|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||||||0.0012
91754312|NCT01294163|183401720|NON_INFERIORITY_OR_EQUIVALENCE|Xenon was to be concluded non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the prespecified margin of 0.63 ng/mL. Assuming a margin of 0.63, a same concentration of troponin I at 24 hours in the xenon and sevoflurane groups, a common standard deviation of 1.9 ng/mL and a one-sided type I error of 0.025, 164 patients per group were deemed necessary to demonstrate non-inferiority.|Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-1.27|0.47|||ANCOVA|Treatment difference and 95%CI assessed using ANCOVA with 24h troponin I as response, treatment group and pre-induction troponin I as covariates.||||0.47|-1.27|0.02
91754313|NCT01294163|183401729|NON_INFERIORITY_OR_EQUIVALENCE|It was to be concluded that xenon was non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the margin of 0.15 ng/mL.|Mean Difference (Final Values)|-0.09||||0.0186|TWO_SIDED|95.0|-0.3|0.11|||ANCOVA|||As the residuals from the primary ANCOVA model were non-normal and skewed, the non-inferiority analysis was repeated using log-transformed blood troponin levels.||0.11|-0.30|0.0186
91754314|NCT01563172|183401730|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|6.95||||0.0008|TWO_SIDED|95.0|2.91|10.98||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||10.98|2.91|0.0008
91508401|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.123||0.0457|TWO_SIDED|95.0|-0.49|0.0|||MMRM|||Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.49|0.0457
91754315|NCT01563172|183401731|SUPERIORITY_OR_OTHER||LS mean difference|5.7||||0.0049|TWO_SIDED|95.0|1.74|9.66||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||9.66|1.74|0.0049
91508402|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5691|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5691
91754316|NCT01563172|183401732|SUPERIORITY_OR_OTHER||LS mean difference|-10.86|||<|0.0001|TWO_SIDED|95.0|-14.77|-6.94||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-6.94|-14.77|<0.0001
91754317|NCT01563172|183401733|SUPERIORITY_OR_OTHER||LS mean difference|-9.61|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.54||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-5.54|-13.68|<0.0001
91754318|NCT01563172|183401734|SUPERIORITY_OR_OTHER||LS mean difference|15.38|||<|0.0001|TWO_SIDED|95.0|11.45|19.31||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||19.31|11.45|<0.0001
91754319|NCT01563172|183401735|SUPERIORITY_OR_OTHER||LS Mean Difference|514.01|||<|0.0001|TWO_SIDED|95.0|283.02|744.99||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||744.99|283.02|<0.0001
91754320|NCT01563172|183401736|SUPERIORITY_OR_OTHER||LS Mean difference|265.92||||0.0218|TWO_SIDED|95.0|39.0|492.83||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||492.83|39.00|0.0218
91754321|NCT01563172|183401737|SUPERIORITY_OR_OTHER||LS mean difference|-822.88|||<|0.0001|TWO_SIDED|95.0|-1047.34|-598.42||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-598.42|-1047.34|<0.0001
91754322|NCT01563172|183401738|SUPERIORITY_OR_OTHER||LS mean difference|-574.79|||<|0.0001|TWO_SIDED|95.0|-808.08|-341.5||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-341.50|-808.08|<0.0001
91754323|NCT01563172|183401739|SUPERIORITY_OR_OTHER||LS mean difference|1294.34|||<|0.0001|TWO_SIDED|95.0|1069.24|1519.43||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||1519.43|1069.24|<0.0001
91754324|NCT01742065|183401746|SUPERIORITY|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.|Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.1|6.8||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||6.8|.1|.05
91754325|NCT01742065|183401747|OTHER|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.|Mean Difference (Final Values)|3.8||||0.02|TWO_SIDED|95.0|0.6|7.0||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||7|.6|.02
91508403|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2942|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2942
91508404|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.136||0.5389|TWO_SIDED|95.0|-0.35|0.19|||MMRM|||Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.35|0.5389
91754326|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||1|TWO_SIDED|95.0|0.083|0.359|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.359|0.083|1.000
91754327|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.23||||0.9999|TWO_SIDED|95.0|0.111|0.492|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.492|0.111|0.9999
91754328|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9997|TWO_SIDED|95.0|0.121|0.568|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.568|0.121|0.9997
91754329|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9997|TWO_SIDED|95.0|0.136|0.66|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.660|0.136|0.9997
91754330|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.133|0.632|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.632|0.133|0.9991
91754331|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.46||||0.9631|TWO_SIDED|95.0|0.213|1.081|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.081|0.213|0.9631
91754332|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9941||95.0|0.157|0.789|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.789|0.157|0.9941
91754333|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9875|TWO_SIDED|95.0|0.179|0.891|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.891|0.179|0.9875
91754334|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9956|TWO_SIDED|95.0|0.151|0.759|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.759|0.151|0.9956
91754335|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9964|TWO_SIDED|95.0|0.157|0.747|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.747|0.157|0.9964
91754336|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9999|TWO_SIDED|95.0|0.114|0.532|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.532|0.114|0.9999
91754337|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.647|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.647|0.130|0.9991
91754338|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.36||||0.9852|TWO_SIDED|0.9852|0.137|0.906|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.906|0.137|0.9852
91754339|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9719|TWO_SIDED|95.0|0.23|1.014|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.014|0.230|0.9719
91754340|NCT01597635|183401787|SUPERIORITY||Ratio of Active/Placebo|3.98||||1|TWO_SIDED|95.0|2.263|6.919|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||6.919|2.263|1.0000
91754341|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.46||||1|TWO_SIDED|95.0|1.976|6.052|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||6.052|1.976|1.000
91754342|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.59||||1|TWO_SIDED|95.0|2.06|6.345|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||6.345|2.060|1.0000
91754343|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.82||||0.9806|TWO_SIDED|95.0|1.031|3.17|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||3.170|1.031|0.9806
91754344|NCT01597635|183401787|SUPERIORITY||Ratio of Active/Placebo|1.5||||0.9129|TWO_SIDED|95.0|0.828|2.636|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||2.636|0.828|0.9129
91754345|NCT01597635|183401787|SUPERIORITY||Ratio of Active/Placebo|1.92||||0.9891|TWO_SIDED|95.0|1.098|3.349|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.349|1.098|0.9891
91754346|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.29||||0.9983|TWO_SIDED|95.0|1.316|3.974|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||3.974|1.316|0.9983
91754347|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.94||||0.99|TWO_SIDED|95.0|1.112|3.359|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||3.359|1.112|0.9900
91754348|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.7996|TWO_SIDED|95.0|0.729|2.163|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||2.163|0.729|0.7996
91754349|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7778|TWO_SIDED|95.0|0.718|2.087|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||2.087|0.718|0.7778
91754350|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.24||||0.773|TWO_SIDED|95.0|0.705|2.113|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.113|0.705|0.7730
91508405|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4061|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4061
91508406|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.153||0.099|TWO_SIDED|95.0|-0.56|0.05|||MMRM|||Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.56|0.0990
91532781|NCT01027871|182942374|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.17||||0.433|TWO_SIDED|90.0|-0.18|0.52||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.52|-0.18|0.433
91754351|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.45||||0.8951|TWO_SIDED|95.0|0.814|2.604|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.604|0.814|0.8951
91754352|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.57||||0.9324|TWO_SIDED|95.0|0.276|1.183|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||1.183|0.276|0.9324
91754353|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.63||||0.8982|TWO_SIDED|95.0|0.351|1.257|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.257|0.351|0.8982
91754354|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|4.22||||0.9998|TWO_SIDED|95.0|1.91|8.905|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||8.905|1.910|0.9998
91754355|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.67||||0.9993|TWO_SIDED|95.0|1.689|7.97|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||7.970|1.689|0.9993
91754356|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|5.26||||1|TWO_SIDED|95.0|2.392|11.754|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||11.754|2.392|1.0000
91508407|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.138||0.0108|TWO_SIDED|95.0|-0.63|-0.08|||MMRM|||Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.63|0.0108
91754357|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.25||||0.9713|TWO_SIDED|95.0|0.972|5.136|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||5.136|0.972|0.9713
91754358|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.19||||0.9649|TWO_SIDED|95.0|0.94|4.975|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||4.975|0.940|0.9649
91754359|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.59||||0.8749|TWO_SIDED|95.0|0.711|3.473|||Mixed Models Analysis|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.473|0.711|0.8749
91754360|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.99||||0.9566|TWO_SIDED|95.0|0.899|4.342|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||4.342|0.899|0.9566
91754361|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.91||||0.9549|TWO_SIDED|95.0|0.862|4.173|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||4.173|0.862|0.9549
91754362|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.81||||0.9275|TWO_SIDED|95.0|0.816|4.005|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||4.005|0.816|0.9275
91532782|NCT01027871|182942375|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.2||||0.388|TWO_SIDED|90.0|-0.59|0.19||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.59|0.388
91754363|NCT01597635|183401787|SUPERIORITY||Ratio of Active/Placebo|1.32||||0.7483|TWO_SIDED|95.0|0.584|3.007|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||3.007|0.584|0.7483
91754364|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.648|TWO_SIDED|95.0|0.516|2.675|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.675|0.516|0.6480
91754365|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.76||||0.9038|TWO_SIDED|95.0|0.741|4.17|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||4.170|0.741|0.9038
91754366|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7339|TWO_SIDED|95.0|0.49|3.915|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||3.915|0.490|0.7339
91754367|NCT01597635|183401787|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7714|TWO_SIDED|95.0|0.651|3.321|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.321|0.651|0.7714
91754368|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.07||||1|TWO_SIDED|95.0|0.032|0.14|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.032|1.0000
91508408|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0889|TWO_SIDED|95.0|-0.59|0.04|||MMRM|||Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.59|0.0889
91508409|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.3721|TWO_SIDED|95.0|-0.18|0.49|||MMRM|||Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.18|0.3721
91508410|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.141||0.5513|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5513
91508411|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0748|TWO_SIDED|95.0|-0.01|0.26|||MMRM|||Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.01|0.0748
91508412|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.087||0.3545|TWO_SIDED|95.0|-0.09|0.25|||MMRM|||Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.09|0.3545
91508413|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.094||0.6531|TWO_SIDED|95.0|-0.14|0.23|||MMRM|||Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.14|0.6531
91508414|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.115||0.752|TWO_SIDED|95.0|-0.26|0.19|||MMRM|||Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.26|0.7520
91532783|NCT01027871|182942376|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.09||||0.197|TWO_SIDED|90.0|-0.21|0.03||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.03|-0.21|0.197
91532784|NCT01027871|182942377|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%"|Fisher Exact|||||||0.609
91754369|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.048|0.209|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.209|0.048|1.0000
91754370|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.11||||1|TWO_SIDED|95.0|0.054|0.243|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.243|0.054|1.0000
91754371|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9996|TWO_SIDED|95.0|0.113|0.547|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.547|0.113|0.9996
91508415|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.123||0.8861|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.8861
91532785|NCT01027871|182942377|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.314
91532786|NCT01027871|182942378|SUPERIORITY_OR_OTHER|||||||0.375||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.375
91532787|NCT01027871|182942378|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||"The statistical significance level is 0.10.~P- value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.811
91754372|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.634|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.634|0.130|0.9991
91754373|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.32||||0.9979|TWO_SIDED|95.0|0.149|0.682|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.682|0.149|0.9979
91532788|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.43||||0.144|TWO_SIDED|90.0|-0.92|0.05||"The statistical significance level is 0.10.~P- value is for morning 2-hr postprandial BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.92|0.144
91508416|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.328|TWO_SIDED|95.0|-0.38|0.13|||MMRM|||Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.38|0.3280
91508417|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.128||0.1123|TWO_SIDED|95.0|-0.46|0.05|||MMRM|||Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.46|0.1123
91508418|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.116||0.2541|TWO_SIDED|95.0|-0.36|0.1|||MMRM|||Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.36|0.2541
91754374|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.19||||1||95.0|0.091|0.417|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.417|0.091|1.0000
91754375|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9998|TWO_SIDED|95.0|0.119|0.539|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.539|0.119|0.9998
91754376|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9985|TWO_SIDED|95.0|0.141|0.666|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.666|0.141|0.9985
91754377|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9977|TWO_SIDED|95.0|0.162|0.73|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.730|0.162|0.9977
91754378|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.22||||0.9999|TWO_SIDED|95.0|0.105|0.468|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.468|0.105|0.9999
91754379|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9996|TWO_SIDED|95.0|0.119|0.57|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.570|0.119|0.9996
91754380|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.82||||0.6621|TWO_SIDED|95.0|0.319|2.136|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||2.136|0.319|0.6621
91754381|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.79||||0.7085|TWO_SIDED|95.0|0.324|1.847|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.847|0.324|0.7085
91754382|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.06||||1|TWO_SIDED|95.0|0.028|0.14|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.028|1.0000
91532789|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.36|TWO_SIDED|90.0|-0.7|0.2||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.20|-0.70|0.360
91754383|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.043|0.216|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.216|0.043|1.0000
91754384|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.08||||1|TWO_SIDED|95.0|0.034|0.177|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.177|0.034|1.0000
91754385|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.2||||0.9998|TWO_SIDED|95.0|0.086|0.453|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.453|0.086|0.9998
91754386|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||0.9999|TWO_SIDED|95.0|0.075|0.4|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.400|0.075|0.9999
91754387|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.4||||0.9863|TWO_SIDED|95.0|0.173|0.901|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.901|0.173|0.9863
91532790|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.342|TWO_SIDED|90.0|-0.72|0.19||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.72|0.342
91532791|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.12||||0.654|TWO_SIDED|90.0|-0.56|0.32||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.56|0.654
91754388|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9998|TWO_SIDED|95.0|0.103|0.529|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.529|0.103|0.9998
91754389|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.28||||0.9992|TWO_SIDED|95.0|0.119|0.626|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.626|0.119|0.9992
91754390|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9995|TWO_SIDED|95.0|0.102|0.561|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.561|0.102|0.9995
91754391|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9964|TWO_SIDED|95.0|0.131|0.729|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.729|0.131|0.9964
91508419|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.143||0.011|TWO_SIDED|95.0|-0.66|-0.09|||MMRM|||Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.66|0.0110
91508420|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.772|TWO_SIDED|95.0|-0.36|0.27|||MMRM|||Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.36|0.7720
91508421|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6311|TWO_SIDED|95.0|-0.52|0.32|||MMRM|||Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.52|0.6311
91508422|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.207||0.6877|TWO_SIDED|95.0|-0.5|0.33|||MMRM|||Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.50|0.6877
91508423|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2465|TWO_SIDED|95.0|-0.15|0.58|||MMRM|||Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.15|0.2465
91532792|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.387|TWO_SIDED|90.0|-0.73|0.23||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.23|-0.73|0.387
91754392|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9995|TWO_SIDED|95.0|0.107|0.584|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.584|0.107|0.9995
91754393|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9993|TWO_SIDED|95.0|0.098|0.578|||Ratio of Active/Placebo|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.578|0.098|0.9993
91754394|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9781|TWO_SIDED|95.0|0.119|0.969|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.969|0.119|0.9781
91754395|NCT01597635|183401788|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9375|TWO_SIDED|95.0|0.154|1.341|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.341|0.154|0.9375
91754396|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2598|TWO_SIDED|95.0|0.752|1.215|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.215|0.752|0.2598
91754397|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3949|TWO_SIDED|95.0|0.783|1.273|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.273|0.783|0.3949
91754398|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4175|TWO_SIDED|95.0|0.791|1.294|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.294|0.791|0.4175
91754399|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.442|TWO_SIDED|95.0|0.806|1.292|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.292|0.806|0.4420
91754400|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4432|TWO_SIDED|95.0|0.811|1.262|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.262|0.811|0.4432
91754401|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4578|TWO_SIDED|95.0|0.818|1.229|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.229|0.818|0.4578
91754402|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3365|TWO_SIDED|95.0|0.79|1.167|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.167|0.790|0.3365
91754403|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.163|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.163|0.770|0.3339
91754404|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3608|TWO_SIDED|95.0|0.786|1.166|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.166|0.786|0.3608
91754405|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3584|TWO_SIDED|95.0|0.788|1.168|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.168|0.788|0.3584
91754406|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1219|TWO_SIDED|95.0|0.725|1.073|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.073|0.725|0.1219
91754407|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4662|TWO_SIDED|95.0|0.814|1.21|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.210|0.814|0.4662
91754408|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5748|TWO_SIDED|95.0|0.828|1.247|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.247|0.828|0.5748
91508424|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.101||0.1279|TWO_SIDED|95.0|-0.36|0.05|||MMRM|||Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.36|0.1279
91754409|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.4104|TWO_SIDED|95.0|0.786|1.204|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.204|0.786|0.4104
91754410|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5114|TWO_SIDED|95.0|0.817|1.246|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.246|0.817|0.5114
91754411|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4213|TWO_SIDED|95.0|0.783|1.2|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.200|0.783|0.4213
91754412|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2663|TWO_SIDED|95.0|0.731|1.132|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.132|0.731|0.2663
91754413|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2373|TWO_SIDED|95.0|0.72|1.142|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.142|0.720|0.2373
91754414|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2575|TWO_SIDED|95.0|0.721|1.149|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.149|0.721|0.2575
91754415|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2173|TWO_SIDED|95.0|0.708|1.127|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.127|0.708|0.2173
91754416|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2406|TWO_SIDED|95.0|0.717|1.143|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.143|0.717|0.2406
91754417|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2471|TWO_SIDED|95.0|0.721|1.151|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.151|0.721|0.2471
91754418|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2585|TWO_SIDED|95.0|0.727|1.157|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.157|0.727|0.2585
91754419|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.3101|TWO_SIDED|95.0|0.737|1.17|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.170|0.737|0.3101
91754420|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2476|TWO_SIDED|95.0|0.727|1.16|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.160|0.727|0.2476
91754421|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3887|TWO_SIDED|95.0|0.767|1.222|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.222|0.767|0.3887
91754422|NCT01597635|183401789|SUPERIORITY||Ratio of Active/Placebo|0.92||||0.2294|TWO_SIDED|95.0|0.749|1.146|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.146|0.749|0.2294
91754423|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8522|TWO_SIDED|95.0|0.916|1.234|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.234|0.916|0.8522
91754424|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5885|TWO_SIDED|95.0|0.89|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.164|0.890|0.5885
91754425|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8558|TWO_SIDED|95.0|0.94|1.23|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.230|0.940|0.8558
91754426|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8374|TWO_SIDED|95.0|0.932|1.224|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hour||1.224|0.932|0.8374
91754427|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5886|TWO_SIDED|95.0|0.887|1.152|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.152|0.887|0.5886
91754428|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.7532|TWO_SIDED|95.0|0.918|1.18|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.180|0.918|0.7532
91754429|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7108|TWO_SIDED|95.0|0.906|1.179|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.179|0.906|0.7108
91754430|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7445|TWO_SIDED|95.0|0.918|1.19|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.190|0.918|0.7445
91754431|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3759|TWO_SIDED|95.0|0.863|1.115|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.115|0.863|0.3759
91754432|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.398|TWO_SIDED|95.0|0.859|1.118|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.118|0.859|0.3980
91754433|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3231|TWO_SIDED|95.0|0.849|1.103|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.103|0.849|0.3231
91754434|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.1245|TWO_SIDED|95.0|0.812|1.056|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.056|0.812|0.1245
91754435|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4631|TWO_SIDED|95.0|0.87|1.134|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.134|0.870|0.4631
91754436|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.1026|TWO_SIDED|95.0|0.801|1.047|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.047|0.801|0.1026
91754437|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3152|TWO_SIDED|95.0|0.85|1.101|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.101|0.850|0.3152
91754438|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.0762|TWO_SIDED|95.0|0.803|1.035|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.035|0.803|0.0762
91754439|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.0274||95.0|0.763|1.003|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.003|0.763|0.0274
91754440|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3594|TWO_SIDED|95.0|0.853|1.112|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.112|0.853|0.3594
91754441|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7027|TWO_SIDED|95.0|0.906|1.197|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.197|0.906|0.7027
91754442|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8661|TWO_SIDED|95.0|0.941|1.246|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.246|0.941|0.8661
91754443|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.8084|TWO_SIDED|95.0|0.924|1.228|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.228|0.924|0.8084
91754444|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.9504|TWO_SIDED|95.0|0.976|1.3|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.300|0.976|0.9504
91754445|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.53|TWO_SIDED|95.0|0.871|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.164|0.871|0.5300
91754446|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8595|TWO_SIDED|95.0|0.942|1.243|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.243|0.942|0.8595
91754447|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8802|TWO_SIDED|95.0|0.943|1.261|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.261|0.943|0.8802
91754448|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.11||||0.9232|TWO_SIDED|95.0|0.958|1.278|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.278|0.958|0.9232
91754449|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.7911|TWO_SIDED|95.0|0.902|1.256|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.256|0.902|0.7911
91754450|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.28||||0.9946|TWO_SIDED|95.0|1.059|1.514|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.514|1.059|0.9946
91754451|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.983|TWO_SIDED|95.0|1.019|1.444|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.444|1.019|0.9830
91754452|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8024|TWO_SIDED|95.0|0.91|1.261|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.261|0.910|0.8024
91754453|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4806|TWO_SIDED|95.0|0.843|1.166|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.166|0.843|0.4806
91754454|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6658|TWO_SIDED|95.0|0.869|1.223|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.223|0.869|0.6658
91754455|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.6131|TWO_SIDED|95.0|0.856|1.212|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.212|0.856|0.6131
91754456|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5795|TWO_SIDED|95.0|0.856|1.197|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.197|0.856|0.5795
91754457|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0209|TWO_SIDED|95.0|0.716|0.993|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||0.993|0.716|0.0209
91754458|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4823|TWO_SIDED|95.0|0.83|1.187|||Mixed Models Analysis|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.187|0.830|0.4823
91754459|NCT01597635|183401789|SUPERIORITY_OR_OTHER||0.0406|0.85||||0.0406|TWO_SIDED|95.0|0.703|1.021|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.021|0.703|0.0406
91754460|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5186|TWO_SIDED|95.0|0.844|1.169|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.169|0.844|0.5186
91754461|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.387|TWO_SIDED|95.0|0.824|1.132|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.132|0.824|0.3870
91754462|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.1281|TWO_SIDED|95.0|0.77|1.065|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.065|0.770|0.1281
91754463|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4754|TWO_SIDED|95.0|0.837|1.181|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.181|0.837|0.4754
91508425|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.093||0.3946|TWO_SIDED|95.0|-0.26|0.1|||MMRM|||Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.26|0.3946
91508426|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.095||0.6694|TWO_SIDED|95.0|-0.23|0.15|||MMRM|||Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.23|0.6694
91508427|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1113|TWO_SIDED|95.0|-0.36|0.04|||MMRM|||Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.36|0.1113
91508428|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.5811|TWO_SIDED|95.0|-0.13|0.23|||MMRM|||Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.13|0.5811
91508429|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.106||0.6794|TWO_SIDED|95.0|-0.25|0.17|||MMRM|||Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.25|0.6794
91508430|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.099||0.6031|TWO_SIDED|95.0|-0.14|0.25|||MMRM|||Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.14|0.6031
91508431|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.099||0.6673|TWO_SIDED|95.0|-0.24|0.15|||MMRM|||Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.24|0.6673
91508432|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.102||0.6472|TWO_SIDED|95.0|-0.25|0.16|||MMRM|||Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.25|0.6472
91508433|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.119||0.8654|TWO_SIDED|95.0|-0.26|0.22|||MMRM|||Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.26|0.8654
91508434|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2101|TWO_SIDED|95.0|-0.48|0.11|||MMRM|||Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.48|0.2101
91508435|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.126||0.7128|TWO_SIDED|95.0|-0.3|0.21|||MMRM|||Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.30|0.7128
91508436|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3297|TWO_SIDED|95.0|-0.27|0.09|||MMRM|||Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.27|0.3297
91532793|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.339|TWO_SIDED|90.0|-0.79|0.21||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.21|-0.79|0.339
91754464|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5627|TWO_SIDED|95.0|0.856|1.217|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.217|0.856|0.5627
91754465|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5552|TWO_SIDED|95.0|0.848|1.22|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.220|0.848|0.5552
91754466|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.503|TWO_SIDED|95.0|0.843|1.201|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.201|0.843|0.5030
91754467|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5558|TWO_SIDED|95.0|0.84|1.218|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.218|0.840|0.5558
91754468|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.2709|TWO_SIDED|95.0|0.769|1.135|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.135|0.769|0.2709
91754469|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4143|TWO_SIDED|95.0|0.795|1.208|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.208|0.795|0.4143
91754470|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.7886|TWO_SIDED|95.0|0.891|1.348|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.348|0.891|0.7886
91754471|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.7607|TWO_SIDED|95.0|0.885|1.353|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.353|0.885|0.7607
91508437|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.069||0.4493|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.08|0.4493
91508438|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.081||0.0717|TWO_SIDED|95.0|-0.01|0.31|||MMRM|||Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.01|0.0717
91508439|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.066||0.1054|TWO_SIDED|95.0|-0.02|0.24|||MMRM|||Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.02|0.1054
91508440|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.088||0.0408|TWO_SIDED|95.0|0.01|0.36|||MMRM|||Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|0.01|0.0408
91508441|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.088||0.0233|TWO_SIDED|95.0|0.03|0.38|||MMRM|||Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|0.03|0.0233
91508442|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.088||0.361|TWO_SIDED|95.0|-0.09|0.26|||MMRM|||Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.09|0.3610
91508443|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2358|TWO_SIDED|95.0|-0.08|0.32|||MMRM|||Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.08|0.2358
91508444|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.085||0.9492|TWO_SIDED|95.0|-0.16|0.17|||MMRM|||Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.16|0.9492
91508445|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.102||0.4352|TWO_SIDED|95.0|-0.28|0.12|||MMRM|||Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.28|0.4352
91754472|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.8677|TWO_SIDED|95.0|0.922|1.4|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.400|0.922|0.8677
91754473|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.7012|TWO_SIDED|95.0|0.847|1.302|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.302|0.847|0.7012
91754474|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5156|TWO_SIDED|95.0|0.805|1.23|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.230|0.805|0.5156
91754475|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3524|TWO_SIDED|95.0|0.783|1.178|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.178|0.783|0.3524
91754476|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.638|TWO_SIDED|95.0|0.845|1.292|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.292|0.845|0.6380
91754477|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.4003|TWO_SIDED|95.0|0.743|1.241|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.241|0.743|0.4003
91532794|NCT01027871|182942379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.1||||0.676|TWO_SIDED|90.0|-0.3|0.5||"The statistical significance level is 0.10.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.50|-0.30|0.676
91754478|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.16||||0.8817|TWO_SIDED|95.0|0.907|1.502|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.502|0.907|0.8817
91754479|NCT01597635|183401789|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.14||||0.8145|TWO_SIDED|95.0|0.804|1.505|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.505|0.804|0.8145
91754480|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6468|TWO_SIDED|95.0|0.765|1.321|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.321|0.765|0.6468
91754481|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1965|TWO_SIDED|95.0|0.658|1.136|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.136|0.658|0.1965
91754482|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1681|TWO_SIDED|95.0|0.694|1.129|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.129|0.694|0.1681
91754483|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0877|TWO_SIDED|95.0|0.669|1.075|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.075|0.669|0.0877
91754484|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2011|TWO_SIDED|95.0|0.715|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.159|0.715|0.2011
91754485|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6855|TWO_SIDED|95.0|0.842|1.345|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.345|0.842|0.6855
91754486|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6093|TWO_SIDED|95.0|0.8|1.325|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.325|0.800|0.6093
91754487|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.435|TWO_SIDED|95.0|0.765|1.253|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.253|0.765|0.4350
91754488|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2232|TWO_SIDED|95.0|0.722|1.195|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.195|0.722|0.2232
91754489|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2716|TWO_SIDED|95.0|0.733|1.2|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.200|0.733|0.2716
91754490|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2866|TWO_SIDED|95.0|0.726|1.19|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.190|0.726|0.2866
91754491|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5033|TWO_SIDED|95.0|0.78|1.27|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.270|0.780|0.5033
91754492|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1493|TWO_SIDED|95.0|0.684|1.12|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.120|0.684|0.1493
91754493|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4947|TWO_SIDED|95.0|0.759|1.301|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.301|0.759|0.4947
91754494|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.89||||0.1951|TWO_SIDED|95.0|0.678|1.161|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.161|0.678|0.1951
91754495|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.8||||0.0512|TWO_SIDED|95.0|0.612|1.05|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.050|0.612|0.0512
91754496|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.47|TWO_SIDED|95.0|0.775|1.279|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.279|0.775|0.4700
91754497|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.634|TWO_SIDED|95.0|0.811|1.368|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.368|0.811|0.6340
91754498|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2129|TWO_SIDED|95.0|0.689|1.183|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.183|0.689|0.2129
91754499|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6418|TWO_SIDED|95.0|0.798|1.411|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.411|0.798|0.6418
91754500|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4797|TWO_SIDED|95.0|0.754|1.315|||Ratio of Active/Placebo|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.315|0.754|0.4797
91532795|NCT01027871|182942381|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||The statistical significance level is 0.10.|Fisher Exact|||||||0.162
91532796|NCT01027871|182942382|SUPERIORITY_OR_OTHER|||||||0.804||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.804
91508446|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.125||0.1176|TWO_SIDED|95.0|-0.05|0.44|||MMRM|||Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.05|0.1176
91508447|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.174||0.7812|TWO_SIDED|95.0|-0.3|0.4|||MMRM|||Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.30|0.7812
91508448|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.182||0.5085|TWO_SIDED|95.0|-0.48|0.24|||MMRM|||Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.48|0.5085
91508449|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.156||0.8274|TWO_SIDED|95.0|-0.28|0.34|||MMRM|||Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.28|0.8274
91508450|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3675|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3675
91508451|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1818|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1818
91508452|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0826|TWO_SIDED|95.0|-0.17|0.01|||MMRM|||Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.17|0.0826
91532797|NCT01027871|182942384|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.937||90.0|-0.16|0.14||"The statistical significance level is 0.10.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.14|-0.16|0.937
91532798|NCT01027871|182942384|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.03||||0.687|TWO_SIDED|90.0|-0.16|0.1||"The statistical significance level is 0.10.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.10|-0.16|0.687
91532799|NCT01027871|182942386|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.159|TWO_SIDED|90.0|-0.87|0.07||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-0.87|0.159
91508453|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6436|TWO_SIDED|95.0|-0.11|0.07|||MMRM|||Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.11|0.6436
91508454|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1827|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1827
91508455|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.045||0.9859|TWO_SIDED|95.0|-0.09|0.09|||MMRM|||Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.09|0.9859
91508456|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6672|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6672
91508457|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.046||0.2031|TWO_SIDED|95.0|-0.03|0.15|||MMRM|||Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.03|0.2031
91508458|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6664|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6664
91508459|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3417|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3417
91508460|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.6622|TWO_SIDED|95.0|-0.12|0.08|||MMRM|||Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.12|0.6622
91508461|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.9087|TWO_SIDED|95.0|-0.11|0.09|||MMRM|||Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.11|0.9087
91532800|NCT01027871|182942386|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.542|TWO_SIDED|90.0|-0.62|0.29||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.29|-0.62|0.542
91532801|NCT01027871|182942387|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.88|TWO_SIDED|90.0|-0.16|0.13||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.16|0.880
91532802|NCT01027871|182942387|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.045|TWO_SIDED|90.0|-0.32|-0.03||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.03|-0.32|0.045
91532803|NCT01027871|182942388|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.273
91532804|NCT01027871|182942388|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.287
91532805|NCT01027871|182942388|SUPERIORITY_OR_OTHER|||||||0.879||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.879
91508462|NCT02942017|182888947|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.8263|TWO_SIDED|95.0|-0.08|0.1|||MMRM|||Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.08|0.8263
91508463|NCT02942017|182888948|SUPERIORITY||LS mean difference|-4.86|STANDARD_ERROR_OF_MEAN|1.612||0.0033|TWO_SIDED|95.0|-8.06|-1.66|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.66|-8.06|0.0033
91508464|NCT02942017|182888948|SUPERIORITY||LS mean difference|-3.56|STANDARD_ERROR_OF_MEAN|2.154||0.1017|TWO_SIDED|95.0|-7.84|0.72|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.72|-7.84|0.1017
91508465|NCT02942017|182888948|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|1.884||0.9845|TWO_SIDED|95.0|-3.72|3.79|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.79|-3.72|0.9845
91508466|NCT02942017|182888949|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0005|TWO_SIDED|95.0|2.0|12.5|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||12.5|2.0|0.0005
91508467|NCT02942017|182888949|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0478|TWO_SIDED|95.0|1.0|8.4|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||8.4|1.0|0.0478
91508468|NCT02942017|182888949|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4399|TWO_SIDED|95.0|0.5|4.6|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||4.6|0.5|0.4399
91508469|NCT02942017|182888950|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.041||0.2636|TWO_SIDED|95.0|-3.24|0.9|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.90|-3.24|0.2636
91508470|NCT02942017|182888950|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|1.103||0.4897|TWO_SIDED|95.0|-2.96|1.43|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.43|-2.96|0.4897
91532806|NCT01027871|182942388|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.722
91532807|NCT01027871|182942389|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.139
91754501|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2659|TWO_SIDED|95.0|0.703|1.199|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.199|0.703|0.2659
91754502|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2102|TWO_SIDED|95.0|0.687|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.159|0.687|0.2102
91754503|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3623|TWO_SIDED|95.0|0.74|1.24|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.240|0.740|0.3623
91754504|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3499|TWO_SIDED|95.0|0.73|1.225|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.225|0.730|0.3499
91754505|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6494|TWO_SIDED|95.0|0.787|1.377|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.377|0.787|0.6494
91754506|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5567|TWO_SIDED|95.0|0.766|1.358|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.358|0.766|0.5567
91754507|NCT01597635|183401790|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.1095|TWO_SIDED|95.0|0.615|1.073|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.073|0.615|0.1095
91754508|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6098|TWO_SIDED|95.0|0.721|1.644|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.644|0.721|0.6098
91754509|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.35||||0.9441|TWO_SIDED|95.0|0.931|2.068|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||2.068|0.931|0.9441
91754510|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.7173|TWO_SIDED|95.0|0.749|1.621|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.621|0.749|0.7173
91754511|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.8292|TWO_SIDED|95.0|0.81|1.949|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.949|0.810|0.8292
91754512|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.8008|TWO_SIDED|95.0|0.775|1.832|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.832|0.775|0.8008
91754513|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.2||||0.7905|TWO_SIDED|95.0|0.776|1.799|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.799|0.776|0.7905
91754514|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7566|TWO_SIDED|95.0|0.737|1.958|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.958|0.737|0.7566
91754515|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.8349|TWO_SIDED|95.0|0.812|2.05|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||2.050|0.812|0.8349
91754516|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4739|TWO_SIDED|95.0|0.713|1.527|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.527|0.713|0.4739
91754517|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6291|TWO_SIDED|95.0|0.763|1.647|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.647|0.763|0.6291
91754518|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.18||||0.8032|TWO_SIDED|95.0|0.83|1.814|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.814|0.830|0.8032
91508471|NCT02942017|182888950|SUPERIORITY||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|1.227||0.1341|TWO_SIDED|95.0|-4.3|0.59|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-4.30|0.1341
91508472|NCT02942017|182888950|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.408||0.1691|TWO_SIDED|95.0|-4.76|0.85|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.85|-4.76|0.1691
91508473|NCT02942017|182888950|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|1.149||0.7852|TWO_SIDED|95.0|-2.6|1.97|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-2.60|0.7852
91508474|NCT00739752|182889017|SUPERIORITY||Risk Ratio (RR)|0.99|||=|0.885|TWO_SIDED|95.0|0.88|1.12|||Regression, Poisson|||The two gain-framed groups were compared to the two loss-framed groups using poisson regression.||1.12|.88|=.885
91532808|NCT01027871|182942389|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.569
91508475|NCT00739752|182889017|SUPERIORITY||Risk Ratio (RR)|1.17|||<|0.01|TWO_SIDED|95.0|1.06|1.31|||Regression, Poisson|||Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.||1.31|1.06|<.01
91532809|NCT01027871|182942389|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.515
91508476|NCT00739752|182889017|SUPERIORITY||Risk Ratio (RR)|1.16|||<|0.01|TWO_SIDED|95.0|1.05|1.28|||Regression, Poisson|||The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.||1.28|1.05|<.01
91508477|NCT00249470|182889028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8||||0.004|TWO_SIDED|95.0|2.03|16.56|||General Estimating Equation (GEE)|||||16.56|2.03|.004
91508478|NCT00249470|182889029|SUPERIORITY||Odds Ratio (OR)|0.91|||=|0.82|TWO_SIDED|95.0|0.4|2.08|||General Estimating Equation (GEE)|||||2.08|0.40|=0.82
91508479|NCT00249470|182889030|SUPERIORITY||Odds Ratio (OR)|3.37||||0.04|TWO_SIDED|95.0|1.21|9.37|||General Estimating Equation (GEE)|||||9.37|1.21|0.04
91508480|NCT00245765|182889031|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.001|TWO_SIDED|95.0|13.7|150.3|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||150.3|13.7|<0.001
91508481|NCT00245765|182889031|SUPERIORITY||Odds Ratio (OR)|73.4|||<|0.001|TWO_SIDED|95.0|23.5|292.6|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||292.6|23.5|<0.001
91508482|NCT00245765|182889032|SUPERIORITY||Odds Ratio (OR)|64.1|||<|0.001|TWO_SIDED|95.0|12.7|1169.1|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.||||1169.1|12.7|<0.001
91508483|NCT00245765|182889032|SUPERIORITY||Odds Ratio (OR)|162.6|||<|0.001|TWO_SIDED|95.0|31.4|2999.2|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||2999.2|31.4|<0.001
91532810|NCT01027871|182942389|SUPERIORITY_OR_OTHER|||||||1||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||1.000
91532811|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.26||||0.305|TWO_SIDED|90.0|-0.16|0.67||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.67|-0.16|0.305
91532812|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.14||||0.571|TWO_SIDED|90.0|-0.54|0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.26|-0.54|0.571
91754519|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.325|TWO_SIDED|95.0|0.626|1.416|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.416|0.626|0.3250
91754520|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5828|TWO_SIDED|95.0|0.687|1.63|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.630|0.687|0.5828
91508484|NCT06425458|182889046|OTHER|||||||0.0011||||||Threshold for statistical significance: P \<= 0.05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Esteem (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0011
91508485|NCT06425458|182889046|OTHER|||||||0.0719||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Purpose in Life (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0719
91508486|NCT06425458|182889046|OTHER|||||||0.7991||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Locus of Control (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.7991
91508487|NCT06425458|182889046|OTHER|||||||0.2208||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Efficacy (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.2208
91508488|NCT06425458|182889046|OTHER||Spearman partial correlation coefficient|0.37|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Esteem). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
91508489|NCT06425458|182889046|OTHER||Spearman partial correlation coefficient|-0.29|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Purpose in Life). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
91532813|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.454||90.0|-0.85|0.32||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.85|0.454
91532814|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.83||||0.016|TWO_SIDED|90.0|-1.4|-0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.26|-1.40|0.016
91754521|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4546|TWO_SIDED|95.0|0.661|1.512|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.512|0.661|0.4546
91508490|NCT06425458|182889046|OTHER||Spearman partial correlation coefficient|-0.58|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Locus of Control). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
91508491|NCT06425458|182889046|OTHER||Spearman partial correlation coefficient|-0.14|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Efficacy). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
91508492|NCT02917031|182889079|SUPERIORITY||Mean Difference (Final Values)|-2.595||||0.252|TWO_SIDED|95.0|-7.04|1.85|||ANCOVA|||Change from baseline, saxagliptin versus placebo.||1.850|-7.040|0.252
91508493|NCT02917031|182889080|SUPERIORITY||Mean Difference (Final Values)|-1.631||||0.425|TWO_SIDED|95.0|-5.635|2.373|||ANCOVA|||Saxagliptin: Change from baseline||2.373|-5.635|0.425
91754522|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6158|TWO_SIDED|95.0|0.719|1.639|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.639|0.719|0.6158
91754523|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7748|TWO_SIDED|95.0|0.752|1.77|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.770|0.752|0.7748
91754524|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.6565|TWO_SIDED|95.0|0.686|1.714|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.714|0.686|0.6565
91754525|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.87||||0.2773|TWO_SIDED|95.0|0.566|1.38|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.380|0.566|0.2773
91754526|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.3606|TWO_SIDED|95.0|0.61|1.467|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.467|0.610|0.3606
91754527|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.2211|TWO_SIDED|95.0|0.555|1.317|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.317|0.555|0.2211
91754528|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.286|TWO_SIDED|95.0|0.587|1.348|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.348|0.587|0.2860
91508494|NCT02917031|182889081|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.925|TWO_SIDED|95.0|-1.996|2.197|||ANCOVA|||"Saxagliptin vs Placebo:~Change from baseline"||2.197|-1.996|0.925
91508495|NCT02917031|182889082|SUPERIORITY||Mean Difference (Final Values)|-3.605||||0.105|TWO_SIDED|95.0|-7.97|0.76|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||0.760|-7.970|0.105
91754529|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.4079|TWO_SIDED|95.0|0.609|1.51|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.510|0.609|0.4079
91754530|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5284|TWO_SIDED|95.0|0.614|1.663|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.663|0.614|0.5284
91754531|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.3586|TWO_SIDED|95.0|0.568|1.458|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.458|0.568|0.3586
91754532|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.6768|TWO_SIDED|95.0|0.672|1.853|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.853|0.672|0.6768
91754533|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.77||||0.1574|TWO_SIDED|95.0|0.488|1.39|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.390|0.488|0.1574
91508496|NCT02917031|182889083|SUPERIORITY||Ratio for relative change|0.971||||0.796|TWO_SIDED|95.0|0.777|1.214|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||1.214|0.777|0.796
91508497|NCT02449356|182889085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91508498|NCT02449356|182889086|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91508499|NCT00640510|182889107|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||A sample size of at least 15 patients per group was necessary to verify that the decrease in PANSS-EC total score was significantly greater in the IM olanzapine group than the placebo group using Student's t-test with a power of 90% at a two-sided significance level of 5%.||||0.940
91754534|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.39|TWO_SIDED|95.0|0.521|1.584|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.584|0.521|0.3900
91754535|NCT01597635|183401791|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5915|TWO_SIDED|95.0|0.748|1.516|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.516|0.748|0.5915
91508500|NCT00640510|182889108|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Change from Baseline to 15 minutes. Change = Timepoint minus Baseline.|t-test, 2 sided|||||||1.000
91508501|NCT00640510|182889108|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value for Change from Baseline to 30 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.620
91508502|NCT00640510|182889108|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Change from Baseline to 60 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.784
91508503|NCT00640510|182889108|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Change from Baseline to 90 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.756
91508504|NCT00640510|182889109|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
91508505|NCT00640510|182889110|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 30 Minutes.|Fisher Exact|||||||1.000
91754536|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.06828|TWO_SIDED|95.0|0.528|1.501|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.501|0.528|0.06828
91754537|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.5674|TWO_SIDED|95.0|0.57|1.609|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.609|0.570|0.5674
91754538|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.66||||0.8855|TWO_SIDED|95.0|0.321|1.316|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.316|0.321|0.8855
91754539|NCT01597635|183401794|SUPERIORITY||Ratio of Active/Placebo|0.97||||0.5358|TWO_SIDED|95.0|0.531|1.76|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.760|0.531|0.5358
91754540|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.699|TWO_SIDED|95.0|0.622|2.155|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.155|0.622|0.6990
91754541|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.513|TWO_SIDED|95.0|0.549|1.721|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.721|0.549|0.5130
91508506|NCT00640510|182889110|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 60 Minutes.|Fisher Exact|||||||1.000
91508507|NCT00640510|182889110|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 90 Minutes.|Fisher Exact|||||||1.000
91754542|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.73||||0.7696|TWO_SIDED|95.0|0.3|1.731|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.731|0.300|0.7696
91508508|NCT00640510|182889110|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 2 Hours.|Fisher Exact|||||||1.000
91508509|NCT04300296|182889128|OTHER||Posterior median difference|-13.9|||||TWO_SIDED|95.0|-44.8|19.3|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||19.3|-44.8|
91508510|NCT04300296|182889128|OTHER||Posterior median difference|14.1|||||TWO_SIDED|95.0|-17.0|40.7|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||40.7|-17.0|
91508511|NCT04300296|182889128|OTHER||Posterior median difference|6.5|||||TWO_SIDED|95.0|-25.4|35.4|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||35.4|-25.4|
91508512|NCT02624284|182889161|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on latency to smoke. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.94|||||||Regression, Linear|||||||0.94
91508513|NCT02624284|182889162|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on number of cigarettes smoked. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.53|||||||Regression, Linear|||||||0.53
91754543|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9254|TWO_SIDED|95.0|0.203|1.289|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.289|0.203|0.9254
91754544|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.72||||0.7088|TWO_SIDED|95.0|0.216|2.419|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.419|0.216|0.7088
91754545|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.47||||0.8787|TWO_SIDED|95.0|0.112|1.69|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.690|0.112|0.8787
91754546|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7338|TWO_SIDED|95.0|0.714|1.197|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.197|0.714|0.7338
91754547|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4955|TWO_SIDED|95.0|0.703|1.415|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.415|0.703|0.4955
91754548|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5264|TWO_SIDED|95.0|0.541|1.788|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.788|0.541|0.5264
91754549|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.6183|TWO_SIDED|95.0|0.454|1.742|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.742|0.454|0.6183
91754550|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.5291|TWO_SIDED|95.0|0.483|2.118|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.118|0.483|0.5291
91754551|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.74|TWO_SIDED|95.0|0.828|1.448|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.448|0.828|0.7400
91754552|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.9375|TWO_SIDED|95.0|0.937|1.683|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.683|0.937|0.9375
91754553|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9118|TWO_SIDED|95.0|0.896|1.771|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.771|0.896|0.9118
91754554|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.43||||0.9217|TWO_SIDED|95.0|0.866|2.382|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.382|0.866|0.9217
91754555|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.48||||0.8676|TWO_SIDED|95.0|0.73|3.064|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.064|0.730|0.8676
91754556|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.8835|TWO_SIDED|95.0|0.609|1.135|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.135|0.609|0.8835
91508514|NCT02624284|182889164|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on days of abstinence. Age, sex, race and nicotine dependence were included as covariates.||||||0.78|||||||Regression, Linear|||||||0.78
91508515|NCT02506816|182889169|OTHER|The P-valor Wilcoxon method is a non-parametric statistical hypothesis test used to evaluate changes from baseline H-score values of the three biomarkers.||||||0.033||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of 3 biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.033
91508516|NCT02506816|182889170|OTHER|The differences in the change from baseline of different biomarkers were evaluated by the P-valor Wilcoxon method, a non-parametric statistical hypothesis test.||||||0.03||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of several biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.03
91508517|NCT02477020|182889184|SUPERIORITY_OR_OTHER||Least square mean difference|-5.46|STANDARD_ERROR_OF_MEAN|3.442||0.115|TWO_SIDED|95.0|-12.26|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM|MMRM||TAK-063 - Placebo. Baseline Positive and Negative Symptom Scale (PANSS) total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|||1.35|-12.26|0.115
91532815|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.07||||0.838||90.0|-0.61|0.48||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.48|-0.61|0.838
91532816|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.69||||0.033|TWO_SIDED|90.0|-1.22|-0.16||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.16|-1.22|0.033
91754557|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5446|TWO_SIDED|95.0|0.723|1.33|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.330|0.723|0.5446
91754558|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.6267|TWO_SIDED|95.0|0.679|1.333|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.333|0.679|0.6267
91754559|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.7668|TWO_SIDED|95.0|0.612|1.26|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.260|0.612|0.7668
91754560|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.61|TWO_SIDED|95.0|0.588|1.509|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.509|0.588|0.6100
91754561|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.68||||0.8159|TWO_SIDED|95.0|0.291|1.623|||Bayesian repeated measures model|||Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.623|0.291|0.8159
91754562|NCT01597635|183401794|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.53||||0.7988|TWO_SIDED|95.0|0.106|2.657|||Bayesian repeated measures model|||Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.657|0.106|0.7988
91754563|NCT01597635|183401795|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6536|TWO_SIDED|95.0|0.626|2.024|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||2.024|0.626|0.6536
91754564|NCT01597635|183401795|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.3||||0.9066|TWO_SIDED|95.0|0.876|1.955|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.955|0.876|0.9066
91754565|NCT01597635|183401795|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7859|TWO_SIDED|95.0|0.723|2.066|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.066|0.723|0.7859
91754566|NCT01597635|183401795|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.6058|TWO_SIDED|95.0|0.413|1.963|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.963|0.413|0.6058
91754567|NCT01597635|183401795|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.29||||0.6921|TWO_SIDED|95.0|0.456|3.632|||Ratio of Active/Placebo|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||3.632|0.456|0.6921
91754568|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7934|TWO_SIDED|95.0|0.737|1.14|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.140|0.737|0.7934
91754569|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5205|TWO_SIDED|95.0|0.782|1.317|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.317|0.782|0.5205
91754570|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6682|TWO_SIDED|95.0|0.673|1.865|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.865|0.673|0.6682
91754571|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.5304|TWO_SIDED|95.0|0.744|1.315|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.315|0.744|0.5304
91754572|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.81||||0.9078|TWO_SIDED|95.0|0.582|1.112|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.112|0.582|0.9078
91754573|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9907|TWO_SIDED|95.0|1.042|1.526|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.526|1.042|0.9907
91754574|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.9973|TWO_SIDED|95.0|1.005|1.606|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.606|1.005|0.9973
91508518|NCT02477020|182889185|SUPERIORITY_OR_OTHER||Least square mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.508||0.602|TWO_SIDED|95.0|-3.77|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 1||2.19|-3.77|0.602
91508519|NCT02477020|182889185|SUPERIORITY_OR_OTHER||Least square mean difference|-2.22|STANDARD_ERROR_OF_MEAN|2.229||0.322|TWO_SIDED|95.0|-6.62|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 2||2.19|-6.62|0.322
91508520|NCT02477020|182889185|SUPERIORITY_OR_OTHER||Least square mean difference|-3.46|STANDARD_ERROR_OF_MEAN|2.813||0.221|TWO_SIDED|95.0|-9.02|2.1||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 3||2.10|-9.02|0.221
91508521|NCT02477020|182889185|SUPERIORITY_OR_OTHER||Least square mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.147||0.504|TWO_SIDED|95.0|-8.33|4.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 4||4.11|-8.33|0.504
91532817|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.229|TWO_SIDED|90.0|-0.95|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.95|0.229
91532818|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.27||||0.412|TWO_SIDED|90.0|-0.8|0.27||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.27|-0.80|0.412
91754575|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.61||||0.9954|TWO_SIDED|95.0|1.13|2.331|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.331|1.130|0.9954
91508522|NCT02477020|182889185|SUPERIORITY_OR_OTHER||Least square mean difference|-3.91|STANDARD_ERROR_OF_MEAN|3.231||0.229|TWO_SIDED|95.0|-10.3|2.48||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 5||2.48|-10.30|0.229
91508523|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.562||0.195|TWO_SIDED|95.0|-1.84|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 1||0.38|-1.84|0.195
91532819|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.15||||0.642|TWO_SIDED|90.0|-0.68|0.38||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.38|-0.68|0.642
91754576|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.65||||0.983|TWO_SIDED|95.0|1.045|2.588|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.588|1.045|0.9830
91754577|NCT01597635|183401796|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.52||||0.9312|TWO_SIDED|95.0|0.867|2.737|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.737|0.867|0.9312
91754578|NCT04557787|183401846|SUPERIORITY||Mean Difference (Final Values)|28.4||||0.001|TWO_SIDED|95.0|12.2|44.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.6|12.2|0.001
91532820|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.16||||0.614|TWO_SIDED|90.0|-0.67|0.36||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.36|-0.67|0.614
91754579|NCT04557787|183401846|SUPERIORITY||Mean Difference (Final Values)|28.2||||0.001|TWO_SIDED|95.0|12.0|44.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.4|12.0|0.001
91754580|NCT04557787|183401846|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.983|TWO_SIDED|95.0|-16.0|16.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||16.3|-16.0|0.983
91754581|NCT04557787|183401847|SUPERIORITY||Mean Difference (Final Values)|33.2|||<|0.001|TWO_SIDED|95.0|17.0|49.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.4|17.0|<0.001
91508524|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.786||0.132|TWO_SIDED|95.0|-2.74|0.36||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 2||0.36|-2.74|0.132
91508525|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.959||0.045|TWO_SIDED|95.0|-3.84|-0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 3||-0.05|-3.84|0.045
91754582|NCT04557787|183401847|SUPERIORITY||Mean Difference (Final Values)|29.7|||<|0.001|TWO_SIDED|95.0|13.5|46.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||46.0|13.5|<0.001
91754583|NCT04557787|183401847|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.667|TWO_SIDED|95.0|-12.6|19.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.7|-12.6|0.667
91754584|NCT04557787|183401848|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.503|TWO_SIDED|95.0|-14.2|7.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||7.0|-14.2|0.503
91754585|NCT04557787|183401848|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.916|TWO_SIDED|95.0|-10.1|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-10.1|0.916
91754586|NCT04557787|183401848|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.438|TWO_SIDED|95.0|-14.8|6.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied||6.5|-14.8|0.438
91754587|NCT04557787|183401849|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.955|TWO_SIDED|95.0|-10.3|10.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||10.9|-10.3|0.955
91754588|NCT04557787|183401849|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.118|TWO_SIDED|95.0|-19.2|2.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||2.2|-19.2|0.118
91754589|NCT04557787|183401849|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.104|TWO_SIDED|95.0|-1.8|19.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.5|-1.8|0.104
91754590|NCT04557787|183401850|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.352|TWO_SIDED|95.0|-0.22|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.22|0.352
91754591|NCT04557787|183401850|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.41|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.41|0.980
91754592|NCT04557787|183401850|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.21|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.21|0.339
91754593|NCT04557787|183401851|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.62|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.62|0.700
91508526|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.025||0.135|TWO_SIDED|95.0|-3.56|0.49||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 4||0.49|-3.56|0.135
91508527|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.09||0.067|TWO_SIDED|95.0|-4.17|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 5||0.14|-4.17|0.067
91508528|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.119||0.092|TWO_SIDED|95.0|-4.11|0.31||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 6||0.31|-4.11|0.092
91508529|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.566||0.548|TWO_SIDED|95.0|-0.78|1.46||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 1||1.46|-0.78|0.548
91508530|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.756||0.42|TWO_SIDED|95.0|-2.11|0.88||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 2||0.88|-2.11|0.420
91508531|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.818||0.857|TWO_SIDED|95.0|-1.47|1.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 3||1.76|-1.47|0.857
91754594|NCT04557787|183401851|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.227|TWO_SIDED|95.0|-0.2|0.84||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.84|-0.20|0.227
91754595|NCT04557787|183401851|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.112|TWO_SIDED|95.0|-0.94|0.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.10|-0.94|0.112
91754596|NCT04557787|183401852|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.013|TWO_SIDED|95.0|0.22|1.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.17|0.22|0.013
91754597|NCT04557787|183401852|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.065|TWO_SIDED|95.0|-0.05|1.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.51|-0.05|0.065
91754598|NCT04557787|183401852|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.497|TWO_SIDED|95.0|-0.51|1.04||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.04|-0.51|0.497
91754599|NCT04557787|183401853|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.027|TWO_SIDED|95.0|0.06|0.88||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.88|0.06|0.027
91754600|NCT04557787|183401853|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.005|TWO_SIDED|95.0|0.19|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|0.19|0.005
91754601|NCT04557787|183401853|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.532|TWO_SIDED|95.0|-0.54|0.28||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.28|-0.54|0.532
91754602|NCT04557787|183401854|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.26|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-0.26|0.461
91508532|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.936||0.527|TWO_SIDED|95.0|-2.44|1.26||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 4||1.26|-2.44|0.527
91508533|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.94||0.875|TWO_SIDED|95.0|-2.01|1.71||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 5||1.71|-2.01|0.875
91508534|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.94||0.441|TWO_SIDED|95.0|-2.58|1.13||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 6||1.13|-2.58|0.441
91508535|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.406||0.362|TWO_SIDED|95.0|-1.17|0.43||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 1||0.43|-1.17|0.362
91508536|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.53||0.687|TWO_SIDED|95.0|-1.26|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 2||0.83|-1.26|0.687
91754603|NCT04557787|183401854|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.12|TWO_SIDED|95.0|-0.09|0.73||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.73|-0.09|0.120
91754604|NCT04557787|183401854|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.404|TWO_SIDED|95.0|-0.58|0.24||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.24|-0.58|0.404
91754605|NCT04557787|183401855|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.478|TWO_SIDED|95.0|-0.33|0.71||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.71|-0.33|0.478
91754606|NCT04557787|183401855|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.824|TWO_SIDED|95.0|-0.46|0.58||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.58|-0.46|0.824
91508537|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.618||0.458|TWO_SIDED|95.0|-1.68|0.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 3||0.76|-1.68|0.458
91508538|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.704||0.991|TWO_SIDED|95.0|-1.38|1.4||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 4||1.40|-1.38|0.991
91508539|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.782||0.354|TWO_SIDED|95.0|-2.27|0.82||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 5||0.82|-2.27|0.354
91508540|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.804||0.119|TWO_SIDED|95.0|-2.85|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 6||0.33|-2.85|0.119
91754607|NCT04557787|183401855|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.626|TWO_SIDED|95.0|-0.39|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-0.39|0.626
91754608|NCT04557787|183401856|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.03|TWO_SIDED|95.0|0.09|1.64||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.64|0.09|0.030
91508541|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.469||0.493|TWO_SIDED|95.0|-1.25|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 1||0.60|-1.25|0.493
91508542|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.504||0.949|TWO_SIDED|95.0|-0.96|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 2||1.03|-0.96|0.949
91532821|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.5||||0.147|TWO_SIDED|90.0|-1.07|0.07||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-1.07|0.147
91532822|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.42||||0.21|TWO_SIDED|90.0|-0.98|0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.98|0.210
91508543|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.604||0.153|TWO_SIDED|95.0|-2.06|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 3||0.33|-2.06|0.153
91754609|NCT04557787|183401856|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.027|TWO_SIDED|95.0|0.11|1.66||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.66|0.11|0.027
91754610|NCT04557787|183401856|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.956|TWO_SIDED|95.0|-0.8|0.75||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.75|-0.80|0.956
91754611|NCT04557787|183401857|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.084|TWO_SIDED|95.0|-0.05|0.78||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.78|-0.05|0.084
91754612|NCT04557787|183401857|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.063|TWO_SIDED|95.0|-0.02|0.81||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.81|-0.02|0.063
91754613|NCT04557787|183401857|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.885|TWO_SIDED|95.0|-0.44|0.38||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.38|-0.44|0.885
91754614|NCT04135859|183401888|SUPERIORITY||Mean Difference (Final Values)|10.3||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||.023
91754615|NCT04135859|183401889|SUPERIORITY||Mean Difference (Final Values)|-59.0||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
91754616|NCT04135859|183401890|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.43|TWO_SIDED||||||Mixed Models Analysis|||||||.43
91759682|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|6.63|42.24|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||42.24|6.63|
91759683|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.99|||||TWO_SIDED|95.0|9.33|44.65|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||44.65|9.33|
91759684|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-7.53|25.31|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||25.31|-7.53|
91759685|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.4|||||TWO_SIDED|95.0|3.88|38.91|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||38.91|3.88|
91759686|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-6.8|24.57|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||24.57|-6.80|
91759687|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.58|||||TWO_SIDED|95.0|1.96|35.2|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||35.20|1.96|
91759688|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|35.55|||||TWO_SIDED|95.0|17.89|53.21|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||53.21|17.89|
91759689|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|29.21|||||TWO_SIDED|95.0|11.94|46.49|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||46.49|11.94|
91532823|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.28||||0.438|TWO_SIDED|90.0|-0.86|0.31||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.31|-0.86|0.438
91754617|NCT01291836|183401896|SUPERIORITY_OR_OTHER_LEGACY||Area under Receiver-Operator Curve (ROC)|0.658|||||TWO_SIDED|95.0|0.586|0.73||||||Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.73|0.586|
91754618|NCT01291836|183401897|SUPERIORITY_OR_OTHER_LEGACY||ROC AUC|0.65|||||TWO_SIDED|95.0|0.598|0.702||||||Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.702|0.598|
91754619|NCT02855944|183401952|SUPERIORITY||Cox Proportional Hazard|0.639||||0.001|TWO_SIDED|95.0|0.489|0.835|||Regression, Cox|||||0.835|0.489|0.0010
91754620|NCT02855944|183401953|SUPERIORITY||Cox Proportional Hazard|0.665||||0.0017|TWO_SIDED|95.0|0.516|0.858|||Regression, Cox|||||0.858|0.516|0.0017
91754621|NCT02855944|183401956|SUPERIORITY||Cox Proportional Hazard|0.589||||0.0401|TWO_SIDED|95.0|0.356|0.976|||Regression, Cox|||||0.976|0.356|0.0401
91754622|NCT02855944|183401957|SUPERIORITY||Cox Proportional Hazard|0.564||||0.024|TWO_SIDED|95.0|0.343|0.927|||Regression, Cox|||||0.927|0.343|0.0240
91754623|NCT00966719|183401980|OTHER||Risk Ratio (RR)|0.84||||0.4|TWO_SIDED|95.0|0.56|1.24|||Fisher Exact|||||1.24|0.56|0.40
91754624|NCT00966719|183401981|OTHER||Risk Ratio (RR)|1.15||||1|TWO_SIDED|95.0|0.44|3.02|||Fisher Exact|||||3.02|0.44|1
91754625|NCT00966719|183401982|OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.91|1.1|||Fisher Exact|||||1.10|0.91|1
91754626|NCT00966719|183401983|OTHER||Risk Ratio (RR)|1.03||||0.78|TWO_SIDED|95.0|0.85|1.26|||Fisher Exact|||||1.26|0.85|0.78
91754627|NCT00966719|183401984|OTHER||Risk Ratio (RR)|2.94||||0.32|TWO_SIDED|95.0|0.32|27.3|||Fisher Exact|||||27.30|0.32|0.32
91754628|NCT00966719|183401985|OTHER||Risk Ratio (RR)|1.5||||0.09|TWO_SIDED|95.0|0.95|2.38|||Fisher Exact|||||2.38|0.95|0.09
91754629|NCT00966719|183401986|OTHER||Risk Ratio (RR)|1.03||||0.77|TWO_SIDED|95.0|0.83|1.27|||Fisher Exact|||||1.27|0.83|0.77
91754630|NCT00966719|183401987|OTHER||Risk Ratio (RR)|1.36||||0.6|TWO_SIDED|95.0|0.58|3.15|||Fisher Exact|||||3.15|0.58|0.6
91754631|NCT03242018|183401998|SUPERIORITY||Difference in Least Square (LS) Means|-0.29|STANDARD_ERROR_OF_MEAN|0.173||0.0962|TWO_SIDED|95.0|-0.628|0.051|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.051|-0.628|0.0962
91754632|NCT03242018|183401999|SUPERIORITY||Difference in LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.196||0.8124|TWO_SIDED|95.0|-0.338|0.431|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.431|-0.338|0.8124
91754633|NCT03242018|183402000|SUPERIORITY||Difference in LS Means|-0.361|STANDARD_ERROR_OF_MEAN|0.6033||0.5501|TWO_SIDED|95.0|-1.5431|0.822|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.8220|-1.5431|0.5501
91754634|NCT03242018|183402000|SUPERIORITY||Difference in LS Means|-0.714|STANDARD_ERROR_OF_MEAN|0.5298||0.1779|TWO_SIDED|95.0|-1.7524|0.3246|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.3246|-1.7524|0.1779
91754635|NCT03242018|183402001|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.703||0.2432|TWO_SIDED|95.0|-2.197|0.557|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||0.557|-2.197|0.2432
91759690|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.33|||||TWO_SIDED|95.0|-2.96|29.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||29.63|-2.96|
91759691|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|32.31|||||TWO_SIDED|95.0|14.83|49.8|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||49.80|14.83|
91759692|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-15.79|15.79|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.79|-15.79|
91759693|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.49|||||TWO_SIDED|95.0|-12.67|19.67|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||19.67|-12.67|
91759694|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.66|||||TWO_SIDED|95.0|-10.13|23.47|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||23.47|-10.13|
91759695|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.75|||||TWO_SIDED|95.0|-16.25|14.74|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||14.74|-16.25|
91508544|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.681||0.994|TWO_SIDED|95.0|-1.34|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 4||1.35|-1.34|0.994
91508545|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.679||0.365|TWO_SIDED|95.0|-1.96|0.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 5||0.73|-1.96|0.365
91508546|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.653||0.088|TWO_SIDED|95.0|-2.41|0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 6||0.17|-2.41|0.088
91508547|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.397||0.535|TWO_SIDED|95.0|-0.54|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 1||1.03|-0.54|0.535
91508548|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.502||0.412|TWO_SIDED|95.0|-1.4|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 2||0.58|-1.40|0.412
91508549|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.522||0.354|TWO_SIDED|95.0|-1.52|0.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 3||0.55|-1.52|0.354
91508550|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.59||0.589|TWO_SIDED|95.0|-1.49|0.85||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 4||0.85|-1.49|0.589
91508551|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.569||0.36|TWO_SIDED|95.0|-1.65|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 5||0.60|-1.65|0.360
91508552|NCT02477020|182889186|SUPERIORITY_OR_OTHER||Least square mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.635||0.288|TWO_SIDED|95.0|-1.93|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 6||0.58|-1.93|0.288
91508553|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.59||0.238|TWO_SIDED|95.0|-1.87|0.47||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 1||0.47|-1.87|0.238
91754636|NCT03242018|183402001|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.715||0.0487|TWO_SIDED|95.0|-2.81|-0.008|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.008|-2.810|0.0487
91508554|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.784||0.359|TWO_SIDED|95.0|-2.27|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 2||0.83|-2.27|0.359
91508555|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.943||0.119|TWO_SIDED|95.0|-3.34|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 3||0.38|-3.34|0.119
91754637|NCT03242018|183402002|SUPERIORITY||Difference in LS Means|-2.14|STANDARD_ERROR_OF_MEAN|2.515||0.3954|TWO_SIDED|95.0|-7.066|2.792|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||2.792|-7.066|0.3954
91759696|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-8.19|25.96|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||25.96|-8.19|
91508556|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.014||0.238|TWO_SIDED|95.0|-3.21|0.8||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 4||0.80|-3.21|0.238
91508557|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.73|STANDARD_ERROR_OF_MEAN|1.051||0.102|TWO_SIDED|95.0|-3.81|0.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 5||0.35|-3.81|0.102
91508558|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.094||0.145|TWO_SIDED|95.0|-3.77|0.56||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 6||0.56|-3.77|0.145
91508559|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.504||0.902|TWO_SIDED|95.0|-0.93|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 1||1.06|-0.93|0.902
91508560|NCT02477020|182889187|SUPERIORITY_OR_OTHER||MMRM|-0.59|STANDARD_ERROR_OF_MEAN|0.693||0.396|TWO_SIDED|95.0|-1.96|0.78||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 2||0.78|-1.96|0.396
91508561|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.722||0.612|TWO_SIDED|95.0|-1.79|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 3||1.06|-1.79|0.612
91508562|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.856||0.67|TWO_SIDED|95.0|-2.06|1.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 4||1.33|-2.06|0.670
91508563|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.892||0.807|TWO_SIDED|95.0|-1.98|1.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 5||1.55|-1.98|0.807
91508564|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.14|STANDARD_ERROR_OF_MEAN|0.853||0.182|TWO_SIDED|95.0|-2.83|0.54||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 6||0.54|-2.83|0.182
91508565|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.801||0.933|TWO_SIDED|95.0|-1.52|1.65||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 1||1.65|-1.52|0.933
91508566|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|1.151||0.596|TWO_SIDED|95.0|-2.89|1.66||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 2||1.66|-2.89|0.596
91532824|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.7||||0.043|TWO_SIDED|90.0|-1.28|-0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.13|-1.28|0.043
91508567|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.31|STANDARD_ERROR_OF_MEAN|1.455||0.371|TWO_SIDED|95.0|-4.18|1.57||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 3||1.57|-4.18|0.371
91759697|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.13|||||TWO_SIDED|95.0|-10.5|22.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||22.77|-10.50|
91759698|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.01|||||TWO_SIDED|95.0|-28.03|-2.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-2.00|-28.03|
91759699|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.86|||||TWO_SIDED|95.0|-24.93|3.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.19|-24.93|
91508568|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|1.625||0.821|TWO_SIDED|95.0|-3.58|2.84||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 4||2.84|-3.58|0.821
91508569|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-1.61|STANDARD_ERROR_OF_MEAN|1.621||0.323|TWO_SIDED|95.0|-4.81|1.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 5||1.60|-4.81|0.323
91508570|NCT02477020|182889187|SUPERIORITY_OR_OTHER||Least square mean difference|-2.44|STANDARD_ERROR_OF_MEAN|1.732||0.161|TWO_SIDED|95.0|-5.87|0.98||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 6||0.98|-5.87|0.161
91508571|NCT02477020|182889188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.664||||0.017|TWO_SIDED|95.0|1.263|10.624|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 1||10.624|1.263|0.017
91508572|NCT02477020|182889188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.782||||0.009|TWO_SIDED|95.0|1.287|6.014|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 2||6.014|1.287|0.009
91754638|NCT03242018|183402002|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|2.442||0.0716|TWO_SIDED|95.0|-9.185|0.386|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.386|-9.185|0.0716
91532825|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.24||||0.403|TWO_SIDED|90.0|-0.23|0.72||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.72|-0.23|0.403
91508573|NCT02477020|182889188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.818||||0.108|TWO_SIDED|95.0|0.877|3.771|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 3||3.771|0.877|0.108
91754639|NCT03242018|183402003|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|2.103||0.1232|TWO_SIDED|95.0|-7.365|0.881|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.881|-7.365|0.1232
91508574|NCT02477020|182889188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.222||||0.596|TWO_SIDED|95.0|0.583|2.561|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 4||2.561|0.583|0.596
91508575|NCT02477020|182889188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.542||||0.263|TWO_SIDED|95.0|0.722|3.292|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 5||3.292|0.722|0.263
91508576|NCT02477020|182889188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.253||95.0|0.725|3.388|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 6||3.388|0.725|0.253
91508577|NCT02477020|182889189|SUPERIORITY_OR_OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.095||0.619|TWO_SIDED|95.0|-0.23|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 1||0.14|-0.23|0.619
91508578|NCT02477020|182889189|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.136||0.116|TWO_SIDED|95.0|-0.48|0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 2||0.05|-0.48|0.116
91508579|NCT02477020|182889189|SUPERIORITY_OR_OTHER||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.166||0.009|TWO_SIDED|95.0|-0.77|-0.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 3||-0.11|-0.77|0.009
91754640|NCT03242018|183402003|SUPERIORITY||Difference in LS Means|-5.36|STANDARD_ERROR_OF_MEAN|2.077||0.0098|TWO_SIDED|95.0|-9.433|-1.292|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.292|-9.433|0.0098
91754641|NCT03242018|183402004|SUPERIORITY||Percent Difference|-20.37||||0.222|TWO_SIDED|95.0|-44.75|14.77|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||14.77|-44.75|0.222
91754642|NCT03242018|183402004|SUPERIORITY||Percent Difference|-21.17||||0.1965|TWO_SIDED|95.0|-45.05|13.1|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||13.10|-45.05|0.1965
91754643|NCT03242018|183402005|SUPERIORITY||Percentage Difference|3.2||||0.242|TWO_SIDED|95.0|-2.17|8.66|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||8.66|-2.17|0.2420
91754644|NCT03242018|183402005|SUPERIORITY||Percentage Difference|6.5||||0.0513|TWO_SIDED|95.0|0.04|12.93|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||12.93|0.04|0.0513
91754645|NCT03242018|183402006|SUPERIORITY||Percentage Difference|12.0||||0.0066|TWO_SIDED|95.0|3.48|20.61|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||20.61|3.48|0.0066
91754646|NCT03242018|183402006|SUPERIORITY||Percentage Difference|13.0||||0.0043|TWO_SIDED|95.0|4.28|21.75|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||21.75|4.28|0.0043
91754647|NCT01852383|183402011|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
91754648|NCT01852383|183402012|SUPERIORITY_OR_OTHER||||||<|0.1||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|Corrlation|||||||<0.1
91754649|NCT01852383|183402013|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
91754650|NCT01852383|183402014|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.|Pearson correlation|||Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.||||<.001
91754651|NCT02968914|183402032|SUPERIORITY||Geometric mean ratio (%)|94.46|||||TWO_SIDED|90.0|88.16|101.21|||ANOVA|||||101.21|88.16|
91754652|NCT02968914|183402033|SUPERIORITY||Geometric mean ratio (%)|92.83|||||TWO_SIDED|90.0|87.41|98.58|||ANOVA|||||98.58|87.41|
91754653|NCT02968914|183402034|SUPERIORITY||Geometric mean ratio (%)|92.34|||||TWO_SIDED|90.0|86.34|98.75|||ANOVA|||||98.75|86.34|
91754654|NCT00576472|183402136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|-0.0452|-0.0208|||ANOVA|||||-0.0208|-0.0452|<.0001
91754655|NCT00576472|183402137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0285|STANDARD_ERROR_OF_MEAN|0.0046|<|0.0001|TWO_SIDED|95.0|0.019|0.038|||ANOVA|||||0.0380|0.0190|<.0001
91754656|NCT00576472|183402138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0144|STANDARD_ERROR_OF_MEAN|0.0064||0.025|TWO_SIDED|95.0|0.000204|0.0285|||ANOVA|||||0.0285|0.000204|0.025
91754657|NCT00576472|183402138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0442|STANDARD_ERROR_OF_MEAN|0.0093|<|0.0001|TWO_SIDED|95.0|0.0292|0.0591|||ANOVA|||||0.0591|0.0292|<.0001
91754658|NCT00576472|183402138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0491|STANDARD_ERROR_OF_MEAN|0.0064|<|0.0001|TWO_SIDED|95.0|0.0396|0.0586|||ANOVA|||||0.0586|0.0396|<.0001
91754659|NCT00576472|183402138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0298|STANDARD_ERROR_OF_MEAN|0.0083||0.0004|TWO_SIDED|95.0|0.00974|0.0499|||ANOVA|||||0.0499|0.00974|.0004
91754660|NCT00576472|183402138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0347|STANDARD_ERROR_OF_MEAN|0.0047|<|0.0001|TWO_SIDED|95.0|0.025|0.0445|||ANOVA|||||0.0445|0.0250|<.0001
91754661|NCT00576472|183402138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00494|STANDARD_ERROR_OF_MEAN|0.0083||0.552|TWO_SIDED|95.0|-0.00865|0.0185|||ANOVA|||||0.0185|-0.00865|.552
91754662|NCT00576472|183402139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.17|STANDARD_ERROR_OF_MEAN|1.93||0.0005|TWO_SIDED|95.0|-11.0|-3.3|||ANOVA|||||-3.3|-11.0|.0005
91754663|NCT00576472|183402140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.59||0.0413|TWO_SIDED|95.0|-6.5|-0.1|||ANOVA|||||-0.1|-6.5|0.0413
91754664|NCT00576472|183402141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-11.0|-6.4|||ANOVA|||||-6.4|-11.0|<.0001
91754665|NCT00576472|183402142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-12.0|-7.0|||ANOVA|||||-7.0|-12.0|<.0001
91754666|NCT00576472|183402143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|4.4|11.6|||ANOVA|||||11.6|4.4|<.0001
91754667|NCT00576472|183402144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.03||0.8425|TWO_SIDED|95.0|-2.3|1.9|||ANOVA|||||1.9|-2.3|.8425
91754668|NCT00576472|183402145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.73||0.0016|TWO_SIDED|95.0|-3.9|-0.9|||ANOVA|||||-0.9|-3.9|.0016
91754669|NCT00576472|183402146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|1.04||0.8329|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|||||2.3|-1.9|.8329
91754670|NCT00576472|183402148|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||||||0.0077
91754671|NCT00576472|183402148|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91754672|NCT00576472|183402148|SUPERIORITY_OR_OTHER|||||||0.1408||95.0|||||t-test, 2 sided|||||||0.1408
91754673|NCT00576472|183402149|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
91754674|NCT00576472|183402149|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||t-test, 2 sided|||||||0.0058
91754675|NCT00576472|183402149|SUPERIORITY_OR_OTHER|||||||0.4258||95.0|||||t-test, 2 sided|||||||0.4258
91754676|NCT00576472|183402150|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
91754677|NCT00576472|183402150|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
91754678|NCT00576472|183402150|SUPERIORITY_OR_OTHER|||||||0.4086||95.0|||||t-test, 2 sided|||||||0.4086
91754679|NCT00576472|183402151|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
91754680|NCT00576472|183402151|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||t-test, 2 sided|||||||0.0007
91754681|NCT00576472|183402151|SUPERIORITY_OR_OTHER|||||||0.7007||95.0|||||t-test, 2 sided|||||||0.7007
91754682|NCT00576472|183402152|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
91754683|NCT00576472|183402152|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||t-test, 2 sided|||||||0.0016
91754684|NCT00576472|183402152|SUPERIORITY_OR_OTHER|||||||0.6237||95.0|||||t-test, 2 sided|||||||0.6237
91754685|NCT00576472|183402153|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
91754686|NCT00576472|183402153|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
91754687|NCT00576472|183402153|SUPERIORITY_OR_OTHER|||||||0.6071||95.0|||||t-test, 2 sided|||||||0.6071
91754688|NCT00576472|183402154|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||t-test, 2 sided|||||||0.1386
91754689|NCT00576472|183402154|SUPERIORITY_OR_OTHER|||||||0.0905||95.0|||||t-test, 2 sided|||||||0.0905
91754690|NCT00576472|183402154|SUPERIORITY_OR_OTHER|||||||0.8039||95.0|||||t-test, 2 sided|||||||0.8039
91754691|NCT00576472|183402155|SUPERIORITY_OR_OTHER|||||||0.7496||95.0|||||t-test, 2 sided|||||||0.7496
91754692|NCT00576472|183402155|SUPERIORITY_OR_OTHER|||||||0.9489||95.0|||||t-test, 2 sided|||||||0.9489
91754693|NCT00576472|183402155|SUPERIORITY_OR_OTHER|||||||0.7021||95.0|||||t-test, 2 sided|||||||0.7021
91754694|NCT00576472|183402156|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|||||||0.0190
91754695|NCT00576472|183402156|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
91754696|NCT00576472|183402156|SUPERIORITY_OR_OTHER|||||||0.1622||95.0|||||t-test, 2 sided|||||||0.1622
91754697|NCT00576472|183402157|SUPERIORITY_OR_OTHER|||||||0.1202||95.0|||||t-test, 2 sided|||||||0.1202
91754698|NCT00576472|183402157|SUPERIORITY_OR_OTHER|||||||0.0103||95.0|||||t-test, 2 sided|||||||0.0103
91754699|NCT00576472|183402157|SUPERIORITY_OR_OTHER|||||||0.2831||95.0|||||t-test, 2 sided|||||||0.2831
91754700|NCT00576472|183402158|SUPERIORITY_OR_OTHER|||||||0.7027||95.0|||||t-test, 2 sided|||||||0.7027
91754701|NCT00576472|183402159|SUPERIORITY_OR_OTHER|||||||0.7493||95.0|||||t-test, 2 sided|||||||0.7493
91754702|NCT00576472|183402160|SUPERIORITY_OR_OTHER|||||||0.7339||95.0|||||t-test, 2 sided|||||||0.7339
91754703|NCT00576472|183402161|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||t-test, 2 sided|||||||0.6148
91754704|NCT00576472|183402162|SUPERIORITY_OR_OTHER|||||||0.4456||95.0|||||t-test, 2 sided|||||||0.4456
91754705|NCT00576472|183402163|SUPERIORITY_OR_OTHER|||||||0.5866||95.0|||||t-test, 2 sided|||||||0.5866
91754706|NCT00576472|183402164|SUPERIORITY_OR_OTHER|||||||0.8918||95.0|||||t-test, 2 sided|||||||0.8918
91754707|NCT00576472|183402165|SUPERIORITY_OR_OTHER|||||||0.4427||95.0|||||t-test, 2 sided|||||||0.4427
91754708|NCT00576472|183402166|SUPERIORITY_OR_OTHER|||||||0.4203||95.0|||||t-test, 2 sided|||||||0.4203
91754709|NCT00576472|183402167|SUPERIORITY_OR_OTHER|||||||0.5754||95.0|||||t-test, 2 sided|||||||0.5754
91754710|NCT00576472|183402168|SUPERIORITY_OR_OTHER|||||||0.0251||95.0|||||t-test, 2 sided|||||||0.0251
91754711|NCT00576472|183402169|SUPERIORITY_OR_OTHER|||||||0.1049||95.0|||||t-test, 2 sided|||||||0.1049
91754712|NCT04405245|183402170|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.366||0.807|TWO_SIDED|95.0|-0.63|0.81|||ANCOVA|||||0.81|-0.63|0.8070
91754713|NCT04405245|183402170|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.365||0.013|TWO_SIDED|95.0|-1.64|-0.2|||ANCOVA|||||-0.20|-1.64|0.0130
91754714|NCT02576860|183402198|SUPERIORITY|||||||0.799|||||||ANCOVA|||||||0.799
91754715|NCT02576860|183402199|SUPERIORITY|||||||0.858|||||||Cochran-Mantel-Haenszel|||||||0.858
91754716|NCT02391961|183402208|SUPERIORITY|||||||0.842672|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PSR at baseline and after 3 hours on dalfampridine, and average PSR at baseline and after 3 hours on placebo.||||0.842672
91754717|NCT02391961|183402209|SUPERIORITY|||||||0.972866|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PTD at baseline and after 3 hours on dalfampridine, and average PTD at baseline and after 3 hours on placebo.||||0.972866
91754718|NCT02391961|183402210|SUPERIORITY|||||||0.95|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: RA at baseline and after 3 hours on dalfampridine, and RA at baseline and after 3 hours on placebo.||||0.95
91754719|NCT02391961|183402211|SUPERIORITY|||||||0.9|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: MRS at baseline and after 3 hours on dalfampridine, and MRS at baseline and after 3 hours on placebo.||||0.9
91754720|NCT02391961|183402212|SUPERIORITY|||||||0.990995|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: 25 FWT at baseline and after 3 hours on dalfampridine, and 25 FWT at baseline and after 3 hours on placebo.||||0.990995
91754721|NCT02391961|183402213|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean VFQ-25 scores on dalfampridine vs mean VFQ-25 scores on placebo||||0.71
91754722|NCT02391961|183402214|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean 10-item NOS scores on dalfampridine vs mean 10-item NOS scores on placebo||||0.95
91754723|NCT02011490|183402241|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.42|||||TWO_SIDED|90.0|4.12|7.11|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an analysis of variance (ANOVA) linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.11|4.12|
91754724|NCT02011490|183402241|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.17|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.17|1.84|
91754725|NCT02011490|183402242|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.49|||||TWO_SIDED|90.0|4.18|7.22|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.22|4.18|
91754726|NCT02011490|183402242|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.18|1.84|
91754727|NCT02011490|183402243|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|90.0|0.73|1.21|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.21|0.73|
91754728|NCT02011490|183402243|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.92|||||TWO_SIDED|90.0|0.72|1.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.18|0.72|
91754729|NCT01014455|183402255|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
91754730|NCT00249613|183402259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.21|0.79||Odds ratio is 0.40, confidence interval is 0.21-0.79.|Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only participants are less likely than Mixed-Gender participants to engage in criminal activities.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.79|0.21|0.01
91754731|NCT00249613|183402260|SUPERIORITY_OR_OTHER||Beta coefficient|-0.7|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.11|0.7|||Generalized estimating equations (GEE)|||Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.||0.70|-2.11|0.33
91754732|NCT00249613|183402261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.22|0.82|||Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only treatment participants are less likely than the Mixed-Gender group to use drugs or alcohol during the 30 days prior to the 12-Mo follow-up.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.82|0.22|0.01
91754733|NCT01184417|183402263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||||TWO_SIDED|95.0|4.0|32.0||||||||32|4|
91754734|NCT01184417|183402264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|4.0|49.0||||||||49|4|
91754735|NCT01184417|183402265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.0|||||TWO_SIDED|95.0|-4.0|82.0||||||||82|-4|
91754736|NCT01184417|183402267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-11.0|23.0||||||||23|-11|
91754737|NCT04728594|183402278|SUPERIORITY||Odds Ratio (OR)|2.11|||<|0.001|TWO_SIDED|95.0|1.65|2.69||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.69|1.65|<.001
91754738|NCT04728594|183402278|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.77|2.87||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.87|1.77|<.001
91754739|NCT04728594|183402278|SUPERIORITY||Odds Ratio (OR)|1.07|||<|0.001|TWO_SIDED|95.0|0.88|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||1.30|0.88|<.001
91754740|NCT00128713|183402314|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
91754741|NCT00128713|183402314|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
91754742|NCT00128713|183402314|SUPERIORITY_OR_OTHER|||||||0.66||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.66
91754743|NCT00128713|183402315|SUPERIORITY_OR_OTHER|||||||0.02||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.02
91754744|NCT00128713|183402315|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91754745|NCT00128713|183402315|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91754746|NCT00128713|183402316|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91754747|NCT00128713|183402316|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91754748|NCT00128713|183402316|SUPERIORITY_OR_OTHER|||||||0.16||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.16
91754749|NCT00128713|183402318|SUPERIORITY_OR_OTHER|||||||0.51||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.51
91754750|NCT00128713|183402318|SUPERIORITY_OR_OTHER|||||||0.82||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.82
91754751|NCT00128713|183402318|SUPERIORITY_OR_OTHER|||||||0.68||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.68
91754752|NCT01755455|183402387|SUPERIORITY_OR_OTHER|||||||0.81|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||0.81
91754753|NCT01755455|183402388|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||||||<0.05
91754754|NCT01755455|183402389|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||<0.05
91754755|NCT01755455|183402390|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fixed-effect model|||||||0.16
91754756|NCT00344500|183402404|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Predicted trajectory of mean weight change between matched UC and LB subjects over 12 months (treatment\*time interaction: F(1,1275)=68.75, p\<.01).||General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.||||<0.01
91754757|NCT00599755|183402407|SUPERIORITY_OR_OTHER||Proportion|0.4|||||TWO_SIDED|80.0|0.27|0.55||||||||0.55|0.27|
91754758|NCT00599755|183402408|SUPERIORITY_OR_OTHER||Concordance correlation coefficient|0.88|||||TWO_SIDED|80.0|0.85|0.92||||||||0.92|0.85|
91754759|NCT00599755|183402412|SUPERIORITY_OR_OTHER||Proportion|0.125|||||TWO_SIDED|80.0|0.06|0.23||||||||0.23|0.06|
91754760|NCT02198794|183402427|OTHER||Least Square (LS) Mean Difference|-0.6||||0.121|TWO_SIDED|95.0|-1.42|0.17||Threshold for significance at 0.05 level.|ANCOVA|||The statistical model was an analysis of covariance (ANCOVA) with treatment group and dopamine receptor antagonist status at the pre-withdrawal visit as fixed effects and the pre-withdrawal visit value as a covariate.||0.17|-1.42|0.121
91754761|NCT01364740|183402442|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
91754762|NCT01364740|183402443|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
91754763|NCT01364740|183402444|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
91754764|NCT01364740|183402445|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
91754765|NCT00789672|183402478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_DEVIATION|4.7|||TWO_SIDED|95.0|-6.0|1.0||||||Given this was pilot study, no formal sample size estimates were calculated.||1|-6|
91754766|NCT02252965|183402484|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of this efficacy outcome measure is -0.4%.|Least Squares (LS) Mean Difference|0.03|||||TWO_SIDED|95.0|-0.1|0.17||||||||0.17|-0.10|
91754767|NCT02252965|183402485|SUPERIORITY_OR_OTHER||Percentage difference|-1.52||||0.674|TWO_SIDED|95.0|-8.6|5.56|||Mantel Haenszel|||||5.56|-8.60|0.674
91754768|NCT00680797|183402495|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED|||||Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.023
91754769|NCT00680797|183402495|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Comparison in the change in insulin levels between the groups receiving E with or without T.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.042
91759700|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.67|||||TWO_SIDED|95.0|-24.83|3.48|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.48|-24.83|
91759701|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.96|||||TWO_SIDED|95.0|-10.96|22.9|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||22.90|-10.96|
91759702|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-21.54|||||TWO_SIDED|95.0|-37.22|-5.86|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-5.86|-37.22|
91759703|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.03|||||TWO_SIDED|95.0|-25.01|10.95|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||10.95|-25.01|
91508580|NCT02477020|182889189|SUPERIORITY_OR_OTHER||Least square mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.049|TWO_SIDED|95.0|-0.72|0.0||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 4||0.00|-0.72|0.049
91532826|NCT01027871|182942390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.314|TWO_SIDED|90.0|-0.75|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.75|0.314
91754770|NCT04736628|183402496|OTHER||Mean Difference (Net)|-0.228||||0.0179|TWO_SIDED|95.0|-0.417|-0.04|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.040|-0.417|0.0179
91754771|NCT04736628|183402496|OTHER||Mean Difference (Net)|-0.209||||0.0307|TWO_SIDED|95.0|-0.398|-0.02|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.020|-0.398|0.0307
91754772|NCT04736628|183402496|OTHER||Mean Difference (Net)|-0.235||||0.0151|TWO_SIDED|95.0|-0.425|-0.046|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.046|-0.425|0.0151
91754773|NCT04736628|183402496|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0053|||||||MCP-Mod E-max model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0053
91754774|NCT04736628|183402496|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0102|||||||MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0102
91754775|NCT04736628|183402496|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.023|||||||MCP-Mod linear model fit|Model assumption: no assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0230
91754776|NCT04736628|183402496|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0292|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0292
91759704|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.12|||||TWO_SIDED|95.0|-14.17|24.41|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||24.41|-14.17|
91759705|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-21.22|15.67|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.67|-21.22|
91759706|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-25.84|||||TWO_SIDED|95.0|-42.54|-9.14|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-9.14|-42.54|
91532827|NCT01027871|182942392|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.046
91754777|NCT04736628|183402496|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0468|||||||MCP-Mod Exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0468
91754778|NCT04736628|183402497|OTHER||Mean Difference (Net)|-0.217||||0.0327|TWO_SIDED|95.0|-0.416|-0.018|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.018|-0.416|0.0327
91754779|NCT04736628|183402497|OTHER||Mean Difference (Net)|-0.206||||0.0447|TWO_SIDED|95.0|-0.408|-0.005|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.005|-0.408|0.0447
91754780|NCT04736628|183402497|OTHER||Mean Difference (Net)|-0.187||||0.0654|TWO_SIDED|95.0|-0.387|0.012|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||0.012|-0.387|0.0654
91754781|NCT04736628|183402498|OTHER||Odds Ratio (OR)|2.2||||0.0476|TWO_SIDED|95.0|1.01|4.79||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.79|1.01|0.0476
91754782|NCT04736628|183402498|OTHER||Odds Ratio (OR)|2.72||||0.0119|TWO_SIDED|95.0|1.25|5.94||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||5.94|1.25|0.0119
91532828|NCT01027871|182942392|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.224
91754783|NCT04736628|183402498|OTHER||Odds Ratio (OR)|3.43||||0.0019|TWO_SIDED|95.0|1.58|7.45||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||7.45|1.58|0.0019
91508581|NCT02477020|182889189|SUPERIORITY_OR_OTHER||Least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.191||0.016|TWO_SIDED|95.0|-0.85|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 5||-0.09|-0.85|0.016
91508582|NCT02477020|182889189|SUPERIORITY_OR_OTHER||Least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.202||0.035||95.0|-0.83|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 6||-0.03|-0.83|0.035
91508583|NCT02477020|182889190|SUPERIORITY_OR_OTHER||Least square mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.128||0.746|TWO_SIDED|95.0|-0.29|0.21||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 1||0.21|-0.29|0.746
91508584|NCT02477020|182889190|SUPERIORITY_OR_OTHER||Least mean square difference|-0.37|STANDARD_ERROR_OF_MEAN|0.173||0.034|TWO_SIDED|95.0|-0.72|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 2||-0.03|-0.72|0.034
91532829|NCT01027871|182942393|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.561
91754784|NCT04736628|183402499|OTHER||Odds Ratio (OR)|2.13||||0.0497|TWO_SIDED|95.0|1.0|4.55||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.55|1.00|0.0497
91754785|NCT04736628|183402499|OTHER||Odds Ratio (OR)|2.15||||0.0502|TWO_SIDED|95.0|1.0|4.61||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.61|1.00|0.0502
91754786|NCT04736628|183402499|OTHER||Odds Ratio (OR)|2.09||||0.0572|TWO_SIDED|95.0|0.98|4.49||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.49|0.98|0.0572
91754787|NCT04051827|183402506|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.739|1.42|||||The geometric mean ratio (GMR) of midazolam Cmax on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90 percent (%) confidence intervals (CIs) were calculated on the basis of the within-patient variance using a mixed-effects analysis of variance (ANOVA) model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.42|0.739|
91754788|NCT04051827|183402507|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.676|||||TWO_SIDED|90.0|0.532|0.859|||||The GMR of midazolam AUC∞ on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||0.859|0.532|
91754789|NCT04051827|183402508|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.3|||||TWO_SIDED|90.0|0.886|1.92|||||The GMR of midazolam Cmax on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.92|0.886|
91754790|NCT04051827|183402509|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.837|||||TWO_SIDED|90.0|0.673|1.04|||||The GMR of midazolam AUC∞ on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.04|0.673|
91754791|NCT01424566|183402517|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9173|TWO_SIDED|95.0|-0.42|0.38|||ANCOVA|||||0.38|-0.42|0.9173
91754792|NCT02690649|183402550|SUPERIORITY||estimated adherence rate for the interve|94.0||||0.28|TWO_SIDED|95.0|92.0|95.0|||Regression, Linear|||estimated adherence rate for the intervention group Generalized linear models were used to test the effect of the intervention on medication adherence. These generalized linear models used a Poisson distribution to estimate the rate of adherence with the log of total prescribed doses as an offset term in the linear predictor.||95|92|0.28
91508585|NCT02477020|182889190|SUPERIORITY_OR_OTHER||Least square mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.203||0.006|TWO_SIDED|95.0|-0.97|-0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 3||-0.17|-0.97|0.006
91532830|NCT01027871|182942393|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.518
91754793|NCT02690649|183402551|SUPERIORITY||||||<|0.001||||||A negative binomial distribution because the outcome was a count variable and it was over-dispersed.|Regression, Linear|Age, previous patient portal logins, and gender were used as co-variates in the model.||||||<0.001
91754794|NCT02690649|183402552|SUPERIORITY||Slope|-0.61||||0.03|TWO_SIDED|95.0|-1.14|-0.07||baseline AF knowledge, gender, age, and educational level were all used as co-variates.|Regression, Linear|generalized linear model tested whether AF knowledge at study completion was related to baseline AF knowledge, gender, age, and educational level||||-0.07|-1.14|0.03
91754795|NCT00110461|183402569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.99|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.5|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-3.5|-8.49|<0.0001
91754796|NCT00110461|183402569|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.77|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-5.77|-10.7|<0.0001
91754797|NCT00110461|183402570|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.89|||<|0.0001|TWO_SIDED|95.0|-8.7|-3.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.08|-8.7|<0.0001
91754798|NCT00110461|183402570|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
91754799|NCT00110461|183402571|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|95.0|5.77|12.84|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||12.84|5.77|<0.0001
91754800|NCT00110461|183402571|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
91754801|NCT00110461|183402572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.48|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.48|-1.15|<0.0001
91754802|NCT00110461|183402572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001||95.0|-1.59|-0.93|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.93|-1.59|<0.0001
91754803|NCT00110461|183402573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.0767|TWO_SIDED|95.0|-4.81|0.25|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.25|-4.81|0.0767
91754804|NCT00110461|183402573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.3515|TWO_SIDED|95.0|-3.69|1.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.32|-3.69|0.3515
91754805|NCT00110461|183402574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.73|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.73|-8.02|<0.0001
91754806|NCT00110461|183402574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.46|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.32|-7.40|<0.0001
91754807|NCT00110461|183402575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||<|0.0001|TWO_SIDED|95.0|-12.3|-5.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-5.43|-12.3|<0.0001
91754808|NCT00110461|183402575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.0001|TWO_SIDED|95.0|-11.6|-4.83|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-4.83|-11.6|<0.0001
91754809|NCT00110461|183402576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|||<|0.0001|TWO_SIDED|95.0|5.07|13.93|||t-test, 2 sided|||||13.93|5.07|<0.0001
91754810|NCT00110461|183402576|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|95.0|5.87|14.14|||t-test, 2 sided|||||14.14|5.87|<0.0001
91508586|NCT02477020|182889190|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|-0.99|-0.12||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 4||-0.12|-0.99|0.013
91508587|NCT02477020|182889190|SUPERIORITY_OR_OTHER||Least mean square difference|-0.56|STANDARD_ERROR_OF_MEAN|0.238||0.02|TWO_SIDED|95.0|-1.03|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 5||-0.09|-1.03|0.020
91508588|NCT02477020|182889190|SUPERIORITY_OR_OTHER||Least square mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.244||0.007|TWO_SIDED|95.0|-1.15|-0.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 6||-0.18|-1.15|0.007
91508589|NCT02477020|182889191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.077|TWO_SIDED|95.0|0.899|8.267||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 1||8.267|0.899|0.077
91508590|NCT02477020|182889191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.331||||0.036|TWO_SIDED|95.0|1.055|5.153||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 2||5.153|1.055|0.036
91508591|NCT02477020|182889191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.015|TWO_SIDED|95.0|1.208|5.99||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 3||5.990|1.208|0.015
91508592|NCT02477020|182889191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.737||||0.158|TWO_SIDED|95.0|0.807|3.735||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 4||3.735|0.807|0.158
91508593|NCT02477020|182889191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739||||0.164|TWO_SIDED|95.0|0.798|3.789||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 5||3.789|0.798|0.164
91532831|NCT01027871|182942394|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.938|TWO_SIDED|90.0|-0.2|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.20|0.938
91508594|NCT02477020|182889191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44||||0.003|TWO_SIDED|95.0|1.523|7.77||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 6||7.770|1.523|0.003
91508595|NCT02477020|182889192|SUPERIORITY_OR_OTHER||Least square mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.547||0.246|TWO_SIDED|95.0|-1.26|4.86||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 3||4.86|-1.26|0.246
91508596|NCT02477020|182889192|SUPERIORITY_OR_OTHER||Least square mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.767||0.216|TWO_SIDED|95.0|-1.3|5.69||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|Least square mean difference||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction|Change at Week 6||5.69|-1.30|0.216
91508597|NCT02477020|182889193|SUPERIORITY_OR_OTHER||Least mean square difference|-0.38|STANDARD_ERROR_OF_MEAN|1.664||0.82|TWO_SIDED|95.0|-3.67|2.91||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BNSS total score-by-week interaction.|Change at Week 3||2.91|-3.67|0.820
91754811|NCT00110461|183402577|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.0003|TWO_SIDED|95.0|-1.08|-0.33|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.33|-1.08|0.0003
91754812|NCT00110461|183402577|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.66|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.66|-1.41|<0.0001
91754813|NCT00110461|183402578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0878|TWO_SIDED|95.0|-0.54|0.04|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.04|-0.54|0.0878
91508598|NCT02477020|182889193|SUPERIORITY_OR_OTHER||Least square mean difference|-2.87|STANDARD_ERROR_OF_MEAN|2.05||0.163|TWO_SIDED|95.0|-6.93|1.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 6||1.18|-6.93|0.163
91508599|NCT02477020|182889194|SUPERIORITY_OR_OTHER||Least square mean difference|2.69|STANDARD_ERROR_OF_MEAN|1.769||0.131|TWO_SIDED|95.0|-0.81|6.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 3||6.19|-0.81|0.131
91532832|NCT01027871|182942394|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.0||||0.972|TWO_SIDED|90.0|-0.18|0.19||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.18|0.972
91754814|NCT00110461|183402578|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.26||||0.0752|TWO_SIDED|95.0|-0.55|0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.03|-0.55|0.0752
91754815|NCT00110461|183402579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2553|TWO_SIDED|95.0|-0.51|0.13|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.13|-0.51|0.2553
91754816|NCT00110461|183402579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0166|TWO_SIDED|95.0|-0.71|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-0.71|0.0166
91754817|NCT00110461|183402580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.51|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.51|-1.16|<0.0001
91754818|NCT00110461|183402580|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.86|-1.51|<0.0001
91754819|NCT00110461|183402581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.40|-1.13|<0.0001
91754820|NCT00110461|183402581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.6|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.60|-1.33|<0.0001
91754821|NCT00110461|183402582|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.92||||0.1729|TWO_SIDED|95.0|-4.69|0.85|||t-test, 2 sided|||||0.85|-4.69|0.1729
91754822|NCT00110461|183402582|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.43||||0.75586|TWO_SIDED|95.0|-3.17|2.31|||t-test, 2 sided|||||2.31|-3.17|0.75586
91754823|NCT00110461|183402583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.61|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.61|-6.90|<0.0001
91754824|NCT00110461|183402583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.5|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.50|-6.78|<0.0001
91754825|NCT00110461|183402584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.0468|TWO_SIDED|95.0|-3.67|-0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.03|-3.67|0.0468
91754826|NCT00110461|183402584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.0296|TWO_SIDED|95.0|-3.85|-0.2|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.20|-3.85|0.0296
91754827|NCT00110461|183402585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.1309|TWO_SIDED|95.0|-3.31|0.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.43|-3.31|0.1309
91532833|NCT01027871|182942394|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.927|TWO_SIDED|90.0|-0.16|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.16|0.927
91508600|NCT02477020|182889194|SUPERIORITY_OR_OTHER||Least square mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.313||0.26|TWO_SIDED|95.0|-1.96|7.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 6||7.19|-1.96|0.260
91508601|NCT02477020|182889195|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.855||0.973|TWO_SIDED|95.0|-3.61|3.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 3||3.73|-3.61|0.973
91532834|NCT01027871|182942394|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.1||||0.293|TWO_SIDED|90.0|-0.25|0.05||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.25|0.293
91532835|NCT05489224|182942404|EQUIVALENCE|Predefined margin: -0.6 to 0.5|Treatment difference and 90% CI|-0.1|||||TWO_SIDED|90.0|-0.3|0.1|||ANCOVA|ANCOVA with multiple imputation||||0.10|-0.30|
91532836|NCT04640571|182942427|EQUIVALENCE|Simple one-way t-test to assess if pravastatin AUC value is larger after metformin than after placebo.||||||0.02|||||||t-test, 1 sided|||||||0.02
91532837|NCT04640571|182942428|EQUIVALENCE|Simple one-way t-test to assess if pravastatin Cmax value is larger after metformin than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532838|NCT04640571|182942429|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532839|NCT04640571|182942430|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91508602|NCT02477020|182889195|SUPERIORITY_OR_OTHER||Least mean square difference|-0.54|STANDARD_ERROR_OF_MEAN|2.255||0.812|TWO_SIDED|95.0|-5.0|3.92||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 6||3.92|-5.00|0.812
91532840|NCT04640571|182942431|EQUIVALENCE|Simple one-way t-test to assess if acyclovir AUC value is reduced after polysorbate 80 than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532841|NCT04640571|182942432|EQUIVALENCE|Simple one-way t-test to assess if acyclovir Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532842|NCT04640571|182942433|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91508603|NCT01049919|182889205|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.224|TWO_SIDED|95.0|0.31|1.31|||Proportional Hazards Regression|||||1.31|0.31|0.224
91532843|NCT04640571|182942434|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532844|NCT04640571|182942435|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat AUC value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532845|NCT04640571|182942436|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat Cmax value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91508604|NCT01049919|182889206|SUPERIORITY|||||||0.671||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.671
91532846|NCT04640571|182942437|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532847|NCT04640571|182942438|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532848|NCT04640571|182942439|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532849|NCT04640571|182942440|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91532850|NCT04060680|182942487|SUPERIORITY|The pre-specified Objective Performance Criterion (OPC) for the major complication free rate at 6 months is 0.79. If the lower confidence bound of two-sided 95% confidence interval for the freedom from the first major EV ICD System/procedure-related complication through 182 days post implant exceeds 0.79, the primary safety objective will be met. The freedom from the first major EV ICD System/procedure-related complication was estimated using the Kaplan-Meier method.|Major complication-free rate|92.6|||<|0.0001|TWO_SIDED|95.0|89.0|95.0||A priori threshold for statistical significance is 0.025|Kaplan-Meier method|||The primary safety objective is to demonstrate the freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant exceeds an OPC of 79%. H0: p ≤ 0.79 HA: p \> 0.79, where p denotes the 6-month (182 days) freedom from major EV ICD System/procedure-related complications rate.||95.0|89.0|<0.0001
91508605|NCT01049919|182889207|SUPERIORITY|||||||0.714||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.714
91508606|NCT01049919|182889209|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.018|TWO_SIDED|95.0|0.16|0.85|||Proportional Hazards Regression|||||0.85|0.16|0.018
91508607|NCT00812929|182889213|SUPERIORITY||Mean Difference (Net)|1.29|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-1.56|4.13||||||||4.13|-1.56|
91508608|NCT00812929|182889213|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-2.32|3.37||||||||3.37|-2.32|
91508609|NCT00812929|182889213|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.441|||TWO_SIDED|95.0|-2.52|3.18||||||||3.18|-2.52|
91508610|NCT00812929|182889213|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|1.438|||TWO_SIDED|95.0|-0.31|5.37||||||||5.37|-0.31|
91508611|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.638|||TWO_SIDED|95.0|-0.72|5.75||||||2 Hours||5.75|-0.72|
91508612|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-2.34|2.58||||||9.5 Hours||2.58|-2.34|
91508613|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|-0.64|5.84||||||2 Hours||5.84|-0.64|
91532851|NCT04060680|182942488|SUPERIORITY|The pre-specified OPC for the EV ICD defibrillation testing success at implant is 0.88. If the lower confidence bound of two-sided 95% confidence interval for the proportion of EV ICD patients achieving defibrillation testing success at implant exceeds 0.88, the primary efficacy objective will be met. The primary efficacy objective will be evaluated using a one-proportion binomial exact test along with a two-sided 95% Clopper-Pearson confidence bound.|Proportion|98.7|||<|0.0001|TWO_SIDED|95.0|96.6|99.6||A priori threshold for statistical significance is 0.025|One-proportion binomial exact test|||The primary efficacy is to demonstrate the EV ICD defibrillation testing success rate at implant is greater than an OPC of 88%. H0: p ≤ 0.88 HA: p \> 0.88, where p denotes the probability of EV ICD defibrillation success at implant.||99.6|96.6|<0.0001
91532852|NCT02320721|182942499|NON_INFERIORITY|Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.092|0.129||||||Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.||0.129|-0.092|
91759707|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.29|||||TWO_SIDED|95.0|-28.22|9.62|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||9.62|-28.22|
91759708|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
91759709|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
91759710|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-23.42|||||TWO_SIDED|95.0|-42.26|-4.59|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-4.59|-42.26|
91508614|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-1.7|3.22||||||9.5 Hours||3.22|-1.70|
91508615|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|1.639|||TWO_SIDED|95.0|-0.45|6.03||||||2 Hours||6.03|-0.45|
91508616|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|3.49|STANDARD_ERROR_OF_MEAN|1.248|||TWO_SIDED|95.0|1.02|5.95||||||9.5 Hours||5.95|1.02|
91508617|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|3.06|9.54||||||2 Hours||9.54|3.06|
91508618|NCT00812929|182889214|SUPERIORITY||Mean Difference (Net)|2.27|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-0.19|4.73||||||9.5 Hours||4.73|-0.19|
91508619|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-1.37|3.25|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.25|-1.37|
91508620|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-1.66|1.8|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||1.80|-1.66|
91508621|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.82|2.63|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||2.63|-0.82|
91508622|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-1.19|3.43|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.43|-1.19|
91508623|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-0.51|2.95|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||2.95|-0.51|
91508624|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-1.55|1.9|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.90|-1.55|
91508625|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|1.51|STANDARD_ERROR_OF_MEAN|1.171|||TWO_SIDED|95.0|-0.8|3.82|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.82|-0.80|
91508626|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|0.879|||TWO_SIDED|95.0|1.57|5.03|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||5.03|1.57|
91508627|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.874|||TWO_SIDED|95.0|-1.83|1.62|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.62|-1.83|
91508628|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|3.17|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|0.86|5.48|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||5.48|0.86|
91508629|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|0.877|||TWO_SIDED|95.0|0.38|3.84|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||3.84|0.38|
91532853|NCT02320721|182942500|SUPERIORITY_OR_OTHER_LEGACY|A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.|Relative risk|1.01||||0.8415|TWO_SIDED|95.0|0.89|1.153||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c \[\<8.0%; ≥8.0%\], previous use of insulin \[naive, pre-treated\], use of sulfonylurea or meglitinides at screening \[yes, no\]), following multiple imputation procedure for missing data.||1.153|0.890|0.8415
91508630|NCT00812929|182889215|SUPERIORITY||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.0|3.44|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||3.44|-0.00|
91508631|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.71|2.21|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.21|0.71|
91508632|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.59|2.06|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||2.06|0.59|
91508633|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.78|||||TWO_SIDED|95.0|0.93|3.43|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.43|0.93|
91532854|NCT03173248|182942511|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0011|TWO_SIDED|95.0|0.16|0.69||P-value is calculated from the one-sided log-rank test stratified by the randomization stratification factors (AML status and geographic region).|Log Rank||Hazard ratio is estimated using a Cox's proportional hazards model stratified by the randomization stratification factors (AML status and geographic region) with placebo + azacitidine as the denominator.|||0.69|0.16|0.0011
91532855|NCT00929305|182942577|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91754828|NCT00110461|183402585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.0058|TWO_SIDED|95.0|-4.51|-0.77|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.77|-4.51|0.0058
91532856|NCT00929305|182942580|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
91532857|NCT00231179|182942599|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|15.0||0.59|TWO_SIDED|95.0|0.31|2.13||Bonferroni corrections were made for multiple comparisons.|t-test, 2 sided|||We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).||2.13|0.31|0.59
91508634|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.81|2.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.48|0.81|
91532858|NCT00231179|182942600|NON_INFERIORITY_OR_EQUIVALENCE|Please see earlier power calculation.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0||0.72|TWO_SIDED|95.0|||||Chi-squared|||||||0.72
91532859|NCT00231179|182942601|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0|<|0.01|TWO_SIDED|95.0|||||Chi-squared|||||||<0.01
91532860|NCT00231179|182942602|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
91754829|NCT00110461|183402586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.043|TWO_SIDED|95.0|-4.2|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-4.20|0.0430
91759711|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-13.73|||||TWO_SIDED|95.0|-33.35|5.87|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||5.87|-33.35|
91508635|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.93|||||TWO_SIDED|95.0|1.01|3.66|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.66|1.01|
91508636|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.86|3.25|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.25|0.86|
91508637|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|1.19|3.69|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||3.69|1.19|
91508638|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|5.49|||||TWO_SIDED|95.0|2.75|10.94|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||10.94|2.75|
91508639|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|1.0|3.64|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.64|1.00|
91508640|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|3.6|||||TWO_SIDED|95.0|2.0|6.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||6.48|2.00|
91508641|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|2.03|||||TWO_SIDED|95.0|1.07|3.87|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.87|1.07|
91508642|NCT00812929|182889216|SUPERIORITY||Hazard Ratio (HR)|6.07|||||TWO_SIDED|95.0|2.9|12.71|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||12.71|2.90|
91508643|NCT02975934|182889235|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.69|||Log Rank|||||0.69|0.36|<0.001
91508644|NCT02975934|182889236|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.80|0.47|<0.001
91508645|NCT02975934|182889237|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5044|TWO_SIDED|95.0|0.68|1.2|||Log Rank|||||1.20|0.68|0.5044
91508646|NCT02975934|182889238|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9368|TWO_SIDED|95.0|0.78|1.26|||Log Rank|||||1.26|0.78|0.9368
91532861|NCT00231179|182942603|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.64|TWO_SIDED|95.0|||||Chi-squared|||||||0.64
91532862|NCT04672460|182942614|OTHER||Ratio (Test/Reference) of Adjusted Means|105.16|||||TWO_SIDED|90.0|99.0|111.7|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||111.70|99.00|
91754830|NCT00110461|183402586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.7696|TWO_SIDED|95.0|-2.37|1.76|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.76|-2.37|0.7696
91754831|NCT00110461|183402587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
91754832|NCT00110461|183402587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.19|TWO_SIDED|95.0|-1.67|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.67|0.19
91532863|NCT04672460|182942615|OTHER||Ratio (Test/Reference) of Adjusted Means|136.62|||||TWO_SIDED|90.0|125.05|149.27|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||149.27|125.05|
91754833|NCT00110461|183402588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
91759712|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.23|||||TWO_SIDED|95.0|-17.26|23.74|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||23.74|-17.26|
91759713|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-3.09|||||TWO_SIDED|95.0|-23.27|17.07|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||17.07|-23.27|
91759714|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.13|||||TWO_SIDED|95.0|-22.77|10.5|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||10.50|-22.77|
91759715|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.63|||||TWO_SIDED|95.0|-19.63|14.35|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||14.35|-19.63|
91759716|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.53|||||TWO_SIDED|95.0|-17.06|18.12|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||18.12|-17.06|
91759717|NCT01393639|183411978|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.89|||||TWO_SIDED|95.0|-23.24|9.46|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.46|-23.24|
91759718|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||0.00|0.00|
91759719|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.34|||||TWO_SIDED|95.0|-1.54|10.24|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||10.24|-1.54|
91759720|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
91759721|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.38|||||TWO_SIDED|95.0|-0.6|13.37|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.37|-0.60|
91759722|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
91759723|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.69|||||TWO_SIDED|95.0|0.55|16.83|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||16.83|0.55|
91759724|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||0.00|0.00|
91759725|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.51|||||TWO_SIDED|95.0|0.53|16.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||16.48|0.53|
91759726|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|4.96|26.14|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||26.14|4.96|
91759727|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.02|||||TWO_SIDED|95.0|6.27|27.76|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.76|6.27|
91759728|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-1.57|10.46|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.46|-1.57|
91759729|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.21|||||TWO_SIDED|95.0|4.83|25.59|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||25.59|4.83|
91759730|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-9.62|5.18|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||5.18|-9.62|
91532864|NCT04672460|182942616|OTHER||Ratio (Test/Reference) of Adjusted Means|87.97|||||TWO_SIDED|90.0|81.82|94.58|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||94.58|81.82|
91754834|NCT00110461|183402588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.8377|TWO_SIDED|95.0|-1.61|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.61|0.8377
91508647|NCT02075840|182889255|SUPERIORITY||Hazard Ratio, stratified|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.65|||Log Rank|||Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||0.65|0.34|<0.0001
91508648|NCT02075840|182889257|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||||0.70|0.36|<0.0001
91508649|NCT02075840|182889259|SUPERIORITY|IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)|Cause-Specific Hazard Ratio|0.16|||<|0.0001|TWO_SIDED|95.0|0.1|0.28|||Log Rank|||||0.28|0.10|<0.0001
91508650|NCT02075840|182889261|SUPERIORITY||Difference in Overall Response Rates|7.4||||0.0936|TWO_SIDED|95.0|-1.71|16.5||Stratified analysis|Mantel Haenszel|||||16.50|-1.71|0.0936
91508651|NCT02075840|182889263|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2405|TWO_SIDED|95.0|0.48|1.2||Stratified analysis|Log Rank|||||1.20|0.48|0.2405
91508652|NCT02075840|182889274|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2079|TWO_SIDED|95.0|0.46|1.19|||Log Rank|Stratified analysis||Fatigue||1.19|0.46|0.2079
91508653|NCT02075840|182889274|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.1137|TWO_SIDED|95.0|0.88|3.15||Stratified analysis|Log Rank|||Dyspnea||3.15|0.88|0.1137
91508654|NCT02075840|182889276|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.7042|TWO_SIDED|95.0|0.44|1.74||Stratified analysis|Log Rank|||Coughing||1.74|0.44|0.7042
91508655|NCT02075840|182889276|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0285|TWO_SIDED|95.0|1.05|2.92||Stratified analysis|Log Rank|||Dyspnea||2.92|1.05|0.0285
91508656|NCT02075840|182889276|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.2377|TWO_SIDED|95.0|0.79|2.61||Stratified analysis|Log Rank|||Pain in arm and shoulder||2.61|0.79|0.2377
91508657|NCT02075840|182889276|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0796|TWO_SIDED|95.0|0.24|1.1||Stratified analysis|Log Rank|||Pain in chest||1.10|0.24|0.0796
91508658|NCT02075840|182889276|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6435|TWO_SIDED|95.0|0.72|1.68||Stratified analysis|Log Rank|||Composite score||1.68|0.72|0.6435
91508659|NCT05429203|182889283|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.8
91508660|NCT05429203|182889284|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1
91508661|NCT05429203|182889285|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
91532865|NCT04672460|182942617|OTHER||Ratio (Test/Reference) of Adjusted Means|58.26|||||TWO_SIDED|90.0|51.55|65.84|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||65.84|51.55|
91532866|NCT03575962|182942625|OTHER||Ratio of geometric least square mean|1.1169|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
91532867|NCT03575962|182942626|OTHER||Ratio of geometric least square mean|1.1556|||||TWO_SIDED|90.0|0.99|1.35||||||||1.35|0.99|
91532868|NCT02949271|182942674|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91508662|NCT05429203|182889286|OTHER|||||||0.4||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.4
91532869|NCT02949271|182942675|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91754835|NCT00110461|183402589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.3969|TWO_SIDED|95.0|-2.71|1.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.08|-2.71|0.3969
91754836|NCT00110461|183402589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.2101|TWO_SIDED|95.0|-3.09|0.68|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.68|-3.09|0.2101
91754837|NCT00110461|183402590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.0001|TWO_SIDED|95.0|-10.5|-3.64|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.64|-10.5|<0.0001
91754838|NCT00110461|183402590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0014|TWO_SIDED|95.0|-8.94|-2.16|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.16|-8.94|0.0014
91754839|NCT00110461|183402591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7||||0.0074|TWO_SIDED|95.0|5.01|32.4|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||32.40|5.01|0.0074
91754840|NCT00110461|183402591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.55|||<|0.0001|TWO_SIDED|95.0|23.41|51.68|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||51.68|23.41|<0.0001
91754841|NCT00110461|183402592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.0009|TWO_SIDED|95.0|9.57|37.24|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||37.24|9.57|0.0009
91754842|NCT00110461|183402592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.96|||<|0.0001|TWO_SIDED|95.0|15.05|42.87|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||42.87|15.05|<0.0001
91508663|NCT05429203|182889287|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
91508664|NCT05429203|182889288|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
91508665|NCT05429203|182889289|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
91532870|NCT02949271|182942677|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91754843|NCT00110461|183402593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.66|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.66|-1.29|<0.0001
91754844|NCT00110461|183402593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.7|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.70|-1.39|<0.0001
91754845|NCT00110461|183402594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.002|TWO_SIDED|95.0|-1.04|-0.24|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.24|-1.04|0.0020
91508666|NCT05429203|182889290|OTHER|||||||0.6||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.6
91508667|NCT05429203|182889291|OTHER|||||||0.5||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.5
91508668|NCT05429203|182889292|OTHER|||||||0.9||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
91508669|NCT05429203|182889293|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
91508670|NCT05429203|182889294|OTHER|||||||0.9||||||the a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
91532871|NCT02949271|182942678|OTHER|||||||0.28|||||||Chi-squared|||||||0.28
91532872|NCT02949271|182942679|OTHER|||||||0.85|||||||Chi-squared|||||||0.85
91532873|NCT02949271|182942680|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91532874|NCT02949271|182942681|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91532875|NCT02949271|182942682|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
91754846|NCT00110461|183402594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0001|TWO_SIDED|95.0|-1.19|-0.41|||Cochran-Mantel-Haenszel|||||-0.41|-1.19|0.0001
91754847|NCT00110461|183402595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.96|-0.26|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.26|-0.96|0.0010
91754848|NCT00110461|183402595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0053|TWO_SIDED|95.0|-0.85|-0.16|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.16|-0.85|0.0053
91754849|NCT00110461|183402596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.1726|TWO_SIDED|95.0|-0.64|0.11|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||0.11|-0.64|0.1726
91754850|NCT00110461|183402596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0113|TWO_SIDED|95.0|-0.89|-0.12|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.12|-0.89|0.0113
91532876|NCT02949271|182942684|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
91532877|NCT05458102|182942685|OTHER||Geometric Least-squares Mean Ratio|560.0|||||TWO_SIDED|90.0|414.0|757.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||757|414|
91754851|NCT00110461|183402597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.67|-1.31|<0.0001
91508671|NCT02402452|182889298|OTHER||Geometric Least-Square Mean(GLSM)Ratio %|172.92|||||TWO_SIDED|90.0|97.93|305.33||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||305.33|97.93|
91508672|NCT02402452|182889299|OTHER||GLSM Ratio (%)|171.27|||||TWO_SIDED|90.0|97.65|300.38||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||300.38|97.65|
91754852|NCT00110461|183402597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.72|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.72|-1.39|<0.0001
91508673|NCT02402452|182889300|OTHER||GLSM Ratio (%)|145.43|||||TWO_SIDED|90.0|83.77|252.48||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of Cmax for the comparison groups using two 1-sided tests.||252.48|83.77|
91508674|NCT02644967|182889302|OTHER|Estimation||||||0.0158||||||P-value of the overall response tested against the null rate of 11% based on 1-sided exact (Clopper-Pearson) test.|One-sided Clopper-Pearson test|||Testing the best overall confirmed response rate against the historical control rate of 0.11 (extracted from the literature review).||||0.0158
91532878|NCT05458102|182942685|OTHER||Geometric Least-squares Mean Ratio|137.0|||||TWO_SIDED|90.0|99.5|189.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||189|99.5|
91532879|NCT05458102|182942686|OTHER||Geometric Least-squares Mean Ratio|433.0|||||TWO_SIDED|90.0|347.0|540.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||540|347|
91532880|NCT05458102|182942686|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|93.5|150.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||150|93.5|
91754853|NCT00110461|183402598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.003|TWO_SIDED|95.0|-1.04|-0.22|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.22|-1.04|0.0030
91508675|NCT02644967|182889303|OTHER|Estimation|Kaplan-Meier|5.06|||||TWO_SIDED|95.0|3.65|7.0|||||Kaplan-Meier estimate of median PFS in months.|||7.00|3.65|
91508676|NCT02644967|182889304|OTHER|Landmark analysis of overall survival at six (6) months.|Kaplan-Meier|87.5|||||TWO_SIDED|95.0|74.3|94.2|||||Kaplan-Meier estimate of percentage of participants surviving at six (6) months.|||94.2|74.3|
91508677|NCT02644967|182889305|OTHER|Landmark analysis of overall survival at twelve (12) months.|Kaplan-Meier|60.0|||||TWO_SIDED|95.0|44.7|72.4|||||Kaplan-Meier estimate of percentage of participants surviving at twelve (12) months.|||72.4|44.7|
91754854|NCT00110461|183402598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0001|TWO_SIDED|95.0|-1.18|-0.4|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.40|-1.18|0.0001
91754855|NCT00316888|183402599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218|||||||one sample binomial test|||Null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.218
91754856|NCT00316888|183402599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592|||||||one sample binomial test|||The null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.592
91754857|NCT02715726|183402611|SUPERIORITY||LS mean difference|-35.6|||<|0.0001|TWO_SIDED|95.0|-40.6|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-30.7|-40.6|<0.0001
91754858|NCT02715726|183402612|SUPERIORITY||LS mean difference|-37.3|||<|0.0001|TWO_SIDED|95.0|-42.1|-32.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-32.6|-42.1|<0.0001
91754859|NCT02715726|183402613|SUPERIORITY||LS mean difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-39.5|-30.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.2|-39.5|<0.0001
91754860|NCT02715726|183402614|SUPERIORITY||LS mean difference|-35.4|||<|0.0001|TWO_SIDED|95.0|-40.0|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.7|-40.0|<0.0001
91754861|NCT02715726|183402615|SUPERIORITY|Threshold for significance at 0.05 level.|LS mean difference|-27.4|||<|0.0001|TWO_SIDED|95.0|-30.8|-23.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.9|-30.8|<0.0001
91754862|NCT02715726|183402616|SUPERIORITY||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.4|-31.2|<0.0001
91508678|NCT05179421|182889313|OTHER|NONMEM applies nonlinear mixed effects modeling to evaluate the relationship between predicted drug concentration after administration from known pharmacokinetics and a pharmacodynamic effect, in this case being a reduction in pain from sustained heat application.|||||<|0.05|||||||Mixed Models Analysis|||Pain scores over time will first be modeled using NONMEM with derived parameters of maximum effect (Emax) and doses to produce a 50% and 90% maximum drug effect (C50 and C90, respectively), the steepness of the dose response curve (γ), and the time to peak effect. Inter-subject variability (e.g., biological variability) will evaluate additive, proportional, and exponential models. Residual intrasubject variability (e.g., noise) will typically require an additive and multiplicative error model.||||<0.05
91508679|NCT01077960|182889314|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91508680|NCT01077960|182889315|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91508681|NCT01077960|182889316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91508682|NCT01077960|182889317|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91508683|NCT01077960|182889318|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
91754863|NCT02715726|183402617|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-31.8|-23.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.6|-31.8|<0.0001
91508684|NCT01077960|182889319|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
91508685|NCT01702233|182889320|NON_INFERIORITY_OR_EQUIVALENCE|All statistical analyses were of exploratory nature. A one-sided test of non-inferiority of Traumeel®S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval . The non-inferiority margin was set to 13 mm on a 0-100 mm VAS scale.|Mean Difference (Final Values)|13.0|STANDARD_DEVIATION|13.0|<|0.05|ONE_SIDED|95.0||97.5|||ANCOVA|||||97.5||<0.05
91508686|NCT02800148|182889427|EQUIVALENCE|provides 85% power of success|equivalence ratio|107.0|||||TWO_SIDED|90.0|96.1|115.5||No p-value as calculated for bioequivalence, just a T/R ratio and 90% confidence interval|Fieller's method|||||115.5|96.1|
91508687|NCT00613509|182889434|SUPERIORITY_OR_OTHER|||||||0.9406|TWO_SIDED|95.0|||||Log Rank|||||||0.9406
91508688|NCT00613509|182889434|SUPERIORITY_OR_OTHER|||||||0.9179|TWO_SIDED|95.0|||||Likelihood ratio test|||||||0.9179
91508689|NCT03465878|182889437|SUPERIORITY||Ratio of geometric least squares means|0.999||||0.9813|TWO_SIDED|95.0|0.918|1.09|||Mixed Models Analysis|||||1.09|0.918|0.9813
91754864|NCT02715726|183402618|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-32.6|-24.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.7|-32.6|<0.0001
91754865|NCT02715726|183402619|SUPERIORITY||LS mean difference|-20.2|||<|0.0001|TWO_SIDED|95.0|-23.1|-17.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.2|-23.1|<0.0001
91508690|NCT03465878|182889437|SUPERIORITY||Ratio of geometric least squares means|1.06||||0.1638|TWO_SIDED|95.0|0.976|1.15|||Mixed Models Analysis|||||1.15|0.976|0.1638
91508691|NCT03465878|182889437|SUPERIORITY||Ratio of geometric least squares means|1.01||||0.7623|TWO_SIDED|95.0|0.933|1.1|||Mixed Models Analysis|||||1.10|0.933|0.7623
91508692|NCT03465878|182889437|SUPERIORITY||Ratio of geometric least squares means|1.04||||0.2952|TWO_SIDED|95.0|0.962|1.13|||Mixed Models Analysis|||||1.13|0.962|0.2952
91754866|NCT02715726|183402620|SUPERIORITY||LS mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-29.8|-23.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.2|-29.8|<0.0001
91508693|NCT03465878|182889437|SUPERIORITY||Ratio of geometric least squares means|0.97||||0.4052|TWO_SIDED|95.0|0.901|1.04|||Mixed Models Analysis|||||1.04|0.901|0.4052
91532881|NCT05458102|182942687|OTHER||Geometric Least-squares Mean Ratio|752.0|||||TWO_SIDED|90.0|525.0|1080.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||1080|525|
91759731|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.32|||||TWO_SIDED|95.0|-2.96|19.6|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||19.60|-2.96|
91508694|NCT03465878|182889437|SUPERIORITY||Ratio of geometric least squares means|1.02||||0.5314|TWO_SIDED|95.0|0.948|1.11|||Mixed Models Analysis|||||1.11|0.948|0.5314
91508695|NCT02540954|182889439|NON_INFERIORITY|Non-inferiority margin is 5 letters.|Least squares mean difference|0.22|||<|0.0001|TWO_SIDED|95.0|-1.51|1.96|||ANCOVA|||||1.96|-1.51|< 0.0001
91508696|NCT02540954|182889440|NON_INFERIORITY|Non inferiority margin is 7%.|Treatment difference in %|1.1|||||TWO_SIDED|95.0|-3.7|6.0||||||||6.0|-3.7|
91508697|NCT02540954|182889445|OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-4.152|0.392||||||||0.392|-4.152|
91508698|NCT01806896|182889461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.68||0.68|TWO_SIDED|90.0|-3.56|2.15||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effects and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Day 28)||2.15|-3.56|0.68
91508699|NCT01806896|182889463|SUPERIORITY_OR_OTHER||Least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.79|TWO_SIDED|90.0|-0.72|0.52||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Left VS)||0.52|-0.72|0.79
91508700|NCT01806896|182889463|SUPERIORITY_OR_OTHER||Least square mean|-0.15|STANDARD_ERROR_OF_MEAN|0.37||0.7|TWO_SIDED|90.0|-0.8|0.51||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Right VS)||0.51|-0.80|0.70
91508701|NCT01806896|182889463|SUPERIORITY_OR_OTHER||Least square mean|-0.25|STANDARD_ERROR_OF_MEAN|0.37||0.51|TWO_SIDED|90.0|-0.89|0.4||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Left VS)||0.40|-0.89|0.51
91508702|NCT01806896|182889463|SUPERIORITY_OR_OTHER||Least square mean|-0.53|STANDARD_ERROR_OF_MEAN|0.33||0.13|TWO_SIDED|90.0|-1.1|0.04||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Right VS)||0.04|-1.10|0.13
91508703|NCT01806896|182889466|SUPERIORITY_OR_OTHER||Least square mean|7.3|STANDARD_ERROR_OF_MEAN|3.57||0.04|TWO_SIDED|90.0|1.43|13.18||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Neutral) Day 28||13.18|1.43|0.04
91508704|NCT01806896|182889466|SUPERIORITY_OR_OTHER||Least square mean|7.57|STANDARD_ERROR_OF_MEAN|3.57||0.03|TWO_SIDED|90.0|1.69|13.45||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28||13.45|1.69|0.03
91754867|NCT02715726|183402621|SUPERIORITY||LS mean difference|-26.7|||<|0.0001|TWO_SIDED|95.0|-30.5|-22.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.8|-30.5|<0.0001
91754868|NCT02715726|183402622|SUPERIORITY||LS mean difference|-19.3|||<|0.0001|TWO_SIDED|95.0|-22.1|-16.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-16.5|-22.1|<0.0001
91754869|NCT02715726|183402623|SUPERIORITY||Odds Ratio (OR)|11.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||17.7|7.1|<0.0001
91754870|NCT02715726|183402624|SUPERIORITY||Odds Ratio (OR)|13.6|||<|0.0001|TWO_SIDED|95.0|8.3|22.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.3|8.3|<0.0001
91754871|NCT02715726|183402625|SUPERIORITY||Adjusted Mean Difference|-34.273|||<|0.0001|TWO_SIDED|95.0|-39.262|-29.285||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.285|-39.262|<0.0001
91754872|NCT02715726|183402626|SUPERIORITY||LS mean difference|1.9||||0.228|TWO_SIDED|95.0|-1.2|4.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.9|-1.2|0.2280
91754873|NCT02636946|183402699|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0166|TWO_SIDED|95.0|-1.28|-0.13|||MMRM|||Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||-0.13|-1.28|0.0166
91754874|NCT02636946|183402700|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.29||0.0735|TWO_SIDED|95.0|-1.09|0.05|||MMRM|||Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.05|-1.09|0.0735
91754875|NCT02636946|183402701|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3928|TWO_SIDED|95.0|-0.81|0.32|||MMRM|||Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.32|-0.81|0.3928
91754876|NCT01541917|183402715|SUPERIORITY_OR_OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.06|-0.02|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since group procedures were initiated.|Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable||-.02|-.06|<.001
91759732|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-2.72|20.5|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||20.50|-2.72|
91759733|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.57|||||TWO_SIDED|95.0|0.26|24.89|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||24.89|0.26|
91508705|NCT01806896|182889466|SUPERIORITY_OR_OTHER||Least square mean|7.28|STANDARD_ERROR_OF_MEAN|3.56||0.04|TWO_SIDED|90.0|1.41|13.15||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28||13.15|1.41|0.04
91508706|NCT01806896|182889466|SUPERIORITY_OR_OTHER||Least square mean|0.98|STANDARD_ERROR_OF_MEAN|3.58||0.78|TWO_SIDED|90.0|-4.91|6.87||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28||6.87|-4.91|0.78
91508707|NCT01806896|182889466|SUPERIORITY_OR_OTHER||Least square mean|4.78|STANDARD_ERROR_OF_MEAN|3.58||0.18|TWO_SIDED|90.0|-1.11|10.67||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28||10.67|-1.11|0.18
91508708|NCT01806896|182889466|SUPERIORITY_OR_OTHER||Least square mean|16.35|STANDARD_ERROR_OF_MEAN|3.58|<|0.01|TWO_SIDED|90.0|10.46|22.24||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28||22.24|10.46|<0.01
91508709|NCT02434770|182889474|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.84|||||TWO_SIDED|95.0|0.65|1.08|||||Lot 1 / Lot 2|||1.08|0.65|
91508710|NCT02434770|182889474|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.08|||||TWO_SIDED|95.0|0.87|1.34|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.34|0.87|
91508711|NCT02434770|182889475|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.92|||||TWO_SIDED|95.0|0.73|1.15|||||Lot 1 / Lot 2|||1.15|0.73|
91508712|NCT02434770|182889475|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.47|||||TWO_SIDED|95.0|1.21|1.79|||||BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV|||1.79|1.21|
91532882|NCT05458102|182942687|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|80.3|172.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||172|80.3|
91508713|NCT02434770|182889476|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|1.5|||||TWO_SIDED|95.0|-0.5|4.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For serotype 1||4.6|-0.5|
91508714|NCT02434770|182889476|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|2.2|||||TWO_SIDED|95.0|-0.1|5.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For Serotype 3||5.6|-0.1|
91508715|NCT02434770|182889476|OTHER|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|-0.4|||||TWO_SIDED|95.0|-3.0|2.1|||||Lot 1 - Lot 2|For Serotype 1||2.1|-3.0|
91508716|NCT02434770|182889476|NON_INFERIORITY|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|0.1|||||TWO_SIDED|95.0|-2.6|2.8|||||Lot 1 - Lot 2|For Serotype 3||2.8|-2.6|
91532883|NCT05458102|182942689|OTHER||Geometric Least-squares Mean Ratio|68.5|||||TWO_SIDED|90.0|45.5|103.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||103|45.5|
91532884|NCT05458102|182942689|OTHER||Geometric Least-squares Mean Ratio|65.4|||||TWO_SIDED|90.0|42.5|101.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||101|42.5|
91532885|NCT05458102|182942693|OTHER||Geometric Least-squares Mean Ratio|120.0|||||TWO_SIDED|90.0|104.0|138.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||138|104|
91508717|NCT02434770|182889477|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|1.2|||||TWO_SIDED|95.0|0.89|1.63|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.63|0.89|
91508718|NCT02434770|182889478|OTHER||Difference in seroprotection rate|-0.09||||0.5586|TWO_SIDED|95.0|-3.86|4.48|||Fisher's exact 1-tailed test|Fisher's exact 1-tailed test of a lower rate in Lots 1+2|BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|||4.48|-3.86|0.5586
91508719|NCT02434770|182889479|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|0.99|||||TWO_SIDED|95.0|0.71|1.38|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.38|0.71|
91508720|NCT01282424|182889484|SUPERIORITY||||||<|0.0001||||||The null hypothesis is ≤ 20%.|Exact binomial test|||||||< 0.0001
91754877|NCT01541917|183402715|SUPERIORITY_OR_OTHER||Slope|-0.014|STANDARD_ERROR_OF_MEAN|0.021||0.51|TWO_SIDED|95.0|-0.055|0.027|||Multilevel growth model||The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.027|-.055|.51
91754878|NCT01541917|183402716|SUPERIORITY_OR_OTHER||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.27|0.46|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.46|.27|<.001
91754879|NCT01541917|183402716|SUPERIORITY_OR_OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.101||0.59|TWO_SIDED|95.0|-0.144|0.252|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.252|-.144|.59
91754880|NCT01541917|183402717|SUPERIORITY_OR_OTHER||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.1|0.14|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.14|.10|<.001
91754881|NCT01541917|183402717|SUPERIORITY_OR_OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.63|TWO_SIDED|95.0|-0.05|0.03|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.03|-.05|.63
91754882|NCT01541917|183402718|SUPERIORITY_OR_OTHER||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|95.0|-0.18|-0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||-.01|-.18|.02
91754883|NCT01541917|183402718|SUPERIORITY_OR_OTHER||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.084||0.91|TWO_SIDED|95.0|-0.174|0.155|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.155|-.174|.91
91508721|NCT04074317|182889502|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001||||||Least-squares geometric means for ln-transformed data.|ANOVA|||||||<0.0001
91508722|NCT04074317|182889502|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.||||||0.694|||||||ANOVA|||||||0.694
91508723|NCT04074317|182889502|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001|||||||ANOVA|||||||<0.0001
91532886|NCT05458102|182942693|OTHER||Geometric Least-squares Mean Ratio|111.0|||||TWO_SIDED|90.0|95.4|128.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||128|95.4|
91532887|NCT05642000|182942698|SUPERIORITY||Odds Ratio, log|0.187|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|-0.079|0.454|||Mixed Models Analysis|||||0.454|-0.079|
91532888|NCT01764386|182942723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.52|||<|0.0001|TWO_SIDED|95.0|-9.88|-7.15|||ANCOVA|||||-7.15|-9.88|<0.0001
91532889|NCT01764386|182942724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||<|0.0001|TWO_SIDED|95.0|16.6|116.3|||Regression, Logistic|||||116.3|16.6|<0.0001
91532890|NCT01764386|182942725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.4|||<|0.0001|TWO_SIDED|95.0|6.0|76.7|||Regression, Logistic|||||76.7|6.0|<0.0001
91754884|NCT01541917|183402719|SUPERIORITY_OR_OTHER||Slope|0.0316|STANDARD_ERROR_OF_MEAN|0.004|<|0.001|TWO_SIDED|95.0|0.02|0.04|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.04|.02|<.001
91759734|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-7.23|11.67|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||11.67|-7.23|
91759735|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.29|||||TWO_SIDED|95.0|3.94|30.64|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||30.64|3.94|
91508724|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-21.29||||0.041|TWO_SIDED|95.0|-41.23|-1.36|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||-1.36|-41.23|0.041
91508725|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-7.45||||0.453|TWO_SIDED|95.0|-31.43|16.54|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||16.54|-31.43|0.453
91508726|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|13.85||||0.161|TWO_SIDED|95.0|-8.46|36.15|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||36.15|-8.46|0.161
91508727|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-23.93|||<|0.001|TWO_SIDED|95.0|-35.37|-12.48|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||-12.48|-35.37|<0.001
91508728|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|3.1||||0.564|TWO_SIDED|95.0|-7.8|14.0|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||14.00|-7.80|0.564
91508729|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|27.03|||<|0.001|TWO_SIDED|95.0|15.96|38.09|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||38.09|15.96|<0.001
91508730|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-1.74||||0.813|TWO_SIDED|95.0|-16.7|13.22|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||13.22|-16.70|0.813
91508731|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|2.35||||0.73|TWO_SIDED|95.0|-11.47|16.17|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||16.17|-11.47|0.730
91508732|NCT04074317|182889503|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|4.09||||0.582|TWO_SIDED|95.0|-10.97|19.15|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||19.15|-10.97|0.582
91508733|NCT04074317|182889509|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80-125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|37.04|||<|0.0001|TWO_SIDED|90.0|31.36|43.75||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||43.75|31.36|<0.0001
91508734|NCT04074317|182889510|OTHER||Ratio of least-square means|435.96|||<|0.0001|TWO_SIDED|||||Results of the statistical evaluation of ANOVA (alpha = 0.05) for the hypothesis of equal treatment effects.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||<0.0001
91508735|NCT04074317|182889511|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|60.44||||0.0075|TWO_SIDED|90.0|45.41|80.43||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.43|45.41|0.0075
91508736|NCT04074317|182889511|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|93.32||||0.6773|TWO_SIDED|90.0|70.14|124.16||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA|Based on Least-Squares geometric means for ln-transformed data.|"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||124.16|70.14|0.6773
91508737|NCT04074317|182889511|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|97.43||||0.8768|TWO_SIDED|90.0|72.94|130.14||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||130.14|72.94|0.8768
91508738|NCT04074317|182889512|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.83|||<|0.0001|TWO_SIDED|90.0|44.51|65.11||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was ana analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||65.11|44.51|<0.0001
91513423|NCT02328326|182898553|SUPERIORITY||Mean Difference (Net)|0.4||||0.01|TWO_SIDED|95.0|0.09|0.71|||Regression, Linear|Model was adjusted for baseline value of SE, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.||0.71|0.09|0.01
91532891|NCT01764386|182942727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.65|||<|0.0001|TWO_SIDED|95.0|-10.07|-7.24|||ANCOVA|||||-7.24|-10.07|<0.0001
91754885|NCT01541917|183402719|SUPERIORITY_OR_OTHER||Slope|-0.004|STANDARD_ERROR_OF_MEAN|0.008||0.67|TWO_SIDED|95.0|-0.02|0.013|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.013|-.02|.67
91754886|NCT01541917|183402720|SUPERIORITY_OR_OTHER||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.58|TWO_SIDED|95.0|-0.01|0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.01|-.01|.58
91754887|NCT01541917|183402720|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.007||0.49|TWO_SIDED|95.0|-0.009|0.018|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.018|-.009|.49
91754888|NCT00121641|183402734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.33|-0.90|<.0001
91754889|NCT00121641|183402734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.93|-0.36||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.36|-0.93|<.0001
91754890|NCT00121641|183402734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.02|-0.44||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.44|-1.02|<.0001
91754891|NCT00121641|183402735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|5.53||0.0002|TWO_SIDED|95.0|-31.47|-9.72||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-9.72|-31.47|0.0002
91754892|NCT00121641|183402735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|STANDARD_ERROR_OF_MEAN|5.48||0.0074|TWO_SIDED|95.0|-25.5|-3.97||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-3.97|-25.50|0.0074
91754893|NCT00121641|183402735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.81|STANDARD_ERROR_OF_MEAN|5.58|<|0.0001|TWO_SIDED|95.0|-33.79|-11.84||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-11.84|-33.79|<.0001
91754894|NCT00121641|183402736|SUPERIORITY_OR_OTHER||Difference in Proportions|11.1||||0.1141|TWO_SIDED|95.0|-3.1|24.9||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||24.9|-3.1|0.1141
91754895|NCT00121641|183402736|SUPERIORITY_OR_OTHER||Difference in Proportions|14.0||||0.0443|TWO_SIDED|95.0|-0.1|27.6||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||27.6|-0.1|0.0443
91754896|NCT00121641|183402736|SUPERIORITY_OR_OTHER||Difference in Proportions|17.1||||0.0133|TWO_SIDED|95.0|2.8|31.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||31.0|2.8|0.0133
91754897|NCT00121641|183402737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6221.0|STANDARD_ERROR_OF_MEAN|1701.3||0.0003|TWO_SIDED|95.0|-9570.0|-2872.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2872|-9570|0.0003
91759736|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||10.16|-14.60|
91532892|NCT01764386|182942728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|||<|0.0001|TWO_SIDED|95.0|-7.14|-3.5|||ANCOVA|||||-3.50|-7.14|<0.0001
91532893|NCT01764386|182942729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.4||||0.0019|TWO_SIDED|95.0|-29.5|-3.3|||ANCOVA|||||-3.3|-29.5|0.0019
91508739|NCT04074317|182889512|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|73.16||||0.0192|TWO_SIDED|90.0|61.06|87.67||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||87.67|61.06|0.0192
91508740|NCT04074317|182889512|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|135.91||||0.0244|TWO_SIDED|90.0|113.1|163.31||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||163.31|113.10|0.0244
91754898|NCT00121641|183402737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6249.0|STANDARD_ERROR_OF_MEAN|1675.1||0.0002|TWO_SIDED|95.0|-9546.0|-2952.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2952|-9546|0.0002
91754899|NCT00121641|183402737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7437.0|STANDARD_ERROR_OF_MEAN|1707.6|<|0.0001|TWO_SIDED|95.0|-10798.0|-4076.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-4076|-10798|<.0001
91754900|NCT01792518|183402772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.78|-0.43|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change in HbA1c is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline HbA1c by visit and baseline log10 (UACR) by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||-0.43|-0.78|<0.0001
91754901|NCT01792518|183402773|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.94||||0.1954|TWO_SIDED|95.0|0.85|1.03|||ANCOVA||Ratio of relative change for Linagliptin 5 mg over placebo is presented.|Superiority of Linagliptin 5 mg vs. placebo: change in UACR is analysed using analysis of covariance model. Model includes baseline HbA1c and baseline log10 (UACR) as linear covariates and treatment as fixed effect.||1.03|0.85|0.1954
91754902|NCT01792518|183402774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|2.7||0.3306|TWO_SIDED|95.0|-7.95|2.68|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Change in eGFR is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline eGFR, baseline HbA1c by visit, baseline log10 (UACR) by visit and baseline eGFR by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||2.68|-7.95|0.3306
91754903|NCT03263780|183402775|SUPERIORITY||Sensitivity|0.25||||0.056|TWO_SIDED|95.0|0.19|0.46||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)||0.46|0.19|0.056
91754904|NCT03263780|183402775|SUPERIORITY||Sensitivity|0.56||||0.56|TWO_SIDED|95.0|0.44|0.78||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)||0.78|0.44|0.56
91754905|NCT03263780|183402775|SUPERIORITY||Sensitivity|0.22||||0.06|TWO_SIDED|95.0|0.17|0.47||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)||0.47|0.17|0.060
91754906|NCT03263780|183402775|SUPERIORITY||Sensitivity|0.5||||0.083|TWO_SIDED|95.0|0.39|0.74||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)||0.74|0.39|0.083
91754907|NCT03263780|183402776|SUPERIORITY||Sensitivity|0.35||||0.096|TWO_SIDED|95.0|0.26|0.65||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)||0.65|0.26|0.096
91754908|NCT03263780|183402776|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)||0.90|0.46|0.317
91532894|NCT01764386|182942730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.9686|TWO_SIDED|95.0|-5.96|5.73|||ANCOVA|||||5.73|-5.96|0.9686
91532895|NCT01764386|182942731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.0001|TWO_SIDED|95.0|1.99|6.06|||ANCOVA|||||6.06|1.99|0.0001
91759737|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.91|||||TWO_SIDED|95.0|-8.22|20.04|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||20.04|-8.22|
91532896|NCT01764386|182942732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.1706|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|||||0.9|-4.9|0.1706
91532897|NCT01764386|182942733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.716|TWO_SIDED|95.0|-2.6|1.8|||ANCOVA|||||1.8|-2.6|0.7160
91508741|NCT04074317|182889513|OTHER||Ratio of least-square means|73.53||||0.2541|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.2541
91508742|NCT04074317|182889513|OTHER||Ratio of least-squares means|103.89|||>|0.9999|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||>0.9999
91508743|NCT04074317|182889513|OTHER||Ratio of least-square means|141.29||||0.1747|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as Regular Insulin least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.1747
91508744|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.16|||<|0.0001|TWO_SIDED|90.0|43.59|64.83||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||64.83|43.59|<0.0001
91508745|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|65.24||||0.0018|TWO_SIDED|90.0|54.02|78.8||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||78.80|54.02|0.0018
91532898|NCT01764386|182942734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.0913|TWO_SIDED|95.0|-0.3|4.3|||ANCOVA|||||4.3|-0.3|0.0913
91754909|NCT03263780|183402776|SUPERIORITY||Sensitivity|0.3||||0.063|TWO_SIDED|95.0|0.23|0.66||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)||0.66|0.23|0.063
91754910|NCT03263780|183402776|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)||0.90|0.46|0.317
91754911|NCT00424268|183402782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
91754912|NCT00424268|183402783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
91754913|NCT00424268|183402784|SUPERIORITY_OR_OTHER||Rate ratio|0.768|STANDARD_ERROR_OF_MEAN|0.157||0.1957|TWO_SIDED|95.0|0.515|1.146||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.146|0.515|0.1957
91754914|NCT00424268|183402785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0032|TWO_SIDED|95.0|0.1|0.7||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.7|0.1|0.0032
91754915|NCT00424268|183402786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|0.9||0.0051|TWO_SIDED|95.0|-4.5|-0.8||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||-0.8|-4.5|0.0051
91754916|NCT02409342|183402865|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.595||||0.0106|TWO_SIDED|95.0|0.398|0.89|||Log Rank|||TC3 or IC3-WT Population||0.890|0.398|0.0106
91754917|NCT02409342|183402866|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.868||||0.3091|TWO_SIDED|95.0|0.661|1.14|||Log Rank|||TC2/3 or IC2/3-WT Population||1.140|0.661|0.3091
91754918|NCT02409342|183402866|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.845||||0.107|TWO_SIDED|95.0|0.688|1.037||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC/1/2/3-WT||1.037|0.688|0.1070
91754919|NCT02409342|183402867|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.63||||0.007|TWO_SIDED|95.0|0.449|0.884||P-value is descriptive as it was not formally tested.|Log Rank|||TC3 or IC3-WT Population||0.884|0.449|0.0070
91754920|NCT02409342|183402868|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.641||||0.0004|TWO_SIDED|95.0|0.501|0.82||P-value is descriptive as it was not formally tested.|Log Rank|||TC2/3 or IC2/3-WT Population||0.820|0.501|0.0004
91754921|NCT02409342|183402868|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.716||||0.0004|TWO_SIDED|95.0|0.595|0.863||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC1/2/3-WT Population||0.863|0.595|0.0004
91508746|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|122.73||||0.2391|TWO_SIDED|90.0|101.33|148.66||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||148.66|101.33|0.2391
91532899|NCT01764386|182942735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.0016|TWO_SIDED|95.0|-7.2|-1.7|||ANCOVA|||||-1.7|-7.2|0.0016
91532900|NCT01764386|182942736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.0004|TWO_SIDED|95.0|-6.2|-2.0|||ANCOVA|||||-2.0|-6.2|0.0004
91532901|NCT01764386|182942737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.0003|TWO_SIDED|95.0|-1.7|-0.7|||ANCOVA|||||-0.7|-1.7|0.0003
91754922|NCT02409342|183402869|SUPERIORITY|Stratified Analysis|Difference in ORR|9.75|||||TWO_SIDED|95.0|-4.07|23.56||||||TC3 or IC3-WT Population||23.56|-4.07|
91754923|NCT02409342|183402870|SUPERIORITY|Stratified analysis|Difference in ORR|1.64|||||TWO_SIDED|95.0|-9.14|12.42||||||TC2/3 or IC2/3-WT Population||12.42|-9.14|
91754924|NCT02409342|183402870|SUPERIORITY|Stratified analysis|Difference in ORR|-0.72|||||TWO_SIDED|95.0|-8.84|7.39||||||TC1/2/3 or IC1/2/3-WT Population||7.39|-8.84|
91754925|NCT02409342|183402871|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.365|||||TWO_SIDED|95.0|0.166|0.8||||||TC3 or IC3-WT Population||0.800|0.166|
91754926|NCT02409342|183402872|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.235|||||TWO_SIDED|95.0|0.135|0.409||||||TC2/3 or IC2/3-WT Population||0.409|0.135|
91754927|NCT02409342|183402872|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.284|||||TWO_SIDED|95.0|0.19|0.424||||||TC1/2/3 or IC1/2/3-WT Population||0.424|0.190|
91754928|NCT02409342|183402873|SUPERIORITY||Difference in Event Free Rate|14.26|||||TWO_SIDED|95.0|-0.03|28.55||||||1-Year TC3 or IC3-WT Population||28.55|-0.03|
91754929|NCT02409342|183402874|SUPERIORITY||Difference in Event Free Rate|20.7|||||TWO_SIDED|95.0|2.94|38.47||||||2-Years TC3 or IC3-WT Population||38.47|2.94|
91754930|NCT02409342|183402875|SUPERIORITY||Difference in Event Free Rate|4.74|||||TWO_SIDED|95.0|-5.93|15.4||||||1-Year TC2/3 or IC2/3-WT Population||15.40|-5.93|
91754931|NCT02409342|183402875|SUPERIORITY||Difference in Event Free Rate|5.06|||||TWO_SIDED|95.0|-3.27|13.4||||||1-Year TC1/2/3 or IC1/2/3-WT Population||13.40|-3.27|
91754932|NCT02409342|183402876|SUPERIORITY||Difference in Event Free Rate|8.73|||||TWO_SIDED|95.0|-1.99|19.45||||||2-Years TC2/3 or IC2/3-WT Population||19.45|-1.99|
91754933|NCT02409342|183402876|SUPERIORITY||Difference in Event Free Rate|10.94|||||TWO_SIDED|95.0|2.83|19.04||||||2-Years TC1/2/3 or IC1/2/3-WT Population||19.04|2.83|
91754934|NCT02409342|183402877|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.142|||||TWO_SIDED|95.0|0.657|1.984||||||Cough in TC3 or IC3-WT Populations||1.984|0.657|
91754935|NCT02409342|183402877|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.891|||||TWO_SIDED|95.0|0.555|1.43||||||Dyspnoea in TC3 or IC3-WT Populations||1.430|0.555|
91754936|NCT02409342|183402877|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.229|||||TWO_SIDED|95.0|0.737|2.049||||||Chest pain in TC3 or IC3-WT Populations||2.049|0.737|
91754937|NCT02409342|183402879|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.477|2.03||||||Cough for TC3 or IC3-WT Populations||2.030|0.477|
91754938|NCT02409342|183402879|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.955|||||TWO_SIDED|95.0|0.569|1.604||||||Dyspnea for TC3 or IC3-WT Populations||1.604|0.569|
91754939|NCT02409342|183402879|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.024|||||TWO_SIDED|95.0|0.472|2.222||||||Chest pain for TC3 or IC3-WT Populations||2.222|0.472|
91754940|NCT02409342|183402880|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.707|||||TWO_SIDED|95.0|0.5|1.0||||||SP263 \>=50%-WT Population||1.000|0.500|
91754941|NCT02409342|183402880|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.502|0.956||||||SP263 \>=25%-WT Population||0.956|0.502|
91754942|NCT02409342|183402880|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.579|1.018||||||SP263 \>=1%-WT Population||1.018|0.579|
91754943|NCT02409342|183402881|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.674|||||TWO_SIDED|95.0|0.511|0.89||||||SP263 \>=50%-WT Population||0.890|0.511|
91754944|NCT02409342|183402881|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.698|||||TWO_SIDED|95.0|0.539|0.904||||||SP263 \>=25%-WT Population||0.904|0.539|
91754945|NCT02409342|183402881|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.725|||||TWO_SIDED|95.0|0.577|0.91||||||SP263 \>=1%-WT Population||0.910|0.577|
91754946|NCT02409342|183402882|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.867|||||TWO_SIDED|95.0|0.578|1.301||||||bTMB \>=10-WT Population||1.301|0.578|
91754947|NCT02409342|183402882|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.748|||||TWO_SIDED|95.0|0.414|1.351||||||bTMB \>=16-WT Population||1.351|0.414|
91754948|NCT02409342|183402882|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.362|1.638||||||bTMB \>=20-WT Population||1.638|0.362|
91754949|NCT02409342|183402883|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.525|1.052||||||bTMB \>=10-WT Population||1.052|0.525|
91754950|NCT02409342|183402883|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.553|||||TWO_SIDED|95.0|0.331|0.924||||||bTMB \>=16-WT Population||0.924|0.331|
91754951|NCT02409342|183402883|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.295|1.062||||||bTMB \>=20-WT Population||1.062|0.295|
91754952|NCT00279812|183402888|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91754953|NCT00279812|183402889|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91754954|NCT00279812|183402890|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91754955|NCT03907033|183402892|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Hydrocodone use||||1.000
91754956|NCT03907033|183402892|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Oxycodone use||||0.010
91532902|NCT01764386|182942738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.8|-6.0|||ANCOVA|||||-6.0|-9.8|<0.0001
91754957|NCT03907033|183402893|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Ibuprofen use||||0.248
91754958|NCT03907033|183402893|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Tylenol use||||1.000
91754959|NCT03907033|183402895|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 24 hours post-surgery||||0.846
91532903|NCT01764386|182942739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||||-1.1|-3.1|<0.0001
91754960|NCT03907033|183402895|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 48 hours post-surgery||||0.490
91754961|NCT03907033|183402895|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 72 hours post-surgery||||0.564
91754962|NCT03907033|183402896|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 24 hours post-surgery||||0.264
91754963|NCT03907033|183402896|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 48 hours post-surgery||||0.970
91508747|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|54.2|||<|0.0001|TWO_SIDED|90.0|47.58|61.73||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||61.73|47.58|<0.0001
91754964|NCT03907033|183402896|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 72 hours post-surgery||||0.536
91754965|NCT03907033|183402897|SUPERIORITY|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 24 hours post-surgery||||0.957
91754966|NCT03907033|183402897|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 48 hours post-surgery||||0.353
91754967|NCT03907033|183402897|SUPERIORITY|||||||0.165|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.165
91754968|NCT03907033|183402899|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.802
91754969|NCT03907033|183402899|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 7-10 days post-surgery||||0.656
91754970|NCT02020408|183402919|SUPERIORITY||||||>|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|ANOVA|||||||> 0.05
91754971|NCT02020408|183402920|SUPERIORITY||||||<|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|General Linear Model|||A General Linear Model using log(\[11C\]raclopride BPND) after amphetamine administration as dependent variable and Diagnostic Group as independent variable was used. Baseline (before amphetamine administration) \[11C\]raclopride BPND was used as covariate.||||<0.05
91754972|NCT02720692|183402955|SUPERIORITY||||||<|0.05||||||P\<0.05 applies to Day 1 (0-24 Hours; p=0.0033), Days 1-2 (0-48 Hours; p=0.0077), and Days 1-3 (0-72 Hours; p=0.0152).|ANCOVA|||||||<0.05
91754973|NCT01206582|183402956|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0002
91532904|NCT01764386|182942740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.0001|TWO_SIDED|95.0|13.45|21.36|||ANCOVA|||||21.36|13.45|<0.0001
91754974|NCT01206582|183402956|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Comparison for day 7||||0.008
91754975|NCT01206582|183402957|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0003
91754976|NCT01206582|183402964|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
91754977|NCT01206582|183402965|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
91754978|NCT01206582|183402966|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Comparison for Platelets on Day 4||||0.01
91754979|NCT00528801|183402967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.07||0.008||95.0|||||Mixed Models Analysis|Adjusted for gender, age, and education.|Cases are lower than controls.|Null hypothesis is no difference between cases and controls in the WAIS-III Perormance IQ (PIQ) Index. A linear model controlling for gender, age, and education was used to compare controls versus cases using an F statistic. Based on sample-size calculations, 120 patients and 36 controls were needed to have 80% power to detect an 8-point difference on the WAIS-III PIQ Index.||||0.008
91754980|NCT00528801|183402968|SUPERIORITY_OR_OTHER||Difference in proportions|0.11||||0.048||95.0|0.026|0.199|||Fisher Exact|||Null hypothesis is no difference between cases and controls in the proportion of subjects with lacunae. This was tested using a Fisher's Exact Test.||.199|.026|0.048
91754981|NCT02207491|183402970|NON_INFERIORITY|Clinical noninferiority was to be concluded if the upper limit of the 95% CIs around the difference (AR-13324 - timolol) was within 1.5 mmHg at all time points and was within 1.0 mmHg at a majority of the time points.|||||<|0.0001||||||Calculated p-value|ANCOVA|Statistical analysis applies at all 3 timepoints on Day 15, Day 43, and Day 90||Assuming zero difference between AR-13324 and timolol, a 2-tailed alpha of 0.05 at each of 9 time points, a common SD of 3.0 mmHg, and a correlation between time points of 0.60 or less, 170 PP subjects per arm were necessary to have 90% power to show clinical noninferiority of AR-13324 to timolol in mean IOP.||||<0.0001
91754982|NCT01939366|183402997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.37||0.0621|TWO_SIDED|95.0|-1.43|0.04||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.04|-1.43|0.0621
91754983|NCT01939366|183402997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.39||0.0564|TWO_SIDED|95.0|-1.5|0.02||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.02|-1.50|0.0564
91759738|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-0.29|31.4|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||31.40|-0.29|
91508748|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|71.29||||0.0002|TWO_SIDED|90.0|62.99|80.69||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.69|62.99|0.0002
91508749|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|131.55||||0.0026|TWO_SIDED|90.0|116.01|149.17||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||149.17|116.01|0.0026
91754984|NCT01939366|183402997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.41||0.0153|TWO_SIDED|95.0|-1.83|-0.2||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||-0.20|-1.83|0.0153
91754985|NCT03242252|183403071|SUPERIORITY||Difference in Least Squares (LS) Means|-0.1|STANDARD_ERROR_OF_MEAN|0.076||0.2095|TWO_SIDED|95.0|-0.245|0.054|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.054|-0.245|0.2095
91754986|NCT03242252|183403071|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0021|TWO_SIDED|95.0|-0.386|-0.085|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.085|-0.386|0.0021
91754987|NCT03242252|183403072|SUPERIORITY||Difference in LS Means|-0.587|STANDARD_ERROR_OF_MEAN|0.2397||0.0144|TWO_SIDED|95.0|-1.0564|-0.1169|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.1169|-1.0564|0.0144
91754988|NCT03242252|183403072|SUPERIORITY||Difference in LS Means|-0.478|STANDARD_ERROR_OF_MEAN|0.2368||0.0436|TWO_SIDED|95.0|-0.942|-0.0136|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.0136|-0.942|0.0436
91754989|NCT03242252|183403073|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|2.034||0.2627|TWO_SIDED|95.0|-6.265|1.709|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.709|-6.265|0.2627
91754990|NCT03242252|183403073|SUPERIORITY||Difference in LS Means|-2.53|STANDARD_ERROR_OF_MEAN|1.799||0.1602|TWO_SIDED|95.0|-6.052|1.0|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1|-6.052|0.1602
91754991|NCT03242252|183403074|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|1.301||0.2212|TWO_SIDED|95.0|-4.142|0.958|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.958|-4.142|0.2212
91754992|NCT03242252|183403074|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|1.297||0.2089|TWO_SIDED|95.0|-4.171|0.912|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.912|-4.171|0.2089
91754993|NCT03242252|183403075|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|-1.92|-0.644|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.644|-1.92|< 0.0001
91759739|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.16|||||TWO_SIDED|95.0|-4.7|25.03|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||25.03|-4.70|
91754994|NCT03242252|183403075|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.339||0.0155|TWO_SIDED|95.0|-1.487|-0.156|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.156|-1.487|0.0155
91754995|NCT03242252|183403076|SUPERIORITY||Percent Difference|-30.72||||0.0015|TWO_SIDED|95.0|-44.78|-13.07|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-13.07|-44.78|0.0015
91754996|NCT03242252|183403076|SUPERIORITY||Percent Difference|-36.18||||0.0003|TWO_SIDED|95.0|-49.91|-18.68|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-18.68|-49.91|0.0003
91754997|NCT03242252|183403077|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.23|5.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.21|-2.23|0.4328
91754998|NCT03242252|183403077|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.2|5.17|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.17|-2.2|0.4328
91754999|NCT03242252|183403078|SUPERIORITY||Percentage Difference|6.0||||0.0614|TWO_SIDED|95.0|-0.23|12.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||12.21|-0.23|0.0614
91755000|NCT03242252|183403078|SUPERIORITY||Percentage Difference|7.4||||0.023|TWO_SIDED|95.0|1.08|13.65|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||13.65|1.08|0.023
91755001|NCT00530920|183403117|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.43||||0.997|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.997
91755002|NCT00530920|183403117|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.55||||1|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||1
91755003|NCT00530920|183403117|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.47||||0.998|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.998
91755004|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3598|TWO_SIDED|95.0|0.53|1.26|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.26|0.53|0.3598
91755005|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6544|TWO_SIDED|95.0|0.59|1.39|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.39|0.59|0.6544
91755006|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.64|1.58|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.58|0.64|0.9958
91759740|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-16.16|7.27|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||7.27|-16.16|
91759741|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.97|||||TWO_SIDED|95.0|-0.68|30.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||30.63|-0.68|
91508750|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|51.34|||<|0.0001|TWO_SIDED|90.0|46.74|56.39||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||56.39|46.74|<0.0001
91759742|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
91508751|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|78.24||||0.0003|TWO_SIDED|90.0|71.39|85.76||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||85.76|71.39|0.0003
91508752|NCT04074317|182889514|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|152.41|||<|0.0001|TWO_SIDED|90.0|138.91|167.22||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||167.22|138.91|<0.0001
91508753|NCT02742103|182889523|OTHER||Rate difference (CSL112 - placebo)|-0.124|||||TWO_SIDED|95.0|-0.296|-0.005|||Newcombe-Wilson|||||-0.005|-0.296|
91508754|NCT02742103|182889524|OTHER||Rate difference (CSL112 - placebo)|-0.103|||||TWO_SIDED|95.0|-0.277|0.025|||Newcombe-Wilson|||||0.025|-0.277|
91508755|NCT02533921|182889540|SUPERIORITY||Mean Difference (Final Values)|1.5022|STANDARD_ERROR_OF_MEAN|0.6749||0.0272|TWO_SIDED|95.0|0.1706|2.8338|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||2.8338|0.1706|0.0272
91508756|NCT02533921|182889541|SUPERIORITY||Mean Difference (Final Values)|-1.1236|STANDARD_ERROR_OF_MEAN|0.8267||0.1761|TWO_SIDED|95.0|-2.7569|0.5097|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.5097|-2.7569|0.1761
91508757|NCT02533921|182889542|SUPERIORITY||Mean Difference (Final Values)|-0.4616|STANDARD_ERROR_OF_MEAN|0.3889||0.2369|TWO_SIDED|95.0|-1.2291|0.3059|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.3059|-1.2291|0.2369
91755007|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6276|TWO_SIDED|95.0|0.59|1.37|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.37|0.59|0.6276
91508758|NCT02533921|182889543|SUPERIORITY||Mean Difference (Final Values)|-0.1309||||0.7484|TWO_SIDED|95.0|-0.9349|0.673|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|||0.6730|-0.9349|0.7484
91508759|NCT02533921|182889544|SUPERIORITY||Mean Difference (Final Values)|-0.6878|STANDARD_ERROR_OF_MEAN|0.4789||0.1529|TWO_SIDED|95.0|-1.6338|0.2581|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.2581|-1.6338|0.1529
91508760|NCT02533921|182889545|SUPERIORITY||Mean Difference (Final Values)|-0.1608|STANDARD_ERROR_OF_MEAN|0.3934||0.6834|TWO_SIDED|95.0|-0.9382|0.6167|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.6167|-0.9382|0.6834
91508761|NCT00533949|182889546|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.38||||0.0042|TWO_SIDED|95.0|1.09|1.76|||Log Rank||Reference group = 60 gy|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.76|1.09|0.0042
91755008|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8819|TWO_SIDED|95.0|0.63|1.49|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.49|0.63|0.8819
91755009|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7197|TWO_SIDED|95.0|0.6|1.42|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.42|0.60|0.7197
91755010|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6204|TWO_SIDED|95.0|0.73|1.7|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.70|0.73|0.6204
91759743|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.09|||||TWO_SIDED|95.0|-5.9|18.1|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||18.10|-5.90|
91755011|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4779|TWO_SIDED|95.0|0.75|1.84|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.84|0.75|0.4779
91755012|NCT00907296|183403134|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9952|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9952
91508762|NCT00533949|182889546|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07||||0.29|TWO_SIDED|95.0|0.84|1.35|||Log Rank||Reference level = cetuximab|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.35|0.84|0.29
91508763|NCT00533949|182889547|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.19||||0.12|TWO_SIDED|95.0|0.95|1.47|||Log Rank||Reference level = 60 Gy|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.47|0.95|0.12
91755013|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1713|TWO_SIDED|95.0|0.47|1.14|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.14|0.47|0.1713
91759744|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
91759745|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.84|||||TWO_SIDED|95.0|-8.96|12.64|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||12.64|-8.96|
91759746|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-7.27|16.16|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||16.16|-7.27|
91759747|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.2|||||TWO_SIDED|95.0|-7.37|15.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.77|-7.37|
91759748|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.69|||||TWO_SIDED|95.0|-16.83|-0.55|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-0.55|-16.83|
91759749|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-14.39|5.7|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||5.70|-14.39|
91759750|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.47|||||TWO_SIDED|95.0|-15.68|2.73|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||2.73|-15.68|
91759751|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.31|||||TWO_SIDED|95.0|-13.04|8.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||8.41|-13.04|
91759752|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.21|||||TWO_SIDED|95.0|-25.59|-4.83|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-4.83|-25.59|
91759753|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.7|||||TWO_SIDED|95.0|-19.79|6.38|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||6.38|-19.79|
91759754|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.33|||||TWO_SIDED|95.0|-14.49|15.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.16|-14.49|
91759755|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.8|||||TWO_SIDED|95.0|-13.13|16.74|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||16.74|-13.13|
91759756|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-19.51|||||TWO_SIDED|95.0|-32.19|-6.84|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-6.84|-32.19|
91759757|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.97|||||TWO_SIDED|95.0|-24.24|6.29|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||6.29|-24.24|
91759758|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.4|||||TWO_SIDED|95.0|-23.92|7.1|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||7.10|-23.92|
91759759|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.71|||||TWO_SIDED|95.0|-20.76|11.32|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||11.32|-20.76|
91759760|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-17.19|||||TWO_SIDED|95.0|-32.36|-2.02|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-2.02|-32.36|
91508764|NCT00533949|182889547|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.8|1.22|||Log Rank||Reference level = cetuximab|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05.||1.22|0.80|0.89
91508765|NCT00533949|182889548|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.24|TWO_SIDED|95.0|0.89|1.53|||Gray's test||Reference level = 60 Gy|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.53|0.89|0.24
91508766|NCT00533949|182889548|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.22|TWO_SIDED|95.0|0.64|1.1|||Gray's test||Reference level = cetuximab|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.10|0.64|0.22
91508767|NCT00533949|182889549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Esophagitis: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||<0.0001
91508768|NCT00533949|182889549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|||||||Chi-squared|||PNEUMONITIS: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||0.2533
91508769|NCT00533949|182889550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Chi-squared|||Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of of toxicity at any time was classified by a binary grouping of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test.||||0.52
91508770|NCT00533949|182889552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0233|||||||Cochran-Mantel-Haenszel|||FACT-TOI-LCS was assessed and changes from baseline to 3 months calculated and grouped using a 2 point decline as the threshold. Comparisons of decline vs no decline by RT level were from a Cochran-Mantel-Haenszel test and controlling for cetuximab assignment using a two-side significance level of 0.05.||||0.0233
91508771|NCT00533949|182889553|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.92
91755014|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9958
91755015|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.295|TWO_SIDED|95.0|0.81|1.97|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.97|0.81|0.2950
91755016|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0844|TWO_SIDED|95.0|0.44|1.05|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.05|0.44|0.0844
91755017|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3225|TWO_SIDED|95.0|0.52|1.24|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.24|0.52|0.3225
91755018|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.4754|TWO_SIDED|95.0|0.76|1.81|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.81|0.76|0.4754
91755019|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5578|TWO_SIDED|95.0|0.74|1.75|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.75|0.74|0.5578
91755020|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.1864|TWO_SIDED|95.0|0.87|2.07|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||2.07|0.87|0.1864
91755021|NCT00907296|183403137|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8488|TWO_SIDED|95.0|0.68|1.59|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.59|0.68|0.8488
91755022|NCT01177969|183403152|SUPERIORITY_OR_OTHER|||||||0.04||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.04
91755023|NCT01177969|183403153|SUPERIORITY_OR_OTHER|||||||0.25||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.25
91508772|NCT00533949|182889554|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.19
91508773|NCT00533949|182889555|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.78|TWO_SIDED|95.0|0.68|1.33|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of overall survival by EGFR group||1.33|0.68|0.78
91508774|NCT00533949|182889555|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.61|TWO_SIDED|95.0|0.74|1.65|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of time to local-regional failure by EGFR group||1.65|0.74|0.61
91508775|NCT00533949|182889556|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Chi-squared|||||||0.02
91508776|NCT00533949|182889557|OTHER||Cox Proportional Hazard|1.001||||0.06|TWO_SIDED|95.0|1.0|1.002||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Univariate model with GTV as a continuous variable||1.002|1.000|0.06
91508777|NCT00533949|182889557|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.78|TWO_SIDED|95.0|0.997|1.004||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Multivariate model with GTV as a continuous variable, adjusting for planned radiation therapy dose group (60 Gy or 74 Gy) and the interaction of GTV and planned dose.|P-Value for the interaction of GTV and planned dose = 0.77|1.004|0.997|0.78
91508778|NCT00533949|182889558|SUPERIORITY||Cox Proportional Hazard|1.0||||0.94|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of overall survival time by PET SUV as a continuous variable||1.02|0.98|0.94
91508779|NCT00533949|182889558|SUPERIORITY||Cox Proportional Hazard|1.0||||0.72|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to local-regional failure by PET SUV as a continuous variable||1.02|0.98|0.72
91508780|NCT00533949|182889558|SUPERIORITY||Cox Proportional Hazard|1.0||||0.79|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to distant metastasis by PET SUV as a continuous variable||1.02|0.98|0.79
91755024|NCT04468074|183403173|SUPERIORITY||Mean Difference (Net)|1.0||||0.014|TWO_SIDED||||||Mixed Models Analysis|||||||0.014
91508781|NCT00727194|182889560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.25||||0.0144|TWO_SIDED|95.0|-7.45|-1.05||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||-1.05|-7.45|0.0144
91508782|NCT00727194|182889560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.71||||0.117|TWO_SIDED|95.0|-10.8|1.37||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||1.37|-10.80|0.1170
91508783|NCT00727194|182889561|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||1.0000
91508784|NCT00727194|182889561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||0.0606
91508785|NCT00727194|182889562|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.58||||0.1873|TWO_SIDED|95.0|-4.08|0.91||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||0.91|-4.08|0.1873
91508786|NCT00727194|182889562|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.57||||0.041|TWO_SIDED|95.0|-6.97|-0.17||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||-0.17|-6.97|0.0410
91508787|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83||||0.919|TWO_SIDED|95.0|-16.94|18.6||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Physical Functioning||18.60|-16.94|0.9190
91508788|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.86||||0.5931|TWO_SIDED|95.0|-39.05|23.33||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Functioning||23.33|-39.05|0.5931
91508789|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|3.13||||0.7319|TWO_SIDED|95.0|-16.64|22.89||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Role Physical||22.89|-16.64|0.7319
91508790|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-7.14||||0.691|TWO_SIDED|95.0|-45.36|31.08||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Physical||31.08|-45.36|0.6910
91508791|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.42||||0.1311|TWO_SIDED|95.0|-22.18|3.34||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Bodily Pain||3.34|-22.18|0.1311
91508792|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.86||||0.2406|TWO_SIDED|95.0|-41.08|11.36||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Bodily Pain||11.36|-41.08|0.2406
91508793|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.17||||0.0578|TWO_SIDED|95.0|-0.29|14.62||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||General Health||14.62|-0.29|0.0578
91508794|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.43||||0.5073|TWO_SIDED|95.0|-16.26|31.11||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||General Health||31.11|-16.26|0.5073
91508795|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.17||||0.2474|TWO_SIDED|95.0|-3.39|11.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Vitality||11.72|-3.39|0.2474
91508796|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.68||||0.8085|TWO_SIDED|95.0|-26.24|20.88||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Vitality||20.88|-26.24|0.8085
91755025|NCT04468074|183403174|SUPERIORITY||Mean Difference (Net)|2.79||||0.0159|TWO_SIDED||||||Mixed Models Analysis|||||||0.0159
91755026|NCT04468074|183403175|SUPERIORITY||Median Difference (Net)|-3.85||||0.0066|TWO_SIDED||||||Mixed Models Analysis|||||||0.0066
91755027|NCT03995355|183403224|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|11.3|STANDARD_ERROR_OF_MEAN|4.44|||TWO_SIDED|95.0|2.6|20.1|||Linear Mixed Model Analysis||Least square mean difference was calculated as Test minus Control|||20.1|2.6|
91508797|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.46||||0.0716|TWO_SIDED|95.0|-24.13|1.21||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Social Functioning||1.21|-24.13|0.0716
91508798|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.07||||0.1966|TWO_SIDED|95.0|-41.68|9.54||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Social Functioning||9.54|-41.68|0.1966
91755028|NCT03995355|183403225|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|2.6|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-5.3|10.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||10.4|-5.3|
91755029|NCT03995355|183403226|OTHER||Odds Ratio (OR)|0.967|||||TWO_SIDED|95.0|0.528|1.77|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|||1.770|0.528|
91755030|NCT03995355|183403226|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.61|2.203|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|30-Day follow-up||2.203|0.610|
91755031|NCT03995355|183403227|OTHER||Odds Ratio (OR)|1.601|||||TWO_SIDED|95.0|0.178|19.616|||Fisher Exact||Odds ratio was calculated as Test over Control|||19.616|0.178|
91508799|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81||||0.1701|TWO_SIDED|95.0|-29.6|5.99||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Role Emotional||5.99|-29.60|0.1701
91755032|NCT03995355|183403228|OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|0.7|15.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||15.4|0.7|
91755033|NCT03995355|183403229|OTHER||Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.86|||TWO_SIDED|95.0|1.7|17.0|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||17.0|1.7|
91755034|NCT00343382|183403239|SUPERIORITY_OR_OTHER|||||||0.1675|||||||Kruskal-Wallis|||||||0.1675
91755035|NCT00343382|183403239|SUPERIORITY_OR_OTHER|||||||0.5974|||||||Kruskal-Wallis|||||||0.5974
91755036|NCT00343382|183403240|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||Comparison of Rigors among arms.||||0.002
91508800|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.95||||0.7422|TWO_SIDED|95.0|-32.58|44.48||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Emotional||44.48|-32.58|0.7422
91755037|NCT00343382|183403240|SUPERIORITY_OR_OTHER|||||||0.006|||||||Kruskal-Wallis|||Comparison of Urinary Frequency among arms||||0.006
91755038|NCT00343382|183403240|SUPERIORITY_OR_OTHER|||||||0.03|||||||Kruskal-Wallis|||Comparison of nausea among arms||||0.030
91755039|NCT00343382|183403240|SUPERIORITY_OR_OTHER|||||||0.062|||||||Kruskal-Wallis|||Comparison of sweating among arms||||0.062
91755040|NCT03945019|183403243|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
91755041|NCT03945019|183403244|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
91755042|NCT03002454|183403257|EQUIVALENCE|"Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment~Anticipated sample size of 50 participants with sample size parameters of:~Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%~Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted."|||||||||||||||||No statistical analysis - insufficient study population|||
91755043|NCT04075409|183403294|OTHER||LS means ratio|1.426|||||TWO_SIDED|90.0|1.112|1.83|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% Confidence Intervals (CIs) were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.830|1.112|
91755044|NCT04075409|183403294|OTHER||LS means ratio|1.234|||||TWO_SIDED|90.0|0.9619|1.584|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.584|0.9619|
91759761|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.06|||||TWO_SIDED|95.0|-25.69|7.56|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||7.56|-25.69|
91508801|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.9007|TWO_SIDED|95.0|-6.83|7.67||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Health||7.67|-6.83|0.9007
91508802|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.86||||0.1519|TWO_SIDED|95.0|-7.57|43.29||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Health||43.29|-7.57|0.1519
91508803|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.07||||0.6807|TWO_SIDED|95.0|-4.57|6.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Physical Component Score||6.72|-4.57|0.6807
91508804|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.23||||0.2226|TWO_SIDED|95.0|-16.79|4.32||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Component Score||4.32|-16.79|0.2226
91508805|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.92||||0.1505|TWO_SIDED|95.0|-7.1|1.26||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Component Score||1.26|-7.10|0.1505
91508806|NCT00727194|182889563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.55||||0.4151|TWO_SIDED|95.0|-8.77|19.87||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Component Score||19.87|-8.77|0.4151
91508807|NCT00727194|182889564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.25||||0.3377|TWO_SIDED|95.0|-3.94|10.44||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Forced Vital Capacity||10.44|-3.94|0.3377
91508808|NCT00727194|182889564|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-10.57||||0.3391|TWO_SIDED|95.0|-33.71|12.56||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Forced Vital Capacity||12.56|-33.71|0.3391
91508809|NCT00727194|182889564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-4.35|4.35||No multiple comparisons or multiplicity adjustments were conducted.|paired t test|||Negative Inspiratory Force||4.35|-4.35|1.0000
91508810|NCT00727194|182889564|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.57||||0.2292|TWO_SIDED|95.0|-17.87|4.73||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Negative Inspiratory Force||4.73|-17.87|0.2292
91508811|NCT04269161|182889576|NON_INFERIORITY|The margin of non-inferiority is 10 seconds such that the device is no worse than 10 seconds on average than manual mode. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|-9.885||||0.003|TWO_SIDED|95.0|-16.51|-3.27||The p-value is significant at 0.01.|t-test, 2 sided||The difference is time to re-establish in automatic mode minus time to re-establish in manual mode. (a negative number favors automatic mode)|A sample requirement of 48 patients was determined based on a pilot study to provide 88% power, and 0.05 significance (two sided) to show the mean difference is less than 10 seconds based on a 2x2 crossover design. Considering patient drop-out, a sample size of n=40 drops power to 82%.||-3.27|-16.51|0.003
91508812|NCT04269161|182889577|OTHER|The difference is defined as the difference of proportion of time in the target range of SpO2 in modes, automatic minus manual. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|0.018||||0.02|TWO_SIDED|95.0|0.003|0.034||The threshold for statistical significance is p=.05|t-test, 2 sided|Two-sample t test with equal variances. Linear mixed model patient random effects, adjusted for site, sex, race, weight, gestational age, bed type.|Treatment difference = automatic - manual. A positive number favors automatic.|The difference in the proportion of time in the target saturation is calculated between the automatic and manual models. For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range.||.034|0.003|.02
91508813|NCT02896127|182889607|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.65|3.69|||Regression, Logistic||||"PTFU=post-treatment follow-up (12 weeks after last study treatment)~95% confidence intervals are from a score method with continuity correction."|3.69|1.65|<.0001
91508814|NCT00958776|182889623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.973|TWO_SIDED|95.0|0.69|1.55|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.55|0.69|0.973
91532905|NCT01341080|182942808|OTHER||Cohen's d|0.15||||0.05|TWO_SIDED|95.0|-4.01|4.61|||Repeated measures analysis or variance|||Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of study after 8 weeks on drug. The BBS has a scale range of 0-56, with 56 indicating normal balance. To evaluate efficacy, repeated measures analysis of variance was run on BBS scores. The scale score was the dependent measure, time point (baseline or end of study) was the repeat measure, and treatment group (varenicline or sugar pill) was the independent measure. Significance was defined as alpha \<0.05.||4.61|-4.01|0.05
91532906|NCT01341080|182942809|OTHER||Cohen's d|0.16||||0.05|TWO_SIDED|95.0|-1.39|1.53|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Frontal Assessment Battery (FAB) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the FAB scores. Scale cores was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.53|-1.39|0.05
91755045|NCT04075409|183403294|OTHER||LS means ratio|1.156|||||TWO_SIDED|90.0|0.9008|1.483|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.483|0.9008|
91755046|NCT04075409|183403295|OTHER||LS means ratio|2.122|||||TWO_SIDED|90.0|1.706|2.638|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.638|1.706|
91755047|NCT04075409|183403295|OTHER||LS means ratio|1.289|||||TWO_SIDED|90.0|1.037|1.603|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.603|1.037|
91755048|NCT04075409|183403295|OTHER||LS means ratio|1.646|||||TWO_SIDED|90.0|1.323|2.046|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.046|1.323|
91508815|NCT00958776|182889625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.558|TWO_SIDED|95.0|0.75|1.72|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.72|0.75|0.558
91508816|NCT00958776|182889626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.633|TWO_SIDED|95.0|0.59|1.31|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.31|0.59|0.633
91508817|NCT00958776|182889627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.747|TWO_SIDED|95.0|0.92|2.32|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||2.32|0.92|0.747
91508818|NCT00958776|182889629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.303|TWO_SIDED|95.0|0.41|2.98|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio is calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at baseline, use of supplemental oxygen at baseline, influenza season, and influenza type.|||2.98|0.41|0.303
91755049|NCT04075409|183403296|OTHER||LS means ratio|2.124|||||TWO_SIDED|90.0|1.709|2.639|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.639|1.709|
91508819|NCT00958776|182889631|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.768
91508820|NCT00958776|182889632|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.758
91508821|NCT04027218|182889659|SUPERIORITY||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|95.0|2.34|2.79|||McNemar|||||2.79|2.34|0.001
91508822|NCT04027218|182889659|SUPERIORITY||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.7|2.13|||McNemar|||||2.13|1.70|0.002
91755050|NCT04075409|183403296|OTHER||LS means ratio|1.291|||||TWO_SIDED|90.0|1.039|1.604|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.604|1.039|
91755051|NCT04075409|183403296|OTHER||LS means ratio|1.645|||||TWO_SIDED|90.0|1.324|2.044|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.044|1.324|
91755052|NCT04075409|183403299|OTHER||LS means ratio|1.089|||||TWO_SIDED|90.0|0.8859|1.339|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.339|0.8859|
91755053|NCT04075409|183403299|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
91508823|NCT04027218|182889659|SUPERIORITY||Odds Ratio (OR)|1.9||||0.004|TWO_SIDED|95.0|1.87|1.92|||McNemar|||||1.92|1.87|0.004
91508824|NCT04027218|182889660|SUPERIORITY||Median Difference (Net)|-4.179||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
91508825|NCT04027218|182889660|SUPERIORITY||Median Difference (Net)|-3.619||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
91508826|NCT04027218|182889660|SUPERIORITY||Median Difference (Net)|-4.099||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
91508827|NCT04027218|182889661|SUPERIORITY||Median Difference (Net)|-1.073||||0.863|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.863
91508828|NCT04027218|182889661|SUPERIORITY||Median Difference (Net)|-1.267||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.205
91508829|NCT04027218|182889661|SUPERIORITY||Median Difference (Net)|-0.858||||0.391|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.391
91508830|NCT04027218|182889663|SUPERIORITY||Median Difference (Net)|-0.672||||0.502|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.502
91755054|NCT04075409|183403299|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
91508831|NCT04027218|182889663|SUPERIORITY||Median Difference (Net)|-0.327||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.744
91508832|NCT04027218|182889663|SUPERIORITY||Median Difference (Net)|-1.885||||0.059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.059
91508833|NCT00494494|182889665|NON_INFERIORITY_OR_EQUIVALENCE|Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.|Mean Difference (Net)|2.82|STANDARD_DEVIATION|13.8||0.7029|TWO_SIDED|95.0|-3.27|8.91|||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.||8.91|-3.27|0.7029
91508834|NCT00494494|182889666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|STANDARD_DEVIATION|9.56||0.1937|TWO_SIDED|95.0|-2.41|6.43|||Wilcoxon (Mann-Whitney)|||||6.43|-2.41|0.1937
91508835|NCT00494494|182889667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|19.6||0.5066|TWO_SIDED|95.0|-3.12|16.52|||Wilcoxon (Mann-Whitney)|||||16.52|-3.12|0.5066
91508836|NCT00494494|182889668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.21||0.5099|TWO_SIDED|95.0|-0.13|0.227|||Wilcoxon (Mann-Whitney)|||||0.227|-0.13|0.5099
91508837|NCT00494494|182889669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_DEVIATION|5.64||0.5005|TWO_SIDED|95.0|-1.49|3.55|||Wilcoxon (Mann-Whitney)|||||3.55|-1.49|0.5005
91508838|NCT02504372|182889725|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.96|||||HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.96|0.68|
91755055|NCT04075409|183403300|OTHER||LS means ratio|1.344|||||TWO_SIDED|90.0|1.092|1.653|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.653|1.092|
91755056|NCT04075409|183403300|OTHER||LS means ratio|0.9991|||||TWO_SIDED|90.0|0.812|1.229|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.229|0.8120|
91755057|NCT04075409|183403300|OTHER||LS means ratio|1.345|||||TWO_SIDED|90.0|1.093|1.655|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.655|1.093|
91755058|NCT02299076|183403304|SUPERIORITY|Welch Two Sample t-test|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91755059|NCT00162266|183403306|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||||38.4|12.8|<0.001
91755060|NCT00162266|183403306|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31|TWO_SIDED|95.0|-6.2|19.4|||Chi-squared|||||19.4|-6.2|0.31
91755061|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.9||||0.283|TWO_SIDED|95.0|-4.9|16.7|||Chi-squared|||Response on Day 15||16.7|-4.9|0.283
91755062|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-11.6||||0.015|TWO_SIDED|95.0|-20.9|-2.3|||Chi-squared|||Response on Day 15||-2.3|-20.9|0.015
91755063|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.5||||0.067|TWO_SIDED|95.0|-0.8|23.8|||Chi-squared|||Response on Day 30||23.8|-0.8|0.067
91755064|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-9.3||||0.113|TWO_SIDED|95.0|-20.8|2.2|||Chi-squared|||Response on Day 30||2.2|-20.8|0.113
91755065|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|22.1|||<|0.001|TWO_SIDED|95.0|9.3|34.8|||Chi-squared|||Response on Day 60||34.8|9.3|<0.001
91755066|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.1||||0.86|TWO_SIDED|95.0|-13.5|11.3|||Chi-squared|||Response on Day 60||11.3|-13.5|0.86
91755067|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|18.6||||0.004|TWO_SIDED|95.0|5.9|31.4|||Chi-squared|||Response on Day 90||31.4|5.9|0.004
91755068|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.8||||0.664|TWO_SIDED|95.0|-9.8|15.4|||Chi-squared|||Response on Day 90||15.4|-9.8|0.664
91755069|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.9|||<|0.001|TWO_SIDED|95.0|11.1|36.7|||Chi-squared|||Response on Day 120||36.7|11.1|<0.001
91755070|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.9||||0.292|TWO_SIDED|95.0|-6.0|19.9|||Chi-squared|||Response on Day 120||19.9|-6.0|0.292
91755071|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.0|||<|0.001|TWO_SIDED|95.0|10.2|35.8|||Chi-squared|||Response on Day 150||35.8|10.2|<0.001
91755072|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.5||||0.193|TWO_SIDED|95.0|-4.3|21.3|||Chi-squared|||Response on Day 150||21.3|-4.3|0.193
91755073|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||Response on Day 180||38.4|12.8|<0.001
91755074|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31||95.0|-6.2|19.4|||Chi-squared|||Response on Day 180||19.4|-6.2|0.31
91755075|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|27.3|||<|0.001|TWO_SIDED|95.0|14.5|40.1|||Chi-squared|||Response on Day 240||40.1|14.5|<0.001
91755076|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.7||||0.384|TWO_SIDED|95.0|-7.1|18.4|||Chi-squared|||Response on Day 240||18.4|-7.1|0.384
91755077|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|29.0|||<|0.001|TWO_SIDED|95.0|16.2|41.8|||Chi-squared|||Response on Day 300||41.8|16.2|<0.001
91755078|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.6||||0.476|TWO_SIDED|95.0|-8.0|17.2|||Chi-squared|||Response on Day 300||17.2|-8.0|0.476
91755079|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|26.5|||<|0.001|TWO_SIDED|95.0|13.7|39.3|||Chi-squared|||Response on Day 360||39.3|13.7|<0.001
91755080|NCT00162266|183403307|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.8||||0.377|TWO_SIDED|95.0|-7.0|18.6|||Chi-squared|||Response on Day 360||18.6|-7.0|0.377
91755081|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-0.8||||0.679|TWO_SIDED|95.0|-4.5|2.9|||Chi-squared|||Response on Day 15||2.9|-4.5|0.679
91755082|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.5||||0.101|TWO_SIDED|95.0|-5.5|0.5|||Chi-squared|||Response on Day 15||0.5|-5.5|0.101
91755083|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.039|TWO_SIDED|95.0|0.4|15.7|||Chi-squared|||Response on Day 30||15.7|0.4|0.039
91755084|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.1||||0.474|TWO_SIDED|95.0|-7.7|3.6|||Chi-squared|||Response on Day 30||3.6|-7.7|0.474
91755085|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.192|TWO_SIDED|95.0|-3.3|16.5|||Chi-squared|||Response on Day 60||16.5|-3.3|0.192
91755086|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.8||||0.702|TWO_SIDED|95.0|-11.0|7.4|||Chi-squared|||Response on Day 60||7.4|-11.0|0.702
91755087|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.7||||0.02|TWO_SIDED|95.0|1.8|21.7|||Chi-squared|||Response on Day 90||21.7|1.8|0.02
91508839|NCT02504372|182889726|OTHER||Hazard Ratio (HR)|0.83||||0.13499|TWO_SIDED|95.0|0.59|1.16|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||1.16|0.59|0.13499
91508840|NCT02504372|182889727|OTHER||Hazard Ratio (HR)|0.78||||0.01327|TWO_SIDED|95.0|0.62|0.97|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.97|0.62|0.01327
91755088|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.5||||0.339|TWO_SIDED|95.0|-4.8|13.8|||Chi-squared|||Response on Day 90||13.8|-4.8|0.339
91755089|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|17.9||||0.001|TWO_SIDED|95.0|7.0|28.9|||Chi-squared|||Response on Day 120||28.9|7.0|0.001
91755090|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.0||||0.682|TWO_SIDED|95.0|-7.6|11.7|||Chi-squared|||Response on Day 120||11.7|-7.6|0.682
91755091|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|20.6|||<|0.001|TWO_SIDED|95.0|9.3|31.8|||Chi-squared|||Response on Day 150||31.8|9.3|<0.001
91755092|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|1.2||||0.813|TWO_SIDED|95.0|-8.6|10.9|||Chi-squared|||Response on Day 150||10.9|-8.6|0.813
91755093|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.8|||<|0.001|TWO_SIDED|95.0|13.8|35.7|||Chi-squared|||Response on Day 180||35.7|13.8|<0.001
91755094|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.1||||0.027|TWO_SIDED|95.0|1.2|20.9|||Chi-squared|||Response on Day 180||20.9|1.2|0.027
91755095|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|15.5||||0.008|TWO_SIDED|95.0|4.0|27.0|||Chi-squared|||Response on Day 240||27.0|4.0|0.008
91755096|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|0.8||||0.885|TWO_SIDED|95.0|-9.8|11.4|||Chi-squared|||Response on Day 240||11.4|-9.8|0.885
91755097|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.0|||<|0.001|TWO_SIDED|95.0|12.6|35.4|||Chi-squared|||Response on Day 300||35.4|12.6|<0.001
91755098|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.8||||0.19|TWO_SIDED|95.0|-3.4|16.9|||Chi-squared|||Response on Day 300||16.9|-3.4|0.19
91755099|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.6|||<|0.001|TWO_SIDED|95.0|9.7|33.4|||Chi-squared|||Response on Day 360||33.4|9.7|<0.001
91755100|NCT00162266|183403308|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.7||||0.625|TWO_SIDED|95.0|-8.1|13.5|||Chi-squared|||Response on Day 360||13.5|-8.1|0.625
91755101|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.04||95.0|0.2|6.8|||Chi-squared|||Response on Day 30||6.8|0.2|0.04
91755102|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.9||||0.063|TWO_SIDED|95.0|-0.2|5.9|||Chi-squared|||Response on Day 30||5.9|-0.2|0.063
91755103|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.7||||0.001|TWO_SIDED|95.0|3.5|13.9|||Chi-squared|||Response on Day 60||13.9|3.5|0.001
91755104|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.8||||0.032|TWO_SIDED|95.0|0.3|7.3|||Chi-squared|||Response on Day 60||7.3|0.3|0.032
91755105|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|7.9||||0.005|TWO_SIDED|95.0|2.4|13.3|||Chi-squared|||Response on Day 90||13.3|2.4|0.005
91755106|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.9||||0.07|TWO_SIDED|95.0|-0.3|8.2|||Chi-squared|||Response on Day 90||8.2|-0.3|0.07
91755107|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|9.7||||0.007|TWO_SIDED|95.0|2.7|16.7|||Chi-squared|||Response on Day 120||16.7|2.7|0.007
91755108|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395||95.0|-3.1|7.8|||Chi-squared|||||7.8|-3.1|0.395
91755109|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|10.6||||0.004|TWO_SIDED|95.0|3.4|17.7|||Chi-squared|||Response on Day 150||17.7|3.4|0.004
91755110|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395|TWO_SIDED|95.0|-3.1|7.8|||Chi-squared|||Response on Day 150||7.8|-3.1|0.395
91755111|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.2|||Chi-squared|||Response on Day 180||22.2|7.5|<0.001
91755112|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.8||||0.005|TWO_SIDED|95.0|2.7|14.9|||Chi-squared|||Response on Day 180||14.9|2.7|0.005
91755113|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||Chi-squared|||Response on Day 240||21.4|5.0|0.002
91755114|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.292|TWO_SIDED|95.0|-3.0|10.1|||Chi-squared|||Response on Day 240||10.1|-3.0|0.292
91755115|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.4|29.5|||Chi-squared|||Response on Day 300||29.5|12.4|<0.001
91755116|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.014|TWO_SIDED|95.0|1.6|14.3|||Chi-squared|||Response on Day 300||14.3|1.6|0.014
91755117|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.3||||0.003|TWO_SIDED|95.0|4.4|22.2|||Chi-squared|||Response on Day 360||22.2|4.4|0.003
91755118|NCT00162266|183403309|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.8||||0.227|TWO_SIDED|95.0|-3.0|12.6|||Chi-squared|||Response on Day 360||12.6|-3.0|0.227
91755119|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.2676|TWO_SIDED|95.0|-1.56|5.61|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||5.61|-1.56|0.2676
91755120|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0418|TWO_SIDED|95.0|-7.46|-0.14|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||-0.14|-7.46|0.0418
91508841|NCT02504372|182889734|OTHER||Hazard Ratio (HR)|0.76||||0.00143|TWO_SIDED|95.0|0.63|0.91|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.91|0.63|0.00143
91508842|NCT00433654|182889735|SUPERIORITY_OR_OTHER_LEGACY||Percentage|0.0|||<|0.001|ONE_SIDED|95.0||1.7|||exact test of binomial proportions|||Null hypothesis: rate \> 10%||1.7||<0.001
91508843|NCT00433654|182889736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.0||||||95.0||||P-value and confidence interval could not be calculated because both groups were 100% successful.|Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||
91755121|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.25||||0.0061|TWO_SIDED|95.0|2.08|12.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||12.41|2.08|0.0061
91755122|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.6713|TWO_SIDED|95.0|-6.45|4.16||ANOVA model: AUC = treatment|ANOVA||Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||4.16|-6.45|0.6713
91755123|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.75||||0.0002|TWO_SIDED|95.0|5.67|17.84|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||17.84|5.67|0.0002
91755124|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.8495|TWO_SIDED|95.0|-5.62|6.82|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||6.82|-5.62|0.8495
91755125|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1||||0.0003|TWO_SIDED|95.0|5.63|18.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||18.56|5.63|0.0003
91755126|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0003|TWO_SIDED|95.0|-2.44|10.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||10.81|-2.44|0.0003
91755127|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.54||||0.0001|TWO_SIDED|95.0|7.28|21.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||21.81|7.28|0.0001
91755128|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.3141|TWO_SIDED|95.0|-3.43|10.64|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||10.64|-3.43|0.3141
91755129|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96||||0.0001|TWO_SIDED|95.0|8.49|25.43|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||25.43|8.49|0.0001
91755130|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.32||||0.3552|TWO_SIDED|95.0|-3.73|10.37|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||10.37|-3.73|0.3552
91755131|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.36||||0.0001|TWO_SIDED|95.0|10.19|30.54|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||30.54|10.19|0.0001
91755132|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38||||0.0451|TWO_SIDED|95.0|0.16|14.6|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||14.60|0.16|0.0451
91755133|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.63||||0.0001|TWO_SIDED|95.0|8.83|26.44|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||26.44|8.83|0.0001
91755134|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78||||0.4669|TWO_SIDED|95.0|-4.73|10.28|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||10.28|-4.73|0.4669
91755135|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.0001|TWO_SIDED|95.0|10.51|31.48|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||31.48|10.51|0.0001
91755136|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13||||3.13|TWO_SIDED|95.0|-4.15|10.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||10.41|-4.15|3.13
91755137|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38||||0.0001|TWO_SIDED|95.0|10.2|30.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||30.56|10.20|0.0001
91755138|NCT00162266|183403310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.06||||0.2989|TWO_SIDED|95.0|-3.61|11.72|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||11.72|-3.61|0.2989
91755139|NCT00162266|183403311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2132.63||||0.0001|TWO_SIDED|95.0|1067.32|3197.94||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||3197.94|1067.32|0.0001
91508844|NCT00433654|182889737|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.5|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
91755140|NCT00162266|183403311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|353.47||||0.4393|TWO_SIDED|95.0|-544.46|1251.41||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||1251.41|-544.46|0.4393
91508845|NCT00433654|182889738|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|1.9|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
91755141|NCT00162266|183403311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5641.6||||0.0001|TWO_SIDED|95.0|2823.46|8459.74||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||8459.74|2823.46|0.0001
91508846|NCT00433654|182889739|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|2.1|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
91508847|NCT00433654|182889740|SUPERIORITY_OR_OTHER_LEGACY||Percentage|8.3|||<|0.001|ONE_SIDED|95.0||10.7|||exact test of binomial proportions|||Null hypothesis: Percentage of subjects with complication \> 20%||10.7||<0.001
91508848|NCT00079274|182889783|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.15|TWO_SIDED|95.0|0.92|1.68|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.68|0.92|0.15
91755142|NCT00162266|183403311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1054.38||||0.3029|TWO_SIDED|95.0|-955.59|3064.35||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||3064.35|-955.59|0.3029
91755143|NCT00162266|183403315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.66||||0.0003|TWO_SIDED|95.0|12.67|42.66|||ANCOVA|ANCOVA: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||42.66|12.67|0.0003
91755144|NCT00162266|183403315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68||||0.3253|TWO_SIDED|95.0|||||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||||0.3253
91508849|NCT00079274|182889784|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.25|TWO_SIDED|95.0|0.85|1.92|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.92|0.85|0.25
91508850|NCT00079274|182889785|SUPERIORITY||||||<|0.001|||||||Chi-squared|two-sided chi-squared test||||||<0.001
91755145|NCT00162266|183403315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.24||||0.0001|TWO_SIDED|95.0|16.14|48.33|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||48.33|16.14|0.0001
91755146|NCT00162266|183403315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48||||0.0869|TWO_SIDED|95.0|-1.82|26.78|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||26.78|-1.82|0.0869
91755147|NCT03449433|183403438|SUPERIORITY||Ratio of LS Means|1.04|||||TWO_SIDED|95.0|0.985|1.1||||||||1.10|0.985|
91755148|NCT02100475|183403453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.427|TWO_SIDED|95.0|-1.05|0.46|||ANCOVA|||The response and change from baseline in the response after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) method with treatment and baseline IDegLira dose strata as fixed factors and baseline response as a covariate. Missing data were imputed using LOCF.||0.46|-1.05|0.427
91755149|NCT03268941|183403460|OTHER||Least Square (LS) Mean Difference|7.38|||<|0.001|TWO_SIDED|95.0|4.03|13.52||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||13.52|4.03|<0.001
91755150|NCT03268941|183403460|OTHER||LS Mean Difference|11.24|||<|0.001|TWO_SIDED|95.0|5.91|21.41||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||21.41|5.91|<0.001
91755151|NCT03268941|183403460|OTHER||LS Mean Difference|12.8|||<|0.001|TWO_SIDED|95.0|6.94|23.59||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||23.59|6.94|<0.001
91755152|NCT03268941|183403461|OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|14.648||0.599|TWO_SIDED|95.0|-21.89|37.41||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.41|-21.89|0.599
91755153|NCT03268941|183403461|OTHER||LS Mean Difference|6.28|STANDARD_ERROR_OF_MEAN|15.469||0.687|TWO_SIDED|95.0|-25.04|37.59||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.59|-25.04|0.687
91755154|NCT03268941|183403461|OTHER||LS Mean Difference|8.05|STANDARD_ERROR_OF_MEAN|15.45||0.605|TWO_SIDED|95.0|-23.22|39.33||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||39.33|-23.22|0.605
91508851|NCT00079274|182889786|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided chi-squared test||||||<0.001
91755155|NCT03268941|183403462|OTHER||LS Mean Difference|7.56|STANDARD_ERROR_OF_MEAN|11.708||0.522|TWO_SIDED|95.0|-16.06|31.19||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||31.19|-16.06|0.522
91755156|NCT03268941|183403462|OTHER||LS Mean Difference|12.92|STANDARD_ERROR_OF_MEAN|12.143||0.293|TWO_SIDED|95.0|-11.58|37.43||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||37.43|-11.58|0.293
91755157|NCT03268941|183403462|OTHER||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|11.654||0.551|TWO_SIDED|95.0|-16.52|30.52||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||30.52|-16.52|0.551
91755158|NCT03268941|183403463|OTHER||Hodges-Lehmann Estimate of Median Diff|-18.14||||0.274|TWO_SIDED|95.0|-307.58|13.56||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||13.56|-307.58|0.274
91755159|NCT03268941|183403463|OTHER||Hodges-Lehmann Estimate of Median Diff|-26.95||||0.481|TWO_SIDED|95.0|-229.73|530.49||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||530.49|-229.73|0.481
91755160|NCT03268941|183403463|OTHER||Hodges-Lehmann Estimate of Median Diff|-24.49||||0.382|TWO_SIDED|95.0|-225.87|98.91||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.||98.91|-225.87|0.382
91755161|NCT03878758|183403473|SUPERIORITY|The average difference in incidence of needle bending with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.39||||0.591|TWO_SIDED|95.0|-1.82|1.04|||Fisher Exact|||||1.04|-1.82|0.591
91755162|NCT03878758|183403473|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.13||||0.931|TWO_SIDED|95.0|-2.8|3.06|||Fisher Exact|||||3.06|-2.8|0.931
91755163|NCT03878758|183403473|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.42||||0.723|TWO_SIDED|95.0|-1.91|2.75|||Fisher Exact|||||2.75|-1.91|0.723
91508852|NCT01147653|182889788|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.72|TWO_SIDED|95.0|-2.6|3.7|||t-test, 2 sided|||H0: The true mean 1-year change in GMFM-66 is the same on Autologous Umbilical Cord Blood and Placebo||3.7|-2.6|0.72
91508853|NCT01147653|182889789|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91508854|NCT01147653|182889790|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.473
91755164|NCT03878758|183403474|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-5.7|||<|0.001|TWO_SIDED|95.0|-9.0|-3.5|||Fisher Exact|||||-3.5|-9.0|<0.001
91755165|NCT03878758|183403474|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-14.09||||0.026|TWO_SIDED|95.0|-26.49|-1.69||Although a site difference was detected - all sites combined p-value was generated,|Fisher Exact|||||-1.69|-26.49|0.026
91755166|NCT03878758|183403474|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs.Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.2||||0.644|TWO_SIDED|95.0|-1.9|0.6|||Fisher Exact|||||0.6|-1.9|0.644
91755167|NCT03878758|183403475|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.8|||||TWO_SIDED|95.0|0.62|0.98||||||||0.98|0.62|
91755168|NCT03878758|183403475|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|1.0|||||TWO_SIDED|95.0|0.8|1.16||||||||1.16|0.8|
91755169|NCT03878758|183403475|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.3|||||TWO_SIDED|95.0|0.13|0.49||||||||0.49|0.13|
91755170|NCT03878758|183403476|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.192|||<|0.001|ONE_SIDED|95.0||-0.141|||Mixed Models Analysis|||BD Nano Pro vs Artsana 34G||-0.141||<0.001
91508855|NCT01147653|182889790|SUPERIORITY|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Bodily Pain/Discomfort change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.377
91508856|NCT01147653|182889790|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Family Cohesion change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.844
91508857|NCT01147653|182889790|SUPERIORITY|||||||0.322|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.322
91508858|NCT01147653|182889790|SUPERIORITY|||||||0.927|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Health Perceptions change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.927
91755171|NCT03878758|183403476|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.122||||0.104|ONE_SIDED|95.0||0.016|||Mixed Models Analysis|||BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.||0.016||0.104
91755172|NCT03878758|183403476|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary. The upper bound of the confidence interval was compared to 0.|Mean Difference (Net)|-0.068||||0.003|ONE_SIDED|95.0||-0.017|||Mixed Models Analysis|||BD NANO vs Comfort EZ 33G||-0.017||0.003
91755173|NCT03878758|183403477|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
91755174|NCT03878758|183403477|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
91755175|NCT03878758|183403477|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
91759762|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.57|||||TWO_SIDED|95.0|-17.53|18.68|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||18.68|-17.53|
91755176|NCT01769196|183403479|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.13||||0.329|TWO_SIDED|95.0|0.88|1.45|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||1.45|0.88|0.329
91508859|NCT01147653|182889790|SUPERIORITY|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Global Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.199
91508860|NCT01147653|182889790|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Growth and Development change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.294
91508861|NCT01147653|182889790|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Overall Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.726
91508862|NCT01147653|182889790|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Emotional change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.315
91508863|NCT01147653|182889790|SUPERIORITY|||||||0.396|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Time change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.396
91508864|NCT01147653|182889790|SUPERIORITY|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Physical Abilities change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.381
91508865|NCT01147653|182889790|SUPERIORITY|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Temperament and Moods change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.869
91508866|NCT01147653|182889791|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||H0: The 12 month Access to Services change score is identically distributed in patients assigned Autologous Cord Blood Reinfusion First and Placebo First.||||0.055
91508867|NCT01147653|182889791|SUPERIORITY|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Emotional Well Being and Self Esteem change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.121
91508868|NCT01147653|182889791|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Family Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.647
91508869|NCT01147653|182889791|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Functioning change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.170
91508870|NCT01147653|182889791|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Pain and Impact of Disability change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.410
91508871|NCT01147653|182889791|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Participation and Physical Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.200
91508872|NCT01147653|182889791|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Social wellbeing and acceptance change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.225
91508873|NCT01147653|182889794|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.290
91508874|NCT01147653|182889797|SUPERIORITY|||||||0.697|||||||t-test, 2 sided|||||||0.697
91508875|NCT01147653|182889798|SUPERIORITY|||||||0.912|||||||t-test, 2 sided|||||||0.912
91508876|NCT01147653|182889799|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
91508877|NCT01147653|182889800|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
91508878|NCT01147653|182889801|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
91508879|NCT01147653|182889802|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
91508880|NCT01147653|182889803|SUPERIORITY|||||||0.099|||||||t-test, 2 sided|||||||0.099
91508881|NCT01147653|182889804|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
91508882|NCT01147653|182889805|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
91508883|NCT01147653|182889806|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
91532907|NCT01341080|182942810|OTHER||Cohen's d|0.81||||0.05|TWO_SIDED|95.0|-0.4|1.4|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Mini Mental State Exam (MMSE) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the MMSE scores. Scale score was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.40|-0.40|0.05
91508884|NCT01147653|182889807|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.310
91508885|NCT01147653|182889809|SUPERIORITY|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of Modified Ashworth Scale scores is the same at 1-year post-infusion with autologous cord blood and placebo.||||0.233
91508886|NCT01147653|182889813|SUPERIORITY|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
91532908|NCT00755755|182942840|SUPERIORITY_OR_OTHER||Difference in proportions|72.7|||<|0.001|TWO_SIDED|95.0|55.1|83.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||83.2|55.1|<0.001
91508887|NCT01147653|182889814|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low and High doses of autologous umbilical cord blood.||||0.05
91508888|NCT01147653|182889814|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with High doses of autologous umbilical cord blood and Placebo.||||0.15
91508889|NCT01147653|182889814|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low doses of autologous umbilical cord blood and placebo.||||0.21
91532909|NCT00755755|182942840|SUPERIORITY_OR_OTHER||Difference in proportions|73.7|||<|0.001|TWO_SIDED|95.0|56.2|84.0||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||84.0|56.2|<0.001
91508890|NCT01147653|182889815|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of differences between observed and expected GMFM-66 change scores at 1-year post-infusion is the same for patients receiving Low and High doses of autologous umbilical cord blood.||||<0.01
91755177|NCT01769196|183403480|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.03||||0.851|TWO_SIDED|95.0|0.74|1.43|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||1.43|0.74|0.851
91508891|NCT01147653|182889816|SUPERIORITY|H0: The population distribution of the Peabody Gross Motor Quotient change score 1 year post-infusion with autologous umbilical cord blood is the same in patients receiving a Low infused dose and a High infused dose.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91755178|NCT01769196|183403481|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.2||||0.475|TWO_SIDED|95.0|0.72|2.0|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.00|0.72|0.475
91755179|NCT01769196|183403482|OTHER||Hazard Ratio (HR)|1.2||||0.602|TWO_SIDED|95.0|0.61|2.37|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||2.37|0.61|0.602
91755180|NCT01769196|183403483|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.99||||0.988|TWO_SIDED|95.0|0.43|2.28|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.28|0.43|0.988
91755181|NCT01769196|183403484|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.95||||0.925|TWO_SIDED|95.0|0.3|2.99|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.99|0.30|0.925
91755182|NCT00321464|183403513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82|||<|0.0001||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|<0.0001
91755183|NCT00321464|183403514|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.01||95.0|0.71|0.95||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|0.010
91755184|NCT00321464|183403515|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.77||||0.001||95.0|0.66|0.89||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Anderson-Gill model||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.89|0.66|0.001
91755185|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||ANOVA|||The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.||1.07|0.74|
91755186|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.84|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.||1.23|0.84|
91508892|NCT01147653|182889817|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.04|TWO_SIDED|95.0|0.01|0.38|||Wilcoxon (Mann-Whitney)|||H0: The true mean 1-year change in normalized whole brain connectivity is the same in patients infused with Low and High doses of autologous umbilical cord blood.||0.38|0.01|0.04
91508893|NCT00280566|182889818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Log Rank|alpha = 0.05 level of significance||Equality of Survival Curves across the treatment groups.||||0.0104
91759763|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.81|||||TWO_SIDED|95.0|-22.07|12.45|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||12.45|-22.07|
91759764|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
91759765|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.89|||||TWO_SIDED|95.0|-11.21|15.0|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||15.00|-11.21|
91755187|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.||1.15|0.83|
91755188|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.69|1.26|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.||1.26|0.69|
91759766|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
91508894|NCT00280566|182889819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||Log Rank|No adjustment made for multiple comparisons||alpha = 0.05 level of significance||||0.0047
91508895|NCT00280566|182889820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205||||||No adjustment made for multiple comparisons|Log Rank|||alpha = 0.05 level of significance||||0.0205
91508896|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.55||0.1247|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1247
91508897|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7515|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7515
91508898|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.62||0.3074|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3074
91508899|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.0758|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0758
91508900|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.82||0.0162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0162
91508901|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|0.83||0.0003|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0003
91508902|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.98||0.0242|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0242
91508903|NCT00280566|182889821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.71||0.0161|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0161
91508904|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0088|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0088
91508905|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3677|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3677
91508906|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0734|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0734
91532910|NCT00755755|182942841|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-22.6||||0.002|TWO_SIDED|95.0|-36.1|-8.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-8.2|-36.1|0.002
91532911|NCT00755755|182942841|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.2||||0.006|TWO_SIDED|95.0|-33.0|-5.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-5.2|-33.0|0.006
91532912|NCT00811187|182942850|SUPERIORITY|\[Not Specified\]|Mean Difference (Net)|-2.03|||<|0.001|TWO_SIDED||||||Regression, Linear||Treatment pain difference= Lidocaine (0.97) - Placebo (3.00).|A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.||||<.001
91532913|NCT00083174|182942937|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35||||0.002|TWO_SIDED|95.0|0.18|0.7|||Log Rank|||The null hypothesis was no difference between two groups. The sample size estimate was based on an assumption of annual invasive breast cancer rate of 0.60% in the placebo group and 0.21% in exemestane group, a relative reduction of 65% with exemestane. To detect this with a two-sided 5% level and 90% power, a total of 38 cases of invasive breast cancer were required, projected to occur when 4560 women were randomly assigned in a 3-year period and then followed for an additional 1.2 years.||0.70|0.18|0.002
91532914|NCT00083174|182942938|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.27|0.79|||Log Rank|||||0.79|0.27|0.004
91532915|NCT00083174|182942939|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.36||||0.07|TWO_SIDED|95.0|0.11|1.12|||Log Rank|||||1.12|0.11|0.07
91755189|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.82|1.13|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.||1.13|0.82|
91532916|NCT02444143|182942944|OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
91755190|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.78|1.16|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.||1.16|0.78|
91755191|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.||1.21|0.85|
91532917|NCT02444143|182942945|OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
91755192|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.|GMC ratio|1.61|||||TWO_SIDED|95.0|1.28|2.03|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.||2.03|1.28|
91532918|NCT03582137|182942946|SUPERIORITY||Mean Difference (Net)|-1.8049||||0.3785|TWO_SIDED|95.0|-5.8839|2.2741|||Mixed Models Analysis|||||2.2741|-5.8839|0.3785
91532919|NCT03582137|182942950|SUPERIORITY||Mean Difference (Net)|-4.4254||||0.2712|TWO_SIDED|95.0|-12.4018|3.551|||Mixed Models Analysis|||||3.5510|-12.4018|0.2712
91532920|NCT03582137|182942951|SUPERIORITY||Mean Difference (Net)|0.3133||||0.8974|TWO_SIDED|95.0|-4.5414|5.168|||Mixed Models Analysis|||||5.1680|-4.5414|0.8974
91532921|NCT03582137|182942952|SUPERIORITY||Mean Difference (Net)|0.1505||||0.4643|TWO_SIDED|95.0|-0.2882|0.5892|||Mixed Models Analysis|||||0.5892|-0.2882|0.4643
91532922|NCT03582137|182942953|SUPERIORITY||Mean Difference (Net)|-0.1188||||0.6245|TWO_SIDED|95.0|-0.6019|0.3644|||Mixed Models Analysis|||||0.3644|-0.6019|0.6245
91532923|NCT03582137|182942959|SUPERIORITY||Mean Difference (Net)|-0.3341||||0.5921|TWO_SIDED|95.0|-1.5749|0.9068|||Mixed Models Analysis|||||0.9068|-1.5749|0.5921
91532924|NCT03582137|182942960|SUPERIORITY||Mean Difference (Net)|1.9352||||0.1016|TWO_SIDED|95.0|-0.4372|4.3076|||Mixed Models Analysis|||||4.3076|-0.4372|0.1016
91532925|NCT03582137|182942961|SUPERIORITY||Mean Difference (Net)|19.686||||0.0661|TWO_SIDED|95.0|-1.3733|40.7452|||Mixed Models Analysis|||||40.7452|-1.3733|0.0661
91532926|NCT03582137|182942962|SUPERIORITY||Mean Difference (Net)|-3.2214||||0.088|TWO_SIDED|95.0|-6.9381|0.4953|||Mixed Models Analysis|||||0.4953|-6.9381|0.0880
91532927|NCT03582137|182942963|SUPERIORITY||Mean Difference (Net)|-4.9836||||0.2827|TWO_SIDED|95.0|-14.2093|4.2421|||Mixed Models Analysis|||||4.2421|-14.2093|0.2827
91532928|NCT03582137|182942964|SUPERIORITY||Mean Difference (Net)|0.576||||0.7703|TWO_SIDED|95.0|-3.3697|4.5216|||Mixed Models Analysis|||||4.5216|-3.3697|0.7703
91532929|NCT03582137|182942965|SUPERIORITY||Mean Difference (Net)|-0.8834||||0.1874|TWO_SIDED|95.0|-2.2172|0.4504|||Mixed Models Analysis|||||0.4504|-2.2172|0.1874
91532930|NCT03582137|182942968|SUPERIORITY||Mean Difference (Net)|1.2993||||0.1646|TWO_SIDED|95.0|-0.5533|3.1519|||Mixed Models Analysis|||||3.1519|-0.5533|0.1646
91532931|NCT03582137|182942969|SUPERIORITY||Mean Difference (Net)|-1.7519||||0.1093|TWO_SIDED|95.0|-3.9082|0.4045|||Mixed Models Analysis|||||0.4045|-3.9082|0.1093
91532932|NCT03582137|182942970|SUPERIORITY||Mean Difference (Net)|1.3532||||0.1819|TWO_SIDED|95.0|-0.6511|3.3576|||Mixed Models Analysis|||||3.3576|-0.6511|0.1819
91532933|NCT03582137|182942971|SUPERIORITY||Mean Difference (Net)|0.9667||||0.2282|TWO_SIDED|95.0|-0.6287|2.5621|||Mixed Models Analysis|||||2.5621|-0.6287|0.2282
91532934|NCT03582137|182942972|SUPERIORITY||Mean Difference (Net)|-0.2614||||0.6167|TWO_SIDED|95.0|-1.3002|0.7775|||Mixed Models Analysis|||||0.7775|-1.3002|0.6167
91532935|NCT03582137|182942973|SUPERIORITY||Mean Difference (Net)|0.3067||||0.8378|TWO_SIDED|95.0|-2.6765|3.2899|||Mixed Models Analysis|||||3.2899|-2.6765|0.8378
91755193|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.|GMC ratio|1.06|||||TWO_SIDED|95.0|0.82|1.36|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.||1.36|0.82|
91759767|NCT01393639|183411979|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.35|||||TWO_SIDED|95.0|-14.38|9.66|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.66|-14.38|
91532936|NCT03582137|182942975|SUPERIORITY||Mean Difference (Net)|0.3237||||0.2103|TWO_SIDED|95.0|-0.188|0.8353|||Mixed Models Analysis|||||0.8353|-0.1880|0.2103
91532937|NCT03582137|182942976|SUPERIORITY||Mean Difference (Net)|-0.504||||0.7197|TWO_SIDED|95.0|-3.3015|2.2934|||Mixed Models Analysis|||||2.2934|-3.3015|0.7197
91532938|NCT03582137|182942977|SUPERIORITY||Mean Difference (Net)|2.6158||||0.0686|TWO_SIDED|95.0|-0.2058|5.4373|||Mixed Models Analysis|||||5.4373|-0.2058|0.0686
91532939|NCT03582137|182942978|SUPERIORITY||Mean Difference (Net)|2.7891||||0.2339|TWO_SIDED|95.0|-1.8523|7.4304|||Mixed Models Analysis|||||7.4304|-1.8523|0.2339
91532940|NCT03582137|182942979|SUPERIORITY||Mean Difference (Net)|0.9536||||0.7557|TWO_SIDED|95.0|-5.1655|7.0727|||Mixed Models Analysis|||||7.0727|-5.1655|0.7557
91532941|NCT03582137|182942981|SUPERIORITY||Mean Difference (Net)|0.05126||||0.915|TWO_SIDED|95.0|-0.9086|1.0111|||Mixed Models Analysis|||||1.0111|-0.9086|0.9150
91532942|NCT03582137|182942982|SUPERIORITY||Mean Difference (Net)|-0.6699||||0.6164|TWO_SIDED|95.0|-3.3316|1.9918|||Mixed Models Analysis|||||1.9918|-3.3316|0.6164
91532943|NCT03582137|182942983|SUPERIORITY||Mean Difference (Net)|-0.1358||||0.755|TWO_SIDED|95.0|-1.0028|0.7312|||Mixed Models Analysis|||||0.7312|-1.0028|0.7550
91532944|NCT03582137|182942984|SUPERIORITY||Mean Difference (Net)|-0.09605||||0.9016|TWO_SIDED|95.0|-1.6449|1.4528|||Mixed Models Analysis|||||1.4528|-1.6449|0.9016
91532945|NCT03582137|182942985|SUPERIORITY||Mean Difference (Net)|-0.3217||||0.9219|TWO_SIDED|95.0|-6.8584|6.2151|||Mixed Models Analysis|||||6.2151|-6.8584|0.9219
91532946|NCT03582137|182942986|SUPERIORITY||Mean Difference (Net)|0.02897||||0.3178|TWO_SIDED|95.0|-0.02857|0.08651|||Mixed Models Analysis|||||0.08651|-0.02857|0.3178
91532947|NCT03582137|182942991|SUPERIORITY||Mean Difference (Net)|0.2288||||0.7693|TWO_SIDED|95.0|-1.325|1.7825|||Mixed Models Analysis|||||1.7825|-1.3250|0.7693
91532948|NCT03582137|182942992|SUPERIORITY||Mean Difference (Net)|-0.8121||||0.5285|TWO_SIDED|95.0|-3.3743|1.7501|||Mixed Models Analysis|||||1.7501|-3.3743|0.5285
91532949|NCT03582137|182942993|SUPERIORITY||Mean Difference (Net)|-0.02525||||0.9463|TWO_SIDED|95.0|-0.7717|0.7212|||Mixed Models Analysis|||||0.7212|-0.7717|0.9463
91532950|NCT03582137|182942994|SUPERIORITY||Mean Difference (Net)|-0.3042||||0.4362|TWO_SIDED|95.0|-1.0817|0.4732|||Mixed Models Analysis|||||0.4732|-1.0817|0.4362
91532951|NCT03582137|182942995|SUPERIORITY||Mean Difference (Net)|-0.06489||||0.9327|TWO_SIDED|95.0|-1.5957|1.4659|||Mixed Models Analysis|||||1.4659|-1.5957|0.9327
91532952|NCT03582137|182942998|SUPERIORITY||Mean Difference (Net)|-0.2763||||0.4401|TWO_SIDED|95.0|-0.988|0.4354|||Mixed Models Analysis|||||0.4354|-0.9880|0.4401
91532953|NCT03582137|182942999|SUPERIORITY||Mean Difference (Net)|-0.8319||||0.8085|TWO_SIDED|95.0|-7.6835|6.0197|||Mixed Models Analysis|||||6.0197|-7.6835|0.8085
91532954|NCT03582137|182943001|SUPERIORITY||Mean Difference (Net)|0.02673||||0.9674|TWO_SIDED|95.0|-1.2757|1.3292|||Mixed Models Analysis|||||1.3292|-1.2757|0.9674
91532955|NCT03582137|182943003|SUPERIORITY||Mean Difference (Net)|-46.92||||0.1128|TWO_SIDED|95.0|-105.51|11.68|||Mixed Models Analysis|||||11.68|-105.51|0.1128
91532956|NCT00558753|182943019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91532957|NCT00558753|182943020|SUPERIORITY_OR_OTHER||Independence: Chi-squared|10.3||||0.0013||95.0|||||Chi-squared|||For 3 month followup on incidence of neuropathic pain.||||0.0013
91532958|NCT00558753|182943020|SUPERIORITY_OR_OTHER||Independence: Chi-squared|6.05||||0.0139|||||||Chi-squared|||For 6 month followup on incidence of neuropathic pain.||||0.0139
91532959|NCT00558753|182943021|SUPERIORITY_OR_OTHER||Slope|-4.2||||0.0133||95.0||||Test of condition(Placebo v Pregabalin) main effect.|Mixed Models Analysis|Mixed model with main effects and time by condition interaction.||Mixed model test of condition (Placebo v Pregabalin) main effect.||||0.0133
91759768|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13|||||TWO_SIDED|95.0|-4.19|-0.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.07|-4.19|
91759769|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-5.63|-1.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.57|-5.63|
91759770|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-5.06|-0.97||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.97|-5.06|
91755194|NCT00652951|183403524|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.|GMC ratio|0.92|||||TWO_SIDED|95.0|0.7|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.||1.23|0.7|
91755195|NCT00652951|183403525|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.|GMC ratio|0.91|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.||1.06|0.77|
91755196|NCT02100969|183403569|SUPERIORITY||"proportion of successes"|0.864||||0.0179|TWO_SIDED|95.0|0.72|1.0||No adjustment is required as we are not doing multiple comparisons for the primary outcome analyses.|One sample Z test of proportions||One sample Z test of proportions is used. Method of handling missing data (as per protocol) is Last Observation Carried Forward (LOCF). Only 2 participants had missing values and in our case the LOCF results reflect a 'best-case' scenario.|"Sample size/power calculations are mentioned in the study protocol.~The study hypotheses are as follows:~H0: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase \> 0.65"||1.000|0.720|0.0179
91755197|NCT02100969|183403570|SUPERIORITY||Median Difference (Net)|0.0||||0.113|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed rank test statistic is 44.50.|||||0.113
91755198|NCT02100969|183403571|SUPERIORITY||Median Difference (Net)|6.0||||0.612|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.612
91755199|NCT02100969|183403572|SUPERIORITY||Median Difference (Net)|2.0||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed-rank test statistic is 53.|||||0.047
91755200|NCT02100969|183403573|SUPERIORITY||Median Difference (Net)|5.6||||0.901|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.901
91755201|NCT02100969|183403574|SUPERIORITY||Median Difference (Net)|4.2||||0.51|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.510
91755202|NCT02100969|183403575|SUPERIORITY||Median Difference (Net)|8.3||||0.289|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.289
91755203|NCT02100969|183403576|SUPERIORITY||Median Difference (Net)|715.0||||0.0028|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.0028
91755204|NCT04473664|183403590|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|95.1|||||TWO_SIDED|90.0|77.1|117.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||117|77.1|
91755205|NCT04473664|183403592|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|59.5|201.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||201|59.5|
91755206|NCT04473664|183403592|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|57.9|207.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||207|57.9|
91755207|NCT04473664|183403596|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|74.4|||||TWO_SIDED|90.0|32.0|173.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||173|32.0|
91759771|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-5.73|-1.68||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-5.73|
91759772|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.93|||||TWO_SIDED|95.0|-3.97|0.12||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.12|-3.97|
91759773|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.43|||||TWO_SIDED|95.0|-5.46|-1.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.39|-5.46|
91755208|NCT04473664|183403598|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|62.5|||||TWO_SIDED|90.0|35.3|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for AC886.||111|35.3|
91755209|NCT04473664|183403598|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|69.9|||||TWO_SIDED|90.0|46.8|104.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for AC886.||104|46.8|
91755210|NCT04473664|183403601|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|44.7|||||TWO_SIDED|90.0|18.0|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||111|18.0|
91755211|NCT04473664|183403602|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|16.0|165.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||165|16.0|
91755212|NCT04473664|183403602|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|15.8|168.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||168|15.8|
91755213|NCT02066415|183403617|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.04."|Difference in LS Means|-2.46|||<|0.001|TWO_SIDED|95.0|-3.52|-1.39|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.39|-3.52|<0.001
91755214|NCT02066415|183403617|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.01."|Difference in LS Means|-2.45|||<|0.001|TWO_SIDED|95.0|-3.51|-1.38|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.38|-3.51|<0.001
91755215|NCT02066415|183403618|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.46|3.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.27|1.46|<0.001
91755216|NCT02066415|183403618|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.56|3.51|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.51|1.56|<0.001
91755217|NCT02066415|183403619|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-1.86|||<|0.001|TWO_SIDED|95.0|-2.6|-1.13|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.13|-2.60|<0.001
91508907|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9166|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9166
91508908|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2791|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2791
91508909|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.146|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1460
91508910|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.7301|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7301
91755218|NCT02066415|183403619|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-2.55|||<|0.001|TWO_SIDED|95.0|-3.28|-1.82|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.82|-3.28|<0.001
91508911|NCT00280566|182889822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8162
91755219|NCT02066415|183403620|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-9.54||||0.28|TWO_SIDED|95.0|-26.98|7.9|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||7.90|-26.98|0.28
91755220|NCT02066415|183403620|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-19.31||||0.03|TWO_SIDED|95.0|-36.71|-1.92|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.92|-36.71|0.030
91755221|NCT01116427|183403623|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.87
91755222|NCT01116427|183403624|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups|Wilcoxon (Mann-Whitney)|||||||0.36
91755223|NCT01116427|183403625|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.93
91755224|NCT01116427|183403626|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups|Wilcoxon (Mann-Whitney)|||||||0.68
91755225|NCT01116427|183403627|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED|||||Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups|Wilcoxon (Mann-Whitney)|||||||0.21
91755226|NCT01116427|183403628|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Fisher Exact|||||||0.65
91755227|NCT01116427|183403630|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.13
91755228|NCT01116427|183403631|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.06
91532960|NCT00558753|182943021|SUPERIORITY_OR_OTHER||Interaction Slice F-value|1.04||||0.3097||95.0|||||Mixed Models Analysis|Mixed model test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||Test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||||0.3097
91755229|NCT01116427|183403632|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.07
91755230|NCT01116427|183403633|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.88
91755231|NCT01116427|183403634|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Fisher Exact|||||||0.29
91755232|NCT01116427|183403636|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.67
91755233|NCT03344640|183403679|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.875|TWO_SIDED|90.0|-8.84|7.3|||LS mean|LS mean change from baseline in WORC total percentage score||All Patients at day 99||7.30|-8.84|0.875
91755234|NCT03344640|183403680|SUPERIORITY||Difference and 90% CI versus placebo|3.97||||0.19|TWO_SIDED|90.0|-1.03|8.97|||LS mean|LS mean change from baseline in WORC total percentage score||All patientts at day 15||8.97|-1.03|0.190
91755235|NCT03344640|183403680|SUPERIORITY||Difference and 90% CI versus placebo|3.97|||||TWO_SIDED|90.0|-3.39|9.11|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 29||9.11|-3.39|
91755236|NCT03344640|183403680|SUPERIORITY||Difference and 90% CI versus placebo|0.761||||0.761|TWO_SIDED|90.0|-8.81|6.08|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 57||6.08|-8.81|0.761
91755237|NCT03344640|183403680|SUPERIORITY||Difference and 90% CI versus placebo|0.765||||0.765|TWO_SIDED|90.0|-6.27|9.03|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 85||9.03|-6.27|0.765
91755238|NCT03344640|183403680|SUPERIORITY||Difference and 90% CI versus placebo|0.491||||0.491|TWO_SIDED|90.0|-4.73|11.45|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 127||11.45|-4.73|0.491
91755239|NCT03344640|183403680|SUPERIORITY||Difference and 90% CI versus placebo|2.44||||0.639|TWO_SIDED|90.0|-6.19|11.07|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at end of study||11.07|-6.19|0.639
91508912|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0013
91755240|NCT03344640|183403681|SUPERIORITY||Difference and 90% CI versus Placebo|1.23||||0.735|TWO_SIDED|90.0|-4.81|7.28||Difference and 90% CI versus placebo|LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD Analysis Set) at day 99||7.28|-4.81|0.735
91508913|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.1167|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1167
91532961|NCT00558753|182943021|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.1||||0.0247||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 2-day post surgery time point (Slice)||||0.0247
91532962|NCT00558753|182943021|SUPERIORITY_OR_OTHER||Interaction Slice F-value|3.11||||0.0786||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 3-day post surgery time point (Slice)||||0.0786
91532963|NCT00558753|182943021|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.04||||0.0254||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 30-day post surgery time point (Slice)||||0.0254
91532964|NCT00162942|182943022|SUPERIORITY_OR_OTHER|||||||0.858|||||||Fisher Exact|||||||.858
91532965|NCT00162942|182943024|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Student's t-test|||||||0.813
91508914|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0188|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0188
91532966|NCT00162942|182943025|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
91532967|NCT00162942|182943026|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Student's t-test|||||||0.670
91532968|NCT00162942|182943027|SUPERIORITY_OR_OTHER|||||||0.977||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.977
91532969|NCT00162942|182943028|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.670
91532970|NCT00162942|182943029|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.170
91532971|NCT00162942|182943030|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0773
91532972|NCT00162942|182943031|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.261
91532973|NCT00162942|182943032|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.379
91532974|NCT00162942|182943033|SUPERIORITY_OR_OTHER|||||||0.441||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.441
91532975|NCT00162942|182943034|SUPERIORITY_OR_OTHER|||||||0.759||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.759
91532976|NCT00162942|182943035|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.222
91532977|NCT00162942|182943036|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.256
91532978|NCT00162942|182943037|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.870
91532979|NCT00162942|182943038|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.350
91532980|NCT00162942|182943039|SUPERIORITY_OR_OTHER|||||||0.0632||95.0|||||Fisher Exact|||||||0.0632
91532981|NCT00162942|182943039|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0504
91532982|NCT00162942|182943040|SUPERIORITY_OR_OTHER|||||||0.8265||95.0|||||Fisher Exact|||||||0.8265
91532983|NCT00162942|182943041|SUPERIORITY_OR_OTHER|||||||0.0676||95.0|||||Fisher Exact|||||||0.0676
91532984|NCT00162942|182943041|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0506
91532985|NCT00162942|182943042|SUPERIORITY_OR_OTHER|||||||0.8721||95.0|||||Fisher Exact|||||||0.8721
91532986|NCT00162942|182943043|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||Fisher Exact|||||||0.0289
91532987|NCT00162942|182943044|SUPERIORITY_OR_OTHER|||||||0.8618||95.0|||||Fisher Exact|||||||0.8618
91532988|NCT00410384|182943045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0167|TWO_SIDED|95.0|1.08|2.19||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.19|1.08|0.0167
91532989|NCT00410384|182943045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)|Regression, Logistic|Adjusted for baseline stratification factors.||||1.94|0.95|0.0889
91532990|NCT00410384|182943046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.1323|TWO_SIDED|95.0|0.92|1.87|||Regression, Logistic|Analysis was adjusted for baseline stratification factors.||||1.87|0.92|0.1323
91532991|NCT00410384|182943046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.105|TWO_SIDED|95.0|0.94|1.91|||Regression, Logistic||Analysis was adjusted for baseline stratification factors.|||1.91|0.94|0.1050
91532992|NCT00410384|182943047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0063|TWO_SIDED|95.0|1.15|2.32|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.32|1.15|0.0063
91532993|NCT00410384|182943047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.074|TWO_SIDED|95.0|0.97|1.96|||Regression, Logistic|Adjusted for baseline stratification factors.||||1.96|0.97|0.0740
91755241|NCT03344640|183403681|SUPERIORITY||Difference and 90% CI versus Placebo|1.51||||0.689|TWO_SIDED|90.0|-4.76|7.79|||LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD analysis set) at End of Study||7.79|-4.76|0.689
91508915|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.3413|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3413
91755242|NCT03344640|183403682|SUPERIORITY||Difference and 90% CI vesus placebo|3.5||||0.411|TWO_SIDED|90.0|-3.54|10.54|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at day 99||10.54|-3.54|0.411
91755243|NCT03344640|183403682|SUPERIORITY||Difference and 90% CI versus placebo|1.14||||0.804|TWO_SIDED|90.0|-6.5|8.78|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at End of Study set)||8.78|-6.50|0.804
91755244|NCT03344640|183403683|SUPERIORITY||Difference and 90% CI versus placebo|-1.26||||0.706|TWO_SIDED|90.0|-6.81|4.29|||LS Mean|LS Mean change from baseline in Your Health Today Score at day 99||Statistical analysis results of Your Health Today EQ-5D-5L Index score at day 99 (PD Analysis Set)||4.29|-6.81|0.706
91755245|NCT03344640|183403683|SUPERIORITY||Difference and 90% CI versus placebo|-1.9||||0.647|TWO_SIDED|90.0|-8.79|4.99|||LS Mean|LS mean change from baseline in Your Health Today score||Statistical analysis results of Your Health Today EQ-5D-5L Index score at End of Study||4.99|-8.79|0.647
91755246|NCT03344640|183403684|SUPERIORITY||Difference and 90% CI versus placebo|0.01||||0.613|TWO_SIDED|90.0|-0.03|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at day 99 (PD Analysis Set)||0.06|-0.03|0.613
91755247|NCT03344640|183403684|SUPERIORITY||Difference and 90% CI versus placebo|0.02||||0.74|TWO_SIDED|90.0|-0.04|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at End of Study (PD Analysis Set)||0.06|-0.04|0.740
91755248|NCT03344640|183403685|SUPERIORITY||Difference and 90% CI versus placebo|-5.55||||0.281|TWO_SIDED|90.0|-14.07|2.97|||LS Mean|LS MMean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||2.97|-14.07|0.281
91755249|NCT03344640|183403685|SUPERIORITY||Difference and 90% CI versus placebo|-1.49||||0.78|TWO_SIDED|90.0|-10.33|7.35|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at End of Study||7.35|-10.33|0.780
91755250|NCT03344640|183403686|SUPERIORITY||Difference and 90% CI versus placebo|-3.32||||0.489|TWO_SIDED|90.0|-11.28|4.64|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||4.64|-11.28|0.489
91755251|NCT03344640|183403686|SUPERIORITY||Difference and 90% CI versus placebo|-8.29||||0.087|TWO_SIDED|90.0|-16.26|-0.32|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale at End of Study||-0.32|-16.26|0.087
91755252|NCT03344640|183403687|SUPERIORITY||Difference and 99% CL versus placebo|6.1||||0.21|TWO_SIDED|90.0|-1.9|13.91|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at day 99||13.91|-1.90|0.210
91755253|NCT03344640|183403687|SUPERIORITY||Difference and 90% CI versus placebo|-0.37||||0.942|TWO_SIDED|90.0|-8.86|8.11|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at End of Study||8.11|-8.86|0.942
91755254|NCT02809053|183403691|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate (%)|-4.2|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.8|6.35|||||Comparison: SAIT101 versus MabThera.|Adjusted Difference Rate (%) in Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 28.||6.35|-14.80|
91755255|NCT02809053|183403692|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate|-10.3|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-20.92|0.61|||||Comparison: SAIT101 versus MabThera|Adjusted Difference Rate of Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 12.||0.61|-20.92|
91755256|NCT02809053|183403697|OTHER|The estimated Hazard Ratio with 95% CI was obtained from Cox regression model; however, stratification factors, ie, FLIPI-2 (low, intermediate and high risk), were only taken into account if FLIPI-2 score=all.|Hazard Ratio (HR)|1.724|||||TWO_SIDED|95.0|0.853|3.482|||||Hazard Ration of TTE SAIT101:MabThera|Time to Event (TTE) Hazard Ratio (HR) of SAIT101:MabThera. The TTE is defined as the time from the date of randomization to the date when an event occurs; an event is disease progression as assessed by Investigator, death due to any cause, or the start of new treatment, whichever comes first.||3.482|0.853|
91755257|NCT02809053|183403698|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|101.39|||||TWO_SIDED|90.0|95.86|107.24|||||Comparison: SAIT101 versus MabThera. Equivalence was demonstrated for SAIT101 and MabThera with exposure pharmacokinetic parameter AUC0-168,w1 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) (%) of SAIT101 versus MabThera Area Under the Concentration time Curve Day 0 to Week 1 (AUC0-168,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||107.24|95.86|
91755258|NCT02809053|183403698|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|96.92|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter AUC0-168,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) %) of SAIT101 versus MabThera Area Under the Concentration time Cure Day 0 to Week 4 (AUC0-168,w4) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
91532994|NCT00410384|182943048|SUPERIORITY_OR_OTHER|||||||0.7962|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.7962
91508916|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.276|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2760
91508917|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.0085|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0085
91532995|NCT00410384|182943048|SUPERIORITY_OR_OTHER|||||||0.9703|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.9703
91755259|NCT02809053|183403699|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00|GLS Mean Ratio (%)|99.35|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with Cmax,w1 exposure within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 1 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
91755260|NCT02809053|183403699|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ration (%)|99.23|||||TWO_SIDED|90.0|92.96|105.92|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Cmax,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 4 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||105.92|92.96|
91755261|NCT02809053|183403702|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ratio (%)|95.45|||||TWO_SIDED|90.0|88.85|102.55|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Ctrough,d29 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera trough plasma concentration at the end of the dosing period (Day 29) (Ctrough,d29) (µg/mL) . The statistical comparison of the log-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||102.55|88.85|
91755262|NCT02809053|183403706|OTHER||Mean Difference (Final Values)|7.2|||||TWO_SIDED|90.0|-31.0|45.4|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 1 (AUEC0-168,w1), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||45.4|-31.0|
91755263|NCT02809053|183403706|OTHER||Mean Difference (Final Values)|18.0|||||TWO_SIDED|90.0|-21.6|57.6|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 2 (AUEC0-168,w2), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||57.6|-21.6|
91755264|NCT02809053|183403706|OTHER||Mean Difference (Final Values)|21.4|||||TWO_SIDED|90.0|-18.3|61.0|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 3 (AUEC0-168,w3), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||61.0|-18.3|
91755265|NCT02809053|183403706|OTHER||Mean Difference (Final Values)|20.4|||||TWO_SIDED|90.0|-19.3|60.2|||||comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 4 (AUEC0-168,w4), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||60.2|-19.3|
91755266|NCT02809053|183403706|OTHER||Mean Difference (Final Values)|15.7|||||TWO_SIDED|90.0|-23.1|54.6|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 12 (AUEC0-168,w12), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||54.6|-23.1|
91755267|NCT02809053|183403706|OTHER||Mean Difference (Final Values)|12.8|||||TWO_SIDED|90.0|-26.0|51.8|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 28 (AUEC0-168,w28), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||51.8|-26.0|
91755268|NCT02809053|183403710|OTHER|||||||0.587||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis: Comparison of Overall Response Rate (ORR) by Region (European Union / Other). The interaction p-value for the Region subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.587
91508918|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.1317|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1317
91508919|NCT00280566|182889823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.1666|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1666
91508920|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.75||0.0023|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0023
91508921|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.91||0.1412|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.1412
91508922|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.87||0.0861|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0861
91508923|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.82||0.5992|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5992
91532996|NCT00410384|182943049|SUPERIORITY_OR_OTHER|||||||0.6583|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.6583
91532997|NCT00410384|182943049|SUPERIORITY_OR_OTHER|||||||0.3762|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.3762
91755269|NCT02809053|183403710|OTHER|||||||0.421||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Overall Response Rate by Age Group (18-60 years and \>60 years). The interaction p-value for the Age subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.421
91755270|NCT02809053|183403710|OTHER|||||||0.288||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Gender (Male / Female). The interaction p-value for the Gender subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate. The p-value was calculated using Gail-Simon Test for Qualitative Interactions.||||0.288
91508924|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.76||0.5873|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5873
91508925|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.78||0.2116|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2116
91508926|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1847|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1847
91508927|NCT00280566|182889824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.82||0.9972|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9972
91508928|NCT00280566|182889825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.93||0.5954|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5954
91508929|NCT00280566|182889825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.93||0.3414|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3414
91508930|NCT00280566|182889825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.23||0.9745|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.9745
91508931|NCT00280566|182889825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.47||0.5627|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5627
91508932|NCT00280566|182889825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.1||0.741|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7410
91508933|NCT00280566|182889825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.88||0.9632|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9632
91508934|NCT00280566|182889826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.22||0.9538|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9538
91508935|NCT00280566|182889826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.25||0.8541|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8541
91755271|NCT02809053|183403710|OTHER|||||||0.588||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Wilson|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Anti-drug Antibody (ADA) status (Positive / Negative). The interaction p-value for the ADA subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.588
91508936|NCT00280566|182889826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.32||0.1084|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1084
91508937|NCT00280566|182889826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.27||0.038|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0380
91508938|NCT00280566|182889826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2649|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2649
91508939|NCT00280566|182889826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.2394|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2394
91532998|NCT00410384|182943050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.4253|TWO_SIDED|95.0|0.65|2.74|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||2.74|0.65|0.4253
91508940|NCT00280566|182889827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.29||0.8117|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8117
91508941|NCT00280566|182889827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.26||0.0443|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0443
91508942|NCT00280566|182889827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.28||0.3039|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3039
91532999|NCT00410384|182943050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2081|TWO_SIDED|95.0|0.78|3.13|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||3.13|0.78|0.2081
91755272|NCT00884832|183403779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.||||<0.001
91755273|NCT00884832|183403780|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
91533000|NCT01167023|182943054|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.26||||0.304||95.0||||Pain rate was analyzed using an analysis of covariance (ANCOVA) model, with baseline pain intensity, treatment group, and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.304
91755274|NCT00884832|183403780|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|||drug\*group interactions||||0.047
91755275|NCT00884832|183403782|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||ANCOVA|||||||0.082
91755276|NCT02337725|183403783|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.53|-4.25|||ANCOVA||Estimated Value was reported for the least squares mean difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-4.250|-8.530|<0.0001
91755277|NCT00500760|183403794|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.07|||||TWO_SIDED|95.0|-0.23|0.09|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|||0.09|-0.23|
91755278|NCT00500760|183403795|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 6 months||0.12|-0.18|
91755279|NCT00500760|183403795|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-1.09|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 12 months||0.12|-1.09|
91755280|NCT00500760|183403796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.328||||0.3106|TWO_SIDED|95.0|0.767|2.299|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||2.299|0.767|0.3106
91755281|NCT00500760|183403797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6069|TWO_SIDED|95.0|0.675|1.961|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||1.961|0.675|0.6069
91508943|NCT00280566|182889827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.46||0.9953|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9953
91508944|NCT00280566|182889827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.32||0.1653|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1653
91508945|NCT00280566|182889827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.5771|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5771
91508946|NCT01302392|182889830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.4172|TWO_SIDED|95.0|0.76|1.249||Based on 1-sided test.|Log Rank|Analysis was stratified by the number of previous therapies (3 vs 4 vs ≥ 5) and geographical region (Europe vs. non-Europe)||||1.249|0.760|0.4172
91508947|NCT01696032|182889910|SUPERIORITY|||||||0.0654|||||||Log Rank|||||||0.0654
91508948|NCT00376168|182889922|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
91508949|NCT00376168|182889922|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||threshold for statistical significance = 0.025|one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
91508950|NCT00376168|182889923|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0041
91508951|NCT00376168|182889923|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
91508952|NCT00376168|182889924|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0010
91755282|NCT00500760|183403798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.628||||0.1223|TWO_SIDED|95.0|0.877|3.019|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||3.019|0.877|0.1223
91508953|NCT00376168|182889924|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
91508954|NCT00376168|182889925|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0460
91755283|NCT00500760|183403799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.1737|TWO_SIDED|95.0|0.217|1.262|||Regression, Logistic||The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||1.262|0.217|0.1737
91755284|NCT00500760|183403799|SUPERIORITY_OR_OTHER||Difference in rate|-10.99|||||TWO_SIDED|95.0|-24.56|4.14|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||4.14|-24.56|
91755285|NCT00500760|183403800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||1|TWO_SIDED|95.0|0.448|2.712|||Regression, Logistic||The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||2.712|0.448|1.0000
91508955|NCT00376168|182889925|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0031
91508956|NCT02203591|182889966|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91508957|NCT02203591|182889966|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91508958|NCT02203591|182889966|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91755286|NCT00500760|183403800|SUPERIORITY_OR_OTHER||Difference in rate|1.33|||||TWO_SIDED|95.0|-13.23|14.71|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||14.71|-13.23|
91755287|NCT01264770|183403801|SUPERIORITY_OR_OTHER||Treatment difference|0.56||||0.006|TWO_SIDED|90.0|0.23|0.9|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.90|0.23|0.006
91508959|NCT02203591|182889966|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91508960|NCT02203591|182889966|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91508961|NCT02203591|182889966|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91508962|NCT02203591|182889966|OTHER|95% confidence interval generation|Mean value|81.1|||||TWO_SIDED|95.0|75.6|86.6||||||||86.6|75.6|
91508963|NCT02203591|182889966|OTHER|95% confidence interval generation|Mean value|81.7|||||TWO_SIDED|95.0|76.3|87.1||||||||87.1|76.3|
91508964|NCT02203591|182889966|OTHER|95% confidence interval generation|Mean value|83.2|||||TWO_SIDED|95.0|77.9|88.4||||||||88.4|77.9|
91508965|NCT02203591|182889966|OTHER|95% confidence interval generation|Mean value|38.9|||||TWO_SIDED|95.0|32.3|45.6||||||||45.6|32.3|
91508966|NCT02203591|182889966|OTHER|95% confidence interval generation|Mean value|46.9|||||TWO_SIDED|95.0|40.1|53.7||||||||53.7|40.1|
91508967|NCT02203591|182889966|OTHER|95% confidence interval generation|Mean value|53.0|||||TWO_SIDED|95.0|46.3|59.6||||||||59.6|46.3|
91755288|NCT01264770|183403801|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.022|TWO_SIDED|90.0|0.14|0.84|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.84|0.14|0.022
91759774|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-4.03|0.42||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-4.03|
91759775|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-5.04|-0.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-5.04|
91759776|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|||||TWO_SIDED|95.0|-5.07|-0.64||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.64|-5.07|
91759777|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|||||TWO_SIDED|95.0|-4.98|-0.56||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.56|-4.98|
91759778|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.63|||||TWO_SIDED|95.0|-3.85|0.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.59|-3.85|
91759779|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.27|||||TWO_SIDED|95.0|-5.48|-1.06||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.06|-5.48|
91759780|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23|||||TWO_SIDED|95.0|-4.66|0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.20|-4.66|
91759781|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-6.62|-1.77||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.77|-6.62|
91759782|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.73|||||TWO_SIDED|95.0|-6.15|-1.31||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.31|-6.15|
91759783|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.09|-1.26||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.26|-6.09|
91508968|NCT02203591|182889967|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.57|-0.1|||||3M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal|||-0.10|-0.57|
91508969|NCT02203591|182889967|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|97.5|-0.44|0.74|||||3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal|Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.||0.74|-0.44|
91755289|NCT01264770|183403801|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.28|TWO_SIDED|90.0|-0.12|0.56|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.56|-0.12|0.280
91755290|NCT01264770|183403802|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.005|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.005
91508970|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.85|||TWO_SIDED|||||||||||||
91508971|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|2.86|STANDARD_DEVIATION|0.9|||TWO_SIDED|||||||||||||
91759784|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-4.69|0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-4.69|
91759785|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.11|||||TWO_SIDED|95.0|-6.52|-1.7||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.70|-6.52|
91759786|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.34|-0.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-5.34|
91759787|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-6.93|-1.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.83|-6.93|
91759788|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.0|-7.74|-2.66||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.66|-7.74|
91759789|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|||||TWO_SIDED|95.0|-7.43|-2.36||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.36|-7.43|
91759790|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74|||||TWO_SIDED|95.0|-5.28|-0.2||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-5.28|
91759791|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.57|||||TWO_SIDED|95.0|-7.1|-2.05||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.05|-7.10|
91759792|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.73|3.33||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.33|-0.73|
91759793|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-2.18|1.84||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.84|-2.18|
91759794|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|-1.61|2.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.44|-1.61|
91759795|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-2.27|1.73||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.73|-2.27|
91759796|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|-0.74|3.68||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.68|-0.74|
91508972|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
91508973|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|1.0|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
91755291|NCT01264770|183403802|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.61||||0.02|TWO_SIDED|80.0|-0.94|-0.27|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.27|-0.94|0.020
91755292|NCT01264770|183403802|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.004|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.004
91755293|NCT01264770|183403803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05||||0.005|TWO_SIDED|90.0|1.59|5.86|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.86|1.59|0.005
91755294|NCT01264770|183403803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.001|TWO_SIDED|90.0|2.1|8.05|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.05|2.10|<0.001
91508974|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|3.46|STANDARD_DEVIATION|1.31|||TWO_SIDED|||||||||||||
91508975|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|3.49|STANDARD_DEVIATION|1.33|||TWO_SIDED|||||||||||||
91508976|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|3.69|STANDARD_DEVIATION|1.29|||TWO_SIDED|||||||||||||
91508977|NCT02203591|182889968|OTHER|Calculate mean value|Mean value|1.23|STANDARD_DEVIATION|0.73|||TWO_SIDED|||||||||||||
91508978|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|2.78|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
91508979|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.0|||TWO_SIDED|||||||||||||
91508980|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|2.75|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
91508981|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|0.76|STANDARD_DEVIATION|0.81|||TWO_SIDED|||||||||||||
91508982|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|2.84|STANDARD_DEVIATION|1.19|||TWO_SIDED|||||||||||||
91508983|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|2.99|STANDARD_DEVIATION|1.12|||TWO_SIDED|||||||||||||
91508984|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|3.17|STANDARD_DEVIATION|1.24|||TWO_SIDED|||||||||||||
91508985|NCT02203591|182889969|OTHER|Calculate mean value|Mean value|1.01|STANDARD_DEVIATION|0.67|||TWO_SIDED|||||||||||||
91508986|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|0.8|STANDARD_DEVIATION|0.84|||TWO_SIDED|||||||||||||
91508987|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|0.74|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||||||
91508988|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|0.81|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
91508989|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|2.65|STANDARD_DEVIATION|0.89|||TWO_SIDED|||||||||||||
91508990|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|2.76|STANDARD_DEVIATION|1.2|||TWO_SIDED|||||||||||||
91508991|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.22|||TWO_SIDED|||||||||||||
91508992|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|2.58|STANDARD_DEVIATION|1.18|||TWO_SIDED|||||||||||||
91508993|NCT02203591|182889970|OTHER|Calculate mean value|Mean value|4.85|STANDARD_DEVIATION|0.75|||TWO_SIDED|||||||||||||
91508994|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|0.85|STANDARD_DEVIATION|0.95|||TWO_SIDED|||||||||||||
91508995|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|0.87|STANDARD_DEVIATION|0.98|||TWO_SIDED|||||||||||||
91508996|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|0.89|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
91508997|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|2.88|STANDARD_DEVIATION|0.7|||TWO_SIDED|||||||||||||
91508998|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|3.39|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||||||
91508999|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|3.21|STANDARD_DEVIATION|1.04|||TWO_SIDED|||||||||||||
91509000|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|3.08|STANDARD_DEVIATION|1.14|||TWO_SIDED|||||||||||||
91509001|NCT02203591|182889971|OTHER|Calculate mean value|Mean value|5.08|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||||||
91509002|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|3.63|STANDARD_DEVIATION|0.46|||TWO_SIDED|||||||||||||
91509003|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|3.61|STANDARD_DEVIATION|0.48|||TWO_SIDED|||||||||||||
91509004|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.49|||TWO_SIDED|||||||||||||
91755295|NCT01264770|183403803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.335|TWO_SIDED|90.0|0.76|2.83|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.76|0.335
91755296|NCT01264770|183403804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|90.0|0.2|0.68|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.68|0.20|0.007
91755297|NCT01264770|183403804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.051|TWO_SIDED|90.0|0.26|0.89|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.89|0.26|0.051
91755298|NCT01264770|183403804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.004|TWO_SIDED|90.0|0.2|0.65|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.65|0.20|0.004
91755299|NCT01264770|183403805|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.29|||<|0.001|TWO_SIDED|90.0|0.17|0.4||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.40|0.17|<0.001
91509005|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.53|||TWO_SIDED|||||||||||||
91509006|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|6.23|STANDARD_DEVIATION|0.6|||TWO_SIDED|||||||||||||
91509007|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|6.22|STANDARD_DEVIATION|0.56|||TWO_SIDED|||||||||||||
91509008|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|6.27|STANDARD_DEVIATION|0.62|||TWO_SIDED|||||||||||||
91509009|NCT02203591|182889972|OTHER|Calculate mean value|Mean value|6.09|STANDARD_DEVIATION|0.63|||TWO_SIDED|||||||||||||
91509010|NCT04115358|182889976|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509011|NCT04115358|182889977|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509012|NCT04115358|182889978|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509013|NCT04115358|182889979|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509014|NCT04115358|182889980|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509015|NCT04115358|182889981|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509016|NCT04115358|182889982|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509017|NCT04115358|182889983|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509018|NCT04115358|182889984|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509019|NCT04115358|182889985|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91759797|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.76|2.65||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.65|-1.76|
91759798|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-1.79|2.63||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.63|-1.79|
91759799|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-1.69|2.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.70|-1.69|
91755300|NCT01264770|183403805|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.43||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|0.18|<0.001
91509020|NCT04115358|182889986|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509021|NCT04115358|182889987|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509022|NCT04115358|182889988|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509023|NCT04115358|182889989|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509024|NCT04115358|182889990|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509025|NCT04115358|182889991|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91533001|NCT01167023|182943056|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.051|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time\*treatment interaction as fixed effects, and participant as a random effect in the model was used.|Mixed Models Analysis||Least Squares Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
91509026|NCT04115358|182889992|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91533002|NCT01167023|182943057|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.244||95.0||||Average pain intensity was analyzed using an analysis of covariance (ANCOVA) model, with baseline intensity, treatment group and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.244
91533003|NCT01167023|182943058|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-128.3|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time and time\*treatment interaction as fixed effects, and participant as a random effect in the model.|Mixed Models Analysis||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
91509027|NCT04115358|182889993|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509028|NCT04115358|182889994|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509029|NCT04115358|182889995|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509030|NCT04115358|182889996|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509031|NCT04115358|182889997|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509032|NCT04115358|182889998|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509033|NCT04115358|182889999|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509034|NCT04115358|182890000|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509035|NCT04115358|182890001|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509036|NCT04115358|182890002|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509037|NCT04115358|182890003|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91533004|NCT01253980|182943083|SUPERIORITY_OR_OTHER||Relative risk|0.6|||>|0.5|TWO_SIDED|95.0|0.11|3.37|||Fisher Exact|||||3.37|0.11|>0.50
91509038|NCT04115358|182890004|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509039|NCT04115358|182890005|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91755301|NCT01264770|183403805|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.19||||0.007|TWO_SIDED|90.0|0.07|0.31||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.31|0.07|0.007
91509040|NCT04115358|182890006|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91509041|NCT04115358|182890007|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
91755302|NCT01264770|183403805|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.16||||0.049|TWO_SIDED|90.0|-0.3|-0.03||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.03|-0.30|0.049
91755303|NCT01264770|183403805|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.803|TWO_SIDED|90.0|-0.16|0.12||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.16|0.803
91755304|NCT01264770|183403805|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.24||||0.003|TWO_SIDED|90.0|-0.37|-0.1||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.10|-0.37|0.003
91755305|NCT01264770|183403806|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.059|TWO_SIDED|90.0|0.01|0.18||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.01|0.059
91755306|NCT01264770|183403806|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.071|TWO_SIDED|90.0|0.01|0.17||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.01|0.071
91755307|NCT01264770|183403806|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.01||||0.758|TWO_SIDED|90.0|-0.05|0.07||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|-0.05|0.758
91759800|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.53|4.29||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-0.53|
91509042|NCT00835497|182890008|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|86.5||||||90.0|81.8|91.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||91.6|81.8|
91509043|NCT00835497|182890009|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.9|94.2|
91509044|NCT00835497|182890010|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|94.2|
91509045|NCT00835497|182890011|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|88.9||||||90.0|83.5|94.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||94.6|83.5|
91509046|NCT00835497|182890012|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|88.4|97.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.1|88.4|
91509047|NCT00835497|182890013|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|88.8|97.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.5|88.8|
91509048|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.264|TWO_SIDED|95.0|-0.019|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.019|0.264
91509049|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.165|TWO_SIDED|95.0|-0.013|0.079|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.079|-0.013|0.165
91509050|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.271|TWO_SIDED|95.0|-0.02|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.020|0.271
91509051|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.100|0.010|0.018
91509052|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.101|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.101|0.010|0.018
91509053|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.078|||<|0.001|TWO_SIDED|95.0|0.032|0.124|||Mixed Models Analysis|||||0.124|0.032|<0.001
91509054|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.052||||0.023|TWO_SIDED|95.0|-0.097|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.097|0.023
91509055|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.051|TWO_SIDED|95.0|-0.091|0.0|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.000|-0.091|0.051
91509056|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.053||||0.023|TWO_SIDED|95.0|-0.098|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.098|0.023
91509057|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.306|TWO_SIDED|95.0|-0.068|0.021|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.021|-0.068|0.306
91509058|NCT01573624|182890016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.023||||0.33|TWO_SIDED|95.0|-0.068|0.023|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.023|-0.068|0.330
91759801|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-2.5|2.33||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.33|-2.50|
91759802|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-2.03|2.79||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.79|-2.03|
91759803|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.97|2.84||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.84|-1.97|
91759804|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-0.75|4.3||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.75|
91759805|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-2.34|2.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.73|-2.34|
91759806|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-3.14|1.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.89|-3.14|
91759807|NCT01393639|183411980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|||||TWO_SIDED|95.0|-2.84|2.19||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.19|-2.84|
91759808|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.91|0.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-2.91|
91759809|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.45|||||TWO_SIDED|95.0|-4.17|-0.73||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-4.17|
91759810|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-3.76|-0.29||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.29|-3.76|
91759811|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|||||TWO_SIDED|95.0|-4.82|-1.4||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.40|-4.82|
91759812|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-3.13|0.33||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-3.13|
91759813|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-4.52|-1.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.07|-4.52|
91759814|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.67|||||TWO_SIDED|95.0|-3.63|0.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.29|-3.63|
91759815|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-3.94|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-3.94|
91759816|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-4.03|-0.11||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-4.03|
91759817|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-5.09|-1.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.09|
91759818|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-3.85|0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-3.85|
91755308|NCT01264770|183403806|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.12||||0.114|TWO_SIDED|90.0|-0.24|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-0.24|0.114
91509059|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.9|||<|0.001|TWO_SIDED|95.0|9.5|22.3|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.3|9.5|<0.001
91755309|NCT01264770|183403806|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.14||||0.078|TWO_SIDED|90.0|-0.26|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.26|0.078
91509060|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.001|TWO_SIDED|95.0|10.9|23.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||23.9|10.9|<0.001
91509061|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|12.1|25.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||25.1|12.1|<0.001
91509062|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.5|29.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.4|16.5|<0.001
91509063|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|15.5|28.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.4|15.5|<0.001
91755310|NCT01264770|183403806|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.21||||0.003|TWO_SIDED|90.0|-0.32|-0.09||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.09|-0.32|0.003
91755311|NCT01264770|183403807|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.46|TWO_SIDED|90.0|-0.07|0.03||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.03|-0.07|0.460
91755312|NCT01264770|183403807|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.0||||0.903|TWO_SIDED|90.0|-0.05|0.06||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.06|-0.05|0.903
91509064|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0|||<|0.001|TWO_SIDED|95.0|20.6|33.5|||Mixed Models Analysis|||||33.5|20.6|<0.001
91509065|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-17.6|-4.7|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-4.7|-17.6|<0.001
91509066|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6||||0.004|TWO_SIDED|95.0|-16.1|-3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.1|-16.1|0.004
91509067|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.4||||0.012|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-1.9|-14.9|0.012
91509068|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.209|TWO_SIDED|95.0|-10.6|2.3|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||2.3|-10.6|0.209
91509069|NCT01573624|182890017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1||||0.124|TWO_SIDED|95.0|-11.6|1.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.4|-11.6|0.124
91509070|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.2|||<|0.001|TWO_SIDED|95.0|9.5|22.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.9|9.5|<0.001
91509071|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.2|||<|0.001|TWO_SIDED|95.0|10.5|24.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||24.0|10.5|<0.001
91509072|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2|||<|0.001|TWO_SIDED|95.0|14.4|28.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.0|14.4|<0.001
91509073|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.5|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||35.5|22.1|<0.001
91509074|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.2|29.6|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.6|16.2|<0.001
91509075|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6|||<|0.001|TWO_SIDED|95.0|19.8|33.4|||Mixed Models Analysis|||||33.4|19.8|<0.001
91533005|NCT02820051|182943131|SUPERIORITY|||||||0.281||||||threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||The sample was calculated with alpha 0.05, beta 0.20, standard deviation of 7.3,8 minimum PtcCO2 difference to detect of 5 mmHg, loss to follow-up estimated 0.20, and two-tails. According to the above, the sample size was 42 patients per group.|We tested normal distribution with the Kolmogorov-Smirnov test. Data are shown as means and standard deviations for variables with normal distribution and as medians and interquartile ranges for non-normal variables. We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05. The analysis was performed using SPSS version 18.0 for Windows (SPSS Inc., Chicago, IL).|||0.281
91533006|NCT02820051|182943132|SUPERIORITY|We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91533007|NCT02820051|182943133|SUPERIORITY|T test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91509076|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3||||0.003|TWO_SIDED|95.0|-17.2|-3.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.5|-17.2|0.003
91509077|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.007|TWO_SIDED|95.0|-16.2|-2.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-2.5|-16.2|0.007
91509078|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.4||||0.126|TWO_SIDED|95.0|-12.3|1.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.5|-12.3|0.126
91509079|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.523||95.0|-4.6|9.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||9.1|-4.6|0.523
91509080|NCT01573624|182890018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7||||0.29|TWO_SIDED|95.0|-10.5|3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||3.1|-10.5|0.290
91509081|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.036|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.036
91755313|NCT01264770|183403807|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.03||||0.172|TWO_SIDED|90.0|-0.08|0.01||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.01|-0.08|0.172
91509082|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.064|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.064
91533008|NCT04883346|182943143|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_DEVIATION|3.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 32 degrees of freedom (one participant did not have baseline DEXA data so could not be included.||||||<0.001
91533009|NCT04883346|182943144|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom.||||||<0.001
91533010|NCT04883346|182943145|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.1|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
91533011|NCT04883346|182943146|SUPERIORITY|Paired t-test.|Mean Difference (Final Values)|-4.4|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
91533012|NCT01670500|182943147|OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|90.0|0.39|1.2|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.2|0.39|
91533013|NCT01670500|182943148|OTHER||Risk Ratio (RR)|0.73|||||TWO_SIDED|90.0|0.5|1.1|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.1|.5|
91533014|NCT04955626|182943152|OTHER||Adjusted Surveillance Time|95.3|||||TWO_SIDED|95.0|89.5|98.3||||||2-Sided CI for Relative vaccine efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.||98.3|89.5|
91533015|NCT04955626|182943153|OTHER||Adjusted Surveillance Time|94.6|||||TWO_SIDED|95.0|88.5|97.9||||||2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.||97.9|88.5|
91533016|NCT04955626|182943154|OTHER||Adjusted Surveillance Time|63.9|||||TWO_SIDED|95.0|51.1|73.5||||||2-Sided CI for Relative Vaccine Efficacy (RVE) is derived based on the Clopper and Pearson method adjusted for surveillance time.||73.5|51.1|
91533017|NCT04955626|182943155|OTHER||Adjusted Surveillance Time|62.4|||||TWO_SIDED|95.0|49.5|72.2||||||2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.||72.2|49.5|
91509083|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.335|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.1|-0.3|0.335
91509084|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.012|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||-0.1|-0.5|0.012
91509085|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.023|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.023
91509086|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
91509087|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.104|TWO_SIDED|95.0|0.0|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|0.0|0.104
91509088|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.062|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.5|0.0|0.062
91509089|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.006|TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.6|0.1|0.006
91509090|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.217|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.217
91509091|NCT01573624|182890019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.143|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.143
91533018|NCT04955626|182943193|OTHER||Geometric Mean Ration (GMR)|1.75|||||TWO_SIDED|95.0|1.39|2.22||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]) and the corresponding CI (based on the student t distribution).||2.22|1.39|
91755314|NCT01264770|183403807|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.082|TWO_SIDED|90.0|-0.21|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.21|0.082
91533019|NCT04955626|182943194|OTHER||Difference in Percentages|23.0|||||TWO_SIDED|95.0|11.1|34.3||||||Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||34.3|11.1|
91755315|NCT01264770|183403807|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.092|TWO_SIDED|90.0|-0.21|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.00|-0.21|0.092
91759819|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84|||||TWO_SIDED|95.0|-4.79|-0.88||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.88|-4.79|
91509092|NCT04399161|182890020|SUPERIORITY|||||||0.123|||||||ANOVA|||Comparison among Children||||0.123
91509093|NCT04399161|182890020|SUPERIORITY|||||||0.314|||||||ANOVA|||Comparison among Elderly||||0.314
91509094|NCT03417141|182890021|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Week 12||||0.014
91509095|NCT03417141|182890021|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.006
91509096|NCT03417141|182890022|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
91509097|NCT03417141|182890023|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91509098|NCT03417141|182890024|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91509099|NCT01723228|182890025|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.8||||0.2204|TWO_SIDED|95.0|-0.48|2.05|||repeated measures model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||2.05|-0.48|0.2204
91509100|NCT01723228|182890026|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.8428|TWO_SIDED|95.0|-0.99|0.81|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||0.81|-0.99|0.8428
91533020|NCT04955626|182943195|OTHER||Geometric Mean Ration (GMR)|2.87|||||TWO_SIDED|95.0|2.18|3.78||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]) and the corresponding CI (based on the student t distribution).||3.78|2.18|
91509101|NCT01723228|182890027|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7||||0.4796|TWO_SIDED|95.0|-2.74|1.3|||ANCOVA|The statistical model is an analysis of covariance (ANCOVA) with treatment, center, baseline score, and age as fixed effects.||||1.30|-2.74|0.4796
91509102|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.1148|TWO_SIDED|95.0|0.89|2.93|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC||2.93|0.89|0.1148
91509103|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1052|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the Cochran-Mantel-Haenszel (CMH) p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC||||0.1052
91509104|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8857|TWO_SIDED|95.0|0.52|1.75|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Cognition||1.75|0.52|0.8857
91509105|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9945|TWO_SIDED|||||For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.|Cochran-Mantel-Haenszel|||CGIC Cognition||||0.9945
91509106|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.6909|TWO_SIDED|95.0|0.56|2.43|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Behavior||2.43|0.56|0.6909
91755316|NCT01264770|183403807|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.17||||0.002|TWO_SIDED|90.0|-0.27|-0.08||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.08|-0.27|0.002
91755317|NCT01264770|183403808|SUPERIORITY_OR_OTHER||Treatment difference|23.39|||<|0.001|TWO_SIDED|90.0|9.57|40.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||40.00|9.57|<0.001
91755318|NCT01264770|183403808|SUPERIORITY_OR_OTHER||Treatment difference|22.97||||0.006|TWO_SIDED|90.0|7.84|38.34|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||38.34|7.84|0.006
91755319|NCT01264770|183403808|SUPERIORITY_OR_OTHER||Treatment difference|5.72||||0.234|TWO_SIDED|90.0|-3.2|21.68|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||21.68|-3.20|0.234
91755320|NCT01264770|183403809|SUPERIORITY_OR_OTHER||Treatment difference|-13.72||||0.03|TWO_SIDED|90.0|-25.01|0.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-25.01|0.030
91509107|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6639|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Behavior||||0.6639
91509108|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.3204|TWO_SIDED|95.0|0.72|2.68|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Functional Abilities||2.68|0.72|0.3204
91755321|NCT01264770|183403809|SUPERIORITY_OR_OTHER||Treatment difference|-9.49||||0.207|TWO_SIDED|90.0|-25.0|6.96|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||6.96|-25.00|0.207
91755322|NCT01264770|183403809|SUPERIORITY_OR_OTHER||Treatment difference|-19.53||||0.002|TWO_SIDED|90.0|-30.01|-6.25|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-6.25|-30.01|0.002
91755323|NCT01264770|183403810|SUPERIORITY_OR_OTHER||Treatment difference|0.24||||0.007|TWO_SIDED|90.0|0.09|0.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.38|0.09|0.007
91755324|NCT01264770|183403810|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.016|TWO_SIDED|90.0|0.07|0.37|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.37|0.07|0.016
91755325|NCT01264770|183403810|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.094|TWO_SIDED|90.0|0.0|0.29|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.00|0.094
91509109|NCT01723228|182890028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Functional Abilities||||0.3331
91509110|NCT01723228|182890029|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.5||||0.0151|TWO_SIDED|95.0|-4.47|-0.49|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-0.49|-4.47|0.0151
91509111|NCT01723228|182890030|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.3||||0.0003|TWO_SIDED|95.0|-3.53|-1.08|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-1.08|-3.53|0.0003
91509112|NCT02239536|182890056|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
91509113|NCT02239536|182890057|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
91509114|NCT02239536|182890057|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
91509115|NCT05036642|182890074|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.02
91509116|NCT05036642|182890075|OTHER|||||||0.01|||||||ANOVA|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.01
91509117|NCT05036642|182890076|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.48
91509118|NCT01610700|182890081|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.93||||0.124||95.0|-13.52|1.65|||ANCOVA|||The change in the primary impairment was compared between treatment groups using analysis of covariance (ANCOVA) with baseline primary impairment score as the covariate.||1.65|-13.52|0.124
91509119|NCT01610700|182890082|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.062|TWO_SIDED|95.0|-14.56|0.37|||ANCOVA|||The change in the spasticity visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.37|-14.56|0.062
91509120|NCT01610700|182890083|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.88||||0.731|TWO_SIDED|95.0|-12.73|8.96|||ANCOVA|||The change in the pain visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||8.96|-12.73|0.731
91755326|NCT01264770|183403811|SUPERIORITY_OR_OTHER||Treatment difference|-0.2||||0.043|TWO_SIDED|90.0|-0.36|-0.04|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.04|-0.36|0.043
91755327|NCT01264770|183403811|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.158|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.02|-0.31|0.158
91755328|NCT01264770|183403811|SUPERIORITY_OR_OTHER||Treatment difference|-0.32||||0.001|TWO_SIDED|90.0|-0.47|-0.16|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.16|-0.47|0.001
91755329|NCT01264770|183403812|SUPERIORITY_OR_OTHER||Treatment difference|-2.77||||0.05|TWO_SIDED|90.0|-5.08|-0.45|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.45|-5.08|0.050
91755330|NCT01264770|183403812|SUPERIORITY_OR_OTHER||Treatment difference|-1.33||||0.36|TWO_SIDED|90.0|-3.73|1.06|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.06|-3.73|0.360
91755331|NCT01264770|183403812|SUPERIORITY_OR_OTHER||Treatment difference|-2.99||||0.032|TWO_SIDED|90.0|-5.29|-0.7|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.70|-5.29|0.032
91509121|NCT01610700|182890084|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.3||||0.443|TWO_SIDED|95.0|-11.82|5.21|||ANCOVA|||The change in the muscle spasm visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||5.21|-11.82|0.443
91509122|NCT01610700|182890085|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.85||||0.311|TWO_SIDED|95.0|-20.31|6.6|||ANCOVA|||The change in the tremor visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.60|-20.31|0.311
91509123|NCT01610700|182890086|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.26|STANDARD_ERROR_OF_MEAN|4.36||0.154|TWO_SIDED|95.0|-14.9|2.38|||ANCOVA|||The change in bladder problems visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.38|-14.90|0.154
91509124|NCT01610700|182890087|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.293|TWO_SIDED|95.0|0.77|2.43|||Fisher Exact|||The proportion of subjects with better/much better assessments was compared between groups using a Fisher's Exact Test.||2.43|0.77|0.293
91509125|NCT01610700|182890089|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.69||||0.45|TWO_SIDED|95.0|-1.11|2.5|||ANCOVA|||The change from baseline in the mean Beck's Depression Inventory score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.50|-1.11|0.450
91509126|NCT01610700|182890090|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12||||0.427|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA|||The change baseline in the mean Fatigue Severity Scale Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.18|-0.43|0.427
91509127|NCT01610700|182890092|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.72||||0.647|TWO_SIDED|95.0|-2.38|3.82|||ANCOVA|||The change from baseline in the mean total 28-item General Health Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.82|-2.38|0.647
91509128|NCT01610700|182890094|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12|STANDARD_ERROR_OF_MEAN|0.83||0.889|TWO_SIDED|95.0|-1.77|1.54|||ANCOVA|||The change from baseline in the mean total bladder control test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.54|-1.77|0.889
91509129|NCT01610700|182890097|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.047|TWO_SIDED|95.0|-14.11|-0.08|||ANCOVA|||The from baseline in the mean sleep quality 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||-0.08|-14.11|0.047
91509130|NCT01610700|182890098|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.53||||0.198|TWO_SIDED|95.0|-11.45|2.4|||ANCOVA|||The change from baseline in the mean sleep amount 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.40|-11.45|0.198
91509131|NCT01610700|182890099|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.36||||0.717|TWO_SIDED|95.0|-8.8|6.07|||ANCOVA|||The from baseline in the mean feeling upon wakening 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.07|-8.80|0.717
91755332|NCT01264770|183403813|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.568|TWO_SIDED|90.0|-3.95|1.92|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.92|-3.95|0.568
91509132|NCT01610700|182890100|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.47||||0.087|TWO_SIDED|95.0|-1.01|0.07|||ANCOVA|||The change from baseline in the mean Barthel Activities for Daily Living scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.07|-1.01|0.087
91755333|NCT01264770|183403813|SUPERIORITY_OR_OTHER||Treatment difference|-1.66||||0.368|TWO_SIDED|90.0|-4.69|1.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.38|-4.69|0.368
91755334|NCT01264770|183403813|SUPERIORITY_OR_OTHER||Treatment difference|-2.48||||0.16|TWO_SIDED|90.0|-5.38|0.43|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|-5.38|0.160
91509133|NCT01610700|182890104|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.81||||0.048|TWO_SIDED|95.0|0.02|3.6|||ANCOVA|||The change from baseline in the mean Guy's Neurological Disability Scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.60|0.02|0.048
91509134|NCT01610700|182890105|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.904|TWO_SIDED|95.0|-1.85|1.64|||ANCOVA|||The change from baseline in the mean Atkinson Morley Information Processing Battery test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.64|-1.85|0.904
91509135|NCT01706952|182890106|SUPERIORITY_OR_OTHER|For surgical field grade, we calculated the mean within sides and assessed its difference, reporting a 95% confidence interval as calculated by a Student t test. We used the average per patient over time.||||||0.05|||||||t-test, 2 sided|||Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p \< 0.05).|"For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference, reporting a 95% con- fidence interval as calculated by a Student t test. As all of these values were measured over time, we used the average per patient over time. The total blood loss per side within subjects was also calculated, with 95% confidence interval again calculated by a Student t test. Once again, we took the average per patient over time as the main outcome.~Finally, we used a linear regression with surgical field improvement as the outcome and HR, MAP, or etCO2 as covariates, to investigate which variables may be related to the outcome. As these measures were taken over time, we used repeated measures analysis to investigate how these items correlate over time.~In addition to the operating surgeon, the statistician was blinded to the vasoconstrictor allocation."|||0.05
91755335|NCT00129961|183403814|SUPERIORITY_OR_OTHER|||||||0.022||||||Poisson regression was used to model NMSC counts using the years in study as an offset. The generalized estimated equations (GEE) approach was used to estimate parameters and compare treatment differences.|Poisson regression|Adjusted by baseline strata; Poisson model = strata + treatment.||||||0.022
91755336|NCT00129961|183403815|SUPERIORITY_OR_OTHER|||||||0.047|||||||Regression, Cox|Stratified by baseline lesions||||||0.047
91755337|NCT00129961|183403816|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.015
91755338|NCT00129961|183403817|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||Chi-squared|||||||0.799
91755339|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Well differentiated||||0.014
91755340|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Moderately differentiated||||0.491
91755341|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.905||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Poorly differentiated||||0.905
91755342|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive||||0.018
91755343|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC In Situ||||0.012
91755344|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.463||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive with Perineural Invasion||||0.463
91755345|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive without Perineural Invasion||||0.004
91755346|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Superficial||||0.094
91755347|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Nodular||||0.720
91755348|NCT00129961|183403818|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Infiltrative||||0.227
91755349|NCT00129961|183403819|SUPERIORITY_OR_OTHER|||||||0.748||95.0|||||Poisson regression|||||||0.748
91755350|NCT00129961|183403820|SUPERIORITY_OR_OTHER|||||||0.425||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.425
91755351|NCT00129961|183403823|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
91755352|NCT00129961|183403824|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||ANCOVA|||||||0.672
91755353|NCT00129961|183403825|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
91755354|NCT00129961|183403826|SUPERIORITY_OR_OTHER|||||||0.588||95.0|||||Fisher Exact|||||||0.588
91755355|NCT00129961|183403827|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
91755356|NCT00129961|183403828|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.030
91755357|NCT04881747|183403869|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.875|||||TWO_SIDED|90.0|0.834|0.919||||||||0.919|0.834|
91755358|NCT04881747|183403869|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.889|||||TWO_SIDED|90.0|0.846|0.934||||||||0.934|0.846|
91755359|NCT04881747|183403870|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.914|0.976||||||||0.976|0.914|
91755360|NCT04881747|183403870|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.946|||||TWO_SIDED|90.0|0.914|0.978||||||||0.978|0.914|
91755361|NCT04881747|183403871|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.941|||||TWO_SIDED|90.0|0.91|0.972||||||||0.972|0.910|
91755362|NCT04881747|183403871|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.913|0.977||||||||0.977|0.913|
91755363|NCT02138240|183403875|OTHER|Pre-post comparison|||||<|0.001|||||||Wilcoxon signed rank sum|||||||<0.001
91755364|NCT02138240|183403878|OTHER|Pre-post comparison of baseline median weight to median weight at 6-month follow up||||||0.21|||||||Wilcoxon signed rank sum|||||||0.21
91755365|NCT03869333|183403900|OTHER|||||||0.504|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.504
91509136|NCT01221441|182890141|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
91755366|NCT03869333|183403900|OTHER|||||||0.01|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.010
91755367|NCT03869333|183403900|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.038
91755368|NCT03869333|183403900|OTHER|||||||0.016|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.016
91755369|NCT03869333|183403900|OTHER|||||||0.058|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.058
91755370|NCT03869333|183403900|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.038
91755371|NCT03869333|183403901|OTHER|||||||0.129|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.129
91755372|NCT03869333|183403901|OTHER|||||||0.017|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.017
91755373|NCT03869333|183403901|OTHER|||||||0.008|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.008
91755374|NCT03869333|183403901|OTHER|||||||0.011|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.011
91755375|NCT03869333|183403901|OTHER|||||||0.029|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.029
91533021|NCT04955626|182943196|OTHER||Geometric Mean Ratio (GMR)|2.64|||||TWO_SIDED|95.0|2.06|3.38||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]) and the corresponding CI (based on the student t distribution).||3.38|2.06|
91755376|NCT03869333|183403901|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.042
91755377|NCT03869333|183403902|OTHER|||||||0.226|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.226
91755378|NCT03869333|183403902|OTHER|||||||0.601|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.601
91755379|NCT03869333|183403902|OTHER|||||||0.628|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.628
91755380|NCT03869333|183403902|OTHER|||||||0.878|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.878
91755381|NCT03869333|183403903|OTHER|||||||0.762|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.762
91755382|NCT03869333|183403903|OTHER|||||||0.335|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.335
91755383|NCT03869333|183403903|OTHER|||||||0.229|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.229
91755384|NCT03869333|183403903|OTHER|||||||0.102|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.102
91755385|NCT03869333|183403904|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.828
91533022|NCT04955626|182943197|OTHER||Difference in Percentages|29.0|||||TWO_SIDED|95.0|17.2|40.3||||||Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||40.3|17.2|
91755386|NCT03869333|183403904|OTHER|||||||0.629|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.629
91755387|NCT03869333|183403904|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||>0.999
91755388|NCT03869333|183403904|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
91755389|NCT03869333|183403904|OTHER|||||||0.825|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||0.825
91755390|NCT03869333|183403905|OTHER|||||||0.005|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.005
91755391|NCT03869333|183403905|OTHER|||||||0.082|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.082
91755392|NCT03869333|183403905|OTHER|||||||0.293|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.293
91755393|NCT03869333|183403905|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
91755394|NCT03869333|183403905|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||>0.999
91755395|NCT03869333|183403906|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||0.828
91755396|NCT03869333|183403906|OTHER|||||||0.913|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.913
91755397|NCT03869333|183403906|OTHER|||||||0.924|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.924
91755398|NCT03869333|183403907|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||>0.999
91755399|NCT03869333|183403907|OTHER|||||||0.412|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.412
91533023|NCT04955626|182943198|OTHER||Difference in Percentages|21.0|||||TWO_SIDED|95.0|8.3|33.2||||||Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||33.2|8.3|
91533024|NCT04955626|182943199|OTHER||Geometric Mean Ration (GMR)|9.95|||||TWO_SIDED|95.0|7.9|12.53||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]) and the corresponding CI (based on the student t distribution).||12.53|7.90|
91755400|NCT03869333|183403907|OTHER|||||||0.847|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.847
91509137|NCT01221441|182890142|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
91509138|NCT01221441|182890143|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated KOOS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for KOOS is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
91509139|NCT01221441|182890144|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated Lysholm score with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for Lysholm score is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
91509140|NCT03523117|182890156|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3108|TWO_SIDED||||||ANCOVA|||||||0.3108
91509141|NCT03523117|182890157|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
91509142|NCT03523117|182890158|SUPERIORITY||Mean Difference (Final Values)|15.64||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
91509143|NCT03523117|182890159|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
91533025|NCT04955626|182943200|OTHER||Difference in Percentages|5.4|||||TWO_SIDED|95.0|-3.0|13.8||||||Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||13.8|-3.0|
91533026|NCT04955626|182943207|OTHER||Geometric mean ratio (GMR)|2.23|||||TWO_SIDED|95.0|1.65|3.0||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.||3.00|1.65|
91755401|NCT03869333|183403908|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.009
91533027|NCT04955626|182943207|OTHER||Geometric mean ratio (GMR)|3.15|||||TWO_SIDED|95.0|2.38|4.16||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.||4.16|2.38|
91533028|NCT04955626|182943207|OTHER||Geometric mean ratio (GMR)|1.56|||||TWO_SIDED|95.0|1.17|2.08||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.||2.08|1.17|
91755402|NCT03869333|183403908|OTHER|||||||0.037|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.037
91755403|NCT03869333|183403908|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.009
91755404|NCT03869333|183403908|OTHER|||||||0.036|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.036
91755405|NCT03869333|183403908|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.042
91755406|NCT03869333|183403909|OTHER|||||||0.028|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.028
91755407|NCT03869333|183403909|OTHER|||||||0.088|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.088
91509144|NCT02915029|182890160|SUPERIORITY|The primary hypothesis being tested was that the intervention will increase patient activation.|Mean Difference (Net)|8.7||||0.01|TWO_SIDED|95.0|1.9|15.5|||ANCOVA|Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.|This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.|Group 1(usual care) is the comparison group, group 2 is the intervention group.|Applied generalized estimating equations (GEE) to account for within family (household) clustering.|15.5|1.9|0.01
91513424|NCT02328326|182898554|SUPERIORITY||Mean Difference (Net)|0.1||||0.67|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|Model was adjusted for baseline value of Lorig\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Lorig\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig\_CP score compared to patient participants in PACT.||0.55|-0.34|0.67
91513425|NCT02328326|182898555|SUPERIORITY||Mean Difference (Net)|0.28||||0.53|TWO_SIDED|95.0|-0.6|1.16|||Regression, Linear||Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.||1.16|-0.60|0.53
91755408|NCT03869333|183403909|OTHER|||||||0.146|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.146
91509145|NCT04452188|182890180|EQUIVALENCE|Prior studies suggest a 25-50% reduction in oxidative stress in normoxia relative to supra-physiologic oxygen. A 20% difference was considered clinically meaningful, and a sample size of 42 total participants was anticipated to achieve at least 80% power with a two-sided 5% significance level. However, an interim analysis recommended by the DSMB after enrollment of 29 patients revealed a significant difference in the primary outcome between the groups, and enrollment was thus stopped.|||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||Each participant's post-operative samples were normalized to their baseline sample and described as a fold-of-change from baseline.||||<0.01
91509146|NCT04452188|182890182|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the post-operative length of stay between the two groups.||||0.66
91509147|NCT04452188|182890183|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the days alive and out of ICU at 30 days since surgery between the two groups||||0.66
91509148|NCT04452188|182890184|OTHER|||||||1|||||||Fisher Exact|||||||1.00
91509149|NCT04452188|182890185|OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
91509150|NCT04452188|182890186|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
91509151|NCT04452188|182890187|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
91509152|NCT04452188|182890188|OTHER||||||<|0.1||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.1
91509153|NCT00357370|182890189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1898|||TWO_SIDED|95.0|-1.08|-0.32|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.32|-1.08|
91509154|NCT00357370|182890189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.1903|||TWO_SIDED|95.0|-1.16|-0.4|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.40|-1.16|
91509155|NCT00357370|182890190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.44|STANDARD_ERROR_OF_MEAN|11.4753|||TWO_SIDED|95.0|-38.37|7.48|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||7.48|-38.37|
91509156|NCT00357370|182890190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.44|STANDARD_ERROR_OF_MEAN|11.4574|||TWO_SIDED|95.0|-50.33|-4.55|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-4.55|-50.33|
91509157|NCT00357370|182890194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|3.8302|||TWO_SIDED|95.0|-10.69|4.6|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||4.60|-10.69|
91509158|NCT00357370|182890194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|3.8291|||TWO_SIDED|95.0|-10.17|5.12|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||5.12|-10.17|
91509159|NCT01502644|182890198|OTHER||Mean Difference (Net)|18.0||||0.01|TWO_SIDED|95.0|3.7|32.2|||Linear Mixed Modeling|Group, group×week, average baseline pain, and opioid use at baseline were entered as fixed effects using an autoregressive covariance structure.||||32.2|3.7|0.01
91509160|NCT03306264|182890211|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% confidence interval (CI) of the 5-day AUC0-24 ratio of Least Square Mean (LSM) for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.93|||||TWO_SIDED|90.0|92.66|105.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||105.6|92.66|
91509161|NCT03306264|182890211|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.64|||||TWO_SIDED|90.0|91.23|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.23|
91509162|NCT03306264|182890217|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.0|||||TWO_SIDED|90.0|91.8|104.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.6|91.80|
91533029|NCT04955626|182943207|OTHER||Geometric mean ratio (GMR)|1.97|||||TWO_SIDED|95.0|1.45|2.68||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.||2.68|1.45|
91755409|NCT03869333|183403909|OTHER|||||||0.126|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.126
91755410|NCT03869333|183403909|OTHER|||||||0.273|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.273
91755411|NCT03869333|183403911|OTHER|||||||0.348|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8||||0.348
91755412|NCT03869333|183403911|OTHER|||||||0.179|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29||||0.179
91755413|NCT03869333|183403911|OTHER|||||||0.089|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.089
91755414|NCT02598128|183403914|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).||||||<0.001
91509163|NCT03306264|182890217|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.61|||||TWO_SIDED|90.0|91.2|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.20|
91509164|NCT03306264|182890218|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|91.88|104.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.8|91.88|
91509165|NCT03306264|182890218|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|89.75|107.2|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||107.2|89.75|
91509166|NCT03306264|182890219|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.93|||||TWO_SIDED|90.0|91.74|104.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.5|91.74|
91509167|NCT03306264|182890219|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.55|||||TWO_SIDED|90.0|89.32|106.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||106.5|89.32|
91509168|NCT00554749|182890239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.09|STANDARD_DEVIATION|0.43|<|0.001||95.0|1.69|2.49|||paired t-test|Paired t-test of SSQ at baseline vs at 6 months, degrees of freedom=6. Difference in SSQ is reported.||||2.49|1.69|<0.001
91509169|NCT00094653|182890248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.85|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.85|0.55|0.0004
91509170|NCT00094653|182890249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0026|TWO_SIDED|95.0|0.51|0.87|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.87|0.51|0.0026
91509171|NCT00094653|182890249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7575|TWO_SIDED|95.0|0.83|1.3|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.30|0.83|0.7575
91509172|NCT00094653|182890251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
91509173|NCT00094653|182890251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
91509174|NCT00094653|182890251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
91509175|NCT00094653|182890253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
91509176|NCT00094653|182890253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
91509177|NCT00094653|182890253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
91533030|NCT04955626|182943208|OTHER||Difference in percentages|19.6|||||TWO_SIDED|95.0|9.3|29.7||||||Difference in proportions, expressed as a percentage (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||29.7|9.3|
91509178|NCT00094653|182890255|SUPERIORITY_OR_OTHER|||||||0.0433||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0433
91509179|NCT00094653|182890255|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0012
91509180|NCT00094653|182890255|SUPERIORITY_OR_OTHER|||||||0.0402||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0402
91509181|NCT00094653|182890258|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0179
91509182|NCT00094653|182890258|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0002
91509183|NCT00094653|182890258|SUPERIORITY_OR_OTHER|||||||0.0429||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0429
91509184|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.2805|TWO_SIDED|95.0|-2.5|8.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.6|-2.5|0.2805
91509185|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.63|TWO_SIDED|95.0|-5.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.2|-5.0|0.6300
91509186|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6026|TWO_SIDED|95.0|-3.9|6.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||6.8|-3.9|0.6026
91509187|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.1219|TWO_SIDED|95.0|-1.1|8.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||8.9|-1.1|0.1219
91509188|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0||||0.0978|TWO_SIDED|95.0|-0.9|11.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||11.0|-0.9|0.0978
91509189|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.659|TWO_SIDED|95.0|-6.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||3.8|-6.0|0.6590
91533031|NCT04955626|182943208|OTHER||Difference in Percentages|29.1|||||TWO_SIDED|95.0|19.4|38.5||||||Difference in proportions, expressed as a percentage (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||38.5|19.4|
91755415|NCT01378429|183403916|NON_INFERIORITY_OR_EQUIVALENCE|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|LS Mean Difference|7.6|||||TWO_SIDED|95.0|-7.4|22.6||\<0.025 for a one-sided test.|ANCOVA||Difference is calculated as Placebo - Ciclesonide.|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.||22.6|-7.4|
91533032|NCT04955626|182943208|OTHER||Difference in percentages|14.6|||||TWO_SIDED|95.0|4.0|24.9||||||Difference in proportions, expressed as a percentage (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||24.9|4.0|
91533033|NCT04955626|182943208|OTHER||Difference in Percentages|10.9|||||TWO_SIDED|95.0|0.1|21.4||||||Difference in proportions, expressed as a percentage (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 μg\]). 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||21.4|0.1|
91533034|NCT04955626|182943216|OTHER||Geometric mean ratio (GMR)|0.79|||||TWO_SIDED|95.0|0.4|1.56||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.56|0.40|
91755416|NCT01064687|183403933|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.22|-0.88||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.88|-1.22|<0.001
91755417|NCT01064687|183403933|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.66|<0.0001
91509190|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.248|TWO_SIDED|95.0|-3.0|11.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||11.7|-3.0|0.2480
91533035|NCT04955626|182943216|OTHER||Geometric mean ratio (GMR)|1.78|||||TWO_SIDED|95.0|0.93|3.43||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.43|0.93|
91533036|NCT04955626|182943216|OTHER||Geometric mean ratio (GMR)|2.35|||||TWO_SIDED|95.0|1.22|4.55||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||4.55|1.22|
91755418|NCT01064687|183403933|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.01|-0.67||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.67|-1.01|<0.001
91755419|NCT01064687|183403933|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.66|<0.001
91755420|NCT01064687|183403933|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.18|-0.44|<0.001
91755421|NCT01064687|183403933|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.18|-0.44|<0.001
91755422|NCT01064687|183403934|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.73|<0.001
91755423|NCT01064687|183403934|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.11|-0.44|<0.001
91755424|NCT01064687|183403934|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.73|<0.001
91755425|NCT01064687|183403934|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.11|-0.44|<0.001
91755426|NCT01064687|183403935|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.72|||<|0.001|TWO_SIDED|95.0|-3.58|-1.85|||Mixed Models Analysis|||||-1.85|-3.58|<0.001
91533037|NCT04955626|182943216|OTHER||Geometric mean ratio (GMR)|1.49|||||TWO_SIDED|95.0|0.76|2.89||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\]- BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.89|0.76|
91755427|NCT01064687|183403935|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.571|TWO_SIDED|95.0|-0.88|0.49|||Mixed Models Analysis|||||0.49|-0.88|0.571
91755428|NCT01064687|183403935|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19||||0.007|TWO_SIDED|95.0|-2.06|-0.33|||Mixed Models Analysis|||||-0.33|-2.06|0.007
91755429|NCT01064687|183403935|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|||<|0.001|TWO_SIDED|95.0|0.64|2.01|||Mixed Models Analysis|||||2.01|0.64|<0.001
91533038|NCT04955626|182943216|OTHER||Geometric mean ratio (GMR)|2.33|||||TWO_SIDED|95.0|1.2|4.53||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||4.53|1.20|
91755430|NCT01064687|183403935|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.52|||<|0.001|TWO_SIDED|95.0|-3.39|-1.65|||Mixed Models Analysis|||||-1.65|-3.39|<0.001
91755431|NCT01064687|183403936|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.507|TWO_SIDED|95.0|-1.25|0.62|||Mixed Models Analysis|||||0.62|-1.25|0.507
91755432|NCT01064687|183403936|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.009|TWO_SIDED|95.0|0.32|2.19|||Mixed Models Analysis|||||2.19|0.32|0.009
91755433|NCT01064687|183403937|SUPERIORITY_OR_OTHER||LS Means Difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.27|-0.67|||Mixed Models Analysis|||||-0.67|-1.27|<0.001
91755434|NCT01064687|183403937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.568|TWO_SIDED|95.0|-0.31|0.17|||Mixed Models Analysis|||||0.17|-0.31|0.568
91755435|NCT01064687|183403937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Models Analysis|||||-0.12|-0.72|0.006
91755436|NCT01064687|183403937|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.24|0.71|||Mixed Models Analysis|||||0.71|0.24|<0.001
91755437|NCT01064687|183403937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||||-0.60|-1.20|<0.001
91755438|NCT01064687|183403938|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.58|TWO_SIDED|95.0|-0.42|0.23|||Mixed Models Analysis|||||0.23|-0.42|0.580
91755439|NCT01064687|183403938|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.005|TWO_SIDED|95.0|0.14|0.79|||Mixed Models Analysis|||||0.79|0.14|0.005
91755440|NCT01064687|183403939|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.76|||<|0.001|TWO_SIDED|95.0|-34.5|-23.02|||Mixed Models Analysis|||||-23.02|-34.50|<0.001
91755441|NCT01064687|183403939|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.34|||<|0.001|TWO_SIDED|95.0|-13.62|-5.06|||Mixed Models Analysis|||||-5.06|-13.62|<0.001
91755442|NCT01064687|183403939|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.02|||<|0.001|TWO_SIDED|95.0|-29.8|-18.24|||Mixed Models Analysis|||||-18.24|-29.80|<0.001
91755443|NCT01064687|183403939|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61||||0.038|TWO_SIDED|95.0|-8.95|-0.27|||Mixed Models Analysis|||||-0.27|-8.95|0.038
91755444|NCT01064687|183403939|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.41|||<|0.001|TWO_SIDED|95.0|-25.18|-13.65|||Mixed Models Analysis|||||-13.65|-25.18|<0.001
91755445|NCT01064687|183403940|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.68||||0.004|TWO_SIDED|95.0|-12.84|-2.52|||Mixed Models Analysis|||||-2.52|-12.84|0.004
91509191|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.4742|TWO_SIDED|95.0|-5.6|12.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||12.0|-5.6|0.4742
91509192|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.7597|TWO_SIDED|95.0|-6.1|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||8.3|-6.1|0.7597
91509193|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9119|TWO_SIDED|95.0|-4.7|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.2|-4.7|0.9119
91509194|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7616|TWO_SIDED|95.0|-6.9|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.0|-6.9|0.7616
91509195|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.6266|TWO_SIDED|95.0|-3.6|6.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||6.0|-3.6|0.6266
91509196|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9984|TWO_SIDED|95.0|-4.8|4.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||4.8|-4.8|0.9984
91509197|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4873|TWO_SIDED|95.0|-7.8|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||3.7|-7.8|0.4873
91509198|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.3938|TWO_SIDED|95.0|-2.7|6.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||6.7|-2.7|0.3938
91533039|NCT04955626|182943217|OTHER||Geometric mean ratio (GMR)|0.76|||||TWO_SIDED|95.0|0.4|1.42||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.42|0.40|
91755446|NCT01064687|183403940|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.092|TWO_SIDED|95.0|-9.66|0.73|||Mixed Models Analysis|||||0.73|-9.66|0.092
91755447|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|23.4||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||23.4|7.4|<0.001
91755448|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|3.9|10.1||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||10.1|3.9|<0.001
91755449|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.001|TWO_SIDED|95.0|2.8|8.0||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||8.0|2.8|<0.001
91509199|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.6695|TWO_SIDED|95.0|-8.1|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||5.2|-8.1|0.6695
91509200|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.4041|TWO_SIDED|95.0|-11.3|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||4.6|-11.3|0.4041
91755450|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.5|<0.001
91755451|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.004|TWO_SIDED|95.0|1.3|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.3|0.004
91755452|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|6.7|20.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||20.8|6.7|<0.001
91755453|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||6.8|2.9|<0.001
91755454|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||<|0.001|TWO_SIDED|95.0|3.7|10.9||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||10.9|3.7|<0.001
91755455|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.6|3.5||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.5|1.6|<0.001
91755456|NCT01064687|183403941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.6|4.6||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||4.6|1.6|<0.001
91755457|NCT01064687|183403942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|2.4|5.6||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||5.6|2.4|<0.001
91509201|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.5538|TWO_SIDED|95.0|-4.5|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||8.3|-4.5|0.5538
91509202|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.2259|TWO_SIDED|95.0|-10.3|2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||2.4|-10.3|0.2259
91533040|NCT04955626|182943217|OTHER||Geometric mean ratio (GMR)|0.86|||||TWO_SIDED|95.0|0.47|1.58||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.58|0.47|
91533041|NCT04955626|182943217|OTHER||Geometric mean ratio (GMR)|1.06|||||TWO_SIDED|95.0|0.57|1.95||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.95|0.57|
91755458|NCT01064687|183403942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.008|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||2.5|1.1|0.008
91755459|NCT01064687|183403942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.3|5.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||5.1|2.3|<0.001
91755460|NCT01064687|183403942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.4|3.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.1|1.4|<0.001
91755461|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|35.21|||<|0.001|TWO_SIDED|95.0|27.26|43.16||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||43.16|27.26|<0.001
91755462|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|21.12|||<|0.001|TWO_SIDED|95.0|14.97|27.28||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||27.28|14.97|<0.001
91755463|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|22.68|||<|0.001|TWO_SIDED|95.0|14.63|30.72||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||30.72|14.63|<0.001
91755464|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|8.59||||0.007|TWO_SIDED|95.0|2.31|14.87||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||14.87|2.31|0.007
91755465|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|14.09|||<|0.001|TWO_SIDED|95.0|6.06|22.11||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||22.11|6.06|<0.001
91755466|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7||||0.207|TWO_SIDED|95.0|-14.56|3.17||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.17|-14.56|0.207
91755467|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.659|TWO_SIDED|95.0|-8.41|5.32||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.32|-8.41|0.659
91755468|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.759|TWO_SIDED|95.0|-10.37|7.56||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||7.56|-10.37|0.759
91755469|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|2.75||||0.441|TWO_SIDED|95.0|-4.25|9.76||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||9.76|-4.25|0.441
91755470|NCT01064687|183403943|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.15||||0.362|TWO_SIDED|95.0|-13.1|4.79||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||4.79|-13.10|0.362
91755471|NCT01064687|183403944|SUPERIORITY_OR_OTHER||LS Mean Difference|21.64|||<|0.001|TWO_SIDED|95.0|15.2|28.08||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||28.08|15.20|<0.001
91755472|NCT01064687|183403944|SUPERIORITY_OR_OTHER||LS Mean Difference|12.12|||<|0.001|TWO_SIDED|95.0|5.56|18.68||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||18.68|5.56|<0.001
91755473|NCT01064687|183403944|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73||||0.307|TWO_SIDED|95.0|-10.9|3.43||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.43|-10.90|0.307
91755474|NCT01064687|183403944|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75||||0.638|TWO_SIDED|95.0|-9.05|5.55||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.55|-9.05|0.638
91755475|NCT02265796|183403991|SUPERIORITY||||||>|0.05||||||the reported p value is for all between group comparisons of the SAQ domains.|t-test, 2 sided|||between group comparison for all SAQ domains||||>0.05
91755476|NCT02265796|183403991|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation, angina frequency and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
91755477|NCT02265796|183403991|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
91755478|NCT02265796|183403991|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
91755479|NCT02265796|183403991|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability, angina frequency and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
91755480|NCT02265796|183403992|SUPERIORITY|||||||0.58|||||||Fisher Exact|||"between group comparison for the excellent/good"||||0.58
91755481|NCT02265796|183403992|SUPERIORITY|||||||0.8|||||||Fisher Exact|||"Between group analysis for fair/poor"||||0.80
91755482|NCT02265796|183403992|SUPERIORITY|||||||0.5|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.50
91509203|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.6168|TWO_SIDED|95.0|-9.6|5.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||5.7|-9.6|0.6168
91509204|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.5329|TWO_SIDED|95.0|-8.2|4.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||4.3|-8.2|0.5329
91509205|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9397|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||5.0|-4.7|0.9397
91509206|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.6716|TWO_SIDED|95.0|-7.1|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||4.6|-7.1|0.6716
91509207|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.5497|TWO_SIDED|95.0|-3.3|6.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||6.2|-3.3|0.5497
91509208|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.0625|TWO_SIDED|95.0|-12.8|0.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||0.3|-12.8|0.0625
91509209|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.3214|TWO_SIDED|95.0|-11.9|3.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||3.9|-11.9|0.3214
91755483|NCT02265796|183403992|SUPERIORITY|||||||0.48|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.48
91755484|NCT02265796|183403992|SUPERIORITY|||||||0.19|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.19
91755485|NCT02265796|183403992|SUPERIORITY|||||||0.067|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.067
91509210|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.4898|TWO_SIDED|95.0|-8.7|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||4.2|-8.7|0.4898
91509211|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0761|TWO_SIDED|95.0|-11.8|0.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||0.6|-11.8|0.0761
91509212|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.3187|TWO_SIDED|95.0|-11.2|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||3.7|-11.2|0.3187
91509213|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.5548|TWO_SIDED|95.0|-7.9|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||4.2|-7.9|0.5548
91755486|NCT02265796|183403993|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91755487|NCT00377364|183404077|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline RAVLT scores used as covariate.||||<0.05
91509214|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.245|TWO_SIDED|95.0|-12.1|3.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||3.1|-12.1|0.2450
91755488|NCT00377364|183404080|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ISS scores used as a covariate. ANCOVA results were not significant.||||||<0.05
91755489|NCT00377364|183404081|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline HRSD scores used as a covariate.||||<0.05
91755490|NCT00377364|183404083|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Baseline YMRS scores used as a covariate.||||||0.05
91755491|NCT00377364|183404085|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ACQ scores used as a covariate.||||||<0.05
91755492|NCT03480009|183404088|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
91755493|NCT03480009|183404088|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
91755494|NCT03480009|183404089|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.81
91755495|NCT03480009|183404089|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||acetaminophen||||.24
91755496|NCT03480009|183404089|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||oxycodone||||.54
91755497|NCT03480009|183404089|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.61
91755498|NCT03480009|183404089|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Acetaminophen||||.24
91755499|NCT03480009|183404090|OTHER|||||||0.99|||||||Wald Chi Square|Wald Chi Square from mixed effects linear regression||||||.99
91755500|NCT03480009|183404090|OTHER|||||||0.56|||||||Wald Chi Square|P-value from Wald chi-square from mixed effects linear regression||||||.56
91509215|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8464|TWO_SIDED|95.0|-10.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||8.2|-10.0|0.8464
91509216|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.3351|TWO_SIDED|95.0|-10.9|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep Disturbance change from baseline||3.7|-10.9|0.3351
91509217|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.6291|TWO_SIDED|95.0|-9.1|5.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite loss change from baseline||5.5|-9.1|0.6291
91509218|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.7675|TWO_SIDED|95.0|-7.4|10.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||10.1|-7.4|0.7675
91509219|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.3911|TWO_SIDED|95.0|-10.2|4.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||4.0|-10.2|0.3911
91509220|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0431|TWO_SIDED|95.0|-12.9|-0.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-0.2|-12.9|0.0431
91509221|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.0101|TWO_SIDED|95.0|-17.4|-2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-2.4|-17.4|0.0101
91509222|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.2796|TWO_SIDED|95.0|-2.8|9.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||9.5|-2.8|0.2796
91509223|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.194|TWO_SIDED|95.0|-2.2|10.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||10.8|-2.2|0.1940
91755501|NCT03480009|183404091|OTHER|||||||0.07|||||||Fisher Exact|||||||.07
91509224|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0821|TWO_SIDED|95.0|-0.9|14.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||14.8|-0.9|0.0821
91509225|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.4169|TWO_SIDED|95.0|-9.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||3.8|-9.0|0.4169
91533042|NCT04955626|182943217|OTHER||Geometric mean ratio (GMR)|1.13|||||TWO_SIDED|95.0|0.61|2.09||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.09|0.61|
91533043|NCT04955626|182943217|OTHER||Geometric mean ratio (GMR)|1.35|||||TWO_SIDED|95.0|0.73|2.5||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.50|0.73|
91755502|NCT03480009|183404091|OTHER|||||||0.5|||||||Fisher Exact|||||||.50
91755503|NCT02014584|183404107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.27|TWO_SIDED|95.0|-4.7|18.8|||Fisher's Exact Test|||||18.8|-4.7|0.27
91509226|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.5717|TWO_SIDED|95.0|-7.5|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||4.2|-7.5|0.5717
91509227|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6949|TWO_SIDED|95.0|-5.6|8.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||8.4|-5.6|0.6949
91755504|NCT02014584|183404153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.5||||0.62|TWO_SIDED|95.0|-10.4|3.4|||Fisher's Exact Test||DB Week 4|||3.4|-10.4|0.62
91755505|NCT02014584|183404153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.4||||0.34|TWO_SIDED|95.0|-4.7|17.6|||Fisher's Exact Test||DB Week 12|||17.6|-4.7|0.34
91755506|NCT02014584|183404153|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.31|TWO_SIDED|95.0|-4.2|16.7|||Fisher's Exact Test||DB Week 24|||16.7|-4.2|0.31
91509228|NCT00094653|182890260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2849|TWO_SIDED|95.0|-8.8|2.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||2.6|-8.8|0.2849
91509229|NCT00330551|182890267|SUPERIORITY||t-test|0.77|||=|0.05|TWO_SIDED|95.0|0.483|1.058|||t-test, 2 sided||||t(80)=5.3, p\<.001|1.058|0.483|=.05
91509230|NCT00330551|182890268|SUPERIORITY||Risk Difference (RD)|11.1|||=|0.001|TWO_SIDED||||||Chi-squared|||||||=.001
91509231|NCT00330551|182890269|SUPERIORITY||||||=|0.83|||||||Chi-squared|||||||=.83
91509232|NCT00330551|182890270|SUPERIORITY||||||=|0.2|||||||ANOVA|||A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.||||=.20
91509233|NCT00330551|182890271|SUPERIORITY|||||||0.71|||||||ANOVA|||||||.71
91509234|NCT00330551|182890272|SUPERIORITY||||||=|0.57|||||||ANOVA|||||||=.57
91509235|NCT00330551|182890274|SUPERIORITY||||||<|0.16|||||||ANOVA|||||||<.16
91509236|NCT00330551|182890275|SUPERIORITY||||||=|0.41|||||||ANOVA|||||||=.41
91509237|NCT06561217|182890299|NON_INFERIORITY|A predefined non-inferiority margin of 0.05 was used. The primary study was powered on a retrospective, paired, non-inferiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02|||<|0.001|ONE_SIDED|95.0|0.00007515||||Wilcoxon (Mann-Whitney)||The upper bound of the 95% confidence interval is Inf due to the test being one-sided. Alternative hypothesis: true median location shift is greater than -0.05|A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the primary null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was non-inferior to the chart-level accuracy of a Human-alone arm abstraction by at least 5% (i.e., noninferiority margin).|||0.00007515|<0.001
91509238|NCT06561217|182890299|SUPERIORITY|The primary study was powered on a retrospective, paired, superiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was superior to the chart-level accuracy of a Human-alone arm abstraction.||||0.002
91755507|NCT02014584|183404155|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.082|TWO_SIDED|95.0|-0.2|3.0|||t-test from general linear model||DB Week 4|||3.0|-0.2|0.082
91509239|NCT06561217|182890300|EQUIVALENCE|Null hypothesis: True difference is equal to 0. Alternate hypothesis: true difference is not equal to 0|Median Difference (Final Values)|0.66||||0.513|TWO_SIDED|95.0|-1.25|2.55|||Wilcoxon (Mann-Whitney)|||A two-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test for difference between chart-level efficiency of the Human+AI arm and chart-level efficiency of the Human-alone arm abstraction.||2.55|-1.25|0.513
91509240|NCT04552587|182890341|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||We compared change from baseline to follow up in our single group of caregivers.||||0.23
91509241|NCT01393743|182890367|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-30.81||||0.0001|TWO_SIDED|95.0|-45.49|-15.244||The P-value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-15.244|-45.49|0.0001
91755508|NCT02014584|183404155|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.09||0.25|TWO_SIDED|95.0|-3.4|0.9|||t-test from general linear model||DB Week 12|||0.9|-3.4|0.25
91509242|NCT01393743|182890368|SUPERIORITY_OR_OTHER|||||||0.0019||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.0019
91509243|NCT01393743|182890370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.45||||0.0018|TWO_SIDED|95.0|-40.668|-8.518||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-8.518|-40.668|0.0018
91509244|NCT01393743|182890371|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.25||||0.3478|TWO_SIDED|95.0|-53.054|26.989||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|Median Difference to Placebo for Absence Seizures||26.989|-53.054|0.3478
91509245|NCT01393743|182890371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.87||||0.61|TWO_SIDED|95.0|-15.338|59.938|||ANCOVA|||Median Difference to Placebo for Myoclonic Seizure||59.938|-15.338|0.61
91509246|NCT01393743|182890372|SUPERIORITY_OR_OTHER|||||||0.1826||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.1826
91509247|NCT01393743|182890373|SUPERIORITY_OR_OTHER|||||||0.4653|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Absence Seizures||||0.4653
91755509|NCT02014584|183404155|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.04||0.99|TWO_SIDED|95.0|-2.0|2.1|||t-test from general linear model||DB Week 24|||2.1|-2.0|0.99
91509248|NCT01393743|182890373|SUPERIORITY_OR_OTHER|||||||0.3694|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Myoclonic Seizures||||0.3694
91755510|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.46|TWO_SIDED|95.0|-0.4|0.9|||t-test from general linear model||Erectile Function DB Week 4|||0.9|-0.4|0.46
91755511|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.52||0.14|TWO_SIDED|95.0|-1.8|0.3|||t-test from general linear model||Erectile Function DB Week 12|||0.3|-1.8|0.14
91509249|NCT05409235|182890377|SUPERIORITY||difference in percentage of participants|-1.064||||0.573|TWO_SIDED|90.0|-10.578|8.449|||Mantel Haenszel|MH test is adjusted for the randomization stratification factor (Screening DRSS score 47 or 53 or 61B).|A single imputation (non-response) when applying composite variable strategy. MI based for missing data at Week 24, assuming MAR when applying hypothetical strategy. Kept in the analysis when applying treatment policy strategy.|The study was powered to provide a 90% probability to detect a 20% difference between each treatment arm and the combined vehicle control.||8.449|-10.578|0.5730
91509250|NCT05409235|182890377|SUPERIORITY||difference in percentage of participants|-1.152||||0.575|TWO_SIDED|90.0|-11.178|8.874|||Mantel Haenszel|||||8.874|-11.178|0.5750
91509251|NCT05409235|182890378|SUPERIORITY||difference in percentage of participants|3.119||||0.7276|TWO_SIDED|90.0|-5.314|11.592|||Mantel Haenszel|||||11.592|-5.314|0.7276
91509252|NCT05409235|182890378|SUPERIORITY||difference in percentage of participants|5.779||||0.8492|TWO_SIDED|90.0|-3.424|14.982|||Mantel Haenszel|||||14.982|-3.424|0.8492
91509253|NCT05409235|182890379|SUPERIORITY||difference in percentage of participants|-1.863||||0.3097|TWO_SIDED|90.0|-8.036|4.309|||Mantel Haenszel|||||4.309|-8.036|0.3097
91509254|NCT05409235|182890379|SUPERIORITY||difference in percentage of participants|-1.596||||0.3414|TWO_SIDED|90.0|-8.021|4.829|||Mantel Haenszel|||||4.829|-8.021|0.3414
91509255|NCT05409235|182890380|SUPERIORITY||Cox Proportional Hazard|0.899||||0.397|TWO_SIDED|90.0|0.4378|1.8467|||Log Rank|||||1.8467|0.4378|0.397
91509256|NCT05409235|182890380|SUPERIORITY||Cox Proportional Hazard|1.113||||0.605|TWO_SIDED|90.0|0.5596|2.2117|||Log Rank|||||2.2117|0.5596|0.605
91755512|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.27|TWO_SIDED|95.0|-1.9|0.5|||t-test from general linear model||Erectile Function DB Week 24|||0.5|-1.9|0.27
91755513|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.13|TWO_SIDED|95.0|-0.1|0.8|||t-test from general linear model||Intercourse satisfaction DB Week 4|||0.8|-0.1|0.13
91509257|NCT05409235|182890381|SUPERIORITY||difference in percentage of participants|-10.622||||0.0619|TWO_SIDED|90.0|-21.972|0.728|||Mantel Haenszel|||||0.728|-21.972|0.0619
91509258|NCT05409235|182890381|SUPERIORITY||difference in percentage of participants|-4.942||||0.2483|TWO_SIDED|90.0|-16.897|7.013|||Mantel Haenszel|||||7.013|-16.897|0.2483
91509259|NCT05409235|182890382|SUPERIORITY||Cox Proportional Hazard|0.807||||0.237|TWO_SIDED|90.0|0.4675|1.392|||Log Rank|||||1.3920|0.4675|0.237
91509260|NCT05409235|182890382|SUPERIORITY||Cox Proportional Hazard|1.279||||0.766|TWO_SIDED|90.0|0.7795|2.0981|||Log Rank|||||2.0981|0.7795|0.766
91509261|NCT05409235|182890383|SUPERIORITY||difference in percentage of participants|-6.389||||0.2022|TWO_SIDED|90.0|-18.994|6.215|||Mantel Haenszel|||||6.215|-18.994|0.2022
91509262|NCT05409235|182890383|SUPERIORITY||difference in percentage of participants|-1.043||||0.4476|TWO_SIDED|90.0|-14.07|11.984|||Mantel Haenszel|||||11.984|-14.070|0.4476
91509263|NCT05409235|182890384|SUPERIORITY||Hazard Ratio (HR)|0.843||||0.268|TWO_SIDED|90.0|0.533|1.334||log-rank test stratified by randomization stratification factor|Log Rank|||||1.334|0.533|0.268
91755514|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.73|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 12|||0.5|-0.8|0.73
91509264|NCT05409235|182890384|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.304|TWO_SIDED|90.0|0.738|1.775|||Log Rank|||||1.775|0.738|0.304
91509265|NCT05409235|182890385|SUPERIORITY||Odds Ratio (OR)|1.102||||0.428|TWO_SIDED|90.0|0.4573|2.657|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.6570|0.4573|0.428
91755515|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.64|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 24|||0.5|-0.8|0.64
91509266|NCT05409235|182890385|SUPERIORITY||Odds Ratio (OR)|1.119||||0.419|TWO_SIDED|90.0|0.45|2.7846|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.7846|0.4500|0.419
91509267|NCT05409235|182890386|SUPERIORITY||difference in percentage of participants|-1.544||||0.6716|TWO_SIDED|90.0|-7.26|4.172|||Mantel Haenszel|||||4.172|-7.260|0.6716
91509268|NCT05409235|182890386|SUPERIORITY||difference in percentage of participants|-3.412||||0.8414|TWO_SIDED|90.0|-9.025|2.2|||Mantel Haenszel|||||2.200|-9.025|0.8414
91509269|NCT05409235|182890387|SUPERIORITY||Mean Difference (Net)|-0.5325||||0.647|TWO_SIDED|90.0|-2.8478|1.7827|||ANCOVA|||||1.7827|-2.8478|0.647
91509270|NCT05409235|182890387|SUPERIORITY||Mean Difference (Net)|-2.2849||||0.945|TWO_SIDED|90.0|-4.6356|0.0658|||ANCOVA|||||0.0658|-4.6356|0.945
91509271|NCT05409235|182890388|SUPERIORITY||Odds Ratio (OR)|1.108||||0.367|TWO_SIDED|90.0|0.6722|1.8276|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.8276|0.6722|0.367
91509272|NCT05409235|182890388|SUPERIORITY||Odds Ratio (OR)|0.717||||0.857|TWO_SIDED|90.0|0.4295|1.1981|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.1981|0.4295|0.857
91509273|NCT05409235|182890389|SUPERIORITY||Mean Difference (Net)|4.1531||||0.437|TWO_SIDED|90.0|-38.793|47.0991|||ANCOVA|||||47.0991|-38.7930|0.437
91509274|NCT05409235|182890389|SUPERIORITY||Mean Difference (Net)|-16.2461||||0.733|TWO_SIDED|90.0|-59.2538|26.7616|||ANCOVA|||||26.7616|-59.2538|0.733
91509275|NCT05409235|182890390|SUPERIORITY||Mean Difference (Net)|4.0634||||0.77|TWO_SIDED|90.0|-4.9712|13.098|||ANCOVA|||||13.0980|-4.9712|0.770
91509276|NCT05409235|182890390|SUPERIORITY||Mean Difference (Net)|-1.0507||||0.424|TWO_SIDED|90.0|-10.1046|8.0032|||ANCOVA|||||8.0032|-10.1046|0.424
91509277|NCT05409235|182890391|SUPERIORITY||Mean Difference (Net)|0.0205||||0.606|TWO_SIDED|90.0|-0.1043|0.1452|||ANCOVA|||||0.1452|-0.1043|0.606
91755516|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|-0.1|0.5|||t-test from general linear model||Orgasmic function DB Week 4|||0.5|-0.1|0.23
91755517|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|-0.5|0.2|||t-test from general linear model||Orgasmic function DB Week 12|||0.2|-0.5|0.33
91755518|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23||0.64|TWO_SIDED|95.0|-0.6|0.3|||t-test from general linear model||Orgasmic function DB Week 24|||0.3|-0.6|0.64
91509278|NCT05409235|182890391|SUPERIORITY||Mean Difference (Net)|0.0083||||0.544|TWO_SIDED|90.0|-0.1161|0.1326|||ANCOVA|||||0.1326|-0.1161|0.544
91509279|NCT05409235|182890392|SUPERIORITY||difference in percentage of participants|-1.544||||0.406|TWO_SIDED|90.0|-12.247|9.158|||Mantel Haenszel|||||9.158|-12.247|0.406
91509280|NCT05409235|182890392|SUPERIORITY||difference in percentage of participants|1.763||||0.605|TWO_SIDED|90.0|-9.114|12.64|||Mantel Haenszel|||||12.640|-9.114|0.605
91509281|NCT05409235|182890393|SUPERIORITY||Hazard Ratio (HR)|0.916||||0.404|TWO_SIDED|90.0|0.5068|1.6556|||Log Rank|||||1.6556|0.5068|0.404
91755519|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|95.0|-0.1|0.7|||t-test from general linear model||Sexual desire DB Week 4|||0.7|-0.1|0.19
91755520|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.28|TWO_SIDED|95.0|-0.7|0.2|||t-test from general linear model||Sexual desire DB Week 12|||0.2|-0.7|0.28
91755521|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||1|TWO_SIDED|95.0|-0.5|0.5|||t-test from general linear model||Sexual desire DB Week 24|||0.5|-0.5|1.00
91755522|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.28|TWO_SIDED|95.0|-0.2|0.5|||t-test from general linear model||Overall sexual satisfaction DB Week 4|||0.5|-0.2|0.28
91755523|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.64|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 12|||0.3|-0.5|0.64
91755524|NCT02014584|183404157|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.69|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 24|||0.3|-0.5|0.69
91755525|NCT02014584|183404159|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|1.14||0.33|TWO_SIDED|95.0|-1.1|3.4|||t-test from general linear model||DB Week 12|||3.4|-1.1|0.33
91755526|NCT02014584|183404159|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.14||0.004|TWO_SIDED|95.0|1.1|5.6|||t-test from general linear model||DB Week 24|||5.6|1.1|0.004
91755527|NCT02014584|183404161|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.22|TWO_SIDED|95.0|-1.7|0.4|||t-test from general linear model||DB Week 12|||0.4|-1.7|0.22
91755528|NCT02014584|183404161|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.76||0.5|TWO_SIDED|95.0|-2.0|1.0|||t-test from general linear model||DB Week 24|||1.0|-2.0|0.50
91755529|NCT02651220|183404173|EQUIVALENCE|Bioequivalence was based on 90% confidence interval within 80-125%.|Bioavailability|100.28|||||TWO_SIDED|90.0|96.78|103.91||||||||103.91|96.78|
91755530|NCT02651220|183404174|EQUIVALENCE|Bioequivalence is based on 90% confidence interval within 80-125%.|Bioavailability|99.73|||||TWO_SIDED|90.0|96.04|103.56||||||||103.56|96.04|
91755531|NCT02651220|183404175|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91755532|NCT01439373|183404182|OTHER||Mean posterior difference|0.46|STANDARD_DEVIATION|0.119|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.905. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.22 to 0.68.|||||
91755533|NCT01439373|183404183|OTHER||Mean posterior difference|0.41|STANDARD_DEVIATION|0.122|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.822. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.17 to 0.6|||||
91755534|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.33|0.75|
91509282|NCT05409235|182890393|SUPERIORITY||Hazard Ratio (HR)|1.128||||0.624|TWO_SIDED|90.0|0.6399|1.9868|||Log Rank|||||1.9868|0.6399|0.624
91509283|NCT05409235|182890394|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.478|TWO_SIDED|90.0|0.2473|3.6295|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor.||||3.6295|0.2473|0.478
91755535|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.24|1.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.94|1.24|
91755536|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.74|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.41|0.74|
91755537|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.01|2.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.00|1.01|
91509284|NCT05409235|182890394|SUPERIORITY||Hazard Ratio (HR)|1.296||||0.631|TWO_SIDED|90.0|0.3688|4.5512|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor||||4.5512|0.3688|0.631
91509285|NCT05409235|182890395|SUPERIORITY||difference in percentage of participants|-13.7727||||0.045|TWO_SIDED|90.0|-27.1319|-0.4134|||Mantel Haenszel|||||-0.4134|-27.1319|0.0450
91509286|NCT05409235|182890395|SUPERIORITY||difference in percentage of participants|-3.8234||||0.3304|TWO_SIDED|90.0|-18.1549|10.5081|||Mantel Haenszel|||||10.5081|-18.1549|0.3304
91509287|NCT05409235|182890396|SUPERIORITY||difference in percentage of participants|-14.8877||||0.0275|TWO_SIDED|90.0|-27.6462|-2.1293|||Mantel Haenszel|||||-2.1293|-27.6462|0.0275
91509288|NCT05409235|182890396|SUPERIORITY||difference in percentage of participants|-7.5535||||0.179|TWO_SIDED|90.0|-21.0688|5.9617|||Mantel Haenszel|||||5.9617|-21.0688|0.1790
91509289|NCT03080961|182890440|OTHER||SADE percentage|0.0|||||TWO_SIDED|95.0|0.0|7.7||||||SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.||7.7|0.0|
91509290|NCT03080961|182890441|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.||||0.248
91509291|NCT03080961|182890442|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91759820|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.32|||||TWO_SIDED|95.0|-3.25|0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-3.25|
91509292|NCT00445328|182890471|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is based on chi-square test with alpha as 0.01.|Chi-squared|||||||1.0000
91509293|NCT00445328|182890473|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Chi-squared|||Major Bleeding||||1.0000
91509294|NCT00445328|182890476|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Chi-squared|||||||0.1355
91533044|NCT04955626|182943218|OTHER||Geometric mean ratio (GMR)|0.95|||||TWO_SIDED|95.0|0.58|1.56||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.56|0.58|
91509295|NCT00457197|182890556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||ANCOVA|||Baseline drinks/day used as covariate.||||0.4709
91509296|NCT00457197|182890557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1272|TWO_SIDED||||||ANCOVA|||Baseline percent heavy drinking days included as covariate.||||0.1272
91509297|NCT00457197|182890558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9642|TWO_SIDED||||||ANCOVA|||Baseline GGT used as covariate.||||0.9642
91509298|NCT00457197|182890559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7222|TWO_SIDED||||||ANCOVA|||Baseline AST used as covariate.||||0.7222
91509299|NCT00457197|182890560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1412|TWO_SIDED||||||ANCOVA|||Baseline ALT used as covariate.||||0.1412
91509300|NCT00457197|182890561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071|TWO_SIDED||||||ANCOVA|||Baseline HRSD used as covariate.||||0.7071
91509301|NCT00457197|182890562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2569|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.2569
91509302|NCT00457197|182890563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8814|TWO_SIDED||||||ANCOVA|||Baseline YMRS used as a covariate.||||0.8814
91509303|NCT00457197|182890564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473|TWO_SIDED||||||ANCOVA|||Baseline PACS used as a covariate.||||0.2473
91509304|NCT02114879|182890623|SUPERIORITY|||||||0.007||||||The p-value refers to the time by group interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Marginal Model|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.007
91509305|NCT02114879|182890624|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91509306|NCT02114879|182890625|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91509307|NCT02114879|182890626|SUPERIORITY|||||||0.96||||||The p-value refers to the time by group interaction. The statistical significance in this test was p\<0.05.|Mixed Models Analysis|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.96
91509308|NCT02114879|182890627|SUPERIORITY|||||||0.37||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Discharged Home Vs Discharged to Institution and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.37
91509309|NCT02114879|182890628|SUPERIORITY|||||||0.85||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Yes/No Rehospitalization and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.85
91509310|NCT03120013|182890638|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91509311|NCT03120013|182890639|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91509312|NCT03120013|182890640|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91509313|NCT03120013|182890641|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91509314|NCT03120013|182890642|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91509315|NCT03120013|182890643|SUPERIORITY||||||=|0.006|||||||ANCOVA|||||||=0.006
91509316|NCT03120013|182890644|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91509317|NCT03120013|182890645|SUPERIORITY||||||=|0.043|||||||ANCOVA|||||||=0.043
91759821|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97|||||TWO_SIDED|95.0|-3.9|-0.04||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-3.90|
91509318|NCT04847674|182890740|OTHER||LS mean difference|-0.027||||0.7914|TWO_SIDED|95.0|-0.2276|0.174|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1740|-0.2276|0.7914
91509319|NCT04847674|182890740|OTHER||LS mean difference|-0.011||||0.9115|TWO_SIDED|95.0|-0.2126|0.19|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1900|-0.2126|0.9115
91509320|NCT04847674|182890742|OTHER||LS mean difference|0.026||||0.6001|TWO_SIDED|95.0|-0.0733|0.1261|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1261|-0.0733|0.6001
91509321|NCT04847674|182890742|OTHER||LS mean difference|0.027||||0.5922|TWO_SIDED|95.0|-0.0732|0.1276|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1276|-0.0732|0.5922
91509322|NCT04847674|182890742|OTHER||LS mean difference|0.027||||0.6017|TWO_SIDED|95.0|-0.0744|0.1277|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1277|-0.0744|0.6017
91755538|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.18|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.51|1.18|
91755539|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.07|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.07|
91755540|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.79|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|0.79|
91755541|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.58|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.25|0.58|
91755542|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.94|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.93|0.94|
91755543|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.96|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.61|0.96|
91755544|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|1.09|
91755545|NCT00574548|183404205|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|1.86|4.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.35|1.86|
91755546|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.43|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.57|1.43|
91755547|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.95|3.16|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.16|1.95|
91755548|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.12|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.96|1.12|
91759822|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-4.35|-0.5||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.50|-4.35|
91509323|NCT04847674|182890742|OTHER||LS mean difference|0.022||||0.6664|TWO_SIDED|95.0|-0.0796|0.1239|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1239|-0.0796|0.6664
91755549|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.4|||||TWO_SIDED|95.0|1.67|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.31|1.67|
91755550|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.19|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.19|
91509324|NCT04847674|182890743|OTHER||Hodges-Lehmann (HL) estimator|0.4||||0.7261|TWO_SIDED|95.0|-2.33|3.31|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.31|-2.33|0.7261
91509325|NCT04847674|182890743|OTHER||HL estimator|-0.5||||0.765|TWO_SIDED|95.0|-3.56|3.32|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.32|-3.56|0.7650
91509326|NCT04847674|182890743|OTHER||HL estimator|0.2||||0.7942|TWO_SIDED|95.0|-2.44|3.04|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.04|-2.44|0.7942
91509327|NCT04847674|182890743|OTHER||HL estimator|-0.8||||0.6147|TWO_SIDED|95.0|-3.81|2.55|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||2.55|-3.81|0.6147
91509328|NCT04847674|182890745|OTHER||LS mean difference|-0.083||||0.4394|TWO_SIDED|95.0|-0.2971|0.1301|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1301|-0.2971|0.4394
91755551|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|4.3|||||TWO_SIDED|95.0|2.76|6.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||6.61|2.76|
91755552|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|3.3|||||TWO_SIDED|95.0|1.97|5.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||5.45|1.97|
91755553|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|0.98|2.1|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.10|0.98|
91755554|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.32|2.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.69|1.32|
91755555|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.27|2.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.07|1.27|
91755556|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.96|3.74|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.74|1.96|
91755557|NCT00574548|183404206|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.05|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.45|1.05|
91755558|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.54|
91755559|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.49|0.99|
91755560|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.68|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.68|0.43|
91509329|NCT04847674|182890745|OTHER||LS mean difference|-0.089||||0.4051|TWO_SIDED|95.0|-0.302|0.1231|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1231|-0.3020|0.4051
91509330|NCT04847674|182890748|OTHER||LS mean difference|0.093||||0.3485|TWO_SIDED|95.0|-0.1031|0.2893|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2893|-0.1031|0.3485
91509331|NCT04847674|182890748|OTHER||LS mean difference|0.033||||0.7432|TWO_SIDED|95.0|-0.1644|0.2296|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2296|-0.1644|0.7432
91509332|NCT04847674|182890748|OTHER||LS mean difference|0.087||||0.4014|TWO_SIDED|95.0|-0.118|0.292|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2920|-0.1180|0.4014
91509333|NCT04847674|182890748|OTHER||LS mean difference|0.01||||0.9259|TWO_SIDED|95.0|-0.196|0.2153|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2153|-0.1960|0.9259
91509334|NCT04847674|182890750|OTHER||LS mean difference|0.0||||0.9829|TWO_SIDED|95.0|-0.43|0.42|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.42|-0.43|0.9829
91509335|NCT04847674|182890750|OTHER||LS mean difference|0.1||||0.6302|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.52|-0.32|0.6302
91509336|NCT04847674|182890750|OTHER||LS mean difference|-0.1||||0.6707|TWO_SIDED|95.0|-0.54|0.35|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.35|-0.54|0.6707
91509337|NCT04847674|182890750|OTHER||LS mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.44|0.43|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.43|-0.44|0.9940
91509338|NCT04847674|182890751|OTHER||LS mean difference|-0.7||||0.4683|TWO_SIDED|95.0|-2.71|1.26|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.26|-2.71|0.4683
91533045|NCT04955626|182943218|OTHER||Geometric mean ratio (GMR)|1.22|||||TWO_SIDED|95.0|0.77|1.93||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.93|0.77|
91509339|NCT04847674|182890751|OTHER||LS mean difference|-1.2||||0.2239|TWO_SIDED|95.0|-3.16|0.75|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||0.75|-3.16|0.2239
91509340|NCT04847674|182890751|OTHER||LS mean difference|-0.6||||0.5389|TWO_SIDED|95.0|-2.51|1.32|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.32|-2.51|0.5389
91509341|NCT04847674|182890751|OTHER||LS mean difference|-0.9||||0.3564|TWO_SIDED|95.0|-2.75|1.0|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.00|-2.75|0.3564
91509342|NCT04847674|182890752|OTHER||LS mean difference|-0.2||||0.4436|TWO_SIDED|95.0|-0.62|0.27|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.27|-0.62|0.4436
91509343|NCT04847674|182890752|OTHER||LS mean difference|-0.1||||0.597|TWO_SIDED|95.0|-0.56|0.32|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.32|-0.56|0.5970
91509344|NCT04847674|182890752|OTHER||LS mean difference|-0.2||||0.3769|TWO_SIDED|95.0|-0.68|0.26|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.26|-0.68|0.3769
91509345|NCT04847674|182890752|OTHER||LS mean difference|-0.2||||0.4595|TWO_SIDED|95.0|-0.64|0.29|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.29|-0.64|0.4595
91509346|NCT01833403|182890775|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91509347|NCT02702401|182890777|SUPERIORITY||Hazard Ratio (HR)|0.775||||0.0186|TWO_SIDED|95.0|0.609|0.987|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.987|0.609|0.0186
91509348|NCT02702401|182890778|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0238|TWO_SIDED|95.0|0.611|0.998|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.998|0.611|0.0238
91509349|NCT02702401|182890779|OTHER||Difference in Percent|13.8|||||TWO_SIDED|95.0|7.7|19.5|||||Miettinen \& Nurminen method stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||19.5|7.7|
91759823|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.75|||||TWO_SIDED|95.0|-4.66|-0.83||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.83|-4.66|
91509350|NCT02702401|182890781|OTHER||Hazard Ratio (HR)|0.688||||0.0011|TWO_SIDED|95.0|0.54|0.877||One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Log Rank||Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.877|0.540|0.0011
91509351|NCT01686646|182890792|SUPERIORITY_OR_OTHER||LS Mean DIfference|3.5||||0.0248|TWO_SIDED|95.0|0.4|6.5||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||6.5|0.4|0.0248
91509352|NCT01686646|182890792|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1513|TWO_SIDED|95.0|-0.6|4.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||4.1|-0.6|0.1513
91509353|NCT01686646|182890792|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|||||TWO_SIDED|95.0|1.1|6.6||Not significant based on hierarchical testing.|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.||6.6|1.1|
91509354|NCT01686646|182890793|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0696|TWO_SIDED|95.0|-0.2|6.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.||6.1|-0.2|0.0696
91509355|NCT01686646|182890793|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|||||TWO_SIDED|95.0|0.3|5.2||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.2|0.3|
91509356|NCT01686646|182890793|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||||TWO_SIDED|95.0|-1.7|3.9||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||3.9|-1.7|
91509357|NCT00689481|182890811|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.016
91509358|NCT00689481|182890811|SUPERIORITY_OR_OTHER|||||||0.843|||||||Breslow-Day test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.843
91509359|NCT00689481|182890812|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.034
91509360|NCT00689481|182890813|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is significant based on the Holm stepwise closed testing procedure to control multiplicity for the key secondary analyses if primary analysis was significant.|Cochran-Mantel-Haenszel|Stratified by pooled center.||||||0.004
91509361|NCT00689481|182890814|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.052
91509362|NCT00689481|182890815|SUPERIORITY_OR_OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.033
91509363|NCT00689481|182890816|SUPERIORITY_OR_OTHER|||||||0.859|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.859
91509364|NCT00689481|182890816|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.015
91533046|NCT04955626|182943218|OTHER||Geometric mean ratio (GMR)|1.13|||||TWO_SIDED|95.0|0.71|1.8||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.80|0.71|
91755561|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.77|0.43|
91755562|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.08|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.08|0.67|
91755563|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.12|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.12|0.71|
91755564|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.24|0.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.49|0.24|
91755565|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.26|0.51|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.51|0.26|
91755566|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.02|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.02|0.60|
91755567|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.87|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.87|0.54|
91755568|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.53|
91755569|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
91509365|NCT03337724|182890817|SUPERIORITY||Stratified Hazard Ratio|1.02||||0.9237|TWO_SIDED|95.0|0.71|1.45|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.45|0.71|0.9237
91509366|NCT03337724|182890818|SUPERIORITY||Stratified Hazard Ratio|1.0||||0.9965|TWO_SIDED|95.0|0.71|1.4|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.40|0.71|0.9965
91509367|NCT03337724|182890826|SUPERIORITY||Stratified Hazard Ratio|1.08|||||TWO_SIDED|95.0|0.73|1.58|||||Stratification was done prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.58|0.73|
91509368|NCT03337724|182890826|SUPERIORITY||Stratified Hazard Ratio|0.94|||||TWO_SIDED|95.0|0.65|1.37|||||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.37|0.65|
91509369|NCT03337724|182890829|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.2162|TWO_SIDED|95.0|0.83|2.22|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).||Stratified Analysis|2.22|0.83|0.2162
91755570|NCT00574548|183404207|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.15|2.13|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.13|1.15|
91755571|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.55|0.75|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.75|0.55|
91755572|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.52|2.01|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.01|1.52|
91755573|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.66|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.66|0.49|
91755574|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.03|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.03|0.67|
91509370|NCT02026115|182890856|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
91509371|NCT02026115|182890857|SUPERIORITY|||||||0.02||||||Experimental group performed worse than usual care.|Mixed Models Analysis|||||||.02
91509372|NCT02026115|182890858|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
91755575|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.79|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.79|0.57|
91755576|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.52|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.52|0.35|
91509373|NCT02026115|182890859|SUPERIORITY|||||||0.36|||||||Regression, Logistic|||||||.36
91509374|NCT02026115|182890860|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||.01
91509375|NCT02026115|182890861|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91509376|NCT04976530|182890889|SUPERIORITY||win ratio|1.07||||0.748|TWO_SIDED|95.0|0.72|1.58|||Finkelstein Schoenfeld test|||||1.58|0.72|0.748
91509377|NCT04976530|182890890|SUPERIORITY||win ratio|1.33||||0.202|TWO_SIDED|95.0|0.86|2.04|||Finkelstein Schoenfeld test|||||2.04|0.86|0.202
91509378|NCT04976530|182890891|SUPERIORITY||win ratio|1.17||||0.451|TWO_SIDED|95.0|0.79|1.73|||Finkelstein Schoenfeld test|||||1.73|0.79|0.451
91509379|NCT04976530|182890892|SUPERIORITY||win ratio|1.59||||0.041|TWO_SIDED|95.0|1.02|2.46|||Finkelstein Schoenfeld test|||||2.46|1.02|0.041
91509380|NCT04976530|182890893|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
91509381|NCT04976530|182890894|SUPERIORITY|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||||||0.079
91509382|NCT04976530|182890895|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
91509383|NCT04976530|182890896|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
91509384|NCT04084769|182890911|OTHER|95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Difference in percentage|1.65|||||TWO_SIDED|95.0|-3.58|6.95||||||Serogroup A||6.95|-3.58|
91509385|NCT04084769|182890911|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.74|||||TWO_SIDED|95.0|-5.5|1.6||||||Serogroup C||1.60|-5.50|
91755577|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.69|0.41|
91755578|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.75|
91755579|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.85|0.58|
91755580|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.74|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.74|0.58|
91755581|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.39|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.39|0.89|
91755582|NCT00574548|183404208|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.73|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.73|0.50|
91755583|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.03|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.03|
91755584|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.18|1.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.89|1.18|
91755585|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.07|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.07|
91755586|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.77|3.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.61|1.77|
91755587|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.94|3.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.88|1.94|
91755588|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|8.5|||||TWO_SIDED|95.0|5.68|12.6|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||12.60|5.68|
91755589|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|6.7|||||TWO_SIDED|95.0|4.45|10.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||10.22|4.45|
91755590|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.02|2.18|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.18|1.02|
91509386|NCT04084769|182890911|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.15|||||TWO_SIDED|95.0|-4.09|1.14||||||Serogroup Y||1.14|-4.09|
91509387|NCT04084769|182890911|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.16|||||TWO_SIDED|95.0|-4.72|2.07||||||Serogroup W||2.07|-4.72|
91509388|NCT04477304|182890928|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.12|-0.07||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.07|-0.12|<0.001
91509389|NCT04477304|182890929|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.23|-0.16||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.16|-0.23|<0.001
91509390|NCT04477304|182890930|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.06|-0.10|<0.001
91509391|NCT04477304|182890931|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.08|-0.03||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.03|-0.08|<0.001
91509392|NCT04477304|182890932|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.392|TWO_SIDED|95.0|-0.03|-0.01||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.01|-0.03|0.392
91509393|NCT04477304|182890933|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.13|-0.05||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.05|-0.13|<0.001
91509394|NCT02782949|182890940|SUPERIORITY|||||||0.399|||||||Wilcoxon Rank-Sum test|||||||0.3990
91755591|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|2.01|3.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.89|2.01|
91755592|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.92|3.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.13|1.92|
91755593|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.8|3.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.44|1.80|
91509395|NCT02782949|182890943|SUPERIORITY|||||||0.74|||||||Fisher Exact|||||||0.74
91509396|NCT03238911|182890949|SUPERIORITY||Risk Difference (RD)|-67.0|||<|0.0001|TWO_SIDED|95.0|-77.4|-51.5|||Cochran-Mantel-Haenszel||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-51.5|-77.4|<0.0001
91509397|NCT03238911|182890950|SUPERIORITY|||||||0.8979|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.8979
91509398|NCT03238911|182890951|SUPERIORITY||Risk Difference (RD)|-39.2|||<|0.0001|TWO_SIDED|95.0|-52.2|-23.3|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-23.3|-52.2|<0.0001
91533047|NCT04955626|182943218|OTHER||Geometric mean ratio (GMR)|1.16|||||TWO_SIDED|95.0|0.73|1.84||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.84|0.73|
91509399|NCT03238911|182890952|SUPERIORITY||Mean Difference (Final Values)|0.48|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.65|0.31|<0.0001
91509400|NCT03238911|182890952|SUPERIORITY||Mean Difference (Final Values)|1.06|||<|0.0001|TWO_SIDED|95.0|0.85|1.27|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.27|0.85|<0.0001
91509401|NCT03238911|182890952|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.81|1.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.25|0.81|<0.0001
91509402|NCT03238911|182890952|SUPERIORITY||Mean Difference (Final Values)|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.60|1.10|<0.0001
91509403|NCT03238911|182890952|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.75|1.32|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.32|0.75|<0.0001
91509404|NCT03238911|182890952|SUPERIORITY||Mean Difference (Final Values)|1.13|||<|0.0001|TWO_SIDED|95.0|0.86|1.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.39|0.86|<0.0001
91755594|NCT00574548|183404209|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.9|||||TWO_SIDED|95.0|1.92|4.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.28|1.92|
91533048|NCT04955626|182943218|OTHER||Geometric mean ratio (GMR)|1.49|||||TWO_SIDED|95.0|0.94|2.37||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.37|0.94|
91755595|NCT01209078|183404285|SUPERIORITY_OR_OTHER||Difference|-22.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.||||
91755596|NCT01209078|183404285|SUPERIORITY_OR_OTHER||Difference|-24.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.||||
91755597|NCT01209078|183404286|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
91755598|NCT01209078|183404287|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
91755599|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.41|0.74|||Mixed Models Analysis|||GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.||0.74|-0.41|
91755600|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.7|0.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.||0.45|-0.70|
91755601|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.74|0.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.||0.43|-0.74|
91755602|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.25|0.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.||0.95|-0.25|
91509405|NCT03238911|182890953|SUPERIORITY||Mean Difference (Final Values)|15.55|||<|0.0001|TWO_SIDED|95.0|10.32|20.79|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||20.79|10.32|<0.0001
91509406|NCT03238911|182890953|SUPERIORITY||Mean Difference (Final Values)|33.23|||<|0.0001|TWO_SIDED|95.0|26.62|39.84|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|26.62|<0.0001
91509407|NCT03238911|182890953|SUPERIORITY||Mean Difference (Final Values)|32.78|||<|0.0001|TWO_SIDED|95.0|25.71|39.84|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|25.71|<0.0001
91509408|NCT03238911|182890953|SUPERIORITY||Mean Difference (Final Values)|42.11|||<|0.0001|TWO_SIDED|95.0|33.89|50.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||50.32|33.89|<0.0001
91755603|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.49|0.72|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.||0.72|-0.49|
91755604|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.53|0.66|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.||0.66|-0.53|
91755605|NCT01209078|183404290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.65|0.58|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.||0.58|-0.65|
91755606|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
91755607|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
91755608|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
91755609|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
91509409|NCT03238911|182890953|SUPERIORITY||Mean Difference (Final Values)|32.28|||<|0.0001|TWO_SIDED|95.0|23.09|41.48|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.48|23.09|<0.0001
91509410|NCT03238911|182890953|SUPERIORITY||Mean Difference (Final Values)|36.06|||<|0.0001|TWO_SIDED|95.0|27.33|44.78|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||44.78|27.33|<0.0001
91533049|NCT04955626|182943219|OTHER||Geometric mean ratio (GMR)|0.49|||||TWO_SIDED|95.0|0.24|1.03||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.03|0.24|
91755610|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
91755611|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
91755612|NCT01209078|183404291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
91755613|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
91755614|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
91755615|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
91755616|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
91755617|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
91755618|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
91755619|NCT01209078|183404292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
91755620|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.85|||||TWO_SIDED|95.0|-132.8|-4.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.||-4.95|-132.8|
91755621|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06|||||TWO_SIDED|95.0|-66.54|60.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.||60.43|-66.54|
91755622|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Median Difference (Net)|31.47|||||TWO_SIDED|95.0|-33.53|96.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.||96.47|-33.53|
91755623|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.94|||||TWO_SIDED|95.0|-22.43|110.31|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.||110.31|-22.43|
91755624|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.21|||||TWO_SIDED|95.0|-33.03|101.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.||101.45|-33.03|
91755625|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.57|||||TWO_SIDED|95.0|-28.25|103.4|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.||103.40|-28.25|
91755626|NCT01209078|183404293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.4|||||TWO_SIDED|95.0|-30.77|105.56|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.||105.56|-30.77|
91509411|NCT03238911|182890955|SUPERIORITY||Mean Difference (Final Values)|-105.74|||<|0.0001|TWO_SIDED|95.0|-131.04|-80.45|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-80.45|-131.04|<0.0001
91509412|NCT03238911|182890955|SUPERIORITY||Mean Difference (Final Values)|-60.76|||<|0.0001|TWO_SIDED|95.0|-82.95|-38.58|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-38.58|-82.95|<0.0001
91509413|NCT03238911|182890955|SUPERIORITY||Mean Difference (Final Values)|-293.23|||<|0.0001|TWO_SIDED|95.0|-368.15|-218.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-218.30|-368.15|<0.0001
91509414|NCT03238911|182890955|SUPERIORITY||Mean Difference (Final Values)|-117.47|||<|0.0001|TWO_SIDED|95.0|-151.6|-83.33|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-83.33|-151.60|<0.0001
91509415|NCT03238911|182890955|SUPERIORITY||Mean Difference (Final Values)|-71.21|||<|0.0001|TWO_SIDED|95.0|-101.8|-40.61|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.61|-101.80|<0.0001
91509416|NCT03238911|182890955|SUPERIORITY||Mean Difference (Final Values)|-37.16|||<|0.0001|TWO_SIDED|95.0|-54.92|-19.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-19.39|-54.92|<0.0001
91509417|NCT03238911|182890956|SUPERIORITY||Mean Difference (Final Values)|-99.1|||<|0.0001|TWO_SIDED|95.0|-136.42|-61.76|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-61.76|-136.42|<0.0001
91755627|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|-35.4|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).||||
91509418|NCT03238911|182890956|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.0001|TWO_SIDED|95.0|-72.8|-25.9|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-25.90|-72.80|<0.0001
91509419|NCT03238911|182890956|SUPERIORITY||Mean Difference (Final Values)|-191.3|||<|0.0001|TWO_SIDED|95.0|-242.47|-140.09|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-140.09|-242.47|<0.0001
91533050|NCT04955626|182943219|OTHER||Geometric mean ratio (GMR)|1.84|||||TWO_SIDED|95.0|0.9|3.76||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.76|0.90|
91533051|NCT04955626|182943219|OTHER||Geometric mean ratio (GMR)|1.72|||||TWO_SIDED|95.0|0.84|3.5||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.50|0.84|
91533052|NCT04955626|182943219|OTHER||Geometric mean ratio (GMR)|1.75|||||TWO_SIDED|95.0|0.85|3.59||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.59|0.85|
91755628|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.||||
91755629|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|-28.6|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.||||
91755630|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|-66.7|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.||||
91533053|NCT04955626|182943219|OTHER||Geometric mean ratio (GMR)|1.56|||||TWO_SIDED|95.0|0.76|3.2||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.20|0.76|
91533054|NCT04955626|182943220|OTHER||Geometric mean ratio (GMR)|0.5|||||TWO_SIDED|95.0|0.26|0.95||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||0.95|0.26|
91755631|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|-25.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.||||
91755632|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.||||
91755633|NCT01209078|183404294|SUPERIORITY_OR_OTHER||Difference|2.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.||||
91755634|NCT00448747|183404301|OTHER||ROC AUC|0.923|||||ONE_SIDED|99.0|0.85|||||||Summary of ROC Analyses following macimorelin administration.|||0.850|
91755635|NCT00448747|183404301|OTHER|Sensitivity|sensitivity (percent)|82.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
91755636|NCT00448747|183404301|OTHER|Specificity|Specificity (percent)|92.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
91755637|NCT00448747|183404301|OTHER|Misclassification|misclassification (percent)|13.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
91755638|NCT00448747|183404302|OTHER||Mean Difference (Final Values)|-5.1|STANDARD_DEVIATION|9.57|||TWO_SIDED|||||||||Summary of IGF-1 before and after AEZS-130 administration: post - pre differences||||
91755639|NCT00448747|183404302|OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|16.25|||TWO_SIDED|||||||||||||
91509420|NCT03238911|182890956|SUPERIORITY||Mean Difference (Final Values)|-100.7|||<|0.0001|TWO_SIDED|95.0|-137.19|-64.2|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-64.20|-137.19|<0.0001
91509421|NCT03238911|182890956|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.0001|TWO_SIDED|95.0|-71.78|-24.96|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-24.96|-71.78|<0.0001
91509422|NCT03238911|182890956|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.1411|TWO_SIDED|95.0|-35.04|5.06|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.06|-35.04|0.1411
91509423|NCT03238911|182890957|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.562|TWO_SIDED|95.0|-1.08|0.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.59|-1.08|0.5620
91509424|NCT03238911|182890957|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0126|TWO_SIDED|95.0|0.38|3.12|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|0.38|0.0126
91755640|NCT00568126|183404308|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|2.1||||0.55|TWO_SIDED|95.0|0.18|25.2||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||25.2|0.18|0.55
91755641|NCT00568126|183404309|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|1.71||||0.47|TWO_SIDED|95.0|0.4|7.34||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||7.34|0.40|0.47
91755642|NCT02429791|183404315|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.3|3.0|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI).|||3.0|-4.3|
91755643|NCT02429791|183404317|OTHER||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-1.9|4.0|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||4.0|-1.9|
91509425|NCT03238911|182890957|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.608|TWO_SIDED|95.0|-1.19|2.02|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.02|-1.19|0.6080
91509426|NCT03238911|182890957|SUPERIORITY||Mean Difference (Final Values)|2.09||||0.0379|TWO_SIDED|95.0|0.12|4.05|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.05|0.12|0.0379
91509427|NCT03238911|182890957|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.2368|TWO_SIDED|95.0|-0.78|3.12|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|-0.78|0.2368
91509428|NCT03238911|182890957|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.8287|TWO_SIDED|95.0|-2.18|1.75|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.75|-2.18|0.8287
91509429|NCT03238911|182890958|SUPERIORITY||Mean Difference (Final Values)|24.27|||<|0.0001|TWO_SIDED|95.0|18.81|29.73|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.73|18.81|<0.0001
91755644|NCT02429791|183404328|OTHER|||||||0.007||||||P-value for interaction between treatment group and baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
91509430|NCT03238911|182890958|SUPERIORITY||Mean Difference (Final Values)|15.75|||<|0.0001|TWO_SIDED|95.0|8.83|22.67|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.67|8.83|<0.0001
91509431|NCT03238911|182890958|SUPERIORITY||Mean Difference (Final Values)|20.14|||<|0.0001|TWO_SIDED|95.0|12.07|28.22|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.22|12.07|<0.0001
91533055|NCT04955626|182943220|OTHER||Geometric mean ratio (GMR)|0.76|||||TWO_SIDED|95.0|0.41|1.43||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.43|0.41|
91755645|NCT02429791|183404328|SUPERIORITY||Odds Ratio (OR)|0.958||||0.275|TWO_SIDED|95.0|0.888|1.034||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.034|0.888|0.275
91755646|NCT02429791|183404328|SUPERIORITY||Odds Ratio (OR)|0.902||||0.112|TWO_SIDED|95.0|0.793|1.025||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.025|0.793|0.112
91755647|NCT02429791|183404328|SUPERIORITY||Odds Ratio (OR)|0.847||||0.002|TWO_SIDED|95.0|0.763|0.942||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||0.942|0.763|0.002
91755648|NCT02429791|183404330|OTHER|||||||0.001||||||P-value for interaction between treatment group and baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
91755649|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.724|||<|0.001|TWO_SIDED|95.0|0.679|0.772||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.772|0.679|<.001
91755650|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.825|||<|0.001|TWO_SIDED|95.0|0.742|0.918||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.918|0.742|<.001
91509432|NCT03238911|182890958|SUPERIORITY||Mean Difference (Final Values)|32.22|||<|0.0001|TWO_SIDED|95.0|25.49|38.96|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||38.96|25.49|<0.0001
91509433|NCT03238911|182890958|SUPERIORITY||Mean Difference (Final Values)|22.87|||<|0.0001|TWO_SIDED|95.0|14.79|30.95|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||30.95|14.79|<0.0001
91509434|NCT03238911|182890958|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.0043|TWO_SIDED|95.0|3.39|17.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||17.82|3.39|0.0043
91509435|NCT03238911|182890959|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.0552|TWO_SIDED|95.0|-0.34|0.0|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.00|-0.34|0.0552
91509436|NCT03238911|182890959|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0023|TWO_SIDED|95.0|-0.6|-0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.13|-0.60|0.0023
91509437|NCT03238911|182890959|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.0008|TWO_SIDED|95.0|-0.8|-0.21|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.21|-0.80|0.0008
91509438|NCT03238911|182890959|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.49|-1.11|<0.0001
91509439|NCT03238911|182890959|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.01|-0.28|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.28|-1.01|0.0006
91509440|NCT03238911|182890959|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.94|-0.23|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.23|-0.94|0.0014
91509441|NCT03238911|182890960|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.7447|TWO_SIDED|95.0|-7.96|5.71|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.71|-7.96|0.7447
91509442|NCT03238911|182890960|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.0363|TWO_SIDED|95.0|-18.78|-0.63|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.63|-18.78|0.0363
91509443|NCT03238911|182890960|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.9242|TWO_SIDED|95.0|-10.56|9.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.59|-10.56|0.9242
91509444|NCT03238911|182890960|SUPERIORITY||Mean Difference (Final Values)|-11.17||||0.0602|TWO_SIDED|95.0|-22.84|0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.49|-22.84|0.0602
91509445|NCT03238911|182890960|SUPERIORITY||Mean Difference (Final Values)|-18.2||||0.0008|TWO_SIDED|95.0|-28.68|-7.73|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-7.73|-28.68|0.0008
91509446|NCT03238911|182890960|SUPERIORITY||Mean Difference (Final Values)|-19.79||||0.0031|TWO_SIDED|95.0|-32.75|-6.83|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-6.83|-32.75|0.0031
91509447|NCT03238911|182890961|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.267|TWO_SIDED|95.0|-0.029|0.104|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.104|-0.029|0.2670
91509448|NCT03238911|182890961|SUPERIORITY||Mean Difference (Final Values)|0.085||||0.004|TWO_SIDED|95.0|0.028|0.142|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.142|0.028|0.0040
91509449|NCT03238911|182890961|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.0472|TWO_SIDED|95.0|0.001|0.127|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.127|0.001|0.0472
91509450|NCT03238911|182890961|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.005|TWO_SIDED|95.0|0.031|0.171|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.171|0.031|0.0050
91533056|NCT04955626|182943220|OTHER||Geometric mean ratio (GMR)|0.98|||||TWO_SIDED|95.0|0.52|1.84||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.84|0.52|
91755651|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.81|||<|0.001|TWO_SIDED|95.0|0.742|0.884||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.884|0.742|<.001
91509451|NCT03238911|182890961|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.0061|TWO_SIDED|95.0|0.029|0.172|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.172|0.029|0.0061
91509452|NCT03238911|182890961|SUPERIORITY||Mean Difference (Final Values)|0.055||||0.1282|TWO_SIDED|95.0|-0.016|0.126|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.126|-0.016|0.1282
91533057|NCT04955626|182943220|OTHER||Geometric mean ratio (GMR)|0.96|||||TWO_SIDED|95.0|0.51|1.8||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.80|0.51|
91755652|NCT02429791|183404330|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
91755653|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.817|||<|0.001|TWO_SIDED|95.0|0.774|0.863||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.863|0.774|<.001
91755654|NCT02429791|183404330|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
91509453|NCT03238911|182890963|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.4618|TWO_SIDED|95.0|-0.82|0.37|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.37|-0.82|0.4618
91509454|NCT03238911|182890963|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.366|TWO_SIDED|95.0|-0.54|0.2|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.20|-0.54|0.3660
91509455|NCT03238911|182890963|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.25|0.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.30|-0.25|0.8580
91509456|NCT03238911|182890963|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.0257|TWO_SIDED|95.0|0.05|0.74|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.74|0.05|0.0257
91509457|NCT03238911|182890963|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.0016|TWO_SIDED|95.0|0.19|0.77|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.77|0.19|0.0016
91509458|NCT03238911|182890963|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.0185|TWO_SIDED|95.0|0.07|0.76|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.07|0.0185
91533058|NCT04955626|182943220|OTHER||Geometric mean ratio (GMR)|0.71|||||TWO_SIDED|95.0|0.38|1.34||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.34|0.38|
91533059|NCT04955626|182943221|OTHER||Geometric mean ratio (GMR)|0.72|||||TWO_SIDED|95.0|0.38|1.37||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.37|0.38|
91533060|NCT04955626|182943221|OTHER||Geometric mean ratio (GMR)|1.19|||||TWO_SIDED|95.0|0.65|2.21||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.21|0.65|
91533061|NCT04955626|182943221|OTHER||Geometric mean ratio (GMR)|1.63|||||TWO_SIDED|95.0|0.88|3.02||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.02|0.88|
91533062|NCT04955626|182943221|OTHER||Geometric mean ratio (GMR)|1.28|||||TWO_SIDED|95.0|0.68|2.39||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.39|0.68|
91533063|NCT04955626|182943221|OTHER||Geometric mean ratio (GMR)|1.42|||||TWO_SIDED|95.0|0.76|2.67||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.67|0.76|
91755655|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.881|||<|0.001|TWO_SIDED|95.0|0.823|0.943||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.943|0.823|<.001
91755656|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.829||||0.001|TWO_SIDED|95.0|0.74|0.93||P value to assess difference between treatment groups (osteocalcin - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.930|0.740|0.001
91755657|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.691|||<|0.001|TWO_SIDED|95.0|0.628|0.759||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.759|0.628|<.001
91755658|NCT02429791|183404330|OTHER|||||||0.782||||||P-value for interaction between treatment group and baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
91755659|NCT02429791|183404330|SUPERIORITY||Odds Ratio (OR)|0.804|||<|0.001|TWO_SIDED|95.0|0.742|0.872||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.872|0.742|<.001
91509459|NCT03238911|182890964|SUPERIORITY||Mean Difference (Final Values)|-14.84||||0.1922|TWO_SIDED|95.0|-37.26|7.57|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||7.57|-37.26|0.1922
91509460|NCT03238911|182890964|SUPERIORITY||Mean Difference (Final Values)|-18.28||||0.5601|TWO_SIDED|95.0|-80.24|43.68|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.68|-80.24|0.5601
91509461|NCT03238911|182890964|SUPERIORITY||Mean Difference (Final Values)|-71.02||||0.0459|TWO_SIDED|95.0|-140.74|-1.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.30|-140.74|0.0459
91509462|NCT03238911|182890964|SUPERIORITY||Mean Difference (Final Values)|-207.33|||<|0.0001|TWO_SIDED|95.0|-268.82|-145.84|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-145.84|-268.82|<0.0001
91509463|NCT03238911|182890964|SUPERIORITY||Mean Difference (Final Values)|-78.6||||0.001|TWO_SIDED|95.0|-124.81|-32.39|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.39|-124.81|0.0010
91509464|NCT03238911|182890964|SUPERIORITY||Mean Difference (Final Values)|-58.79||||0.0002|TWO_SIDED|95.0|-88.75|-28.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-28.82|-88.75|0.0002
91509465|NCT03238911|182890965|SUPERIORITY||Mean Difference (Final Values)|40.82|||<|0.0001|TWO_SIDED|95.0|26.3|55.33|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||55.33|26.30|<0.0001
91509466|NCT03238911|182890965|SUPERIORITY||Mean Difference (Final Values)|6.61||||0.0089|TWO_SIDED|95.0|1.69|11.53|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.53|1.69|0.0089
91755660|NCT02429791|183404343|OTHER|||||||0.317||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.317
91533064|NCT04955626|182943222|OTHER||Geometric mean ratio (GMR)|0.52|||||TWO_SIDED|95.0|0.21|1.25||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.25|0.21|
91755661|NCT02429791|183404343|OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.7|1.5|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.5|-7.7|
91755662|NCT02429791|183404343|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-5.1|9.0|||||INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||9.0|-5.1|
91755663|NCT02429791|183404343|OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-5.3|10.8|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||10.8|-5.3|
91755664|NCT02429791|183404351|OTHER|||||||0.94||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.940
91755665|NCT02429791|183404351|SUPERIORITY||Mean Difference (Final Values)|-2.924|||<|0.001|TWO_SIDED|95.0|-4.26|-1.588||P value to assess difference between treatment groups (Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-1.588|-4.260|<.001
91755666|NCT02429791|183404351|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.001
91509467|NCT03238911|182890965|SUPERIORITY||Mean Difference (Final Values)|-43.48|||<|0.0001|TWO_SIDED|95.0|-54.92|-32.03|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.03|-54.92|<0.0001
91509468|NCT03238911|182890965|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.373|TWO_SIDED|95.0|-5.41|2.04|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-5.41|0.3730
91509469|NCT03238911|182890965|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.4778|TWO_SIDED|95.0|-6.15|2.9|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.90|-6.15|0.4778
91509470|NCT03238911|182890965|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.3575|TWO_SIDED|95.0|-5.44|1.98|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.98|-5.44|0.3575
91509471|NCT03238911|182890966|SUPERIORITY||Risk Difference (RD)|-11.9||||0.005|TWO_SIDED|95.0|-20.1|-3.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-3.6|-20.1|0.0050
91509472|NCT06893809|182890967|SUPERIORITY||Median Difference (Net)|10.0|STANDARD_DEVIATION|5.0||0.05|TWO_SIDED|95.0|10.0|20.0|||Kruskal-Wallis|||Sixty male patients scheduled for TURP surgery were divided into three equal groups. The results were evaluated at a 95% confidence interval, with significance set at p \< 0.05. This was achieved using SPSS 15.0. Between-group comparisons were performed using One-way ANOVA, Kruskal-Wallis, Wilcoxon Signed Ranks, and Friedman tests. Within-group comparisons used Wilcoxon Signed Ranks tests, and Friedman tests were used for differences over time.||20|10|0.05
91509473|NCT06893809|182890967|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0|>|0.05|TWO_SIDED|95.0|0.0|0.0||No adjustment for multiple comparisons was applied. Non-parametric method used due to ordinal scale structure.|Kruskal-Wallis||Patient and surgeon satisfaction were compared across study arms.|The aim of this analysis is to compare the three groups in terms of patient and surgeon satisfaction using a superiority approach. The null hypothesis is that there is no difference in satisfaction scores between the groups. Statistical significance was set at p \< 0.05.||0|0|>0.05
91509474|NCT06893809|182890969|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.05|TWO_SIDED|95.0|0.5|1.6|||Kruskal-Wallis|Non-parametric test used due to ordinal scale and non-normal distribution.|Sensory block levels compared across study arms using numerical dermatomal codes.|||1.6|0.5|0.05
91533065|NCT04955626|182943222|OTHER||Geometric mean ratio (GMR)|2.07|||||TWO_SIDED|95.0|0.88|4.88||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||4.88|0.88|
91509475|NCT06893809|182890971|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|95.0|0.07|0.93|||Kruskal-Wallis||Dermatomal regression levels were compared across groups at 60 minutes.|||0.93|0.07|<0.05
91509476|NCT03091192|182890972|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.313|TWO_SIDED|95.0|0.37|1.36|||Log Rank|||||1.36|0.37|0.313
91509477|NCT03091192|182890973|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.11|TWO_SIDED|95.0|0.21|1.17|||Log Rank||A hazard ratio \< 1 favours Savolitinib|||1.17|0.21|0.110
91509478|NCT00368940|182891013|SUPERIORITY||Cohen D at week 12|0.6||||0.005|TWO_SIDED|95.0|0.13|1.06|||Mixed Models Analysis|||||1.06|0.13|0.005
91509479|NCT00368940|182891014|SUPERIORITY||Cohen D at week 12|0.67||||0.001|TWO_SIDED|95.0|0.2|1.14|||Mixed Models Analysis|||||1.14|0.20|0.001
91509480|NCT00368940|182891015|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||||||0.0268
91509481|NCT00368940|182891016|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91509482|NCT03370341|182891022|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.56
91509483|NCT03370341|182891023|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.38
91509484|NCT02573324|182891041|SUPERIORITY||Cox Proportional Hazard|1.02||||0.633|TWO_SIDED|95.0|0.82|1.26||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|Terms abbreviated below: O6-methylguaninemethlytransferese (MGMT); Recursive Partitioning Analysis (RPA); EGFRde2-7 (EGFRvIII)||1.26|0.82|0.633
91755667|NCT02429791|183404351|SUPERIORITY||Mean Difference (Final Values)|-1.192||||0.11|TWO_SIDED|95.0|-2.656|0.271||P value to assess difference between treatment groups (Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.271|-2.656|0.110
91509485|NCT02573324|182891041|SUPERIORITY|||||||0.704||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.704
91509486|NCT02573324|182891042|SUPERIORITY||Cox Proportional Hazard|0.97||||0.504|TWO_SIDED|95.0|0.76|1.24||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.24|0.76|0.504
91509487|NCT02573324|182891042|SUPERIORITY|||||||0.599||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.599
91509488|NCT02573324|182891043|SUPERIORITY||Cox Proportional Hazard|1.17||||0.773|TWO_SIDED|95.0|0.76|1.8||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.80|0.76|0.773
91509489|NCT02573324|182891043|SUPERIORITY|||||||0.74||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.740
91509490|NCT02573324|182891044|SUPERIORITY||Cox Proportional Hazard|0.95||||0.381|TWO_SIDED|95.0|0.71|1.27||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.27|0.71|0.381
91509491|NCT02573324|182891044|SUPERIORITY|||||||0.409||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.409
91509492|NCT02573324|182891045|SUPERIORITY||Cox Proportional Hazard|0.84||||0.029|TWO_SIDED|95.0|0.7|1.01||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.01|0.70|0.029
91509493|NCT02573324|182891046|SUPERIORITY||Cox Proportional Hazard|0.72||||0.002|TWO_SIDED|95.0|0.56|0.93||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||0.93|0.56|0.002
91509494|NCT02573324|182891047|SUPERIORITY||Cox Proportional Hazard|1.329||||0.994|TWO_SIDED|95.0|1.087|1.626||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.626|1.087|0.994
91533066|NCT04955626|182943222|OTHER||Geometric mean ratio (GMR)|2.96|||||TWO_SIDED|95.0|1.24|7.06||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||7.06|1.24|
91533067|NCT04955626|182943222|OTHER||Geometric mean ratio (GMR)|1.52|||||TWO_SIDED|95.0|0.64|3.62||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.62|0.64|
91509495|NCT02573324|182891048|SUPERIORITY||Cox Proportional Hazard|1.185||||0.938|TWO_SIDED|95.0|0.972|1.446||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.446|0.972|0.938
91509496|NCT02573324|182891049|SUPERIORITY||Cox Proportional Hazard|1.136||||0.814|TWO_SIDED|95.0|0.921|1.402||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.402|0.921|0.814
91509497|NCT03892889|182891066|OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used based on the prospective phase efficacy sample when applicable.|paired t-test|||||||<0.0001
91509498|NCT02873923|182891073|OTHER||Correlation coefficient|0.66|||||TWO_SIDED|95.0|0.63|0.68|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.68|0.63|
91533068|NCT04955626|182943222|OTHER||Geometric mean ratio|1.53|||||TWO_SIDED|95.0|0.64|3.67||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.67|0.64|
91509499|NCT02873923|182891074|OTHER||correlation coefficient|0.0|||||TWO_SIDED|95.0|0.0|0.005|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.005|0.00|
91509500|NCT01639001|182891078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.402|||<|0.0001|TWO_SIDED|95.0|0.286|0.565||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ECOG PS, ethnicity, and brain metastases) was significant at the 0.02496level.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|The study was designed to test the null hypothesis H0: λ=1.0 versus the alternative hypothesis HA: λ \< 1.0, where λ is the hazard ratio (HR; Crizotinib/Chemotherapy). Evaluation of 160 PFS events in the 2 arms using a 1-sided log-rank test at the 0.025 level of significance was required to detect a HR of 0.64 with 80% power.||0.565|0.286|<0.0001
91509501|NCT01639001|182891079|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.869|||<|0.0001|TWO_SIDED|95.0|30.34|53.398||If the PFS endpoint was significant, ORR was to be considered significant if 2-sided p-value from Pearson chi-square test was \<= 0.04992.|2-sided pearson chi-square test||Treatment difference in ORR (%)|The confidence interval for the treatment difference was based on normal distribution.||53.398|30.340|<0.0001
91509502|NCT01639001|182891080|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.056||||0.6172|TWO_SIDED|95.0|0.734|1.521||If the PFS and ORR endpoints were significant, OS was to be considered significant if 1-sided, log-rank test stratified for ECOG, ethnicity and metastases was \<= 0.02496.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|||1.521|0.734|0.6172
91509503|NCT01639001|182891081|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|8.906||||0.1204|TWO_SIDED|95.0|-2.275|20.086|||2-sided pearson chi-square test||Treatment Difference in DCR Rate (%)|The confidence interval for the treatment difference was based on normal distribution.||20.086|-2.275|0.1204
91509504|NCT01639001|182891085|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348|||<|0.0001|TWO_SIDED|95.0|0.246|0.493|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.493|0.246|<0.0001
91509505|NCT01639001|182891086|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.669||||0.127|TWO_SIDED|95.0|0.335|1.338|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||1.338|0.335|0.1270
91533069|NCT04955626|182943223|OTHER||Geometric mean ratio (GMR)|0.52|||||TWO_SIDED|95.0|0.25|1.09||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.09|0.25|
91533070|NCT04955626|182943223|OTHER||Geometric mean ratio (GMR)|1.0|||||TWO_SIDED|95.0|0.49|2.04||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.04|0.49|
91533071|NCT04955626|182943223|OTHER||Geometric mean ratio (GMR)|1.29|||||TWO_SIDED|95.0|0.63|2.68||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.68|0.63|
91509506|NCT01639001|182891087|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.277|||<|0.0001|TWO_SIDED|95.0|0.186|0.412|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.412|0.186|<0.0001
91509507|NCT01639001|182891088|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.432|||<|0.0001|TWO_SIDED|95.0|0.307|0.61||2-sided Hochberg adjusted p-values|2 sided unstratified log rank||Based on the Cox Proportional hazards model.|||0.610|0.307|<0.0001
91509508|NCT01639001|182891089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.451|||<|0.0001|TWO_SIDED|95.0|3.79|11.11|||Mixed Models Analysis|||Analysis presented for QLQ-C30 Global QoL. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||11.11|3.79|<0.0001
91509509|NCT01639001|182891089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.613||||0.014|TWO_SIDED|95.0|0.73|6.49|||Mixed Models Analysis|||Analysis presented for QLQ-C30 cognitive functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.49|0.73|0.0140
91533072|NCT04955626|182943223|OTHER||Geometric mean ratio (GMR)|0.78|||||TWO_SIDED|95.0|0.38|1.59||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.59|0.38|
91509510|NCT01639001|182891089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.652||||0.2427|TWO_SIDED|95.0|-1.12|4.42|||Mixed Models Analysis|||Analysis presented for QLQ-C30 emotional functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||4.42|-1.12|0.2427
91509511|NCT01639001|182891089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7267|||<|0.0001|TWO_SIDED|95.0|4.15|9.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 physical functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||9.30|4.15|<0.0001
91509512|NCT01639001|182891089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.8109||||0.0003|TWO_SIDED|95.0|3.15|10.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 role functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.47|3.15|0.0003
91509513|NCT01639001|182891089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.594||||0.014|TWO_SIDED|95.0|1.13|10.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 social functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.06|1.13|0.0140
91509514|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.0432||||0.0016|TWO_SIDED|95.0|-9.79|-2.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 appetite loss. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-2.30|-9.79|0.0016
91509515|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.5026||||0.0263|TWO_SIDED|95.0|0.53|8.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 constipation. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||8.47|0.53|0.0263
91509516|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.8085|||<|0.0001|TWO_SIDED|95.0|12.94|18.68|||Mixed Models Analysis|||Analysis presented for QLQ-C30 diarrhea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||18.68|12.94|<0.0001
91509517|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.7449|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.19|||Mixed Models Analysis|||Analysis presented for QLQ-C30 dyspnea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-4.19|-11.30|<0.0001
91509518|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.4915||||0.0001|TWO_SIDED|95.0|-9.82|-3.17|||Mixed Models Analysis|||Analysis presented for QLQ-C30 fatigue. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.17|-9.82|0.0001
91533073|NCT04955626|182943223|OTHER||Geometric mean ratio (GMR)|0.66|||||TWO_SIDED|95.0|0.32|1.36||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.36|0.32|
91509519|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.6165||||0.2099|TWO_SIDED|95.0|-9.27|2.04|||Mixed Models Analysis|||Analysis presented for QLQ-C30 financial difficulties. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.04|-9.27|0.2099
91509520|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.7756||||0.0004|TWO_SIDED|95.0|-10.49|-3.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 insomnia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.06|-10.49|0.0004
91509521|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.519||||0.0902|TWO_SIDED|95.0|-5.43|0.4|||Mixed Models Analysis|||Analysis presented for QLQ-C30 nausea and vomiting. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.40|-5.43|0.0902
91509522|NCT01639001|182891090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.4349|||<|0.0001|TWO_SIDED|95.0|-11.42|-5.45|||Mixed Models Analysis|||Analysis presented for QLQ-C30 pain. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.45|-11.42|<0.0001
91509523|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.8547||||0.0039|TWO_SIDED|95.0|-8.15|-1.56|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 alopecia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.56|-8.15|0.0039
91509524|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.9957||||0.0004|TWO_SIDED|95.0|-10.85|-3.14|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 coughing. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.14|-10.85|0.0004
91509525|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5181||||0.7082|TWO_SIDED|95.0|-3.23|2.2|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dysphagia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.20|-3.23|0.7082
91755668|NCT02429791|183404351|OTHER|||||||0.048||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.048
91755669|NCT02429791|183404351|SUPERIORITY||Mean Difference (Final Values)|-1.569||||0.038|TWO_SIDED|95.0|-3.048|-0.09||P value to assess difference between treatment groups (Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.090|-3.048|0.038
91755670|NCT02429791|183404354|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.002
91755671|NCT02429791|183404354|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
91755672|NCT02429791|183404354|SUPERIORITY|||||||0.024||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.024
91755673|NCT02429791|183404354|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||<0.001
91755674|NCT02429791|183404354|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
91755675|NCT02429791|183404354|SUPERIORITY|||||||0.005||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.005
91755676|NCT02429791|183404354|SUPERIORITY|||||||0.063||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.063
91509526|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.6471|||<|0.0001|TWO_SIDED|95.0|-11.85|-5.44|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dyspnoea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.44|-11.85|<0.0001
91509527|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2504||||0.1284|TWO_SIDED|95.0|-2.86|0.36|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 haemoptysis. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.36|-2.86|0.1284
91509528|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2363||||0.0265|TWO_SIDED|95.0|-7.98|-0.49|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in arm or shoulder. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.49|-7.98|0.0265
91755677|NCT02429791|183404354|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.002
91755678|NCT02429791|183404354|SUPERIORITY|||||||0.099||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.099
91755679|NCT04201093|183404389|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.2|-13.8|<0.0001
91755680|NCT04201093|183404389|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.8|-14.4|<0.0001
91755681|NCT04201093|183404390|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.3|<0.0001
91755682|NCT04201093|183404390|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.4|<0.0001
91755683|NCT04201093|183404391|SUPERIORITY||Odds Ratio (OR)|6.148|||<|0.0001|TWO_SIDED|95.0|3.339|11.321|||Mixed Models Analysis|||||11.321|3.339|<0.0001
91755684|NCT04201093|183404391|SUPERIORITY||Odds Ratio (OR)|5.968|||<|0.0001|TWO_SIDED|95.0|3.22|11.062|||Mixed Models Analysis|||||11.062|3.220|<0.0001
91509529|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2237||||0.0185|TWO_SIDED|95.0|-7.74|-0.71|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in chest. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.71|-7.74|0.0185
91509530|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.5901||||0.0075|TWO_SIDED|95.0|-7.95|-1.23|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in other parts. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.23|-7.95|0.0075
91509531|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6732||||0.2848|TWO_SIDED|95.0|-4.74|1.39|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 peripheral neuropathy. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||1.39|-4.74|0.2848
91509532|NCT01639001|182891091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.398||||0.0296|TWO_SIDED|95.0|-4.56|-0.24|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 sore mouth. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.24|-4.56|0.0296
91509533|NCT01639001|182891092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9136||||0.0123|TWO_SIDED|95.0|0.85|6.98|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D VAS subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.98|0.85|0.0123
91509534|NCT01639001|182891093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0425||||0.032|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D Index score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.08|0.00|0.0320
91509535|NCT01639001|182891095|SUPERIORITY_OR_OTHER_LEGACY||Overall percent agreement|0.934|||||TWO_SIDED|95.0|0.914|0.949|||||95% CI for agreement rate is calculated by the Wilson (Score) Confidence Limit method with alpha=0.05|||0.949|0.914|
91509536|NCT01639001|182891095|SUPERIORITY_OR_OTHER_LEGACY||Kappa|0.847|||||TWO_SIDED|95.0|0.8065|0.8875|||||Kappa coefficient is a statistic which measures inter-rater agreement for qualitative (categorical) items.|||0.8875|0.8065|
91509537|NCT02610868|182891107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91533074|NCT04955626|182943224|OTHER||Geometric mean ratio (GMR)|0.75|||||TWO_SIDED|95.0|0.32|1.76||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||1.76|0.32|
91533075|NCT04955626|182943224|OTHER||Geometric mean ratio (GMR)|1.69|||||TWO_SIDED|95.0|0.74|3.85||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.85|0.74|
91509538|NCT02610868|182891107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509539|NCT02610868|182891107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509540|NCT02610868|182891107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509541|NCT02610868|182891107|SUPERIORITY|||||||0.0006|||||||ANCOVA|||||||0.0006
91509542|NCT02610868|182891107|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509543|NCT02610868|182891107|SUPERIORITY|||||||0.1131|||||||ANCOVA|||||||0.1131
91755685|NCT04201093|183404392|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.2|-13.8|<0.0001
91755686|NCT04201093|183404392|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.8|-14.4|<0.0001
91509544|NCT02610868|182891107|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
91509545|NCT02610868|182891107|SUPERIORITY|||||||0.2569|||||||ANCOVA|||||||0.2569
91509546|NCT02610868|182891108|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509547|NCT02610868|182891108|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509548|NCT02610868|182891108|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509549|NCT02610868|182891108|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509550|NCT02610868|182891108|SUPERIORITY|||||||0.313|||||||ANCOVA|||||||0.3130
91509551|NCT02610868|182891108|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509552|NCT02610868|182891108|SUPERIORITY|||||||0.1054|||||||ANCOVA|||||||0.1054
91509553|NCT02610868|182891108|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
91509554|NCT02610868|182891108|SUPERIORITY|||||||0.1663|||||||ANCOVA|||||||0.1663
91509555|NCT02610868|182891110|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509556|NCT02610868|182891110|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509557|NCT02610868|182891110|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509558|NCT02610868|182891110|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509559|NCT02610868|182891110|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.1100
91755687|NCT04201093|183404393|SUPERIORITY||LS Mean of Difference|-11.7|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-14.4|-9.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.1|-14.4|<0.0001
91509560|NCT02610868|182891110|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509561|NCT02610868|182891110|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.0000
91509562|NCT02610868|182891110|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509563|NCT02610868|182891110|SUPERIORITY|||||||0.029|||||||ANCOVA|||||||0.0290
91509564|NCT02610868|182891111|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509565|NCT02610868|182891111|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509566|NCT02610868|182891111|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509567|NCT02610868|182891111|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509568|NCT02610868|182891111|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509569|NCT02610868|182891111|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
91509570|NCT02610868|182891111|SUPERIORITY|||||||0.9016|||||||ANCOVA|||||||0.9016
91509571|NCT02610868|182891111|SUPERIORITY|||||||0.0753|||||||ANCOVA|||||||0.0753
91509572|NCT02610868|182891111|SUPERIORITY|||||||0.4992|||||||ANCOVA|||||||0.4992
91533076|NCT04955626|182943224|OTHER||Geometric mean ratio (GMR)|2.12|||||TWO_SIDED|95.0|0.92|4.91||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||4.91|0.92|
91509573|NCT02610868|182891112|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509574|NCT02610868|182891112|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509575|NCT02610868|182891112|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509576|NCT02610868|182891112|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509577|NCT02610868|182891112|SUPERIORITY|||||||0.4567|||||||ANCOVA|||||||0.4567
91509578|NCT02610868|182891112|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509579|NCT02610868|182891112|SUPERIORITY|||||||0.8115|||||||ANCOVA|||||||0.8115
91509580|NCT02610868|182891112|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509581|NCT02610868|182891112|SUPERIORITY|||||||0.3282|||||||ANCOVA|||||||0.3282
91509582|NCT02610868|182891114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509583|NCT02610868|182891114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509584|NCT02610868|182891114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509585|NCT02610868|182891114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509586|NCT02610868|182891114|SUPERIORITY|||||||0.3786|||||||ANCOVA|||||||0.3786
91755688|NCT04201093|183404393|SUPERIORITY||LS Mean of Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-14.7|-9.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.3|-14.7|<0.0001
91755689|NCT04201093|183404394|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.4822|TWO_SIDED|95.0|-1.0|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.5|-1.0|0.4822
91509587|NCT02610868|182891114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509588|NCT02610868|182891114|SUPERIORITY|||||||0.7787|||||||ANCOVA|||||||0.7787
91509589|NCT02610868|182891114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91509590|NCT02610868|182891114|SUPERIORITY|||||||0.3825|||||||ANCOVA|||||||0.3825
91509591|NCT02665481|182891152|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.07|-0.15|0.50
91509592|NCT02665481|182891152|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.18|TWO_SIDED|95.0|-0.04|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.19|-0.04|0.18
91509593|NCT02665481|182891152|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.17|-0.04|0.23
91509594|NCT02665481|182891152|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.47|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x Exercise (Month 0 and Month 18)||0.07|-0.15|0.47
91509595|NCT02665481|182891153|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED|95.0|-0.02|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.19|-0.02|0.12
91509596|NCT02665481|182891153|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.44|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.07|-0.15|0.44
91509597|NCT02665481|182891153|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.17|TWO_SIDED|95.0|-0.03|0.18|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.18|-0.03|0.17
91509598|NCT02665481|182891153|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.93|TWO_SIDED|95.0|-0.12|0.11|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.11|-0.12|0.93
91509599|NCT02665481|182891154|SUPERIORITY||Mean Difference (Final Values)|-3.46||||0.53|TWO_SIDED|95.0|-14.27|7.34|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||7.34|-14.27|0.53
91509600|NCT02665481|182891154|SUPERIORITY||Mean Difference (Final Values)|-20.16||||0.004|TWO_SIDED|95.0|-33.88|-6.44|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||-6.44|-33.88|0.004
91509601|NCT02665481|182891154|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.58|TWO_SIDED|95.0|-7.76|13.85|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||13.85|-7.76|0.58
91509602|NCT02665481|182891154|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.37|TWO_SIDED|95.0|-19.98|7.46|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||7.46|-19.98|0.37
91509603|NCT02665481|182891155|SUPERIORITY||Mean Difference (Final Values)|22.71||||0.33|TWO_SIDED|95.0|-22.95|68.36|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||68.36|-22.95|0.33
91509604|NCT02665481|182891155|SUPERIORITY||Mean Difference (Final Values)|25.35||||0.31|TWO_SIDED|95.0|-23.18|73.88|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||73.88|-23.18|0.31
91509605|NCT02665481|182891155|SUPERIORITY||Mean Difference (Final Values)|-17.18||||0.46|TWO_SIDED|95.0|-62.83|28.48|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||28.48|-62.83|0.46
91509606|NCT02665481|182891155|SUPERIORITY||Mean Difference (Final Values)|21.11||||0.39|TWO_SIDED|95.0|-27.41|69.64|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||69.64|-27.41|0.39
91509607|NCT02665481|182891156|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.37|TWO_SIDED|95.0|-0.02|0.01|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||0.01|-0.02|0.37
91509608|NCT02665481|182891156|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.1|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.00|-0.02|0.10
91509609|NCT02665481|182891156|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.21|TWO_SIDED|95.0|-0.004|0.02|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.02|-0.004|0.21
91509610|NCT02665481|182891156|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.09|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.00|-0.02|0.09
91509611|NCT02665481|182891157|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.57|TWO_SIDED|95.0|-0.38|0.69|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.69|-0.38|0.57
91509612|NCT02665481|182891157|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.58|0.55|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.55|-0.58|0.96
91509613|NCT02665481|182891157|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.37|TWO_SIDED|95.0|-0.78|0.29|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.29|-0.78|0.37
91509614|NCT02665481|182891157|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-0.57|0.57|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.57|-0.57|0.99
91509615|NCT02665481|182891158|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.19|TWO_SIDED|95.0|-0.47|2.33|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||2.33|-0.47|0.19
91509616|NCT02665481|182891158|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.09|TWO_SIDED|95.0|-0.19|2.77|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||2.77|-0.19|0.09
91509617|NCT02665481|182891158|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.42|TWO_SIDED|95.0|-1.97|0.83|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.83|-1.97|0.42
91509618|NCT02665481|182891158|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.54|TWO_SIDED|95.0|-1.01|1.94|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||1.94|-1.01|0.54
91509619|NCT02660359|182891173|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-8.97||||0.0001|TWO_SIDED|95.0|-13.5|-4.44|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-4.44|-13.5|0.0001
91509620|NCT02660359|182891173|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-9.76|||<|0.0001|TWO_SIDED|95.0|-14.41|-5.12|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.12|-14.41|<0.0001
91509621|NCT02660359|182891174|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|45.55||||0.0002|TWO_SIDED|95.0|6.09|340.69|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline- by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||340.69|6.09|0.0002
91509622|NCT02660359|182891174|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|31.69||||0.0009|TWO_SIDED|95.0|4.17|240.58|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||240.58|4.17|0.0009
91533077|NCT04955626|182943224|OTHER||Geometric mean ratio (GMR)|1.0|||||TWO_SIDED|95.0|0.43|2.33||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.33|0.43|
91509623|NCT02660359|182891175|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.55||||0.0007|TWO_SIDED|95.0|1.72|7.34||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||7.34|1.72|0.0007
91509624|NCT02660359|182891175|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.94||||0.0037|TWO_SIDED|95.0|1.43|6.07||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||6.07|1.43|0.0037
91509625|NCT02660359|182891175|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.03|7.79||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 600 U versus Placebo||7.79|2.03|<0.0001
91509626|NCT02660359|182891175|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by- visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.73||||0.0034|TWO_SIDED|95.0|1.4|5.33||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 800 U versus Placebo||5.33|1.40|0.0034
91533078|NCT04955626|182943224|OTHER||Geometric mean ratio (GMR)|0.89|||||TWO_SIDED|95.0|0.39|2.04||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.04|0.39|
91755690|NCT04201093|183404394|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7742|TWO_SIDED|95.0|-0.9|0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.6|-0.9|0.7742
91509627|NCT02660359|182891175|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|7.38|||<|0.0001|TWO_SIDED|95.0|3.5|15.58||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 600 U versus Placebo||15.58|3.5|<0.0001
91509628|NCT02660359|182891175|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.48|11.24||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 800 U versus Placebo||11.24|2.48|<0.0001
91533079|NCT04955626|182943225|OTHER||Geometric mean ratio (GMR)|0.99|||||TWO_SIDED|95.0|0.31|3.12||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.12|0.31|
91755691|NCT04201093|183404394|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.3|<0.0001
91755692|NCT04201093|183404394|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.4|<0.0001
91755693|NCT04201093|183404394|SUPERIORITY||LS Mean of Difference|-9.0|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-10.8|-7.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.3|-10.8|<0.0001
91755694|NCT04201093|183404394|SUPERIORITY||LS Mean of Difference|-9.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-11.2|-7.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.6|-11.2|<0.0001
91755695|NCT04201093|183404395|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.3|-0.6|<0.0001
91755696|NCT04201093|183404395|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.5|-0.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.2|-0.5|<0.0001
91755697|NCT04201093|183404396|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
91755698|NCT04201093|183404396|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.2|<0.0001
91755699|NCT04201093|183404397|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
91755700|NCT04201093|183404397|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.5|<0.0001
91755701|NCT04201093|183404398|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.6047|TWO_SIDED|95.0|-0.8|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.5|-0.8|0.6047
91509629|NCT02660359|182891177|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|96.14|||<|0.0001|TWO_SIDED|95.0|53.1|139.19|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||139.19|53.10|<0.0001
91509630|NCT02660359|182891177|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|90.78|||<|0.0001|TWO_SIDED|95.0|47.07|134.48|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||134.48|47.07|<0.0001
91509631|NCT02660359|182891178|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|175.0|||<|0.0001|TWO_SIDED|95.0|122.9|227.0|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||227.0|122.90|<0.0001
91509632|NCT02660359|182891178|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|168.4|||<|0.0001|TWO_SIDED|95.0|113.6|223.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||223.1|113.6|<0.0001
91509633|NCT02660359|182891179|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-41.5|-24.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-24.4|-41.5|<0.0001
91509634|NCT02660359|182891179|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-41.5|-23.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-23.4|-41.5|<0.0001
91509635|NCT02660359|182891180|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|152.8|||<|0.0001|TWO_SIDED|95.0|99.2|206.5|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||206.5|99.2|<0.0001
91509636|NCT02660359|182891180|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|169.7|||<|0.0001|TWO_SIDED|95.0|111.7|227.6|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||227.6|111.7|<0.0001
91509637|NCT02660359|182891181|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|31.1|||<|0.0001|TWO_SIDED|95.0|7.05|137.09|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||137.09|7.05|<0.0001
91509638|NCT02660359|182891181|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|28.08|||<|0.0001|TWO_SIDED|95.0|6.24|126.25|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by- visit interaction and study baseline weekly number of UI episodes as fixed effect.||126.25|6.24|<0.0001
91755702|NCT04201093|183404398|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.33||0.257|TWO_SIDED|95.0|-1.0|0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.3|-1.0|0.2570
91755703|NCT04201093|183404399|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8516|TWO_SIDED|95.0|-1.4|1.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.1|-1.4|0.8516
91509639|NCT00548808|182891203|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.4% for HbA1c was used.|Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.716|TWO_SIDED|95.0|-0.25|0.17|||ANCOVA|ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.17|-0.25|0.716
91509640|NCT00548808|182891204|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for 16 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.279
91755704|NCT04201093|183404399|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.6421|TWO_SIDED|95.0|-1.6|1.0||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.0|-1.6|0.6421
91509641|NCT00548808|182891204|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value for 32 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.846
91509642|NCT00548808|182891204|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.741
91533080|NCT04955626|182943225|OTHER||Geometric mean ratio (GMR)|4.57|||||TWO_SIDED|95.0|1.49|14.07||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||14.07|1.49|
91755705|NCT02596230|183404411|OTHER||Hazard Ratio (HR)|0.634||||0.188|TWO_SIDED|95.0|0.322|1.249||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.249|0.322|0.188
91755706|NCT02596230|183404412|OTHER||Hazard Ratio (HR)|0.778||||0.606|TWO_SIDED|95.0|0.3|2.017||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||2.017|0.300|0.606
91755707|NCT02596230|183404413|OTHER||Hazard Ratio (HR)|0.751||||0.542|TWO_SIDED|95.0|0.299|1.885||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.885|0.299|0.542
91755708|NCT02596230|183404414|OTHER||Hazard Ratio (HR)|0.0||||0.996|TWO_SIDED|95.0||||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|"Hazard Ratio \< 1 favors Dabigatran etexilate.~Hazard Ratio is actually \<0.01~95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events."|||||0.996
91755709|NCT02596230|183404415|OTHER||Hazard Ratio (HR)|0.857||||0.69|TWO_SIDED|95.0|0.402|1.828||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.828|0.402|0.690
91755710|NCT03270891|183404468|SUPERIORITY|Null hypothesis of equality.||||||0.0115|||||||t-test, 2 sided|||Baseline and 6 month values||||0.0115
91755711|NCT03270891|183404468|SUPERIORITY|Null hypothesis of equality.||||||0.027|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.027
91755712|NCT03270891|183404469|SUPERIORITY|Null hypothesis of equality.||||||0.0327|||||||t-test, 2 sided|||Baseline p value to six month||||0.0327
91755713|NCT03270891|183404469|SUPERIORITY|Null hypothesis of equality.||||||0.2088|||||||t-test, 2 sided|||baseline to 6 month comparison p value||||0.2088
91755714|NCT03270891|183404470|SUPERIORITY|Null hypothesis of equality.||||||0.947|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.947
91509643|NCT00548808|182891205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.465|TWO_SIDED|95.0|0.41|1.5||P-value for patients achieving HbA1c \<6.5% at 16 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.50|0.41|0.465
91533081|NCT04955626|182943225|OTHER||Geometric mean ratio (GMR)|7.3|||||TWO_SIDED|95.0|2.34|22.76||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||22.76|2.34|
91755715|NCT00849108|183404479|SUPERIORITY_OR_OTHER||sensitivity|0.769||||0.02|TWO_SIDED|95.0|0.655|0.884||P-Value for sensitivity comparison of PET MPI for the same reader|McNemar|two-sided McNemar test with 1 degree of freedom.|No standard deviation can be calculated for PET sensitivity|||0.884|0.655|0.02
91755716|NCT00849108|183404479|SUPERIORITY_OR_OTHER||Sensitivity|0.596||||0.02|TWO_SIDED|95.0|0.463|0.73||p-value for sensitivity comparison for SPECT MPI for the same reader|McNemar||No standard deviation can be calculated for SPECT sensitivity|||0.730|0.463|0.02
91755717|NCT00849108|183404481|SUPERIORITY_OR_OTHER||PET specificity|0.877||||0.317|TWO_SIDED|95.0|0.801|0.952||p-value for comparison of PET specificity for same reader|McNemar||no standard deviation for PET specficity|||0.952|0.801|0.317
91755718|NCT00849108|183404481|SUPERIORITY_OR_OTHER||SPECT specificity|0.836||||0.317|TWO_SIDED|95.0|0.751|0.921||p-value for comparison of SPECT specificity for same reader|McNemar||no standard deviation for SPECT specificity|||0.921|0.751|0.317
91755719|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||60.66|TWO_SIDED|95.0|0.85|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.85|60.66
91755720|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||95.21|TWO_SIDED|95.0|0.97|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|0.97|95.21
91755721|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||74.29|TWO_SIDED|95.0|0.88|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.88|74.29
91509644|NCT00548808|182891205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.365|TWO_SIDED|95.0|0.51|1.28||P-value for Patients Achieving HbA1c \<7% at 16 Weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.28|0.51|0.365
91509645|NCT00548808|182891205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.683|TWO_SIDED|95.0|0.65|1.95||P-value for patients achieving HbA1c \<6.5% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.95|0.65|0.683
91509646|NCT00548808|182891205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.81|TWO_SIDED|95.0|0.68|1.64||P-value for patients achieving HbA1c \<7% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.68|0.810
91509647|NCT00548808|182891205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.555|TWO_SIDED|95.0|0.69|2.01||P-value for patients achieving HbA1c \<6.5% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||2.01|0.69|0.555
91533082|NCT04955626|182943225|OTHER||Geometric mean ratio (GMR)|2.26|||||TWO_SIDED|95.0|0.72|7.1||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||7.10|0.72|
91755722|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||99.48|TWO_SIDED|95.0|1.06|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|1.06|99.48
91755723|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||13.98|TWO_SIDED|95.0|0.66|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.66|13.98
91755724|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.28||||97.92|TWO_SIDED|95.0|1.01|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|1.01|97.92
91755725|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||80.24|TWO_SIDED|95.0|0.84|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.84|80.24
91755726|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.3||||97.79|TWO_SIDED|95.0|1.01|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|1.01|97.79
91755727|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.27|TWO_SIDED|95.0|0.81|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.81|51.27
91759824|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.88|-0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-3.88|
91509648|NCT00548808|182891205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.829|TWO_SIDED|95.0|0.67|1.64||P-value for patients achieving HbA1c \<7% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.67|0.829
91533083|NCT04955626|182943225|OTHER||Geometric mean ratio (GMR)|1.28|||||TWO_SIDED|95.0|0.41|4.03||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||4.03|0.41|
91509649|NCT00548808|182891207|SUPERIORITY_OR_OTHER|||||||0.604||95.0||||P-value for Week 16 Change from Baseline|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.604
91509650|NCT00548808|182891207|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-value for Week 32 Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.814
91533084|NCT04955626|182943226|OTHER||Geometric mean ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.38|2.7||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.70|0.38|
91755728|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||90.66|TWO_SIDED|95.0|0.93|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.93|90.66
91755729|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.89|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|54.89
91755730|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.45|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.45
91755731|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.09|TWO_SIDED|95.0|0.98|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.98|94.09
91755732|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.95|TWO_SIDED|95.0|0.91|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.91|62.95
91755733|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||96.86|TWO_SIDED|95.0|0.99|1.26||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.26|0.99|96.86
91755734|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.16|TWO_SIDED|95.0|0.98|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.98|94.16
91755735|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.99|TWO_SIDED|95.0|0.86|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.86|48.99
91755736|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.51|TWO_SIDED|95.0|0.98|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.98|94.51
91755737|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||94.59|TWO_SIDED|95.0|0.97|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.97|94.59
91755738|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||61.27|TWO_SIDED|95.0|0.86|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.86|61.27
91759825|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.08|||||TWO_SIDED|95.0|-5.0|-1.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.00|
91509651|NCT00548808|182891207|SUPERIORITY_OR_OTHER|||||||0.582||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.582
91509652|NCT00548808|182891210|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.162|TWO_SIDED|95.0|-0.26|0.04||P-value for Cholesterol.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.04|-0.26|0.162
91533085|NCT04955626|182943226|OTHER||Geometric mean ratio (GMR)|1.99|||||TWO_SIDED|95.0|0.76|5.2||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||5.20|0.76|
91755739|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||96.63|TWO_SIDED|95.0|0.99|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.99|96.63
91755740|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.02|TWO_SIDED|95.0|0.97|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.97|94.02
91755741|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.24|TWO_SIDED|95.0|0.87|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.87|53.24
91755742|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.84|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|70.84
91755743|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||74.15|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|74.15
91755744|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||65.43|TWO_SIDED|95.0|0.87|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.87|65.43
91755745|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||97.15|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|97.15
91755746|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||63.99|TWO_SIDED|95.0|0.81|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.81|63.99
91533086|NCT04955626|182943226|OTHER||Geometric mean ratio (GMR)|2.99|||||TWO_SIDED|95.0|1.13|7.94||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||7.94|1.13|
91509653|NCT00548808|182891210|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.165|TWO_SIDED|95.0|-0.3|0.05||P-value for Triglycerides.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.05|-0.30|0.165
91509654|NCT00548808|182891210|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.51|TWO_SIDED|95.0|-0.18|0.09||P-value for Low Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.09|-0.18|0.510
91755747|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||91.99|TWO_SIDED|95.0|0.94|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.94|91.99
91755748|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.81|TWO_SIDED|95.0|0.94|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.94|76.81
91755749|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.01|TWO_SIDED|95.0|0.95|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.95|67.01
91755750|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||63.91|TWO_SIDED|95.0|0.85|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.85|63.91
91755751|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||96.47|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|96.47
91755752|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||72.17|TWO_SIDED|95.0|0.93|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.93|72.17
91755753|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||74.38|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|74.38
91755754|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.85|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|53.85
91755755|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||95.02|TWO_SIDED|95.0|0.98|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.98|95.02
91755756|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||92.27|TWO_SIDED|95.0|0.97|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.97|92.27
91509655|NCT00548808|182891210|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.382|TWO_SIDED|95.0|-0.02|0.06||P-value for High Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.06|-0.02|0.382
91509656|NCT00120042|182891237|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We planned that up to 300 women would be recruited. This sample size would achieve 80% poer at a 5% significance level to detect a reduction from 40% placental retention rate with no specific therapy (Group 1) to 20% with Group 2 or 3. An interim analysis was planned after 240 women had been recruited.||||0.05
91509657|NCT00120042|182891238|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91755757|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.65|TWO_SIDED|95.0|0.88|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.88|54.65
91759826|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.99|||||TWO_SIDED|95.0|-4.2|0.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-4.20|
91509658|NCT01126541|182891267|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided).||||||0.465|||||||Wilcoxon (Mann-Whitney)|||Change from Day 1 to Week 24 (initial treatment)||||0.465
91509659|NCT01126541|182891267|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Arm A vs. Arm B: Change from 1st retreatment to 24 weeks after||||0.161
91509660|NCT01126541|182891267|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.524|||||||Student t-test|||Arm A vs. Arm B: Change from 2nd retreatment to 24 weeks after||||0.524
91509661|NCT01126541|182891268|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean plus or minus (±)SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)|Adjusted difference|51.38|STANDARD_DEVIATION|92.0|||TWO_SIDED|95.0|-131.22|233.98|||||Covariate analysis with baseline DAS28-CRP value as covariate|||233.98|-131.22|
91509662|NCT01126541|182891288|SUPERIORITY_OR_OTHER|||||||0.389|||||||Wilcoxon (Mann-Whitney)|||Day 1 to Week 104||||0.389
91509663|NCT01126541|182891288|SUPERIORITY_OR_OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||1st retreatment to Week 104||||0.374
91509664|NCT01126541|182891288|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Weel 24 to Week 104||||0.277
91509665|NCT01126541|182891289|SUPERIORITY_OR_OTHER|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||Total cortisone: Week 24 to Week 104||||0.278
91509666|NCT01126541|182891289|SUPERIORITY_OR_OTHER|||||||0.887|||||||Wilcoxon (Mann-Whitney)|||Oral cortisone: Week 24 to Week 104||||0.887
91509667|NCT01126541|182891289|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||IV cortisone: Week 24 to Week 104||||<0.001
91509668|NCT04589559|182891313|OTHER|Paired-samples t-test|Mean change score|-1.5||||0.152|TWO_SIDED|95.0|-3.67|0.67|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in cardiac-related interoceptive fear.|||0.67|-3.67|0.152
91509669|NCT04589559|182891314|OTHER|Paired-samples t-test|Mean change score|-6.2||||0.031|TWO_SIDED|95.0|-11.71|-0.69|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in trait anxiety.|||-0.69|-11.71|0.031
91509670|NCT04589559|182891315|OTHER|Paired-samples t-test|Mean change score|-1.9||||0.323|TWO_SIDED|95.0|-6.01|2.21|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in negative affect.|||2.21|-6.01|0.323
91509671|NCT04589559|182891316|OTHER|Paired-samples t-test|Mean change in the measure|0.58||||0.112|TWO_SIDED|95.0|-0.16|1.33|||t-test, 2 sided|Paired-samples t-test|A positive value of the estimation parameter of mean change in the measure indicates an increase in heart rate variability.|||1.33|-0.16|0.112
91509672|NCT02664038|182891318|SUPERIORITY||Mean Difference (Final Values)|-2.82|STANDARD_ERROR_OF_MEAN|2.68|<|0.05|TWO_SIDED|0.05|-8.23|2.588|||ANCOVA|covaried for days of heavy drinking over the 30 days prior to randomization.||||2.588|-8.23|<.05
91509673|NCT02664038|182891319|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|0.05|-3.26|3.61|||ANCOVA|Days of heavy drinking 30 days prior to randomization||||3.61|-3.26|<.05
91509674|NCT02664038|182891320|SUPERIORITY||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|1.49||0.77|TWO_SIDED|0.05|1.45|4.43|||Mixed Models Analysis|Repeated measure with Baseline, 13 weeks and 26 weeks||||4.43|1.45|.77
91509675|NCT02664038|182891321|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.53|<|0.05|TWO_SIDED|95.0|-1.61|4.5|||Mixed Models Analysis|||||4.50|-1.61|<.05
91509676|NCT02664038|182891322|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.43||0.05|TWO_SIDED|0.05|0.19|1.11|||t-test, 2 sided|||||1.11|.19|.05
91509677|NCT04456699|182891369|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.9774|TWO_SIDED|95.0|1.0|1.97|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.97|1.00|0.9774
91509678|NCT04456699|182891369|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.9993|TWO_SIDED|95.0|1.23|2.49|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||2.49|1.23|0.9993
91533087|NCT04955626|182943226|OTHER||Geometric mean ratio (GMR)|1.8|||||TWO_SIDED|95.0|0.68|4.75||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||4.75|0.68|
91755758|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||87.93|TWO_SIDED|95.0|0.95|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.95|87.93
91533088|NCT04955626|182943226|OTHER||Geometric mean ratio (GMR)|0.84|||||TWO_SIDED|95.0|0.32|2.24||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||2.24|0.32|
91533089|NCT04955626|182943227|OTHER||Geometric mean ratio (GMR)|1.5|||||TWO_SIDED|95.0|0.44|5.12||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||5.12|0.44|
91759827|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.95|||||TWO_SIDED|95.0|-5.17|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-5.17|
91759828|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.44|||||TWO_SIDED|95.0|-5.65|-1.23||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.23|-5.65|
91759829|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.32|||||TWO_SIDED|95.0|-5.52|-1.12||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.12|-5.52|
91759830|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-4.6|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-4.60|
91759831|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.87|||||TWO_SIDED|95.0|-6.07|-1.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-6.07|
91759832|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.62|||||TWO_SIDED|95.0|-0.1|3.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.34|-0.10|
91759833|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.36|2.05||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-1.36|
91759834|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|||||TWO_SIDED|95.0|-0.94|2.48||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.48|-0.94|
91759835|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-2.01|1.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.38|-2.01|
91759836|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.17|||||TWO_SIDED|95.0|-0.79|3.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.12|-0.79|
91759837|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-1.1|2.82||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.82|-1.10|
91759838|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-1.19|2.72||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.72|-1.19|
91759839|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.24|1.66||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.66|-2.24|
91759840|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|||||TWO_SIDED|95.0|-0.16|3.67||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.67|-0.16|
91533090|NCT04955626|182943227|OTHER||Geometric mean ratio (GMR)|3.22|||||TWO_SIDED|95.0|0.99|10.46||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||10.46|0.99|
91755759|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||77.57|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|77.57
91755760|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.07|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|77.07
91755761|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||78.42|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|78.42
91755762|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.15|TWO_SIDED|95.0|0.93|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.93|44.15
91755763|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.79|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.79
91509679|NCT04456699|182891370|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1527|TWO_SIDED|95.0|0.54|1.21|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.21|0.54|0.1527
91509680|NCT04456699|182891370|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2491|TWO_SIDED|95.0|0.59|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.30|0.59|0.2491
91755764|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.51|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.51
91755765|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||93.16|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|93.16
91755766|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||73.7|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.70
91755767|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.04|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|81.04
91755768|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.58|TWO_SIDED|95.0|0.94|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.94|52.58
91755769|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||15.85|TWO_SIDED|95.0|0.86|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.86|15.85
91755770|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.69|TWO_SIDED|95.0|0.9|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.90|48.69
91755771|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.25|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|52.25
91755772|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||66.48|TWO_SIDED|95.0|0.91|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.91|66.48
91509681|NCT04456699|182891371|SUPERIORITY||Difference in Percentage|-0.2||||0.5272|TWO_SIDED|95.0|-7.0|6.5|||Miettinen and Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||6.5|-7.0|0.5272
91509682|NCT04456699|182891371|SUPERIORITY||Difference in Percentage|-3.2||||0.902|TWO_SIDED|95.0|-9.7|2.3|||Miettinen & Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||2.3|-9.7|0.9020
91509683|NCT05773287|182891375|SUPERIORITY|||||||0.509||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.509
91509684|NCT05773287|182891376|SUPERIORITY|||||||0.552||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.552
91509685|NCT00673452|182891391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.||Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of -0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.||||<0.001
91509686|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.19|-0.31||P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.19|<0.001
91509687|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.99|-0.24||P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.24|-0.99|0.001
91509688|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.13|-0.35||P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.35|-1.13|<0.001
91509689|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.2|-0.31||P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.20|<0.001
91509690|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.39|-0.49||P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.39|<0.001
91533091|NCT04955626|182943227|OTHER||Geometric mean ratio (GMR)|6.46|||||TWO_SIDED|95.0|1.96|21.27||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 OMI \[60 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||21.27|1.96|
91533092|NCT04955626|182943227|OTHER||Geometric mean ratio (GMR)|2.08|||||TWO_SIDED|95.0|0.63|6.89||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||6.89|0.63|
91755773|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||9.12|TWO_SIDED|95.0|0.72|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.72|9.12
91755774|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||16.95|TWO_SIDED|95.0|0.78|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.78|16.95
91755775|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||0.89|TWO_SIDED|95.0|0.75|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.75|0.89
91755776|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.4|TWO_SIDED|95.0|0.86|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.86|50.40
91755777|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||7.44|TWO_SIDED|95.0|0.76|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.76|7.44
91755778|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||56.35|TWO_SIDED|95.0|0.87|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.87|56.35
91755779|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.87|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.87|4.03
91755780|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.79|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|24.79
91755781|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.08|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|77.08
91755782|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||23.07|TWO_SIDED|95.0|0.89|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.89|23.07
91755783|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||18.58|TWO_SIDED|95.0|0.88|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.88|18.58
91533093|NCT04955626|182943227|OTHER||Geometric mean ratio (GMR)|0.95|||||TWO_SIDED|95.0|0.28|3.17||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the difference in LS means (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of baseline assay results (log scale) and vaccine group.||3.17|0.28|
91533094|NCT04955626|182943252|OTHER||Adjusted Surveillance Time|100.0|||||TWO_SIDED|95.0|-358.6|100.0||||||||100.0|-358.6|
91533095|NCT04955626|182943253|OTHER||Adjusted Surveillance Time|100.0|||||TWO_SIDED|95.0|-355.5|100.0||||||2-Sided CI for RVE is derived based on the Clopper and Pearson method adjusted for surveillance time.||100.0|-355.5|
91533096|NCT04955626|182943262|OTHER||Geometric mean ratio (GMR)|0.99|||||TWO_SIDED|95.0|0.82|1.2||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 \[15 mcg\] + BNT162b2 OMI \[15 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.||1.20|0.82|
91533097|NCT04955626|182943262|OTHER||Geometric mean ratio (GMR)|1.3|||||TWO_SIDED|95.0|1.07|1.58||||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (BNT162b2 \[30 mcg\] + BNT162b2 OMI \[30 mcg\] - BNT162b2 \[30 mcg\]) and the corresponding CIs based on the student t distribution.||1.58|1.07|
91533098|NCT03714022|182943270|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.998|||||TWO_SIDED|90.0|0.941|1.058|||||Cohort A vs Cohort B|||1.058|0.941|
91509691|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.41|<0.001
91509692|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.24|-0.36||P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.36|-1.24|<0.001
91509693|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.21|<0.001
91509694|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.38|-0.52||P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.38|<0.001
91509695|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.39|-1.35|<0.001
91533099|NCT03714022|182943271|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.929|||||TWO_SIDED|90.0|0.884|0.976|||||Cohort A vs Cohort B|||0.976|0.884|
91533100|NCT03714022|182943273|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.936|||||TWO_SIDED|90.0|0.891|0.983|||||Cohort A vs Cohort B|||0.983|0.891|
91533101|NCT03714022|182943274|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.957|||||TWO_SIDED|90.0|0.915|1.001|||||Cohort A vs Cohort B|||1.001|0.915|
91533102|NCT02487446|182943330|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL.|Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778||0.139|TWO_SIDED|95.0|-0.0269|0.0038||p-value unadjusted|Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|0.139
91533103|NCT02487446|182943331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778|||TWO_SIDED|95.0|-0.0269|0.0038||||||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|
91533104|NCT02487446|182943332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0153|STANDARD_ERROR_OF_MEAN|0.01062|||TWO_SIDED|95.0|-0.0361|0.0056||||||||0.0056|-0.0361|
91533105|NCT02487446|182943333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0051|STANDARD_ERROR_OF_MEAN|0.00806|||TWO_SIDED|95.0|-0.0108|0.0209||||||||0.0209|-0.0108|
91533106|NCT04951479|182943350|SUPERIORITY|||||||0.00041|||||||t-test, 2 sided|||Paired t-test of KOOS Pain score pre and 6 months post embolization||||0.00041
91533107|NCT04951479|182943351|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
91533108|NCT04951479|182943352|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91533109|NCT04951479|182943353|SUPERIORITY|||||||0.00797|||||||t-test, 2 sided|paired t-test||||||0.00797
91533110|NCT03706690|182943355|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.038|TWO_SIDED|95.0|0.578|0.986|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for the level of programmed death ligand 1 (PD-L1) expression (PD-L1 \<1% versus \[vs\] PD-L1 \>=1%) and prior therapy (concurrent \[c\]CRT vs sequential \[s\]CRT), with treatment as the only covariate and ties handled by Efron approach.||0.986|0.578|0.038
91533111|NCT03706690|182943356|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.656|1.166|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.166|0.656|0.346
91509696|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.92|-0.86||P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.86|-1.92|<0.001
91509697|NCT00673452|182891392|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.52||P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.33|<0.001
91509698|NCT00673452|182891393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83||||0.005|TWO_SIDED|95.0|-1.41|-0.25||P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.41|0.005
91509699|NCT00673452|182891393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.013|TWO_SIDED|95.0|-1.3|-0.15||P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.15|-1.30|0.013
91509700|NCT00673452|182891393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92||||0.003|TWO_SIDED|95.0|-1.52|-0.32||P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.52|0.003
91509701|NCT00673452|182891393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88||||0.005|TWO_SIDED|95.0|-1.49|-0.26||P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.26|-1.49|0.005
91509702|NCT00673452|182891393|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.49|-0.38||P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.38|-1.49|<0.001
91509703|NCT00673452|182891394|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.89||||0.007|TWO_SIDED|95.0|-3.25|-0.53||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.53|-3.25|0.007
91755784|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||44.94|TWO_SIDED|95.0|0.92|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.92|44.94
91509704|NCT00673452|182891395|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.51|-0.16||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.16|-0.51|<0.001
91509705|NCT00673452|182891396|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07||||0.907|TWO_SIDED|95.0|-1.13|1.27||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.27|-1.13|0.907
91509706|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.22||||0.003|TWO_SIDED|95.0|1.76|8.67||P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.67|1.76|0.003
91509707|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.42|||<|0.001|TWO_SIDED|95.0|3.41|9.43||P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||9.43|3.41|<0.001
91509708|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.44|||<|0.001|TWO_SIDED|95.0|4.41|10.47||P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.47|4.41|<0.001
91509709|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47||||0.002|TWO_SIDED|95.0|2.06|8.88||P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.88|2.06|0.002
91755785|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||2.21|TWO_SIDED|95.0|0.8|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.80|2.21
91533112|NCT03706690|182943356|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.663|1.162|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.162|0.663|0.346
91755786|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.09|TWO_SIDED|95.0|0.83|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.83|6.09
91755787|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||66.6|TWO_SIDED|95.0|0.92|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.92|66.60
91755788|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||3.23|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.23
91755789|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||20.83|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|20.83
91755790|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.6|TWO_SIDED|95.0|0.96|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.96|87.60
91755791|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||7.9|TWO_SIDED|95.0|0.84|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.84|7.90
91755792|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.39|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.39
91755793|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.16|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|76.16
91755794|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||22.54|TWO_SIDED|95.0|0.87|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.87|22.54
91533113|NCT03706690|182943357|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.026|TWO_SIDED|95.0|0.575|0.966|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1\>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||0.966|0.575|0.026
91533114|NCT03706690|182943359|SUPERIORITY||Odds Ratio (OR)|1.51||||0.128|TWO_SIDED|95.0|0.891|2.607|||Regression, Logistic|||For mITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.607|0.891|0.128
91533115|NCT03706690|182943359|SUPERIORITY||Odds Ratio (OR)|1.54||||0.105|TWO_SIDED|95.0|0.915|2.638|||Regression, Logistic|||For ITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.638|0.915|0.105
91533116|NCT03706690|182943362|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.275|TWO_SIDED|95.0|0.648|1.138|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.138|0.648|0.275
91533117|NCT03706690|182943362|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.241|TWO_SIDED|95.0|0.648|1.122|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.122|0.648|0.241
91755795|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||58.17|TWO_SIDED|95.0|0.91|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.91|58.17
91755796|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||6.22|TWO_SIDED|95.0|0.76|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.76|6.22
91509710|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.78||||0.004|TWO_SIDED|95.0|3.11|16.45||P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||16.45|3.11|0.004
91509711|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.59||||0.632|TWO_SIDED|95.0|-4.93|8.11||P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.11|-4.93|0.632
91509712|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.67|||<|0.001|TWO_SIDED|95.0|2.73|10.61||P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.61|2.73|<0.001
91509713|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.31||||0.015|TWO_SIDED|95.0|0.84|7.79||P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||7.79|0.84|0.015
91509714|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.14||||0.134|TWO_SIDED|95.0|-0.35|2.64||P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||2.64|-0.35|0.134
91509715|NCT00673452|182891397|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.83|||<|0.001|TWO_SIDED|95.0|2.05|5.6||P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||5.60|2.05|<0.001
91755797|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.85|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.85
91533118|NCT03706690|182943363|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.769|TWO_SIDED|95.0|0.726|1.578|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.578|0.726|0.769
91509716|NCT00673452|182891398|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.083|TWO_SIDED|95.0|-2.05|0.13||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||0.13|-2.05|0.083
91509717|NCT00673452|182891399|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.18|-0.32||P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.18|<0.001
91509718|NCT00673452|182891399|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.003|TWO_SIDED|95.0|-1.05|-0.22||P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.22|-1.05|0.003
91509719|NCT00673452|182891399|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.003|TWO_SIDED|95.0|-1.19|-0.25||P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.19|0.003
91509720|NCT00673452|182891399|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.05|TWO_SIDED|95.0|-0.97|0.0||P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.00|-0.97|0.050
91509721|NCT00673452|182891399|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.43|-1.32|<0.001
91509722|NCT00673452|182891400|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.002
91509723|NCT00673452|182891401|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.003
91509724|NCT00673452|182891402|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.82||||0.084|TWO_SIDED|95.0|-0.25|3.88||P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.88|-0.25|0.084
91509725|NCT00673452|182891402|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52||||0.434|TWO_SIDED|95.0|-0.79|1.84||P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.84|-0.79|0.434
91509726|NCT00673452|182891403|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96||||0.003|TWO_SIDED|95.0|0.67|3.26||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.26|0.67|0.003
91509727|NCT00673452|182891404|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||1.00
91509728|NCT00673452|182891405|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.21|-0.45||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.45|-1.21|<0.001
91509729|NCT03037528|182891428|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||.214
91509730|NCT03037528|182891428|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||.017
91509731|NCT03037528|182891428|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||||||.457
91509732|NCT03037528|182891428|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||.580
91509733|NCT03037528|182891428|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||.275
91509734|NCT03037528|182891428|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
91509735|NCT03037528|182891428|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
91509736|NCT03037528|182891428|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
91509737|NCT03037528|182891429|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||.027
91509738|NCT03037528|182891429|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
91509739|NCT03037528|182891429|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||.054
91509740|NCT03037528|182891429|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||.014
91509741|NCT03037528|182891429|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
91509742|NCT03037528|182891429|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||||||.026
91509743|NCT03037528|182891429|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||.013
91509744|NCT03037528|182891429|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
91509745|NCT03037528|182891430|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||.018
91509746|NCT03037528|182891430|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
91755798|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.44|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|25.44
91755799|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||18.15|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|18.15
91759841|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12|||||TWO_SIDED|95.0|-0.81|3.04||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.04|-0.81|
91509747|NCT03037528|182891430|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||||||.134
91509748|NCT03037528|182891430|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91509749|NCT03037528|182891430|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
91509750|NCT03037528|182891430|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
91509751|NCT03037528|182891430|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||||||.045
91509752|NCT03037528|182891430|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
91533119|NCT03706690|182943363|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.812|TWO_SIDED|95.0|0.726|1.539|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.539|0.726|0.812
91533120|NCT02711826|182943372|SUPERIORITY|||||||0.425|||||||Fisher Exact|||||||0.425
91759842|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.26|2.57||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.57|-1.26|
91509753|NCT02908529|182891431|SUPERIORITY||Median Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91509754|NCT04497987|182891433|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.63|||Regression, Logistic|||||0.63|0.26|<0.001
91509755|NCT04497987|182891434|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.27|0.67|||Regression, Logistic|||||0.67|0.27|<0.001
91509756|NCT04497987|182891435|SUPERIORITY||Odds Ratio (OR)|0.66||||0.021|TWO_SIDED|95.0|0.46|0.94|||Regression, Logistic|||||0.94|0.46|0.021
91509757|NCT04099524|182891440|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|-0.18|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
91509758|NCT04099524|182891440|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||||||<0.05
91509759|NCT04099524|182891441|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|chi-square|3.14|||<|0.05|TWO_SIDED||||||Chi-squared|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
91509760|NCT04099524|182891442|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
91509761|NCT04099524|182891443|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.84|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||||<0.05
91509762|NCT04733157|182891444|OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|0.69|1.09||Threshold for statistical significance was 0.05|Chi-squared|||||1.09|0.69|0.33
91509763|NCT01966926|182891479|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|chi square|2.05||||0.15|TWO_SIDED|||||P-value was unadjusted, with an a priori threshold for statistical significance set at p \<.05.|Chi-squared|1 degree of freedom||||||.15
91509764|NCT01966926|182891480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.96||||0.61||||||P-value not adjusted for multiple comparisons; a priori threshold of \<0.05 for statistical significance|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.61
91509765|NCT01966926|182891481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.95||||0.5||||||P-value is unadjusted; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.50
91509766|NCT01966926|182891482|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.87||||0.15||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.15
91509767|NCT01966926|182891483|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.91||||0.3||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,26||Repeated measures analysis from baseline to six months.||||0.30
91755800|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||8.12|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|8.12
91509768|NCT01966926|182891484|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.93||||0.17||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 1,28||Repeated measures analysis from three to six months.||||0.17
91509769|NCT01694706|182891600|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|120.35|STANDARD_DEVIATION|23.2||0.342|TWO_SIDED|90.0|102.09|141.88|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||141.88|102.09|0.3420
91509770|NCT01694706|182891600|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.33|STANDARD_DEVIATION|30.8||0.0962|TWO_SIDED|90.0|76.21|116.76|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||116.76|76.21|0.0962
91509771|NCT01694706|182891601|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|118.79|STANDARD_DEVIATION|52.4||0.3993|TWO_SIDED|90.0|83.19|169.628|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||169.628|83.190|0.3993
91509772|NCT01694706|182891601|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|93.55|STANDARD_DEVIATION|53.0||0.2204|TWO_SIDED|90.0|65.783|133.03|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||133.030|65.783|0.2204
91509773|NCT01694706|182891602|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|121.28|STANDARD_DEVIATION|24.0||0.3765|TWO_SIDED|90.0|102.32|143.74|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||143.74|102.32|0.3765
91509774|NCT01694706|182891602|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.72|STANDARD_DEVIATION|31.4||0.0946|TWO_SIDED|90.0|76.25|117.67|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||117.67|76.25|0.0946
91509775|NCT00451282|182891603|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
91533121|NCT02711826|182943373|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||||||0.700
91533122|NCT02711826|182943374|SUPERIORITY|||||||0.201|||||||Kruskal-Wallis|||||||0.201
91509776|NCT00451282|182891604|SUPERIORITY_OR_OTHER|||||||0.89|||||||t-test, 2 sided|||||||.89
91509777|NCT00451282|182891605|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
91509778|NCT00451282|182891606|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||.18
91509779|NCT01797536|182891610|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR= Mild Hepatic Insufficiency Geometric Mean (GM) divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
91509780|NCT01797536|182891610|SUPERIORITY_OR_OTHER||GMR|0.72|||||TWO_SIDED|90.0|0.4|1.31|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.31|0.40|
91509781|NCT01797536|182891610|SUPERIORITY_OR_OTHER||GMR|0.88|||||TWO_SIDED|90.0|0.48|1.61|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.61|0.48|
91509782|NCT01797536|182891611|SUPERIORITY_OR_OTHER||GMR|0.6|||||TWO_SIDED|90.0|0.34|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.34|
91509783|NCT01797536|182891611|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
91509784|NCT01797536|182891611|SUPERIORITY_OR_OTHER||GMR|0.63|||||TWO_SIDED|90.0|0.35|1.13|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.13|0.35|
91509785|NCT01797536|182891612|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.32|
91509786|NCT01797536|182891612|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
91509787|NCT01797536|182891612|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.08|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.32|
91509788|NCT01797536|182891613|SUPERIORITY_OR_OTHER||GMR|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
91533123|NCT00729690|182943396|SUPERIORITY_OR_OTHER|||||||0.4742||95.0|||||ANOVA|||For 1st 24 hours NRS AUC Pain scores||||0.4742
91755801|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.39|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.39
91509789|NCT01797536|182891613|SUPERIORITY_OR_OTHER||GMR|0.69|||||TWO_SIDED|90.0|0.38|1.25|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.25|0.38|
91755802|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||10|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|10.00
91509790|NCT01797536|182891613|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.43|1.43|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.43|0.43|
91509791|NCT00456092|182891620|SUPERIORITY||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.72|10.2||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||10.20|1.72|0.002
91509792|NCT00456092|182891620|SUPERIORITY||Odds Ratio (OR)|5.77|||<|0.001|TWO_SIDED|95.0|2.4|13.88||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||13.88|2.40|< 0.001
91509793|NCT00456092|182891623|SUPERIORITY||Odds Ratio (OR)|5.12||||0.056|TWO_SIDED|95.0|1.06|24.67|||Chi-squared, Corrected|||||24.67|1.06|0.056
91533124|NCT00729690|182943397|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANOVA|||||||0.7596
91533125|NCT00729690|182943398|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||ANOVA|||||||0.4321
91509794|NCT00456092|182891623|SUPERIORITY||Odds Ratio (OR)|6.95||||0.012|TWO_SIDED|95.0|1.49|32.35|||Chi-squared, Corrected|||||32.35|1.49|0.012
91509795|NCT00456092|182891624|SUPERIORITY||Odds Ratio (OR)|5.4||||0.204|TWO_SIDED|95.0|0.61|47.54|||Chi-squared, Corrected|||||47.54|0.61|0.204
91509796|NCT00456092|182891624|SUPERIORITY||Odds Ratio (OR)|4.12||||0.371|TWO_SIDED|95.0|0.45|37.88|||Chi-squared, Corrected|||||37.88|0.45|0.371
91509797|NCT00456092|182891625|SUPERIORITY||Odds Ratio (OR)|1.568||||0.264|TWO_SIDED|95.0|0.79|3.11|||Chi-squared, Corrected|||||3.11|0.79|0.264
91509798|NCT00456092|182891625|SUPERIORITY||Odds Ratio (OR)|1.98||||0.071|TWO_SIDED|95.0|1.0|3.91|||Chi-squared, Corrected|||||3.91|1.00|0.071
91509799|NCT00456092|182891626|SUPERIORITY||Odds Ratio (OR)|1.305||||0.549|TWO_SIDED|95.0|0.66|2.57|||Chi-squared, Corrected|||||2.57|0.66|0.549
91509800|NCT00456092|182891626|SUPERIORITY||Odds Ratio (OR)|1.033||||1|TWO_SIDED|95.0|0.53|2.03|||Chi-squared, Corrected|||||2.03|0.53|1.000
91509801|NCT00456092|182891627|SUPERIORITY||Odds Ratio (OR)|2.06||||0.083|TWO_SIDED|95.0|0.98|4.34|||Chi-squared, Corrected|||||4.34|0.98|0.083
91509802|NCT00456092|182891627|SUPERIORITY||Odds Ratio (OR)|1.63||||0.279|TWO_SIDED|95.0|0.77|3.44|||Chi-squared, Corrected|||||3.44|0.77|0.279
91509803|NCT00456092|182891628|SUPERIORITY||Odds Ratio (OR)|1.32||||0.548|TWO_SIDED|95.0|0.66|2.66|||Chi-squared, Corrected|||||2.66|0.66|0.548
91509804|NCT00456092|182891628|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.52|2.11|||Chi-squared, Corrected|||||2.11|0.52|1.000
91509805|NCT00456092|182891631|SUPERIORITY||Treatment Difference|11.58||||0.136|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.136
91509806|NCT00456092|182891631|SUPERIORITY||Treatment Difference|13.53||||0.08|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.080
91509807|NCT00456092|182891632|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.745|1.211|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||1.211|0.745|0.650
91533126|NCT00729690|182943399|SUPERIORITY_OR_OTHER|||||||0.9361||95.0|||||ANOVA|||||||0.9361
91509808|NCT00456092|182891632|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.283|TWO_SIDED|95.0|0.791|2.024|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.024|0.791|0.283
91509809|NCT00456092|182891633|SUPERIORITY||Hazard Ratio (HR)|1.337||||0.253|TWO_SIDED|95.0|0.791|2.26|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.260|0.791|0.253
91509810|NCT00456092|182891633|SUPERIORITY||Hazard Ratio (HR)|3.023||||0.026|TWO_SIDED|95.0|1.059|8.63|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||8.630|1.059|0.026
91509811|NCT00456092|182891634|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.984|TWO_SIDED|95.0|0.457|2.215|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.215|0.457|0.984
91509812|NCT00456092|182891634|SUPERIORITY||Hazard Ratio (HR)|0.872||||0.836|TWO_SIDED|95.0|0.158|4.797|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||4.797|0.158|0.836
91509813|NCT00456092|182891639|SUPERIORITY||Adjusted Mean Difference|1.4||||0.308|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.308
91509814|NCT00456092|182891639|SUPERIORITY||Adjusted Mean Difference|4.1||||0.003|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.003
91755803|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.88|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|29.88
91755804|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||12.63|TWO_SIDED|95.0|0.89|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.89|12.63
91759843|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.57|2.25||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.25|-1.57|
91759844|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.31|4.07||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.07|-0.31|
91509815|NCT00456092|182891639|SUPERIORITY||Adjusted Mean Difference|1.6||||0.182|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.182
91509816|NCT00456092|182891639|SUPERIORITY||Adjusted Mean Difference|2.7||||0.026|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.026
91509817|NCT00456092|182891640|SUPERIORITY||Adjusted Mean Difference|-2.1||||0.016|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.016
91509818|NCT00456092|182891640|SUPERIORITY||Adjusted Mean Difference|-1.4||||0.105|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.105
91509819|NCT00456092|182891642|SUPERIORITY||Adjusted Mean Difference|3.3||||0.028|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.028
91509820|NCT00456092|182891642|SUPERIORITY||Adjusted Mean Difference|4.3||||0.004|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.004
91509821|NCT04875520|182891664|NON_INFERIORITY|Overall rate compared using GEE model includes any person affiliated with the school who tested positive at least once during the study period that the schools reported to us that were positive. This includes people in our testing program and not in our testing program.|Mean Difference (Final Values)|-0.01845||||0.25|TWO_SIDED|95.0|-0.04981|0.01292|||generalized estimating equations|||||0.01292|-0.04981|0.25
91509822|NCT04646616|182891738|NON_INFERIORITY|This is a single-group, of outcome measured at baseline and at 3 months. We hypothesized there would be an improvement or sustainability of the protective behaviours.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.12|0.39|||t-test, 2 sided|||This is a single-group study. Selected outcomes were measured at baseline (first interaction with the community popular opinion leader (POL) and 3 months after.||0.39|-0.12|0.28
91509823|NCT04646616|182891739|OTHER|Test of proportions|difference in proportion|-0.007|STANDARD_ERROR_OF_MEAN|0.04||0.85|TWO_SIDED|95.0|-0.08|0.07|||Test of proportions|||Two sample test of proportions, testing whether the proportion of participants who lack health access at baseline and 3 months is equal (null hypothesis)||0.07|-0.08|0.85
91509824|NCT04646616|182891740|OTHER|Test of proportions.|difference in proportion|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.19|TWO_SIDED|95.0|-0.04|0.19|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who had a SAVAME factor at baseline and 3 months is equal (null hypothesis)||0.19|-0.04|0.19
91509825|NCT04646616|182891741|OTHER|Test of proportions.|difference in proportion|0.067|STANDARD_ERROR_OF_MEAN|0.06||0.23|TWO_SIDED|95.0|-0.04|0.18|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who lack access to SAVAME related services at baseline and 3 months is equal (null hypothesis)||0.18|-0.04|0.23
91509826|NCT03049813|182891745|SUPERIORITY|||||||0.027||||||One-sided p value|Regression, Logistic|Adjusted for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms - anergia||||||0.027
91509827|NCT03049813|182891745|SUPERIORITY|||||||0.0765||||||1-sided p-value|Chi-squared|||||||0.0765
91755805|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.29|TWO_SIDED|95.0|0.91|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.91|32.29
91755806|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||69.92|TWO_SIDED|95.0|0.95|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.95|69.92
91755807|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||6.1|TWO_SIDED|95.0|0.84|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.84|6.10
91755808|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||33.63|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|33.63
91755809|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||86.07|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.07
91509828|NCT03049813|182891746|SUPERIORITY|||||||0.062||||||One-sided p value|Regression, Cox|Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms anergia||||||0.062
91509829|NCT03049813|182891747|SUPERIORITY|||||||0.006||||||Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, negative symptoms - anergia|Regression, Linear|||||||0.006
91509830|NCT03049813|182891748|SUPERIORITY|||||||0.013||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One-sided p value.|Regression, Linear|||||||0.013
91509831|NCT03049813|182891749|SUPERIORITY|||||||0.019||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One sided p-value.|Regression, Linear|||||||0.019
91509832|NCT03049813|182891750|SUPERIORITY|||||||0.692||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia).|Regression, Linear|||For this analysis, only participants who completed both pre-test and posttest were included. If someone completed a pre-test SSPA, but not a posttest SSPA, they were not included in the analysis.||||0.692
91509833|NCT02144675|182891755|OTHER||||||<|0.05|||||||Regression, Cox|||||||<.05
91509834|NCT01813019|182891785|SUPERIORITY_OR_OTHER|||||||0.671|||||||Mixed Models Analysis|||||||0.671
91509835|NCT01458171|182891803|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.45||||||||0.450||
91509836|NCT01458171|182891803|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.523||||||||0.523||
91509837|NCT01192152|182891824|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares means|1.045|||||TWO_SIDED|90.0|1.025|1.065|||||Ratio = Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.065|1.025|
91509838|NCT01192152|182891824|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|103.05||||||95.0||||||||Geometric least squares means for Treatment B||||
91509839|NCT01192152|182891824|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|98.61||||||95.0||||||||Geometric least squares means for Treatment A||||
91509840|NCT01192152|182891825|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.035|||||TWO_SIDED|90.0|1.009|1.062|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.062|1.009|
91509841|NCT01192152|182891825|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|101.16||||||95.0||||||||Geometric least squares means for Treatment B||||
91509842|NCT01192152|182891825|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|97.72||||||95.0||||||||Geometric least squares means for Treatment A||||
91509843|NCT01192152|182891827|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares mean|0.999|||||TWO_SIDED|90.0|0.948|1.053|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.053|0.948|
91533127|NCT02507219|182943408|SUPERIORITY||Slope|0.000055||||0.512|TWO_SIDED|95.0|-0.00011|0.00022|||Mixed Models Analysis||Slope is percent signal change per milligram of ibuprofen.|A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.00022|-0.00011|0.512
91533128|NCT02507219|182943408|SUPERIORITY||Slope|-0.00012||||0.221|TWO_SIDED|95.0|-0.0003|0.000067|||Mixed Models Analysis||Slope is the percent signal change per mg of ibuprofen.|A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.000067|-0.00030|0.221
91533129|NCT02624778|182943429|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.07||0.309|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||||0.07|-0.21|0.309
91533130|NCT02624778|182943429|SUPERIORITY||LS Mean|-0.133|STANDARD_ERROR_OF_MEAN|0.07||0.061|TWO_SIDED|95.0|-0.27|0.01|||Mixed Models Analysis|||||0.01|-0.27|0.061
91759845|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|||||TWO_SIDED|95.0|-1.28|3.13||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.13|-1.28|
91509844|NCT01192152|182891827|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.85||||||95.0||||||||Geometric least squares means for Treatment B||||
91509845|NCT01192152|182891827|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.88||||||95.0||||||||Geometric least squares means for Treatment A||||
91509846|NCT01192152|182891844|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.894|||||TWO_SIDED|90.0|0.833|0.959|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.959|0.833|
91509847|NCT01192152|182891844|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|8713.4||||||95.0||||||||Geometric least squares mean for Treatment B||||
91509848|NCT01192152|182891844|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|9746.3||||||95.0||||||||Geometric least squares mean for Treatment A||||
91509849|NCT01192152|182891845|SUPERIORITY_OR_OTHER||ratio of geometric least squares means|0.906|||||TWO_SIDED|90.0|0.848|0.968|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.968|0.848|
91509850|NCT01192152|182891845|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|8377.8||||||95.0||||||||Geometric least squares means for Treatment B||||
91509851|NCT01192152|182891845|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|9246.8||||||95.0||||||||Geometric least squares mean for Treatment A||||
91513426|NCT02328326|182898556|SUPERIORITY||Mean Difference (Net)|0.32||||0.5|TWO_SIDED|95.0|-0.61|1.25|||Regression, Linear|Model was adjusted for baseline value of PAID\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baselineNet difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID\_CP score compared to patient participants in PACT.||1.25|-0.61|0.50
91513427|NCT04289753|182898562|SUPERIORITY||Odds Ratio (OR)|0.56|||||TWO_SIDED|95.0|0.46|0.69||||||||0.69|0.46|
91509852|NCT01192152|182891847|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.917|||||TWO_SIDED|90.0|0.859|0.98|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.980|0.859|
91509853|NCT01192152|182891847|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1055.9||||||95.0||||||||Geometric least squares means for Treatment B||||
91509854|NCT01192152|182891847|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1151.2||||||95.0||||||||Geometric least squares means for Treatment A||||
91509855|NCT03022617|182891856|SUPERIORITY||Mean Difference (Final Values)|21.5|STANDARD_DEVIATION|10.89||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
91509856|NCT01339390|182891866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3941|STANDARD_ERROR_OF_MEAN|0.5759||0.4937|TWO_SIDED|95.0|-0.7347|1.5229||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.5229|-.7347|0.4937
91509857|NCT01339390|182891866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5893|STANDARD_ERROR_OF_MEAN|0.5759||0.3062|TWO_SIDED|95.0|-0.5395|1.7181||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.7181|-0.5395|0.3062
91509858|NCT00378703|182891867|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm B (bevacizumab and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk)||||0.89
91533131|NCT02624778|182943429|SUPERIORITY||LS Mean|-0.205|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.41|0.0|||Mixed Models Analysis|||||0.00|-0.41|0.053
91509859|NCT00378703|182891867|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm C (bevacizumab and sorafenib) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.54
91509860|NCT00378703|182891867|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm D (sorafenib and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.68
91509861|NCT00378703|182891870|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0076
91509862|NCT00378703|182891870|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0085
91509863|NCT00378703|182891870|SUPERIORITY_OR_OTHER|||||||0.3006|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.3006
91509864|NCT03181542|182891898|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
91509865|NCT03181542|182891899|SUPERIORITY|||||||0.4|||||||Jonckheere-Terpstra Test|||||||0.40
91509866|NCT03181542|182891900|SUPERIORITY|||||||0.9|||||||Jonckheere-Terpstra Test|||||||0.90
91513428|NCT04289753|182898563|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
91513429|NCT04289753|182898564|SUPERIORITY||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.7|1.0||||||||1.0|0.70|
91513430|NCT00366626|182898600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_DEVIATION|6.32||0.51|TWO_SIDED|95.0|-1.85|3.69|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by two medication (naltrexone vs placebo) design. The main hypothesis was that the effect of naltrexone (mean naltrexone drinking - placebo drinking) would be greater in the 40asp subjects than in the asn40asn subjects. Thus the null hypothesis there would be no gene by medication interaction. The mean difference above is then the difference in the size of the naltrexone effect in the two genotypes, equivalent to the interaction.||3.69|-1.85|0.51
91513431|NCT00366626|182898601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_DEVIATION|6.1||0.28|TWO_SIDED|95.0|-1.22|4.11|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by 2 medication (naltrexone vs. placebo)interaction analysis. The main hypothesis was that subjects who had 40asp OPRM1 allele would a greater naltrexone effect on drinking (Placebo - Naltrexxone) than the asn40asn subjects. Thus the null hypothesis was the gene by medication interaction.||4.11|-1.22|0.28
91513432|NCT01242527|182898611|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.68||||0.005|TWO_SIDED|95.0|-40.7|-2.89||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors|||-2.89|-40.70|0.005
91509867|NCT00247728|182891907|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.072||95.0|||||Chi-squared|||||||0.072
91509868|NCT00247728|182891907|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.298||95.0|||||Chi-squared|||||||0.298
91509869|NCT00247728|182891908|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.087||95.0|||||Mantel Haenszel|||||||0.087
91509870|NCT00247728|182891908|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.653||95.0|||||Mantel Haenszel|||||||0.653
91509871|NCT01462357|182891910|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.16|1.15||||||Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.15|-1.16|
91509872|NCT01462357|182891910|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.15|1.14||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.14|-1.15|
91533132|NCT02624778|182943429|SUPERIORITY||LS Mean|-0.255|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||||-0.13|-0.38|<0.001
91533133|NCT02624778|182943429|SUPERIORITY||LS Mean|-0.369|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.23|||Mixed Models Analysis|||||-0.23|-0.51|<0.001
91533134|NCT02624778|182943429|SUPERIORITY||LS Mean|-0.329|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.20|-0.46|<0.001
91533135|NCT05541497|182943436|SUPERIORITY||Risk Ratio (RR)|1.51|||||TWO_SIDED|95.0|0.68|3.37||||||||3.37|0.68|
91509873|NCT01462357|182891911|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||ANOVA|||Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.69|0.54|
91509874|NCT01462357|182891911|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26|||ANOVA|||Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.26|0.20|
91509875|NCT01462357|182891912|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.|GMT ratio|4.52||||0.0001|TWO_SIDED|95.0|3.97|5.13|||ANOVA|||Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||5.13|3.97|0.0001
91533136|NCT05541497|182943437|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.59|3.13||||||||3.13|0.59|
91533137|NCT04091672|182943438|NON_INFERIORITY|"The one-sided 97.5% confidence interval (97.5% CI) was calculated for the difference (Control-RECELL) in percentages of subjects with confirmed treatment area closure.~The calculation used the normal approximation taking correlation into account. In order for the null hypothesis to be rejected and the non-inferiority of RECELL to be established, the upper limit of the 97.5% CI had to be less than 10%."||||||0.005|||||||1-sided z-test of proportions|alpha=0.025||||||.005
91533138|NCT04091672|182943439|SUPERIORITY|A geometric mean ratio (GMR of ratios) 95% CI with a lower bound exceeding 1 would indicate superiority of RECELL over Control with respect to this endpoint.||||||0.001|||||||GMR of ratios|||||||0.001
91533139|NCT01796665|182943445|EQUIVALENCE|provides 85% power of success|Equivalence ratio|96.57|||||TWO_SIDED|90.0|92.5|105.2|||Fieller's method|||||105.2|92.5|
91533140|NCT01796665|182943446|EQUIVALENCE|provides 85% power of success|Equivalence ratio|99.96|||||TWO_SIDED|90.0|92.9|110.5|||Fieller's method|||||110.5|92.9|
91533141|NCT01796665|182943447|EQUIVALENCE|provides 85% power of success|Equivalence ratio|-1.14|||||TWO_SIDED|90.0|-13.23|-1.13|||Fieller's method|||||-1.13|-13.23|
91509876|NCT01462357|182891912|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.|GMT ratio|1.69||||0.0001|TWO_SIDED|95.0|1.49|1.91|||ANOVA|||Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||1.91|1.49|0.0001
91509877|NCT04292730|182891943|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0174|TWO_SIDED|95.0|1.092|2.483||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||2.483|1.092|0.0174
91509878|NCT04292730|182891943|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1826|TWO_SIDED|95.0|0.88|1.952||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||1.952|0.880|0.1826
91509879|NCT04292730|182891943|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0168|TWO_SIDED|95.0|1.095|2.497||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||2.497|1.095|0.0168
91509880|NCT04292730|182891943|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2186|TWO_SIDED|95.0|0.862|1.917||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||1.917|0.862|0.2186
91509881|NCT04292730|182891944|SUPERIORITY||Difference in the Percentages|4.8||||0.3633|TWO_SIDED|95.0|-5.2|14.7||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||14.7|-5.2|0.3633
91509882|NCT04292730|182891944|SUPERIORITY||Difference in the Percentages|12.0||||0.0201|TWO_SIDED|95.0|1.6|21.8||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||21.8|1.6|0.0201
91509883|NCT00556842|182891975|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-6.37|||||TWO_SIDED|99.0|-9.18|-3.56||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC total at 24 months.||-3.56|-9.18|
91509884|NCT00556842|182891975|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.93|||||TWO_SIDED|99.0|-1.42|-0.44||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC pain at 24 months.||-0.44|-1.42|
91509885|NCT00556842|182891975|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.44|||||TWO_SIDED|99.0|-0.65|-0.23||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC stiffness at 24 months.||-0.23|-0.65|
91509886|NCT00556842|182891975|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-4.97|||||TWO_SIDED|99.0|-7.11|-2.83||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC function at 24 months.||-2.83|-7.11|
91509887|NCT00556842|182891976|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Odds Ratio (OR)|0.72|||||TWO_SIDED|99.0|0.38|1.36||||||Using a multi-level model, the effect of THA versus HA on mobility (TUG) was estimated. We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require \>12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. The TUG was summarized using odds ratios and 99% CIs.||1.36|0.38|
91509888|NCT00556842|182891977|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.41|||||TWO_SIDED|99.0|-0.33|3.14||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 PCS at 24 months.||3.14|-0.33|
91509889|NCT00556842|182891977|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|99.0|-0.38|3.05||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 MCS at 24 months.||3.05|-0.38|
91509890|NCT00556842|182891978|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|99.0|-0.03|0.11||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D utility index at 24 months.||0.11|-0.03|
91509891|NCT00556842|182891978|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.72|||||TWO_SIDED|99.0|-2.02|3.46||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D VAS at 24 months.||3.46|-2.02|
91509892|NCT01032135|182891980|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
91509893|NCT01032135|182891981|OTHER|||||||0.02|||||||Chi-squared|||||||0.02
91509894|NCT01032135|182891982|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
91509895|NCT01032135|182891987|OTHER||Odds Ratio (OR)|0.4||||0.0007|TWO_SIDED|95.0|0.23|0.68|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.68|0.23|0.0007
91509896|NCT01032135|182891987|OTHER||Odds Ratio (OR)|0.54||||0.16|TWO_SIDED|95.0|0.23|1.27|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.27|0.23|0.16
91509897|NCT01032135|182891987|OTHER||Odds Ratio (OR)|1.12||||0.79|TWO_SIDED|95.0|0.48|2.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.60|0.48|0.79
91509898|NCT01032135|182891992|OTHER||Odds Ratio (OR)|-1.08||||0.009|TWO_SIDED|95.0|-1.87|-0.29|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.29|-1.87|0.009
91509899|NCT01032135|182891992|OTHER||Odds Ratio (OR)|-0.84||||0.23|TWO_SIDED|95.0|-2.2|0.52|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.52|-2.20|0.23
91509900|NCT01032135|182891992|OTHER||Odds Ratio (OR)|-0.34||||0.58|TWO_SIDED|95.0|-1.52|0.85|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.85|-1.52|0.58
91509901|NCT01032135|182891997|OTHER||Odds Ratio (OR)|0.33||||0.0001|TWO_SIDED|95.0|0.19|0.58|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.58|0.19|0.0001
91509902|NCT01032135|182891997|OTHER||Odds Ratio (OR)|0.67||||0.36|TWO_SIDED|95.0|0.29|1.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.54|0.29|0.36
91509903|NCT01032135|182891997|OTHER||Odds Ratio (OR)|1.43||||0.45|TWO_SIDED|95.0|0.58|3.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.54|0.58|0.45
91509904|NCT01032135|182892002|OTHER||Odds Ratio (OR)|-1.09||||0.003|TWO_SIDED|95.0|-1.8|-0.39|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.39|-1.80|0.003
91509905|NCT01032135|182892002|OTHER||Odds Ratio (OR)|0.02||||0.1|TWO_SIDED|95.0|-1.1|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|-1.10|0.10
91533142|NCT01955382|182943448|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91755810|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||41.38|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|41.38
91509906|NCT01032135|182892006|OTHER||Odds Ratio (OR)|0.66||||0.13|TWO_SIDED|95.0|0.38|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|0.38|0.13
91509907|NCT01032135|182892006|OTHER||Odds Ratio (OR)|0.83||||0.71|TWO_SIDED|95.0|0.33|2.12|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.12|0.33|0.71
91509908|NCT01032135|182892006|OTHER||Odds Ratio (OR)|1.48||||0.36|TWO_SIDED|95.0|0.64|3.4|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.40|0.64|0.36
91755811|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.88|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|24.88
91509909|NCT01032135|182892009|OTHER||Odds Ratio (OR)|-0.13||||0.75|TWO_SIDED|95.0|-0.94|0.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.60|-0.94|0.75
91509910|NCT01032135|182892009|OTHER||Odds Ratio (OR)|-0.84||||0.16|TWO_SIDED|95.0|-1.98|0.3|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.30|-1.98|0.16
91509911|NCT01032135|182892009|OTHER||Odds Ratio (OR)|0.6||||0.42|TWO_SIDED|95.0|-0.85|2.04|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.04|-0.85|0.42
91509912|NCT03400033|182892010|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95 percent (%) confidence interval (CI) for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.05|||||TWO_SIDED|95.0|-0.21|0.1||||||||0.10|-0.21|
91509913|NCT03400033|182892011|SUPERIORITY||LS mean difference|-8.12||||0.3354|TWO_SIDED|95.0|-45.66|29.41|||ANCOVA|||||29.41|-45.66|0.3354
91509914|NCT03400033|182892012|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|-0.14|||||TWO_SIDED|95.0|-0.37|0.1||||||||0.10|-0.37|
91509915|NCT03400033|182892013|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was above the non-inferiority margin of - 15%.|Median Difference (Final Values)|11.18||||0.0034|TWO_SIDED|95.0|2.83|19.56|||Van Elteren's test||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||19.56|2.83|0.0034
91509916|NCT03400033|182892014|OTHER||Difference in response rate|0.1645||||0.0007|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.06|0.0007
91509917|NCT03400033|182892015|OTHER||Hazard Ratio (HR)|1.06||||0.5308|TWO_SIDED|95.0|0.26|4.22|||Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||4.22|0.26|0.5308
91509918|NCT03400033|182892016|SUPERIORITY||LS mean difference|-3.73||||0.083|TWO_SIDED|95.0|-9.03|1.56|||MMRM||SBP|||1.56|-9.03|0.083
91509919|NCT03400033|182892016|SUPERIORITY||LS mean difference|-2.23||||0.057|TWO_SIDED|95.0|-4.99|0.54|||MMRM||DBP|||0.54|-4.99|0.057
91533143|NCT02373813|182943477|SUPERIORITY||Risk Difference (RD)|20.8|STANDARD_ERROR_OF_MEAN|6.7||0.004|TWO_SIDED|95.0|7.6|33.9||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||33.9|7.6|0.004
91533144|NCT02373813|182943478|SUPERIORITY||Risk Difference (RD)|24.2|STANDARD_ERROR_OF_MEAN|8.3||0.006|TWO_SIDED|95.0|7.9|40.5||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||40.5|7.9|0.006
91533145|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|95.0|-0.48|0.27|||two sample t-test|||Baseline||0.27|-0.48|0.58
91509920|NCT03400033|182892016|SUPERIORITY||LS mean difference|-2.6||||0.059|TWO_SIDED|95.0|-5.86|0.67|||MMRM||MAP|||0.67|-5.86|0.059
91509921|NCT03400033|182892017|SUPERIORITY||Mean Difference (Net)|-0.5||||0.407|TWO_SIDED|95.0|-4.73|3.72|||ANCOVA||SBP|||3.72|-4.73|0.407
91509922|NCT03400033|182892017|SUPERIORITY||Mean Difference (Net)|-1.05||||0.179|TWO_SIDED|95.0|-3.29|1.19|||ANCOVA||DBP|||1.19|-3.29|0.179
91509923|NCT03400033|182892017|SUPERIORITY||Mean Difference (Net)|-0.86||||0.261|TWO_SIDED|95.0|-3.5|1.78|||ANCOVA||MAP|||1.78|-3.50|0.261
91509924|NCT03400033|182892018|OTHER||Ratio of exacerbation rate|0.7||||0.0093|TWO_SIDED|95.0|0.52|0.94|||Negative binomial model|||||0.94|0.52|0.0093
91755812|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.89|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|29.89
91755813|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||7.13|TWO_SIDED|95.0|0.87|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.87|7.13
91509925|NCT03400033|182892020|SUPERIORITY||LS mean difference|-0.15||||0.0323|TWO_SIDED|95.0|-0.32|0.01|||MMRM||Week 8|||0.01|-0.32|0.0323
91509926|NCT03400033|182892020|SUPERIORITY||LS mean difference|-0.12||||0.0921|TWO_SIDED|95.0|-0.29|0.06|||MMRM||Week 12|||0.06|-0.29|0.0921
91755814|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.91|TWO_SIDED|95.0|0.9|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.90|32.91
91509927|NCT03400033|182892020|SUPERIORITY||LS mean difference|-0.11||||0.1291|TWO_SIDED|95.0|-0.29|0.08|||MMRM||Week 28|||0.08|-0.29|0.1291
91509928|NCT03400033|182892020|SUPERIORITY||LS mean difference|-0.15||||0.0859|TWO_SIDED|95.0|-0.36|0.06|||MMRM||Week 52|||0.06|-0.36|0.0859
91509929|NCT01868633|182892033|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91509930|NCT02457325|182892055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
91509931|NCT02457325|182892056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.457|||||||t-test, 2 sided|||||||0.457
91509932|NCT02457325|182892057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
91509933|NCT02457325|182892058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.953|||||||t-test, 2 sided|||||||0.953
91509934|NCT02457325|182892059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||t-test, 2 sided|||||||0.693
91509935|NCT02457325|182892060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
91509936|NCT02457325|182892061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
91509937|NCT02457325|182892062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512|||||||t-test, 2 sided|||||||0.512
91509938|NCT02457325|182892063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.115|||||||t-test, 2 sided|||||||0.115
91509939|NCT02457325|182892064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||t-test, 2 sided|||||||0.730
91509940|NCT02457325|182892065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.835|||||||t-test, 2 sided|||||||0.835
91509941|NCT03385239|182892085|SUPERIORITY||Mean Difference in % CFB|-27.0||||0.0042|TWO_SIDED|95.0|-41.0|-10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-10|-41|0.0042
91509942|NCT03385239|182892085|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-48.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-48|-66|<0.0001
91509943|NCT03385239|182892085|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-70.0|-54.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-70|<0.0001
91509944|NCT03385239|182892085|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-53|-69|<0.0001
91509945|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0123|TWO_SIDED|95.0|-47.0|-8.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoC III||-8|-47|0.0123
91509946|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-76.0|-58.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-58|-76|<0.0001
91509947|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-65.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-65|-80|<0.0001
91509948|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-66.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-66|-80|<0.0001
91509949|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.568|TWO_SIDED|95.0|-11.0|7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||7|-11|0.568
91509950|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.008|TWO_SIDED|95.0|-19.0|-3.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-3|-19|0.008
91533146|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.85|TWO_SIDED|95.0|-0.37|0.31|||two sample t-test|||Baseline||0.31|-0.37|0.85
91509951|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4476|TWO_SIDED|95.0|-12.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||6|-12|0.4476
91509952|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.0606|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||0|-16|0.0606
91509953|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|7.0||||0.4509|TWO_SIDED|95.0|-10.0|26.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||26|-10|0.4509
91509954|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|4.0||||0.6746|TWO_SIDED|95.0|-12.0|23.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||23|-12|0.6746
91533147|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-2.61|STANDARD_ERROR_OF_MEAN|1.66||0.12|TWO_SIDED|95.0|-5.89|0.67|||two sample t-test|||Week 12||0.67|-5.89|0.12
91533148|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-2.64|STANDARD_ERROR_OF_MEAN|1.26||0.037|TWO_SIDED|95.0|-5.12|-0.16|||two sample t-test|||Week 12||-0.16|-5.12|0.037
91533149|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-2.33|STANDARD_ERROR_OF_MEAN|1.46||0.063|TWO_SIDED|95.0|-4.8|0.13|||two sample t-test|||Week 24||0.13|-4.80|0.063
91755815|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.15|TWO_SIDED|95.0|0.96|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.96|81.15
91509955|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|29.0||||0.0032|TWO_SIDED|95.0|9.0|53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||53|9|0.0032
91509956|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|12.0||||0.1996|TWO_SIDED|95.0|-6.0|32.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||32|-6|0.1996
91509957|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|12.0||||0.0373|TWO_SIDED|95.0|1.0|24.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||24|1|0.0373
91509958|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|34.0|||<|0.0001|TWO_SIDED|95.0|21.0|49.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||49|21|<0.0001
91509959|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|42.0|||<|0.0001|TWO_SIDED|95.0|28.0|57.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||57|28|<0.0001
91509960|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|30.0|||<|0.0001|TWO_SIDED|95.0|18.0|44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||44|18|<0.0001
91509961|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2826|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||6|-18|0.2826
91509962|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-34.0|-14.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-14|-34|<0.0001
91509963|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-15.0||||0.0118|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-4|-26|0.0118
91509964|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-20.0||||0.0009|TWO_SIDED|95.0|-29.0|-9.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-29|0.0009
91509965|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.0086|TWO_SIDED|95.0|-34.0|-6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-6|-34|0.0086
91509966|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-53.0|||<|0.0001|TWO_SIDED|95.0|-60.0|-44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-44|-60|<0.0001
91509967|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-50.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-50|-64|<0.0001
91509968|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-60.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-52.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-52|-66|<0.0001
91509969|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|2.0||||0.6801|TWO_SIDED|95.0|-7.0|13.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||13|-7|0.6801
91509970|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0007|TWO_SIDED|95.0|-24.0|-7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-7|-24|0.0007
91509971|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.3183|TWO_SIDED|95.0|-14.0|5.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-14|0.3183
91509972|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.024|TWO_SIDED|95.0|-19.0|-1.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-1|-19|0.024
91509973|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|5.0||||0.0936|TWO_SIDED|95.0|-1.0|11.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||11|-1|0.0936
91533150|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.34||0.64|TWO_SIDED|95.0|-3.27|2.01|||two sample t-test|||Week 24||2.01|-3.27|0.64
91509974|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|8.0|21.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||21|8|<0.0001
91509975|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|18.0|||<|0.0001|TWO_SIDED|95.0|11.0|25.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||25|11|<0.0001
91509976|NCT03385239|182892087|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|7.0|20.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||20|7|<0.0001
91509977|NCT03385239|182892088|SUPERIORITY||Odds Ratio (OR)|3.34||||0.2591|TWO_SIDED|95.0|0.41|27.2|||Regression, Logistic|||||27.20|0.41|0.2591
91533151|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.9||0.031|TWO_SIDED|95.0|-3.09|-0.15|||two sample t-test|||Week 36||-0.15|-3.09|0.031
91533152|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-1.77|STANDARD_ERROR_OF_MEAN|0.71||0.015|TWO_SIDED|95.0|-3.2|-0.35|||two sample t-test|||Week 36||-0.35|-3.20|0.015
91509978|NCT03385239|182892088|SUPERIORITY||Odds Ratio (OR)|84.02|||<|0.0001|TWO_SIDED|95.0|9.54|740.02|||Regression, Logistic|||||740.02|9.54|<0.0001
91509979|NCT03385239|182892088|SUPERIORITY||Odds Ratio (OR)|322.79|||<|0.0001|TWO_SIDED|95.0|20.31|5130.99|||Regression, Logistic|||||5130.99|20.31|<0.0001
91509980|NCT03385239|182892088|SUPERIORITY||Odds Ratio (OR)|342.13|||<|0.0001|TWO_SIDED|95.0|23.72|4933.89|||Regression, Logistic|||||4933.89|23.72|<0.0001
91509981|NCT03385239|182892089|SUPERIORITY||Odds Ratio (OR)|1.25||||0.9119|TWO_SIDED|95.0|0.02|69.88|||Regression, Logistic|||||69.88|0.02|0.9119
91509982|NCT03385239|182892089|SUPERIORITY||Odds Ratio (OR)|27.18||||0.0306|TWO_SIDED|95.0|1.36|542.48|||Regression, Logistic|||||542.48|1.36|0.0306
91509983|NCT03385239|182892089|SUPERIORITY||Odds Ratio (OR)|25.54||||0.0344|TWO_SIDED|95.0|1.27|514.2|||Regression, Logistic|||||514.20|1.27|0.0344
91509984|NCT03385239|182892089|SUPERIORITY||Odds Ratio (OR)|44.47||||0.0123|TWO_SIDED|95.0|2.28|866.49|||Regression, Logistic|||||866.49|2.28|0.0123
91509985|NCT01574703|182892093|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.37
91509986|NCT01574703|182892094|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.53
91509987|NCT01574703|182892095|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.34
91509988|NCT01574703|182892096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.49||||0.8375|TWO_SIDED|95.0|-5.22|4.23||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.23|-5.22|0.8375
91509989|NCT01574703|182892096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.978|TWO_SIDED|95.0|-5.2|5.05||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||5.05|-5.20|0.9780
91533153|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.87||0.58|TWO_SIDED|95.0|-2.55|1.45|||two sample t-test|||Week 48||1.45|-2.55|0.58
91509990|NCT01574703|182892096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.13||||0.6142|TWO_SIDED|95.0|-5.54|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.27|-5.54|0.6142
91509991|NCT01574703|182892096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.42||||0.8602|TWO_SIDED|95.0|-4.28|5.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||5.13|-4.28|0.8602
91509992|NCT01574703|182892096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.64||||0.7217|TWO_SIDED|95.0|-4.15|2.88||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.88|-4.15|0.7217
91509993|NCT01574703|182892096|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.06||||0.6322|TWO_SIDED|95.0|-5.41|3.28||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.28|-5.41|0.6322
91509994|NCT01574703|182892097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.9687|TWO_SIDED|95.0|-3.48|3.34||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||3.34|-3.48|0.9687
91509995|NCT01574703|182892097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.56||||0.7905|TWO_SIDED|95.0|-3.58|4.7||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||4.70|-3.58|0.7905
91509996|NCT01574703|182892097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8962|TWO_SIDED|95.0|-3.36|2.94||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.94|-3.36|0.8962
91509997|NCT01574703|182892097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.63||||0.7767|TWO_SIDED|95.0|-3.72|4.98||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||4.98|-3.72|0.7767
91509998|NCT01574703|182892097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.926|TWO_SIDED|95.0|-3.13|2.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.85|-3.13|0.9260
91509999|NCT01574703|182892097|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77||||0.7113|TWO_SIDED|95.0|-4.85|3.31||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.31|-4.85|0.7113
91533154|NCT02373813|182943479|SUPERIORITY||Treatment Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.45||0.02|TWO_SIDED|95.0|-1.99|-0.17|||two sample t-test|||Week 48||-0.17|-1.99|0.020
91533155|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED|95.0|-5.68|0.77|||two sample t-test|||Change at Week 12||0.77|-5.68|0.13
91510000|NCT01574703|182892098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.8117|TWO_SIDED|95.0|-5.27|4.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.13|-5.27|0.8117
91510001|NCT01574703|182892098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.78||||0.7303|TWO_SIDED|95.0|-5.21|3.65||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.65|-5.21|0.7303
91510002|NCT01574703|182892098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.5946|TWO_SIDED|95.0|-5.6|3.21||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.21|-5.60|0.5946
91510003|NCT01574703|182892098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.92|TWO_SIDED|95.0|-4.27|3.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.85|-4.27|0.9200
91510004|NCT01574703|182892098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.62||||0.7236|TWO_SIDED|95.0|-4.09|2.84||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.84|-4.09|0.7236
91510005|NCT01574703|182892098|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.42||||0.8201|TWO_SIDED|95.0|-4.01|3.17||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.17|-4.01|0.8201
91510006|NCT01574703|182892099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8932|TWO_SIDED|95.0|-3.22|2.81||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.81|-3.22|0.8932
91510007|NCT01574703|182892099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.23||||0.8747|TWO_SIDED|95.0|-3.09|2.63||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.63|-3.09|0.8747
91510008|NCT01574703|182892099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.671|TWO_SIDED|95.0|-3.35|2.15||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.15|-3.35|0.6710
91510009|NCT01574703|182892099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9886|TWO_SIDED|95.0|-3.32|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.27|-3.32|0.9886
91533156|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.25||0.045|TWO_SIDED|95.0|-4.99|-0.06|||two sample t-test|||Change at Week 12||-0.06|-4.99|0.045
91755816|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||21.87|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|21.87
91755817|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.49|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|24.49
91510010|NCT01574703|182892099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39||||0.7631|TWO_SIDED|95.0|-2.92|2.14||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.14|-2.92|0.7631
91510011|NCT01574703|182892099|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.8022|TWO_SIDED|95.0|-3.23|2.5||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.50|-3.23|0.8022
91510012|NCT01574703|182892100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.91||||0.6441|TWO_SIDED|95.0|-4.78|2.96||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.96|-4.78|0.6441
91533157|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-2.27|STANDARD_ERROR_OF_MEAN|1.45||0.071|TWO_SIDED|95.0|-4.75|0.2|||two sample t-test|||Change at Week 24||0.20|-4.75|0.071
91533158|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-0.64|STANDARD_ERROR_OF_MEAN|1.34||0.63|TWO_SIDED|95.0|-3.28|2.0|||two sample t-test|||Change at Week 24||2.00|-3.28|0.63
91755818|NCT02294734|183404486|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||55.52|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|55.52
91755819|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||59.55|TWO_SIDED|95.0|0.84|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.84|59.55
91755820|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||94.01|TWO_SIDED|95.0|0.96|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.96|94.01
91755821|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||82.27|TWO_SIDED|95.0|0.9|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.90|82.27
91755822|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||99.22|TWO_SIDED|95.0|1.06|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|1.06|99.22
91755823|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||46.24|TWO_SIDED|95.0|0.75|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.75|46.24
91755824|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||98.3|TWO_SIDED|95.0|1.02|1.64||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.64|1.02|98.30
91755825|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||92.6|TWO_SIDED|95.0|0.92|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.92|92.60
91755826|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||99.01|TWO_SIDED|95.0|1.05|1.81||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.81|1.05|99.01
91755827|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||58.8|TWO_SIDED|95.0|0.82|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.82|58.80
91755828|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||86.82|TWO_SIDED|95.0|0.91|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.91|86.82
91510013|NCT01574703|182892100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.69||||0.7327|TWO_SIDED|95.0|-4.63|3.26||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.26|-4.63|0.7327
91533159|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.91||0.037|TWO_SIDED|95.0|-3.11|-0.1|||two sample t-test|||Change at Week 36||-0.10|-3.11|0.037
91533160|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|0.73||0.013|TWO_SIDED|95.0|-3.3|-0.39|||two sample t-test|||Change at Week 36||-0.39|-3.30|0.013
91755829|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.37|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|67.37
91510014|NCT01574703|182892100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.99||||0.6109|TWO_SIDED|95.0|-4.8|2.82||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.82|-4.80|0.6109
91533161|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.62|TWO_SIDED|95.0|-2.54|1.53|||two sample t-test|||Change at Week 48||1.53|-2.54|0.62
91533162|NCT02373813|182943480|SUPERIORITY||Treatment Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.45||0.015|TWO_SIDED|95.0|-2.02|-0.22|||two sample t-test|||Change at Week 48||-0.22|-2.02|0.015
91533163|NCT02373813|182943481|SUPERIORITY||Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.75|TWO_SIDED|95.0|-0.19|0.26|||two sample t-test|||Baseline||0.26|-0.19|0.75
91533164|NCT02373813|182943481|SUPERIORITY||Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED|95.0|-0.11|0.27|||two sample t-test|||Baseline||0.27|-0.11|0.43
91533165|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.91|0.0|||two sample t-test|||Week 12||0.00|-0.91|0.049
91533166|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.032|TWO_SIDED|95.0|-0.77|-0.04|||two sample t-test|||Week 12||-0.04|-0.77|0.032
91510015|NCT01574703|182892100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.8707|TWO_SIDED|95.0|-2.48|2.93||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.93|-2.48|0.8707
91755830|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||98.35|TWO_SIDED|95.0|1.01|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|1.01|98.35
91510016|NCT01574703|182892100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.9531|TWO_SIDED|95.0|-2.63|2.48||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.48|-2.63|0.9531
91510017|NCT01574703|182892100|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||0.8262|TWO_SIDED|95.0|-2.99|2.39||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.39|-2.99|0.8262
91510018|NCT01574703|182892101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.59||||0.6105|TWO_SIDED|95.0|-2.84|1.67||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||1.67|-2.84|0.6105
91510019|NCT01574703|182892101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.32||||0.7895|TWO_SIDED|95.0|-2.65|2.01||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.01|-2.65|0.7895
91510020|NCT01574703|182892101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.48||||0.6804|TWO_SIDED|95.0|-2.75|1.8||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||1.80|-2.75|0.6804
91510021|NCT01574703|182892101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.27||||0.8127|TWO_SIDED|95.0|-1.95|2.49||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.49|-1.95|0.8127
91510022|NCT01574703|182892101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||0.9218|TWO_SIDED|95.0|-2.04|2.25||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.25|-2.04|0.9218
91510023|NCT01574703|182892101|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16||||0.8841|TWO_SIDED|95.0|-2.32|2.0||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.00|-2.32|0.8841
91510024|NCT00749931|182892102|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91510025|NCT00749931|182892103|SUPERIORITY_OR_OTHER||Relative reduction|0.47||||0.002|||||||Fisher Exact|||||||0.002
91510026|NCT03890367|182892157|NON_INFERIORITY|The two-sided 97.5 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.2|5.68|
91510027|NCT03890367|182892158|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
91510028|NCT03890367|182892159|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
91510029|NCT03890367|182892160|SUPERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The superiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>0%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.20|5.68|
91510030|NCT03890367|182892161|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.3|2.28||||||||2.28|-2.30|
91510031|NCT03890367|182892162|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
91510032|NCT03890367|182892163|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
91755831|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||96.86|TWO_SIDED|95.0|0.99|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.99|96.86
91755832|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||86.18|TWO_SIDED|95.0|0.95|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.95|86.18
91755833|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||98.89|TWO_SIDED|95.0|1.02|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|1.02|98.89
91755834|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||91.94|TWO_SIDED|95.0|0.97|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.97|91.94
91759846|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.76|2.62||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-1.76|
91510033|NCT03890367|182892164|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|5.24|||||TWO_SIDED|97.5|1.83|9.85||||||||9.85|1.83|
91510034|NCT03890367|182892165|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
91510035|NCT03890367|182892166|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
91510036|NCT03890367|182892167|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.71|2.67||||||||2.67|-2.71|
91510037|NCT03890367|182892168|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
91510038|NCT03890367|182892169|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
91510039|NCT02556710|182892170|SUPERIORITY|||||||0.94|||||||ANCOVA|Adjusted for baseline WOMAC Score||||||0.94
91510040|NCT02556710|182892171|SUPERIORITY|||||||0.53|||||||ANCOVA|Adjusted for baseline WOMAC score||||||0.53
91510041|NCT02556710|182892172|SUPERIORITY|||||||0.35||||||Adjusted for baseline WOMAC Score.|ANCOVA|||||||0.35
91510042|NCT04524403|182892178|SUPERIORITY||Least Squares Mean Difference|0.24||||0.787|TWO_SIDED|95.0|-1.52|2.01|||Mixed Models Analysis|||||2.01|-1.52|0.7870
91510043|NCT04524403|182892178|SUPERIORITY||Least Squares Mean Difference|0.75||||0.4018|TWO_SIDED|95.0|-1.01|2.51|||Mixed Models Analysis|||||2.51|-1.01|0.4018
91510044|NCT04524403|182892179|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5228|TWO_SIDED|95.0|-1.03|2.02|||Mixed Models Analysis|||||2.02|-1.03|0.5228
91510045|NCT04524403|182892180|SUPERIORITY||Odds Ratio (OR)|1.781||||0.2537|TWO_SIDED|95.0|0.661|4.802|||Regression, Logistic|||||4.802|0.661|0.2537
91510046|NCT04524403|182892180|SUPERIORITY||Odds Ratio (OR)|0.916||||0.874|TWO_SIDED|95.0|0.308|2.722|||Regression, Logistic|||||2.722|0.308|0.8740
91510047|NCT04524403|182892181|SUPERIORITY||Least Squares Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.021|0.021|||Mixed Models Analysis|||||0.021|-0.021|0.9870
91510048|NCT04524403|182892181|SUPERIORITY||Least Squares Mean Difference|0.008||||0.4624|TWO_SIDED|95.0|-0.013|0.029|||Mixed Models Analysis|||||0.029|-0.013|0.4624
91510049|NCT00991302|182892185|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|stratified by dosing complexity||"Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.~The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID."||||0.52
91510050|NCT01709318|182892193|NON_INFERIORITY|Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|8.3|||||TWO_SIDED|95.0|-4.3|26.5|||||95% CI adjusted for multiplicity (Dunnett)|||26.5|-4.3|
91755835|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.32|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.32
91755836|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||97.17|TWO_SIDED|95.0|1.0|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|1.00|97.17
91755837|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||96.57|TWO_SIDED|95.0|0.99|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.99|96.57
91755838|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||79.13|TWO_SIDED|95.0|0.9|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.90|79.13
91755839|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||99.54|TWO_SIDED|95.0|1.05|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|1.05|99.54
91755840|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||97.8|TWO_SIDED|95.0|1.0|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|1.00|97.80
91755841|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||71.94|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|71.94
91755842|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||85.3|TWO_SIDED|95.0|0.94|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.94|85.30
91755843|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||82.15|TWO_SIDED|95.0|0.94|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.94|82.15
91755844|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||72.55|TWO_SIDED|95.0|0.88|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.88|72.55
91533167|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.18|TWO_SIDED|95.0|-0.58|0.11|||two sample t-test|||Week 24||0.11|-0.58|0.18
91759847|NCT01393639|183411982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.63|2.74||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.74|-1.63|
91510051|NCT01709318|182892193|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.7|24.8|||||95% CI adjusted for multiplicity (Dunnett)|||24.8|-5.7|
91510052|NCT01709318|182892193|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|12.3|||||TWO_SIDED|95.0|-1.7|33.1|||||95% CI adjusted for multiplicity (Dunnett)|||33.1|-1.7|
91510053|NCT01709318|182892193|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.6|||||TWO_SIDED|95.0|-5.7|25.4|||||95% CI adjusted for multiplicity (Dunnett)|||25.4|-5.7|
91510054|NCT01709318|182892193|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|9.3|||||TWO_SIDED|95.0|-3.5|27.4|||||95% CI adjusted for multiplicity (Dunnett)|||27.4|-3.5|
91510055|NCT01709318|182892193|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-10.7|15.9|||||95% CI adjusted for multiplicity (Dunnett)|||15.9|-10.7|
91510056|NCT01709318|182892194|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.2|||||TWO_SIDED|95.0|-3.6|16.4|||||95% CI adjusted for multiplicity (Dunnett)|||16.4|-3.6|
91510057|NCT01709318|182892194|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
91510058|NCT01709318|182892194|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.0|||||TWO_SIDED|95.0|-3.8|17.5|||||95% CI adjusted for multiplicity (Dunnett)|||17.5|-3.8|
91510059|NCT01709318|182892194|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|4.7|||||TWO_SIDED|95.0|-2.5|18.9|||||95% CI adjusted for multiplicity (Dunnett)|||18.9|-2.5|
91510060|NCT01709318|182892194|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|1.4|||||TWO_SIDED|95.0|-5.0|13.4|||||95% CI adjusted for multiplicity (Dunnett)|||13.4|-5.0|
91510061|NCT01709318|182892194|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
91510062|NCT01709318|182892195|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.08||||0.096|||||||LDA|||||||0.096
91510063|NCT01709318|182892195|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.993|||||||LDA|||||||0.993
91510064|NCT01709318|182892195|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.08||||0.124|||||||LDA|||||||0.124
91510065|NCT01709318|182892195|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.05||||0.845|||||||LDA|||||||0.845
91510066|NCT01709318|182892195|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||0.976|||||||LDA|||||||0.976
91510067|NCT01709318|182892195|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.995|||||||LDA|||||||0.995
91510068|NCT01709318|182892196|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.01||||1|||||||LDA|||||||1.000
91533168|NCT02373813|182943481|SUPERIORITY||Treatment Difference|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED|95.0|-0.24|0.51|||two sample t-test|||Week 24||0.51|-0.24|0.48
91755845|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||98.44|TWO_SIDED|95.0|1.02|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|1.02|98.44
91755846|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||78.24|TWO_SIDED|95.0|0.86|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.86|78.24
91755847|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||96.8|TWO_SIDED|95.0|0.99|1.52||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.52|0.99|96.80
91533169|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.35|TWO_SIDED|95.0|-0.51|0.18|||two sample t-test|||Week 36||0.18|-0.51|0.35
91533170|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.41|0.12|||two sample t-test|||Week 36||0.12|-0.41|0.28
91533171|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.48|TWO_SIDED|95.0|-0.44|0.21|||two sample t-test|||Week 48||0.21|-0.44|0.48
91533172|NCT02373813|182943481|SUPERIORITY||Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.92|TWO_SIDED|95.0|-0.26|0.24|||two sample t-test|||Week 48||0.24|-0.26|0.92
91533173|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.91|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.91|0.032
91533174|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED|95.0|-0.78|-0.15|||two sample t-test|||Change at Week 12||-0.15|-0.78|0.005
91533175|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.058|TWO_SIDED|95.0|-0.63|0.01|||two sample t-test|||Change at Week 24||0.01|-0.63|0.058
91533176|NCT02373813|182943482|SUPERIORITY||Treatment Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||two sample t-test|||Change at Week 24||0.38|-0.29|0.78
91533177|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.27|TWO_SIDED|95.0|-0.49|0.14|||two sample t-test|||Change at Week 36||0.14|-0.49|0.27
91533178|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.078|TWO_SIDED|95.0|-0.47|0.03|||two sample t-test|||Change at Week 36||0.03|-0.47|0.078
91533179|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.47|TWO_SIDED|95.0|-0.43|0.2|||two sample t-test|||Week 48||0.20|-0.43|0.47
91533180|NCT02373813|182943482|SUPERIORITY||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.39|TWO_SIDED|95.0|-0.33|0.13|||two sample t-test|||Change at Week 48||0.13|-0.33|0.39
91533181|NCT02373813|182943483|SUPERIORITY||Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6|TWO_SIDED|95.0|-0.09|0.15|||two sample t-test|||Baseline||0.15|-0.09|0.60
91533182|NCT02373813|182943483|SUPERIORITY||Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED|95.0|-0.1|0.1|||two sample t-test|||Baseline||0.10|-0.10|0.97
91533183|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.044|TWO_SIDED|95.0|-0.82|-0.01|||two sample t-test|||Week 12||-0.01|-0.82|0.044
91533184|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.76|-0.14|||two sample t-test|||Week 12||-0.14|-0.76|0.004
91533185|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.009|TWO_SIDED|95.0|-0.66|-0.1|||two sample t-test|||Week 24||-0.10|-0.66|0.009
91533186|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Week 24||0.16|-0.46|0.34
91533187|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.046|TWO_SIDED|95.0|-0.47|0.0|||two sample t-test|||Week 36||0.00|-0.47|0.046
91533188|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.49|-0.08|||two sample t-test|||Week 36||-0.08|-0.49|0.006
91533189|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.25|TWO_SIDED|95.0|-0.4|-0.1|||two sample t-test|||Week 48||-0.10|-0.40|0.25
91533190|NCT02373813|182943483|SUPERIORITY||Treatment Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.37|-0.03|||two sample t-test|||Week 48||-0.03|-0.37|0.021
91533191|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.82|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.82|0.030
91533192|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.005|TWO_SIDED|95.0|-0.72|-0.13|||two sample t-test|||Change at Week 12||-0.13|-0.72|0.005
91533193|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.69|-0.15|||two sample t-test|||Change at Week 24||-0.15|-0.69|0.002
91755848|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||91.11|TWO_SIDED|95.0|0.97|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.97|91.11
91510069|NCT01709318|182892196|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.19||||0.996|||||||LDA|||||||0.996
91510070|NCT01709318|182892196|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.06||||1|||||||LDA|||||||1.000
91533194|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Change at Week 24||0.16|-0.46|0.34
91510071|NCT01709318|182892196|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||1|||||||LDA|||||||1.000
91510072|NCT01709318|182892196|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.09||||1|||||||LDA|||||||1.000
91510073|NCT01709318|182892196|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.24||||0.998|||||||LDA|||||||0.998
91510074|NCT02139644|182892208|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.154||||0.0076|TWO_SIDED|95.0|0.041|0.267|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.267|0.041|0.0076
91510075|NCT02139644|182892208|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.131||||0.0322|TWO_SIDED|95.0|0.011|0.25|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.250|0.011|0.0322
91510076|NCT02139644|182892208|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.335||||0|TWO_SIDED|95.0|0.216|0.453|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.453|0.216|0.0000
91510077|NCT02139644|182892208|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.325||||0|TWO_SIDED|95.0|0.203|0.447|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.447|0.203|0.0000
91510078|NCT02139644|182892209|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.262||||0|TWO_SIDED|95.0|0.168|0.356|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.356|0.168|0.0000
91510079|NCT02139644|182892209|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.266||||0|TWO_SIDED|95.0|0.172|0.36|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.172|0.0000
91510080|NCT02139644|182892209|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.151||||0.0017|TWO_SIDED|95.0|0.057|0.244|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.244|0.057|0.0017
91510081|NCT02139644|182892209|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.119||||0.0132|TWO_SIDED|95.0|0.025|0.212|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.212|0.025|0.0132
91510082|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.926||||0.0123|TWO_SIDED|95.0|2.38|19.471||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.471|2.380|0.0123
91510083|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|7.018||||0.1074|TWO_SIDED|95.0|-1.531|15.567||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||15.567|-1.531|0.1074
91510084|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|20.824||||0|TWO_SIDED|95.0|12.253|29.395||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.395|12.253|0.0000
91510085|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.273||||0|TWO_SIDED|95.0|12.728|29.818||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.818|12.728|0.0000
91533195|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.014|TWO_SIDED|95.0|-0.52|-0.06|||two sample t-test|||Change at Week 36||-0.06|-0.52|0.014
91533196|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.51|-0.1|||two sample t-test|||Change at Week 36||-0.10|-0.51|0.004
91533197|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.43|0.05|||two sample t-test|||Change at Week 48||0.05|-0.43|0.12
91533198|NCT02373813|182943484|SUPERIORITY||Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.01|TWO_SIDED|95.0|-0.37|-0.05|||two sample t-test|||Change at Week 48||-0.05|-0.37|0.010
91533199|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|-0.62|0.02|||two sample t-test|||Baseline||0.02|-0.62|0.067
91533200|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.59|TWO_SIDED|95.0|-0.41|0.23|||two sample t-test|||Baseline||0.23|-0.41|0.59
91533201|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.62||0.13||95.0|-5.66|0.74|||two sample t-test|||Week 12||0.74|-5.66|0.13
91533202|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-2.34|STANDARD_ERROR_OF_MEAN|1.23||0.059|TWO_SIDED|95.0|-4.76|0.09|||two sample t-test|||Week 12||0.09|-4.76|0.059
91533203|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-2.72|STANDARD_ERROR_OF_MEAN|1.38||0.017|TWO_SIDED|95.0|-4.95|-0.5|||two sample t-test|||Week 24||-0.50|-4.95|0.017
91533204|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.32||0.74|TWO_SIDED|95.0|-3.04|2.15|||two sample t-test|||Week 24||2.15|-3.04|0.74
91533205|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-3.03|-0.08|||two sample t-test|||Week 36||-0.08|-3.03|0.039
91755849|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||89.3|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|89.30
91755850|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||74.67|TWO_SIDED|95.0|0.87|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.87|74.67
91533206|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.72||0.023|TWO_SIDED|95.0|-3.1|-0.23|||two sample t-test|||Week 36||-0.23|-3.10|0.023
91533207|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.85||0.65|TWO_SIDED|95.0|-2.43|1.52|||two sample t-test|||Week 48||1.52|-2.43|0.65
91533208|NCT02373813|182943485|SUPERIORITY||Treatment Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.44||0.017|TWO_SIDED|95.0|-1.94|-0.19|||two sample t-test|||Week 48||-0.19|-1.94|0.017
91533209|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-2.15|STANDARD_ERROR_OF_MEAN|1.59||0.18||95.0|-5.29|1.0|||two sample t-test|||Change at Week 12||1.00|-5.29|0.18
91533210|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.21||0.067|TWO_SIDED|95.0|-4.63|0.16|||two sample t-test|||Change at Week 12||0.16|-4.63|0.067
91533211|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.37||0.035|TWO_SIDED|95.0|-4.62|-0.17|||two sample t-test|||Change at Week 24||-0.17|-4.62|0.035
91533212|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.3||0.79|TWO_SIDED|95.0|-2.91|2.23|||two sample t-test|||Change at Week 24||2.23|-2.91|0.79
91533213|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.91||0.09|TWO_SIDED|95.0|-2.75|0.2|||two sample t-test|||Change at Week 36||0.20|-2.75|0.090
91533214|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.72||0.029|TWO_SIDED|95.0|-3.06|-0.17|||two sample t-test|||Change at Week 36||-0.17|-3.06|0.029
91533215|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.84||0.86|TWO_SIDED|95.0|-2.15|1.81|||two sample t-test|||Change at Week 48||1.81|-2.15|0.86
91533216|NCT02373813|182943486|SUPERIORITY||Treatment Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.43||0.021|TWO_SIDED|95.0|-1.88|-0.16|||two sample t-test|||Change at Week 48||-0.16|-1.88|0.021
91533217|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.4||1|TWO_SIDED|95.0|-6.5|6.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||6.6|-6.5|1.00
91533218|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|-3.9|STANDARD_ERROR_OF_MEAN|3.3||0.38|TWO_SIDED|95.0|-10.4|2.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||2.6|-10.4|0.38
91533219|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|24.5|STANDARD_ERROR_OF_MEAN|7.9||0.007|TWO_SIDED|95.0|9.0|40.0|||Chi-squared, Corrected|||Week 12||40.0|9.0|0.007
91533220|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|14.0|STANDARD_ERROR_OF_MEAN|6.9||0.063|TWO_SIDED|95.0|0.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||27.6|0.4|0.063
91755851|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||98.25|TWO_SIDED|95.0|1.02|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|1.02|98.25
91759848|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.49|||||TWO_SIDED|95.0|-12.52|3.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.55|-12.52|
91510086|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|9.898||||0.0233|TWO_SIDED|95.0|1.349|18.447||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.447|1.349|0.0233
91510087|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|14.255||||0.0011|TWO_SIDED|95.0|5.732|22.778||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||22.778|5.732|0.0011
91510088|NCT02139644|182892210|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.347||||0.0175|TWO_SIDED|95.0|1.822|18.872||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.872|1.822|0.0175
91510089|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.165||||0.0002|TWO_SIDED|95.0|-0.251|-0.08||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.080|-0.251|0.0002
91510090|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.143||||0.001|TWO_SIDED|95.0|-0.229|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.229|0.0010
91510091|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.23||||0|TWO_SIDED|95.0|-0.315|-0.144||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.144|-0.315|0.0000
91510092|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.194||||0|TWO_SIDED|95.0|-0.279|-0.109||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.109|-0.279|0.0000
91510093|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.064||||0.1381|TWO_SIDED|95.0|-0.15|0.021||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.021|-0.150|0.1381
91510094|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.051||||0.2438|TWO_SIDED|95.0|-0.136|0.035||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.035|-0.136|0.2438
91510095|NCT02139644|182892211|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.029||||0.5095|TWO_SIDED|95.0|-0.114|0.057||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.057|-0.114|0.5095
91533221|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|23.2|STANDARD_ERROR_OF_MEAN|8.4||0.012|TWO_SIDED|95.0|6.7|39.8|||Chi-squared, Corrected|||Week 24||39.8|6.7|0.012
91533222|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|17.8|STANDARD_ERROR_OF_MEAN|7.0||0.018|TWO_SIDED|95.0|4.1|31.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||31.5|4.1|0.018
91533223|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|19.0|STANDARD_ERROR_OF_MEAN|8.6||0.044|TWO_SIDED|95.0|2.1|35.9|||Chi-squared, Corrected|||Week 36||35.9|2.1|0.044
91533224|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|19.5|STANDARD_ERROR_OF_MEAN|7.0||0.01|TWO_SIDED|95.0|5.8|33.2|||Chi-squared, Corrected|||Week 36||33.2|5.8|0.010
91533225|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|25.7|STANDARD_ERROR_OF_MEAN|8.6||0.005|TWO_SIDED|95.0|8.9|42.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||42.5|8.9|0.005
91533226|NCT02373813|182943487|SUPERIORITY||Risk Difference (RD)|21.6|STANDARD_ERROR_OF_MEAN|7.0||0.004|TWO_SIDED|95.0|7.9|35.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||35.2|7.9|0.004
91533227|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|11.1|STANDARD_ERROR_OF_MEAN|8.4||0.25|TWO_SIDED|95.0|-5.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||27.6|-5.4|0.25
91533228|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|6.7||1|TWO_SIDED|95.0|-12.5|13.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||13.8|-12.5|1.00
91533229|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|1.6|STANDARD_ERROR_OF_MEAN|6.8||0.98|TWO_SIDED|95.0|-11.6|14.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||14.9|-11.6|0.98
91533230|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|5.0|STANDARD_ERROR_OF_MEAN|5.7||0.48|TWO_SIDED|95.0|-6.2|16.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||16.2|-6.2|0.48
91533231|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.16|TWO_SIDED|95.0|-3.1|25.7||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||25.7|-3.1|0.16
91533232|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|5.3||0.94|TWO_SIDED|95.0|-9.0|11.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||11.9|-9.0|0.94
91533233|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|7.4||0.12|TWO_SIDED|95.0|-2.1|27.0||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||27.0|-2.1|0.12
91755852|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.8|TWO_SIDED|95.0|0.96|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.96|87.80
91533234|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|5.6||0.4|TWO_SIDED|95.0|-5.2|16.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||16.8|-5.2|0.40
91533235|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.63|TWO_SIDED|95.0|-9.8|20.4||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||20.4|-9.8|0.63
91533236|NCT02373813|182943488|SUPERIORITY||Risk Difference (RD)|-6.9|STANDARD_ERROR_OF_MEAN|5.7||0.31|TWO_SIDED|95.0|-18.0|4.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||4.2|-18.0|0.31
91533237|NCT02373813|182943490|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
91533238|NCT02373813|182943490|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
91755853|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||91.54|TWO_SIDED|95.0|0.97|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.97|91.54
91533239|NCT02373813|182943491|SUPERIORITY|||||||0.31||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.31
91533240|NCT02373813|182943491|SUPERIORITY|||||||0.51||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.51
91533241|NCT02373813|182943492|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|14.1||0.58|TWO_SIDED|95.0|-15.2|40.2|||Chi-squared, Corrected|||||40.2|-15.2|0.58
91533242|NCT03929302|182943504|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
91533243|NCT03929302|182943504|SUPERIORITY||Mean Difference (Final Values)|1.57||||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
91533244|NCT03929302|182943504|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.642|TWO_SIDED||||||Regression, Linear|||||||0.642
91533245|NCT03815916|182943521|SUPERIORITY||Mean Difference (Final Values)|0.3865||||0.1077|TWO_SIDED||||||t-test, 2 sided|||The primary efficacy endpoint is the mean change in the average NAD+/NADH brain ratio from baseline to Week 12 using a partial volume coil 31P-MRS data on the Per Protocol Treatment Population. A paired t-test will be used to analyze the mean change from baseline.||||0.1077
91533246|NCT02688621|182943609|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||The study was designed to detect a 2.2-kg group weight loss difference between groups with a standard deviation of 5.8 kg,4,5 a 5% Type I error rate, and 80% power. To adjust for possible clustering effects in this nested design, the adjusted variance estimate was increased to 7.67, calculated using a conservative intraclass correlation coefficient of 0.05.||||<.01
91533247|NCT01996644|182943625|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
91533248|NCT05349864|182943634|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|120.25|||||TWO_SIDED|90.0|109.76|131.75||||||||131.75|109.76|
91533249|NCT05349864|182943635|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|116.22|||||TWO_SIDED|90.0|97.91|137.95||||||||137.95|97.91|
91533250|NCT05349864|182943636|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|206.91|||||TWO_SIDED|90.0|171.14|250.15||||||||250.15|171.14|
91533251|NCT05349864|182943637|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUClast was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|135.77|||||TWO_SIDED|90.0|114.36|161.19||||||||161.19|114.36|
91533252|NCT05349864|182943638|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUCinf was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|138.36|||||TWO_SIDED|90.0|106.11|180.41||||||||180.41|106.11|
91533253|NCT05349864|182943639|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed Cmax was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|236.58|||||TWO_SIDED|90.0|190.12|294.38||||||||294.38|190.12|
91533254|NCT00984282|182943648|SUPERIORITY_OR_OTHER||||||<|0.0001||||||stratified by age group (\< 60 years, \>= 60 years) and region (Europe, North-America, Asia)|Log Rank|||The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.||||<0.0001
91533255|NCT00984282|182943648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.454|0.758|||Regression, Cox|stratified by age group and region||||0.758|0.454|
91533256|NCT00984282|182943649|SUPERIORITY_OR_OTHER|||||||0.2892|||||||Log Rank|stratified by age group and region||||||0.2892
91533257|NCT00984282|182943649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928|||||TWO_SIDED|95.0|0.713|1.208|||Regression, Cox|stratified by age group and region||||1.208|0.713|
91533258|NCT00984282|182943650|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|stratified by age group and region||||||<0.0001
91533259|NCT00984282|182943650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.557|||||TWO_SIDED|95.0|0.429|0.724|||Regression, Cox|stratified by age group and region||||0.724|0.429|
91533260|NCT00984282|182943651|SUPERIORITY_OR_OTHER||Difference of response rates|11.7||||0.0015|TWO_SIDED|95.0|3.9|19.4||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||19.4|3.9|0.0015
91533261|NCT00984282|182943652|SUPERIORITY_OR_OTHER||Difference in response rate|11.8|||<|0.0001|TWO_SIDED|95.0|7.0|16.5||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||16.5|7.0|<0.0001
91759849|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.15|||||TWO_SIDED|95.0|-18.1|-2.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.20|-18.10|
91533262|NCT04541186|182943693|SUPERIORITY||Median Percent Change Difference|-43.73|||<|0.001|TWO_SIDED|95.0|-57.08|-30.31||Significant level = 0.05|van Elteren test|Nonparametric analysis stratified by baseline TG level and background lipid therapy to test the treatment difference using pooled data.|The location shift and Hodges-Lehmann 95% confidence interval were based on Hodges-Lehman estimation. Placebo group is the reference group, and the comparison was performed in pooled pegozafermin treatment group vs. placebo pooled.|||-30.31|-57.08|<0.001
91533263|NCT04541186|182943694|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline TG level and lipid modifying therapy use.||||||<0.001
91533264|NCT04541186|182943695|SUPERIORITY||Least Squares Means Difference|-17.87|STANDARD_ERROR_OF_MEAN|6.425||0.007|TWO_SIDED|95.0|-30.67|-5.07||Significant level = 0.05|MMRM|||MMRM analysis of non-HDL-C comparison between pegozafermin pooled versus placebo pooled group.||-5.07|-30.67|0.007
91533265|NCT04541186|182943695|SUPERIORITY||Least Squares Means Difference|-11.75|STANDARD_ERROR_OF_MEAN|4.888||0.019|TWO_SIDED|95.0|-21.48|-2.01||Significant level of 0.05|MMRM|||MMRM analysis of ApoB comparison between pegozafermin pooled versus placebo pooled group.||-2.01|-21.48|0.019
91510096|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.463||||0.0004|TWO_SIDED|95.0|-0.716|-0.209||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.209|-0.716|0.0004
91510097|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.464||||0.0003|TWO_SIDED|95.0|-0.718|-0.211||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.211|-0.718|0.0003
91510098|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.675||||0|TWO_SIDED|95.0|-0.928|-0.421||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.421|-0.928|0.0000
91510099|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.704||||0|TWO_SIDED|95.0|-0.957|-0.45||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.450|-0.957|0.0000
91510100|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.212||||0.1014|TWO_SIDED|95.0|-0.465|0.042||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.042|-0.465|0.1014
91510101|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.239||||0.064|TWO_SIDED|95.0|-0.492|0.014||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.014|-0.492|0.0640
91510102|NCT02139644|182892212|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.241||||0.0626|TWO_SIDED|95.0|-0.494|0.013||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.013|-0.494|0.0626
91510103|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||||||Significance level of 0.05|Log Rank|||||||0.1679
91510104|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1701||||||Significance level of 0.05|Log Rank|||||||0.1701
91510105|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0437||||||Significance level of 0.05|Log Rank|||||||0.0437
91510106|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||||||Significance level of 0.05|Log Rank|||||||0.1718
91510107|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3134||||||Significance level of 0.05|Log Rank|||||||0.3134
91510108|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.993||||||Significance level of 0.05|Log Rank|||||||0.9930
91510109|NCT02139644|182892213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Significance level of 0.05|Log Rank|||||||0.9999
91510110|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.301||||0.0044|TWO_SIDED|95.0|0.094|0.508||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.508|0.094|0.0044
91510111|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0155|TWO_SIDED|95.0|0.048|0.458||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.458|0.048|0.0155
91510112|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.27|0.676||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.676|0.270|0.0000
91510113|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.23||||0.0293|TWO_SIDED|95.0|0.023|0.437||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.437|0.023|0.0293
91510114|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.172||||0.0913|TWO_SIDED|95.0|-0.028|0.372||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.372|-0.028|0.0913
91533266|NCT04541186|182943695|SUPERIORITY||Least Squares Means Difference|1.73|STANDARD_ERROR_OF_MEAN|10.519||0.87|TWO_SIDED|95.0|-19.21|22.68||Significant level = 0.05|MMRM|||MMRM analysis of LDL-C comparison between pegozafermin pooled versus placebo pooled group.||22.68|-19.21|0.870
91533267|NCT04541186|182943695|SUPERIORITY||Least Squares Means Difference|15.41|STANDARD_ERROR_OF_MEAN|8.182||0.064|TWO_SIDED|95.0|-0.89|31.7||Significant level = 0.05|MMRM|||MMRM analysis of HDL-C comparison between pegozafermin pooled versus placebo pooled group.||31.70|-0.89|0.064
91533268|NCT04541186|182943696|SUPERIORITY|||||||0.006||||||Significant level = 0.05|van Elteren Test|||Nonparametric analysis of VLDL-C comparison between pegozafermin pooled versus placebo pooled group.||||0.006
91533269|NCT04541186|182943696|SUPERIORITY|||||||0.002||||||Significant level of 0.05|van Elteren test|||Nonparametric analysis of VLDL-TG comparison between pegozafermin pooled versus placebo pooled group.||||0.002
91533270|NCT04541186|182943697|SUPERIORITY|||||||0.809||||||Significant level = 0.05|MMRM|||MMRM analysis of fasting plasma glucose comparison between pegozafermin pooled versus placebo pooled group.||||0.809
91533271|NCT04541186|182943697|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|MMRM|||MMRM analysis of adiponectin comparison between pegozafermin pooled versus placebo pooled group.||||<0.001
91533272|NCT04541186|182943697|SUPERIORITY|||||||0.973||||||Significant level = 0.05|MMRM|||MMRM analysis of body weight comparison between pegozafermin pooled versus placebo pooled group.||||0.973
91533273|NCT04541186|182943698|SUPERIORITY|||||||0.012||||||Significant level = 0.05|ANCOVA|||||||0.012
91533274|NCT00058058|182943716|OTHER|Estimation of diagnostic yield|Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS||0.042|0.020|
91533275|NCT00058058|182943716|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.044||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up||0.044|0.021|
91533276|NCT00058058|182943716|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure||0.042|0.020|
91533277|NCT00058058|182943716|OTHER||Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan||0.042|0.020|
91533278|NCT00058058|182943716|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan||0.043|0.021|
91533279|NCT00058058|182943716|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up||0.043|0.021|
91533280|NCT00058058|182943717|OTHER||Binomial Proportion|0.9091|STANDARD_ERROR_OF_MEAN|0.05004|||TWO_SIDED|95.0|0.7567|0.9809||||||"Sensitivity estimate - estimates the P(T+\|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9809|0.7567|
91755854|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||68.89|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|68.89
91533281|NCT00058058|182943717|OTHER||Binomial Proportion|0.8782|STANDARD_ERROR_OF_MEAN|0.0107|||TWO_SIDED|95.0|0.8555|0.8985||||||"Specificity - estimates the P(T-\|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.8985|0.8555|
91533282|NCT00058058|182943717|OTHER||Binomial Proportion|0.2083|STANDARD_ERROR_OF_MEAN|0.0338|||TWO_SIDED|95.0|0.1452|0.2839||||||"PPV estimate - estimates the P(D+\|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)."||0.2839|0.1452|
91533283|NCT00058058|182943717|OTHER||Binomial Proportion|0.9964|STANDARD_ERROR_OF_MEAN|0.0021|||TWO_SIDED|95.0|0.9894|0.9993||||||"B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-\|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9993|0.9894|
91755855|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.19|TWO_SIDED|95.0|1.01|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|1.01|98.19
91533284|NCT00058058|182943717|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.00556|||TWO_SIDED|95.0|0.021|0.044||||||B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis||0.044|0.021|
91533285|NCT00058058|182943718|OTHER||ROC analysis|0.9355|||||TWO_SIDED|95.0|0.8956|0.9753|||||exact CI|ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast||0.9753|0.8956|
91533286|NCT00790062|182943741|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.67|TWO_SIDED|95.0|0.63|1.59|||ANCOVA|||||1.59|0.63|0.670
91533287|NCT02680756|182943742|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.298|TWO_SIDED|95.0|-0.28|-0.06|||t-test, 2 sided|||||-0.06|-0.28|0.298
91755856|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||94.07|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|94.07
91510115|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.023||||0.8216|TWO_SIDED|95.0|-0.223|0.177||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.177|-0.223|0.8216
91510116|NCT02139644|182892214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.071||||0.4934|TWO_SIDED|95.0|-0.275|0.133||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.133|-0.275|0.4934
91510117|NCT00630877|182892219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91510118|NCT00630877|182892221|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
91510119|NCT00630877|182892222|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
91510120|NCT00630877|182892223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
91510121|NCT00630877|182892224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
91510122|NCT00630877|182892225|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Independent groups t-test|||||||0.002
91510123|NCT00630877|182892226|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Independent groups t-test|||||||<0.001
91510124|NCT01312909|182892227|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6337|TWO_SIDED|95.0|0.59|2.37||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||2.37|0.59|0.6337
91510125|NCT01312909|182892227|SUPERIORITY||Odds Ratio (OR)|1.73||||0.1114|TWO_SIDED|95.0|0.88|3.39||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||3.39|0.88|0.1114
91510126|NCT01312909|182892228|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5793|TWO_SIDED|95.0|0.62|2.38|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||2.38|0.62|0.5793
91510127|NCT01312909|182892228|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0932|TWO_SIDED|95.0|0.91|3.51|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||3.51|0.91|0.0932
91510128|NCT01312909|182892228|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5647|TWO_SIDED|95.0|0.61|2.5|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.50|0.61|0.5647
91510129|NCT01312909|182892228|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2917|TWO_SIDED|95.0|0.72|2.96|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.96|0.72|0.2917
91510130|NCT01312909|182892228|SUPERIORITY||Odds Ratio (OR)|1.25||||0.5616|TWO_SIDED|95.0|0.58|2.69|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||2.69|0.58|0.5616
91510131|NCT01312909|182892228|SUPERIORITY||Odds Ratio (OR)|1.79||||0.13|TWO_SIDED|95.0|0.84|3.78|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||3.78|0.84|0.1300
91510132|NCT01312909|182892230|SUPERIORITY||Least square (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.58||0.354|TWO_SIDED|95.0|-1.69|0.6|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.60|-1.69|0.3540
91510133|NCT01312909|182892230|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.59||0.7574|TWO_SIDED|95.0|-1.35|0.98|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.98|-1.35|0.7574
91510134|NCT01312909|182892230|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.6||0.5676|TWO_SIDED|95.0|-1.53|0.84|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.84|-1.53|0.5676
91510135|NCT01312909|182892230|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.61||0.2356|TWO_SIDED|95.0|-1.92|0.47|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.47|-1.92|0.2356
91755857|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.74|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|75.74
91755858|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||95.83|TWO_SIDED|95.0|0.99|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.99|95.83
91755859|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||79.8|TWO_SIDED|95.0|0.94|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.94|79.80
91755860|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||95.29|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|95.29
91755861|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.27|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|96.27
91755862|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.62|TWO_SIDED|95.0|0.94|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.94|47.62
91759850|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.93|||||TWO_SIDED|95.0|-18.94|-2.92||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.92|-18.94|
91510136|NCT01312909|182892230|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.62||0.773|TWO_SIDED|95.0|-1.03|1.38|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||1.38|-1.03|0.7730
91510137|NCT01312909|182892230|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.62||0.2166|TWO_SIDED|95.0|-1.99|0.45|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.45|-1.99|0.2166
91510138|NCT01312909|182892231|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6133|TWO_SIDED|95.0|0.34|1.9|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||1.90|0.34|0.6133
91510139|NCT01312909|182892231|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0335|TWO_SIDED|95.0|1.07|4.79|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||4.79|1.07|0.0335
91510140|NCT01312909|182892231|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9874|TWO_SIDED|95.0|0.37|2.65|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||2.65|0.37|0.9874
91510141|NCT01312909|182892231|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0188|TWO_SIDED|95.0|1.19|6.55|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||6.55|1.19|0.0188
91510142|NCT01923181|182892252|SUPERIORITY|This hypothesis was controlled for multiplicity.|Mean treatment difference|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.22|||Mixed Models Analysis||Oral semaglutide 40 mg pooled - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.22|-1.73|<0.0001
91533288|NCT02680756|182943743|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.341|TWO_SIDED|95.0|-0.3|-0.05|||t-test, 2 sided|||||-0.05|-0.30|0.341
91533289|NCT02374957|182943764|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test)."||||0.26
91533290|NCT02374957|182943765|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test)."||||0.17
91533291|NCT02374957|182943766|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test)."||||0.027
91533292|NCT02374957|182943767|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test)."||||0.014
91533293|NCT02374957|182943768|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test)."||||0.82
91533294|NCT02374957|182943769|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test)."||||0.61
91533295|NCT02374957|182943770|SUPERIORITY|||||||0.26|||||||Log Rank|||"Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test)."||||0.26
91533296|NCT00562965|182943792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0358|TWO_SIDED|95.0|0.04|1.02|||Cox proportional hazard regression model|A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.||1.02|0.04|0.0358
91533297|NCT00562965|182943793|SUPERIORITY_OR_OTHER|||||||0.0801|TWO_SIDED||||||Fisher Exact|||||||0.0801
91533298|NCT00562965|182943794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1727|TWO_SIDED|95.0|0.05|1.81|||Cox proportional hazard regression model|Stratified Cox proportional hazard regression model was utilized.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|||1.81|0.05|0.1727
91533299|NCT01648283|182943806|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91533300|NCT01253200|182943829|NON_INFERIORITY_OR_EQUIVALENCE|The Primary Safety Endpoint was evaluated using a one-sided, non-inferiority test for two binomial proportions at an alpha-level of 0.05. A 95% confidence interval based upon a score test of the difference of proportion of subjects in the Investigational and Control Groups free from a procedure-related complication seven days post-procedure was constructed. The upper bound of the confidence interval was compared to 10%.|Risk Difference (RD)|4.6|||||ONE_SIDED|95.0||9.78||||||Note that analysis of the primary outcome was conducted for Randomized subjects only as prespecified in the study protocol. This is consistent analysis publicly available in the Summary of Safety and Effectiveness Data (SSED).||9.78||
91533301|NCT02049437|182943833|SUPERIORITY||Risk Ratio (RR)|4.43||||0.07|TWO_SIDED|95.0|0.9|21.83|||Mixed Models Analysis|||||21.83|0.90|0.07
91533302|NCT02049437|182943834|SUPERIORITY||Mean Difference (Final Values)|-2036.8|||<|0.001|TWO_SIDED|95.0|-3490.32|-900.62|||Wilcoxon (Mann-Whitney)|||||-900.62|-3490.32|<0.001
91533303|NCT02049437|182943835|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.77|TWO_SIDED|95.0|-0.79|0.65|||Wilcoxon (Mann-Whitney)|||||0.65|-0.79|0.77
91533304|NCT01163149|182943839|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-302.05||||0.0285|TWO_SIDED|95.0|-626.4|-59.2||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||PLP Change from Baseline to Week 24||-59.20|-626.40|0.0285
91533305|NCT01163149|182943840|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-1.825||||0.0715|TWO_SIDED|95.0|-3.21|0.23||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group.|PPi Change from Baseline to Week 24||0.230|-3.210|0.0715
91533306|NCT01163149|182943842|SUPERIORITY||Hodges-Lehmann-Sen|-0.91||||0.3301|TWO_SIDED|95.0|-3.32|1.78||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total BMC Change from Baseline to Week 24||1.780|-3.320|0.3301
91533307|NCT01163149|182943842|SUPERIORITY||Hodges-Lehmann-Sen|1.33||||0.3827|TWO_SIDED|95.0|-1.36|3.12||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMC Change from Baseline to Week 24||3.120|-1.360|0.3827
91533308|NCT01163149|182943842|SUPERIORITY||Hodges-Lehmann-Sen|-77.1||||0.0485|TWO_SIDED|95.0|-917.44|-1.74||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMC Change from Baseline to Week 24||-1.740|-917.440|0.0485
91759851|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.12|||||TWO_SIDED|95.0|-24.01|-8.24||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.24|-24.01|
91510143|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.4||||0.0069|TWO_SIDED|95.0|-0.69|-0.11|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.11|-0.69|0.0069
91510144|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.6|||Mixed Models Analysis||Oral semaglutide 5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.60|-1.18|<0.0001
91510145|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.9|||Mixed Models Analysis||Oral semaglutide 10 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.90|-1.47|<0.0001
91510146|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.09|||Mixed Models Analysis||Oral Semaglutide 20 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.09|-1.68|<0.0001
91510147|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.3|||Mixed Models Analysis||Oral semaglutide 40 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.30|-1.89|<0.0001
91510148|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.14|||Mixed Models Analysis||Oral semaglutide 40 mg slow dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.14|-1.72|<0.0001
91510149|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.64|-1.04|||Mixed Models Analysis||Oral semaglutide 40 mg fast dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.04|-1.64|<0.0001
91510150|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.27|||Mixed Models Analysis||Subcutaneous semaglutide 1 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.27|-1.85|<0.0001
91510151|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.87|1.45|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||1.45|0.87|<0.0001
91510152|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.67|||<|0.0001|TWO_SIDED|95.0|0.38|0.96|||Mixed Models Analysis||Oral semaglutide 5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.96|0.38|<0.0001
91510153|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.37||||0.0116|TWO_SIDED|95.0|0.08|0.67|||Mixed Models Analysis||Oral semaglutide 10 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.67|0.08|0.0116
91533309|NCT01163149|182943843|SUPERIORITY||Hodges-Lehmann-Sen|-0.0125||||0.7357|TWO_SIDED|95.0|-0.04|0.039||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total Change from Baseline to Week 24||0.0390|-0.0400|0.7357
91533310|NCT01163149|182943843|SUPERIORITY||Hodges-Lehmann-Sen|0.0255||||0.2439|TWO_SIDED|95.0|-0.009|0.041||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMD Change from Baseline to Week 24||0.0410|-0.0090|0.2439
91755863|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||71.55|TWO_SIDED|95.0|0.92|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.92|71.55
91755864|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.29|TWO_SIDED|95.0|1.01|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|1.01|98.29
91755865|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Bayesian repeated measures model|1.08||||95.09|TWO_SIDED|95.0|0.99|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.99|95.09
91755866|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||93.68|TWO_SIDED|95.0|0.98|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.98|93.68
91510154|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.18||||0.244|TWO_SIDED|95.0|-0.12|0.47|||Mixed Models Analysis||Oral semaglutide 20 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.47|-0.12|0.2440
91510155|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.04||||0.7973|TWO_SIDED|95.0|-0.34|0.26|||Mixed Models Analysis||Oral semaglutide 40 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.26|-0.34|0.7973
91510156|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.13||||0.3901|TWO_SIDED|95.0|-0.16|0.42|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.42|-0.16|0.3901
91510157|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.22||||0.1612|TWO_SIDED|95.0|-0.09|0.52|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.52|-0.09|0.1612
91510158|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.17||||0.2669|TWO_SIDED|95.0|-0.13|0.46|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.46|-0.13|0.2669
91510159|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.26||||0.0989|TWO_SIDED|95.0|-0.05|0.56|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.56|-0.05|0.0989
91510160|NCT01923181|182892252|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.09||||0.5565|TWO_SIDED|95.0|-0.21|0.39|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg slow-dose escalation|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.39|-0.21|0.5565
91510161|NCT00739336|182892276|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in -2LL).||||<0.01
91510162|NCT01993108|182892296|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||.02
91510163|NCT01993108|182892296|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||.118
91510164|NCT01993108|182892296|SUPERIORITY||Median Difference (Final Values)|0.02||||0.349|TWO_SIDED||||||t-test, 2 sided|||||||.349
91510165|NCT01993108|182892296|SUPERIORITY||Median Difference (Final Values)|0.02||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
91510166|NCT01993108|182892297|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||.019
91510167|NCT01993108|182892297|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||.240
91510168|NCT01993108|182892297|SUPERIORITY||Median Difference (Final Values)|0.06||||0.081|TWO_SIDED||||||t-test, 2 sided|||||||.081
91510169|NCT01993108|182892297|SUPERIORITY||Median Difference (Final Values)|0.04||||0.247|TWO_SIDED||||||t-test, 2 sided|||||||.247
91510170|NCT01993108|182892298|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.049|TWO_SIDED||||||t-test, 2 sided|||||||.049
91510171|NCT01993108|182892298|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||.497
91510172|NCT01993108|182892298|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.814|TWO_SIDED||||||t-test, 2 sided|||||||.814
91510173|NCT01993108|182892298|SUPERIORITY||Mean Difference (Net)|0.01||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||.593
91510174|NCT01993108|182892299|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.926|TWO_SIDED||||||t-test, 2 sided|||||||.926
91510175|NCT01993108|182892299|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.126|TWO_SIDED||||||t-test, 2 sided|||||||.126
91510176|NCT01993108|182892299|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.852|TWO_SIDED||||||t-test, 2 sided|||||||.852
91510177|NCT01993108|182892299|SUPERIORITY||Median Difference (Final Values)|0.11||||0.552|TWO_SIDED||||||t-test, 2 sided|||||||.552
91510178|NCT01560624|182892300|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0275|TWO_SIDED|95.0|0.56|0.97|||Cox proportion-hazard model|||||0.97|0.56|0.0275
91510179|NCT01560624|182892300|SUPERIORITY|||||||0.0391|||||||Log Rank|||||||0.0391
91510180|NCT01560624|182892301|SUPERIORITY||Hodges Lehmann estimate location shift|7.0||||0.0913|TWO_SIDED|95.0|0.0|16.0|||ANCOVA|||||16.0|0|0.0913
91510181|NCT01560624|182892302|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91510182|NCT01560624|182892303|SUPERIORITY|||||||0.0028|||||||Fisher Exact|||||||0.0028
91510183|NCT02099721|182892304|EQUIVALENCE|The equivalence margin is a hazard ratio significantly above 0.70.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.38|0.57|||||The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator.|"H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70~HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) \> 0.70"||0.57|0.38|
91510184|NCT02099721|182892305|SUPERIORITY|A hazard ratio significantly below 1 indicates reduced mortality in the 1.5 implanted group.|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.4|0.66||The p-value is for the effect of treatment group on time to death, adjusting for the baseline covariates of age, gender, QRS duration, ischemic cardiomyopathy, LBBB, NYHA classification, diabetes, LVEF, syncope, NSVT and PVCs.|Wald chi-square||Multiple imputations were employed to account for missing baseline covariates.|The null hypothesis is that the hazard ratio of implanted to non-implanted 1.5 patients = 1. The alternative is that the ratio is not equal to 1.||0.66|0.40|< 0.0001
91510185|NCT00844545|182892316|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols: C08-002A (adult) and C08-002B (adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
91510186|NCT00844545|182892317|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
91510187|NCT00844545|182892318|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
91510188|NCT00844545|182892319|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
91510189|NCT00844545|182892320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
91510190|NCT00844545|182892321|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
91510191|NCT00844545|182892322|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
91510192|NCT00844545|182892323|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
91533311|NCT01163149|182943843|SUPERIORITY||Hodges-Lehmann-Sen|-0.0315||||0.1222|TWO_SIDED|95.0|-0.059|0.012||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMD Change from Baseline to Week 24||0.0120|-0.0590|0.1222
91755867|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.58|TWO_SIDED|95.0|1.0|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|1.00|96.58
91755868|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||56.99|TWO_SIDED|95.0|0.95|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.95|56.99
91755869|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||13.08|TWO_SIDED|95.0|0.85|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.85|13.08
91510193|NCT00844545|182892324|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
91510194|NCT00844545|182892325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
91510195|NCT04574362|182892335|SUPERIORITY||Risk Difference (RD)|9.2|||<|0.0001|TWO_SIDED|95.0|5.4|13.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95 percent (%) confidence interval (CI) were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||13.0|5.4|<0.0001
91510196|NCT04574362|182892336|SUPERIORITY||Risk Difference (RD)|14.8|||<|0.0001|TWO_SIDED|95.0|9.6|20.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||20.0|9.6|<0.0001
91510197|NCT04574362|182892337|SUPERIORITY||Risk Difference (RD)|18.1|||<|0.0001|TWO_SIDED|95.0|13.0|23.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||23.3|13.0|<0.0001
91510198|NCT04574362|182892338|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|11.4|22.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||22.3|11.4|<0.0001
91510199|NCT04574362|182892339|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.0|-8.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||-8.0|-15.0|<0.0001
91510200|NCT04574362|182892340|SUPERIORITY||Risk Difference (RD)|7.7|||<|0.0001|TWO_SIDED|95.0|4.3|11.2|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk differences and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.2|4.3|<0.0001
91510201|NCT04574362|182892341|SUPERIORITY||Risk difference|7.7|||<|0.0001|TWO_SIDED|95.0|4.4|11.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.0|4.4|<0.0001
91510202|NCT04574362|182892342|SUPERIORITY||Risk difference|-0.7||||0.2057|TWO_SIDED|95.0|-1.9|0.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||0.4|-1.9|0.2057
91510203|NCT04574362|182892342|SUPERIORITY||Risk Difference (RD)|0.0||||0.9702|TWO_SIDED|95.0|-1.1|1.1||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||1.1|-1.1|0.9702
91510204|NCT04574362|182892342|SUPERIORITY||Risk Difference (RD)|1.0||||0.2419|TWO_SIDED|95.0|-0.7|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||2.8|-0.7|0.2419
91510205|NCT04574362|182892342|SUPERIORITY||Risk Difference (RD)|2.4||||0.0597|TWO_SIDED|95.0|-0.1|4.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||4.8|-0.1|0.0597
91755870|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.99|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.99
91755871|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||60.75|TWO_SIDED|95.0|0.9|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.90|60.75
91510206|NCT04574362|182892342|SUPERIORITY||Risk Difference (RD)|5.2||||0.0012|TWO_SIDED|95.0|2.1|8.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||8.4|2.1|0.0012
91510207|NCT04574362|182892343|SUPERIORITY||Risk Difference (RD)|-0.7||||0.6809|TWO_SIDED|95.0|-3.9|2.5||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||2.5|-3.9|0.6809
91510208|NCT04574362|182892343|SUPERIORITY||Risk Difference (RD)|2.2||||0.2586|TWO_SIDED|95.0|-1.6|6.0||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||6.0|-1.6|0.2586
91510209|NCT04574362|182892343|SUPERIORITY||Risk Difference (RD)|4.5||||0.0421|TWO_SIDED|95.0|0.2|8.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||8.8|0.2|0.0421
91510210|NCT04574362|182892343|SUPERIORITY||Risk Difference (RD)|6.6||||0.0066|TWO_SIDED|95.0|1.8|11.3||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||11.3|1.8|0.0066
91510211|NCT04574362|182892343|SUPERIORITY||Risk Difference (RD)|9.9||||0.0002|TWO_SIDED|95.0|4.8|14.9||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||14.9|4.8|0.0002
91510212|NCT04574362|182892344|SUPERIORITY||Risk Difference (RD)|-10.4||||0.1148|TWO_SIDED|95.0|-23.5|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||2.8|-23.5|0.1148
91510213|NCT03670810|182892388|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.56|5.73|||Regression, Logistic|||||5.73|2.56|<0.001
91510214|NCT03670810|182892388|SUPERIORITY||Odds Ratio (OR)|4.56|||<|0.001|TWO_SIDED|95.0|3.07|6.77|||Regression, Logistic|||||6.77|3.07|<0.001
91510215|NCT03670810|182892389|SUPERIORITY||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.1|6.76|||Regression, Logistic|||||6.76|2.10|<.001
91510216|NCT03670810|182892389|SUPERIORITY||Odds Ratio (OR)|7.24|||<|0.001|TWO_SIDED|95.0|4.13|12.67|||Regression, Logistic|||||12.67|4.13|<.001
91510217|NCT03670810|182892390|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|2.05|3.57|||Regression, Logistic|||||3.57|2.05|<0.001
91510218|NCT03670810|182892390|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.001|TWO_SIDED|95.0|2.04|3.53|||Regression, Logistic|||||3.53|2.04|<0.001
91510219|NCT03670810|182892391|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.11|4.01|||Regression, Logistic|||||4.01|2.11|<0.001
91510220|NCT03670810|182892391|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.53|4.85|||Regression, Logistic|||||4.85|2.53|<0.001
91510221|NCT03670810|182892392|SUPERIORITY||Odds Ratio (OR)|3.52|||<|0.001|TWO_SIDED|95.0|2.05|6.02|||Regression, Logistic|||||6.02|2.05|<0.001
91510222|NCT03670810|182892392|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.001|TWO_SIDED|95.0|2.77|7.88|||Regression, Logistic|||||7.88|2.77|<0.001
91510223|NCT03670810|182892393|SUPERIORITY||Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.04|||Regression, Logistic|||||4.04|1.30|0.004
91510224|NCT03670810|182892393|SUPERIORITY||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.41|6.94|||Regression, Logistic|||||6.94|2.41|<0.001
91510225|NCT03670810|182892394|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|1.8|6.02|||Regression, Logistic|||||6.02|1.80|<0.001
91510226|NCT03670810|182892394|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.97|6.42|||Regression, Logistic|||||6.42|1.97|<0.001
91510227|NCT03670810|182892395|SUPERIORITY||Odds Ratio (OR)|2.22|||<|0.001|TWO_SIDED|95.0|1.48|3.33|||Regression, Logistic|||||3.33|1.48|<0.001
91510228|NCT03670810|182892395|SUPERIORITY||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.65|3.67|||Regression, Logistic|||||3.67|1.65|<0.001
91510229|NCT03670810|182892396|SUPERIORITY||Odds Ratio (OR)|2.73||||0.031|TWO_SIDED|95.0|1.1|6.78|||Regression, Logistic|||||6.78|1.10|0.031
91510230|NCT03670810|182892396|SUPERIORITY||Odds Ratio (OR)|5.64|||<|0.001|TWO_SIDED|95.0|2.4|13.25|||Regression, Logistic|||||13.25|2.40|<0.001
91510231|NCT03670810|182892397|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.29|2.35|||Regression, Logistic|||||2.35|1.29|<0.001
91510232|NCT03670810|182892397|SUPERIORITY||Odds Ratio (OR)|1.63||||0.001|TWO_SIDED|95.0|1.21|2.2|||Regression, Logistic|||||2.20|1.21|0.001
91510233|NCT03670810|182892398|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Regression, Logistic|||||0.65|0.33|<0.001
91755872|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.23|TWO_SIDED|95.0|0.92|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.92|75.23
91755873|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||28.14|TWO_SIDED|95.0|0.78|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.78|28.14
91755874|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||38.43|TWO_SIDED|95.0|0.84|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.84|38.43
91755875|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||25.21|TWO_SIDED|95.0|0.8|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.80|25.21
91510234|NCT03670810|182892398|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||||0.60|0.30|<0.001
91510235|NCT03670810|182892399|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.79|4.28|||Regression, Logistic|||||4.28|1.79|<0.001
91510236|NCT03670810|182892399|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.2|5.15|||Regression, Logistic|||||5.15|2.20|<0.001
91510237|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|6.4||||0.086|TWO_SIDED|95.0|0.77|53.37|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||53.37|0.77|0.086
91510238|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|7.24||||0.065|TWO_SIDED|95.0|0.89|59.08|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||59.08|0.89|0.065
91510239|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|3.08||||0.004|TWO_SIDED|95.0|1.42|6.68|||Regression, Logistic|||Pain Free 1 Hour Postdose||6.68|1.42|0.004
91510240|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|7.04|||<|0.001|TWO_SIDED|95.0|3.43|14.44|||Regression, Logistic|||Pain Free 1 Hour Postdose||14.44|3.43|<0.001
91510241|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|1.41||||0.065|TWO_SIDED|95.0|0.98|2.03|||Regression, Logistic|||Pain Relief 30 Min Postdose 100 mg||2.03|0.98|0.065
91510242|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|1.77||||0.001|TWO_SIDED|95.0|1.25|2.52|||Regression, Logistic|||Pain Relief 30 Min. Postdose 200 mg||2.52|1.25|0.001
91510243|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.001|TWO_SIDED|95.0|1.74|3.06|||Regression, Logistic|||Pain Relief 1 Hour Postdose 100 mg||3.06|1.74|<0.001
91510244|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.64|2.88|||Regression, Logistic|||Pain Relief 1 Hour Postdose 200 mg||2.88|1.64|<0.001
91510245|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|1.11||||0.651|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic|||Freedom from MBS 30 Min 100 mg||1.71|0.71|0.651
91510246|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|1.3||||0.22|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Freedom from MBS 30 Min. 200 mg||1.98|0.85|0.220
91510247|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|1.1||||0.593|TWO_SIDED|95.0|0.78|1.54|||Regression, Logistic|||Freedom from MBS 1 Hour 100 mg||1.54|0.78|0.593
91510248|NCT03670810|182892401|SUPERIORITY||Odds Ratio (OR)|1.43||||0.03|TWO_SIDED|95.0|1.04|1.98|||Regression, Logistic|||Freedom from MBS 1 Hour 200 mg||1.98|1.04|0.030
91510249|NCT03670810|182892402|SUPERIORITY|||||||0.092|||||||ANCOVA|||||||0.092
91510250|NCT03670810|182892402|SUPERIORITY|||||||0.211|||||||ANCOVA|||||||0.211
91510251|NCT03670810|182892403|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.001|TWO_SIDED|95.0|2.01|4.05|||Regression, Logistic|||||4.05|2.01|<0.001
91510252|NCT03670810|182892403|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|2.12|4.26|||Regression, Logistic|||||4.26|2.12|<0.001
91510253|NCT03670810|182892404|SUPERIORITY|||||||0.056|||||||ANOVA|||Social Functioning||||0.056
91510254|NCT03670810|182892404|SUPERIORITY|||||||0.267|||||||ANOVA|||Social Functioning||||0.267
91510255|NCT03670810|182892404|SUPERIORITY|||||||0.003|||||||ANOVA|||Migraine Symptoms 100 mg||||0.003
91510256|NCT03670810|182892404|SUPERIORITY|||||||0.002|||||||ANOVA|||Migraine Symptoms 200 mg||||0.002
91510257|NCT03670810|182892404|SUPERIORITY|||||||0.014|||||||ANOVA|||Feeling/Concerns 100 mg||||0.014
91510258|NCT03670810|182892404|SUPERIORITY|||||||0.018|||||||ANOVA|||Feelings/Concerns 200 mg||||0.018
91510259|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|1.25||||0.101|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Recommend Treatment - Agree Strongly Agree||1.62|0.96|0.101
91755876|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||81.73|TWO_SIDED|95.0|0.91|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.91|81.73
91755877|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.87|TWO_SIDED|95.0|0.76|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.76|9.87
91510260|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|1.28||||0.063|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Recommend Treatment Agree/Strongly Agree||1.67|0.99|0.063
91533312|NCT01163149|182943844|SUPERIORITY||Hodges-Lehmann-Sen|44.0||||0.1303|TWO_SIDED|95.0|-73.0|114.0||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group|Week 24 Change from Baseline||114.0|-73.0|0.1303
91510261|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.16|0.68|0.376
91510262|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|0.79||||0.082|TWO_SIDED|95.0|0.6|1.03|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.03|0.60|0.082
91510263|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|1.25||||0.096|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Extremely/Very Satisfied||1.62|0.96|0.096
91755878|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||63.15|TWO_SIDED|95.0|0.87|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.87|63.15
91755879|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.86|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.86|4.03
91510264|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|1.38||||0.016|TWO_SIDED|95.0|1.06|1.8|||Regression, Logistic|||Extremely/Very Satisfied||1.80|1.06|0.016
91510265|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|1.12||||0.445|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Prefer This Treatment||1.49|0.84|0.445
91510266|NCT03670810|182892405|SUPERIORITY||Odds Ratio (OR)|1.19||||0.243|TWO_SIDED|95.0|0.89|1.58|||Regression, Logistic|||||1.58|0.89|0.243
91510267|NCT03670810|182892406|SUPERIORITY|||||||0.142|||||||ANCOVA|||||||0.142
91510268|NCT03670810|182892407|SUPERIORITY||Odds Ratio (OR)|3.01||||0.004|TWO_SIDED|95.0|1.42|6.4|||Regression, Logistic|||||6.40|1.42|0.004
91510269|NCT03670810|182892407|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.22|9.47|||Regression, Logistic|||||9.47|2.22|<0.001
91510270|NCT03670810|182892408|SUPERIORITY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.74|3.62|||Regression, Logistic|||||3.62|1.74|<0.001
91510271|NCT03670810|182892408|SUPERIORITY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.5|5.2|||Regression, Logistic|||||5.20|2.50|<0.001
91510272|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|1.01||||0.953|TWO_SIDED|95.0|0.75|1.36|||Regression, Logistic|||Nausea||1.36|0.75|0.953
91510273|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|1.05||||0.768|TWO_SIDED|95.0|0.78|1.41|||Regression, Logistic|||Nausea||1.41|0.78|0.768
91510274|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Logistic|||Phonophobia||0.71|0.39|<0.001
91510275|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.34|0.62|||Regression, Linear|||Phonophobia||0.62|0.34|<0.001
91510276|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.63|||Regression, Logistic|||Photophobia||0.63|0.36|<0.001
91510277|NCT03670810|182892409|SUPERIORITY||Median Difference (Net)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71|||Regression, Logistic|||Photophobia||0.71|0.40|<0.001
91510278|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|0.46||||0.129|TWO_SIDED|95.0|0.17|1.25|||Regression, Logistic|||Vomiting||1.25|0.17|0.129
91510279|NCT03670810|182892409|SUPERIORITY||Odds Ratio (OR)|1.12||||0.769|TWO_SIDED|95.0|0.52|2.43|||Regression, Logistic|||Vomiting||2.43|0.52|0.769
91510280|NCT00678691|182892410|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||all p-values come from one model analysis and are therefore included in free text as such|piecewise model|A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 - week 8||Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 - week 8).||||<0.05
91510281|NCT00780572|182892491|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9396||||0.668|TWO_SIDED|95.0|0.7068|1.249|||Regression, Cox|||||1.2490|0.7068|0.6680
91510282|NCT00727857|182892503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||<|0.0001||95.0|0.51|1.22|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||1.22|0.51|<0.0001
91510283|NCT00727857|182892503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|||<|0.0001||95.0|0.5|1.18|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.18|0.50|<0.0001
91510284|NCT00727857|182892503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8919||95.0|-0.37|0.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.33|-0.37|0.8919
91510285|NCT00727857|182892504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8||||0.0005||95.0|7.8|27.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||27.7|7.8|0.0005
91533313|NCT01700530|182943848|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91755880|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
91755881|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||80.34|TWO_SIDED|95.0|0.95|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.95|80.34
91755882|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||25.65|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|25.65
91755883|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.36|TWO_SIDED|95.0|0.88|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.88|24.36
91755884|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.45|TWO_SIDED|95.0|0.91|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.91|48.45
91755885|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||1.95|TWO_SIDED|95.0|0.81|0.99||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.99|0.81|1.95
91755886|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||14.15|TWO_SIDED|95.0|0.85|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.85|14.15
91510286|NCT00727857|182892504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.0021||95.0|5.5|24.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||24.7|5.5|0.0021
91510287|NCT00727857|182892504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.5981||95.0|-12.5|7.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.2|-12.5|0.5981
91510288|NCT00727857|182892505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.5074||95.0|-1.43|2.88|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.88|-1.43|0.5074
91510289|NCT00727857|182892505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.93||||0.0047||95.0|0.9|4.95|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.95|0.90|0.0047
91510290|NCT00727857|182892505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.0435||95.0|0.06|4.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.33|0.06|0.0435
91755887|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||80.61|TWO_SIDED|95.0|0.95|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.95|80.61
91755888|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||3.3|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.30
91510291|NCT00727857|182892506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629||||0.3158||95.0|-0.602|1.861|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.861|-0.602|0.3158
91510292|NCT00727857|182892506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.619||||0.0067||95.0|0.452|2.785|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.785|0.452|0.0067
91510293|NCT00727857|182892506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.989||||0.1094||95.0|-0.223|2.201|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.201|-0.223|0.1094
91510294|NCT00727857|182892507|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.88||||0.5963||95.0|-4.71|13.97|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||13.97|-4.71|0.5963
91510295|NCT00727857|182892507|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.81||||0.0265||95.0|2.88|22.24|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||22.24|2.88|0.0265
91510296|NCT00727857|182892507|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|8.33||||0.1053||95.0|-1.77|18.07|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||18.07|-1.77|0.1053
91510297|NCT00727857|182892508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.0806||95.0|-0.2|3.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.1|-0.2|0.0806
91510298|NCT00727857|182892508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-9.6|-6.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-6.5|-9.6|<0.0001
91510299|NCT00727857|182892508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001||95.0|-11.1|-7.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-7.9|-11.1|<0.0001
91510300|NCT00727857|182892509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.73||||0.0324||95.0|0.31|7.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.14|0.31|0.0324
91510301|NCT00727857|182892509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78||||0.0233||95.0|-7.05|-0.52|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.52|-7.05|0.0233
91510302|NCT00727857|182892509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.0001||95.0|-10.9|-4.12|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-10.90|<0.0001
91510303|NCT00727857|182892510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.0993||95.0|-0.93|10.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.72|-0.93|0.0993
91533314|NCT01251614|182943917|SUPERIORITY_OR_OTHER||Difference|-25.5||||0.027|TWO_SIDED|95.0|-47.2|-3.7|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||-3.7|-47.2|0.027
91510304|NCT00727857|182892510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.367||95.0|-8.14|3.01|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.01|-8.14|0.3670
91510305|NCT00727857|182892510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.46||||0.0119||95.0|-13.26|-1.66|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-1.66|-13.26|0.0119
91755889|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.22|TWO_SIDED|95.0|0.88|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.88|42.22
91755890|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||95.24|TWO_SIDED|95.0|0.99|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.99|95.24
91510306|NCT00727857|182892511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31||||0.0423||95.0|-8.48|-0.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.15|-8.48|0.0423
91510307|NCT00727857|182892511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-12.08|-4.12|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-12.08|<0.0001
91755891|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.38|TWO_SIDED|95.0|0.83|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.83|6.38
91755892|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||28.82|TWO_SIDED|95.0|0.86|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.86|28.82
91755893|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||87.39|TWO_SIDED|95.0|0.97|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.97|87.39
91755894|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.27|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.27
91755895|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.82|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.82
91755896|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.67|TWO_SIDED|95.0|0.77|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.77|9.67
91755897|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.73|TWO_SIDED|95.0|0.89|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.89|70.73
91755898|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.61|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|25.61
91755899|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.1|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|44.10
91533315|NCT01251614|182943918|SUPERIORITY_OR_OTHER||Difference|-20.0||||0.083|TWO_SIDED|95.0|-42.2|2.2|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||2.2|-42.2|0.083
91533316|NCT01251614|182943919|SUPERIORITY_OR_OTHER||Difference|-7.3||||0.466|TWO_SIDED|95.0|-26.9|12.3|||Chi-squared|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||12.3|-26.9|0.466
91533317|NCT01251614|182943920|SUPERIORITY_OR_OTHER||Difference|-15.7||||0.056|TWO_SIDED|95.0|-29.1|-2.3|||Fisher Exact|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.3|-29.1|0.056
91533318|NCT01251614|182943921|SUPERIORITY_OR_OTHER||Difference|1.61||||0.304|TWO_SIDED|95.0|-1.48|4.7|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||4.70|-1.48|0.304
91533319|NCT01251614|182943922|SUPERIORITY_OR_OTHER||Difference|-8.88||||0.005|TWO_SIDED|95.0|-14.94|-2.82|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.82|-14.94|0.005
91533320|NCT01251614|182943923|SUPERIORITY_OR_OTHER||Difference|-28.3||||0.113|TWO_SIDED|95.0|-60.6|4.0|||Chi-squared|||"The difference between the combined adalimumab 0.8 mg/kg + MTX groups versus the adalimumab 0.4 mg/kg group.~Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were to be 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank."||4.0|-60.6|0.113
91533321|NCT01251614|182943924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.343|TWO_SIDED|95.0|0.66|3.17|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.17|0.66|0.343
91533322|NCT01251614|182943924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.276|TWO_SIDED|95.0|0.71|3.21|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.21|0.71|0.276
91533323|NCT03635112|182943985|SUPERIORITY||Least Square Mean Difference|-0.76||||0.97|TWO_SIDED|95.0|-40.62|39.11|||Mixed Model Repeated Measures Analysis|||||39.11|-40.62|0.970
91533324|NCT03635112|182943985|SUPERIORITY||Least Square Mean Difference|-13.13||||0.51|TWO_SIDED|95.0|-52.46|26.19|||Mixed Model Repeated Measures Analysis|||||26.19|-52.46|0.510
91510308|NCT00727857|182892511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79||||0.728||95.0|-7.93|0.35|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.35|-7.93|0.728
91510309|NCT00727857|182892512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.9231||95.0|-7.94|8.76|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.76|-7.94|0.9231
91510310|NCT00727857|182892512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16||||0.3082||95.0|-3.86|12.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.19|-3.86|0.3082
91510311|NCT00727857|182892512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.3753||95.0|-4.56|12.07|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.07|-4.56|0.3753
91510312|NCT00727857|182892513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.4999||95.0|-44.6|91.4|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||91.4|-44.6|0.4999
91510313|NCT00727857|182892513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.2||||0.0531||95.0|-0.9|129.3|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||129.3|-0.9|0.0531
91533325|NCT03635112|182943986|SUPERIORITY||Difference in Proportion|-0.07||||0.5102|TWO_SIDED|95.0|-0.277|0.135|||Cochran-Mantel-Haenszel Chi-square Test|||||0.135|-0.277|0.5102
91510314|NCT00727857|182892513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.9||||0.2369||95.0|-26.9|108.7|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||108.7|-26.9|0.2369
91510315|NCT00727857|182892514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.5023||95.0|-0.09|0.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.19|-0.09|0.5023
91533326|NCT03635112|182943986|SUPERIORITY||Difference in Proportion|0.02||||0.8591|TWO_SIDED|95.0|-0.181|0.218|||Cochran-Mantel-Haenszel Chi-square Test|||||0.218|-0.181|0.8591
91755900|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||10.14|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|10.14
91510316|NCT00727857|182892514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.0001||95.0|-0.48|-0.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.21|-0.48|<0.0001
91510317|NCT00727857|182892514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.0001||95.0|-0.53|-0.25|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.25|-0.53|<0.0001
91510318|NCT00727857|182892515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7||||0.2849||95.0|-16.5|55.9|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||55.9|-16.5|0.2849
91510319|NCT00727857|182892515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.6|||<|0.0001||95.0|-112.4|-42.8|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-42.8|-112.4|<0.0001
91510320|NCT00727857|182892515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.3|||<|0.0001||95.0|-133.4|-61.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-61.2|-133.4|<0.0001
91510321|NCT00727857|182892516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.2894||95.0|-4.5|15.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.1|-4.5|0.2894
91510322|NCT00727857|182892516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8463||95.0|-10.3|8.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.5|-10.3|0.8463
91510323|NCT00727857|182892516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2124||95.0|-16.0|3.6|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.6|-16.0|0.2124
91510324|NCT00727857|182892517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.804||95.0|-19.4|15.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.0|-19.4|0.8040
91510325|NCT00727857|182892517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5||||0.0008||95.0|12.0|45.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||45.0|12.0|0.0008
91510326|NCT00727857|182892517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.6||||0.0005||95.0|13.4|47.8|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||47.8|13.4|0.0005
91510327|NCT00727857|182892518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.9604||95.0|-83.3|79.2|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||79.2|-83.3|0.9604
91510328|NCT00727857|182892518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.3||||0.0004||95.0|62.5|218.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||218.0|62.5|0.0004
91510329|NCT00727857|182892518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.3||||0.0006||95.0|61.3|223.3|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||223.3|61.3|0.0006
91510330|NCT00727857|182892519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9922||95.0|-64.4|65.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||65.1|-64.4|0.9922
91510331|NCT00727857|182892519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.7||||0.0004||95.0|49.7|173.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||173.7|49.7|0.0004
91510332|NCT00727857|182892519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.4||||0.0008||95.0|46.8|175.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||175.9|46.8|0.0008
91510333|NCT00727857|182892520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0072||95.0|-1.86|-0.29|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.29|-1.86|0.0072
91510334|NCT00727857|182892520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.3682||95.0|-0.41|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.41|0.3682
91755901|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.87|TWO_SIDED|95.0|0.9|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.90|62.87
91755902|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||11.82|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|11.82
91755903|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.44|TWO_SIDED|95.0|0.95|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.95|51.44
91759852|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-13.45|2.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.56|-13.45|
91510335|NCT00727857|182892520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42||||0.0004||95.0|0.64|2.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.20|0.64|0.0004
91510336|NCT00727857|182892521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1986||95.0|-0.02|0.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.10|-0.02|0.1986
91510337|NCT00727857|182892521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1487||95.0|-0.1|0.02|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-0.10|0.1487
91510338|NCT00727857|182892521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.0076||95.0|-0.14|-0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.02|-0.14|0.0076
91510339|NCT00727857|182892522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.2384||95.0|-0.21|0.83|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.83|-0.21|0.2384
91510340|NCT00727857|182892522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4617||95.0|-0.69|0.31|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.31|-0.69|0.4617
91510341|NCT00727857|182892522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0593||95.0|-1.02|0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-1.02|0.0593
91510342|NCT00727857|182892523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.5044||95.0|-0.54|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.54|0.5044
91510343|NCT00727857|182892523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.0004||95.0|-2.22|-0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.64|-2.22|0.0004
91510344|NCT00727857|182892523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||<|0.0001||95.0|-2.53|-0.89|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.89|-2.53|<0.0001
91510345|NCT00727857|182892524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0017||95.0|-2.64|-0.62|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.62|-2.64|0.0017
91510346|NCT00727857|182892524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001||95.0|1.01|2.94|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.94|1.01|<0.0001
91510347|NCT00727857|182892524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|||<|0.0001||95.0|2.59|4.61|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.61|2.59|<0.0001
91510348|NCT00727857|182892525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76||||0.2466||95.0|-2.61|10.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.14|-2.61|0.2466
91510349|NCT00727857|182892525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.52||||0.0063||95.0|-14.63|-2.42|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.42|-14.63|0.0063
91533327|NCT03635112|182943987|SUPERIORITY||Difference in Proportion|-0.13||||0.1805|TWO_SIDED|95.0|-0.322|0.061|||Cochran-Mantel-Haenszel Chi-square Test|||||0.061|-0.322|0.1805
91755904|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||9.54|TWO_SIDED|95.0|0.88|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.88|9.54
91533328|NCT03635112|182943987|SUPERIORITY||Difference in Proportion|-0.01||||0.9215|TWO_SIDED|95.0|-0.204|0.184|||Cochran-Mantel-Haenszel Chi-square Test|||||0.184|-0.204|0.9215
91533329|NCT03635112|182943988|SUPERIORITY||Least Square Mean Difference|1.6||||0.316|TWO_SIDED|95.0|-1.6|4.8|||ANCOVA|||||4.8|-1.6|0.316
91533330|NCT03635112|182943988|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-3.2|3.2|||ANCOVA|||||3.2|-3.2|0.988
91533331|NCT03635112|182943989|SUPERIORITY||Difference in Proportion|-0.11||||0.1828|TWO_SIDED|95.0|-0.27|0.059|||Cochran-Mantel-Haenszel Chi-square Test|||||0.059|-0.270|0.1828
91755905|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
91755906|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||73.03|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.03
91755907|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||4.64|TWO_SIDED|95.0|0.83|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.83|4.64
91755908|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.13|TWO_SIDED|95.0|0.89|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.89|42.13
91755909|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||93.33|TWO_SIDED|95.0|0.98|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.98|93.33
91755910|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||27.33|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|27.33
91533332|NCT03635112|182943989|SUPERIORITY||Difference in Proportion|0.06||||0.5785|TWO_SIDED|95.0|-0.133|0.244|||Cochran-Mantel-Haenszel Chi-square Test|||||0.244|-0.133|0.5785
91533333|NCT03635112|182943990|SUPERIORITY||Difference in Proportion|-0.07||||0.3776|TWO_SIDED|95.0|-0.225|0.095|||Cochran-Mantel-Haenszel Chi-square Test|||||0.095|-0.225|0.3776
91759853|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.09|-6.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.11|-22.09|
91533334|NCT03635112|182943990|SUPERIORITY||Difference in Proportion|-0.04||||0.6063|TWO_SIDED|95.0|-0.189|0.111|||Cochran-Mantel-Haenszel Chi-square Test|||||0.111|-0.189|0.6063
91533335|NCT01950260|182943992|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
91533336|NCT01950260|182943993|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
91533337|NCT01950260|182943994|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
91533338|NCT03283553|182943997|SUPERIORITY|||||||0.264||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.264
91533339|NCT03283553|182943998|SUPERIORITY|||||||0.555||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.555
91755911|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||34.15|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|34.15
91755912|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||58.42|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|58.42
91755913|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||5.93|TWO_SIDED|95.0|0.86|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.86|5.93
91755914|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||35.88|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|35.88
91755915|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||86.41|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.41
91755916|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||13.52|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|13.52
91755917|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||32.84|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|32.84
91755918|NCT02294734|183404487|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||78.09|TWO_SIDED|95.0|0.98|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.98|78.09
91755919|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||60.07|TWO_SIDED|95.0|0.66|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.66|60.07
91755920|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||51.75|TWO_SIDED|95.0|0.65|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.65|51.75
91755921|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||65.66|TWO_SIDED|95.0|0.6|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|0.60|65.66
91533340|NCT03283553|182943999|SUPERIORITY|||||||0.619||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.619
91755922|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||81.67|TWO_SIDED|95.0|0.59|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.59|81.67
91510350|NCT00727857|182892525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.29||||0.0002||95.0|-18.65|-5.93|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.93|-18.65|0.0002
91755923|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||89.98|TWO_SIDED|95.0|0.51|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.51|89.98
91755924|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||43.88|TWO_SIDED|95.0|0.7|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.70|43.88
91755925|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||36.1|TWO_SIDED|95.0|0.64|1.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.91|0.64|36.10
91755926|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.74|TWO_SIDED|95.0|0.47|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.47|95.74
91755927|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.74|TWO_SIDED|95.0|0.67|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.67|50.74
91755928|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||72.81|TWO_SIDED|95.0|0.51|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.51|72.81
91755929|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.73||||94.41|TWO_SIDED|95.0|0.5|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.50|94.41
91755930|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||81.07|TWO_SIDED|95.0|0.55|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.55|81.07
91755931|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||69.29|TWO_SIDED|95.0|0.5|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.50|69.29
91759854|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.42|||||TWO_SIDED|95.0|-11.13|4.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-11.13|
91510351|NCT00727857|182892526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.2069||95.0|-2.93|0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.64|-2.93|0.2069
91510352|NCT00727857|182892526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.0052||95.0|0.73|4.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.15|0.73|0.0052
91510353|NCT00727857|182892526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.59|||<|0.0001||95.0|1.81|5.36|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.36|1.81|<0.0001
91510354|NCT00727857|182892527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.609||95.0|-1.28|0.75|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.75|-1.28|0.6090
91533341|NCT03283553|182944000|SUPERIORITY|||||||0.532||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.532
91533342|NCT03283553|182944001|SUPERIORITY|||||||0.108||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.108
91755932|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||73.67|TWO_SIDED|95.0|0.54|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.54|73.67
91510355|NCT00727857|182892527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6169||95.0|-1.22|0.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.72|-1.22|0.6169
91510356|NCT00727857|182892527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.974||95.0|-0.99|1.03|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.03|-0.99|0.9740
91510357|NCT00727857|182892528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.615||95.0|-3.09|5.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.21|-3.09|0.6150
91510358|NCT00727857|182892528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.2346||95.0|-6.38|1.57|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.57|-6.38|0.2346
91510359|NCT00727857|182892528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.1001||95.0|-7.61|0.67|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.67|-7.61|0.1001
91755933|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||75.82|TWO_SIDED|95.0|0.59|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.59|75.82
91510360|NCT00727857|182892529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86||||0.1217||95.0|-0.76|6.48|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||6.48|-0.76|0.1217
91510361|NCT00727857|182892529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0009||95.0|-9.36|-2.44|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.44|-9.36|0.0009
91510362|NCT00727857|182892529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.76|||<|0.0001||95.0|-12.36|-5.16|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.16|-12.36|<0.0001
91755934|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||54.22|TWO_SIDED|95.0|0.69|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.69|54.22
91755935|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||66.46|TWO_SIDED|95.0|0.63|1.35||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.35|0.63|66.46
91755936|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||21.45|TWO_SIDED|95.0|0.79|1.71||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.71|0.79|21.45
91510363|NCT01469065|182892530|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|84.87|||||TWO_SIDED|90.0|78.16|92.15||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test. Formal statistical inference was not performed thus p value was not reported.||92.15|78.16|
91510364|NCT01469065|182892530|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|89.8|||||TWO_SIDED|90.0|82.69|97.53||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.53|82.69|
91510365|NCT01469065|182892530|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.15|||||TWO_SIDED|90.0|80.27|94.63||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.63|80.27|
91510366|NCT01469065|182892530|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|78.28|||||TWO_SIDED|90.0|72.06|85.03||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||85.03|72.06|
91510367|NCT01469065|182892543|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|82.69|||||TWO_SIDED|90.0|76.06|89.9||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||89.90|76.06|
91510368|NCT01469065|182892543|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.39|||||TWO_SIDED|90.0|78.6|92.77||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.77|78.60|
91510369|NCT01469065|182892543|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.37|||||TWO_SIDED|90.0|78.59|92.76||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.76|78.59|
91510370|NCT01469065|182892543|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|75.82|||||TWO_SIDED|90.0|69.78|82.39||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||82.39|69.78|
91510371|NCT01469065|182892543|SUPERIORITY_OR_OTHER||Difference between Test and Reference|-35.84|||||TWO_SIDED|90.0|-52.89|-18.78||||||Treatment difference and 90% confidence interval (CI) were based on adjusted geometric mean.||-18.78|-52.89|
91510372|NCT01469065|182892544|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|86.72|||||TWO_SIDED|90.0|81.13|92.7||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.70|81.13|
91510373|NCT01469065|182892544|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.13|||||TWO_SIDED|90.0|85.24|97.44||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.44|85.24|
91510374|NCT01469065|182892544|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.05|||||TWO_SIDED|90.0|81.44|93.04||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.04|81.44|
91755937|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||69.91|TWO_SIDED|95.0|0.5|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.50|69.91
91755938|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||75.29|TWO_SIDED|95.0|0.57|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.57|75.29
91510375|NCT01469065|182892544|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|77.95|||||TWO_SIDED|90.0|72.91|83.34||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||83.34|72.91|
91510376|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|100.04|||||TWO_SIDED|90.0|92.7|107.96||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.96|92.70|
91510377|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|99.44|||||TWO_SIDED|90.0|92.04|107.43||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.43|92.04|
91510378|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|101.67|||||TWO_SIDED|90.0|94.1|109.84||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.84|94.10|
91510379|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|96.82|||||TWO_SIDED|90.0|89.69|104.52||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.52|89.69|
91510380|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|95.85|||||TWO_SIDED|90.0|88.82|103.44||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.44|88.82|
91510381|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|98.71|||||TWO_SIDED|90.0|91.37|106.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||106.64|91.37|
91510382|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|99.72|||||TWO_SIDED|90.0|92.3|107.73||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.73|92.30|
91510383|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|94.49|||||TWO_SIDED|90.0|87.53|102.1||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.10|87.53|
91510384|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|93.43|||||TWO_SIDED|90.0|86.5|100.91||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.91|86.50|
91533343|NCT03283553|182944002|SUPERIORITY|||||||0.405||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.405
91533344|NCT03283553|182944003|SUPERIORITY|||||||0.412||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.412
91533345|NCT03283553|182944004|SUPERIORITY|||||||0.872||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.872
91533346|NCT03283553|182944005|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who were registered during the 9-month follow up period.||||||<0.001
91533347|NCT03283553|182944006|SUPERIORITY|||||||0.003|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||0.003
91533348|NCT03283553|182944007|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||<0.001
91533349|NCT03283553|182944008|SUPERIORITY|||||||0.128||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.128
91533350|NCT03283553|182944009|SUPERIORITY|||||||0.247||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.247
91533351|NCT03686683|182944010|SUPERIORITY||Odds Ratio (OR)|1.16||||0.4586|TWO_SIDED|95.0|0.78|1.74|||Cochran-Mantel-Haenszel|||||1.74|0.78|0.4586
91533352|NCT01770860|182944012|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
91533353|NCT01770860|182944013|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
91533354|NCT01770860|182944014|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
91533355|NCT01770860|182944015|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
91533356|NCT01770860|182944016|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect||||||0.0476
91533357|NCT00714233|182944021|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Paired t-test to analyze BMI at baseline and 24 weeks||||<0.05
91755939|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.05|TWO_SIDED|95.0|0.68|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|0.68|44.05
91533358|NCT03432533|182944026|NON_INFERIORITY|Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.84|TWO_SIDED|95.0|-1.3|1.0|||ANCOVA|||||1.0|-1.3|0.84
91533359|NCT00916006|182944042|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91533360|NCT00916006|182944043|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91533361|NCT03419780|182944044|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533362|NCT03419780|182944045|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
91533363|NCT03419780|182944046|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
91533364|NCT03419780|182944047|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
91533365|NCT03419780|182944048|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91533366|NCT03419780|182944049|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91533367|NCT03419780|182944050|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
91533368|NCT01072929|182944058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0097|TWO_SIDED|95.0|-6.58|-0.92||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.92|-6.58|0.0097
91533369|NCT01072929|182944058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0385|TWO_SIDED|95.0|-5.71|-0.16||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.16|-5.71|0.0385
91533370|NCT02806336|182944081|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||change in combined groups||||0.03
91533371|NCT02806336|182944082|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
91533372|NCT02806336|182944083|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
91533373|NCT02806336|182944084|SUPERIORITY|||||||0.03||||||change in functional gait analysis (FGA) in combined groups compared to baseline|t-test, 2 sided|||||||0.03
91533374|NCT02806336|182944085|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91533375|NCT02806336|182944086|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
91533376|NCT02806336|182944086|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
91533377|NCT02806336|182944087|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
91533378|NCT04824131|182944089|OTHER||Exact CI for Proportions|0.0|||||TWO_SIDED|95.0|0.0|6.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|6.7|0|
91533379|NCT04824131|182944090|OTHER||Exact CI for Proportions|61.5|||||TWO_SIDED|95.0|47.0|74.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|74.7|47.0|
91533380|NCT04824131|182944093|OTHER||Exact CI for Proportions|94.3|||||TWO_SIDED|95.0|84.3|98.8|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase|98.8|84.3|
91533381|NCT04824131|182944094|OTHER||Exact CI for Proportions|100.0|||||TWO_SIDED|95.0|93.3|100.0|||||||Exact 95% Confidence Interval for Proportion for Participants who received at least one Injection who Completed All Scheduled Injections|100|93.3|
91533382|NCT04824131|182944095|OTHER||Mean Difference (Final Values)|-0.2728|STANDARD_ERROR_OF_MEAN|0.1704||0.1093|TWO_SIDED|95.0|-0.61|0.06||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|poisson model||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of sexual partners) using a poisson model.||0.06|-0.61|0.1093
91533383|NCT04824131|182944096|OTHER||Mean Difference (Final Values)|-0.5859|STANDARD_ERROR_OF_MEAN|0.2253||0.0093|TWO_SIDED|95.0|-1.03|-0.14||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month|poisson model||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month.|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of episodes of vaginal sex without a condom) using a poisson model.||-0.14|-1.03|0.0093
91533384|NCT04824131|182944096|OTHER||Mean Difference (Final Values)|-0.3087|STANDARD_ERROR_OF_MEAN|1.4036||0.8259|TWO_SIDED|95.0|-3.06|2.44||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Regression, Logistic||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model binary outcomes (any episodes of anal sex without a condom) using a logistic model.||2.44|-3.06|0.8259
91533385|NCT04824131|182944097|OTHER||CI for Incidence rate, exact Poisson|0.0|||||TWO_SIDED|95.0|0.0|10.8|||||Person-years: 34.0||Incidence rate is calculated HIV infections per 100 person years. CI for Incidence rate is calculated using exact Poisson method|10.8|0.0|
91533386|NCT03643965|182944098|OTHER|Ratio of UPCR at 9 months compared to baseline for Nefecon compared to Placebo|Ratio of geometric LS means|0.73||||0.0003|TWO_SIDED|96.0|0.61|0.88|||MMRM model|||||0.88|0.61|0.0003
91533387|NCT03643965|182944099|OTHER|Time-weighted average of eGFR, Nefecon compared to Placebo|Ratio of geometric LS means|1.1|||<|0.0001|TWO_SIDED|95.0|1.06|1.15|||robust regression|||||1.15|1.06|<0.0001
91755940|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||94.93|TWO_SIDED|95.0|0.65|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.65|94.93
91755941|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||97.11|TWO_SIDED|95.0|0.59|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.59|97.11
91755942|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||85.41|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.41
91755943|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||54.73|TWO_SIDED|95.0|0.62|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.62|54.73
91755944|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||72.31|TWO_SIDED|95.0|0.61|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|0.61|72.31
91755945|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||15.05|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|15.05
91755946|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||84.87|TWO_SIDED|95.0|0.68|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.68|84.87
91759855|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.98|||||TWO_SIDED|95.0|-15.7|-0.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.26|-15.70|
91759856|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.17|||||TWO_SIDED|95.0|-12.93|2.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.59|-12.93|
91759857|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.22|||||TWO_SIDED|95.0|-17.9|-2.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.54|-17.90|
91510385|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|92.71|||||TWO_SIDED|90.0|85.81|100.15||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.15|85.81|
91510386|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|94.08|||||TWO_SIDED|90.0|87.08|101.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||101.64|87.08|
91510387|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|87.74|||||TWO_SIDED|90.0|81.2|94.81||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.81|81.20|
91510388|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.91|||||TWO_SIDED|90.0|89.72|104.67||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.67|89.72|
91510389|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.05|||||TWO_SIDED|90.0|88.9|103.76||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.76|88.90|
91510390|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|99.63|||||TWO_SIDED|90.0|92.21|107.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.64|92.21|
91510391|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|94.5|||||TWO_SIDED|90.0|87.46|102.11||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.11|87.46|
91533388|NCT03643965|182944100|OTHER|Ratio of eGFR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0014|TWO_SIDED|95.0|1.03|1.13|||robust regression|||||1.13|1.03|0.0014
91533389|NCT03643965|182944101|OTHER|Ratio of eGFR at 12 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0106|TWO_SIDED|95.0|1.01|1.13|||robust regression|||||1.13|1.01|0.0106
91533390|NCT03643965|182944102|OTHER|Ratio of UACR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|0.69||||0.0005|TWO_SIDED|95.0|0.55|0.86|||MMRM model|||||0.86|0.55|0.0005
91510392|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|86.75|||||TWO_SIDED|90.0|80.32|93.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.69|80.32|
91510393|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|87.87|||||TWO_SIDED|90.0|81.34|94.93||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.93|81.34|
91510394|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|91.35|||||TWO_SIDED|90.0|84.55|98.7||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.70|84.55|
91510395|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|88.6|||||TWO_SIDED|90.0|82.0|95.74||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||95.74|82.00|
91510396|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|83.75|97.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.69|83.75|
91510397|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|84.03|98.08||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.08|84.03|
91510398|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|94.75|||||TWO_SIDED|90.0|87.69|102.34||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.34|87.69|
91510399|NCT01469065|182892545|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|93.18|||||TWO_SIDED|90.0|86.17|100.77||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.77|86.17|
91510400|NCT01469065|182892546|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|112.83|||||TWO_SIDED|90.0|99.84|127.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||127.50|99.84|
91510401|NCT01469065|182892546|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|102.11|||||TWO_SIDED|90.0|90.78|114.85||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||114.85|90.78|
91510402|NCT01469065|182892546|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|111.04|||||TWO_SIDED|90.0|98.5|125.18||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||125.18|98.50|
91510403|NCT01469065|182892546|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.73|||||TWO_SIDED|90.0|85.46|109.48||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.48|85.46|
91510404|NCT01469065|182892547|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|107.13|||||TWO_SIDED|90.0|98.69|116.3||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||116.30|98.69|
91510405|NCT01469065|182892547|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|92.57|||||TWO_SIDED|90.0|85.26|100.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.50|85.26|
91533391|NCT03643965|182944103|OTHER|Time to 30% reduction in eGFR comparison Nefecon to Placebo|Hazard Ratio (HR)|0.45||||0.0028|TWO_SIDED|95.0|0.26|0.75|||Cox proportional hazards model|Cox proportional hazards model with individual patient censoring weighting.||||0.75|0.26|0.0028
91510406|NCT01469065|182892547|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.07|||||TWO_SIDED|90.0|88.51|104.27||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.27|88.51|
91755947|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||92.24|TWO_SIDED|95.0|0.63|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.63|92.24
91759858|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43|||||TWO_SIDED|95.0|-5.32|10.19||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.19|-5.32|
91510407|NCT01469065|182892547|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.7|||||TWO_SIDED|90.0|84.38|99.65||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||99.65|84.38|
91510408|NCT04542070|182892549|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.2|-0.5|
91510409|NCT04542070|182892549|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.2|-0.5|
91510410|NCT04542070|182892550|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.7|||||TWO_SIDED|95.0|-0.6|2.0|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.0|-0.6|
91510411|NCT04542070|182892550|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.7|||||TWO_SIDED|95.0|-0.7|2.0|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.0|-0.7|
91510412|NCT03993938|182892652|OTHER|Delta PVI percentage change and Delta LAP (v-wave) percentage change were correlated using Spearman's rank correlation - two-tailed.|Spearman's rank correlation|0.34||||0.066|TWO_SIDED||||||Spearman's rank correlation|||||||0.066
91510413|NCT03467425|182892668|SUPERIORITY||Odds Ratio (OR)|1.31|||<|0.001|TWO_SIDED|95.0|1.13|1.51||Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.|Regression, Logistic||Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.|||1.51|1.13|<0.001
91510414|NCT03467425|182892669|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0121|<|0.001|TWO_SIDED|95.0|0.026|0.073|||ANCOVA||Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.|||0.073|0.026|<0.001
91510415|NCT03467425|182892670|SUPERIORITY||Odds Ratio (OR)|1.99||||0.103|TWO_SIDED|95.0|0.87|4.53|||Regression, Logistic||Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.|||4.53|0.87|0.103
91510416|NCT00025883|182892671|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within GLD group.||||<0.001
91510417|NCT00025883|182892671|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within PLD group.||||0.004
91533392|NCT03643965|182944104|OTHER|Time to receiving rescue medication comparison Nefecon to Placebo|Hazard Ratio (HR)|0.68||||0.2647|TWO_SIDED|95.0|0.34|1.33|||Cox proportional hazards model|||||1.33|0.34|0.2647
91510418|NCT00025883|182892672|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within GLD group.||||0.05
91510419|NCT00025883|182892672|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within PLD group.||||0.02
91510420|NCT01387607|182892697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1906||0.0001|TWO_SIDED|95.0|-1.1|-0.36||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.36|-1.10|0.0001
91533393|NCT03643965|182944105|OTHER|Ratio of UPCR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.68|||MMRM model|||||0.68|0.51|<0.0001
91510421|NCT01387607|182892698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4376||||0.1397|TWO_SIDED|95.0|0.8732|2.3667||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.||2.3667|0.8732|0.1397
91510422|NCT01387607|182892698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4626||||0.151|TWO_SIDED|95.0|0.8596|2.4886||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.||2.4886|0.8596|0.1510
91510423|NCT01387607|182892699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.6804||0.0762|TWO_SIDED|95.0|-6.3|0.32||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.32|-6.30|0.0762
91510424|NCT01387607|182892700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8924||||0.0044|TWO_SIDED|95.0|1.2007|2.9827||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||2.9827|1.2007|0.0044
91533394|NCT03643965|182944106|OTHER|Ratio of UACR compared to baseline averaged over time points between 12 and 24 months, Nefecon vs Placebo|Ratio of geometric LS means|0.54|||<|0.0001|TWO_SIDED|95.0|0.45|0.63|||MMRM model|||||0.63|0.45|<0.0001
91533395|NCT03643965|182944107|OTHER|Ratio of eGFR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|1.11|||<|0.0001|TWO_SIDED|95.0|1.06|1.16|||robust regression|||||1.16|1.06|<0.0001
91533396|NCT03643965|182944108|OTHER|Proportion of patients without microhematuria, comparison Nefecon vs Placebo|Odds Ratio (OR)|2.5||||0.0001|TWO_SIDED|95.0|1.6|4.1|||Regression, Logistic|||||4.1|1.6|0.0001
91755948|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||63.42|TWO_SIDED|95.0|0.75|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.75|63.42
91755949|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.17||||9.05|TWO_SIDED|95.0|0.93|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.93|9.05
91755950|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||66.4|TWO_SIDED|95.0|0.74|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.74|66.40
91755951|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.78||||97.39|TWO_SIDED|95.0|0.6|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.60|97.39
91755952|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||16.02|TWO_SIDED|95.0|0.89|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.89|16.02
91755953|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||75.69|TWO_SIDED|95.0|0.68|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.68|75.69
91510425|NCT01387607|182892701|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9683||||0.0189|TWO_SIDED|95.0|1.1151|3.4742||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||3.4742|1.1151|0.0189
91510426|NCT01387607|182892702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.427|STANDARD_ERROR_OF_MEAN|2.0152||0.09|TWO_SIDED|95.0|-7.39|0.54||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.54|-7.39|0.0900
91510427|NCT01387607|182892703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.527|STANDARD_ERROR_OF_MEAN|2.1858||0.2485|TWO_SIDED|95.0|-1.77|6.83||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for snoring.||6.83|-1.77|0.2485
91533397|NCT01222247|182944201|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.02|TWO_SIDED|95.0|0.66|0.97|||Chi-squared|||Analysis for Primary Outcome composite||0.97|0.66|0.02
91755954|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||90.22|TWO_SIDED|95.0|0.69|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.69|90.22
91510428|NCT01387607|182892703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.355|STANDARD_ERROR_OF_MEAN|2.265||0.2993|TWO_SIDED|95.0|-6.81|2.1||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for awaken short of breath.||2.10|-6.81|0.2993
91510429|NCT01387607|182892703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.03|STANDARD_ERROR_OF_MEAN|2.4485||0.0003|TWO_SIDED|95.0|4.21|13.85||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for sleep adequacy.||13.85|4.21|0.0003
91510430|NCT01387607|182892704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.1114||0.0106|TWO_SIDED|95.0|0.07|0.51||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for quantity of sleep.||0.51|0.07|0.0106
91510431|NCT01387607|182892704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.194|STANDARD_ERROR_OF_MEAN|1.6428||0.0112|TWO_SIDED|95.0|0.96|7.43||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for somnolence||7.43|0.96|0.0112
91510432|NCT01387607|182892705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.059|STANDARD_ERROR_OF_MEAN|1.6438||0.0637|TWO_SIDED|95.0|-6.29|0.18||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.18|-6.29|0.0637
91510433|NCT01387607|182892706|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6767|TWO_SIDED|95.0|0.67|1.87||Logistic regression model includes treatment and pooled center as factors and baseline value as covariate.|Regression, Logistic|||||1.87|0.67|0.6767
91510434|NCT01387607|182892707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.882|STANDARD_ERROR_OF_MEAN|0.1932|<|0.0001|TWO_SIDED|95.0|-1.26|-0.5||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.50|-1.26|<0.0001
91510435|NCT01387607|182892708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.172|STANDARD_ERROR_OF_MEAN|7.7785||0.0273|TWO_SIDED|95.0|-32.42|-1.92||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-1.92|-32.42|0.0273
91510436|NCT01387607|182892709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0677||0.8082|TWO_SIDED|95.0|-0.12|0.15||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||0.15|-0.12|0.8082
91510437|NCT01387607|182892710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.655|STANDARD_ERROR_OF_MEAN|0.1223|<|0.0001|TWO_SIDED|95.0|-0.89|-0.41||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.41|-0.89|<0.0001
91510438|NCT01387607|182892711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.396|STANDARD_ERROR_OF_MEAN|7.7309||0.3388|TWO_SIDED|95.0|-7.76|22.55||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||22.55|-7.76|0.3388
91510439|NCT01387607|182892712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.765|STANDARD_ERROR_OF_MEAN|0.2115||0.0003|TWO_SIDED|95.0|0.35|1.18||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||1.18|0.35|0.0003
91510440|NCT01387607|182892713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.8414||0.3186|TWO_SIDED|95.0|-2.5|0.82||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.82|-2.50|0.3186
91510441|NCT01387607|182892714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.0404||0.7149|TWO_SIDED|95.0|-1.67|2.43||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.43|-1.67|0.7149
91510442|NCT01387607|182892715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|0.673||0.2442|TWO_SIDED|95.0|-0.54|2.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.11|-0.54|0.2442
91510443|NCT01387607|182892716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.616|STANDARD_ERROR_OF_MEAN|2.4019||0.1332|TWO_SIDED|95.0|-8.34|1.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||1.11|-8.34|0.1332
91510444|NCT01387607|182892717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.3595||0.2934||95.0|-1.09|0.33||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.33|-1.09|0.2934
91533398|NCT01222247|182944201|SUPERIORITY||Risk Ratio (RR)|0.77||||0.01|TWO_SIDED|95.0|0.63|0.95|||Chi-squared|||Analysis for CPAP or high-flow nasal cannula||0.95|0.63|0.01
91510445|NCT01387607|182892718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.3621||0.0226|TWO_SIDED|95.0|-1.54|-0.12||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||-0.12|-1.54|0.0226
91755955|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||9.64|TWO_SIDED|95.0|0.91|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|0.91|9.64
91755956|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||20.44|TWO_SIDED|95.0|0.82|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.82|20.44
91755957|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.06|TWO_SIDED|95.0|0.73|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.73|55.06
91755958|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.36||||5.29|TWO_SIDED|95.0|0.94|1.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.97|0.94|5.29
91755959|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||28.82|TWO_SIDED|95.0|0.77|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.77|28.82
91755960|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||93|TWO_SIDED|95.0|0.61|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.61|93.00
91755961|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||1.64|TWO_SIDED|95.0|1.03|1.95||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.95|1.03|1.64
91755962|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.71|TWO_SIDED|95.0|0.72|1.38||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.38|0.72|50.71
91510446|NCT00827372|182892746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0658|||||||t-test, 2 sided|||With a sample size of 14 evaluable subjects, we will have 80% power to detect a change in excess arm volume of .8 standard deviations using a two-sided paired t-test. We will have 90% power to detect a difference of .9 standard deviations. A Paired T-Test was used to test the difference in arm volume from the second baseline measurement to Cycle 2 only.||||0.0658
91510447|NCT00827372|182892747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||t-test, 2 sided|||A Paired T-Test was used to compare the IFP affected at first versus affected at last reading.||||0.0061
91755963|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.68||||99.52|TWO_SIDED|95.0|0.51|0.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.91|0.51|99.52
91759859|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.14|||||TWO_SIDED|95.0|-18.83|-3.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.45|-18.83|
91510448|NCT00827372|182892748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0143|||||||t-test, 2 sided|||A Paired T-Test was used for the difference in the impedance ratio from the second baseline to cycle 2, day 1||||0.0143
91533399|NCT01222247|182944201|SUPERIORITY||Risk Ratio (RR)|0.77||||0.17|TWO_SIDED|95.0|0.53|1.12|||Chi-squared|||Analysis for Fraction of inspired oxygen||1.12|0.53|0.17
91533400|NCT01222247|182944201|SUPERIORITY||Risk Ratio (RR)|0.78||||0.26|TWO_SIDED|95.0|0.5|1.21|||Chi-squared|||Analysis for mechanical ventilation||1.21|0.50|0.26
91533401|NCT01222247|182944202|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.53|0.84|||Chi-squared|||||0.84|0.53|<0.001
91533402|NCT01222247|182944203|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.003|TWO_SIDED|95.0|0.66|0.92|||Chi-squared|||||0.92|0.66|0.003
91533403|NCT01222247|182944204|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.65|1.17|||Chi-squared|||||1.17|0.65|0.36
91755964|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.1|TWO_SIDED|95.0|0.99|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.99|3.10
91755965|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||75.39|TWO_SIDED|95.0|0.71|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.71|75.39
91755966|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||93.29|TWO_SIDED|95.0|0.68|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.68|93.29
91755967|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.33||||3.79|TWO_SIDED|95.0|0.97|1.82||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.82|0.97|3.79
91755968|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||36.75|TWO_SIDED|95.0|0.76|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.76|36.75
91755969|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.72||||99.32|TWO_SIDED|95.0|0.56|0.93||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.93|0.56|99.32
91755970|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||18.91|TWO_SIDED|95.0|0.93|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.93|18.91
91755971|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.35|TWO_SIDED|95.0|0.87|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.87|47.35
91533404|NCT01222247|182944205|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.68||||0.002|TWO_SIDED|95.0|0.53|0.87|||Chi-squared|||||0.87|0.53|0.002
91755972|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||78|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|78.00
91755973|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||2.65|TWO_SIDED|95.0|1.0|1.67||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.67|1.00|2.65
91533405|NCT01222247|182944206|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.57|TWO_SIDED|95.0|0.55|1.39|||Chi-squared|||||1.39|0.55|0.57
91533406|NCT01222247|182944207|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.22||||0.04|TWO_SIDED|95.0|0.02|0.92|||Chi-squared|||||0.92|0.02|0.04
91533407|NCT01222247|182944208|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.45||||0.1|TWO_SIDED|95.0|0.17|1.19|||Chi-squared|||||1.19|0.17|0.10
91755974|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||58.48|TWO_SIDED|95.0|0.73|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.73|58.48
91510449|NCT02033889|182892770|SUPERIORITY||Difference in Least Squares Means|-0.88|||<|0.001|TWO_SIDED|95.0|-1.05|-0.71|||Constrained Longitudinal Data Analysis||||Based on Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.71|-1.05|<0.001
91510450|NCT02033889|182892770|SUPERIORITY||Difference in Least Squares Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.87|-0.53|||Constrained Longitudinal Data Analysis||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.53|-0.87|<0.001
91510451|NCT02033889|182892772|OTHER||Difference in % vs Placebo/Glimepiride|1.5|||||TWO_SIDED|95.0|-2.1|5.4|||||||Miettinen \& Nurminen method was used to construct the 95% CI|5.4|-2.1|
91510452|NCT02033889|182892772|OTHER||Difference in % vs Placebo/Glimepiride|1.0|||||TWO_SIDED|95.0|-2.5|4.7|||||||Miettinen \& Nurminen method was used to construct the 95% CI|4.7|-2.5|
91510453|NCT02033889|182892773|SUPERIORITY||Difference in Least Squares Means|-38.25|||<|0.001|TWO_SIDED|95.0|-44.5|-31.99|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-31.99|-44.50|<0.001
91510454|NCT02033889|182892773|SUPERIORITY||Difference in the Least Squares Means|-26.69|||<|0.001|TWO_SIDED|95.0|-32.9|-20.48|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-20.48|-32.90|<0.001
91510455|NCT02033889|182892774|SUPERIORITY||Difference in Least Squares Means|-1.6|||<|0.001|TWO_SIDED|95.0|-2.16|-1.03|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.03|-2.16|<0.001
91510456|NCT02033889|182892774|SUPERIORITY||Difference in Least Squares Means|-1.67|||<|0.001|TWO_SIDED|95.0|-2.24|-1.11|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.11|-2.24|<0.001
91510457|NCT02033889|182892775|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|4.48|||<|0.001|TWO_SIDED|95.0|2.64|7.62|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|7.62|2.64|<0.001
91510458|NCT02033889|182892775|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|3.03|||<|0.001|TWO_SIDED|95.0|1.81|5.06|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|5.06|1.81|<0.001
91510459|NCT02033889|182892776|SUPERIORITY||Difference in Least Squares Means|-4.5|||<|0.001|TWO_SIDED|95.0|-6.81|-2.19|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-2.19|-6.81|<0.001
91510460|NCT02033889|182892776|SUPERIORITY||Difference in Least Squares Means|-3.68||||0.002|TWO_SIDED|95.0|-5.96|-1.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-1.39|-5.96|0.002
91533408|NCT01222247|182944209|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.59||||0.03|TWO_SIDED|95.0|0.37|0.96|||Chi-squared|||||0.96|0.37|0.03
91510461|NCT02033889|182892777|SUPERIORITY||Difference in Least Squares Means|-2.42||||0.001|TWO_SIDED|95.0|-3.86|-0.98|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.98|-3.86|0.001
91510462|NCT02033889|182892777|SUPERIORITY||Difference in Least Squares Means|-1.82||||0.013|TWO_SIDED|95.0|-3.24|-0.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.39|-3.24|0.013
91533409|NCT01222247|182944210|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.004|TWO_SIDED|95.0|0.66|0.93|||Chi-squared|||||0.93|0.66|0.004
91533410|NCT01222247|182944211|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82||||0.74|TWO_SIDED|95.0|0.25|2.68|||Chi-squared|||||2.68|0.25|0.74
91533411|NCT01222247|182944212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Chi-squared|||||||0.50
91533412|NCT01222247|182944213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91533413|NCT01222247|182944214|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.13|TWO_SIDED|95.0|0.96|1.34|||Chi-squared|||||1.34|0.96|0.13
91755975|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||99.64|TWO_SIDED|95.0|0.61|0.92||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.92|0.61|99.64
91755976|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||1.9|TWO_SIDED|95.0|1.01|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|1.01|1.90
91755977|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||63.03|TWO_SIDED|95.0|0.81|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.81|63.03
91755978|NCT02294734|183404488|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||99.19|TWO_SIDED|95.0|0.72|0.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.97|0.72|99.19
91755979|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||67.19|TWO_SIDED|95.0|0.64|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.64|67.19
91755980|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.8|TWO_SIDED|95.0|0.66|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.66|44.80
91755981|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||59.9|TWO_SIDED|95.0|0.61|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.61|59.90
91755982|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||70.12|TWO_SIDED|95.0|0.63|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.63|70.12
91755983|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||83.98|TWO_SIDED|95.0|0.54|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.54|83.98
91533414|NCT01222247|182944215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Chi-squared|||||||0.10
91533415|NCT01222247|182944217|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.93|||Chi-squared|||||1.93|0.33|0.62
91755984|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||34.93|TWO_SIDED|95.0|0.73|1.57||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.57|0.73|34.93
91755985|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||32.45|TWO_SIDED|95.0|0.65|1.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.96|0.65|32.45
91759860|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.42|||||TWO_SIDED|95.0|-12.44|1.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.59|-12.44|
91755986|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.35|TWO_SIDED|95.0|0.46|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.46|95.35
91755987|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.1|TWO_SIDED|95.0|0.66|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.66|50.10
91533416|NCT01222247|182944219|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Chi-squared|||||1.18|0.66|0.40
91533417|NCT01222247|182944220|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.6|||<|0.001|TWO_SIDED|95.0|1.37|1.87|||Chi-squared|||||1.87|1.37|<0.001
91533418|NCT01222247|182944221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91533419|NCT01222247|182944222|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.4|TWO_SIDED|95.0|0.78|1.1|||Chi-squared|||||1.10|0.78|0.40
91533420|NCT01222247|182944223|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.4|||Chi-squared|||||1.40|0.95|0.15
91533421|NCT01222247|182944224|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16||||0.24|TWO_SIDED|95.0|0.91|1.47|||Chi-squared|||||1.47|0.91|0.24
91533422|NCT01222247|182944225|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.09|TWO_SIDED|95.0|0.85|1.01|||Chi-squared|||Analysis for NICU stay of any duration||1.01|0.85|0.09
91533423|NCT01222247|182944225|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.98|||Chi-squared|||Analysis for duration greater than or equal to 3 days||0.98|0.80|0.03
91533424|NCT01222247|182944226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
91533425|NCT01222247|182944227|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.61||||0.08|TWO_SIDED|95.0|0.35|1.07|||Chi-squared|||Statistical analysis for chorioamnionitis||1.07|0.35|0.08
91533426|NCT01222247|182944227|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.96|TWO_SIDED|95.0|0.49|1.95|||Chi-squared|||Analysis for Postpartum Endometritis||1.95|0.49|0.96
91533427|NCT01222247|182944227|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.15|||Chi-squared|||Statistical analysis for cesarean delivery||1.15|0.93|0.56
91533428|NCT01222247|182944228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Analysis for interval from randomization to delivery||||0.57
91533429|NCT01222247|182944229|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91533430|NCT04736056|182944246|OTHER||Cohen's d effect size|1.2|||||TWO_SIDED|95.0|0.73|1.66||||||0 to 12 weeks||1.66|0.73|
91533431|NCT04736056|182944246|OTHER||Cohen's d effect size|1.07|||||TWO_SIDED|95.0|0.61|1.51||||||0 to 16 weeks||1.51|0.61|
91533432|NCT04736056|182944247|OTHER||Cohen's d effect size|0.35|||||TWO_SIDED|95.0|-0.02|0.71||||||0 to 12 weeks||0.71|-0.02|
91533433|NCT04736056|182944247|OTHER||Cohen's d effect size|0.25|||||TWO_SIDED|95.0|-0.12|0.61||||||0 to 16 weeks||0.61|-0.12|
91533434|NCT04736056|182944248|OTHER||Cohen's d effect size|0.78|||||TWO_SIDED|95.0|0.38|1.18||||||0 to 12 weeks||1.18|0.38|
91533435|NCT04736056|182944248|OTHER||Cohen's d effect size|0.5|||||TWO_SIDED|95.0|0.11|0.87||||||0 to 16 weeks||0.87|0.11|
91533436|NCT04736056|182944249|OTHER||Cohen's d effect size|0.23|||||TWO_SIDED|95.0|-0.13|0.58||||||0 to 12 weeks||0.58|-0.13|
91533437|NCT04736056|182944249|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.05|0.68||||||0 to 16 weeks||0.68|-0.05|
91533438|NCT04736056|182944250|OTHER||Cohen's d effect size|0.32|||||TWO_SIDED|95.0|-0.04|0.68||||||0 to 12 weeks||0.68|-0.04|
91533439|NCT04736056|182944250|OTHER||Cohen's d effect size|0.61|||||TWO_SIDED|95.0|0.22|1.0||||||0 to 16 weeks||1.00|0.22|
91533440|NCT04736056|182944251|OTHER||Cohen's d effect size|0.38|||||TWO_SIDED|95.0|0.01|0.74||||||0 to 12 weeks||0.74|0.01|
91533441|NCT04736056|182944251|OTHER||Cohen's d effect size|0.47|||||TWO_SIDED|95.0|0.09|0.85||||||0 to 16 weeks||0.85|0.09|
91533442|NCT04736056|182944252|OTHER||Cohen's d effect size|0.29|||||TWO_SIDED|95.0|-0.07|0.65||||||0 to 12 weeks||0.65|-0.07|
91533443|NCT04736056|182944252|OTHER||Cohen's d effect size|0.6|||||TWO_SIDED|95.0|0.21|0.99||||||||0.99|0.21|
91533444|NCT04736056|182944253|OTHER||Cohen's d effect size|0.54|||||TWO_SIDED|95.0|0.16|0.91||||||0 to 12 weeks||0.91|0.16|
91533445|NCT04736056|182944253|OTHER||Cohen's d effect size|0.51|||||TWO_SIDED|95.0|0.12|0.89||||||0 to 16 weeks||0.89|0.12|
91533446|NCT04736056|182944254|OTHER||Cohen's d effect size|0.89|||||TWO_SIDED|95.0|0.47|1.3||||||0 to 12 weeks||1.30|0.47|
91533447|NCT04736056|182944254|OTHER||Cohen's d effect size|0.66|||||TWO_SIDED|95.0|0.26|1.05||||||0 to 16 weeks||1.05|0.26|
91533448|NCT04736056|182944255|OTHER||Cohen's d effect size|-0.4|||||TWO_SIDED|95.0|-0.76|-0.03||||||0 to 12 weeks||-0.03|-0.76|
91533449|NCT04736056|182944255|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.71|0.03||||||0 to 16 weeks||0.03|-0.71|
91533450|NCT04736056|182944256|OTHER||Cohen's d effect size|0.0|||||TWO_SIDED|95.0|-0.35|0.35||||||0 to 12 weeks||0.35|-0.35|
91533451|NCT04736056|182944256|OTHER||Cohen's d effect size|-0.28|||||TWO_SIDED|95.0|-0.64|0.09||||||0 to 16 weeks||0.09|-0.64|
91533452|NCT04736056|182944257|OTHER||Cohen's d effect size|0.1|||||TWO_SIDED|95.0|-0.45|0.26||||||||0.26|-0.45|
91533453|NCT04736056|182944257|OTHER||Cohen's d effect size|0.09|||||TWO_SIDED|95.0|-0.27|0.45||||||0 to 16 weeks||0.45|-0.27|
91533454|NCT04736056|182944258|OTHER||Cohen's d effect size|-0.035|||||TWO_SIDED|95.0|-0.71|0.01||||||0 to 12 weeks||0.01|-0.71|
91533455|NCT04736056|182944258|OTHER||Cohen's d effect size|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||0 to 16 weeks||0.08|-0.65|
91533456|NCT04736056|182944259|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.7|0.03||||||0 to 12 weeks||0.03|-0.70|
91759861|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.24|||||TWO_SIDED|95.0|-19.27|-5.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.20|-19.27|
91755988|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||59.37|TWO_SIDED|95.0|0.55|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.55|59.37
91513433|NCT01242527|182898611|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.19||||0.007|TWO_SIDED|95.0|-40.32|-2.29||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-2.29|-40.32|0.007
91513434|NCT01242527|182898611|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-26.6|||<|0.001|TWO_SIDED|95.0|-45.12|-8.38||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-8.38|-45.12|<0.001
91513435|NCT02127307|182898666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446|||<|0.0001|TWO_SIDED|95.0|0.3227|0.6156||At 0.025 level of significance.|Cox proportional hazards model|||"AdreView-Heart Failure Group with H/M \<1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time t was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.6156|0.3227|<0.0001
91513436|NCT00983580|182898670|SUPERIORITY|||||||0.448|||||||Chi-squared|||||||0.448
91513437|NCT00983580|182898671|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||This statistical analysis compares the difference between the number of patients with No adenoma recurrence at 12 months with those with adenoma recurrence at 12 months.||||0.358
91513438|NCT00983580|182898673|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||||||0.513
91513439|NCT04286594|182898692|OTHER|Change in single group over time|Mean Difference (Final Values)|11.667|STANDARD_DEVIATION|5.051|<|0.001|TWO_SIDED|95.0|8.457|14.876|||t-test, 1 sided|||||14.876|8.457|<0.001
91513440|NCT05955560|182898716|SUPERIORITY|||||||0.04||||||A two-sided paired t-test was used and p-value derived. The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||||0.04
91513441|NCT04621500|182898721|OTHER|The sequencing transcriptional profile cannot be analyzed by a statistical method.|||||||||||||||||In this open label study, the RNA sequencing transcription analysis was performed to assess if the transcriptome would be modified by vitamin D supplementation and it uniformaly was.|||
91513442|NCT00982020|182898752|SUPERIORITY_OR_OTHER|||||||0.15||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group\*visit.||||||0.150
91513443|NCT00982020|182898753|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.||||||0.520
91513444|NCT00982020|182898755|SUPERIORITY_OR_OTHER|||||||0.008||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.008
91513445|NCT00982020|182898756|SUPERIORITY_OR_OTHER|||||||0.266||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included intervention group, visit, region, and intervention group\*visit.||||||0.266
91513446|NCT00982020|182898757|SUPERIORITY_OR_OTHER|||||||0.954||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group\*visit.||||||0.954
91513447|NCT00982020|182898758|SUPERIORITY_OR_OTHER|||||||0.103||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.103
91513448|NCT00982020|182898759|SUPERIORITY_OR_OTHER|||||||0.436||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.436
91513449|NCT01762761|182898760|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|26.08|||<|0.001|TWO_SIDED|95.0|7.29|93.26|||Regression, Logistic|||||93.26|7.29|<0.001
91513450|NCT01762761|182898761|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.8|||<|0.001|TWO_SIDED|95.0|8.54|66.33|||Regression, Logistic|||||66.33|8.54|<0.001
91513451|NCT01762761|182898762|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.52|||<|0.001|TWO_SIDED|95.0|3.84|18.94|||Regression, Logistic|||||18.94|3.84|<0.001
91533457|NCT04736056|182944259|OTHER||Cohen's d effect size|-0.47|||||TWO_SIDED|95.0|-0.85|-0.09||||||0 to 16 weeks||-0.09|-0.85|
91513452|NCT01762761|182898763|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.001|TWO_SIDED|95.0|0.13|0.59|||Mixed Models Analysis|||||0.59|0.13|0.001
91513453|NCT01762761|182898764|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59||||0.306|TWO_SIDED|95.0|0.21|1.64|||Mixed Models Analysis|||||1.64|0.21|0.306
91513454|NCT01762761|182898765|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.12|||<|0.001|TWO_SIDED|95.0|4.01|9.34|||Log Rank|||||9.34|4.01|<0.001
91513455|NCT01762761|182898766|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.05|0.37|||Regression, Logistic|||||0.37|0.05|<0.001
91513456|NCT01762761|182898767|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|16.54||||0.008|TWO_SIDED|95.0|2.09|131.12|||Regression, Logistic|||||131.12|2.09|0.008
91513457|NCT01762761|182898768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
91513458|NCT01762761|182898769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
91513459|NCT01485861|182898846|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.77||||0.1606|TWO_SIDED|90.0|0.56|1.04|||Log Rank|||||1.04|0.56|0.1606
91513460|NCT01485861|182898846|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.89||||0.53|TWO_SIDED|90.0|0.66|1.2|||Log Rank|||||1.20|0.66|0.5300
91513461|NCT01485861|182898846|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen \[PSA\] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.75||||0.1689|TWO_SIDED|90.0|0.54|1.05|||Log Rank|||||1.05|0.54|0.1689
91513462|NCT01485861|182898846|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.94||||0.7484|TWO_SIDED|90.0|0.69|1.28|||Log Rank|||||1.28|0.69|0.7484
91513463|NCT01485861|182898847|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.39||||0.0064|TWO_SIDED|90.0|0.22|0.7|||Log Rank|||||0.70|0.22|0.0064
91513464|NCT01485861|182898847|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.46||||0.0285|TWO_SIDED|90.0|0.25|0.83|||Log Rank|||||0.83|0.25|0.0285
91513465|NCT01485861|182898865|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.87||||0.417|TWO_SIDED|95.0|0.62|1.22|||Log Rank|||||1.22|0.62|0.4170
91513466|NCT01485861|182898865|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.93||||0.6712|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.6712
91513467|NCT01485861|182898865|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5164|TWO_SIDED|95.0|0.62|1.27|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.27|0.62|0.5164
91513468|NCT01485861|182898865|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8955|TWO_SIDED|95.0|0.72|1.44|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.44|0.72|0.8955
91513469|NCT01485861|182898866|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.63||||0.1472|TWO_SIDED|95.0|0.33|1.19|||Log Rank|||||1.19|0.33|0.1472
91513470|NCT01485861|182898866|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.45||||0.0157|TWO_SIDED|95.0|0.23|0.87|||Log Rank|||||0.87|0.23|0.0157
91513471|NCT01485861|182898869|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.0665|TWO_SIDED|90.0|0.51|0.97|||Log Rank|||||0.97|0.51|= 0.0665
91513472|NCT01485861|182898869|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.9319|TWO_SIDED|90.0|0.73|1.33|||Log Rank|||||1.33|0.73|= 0.9319
91513473|NCT01485861|182898869|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.071|TWO_SIDED|90.0|0.5|0.97|||Log Rank|||Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||0.97|0.50|= 0.0710
91513474|NCT01485861|182898869|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.789|TWO_SIDED|90.0|0.7|1.31|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.31|0.70|= 0.7890
91513475|NCT01485861|182898870|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.2906|TWO_SIDED|90.0|0.37|1.25|||Log Rank|||||1.25|0.37|= 0.2906
91513476|NCT01485861|182898870|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.2716|TWO_SIDED|90.0|0.35|1.22|||Log Rank|||||1.22|0.35|= 0.2716
91513477|NCT01485861|182898871|SUPERIORITY|Unstratified|Difference in response rates|1.97|||=|0.7913|TWO_SIDED|90.0|-10.25|14.18|||Chi-squared|||||14.18|-10.25|= 0.7913
91513478|NCT01485861|182898871|SUPERIORITY|Unstratified|Difference in response rates|-1.22|||=|0.8675|TWO_SIDED|90.0|-13.24|10.8|||Chi-squared|||||10.80|-13.24|= 0.8675
91513479|NCT01485861|182898872|SUPERIORITY||Difference in response rates|11.43|||=|0.4176|TWO_SIDED|90.0|-11.43|58.32|||Chi-squared|||||58.32|-11.43|= 0.4176
91513480|NCT01485861|182898872|SUPERIORITY||Difference in response rates|15.43|||=|0.2802|TWO_SIDED|90.0|-7.58|38.44|||Chi-squared|||||38.44|-7.58|= 0.2802
91513481|NCT01485861|182898873|SUPERIORITY||Difference in response rates|9.58|||=|0.3646|TWO_SIDED|90.0|-7.65|26.8|||Chi-squared|||||26.80|-7.65|= 0.3646
91513482|NCT01485861|182898873|SUPERIORITY||Difference in response rates|0.22|||=|0.9821|TWO_SIDED|90.0|-15.89|16.33|||Chi-squared|||||16.33|-15.89|= 0.9821
91513483|NCT01485861|182898874|SUPERIORITY||Difference in response rates|-3.17|||=|0.8489|TWO_SIDED|90.0|-30.93|24.58|||Chi-squared|||||24.58|-30.93|= 0.8489
91513484|NCT01485861|182898874|SUPERIORITY||Difference in response rates|12.38|||=|0.5186|TWO_SIDED|90.0|-16.36|41.12|||Chi-squared|||||41.12|-16.36|= 0.5186
91513485|NCT01485861|182898875|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.31|||=|0.678|TWO_SIDED|90.0|0.45|3.8|||Log Rank|||||3.80|0.45|= 0.6780
91513486|NCT01485861|182898875|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.85|||=|0.8372|TWO_SIDED|90.0|0.24|3.02|||Log Rank|||||3.02|0.24|= 0.8372
91513487|NCT01485861|182898875|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.7733|TWO_SIDED|90.0|0.17|3.5|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||3.50|0.17|= 0.7733
91513488|NCT01485861|182898875|SUPERIORITY||Hazard Ratio (HR)|2.46|||=|0.4227|TWO_SIDED|90.0|0.36|16.59|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||16.59|0.36|= 0.4227
91755989|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.8||||87.99|TWO_SIDED|95.0|0.55|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.55|87.99
91513489|NCT01485861|182898876|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.3173|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.3173
91513490|NCT01485861|182898876|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.6171|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.6171
91513491|NCT01485861|182898877|SUPERIORITY||Difference in response rates|3.75|||=|0.6652|TWO_SIDED|90.0|-10.47|17.97|||Chi-squared|||||17.97|-10.47|= 0.6652
91513492|NCT01485861|182898877|SUPERIORITY||Difference in response rates|7.48|||=|0.3734|TWO_SIDED|90.0|-6.29|21.24|||Chi-squared|||||21.24|-6.29|= 0.3734
91513493|NCT01485861|182898878|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
91513494|NCT01485861|182898878|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
91513495|NCT01485861|182898879|SUPERIORITY||Difference in response rates|2.24|||=|0.8317|TWO_SIDED|90.0|-15.07|19.54|||Chi-squared|||||19.54|-15.07|= 0.8317
91513496|NCT01485861|182898879|SUPERIORITY||Difference in response rates|5.14|||=|0.6139|TWO_SIDED|90.0|-11.6|21.88|||Chi-squared|||||21.88|-11.60|= 0.6139
91513497|NCT01485861|182898880|SUPERIORITY||Difference in response rates|34.85|||=|0.0505|TWO_SIDED|90.0|7.14|62.56|||Chi-squared|||||62.56|7.14|= 0.0505
91513498|NCT01485861|182898880|SUPERIORITY||Difference in response rates|-9.6|||=|0.4989|TWO_SIDED|90.0|-32.54|13.35|||Chi-squared|||||13.35|-32.54|= 0.4989
91513499|NCT01485861|182898883|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.95|||=|0.8483|TWO_SIDED|90.0|0.61|1.47|||Log Rank|||||1.47|0.61|= 0.8483
91513500|NCT01485861|182898883|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.08|||=|0.785|TWO_SIDED|90.0|0.7|1.65|||Log Rank|||||1.65|0.70|= 0.7850
91513501|NCT01485861|182898883|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.8847|TWO_SIDED|90.0|0.66|1.65|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.65|0.66|= 0.8847
91513502|NCT01485861|182898883|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.8647|TWO_SIDED|90.0|0.67|1.63|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.63|0.67|= 0.8647
91513503|NCT01485861|182898884|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.8271|TWO_SIDED|90.0|0.39|2.06|||Log Rank|||||2.06|0.39|= 0.8271
91513504|NCT01485861|182898884|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.7383|TWO_SIDED|90.0|0.35|2.02|||Log Rank|||||2.02|0.35|= 0.7383
91513505|NCT01243944|182898935|SUPERIORITY_OR_OTHER||Odds Ratio, log|32.67|||<|0.0001|TWO_SIDED|95.0|5.04|1337.0|||Exact Cochran-Mantel-Haenszel|||||1337|5.04|< 0.0001
91513506|NCT01243944|182898936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.01|||<|0.0001|TWO_SIDED|95.0|4.24|1144.0|||Exact Cochran-Mantel-Haenszel|||||1144|4.24|<0.0001
91513507|NCT01243944|182898937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.57||||0.0016|TWO_SIDED|95.0|1.5|9.06|||Exact Cochran-Mantel-Haenszel|P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.||||9.06|1.50|0.0016
91513508|NCT03029208|182898957|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.1|||||TWO_SIDED|95.0|-0.34|0.14|||||An ANCOVA model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95% CI for the treatment difference (daprodustat-darbepoetin alfa).|||0.14|-0.34|
91513509|NCT03029208|182898958|SUPERIORITY||LS mean difference|19.4||||0.8949|TWO_SIDED|95.0|-11.0|49.9|||ANCOVA||An ANCOVA model was used to compare the difference in this average monthly IV iron dose between arms, including factors for Baseline dose, treatment and the randomization stratification factors.|||49.9|-11.0|0.8949
91513510|NCT03029208|182898959|SUPERIORITY||LS mean difference|3.23||||0.8168|TWO_SIDED|95.0|-3.82|10.27|||Mixed model repeated measures (MMRM)||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||10.27|-3.82|0.8168
91513511|NCT03029208|182898959|SUPERIORITY||LS mean difference|4.21||||0.9793|TWO_SIDED|95.0|0.17|8.26|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.26|0.17|0.9793
91513512|NCT03029208|182898959|SUPERIORITY||LS mean difference|4.1||||0.9597|TWO_SIDED|95.0|-0.51|8.7|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.70|-0.51|0.9597
91513513|NCT03029208|182898960|SUPERIORITY||LS mean difference|-0.09||||0.484|TWO_SIDED|95.0|-4.72|4.53|||ANCOVA||The difference in change from Baseline in SBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.53|-4.72|0.4840
91513514|NCT03029208|182898960|SUPERIORITY||LS mean difference|1.99||||0.9156|TWO_SIDED|95.0|-0.85|4.82|||ANCOVA||The difference in change from Baseline in DBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.82|-0.85|0.9156
91513515|NCT03029208|182898960|SUPERIORITY||LS mean difference|1.29||||0.7966|TWO_SIDED|95.0|-1.76|4.33|||ANCOVA||The difference in change from Baseline in MAP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.33|-1.76|0.7966
91533458|NCT04529538|182944268|OTHER||GMT Ratio|0.68|||||TWO_SIDED|95.0|0.252|1.838|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of Type 1 neutralizing antibody GMT at Day 29||1.838|0.252|
91533459|NCT04529538|182944269|OTHER||GMT Ratio|1.26|||||TWO_SIDED|95.0|0.232|6.833|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 29||6.833|0.232|
91533460|NCT04529538|182944269|OTHER||GMT Ratio|1.98|||||TWO_SIDED|95.0|0.603|6.528|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 57||6.528|0.603|
91533461|NCT04529538|182944270|OTHER||GMT Ratio|1.56|||||TWO_SIDED|95.0|0.639|3.828|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||3.828|0.639|
91533462|NCT04529538|182944271|OTHER||GMT Ratio|1.79|||||TWO_SIDED|95.0|0.772|4.163|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||4.163|0.772|
91533463|NCT04529538|182944271|OTHER||GMT Ratio|2.51|||||TWO_SIDED|95.0|0.994|6.34|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 57||6.340|0.994|
91533464|NCT04529538|182944272|OTHER||Rate Difference|-4.0|||>|0.999|TWO_SIDED|95.0|-27.67|22.72|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-Group Seroconversion Rate (4-fold rise) in Neutralizing Antibody Titers||22.72|-27.67|>0.999
91533465|NCT04529538|182944273|OTHER||Rate Difference|-2.8|||>|0.999|TWO_SIDED|95.0|-20.47|20.86|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||20.86|-20.47|>0.999
91533466|NCT04529538|182944273|OTHER||Rate Difference|8.3||||0.263|TWO_SIDED|95.0|-5.71|30.57|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||30.57|-5.71|0.263
91533467|NCT04529538|182944274|OTHER||Rate Difference|14.3||||0.224|TWO_SIDED|95.0|-8.3|40.45|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after vaccination||40.45|-8.30|0.224
91533468|NCT04529538|182944275|OTHER||Rate Difference|9.8||||0.275|TWO_SIDED|95.0|-7.29|35.19|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||35.19|-7.29|0.275
91533469|NCT04529538|182944275|OTHER||Rate Difference|17.9||||0.1|TWO_SIDED|95.0|-1.27|44.93|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||44.93|-1.27|0.100
91533470|NCT05302791|182944306|SUPERIORITY|||||||0.609|||||||ANOVA|time x condition ANOVA||||||.609
91533471|NCT05302791|182944307|SUPERIORITY|||||||0.858|||||||ANOVA|time x condition anova||||||.858
91533472|NCT05302791|182944308|SUPERIORITY|||||||0.633|||||||ANOVA|||||||.633
91755990|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||70.87|TWO_SIDED|95.0|0.59|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.59|70.87
91755991|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||63.71|TWO_SIDED|95.0|0.51|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.51|63.71
91533473|NCT05302791|182944309|SUPERIORITY|||||||0.076|||||||ANOVA|||||||.076
91533474|NCT05302791|182944310|SUPERIORITY|||||||0.151|||||||ANOVA|||||||.151
91533475|NCT05302791|182944311|SUPERIORITY|||||||0.385|||||||ANOVA|||||||.385
91533476|NCT05302791|182944312|SUPERIORITY|||||||0.665|||||||ANOVA|||||||.665
91533477|NCT05302791|182944313|SUPERIORITY|||||||0.078|||||||ANOVA|||||||.078
91533478|NCT05302791|182944314|SUPERIORITY|||||||0.773|||||||ANOVA|||||||.773
91533479|NCT05302791|182944315|SUPERIORITY|||||||0.118|||||||ANOVA|||||||.118
91533480|NCT05302791|182944316|SUPERIORITY||||||<|0.001|||||||ANOVA|Time x condition ANOVA||||||<0.001
91533481|NCT05302791|182944317|SUPERIORITY||||||<|0.001|||||||ANOVA|time x condition anova||||||<0.001
91533482|NCT03552978|182944318|SUPERIORITY||Odds Ratio (OR)|11.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df - 63||||||<.001
91533483|NCT03552978|182944319|SUPERIORITY||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df = 59||||||<.001
91533484|NCT03552978|182944323|SUPERIORITY||Mean Difference (Final Values)|90.28||||0.39|TWO_SIDED||||||Mixed Models Analysis|df = 3, 152.11||We examined total Cigarettes smoked in the past 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in cigarette use over time by treatment group.||||.39
91759862|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.13|||||TWO_SIDED|95.0|-16.11|-2.14||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.14|-16.11|
91533485|NCT03552978|182944324|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.91|TWO_SIDED||||||Mixed Models Analysis|df = 3, 140.87||We examined days of e-cigarette use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in e-cigarette use over time by treatment group.||||.91
91533486|NCT03552978|182944325|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.66|TWO_SIDED||||||Mixed Models Analysis|df = 3,199||We examined days of chewing tobacco use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in chewing tobacco use over time by treatment group.||||.66
91533487|NCT03552978|182944326|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.76|TWO_SIDED||||||Mixed Models Analysis|df = 3, 102.04||We examined nicotine dependence using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in nicotine dependence over time by treatment group.||||.76
91533488|NCT03552978|182944327|SUPERIORITY||Odds Ratio (OR)|1.99||||0.28|TWO_SIDED|||||Week 12|Chi-squared|df = 1||||||.28
91533489|NCT03552978|182944327|SUPERIORITY||Odds Ratio (OR)|2.3||||0.19|TWO_SIDED|||||Week 24|Chi-squared|df = 1||||||.19
91533490|NCT03552978|182944328|SUPERIORITY||Odds Ratio (OR)|1.68||||0.42|TWO_SIDED||||||Chi-squared|df = 1||Week 12||||.42
91533491|NCT03552978|182944328|SUPERIORITY||Odds Ratio (OR)|2.52||||0.17|TWO_SIDED||||||Chi-squared|df = 1||Week 24||||.17
91755992|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||65.99|TWO_SIDED|95.0|0.57|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.57|65.99
91533492|NCT03552978|182944329|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.58|TWO_SIDED||||||Mixed Models Analysis|df = 3, 100.51||We examined days of changes in PTSD symptoms using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in PTSD symptoms over time by treatment group.||||.58
91533493|NCT04956692|182944333|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.04|||<|0.0001|TWO_SIDED|96.0|0.98|1.1||The one-sided p-value non-inferiority boundary is 0.02|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||1.10|0.98|<0.0001
91533494|NCT04956692|182944334|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.85|||<|0.0001|TWO_SIDED|94.0|1.69|2.03||The one-sided p-value non-inferiority boundary is 0.03|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||2.03|1.69|<0.0001
91533495|NCT03437668|182944355|SUPERIORITY|To test for a differential treatment effect, we fit a linear mixed with group, time, and a group by time interaction as the predictors and random intercepts to account for the correlations induced by the repeated measurements within subjects. Given the form of the trajectories and the small sample size, we chose to treat time as continuous to minimize the number of degrees of freedom and the risk of overfitting.|Slope|-0.22||||0.31|TWO_SIDED|||||p-value is for the interaction of time and treatment group in the mixed model|Mixed Models Analysis|||||||.31
91533496|NCT01449721|182944377|SUPERIORITY_OR_OTHER|||||||0.064|||||||2-sample z-test|z-test for differences in proportions||Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.||||0.064
91755993|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||71.95|TWO_SIDED|95.0|0.6|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.60|71.95
91755994|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.28|TWO_SIDED|95.0|0.71|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.71|48.28
91533497|NCT04447820|182944398|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3084|||||||Mixed Model for repeated measures (MMRM)|||||||0.3084
91533498|NCT04447820|182944398|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.593|||||||Mixed Model for repeated measures (MMRM)|||||||0.5930
91759863|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.88|||||TWO_SIDED|95.0|-16.89|-2.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.88|-16.89|
91755995|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||61.06|TWO_SIDED|95.0|0.65|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.65|61.06
91533499|NCT04447820|182944399|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9788|||||||MMRM|||||||0.9788
91533500|NCT04447820|182944399|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1314|||||||MMRM|||||||0.1314
91533501|NCT04447820|182944400|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.884|||||||MMRM analysis|||||||0.8840
91533502|NCT04447820|182944400|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1202|||||||MMRM analysis|||||||0.1202
91533503|NCT04447820|182944401|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9353|||||||MMRM|||||||0.9353
91533504|NCT04447820|182944401|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3099|||||||MMRM|||||||0.3099
91533505|NCT04447820|182944402|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2098|||||||MMRM|||||||0.2098
91533506|NCT04447820|182944402|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3688|||||||MMRM|||||||0.3688
91533507|NCT04447820|182944403|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.5647|||||||MMRM|||||||0.5647
91755996|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||18.05|TWO_SIDED|95.0|0.82|1.74||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.74|0.82|18.05
91755997|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||61.12|TWO_SIDED|95.0|0.53|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.53|61.12
91755998|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||64.4|TWO_SIDED|95.0|0.61|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.61|64.40
91755999|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||38.12|TWO_SIDED|95.0|0.69|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|0.69|38.12
91756000|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||91|TWO_SIDED|95.0|0.67|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.67|91.00
91756001|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||94.52|TWO_SIDED|95.0|0.62|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.62|94.52
91756002|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||82.11|TWO_SIDED|95.0|0.72|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.72|82.11
91756003|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.1|TWO_SIDED|95.0|0.64|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.64|48.10
91756004|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||65.66|TWO_SIDED|95.0|0.64|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.64|65.66
91756005|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||11.46|TWO_SIDED|95.0|0.87|1.8||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.80|0.87|11.46
91756006|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||77.2|TWO_SIDED|95.0|0.7|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.70|77.20
91513516|NCT03029208|182898961|SUPERIORITY||Ratio of exacerbation rate|1.01||||0.5174|TWO_SIDED|95.0|0.73|1.39|||Negative binomial model||Model estimated exacerbation rates, ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.39|0.73|0.5174
91513517|NCT03029208|182898963|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.04|||||TWO_SIDED|95.0|-0.29|0.36|||||The difference in change from Baseline in post-randomization Hgb at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||0.36|-0.29|
91513518|NCT03029208|182898964|SUPERIORITY||Difference in response rate|-0.8||||0.5411|TWO_SIDED|95.0|-12.2|10.7|||Cochran-Mantel-Haenszel||A Cochran-Mantel-Haenszel (CMH) test adjusted for treatment and randomization stratification factors were used to compare the number of responders between the treatment groups.|||10.7|-12.2|0.5411
91513519|NCT03029208|182898965|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.05|||||TWO_SIDED|95.0|-4.45|11.27|||||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||11.27|-4.45|
91513520|NCT03029208|182898966|SUPERIORITY||Probability|0.54||||0.1538|TWO_SIDED|95.0|0.46|0.61|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.61|0.46|0.1538
91513521|NCT03029208|182898967|OTHER||Hazard Ratio (HR)|1.06||||0.5348|TWO_SIDED|95.0|0.31|3.66|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and dialysis start manner.|||3.66|0.31|0.5348
91513522|NCT03029208|182898968|SUPERIORITY||LS mean difference|-0.39||||0.6641|TWO_SIDED|95.0|-2.22|1.44|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.44|-2.22|0.6641
91756007|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||87.35|TWO_SIDED|95.0|0.66|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.66|87.35
91513523|NCT03029208|182898968|SUPERIORITY||LS mean difference|1.13||||0.103|TWO_SIDED|95.0|-0.63|2.89|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.89|-0.63|0.1030
91513524|NCT03029208|182898968|SUPERIORITY||LS mean difference|0.49||||0.3157|TWO_SIDED|95.0|-1.51|2.48|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.48|-1.51|0.3157
91513525|NCT03029208|182898968|SUPERIORITY||LS mean difference|-1.31||||0.8855|TWO_SIDED|95.0|-3.46|0.84|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.84|-3.46|0.8855
91513526|NCT03029208|182898969|SUPERIORITY||LS mean difference|-0.67||||0.7146|TWO_SIDED|95.0|-2.99|1.66|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.66|-2.99|0.7146
91513527|NCT03029208|182898969|SUPERIORITY||LS mean difference|-1.53||||0.905|TWO_SIDED|95.0|-3.82|0.76|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.76|-3.82|0.9050
91513528|NCT03029208|182898969|SUPERIORITY||LS mean difference|-0.32||||0.595|TWO_SIDED|95.0|-2.91|2.28|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.28|-2.91|0.5950
91513529|NCT03029208|182898969|SUPERIORITY||LS mean difference|-0.23||||0.5619|TWO_SIDED|95.0|-3.17|2.7|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.70|-3.17|0.5619
91513530|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.14||||0.4523|TWO_SIDED|95.0|-2.21|2.49|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.49|-2.21|0.4523
91513531|NCT03029208|182898970|SUPERIORITY||LS mean difference|-0.07||||0.5222|TWO_SIDED|95.0|-2.57|2.43|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.43|-2.57|0.5222
91513532|NCT03029208|182898970|SUPERIORITY||LS mean difference|2.33||||0.044|TWO_SIDED|95.0|-0.35|5.02|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||5.02|-0.35|0.0440
91513533|NCT03029208|182898970|SUPERIORITY||LS mean difference|-2.61||||0.9523|TWO_SIDED|95.0|-5.68|0.46|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.46|-5.68|0.9523
91513534|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.05||||0.4811|TWO_SIDED|95.0|-1.82|1.91|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.91|-1.82|0.4811
91513535|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.28||||0.3834|TWO_SIDED|95.0|-1.56|2.11|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.11|-1.56|0.3834
91513536|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.26||||0.3983|TWO_SIDED|95.0|-1.72|2.24|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.24|-1.72|0.3983
91513537|NCT03029208|182898970|SUPERIORITY||LS mean difference|-0.18||||0.5617|TWO_SIDED|95.0|-2.51|2.15|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.15|-2.51|0.5617
91513538|NCT03029208|182898970|SUPERIORITY||LS mean difference|-1.15||||0.8336|TWO_SIDED|95.0|-3.48|1.18|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.18|-3.48|0.8336
91513539|NCT03029208|182898970|SUPERIORITY||LS mean difference|-1.41||||0.9188|TWO_SIDED|95.0|-3.4|0.57|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.57|-3.40|0.9188
91513540|NCT03029208|182898970|SUPERIORITY||LS mean difference|-0.48||||0.6495|TWO_SIDED|95.0|-2.96|1.99|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.99|-2.96|0.6495
91513541|NCT03029208|182898970|SUPERIORITY||LS mean difference|-0.27||||0.5737|TWO_SIDED|95.0|-3.09|2.56|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.56|-3.09|0.5737
91513542|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.33||||0.3963|TWO_SIDED|95.0|-2.15|2.82|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.82|-2.15|0.3963
91513543|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.62||||0.322|TWO_SIDED|95.0|-2.01|3.25|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||3.25|-2.01|0.3220
91756008|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||56.53|TWO_SIDED|95.0|0.77|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.77|56.53
91756009|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||7.29|TWO_SIDED|95.0|0.94|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.94|7.29
91756010|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.09|TWO_SIDED|95.0|0.75|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.75|55.09
91756011|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.79||||96.49|TWO_SIDED|95.0|0.61|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.61|96.49
91756012|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||14.54|TWO_SIDED|95.0|0.9|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.90|14.54
91756013|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||66.85|TWO_SIDED|95.0|0.71|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.71|66.85
91756014|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||85.77|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.77
91756015|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.24||||8.67|TWO_SIDED|95.0|0.91|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.91|8.67
91756016|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||14.8|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|14.80
91756017|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||45.69|TWO_SIDED|95.0|0.75|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.75|45.69
91756018|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||2.94|TWO_SIDED|95.0|0.99|2.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.06|0.99|2.94
91756019|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||13.92|TWO_SIDED|95.0|0.85|1.73||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.73|0.85|13.92
91533508|NCT04447820|182944403|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.217|||||||MMRM|||||||0.2170
91756020|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||86.4|TWO_SIDED|95.0|0.65|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.65|86.40
91756021|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.46||||0.88|TWO_SIDED|95.0|1.06|2.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.00|1.06|0.88
91510463|NCT02033889|182892778|SUPERIORITY||Adjusted Odds Ratio|5.41|||<|0.001|TWO_SIDED|95.0|2.1|13.9|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|13.90|2.10|<0.001
91510464|NCT02033889|182892778|SUPERIORITY||Adjusted Odds Ratio|3.1||||0.023|TWO_SIDED|95.0|1.17|8.22|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|8.22|1.17|0.023
91510465|NCT02033889|182892779|SUPERIORITY||Difference in % vs Placebo|-16.2|||<|0.001|TWO_SIDED|95.0|-22.2|-11.2|||Miettinen & Nurminen method|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-11.2|-22.2|<0.001
91510466|NCT02033889|182892779|SUPERIORITY||Difference in % vs Placebo|-14.8|||<|0.001|TWO_SIDED|95.0|-20.9|-9.4|||Miettinen & Nurminen method.|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-9.4|-20.9|<0.001
91510467|NCT02033889|182892798|OTHER||Difference in the Least Squares Means|-0.1|||||TWO_SIDED|95.0|-0.71|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-0.71|
91510468|NCT02033889|182892798|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|97.0|-0.83|0.37|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.37|-0.83|
91510469|NCT02033889|182892799|OTHER||Difference in the Least Squares Means|0.7|||||TWO_SIDED|95.0|0.0|1.39|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.39|0.00|
91510470|NCT02033889|182892799|OTHER||Difference in the Least Squares Means|0.3|||||TWO_SIDED|95.0|-0.38|0.99|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.99|-0.38|
91510471|NCT02033889|182892800|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.15|0.68|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.68|-0.15|
91510472|NCT02033889|182892800|OTHER||Difference in the Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.33|0.48|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.48|-0.33|
91510473|NCT02033889|182892801|OTHER||Difference in the Least Squares Means|-0.19|||||TWO_SIDED|95.0|-0.76|0.39|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.39|-0.76|
91510474|NCT02033889|182892801|OTHER||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.78|0.35|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.35|-0.78|
91510475|NCT02033889|182892805|OTHER||Difference in the Least Squares Means|0.17|||||TWO_SIDED|95.0|-0.53|0.88|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.88|-0.53|
91533509|NCT04447820|182944404|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2562|||||||MMRM|||||||0.2562
91533510|NCT04447820|182944404|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.4268|||||||MMRM|||||||0.4268
91533511|NCT03298815|182944446|SUPERIORITY|||||||0.375|||||||McNemar|||||||0.375
91533512|NCT03298815|182944447|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
91533513|NCT03298815|182944448|SUPERIORITY|||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
91533514|NCT03298815|182944449|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
91533515|NCT03298815|182944450|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
91533516|NCT03298815|182944451|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.00
91533517|NCT03298815|182944452|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
91533518|NCT03298815|182944453|SUPERIORITY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
91756022|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||41.25|TWO_SIDED|95.0|0.75|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.75|41.25
91533519|NCT03298815|182944454|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91533520|NCT03298815|182944455|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
91533521|NCT03298815|182944456|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
91533522|NCT03298815|182944457|SUPERIORITY|||||||0.594||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.594
91533523|NCT03298815|182944457|SUPERIORITY|||||||0.469||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||0.469
91533524|NCT03298815|182944457|SUPERIORITY|||||||0.75||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.750
91533525|NCT03298815|182944458|SUPERIORITY|||||||0.063||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.063
91756023|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||99.2|TWO_SIDED|95.0|0.52|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.52|99.20
91533526|NCT03298815|182944458|SUPERIORITY||||||<|1||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||<1.000
91533527|NCT03298815|182944458|SUPERIORITY|||||||0.25||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.250
91533528|NCT04996069|182944459|SUPERIORITY|No power calculation performed.||||||0.45||||||p value threshold is .05|t-test, 2 sided|||||||.45
91533529|NCT00935792|182944463|OTHER||||||||||||||||||Estimated maximum tolerated dose was 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.|||
91533530|NCT04019561|182944490|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.439|TWO_SIDED|95.0|-5.02|2.2|||ANCOVA|||||2.20|-5.02|0.439
91533531|NCT04019561|182944490|SUPERIORITY||Mean Difference (Final Values)|-5.01||||0.006|TWO_SIDED|95.0|-8.54|-1.48|||ANCOVA|||||-1.48|-8.54|0.006
91533532|NCT04019561|182944491|SUPERIORITY||Mean Difference (Final Values)|-1.508||||0.695|TWO_SIDED|95.0|-9.191|6.174|||ANCOVA|||||6.174|-9.191|0.695
91533533|NCT04019561|182944491|SUPERIORITY||Mean Difference (Final Values)|-9.291||||0.016|TWO_SIDED|95.0|-16.76|-1.822|||ANCOVA|||||-1.822|-16.760|0.016
91533534|NCT04019561|182944492|SUPERIORITY||Mean Difference (Final Values)|-10.74||||0.468|TWO_SIDED|95.0|-40.174|18.695|||ANCOVA|||||18.695|-40.174|0.468
91533535|NCT04019561|182944492|SUPERIORITY||Mean Difference (Final Values)|-37.395||||0.012|TWO_SIDED|95.0|-66.38|-8.409|||ANCOVA|||||-8.409|-66.380|0.012
91533536|NCT04019561|182944493|SUPERIORITY||Mean Difference (Final Values)|6.26||||0.166|TWO_SIDED|95.0|-2.698|15.218|||ANCOVA|||||15.218|-2.698|0.166
91533537|NCT04019561|182944493|SUPERIORITY||Mean Difference (Final Values)|0.749||||0.856|TWO_SIDED|95.0|-7.537|9.035|||ANCOVA|||||9.035|-7.537|0.856
91533538|NCT04019561|182944494|SUPERIORITY||Mean Difference (Final Values)|-3.283||||0.302|TWO_SIDED|95.0|-9.641|3.076|||ANCOVA|||||3.076|-9.641|0.302
91533539|NCT04019561|182944494|SUPERIORITY||Mean Difference (Final Values)|-2.821||||0.304|TWO_SIDED|95.0|-8.316|2.675|||ANCOVA|||||2.675|-8.316|0.304
91533540|NCT04019561|182944495|SUPERIORITY||Mean Difference (Final Values)|1.038||||0.808|TWO_SIDED|95.0|-7.493|9.569|||ANCOVA|||||9.569|-7.493|0.808
91533541|NCT04019561|182944495|SUPERIORITY||Mean Difference (Final Values)|1.106||||0.786|TWO_SIDED|95.0|-7.043|9.255|||ANCOVA|||||9.255|-7.043|0.786
91533542|NCT04019561|182944496|SUPERIORITY||Mean Difference (Final Values)|3.448||||0.087|TWO_SIDED|95.0|-0.524|7.421|||ANCOVA|||||7.421|-0.524|0.087
91533543|NCT04019561|182944496|SUPERIORITY||Mean Difference (Final Values)|-0.387||||0.834|TWO_SIDED|95.0|-4.085|3.312|||ANCOVA|||||3.312|-4.085|0.834
91533544|NCT04019561|182944497|SUPERIORITY||Mean Difference (Final Values)|-0.386||||0.735|TWO_SIDED|95.0|-2.681|1.908|||ANCOVA|||||1.908|-2.681|0.735
91533545|NCT04019561|182944497|SUPERIORITY||Mean Difference (Final Values)|-1.091||||0.308|TWO_SIDED|95.0|-3.226|1.044|||ANCOVA|||||1.044|-3.226|0.308
91533546|NCT04019561|182944498|SUPERIORITY||Mean Difference (Final Values)|-19.277||||0.195|TWO_SIDED|95.0|-48.704|10.15|||ANCOVA|||||10.150|-48.704|0.195
91533547|NCT04019561|182944498|SUPERIORITY||Mean Difference (Final Values)|-24.328||||0.103|TWO_SIDED|95.0|-53.674|5.019|||ANCOVA|||||5.019|-53.674|0.103
91533548|NCT04019561|182944499|SUPERIORITY||Mean Difference (Final Values)|-10.39||||0.6|TWO_SIDED|95.0|-49.802|29.022|||ANCOVA|||||29.022|-49.802|0.600
91533549|NCT04019561|182944499|SUPERIORITY||Mean Difference (Final Values)|7.086||||0.72|TWO_SIDED|95.0|-32.163|46.336|||ANCOVA|||||46.336|-32.163|0.720
91533550|NCT04019561|182944500|SUPERIORITY||Mean Difference (Final Values)|-9.14||||0.485|TWO_SIDED|95.0|-35.134|16.854|||ANCOVA|||||16.854|-35.134|0.485
91533551|NCT04019561|182944500|SUPERIORITY||Mean Difference (Final Values)|-19.645||||0.131|TWO_SIDED|95.0|-45.288|5.999|||ANCOVA|||||5.999|-45.288|0.131
91533552|NCT04019561|182944501|SUPERIORITY||Mean Difference (Final Values)|-0.719||||0.564|TWO_SIDED|95.0|-3.191|1.754|||ANCOVA|||||1.754|-3.191|0.564
91533553|NCT04019561|182944501|SUPERIORITY||Mean Difference (Final Values)|-2.366||||0.062|TWO_SIDED|95.0|-4.854|0.122|||ANCOVA|||||0.122|-4.854|0.062
91533554|NCT04019561|182944502|SUPERIORITY||Mean Difference (Final Values)|-0.084||||0.856|TWO_SIDED|95.0|-1.007|0.838|||ANCOVA|||||0.838|-1.007|0.856
91533555|NCT04019561|182944502|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.098|TWO_SIDED|95.0|-1.7|0.147|||ANCOVA|||||0.147|-1.700|0.098
91533556|NCT03005288|182944547|SUPERIORITY||Mean Difference (Net)|-7.31|||<|0.001|TWO_SIDED|80.0|-8.48|-6.14|||Mixed-Effect Model Repeated Measure|||||-6.14|-8.48|<0.001
91533557|NCT03005288|182944548|SUPERIORITY||Mean Difference (Net)|-5.19|||<|0.001|TWO_SIDED|80.0|-6.01|-4.37|||Mixed-Effect Model Repeated Measure|||||-4.37|-6.01|<0.001
91533558|NCT03005288|182944549|SUPERIORITY||Mean Difference (Net)|-1.13|||<|0.001|TWO_SIDED|80.0|-1.42|-0.83|||Mixed Models Analysis|||week 24||-0.83|-1.42|<0.001
91533559|NCT03005288|182944549|SUPERIORITY||Mean Difference (Net)|-0.8||||0.005|TWO_SIDED|80.0|-1.2|-0.41|||Mixed Models Analysis|||week 48||-0.41|-1.20|0.005
91533560|NCT03005288|182944553|SUPERIORITY||Mean Difference (Net)|-1.33|||<|0.001|TWO_SIDED|80.0|-1.71|-0.95|||Mixed-Effect Model Repeated Measure|||week 24||-0.95|-1.71|<0.001
91533561|NCT03005288|182944553|SUPERIORITY||Mean Difference (Net)|-1.91|||<|0.001|TWO_SIDED|80.0|-2.48|-1.34|||Mixed-Effect Model Repeated Measure|||week 48||-1.34|-2.48|<0.001
91533562|NCT03005288|182944554|SUPERIORITY||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|80.0|-4.54|-2.31|||Mixed-Effect Model Repeated Measure|||week 24||-2.31|-4.54|<0.001
91533563|NCT03005288|182944554|SUPERIORITY||Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|80.0|-6.74|-3.47|||Mixed-Effect Model Repeated Measure|||week 48||-3.47|-6.74|<0.001
91533564|NCT03005288|182944555|SUPERIORITY||Mean Difference (Net)|1.49||||0.003|TWO_SIDED|80.0|0.82|2.06|||Mixed-Effect Model Repeated Measure|||week 24||2.06|0.82|0.003
91533565|NCT03005288|182944555|SUPERIORITY||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|80.0|1.36|2.93|||Mixed-Effect Model Repeated Measure|||week 48||2.93|1.36|<0.001
91533566|NCT03005288|182944556|SUPERIORITY||Mean Difference (Net)|-4.09|||<|0.001|TWO_SIDED|80.0|-5.26|-2.92|||Mixed-Effect Model Repeated Measure|||week 24||-2.92|-5.26|<0.001
91533567|NCT03005288|182944556|SUPERIORITY||Mean Difference (Net)|-9.46|||<|0.001|TWO_SIDED|80.0|-11.3|-7.64|||Mixed-Effect Model Repeated Measure|||week 52||-7.64|-11.3|<0.001
91533568|NCT03005288|182944557|SUPERIORITY||Mean Difference (Net)|-0.02||||0.062|TWO_SIDED|80.0|-0.03|0.0|||Mixed-Effect Model Repeated Measure|||week 24||-0.00|-0.03|0.062
91533569|NCT03005288|182944557|SUPERIORITY||Mean Difference (Net)|-0.06|||<|0.001|TWO_SIDED|80.0|-0.08|-0.04|||Mixed-Effect Model Repeated Measure|||week 52||-0.04|-0.08|<0.001
91756024|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.49|TWO_SIDED|95.0|0.98|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.98|3.49
91756025|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||73.09|TWO_SIDED|95.0|0.72|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.72|73.09
91756026|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||92.41|TWO_SIDED|95.0|0.69|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.69|92.41
91756027|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||2.29|TWO_SIDED|95.0|1.01|1.89||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.89|1.01|2.29
91510476|NCT02033889|182892805|OTHER||Difference in the Least Squares Means|-0.18|||||TWO_SIDED|97.0|-0.88|0.51|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.51|-0.88|
91510477|NCT02033889|182892806|OTHER||Difference in the Least Squares Means|0.25|||||TWO_SIDED|95.0|-0.48|0.98|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.98|-0.48|
91510478|NCT02033889|182892806|OTHER||Difference in the Least Squares Means|0.2|||||TWO_SIDED|95.0|-0.51|0.91|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.91|-0.51|
91510479|NCT02033889|182892807|OTHER||Difference in the Least Squares Means|-0.5|||||TWO_SIDED|95.0|-0.95|-0.04|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.04|-0.95|
91510480|NCT02033889|182892807|OTHER||Difference in the Least Squares Means|-0.22|||||TWO_SIDED|95.0|-0.66|0.23|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.23|-0.66|
91510481|NCT02033889|182892808|OTHER||Difference in the Least Squares Means|0.06|||||TWO_SIDED|95.0|-0.61|0.72|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.72|-0.61|
91510482|NCT02033889|182892808|OTHER||Difference in the Least Squares Means|-0.15|||||TWO_SIDED|95.0|-0.78|0.49|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.78|
91510483|NCT02033889|182892812|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|95.0|-1.01|0.56|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.56|-1.01|
91510484|NCT02033889|182892812|OTHER||Difference in the Least Squares Means|-0.28|||||TWO_SIDED|97.0|-1.06|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-1.06|
91510485|NCT02033889|182892813|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.58|1.13|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.13|-0.58|
91756028|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||23.67|TWO_SIDED|95.0|0.81|1.56||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.56|0.81|23.67
91533570|NCT03005288|182944558|SUPERIORITY||Mean Difference (Net)|-0.65||||0.028|TWO_SIDED|80.0|-1.03|-0.28|||Mixed-Effect Model Repeated Measure|||week 12||-0.28|-1.03|0.028
91533571|NCT03005288|182944558|SUPERIORITY||Mean Difference (Net)|-0.66||||0.081|TWO_SIDED|80.0|-1.14|-0.18|||Mixed-Effect Model Repeated Measure|||week 36||-0.18|-1.14|0.081
91756029|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||98.87|TWO_SIDED|95.0|0.59|0.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.96|0.59|98.87
91756030|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||14.5|TWO_SIDED|95.0|0.95|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.95|14.50
91756031|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||30.26|TWO_SIDED|95.0|0.91|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.91|30.26
91756032|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||62.84|TWO_SIDED|95.0|0.89|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.89|62.84
91756033|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||2.06|TWO_SIDED|95.0|1.01|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|1.01|2.06
91756034|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.97|TWO_SIDED|95.0|0.76|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.76|49.97
91756035|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.76||||99.43|TWO_SIDED|95.0|0.62|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.62|99.43
91756036|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.2||||1.17|TWO_SIDED|95.0|1.02|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|1.02|1.17
91756037|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.78|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.84|49.78
91533572|NCT04011033|182944560|OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.16|0.63|||Log Rank|||||0.63|0.16|<0.001
91533573|NCT04011033|182944562|OTHER||||||=|0.003|||||||Fisher Exact|||||||=0.003
91533574|NCT04011033|182944563|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91533575|NCT04011033|182944565|OTHER||Hazard Ratio (HR)|0.37|||=|0.001|TWO_SIDED|95.0|0.19|0.71|||Log Rank|||||0.71|0.19|=0.001
91533576|NCT01823341|182944566|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91533577|NCT01823341|182944567|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
91533578|NCT01823341|182944567|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
91533579|NCT01823341|182944568|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91756038|NCT02294734|183404489|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||98.66|TWO_SIDED|95.0|0.73|0.98||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.98|0.73|98.66
91756039|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|32.51
91533580|NCT01823341|182944568|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
91533581|NCT01823341|182944569|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91756040|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.21|TWO_SIDED|95.0|0.99|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.99|6.21
91756041|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||15.91|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|15.91
91756042|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.73|TWO_SIDED|95.0|0.99|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.99|6.73
91756043|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||27.65|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|27.65
91756044|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||12.19|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|12.19
91756045|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||11.62|TWO_SIDED|95.0|0.98|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.98|11.62
91756046|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||7.66|TWO_SIDED|95.0|0.99|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.99|7.66
91533582|NCT01823341|182944569|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
91533583|NCT01823341|182944570|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
91533584|NCT01823341|182944570|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
91533585|NCT01823341|182944571|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
91533586|NCT01823341|182944571|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||0.77
91533587|NCT01823341|182944572|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91533588|NCT01823341|182944572|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
91533589|NCT01823341|182944573|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
91533590|NCT01823341|182944573|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
91533591|NCT01823341|182944574|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
91533592|NCT01823341|182944574|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
91533593|NCT01823341|182944575|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
91533594|NCT01823341|182944575|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
91756047|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.88|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.88
91756048|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.28|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.28
91756049|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||27.87|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|27.87
91756050|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||9.83|TWO_SIDED|95.0|0.99|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.99|9.83
91756051|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||21.87|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|21.87
91756052|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||18.58|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|18.58
91756053|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.28|TWO_SIDED|95.0|0.98|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.98|22.28
91756054|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||10.86|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|10.86
91756055|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.89|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.89
91756056|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.78|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.78
91756057|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||69.42|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|69.42
91756058|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||62.63|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|62.63
91759864|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61|||||TWO_SIDED|95.0|-9.63|4.4||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.40|-9.63|
91533595|NCT01125774|182944593|SUPERIORITY_OR_OTHER||Difference in percent incidence|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||2.1|-4.4|
91756059|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||72.55|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|72.55
91533596|NCT01125774|182944594|SUPERIORITY_OR_OTHER||Difference in percent incidence|-0.2|||||TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||0.8|-1.4|
91756060|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||36.28|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|36.28
91533597|NCT01125774|182944595|SUPERIORITY_OR_OTHER||Difference in percent incidence|0.6|||||TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||1.6|-0.5|
91533598|NCT01125774|182944597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.13|TWO_SIDED|95.0|-1.1|0.1||α=0.0499|Longitudinal data analysis (LDA)||Difference is Telcagepant 140 mg versus Placebo|This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM||0.1|-1.1|0.130
91533599|NCT01125774|182944598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.369|TWO_SIDED|95.0|-1.0|0.4||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.4|-1.0|0.369
91756061|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.44|TWO_SIDED|95.0|0.96|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.96|47.44
91756062|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.99|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|22.99
91756063|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||85.95|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|85.95
91510486|NCT02033889|182892813|OTHER||Difference in the Least Squares Means|0.12|||||TWO_SIDED|95.0|-0.7|0.93|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.93|-0.70|
91510487|NCT02033889|182892814|OTHER||Difference in the Least Squares Means|-0.84|||||TWO_SIDED|95.0|-1.44|-0.24|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.24|-1.44|
91510488|NCT02033889|182892814|OTHER||Difference in the least Squares Means|-0.54|||||TWO_SIDED|95.0|-1.12|0.05|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.05|-1.12|
91510489|NCT02033889|182892815|OTHER||Difference in the Least Squares Means|-0.06|||||TWO_SIDED|95.0|-0.77|0.65|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.65|-0.77|
91510490|NCT02033889|182892815|OTHER||Difference in the Least Squares Means|0.18|||||TWO_SIDED|95.0|-0.5|0.85|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.85|-0.50|
91510491|NCT02391948|182892846|OTHER||mean population value age 12|98.3|||||TWO_SIDED|95.0|97.8|98.6||||||||98.6|97.8|
91510492|NCT02391948|182892846|OTHER||mean population value age 12|89.1|||||TWO_SIDED|95.0|86.6|91.1||||||||91.1|86.6|
91510493|NCT02391948|182892846|OTHER||mean population value age 12|50.1|||||TWO_SIDED|95.0|46.5|53.6||||||||53.6|46.5|
91510494|NCT02391948|182892846|OTHER||mean population value age 12|25.3|||||TWO_SIDED|95.0|23.7|27.0||||||||27.0|23.7|
91510495|NCT02391948|182892846|OTHER||mean population value age 12|6.48|||||TWO_SIDED|95.0|5.66|7.38||||||||7.38|5.66|
91510496|NCT02391948|182892847|OTHER||mean population value age 12|0.44|||||TWO_SIDED|95.0|0.38|0.49||||||||0.49|0.38|
91510497|NCT02391948|182892847|OTHER||mean population value age 12|0.68|||||TWO_SIDED|95.0|0.6|0.77||||||||0.77|0.60|
91510498|NCT02391948|182892847|OTHER||mean population value age 12|0.93|||||TWO_SIDED|95.0|0.79|1.07||||||||1.07|0.79|
91510499|NCT02391948|182892847|OTHER||mean population value age 12|1.38|||||TWO_SIDED|95.0|1.22|1.54||||||||1.54|1.22|
91510500|NCT02391948|182892847|OTHER||mean population value age 12|2.16|||||TWO_SIDED|95.0|2.01|2.31||||||||2.31|2.01|
91510501|NCT02391948|182892848|OTHER||mean population value|4.49|||||TWO_SIDED|95.0|4.43|4.54||||||||4.54|4.43|
91510502|NCT02391948|182892848|OTHER||mean population value|4.1|||||TWO_SIDED|95.0|3.99|4.2||||||||4.20|3.99|
91510503|NCT02391948|182892848|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.75|4.25||||||||4.25|3.75|
91510504|NCT02391948|182892848|OTHER||mean population value|2.95|||||TWO_SIDED|95.0|2.73|3.19||||||||3.19|2.73|
91510505|NCT02391948|182892848|OTHER||mean population value|1.59|||||TWO_SIDED|95.0|1.44|1.75||||||||1.75|1.44|
91510506|NCT02391948|182892849|OTHER||mean population value|1362.3|||||TWO_SIDED|95.0|1313.6|1410.7||||||||1410.7|1313.6|
91510507|NCT02391948|182892849|OTHER||mean population value|1096.33|||||TWO_SIDED|95.0|1028.8|1158.62||||||||1158.62|1028.80|
91510508|NCT02391948|182892849|OTHER||mean population value|592.62|||||TWO_SIDED|95.0|533.79|652.72||||||||652.72|533.79|
91510509|NCT02391948|182892850|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.91|4.07||||||||4.07|3.91|
91510510|NCT02391948|182892850|OTHER||mean population value|3.49|||||TWO_SIDED|95.0|3.39|3.6||||||||3.60|3.39|
91510511|NCT02391948|182892850|OTHER||mean population value|3.23|||||TWO_SIDED|95.0|3.08|3.37||||||||3.37|3.08|
91510512|NCT02391948|182892850|OTHER||mean population value|2.8|||||TWO_SIDED|95.0|2.67|2.93||||||||2.93|2.67|
91510513|NCT02391948|182892850|OTHER||mean population value|1.79|||||TWO_SIDED|95.0|1.67|1.91||||||||1.91|1.67|
91510514|NCT02391948|182892851|OTHER||mean population value|0.59|||||TWO_SIDED|9.0|0.47|0.72||||||||0.72|0.47|
91510515|NCT02391948|182892851|OTHER||mean population value|1.1|||||TWO_SIDED|95.0|0.91|1.3||||||||1.30|0.91|
91510516|NCT02391948|182892851|OTHER||mean population value|0.68|||||TWO_SIDED|95.0|0.48|0.89||||||||0.89|0.48|
91510517|NCT02391948|182892851|OTHER||mean population value|1.38|||||TWO_SIDED|95.0|1.12|1.65||||||||1.65|1.12|
91510518|NCT02391948|182892851|OTHER||mean population value|2.33|||||TWO_SIDED|95.0|2.08|2.6||||||||2.60|2.08|
91510519|NCT02391948|182892852|OTHER||mean population value age 12|70.6|||||TWO_SIDED|95.0|69.1|72.0||||||||72.0|69.1|
91510520|NCT02391948|182892852|OTHER||mean population value age 12|62.1|||||TWO_SIDED|95.0|59.4|65.0||||||||65.0|59.4|
91510521|NCT02391948|182892852|OTHER||mean population value age 12|62.9|||||TWO_SIDED|95.0|60.9|65.0||||||||65.0|60.9|
91510522|NCT02391948|182892852|OTHER||mean population value age 12|58.2|||||TWO_SIDED|95.0|56.7|59.7||||||||59.7|56.7|
91510523|NCT02391948|182892852|OTHER||mean population value age 12|51.9|||||TWO_SIDED|95.0|50.2|53.6||||||||53.6|50.2|
91510524|NCT02391948|182892853|OTHER||mean population value age 12|78.3|||||TWO_SIDED|95.0|76.0|80.4||||||||80.4|76.0|
91510525|NCT02391948|182892853|OTHER||mean population value age 12|66.1|||||TWO_SIDED|95.0|63.5|68.5||||||||68.5|63.5|
91510526|NCT02391948|182892853|OTHER||mean population value age 12|60.5|||||TWO_SIDED|95.0|57.3|63.3|||mean population value age 12|||||63.3|57.3|
91510527|NCT02391948|182892853|OTHER||mean population value age 12|37.9|||||TWO_SIDED|95.0|35.6|40.3||||||||40.3|35.6|
91510528|NCT02391948|182892853|OTHER||mean population value age 12|14.5|||||TWO_SIDED|95.0|12.4|16.5||||||||16.5|12.4|
91756064|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||60.2|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|60.20
91756065|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||81.34|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|81.34
91756066|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.04|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.04
91510529|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.06|2.02|||||Data from all GMFCS levels was used, country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in family-centredness outcome.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor family-centred service.||2.02|1.06|
91510530|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.07|2.03|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor parents' perception of needs being met.||2.03|1.07|
91510531|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.96|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in the amount of focus on environment.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.38|0.96|
91510532|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|1.07|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in focus on participation.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.58|1.07|
91510533|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of physical therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of physical therapy services.||1.58|0.72|
91510534|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.74|1.28|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of occupational therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of occupational therapy.||1.28|0.74|
91510535|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.97|1.6|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of speech and language therapy.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of speech and language therapy.||1.60|0.97|
91510536|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.88|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor family-centred service.||1.88|1.00|
91510537|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.44|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor family-centred service.||1.44|0.78|
91510538|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.54|1.26|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor family-centred service.||1.26|0.54|
91533600|NCT01125774|182944599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
91533601|NCT01125774|182944600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
91533602|NCT01125774|182944601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.393|TWO_SIDED|95.0|-0.4|0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.2|-0.4|0.393
91533603|NCT01449929|182944608|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.1||||0.025|TWO_SIDED|95.0|0.9|13.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Stratified analysis|Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (\<=100,000 c/mL vs \>100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).|||13.2|0.9|0.025
91533604|NCT03253653|182944624|OTHER||z score|1.578||||0.115|TWO_SIDED||||||Wilcoxon signed-rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.115
91533605|NCT03253653|182944625|OTHER||z|0.497||||0.619|TWO_SIDED||||||z||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.619
91533606|NCT03253653|182944626|OTHER||z|1.72||||0.085|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.085
91533607|NCT03253653|182944627|OTHER||z|6.154|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||<0.001
91533608|NCT03253653|182944628|OTHER||z|-1.144||||0.253|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in systolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.253
91533609|NCT03253653|182944629|OTHER||z|-1.004||||0.315|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in diastolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in diastolic blood pressure for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.315
91533610|NCT03253653|182944630|OTHER||z|3.089||||0.002|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in heart rate for the Charcoal-heated tobacco smoking session (n=50) was significantly different from the pre-to-post change in heart rate for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.002
91533611|NCT03253653|182944631|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
91533612|NCT03253653|182944632|OTHER||z|-4.541|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
91533613|NCT03253653|182944633|OTHER||z|-2.569||||0.01|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the 1-HOP metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||.010
91533614|NCT03253653|182944634|OTHER||z|-7.03|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
91533615|NCT03253653|182944635|OTHER||z|-1.304||||0.192|TWO_SIDED||||||Mann-Whitney U test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.192
91533616|NCT03253653|182944636|OTHER||z|-2.136||||0.033|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.033
91533617|NCT03253653|182944637|OTHER||z|-1.22||||0.223|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.223
91533618|NCT03253653|182944638|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
91533619|NCT03253653|182944639|OTHER||z|-1.248||||0.212|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.212
91533620|NCT03253653|182944640|OTHER||z|-2.721||||0.007|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.007
91533621|NCT03253653|182944641|OTHER||z|2.778||||0.006|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.006
91533622|NCT03253653|182944642|OTHER||z|-0.832||||0.406|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of systolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.406
91533623|NCT03253653|182944643|OTHER||z|-1.467||||0.142|TWO_SIDED||||||Mann-Whitney U ranksum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.142
91533624|NCT03253653|182944644|OTHER||z|-0.596||||0.551|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.551
91533625|NCT03253653|182944645|OTHER||z|-0.787||||0.431|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.431
91533626|NCT03253653|182944646|OTHER||z|-0.652||||0.515|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.515
91756067|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||69.67|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|69.67
91533627|NCT03253653|182944647|OTHER||z|-2.394||||0.017|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0. 017
91533628|NCT03253653|182944648|OTHER||z|-1.286||||0.199|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.199
91533629|NCT03253653|182944649|OTHER||z|-3.091||||0.002|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.002
91533630|NCT03253653|182944650|OTHER||z|0.13||||0.896|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.896
91533631|NCT03253653|182944651|OTHER||z|-0.362||||0.717|TWO_SIDED||||||The Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.717
91533632|NCT03253653|182944652|OTHER||z|2.233||||0.026|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.026
91533633|NCT03253653|182944653|OTHER||z|0.383||||0.702|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.702
91533634|NCT03253653|182944654|OTHER||z|2.244||||0.025|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.025
91533635|NCT02857283|182944664|SUPERIORITY|||||||0.46|||||||ANOVA|paired||||||0.46
91533636|NCT02857283|182944665|SUPERIORITY|||||||0.0481|||||||ANOVA|Paired||||||0.0481
91533637|NCT02857283|182944666|SUPERIORITY|||||||0.0179|||||||ANOVA|||||||0.0179
91533638|NCT02857283|182944667|SUPERIORITY|||||||0.1|||||||ANOVA|paired||||||0.10
91533639|NCT02857283|182944668|SUPERIORITY|||||||0.69|||||||ANOVA|paired||||||0.69
91533640|NCT02857283|182944669|SUPERIORITY|||||||0.27|||||||ANOVA|paired||||||0.27
91533641|NCT02857283|182944670|SUPERIORITY|||||||0.5|||||||ANOVA|paired||||||0.50
91533642|NCT02857283|182944671|SUPERIORITY|||||||0.54|||||||Wilcoxon signed rank test|||||||0.54
91756068|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||39.81|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|39.81
91756069|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||73.01|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|73.01
91756070|NCT02294734|183404490|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.97|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|48.97
91756071|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||2.89|TWO_SIDED|95.0|1.0|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|1.00|2.89
91756072|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||8.49|TWO_SIDED|95.0|0.99|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.99|8.49
91510539|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.87|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor parents' perception of needs being met.||1.87|1.00|
91756073|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||86.21|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|86.21
91533643|NCT02857283|182944672|SUPERIORITY|||||||0.9|||||||ANOVA|paired||||||0.90
91533644|NCT02857283|182944674|SUPERIORITY|||||||0.64|||||||Wilcoxon signed rank test|||||||0.64
91533645|NCT02857283|182944675|SUPERIORITY|||||||0.79|||||||Wilcoxon signed rank test|||||||0.79
91533646|NCT02857283|182944676|SUPERIORITY|||||||0.094|||||||ANOVA|||||||0.094
91533647|NCT00961805|182944686|SUPERIORITY_OR_OTHER||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA|||"Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique."||||<0.001
91533648|NCT00961805|182944687|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
91533649|NCT00961805|182944688|SUPERIORITY_OR_OTHER||||||<|0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.003
91533650|NCT00961805|182944689|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.146
91533651|NCT00961805|182944690|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.131
91533652|NCT00961805|182944691|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
91533653|NCT00961805|182944692|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.580
91533654|NCT00961805|182944693|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.082
91533655|NCT00961805|182944694|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.055
91533656|NCT00961805|182944695|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.003
91756074|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||75.2|TWO_SIDED|95.0|0.98|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.98|75.20
91756075|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.29|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.29
91756076|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||71.08|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|71.08
91756077|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||34.93|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|34.93
91756078|NCT02294734|183404491|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.05|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|25.05
91756079|NCT02294734|183404492|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|28.51
91756080|NCT02294734|183404492|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.15|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|32.15
91756081|NCT02294734|183404492|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||66.51|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|66.51
91510540|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.83|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor parents' perception of needs being met.||1.53|0.83|
91510541|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.59|1.3|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor parents' perception of needs being met.||1.3|0.59|
91510542|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.9|1.29|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.29|0.9|
91510543|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.86|1.22||||||Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.22|0.86|
91513544|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.53||||0.3485|TWO_SIDED|95.0|-2.13|3.18|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||3.18|-2.13|0.3485
91533657|NCT00961805|182944696|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.021
91510544|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.7|1.13|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.13|0.7|
91756082|NCT02294734|183404492|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||45.28|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|45.28
91756083|NCT02294734|183404500|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.0||||0.487|TWO_SIDED|95.0|-118.5|115.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||115.3|-118.5|0.487
91756084|NCT02294734|183404500|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|60.6||||0.816|TWO_SIDED|95.0|-73.3|194.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||194.3|-73.3|0.816
91510545|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.9|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.31|0.9|
91510546|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.91|1.32|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.32|0.91|
91510547|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.24|0.76|
91756085|NCT02294734|183404503|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.144||||0.151|TWO_SIDED|95.0|-0.42|0.133|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.133|-0.420|0.151
91510548|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of physical therapy services.||1.15|.7|
91510549|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.74|1.48|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of physical therapy services.||1.48|.74|
91533658|NCT00961805|182944697|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.136
91533659|NCT00961805|182944698|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.009
91756086|NCT02294734|183404503|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.121||||0.712|TWO_SIDED|95.0|-0.305|0.551|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.551|-0.305|0.712
91756087|NCT02294734|183404504|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.18||||0.817|TWO_SIDED|95.0|-0.216|0.57|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.570|-0.216|0.817
91756088|NCT02294734|183404504|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.114||||0.697|TWO_SIDED|95.0|-0.324|0.549|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.549|-0.324|0.697
91756089|NCT02294734|183404507|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.171||||0.965|TWO_SIDED|95.0|0.988|1.388|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.388|0.988|0.965
91756090|NCT02294734|183404507|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.114||||0.913|TWO_SIDED|95.0|0.953|1.305|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.305|0.953|0.913
91759865|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.93|||||TWO_SIDED|95.0|-19.88|-5.98||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.98|-19.88|
91756091|NCT01943552|183404512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|154.9|STANDARD_ERROR_OF_MEAN|32.32|<|0.0001|TWO_SIDED|95.0|91.08|218.63|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of FEV1 from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||218.63|91.08|<0.0001
91756092|NCT01943552|183404513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|51.0|STANDARD_ERROR_OF_MEAN|54.48||0.3509|TWO_SIDED|95.0|-56.55|158.46|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||158.46|-56.55|0.3509
91756093|NCT01943552|183404514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|2.18||0.2069|TWO_SIDED|95.0|-1.54|7.07|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||7.07|-1.54|0.2069
91510550|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life -Self Care outcome for the predictor amount of occupational therapy.||1.21|.72|
91756094|NCT01943552|183404515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1899|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for Oxygen saturation between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||0.93|-0.19|0.1899
91510551|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of occupational therapy.||1.5|.89|
91533660|NCT00587288|182944700|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.194||0.0541|TWO_SIDED|95.0|-0.76|0.01||The p-value for the treatment comparison is based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.01|-0.76|0.0541
91533661|NCT00587288|182944701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0848|TWO_SIDED|95.0|0.91|4.46||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||4.46|0.91|0.0848
91533662|NCT00587288|182944702|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0023|TWO_SIDED|95.0|0.088|0.392||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.392|0.088|0.0023
91533663|NCT00587288|182944703|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.98|STANDARD_ERROR_OF_MEAN|2.36||0.001|TWO_SIDED|95.0|3.3|12.65||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||12.65|3.30|0.0010
91533664|NCT00587288|182944704|SUPERIORITY_OR_OTHER||Adjusted mean difference|-125.29|STANDARD_ERROR_OF_MEAN|44.885||0.0068|TWO_SIDED|95.0|-214.81|-35.77||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline. The difference between reslizumab 3.0 mg/kg and placebo groups was from comparison of the least square means.|ANCOVA|||||-35.77|-214.81|0.0068
91533665|NCT00587288|182944705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.0833|TWO_SIDED|95.0|0.1|1.15||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||1.15|0.10|0.0833
91756095|NCT01943552|183404516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4758|TWO_SIDED|95.0|-0.72|1.55|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaCO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||1.55|-0.72|0.4758
91756096|NCT01943552|183404517|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel Test Statistic|1.82||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||For main post-operative pulmonary complications, the Cochran-Mantel-Haenszel analysis was performed on the SCS. Mantel-Haenszel test with strata based on acute bronchodilator responsiveness at baseline and age was used to compare the number of patients with main post-operative pulmonary complications between the two arms.||||0.1779
91756097|NCT00545103|183404526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.778||95.0|||||Cochran-Mantel-Haenszel|||||||0.778
91756098|NCT00545103|183404526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159||95.0|||||Cochran-Mantel-Haenszel|||||||0.159
91756099|NCT00545103|183404526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.368||95.0|||||Cochran-Mantel-Haenszel|||||||0.368
91756100|NCT00545103|183404527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0|||||Cochran-Mantel-Haenszel|||||||0.685
91756101|NCT00545103|183404527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0|||||Cochran-Mantel-Haenszel|||||||0.198
91756102|NCT00545103|183404527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441||95.0|||||Cochran-Mantel-Haenszel|||||||0.441
91510552|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of occupational therapy.||1.38|.65|
91510553|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.81|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of speech and language therapy.||1.31|.81|
91510554|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.87|1.39|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of speech and language therapy.||1.39|.87|
91510555|NCT02391948|182892854|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.6|1.25|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of speech and language therapy.||1.25|.6|
91510556|NCT02391948|182892854|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of physical therapy services.||1.53|.92|
91510557|NCT02391948|182892858|OTHER||population average|2319.0|||||TWO_SIDED|95.0|1460.0|3218.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3218|1460|
91510558|NCT02391948|182892858|OTHER||population average|1858.0|||||TWO_SIDED|95.0|1233.0|2530.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||2530|1233|
91510559|NCT02391948|182892859|OTHER||population average|5240.0|||||TWO_SIDED|95.0|3874.0|6670.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||6670|3874|
91510560|NCT02391948|182892859|OTHER||population average|4319.0|||||TWO_SIDED|95.0|3258.0|5443.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||5443|3258|
91510561|NCT02391948|182892860|OTHER||population average|108.0|||||TWO_SIDED|95.0|67.0|151.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||151|67|
91510562|NCT02391948|182892860|OTHER||population average|100.0|||||TWO_SIDED|95.0|58.0|145.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||145|58|
91510563|NCT02391948|182892860|OTHER||population average|10.0|||||TWO_SIDED|95.0|0.0|35.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||35|0|
91510564|NCT02391948|182892861|OTHER||population average|2815.0|||||TWO_SIDED|95.0|2025.0|3650.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3650|2025|
91510565|NCT02391948|182892861|OTHER||population average|3109.0|||||TWO_SIDED|95.0|2502.0|3739.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3739|2502|
91510566|NCT02391948|182892861|OTHER||population average|1056.0|||||TWO_SIDED|95.0|471.0|1665.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||1665|471|
91510567|NCT02348489|182892865|SUPERIORITY||Difference in response rate (%)|1.92||||0.482|TWO_SIDED|96.0|-3.67|7.5|||Cochran-Mantel-Haenszel|||The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||7.5|-3.67|0.482
91510568|NCT02348489|182892866|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7328|TWO_SIDED|95.0|0.83|1.14|||Stratified log-rank|||Overall survival curves were estimated using Kaplan-Meier method and compared between the treatment groups using a 2-sided stratification log-rank test, stratified by the same factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||1.14|0.83|0.7328
91513545|NCT03029208|182898970|SUPERIORITY||LS mean difference|-1.49||||0.8064|TWO_SIDED|95.0|-4.87|1.9|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.90|-4.87|0.8064
91759866|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-10.03|3.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.83|-10.03|
91510569|NCT01969838|182892874|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.09||||0.014|TWO_SIDED|95.0|0.02|0.16|||Cochran-Mantel-Haenszel|||||0.16|0.02|0.014
91756103|NCT02358044|183404537|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||<|0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|||"Primary Analysis Approach: Non-Inferiority~Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided."||15.3|3.6|<0.001
91756104|NCT02358044|183404537|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentage|8.8||||0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.||"Secondary Analysis Approach: Superiority~Analyses of the percentage of participants achieving SVR12 was conducted using the M\&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided."||15.3|3.6|0.001
91756105|NCT02358044|183404538|SUPERIORITY_OR_OTHER||Difference in Percentage|-41.7|||||TWO_SIDED|95.0|-51.1|-31.9||||||The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.||-31.9|-51.1|
91510570|NCT01969838|182892875|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.0||||0.98|TWO_SIDED|95.0|-0.08|0.08|||Cochran-Mantel-Haenszel|||||0.08|-0.08|0.98
91510571|NCT01969838|182892876|SUPERIORITY||Rate ratio|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.43|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||0.43|0.19|<0.001
91510572|NCT01969838|182892877|SUPERIORITY||Proportion Difference - Stratified CMH|0.18|||<|0.001|TWO_SIDED|95.0|0.09|0.26|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.26|0.09|<0.001
91510573|NCT01969838|182892878|SUPERIORITY||Proportion Difference - Stratified CMH|-0.1||||0.019|TWO_SIDED|95.0|-0.19|-0.02|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||-0.02|-0.19|0.019
91510574|NCT00408993|182892879|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.|ANCOVA|Model=Treatment, Pooled Investigator and Baseline.||With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.||||0.617
91533666|NCT00587288|182944705|SUPERIORITY_OR_OTHER|||||||0.0809|||||||Log Rank|The p value for the treatment comparison was based on log rank test adjusting for stratification factor (ie, ACQ score ≤2 and \>2).||"Kaplan-Meier estimate of time to first CAE. (First quartile, median and third quartile survival times with 95% confidence intervals (ie, time to first CAE) could not be estimated since the proportion of patients experiencing CAE was too low. Therefore, the only number presented in regard to the Kaplan-Meier analysis is the p-value of the log-rank test, below. )"||||0.0809
91756106|NCT02358044|183404540|SUPERIORITY_OR_OTHER||Difference in Percentage|-27.0|||<|0.001|TWO_SIDED|95.0|-35.5|-19.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Total Tier 1 AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-19.6|-35.5|<0.001
91759867|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-17.06|-3.13||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.13|-17.06|
91510575|NCT00408993|182892880|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||P-value for Worst Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.070
91510576|NCT00408993|182892880|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value for Least Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.151
91510577|NCT00408993|182892880|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Pain Right Now Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.012
91510578|NCT00408993|182892880|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value for Average Interference Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.077
91510579|NCT00408993|182892881|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.036
91756107|NCT02358044|183404540|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.4||||0.078|TWO_SIDED|95.0|-6.8|0.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Serious drug-related AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||0.6|-6.8|0.078
91756108|NCT02358044|183404540|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.312|TWO_SIDED|95.0|-4.4|2.1||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"DC due to drug-related AE:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||2.1|-4.4|0.312
91533667|NCT00762463|182944707|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was \<10 mm.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.79||0.0085|TWO_SIDED|95.0|-2.2|8.8|||ANCOVA|Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient's Assessment of Global Pain Intensity score.||"Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was \<10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided)."||8.8|-2.2|0.0085
91533668|NCT00762463|182944709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.5||0.7849|TWO_SIDED|95.0|-5.6|4.2|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||4.2|-5.6|0.7849
91533669|NCT00762463|182944709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.62||0.3223|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.8|-2.6|0.3223
91533670|NCT00762463|182944711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8938|TWO_SIDED|95.0|-0.15|0.17|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.17|-0.15|0.8938
91533671|NCT00762463|182944711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0426|TWO_SIDED|95.0|0.01|0.31|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.31|0.01|0.0426
91533672|NCT00762463|182944711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1502|TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.29|-0.05|0.1502
91533673|NCT00762463|182944713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.5945|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.1|-0.2|0.5945
91533674|NCT00762463|182944713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3427|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.3427
91533675|NCT00762463|182944713|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6522|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.6522
91533676|NCT00762463|182944715|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9358|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.3|0.9358
91533677|NCT00762463|182944715|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5916|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.5916
91759868|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.67|||||TWO_SIDED|95.0|-17.57|-3.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.77|-17.57|
91759869|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.79|||||TWO_SIDED|95.0|-14.72|-0.86||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.86|-14.72|
91510580|NCT00408993|182892882|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-value for Visit 3|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.955
91510581|NCT00408993|182892882|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Visit 4|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.004
91510582|NCT00408993|182892882|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Visit 5|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.037
91510583|NCT00408993|182892882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Visit 6|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||<0.001
91510584|NCT00408993|182892882|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Visit 7|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.028
91510585|NCT00408993|182892883|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.207
91510586|NCT00408993|182892884|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
91510587|NCT00408993|182892886|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value for 5-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.364
91510588|NCT00408993|182892886|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value for 8-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.590
91510589|NCT00408993|182892887|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.620
91510590|NCT00408993|182892888|SUPERIORITY_OR_OTHER|||||||0.324||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.324
91510591|NCT00408993|182892889|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||P-value for Systolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.642
91510592|NCT00408993|182892889|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||P-value for Diastolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.601
91510593|NCT00408993|182892890|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Chloride|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.014
91510594|NCT00408993|182892890|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for High Density Lipoprotein Cholesterol|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.005
91510595|NCT00408993|182892890|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Sodium|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.011
91510596|NCT00408993|182892890|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for triglycerides|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.044
91510597|NCT00408993|182892891|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.||||||0.017
91510598|NCT04193202|182892892|SUPERIORITY||Estimated difference|0.75||||0.034|TWO_SIDED|95.0|0.06|1.44|||Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline LCQ total score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12|||1.44|0.06|0.034
91510599|NCT04193202|182892893|OTHER||Estimated Difference|-6.92||||0.006|TWO_SIDED|95.0|-11.88|-1.97||Nominal p value, not controlled for multiplicity|Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline mean weekly cough severity VAS score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12.|||-1.97|-11.88|0.006
91510600|NCT01777997|182892896|OTHER|||||||0.001|||||||Regression, repeated measures (GEE)|||Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.||||0.001
91510601|NCT04622254|182892911|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510602|NCT04622254|182892912|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510603|NCT04622254|182892913|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510604|NCT04622254|182892914|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510605|NCT04622254|182892915|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510606|NCT04622254|182892916|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510607|NCT04622254|182892917|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510608|NCT04622254|182892918|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510609|NCT04622254|182892919|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510610|NCT04622254|182892920|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91510611|NCT04622254|182892921|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510612|NCT04622254|182892922|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510613|NCT04622254|182892923|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510614|NCT04622254|182892923|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
91510615|NCT04622254|182892924|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91510616|NCT04622254|182892924|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91513546|NCT03029208|182898970|SUPERIORITY||LS mean difference|-1.29||||0.8687|TWO_SIDED|95.0|-3.57|0.98|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||0.98|-3.57|0.8687
91513547|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.71||||0.2435|TWO_SIDED|95.0|-1.29|2.7|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.70|-1.29|0.2435
91533678|NCT00762463|182944715|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.179|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.7|-0.1|0.1790
91756109|NCT02358044|183404540|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.7|||<|0.001|TWO_SIDED|95.0|-19.7|-8.0||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Neutrophil count \<0.75 x 10\^9/L:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-8.0|-19.7|<0.001
91756110|NCT02358044|183404540|SUPERIORITY_OR_OTHER||Difference in Percentage|-13.5|||<|0.001|TWO_SIDED|95.0|-20.8|-7.9||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Hemoglobin \<10 g/dL:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-7.9|-20.8|<0.001
91510617|NCT02652624|182892927|NON_INFERIORITY|A sample size of 470 participants (\~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in percentages|0.0|||||TWO_SIDED|95.001|-2.9|2.9|||||The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.9|-2.9|
91510618|NCT02652624|182892927|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91510619|NCT02652624|182892928|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in percentages|0.4|||||TWO_SIDED|95.001|-3.7|4.5|||||The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||4.5|-3.7|
91510620|NCT02652624|182892928|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91510621|NCT02652624|182892929|OTHER||Difference in least square means|3.0||||0.84|TWO_SIDED|95.0|-27.0|34.0|||ANOVA||Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.|||34|-27|0.84
91510622|NCT03228680|182892938|NON_INFERIORITY|The pre-specified non-inferiority (NI) margin was -3.0 oocytes. The NI was evaluated based on the two-sided 95% CI from the ANOVA on 'number of oocytes retrieved' with treatment and AMH stratum as fixed factors.|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||If the lower bound of 95% CI was well above pre-specified NI limit of -3.0 oocytes, then NI of FE 999049 to FOLLISTIM with respect to number of oocytes retrieved in women undergoing controlled ovarian stimulation would be demonstrated|Mean number of oocytes retrieved.||-0.1|-2.3|
91510623|NCT03228680|182892939|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-7.5|10.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer.||10.6|-7.5|
91510624|NCT03228680|182892940|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-9.5|9.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with positive beta-hCG.||9.6|-9.5|
91510625|NCT03228680|182892941|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-6.7|10.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with vital pregnancy.||10.8|-6.7|
91510626|NCT03228680|182892942|OTHER||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-8.9|12.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of implanted embryos 5-6 weeks after transfer.||12.8|-8.9|
91510627|NCT03228680|182892944|SUPERIORITY|||||||0.244||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with blastocyst transfer cancellation.||||0.244
91510628|NCT03228680|182892945|SUPERIORITY|||||||0.254||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \<4 oocytes retrieved (low response).||||0.254
91756111|NCT02358044|183404541|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||||TWO_SIDED|95.0|3.3|15.7||||||Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.||15.7|3.3|
91533679|NCT00762463|182944717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6335|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.6335
91533680|NCT00762463|182944717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2729|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.6|-0.2|0.2729
91533681|NCT00762463|182944717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1559|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.8|-0.1|0.1559
91533682|NCT00762463|182944720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.67||0.1111|TWO_SIDED|95.0|-1.0|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.0|0.1111
91533683|NCT00762463|182944720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.74||0.3574|TWO_SIDED|95.0|-2.9|7.9|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.9|-2.9|0.3574
91533684|NCT00762463|182944720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.76||0.1464|TWO_SIDED|95.0|-1.4|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.4|0.1464
91533685|NCT00762463|182944722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9641|TWO_SIDED|95.0|-1.7|1.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||1.8|-1.7|0.9641
91533686|NCT00762463|182944722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7749|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7749
91533687|NCT00762463|182944722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7529|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7529
91533688|NCT00762463|182944724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.878|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.2|0.8780
91533689|NCT00762463|182944724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2202|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.1|0.2202
91533690|NCT00762463|182944724|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.534|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.2|0.5340
91533691|NCT00762463|182944726|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.81||0.7003|TWO_SIDED|95.0|-4.3|2.9|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.9|-4.3|0.7003
91533692|NCT00762463|182944728|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|2.221||0.5183|TWO_SIDED|95.0|-5.82|2.94|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.94|-5.82|0.5183
91533693|NCT00531479|182944740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74||||0.0434|TWO_SIDED|95.0|-18.99|1.51||P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.|All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.||1.51|-18.99|0.0434
91533694|NCT00531479|182944741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.23|||||TWO_SIDED|95.0|-21.6|1.15||P-value for global response was to be reported only if Week 6 mortality was significant.|||95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.15|-21.6|
91756112|NCT00903331|183404548|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9631|TWO_SIDED|95.0|-0.09|0.08|||Wilcoxon Rank Sum|||The null hypothesis was that there was no difference between ACT-064922 and placebo for the change in FVC from baseline to the end of Period 1. The aim was to detect a placebo-corrected change in FVC of ≥ 0.1 L (Standard Deviation = 0.2 L) at a two-sided 0.05 type 1 error level and 80% power.||0.08|-0.09|0.9631
91533695|NCT00531479|182944742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2611|TWO_SIDED|95.0|-10.77|5.56||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||5.56|-10.77|0.2611
91533696|NCT00531479|182944743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.18||||0.0383|TWO_SIDED|95.0|-21.44|1.09||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence intervalbased on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.09|-21.44|0.0383
91533697|NCT00531479|182944744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.1029|TWO_SIDED|95.0|-15.9|3.42||P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||3.42|-15.9|0.1029
91533698|NCT00531479|182944745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.083|TWO_SIDED|95.0|0.46|1.04|||Cox proportional hazards model|||Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.||1.04|0.46|0.083
91533699|NCT00531479|182944746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.164|TWO_SIDED|95.0|0.4|1.16|||Cox proportional hazards model||95% confidence interval based on Greenwood's formula.|Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.||1.16|0.40|0.164
91533700|NCT01743729|182944754|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.03||||0.6186|TWO_SIDED|95.0|-0.1|0.17|||ANCOVA|||||0.17|-0.10|0.6186
91533701|NCT01743729|182944755|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|12.61|||<|0.0001|TWO_SIDED|95.0|8.51|16.7|||ANCOVA|||||16.70|8.51|<0.0001
91533702|NCT05074498|182944789|OTHER||Least square mean difference|-0.35||||0.0838|TWO_SIDED|95.0|-0.741|0.047|||Mixed Models Analysis|||||0.047|-0.741|0.0838
91533703|NCT01306331|182944824|NON_INFERIORITY|If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.2|3.2||||||The primary hypothesis test was performed using 95% confidence interval for the difference in cumulative pregnancy rates between the treatment arms. If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.||3.2|-2.2|
91533704|NCT03371108|182944827|EQUIVALENCE|The determination of equivalence was defined by the US-FDA as a confidence interval that was contained within the equivalence limits of +/- 10.7.|Risk Difference (RD)|-2.1|STANDARD_ERROR_OF_MEAN|3.39|||TWO_SIDED|90.0|-7.6|3.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||3.5|-7.6|
91533705|NCT01677936|182944839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||=|0.024||||||Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.024
91756113|NCT00903331|183404549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118||||0.7056|TWO_SIDED|95.0|0.626|1.996|||Log Rank|||||1.996|0.626|0.7056
91533706|NCT01677936|182944840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||=|0.035||||||Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.035
91756114|NCT03233438|183404568|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.5||0.003|TWO_SIDED|95.0|0.6|2.6|||t-test, 2 sided|||||2.6|0.6|0.003
91756115|NCT03233438|183404569|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.56||0.003|TWO_SIDED|95.0|0.6|2.8|||t-test, 2 sided|||||2.8|0.6|0.003
91756116|NCT02219503|183404609|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|94.0|
91756117|NCT02219503|183404609|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.||100.0|94.0|
91756118|NCT03249103|183404612|OTHER|||||||0.032|||||||t-test, 2 sided|||placebo - NYX-2925 20 mg||||0.032
91756119|NCT03249103|183404613|OTHER|||||||0.039|||||||t-test, 2 sided|||placebo - NYX-2925 200 mg||||0.039
91756120|NCT03249103|183404614|OTHER|||||||0.0072|||||||t-test, 2 sided|comparing Week 2 (Placebo) to Week 6 (NYX-2925 200 mg)||||||0.0072
91533707|NCT02790606|182944846|SUPERIORITY|||||||0.0021|||||||Exact binomial test|||"The primary safety endpoint is evaluated against a PG of 88%, which was derived from safety event rates of PTA in published literature.~Hypothesis: The safety rate in subjects treated with the COVERA™ Vascular Covered Stent (following PTA) at 30 days post-index procedure is greater than that of the PG of 88%. 109 treated subjects \[104 evaluable\] will give 99% power with one-sided type I error = 0.05."||||0.0021
91756121|NCT00257660|183404617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.84|||<|0.0001|TWO_SIDED|95.0|-12.94|-4.74||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.74|-12.94|<0.0001
91756122|NCT00257660|183404618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.81|||<|0.0001||95.0|-12.91|-4.71||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.71|-12.91|<0.0001
91756123|NCT00257660|183404619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.12||||0.019||95.0|-7.55|-0.68||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-0.68|-7.55|0.019
91510629|NCT03228680|182892945|SUPERIORITY|||||||0.041||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 4-7 oocytes retrieved (moderate response).||||0.041
91510630|NCT03228680|182892945|SUPERIORITY|||||||0.705||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 8-14 oocytes retrieved (targeted response).||||0.705
91510631|NCT03228680|182892945|SUPERIORITY|||||||0.183||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 15-19 oocytes retrieved (hyperresponse).||||0.183
91510632|NCT03228680|182892945|SUPERIORITY|||||||0.03||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \>= (more than equal to) 20 oocytes retrieved (severe hyperresponse).||||0.030
91756124|NCT00257660|183404620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.2|||<|0.001||95.0|-24.0|-6.4||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.4|-24.0|<0.001
91756125|NCT00257660|183404621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.2|||<|0.001||95.0|-22.3|-6.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.1|-22.3|<0.001
91510633|NCT03228680|182892946|SUPERIORITY|||||||0.893||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \< 15 pmol/L (\<4 oocytes retrieved)||||0.893
91510634|NCT03228680|182892946|SUPERIORITY|||||||0.002||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=15 oocytes retrieved)||||0.002
91510635|NCT03228680|182892946|SUPERIORITY|||||||0.021||||||P-value based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=20 oocytes retrieved)||||0.021
91510636|NCT03228680|182892948|SUPERIORITY|||||||0.017||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with early OHSS (any grade).||||0.017
91510637|NCT03228680|182892948|SUPERIORITY|||||||0.035||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe).||||0.035
91510638|NCT03228680|182892948|SUPERIORITY|||||||0.006||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (any grade) and/or preventive interventions.||||0.006
91510639|NCT03228680|182892948|SUPERIORITY|||||||0.009||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions.||||0.009
91759870|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||||TWO_SIDED|95.0|-9.98|3.89||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-9.98|
91756126|NCT00257660|183404622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.95|||<|0.001||95.0|-25.8|-8.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-8.1|-25.8|<0.001
91510640|NCT03228680|182892949|SUPERIORITY|||||||0.968||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (any grade).||||0.968
91510641|NCT03228680|182892949|SUPERIORITY|||||||0.582||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (moderate/severe).||||0.582
91510642|NCT03228680|182892950|SUPERIORITY|||||||0.198||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles on stimulation Day 6 was analyzed.||||0.198
91510643|NCT03228680|182892951|SUPERIORITY|||||||0.036||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles at end-of-stimulation was analyzed.||||0.036
91510644|NCT03228680|182892952|SUPERIORITY|||||||0.592||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.592
91510645|NCT03228680|182892953|SUPERIORITY|||||||0.286||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.286
91510646|NCT03228680|182892954|SUPERIORITY|||||||0.395||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The fertilization rate (number of oocytes with 2 pronuclei divided by the number of oocytes retrieved) was analyzed.||||0.395
91510647|NCT03228680|182892955|SUPERIORITY|||||||0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of embryos on Day 3 was analyzed.||||0.001
91510648|NCT03228680|182892955|SUPERIORITY|||||||0.004||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality embryos on Day 3 was analyzed.||||0.004
91510649|NCT03228680|182892956|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of blastocysts on Day 5 was analyzed.||||<.001
91510650|NCT03228680|182892956|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality blastocysts on Day 5 was analyzed.||||<0.001
91756127|NCT00257660|183404623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.0|||<|0.001||95.0|-24.2|-7.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-7.8|-24.2|<0.001
91759871|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.27|-6.54||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.54|-20.27|
91510651|NCT03228680|182892957|SUPERIORITY||Mean ratio|1.03||||0.228|TWO_SIDED|95.0|0.98|1.09||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH on stimulation Day 6.||1.09|0.98|0.228
91510652|NCT03228680|182892957|SUPERIORITY||Mean ratio|0.97||||0.777|TWO_SIDED|95.0|0.81|1.17||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH on stimulation Day 6.||1.17|0.81|0.777
91510653|NCT03228680|182892958|SUPERIORITY||Mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.84|0.94||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH at end-of-stimulation.||0.94|0.84|<0.001
91510654|NCT03228680|182892958|SUPERIORITY||Mean ratio|1.17||||0.057|TWO_SIDED|95.0|1.0|1.39||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH at end-of-stimulation.||1.39|1.00|0.057
91510655|NCT03228680|182892959|SUPERIORITY||Mean ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol on stimulation Day 6.||0.93|0.71|0.002
91510656|NCT03228680|182892960|SUPERIORITY||Mean ratio|0.85||||0.003|TWO_SIDED|95.0|0.76|0.95||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol at end-of-stimulation.||0.95|0.76|0.003
91513548|NCT03029208|182898970|SUPERIORITY||LS mean difference|-0.87||||0.7747|TWO_SIDED|95.0|-3.15|1.41|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.41|-3.15|0.7747
91510657|NCT03228680|182892961|SUPERIORITY||Mean ratio|1.02||||0.814|TWO_SIDED|95.0|0.89|1.16||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone on stimulation Day 6.||1.16|0.89|0.814
91756128|NCT00257660|183404624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.05||||0.007||95.0|-19.0|-3.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-3.1|-19.0|0.007
91510658|NCT03228680|182892962|SUPERIORITY||Mean ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.68|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone levels at end-of-stimulation.||0.88|0.68|<0.001
91756129|NCT00257660|183404625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.05||||0.028||95.0|-13.3|-0.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-0.8|-13.3|0.028
91756130|NCT00257660|183404626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.65||||0.061||95.0|-0.17|7.47||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.47|-0.17|0.061
91510659|NCT03228680|182892963|SUPERIORITY||Mean ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A on stimulation Day 6.||0.92|0.73|<0.001
91510660|NCT03228680|182892964|SUPERIORITY||Mean ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.72|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A at end-of-stimulation.||0.88|0.72|<0.001
91510661|NCT03228680|182892965|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B on stimulation Day 6.||0.93|0.75|<0.001
91510662|NCT03228680|182892966|SUPERIORITY||Mean ratio|0.88||||0.027|TWO_SIDED|95.0|0.79|0.99||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B at end-of-stimulation.||0.99|0.79|0.027
91510663|NCT03228680|182892967|SUPERIORITY|||||||0.694||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of stimulation days at end-of-stimulation.||||0.694
91510664|NCT03732638|182892990|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0099|TWO_SIDED|95.0|-1.46|-0.2|||Mixed Models Analysis|||||-0.20|-1.46|0.0099
91510665|NCT03732638|182892991|SUPERIORITY||Risk Difference (RD)|7.6||||0.0438|TWO_SIDED|95.0|0.2|14.9|||Cochran-Mantel-Haenszel|||||14.9|0.2|0.0438
91510666|NCT03732638|182892992|SUPERIORITY||Mean Difference (Net)|-0.8||||0.0017|TWO_SIDED|95.0|-1.34|-0.31|||Mixed Models Analysis|||||-0.31|-1.34|0.0017
91510667|NCT03732638|182892993|SUPERIORITY||Mean Difference (Net)|-0.2||||0.3868|TWO_SIDED|95.0|-0.8|0.31||P-value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Mixed Models Analysis|||||0.31|-0.80|0.3868
91510668|NCT03192150|182893011|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.|||||<|0.0001||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with ACC Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||< 0.0001
91510669|NCT03192150|182893012|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.311||||0.0054|TWO_SIDED|95.0|1.311|4.074||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||4.074|1.311|0.0054
91510670|NCT03192150|182893012|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.581|||<|0.0001|TWO_SIDED|95.0|1.967|6.519||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||6.519|1.967|< 0.0001
91510671|NCT03192150|182893012|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.503|||<|0.0001|TWO_SIDED|95.0|1.909|6.426||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||6.426|1.909|< 0.0001
91510672|NCT03192150|182893012|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.659|||<|0.0001|TWO_SIDED|95.0|1.987|6.736||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||6.736|1.987|< 0.0001
91510673|NCT03192150|182893012|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.952||||0.0008|TWO_SIDED|95.0|1.596|5.462||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||5.462|1.596|0.0008
91510674|NCT01420302|182893015|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91510675|NCT02214147|182893051|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|1.12|1.8|||||Least Squares Geometric Means Ratio= Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||1.80|1.12|
91510676|NCT02214147|182893052|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|3.21|||||TWO_SIDED|90.0|2.33|4.43|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||4.43|2.33|
91756131|NCT00257660|183404627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.66||||0.002||95.0|1.73|7.58||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.58|1.73|0.002
91756132|NCT00257660|183404628|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.206|||<|0.0001||95.0|3.01|17.26||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|odds ratio|The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country||The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.||17.26|3.01|<0.0001
91756133|NCT02025439|183404645|OTHER||Mean Difference (Final Values)|0.071|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91756134|NCT03426631|183404715|SUPERIORITY||Median Difference (Final Values)|-11.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.47
91756135|NCT00454181|183404716|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.||||0.30
91756136|NCT00454181|183404717|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response||||0.26
91756137|NCT00454181|183404718|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as better."||||0.50
91756138|NCT00454181|183404719|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as better."||||0.29
91756139|NCT00454181|183404720|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with respect to changes in oral warts from baseline to week 24 by the attending investigator."||||0.74
91756140|NCT00454181|183404721|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with resepect to changes from baseline to week 24 in global oral health by the attending investigator."||||.71
91756141|NCT02096263|183404724|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.1|||||TWO_SIDED|95.0|0.92|1.31|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.||1.31|0.92|
91756142|NCT02096263|183404724|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.||1.35|0.97|
91756143|NCT02096263|183404724|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.||0.99|0.63|
91756144|NCT01571453|183404767|NON_INFERIORITY_OR_EQUIVALENCE|Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.93||0.199||95.0|-3.03|0.63||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.||0.63|-3.03|0.199
91510677|NCT02214147|182893053|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|2.54|||||TWO_SIDED|90.0|1.84|3.53|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||3.53|1.84|
91510678|NCT05446909|182893065|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
91510679|NCT05446909|182893066|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
91510680|NCT05446909|182893067|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
91510681|NCT05446909|182893068|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91510682|NCT05446909|182893069|SUPERIORITY|||||||0.754|||||||ANOVA|||||||0.754
91510683|NCT05446909|182893070|SUPERIORITY|||||||0.985|||||||ANOVA|||||||0.985
91510684|NCT05446909|182893071|SUPERIORITY|||||||0.877|||||||ANOVA|||||||0.877
91510685|NCT03759223|182893072|SUPERIORITY|||||||0.04||||||0:24 weeks|Mixed Models Analysis|||||||.04
91510686|NCT03759223|182893072|SUPERIORITY|||||||0.05||||||0:24 weeks|Mixed Models Analysis|||||||.05
91510687|NCT03759223|182893072|SUPERIORITY|||||||0.58||||||12:12 weeks|Mixed Models Analysis|||||||.58
91510688|NCT05421078|182893085|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
91510689|NCT05421078|182893085|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
91510690|NCT05421078|182893085|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
91510691|NCT05421078|182893086|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||p value is calculated||-15.14|-36.53|<.0001
91510692|NCT05421078|182893086|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
91510693|NCT05421078|182893086|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
91510694|NCT05421078|182893087|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
91510695|NCT05421078|182893087|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
91510696|NCT05421078|182893087|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
91510697|NCT05421078|182893088|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
91510698|NCT05421078|182893088|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
91510699|NCT05421078|182893088|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
91510700|NCT05421078|182893089|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
91510701|NCT05421078|182893089|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
91510702|NCT05421078|182893089|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
91510703|NCT05421078|182893090|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
91756145|NCT01571453|183404768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.228|TWO_SIDED|95.0|-0.39|0.09||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.09|-0.39|0.228
91510704|NCT05421078|182893090|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
91510705|NCT05421078|182893090|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
91510706|NCT05421078|182893091|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
91510707|NCT05421078|182893091|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
91510708|NCT05421078|182893091|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
91510709|NCT05421078|182893092|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
91510710|NCT05421078|182893092|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
91510711|NCT05421078|182893092|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
91510712|NCT05421078|182893093|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
91510713|NCT05421078|182893093|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
91510714|NCT05421078|182893093|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
91510715|NCT05421078|182893094|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|||||-14.31|-33.56|<.0001
91510716|NCT05421078|182893094|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
91510717|NCT05421078|182893094|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
91510718|NCT05421078|182893095|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
91510719|NCT05421078|182893095|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
91510720|NCT05421078|182893095|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
91510721|NCT05421078|182893096|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
91510722|NCT05421078|182893096|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
91510723|NCT05421078|182893096|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
91510724|NCT05421078|182893097|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
91510725|NCT05421078|182893097|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
91510726|NCT05421078|182893097|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
91510727|NCT05421078|182893098|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
91756146|NCT01571453|183404769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.174|TWO_SIDED|95.0|-0.35|0.06||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.06|-0.35|0.174
91756147|NCT01571453|183404770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.65||0.207|TWO_SIDED|95.0|-2.09|0.45||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.45|-2.09|0.207
91510728|NCT05421078|182893098|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
91510729|NCT05421078|182893098|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
91510730|NCT05421078|182893099|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
91510731|NCT05421078|182893099|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
91510732|NCT05421078|182893099|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
91510733|NCT05944250|182893159|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
91510734|NCT05944250|182893163|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 1||||1
91510735|NCT05944250|182893163|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 2||||1
91510736|NCT05944250|182893163|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 3||||1
91510737|NCT05944250|182893163|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 4||||0.15
91510738|NCT05944250|182893164|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 1||||1
91510739|NCT05944250|182893164|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 2||||1
91510740|NCT05944250|182893164|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 3||||0.59
91510741|NCT05944250|182893164|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 4||||0.09
91510742|NCT00086580|182893165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.467|0.795|||Regression, Cox|Cox proportional hazards model was stratified by Rai Stage Group||||0.795|0.467|<0.001
91510743|NCT00086580|182893166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.178|TWO_SIDED|95.0|-0.03|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of Overall Response.||0.15|-0.03|0.178
91510744|NCT00086580|182893166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.018|TWO_SIDED|95.0|0.02|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of complete response (CR).||0.15|0.02|0.018
91510745|NCT00086580|182893167|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.648||||0.042|TWO_SIDED|95.0|0.449|0.937||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group||||0.937|0.449|0.042
91510746|NCT00086580|182893168|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.562|||<|0.001|TWO_SIDED|95.0|0.42|0.752|||Regression, Cox|Cox regression model stratified by Rai Stage Group.||||0.752|0.420|<0.001
91510747|NCT00086580|182893170|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.718||||0.021|TWO_SIDED|95.0|0.543|0.951|||Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group.||||0.951|0.543|0.021
91510748|NCT00086580|182893178|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.102|TWO_SIDED|95.0|0.531|1.059|||Regression, Cox|||||1.059|0.531|0.102
91510749|NCT00086580|182893179|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.443|||<|0.001|TWO_SIDED|95.0|0.292|0.671|||Regression, Cox|||||0.671|0.292|<0.001
91510750|NCT00086580|182893180|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.066||||0.819|TWO_SIDED|95.0|0.619|1.836|||Regression, Cox|Cox proportional hazards model||||1.836|0.619|0.819
91510751|NCT00086580|182893181|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.416|||<|0.001|TWO_SIDED|95.0|0.25|0.69|||Regression, Cox|Cox proportional hazards model||||0.690|0.250|<0.001
91510752|NCT00086580|182893184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.014|TWO_SIDED|95.0|0.01|0.08|||Cochran-Mantel-Haenszel|CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.||||0.08|0.01|0.014
91756148|NCT01571453|183404771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.272||95.0|0.84|1.86||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.86|0.84|0.272
91756149|NCT01571453|183404772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.731||95.0|0.73|1.58||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.58|0.73|0.731
91759872|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.61|||||TWO_SIDED|95.0|1.62|17.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.61|1.62|
91756150|NCT01325714|183404774|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.71||||0.13|TWO_SIDED|95.0|0.45|1.11||This is the p value from the discrete-time Cox regression time-to-event analyses|Regression, Cox|DF = 1|The enhanced usual care arm is the comparison group.|"Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm."||1.11|0.45|0.13
91756151|NCT01325714|183404774|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.77||||0.39|TWO_SIDED|95.0|0.43|1.39||From discrete time-cox regression time-to-event analysis.|Regression, Cox|df = 1|The enhanced usual care arm is the reference group.|Comparison of incidence of non-verbal aggression between treatment groups.||1.39|0.43|0.39
91756152|NCT01325714|183404774|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset (the primary outcome) over a 1-year period, assuming 80% power and type I error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group (anticipated based on estimated rates from prior work) versus 19% for the treatment group|Hazard Ratio (HR)|0.84||||0.84|TWO_SIDED|95.0|0.51|1.37||From discrete-time Cox regression time-to-event analyses|Regression, Cox|df = 1|The usual care arm is the reference group.|Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.||1.37|0.51|0.84
91756153|NCT01325714|183404775|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.46|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 0.86||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.46
91510753|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Percentage of participants|29.0|||||TWO_SIDED|90.0|17.2|43.3|||||The estimated value represents the percentage of participants with CR and PR.|||43.3|17.2|
91510754|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Percentage of participants|45.0|||||TWO_SIDED|90.0|30.9|59.3|||||The estimated value represents the percentage of participants with CR and PR.|||59.3|30.9|
91510755|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Percentage of participants|47.0|||<|0.001|TWO_SIDED|90.0|32.8|62.1||Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.|||62.1|32.8|<0.001
91510756|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Percentage of participants|31.0|||||TWO_SIDED|90.0|11.3|57.3|||||The estimated value represents the percentage of participants with CR and PR.|||57.3|11.3|
91510757|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Percentage of participants|58.0|||<|0.001|TWO_SIDED|90.0|43.3|71.5||Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.|||71.5|43.3|<0.001
91510758|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.485|TWO_SIDED|90.0|-8.3|29.7|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||29.7|-8.3|0.485
91510759|NCT00558103|182893201|SUPERIORITY_OR_OTHER||Difference in percentage of participants|27.0||||0.116|TWO_SIDED|90.0|2.3|52.0|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||52.0|2.3|0.116
91510760|NCT00308711|182893205|SUPERIORITY_OR_OTHER||Kaplan-Meier|1595.5||||0.974||||||The a priori threshold for statistical significance was 0.05.|Log Rank||This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.|Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.||||0.974
91510761|NCT00308711|182893205|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1977.0||||0.011||95.0|1977.0|2253.0|||Log Rank|||||2253|1977|0.011
91510762|NCT00308711|182893206|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).|Cox Proportional Hazard|27.8||||0.64||95.0|23.61|32.31|||Fisher Exact|||||32.31|23.61|0.64
91510763|NCT00308711|182893206|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.|Cox Proportional Hazard|28.0||||0.59||95.0|23.86|32.42|||Fisher Exact|||||32.42|23.86|0.59
91756154|NCT01325714|183404776|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.43||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.23
91510764|NCT01556204|182893214|SUPERIORITY_OR_OTHER|||||||0.71||||||This p-value is from a single comparison between two arms for operative time.|t-test, 2 sided|||Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.||||0.71
91510765|NCT01556204|182893215|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: Baseline|Mixed Models Analysis|||Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.||||0.53
91510766|NCT01556204|182893215|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: 6-weeks|Mixed Models Analysis|||Pain scores at 6 weeks comparison between robotic and laparoscopy.||||0.53
91510767|NCT01556204|182893215|SUPERIORITY_OR_OTHER|||||||0.48||||||This applies to Row title: 6-months|Mixed Models Analysis|||Pain scores at 6 months for robotic vs laparoscopy.||||0.48
91510768|NCT04590495|182893223|SUPERIORITY|||||||0.946|||||||Mann Whitney U Test|||||||0.9460
91510769|NCT04590495|182893224|SUPERIORITY|||||||0.5699|||||||Mann Whitney U Test|||||||0.5699
91510770|NCT04590495|182893225|SUPERIORITY|||||||0.6068|||||||t-test, 2 sided|||||||0.6068
91510771|NCT04590495|182893226|SUPERIORITY|||||||0.903|||||||Mann Whitney U Test|||||||0.9030
91510772|NCT04590495|182893227|SUPERIORITY|||||||0.2668|||||||t-test, 2 sided|||||||0.2668
91510773|NCT04590495|182893228|SUPERIORITY|||||||0.8749||||||adjusted for baseline VAMS score|paired t test|||||||0.8749
91510774|NCT04590495|182893229|SUPERIORITY|||||||0.7922||||||adjusted for baseline VAMS score for physical sedation|paired t test|||||||0.7922
91510775|NCT04590495|182893230|SUPERIORITY|||||||0.9925||||||adjusted for baseline SSS score|paired t test|||||||0.9925
91510776|NCT04590495|182893231|SUPERIORITY|||||||0.2628||||||adjusted for baseline score|paired t test|||||||0.2628
91510777|NCT04590495|182893232|SUPERIORITY|||||||0.0347||||||adjusted for baseline scores|paired t test|||||||0.0347
91510778|NCT04590495|182893233|SUPERIORITY|||||||0.6331||||||adjusted for baseline score|paired t test|||||||0.6331
91510779|NCT04590495|182893234|SUPERIORITY|||||||0.472||||||adjusted for baseline score|paired t test|||||||0.4720
91510780|NCT04590495|182893235|SUPERIORITY|||||||0.02||||||adjusted for baseline reaction time|paired t test|||||||0.0200
91510781|NCT04590495|182893236|SUPERIORITY|||||||0.062||||||adjusted for baseline reaction time|paired t test|||||||0.0620
91510782|NCT02318693|182893240|SUPERIORITY_OR_OTHER||LS Means Difference|-8.8||||0.245|TWO_SIDED|95.0|-23.8|6.2|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||6.2|-23.8|0.245
91510783|NCT02318693|182893241|SUPERIORITY_OR_OTHER||LS Means Difference|-5.9||||0.029|TWO_SIDED|95.0|-11.3|-0.6|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.6|-11.3|0.029
91510784|NCT02318693|182893242|SUPERIORITY_OR_OTHER||LS Means Difference|-12.8||||0.041|TWO_SIDED|95.0|-25.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-25.1|0.041
91510785|NCT02318693|182893242|SUPERIORITY_OR_OTHER||LS Means Difference|-14.3||||0.043|TWO_SIDED|95.0|-28.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-28.1|0.043
91510786|NCT02318693|182893242|SUPERIORITY_OR_OTHER||LS Means Difference|5.1||||0.509|TWO_SIDED|95.0|-10.3|20.4|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.||20.4|-10.3|0.509
91510787|NCT02318693|182893243|SUPERIORITY_OR_OTHER||LS Means Difference|15.7||||0.02|TWO_SIDED|95.0|2.5|28.8|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||28.8|2.5|0.020
91510788|NCT02318693|182893244|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1||||0.134|TWO_SIDED|95.0|-2.5|0.3|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.3|-2.5|0.134
91510789|NCT02318693|182893244|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.226|TWO_SIDED|95.0|-1.5|0.4|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.4|-1.5|0.226
91510790|NCT02318693|182893244|SUPERIORITY_OR_OTHER||LS Means Difference|0.0||||0.332|TWO_SIDED|95.0|-0.1|0.0|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.0|-0.1|0.332
91510791|NCT02915744|182893255|OTHER||ESMO-MCBS (v1.0)|1.0|||||TWO_SIDED|||||||||||||
91756155|NCT01325714|183404777|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.45||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 1.45||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.||||0.23
91756156|NCT01325714|183404778|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.62|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 409) = 0.59||Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.||||0.62
91510792|NCT03591575|182893257|SUPERIORITY|||||||0.0446|||||||Fisher Exact|||Patients who reached the serum ferritin threshold at any time point prior to Month 12 were withdrawn from the study as per protocol, so that they could begin on standard chelation therapy. For these individuals, imputed data were used to estimate the values that would likely have been seen at Month 12 had they remained in the study.||||0.0446
91756157|NCT01325714|183404779|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.94||||0.42|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 453) = 0.94.||Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.||||0.42
91756158|NCT01325714|183404780|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.1||||0.35|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 457) = 1.10||Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.||||0.35
91756159|NCT01325714|183404781|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.11||||0.11|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 2.00||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.||||0.11
91756160|NCT01325714|183404782|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|3.84||||0.01|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 3.84||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.||||0.01
91756161|NCT00721175|183404783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2407407|STANDARD_ERROR_OF_MEAN|0.0920078||0.011|TWO_SIDED|95.0|-0.4210726|-0.0604089|||Two-sample test of proportion|||||-.0604089|-.4210726|0.011
91756162|NCT00721175|183404784|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Log Rank|||||||0.0021
91756163|NCT00721175|183404786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278744|STANDARD_ERROR_OF_MEAN|0.0929622||0.004|TWO_SIDED|95.0|-0.4609466|-0.0965414|||Two-sample test of proportion|||||-.0965414|-.4609466|0.004
91756164|NCT03109184|183404792|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED||||||||3-Month follow-up between groups odds ratio of DV perpetration|||||
91756165|NCT03109184|183404792|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED||||||||9-month follow-up between group odds ratio of DV perpetration|||||
91510793|NCT03591575|182893258|SUPERIORITY|||||||0.0446||||||he p-value shown here is for the difference between the groups at Month 12.|Fisher Exact|||||||0.0446
91510794|NCT00813358|182893259|NON_INFERIORITY|NI=7%|KM product-limit estimator|99.1|||||TWO_SIDED|95.0|97.4|100.0||||||||100|97.4|
91510795|NCT04011475|182893278|OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
91756166|NCT03109184|183404792|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED||||||||3-month follow-up between groups odds ratio of DV victimization|||||
91756167|NCT03109184|183404792|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED||||||||9-month follow-up between groups odds ratio of DV victimization|||||
91756168|NCT03109184|183404793|SUPERIORITY||Effect Size (d)|-0.07|||||TWO_SIDED||||||||3-month follow-up between groups effect size of general aggression|||||
91756169|NCT03109184|183404793|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of general aggression|||||
91756170|NCT03109184|183404794|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent attitudes support aggression|||||
91756171|NCT03109184|183404794|SUPERIORITY||Effect Size (d)|-0.17|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent attitudes support aggression|||||
91756172|NCT03109184|183404794|SUPERIORITY||Effect Size (d)|0.19|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent attitudes support aggression|||||
91756173|NCT03109184|183404794|SUPERIORITY||Effect Size (d)|0.2|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent attitudes support aggression|||||
91756174|NCT03109184|183404795|SUPERIORITY||Effect Size (d)|0.09|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent short-term self-regulation|||||
91756175|NCT03109184|183404795|SUPERIORITY||Effect Size (d)|0.36|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent short-term self-regulation|||||
91756176|NCT03109184|183404795|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent long-term self-regulation|||||
91756177|NCT03109184|183404795|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent long-term self-regulation|||||
91756178|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported open family communication|||||
91756179|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported open family communication|||||
91756180|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported problems in family communication|||||
91756181|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported problems in family communication|||||
91756182|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.62|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
91756183|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.13|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
91756184|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported open family communication|||||
91756185|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported open family communication|||||
91756186|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported problems in family communication|||||
91756187|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.25|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported problems in family communication|||||
91756188|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|0.66|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
91756189|NCT03109184|183404796|SUPERIORITY||Effect Size (d)|-0.1|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
91510796|NCT04011475|182893278|OTHER||Hazard Ratio (HR)|0.875||||0.6665|TWO_SIDED|95.0|0.47|1.604|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group B using group B as reference.|||1.604|0.47|0.6665
91510797|NCT04011475|182893278|OTHER||Hazard Ratio (HR)|2.377||||0.031|TWO_SIDED|95.0|1.083|5.221|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group C using group C as reference.|||5.221|1.083|0.0310
91510798|NCT04011475|182893278|OTHER||Hazard Ratio (HR)|2.716||||0.0116|TWO_SIDED|95.0|1.25|5.901|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group B versus group C using group C as reference.|||5.901|1.250|0.0116
91510799|NCT04011475|182893279|OTHER||Rate ratio|0.67||||0.0756|TWO_SIDED|95.0|0.43|1.04|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.04|0.43|0.0756
91510800|NCT04011475|182893279|OTHER||Rate ratio|4.36|||<|0.0001|TWO_SIDED|95.0|2.27|8.4|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||8.40|2.27|< 0.0001
91510801|NCT04011475|182893279|OTHER||Rate ratio|0.34||||0.0022|TWO_SIDED|95.0|0.17|0.68|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.68|0.17|0.0022
91510802|NCT04011475|182893280|OTHER||Rate ratio|1.25||||0.7394|TWO_SIDED|95.0|0.34|4.65|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||4.65|0.34|0.7394
91510803|NCT04011475|182893281|OTHER||Rate ratio|0.65||||0.1116|TWO_SIDED|95.0|0.38|1.11|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.11|0.38|0.1116
91510804|NCT04011475|182893281|OTHER||Rate ratio|3.78||||0.0004|TWO_SIDED|95.0|1.81|7.88|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||7.88|1.81|0.0004
91510805|NCT04011475|182893281|OTHER||Rate ratio|0.41||||0.0239|TWO_SIDED|95.0|0.19|0.89|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.89|0.19|0.0239
91510806|NCT04011475|182893282|OTHER||Rate ratio|0.71||||0.4164|TWO_SIDED|95.0|0.32|1.61|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.61|0.32|0.4164
91510807|NCT04011475|182893282|OTHER||Rate ratio|7.0||||0.01|TWO_SIDED|95.0|1.59|30.8|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||30.8|1.59|0.0100
91510808|NCT04011475|182893282|OTHER||Rate ratio|0.2||||0.0377|TWO_SIDED|95.0|0.04|0.91|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.91|0.04|0.0377
91510809|NCT04011475|182893283|OTHER|||||||0.2035|||||||Log Rank|||||||0.2035
91510810|NCT04011475|182893284|OTHER|||||||0.1858|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.1858
91510811|NCT04011475|182893285|OTHER|||||||0.0144|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0144
91510812|NCT04011475|182893285|OTHER|||||||0.9219|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9219
91510813|NCT04011475|182893285|OTHER|||||||0.959|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9590
91510814|NCT04011475|182893286|OTHER|||||||0.2909|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2909
91510815|NCT04011475|182893286|OTHER|||||||0.1618|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.1618
91510816|NCT04011475|182893286|OTHER|||||||0.4695|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.4695
91510817|NCT04011475|182893287|OTHER||||||>|0.9999|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||> 0.9999
91510818|NCT04011475|182893287|OTHER|||||||0.2516|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2516
91510819|NCT04011475|182893287|OTHER|||||||0.0036|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0036
91510820|NCT04011475|182893288|OTHER|||||||0.6189|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.6189
91510821|NCT04011475|182893288|OTHER|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.7656
91510822|NCT04011475|182893288|OTHER|||||||0.3594|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.3594
91510823|NCT04011475|182893289|OTHER|||||||0.0483|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.0483
91510824|NCT00600821|182893290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.639|TWO_SIDED|95.0|0.679|1.761||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.761|0.679|0.639
91510825|NCT00600821|182893291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.117||||0.699|TWO_SIDED|95.0|0.739|1.689||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.689|0.739|0.699
91756190|NCT03109184|183404797|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent emotion-regulation|||||
91756191|NCT03109184|183404797|SUPERIORITY||Effect Size (d)|0.32|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent emotion-regulation|||||
91756192|NCT03109184|183404798|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent distress tolerance|||||
91756193|NCT03109184|183404798|SUPERIORITY||Effect Size (d)|0.23|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent distress tolerance|||||
91756194|NCT00602420|183404799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.037|TWO_SIDED|95.0|0.1|3.24|||t-test, 2 sided|||Tested at the two-sided 0.05 significance level.||3.24|0.10|0.037
91756195|NCT00602420|183404799|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Tested at the two-sided 0.05 significance level.||||0.007
91510826|NCT00600821|182893292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.676||||0.9422|TWO_SIDED|95.0|0.412|1.107|||Cochran-Mantel-Haenszel|||P-value was calculated using 1-sided Cochran-Mantel-Haenszel test stratified by gender and prior adjuvant therapy. Risk ratio in comparison to the Bevacizumab group was calculated assuming all other factors as constant.||1.107|0.412|0.9422
91756196|NCT00649428|183404844|SUPERIORITY_OR_OTHER|||||||1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.00001
91756197|NCT00649428|183404847|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
91756198|NCT02008227|183404880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0003|TWO_SIDED|95.0|0.62|0.87|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.87|0.62|0.0003
91756199|NCT02008227|183404880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||Unstratified Analysis||0.86|0.62|0.0002
91756200|NCT02008227|183404881|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0102|TWO_SIDED|95.0|0.58|0.93|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.58|0.0102
91756201|NCT02008227|183404881|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0052|TWO_SIDED|95.0|0.58|0.91|||Log Rank|||Unstratified Analysis||0.91|0.58|0.0052
91756202|NCT02008227|183404884|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.4928|TWO_SIDED|95.0|0.82|1.1|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.10|0.82|0.4928
91756203|NCT02008227|183404884|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.3596|TWO_SIDED|95.0|0.81|1.08|||Log Rank|||Unstratified Analysis||1.08|0.81|0.3596
91756204|NCT02008227|183404885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3806|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.12|0.74|0.3806
91510827|NCT02066298|182893303|SUPERIORITY|||||||0.14|||||||exact binomial test|a priori threshold for significance was 0.025||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.14
91756205|NCT02008227|183404885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3249|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||Unstratified Analysis||1.10|0.74|0.3249
91756206|NCT02008227|183404888|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.55|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.55|0.18|<0.0001
91756207|NCT02008227|183404888|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.55|||Log Rank|||Unstratified Analysis||0.55|0.21|<0.0001
91756208|NCT02008227|183404889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31||||0.0006|TWO_SIDED|95.0|0.15|0.62|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.62|0.15|0.0006
91756209|NCT02008227|183404889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.38||||0.0003|TWO_SIDED|95.0|0.22|0.65|||Log Rank|||Unstratified Analysis||0.65|0.22|0.0003
91756210|NCT02008227|183404893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0111|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.55|0.0111
91756211|NCT02008227|183404893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.6305|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Cough: Unstratified Analysis||1.33|0.84|0.6305
91756212|NCT02008227|183404893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7406|TWO_SIDED|95.0|0.81|1.16|||Log Rank|||Dyspnea: Unstratified Analysis||1.16|0.81|0.7406
91756213|NCT02008227|183404893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.5221|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||Arm/Shoulder Pain||1.17|0.73|0.5221
91756214|NCT02008227|183404908|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0012|TWO_SIDED|95.0|0.7|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.70|0.0012
91756215|NCT02008227|183404909|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0045|TWO_SIDED|95.0|0.64|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.64|0.0045
91756216|NCT02008227|183404910|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.0012|TWO_SIDED|95.0|0.49|0.84|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.84|0.49|0.0012
91756217|NCT02008227|183404911|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.68|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.68|0.30|<0.0001
91756218|NCT02008227|183404912|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard Ratio|0.96||||0.4981|TWO_SIDED|95.0|0.85|1.08|||Log Rank|||||1.08|0.85|0.4981
91756219|NCT02008227|183404914|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.32|||||TWO_SIDED|95.0|0.21|0.48||||||||0.48|0.21|
91756220|NCT04566601|183404918|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.7||||0.4994|TWO_SIDED|95.0|-1.31|2.69||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||2.69|-1.31|0.4994
91756221|NCT04566601|183404918|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.6||||0.6014|TWO_SIDED|95.0|-2.6|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.51|-2.60|0.6014
91756222|NCT04566601|183404918|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.2||||0.8166|TWO_SIDED|95.0|-2.17|1.72||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.72|-2.17|0.8166
91756223|NCT04566601|183404918|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.4||||0.6588|TWO_SIDED|95.0|-1.96|1.24||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.24|-1.96|0.6588
91756224|NCT04566601|183404918|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.3914|||||||MCP-Mod sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg, and 90% of the maximum effect is achieved at 75 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.3914
91756225|NCT04566601|183404918|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10 and 12) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4104|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4104
91756226|NCT04566601|183404918|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.456|||||||MCP-Mod linear model fit|Model assumption: No parameter assumptions required.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4560
91756227|NCT04566601|183404918|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4908|||||||MCP-Mod exponential model fit|Model assumption: 5% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4908
91759873|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-3.96|11.85||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.85|-3.96|
91510828|NCT02066298|182893303|SUPERIORITY|||||||0.029||||||a priori threshold for significance was 0.025|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.029
91756228|NCT04566601|183404918|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4974|||||||MCP-Mod Emax2 model fit|Model assumption: 70% of the maximum effect is achieved at 5 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4974
91756229|NCT04566601|183404919|OTHER||Odds Ratio (OR)|0.486|||||TWO_SIDED|95.0|0.207|1.14|||||Odds Ratio of BI 1358894 5mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||1.140|0.207|
91756230|NCT04566601|183404919|OTHER||Odds Ratio (OR)|2.294|||||TWO_SIDED|95.0|0.829|7.48|||||Odds Ratio of BI 1358894 25mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||7.480|0.829|
91756231|NCT04566601|183404919|OTHER||Odds Ratio (OR)|1.753|||||TWO_SIDED|95.0|0.698|4.861|||||Odds Ratio of BI 1358894 75mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||4.861|0.698|
91533708|NCT02790606|182944847|SUPERIORITY||||||<|0.0001||||||The p-value is compared to the PG (40%) and computed using the exact binomial test.|Exact binomial test|||"The primary effectiveness endpoint is evaluated against a PG of 40%, which was derived from clinical literature as well as other pivotal and post-market studies of stent grafts at the graft-vein anastomosis of AV access patients dialyzing with an AV graft. 89% estimated power for primary endpoint.~Hypothesis: The proportion of subjects treated with the COVERA™ Vascular Covered Stent (following PTA) with respect to TLPP through 6 months post-index procedure is greater than that of the PG of 40%."||||<0.0001
91533709|NCT02022462|182944930|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change of z-scores.||||.073
91533710|NCT02022462|182944930|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_DEVIATION|0.91||0.066|TWO_SIDED||||||t-test, 2 sided|||Within-group mean z-score change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.066
91756232|NCT04566601|183404919|OTHER||Odds Ratio (OR)|1.352|||||TWO_SIDED|95.0|0.642|2.913|||||Odds Ratio of BI 1358894 125mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||2.913|0.642|
91756233|NCT04566601|183404920|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.1||||0.9675|TWO_SIDED|95.0|-5.11|4.9||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.90|-5.11|0.9675
91533711|NCT02022462|182944931|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.983|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.983
91533712|NCT02022462|182944931|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|1.95||0.533|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.533
91533713|NCT02022462|182944932|SUPERIORITY|||||||0.731|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.731
91533714|NCT02022462|182944932|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.211
91533715|NCT02022462|182944933|SUPERIORITY||Mean Difference (Net)|0.04||||0.244|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.244
91533716|NCT02022462|182944933|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_DEVIATION|0.35||0.016|TWO_SIDED||||||t-test, 2 sided|||||||.016
91533717|NCT02022462|182944934|SUPERIORITY||Mean Difference (Net)|0.4||||0.019|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.019
91533718|NCT02022462|182944934|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.66||0.609|TWO_SIDED||||||t-test, 2 sided|||||||.609
91533719|NCT02022462|182944935|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.203
91533720|NCT02022462|182944935|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.59||0.48|TWO_SIDED||||||t-test, 2 sided|||||||.480
91533721|NCT02022462|182944936|SUPERIORITY||Mean Difference (Net)|0.01||||0.897|TWO_SIDED||||||t-test, 2 sided|||||||.897
91533722|NCT02022462|182944936|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.48||0.903|TWO_SIDED||||||t-test, 2 sided|||||||.903
91756234|NCT04566601|183404920|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.01||||0.9969|TWO_SIDED|95.0|-5.08|5.1||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.10|-5.08|0.9969
91756235|NCT04566601|183404920|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.79||||0.7542|TWO_SIDED|95.0|-5.73|4.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.15|-5.73|0.7542
91756236|NCT04566601|183404920|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.17||||0.5683|TWO_SIDED|95.0|-2.86|5.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.19|-2.86|0.5683
91756237|NCT04566601|183404921|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-2.07||||0.3568|TWO_SIDED|95.0|-6.49|2.35||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.35|-6.49|0.3568
91756238|NCT04566601|183404921|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.21||||0.6009|TWO_SIDED|95.0|-3.33|5.75||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.75|-3.33|0.6009
91756239|NCT04566601|183404921|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.36||||0.8705|TWO_SIDED|95.0|-4.7|3.98||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||3.98|-4.70|0.8705
91756240|NCT04566601|183404921|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.15||||0.5262|TWO_SIDED|95.0|-2.41|4.71||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.71|-2.41|0.5262
91756241|NCT04566601|183404922|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-1.83||||0.0782|TWO_SIDED|95.0|-3.87|0.21||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.21|-3.87|0.0782
91756242|NCT04566601|183404922|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.23||||0.8266|TWO_SIDED|95.0|-1.86|2.32||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.32|-1.86|0.8266
91533723|NCT02022462|182944937|SUPERIORITY||Mean Difference (Net)|-0.787||||0.433|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.433
91756243|NCT04566601|183404922|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.27||||0.791|TWO_SIDED|95.0|-2.28|1.74||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.74|-2.28|0.7910
91756244|NCT04566601|183404922|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.8743|TWO_SIDED|95.0|-1.77|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.51|-1.77|0.8743
91756245|NCT04566601|183404923|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.05||||0.8016|TWO_SIDED|95.0|-0.47|0.37||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.37|-0.47|0.8016
91756246|NCT04566601|183404923|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.23||||0.2929|TWO_SIDED|95.0|-0.67|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.67|0.2929
91756247|NCT04566601|183404923|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.01||||0.9666|TWO_SIDED|95.0|-0.42|0.4||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.40|-0.42|0.9666
91756248|NCT04566601|183404923|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.18||||0.2833|TWO_SIDED|95.0|-0.52|0.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.15|-0.52|0.2833
91756249|NCT04566601|183404924|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4552|TWO_SIDED|95.0|-0.45|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.45|0.4552
91756250|NCT04566601|183404924|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4734|TWO_SIDED|95.0|-0.47|0.22||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.22|-0.47|0.4734
91756251|NCT04566601|183404924|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.03||||0.8388|TWO_SIDED|95.0|-0.36|0.29||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.29|-0.36|0.8388
91759874|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.17|||||TWO_SIDED|95.0|-4.8|11.13||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.13|-4.80|
91533724|NCT02022462|182944937|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.52||0.936|TWO_SIDED||||||t-test, 2 sided|||||||.936
91756252|NCT04566601|183404924|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.08||||0.554|TWO_SIDED|95.0|-0.35|0.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.19|-0.35|0.5540
91756253|NCT00757822|183404925|SUPERIORITY_OR_OTHER||Difference in Percentages|4.6|||>|0.76|TWO_SIDED|90.0|-9.5|18.6|||Fisher Exact|||The incidence of PON per arm will be determined and expressed as a percentage of the total patients per arm. Treatment efficacy will be measured as the percentage-point decrease in PON in the treatment arm (Marinol) compared to the standard therapy arm (ondansetron). Null hypothesis: Marinol treatment is not superior to ondansetron treatment. We will test the statistical significance with Fisher's Exact test at a significance level of 0.05||18.6|-9.5|>0.76
91756254|NCT00757822|183404926|SUPERIORITY_OR_OTHER||||||>|0.92|||||||Fisher Exact|One-sided Fisher's Exact test was performed comparing the percentage of subjects with at least one VAS score \> 0. (Marinol\>Ondansetron).||||||>0.92
91756255|NCT00757822|183404927|SUPERIORITY_OR_OTHER||Difference in Percentages|7.7|||>|0.55|TWO_SIDED|90.0|-12.1|13.3|||Fisher Exact|||||13.3|-12.1|>0.55
91756256|NCT00757822|183404928|SUPERIORITY_OR_OTHER||||||=|0.981|TWO_SIDED||||||Wilcoxon Rank-Sum test|||||||=0.981
91756257|NCT00757822|183404929|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Fisher Exact|||||||>0.90
91756258|NCT00757822|183404930|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Fisher Exact|||||||>0.37
91756259|NCT00757822|183404931|SUPERIORITY_OR_OTHER||||||>|0.75|TWO_SIDED||||||FREQ Procedure|||Comparisons at 24-48 hr post-surgery. Null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction.||||>0.75
91756260|NCT00757822|183404931|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||FREQ procedure|||Comparisons of both arms at 2-6 weeks; null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction||||>0.10
91510829|NCT02066298|182893303|SUPERIORITY|||||||0.001||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations.||||0.001
91510830|NCT02066298|182893303|SUPERIORITY|||||||0.45||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations.||||0.45
91513549|NCT03029208|182898970|SUPERIORITY||LS mean difference|-0.73||||0.7141|TWO_SIDED|95.0|-3.26|1.81|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.81|-3.26|0.7141
91756261|NCT00757822|183404932|SUPERIORITY_OR_OTHER||||||>|0.29|TWO_SIDED||||||FREQ procedure|||Comparison of both group responses at 24-48 hours.||||>0.29
91756262|NCT00757822|183404932|SUPERIORITY_OR_OTHER||||||>|0.55|TWO_SIDED||||||FREQ Procedure|||Comparisons of both arms at 2-6 weeks.||||>0.55
91756263|NCT02702180|183404941|SUPERIORITY||Least Square Means (LSmean)|-4.6||||0.1688|TWO_SIDED|95.0|-11.1|2.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|Primary endpoint was evaluated using analysis of covariance with treatment, whole lung lavage within 2 months before baseline, and geographic region as factors, and baseline values as covariates. To control type I error, key secondary endpoints were analyzed using a testing hierarchy wherein once daily molgramostim and placebo was compared and if statistical significance was reached, evaluation of intermittent molgramostim and placebo would proceed.||2.0|-11.1|0.1688
91756264|NCT02702180|183404941|SUPERIORITY||Least Square Means (LSmean)|-2.8||||0.3968|TWO_SIDED|95.0|-9.3|3.7|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||3.7|-9.3|0.3968
91756265|NCT02702180|183404942|SUPERIORITY||Least Square Means (LSmean)|20.6||||0.3159|TWO_SIDED|95.0|-19.8|61.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||61.0|-19.8|0.3159
91756266|NCT02702180|183404942|SUPERIORITY||Least Square Means (LSmean)|5.6||||0.7809|TWO_SIDED|95.0|-34.1|45.2|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||45.2|-34.1|0.7809
91756267|NCT02702180|183404943|SUPERIORITY||Least Square Means (LSmean)|-7.6||||0.0103|TWO_SIDED|95.0|-13.4|-1.8|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||-1.8|-13.4|0.0103
91756268|NCT02702180|183404943|SUPERIORITY||Least Square Means (LSmean)|-7.0||||0.0173|TWO_SIDED|95.0|-12.7|-1.3|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24..|||-1.3|-12.7|0.0173
91756269|NCT02702180|183404944|SUPERIORITY||Risk Ratio (RR)|0.284||||0.1918|TWO_SIDED|95.0|0.043|1.881|||Negative binomial regression||The estimated value represents the RR between once daily molgramostim and placebo groups.|||1.881|0.043|0.1918
91756270|NCT02702180|183404944|SUPERIORITY||Risk Ratio (RR)|0.367||||0.2421|TWO_SIDED|95.0|0.068|1.968|||Negative binomial regression||The estimated value represents the RR between intermittent molgramostim and placebo groups.|||1.968|0.068|0.2421
91756271|NCT01463072|183405007|OTHER||Percent|35.0|||||TWO_SIDED|95.0|21.0|52.0|||||35% of participants were responders (CR+PR).|||52|21|
91756272|NCT01463072|183405009|SUPERIORITY||Odds Ratio (OR)|5.8||||0.01|TWO_SIDED|95.0|1.3|33.1|||Fisher Exact||Ratio is intermediate/high toxicity risk over low toxicity risk|CARG chemotherapy toxicity risk predictive of chemotherapy toxicity (grade 3)||33.1|1.3|0.01
91756273|NCT01463072|183405009|SUPERIORITY||Ratio of group means|1.38||||0.02|TWO_SIDED|95.0|1.04|1.8|||t-test, 2 sided||Ratio is dose reduction over no dose reduction.|CARG chemotherapy toxicity risk predictive of dose reduction due to chemotherapy toxicity||1.80|1.04|0.02
91756274|NCT00548717|183405040|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 1.||||0.77
91533725|NCT02022462|182944938|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change in z-scores of diet.||||.228
91533726|NCT02022462|182944938|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.03||0.617|TWO_SIDED||||||t-test, 2 sided|||||||.617
91533727|NCT02022462|182944939|SUPERIORITY||Mean Difference (Net)|0.01||||0.894|TWO_SIDED||||||t-test, 2 sided|||||||.894
91533728|NCT02022462|182944939|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.46||0.93|TWO_SIDED||||||t-test, 2 sided|||||||.930
91533729|NCT02022462|182944940|SUPERIORITY||Mean Difference (Net)|0.15||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||.530
91533730|NCT02022462|182944940|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_DEVIATION|1.27||0.458|TWO_SIDED||||||t-test, 2 sided|||||||.458
91533731|NCT02022462|182944941|SUPERIORITY||Mean Difference (Net)|0.31||||0.036|TWO_SIDED||||||t-test, 2 sided|||||||.036
91533732|NCT02022462|182944941|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|1.0||0.892|TWO_SIDED||||||t-test, 2 sided|||||||.892
91533733|NCT02022462|182944942|SUPERIORITY||Mean Difference (Net)|0.41||||0.931|TWO_SIDED||||||t-test, 2 sided|||||||.931
91533734|NCT02022462|182944942|SUPERIORITY||Mean Difference (Net)|-6.43|STANDARD_DEVIATION|24.34||0.058|TWO_SIDED||||||t-test, 2 sided|||||||.058
91533735|NCT02022462|182944943|SUPERIORITY||Mean Difference (Net)|0.4||||0.576|TWO_SIDED||||||t-test, 2 sided|||||||.576
91533736|NCT02022462|182944943|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_DEVIATION|33.89||0.829|TWO_SIDED||||||t-test, 2 sided|||||||.829
91533737|NCT02022462|182944944|SUPERIORITY|||||||0.792|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.792
91756275|NCT00548717|183405040|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 2.||||0.59
91756276|NCT00548717|183405040|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 3.||||0.92
91756277|NCT00548717|183405040|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 8.||||0.63
91533738|NCT02022462|182944944|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_DEVIATION|0.55||0.622|TWO_SIDED||||||t-test, 2 sided|||||||.622
91533739|NCT02022462|182944945|SUPERIORITY||Mean Difference (Net)|1.986||||0.049|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.049
91533740|NCT02022462|182944945|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||||||.211
91533741|NCT03613129|182944946|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.011|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.011
91533742|NCT03613129|182944946|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.136|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.136
91756278|NCT00548717|183405040|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 12.||||0.79
91533743|NCT03613129|182944946|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.009
91533744|NCT03613129|182944946|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.451|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.451
91533745|NCT03613129|182944946|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.240
91533746|NCT03613129|182944947|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.039|||||||t-test, 2 sided|||||||0.039
91533747|NCT03613129|182944947|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.191|||||||t-test, 2 sided|||||||0.191
91533748|NCT03613129|182944947|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.016|||||||t-test, 2 sided|||||||0.016
91533749|NCT03613129|182944947|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.053|||||||t-test, 2 sided|||||||0.053
91533750|NCT03613129|182944947|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.06|||||||t-test, 2 sided|||||||0.060
91533751|NCT03613129|182944948|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.587|||||||t-test, 2 sided|||||||0.587
91533752|NCT03613129|182944948|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.618|||||||t-test, 2 sided|||||||0.618
91533753|NCT03613129|182944948|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.634|||||||t-test, 2 sided|||||||0.634
91533754|NCT03613129|182944948|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.355|||||||t-test, 2 sided|||||||0.355
91533755|NCT03613129|182944948|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.417|||||||t-test, 2 sided|||||||0.417
91533756|NCT02334306|182944949|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.3||0.262|TWO_SIDED|90.0|-3.6|0.7|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||0.7|-3.6|0.262
91756279|NCT04971941|183405127|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.17||0.001|TWO_SIDED|95.0|0.4|2.1||This P value applies to comparison of IAN with and without DentalVibe|t-test, 2 sided|df =58||Sample size estimation from Nanitsos 2010: Using the P value from the paired T test with 61 degrees of freedom the T statistic calculated at 4.365. From mean difference 9.3 SD was calculated as 16.66 for an effect size of 0.558. This generated a sample size of 44 subjects, receiving 2 injections (1 with DV3 and 1 without), is necessary to attain 95% power for a paired t-test comparing the 2 pain measures at a two-tailed alpha level of 0.05. P value for IAN||2.1|0.4|0.001
91756280|NCT04971941|183405127|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|1.75||0.02|TWO_SIDED|95.0|-1.7|-1.5|||t-test, 2 sided|df= 58||||-1.5|-1.7|0.02
91756281|NCT04971941|183405127|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.74||0.004|TWO_SIDED|95.0|0.4|2.1|||t-test, 2 sided|||||2.1|0.4|0.004
91510831|NCT03160703|182893363|SUPERIORITY||Mean Difference (Net)|-0.02||||0.2681|TWO_SIDED|95.0|-0.05|0.01||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.01|-0.05|0.2681
91756282|NCT04971941|183405128|SUPERIORITY||Mean Difference (Net)|4.0||||0.001|TWO_SIDED|14.0|0.4|4.8||This P value applies to comparing IAN with or with DV as measured by SSI tolerability/ability to endure|t-test, 2 sided|||||4.8|0.4|0.001
91756283|NCT04971941|183405128|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91756284|NCT04971941|183405128|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91756285|NCT04971941|183405128|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
91756286|NCT04971941|183405128|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
91756287|NCT04971941|183405128|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||||||0.044
91756288|NCT04971941|183405128|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
91756289|NCT04971941|183405128|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
91756290|NCT04971941|183405128|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||0.053
91756291|NCT04971941|183405129|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||The null hypothesis is that there is no relation between use of DV and numb times. There were no studies from which to perform a power calculation for this outcome measure||||0.459
91756292|NCT00079677|183405130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0003||95.0|1.67|5.46||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05||5.46|1.67|0.0003
91756293|NCT00079677|183405131|SUPERIORITY_OR_OTHER|||||||0.0069||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|Cochran-Mantel-Haenszel|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0069
91756294|NCT01985360|183405133|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.29||||||||1.29|0.79|
91756295|NCT04598269|183405134|SUPERIORITY||Least Square Means (LSM) % Differences|-33.01|STANDARD_ERROR_OF_MEAN|8.971|<|0.001|TWO_SIDED|90.0|-47.95|-18.08||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Model Repeated Measures (MMRM)||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Week 4: Least Square Means (LSM) % differences ATI-1777 arm minus vehicle arm"|||-18.08|-47.95|<0.001
91756296|NCT04598269|183405135|SUPERIORITY||LSM % Differences|-23.53|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.47|-8.59||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|MMRM||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 8: LSM % differences ATI-1777 arm minus vehicle arm"|Day 8 statistical analysis||-8.59|-38.47|0.005
91510832|NCT03160703|182893363|SUPERIORITY||Mean Difference (Net)|-0.05||||0.0043|TWO_SIDED|95.0|-0.08|-0.02||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.02|-0.08|0.0043
91510833|NCT03160703|182893363|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.05||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.05|-0.12|<.0001
91756297|NCT04598269|183405135|SUPERIORITY||LSM % Differences|-23.44|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.38|-8.5||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Models Analysis||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 15: LSM % differences ATI-1777 arm minus vehicle arm"|Day 15 statistical analysis||-8.50|-38.38|0.005
91756298|NCT04598269|183405136|SUPERIORITY||Odds Ratio, log|15.7|||<|0.001|TWO_SIDED|90.0|3.9|63.2||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|Regression, Logistic||Active/Vehicle|||63.2|3.9|<0.001
91756299|NCT04598269|183405137|SUPERIORITY||Odds Ratio, log|5.9||||0.003|TWO_SIDED|90.0|2.1|17.0||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Linear||Active/Vehicle|||17.0|2.1|0.003
91756300|NCT04598269|183405138|SUPERIORITY||Odds Ratio, log|1.7||||0.203|TWO_SIDED|90.0|0.6|5.3||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Logistic||Active/Vehicle|||5.3|0.6|0.203
91756301|NCT04598269|183405139|SUPERIORITY|||||||0.148||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.148
91756302|NCT04598269|183405139|SUPERIORITY|||||||0.017||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.017
91756303|NCT04598269|183405139|SUPERIORITY|||||||0.002||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.002
91756304|NCT04598269|183405140|SUPERIORITY|||||||0.088||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.088
91756305|NCT04598269|183405140|SUPERIORITY|||||||0.022||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.022
91756306|NCT04598269|183405140|SUPERIORITY||||||<|0.001||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|MMRM|||Week 4 statistical analysis||||<0.001
91756307|NCT04598269|183405141|SUPERIORITY|||||||0.014||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.014
91756308|NCT04598269|183405141|SUPERIORITY|||||||0.069||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.069
91510834|NCT03160703|182893363|SUPERIORITY||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.08||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.08|-0.15|<.0001
91756309|NCT04598269|183405141|SUPERIORITY|||||||0.06||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.060
91756310|NCT00424190|183405142|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.2|6.2|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||6.2|-4.2|
91756311|NCT02963701|183405176|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|99.16|STANDARD_DEVIATION|8.49|||TWO_SIDED|90.0|96.52|101.89|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.89|96.52|
91756312|NCT02963701|183405177|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|89.16|STANDARD_DEVIATION|19.28|||TWO_SIDED|90.0|83.88|94.76|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||94.76|83.88|
91756313|NCT02963701|183405178|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.75|STANDARD_DEVIATION|12.96|||TWO_SIDED|90.0|95.73|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation \[%\].|||103.95|95.73|
91756314|NCT02963701|183405179|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|102.16|STANDARD_DEVIATION|15.37|||TWO_SIDED|90.0|97.3|107.27|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type \[SD\] was actually the intra-individual geometric coefficient of variation \[%\].|||107.27|97.30|
91756315|NCT02963701|183405180|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|98.97|STANDARD_DEVIATION|8.13|||TWO_SIDED|90.0|96.44|101.57|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%)of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.57|96.44|
91756316|NCT02963701|183405181|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.67|STANDARD_DEVIATION|13.5|||TWO_SIDED|90.0|95.48|104.04|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.04|95.48|
91756317|NCT02963701|183405182|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|95.96|STANDARD_DEVIATION|14.27|||TWO_SIDED|90.0|91.7|100.4|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.40|91.70|
91756318|NCT02963701|183405183|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|96.12|STANDARD_DEVIATION|14.06|||TWO_SIDED|90.0|91.92|100.51|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.51|91.92|
91756319|NCT02963701|183405184|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|90.83|STANDARD_DEVIATION|21.49|||TWO_SIDED|90.0|84.87|97.21|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||97.21|84.87|
91510835|NCT03160703|182893363|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.0779|TWO_SIDED|95.0|0.0|0.06||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.06|-0.00|0.0779
91756320|NCT02963701|183405185|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.86|STANDARD_DEVIATION|7.89|||TWO_SIDED|90.0|99.33|104.46|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.46|99.33|
91756321|NCT02963701|183405186|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.65|STANDARD_DEVIATION|7.01|||TWO_SIDED|90.0|99.4|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||103.95|99.40|
91756322|NCT02963701|183405187|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|86.53|STANDARD_DEVIATION|16.85|||TWO_SIDED|90.0|82.03|91.28|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||91.28|82.03|
91756323|NCT02963701|183405188|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|Ratio (%)|106.17|STANDARD_DEVIATION|14.77|||TWO_SIDED|90.0|101.3|111.26|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||111.26|101.30|
91756324|NCT01345682|183405189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.792||||0.0257|TWO_SIDED|95.0|0.643|0.977||Log-rank test stratified by baseline Eastern Cooperative Oncology Group (ECOG) Performance score (PS)(0 or 1) and prior use of Epidermal Growth Factor Receptor (EGFR)-targeted antibody in the Recurrent and/or Metastatic (R/M) setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.977|0.643|0.0257
91756325|NCT01345682|183405190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.6755|TWO_SIDED|95.0|0.786|1.169||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||1.169|0.786|0.6755
91756326|NCT01345682|183405191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.101|TWO_SIDED|95.0|0.88|4.14|||Regression, Logistic||"Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||4.14|0.88|0.1010
91756327|NCT01345682|183405192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0353|TWO_SIDED|95.0|1.03|2.26|||Regression, Logistic||"Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||2.26|1.03|0.0353
91510836|NCT03160703|182893363|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0001|TWO_SIDED|95.0|0.03|0.1||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.10|0.03|0.0001
91510837|NCT00047463|182893421|SUPERIORITY_OR_OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the groups would be similar in tolerance. This was a pilot study so we did not do a power calculation.||||0.26
91510838|NCT03235024|182893463|EQUIVALENCE|A sample size of 52 per group would achieve \>80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.||||||0.0228||||||At Week 2|t-test, 1 sided|||||||0.0228
91510839|NCT02357576|182893470|OTHER|Percentage and frequencies were used to describe the incidence of PNAC in the two groups.||||||0.617|||||||Fisher Exact|||||||0.617
91756328|NCT01345682|183405194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.01||0.03|TWO_SIDED|95.0|-8.31|-0.42||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score (PS) and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||-0.42|-8.31|0.0300
91759875|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-9.86|5.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.81|-9.86|
91756329|NCT01345682|183405195|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.16||0.9773|TWO_SIDED|95.0|-4.3|4.18||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.18|-4.30|0.9773
91510840|NCT02357576|182893471|OTHER|Percentage and frequencies were used to describe the incidence of severe PNAC.||||||0.45|||||||Fisher Exact|||||||0.450
91510841|NCT02357576|182893472|OTHER|The Kaplan Meier curve was used to evaluated the time to first PNAC event.||||||0.2716|||||||Log Rank|A log rank test was used to test the equality of the survival curve between the two groups.||||||0.2716
91510842|NCT00261716|182893489|SUPERIORITY_OR_OTHER|||||||0.33|||||||Chi-squared|1 degree of freedom||Intent to treat analysis||||.33
91510843|NCT00261716|182893490|SUPERIORITY_OR_OTHER|||||||0.75|||||||t-test, 2 sided|degrees of freedom=36||intent to treat analysis||||.75
91510844|NCT00261716|182893491|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|degrees of freedom=17||||||.41
91510845|NCT00261716|182893492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|Fishers exact= 1.0; one degree of freedom||intent to treat --all participants who obtained at least one job||||>.05
91510846|NCT00261716|182893492|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>.05
91510847|NCT00261716|182893493|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|employment status effect- F(1,12)=..85||Intent to treat analysis||||.37
91510848|NCT00261716|182893493|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|time effect F(1,54)=.2.05||||||.16
91510849|NCT00261716|182893493|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|employment status X time effect F (1,54)=.. 24||||||.63
91510850|NCT00261716|182893494|SUPERIORITY_OR_OTHER|||||||0.62|||||||Mixed Models Analysis|employment status effect F(1,12)=.26||intent to treat analysis||||.62
91510851|NCT00261716|182893494|SUPERIORITY_OR_OTHER|||||||0.65|||||||Mixed Models Analysis|time effect F (1,58)=.21 ,.||||||.65
91510852|NCT00261716|182893494|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mixed Models Analysis|employment status X time effect F(1,58)=.06||||||.81
91533757|NCT02334306|182944950|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.33||0.82|TWO_SIDED|90.0|0.52|1.64|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For plasma cell levels||1.64|0.52|0.820
91510853|NCT00261716|182893495|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mixed Models Analysis|employment status effect F(1,12)=1.95,||Intent to treat analysis||||.19
91510854|NCT00261716|182893495|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|time effect (1.54)=2.99,||||||.09
91510855|NCT00261716|182893495|SUPERIORITY_OR_OTHER|||||||0.39|||||||Mixed Models Analysis|employment status X time effect (F(1,54)=.74||||||.39
91510856|NCT00128180|182893496|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
91510857|NCT02047110|182893506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2652|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||26.6|-12.1|0.2652
91510858|NCT02047110|182893506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4129|TWO_SIDED|90.0|-15.9|20.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||20.8|-15.9|0.4129
91510859|NCT02047110|182893506|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4243|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||17.0|-21.8|0.4243
91510860|NCT02047110|182893507|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.0229|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||-0.1|-0.7|0.0229
91510861|NCT02047110|182893507|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.3||||0.1038|TWO_SIDED|90.0|-0.6|0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||0.1|-0.6|0.1038
91756330|NCT01345682|183405196|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7767|TWO_SIDED|95.0|-3.28|4.39||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.39|-3.28|0.7767
91756331|NCT01345682|183405197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.494|TWO_SIDED|95.0|0.717|1.99|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.990|0.717|0.494
91756332|NCT01345682|183405198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.584|TWO_SIDED|95.0|0.687|1.95|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.950|0.687|0.584
91756333|NCT01345682|183405199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.816|TWO_SIDED|95.0|0.657|1.705|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.705|0.657|0.816
91756334|NCT01345682|183405200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0217|TWO_SIDED|95.0|0.55|0.96||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|||0.96|0.55|0.0217
91510862|NCT02047110|182893507|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.5||||0.0101|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||-0.1|-0.7|0.0101
91510863|NCT02047110|182893508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0||||0.0238|TWO_SIDED|90.0|-4.6|33.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||33.8|-4.6|0.0238
91510864|NCT02047110|182893508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.1||||0.012|TWO_SIDED|90.0|-0.8|35.3||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||35.3|-0.8|0.0120
91510865|NCT02047110|182893508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.0465|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.0465
91510866|NCT02047110|182893509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|90.0|-19.4|19.4|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||19.4|-19.4|
91510867|NCT02047110|182893509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-18.3|18.3|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||18.3|-18.3|
91510868|NCT02047110|182893509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|90.0|-12.1|26.6|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||26.6|-12.1|
91510869|NCT02047110|182893510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0||||0.0092|TWO_SIDED|90.0|5.5|43.1||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||43.1|5.5|0.0092
91510870|NCT02047110|182893510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.3||||0.1243|TWO_SIDED|90.0|-5.9|30.5||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||30.5|-5.9|0.1243
91510871|NCT02047110|182893510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.1198|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.1198
91533758|NCT02334306|182944950|SUPERIORITY||Median Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.4||0.291|TWO_SIDED|90.0|0.33|1.28|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For TFH cells||1.28|0.33|0.291
91533759|NCT02334306|182944951|SUPERIORITY||Mean Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.17||0.44|TWO_SIDED|90.0|0.65|1.18|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For total plasma cells||1.18|0.65|0.440
91533760|NCT02334306|182944951|SUPERIORITY||Median Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.28||0.008|TWO_SIDED|90.0|0.26|0.7|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For CD4/ICOS TFH cells||0.70|0.26|0.008
91533761|NCT02334306|182944951|SUPERIORITY||Median Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|90.0|0.64|1.59|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For PD-1/ICOS TFH cells||1.59|0.64|0.972
91533762|NCT02334306|182944953|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.7||0.574|TWO_SIDED|90.0|-0.8|1.6|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||1.6|-0.8|0.574
91533763|NCT02334306|182944954|SUPERIORITY||Difference in percentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI \[3\]||50.9|-3.1|0.252
91533764|NCT02334306|182944954|SUPERIORITY||Difference in precentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI\[4\]||50.9|-3.1|0.252
91533765|NCT02390557|182944963|SUPERIORITY||Mean Difference (Final Values)|10.7||||0.074|TWO_SIDED||||||Chi-squared, Corrected|||we had a prior hypothesis that the survey intervention would be associated with a larger increase in perceived quality of health care compared with control from Wave 1 to Wave 2||||0.074
91533766|NCT02390557|182944963|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.069|TWO_SIDED||||||Chi-squared, Corrected|||We compared change in perception of quality of health care between Control v YES Health, wave 1 v Wave 2||||.069
91533767|NCT02002819|182944965|SUPERIORITY||Mean Difference (Net)|0.07||||0.55|TWO_SIDED|95.0|-0.18|0.32|||ANOVA|||||0.32|-0.18|0.55
91533768|NCT02002819|182944966|SUPERIORITY||Mean Difference (Net)|2.9||||0.14|TWO_SIDED|95.0|-1.0|6.8|||ANOVA|||||6.8|-1.0|0.14
91533769|NCT02002819|182944967|SUPERIORITY||Mean Difference (Net)|-1.0||||0.43|TWO_SIDED|95.0|-3.4|1.5|||ANOVA|||||1.5|-3.4|.43
91533770|NCT02002819|182944968|SUPERIORITY||Mean Difference (Net)|0.1||||0.63|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||||0.4|-0.2|0.63
91533771|NCT02002819|182944969|SUPERIORITY||Mean Difference (Net)|0.1||||0.9|TWO_SIDED|95.0|-1.1|1.3|||ANOVA|||||1.3|-1.1|0.90
91533772|NCT02002819|182944970|SUPERIORITY||Mean Difference (Net)|0.0||||0.8|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|||||0.3|-0.3|0.80
91756335|NCT01345682|183405201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.004|TWO_SIDED|95.0|0.5|0.89||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.89|0.50|0.0040
91756336|NCT01345682|183405202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0268|TWO_SIDED|95.0|0.56|0.97||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.97|0.56|0.0268
91756337|NCT03101085|183405225|OTHER|We performed a paired T-test analysis to ascertain whether the COX/CS activity while on S-equol was comparable or different than the COX/CS while on placebo. For each participant, the COX/CS value while on S-equol was subtracted from their COX/CS value while on placebo.|||||>|0.05|||||||Paired T-test|||As the order of the intervention does not matter, all 39 participants who contributed data to the final analysis are included together.||||>0.05
91533773|NCT02002819|182944971|SUPERIORITY||Mean Difference (Net)|-1.0||||0.46|TWO_SIDED|95.0|-3.6|1.7|||ANOVA|||||1.7|-3.6|0.46
91533774|NCT02002819|182944972|SUPERIORITY||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.9|1.1|||ANOVA|||||1.1|-0.9|0.40
91533775|NCT02002819|182944973|SUPERIORITY||Mean Difference (Net)|7.4||||0.046|TWO_SIDED|95.0|0.2|14.7|||ANOVA|||||14.7|0.2|0.046
91533776|NCT02002819|182944974|SUPERIORITY||Mean Difference (Net)|-2.5||||0.3|TWO_SIDED|95.0|-7.8|2.7|||ANOVA|||||2.7|-7.8|.30
91533777|NCT02002819|182944975|SUPERIORITY||Mean Difference (Net)|3.8||||0.52|TWO_SIDED|95.0|-8.5|16.0|||Cohen f|||||16.0|-8.5|0.52
91533778|NCT02002819|182944976|SUPERIORITY||Mean Difference (Net)|0.7||||0.4|TWO_SIDED|95.0|-1.0|2.4|||ANOVA|||||2.4|-1.0|0.40
91533779|NCT02002819|182944977|SUPERIORITY||Mean Difference (Net)|-0.2||||0.63|TWO_SIDED|95.0|-1.1|0.7|||ANOVA|||||0.7|-1.1|0.63
91533780|NCT02002819|182944979|SUPERIORITY||Mean Difference (Net)|0.8||||0.15|TWO_SIDED|95.0|-0.3|1.8|||ANOVA|||||1.8|-0.3|.15
91533781|NCT00920686|182944983|SUPERIORITY_OR_OTHER|||||||0.6407|||||||Log Rank|||||||0.6407
91756338|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.95|||||TWO_SIDED|95.0|21.76|41.25|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||41.25|21.76|
91510872|NCT02047110|182893511|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.1241|TWO_SIDED|90.0|-1.0|0.2||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||0.2|-1.0|0.1241
91510873|NCT02047110|182893511|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|0.3||||0.3033|TWO_SIDED|90.0|-0.5|1.0||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||1.0|-0.5|0.3033
91533782|NCT03006341|182944992|OTHER||C-Statistic|0.81|||||||||||Regression, Logistic|Logistic regression with bleeding history or predisposition as dependent and treatment groups and claims based variables as the independent variables|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
91533783|NCT03006341|182944994|OTHER||Adjusted R squared statistic|0.02|||||||||||Regression, Linear|Logistic regression model with serum creatinine as the dependent variable and treatment groups and claims based variables as the independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
91533784|NCT03006341|182944996|OTHER||Adjusted R squared statistic|0.04|||||||||||Regression, Linear|Linear regression model with duration of atrial fibrillation as dependent and treatment groups and claims based variables as independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
91533785|NCT03006341|182945002|OTHER||C-Statistic|0.88|||||||||||Regression, Logistic|Logistic regression model with diabetes as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
91533786|NCT03006341|182945003|OTHER||C-Statistic|0.69|||||||||||Regression, Logistic|Logistic regression model with hyperlipidemia as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
91533787|NCT03006341|182945004|OTHER||Adjusted R squared statistic|0.34|||||||||||Regression, Linear|Linear regression model with HAS-BLED score as the dependent variable and treatment groups and claims based variables as the independent variables.|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
91533788|NCT00335153|182945046|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533789|NCT00335153|182945047|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
91533790|NCT00335153|182945048|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533791|NCT00335153|182945049|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533792|NCT00335153|182945050|SUPERIORITY_OR_OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
91533793|NCT00335153|182945051|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533794|NCT00335153|182945052|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533795|NCT00335153|182945053|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533796|NCT00335153|182945054|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533797|NCT00335153|182945055|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91756339|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.86|||||TWO_SIDED|95.0|21.66|41.17|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||41.17|21.66|
91756340|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.91|||||TWO_SIDED|95.0|21.89|41.12|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||41.12|21.89|
91756341|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Difference in percentages|0.09|||||TWO_SIDED|95.0|-3.15|3.36|||Miettinen & Nurminen score method|||Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||3.36|-3.15|
91510874|NCT02047110|182893511|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.2||||0.3203|TWO_SIDED|90.0|-0.8|0.4||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||0.4|-0.8|0.3203
91510875|NCT02047110|182893512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2639|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||26.6|-12.1|0.2639
91533798|NCT00335153|182945056|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533799|NCT00335153|182945057|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533800|NCT00335153|182945058|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533801|NCT00335153|182945059|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533802|NCT00335153|182945060|SUPERIORITY_OR_OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
91533803|NCT00335153|182945061|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533804|NCT00335153|182945062|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91510876|NCT02047110|182893512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.1||||0.2691|TWO_SIDED|90.0|-10.9|25.7||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||25.7|-10.9|0.2691
91510877|NCT02047110|182893512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4174|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||17.0|-21.8|0.4174
91510878|NCT03296163|182893521|EQUIVALENCE|"Equivalence analysis was based on the risk ratio (RR) (MB02/EU-approved Avastin) with an equivalence margin predefined \[0.73, 1.36\].~The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the RR and corresponding 2-sided 90% confidence interval (CI)."|Risk Ratio (RR)|0.91|||||TWO_SIDED|90.0|0.78|1.06|||||Direction of comparison is: For RR: MB02/EU-approved Avastin. 95% CI was also calculated: (0.758, 1.092)|||1.060|0.780|
91510879|NCT03296163|182893521|EQUIVALENCE|The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the risk difference (RD) (MB02-EU-approved Avastin) with an equivalence margin predefined \[-12%, 12%\] and corresponding 2-sided 95% CI.|Risk Difference (RD)|-4.02|||||TWO_SIDED|90.0|-10.51|2.47|||||Direction of comparison is: For RD: MB02 - EU-approved Avastin. 95% CI was also calculated: (-11.76, 3.71)|||2.47|-10.51|
91533805|NCT00335153|182945063|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533806|NCT00335153|182945064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533807|NCT00335153|182945065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91533808|NCT00335153|182945066|SUPERIORITY_OR_OTHER|||||||0.824|||||||t-test, 2 sided|||||||0.824
91533809|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0464|TWO_SIDED|95.0|-0.98|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.98|0.0464
91533810|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.17|-1.13|0.0080
91533811|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.0159|TWO_SIDED|95.0|-1.08|-0.11|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.11|-1.08|0.0159
91533812|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.29||0.2563|TWO_SIDED|95.0|-0.89|0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.24|-0.89|0.2563
91756342|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.5|||||TWO_SIDED|95.0|28.54|48.9|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||48.90|28.54|
91756343|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|39.08|||||TWO_SIDED|95.0|29.16|49.46|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||49.46|29.16|
91756344|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.79|||||TWO_SIDED|95.0|29.03|49.06|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||49.06|29.03|
91756345|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|-0.59|||||TWO_SIDED|95.0|-4.12|2.92|||Miettinen & Nurminen score method|||Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||2.92|-4.12|
91756346|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|59.98|||||TWO_SIDED|95.0|49.49|69.32|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||69.32|49.49|
91510880|NCT03296163|182893522|OTHER|Hazard ratio of MB02 versus EU-approved Avastin; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in MB02; \<1 indicated an increase in PD/death in EU-approved Avastin.|Hazard Ratio (HR)|1.187|||||TWO_SIDED|95.0|0.98|1.44||||||||1.44|0.98|
91510881|NCT03296163|182893523|OTHER||Hazard Ratio (HR)|1.108|||||TWO_SIDED|95.0|0.827|1.485||||||||1.485|0.827|
91510882|NCT01959581|182893544|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Repeated measures ANOVA||||<.05
91510883|NCT03304379|182893546|SUPERIORITY||Least Square (LS) Mean Difference|-0.63|||=|0.0003|TWO_SIDED|95.0|-0.971|-0.286||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.286|-0.971|= 0.0003
91510884|NCT03304379|182893546|SUPERIORITY||LS Mean Difference|-0.77|||>|0.0001|TWO_SIDED|95.0|-1.154|-0.383||Threshold for significance at 0.05 level.|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction"||-0.383|-1.154|> 0.0001
91510885|NCT03304379|182893547|SUPERIORITY||LS Mean Difference|-0.64|||=|0.0003|TWO_SIDED|95.0|-0.981|-0.29||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.290|-0.981|= 0.0003
91510886|NCT03304379|182893547|SUPERIORITY||LS Mean Difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.198|-0.443||Threshold for significance at 0.05 level|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction."||-0.443|-1.198|<0.0001
91533813|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.0239|TWO_SIDED|95.0|-1.21|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-1.21|0.0239
91756347|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|57.37|||||TWO_SIDED|95.0|46.71|66.88|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||66.88|46.71|
91510887|NCT03304379|182893548|SUPERIORITY||Odds Ratio (OR)|1.581|||=|0.0013|TWO_SIDED|95.0|1.195|2.092||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.||2.092|1.195|= 0.0013
91510888|NCT03304379|182893549|SUPERIORITY||LS Mean Difference|-0.14|||=|0.0365|TWO_SIDED|95.0|-0.28|-0.009||Threshold for significance at 0.05 level.|MMRM|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.||-0.009|-0.28|= 0.0365
91510889|NCT03402243|182893564|SUPERIORITY||Estimated mean ratio|1.38|||||TWO_SIDED|95.0|1.1|1.75|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a total menthol ban smoked relative to those randomized to a menthol cigarette ban|||1.75|1.1|
91510890|NCT03402243|182893564|SUPERIORITY||Estimated mean ratio|0.87|||||TWO_SIDED|95.0|0.68|1.11|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol cigarettes ban relative to those randomized to no menthol ban|||1.11|0.68|
91510891|NCT03402243|182893564|SUPERIORITY||Estimated mean ratio|1.2|||||TWO_SIDED|95.0|0.99|1.45|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol ban for cigarettes and e-cigarettes relative to those randomized to no menthol ban|||1.45|0.99|
91510892|NCT03402243|182893564|SUPERIORITY|||||||0.349|||||||Kruskal-Wallis|||Average number of puffs per participants over the 6 week study period||||0.349
91533814|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.028|TWO_SIDED|95.0|-1.19|-0.07|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.07|-1.19|0.0280
91510893|NCT03402243|182893565|SUPERIORITY|||||||0.185|||||||Mixed Models Analysis|||Comparison among groups in number of cigarette packs selected||||0.185
91510894|NCT03402243|182893565|SUPERIORITY|||||||0.076|||||||Mixed Models Analysis|||Comparison among groups in number of e-cigarette liquid units selected||||0.076
91510895|NCT03402243|182893566|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
91513550|NCT03029208|182898970|SUPERIORITY||LS mean difference|-1.03||||0.7803|TWO_SIDED|95.0|-3.65|1.59|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.59|-3.65|0.7803
91513551|NCT03029208|182898970|SUPERIORITY||LS mean difference|-1.18||||0.8556|TWO_SIDED|95.0|-3.35|1.0|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||1.00|-3.35|0.8556
91513552|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.08||||0.4763|TWO_SIDED|95.0|-2.61|2.77|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.77|-2.61|0.4763
91510896|NCT02802345|182893571|SUPERIORITY||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|1.431||0.7191|TWO_SIDED|95.0|-3.33|2.3|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks).|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|"H0: There is no difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone.~Ha: There is a difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone."|2.30|-3.33|0.7191
91510897|NCT02802345|182893572|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_ERROR_OF_MEAN|2.198||0.1823|TWO_SIDED|95.0|-7.27|1.39|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.||1.39|-7.27|0.1823
91510898|NCT02802345|182893573|SUPERIORITY||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|1.631||0.1809|TWO_SIDED|95.0|-5.4|1.02|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||1.02|-5.40|0.1809
91510899|NCT02802345|182893574|SUPERIORITY||Adjusted mean difference|-2.41|STANDARD_ERROR_OF_MEAN|2.529||0.3421|TWO_SIDED|95.0|-7.39|2.58|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||2.58|-7.39|0.3421
91510900|NCT02802345|182893575|SUPERIORITY||Percentage ratio (%)|0.83|||||TWO_SIDED|95.0|0.58|1.2|||||Within strata confidence limits are calculated according to Wald. Percentage ratio = (% of Nintedanib+sildenafil) / (% of Nintedanib+placebo).|Relative risk, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||1.20|0.58|
91513553|NCT03029208|182898970|SUPERIORITY||LS mean difference|0.73||||0.3208|TWO_SIDED|95.0|-2.35|3.8|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||3.80|-2.35|0.3208
91513554|NCT03029208|182898971|SUPERIORITY||LS mean difference|-1.02||||0.791|TWO_SIDED|95.0|-3.5|1.46|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.46|-3.50|0.7910
91513555|NCT03029208|182898971|SUPERIORITY||LS mean difference|-1.45||||0.8648|TWO_SIDED|95.0|-4.03|1.14|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.14|-4.03|0.8648
91533815|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6904|TWO_SIDED|95.0|-0.7|0.46|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.46|-0.70|0.6904
91756348|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|58.69|||||TWO_SIDED|95.0|48.32|67.94|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||67.94|48.32|
91756349|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.61|||||TWO_SIDED|95.0|-1.17|6.62|||Miettinen & Nurminen score method|||Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.62|-1.17|
91756350|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|45.25|||||TWO_SIDED|95.0|35.11|55.47|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||55.47|35.11|
91756351|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|42.67|||||TWO_SIDED|95.0|32.34|53.04|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||53.04|32.34|
91756352|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|43.98|||||TWO_SIDED|95.0|33.92|54.14|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||54.14|33.92|
91756353|NCT02986854|183405255|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.58|||||TWO_SIDED|95.0|-0.86|6.3|||Miettinen & Nurminen score method|||Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.3|-0.86|
91756354|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.16|||||TWO_SIDED|95.0|1.23|13.41|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||13.41|1.23|
91756355|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|10.59|||||TWO_SIDED|95.0|3.54|16.14|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||16.14|3.54|
91756356|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|9.36|||||TWO_SIDED|95.0|2.72|13.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)||13.58|2.72|
91756357|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|-2.44|||||TWO_SIDED|95.0|-8.17|3.24|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.24|-8.17|
91756358|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.94|||||TWO_SIDED|95.0|-3.57|14.15|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||14.15|-3.57|
91756359|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.88|||||TWO_SIDED|95.0|-1.77|16.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||16.52|-1.77|
91756360|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.89|||||TWO_SIDED|95.0|-2.34|13.48|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||13.48|-2.34|
91756361|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.93|||||TWO_SIDED|95.0|-9.84|5.82|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||5.82|-9.84|
91756362|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.33|||||TWO_SIDED|95.0|30.25|54.6|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.60|30.25|
91756363|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|38.05|||||TWO_SIDED|95.0|23.93|48.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||48.58|23.93|
91756364|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.26|||||TWO_SIDED|95.0|28.15|49.72|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||49.72|28.15|
91756365|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.28|||||TWO_SIDED|95.0|-5.31|17.71|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||17.71|-5.31|
91756366|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.65|||||TWO_SIDED|95.0|19.25|37.65|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||37.65|19.25|
91756367|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.97|||||TWO_SIDED|95.0|19.6|37.95|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||37.95|19.60|
91756368|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.81|||||TWO_SIDED|95.0|19.5|37.76|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||37.76|19.50|
91756369|NCT02986854|183405261|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.32|||||TWO_SIDED|95.0|-2.56|1.86|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.86|-2.56|
91756370|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.78|||||TWO_SIDED|95.0|16.23|38.27|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.27|16.23|
91510901|NCT02802345|182893575|SUPERIORITY||Percentage difference (%)|-5.37||||0.334|TWO_SIDED|95.0|-16.25|5.52|||Cochran-Mantel-Haenszel||Within strata confidence limits are calculated according to Wald. Percentage difference = (% of Nintedanib+sildenafil) - (% of Nintedanib+placebo).|Risk difference, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||5.52|-16.25|0.334
91510902|NCT03969212|182893576|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.68|||=|0.013|TWO_SIDED|95.38|0.5|0.93|||GEE|||The odds ratio (OR) shown represents the odds of Baloxavir Marboxil (BMX) versus the odds of Placebo.||0.93|0.50|= 0.013
91756371|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.4|||||TWO_SIDED|95.0|8.78|31.03|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||31.03|8.78|
91756372|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|24.14|||||TWO_SIDED|95.0|13.28|33.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.86|13.28|
91756373|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.37|||||TWO_SIDED|95.0|-0.76|15.42|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.42|-0.76|
91756374|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.08|||||TWO_SIDED|95.0|11.04|42.14|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||42.14|11.04|
91756375|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|16.39|||||TWO_SIDED|95.0|0.04|31.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.90|0.04|
91756376|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.85|||||TWO_SIDED|95.0|6.73|36.11|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||36.11|6.73|
91756377|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|10.69|||||TWO_SIDED|95.0|-0.42|21.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||21.60|-0.42|
91756378|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.4|||||TWO_SIDED|95.0|28.65|58.93|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||58.93|28.65|
91756379|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.9|||||TWO_SIDED|95.0|33.45|63.13|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.13|33.45|
91756380|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|46.61|||||TWO_SIDED|95.0|31.52|60.59|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||60.59|31.52|
91533816|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.4022|TWO_SIDED|95.0|-0.83|0.33|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.33|-0.83|0.4022
91533817|NCT00797225|182945073|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.29||0.0451|TWO_SIDED|95.0|-1.17|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-1.17|0.0451
91510903|NCT03969212|182893577|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.75|||=|0.155|TWO_SIDED|95.38|0.5|1.12|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.12|0.50|= 0.1550
91510904|NCT03969212|182893578|OTHER||Odds Ratio (BMX vs Placebo}]|0.76|||||TWO_SIDED|95.38|0.55|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.55|
91510905|NCT03969212|182893579|OTHER||Odds Ratio (BMX vs Placebo)|0.69|||||TWO_SIDED|95.38|0.46|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.46|
91510906|NCT03969212|182893580|OTHER||Adjusted OR (BMX vs Placebo)|0.66|||||TWO_SIDED|95.38|0.48|0.91|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.91|0.48|
91510907|NCT03969212|182893581|OTHER||Adjusted OR (BMX vs Placebo)|0.73|||||TWO_SIDED|95.38|0.48|1.09|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.09|0.48|
91510908|NCT03969212|182893582|OTHER||Adjusted OR (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.53|0.94|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.94|0.53|
91510909|NCT03969212|182893583|OTHER||Odds Ratio (BMX vs Placebo)|0.79|||||TWO_SIDED|95.38|0.59|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.59|
91510910|NCT03969212|182893584|OTHER||Adjusted OR (BMX vs Placebo)|0.72|||||TWO_SIDED|95.38|0.49|1.07|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.07|0.49|
91510911|NCT03969212|182893585|OTHER||Odds Ratio (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.48|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.48|
91510912|NCT03773757|182893593|SUPERIORITY|Longitudinal measures of NPI-Q patient over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8719|||||||Mixed Models Analysis|||||||0.8719
91510913|NCT03773757|182893594|SUPERIORITY|Longitudinal measures of SM-EOLD over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8389|||||||Mixed Models Analysis|||||||0.8389
91510914|NCT03773757|182893595|SUPERIORITY|Longitudinal measures of PHQ-8 over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.3431|||||||Mixed Models Analysis|||||||0.3431
91510915|NCT03773757|182893596|SUPERIORITY|Longitudinal measures of NPI-Q caregiver distress over 24 months were compared between the two groups using mixed effects model including a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.6612|||||||Mixed Models Analysis|||||||0.6612
91510916|NCT03773757|182893597|SUPERIORITY|A zero-inflated Poisson (ZIP) model was used to compare the mean numbers of hospitalization/ED events between the two groups. The ZIP model consists of a combination of a standard Poisson distribution for count data and a binary logistic regression model to account for additional zero events exceeding what would be expected from an underlying Poisson distribution.||||||0.0007|||||||Zero-Inflated Poisson Regression Model|||||||0.0007
91510917|NCT00550836|182893612|SUPERIORITY|||||||0.36|||||||Log Rank|||It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.||||0.36
91756381|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.5|||||TWO_SIDED|95.0|-11.84|2.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||2.69|-11.84|
91510918|NCT00550836|182893613|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91510919|NCT00550836|182893614|SUPERIORITY|||||||0.419|||||||Log Rank|||||||0.419
91510920|NCT00550836|182893615|OTHER|||||||0.36|||||||Log Rank|||||||0.36
91513556|NCT03029208|182898972|SUPERIORITY||LS mean difference|-0.28||||0.5879|TWO_SIDED|95.0|-2.75|2.19|||MMRM||SF-36 HRQoL physical functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.19|-2.75|0.5879
91513557|NCT03029208|182898972|SUPERIORITY||LS mean difference|-1.43||||0.8525|TWO_SIDED|95.0|-4.12|1.26|||MMRM||SF-36 HRQoL physical functioning domain scor was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.26|-4.12|0.8525
91510921|NCT01848990|182893651|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.05||||0.4516|TWO_SIDED|95.0|-0.08|0.18|||ANOVA|Analysis of variance (ANOVA) with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 participants (Pt) being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.18|-0.08|0.4516
91510922|NCT01848990|182893652|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.14||||0.0711|TWO_SIDED|95.0|-0.01|0.28|||ANOVA|ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 Pt being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.28|-0.01|0.0711
91510923|NCT01848990|182893653|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.69||||0.0105|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0105
91510924|NCT01848990|182893653|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.79||||0.013|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0130
91510925|NCT01848990|182893653|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.78||||0.0511|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.0511
91510926|NCT01848990|182893653|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.34||||0.1176|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.1176
91510927|NCT01848990|182893654|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.81||||0.0456|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0456
91510928|NCT01848990|182893654|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.92||||0.2322|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.2322
91510929|NCT01848990|182893654|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.87||||0.1365|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.1365
91510930|NCT01848990|182893654|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.07||||0.8909|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.8909
91510931|NCT01848990|182893655|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.98||||0.7292|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7292
91510932|NCT01848990|182893655|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.95||||0.5895|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5895
91756382|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.9|||||TWO_SIDED|95.0|7.53|21.22|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||21.22|7.53|
91756383|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.55|||||TWO_SIDED|95.0|7.1|20.89|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||20.89|7.10|
91756384|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.73|||||TWO_SIDED|95.0|7.34|21.05|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||21.05|7.34|
91756385|NCT02986854|183405262|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
91756386|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.14|||||TWO_SIDED|95.0|3.46|25.39|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||25.39|3.46|
91756387|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.66|||||TWO_SIDED|95.0|5.0|26.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.89|5.00|
91510933|NCT01848990|182893656|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.04||||0.5414|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5414
91510934|NCT01848990|182893656|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.03||||0.711|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7110
91510935|NCT01848990|182893657|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-3.4||||0.5394|TWO_SIDED|95.0|-14.2|7.5||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.5|-14.2|0.5394
91510936|NCT01848990|182893657|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|4.3||||0.4151|TWO_SIDED|95.0|-6.1|14.8||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.8|-6.1|0.4151
91510937|NCT01848990|182893657|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.993|TWO_SIDED|95.0|-9.5|9.6||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||9.6|-9.5|0.9930
91510938|NCT01848990|182893657|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.941|TWO_SIDED|95.0|-6.4|6.9||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-6.4|0.9410
91510939|NCT01848990|182893658|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-4.8||||0.3239|TWO_SIDED|95.0|-14.3|4.7||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-14.3|0.3239
91510940|NCT01848990|182893658|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.754|TWO_SIDED|95.0|-7.4|10.2||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||10.2|-7.4|0.7540
91510941|NCT01848990|182893658|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.7904|TWO_SIDED|95.0|-9.5|7.2||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.2|-9.5|0.7904
91510942|NCT01848990|182893658|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.6||||0.4016|TWO_SIDED|95.0|-8.5|3.4||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||3.4|-8.5|0.4016
91510943|NCT01848990|182893659|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.4||||0.526|TWO_SIDED|95.0|-5.6|2.9|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.9|-5.6|0.5260
91510944|NCT01848990|182893660|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.5||||0.8049|TWO_SIDED|95.0|-3.7|4.7|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-3.7|0.8049
91510945|NCT01848990|182893661|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8955||||||HbA1c \<7.0%|Chi-squared|||||||0.8955
91510946|NCT01848990|182893661|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8926||||||HbA1c ≤6.5%|Chi-squared|||||||0.8926
91510947|NCT01848990|182893662|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.13||||0.7735|TWO_SIDED|95.0|-0.76|1.03|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.03|-0.76|0.7735
91510948|NCT01848990|182893663|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.4948|TWO_SIDED|95.0|-4.1|2.0||Daily bolus dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.0|-4.1|0.4948
91510949|NCT01848990|182893663|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.3||||0.1099|TWO_SIDED|95.0|-0.5|5.2||Daily basal dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||5.2|-0.5|0.1099
91510950|NCT01848990|182893663|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.583|TWO_SIDED|95.0|-3.7|6.6||Daily total dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.6|-3.7|0.5830
91510951|NCT01848990|182893664|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.8778|TWO_SIDED|95.0|-1.0|1.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.1|-1.0|0.8778
91510952|NCT01848990|182893665|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.1||||0.3233|TWO_SIDED|95.0|-6.3|2.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.1|-6.3|0.3233
91510953|NCT01848990|182893667|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.0||||0.7708|TWO_SIDED|95.0|-5.8|7.8||Average glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.8|-5.8|0.7708
91510954|NCT01848990|182893667|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.8||||0.6058|TWO_SIDED|95.0|-5.0|8.6||Median glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||8.6|-5.0|0.6058
91510955|NCT01848990|182893667|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.7||||0.6571|TWO_SIDED|95.0|-4.0|2.5||Average daily standard deviation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.5|-4.0|0.6571
91510956|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.2||||0.6252|TWO_SIDED|95.0|-11.3|6.9||Time per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-11.3|0.6252
91510957|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-5.5||||0.5929|TWO_SIDED|95.0|-25.9|14.9||Time per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.9|-25.9|0.5929
91510958|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|6.9||||0.5207|TWO_SIDED|95.0|-14.4|28.3||Time per day \>70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||28.3|-14.4|0.5207
91510959|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-23.3||||0.4754|TWO_SIDED|95.0|-87.8|41.2||Time per day \<140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||41.2|-87.8|0.4754
91510960|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|23.9||||0.4644|TWO_SIDED|95.0|-40.7|88.6||Time per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||88.6|-40.7|0.4644
91756388|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.89|||||TWO_SIDED|95.0|4.91|25.62|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||25.62|4.91|
91533818|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.48||0.0007|TWO_SIDED|95.0|-2.56|-0.69|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.69|-2.56|0.0007
91533819|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.47||0.0006|TWO_SIDED|95.0|-2.56|-0.7|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.70|-2.56|0.0006
91533820|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.47||0.0073|TWO_SIDED|95.0|-2.21|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-2.21|0.0073
91533821|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.48||0.0054|TWO_SIDED|95.0|-2.28|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-2.28|0.0054
91533822|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.01|-1.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.12|-3.01|< 0.0001
91533823|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-2.73|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.67|-1.79|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.79|-3.67|< 0.0001
91533824|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.48||0.0509|TWO_SIDED|95.0|-1.89|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-1.89|0.0509
91533825|NCT00797225|182945074|SUPERIORITY||LS mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.48||0.0046|TWO_SIDED|95.0|-2.33|-0.43|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.43|-2.33|0.0046
91533826|NCT00797225|182945074|SUPERIORITY||LS Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.26|-1.38|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.38|-3.26|< 0.0001
91756389|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.52|||||TWO_SIDED|95.0|-8.51|5.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||5.50|-8.51|
91756390|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.44|||||TWO_SIDED|95.0|5.25|34.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||34.83|5.25|
91533827|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0453|TWO_SIDED|95.0|-0.33|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.33|0.0453
91756391|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.11|||||TWO_SIDED|95.0|5.88|35.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||35.50|5.88|
91756392|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|6.53|34.58|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||34.58|6.53|
91510961|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Time per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
91756393|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.66|||||TWO_SIDED|95.0|-9.67|8.4|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||8.40|-9.67|
91756394|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.2|||||TWO_SIDED|95.0|16.78|45.45|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||45.45|16.78|
91756395|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.22|||||TWO_SIDED|95.0|21.29|49.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||49.20|21.29|
91756396|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|32.17|||||TWO_SIDED|95.0|19.3|47.13|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||47.13|19.30|
91756397|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.02|||||TWO_SIDED|95.0|-9.45|0.74|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||0.74|-9.45|
91756398|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||23.95|9.28|
91756399|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||23.95|9.28|
91756400|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.94|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||23.94|9.28|
91756401|NCT02986854|183405263|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
91756402|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.75|||||TWO_SIDED|95.0|10.19|32.25|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||32.25|10.19|
91756403|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.72|||||TWO_SIDED|95.0|3.15|25.29|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||25.29|3.15|
91756404|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.27|||||TWO_SIDED|95.0|7.44|27.92|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.92|7.44|
91756405|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.03|||||TWO_SIDED|95.0|-1.2|15.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.17|-1.20|
91756406|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.91|||||TWO_SIDED|95.0|5.57|36.37|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||36.37|5.57|
91756407|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.46|||||TWO_SIDED|95.0|6.05|37.0|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||37.00|6.05|
91510962|NCT01848990|182893668|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|18.4||||0.5151|TWO_SIDED|95.0|-37.5|74.4||Time per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||74.4|-37.5|0.5151
91510963|NCT01848990|182893669|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-33.5||||0.4216|TWO_SIDED|95.0|-115.9|48.9||Area per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||48.9|-115.9|0.4216
91510964|NCT01848990|182893669|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-84.7||||0.5697|TWO_SIDED|95.0|-379.2|209.8||Area per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||209.8|-379.2|0.5697
91756408|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.18|||||TWO_SIDED|95.0|6.89|35.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||35.38|6.89|
91756409|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.55|||||TWO_SIDED|95.0|-12.11|11.03|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.03|-12.11|
91756410|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.06|||||TWO_SIDED|95.0|24.26|54.95|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.95|24.26|
91756411|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.4|||||TWO_SIDED|95.0|26.71|57.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||57.17|26.71|
91756412|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.21|||||TWO_SIDED|95.0|26.12|55.55|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.55|26.12|
91756413|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-2.34|||||TWO_SIDED|95.0|-10.41|5.73|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||5.73|-10.41|
91756414|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.58|||||TWO_SIDED|95.0|15.26|32.08|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||32.08|15.26|
91756415|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.22|||||TWO_SIDED|95.0|14.86|31.74|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||31.74|14.86|
91756416|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.41|||||TWO_SIDED|95.0|15.08|31.9|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||31.90|15.08|
91756417|NCT02986854|183405264|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
91756418|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.23|||||TWO_SIDED|95.0|2.08|11.23|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||11.23|2.08|
91756419|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.5|||||TWO_SIDED|95.0|3.28|12.74|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||12.74|3.28|
91756420|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.86|||||TWO_SIDED|95.0|2.87|10.78|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.78|2.87|
91756421|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.27|||||TWO_SIDED|95.0|-6.1|3.49|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.49|-6.10|
91756422|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.25|||||TWO_SIDED|95.0|-3.04|12.44|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||12.44|-3.04|
91756423|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.61|||||TWO_SIDED|95.0|-2.71|13.01|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||13.01|-2.71|
91756424|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.43|||||TWO_SIDED|95.0|-2.66|10.9|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.90|-2.66|
91756425|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.36|||||TWO_SIDED|95.0|-7.27|6.43|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||6.43|-7.27|
91510965|NCT01848990|182893669|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|342.9||||0.9241|TWO_SIDED|95.0|-6772.3|7458.2||Area per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7458.2|-6772.3|0.9241
91756426|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.34|||||TWO_SIDED|95.0|28.85|50.63|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||50.63|28.85|
91756427|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|36.88|||||TWO_SIDED|95.0|24.39|46.34|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||46.34|24.39|
91510966|NCT01848990|182893669|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Area per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
91510967|NCT01848990|182893669|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|Mean Difference (Final Values)|258.2||||0.9423|TWO_SIDED|95.0|-6792.2|7308.7||Area per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Least squares mean treatment difference (Hylenex minus Standard CSII)|||7308.7|-6792.2|0.9423
91510968|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5246|TWO_SIDED|95.0|-0.7|0.4||Leisure activities|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5246
91510969|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.1||||0.638|TWO_SIDED|95.0|-0.8|0.5||Work life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.8|0.6380
91510970|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5719|TWO_SIDED|95.0|-0.7|0.4||Local or long distance travel|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5719
91510971|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.4052|TWO_SIDED|95.0|-0.8|0.3||Vacations|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.4052
91510972|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.724|TWO_SIDED|95.0|-0.4|0.6||Do physically|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.7240
91510973|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6876|TWO_SIDED|95.0|-0.4|0.6||Family life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6876
91510974|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6478|TWO_SIDED|95.0|-0.4|0.6||Friendships and social life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6478
91510975|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9744|TWO_SIDED|95.0|-0.6|0.6||Close personal relationship|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.6|0.9744
91510976|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3177|TWO_SIDED|95.0|-0.3|0.8||Sex life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.8|-0.3|0.3177
91756428|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.16|||||TWO_SIDED|95.0|27.61|46.33|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||46.33|27.61|
91756429|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.46|||||TWO_SIDED|95.0|-7.04|15.83|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||15.83|-7.04|
91756430|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.61|||||TWO_SIDED|95.0|22.68|41.79|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||41.79|22.68|
91756431|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.85|||||TWO_SIDED|95.0|21.85|41.08|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||41.08|21.85|
91756432|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.24|||||TWO_SIDED|95.0|22.39|41.38|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||41.38|22.39|
91756433|NCT02986854|183405265|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.76|||||TWO_SIDED|95.0|-1.81|3.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.52|-1.81|
91756434|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.02|||||TWO_SIDED|95.0|19.55|38.83|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.83|19.55|
91756435|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.87|||||TWO_SIDED|95.0|10.48|29.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.69|10.48|
91756436|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.5|||||TWO_SIDED|95.0|15.79|33.21|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.21|15.79|
91756437|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.14|||||TWO_SIDED|95.0|1.01|17.16|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||17.16|1.01|
91756438|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.0|||||TWO_SIDED|95.0|8.82|38.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||38.90|8.82|
91756439|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.76|||||TWO_SIDED|95.0|-0.44|29.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||29.86|-0.44|
91756440|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.48|||||TWO_SIDED|95.0|5.32|33.08|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.08|5.32|
91756441|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.24|||||TWO_SIDED|95.0|-2.45|20.68|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||20.68|-2.45|
91756442|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|50.25|||||TWO_SIDED|95.0|34.09|63.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||63.67|34.09|
91756443|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.48|||||TWO_SIDED|95.0|33.21|63.01|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.01|33.21|
91756444|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.87|||||TWO_SIDED|95.0|34.42|62.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||62.60|34.42|
91756445|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.77|||||TWO_SIDED|95.0|-8.3|9.92|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||9.92|-8.30|
91756446|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.34|39.75|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||39.75|21.34|
91756447|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.75|||||TWO_SIDED|95.0|21.32|39.74|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||39.74|21.32|
91756448|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.35|39.73|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||39.73|21.35|
91756449|NCT02986854|183405266|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.01|||||TWO_SIDED|95.0|-1.6|1.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.67|-1.60|
91756450|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.36|||||TWO_SIDED|95.0|5.85|28.67|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||28.67|5.85|
91756451|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.92|||||TWO_SIDED|95.0|6.39|29.25|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.25|6.39|
91756452|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.64|||||TWO_SIDED|95.0|6.85|28.28|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.28|6.85|
91756453|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.57|||||TWO_SIDED|95.0|-8.32|7.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||7.20|-8.32|
91756454|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.58|||||TWO_SIDED|95.0|-0.98|30.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.38|-0.98|
91756455|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.64|||||TWO_SIDED|95.0|7.3|38.16|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||38.16|7.30|
91756456|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.53|||||TWO_SIDED|95.0|4.14|33.37|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.37|4.14|
91756457|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-8.06|||||TWO_SIDED|95.0|-18.34|2.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||2.38|-18.34|
91756458|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.04|||||TWO_SIDED|95.0|23.76|54.07|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.07|23.76|
91756459|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.14|||||TWO_SIDED|95.0|27.08|56.98|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||56.98|27.08|
91756460|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.56|||||TWO_SIDED|95.0|25.91|55.15|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.15|25.91|
91756461|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-3.1|||||TWO_SIDED|95.0|-10.2|3.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||3.89|-10.20|
91510977|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.2087|TWO_SIDED|95.0|-0.2|0.7||Physical appearance|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.7|-0.2|0.2087
91510978|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.7907|TWO_SIDED|95.0|-0.4|0.5||Self-confidence|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.4|0.7907
91510979|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.3||||0.3444|TWO_SIDED|95.0|-0.8|0.3||Motivation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.3444
91510980|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.2175|TWO_SIDED|95.0|-0.1|0.6||The way people in general react|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.1|0.2175
91756462|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||28.83|12.74|
91756463|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||28.83|12.74|
91533828|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0609|TWO_SIDED|95.0|-0.31|0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.01|-0.31|0.0609
91533829|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.0069|TWO_SIDED|95.0|-0.38|-0.06|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.06|-0.38|0.0069
91533830|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0556|TWO_SIDED|95.0|-0.32|0.0|||Mixed-effects Repeated Measures Model]|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.32|0.0556
91533831|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.0387|TWO_SIDED|95.0|-0.33|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.33|0.0387
91533832|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0008|TWO_SIDED|95.0|-0.44|-0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.12|-0.44|0.0008
91533833|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5879|TWO_SIDED|95.0|-0.21|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.21|0.5879
91533834|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6122|TWO_SIDED|95.0|-0.2|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.20|0.6122
91533835|NCT00797225|182945075|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.0023|TWO_SIDED|95.0|-0.41|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-0.41|0.0023
91756464|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.75|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.83|12.75|
91756465|NCT02986854|183405267|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
91756466|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.82|||||TWO_SIDED|95.0|11.44|30.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||30.60|11.44|
91533836|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.69|< 0.0001
91756467|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.67|||||TWO_SIDED|95.0|7.34|26.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.43|7.34|
91756468|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|10.09|27.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.43|10.09|
91756469|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.15|||||TWO_SIDED|95.0|-3.8|12.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||12.04|-3.80|
91756470|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.33|||||TWO_SIDED|95.0|2.92|30.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.99|2.92|
91756471|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.3|||||TWO_SIDED|95.0|2.83|31.06|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.06|2.83|
91510981|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.4||||0.2062|TWO_SIDED|95.0|-1.0|0.2||Feelings about the future|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.0|0.2062
91510982|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.8762|TWO_SIDED|95.0|-0.5|0.6||Financial situation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.5|0.8762
91510983|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.89|TWO_SIDED|95.0|-0.5|0.5||Living situation and conditions|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.5|0.8900
91510984|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.5||||0.1367|TWO_SIDED|95.0|-1.1|0.2||Depend on others|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.1|0.1367
91510985|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3144|TWO_SIDED|95.0|-0.3|0.9||Freedom to eat|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.9|-0.3|0.3144
91510986|NCT01848990|182893670|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6869|TWO_SIDED|95.0|-0.4|0.6||Freedom to drink|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6869
91510987|NCT01848990|182893671|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9901|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.3|0.9901
91510988|NCT01848990|182893672|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.9081|TWO_SIDED|95.0|-1.1|1.3||DTSQs|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.3|-1.1|0.9081
91510989|NCT01848990|182893672|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.984|TWO_SIDED|95.0|-1.5|1.6||DTSQc|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.6|-1.5|0.9840
91510990|NCT01312766|182893703|NON_INFERIORITY_OR_EQUIVALENCE|The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.|Mean Difference (Final Values)|1.9||||0.012|TWO_SIDED|95.0|0.43|3.43|||ANOVA|||||3.43|0.43|0.012
91510991|NCT01312766|182893704|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
91510992|NCT01312766|182893706|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.90
91756472|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.31|||||TWO_SIDED|95.0|3.83|29.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||29.39|3.83|
91510993|NCT01312766|182893707|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
91510994|NCT01312766|182893710|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
91510995|NCT01312766|182893711|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
91510996|NCT01312766|182893712|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
91510997|NCT01312766|182893713|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91756473|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.03|||||TWO_SIDED|95.0|-11.35|11.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.39|-11.35|
91510998|NCT01312766|182893714|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||||||0.04
91510999|NCT01312766|182893715|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
91511000|NCT00298038|182893716|SUPERIORITY|Analysis based on the overall comparison of time to the first breakthrough overt HE episode between rifaximin and placebo groups adjusting for analysis region, using the Cox proportional hazards model (Score test, \[that is, Log rank test stratified by analysis region\]) with a 2-sided test at a significance level of 0.05 under the proportional hazards assumption.|Hazard Ratio (HR)|0.421|||<|0.0001|TWO_SIDED|95.0|0.276|0.641|||Cox proportional hazards model|||||0.641|0.276|<0.0001
91511001|NCT01940705|182893725|SUPERIORITY||Mean Difference (Final Values)|5.578||||0.001|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Skills scale||||0.001
91511002|NCT01940705|182893725|SUPERIORITY||Mean Difference (Final Values)|4.235||||0.003|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Knowledge scale||||0.003
91511003|NCT01940705|182893726|SUPERIORITY||Mean Difference (Final Values)|0.956||||0.414|TWO_SIDED||||||ANOVA|||||||0.414
91511004|NCT01940705|182893727|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.847|TWO_SIDED||||||ANOVA|||||||0.847
91511005|NCT02447991|182893728|SUPERIORITY||||||<|0.33||||||Significance level p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.33
91511006|NCT02447991|182893729|SUPERIORITY||||||<|0.18||||||Signficant at p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication||||<0.18
91511007|NCT02447991|182893730|SUPERIORITY||||||<|0.62||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.62
91511008|NCT02447991|182893731|SUPERIORITY||||||<|0.19||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportions of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.19
91756474|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.87|||||TWO_SIDED|95.0|32.64|62.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||62.38|32.64|
91511009|NCT02447991|182893732|SUPERIORITY||||||<|0.14||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.14
91511010|NCT02447991|182893733|SUPERIORITY||||||<|0.72||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.72
91511011|NCT02447991|182893734|SUPERIORITY||||||<|0.48||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.48
91511012|NCT02447991|182893735|SUPERIORITY||||||<|0.35||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication..||||<0.35
91511013|NCT02447991|182893736|SUPERIORITY||||||<|0.022||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with effectiveness of study medication||||<0.022
91511014|NCT02447991|182893736|SUPERIORITY||||||<|0.418||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with side effects of study medication||||<0.418
91511015|NCT02447991|182893736|SUPERIORITY||||||<|0.674||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with convenience of study medication||||<0.674
91511016|NCT02447991|182893736|SUPERIORITY||||||<|0.016||||||Significance of threshold of p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with overall satisfaction of study medication||||<0.016
91511017|NCT02447991|182893737|SUPERIORITY||||||<|0.009||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on physical well-being||||<0.009
91511018|NCT02447991|182893737|SUPERIORITY||||||<|0.467||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on mental well-being||||<0.467
91511019|NCT02447991|182893738|SUPERIORITY||||||<|0.013||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients.This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.||||<0.013
91511020|NCT02447991|182893738|SUPERIORITY||||||<|0.021||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness||||<0.021
91511021|NCT02447991|182893739|SUPERIORITY||||||<|0.76||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.76
91511022|NCT02447991|182893740|SUPERIORITY||||||<|0.041||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness episodes measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.041
91511023|NCT02447991|182893741|SUPERIORITY||||||<|0.12||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.12
91511024|NCT02447991|182893742|SUPERIORITY||||||<|0.051||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.051
91511025|NCT02447991|182893743|SUPERIORITY||||||<|0.006||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.006
91511026|NCT02447991|182893744|SUPERIORITY||||||<|0.67||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.67
91511027|NCT03551210|182893745|NON_INFERIORITY|The non-inferiority bound was designated at the level of -15%|Difference in percentage|6.1|||||TWO_SIDED|95.0|-0.7|13.0||||||||13.0|-0.7|
91756475|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.18|||||TWO_SIDED|95.0|31.87|61.79|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||61.79|31.87|
91756476|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.53|||||TWO_SIDED|95.0|33.04|61.31|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||61.31|33.04|
91756477|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.69|||||TWO_SIDED|95.0|-8.6|10.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||10.04|-8.60|
91756478|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|35.48|||||TWO_SIDED|95.0|26.5|45.62|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||45.62|26.50|
91756479|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.06|||||TWO_SIDED|95.0|24.94|44.28|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||44.28|24.94|
91756480|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.78|||||TWO_SIDED|95.0|25.78|44.93|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||44.93|25.78|
91756481|NCT02986854|183405268|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|1.42|||||TWO_SIDED|95.0|0.1|3.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.60|0.10|
91756482|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.39|||||TWO_SIDED|95.0|-6.08|4.94|||Miettinen & Nurminen score method|||Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)||4.94|-6.08|
91756483|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.17|||||TWO_SIDED|95.0|-5.32|6.21|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||6.21|-5.32|
91756484|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.77|||||TWO_SIDED|95.0|-5.68|4.09|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.09|-5.68|
91756485|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.79|||||TWO_SIDED|95.0|-4.98|3.01|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.01|-4.98|
91756486|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|34.76|||||TWO_SIDED|95.0|22.38|44.07|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||44.07|22.38|
91511028|NCT03551210|182893745|OTHER||Odds Ratio (OR)|1.45|||=|0.499|TWO_SIDED|95.0|0.49|4.29|||Regression, Logistic|||||4.29|0.49|=0.499
91511029|NCT03551210|182893746|OTHER||Difference in percentage|4.3|||=|0.08|TWO_SIDED|95.0|-0.6|9.7|||Barnard's test|||Visit 2||9.7|-0.6|=0.08
91511030|NCT03551210|182893746|OTHER||Difference in percentage|3.7|||=|0.246|TWO_SIDED|95.0|-2.0|9.8|||Barnard's test|||Visit 3||9.8|-2.0|=0.246
91511031|NCT03551210|182893747|OTHER||||||=|0.154|||||||Barnard test|||||||=0.154
91511032|NCT03551210|182893748|OTHER||||||=|0.14|||||||Log Rank|||||||=0.14
91511033|NCT03551210|182893749|OTHER||||||=|0.26|||||||Barnard test|||||||=0.26
91511034|NCT03551210|182893750|OTHER||||||=|0.14||||||Visit 2 assessment|Barnard's test|||||||=0.14
91511035|NCT03551210|182893750|OTHER|||||||0.515||||||Visit 3 assessment|Barnard's test|||||||0.515
91511036|NCT03551210|182893750|OTHER|||||||0.515||||||Visit 4 assessment|Barnard's test|||||||0.515
91511037|NCT01513317|182893857|SUPERIORITY_OR_OTHER||Difference in proportions|0.082||||0.271|TWO_SIDED|95.0|-0.03|0.2|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS.|||0.20|-0.03|0.271
91511038|NCT01513317|182893858|SUPERIORITY_OR_OTHER||Difference in LS means|0.07||||0.872|TWO_SIDED|95.0|-0.79|0.93|||ANCOVA||The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13.|||0.93|-0.79|0.872
91511039|NCT01513317|182893859|SUPERIORITY_OR_OTHER||Difference in proportions|0.042||||0.494|TWO_SIDED|95.0|-0.06|0.15|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13.|||0.15|-0.06|0.494
91511040|NCT01513317|182893860|SUPERIORITY_OR_OTHER||Difference in proportions|0.002||||0.986|TWO_SIDED|95.0|-0.09|0.09|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13.|||0.09|-0.09|0.986
91511041|NCT01513317|182893861|SUPERIORITY_OR_OTHER||Difference in LS means|1.96||||0.363|TWO_SIDED|95.0|-2.35|6.27|||ANCOVA||The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13.|||6.27|-2.35|0.363
91511042|NCT01513317|182893862|SUPERIORITY_OR_OTHER||Difference in LS means|-1.69||||0.073|TWO_SIDED|95.0|-3.55|0.17|||ANCOVA||The estimated parameter is the difference in LS means of the number of RBC transfusions during the 8 weeks of treament before unblinding at Week 13.|||0.17|-3.55|0.073
91511043|NCT00274716|182893908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.6||0.157|TWO_SIDED|95.0|-5.3|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-5.3|0.157
91756487|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|26.88|||||TWO_SIDED|95.0|14.67|36.13|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||36.13|14.67|
91756488|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|30.89|||||TWO_SIDED|95.0|19.42|37.97|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||37.97|19.42|
91756489|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.88|||||TWO_SIDED|95.0|-3.25|18.81|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||18.81|-3.25|
91511044|NCT00274716|182893908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.5||0.01|TWO_SIDED|95.0|-7.1|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-1.0|-7.1|0.010
91511045|NCT00274716|182893908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.6||0.042|TWO_SIDED|95.0|-6.4|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-6.4|0.042
91511046|NCT00274716|182893908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.517|TWO_SIDED|95.0|-2.1|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-2.1|0.517
91511047|NCT00274716|182893908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.602|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||2.3|-3.9|0.602
91511048|NCT00274716|182893909|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.4||0.046|TWO_SIDED|95.0|-9.7|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-9.7|0.046
91511049|NCT00274716|182893909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.108|TWO_SIDED|95.0|-8.7|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-8.7|0.108
91511050|NCT00274716|182893909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.099|TWO_SIDED|95.0|-9.0|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.8|-9.0|0.099
91511051|NCT00274716|182893909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.5||0.752|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-5.7|0.752
91511052|NCT00274716|182893909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.941|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||5.0|-4.7|0.941
91511053|NCT00274716|182893910|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.7|-2.2|<0.001
91511054|NCT00274716|182893910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.4|-1.9|0.003
91511055|NCT00274716|182893910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-1.0|-2.4|<0.001
91511056|NCT00274716|182893910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.462|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.0|-0.5|0.462
91511057|NCT00274716|182893910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.4||0.118|TWO_SIDED|95.0|-0.2|1.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.3|-0.2|0.118
91511058|NCT00274716|182893911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.059|TWO_SIDED|95.0|-3.7|0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.1|-3.7|0.059
91511059|NCT00274716|182893911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.5|-1.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-1.7|-5.5|<0.001
91756490|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.45|||||TWO_SIDED|95.0|-14.26|2.35|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.35|-14.26|
91756491|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.51|||||TWO_SIDED|95.0|-8.7|9.98|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.98|-8.70|
91511060|NCT00274716|182893911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.9||0.136|TWO_SIDED|95.0|-3.3|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.5|-3.3|0.136
91511061|NCT00274716|182893911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.686|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||1.4|-2.2|0.686
91511062|NCT00274716|182893911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.9||0.022|TWO_SIDED|95.0|-4.0|-0.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-0.3|-4.0|0.022
91511063|NCT00274716|182893912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.3||0.005|TWO_SIDED|95.0|-20.8|-3.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||-3.7|-20.8|0.005
91511064|NCT00274716|182893912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|4.4||0.066|TWO_SIDED|95.0|-16.7|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.5|-16.7|0.066
91756492|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.54|||||TWO_SIDED|95.0|-11.35|4.9|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.90|-11.35|
91756493|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-5.96|||||TWO_SIDED|95.0|-12.25|-0.57|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-0.57|-12.25|
91756494|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|40.03|||||TWO_SIDED|95.0|25.37|50.92|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.92|25.37|
91756495|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|36.84|||||TWO_SIDED|95.0|22.14|47.9|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||47.90|22.14|
91756496|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.79|47.57|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.57|24.79|
91756497|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.19|||||TWO_SIDED|95.0|-8.44|14.73|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||14.73|-8.44|
91756498|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.47|||||TWO_SIDED|95.0|-14.28|2.31|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.31|-14.28|
91756499|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.89|||||TWO_SIDED|95.0|-7.4|11.6|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||11.60|-7.40|
91756500|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|0.13|||||TWO_SIDED|95.0|-10.7|5.66|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||5.66|-10.70|
91756501|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-7.37|||||TWO_SIDED|95.0|-13.89|-1.8|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-1.80|-13.89|
91756502|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.98|||||TWO_SIDED|95.0|24.35|49.88|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||49.88|24.35|
91756503|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|37.92|||||TWO_SIDED|95.0|23.23|48.95|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||48.95|23.23|
91756504|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.8|47.56|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.56|24.80|
91756505|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.06|||||TWO_SIDED|95.0|-10.51|12.6|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||12.60|-10.51|
91756506|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.75|||||TWO_SIDED|95.0|0.15|13.36|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||13.36|0.15|
91756507|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|4.38|||||TWO_SIDED|95.0|-3.15|9.24|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.24|-3.15|
91511065|NCT00274716|182893912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|4.5||0.319|TWO_SIDED|95.0|-13.4|4.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||4.4|-13.4|0.319
91533837|NCT00797225|182945076|SUPERIORITY||LS mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.73|-0.27|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.27|-0.73|< 0.0001
91511066|NCT00274716|182893912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.4||0.077|TWO_SIDED|95.0|-16.4|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.8|-16.4|0.077
91511067|NCT00274716|182893912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|4.4||0.418|TWO_SIDED|95.0|-12.2|5.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||5.1|-12.2|0.418
91511068|NCT00274716|182893913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.5||0.015|TWO_SIDED|95.0|-11.3|-1.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.2|-11.3|0.015
91511069|NCT00274716|182893913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|2.6||0.124|TWO_SIDED|95.0|-9.2|1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||1.1|-9.2|0.124
91511070|NCT00274716|182893913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.6||0.429|TWO_SIDED|95.0|-3.1|7.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||7.2|-3.1|0.429
91511071|NCT00274716|182893913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|2.5||0.001|TWO_SIDED|95.0|-13.3|-3.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-3.4|-13.3|0.001
91511072|NCT00274716|182893913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.5||0.018|TWO_SIDED|95.0|-11.1|-1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.1|-11.1|0.018
91533838|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.25|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.25|-0.71|< 0.0001
91533839|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.23|-0.69|< 0.0001
91533840|NCT00797225|182945076|SUPERIORITY||LS mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.87|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-0.87|< 0.0001
91533841|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.59|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.59|-1.04|< 0.0001
91533842|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.65|-0.18|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.18|-0.65|0.0005
91533843|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.76|-0.29|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.29|-0.76|< 0.0001
91533844|NCT00797225|182945076|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.56|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.56|-1.02|< 0.0001
91533845|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0011
91533846|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0010
91533847|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.57|-0.19|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.19|-0.57|< 0.0001
91533848|NCT00797225|182945077|SUPERIORITY||-0.33|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0007|TWO_SIDED|95.0|-0.52|-0.14|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.14|-0.52|0.0007
91533849|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.62|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.62|< 0.0001
91756508|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|6.09|||||TWO_SIDED|95.0|-1.41|9.55|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.55|-1.41|
91756509|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.37|||||TWO_SIDED|95.0|-2.48|9.54|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||9.54|-2.48|
91756510|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|39.86|||||TWO_SIDED|95.0|25.76|50.29|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.29|25.76|
91756511|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|48.05|||||TWO_SIDED|95.0|33.89|58.34|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||58.34|33.89|
91756512|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|43.91|||||TWO_SIDED|95.0|30.79|52.37|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||52.37|30.79|
91756513|NCT02986854|183405269|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-8.19|||||TWO_SIDED|95.0|-19.61|3.45|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.45|-19.61|
91511073|NCT00274716|182893914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|9.0||0.587|TWO_SIDED|95.0|-12.9|22.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||22.8|-12.9|0.587
91511074|NCT00274716|182893914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|9.2||0.562|TWO_SIDED|95.0|-23.5|12.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||12.8|-23.5|0.562
91511075|NCT00274716|182893914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|9.2||0.802|TWO_SIDED|95.0|-15.8|20.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.4|-15.8|0.802
91511076|NCT00274716|182893914|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|9.0||0.772|TWO_SIDED|95.0|-15.2|20.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.5|-15.2|0.772
91511077|NCT00274716|182893914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|9.2||0.409|TWO_SIDED|95.0|-25.9|10.6|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||10.6|-25.9|0.409
91511078|NCT01257204|182893919|SUPERIORITY_OR_OTHER||Difference|20.8|||||TWO_SIDED|80.0|4.9|36.8|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.8|4.9|
91511079|NCT01257204|182893919|SUPERIORITY_OR_OTHER||Difference|20.1|||||TWO_SIDED|80.0|3.9|36.3|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.3|3.9|
91511080|NCT01257204|182893928|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|80.0|-6.8|26.7|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||26.7|-6.8|
91511081|NCT01257204|182893928|SUPERIORITY_OR_OTHER||Difference|7.4|||||TWO_SIDED|80.0|-9.4|24.2|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||24.2|-9.4|
91511082|NCT01268644|182893942|SUPERIORITY|||||||0.14||||||P value comparing baseline to week 12|Mixed Models Analysis|||||||0.14
91511083|NCT01268644|182893943|SUPERIORITY|||||||0.01||||||P value comparing week 0 with week 12.|Mixed Models Analysis|||||||0.01
91511084|NCT01268644|182893944|SUPERIORITY|||||||0.009||||||P value comparing week 0 to week 12.|Mixed Models Analysis|||||||0.009
91511085|NCT01268644|182893945|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||||||0.75
91511086|NCT01222494|182893950|SUPERIORITY|||||||0.01||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.01
91511087|NCT01222494|182893951|SUPERIORITY|||||||0.04||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.04
91511088|NCT01222494|182893952|SUPERIORITY|||||||0.7||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.70
91511089|NCT01222494|182893953|SUPERIORITY|||||||0.003||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.003
91511090|NCT01174030|182893956|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.392|||<|0.001||95.0|2.637|26.71|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||26.710|2.637|<0.001
91511091|NCT01174030|182893956|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.269||||0.549||95.0|0.586|2.747|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||2.747|0.586|0.549
91511092|NCT01174030|182893956|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.738||||0.027||95.0|1.097|12.742|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||12.742|1.097|0.027
91511093|NCT01174030|182893957|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.683||||0.003||95.0|1.388|5.188|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model||||5.188|1.388|.003
91511094|NCT01174030|182893957|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.892||||0.056||95.0|0.98|3.651|||GEE: Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.651|0.980|0.056
91511095|NCT01174030|182893957|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.885||||0.074||95.0|0.946|3.756|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.756|0.946|0.074
91511096|NCT01174030|182893958|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.582|||<|0.001||95.0|2.755|15.723|||GEE: Logit link function|Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||15.723|2.755|<0.001
91511097|NCT01174030|182893958|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.853||||0.093||95.0|0.903|3.802|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.802|0.903|0.093
91511098|NCT01174030|182893958|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.365||||0.054||95.0|0.96|5.825|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||5.825|0.960|0.054
91511099|NCT03779997|182893967|SUPERIORITY||Risk Ratio (RR)|0.78|STANDARD_DEVIATION|0.1||0.07|TWO_SIDED|95.0|0.6|1.02||0.05 a priori threshold for statistical significance.|Log-linear GEE regression|||Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.||1.02|0.60|0.07
91511100|NCT03779997|182893968|SUPERIORITY||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.11||0.2|TWO_SIDED|95.0|0.65|1.1||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.||1.10|0.65|0.20
91511101|NCT03779997|182893969|SUPERIORITY||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.17||0.18|TWO_SIDED|95.0|0.45|1.16||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.||1.16|0.45|0.18
91511102|NCT03779997|182893970|SUPERIORITY||Median Difference (Final Values)|0.9|STANDARD_DEVIATION|0.45||0.31|TWO_SIDED|95.0|-0.9|2.7||0.05 a priori threshold for statistical significance.|t-test, 2 sided||TAU is the reference group.|Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.||2.7|-0.9|0.31
91511103|NCT03779997|182893971|SUPERIORITY||Risk Ratio (RR)|0.71|STANDARD_DEVIATION|0.41||0.57|TWO_SIDED|95.0|0.23|2.26||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.||2.26|0.23|0.57
91511104|NCT03779997|182893972|SUPERIORITY||Risk Ratio (RR)|1.01|STANDARD_DEVIATION|0.066||0.88|TWO_SIDED|95.0|0.89|1.15||0.05 a priori threshold for statistical significance.|GEE Poisson regression||TAU is the reference group.|Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.||1.15|0.89|0.88
91511105|NCT03779997|182893974|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_DEVIATION|0.6||0.77|TWO_SIDED|95.0|0.42|3.24||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.||3.24|0.42|0.77
91511106|NCT03779997|182893975|SUPERIORITY||Risk Ratio (RR)|0.67|STANDARD_DEVIATION|0.26||0.3|TWO_SIDED|95.0|0.32|1.43||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.||1.43|0.32|0.30
91511107|NCT03779997|182893976|SUPERIORITY||Median Difference (Final Values)|0.02|STANDARD_DEVIATION|0.07||0.91|TWO_SIDED|95.0|-0.29|0.32||0.05 a priori threshold for statistical significance|t-test, 2 sided||TAU is the reference group|Null hypothesis: No difference between arms in mean treatment satisfaction scores||0.32|-0.29|0.91
91511108|NCT04086472|182893977|SUPERIORITY||Least squares (LS) Mean Difference|-1.31||||0.808|TWO_SIDED|90.0|-10.25|7.64|||ANOVA|||Treatment vs. Placebo||7.64|-10.25|0.808
91511109|NCT04086472|182893977|SUPERIORITY||LS Mean Difference|-6.51||||0.229|TWO_SIDED|90.0|-15.46|2.43|||ANOVA|||Treatment vs. Placebo||2.43|-15.46|0.229
91511110|NCT04086472|182893977|SUPERIORITY||LS Mean Difference|-4.81||||0.363|TWO_SIDED|90.0|-13.58|3.96|||ANOVA|||Treatment vs. Placebo||3.96|-13.58|0.363
91511111|NCT04086472|182893977|SUPERIORITY||LS Mean Difference|-5.92||||0.273|TWO_SIDED|90.0|-14.87|3.02|||ANOVA|||Treatment vs. Placebo||3.02|-14.87|0.273
91511112|NCT04086472|182893978|OTHER|Treatment vs. Placebo|Difference in percentage|0.51|||||TWO_SIDED|95.0|-36.57|37.78|||||95% CI based on the Chan and Zhang exact method|||37.78|-36.57|
91511113|NCT04086472|182893978|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|||15.53|-56.70|
91511114|NCT04086472|182893978|OTHER|Treatment vs. Placebo|Difference in percentage|-17.62|||||TWO_SIDED|95.0|-53.09|20.01|||||95% CI based on the Chan and Zhang exact method|||20.01|-53.09|
91511115|NCT04086472|182893978|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|Treatment vs. Placebo||15.53|-56.70|
91511116|NCT00436280|182894006|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.512|||||TWO_SIDED|95.0|0.217|1.206|||||Comparing GCB versus non-GCB|Comparing GCB versus non-GCB||1.206|0.217|
91511117|NCT00436280|182894007|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.388|1.989|||||Comparing High Expression versus Low Expression|Comparing High Expression versus Low Expression||1.989|0.388|
91511118|NCT01663259|182894018|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
91511119|NCT01663259|182894019|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
91511120|NCT01663259|182894020|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
91756514|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.26|||||TWO_SIDED|95.0|0.93|1.7||||||Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)||1.70|0.93|
91533850|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.73|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-0.73|< 0.0001
91756515|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.34|||||TWO_SIDED|95.0|0.98|1.82||||||Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)||1.82|0.98|
91756516|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.29|||||TWO_SIDED|95.0|0.97|1.72||||||Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||1.72|0.97|
91756517|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.17|0.76|
91756518|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|5.19|||||TWO_SIDED|95.0|2.84|9.47||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||9.47|2.84|
91756519|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.1|||||TWO_SIDED|95.0|2.24|7.5||||||Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||7.50|2.24|
91511121|NCT01532687|182894023|SUPERIORITY|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.017|||||||Gehan-Wilcoxon|||Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.||||0.017
91511122|NCT01532687|182894023|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.195|||||||Gehan-Wilcoxon|||Comparison between the two arms for the liposarcoma subgroup||||0.195
91511123|NCT01532687|182894023|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.079|||||||Gehan-Wilcoxon|||Statistical results are for the 'other' sarcoma subgroup (n = 38)||||0.079
91511124|NCT01532687|182894025|SUPERIORITY|Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups||||||0.5||||||Yate's continuity correction was applied because of the number of subjects and successes (n = 4)|One-sided Proportions Test|||Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)||||0.5
91511125|NCT01532687|182894025|SUPERIORITY|||||||0.3||||||Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.||||0.3
91511126|NCT01532687|182894025|SUPERIORITY|||||||0.8||||||Yate's continuity correction was applied because of the small number of participants and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.||||0.8
91511127|NCT01532687|182894026|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.481|||||||Gehan-Wilcoxon|||Overall survival estimated among all randomized participants (n = 54)||||0.481
91511128|NCT01532687|182894026|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.353|||||||Gehan-Wilcoxon|||Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)||||0.353
91533851|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.1319|TWO_SIDED|95.0|-0.34|0.04|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.04|-0.34|0.1319
91533852|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.0222|TWO_SIDED|95.0|-0.42|-0.03|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.03|-0.42|0.0222
91756520|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.62|||||TWO_SIDED|95.0|2.62|8.15||||||Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||8.15|2.62|
91756521|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.27|||||TWO_SIDED|95.0|0.84|1.91||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.91|0.84|
91756522|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.54|||||TWO_SIDED|95.0|4.84|8.85||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||8.85|4.84|
91756523|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.37|||||TWO_SIDED|95.0|5.44|9.98||||||Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||9.98|5.44|
91756524|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.94|||||TWO_SIDED|95.0|5.23|9.21||||||Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.21|5.23|
91756525|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.72|
91756526|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|between group GMT ratios|3.43|||||TWO_SIDED|95.0|1.95|6.04||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||6.04|1.95|
91756527|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.21|3.77||||||Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||3.77|1.21|
91756528|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.72|||||TWO_SIDED|95.0|1.6|4.64||||||Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.64|1.60|
91756529|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.61|||||TWO_SIDED|95.0|1.07|2.4||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||2.40|1.07|
91756530|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.75|||||TWO_SIDED|95.0|7.51|25.19||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||25.19|7.51|
91756531|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.42|||||TWO_SIDED|95.0|7.31|24.66||||||Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||24.66|7.31|
91756532|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.59|||||TWO_SIDED|95.0|7.7|24.0||||||Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||24.00|7.70|
91756533|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.02|||||TWO_SIDED|95.0|0.67|1.56||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.56|0.67|
91511129|NCT01532687|182894026|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.408|||||||Gehan-Wilcoxon|||Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)||||0.408
91511130|NCT04116229|182894027|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI restricted fraction, or putative cellularity, than people with obesity.~Null hypothesis: DBSI restricted fraction, or putative cellularity, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.05||||0.28|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.28
91511131|NCT04116229|182894027|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI hindered fraction, or putative vasogenic edema, than people with obesity.~Null hypothesis: DBSI hindered fraction, or putative vasogenic edema, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.18||||0.03|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.03
91756534|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|19.43|||||TWO_SIDED|95.0|13.73|27.51||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||27.51|13.73|
91756535|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|17.72|||||TWO_SIDED|95.0|12.5|25.12||||||Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||25.12|12.50|
91756536|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|18.57|||||TWO_SIDED|95.0|13.4|25.73||||||Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||25.73|13.40|
91756537|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.1|||||TWO_SIDED|95.0|0.86|1.4||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.40|0.86|
91756538|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.88|||||TWO_SIDED|95.0|1.13|3.11||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||3.11|1.13|
91756539|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.46|||||TWO_SIDED|95.0|1.48|4.08||||||Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.08|1.48|
91511132|NCT04116229|182894028|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Crystallized cogntive function is not related to DBSI HF."|Slope|-0.69||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
91511133|NCT04116229|182894028|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Fluid cogntive function is not related to DBSI HF."|Slope|0.52||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
91533853|NCT00797225|182945077|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.66|-0.28|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.28|-0.66|< 0.0001
91533854|NCT02408965|182945097|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
91533855|NCT02408965|182945098|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91533856|NCT02408965|182945099|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
91533857|NCT02408965|182945100|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
91533858|NCT02408965|182945101|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
91533859|NCT02408965|182945102|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
91533860|NCT02408965|182945103|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91533861|NCT02408965|182945104|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
91756540|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.33|3.44||||||Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||3.44|1.33|
91533862|NCT02408965|182945105|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
91533863|NCT04833855|182945108|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|2.2||0.99|TWO_SIDED|95.0|-4.3|4.4||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 210 mg SC Q4W - Placebo|||4.4|-4.3|0.99
91533864|NCT04833855|182945108|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|2.2||0.6|TWO_SIDED|95.0|-5.4|3.1||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 420 mg SC Q2W - Placebo|||3.1|-5.4|0.60
91756541|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.53|
91756542|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.04|||||TWO_SIDED|95.0|4.05|12.22||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||12.22|4.05|
91533865|NCT03682536|182945133|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|2.0|4.8|||Cochran-Mantel-Haenszel|||||4.8|2.0|<.0001
91756543|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|8.99|||||TWO_SIDED|95.0|5.16|15.66||||||Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||15.66|5.16|
91533866|NCT03682536|182945134|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0003|TWO_SIDED|95.0|1.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|1.4|0.0003
91533867|NCT03682536|182945136|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.8|4.5|||Cochran-Mantel-Haenszel|||||4.5|1.8|<.0001
91533868|NCT03682536|182945138|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|1.6|<.0001
91533869|NCT03682536|182945139|SUPERIORITY||Hazard Ratio (HR)|0.534||||0.0096|TWO_SIDED|95.0|0.33|0.864|||Log Rank||Calculated by Cox proportional hazard model|||0.864|0.330|0.0096
91533870|NCT03682536|182945143|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0007|TWO_SIDED|95.0|1.4|3.8|||Cochran-Mantel-Haenszel|||||3.8|1.4|0.0007
91533871|NCT03682536|182945144|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.6|4.3|||Cochran-Mantel-Haenszel|||||4.3|1.6|<.0001
91533872|NCT02084082|182945174|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|100.37|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|96.562|104.326|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.326|96.562|<0.0001
91533873|NCT02084082|182945174|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio (net)|94.7|STANDARD_ERROR_OF_MEAN|1.037||0.0004|TWO_SIDED|90.0|88.712|101.089|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000 Fed/ L+M 1000 Fed)|||101.089|88.712|0.0004
91533874|NCT02084082|182945175|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|108.09|STANDARD_ERROR_OF_MEAN|1.054||0.0038|TWO_SIDED|90.0|99.022|117.989|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||117.989|99.022|0.0038
91533875|NCT02084082|182945175|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.24|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.067|102.597|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||102.597|94.067|<0.0001
91533876|NCT02084082|182945176|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|99.99|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|93.03|107.47|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.47|93.03|<0.0001
91533877|NCT02084082|182945176|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.95|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|92.24|101.89|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||101.89|92.24|<0.0001
91533878|NCT02084082|182945177|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.77|STANDARD_ERROR_OF_MEAN|1.046|<|0.0001|TWO_SIDED|90.0|92.464|107.645|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.645|92.464|<0.0001
91533879|NCT02084082|182945177|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.97|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.95|103.16|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.160|94.950|<0.0001
91533880|NCT02084082|182945178|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.72|STANDARD_ERROR_OF_MEAN|1.028|<|0.0001|TWO_SIDED|90.0|95.163|104.493|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.493|95.163|<0.0001
91533881|NCT02084082|182945178|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.36|STANDARD_ERROR_OF_MEAN|1.132||0.0778|TWO_SIDED|90.0|77.082|122.963|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||122.963|77.082|0.0778
91533882|NCT02084082|182945179|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.11|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.37|106.35|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||106.35|92.37|<0.0001
91533883|NCT02084082|182945179|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|93.34|103.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.27|93.34|<0.0001
91533884|NCT01822821|182945196|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was tested using a noninferiority margin of 1.15.|ratio of geometric means|0.89||||0.08|ONE_SIDED|90.0||1.06|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.06||0.08
91756544|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.94|||||TWO_SIDED|95.0|4.72|13.35||||||Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||13.35|4.72|
91533885|NCT01822821|182945196|SUPERIORITY_OR_OTHER||ratio of geometric means|0.89||||0.28|ONE_SIDED|95.0||1.1|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.10||0.28
91533886|NCT01822821|182945197|NON_INFERIORITY_OR_EQUIVALENCE|We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.|Median Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|90.0||-0.5|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.5||< 0.001
91533887|NCT01822821|182945197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|95.0||-0.42|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.42||< 0.001
91533888|NCT01822821|182945198|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||0.35|TWO_SIDED|99.4|0.34|1.7|||Regression, Logistic||Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.|||1.7|0.34|0.35
91533889|NCT01822821|182945199|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.13|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 8 hours after surgery.||0|0|0.13
91756545|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.78|||||TWO_SIDED|95.0|0.54|1.14||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.14|0.54|
91533890|NCT01822821|182945199|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.44|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 16 hours after surgery.||0|0|0.44
91533891|NCT01822821|182945199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.38|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 24 hours after surgery||0|0|0.38
91533892|NCT01822821|182945200|SUPERIORITY_OR_OTHER||ratio of geometric means|1.3||||0.46|TWO_SIDED|99.4|0.52|3.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||3.20|0.52|0.46
91533893|NCT01822821|182945201|SUPERIORITY_OR_OTHER||ratio of geometric means|0.93||||0.38|TWO_SIDED|99.4|0.74|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.74|0.38
91533894|NCT01822821|182945202|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.12|TWO_SIDED|99.4|0.94|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.94|0.12
91533895|NCT01822821|182945203|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.31|TWO_SIDED|99.4|0.9|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.9|0.31
91533896|NCT01822821|182945204|SUPERIORITY_OR_OTHER||ratio of geometric means|1.0||||0.98|TWO_SIDED|99.4|0.8|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.8|0.98
91533897|NCT01822821|182945205|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.4|TWO_SIDED|99.4|0.87|1.3|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.3|0.87|0.40
91533898|NCT02322775|182945206|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.08||||0.04|TWO_SIDED|95.0|0.0|0.15||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||The null hypothesis was: H0: Change from baseline in pre-bronchodilator FEV1 (L) at Week 12 (benralizumab vs placebo)=0.||0.15|0|0.040
91533899|NCT02322775|182945207|SUPERIORITY_OR_OTHER||Difference of Least Square Means|8.84||||0.233|TWO_SIDED|95.0|-5.74|23.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||23.42|-5.74|0.233
91533900|NCT02322775|182945208|SUPERIORITY_OR_OTHER||Difference of Least Square Means|5.29||||0.456|TWO_SIDED|95.0|-8.67|19.25||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||19.25|-8.67|0.456
91533901|NCT02322775|182945209|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.13||||0.266|TWO_SIDED|95.0|-0.35|0.1||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.10|-0.35|0.266
91533902|NCT02322775|182945210|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36||||0.2|TWO_SIDED|95.0|-0.91|0.19||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.19|-0.91|0.200
91533903|NCT02322775|182945211|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.03||||0.38|TWO_SIDED|95.0|-0.08|0.03||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.03|-0.08|0.380
91533904|NCT02322775|182945212|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.17||||0.114|TWO_SIDED|95.0|-0.39|0.04||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.04|-0.39|0.114
91533905|NCT02322775|182945214|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.21||||0.055|TWO_SIDED|95.0|0.0|0.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Total score||0.42|0|0.055
91533906|NCT02322775|182945214|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.23||||0.063|TWO_SIDED|95.0|-0.01|0.47||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Symptoms score||0.47|-0.01|0.063
91533907|NCT02322775|182945214|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.2||||0.061|TWO_SIDED|95.0|-0.01|0.41||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Activity limitation score||0.41|-0.01|0.061
91533908|NCT02322775|182945214|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.156|TWO_SIDED|95.0|-0.07|0.45||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Emotional function score||0.45|-0.07|0.156
91533909|NCT02322775|182945214|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.135|TWO_SIDED|95.0|-0.06|0.44||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Environmental stimuli score||0.44|-0.06|0.135
91756546|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|25.21|||||TWO_SIDED|95.0|17.83|35.65||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||35.65|17.83|
91756547|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|34.06|||||TWO_SIDED|95.0|24.06|48.23||||||Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||48.23|24.06|
91511134|NCT04116229|182894028|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Crystallized cognitive function is not related to DBSI RF."|Slope|-0.45||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
91756548|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|29.24|||||TWO_SIDED|95.0|21.09|40.52||||||Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||40.52|21.09|
91511135|NCT04116229|182894028|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Fluid cognitive function is not related to DBSI RF."|Slope|0.22||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
91756549|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.74|||||TWO_SIDED|95.0|0.58|0.94||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||0.94|0.58|
91756550|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.35|||||TWO_SIDED|95.0|1.36|4.07||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||4.07|1.36|
91756551|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.62|||||TWO_SIDED|95.0|1.51|4.54||||||Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.54|1.51|
91756552|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.48|||||TWO_SIDED|95.0|1.48|4.14||||||Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.14|1.48|
91756553|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.9|||||TWO_SIDED|95.0|0.61|1.33||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.33|0.61|
91756554|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.82|||||TWO_SIDED|95.0|5.47|17.64||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||17.64|5.47|
91756555|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.55|||||TWO_SIDED|95.0|5.31|17.19||||||Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||17.19|5.31|
91756556|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.69|||||TWO_SIDED|95.0|5.59|16.79||||||Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||16.79|5.59|
91756557|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.03|||||TWO_SIDED|95.0|0.69|1.54||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.54|0.69|
91756558|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|28.52|||||TWO_SIDED|95.0|20.23|40.2||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||40.20|20.23|
91756559|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|26.94|||||TWO_SIDED|95.0|19.09|38.02||||||Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||38.02|19.09|
91756560|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|27.73|||||TWO_SIDED|95.0|20.1|38.26||||||Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||38.26|20.10|
91756561|NCT02986854|183405270|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.06|||||TWO_SIDED|95.0|0.83|1.35||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.35|0.83|
91756562|NCT02039856|183405282|SUPERIORITY|Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.|Odds Ratio (OR)|0.913|STANDARD_ERROR_OF_MEAN|0.175||0.637|TWO_SIDED|95.0|0.627|1.33|||difference-in-differences analysis||The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.|Change in the odds of achieving a higher WH-PACT element.||1.33|0.627|0.637
91533910|NCT04739423|182945217|OTHER||Least Squares Mean|5.4822||||0.0479|TWO_SIDED|95.0|0.0575|10.9069|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14.||10.9069|0.0575|0.0479
91533911|NCT04739423|182945217|OTHER||Least Squares Mean|4.7954||||0.0161|TWO_SIDED|95.0|0.9843|8.6064|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6064|0.9843|0.0161
91533912|NCT04739423|182945217|OTHER||Least Squares Mean|167.29||||0.0237|TWO_SIDED|95.0|25.36|309.23|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||309.23|25.36|0.0237
91533913|NCT04739423|182945217|OTHER||Least Squares Mean|-1.2761||||0.7188|TWO_SIDED|95.0|-9.2424|6.6902|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14||6.6902|-9.2424|0.7188
91533914|NCT04739423|182945217|OTHER||Least Squares Mean|1.8955||||0.5478|TWO_SIDED|95.0|-4.9026|8.6935|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6935|-4.9026|0.5478
91533915|NCT04739423|182945217|OTHER||Least Squares Mean|-7.52||||0.951|TWO_SIDED|95.0|-291.21|276.17|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||276.17|-291.21|0.9510
91533916|NCT04739423|182945219|OTHER||Least Squares Mean|0.68||||0.0737|TWO_SIDED|95.0|-0.066|1.432|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.432|-0.066|0.0737
91533917|NCT04739423|182945219|OTHER||Least Squares Mean|1.12||||0.0033|TWO_SIDED|95.0|0.382|1.868|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||1.868|0.382|0.0033
91533918|NCT04739423|182945219|OTHER||Least Squares Mean|1.72||||0.0029|TWO_SIDED|95.0|0.6|2.84|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||2.840|0.600|0.0029
91533919|NCT04739423|182945219|OTHER||Least Squares Mean|1.29||||0.0247|TWO_SIDED|95.0|0.168|2.418|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.418|0.168|0.0247
91533920|NCT04739423|182945219|OTHER||Least Squares Mean|1.69||||0.0016|TWO_SIDED|95.0|0.653|2.732|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.732|0.653|0.0016
91533921|NCT04739423|182945219|OTHER||Least Squares Mean|-0.06||||0.9126|TWO_SIDED|95.0|-1.127|1.009|||Mixed Models Analysis|||Between treatment analysis for Immediate Word recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.009|-1.127|0.9126
91533922|NCT04739423|182945219|OTHER||Least Squares Mean|-0.24||||0.657|TWO_SIDED|95.0|-1.317|0.837|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||0.837|-1.317|0.6570
91756563|NCT02039856|183405283|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.1195||0.006|TWO_SIDED|95.0|0.1|0.57|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in gender sensitivity score between EBQI and control over time||0.57|0.10|0.006
91759876|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.72|||||TWO_SIDED|95.0|0.03|15.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.42|0.03|
91533923|NCT04739423|182945219|OTHER||Least Squares Mean|-0.06||||0.9458|TWO_SIDED|95.0|-1.787|1.669|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.669|-1.787|0.9458
91533924|NCT04739423|182945219|OTHER||Least Squares Mean|0.97||||0.2327|TWO_SIDED|95.0|-0.642|2.579|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.579|-0.642|0.2327
91533925|NCT04739423|182945219|OTHER||Least Squares Mean|0.84||||0.4154|TWO_SIDED|95.0|-1.208|2.879|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to day 7, 4 hours post-dose||2.879|-1.208|0.4154
91533926|NCT04739423|182945220|OTHER||Least Squares Mean|5.06|||<|0.0001|TWO_SIDED|95.0|3.956|6.16|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for Sleeping Heart Rate change from baseline across periods||6.160|3.956|<0.0001
91533927|NCT04739423|182945221|OTHER||Least Squares Mean|1.0||||0.0017|TWO_SIDED|95.0|0.432|1.565|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV change from baseline across periods.||1.565|0.432|0.0017
91533928|NCT04739423|182945222|OTHER||Least Squares Mean|-10.22||||0.0049|TWO_SIDED|95.0|-16.867|-3.567|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV root mean square of successive differences change from baseline across periods||-3.567|-16.867|0.0049
91533929|NCT00665561|182945241|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.42|0.67||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.||0.67|0.42|
91533930|NCT00665561|182945242|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.12|5.88||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||5.88|0.12|
91533931|NCT00665561|182945243|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.66|1.33||||||All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.33|0.66|
91533932|NCT00665561|182945243|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.29|1.31||||||AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.31|0.29|
91533933|NCT00665561|182945243|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.71|1.58||||||Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.58|0.71|
91533934|NCT00665561|182945244|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.44|2.18||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.18|0.44|
91533935|NCT00665561|182945245|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.51|1.59||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.59|0.51|
91756564|NCT02039856|183405284|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.2253||0.055|TWO_SIDED|95.0|-0.01|0.87|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in team functioning score between EBQI and control over time.||0.87|-0.01|0.055
91756565|NCT02039856|183405285|SUPERIORITY|We adjusted our analysis using the population weights, which were the product of design weights and non-response weights|Odds Ratio (OR)|0.36|STANDARD_ERROR_OF_MEAN|0.1922||0.058|TWO_SIDED|95.0|0.13|1.04|||Regression, Logistic||The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.|||1.04|0.13|0.058
91756566|NCT02039856|183405286|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.56||0.008|TWO_SIDED|95.0|0.14|2.36|||Regression, Linear||The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient primary care visits between EBQI and control over time||2.36|0.14|0.008
91756567|NCT02039856|183405287|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.413||0|TWO_SIDED|95.0|0.88|2.51|||Regression, Linear||The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient visits to women's health care between EBQI and control over time||2.51|0.88|0.000
91756568|NCT02039856|183405288|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.068||0.794|TWO_SIDED|95.0|-0.15|0.12|||Regression, Linear||The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient hospitalization for any cause between EBQI and control over time||0.12|-0.15|0.794
91759877|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.16|||||TWO_SIDED|95.0|-4.54|10.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.87|-4.54|
91759878|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.97|||||TWO_SIDED|95.0|-1.77|13.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.71|-1.77|
91759879|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-6.75|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-6.75|
91759880|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.57|14.43||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.43|0.57|
91759881|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|||||TWO_SIDED|95.0|-6.26|7.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.64|-6.26|
91533936|NCT00665561|182945246|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.7|1.76||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.76|0.70|
91533937|NCT00665561|182945247|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.25|4.93||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||4.93|0.25|
91533938|NCT00665561|182945248|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.18|2.47||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.47|0.18|
91533939|NCT00665561|182945249|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.57|1.08||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.08|0.57|
91756569|NCT02039856|183405289|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.15||0.888|TWO_SIDED|95.0|-0.265|0.306|||Regression, Linear||The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of emergency room visits for any cause between EBQI and control over time||0.306|-0.265|0.888
91756570|NCT01174173|183405308|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||A two-sided t-test was performed with p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.0013
91756571|NCT01174173|183405309|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||A two-sided t-test was performed for change in 6-minute walk test and p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.09
91756572|NCT01174173|183405310|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of \<0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.37
91756573|NCT01174173|183405312|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
91756574|NCT01174173|183405313|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
91756575|NCT03335774|183405314|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8918|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8918
91756576|NCT03335774|183405315|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8323|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8323
91756577|NCT00746863|183405320|SUPERIORITY_OR_OTHER|||||||0.0251||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0251
91756578|NCT00746863|183405321|SUPERIORITY_OR_OTHER|||||||0.0923||95.0||||Adjusted for multiple comparisions|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0923
91756579|NCT00746863|183405322|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Chi-squared|||Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge||||0.4756
91756580|NCT00746863|183405323|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.258
91756581|NCT00746863|183405324|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.435
91756582|NCT00082407|183405372|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and biphasic insulin aspart is less than 0.4%.)|Mean Difference (Final Values)|-0.1||||0.2534||95.0|-0.28|0.08|||ANCOVA|||||0.08|-0.28|0.2534
91756583|NCT00082407|183405373|SUPERIORITY_OR_OTHER|||||||0.0779||95.0|||||Fisher Exact|||||||0.0779
91756584|NCT00082407|183405374|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
91756585|NCT00082407|183405375|SUPERIORITY_OR_OTHER|||||||0.6456||95.0|||||ANCOVA|||||||0.6456
91756586|NCT00082407|183405377|SUPERIORITY_OR_OTHER|||||||0.7888||95.0|||||Fisher Exact|||||||0.7888
91756587|NCT00082407|183405378|SUPERIORITY_OR_OTHER|||||||0.3722||95.0|||||ANCOVA|||||||0.3722
91756588|NCT03464019|183405379|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.1212|TWO_SIDED|95.0|0.726|1.623|||Peto-Peto test|||In Part 1, participants who converted following medical assistance were censored at the time of conversion after medical assistance. Participants who presented missing data from time t to the end were censored at the time of last available data. Participants who did not convert or were not censored before 5 hours were censored at 5 hours.||1.623|0.726|0.1212
91756589|NCT03464019|183405379|SUPERIORITY||Hazard Ratio (HR)|2.857|||<|0.001|TWO_SIDED|95.0|1.868|4.371||The threshold for statistical significance was p \< 0.05.|Wilcoxon|||In Parts 2 and 3, participants converting after additional medication interventions were censored after the end of the observation period.||4.371|1.868|<0.001
91756590|NCT00767806|183405380|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.||||0.001
91756591|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.002|TWO_SIDED|95.0|-1.12|-0.25||P-value is for BPI severity of worst pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.||-0.25|-1.12|0.002
91756592|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.006|TWO_SIDED|95.0|-0.85|-0.14||P-value is for BPI severity of least pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.||-0.14|-0.85|0.006
91756593|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-1.25|-0.46||P-value is for BPI severity of pain right now - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.||-0.46|-1.25|<0.001
91756594|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.16|-0.35||P-value is for BPI interference with general activity - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.||-0.35|-1.16|<0.001
91756595|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.09|-0.34||P-value is for BPI interference with mood score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.||-0.34|-1.09|<0.001
91756596|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.02|TWO_SIDED|95.0|-0.84|-0.07||P-value is for BPI interference with walking ability - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.||-0.07|-0.84|0.020
91756597|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.012|TWO_SIDED|95.0|-0.9|-0.11||P-value is for BPI interference with normal work - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.||-0.11|-0.90|0.012
91756598|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.001|TWO_SIDED|95.0|-0.92|-0.22||P-value is for BPI interference with relations to others - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.||-0.22|-0.92|0.001
91756599|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.002|TWO_SIDED|95.0|-1.13|-0.27||P-value is for BPI interference with sleep score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.||-0.27|-1.13|0.002
91756600|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.005|TWO_SIDED|95.0|-0.96|-0.18||P-value is for BPI interference with enjoyment of life score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.||-0.18|-0.96|0.005
91756601|NCT00767806|183405381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.92|-0.25||P-value is for BPI average interference score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.||-0.25|-0.92|<0.001
91756602|NCT00767806|183405382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.05|-0.35||p-value is for weekly 24-hour average pain rating score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.||-0.35|-1.05|<0.001
91756603|NCT00767806|183405382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||p-value is for weekly 24-hour worst pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.||-0.33|-1.08|<0.001
91756604|NCT00767806|183405382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.004|TWO_SIDED|95.0|-0.87|-0.17||p-value is for weekly 24-hour night pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.||-0.17|-0.87|0.004
91756605|NCT00767806|183405383|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||p-value is for number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.108
91756606|NCT00767806|183405384|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.006
91756607|NCT00767806|183405385|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is difference between duloxetine and placebo in number of patients who achieve criteria described in null hypothesis|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a \>=20% reduction of BPI average pain rating from baseline at every visit.||||0.082
91756608|NCT00767806|183405386|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo groups in the empirical overall cumulated distribution of the percentage pain reduction|Kolnogorov-Smirnov test|||Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.||||0.013
91756609|NCT00767806|183405387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.077|TWO_SIDED|95.0|-0.33|0.02||p-value is for difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.||0.02|-0.33|0.077
91756610|NCT00767806|183405388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.011|TWO_SIDED|95.0|-0.56|-0.07||p-value is for difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value|ANCOVA|Main Effect Model: PGI-I=Treatment+Investigator+Baseline(Type III sums of squares). PGI-Severity score from baseline visit was used as the baseline.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.||-0.07|-0.56|0.011
91511136|NCT04116229|182894029|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.18|||>|0.46|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.46
91511137|NCT04116229|182894029|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.22|||>|0.5|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.5
91511138|NCT04116229|182894030|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.15||||0.62|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.62
91511139|NCT04116229|182894030|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.07||||0.82|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.82
91511140|NCT04116229|182894031|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
91511141|NCT04116229|182894031|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
91533940|NCT00665561|182945250|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.61|0.99||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||0.99|0.61|
91533941|NCT00665561|182945251|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.33||||||All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.33|0.64|
91756611|NCT00767806|183405389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.255|TWO_SIDED|95.0|-1.28|0.34||p-value is for difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.||0.34|-1.28|0.255
91756612|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.||-0.37|-1.38|<0.001
91756613|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.133|TWO_SIDED|95.0|-0.9|0.12||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.||0.12|-0.90|0.133
91756614|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.46|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.||-0.37|-1.46|<0.001
91756615|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||0.003|TWO_SIDED|95.0|0.38|1.88||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.||1.88|0.38|0.003
91756616|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.469|TWO_SIDED|95.0|-0.93|0.43||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.||0.43|-0.93|0.469
91756617|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.006|TWO_SIDED|95.0|-0.98|-0.17||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.||-0.17|-0.98|0.006
91756618|NCT00767806|183405390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.41|-1.6||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.||-1.60|-6.41|0.001
91756619|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.168|TWO_SIDED|95.0|-0.53|3.02||p-value is for difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.||3.02|-0.53|0.168
91756620|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.01|TWO_SIDED|95.0|0.53|3.96||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.||3.96|0.53|0.010
91756621|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.58||||0.016|TWO_SIDED|95.0|0.86|8.3||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.||8.30|0.86|0.016
91511142|NCT04116229|182894032|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
91511143|NCT04116229|182894032|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.21||||0.5|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.5
91511144|NCT04116229|182894033|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.5||||0.09|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.09
91533942|NCT00665561|182945251|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.32|1.52||||||AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.32|
91533943|NCT00665561|182945251|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.66|
91756622|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.88|||<|0.001|TWO_SIDED|95.0|2.15|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.||7.61|2.15|<0.001
91756623|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.58||||0.101|TWO_SIDED|95.0|-0.5|5.67||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.||5.67|-0.50|0.101
91756624|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.058|TWO_SIDED|95.0|-0.12|7.12||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.||7.12|-0.12|0.058
91756625|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43||||0.227|TWO_SIDED|95.0|-1.52|6.37||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.||6.37|-1.52|0.227
91756626|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.383|TWO_SIDED|95.0|-2.39|6.21||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.||6.21|-2.39|0.383
91756627|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.03|TWO_SIDED|95.0|0.38|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.||7.61|0.38|0.030
91756628|NCT00767806|183405391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.022|TWO_SIDED|95.0|0.59|7.6||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.||7.60|0.59|0.022
91756629|NCT00767806|183405392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.12||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.||0.12|0.03|<0.001
91759882|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-3.09|10.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.70|-3.09|
91756630|NCT00767806|183405392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.002|TWO_SIDED|95.0|0.02|0.08||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.||0.08|0.02|0.002
91756631|NCT00767806|183405393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.461|TWO_SIDED|95.0|-0.03|0.06||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.||0.06|-0.03|0.461
91756632|NCT00767806|183405393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.374|TWO_SIDED|95.0|-0.09|0.03||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.||0.03|-0.09|0.374
91756633|NCT00767806|183405393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.557|TWO_SIDED|95.0|-0.09|0.05||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.||0.05|-0.09|0.557
91756634|NCT00767806|183405393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.007|TWO_SIDED|95.0|-0.1|-0.02||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.||-0.02|-0.10|0.007
91756635|NCT00767806|183405395|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for difference between placebo and duloxetine groups in uric acid - change|ANOVA|Change Variable = Treatment + Investigator (Type III sums of squares). Rank-transformed change was used as change variable in the ANOVA model.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.||||0.010
91756636|NCT00767806|183405396|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value is for difference between duloxetine and placebo in albumin - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.||||0.031
91756637|NCT00767806|183405397|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo in alkaline phosphatase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.||||0.004
91756638|NCT00767806|183405398|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo in alanine aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.||||0.013
91756639|NCT00767806|183405399|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||p-value for difference between duloxetine and placebo in aspartate aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.||||0.039
91756640|NCT00767806|183405400|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for difference between duloxetine and placebo in creatinine - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.||||0.024
91756641|NCT00767806|183405401|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for difference between duloxetine and placebo in total protein - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.||||0.019
91756642|NCT00767806|183405402|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||p-value is for difference between placebo and duloxetine groups in change of systolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.||||0.329
91756643|NCT00767806|183405402|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||p-value is for difference between placebo and duloxetine groups in change of diastolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.||||0.562
91756644|NCT00767806|183405404|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||p-value is for difference between duloxetine and placebo in pulse rate - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.||||0.680
91756645|NCT00858208|183405409|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||paired t-test|||||||0.0072
91756646|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED||||||paired t-test|||Change from baseline at Week 6||||0.0433
91756647|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED||||||paired t-test|||Change from baseline at Week 12||||0.0133
91756648|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 18||||0.0278
91756649|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||paired t-test|||Change from baseline at Week 24||||0.0160
91756650|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||paired t-test|||Change from baseline at Week 30||||0.0264
91756651|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 36||||0.0278
91756652|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.1854|TWO_SIDED||||||paired t-test|||Change from baseline at Week 42||||0.1854
91756653|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.1684|TWO_SIDED||||||paired t-test|||Change from baseline at Week 48||||0.1684
91756654|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.4718|TWO_SIDED||||||paired t-test|||Change from baseline at Week 54||||0.4718
91756655|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||paired t-test|||Change from baseline at Week 60||||0.4340
91756656|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.7765|TWO_SIDED||||||paired t-test|||Change from baseline at Week 66||||0.7765
91756657|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.7544|TWO_SIDED||||||paired t-test|||Change from baseline at Week 72||||0.7544
91756658|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.7201|TWO_SIDED||||||paired t-test|||Change from baseline at Week 84||||0.7201
91756659|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.5692|TWO_SIDED||||||paired t-test|||Change from baseline at Week 90||||0.5692
91533944|NCT00665561|182945252|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.10|0.35|
91756660|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 96||||0.2749
91533945|NCT00665561|182945253|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.59|
91533946|NCT00665561|182945254|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.66|1.28||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.28|0.66|
91756661|NCT00858208|183405410|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 102||||0.2749
91756662|NCT00858208|183405412|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED||||||paired t-test|||Change at Month 6||||0.2970
91756663|NCT00858208|183405412|SUPERIORITY_OR_OTHER|||||||0.1392|TWO_SIDED||||||paired t-test|||Change at Month 12||||0.1392
91756664|NCT00858208|183405412|SUPERIORITY_OR_OTHER|||||||0.0573|TWO_SIDED||||||paired t-test|||Change at Month 18||||0.0573
91756665|NCT00858208|183405412|SUPERIORITY_OR_OTHER|||||||0.7625|TWO_SIDED||||||paired t-test|||Change at Month 24||||0.7625
91756666|NCT00858208|183405413|SUPERIORITY_OR_OTHER|||||||0.2759|TWO_SIDED||||||paired t-test|||||||0.2759
91756667|NCT01272635|183405423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.98|||Discrete time survival analysis||Hazard ratio: Numerator is Azithromycin and Denominator is Placebo|||0.98|0.41|0.04
91756668|NCT01543776|183405429|NON_INFERIORITY|The above criteria for non-inferiority corresponds to a response rate in the low dose arm that is no more than 15% lower than the response rate in the high dose arm (i.e., non-inferiority margin of 15%), under the assumption that the log ratios are approximately normally distributed.|Mean Difference (Final Values)|0.3976|||<|0.1|ONE_SIDED|90.0|-0.1111|||Calculated p-value.|t-test, 1 sided||||||-0.1111|<0.10
91756669|NCT01543776|183405430|SUPERIORITY|||||||0.38|||||||Log Rank|||||||0.38
91756670|NCT01543776|183405431|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91756671|NCT01543776|183405432|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
91756672|NCT01543776|183405433|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
91756673|NCT02870101|183405458|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|94.7|||||TWO_SIDED|95.0|90.7|97.0|||||PPA estimated with two-sided 95% score confidence interval.|||97.0|90.7|
91756674|NCT02870101|183405458|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
91756675|NCT02870101|183405459|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|91.2|||||TWO_SIDED|95.0|86.5|94.4|||||PPA estimated with two-sided 95% score confidence interval.|||94.4|86.5|
91756676|NCT02870101|183405459|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.3|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.3|
91756677|NCT02870101|183405460|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|95.1|||||TWO_SIDED|95.0|91.3|97.3|||||PPA estimated with two-sided 95% score confidence interval.|||97.3|91.3|
91756678|NCT02870101|183405460|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.3|99.2|||||NPA estimated with two-sided 95% score confidence interval.|||99.2|98.3|
91756679|NCT02870101|183405461|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|96.5|||||TWO_SIDED|95.0|92.9|98.3|||||PPA estimated with two-sided 95% score confidence interval.|||98.3|92.9|
91533947|NCT00665561|182945255|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6225|TWO_SIDED|95.0|0.66|1.28|||Regression, Cox|||||1.28|0.66|0.6225
91533948|NCT04949399|182945257|SUPERIORITY||Difference (%)|30.4|||<|0.0001|TWO_SIDED|95.0|23.5|37.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.2|23.5|<.0001
91756680|NCT02870101|183405461|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.2|||||TWO_SIDED|95.0|98.8|99.5|||||NPA estimated with two-sided 95% score confidence interval.|||99.5|98.8|
91756681|NCT02870101|183405462|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|84.8|||||TWO_SIDED|95.0|79.4|89.0|||||PPA estimated with two-sided 95% score confidence interval.|||89.0|79.4|
91756682|NCT02870101|183405462|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.5|||||TWO_SIDED|95.0|99.2|99.7|||||NPA estimated with two-sided 95% score confidence interval.|||99.7|99.2|
91756683|NCT02870101|183405463|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|88.3|||||TWO_SIDED|95.0|83.2|92.0|||||PPA estimated with two-sided 95% score confidence interval.|||92.0|83.2|
91533949|NCT04949399|182945258|SUPERIORITY||Difference (%)|39.8|||<|0.0001|TWO_SIDED|95.0|32.0|47.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.7|32.0|<0.0001
91756684|NCT02870101|183405463|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.2|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.2|
91756685|NCT02870101|183405464|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|95.9|||||TWO_SIDED|95.0|86.3|98.9|||||PPA estimated with two-sided 95% score confidence interval.|||98.9|86.3|
91756686|NCT02870101|183405464|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
91756687|NCT02870101|183405465|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|86.0|||||TWO_SIDED|95.0|80.9|89.9|||||PPA estimated with two-sided 95% score confidence interval.|||89.9|80.9|
91756688|NCT02870101|183405465|OTHER|Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.3|||||TWO_SIDED|95.0|98.9|99.6|||||NPA estimated with two-sided 95% score confidence interval.|||99.6|98.9|
91756689|NCT02870101|183405466|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.2|||||TWO_SIDED|95.0|76.6|94.5|||||PPA estimated with two-sided 95% score confidence interval.|||94.5|76.6|
91756690|NCT02870101|183405466|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
91756691|NCT02870101|183405467|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.7|||||TWO_SIDED|95.0|83.9|92.3|||||PPA estimated with two-sided 95% score confidence interval.|||92.3|83.9|
91756692|NCT02870101|183405467|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.7|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
91756693|NCT02870101|183405468|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|84.0|||||TWO_SIDED|95.0|71.5|91.7|||||PPA estimated with two-sided 95% score confidence interval.|||91.7|71.5|
91756694|NCT02870101|183405468|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.8|||||TWO_SIDED|95.0|99.5|99.9|||||NPA estimated with two-sided 95% score confidence interval.|||99.9|99.5|
91756695|NCT02870101|183405469|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|83.0|||||TWO_SIDED|95.0|77.6|87.3|||||PPA estimated with two-sided 95% score confidence interval.|||87.3|77.6|
91756696|NCT02870101|183405469|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.1|||||TWO_SIDED|95.0|98.6|99.4|||||NPA estimated with two-sided 95% score confidence interval.|||99.4|98.6|
91756697|NCT00126776|183405475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mean cumulative frequency|||primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P\<0.001)||||< 0.001
91756698|NCT02893917|183405480|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0359|TWO_SIDED|95.0|0.392|0.969|||Regression, Cox|||||0.969|0.392|0.0359
91756699|NCT02893917|183405481|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.705|2.399||no p value provided|Regression, Cox|||||2.399|0.705|
91513558|NCT03029208|182898973|SUPERIORITY||LS mean difference|0.03||||0.3154|TWO_SIDED|95.0|-0.09|0.14|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.14|-0.09|0.3154
91756700|NCT02893917|183405484|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.272|1.504|||Regression, Cox|||HRD positive ONLY||1.504|0.272|
91756701|NCT02893917|183405484|OTHER||Hazard Ratio (HR)|0.777|||||TWO_SIDED|95.0|0.448|1.348|||Regression, Cox|||HRD negative ONLY||1.348|0.448|
91511145|NCT04116229|182894033|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.45|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.45
91511146|NCT04116229|182894034|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.38||||0.19|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.19
91533950|NCT04949399|182945259|SUPERIORITY||Difference (%)|41.6|||<|0.0001|TWO_SIDED|95.0|33.7|49.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.6|33.7|<0.0001
91533951|NCT04949399|182945262|SUPERIORITY||Difference (%)|54.8|||<|0.0001|TWO_SIDED|95.0|46.8|62.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||62.8|46.8|<.0001
91756702|NCT01815840|183405509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-22.2|5.7|||||Asymptotic confidence intervals are presented for the difference between treatment arms.|The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.||5.7|-22.2|
91756703|NCT00434642|183405521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.388|0.605||A P-value \< 0.05 was required for significance.|Log Rank|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.||0.605|0.388|<0.0001
91756704|NCT00434642|183405522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.1|||<|0.0001|TWO_SIDED|95.0|13.0|29.2||A P-value \< 0.05 was required for significance.|Cochran-Mantel-Haenszel|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.|The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.||29.2|13.0|<0.0001
91756705|NCT00434642|183405524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.6479|TWO_SIDED|95.0|0.771|1.176||Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.|Log Rank|The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|||1.176|0.771|0.6479
91756706|NCT02868229|183405609|SUPERIORITY||Differences of LS Means|-5.666||||0.002|TWO_SIDED|95.0|-9.082|-2.25|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-2.250|-9.082|0.002
91756707|NCT02868229|183405609|SUPERIORITY||Differences of LS Means|-6.913|||<|0.001|TWO_SIDED|95.0|-10.613|-3.214|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-3.214|-10.613|<0.001
91756708|NCT02868229|183405609|SUPERIORITY||Differences of LS Means|-9.591|||<|0.001|TWO_SIDED|95.0|-13.217|-5.965|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-5.965|-13.217|<0.001
91533952|NCT04949399|182945263|SUPERIORITY||Difference (%)|39.1|||<|0.0001|TWO_SIDED|95.0|30.5|47.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.8|30.5|<.0001
91533953|NCT04949399|182945264|SUPERIORITY||Difference (%)|44.6|||<|0.0001|TWO_SIDED|95.0|36.8|52.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||52.5|36.8|<.0001
91756709|NCT06225466|183405784|SUPERIORITY||least squares mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.123|TWO_SIDED|95.0|-0.005|0.047|||ANOVA|||||0.047|-0.005|0.123
91756710|NCT06225466|183405785|SUPERIORITY||Odds Ratio (OR)|0.55||||0.102|TWO_SIDED|95.0|0.26|1.12|||Mixed Models Analysis|||||1.12|0.26|0.102
91756711|NCT06225466|183405786|SUPERIORITY||Incidence rate ratio|2.37||||0.008|TWO_SIDED|95.0|1.25|4.52|||Negative Binomial Regression|||||4.52|1.25|0.008
91756712|NCT03445559|183405787|SUPERIORITY||Odds Ratio (OR)|0.54||||0.006|TWO_SIDED|95.0|0.3|0.98|||Chi-squared|||||0.98|0.30|0.006
91756713|NCT03445559|183405788|SUPERIORITY||Odds Ratio (OR)|1.36||||0.42|TWO_SIDED|95.0|0.7|2.66|||Chi-squared|||||2.66|0.70|0.42
91756714|NCT03445559|183405789|SUPERIORITY||Median Difference (Final Values)|2.7|||||TWO_SIDED|||||||||||||
91756715|NCT04676867|183405805|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
91756716|NCT04676867|183405806|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
91756717|NCT04676867|183405807|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
91756718|NCT04676867|183405808|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
91756719|NCT04676867|183405809|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
91756720|NCT04676867|183405810|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
91756721|NCT04676867|183405811|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
91756722|NCT04676867|183405812|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
91756723|NCT04676867|183405813|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
91756724|NCT04676867|183405814|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
91756725|NCT04676867|183405815|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
91756726|NCT04676867|183405817|SUPERIORITY|||||||0.2|||||||ANOVA|||||||0.2
91756727|NCT04676867|183405818|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
91756728|NCT02411929|183405822|SUPERIORITY_OR_OTHER||Test (oral)/Reference (IV) of means|104.73|||||TWO_SIDED|90.0|101.64|107.91|||||Natural log transformed AUCinf(dn) and AUClast(dn) from Period 1 were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences were exponentiated.|Ratio - Test (oral) / Reference (IV) of means||107.91|101.64|
91756729|NCT02411929|183405832|SUPERIORITY_OR_OTHER||Ratio|110.71|||||||||||||The ratio (Test/Reference) of the geometric means of dose normalized natural log transformed Total 14\^C in Urine will be estimated. Total 14\^C\_Urine\_IV is the Reference formulation and Total 14C\_Urine\_Oral is the Test formulation (expressed as a %).|Ratio - Test (Oral) / Reference (IV) (%)||||
91756730|NCT04268173|183405838|EQUIVALENCE|A two sample t-test was conducted to test the null hypothesis that the pre-intervention mean response was equivalent to the post-intervention mean response in the Prevention Navigation group. Hypothesis: A p-value greater than 0.05 suggests the means are not statistically different from one another.||||||0.84|||||||t-test, 2 sided|||||||0.84
91756731|NCT02437084|183405857|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|SSPG concentration was log-transformed for statistical analysis; degrees of freedom = 69||Null hypothesis: There will be no change in steady-state plasma glucose (SSPG) concentration after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||0.01
91756732|NCT02437084|183405858|OTHER||||||<|0.001|||||||Paired samples t test, 2 sided|Insulin secretion rate AUC was log-transformed for statistical analysis; degrees of freedom = 63.||Null hypothesis: There will be no change in insulin secretion rate AUC after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||<0.001
91756733|NCT02437084|183405859|OTHER|||||||0.1|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in fasting plasma glucose concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.10
91756734|NCT02437084|183405860|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|Fasting plasma insulin concentration was log-transformed for statistical analysis; degrees of freedom = 68||Null hypothesis: There will be no change in fasting plasma insulin concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.01
91756735|NCT02437084|183405861|OTHER|||||||0.03|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in OGTT glucose AUC after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.03
91756736|NCT02437084|183405862|OTHER|||||||0.27|||||||Paired samples t test, 2 sided|OGTT insulin AUC was log-transformed for statistical analysis; degrees of freedom = 63||Null hypothesis: There will be no change in OGTT insulin AUC after treatment with atorvastatin 40 mg daily for 8 weeks.||||0.27
91756737|NCT02228096|183405925|OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
91756738|NCT02925728|183405965|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91756739|NCT02102399|183405967|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.001
91756740|NCT02102399|183405968|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.345
91756741|NCT02102399|183405969|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
91756742|NCT02102399|183405970|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.171
91756743|NCT02102399|183405971|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.022
91756744|NCT02102399|183405972|SUPERIORITY_OR_OTHER|||||||0.451|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.451
91756745|NCT02102399|183405973|SUPERIORITY_OR_OTHER|||||||0.477|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.477
91756746|NCT02102399|183405974|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.007
91756747|NCT02102399|183405975|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.049
91756748|NCT02102399|183405976|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.323
91756749|NCT02102399|183405977|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.296
91756750|NCT02102399|183405978|SUPERIORITY_OR_OTHER|||||||0.776|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.776
91756751|NCT02102399|183405979|SUPERIORITY_OR_OTHER|||||||0.959|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.959
91756752|NCT02102399|183405980|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.76
91756753|NCT02102399|183405981|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
91511147|NCT04116229|182894034|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.52|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.52
91511148|NCT04116229|182894035|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.05||||0.9|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.90
91756754|NCT02102399|183405982|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
91756755|NCT02102399|183405983|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.77
91756756|NCT02102399|183405984|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.49
91756757|NCT02102399|183405985|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.74
91756758|NCT02102399|183405986|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Fisher Exact|||||||0.120
91756759|NCT02102399|183405987|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.030
91756760|NCT02102399|183405988|SUPERIORITY_OR_OTHER|||||||0.107|TWO_SIDED||||||Fisher Exact|||||||0.107
91756761|NCT00086411|183406009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.2734|<|0.017|TWO_SIDED|95.0|0.77|2.25||The p-value was adjusted for multiple comparisons.|GEE model for repeated binary outcomes|Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race|The above was for the main effect of BUP versus NTX on cessation.|Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.||2.25|0.77|<0.017
91756762|NCT02530996|183406012|OTHER|Power calculations were performed using G\*Power computer software version 3. Sample-size calculations were based on the number of patients needed to detect significant differences in FMD between placebo and BH4.|Mean Difference (Net)|1.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Statistics were performed using SPSS software (IBM, Chicago, IL). Paired t-tests were used to identify significant changes in measured variables between placebo and BH4. Unpaired t-tests were used to identify significant changes in measured variables between ordered groups. Based on data published in PMID: 25511849 power calculations for this study of SSc patients were made.||||<0.05
91756763|NCT04484207|183406028|SUPERIORITY|||||||0.031|||||||GEE|||||||0.031
91756764|NCT00752726|183406032|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.263|STANDARD_ERROR_OF_MEAN|0.115||0.0244|TWO_SIDED|95.0|0.035|0.491||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.491|0.035|0.0244
91756765|NCT00752726|183406033|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.172|STANDARD_ERROR_OF_MEAN|0.0834||0.0415|TWO_SIDED|95.0|0.007|0.337||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.||0.337|0.007|0.0415
91756766|NCT00752726|183406034|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.881||0.026|TWO_SIDED|95.0|0.25|3.74||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.74|0.25|0.026
91756767|NCT00752726|183406035|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.642|STANDARD_ERROR_OF_MEAN|0.7174||0.0242|TWO_SIDED|95.0|0.219|3.065||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.065|0.219|0.0242
91756768|NCT00752726|183406036|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.704||0.039|TWO_SIDED|95.0|0.07|2.87||P-value was not adjusted for multiple comparisons|ANCOVA|Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2.87|0.07|0.039
91756769|NCT00752726|183406037|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.974||0.085|TWO_SIDED|95.0|-0.24|3.63||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.63|-0.24|0.085
91533954|NCT04949399|182945265|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-6.7|-4.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.7|-6.7|<.0001
91756770|NCT00752726|183406039|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.0232||0.3235|TWO_SIDED|95.0|-0.069|0.023||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.023|-0.069|0.3235
91756771|NCT00752726|183406040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|783.8|STANDARD_ERROR_OF_MEAN|726.54||0.28|TWO_SIDED|95.0|-657.3|2224.9||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2224.9|-657.3|0.28
91511149|NCT04116229|182894035|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.04||||0.87|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.87
91511150|NCT04116229|182894036|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.34||||0.26|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.26
91511151|NCT04116229|182894036|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
91511152|NCT04116229|182894037|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.54|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.54
91511153|NCT04116229|182894037|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.09||||0.77|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.77
91511154|NCT02595684|182894038|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
91511155|NCT02595684|182894038|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||||||0.635
91511156|NCT02595684|182894039|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.380
91511157|NCT02595684|182894039|SUPERIORITY|||||||0.441|||||||Wilcoxon (Mann-Whitney)|||||||0.441
91511158|NCT02595684|182894040|SUPERIORITY|||||||515|||||||Wilcoxon (Mann-Whitney)|||||||0515
91511159|NCT02595684|182894040|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
91511160|NCT02595684|182894041|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
91511161|NCT02595684|182894041|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
91511162|NCT02595684|182894042|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
91756772|NCT00752726|183406041|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.542||0.2847|TWO_SIDED|95.0|-1.4|4.72||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.|Adjusted mean difference was calculated as placebo minus orlistat.|The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.||4.72|-1.40|0.2847
91511163|NCT02595684|182894042|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
91511164|NCT02595684|182894043|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
91511165|NCT02595684|182894043|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
91511166|NCT02595684|182894044|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
91511167|NCT02595684|182894044|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
91511168|NCT02595684|182894045|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
91511169|NCT02595684|182894045|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
91511170|NCT02595684|182894046|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
91511171|NCT02595684|182894046|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||||||0.086
91511172|NCT02595684|182894047|SUPERIORITY|||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
91511173|NCT02595684|182894047|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
91511174|NCT02595684|182894048|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
91511175|NCT02595684|182894048|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
91511176|NCT02595684|182894049|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
91511177|NCT02595684|182894049|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
91511178|NCT02595684|182894050|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||||||0.722
91511179|NCT02595684|182894050|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
91756773|NCT04232215|183406055|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.64|TWO_SIDED|95.0|-10.2|6.1|||Regression, Linear|A generalized linear model adjusting by intervention group and the order of randomization was conducted.||Difference in ease of use between our standard fetal Doppler and HeraBEAT™ device, as measured by the System Usability Survey (SUS) will be the primary outcome. We aim to recruit 50 participants (50 per arm, with cross-over) for a 99.7% power to detect a 10-point difference in SUS, as this accounts for a withdraw / post-randomization exclusion as high as 10% (assuming a proportion of expectant mothers to withdraw participation after being enrolled or found to not meet criteria after the fact).||6.1|-10.2|0.64
91756774|NCT04232215|183406056|SUPERIORITY||Risk Ratio (RR)|1.2||||0.63|TWO_SIDED|95.0|0.57|2.53|||Chi-squared|||||2.53|0.57|0.63
91756775|NCT01555125|183406057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91756776|NCT01555125|183406057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91756777|NCT01555125|183406058|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91756778|NCT01555125|183406058|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91756779|NCT04836247|183406080|SUPERIORITY||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
91756780|NCT04836247|183406081|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
91756781|NCT04836247|183406082|SUPERIORITY||Mean Difference (Final Values)|2.61|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
91756782|NCT04836247|183406083|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
91756783|NCT04836247|183406084|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
91756784|NCT04836247|183406085|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
91756785|NCT04268745|183406086|SUPERIORITY||Mean Difference (Final Values)|-13.603||||0.027|TWO_SIDED|95.0|-25.634|-1.573|||Regression, Linear|||||-1.573|-25.634|0.027
91756786|NCT04268745|183406087|SUPERIORITY||Median Difference (Final Values)|6.405||||0.0001|TWO_SIDED|95.0|4.474|8.335|||Regression, Linear|||||8.335|4.474|0.0001
91756787|NCT04268745|183406088|SUPERIORITY||Mean Difference (Final Values)|-18.703||||0.0002|TWO_SIDED|95.0|-28.235|-9.172|||Regression, Linear|||||-9.172|-28.235|0.0002
91756788|NCT04268745|183406089|SUPERIORITY||Mean Difference (Final Values)|8.556||||0.028|TWO_SIDED|95.0|0.938|16.174|||Regression, Linear|||||16.174|0.938|0.028
91756789|NCT04268745|183406090|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.695|TWO_SIDED|95.0|-0.443|0.665|||Regression, Linear|||||0.665|-0.443|0.695
91756790|NCT04268745|183406091|SUPERIORITY||Mean Difference (Final Values)|-0.514||||0.469|TWO_SIDED|95.0|-1.901|0.874|||Regression, Linear|||||0.874|-1.901|0.469
91756791|NCT00896441|183406101|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|One sample t-test||||||<0.01
91756792|NCT00896441|183406103|OTHER||||||<|0.006|||||||t-test, 2 sided|Single group t-test||||||<.006
91756793|NCT01078168|183406114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3769||||0.0347|TWO_SIDED|95.0|0.03025|0.7235||threshold: p\<0.05|t-test, 2 sided|||||0.7235|0.03025|0.0347
91756794|NCT02467582|183406138|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
91756795|NCT02467582|183406138|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.27|1.22|||||Unstratified|||1.22|0.27|
91756796|NCT02467582|183406138|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.22|1.46|||||Stratified|||1.46|0.22|
91756797|NCT02467582|183406139|SUPERIORITY|||||||0.089|||||||Log Rank|||||||0.089
91756798|NCT02467582|183406139|SUPERIORITY||Hazard Ratio (HR)|0.49|||||TWO_SIDED|90.0|0.21|1.19|||||Unstratified|||1.19|0.21|
91756799|NCT02467582|183406139|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|90.0|0.2|1.55|||||Stratified|||1.55|0.20|
91756800|NCT02467582|183406140|SUPERIORITY|||||||0.3|||||||Log Rank|||||||0.3
91756801|NCT02467582|183406140|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|90.0|0.23|2.13|||||Unstratified|||2.13|0.23|
91756802|NCT02467582|183406140|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.15|2.43|||||Stratified|||2.43|0.15|
91756803|NCT01593592|183406163|SUPERIORITY_OR_OTHER||percentage|0.0|||||TWO_SIDED|95.0||||||||A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).||||
91756804|NCT02397057|183406169|OTHER|Observed cases, logistic regression analysis. Subjects with missing data on Day 42 were excluded from the statistical testing.|Odds Ratio (OR)|1.35||||0.369|TWO_SIDED|95.0|0.7|2.63||p-value was estimated by logistic regression with treatment, region (US, EUR), and baseline RLS medication-related augmentation as fixed factors, and baseline IRLS as a covariate.|Regression, Logistic|||||2.63|0.70|0.3690
91756805|NCT02397057|183406173|OTHER||Least square(LS) mean difference|-4.071|STANDARD_ERROR_OF_MEAN|2.542||0.1108|TWO_SIDED|95.0|-9.083|0.941|||ANCOVA|||LOCF, ANCOVA Analysis||0.941|-9.083|0.1108
91511180|NCT02595684|182894051|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
91511181|NCT02595684|182894051|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
91756806|NCT02397057|183406174|OTHER|||||||0.0002||||||p-value was estimated using continuity-corrected chi-square test.|Chi-squared, Corrected|||||||0.0002
91756807|NCT03927144|183406188|SUPERIORITY||Odds Ratio (OR)|6.48|||<|0.0001|TWO_SIDED|95.0|4.28|9.82|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (no. of prior prophylactic migraine treatment failures=1 vs 2) after missing data were imputed as non-response.||||9.82|4.28|<0.0001
91756808|NCT03927144|183406189|SUPERIORITY||Odds Ratio (OR)|11.27|||<|0.0001|TWO_SIDED|95.0|7.53|16.87|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||16.87|7.53|<0.0001
91756809|NCT03927144|183406190|SUPERIORITY||Treatment difference|-2.13|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.74|-1.52|||Linear mixed effects model||AMG334 70 mg/140 mg vs Oral Prophylactic|Comparison of mean change from baseline in monthly migraine days at Week 52||-1.52|-2.74|<0.001
91756810|NCT03927144|183406191|SUPERIORITY||Odds Ratio (OR)|13.75|||<|0.001|TWO_SIDED|95.0|9.08|20.83|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||20.83|9.08|<0.001
91511182|NCT02595684|182894052|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
91756811|NCT03002311|183406236|SUPERIORITY|We conducted a conditional power analysis 120 days after 6 months of enrollment. We determined the effect size based on the difference of proportions of follow-up attendance in the intervention and control arms. We used the effect size of 20% to estimate the sample size needed for a two-sided alpha of 0.05 at 90% power and a 1:1 ratio to require 266 participants. Loss to follow-up was estimated to be 20%, increasing target enrollment to 334 total participants.|||||<|0.001|||||||Gray's test|We compared the cumulative incidence function.||||||<0.001
91511183|NCT02595684|182894052|SUPERIORITY|||||||0.952|||||||Wilcoxon (Mann-Whitney)|||||||0.952
91511184|NCT02595684|182894053|SUPERIORITY|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
91511185|NCT02595684|182894053|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
91511186|NCT02595684|182894054|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
91511187|NCT02595684|182894054|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
91511188|NCT02809976|182894055|OTHER|single group/descriptive analysis||||||0.02|||||||paired t-test|||||||0.02
91511189|NCT01513291|182894062|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.33153|TWO_SIDED|95.0|-1.3|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.3|0.33153
91511190|NCT01513291|182894063|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|-3.4|21.6|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||21.6|-3.4|
91511191|NCT01513291|182894064|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-4.0|8.9|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||8.9|-4.0|
91511192|NCT01513291|182894065|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.24008|TWO_SIDED|95.0|-1.4|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.4|0.24008
91756812|NCT03002311|183406237|SUPERIORITY|This was a secondary analysis so no power analysis was done.||||||0.8||||||We used a two-sided alpha of 0.05 to determine significance.|Gray's test|We compared the cumulative incidence functions.||||||0.8
91511193|NCT01513291|182894066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.43093|TWO_SIDED|95.0|0.7|2.0|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period 1 (≤8, \>8) as covariates.|||2.0|0.7|0.43093
91511194|NCT01513291|182894067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9737|TWO_SIDED|95.0|0.7|1.5|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Treatment Period 1 (≤8, \>8) as covariates.|||1.5|0.7|0.97370
91511195|NCT01034397|182894068|SUPERIORITY_OR_OTHER|||||||1||||||Wrist region: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
91511196|NCT01034397|182894068|SUPERIORITY_OR_OTHER|||||||0.026||||||2nd and 5th MCP joints: Tocilizumab versus placebo|t-test, 1 sided|||||||0.026
91511197|NCT01034397|182894068|SUPERIORITY_OR_OTHER|||||||1||||||Total synovitis score: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
91511198|NCT01034397|182894069|SUPERIORITY_OR_OTHER|||||||0.421||||||Percentage Change in OMERACT RAMRIS global score; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.421
91511199|NCT01034397|182894070|SUPERIORITY_OR_OTHER|||||||0.434||||||Absolute change in OMERACT RAMRIS global score; Placebo versus Tocilizumab|t-test, 1 sided|||||||0.434
91511200|NCT01034397|182894073|SUPERIORITY_OR_OTHER|||||||1||||||Change in Wrist region; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
91511201|NCT01034397|182894073|SUPERIORITY_OR_OTHER|||||||0.065||||||Change in 2nd to 5th MCP; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.065
91511202|NCT01034397|182894073|SUPERIORITY_OR_OTHER|||||||1||||||Change in Total synovitis; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
91511203|NCT01034397|182894075|SUPERIORITY_OR_OTHER|||||||1||||||Absolute Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
91511204|NCT01034397|182894076|SUPERIORITY_OR_OTHER|||||||1||||||Percentage Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
91511205|NCT01034397|182894079|SUPERIORITY_OR_OTHER|||||||0.266||||||Percentage Change in Bone oedema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.266
91511206|NCT01034397|182894080|SUPERIORITY_OR_OTHER|||||||0.337||||||Absolute Change in Bone edema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.337
91511207|NCT01034397|182894083|SUPERIORITY_OR_OTHER|||||||0.114||||||Percentage change in DCE-MRI EER (global); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.114
91511208|NCT01034397|182894084|SUPERIORITY_OR_OTHER|||||||0.239||||||Absolute Change in DCE-MRI EER; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.239
91511209|NCT01034397|182894087|SUPERIORITY_OR_OTHER|||||||0.271||||||Percentage change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.271
91511210|NCT01034397|182894088|SUPERIORITY_OR_OTHER|||||||0.37||||||Absolute change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.370
91756813|NCT04071158|183406313|SUPERIORITY||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.4|2.8||||||Difference in percentage||2.8|-1.4|
91756814|NCT04071158|183406314|SUPERIORITY||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-4.6|1.7||||||Difference in percentage||1.7|-4.6|
91756815|NCT04071158|183406315|SUPERIORITY||Ratio of Geometric Mean|0.8|||||TWO_SIDED|95.0|0.64|1.0||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||1.00|0.64|
91511211|NCT01034397|182894091|SUPERIORITY_OR_OTHER|||||||1||||||Percentage and absolute change in DCE-MRI EER (wrist); Placebo versus Tocilizumab|t-test, 1 sided|||||||1.00
91511212|NCT01034397|182894096|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91511213|NCT01034397|182894099|SUPERIORITY_OR_OTHER|||||||0.067|||||||t-test, 1 sided|||||||0.067
91511214|NCT01034397|182894101|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
91511215|NCT01034397|182894103|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
91511216|NCT01034397|182894105|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Baseline to Week 12|Friedman's T test|||||||<0.001
91511217|NCT01034397|182894105|SUPERIORITY_OR_OTHER|||||||0.5||||||Change from Baseline to Week 12|Friedman's T test|||||||0.500
91756816|NCT04071158|183406315|SUPERIORITY||Ratio of Geometric Mean|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.70|0.50|
91756817|NCT04071158|183406315|SUPERIORITY||Ratio of Geometric Mean|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.76|0.48|
91756818|NCT04071158|183406316|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% confidence interval (CI) from the ratio of titers with 50 percent cut off from two treatment groups greater than (\>) 0.5.||1.13|0.84|
91756819|NCT04071158|183406317|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.5.||1.14|0.81|
91756820|NCT04071158|183406322|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.13|0.84|
91756821|NCT04071158|183406323|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.14|0.81|
91756822|NCT01178099|183406328|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.05|||||TWO_SIDED|90.0|0.829|1.33|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.33|0.829|
91756823|NCT01178099|183406328|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.895|||||TWO_SIDED|90.0|0.718|1.12|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||1.12|0.718|
91756824|NCT01178099|183406328|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.905|||||TWO_SIDED|90.0|0.656|1.25|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD.|||1.25|0.656|
91756825|NCT01178099|183406329|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.953|||||TWO_SIDED|90.0|0.664|1.37|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.37|0.664|
91756826|NCT01178099|183406329|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.612|||||TWO_SIDED|90.0|0.436|0.86|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||0.860|0.436|
91756827|NCT01178099|183406329|SUPERIORITY_OR_OTHER||Geometric LS Means, SCD:Healthy|1.03|||||TWO_SIDED|90.0|0.625|1.68|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD.|||1.68|0.625|
91756828|NCT01178099|183406330|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.070
91756829|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.52|||||TWO_SIDED|90.0|1.1|2.1|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.10|1.10|
91511218|NCT01034397|182894106|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 1 sided|||||||0.007
91511219|NCT01034397|182894109|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
91511220|NCT01034397|182894111|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
91511221|NCT01034397|182894113|SUPERIORITY_OR_OTHER|||||||0.118|||||||t-test, 1 sided|||||||0.118
91511222|NCT01034397|182894115|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
91511223|NCT01034397|182894117|SUPERIORITY_OR_OTHER|||||||0.437|||||||t-test, 1 sided|||||||0.437
91756830|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.44|||||TWO_SIDED|90.0|1.06|1.94|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.94|1.06|
91756831|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.43|||||TWO_SIDED|90.0|0.918|2.21|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||2.21|0.918|
91756832|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.971|||||TWO_SIDED|90.0|0.742|1.27|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite.|||1.27|0.742|
91756833|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.815|||||TWO_SIDED|90.0|0.633|1.05|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD for the R-106583 metabolite.|||1.05|0.633|
91756834|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.952|||||TWO_SIDED|90.0|0.658|1.38|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD for the R-106583 metabolite.|||1.38|0.658|
91756835|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.17|||||TWO_SIDED|90.0|0.833|1.65|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.65|0.833|
91511224|NCT01034397|182894118|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
91511225|NCT01034397|182894121|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 1 sided|||||||0.190
91511226|NCT01034397|182894123|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 1 sided|||||||0.051
91511227|NCT02002767|182894125|OTHER||Geometric Least Squares Mean(GLSM) Ratio|149.05|||||TWO_SIDED|90.0|116.62|190.49||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||190.49|116.62|
91511228|NCT02002767|182894126|OTHER||GLSM Ratio|149.9|||||TWO_SIDED|90.0|116.97|192.11||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||192.11|116.97|
91511229|NCT02002767|182894127|OTHER||GLSM Ratio|110.85|||||TWO_SIDED|90.0|90.76|135.38||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||135.38|90.76|
91511230|NCT00113516|182894161|SUPERIORITY_OR_OTHER||probability|0.405|||||TWO_SIDED|90.0|0.315|0.494|||Kaplan-Meier||The probability of survival along with the corresponding confidence interval (CI) (for the log \[-log (1-year survival rate)\]) was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival rate itself.|The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.||0.494|0.315|
91511231|NCT00113516|182894165|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.4|||||TWO_SIDED|95.0|18.2|38.2||||||||38.2|18.2|
91511232|NCT00113516|182894179|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Wilcoxon Rank Sum Test|||||||0.474
91511233|NCT00113516|182894180|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.836
91511234|NCT00113516|182894180|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.071
91511235|NCT00113516|182894180|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.393
91511236|NCT00113516|182894180|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.029
91511237|NCT00113516|182894180|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.247
91511238|NCT00113516|182894181|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Wilcoxon Rank Sum Test|||||||0.305
91511239|NCT00113516|182894182|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.738
91511240|NCT00113516|182894182|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.438
91511241|NCT00113516|182894182|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.236
91511242|NCT00113516|182894182|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.287
91511243|NCT00113516|182894182|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.772
91756836|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.07|||||TWO_SIDED|90.0|0.779|1.48|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.48|0.779|
91756837|NCT01178099|183406331|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.813|||||TWO_SIDED|95.0|0.51|1.3|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.30|0.510|
91756838|NCT01178099|183406332|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.018
91756839|NCT01178099|183406333|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
91756840|NCT01178099|183406334|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.219
91511244|NCT00113516|182894183|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||Wilcoxon Rank Sum Test|||||||0.537
91511245|NCT00113516|182894184|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.813
91511246|NCT00113516|182894184|SUPERIORITY_OR_OTHER|||||||0.849||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.849
91511247|NCT00113516|182894184|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.121
91511248|NCT00113516|182894184|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.582
91511249|NCT00113516|182894184|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.383
91511250|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.6782|TWO_SIDED|95.0|0.61|2.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.15|0.61|0.6782
91511251|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.198|TWO_SIDED|95.0|0.77|3.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.30|0.77|0.1980
91756841|NCT01178099|183406335|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.177
91756842|NCT01178099|183406336|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.168
91756843|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.5|||||TWO_SIDED|90.0|1.01|2.22|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.22|1.01|
91511252|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.1344|TWO_SIDED|95.0|0.82|3.98|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.98|0.82|0.1344
91511253|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
91511254|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6||||0.0153|TWO_SIDED|95.0|1.19|11.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 1||11.13|1.19|0.0153
91756844|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.09|||||TWO_SIDED|90.0|0.751|1.58|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.58|0.751|
91511255|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 28||14.37|0.52|0.2085
91756845|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.87|||||TWO_SIDED|90.0|1.09|3.2|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||3.20|1.09|
91756846|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.873|||||TWO_SIDED|90.0|0.66|1.15|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite.|||1.15|0.660|
91756847|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.681|||||TWO_SIDED|90.0|0.524|0.886|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-106583 metabolite.|||0.886|0.524|
91756848|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.898|||||TWO_SIDED|90.0|0.612|1.32|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-106583 metabolite.|||1.32|0.612|
91756849|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.06|||||TWO_SIDED|90.0|0.773|1.46|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.46|0.773|
91756850|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.785|||||TWO_SIDED|90.0|0.582|1.06|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.06|0.582|
91756851|NCT01178099|183406337|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.0|||||TWO_SIDED|90.0|0.648|1.55|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.55|0.648|
91756852|NCT01178099|183406338|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
91756853|NCT01178099|183406339|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for PRI by flow cytometry. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.086
91511256|NCT00113516|182894185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 5, Day 28||23.57|0.08|0.8084
91756854|NCT01178099|183406339|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.679
91756855|NCT01178099|183406340|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||This is the p-value for AU\*min to 6.5 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.396
91756856|NCT01178099|183406340|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||This is the p-value for AU\*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.288
91756857|NCT01178099|183406340|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||This is the p-value for AU\*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.095
91756858|NCT01178099|183406340|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for AU\*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.086
91756859|NCT01178099|183406341|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.083
91756860|NCT01178099|183406342|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.124
91756861|NCT02473367|183406343|SUPERIORITY_OR_OTHER||Geom. least-squares mean ratio (GLSMR)|0.28|||||TWO_SIDED|90.0|0.24|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.24|
91511257|NCT00113516|182894186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.507|TWO_SIDED|95.0|0.65|2.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.39|0.65|0.5070
91756862|NCT02473367|183406343|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.73|1.03|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.03|0.73|
91756863|NCT02473367|183406343|SUPERIORITY_OR_OTHER||GLSMR|0.9|||||TWO_SIDED|90.0|0.8|1.03|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.03|0.80|
91756864|NCT02473367|183406344|SUPERIORITY_OR_OTHER||GLSMR|0.26|||||TWO_SIDED|90.0|0.21|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.21|
91511258|NCT00113516|182894186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4474|TWO_SIDED|95.0|0.63|2.82|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||2.82|0.63|0.4474
91511259|NCT00113516|182894186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7599|TWO_SIDED|95.0|0.4|1.95|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.95|0.40|0.7599
91511260|NCT00113516|182894186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
91511261|NCT00113516|182894186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6878|TWO_SIDED|95.0|0.43|3.58|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||3.58|0.43|0.6878
91511262|NCT00113516|182894186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
91756865|NCT02473367|183406344|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.65|1.15|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.15|0.65|
91511263|NCT00113516|182894187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5277|TWO_SIDED|95.0|0.39|1.62|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.62|0.39|0.5277
91756866|NCT02473367|183406344|SUPERIORITY_OR_OTHER||GLSMR|0.98|||||TWO_SIDED|90.0|0.81|1.17|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.17|0.81|
91756867|NCT02473367|183406345|SUPERIORITY_OR_OTHER||GLSMR|0.52|||||TWO_SIDED|90.0|0.45|0.61|||||Raltegravir+TUMS/Raltegravir only|||0.61|0.45|
91756868|NCT02473367|183406345|SUPERIORITY_OR_OTHER||GLSMR|0.42|||||TWO_SIDED|90.0|0.34|0.52|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||0.52|0.34|
91756869|NCT02473367|183406345|SUPERIORITY_OR_OTHER||GLSMR|0.43|||||TWO_SIDED|90.0|0.36|0.51|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||0.51|0.36|
91756870|NCT04816721|183406348|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.96||||0.1249|TWO_SIDED|95.0|-2.21|0.28|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.28|-2.21|0.1249
91756871|NCT04816721|183406348|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-1.41||||0.058|TWO_SIDED|95.0|-2.88|0.05|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.05|-2.88|0.0580
91756872|NCT04816721|183406348|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.43||||0.5877|TWO_SIDED|95.0|-2.02|1.16|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||1.16|-2.02|0.5877
91756873|NCT04816721|183406348|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.84||||0.2932|TWO_SIDED|95.0|-0.76|2.43|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||2.43|-0.76|0.2932
91756874|NCT04816721|183406349|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
91756875|NCT04816721|183406349|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.4728|TWO_SIDED|95.0|-1.23|0.58|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.58|-1.23|0.4728
91533955|NCT04949399|182945268|SUPERIORITY||Difference (%)|46.1|||<|0.0001|TWO_SIDED|96.0|38.1|54.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||54.2|38.1|<0.0001
91756876|NCT04816721|183406349|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.7||||0.2058|TWO_SIDED|95.0|-1.79|0.39|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||0.39|-1.79|0.2058
91533956|NCT04949399|182945269|SUPERIORITY||Difference (%)|51.9|||<|0.0001|TWO_SIDED|95.0|43.3|60.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||60.5|43.3|<0.0001
91533957|NCT04949399|182945270|SUPERIORITY||Difference (%)|40.1|||<|0.0001|TWO_SIDED|95.0|31.3|49.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.0|31.3|<0.0001
91756877|NCT04816721|183406349|OTHER|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.33||||0.5391|TWO_SIDED|95.0|-0.74|1.41|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||1.41|-0.74|0.5391
91756878|NCT04816721|183406351|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
91756879|NCT04816721|183406351|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.67||||0.5359|TWO_SIDED|95.0|-2.81|1.47|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 5: EDP-938 Versus Placebo||1.47|-2.81|0.5359
91756880|NCT04816721|183406351|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-2.73||||0.3029|TWO_SIDED|95.0|-7.95|2.5|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 9: EDP-938 Versus Placebo||2.50|-7.95|0.3029
91756881|NCT04816721|183406351|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-3.64||||0.3871|TWO_SIDED|95.0|-11.98|4.69|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 14: EDP-938 Versus Placebo||4.69|-11.98|0.3871
91756882|NCT00997620|183406404|OTHER||Mean Difference (Net)|0.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.||||< .05
91756883|NCT00599638|183406464|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.306||0.391|TWO_SIDED|80.0|-0.31|0.48|||Mixed Models Analysis|||||0.48|-0.31|0.3910
91756884|NCT00599638|183406464|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.357||0.0002|TWO_SIDED|80.0|-1.78|-0.86|||Mixed Models Analysis|||||-0.86|-1.78|0.0002
91756885|NCT00599638|183406465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0055||||0.4959|TWO_SIDED|80.0|0.3|1.71|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||1.71|0.30|0.4959
91756886|NCT00599638|183406465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.0763||||0.0011|TWO_SIDED|80.0|1.69|8.46|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||8.46|1.69|0.0011
91756887|NCT00599638|183406467|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|2.819||0.338|TWO_SIDED|80.0|-2.47|4.84|||Mixed Models Analysis|||||4.84|-2.47|0.3380
91756888|NCT00599638|183406467|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.65|STANDARD_ERROR_OF_MEAN|3.268||0.0022|TWO_SIDED|80.0|-13.89|-5.42|||Mixed Models Analysis|||||-5.42|-13.89|0.0022
91756889|NCT03836677|183406502|OTHER||Geometric Mean ratio to baseline|1.72|||<|0.0001|TWO_SIDED|95.0|1.38|2.13||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||2.13|1.38|<0.0001
91756890|NCT03836677|183406502|OTHER||Geometric mean ratio to baseline|1.53|||<|0.0001|TWO_SIDED|95.0|1.28|1.83||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test.||||1.83|1.28|<0.0001
91756891|NCT03836677|183406503|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.63||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.39|<0.0001
91756892|NCT03836677|183406503|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.67|0.40|<0.0001
91511264|NCT00113516|182894187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.466|TWO_SIDED|95.0|0.58|3.29|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 1, Day 28||3.29|0.58|0.4660
91511265|NCT00113516|182894187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5337|TWO_SIDED|95.0|0.52|3.44|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 1||3.44|0.52|0.5337
91511266|NCT00113516|182894187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
91511267|NCT00113516|182894187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.2948|TWO_SIDED|95.0|0.54|7.07|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 1||7.07|0.54|0.2948
91511268|NCT00113516|182894187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
91511269|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.7824|TWO_SIDED|95.0|0.56|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.56|0.7824
91511270|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1918|TWO_SIDED|95.0|0.77|3.47|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.47|0.77|0.1918
91511271|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.1093|TWO_SIDED|95.0|0.85|4.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||4.30|0.85|0.1093
91511272|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
91511273|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.2||||0.011|TWO_SIDED|95.0|1.26|13.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||13.85|1.26|0.0110
91511274|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||14.37|0.52|0.2085
91511275|NCT00113516|182894188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||23.57|0.08|0.8084
91511276|NCT00113516|182894189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5215|TWO_SIDED|95.0|0.62|2.53|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.53|0.62|0.5215
91511277|NCT00113516|182894189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2504|TWO_SIDED|95.0|0.72|3.49|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.49|0.72|0.2504
91511278|NCT00113516|182894189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8766|TWO_SIDED|95.0|0.42|2.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.11|0.42|0.8766
91756893|NCT03836677|183406504|OTHER||Geometric mean ratio to baseline|1.7|||<|0.0001||95.0|1.37|2.11|||t-test, 2 sided|Within-group comparison to baseline using paired test||||2.11|1.37|<0.0001
91756894|NCT03836677|183406504|OTHER||Geometric mean ratio to baseline|1.51||||0.0001|TWO_SIDED|95.0|1.26|1.8|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.80|1.26|0.0001
91756895|NCT03836677|183406505|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.4|0.63|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.40|<0.0001
91756896|NCT03836677|183406505|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.68|0.40|<0.0001
91756897|NCT03836677|183406506|OTHER||Mean Change from Baseline|0.346||||0.0003|TWO_SIDED|95.0|0.182|0.509|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.509|0.182|0.0003
91756898|NCT03836677|183406506|OTHER||Mean Change from Baseline|0.273||||0.0004|TWO_SIDED|95.0|0.14|0.405|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.405|0.140|0.0004
91756899|NCT03836677|183406507|OTHER||Mean ratio to baseline|-0.28||||0.2515|TWO_SIDED|95.0|-0.77|0.21|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.21|-0.77|0.2515
91756900|NCT03836677|183406507|OTHER||Mean ratio to baseline|-0.5||||0.004|TWO_SIDED|95.0|-0.81|-0.18|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||-0.18|-0.81|0.0040
91756901|NCT00462748|183406526|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
91756902|NCT00462748|183406526|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
91756903|NCT03429543|183406527|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.2935|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.30|-0.99|0.2935
91511279|NCT00113516|182894189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
91756904|NCT03429543|183406527|OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.33||0.0116|TWO_SIDED|95.0|-1.5|-0.19|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.19|-1.50|0.0116
91756905|NCT03429543|183406527|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.4||0.1943|TWO_SIDED|95.0|-1.31|0.27|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 2 (TG2) consisting of Placebo, Empagliflozin 25mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.27|-1.31|0.1943
91756906|NCT03429543|183406527|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.37||0.0015|TWO_SIDED|95.0|-1.9|-0.45|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 3 (TG3) consisting of Placebo, Empagliflozin 10mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.45|-1.90|0.0015
91756907|NCT03429543|183406528|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
91511280|NCT00113516|182894189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.5627|TWO_SIDED|95.0|0.46|4.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||4.18|0.46|0.5627
91511281|NCT00113516|182894189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
91511282|NCT00113516|182894190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.6682|TWO_SIDED|95.0|0.39|1.84|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.84|0.39|0.6682
91511283|NCT00113516|182894190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6854|TWO_SIDED|95.0|0.49|3.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.00|0.49|0.6854
91511284|NCT00113516|182894190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.6028|TWO_SIDED|95.0|0.49|3.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.37|0.49|0.6028
91511285|NCT00113516|182894190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
91511286|NCT00113516|182894190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.3411|TWO_SIDED|95.0|0.5|7.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||7.15|0.50|0.3411
91511287|NCT00113516|182894190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
91511288|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4768|TWO_SIDED|95.0|0.7|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.70|0.4768
91511289|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1484|TWO_SIDED|95.0|0.84|3.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.13|0.84|0.1484
91511290|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8957|TWO_SIDED|95.0|0.5|2.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.18|0.50|0.8957
91511291|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5681|TWO_SIDED|95.0|0.33|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.85|0.33|0.5681
91511292|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.0074|TWO_SIDED|95.0|1.35|10.88|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||10.88|1.35|0.0074
91511293|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1637|TWO_SIDED|95.0|0.06|1.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.70|0.06|0.1637
91511294|NCT00113516|182894191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.4328|TWO_SIDED|95.0|0.23|29.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||29.12|0.23|0.4328
91511295|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4269|TWO_SIDED|95.0|0.72|2.21|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.21|0.72|0.4269
91511296|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.0|0.51|1.86|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||1.86|0.51|0.9290
91511297|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8195|TWO_SIDED|95.0|0.44|1.91|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.91|0.44|0.8195
91511298|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.221|TWO_SIDED|95.0|0.26|1.38|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.38|0.26|0.2210
91511299|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.4297|TWO_SIDED|95.0|0.24|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||1.85|0.24|0.4297
91511300|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0522|TWO_SIDED|95.0|0.06|1.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.11|0.06|0.0522
91511301|NCT00113516|182894192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.6949|TWO_SIDED|95.0|0.05|7.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||7.00|0.05|0.6949
91511302|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.766|TWO_SIDED|95.0|0.51|1.65|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.65|0.51|0.7660
91511303|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.2682|TWO_SIDED|95.0|0.72|3.23|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.23|0.72|0.2682
91511304|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2726|TWO_SIDED|95.0|0.69|3.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.70|0.69|0.2726
91511305|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.2787|TWO_SIDED|95.0|0.22|1.55|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.55|0.22|0.2787
91511306|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.4||||0.0241|TWO_SIDED|95.0|1.09|17.56|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||17.56|1.09|0.0241
91511307|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.0943|TWO_SIDED|95.0|0.59|48.81|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||48.81|0.59|0.0943
91756908|NCT03429543|183406528|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
91756909|NCT03429543|183406529|OTHER||Adjusted mean difference|-0.68||||0.4828|TWO_SIDED|95.0|-2.86|1.49|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.49|-2.86|0.4828
91756910|NCT03429543|183406529|OTHER||Adjusted mean difference|-0.38||||0.7047|TWO_SIDED|95.0|-2.64|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.88|-2.64|0.7047
91756911|NCT03429543|183406530|OTHER|||||||0.8626|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.8626
91756912|NCT03429543|183406530|OTHER|||||||0.2827|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.2827
91756913|NCT03429543|183406531|OTHER||Mean Difference (Final Values)|-5.41||||0.6438|TWO_SIDED|95.0|-28.49|17.67|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||17.67|-28.49|0.6438
91756914|NCT03429543|183406531|OTHER||Mean Difference (Final Values)|-35.18||||0.0035|TWO_SIDED|95.0|-58.61|-11.74|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||-11.74|-58.61|0.0035
91756915|NCT03429543|183406531|OTHER||Mean Difference (Final Values)|38.62||||0.031|TWO_SIDED|95.0|4.54|72.7|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||72.70|4.54|0.0310
91756916|NCT03429543|183406531|OTHER||Mean Difference (Final Values)|20.05||||0.1994|TWO_SIDED|95.0|-13.01|53.11|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||53.11|-13.01|0.1994
91756917|NCT03429543|183406532|OTHER||Mean Difference (Final Values)|1.46||||0.1394|TWO_SIDED|95.0|-0.48|3.41|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.41|-0.48|0.1394
91756918|NCT03429543|183406532|OTHER||Mean Difference (Final Values)|-0.75||||0.4476|TWO_SIDED|95.0|-2.68|1.19|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.19|-2.68|0.4476
91756919|NCT03429543|183406532|OTHER||Mean Difference (Final Values)|0.05||||0.9789|TWO_SIDED|95.0|-3.8|3.9|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.90|-3.80|0.9789
91756920|NCT03429543|183406532|OTHER||Mean Difference (Final Values)|-1.35||||0.5092|TWO_SIDED|95.0|-5.68|2.99|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.99|-5.68|0.5092
91756921|NCT03429543|183406533|OTHER||Mean Difference (Final Values)|0.91||||0.587|TWO_SIDED|95.0|-2.4|4.22|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.22|-2.40|0.5870
91756922|NCT03429543|183406533|OTHER||Mean Difference (Final Values)|-1.42||||0.3967|TWO_SIDED|95.0|-4.72|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.88|-4.72|0.3967
91511308|NCT00113516|182894193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.8084|TWO_SIDED|95.0|0.04|11.79|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||11.79|0.04|0.8084
91511309|NCT03915548|182894198|OTHER|Group by time interaction (difference in trajectory)||||||0.54||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,747)=0.88|||.54
91511310|NCT03915548|182894199|OTHER|Group by time interaction (difference in trajectory)||||||0.09||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,746.4)=2.64|||.09
91756923|NCT03429543|183406533|OTHER||Mean Difference (Final Values)|2.53||||0.5414|TWO_SIDED|95.0|-6.42|11.47|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||11.47|-6.42|0.5414
91756924|NCT03429543|183406533|OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-10.13|10.13|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||10.13|-10.13|0.9995
91756925|NCT03429543|183406534|OTHER||Mean Difference (Final Values)|1.5||||0.2433|TWO_SIDED|95.0|-1.03|4.02|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.02|-1.03|0.2433
91759883|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|||||TWO_SIDED|95.0|-3.87|9.96||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.96|-3.87|
91511311|NCT03915548|182894200|OTHER|Group by time interaction (difference in trajectory)||||||0.55||||||Adjusted|Mixed Models Analysis|Poisson model with log link; multiple-degree-of-freedom test|||F(3,717)=0.7|||.55
91511312|NCT03915548|182894201|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,394.7)=0.18|||.99
91511313|NCT03915548|182894202|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Overall score adjusted P = 0.99 Physical subscale adjusted P = 0.99 Social subscale adjusted P = 0.99 Emotional subscale adjusted P = 0.99 Functional subscale adjusted P = 0.99|Mixed Models Analysis|multiple-degree-of-freedom test|||"Group by time interaction:~Overall score: F(3,731.3)=0.03 Physical subscale: F(3,744.5)=0.23 Social subscale: F(3,740.6)=0.32 Emotional subscale: F(3,743)=0.46 Functional subscale: F(3,746.1)=0.3"|||0.99
91511314|NCT03915548|182894203|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Active coping adjusted P = 0.99 Planning adjusted P = 0.21 Positive reframing adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Active planning: F(3,746)=0.8 Planning: F(3,744.8)=2.93 Positive reframing = F(3,742)=0.21|||0.99
91511315|NCT03915548|182894204|OTHER|Group by time interaction (difference in trajectory)||||||0.02|||||||Mixed Models Analysis|multiple-degrees-of-freedom test|||Disengagement: F(3,741.2)=5.09 Reengagement: F(3,745.7)=0.81|||0.02
91511316|NCT03915548|182894205|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Anxiety adjusted P = 0.99 Depression adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Anxiety: F(3,737.5)=0.17 Depression: F(3,733.6)=0.85|||0.99
91756926|NCT03429543|183406534|OTHER||Mean Difference (Final Values)|0.02||||0.9878|TWO_SIDED|95.0|-2.52|2.56|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.56|-2.52|0.9878
91756927|NCT03429543|183406534|OTHER||Mean Difference (Final Values)|3.33||||0.567|TWO_SIDED|95.0|-9.0|15.65|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||15.65|-9.00|0.5670
91756928|NCT03429543|183406534|OTHER||Mean Difference (Final Values)|-6.62||||0.2348|TWO_SIDED|95.0|-18.19|4.95|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.95|-18.19|0.2348
91756929|NCT03429543|183406535|OTHER||Rate difference (percentage)|6.0||||0.3536|TWO_SIDED|95.0|-7.7|19.9|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.9|-7.7|0.3536
91756930|NCT03429543|183406535|OTHER||Rate difference (percentage)|11.7||||0.0914|TWO_SIDED|95.0|-2.4|26.3|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||26.3|-2.4|0.0914
91756931|NCT03429543|183406535|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
91756932|NCT03429543|183406535|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
91756933|NCT03429543|183406536|OTHER||Rate difference (percentage)|2.4||||0.7789|TWO_SIDED|95.0|-15.2|19.5|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.5|-15.2|0.7789
91756934|NCT03429543|183406536|OTHER||Rate difference (percentage)|10.1||||0.2548|TWO_SIDED|95.0|-7.7|28.1|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||28.1|-7.7|0.2548
91756935|NCT03429543|183406536|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
91756936|NCT03429543|183406536|OTHER||Rate difference (percentage)|26.7||||0.5671|TWO_SIDED|90.0|-30.8|70.8|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||70.8|-30.8|0.5671
91756937|NCT01600092|183406537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G1||1.07|0.79|
91513559|NCT03029208|182898974|SUPERIORITY||LS mean difference|-3.4||||0.7651|TWO_SIDED|95.0|-12.7|5.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||5.9|-12.7|0.7651
91756938|NCT01600092|183406537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G2||1.33|0.99|
91511317|NCT03915548|182894206|SUPERIORITY||Cohen's d|0.26||||0.09|TWO_SIDED|95.0|-0.01|0.54||Importance subscale: Adjusted P = .09 Performance subscale: Adjusted P = \<.001 Satisfaction subscale: Adjusted P = \<.001|Mixed Models Analysis|multiple-degrees-of-freedom test|Importance subscale: Cohen's d = 0.26 (-.01, 0.54) Performance subscale: Cohen's d = 0.60 (0.32, 0.87) Satisfaction subscale: Cohen's d = 0.76 (0.48, 1.02)|||0.54|-.01|.09
91756939|NCT01600092|183406537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|3.2|||||TWO_SIDED|95.0|2.75|3.74|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G3||3.74|2.75|
91756940|NCT01600092|183406537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G4||1.20|0.94|
91756941|NCT01600092|183406537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype P1A\[8\]||1.35|1.00|
91756942|NCT01561963|183406542|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% confidence interval (CI) limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|96.35|||||TWO_SIDED|90.0|88.56|104.82|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.82|88.56|
91756943|NCT01561963|183406542|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.88|||||TWO_SIDED|90.0|25.63|30.34|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.34|25.63|
91756944|NCT01561963|183406543|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|95.71|||||TWO_SIDED|90.0|87.99|104.12|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.12|87.99|
91756945|NCT01561963|183406543|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.96|||||TWO_SIDED|90.0|25.7|30.41|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.41|25.70|
91756946|NCT01561963|183406544|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|113.07|||||TWO_SIDED|90.0|103.18|123.91|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||123.91|103.18|
91756947|NCT01561963|183406544|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|56.8|||||TWO_SIDED|90.0|51.84|62.25|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||62.25|51.84|
91756948|NCT01561963|183406545|OTHER||Median Difference|-0.25||||0.2656|TWO_SIDED|90.0|-0.75|0.0|||Wilcoxon signed rank test||Apremilast + IV Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-0.75|0.2656
91756949|NCT01561963|183406545|OTHER||Median Difference|-0.5||||0.1141|TWO_SIDED|90.0|-1.0|0.0|||Wilcoxon signed rank test||Apremilast + Multiple Dose Oral Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-1.00|0.1141
91756950|NCT04018313|183406549|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|105.62|||||TWO_SIDED|90.0|95.91|116.31||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||116.31|95.91|
91756951|NCT04018313|183406549|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax|Ratio of geometric least square means|98.72|||||TWO_SIDED|90.0|89.76|108.58||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.58|89.76|
91511318|NCT03217136|182894217|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|18.1|||||TWO_SIDED|95.0|-2.6|41.1||||||Difference in Percentage (C/T+MTZ minus MERO)||41.1|-2.6|
91759884|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.31|||||TWO_SIDED|95.0|3.43|17.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.18|3.43|
91511319|NCT03217136|182894218|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|2.9|||||TWO_SIDED|95.0|-12.9|9.9||||||Difference in Percentage (C/T+MTZ minus MERO)||9.9|-12.9|
91533958|NCT04949399|182945271|SUPERIORITY||Difference (%)|45.2|||<|0.0001|TWO_SIDED|95.0|37.1|53.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||53.2|37.1|<0.0001
91759885|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.31|||||TWO_SIDED|95.0|-3.59|10.22||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.22|-3.59|
91759886|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.73|||||TWO_SIDED|95.0|-4.1|9.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.57|-4.10|
91759887|NCT01393639|183411984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62|||||TWO_SIDED|95.0|-1.25|12.48||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.48|-1.25|
91759888|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-7.56|8.31||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.31|-7.56|
91759889|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.15|||||TWO_SIDED|95.0|-16.01|-0.3||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.30|-16.01|
91759890|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.01|-6.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.20|-22.01|
91759891|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-19.7|-4.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.06|-19.70|
91759892|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-7.33|8.48||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.48|-7.33|
91759893|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.89|||||TWO_SIDED|95.0|-20.8|-4.98||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.98|-20.80|
91759894|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-9.31|8.58||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.58|-9.31|
91759895|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|||||TWO_SIDED|95.0|-18.43|-0.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.53|-18.43|
91759896|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42|||||TWO_SIDED|95.0|-22.39|-4.44||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-22.39|
91533959|NCT04949399|182945272|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.8|-4.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.6|-6.8|<0.0001
91533960|NCT04949399|182945273|SUPERIORITY||Difference (SE)|-5.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-6.7|-4.5||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-4.5|-6.7|<0.0001
91756952|NCT04018313|183406549|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|93.47|||||TWO_SIDED|90.0|85.09|102.68||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||102.68|85.09|
91756953|NCT04018313|183406550|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|104.0|||||TWO_SIDED|90.0|94.96|113.89||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.89|94.96|
91756954|NCT04018313|183406550|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|99.3|||||TWO_SIDED|90.0|90.79|108.61||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.61|90.79|
91756955|NCT04018313|183406550|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|95.48|||||TWO_SIDED|90.0|87.36|104.37||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||104.37|87.36|
91756956|NCT04018313|183406551|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|113.14|||||TWO_SIDED|90.0|103.15|124.11||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||124.11|103.15|
91756957|NCT04018313|183406551|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|103.88|||||TWO_SIDED|90.0|94.83|113.8||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.80|94.83|
91756958|NCT04018313|183406551|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|91.82|||||TWO_SIDED|90.0|83.87|100.52||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||100.52|83.87|
91756959|NCT03592368|183406802|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91756960|NCT03592368|183406804|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91756961|NCT03592368|183406805|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||||||0.12
91533961|NCT04949399|182945273|SUPERIORITY||Difference (SE)|-5.0|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.0|-3.9||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.9|-6.0|<0.0001
91756962|NCT01107665|183406816|OTHER||Log Rank HR|0.784||||0.49|TWO_SIDED|95.0|0.41|1.54|||Log Rank|||||1.54|.41|0.49
91756963|NCT02814175|183406824|OTHER|Between group difference|point estimate difference|28.3|||<|0.001|TWO_SIDED|95.0|17.8|38.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor which is the duration of prior MTX 15 mg ew use of ≤ 3 months or \> 3 months.||||38.9|17.8|< 0.001
91756964|NCT02170870|183406837|SUPERIORITY|||||||0.06|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs diabetics adjusted for treatment status (ie, exendin or placebo)||||0.06
91533962|NCT04949399|182945273|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
91533963|NCT01871285|182945280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
91533964|NCT01871285|182945280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
91533965|NCT01871285|182945281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
91533966|NCT01871285|182945281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
91533967|NCT05397470|182945282|OTHER||Least square mean difference|0.003||||0.7501|TWO_SIDED|95.0|-0.014|0.02|||Mixed Model Repeated Measures|||||0.020|-0.014|0.7501
91756965|NCT02170870|183406837|SUPERIORITY|||||||0.0001|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs functional dyspepsia adjusted for treatment status (ie, exendin or placebo)||||0.0001
91756966|NCT00125957|183406839|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||.04
91756967|NCT00125957|183406840|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||0.09
91756968|NCT04207749|183406849|NON_INFERIORITY|Noninferiority in CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least Squares Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.02||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures||Least squares mean difference (LID015385 minus Biofinity).|||0.02|-0.00|
91756969|NCT04207749|183406850|NON_INFERIORITY|Proportion of subjects is presented. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Farrington-Manning||Lens difference (LID015385 minus Biofinity)|||0.04|-0.06|
91756970|NCT03416127|183406857|OTHER|||||||0.031|||||||Kruskal-Wallis|||||||0.031
91756971|NCT03416127|183406858|OTHER|||||||0.963|||||||Kruskal-Wallis|||||||0.963
91756972|NCT03416127|183406859|OTHER|||||||0.236|||||||Kruskal-Wallis|||||||0.236
91756973|NCT03416127|183406860|OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
91756974|NCT03416127|183406861|OTHER|||||||0.017|||||||Kruskal-Wallis|||||||0.017
91756975|NCT03416127|183406862|OTHER|||||||0.162|||||||Kruskal-Wallis|||||||0.162
91756976|NCT03416127|183406863|OTHER|||||||0.686|||||||Kruskal-Wallis|||||||0.686
91756977|NCT03416127|183406864|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91756978|NCT03416127|183406865|OTHER|||||||0.945|||||||Kruskal-Wallis|||||||0.945
91756979|NCT03416127|183406866|OTHER|||||||0.332|||||||Kruskal-Wallis|||||||0.332
91756980|NCT03416127|183406867|OTHER|||||||0.075|||||||Kruskal-Wallis|||||||0.075
91756981|NCT03416127|183406868|OTHER|||||||0.903|||||||Kruskal-Wallis|||||||0.903
91756982|NCT03416127|183406869|OTHER|||||||0.697|||||||Kruskal-Wallis|||||||0.697
91756983|NCT03416127|183406870|OTHER|||||||0.668|||||||Kruskal-Wallis|||||||0.668
91756984|NCT03416127|183406871|OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
91756985|NCT03416127|183406872|OTHER|||||||0.318|||||||Kruskal-Wallis|||||||0.318
91533968|NCT01257503|182945328|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in same participant||change in runny nose||||.86
91756986|NCT03416127|183406873|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
91756987|NCT03416127|183406874|OTHER|||||||0.376|||||||Kruskal-Wallis|||||||0.376
91756988|NCT03416127|183406875|OTHER|||||||0.21|||||||Kruskal-Wallis|||||||0.210
91756989|NCT03416127|183406876|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
91756990|NCT03416127|183406877|OTHER|||||||0.059|||||||Kruskal-Wallis|||||||0.059
91756991|NCT03416127|183406878|OTHER|||||||0.978|||||||Kruskal-Wallis|||||||0.978
91756992|NCT03416127|183406879|OTHER|||||||0.122|||||||Kruskal-Wallis|||||||0.122
91756993|NCT03416127|183406880|OTHER|||||||0.551|||||||Kruskal-Wallis|||||||0.551
91756994|NCT00924508|183406881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
91756995|NCT00924508|183406881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
91756996|NCT00924508|183406881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
91756997|NCT00741013|183406901|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Only a single statistical analysis was performed upon completion of the study.|ANOVA|||One-way analysis of variance was performed to determine whether lovastatin or rhAPC effectively reduced endotoxin-induced lung inflammation.||||<0.05
91756998|NCT01754493|183406909|SUPERIORITY_OR_OTHER_LEGACY||Slope|-18.24|||<|0.05|TWO_SIDED|95.0|-23.44|-12.63|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-12.63|-23.44|<.05
91756999|NCT01754493|183406910|SUPERIORITY_OR_OTHER_LEGACY||Slope|-20.71|||<|0.05|TWO_SIDED|95.0|-27.44|-13.97|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-13.97|-27.44|<0.05
91757000|NCT01754493|183406911|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.59|||<|0.05|TWO_SIDED|95.0|-2.16|-1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.03|-2.16|<0.05
91757001|NCT01754493|183406911|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.55|||<|0.05|TWO_SIDED|95.0|-1.99|-1.11|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.11|-1.99|<0.05
91757002|NCT01754493|183406912|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.03|||<|0.05|TWO_SIDED|95.0|-1.16|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-1.16|<0.05
91757003|NCT01754493|183406912|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.47|||<|0.05|TWO_SIDED|95.0|-1.07|2.01|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis||2.01|-1.07|<0.05
91757004|NCT01754493|183406912|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.59|||<|0.05|TWO_SIDED|95.0|-2.28|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-2.28|<0.05
91757005|NCT01754493|183406912|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.35|||<|0.05|TWO_SIDED|95.0|-1.56|0.87|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||.87|-1.56|<0.05
91757006|NCT01754493|183406912|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.48|||<|0.05|TWO_SIDED|95.0|-2.0|1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.03|-2.00|<0.05
91757007|NCT01754493|183406913|SUPERIORITY_OR_OTHER_LEGACY||Slope|-4.38|||<|0.05|TWO_SIDED|95.0|-7.39|-1.36|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.36|-7.39|<0.05
91757008|NCT01452919|183406932|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.73|STANDARD_ERROR_OF_MEAN|1.25||0.17||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.170
91757009|NCT01452919|183406933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.5||0.109||95.0||||Two-sided p-value. P-value is for Week 0.5.|Type 3 sums of squares|||||||0.109
91757010|NCT01452919|183406933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.372||95.0||||Two-sided p-value. P-value is for Week 1.|Type 3 sums of squares|||||||0.372
91757011|NCT01452919|183406933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.555||95.0||||Two-sided p-value. P-value is for Week 1.5.|Type 3 sums of squares|||||||0.555
91757012|NCT01452919|183406933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.806||95.0||||Two-sided p-value. P-value is for Week 2.|Type 3 sums of squares|||||||0.806
91757013|NCT01452919|183406934|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.762||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.762
91757014|NCT01452919|183406935|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.506||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.506
91757015|NCT01452919|183406936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.515||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.515
91533969|NCT01257503|182945328|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in sneeze||||.89
91757016|NCT01452919|183406939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.966||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.966
91757017|NCT01452919|183406940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.92|STANDARD_ERROR_OF_MEAN|0.73||0.895||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.895
91757018|NCT00151476|183406945|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|14.49||||||95.0|3.48|301.64|||||Kaplan-Meier Estimate of Time to Event (months).|"Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.~Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.~Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints"||301.64|3.48|
91757019|NCT00151476|183406945|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.06||||||95.0|3.48|11.76|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||11.76|3.48|
91757020|NCT00151476|183406945|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.52||||||95.0|3.48|14.49|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||14.49|3.48|
91757021|NCT00151476|183406946|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.98||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
91757022|NCT00151476|183406946|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
91757023|NCT00151476|183406947|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|137.34||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.||183.48|104.73|
91757024|NCT00151476|183406947|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|169.94||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||183.48|104.73|
91757025|NCT00151476|183406948|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|11.28||||||95.0|9.07|38.24|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||38.24|9.07|
91757026|NCT00151476|183406949|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.63||||||95.0|8.05|48.03|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||48.03|8.05|
91757027|NCT00151476|183406949|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|40.21||||||95.0|8.31|105.68|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||105.68|8.31|
91757028|NCT00151476|183406949|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|16.03|56.34|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||56.34|16.03|
91757029|NCT00151476|183406949|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.22||||||95.0|12.35|40.31|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||40.31|12.35|
91757030|NCT00151476|183406951|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|21.22||||||95.0|4.07|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|4.07|
91757031|NCT00151476|183406951|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|3.68|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|3.68|
91757032|NCT03446456|183406958|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in changes of BOLD signal in the brain.|Mean Difference (Final Values)|0.00264||||0.982|TWO_SIDED|||||Bonferroni corrected|t-test, 2 sided|||Percentage of BOLD signal change was calculated as the BOLD signal in the right supplementary motor area (SMA, a typical brain area responding to pain stimulation), divided by the BOLD signal of the whole-brain average during the 24 trials of 20-second painful stimulations. The percentage of BOLD signal changes in SMA during the 20-second painful stimulations were compared between the Saline group and the Vasopressin group using an equivalence test.||||0.982
91757033|NCT03446456|183406959|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in heating temperature that was used for the testing phase.|Mean Difference (Final Values)|-0.282||||0.269|TWO_SIDED|||||Bonferroni corrected|ANCOVA|The drug group (Vasopressin vs. Saline) was set as a between-subject factor. Age and race were treated as covariates.||||||0.269
91757034|NCT03446456|183406960|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in implicit racial biases.|Mean Difference (Final Values)|-0.04||||0.378|TWO_SIDED||||||ANCOVA|Drug group (Vasopressin vs. Saline) was set as between-subject factor. Age and race were treated as covariates.||"Response latencies were recorded to calculate the IAT difference score (D). A difference score (D) was calculated based on the following steps: 1) Compute the standard deviation (SD) of response latencies from overall trials; 2) M1 is the mean of the response latencies in the condition where White people and good share the same response key. M2 is the mean of the latencies in the condition where African-American/Asian people and good share the same response key; 3) D = (M2-M1)/SD."||||0.378
91757035|NCT03446456|183406961|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in self-reported pain intensity ratings.|Mean Difference (Final Values)|-2.35||||0.014|TWO_SIDED|||||Bonferroni corrected|Mixed Models Analysis|Age, race, and heating temperature used during the testing phase were treated as covariates.||||||0.014
91757036|NCT04856904|183407003|SUPERIORITY||Bilateral difference|-3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.4|-2.0|||Student's t-test for paired samples|||||-2|-4.4|< 0.0001
91757037|NCT04856904|183407004|SUPERIORITY||Bilateral difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.9476|TWO_SIDED|95.0|-0.3|0.3|||Student's t-test for paired samples|||Week 1: Trifarotene 50 mcg/g, vehicle cream||0.3|-0.3|= 0.9476
91757038|NCT04856904|183407004|SUPERIORITY||Bilateral difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25|=|0.0248|TWO_SIDED|95.0|-1.1|-0.1|||Student's t-test for paired samples|||Week 2: Trifarotene 50 mcg/g, vehicle cream||-0.1|-1.1|= 0.0248
91757039|NCT04856904|183407004|SUPERIORITY||Bilateral difference|-0.8|STANDARD_ERROR_OF_MEAN|0.29|=|0.0072|TWO_SIDED|95.0|-1.4|-0.2|||Student's t-test for paired samples|||Week 4: Trifarotene 50 mcg/g, vehicle cream||-0.2|-1.4|= 0.0072
91757040|NCT04856904|183407004|SUPERIORITY||Bilateral difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7|||Student's t-test for paired samples|||Week 8: Trifarotene 50 mcg/g, vehicle cream||-0.7|-2.1|< 0.0001
91757041|NCT04856904|183407004|SUPERIORITY||Bilateral difference|-2.1|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.9|-1.3|||Student's t-test for paired samples|||Week 12: Trifarotene 50 mcg/g, vehicle cream||-1.3|-2.9|< 0.0001
91757042|NCT04856904|183407004|SUPERIORITY||Bilateral difference|-2.7|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6|||Student's t-test for paired samples|||Week 16: Trifarotene 50 mcg/g, vehicle cream||-1.6|-3.8|< 0.0001
91757043|NCT04856904|183407004|SUPERIORITY||Bilateral difference|-2.5|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Student's t-test for paired samples|||Week 20: Trifarotene 50 mcg/g, vehicle cream||-1.5|-3.5|< 0.0001
91757044|NCT01641822|183407020|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.743||||0.25|TWO_SIDED|95.0|0.446|1.238|||Negative binomial regression|||Ratio between rates||1.238|0.446|0.25
91757045|NCT01641822|183407021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.16|TWO_SIDED|95.0|-0.55|3.2||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in FEV1 % predicted||3.2|-0.55|0.16
91757046|NCT01641822|183407022|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||Comparison of percentages||||0.67
91511320|NCT03217136|182894219|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-14.3|||||TWO_SIDED|95.0|-26.67|4.93||||||Difference in Percentage (C/T+MTZ minus MERO)||4.93|-26.67|
91757047|NCT01641822|183407023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.71|TWO_SIDED|95.0|0.5|1.59|||Log Rank|||Comparison of time to exacerbation||1.59|0.50|0.71
91757048|NCT01641822|183407024|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.642||||0.14|TWO_SIDED|95.0|0.355|1.164|||Negative binomial regression|||Comparison of hospitalization rate||1.164|0.355|0.14
91757049|NCT01641822|183407025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06||||0.21|TWO_SIDED|95.0|-1.71|7.82||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in CFQ-R RSS||7.82|-1.71|0.21
91757050|NCT03847909|183407038|SUPERIORITY|P value is from an ANCOVA model with treatment group as the main effect, age category, baseline eGFR category, baseline Uox value as covariates for adjustment.|Difference of Least Mean Square|5171.7|STANDARD_ERROR_OF_MEAN|1144.07|<|0.0001|TWO_SIDED|95.0|2929.3|7414.2|||ANCOVA|||||7414.2|2929.3|<0.0001
91511321|NCT03217136|182894220|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-19.1|||||TWO_SIDED|95.0|-30.18|-2.89||||||Difference in Percentage (C/T+MTZ minus MERO)||-2.89|-30.18|
91511322|NCT03217136|182894221|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-11.2|||||TWO_SIDED|95.0|-23.66|9.61||||||Difference in Percentage (C/T+MTZ minus MERO)||9.61|-23.66|
91511323|NCT03217136|182894222|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-16.3|||||TWO_SIDED|95.0|-27.59|1.39||||||Difference in Percentage (C/T+MTZ minus MERO)||1.39|-27.59|
91511324|NCT03091751|182894240|OTHER||Mean Difference (Final Values)|10.41||||0.77|TWO_SIDED|95.0|-224.88|245.7|||t-test, 1 sided|||||245.70|-224.88|0.77
91511325|NCT03091751|182894241|OTHER||Mean Difference (Final Values)|0.3068||||0.002|TWO_SIDED|95.0|0.1501|0.4635|||t-test, 1 sided|||||0.4635|0.1501|0.002
91511326|NCT03091751|182894242|OTHER||Mean Difference (Final Values)|-3.3||||0.3|TWO_SIDED|95.0|-8.9|2.3|||t-test, 1 sided|||||2.3|-8.9|0.30
91511327|NCT03091751|182894243|OTHER||Mean Difference (Final Values)|-0.0058||||0.16|TWO_SIDED|95.0|-0.0119|0.0003|||t-test, 1 sided|||||0.0003|-0.0119|0.16
91511328|NCT03091751|182894244|OTHER||Mean Difference (Final Values)|-7.609||||0.02|TWO_SIDED|95.0|-13.344|-1.879|||t-test, 1 sided|||||-1.879|-13.344|0.02
91511329|NCT01161329|182894249|NON_INFERIORITY_OR_EQUIVALENCE|It was estimated that 128 individuals would be required for 80 % Power with a type I error of 5% to detect a 2-point difference in BBS with a standard deviation of +/- 4 points. Because of the slow recruitment and the statistically significant improvements observed in the primary outcome in the intervention group during an interim analysis the study was finalized with fewer participants than had been initially calculated.||||||0.001||||||The Bonferroni method was used to assess longitudinal Changes and correct for multiple comparisons, with significance set at p\<0.016 to minimize the risk for type I errors.|Wilcoxon (Mann-Whitney)|||Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.||||0.001
91511330|NCT01161329|182894250|SUPERIORITY_OR_OTHER|||||||0.09||||||The p-value for the man differnece in SPPB between grpoups att three months was 0.09|Wilcoxon (Mann-Whitney)|||||||0.09
91511331|NCT01448850|182894271|SUPERIORITY_OR_OTHER||Rate ratio|0.92||||0.645|TWO_SIDED|90.0|0.68|1.25||Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.|Poisson regression|||||1.25|0.68|0.645
91511332|NCT01591746|182894310|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91511333|NCT01591746|182894311|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
91511334|NCT01591746|182894312|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Right breast initial percent volume expansion||||0.45
91511335|NCT01591746|182894312|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Left breast initial percent volume expansion||||0.98
91511336|NCT01591746|182894313|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91511337|NCT01591746|182894314|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91511338|NCT01591746|182894315|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91511339|NCT03495908|182894326|NON_INFERIORITY|Non-inferiority margin is 0.4% HbA1c|Mean Difference (Net)|-0.2207||||0.007|TWO_SIDED|95.0|-0.6654|0.2241||Non-inferiority p-value based on the 0.4% non-inferiority margin|Mixed Models Analysis||RHI - RAI estimated treatment difference. Upper confidence interval 0.22 is less than the 0.4% non-inferiority margin.|RHI - RAI estimated treatment difference (ETD) in HbA1c. Per-protocol analysis is the pre-specified primary outcome.||0.2241|-0.6654|0.007
91511340|NCT03495908|182894327|SUPERIORITY|Comparison of Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||||0.82|||||||Fisher Exact|||Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||.82
91511341|NCT03495908|182894328|SUPERIORITY|Analysis of the 7-point profiles within the ITT population (n=136)|Risk Ratio (RR)|0.925||||0.861|TWO_SIDED|95.0|0.386|2.217||Results are from a Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Regression, Poisson|Poisson regression model with repeated measures; generalized estimating equations (GEE) approach|The incidence rate ratio quantitates the risk of hypoglycemia in the RHI group (RR numerator) compared with the RAI group (RR numerator). Results from Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.||2.217|0.386|0.861
91533970|NCT01257503|182945328|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in cough||||.45
91533971|NCT01257503|182945328|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in congestion||||.82
91533972|NCT01257503|182945329|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in irritability||||.61
91533973|NCT01257503|182945329|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in lethargy||||.97
91757051|NCT00869401|183407075|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.222|TWO_SIDED|95.0|0.54|1.16||Using Logrank Test|Log Rank|||||1.16|0.54|.222
91757052|NCT00869401|183407077|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.806||||0.183|TWO_SIDED|95.0|0.59|1.11|||Log Rank|||||1.11|0.59|0.183
91757053|NCT00082381|183407084|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and insulin glargine is less than 0.4%.)|Mean Difference (Final Values)|0.05||||0.4602||95.0|-0.09|0.2|||ANCOVA|||||0.20|-0.09|0.4602
91757054|NCT00082381|183407085|SUPERIORITY_OR_OTHER|||||||0.7839||95.0|||||Fisher Exact|||||||0.7839
91757055|NCT00082381|183407086|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91511342|NCT03495908|182894329|SUPERIORITY||Mean Difference (Net)|-0.01073||||0.415|TWO_SIDED|95.0|-0.03674|0.01528|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|RHI versus RAI for Insulin Intent-to-treat Population N=136 Mixed Model Estimates for Insulin TDD U/kg I||0.01528|-0.03674|0.415
91757056|NCT00082381|183407087|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91757057|NCT00082381|183407089|SUPERIORITY_OR_OTHER|||||||0.3002||95.0|||||Fisher Exact|||||||0.3002
91757058|NCT00082381|183407090|SUPERIORITY_OR_OTHER|||||||0.3385||95.0|||||ANCOVA|||||||0.3385
91757059|NCT01786252|183407104|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.||||<0.05
91757060|NCT01786252|183407104|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.||||>0.05
91757061|NCT01786252|183407104|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare stromal staging between hCG and IVF media group.||||<0.01
91757062|NCT01786252|183407104|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.||||>0.05
91757063|NCT01786252|183407105|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91757064|NCT01786252|183407106|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91757065|NCT01786252|183407107|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91757066|NCT03322423|183407119|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.058|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.08|-0.035|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.035|-0.080|
91757067|NCT03322423|183407119|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.076|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.099|-0.054|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.054|-0.099|
91757068|NCT03322423|183407120|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
91757069|NCT03322423|183407120|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
91757070|NCT03322423|183407121|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|45.5|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|95.0|41.2|49.9|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||49.9|41.2|
91757071|NCT03322423|183407121|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|46.4|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|42.1|50.8|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||50.8|42.1|
91757072|NCT02453555|183407133|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.36|-0.91|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 24 in Empagliflozin 10 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 24 in Linagliptin 5 mg + Placebo 10 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.91|-1.36|<0.0001
91511343|NCT03495908|182894330|SUPERIORITY||Mean Difference (Net)|-1.0776||||0.32|TWO_SIDED|95.0|-3.2139|1.0587|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|||1.0587|-3.2139|0.320
91511344|NCT03495908|182894331|SUPERIORITY||Mean Difference (Net)|-265.85|||<|0.0001|TWO_SIDED|95.0|-288.6|-243.11|||Mixed Models Analysis||Estimated Treatment Difference (RHI-RAI) from repeated measures mixed model least squares estimates|||-243.11|-288.60|<0.0001
91511345|NCT03495908|182894332|NON_INFERIORITY|Change in A1C Non-inferiority Margin is 0.4%|Mean Difference (Net)|-0.1317||||0.02|TWO_SIDED|95.0|-0.5838|0.3205||p-value for non-inferiority|Mixed Models Analysis||Between Group Difference (RHI-RAI) mixed effects repeated measures model analysis.Upper confidence interval 0.32 is less than the 0.4% non-inferiority margin.|Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI||0.3205|-0.5838|0.02
91511346|NCT01109316|182894334|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.48|||||TWO_SIDED|95.0|0.2|0.76|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.|This was the primary gated analysis.||0.76|0.20|
91511347|NCT01109316|182894335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.22|||||TWO_SIDED|95.0|-0.07|0.52|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.52|-0.07|
91757073|NCT02453555|183407135|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.99|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in All Empagliflozin group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.99|-1.45|<0.0001
91757074|NCT02453555|183407136|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in Linagliptin 5 mg + Placebo 25 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.96|-1.45|<0.0001
91757075|NCT02453555|183407137|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.34|-0.84|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.84|-1.34|<0.0001
91757076|NCT03045341|183407138|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
91757077|NCT03045341|183407138|SUPERIORITY|Analyses used all available data.||||||0.58|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.58
91757078|NCT03045341|183407139|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
91757079|NCT03045341|183407139|SUPERIORITY|Analyses used all available data.||||||0.63|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.63
91757080|NCT03045341|183407140|SUPERIORITY|||||||0.004|||||||Chi-squared|||Analyses used all available data.||||.004
91757081|NCT03178669|183407146|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1806|TWO_SIDED|80.0|0.75|5.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||5.47|0.75|0.1806
91757082|NCT03178669|183407146|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6649|TWO_SIDED|80.0|0.2|2.24||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.24|0.20|0.6649
91757083|NCT03178669|183407146|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0247|TWO_SIDED|80.0|1.53|9.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||9.47|1.53|0.0247
91511348|NCT01109316|182894335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.25|||||TWO_SIDED|95.0|-0.05|0.56|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.56|-0.05|
91511349|NCT01109316|182894336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||||TWO_SIDED|95.0|-0.29|0.51|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.51|-0.29|
91511350|NCT01109316|182894336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|-0.41|0.73|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.73|-0.41|
91757084|NCT03178669|183407146|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3279|TWO_SIDED|80.0|0.52|3.88||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.88|0.52|0.3279
91533974|NCT01257503|182945329|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in fussiness||||.79
91757085|NCT03178669|183407147|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2115|TWO_SIDED|80.0|0.69|4.99||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||4.99|0.69|0.2115
91757086|NCT03178669|183407147|SUPERIORITY||Odds Ratio (OR)|0.3||||0.8498|TWO_SIDED|80.0|0.06|1.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.34|0.06|0.8498
91757087|NCT03178669|183407147|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0977|TWO_SIDED|80.0|1.01|6.62||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||6.62|1.01|0.0977
91757088|NCT03178669|183407147|SUPERIORITY||Odds Ratio (OR)|1.0||||0.522|TWO_SIDED|80.0|0.32|2.84||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.84|0.32|0.5220
91757089|NCT03178669|183407148|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2335|TWO_SIDED|80.0|0.74|2.94||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.94|0.74|0.2335
91757090|NCT03178669|183407148|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2511|TWO_SIDED|80.0|0.73|2.69||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.69|0.73|0.2511
91757091|NCT03178669|183407148|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1162|TWO_SIDED|80.0|0.96|3.52||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.52|0.96|0.1162
91757092|NCT03178669|183407148|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3467|TWO_SIDED|80.0|0.63|2.4||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.40|0.63|0.3467
91511351|NCT01109316|182894336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|||||TWO_SIDED|95.0|-0.18|0.24|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.24|-0.18|
91511352|NCT01109316|182894336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.56|0.27|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.27|-0.56|
91511353|NCT01109316|182894336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.48|0.6|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.60|-0.48|
91511354|NCT01109316|182894336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.85|0.65|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.65|-0.85|
91757093|NCT03178669|183407149|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6326|TWO_SIDED|80.0|0.5|1.5||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.50|0.50|0.6326
91757094|NCT03178669|183407149|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7127|TWO_SIDED|80.0|0.45|1.37||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.37|0.45|0.7127
91757095|NCT03178669|183407149|SUPERIORITY||Odds Ratio (OR)|1.3||||0.2658|TWO_SIDED|80.0|0.75|2.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.34|0.75|0.2658
91757096|NCT03178669|183407149|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8301|TWO_SIDED|80.0|0.36|1.16||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.16|0.36|0.8301
91757097|NCT03178669|183407150|SUPERIORITY||Odds Ratio (OR)|0.6||||0.7994|TWO_SIDED|80.0|0.32|1.27||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.27|0.32|0.7994
91757098|NCT03178669|183407150|SUPERIORITY||Odds Ratio (OR)|0.3||||0.9665|TWO_SIDED|80.0|0.16|0.72||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.72|0.16|0.9665
91757099|NCT03178669|183407150|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2049|TWO_SIDED|80.0|0.8|2.82||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.82|0.80|0.2049
91757100|NCT03178669|183407150|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6504|TWO_SIDED|80.0|0.42|1.6||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.60|0.42|0.6504
91757101|NCT03178669|183407151|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9207|TWO_SIDED|80.0|0.18|0.93||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.93|0.18|0.9207
91511355|NCT01109316|182894337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.02|0.14|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.14|-0.02|
91511356|NCT01109316|182894337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|||||TWO_SIDED|95.0|0.01|0.18|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.18|0.01|
91511357|NCT01109316|182894338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.5|1.75|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.75|0.50|
91511358|NCT01109316|182894338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.29|1.67|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.67|0.29|
91757102|NCT03178669|183407151|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9228|TWO_SIDED|80.0|0.19|0.92||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.92|0.19|0.9228
91757103|NCT03178669|183407151|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6636|TWO_SIDED|80.0|0.39|1.61||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.61|0.39|0.6636
91757104|NCT03178669|183407151|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7449|TWO_SIDED|80.0|0.34|1.41||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.41|0.34|0.7449
91511359|NCT01109316|182894338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.41|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.41|0.56|
91757105|NCT02914561|183407152|SUPERIORITY||Stratified Percentage Difference|12.7||||0.0017|TWO_SIDED|95.0|4.7|20.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||20.7|4.7|0.0017
91757106|NCT02914561|183407152|SUPERIORITY||Stratified Percentage Difference|5.2||||0.173|TWO_SIDED|95.0|-2.4|12.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.7|-2.4|0.1730
91533975|NCT01257503|182945329|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in appetite||||.81
91533976|NCT01257503|182945330|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 1||||.16
91533977|NCT01257503|182945330|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 2||||.70
91533978|NCT01257503|182945330|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 3||||.77
91757107|NCT02914561|183407152|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0023|TWO_SIDED|95.0|4.1|19.9|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||19.9|4.1|0.0023
91757108|NCT02914561|183407152|SUPERIORITY||Stratified Percentage Difference|1.8||||0.6038|TWO_SIDED|95.0|-5.2|8.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.7|-5.2|0.6038
91757109|NCT02914561|183407153|SUPERIORITY||Stratified Percentage Difference|5.5||||0.1365|TWO_SIDED|95.0|-2.0|12.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \>=1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.9|-2.0|0.1365
91511360|NCT01109316|182894338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.66|1.64|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.64|0.66|
91511361|NCT01109316|182894339|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
91511362|NCT01109316|182894340|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.164
91511363|NCT01109316|182894340|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.185
91511364|NCT01109316|182894341|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.736
91511365|NCT01109316|182894341|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.006
91511366|NCT01109316|182894341|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
91511367|NCT01109316|182894341|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.017
91511368|NCT01109316|182894342|SUPERIORITY_OR_OTHER|||||||0.471||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.471
91511369|NCT01109316|182894342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
91511370|NCT01109316|182894342|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.737
91511371|NCT01109316|182894342|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
91511372|NCT01109316|182894344|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.006
91511373|NCT01109316|182894344|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.002
91511374|NCT01109316|182894345|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.060
91511375|NCT01109316|182894345|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.486
91511376|NCT01109316|182894346|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.056
91511377|NCT01109316|182894346|SUPERIORITY_OR_OTHER|||||||0.805||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.805
91511378|NCT01109316|182894346|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.020
91511379|NCT01109316|182894346|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.051
91511380|NCT01559311|182894354|SUPERIORITY_OR_OTHER|||||||0.1734|||||||Wilcoxon (Mann-Whitney)|||"* H01: μ LVEF, 1= μ LVEF, 2a vs H1a: μ LVEF, 1 \< μ LVEF, 2a~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2a is the mean of LVEF at month 12 in CRT-P ON Gp,"||||0.1734
91533979|NCT01257503|182945330|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status at 7-10 day follow-up||||.41
91757110|NCT02914561|183407153|SUPERIORITY||Stratified Percentage Difference|2.4||||0.5103|TWO_SIDED|95.0|-4.8|9.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||9.5|-4.8|0.5103
91757111|NCT02914561|183407153|SUPERIORITY||Stratified Percentage Difference|0.1||||0.9797|TWO_SIDED|95.0|-6.5|6.6|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\<=1, \>1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||6.6|-6.5|0.9797
91757112|NCT02914561|183407153|SUPERIORITY||Stratified Percentage Difference|2.4||||0.4264|TWO_SIDED|95.0|-3.9|8.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.8|-3.9|0.4264
91757113|NCT02914561|183407154|SUPERIORITY||Stratified Percentage Difference|13.7||||0.0839|TWO_SIDED|95.0|-1.0|28.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||28.4|-1.0|0.0839
91757114|NCT02914561|183407154|SUPERIORITY||Stratified Percentage Difference|1.5||||0.8288|TWO_SIDED|95.0|-12.1|15.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||15.0|-12.1|0.8288
91757115|NCT02914561|183407155|SUPERIORITY||Stratified Percentage Difference|20.6||||0.0038|TWO_SIDED|95.0|8.2|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||33.1|8.2|0.0038
91757116|NCT02914561|183407155|SUPERIORITY||Stratified Percentage Difference|5.8||||0.3466|TWO_SIDED|95.0|-6.6|18.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||18.3|-6.6|0.3466
91533980|NCT01257503|182945331|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 1||||.10
91533981|NCT01257503|182945331|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 2||||.28
91533982|NCT01257503|182945331|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 3||||.26
91533983|NCT01257503|182945331|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status at follow-up||||.88
91533984|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 1||||.02
91757117|NCT02914561|183407156|SUPERIORITY||Stratified Percentage Difference|6.9||||0.0963|TWO_SIDED|95.0|-1.4|15.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||15.2|-1.4|0.0963
91757118|NCT02914561|183407156|SUPERIORITY||Stratified Percentage Difference|4.2||||0.305|TWO_SIDED|95.0|-3.9|12.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.2|-3.9|0.3050
91757119|NCT02914561|183407156|SUPERIORITY||Stratified Percentage Difference|11.9||||0.0039|TWO_SIDED|95.0|3.7|20.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.2|3.7|0.0039
91757120|NCT02914561|183407156|SUPERIORITY||Stratified Percentage Difference|1.1||||0.7556|TWO_SIDED|95.0|-6.2|8.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.5|-6.2|0.7556
91757121|NCT02914561|183407157|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0074|TWO_SIDED|95.0|3.2|20.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||20.8|3.2|0.0074
91757122|NCT02914561|183407157|SUPERIORITY||Stratified Percentage Difference|5.5||||0.2159|TWO_SIDED|95.0|-3.2|14.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||14.1|-3.2|0.2159
91757123|NCT02914561|183407157|SUPERIORITY||Stratified Percentage Difference|11.6||||0.011|TWO_SIDED|95.0|2.6|20.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.6|2.6|0.0110
91757124|NCT02914561|183407157|SUPERIORITY||Stratified Percentage Difference|8.2||||0.0593|TWO_SIDED|95.0|-0.4|16.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||16.7|-0.4|0.0593
91757125|NCT02914561|183407158|SUPERIORITY||Stratified Percentage Difference|16.8||||0.0382|TWO_SIDED|95.0|2.0|31.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||31.6|2.0|0.0382
91533985|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 2||||.01
91533986|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||day 2 assessment 1||||.25
91533987|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 2 assessment 2||||.15
91533988|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 1||||.88
91533989|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 2||||.35
91533990|NCT01257503|182945332|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score at 7-10 day follow-up||||.36
91533991|NCT02359435|182945343|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.016|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91533992|NCT01492309|182945349|SUPERIORITY|||||||0.003|||||||Fisher Exact|||This analysis is based on a mixed model that can handle missing data.||||0.003
91533993|NCT01492309|182945350|SUPERIORITY|||||||0.425|||||||Regression, Logistic|||This analysis is based on a mixed model that can handle missing data.||||0.425
91533994|NCT00711646|182945353|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.517||||0.048|TWO_SIDED|95.0|-1.029|-0.004|||ANCOVA|||The change in mean 11-point Numerical Rating Scale spasticity score was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline 11-point Numerical Rating Scale spasticity score as a covariate.||-0.004|-1.029|0.048
91533995|NCT00711646|182945354|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.218|TWO_SIDED|95.0|-0.29|0.07|||ANCOVA|||The change in mean Ashworth Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Ashworth Scale score as a covariate.||0.07|-0.29|0.218
91533996|NCT00711646|182945355|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.17||||0.141|TWO_SIDED|95.0|-0.39|0.06|||ANCOVA|||The change in mean spasm frequency score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline spasm frequency score as a covariate.||0.06|-0.39|0.141
91533997|NCT00711646|182945356|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.3||||0.766|TWO_SIDED|95.0|-7.47|10.07|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||10.07|-7.47|0.766
91533998|NCT00711646|182945357|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|8.46||||0.349|TWO_SIDED|95.0|-6.74|23.66|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||23.66|-6.74|0.349
91533999|NCT00711646|182945359|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.86||||0.054|TWO_SIDED|95.0|-0.06|7.78|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||7.78|-0.06|0.054
91534000|NCT01360840|182945370|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||||TWO_SIDED|95.0|0.57|1.39||||||||1.39|0.57|
91534001|NCT01360840|182945370|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.26||||||||1.26|0.52|
91534002|NCT01360840|182945371|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.52|2.31||||||||2.31|0.52|
91534003|NCT01360840|182945371|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.47|2.15||||||||2.15|0.47|
91534004|NCT01360840|182945372|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91|||||TWO_SIDED|95.0|0.58|1.44||||||||1.44|0.58|
91534005|NCT01360840|182945372|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.27||||||||1.27|0.52|
91534006|NCT05780047|182945472|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91534007|NCT05780047|182945473|OTHER||||||<|0.05|||||||paired samples t-test|||Paired samples t-tests were run to compare whether EHL knowledge, attitudes and behavior changed after the intervention. EHL scores were expected to increase between pre and post testing.||||<0.05
91534008|NCT00615433|182945487|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni's procedure for controlling pairwise differences.||||<0.05
91534009|NCT00615433|182945488|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
91534010|NCT03194776|182945490|SUPERIORITY||Mean Difference (Final Values)|-17.74|||=|0.2612|TWO_SIDED|80.0|-38.03|2.55||P-value of \<= 0.2 was considered significant.|two-sided test|||Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.||2.55|-38.03|= 0.2612
91534011|NCT00764868|182945500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
91534012|NCT00764868|182945502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
91535621|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.14|STANDARD_ERROR_OF_MEAN|2.44|<|0.0001|TWO_SIDED|95.0|-14.96|-5.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.32|-14.96|<0.0001
91534013|NCT00783692|182945503|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.8||||0.0206|TWO_SIDED|95.0|1.2|14.3||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||14.3|1.2|0.0206
91534014|NCT00783692|182945504|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.7||||0.2322|TWO_SIDED|95.0|-3.6|15.0||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||15.0|-3.6|0.2322
91534015|NCT00783692|182945505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.5||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||27.5|7.3|0.0007
91534016|NCT00783692|182945505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.7||||0.0042|TWO_SIDED|95.0|4.6|24.7||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||24.7|4.6|0.0042
91534017|NCT00783692|182945506|SUPERIORITY_OR_OTHER|||||||0.9288||||||Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).|Wilcoxon (Mann-Whitney)|||If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.||||0.9288
91534018|NCT00783692|182945507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.0132|TWO_SIDED|95.0|2.8|24.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||24.0|2.8|0.0132
91757126|NCT02914561|183407158|SUPERIORITY||Stratified Percentage Difference|5.8||||0.4263|TWO_SIDED|95.0|-8.5|20.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||20.0|-8.5|0.4263
91757127|NCT02914561|183407159|SUPERIORITY||Stratified Percentage Difference|10.9||||0.1827|TWO_SIDED|95.0|-4.7|26.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||26.4|-4.7|0.1827
91757128|NCT02914561|183407159|SUPERIORITY||Stratified Percentage Difference|4.0||||0.5944|TWO_SIDED|95.0|-11.1|19.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||19.2|-11.1|0.5944
91757129|NCT02914561|183407160|SUPERIORITY||Stratified Percentage Difference|15.2||||0.0512|TWO_SIDED|95.0|1.0|29.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||29.3|1.0|0.0512
91534019|NCT00783692|182945507|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0053|TWO_SIDED|95.0|4.6|26.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||26.0|4.6|0.0053
91534020|NCT00783692|182945508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.9||||0.0154|TWO_SIDED|95.0|3.0|28.7||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||28.7|3.0|0.0154
91534021|NCT00783692|182945508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.9||||0.045|TWO_SIDED|95.0|0.3|25.5||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||25.5|0.3|0.0450
91534022|NCT00783692|182945509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2||||0.1036|TWO_SIDED|95.0|-1.5|16.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||16.0|-1.5|0.1036
91534023|NCT00783692|182945509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.0||||0.6413|TWO_SIDED|95.0|-6.3|10.2||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||10.2|-6.3|0.6413
91534024|NCT04438785|182945529|SUPERIORITY||Mean Difference (Final Values)|2.58|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the Apnea Hypopnea Index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||<0.001
91534025|NCT04438785|182945530|SUPERIORITY||Median Difference (Final Values)|-0.971||||0.003|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the O2 desaturation index (ODI) from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.003
91534026|NCT04438785|182945531|SUPERIORITY||Mean Difference (Net)|-0.364||||0.001|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the IOPI tongue score from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
91757130|NCT02914561|183407160|SUPERIORITY||Stratified Percentage Difference|-0.2||||0.9801|TWO_SIDED|95.0|-13.3|13.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||13.0|-13.3|0.9801
91757131|NCT02914561|183407161|SUPERIORITY||Stratified Percentage Difference|14.0||||0.19|TWO_SIDED|95.0|-5.1|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||33.1|-5.1|0.1900
91534027|NCT04438785|182945532|SUPERIORITY||Median Difference (Final Values)|-1.131||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the IOPI lip score from the baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
91534028|NCT04438785|182945533|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the neck circumference from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
91534029|NCT04438785|182945534|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the waist circumference from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
91534030|NCT04438785|182945535|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.98|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the BMI from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.98
91534031|NCT04438785|182945536|SUPERIORITY||Median Difference (Final Values)|-1.23||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the Epworth Sleepiness Scale from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
91757132|NCT02914561|183407161|SUPERIORITY||Stratified Percentage Difference|-5.5||||0.4248|TWO_SIDED|95.0|-22.6|11.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||11.6|-22.6|0.4248
91757133|NCT02914561|183407162|SUPERIORITY||Stratified Percentage Difference|19.9||||0.0122|TWO_SIDED|95.0|5.7|34.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||34.0|5.7|0.0122
91757134|NCT02914561|183407162|SUPERIORITY||Stratified Percentage Difference|2.0||||0.7708|TWO_SIDED|95.0|-12.0|16.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||16.1|-12.0|0.7708
91757135|NCT02914561|183407163|SUPERIORITY||Stratified Percentage Difference|12.0||||0.2631|TWO_SIDED|95.0|-8.3|32.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||32.3|-8.3|0.2631
91757136|NCT02914561|183407163|SUPERIORITY||Stratified Percentage Difference|-3.4||||0.6444|TWO_SIDED|95.0|-20.9|14.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||14.0|-20.9|0.6444
91757137|NCT01300455|183407172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||||TWO_SIDED|90.0|0.22|5.09|||Difference of the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||5.09|0.22|
91757138|NCT01300455|183407175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|90.0|-0.49|0.42|||Difference in the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||0.42|-0.49|
91757139|NCT01300455|183407175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.45|0.33|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||0.33|-0.45|
91757140|NCT01300455|183407176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|90.0|-1.31|2.79|||Difference in the Least Squares Means|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||2.79|-1.31|
91534032|NCT04438785|182945537|SUPERIORITY||Mean Difference (Net)|0.98||||0.22|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Evaluate if the Pittsburgh sleep quality index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.22
91534033|NCT00689104|182945548|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41||||0.003|TWO_SIDED|95.0|-0.72|-0.09||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.09|-0.72|0.003
91535625|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.2||95.0|-0.04|0.2||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.20|-0.04|0.2000
91757141|NCT01300455|183407176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.1|0.59|||Difference in the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.59|-0.10|
91757142|NCT01300455|183407176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.59|1.01|||Difference in the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||1.01|-0.59|
91757143|NCT01300455|183407176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.09|0.65|||Difference in the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.65|-0.09|
91534034|NCT00689104|182945548|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29||||0.01|TWO_SIDED|95.0|-0.61|0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||0.03|-0.61|0.010
91534035|NCT00689104|182945548|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.11|TWO_SIDED|95.0|-0.42|0.21||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.21|-0.42|0.11
91534036|NCT00689104|182945549|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.29||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.29|-0.90|<0.001
91534037|NCT00689104|182945549|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44||||0.005|TWO_SIDED|95.0|-0.74|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.74|0.005
91534038|NCT00689104|182945549|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25||||0.11|TWO_SIDED|95.0|-0.55|0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.06|-0.55|0.11
91534039|NCT00689104|182945550|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.9|||<|0.001|TWO_SIDED|95.0|6.3|17.4||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.4|6.3|<0.001
91534040|NCT00689104|182945550|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|13.2|||<|0.001|TWO_SIDED|95.0|7.7|18.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.7|7.7|<0.001
91757144|NCT01300455|183407177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.61|0.49|||Difference of Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.49|-0.61|
91757145|NCT01300455|183407177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.41|0.5|||Difference of the Least Sqares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.41|
91534041|NCT00689104|182945550|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.6|||<|0.001|TWO_SIDED|95.0|7.1|18.2||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||18.2|7.1|<0.001
91757146|NCT01300455|183407177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.13|0.1|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.10|-1.13|
91757147|NCT01300455|183407177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.24|0.5|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.24|
91757148|NCT01300455|183407177|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02|||||TWO_SIDED|90.0|-0.4|0.43|||Difference in the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.43|-0.40|
91757149|NCT01300455|183407177|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.61|0.25|||Difference in the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.25|-0.61|
91757150|NCT01300455|183407178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|90.0|-3.2|2.26|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||2.26|-3.20|
91757151|NCT00651625|183407198|SUPERIORITY_OR_OTHER||non-applicable|||||0.05|TWO_SIDED||||||t-test, 2 sided|||group comparisons using t-test and confidence intervals.||||0.05
91511381|NCT01559311|182894354|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||"* H03: μ LVEF, 1= μ LVEF, 2b vs H1a: μ LVEF, 1 \< μ LVEF, 2b~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2b is the mean of LVEF at month 12 in the CRT-P OFF Gp"||||0.1439
91511382|NCT01559311|182894355|SUPERIORITY_OR_OTHER|||||||0.6276|||||||Wilcoxon (Mann-Whitney)|||"* H02: μ LVESV, 1 = μ LVESV, 2a vs H1b: μ LVESV, 1 \> μ LVESV, 2a~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* μLVESV, 2a is the mean of LVESV at month 12 in the CRT-P ON group"||||0.6276
91511383|NCT01559311|182894355|SUPERIORITY_OR_OTHER|||||||0.5871|||||||Wilcoxon (Mann-Whitney)|||"* H04: μ LVESV, 1 = μ LVESV, 2b vs H1b: μ LVESV, 1 \> μ LVESV, 2b~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* and μLVESV, 2b is the mean of LVESV at month 12 in CRT-P OFF group."||||0.5871
91511384|NCT00829621|182894398|SUPERIORITY_OR_OTHER||||||=|0.36|||||||t-test, 1 sided|||||||=0.36
91511385|NCT01856140|182894399|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.52
91511386|NCT01856140|182894399|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.47
91511387|NCT01856140|182894399|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.52
91511388|NCT01856140|182894400|OTHER|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.227
91511389|NCT01856140|182894400|OTHER|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.573
91511390|NCT01856140|182894400|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||||||0.588
91511391|NCT01856140|182894401|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.262
91511392|NCT01856140|182894401|OTHER|||||||0.631|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.631
91511393|NCT01856140|182894401|OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.796
91511394|NCT01856140|182894402|OTHER|||||||0.337|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.337
91511395|NCT01856140|182894402|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks||||0.078
91511396|NCT01856140|182894402|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.439
91511397|NCT03143829|182894437|OTHER|||||||0.083|||||||t-test, 2 sided|||Differences at week 10||||0.083
91511398|NCT03143829|182894438|OTHER|||||||0.099|||||||t-test, 2 sided|||Descriptive comparison||||.099
91511399|NCT03143829|182894439|OTHER|||||||0.558|||||||t-test, 2 sided|||comparison at time 4||||.558
91511400|NCT03143829|182894440|OTHER|||||||0.153|||||||Chi-squared|||descriptive comparison of resource use||||.153
91511401|NCT00672477|182894441|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
91511402|NCT00672477|182894442|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||< 0.0001
91757152|NCT04583956|183407269|SUPERIORITY||Odds Ratio (OR)|0.98||||0.927|TWO_SIDED|95.0|0.59|1.61|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while participants lost to follow-up after discharge to home are assigned a score of 2.||1.61|0.59|0.927
91757153|NCT04583956|183407270|SUPERIORITY||Odds Ratio (OR)|0.9||||0.829|TWO_SIDED|95.0|0.36|2.25|||Regression, Logistic||Odds ratio greater than 1 favors Remdesivir plus Risankizumab.|Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).||2.25|0.36|0.829
91757154|NCT04583956|183407271|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.399|TWO_SIDED|95.0|0.84|1.56|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.56|0.84|0.399
91757155|NCT04583956|183407272|SUPERIORITY||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.62|1.71|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.71|0.62|0.910
91757156|NCT04583956|183407273|SUPERIORITY||Odds Ratio (OR)|1.14||||0.617|TWO_SIDED|95.0|0.68|1.93|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.93|0.68|0.617
91757157|NCT04583956|183407306|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.46|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.46|0.82|0.550
91757158|NCT04583956|183407307|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.523|TWO_SIDED|95.0|0.82|1.48|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.48|0.82|0.523
91511403|NCT00924950|182894491|SUPERIORITY||Mean Difference (Final Values)|0.8571||||0.0008|TWO_SIDED||||||t-test, 2 sided|||||||0.0008
91757159|NCT01370265|183407310|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.||||0.14
91757160|NCT01370265|183407312|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05||||0.21
91511404|NCT01602315|182894496|SUPERIORITY_OR_OTHER_LEGACY||median HR|0.99||||||||||||||The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.||||
91511405|NCT01602315|182894496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.643|TWO_SIDED|95.0|0.69|1.82|||Regression, Cox|||||1.82|0.69|0.643
91534042|NCT00689104|182945551|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.71|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.71|0.002
91534043|NCT00689104|182945551|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38||||0.002|TWO_SIDED|95.0|-0.71|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.71|0.002
91757161|NCT01370265|183407313|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.||||0.57
91757162|NCT01370265|183407313|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.||||0.13
91757163|NCT01370265|183407313|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.||||0.44
91757164|NCT01370265|183407313|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.||||0.74
91757165|NCT01370265|183407314|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.||||0.78
91511406|NCT01602315|182894496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from central data \[SLD (C)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||0.97|0.30|0.039
91511407|NCT01602315|182894499|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier method (median)|43.0|||||TWO_SIDED|95.0|27.0|88.0|||||days|||88.0|27.0|
91511408|NCT01602315|182894505|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.313|TWO_SIDED|95.0|0.79|2.05|||Regression, Cox|||||2.05|0.79|0.313
91511409|NCT01602315|182894506|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier (median)|294.0|||||TWO_SIDED|95.0|172.0|463.0||||||||463.0|172.0|
91511410|NCT01602315|182894520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.235|TWO_SIDED|95.0|0.49|1.19|||Regression, Cox|||||1.19|0.49|0.235
91511411|NCT01602315|182894520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.062|TWO_SIDED|95.0|0.4|1.02|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from local data \[SLD (L)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||1.02|0.4|0.062
91511412|NCT02057757|182894581|EQUIVALENCE|The equivalence margin is 1.25 Days.||||||0.5634|||||||Fay - Shaw|||||||0.5634
91511413|NCT02057757|182894582|SUPERIORITY|||||||0.645||||||The p-value for each time point was calculated; Day 3|Fay - Shaw|||||||0.645
91511414|NCT02057757|182894582|SUPERIORITY|||||||0.989||||||The p-value for each value was calculated (Day 7).|Fay-Shaw|||||||0.989
91511415|NCT02057757|182894582|SUPERIORITY|||||||0.809||||||Day 14|Fay-Shaw|||||||0.809
91511416|NCT02057757|182894582|SUPERIORITY|||||||0.671||||||Day 28|Fay-Shaw|||||||0.671
91511417|NCT02057757|182894584|SUPERIORITY|||||||0.4277||||||Cough|Fay - Shaw|||||||0.4277
91511418|NCT02057757|182894584|SUPERIORITY|||||||0.4022||||||Sore Throat|Fay-Shaw|||||||0.4022
91511419|NCT02057757|182894584|SUPERIORITY|||||||0.5957||||||Fatigue|Fay-Shaw|||||||0.5957
91511420|NCT02057757|182894584|SUPERIORITY|||||||0.0446||||||Nasal Discharge|Fay-Shaw|||||||0.0446
91511421|NCT02057757|182894584|SUPERIORITY|||||||0.8628||||||Difficulty Breathing|Fay-Shaw|||||||0.8628
91511422|NCT02057757|182894584|SUPERIORITY|||||||0.16||||||Headache|Fay-Shaw|||||||0.16
91511423|NCT02057757|182894584|SUPERIORITY|||||||0.1234||||||Muscle Pain|Fay-Shaw|||||||0.1234
91511424|NCT02057757|182894584|SUPERIORITY|||||||0.2155||||||Nausea|Fay-Shaw|||||||0.2155
91511425|NCT02057757|182894584|SUPERIORITY|||||||0.5176||||||Vomiting|Fay-Shaw|||||||0.5176
91511426|NCT02057757|182894584|SUPERIORITY|||||||0.6986||||||Diarrhea|Fay-Shaw|||||||0.6986
91511427|NCT02057757|182894585|SUPERIORITY|||||||0.985|||||||Fay - Shaw|||||||0.9850
91511428|NCT02057757|182894586|SUPERIORITY|||||||0.681||||||Any Time|Fay - Shaw|||||||0.681
91511429|NCT02057757|182894586|SUPERIORITY|||||||0.341||||||Day 0|Fay-Shaw|||||||0.341
91757166|NCT01370265|183407314|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05||||0.42
91511430|NCT02057757|182894586|SUPERIORITY|||||||0.321||||||Day 3|Fay-Shaw|||||||0.321
91511431|NCT02057757|182894586|SUPERIORITY|||||||0.957||||||Day 7|Fay-Shaw|||||||0.957
91511432|NCT02057757|182894586|SUPERIORITY|||||||0.788||||||Day 14|Fay-Shaw|||||||0.788
91511433|NCT02057757|182894586|SUPERIORITY|||||||0.544||||||Day 28|Fay-Shaw|||||||0.544
91511434|NCT02057757|182894587|SUPERIORITY|||||||0.671||||||Any Time|Fay - Shaw|||||||0.671
91511435|NCT02057757|182894587|SUPERIORITY|||||||0.325||||||Day 0|Fay-Shaw|||||||0.325
91511436|NCT02057757|182894587|SUPERIORITY|||||||0.987||||||Day 3|Fay-Shaw|||||||0.987
91511437|NCT02057757|182894587|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
91511438|NCT02057757|182894587|SUPERIORITY|||||||0.311||||||Day 14|Fay-Shaw|||||||0.311
91511439|NCT02057757|182894588|SUPERIORITY|||||||0.973||||||Any Time|Fay - Shaw|||||||0.973
91511440|NCT02057757|182894588|SUPERIORITY|||||||0.575||||||Day 0|Fay-Shaw|||||||0.575
91511441|NCT02057757|182894588|SUPERIORITY|||||||0.548||||||Day 3|Fay-Shaw|||||||0.548
91511442|NCT02057757|182894588|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
91511443|NCT02057757|182894588|SUPERIORITY|||||||0.987||||||Day 14|Fay-Shaw|||||||0.987
91511444|NCT02057757|182894588|SUPERIORITY|||||||0.987||||||Day 28|Fay-Shaw|||||||0.987
91511445|NCT02057757|182894589|SUPERIORITY|||||||0.928||||||Pneumonia|Fay - Shaw|||||||0.928
91511446|NCT02057757|182894589|SUPERIORITY|||||||0.9669||||||ARDS|Fay-Shaw|||||||0.9669
91511447|NCT02057757|182894589|SUPERIORITY|||||||0.0832||||||Bronchitis|Fay-Shaw|||||||0.0832
91511448|NCT02057757|182894590|SUPERIORITY|||||||0.036||||||Adults (\>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?|Fay - Shaw|||||||0.0360
91511449|NCT02057757|182894590|SUPERIORITY|||||||0.038||||||Adults (\>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?|Fay-Shaw|||||||0.0380
91511450|NCT02057757|182894590|SUPERIORITY|||||||0.5035||||||Children (\< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?|Fay-Shaw|||||||0.5035
91511451|NCT02057757|182894590|SUPERIORITY|||||||0.9231||||||Children (\<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?|Fay-Shaw|||||||0.9231
91511452|NCT02057757|182894594|SUPERIORITY|||||||0.9785||||||No Detectable Virus on Day 3|Fay-Shaw|||||||0.9785
91511453|NCT01416194|182894617|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
91511454|NCT01416194|182894617|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.91|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.2|0.4|0.91
91511455|NCT01416194|182894618|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
91511456|NCT01416194|182894618|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.5|2.4|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.4|0.5|0.76
91511457|NCT01416194|182894619|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.3|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.3|0.01
91757167|NCT01370265|183407314|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05||||0.96
91757168|NCT01370265|183407314|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.||||0.13
91757169|NCT01370265|183407315|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.||||0.28
91757170|NCT01370265|183407315|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.||||0.51
91511458|NCT01416194|182894619|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.37|TWO_SIDED|95.0|0.4|1.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.4|0.37
91511459|NCT01416194|182894620|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.5|0.10
91511460|NCT01416194|182894620|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.19|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.2|0.4|0.19
91511461|NCT01416194|182894621|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
91511462|NCT01416194|182894621|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.1|0.4|0.90
91511463|NCT01416194|182894622|SUPERIORITY||Hazard Ratio (HR)|1.9|||<|0.01|TWO_SIDED|95.0|1.4|2.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.5|1.4|<0.01
91511464|NCT01416194|182894622|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.7|0.74
91511465|NCT01416194|182894623|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.6|0.3|<0.01
91511466|NCT01416194|182894623|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.4|0.01
91757171|NCT01370265|183407316|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.||||0.31
91511467|NCT01416194|182894624|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.1|<0.01
91511468|NCT01416194|182894624|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.2|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.2|0.06
91511469|NCT01416194|182894625|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
91511470|NCT01416194|182894625|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.38|TWO_SIDED|95.0|0.5|1.4|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.4|0.5|0.38
91511471|NCT01416194|182894627|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.24|TWO_SIDED|95.0|0.9|1.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.9|0.24
91511472|NCT01416194|182894627|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.59|TWO_SIDED|95.0|0.8|1.6|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.6|0.8|0.59
91511473|NCT01416194|182894628|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.6|1.0|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.0|0.6|0.03
91757172|NCT01370265|183407316|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.||||0.08
91757173|NCT01115673|183407328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|469.37|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
91757174|NCT01115673|183407328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.09||||0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||0.001
91757175|NCT01115673|183407328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|367.28|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
91511474|NCT01416194|182894628|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.6|0.19
91511475|NCT01416194|182894629|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.2|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.2|<0.01
91511476|NCT01416194|182894629|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.24|TWO_SIDED|95.0|0.3|1.3|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.3|0.24
91511477|NCT00048724|182894630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.452||||0.1439||95.0|0.88|2.396|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.396|0.880|0.1439
91511478|NCT00048724|182894631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.007||95.0|1.13|2.166|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.166|1.130|0.0070
91511479|NCT02732847|182894648|OTHER|Chi square tests used to compared groups||||||0.924||||||A p-value of \< 0.05 was considered|Chi-squared|||||||0.924
91511480|NCT01163682|182894652|NON_INFERIORITY|"This tests determined the odds of an increase of greater than or equal to 2 points on the BPI-SF worst pain score, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.~Null Hypothesis: electro-acupucture does not prevent taxane-induced peripheral neuropathy"|Odds Ratio (OR)|1.16||||0.25|TWO_SIDED|95.0|0.9|1.5|||Regression, Logistic|||||1.50|0.90|0.25
91511481|NCT01163682|182894653|NON_INFERIORITY|This tests determined the odds of an increase of greater than or equal to 5 points on the FACT-NTX scale, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.|Odds Ratio (OR)|1.25||||0.09|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||||1.62|0.97|0.09
91511482|NCT00414050|182894662|NON_INFERIORITY_OR_EQUIVALENCE|Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was \>= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.|Ratio of geometric means|1.99|||||TWO_SIDED|95.0|1.69|2.35||||||Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.||2.35|1.69|
91511483|NCT00395044|182894664|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Mixed Models Analysis|||||||.029
91511484|NCT00515827|182894675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||95.0||||P-value is 2-sided and is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.546
91511485|NCT03254134|182894713|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.534|0.97||||||There was no formal hypothesis testing.|The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.970|0.534|
91511486|NCT03254134|182894714|SUPERIORITY||Hazard Ratio (HR)|0.549|||||TWO_SIDED|95.0|0.303|0.994||||||There was no formal hypothesis testing.|The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.994|0.303|
91511487|NCT01009099|182894718|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||ANCOVA|Co-variates included in the analysis were time walked on the constant workrate test at baseline and adherence (sessions completed/expected).||The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.||||0.63
91757176|NCT01115673|183407329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.7|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534044|NCT00689104|182945551|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.35||||0.019|TWO_SIDED|95.0|-0.68|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.03|-0.68|0.019
91534045|NCT00689104|182945552|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.004|TWO_SIDED|95.0|-0.66|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.66|0.004
91534046|NCT00689104|182945552|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.79|-0.26||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.26|-0.79|<0.001
91534047|NCT00689104|182945552|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.016|TWO_SIDED|95.0|-0.6|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.06|-0.60|0.016
91534048|NCT04873817|182945588|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
91534049|NCT00216320|182945590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<.001
91534050|NCT02081365|182945615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|0.74|3.55|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||3.55|.74|<0.05
91534051|NCT02081365|182945616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.05|TWO_SIDED|95.0|0.39|1.57|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.57|.39|<0.05
91757177|NCT01115673|183407329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.14||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
91534052|NCT02081365|182945617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.05|TWO_SIDED|95.0|0.61|1.85|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.85|.61|<0.05
91534053|NCT02081365|182945618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.05|TWO_SIDED|95.0|0.01|1.64|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.64|.01|<0.05
91534054|NCT01394991|182945619|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.248|TWO_SIDED|95.0|-0.051|0.016|||Chi-squared|||The primary hypothesis was that the group of participants receiving epoetin alfa QW and the group of participants receiving epoetin alfa TIW would have similar incidence rate of participants with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.||0.016|-0.051|0.248
91534055|NCT01394991|182945619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.254||95.0|0.18|1.58|||Regression, Logistic|||||1.58|0.18|0.254
91534056|NCT01394991|182945620|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.029||||0.08|TWO_SIDED|95.0|-0.065|0.007|||Chi-squared|||||0.007|-0.065|0.08
91534057|NCT01394991|182945621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.073|TWO_SIDED|95.0|0.14|1.13|||Log Rank|The stratified log-rank test accounting for ECOG performance status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model with covariates for treatment group and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2) was used for estimates of hazard ratio and its 95% confidence interval.|||1.13|0.14|0.073
91534058|NCT01394991|182945622|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.039||||0.059||95.0|-0.083|0.005|||Chi-squared|||||0.005|-0.083|0.059
91534059|NCT01394991|182945623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.054|TWO_SIDED|95.0|0.21|1.03|||Log Rank|The stratified log-rank test accounting for ECOG score status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model including covariates for treatment group and the Eastern Cooperative Oncology Group (ECOG) score status (0 or 1 versus 2) was used for estimates of a hazard ratio and its 95% confidence interval.|||1.03|0.21|0.054
91534060|NCT01394991|182945624|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0041||||0.88||95.0|-0.0526|0.0608|||Chi-squared|||||0.0608|-0.0526|0.88
91534061|NCT01394991|182945625|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.514|TWO_SIDED|95.0|-0.056|0.108|||Chi-squared|||||0.108|-0.056|0.514
91757178|NCT01115673|183407329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|178.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757179|NCT01115673|183407330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|242.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757180|NCT01115673|183407330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.95||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91534062|NCT01394991|182945626|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.92|TWO_SIDED|95.0|-0.071|0.065|||Chi-squared|||||0.065|-0.071|0.920
91534063|NCT02337361|182945628|OTHER||||||||||||||||||Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||
91534064|NCT02337361|182945628|OTHER||||||||||||||||||Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation|||
91534065|NCT02337361|182945629|OTHER||Odds Ratio (OR)|0.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.01
91534066|NCT02337361|182945630|OTHER||Odds Ratio (OR)|0.23|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up|||||<.05
91534067|NCT02337361|182945631|OTHER||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.10
91534068|NCT02337361|182945632|OTHER||Odds Ratio (OR)|0.26|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up|||||<.01
91534069|NCT02337361|182945633|OTHER||||||||||||||||||Generalized estimating equations (GEE) tested DrinkWise's effects on changes in depression over time controlling for demographic differences between study condition and study sites.|||
91534070|NCT02427646|182945643|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|||||||<0.05
91534071|NCT02427646|182945644|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|a log-transformation ofthe RMS datasets was applied for statistical analysis||||||<0.05
91534072|NCT03824236|182945658|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (P-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|52.0||||0.003|TWO_SIDED|95.0|28.0|68.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between P-Fx group and the Infectivity Control group.||68|28|0.003
91534073|NCT03824236|182945658|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (NP-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|54.0||||0.002|TWO_SIDED|95.0|29.0|70.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between NP-Fx group and the Infectivity Control group.||70|29|0.002
91757181|NCT01115673|183407330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|188.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534074|NCT01641861|182945669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|7.3||||||||7.3|0.1|
91534075|NCT01641861|182945670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|12.8||||||||12.8|0.9|
91534076|NCT01641861|182945672|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
91534077|NCT01641861|182945673|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
91534078|NCT03230006|182945708|SUPERIORITY||Partial eta squared|0.152||||0.002|TWO_SIDED|95.0|||||ANOVA||A two-way mixed ANOVA was conducted to investigate treatment group differences in change in mean number of drinks consumed from baseline to post-treatment, as indicated by the Time by Treatment Condition interaction effect.|||||0.002
91534079|NCT03230006|182945708|SUPERIORITY||Partial eta squared|0.342|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA||This is the partial eta squared for the main effect of time.|||||<.001
91534080|NCT03230006|182945708|SUPERIORITY||Partial eta squared|0.018||||0.309|TWO_SIDED|95.0|||||ANOVA||This is the partial eta squared for the main effect of treatment condition.|||||.309
91534081|NCT03230006|182945708|OTHER||F|38.92|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||<.001
91534082|NCT03230006|182945708|OTHER||F|5.43||||0.03|TWO_SIDED|95.0|||||ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||.030
91511488|NCT02188485|182894727|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.72||0.278|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Thwarted belonging (INQ-TB) at 10 week follow-up||||.278
91757182|NCT01115673|183407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.037||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.037
91757183|NCT01115673|183407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.294||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.294
91757184|NCT01115673|183407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.006||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
91511489|NCT02188485|182894727|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.591|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Perceived burden (INQ-PB) at 10-week follow-up||||.591
91511490|NCT02188485|182894728|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.52||0.511|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.511
91511491|NCT02188485|182894729|SUPERIORITY||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|0.85||0.014|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.014
91511492|NCT00799617|182894730|SUPERIORITY||Mean Difference (Net)|0.58|||<|0.001|TWO_SIDED|95.0|0.38|0.78||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||0.78|0.38|<0.001
91511493|NCT00799617|182894731|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2|TWO_SIDED|95.0|0.83|2.45||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.||2.45|0.83|0.20
91511494|NCT00799617|182894732|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3|TWO_SIDED|95.0|0.83|1.84||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||1.84|0.83|0.30
91511495|NCT00799617|182894733|SUPERIORITY||Mean Difference (Final Values)|41.0||||0.003|TWO_SIDED|95.0|14.0|67.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||67|14|.003
91511496|NCT00799617|182894734|SUPERIORITY||Mean Difference (Final Values)|6.8|||<|0.001|TWO_SIDED|95.0|4.8|8.7||Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.|Regression, Linear|||||8.7|4.8|<.001
91511497|NCT00799617|182894735|SUPERIORITY||Mean Difference (Net)|-0.07||||0.88|TWO_SIDED|95.0|-0.92|0.79||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis|||"A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.~The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors."||0.79|-0.92|.88
91511498|NCT00799617|182894736|SUPERIORITY|Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.|Odds Ratio (OR)|31.5||||0.002|TWO_SIDED|95.0|3.7|277.8||The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.|Mixed Models Analysis|The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.||||277.8|3.7|.002
91511499|NCT00799617|182894737|SUPERIORITY||Mean Difference (Net)|2.93|||<|0.001|TWO_SIDED|95.0|2.13|3.74||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.74|2.13|<0.001
91511500|NCT00799617|182894738|SUPERIORITY||Median Difference (Net)|2.64|||<|0.001|TWO_SIDED|95.0|1.68|3.61||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.61|1.68|<0.001
91511501|NCT00799617|182894739|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.28|TWO_SIDED|95.0|-3.0|11.18||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||11.18|-3.00|0.28
91511502|NCT00799617|182894740|SUPERIORITY||Odds Ratio (OR)|1.34||||0.15|TWO_SIDED|95.0|0.9|2.0||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.00|0.90|0.15
91757185|NCT01115673|183407332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.85|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757186|NCT01115673|183407332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.946||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.946
91511503|NCT00799617|182894741|SUPERIORITY||Mean Difference (Net)|2.75||||0.03|TWO_SIDED|95.0|0.2|5.29||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||5.29|0.20|0.03
91511504|NCT00799617|182894742|SUPERIORITY||Mean Difference (Net)|1.21||||0.06|TWO_SIDED|95.0|-0.04|2.46||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.46|-0.04|0.06
91511505|NCT00799617|182894743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.03|TWO_SIDED|95.0|0.31|4.5||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||4.50|0.31|0.03
91511506|NCT00799617|182894744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||0.92|0.02|0.04
91511507|NCT00799617|182894745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.79|-0.19||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.19|-0.79|<0.001
91511508|NCT00799617|182894746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.004|TWO_SIDED|95.0|-1.2|-0.23||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.23|-1.20|0.004
91511509|NCT00799617|182894747|SUPERIORITY||Mean Difference (Final Values)|47.0||||0.006|TWO_SIDED|95.0|13.0|80.0||Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||80|13|.006
91511510|NCT00799617|182894748|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.31|TWO_SIDED|95.0|-80.0|26.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||26|-80|.31
91511511|NCT00799617|182894749|SUPERIORITY||Mean Difference (Final Values)|2.9|||<|0.001|TWO_SIDED|95.0|2.1|3.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||3.7|2.1|<.001
91511512|NCT00799617|182894750|SUPERIORITY||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|3.2|5.3||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||5.3|3.2|<.001
91511513|NCT00799617|182894751|SUPERIORITY||Median Difference (Final Values)|1.5|||<|0.001|TWO_SIDED|95.0|0.9|2.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.0|0.9|<.001
91757187|NCT01115673|183407332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757188|NCT01115673|183407333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91511514|NCT00799617|182894752|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.5||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.5|0.5|<.001
91511515|NCT00799617|182894753|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.7|||Regression, Linear|||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."||1.7|0.8|<.001
91511516|NCT00799617|182894754|SUPERIORITY||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.3|809.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||809|5.3|<.001
91534083|NCT03230006|182945708|OTHER||F|1.15||||0.016|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at baseline. For the UP, n=51; for the TC, n=24.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.016
91534084|NCT03230006|182945708|OTHER||F|7.78||||0.007|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at post-treatment. For the UP, n=38; for the TC, n=21.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.007
91534085|NCT00901485|182945808|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To test for non-inferiority, a sample size of 36 (18 patients completing both arms of the crossover) was calculated to provide 80% power to detect a 2.5% drop in the primary outcome, mean overnight oxygen saturation (SpO2), with a SD of 3% at a significance level of 0.05|Median Difference (Final Values)|0.4||||0.13|TWO_SIDED|95.0|-0.2|1.0||a priori threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||"We tested the hypothesis that iVAPS can ventilate a patient naive to NIV at least as effectively as standard PS.~Sleep and breathing parameters at the end of each treatment period were compared using Wilcoxon Signed Rank test. The median difference between treatments with 95% confidence intervals was then compared by related-samples Hodges-Lehman test"||1.0|-0.2|0.13
91534086|NCT00901485|182945809|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|PtcCO2 is compared as a secondary outcome resulting in CO2 elimination similar to that of standard PS ventilation (median difference (95% CI) of -0.04(- 0.03 to 0.4)kPa in mean overnight PtcCO2).|Median Difference (Final Values)|0.0||||0.54|TWO_SIDED|95.0|-0.3|0.4|||Wilcoxon (Mann-Whitney)|||Hypothesis: that we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non-inferior to standard pressure support (PS) ventilation, with settings determined by an experienced healthcare professional, for controlling nocturnal hypoventilation in patients naïve to NIV.||0.4|-0.3|0.54
91534087|NCT00901485|182945810|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-0.5|0.94
91534088|NCT00901485|182945811|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.42|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.42
91534089|NCT00901485|182945812|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.82||95.0|-8.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|-8|0.82
91534090|NCT00901485|182945813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|1.04||||0.0004|TWO_SIDED|95.0|0.27|1.44|||Wilcoxon (Mann-Whitney)|||||1.44|0.27|0.0004
91534091|NCT00901485|182945814|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Mean Difference (Net)|-0.2||||0.5|TWO_SIDED|95.0|-1.2|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-1.2|0.5
91534092|NCT00901485|182945815|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-2.2||||0.001|TWO_SIDED|95.0|-4.5|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-4.5|0.001
91757189|NCT01115673|183407333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.661||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.661
91534093|NCT00901485|182945816|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-10.0||||0.47|TWO_SIDED|95.0|-54.0|23.0|||Wilcoxon (Mann-Whitney)|||||23|-54|0.47
91534094|NCT00901485|182945817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.3||||0.41|TWO_SIDED|95.0|-0.7|2.2|||Wilcoxon (Mann-Whitney)|||||2.2|-0.7|0.41
91534095|NCT00901485|182945818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|4.0||||0.36|TWO_SIDED|95.0|-5.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-5|0.36
91534096|NCT00901485|182945819|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
91757190|NCT01115673|183407333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.62|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534097|NCT00901485|182945820|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
91534098|NCT00901485|182945821|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.72|TWO_SIDED|95.0|-9.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|-9|0.72
91534099|NCT02162446|182945849|OTHER|||||||0.016|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.016
91534100|NCT02162446|182945849|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
91534101|NCT02162446|182945849|OTHER|||||||0.012|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.012
91757191|NCT01115673|183407334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757192|NCT01115673|183407334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.13||95.0||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.13
91511517|NCT00799617|182894755|SUPERIORITY||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.0|10.9||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||10.9|6.0|<.001
91511518|NCT00799617|182894756|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.001|TWO_SIDED|95.0|4.3|7.2||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||7.2|4.3|<.001
91511519|NCT00799617|182894757|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.001|TWO_SIDED|95.0|1.1|2.6||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.6|1.1|<.001
91511520|NCT00799617|182894758|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.005|TWO_SIDED|95.0|0.3|1.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.7|0.3|.005
91511521|NCT00799617|182894759|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.4||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.4|0.5|<.001
91511522|NCT00799617|182894760|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.25|2.09||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.09|0.25|.01
91511523|NCT00799617|182894761|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.052|TWO_SIDED|95.0|-0.01|1.36||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.36|-0.01|.052
91511524|NCT00799617|182894762|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.27|TWO_SIDED|95.0|-0.45|1.58||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.58|-0.45|0.27
91511525|NCT00799617|182894763|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.24|TWO_SIDED|95.0|-0.76|0.19||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||0.19|-0.76|.24
91511526|NCT00799617|182894764|SUPERIORITY||Mean Difference (Net)|-0.12||||0.89|TWO_SIDED|95.0|-1.89|1.65||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.65|-1.89|.89
91511527|NCT00799617|182894765|SUPERIORITY||Mean Difference (Net)|-5.51||||0.14|TWO_SIDED|95.0|-12.91|1.88||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.88|-12.91|.14
91511528|NCT00799617|182894766|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.001|TWO_SIDED|95.0|0.48|1.39||The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.|Mixed Models Analysis||Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.|||1.39|0.48|<.001
91511529|NCT02442830|182894782|OTHER|Log rank test||||||0.002|||||||Log Rank|||||||.002
91511530|NCT03851016|182894803|SUPERIORITY|||||||0.113|||||||Mancova|||"Null hypothesis is that there would be no difference in change of depressive symptoms between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the GDS-12R at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in depressive symptoms."||||.113
91513560|NCT03029208|182898975|SUPERIORITY||LS mean difference|-6.43||||0.9875|TWO_SIDED|95.0|-12.05|-0.82|||MMRM||Tired/Low energy/Weak domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-0.82|-12.05|0.9875
91757193|NCT01115673|183407334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534102|NCT02162446|182945849|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
91534103|NCT02162446|182945849|OTHER|||||||0.5|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.500
91534104|NCT02162446|182945849|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
91757194|NCT01115673|183407335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757195|NCT01115673|183407335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.041||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.041
91757196|NCT01115673|183407335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757197|NCT01115673|183407336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757198|NCT01115673|183407336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34||||0.02||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.02
91757199|NCT01115673|183407336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.63|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757200|NCT01115673|183407337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.46|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757201|NCT01115673|183407337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.08||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
91757202|NCT01115673|183407337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.38|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757203|NCT01115673|183407338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757204|NCT01115673|183407338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.83||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91757205|NCT01115673|183407338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.59|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757206|NCT01115673|183407339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757207|NCT01115673|183407339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757208|NCT01115673|183407339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757209|NCT01115673|183407340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757210|NCT01115673|183407340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757211|NCT01115673|183407340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534105|NCT02162446|182945851|OTHER|||||||0.25|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.250
91534106|NCT02162446|182945851|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
91534107|NCT02162446|182945851|OTHER|||||||0.688|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.688
91757212|NCT01115673|183407341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757213|NCT01115673|183407341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91757214|NCT01115673|183407341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757215|NCT01115673|183407342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35||||0.028||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.028
91757216|NCT01115673|183407342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.462||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.462
91757217|NCT01115673|183407342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.008||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.008
91757218|NCT01115673|183407343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.81|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534108|NCT02162446|182945851|OTHER|||||||0.578|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.578
91534109|NCT02162446|182945852|OTHER|||||||0.027|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.027
91757219|NCT01115673|183407343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.907||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.907
91757220|NCT01115673|183407343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757221|NCT01115673|183407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.19|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757222|NCT01115673|183407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.655||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.655
91757223|NCT01115673|183407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757224|NCT01115673|183407345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.15|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757225|NCT01115673|183407345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.155||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.155
91757226|NCT01115673|183407345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534110|NCT02162446|182945852|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
91757227|NCT01115673|183407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.69|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757228|NCT01115673|183407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.04||||0.05||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.05
91757229|NCT01115673|183407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757230|NCT01115673|183407347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.83|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757231|NCT01115673|183407347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.74||||0.032||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.032
91757232|NCT01115673|183407347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757233|NCT01115673|183407348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.36|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757234|NCT01115673|183407348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.52||||0.003||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.003
91757235|NCT01115673|183407348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757236|NCT01115673|183407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757237|NCT01115673|183407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.04||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91757238|NCT01115673|183407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.75|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757239|NCT01115673|183407350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757240|NCT01115673|183407350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757241|NCT01115673|183407350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.02|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757242|NCT01115673|183407351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757243|NCT01115673|183407351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757244|NCT01115673|183407351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757245|NCT01115673|183407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757246|NCT01115673|183407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
91757247|NCT01115673|183407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757248|NCT01115673|183407353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65||||0.027||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.027
91757249|NCT01115673|183407353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49||||0.365||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.365
91757250|NCT01115673|183407353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14||||0.005||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.005
91757251|NCT01115673|183407354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757252|NCT01115673|183407354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.923||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.923
91757253|NCT01115673|183407354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91511531|NCT03851016|182894804|SUPERIORITY|||||||0.123|||||||Mancova|||"Null hypothesis is that there would be no difference in change of Presence of Meaning (POM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the POM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in POM."||||.123
91757254|NCT01115673|183407355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757255|NCT01115673|183407355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.653||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.653
91757256|NCT01115673|183407355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757257|NCT01115673|183407356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.71|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757258|NCT01115673|183407356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.21||||0.138||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.138
91757259|NCT01115673|183407356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757260|NCT01115673|183407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.66|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757261|NCT01115673|183407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.043||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.043
91757262|NCT01115673|183407357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82.2|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757263|NCT01115673|183407358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757264|NCT01115673|183407358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.08||||0.024||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.024
91757265|NCT01115673|183407358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757266|NCT01115673|183407359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757267|NCT01115673|183407359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91757268|NCT01115673|183407359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.23|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91511532|NCT03851016|182894805|SUPERIORITY|||||||0.91|||||||Mancova|||"The null hypothesis is that there would be no difference in change of Search for Meaning (SFM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the SFM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in SFM."||||.910
91511533|NCT02553746|182894817|SUPERIORITY|||||||0.748|||||||Chi-squared, Corrected|||||||0.748
91511534|NCT02553746|182894818|SUPERIORITY|||||||0.498|||||||Chi-squared, Corrected|||||||0.498
91511535|NCT02553746|182894819|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
91511536|NCT02553746|182894820|SUPERIORITY|||||||0.162|||||||Wilcoxon (Mann-Whitney)|||||||0.162
91511537|NCT02553746|182894821|SUPERIORITY|||||||0.104|||||||Chi-squared, Corrected|||||||0.104
91511538|NCT02553746|182894822|SUPERIORITY||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||||||<0.005
91511539|NCT01660412|182894860|OTHER||Mean Difference (Final Values)|1.42|STANDARD_DEVIATION|2.17|<|0.0001|TWO_SIDED|95.0|0.85|2.0|||t-test, 2 sided|||||2.00|0.85|<0.0001
91511540|NCT03328897|182894881|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|0.746|<|0.001|TWO_SIDED|95.0|-5.7|-2.77|||Mixed Model with Repeated Measures(MMRM)|||||-2.77|-5.70|<0.001
91511541|NCT03328897|182894881|SUPERIORITY||Mean Difference (Net)|-3.79|STANDARD_ERROR_OF_MEAN|0.738|<|0.001|TWO_SIDED|95.0|-5.24|-2.33|||Mixed Model with Repeated Measures(MMRM)|||||-2.33|-5.24|<0.001
91511542|NCT03328897|182894882|SUPERIORITY||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|1.555|<|0.001|TWO_SIDED|95.0|-13.25|-7.14|||Mixed Model with Repeated Measures(MMRM)|||||-7.14|-13.25|<0.001
91511543|NCT03328897|182894882|SUPERIORITY||Mean Difference (Net)|-9.12|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-12.14|-6.1|||Mixed Model with Repeated Measures(MMRM)|||||-6.10|-12.14|<0.001
91511544|NCT03328897|182894883|SUPERIORITY||Mean Difference (Net)|-5.92|STANDARD_ERROR_OF_MEAN|0.853|<|0.001|TWO_SIDED|95.0|-7.59|-4.24|||Mixed Model with Repeated Measures(MMRM)|||||-4.24|-7.59|<0.001
91511545|NCT03328897|182894883|SUPERIORITY||Mean Difference (Net)|-5.35|STANDARD_ERROR_OF_MEAN|0.842|<|0.001|TWO_SIDED|95.0|-7.0|-3.69|||Mixed Model with Repeated Measures(MMRM)|||||-3.69|-7.00|<0.001
91511546|NCT03328897|182894884|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.27|15.06|||Regression, Logistic|||||15.06|3.27|<0.001
91511547|NCT03328897|182894884|SUPERIORITY||Odds Ratio (OR)|7.03|||<|0.001|TWO_SIDED|95.0|3.29|15.06|||Regression, Logistic|||||15.06|3.29|<0.001
91511548|NCT03328897|182894885|SUPERIORITY||Odds Ratio (OR)|11.21|||<|0.001|TWO_SIDED|95.0|3.88|32.37|||Regression, Logistic|||||32.37|3.88|<0.001
91511549|NCT03328897|182894885|SUPERIORITY||Odds Ratio (OR)|5.88||||0.001|TWO_SIDED|95.0|2.01|17.17|||Regression, Logistic|||||17.17|2.01|0.001
91511550|NCT03328897|182894886|SUPERIORITY||Odds Ratio (OR)|2.73|||<|0.001|TWO_SIDED|95.0|1.51|4.95|||Regression, Logistic|||||4.95|1.51|<0.001
91511551|NCT03328897|182894886|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.41|4.56|||Regression, Logistic|||||4.56|1.41|0.002
91511552|NCT03328897|182894887|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.7|-2.3|||Mixed Model with Repeated Measures(MMRM)|||||-2.3|-5.7|<0.001
91511553|NCT03328897|182894887|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.1|-1.8|||Mixed Model with Repeated Measures(MMRM)|||||-1.8|-5.1|<0.001
91511554|NCT03328897|182894888|SUPERIORITY||Hazard Ratio (HR)|1.71|||<|0.001|TWO_SIDED|95.0|1.25|2.33|||Regression, Cox|||||2.33|1.25|<0.001
91511555|NCT03328897|182894888|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.001|TWO_SIDED|95.0|1.22|2.25|||Regression, Cox|||||2.25|1.22|0.001
91511556|NCT03223298|182894927|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||3-month mean change (from pre-op) in Jaw Pain compared between the Botox group and Placebo group.||||0.80
91511557|NCT03223298|182894928|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||3-month mean Jaw Function Limitation Scale score compared between Botox group and placebo group.||||0.50
91511558|NCT03223298|182894929|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Change in MIO with Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.30
91511559|NCT03223298|182894929|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Change in MIO without Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.50
91511560|NCT03223298|182894930|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mean change at 3 months post intervention - General Health Score, compared between Botox group and Placebo group.||||0.40
91511561|NCT01040871|182894954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.915|TWO_SIDED|95.0|0.529|2.037|||Cochran-Mantel-Haenszel|Stratified by IPI score|Odds ratio: VR-CAP CR rate relative to R-CHOP CR rate|||2.037|0.529|0.915
91511562|NCT01175824|182894981|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the upper limit of the 95% confidence interval (CI) of the difference in the LS mean between the two treatment arms (twice-daily insulin lispro Low Mixture minus the comparator arm) at 24 weeks is \<0.4%.|LS mean difference|-0.21|||||TWO_SIDED|95.0|-0.38|-0.04||||||||-0.04|-0.38|
91511563|NCT01175824|182894982|SUPERIORITY_OR_OTHER|||||||0.1858||95.0|||||Mixed Models Analysis|||||||0.1858
91511564|NCT01175824|182894983|SUPERIORITY_OR_OTHER|||||||0.3588||95.0||||HbA1c concentration \<7%|Fisher Exact|||||||0.3588
91511565|NCT01175824|182894983|SUPERIORITY_OR_OTHER|||||||0.5958||95.0||||HbA1c \<=6.5%|Fisher Exact|||||||0.5958
91511566|NCT01175824|182894984|SUPERIORITY_OR_OTHER|||||||0.0827||95.0||||p-value is for the Week 12 comparison|Mixed Models Analysis|||||||0.0827
91511567|NCT01175824|182894984|SUPERIORITY_OR_OTHER|||||||0.5353||95.0||||p-value is for the Week 24 comparison|Mixed Models Analysis|||||||0.5353
91511568|NCT01175824|182894988|SUPERIORITY_OR_OTHER|||||||0.2833||95.0||||p-value is for the comparison at Week 12.|Mixed Models Analysis|||||||0.2833
91511569|NCT01175824|182894988|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p-value is for the comparison at Week 24.|Mixed Models Analysis|||||||0.0176
91511570|NCT01175824|182894994|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|||||TWO_SIDED|95.0|-0.39|-0.05||||Superiority will be concluded if of 95% CI upper limit for treatment difference (2x-daily insulin lispro LM minus the comparator arm) at 24 wks is \<0%||||-0.05|-0.39|
91511571|NCT00982319|182894999|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91511572|NCT00767000|182895001|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51|||<|0.001||95.0|-0.8|-0.22|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.22|-0.80|<0.001
91511573|NCT00767000|182895001|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|||<|0.001||95.0|-0.93|-0.36|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.36|-0.93|<0.001
91511574|NCT00767000|182895001|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|||<|0.001||95.0|-1.1|-0.53|||Contrained longitudinal model|||Analysis for change from baseline to Week 14||-0.53|-1.10|<0.001
91511575|NCT00767000|182895001|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001||95.0|-1.04|-0.46|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.46|-1.04|<0.001
91511576|NCT00767000|182895002|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.6|||<|0.001||95.0|-55.6|-17.5|||Constrained longitudial model|||Analysis for change from baseline to Week 14||-17.5|-55.6|<0.001
91511577|NCT00767000|182895002|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-26.7||||0.005||95.0|-45.4|-8.1|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-8.1|-45.4|0.005
91534111|NCT02162446|182945853|OTHER|||||||0.064|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.064
91534112|NCT02162446|182945853|OTHER|||||||0.339|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.339
91534113|NCT02162446|182945853|OTHER|||||||0.001|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.001
91534114|NCT02162446|182945853|OTHER|||||||0|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.000
91534115|NCT02162446|182945853|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
91757269|NCT01115673|183407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534116|NCT02162446|182945853|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
91534117|NCT02162446|182945854|OTHER|||||||0.47|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.470
91534118|NCT02162446|182945854|OTHER|||||||0.233|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.233
91534119|NCT02162446|182945854|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
91534120|NCT02162446|182945855|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.004
91757270|NCT01115673|183407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91757271|NCT01115673|183407360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757272|NCT01115673|183407361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757273|NCT01115673|183407361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757274|NCT01115673|183407361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757275|NCT01115673|183407362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757276|NCT01115673|183407362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757277|NCT01115673|183407362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91534121|NCT02162446|182945855|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
91534122|NCT02162446|182945855|OTHER|||||||0.426|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.426
91534123|NCT02162446|182945855|OTHER|||||||0.098|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.098
91757278|NCT01115673|183407363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757279|NCT01115673|183407363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.98||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91757280|NCT01115673|183407363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.41|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757281|NCT01115673|183407364|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757282|NCT01115673|183407364|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.26
91757283|NCT01115673|183407364|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757284|NCT01115673|183407365|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757285|NCT01115673|183407365|SUPERIORITY_OR_OTHER|||||||0.934||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.934
91757286|NCT01115673|183407365|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757287|NCT01115673|183407366|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
91757288|NCT01115673|183407366|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
91757289|NCT01115673|183407366|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
91757290|NCT01115673|183407367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757291|NCT01115673|183407367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.002||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
91534124|NCT02162446|182945855|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.813
91757292|NCT01115673|183407367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757293|NCT01115673|183407368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757294|NCT01115673|183407368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757295|NCT01115673|183407368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757296|NCT01115673|183407369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757297|NCT01115673|183407369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.006||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
91757298|NCT01115673|183407369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.16|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757299|NCT01115673|183407370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757300|NCT01115673|183407370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
91757301|NCT01115673|183407370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91757302|NCT01959841|183407384|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(400mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||2.41e-06|||||||Modified Farrington-Manning test|||The non-inferiority of each ASP2151 dose level versus valaciclovir was assessed stepwise using a closed testing procedure.First step analysis was performed in the ASP2151(400mg) once daily.||||0.00000241
91511578|NCT00767000|182895002|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-35.0|||<|0.001||95.0|-54.0|-16.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-16.0|-54.0|<0.001
91511579|NCT00767000|182895002|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.9|||<|0.001||95.0|-55.9|-17.9|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-17.9|-55.9|<0.001
91511580|NCT00767000|182895003|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.8||||0.791||95.0|-11.6|15.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||15.2|-11.6|0.791
91511581|NCT00767000|182895003|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.3||||0.121||95.0|-2.7|23.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||23.2|-2.7|0.121
91511582|NCT00767000|182895003|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.3||||0.169||95.0|-22.6|4.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||4.0|-22.6|0.169
91511583|NCT00767000|182895003|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.7||||0.321||95.0|-6.6|20.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||20.0|-6.6|0.321
91511584|NCT00127790|182895008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.01|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.010
91511585|NCT00127790|182895008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.581|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.581
91511586|NCT00127790|182895008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.011|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.011
91511587|NCT00127790|182895009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.33|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.33
91511588|NCT00127790|182895009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.112|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.112
91511589|NCT00127790|182895009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.737|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.737
91511590|NCT00127790|182895010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.063|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.063
91511591|NCT00127790|182895010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.786|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.786
91511592|NCT00127790|182895010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.039|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.039
91511593|NCT00127790|182895011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.016|||||||Generlaized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.016
91511594|NCT00127790|182895011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4||||0.187|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.187
91511595|NCT00127790|182895011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2||||0.015|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.015
91511596|NCT00097591|182895025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.002|TWO_SIDED|95.0|0.726|0.927||The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.|Gehan-Wilcoxon|||For UA/NSTEMI population||0.927|0.726|0.002
91759897|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.58|||||TWO_SIDED|95.0|-17.48|0.33||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-17.48|
91757303|NCT01959841|183407384|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(200mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||0.0688|||||||Modified Farrington-Manning test|||The analysis was performed in the ASP2151(200 mg) once daily only when non-inferiority of the ASP2151(400 mg) 0nce daily to valaciclovir 1000 mg three times daily was assumed.||||0.0688
91757304|NCT01128192|183407399|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||Two sided P value|ANOVA|||Change in fasting plasma glucose level||||0.240
91757305|NCT01128192|183407399|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma glucose level||||0.339
91757306|NCT01128192|183407400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
91757307|NCT01128192|183407400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
91757308|NCT01128192|183407400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
91757309|NCT01128192|183407400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
91757310|NCT01128192|183407400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
91757311|NCT01128192|183407400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
91757312|NCT01128192|183407401|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||0.019
91511597|NCT00097591|182895025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.019|TWO_SIDED|95.0|0.649|0.968|||Gehan-Wilcoxon|||For STEMI population||0.968|0.649|0.019
91511598|NCT00097591|182895025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.812|||<|0.001|TWO_SIDED|95.0|0.732|0.902|||Gehan-Wilcoxon|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For All ACS population||0.902|0.732|<0.001
91511599|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.314||||0.002|TWO_SIDED|95.0|1.107|1.559|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major or Minor Bleeding||1.559|1.107|0.002
91511600|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.315||||0.029|TWO_SIDED|95.0|1.028|1.683|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major Bleeding||1.683|1.028|0.029
91757313|NCT01128192|183407401|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||<0.001
91757314|NCT01128192|183407402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
91757315|NCT01128192|183407402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
91757316|NCT01128192|183407402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
91757317|NCT01128192|183407402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
91757318|NCT01128192|183407402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
91757319|NCT01128192|183407402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
91757320|NCT01128192|183407403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Baseline Insulin Level||||<0.001
91757321|NCT01128192|183407403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Change in Baseline Insulin Level||||<0.001
91757322|NCT01128192|183407404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
91757323|NCT01128192|183407404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
91757324|NCT01128192|183407404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
91757325|NCT01128192|183407404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
91757326|NCT01128192|183407404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
91757327|NCT01128192|183407404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
91757328|NCT01128192|183407405|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.608
91757329|NCT01128192|183407405|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.132
91757330|NCT01128192|183407406|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.178
91757331|NCT01128192|183407406|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.111
91757332|NCT01128192|183407407|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in high-dose % EGP Inhibition||||0.573
91757333|NCT01128192|183407408|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.956
91757334|NCT01128192|183407408|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.125
91757335|NCT01128192|183407409|SUPERIORITY_OR_OTHER|||||||0.993|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.993
91757336|NCT01128192|183407409|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.956
91757337|NCT03121365|183407417|EQUIVALENCE|0.05||||||0.7635|TWO_SIDED|95.0|||||t-test, 2 sided|||Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.7635
91511601|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.517||||0.015|TWO_SIDED|95.0|1.083|2.126|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)||2.126|1.083|0.015
91757338|NCT03121365|183407417|EQUIVALENCE|0.05||||||0.0996|||||||t-test, 2 sided|||Language Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.0996
91757339|NCT03121365|183407417|EQUIVALENCE|0.05||||||0.2291|||||||t-test, 2 sided|||Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.2291
91757340|NCT03121365|183407418|EQUIVALENCE|0.05||||||0.018|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book arm||||.0180
91757341|NCT03121365|183407418|EQUIVALENCE|0.05||||||0.4144|||||||t-test, 2 sided|||StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book arm||||.4144
91757342|NCT03121365|183407418|EQUIVALENCE|0.05||||||0.4251|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm||||.4251
91757343|NCT03121365|183407419|SUPERIORITY|||||||0.235||||||Difference in Board Book Reading|Chi-squared|||||||0.235
91757344|NCT03121365|183407420|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91757345|NCT03121365|183407421|SUPERIORITY|||||||0.601|||||||Chi-squared|||||||0.601
91757346|NCT03121365|183407422|SUPERIORITY|||||||0.219|||||||Chi-squared|||||||0.219
91757347|NCT03121365|183407423|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91757348|NCT03121365|183407424|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||0.574
91757349|NCT03121365|183407425|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.430
91757350|NCT03121365|183407426|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91757351|NCT03121365|183407427|SUPERIORITY|||||||0.861|||||||Chi-squared|||||||0.861
91757352|NCT00655629|183407429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|||<|0.0001||95.0|-8.45|-5.38|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.38|-8.45|<0.0001
91757353|NCT00655629|183407430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.972|||<|0.0001||95.0|-32.688|-19.256|||ANCOVA|||Statistical analysis applies to the total population.||-19.256|-32.688|<0.0001
91757354|NCT00655629|183407431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.432|||<|0.0001||95.0|-40.439|-26.425|||ANCOVA|||Statistical analysis applies to the total population.||-26.425|-40.439|<0.0001
91511602|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.191||||0.002|TWO_SIDED|95.0|1.158|11.113|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Fatal||11.113|1.1580|0.002
91511603|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.119||||0.736|TWO_SIDED|95.0|0.582|2.152|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)||2.152|0.582|0.736
91757355|NCT00655629|183407432|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|53.8693|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
91757356|NCT00655629|183407433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.078|||<|0.0001||95.0|-22.41|-9.746|||ANCOVA|||Statistical analysis applies to the total population.||-9.746|-22.41|<0.0001
91757357|NCT00655629|183407434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.134|||<|0.0001||95.0|-40.281|-25.987|||ANCOVA|||Statistical analysis applies to the total population.||-25.987|-40.281|<0.0001
91757358|NCT00655629|183407435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.934|||<|0.0001||95.0|-41.119|-26.749|||ANCOVA|||Statistical analysis applies to the total population.||-26.749|-41.119|<0.0001
91757359|NCT00655629|183407436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.902|||<|0.0001||95.0|-27.724|-14.081|||ANCOVA|||Statistical analysis applies to the total population.||-14.081|-27.724|<0.0001
91757360|NCT00655629|183407438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.866|||<|0.0001||95.0|-22.599|-11.133|||ANCOVA|||Statistical analysis applies to the total population.||-11.133|-22.599|<0.0001
91757361|NCT00655629|183407439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.04|||<|0.0001||95.0|-31.547|-20.533|||ANCOVA|||Statistical analysis applies to the total population.||-20.533|-31.547|<0.0001
91757362|NCT00655629|183407440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.496|||<|0.0001||95.0|-24.676|-14.315|||ANCOVA|||Statistical analysis applies to the total population.||-14.315|-24.676|<0.0001
91757363|NCT00655629|183407441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.418|||<|0.0001||95.0|-24.439|-12.396|||ANCOVA|||Statistical analysis applies to the total population.||-12.396|-24.439|<0.0001
91757364|NCT00655629|183407442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.379|||<|0.0001||95.0|-28.006|-16.753|||ANCOVA|||Statistical analysis applies to the total population.||-16.753|-28.006|<0.0001
91757365|NCT00655629|183407443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.758|||<|0.0001||95.0|-36.736|-24.779|||ANOVA|||Statistical analysis applies to the total population.||-24.779|-36.736|<0.0001
91757366|NCT00655629|183407444|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|60.2391|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
91757367|NCT02277925|183407445|SUPERIORITY||Risk Ratio (RR)|1.74||||0.3|TWO_SIDED|95.0|0.59|5.14|||Chi-squared|||||5.14|0.59|0.30
91757368|NCT02277925|183407446|SUPERIORITY||Risk Ratio (RR)|1.03||||0.43|TWO_SIDED|95.0|0.96|1.11|||Chi-squared|||||1.11|0.96|0.43
91757369|NCT02277925|183407447|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.39|TWO_SIDED|95.0|-14.7|5.7|||t-test, 2 sided|||||5.7|-14.7|0.39
91757370|NCT00244101|183407455|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.59|1.03||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX or NCPAP.||1.03|0.59|
91757371|NCT00244101|183407455|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.25|1.27||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.27|0.25|
91757372|NCT00244101|183407456|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.94||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX.||1.94|0.49|
91757373|NCT00244101|183407456|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.64|1.09||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.09|0.64|
91757374|NCT04097379|183407457|SUPERIORITY||Least Square Mean|51.7|STANDARD_ERROR_OF_MEAN|71.327||0.2366||90.0|-68.7|172.1|||Mixed effects model for repeated measure|||||172.1|-68.7|0.2366
91511604|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.617||||0.016|TWO_SIDED|95.0|1.159|5.908|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes||5.908|1.159|0.016
91511605|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.995|TWO_SIDED|95.0|0.528|1.885|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention||1.885|0.528|0.995
91511606|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.499||||0.084|TWO_SIDED|95.0|0.945|2.379|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (\>=4 units)||2.379|0.945|0.084
91757375|NCT04097379|183407457|SUPERIORITY||Least Square Mean|38.19|STANDARD_ERROR_OF_MEAN|68.1||0.2892|TWO_SIDED|90.0|-76.7|153.1|||Mixed effects model for repeated measure|||||153.1|-76.7|0.2892
91757376|NCT04617496|183407502|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91757377|NCT04617496|183407503|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91757378|NCT04508530|183407539|SUPERIORITY||Least Squares Mean Difference|1.1||||0.00855|TWO_SIDED|5.0|0.2|2.0|||Mixed Models Analysis|||||2.0|0.2|0.00855
91757379|NCT04508530|183407540|SUPERIORITY||Mean Difference (Net)|-19.0||||0.0718|ONE_SIDED|2.5||6.7|||t-test, 1 sided|||||6.7||0.0718
91757380|NCT04508530|183407541|SUPERIORITY|||||||0.0111|||||||Chi-squared|||||||0.0111
91757381|NCT04530552|183407542|OTHER||See above|0.895|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 50%||||
91757382|NCT04530552|183407542|OTHER||See above|0.943|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 25%||||
91757383|NCT04530552|183407543|OTHER|Two-sided paired t-test at 2.5% significance level (Bonferroni correction)||||||0.034||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.034
91757384|NCT04530552|183407543|OTHER|||||||0.252||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.252
91511607|NCT00097591|182895026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.313||||0.022|TWO_SIDED|95.0|1.04|1.656|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Minor Bleeding||1.656|1.040|0.022
91511608|NCT00097591|182895027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784|||<|0.001|TWO_SIDED|95.0|0.688|0.894|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.894|0.688|<0.001
91511609|NCT00097591|182895027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794|||<|0.001|TWO_SIDED|95.0|0.703|0.896|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.896|0.703|<0.001
91511610|NCT00097591|182895028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.672|0.876|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.876|0.672|<0.001
91757385|NCT04530552|183407544|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
91757386|NCT04530552|183407544|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
91757387|NCT04530552|183407545|OTHER|||||||0.658||||||two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.658
91757388|NCT04530552|183407545|OTHER|||||||0.167||||||Two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.167
91757389|NCT00454584|183407566|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
91757390|NCT00454584|183407566|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.|Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05. Sample Size: Assuming the PASI 75 response rates of ustekinumab 90 mg, 45 mg, etanercept are 65%, 64%, and 50% , respectively, with 325 participants each in the ustekinumab 90 mg and etanercept groups, the power to detect a treatment difference is 97%. With 200 participants in the ustekinumab 45 mg group, the complete power to further detect a treatment difference was 87%.||||0.012
91757391|NCT00454584|183407567|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
91757392|NCT00454584|183407567|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
91757393|NCT00454584|183407568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
91757394|NCT00454584|183407568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
91759898|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-11.57|6.38||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.38|-11.57|
91511611|NCT00097591|182895028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797|||<|0.001|TWO_SIDED|95.0|0.705|0.901|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.901|0.705|<0.001
91511612|NCT00097591|182895029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838|||<|0.001|TWO_SIDED|95.0|0.762|0.921|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.921|0.762|<0.001
91511613|NCT00097591|182895030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831|||<|0.001|TWO_SIDED|95.0|0.751|0.919|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.919|0.751|<0.001
91757395|NCT02250664|183407570|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
91757396|NCT02250664|183407570|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANOVA|||The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.|Group difference = 0.03 mg nicotine - 0.8 mg nicotine|-5.57|-9.51|<0.0001
91757397|NCT02522442|183407578|OTHER|Pilot study, not powered for any endpoint.||||||0.377|||||||Chi-squared|||Pilot study, not powered for any endpoint.||||0.377
91757398|NCT02522442|183407579|OTHER|Pilot study, not powered for any endpoint.||||||0.624|||||||Chi-squared|||||||.624
91757399|NCT00975143|183407583|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference \< 4.|LS Mean Difference|0.1382||||0.5077|TWO_SIDED|95.0|-0.2712|0.5475||P values are from analysis of covariance (ANCOVA) controlling for Baseline total nodular lesion count, gender and analysis site.|ANCOVA|The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was calculated using the ANCOVA model.||Change from Baseline was calculated as the post-Baseline value minus the Baseline value||0.5475|-0.2712|0.5077
91757400|NCT00975143|183407584|NON_INFERIORITY_OR_EQUIVALENCE|If the two co-primary endpoints were significant, a 95% 2 sided CI on the difference between treatments (CIP-Isotretinoin minus Isotretinoin) was calculated.|Proportion difference|-3.48|||>|0.05|TWO_SIDED|95.0|-8.4|1.4|||Normal approximation|95% CI on difference in proportions (CIP-Isotretinoin minus Isotretinoin) was estimated using normal approximation.||The analysis of the secondary efficacy endpoint was based on observed cases only, with no imputation for missing values.||1.4|-8.4|>0.05
91757401|NCT00975143|183407585|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference \> -10.|Proportion difference|-2.1|||>|0.05|TWO_SIDED|95.0|-7.94|3.74|||Normal approximation|||||3.74|-7.94|>0.05
91757402|NCT02428413|183407626|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
91757403|NCT02428413|183407627|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
91757404|NCT00915551|183407735|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91757405|NCT00915551|183407736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91757406|NCT01031979|183407749|SUPERIORITY_OR_OTHER||Beta|-1.44|||<|0.001|TWO_SIDED|95.0|-2.29|-0.59|||mixed effects/hierarchical linear model|||||-0.59|-2.29|<0.001
91757407|NCT01031979|183407750|SUPERIORITY_OR_OTHER||Slope|-0.87||||0.39|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.39
91757408|NCT01031979|183407751|SUPERIORITY_OR_OTHER||Slope|-0.55||||0.58|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.58
91757409|NCT01031979|183407752|SUPERIORITY_OR_OTHER||Beta|-1.6||||0.03|TWO_SIDED|95.0|-2.71|-0.49|||Hierarchical Linear Modeling|||||-0.49|-2.71|.03
91757410|NCT03831100|183407753|SUPERIORITY||Mean Difference (Net)|-2.1||||0.25|TWO_SIDED|90.0|-5.0|0.9||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.9|-5.0|0.25
91759899|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.75|||||TWO_SIDED|95.0|-22.73|-4.78||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.78|-22.73|
91511614|NCT00563797|182895035|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||F=7.73|Mixed Models Analysis|||Comparison is between baseline and during treatment.||||0.014
91511615|NCT00563797|182895036|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||F=36.32|Mixed Models Analysis|||Comparison of baseline and post-treatment||||.0001
91511616|NCT00563797|182895037|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Mixed Models Analysis|||||||.025
91511617|NCT00563797|182895038|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||||||.019
91511618|NCT03264157|182895039|NON_INFERIORITY|The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 \> -0.1, where p is the proportion of subjects with anti-rabies titer of \>0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 \> -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.|lower 95% CI|-0.05||||0.0006|ONE_SIDED|95.0|-0.05|||The threshold for this test is \<=0.025.|Farrington and Manning test||||||-0.05|0.0006
91511619|NCT03264157|182895040|NON_INFERIORITY|The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.|lower 95% CI|0.74|||||TWO_SIDED|95.0|0.74|0.94||||||||0.94|0.74|
91757411|NCT03831100|183407754|SUPERIORITY||Mean Difference (Net)|-5.8||||0.006|TWO_SIDED|90.0|-9.1|-2.5||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||-2.5|-9.1|.006
91511620|NCT03264157|182895041|SUPERIORITY||95% CI|0.97|||||TWO_SIDED||||||||Data analyzed as log normal. The value presented is the untransformed value of the difference between means.|||||
91757412|NCT03831100|183407755|SUPERIORITY||Mean Difference (Net)|-7.9||||0.1|TWO_SIDED|90.0|-15.9|0.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.0|-15.9|.10
91511621|NCT03264157|182895042|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|-0.05||||0.0006|TWO_SIDED|95.0|-0.05|0.1|||Farrington and Manning test|||||0.10|-0.05|0.0006
91757413|NCT03831100|183407756|SUPERIORITY||Mean Difference (Net)|-17.1||||0.002|TWO_SIDED|90.0|-25.6|-8.6||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear|||||-8.6|-25.6|.002
91757414|NCT03831100|183407757|SUPERIORITY||Mean Difference (Net)|-3.4||||0.3|TWO_SIDED|90.0|-8.8|2.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores|||2.0|-8.8|0.30
91757415|NCT03831100|183407758|SUPERIORITY||Median Difference (Net)|-9.7||||0.005|TWO_SIDED|90.0|-15.2|-4.2||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-4.2|-15.2|0.005
91757416|NCT03831100|183407759|SUPERIORITY||Mean Difference (Net)|-3.4||||0.064|TWO_SIDED|90.0|-6.4|0.4||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.4|-6.4|0.064
91757417|NCT03831100|183407760|SUPERIORITY||Mean Difference (Net)|-4.3||||0.046|TWO_SIDED|90.0|-7.8|-0.8||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.8|-7.8|0.046
91757418|NCT03831100|183407761|SUPERIORITY||Mean Difference (Net)|-1.5||||0.49|TWO_SIDED|90.0|-5.2|2.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||2.1|-5.2|0.49
91757419|NCT03831100|183407762|SUPERIORITY||Mean Difference (Net)|-3.1||||0.14|TWO_SIDED|90.0|-6.5|0.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.3|-6.5|0.14
91757420|NCT03831100|183407763|SUPERIORITY||Mean Difference (Net)|3.2||||0.082|TWO_SIDED|90.0|0.2|6.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||6.3|0.2|0.082
91757421|NCT03831100|183407764|SUPERIORITY||Mean Difference (Net)|2.7||||0.15|TWO_SIDED|90.0|-0.4|5.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||5.7|-0.4|0.15
91757422|NCT03831100|183407765|SUPERIORITY||Mean Difference (Net)|-2.2||||0.22|TWO_SIDED|90.0|-5.2|-0.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.7|-5.2|0.22
91757423|NCT03831100|183407766|SUPERIORITY||Mean Difference (Net)|-2.9||||0.093|TWO_SIDED|90.0|-5.8|-0.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.1|-5.8|0.093
91511622|NCT03264157|182895043|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|0.0||||0|TWO_SIDED|95.0|0.0|0.0|||Farrington and Manning test||For Day 14, all subjects achieved the endpoint (RVNA titer \> LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.|||0|0|0
91757424|NCT01732770|183407779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% confidence interval (CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.46% for assessing non-inferiority.|Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||2.6|1.6|<0.0001
91759900|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-9.32|8.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.88|-9.32|
91759901|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.28|||||TWO_SIDED|95.0|-21.39|-3.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.17|-21.39|
91511623|NCT00009737|182895045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.|Hazard Ratio (HR)|0.87||||0.053|TWO_SIDED|95.0|0.75|1.0||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.00|0.75|0.053
91511624|NCT00009737|182895046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.86||||0.041|TWO_SIDED|95.0|0.74|0.99||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||0.99|0.74|0.041
91511625|NCT00009737|182895047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.84||||0.071|TWO_SIDED|95.0|0.69|1.01||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.01|0.69|0.071
91511626|NCT04188041|182895059|OTHER|see above||||||0.02|||||||Wilcoxon signed rank test|||Non-parametric Wilcoxon signed rank test for paired data was used to test for significant change in confidence.||||0.02
91511627|NCT02248922|182895092|OTHER|||||||0.4099|||||||ANOVA|||||||0.4099
91511628|NCT02248922|182895093|OTHER|||||||0.6961|||||||ANOVA|||||||0.6961
91511629|NCT02248922|182895094|OTHER|||||||0.354|||||||ANOVA|||||||0.3540
91511630|NCT02248922|182895095|OTHER|||||||0.591|||||||ANOVA|||||||0.5910
91757425|NCT01732770|183407780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.51% for assessing non-inferiority.|Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||1.7|1.0|<0.0001
91511631|NCT02248922|182895096|OTHER|||||||0.4249|||||||ANOVA|||||||0.4249
91511632|NCT02248922|182895097|OTHER|||||||0.3963|||||||ANOVA|||||||0.3963
91511633|NCT02248922|182895098|OTHER|||||||0.3502|||||||ANOVA|||||||0.3502
91511634|NCT02708745|182895105|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||.29
91511635|NCT02708745|182895106|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
91511636|NCT02708745|182895107|SUPERIORITY|||||||0.78||||||For the barrier 'not having enough time to discuss vaccine concerns', P=0.78. For the barrier 'not realizing until late in visit that parent had vaccine concerns', P=0.37. For the barrier 'not understanding parent specific vaccine concerns', P=0.66.|Chi-squared|||||||0.78
91511637|NCT01298063|182895115|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.64|STANDARD_DEVIATION|33.6||0.1998|TWO_SIDED|90.0|67.96|126.27||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||126.270|67.960|0.1998
91757426|NCT01732770|183407781|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||2.6|1.6|<0.0001
91757427|NCT01732770|183407782|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||1.7|1.0|<0.0001
91757428|NCT04493281|183407801|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-t for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
91757429|NCT04493281|183407802|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-inf for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||||1.04|0.92|
91757430|NCT04493281|183407803|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|1.22|||||TWO_SIDED|90.0|1.09|1.36||||||||1.36|1.09|
91757431|NCT03176771|183407848|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.5|-2.6|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): MT-5199 80 mg vs. placebo.~* AIMS: MT-5199 40 mg vs. PBO. For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.6|-4.5|<0.001
91757432|NCT03176771|183407848|SUPERIORITY||Median Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.3|||Mixed-effect Model Repeated Measures|||||-1.3|-3.0|<0.001
91757433|NCT03176771|183407849|SUPERIORITY||Risk Difference (RD)|13.6||||0.027|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.027
91757434|NCT03176771|183407849|SUPERIORITY||Risk Difference (RD)|36.9|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91757435|NCT03176771|183407850|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.013|TWO_SIDED|95.0|-2.7|-0.3|||Mixed-effect Model Repeated Measures|||||-0.3|-2.7|0.013
91757436|NCT03176771|183407850|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||Mixed-effect Model Repeated Measures|||||-1.1|-3.5|<0.001
91757437|NCT03176771|183407851|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.021|TWO_SIDED|95.0|-0.7|-0.1|||ANOVA|||||-0.1|-0.7|0.021
91757438|NCT03176771|183407851|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANOVA|||||-0.3|-1.0|<0.001
91757439|NCT04776135|183407866|OTHER|AUC0-t was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.987|||||TWO_SIDED|90.0|0.936|1.041|||ANOVA|||For AUC0-t, MT-1186 orally Versus MT-1186 via NGT||1.041|0.936|
91757440|NCT04776135|183407866|OTHER|AUC0-inf was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.981|||||TWO_SIDED|90.0|0.931|1.033|||ANOVA|||For AUC0-inf, MT-1186 orally Versus MT-1186 via NGT||1.033|0.931|
91757441|NCT04776135|183407867|OTHER|Cmax was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|1.052|||||TWO_SIDED|90.0|0.903|1.227|||ANOVA|||MT-1186 orally Versus MT-1186 via NGT||1.227|0.903|
91757442|NCT03392649|183407900|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
91757443|NCT03392649|183407901|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
91757444|NCT03392649|183407902|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91757445|NCT03392649|183407903|SUPERIORITY|||||||0.09|||||||Fisher Exact|||||||0.09
91757446|NCT03392649|183407904|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
91757447|NCT03392649|183407905|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
91757448|NCT03392649|183407906|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91511638|NCT01298063|182895115|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.88|STANDARD_DEVIATION|31.6||0.144|TWO_SIDED|90.0|72.278|124.549||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.549|72.278|0.1440
91757449|NCT03392649|183407907|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
91757450|NCT03703856|183407915|SUPERIORITY|||||||0.68||||||The threshold for statistical significance was p=0.05|ANOVA|||Change in ADAS-Cog score over time||||0.68
91757451|NCT03703856|183407916|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p=0.05|ANOVA|||||||>0.05
91757452|NCT03703856|183407917|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance is p=0.05|ANOVA|||||||>0.05
91511639|NCT01298063|182895116|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|109.47|STANDARD_DEVIATION|30.3||0.2002|TWO_SIDED|90.0|82.683|144.947||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||144.947|82.683|0.2002
91757453|NCT01192412|183407942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.35||||||We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan-DeMets spending function with O'Brien-Fleming-type boundaries for early stopping.||1.35|0.77|
91757454|NCT01192412|183407943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|0.79|3.84||||||||3.84|0.79|
91757455|NCT02421588|183407944|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.6294|TWO_SIDED|95.0|0.854|1.309|||Log Rank|||PFS between treatments||1.309|0.854|0.6294
91757456|NCT02421588|183407944|SUPERIORITY||PFS at 6 months|24.3|||||TWO_SIDED|95.0|18.4|30.7|||||Percent of Participants|PFS (%) at 6 months||30.7|18.4|
91757457|NCT02421588|183407944|SUPERIORITY||PFS at 6 months|27.5|||||TWO_SIDED|95.0|20.9|34.4|||||Percent of Participants|PFS (%) at 6 months||34.4|20.9|
91757458|NCT02421588|183407944|SUPERIORITY|||||||0.5032|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.5032
91757459|NCT02421588|183407944|SUPERIORITY||PFS at 12 months|8.3|||||TWO_SIDED|95.0|4.7|13.3|||||Percent of Participants|PFS (%) at 12 months||13.3|4.7|
91757460|NCT02421588|183407944|SUPERIORITY||PFS at 12 months|7.0|||||TWO_SIDED|95.0|3.3|12.5|||||Percent of Participants|PFS (%) at 12 months||12.5|3.3|
91757461|NCT02421588|183407944|SUPERIORITY|||||||0.6742|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.6742
91757462|NCT02421588|183407945|SUPERIORITY||Hazard Ratio (HR)|0.987||||0.7673|TWO_SIDED|95.0|0.805|1.209|||Log Rank|||PFS between treatments||1.209|0.805|0.7673
91757463|NCT02421588|183407945|SUPERIORITY||PFS at 6 months|29.0|||||TWO_SIDED|95.0|22.8|35.4|||||Percent of Participants|PFS (%) at 6 months||35.4|22.8|
91757464|NCT02421588|183407945|SUPERIORITY||PFS at 6 months|27.4|||||TWO_SIDED|95.0|21.3|33.9|||||Percent of Participants|PFS (%) at 6 months||33.9|21.3|
91757465|NCT02421588|183407945|SUPERIORITY|||||||0.7385|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.7385
91757466|NCT02421588|183407945|SUPERIORITY||PFS (%) at 12 months|8.2|||||TWO_SIDED|95.0|4.8|12.7|||||Percent of Participants|PFS (%) at 12 months||12.7|4.8|
91757467|NCT02421588|183407945|SUPERIORITY||PFS (%) at 12 months|7.5|||||TWO_SIDED|95.0|4.2|12.2|||||Percent of Participants|PFS (%) at 12 months||12.2|4.2|
91757468|NCT02421588|183407945|SUPERIORITY|||||||0.8245|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.8245
91757469|NCT02421588|183407946|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.8021|TWO_SIDED|95.0|0.772|1.183|||Log Rank|||OS between treatments||1.183|0.772|0.8021
91757470|NCT02421588|183407946|SUPERIORITY||OS at 12 months|48.2|||||TWO_SIDED|95.0|41.3|54.8|||||Percent of Participants|OS (%) at 12 months||54.8|41.3|
91757471|NCT02421588|183407946|SUPERIORITY||OS (%) at 12 months|45.3|||||TWO_SIDED|95.0|38.4|52.0|||||Percent of Participants|OS (%) at 12 months||52.0|38.4|
91757472|NCT02421588|183407946|SUPERIORITY|||||||0.5515|||||||Normal approximation|||OS (%) at 12 months between treatments||||0.5515
91757473|NCT02421588|183407946|SUPERIORITY||OS (%) at 24 months|22.3|||||TWO_SIDED|95.0|16.8|28.2|||||Percent of Participants|OS (%) at 24 months||28.2|16.8|
91757474|NCT02421588|183407946|SUPERIORITY||OS (%) at 24 months|22.7|||||TWO_SIDED|95.0|17.1|28.7|||||Percent of Participants|OS (%) at 24 months||28.7|17.1|
91757475|NCT02421588|183407946|SUPERIORITY|||||||0.9253|||||||Normal approximation|||OS (%) at 24 months between treatments||||0.9253
91757476|NCT02421588|183407947|SUPERIORITY||ORR|14.5|||||TWO_SIDED|95.0|10.1|19.8|||||Percent of Participants|Overall response rate||19.8|10.1|
91757477|NCT02421588|183407947|SUPERIORITY||ORR|12.7|||||TWO_SIDED|95.0|8.6|17.8|||||Percent of Participants|Overall response rate||17.8|8.6|
91511640|NCT01298063|182895116|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|126.89|STANDARD_DEVIATION|42.8||0.5281|TWO_SIDED|90.0|86.028|187.159||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||187.159|86.028|0.5281
91511641|NCT01298063|182895117|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|90.61|STANDARD_DEVIATION|32.8||0.2309|TWO_SIDED|90.0|66.915|122.705||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||122.705|66.915|0.2309
91511642|NCT01298063|182895117|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.49|STANDARD_DEVIATION|32.4||0.1546|TWO_SIDED|90.0|71.563|124.764||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.764|71.563|0.1546
91511643|NCT04632940|182895126|OTHER||LS Mean Difference|-0.528|STANDARD_ERROR_OF_MEAN|0.8912||0.5553|TWO_SIDED|95.0|-2.308|1.251|||Mixed Models Analysis|||||1.251|-2.308|0.5553
91511644|NCT02550652|182895200|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|95.0|-3.4|28.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||28.1|-3.4|0.1145
91511645|NCT02550652|182895200|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|80.0|2.1|22.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|Difference in Percentage of Participants||||22.6|2.1|0.1145
91511646|NCT02550652|182895201|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246||95.0|3.0|37.2||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||37.2|3.0|0.0246
91511647|NCT02550652|182895201|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246|TWO_SIDED|80.0|8.9|31.3||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||31.3|8.9|0.0246
91511648|NCT02550652|182895202|SUPERIORITY|||||||0.0744|||||||Log Rank|||||||0.0744
91511649|NCT02550652|182895203|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015||95.0|4.7|38.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||38.7|4.7|0.0150
91511650|NCT02550652|182895203|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015|TWO_SIDED|80.0|10.6|32.8||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||32.8|10.6|0.0150
91511651|NCT02550652|182895204|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|95.0|-17.5|13.4||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||13.4|-17.5|0.8461
91511652|NCT02550652|182895204|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|80.0|-12.1|8.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||8.1|-12.1|0.8461
91511653|NCT02550652|182895205|SUPERIORITY|||||||0.353|||||||Log Rank|||||||0.3530
91757478|NCT02421588|183407947|SUPERIORITY|||||||0.6772|||||||Fisher Exact|||Overall response rate between treatments||||0.6772
91757479|NCT02421588|183407948|SUPERIORITY||ORR|15.8|||||TWO_SIDED|95.0|11.3|21.3|||||Percent of Participants|Overall response rate (ORR)||21.3|11.3|
91757480|NCT02421588|183407948|SUPERIORITY||Overall response rate (ORR)|16.7|||||TWO_SIDED|95.0|12.1|22.3|||||Percent of Participants|Overall response rate (ORR)||22.3|12.1|
91757481|NCT02421588|183407948|SUPERIORITY|||||||0.8976|||||||Fisher Exact|||Overall response rate (ORR) between treatments||||0.8976
91757482|NCT02421588|183407949|SUPERIORITY||Hazard Ratio (HR)|1.406||||0.2631|TWO_SIDED|95.0|0.769|2.569|||Log Rank|||Duration of response between treatments||2.569|0.769|0.2631
91757483|NCT02421588|183407950|SUPERIORITY|Duration of response between treatments|Hazard Ratio (HR)|1.056||||0.8276|TWO_SIDED|95.0|0.64|1.743|||Log Rank|||||1.743|0.64|0.8276
91757484|NCT02421588|183407951|SUPERIORITY||ORR (%)|26.6|||||TWO_SIDED|95.0|20.2|33.8|||||Percent of Participants|ORR (%) by CA-125||33.8|20.2|
91757485|NCT02421588|183407951|SUPERIORITY||ORR (%)|19.4|||||TWO_SIDED|95.0|13.7|26.3|||||Percent of Participants|ORR (%) by CA-125||26.3|13.7|
91757486|NCT02421588|183407951|SUPERIORITY|||||||0.1231|||||||Fisher Exact|||ORR (%) by CA-125 between treatments||||0.1231
91757487|NCT03436693|183408029|OTHER|Point Estimate|Difference(Multiple imputation method)|11.3|||||TWO_SIDED|95.0|1.2|21.5||||||||21.5|1.2|
91757488|NCT03436693|183408030|OTHER|Point Estimate|Difference(Multiple imputation method)|3.8|||||TWO_SIDED|95.0|-4.1|11.7||||||||11.7|-4.1|
91757489|NCT03436693|183408031|SUPERIORITY||Difference of LSMean|1.09||||0.351|TWO_SIDED|95.0|-1.21|3.4|||Mixed Models Analysis|||||3.40|-1.21|0.351
91757490|NCT03436693|183408032|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.293|TWO_SIDED|95.0|0.23|1.55|||Regression, Cox|||||1.55|0.23|0.293
91757491|NCT03436693|183408033|SUPERIORITY||Ratio of Geometric LSMean|0.52|||<|0.001|TWO_SIDED|95.0|0.418|0.646|||Mixed Models Analysis|||||0.646|0.418|<0.001
91757492|NCT04481789|183408034|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin Alone).|LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.08|0.97|
91511654|NCT02550652|182895206|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.491||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.491|-1.13|<0.0001
91511655|NCT02550652|182895206|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|80.0|-1.019|-0.602||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.602|-1.019|<0.0001
91511656|NCT02550652|182895207|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|95.0|0.081|0.275||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.275|0.081|0.0004
91511657|NCT02550652|182895207|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|80.0|0.115|0.241|||ANCOVA|||||0.241|0.115|0.0004
91511658|NCT02550652|182895208|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001||95.0|0.052|0.124|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).||||0.124|0.052|<0.0001
91757493|NCT04481789|183408034|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.99||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||0.99|0.88|
91511659|NCT02550652|182895208|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001|TWO_SIDED|80.0|0.065|0.112||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.112|0.065|<0.0001
91757494|NCT04481789|183408034|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.98|1.09||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.09|0.98|
91757495|NCT04481789|183408035|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin).|LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.06||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.06|0.91|
91511660|NCT02550652|182895209|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09||95.0|-2.4|30.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||30.1|-2.4|0.0900
91757496|NCT04481789|183408035|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.8|1.1||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.10|0.80|
91757497|NCT04481789|183408035|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.08|||||TWO_SIDED|90.0|0.96|1.23||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.23|0.96|
91511661|NCT02550652|182895209|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09|TWO_SIDED|80.0|3.2|24.5||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||24.5|3.2|0.0900
91511662|NCT02550652|182895210|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|95.0|-6.4|27.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||27.6|-6.4|0.1838
91511663|NCT02550652|182895210|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|80.0|-0.5|21.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||21.7|-0.5|0.1838
91757498|NCT04481789|183408050|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.842|||||TWO_SIDED|90.0|0.697|1.017||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.017|0.697|
91511664|NCT02550652|182895211|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|95.0|-10.0|24.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||24.6|-10.0|0.3726
91511665|NCT02550652|182895211|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|80.0|-4.0|18.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||18.6|-4.0|0.3726
91511666|NCT01706250|182895222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.29|STANDARD_DEVIATION|32.98||0.6779|||||||t-test, 2 sided|||Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6779
91511667|NCT01706250|182895222|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.68|STANDARD_DEVIATION|29.51||0.2847|||||||t-test, 2 sided|||Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.2847
91511668|NCT01706250|182895222|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.24|STANDARD_DEVIATION|23.35||0.6894|||||||t-test, 2 sided|||Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6894
91511669|NCT01706250|182895223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.38|STANDARD_DEVIATION|50.1||0.9909|||||||Signed Rank|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)||||0.9909
91511670|NCT01706250|182895223|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0|STANDARD_DEVIATION|39.91||0.6671|||||||t-test, 2 sided|||IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)||||0.6671
91757499|NCT04481789|183408050|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.737|||||TWO_SIDED|90.0|0.61|0.891||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.891|0.610|
91511671|NCT01706250|182895223|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.64|STANDARD_DEVIATION|52.05||0.0632|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)||||0.0632
91511672|NCT01706250|182895224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|42.31||0.7385|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)||||0.7385
91511673|NCT01706250|182895224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.04|STANDARD_DEVIATION|37.77||0.7296|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)||||0.7296
91511674|NCT01706250|182895224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_DEVIATION|36.11||0.3774|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)||||0.3774
91757500|NCT04481789|183408051|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.657|||||TWO_SIDED|90.0|0.379|1.137||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.137|0.379|
91757501|NCT04481789|183408051|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.522|||||TWO_SIDED|90.0|0.301|0.903||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.903|0.301|
91511675|NCT01706250|182895225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_DEVIATION|29.53||0.7634|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)||||0.7634
91511676|NCT01706250|182895225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.75|STANDARD_DEVIATION|29.61||0.4087|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)||||0.4087
91511677|NCT01706250|182895225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|25.4||0.2455|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)||||0.2455
91511678|NCT01706250|182895226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
91511679|NCT01706250|182895226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.56||0.125|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.1250
91511680|NCT01706250|182895226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||0.625|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.6250
91511681|NCT01706250|182895226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||1.0000
91511682|NCT01706250|182895227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.45||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
91511683|NCT01706250|182895227|SUPERIORITY_OR_OTHER||Signed Rank|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
91511684|NCT01706250|182895228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.22||1|||||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.00
91511685|NCT01706250|182895228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||1.0000
91511686|NCT01706250|182895229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||1|||||||Signed rank|||Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
91511687|NCT01706250|182895230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_DEVIATION|0.67||0.5313||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5313
91511688|NCT01706250|182895230|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.16|STANDARD_DEVIATION|0.6||0.5||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.5000
91511689|NCT01706250|182895230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.75|||||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.7500
91511690|NCT01706250|182895230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.84||0.25|||||||Signed rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
91511691|NCT01706250|182895231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.86||0.2131|||||||Signed Rank)|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.2131
91511692|NCT01706250|182895231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_DEVIATION|1.16||0.2656||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.2656
91511693|NCT01706250|182895231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.2344||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2344
91511694|NCT01706250|182895231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.73||0.3594||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3594
91511695|NCT01706250|182895232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.32||0.6172|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.6172
91511696|NCT01706250|182895232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.93||0.3984|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.3984
91511697|NCT01706250|182895232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_DEVIATION|1.1||0.0781||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.0781
91511698|NCT01706250|182895232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.24||0.375||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3750
91511699|NCT01706250|182895233|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|0.46||1||95.0|||||[Signed Rank]|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
91511700|NCT01706250|182895233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_DEVIATION|0.58||0.0625||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.0625
91511701|NCT01706250|182895233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2500
91511702|NCT01706250|182895233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.38||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
91511703|NCT01706250|182895234|SUPERIORITY_OR_OTHER||Signed Rank|0.15|STANDARD_DEVIATION|0.59||0.5||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5000
91511704|NCT01706250|182895234|SUPERIORITY_OR_OTHER||Signed Rank|0.11|STANDARD_DEVIATION|0.57||0.75||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.7500
91757502|NCT05216224|183408064|SUPERIORITY||LS Mean Difference|3.01|||>|0.999|TWO_SIDED|90.0|1.5|4.52||Significance level of 0.05|MMRM|Fixed effect terms for treatment, study visit, treatment by visit interaction and baseline count of inflammatory abscesses and nodules as a covariate.||||4.52|1.50|>0.999
91757503|NCT03245008|183408072|SUPERIORITY||Least Squares Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.57|-0.86||Adjusted P-value|Mixed Models Analysis|||||-0.86|-1.57|<0.001
91757504|NCT03245008|183408072|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.21||0.103|TWO_SIDED|95.0|-0.76|0.07||Adjusted P-value|Mixed Models Analysis|||||0.07|-0.76|0.103
91511705|NCT01706250|182895234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.62||0.4531||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.4531
91511706|NCT01706250|182895234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.625||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.6250
91511707|NCT02486406|182895249|SUPERIORITY||Wilson's score method|98.4|||||TWO_SIDED|95.0|91.7|99.7||||||According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%.||99.7|91.7|
91757505|NCT03245008|183408073|SUPERIORITY||Least Squares Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.6|-0.92||Adjusted P-value|Mixed Models Analysis|||||-0.92|-1.60|<0.001
91757506|NCT03245008|183408073|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.84|-0.05||||||||-0.05|-0.84|
91757507|NCT02678923|183408102|SUPERIORITY||LS mean difference|0.73||||0.0738|TWO_SIDED|95.0|-0.07|1.52||Baseline parameter value as a covariate and treatment group as factor, adjusting for country and prior statin use.|ANCOVA|||||1.52|-0.07|0.0738
91757508|NCT00552409|183408198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-56.0|251.0|||Regression, Linear||Mean urine ACR on treatment was 17% lower among participants assigned to cholecalciferol, compared to participants assigned to placebo, adjusted for baseline values.|||251|-56|
91757509|NCT01304589|183408200|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
91757510|NCT01304589|183408201|SUPERIORITY_OR_OTHER|||||||0.003||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|paired T-test|"Subjects completed a tampon insertion pain test once a week. The values were averaged and compared pre-treatment versus post-treatment."||||||.003
91757511|NCT01304589|183408202|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
91757512|NCT01304589|183408203|SUPERIORITY_OR_OTHER||||||<|0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||<.001
91757513|NCT00659230|183408222|SUPERIORITY_OR_OTHER||Effect Size|-0.18||||0.723|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|The analysis was conducted using a repeated-measures analysis of variance (ANOVA) model. The model consisted of two factors - treatment at two levels and time (5 time points including baseline) and group by time interaction.||0.27|-0.64|0.723
91757514|NCT00659230|183408223|SUPERIORITY||Effect Size|-0.07||||0.54|TWO_SIDED|90.0|-0.52|0.39|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.39|-.52|0.540
91757515|NCT00659230|183408224|SUPERIORITY||Effect size|-0.18||||0.951|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.27|-0.64|0.951
91757516|NCT00659230|183408225|SUPERIORITY||Effect Size|0.11||||0.396|TWO_SIDED|90.0|-0.35|0.56|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.56|-0.35|0.396
91757517|NCT05342597|183408250|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.025|||||TWO_SIDED|90.0|0.931|1.128|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.128|0.931|
91757518|NCT05342597|183408250|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.959|||||TWO_SIDED|90.0|0.871|1.056|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.056|0.871|
91757519|NCT05342597|183408250|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.827|1.002|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.002|0.827|
91757520|NCT05342597|183408250|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.801|||||TWO_SIDED|90.0|0.712|0.901|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.901|0.712|
91757521|NCT05342597|183408251|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.083|||||TWO_SIDED|90.0|0.821|1.429|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.429|0.821|
91511708|NCT01196871|182895253|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.942|||||TWO_SIDED|90.0|2.439|3.548|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% confidence interval (CI) are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.548|2.439|
91511709|NCT01196871|182895253|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.942|||||TWO_SIDED|90.0|2.431|3.56|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.560|2.431|
91511710|NCT01196871|182895253|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.354|||||TWO_SIDED|90.0|1.826|3.035|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.035|1.826|
91757522|NCT05342597|183408251|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.872|||||TWO_SIDED|90.0|0.661|1.15|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.150|0.661|
91757523|NCT05342597|183408251|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.82|||||TWO_SIDED|90.0|0.621|1.082|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.082|0.621|
91757524|NCT05342597|183408251|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.536|||||TWO_SIDED|90.0|0.362|0.794|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.794|0.362|
91757525|NCT02354222|183408286|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.16|-0.72|||ANCOVA|||||-0.72|-1.16|<0.001
91757526|NCT02354222|183408287|SUPERIORITY||Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.3|-7.9|||ANCOVA|||||-7.9|-23.3|<0.001
91757527|NCT02354222|183408288|SUPERIORITY||Least Squares Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.63|2.23|||ANCOVA|||||2.23|0.63|<0.001
91757528|NCT02354222|183408289|SUPERIORITY||Least Squares Mean Difference|-55.9|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-74.1|-37.6|||ANCOVA|||||-37.6|-74.1|<0.001
91757529|NCT02354222|183408290|SUPERIORITY||Least Squares Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-49.9|-25.2|||ANCOVA|||||-25.2|-49.9|<0.001
91757530|NCT02159118|183408386|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91757531|NCT02159118|183408387|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91757532|NCT02159118|183408388|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91757533|NCT02159118|183408389|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
91757534|NCT02159118|183408390|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91757535|NCT02159118|183408391|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
91511711|NCT01196871|182895253|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.375|||||TWO_SIDED|90.0|1.839|3.068|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.068|1.839|
91511712|NCT01196871|182895254|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.629|||||TWO_SIDED|90.0|1.44|1.843|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.843|1.440|
91511713|NCT01196871|182895254|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.546|||||TWO_SIDED|90.0|1.3|1.838|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.838|1.300|
91513561|NCT03029208|182898975|SUPERIORITY||LS mean difference|-4.11||||0.9663|TWO_SIDED|95.0|-8.52|0.3|||MMRM||Chest pain/Shortness of breath domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.30|-8.52|0.9663
91757536|NCT02159118|183408392|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91757537|NCT02159118|183408393|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
91757538|NCT02159118|183408394|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91757539|NCT01716104|183408432|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
91757540|NCT01716104|183408433|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
91757541|NCT01716104|183408434|SUPERIORITY|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
91757542|NCT01716104|183408435|SUPERIORITY|||||||0.0011|||||||Mixed Models Analysis|||||||0.0011
91757543|NCT01716104|183408436|SUPERIORITY|||||||0.0054|||||||Mixed Models Analysis|||||||0.0054
91757544|NCT01716104|183408437|SUPERIORITY|||||||0.0437|||||||Mixed Models Analysis|||||||0.0437
91757545|NCT01716104|183408438|SUPERIORITY|||||||0.0862|||||||Mixed Models Analysis|||||||0.0862
91757546|NCT01716104|183408439|SUPERIORITY|||||||0.0621|||||||Mixed Models Analysis|||||||0.0621
91757547|NCT01716104|183408440|SUPERIORITY|||||||0.0142|||||||Mixed Models Analysis|||||||0.0142
91757548|NCT00117793|183408442|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb volume was analyzed using repeated measures one-way analyses of variance.||||||>0.05
91757549|NCT00117793|183408443|SUPERIORITY_OR_OTHER||||||=|0.0056||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on activity level was analyzed using repeated measures one-way analyses of variance.||||||=0.0056
91757550|NCT00117793|183408444|SUPERIORITY_OR_OTHER||||||=|0.0021||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb pistoning was analyzed using repeated measures one-way analyses of variance.||||||=0.0021
91757551|NCT01818492|183408450|SUPERIORITY|||||||0.0134|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0134
91757552|NCT01818492|183408451|SUPERIORITY|||||||0.0031|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0031
91757553|NCT01818492|183408452|SUPERIORITY|||||||0.0205|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0205
91757554|NCT01818492|183408453|SUPERIORITY|||||||0.0053|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0053
91757555|NCT02772978|183408470|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale, non-planning subscale.||||0.04
91757556|NCT02772978|183408471|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|||||||< 0.05
91757557|NCT03624127|183408516|SUPERIORITY||Odds Ratio (OR)|18.71|||<|0.0001|TWO_SIDED|95.0|9.51|36.81|||Cochran-Mantel-Haenszel|||||36.81|9.51|<0.0001
91513562|NCT03029208|182898975|SUPERIORITY||LS mean difference|-6.6||||0.993|TWO_SIDED|95.0|-11.84|-1.35|||MMRM||Cognitive domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-1.35|-11.84|0.9930
91757558|NCT03624127|183408517|SUPERIORITY||Odds Ratio (OR)|11.09|||<|0.0001|TWO_SIDED|95.0|6.49|18.95|||Cochran-Mantel-Haenszel|||||18.95|6.49|<0.0001
91757559|NCT03624127|183408518|SUPERIORITY||Odds Ratio (OR)|16.15|||<|0.0001|TWO_SIDED|95.0|6.91|37.72|||Cochran-Mantel-Haenszel|||||37.72|6.91|<0.0001
91757560|NCT03624127|183408518|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0002|TWO_SIDED|95.0|1.51|3.6|||Cochran-Mantel-Haenszel|||||3.60|1.51|0.0002
91757561|NCT03624127|183408519|SUPERIORITY||Odds Ratio (OR)|31.3|||<|0.0001|TWO_SIDED|95.0|4.09|239.36|||Cochran-Mantel-Haenszel|||||239.36|4.09|<0.0001
91757562|NCT03624127|183408520|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|2.07|9.84|||Cochran-Mantel-Haenszel|||||9.84|2.07|<0.0001
91757563|NCT03624127|183408520|SUPERIORITY||Odds Ratio (OR)|39.54|||<|0.0001|TWO_SIDED|95.0|5.29|295.75|||Cochran-Mantel-Haenszel|||||295.75|5.29|<0.0001
91757564|NCT03624127|183408521|SUPERIORITY||Adjusted Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|-12.8|-4.9|||ANCOVA|||||-4.9|-12.8|<0.0001
91757565|NCT03624127|183408522|SUPERIORITY||Odds Ratio (OR)|13.67||||0.0013|TWO_SIDED|95.0|1.77|105.5|||Cochran-Mantel-Haenszel|||||105.50|1.77|0.0013
91757566|NCT03624127|183408522|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1702|TWO_SIDED|95.0|0.76|4.42|||Cochran-Mantel-Haenszel|||||4.42|0.76|0.1702
91757567|NCT03624127|183408523|SUPERIORITY||Odds Ratio (OR)|6.04|||<|0.0001|TWO_SIDED|95.0|3.46|10.53|||Cochran-Mantel-Haenszel|||||10.53|3.46|<0.0001
91757568|NCT03624127|183408524|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1049|TWO_SIDED|95.0|0.73|10.96|||Cochran-Mantel-Haenszel|||||10.96|0.73|0.1049
91757569|NCT03624127|183408525|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.78|<0.0001
91757570|NCT03624127|183408526|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.7|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.70|<0.0001
91757571|NCT03624127|183408527|SUPERIORITY||Odds Ratio (OR)|11.92|||<|0.0001|TWO_SIDED|95.0|6.69|21.25|||Cochran-Mantel-Haenszel|||||21.25|6.69|<0.0001
91757572|NCT03624127|183408527|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.04|||Cochran-Mantel-Haenszel|||||6.04|2.21|<0.0001
91757573|NCT03624127|183408528|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.16|4.83|||Cochran-Mantel-Haenszel|||||4.83|2.16|<0.0001
91757574|NCT03624127|183408529|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.53|5.6|||Cochran-Mantel-Haenszel|||||5.60|2.53|<0.0001
91757575|NCT03624127|183408530|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.71|4.05|||Cochran-Mantel-Haenszel|||||4.05|1.71|<0.0001
91757576|NCT03624127|183408531|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.96|4.69|||Cochran-Mantel-Haenszel|||||4.69|1.96|<0.0001
91757577|NCT03624127|183408532|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.0001|TWO_SIDED|95.0|2.06|4.69|||Cochran-Mantel-Haenszel|||||4.69|2.06|<0.0001
91757578|NCT03624127|183408533|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0002|TWO_SIDED|95.0|1.55|4.19|||Cochran-Mantel-Haenszel|||||4.19|1.55|0.0002
91757579|NCT00006400|183408546|SUPERIORITY|The primary analysis was done using an intention-to-treat principle.||||||0.21||||||The spleen endpoint was to be tested at an overall alpha = 0.04. Originally there was a second primary outcome to be tested at alpha = 0.01, but this outcome was dropped.|Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or decreased to absent) and not worsening (from decreased to decreased, normal to normal, or decreased to normal) as measured by splenic uptake on a technetium-99m (99mTc) sulfur colloid liver-spleen scan. Children with missing data or absent spleen function at baseline were excluded from the analysis (26 subjects from hydroxyurea and 23 subjects from placebo group were excluded).||||0.21
91757580|NCT00006400|183408547|SUPERIORITY|||||||0.93||||||This was originally a second primary outcome to be tested at alpha = 0.01, but was later dropped from the protocol. We analyzed the available data.|ANOVA|||The change from baseline to exit as measured by DTPA GFR were compared between treatment groups.||||0.93
91757581|NCT00006400|183408548|SUPERIORITY|||||||0.43||||||All secondary outcomes were tested at alpha=0.01|ANOVA|||The change from baseline to exit as measured by GFR (calculated using Shwartz formula) were compared between treatment groups.||||0.43
91757582|NCT00006400|183408549|SUPERIORITY|||||||0.48||||||All secondary outcomes were to be tested at alpha = 0.01|ANOVA|||The change in GFR from baseline to exit were compared between treatment groups. GFR was calculated using new Schwartz formula.||||0.48
91757583|NCT00666224|183408550|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.55||||0.0005|TWO_SIDED|95.0|0.4|0.77||Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.|Regression, Cox|||||0.77|0.40|0.0005
91757584|NCT00666224|183408551|SUPERIORITY_OR_OTHER||Rate ratio|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.61|||Quasi-Likelihood NB* Regression|"\*NB = Negative Binomial~Center and baseline number of enhancing lesions as covariates."||||0.61|0.29|<0.0001
91757585|NCT00666224|183408552|SUPERIORITY_OR_OTHER||Geometric means ratio|0.87||||0.0013|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.||||0.95|0.79|0.0013
91757586|NCT00666224|183408555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.27|0.61||Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.|Regression, Logistic|||||0.61|0.27|<0.0001
91757587|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.14|||||TWO_SIDED|95.0|0.95|1.37||||||Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).||1.37|0.95|
91757588|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.88|
91757589|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.78|
91757590|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.77|
91757591|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|1.03|1.5||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.50|1.03|
91757592|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.85|
91757593|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.82|1.17||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.82|
91757594|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.93|
91757595|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.27|0.90|
91757596|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.07|0.72|
91757597|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.81|
91757598|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.81|
91757599|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.72|1.16||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.72|
91757600|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.19|||||TWO_SIDED|95.0|1.0|1.4||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.40|1.00|
91757601|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.36|0.91|
91757602|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.29|||||TWO_SIDED|95.0|1.03|1.6||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.60|1.03|
91757603|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.33||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.88|
91757604|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.91|1.46||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.46|0.91|
91757605|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.87|1.43||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.43|0.87|
91757606|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.30|0.83|
91757607|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.21|||||TWO_SIDED|95.0|1.01|1.46||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.46|1.01|
91757608|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.96|
91757609|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.22|0.82|
91757610|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.31|0.89|
91757611|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.69|1.16|
91757612|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.94|1.35||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.35|0.94|
91757613|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.81|1.16||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.81|
91757614|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.87|
91757615|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.94|
91534125|NCT02162446|182945855|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.813
91534126|NCT02162446|182945855|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
91534127|NCT02162446|182945855|OTHER|||||||0.469|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.469
91534128|NCT02162446|182945856|OTHER|||||||0.91|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.910
91534129|NCT02162446|182945856|OTHER|||||||0.039|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.039
91757616|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.13|0.75|
91757617|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.20|0.86|
91757618|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
91757619|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.78|
91757620|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.83|
91534130|NCT02162446|182945856|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
91534131|NCT02162446|182945856|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
91534132|NCT01474538|182945941|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.|LS Mean difference|0.1|||||TWO_SIDED|95.0|-0.002|0.21|||Mixed Models Analysis|||||0.210|-0.002|
91534133|NCT01474538|182945942|SUPERIORITY_OR_OTHER||LS Mean difference|-0.28|||||TWO_SIDED|95.0|-2.92|2.35|||Mixed Models Analysis|||||2.35|-2.92|
91534134|NCT01474538|182945943|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.94||||0.522|||||||Negative binomial|||||||0.522
91534135|NCT01474538|182945944|SUPERIORITY_OR_OTHER||LS Mean difference|-0.58||||0.216|||||||Grizzle Model|||||||0.216
91534136|NCT01474538|182945945|SUPERIORITY_OR_OTHER|||||||0.471|||||||Prescott test|||||||0.471
91757621|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.87|1.3||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.30|0.87|
91757622|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.24|0.80|
91757623|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.94|1.42||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.42|0.94|
91757624|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.33||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.82|
91757625|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.77|1.26||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.77|
91757626|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.82|1.29||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.29|0.82|
91757627|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.28||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.28|0.89|
91757628|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.24||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.95|
91757629|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.85|1.27||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.27|0.85|
91757630|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.41|0.96|
91757631|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.93|1.36||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.36|0.93|
91757632|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.33|0.93|
91757633|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.83|1.19||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.19|0.83|
91757634|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.12||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.78|
91511714|NCT01196871|182895256|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.025|||||TWO_SIDED|90.0|0.921|1.14|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.140|0.921|
91513563|NCT03029208|182898975|SUPERIORITY||LS mean difference|-3.03||||0.8765|TWO_SIDED|95.0|-8.19|2.12|||MMRM||Shortness of breath, no activity: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.12|-8.19|0.8765
91513564|NCT03029208|182898975|SUPERIORITY||LS mean difference|-4.27||||0.9464|TWO_SIDED|95.0|-9.48|0.94|||MMRM||Severity-short breath, Resting: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.94|-9.48|0.9464
91513565|NCT03029208|182898975|SUPERIORITY||LS mean difference|-5.31||||0.9101|TWO_SIDED|95.0|-13.09|2.47|||MMRM||Difficulty standing for long time: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.47|-13.09|0.9101
91757635|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.24||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.88|
91757636|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.29|0.86|
91757637|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.25|0.91|
91757638|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.79|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.79|
91757639|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.85|1.37||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.37|0.85|
91757640|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.98|0.70|
91757641|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
91757642|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.96|0.62|
91757643|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.31|0.87|
91757644|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.15|0.71|
91534137|NCT00367237|182945946|SUPERIORITY_OR_OTHER||Difference in percentages of respondents|19.61||||0.021||95.0|3.27|35.95||Comparison of treatments (IFX + MTX versus MTX)|Chi-squared||Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)|||35.95|3.27|0.0210
91511715|NCT01196871|182895256|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects mode Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.256|||||TWO_SIDED|90.0|1.026|1.538|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.538|1.026|
91511716|NCT01196871|182895258|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.034|||||TWO_SIDED|90.0|0.929|1.152|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.152|0.929|
91511717|NCT01196871|182895258|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.063|||||TWO_SIDED|90.0|0.972|1.164|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.164|0.972|
91511718|NCT01196871|182895260|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.059|||||TWO_SIDED|90.0|0.818|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.818|
91511719|NCT01196871|182895260|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|1.052|||||TWO_SIDED|90.0|0.807|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.807|
91511720|NCT01196871|182895261|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|0.997|||||TWO_SIDED|90.0|0.791|1.259|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.259|0.791|
91511721|NCT03509948|182895274|SUPERIORITY||Geometric Least Squares Mean|79.57|||||TWO_SIDED|90.0|66.4|95.35||||||Fed/Fasted Ratio||95.35|66.40|
91511722|NCT03509948|182895275|SUPERIORITY||Geometric Least Squares Mean|92.08|||||TWO_SIDED|90.0|88.37|95.95||||||Fed/Fasted Ratio||95.95|88.37|
91511723|NCT03509948|182895276|SUPERIORITY||Geometric Least Squares Mean|90.89|||||TWO_SIDED|90.0|84.99|97.2||||||Fed/Fasted Ratio||97.20|84.99|
91511724|NCT03509948|182895278|SUPERIORITY||Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.25|1.75||||||Fed/Fasted Ratio||1.75|0.25|
91511725|NCT03509948|182895280|SUPERIORITY||Geometric Least Squares Mean|91.4|||||TWO_SIDED|90.0|87.55|95.41||||||Fed/Fasted Ratio||95.41|87.55|
91511726|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||||95.0|1.5|1.79|||||Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.79|1.50|
91511727|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||||95.0|1.17|1.41|||||Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.41|1.17|
91511728|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||||95.0|1.59|2.0|||||Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||2.00|1.59|
91511729|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
91534138|NCT00367237|182945946|SUPERIORITY_OR_OTHER||Proportion of Responders|0.863||||||95.0||||||||||||
91534139|NCT00367237|182945946|SUPERIORITY_OR_OTHER||Proportion of Responders|0.667||||||95.0||||||||||||
91534140|NCT02501629|182945950|SUPERIORITY||Odds Ratio (OR)|1.23||||0.468|TWO_SIDED|95.0|0.702|2.157||Significance at 0.05.|proportional odds model|factors for treatment group and randomization strata (age and OCS dose); baseline OCS dose and duration of OCS use prior to study were covariates.||The proportional odds ratio (reslizumab/placebo) was estimated from this model, representing the ratio of the odds of a patient outcome being in a higher OCS dose reduction category for reslizumab compared to placebo.||2.157|0.702|0.468
91757645|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.69|
91757646|NCT03828617|183408575|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.79|1.24||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.79|
91511730|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||||95.0|1.41|1.94|||||Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.94|1.41|
91511731|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||||95.0|1.26|1.76|||||Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.76|1.26|
91511732|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||||95.0|1.23|1.57|||||Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.57|1.23|
91511733|NCT01331694|182895283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
91511734|NCT00508742|182895292|SUPERIORITY_OR_OTHER||Rate Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.65||||||||0.65|0.47|
91511735|NCT00508742|182895293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.5|0.9||||||Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.9|0.5|
91511736|NCT00508742|182895293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.4|0.7||||||Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
91757647|NCT03354273|183408579|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Sensitivity||||<0.0001
91757648|NCT03354273|183408579|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0182|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Specificity||||0.0182
91757649|NCT03354273|183408579|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Sensitivity||||<0.0001
91757650|NCT03354273|183408579|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0002|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Specificity||||0.0002
91757651|NCT03354273|183408579|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Sensitivity||||<0.0001
91757652|NCT03354273|183408579|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.997|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Specificity||||0.9970
91511737|NCT00508742|182895293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.3|0.5||||||Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.5|0.3|
91511738|NCT00508742|182895293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.7||||||Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
91511739|NCT00508742|182895293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.8||||||Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.8|0.4|
91511740|NCT00320281|182895322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANCOVA|||||||0.432
91511741|NCT02312310|182895363|SUPERIORITY|Test of trend across doses.||||||0.393|||||||Mixed Models Analysis|Change in outcome from baseline to 12 weeks tested using mixed effects models controlling for baseline measures, treatment, sex, age, and education.|||The flavanol effect on the change in each outcome from baseline to 12 weeks was tested using linear mixed effects models controlling for the respective baseline measures, four categories of treatment, sex, age, and education. Regression adjusted mean within-group tests of change were estimated and tested for statistical significance from the model. The primary test used for assessing the treatment effect was the linear trend contrast from the model across: placebo, low, medium and high dose. The model for cognitive measures incorporated additional outcome measurement times at 4 weeks and 20 weeks and included categorical time (4, 12, 20 weeks) as a predictor as well as a treatment (4 category) by time interaction, and a random intercept to control for repeated measures within individuals (results for 4 and 20 weeks not presented).|||.393
91511742|NCT00812812|182895368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.198|TWO_SIDED|95.0|-11.7|2.5|||ANCOVA||Mean difference was estimated as paroxetine minus placebo.|||2.5|-11.7|0.198
91511743|NCT02114892|182895373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
91511744|NCT02114892|182895374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
91511745|NCT02114892|182895375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.070
91511746|NCT02114892|182895376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338|||||||Wilcoxon (Mann-Whitney)|||||||0.338
91511747|NCT02114892|182895377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
91511748|NCT02114892|182895378|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91511749|NCT02114892|182895379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|||||||Wilcoxon (Mann-Whitney)|||||||0.083
91511750|NCT02114892|182895380|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91511751|NCT02114892|182895381|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91511752|NCT02114892|182895382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.946|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.946
91511753|NCT02114892|182895383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.365
91511754|NCT02114892|182895384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.557
91511755|NCT02114892|182895385|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91511756|NCT02114892|182895386|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91511757|NCT02114892|182895387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
91757653|NCT03354273|183408579|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Sensitivity||||<0.0001
91757654|NCT03354273|183408579|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0781|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Specificity||||0.0781
91757655|NCT03354273|183408580|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|14.5|||<|0.0001|TWO_SIDED|95.0|6.5|22.4|||McNemar|The hypothesis tests were 1-sided McNemar's tests with a significance level of 0.025 for sensitivity.||Reader 1: Sensitivity||22.4|6.5|<0.0001
91757656|NCT03354273|183408580|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.4||||0.0004|TWO_SIDED|95.0|-4.9|9.7|||Nam's RMLE|||Reader 1: Specificity||9.7|-4.9|0.0004
91757657|NCT03354273|183408580|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.9||||0.0002|TWO_SIDED|95.0|4.7|21.0|||McNemar|||Reader 2: Sensitivity||21.0|4.7|0.0002
91511758|NCT04327934|182895410|EQUIVALENCE|We compared groups across treatments||||||0.018|||||||ANOVA|||||||0.018
91511759|NCT04327934|182895411|EQUIVALENCE|We compared across groups and within groups over time.|||||<|0.016|||||||ANOVA|||||||<0.016
91511760|NCT04327934|182895411|EQUIVALENCE|We compared across groups and within groups over time.||||||0.08|||||||ANOVA|||||||0.08
91511761|NCT04327934|182895414|OTHER|||||||0.05||||||Friedman's tests to compare slopes|Friedman's test|||||||0.05
91511762|NCT04327934|182895416|OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
91511763|NCT04327934|182895416|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
91511764|NCT04327934|182895417|EQUIVALENCE|We compared groups across treatments||||||0.0023|||||||ANOVA|||||||0.0023
91511765|NCT04327934|182895418|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
91511766|NCT04327934|182895419|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
91511767|NCT02443298|182895420|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0255|TWO_SIDED|80.0|1.18|1.81|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.81|1.18|0.0255
91511768|NCT02443298|182895421|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0131|TWO_SIDED|80.0|1.2|1.79|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.79|1.20|0.0131
91511769|NCT02443298|182895422|SUPERIORITY||Rate Ratio|1.4937|STANDARD_ERROR_OF_MEAN|0.22||0.0065|TWO_SIDED|80.0|1.2366|1.8044|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.8044|1.2366|0.0065
91511770|NCT02443298|182895423|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4619|TWO_SIDED|80.0|0.88|1.57|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|Time to first event is obtained from fitting a Cox proportional-hazards model including treatment, and OCS use at baseline as covariate||1.57|0.88|0.4619
91511771|NCT02443298|182895424|SUPERIORITY||Rate Ratio|1.1317|STANDARD_ERROR_OF_MEAN|0.237||0.555|TWO_SIDED|80.0|0.8652|1.4803|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.4803|0.8652|0.5550
91511772|NCT02443298|182895425|SUPERIORITY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.051||0.4423|TWO_SIDED|80.0|-0.104|0.026|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||0.026|-0.104|0.4423
91511773|NCT02443298|182895426|SUPERIORITY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.045||0.1377|TWO_SIDED|80.0|-0.126|-0.009|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||-0.009|-0.126|0.1377
91511774|NCT02443298|182895427|SUPERIORITY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.115||0.1985|TWO_SIDED|80.0|0.0|0.297|||ANCOVA||Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.||0.297|0.000|0.1985
91511775|NCT03095417|182895428|SUPERIORITY|||||||0.747|||||||Mixed Models Analysis|||||||0.747
91511776|NCT03095417|182895429|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
91511777|NCT03095417|182895430|SUPERIORITY|||||||0.264|||||||Mixed Models Analysis|||||||0.264
91511778|NCT03095417|182895431|SUPERIORITY|||||||0.511|||||||Mixed Models Analysis|||||||0.511
91511779|NCT03095417|182895432|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
91511780|NCT03095417|182895433|SUPERIORITY|||||||0.815|||||||Mixed Models Analysis|||||||0.815
91511781|NCT03095417|182895434|SUPERIORITY|||||||0.719|||||||Mixed Models Analysis|||||||0.719
91511782|NCT03095417|182895435|SUPERIORITY|||||||0.346|||||||Mixed Models Analysis|||||||0.346
91511783|NCT03095417|182895436|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.910
91511784|NCT03095417|182895437|SUPERIORITY|||||||0.794|||||||Mixed Models Analysis|||||||0.794
91511785|NCT03095417|182895438|SUPERIORITY|||||||0.626|||||||Mixed Models Analysis|||||||0.626
91511786|NCT03095417|182895439|SUPERIORITY|||||||0.774|||||||Mixed Models Analysis|||||||0.774
91757658|NCT03354273|183408580|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|4.9|||<|0.0001|TWO_SIDED|95.0|-2.1|11.8|||Nam's RMLE|||Reader 2: Specificity||11.8|-2.1|<0.0001
91757659|NCT03354273|183408580|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.3|||<|0.0001|TWO_SIDED|95.0|6.6|19.9|||McNemar|||Reader 3: Sensitivity||19.9|6.6|<0.0001
91511787|NCT02571452|182895440|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.53||0.021|TWO_SIDED|95.0|-6.65|-0.55||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-0.55|-6.65|.021
91511788|NCT02571452|182895441|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.57||0.568|TWO_SIDED|95.0|-1.26|2.3||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||2.30|-1.26|.568
91511789|NCT02571452|182895442|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-5.87|-2.33||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-2.33|-5.87|<.001
91511790|NCT02571452|182895443|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.49||0.173|TWO_SIDED|95.0|-1.61|0.29||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||0.29|-1.61|.173
91511791|NCT03161314|182895448|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Baseline||||0.660
91511792|NCT03161314|182895448|SUPERIORITY|||||||0.734|||||||t-test, 2 sided|||2 weeks after the intervention||||0.734
91511793|NCT03161314|182895448|SUPERIORITY|||||||0.629|||||||t-test, 2 sided|||4 weeks after the intervention||||0.629
91511794|NCT03161314|182895448|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||1-month follow-up||||0.752
91511795|NCT03161314|182895448|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||2-month follow-up||||0.512
91511796|NCT03161314|182895448|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91511797|NCT03161314|182895448|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91511798|NCT03161314|182895449|SUPERIORITY|||||||0.128|||||||t-test, 2 sided|||Baseline||||0.128
91511799|NCT03161314|182895449|SUPERIORITY|||||||0.889|||||||t-test, 2 sided|||2 weeks after the intervention||||0.889
91511800|NCT03161314|182895449|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||4 weeks after the intervention||||0.793
91511801|NCT03161314|182895449|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|||1-month follow-up||||0.602
91511802|NCT03161314|182895449|SUPERIORITY|||||||0.574|||||||t-test, 2 sided|||2-month follow-up||||0.574
91511803|NCT03161314|182895449|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91511804|NCT03161314|182895449|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91511805|NCT03161314|182895450|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||Baseline||||0.374
91511806|NCT03161314|182895450|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||2 weeks after the intervention||||0.674
91511807|NCT03161314|182895450|SUPERIORITY|||||||0.781|||||||t-test, 2 sided|||4 weeks after the intervention||||0.781
91511808|NCT03161314|182895450|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||1-month follow-up||||0.778
91511809|NCT03161314|182895450|SUPERIORITY|||||||0.727|||||||t-test, 2 sided|||2-month follow-up||||0.727
91511810|NCT03161314|182895450|SUPERIORITY|||||||0.014|||||||ANOVA|||Within group comparison||||0.014
91511811|NCT03161314|182895450|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
91511812|NCT03161314|182895451|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline||||0.390
91511813|NCT03161314|182895451|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||2 weeks after the intervention||||0.770
91511814|NCT03161314|182895451|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||4 weeks after the intervention||||0.603
91511815|NCT03161314|182895451|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||1-month follow-up||||0.922
91511816|NCT03161314|182895451|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||2-month follow-up||||0.560
91511817|NCT03161314|182895451|SUPERIORITY|||||||0.181|||||||ANOVA|||Within group comparison||||0.181
91511818|NCT03161314|182895451|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91511819|NCT03161314|182895452|SUPERIORITY|||||||0.334|||||||t-test, 2 sided|||Baseline||||0.334
91511820|NCT03161314|182895452|SUPERIORITY|||||||0.766|||||||t-test, 2 sided|||2 weeks after the intervention||||0.766
91511821|NCT03161314|182895452|SUPERIORITY|||||||0.598|||||||t-test, 2 sided|||4 weeks after the intervention||||0.598
91511822|NCT03161314|182895452|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||1-month follow-up||||0.682
91511823|NCT03161314|182895452|SUPERIORITY|||||||0.707|||||||t-test, 2 sided|||2-month follow-up||||0.707
91511824|NCT03161314|182895452|SUPERIORITY|||||||0.008|||||||ANOVA|||Within group comparison||||0.008
91511825|NCT03161314|182895452|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
91511826|NCT03161314|182895453|SUPERIORITY|||||||0.287|||||||t-test, 2 sided|||Baseline||||0.287
91511827|NCT03161314|182895453|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||2 weeks after the intervention||||0.861
91511828|NCT03161314|182895453|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||4 weeks after the intervention||||0.641
91511829|NCT03161314|182895453|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||1-month follow-up||||0.864
91511830|NCT03161314|182895453|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||2-month follow-up||||0.888
91511831|NCT03161314|182895453|SUPERIORITY|||||||0.262|||||||ANOVA|||Within group comparison||||0.262
91511832|NCT03161314|182895453|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91757660|NCT03354273|183408580|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|1.2||||0.0011|TWO_SIDED|95.0|-6.0|8.4|||Nam's RMLE|||Reader 3: Specificity||8.4|-6.0|0.0011
91511833|NCT03698773|182895464|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
91511834|NCT03698773|182895465|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91511835|NCT01260922|182895487|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.16|||||TWO_SIDED|90.0|97.07|107.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.51|97.07|
91511836|NCT01260922|182895488|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|94.75|||||TWO_SIDED|90.0|92.11|97.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||97.46|92.11|
91511837|NCT04165291|182895490|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<.01
91511838|NCT04165291|182895491|OTHER|||||||0.08|||||||ANOVA|||||||.08
91511839|NCT04165291|182895492|SUPERIORITY|||||||0.116|||||||Repeated Measures Analysis of Variance|||||||.116
91511840|NCT04165291|182895493|SUPERIORITY||Mean Difference (Final Values)|5.146|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
91511841|NCT04165291|182895494|SUPERIORITY|||||||0.13|||||||ANOVA|||||||.13
91511842|NCT04165291|182895495|SUPERIORITY|||||||0.35|||||||ANOVA|||||||.35
91511843|NCT01599650|182895502|SUPERIORITY_OR_OTHER||difference in LS mean|10.0|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|7.3|12.8|||ANOVA|||||12.8|7.3|<0.0001
91511844|NCT01599650|182895502|SUPERIORITY_OR_OTHER||difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|5.8|11.6|||ANOVA|||||11.6|5.8|<0.0001
91511845|NCT01731171|182895513|OTHER|The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.|Cox Proportional Hazard|0.37|||=|0.029|TWO_SIDED|95.0|||||Regression, Logistic||Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.|||||=.029
91511846|NCT01731171|182895514|SUPERIORITY||||||=|0.022|||||||Chi-squared|||||||=.022
91511847|NCT01731171|182895515|SUPERIORITY||||||=|0.009|||||||Regression, Linear|||||||=.009
91511848|NCT01731171|182895516|SUPERIORITY||||||=|0.017|||||||Kruskal-Wallis|||||||=.017
91511849|NCT01410110|182895517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|4.41||0.55|TWO_SIDED|95.0|-11.57|6.25||a prior threshold p \< .05|t-test, 2 sided|df = 40||t-test for equality of means||6.25|-11.57|.55
91535626|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3396|TWO_SIDED|95.0|-0.06|0.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.18|-0.06|0.3396
91511850|NCT01410110|182895518|SUPERIORITY_OR_OTHER||Slope|0.162|STANDARD_ERROR_OF_MEAN|0.94||0.86|TWO_SIDED|95.0|-1.73|2.05||Time X Condition|Mixed Models Analysis|Mixed Models allows for all randomized participants (N=48) to be included in the model.||F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition||2.05|-1.73|.86
91511851|NCT01410110|182895519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.31|TWO_SIDED|95.0|-7.36|2.39||a priori threshold p \< .05|t-test, 2 sided|||||2.39|-7.36|<.31
91511852|NCT01410110|182895520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.952||0.87|TWO_SIDED|95.0|-1.77|2.08||a priori threshold p \< .05|t-test, 2 sided|df=39||||2.08|-1.77|.87
91511853|NCT01410110|182895521|SUPERIORITY_OR_OTHER||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.84||0.67|TWO_SIDED|95.0|-2.07|1.33|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)||1.33|-2.07|.67
91511854|NCT01410110|182895522|SUPERIORITY_OR_OTHER||Slope|-0.42|STANDARD_ERROR_OF_MEAN|0.62||0.5|TWO_SIDED|95.0|-1.67|0.83|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)||.83|-1.67|.50
91757661|NCT03354273|183408580|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.6||||0.0003|TWO_SIDED|95.0|4.1|19.2|||McNemar|||Majority Rule: Sensitivity||19.2|4.1|0.0003
91757662|NCT03354273|183408580|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.1||||0.0004|TWO_SIDED|95.0|-5.0|9.3|||Nam's RMLE|||Majority Rule: Specificity||9.3|-5.0|0.0004
91757663|NCT03354273|183408581|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|24.4||||0.0127|TWO_SIDED|95.0|5.4|43.4|||McNemar|||Reader 1: Sensitivity||43.4|5.4|0.0127
91757664|NCT03354273|183408581|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.5||||0.0001|TWO_SIDED|95.0|-1.2|20.2|||Nam's RMLE|||Reader 1: Specificity||20.2|-1.2|0.0001
91757665|NCT03354273|183408581|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|22.0||||0.0195|TWO_SIDED|95.0|2.2|41.7|||McNemar|||Reader 2: Sensitivity||41.7|2.2|0.0195
91757666|NCT03354273|183408581|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.2|16.8|||Nam's RMLE|||Reader 2: Specificity||16.8|-3.2|0.0004
91757667|NCT03354273|183408581|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|17.1||||0.0174|TWO_SIDED|95.0|1.7|32.4|||McNemar|||Reader 3: Sensitivity||32.4|1.7|0.0174
91757668|NCT03354273|183408581|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|0.7||||0.024|TWO_SIDED|95.0|-9.9|11.3|||Nam's RMLE|||||11.3|-9.9|0.0240
91511855|NCT01410110|182895523|SUPERIORITY_OR_OTHER||Slope|1.16|STANDARD_ERROR_OF_MEAN|0.42||0.008|TWO_SIDED|95.0|0.32|2.01|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,70.15)||2.01|.32|.008
91757669|NCT03354273|183408581|SUPERIORITY||Difference between PET MPI and SPECT MPI|17.1||||0.0448|TWO_SIDED|95.0|-1.5|35.6|||McNemar|||Majority Rule: Sensitivity||35.6|-1.5|0.0448
91757670|NCT03354273|183408581|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.4|17.0|||Nam's RMLE|||Majority Rule: Specificity||17.0|-3.4|0.0004
91757671|NCT03354273|183408582|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.0||||0.0116|TWO_SIDED|95.0|0.0|23.9|||McNemar|||Reader 1: Sensitivity||23.9|0.0|0.0116
91757672|NCT03354273|183408582|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.6||||0.0003|TWO_SIDED|95.0|-2.9|16.2|||Nam's RMLE|||Reader 1: Specificity||16.2|-2.9|0.0003
91757673|NCT03354273|183408582|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.8||||0.1085|TWO_SIDED|95.0|-5.2|18.9|||McNemar|||Reader 2: Sensitivity||18.9|-5.2|0.1085
91757674|NCT03354273|183408582|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.6|||<|0.0001|TWO_SIDED|95.0|2.1|21.1|||Nam's RMLE|||Reader 2: Specificity||21.1|2.1|<0.0001
91757675|NCT03354273|183408582|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.7||||0.0017|TWO_SIDED|95.0|3.8|23.5|||McNemar|||Reader 3: Sensitivity||23.5|3.8|0.0017
91757676|NCT03354273|183408582|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.8||||0.0034|TWO_SIDED|95.0|-6.6|12.1|||Nam's RMLE|||Reader 3: Specificity||12.1|-6.6|0.0034
91534141|NCT02501629|182945951|SUPERIORITY||Odds Ratio (OR)|1.45||||0.234|TWO_SIDED|95.0|0.786|2.683||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.683|0.786|0.234
91534142|NCT02501629|182945952|SUPERIORITY||Odds Ratio (OR)|1.19||||0.596|TWO_SIDED|95.0|0.631|2.229||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.229|0.631|0.596
91534143|NCT02501629|182945953|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|10.759||0.101|TWO_SIDED|95.0|-38.986|3.494|||mixed model repeated measures (MMRM)||Reslizumab - Placebo|Mixed model repeated measures (MMRM) with fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.||3.494|-38.986|0.101
91534144|NCT02501629|182945954|SUPERIORITY||Odds Ratio (OR)|1.36||||0.341|TWO_SIDED|95.0|0.722|2.562||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.562|0.722|0.341
91534145|NCT02501629|182945955|SUPERIORITY||CAE rate ratio|0.82||||0.407|TWO_SIDED|95.0|0.504|1.321|||Negative binomial regression model|Negative binomial regression model adjusted for stratification factors (OCS dose group), age, number of prior exacerbations, and an offset variable.|reslizumab vs placebo|||1.321|0.504|0.407
91757677|NCT03354273|183408582|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|7.7||||0.0641|TWO_SIDED|95.0|-3.6|19.0|||McNemar|||Majority Rule: Sensitivity||19.0|-3.6|0.0641
91757678|NCT03354273|183408582|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|5.0||||0.001|TWO_SIDED|95.0|-4.6|14.6|||Nam's RMLE|||Majority Rule: Specificity||14.6|-4.6|0.0010
91757679|NCT03354273|183408583|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.0||||0.0294|TWO_SIDED|95.0|-2.6|24.6|||McNemar|||Reader 1: Sensitivity||24.6|-2.6|0.0294
91757680|NCT03354273|183408583|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|3.9||||0.0117|TWO_SIDED|95.0|-8.3|16.1|||Nam's RMLE|||Reader 1: Specificity||16.1|-8.3|0.0117
91757681|NCT03354273|183408583|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.6||||0.1444|TWO_SIDED|95.0|-7.1|20.3|||McNemar|||Reader 2: Sensitivity||20.3|-7.1|0.1444
91757682|NCT03354273|183408583|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.7||||0.0001|TWO_SIDED|95.0|-0.4|23.7|||Nam's RMLE|||Reader 2: Specificity||23.7|-0.4|0.0001
91757683|NCT03354273|183408583|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|8.8||||0.044|TWO_SIDED|95.0|-1.3|18.9|||McNemar|||Reader 3: Sensitivity||18.9|-1.3|0.0440
91757684|NCT03354273|183408583|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|7.8||||0.0022|TWO_SIDED|95.0|-4.8|20.3|||Nam's RMLE|||Reader 3: Specificity||20.3|-4.8|0.0022
91757685|NCT03354273|183408583|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|4.4||||0.2164|TWO_SIDED|95.0|-8.4|17.2|||McNemar|||Majority Rule: Sensitivity||17.2|-8.4|0.2164
91757686|NCT03354273|183408583|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.7||||0.0006|TWO_SIDED|95.0|-2.6|22.0|||Nam's RMLE|||Majority Rule: Specificity||22.0|-2.6|0.0006
91757687|NCT00303485|183408584|SUPERIORITY_OR_OTHER||Difference in median|-64.2|||<|0.0001|TWO_SIDED|95.0|-80.28|-46.21|||Wilcoxon rank sum test|||||-46.21|-80.28|< 0.0001
91511856|NCT01410110|182895524|SUPERIORITY_OR_OTHER||Slope|2.025|STANDARD_ERROR_OF_MEAN|0.93||0.03|TWO_SIDED|95.0|0.169|3.93|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,37.8)||3.93|.169|.03
91511857|NCT01410110|182895525|SUPERIORITY_OR_OTHER||Slope|3.86|STANDARD_ERROR_OF_MEAN|2.77||0.17|TWO_SIDED|95.0|-1.73|9.46||a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.|Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)||9.46|-1.73|.17
91511858|NCT01700946|182895526|SUPERIORITY|||||||0.035|||||||Log Rank|||||||0.035
91511859|NCT01700946|182895527|SUPERIORITY|||||||0.105|||||||Log Rank|||||||0.105
91511860|NCT01700946|182895528|SUPERIORITY|||||||0.1181|||||||Fisher Exact|||||||0.1181
91511861|NCT00684424|182895533|SUPERIORITY_OR_OTHER_LEGACY||R-ratio|-56.723|STANDARD_DEVIATION|46.9499||||95.0|||||summary statistic|||R-ratio of seizure frequency summaries = \[(t-b)/(t+b)\]\*100; where t= treatment seizure frequency and b= baseline seizure frequency.||||
91511862|NCT01649856|182895544|SUPERIORITY_OR_OTHER||Difference in Response Rates|8.2||||0.076||95.0|-1.1|17.5|||Chi-squared|||||17.5|-1.1|0.076
91511863|NCT00835406|182895560|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-36 and Rmax at the α level of 0.05.|Ratio of the mean|97.94||||||90.0|90.96|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.45|90.96|
91511864|NCT00835406|182895561|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-35 and Rmax at the α level of 0.05.|Ratio of the mean|100.36||||||90.0|92.85|108.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.48|92.85|
91511865|NCT01071512|182895613|OTHER|||||||0.17|||||||Mixed Models Analysis|||Analysis used all available data from subjects, including those who dropped out early.||||0.17
91511866|NCT01071512|182895614|OTHER|||||||0.6|||||||Mixed Models Analysis|||Analysis used all available data||||0.6
91511867|NCT01071512|182895615|OTHER|||||||0.3|||||||Mixed Models Analysis|||Analysis used all available data||||0.3
91511868|NCT01071512|182895616|OTHER|||||||0.02|||||||Mixed Models Analysis|||Analysis used all available data||||0.02
91511869|NCT01071512|182895617|OTHER|||||||0.9|||||||Mixed Models Analysis|||Analysis used all available data||||0.9
91511870|NCT00594256|182895620|SUPERIORITY_OR_OTHER||||||=|0.002||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||=0.002
91511871|NCT00594256|182895621|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.02
91511872|NCT00594256|182895622|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.04
91511873|NCT00594256|182895623|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.8
91511874|NCT00594256|182895624|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||Open label baseline final paired t test||||<0.01
91511875|NCT00853658|182895625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1724|TWO_SIDED|95.0|0.85|1.03|||Regression, Cox|||(superiority)||1.03|0.85|0.1724
91511876|NCT00853658|182895625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4579|TWO_SIDED|95.0|0.85|1.07|||Regression, Cox|||(superiority) Non-Diabetic patients||1.07|0.85|0.4579
91511877|NCT00853658|182895625|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified Non-inferiority margin 1.104 is used.|Hazard Ratio (HR)|0.99||||0.0368|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||||1.10|0.90|0.0368
91511878|NCT00853658|182895625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9118|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||(superiority)||1.10|0.90|0.9118
91511879|NCT02797262|182895629|SUPERIORITY||Mean Difference (Net)|0.02||||0.57|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)||Treatment Difference = Intervention - Control|Compared the IPAM score between two groups.||||0.57
91511880|NCT02797262|182895631|SUPERIORITY||Mean Difference (Net)|-0.02||||0.08|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the intervention period (week 0-16) between two groups.||||0.08
91511881|NCT02797262|182895631|SUPERIORITY||Mean Difference (Net)|-0.02||||0.23|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the post-intervention period (week 16-28) between two groups.||||0.23
91757688|NCT04099511|183408603|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||.693
91757689|NCT04099511|183408604|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||.536
91757690|NCT04099511|183408605|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||.260
91757691|NCT04099511|183408606|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||||||.387
91757692|NCT04099511|183408607|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
91757693|NCT04099511|183408608|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
91757694|NCT04099511|183408609|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
91757695|NCT04099511|183408610|SUPERIORITY|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
91757696|NCT06581094|183408614|SUPERIORITY|||||||0.478||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Normal walk, Left baseline, week 6, and week 12.||||0.478
91757697|NCT06581094|183408614|SUPERIORITY|||||||0.612||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Normal walk, Right baseline, week 6, and week 12.||||0.612
91511882|NCT02797262|182895631|SUPERIORITY||Mean Difference (Net)|-0.73||||0.03|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the plasma HIV RNA levels during week 4-28 between two groups.||||0.03
91511883|NCT04160260|182895638|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|95.17|||||TWO_SIDED|90.0|84.2|107.5|||||A t-test on the natural log-transformed PK parameter AUC(0-48) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg intravenous (IV) omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log Geometric Mean (GM) AUC(0-48) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.98 (0.2091).||107.5|84.2|
91511884|NCT04160260|182895639|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|100.8|||||TWO_SIDED|90.0|88.0|115.5|||||A t-test on the natural log-transformed PK parameter AUC(0-24) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg IV omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log GM AUC(0-24) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.26 (0.1985).||115.5|88.0|
91511885|NCT01227512|182895646|SUPERIORITY_OR_OTHER|||||||0.9495||||||The alpha level was set at 0.05|Generalized Wilcoxon Test|Participants who used rescue therapy within first 7 days of treatment period were censored at time they started the rescue therapy.||||||0.9495
91511886|NCT01227512|182895647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.146||95.0|-0.7|0.11||alpha level was set at 0.05. p-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|Includes factors of treatment, study center and covariate baseline.||||0.11|-0.70|0.1460
91511887|NCT01227512|182895648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.315||95.0|-0.57|0.19|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 24 hours post-dose.||0.19|-0.57|0.3150
91511888|NCT01227512|182895648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5381||95.0|-0.57|0.3|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 72 hours post-dose.||0.30|-0.57|0.5381
91511889|NCT01227512|182895649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.2702||95.0|-0.73|0.21||P-value was derived from a Cochran-Mantel-Haenszel (CMH) row mean scores test.|Cochran-Mantel-Haenszel|||||0.21|-0.73|0.2702
91511890|NCT01227512|182895650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77||||0.0019||95.0|1.43|6.11||P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|||||6.11|1.43|0.0019
91511891|NCT01227512|182895651|SUPERIORITY_OR_OTHER|||||||0.5128||||||p-value was derived from Generalized Wilcoxon test stratified by treatment. Participants who received rescue therapy were censored at the time of receiving rescue therapy.|Generalized Wilcoxon Test|||||||0.5128
91511892|NCT01227512|182895652|SUPERIORITY_OR_OTHER||Relative Risk|1.1||||0.5795||95.0|0.79|1.52||P-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.52|0.79|0.5795
91511893|NCT01227512|182895653|SUPERIORITY_OR_OTHER||Relative Risk|0.33||||0.1568||95.0|0.07|1.65||p-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.65|0.07|0.1568
91511894|NCT02517905|182895693|SUPERIORITY||LSMD|-2.7||||0.8661|TWO_SIDED|95.0|-33.5|28.2|||ANOVA|||||28.2|-33.5|0.8661
91511895|NCT02517905|182895694|SUPERIORITY||LSMD|-4.0||||0.578|TWO_SIDED|95.0|-18.2|10.2|||ANOVA|||||10.2|-18.2|0.5780
91511896|NCT02517905|182895695|SUPERIORITY||LSMD|5.9||||0.801|TWO_SIDED|95.0|-40.2|52.1|||ANOVA|||||52.1|-40.2|0.8010
91511897|NCT00023452|182895699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% confidence interval (CI) was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.24|||||ONE_SIDED|95.0||0.01|||||The difference in cumulative TB disease rate is the rate in the 3RPT/INH arm minus the rate in the 9INH arm.|||0.01||
91511898|NCT00023452|182895700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Rate|-0.21|||||ONE_SIDED|95.0||0.04|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.04||
91513566|NCT03029208|182898975|SUPERIORITY||LS mean difference|-6.52||||0.9586|TWO_SIDED|95.0|-13.9|0.86|||MMRM||Difficulty sleeping: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-13.90|0.9586
91757698|NCT06581094|183408614|SUPERIORITY|||||||0.534|||||||ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Stand up/squat down, Left baseline, week 6, and week 12.||||0.534
91757699|NCT06581094|183408614|SUPERIORITY|||||||0.538|||||||ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Stand up/squat down, Right baseline, week 6, and week 12.||||0.538
91757700|NCT06581094|183408614|SUPERIORITY|||||||0.195||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Bend to biggest angle, Left baseline, week 6, and week 12.||||0.195
91757701|NCT06581094|183408614|SUPERIORITY|||||||0.232||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Bend to biggest angle, Right baseline, week 6, and week 12.||||0.232
91511899|NCT00023452|182895701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.25|||||ONE_SIDED|95.0||0.03|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.03||
91511900|NCT00023452|182895702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Chi-squared|||||||0.02
91511901|NCT00023452|182895703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24||95.0|||||Chi-squared|||Grade 3 Drug Toxicity||||0.24
91511902|NCT00023452|182895703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||Chi-squared|||Grade 4 Drug Toxicity||||0.59
91511903|NCT00023452|182895704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0|||||Chi-squared|||||||0.22
91511904|NCT00023452|182895706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91511905|NCT00023452|182895707|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91511906|NCT00023452|182895708|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.19|||||ONE_SIDED|95.0||0.06|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.06||
91511907|NCT04551105|182895739|SUPERIORITY||different in area under the LROC curve|0.0374|||<|0.05|TWO_SIDED|95.0|0.019|0.0557|||OR-DBM model|||||0.0557|0.0190|<0.05
91511908|NCT04551105|182895740|SUPERIORITY||Mean Difference (Net)|12.78|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91511909|NCT04551105|182895741|SUPERIORITY||different in sensitivity|-0.0013|||<|0.05|TWO_SIDED|95.0|-0.2307|0.2281|||McNemar|||||0.2281|-0.2307|<0.05
91511910|NCT04551105|182895741|SUPERIORITY||different in specificity|0.1065|||<|0.05|TWO_SIDED|95.0|0.0008|0.2122|||McNemar|||||0.2122|0.0008|<0.05
91511911|NCT04551105|182895741|SUPERIORITY||different in PPV|-0.086|||<|0.05|TWO_SIDED|95.0|-0.1824|0.0104|||McNemar|||||0.0104|-0.1824|<0.05
91511912|NCT04551105|182895741|SUPERIORITY||different in NPV|0.086|||<|0.05|TWO_SIDED|95.0|-0.0104|0.1824|||McNemar|||||0.1824|-0.0104|<0.05
91511913|NCT00459134|182895748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.19||0.576|TWO_SIDED|95.0|-1.67|3.0||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||3.00|-1.67|0.576
91511914|NCT00459134|182895749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.49|STANDARD_ERROR_OF_MEAN|1.73||0.01|TWO_SIDED|95.0|1.09|7.89||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||7.89|1.09|0.010
91511915|NCT02276495|182895773|SUPERIORITY|||||||0.668|||||||Kruskal-Wallis|||||||0.668
91511916|NCT02276495|182895774|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
91757702|NCT06581094|183408614|SUPERIORITY|||||||0.369||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Normal walk, Left.||||0.369
91511917|NCT02276495|182895775|SUPERIORITY|||||||0.013|||||||Kruskal-Wallis|||||||0.013
91511918|NCT03047447|182895801|OTHER|||||||0.001||||||Change over time from week 0 to week 10 with HgA1c for experimental ketogenic group vs.control exercise and non-exercise groups.|ANOVA|||||||0.001
91511919|NCT03047447|182895802|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with weight for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
91511920|NCT03047447|182895803|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with BMI for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
91757703|NCT06581094|183408614|SUPERIORITY|||||||0.593||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Normal walk, Right.||||0.593
91534146|NCT02501629|182945956|SUPERIORITY||Odds Ratio (OR)|0.82||||0.628|TWO_SIDED|95.0|0.371|1.818||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||1.818|0.371|0.628
91757704|NCT06581094|183408614|SUPERIORITY|||||||0.918||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stand up/squat down, Left.||||0.918
91757705|NCT06581094|183408614|SUPERIORITY|||||||0.99||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stand up/squat down, Right.||||0.990
91757706|NCT06581094|183408614|SUPERIORITY|||||||0.263||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Bend to biggest angle, Left.||||0.263
91757707|NCT06581094|183408614|SUPERIORITY|||||||0.235||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Bend to biggest angle, Right.||||0.235
91757708|NCT06581094|183408615|SUPERIORITY|||||||0.399||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of up-and-go test on baseline, week 6, and week 12.||||0.399
91757709|NCT06581094|183408615|SUPERIORITY|||||||0.106||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of timed up-and-go test.||||0.106
91757710|NCT06581094|183408616|SUPERIORITY|||||||0.502||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of AROM, Left baseline, week 6, and week 12.||||0.502
91757711|NCT06581094|183408616|SUPERIORITY|||||||0.724||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of AROM, Right baseline, week 6, and week 12.||||0.724
91757712|NCT06581094|183408616|SUPERIORITY|||||||0.414||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of PROM, Left baseline, week 6, and week 12.||||0.414
91757713|NCT06581094|183408616|SUPERIORITY|||||||0.563||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of PROM, Right baseline, week 6, and week 12.||||0.563
91757714|NCT06581094|183408616|SUPERIORITY|||||||0.11||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of AROM, Left.||||0.110
91757715|NCT06581094|183408616|SUPERIORITY|||||||0.245||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of AROM, Right.||||0.245
91757716|NCT06581094|183408616|SUPERIORITY|||||||0.113||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of PROM, Left.||||0.113
91757717|NCT06581094|183408616|SUPERIORITY|||||||0.395||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of PROM, Right.||||0.395
91757718|NCT06581094|183408617|SUPERIORITY|||||||0.823||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Pain on baseline, week 6, and week 12.||||0.823
91757719|NCT06581094|183408617|SUPERIORITY|||||||0.895||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Stiffness on baseline, week 6, and week 12.||||0.895
91511921|NCT03047447|182895804|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with body fat mass for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
91511922|NCT03047447|182895805|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with blood ketones for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
91511923|NCT02669329|182895819|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|72.9|93.4||||||||93.4|72.9|
91511924|NCT01404312|182895830|NON_INFERIORITY|"Non-inferiority margin: 1.25 events per 100 person-years.~Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power."|Incidence Rate Difference|-0.0231|||||TWO_SIDED|95.1|-0.346|0.3|||||"Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).~Incidence rate units: Events per 100 person-years"|Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.||0.300|-0.346|
91511925|NCT01404312|182895831|SUPERIORITY||Risk Difference (RD)|-0.016||||0.073|TWO_SIDED|95.0|-0.035|0.002||Not adjusted for multiple comparisons.|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any SAE occurrence between arms A and B.~H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B."||0.002|-0.035|0.073
91511926|NCT01404312|182895832|SUPERIORITY||Risk Difference (RD)|-0.0058||||0.405|TWO_SIDED|95.0|-0.019|0.007||Not adjusted for multiple comparisons|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.~H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B."||0.007|-0.019|0.405
91511927|NCT01404312|182895833|SUPERIORITY||Odds Ratio (OR)|2.093|||||TWO_SIDED|95.0|1.315|3.332|||||"Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A~Not adjusted for multiple comparisons."|"Odds ratio of being in higher category estimated from proportional odds model~H0: Odds ratio of being in higher category for Arm A vs Arm B = 1"||3.332|1.315|
91511928|NCT01404312|182895834|SUPERIORITY|||||||0.3078||||||Not adjusted for multiple comparisons|Log Rank|||H0: Survival curve Arm A = Survival curve Arm B||||0.3078
91511929|NCT01404312|182895835|SUPERIORITY||Hazard Ratio (HR)|1.396||||0.2802|TWO_SIDED|95.0|0.762|2.559||Not adjusted for multiple comparisons|Hazard Ratio||Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR \> 1 favors arm A|"Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.~H0: Hazard Ratio for Arm A vs Arm B = 1"||2.559|0.762|0.2802
91511930|NCT02451748|182895863|EQUIVALENCE|ANOVA||||||0.5378||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.5378
91511931|NCT02451748|182895863|EQUIVALENCE|ANOVA||||||0.919||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.919
91511932|NCT02451748|182895863|EQUIVALENCE|ANOVA||||||0.4255||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.4255
91511933|NCT02451748|182895863|EQUIVALENCE|ANOVA||||||0.1037||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.1037
91511934|NCT02451748|182895863|EQUIVALENCE|ANOVA||||||0.0008||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.0008
91511935|NCT02451748|182895863|EQUIVALENCE|ANOVA||||||0.0001||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.0001
91511936|NCT00071487|182895864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.3677|TWO_SIDED|95.0|-19.4|7.2||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.2|-19.4|0.3677
91511937|NCT00071487|182895864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.4244|TWO_SIDED|95.0|-8.7|20.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||20.6|-8.7|0.4244
91511938|NCT00071487|182895864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.3296|TWO_SIDED|95.0|-19.6|6.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||6.6|-19.6|0.3296
91511939|NCT00071487|182895865|SUPERIORITY_OR_OTHER|||||||0.6423||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.6423
91513567|NCT03029208|182898976|SUPERIORITY||LS mean difference|0.27||||0.981|TWO_SIDED|95.0|0.02|0.53|||MMRM||MMRM model was fitted from Baseline up to Week 8 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.53|0.02|0.9810
91757720|NCT06581094|183408617|SUPERIORITY|||||||0.682||||||It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05.|ANOVA|||This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Physical function on baseline, week 6, and week 12.||||0.682
91757721|NCT06581094|183408617|SUPERIORITY|||||||0.303||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Pain.||||0.303
91757722|NCT06581094|183408617|SUPERIORITY|||||||0.148||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stiffness.||||0.148
91757723|NCT06581094|183408617|SUPERIORITY|||||||0.283||||||It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05.|ANOVA|||It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Physical function.||||0.283
91757724|NCT05740618|183408619|SUPERIORITY|||||||0.04||||||MCC60 was analyzed using a linear repeated measure model including visit number, skew of the deposition histogram as fixed effects.|Mixed Models Analysis|||||||0.04
91757725|NCT05740618|183408620|SUPERIORITY|||||||0.2||||||T-tests performed as paired analyses using baseline cough clearance.|t-test, 2 sided|||||||0.20
91757726|NCT05740618|183408621|SUPERIORITY|||||||0.07||||||T-tests performed as paired analyses using baseline Mucociliary Clearance (MCC) Over 90 Minutes.|t-test, 2 sided|||||||0.07
91757727|NCT05740618|183408622|SUPERIORITY|||||||0.04||||||T-tests performed as paired analyses using baseline FEV1.|t-test, 2 sided|||||||0.04
91757728|NCT05740618|183408623|SUPERIORITY|||||||0.94||||||T-tests performed as paired analyses using baseline CFQR-R respiratory domain.|t-test, 2 sided|||||||0.94
91757729|NCT05740618|183408624|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|T-tests performed as paired analyses using baseline CFRSD-CRISS.||||||0.13
91757730|NCT02354235|183408656|SUPERIORITY||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.15|-0.6|||ANCOVA|||||-0.60|-1.15|<0.001
91757731|NCT02354235|183408657|SUPERIORITY||Least Squares Mean Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-48.5|-29.2|||ANCOVA|||||-29.2|-48.5|<0.001
91757732|NCT02354235|183408658|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.2|-1.45|||ANCOVA|||||-1.45|-3.20|<0.001
91757733|NCT02354235|183408659|SUPERIORITY||Least Squares Mean Difference|-100.3|STANDARD_ERROR_OF_MEAN|11.1|<|0.001|TWO_SIDED|95.0|-122.2|-78.4|||ANCOVA|||||-78.4|-122.2|<0.001
91757734|NCT02354235|183408660|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-64.9|-36.9|||ANCOVA|||||-36.9|-64.9|<0.001
91757735|NCT03688100|183408676|SUPERIORITY||ratio of means|0.62||||0.005|TWO_SIDED|95.0|0.45|0.86||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 3 MONTHS||0.86|0.45|0.005
91757736|NCT03688100|183408676|SUPERIORITY||ratio of means|0.7||||0.008|TWO_SIDED|95.0|0.6|0.86||The a priori threshold for statistical significance is p\<0.05|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 6 MONTHS||0.86|0.60|0.008
91757737|NCT03688100|183408676|SUPERIORITY||ratio of means|0.73||||0.0001|TWO_SIDED|95.0|0.62|0.85||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits , BA is numerator and MEDS is the denominator.|Emergency Department visits AT 12 MONTHS||0.85|0.62|0.0001
91757738|NCT03688100|183408677|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model|||Differences in the number of hospital readmissions between BA and MEDS at 3, 6, and 12 months||||>0.05
91757739|NCT03688100|183408678|SUPERIORITY||ratio of means|0.83||||0.002|TWO_SIDED|95.0|0.75|0.92||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital at 3 months||0.92|0.75|0.002
91757740|NCT03688100|183408678|SUPERIORITY||ratio of means|0.81||||0.005|TWO_SIDED|95.0|0.75|0.87||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is numerator and MEDS is the denominator.|Days in the Hospital at 6 MONTHS||0.87|0.75|0.005
91757741|NCT03688100|183408678|SUPERIORITY||ratio of means|0.64|||<|0.0001|TWO_SIDED|95.0|0.6|0.68||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital AT 12 MONTHS||0.68|0.60|<0.0001
91534147|NCT00886613|182945986|SUPERIORITY_OR_OTHER||kappa coefficient of agreement|0.85||||0.564|TWO_SIDED|90.0|0.72|0.99|||McNemar||The significance of the difference between the proportion of subjects with a positive skin test at 48 hours and the proportion of subjects with a positive skin test at 72 hours|||0.99|0.72|0.564
91757742|NCT03688100|183408679|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Kaplan Meier survival plots|||||||>0.05
91757743|NCT04783077|183408680|SUPERIORITY||Odds Ratio (OR)|2.28||||0.23|TWO_SIDED|95.0|0.61|8.5|||Regression, Logistic||The estimated odds ratio of return donation attempt represents WhatsApp compared to control.|The primary analysis applies only to the RCT participants (N=130). Docudrama participants were not assessed for return blood donation. Analysis used fitted logistic regression with outcome donation attempted (Y/N) on the modiﬁed intention-to-treat (mITT) population, adjusted for type of donor (FRD, VNRBD).|Missing data on the primary outcome from the mITT analysis was handled using multiple imputation via chained equations with 50 imputations, and included stratum, group assignment (WhatsApp, Control) and ethnicity. Ethnicity was the only baseline variable with a minimum Kendall's tau of 0.2 with donation attempt.|8.50|0.61|0.23
91757744|NCT00439374|183408692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.79|1.35||||||All deliveries less than 37 weeks||1.35|0.79|
91757745|NCT00439374|183408692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.7|1.4||||||Spontaneous deliveries||1.40|0.70|
91757746|NCT00439374|183408692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.65|1.84||||||Medically-indicated deliveries||1.84|0.65|
91757747|NCT00439374|183408693|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
91511940|NCT00071487|182895865|SUPERIORITY_OR_OTHER|||||||0.8536||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.8536
91511941|NCT00071487|182895865|SUPERIORITY_OR_OTHER|||||||0.9705||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.9705
91511942|NCT00071487|182895866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1||||0.1763|TWO_SIDED|95.0|-22.4|4.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||4.1|-22.4|0.1763
91511943|NCT00071487|182895866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.7112|TWO_SIDED|95.0|-20.9|14.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||14.3|-20.9|0.7112
91511944|NCT00071487|182895866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.332|TWO_SIDED|95.0|-22.2|7.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.5|-22.2|0.3320
91511945|NCT00071487|182895867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.6||||0.1287|TWO_SIDED|95.0|-65.6|8.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||8.4|-65.6|0.1287
91511946|NCT00071487|182895867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98||||0.8807|TWO_SIDED|95.0|-36.2|42.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||42.1|-36.2|0.8807
91511947|NCT00071487|182895867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.41||||0.1131|TWO_SIDED|95.0|-68.1|7.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||7.3|-68.1|0.1131
91511948|NCT00071487|182895868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.7823|TWO_SIDED|95.0|-13.8|10.4||P-value was not adjusted for multiple testing|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||10.4|-13.8|0.7823
91511949|NCT00071487|182895868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.1774|TWO_SIDED|95.0|-18.2|3.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||3.4|-18.2|0.1774
91511950|NCT00071487|182895868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.6406|TWO_SIDED|95.0|-14.8|9.1|||t-test, 2 sided|P-value was not adjusted for multiple testing.||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||9.1|-14.8|0.6406
91511951|NCT00071487|182895869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.7822|TWO_SIDED|95.0|-38.6|29.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||29.1|-38.6|0.7822
91511952|NCT00071487|182895869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9||||0.3332|TWO_SIDED|95.0|-45.3|15.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||15.4|-45.3|0.3332
91511953|NCT00071487|182895869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.466|TWO_SIDED|95.0|-46.9|21.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||21.5|-46.9|0.4660
91511954|NCT00071487|182895870|SUPERIORITY_OR_OTHER|||||||0.5615||95.0||||P-value was not adjusted for multiple comparisons.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.5615
91511955|NCT00071487|182895870|SUPERIORITY_OR_OTHER|||||||0.7593||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.7593
91511956|NCT00071487|182895870|SUPERIORITY_OR_OTHER|||||||0.2273||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.2273
91511957|NCT00071487|182895871|SUPERIORITY_OR_OTHER||percent difference from placebo|-7.1||||0.4355|TWO_SIDED|95.0|-24.7|10.6||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||10.6|-24.7|0.4355
91757748|NCT00439374|183408694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.8||||||||1.80|0.61|
91757749|NCT00439374|183408695|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.58|1.21||||||||1.21|0.58|
91757750|NCT00439374|183408696|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.43||||||||1.43|0.54|
91757751|NCT00439374|183408697|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3||||||||1.30|0.36|
91757752|NCT00439374|183408698|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.82|1.15||||||||1.15|0.82|
91757753|NCT00439374|183408699|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.55|1.29||||||||1.29|0.55|
91757754|NCT00439374|183408700|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.77|1.55||||||||1.55|0.77|
91757755|NCT00439374|183408701|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.43|5.33||||||||5.33|0.43|
91757756|NCT00439374|183408702|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.78|1.72||||||||1.72|0.78|
91511958|NCT00071487|182895871|SUPERIORITY_OR_OTHER||percent difference from placebo|4.4||||0.6669|TWO_SIDED|95.0|-15.5|24.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||24.2|-15.5|0.6669
91757757|NCT00439374|183408703|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.56|2.41||||||||2.41|0.56|
91757758|NCT00439374|183408705|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.34|1.58||||||||1.58|0.34|
91757759|NCT00439374|183408706|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.84|2.52||||||||2.52|0.84|
91757760|NCT00439374|183408707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
91757761|NCT00439374|183408708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||Any side effect||1.13|0.92|
91757762|NCT00439374|183408708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.93|1.17||||||Injection site||1.17|0.93|
91757763|NCT00439374|183408708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.03|||||TWO_SIDED|95.0|1.11|22.78||||||Urticaria||22.78|1.11|
91757764|NCT00439374|183408708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.27|1.83||||||Nausea||1.83|0.27|
91757765|NCT00439374|183408709|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.46|1.3||||||Analysis is for the total composite||1.30|0.46|
91757766|NCT00439374|183408710|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
91757767|NCT00439374|183408718|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
91511959|NCT00071487|182895871|SUPERIORITY_OR_OTHER||percent difference from placebo|17.7||||0.0882|TWO_SIDED|95.0|-2.5|37.9||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||37.9|-2.5|0.0882
91757768|NCT04033068|183408719|SUPERIORITY||||||=|0.2003|||||||Fisher-Freeman-Halton Test|||||||= 0.2003
91757769|NCT04033068|183408720|SUPERIORITY||||||=|0.1448|||||||Fisher-Freeman-Halton Test|||||||= 0.1448
91757770|NCT04033068|183408721|SUPERIORITY||||||=|0.9111|||||||Fisher-Freeman-Halton Test|||||||= 0.9111
91757771|NCT04033068|183408722|SUPERIORITY||||||=|1|||||||Fisher-Freeman-Halton Test|||||||= 1.0000
91757772|NCT04033068|183408724|SUPERIORITY||GMT Ratio|0.9|||=|0.999|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 0||5.5|0.2|= 0.9990
91534148|NCT00886613|182945988|SUPERIORITY_OR_OTHER||Difference in proportions|0.06||||0.343|TWO_SIDED|90.0|-0.17|0.28|||Chi-squared||Statistical analysis for dose 2|||0.28|-0.17|0.343
91757773|NCT04033068|183408724|SUPERIORITY||GMT Ratio|0.8|||=|0.9798|TWO_SIDED|95.0|0.1|5.2|||ANOVA|||Day 0||5.2|0.1|= 0.9798
91757774|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.2|||=|0.9958|TWO_SIDED|95.0|0.1|10.1|||ANOVA|||Day 0||10.1|0.1|= 0.9958
91757775|NCT04033068|183408724|SUPERIORITY||GMT Ratio|0.8|||=|0.9935|TWO_SIDED|95.0|0.1|5.5|||ANOVA|||Day 0||5.5|0.1|= 0.9935
91757776|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.3|||=|0.9852|TWO_SIDED|95.0|0.2|10.7|||ANOVA|||Day 0||10.7|0.2|= 0.9852
91757777|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.6|||=|0.944|TWO_SIDED|95.0|0.2|14.4|||ANOVA|||Day 0||14.4|0.2|= 0.9440
91757778|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.2|||=|0.9943|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 28||5.5|0.2|= 0.9943
91757779|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.0|||=|0.9999|TWO_SIDED|95.0|0.2|5.1|||ANOVA|||Day 28||5.1|0.2|= 0.9999
91757780|NCT04033068|183408724|SUPERIORITY||GMT Ratio|2.2|||=|0.6476|TWO_SIDED|95.0|0.4|14.3|||ANOVA|||Day 28||14.3|0.4|= 0.6476
91757781|NCT04033068|183408724|SUPERIORITY||GMT Ratio|0.8|||=|0.9911|TWO_SIDED|95.0|0.2|4.3|||ANOVA|||Day 28||4.3|0.2|= 0.9911
91757782|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.9|||=|0.7647|TWO_SIDED|95.0|0.3|12.0|||ANOVA|||Day 28||12.0|0.3|= 0.7647
91757783|NCT04033068|183408724|SUPERIORITY||GMT Ratio|2.3|||=|0.6447|TWO_SIDED|95.0|0.3|15.8|||ANOVA|||Day 28||15.8|0.3|= 0.6447
91757784|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.3|||=|0.9638|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 56||5.3|0.3|= 0.9638
91757785|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.7|||=|0.7837|TWO_SIDED|95.0|0.4|7.7|||ANOVA|||Day 56||7.7|0.4|= 0.7837
91757786|NCT04033068|183408724|SUPERIORITY||GMT Ratio|2.9|||=|0.3427|TWO_SIDED|95.0|0.5|15.3|||ANOVA|||Day 56||15.3|0.5|= 0.3427
91757787|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.3|||=|0.9578|TWO_SIDED|95.0|0.3|5.8|||ANOVA|||Day 56||5.8|0.3|= 0.9578
91757788|NCT04033068|183408724|SUPERIORITY||GMT Ratio|2.2|||=|0.5637|TWO_SIDED|95.0|0.4|11.7|||ANOVA|||Day 56||11.7|0.4|= 0.5637
91757789|NCT04033068|183408724|SUPERIORITY||GMT Ratio|1.7|||=|0.8471|TWO_SIDED|95.0|0.3|9.6|||ANOVA|||Day 56||9.6|0.3|= 0.8471
91757790|NCT01817959|183408738|SUPERIORITY||least square mean difference|0.001||||0.9863|TWO_SIDED|99.75|-0.205|0.207||Treatment p value|ANOVA|||||0.207|-0.205|0.9863
91757791|NCT01817959|183408739|SUPERIORITY||least square mean difference|0.024||||0.7115|TWO_SIDED|99.75|-0.184|0.232||Treatment p value|ANOVA|||||0.232|-0.184|0.7115
91757792|NCT01817959|183408740|SUPERIORITY||Odds Ratio, log|0.21||||0.1346|TWO_SIDED|95.0|0.03|1.63||Treatment p value|Regression, Logistic|||Analytical statistics are reported for Day 75 after transplant 2||1.63|0.03|0.1346
91757793|NCT01817959|183408741|SUPERIORITY||Odds Ratio (OR)|0.91||||0.913|TWO_SIDED|95.0|0.17|4.93||Treatment p value|Regression, Logistic|||||4.93|0.17|0.9130
91757794|NCT01817959|183408742|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5467|TWO_SIDED|95.0|0.16|2.66||Treatment p value|Regression, Logistic|||||2.66|0.16|0.5467
91757795|NCT01817959|183408743|SUPERIORITY|||||||0.1383|||||||Fisher Exact|||||||0.1383
91757796|NCT01817959|183408745|SUPERIORITY||least square mean difference|-0.021||||0.6952|TWO_SIDED|95.0|-0.13|0.088||Treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 1)||0.088|-0.130|0.6952
91757797|NCT01817959|183408745|SUPERIORITY||least square mean difference|0.028||||0.556|TWO_SIDED|95.0|-0.068|0.124||This is a treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 2)||0.124|-0.068|0.5560
91757798|NCT01817959|183408745|SUPERIORITY||least square mean difference|0.056||||0.2537|TWO_SIDED|95.0|-0.042|0.154||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.154|-0.042|0.2537
91757799|NCT01817959|183408746|SUPERIORITY||least square mean difference|-7.4||||0.591|TWO_SIDED|95.0|-35.2|20.3||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||20.3|-35.2|0.5910
91757800|NCT01817959|183408746|SUPERIORITY||least square mean difference|4.2||||0.5966|TWO_SIDED|95.0|-11.8|20.2||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 75 (Transplant 2)||20.2|-11.8|0.5966
91757801|NCT01817959|183408746|SUPERIORITY||least square mean difference|6.1||||0.5005|TWO_SIDED|95.0|-12.1|24.4||Treatment p value|ANCOVA|||This is the analytic statics for Day 365 (last Transplant)||24.4|-12.1|0.5005
91757802|NCT01817959|183408747|SUPERIORITY||least square mean difference|0.21||||0.3253|TWO_SIDED|95.0|-0.21|0.63||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||0.63|-0.21|0.3253
91757803|NCT01817959|183408747|SUPERIORITY||least square mean difference|0.16||||0.6069|TWO_SIDED|95.0|-0.46|0.78||Treatment p value|least square mean difference|||This is the analytic statics for Day 75 (Transplant 2)||0.78|-0.46|0.6069
91757804|NCT01817959|183408747|SUPERIORITY||Least square mean difference|0.17||||0.6437|TWO_SIDED|95.0|-0.56|0.93||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.93|-0.56|0.6437
91757805|NCT01817959|183408748|SUPERIORITY||least square mean difference|2.0||||0.429|TWO_SIDED|95.0|-3.0|6.9||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 1)||6.9|-3.0|0.4290
91757806|NCT01817959|183408748|SUPERIORITY||least square mean difference|1.0||||0.7853|TWO_SIDED|95.0|-6.3|8.3||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 2)||8.3|-6.3|0.7853
91757807|NCT01817959|183408748|SUPERIORITY||least square mean difference|1.9||||0.6583|TWO_SIDED|95.0|-6.6|10.4||Treatment p value|ANCOVA|||This is the analytic statistics for Day 365 (last Transplant)||10.4|-6.6|0.6583
91757808|NCT01817959|183408752|SUPERIORITY||Least square mean difference|0.0||||0.9949|TWO_SIDED|95.0|-1.28|1.28||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||1.28|-1.28|0.9949
91757809|NCT01817959|183408752|SUPERIORITY||Least square mean difference|0.1||||0.8753|TWO_SIDED|95.0|-1.18|1.38||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||1.38|-1.18|0.8753
91757810|NCT01817959|183408752|SUPERIORITY||Least square mean difference|-0.59||||0.3955|TWO_SIDED|95.0|-1.97|0.8||Treatment p value|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.80|-1.97|0.3955
91757811|NCT01817959|183408753|SUPERIORITY||Least square mean difference|-0.105||||0.2444|TWO_SIDED|95.0|-0.286|0.075||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||0.075|-0.286|0.2444
91757812|NCT01817959|183408753|SUPERIORITY||Least square mean difference|-0.218||||0.0328|TWO_SIDED|95.0|-0.417|-0.019||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||-0.019|-0.417|0.0328
91757813|NCT01817959|183408753|SUPERIORITY||Least square mean difference|-0.177||||0.1059|TWO_SIDED|95.0|-0.393|0.039||This is the analytic statistics for Day 75 (Transplant 2)|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.039|-0.393|0.1059
91757814|NCT00559988|183408795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.064||||0.732|TWO_SIDED|95.0|0.75|1.51|||Regression, Cox|||||1.51|0.75|0.732
91757815|NCT03916484|183408815|OTHER|||||||0.33||||||No a priori threshold for statistical significance was specified.|Kruskal-Wallis|||||||0.33
91757816|NCT03916484|183408816|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91757817|NCT03916484|183408816|OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91757818|NCT03916484|183408816|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91757819|NCT03916484|183408816|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91757820|NCT03916484|183408816|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91757821|NCT03916484|183408817|OTHER|||||||0.45||||||No a priori threshold for statistical significance was specified.|Fisher Exact|||||||0.45
91757822|NCT03916484|183408818|OTHER||||||<|0.001|||||||McNemar|||||||<0.001
91757823|NCT03916484|183408818|OTHER|||||||0.07|||||||McNemar|||||||0.07
91757824|NCT03916484|183408818|OTHER|||||||0.003|||||||McNemar|||||||0.003
91757825|NCT03916484|183408819|OTHER|||||||0.25|||||||McNemar|||||||0.25
91513568|NCT03029208|182898976|SUPERIORITY||LS mean difference|0.05||||0.6743|TWO_SIDED|95.0|-0.17|0.26|||MMRM||MMRM model was fitted from Baseline up to Week 12 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.26|-0.17|0.6743
91757826|NCT03916484|183408819|OTHER|||||||0.002|||||||McNemar|||||||0.002
91757827|NCT03916484|183408819|OTHER|||||||0.453|||||||McNemar|||||||0.453
91757828|NCT03916484|183408819|OTHER|||||||0.5|||||||McNemar|||||||0.500
91757829|NCT03916484|183408819|OTHER|||||||0.003|||||||McNemar|||||||0.003
91757830|NCT04943432|183408820|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||T2 - T1||||0.06
91757831|NCT04943432|183408820|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||T3 - T1||||0.68
91757832|NCT04943432|183408822|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
91757833|NCT04943432|183408822|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||T3-T1||||.32
91757834|NCT04943432|183408823|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||T2-T1||||.44
91757835|NCT04943432|183408823|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||T3-T1||||.007
91757836|NCT04943432|183408827|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
91757837|NCT04943432|183408827|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||T3-T1||||.11
91757838|NCT04943432|183408828|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||T2-T1||||.82
91757839|NCT04943432|183408828|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||T3-T1||||.36
91534149|NCT01124162|182945990|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|108.14|||||TWO_SIDED|90.0|97.43|120.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.03|97.43|
91534150|NCT01124162|182945991|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.7|||||TWO_SIDED|90.0|98.57|104.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.93|98.57|
91534151|NCT01124162|182945992|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.5|||||TWO_SIDED|90.0|98.41|104.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.68|98.41|
91534152|NCT01124162|182945993|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.08|||||TWO_SIDED|90.0|98.24|106.06|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.06|98.24|
91534153|NCT01124162|182945994|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.31|||||TWO_SIDED|90.0|97.84|102.84|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.84|97.84|
91534154|NCT01124162|182945995|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.25|||||TWO_SIDED|90.0|97.87|102.69|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.69|97.87|
91534155|NCT02534896|182946027|SUPERIORITY|||||||0.018|||||||Hochberg and Gatekeeping|||||||0.018
91534156|NCT02534896|182946027|SUPERIORITY|||||||0.007|||||||Hochberg and Gatekeeping|||||||0.007
91534157|NCT02534896|182946028|SUPERIORITY|||||||0.028|||||||Hochberg and Gatekeeping|||||||0.028
91534158|NCT02534896|182946028|SUPERIORITY|||||||0.003|||||||Hochberg and Gatekeeping|||||||0.003
91534159|NCT02534896|182946029|SUPERIORITY|||||||0.96|||||||Hochberg and Gatekeeping|||||||0.960
91757840|NCT04943432|183408829|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||T2-T1||||.34
91757841|NCT04943432|183408829|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||T3-T1||||.02
91757842|NCT04943432|183408831|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||T2-T1||||.14
91757843|NCT04943432|183408831|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||T3-T1||||.29
91757844|NCT04943432|183408833|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||T2-T1||||<.001
91757845|NCT04943432|183408833|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||T3-T1||||.23
91534160|NCT02534896|182946029|SUPERIORITY|||||||0.339|||||||Hochberg and Gatekeeping|||||||0.339
91757846|NCT01727414|183408853|SUPERIORITY|General linear mixed models were used to evaluate the subtype\*dose interaction to determine if the subtypes have unique MPH dose-response curves, with the outcome being Attention Deficit Hyperactivity Disorder total symptom scores (minimum=0, maximum=54, higher=worse)|Slope|0.29|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91757847|NCT03281304|183408854|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|0.5|25.0||||||Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.0|0.5|
91757848|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
91757849|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
91534161|NCT02534896|182946030|SUPERIORITY|||||||0.573|||||||Hochberg and Gatekeeping|||||||0.573
91534162|NCT02534896|182946030|SUPERIORITY|||||||0.374|||||||Hochberg and Gatekeeping|||||||0.374
91534163|NCT05349084|182946053|EQUIVALENCE|A Fisher's exact test was performed to determine the association between coronary artery stenosis and PET myocardial blood flow (MBF) values during stress. The following myocardial segments were analyzed: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). Coronary arteries were categorized as coronary arteries with a diameter stenosis ≥50% or \<50%. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min.||||||0.2522||||||The threshold for statistical significance was p = 0.05.|Fisher Exact|||||||0.2522
91757850|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.9|25.2||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|2.9|
91757851|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
91757852|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
91757853|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
91757854|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|-0.7|28.5||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.5|-0.7|
91757855|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
91757856|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.3|20.4||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.4|-9.3|
91511960|NCT00673049|182895908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.35|TWO_SIDED|95.0|0.909|1.31||One-sided significance level at alpha=0.024 was used. Two-sided p-value was reported.|Log Rank|Nominal p-values were reported without adjustment for the interim analysis.||P-value was calculated using log-rank test stratified by gender (Male or Female), Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.310|0.909|0.35
91511961|NCT00673049|182895909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.426|TWO_SIDED|95.0|0.898|1.287||One-sided significance level at alpha=0.001 was used. Two-sided p-value was reported.|Log Rank|||P-value was calculated using log-rank test stratified by gender (Male or Female), ECOG performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.287|0.898|0.426
91511962|NCT00673049|182895910|SUPERIORITY_OR_OTHER||Difference in response rates|1.668||||0.338|TWO_SIDED|95.0|-1.7|5.1|||Chi-squared|||||5.1|-1.7|0.338
91511963|NCT00693992|182895942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0006|TWO_SIDED|95.0|0.47|0.82|||Log Rank|||||0.82|0.47|0.0006
91511964|NCT00693992|182895943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.89|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.89
91511965|NCT00693992|182895945|SUPERIORITY|||||||0.0061|||||||Fisher Exact|||||||0.0061
91511966|NCT00693992|182895946|SUPERIORITY|||||||0.8393|||||||Fisher Exact|||||||0.8393
91511967|NCT04265755|182895949|OTHER|Adjusted analysis utilizes a logistic regression model which includes age, sex, dose switch, Baseline value of interest, and mPRS as covariates and presents the mPRS estimates.|Odds Ratio (OR)|1.01||||0.86|TWO_SIDED|95.0|0.9|1.13|||Regression, Logistic||Based on a 1 standard deviation increase in mPRS.|Odds of achieving at least 50% reduction from Baseline in mean MMD over months 4, 5, and 6 in relation to mPRS.||1.13|0.90|0.86
91511968|NCT01863446|182895955|SUPERIORITY|Unpaired t-test comparing Lighting 1 and Lighting2||||||0.334|||||||t-test, 2 sided|||||||0.334
91511969|NCT01863446|182895955|SUPERIORITY|Unpaired t-test comparing Lighting3 vs Lighting 4||||||0.423|||||||t-test, 2 sided|||||||0.423
91511970|NCT01863446|182895956|SUPERIORITY|Unpaired t-test of Lighting1 vs Lighting2||||||0.78|||||||t-test, 2 sided|||||||0.780
91511971|NCT01863446|182895956|SUPERIORITY|Unpaired t-test of Lighting3 vs Lighting4||||||0.791|||||||t-test, 2 sided|||||||0.791
91511972|NCT01863446|182895957|SUPERIORITY|Unpaired t-test||||||0.883|||||||t-test, 2 sided|||||||0.883
91511973|NCT01863446|182895957|SUPERIORITY|Unpaired t-test||||||0.271|||||||t-test, 2 sided|||||||0.271
91511974|NCT02652780|182895990|SUPERIORITY||Mean Difference (Net)|-0.008||||0.8783|TWO_SIDED|95.0|-0.119|0.102|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.102|-0.119|0.8783
91511975|NCT04177693|182896011|SUPERIORITY|||||||0.112|||||||Kruskal-Wallis|||||||0.112
91511976|NCT04177693|182896012|SUPERIORITY|||||||0.613|||||||Kruskal-Wallis|||||||0.613
91511977|NCT04177693|182896013|SUPERIORITY|||||||0.202|||||||Kruskal-Wallis|||||||0.202
91511978|NCT04177693|182896014|SUPERIORITY|||||||0.508|||||||Kruskal-Wallis|||||||0.508
91511979|NCT04177693|182896015|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
91511980|NCT04177693|182896016|SUPERIORITY|||||||0.327|||||||Kruskal-Wallis|||||||0.327
91511981|NCT04177693|182896017|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||||||0.633
91511982|NCT04177693|182896018|SUPERIORITY|||||||0.146|||||||Kruskal-Wallis|||||||0.146
91534164|NCT05349084|182946054|OTHER|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028||||||The threshold for statistical significance was p = 0.05.|Pearson's correlation test|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028
91534165|NCT01579578|182946060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|12.23||0.688|TWO_SIDED|95.0|-30.81|20.81||two sided p value|ANCOVA|ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.|the difference in LS means is estimated|60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)||20.81|-30.81|0.688
91534166|NCT03688542|182946063|SUPERIORITY||Slope|-1.4|||<|0.05|TWO_SIDED|95.0|-3.8|1.0|||Regression, Linear|Dependant variable = follow-up value; adjusted for baseline value, canton, avg number of residents, mission||||1.0|-3.8|<0.05
91534167|NCT03688542|182946064|SUPERIORITY||Slope|-0.18|||<|0.05|TWO_SIDED|95.0|-0.39|0.03|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.03|-0.39|<0.05
91534168|NCT03688542|182946065|SUPERIORITY||Slope|-0.035|||<|0.05|TWO_SIDED|95.0|-0.095|0.025|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.025|-0.095|<0.05
91534169|NCT03688542|182946066|SUPERIORITY||Slope|-0.237|||<|0.05|TWO_SIDED|95.0|-0.435|-0.04|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||-0.040|-0.435|<0.05
91534170|NCT03688542|182946067|SUPERIORITY||Slope|1.55|||<|0.05|TWO_SIDED|95.0|0.164|2.938|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||2.938|0.164|<0.05
91757857|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|8.6|||||TWO_SIDED|95.0|-7.0|23.6||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.6|-7.0|
91757858|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.8|18.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.3|-12.8|
91757859|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
91511983|NCT04177693|182896019|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
91511984|NCT04177693|182896020|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91511985|NCT04177693|182896021|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91511986|NCT03224468|182896022|SUPERIORITY|Power was determined to be 85.2% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.15|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.40|0.15|<0.001
91511987|NCT03224468|182896023|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.5|TWO_SIDED|95.0|-1.4|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in scale score for MM above and beyond WLC (positive values denote higher score for MM).|The mean difference in scale scores between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's scale scores at baseline.||0.4|-1.4|0.50
91511988|NCT03224468|182896024|SUPERIORITY|Power was determined to be 84.3% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-0.3|0.24||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.24|-0.30|0.90
91511989|NCT03224468|182896025|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.5||0.93|TWO_SIDED|95.0|-0.38|0.39||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.39|-0.38|0.93
91511990|NCT03224468|182896026|SUPERIORITY|Power was determined to be 90.4% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-1.3|-0.43||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||-0.43|-1.30|<0.001
91511991|NCT03224468|182896027|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.0|2.5|||||Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's score at baseline.||2.5|-1.0|
91511992|NCT03224468|182896029|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-19.0|3.5|||||Estimate is the mean difference in the congruency cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||3.5|-19.0|
91511993|NCT03224468|182896030|SUPERIORITY||Mean Difference (Net)|-24.1|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|95.0|-45.9|-2.2|||||Estimate is the mean difference in the switching cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||-2.2|-45.9|
91511994|NCT03224468|182896031|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.007|0.011|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate better ability to identify target items for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.011|-0.007|
91513569|NCT03029208|182898976|SUPERIORITY||LS mean difference|0.16||||0.8997|TWO_SIDED|95.0|-0.09|0.4|||MMRM||MMRM model was fitted from Baseline up to Week 28 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.40|-0.09|0.8997
91513570|NCT03029208|182898976|SUPERIORITY||LS mean difference|0.18||||0.8835|TWO_SIDED|95.0|-0.12|0.47|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.47|-0.12|0.8835
91534171|NCT03688542|182946068|SUPERIORITY||Slope|-12.7|||<|0.05|TWO_SIDED|95.0|-21.5|-4.0|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||-4.0|-21.5|<0.05
91757860|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
91757861|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|-4.3|||||TWO_SIDED|95.0|-20.2|11.9||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||11.9|-20.2|
91757862|NCT03281304|183408856|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.7|19.9||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.9|-11.7|
91757863|NCT03281304|183408857|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-1.5|24.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||24.1|-1.5|
91511995|NCT03224468|182896032|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.8|1.7|||||Estimate is the mean difference in number of total errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.7|-1.8|
91511996|NCT03224468|182896033|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-7.4|0.3|||||Estimate is the mean difference in number of repetition errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.3|-7.4|
91511997|NCT03224468|182896034|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate a greater ability to recognize previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.1|-0.2|
91511998|NCT03224468|182896035|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.2|1.0|||||Estimate is the mean difference in number recalled for MM above and beyond WLC (positive values indicate a greater ability to recall previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.0|-0.2|
91511999|NCT04713748|182896037|OTHER||||||<|0.0001|||||||Interclass correlation coefficient|||||||<0.0001
91512000|NCT00406029|182896041|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.753|TWO_SIDED|95.0|-0.9|1.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.753
91534172|NCT03688542|182946069|SUPERIORITY||Slope|-0.165|||<|0.05|TWO_SIDED|95.0|-0.754|0.424|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||0.424|-0.754|<0.05
91757864|NCT03281304|183408857|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|3.6|35.0||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||35.0|3.6|
91757865|NCT03281304|183408857|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
91512001|NCT00406029|182896041|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.162|TWO_SIDED|95.0|-1.7|0.3||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline at endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.162
91512002|NCT00406029|182896041|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.049|TWO_SIDED|95.0|-2.1|0.0||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-2.1|0.049
91512003|NCT00406029|182896041|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.019|TWO_SIDED|95.0|-2.2|-0.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-2.2|0.019
91512004|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.935|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.9|0.935
91512005|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.326|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.326
91512006|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.07|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.7|0.070
91512007|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.9|0.020
91512008|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.982|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.0|0.982
91512009|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.281|TWO_SIDED|95.0|-1.5|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.5|0.281
91512010|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.261|TWO_SIDED|95.0|-1.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.6|0.261
91512011|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.447|TWO_SIDED|95.0|-1.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.4|0.447
91512012|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.378|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.378
91512013|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.299|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.7|0.299
91757866|NCT03281304|183408857|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.5|18.0||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.0|-12.5|
91757867|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
91512014|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.377|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.6|0.377
91512015|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.707|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-1.3|0.707
91512016|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.562|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.4|0.562
91512017|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.156|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.156
91512018|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.292|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.6|0.292
91512019|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.034|TWO_SIDED|95.0|-2.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.2|0.034
91512020|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.762|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.762
91534173|NCT03688542|182946070|SUPERIORITY||Slope|-4.2|||<|0.05|TWO_SIDED|95.0|-16.0|7.6|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||7.6|-16.0|<0.05
91534174|NCT02341534|182946078|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.21
91534175|NCT01112735|182946138|SUPERIORITY|||||||0.5621|||||||Wilcoxon (Mann-Whitney)|||||||0.5621
91534176|NCT01112735|182946139|SUPERIORITY|||||||0.3595|||||||Wilcoxon (Mann-Whitney)|||||||0.3595
91534177|NCT01112735|182946140|SUPERIORITY|||||||0.9417|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9417
91534178|NCT01112735|182946140|SUPERIORITY|||||||0.5488|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.5488
91534179|NCT01112735|182946140|SUPERIORITY|||||||0.7107|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.7107
91534180|NCT01112735|182946140|SUPERIORITY|||||||0.8809|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.8809
91534181|NCT01112735|182946140|SUPERIORITY|||||||0.4598|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.4598
91534182|NCT01112735|182946140|SUPERIORITY|||||||0.3837|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.3837
91534183|NCT01112735|182946141|SUPERIORITY|||||||0.9699|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9699
91534184|NCT01112735|182946141|SUPERIORITY|||||||0.4709|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.4709
91534185|NCT01112735|182946141|SUPERIORITY|||||||0.1406|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.1406
91534186|NCT01112735|182946141|SUPERIORITY|||||||0.4291|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.4291
91534187|NCT01112735|182946141|SUPERIORITY|||||||0.2704|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.2704
91534188|NCT01112735|182946141|SUPERIORITY|||||||0.7564|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.7564
91757868|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
91534189|NCT02775435|182946159|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.45|0.7||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.70|0.45|<0.0001
91534190|NCT02775435|182946160|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0008|TWO_SIDED|95.0|0.49|0.85||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.85|0.49|0.0008
91534191|NCT00320489|182946165|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||Log Rank|||||||0.612
91534192|NCT00320489|182946166|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||P-Value is for change from baseline at Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.649
91534193|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for change at Week 104 in Mental Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.744
91534194|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for change at Week 104 in Physical Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.653
91534195|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||P-value for change at Week 104 in Physical Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.640
91534196|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.454||95.0||||P-value for change at Week 104 in Role-Physical.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.454
91534197|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for change at Week 104 in Bodily Pain.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.135
91534198|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||P-value for change at Week 104 in General Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.229
91534199|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value for change at Week 104 in Vitality.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.594
91534200|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||P-value for change at Week 104 in Social Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.256
91534201|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||P-value for change at Week 104 in Role-Emotional.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.775
91534202|NCT00320489|182946167|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||P-value for change at Week 104 in Mental Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.781
91534203|NCT00320489|182946168|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.465
91534204|NCT00320489|182946169|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.581
91534205|NCT00320489|182946172|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|P-value is type III p-value of ANOVA model: Total number of hospitalization days = Therapy.||||||0.020
91534206|NCT00320489|182946173|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-value is for Total Score (Items 1-5) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.583
91534207|NCT00320489|182946173|SUPERIORITY_OR_OTHER|||||||0.747||95.0||||P-value is for Total Score (Items 1-4) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.747
91534208|NCT00320489|182946174|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.371
91534209|NCT00320489|182946175|SUPERIORITY_OR_OTHER|||||||0.681||95.0||||P-value is fro change from baseline to Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.681
91534210|NCT00320489|182946176|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for overall satisfaction with current medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.60
91534211|NCT00320489|182946176|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for preference current/previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit||||||.258
91757869|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.4|25.6||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.6|2.4|
91757870|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
91757871|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
91757872|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
91757873|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|0.7|29.9||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||29.9|0.7|
91757874|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.5|20.6||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.6|-9.5|
91757875|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
91757876|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.7|25.1||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.1|-5.7|
91757877|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.4|19.7||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.7|-11.4|
91757878|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
91512021|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.092|TWO_SIDED|95.0|-1.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.9|0.092
91512022|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.013|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.3|0.013
91512023|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005|TWO_SIDED|95.0|-2.5|-0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.4|-2.5|0.005
91512024|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.293|TWO_SIDED|95.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.293
91512025|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.095|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.0|0.095
91512026|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.04||95.0|-2.3|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.3|0.040
91512027|NCT00406029|182896042|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.011|TWO_SIDED|95.0|-2.5|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.5|0.011
91512028|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.47|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.470
91512029|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.505|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.505
91512030|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.114|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.114
91512031|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.042|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.042
91512032|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.684|TWO_SIDED|94.0|-0.8|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.8|0.684
91534212|NCT00320489|182946176|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-value is for side effects - current vs previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.492
91534213|NCT00320489|182946177|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.854
91757879|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
91757880|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|-2.9|||||TWO_SIDED|95.0|-18.8|13.3||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.3|-18.8|
91757881|NCT03281304|183408858|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
91757882|NCT03281304|183408859|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|-0.4|30.8||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||30.8|-0.4|
91757883|NCT03281304|183408859|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
91757884|NCT03281304|183408859|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.0|16.7||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.7|-14.0|
91757885|NCT03281304|183408860|OTHER||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||||0.1|-0.8|
91757886|NCT03281304|183408862|OTHER||Least Squares (LS) Mean Difference|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Month 1||0.3|-0.1|
91757887|NCT03281304|183408862|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||Month 3||0.2|-0.2|
91757888|NCT03281304|183408862|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Month 6||0.3|-0.2|
91757889|NCT03281304|183408864|OTHER||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.1||||||||0.1|-1.2|
91757890|NCT03281304|183408866|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 1||0.3|-0.3|
91757891|NCT03281304|183408866|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||Month 3||0.2|-0.3|
91757892|NCT03281304|183408866|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 6||0.3|-0.3|
91757893|NCT03281304|183408868|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-0.3|23.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.1|-0.3|
91757894|NCT03281304|183408868|OTHER||Adjusted (weighted) difference|18.6|||||TWO_SIDED|95.0|3.5|32.6||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||32.6|3.5|
91757895|NCT03281304|183408868|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.3|28.1||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.1|-3.3|
91757896|NCT03281304|183408868|OTHER||Adjusted (weighted) difference|0.0|||||TWO_SIDED|95.0|-16.1|16.1||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.1|-16.1|
91757897|NCT03281304|183408869|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|1.3|22.0||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.0|1.3|
91757898|NCT03281304|183408869|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-4.2|26.4||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||26.4|-4.2|
91757899|NCT03281304|183408869|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.8|25.2||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|-5.8|
91534214|NCT00320489|182946178|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||||||0.600
91534215|NCT00320489|182946179|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.282
91534216|NCT00320489|182946180|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for PANSS Total Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.834
91534217|NCT00320489|182946180|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value is for PANSS Positive Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.871
91757900|NCT03281304|183408869|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
91757901|NCT00241904|183408892|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||Intention to treat analysis was used||||<0.001
91757902|NCT00241904|183408893|SUPERIORITY|||||||0.003|||||||General Linear Mixed Model|||||||0.003
91757903|NCT00241904|183408894|SUPERIORITY|||||||0.034|||||||General Linear Mixed Model|||||||0.034
91757904|NCT00241904|183408895|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||||||<0.001
91757905|NCT01990612|183408904|SUPERIORITY||Risk Ratio (RR)|0.8||||0.049|TWO_SIDED|95.0|0.64|1.0|||Chi-squared|Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value \<0.46 considered stat sig|One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.|||1.00|0.64|0.049
91757906|NCT01990612|183408905|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.12|3.33|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.33|0.12|
91757907|NCT01990612|183408906|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.55|0.93||||||||0.93|0.55|
91534218|NCT00320489|182946180|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||P-value is for PANSS Negative Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.692
91534219|NCT00320489|182946180|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for PANSS General Psychopathology Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.893
91534220|NCT00320489|182946181|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||Log Rank|||||||0.585
91534221|NCT00320489|182946182|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||Fisher Exact|||||||0.659
91534222|NCT00320489|182946183|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.952
91534223|NCT00320489|182946185|SUPERIORITY_OR_OTHER|||||||0.777||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = baseline, treatment, and investigator.||||||0.777
91534224|NCT00320489|182946186|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Fisher Exact|||||||0.530
91534225|NCT00320489|182946187|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value for fasting glucose.|Fisher Exact|||||||0.258
91534226|NCT00320489|182946187|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for fasting total cholesterol.|Fisher Exact|||||||0.688
91534227|NCT00320489|182946187|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||P-value is for fasting triglycerides.|Fisher Exact|||||||0.908
91512033|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.489|TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.7|0.489
91512034|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.305|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.305
91512035|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.451|TWO_SIDED|95.0|-0.6|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.6|0.451
91534228|NCT00320489|182946188|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||Fisher Exact|||||||0.835
91534229|NCT00320489|182946189|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for ALT.|Fisher Exact|||||||0.834
91534230|NCT00320489|182946189|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value is for AST.|Fisher Exact|||||||0.723
91534231|NCT00320489|182946189|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||P-value is for total bilirubin.|Fisher Exact|||||||0.247
91534232|NCT00320489|182946190|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Fisher Exact|||||||0.885
91534233|NCT01872611|182946197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.2||0.671|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||1.3|0.7|0.671
91534234|NCT01872611|182946198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|0.2|0.7|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.7|0.2|0.001
91534235|NCT02783950|182946253|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
91534236|NCT02783950|182946254|SUPERIORITY|||||||0.7|||||||Wilcoxon Rank Test p-value|||||||0.70
91534237|NCT04358549|182946271|SUPERIORITY||Median Difference (Final Values)|14.0||||0.0415|TWO_SIDED|90.0|||||Log Rank|||||||0.0415
91534238|NCT04358549|182946272|SUPERIORITY||Odds Ratio (OR)|0.653|||||TWO_SIDED|90.0|0.19|2.24||||||||2.240|0.190|
91534239|NCT04358549|182946273|SUPERIORITY||Median Difference (Final Values)|3.0||||0.9879|TWO_SIDED|90.0|||||Log Rank|||||||0.9879
91534240|NCT02004613|182946338|SUPERIORITY||Risk Ratio (RR)|0.91||||0.34|TWO_SIDED|97.8|0.72|1.15|||Regression, Logistic|||Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.||1.15|0.72|0.34
91534241|NCT02004613|182946339|SUPERIORITY||Risk Ratio (RR)|1.48||||0.026|TWO_SIDED|97.8|0.99|2.23|||Regression, Logistic|||hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.||2.23|0.99|0.026
91534242|NCT02004613|182946340|SUPERIORITY||Risk Ratio (RR)|1.4||||0.14|TWO_SIDED|97.5|0.84|2.34|||Regression, Logistic|||||2.34|0.84|0.14
91534243|NCT02004613|182946341|OTHER||Risk Ratio (RR)|0.87||||0.29|TWO_SIDED|97.5|0.65|1.16|||Regression, Logistic|||||1.16|0.65|0.29
91534244|NCT00672256|182946346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
91534245|NCT00672256|182946347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
91534246|NCT00672256|182946348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
91534247|NCT00672256|182946349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
91534248|NCT03710564|182946389|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4537|TWO_SIDED|95.0|-2.1|0.9|||Pairwise ANOVA|||||0.9|-2.1|0.4537
91534249|NCT00293462|182946406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Fisher Exact|Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.||Fisher's exact two tailed test||||0.09
91757908|NCT01990612|183408907|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.32|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.32|
91757909|NCT01990612|183408908|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.35|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.35|
91512036|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.68|TWO_SIDED|95.0|-1.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.5|0.680
91512037|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.466|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.466
91512038|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.45|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.8|0.450
91512039|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.523|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.523
91512040|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.309|TWO_SIDED|95.0|-0.6|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.6|0.309
91512041|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.136|TWO_SIDED|95.0|-0.3|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.3|0.136
91512042|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.106|TWO_SIDED|95.0|-0.2|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.2|0.106
91512043|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.144|TWO_SIDED|95.0|-0.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.3|0.144
91512044|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.954|TWO_SIDED|95.0|-1.1|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.1|0.954
91512045|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.152|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.152
91512046|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.012|TWO_SIDED|95.0|0.3|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.3|0.012
91512047|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
91512048|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.151|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.3|0.151
91512049|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.235|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.235
91512050|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.007|TWO_SIDED|95.0|0.5|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|0.5|0.007
91512051|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.033|TWO_SIDED|95.0|0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.1|0.033
91512052|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.757
91512053|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.341|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.341
91512054|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.024|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.024
91512055|NCT00406029|182896043|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.049|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.049
91512056|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.151|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.151
91512057|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.93|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.1|0.930
91512058|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.343|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.343
91512059|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.746|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.746
91512060|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.222|TWO_SIDED|94.0|-0.5|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.5|0.222
91534250|NCT00293462|182946407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED|95.0|||||Mantel Haenszel|Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis||Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used||||0.92
91757910|NCT01990612|183408909|SUPERIORITY||Risk Ratio (RR)|2.74|||||TWO_SIDED|95.0|0.91|8.12|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||8.12|0.91|
91757911|NCT01990612|183408910|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.31|1.76|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.76|0.31|
91757912|NCT01990612|183408911|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.35|1.19|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.19|0.35|
91757913|NCT01990612|183408912|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.38|1.55|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.55|0.38|
91757914|NCT01990612|183408913|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.48|3.42|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.42|0.48|
91757915|NCT01990612|183408914|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.06|1.79|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.79|0.06|
91757916|NCT01990612|183408915|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.93|0.76|<0.001
91757917|NCT01990612|183408916|SUPERIORITY||Risk Ratio (RR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.92|0.36|0.02
91757918|NCT01990612|183408917|SUPERIORITY||Risk Ratio (RR)|0.85||||0.07|TWO_SIDED|95.0|0.72|1.01|||Chi-squared|||||1.01|0.72|0.07
91757919|NCT01990612|183408918|SUPERIORITY||Risk Ratio (RR)|0.94||||0.35|TWO_SIDED|95.0|0.83|1.07|||Chi-squared|||||1.07|0.83|0.35
91757920|NCT01990612|183408919|SUPERIORITY||Risk Ratio (RR)|1.15||||0.33|TWO_SIDED|95.0|0.87|1.52|||Chi-squared|||||1.52|0.87|0.33
91757921|NCT01990612|183408921|SUPERIORITY||Risk Ratio (RR)|0.5||||0.26|TWO_SIDED|95.0|0.13|1.55|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||1.55|0.13|0.26
91757922|NCT01990612|183408922|SUPERIORITY||Risk Ratio (RR)|0.64|||<|0.001|TWO_SIDED|95.0|0.56|0.74||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.74|0.56|<0.001
91757923|NCT01990612|183408923|SUPERIORITY||Risk Ratio (RR)|1.03||||0.81|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||||1.29|0.82|0.81
91757924|NCT01990612|183408924|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 6-96 hours after delivery||||<0.001
91757925|NCT01990612|183408924|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 4-8 weeks after delivery||||0.01
91757926|NCT01990612|183408925|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Worst labor pain score||||<0.001
91757927|NCT01990612|183408925|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Overall labor pain score||||<0.001
91757928|NCT01990612|183408926|SUPERIORITY||Risk Ratio (RR)|0.76||||0.15|TWO_SIDED|95.0|0.53|1.1|||Chi-squared|||||1.10|0.53|0.15
91757929|NCT01990612|183408927|SUPERIORITY||Risk Ratio (RR)|1.99||||1|TWO_SIDED|95.0|0.26|26.8|||Chi-squared|The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.|Exact confidence intervals are provided for rare outcomes.|||26.8|0.26|1.00
91757930|NCT01990612|183408929|SUPERIORITY|||||||0.01|||||||Cochran-Armitage trend test|||||||0.01
91757931|NCT01990612|183408930|SUPERIORITY||Risk Ratio (RR)|0.92||||0.56|TWO_SIDED|95.0|0.68|1.23|||Chi-squared|||||1.23|0.68|0.56
91757932|NCT01990612|183408931|SUPERIORITY||Risk Ratio (RR)|0.9||||0.56|TWO_SIDED|95.0|0.64|1.28|||Chi-squared|||||1.28|0.64|0.56
91757933|NCT01990612|183408932|SUPERIORITY||Risk Ratio (RR)|0.79||||0.75|TWO_SIDED|95.0|0.2|2.74|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||2.74|0.20|0.75
91757934|NCT01990612|183408933|SUPERIORITY||Risk Ratio (RR)|1.01||||0.91|TWO_SIDED|95.0|0.81|1.27|||Chi-squared|||||1.27|0.81|0.91
91757935|NCT01990612|183408934|SUPERIORITY||Risk Ratio (RR)|1.05||||0.84|TWO_SIDED|95.0|0.66|1.66|||Chi-squared|||||1.66|0.66|0.84
91757936|NCT01990612|183408935|SUPERIORITY||Risk Ratio (RR)|0.9||||0.13|TWO_SIDED|95.0|0.79|1.03|||Chi-squared|||||1.03|0.79|0.13
91757937|NCT01990612|183408936|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank-Sum|||||||<0.001
91757938|NCT01990612|183408937|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.01
91757939|NCT01990612|183408938|SUPERIORITY|||||||0.002||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.002
91757940|NCT01990612|183408940|OTHER||Odds Ratio, log|1.01||||0.88|TWO_SIDED|95.0|0.89|1.15||Odds ratios from multinomial logistic regression.|Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.||1.15|0.89|0.88
91534251|NCT00293462|182946408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0||||0.28 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||Multilevel regression was used.||||0.28
91534252|NCT00293462|182946409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||0.78 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.78
91534253|NCT00293462|182946410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||0.22 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.22
91534254|NCT00372060|182946411|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0|-1.0|-0.6|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline HbA1c.||||-0.6|-1.0|<0.001
91534255|NCT00372060|182946412|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001||95.0|-23.4|-10.0|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline fasting plasma glucose.||||-10.0|-23.4|<0.001
91534256|NCT00372060|182946413|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-49.2|STANDARD_ERROR_OF_MEAN|7.7|<|0.001||95.0|-64.5|-33.9|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline 2-hour postprandial glucose.||||-33.9|-64.5|<0.001
91534257|NCT00647348|182946415|OTHER|intention-to-treat analysis||||||0.003|||||||BBSI=brain boundary shift integral|||||||0.003
91534258|NCT00647348|182946416|SUPERIORITY|||||||0.05||||||EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|ANCOVA|EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.||||||0.05
91534259|NCT01119703|182946445|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.1|||||TWO_SIDED|95.0|-13.8|-0.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||-0.7|-13.8|
91534260|NCT01119703|182946446|SUPERIORITY_OR_OTHER||Coefficient of Determination %|17.6|||||TWO_SIDED|95.0|10.6|20.9|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||20.9|10.6|
91534261|NCT01119703|182946447|SUPERIORITY_OR_OTHER||Coefficient of Determination %|27.8|||||TWO_SIDED|95.0|19.6|32.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||32.4|19.6|
91534262|NCT01119703|182946448|SUPERIORITY_OR_OTHER||Coefficient of Determination %|3.3||||||95.0|-2.8|8.5|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||8.5|-2.8|
91534263|NCT01119703|182946449|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.04||||0.66|TWO_SIDED|95.0|-0.2|0.13|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Hepatitis B||0.13|-0.2|0.66
91534264|NCT01119703|182946449|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.1||||0.26|TWO_SIDED|95.0|-0.07|0.25|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Cholera||0.25|-0.07|0.26
91534265|NCT01119703|182946449|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.53|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Tetanus||0.53|0.26|<0.001
91534266|NCT01119703|182946449|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.17||||0.04|TWO_SIDED|95.0|-0.32|-0.01|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Cholera||-0.01|-0.32|0.04
91534267|NCT01119703|182946449|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.09||||0.3|TWO_SIDED|95.0|-0.25|0.08|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Tetanus||0.08|-0.25|0.30
91534268|NCT01119703|182946449|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.08||||0.36|TWO_SIDED|95.0|-0.09|0.24|||Fisher's Z-transformation||Within-participant rank correlation|Cholera versus Tetanus||0.24|-0.09|0.36
91534269|NCT01119703|182946450|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.5|||||TWO_SIDED|95.0|-16.6|-2.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||-2.7|-16.6|
91534270|NCT01119703|182946451|SUPERIORITY_OR_OTHER||Coefficient of Determination %|23.7|||||TWO_SIDED|95.0|14.0|29.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||29.7|14.0|
91534271|NCT01119703|182946452|SUPERIORITY_OR_OTHER||Coefficient of Determination %|36.7|||||TWO_SIDED|95.0|28.7|41.5|||||Crossvalidated;negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||41.5|28.7|
91534272|NCT01119703|182946453|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-2.2|||||TWO_SIDED|95.0|-7.8|4.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||4.4|-7.8|
91534273|NCT04668144|182946468|NON_INFERIORITY|Under the assumption of 0 difference in mean PRU between groups and a common standard deviation of 50 PRU, a sample size of 22 patients per group would allow for the 95%CI to stay within ± 45 PRU with a 90% power and alpha=0.05. In line with previously reported investigations, 45 PRU was chosen for the noninferiority margin for the upper 95%CI limit of the difference.|Mean Difference (Final Values)|130.0|||||TWO_SIDED|95.0|85.0|176.0||p-value was not calculated for noninferiority analysis|ANCOVA|||The primary hypothesis of our study was that in patients receiving concomitant administration of cangrelor and prasugrel (experimental arm), platelet inhibition as assessed by PRU would be noninferior to patients receiving prasugrel only (active control)||176|85|
91534274|NCT03441984|182946471|OTHER||Ratio of geometric LS means|1.6946|||||TWO_SIDED|90.0|1.569|1.8373|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented|||1.8373|1.5690|
91534275|NCT03441984|182946471|OTHER||Ratio of geometric LS means|1.3512|||||TWO_SIDED|90.0|1.2465|1.4647|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4647|1.2465|
91534276|NCT03441984|182946471|OTHER||Ratio of geometric LS means|1.2541|||||TWO_SIDED|90.0|1.1569|1.3595|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented|||1.3595|1.1569|
91534277|NCT03441984|182946472|OTHER||Ratio of geometric LS means|1.7001|||||TWO_SIDED|90.0|1.5685|1.8428|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8428|1.5685|
91534278|NCT03441984|182946472|OTHER||Ratio of geometric LS means|1.3519|||||TWO_SIDED|90.0|1.2475|1.465|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4650|1.2475|
91757941|NCT01990612|183408940|OTHER||Odds Ratio, log|0.98||||0.78|TWO_SIDED|95.0|0.86|1.12|||Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.||1.12|0.86|0.78
91757942|NCT02980133|183408962|SUPERIORITY||LS mean difference|1.9||||0.285|TWO_SIDED|95.0|-1.6|5.3||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||5.3|-1.6|0.285
91534279|NCT03441984|182946472|OTHER||Ratio of geometric LS means|1.2576|||||TWO_SIDED|90.0|1.1605|1.3629|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3629|1.1605|
91534280|NCT03441984|182946473|OTHER||Ratio of geometric LS means|1.7382|||||TWO_SIDED|90.0|1.5983|1.8904|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8904|1.5983|
91534281|NCT03441984|182946473|OTHER||Ratio of geometric LS means|1.3614|||||TWO_SIDED|90.0|1.2525|1.4798|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4798|1.2525|
91534282|NCT03441984|182946473|OTHER||Ratio of geometric LS means|1.2768|||||TWO_SIDED|90.0|1.1746|1.3878|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3878|1.1746|
91757943|NCT02980133|183408963|SUPERIORITY||Least square (LS) mean difference|6.0|||<|0.001|TWO_SIDED|95.0|3.2|8.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (inhaled corticosteroid \[ICS\] or noncorticosteroid \[NCS\]), and investigational medicinal product (IMP) treatment group.||8.8|3.2|<0.001
91512061|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.673|TWO_SIDED|95.0|-1.0|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.0|0.673
91512062|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.415|TWO_SIDED|95.0|-0.7|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.7|0.415
91534283|NCT03441984|182946474|OTHER||Ratio of geometric LS means|1.0407|||||TWO_SIDED|90.0|1.0118|1.0704|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0704|1.0118|
91534284|NCT03441984|182946474|OTHER||Ratio of geometric LS means|1.0228|||||TWO_SIDED|90.0|0.9944|1.052|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0520|0.9944|
91534285|NCT03441984|182946474|OTHER||Ratio of geometric LS means|1.0175|||||TWO_SIDED|90.0|0.9893|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9893|
91534286|NCT03441984|182946475|OTHER||Ratio of geometric LS means|1.041|||||TWO_SIDED|90.0|1.0121|1.0708|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0708|1.0121|
91534287|NCT03441984|182946475|OTHER||Ratio of geometric LS means|1.0232|||||TWO_SIDED|90.0|0.9948|1.0524|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0524|0.9948|
91534288|NCT03441984|182946475|OTHER||Ratio of geometric LS means|1.0174|||||TWO_SIDED|90.0|0.9892|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9892|
91534289|NCT03441984|182946476|OTHER||Ratio of geometric LS means|1.0533|||||TWO_SIDED|90.0|0.9885|1.1223|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.1223|0.9885|
91534290|NCT03441984|182946476|OTHER||Ratio of geometric LS means|0.9766|||||TWO_SIDED|90.0|0.9167|1.0405|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0405|0.9167|
91534291|NCT03441984|182946476|OTHER||Ratio of geometric LS means|1.0785|||||TWO_SIDED|90.0|1.0123|1.149|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1490|1.0123|
91534292|NCT03441984|182946477|OTHER||Ratio of geometric LS means|1.0|||||TWO_SIDED|90.0|0.9536|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9536|
91757944|NCT02980133|183408963|SUPERIORITY||LS mean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.1|9.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||9.8|4.1|<0.001
91534293|NCT03441984|182946477|OTHER||Ratio of geometric LS means|0.9478|||||TWO_SIDED|90.0|0.9039|0.9939|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9939|0.9039|
91534294|NCT03441984|182946477|OTHER||Ratio of geometric LS means|1.055|||||TWO_SIDED|90.0|1.0061|1.1063|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1063|1.0061|
91534295|NCT03441984|182946478|OTHER||Ratio of geometric LS means|0.9994|||||TWO_SIDED|90.0|0.9525|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9525|
91534296|NCT03441984|182946478|OTHER||Ratio of geometric LS means|0.9432|||||TWO_SIDED|90.0|0.899|0.9896|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9896|0.8990|
91534297|NCT03441984|182946478|OTHER||Ratio of geometric LS means|1.0596|||||TWO_SIDED|90.0|1.0099|1.1117|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1117|1.0099|
91534298|NCT03441984|182946479|OTHER||Ratio of geometric LS means|0.9362|||||TWO_SIDED|90.0|0.8677|1.0101|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0101|0.8677|
91534299|NCT03441984|182946479|OTHER||Ratio of geometric LS means|0.9079|||||TWO_SIDED|90.0|0.8416|0.9795|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9795|0.8416|
91757945|NCT01854281|183408972|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||0.02
91757946|NCT01854281|183408972|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||<0.01
91757947|NCT03208088|183408973|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|95.0|0.1|11.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 1 - Control.|||11.6|0.1|
91757948|NCT03208088|183408973|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-4.0|8.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 2 - Control.|||8.1|-4.0|
91757949|NCT03208088|183408974|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-7.5|4.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 3 - Control.|||4.6|-7.5|
91757950|NCT03208088|183408974|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean|-3.4|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-9.0|2.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 4 - Control.|||2.3|-9.0|
91534300|NCT03441984|182946479|OTHER||Ratio of geometric LS means|1.0312|||||TWO_SIDED|90.0|0.9558|1.1124|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1124|0.9558|
91534301|NCT03441984|182946480|OTHER||Ratio of geometric LS means|1.6439|||||TWO_SIDED|90.0|1.4649|1.8449|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8449|1.4649|
91534302|NCT03441984|182946480|OTHER||Ratio of geometric LS means|1.2698|||||TWO_SIDED|90.0|1.1315|1.425|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4250|1.1315|
91534303|NCT03441984|182946480|OTHER||Ratio of geometric LS means|1.2946|||||TWO_SIDED|90.0|1.1536|1.4529|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4529|1.1536|
91534304|NCT03441984|182946481|OTHER||Ratio of geometric LS means|1.6578|||||TWO_SIDED|90.0|1.4709|1.8685|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8685|1.4709|
91534305|NCT03441984|182946481|OTHER||Ratio of geometric LS means|1.2755|||||TWO_SIDED|90.0|1.1317|1.4375|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4375|1.1317|
91534306|NCT03441984|182946481|OTHER||Ratio of geometric LS means|1.2998|||||TWO_SIDED|90.0|1.1533|1.465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4650|1.1533|
91534307|NCT03441984|182946482|OTHER||Ratio of geometric LS means|1.9758|||||TWO_SIDED|90.0|1.7585|2.2201|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||2.2201|1.7585|
91757951|NCT00360724|183408982|SUPERIORITY_OR_OTHER||F statistics|9.43||||0.003|||||||Repeated Measures ANOVA|df 1,55|time X Drug group, f=9.43,df 1,55, p=.003|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||.003
91534308|NCT03441984|182946482|OTHER||Ratio of geometric LS means|1.2873|||||TWO_SIDED|90.0|1.1457|1.4465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4465|1.1457|
91534309|NCT03441984|182946482|OTHER||Ratio of geometric LS means|1.5348|||||TWO_SIDED|90.0|1.366|1.7245|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.7245|1.3660|
91534310|NCT03441984|182946483|OTHER||Ratio of geometric LS means|0.9798|||||TWO_SIDED|90.0|0.9241|1.0389|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0389|0.9241|
91534311|NCT03441984|182946483|OTHER||Ratio of geometric LS means|0.9605|||||TWO_SIDED|90.0|0.9059|1.0185|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0185|0.9059|
91757952|NCT00360724|183408984|SUPERIORITY_OR_OTHER||F statistics|8.72||||0.05|||||||Repeated Measures ANOVA|d.f. 1,55|Time x Treatment: F=8.72, d.f=1,55, p=0.05|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.05
91757953|NCT00360724|183408985|SUPERIORITY_OR_OTHER||F statistics|5.33||||0.025|||||||Repeated measures ANOVA|d.f. 1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.025
91757954|NCT00360724|183408986|SUPERIORITY_OR_OTHER||F statistics|0.26||||0.6|||||||Repeated measures ANOVA|d.f.=1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.6
91757955|NCT00360724|183408991|OTHER||Mean Difference (Final Values)|4.0||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
91534312|NCT03441984|182946483|OTHER||Ratio of geometric LS means|1.0201|||||TWO_SIDED|90.0|0.9633|1.0802|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0802|0.9633|
91534313|NCT03441984|182946484|OTHER||Ratio of geometric LS means|0.9831|||||TWO_SIDED|90.0|0.9243|1.0457|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0457|0.9243|
91534314|NCT03441984|182946484|OTHER||Ratio of geometric LS means|0.9702|||||TWO_SIDED|90.0|0.9121|1.032|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0320|0.9121|
91534315|NCT03441984|182946484|OTHER||Ratio of geometric LS means|1.0134|||||TWO_SIDED|90.0|0.9527|1.0779|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0779|0.9527|
91534316|NCT03441984|182946485|OTHER||Ratio of geometric LS means|0.91|||||TWO_SIDED|90.0|0.8196|1.0102|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0102|0.8196|
91534317|NCT03441984|182946485|OTHER||Ratio of geometric LS means|0.9198|||||TWO_SIDED|90.0|0.8285|1.0212|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0212|0.8285|
91534318|NCT03441984|182946485|OTHER||Ratio of geometric LS means|0.9893|||||TWO_SIDED|90.0|0.8911|1.0983|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0983|0.8911|
91757956|NCT00360724|183408992|OTHER||Mean Difference (Final Values)|0.4||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
91757957|NCT00605345|183408999|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was met if the lower limit of the confidence interval for the response rate of the CERA group was greater than the observed response rate of the darbepoetin group minus 15%. The calculated lower limit of an acceptable difference in response rates thus, was based on the actual percentage of responders in the darbepoetin group and this percentage minus 15% had to be excluded."||||||0.5947|||||||Fisher Exact|||||||0.5947
91757958|NCT02577016|183409005|SUPERIORITY||Difference in least squares means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.05|-0.62|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.62|-1.05|<0.001
91757959|NCT02577016|183409008|SUPERIORITY||Difference in least squares means|-42.5|||<|0.001|TWO_SIDED|95.0|-53.7|-31.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-31.2|-53.7|<0.001
91757960|NCT02577016|183409009|SUPERIORITY||Difference in least squares means|-67.0|||<|0.001|TWO_SIDED|95.0|-84.0|-50.0|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-50.0|-84.0|<0.001
91757961|NCT02577016|183409010|SUPERIORITY||Difference in least squares means|-11.2|||<|0.001|TWO_SIDED|95.0|-17.2|-5.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-5.2|-17.2|<0.001
91757962|NCT05399290|183409011|OTHER|Chi square analysis was conducted to detect any significant between group differences (100 mg vs 20 mg) in perceived acne severity.||||||0.677|||||||Chi-squared|||||||0.677
91757963|NCT05399290|183409011|OTHER|Friedman's test was conducted for the 100 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.002|||||||Friedman's test|||||||0.002
91757964|NCT05399290|183409011|OTHER|Friedman's test was conducted for the 20 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.018|||||||Fried|||||||0.018
91534319|NCT03441984|182946491|OTHER||Ratio of geometric LS means|1.6503|||||TWO_SIDED|90.0|1.5131|1.8|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8000|1.5131|
91757965|NCT00510744|183409024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|24.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)||||<0.05
91757966|NCT00849862|183409046|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.0|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|85.0|
91757967|NCT00849862|183409047|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.0||||||90.0|96.3|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.3|
91757968|NCT00849862|183409048|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.6||||||90.0|96.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|96.2|
91757969|NCT01532869|183409054|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) mean|-2.7||||0.0915|TWO_SIDED|95.0|-5.85|0.45|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.45|-5.85|0.0915
91757970|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.43||||0.9336|TWO_SIDED|95.0|-10.78|9.91|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.91|-10.78|0.9336
91757971|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.12||||0.4609|TWO_SIDED|95.0|-15.21|6.96|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.96|-15.21|0.4609
91757972|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.28||||0.8493|TWO_SIDED|95.0|-14.7|12.13|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.13|-14.70|0.8493
91757973|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|4.89||||0.4717|TWO_SIDED|95.0|-8.59|18.37|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||18.37|-8.59|0.4717
91757974|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.08||||0.9876|TWO_SIDED|95.0|-9.93|9.78|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.78|-9.93|0.9876
91534320|NCT03441984|182946491|OTHER||Ratio of geometric LS means|1.3501|||||TWO_SIDED|90.0|1.2381|1.4722|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4722|1.2381|
91534321|NCT03441984|182946491|OTHER||Ratio of geometric LS means|1.2224|||||TWO_SIDED|90.0|1.121|1.333|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3330|1.1210|
91534322|NCT03441984|182946500|OTHER||Ratio of geometric LS means|1.0251|||||TWO_SIDED|90.0|0.848|1.2392|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2392|0.8480|
91534323|NCT03441984|182946500|OTHER||Ratio of geometric LS means|0.9181|||||TWO_SIDED|90.0|0.7592|1.1103|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1103|0.7592|
91534324|NCT03441984|182946500|OTHER||Ratio of geometric LS means|1.1165|||||TWO_SIDED|90.0|0.9376|1.3295|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented|||1.3295|0.9376|
91534325|NCT03441984|182946508|OTHER||Ratio of geometric LS means|1.0844|||||TWO_SIDED|90.0|0.9904|1.1873|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1873|0.9904|
91534326|NCT03441984|182946508|OTHER||Ratio of geometric LS means|1.1311|||||TWO_SIDED|90.0|1.0334|1.2379|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2379|1.0334|
91534327|NCT03441984|182946508|OTHER||Ratio of geometric LS means|0.9587|||||TWO_SIDED|90.0|0.876|1.0493|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0493|0.8760|
91757975|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-6.8||||0.2407|TWO_SIDED|95.0|-18.3|4.71|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||4.71|-18.30|0.2407
91757976|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|1.54||||0.7742|TWO_SIDED|95.0|-9.18|12.26|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.26|-9.18|0.7742
91757977|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.48||||0.5182|TWO_SIDED|95.0|-18.28|9.31|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.31|-18.28|0.5182
91534328|NCT03441984|182946516|OTHER||Ratio of geometric LS means|1.5619|||||TWO_SIDED|90.0|1.3678|1.7835|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.7835|1.3678|
91534329|NCT03441984|182946516|OTHER||Ratio of geometric LS means|1.253|||||TWO_SIDED|90.0|1.0973|1.4307|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4307|1.0973|
91757978|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-5.8||||0.3106|TWO_SIDED|95.0|-17.2|5.59|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.59|-17.20|0.3106
91534330|NCT03441984|182946516|OTHER||Ratio of geometric LS means|1.2466|||||TWO_SIDED|90.0|1.0917|1.4234|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4234|1.0917|
91534331|NCT03441984|182946525|OTHER||Ratio of geometric LS means|1.0745|||||TWO_SIDED|90.0|0.9997|1.1549|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.1549|0.9997|
91534332|NCT03441984|182946525|OTHER||Ratio of geometric LS means|1.0706|||||TWO_SIDED|90.0|0.9961|1.1507|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.1507|0.9961|
91534333|NCT03441984|182946525|OTHER||Ratio of geometric LS means|1.0036|||||TWO_SIDED|90.0|0.9338|1.0787|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0787|0.9338|
91534334|NCT02696785|182946598|SUPERIORITY||Odds Ratio (OR)|2.73||||0.005|TWO_SIDED|95.0|1.35|5.52|||Regression, Logistic|||Overall Work Impairment Score||5.52|1.35|0.005
91534335|NCT02696785|182946598|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.2|9.03|||Regression, Logistic|||Overall Work Impairment Score.||9.03|2.20|<0.001
91534336|NCT02696785|182946598|SUPERIORITY||Odds Ratio (OR)|5.09|||<|0.001|TWO_SIDED|95.0|2.52|10.28|||Regression, Logistic|||Overall Work Impairment Score.||10.28|2.52|<0.001
91757979|NCT01532869|183409056|SUPERIORITY_OR_OTHER||Difference in LS mean|-7.82||||0.1717|TWO_SIDED|95.0|-19.11|3.48|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||3.48|-19.11|0.1717
91757980|NCT01532869|183409057|SUPERIORITY_OR_OTHER||Difference in LS mean|0.02||||0.8503|TWO_SIDED|95.0|-0.186|0.225|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction||0.225|-0.186|0.8503
91757981|NCT01532869|183409057|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.207||||0.1212|TWO_SIDED|95.0|-0.471|0.056|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.056|-0.471|0.1212
91512063|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.968|TWO_SIDED|95.0|-1.3|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.3|0.968
91512064|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.543|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.0|0.543
91512065|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.967|TWO_SIDED|95.0|-1.4|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.4|0.967
91512066|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.411|TWO_SIDED|95.0|-0.8|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.8|0.411
91512067|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.864|TWO_SIDED|95.0|-1.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.6|0.864
91512068|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.449|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.449
91512069|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.411|TWO_SIDED|95.0|-2.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.0|0.411
91512070|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.576|TWO_SIDED|95.0|-1.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.0|0.576
91512071|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.603|TWO_SIDED|95.0|-1.9|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.9|0.603
91512072|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.842|TWO_SIDED|95.0|-1.4|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.4|0.842
91512073|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.558|TWO_SIDED|95.0|-1.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.9|0.558
91512074|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.245|TWO_SIDED|95.0|-0.6|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|-0.6|0.245
91512075|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.93|TWO_SIDED|95.0|-1.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.5|0.930
91512076|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.759|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.5|0.759
91512077|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.374|TWO_SIDED|95.0|-2.4|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.4|0.374
91512078|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
91512079|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.607|TWO_SIDED|95.0|-2.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-2.1|0.607
91512080|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.907|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.907
91512081|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.368|TWO_SIDED|95.0|-2.1|0.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.1|0.368
91512082|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.654|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.1|0.654
91534337|NCT02696785|182946598|SUPERIORITY||LSMean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-13.2|-0.7|||ANCOVA|||Percentage of Activity Impairment||-0.7|-13.2|<0.001
91534338|NCT02696785|182946598|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-15.5|-3.0|||ANCOVA|||Percentage of Activity Impairment||-3.0|-15.5|<0.001
91534339|NCT02696785|182946598|SUPERIORITY||LSMean Difference|-8.9|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-15.2|-2.5|||ANCOVA|||Percentage of Activity Impairment||-2.5|-15.2|<0.001
91757982|NCT01532869|183409058|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.99||||0.8118|TWO_SIDED|95.0|-9.2|7.23|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 24.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||7.23|-9.20|0.8118
91757983|NCT01532869|183409058|SUPERIORITY_OR_OTHER||Difference in LS mean|-9.02||||0.0768|TWO_SIDED|95.0|-19.04|1.0|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 48.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||1.00|-19.04|0.0768
91757984|NCT01532869|183409059|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.85||||0.4063|TWO_SIDED|95.0|-13.04|5.34|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.34|-13.04|0.4063
91757985|NCT01532869|183409059|SUPERIORITY_OR_OTHER||Difference in LS mean|-8.3||||0.1371|TWO_SIDED|95.0|-19.31|2.71|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.71|-19.31|0.1371
91757986|NCT01532869|183409060|SUPERIORITY_OR_OTHER||Difference in LS mean|1.43||||0.5197|TWO_SIDED|95.0|-2.97|5.82|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.82|-2.97|0.5197
91757987|NCT01532869|183409060|SUPERIORITY_OR_OTHER||Difference in LS mean|2.75||||0.1886|TWO_SIDED|95.0|-1.38|6.88|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.88|-1.38|0.1886
91757988|NCT01532869|183409061|SUPERIORITY_OR_OTHER||Difference in LS mean|0.79||||0.3651|TWO_SIDED|95.0|-0.94|2.51|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.51|-0.94|0.3651
91757989|NCT01532869|183409061|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.11||||0.2841|TWO_SIDED|95.0|-3.16|0.94|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.94|-3.16|0.2841
91757990|NCT01532869|183409062|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.55||||0.0579|TWO_SIDED|95.0|-7.23|0.12|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.12|-7.23|0.0579
91757991|NCT01532869|183409063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|STANDARD_ERROR_OF_MEAN|0.704||0.2159|TWO_SIDED|95.0|0.6|9.5|||Regression, Logistic|||The logistic regression model included the fixed categorical effects of treatment and the stratification factor of joint involvement at the baseline visit. The continuous covariate of baseline mRSS score was also included in the model.||9.50|0.60|0.2159
91757992|NCT04566692|183409129|NON_INFERIORITY|The bi-weekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|1.035|||||TWO_SIDED|90.0|1.003|1.0685||||||Geometric least-squares means (GLSMs), GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participant as a random effect.||1.0685|1.0030|
91534340|NCT02696785|182946599|SUPERIORITY||Odds Ratio (OR)|2.3||||0.007|TWO_SIDED|95.0|1.25|4.23|||Regression, Logistic|||||4.23|1.25|0.007
91534341|NCT02696785|182946599|SUPERIORITY||Odds Ratio (OR)|2.78||||0.001|TWO_SIDED|95.0|1.48|5.24|||Regression, Logistic|||||5.24|1.48|0.001
91534342|NCT02696785|182946599|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|1.79|6.41|||Regression, Logistic|||||6.41|1.79|<0.001
91534343|NCT02696785|182946600|SUPERIORITY||LSMean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|95.0|-1.11|-0.57|||Mixed Models Analysis|||||-0.57|-1.11|<0.001
91534344|NCT02696785|182946600|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-1.25|-0.7|||Mixed Models Analysis|||||-0.70|-1.25|<0.001
91534345|NCT02696785|182946600|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.18|-0.63|||Mixed Models Analysis|||||-0.63|-1.18|<0.001
91534346|NCT02696785|182946601|SUPERIORITY||Odds Ratio (OR)|2.53||||0.012|TWO_SIDED|95.0|1.23|5.21|||Regression, Logistic|||||5.21|1.23|0.012
91534347|NCT02696785|182946601|SUPERIORITY||Odds Ratio (OR)|3.74|||<|0.001|TWO_SIDED|95.0|1.82|7.7|||Regression, Logistic|||||7.70|1.82|<0.001
91534348|NCT02696785|182946601|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.91|7.98|||Regression, Logistic|||||7.98|1.91|<0.001
91534349|NCT02696785|182946602|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.299||0.001|TWO_SIDED|95.0|-1.56|-0.39|||Mixed Models Analysis|||||-0.39|-1.56|0.001
91534350|NCT02696785|182946602|SUPERIORITY||LSMean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.83|-0.62|||Mixed Models Analysis|||||-0.62|-1.83|<0.001
91757993|NCT04566692|183409132|NON_INFERIORITY|The biweekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|0.97|||||TWO_SIDED|90.0|0.9447|0.9957||||||GLSMs, GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participants as a random effect.||0.9957|0.9447|
91757994|NCT00590577|183409141|SUPERIORITY_OR_OTHER||Difference in least-squares means|-9.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-13.71|-5.85||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-5.85|-13.71|<0.001
91757995|NCT00590577|183409141|SUPERIORITY_OR_OTHER||Difference in least-squares means|-8.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-12.62|-4.78||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-4.78|-12.62|<0.001
91757996|NCT00590577|183409141|SUPERIORITY_OR_OTHER||Difference in least-squares means|-5.1|STANDARD_ERROR_OF_MEAN|2.01||0.034||95.0|-9.01|-1.1||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-1.10|-9.01|0.034
91757997|NCT00590577|183409142|SUPERIORITY_OR_OTHER||Difference in least-squares means|6.2|STANDARD_ERROR_OF_MEAN|1.49|<|0.001||95.0|3.26|9.12||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||9.12|3.26|<0.001
91757998|NCT00590577|183409142|SUPERIORITY_OR_OTHER||Difference in least-squares means|4.4|STANDARD_ERROR_OF_MEAN|1.5||0.007||95.0|1.43|7.31||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||7.31|1.43|0.007
91757999|NCT00590577|183409142|SUPERIORITY_OR_OTHER||Difference in least-squares means|1.0|STANDARD_ERROR_OF_MEAN|1.5||0.509||95.0|-1.96|3.95||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||3.95|-1.96|0.509
91758000|NCT00590577|183409143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
91758001|NCT00590577|183409143|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.005
91758002|NCT00590577|183409143|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.140
91534351|NCT02696785|182946602|SUPERIORITY||LSMean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.86|-0.67|||Mixed Models Analysis|||||-0.67|-1.86|<0.001
91534352|NCT02696785|182946603|SUPERIORITY||LSMean Difference|7.62||||0.009|TWO_SIDED|95.0|1.67|34.68|||Regression, Logistic|||||34.68|1.67|0.009
91534353|NCT02696785|182946603|SUPERIORITY||Odds Ratio (OR)|8.03||||0.007|TWO_SIDED|95.0|1.75|36.83|||Regression, Logistic|||||36.83|1.75|0.007
91758003|NCT03927404|183409145|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).|||||<|0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||<0.05
91534354|NCT02696785|182946603|SUPERIORITY||Odds Ratio (OR)|5.13||||0.041|TWO_SIDED|95.0|1.07|24.49|||Regression, Logistic|||||24.49|1.07|0.041
91534355|NCT02696785|182946604|SUPERIORITY||LSMean Difference|-2.78|STANDARD_ERROR_OF_MEAN|0.447|<|0.001|TWO_SIDED|95.0|-3.7|-1.9|||ANCOVA|||||-1.9|-3.7|<0.001
91534356|NCT02696785|182946604|SUPERIORITY||LSMean Difference|-2.62|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
91534357|NCT02696785|182946604|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.452|<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||ANCOVA|||||-1.5|-3.3|<0.001
91534358|NCT02696785|182946605|SUPERIORITY||LSMean Difference|3.2574|STANDARD_ERROR_OF_MEAN|1.0437||0.002|TWO_SIDED|95.0|1.2041|5.3106|||Mixed Models Analysis|||PCS||5.3106|1.2041|0.002
91534359|NCT02696785|182946605|SUPERIORITY||LSMean Difference|4.052|STANDARD_ERROR_OF_MEAN|1.072|<|0.001|TWO_SIDED|95.0|1.9432|6.1608|||Mixed Models Analysis|||PCS||6.1608|1.9432|<0.001
91534360|NCT02696785|182946605|SUPERIORITY||LSMean Difference|4.3254|STANDARD_ERROR_OF_MEAN|1.0641|<|0.001|TWO_SIDED|95.0|2.2321|6.4186|||Mixed Models Analysis|||PCS||6.4186|2.2321|<0.001
91534361|NCT02696785|182946605|SUPERIORITY||LSMean Difference|0.4321|STANDARD_ERROR_OF_MEAN|1.1718||0.713|TWO_SIDED|95.0|-1.8732|2.7373|||Mixed Models Analysis|||MCS||2.7373|-1.8732|0.713
91534362|NCT02696785|182946605|SUPERIORITY||LSMean Difference|0.6273|STANDARD_ERROR_OF_MEAN|1.2028||0.602|TWO_SIDED|95.0|-1.7387|2.9934|||Mixed Models Analysis|||MCS||2.9934|-1.7387|0.602
91534363|NCT02696785|182946605|SUPERIORITY||LSMean Difference|0.4467|STANDARD_ERROR_OF_MEAN|1.1978||0.709|TWO_SIDED|95.0|-1.9097|2.803|||Mixed Models Analysis|||MCS||2.8030|-1.9097|0.709
91534364|NCT02696785|182946606|SUPERIORITY||LSMean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.416||0.012|TWO_SIDED|95.0|-1.87|-0.23|||Mixed Models Analysis|||||-0.23|-1.87|0.012
91758004|NCT03927404|183409147|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).||||||0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||0.05
91534365|NCT02696785|182946606|SUPERIORITY||LSMean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.428||0.01|TWO_SIDED|95.0|-1.95|-0.27|||Mixed Models Analysis|||||-0.27|-1.95|0.010
91534366|NCT02696785|182946606|SUPERIORITY||LSMean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.423|<|0.001|TWO_SIDED|95.0|-2.32|-0.66|||Mixed Models Analysis|||||-0.66|-2.32|<0.001
91534367|NCT02696785|182946607|SUPERIORITY||LSMean Difference|-8.628|STANDARD_ERROR_OF_MEAN|2.6724||0.001|TWO_SIDED|95.0|-13.885|-3.371|||Mixed Models Analysis|||||-3.371|-13.885|0.001
91534368|NCT02696785|182946607|SUPERIORITY||LSMean Difference|-6.635|STANDARD_ERROR_OF_MEAN|2.7438||0.016|TWO_SIDED|95.0|-12.033|-1.238|||Mixed Models Analysis|||||-1.238|-12.033|0.016
91534369|NCT02696785|182946607|SUPERIORITY||LSMean Difference|-7.991|STANDARD_ERROR_OF_MEAN|2.7248||0.004|TWO_SIDED|95.0|-13.351|-2.631|||Mixed Models Analysis|||||-2.631|-13.351|0.004
91534370|NCT02696785|182946608|SUPERIORITY||LSMean Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.1143||0.001|TWO_SIDED|95.0|-0.592|-0.142|||Mixed Models Analysis|||||-0.142|-0.592|0.001
91534371|NCT02696785|182946608|SUPERIORITY||LSMean Difference|-0.422|STANDARD_ERROR_OF_MEAN|0.1184|<|0.001|TWO_SIDED|95.0|-0.655|-0.189|||Mixed Models Analysis|||||-0.189|-0.655|<0.001
91534372|NCT02696785|182946608|SUPERIORITY||LSMean Difference|-0.329|STANDARD_ERROR_OF_MEAN|0.1167||0.005|TWO_SIDED|95.0|-0.558|-0.099|||Mixed Models Analysis|||||-0.099|-0.558|0.005
91534373|NCT02696785|182946609|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.211||0.003|TWO_SIDED|95.0|0.22|1.05|||Mixed Models Analysis|||||1.05|0.22|0.003
91534374|NCT02696785|182946609|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.219||0.051|TWO_SIDED|95.0|0.0|0.86|||Mixed Models Analysis|||||0.86|-0.00|0.051
91534375|NCT02696785|182946609|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.215||0.005|TWO_SIDED|95.0|0.18|1.03|||Mixed Models Analysis|||||1.03|0.18|0.005
91534376|NCT02696785|182946610|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.321||0.039|TWO_SIDED|95.0|-1.3|-0.03|||Mixed Models Analysis|||||-0.03|-1.30|0.039
91534377|NCT02696785|182946610|SUPERIORITY||LSMean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.33||0.057|TWO_SIDED|95.0|-1.28|0.02|||Mixed Models Analysis|||||0.02|-1.28|0.057
91534378|NCT02696785|182946610|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.327||0.042|TWO_SIDED|95.0|-1.31|-0.03|||Mixed Models Analysis|||||-0.03|-1.31|0.042
91534379|NCT02696785|182946611|SUPERIORITY||LSMean Difference|-5.13|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|-6.7|-3.5|||ANCOVA|||||-3.5|-6.7|<0.001
91534380|NCT02696785|182946611|SUPERIORITY||LSMean Difference|-4.89|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-6.5|-3.3|||ANCOVA|||||-3.3|-6.5|<0.001
91534381|NCT02696785|182946611|SUPERIORITY||LSMean Difference|-5.17|STANDARD_ERROR_OF_MEAN|0.816|<|0.001|TWO_SIDED|95.0|-6.8|-3.6|||ANCOVA|||||-3.6|-6.8|<0.001
91534382|NCT02696785|182946612|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.317|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||||0.5|-1.4|0.317
91534383|NCT02696785|182946612|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.683|TWO_SIDED|95.0|-1.1|0.8|||Mixed Models Analysis|||||0.8|-1.1|0.683
91534384|NCT02696785|182946612|SUPERIORITY||LSMean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.5|TWO_SIDED|95.0|-1.3|0.6|||Mixed Models Analysis|||||0.6|-1.3|0.500
91534385|NCT02696785|182946613|SUPERIORITY||LSMean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.154|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||||0.3|-1.9|0.154
91534386|NCT02696785|182946613|SUPERIORITY||LSMean Difference|0.255|STANDARD_ERROR_OF_MEAN|0.56||-0.6|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||||0.5|-1.8|-0.6
91534387|NCT02696785|182946613|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.398|TWO_SIDED|95.0|-1.6|0.7|||Mixed Models Analysis|||||0.7|-1.6|0.398
91534388|NCT02696785|182946614|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.76||0.783|TWO_SIDED|95.0|-1.7|1.3|||Mixed Models Analysis|||||1.3|-1.7|0.783
91534389|NCT02696785|182946614|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.78||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.550
91512083|NCT00406029|182896044|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.769|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.769
91512084|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.055|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.055
91512085|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.071|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.071
91534390|NCT02696785|182946614|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.77||0.091|TWO_SIDED|95.0|-2.8|0.2|||Mixed Models Analysis|||||0.2|-2.8|0.091
91534391|NCT02696785|182946616|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.027|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.027
91534392|NCT02696785|182946616|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.33||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
91534393|NCT02696785|182946616|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.035|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||||-0.0|-1.3|0.035
91534394|NCT02696785|182946617|SUPERIORITY||LSMean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.3|0.0|||Mixed Models Analysis|||||-0.0|-2.3|0.041
91534395|NCT02696785|182946617|SUPERIORITY||LSMean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.59||0.125|TWO_SIDED|95.0|-2.1|0.3|||Mixed Models Analysis|||||0.3|-2.1|0.125
91534396|NCT02696785|182946617|SUPERIORITY||LSMean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.013|TWO_SIDED|95.0|-2.6|-0.3|||Mixed Models Analysis|||||-0.3|-2.6|0.013
91534397|NCT02696785|182946618|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|3.082||0.989|TWO_SIDED|95.0|-6.03|6.12|||Mixed Models Analysis|||||6.12|-6.03|0.989
91534398|NCT02696785|182946618|SUPERIORITY||LSMean Difference|2.5|STANDARD_ERROR_OF_MEAN|3.146||0.429|TWO_SIDED|95.0|-3.71|8.7|||Mixed Models Analysis|||||8.70|-3.71|0.429
91534399|NCT02696785|182946618|SUPERIORITY||LSMean Difference|-5.47|STANDARD_ERROR_OF_MEAN|3.27||0.096|TWO_SIDED|95.0|-11.92|0.98|||Mixed Models Analysis|||||0.98|-11.92|0.096
91534400|NCT02696785|182946622|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.76||0.166|TWO_SIDED|95.0|-2.6|0.4|||Mixed Models Analysis|||||0.4|-2.6|0.166
91534401|NCT02696785|182946622|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.73||0.011|TWO_SIDED|95.0|-3.4|-0.4|||Mixed Models Analysis|||||-0.4|-3.4|0.011
91534402|NCT02696785|182946622|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.77||0.182|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||||0.5|-2.6|0.182
91534403|NCT02696785|182946623|SUPERIORITY||LSMean Difference|-10.07|STANDARD_ERROR_OF_MEAN|1.588|<|0.001|TWO_SIDED|95.0|-13.2|-6.9|||ANCOVA|||||-6.9|-13.2|<0.001
91534404|NCT02696785|182946623|SUPERIORITY||LSMean Difference|-9.51|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-12.6|-6.4|||ANCOVA|||||-6.4|-12.6|<0.001
91534405|NCT02696785|182946623|SUPERIORITY||LSMean Difference|-8.08|STANDARD_ERROR_OF_MEAN|1.603|<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||ANCOVA|||||-4.9|-11.2|<0.001
91534406|NCT01016353|182946627|SUPERIORITY|||||||0.06|||||||Log Rank|||||||0.06
91534407|NCT04863898|182946628|SUPERIORITY||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-7.0|-5.2|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-5.2|-7|
91534408|NCT04863898|182946632|SUPERIORITY||Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||Calculated using a linear mixed effect regression model with random intercepts by individual Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||1.09|0.86|
91534409|NCT04863898|182946633|SUPERIORITY||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-4.7|-3.6|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-3.6|-4.7|
91534410|NCT00614744|182946634|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that it does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.29|||Bayesian log binomial models|Bayesian log binomial models were used to analyze the primary outcome of death or moderate/severe disability.|In log binomial models used Normal (0, sd=0.35) neutral prior in the log RR scale. Estimation used Normal weakly informative priors. Reported posterior medians \& 95% credible intervals for the RR above instead of confidence intervals.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|"We fitted all Bayesian models via Markov chain Monte Carlo methods (MCMC) using JAGS (version 3.4) and OpenBUGS (3.2.3) in R (version 3.2.5). For each analysis we ran 3 MCMC chains with starting values randomly drawn from the estimated parameters from a frequentist log binomial model. A burn-in of 1,000 iterations was used, with sampling from a further 10,000 iterations for each chain. To monitor convergence, trace plots and the Gelman-Rubin convergence diagnostic (Rhat) were used for all parameters.~For all analyses, the trace plots show good mixing of the 3 chains with Rhat \< 1.01 for all parameters, indicating convergence."|1.29|0.59|
91534411|NCT00770211|182946674|SUPERIORITY_OR_OTHER||Difference response rate|0.48|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.4|0.56|||Fisher Exact|||The efficacy of the treatment was confirmed, if H0 was rejected at a given alpha of 5%, that means if the two sided p-value is ≤ 0.05. Power of 90%||0.56|0.40|<0.0001
91758005|NCT01229449|183409148|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91758006|NCT01229449|183409148|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91758007|NCT01229449|183409148|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
91758008|NCT01229449|183409148|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
91758009|NCT01229449|183409148|SUPERIORITY|||||||0.72|||||||ANOVA|||||||0.72
91758010|NCT01229449|183409148|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91758011|NCT01229449|183409148|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
91758012|NCT01229449|183409148|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
91758013|NCT01229449|183409148|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91758014|NCT01229449|183409148|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
91758015|NCT02641067|183409158|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.0|2.04||||||||2.04|1.00|
91758016|NCT02641067|183409159|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.99|1.92||||||||1.92|0.99|
91758017|NCT02641067|183409160|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.15||||||||1.15|0.61|
91534412|NCT00318656|182946679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.02|STANDARD_ERROR_OF_MEAN|2.49||0.064||95.0|-0.32|10.36|||ANCOVA|Analysis of covariance (ANCOVA)|Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||10.36|-0.32|0.064
91534413|NCT00318656|182946680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|1.45||0.923||95.0|-3.37|2.85||P value von elteren (adjusted on sex)|ANCOVA||Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||2.85|-3.37|0.923
91534414|NCT01446003|182946697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||||TWO_SIDED|90.0|-0.52|4.56|||Linear mixed effect models|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||If the upper limit of the 90% confidence interval lies below the bound 5 mmHg, the hypothesis that change from baseline in ambulatory 24-hour mean SBP in participants with mild to moderate hypertension following 10 days of multiple dosing of MK-8457 is similar to placebo will be supported.||4.56|-0.52|
91534415|NCT01446003|182946698|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.57|||||TWO_SIDED|90.0|0.19|2.96|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||||2.96|0.19|
91534416|NCT01446003|182946699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|90.0|2.44|13.35|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after AM dosing||13.35|2.44|
91534417|NCT01446003|182946699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-5.68|3.81|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after PM dosing||3.81|-5.68|
91534418|NCT01446003|182946699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||||TWO_SIDED|90.0|0.81|9.71|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after AM dosing||9.71|0.81|
91534419|NCT01446003|182946699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||||TWO_SIDED|90.0|-4.55|1.17|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after PM dosing||1.17|-4.55|
91534420|NCT00819234|182946768|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|STANDARD_ERROR_OF_MEAN|2.863||0.0135|TWO_SIDED|95.0|-12.93|-1.54|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.||-1.54|-12.93|0.0135
91534421|NCT00819234|182946768|SUPERIORITY_OR_OTHER||LS Mean|-6.55|STANDARD_ERROR_OF_MEAN|2.681||0.0168|TWO_SIDED|95.0|-11.89|-1.21|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||-1.21|-11.89|0.0168
91534422|NCT00819234|182946768|SUPERIORITY_OR_OTHER||LS Mean|-5.52|STANDARD_ERROR_OF_MEAN|2.887||0.0595|TWO_SIDED|95.0|-11.27|0.23|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||0.23|-11.27|0.0595
91534423|NCT03568162|182946802|SUPERIORITY|The analysis was conducted using a mixed model for repeated measures (MMRM) model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit|LS Mean Difference|-20.192|STANDARD_ERROR_OF_MEAN|7.4781|=|0.008|TWO_SIDED|95.0|-34.944|5.439|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||5.439|-34.944|= 0.008
91534424|NCT03568162|182946802|SUPERIORITY|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|-14.439|STANDARD_ERROR_OF_MEAN|7.6622|=|0.061|TWO_SIDED|95.0|-29.552|0.674|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||0.674|-29.552|= 0.061
91534425|NCT03568162|182946802|SUPERIORITY|The analysis was conducted using a mixed MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|3.144|STANDARD_ERROR_OF_MEAN|7.8864|=|0.691|TWO_SIDED|95.0|-12.41|18.698|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|||18.698|-12.410|= 0.691
91534426|NCT03568162|182946802|SUPERIORITY||LS Mean Difference|-17.199|STANDARD_ERROR_OF_MEAN|6.409|=|0.008|TWO_SIDED|95.0|-29.895|-4.503|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.||-4.503|-29.895|= 0.008
91534427|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0|||||Mixed Models Analysis|||||||0.012
91534428|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.52
91534429|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
91534430|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.29
91758018|NCT01300260|183409175|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.41|3.64||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.64|2.41|<0.001
91758019|NCT01300260|183409175|SUPERIORITY_OR_OTHER||Geometric least squares (LS) means ratio|5.4|||<|0.001|TWO_SIDED|95.0|4.09|7.13||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||7.13|4.09|<0.001
91758020|NCT01300260|183409176|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.09|||<|0.001|TWO_SIDED|95.0|2.66|3.59||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.59|2.66|<0.001
91758021|NCT01300260|183409176|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|7.92|||<|0.001|TWO_SIDED|95.0|4.82|13.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||13.0|4.82|<0.001
91758022|NCT01300260|183409177|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|4.15|||<|0.001|TWO_SIDED|95.0|3.45|5.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||5.00|3.45|<0.001
91758023|NCT01300260|183409177|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.78|||<|0.001|TWO_SIDED|95.0|2.99|4.78||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||4.78|2.99|<0.001
91758024|NCT01300260|183409178|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.04||||0.011|TWO_SIDED|95.0|1.26|3.31||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.31|1.26|0.011
91758025|NCT01300260|183409178|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.44|||<|0.001|TWO_SIDED|95.0|1.71|3.47||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.47|1.71|<0.001
91758026|NCT01300260|183409179|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.22||||0.021|TWO_SIDED|95.0|1.04|1.43||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.43|1.04|0.021
91758027|NCT01300260|183409179|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.27|1.53||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.53|1.27|<0.001
91534431|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
91534432|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.093
91534433|NCT00938340|182946824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.12
91534434|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91534435|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.15
91758028|NCT01300260|183409180|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.43||||0.009|TWO_SIDED|95.0|1.14|1.8||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.80|1.14|0.009
91758029|NCT01300260|183409180|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.75|||<|0.001|TWO_SIDED|95.0|1.59|1.94||P-value is 2-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.94|1.59|<0.001
91758030|NCT02533726|183409181|SUPERIORITY||Odds Ratio (OR)|0.27||||0.012|TWO_SIDED|95.0|0.1|0.75|||Fisher Exact|||Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).||.75|.1|.012
91758031|NCT02533726|183409181|OTHER||Odds Ratio (OR)|0.2||||0.015|TWO_SIDED|95.0|0.06|0.74|||Fisher Exact|||Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.||0.74|0.06|0.015
91758032|NCT01147848|183409187|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.037||||0.162|TWO_SIDED|95.0|-0.088|0.015|||ANCOVA||Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|||0.015|-0.088|0.162
91758033|NCT02540265|183409201|OTHER||Effect Size|1.01|||||TWO_SIDED|||||||||||||
91758034|NCT02540265|183409201|OTHER||Effect Size|0.87|||||TWO_SIDED|||||||||||||
91758035|NCT02540265|183409202|SUPERIORITY|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
91758036|NCT02540265|183409202|SUPERIORITY|||||||0.0076|||||||t-test, 2 sided|||||||0.0076
91758037|NCT02540265|183409203|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
91758038|NCT02540265|183409203|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
91758039|NCT00324233|183409223|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||equivalence testing|||||||0.56
91758040|NCT01972789|183409226|NON_INFERIORITY|This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group|Odds Ratio (OR)|0.4||||0.787|TWO_SIDED|95.0|-2.51|3.32|||Mixed Models Analysis|||||3.32|-2.51|0.787
91512086|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.288|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.288
91512087|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.764|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.764
91512088|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.342|TWO_SIDED|94.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.342
91512089|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.611|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.611
91512090|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.424|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.424
91512091|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.991|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.991
91512092|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.185|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.3|0.185
91512093|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.0|0.597
91512094|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.09|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.5|0.090
91512095|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.686|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.686
91512096|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.501|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.0|0.501
91512097|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.764|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.6|0.764
91512098|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.715|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.715
91512099|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.924|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.7|0.924
91512100|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.264|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.2|0.264
91512101|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.976|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.7|0.976
91512102|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.626|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.9|0.626
91512103|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.925|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.925
91512104|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.849|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.0|0.849
91512105|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.755|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.7|0.755
91512106|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.863|TWO_SIDED|95.0|-0.8|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.8|0.863
91512107|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.477|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.5|0.477
91512108|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.432|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.0|0.432
91758041|NCT01972789|183409227|OTHER||Odds Ratio (OR)|-0.31||||0.833|TWO_SIDED|95.0|-3.2|2.58|||Mixed Models Analysis|||||2.58|-3.20|0.833
91758042|NCT01972789|183409228|OTHER||Odds Ratio (OR)|-21.39||||0.054|TWO_SIDED|95.0|-43.17|0.39|||Mixed Models Analysis|||||0.39|-43.17|0.054
91534436|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.35
91534437|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
91534438|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
91534439|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0002
91534440|NCT00938340|182946825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0013
91534441|NCT00938340|182946826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||Main effect of treatment by timepoint|Mixed Models Analysis|||||||0.15
91534442|NCT00938340|182946827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
91534443|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
91534444|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.98
91534445|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
91534446|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
91534447|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
91534448|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
91534449|NCT00938340|182946828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.16
91534450|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91534451|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
91534452|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
91534453|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.14
91534454|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
91534455|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.22
91534456|NCT00938340|182946829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.074
91534457|NCT00938340|182946830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
91534458|NCT00938340|182946831|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91534459|NCT00938340|182946832|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91534460|NCT00938340|182946833|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91534461|NCT00938340|182946834|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91534462|NCT00938340|182946835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Mixed Models Analysis|||||||0.44
91534463|NCT00938340|182946836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
91534464|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
91534465|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.007
91534466|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.99
91534467|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.037
91534468|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0087||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0087
91534469|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.64
91534470|NCT00938340|182946837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.043
91534471|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91534472|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
91534473|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.21
91534474|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0011
91534475|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0004
91758043|NCT01972789|183409229|OTHER||Negative Binomial Regression|1.11||||0.001|TWO_SIDED|95.0|1.04|1.18|||Mixed Model|||||1.18|1.04|0.001
91534476|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.11
91534477|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.53
91534478|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.59
91534479|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.31
91758044|NCT01972789|183409230|OTHER||Odds Ratio (OR)|0.26||||0.338|TWO_SIDED|95.0|-0.28|0.8|||Mixed Models Analysis|||||0.80|-0.28|0.338
91512109|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.909|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.909
91512110|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.812|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.812
91512111|NCT00406029|182896045|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.54|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.540
91512112|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.829|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.7|0.829
91512113|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.042|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.0|0.042
91512114|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.204|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.204
91512115|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.035|TWO_SIDED|95.0|0.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.1|0.035
91512116|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.696|TWO_SIDED|94.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.696
91512117|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.625|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.625
91758045|NCT01972789|183409231|OTHER||Odds Ratio (OR)|1.44||||0.284|TWO_SIDED|95.0|0.74|2.8|||Regression, Logistic|||Month 12||2.80|0.74|0.284
91758046|NCT01972789|183409231|OTHER||Odds Ratio (OR)|1.29||||0.407|TWO_SIDED|95.0|0.71|2.33|||Regression, Logistic|||Month 24||2.33|0.71|0.407
91758047|NCT01972789|183409232|OTHER||Odds Ratio (OR)|0.35||||0.217|TWO_SIDED|95.0|0.12|1.04|||Regression, Logistic|||||1.04|0.12|0.217
91758048|NCT01972789|183409233|OTHER||Odds Ratio (OR)|0.84||||0.615|TWO_SIDED|95.0|0.42|1.66|||Regression, Logistic|||||1.66|0.42|0.615
91758049|NCT01972789|183409234|OTHER||Odds Ratio (OR)|1.08||||0.819|TWO_SIDED|95.0|0.54|2.18|||Regression, Logistic|||||2.18|0.54|0.819
91512118|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.478|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.478
91512119|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.5|0.380
91512120|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.2|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.2|0.925
91512121|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.285|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.285
91512122|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.296|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.296
91512123|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.241|TWO_SIDED|95.0|-0.5|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.5|0.241
91512124|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.571|TWO_SIDED|95.0|-0.9|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.9|0.571
91512125|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.032|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.032
91512126|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.214|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.4|0.214
91512127|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.051|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.051
91512128|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.572|TWO_SIDED|95.0|-0.9|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.9|0.572
91758050|NCT01972789|183409236|OTHER||Odds Ratio (OR)|4.32||||0.565|TWO_SIDED|95.0|0.03|630.5|||Regression, Logistic|||||630.5|0.03|0.565
91758051|NCT01972789|183409237|OTHER||Odds Ratio (OR)|1.39||||0.034|TWO_SIDED|95.0|1.03|1.9|||Regression, Logistic|||||1.90|1.03|0.034
91758052|NCT00418574|183409238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099||||0.301|TWO_SIDED|95.0|0.919|1.315|||Regression, Cox|||||1.315|0.919|0.301
91758053|NCT01707381|183409248|OTHER||Treatment difference|-1.773|||<|0.001|TWO_SIDED|95.0|-2.38|-1.166|||ANCOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-1.166|-2.380|<0.001
91758054|NCT01707381|183409249|OTHER||Bonferroni t-test used for paired compar|0.01|||<|0.05|TWO_SIDED||||||ANOVA||the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group|Statistical analysis of nocturnal (supine) OPP was performed among baseline, the BOL-303259-X treatment and timolol treatment using ANOVA. the criteria for statistical significance was P\<0.05. Post hoc Bonferroni T-tests were then utilized to compare BOL and timolol groups.||||<0.05
91534480|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.98
91758055|NCT01707381|183409250|OTHER||Mean Difference (Final Values)|-1.77||||0.004|TWO_SIDED|95.0|-2.915|-0.625|||ANOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-0.625|-2.915|0.004
91534481|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
91534482|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
91534483|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.12
91758056|NCT03596450|183409252|SUPERIORITY||Treatment effect|1.36||||0.033|TWO_SIDED|95.0|1.03|1.79|||Regression, Logistic|||Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.||1.79|1.03|0.033
91534484|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.007
91534485|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0089
91534486|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.28
91534487|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
91534488|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.48
91534489|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||<0.0001
91534490|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0003
91534491|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.57
91534492|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.99
91534493|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.71
91534494|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
91534495|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.33
91534496|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.65
91534497|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.66
91534498|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
91534499|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0005
91534500|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0085
91534501|NCT00938340|182946838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.92
91534502|NCT05174065|182946841|SUPERIORITY||Adjusted Difference in Proportion|32.6|||<|0.0001|TWO_SIDED|95.0|18.7|46.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of rounded PPPASI total score range (≤ 20/21 to 30/≥ 31) and focal infection status (yes/no) at baseline.|Based on the Cochran-Mantel-Haenszel method adjusting for the stratification factors. The adjusted difference in proportion was the weighted average of the treatment differences across strata.|||46.5|18.7|<0.0001
91534503|NCT05174065|182946842|SUPERIORITY||Difference in Least Squares Mean|-6.13|||<|0.0001|TWO_SIDED|95.0|-8.57|-3.69|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-3.69|-8.57|<0.0001
91534504|NCT05174065|182946843|SUPERIORITY||Difference in Least Squares Mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and baseline value as covariate.|Apremilast - Placebo|||-0.9|-2.2|<0.0001
91534505|NCT05174065|182946844|SUPERIORITY||Difference in Least Squares Mean|-7.8||||0.033|TWO_SIDED|95.0|-14.9|-0.6|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.6|-14.9|0.0330
91534506|NCT05174065|182946845|SUPERIORITY||Difference in Least Squares Mean|-10.8||||0.0076|TWO_SIDED|95.0|-18.6|-2.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-2.9|-18.6|0.0076
91534507|NCT05174065|182946846|SUPERIORITY||Difference in Least Squares Mean|-1.4||||0.0036|TWO_SIDED|95.0|-2.4|-0.5|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.5|-2.4|0.0036
91758057|NCT04016077|183409328|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|118.5|||||TWO_SIDED|90.0|87.96|159.64|||ANOVA|||||159.64|87.96|
91758058|NCT04016077|183409329|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|104.0|||||TWO_SIDED|90.0|74.48|145.23|||ANOVA|||||145.23|74.48|
91758059|NCT03036189|183409340|SUPERIORITY||Slope|-0.15||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
91758060|NCT03036189|183409341|SUPERIORITY||Slope|0.42||||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
91758061|NCT03036189|183409342|SUPERIORITY||Slope|0.12||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
91534508|NCT00924560|182946851|NON_INFERIORITY_OR_EQUIVALENCE|91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.67|0.2|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.20|-0.67|
91534509|NCT00924560|182946851|NON_INFERIORITY_OR_EQUIVALENCE|28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.49|-0.61|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.61|-1.49|
91534510|NCT00924560|182946852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|-0.00|
91534511|NCT00924560|182946852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
91534512|NCT00924560|182946852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
91534513|NCT00924560|182946852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.02|-0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.01|-0.02|
91534514|NCT00924560|182946853|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|||||TWO_SIDED|95.0|-0.08|0.42||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.42|-0.08|
91534515|NCT00924560|182946853|SUPERIORITY_OR_OTHER||LS mean Difference|-0.43|||||TWO_SIDED|95.0|-0.68|-0.18||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.18|-0.68|
91534516|NCT00924560|182946853|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.24|-0.39|
91534517|NCT00924560|182946853|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||||TWO_SIDED|95.0|-1.05|-0.42||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.42|-1.05|
91534518|NCT00924560|182946854|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
91534519|NCT00924560|182946854|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
91534520|NCT00924560|182946854|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
91534521|NCT00924560|182946854|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|0.95|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
91534522|NCT00924560|182946855|SUPERIORITY_OR_OTHER||LS mean Difference|0.13|||||TWO_SIDED|95.0|-0.03|0.28||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.28|-0.03|
91534523|NCT00924560|182946855|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.11|-0.20|
91534524|NCT00924560|182946855|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.34|-0.01|
91534525|NCT00924560|182946855|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.32|0.03||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.03|-0.32|
91534526|NCT00924560|182946856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
91534527|NCT00924560|182946856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
91758062|NCT03036189|183409343|SUPERIORITY||Slope|0.37||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
91758063|NCT03036189|183409344|SUPERIORITY||Slope|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
91534528|NCT00924560|182946856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
91758064|NCT03036189|183409345|SUPERIORITY||Slope|0.49||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
91758065|NCT03036189|183409346|SUPERIORITY||Slope|-0.03||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
91758066|NCT03036189|183409347|SUPERIORITY||Slope|0.45||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
91758067|NCT03036189|183409348|SUPERIORITY||Slope|0.25||||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
91758068|NCT03036189|183409349|SUPERIORITY||Slope|0.54|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
91534529|NCT00924560|182946856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
91534530|NCT00924560|182946857|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.48|||||TWO_SIDED|95.0|-23.57|12.61||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||12.61|-23.57|
91534531|NCT00924560|182946857|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.55|||||TWO_SIDED|95.0|-25.65|10.55||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.55|-25.65|
91534532|NCT00924560|182946857|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.09|||||TWO_SIDED|95.0|-34.99|10.81||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.81|-34.99|
91534533|NCT00924560|182946857|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.17|||||TWO_SIDED|95.0|-44.08|1.74||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||1.74|-44.08|
91534534|NCT02753530|182947022|SUPERIORITY||Least Square (LS) Mean Difference|-0.99||||0.1146|TWO_SIDED|95.0|-2.23|0.24||Primary Estimand (Treatment Policy)|Mixed Models Analysis|||The baseline observation was the last observation recorded prior to the first dose of study medication. The change from baseline in IBMFRS total score was analyzed using a Mixed Models for Repeated Measures (MMRM) with treatment interacting with visit and trial site as factors. Baseline IBMFRS total score interacting with visit was further included as covariate. An unstructured covariance matrix was assumed.||0.24|-2.23|0.1146
91534535|NCT02909101|182947086|SUPERIORITY|||||||0.039|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.039
91534536|NCT02909101|182947087|SUPERIORITY|||||||0.054|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.054
91534537|NCT02909101|182947088|OTHER|||||||0.744|||||||t-test, 2 sided|||To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.744
91534538|NCT02909101|182947089|OTHER|||||||0.719|||||||t-test, 2 sided|||To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.719
91534539|NCT02909101|182947090|SUPERIORITY|||||||0.337|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.337
91534540|NCT02909101|182947091|SUPERIORITY|||||||0.025|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.025
91534541|NCT02909101|182947092|SUPERIORITY|||||||0.133|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.133
91534542|NCT01290094|182947094|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
91534543|NCT01290094|182947095|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
91534544|NCT01290094|182947096|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.001
91534545|NCT01290094|182947097|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.056
91534546|NCT01290094|182947098|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
91534547|NCT01290094|182947098|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
91534548|NCT01290094|182947099|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
91534549|NCT01290094|182947099|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.027
91535622|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.13|STANDARD_ERROR_OF_MEAN|2.42||0.0359|TWO_SIDED|95.0|-9.91|-0.34||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.34|-9.91|0.0359
91758069|NCT03036189|183409350|SUPERIORITY||Slope|1.99||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
91758070|NCT03036189|183409351|SUPERIORITY||Slope|1.05||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
91758071|NCT03036189|183409352|SUPERIORITY||Slope|2.0||||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
91758072|NCT03036189|183409353|SUPERIORITY||Slope|-23.01||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
91758073|NCT03262441|183409354|OTHER||Slope|-0.00033|||||TWO_SIDED|95.0|-0.002|0.0014||||||||0.0014|-0.0020|
91758074|NCT03262441|183409355|OTHER||Slope|0.001|||||TWO_SIDED|95.0|-0.0036|0.0056||||||||0.0056|-0.0036|
91758075|NCT03262441|183409356|OTHER||Slope|0.0024|||||TWO_SIDED|95.0|-0.003|0.0078||||||||0.0078|-0.003|
91758076|NCT01455194|183409375|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.122|STANDARD_ERROR_OF_MEAN|0.1175||0.2988|TWO_SIDED|95.0|-0.353|0.109|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.109|-0.353|0.2988
91534550|NCT00646451|182947111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162|||||||ANOVA|||"Outcome on study completers was assessed via ANOVA models using a 2 × 2 Latin-square crossover design including sequence, period, and treatment effects. A significant carryover effect was excluded. Analyses were performed using Stata IC version 10.0 for Windows.~Unfortunately the small sample size of our study limits the possibility of a meaningful post-hoc analysis targeted to these variables."|The Quest rates patient perception of health status as influenced by tremor across 5 domains, physical, psychosocial, communication, hobbies/leisure, and work/finance. HAM-A rates severity of anxiety symptomatology across 14 parameters. Scores of 14-17 correspond to mild anxiety, scores of 18-24 is moderate anxiety and 25-30 severe anxiety. HD-16 rates insomnia-related QoL across 5 domains: physical symptoms, energy \& motivation, concentration, interpersonal relations and psychological symptoms. These scales were scored per published guidelines.|||0.162
91534551|NCT00157014|182947134|SUPERIORITY_OR_OTHER|||||||0.4725||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.4725
91534552|NCT00157014|182947145|SUPERIORITY_OR_OTHER|||||||0.8373||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.8373
91534553|NCT01362491|182947148|SUPERIORITY_OR_OTHER||Least-Square (LS) mean difference|6.11|||<|0.001|TWO_SIDED|95.0|4.49|7.73||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||7.73|4.49|<0.001
91534554|NCT01362491|182947149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.253|TWO_SIDED|95.0|0.88|1.65||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.65|0.88|0.253
91534555|NCT01362491|182947150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.38|||<|0.001|TWO_SIDED|95.0|2.69|7.14||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.14|2.69|<0.001
91534556|NCT01362491|182947150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.64|||<|0.001|TWO_SIDED|95.0|2.23|5.94||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||5.94|2.23|<0.001
91534557|NCT01362491|182947151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.68|||<|0.001|TWO_SIDED|95.0|2.87|7.64||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.64|2.87|<0.001
91534558|NCT01362491|182947151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.88|||<|0.001|TWO_SIDED|95.0|2.38|6.34||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||6.34|2.38|<0.001
91534559|NCT01362491|182947151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.247|TWO_SIDED|95.0|0.88|1.66||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.66|0.88|0.247
91758077|NCT01455194|183409375|SUPERIORITY_OR_OTHER||LS Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.118||0.7741|TWO_SIDED|95.0|-0.198|0.266|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.266|-0.198|0.7741
91758078|NCT01455194|183409375|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.1172||0.1835|TWO_SIDED|95.0|-0.387|0.074|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.074|-0.387|0.1835
91534560|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.92|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.92|<0.001
91534561|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.93|1.61||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.61|0.93|< 0.001
91758079|NCT01455194|183409377|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|0.0||||0.8465|TWO_SIDED|95.0|-3.0|4.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||4.000|-3.000|0.8465
91758080|NCT01455194|183409377|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|1.0||||0.4175|TWO_SIDED|95.0|-2.0|5.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||5.000|-2.000|0.4175
91758081|NCT01455194|183409378|SUPERIORITY_OR_OTHER|||||||0.4186|||||||Fisher Exact|||Well-controlled Asthma||||0.4186
91758082|NCT01455194|183409378|SUPERIORITY_OR_OTHER|||||||0.146|||||||Fisher Exact|||Well-controlled Asthma||||0.1460
91758083|NCT01455194|183409378|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Fisher Exact|||Well-controlled Asthma||||0.6017
91758084|NCT01455194|183409378|SUPERIORITY_OR_OTHER|||||||0.3305|||||||Fisher Exact|||ACQ Improvement||||0.3305
91758085|NCT01455194|183409378|SUPERIORITY_OR_OTHER|||||||0.486|||||||Fisher Exact|||ACQ Improvement||||0.4860
91758086|NCT01455194|183409378|SUPERIORITY_OR_OTHER|||||||0.8922|||||||Fisher Exact|||ACQ Improvement||||0.8922
91758087|NCT01455194|183409379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.042|STANDARD_ERROR_OF_MEAN|0.0806||0.6062|TWO_SIDED|95.0|0.89|1.221|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.221|0.890|0.6062
91758088|NCT01455194|183409379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0669||0.4674|TWO_SIDED|95.0|0.921|1.197|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.197|0.921|0.4674
91758089|NCT01455194|183409379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.201|STANDARD_ERROR_OF_MEAN|0.1597||0.2523|TWO_SIDED|95.0|0.878|1.642|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.642|0.878|0.2523
91758090|NCT01455194|183409379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913|STANDARD_ERROR_OF_MEAN|0.1354||0.5026|TWO_SIDED|95.0|0.7|1.191|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.191|0.700|0.5026
91758091|NCT01455194|183409379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898|STANDARD_ERROR_OF_MEAN|0.156||0.4893|TWO_SIDED|95.0|0.661|1.219|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.219|0.661|0.4893
91758092|NCT01455194|183409379|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.181|STANDARD_ERROR_OF_MEAN|0.1351||0.2193|TWO_SIDED|95.0|0.906|1.538|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.538|0.906|0.2193
91758093|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.058|STANDARD_ERROR_OF_MEAN|0.0917||0.5397|TWO_SIDED|95.0|0.884|1.266|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.266|0.884|0.5397
91758094|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005|STANDARD_ERROR_OF_MEAN|0.0738||0.9458|TWO_SIDED|95.0|0.87|1.161|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.161|0.870|0.9458
91758095|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026|STANDARD_ERROR_OF_MEAN|0.0708||0.7213|TWO_SIDED|95.0|0.893|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.178|0.893|0.7213
91758096|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0692||0.4807|TWO_SIDED|95.0|0.917|1.202|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.202|0.917|0.4807
91758097|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326|STANDARD_ERROR_OF_MEAN|0.1791||0.115|TWO_SIDED|95.0|0.934|1.884|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.884|0.934|0.1150
91758098|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074|STANDARD_ERROR_OF_MEAN|0.1467||0.6281|TWO_SIDED|95.0|0.805|1.431|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.431|0.805|0.6281
91758099|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.059|STANDARD_ERROR_OF_MEAN|0.1415||0.6853|TWO_SIDED|95.0|0.803|1.397|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.397|0.803|0.6853
91758100|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055|STANDARD_ERROR_OF_MEAN|0.1388||0.6995|TWO_SIDED|95.0|0.804|1.385|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.385|0.804|0.6995
91758101|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.837|STANDARD_ERROR_OF_MEAN|0.1744||0.308|TWO_SIDED|95.0|0.595|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.178|0.595|0.3080
91758102|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939|STANDARD_ERROR_OF_MEAN|0.1461||0.6645|TWO_SIDED|95.0|0.705|1.25|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.250|0.705|0.6645
91758103|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992|STANDARD_ERROR_OF_MEAN|0.1408||0.9564|TWO_SIDED|95.0|0.753|1.308|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.308|0.753|0.9564
91758104|NCT01455194|183409380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|STANDARD_ERROR_OF_MEAN|0.1375||0.7367|TWO_SIDED|95.0|0.8|1.371|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.371|0.800|0.7367
91758105|NCT01455194|183409381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367|STANDARD_ERROR_OF_MEAN|0.2583||0.2264|TWO_SIDED|95.0|0.824|2.267|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.267|0.824|0.2264
91758106|NCT01455194|183409381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.102|STANDARD_ERROR_OF_MEAN|0.5001||0.1373|TWO_SIDED|95.0|0.789|5.602|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||5.602|0.789|0.1373
91758107|NCT01455194|183409381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882|STANDARD_ERROR_OF_MEAN|0.4365||0.7732|TWO_SIDED|95.0|0.375|2.074|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.074|0.375|0.7732
91758108|NCT01455194|183409382|SUPERIORITY_OR_OTHER|||||||0.288|||||||Fisher Exact|||||||0.2880
91758109|NCT01455194|183409382|SUPERIORITY_OR_OTHER|||||||0.2864|||||||Fisher Exact|||||||0.2864
91759902|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.44|||||TWO_SIDED|95.0|-25.53|-7.36||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.36|-25.53|
91759903|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.42|-0.34||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.34|-18.42|
91534562|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.29|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.29|0.943
91534563|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.89|1.62||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.62|0.89|<0.001
91759904|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.52|||||TWO_SIDED|95.0|-13.61|4.57||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.57|-13.61|
91759905|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.78|||||TWO_SIDED|95.0|-22.87|-4.69||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.69|-22.87|
91759906|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85|||||TWO_SIDED|95.0|-7.9|11.6||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.60|-7.90|
91759907|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|||||TWO_SIDED|95.0|-20.51|-0.93||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.93|-20.51|
91759908|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-28.28|-8.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.77|-28.28|
91759909|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-22.67|-3.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.25|-22.67|
91759910|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.46|||||TWO_SIDED|95.0|-17.21|2.3||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.30|-17.21|
91759911|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.24|||||TWO_SIDED|95.0|-26.0|-6.48||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.48|-26.00|
91759912|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.27|||||TWO_SIDED|95.0|5.34|21.2||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||21.20|5.34|
91759913|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.74|||||TWO_SIDED|95.0|-3.12|12.59||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.59|-3.12|
91759914|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-9.1|6.68||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.68|-9.10|
91759915|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-6.79|8.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.81|-6.79|
91759916|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.39|||||TWO_SIDED|95.0|4.39|22.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.38|4.39|
91759917|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|||||TWO_SIDED|95.0|-4.73|13.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.27|-4.73|
91759918|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-8.68|9.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.35|-8.68|
91759919|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.18|||||TWO_SIDED|95.0|-3.77|14.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.12|-3.77|
91758110|NCT00148941|183409402|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.97|||||TWO_SIDED|95.0|0.871|1.08|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.080|0.871|
91534564|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.85|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.85|<0.001
91758111|NCT00148941|183409402|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.961|||||TWO_SIDED|95.0|0.863|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.070|0.863|
91758112|NCT00148941|183409402|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.991|||||TWO_SIDED|95.0|0.89|1.103|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.103|0.890|
91758113|NCT00148941|183409402|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.975|||||TWO_SIDED|95.0|0.866|1.097|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.097|0.866|
91534565|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.847|TWO_SIDED|95.0|-0.27|0.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.27|0.847
91534566|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.59|||<|0.001|TWO_SIDED|95.0|1.14|2.05||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.05|1.14|<0.001
91534567|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.68|||<|0.001|TWO_SIDED|95.0|1.22|2.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.13|1.22|<0.001
91534568|NCT01362491|182947152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.08||||0.663|TWO_SIDED|95.0|-0.46|0.29||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - (Ibuprofen IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.29|-0.46|0.663
91534569|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.72||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.72|0.37|<0.001
91758114|NCT00148941|183409402|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.878|||||TWO_SIDED|95.0|0.78|0.988|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.988|0.780|
91758115|NCT00148941|183409402|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.901|||||TWO_SIDED|95.0|0.8|1.014|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.014|0.800|
91758116|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.938|||||TWO_SIDED|95.0|0.828|1.063|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.063|0.828|
91758117|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.963|||||TWO_SIDED|95.0|0.85|1.091|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.091|0.850|
91758118|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.026|||||TWO_SIDED|95.0|0.906|1.162|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.162|0.906|
91758119|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.874|||||TWO_SIDED|95.0|0.783|0.976|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.976|0.783|
91759920|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.56|||||TWO_SIDED|95.0|4.44|22.68||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.68|4.44|
91759921|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-7.64|10.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.64|-7.64|
91534570|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.51|||<|0.001|TWO_SIDED|95.0|0.33|0.69||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.33|<0.001
91534571|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.651|TWO_SIDED|95.0|-0.11|0.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.11|0.651
91534572|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.62|||<|0.001|TWO_SIDED|95.0|0.42|0.81||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.81|0.42|<0.001
91534573|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.65|||<|0.001|TWO_SIDED|95.0|0.46|0.85||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|0.46|<0.001
91534574|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.03||||0.669|TWO_SIDED|95.0|-0.19|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.19|0.669
91534575|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.57|<0.001
91758120|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.947|||||TWO_SIDED|95.0|0.849|1.057|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.057|0.849|
91758121|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.084|||||TWO_SIDED|95.0|0.971|1.209|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.209|0.971|
91758122|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.998|||||TWO_SIDED|95.0|0.867|1.148|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.148|0.867|
91758123|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.043|||||TWO_SIDED|95.0|0.907|1.2|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.200|0.907|
91758124|NCT00148941|183409403|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.045|||||TWO_SIDED|95.0|0.909|1.202|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.202|0.909|
91758125|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.994|||||TWO_SIDED|95.0|0.836|1.181|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.181|0.836|
91534576|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.67|1.21||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.21|0.67|<0.001
91534577|NCT01362491|182947153|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.396|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.396
91534578|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.8|||<|0.001|TWO_SIDED|95.0|1.3|2.3||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.30|1.30|<0.001
91534579|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.78|||<|0.001|TWO_SIDED|95.0|1.28|2.28||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.28|1.28|<0.001
91534580|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.911|TWO_SIDED|95.0|-0.39|0.43||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.43|-0.39|0.911
91534581|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.33|2.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.41|1.33|<0.001
91534582|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.34|2.42||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.42|1.34|<0.001
91534583|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.982|TWO_SIDED|95.0|-0.45|0.44||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.45|0.982
91758126|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.987|||||TWO_SIDED|95.0|0.831|1.172|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.172|0.831|
91758127|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.993|||||TWO_SIDED|95.0|0.836|1.18|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.180|0.836|
91759922|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.66|||||TWO_SIDED|95.0|-11.76|6.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.44|-11.76|
91759923|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.41|||||TWO_SIDED|95.0|-4.65|13.46||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.46|-4.65|
91759924|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.09|||||TWO_SIDED|95.0|8.34|27.84||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||27.84|8.34|
91534584|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.72|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.72|<0.001
91534585|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.61|||<|0.001|TWO_SIDED|95.0|1.9|3.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.33|1.90|<0.001
91758128|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.118|||||TWO_SIDED|95.0|0.951|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.951|
91759925|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.52|||||TWO_SIDED|95.0|-4.27|15.32||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.32|-4.27|
91512129|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.041|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.041
91512130|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.24|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.240
91512131|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.047|TWO_SIDED|95.0|0.0|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.0|0.047
91512132|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.228|TWO_SIDED|95.0|-0.5|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.5|0.228
91512133|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.1|0.030
91512134|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.059|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.059
91512135|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.021|TWO_SIDED|95.0|0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.2|0.021
91512136|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.428|TWO_SIDED|95.0|-0.6|1.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.6|0.428
91512137|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
91512138|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.1|0.064
91512139|NCT00406029|182896046|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.047|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.047
91512140|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.345|TWO_SIDED|95.0|-1.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.4|0.345
91512141|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.468|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.468
91512142|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.596|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.596
91512143|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.107|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.107
91512144|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.348|TWO_SIDED|94.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.348
91512145|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.938|TWO_SIDED|95.0|-1.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.1|0.938
91512146|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.897|TWO_SIDED|95.0|-1.1|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.1|0.897
91512147|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.518|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.518
91512148|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.311|TWO_SIDED|95.0|-2.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.2|0.311
91512149|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.597|TWO_SIDED|95.0|-1.0|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.0|0.597
91534586|NCT01362491|182947154|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.547|TWO_SIDED|95.0|-0.77|0.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.41|-0.77|0.547
91758129|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.006|||||TWO_SIDED|95.0|0.856|1.183|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.183|0.856|
91758130|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\] for Anti-poliovirus type 2.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.765|1.06|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.060|0.765|
91759926|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-12.03|7.46||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.46|-12.03|
91512150|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.925
91512151|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.478|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.478
91512152|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.995|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.5|0.995
91512153|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.057|TWO_SIDED|95.0|0.0|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.0|0.057
91512154|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.431|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.431
91512155|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.099|TWO_SIDED|95.0|-0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-0.2|0.099
91512156|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.847|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.847
91512157|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.093|TWO_SIDED|95.0|-0.2|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.2|0.093
91512158|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.471|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.471
91512159|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.102|TWO_SIDED|95.0|-0.2|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|-0.2|0.102
91512160|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.415|TWO_SIDED|95.0|-0.9|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.9|0.415
91512161|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.051|TWO_SIDED|95.0|0.0|3.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.0|0.0|0.051
91512162|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.103|TWO_SIDED|95.0|-0.3|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-0.3|0.103
91512163|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.022|TWO_SIDED|95.0|0.3|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|0.3|0.022
91512164|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.903|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.2|0.903
91512165|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.074|TWO_SIDED|95.0|-0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.1|0.074
91512166|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.185|TWO_SIDED|95.0|-0.4|2.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.4|0.185
91534587|NCT01362491|182947155|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.16|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
91534588|NCT01362491|182947155|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
91534589|NCT01362491|182947155|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.992|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.28|0.992
91758131|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.112|||||TWO_SIDED|95.0|0.941|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.941|
91758132|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.034|||||TWO_SIDED|95.0|0.876|1.22|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.220|0.876|
91758133|NCT00148941|183409404|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.93|||||TWO_SIDED|95.0|0.787|1.099|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.099|0.787|
91758134|NCT00148941|183409404|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ration|0.792|||||TWO_SIDED|95.0|0.68|0.922|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.922|0.680|
91758135|NCT00148941|183409404|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.696|0.925|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.925|0.696|
91758136|NCT00148941|183409404|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.938|||||TWO_SIDED|95.0|0.811|1.085|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.085|0.811|
91759927|NCT01393639|183411986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.28|||||TWO_SIDED|95.0|-6.42|12.98||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.98|-6.42|
91512167|NCT00406029|182896047|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.054|TWO_SIDED|95.0|0.0|2.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.0|0.054
91512168|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.985|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.985
91512169|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.556|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.3|0.556
91512170|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.776|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.776
91512171|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.777|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.777
91512172|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.92|TWO_SIDED|94.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.920
91512173|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.155|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.1|0.155
91512174|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.843|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.843
91512175|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.673|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.673
91512176|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.612|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.612
91512177|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.512|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.4|0.512
91512178|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.269|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.269
91512179|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.516|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.516
91512180|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.8|0.597
91512181|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.766|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.7|0.766
91512182|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.428|TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.9|0.428
91512183|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.796|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.7|0.796
91512184|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.988|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.988
91512185|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.786|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.786
91512186|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.702|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.702
91512187|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.371|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.371
91512188|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.981|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.981
91512189|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.282|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.282
91758137|NCT00148941|183409405|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.47|||||TWO_SIDED|95.0|-0.98|1.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.21|-0.98|
91534590|NCT01362491|182947155|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.01|||<|0.001|TWO_SIDED|95.0|1.43|2.58||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.58|1.43|<0.001
91534591|NCT01362491|182947155|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.68||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.68|1.53|<0.001
91759928|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.06|||||TWO_SIDED|95.0|-14.07|-0.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-14.07|
91512190|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.55|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.550
91512191|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.720
91512192|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.742|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.742
91512193|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.211|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.2|0.211
91512194|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.906|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.6|0.906
91512195|NCT00406029|182896048|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.868|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.868
91512196|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.747|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.747
91512197|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.140
91512198|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.148|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.148
91512199|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.005|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.2|0.005
91512200|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.256|TWO_SIDED|94.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.256
91512201|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.343|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.343
91512202|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.102|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.102
91512203|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.161|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.161
91512204|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.15|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.150
91759929|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.45|||||TWO_SIDED|95.0|-19.34|-5.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.56|-19.34|
91512205|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
91534592|NCT01362491|182947155|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.684|TWO_SIDED|95.0|-0.57|0.38||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.57|0.684
91758138|NCT00148941|183409405|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-2.81|||||TWO_SIDED|95.0|-6.55|-0.09||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|-0.09|-6.55|
91758139|NCT00148941|183409406|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.36|||||TWO_SIDED|95.0|-3.83|3.71||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.71|-3.83|
91758140|NCT00148941|183409406|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.79|||||TWO_SIDED|95.0|-2.5|3.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.21|-2.50|
91758141|NCT00148941|183409406|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-0.82|||||TWO_SIDED|95.0|-3.79|1.14||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.14|-3.79|
91758142|NCT00148941|183409407|NON_INFERIORITY|Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.|Difference in percentage|-0.41|||||TWO_SIDED|95.0|-1.26|0.16||||||Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves \> 50% of the length of the upper arm that also is associated with a \> 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.16|-1.26|
91758143|NCT01092663|183409440|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758144|NCT01092663|183409441|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758145|NCT01092663|183409442|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effects between the 2 groups||||>0.05
91758146|NCT01092663|183409443|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758147|NCT01092663|183409444|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758148|NCT01092663|183409445|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
91758149|NCT01092663|183409446|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Treament difference in fasting EGP between the 2 groups were compared.||||>0.05
91758150|NCT01092663|183409447|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between groups was evaluated||||>0.05
91512206|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.013|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.013
91534593|NCT01362491|182947156|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.85|3.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.17|1.85|<0.001
91758151|NCT01092663|183409448|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired ttest||Difference in treatment effect between groups was evaluated||||>0.05
91758152|NCT01092663|183409449|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758153|NCT01092663|183409450|SUPERIORITY_OR_OTHER||||||=|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||=0.01
91758154|NCT01092663|183409451|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||differerences in treatment effect between the 2 groups||||>0.05
91758155|NCT01092663|183409452|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758156|NCT01092663|183409453|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758157|NCT01092663|183409454|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758158|NCT01092663|183409455|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758159|NCT01092663|183409456|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
91758160|NCT01092663|183409457|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
91758161|NCT01092663|183409458|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
91758162|NCT01092663|183409459|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
91758163|NCT01092663|183409460|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
91758164|NCT00788710|183409461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91758165|NCT00788710|183409461|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91758166|NCT00788710|183409462|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91758167|NCT00788710|183409462|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91758168|NCT00788710|183409463|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91758169|NCT00788710|183409463|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91758170|NCT04407234|183409469|SUPERIORITY||Ratio of geometric least squares mean|0.881|||||TWO_SIDED|90.0|0.803|0.967|||Wilcoxon signed rank test|||||0.967|0.803|
91758171|NCT04407234|183409469|SUPERIORITY||Ratio of geometric least squares mean|1.16|||||TWO_SIDED|90.0|1.05|1.28|||Wilcoxon signed rank test|||||1.28|1.05|
91758172|NCT04407234|183409470|SUPERIORITY||Ratio of geometric least squares mean|0.446|||||TWO_SIDED|90.0|0.39|0.509|||Wilcoxon signed rank test|||||0.509|0.390|
91758173|NCT04407234|183409470|SUPERIORITY||Ratio of geometric least squares mean|0.679|||||TWO_SIDED|90.0|0.589|0.783|||Wilcoxon signed rank test|||||0.783|0.589|
91758174|NCT04407234|183409472|SUPERIORITY||Ratio of geometricleast squares mean|0.888|||||TWO_SIDED|90.0|0.778|1.01||||||||1.01|0.778|
91758175|NCT04407234|183409472|SUPERIORITY||Ratio of geometricleast squares mean|1.23|||||TWO_SIDED|90.0|1.07|1.42||||||||1.42|1.07|
91758176|NCT04407234|183409473|SUPERIORITY||Ratio of geometricleast squares mean|0.875|||||TWO_SIDED|90.0|0.766|0.999||||||||0.999|0.766|
91758177|NCT04407234|183409473|SUPERIORITY||Ratio of geometricleast squares mean|1.08|||||TWO_SIDED|90.0|0.938|1.25||||||||1.25|0.938|
91758178|NCT04407234|183409474|SUPERIORITY||Ratio of geometricleast squares mean|0.453|||||TWO_SIDED|90.0|0.376|0.545||||||||0.545|0.376|
91758179|NCT04407234|183409474|SUPERIORITY||Ratio of geometricleast squares mean|0.804|||||TWO_SIDED|90.0|0.66|0.979||||||||0.979|0.660|
91758180|NCT04407234|183409475|SUPERIORITY||Ratio of geometricleast squares mean|0.438|||||TWO_SIDED|90.0|0.364|0.527||||||||0.527|0.364|
91758181|NCT04407234|183409475|SUPERIORITY||Ratio of geometricleast squares mean|0.574|||||TWO_SIDED|90.0|0.471|0.698||||||||0.698|0.471|
91758182|NCT00727558|183409481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.554|STANDARD_ERROR_OF_MEAN|0.1943||||97.47|0.1721|0.554|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.554|0.1721|
91758183|NCT00727558|183409482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1734|STANDARD_ERROR_OF_MEAN|0.03555||||97.47|-0.1734|-0.1037|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||-0.1037|-0.1734|
91758184|NCT00727558|183409483|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3968|STANDARD_ERROR_OF_MEAN|0.1548||||98.7|0.04983|0.3968|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.3968|0.04983|
91758185|NCT00727558|183409484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3875|STANDARD_ERROR_OF_MEAN|0.2054||||98.7|0.03714|0.3875|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||0.3875|0.03714|
91758186|NCT00727558|183409485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6735|STANDARD_ERROR_OF_MEAN|0.1563||||98.7|0.213|0.6735|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.6735|0.213|
91758187|NCT00727558|183409486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.1648||||98.7|-0.2375|0.132|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.132|-0.2375|
91758188|NCT00727558|183409487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2469|STANDARD_ERROR_OF_MEAN|0.04448||||97.47|-0.2469|-0.1599|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining||-0.1599|-0.2469|
91758189|NCT02262754|183409491|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|0.16|||||TWO_SIDED|90.0|-0.28|0.6||||||An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.||0.60|-0.28|
91512207|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.12|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.120
91512208|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.971|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.971
91512209|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.456|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.456
91512210|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.018|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.018
91512211|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
91512212|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.422|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.3|0.422
91512213|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.651|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.651
91512214|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.096|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.096
91512215|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.860
91512216|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.511|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.8|0.511
91512217|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.286|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.286
91512218|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.004|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-1.4|0.004
91512219|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.06|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.060
91512220|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.345|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.345
91512221|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.439|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.439
91534594|NCT01362491|182947156|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.49|||<|0.001|TWO_SIDED|95.0|1.83|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.83|<0.001
91758190|NCT02262754|183409491|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.42|||||TWO_SIDED|90.0|-0.02|0.87||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.87|-0.02|
91758191|NCT02262754|183409491|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-0.26|||||TWO_SIDED|90.0|-0.7|0.18||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.18|-0.70|
91512222|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.004|TWO_SIDED|95.0|-1.4|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.4|0.004
91512223|NCT00406029|182896055|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.040
91512224|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.743|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.1|0.743
91512225|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.225|TWO_SIDED|95.0|-2.2|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.2|0.225
91512226|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.252|TWO_SIDED|95.0|-2.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.2|0.252
91512227|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.173|TWO_SIDED|95.0|-2.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-2.3|0.173
91512228|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|94.0|-1.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.3|0.757
91758192|NCT02262754|183409497|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.23|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.76|0.3||||||The ANCOVA model included treatment as fixed effects.||0.30|-0.76|
91758193|NCT02262754|183409497|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.41|0.65||||||The ANCOVA model included treatment as fixed effects.||0.65|-0.41|
91758194|NCT02262754|183409497|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.35|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.87|0.17||||||The ANCOVA model included treatment as fixed effects.||0.17|-0.87|
91758195|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.08|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.2|0.36||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.36|-0.20|
91512229|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.581|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.1|0.581
91512230|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.195|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.195
91512231|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.272|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.4|0.272
91512232|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.758|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.758
91512233|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.416|TWO_SIDED|95.0|-2.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.1|0.416
91512234|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.174|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.174
91512235|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.547|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-1.1|0.547
91512236|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.372|TWO_SIDED|95.0|-0.8|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.8|0.372
91512237|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.942|TWO_SIDED|95.0|-1.4|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.4|0.942
91512238|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.082|TWO_SIDED|95.0|-2.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.8|0.082
91512239|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.267|TWO_SIDED|95.0|-2.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.3|0.267
91512240|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.801|TWO_SIDED|95.0|-1.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.5|0.801
91512241|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.753|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.753
91512242|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.087|TWO_SIDED|95.0|-3.1|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-3.1|0.087
91512243|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.796|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.796
91534595|NCT01362491|182947156|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.943|TWO_SIDED|95.0|-0.52|0.56||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.52|0.943
91534596|NCT01362491|182947156|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.03|5.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|3.03|<0.001
91534597|NCT01362491|182947156|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.09|5.24||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.24|3.09|<0.001
91534598|NCT01362491|182947156|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.06||||0.888|TWO_SIDED|95.0|-0.95|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.95|0.888
91534599|NCT01362491|182947157|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.71|4.64||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.64|2.71|<0.001
91534600|NCT01362491|182947157|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.66|||<|0.001|TWO_SIDED|95.0|2.68|4.63||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.63|2.68|<0.001
91534601|NCT01362491|182947157|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.964|TWO_SIDED|95.0|-0.78|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.78|0.964
91534602|NCT01362491|182947157|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|6.27|||<|0.001|TWO_SIDED|95.0|4.65|7.89||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.89|4.65|<0.001
91534603|NCT01362491|182947157|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.16||||0.812|TWO_SIDED|95.0|-1.49|1.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.17|-1.49|0.812
91534604|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|12.02||||0.015|TWO_SIDED|95.0|5.27|18.77||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|5.27|0.015
91534605|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|4.5||||0.146|TWO_SIDED|95.0|0.13|8.88||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.88|0.13|0.146
91534606|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|7.62||||0.064|TWO_SIDED|95.0|-0.38|15.63||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.63|-0.38|0.064
91534607|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|58.58|||<|0.001|TWO_SIDED|95.0|44.96|72.21||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.21|44.96|<0.001
91534608|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|52.31|||<|0.001|TWO_SIDED|95.0|38.2|66.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||66.41|38.20|<0.001
91758196|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.48|0.07||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.07|-0.48|
91758197|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.28|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.01|0.56||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.56|0.01|
91512244|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
91534609|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|6.4||||0.357|TWO_SIDED|95.0|-7.27|20.07||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.07|-7.27|0.357
91534610|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|46.68|||<|0.001|TWO_SIDED|95.0|30.43|62.93||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.93|30.43|<0.001
91512245|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.784|TWO_SIDED|95.0|-1.8|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.8|0.784
91512246|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.024|TWO_SIDED|95.0|-3.5|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-3.5|0.024
91512247|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.963|TWO_SIDED|95.0|-1.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.6|0.963
91512248|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.331|TWO_SIDED|95.0|-0.8|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.8|0.331
91758198|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.43|0.34||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.34|-0.43|
91512249|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.898|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.898
91512250|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.058|TWO_SIDED|95.0|-3.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-3.0|0.058
91512251|NCT00406029|182896056|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.832|TWO_SIDED|95.0|-1.3|1.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.3|0.832
91512252|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.365|TWO_SIDED|95.0|-2.0|5.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.3|-2.0|0.365
91758199|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.24|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.62|0.15||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.15|-0.62|
91758200|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.19|0.58||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.58|-0.19|
91758201|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.39|0.45||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.45|-0.39|
91758202|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.27|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.69|0.16||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.16|-0.69|
91758203|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.3|STANDARD_ERROR_OF_MEAN|0.25||||90.0|-0.12|0.71||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.71|-0.12|
91758204|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.07|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.55||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.55|-0.40|
91758205|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.84|0.11||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.11|-0.84|
91758206|NCT02262754|183409498|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.91|-0.03|
91758207|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.03|0.08||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.08|-0.03|
91758208|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.09|0.02||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.02|-0.09|
91758209|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|0.01|0.12||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|0.01|
91758210|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.09|0.1||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.10|-0.09|
91758211|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.15|0.05||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.15|
91758212|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.04|0.15||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.15|-0.04|
91758213|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.12|0.12||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|-0.12|
91758214|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.16|0.07||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.07|-0.16|
91512253|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.476|TWO_SIDED|95.0|-2.4|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.4|0.476
91512254|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.343|TWO_SIDED|95.0|-2.0|5.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.6|-2.0|0.343
91512255|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.103|TWO_SIDED|95.0|-6.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-6.8|0.103
91512256|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.224|TWO_SIDED|94.0|-6.0|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.0|0.224
91512257|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.448|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.448
91512258|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7||||0.154|TWO_SIDED|95.0|-6.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.4|0.154
91512259|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-1.1|-8.5|0.010
91512260|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.54|TWO_SIDED|95.0|-2.6|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.6|0.540
91512261|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.646|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.7|0.646
91512262|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.608|TWO_SIDED|95.0|-4.9|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.9|0.608
91758215|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.07|0.16||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.16|-0.07|
91758216|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.01|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.16|0.14||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.14|-0.16|
91758217|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.24|0.05||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.24|
91758218|NCT02262754|183409499|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.05|0.23||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.23|-0.05|
91758219|NCT02262754|183409500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|90.0|0.54|1.73||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.73|0.54|
91512263|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.343|TWO_SIDED|95.0|-6.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-6.0|0.343
91512264|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.419|TWO_SIDED|95.0|-2.5|5.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.9|-2.5|0.419
91512265|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.562|TWO_SIDED|95.0|-2.8|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.8|0.562
91512266|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.525|TWO_SIDED|95.0|-5.3|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-5.3|0.525
91512267|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.0||||0.148|TWO_SIDED|95.0|-7.0|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-7.0|0.148
91512268|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.546|TWO_SIDED|95.0|-5.4|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-5.4|0.546
91512269|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.7||||0.068|TWO_SIDED|95.0|-7.6|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-7.6|0.068
91512270|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.5||||0.208|TWO_SIDED|95.0|-6.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.5|0.208
91534611|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|47.59|||<|0.001|TWO_SIDED|95.0|31.35|63.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.83|31.35|<0.001
91534612|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
91534613|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
91534614|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
91534615|NCT01362491|182947158|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
91534616|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|18.58||||0.002|TWO_SIDED|95.0|10.43|26.73||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.73|10.43|0.002
91758220|NCT02262754|183409500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|90.0|0.81|2.51||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.51|0.81|
91512271|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4||||0.099|TWO_SIDED|95.0|-7.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-7.5|0.099
91512272|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.731|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-3.6|0.731
91512273|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.861|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-4.5|0.861
91534617|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|7.8||||0.055|TWO_SIDED|95.0|2.14|13.46||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.46|2.14|0.055
91534618|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|10.91||||0.033|TWO_SIDED|95.0|0.98|20.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.83|0.98|0.033
91534619|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|62.03|||<|0.001|TWO_SIDED|95.0|48.65|75.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.41|48.65|<0.001
91758221|NCT02262754|183409500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68|||||TWO_SIDED|90.0|0.39|1.2||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.20|0.39|
91758222|NCT02262754|183409500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.37|1.81||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.81|0.37|
91758223|NCT02262754|183409500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|90.0|0.53|2.35||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.35|0.53|
91758224|NCT02262754|183409500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|90.0|0.33|1.6||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.60|0.33|
91512274|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.621|TWO_SIDED|95.0|-5.2|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-5.2|0.621
91512275|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.288|TWO_SIDED|95.0|-6.4|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-6.4|0.288
91534620|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|59.44|||<|0.001|TWO_SIDED|95.0|45.69|73.19||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.19|45.69|<0.001
91534621|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|2.96||||0.642|TWO_SIDED|95.0|-9.52|15.44||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.44|-9.52|0.642
91534622|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
91534623|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
91534624|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
91534625|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
91534626|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
91758225|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.18|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.06|0.7||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.70|-1.06|
91758226|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.91|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.8|-0.03||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.03|-1.80|
91534627|NCT01362491|182947159|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
91534628|NCT01362491|182947162|SUPERIORITY_OR_OTHER||Difference in proportion|3.21||||0.389|TWO_SIDED|95.0|-3.12|9.55||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.55|-3.12|0.389
91534629|NCT01362491|182947162|SUPERIORITY_OR_OTHER||Difference in proportion|2.35||||0.49|TWO_SIDED|95.0|-3.69|8.39||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.39|-3.69|0.490
91534630|NCT01362491|182947162|SUPERIORITY_OR_OTHER||Difference in proportion|0.98||||0.764|TWO_SIDED|95.0|-5.45|7.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.41|-5.45|0.764
91758227|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.73|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.15|1.61||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.61|-0.15|
91534631|NCT01362491|182947162|SUPERIORITY_OR_OTHER||Difference in proportion|28.71|||<|0.001|TWO_SIDED|95.0|15.72|41.7||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.70|15.72|<0.001
91534632|NCT01362491|182947162|SUPERIORITY_OR_OTHER||Difference in proportion|29.37|||<|0.001|TWO_SIDED|95.0|16.19|42.56||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.56|16.19|<0.001
91534633|NCT01362491|182947162|SUPERIORITY_OR_OTHER||Difference in proportion|-0.93||||0.898|TWO_SIDED|95.0|-15.22|13.36||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|-15.22|0.898
91534634|NCT01289119|182947184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.78|-0.37|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.37|-0.78|<0.001
91534635|NCT01289119|182947184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.51||ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates.|ANCOVA|||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.51|-0.87|<0.001
91534636|NCT01289119|182947184|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.28|-0.75|<0.001
91534637|NCT01704846|182947196|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.47|||||TWO_SIDED|90.0|95.9|105.25|||||Ratio calculated as Test product divided by reference product|||105.25|95.90|
91534638|NCT01704846|182947197|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|102.99|||||TWO_SIDED|90.0|95.57|110.98|||||Ratio calculated as Test product divided by reference product|||110.98|95.57|
91534639|NCT01704846|182947198|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.54|||||TWO_SIDED|90.0|96.1|105.18|||||Ratio calculated as Test product divided by reference product|||105.18|96.10|
91534640|NCT01704846|182947199|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.|Adjusted Mean Ratio (%)|97.66|||||TWO_SIDED|90.0|91.54|103.78|||||Ratio calculated as Test product divided by reference product|||103.78|91.54|
91534641|NCT01704846|182947200|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.34|||||TWO_SIDED|90.0|98.51|102.2|||||Ratio calculated as Test product divided by reference product|||102.20|98.51|
91534642|NCT01704846|182947201|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|99.66|||||TWO_SIDED|90.0|97.85|101.51|||||Ratio calculated as Test product divided by reference product|||101.51|97.85|
91534643|NCT01704846|182947202|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.2|||||TWO_SIDED|90.0|98.1|102.34|||||Ratio calculated as Test product divided by reference product|||102.34|98.10|
91534644|NCT02584790|182947233|OTHER|||||||0.004|||||||Chi-squared|||2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual disease||||0.004
91534645|NCT02072226|182947269|OTHER|Confidence Interval|Adjusted Risk Difference|-1.1|||||TWO_SIDED|95.0|-9.44|7.25||||||||7.25|-9.44|
91534646|NCT02072226|182947270|OTHER|Confidence Interval|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.527|1.244||||||||1.244|0.527|
91534647|NCT02072226|182947271|OTHER|Confidence Interval|Odds Ratio (OR)|0.858|||||TWO_SIDED|95.0|0.529|1.393||||||||1.393|0.529|
91534648|NCT02072226|182947272|OTHER|Confidence Interval|difference in percentages|3.25|||||TWO_SIDED|95.0|0.75|7.38||||||||7.38|0.75|
91534649|NCT02072226|182947273|OTHER|Confidence Interval|difference in percentages|4.53|||||TWO_SIDED|95.0|-0.34|10.07||||||Any ICH within 36 hours reported by site||10.07|-0.34|
91512276|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.861|TWO_SIDED|95.0|-3.5|4.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.1|-3.5|0.861
91512277|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.954|TWO_SIDED|95.0|-4.0|3.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.0|0.954
91512278|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6||||0.419|TWO_SIDED|95.0|-5.5|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-5.5|0.419
91534650|NCT02072226|182947273|OTHER|Confidence Interval|difference in percentages|3.87|||||TWO_SIDED|95.0|-1.23|9.49||||||Any ICH within 36 hours reported by central reader||9.49|-1.23|
91534651|NCT00810303|182947282|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534652|NCT00810303|182947283|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534653|NCT00810303|182947285|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
91534654|NCT00810303|182947286|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
91534655|NCT00810303|182947287|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
91534656|NCT00810303|182947287|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
91534657|NCT00810303|182947288|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
91534658|NCT00810303|182947289|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
91534659|NCT00810303|182947290|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
91534660|NCT00810303|182947290|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
91534661|NCT00810303|182947291|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534662|NCT00810303|182947291|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
91534663|NCT00810303|182947292|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91758228|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.7|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.69|0.29||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.29|-1.69|
91534664|NCT00810303|182947292|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534665|NCT00810303|182947293|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
91534666|NCT00810303|182947293|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534667|NCT00810303|182947294|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
91534668|NCT00810303|182947295|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534669|NCT00810303|182947296|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
91534670|NCT00810303|182947296|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
91534671|NCT01720043|182947297|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||Collagen.5.g.ml, 24 hrs||||0.181
91534672|NCT01720043|182947297|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Collagen.2.g.ml||||.164
91534673|NCT01720043|182947297|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||ADP.10.M, 24 hrs||||.132
91534674|NCT01720043|182947297|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||ADP.5.M||||.066
91534675|NCT01720043|182947297|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||ADP.3.M, 24 hrs||||0.268
91534676|NCT01720043|182947297|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml||||0.106
91534677|NCT01720043|182947297|SUPERIORITY|||||||0.625|||||||t-test, 2 sided|||Ristocetin.1.5.mg.ml||||0.625
91758229|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.11|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.11|-2.11|
91534678|NCT01720043|182947297|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml||||0.381
91758230|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.41|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.57|1.39||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.39|-0.57|
91758231|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.41|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-1.42|0.6||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.60|-1.42|
91534679|NCT01720043|182947297|SUPERIORITY|||||||0.549|||||||t-test, 2 sided|||Collagen.5.g.ml, 48 hrs||||0.549
91534680|NCT01720043|182947297|SUPERIORITY|||||||0.838|||||||t-test, 2 sided|||Collagen.2.g.ml, 48 hrs||||.838
91534681|NCT01720043|182947297|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||ADP.10.M||||0.245
91534682|NCT01720043|182947297|SUPERIORITY|||||||0.417|||||||t-test, 2 sided|||ADP.5.M||||0.417
91534683|NCT01720043|182947297|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||ADP.3.M, 48 hrs||||0.770
91534684|NCT01720043|182947297|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml, 48 hrs||||0.614
91534685|NCT01720043|182947297|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||Ristochetin.1.5.mg.ml||||0.969
91534686|NCT01720043|182947297|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml, 48 hrs||||0.238
91534687|NCT02796092|182947298|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.||||>0.999
91758232|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.27|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-2.28|-0.27||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.27|-2.28|
91534688|NCT02796092|182947299|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.3
91534689|NCT02796092|182947300|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91534690|NCT02796092|182947301|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91534691|NCT02796092|182947302|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
91534692|NCT02796092|182947303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91534693|NCT02796092|182947304|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91758233|NCT02262754|183409506|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.86|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-0.12|1.85||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.85|-0.12|
91758234|NCT02262754|183409507|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|-0.64|||||TWO_SIDED|90.0|-1.63|0.35||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||0.35|-1.63|
91758235|NCT02262754|183409507|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-1.43|||||TWO_SIDED|90.0|-2.4|-0.45||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||-0.45|-2.40|
91758236|NCT02262754|183409507|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.79|||||TWO_SIDED|90.0|-0.22|1.8||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||1.80|-0.22|
91534694|NCT02796092|182947305|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91534695|NCT02796092|182947306|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91534696|NCT02796092|182947307|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91534697|NCT02796092|182947308|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91534698|NCT02796092|182947309|SUPERIORITY_OR_OTHER|||||||0.0499|||||||Chi-squared|||||||0.0499
91534699|NCT02796092|182947311|SUPERIORITY_OR_OTHER|||||||0.095|||||||Fisher Exact|||||||0.095
91534700|NCT02467491|182947316|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-test||||0.04
91534701|NCT02467491|182947317|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-test||||0.02
91534702|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-4.3|12.3|||||RD is for retention 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||12.3|-4.3|
91758237|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-1.52|0.78||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.78|-1.52|
91758238|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.95|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-2.1|0.2||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.20|-2.10|
91758239|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.58|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-0.56|1.71||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.71|-0.56|
91758240|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-1.02|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.06|0.02||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-2.06|
91512279|NCT00406029|182896057|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.088|TWO_SIDED|95.0|-6.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.9|0.088
91512280|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.924|TWO_SIDED|95.0|-3.5|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|-3.5|0.924
91512281|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.84|TWO_SIDED|95.0|-3.8|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-3.8|0.840
91512282|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.599|TWO_SIDED|95.0|-4.4|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.4|0.599
91512283|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.6||||0.134|TWO_SIDED|95.0|-6.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-6.0|0.134
91512284|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.846|TWO_SIDED|94.0|-4.1|3.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.3|-4.1|0.846
91512285|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.467|TWO_SIDED|95.0|-2.3|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.3|0.467
91512286|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.533|TWO_SIDED|95.0|-4.8|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.8|0.533
91512287|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.094|TWO_SIDED|95.0|-6.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.7|0.094
91512288|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.994|TWO_SIDED|95.0|-3.7|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-3.7|0.994
91512289|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.944|TWO_SIDED|95.0|-3.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.5|0.944
91512290|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.424|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.424
91512291|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.0||||0.042|TWO_SIDED|95.0|-7.8|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-7.8|0.042
91512292|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|3.7||||0.075|TWO_SIDED|95.0|-0.4|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|-0.4|0.075
91512293|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|3.9||||0.052|TWO_SIDED|95.0|0.0|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|0.0|0.052
91512294|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.975|TWO_SIDED|95.0|-4.0|3.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.9|-4.0|0.975
91512295|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.541|TWO_SIDED|95.0|-5.2|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-5.2|0.541
91758241|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.21|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.25|-0.17||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.17|-2.25|
91758242|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-0.82|1.19||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.19|-0.82|
91758243|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-1.39|-0.15||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.15|-1.39|
91758244|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-0.8|0.45||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.45|-0.80|
91758245|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.6|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-1.21|0.02||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-1.21|
91758246|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.85|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.42|-0.28||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.28|-1.42|
91512296|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.931|TWO_SIDED|95.0|-4.1|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.1|0.931
91758247|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.67|0.46||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.46|-0.67|
91758248|NCT02262754|183409508|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.74|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-1.29|-0.2||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.20|-1.29|
91758249|NCT02262754|183409509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|90.0|0.61|1.58||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||1.58|0.61|
91758250|NCT02262754|183409509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|90.0|1.33|3.14||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||3.14|1.33|
91758251|NCT02262754|183409509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||||TWO_SIDED|90.0|0.31|0.74||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||0.74|0.31|
91758252|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.19|0.2||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.20|-0.19|
91758253|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.34|0.05||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.34|
91758254|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.15|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.05|0.35||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.35|-0.05|
91758255|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.18|-0.26|
91534703|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|9.1|||||TWO_SIDED|95.0|0.9|17.2|||||RD is for retention 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||17.2|0.9|
91534704|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|1.0|9.1|||||RD is for retention 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||9.1|1|
91534705|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.8|1.6|||||RD is for transfer 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||1.6|-0.8|
91534706|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for transfer 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
91534707|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-1.7|0.7|||||RD is for transfer 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.7|-1.7|
91534708|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||RD is for death 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.2|-0.4|
91534709|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for death 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
91534710|NCT03101592|182947353|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||RD is for death 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.3|-0.3|
91534711|NCT01970943|182947357|OTHER||Mean Difference (Final Values)|0.6078||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91534712|NCT01970943|182947359|OTHER||Mean Difference (Final Values)|0.037786||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
91534713|NCT01352507|182947366|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilson Score method|||Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).||||<0.001
91534714|NCT01352507|182947368|SUPERIORITY_OR_OTHER||Least Squares (LS) mean difference|0.02||||0.793|TWO_SIDED|95.0|-0.11|0.15||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.15|-0.11|0.793
91534715|NCT01352507|182947369|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.988|TWO_SIDED|95.0|-1.35|1.37||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||1.37|-1.35|0.988
91534716|NCT01352507|182947370|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.102|TWO_SIDED|95.0|-0.01|0.08||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.08|-0.01|0.102
91534717|NCT01352507|182947372|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.861|TWO_SIDED|95.0|-0.22|0.19||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.19|-0.22|0.861
91534718|NCT01352507|182947373|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.495|TWO_SIDED|95.0|-0.19|0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.09|-0.19|0.495
91534719|NCT01352507|182947374|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.917|TWO_SIDED|95.0|-0.18|0.16||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.16|-0.18|0.917
91534720|NCT01352507|182947375|SUPERIORITY_OR_OTHER||LS mean difference|1.23||||0.391|TWO_SIDED|95.0|-1.58|4.04||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||4.04|-1.58|0.391
91534721|NCT01352507|182947376|SUPERIORITY_OR_OTHER||LS mean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.18|0.09|<0.001
91534722|NCT01352507|182947377|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.19|-0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||-0.09|-0.19|<0.001
91534723|NCT01352507|182947378|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.364|TWO_SIDED|95.0|-0.2|0.55||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.55|-0.20|0.364
91534724|NCT01018511|182947397|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Overall power was 90% power for non-inferiority vs placebo for total IPSS. Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|97.5|-1.73|0.11||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.11|-1.73|0.001
91534725|NCT01018511|182947397|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.028|TWO_SIDED|97.5|-1.22|0.64||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.64|-1.22|0.028
91534726|NCT01018511|182947397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.048
91534727|NCT01018511|182947397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.483
91512297|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.618|TWO_SIDED|95.0|-4.7|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-4.7|0.618
91512298|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.8||||0.341|TWO_SIDED|95.0|-5.6|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-5.6|0.341
91512299|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.256|TWO_SIDED|95.0|-6.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-6.0|0.256
91512300|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.399|TWO_SIDED|95.0|-2.4|6.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||6.0|-2.4|0.399
91512301|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.477|TWO_SIDED|95.0|-2.5|5.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.4|-2.5|0.477
91512302|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.172|TWO_SIDED|95.0|-6.8|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-6.8|0.172
91512303|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.254|TWO_SIDED|95.0|-6.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-6.2|0.254
91512304|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.972|TWO_SIDED|95.0|-3.6|3.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.6|0.972
91512305|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.891|TWO_SIDED|95.0|-3.5|4.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.0|-3.5|0.891
91512306|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.143|TWO_SIDED|95.0|-6.6|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.6|0.143
91512307|NCT00406029|182896058|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.083|TWO_SIDED|95.0|-6.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-6.8|0.083
91512308|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.154|TWO_SIDED|95.0|-0.2|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.2|0.154
91512309|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.38|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.380
91512310|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.288|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.3|0.288
91512311|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.355|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.355
91512312|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.831|TWO_SIDED|94.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.831
91512313|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.198|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-1.2|0.198
91512314|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.792|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.792
91512315|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.749|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.749
91512316|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.896|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.896
91512317|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.480
91512318|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.285|TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.4|0.285
91512319|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.212|TWO_SIDED|95.0|-0.3|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.3|0.212
91512320|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.883|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.9|0.883
91512321|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.947|TWO_SIDED|95.0|-0.9|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.9|0.947
91534728|NCT01018511|182947397|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.9||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.9|-2.4|<0.001
91758256|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.37|0.07||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.07|-0.37|
91758257|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.33||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.33|-0.10|
91758258|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.09|0.38||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.09|
91512322|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.1|0.663
91512323|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.157|TWO_SIDED|95.0|-0.3|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.3|0.157
91512324|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.283|TWO_SIDED|95.0|-1.4|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.4|0.283
91512325|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.768|TWO_SIDED|95.0|-1.0|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.0|0.768
91512326|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.334|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.334
91512327|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.465|TWO_SIDED|95.0|-1.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.2|0.465
91512328|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.688|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.688
91512329|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.062|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.062
91512330|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.579|TWO_SIDED|95.0|-1.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.2|0.579
91512331|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.644|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.644
91758259|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.02|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.21|0.25||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.25|-0.21|
91758260|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.1|0.36||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.36|-0.10|
91758261|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.13|0.38||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.13|
91758262|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.21|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.46|0.05||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.46|
91758263|NCT02262754|183409510|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.08|0.58||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.58|0.08|
91534729|NCT01018511|182947397|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.006|TWO_SIDED|95.0|-1.9|-0.3||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs. placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.3|-1.9|0.006
91534730|NCT01018511|182947397|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.039|TWO_SIDED|95.0|-1.6|0.0||No adjustments for multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in total IPSS. With a sample size of 274 participants per arm, the overall power to meet this outcome measure was 97% power for superiority vs placebo for total IPSS.||-0.0|-1.6|0.039
91534731|NCT01018511|182947398|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||0.025|TWO_SIDED|97.5|-2.9|0.0||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.0|-2.9|0.025
91534732|NCT01018511|182947398|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.162|TWO_SIDED|97.5|-2.3|0.5||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.5|-2.3|0.162
91534733|NCT01018511|182947398|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-4.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. placebo on the change from baseline to end of treatment in TUS.||-2.5|-4.9|<0.001
91534734|NCT01018511|182947398|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.4|-1.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/9 mg vs. placebo on the change from baseline to end of treatment in TUS.||-1.9|-4.4|<0.001
91534735|NCT01018511|182947398|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in TUS.||-1.0|-3.5|<0.001
91534736|NCT01018511|182947399|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.3|-1.0|<0.001
91534737|NCT01018511|182947399|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.1|-0.6|0.223
91534738|NCT01018511|182947399|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.8|-1.5|< 0.001
91758264|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.42|0.08||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.08|-0.42|
91758265|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.62|-0.12||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.62|
91758266|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.05|0.45||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.45|-0.05|
91758267|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.21||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.38|
91758268|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.29|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.58|0.01||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.01|-0.58|
91512332|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.825|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.825
91512333|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.233|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.233
91512334|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.853|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.853
91534739|NCT01018511|182947399|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-0.4|-1.1|< 0.001
91534740|NCT01018511|182947399|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.9|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.9|0.002
91534741|NCT01018511|182947400|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|16.6|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|16.6|< 0.001
91534742|NCT01018511|182947400|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|16.6|29.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.8|16.6|< 0.001
91534743|NCT01018511|182947400|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.4|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|21.0|33.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.9|21.0|< 0.001
91534744|NCT01018511|182947400|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.6|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|21.1|34.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||34.1|21.1|< 0.001
91534745|NCT01018511|182947400|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|3.32||0.189|TWO_SIDED|95.0|-2.2|10.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||10.9|-2.2|0.189
91534746|NCT01018511|182947401|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.5|STANDARD_ERROR_OF_MEAN|7.51||0.053|TWO_SIDED|95.0|-0.2|29.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.3|-0.2|0.053
91534747|NCT01018511|182947401|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.7|STANDARD_ERROR_OF_MEAN|7.59||0.053|TWO_SIDED|95.0|-0.2|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|-0.2|0.053
91534748|NCT01018511|182947401|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.5|STANDARD_ERROR_OF_MEAN|7.37||0.012|TWO_SIDED|95.0|4.1|33.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.0|4.1|0.012
91534749|NCT01018511|182947401|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.7|STANDARD_ERROR_OF_MEAN|7.45||0.012|TWO_SIDED|95.0|4.1|33.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.4|4.1|0.012
91758269|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.49||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.49|-0.09|
91534750|NCT01018511|182947401|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|7.49||0.591|TWO_SIDED|95.0|-10.7|18.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||18.7|-10.7|0.591
91534751|NCT01018511|182947402|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.616|TWO_SIDED|95.0|-0.6|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.4|-0.6|0.616
91534752|NCT01018511|182947402|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.319|TWO_SIDED|95.0|-0.7|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.7|0.319
91758270|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.36|0.21||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.36|
91758271|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.38|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.67|-0.1||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.10|-0.67|
91758272|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.31|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.03|0.59||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.59|0.03|
91758273|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.42|0.21||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.42|
91534753|NCT01018511|182947402|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.5|-0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.6|-1.5|< 0.001
91534754|NCT01018511|182947402|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.7|< 0.001
91534755|NCT01018511|182947402|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.4|-0.4||No adjustments to multiplicity were made|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.4|-1.4|< 0.001
91534756|NCT01018511|182947403|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.591|TWO_SIDED|95.0|-0.3|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.5|-0.3|0.591
91534757|NCT01018511|182947403|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.102|TWO_SIDED|95.0|-0.1|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.1|0.102
91534758|NCT01018511|182947403|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.204|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.6|0.204
91534759|NCT01018511|182947403|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.936|TWO_SIDED|95.0|-0.4|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-0.4|0.936
91534760|NCT01018511|182947403|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.081|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.8|0.081
91758274|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.43|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.75|-0.12||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.75|
91758275|NCT02262754|183409511|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.02|0.63||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.63|0.02|
91534761|NCT01018511|182947404|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.24||0.511|TWO_SIDED|95.0|-0.3|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.3|0.511
91534762|NCT01018511|182947404|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.182|TWO_SIDED|95.0|-0.2|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.2|0.182
91534763|NCT01018511|182947404|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.552|TWO_SIDED|95.0|-0.6|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.6|0.552
91534764|NCT01018511|182947404|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.891|TWO_SIDED|95.0|-0.4|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo||0.5|-0.4|0.891
91534765|NCT01018511|182947404|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.215|TWO_SIDED|95.0|-0.8|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.8|0.215
91758276|NCT02262754|183409512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|90.0|0.46|1.56||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||1.56|0.46|
91758277|NCT02262754|183409512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||||TWO_SIDED|90.0|0.23|0.81||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||0.81|0.23|
91758278|NCT02262754|183409512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|90.0|1.06|3.65||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||3.65|1.06|
91758279|NCT00223704|183409515|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||This P-value is for the main comparison of receiving any transfusion.|Chi-squared|||||||0.72
91758280|NCT00223704|183409516|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.88
91758281|NCT00223704|183409517|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.43
91758282|NCT00223704|183409518|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||The P-value reflects the difference in Interleukin-6 concentrations among the 3 treatment groups over the course of the study (baseline, post-bypass, postoperative day 1 and 2)|Mixed Models Analysis|||The time course for Interleukin-6 concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||0.92
91534766|NCT01018511|182947405|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.383|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||0.1|-0.2|0.383
91758283|NCT00223704|183409519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value reflects the difference in D-dimer concentrations among the 3 treatment groups over the course of the study (baseline, 30min, 60min, post-bypass, and postoperative day 1)|Mixed Models Analysis|||The time course for D-dimer concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||<0.001
91758284|NCT02126839|183409529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.02|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|16.1|33.94|||mixed model repeated measures analysis|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||33.94|16.10|<0.0001
91534767|NCT01018511|182947405|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.402|TWO_SIDED|95.0|-0.1|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.1|0.402
91534768|NCT01018511|182947405|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.0|-0.3|0.021
91758285|NCT02126839|183409530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.33|STANDARD_ERROR_OF_MEAN|14.47|<|0.0001|TWO_SIDED|95.0|47.76|104.91|||mixed model repeated measures|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||104.91|47.76|<0.0001
91758286|NCT00826618|183409600|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||Compare final visual acuity to baseline visual acuity||||0.0015
91758287|NCT01496469|183409655|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.882|TWO_SIDED|95.0|-3.9|3.4||Analysis of covariance (ANCOVA) model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|ANCOVA|||A total of 120 enrolled participants (60 participants per treatment group) was sufficient to achieve 80 percent (%) power to detect a difference of 6.0 mmHg between the placebo and febuxostat 80 mg treatment groups by a 2 sample t-test of the mean change from Baseline at Week 6 in 24-hour mean ambulatory SBP with a 2-sided significance level of 5%.||3.4|-3.9|0.882
91758288|NCT01496469|183409656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6||||0.613|TWO_SIDED|95.0|-1.9|3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||3.2|-1.9|0.613
91758289|NCT01496469|183409657|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-3.9|-2.9||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||-2.9|-3.9|<0.001
91758290|NCT02219334|183409664|EQUIVALENCE|Historical data at the institution for similar patients had a mean length of stay(LOS) of 25.7 hours (standard deviation-\[SD\] =10.3) from 9/2012- 9/13 was observed for 134 patients admitted to the emergency department observation unit and treated with the standard of care (NeoSucker). Given a LOS-SD of 10.3 hours, 75 subjects per treatment group would provide 80% statistical power at the 5% significance level to demonstrate equivalence in the two treatments' length of stay within ±5 hours.|Mean Difference (Final Values)|2.49|STANDARD_DEVIATION|21.4|<|0.05|TWO_SIDED|95.0|-10.74|15.72|||two one-sided t-test (TOST)||Due to slower than anticipated patient recruitment, the target size of 75 participants per treatment group was not reached.|The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.||15.72|-10.74|<0.05
91758291|NCT02381015|183409668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
91758292|NCT02381015|183409669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||Chi-squared|||||||0.35
91758293|NCT02381015|183409670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
91758294|NCT02381015|183409671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Kruskal-Wallis|||||||0.49
91758295|NCT02381015|183409672|OTHER||Beta|93.5|STANDARD_ERROR_OF_MEAN|1.55||0.42|TWO_SIDED||||||ANOVA|||The statistical analysis shows the relation between risk given and risk recall at the immediate post results assessment for the total number of participants.||||0.42
91758296|NCT02381015|183409673|OTHER||Beta|94.7|STANDARD_ERROR_OF_MEAN|2.93||0.33|TWO_SIDED||||||ANOVA|||||||0.33
91758297|NCT00930553|183409702|SUPERIORITY_OR_OTHER||Percentage with SAD|22.33|||||TWO_SIDED|95.0|18.33|27.06|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||27.06|18.33|
91758298|NCT00930553|183409702|SUPERIORITY_OR_OTHER||Percentage with SAD|29.69|||||TWO_SIDED|95.0|25.42|34.49|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||34.49|25.42|
91758299|NCT00930553|183409703|SUPERIORITY_OR_OTHER||Percentage with SAD|9.35|||||TWO_SIDED|95.0|5.54|15.56|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||15.56|5.54|
91758300|NCT00930553|183409703|SUPERIORITY_OR_OTHER||Percentage with SAD|7.95|||||TWO_SIDED|95.0|4.48|13.9|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||13.90|4.48|
91758301|NCT00930553|183409703|SUPERIORITY_OR_OTHER||Percentage with SAD|20.42|||||TWO_SIDED|95.0|14.67|28.03|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||28.03|14.67|
91758302|NCT00930553|183409703|SUPERIORITY_OR_OTHER||Percentage with SAD|11.99|||||TWO_SIDED|95.0|7.63|18.58|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||18.58|7.63|
91758303|NCT00930553|183409704|SUPERIORITY_OR_OTHER||Percentage with SRD|32.69|||||TWO_SIDED|95.0|26.96|39.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||39.28|26.96|
91534769|NCT01018511|182947405|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.584|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.2|0.584
91534770|NCT01018511|182947405|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.166|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.166
91534771|NCT01018511|182947406|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.187
91534772|NCT01018511|182947406|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.203|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.203
91534773|NCT01018511|182947406|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.09|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.090
91534774|NCT01018511|182947406|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.098|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.098
91534775|NCT01018511|182947406|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.772|TWO_SIDED|95.0|-0.7|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.5|-0.7|0.772
91534776|NCT01018511|182947407|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.21|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.9|0.210
91534777|NCT01018511|182947407|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.775|TWO_SIDED|95.0|-0.5|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.5|0.775
91534778|NCT01018511|182947407|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.01|TWO_SIDED|95.0|-1.2|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-1.2|0.010
91534779|NCT01018511|182947407|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.317|TWO_SIDED|95.0|-0.8|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.8|0.317
91534780|NCT01018511|182947407|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.196|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.9|0.196
91534781|NCT01018511|182947408|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.009|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.9|0.009
91534782|NCT01018511|182947408|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.045|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.8|0.045
91534783|NCT01018511|182947408|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.4|< 0.001
91534784|NCT01018511|182947408|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.1|-0.9|0.011
91758304|NCT00930553|183409704|SUPERIORITY_OR_OTHER||Percentage with SRD|42.46|||||TWO_SIDED|95.0|37.08|48.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||48.28|37.08|
91758305|NCT00930553|183409705|SUPERIORITY_OR_OTHER||Percentage with SRD|16.92|||||TWO_SIDED|95.0|9.75|28.47|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||28.47|9.75|
91758306|NCT00930553|183409705|SUPERIORITY_OR_OTHER||Percentage with SRD|13.89|||||TWO_SIDED|95.0|8.47|22.33|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||22.33|8.47|
91758307|NCT02967510|183409738|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.304|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.304
91534785|NCT01018511|182947408|SUPERIORITY_OR_OTHER_LEGACY||Least squares men difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.5|-1.3|< 0.001
91534786|NCT01018511|182947409|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.5|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.5|0.008
91534787|NCT01018511|182947409|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.021|TWO_SIDED|95.0|-0.4|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.4|0.021
91534788|NCT01018511|182947409|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
91534789|NCT01018511|182947409|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
91534790|NCT01018511|182947409|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.139|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.139
91534791|NCT01018511|182947411|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.14||0.068|TWO_SIDED|95.0|-4.3|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-4.3|0.068
91534792|NCT01018511|182947411|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.7|STANDARD_DEVIATION|1.15||0.02|TWO_SIDED|95.0|-4.9|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.4|-4.9|0.020
91534793|NCT01018511|182947411|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-2.5|-6.9|< 0.001
91758308|NCT02967510|183409738|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.109|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.109
91534794|NCT01018511|182947411|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-7.5|-3.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-3.1|-7.5|< 0.001
91534795|NCT01018511|182947411|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.14||0.022|TWO_SIDED|95.0|-4.8|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-4.8|0.022
91534796|NCT01018511|182947412|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.16||0.011|TWO_SIDED|95.0|0.7|5.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||5.2|0.7|0.011
91534797|NCT01018511|182947412|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|1.17||0.035|TWO_SIDED|95.0|0.2|4.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.8|0.2|0.035
91534798|NCT01018511|182947412|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|2.8|7.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||7.3|2.8|< 0.001
91534799|NCT01018511|182947412|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.6|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.3|6.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.8|2.3|< 0.001
91534800|NCT01018511|182947412|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.16||0.068|TWO_SIDED|95.0|-0.2|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.4|-0.2|0.068
91534801|NCT01018511|182947413|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.07||0.013|TWO_SIDED|95.0|0.5|4.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.7|0.5|0.013
91534802|NCT01018511|182947413|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.08||0.043|TWO_SIDED|95.0|0.1|4.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.3|0.1|0.043
91534803|NCT01018511|182947413|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|2.4|6.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.5|2.4|< 0.001
91534804|NCT01018511|182947413|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.9|6.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.1|1.9|< 0.001
91534805|NCT01018511|182947413|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.06||0.092|TWO_SIDED|95.0|-0.3|3.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.9|-0.3|0.092
91534806|NCT01018511|182947414|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|1.21||0.011|TWO_SIDED|95.0|0.7|5.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||5.5|0.7|0.011
91534807|NCT01018511|182947414|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.314|TWO_SIDED|95.0|-1.2|3.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.6|-1.2|0.314
91758309|NCT02967510|183409738|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.119|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.119
91758310|NCT02967510|183409739|SUPERIORITY||LS Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.031|-0.444|||ANCOVA|||||-0.444|-1.031|<0.001
91534808|NCT01018511|182947414|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.19||0.003|TWO_SIDED|95.0|1.2|5.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.9|1.2|0.003
91534809|NCT01018511|182947414|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.21||0.161|TWO_SIDED|95.0|-0.7|4.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.1|-0.7|0.161
91534810|NCT01018511|182947414|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|1.21||0.708|TWO_SIDED|95.0|-1.9|2.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.8|-1.9|0.708
91534811|NCT01018511|182947415|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.83||0.043|TWO_SIDED|95.0|0.1|3.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.3|0.1|0.043
91534812|NCT01018511|182947415|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.84||0.12|TWO_SIDED|95.0|-0.3|3.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.0|-0.3|0.120
91534813|NCT01018511|182947415|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.82||0.003|TWO_SIDED|95.0|0.8|4.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.0|0.8|0.003
91534814|NCT01018511|182947415|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.83||0.014|TWO_SIDED|95.0|0.4|3.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||3.7|0.4|0.014
91534815|NCT01018511|182947415|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.83||0.384|TWO_SIDED|95.0|-0.9|2.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.4|-0.9|0.384
91534816|NCT01018511|182947416|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|0.8|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.4|0.8|0.004
91758311|NCT02967510|183409739|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.051|-0.458|||ANCOVA|||||-0.458|-1.051|<0.001
91758312|NCT02967510|183409739|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.951|-0.369|||ANCOVA|||||-0.369|-0.951|<0.001
91758313|NCT02967510|183409740|SUPERIORITY||LS Mean Difference|0.21|||<|0.001|TWO_SIDED|95.0|0.147|0.278|||ANCOVA|||||0.278|0.147|<0.001
91534817|NCT01018511|182947416|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.93||0.035|TWO_SIDED|95.0|0.1|3.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.8|0.1|0.035
91534818|NCT01018511|182947416|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|2.2|5.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.8|2.2|< 0.001
91512335|NCT00406029|182896059|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.592|TWO_SIDED|95.0|-0.6|1.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.6|0.592
91512336|NCT02832674|182896092|SUPERIORITY|||||||0.05|TWO_SIDED|90.0|||||Fisher Exact|||The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.||||0.05
91512337|NCT02832674|182896093|OTHER|Binomial test of proportions||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
91512338|NCT02832674|182896094|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared|||Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.|The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
91512339|NCT02832674|182896095|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
91512340|NCT02832674|182896096|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
91512341|NCT02832674|182896097|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
91512342|NCT00718042|182896098|SUPERIORITY_OR_OTHER||Specificity|99.86|||||TWO_SIDED|95.0|99.79|99.91|||Point Estimate||Numerator = All blood donors tested nonreactive from all True Negative blood donors (16,223) Denominator = All True Negative blood donors (16,246) True Negative excludes donor specimens positive by supplemental testing (3)|||99.91|99.79|
91534819|NCT01018511|182947416|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.5|5.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.1|1.5|< 0.001
91758314|NCT02967510|183409740|SUPERIORITY||LS Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.078|0.213|||ANCOVA|||||0.213|0.078|<0.001
91758315|NCT02967510|183409740|SUPERIORITY||LS Mean Difference|0.16|||<|0.001|TWO_SIDED|95.0|0.097|0.226|||ANCOVA|||||0.226|0.097|<0.001
91512343|NCT00718042|182896100|SUPERIORITY_OR_OTHER||Point estimate|100.0|||||TWO_SIDED|95.0|96.7|100.0|||Sensitivity|||||100.00|96.70|
91512344|NCT00718042|182896103|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|97.4|99.8|||Percentage Negative|||||99.8|97.4|
91512345|NCT02822794|182896107|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.||||||<0.001
91512346|NCT02822794|182896107|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.||||||<0.001
91512347|NCT04788147|182896136|OTHER|"The modified 3+3 design with 6 patients at the 'Recommended RefleXion FDG Dose level' aims to ensure that the observed proportion of patients below activity threshold to be less than 33%.~Probability of Observations at Most 1 of 6 below Activity Threshold True below activity rate 40% 30% 20% 10% Probability at most 1 of 6 patients below activity threshold 0.233 0.420 0.655 0.886"||||||||||||||||"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|||
91512348|NCT05101252|182896148|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.00 logMAR for distance.|Least-square Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.14|-0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 22 subjects were required to test for superiority for distance.||-0.01|-0.14|
91512349|NCT05101252|182896148|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for intermediate.|Least-square Mean|0.0|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.06|0.07|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate.||0.07|-0.06|
91512350|NCT05101252|182896148|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for near.|Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|98.75|0.02|0.16|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near.||0.16|0.02|
91512351|NCT05101252|182896149|SUPERIORITY|Superiority was declared if the lower bound of the 98.75% confidence interval was above 32.|Least-square Mean|50.8|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|98.75|43.1|58.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 99% statistical power, that 13 subjects were required to test for superiority for CLUE vision scores.||58.5|43.1|
91512352|NCT05101252|182896150|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the least-square mean difference was below 0.05 logMAR.|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.05|0.05|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Test minus Control|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 95% statistical power, that 60 subjects were required to test for non-inferiority of the Test compared to the Control for distance (4m).||0.05|-0.05|
91512353|NCT01504438|182896155|OTHER|||||||0.29|||||||ANOVA|||||||0.29
91512354|NCT01504438|182896156|OTHER|||||||0.31|||||||ANOVA|||||||0.31
91512355|NCT01504438|182896157|OTHER|||||||0.07|||||||ANOVA|||||||0.07
91512356|NCT01504438|182896158|OTHER|||||||0.04|||||||ANOVA|||||||0.04
91512357|NCT03282955|182896178|NON_INFERIORITY|Non-inferiority margin= 1.151||||||0.025|||||||t-test, 1 sided|||||||0.025
91512358|NCT02138214|182896210|OTHER|||||||0.567||||||p-value threshold for statistical significance is 0.05|Fisher Exact|||||||0.567
91512359|NCT02138214|182896211|OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.110
91512360|NCT02138214|182896213|OTHER|||||||0.758|||||||Fisher Exact|||||||0.758
91512361|NCT02138214|182896215|OTHER|||||||0.236|||||||Fisher Exact|||||||0.236
91512362|NCT02138214|182896216|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
91512363|NCT02138214|182896217|OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.400
91512364|NCT03221257|182896228|SUPERIORITY||Mean Difference (Net)|-0.14||||0.9326|TWO_SIDED||||||Mixed Models Analysis|||||||0.9326
91512365|NCT03221257|182896229|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9968|TWO_SIDED||||||Mixed Models Analysis|||||||0.9968
91512366|NCT03221257|182896230|SUPERIORITY||Mean Difference (Net)|0.46||||0.7489|TWO_SIDED||||||Mixed Models Analysis|||||||0.7489
91512367|NCT03221257|182896231|SUPERIORITY||Mean Difference (Net)|-9.2||||0.8898|TWO_SIDED||||||Mixed Models Analysis|||||||0.8898
91512368|NCT03221257|182896232|SUPERIORITY||Mean Difference (Net)|0.86||||0.3826|TWO_SIDED||||||Mixed Models Analysis|||||||0.3826
91512369|NCT03221257|182896233|SUPERIORITY||Mean Difference (Net)|-0.14||||0.2819|TWO_SIDED||||||Mixed Models Analysis|||||||0.2819
91512370|NCT03221257|182896234|SUPERIORITY||Mean Difference (Net)|-1.35||||0.7534|TWO_SIDED||||||Mixed Models Analysis|||||||0.7534
91512371|NCT03221257|182896235|SUPERIORITY||Mean Difference (Net)|-1.58||||0.1701|TWO_SIDED||||||ANCOVA|||||||0.1701
91512372|NCT03221257|182896236|SUPERIORITY||Mean Difference (Net)|-2.44||||0.3515|TWO_SIDED||||||ANCOVA|||||||0.3515
91512373|NCT03221257|182896237|SUPERIORITY||Mean Difference (Net)|-3.51||||0.1177|TWO_SIDED||||||ANCOVA|||||||0.1177
91512374|NCT03221257|182896238|SUPERIORITY||Mean Difference (Net)|-3.98||||0.1931|TWO_SIDED||||||ANCOVA|||||||0.1931
91512375|NCT03221257|182896239|SUPERIORITY||Mean Difference (Net)|121.3||||0.1811|TWO_SIDED||||||ANCOVA|||||||0.1811
91512376|NCT03221257|182896240|SUPERIORITY||Hazard Ratio (HR)|1.433||||0.3261|TWO_SIDED||||||Stratified log rank|||||||0.3261
91758316|NCT02967510|183409741|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.603|-0.4|||ANCOVA|||||-0.4|-0.603|<0.001
91758317|NCT02967510|183409741|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.572|-0.365|||ANCOVA|||||-0.365|-0.572|<0.001
91758318|NCT02967510|183409741|SUPERIORITY||LS Mean Difference|-0.43|||<|0.001|TWO_SIDED|95.0|-0.531|-0.331|||ANCOVA|||||-0.331|-0.531|<0.001
91758319|NCT02967510|183409742|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.47
91512377|NCT03221257|182896241|SUPERIORITY||Odds Ratio (OR)|1.6||||0.454|TWO_SIDED||||||Regression, Logistic|||||||0.454
91512378|NCT01971346|182896268|OTHER|||||||0.38||||||Type III TNF-alpha p-value=0.36. Type III IFN-alpha p-value=0.36. Interaction was not included in this model.|Regression, Linear|||A cumulative score reflecting change in PASI during the course of treatment was calculated and treated as a continuous response variable. Linear modeling was done to determine if change in PASI score was associated with the baseline TNF-alpha signal, baseline IFN-alpha signal and/or an interaction between these two signals.||||0.38
91512379|NCT01971346|182896269|OTHER|||||||0.03||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.03 Test of Hypotheses for Within subject effect of Time p-value=0.38 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.31|ANOVA|||The strength of the TNF-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if TNF-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.03
91512380|NCT01971346|182896270|OTHER|||||||0.34||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.34 Test of Hypotheses for Within subject effect of Time p-value=0.73 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.57|ANOVA|||The strength of the IFN-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if IFN-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.34
91512381|NCT02755831|182896292|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher's Exact Test||||<0.05
91512382|NCT02755831|182896293|OTHER||||||<|0.05|||||||Friedman test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<.05
91512383|NCT02755831|182896294|OTHER||||||<|0.05|||||||Friedman|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<0.05
91512384|NCT02755831|182896295|OTHER||||||<|0.05|||||||Friedman Test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences in treatment group only.||||||<0.05
91512385|NCT02755831|182896296|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|T-test used to compare mean difference in hospital costs at time of delivery.||||||<0.05
91512386|NCT01130740|182896380|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Mixed Models Analysis|||This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)||||0.158
91512387|NCT01130740|182896380|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|||This is the 12-month comparison between the 2 study groups, which is the primary study analysis.||||0.008
91512388|NCT01130740|182896381|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||Mixed Models Analysis|||This is the between-group 12-month comparison.||||0.274
91512389|NCT01130740|182896382|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||Mixed Models Analysis|||||||0.177
91512390|NCT01181895|182896391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.244|TWO_SIDED|95.0|-0.048|0.188||P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.|||0.188|-0.048|0.244
91512391|NCT01181895|182896391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.926|TWO_SIDED|95.0|-0.124|0.113||P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.|||0.113|-0.124|0.926
91512392|NCT04419493|182896426|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|102.2|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.87|110.1|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.10|94.87|
91512393|NCT04419493|182896428|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|105.81|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|92.83|99.18|112.88|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||112.88|99.18|
91534820|NCT01018511|182947416|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.92||0.142|TWO_SIDED|95.0|-0.5|3.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.2|-0.5|0.142
91534821|NCT01018511|182947417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.874|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.874
91534822|NCT01018511|182947417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.240
91534823|NCT01018511|182947417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.324|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.324
91534824|NCT01018511|182947417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.043
91758320|NCT02967510|183409742|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.448|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|0|-1|=0.448
91534825|NCT01018511|182947417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.407
91534826|NCT01018511|182947424|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
91534827|NCT01018511|182947424|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
91534828|NCT01018511|182947424|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
91534829|NCT01018511|182947424|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
91534830|NCT01018511|182947424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.058
91534831|NCT01018511|182947425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.053
91534832|NCT01018511|182947425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.031
91534833|NCT01018511|182947425|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
91534834|NCT01018511|182947425|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
91534835|NCT01018511|182947425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.018
91534836|NCT01018511|182947426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.110
91534837|NCT01018511|182947426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.071
91534838|NCT01018511|182947426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
91534839|NCT01018511|182947426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
91534840|NCT01018511|182947426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.019
91534841|NCT01324882|182947485|OTHER|||||||1|||||||Fisher Exact|||||||1.00
91534842|NCT00430677|182947534|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||0.746|TWO_SIDED|95.0|0.6|2.03||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.03|0.60|0.746
91534843|NCT00430677|182947534|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.6||||0.118|TWO_SIDED|95.0|0.89|2.83||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.83|0.89|0.118
91534844|NCT00430677|182947537|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.78|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.78|0.91|
91534845|NCT00430677|182947537|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.77|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.77|0.91|
91534846|NCT00430677|182947543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.68|21.3||||||||21.3|0.68|
91534847|NCT00430677|182947543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.49|1.59||||||||1.59|0.49|
91534848|NCT00430677|182947545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.19|-0.13|
91758321|NCT02967510|183409742|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.451|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.451
91758322|NCT02967510|183409743|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.329|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.329
91758323|NCT02967510|183409743|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.348|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.348
91512394|NCT04419493|182896430|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00% .|Geometric Least Squares Mean ratio (%)|102.17|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.79|110.12|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.12|94.79|
91512395|NCT03794089|182896435|SUPERIORITY|||||||0.035||||||a priori threshold for statistical significance was p\<=.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline GAD-7 total scores||||0.035
91512396|NCT03794089|182896436|SUPERIORITY|||||||0.231||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline PHQ-9 total scores||||0.231
91512397|NCT03794089|182896437|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.393||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks||||0.393
91512398|NCT03794089|182896437|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks||||0.022
91512399|NCT03794089|182896437|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.013||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks||||0.013
91512400|NCT03794089|182896437|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.049||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)||||0.049
91512401|NCT03794089|182896438|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 4 weeks||||0.008
91512402|NCT03794089|182896438|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 8 weeks||||<0.001
91512403|NCT03794089|182896438|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 12 weeks||||<0.001
91512404|NCT03794089|182896438|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)||||0.008
91512405|NCT03794089|182896439|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.44||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 4 weeks||||0.440
91512406|NCT03794089|182896439|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 8 weeks||||0.022
91512407|NCT03794089|182896439|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 12 weeks||||0.032
91512408|NCT03794089|182896439|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.091||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)||||0.091
91512409|NCT03794089|182896440|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.058||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 4 weeks||||0.058
91534849|NCT00430677|182947545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.14|-0.18|
91534850|NCT00299702|182947658|SUPERIORITY_OR_OTHER|||||||0.684||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Log Rank|Insufficient number of subjects who had an event for median estimation.||Null hypothesis: there is no difference in time to relapse||||0.684
91534851|NCT00299702|182947659|SUPERIORITY_OR_OTHER|||||||0.646||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in time in remission between the two treatment groups||||0.646
91534852|NCT02931396|182947660|SUPERIORITY||Mean Difference (Net)|2.3||||0.768|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.768
91534853|NCT02931396|182947661|SUPERIORITY||Mean Difference (Net)|25.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
91534854|NCT02931396|182947662|SUPERIORITY||Mean Difference (Net)|2.7||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
91534855|NCT01866917|182947670|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||.574
91534856|NCT01866917|182947671|SUPERIORITY|Statistical analysis performed using SPSS software, version 15 (SPSS Inc., Chicago, IL). Data for quantitative variables reported as a median and interquartile range. The Mann Whitney and chi-square tests were used for the analysis of continuous and categorical variables.|Interquartile range (IQR)|3.0||||0.825|TWO_SIDED|||||Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.|Chi-squared|||TAP has been demonstrated to have a potential role in reducing pain, post-operative opioid requirement, and time to hospital discharge after abdominal hysterectomies and cesarean sections.||||.825
91758324|NCT02967510|183409743|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
91758325|NCT02967510|183409744|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.122|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.122
91758326|NCT02967510|183409744|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.188|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.188
91758327|NCT02967510|183409744|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.222|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.222
91758328|NCT02967510|183409745|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.393|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.393
91758329|NCT02967510|183409745|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.221|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.221
91758330|NCT02967510|183409745|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.432|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.432
91758331|NCT02967510|183409746|SUPERIORITY||LS Mean Difference|0.24|||=|0.65|TWO_SIDED|95.0|-1.0|1.487|||ANCOVA|||||1.487|-1|=0.65
91758332|NCT02967510|183409746|SUPERIORITY||LS Mean Difference|-0.24|||=|0.361|TWO_SIDED|95.0|-1.568|1.09|||ANCOVA|||||1.09|-1.568|=0.361
91534857|NCT00662909|182947684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.026|TWO_SIDED|95.0|-0.66|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.03|-0.66|0.026
91534858|NCT00662909|182947684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.82|-0.18||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.18|-0.82|<0.001
91534859|NCT00662909|182947685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.98|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.98|0.001
91758333|NCT02967510|183409746|SUPERIORITY||LS Mean Difference|0.03|||=|0.522|TWO_SIDED|95.0|-1.188|1.257|||ANCOVA|||||1.257|-1.188|=0.522
91534860|NCT00662909|182947685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.07|-0.33||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.33|-1.07|<0.001
91534861|NCT00662909|182947686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.1||||0.001|TWO_SIDED|95.0|4.4|17.9||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.9|4.4|0.001
91534862|NCT00662909|182947686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0||||0.002|TWO_SIDED|95.0|4.2|17.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.7|4.2|0.002
91534863|NCT00662909|182947687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48||||0.003|TWO_SIDED|95.0|-0.8|-0.15||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.15|-0.80|0.003
91534864|NCT00662909|182947687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.79|-0.13||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.13|-0.79|<0.001
91534865|NCT00662909|182947688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.022|TWO_SIDED|95.0|-0.77|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.77|0.022
91758334|NCT02967510|183409747|SUPERIORITY||LS Mean Difference|-0.56|||=|0.043|TWO_SIDED|95.0|-1.204|0.079|||ANCOVA|||||0.079|-1.204|=0.043
91758335|NCT02967510|183409747|SUPERIORITY||LS Mean Difference|-0.51|||=|0.061|TWO_SIDED|95.0|-1.158|0.137|||ANCOVA|||||0.137|-1.158|=0.061
91758336|NCT02967510|183409747|SUPERIORITY||LS Mean Difference|-0.48|||=|0.071|TWO_SIDED|95.0|-1.111|0.16|||ANCOVA|||||0.16|-1.111|=0.071
91758337|NCT02967510|183409748|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.012|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.012
91758338|NCT02967510|183409748|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.007|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.007
91534866|NCT00662909|182947688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.96|0.001
91534867|NCT00530335|182947719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91758339|NCT02967510|183409748|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
91534868|NCT00530335|182947719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534869|NCT00530335|182947719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534870|NCT00530335|182947719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534871|NCT00530335|182947720|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534872|NCT00530335|182947720|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534873|NCT00530335|182947720|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534874|NCT00530335|182947720|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534875|NCT00530335|182947721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91534876|NCT00530335|182947722|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||t-test, 2 sided|||||||0.749
91534877|NCT00530335|182947723|SUPERIORITY_OR_OTHER|||||||0.886||95.0|||||t-test, 2 sided|||||||0.886
91534878|NCT00530335|182947725|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.005
91758340|NCT02967510|183409749|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.438|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.438
91534879|NCT00530335|182947725|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||<0.001
91534880|NCT00530335|182947725|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.003
91758341|NCT02967510|183409749|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.388|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.388
91758342|NCT02967510|183409749|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
91758343|NCT02967510|183409750|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
91758344|NCT02967510|183409750|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.02|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.02
91758345|NCT02967510|183409750|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.003|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.003
91758346|NCT02967510|183409751|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.002|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.002
91534881|NCT01451814|182947795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|95.0|0.67|5.48|||Chi-squared|||||5.48|0.67|.22
91534882|NCT01451814|182947796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3||||0.06|TWO_SIDED|95.0|0.84|22.1|||Chi-squared|||||22.1|0.84|.06
91534883|NCT01451814|182947797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||0.18|TWO_SIDED|95.0|0.56|16.11|||Chi-squared|||||16.11|0.56|.18
91534884|NCT01466881|182947808|SUPERIORITY_OR_OTHER|||||||0.2316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided alpha level of 0.05||The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.||||0.2316
91534885|NCT02219490|182947813|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91534886|NCT02219490|182947813|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
91758347|NCT02967510|183409751|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.331|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.331
91758348|NCT02967510|183409751|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.043|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.043
91758349|NCT02967510|183409752|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
91758350|NCT02967510|183409752|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.032
91534887|NCT02219490|182947814|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91758351|NCT02967510|183409752|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
91759930|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.85|||||TWO_SIDED|95.0|-19.79|-5.91||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.91|-19.79|
91759931|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.92|||||TWO_SIDED|95.0|-22.79|-9.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.06|-22.79|
91512410|NCT03794089|182896440|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 8 weeks||||0.032
91512411|NCT03794089|182896440|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.007||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 12 weeks||||0.007
91512412|NCT03794089|182896440|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.044||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to Post assessment (16 weeks)||||0.044
91512413|NCT03794089|182896441|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.328||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 4 weeks||||0.328
91512414|NCT03794089|182896441|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.148||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 8 weeks||||0.148
91512415|NCT03794089|182896441|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.002||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 12 weeks||||0.002
91512416|NCT03794089|182896441|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.069||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to Post-assessment (16 weeks)||||0.069
91512417|NCT03794089|182896442|SUPERIORITY|||||||0.928||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores||||0.928
91512418|NCT03794089|182896443|SUPERIORITY|||||||0.402||||||a priori threshold for statistical significance was p\<.05|Fisher Exact|degrees of freedom = 1||Testing null hypothesis of no difference between groups||||0.402
91512419|NCT03794089|182896444|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||<0.001
91512420|NCT03794089|182896445|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|Used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||.006
91512421|NCT03794089|182896446|SUPERIORITY|||||||0.004||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||0.004
91512422|NCT03794089|182896447|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||0.002
91512423|NCT03119766|182896459|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.041|TWO_SIDED|95.0|0.04|1.85|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of GIS scores after 8 weeks of treatment were compared.||1.85|0.04|0.041
91512424|NCT03119766|182896459|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.041|TWO_SIDED|95.0|0.04|1.74|||Mixed Models Analysis||"Fixed factor Treatment and random factor research center were used in mixed model. Difference in mean changes between groups was estimeted."|Mean changes of GIS scores after 8 weeks of treatment were compared. Influence of between center variation was estimated.||1.74|0.04|0.041
91512425|NCT03119766|182896460|SUPERIORITY|||||||0.067|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 1 point.||||0.067
91512426|NCT03119766|182896460|SUPERIORITY|||||||0.029|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 2 points.||||0.029
91512427|NCT03119766|182896460|SUPERIORITY|||||||0.082|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 3 points.||||0.082
91512428|NCT03119766|182896460|SUPERIORITY|||||||0.046|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 4 points.||||0.046
91512429|NCT03119766|182896460|SUPERIORITY|||||||0.111|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 5 points.||||0.111
91512430|NCT03119766|182896461|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.435|TWO_SIDED|95.0|-0.93|2.15|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of NDI scores after 8 weeks of treatment were compared.||2.15|-0.93|0.435
91512431|NCT03119766|182896462|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.655|TWO_SIDED|95.0|-2.0|1.26|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of SF-36 scores (physical health domain) after 8 weeks of treatment were compared.||1.26|-2.00|0.655
91512432|NCT03119766|182896462|SUPERIORITY||Median Difference (Final Values)|0.65||||0.375|TWO_SIDED|95.0|-0.79|2.1|||ANOVA|||Mean changes of SF-36 scores (mental health domain) after 8 weeks of treatment were compared.||2.10|-0.79|0.375
91512433|NCT03119766|182896463|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91534888|NCT02219490|182947814|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
91534889|NCT02219490|182947815|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91534890|NCT02219490|182947815|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
91534891|NCT02219490|182947816|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
91534892|NCT02219490|182947816|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
91534893|NCT02219490|182947817|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
91534894|NCT02219490|182947817|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
91534895|NCT02219490|182947818|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
91534896|NCT02219490|182947818|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
91534897|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.7||0.151|TWO_SIDED|95.0|-0.37|2.37|||ANCOVA||Difference = with SVR12 minus without SVR12|"Final Treatment Visit~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||2.37|-0.37|0.151
91534898|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.78||0.878|TWO_SIDED|95.0|-1.64|1.4|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 12~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.4|-1.64|0.878
91534899|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.72|=|0.199|TWO_SIDED|95.0|-2.33|0.48|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 24~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.48|-2.33|=0.199
91534900|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.93||0.021|TWO_SIDED|95.0|-4.0|-0.33|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 52~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.33|-4|0.021
91758352|NCT02967510|183409753|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.176|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.176
91758353|NCT02967510|183409753|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.358|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.358
91512434|NCT03119766|182896464|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.08
91512435|NCT03119766|182896464|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect||||0.139
91512436|NCT03119766|182896464|SUPERIORITY|||||||0.251|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.251
91512437|NCT02034578|182896467|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.953|||||TWO_SIDED|90.0|0.873|1.04||||||B versus A||1.040|0.873|
91512438|NCT02034578|182896467|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.805|||||TWO_SIDED|90.0|0.749|0.865||||||C versus A||0.865|0.749|
91512439|NCT02034578|182896469|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.924|1.01||||||B versus A||1.010|0.924|
91512440|NCT02034578|182896469|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.919|||||TWO_SIDED|90.0|0.896|0.942||||||C versus A||0.942|0.896|
91758354|NCT02967510|183409753|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.21|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.21
91758355|NCT02967510|183409754|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.106|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.106
91758356|NCT02967510|183409754|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.229|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.229
91758357|NCT02967510|183409754|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.345|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.345
91758358|NCT02967510|183409755|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.026|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.026
91758359|NCT02967510|183409755|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.424|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.424
91758360|NCT02967510|183409755|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.414|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.414
91758361|NCT02967510|183409756|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.36|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.36
91758362|NCT02967510|183409756|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.12|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.12
91758363|NCT02967510|183409756|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
91758364|NCT02967510|183409757|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.47
91758365|NCT02967510|183409757|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.137|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.137
91758366|NCT02967510|183409757|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.133|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.133
91758367|NCT02967510|183409758|SUPERIORITY||LS Mean Difference|0.74|||=|0.85|TWO_SIDED|95.0|-0.669|2.153|||ANCOVA|||||2.153|-0.669|=0.85
91758368|NCT02967510|183409758|SUPERIORITY||LS Mean Difference|0.87|||=|0.877|TWO_SIDED|95.0|-0.611|2.361|||ANCOVA|||||2.361|-0.611|=0.877
91758369|NCT02967510|183409758|SUPERIORITY||LS Mean Difference|-0.64|||=|0.178|TWO_SIDED|95.0|-2.009|0.728|||ANCOVA|||||0.728|-2.009|=0.178
91758370|NCT02967510|183409759|SUPERIORITY||LS Mean Difference|-0.16|||=|0.323|TWO_SIDED|95.0|-0.854|0.531|||ANCOVA|||||0.531|-0.854|=0.323
91758371|NCT02967510|183409759|SUPERIORITY||LS Mean Difference|-0.22|||=|0.272|TWO_SIDED|95.0|-0.917|0.484|||ANCOVA|||||0.484|-0.917|=0.272
91758372|NCT02967510|183409759|SUPERIORITY||LS Mean Difference|-0.6|||=|0.043|TWO_SIDED|95.0|-1.29|0.084|||ANCOVA|||||0.084|-1.29|=0.043
91512441|NCT02034578|182896470|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.968|||||TWO_SIDED|90.0|0.926|1.011||||||B versus A||1.011|0.926|
91512442|NCT02034578|182896470|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.922|||||TWO_SIDED|90.0|0.899|0.947||||||C versus A||0.947|0.899|
91512443|NCT01782131|182896483|NON_INFERIORITY|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme. The p-Value is based on the one-sided non-inferiority test. Non-inferiority of posaconazole vs. voriconazole is established if the upper limit of the 95% confidence interval is less than 10%.|Estimated Difference in Percent|-5.3|||<|0.0001|TWO_SIDED|95.0|-11.6|1.0|||Miettinen and Nurminen|||||1.0|-11.6|<.0001
91512444|NCT01782131|182896484|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|0.3|||||TWO_SIDED|95.0|-8.2|8.8||||||||8.8|-8.2|
91512445|NCT01782131|182896485|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-2.5|||||TWO_SIDED|95.0|-9.9|4.9||||||||4.9|-9.9|
91512446|NCT01782131|182896486|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|3.1|||||TWO_SIDED|95.0|-6.9|13.1||||||||13.1|-6.9|
91512447|NCT01782131|182896487|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-3.4|||||TWO_SIDED|95.0|-13.9|7.1||||||||7.1|-13.9|
91512448|NCT01782131|182896488|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Difference in Percent|-0.6|||||TWO_SIDED|95.0|-11.2|10.1||||||||10.1|-11.2|
91512449|NCT01782131|182896489|OTHER||Survival Rate in Percent|60.7||||0.2767|TWO_SIDED|95.0|52.8|67.8||Based on Stratified Log-Rank method stratified by the risk for mortality/poor outcome (high risk, not high risk).|Kaplan-Meier|From product-limit (Kaplan-Meier) method for censored data.||Analysis of Time to All-Cause Mortality Through Day 114: Posaconazole vs. Voriconazole||67.8|52.8|0.2767
91512450|NCT01782131|182896490|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|20.4|||||TWO_SIDED|95.0|-4.1|42.7||||||||42.7|-4.1|
91512451|NCT01782131|182896491|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|11.3|||||TWO_SIDED|95.0|-6.9|28.6||||||||28.6|-6.9|
91512452|NCT01782131|182896492|OTHER||Difference in Percent|0.3||||0.8305|TWO_SIDED|95.0|-2.9|3.6|||Miettinen & Nurminen|||Abnormal Hepatic Laboratory Value||3.6|-2.9|0.8305
91512453|NCT01782131|182896492|OTHER||Difference in Percent|-3.6||||0.3633|TWO_SIDED|95.0|-11.3|4.2|||Miettinen & Nurminen|||CNS and Visual Disturbances||4.2|-11.3|0.3633
91512454|NCT01782131|182896492|OTHER||Difference in Percent|-2.8||||0.3724|TWO_SIDED|95.0|-9.1|3.4|||Miettinen & Nurminen|||Dermatologic Reactions||3.4|-9.1|0.3724
91512455|NCT01782131|182896492|OTHER||Difference in Percent|1.0||||0.6431|TWO_SIDED|95.0|-3.4|5.5|||Miettinen & Nurminen|||Adrenal Insufficiency or Temporal Hypotension||5.5|-3.4|0.6431
91512456|NCT01782131|182896493|OTHER|Based on Miettinen \& Nurminen|Difference in Percent|0.0|||||TWO_SIDED|95.0|-2.8|2.8||||||||2.8|-2.8|
91512457|NCT01782131|182896494|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-10.2|||||TWO_SIDED|95.0|-17.9|-2.4||||||||-2.4|-17.9|
91512458|NCT01782131|182896495|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|1.9|||||TWO_SIDED|95.0|-6.1|9.8||||||||9.8|-6.1|
91512459|NCT01782131|182896496|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-1.4|||||TWO_SIDED|95.0|-5.6|2.7||||||||2.7|-5.6|
91512460|NCT01782131|182896497|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-3.2|||||TWO_SIDED|95.0|-11.0|4.5||||||||4.5|-11.0|
91512461|NCT01627249|182896499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.4|5.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||5.7|1.4|<0.001
91512462|NCT01627249|182896499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.034|TWO_SIDED|95.0|0.1|4.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||4.2|0.1|0.034
91512463|NCT01627249|182896499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.12|TWO_SIDED|95.0|-0.4|3.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs. Bevacizumab||3.2|-0.4|0.12
91512464|NCT01627249|182896500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.9|||<|0.001|TWO_SIDED|95.0|-91.1|-48.6|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||-48.6|-91.1|<0.001
91534901|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.89||0.006|TWO_SIDED|95.0|-4.22|-0.71|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 104~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.71|-4.22|0.006
91534902|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-2.58|STANDARD_ERROR_OF_MEAN|0.92||0.005|TWO_SIDED|95.0|-4.38|-0.79|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 156~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.79|-4.38|0.005
91534903|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.0||0.172|TWO_SIDED|95.0|-3.32|0.59|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 208~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.59|-3.32|0.172
91534904|NCT02219490|182947819|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.14||0.322|TWO_SIDED|95.0|-3.35|1.1|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 260~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.1|-3.35|0.322
91534905|NCT01454362|182947821|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91534906|NCT01454362|182947822|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
91534907|NCT01454362|182947823|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91534908|NCT01454362|182947824|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91534909|NCT01454362|182947825|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91534910|NCT01928940|182947848|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
91534911|NCT01928940|182947848|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
91534912|NCT01928940|182947853|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
91534913|NCT01928940|182947853|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|82.2|||Exact binomial test||BICR Assessed ORR|||82.2|11.8|0.0158
91758373|NCT02967510|183409760|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.009|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.009
91534914|NCT01928940|182947854|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
91534915|NCT01928940|182947854|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|88.2|||Exact binomial test||BICR Assessed ORR|||88.2|11.8|0.0158
91534916|NCT01928940|182947857|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
91534917|NCT01928940|182947857|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
91534918|NCT01363479|182947872|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.|Risk Difference (RD)|3.21|||||TWO_SIDED|99.0|-2.74|9.17|||||The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.|||9.17|-2.74|
91534919|NCT04807517|182947906|OTHER|Within-group test for 16-week change|||||<|0.001|||||||Regression, Linear|Repeated measures linear regression||||||<0.001
91534920|NCT04939428|182947932|SUPERIORITY||Confidence Interval|-2.0|||=|0.0848|TWO_SIDED|95.0|-5.0|0.9|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.9|-5|= 0.0848
91534921|NCT04939428|182947933|OTHER|Estimated differences and confidence intervals are provided.|Confidence Interval|-1.4|||||TWO_SIDED|95.0|-4.8|2.0|||Miettinen & Nurminen method|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||2.0|-4.8|
91534922|NCT04939428|182947934|OTHER|Estimated differences and confidence intervals are provided|Confidence Interval|0.3|||||TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen method.|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||1.0|-0.4|
91534923|NCT04939428|182947935|SUPERIORITY||Confidence Interval|-3.2|||=|0.0205|TWO_SIDED|95.0|-6.3|-0.1|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||-0.1|-6.3|= 0.0205
91534924|NCT04939428|182947936|OTHER|Adjusted differences and the corresponding confidence intervals.|Confidence Interval|-2.2|||||TWO_SIDED|95.0|-5.4|1.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||1.0|-5.4|
91534925|NCT04939428|182947937|OTHER|Adjusted differences and the corresponding confidence intervals|Confidence Interval|-3.0|||||TWO_SIDED|95.0|-6.9|0.8||||||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.8|-6.9|
91534926|NCT04939428|182947938|OTHER|Adjusted differences and the corresponding confidence intervals.|Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-22.7|2.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||2.0|-22.7|
91534927|NCT05096117|182947939|SUPERIORITY||Least Square Mean Difference|0.178||||0.784|TWO_SIDED||||||ANCOVA|||||||0.784
91534928|NCT04319094|182947953|SUPERIORITY||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.77|-2.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.62|-4.77|<0.0001
91534929|NCT04319094|182947953|SUPERIORITY||Mean Difference (Net)|-2.53|STANDARD_ERROR_OF_MEAN|0.65||0.0001|TWO_SIDED|95.0|-3.81|-1.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.25|-3.81|0.0001
91534930|NCT04319094|182947953|SUPERIORITY||Median Difference (Net)|-2.83|STANDARD_ERROR_OF_MEAN|0.66|<|0.0001|TWO_SIDED|95.0|-4.13|-1.53||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 6-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.53|-4.13|<0.0001
91534931|NCT04319094|182947953|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.65|<|0.0001|TWO_SIDED|95.0|-4.03|-1.49||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 9-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.49|-4.03|<0.0001
91534932|NCT04319094|182947953|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|0.71||0.0003|TWO_SIDED|95.0|-3.95|-1.17||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference =12-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.17|-3.95|0.0003
91534933|NCT04319094|182947953|SUPERIORITY|||||||0.4375|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of PHQ-9 over time between the control and PEERS participants.||||0.4375
91534934|NCT04319094|182947954|SUPERIORITY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|2.42||0.51|TWO_SIDED|95.0|-3.15|6.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36 - Physical Functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.37|-3.15|0.51
91758374|NCT02967510|183409760|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.025|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.025
91759932|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.95|||||TWO_SIDED|95.0|-10.89|2.99||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.99|-10.89|
91758375|NCT02967510|183409760|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
91758376|NCT02967510|183409761|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.04|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.04
91758377|NCT02967510|183409761|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
91758378|NCT02967510|183409761|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.104|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.104
91758379|NCT02967510|183409762|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
91758380|NCT02967510|183409762|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
91758381|NCT02967510|183409762|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
91758382|NCT02967510|183409763|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
91758383|NCT02967510|183409763|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.054|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.054
91758384|NCT02967510|183409763|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|<0.001
91758385|NCT02967510|183409764|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.008|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.008
91758386|NCT02967510|183409764|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.01|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.01
91758387|NCT02967510|183409764|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
91758388|NCT02967510|183409765|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.071|-0.548|||ANCOVA|||||-0.548|-1.071|<0.001
91758389|NCT02967510|183409765|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.013|-0.484|||ANCOVA|||||-0.484|-1.013|<0.001
91758390|NCT02967510|183409765|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.916|-0.397|||ANCOVA|||||-0.397|-0.916|<0.001
91758391|NCT02967510|183409766|SUPERIORITY||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.337|0.535|||ANCOVA|||||0.535|0.337|<0.001
91758392|NCT02967510|183409766|SUPERIORITY||LS Mean Difference|0.39|||<|0.001|TWO_SIDED|95.0|0.291|0.494|||ANCOVA|||||0.494|0.291|<0.001
91758393|NCT02967510|183409766|SUPERIORITY||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.245|0.439|||ANCOVA|||||0.439|0.245|<0.001
91534935|NCT04319094|182947954|SUPERIORITY||Mean Difference (Net)|4.57||||0.18|TWO_SIDED|95.0|-2.08|11.21||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.21|-2.08|0.18
91534936|NCT04319094|182947954|SUPERIORITY||Mean Difference (Net)|1.57|STANDARD_ERROR_OF_MEAN|3.29||0.63|TWO_SIDED|95.0|-4.89|8.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.04|-4.89|0.63
91534937|NCT04319094|182947954|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.01||0.74|TWO_SIDED|95.0|-6.94|4.91||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.91|-6.94|0.74
91534938|NCT04319094|182947954|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.83||0.85|TWO_SIDED|95.0|-6.82|8.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.23|-6.82|0.85
91534939|NCT04319094|182947954|SUPERIORITY|||||||0.3988|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants.||||0.3988
91534940|NCT04319094|182947955|SUPERIORITY||Mean Difference (Net)|5.08|STANDARD_ERROR_OF_MEAN|3.41||0.14|TWO_SIDED|95.0|-1.63|11.79||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.79|-1.63|0.14
91534941|NCT04319094|182947955|SUPERIORITY||Mean Difference (Net)|10.32|STANDARD_ERROR_OF_MEAN|4.0||0.01|TWO_SIDED|95.0|2.45|18.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.19|2.45|0.01
91534942|NCT04319094|182947955|SUPERIORITY||Mean Difference (Net)|10.25|STANDARD_ERROR_OF_MEAN|4.19||0.015|TWO_SIDED|95.0|2.01|18.5||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.5|2.01|0.015
91758394|NCT02967510|183409767|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.575|-0.371|||ANCOVA|||||-0.371|-0.575|<0.001
91758395|NCT02967510|183409767|SUPERIORITY||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.592|-0.383|||ANCOVA|||||-0.383|-0.592|<0.001
91758396|NCT02967510|183409767|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA|||||-0.3|-0.5|<0.001
91758397|NCT00787189|183409779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Fisher Exact|||||||<0.0005
91758398|NCT02227394|183409841|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.187||||0.727|TWO_SIDED|90.0|-1.098|0.724|||t-test, 2 sided|||||0.724|-1.098|0.727
91534943|NCT04319094|182947955|SUPERIORITY||Mean Difference (Net)|11.72|STANDARD_ERROR_OF_MEAN|4.07||0.004|TWO_SIDED|95.0|3.7|19.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|19.73|3.7|0.004
91534944|NCT04319094|182947955|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|4.49||0.2|TWO_SIDED|95.0|-3.09|14.55||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|14.55|-3.09|0.2
91534945|NCT04319094|182947955|SUPERIORITY|||||||0.8037|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants.||||0.8037
91534946|NCT04319094|182947956|SUPERIORITY||Median Difference (Net)|12.52|STANDARD_ERROR_OF_MEAN|5.01||0.0129|TWO_SIDED|95.0|2.67|22.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|22.37|2.67|0.0129
91534947|NCT04319094|182947956|SUPERIORITY||Mean Difference (Net)|19.84|STANDARD_ERROR_OF_MEAN|5.86||0.0008|TWO_SIDED|95.0|8.32|31.36||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|31.36|8.32|0.0008
91534948|NCT04319094|182947956|SUPERIORITY||Median Difference (Net)|17.99|STANDARD_ERROR_OF_MEAN|6.14||0.0036|TWO_SIDED|95.0|5.92|30.06||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|30.06|5.92|0.0036
91534949|NCT04319094|182947956|SUPERIORITY||Median Difference (Net)|16.24|STANDARD_ERROR_OF_MEAN|5.98||0.007|TWO_SIDED|95.0|4.47|28.01||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|28.01|4.47|0.007
91534950|NCT04319094|182947956|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|6.58||0.065|TWO_SIDED|95.0|-0.68|25.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|25.19|-0.68|0.065
91534951|NCT04319094|182947956|SUPERIORITY|||||||0.881|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants.||||0.8810
91535623|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.01|STANDARD_ERROR_OF_MEAN|2.41||0.0395|TWO_SIDED|95.0|-9.78|-0.24||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.24|-9.78|0.0395
91758399|NCT02227394|183409842|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.003||||0.366|TWO_SIDED|90.0|-0.002|0.007|||t-test, 2 sided|||||0.007|-0.002|0.366
91534952|NCT04319094|182947957|SUPERIORITY|||||||0.031||||||The a priori threshold for statistical significance is p=0.05.|F-test for overall significance|Degrees of freedom: 370||Null hypothesis: there is no difference in the change in probability of ER use from baseline to post-intervention between PEERS and control participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|||0.031
91534953|NCT04319094|182947962|SUPERIORITY||Mean Difference (Net)|-4.98|STANDARD_ERROR_OF_MEAN|1.42||0.0005|TWO_SIDED|95.0|-7.78|-2.18||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.18|-7.78|0.0005
91534954|NCT04319094|182947962|SUPERIORITY||Mean Difference (Net)|-7.38|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.08|-3.69||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.69|-11.08|<0.0001
91534955|NCT04319094|182947962|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-11.3|-3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.95|-11.3|<0.0001
91534956|NCT04319094|182947962|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-11.53|-4.7||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.7|-11.53|<0.0001
91534957|NCT04319094|182947962|SUPERIORITY||Mean Difference (Net)|-8.26|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-12.37|-4.14||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.14|-12.37|<0.0001
91534958|NCT04319094|182947962|SUPERIORITY|||||||0.6857|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participants||||0.6857
91758400|NCT02227394|183409844|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.025||||0.486|TWO_SIDED|90.0|-0.035|0.084|||t-test, 2 sided|||||0.084|-0.035|0.486
91758401|NCT02227394|183409845|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.049||||0.413|TWO_SIDED|90.0|-0.052|0.15|||t-test, 2 sided|||||0.150|-0.052|0.413
91758402|NCT02227394|183409846|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.1||||0.375|TWO_SIDED|90.0|-0.289|0.09|||t-test, 2 sided|||||0.090|-0.289|0.375
91512465|NCT01627249|182896500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.6||||0.036|TWO_SIDED|95.0|-36.0|-1.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||-1.2|-36|0.036
91512466|NCT01627249|182896500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.2|||<|0.001|TWO_SIDED|95.0|-71.2|-31.3|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||-31.3|-71.2|<0.001
91512467|NCT01627249|182896501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.001|TWO_SIDED|95.0|2.9|10.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||10.1|2.9|0.001
91512468|NCT01627249|182896501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.0031|TWO_SIDED|95.0|1.4|8.0|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||8.0|1.4|0.0031
91512469|NCT01627249|182896501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.21|TWO_SIDED|95.0|-1.1|4.8|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||4.8|-1.1|0.21
91512470|NCT01627249|182896502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.69|TWO_SIDED|95.0|-1.3|2.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||2.7|-1.3|0.69
91512471|NCT01627249|182896502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||1.5|-2.3|0.69
91512472|NCT01627249|182896502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.69|TWO_SIDED|95.0|-0.9|3.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||3.1|-0.9|0.69
91512473|NCT01176591|182896517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91512474|NCT01176591|182896518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91512475|NCT01176591|182896519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91512476|NCT01176591|182896520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||t-test, 2 sided|||||||0.039
91512477|NCT01176591|182896522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91512478|NCT01073618|182896523|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|75.15|||||TWO_SIDED|95.0|71.36|78.94|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||78.94|71.36|
91512479|NCT02039505|182896544|SUPERIORITY||Adjusted Odds Ratio|1.37||||0.2722|TWO_SIDED|95.0|0.779|2.399|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||2.399|0.779|0.2722
91512480|NCT02039505|182896545|SUPERIORITY||Adjusted Odds Ratio|2.88||||0.021|TWO_SIDED|95.0|1.168|7.108|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||7.108|1.168|0.0210
91512481|NCT02039505|182896551|SUPERIORITY||Adjusted Odds Ratio|1.66||||0.198|TWO_SIDED|95.0|0.762|3.596|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||3.596|0.762|0.1980
91512482|NCT02039505|182896552|SUPERIORITY||Adjusted Odds Ratio|1.33||||0.3168|TWO_SIDED|95.0|0.755|2.356|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||2.356|0.755|0.3168
91512483|NCT02039505|182896553|SUPERIORITY||Adjusted Odds Ratio|3.48||||0.0067|TWO_SIDED|95.0|1.407|8.626|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.626|1.407|0.0067
91512484|NCT02039505|182896554|SUPERIORITY||Adjusted Odds Ratio|3.49||||0.0066|TWO_SIDED|95.0|1.409|8.642|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.642|1.409|0.0066
91512485|NCT02039505|182896555|SUPERIORITY||Adjusted Odds Ratio|2.02||||0.209|TWO_SIDED|95.0|0.677|6.033|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||6.033|0.677|0.2090
91512486|NCT02039505|182896556|SUPERIORITY||Adjusted Odds Ratio|3.38||||0.1571|TWO_SIDED|95.0|0.636|17.981|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||17.981|0.636|0.1571
91512487|NCT04088097|182896563|SUPERIORITY|||||||0.01|||||||ANOVA|||||||.01
91512488|NCT04088097|182896564|SUPERIORITY|||||||0.75|||||||ANOVA|||||||.75
91512489|NCT04088097|182896565|SUPERIORITY|||||||0.03|||||||ANOVA|||||||.03
91512490|NCT03556761|182896567|SUPERIORITY||Risk Ratio (RR)|0.4||||0.03|TWO_SIDED|95.0|0.2|0.81|||Regression, Linear|||||0.81|0.20|0.03
91512491|NCT03556761|182896568|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.12|TWO_SIDED|95.0|0.95|1.51|||Regression, Cox|||||1.51|0.95|0.12
91512492|NCT03556761|182896569|SUPERIORITY||Risk Ratio (RR)|0.55||||0.14|TWO_SIDED|95.0|0.25|1.21|||Chi-squared|||||1.21|0.25|0.14
91512493|NCT03556761|182896570|SUPERIORITY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.64|1.18|||Chi-squared|||||1.18|0.64|0.36
91512494|NCT03556761|182896571|SUPERIORITY||Risk Ratio (RR)|0.02||||0.76|TWO_SIDED|95.0|-0.09|0.13|||Regression, Linear|||||.13|-0.09|0.76
91512495|NCT03556761|182896572|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
91512496|NCT03556761|182896573|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.32|28.59||||||||28.59|0.32|
91512497|NCT03556761|182896574|SUPERIORITY||Risk Ratio (RR)|0.61||||0.03|TWO_SIDED|95.0|0.39|0.96|||Chi-squared|||||0.96|0.39|0.03
91512498|NCT01154166|182896577|SUPERIORITY_OR_OTHER||Adjusted mean for treatment difference|-1.76|||<|0.001|TWO_SIDED|95.0|-2.27|-1.26|||ANCOVA||The estimated value indicates the treatment difference for the adjusted mean for Ropinirole PR and placebo.|||-1.26|-2.27|<0.001
91512499|NCT00491244|182896603|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8|||<|0.001|TWO_SIDED|95.0|1.46|2.21|||Chi-squared|||||2.21|1.46|< 0.001
91534959|NCT04319094|182947963|SUPERIORITY||Mean Difference (Net)|1.79|STANDARD_ERROR_OF_MEAN|0.54||0.001|TWO_SIDED|95.0|0.72|2.86|||Mixed Models Analysis|Degrees of freedom: 421|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.86|0.72|0.001
91534960|NCT04319094|182947963|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.67||0.18|TWO_SIDED|95.0|-0.39|2.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.25|-0.39|0.18
91534961|NCT04319094|182947963|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.68||0.11|TWO_SIDED|95.0|-0.24|2.45||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.45|-0.24|0.11
91534962|NCT04319094|182947963|SUPERIORITY||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|0.65||0.0006|TWO_SIDED|95.0|0.98|3.54||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.54|0.98|0.0006
91534963|NCT04319094|182947963|SUPERIORITY||Mean Difference (Net)|2.48|STANDARD_ERROR_OF_MEAN|0.75||0.001|TWO_SIDED|95.0|1.01|3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.95|1.01|0.001
91534964|NCT04319094|182947963|SUPERIORITY|||||||0.1195|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants.||||0.1195
91534965|NCT04319094|182947964|SUPERIORITY||Mean Difference (Net)|3.22|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|1.71|4.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.73|1.71|<0.0001
91512500|NCT00491244|182896604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.61||||0.35|TWO_SIDED|95.0|0.65|4.01|||Chi-squared|||||4.01|0.65|0.35
91534966|NCT04319094|182947964|SUPERIORITY||Mean Difference (Net)|2.59|STANDARD_ERROR_OF_MEAN|1.03||0.0123|TWO_SIDED|95.0|0.57|4.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.62|0.57|0.0123
91512501|NCT01276327|182896605|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.11|102.81|||Unscaled average Bioequivalence||Geometric standard error of mean was calculated.|||102.81|97.11|
91758403|NCT02227394|183409847|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.009||||0.879|TWO_SIDED|90.0|-0.092|0.11|||t-test, 2 sided|||||0.110|-0.092|0.879
91758404|NCT02227394|183409848|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.023||||0.819|TWO_SIDED|90.0|-0.149|0.195|||t-test, 2 sided|||||0.195|-0.149|0.819
91758405|NCT02227394|183409849|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.4||||0.643|TWO_SIDED|90.0|-1.87|1.07|||t-test, 2 sided|||||1.070|-1.870|0.643
91758406|NCT02227394|183409850|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.011||||0.866|TWO_SIDED|90.0|-0.1|0.122|||t-test, 2 sided|||||0.122|-0.100|0.866
91758407|NCT02227394|183409851|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.054||||0.346|TWO_SIDED|90.0|-0.043|0.152|||t-test, 2 sided|||||0.152|-0.043|0.346
91758408|NCT02227394|183409852|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.029||||0.093|TWO_SIDED|90.0|0.001|0.058|||t-test, 2 sided|||||0.058|0.001|0.093
91758409|NCT02227394|183409853|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.074||||0.686|TWO_SIDED|90.0|-0.386|0.238|||t-test, 2 sided|||||0.238|-0.386|0.686
91758410|NCT02227394|183409855|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-10.368||||0.312|TWO_SIDED|90.0|-27.659|6.922|||t-test, 2 sided|||||6.922|-27.659|0.312
91758411|NCT02227394|183409856|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.02||||0.92|TWO_SIDED|90.0|-0.361|0.321|||t-test, 2 sided|||||0.321|-0.361|0.920
91758412|NCT02227394|183409857|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.08||||0.818|TWO_SIDED|90.0|-0.513|0.673|||t-test, 2 sided|||||0.673|-0.513|0.818
91512502|NCT01276327|182896606|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|94.17|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|89.08|99.55|||Unscaled average Bioequivalence||Geometric Standard error of mean was calculated.|||99.55|89.08|
91512503|NCT01276327|182896607|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.|Adjusted gMean Ratio (Test/Ref) (%)|79.99|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|74.65|85.72|||Scaled average bioequivalence (SABE)||Geometric Standard error of mean was calculated.|||85.72|74.65|
91512504|NCT01276327|182896608|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|97.31|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|88.9|106.51|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||106.51|88.90|
91512505|NCT01276327|182896609|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.1|102.81|||Unscaled average bioequivalence||Geometric Standard error of mean was calculated.|||102.81|97.10|
91512506|NCT01276327|182896610|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|101.85|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|98.18|105.67|||Unscaled average bioequivalence||Geometric standard error of mean was calculated.|||105.67|98.18|
91512507|NCT01276327|182896611|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|80.79|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|75.6|86.34|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||86.34|75.60|
91512508|NCT00807092|182896614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.666||||95.0|-1.332|1.306||A statistical significant threshold p less than 0.025|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean IAUC(0-4hours) as covariate|BIAsp 30 - BHI 30|"The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol\*h/L"||1.306|-1.332|
91534967|NCT04319094|182947964|SUPERIORITY||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|1.02||0.01|TWO_SIDED|95.0|0.63|4.63||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.63|0.63|0.01
91534968|NCT04319094|182947964|SUPERIORITY||Mean Difference (Net)|4.18|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|2.32|6.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.04|2.32|<0.0001
91534969|NCT04319094|182947964|SUPERIORITY||Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.17||0.0078|TWO_SIDED|95.0|0.83|5.44||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|5.44|0.83|0.0078
91534970|NCT04319094|182947964|SUPERIORITY|||||||0.1408|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants.||||0.1408
91534971|NCT02042443|182947995|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.05|TWO_SIDED|95.0|1.01|4.03|||Log Rank|||||4.03|1.01|0.05
91534972|NCT01649427|182947999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority||||||0.0003|||||||ANCOVA|||||||0.0003
91534973|NCT02735187|182948005|SUPERIORITY|A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.||||||0.6469||||||A probability (P-Value) above 0.05 is considered not to be statistical significant.|t-test, 2 sided|||||||0.6469
91534974|NCT02138916|182948016|SUPERIORITY||Rate ratio|0.96||||0.649|TWO_SIDED|95.0|0.8|1.15|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.15|0.8|0.6490
91534975|NCT02138916|182948016|SUPERIORITY||Risk Ratio (RR)|0.83||||0.0525|TWO_SIDED|95.0|0.69|1.0|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.00|0.69|0.0525
91534976|NCT02138916|182948017|SUPERIORITY||Risk Ratio (RR)|1.07||||0.5236|TWO_SIDED|95.0|0.86|1.34|||Negative binomial|Model includes treatment group, region, number of exacerbations in the previous year.||||1.34|0.86|0.5236
91534977|NCT02138916|182948017|SUPERIORITY||Risk Ratio (RR)|1.02||||0.8812|TWO_SIDED|95.0|0.82|1.27|||Negative binomial|Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.||||1.27|0.82|0.8812
91534978|NCT02138916|182948018|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.755|TWO_SIDED|95.0|-0.035|0.048|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.048|-0.035|0.7550
91534979|NCT02138916|182948018|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.3285|TWO_SIDED|95.0|-0.021|0.062|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.062|-0.021|0.3285
91534980|NCT02138916|182948019|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.2906|TWO_SIDED|95.0|-2.887|0.865|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.865|-2.887|0.2906
91758413|NCT02227394|183409858|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|11.4||||0.034|TWO_SIDED|90.0|2.789|20.011|||t-test, 2 sided|||||20.011|2.789|0.034
91758414|NCT02227394|183409859|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|5.6||||0.427|TWO_SIDED|90.0|-6.323|17.523|||t-test, 2 sided|||||17.523|-6.323|0.427
91534981|NCT02138916|182948019|SUPERIORITY||Mean Difference (Final Values)|-2.136||||0.0264|TWO_SIDED|95.0|-4.02|-0.251|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.251|-4.020|0.0264
91758415|NCT04302545|183409862|OTHER|Other Primary outcomes were the extent of injury, operative time, blood loss and proportion of subjects receiving a blood transfusion. Postoperatively, subjects were assessed for secondary outcomes of UTI, micturition problems, and fistula formation during the hospital stay and for the next 3 months. Postoperative micturition problems were feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence.|Odds Ratio (OR)|-0.178|||<|0.0001|TWO_SIDED|95.0|-0.261|-0.094||The threshold for statistical significance was \<.05.|Regression, Linear|||"Null Hypothesis: During the cesarean section of women with adhesions of the previous cesarean section that obscure the bladder, the bladder injury rate is not significantly decreased in cystoinflation group compared to the control.~In this study, the bladder injury rate was seven times lesser in cystoinflation group compared to the control, thereby strongly supporting our hypothesis. The power of the study for bladder injury was 0.988, calculated with statistical software G'Power version 3.1."||-.094|-.261|<.0001
91758416|NCT04302545|183409863|OTHER||Odds Ratio (OR)|-211.776|||<|0.0001|TWO_SIDED|95.0|-290.7|-132.84|||Regression, Linear|||||-132.84|-290.70|<0.0001
91758417|NCT04302545|183409864|OTHER||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|-3.634|3.634|||Regression, Linear|||Null Hypothsis:Cystoinflation is ineffective to prevent bladder injury in adhesions of previous C-section.The cystoinflation was to be cosidered ineffective if proportion of bladder injury in study group was less than %0% of the control.The power of the study for bladder injury prevention was.988,calculated with statistical software G'Power version3.1.||3.634|-3.634|1
91758418|NCT04302545|183409865|OTHER||Odds Ratio (OR)|-1.093||||0.001|TWO_SIDED|95.0|-1.708|-0.479|||Regression, Linear|||||-.479|-1.708|.001
91534982|NCT02138916|182948020|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.6782|TWO_SIDED|95.0|-1.08|0.7|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.70|-1.08|0.6782
91534983|NCT02138916|182948020|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.0753|TWO_SIDED|95.0|-1.7|0.08|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.08|-1.70|0.0753
91534984|NCT02138916|182948021|SUPERIORITY||Mean Difference (Final Values)|-0.585||||0.0889|TWO_SIDED|95.0|-1.26|0.089|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.089|-1.260|0.0889
91534985|NCT02138916|182948021|SUPERIORITY||Mean Difference (Final Values)|-0.703||||0.0413|TWO_SIDED|95.0|-1.378|-0.028|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.028|-1.378|0.0413
91534986|NCT02138916|182948022|SUPERIORITY||Mean Difference (Final Values)|-0.348||||0.0728|TWO_SIDED|95.0|-0.728|0.032|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.032|-0.728|0.0728
91758419|NCT04302545|183409866|OTHER||Odds Ratio (OR)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.226|-0.073|||Regression, Linear|||||-0.073|-0.226|<0.0001
91758420|NCT04302545|183409867|OTHER||Odds Ratio (OR)|-0.103||||0.003|TWO_SIDED|95.0|-0.171|-0.035|||Regression, Linear|||||-0.035|-0.171|0.003
91758421|NCT04302545|183409868|OTHER||Odds Ratio (OR)|0.654||||0.336|TWO_SIDED|95.0|-0.682|1.991|||Regression, Linear|||||1.991|-0.682|.336
91758422|NCT04302545|183409869|OTHER||Odds Ratio (OR)|-0.393||||0.021|TWO_SIDED|95.0|-0.725|-0.06|||Regression, Linear|||||-0.06|-0.725|.021
91758423|NCT04302545|183409870|OTHER||Odds Ratio (OR)|-1.89|||<|0.0001|TWO_SIDED|95.0|-2.813|-0.963|||Regression, Linear|||||-0.963|-2.813|<0.0001
91758424|NCT04302545|183409871|OTHER||Odds Ratio (OR)|-1.318|||<|0.0001|TWO_SIDED|95.0|-2.021|-0.614|||Regression, Linear|||||-0.614|-2.021|<.0001
91758425|NCT04302545|183409873|OTHER||Odds Ratio (OR)|-0.065||||0.003|TWO_SIDED|95.0|-0.108|-0.023|||Regression, Linear|||||-.023|-.108|.003
91758426|NCT02516592|183409874|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.028|TWO_SIDED|95.0|0.005|0.084|||Mixed Models Analysis|||||0.084|0.005|0.028
91758427|NCT02516592|183409875|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.063|TWO_SIDED|95.0|-0.03|0.94|||Mixed Models Analysis|||||0.94|-0.03|0.063
91758428|NCT02516592|183409876|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.002|TWO_SIDED|95.0|0.037|0.167|||Mixed Models Analysis|||||0.167|0.037|0.002
91758429|NCT02516592|183409877|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.319|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||||0.4|-1.3|0.319
91758430|NCT02516592|183409878|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.662|TWO_SIDED|95.0|-0.2|0.13|||Mixed Models Analysis|||||0.13|-0.20|0.662
91758431|NCT00300365|183409881|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91758432|NCT01727336|183409911|OTHER||recommended dose for Part 2|0.9|||||TWO_SIDED||||||||The recommended dose level for Part 2 was determined to be 0.9 mg/kg|||||
91758433|NCT04118595|183409978|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
91758434|NCT04118595|183409979|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
91758435|NCT04118595|183409980|SUPERIORITY|||||||0.08|||||||ANCOVA|||||||0.08
91758436|NCT04118595|183409981|SUPERIORITY|||||||0.64|||||||ANCOVA|||||||0.64
91758437|NCT04118595|183409982|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
91758438|NCT04118595|183409983|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
91758439|NCT04118595|183409984|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.19
91758440|NCT04118595|183409985|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
91758441|NCT04118595|183409986|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
91758442|NCT04118595|183409987|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
91758443|NCT02684188|183410028|SUPERIORITY|||||||0.03||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.030
91758444|NCT02684188|183410028|SUPERIORITY|||||||0.025||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 7 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.025
91758445|NCT02684188|183410028|SUPERIORITY|||||||0.037||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 14 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.037
91758446|NCT02684188|183410028|SUPERIORITY|||||||0.011||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 21 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.011
91758447|NCT02684188|183410028|SUPERIORITY|||||||0.05||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 30 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.050
91758448|NCT02684188|183410028|SUPERIORITY|||||||0.055|||||||Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 60 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.055
91758449|NCT02684188|183410028|SUPERIORITY|||||||0.137||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 90 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.137
91758450|NCT02684188|183410029|SUPERIORITY|||||||0.279||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.279
91512509|NCT00807092|182896615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.178|STANDARD_ERROR_OF_MEAN|1.0||0.2412||95.0|-0.802|3.157||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Breakfast|"Null hypothesis and alternative hypothesis for breakfast:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol\*h/L"||3.157|-0.802|0.2412
91512510|NCT00807092|182896615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.318|STANDARD_ERROR_OF_MEAN|1.216||0.794||95.0|-2.724|2.087||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Lunch|"Null hypothesis and alternative hypothesis for lunch:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol\*h/L"||2.087|-2.724|0.794
91534987|NCT02138916|182948022|SUPERIORITY||Mean Difference (Final Values)|-0.487||||0.0121|TWO_SIDED|95.0|-0.868|-0.107|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.107|-0.868|0.0121
91534988|NCT02138916|182948023|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0235|TWO_SIDED|95.0|-0.077|-0.006|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.006|-0.077|0.0235
91759933|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-20.44|-6.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.57|-20.44|
91759934|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.25|||||TWO_SIDED|95.0|-14.65|0.16||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-14.65|
91759935|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.03|||||TWO_SIDED|95.0|-19.38|-4.68||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.68|-19.38|
91759936|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.72|||||TWO_SIDED|95.0|-23.1|-8.35||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.35|-23.10|
91534989|NCT02138916|182948023|SUPERIORITY||Mean Difference (Final Values)|-0.044||||0.0158|TWO_SIDED|95.0|-0.08|-0.008|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.008|-0.080|0.0158
91534990|NCT02138916|182948027|SUPERIORITY||Rate ratio|1.09||||0.408|TWO_SIDED|95.0|0.89|1.34|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.34|0.89|0.4080
91534991|NCT02138916|182948027|SUPERIORITY||Rate ratio|0.98||||0.8688|TWO_SIDED|95.0|0.8|1.21|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.21|0.80|0.8688
91534992|NCT02138916|182948028|SUPERIORITY||Odds Ratio (OR)|0.9||||0.485|TWO_SIDED|95.0|0.66|1.22|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.22|0.66|0.4850
91758451|NCT02684188|183410029|SUPERIORITY|||||||0.211||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.211
91758452|NCT02684188|183410029|SUPERIORITY|||||||0.424||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.424
91758453|NCT02684188|183410029|SUPERIORITY|||||||0.191||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.191
91758454|NCT02684188|183410029|SUPERIORITY|||||||0.478||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.478
91758455|NCT02684188|183410029|SUPERIORITY|||||||0.452||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.452
91758456|NCT02684188|183410029|SUPERIORITY|H0: There is no difference in the proportion of patients with at least one ED visits by day 90 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.||||||0.381||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic||||For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.381
91758457|NCT02684188|183410030|SUPERIORITY|||||||0.502||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.502
91534993|NCT02138916|182948028|SUPERIORITY||Odds Ratio (OR)|0.89||||0.4489|TWO_SIDED|95.0|0.65|1.21|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.21|0.65|0.4489
91534994|NCT02138916|182948030|SUPERIORITY||Rate ratio|1.06||||0.7733|TWO_SIDED|95.0|0.73|1.53|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.53|0.73|0.7733
91534995|NCT02138916|182948030|SUPERIORITY||Rate ratio|0.58||||0.0114|TWO_SIDED|95.0|0.39|0.89|||Nagative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.89|0.39|0.0114
91534996|NCT05750745|182948047|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.0871|TWO_SIDED|95.0|-0.36|0.02|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test minus negative control.|||0.02|-0.36|0.0871
91534997|NCT05750745|182948048|SUPERIORITY||Adjusted Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|3.548||0.0972|TWO_SIDED|95.0|-0.78|13.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||13.20|-0.78|0.0972
91534998|NCT05750745|182948049|SUPERIORITY||Adjusted Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|3.16||0.0671|TWO_SIDED|95.0|-12.04|0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.41|-12.04|0.0671
91534999|NCT05750745|182948050|SUPERIORITY||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0673|TWO_SIDED|95.0|-0.27|0.01|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.01|-0.27|0.0673
91535000|NCT05750745|182948051|SUPERIORITY||Adjusted Mean Difference|2.38|STANDARD_ERROR_OF_MEAN|2.446||0.405|TWO_SIDED|95.0|-2.44|7.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||7.20|-2.44|0.4050
91535001|NCT05750745|182948052|SUPERIORITY||Adjusted Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|2.656||0.0346|TWO_SIDED|95.0|-10.88|-0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||-0.41|-10.88|0.0346
91535002|NCT05750745|182948053|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.085||0.8256|TWO_SIDED|95.0|-0.15|0.19|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||0.19|-0.15|0.8256
91535003|NCT05750745|182948053|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.117||0.5314|TWO_SIDED|95.0|-0.16|0.3|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||0.30|-0.16|0.5314
91535004|NCT05750745|182948054|SUPERIORITY||Adjusted Mean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.99||0.5575|TWO_SIDED|95.0|-8.48|3.3|||van Elteren Test|P-value was from the Van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||3.30|-8.48|0.5575
91535005|NCT05750745|182948054|SUPERIORITY||Adjusted Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|4.308||0.7717|TWO_SIDED|95.0|-9.6|7.37|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||7.37|-9.60|0.7717
91535006|NCT05750745|182948055|SUPERIORITY||Adjusted Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|3.235||0.818|TWO_SIDED|95.0|-5.63|7.12|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||7.12|-5.63|0.8180
91535007|NCT05750745|182948055|SUPERIORITY||Adjusted Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|3.834||0.3322|TWO_SIDED|95.0|-3.83|11.28|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||11.28|-3.83|0.3322
91535008|NCT04888585|182948077|SUPERIORITY||Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|11.5|31.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||31.0|11.5|<0.001
91535009|NCT04888585|182948077|SUPERIORITY||Response Rate Difference|26.6|||<|0.001|TWO_SIDED|95.0|16.5|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||36.7|16.5|<0.001
91535010|NCT04888585|182948077|SUPERIORITY||Response Rate Difference|37.7|||<|0.001|TWO_SIDED|95.0|27.4|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||48.1|27.4|<0.001
91512511|NCT00807092|182896615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.749||||0.3093||95.0|-2.2|0.703||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Dinner|"Null hypothesis and alternative hypothesis for dinner:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol\*h/L"||0.703|-2.2|0.3093
91512512|NCT00807092|182896616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.448|STANDARD_ERROR_OF_MEAN|0.261||0.0891||95.0|-0.069|0.964||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.964|-0.069|0.0891
91512513|NCT00807092|182896618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.495|STANDARD_ERROR_OF_MEAN|0.247||0.0472||95.0|0.006|0.984||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.984|0.0060|0.0472
91512514|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.676||95.0|-0.41|0.63||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 2) value of BG as covariate|Before breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.63|-0.41|0.676
91512515|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.026||95.0|0.15|2.31||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.31|0.15|0.026
91512516|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.5||95.0|-0.53|1.08||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.08|-0.53|0.5
91512517|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.747||95.0|-0.86|1.19||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.19|-0.86|0.747
91512518|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.581||95.0|-1.23|0.69||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.69|-1.23|0.581
91512519|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.326||95.0|-1.42|0.48||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.48|-1.42|0.326
91535011|NCT04888585|182948077|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|13.8|32.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||32.6|13.8|<0.001
91535012|NCT04888585|182948078|SUPERIORITY||Least Squares (LS) Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14|||Mixed Models Analysis|MMRM includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg - Placebo|||-0.14|-0.87|0.007
91535013|NCT04888585|182948078|SUPERIORITY||Least Squares (LS) Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.64|-1.38|<0.001
91535014|NCT04888585|182948078|SUPERIORITY||Least Squares (LS) Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.8|-1.05|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-1.05|-1.80|<0.001
91758458|NCT02684188|183410030|SUPERIORITY|||||||0.286||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 7 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.286
91758459|NCT02684188|183410030|SUPERIORITY|||||||0.347||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 14 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.347
91758460|NCT02684188|183410030|SUPERIORITY|||||||0.25||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 21 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.250
91512520|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.643||95.0|-0.61|0.99||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Bedtime|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.99|-0.61|0.643
91512521|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.008||95.0|0.21|1.33||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|3 AM|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.33|0.21|0.0080
91512522|NCT00807092|182896619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.274||95.0|-0.22|0.75||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Average|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.75|-0.22|0.274
91512523|NCT00807092|182896620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.062||95.0|-0.05|2.04||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Breakfast|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.04|-0.05|0.062
91512524|NCT00807092|182896620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.933||95.0|-1.12|1.22||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Lunch|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.22|-1.12|0.933
91512525|NCT00807092|182896620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.922||95.0|-1.16|1.05||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Dinner|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.05|-1.16|0.922
91512526|NCT00807092|182896620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.313||95.0|-0.28|0.85||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Average|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.85|-0.28|0.313
91512527|NCT00807092|182896621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.371||0.6149||95.0|-0.547|0.921||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate||The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||0.921|-0.547|0.6149
91512528|NCT00807092|182896622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.328|STANDARD_ERROR_OF_MEAN|0.577||0.5706||95.0|-0.813|1.468||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of GA as covariate||"The null hypothesis (H0) was:~H0: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment≠0 %"||1.468|-0.813|0.5706
91512529|NCT00807092|182896623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.113||0.8598||95.0|-0.243|0.243||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate||"The null hypothesis (H0) was:~H0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%"||0.243|-0.243|0.8598
91512530|NCT00807092|182896624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.128||0.671||95.0|-0.307|0.198||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 3.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.198|-0.307|0.671
91512531|NCT00807092|182896624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.038||0.7544||95.0|-0.088|0.064||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 2.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.064|-0.088|0.7544
91512532|NCT01229228|182896639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.417|STANDARD_ERROR_OF_MEAN|2.7891|<|0.001|TWO_SIDED|95.0|16.923|27.91|||ANCOVA|||||27.910|16.923|<0.001
91512533|NCT01807585|182896641|NON_INFERIORITY|Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.|Risk Difference (RD)|3.5|||<|0.0001|TWO_SIDED|95.0|-0.7|7.6|||One tailed Z-test|||Last Observation Carried Forward (LOCF)||7.6|-0.7|<0.0001
91512534|NCT02617589|182896648|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0037|TWO_SIDED|95.0|1.09|1.58|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.58|1.09|0.0037
91512535|NCT02617589|182896649|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.43|||||TWO_SIDED|95.0|1.19|1.71|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.71|1.19|
91512536|NCT02617589|182896653|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0024|TWO_SIDED|95.0|1.1|1.55|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.55|1.10|0.0024
91512537|NCT03062891|182896660|SUPERIORITY||Slope|0.54||||0.572|TWO_SIDED|95.0|-1.33|2.4|||Regression, Linear|||This analysis looked at the interaction between baseline anxiety symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.40|-1.33|.572
91512538|NCT03062891|182896661|SUPERIORITY||Slope|0.08||||0.934|TWO_SIDED|95.0|-1.82|1.98|||Regression, Linear|||This analysis looked at the interaction between baseline depression symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.98|-1.82|.934
91512539|NCT03062891|182896662|SUPERIORITY||Slope|1.07||||0.253|TWO_SIDED|95.0|-0.76|2.89|||Regression, Linear|||This analysis looked at the interaction between attentional problems and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.89|-0.76|.253
91512540|NCT03062891|182896663|SUPERIORITY||Slope|1.2||||0.215|TWO_SIDED|95.0|-0.7|3.1|||Regression, Linear|||This analysis looked at the interaction between baseline paranois and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.10|-0.70|.215
91512541|NCT03062891|182896663|SUPERIORITY||Slope|1.14||||0.254|TWO_SIDED|95.0|-0.83|3.11|||Regression, Linear|||This analysis looked at the interaction between baseline hallucinations and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.11|-0.83|.254
91512542|NCT03062891|182896663|SUPERIORITY||Slope|-0.27||||0.778|TWO_SIDED|95.0|-2.13|1.59|||Regression, Linear|||This analysis looked at the interaction between baseline cognitive disorganization and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.59|-2.13|.778
91512543|NCT03062891|182896664|SUPERIORITY||Slope|-0.25||||0.8|TWO_SIDED|95.0|-2.16|1.67|||Regression, Linear|||This analysis looked at the interaction between baseline positive mental health and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.67|-2.16|.800
91512544|NCT03062891|182896665|SUPERIORITY||Slope|0.59||||0.525|TWO_SIDED|95.0|-1.25|2.44|||Regression, Linear|||This analysis looked at the interaction between baseline perceived stress and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.44|-1.25|.525
91512545|NCT03062891|182896666|SUPERIORITY||Slope|1.3||||0.14|TWO_SIDED|95.0|-0.43|3.03|||Regression, Linear|||This analysis looked at the interaction between baseline threatening life events and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.03|-0.43|.140
91512546|NCT03062891|182896667|SUPERIORITY||Slope|-2.58||||0.03|TWO_SIDED|95.0|-4.9|-0.25|||Generalized estimating equation|||This analysis looked at the effect of group on changes in anxiety symptoms across the intervention period.||-0.25|-4.90|.030
91512547|NCT03062891|182896668|SUPERIORITY||Slope|-0.63||||0.456|TWO_SIDED|95.0|-2.24|1.01|||Generalized estimating equation|||This analysis looked at the effect of group on changes in depression symptoms across the intervention period.||1.01|-2.24|.456
91535015|NCT04888585|182948078|SUPERIORITY||Least Squares (LS) Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||-0.26|-0.99|<0.001
91535016|NCT04888585|182948079|SUPERIORITY||Least Squares (LS) Mean Difference|-4.56||||0.014|TWO_SIDED|95.0|-8.21|-0.92|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||-0.92|-8.21|0.014
91535017|NCT04888585|182948079|SUPERIORITY||Least Squares (LS) Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.7|-4.31|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-4.31|-11.70|<0.001
91535018|NCT04888585|182948079|SUPERIORITY||Least Squares (LS) Mean Difference|-11.41|||<|0.001|TWO_SIDED|95.0|-15.1|-7.73|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-7.73|-15.10|<0.001
91535019|NCT04888585|182948079|SUPERIORITY||Least Squares (LS) Mean Difference|-5.29||||0.004|TWO_SIDED|95.0|-8.89|-1.69|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-1.69|-8.89|0.004
91535020|NCT04888585|182948080|SUPERIORITY||Response Rate Difference|24.7|||<|0.001|TWO_SIDED|95.0|12.1|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||37.3|12.1|<0.001
91535021|NCT04888585|182948080|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|17.4|42.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||42.9|17.4|<0.001
91535022|NCT04888585|182948080|SUPERIORITY||Response Rate Difference|45.4|||<|0.001|TWO_SIDED|95.0|33.5|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||57.4|33.5|<0.001
91535023|NCT04888585|182948080|SUPERIORITY||Response Rate Difference|24.6|||<|0.001|TWO_SIDED|95.0|11.9|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||37.3|11.9|<0.001
91535024|NCT04888585|182948081|SUPERIORITY||Response Rate Difference|6.5||||0.031|TWO_SIDED|95.0|0.6|12.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||12.4|0.6|0.031
91535025|NCT04888585|182948081|SUPERIORITY||Response Rate Difference|9.8||||0.007|TWO_SIDED|95.0|2.7|17.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||17.0|2.7|0.007
91535026|NCT04888585|182948081|SUPERIORITY||Response Rate Difference|10.9||||0.004|TWO_SIDED|95.0|3.6|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||18.2|3.6|0.004
91535027|NCT04888585|182948081|SUPERIORITY||Response Rate Difference|0.9||||0.709|TWO_SIDED|95.0|-4.0|5.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||5.9|-4.0|0.709
91535028|NCT04888585|182948082|SUPERIORITY||Response Rate Difference|16.9||||0.006|TWO_SIDED|95.0|4.9|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||28.9|4.9|0.006
91512548|NCT03062891|182896669|SUPERIORITY||Slope|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.53|||Generalized estimating equation|||This analysis looked at the effect of group on changes attentional problems across the intervention period.||0.53|-5.21|.110
91512549|NCT03062891|182896670|SUPERIORITY||Slope|-1.69||||0.041|TWO_SIDED|95.0|-3.31|-0.07|||Generalized estimating equations|||This analysis looked at the effect of group on changes in psychotic experiences (paranoia) across the intervention period.||-0.07|-3.31|.041
91535029|NCT04888585|182948082|SUPERIORITY||Response Rate Difference|25.8|||<|0.001|TWO_SIDED|95.0|13.5|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||38.1|13.5|<0.001
91535030|NCT04888585|182948082|SUPERIORITY||Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|18.9|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||44.2|18.9|<0.001
91535031|NCT04888585|182948082|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|11.0|35.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||35.4|11.0|<0.001
91535032|NCT04888585|182948083|SUPERIORITY||Response Rate Difference|14.1||||0.022|TWO_SIDED|95.0|2.0|26.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||26.2|2.0|0.022
91535033|NCT04888585|182948083|SUPERIORITY||Response Rate Difference|22.8|||<|0.001|TWO_SIDED|95.0|10.0|35.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||35.5|10.0|<0.001
91535034|NCT04888585|182948083|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|11.6|37.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||37.0|11.6|<0.001
91535035|NCT04888585|182948083|SUPERIORITY||Response Rate Difference|12.6||||0.042|TWO_SIDED|95.0|0.5|24.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.7|0.5|0.042
91535036|NCT04888585|182948084|SUPERIORITY||Response Rate Difference|5.1||||0.296|TWO_SIDED|95.0|-4.4|14.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||14.6|-4.4|0.296
91535037|NCT04888585|182948084|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|8.7|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||30.2|8.7|<0.001
91512550|NCT03062891|182896670|SUPERIORITY||Slope|-0.22||||0.531|TWO_SIDED|95.0|-0.92|0.48|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (hallucinations) across the intervention period.||0.48|-0.92|.531
91512551|NCT03062891|182896670|SUPERIORITY||Slope|-0.37||||0.13|TWO_SIDED|95.0|-0.84|0.11|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (cognitive disorganization) across the intervention period.||0.11|-0.84|.130
91512552|NCT03062891|182896671|SUPERIORITY||Slope|0.07||||0.916|TWO_SIDED|95.0|-1.17|1.3|||Generalized estimating equation|||This analysis looked at the effect of group on changes in positive mental health across the intervention period.||1.30|-1.17|.916
91512553|NCT03062891|182896672|SUPERIORITY||Slope|-2.03||||0.027|TWO_SIDED|95.0|-3.83|-0.23|||Generalized estimating equation|||This analysis looked at the effect of group on changes in perceived stress across the intervention period.||-0.23|-3.83|.027
91512554|NCT03062891|182896674|SUPERIORITY||Odds Ratio (OR)|1.36||||0.296|TWO_SIDED|95.0|0.77|2.4|||Regression, Logistic|||Assocation between baseline anxiety symptoms and exploding head syndrome||2.40|0.77|.296
91512555|NCT03062891|182896674|SUPERIORITY||Odds Ratio (OR)|0.69||||0.065|TWO_SIDED|95.0|0.47|1.02|||Regression, Logistic|||Assocation between baseline insomnia symptoms and exploding head syndrome||1.02|0.47|.065
91512556|NCT03062891|182896674|SUPERIORITY||Odds Ratio (OR)|0.67||||0.145|TWO_SIDED|95.0|0.39|1.15|||Regression, Logistic|||Assocation between baseline depression symptoms and exploding head syndrome||1.15|0.39|.145
91535038|NCT04888585|182948084|SUPERIORITY||Response Rate Difference|25.5|||<|0.001|TWO_SIDED|95.0|14.3|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||36.7|14.3|<0.001
91512557|NCT03062891|182896674|SUPERIORITY||Odds Ratio (OR)|1.26||||0.398|TWO_SIDED|95.0|0.73|2.19|||Regression, Logistic|||Assocation between baseline life stress and exploding head syndrome||2.19|0.73|.398
91512558|NCT03062891|182896674|SUPERIORITY||Odds Ratio (OR)|1.72||||0.001|TWO_SIDED|95.0|1.24|2.38|||Regression, Logistic|||Assocation between sleep paralysis and exploding head syndrome||2.38|1.24|.001
91512559|NCT01129141|182896679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.198|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|95.0|-22.86|-11.53|||Mixed Models Analysis|||||-11.53|-22.86|<.0001
91512560|NCT02076412|182896681|SUPERIORITY||Risk Difference (RD)|13.8||||0.1519|TWO_SIDED|95.0|0.5|27.1|||Fisher Exact||Confidence interval for treatment difference (risk difference) was based on the normal approximation|||27.1|0.5|0.1519
91512561|NCT02076412|182896686|SUPERIORITY||Risk Difference (RD)|-0.01||||0.4927|TWO_SIDED|95.0|-0.05|0.02||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.02|-0.05|0.4927
91512562|NCT02076412|182896687|SUPERIORITY||Risk Difference (RD)|-0.12||||0.2499|TWO_SIDED|95.0|-0.32|0.09||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.09|-0.32|0.2499
91512563|NCT00958880|182896688|SUPERIORITY_OR_OTHER||Slope|10.46||||0.015||95.0|||||Regression, Linear|||||||.015
91512564|NCT00958880|182896689|SUPERIORITY_OR_OTHER||Slope|0.03||||0.575||95.0|||||Regression, Linear|||||||.575
91512565|NCT01516879|182896696|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.97|STANDARD_ERROR_OF_MEAN|2.1|<|0.001|TWO_SIDED|95.0|-61.08|-52.85|||Repeated measures linear effects model|The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.85|-61.08|<0.001
91512566|NCT01516879|182896697|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-62.3|-53.3|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-53.3|-62.3|<0.001
91512567|NCT01516879|182896698|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|75.8|||<|0.001|TWO_SIDED|95.0|70.8|79.7|||Cochran-Mantel-Haenszel|CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.|Treatment difference using placebo as the reference.|||79.7|70.8|<0.001
91512568|NCT01516879|182896699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.51|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-60.57|-54.45|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-54.45|-60.57|<0.001
91512569|NCT01516879|182896700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.15|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-37.19|-33.11|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.11|-37.19|<0.001
91512570|NCT01516879|182896701|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.45|STANDARD_ERROR_OF_MEAN|1.41|<|0.001|TWO_SIDED|95.0|-36.21|-30.68|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-30.68|-36.21|<0.001
91512571|NCT01516879|182896702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.27|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-54.25|-46.28|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-46.28|-54.25|<0.001
91535039|NCT04888585|182948084|SUPERIORITY||Response Rate Difference|14.1||||0.007|TWO_SIDED|95.0|3.8|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.5|3.8|0.007
91535040|NCT04888585|182948085|SUPERIORITY||Response Rate Difference|7.1||||0.017|TWO_SIDED|95.0|1.3|13.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||13.0|1.3|0.017
91758461|NCT02684188|183410030|SUPERIORITY|||||||0.22||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 30 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.220
91758462|NCT02684188|183410030|SUPERIORITY|||||||0.116||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 60 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.116
91758463|NCT02684188|183410030|SUPERIORITY|||||||0.126||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 90 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.126
91758464|NCT02684188|183410031|SUPERIORITY|||||||0.597||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.597
91758465|NCT02684188|183410031|SUPERIORITY|||||||0.504||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.504
91512572|NCT01516879|182896703|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.21|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-47.56|-40.85|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-40.85|-47.56|<0.001
91758466|NCT02684188|183410031|SUPERIORITY|||||||0.558||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.558
91758467|NCT02684188|183410031|SUPERIORITY|||||||0.472||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.472
91758468|NCT02684188|183410031|SUPERIORITY|||||||0.462||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.462
91758469|NCT02684188|183410031|SUPERIORITY|||||||0.394||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.394
91758470|NCT02684188|183410031|SUPERIORITY|||||||0.368||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 90; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.368
91758471|NCT02684188|183410032|SUPERIORITY|||||||0.946||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||The following hypotheses were tested: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.946
91758472|NCT02684188|183410032|SUPERIORITY|||||||0.613|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.613
91758473|NCT02684188|183410032|SUPERIORITY|||||||0.541||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.541
91758474|NCT02684188|183410032|SUPERIORITY|||||||0.765||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|For day 21, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.765
91535041|NCT04888585|182948085|SUPERIORITY||Response Rate Difference|2.0||||0.424|TWO_SIDED|95.0|-2.8|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||6.8|-2.8|0.424
91758475|NCT02684188|183410032|SUPERIORITY|||||||0.919||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.919
91512573|NCT01516879|182896704|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.14|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-40.41|-33.87|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.87|-40.41|<0.001
91512574|NCT01516879|182896705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.21|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-49.79|-42.63|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-42.63|-49.79|<0.001
91512575|NCT01516879|182896706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.35|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-26.15|-18.55|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.55|-26.15|<0.001
91512576|NCT01516879|182896707|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-11.54|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.21|-5.86|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-5.86|-17.21|<0.001
91512577|NCT01516879|182896708|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.42|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|3.28|7.56|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||7.56|3.28|<0.001
91512578|NCT01516879|182896709|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.15|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.23|-18.08|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.08|-40.23|<0.001
91512579|NCT01516879|182896710|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|1.84||0.94|TWO_SIDED|95.0|-3.76|3.48|||ANCOVA|The ANCOVA model includes treatment group and stratification factor as covariates.|Treatment difference using placebo as the reference.|||3.48|-3.76|0.94
91512580|NCT03837496|182896791|SUPERIORITY||Slope|-0.66||||0.504|TWO_SIDED|95.0|-2.59|1.27||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression.||Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||1.27|-2.59|.504
91512581|NCT03837496|182896791|SUPERIORITY||Slope|-0.17||||0.225|TWO_SIDED|95.0|-0.44|-0.1||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression||Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||-0.10|-0.44|.225
91512582|NCT03837496|182896792|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.63|TWO_SIDED|95.0|-0.4|0.66||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||0.66|-0.40|.630
91512583|NCT03837496|182896793|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.186|TWO_SIDED|95.0|-1.27|6.44||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||6.44|-1.27|.186
91512584|NCT03837496|182896794|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.562|TWO_SIDED|95.0|-3.49|1.91||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||1.91|-3.49|.562
91512585|NCT04666441|182896819|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0004|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.25|-0.88|0.0004
91512586|NCT04666441|182896819|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.34|-0.99|<0.0001
91512587|NCT04666441|182896819|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.89|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.89|0.0007
91512588|NCT04666441|182896819|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.38|-1.05|<0.0001
91535042|NCT04888585|182948085|SUPERIORITY||Response Rate Difference|2.6||||0.303|TWO_SIDED|95.0|-2.3|7.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||7.5|-2.3|0.303
91759937|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-21.27|-6.63||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.63|-21.27|
91512589|NCT04666441|182896819|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0006||95.0|-0.88|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.88|0.0006
91512590|NCT04666441|182896819|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007||95.0|-0.87|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.87|0.0007
91512591|NCT04666441|182896820|SUPERIORITY||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.72|-0.23|||ANCOVA|||||-0.23|-0.72|0.0002
91512592|NCT04666441|182896820|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.82|-0.32|||ANCOVA|||||-0.32|-0.82|<0.0001
91512593|NCT04666441|182896820|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.83|-0.33|||ANCOVA|||||-0.33|-0.83|<0.0001
91512594|NCT04666441|182896820|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.75|-0.24|||ANCOVA|||||-0.24|-0.75|0.0002
91512595|NCT04666441|182896820|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.004||95.0|-0.62|-0.12|||ANCOVA|||||-0.12|-0.62|0.0040
91535043|NCT04888585|182948085|SUPERIORITY||Response Rate Difference|1.3||||0.551|TWO_SIDED|95.0|-2.9|5.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||5.4|-2.9|0.551
91512596|NCT04666441|182896820|SUPERIORITY||Difference of LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0007||95.0|-0.67|-0.18|||ANCOVA|||||-0.18|-0.67|0.0007
91535044|NCT04888585|182948086|SUPERIORITY||Least Squares (LS) Mean Difference|-0.18||||0.022|TWO_SIDED|95.0|-0.33|-0.03|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|ABBV-154 40mg EOW - Placebo|||-0.03|-0.33|0.022
91512597|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.82|<0.0001
91512598|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.90|<0.0001
91512599|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.42|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.97|<0.0001
91512600|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.19|-0.58|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.58|-1.19|<0.0001
91512601|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.84|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.84|<0.0001
91512602|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.95|-0.43|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.95|<0.0001
91512603|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.98|<0.0001
91512604|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.64|-1.25|<0.0001
91512605|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.87|-0.37|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.37|-0.87|<0.0001
91512606|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.93|-0.42|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.93|<0.0001
91512607|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.99|<0.0001
91512608|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.61|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.61|-1.25|<0.0001
91512609|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.31|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.80|<0.0001
91512610|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.38|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.38|-0.89|<0.0001
91512611|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.43|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.97|<0.0001
91512612|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.15|<0.0001
91512613|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.76|-0.27|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.76|<0.0001
91512614|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.83|<0.0001
91535045|NCT04888585|182948086|SUPERIORITY||Least Squares (LS) Mean Difference|-0.25||||0.001|TWO_SIDED|95.0|-0.41|-0.1|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.10|-0.41|0.001
91535046|NCT04888585|182948086|SUPERIORITY||Least Squares (LS) Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-0.17|-0.48|<0.001
91758476|NCT02684188|183410032|SUPERIORITY|||||||0.999||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.999
91758477|NCT02684188|183410032|SUPERIORITY|||||||0.995|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.995
91758478|NCT02684188|183410033|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF12 Physical Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, and the number of people in a household. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.371||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.371, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF12 Physical Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF12 Physical Health scores differ between the standard and enhanced discharge groups.||||0.371
91512615|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.82|<0.0001
91512616|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.95|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.95|<0.0001
91512617|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.73|0.0002
91512618|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.82|<0.0001
91512619|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.87|<0.0001
91512620|NCT04666441|182896821|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.16|<0.0001
91512621|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.18|-0.64|0.0005
91512622|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|<0.0001
91512623|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.75|-0.26|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.26|-0.75|<0.0001
91512624|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.88|<0.0001
91512625|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12||0.0003|TWO_SIDED|95.0|-0.69|-0.21|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.21|-0.69|0.0003
91512626|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.77|-0.29|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.77|<0.0001
91512627|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.78|-0.29|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.78|<0.0001
91512628|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.41|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.41|-0.98|<0.0001
91512629|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.72|-0.25|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.25|-0.72|<0.0001
91512630|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.74|-0.28|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.74|<0.0001
91512631|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.3|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.30|-0.79|<0.0001
91512632|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.4|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.99|<0.0001
91512633|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0009|TWO_SIDED|95.0|-0.63|-0.16|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.63|0.0009
91512634|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|0.0001
91512635|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.77|-0.27|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.77|<0.0001
91535047|NCT04888585|182948086|SUPERIORITY||Least Squares (LS) Mean Difference|-0.21||||0.007|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-0.06|-0.36|0.007
91535048|NCT04927975|182948087|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.6||||0.304|TWO_SIDED|95.0|-22.18|6.97|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||6.97|-22.18|0.304
91758479|NCT02684188|183410034|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF-12 Mental Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and county. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.232||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.232, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF-12 Mental Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF-12 Mental Health scores differ between the standard and enhanced discharge groups.||||0.232
91512636|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.34|-0.92|<0.0001
91512637|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.0046|TWO_SIDED|95.0|-0.57|-0.1|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.10|-0.57|0.0046
91512638|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.15|-0.62|0.0011
91512639|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0029|TWO_SIDED|95.0|-0.62|-0.13|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.13|-0.62|0.0029
91512640|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.012|TWO_SIDED|95.0|-0.66|-0.08|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.08|-0.66|0.0120
91512641|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.09|-0.56|0.0062
91512642|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.16|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.62|0.0011
91512643|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.13||0.0011|TWO_SIDED|95.0|-0.66|-0.17|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.17|-0.66|0.0011
91512644|NCT04666441|182896822|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.29|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.87|0.0001
91512645|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.007||95.0|-0.85|-0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.14|-0.85|0.0070
91759938|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.94|||||TWO_SIDED|95.0|-13.31|1.43||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.43|-13.31|
91512646|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.33|-1.06|0.0002
91512647|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.19||0.0008||95.0|-1.0|-0.26|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.26|-1.00|0.0008
91512648|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.19||0.0125||95.0|-0.85|-0.1|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.10|-0.85|0.0125
91512649|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0696||95.0|-0.7|0.03|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||0.03|-0.70|0.0696
91512650|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0187|TWO_SIDED|95.0|-0.79|-0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.07|-0.79|0.0187
91512651|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.96|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.39|-0.52|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.52|-1.39|<0.0001
91512652|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.53|-0.64|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.64|-1.53|<0.0001
91512653|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.48|-0.59|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.59|-1.48|<0.0001
91512654|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.5|-0.6|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.60|-1.50|<0.0001
91535049|NCT04927975|182948087|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-21.27||||0.005|TWO_SIDED|95.0|-36.02|-6.52|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-6.52|-36.02|0.005
91535050|NCT04927975|182948087|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-19.6||||0.013|TWO_SIDED|95.0|-35.04|-4.16|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.16|-35.04|0.013
91535051|NCT04927975|182948088|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.9||||0.1|TWO_SIDED|95.0|-1.3|15.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||15.2|-1.3|0.100
91535052|NCT04927975|182948088|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|17.8||||0.002|TWO_SIDED|95.0|6.5|29.0|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||29.0|6.5|0.002
91535053|NCT04927975|182948088|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|11.7||||0.026|TWO_SIDED|95.0|1.4|21.9|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||21.9|1.4|0.026
91535054|NCT04927975|182948089|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.6||||0.327|TWO_SIDED|95.0|-6.6|19.7|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||19.7|-6.6|0.327
91535055|NCT04927975|182948089|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|29.3|||<|0.001|TWO_SIDED|95.0|13.8|44.9|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||44.9|13.8|<0.001
91535056|NCT04927975|182948089|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|28.7|||<|0.001|TWO_SIDED|95.0|12.6|44.7|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||44.7|12.6|<0.001
91758480|NCT02684188|183410035|SUPERIORITY|||||||0.806|||||||ANCOVA|||The following hypotheses were tested: H0: There is no difference in the mean CTM3 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean CTM3 rating than patients in the standard discharge group.|An analysis of covariance was used to model the CTM3 discharge planning score as a function of treatment group. An ANOVA F-test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of patient age and income. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, County, Number in Household, LACE+ score, and PAM10 score did not differ in their mean CTM3 scores so were not retained in the model.|||0.806
91535057|NCT04927975|182948090|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.7||||0.34|TWO_SIDED|95.0|-3.9|11.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||11.2|-3.9|0.340
91759939|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.16|||||TWO_SIDED|95.0|-23.54|-8.79||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.79|-23.54|
91535058|NCT04927975|182948090|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.8||||0.358|TWO_SIDED|95.0|-4.3|11.8|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||11.8|-4.3|0.358
91535059|NCT04927975|182948090|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|9.1||||0.027|TWO_SIDED|95.0|1.0|17.2|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||17.2|1.0|0.027
91535060|NCT04927975|182948091|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.45||||0.12|TWO_SIDED|95.0|-16.86|1.96|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||1.96|-16.86|0.120
91535061|NCT04927975|182948091|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-10.84||||0.026|TWO_SIDED|95.0|-20.37|-1.32|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-1.32|-20.37|0.026
91535062|NCT04927975|182948091|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-14.27||||0.005|TWO_SIDED|95.0|-24.24|-4.3|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.30|-24.24|0.005
91535063|NCT04927975|182948092|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.9||||0.545|TWO_SIDED|95.0|-8.3|4.4|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||4.4|-8.3|0.545
91535064|NCT04927975|182948092|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|1.9||||0.565|TWO_SIDED|95.0|-4.5|8.3|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||8.3|-4.5|0.565
91535065|NCT04927975|182948092|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.1||||0.754|TWO_SIDED|95.0|-7.8|5.6|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||5.6|-7.8|0.754
91535066|NCT05550337|182948132|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|0.998|||||TWO_SIDED|90.0|0.927|1.076||||||||1.076|0.927|
91758481|NCT02684188|183410036|SUPERIORITY|||||||0.742|||||||ANOVA|||The following hypotheses were tested: H0: There is no difference in the mean RTM14 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean RTM14 rating than patients in the standard discharge group.|A repeated measures ANOVA model (over the 6 time measurement periods) was used to model the RTM14 score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and whether or not a patient had visited a hospital or ED prior to that day. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, Number in household, LACE+ score, and PAM10 score were not significant in explaining SF-12 scores so were not retained in the model.|||0.742
91758482|NCT02684188|183410037|SUPERIORITY|||||||0.717||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.717
91535067|NCT05550337|182948133|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the non-inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|1.116|||||TWO_SIDED|90.0|1.017|1.228||||||||1.228|1.017|
91535068|NCT02266329|182948143|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|1.6||0.034|TWO_SIDED|95.0|-6.9|-0.8||The significance of the study visit by treatment interaction with study visit coded as baseline, 4 weeks, 8 weeks, and 12 weeks.|Mixed Models Analysis|||Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.||-0.8|-6.9|0.034
91535069|NCT02926937|182948165|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.975|-0.415|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.415|-0.975|<0.0001
91535070|NCT02926937|182948166|SUPERIORITY||Difference in LS Mean|-0.565||||0.0141|TWO_SIDED|95.0|-1.0166|-0.114|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||-0.1140|-1.0166|0.0141
91535071|NCT02926937|182948167|SUPERIORITY||Difference in LS Mean|-0.346||||0.2081|TWO_SIDED|95.0|-0.8853|0.1928|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups under Amendment 1 randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||0.1928|-0.8853|0.2081
91535072|NCT02926937|182948168|SUPERIORITY||Difference in LS Mean|-1.556|||<|0.0001|TWO_SIDED|95.0|-2.1876|-0.9234|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥ 130mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.9234|-2.1876|<0.0001
91535073|NCT02926937|182948169|SUPERIORITY||Difference in LS Mean|-3.5||||0.168|TWO_SIDED|95.0|-8.478|1.476|||ANCOVA|||The change from baseline to Week 12 is analyzed using analysis ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening and country as fixed effects, and baseline SBP as a covariate.||1.476|-8.478|0.1680
91535074|NCT02926937|182948170|SUPERIORITY||Difference in LS Mean|-0.78||||0.5467|TWO_SIDED|95.0|-3.311|1.753|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.753|-3.311|0.5467
91535075|NCT02926937|182948171|SUPERIORITY||Difference in LS Mean|-3.19||||0.0193|TWO_SIDED|95.0|-5.869|-0.518|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.518|-5.869|0.0193
91758483|NCT02684188|183410037|SUPERIORITY|||||||0.479||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.479
91758484|NCT02684188|183410037|SUPERIORITY|||||||0.329|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.329
91535076|NCT02926937|182948172|SUPERIORITY||Difference in LS Mean|-1.54||||0.0005|TWO_SIDED|95.0|-2.404|-0.676|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.676|-2.404|0.0005
91535077|NCT02926937|182948173|SUPERIORITY||Difference in LS Mean|-1.17||||0.0406|TWO_SIDED|95.0|-2.281|-0.05|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.050|-2.281|0.0406
91758485|NCT02684188|183410037|SUPERIORITY|||||||0.78|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|This Hypothesis was tested with no adjustments for covariates since none were significant.|||0.780
91535078|NCT02926937|182948174|SUPERIORITY||Percentage Difference|12.6||||0.0037|TWO_SIDED|95.0|4.18|21.02|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||21.02|4.18|0.0037
91535079|NCT02926937|182948175|SUPERIORITY||Percentage Difference|19.2||||0.0007|TWO_SIDED|95.0|8.39|30.0|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||30.00|8.39|0.0007
91535080|NCT02926937|182948176|SUPERIORITY||Difference in LS Mean|-0.67|||<|0.0001|TWO_SIDED|95.0|-0.989|-0.354|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.354|-0.989|<0.0001
91535081|NCT00126113|182948196|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
91535082|NCT00126113|182948197|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Analysis for main effect of group|ANOVA|||||||>0.05
91535083|NCT00126113|182948198|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
91758486|NCT02684188|183410037|SUPERIORITY|||||||0.779||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.779
91512655|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.46|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.46|-1.34|<0.0001
91512656|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.35|-0.48|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.48|-1.35|<0.0001
91512657|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004||95.0|-1.23|-0.35|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.35|-1.23|0.0004
91512658|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0058||95.0|-1.08|-0.18|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.18|-1.08|0.0058
91512659|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0046||95.0|-1.11|-0.2|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.20|-1.11|0.0046
91512660|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.0019||95.0|-1.18|-0.27|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.27|-1.18|0.0019
91512661|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.33|-0.44|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.44|-1.33|<0.0001
91512662|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0079||95.0|-1.04|-0.16|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.16|-1.04|0.0079
91535084|NCT00126113|182948199|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
91512663|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.0515||95.0|-0.9|0.0|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.00|-0.90|0.0515
91512664|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.23||0.1864||95.0|-0.77|0.15|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.15|-0.77|0.1864
91512665|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.24||0.2866||95.0|-0.72|0.21|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.21|-0.72|0.2866
91512666|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.11|STANDARD_ERROR_OF_MEAN|0.24||0.647||95.0|-0.58|0.36|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.36|-0.58|0.6470
91512667|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.028||95.0|-0.97|-0.06|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||-0.06|-0.97|0.0280
91512668|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.0854||95.0|-0.84|0.05|||Mixed Models Analysis|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.05|-0.84|0.0854
91512669|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1078|TWO_SIDED|95.0|-0.69|0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.07|-0.69|0.1078
91535085|NCT03499600|182948201|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on caregiver perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
91512670|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.2235||95.0|-0.62|0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.14|-0.62|0.2235
91512671|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.1369||95.0|-0.68|0.09|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.09|-0.68|0.1369
91512672|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.661||95.0|-0.48|0.31|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.31|-0.48|0.6610
91512673|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.0284||95.0|-0.81|-0.05|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||-0.05|-0.81|0.0284
91512674|NCT04666441|182896826|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.08||95.0|-0.71|0.04|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.04|-0.71|0.0800
91512675|NCT01114516|182896866|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Log Rank|||Kaplan Meier survival analysis||||0.018
91512676|NCT01114516|182896867|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|1.06|2.05||||||||2.05|1.06|
91512677|NCT01114516|182896868|SUPERIORITY_OR_OTHER|||||||0.393|TWO_SIDED||||||Kruskal-Wallis|||||||0.393
91512678|NCT01431508|182896872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||Comparison of Week 12 and Baseline||||<0.05
91512679|NCT00132769|182896873|SUPERIORITY_OR_OTHER||Difference in LS Mean|1.48||||0.278|TWO_SIDED|95.0|-1.21|4.18|||ANCOVA|||||4.18|-1.21|0.278
91512680|NCT00132769|182896874|SUPERIORITY_OR_OTHER||Difference in Percent|-5.66||||0.543|TWO_SIDED|95.0|-24.45|13.13|||Cochran-Mantel-Haenszel|||||13.13|-24.45|0.543
91512681|NCT00132769|182896881|SUPERIORITY_OR_OTHER||LS mean ratio between treatments|0.84||||0.225|TWO_SIDED|95.0|0.63|1.12|||ANCOVA|||||1.12|0.63|0.225
91512682|NCT01612546|182896891|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
91758487|NCT02684188|183410037|SUPERIORITY|||||||0.848||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.848
91512683|NCT01016834|182896896|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance||||0.0007
91512684|NCT06748040|182896932|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4852|TWO_SIDED|95.0|-2.4|1.2||P-value less than 0.05 is considered as statistically significant.|t-test, 2 sided|||||1.2|-2.4|0.4852
91512685|NCT01722331|182896939|SUPERIORITY||Difference in percentages|56.6|||<|0.001|TWO_SIDED|95.0|49.6|62.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||62.8|49.6|<0.001
91512686|NCT01722331|182896939|SUPERIORITY||Difference in percentages|58.0|||<|0.001|TWO_SIDED|95.0|51.0|64.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||64.1|51.0|<0.001
91512687|NCT01722331|182896940|SUPERIORITY||Difference in percentages|52.1|||<|0.001|TWO_SIDED|95.0|44.8|58.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||58.5|44.8|<0.001
91512688|NCT01722331|182896940|SUPERIORITY||Difference in percentages|50.9|||<|0.001|TWO_SIDED|95.0|43.6|57.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||57.4|43.6|<0.001
91512689|NCT01722331|182896944|SUPERIORITY||Difference in percentages|32.9|||<|0.001|TWO_SIDED|95.0|26.8|38.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.8|26.8|<0.001
91535086|NCT03499600|182948201|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.68|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on caregiver satisfaction with the intake.||||.68
91512690|NCT01722331|182896944|SUPERIORITY||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|25.9|38.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.0|25.9|<0.001
91512691|NCT01722331|182896945|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.2|8.3|<0.001
91512692|NCT01722331|182896945|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.0|17.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.3|8.0|<0.001
91512693|NCT01722331|182896947|OTHER||Difference in least squares means|-7.7|||<|0.001|TWO_SIDED|95.0|-8.6|-6.8|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.8|-8.6|<0.001
91512694|NCT01722331|182896947|OTHER||Difference in least squares means|-7.4|||<|0.001|TWO_SIDED|95.0|-8.3|-6.5|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.5|-8.3|<0.001
91512695|NCT01722331|182896948|OTHER||Difference in percentages|38.9|||<|0.001|TWO_SIDED|95.0|31.9|45.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||45.4|31.9|<0.001
91512696|NCT01722331|182896948|OTHER||Difference in percentages|36.1|||<|0.001|TWO_SIDED|95.0|29.3|42.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||42.5|29.3|<0.001
91512697|NCT01168999|182897027|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
91512698|NCT01168999|182897028|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||||||0.01
91512699|NCT01168999|182897029|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
91512700|NCT01168999|182897030|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
91512701|NCT01168999|182897031|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Repeated Measure ANOVA|||||||0.05
91512702|NCT01168999|182897032|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
91512703|NCT01282710|182897047|SUPERIORITY_OR_OTHER|||||||0.04627||95.0|||||Mixed Models Analysis|||"Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||.04627
91512704|NCT01282710|182897047|SUPERIORITY_OR_OTHER|||||||0.1676||95.0|||||Mixed Models Analysis|||"Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||0.1676
91512705|NCT01854554|182897048|SUPERIORITY|||||||0.74|||||||Gray's test|Cumulative Incidence Function treating progressive disease (RANO) or death before cognitive function decline as a competing risk.||||||.74
91512706|NCT01854554|182897049|SUPERIORITY|||||||0.6|||||||Log Rank|||||||.60
91512707|NCT01854554|182897050|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
91535087|NCT03499600|182948201|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on provider perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
91758488|NCT02684188|183410037|SUPERIORITY|||||||0.857||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.857
91758489|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|1097.0||||||90.0|793.6|1461.0||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||1461|793.6|
91758490|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|54.6||||||90.0|35.36|85.49||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||85.49|35.36|
91758491|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|79.81|142.0||P-Values were not calculated.|||This analysis is for Serotype 9V|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||142.0|79.81|
91512708|NCT02504645|182897052|SUPERIORITY|||||||0.2631|TWO_SIDED|0.0|||||Chi-squared|||||||0.2631
91512709|NCT00359762|182897054|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if \<1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. If CI excludes 1, the hypothesis that the risk of treatment failure with Exenatide is equal to that with Glimepiride is rejected.|Hazard Ratio|0.748||||0.002|TWO_SIDED|95.0|0.623|0.899|||Regression, Cox|Time to treatment failure was modeled using Cox regression with treatment and baseline HbA1c as predictive terms.||The null hypothesis (H0) and alternative hypothesis (H1) for the primary analysis (i.e., non-inferiority) are:H0: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \>=1.25.H1: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \< 1.25. With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.||0.899|0.623|0.0020
91512710|NCT00359762|182897055|SUPERIORITY_OR_OTHER|||||||0.0315|TWO_SIDED|99.95|||||Log Rank|||Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.||||0.0315
91512711|NCT00359762|182897056|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|5.56||0.7648|TWO_SIDED|95.0|-12.58|9.25|||Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||9.25|-12.58|0.7648
91512712|NCT00359762|182897057|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.35|STANDARD_ERROR_OF_MEAN|7.399||0.0528|TWO_SIDED|95.0|-28.88|0.17|||ANCOVA|||Change in HOMA-B from baseline to endpoint was analyzed by an analysis of covariance (ANCOVA) model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.17|-28.88|0.0528
91512713|NCT00359762|182897058|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.904|TWO_SIDED|95.0|-0.07|0.06|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.06|-0.07|0.9040
91512714|NCT00359762|182897059|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.25|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Change in fasting proinsulin/insulin ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.01|-0.05|0.2500
91512715|NCT00359762|182897060|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|4.497||0.9001|TWO_SIDED|95.0|-9.4|8.27|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||8.27|-9.40|0.9001
91512716|NCT00359762|182897061|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|11.19|STANDARD_ERROR_OF_MEAN|4.966||0.0246|TWO_SIDED|95.0|1.44|20.95|||ANCOVA|||Change in DI30/DG30 ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||20.95|1.44|0.0246
91512717|NCT00359762|182897062|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.598||0.0036|TWO_SIDED|95.0|1.53|7.81|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||7.81|1.53|0.0036
91758492|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|134.3||||||90.0|80.83|197.1||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||197.1|80.83|
91758493|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|200.3||||||90.0|151.9|302.4||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||302.4|151.9|
91758494|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|181.3||||||90.0|119.8|253.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||253.1|119.8|
91535088|NCT03499600|182948201|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.|||||<|0.05|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on provider satisfaction with the intake.||||<.05
91758495|NCT00488826|183410038|SUPERIORITY_OR_OTHER||Geometric mean ratio|90.02||||||90.0|57.93|150.5||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||150.5|57.93|
91758496|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|665.1||||||90.0|473.3|851.2||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||851.2|473.3|
91758497|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|22.2||||||90.0|13.99|31.77||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||31.77|13.99|
91758498|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|73.7||||||90.0|56.41|103.6||P-Values were not calculated.|||This analysis is for Serotype 9V.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||103.6|56.41|
91512718|NCT00359762|182897063|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.33|STANDARD_ERROR_OF_MEAN|2.128||0.0006|TWO_SIDED|95.0|3.15|11.5|||ANCOVA|||Change in disposition index from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||11.50|3.15|0.0006
91512719|NCT00359762|182897064|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0128|TWO_SIDED|95.0|-0.31|-0.04|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.04|-0.31|0.0128
91512720|NCT00359762|182897065|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0015|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.||-0.06|-0.26|0.0015
91512721|NCT00359762|182897066|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.174|<|0.0001|TWO_SIDED|95.0|-1.03|-0.34|||Mixed Models Analysis|||MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.34|-1.03|<.0001
91512722|NCT00359762|182897067|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.183||0.0109|TWO_SIDED|95.0|-0.83|-0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-0.11|-0.83|0.0109
91512723|NCT00359762|182897068|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.424|<|0.0001|TWO_SIDED|95.0|-3.64|-1.97|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-1.97|-3.64|<.0001
91512724|NCT00359762|182897069|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.327|<|0.0001|TWO_SIDED|95.0|-2.84|-1.55|||ANCOVA|||Change in postprandial (2 hours) plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-1.55|-2.84|<.0001
91512725|NCT00359762|182897070|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|0.463|<|0.0001|TWO_SIDED|95.0|-6.31|-4.49|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.||-4.49|-6.31|<.0001
91512726|NCT00359762|182897071|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|1.228|<|0.0001|TWO_SIDED|95.0|-7.61|-2.79|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-2.79|-7.61|<.0001
91512727|NCT00359762|182897072|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.75||0.0228|TWO_SIDED|95.0|-3.18|-0.24|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.24|-3.18|0.0228
91512728|NCT00359762|182897073|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.805||0.3737|TWO_SIDED|95.0|-2.3|0.86|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.86|-2.30|0.3737
91512729|NCT00359762|182897074|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.089||0.0042|TWO_SIDED|95.0|-0.43|-0.08|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.08|-0.43|0.0042
91512730|NCT00359762|182897075|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.079||0.7914|TWO_SIDED|95.0|-0.13|0.18|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.18|-0.13|0.7914
91512731|NCT00359762|182897076|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.019||0.0011|TWO_SIDED|95.0|0.02|0.1|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.10|0.02|0.0011
91758499|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|61.09|147.5||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||147.5|61.09|
91535089|NCT03499600|182948203|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.93|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on therapeutic alliance.||||.93
91535090|NCT03499600|182948203|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Tested the moderation effects of language of service reception and condition on therapeutic alliance.||||.90
91535091|NCT03499600|182948204|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery. Baseline ECBI score was included as a covariate for the treatment response analyses.||||||0.171|||||||Regression, Logistic|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A logistic regression tested condition effects on treatment response.||||.171
91535092|NCT03499600|182948204|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Testes the effects of the moderation of language of service delivery and condition on treatment response.||||<.05
91535093|NCT03499600|182948205|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.38|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on session attendance.||||.38
91758500|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|164.0||||||90.0|114.9|232.9||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||232.9|114.9|
91512732|NCT00359762|182897077|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.22|0.37|||Negative Binomial Model|||The number of hypoglycemic episodes by patient were compared between treatment groups using a negative binomial model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||0.37|0.22|<.0001
91512733|NCT00359762|182897078|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.141||0.0508|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.||0.55|-0.00|0.0508
91512734|NCT02819726|182897081|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|95.33|||||TWO_SIDED|90.0|87.07|104.37||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||104.37|87.07|
91535094|NCT03499600|182948205|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Analyses tested the moderation of language of service delivery and condition on session attendance.||||.01
91535095|NCT03499600|182948205|SUPERIORITY|||||||0.56|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on homework completion. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.56
91535096|NCT03499600|182948205|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analyses tested the moderation effect of language of service delivery and condition on homework completion.||||<.01
91512735|NCT02819726|182897081|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|93.43|||||TWO_SIDED|90.0|85.54|102.15||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.15|85.54|
91512736|NCT02819726|182897081|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.06|||||TWO_SIDED|90.0|89.49|107.45||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||107.45|89.49|
91535097|NCT03499600|182948205|SUPERIORITY|||||||0.4|||||||Regression, Logistic|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Logistic regressions tested condition effects on initial session attendance. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.40
91535098|NCT03499600|182948205|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on initial session attendance.||||.01
91758501|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.45||||||90.0|57.98|119.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||119.1|57.98|
91758502|NCT00488826|183410039|SUPERIORITY_OR_OTHER||Geometric mean ratio|44.7||||||90.0|29.48|68.71||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||68.71|29.48|
91758503|NCT00422383|183410080|SUPERIORITY_OR_OTHER||Weighted Difference|-0.01||||0.8156|TWO_SIDED|95.0|-0.13|0.1|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.|||0.10|-0.13|0.8156
91512737|NCT02819726|182897082|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.07|||||TWO_SIDED|90.0|86.91|101.81||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.81|86.91|
91512738|NCT02819726|182897082|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|94.39|||||TWO_SIDED|90.0|87.21|102.16||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.16|87.21|
91512739|NCT02819726|182897082|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|100.35|||||TWO_SIDED|90.0|92.68|108.65||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||108.65|92.68|
91512740|NCT02819726|182897083|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|96.31|||||TWO_SIDED|90.0|90.52|102.46||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.46|90.52|
91512741|NCT02819726|182897083|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.65|||||TWO_SIDED|90.0|92.64|105.05||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.05|92.64|
91512742|NCT02819726|182897083|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.43|||||TWO_SIDED|90.0|96.14|109.14||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||109.14|96.14|
91512743|NCT02819726|182897084|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.93|||||TWO_SIDED|90.0|89.03|101.23||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.23|89.03|
91535099|NCT03499600|182948205|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A Logistic regression tested condition effects on completion of first treatment module. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.03
91512744|NCT02819726|182897084|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.75|||||TWO_SIDED|90.0|92.61|105.3||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.30|92.61|
91512745|NCT02819726|182897084|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|104.03|||||TWO_SIDED|90.0|97.54|110.95||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||110.95|97.54|
91512746|NCT02819726|182897085|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|89.08|||||TWO_SIDED|90.0|77.2|102.79||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.79|77.20|
91512747|NCT02819726|182897085|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.56|||||TWO_SIDED|90.0|88.72|118.56||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||118.56|88.72|
91512748|NCT02819726|182897085|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|115.13|||||TWO_SIDED|90.0|99.51|133.21||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||133.21|99.51|
91512749|NCT02819726|182897086|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.134||0.2402|TWO_SIDED|95.0|-0.422|0.106|||ANCOVA|||Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.106|-0.422|0.2402
91512750|NCT02819726|182897086|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.135||0.1346|TWO_SIDED|95.0|-0.469|0.063|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.063|-0.469|0.1346
91512751|NCT02819726|182897086|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7429|TWO_SIDED|95.0|-0.314|0.224|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.224|-0.314|0.7429
91512752|NCT02819726|182897095|OTHER||LS Means Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.172||0.6068|TWO_SIDED|95.0|-0.428|0.25|||ANCOVA|||Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.250|-0.428|0.6068
91512753|NCT02819726|182897095|OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.172||0.599|TWO_SIDED|95.0|-0.249|0.43|||ANCOVA|||Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.249|0.5990
91512754|NCT02819726|182897095|OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.175||0.3053|TWO_SIDED|95.0|-0.165|0.532|||ANCOVA|||Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.532|-0.165|0.3053
91512755|NCT02819726|182897096|OTHER||Difference (%)|9.4|STANDARD_ERROR_OF_MEAN|7.22|||TWO_SIDED|95.0|-4.74|23.03||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||23.03|-4.74|
91512756|NCT02819726|182897096|OTHER||Difference (%)|-2.5|STANDARD_ERROR_OF_MEAN|7.05|||TWO_SIDED|95.0|-15.95|11.22||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||11.22|-15.95|
91512757|NCT02819726|182897096|OTHER||Difference (%)|-11.8|STANDARD_ERROR_OF_MEAN|7.26|||TWO_SIDED|95.0|-25.47|2.45||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||2.45|-25.47|
91512758|NCT02819726|182897097|OTHER||Difference (%)|9.5|STANDARD_ERROR_OF_MEAN|6.87|||TWO_SIDED|95.0|-4.07|22.46||||||ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||22.46|-4.07|
91512759|NCT02819726|182897097|OTHER||Difference (%)|3.5|STANDARD_ERROR_OF_MEAN|7.07|||TWO_SIDED|95.0|-10.22|17.03||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.03|-10.22|
91512760|NCT02819726|182897097|OTHER||Difference (%)|-5.9|STANDARD_ERROR_OF_MEAN|6.88|||TWO_SIDED|95.0|-19.1|7.51||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||7.51|-19.10|
91512761|NCT02819726|182897097|OTHER||Difference (%)|10.0|STANDARD_ERROR_OF_MEAN|5.78|||TWO_SIDED|95.0|-1.52|21.22||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||21.22|-1.52|
91535100|NCT03499600|182948205|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on completion of first treatment module.||||.03
91535101|NCT03499600|182948206|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.854|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on treatment satisfaction.||||.854
91535102|NCT03499600|182948207|SUPERIORITY|||||||0.319|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested change in ECBI score from baseline to post treatment.||||.319
91535103|NCT00561574|182948214|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535104|NCT00561574|182948214|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535105|NCT00561574|182948215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535106|NCT00561574|182948215|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535107|NCT00561574|182948216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535108|NCT00561574|182948216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535109|NCT00561574|182948217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3129||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3129
91535110|NCT00561574|182948217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3154||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3154
91535111|NCT00561574|182948218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535112|NCT00561574|182948218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535113|NCT00561574|182948219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535114|NCT00561574|182948219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535115|NCT00561574|182948220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
91535116|NCT00561574|182948220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0001
91535117|NCT00561574|182948221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0116
91535118|NCT00561574|182948221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0004
91535119|NCT03860077|182948236|SUPERIORITY|Average cigarettes per day was positively skewed, with a non-normal residual distribution in a mixed model analysis specifying a normal (Gaussian) outcome distribution. Therefore, this outcome was recoded to integers and modeled as a count with a negative binomial distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Risk Ratio (RR)|1.42|STANDARD_ERROR_OF_MEAN|0.21||0.111|TWO_SIDED|95.0|0.92|2.19|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = 0.35.|These are results of a 2-group (VLNC \& NNC) x 2 repeated measures (Baseline \& Week 4) mixed effects model to test the effect of the randomization group (VLNC vs. NNC) on change in cigarette use and alternative tobacco product (ATP) use from Baseline to Week 4. Group (VLNC vs. NNC) is a fixed, between-subjects focal predictor. Timepoint (Baseline vs. Week 4) is a fixed, within-subjects repeated measure. Subject is a random effect, accounting for variability in Baseline cigarette and ATP use.||2.19|0.92|.111
91535120|NCT03860077|182948237|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.93||0.721|TWO_SIDED|95.0|0.11|4.75|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.34.|This outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.||4.75|.11|.721
91758504|NCT00422383|183410080|SUPERIORITY_OR_OTHER||Weighted Difference|0.07||||0.2419|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, RF status, and treatment.|||0.19|-0.05|0.2419
91535121|NCT03860077|182948238|SUPERIORITY|Frequencies of non-combustible alternative product use (ATP) were bimodal with peaks at 0 (no use) and 7 (daily use). Therefore, this outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Odds Ratio (OR)|0.57|STANDARD_ERROR_OF_MEAN|0.96||0.564|TWO_SIDED|95.0|0.08|3.99|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.56.|||3.99|.08|.564
91535122|NCT03860077|182948239|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|1.56||0.876|TWO_SIDED|95.0|-2.92|3.42|||Mixed Models Analysis|||The study cigarette outcome is modeled with a normal, Gaussian distribution. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group. Baseline in this analysis is average number of usual brand cigarettes at baseline, prior to randomization.||3.42|-2.92|.876
91535123|NCT03860077|182948240|SUPERIORITY|The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Slope|-2166.79|STANDARD_ERROR_OF_MEAN|1753.48||0.226|TWO_SIDED|95.0|-5743.04|1409.47|||Mixed Models Analysis|||||1409.47|-5743.04|.226
91535124|NCT01140347|182948298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.1391|TWO_SIDED|95.0|0.717|1.046|||Log Rank||HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).|||1.046|0.717|0.1391
91758505|NCT00422383|183410083|SUPERIORITY_OR_OTHER|||||||0.7127|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.7127
91758506|NCT00422383|183410083|SUPERIORITY_OR_OTHER|||||||0.1018|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.1018
91512762|NCT02819726|182897097|OTHER||Difference|5.4|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-6.69|17.13||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.13|-6.69|
91512763|NCT02819726|182897097|OTHER||Difference (%)|-4.7|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|92.0|-15.68|6.41||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||6.41|-15.68|
91512764|NCT02819726|182897098|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.991||0.1997|TWO_SIDED|95.0|-3.23|0.671|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.671|-3.230|0.1997
91512765|NCT02819726|182897098|OTHER||LS Means Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.996||0.9098|TWO_SIDED|95.0|-2.074|1.848|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||1.848|-2.074|0.9098
91512766|NCT02819726|182897098|OTHER||LS Means Difference|1.17|STANDARD_ERROR_OF_MEAN|1.008||0.248|TWO_SIDED|95.0|-0.817|3.15|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||3.150|-0.817|0.2480
91512767|NCT02819726|182897098|OTHER||LS Means Difference|-1.96|STANDARD_ERROR_OF_MEAN|1.5||0.1931|TWO_SIDED|95.0|-4.909|0.996|||ANCOVA|||Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.996|-4.909|0.1931
91512768|NCT02819726|182897098|OTHER||LS Means Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.5||-0.77|TWO_SIDED|95.0|-3.722|2.184|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||2.184|-3.722|-0.77
91535125|NCT01140347|182948299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.625|||<|0.0001|TWO_SIDED|95.0|0.522|0.75|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.750|0.522|<0.0001
91512769|NCT02819726|182897098|OTHER||LS Means Difference|1.19|STANDARD_ERROR_OF_MEAN|1.52||0.4352|TWO_SIDED|95.0|-1.805|4.18|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||4.180|-1.805|0.4352
91512770|NCT02819726|182897099|OTHER||LS Means Difference|-4.16|STANDARD_ERROR_OF_MEAN|3.242||0.2008|TWO_SIDED|95.0|-10.541|2.226|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||2.226|-10.541|0.2008
91512771|NCT02819726|182897099|OTHER||LS Means Difference|-0.39|STANDARD_ERROR_OF_MEAN|3.242||-0.39|TWO_SIDED|95.0|-6.771|5.994|||ANOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||5.994|-6.771|-0.39
91535126|NCT01140347|182948300|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease||||||<0.0001
91535127|NCT01140347|182948301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.487|0.722|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.722|0.487|<0.0001
91512772|NCT02819726|182897099|OTHER||LS Means Difference|3.77|STANDARD_ERROR_OF_MEAN|3.268||0.2498|TWO_SIDED|95.0|-2.665|10.204|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||10.204|-2.665|0.2498
91512773|NCT02819726|182897100|OTHER||LS Means Difference|-1.23|STANDARD_ERROR_OF_MEAN|3.592||0.7322|TWO_SIDED|95.0|-8.0302|5.841|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.841|-8.0302|0.7322
91512774|NCT02819726|182897100|OTHER||LS Means Difference|-2.21|STANDARD_ERROR_OF_MEAN|3.623||0.5418|TWO_SIDED|95.0|-9.347|4.92|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||4.920|-9.347|0.5418
91512775|NCT02819726|182897100|OTHER||LS Means Difference|-0.98|STANDARD_ERROR_OF_MEAN|3.633||0.7869|TWO_SIDED|95.0|-8.136|6.169|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||6.169|-8.136|0.7869
91512776|NCT02819726|182897101|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|3.443||0.7097|TWO_SIDED|95.0|-8.062|5.496|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.496|-8.062|0.7097
91535128|NCT03107611|182948360|SUPERIORITY|||||||0.0817|||||||Fisher Exact|||||||0.0817
91535129|NCT03107611|182948360|SUPERIORITY|||||||0.2874|||||||Fisher Exact|||||||0.2874
91758507|NCT00422383|183410084|SUPERIORITY_OR_OTHER|||||||0.5029|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.5029
91758508|NCT00422383|183410084|SUPERIORITY_OR_OTHER|||||||0.0495|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.0495
91758509|NCT00238238|183410122|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
91758510|NCT00238238|183410123|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
91758511|NCT01007838|183410124|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was accepted if p \< 0.05.|ANCOVA|||Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controls||||0.30
91758512|NCT01007838|183410124|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Statistical significance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.0017
91758513|NCT01007838|183410124|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Statistical sigficance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.024
91758514|NCT04978818|183410126|NON_INFERIORITY|The anti-PRP IgG GMC for children receiving dose 1 of Vaxelis® was defined a priori as non-inferior if it was within a 1.5-fold margin of the GMC for children receiving dose 1 of PedvaxHIB®, corresponding to the lower bound of the 95% confidence interval (CI) of the IgG GMC ratio (Vaxelis® to PedvaxHIB®) being greater than 0.67.|Ratio of Geometric Mean Concentration|1.03||||0.85|TWO_SIDED|95.0|0.75|1.41|||Constrained Longitudinal Analysis||The lower bound of the 95% confidence interval was greater than the pre-specified non-inferiority margin of 0.67. Thus, Vaxelis® post-dose 1 anti-PRP IgG immunogenicity met the non-inferiority criterion compared to PedvaxHIB®.|||1.41|0.75|0.85
91758515|NCT04978818|183410127|OTHER|||||||0.39|||||||Chi-squared|||||||0.39
91512777|NCT02819726|182897101|OTHER||LS Means Difference|-1.48|STANDARD_ERROR_OF_MEAN|3.453||0.6683|TWO_SIDED|95.0|-8.28|5.317|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.317|-8.280|0.6683
91512778|NCT02819726|182897101|OTHER||LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.494||0.9548|TWO_SIDED|95.0|-7.078|6.682|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||6.682|-7.078|0.9548
91512779|NCT02819726|182897102|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.0505|TWO_SIDED|95.0|-0.339|0.0|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.000|-0.339|0.0505
91512780|NCT02819726|182897102|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.1141|TWO_SIDED|95.0|-0.307|0.033|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.033|-0.307|0.1141
91512781|NCT02819726|182897102|OTHER||LS Means Difference|0.03|STANDARD_ERROR_OF_MEAN|0.087||0.7111|TWO_SIDED|95.0|-0.139|0.204|||ANCOVA|||Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.204|-0.139|0.7111
91512782|NCT02819726|182897103|OTHER||LS Means Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.871||0.8183|TWO_SIDED|95.0|-4.113|3.253|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||3.253|-4.113|0.8183
91512783|NCT02819726|182897103|OTHER||LS Means Difference|1.51|STANDARD_ERROR_OF_MEAN|1.868||0.4186|TWO_SIDED|95.0|-2.164|5.191|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.191|-2.164|0.4186
91512784|NCT02819726|182897103|OTHER||LS Means Difference|1.94|STANDARD_ERROR_OF_MEAN|1.885||0.3035|TWO_SIDED|95.0|-1.768|5.655|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.655|-1.768|0.3035
91512785|NCT02819726|182897104|OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9249|TWO_SIDED|95.0|-0.375|0.413|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.413|-0.375|0.9249
91512786|NCT02819726|182897104|OTHER||LS Measn Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.05|TWO_SIDED|95.0|-0.351|0.442|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.442|-0.351|0.05
91512787|NCT02819726|182897104|OTHER||LS Means Diference|0.03|STANDARD_ERROR_OF_MEAN|0.205||0.8962|TWO_SIDED|95.0|-0.376|0.43|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.376|0.8962
91512788|NCT02819726|182897105|OTHER||Difference (%)|2.2|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-2.56|7.83||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||7.83|-2.56|
91512789|NCT02819726|182897105|OTHER||Difference (%)|1.0|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-4.74|6.67||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||6.67|-4.74|
91512790|NCT02819726|182897105|OTHER||Difference (%)|-1.3|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-6.75|3.39||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.39|-6.75|
91512791|NCT02819726|182897106|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-6.9|3.9||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.90|-6.9|
91512792|NCT02819726|182897106|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-7.07|3.86||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.86|-7.07|
91512793|NCT02819726|182897106|OTHER||Differnce (%)|-0.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-6.05|5.83||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||5.83|-6.05|
91512794|NCT02819726|182897107|OTHER||Difference (%)|1.3|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|95.0|-12.59|15.1||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||15.10|-12.59|
91512795|NCT02819726|182897107|OTHER||Difference (%)|0.2|STANDARD_ERROR_OF_MEAN|7.21|||TWO_SIDED|95.0|-13.75|14.03|||Difference (%)|||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||14.03|-13.75|
91512796|NCT02819726|182897107|OTHER||Difference (%)|-1.1|STANDARD_ERROR_OF_MEAN|7.29|||TWO_SIDED|95.0|-15.14|12.91||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||12.91|-15.14|
91512797|NCT02819726|182897113|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|22.1|||||TWO_SIDED|90.0|-137.1|181.3||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||181.3|-137.1|
91512798|NCT02819726|182897113|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|69.5|||||TWO_SIDED|90.0|-91.8|230.8||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||230.8|-91.8|
91512799|NCT02819726|182897113|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|47.4|||||TWO_SIDED|90.0|-112.5|207.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||207.2|-112.5|
91512800|NCT02819726|182897113|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|310.7|||||TWO_SIDED|90.0|-187.9|809.4||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||809.4|-187.9|
91535130|NCT03107611|182948361|EQUIVALENCE|Equivalence margin: -0.20, +0.20|Difference in proportions|-0.03|||||TWO_SIDED|90.0|-0.12|0.06||||||||0.06|-0.12|
91758516|NCT04978818|183410128|OTHER|||||||0.64|||||||Chi-squared|||||||0.64
91512801|NCT02819726|182897113|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|296.1|||||TWO_SIDED|90.0|-213.8|806.1||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||806.1|-213.8|
91512802|NCT02819726|182897113|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|-14.6|||||TWO_SIDED|90.0|-527.4|498.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||498.2|-527.4|
91512803|NCT02461589|182897132|OTHER||Treatment difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.77|||Mixed Models Analysis|||||-0.77|-1.30|<0.0001
91512804|NCT02461589|182897132|OTHER||Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.08|||Mixed Models Analysis|||||-1.08|-1.61|<0.0001
91512805|NCT02461589|182897132|OTHER||Treatment difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.95|-1.42|||Mixed Models Analysis|||||-1.42|-1.95|<0.0001
91512806|NCT02461589|182897132|OTHER||Treatment difference|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.12|-1.6|||Mixed Models Analysis|||||-1.60|-2.12|<0.0001
91512807|NCT01978119|182897137|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by capsule-based unit dose DPI versus FSC administered BID by multi-dose DPI is greater than -125 milliliter (mL).|Mean Difference (Net)|0.028|||||TWO_SIDED|95.0|-0.024|0.08|||Repeated Measures Mixed Models|||||0.080|-0.024|
91512808|NCT01978119|182897138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.039|0.334||||||||0.334|-1.039|
91512809|NCT01978119|182897139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||||TWO_SIDED|95.0|-0.372|0.927||||||||0.927|-0.372|
91512810|NCT01978119|182897140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|||||TWO_SIDED|95.0|-0.074|0.088|||||Day 28 Change from Baseline Analysis|||0.088|-0.074|
91758517|NCT04978818|183410129|OTHER|||||||0.87|||||||Chi-squared|||||||0.87
91758518|NCT04978818|183410130|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
91758519|NCT04978818|183410131|OTHER|||||||0.15|||||||Chi-squared|||||||0.15
91758520|NCT04978818|183410132|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
91535131|NCT01720446|182948364|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR \<1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).|Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.|Regression, Cox||Semaglutide/Placebo|The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio \[HR\] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.||0.95|0.58|<0.0001
91535132|NCT01720446|182948364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0167|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of no difference.|Regression, Cox||Semaglutide/Placebo|A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.95|0.58|0.0167
91535133|NCT01720446|182948365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0016|TWO_SIDED|95.0|0.62|0.89|||Regression, Cox||Semaglutide/Placebo|Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.89|0.62|0.0016
91535134|NCT01720446|182948366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9181|TWO_SIDED|95.0|0.65|1.48|||Regression, Cox||Semaglutide/Placebo|Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.48|0.65|0.9181
91535135|NCT01720446|182948366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1194|TWO_SIDED|95.0|0.51|1.08|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.08|0.51|0.1194
91758521|NCT01345669|183410138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.126||||0.4806|TWO_SIDED|95.0|0.809|1.569|||Log Rank||Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.||1.569|0.809|0.4806
91512811|NCT01978119|182897140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022||||||95.0|-0.049|0.092|||||Day 56 Change from Baseline Analysis|||0.092|-0.049|
91512812|NCT01978119|182897141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.35|||||TWO_SIDED|95.0|-1.34|10.05||||||||10.05|-1.34|
91512813|NCT01978119|182897142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09||||||||0.09|-0.20|
91512814|NCT01978119|182897144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.25|||||TWO_SIDED|95.0|-6.97|2.46||||||||2.46|-6.97|
91512815|NCT01978119|182897145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||||0.5|-0.9|
91512816|NCT01978119|182897146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.64|3.11||||||||3.11|-4.64|
91512817|NCT01958918|182897204|SUPERIORITY|||||||0.185|||||||ANOVA|||||||0.1850
91512818|NCT00659269|182897235|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
91512819|NCT00908960|182897237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.7||||0.06|TWO_SIDED|95.0|1.03|43.17|||Fine and Gray regression|||||43.17|1.03|0.06
91512820|NCT02401672|182897241|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91512821|NCT02401672|182897242|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91512822|NCT02401672|182897243|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91512823|NCT02401672|182897244|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91512824|NCT01736852|182897246|NON_INFERIORITY|non-inferiority margin of 10%, α = 0.025, power = 0.80,||||||0.06|||||||Fisher Exact|||.ample size calculations were performed using an expected rate of 4% for each group,a one-sided exact test, α = 0.025, power = 0.80, non-inferiority margin of 10% resulting in a sample size of 124 patients or 62 patients per treatment arm.||||0.06
91512825|NCT00403546|182897252|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.09|1.12|||Mixed Models Analysis|||At Baseline||1.12|-1.09|0.980
91512826|NCT00403546|182897252|SUPERIORITY||Mean Difference (Net)|1.02||||0.033|TWO_SIDED|95.0|0.08|1.95|||Mixed Models Analysis|||At Week 2||1.95|0.08|0.033
91512827|NCT00403546|182897252|SUPERIORITY||Mean Difference (Net)|0.73||||0.171|TWO_SIDED|95.0|-0.32|1.77|||Mixed Models Analysis|||At Week 4||1.77|-0.32|0.171
91512828|NCT00403546|182897252|SUPERIORITY||Mean Difference (Net)|0.5||||0.38|TWO_SIDED|95.0|-0.62|1.62|||Mixed Models Analysis|||At Week 6||1.62|-0.62|0.380
91512829|NCT00403546|182897252|SUPERIORITY||Mean Difference (Net)|-0.12||||0.84|TWO_SIDED|95.0|-1.32|1.08|||Mixed Models Analysis|||At Week 8||1.08|-1.32|0.840
91512830|NCT00403546|182897253|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.737|TWO_SIDED|95.0|-1.23|0.88|||Mixed Models Analysis|||At Baseline||0.88|-1.23|0.737
91512831|NCT00403546|182897253|SUPERIORITY||Mean Difference (Net)|-0.14||||0.764|TWO_SIDED|95.0|-1.09|0.8|||Mixed Models Analysis|||At Week 2||0.80|-1.09|0.764
91512832|NCT00403546|182897253|SUPERIORITY||Mean Difference (Net)|0.25||||0.642|TWO_SIDED|95.0|-0.82|1.32|||Mixed Models Analysis|||At Week 4||1.32|-0.82|0.642
91512833|NCT00403546|182897253|SUPERIORITY||Mean Difference (Net)|-0.34||||0.57|TWO_SIDED|95.0|-1.5|0.83|||Mixed Models Analysis|||At Week 6||0.83|-1.50|0.570
91512834|NCT00403546|182897253|SUPERIORITY||Mean Difference (Net)|-0.09||||0.894|TWO_SIDED|95.0|-1.34|1.17|||Mixed Models Analysis|||At Week 8||1.17|-1.34|0.894
91512835|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|-1.82||||0.599|TWO_SIDED|95.0|-8.68|5.05|||Mixed Models Analysis|||SBP at Baseline||5.05|-8.68|0.599
91758522|NCT01345669|183410139|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimates|-6.27||||0.161|TWO_SIDED|95.0|-15.04|2.5|||Log Rank||Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.|Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated||2.50|-15.04|0.1610
91758523|NCT01345669|183410140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.444||||0.1301|TWO_SIDED|95.0|0.895|2.332||p-value (two-sided) from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.332|0.895|0.1301
91512836|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|3.53||||0.235|TWO_SIDED|95.0|-2.31|9.37|||Mixed Models Analysis|||SBP at Week 1||9.37|-2.31|0.235
91512837|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|2.83||||0.449|TWO_SIDED|95.0|-3.8|8.57|||Mixed Models Analysis|||SBP at Week 2||8.57|-3.80|0.449
91512838|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|3.64||||0.301|TWO_SIDED|95.0|-3.28|10.56|||Mixed Models Analysis|||SBP at Week 4||10.56|-3.28|0.301
91512839|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|-0.75||||0.842|TWO_SIDED|95.0|-8.13|6.63|||Mixed Models Analysis|||SBP at Week 6||6.63|-8.13|0.842
91512840|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|6.33||||0.109|TWO_SIDED|95.0|-1.43|14.09|||Mixed Models Analysis|||SBP at Week 8||14.09|-1.43|0.109
91512841|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|-0.8||||0.741|TWO_SIDED|95.0|-5.62|4.02|||Mixed Models Analysis|||DBP at Baseline||4.02|-5.62|0.741
91512842|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|1.44||||0.552|TWO_SIDED|95.0|-3.32|6.19|||Mixed Models Analysis|||DBP at Week 1||6.19|-3.32|0.552
91512843|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|2.83||||0.268|TWO_SIDED|95.0|-2.18|7.84|||Mixed Models Analysis|||DBP at Week 2||7.84|-2.18|0.268
91512844|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|1.02||||0.719|TWO_SIDED|95.0|-4.53|6.56|||Mixed Models Analysis|||DBP at Week 4||6.56|-4.53|0.719
91512845|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|-2.86||||0.334|TWO_SIDED|95.0|-8.68|2.96|||Mixed Models Analysis|||DBP at Week 6||2.96|-8.68|0.334
91512846|NCT00403546|182897255|SUPERIORITY||Mean Difference (Net)|4.38||||0.151|TWO_SIDED|95.0|-1.61|10.37|||Mixed Models Analysis|||DBP at Week 8||10.37|-1.61|0.151
91535136|NCT01720446|182948366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0438|TWO_SIDED|95.0|0.38|0.99|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.99|0.38|0.0438
91535137|NCT01720446|182948366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0027|TWO_SIDED|95.0|0.5|0.86|||Regression, Cox||Semaglutide/Placebo|Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.86|0.50|0.0027
91758524|NCT01345669|183410141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.431||||0.0561|TWO_SIDED|95.0|0.991|2.068|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Swallowing (Q5-Q8 from QLQ-HN35).||2.068|0.991|0.0561
91512847|NCT00403546|182897257|SUPERIORITY||Mean Difference (Final Values)|2.77||||0.416|TWO_SIDED|95.0|-3.97|9.5|||Mixed Models Analysis|Mixed models analysis with random slopes||At Baseline||9.50|-3.97|0.416
91512848|NCT00403546|182897257|SUPERIORITY||Mean Difference (Net)|0.37||||0.854|TWO_SIDED|95.0|-3.59|4.33|||Mixed Models Analysis|||At Week 2||4.33|-3.59|0.854
91512849|NCT00403546|182897257|SUPERIORITY||Mean Difference (Net)|1.95||||0.406|TWO_SIDED|95.0|-2.68|6.58|||Mixed Models Analysis|||At Week 4||6.58|-2.68|0.406
91512850|NCT00403546|182897257|SUPERIORITY||Mean Difference (Net)|-3.01||||0.256|TWO_SIDED|95.0|-8.23|2.21|||Mixed Models Analysis|||At Week 6||2.21|-8.23|0.256
91512851|NCT00403546|182897257|SUPERIORITY||Mean Difference (Net)|-1.37||||0.642|TWO_SIDED|95.0|-7.2|4.45|||Mixed Models Analysis|||At Week 8||4.45|-7.20|0.642
91512852|NCT00403546|182897259|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.135|TWO_SIDED|95.0|-1.55|0.2|||Mixed Models Analysis|||At Baseline||0.20|-1.55|0.135
91512853|NCT00403546|182897259|SUPERIORITY||Mean Difference (Net)|0.44||||0.262|TWO_SIDED|95.0|-0.33|1.21|||Mixed Models Analysis|||At Week 2||1.21|-0.33|0.262
91512854|NCT00403546|182897259|SUPERIORITY||Mean Difference (Net)|0.58||||0.209|TWO_SIDED|95.0|-0.33|1.49|||Mixed Models Analysis|||At Week 4||1.49|-0.33|0.209
91512855|NCT00403546|182897259|SUPERIORITY||Mean Difference (Net)|0.03||||0.95|TWO_SIDED|95.0|-1.01|1.07|||Mixed Models Analysis|||At Week 6||1.07|-1.01|0.950
91512856|NCT00403546|182897259|SUPERIORITY||Mean Difference (Net)|0.57||||0.34|TWO_SIDED|95.0|-0.61|1.76|||Mixed Models Analysis|||At Week 8||1.76|-0.61|0.340
91512857|NCT01168934|182897277|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|43.44|||||TWO_SIDED|90.0|39.68|47.56||||||Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||47.56|39.68|
91512858|NCT01168934|182897280|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|44.67|||||TWO_SIDED|90.0|40.9|48.78||||||Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||48.78|40.90|
91512859|NCT01070810|182897295|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
91758525|NCT01345669|183410141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446||||0.0523|TWO_SIDED|95.0|0.996|2.098|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Pain HN35 (Q1-Q4 from QLQ-HN35).||2.098|0.996|0.0523
91535138|NCT01720446|182948366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4914|TWO_SIDED|95.0|0.47|1.44|||Regression, Cox||Semaglutide/Placebo|Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.44|0.47|0.4914
91535139|NCT01720446|182948366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5735|TWO_SIDED|95.0|0.77|1.61|||Regression, Cox||Semaglutide/Placcbo|Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.61|0.77|0.5735
91535140|NCT01720446|182948367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0292|TWO_SIDED|95.0|0.61|0.97|||Regression, Cox||Semaglutide/Placebo|Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.97|0.61|0.0292
91535141|NCT01720446|182948368|SUPERIORITY_OR_OTHER||Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.52|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.52|-0.80|<0.0001
91535142|NCT01720446|182948368|SUPERIORITY_OR_OTHER||Treatment difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.91|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.91|-1.19|<0.0001
91535143|NCT01720446|182948369|SUPERIORITY_OR_OTHER||Treatment difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.38|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.38|-1.06|<0.0001
91758526|NCT01345669|183410141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.257|TWO_SIDED|95.0|0.577|1.158|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Global health status/QoL(Q29-Q30 from QLQ-C30).||1.158|0.577|0.2570
91758527|NCT01345669|183410142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.295||||0.0591|TWO_SIDED|95.0|0.986|1.7||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.700|0.986|0.0591
91512860|NCT01070810|182897296|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.97|TWO_SIDED|95.0|0.61|1.62|||Regression, Cox|||Time to shock reversal was complicated by a high incidence of death prior to the event. To account for this we classified death as a competing risk event and used the estimated cumulative incidence function (CIF) to illustrate the comparison of CIFs between the two treatment groups using the Fine-Gray competing risk model. We tested the subdistribution hazards of these two CIF functions and obtained the estimated hazard ratio with 95% confidence intervals.||1.62|0.61|0.97
91512861|NCT01070810|182897297|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91512862|NCT01070810|182897298|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91512863|NCT01070810|182897299|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
91512864|NCT05061446|182897305|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
91512865|NCT05061446|182897305|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
91512866|NCT05061446|182897306|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
91512867|NCT05061446|182897306|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
91512868|NCT05061446|182897307|OTHER||Difference in percentage|20.0|||||TWO_SIDED|95.0|-0.24|40.24||||||||40.24|-0.24|
91512869|NCT05061446|182897307|OTHER||Difference in percentage|31.6|||||TWO_SIDED|95.0|10.68|52.48||||||||52.48|10.68|
91512870|NCT05061446|182897308|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
91512871|NCT05061446|182897308|OTHER||Difference in percentage|5.3|||||TWO_SIDED|95.0|-4.78|15.3||||||||15.30|-4.78|
91512872|NCT05061446|182897309|OTHER||Difference in percentage|26.2|||||TWO_SIDED|95.0|-1.22|53.6||||||||53.60|-1.22|
91512873|NCT05061446|182897309|OTHER||Difference in percentage|45.5|||||TWO_SIDED|95.0|19.3|71.68||||||||71.68|19.30|
91512874|NCT02799082|182897344|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"The percentages stated relate to the total number of subjects for the respective week and treatment.~Cochran-Mantel-Haenszel Test stratified by center"|Cochran-Mantel-Haenszel|||||||<0.0001
91512875|NCT02799082|182897345|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91512876|NCT02799082|182897353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91512877|NCT02799082|182897354|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91512878|NCT02442700|182897395|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91512879|NCT00752908|182897404|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91512880|NCT02610140|182897409|SUPERIORITY||Hazard Ratio (HR)|1.215||||0.859125|TWO_SIDED|95.0|0.85|||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.|Log Rank||Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.|PFS anetumab ravtansine / vinorelbine||1,738|0.850|0.859125
91512881|NCT02610140|182897410|SUPERIORITY||Hazard Ratio (HR)|1.072||||0.655624|TWO_SIDED|95.0|0.763|1.506||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.|Log Rank||Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.|OS anetumab ravtansine / vinorelbine||1.506|0.763|0.655624
91512882|NCT02610140|182897415|SUPERIORITY||Difference (%) improvement rate symptoms|4.65||||0.244|TWO_SIDED|95.0|-8.2|17.51|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||Anetumab ravtansine versus vinorelbine||17.51|-8.20|0.244
91512883|NCT02610140|182897416|SUPERIORITY||Hazard Ratio (HR)|0.829||||0.313747|TWO_SIDED|95.0|0.386|1.779|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.779|0.386|0.313747
91512884|NCT02610140|182897417|SUPERIORITY||Hazard Ratio (HR)|0.924||||0.378916|TWO_SIDED|95.0|0.557|1.533|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.533|0.557|0.378916
91512885|NCT02610140|182897418|SUPERIORITY||Difference (%) improvement rate of pain|6.64||||0.214|TWO_SIDED|95.0|-9.4|22.68|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||||22.68|-9.40|0.214
91512886|NCT02610140|182897421|SUPERIORITY||Mean Difference (Final Values)|9.5|||||TWO_SIDED|95.0|0.1|39.3||||||||39.3|0.1|
91512887|NCT02610140|182897421|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|0.0|35.9||||||||35.9|0.0|
91512888|NCT00887341|182897422|SUPERIORITY_OR_OTHER|||||||0.238|||||||Chi-squared|||||||0.238
91512889|NCT00887341|182897429|SUPERIORITY_OR_OTHER|||||||0.121|||||||Chi-squared|||Week 4||||0.121
91512890|NCT00887341|182897429|SUPERIORITY_OR_OTHER|||||||0.809|||||||Chi-squared|||Week 8||||0.809
91512891|NCT00887341|182897429|SUPERIORITY_OR_OTHER|||||||0.367|||||||Chi-squared|||Week 12||||0.367
91512892|NCT00887341|182897429|SUPERIORITY_OR_OTHER|||||||0.339|||||||Chi-squared|||Week 16||||0.339
91512893|NCT00887341|182897429|SUPERIORITY_OR_OTHER|||||||0.017|||||||Chi-squared|||Week 20||||0.017
91512894|NCT00887341|182897429|SUPERIORITY_OR_OTHER|||||||0.451|||||||Chi-squared|||Final visit||||0.451
91512895|NCT00887341|182897430|SUPERIORITY_OR_OTHER|||||||0.377|||||||Chi-squared|||Week 4||||0.377
91512896|NCT00887341|182897430|SUPERIORITY_OR_OTHER|||||||0.387|||||||Chi-squared|||Week 8||||0.387
91512897|NCT00887341|182897430|SUPERIORITY_OR_OTHER|||||||0.304|||||||Chi-squared|||Week 12||||0.304
91512898|NCT00887341|182897430|SUPERIORITY_OR_OTHER|||||||0.509|||||||Chi-squared|||Week 16||||0.509
91512899|NCT00887341|182897430|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Week 20||||0.110
91512900|NCT00887341|182897430|SUPERIORITY_OR_OTHER|||||||0.504|||||||Chi-squared|||Final visit||||0.504
91512901|NCT00887341|182897431|SUPERIORITY_OR_OTHER|||||||0.327|||||||Chi-squared|||Week 4||||0.327
91512902|NCT00887341|182897431|SUPERIORITY_OR_OTHER|||||||0.786|||||||Chi-squared|||Week 8||||0.786
91512903|NCT00887341|182897431|SUPERIORITY_OR_OTHER|||||||0.482|||||||Chi-squared|||Week 12||||0.482
91535144|NCT01720446|182948369|SUPERIORITY_OR_OTHER||Treatment difference|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.56|-0.88|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.88|-1.56|<0.0001
91512904|NCT00887341|182897431|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||Week 16||||0.680
91512905|NCT00887341|182897431|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Week 20||||0.690
91512906|NCT00887341|182897431|SUPERIORITY_OR_OTHER|||||||0.516|||||||Chi-squared|||Final Visit||||0.516
91512907|NCT00887341|182897432|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||Week 8||||0.970
91512908|NCT00887341|182897432|SUPERIORITY_OR_OTHER|||||||0.587|||||||Chi-squared|||Week 12||||0.587
91512909|NCT00887341|182897432|SUPERIORITY_OR_OTHER|||||||0.184|||||||Chi-squared|||Week 16||||0.184
91512910|NCT00887341|182897432|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||Week 20||||0.600
91512911|NCT00887341|182897432|SUPERIORITY_OR_OTHER|||||||0.937|||||||Chi-squared|||Final Visit||||0.937
91512912|NCT01591681|182897447|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.||||<0.001
91512913|NCT01591681|182897448|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||<0.001
91512914|NCT01591681|182897449|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
91512915|NCT01591681|182897450|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
91512916|NCT01591681|182897451|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
91512917|NCT01591681|182897452|SUPERIORITY_OR_OTHER|||||||0.71||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.71
91512918|NCT01591681|182897453|SUPERIORITY_OR_OTHER|||||||0.62||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.62
91512919|NCT01591681|182897454|SUPERIORITY_OR_OTHER|||||||0.1||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.10
91512920|NCT01591681|182897455|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
91512921|NCT01591681|182897456|SUPERIORITY_OR_OTHER|||||||0.98||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.98
91512922|NCT01591681|182897457|SUPERIORITY_OR_OTHER|||||||0.93||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.93
91512923|NCT01306617|182897475|SUPERIORITY_OR_OTHER|||||||0.547|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.||||0.547
91512924|NCT01306617|182897475|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.207
91512925|NCT01306617|182897476|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
91758528|NCT01345669|183410142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.456||||0.0049|TWO_SIDED|95.0|1.113|1.905||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.905|1.113|0.0049
91758529|NCT01345669|183410142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.604||||0.0002|TWO_SIDED|95.0|1.238|2.079||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.079|1.238|0.0002
91758530|NCT01345669|183410143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.2232|TWO_SIDED|95.0|-0.81|3.45|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||3.45|-0.81|0.2232
91758531|NCT01345669|183410143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.08||0.0028|TWO_SIDED|95.0|1.12|5.36|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||5.36|1.12|0.0028
91758532|NCT01345669|183410143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.98||0.0005|TWO_SIDED|95.0|-5.33|-1.49|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||-1.49|-5.33|0.0005
91512926|NCT01306617|182897477|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
91512927|NCT01306617|182897477|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.375
91512928|NCT01306617|182897478|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
91512929|NCT01306617|182897478|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
91512930|NCT01306617|182897479|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
91512931|NCT01306617|182897479|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
91512932|NCT01306617|182897480|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Log Rank|||||||0.395
91512933|NCT01306617|182897480|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Log Rank|||||||0.010
91512934|NCT01306617|182897481|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Log Rank|||||||0.048
91512935|NCT01208233|182897493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.4962|TWO_SIDED|80.0|0.41|1.31|||Regression, Logistic|LOCF was used to impute missing data.||||1.31|0.41|0.4962
91512936|NCT01208233|182897493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.2517|TWO_SIDED|80.0|0.29|1.07|||Regression, Logistic|The analysis was based on OC.||||1.07|0.29|0.2517
91512937|NCT01208233|182897494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.942||0.9716|TWO_SIDED|80.0|-4.972|5.254|||Mixed Models Analysis|||Paretic hand||5.254|-4.972|0.9716
91758533|NCT01793883|183410159|SUPERIORITY|||||||0.251|||||||Log Rank|||||||0.251
91758534|NCT01793883|183410159|SUPERIORITY|||||||0.818|||||||Log Rank|||||||0.818
91758535|NCT03738618|183410175|OTHER||Treatment difference|43.3|||<|0.001|TWO_SIDED|95.0|36.5|47.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||47.6|36.5|<0.001
91758536|NCT03738618|183410176|OTHER||Treatment difference|22.0|||<|0.001|TWO_SIDED|95.0|14.9|25.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||25.7|14.9|<0.001
91512938|NCT01208233|182897495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.789|STANDARD_ERROR_OF_MEAN|7.2392||0.1417|TWO_SIDED|80.0|1.401|20.177|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||20.177|1.401|0.1417
91512939|NCT01208233|182897496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.33|STANDARD_ERROR_OF_MEAN|5.4241||0.0611|TWO_SIDED|80.0|-17.351|-3.31|||Mixed Models Analysis|||Paretic hand||-3.310|-17.351|0.0611
91512940|NCT01208233|182897496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|3.2899||0.9433|TWO_SIDED|80.0|-4.011|4.48|||Mixed Models Analysis|||Non-paretic hand||4.480|-4.011|0.9433
91512941|NCT01208233|182897497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.812|STANDARD_ERROR_OF_MEAN|6.8448||0.0654|TWO_SIDED|80.0|-21.668|-3.957|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||-3.957|-21.668|0.0654
91512942|NCT01208233|182897498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.951|TWO_SIDED|80.0|0.54|1.76|||Regression, Logistic|||LOCF was used to impute missing data.||1.76|0.54|0.9510
91512943|NCT01208233|182897499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.854||||0.7234|TWO_SIDED|80.0|0.48|1.51|||Regression, Logistic|||LOCF was used to impute missing data.||1.51|0.48|0.7234
91512944|NCT01208233|182897500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.283|STANDARD_ERROR_OF_MEAN|0.6755||0.6759|TWO_SIDED|80.0|-1.156|0.589|||Mixed Models Analysis|||||0.589|-1.156|0.6759
91535145|NCT01720446|182948370|SUPERIORITY_OR_OTHER||Treatment difference|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.47|-2.44|||Mixed Models Analysis||Sema 0.5 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-2.44|-3.47|<0.0001
91758537|NCT03738618|183410180|OTHER||Treatment difference|26.8|||<|0.001|TWO_SIDED|95.0|19.8|30.8|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||30.8|19.8|<0.001
91758538|NCT03738618|183410180|OTHER||Treatment difference|52.0|||<|0.001|TWO_SIDED|95.0|44.9|56.3|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||56.3|44.9|<0.001
91758539|NCT03738618|183410181|OTHER||Treatment difference|23.5|||<|0.001|TWO_SIDED|95.0|16.7|27.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||27.2|16.7|<0.001
91758540|NCT03738618|183410181|OTHER||Treatment difference|45.6|||<|0.001|TWO_SIDED|95.0|38.5|49.9|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||49.9|38.5|<0.001
91512945|NCT01208233|182897501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.433||||0.4213|TWO_SIDED|80.0|0.81|2.54|||Regression, Logistic|||BI \>=95, LOCF was used to impute missing data.||2.54|0.81|0.4213
91512946|NCT01208233|182897501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.651||||0.276|TWO_SIDED|80.0|0.92|2.98|||Regression, Logistic|||BI=100, LOCF was used to impute missing data.||2.98|0.92|0.2760
91512947|NCT01208233|182897502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.599|STANDARD_ERROR_OF_MEAN|4.4547||0.2118|TWO_SIDED|80.0|-0.15|11.348|||Mixed Models Analysis|||||11.348|-0.150|0.2118
91512948|NCT01208233|182897503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.062|STANDARD_ERROR_OF_MEAN|1.7844||0.5541|TWO_SIDED|80.0|-1.252|3.375|||Mixed Models Analysis|||||3.375|-1.252|0.5541
91512949|NCT01208233|182897504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.4178||0.426|TWO_SIDED|80.0|-0.874|0.205|||Mixed Models Analysis|||||0.205|-0.874|0.4260
91512950|NCT01208233|182897505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.477|STANDARD_ERROR_OF_MEAN|5.4394||0.65|TWO_SIDED|80.0|-4.547|9.5|||Mixed Models Analysis|||(L+R)/28 × 100%||9.500|-4.547|0.6500
91512951|NCT01208233|182897505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.874|STANDARD_ERROR_OF_MEAN|6.7431||0.5671|TWO_SIDED|80.0|-4.834|12.583|||Mixed Models Analysis|||(L/14) × 100%||12.583|-4.834|0.5671
91512952|NCT01208233|182897505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.049|STANDARD_ERROR_OF_MEAN|5.2816||0.843|TWO_SIDED|80.0|-5.771|7.87|||Mixed Models Analysis|||(R/14) × 100%||7.870|-5.771|0.8430
91512953|NCT01208233|182897506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.0733||0.1512|TWO_SIDED|80.0|0.011|0.201|||Mixed Models Analysis|||(L R)/(L+R)||0.201|0.011|0.1512
91512954|NCT01208233|182897507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.279|STANDARD_ERROR_OF_MEAN|0.5041||0.0128|TWO_SIDED|80.0|-1.929|-0.629|||Mixed Models Analysis|||||-0.629|-1.929|0.0128
91512955|NCT01208233|182897508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.1226||0.4713|TWO_SIDED|80.0|-0.07|0.248|||Mixed Models Analysis|||||0.248|-0.070|0.4713
91512956|NCT01208233|182897515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|2.7201||0.8501|TWO_SIDED|80.0|-4.026|2.995|||Mixed Models Analysis|||Non-paretic hand||2.995|-4.026|0.8501
91512957|NCT01891734|182897525|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91512958|NCT01891734|182897526|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91512959|NCT04028388|182897527|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.1465|TWO_SIDED|95.0|0.56|2.65|||Wilcoxon (Mann-Whitney)|||||2.65|0.56|0.1465
91512960|NCT04028388|182897531|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.4576|TWO_SIDED|95.0|0.39|7.93|||Log Rank|||DOR is calculated in the subpopulation of subjects experiencing a response (CR or PR). Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome.||7.93|0.39|0.4576
91758541|NCT03738618|183410183|OTHER||Treatment difference|32.1|||<|0.001|TWO_SIDED|95.0|24.9|36.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||36.2|24.9|<0.001
91758542|NCT03738618|183410183|OTHER||Treatment difference|58.9|||<|0.001|TWO_SIDED|95.0|51.9|63.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||63.0|51.9|<0.001
91758543|NCT03738618|183410195|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91758544|NCT03738618|183410196|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91758545|NCT03738618|183410197|OTHER|||||||0.19|||||||Fisher Exact|||||||0.190
91758546|NCT03738618|183410198|OTHER|||||||0.396|||||||Fisher Exact|||||||0.396
91535146|NCT01720446|182948370|SUPERIORITY_OR_OTHER||Treatment difference|-4.27|||<|0.0001|TWO_SIDED|95.0|-4.78|-3.75|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-3.75|-4.78|<0.0001
91535147|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.0149|TWO_SIDED|95.0|0.95|1.0|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.00|0.95|0.0149
91535148|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.258|TWO_SIDED|95.0|0.97|1.01|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.01|0.97|0.2580
91535149|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.8106|TWO_SIDED|95.0|0.99|1.02|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.02|0.99|0.8106
91535150|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|1.04|||<|0.0001|TWO_SIDED|95.0|1.02|1.06|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.06|1.02|<0.0001
91535151|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|0.96||||0.0185|TWO_SIDED|95.0|0.93|0.99|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.99|0.93|0.0185
91535152|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.5996|TWO_SIDED|95.0|0.96|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|0.96|0.5996
91535153|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.1833|TWO_SIDED|95.0|0.93|1.01|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.01|0.93|0.1833
91535154|NCT01720446|182948371|SUPERIORITY_OR_OTHER||Treatment ratio|0.93||||0.0009|TWO_SIDED|95.0|0.89|0.97|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.97|0.89|0.0009
91535155|NCT01720446|182948372|SUPERIORITY_OR_OTHER||Treatment ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89|||Mixed Models Analysis||Sema 0.5 mg / Placebo 0.5 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||0.89|0.68|0.0003
91535156|NCT01720446|182948372|SUPERIORITY_OR_OTHER||Treatment ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Mixed Models Analysis||Sema 1.0 mg / Placebo 1.0 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.81|0.62|<0.0001
91758547|NCT01959139|183410307|SUPERIORITY||Hazard Ratio (HR)|2.07|||<|0.01|TWO_SIDED|95.0|1.28|3.34|||Regression, Cox|||||3.34|1.28|<0.01
91535157|NCT01720446|182948373|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9205|TWO_SIDED|95.0|-0.83|0.92|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.92|-0.83|0.9205
91535158|NCT01720446|182948373|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.7477|TWO_SIDED|95.0|-0.74|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|-0.74|0.7477
91758548|NCT01959139|183410308|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66|||Regression, Cox|||||2.66|1.14|0.01
91758549|NCT02255461|183410335|OTHER|Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
91758550|NCT02255461|183410336|OTHER|Ordinal logistic regression model was built for outcome lymphopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
91535159|NCT01720446|182948373|SUPERIORITY_OR_OTHER||Treatment difference|-1.27||||0.0976|TWO_SIDED|95.0|-2.77|0.23|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.23|-2.77|0.0976
91758551|NCT02255461|183410337|OTHER|Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.01|1.2||||||||1.20|1.01|
91758552|NCT01963845|183410347|SUPERIORITY_OR_OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
91758553|NCT01963845|183410348|SUPERIORITY_OR_OTHER|||||||0.7583|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in AST values from baseline to 24 weeks between the two groups.||||0.7583
91758554|NCT01963845|183410349|SUPERIORITY_OR_OTHER|||||||0.8569|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in ALT values from baseline to 24 weeks between the two groups.||||0.8569
91535160|NCT01720446|182948373|SUPERIORITY_OR_OTHER||Treatment difference|-2.59||||0.0008|TWO_SIDED|95.0|-4.09|-1.08|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-1.08|-4.09|0.0008
91535161|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.3171|TWO_SIDED|95.0|-0.48|1.47|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.47|-0.48|0.3171
91535162|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.47||||0.0031|TWO_SIDED|95.0|0.5|2.45|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.45|0.50|0.0031
91535163|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.87||||0.035|TWO_SIDED|95.0|0.06|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|0.06|0.0350
91535164|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.42||||0.0007|TWO_SIDED|95.0|0.6|2.24|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.24|0.60|0.0007
91535165|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.7277|TWO_SIDED|95.0|-0.79|1.13|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.13|-0.79|0.7277
91535166|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.97||||0.0489|TWO_SIDED|95.0|0.0|1.94|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.94|0.00|0.0489
91535167|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment Difference|0.61||||0.186|TWO_SIDED|95.0|-0.3|1.53|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.53|-0.30|0.1860
91535168|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.39||||0.0029|TWO_SIDED|95.0|0.48|2.31|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.31|0.48|0.0029
91535169|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.68||||0.0833|TWO_SIDED|95.0|-0.09|1.45|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.45|-0.09|0.0833
91535170|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.4||||0.0004|TWO_SIDED|95.0|0.62|2.17|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.17|0.62|0.0004
91535171|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.8||||0.0799|TWO_SIDED|95.0|-0.1|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|-0.10|0.0799
91758555|NCT01963845|183410350|SUPERIORITY_OR_OTHER|||||||0.7984|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in LDL values from baseline to 24 weeks between the two groups.||||0.7984
91535172|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.5||||0.0011|TWO_SIDED|95.0|0.6|2.4|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.40|0.60|0.0011
91535173|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.53||||0.3717|TWO_SIDED|95.0|-0.63|1.68|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.68|-0.63|0.3717
91535174|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.94||||0.1136|TWO_SIDED|95.0|-0.22|2.1|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.10|-0.22|0.1136
91535175|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.72||||0.1431|TWO_SIDED|95.0|-0.24|1.67|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.67|-0.24|0.1431
91758556|NCT01963845|183410351|SUPERIORITY_OR_OTHER|||||||0.556|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.||||0.5560
91759940|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.09|||||TWO_SIDED|95.0|-13.5|1.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.32|-13.50|
91512961|NCT04028388|182897532|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0776|TWO_SIDED|95.0|0.65|3.48|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome"||3.48|0.65|0.0776
91512962|NCT04028388|182897534|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.2539|TWO_SIDED|95.0|0.79|2.49|||Log Rank|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.49|0.79|0.2539
91512963|NCT04028388|182897535|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.3062|TWO_SIDED|95.0|0.76|2.42|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.42|0.76|0.3062
91512964|NCT00129259|182897554|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).||"Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.~Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values."||||0.002
91512965|NCT00129259|182897555|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||ANCOVA|ANCOVA adjusts for baseline HbA1c.||"Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.~Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups."||||0.697
91512966|NCT00129259|182897556|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|ANCOVA adjusts for baseline daily insulin use per kg||"Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.~Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups."||||0.110
91512967|NCT00139997|182897581|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
91512968|NCT00019682|182897590|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
91512969|NCT00019682|182897591|SUPERIORITY|||||||0.008||||||Unadjusted 2 tail p value.|Log Rank|||||||0.008
91512970|NCT00019682|182897592|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91512971|NCT00019682|182897593|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-G scale||||>0.05
91512972|NCT00019682|182897593|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-F scale||||>0.05
91512973|NCT00019682|182897593|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SF-36 scale||||>0.05
91512974|NCT00019682|182897593|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SDS scale||||>0.05
91512975|NCT01543256|182897616|NON_INFERIORITY|Non-Inferiority margin was 20%||||||0.008|||||||Exact non-inferiority|||||||.008
91759941|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-20.46|-5.65||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.65|-20.46|
91512976|NCT01543256|182897617|SUPERIORITY|||||||0.568|||||||Fisher Exact|||||||.568
91512977|NCT01543256|182897618|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
91512978|NCT01543256|182897619|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||.99
91512979|NCT01543256|182897620|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||.519
91512980|NCT01543256|182897621|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
91512981|NCT00822510|182897622|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
91512982|NCT00822510|182897624|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|0.79|||||ANOVA|||||||.79
91512983|NCT00822510|182897625|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
91512984|NCT00822510|182897626|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
91512985|NCT00822510|182897627|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|0.71|||||ANOVA|||||||.71
91512986|NCT00822510|182897628|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.01|||||ANOVA|||||||.01
91512987|NCT00116805|182897633|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 160 subjects in the TDF group and 80 subjects in the ADV group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the TDF treatment was inferior to the ADV treatment (the difference in proportions was less than -0.080) in favor of the alternative hypothesis that the TDF treatment was not inferior.|Difference in proportions|54.1|STANDARD_ERROR_OF_MEAN|4.8|<|0.001|TWO_SIDED|95.0|44.6|63.6||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≤ 4 x upper limit of the normal range \[ULN\] or \> 4 x ULN) difference is 0.|Z-test|2-sided 95% confidence interval (CI), stratified by baseline ALT was used to evaluate difference between groups in proportion of complete responders.||||63.6|44.6|<0.001
91512988|NCT00116805|182897634|SUPERIORITY_OR_OTHER||Difference in proportions|63.1|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|53.8|72.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero.|Z-test|Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||||72.3|53.8|<0.001
91512989|NCT00116805|182897635|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4|STANDARD_ERROR_OF_MEAN|5.4||0.801|TWO_SIDED|95.0|-12.0|9.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero.|Z-test|Two-sided 95% CIs, stratified by baseline ALT (baseline ALT ≤ 4 x ULN or \> 4 x ULN), were used to evaluate treatment group differences.||||9.3|-12.0|0.801
91759942|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.31|||||TWO_SIDED|95.0|-22.69|-7.93||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.93|-22.69|
91535176|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0197|TWO_SIDED|95.0|0.18|2.11|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.11|0.18|0.0197
91535177|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|-0.05||||0.9223|TWO_SIDED|95.0|-1.03|0.93|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.93|-1.03|0.9223
91535178|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0237|TWO_SIDED|95.0|0.15|2.13|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.13|0.15|0.0237
91535179|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.4523|TWO_SIDED|95.0|-0.53|1.19|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.19|-0.53|0.4523
91535180|NCT01720446|182948377|SUPERIORITY_OR_OTHER||Treatment difference|1.2||||0.0064|TWO_SIDED|95.0|0.34|2.07|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.07|0.34|0.0064
91535181|NCT01720446|182948378|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.7796|TWO_SIDED|95.0|0.95|1.04|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.04|0.95|0.7796
91535182|NCT01720446|182948378|SUPERIORITY_OR_OTHER||Treatment ratio|0.92||||0.0003|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.96|0.88|0.0003
91535183|NCT01720446|182948379|SUPERIORITY_OR_OTHER||Treatment difference|2.02|||<|0.0001|TWO_SIDED|95.0|1.07|2.98|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.98|1.07|<0.0001
91535184|NCT01720446|182948379|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.0001|TWO_SIDED|95.0|1.52|3.43|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||3.43|1.52|<0.0001
91535185|NCT01020838|182948394|SUPERIORITY_OR_OTHER||Sensitivity|0.774|||||TWO_SIDED|95.0|0.654|0.894|||||Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.~The following hypothesis was formulated for sensitivity:~H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity \> 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6"||0.894|0.654|
91535186|NCT01020838|182948394|SUPERIORITY_OR_OTHER||Specificity|0.942|||||TWO_SIDED|95.0|0.886|0.998|||||Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.~The following hypothesis was formulated for specificity:~H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity \> 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8"||0.998|0.886|
91758557|NCT01357551|183410352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|0.78||0.04|TWO_SIDED|95.0|0.07|3.13||A priori threshold was p\<.05|Mixed Models Analysis|Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point||The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.||3.13|.07|.04
91758558|NCT01357551|183410353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.49|STANDARD_ERROR_OF_MEAN|78.64||0.11|TWO_SIDED|95.0|-280.71|29.72|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction||The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.||29.72|-280.71|.11
91535187|NCT02145182|182948404|SUPERIORITY||Odds Ratio (OR)|0.81||||0.3983|TWO_SIDED|95.0|0.49|1.33|||Regression, Logistic|Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.|Calculated using the logistic regression model.|Analysis of DGF composite||1.33|0.49|0.3983
91535188|NCT00742274|182948435|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91535189|NCT01101165|182948436|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|96.6|||||TWO_SIDED|90.0|92.8|100.56|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||100.56|92.80|
91535190|NCT01101165|182948437|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.8|||||TWO_SIDED|90.0|92.42|97.24|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.24|92.42|
91535191|NCT01101165|182948438|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.5|||||TWO_SIDED|90.0|92.93|98.18|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||98.18|92.93|
91535192|NCT03124108|182948453|SUPERIORITY||Difference in percentage|-52.0|STANDARD_ERROR_OF_MEAN|5.4|<|0.001|TWO_SIDED|95.0|-62.5|-41.5|||ANCOVA|||||-41.5|-62.5|<0.001
91535193|NCT03124108|182948453|SUPERIORITY||Difference in percentage|-43.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-55.7|-32.1|||ANCOVA|||||-32.1|-55.7|<0.001
91535194|NCT01219855|182948506|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Z-test cmpared 2 independ. proportions|||||||<0.0001
91535195|NCT01219855|182948507|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
91535196|NCT01219855|182948508|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
91535197|NCT01219855|182948508|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
91535198|NCT01219855|182948509|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
91535199|NCT01219855|182948510|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Z-test compared 2 independ. proportions|||||||<0.05
91535200|NCT01219855|182948511|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Z-test compared 2 independ. proportions|||The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.||||<0.001
91535201|NCT01335932|182948583|OTHER|||||||0.0001|||||||Fisher Exact|||||||.0001
91758559|NCT01357551|183410354|SUPERIORITY_OR_OTHER||incidence rate ratio|1.03|STANDARD_ERROR_OF_MEAN|0.26||0.91|TWO_SIDED|95.0|0.63|1.68|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.||1.68|0.63|.91
91535202|NCT01335932|182948584|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
91535203|NCT01335932|182948590|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
91535204|NCT01335932|182948591|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
91535205|NCT01335932|182948592|OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
91535206|NCT01335932|182948593|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
91759943|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.31|||||TWO_SIDED|95.0|-20.66|-5.96||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.96|-20.66|
91512990|NCT00116805|182897640|SUPERIORITY_OR_OTHER||Difference in proportions|5.8|STANDARD_ERROR_OF_MEAN|5.8||0.32|TWO_SIDED|95.0|-5.6|17.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||||17.2|-5.6|0.320
91512991|NCT00116805|182897646|SUPERIORITY_OR_OTHER||Difference in proportions|13.6|STANDARD_ERROR_OF_MEAN|6.4||0.032|TWO_SIDED|95.0|1.1|26.1||P-value corresponds to a Z-test. Statistical tests were not adjusted for baseline ALT stratum.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||26.1|1.1|0.032
91512992|NCT00116805|182897647|SUPERIORITY_OR_OTHER||Difference in proportions|-9.8|STANDARD_ERROR_OF_MEAN|6.0||0.1|TWO_SIDED|95.0|-21.5|1.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||1.9|-21.5|0.100
91512993|NCT00116805|182897652|SUPERIORITY_OR_OTHER||Difference in proportions|6.1|STANDARD_ERROR_OF_MEAN|5.3||0.245|TWO_SIDED|95.0|-4.2|16.4||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||16.4|-4.2|0.245
91512994|NCT00116805|182897652|SUPERIORITY_OR_OTHER||Difference in proportions|4.7|STANDARD_ERROR_OF_MEAN|5.2||0.363|TWO_SIDED|95.0|-5.5|14.9||P-value for HBeAg seroconversion corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg seroconversion.||14.9|-5.5|0.363
91512995|NCT00116805|182897653|SUPERIORITY_OR_OTHER||Difference in proportions|0.3|STANDARD_ERROR_OF_MEAN|5.9||0.963|TWO_SIDED|95.0|-11.3|11.9||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||11.9|-11.3|0.963
91512996|NCT00116805|182897653|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|STANDARD_ERROR_OF_MEAN|5.6||0.904|TWO_SIDED|95.0|-10.4|11.7||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \>4 x ULN).||This information pertains to seroconversion to anti-HBe.||11.7|-10.4|0.904
91512997|NCT00116805|182897654|SUPERIORITY_OR_OTHER||Difference in proportions|10.9|STANDARD_ERROR_OF_MEAN|4.6||0.018|TWO_SIDED|95.0|1.9|19.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||19.9|1.9|0.018
91535207|NCT01335932|182948594|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
91535208|NCT01335932|182948595|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91535209|NCT01335932|182948596|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
91535210|NCT01335932|182948597|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
91535211|NCT01335932|182948598|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
91535212|NCT01335932|182948599|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
91535213|NCT01335932|182948600|OTHER|||||||0.63|||||||t-test, 2 sided|||||||0.63
91535214|NCT01335932|182948601|OTHER|||||||0.51|||||||t-test, 2 sided|||||||0.51
91535215|NCT01335932|182948602|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
91535216|NCT01335932|182948603|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
91535217|NCT01335932|182948604|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
91535218|NCT01335932|182948605|OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
91535219|NCT01335932|182948606|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
91758560|NCT01357551|183410355|SUPERIORITY_OR_OTHER||incidence rate ratio|1.07|STANDARD_ERROR_OF_MEAN|0.35||0.83|TWO_SIDED|95.0|0.57|2.03|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.||2.03|0.57|.83
91535220|NCT01335932|182948607|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
91535221|NCT01335932|182948608|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
91535222|NCT01335932|182948609|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
91535223|NCT01335932|182948610|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
91535224|NCT01335932|182948611|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
91758561|NCT06292130|183410360|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91535225|NCT01335932|182948612|OTHER|||||||0.8|||||||t-test, 2 sided|||||||0.80
91535226|NCT01335932|182948613|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
91535227|NCT01335932|182948614|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
91535228|NCT01335932|182948615|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
91535229|NCT00952718|182948649|SUPERIORITY|||||||0.005||||||p-value for MIP was adjusted by linear regression model.|Regression, Linear|||||||0.005
91535230|NCT00952718|182948649|SUPERIORITY|||||||0.038||||||adjusted p for MEP by linear regression|Regression, Linear|||||||0.038
91535231|NCT00952718|182948650|SUPERIORITY|||||||0.063|||||||Regression, Linear|||||||0.063
91535232|NCT00952718|182948651|SUPERIORITY|||||||0.269|||||||Regression, Linear|||||||0.269
91758562|NCT06292130|183410361|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
91758563|NCT00118742|183410367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0012||95.0|14.8|35.0|||ANCOVA|||||35.0|14.8|0.0012
91535233|NCT03582956|182948652|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
91535234|NCT03582956|182948653|SUPERIORITY|||||||0.607|||||||t-test, 2 sided|||||||0.607
91535235|NCT03582956|182948654|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||0.466
91535236|NCT03582956|182948655|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
91535237|NCT00517933|182948670|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
91535238|NCT00517933|182948672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.11|TWO_SIDED|95.0|-3.9|37.3|||Regression, Linear|||||37.3|-3.9|0.11
91535239|NCT00517933|182948673|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Log Rank|||||||0.41
91535240|NCT00517933|182948674|SUPERIORITY_OR_OTHER||Slope|-6.58|STANDARD_ERROR_OF_MEAN|2.3||0.006|TWO_SIDED|95.0|-11.25|-1.92|||Mixed Models Analysis|||||-1.92|-11.25|0.006
91535241|NCT00517933|182948676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7|TWO_SIDED|95.0|-0.05|0.07|||Mixed Models Analysis|||||0.07|-0.05|0.70
91535242|NCT00517933|182948678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.04|TWO_SIDED|95.0|0.1|3.0|||Mixed Models Analysis|||||3.0|0.1|0.04
91535243|NCT00517933|182948680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.16|TWO_SIDED|95.0|-0.81|0.14|||Regression, Linear|||||0.14|-0.81|0.16
91535244|NCT00517933|182948682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.01|TWO_SIDED|95.0|-7.3|-0.9|||Regression, Linear|||||-0.9|-7.3|0.01
91535245|NCT00517933|182948684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.02|TWO_SIDED|95.0|-10.6|-0.9|||Regression, Linear|||||-0.9|-10.6|0.02
91535246|NCT00517933|182948686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.04|TWO_SIDED|95.0|-7.2|-0.1|||Regression, Linear|||||-0.1|-7.2|0.04
91535247|NCT00517933|182948688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.07|TWO_SIDED|95.0|-7.8|0.4|||Regression, Logistic|||||0.4|-7.8|0.07
91535248|NCT00517933|182948690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||||0.06|-0.01|0.18
91535249|NCT00517933|182948692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.37|TWO_SIDED|95.0|-2.8|7.3|||Regression, Linear|||||7.3|-2.8|0.37
91535250|NCT00517933|182948696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.008|TWO_SIDED|95.0|0.8|5.0|||Regression, Linear|||||5.0|0.8|0.008
91535251|NCT00517933|182948698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.86|TWO_SIDED|95.0|-2.1|1.7|||Regression, Linear|||||1.7|-2.1|0.86
91535252|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|2.282||||0.002|TWO_SIDED|95.0|1.344|3.875|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||3.875|1.344|0.002
91535253|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84|||<|0.05|TWO_SIDED|95.0|1.621|4.977|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||4.977|1.621|<0.05
91758564|NCT00118742|183410368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|||<|0.0001||95.0|15.7|35.6|||ANCOVA|||||35.6|15.7|<0.0001
91758565|NCT00118742|183410369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.7||||0.0053||95.0|13.7|43.7|||ANCOVA|||||43.7|13.7|0.0053
91758566|NCT00118742|183410370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|21.1|||<|0.0001||95.0|12.5|29.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 6 months posttransplant||29.6|12.5|<0.0001
91758567|NCT00118742|183410370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.2|||<|0.0001||95.0|9.9|26.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 12 months posttransplant||26.6|9.9|<0.0001
91535254|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.871||||0.005|TWO_SIDED|95.0|1.207|2.899|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.899|1.207|0.005
91535255|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.879||||0.004|TWO_SIDED|95.0|1.227|2.879|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.879|1.227|0.004
91535256|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.943||||0.008|TWO_SIDED|95.0|1.191|3.168|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||3.168|1.191|0.008
91535257|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.459||||0.001|TWO_SIDED|95.0|1.454|4.159|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||4.159|1.454|0.001
91535258|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.776||||0.004|TWO_SIDED|95.0|1.199|2.631|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.631|1.199|0.004
91535259|NCT01078246|182948700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.274|2.717|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.717|1.274|0.001
91758568|NCT00118742|183410370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.6||||0.0006||95.0|10.2|37.0|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 24 months posttransplant||37.0|10.2|0.0006
91758569|NCT00183625|183410408|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
91535260|NCT01078246|182948701|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.807||||0.255|TWO_SIDED|95.0|0.557|1.168|||Poisson regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.168|0.557|0.255
91535261|NCT01078246|182948701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.646|TWO_SIDED|95.0|0.597|1.376|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.376|0.597|0.646
91535262|NCT01078246|182948701|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.268||||0.182|TWO_SIDED|95.0|0.895|1.795|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.795|0.895|0.182
91535263|NCT01078246|182948701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.257||||0.188|TWO_SIDED|95.0|0.894|1.768|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.768|0.894|0.188
91535264|NCT01078246|182948702|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.016||||0.897|TWO_SIDED|95.0|0.796|1.297|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.297|0.796|0.897
91535265|NCT01078246|182948702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.287||||0.07|TWO_SIDED|95.0|0.98|1.69|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.690|0.980|0.070
91535266|NCT01078246|182948702|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.067||||0.575|TWO_SIDED|95.0|0.85|1.339|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.339|0.850|0.575
91535267|NCT01078246|182948702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.626|TWO_SIDED|95.0|0.847|1.319|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.319|0.847|0.626
91535268|NCT01078246|182948704|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.389|||<|0.0001|TWO_SIDED|95.0|0.274|0.551|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.551|0.274|<0.0001
91758570|NCT00183625|183410409|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||The p-value listed is for the medication by time interaction.|Mixed Models Analysis|||Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.||||.0176
91535269|NCT01078246|182948704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.471|||<|0.05|TWO_SIDED|95.0|0.314|0.707|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.707|0.314|<0.05
91535270|NCT01078246|182948704|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.65||||0.015|TWO_SIDED|95.0|1.102|2.47|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.470|1.102|0.015
91535271|NCT01078246|182948704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.622||||0.018|TWO_SIDED|95.0|1.085|2.425|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.425|1.085|0.018
91535272|NCT01078246|182948705|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.75||||0.423|TWO_SIDED|95.0|0.37|1.517|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.517|0.370|0.423
91535273|NCT01078246|182948705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.208||||0.631|TWO_SIDED|95.0|0.559|2.612|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.612|0.559|0.631
91535274|NCT01078246|182948705|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.845||||0.592|TWO_SIDED|95.0|0.458|1.561|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.561|0.458|0.592
91758571|NCT02524158|183410411|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.340
91758572|NCT02524158|183410412|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
91758573|NCT02524158|183410413|SUPERIORITY|||||||0.005||||||The a priori specified threshold is p \< 0.05|Mixed Models Analysis|||||||0.005
91758574|NCT02524158|183410414|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
91535275|NCT01078246|182948705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.022||||0.943|TWO_SIDED|95.0|0.565|1.85|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.850|0.565|0.943
91535276|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.708||||0.109|TWO_SIDED|95.0|0.464|1.08|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.080|0.464|0.109
91535277|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.356|TWO_SIDED|95.0|0.486|1.296|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.296|0.486|0.356
91535278|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.556||||0.039|TWO_SIDED|95.0|1.022|2.37|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.370|1.022|0.039
91535279|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.033|TWO_SIDED|95.0|1.036|2.361|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.361|1.036|0.033
91535280|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.125|TWO_SIDED|95.0|0.861|3.437|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen.||||3.437|0.861|0.125
91535281|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.056||||0.881|TWO_SIDED|95.0|0.517|2.155|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen.||||2.155|0.517|0.881
91535282|NCT01078246|182948706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.077||||0.107|TWO_SIDED|95.0|0.854|5.05|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen.||||5.05|0.854|0.107
91535283|NCT00235495|182948707|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.1||The generalized linear model with log link function is tested at the one-sided alpha level of 0.025.|Regression, Logistic|Adjustment is made for baseline NIHSS and Thrombolysis stratum.|Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.|Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).||1.10|0.84|
91535284|NCT00235495|182948708|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.8|1.09|||Regression, Logistic|||||1.09|0.80|
91535285|NCT00235495|182948709|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.66|1.49|||Regression, Logistic|||||1.49|0.66|
91535286|NCT00235495|182948710|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||||TWO_SIDED|99.0|0.71|1.1|||Regression, Logistic|||||1.10|0.71|
91535287|NCT00235495|182948711|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03|||||TWO_SIDED|99.0|0.82|1.28|||Regression, Logistic|||||1.28|0.82|
91535288|NCT00235495|182948712|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.85|1.13|||Regression, Logistic|||||1.13|0.85|
91758575|NCT02524158|183410415|SUPERIORITY|||||||0.044||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.044
91535289|NCT00235495|182948713|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98|||||TWO_SIDED|99.0|0.87|1.11|||Regression, Logistic|||||1.11|0.87|
91535290|NCT00235495|182948714|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95|||||TWO_SIDED|99.0|0.83|1.1|||Regression, Logistic|||||1.10|0.83|
91535291|NCT00235495|182948715|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.84|1.17|||Regression, Logistic|||||1.17|0.84|
91535292|NCT00235495|182948716|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.84|1.02|||Regression, Logistic|||||1.02|0.84|
91535293|NCT00235495|182948717|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|73098.0||||0.913||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.913
91535294|NCT00235495|182948718|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|44853.5||||0.923||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.923
91535295|NCT00235495|182948719|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.79|1.76|||Regression, Logistic|||||1.76|0.79|
91535296|NCT00235495|182948720|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.47|2.15|||Regression, Logistic|||||2.15|0.47|
91535297|NCT00235495|182948721|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.39|3.41|||Regression, Logistic|||||3.41|0.39|
91535298|NCT00235495|182948722|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.69|||||TWO_SIDED|95.0|0.98|2.94|||Regression, Logistic|||||2.94|0.98|
91535299|NCT00235495|182948723|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|10.8|||||TWO_SIDED|95.0|4.37|26.72|||Regression, Logistic|||||26.72|4.37|
91535300|NCT00235495|182948724|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.58|||||TWO_SIDED|95.0|1.09|6.12|||Regression, Logistic|||||6.12|1.09|
91535301|NCT00235495|182948725|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.42|||||TWO_SIDED|95.0|1.02|5.78|||Regression, Logistic|||||5.78|1.02|
91535302|NCT00235495|182948726|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.68|2.01|||Regression, Logistic|||||2.01|0.68|
91535303|NCT00235495|182948727|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.61|||Regression, Logistic|||||1.61|0.68|
91535304|NCT00235495|182948728|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.63|||Regression, Logistic|||||1.63|0.74|
91535305|NCT01639443|182948729|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of percentage of clinic capacity filled. We are powered to detect a 0.5 Standard Deviation (SD) difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||<0.0001
91758576|NCT02524158|183410416|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
91758577|NCT02524158|183410417|SUPERIORITY|||||||0.01||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.010
91758578|NCT02524158|183410418|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
91758579|NCT02524158|183410419|SUPERIORITY||||||<|0.1|||||||Mixed Models Analysis|||||||<0.10
91535306|NCT01639443|182948730|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||We calculated this measure on the patient level. Our null hypothesis is that the lag time between scheduling and appointment, measured in days, will not differ between groups. We are powered to detect a 0.3 SD difference in lag time (Type I error rate = 5%; Power = 84%), accounting for the large sampling ratio (approximately 14:1).||||0.29
91535307|NCT01639443|182948731|SUPERIORITY_OR_OTHER|||||||0.49||||||We would have only expected 2 patients to be bumped in the Experimental Group, and observed 0.|Fisher Exact|||We did not explicitly power this study to detect differences in the number of service bumps, but we can compare them using Fisher's Exact Test||||0.49
91535308|NCT01639443|182948732|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||We calculated this measure on the patient level, but were hampered by a large sampling ratio (more than 50:1). Our null hypothesis is that the number of polyps detected will not differ between groups. We are powered to detect a 0.25 SD difference in polyp count per patient (Type I error rate = 5%; Power = 80%).||||0.05
91535309|NCT01639443|182948733|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of length of workday. We are powered to detect approximately 0.5 SD difference in workday length in hours (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.024
91535310|NCT01639443|182948734|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of cost per day. We are powered to detect a 0.5 SD difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.11
91535311|NCT02806895|182948739|SUPERIORITY|||||||0.0062|||||||ANOVA|||||||0.0062
91535312|NCT02806895|182948740|SUPERIORITY|||||||0.0432|||||||ANOVA|||||||0.0432
91535313|NCT02806895|182948741|SUPERIORITY|||||||0.0414|||||||McNemar|||||||0.0414
91535314|NCT02806895|182948742|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
91535315|NCT02806895|182948743|SUPERIORITY|||||||0.1435|||||||McNemar|||||||0.1435
91535316|NCT02806895|182948744|SUPERIORITY|||||||0.1796|||||||McNemar|||||||0.1796
91535317|NCT02806895|182948745|SUPERIORITY|||||||0.1094|||||||McNemar|||||||0.1094
91535318|NCT02806895|182948746|SUPERIORITY|||||||0.4531|||||||McNemar|||||||0.4531
91535319|NCT02806895|182948747|SUPERIORITY|||||||0.3593|||||||McNemar|||||||0.3593
91535320|NCT02806895|182948748|SUPERIORITY|||||||0.6072|||||||McNemar|||||||0.6072
91535321|NCT02806895|182948749|SUPERIORITY|||||||0.7905|||||||McNemar|||||||0.7905
91535322|NCT02806895|182948750|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91535323|NCT02806895|182948751|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91535324|NCT02806895|182948752|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
91535325|NCT02806895|182948753|SUPERIORITY|||||||0.4116|||||||ANOVA|||||||0.4116
91535326|NCT02806895|182948754|SUPERIORITY|||||||0.1991|||||||ANOVA|||||||0.1991
91535327|NCT02806895|182948755|SUPERIORITY|||||||0.0806|||||||ANOVA|||||||0.0806
91535328|NCT02806895|182948756|SUPERIORITY|||||||0.9391|||||||ANOVA|||||||0.9391
91535329|NCT02806895|182948757|SUPERIORITY|||||||0.2116|||||||ANOVA|||||||0.2116
91535330|NCT02806895|182948758|SUPERIORITY|||||||0.1604|||||||ANOVA|||||||0.1604
91535331|NCT02806895|182948759|SUPERIORITY|||||||0.2144|||||||ANOVA|||||||0.2144
91535332|NCT02806895|182948760|SUPERIORITY|||||||0.0387|||||||ANOVA|||||||0.0387
91535333|NCT02806895|182948761|SUPERIORITY|||||||0.3426|||||||ANOVA|||||||0.3426
91535334|NCT02806895|182948762|SUPERIORITY|||||||0.1531|||||||ANOVA|||||||0.1531
91535335|NCT02806895|182948763|SUPERIORITY|||||||0.5603|||||||ANOVA|||||||0.5603
91535336|NCT02806895|182948764|SUPERIORITY|||||||0.4851|||||||ANOVA|||||||0.4851
91535337|NCT02806895|182948765|SUPERIORITY|||||||0.0241|||||||ANOVA|||||||0.0241
91535338|NCT00601965|182948781|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log rank test = 32.67, df = 3||||||<.001
91535339|NCT00601965|182948782|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Beta = -0.48, 95% CI = -0.84 to -0.11||||||0.01
91535340|NCT02387749|182948797|SUPERIORITY|||||||0.005|||||||Chi-squared, Corrected|||||||0.005
91535341|NCT00813488|182948888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|0.06|0.2|||Mixed effects ANOVA crossover model|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.20|0.06|0.0004
91535342|NCT00813488|182948889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2242|TWO_SIDED|95.0|-0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.05|-0.01|0.2242
91535343|NCT00813488|182948890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.0106|TWO_SIDED|95.0|0.01|0.11||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.11|0.01|0.0106
91758580|NCT02524158|183410420|SUPERIORITY|||||||0.202|||||||ANCOVA|||||||0.202
91758581|NCT02524158|183410421|SUPERIORITY|||||||0.369|||||||ANCOVA|||||||0.369
91758582|NCT02524158|183410422|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
91758583|NCT02524158|183410423|SUPERIORITY|||||||0.067|||||||ANCOVA|||||||0.067
91758584|NCT02524158|183410425|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
91758585|NCT02524158|183410426|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
91758586|NCT02524158|183410427|SUPERIORITY|||||||0.036||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.036
91758587|NCT02524158|183410428|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
91758588|NCT01835158|183410429|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.012|TWO_SIDED|95.0|0.46|0.95|||Log Rank|||||.95|.46|0.012
91758589|NCT01835158|183410430|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.26||||||||1.26|0.50|
91758590|NCT00596830|183410432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.179||||0.064|TWO_SIDED|95.0|0.99|1.404||The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.|Log Rank|||||1.404|0.990|0.064
91758591|NCT00596830|183410433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.27|TWO_SIDED|95.0|0.925|1.315||2-sided p-value is from the unstratified log-rank test|Log Rank||HR was based on the Cox proportional hazards model|||1.315|0.925|0.270
91758592|NCT00596830|183410434|SUPERIORITY_OR_OTHER||Risk difference|-1.472||||0.685|TWO_SIDED|95.0|-8.6|5.6|||Chi-squared||Risk difference confidence interval was calculated based on a normal distribution.|||5.6|-8.6|0.685
91758593|NCT00939562|183410450|SUPERIORITY_OR_OTHER||Ratio|102.95||||||90.0|94.74|111.86|||||The adjusted mean differences and 90% confidence intervals (CIs) were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||111.86|94.74|
91758594|NCT00939562|183410451|SUPERIORITY_OR_OTHER||Ratio|104.67||||||90.0|98.95|110.73|||||The adjusted mean differences and 90% CIs were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||110.73|98.95|
91758595|NCT00098306|183410507|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|STANDARD_ERROR_OF_MEAN|0.1571|||TWO_SIDED|97.5|-1.141|-0.435||||||The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.435|-1.141|
91758596|NCT00098306|183410507|SUPERIORITY_OR_OTHER||LS mean difference|-0.922|STANDARD_ERROR_OF_MEAN|0.1568|||TWO_SIDED|97.5|-1.275|-0.57||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.570|-1.275|
91758597|NCT00098306|183410508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.78|4.67|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||4.67|1.78|<0.0001
91758598|NCT00098306|183410508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.26|5.95|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.95|2.26|<0.0001
91758599|NCT00098306|183410508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.96|||<|0.0001|TWO_SIDED|95.0|2.36|6.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.64|2.36|<0.0001
91758600|NCT00098306|183410508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.11|||<|0.0001|TWO_SIDED|95.0|3.04|8.59|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.59|3.04|<0.0001
91535344|NCT00813488|182948891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.21|0.4||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.40|.21|<0.0001
91535345|NCT00813488|182948892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|0.18|0.37||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.37|0.18|<0.0001
91535346|NCT00813488|182948893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|0.08|0.27||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.27|0.08|0.0002
91535347|NCT00813488|182948900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.5|||ANOVA|||||0.50|0.25|<0.0001
91535348|NCT00813488|182948901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.0001|TWO_SIDED|95.0|0.55|1.1|||ANOVA|||||1.10|.55|<0.0001
91535349|NCT00813488|182948902|SUPERIORITY_OR_OTHER|||||||0.5575|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.5575
91535350|NCT00813488|182948903|SUPERIORITY_OR_OTHER|||||||0.0981|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0981
91535351|NCT00813488|182948904|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0443
91535352|NCT00813488|182948905|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
91535353|NCT00813488|182948906|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
91535354|NCT00813488|182948907|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0018
91535355|NCT00813488|182948908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|0.58|0.9||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.90|0.58|<0.0001
91535356|NCT00813488|182948910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1464||||0.7012|TWO_SIDED|95.0|0.6|2.3|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.3|0.6|0.7012
91535357|NCT00813488|182948911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0704||||0.6545|TWO_SIDED|95.0|0.8|1.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.8|0.6545
91535358|NCT00813488|182948912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2544||||0.0407|TWO_SIDED|95.0|1.0|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.0|0.0407
91535359|NCT00813488|182948913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5745||||0.0007|TWO_SIDED|95.0|1.2|2.0|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.2|0.0007
91758601|NCT00098306|183410509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.63|4.13|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.13|1.63|<0.0001
91758602|NCT00098306|183410509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.79|4.54|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.54|1.79|<0.0001
91512998|NCT00116805|182897654|SUPERIORITY_OR_OTHER||Difference in proportions|4.3|STANDARD_ERROR_OF_MEAN|3.0||0.148|TWO_SIDED|95.0|-1.5|10.2||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg seroconversion.||10.2|-1.5|0.148
91512999|NCT00116805|182897655|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.9||0.757|TWO_SIDED|95.0|-4.8|6.5||P-value above for HBsAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||6.5|-4.8|0.757
91513000|NCT00116805|182897655|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.6||0.733|TWO_SIDED|95.0|-4.2|5.9||P-value above corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to seroconversion to anti-HBs.||5.9|-4.2|0.733
91513001|NCT01159938|182897667|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.617|TWO_SIDED|95.0|-0.78|1.3||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.30|-0.78|0.617
91513002|NCT01159938|182897667|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.732|TWO_SIDED|95.0|-1.23|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.23|0.732
91513003|NCT01159938|182897667|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.715|TWO_SIDED|95.0|-1.2|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.20|0.715
91513004|NCT01159938|182897667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.177|TWO_SIDED|95.0|-0.85|0.16||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.16|-0.85|0.177
91513005|NCT01159938|182897667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.579|TWO_SIDED|95.0|-0.94|0.53||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.53|-0.94|0.579
91513006|NCT01159938|182897667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.167|TWO_SIDED|95.0|-1.19|0.21||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.21|-1.19|0.167
91513007|NCT01159938|182897668|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.676|TWO_SIDED|95.0|-1.1|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.10|0.676
91513008|NCT01159938|182897668|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.957|TWO_SIDED|95.0|-1.27|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-1.27|0.957
91513009|NCT01159938|182897668|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.513|TWO_SIDED|95.0|-1.68|0.85||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.85|-1.68|0.513
91513010|NCT01159938|182897668|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.623|TWO_SIDED|95.0|-0.47|0.28||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.28|-0.47|0.623
91513011|NCT01159938|182897668|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.916|TWO_SIDED|95.0|-0.51|0.57||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.57|-0.51|0.916
91513012|NCT01159938|182897668|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.413|TWO_SIDED|95.0|-0.73|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.73|0.413
91513013|NCT01159938|182897669|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.724|TWO_SIDED|95.0|-0.94|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-0.94|0.724
91513014|NCT01159938|182897669|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.479|TWO_SIDED|95.0|-1.05|2.2||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||2.20|-1.05|0.479
91535360|NCT00813488|182948914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5828||||0.0372|TWO_SIDED|95.0|1.0|2.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.4|1.0|0.0372
91513015|NCT01159938|182897669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18||||0.825|TWO_SIDED|95.0|-1.76|1.41||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||1.41|-1.76|0.825
91513016|NCT01159938|182897669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.378|TWO_SIDED|95.0|-0.65|0.25||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.25|-0.65|0.378
91513017|NCT01159938|182897669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.553|TWO_SIDED|95.0|-0.84|0.46||The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.46|-0.84|0.553
91535361|NCT00813488|182948915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3722||||0.3099|TWO_SIDED|95.0|0.7|2.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.5|0.7|0.3099
91535362|NCT00813488|182948916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8434||||0.5777|TWO_SIDED|95.0|0.5|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.5|.5|0.5777
91535363|NCT00813488|182948917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.9567|TWO_SIDED|95.0|0.6|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.6|0.9567
91535364|NCT00813488|182948918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1366||||0.4253|TWO_SIDED|95.0|0.8|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.8|0.4253
91535365|NCT00813488|182948919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4269||||0.0038|TWO_SIDED|95.0|1.1|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.1|0.0038
91535366|NCT00813488|182948920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5118||||0.0012||95.0|1.2|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.2|0.0012
91535367|NCT00813488|182948921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5826||||0.0074|TWO_SIDED|95.0|1.1|2.2|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.2|1.1|0.0074
91535368|NCT00813488|182948922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.059||||0.8444|TWO_SIDED|95.0|0.6|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.6|0.8444
91535369|NCT00813488|182948923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6033|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
91535370|NCT00813488|182948924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3334|||<|0.0001|TWO_SIDED|95.0|1.2|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.5|1.2|<0.0001
91535371|NCT01779375|182948934|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
91535372|NCT01779375|182948935|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for presentation.||||>0.05
91535373|NCT01779375|182948937|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for display.||||>0.05
91535374|NCT00836810|182948942|SUPERIORITY||||||<|0.001||||||A priory test for statistical significance was P\<0.05|t-test, 2 sided|||||||<0.001
91535375|NCT00836810|182948942|SUPERIORITY||||||<|0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.001
91535376|NCT00836810|182948942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||||||A priori statistical significance set as P\<0.05|t-test, 2 sided|||||||<0.01
91535377|NCT00836810|182948943|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|A priori statistical significance set at P\<0.05||||||<0.001
91535378|NCT00836810|182948943|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
91535379|NCT00836810|182948943|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
91535380|NCT00836810|182948944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.023
91535381|NCT00836810|182948944|SUPERIORITY|||||||0.0906||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.0906
91535382|NCT00836810|182948944|SUPERIORITY|||||||0.044||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.044
91535383|NCT00836810|182948945|SUPERIORITY|||||||0.007||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.007
91535384|NCT00836810|182948945|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
91535385|NCT00836810|182948945|SUPERIORITY|||||||0.57||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.57
91535386|NCT00836810|182948946|SUPERIORITY|||||||0.022||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.022
91535387|NCT00836810|182948946|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
91535388|NCT00836810|182948946|SUPERIORITY|||||||0.51||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.51
91535389|NCT00836810|182948947|SUPERIORITY|||||||0.003||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.003
91535390|NCT00836810|182948947|SUPERIORITY|||||||0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.001
91535391|NCT00836810|182948947|SUPERIORITY|||||||0.88||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.88
91513018|NCT01159938|182897669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.512|TWO_SIDED|95.0|-0.83|0.42||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.42|-0.83|0.512
91513019|NCT01159938|182897670|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.466|TWO_SIDED|95.0|-1.09|0.51||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.51|-1.09|0.466
91513020|NCT01159938|182897670|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.449|TWO_SIDED|95.0|-1.6|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.60|0.449
91513021|NCT01159938|182897670|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.792|TWO_SIDED|95.0|-1.25|0.96||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.96|-1.25|0.792
91513022|NCT01159938|182897670|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16||||0.493|TWO_SIDED|95.0|-0.63|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.63|0.493
91513023|NCT01159938|182897670|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.091|TWO_SIDED|95.0|-1.25|0.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.10|-1.25|0.091
91513024|NCT01159938|182897670|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.425|TWO_SIDED|95.0|-0.39|0.9||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.90|-0.39|0.425
91513025|NCT01159938|182897671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.275|TWO_SIDED|95.0|-1.36|0.4||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.40|-1.36|0.275
91513026|NCT01159938|182897671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.784||95.0|-1.44|1.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.10|-1.44|0.784
91513027|NCT01159938|182897671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79||||0.197|TWO_SIDED|95.0|-2.01|0.43||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.43|-2.01|0.197
91513028|NCT01159938|182897671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.122|TWO_SIDED|95.0|-0.9|0.11||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.11|-0.90|0.122
91513029|NCT01159938|182897671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-1.16|0.246
91513030|NCT01159938|182897671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.298|TWO_SIDED|95.0|-1.06|0.33||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.33|-1.06|0.298
91758603|NCT00098306|183410509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001|TWO_SIDED|95.0|1.83|4.67|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.67|1.83|<0.0001
91513031|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.49||||0.024|TWO_SIDED|95.0|-6.5|-0.48||P-value is for the Least Square (LS) mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.||||-0.48|-6.50|0.024
91513032|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.859|TWO_SIDED|95.0|-2.59|3.09||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||3.09|-2.59|0.859
91758604|NCT00098306|183410509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.08|5.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.32|2.08|<0.0001
91758605|NCT00098306|183410510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.92|4.88|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.88|1.92|<0.0001
91758606|NCT00098306|183410510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.22|5.68|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.68|2.22|<0.0001
91535392|NCT05460663|182948981|EQUIVALENCE|Paired Wilcoxon signed ranks tests were used to compare changes at 12-week, 18-week, or 24-week follow-ups from the baseline scores for all measurements in each training modality separately and combined. Comparisons were made with participants who had data at both baseline and the follow-up. Difference-in-difference comparison of changes between two training modalities at each follow-up from the baseline were made to assess differences between CBT and in-person training.||||||0.083||||||The reported P-value is for differences between groups at 24-weeks post-intervention.The Benjamini \& Hochberg adjustment was applied to control for the false-discovery rate among all pairwise pre-post comparisons.|Wilcoxon (Mann-Whitney)|||||||.083
91535393|NCT03068468|182949016|SUPERIORITY||Difference|-0.2||||0.8483|TWO_SIDED|95.0|-2.0|1.6|||Mixed model for repeated measures (MMRM)|||28-item:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on a mixed model for repeated measures model (MMRM), with change from baseline in 28-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment group-by-time interaction, baseline 28-item PSPRS, baseline 28-item PSPRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.6|-2.0|0.8483
91535394|NCT03068468|182949016|SUPERIORITY||Difference|-0.28||||0.6503|TWO_SIDED|95.0|-1.5|0.94|||MMRM|||15-items:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in 15-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment groupby-time interaction, baseline 15-item PSPRS, baseline 15-item PSPRS by time interaction, baseline Color Trails 2 test(\<=170 or \>170 seconds) and region.||0.94|-1.50|0.6503
91535395|NCT03068468|182949018|SUPERIORITY||Difference|0.4||||0.6031|TWO_SIDED|95.0|-1.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MDS-UPDRS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline MDS-UPDRS, baseline MDS-UPDRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|-1.0|0.6031
91535396|NCT03068468|182949019|SUPERIORITY||Difference|0.0||||0.7743|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with CGI-C as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.7743
91535397|NCT03068468|182949020|SUPERIORITY||Difference|0.038||||0.318|TWO_SIDED|95.0|-0.036|0.112|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-cognitive composite battery as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline PSP-cognitive composite battery, baseline PSP-cognitive composite battery by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.112|-0.036|0.3180
91535398|NCT03068468|182949021|SUPERIORITY||Difference|-0.2||||0.827|TWO_SIDED|95.0|-1.8|1.4|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in RBANS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline RBANS , baseline RBANS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds and region.||1.4|-1.8|0.8270
91535399|NCT03068468|182949022|SUPERIORITY||Difference|-0.2||||0.9304|TWO_SIDED|95.0|-3.6|3.3|||MMRM|||Physical scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-QoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.3|-3.6|0.9304
91535400|NCT03068468|182949022|SUPERIORITY||Difference|0.5||||0.7859|TWO_SIDED|95.0|-2.8|3.7|||MMRM|||Mental scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.7|-2.8|0.7859
91535401|NCT03068468|182949022|SUPERIORITY||Difference|-1.7||||0.4297|TWO_SIDED|95.0|-5.8|2.5|||MMRM|||Satisfaction With Your Life Today: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.5|-5.8|0.4297
91758607|NCT00098306|183410510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.05|5.31|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.31|2.05|<0.0001
91758608|NCT00098306|183410510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.5|6.51|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.51|2.50|<0.0001
91758609|NCT00098306|183410511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.0006|TWO_SIDED|95.0|1.46|4.04|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.04|1.46|0.0006
91513033|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19||||0.155|TWO_SIDED|95.0|-5.25|0.87||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.87|-5.25|0.155
91513034|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.685|TWO_SIDED|95.0|-3.46|2.3||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.30|-3.46|0.685
91513035|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.84||||0.292|TWO_SIDED|95.0|-5.33|1.64||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||1.64|-5.33|0.292
91513036|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04||||0.216|TWO_SIDED|95.0|-1.25|5.33||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||5.33|-1.25|0.216
91513037|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.87||||0.065|TWO_SIDED|95.0|-5.92|0.18||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.18|-5.92|0.065
91513038|NCT01159938|182897672|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.954|TWO_SIDED|95.0|-2.96|2.8||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.80|-2.96|0.954
91513039|NCT01159938|182897673|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.905|TWO_SIDED|95.0|-0.31|0.27||P-value is for Least Square (LS) mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.27|-0.31|0.905
91513040|NCT01159938|182897673|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.004|TWO_SIDED|95.0|0.14|0.69||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.69|0.14|0.004
91535402|NCT03068468|182949023|SUPERIORITY||Difference|2.0||||0.2084|TWO_SIDED|95.0|-1.1|5.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in SEADL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for SEADL , baseline SEADL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||5.2|-1.1|0.2084
91758610|NCT00098306|183410511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|1.9|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.23|1.90|<0.0001
91513041|NCT01159938|182897673|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.584|TWO_SIDED|95.0|-0.41|0.23||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.23|-0.41|0.584
91513042|NCT01159938|182897673|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.436|TWO_SIDED|95.0|-0.19|0.44||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.44|-0.19|0.436
91513043|NCT04837482|182897690|NON_INFERIORITY|Noninferiority of AGN-190584 was concluded if the lower bound of the 95% CI of the least-square mean difference between AGN-190584 and vehicle was greater than the pre-specified margin of -0.25.|Least-Square (LS) Mean|-0.224|STANDARD_ERROR_OF_MEAN|0.0602||0.0006|TWO_SIDED|95.0|-0.346|-0.103|||Mixed Models Analysis|Linear mixed-effects model with repeated measures||||-0.103|-0.346|0.0006
91513044|NCT02979535|182897698|OTHER||GMT ratio|0.947|||||TWO_SIDED|95.0|0.773|1.16||||||Antigen HPV-16||1.16|0.773|
91513045|NCT02979535|182897698|OTHER||GMT ratio|0.986|||||TWO_SIDED|95.0|0.803|1.21||||||Antigen HPV-18||1.21|0.803|
91513046|NCT02979535|182897699|OTHER||GMT ratio|0.977|||||TWO_SIDED|95.0|0.653|1.46||||||Dengue Virus Serotype 1||1.46|0.653|
91513047|NCT02979535|182897699|OTHER||GMT ratio|0.911|||||TWO_SIDED|95.0|0.654|1.27||||||Dengue Virus Serotype 2||1.27|0.654|
91513048|NCT02979535|182897699|OTHER||GMT ratio|0.921|||||TWO_SIDED|95.0|0.727|1.17||||||Dengue Virus Serotype 3||1.17|0.727|
91513049|NCT02979535|182897699|OTHER||GMT ratio|0.931|||||TWO_SIDED|95.0|0.733|1.18||||||Dengue Virus Serotype 4||1.18|0.733|
91513050|NCT04820673|182897713|OTHER||||||<|0.0001||||||P\<0.0001, calculated by t-test, corresponds to baseline response group domain scores in comparison to week-12 domain scores (CFB). CFB is calculated using available matching data for each domain. Higher domain scores indicate higher disease burden.|t-test, 2 sided|||Week 12 vs Baseline||||<.0001
91758611|NCT00098306|183410511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.32|7.25|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.25|2.32|<0.0001
91758612|NCT00098306|183410511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.0001|TWO_SIDED|95.0|2.82|8.77|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.77|2.82|<0.0001
91758613|NCT00098306|183410513|SUPERIORITY_OR_OTHER||LS mean difference|54.49|STANDARD_ERROR_OF_MEAN|12.435|||TWO_SIDED|95.0|30.07|78.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||78.92|30.07|
91758614|NCT00098306|183410513|SUPERIORITY_OR_OTHER||LS mean difference|58.94|STANDARD_ERROR_OF_MEAN|12.378|||TWO_SIDED|95.0|34.63|83.26||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.26|34.63|
91758615|NCT00098306|183410513|SUPERIORITY_OR_OTHER||LS mean difference|58.56|STANDARD_ERROR_OF_MEAN|12.677|||TWO_SIDED|95.0|33.66|83.46||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.46|33.66|
91513051|NCT00587587|182897719|SUPERIORITY_OR_OTHER|||||||1||||||"P-value compares overall incidence of AEs between groups, ie Apligraf 12/17 and Control 10/13.~UADE is defined in 21CFR812.3(s)"|Fisher Exact|||Fisher's exact test used to evaluate treatment differences between Apligraf subjects and Control subjects experiencing any AEs.||||1.0000
91513052|NCT00587587|182897720|SUPERIORITY_OR_OTHER|||||||0.5863||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5863
91513053|NCT00587587|182897721|SUPERIORITY_OR_OTHER|||||||0.3783||95.0|||||Fisher Exact|||||||0.3783
91513054|NCT00587587|182897722|SUPERIORITY_OR_OTHER|||||||0.7149|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar firmness evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7149
91513055|NCT00587587|182897723|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar thickness evaluated using a 2-tailed Wilcoxon rank sum test||||0.1670
91513056|NCT00587587|182897724|SUPERIORITY_OR_OTHER|||||||0.7221|TWO_SIDED|0.0|||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7221
91513057|NCT00587587|182897725|SUPERIORITY_OR_OTHER|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.4080
91513058|NCT00587587|182897726|SUPERIORITY_OR_OTHER|||||||0.9556||0.0|||||Wilcoxon (Mann-Whitney)|||Differences evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.9556
91513059|NCT01162005|182897727|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
91513060|NCT00466193|182897743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for treatment|ANCOVA|||||||<0.001
91513061|NCT00466193|182897745|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for treatment|ANCOVA|||||||0.006
91513062|NCT00466193|182897748|SUPERIORITY_OR_OTHER|||||||0.0041||95.0||||P-value is for treatment|ANCOVA|||||||0.0041
91513063|NCT00086346|182897754|SUPERIORITY_OR_OTHER|||||||0.342|||||||Rank ANCOVA|||||||0.342
91513064|NCT00086346|182897755|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|||Comparison between treatment groups of percentages of patients with biopsy-confirmed acute rejection.||||0.017
91513065|NCT00086346|182897756|SUPERIORITY_OR_OTHER||||||>|0.05|||||||1 way ANOVA, two sided|||||||>0.05
91513066|NCT00086346|182897757|NON_INFERIORITY_OR_EQUIVALENCE|The a priori criterion for declaring non-inferiority was a lower bound of the 95% confidence interval (CI) having a ≥ 5% difference in graft loss. -5.2 is \< 5 % difference.|Mean Difference (Net)|-1.2||||||95.0|-5.2|2.8|||||Weighted difference in percentage of graft loss: (CNI% minus SRL%); negative values are favorable to CNI group|||2.8|-5.2|
91513067|NCT01075074|182897773|SUPERIORITY_OR_OTHER|||||||0.006||||||Corrected for 6 comparisons.|Kruskal-Wallis|||A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.||||0.006
91513068|NCT01075074|182897773|SUPERIORITY_OR_OTHER||Median Difference (Net)|16.0||||0.03|TWO_SIDED|95.0|1.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|1|0.03
91513069|NCT01075074|182897773|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0||||0.01|TWO_SIDED|95.0|2.0|31.0|||Wilcoxon (Mann-Whitney)|||||31|2|0.01
91513070|NCT01075074|182897773|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-16.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-16|1.0
91513071|NCT01075074|182897774|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||P values is corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
91513072|NCT01075074|182897774|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
91513073|NCT01075074|182897774|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0004|TWO_SIDED|95.0|98.0|300.0|||Wilcoxon (Mann-Whitney)|||||300|98|0.0004
91513074|NCT01075074|182897774|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0003|TWO_SIDED|95.0|98.0|278.0|||Wilcoxon (Mann-Whitney)|||||278|98|0.0003
91513075|NCT01075074|182897774|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-105.0|83.0|||Wilcoxon (Mann-Whitney)|||||83|-105|0.86
91513076|NCT01075074|182897775|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.0005
91513077|NCT01075074|182897775|SUPERIORITY_OR_OTHER||Median Difference (Net)|38.0||||0.01|TWO_SIDED|95.0|8.0|50.0|||Wilcoxon (Mann-Whitney)|||||50|8|0.01
91513078|NCT01075074|182897775|SUPERIORITY_OR_OTHER||Median Difference (Net)|40.0||||0.003|TWO_SIDED|95.0|12.0|47.0|||Wilcoxon (Mann-Whitney)|||||47|12|0.003
91513079|NCT01075074|182897775|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.95|TWO_SIDED|95.0|-18.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-18|0.95
91513080|NCT01075074|182897776|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.03
91758616|NCT00098306|183410513|SUPERIORITY_OR_OTHER||LS mean difference|68.47|STANDARD_ERROR_OF_MEAN|12.617|||TWO_SIDED|95.0|43.69|93.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||93.25|43.69|
91758617|NCT00098306|183410514|SUPERIORITY_OR_OTHER||LS mean difference|284.21|STANDARD_ERROR_OF_MEAN|51.779|||TWO_SIDED|95.0|182.51|385.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||385.92|182.51|
91758618|NCT00098306|183410514|SUPERIORITY_OR_OTHER||LS mean difference|303.07|STANDARD_ERROR_OF_MEAN|51.507|||TWO_SIDED|95.0|201.9|404.23||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||404.23|201.90|
91513081|NCT01075074|182897776|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.01
91513082|NCT01075074|182897776|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.04|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.04
91513083|NCT01075074|182897776|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.92|TWO_SIDED|95.0|-30.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|-30|0.92
91513084|NCT05209191|182897789|SUPERIORITY||Mean Difference (Net)|7.28|STANDARD_DEVIATION|0.65||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
91513085|NCT05209191|182897791|SUPERIORITY||Mean Difference (Net)|0.08||||0.38|TWO_SIDED||||||t-test, 2 sided|||Paired t-test.||||.38
91513086|NCT05209191|182897792|SUPERIORITY||Chi square|52.07||||0.001|TWO_SIDED||||||Chi-squared|||||||.001
91513087|NCT01172938|182897793|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.0||||0.0001|TWO_SIDED|95.0|9.7|28.3|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.3|9.7|0.0001
91513088|NCT01172938|182897793|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3||||0.0166|TWO_SIDED|95.0|2.2|20.4|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.4|2.2|0.0166
91513089|NCT01172938|182897794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.159||||0.0017|TWO_SIDED|95.0|-0.258|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.060|-0.258|0.0017
91513090|NCT01172938|182897794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.113||||0.0252|TWO_SIDED|95.0|-0.211|-0.014|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.014|-0.211|0.0252
91513091|NCT01172938|182897795|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.2|||<|0.0001|TWO_SIDED|95.0|13.4|30.9||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.9|13.4|<0.0001
91513092|NCT01172938|182897795|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4||||0.0038|TWO_SIDED|95.0|4.2|20.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.7|4.2|0.0038
91758619|NCT00098306|183410514|SUPERIORITY_OR_OTHER||LS mean difference|213.34|STANDARD_ERROR_OF_MEAN|49.679|||TWO_SIDED|95.0|115.77|310.92||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||310.92|115.77|
91758620|NCT00098306|183410514|SUPERIORITY_OR_OTHER||LS mean difference|235.74|STANDARD_ERROR_OF_MEAN|49.416|||TWO_SIDED|95.0|138.68|332.8||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||332.80|138.68|
91513093|NCT01172938|182897796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.182||||0.0005|TWO_SIDED|95.0|-0.283|-0.08||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.080|-0.283|0.0005
91513094|NCT01172938|182897796|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.135||||0.0091|TWO_SIDED|95.0|-0.236|-0.034||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.034|-0.236|0.0091
91513095|NCT01172938|182897797|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.42||||0.0056|TWO_SIDED|95.0|0.71|4.13||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.13|0.71|0.0056
91758621|NCT00098306|183410515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.34|0.6|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.60|0.34|<0.0001
91758622|NCT00098306|183410515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.28|0.5|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.50|0.28|<0.0001
91758623|NCT00098306|183410516|SUPERIORITY_OR_OTHER||LS mean difference|-0.697|STANDARD_ERROR_OF_MEAN|0.1347|||TWO_SIDED|95.0|-0.961|-0.432||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.432|-0.961|
91758624|NCT00098306|183410516|SUPERIORITY_OR_OTHER||LS mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|95.0|-1.065|-0.538||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.538|-1.065|
91758625|NCT00098306|183410516|SUPERIORITY_OR_OTHER||LS mean difference|-0.767|STANDARD_ERROR_OF_MEAN|0.1497|||TWO_SIDED|95.0|-1.061|-0.474||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.474|-1.061|
91758626|NCT00098306|183410516|SUPERIORITY_OR_OTHER||LS mean difference|-0.931|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-1.225|-0.638||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.638|-1.225|
91758627|NCT00098306|183410517|SUPERIORITY_OR_OTHER||LS mean difference|-0.853|STANDARD_ERROR_OF_MEAN|0.1621|||TWO_SIDED|97.5|-1.217|-0.489||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.489|-1.217|
91758628|NCT00098306|183410517|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|97.5|-1.385|-0.658||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.658|-1.385|
91758629|NCT00820222|183410555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.36|TWO_SIDED|95.0|0.26|1.63|||Odds Ratio||The Odds Ratio is based on a logistic regression model. The P-value for the test of Odds Ratio is 1.|||1.63|0.26|0.360
91758630|NCT00820222|183410556|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.64|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.64|1.04|0.021
91758631|NCT00820222|183410558|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.095|TWO_SIDED|95.0|0.95|1.9|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.90|0.95|0.095
91758632|NCT00820222|183410559|SUPERIORITY||Odds Ratio (OR)|0.7984||||0.2731|TWO_SIDED|95.0|0.5407|1.1771|||Fisher Exact|||Comparison for Overall Response (CR+PR)||1.1771|0.5407|0.2731
91758633|NCT00820222|183410560|SUPERIORITY||Odds Ratio (OR)|0.9016||||0.6106|TWO_SIDED|95.0|0.6315|1.2866|||Fisher Exact|||Comparison for Clinical Benefit||1.2866|0.6315|0.6106
91758634|NCT01336023|183410583|NON_INFERIORITY|"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.~IDegLira minus IDeg"|Treatment Contrast|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36|||ANCOVA||IDegLira minus IDeg|||-0.36|-0.58|
91758635|NCT01336023|183410583|SUPERIORITY|"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.~IDegLira minus Liraglutide"|Treatment contrast|-0.64|||||TWO_SIDED|95.0|-0.75|-0.53|||ANCOVA||IDegLira minus Liraglutide|||-0.53|-0.75|
91758636|NCT00767819|183410618|SUPERIORITY|The lower limit of the confidence interval was used to support the decision in favor of p0 or p1: if the lower limit of the confidence interval overlapped p0, the hypothesis that p is greater than or equal to p1 could be rejected; on the other side, if the lower limit of the confidence interval excluded p0, the hypothesis that p is greater than or equal to p1 could be accepted.|percentage of participants|40.5||||0.1|TWO_SIDED|80.0|29.5|52.4|||Clopper-Person confidence interval|||||52.4|29.5|0.1
91758637|NCT03916081|183410624|SUPERIORITY||LS Mean Difference vs Vehicle|-1.18||||0.356|TWO_SIDED|95.0|-2.983|0.619||MMRM = mixed effects model for repeated measures vIGA-AD = validated Investigator Global Assessment scale for Atopic Dermatitis|MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.619|-2.983|0.356
91535403|NCT03068468|182949024|SUPERIORITY||Difference|0.0||||0.5701|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CGI-S as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.5701
91535404|NCT03068468|182949025|SUPERIORITY||Difference|0.9||||0.0517|TWO_SIDED|95.0|0.0|1.8|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Phonemic Fluency Test as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Phonemic Fluency Test, baseline Phonemic Fluency Test by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.8|-0.0|0.0517
91535405|NCT03068468|182949026|SUPERIORITY||Difference|0.9||||0.0387|TWO_SIDED|95.0|0.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Letter Number Sequence as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Letter Number Sequence, baseline Letter Number Sequence by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|0.0|0.0387
91535406|NCT03068468|182949027|SUPERIORITY||Difference|0.1||||0.9815|TWO_SIDED|95.0|-8.1|8.3|||MMRM|||Color Trails Test 1: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color trails Test 1 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 1, baseline Color Trails Test 1 by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||8.3|-8.1|0.9815
91535407|NCT03068468|182949027|SUPERIORITY||Difference|0.0||||0.9869|TWO_SIDED|95.0|-5.7|5.6|||MMRM|||Color Trails Test 2: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color Trails Test 2 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 2, baseline Color Trails Test 2 by time interaction, and region.||5.6|-5.7|0.9869
91535408|NCT03068468|182949028|SUPERIORITY||Difference|0.5||||0.1763|TWO_SIDED|95.0|-0.2|1.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MoCA as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MoCA, baseline MoCA by time interaction,baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.2|-0.2|0.1763
91535409|NCT03068468|182949030|SUPERIORITY||Difference|-0.021||||0.9527|TWO_SIDED|95.0|-0.726|0.684|||MMRM|||Ventricles Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.684|-0.726|0.9527
91535410|NCT03068468|182949030|SUPERIORITY||Difference|-0.514||||0.7357|TWO_SIDED|95.0|-3.506|2.478|||MMRM|||Whole Brain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.478|-3.506|0.7357
91535411|NCT03068468|182949030|SUPERIORITY||Difference|-0.004||||0.6439|TWO_SIDED|95.0|-0.023|0.014|||MMRM|||Midbrain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.014|-0.023|0.6439
91535412|NCT03068468|182949030|SUPERIORITY||Difference|0.0||||0.9864|TWO_SIDED|95.0|-0.039|0.04|||MMRM|||Pons Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.040|-0.039|0.9864
91535413|NCT03068468|182949030|SUPERIORITY||Difference|0.001||||0.7529|TWO_SIDED|95.0|-0.004|0.006|||MMRM|||Cerebellar Peduncle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.006|-0.004|0.7529
91535414|NCT03068468|182949030|SUPERIORITY||Difference|0.006||||0.685|TWO_SIDED|95.0|-0.025|0.038|||MMRM|||Third Ventricle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.038|-0.025|0.6850
91758638|NCT03916081|183410624|SUPERIORITY||LS Mean Difference vs Vehicle|-1.6||||0.097|TWO_SIDED|95.0|-3.382|0.178|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.178|-3.382|0.097
91535415|NCT03068468|182949030|SUPERIORITY||Difference|-0.041||||0.9|TWO_SIDED|95.0|-0.68|0.598|||MMRM|||Frontal Lobe Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.598|-0.680|0.9000
91535416|NCT02085356|182949031|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|||||||||||||
91535417|NCT02085356|182949032|OTHER||Odds Ratio (OR)|0.32|||||TWO_SIDED|||||||||||||
91535418|NCT02085356|182949033|OTHER|||||||0.605|||||||Mixed Models Analysis|||||||0.605
91535419|NCT02085356|182949034|OTHER|||||||0.902|||||||Chi-squared|||Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.||||0.902
91535420|NCT02085356|182949035|OTHER|||||||0.869|||||||Mixed Models Analysis|||||||0.869
91535421|NCT02085356|182949035|OTHER||Odds Ratio (OR)|0.32||||0.982|TWO_SIDED||||||Mixed Models Analysis|||||||0.982
91535422|NCT01606124|182949082|SUPERIORITY|||||||0.5631|||||||Wilcoxon (Mann-Whitney)|||||||0.5631
91535423|NCT01606124|182949083|SUPERIORITY|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||||||0.1439
91535424|NCT02263508|182949147|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.04|0.71|0.13
91535425|NCT02263508|182949148|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.77|1.21|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.21|0.77|0.77
91535426|NCT02263508|182949156|OTHER||Odds Ratio (OR)|1.88||||0.012|TWO_SIDED|95.0|1.15|3.07|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||3.07|1.15|0.012
91535427|NCT02263508|182949157|OTHER||Hazard Ratio (HR)|1.05||||0.14|TWO_SIDED|95.0|0.82|1.34|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.34|0.82|0.14
91535428|NCT02263508|182949158|OTHER||Hazard Ratio (HR)|0.88||||0.47|TWO_SIDED|95.0|0.63|1.24|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.24|0.63|0.47
91758639|NCT03916081|183410625|SUPERIORITY||LS Mean Difference|-11.37||||0.248|TWO_SIDED|95.0|-26.789|4.044|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||4.044|-26.789|0.248
91758640|NCT03916081|183410625|SUPERIORITY||LS Mean Difference|-10.28||||0.349|TWO_SIDED|95.0|-25.666|5.114|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||5.114|-25.666|0.349
91758641|NCT03916081|183410625|SUPERIORITY||LS Mean Difference|-5.82||||0.912|TWO_SIDED|-22.52|-22.52|10.88|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||10.880|-22.520|0.912
91758642|NCT03916081|183410625|SUPERIORITY||LS Mean Difference|-9.17||||0.548|TWO_SIDED|95.0|-25.686|7.341|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||7.341|-25.686|0.548
91758643|NCT03916081|183410625|SUPERIORITY||LS Mean Difference|-13.53||||0.164|TWO_SIDED|95.0|-30.157|3.097|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||3.097|-30.157|0.164
91758644|NCT03916081|183410625|SUPERIORITY||LS Mean Difference|-16.48||||0.049|TWO_SIDED|95.0|-32.921|-0.048|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||-0.048|-32.921|0.049
91758645|NCT03916081|183410626|SUPERIORITY||LS Mean Difference|-0.92||||0.44|TWO_SIDED|95.0|-2.412|0.568|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.568|-2.412|0.440
91758646|NCT03916081|183410626|SUPERIORITY||LS Mean Difference|-0.57||||0.875|TWO_SIDED|95.0|-2.061|0.914|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.914|-2.061|0.875
91758647|NCT03916081|183410627|SUPERIORITY|||||||0.352|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.352
91758648|NCT03916081|183410627|SUPERIORITY|||||||0.803|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.803
91758649|NCT03916081|183410627|SUPERIORITY|||||||0.25|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.250
91758650|NCT03916081|183410627|SUPERIORITY|||||||0.756|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.756
91758651|NCT03916081|183410627|SUPERIORITY|||||||0.097|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.097
91758652|NCT03916081|183410627|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.054
91758653|NCT03916081|183410628|SUPERIORITY|||||||0.178|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.178
91758654|NCT03916081|183410628|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.046
91758655|NCT03916081|183410628|SUPERIORITY|||||||0.469|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.469
91758656|NCT03916081|183410628|SUPERIORITY|||||||0.446|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.446
91535429|NCT02263508|182949159|OTHER||Odds Ratio (OR)|1.32||||0.081|TWO_SIDED|95.0|0.97|1.79|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.79|0.97|0.081
91535430|NCT02263508|182949161|OTHER||Odds Ratio (OR)|1.39||||0.039|TWO_SIDED|95.0|1.02|1.9|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.90|1.02|0.039
91535431|NCT02263508|182949163|OTHER||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.75|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.75|0.94|0.11
91535432|NCT02263508|182949164|OTHER||Odds Ratio (OR)|1.44||||0.02|TWO_SIDED|95.0|1.06|1.96|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.96|1.06|0.020
91535433|NCT02263508|182949166|OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||2.17|1.16|0.004
91535434|NCT02263508|182949168|OTHER||Odds Ratio (OR)|1.35||||0.058|TWO_SIDED|95.0|0.99|1.85|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.85|0.99|0.058
91758657|NCT03916081|183410628|SUPERIORITY|||||||0.009|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.009
91758658|NCT03916081|183410628|SUPERIORITY|||||||0.045|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.045
91758659|NCT03916081|183410629|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.317
91758660|NCT03916081|183410629|SUPERIORITY|||||||0.182|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.182
91758661|NCT03916081|183410629|SUPERIORITY|||||||0.485|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.485
91758662|NCT03916081|183410629|SUPERIORITY|||||||0.913|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.913
91758663|NCT03916081|183410629|SUPERIORITY|||||||0.288|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.288
91758664|NCT03916081|183410630|SUPERIORITY|||||||0.34|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.340
91758665|NCT03916081|183410630|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.146
91513096|NCT01172938|182897797|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7||||0.0504|TWO_SIDED|95.0|0.0|3.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.40|-0.00|0.0504
91513097|NCT01172938|182897798|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0017|TWO_SIDED|95.0|6.6|26.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.6|0.0017
91513098|NCT01172938|182897798|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-1.2|18.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-1.2|
91513099|NCT01172938|182897799|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.9||||0.0023|TWO_SIDED|95.0|-12.9|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.8|-12.9|0.0023
91513100|NCT01172938|182897799|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.8|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.7|-10.8|
91513101|NCT01172938|182897800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.2|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.2|
91513102|NCT01172938|182897800|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
91513103|NCT01172938|182897801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.1|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.1|
91513104|NCT01172938|182897801|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
91513105|NCT01172938|182897802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.88|||||TWO_SIDED|95.0|-7.41|-2.34|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.34|-7.41|
91758666|NCT03916081|183410630|SUPERIORITY|||||||0.967|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.967
91513106|NCT01172938|182897802|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.39|||||TWO_SIDED|95.0|-6.92|-1.86|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.86|-6.92|
91513107|NCT01172938|182897803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-0.76|-0.31|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.31|-0.76|
91513108|NCT01172938|182897803|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.7|-0.25|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.25|-0.70|
91513109|NCT01172938|182897804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.33|||||TWO_SIDED|95.0|0.43|4.23|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.23|0.43|
91513110|NCT01172938|182897804|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|||||TWO_SIDED|95.0|-1.77|2.03|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.03|-1.77|
91513111|NCT01172938|182897805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.56|||||TWO_SIDED|95.0|1.72|5.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||5.40|1.72|
91513112|NCT01172938|182897805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.04|||||TWO_SIDED|95.0|0.21|3.88|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||3.88|0.21|
91513113|NCT01172938|182897806|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|24.6|||||TWO_SIDED|95.0|15.2|34.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||34.0|15.2|
91513114|NCT01172938|182897806|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4|||||TWO_SIDED|95.0|3.4|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|3.4|
91513115|NCT01172938|182897807|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-10.6|||||TWO_SIDED|95.0|-15.4|-5.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-5.7|-15.4|
91513116|NCT01172938|182897807|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.1|||||TWO_SIDED|95.0|-12.0|-2.2|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.2|-12.0|
91513117|NCT01172938|182897808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|||||TWO_SIDED|95.0|-1.6|0.0|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.0|-1.6|
91535435|NCT02263508|182949169|OTHER||Difference|0.19|STANDARD_ERROR_OF_MEAN|0.95||0.84|TWO_SIDED|95.0|-1.67|2.05|||Mixed Model for Repeated Measures|||Mixed Model for Repeated Measures include the fixed and categorical effects of treatment, visit and treatment-by-visit interaction, the fixed and continuous covariates of baseline HRQL score, randomization stratification factors (stage of disease and prior BRAF inhibitor therapy per IVRS) and baseline PD-L1 status (positive and not positive). Random subject effect was modeled using within subject-error correlation structure.||2.05|-1.67|0.84
91535436|NCT01149681|182949179|SUPERIORITY|||||||0.2364|||||||Repeated measures analysis|||||||0.2364
91535437|NCT01803646|182949187|SUPERIORITY||Mean Difference (Net)|-0.17||||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||||0.17|-0.51|0.32
91535438|NCT01803646|182949188|SUPERIORITY||Mean Difference (Net)|-0.79||||0.63|TWO_SIDED|95.0|-4.0|2.4|||Mixed Models Analysis|||||2.4|-4|0.63
91535439|NCT01803646|182949189|SUPERIORITY|||||||0.821|||||||Fisher Exact|||Analysis for air conduction||||0.821
91535440|NCT01803646|182949189|SUPERIORITY|||||||1|||||||Fisher Exact|||Analysis for bone conduction||||1.0
91535441|NCT01167426|182949190|SUPERIORITY_OR_OTHER||Difference in mean ranks|79.6|||<|0.0001||95.0|||||Wilcoxon Signed-Rank||Difference in mean ranks between Week 2 and Week 6|Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).||||<0.0001
91535442|NCT01167426|182949191|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.|Chi-squared|||||||<0.0001
91758667|NCT03916081|183410630|SUPERIORITY|||||||0.088|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.088
91758668|NCT03916081|183410631|SUPERIORITY||LS Mean Difference|0.38||||0.989|TWO_SIDED|95.0|-1.098|1.852|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||1.852|-1.098|0.989
91758669|NCT03916081|183410631|SUPERIORITY||LS Mean Difference|-0.1|||>|0.999|TWO_SIDED|95.0|-1.566|1.367|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||1.367|-1.566|>0.999
91758670|NCT03916081|183410631|SUPERIORITY||LS Mean Difference|0.6||||0.966|TWO_SIDED|95.0|-1.51|2.702|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||2.702|-1.510|0.966
91535443|NCT02020018|182949222|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
91535444|NCT04044664|182949225|OTHER|||||||0.1728|||||||t-test, 1 sided|||CAPS-5 Total Score||||0.1728
91535445|NCT04044664|182949225|OTHER|||||||0.0962|||||||t-test, 1 sided|||Cognition and Mood sub-score||||0.0962
91535446|NCT04044664|182949225|OTHER|||||||0.0191|||||||t-test, 1 sided|||Arousal and Reactivity sub-score||||0.0191
91535447|NCT04044664|182949231|OTHER|||||||0.0452|||||||t-test, 1 sided|||||||0.0452
91535448|NCT04044664|182949231|OTHER|||||||0.0614|||||||t-test, 1 sided|||||||0.0614
91535449|NCT04044664|182949232|OTHER|||||||0.0182|||||||t-test, 1 sided|||greater than or equal to 30% decrease from baseline||||0.0182
91758671|NCT03916081|183410631|SUPERIORITY||LS Mean Difference|-0.34||||0.999|TWO_SIDED|95.0|-2.415|1.744|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||1.744|-2.415|0.999
91535450|NCT04044664|182949232|OTHER|||||||0.0705|||||||t-test, 1 sided|||greater than or equal to 50% decrease from baseline||||0.0705
91535451|NCT00478556|182949239|SUPERIORITY_OR_OTHER||difference in proportions|62.0|||<|0.001|||||||Binomial test of proportion|tested if values were different from 50%||All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.||||<0.001
91535452|NCT00478556|182949240|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.||||0.270
91535453|NCT03736785|182949242|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
91535454|NCT03736785|182949242|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
91535455|NCT03736785|182949242|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
91535456|NCT03736785|182949243|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.08|||||TWO_SIDED|90.0|-0.11|0.28|||Mixed Models Analysis|||||0.28|-0.11|
91535457|NCT03736785|182949243|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.09|||||TWO_SIDED|90.0|-0.1|0.29|||Mixed Models Analysis|||||0.29|-0.10|
91535458|NCT02974010|182949255|SUPERIORITY|||||||0.03||||||BDM LS difference overall|Mixed Models Analysis|BDM LS difference overall||||||.03
91535459|NCT03852433|182949322|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
91535460|NCT03852433|182949322|OTHER||Difference in percentages|15.3||||0.2631|TWO_SIDED|95.0|-8.2|34.2|||Fisher Exact|||||34.2|-8.2|0.2631
91535461|NCT03852433|182949322|OTHER||Difference in percentages|29.3||||0.0197|TWO_SIDED|95.0|1.8|48.2|||Fisher Exact|||||48.2|1.8|0.0197
91535462|NCT03852433|182949322|OTHER||Difference in percentages|-4.7||||0.7186|TWO_SIDED|95.0|-26.3|11.8|||Fisher Exact|||||11.8|-26.3|0.7186
91535463|NCT03852433|182949322|OTHER||Difference in percentages|14.0||||0.2184|TWO_SIDED|95.0|-5.5|32.7|||Fisher Exact|||||32.7|-5.5|0.2184
91535464|NCT03852433|182949322|OTHER||Difference in percentages|-20.0||||0.0283|TWO_SIDED|95.0|-36.1|-3.5|||Fisher Exact|||||-3.5|-36.1|0.0283
91535465|NCT03852433|182949325|OTHER||Difference in percentages|26.0||||0.0134|TWO_SIDED|95.0|6.0|44.0|||Fisher Exact|||||44.0|6.0|0.0134
91535466|NCT03852433|182949326|OTHER||Difference in percentages|28.0||||0.0049|TWO_SIDED|95.0|8.2|45.1|||Fisher Exact|||||45.1|8.2|0.0049
91535467|NCT03852433|182949327|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
91535468|NCT03852433|182949327|OTHER||Difference in percentages|1.0||||1|TWO_SIDED|95.0|-22.8|21.4|||Fisher Exact|||||21.4|-22.8|1.0000
91535469|NCT03852433|182949327|OTHER||Difference in percentages|21.0||||0.1265|TWO_SIDED|95.0|-5.3|42.2|||Fisher Exact|||||42.2|-5.3|0.1265
91535470|NCT03852433|182949327|OTHER||Difference in percentages|-13.0||||0.1863|TWO_SIDED|95.0|-35.3|5.4|||Fisher Exact|||||5.4|-35.3|0.1863
91535471|NCT03852433|182949327|OTHER||Difference in percentages|20.0||||0.0601|TWO_SIDED|95.0|1.0|38.2|||Fisher Exact|||||38.2|1.0|0.0601
91535472|NCT03852433|182949327|OTHER||Difference in percentages|-14.0||||0.1247|TWO_SIDED|95.0|-29.9|1.7|||Fisher Exact|||||1.7|-29.9|0.1247
91535473|NCT03852433|182949328|OTHER||Difference in LS Mean|1.56||||0.0717|TWO_SIDED|95.0|-0.14|3.26|||MMRM|||||3.26|-0.14|0.0717
91535474|NCT03852433|182949328|OTHER||Difference in LS Mean|-1.84||||0.1563|TWO_SIDED|95.0|-4.39|0.71|||MMRM|||||0.71|-4.39|0.1563
91758672|NCT03916081|183410631|SUPERIORITY||LS Mean Difference|-0.25|||>|0.999|TWO_SIDED|95.0|-2.624|2.119|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||2.119|-2.624|>0.999
91758673|NCT03916081|183410631|SUPERIORITY||LS Mean Difference|-0.94||||0.798|TWO_SIDED|95.0|-3.285|1.398|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.398|-3.285|0.798
91535475|NCT03852433|182949328|OTHER||Difference in LS Mean|-1.8||||0.1626|TWO_SIDED|95.0|-4.33|0.73|||MMRM|||||0.73|-4.33|0.1626
91535476|NCT03852433|182949328|OTHER||Difference in LS Mean|-3.34||||0.0099|TWO_SIDED|95.0|-5.87|-0.82|||MMRM|||||-0.82|-5.87|0.0099
91535477|NCT03852433|182949328|OTHER||Difference in LS Mean|0.07||||0.9384|TWO_SIDED|95.0|-1.67|1.81|||MMRM|||||1.81|-1.67|0.9384
91535478|NCT03852433|182949328|OTHER||Difference in LS Mean|-1.49||||0.0875|TWO_SIDED|95.0|-3.2|0.22|||MMRM|||||0.22|-3.20|0.0875
91535479|NCT03852433|182949329|OTHER||Difference in LS Mean|0.15||||0.8645|TWO_SIDED|95.0|-1.54|1.83|||MMRM|||||1.83|-1.54|0.8645
91535480|NCT03852433|182949329|OTHER||Difference in LS Mean|-0.33||||0.7033|TWO_SIDED|95.0|-2.06|1.39|||MMRM|||||1.39|-2.06|0.7033
91535481|NCT03852433|182949329|OTHER||Difference in LS Mean|-0.48||||0.5806|TWO_SIDED|95.0|-2.18|1.23|||MMRM|||||1.23|-2.18|0.5806
91535482|NCT03852433|182949330|OTHER||Difference in LS Mean|-1.68||||0.1103|TWO_SIDED|95.0|-3.75|0.39|||MMRM|||||0.39|-3.75|0.1103
91535483|NCT03852433|182949330|OTHER||Difference in LS Mean|-2.05||||0.1533|TWO_SIDED|95.0|-4.88|0.77|||MMRM|||||0.77|-4.88|0.1533
91535484|NCT03852433|182949330|OTHER||Difference in LS Mean|-2.22||||0.1129|TWO_SIDED|95.0|-4.98|0.53|||MMRM|||||0.53|-4.98|0.1129
91535485|NCT03852433|182949330|OTHER||Difference in LS Mean|-0.58||||0.6753|TWO_SIDED|95.0|-3.34|2.17|||MMRM|||||2.17|-3.34|0.6753
91535486|NCT03852433|182949330|OTHER||Difference in LS Mean|-0.12||||0.9124|TWO_SIDED|95.0|-2.28|2.04|||MMRM|||||2.04|-2.28|0.9124
91535487|NCT03852433|182949330|OTHER||Difference in LS Mean|1.56||||0.1526|TWO_SIDED|95.0|-0.59|3.7|||MMRM|||||3.70|-0.59|0.1526
91535488|NCT02929069|182949337|SUPERIORITY||Risk Ratio (RR)|0.88||||0.52|TWO_SIDED|95.0|0.52|1.25|||Regression, Logistic|||||1.25|.52|0.52
91535489|NCT00389519|182949412|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||two-sided test|ANCOVA|test from contrast statement from full model||"Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.~If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis."||||0.044
91535490|NCT00389519|182949413|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||two-sided, unadjusted|ANCOVA|test from contrast statement from full model||||||0.006
91535491|NCT03425539|182949432|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and enzyme replacement therapy (ERT) treatment status), and the treatment group.|LS Mean difference vs. placebo|0.42||||0.3189|TWO_SIDED|95.0|-0.4|1.23|||ANCOVA|||||1.23|-0.4|0.3189
91535492|NCT03425539|182949433|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|-873.53|||<|0.0001|TWO_SIDED|95.0|-1097.53|-649.53|||ANCOVA|||||-649.53|-1097.53|<0.0001
91535493|NCT03425539|182949434|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the terms value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|0.31||||0.4676|TWO_SIDED|95.0|-0.53|1.16|||ANCOVA|||||1.16|-0.53|0.4676
91535494|NCT03425539|182949435|OTHER||Win ratio|1.0||||0.8986|TWO_SIDED|95.0|0.57|1.89|||ANCOVA|||The p-value was derived from a rank ANCOVA adjusted for the baseline value and stratified by sex and ERT treatment status.||1.89|0.57|0.8986
91535495|NCT00946192|182949442|OTHER|Least square means||||||0.039|||||||Mixed Models Analysis|||||||0.039
91535496|NCT00946192|182949443|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
91535497|NCT02014558|182949479|OTHER||Slope|0.99|||||TWO_SIDED|90.0|0.788|1.19||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||1.19|0.788|
91535498|NCT02014558|182949479|OTHER||Slope|1.22|||||TWO_SIDED|90.0|1.0|1.43||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.43|1.00|
91513118|NCT01172938|182897808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|-0.8|||||TWO_SIDED|95.0|-1.6|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.6|
91513119|NCT01172938|182897809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.2|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.2|
91513120|NCT01172938|182897809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.5|
91513121|NCT01172938|182897810|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-6.38|||||TWO_SIDED|95.0|-9.0|-3.75|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-3.75|-9.00|
91513122|NCT01172938|182897810|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-4.41|||||TWO_SIDED|95.0|-7.03|-1.79|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.79|-7.03|
91513123|NCT01172938|182897811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-0.94|-0.46|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.46|-0.94|
91513124|NCT01172938|182897811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||||TWO_SIDED|95.0|-0.7|-0.22|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.22|-0.70|
91513125|NCT01172938|182897812|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|2.21|||||TWO_SIDED|95.0|0.32|4.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.10|0.32|
91513126|NCT01172938|182897812|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.4|||||TWO_SIDED|95.0|-1.5|2.29|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.29|-1.50|
91513127|NCT01172938|182897813|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.3|||||TWO_SIDED|95.0|-10.1|16.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.7|-10.1|
91513128|NCT01172938|182897813|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.3|||||TWO_SIDED|95.0|-6.5|21.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.1|-6.5|
91513129|NCT01172938|182897814|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.9|||||TWO_SIDED|95.0|-13.4|19.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-13.4|
91513130|NCT01172938|182897814|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-9.1|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-9.1|
91513131|NCT01172938|182897815|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.2|||||TWO_SIDED|95.0|9.0|29.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||29.3|9.0|
91513132|NCT01172938|182897815|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.6|||||TWO_SIDED|95.0|6.4|26.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.4|
91513133|NCT01172938|182897816|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.2|||||TWO_SIDED|95.0|-0.1|26.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.5|-0.1|
91513134|NCT01172938|182897816|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3|||||TWO_SIDED|95.0|-2.4|25.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.0|-2.4|
91513135|NCT01172938|182897817|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-6.8|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-6.8|
91513136|NCT01172938|182897817|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-8.7|24.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.2|-8.7|
91513137|NCT01172938|182897818|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|26.3|||||TWO_SIDED|95.0|17.1|35.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||35.5|17.1|
91513138|NCT01172938|182897818|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.2|||||TWO_SIDED|95.0|5.4|23.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.1|5.4|
91513139|NCT01172938|182897819|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.3|||||TWO_SIDED|95.0|3.7|16.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.8|3.7|
91535499|NCT02014558|182949480|OTHER||Slope|0.808|||||TWO_SIDED|90.0|0.629|0.988||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||0.988|0.629|
91535500|NCT02014558|182949480|OTHER||Slope|1.21|||||TWO_SIDED|90.0|1.02|1.41||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.41|1.02|
91535501|NCT02014558|182949518|OTHER||Geometric LS Mean Ratio|109.46|||||TWO_SIDED|90.0|49.82|240.48||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||240.48|49.82|
91535502|NCT02014558|182949519|OTHER||Geometric LS Mean Ratio|149.9||||||90.0|74.88|300.06||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||300.06|74.88|
91535503|NCT02014558|182949520|OTHER||Geometric LS Mean Ratio|111.64|||||TWO_SIDED|90.0|69.54|179.25||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||179.25|69.54|
91535504|NCT02014558|182949521|OTHER||Geometric LS Mean Ratio|123.47|||||TWO_SIDED|90.0|72.41|210.52||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||210.52|72.41|
91535505|NCT02014558|182949526|OTHER||Geometric LS Mean Ratio|93.96|||||TWO_SIDED|90.0|75.29|117.26||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||117.26|75.29|
91535506|NCT02014558|182949527|OTHER||Geometric LS Mean Ratio|91.46|||||TWO_SIDED|90.0|74.6|112.12||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||112.12|74.60|
91535507|NCT02014558|182949528|OTHER||Geometric LS Mean Ratio|97.71|||||TWO_SIDED|90.0|74.19|128.7||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||128.70|74.19|
91535508|NCT02014558|182949531|OTHER||Geometric LS Mean Ratio|106.42|||||TWO_SIDED|90.0|85.28|132.81||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||132.81|85.28|
91535509|NCT02014558|182949533|OTHER||Geometric LS Mean Ratio|83.93|||||TWO_SIDED|90.0|46.53|151.39||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||151.39|46.53|
91535510|NCT02014558|182949535|OTHER||Geometric LS Mean Ratio|82.84|||||TWO_SIDED|90.0|40.25|170.48||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||170.48|40.25|
91535511|NCT05273801|182949536|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||How frequently clinician ask about RPE/HR during session||||0.73
91535512|NCT05273801|182949536|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||How frequently education provided regarding HR/RPE during session||||0.05
91535513|NCT05273801|182949536|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||How frequently HR/RPE target is mentioned in session||||0.007
91535514|NCT05273801|182949536|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||How frequently clinician modifies session/task to reach HR/RPE target||||0.005
91758674|NCT03916081|183410632|SUPERIORITY||LS Mean Difference|-0.78||||0.466|TWO_SIDED|95.0|-2.075|0.506|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||0.506|-2.075|0.466
91535515|NCT05273801|182949536|SUPERIORITY|||||||1e-05|||||||t-test, 2 sided|||How frequently clinicians monitor HR/RPE during session||||0.00001
91535516|NCT04159506|182949554|SUPERIORITY||Median Difference (Final Values)|0.63|||<|0.05|TWO_SIDED|||||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.|Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||||||<0.05
91535517|NCT04159506|182949555|SUPERIORITY||Median Difference (Final Values)|0.31|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
91513140|NCT01172938|182897819|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.0|3.0|
91513141|NCT01172938|182897820|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.1|||||TWO_SIDED|95.0|-0.4|6.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.5|-0.4|
91758675|NCT03916081|183410632|SUPERIORITY||LS Mean Difference|-1.03||||0.18|TWO_SIDED|95.0|-2.322|0.255|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||0.255|-2.322|0.180
91758676|NCT03916081|183410632|SUPERIORITY||LS Mean Difference|-0.43||||0.967|TWO_SIDED|95.0|-1.921|1.069|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||1.069|-1.921|0.967
91758677|NCT03916081|183410632|SUPERIORITY||LS Mean Difference|-0.72||||0.684|TWO_SIDED|95.0|-2.205|0.762|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||0.762|-2.205|0.684
91758678|NCT03916081|183410632|SUPERIORITY||LS Mean Difference|-0.61||||0.856|TWO_SIDED|95.0|-2.221|1.003|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||1.003|-2.221|0.856
91758679|NCT03916081|183410632|SUPERIORITY||LS Mean Difference|-0.51||||0.932|TWO_SIDED|95.0|-2.105|1.089|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.089|-2.105|0.932
91758680|NCT03916081|183410633|SUPERIORITY|||||||0.637|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.637
91758681|NCT03916081|183410633|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.124
91758682|NCT03916081|183410633|SUPERIORITY|||||||0.196|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.196
91758683|NCT03916081|183410633|SUPERIORITY|||||||0.985|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.985
91758684|NCT03916081|183410633|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.401
91758685|NCT03916081|183410633|SUPERIORITY|||||||0.996|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.996
91758686|NCT00235716|183410634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.15||||0.03|TWO_SIDED|95.0|0.92|5.39||p-value adjusted for 6 treatment group comparisons.|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||5.39|0.92|0.03
91758687|NCT00235716|183410634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.98||||0.4|TWO_SIDED|95.0|-0.24|4.2||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.20|-0.24|0.40
91758688|NCT00235716|183410634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.49|TWO_SIDED|95.0|-0.48|4.0||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.00|-0.48|0.49
91759944|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.06|||||TWO_SIDED|95.0|-16.44|-1.68||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-16.44|
91513142|NCT01172938|182897820|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.8|||||TWO_SIDED|95.0|0.8|8.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.7|0.8|
91758689|NCT00235716|183410634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.6|TWO_SIDED|95.0|-3.63|0.85||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.85|-3.63|0.60
91758690|NCT00235716|183410634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.85|TWO_SIDED|95.0|-2.44|2.01||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||2.01|-2.44|0.85
91759945|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44|||||TWO_SIDED|95.0|-21.82|-7.06||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.06|-21.82|
91513143|NCT01172938|182897821|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9|||||TWO_SIDED|95.0|8.3|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|8.3|
91513144|NCT01172938|182897821|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.1|||||TWO_SIDED|95.0|4.0|16.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|4.0|
91513145|NCT01172938|182897822|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|4.8|14.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.2|4.8|
91513146|NCT01172938|182897822|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.7|||||TWO_SIDED|95.0|1.2|8.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.3|1.2|
91513147|NCT01172938|182897823|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.6|||||TWO_SIDED|95.0|-2.8|17.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.9|-2.8|
91513148|NCT01172938|182897823|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.9|||||TWO_SIDED|95.0|0.8|23.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.0|0.8|
91513149|NCT01172938|182897824|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-1.4|||||TWO_SIDED|95.0|-17.7|14.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.8|-17.7|
91513150|NCT01172938|182897824|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.4|||||TWO_SIDED|95.0|-14.8|19.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.6|-14.8|
91513151|NCT01172938|182897825|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.4|||||TWO_SIDED|95.0|6.6|28.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||28.2|6.6|
91513152|NCT01172938|182897825|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.8|||||TWO_SIDED|95.0|5.6|27.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|5.6|
91513153|NCT01172938|182897826|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|5.8|||||TWO_SIDED|95.0|-10.7|22.4|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-10.7|
91513154|NCT01172938|182897826|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.8|||||TWO_SIDED|95.0|-8.5|26.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.2|-8.5|
91513155|NCT00844194|182897852|SUPERIORITY_OR_OTHER||LSmean|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.1|||ANCOVA|with last observation carried forward (LOCF)||||-1.10|-1.89|< 0.0001
91513156|NCT00844194|182897852|SUPERIORITY_OR_OTHER||LSmean|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.04|||ANCOVA|||||-1.04|-2.30|< 0.0001
91513157|NCT00701389|182897951|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.|Difference in Least Squares Means|1.5|||||TWO_SIDED|90.0|0.0|3.0|||Mixed Effect Model|||100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo||3.0|0.0|
91513158|NCT00701389|182897952|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.2|||||TWO_SIDED|90.0|-0.2|2.7|||Mixed Effect Model|||sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo||2.7|-0.2|
91513159|NCT04808609|182897959|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|1.63||0.77|TWO_SIDED|95.0|0.24|6.76|||Fisher Exact|||||6.76|0.24|0.77
91535518|NCT04159506|182949556|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
91535519|NCT05570006|182949570|SUPERIORITY||Difference in proportion|7.4|||||ONE_SIDED|||||Bayesian method||||Compared to historical placebo||||
91535520|NCT01875250|182949637|SUPERIORITY|||||||0.74|||||||Wilcoxon rank sum tests|||||||0.74
91535521|NCT00739102|182949668|SUPERIORITY_OR_OTHER||Proportion - 12-month patency rate|0.665|STANDARD_ERROR_OF_MEAN|0.032||0.437|TWO_SIDED|95.0|0.6|0.725||The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.|Agresti-Coull method||The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method|The null hypothesis to be tested was Ho: P = 0.66 against Ha: P \> 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.||0.725|0.6|0.437
91535522|NCT00739102|182949670|SUPERIORITY_OR_OTHER||Death Rate (%)|2.1|||||TWO_SIDED|95.0|0.7|4.9||||||||4.9|0.7|
91535523|NCT00739102|182949671|SUPERIORITY_OR_OTHER||Index Limb Amputation Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
91535524|NCT00739102|182949672|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
91535525|NCT00739102|182949673|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|13.6|||||TWO_SIDED|95.0|9.5|18.6||||||||18.6|9.5|
91535526|NCT00739102|182949674|SUPERIORITY_OR_OTHER||Stent Fracture Rate (%)|1.5|||||TWO_SIDED|95.0|0.3|4.4||||||||4.4|0.3|
91535527|NCT00739102|182949675|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|5.6||||||95.0||||||||||||
91535528|NCT00739102|182949676|SUPERIORITY_OR_OTHER||Primary safety endpoint rate (%)|100.0|||<|0.001|TWO_SIDED|95.0|98.2|100.0|||Agresti-Coull method|||The null hypothesis to be tested was Ho: P = 0.88 against Ha: P \> 0.88, where 0.88 was the Objective Performance Criteria (OPC).||100|98.2|<0.001
91535529|NCT00739102|182949677|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|8.4||||||95.0||||||||||||
91535530|NCT00739102|182949680|SUPERIORITY_OR_OTHER||Major adverse event rate (%)|14.4|||||TWO_SIDED|95.0|10.2|19.5||||||||19.5|10.2|
91535531|NCT00991276|182949742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.1|STANDARD_ERROR_OF_MEAN|4.38|<|0.0001|TWO_SIDED|95.0|-35.78|-18.42||This analysis was step 1 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The least squares (LS) means and standard errors (SE) were used to test for a treatment difference and construct 2-sided 95% confidence intervals (CIs). The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.42|-35.78|<0.0001
91535532|NCT00991276|182949742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.93|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-35.54|-18.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.32|-35.54|<0.0001
91535533|NCT00991276|182949742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|4.32||0.9684|TWO_SIDED|95.0|-8.72|8.38||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.38|-8.72|0.9684
91535534|NCT00991276|182949743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.68|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-5.44|-1.92||This analysis was step 2 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.92|-5.44|<0.0001
91535535|NCT00991276|182949743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.88||0.1541|TWO_SIDED|95.0|-0.48|3.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.01|-0.48|0.1541
91535536|NCT00991276|182949743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-6.68|-3.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.21|-6.68|<0.0001
91535537|NCT00991276|182949744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|30.81|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.14|45.49||This analysis was step 3 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||45.49|16.14|<0.0001
91535538|NCT00991276|182949744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.79|STANDARD_ERROR_OF_MEAN|7.34||0.0004|TWO_SIDED|95.0|12.26|41.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||41.32|12.26|0.0004
91535539|NCT00991276|182949744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.03|STANDARD_ERROR_OF_MEAN|7.27||0.5807|TWO_SIDED|95.0|-10.36|18.41||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.41|-10.36|0.5807
91535540|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|2.09||0.0076|TWO_SIDED|95.0|-9.8|-1.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.54|-9.80|0.0076
91535541|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.43|-6.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-6.21|-14.43|<0.0001
91535542|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.65|STANDARD_ERROR_OF_MEAN|2.06||0.0257|TWO_SIDED|95.0|0.58|8.73||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.73|0.58|0.0257
91535543|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|6.05||0.0003|TWO_SIDED|95.0|10.74|34.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||34.67|10.74|0.0003
91535544|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|6.0||0.0174|TWO_SIDED|95.0|-26.35|-2.59||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.59|-26.35|0.0174
91758691|NCT00235716|183410634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.6|TWO_SIDED|95.0|-1.04|3.39||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.39|-1.04|0.60
91758692|NCT00235716|183410635|SUPERIORITY_OR_OTHER|||||||0.69||||||p- value is unadjusted for multiple comparisons because its a 3 degrees of freedom test for any treatment group differences|Log Rank|3 degrees of freedom test||||||0.69
91535545|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|37.17|STANDARD_ERROR_OF_MEAN|5.96|<|0.0001|TWO_SIDED|95.0|25.38|48.96||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||48.96|25.38|<0.0001
91759946|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.72|||||TWO_SIDED|95.0|-12.53|3.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.09|-12.53|
91513160|NCT04808609|182897960|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED|95.0|0.43|3.78|||Chi-squared|||||3.78|0.43|0.66
91513161|NCT04808609|182897961|OTHER|feasibility test|Cohen's D|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.59|TWO_SIDED|95.0|-0.44|0.86|||t-test, 2 sided|||||0.86|-0.44|0.59
91513162|NCT04808609|182897961|OTHER|feasibility|Cohen's D|0.41|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|0.07|0.74|||t-test, 1 sided|||Results from Paired T-Test assessing the with-subject time effect on exhaled CO in ppm from baseline to 12 weeks||0.74|0.07|0.02
91513163|NCT04808609|182897962|OTHER|feasibility test|Cohen's D|0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.46|0.78|||t-test, 2 sided|||||0.78|-0.46|0.61
91513164|NCT04808609|182897963|OTHER|feasibility test|Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.31||0.55|TWO_SIDED|95.0|-0.42|0.8|||t-test, 2 sided|||||0.80|-0.42|0.55
91513165|NCT04808609|182897964|OTHER|feasibility test|Cohen's D|0.004|STANDARD_ERROR_OF_MEAN|0.31||0.99|TWO_SIDED|95.0|-0.61|0.62|||t-test, 2 sided|||||0.62|-0.61|0.99
91513166|NCT00562159|182897966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.005|TWO_SIDED|95.0|-2.22|-0.4|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.40|-2.22|=0.005
91513167|NCT00562159|182897967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||=|0.015|TWO_SIDED|95.0|-1.46|-0.26|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.26|-1.46|=0.015
91513168|NCT00562159|182897968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||=|0.084|TWO_SIDED|95.0|-0.96|0.06|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.06|-0.96|=0.084
91513169|NCT00562159|182897969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||=|0.022|TWO_SIDED|95.0|-0.48|-0.05|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.05|-0.48|=0.022
91513170|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.6|||||TWO_SIDED|95.0|-12.1|-5.1||||||Serotype 1: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-5.1|-12.1|
91513171|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-15.5|||||TWO_SIDED|95.0|-20.1|-10.8||||||Serotype 3: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-10.8|-20.1|
91513172|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.4|||||TWO_SIDED|95.0|-12.0|-4.9||||||Serotype 4: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.9|-12.0|
91513173|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.3|||||TWO_SIDED|95.0|-7.8|-0.8||||||Serotype 5: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.8|-7.8|
91513174|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-2.4|||||TWO_SIDED|95.0|-4.6|-0.2||||||Serotype 6A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.2|-4.6|
91513175|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.1|||||TWO_SIDED|95.0|-7.0|-1.2||||||Serotype 6B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-1.2|-7.0|
91513176|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.7|0.7||||||Serotype 7F: 2-sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.7|-2.7|
91513177|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.9|||||TWO_SIDED|95.0|-11.3|-4.6||||||Serotype 9V: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.6|-11.3|
91535546|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.93|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|95.0|12.61|29.25||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||29.25|12.61|<0.0001
91535547|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.1|STANDARD_ERROR_OF_MEAN|4.18|<|0.0001|TWO_SIDED|95.0|23.83|40.36||This analysis was step 4 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||40.36|23.83|<0.0001
91535548|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.17|STANDARD_ERROR_OF_MEAN|4.14||0.008|TWO_SIDED|95.0|-19.37|-2.97||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.97|-19.37|0.0080
91535549|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|2.85||0.0834|TWO_SIDED|95.0|-10.61|0.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.67|-10.61|0.0834
91535550|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.59|STANDARD_ERROR_OF_MEAN|2.83|<|0.0001|TWO_SIDED|95.0|12.99|24.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||24.19|12.99|<0.0001
91535551|NCT00991276|182949745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.56|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001|TWO_SIDED|95.0|-29.12|-18.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.01|-29.12|<0.0001
91535552|NCT00991276|182949746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.67|STANDARD_ERROR_OF_MEAN|0.99||0.0077|TWO_SIDED|95.0|-4.63|-0.72||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.72|-4.63|0.0077
91535553|NCT00991276|182949746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.87|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-9.81|-5.93||This analysis was step 5 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.93|-9.81|<0.0001
91758693|NCT00235716|183410636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.84|TWO_SIDED|95.0|-0.54|0.92||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.92|-0.54|0.84
91758694|NCT00235716|183410636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.84|TWO_SIDED|95.0|-0.61|0.84||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.84|-0.61|0.84
91535554|NCT00991276|182949746|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.0001|TWO_SIDED|95.0|3.27|7.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.12|3.27|<0.0001
91535555|NCT00991276|182949747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.57||0.0396|TWO_SIDED|95.0|-10.44|-0.26||This analysis was step 6 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.26|-10.44|0.0396
91535556|NCT00991276|182949747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.55||0.0568|TWO_SIDED|95.0|-9.95|0.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.14|-9.95|0.0568
91535557|NCT00991276|182949747|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|2.52||0.8589|TWO_SIDED|95.0|-5.44|4.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.54|-5.44|0.8589
91535558|NCT00991276|182949748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001|TWO_SIDED|95.0|-20.26|-8.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.74|-20.26|<0.0001
91535559|NCT00991276|182949748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.35|STANDARD_ERROR_OF_MEAN|2.88||0.0001|TWO_SIDED|95.0|5.65|17.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.04|5.65|0.0001
91535560|NCT00991276|182949748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.84|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-31.51|-20.17||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.17|-31.51|<0.0001
91535561|NCT00991276|182949749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.53|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-20.84|-8.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.22|-20.84|<0.0001
91535562|NCT00991276|182949749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.42|STANDARD_ERROR_OF_MEAN|3.15|<|0.0001|TWO_SIDED|95.0|8.18|20.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||20.67|8.18|<0.0001
91535563|NCT00991276|182949749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-35.16|-22.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-22.74|-35.16|<0.0001
91758695|NCT00235716|183410636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.84|TWO_SIDED|95.0|-0.36|1.1||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.10|-0.36|0.84
91758696|NCT00235716|183410636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.84||95.0|-0.56|0.9||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.90|-0.56|0.84
91513178|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.8|||||TWO_SIDED|95.0|-3.1|1.6||||||Serotype 14: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.6|-3.1|
91513179|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.9||||||Serotype 18C: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.9|-3.1|
91513180|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.6|0.5||||||Serotype 19A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.5|-2.6|
91513181|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|0.2|||||TWO_SIDED|95.0|-1.5|2.0||||||Serotype 19F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||2.0|-1.5|
91513182|NCT04382326|182897997|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.6|||||TWO_SIDED|95.0|-11.4|-3.9||||||Serotype 23F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-3.9|-11.4|
91513183|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|11.2|||||TWO_SIDED|95.0|8.6|14.0||||||Serotype 8: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||14.0|8.6|
91513184|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||Serotype 10A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.3|-6.9|
91513185|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|7.1||||||95.0|4.2|10.2||||||Serotype 11A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||10.2|4.2|
91513186|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-18.1|||||TWO_SIDED|95.0|-22.1|-14.0||||||Serotype 12F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-14.0|-22.1|
91513187|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.7|||||TWO_SIDED|95.0|10.2|15.4||||||Serotype 15B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.4|10.2|
91758697|NCT00235716|183410636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.84|TWO_SIDED|95.0|-0.47|0.98||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.98|-0.47|0.84
91513188|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.8|||||TWO_SIDED|95.0|10.3|15.5||||||Serotype 22F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.5|10.3|
91513189|NCT04382326|182897997|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|1.1|||||TWO_SIDED|95.0|-2.2|4.5||||||Serotype 33F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||4.5|-2.2|
91513190|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.63|
91513191|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.61|0.73||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.73|0.61|
91513192|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.78||||||95.0|0.7|0.86||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.70|
91513193|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
91513194|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.85|0.70|
91513195|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.62|0.79||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.79|0.62|
91513196|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.76|||||TWO_SIDED|95.0|0.7|0.82||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.70|
91513197|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.8||||||95.0|0.73|0.88||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.88|0.73|
91513198|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.81|1.0||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.00|0.81|
91513199|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74||||||95.0|0.67|0.82||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
91535564|NCT00991276|182949750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.86|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.93|-1.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.80|-3.93|<0.0001
91535565|NCT00991276|182949750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.76|-3.65||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.65|-5.76|<0.0001
91535566|NCT00991276|182949750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.84|STANDARD_ERROR_OF_MEAN|0.53||0.0007|TWO_SIDED|95.0|0.79|2.89||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.89|0.79|0.0007
91535567|NCT00991276|182949751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.45|STANDARD_ERROR_OF_MEAN|1.3||0.0617|TWO_SIDED|95.0|-5.02|0.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.12|-5.02|0.0617
91535568|NCT00991276|182949751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-8.91|-3.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.80|-8.91|<0.0001
91535569|NCT00991276|182949751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.28||0.0028|TWO_SIDED|95.0|1.37|6.44||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.44|1.37|0.0028
91535570|NCT00991276|182949752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.17|-0.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.21|-1.17|0.0056
91535571|NCT00991276|182949752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.9|-0.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.95|-1.90|<0.0001
91535572|NCT00991276|182949752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.24||0.0026|TWO_SIDED|95.0|0.26|1.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.21|0.26|0.0026
91535573|NCT00991276|182949753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|95.0|-8.1|-4.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.09|-8.10|<0.0001
91513200|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.94|0.77|
91513201|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.78|0.96||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.96|0.78|
91513202|NCT04382326|182897998|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.64|||||TWO_SIDED|95.0|0.57|0.72||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.57|
91513203|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.87|||||TWO_SIDED|95.0|1.71|2.06||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.06|1.71|
91513204|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.94||||||95.0|2.64|3.26||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||3.26|2.64|
91513205|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.67|||||TWO_SIDED|95.0|1.51|1.84||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.84|1.51|
91513206|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.88||||||95.0|0.79|0.97||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.97|0.79|
91513207|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.95||||||95.0|5.39|6.55||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||6.55|5.39|
91513208|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.01||||||95.0|4.54|5.52||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.52|4.54|
91513209|NCT04382326|182897998|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.4|||||TWO_SIDED|95.0|3.99|4.85||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.85|3.99|
91513210|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-4.3|||||TWO_SIDED|95.0|-7.5|-1.4||||||Diphtheria: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-1.4|-7.5|
91758698|NCT00235716|183410636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.84|TWO_SIDED|95.0|-0.65|0.8||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.80|-0.65|0.84
91759947|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-20.21|-4.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.59|-20.21|
91513211|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.7||||||Tetanus: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.7|-1.0|
91513212|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-0.2||||||95.0|-3.5|3.1||||||Pertussis (PT): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.5|
91513213|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.6||||||95.0|-2.5|3.9||||||Pertussis (FHA): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.9|-2.5|
91513214|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-1.3||||||95.0|-4.7|2.2||||||Pertussis (PRN): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.2-Sided CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.2|-4.7|
91513215|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|2.9||||||HBsAg: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.9|-3.2|
91513216|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.4|3.2||||||Poliovirus (Type 1): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.2|-3.4|
91513217|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.8||||||95.0|-2.4|4.6||||||Poliovirus (Type 2): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||4.6|-2.4|
91513218|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|3.1||||||Poliovirus (Type 3): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.2|
91513219|NCT04382326|182897999|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Hib (≥0.15 μg/mL): 2-Sided CI were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.0|-3.0|
91513220|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.65|||||TWO_SIDED|95.0|0.59|0.72||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.59|
91513221|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.64|0.76||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.64|
91513222|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7||||||95.0|0.63|0.78||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.78|0.63|
91513223|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69||||||95.0|0.61|0.77||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.77|0.61|
91513224|NCT04382326|182898000|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72||||||95.0|0.65|0.81||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.65|
91535574|NCT00991276|182949753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.01||0.0029|TWO_SIDED|95.0|-5.07|-1.07||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.07|-5.07|0.0029
91535575|NCT00991276|182949753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.03|STANDARD_ERROR_OF_MEAN|1.01||0.0032|TWO_SIDED|95.0|-5.02|-1.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.04|-5.02|0.0032
91535576|NCT00991276|182949755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|10.69|STANDARD_ERROR_OF_MEAN|7.71||0.1677|TWO_SIDED|95.0|-4.56|25.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||25.95|-4.56|0.1677
91535577|NCT00991276|182949755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.77|STANDARD_ERROR_OF_MEAN|7.63|<|0.0001|TWO_SIDED|95.0|-50.88|-20.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.66|-50.88|<0.0001
91535578|NCT00991276|182949755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|46.47|STANDARD_ERROR_OF_MEAN|7.59|<|0.0001|TWO_SIDED|95.0|31.45|61.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||61.48|31.45|<0.0001
91535579|NCT00991276|182949756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|4.72||0.104|TWO_SIDED|95.0|-17.07|1.61||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.61|-17.07|0.1040
91535580|NCT00991276|182949756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|4.68||0.9325|TWO_SIDED|95.0|-9.67|8.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.87|-9.67|0.9325
91535581|NCT00991276|182949756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|4.65||0.1175|TWO_SIDED|95.0|-16.54|1.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.87|-16.54|0.1175
91535582|NCT00991276|182949757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.98|STANDARD_ERROR_OF_MEAN|4.45|<|0.0001|TWO_SIDED|95.0|-32.78|-15.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-15.18|-32.78|<0.0001
91758699|NCT00235716|183410637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.28|-0.33||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.33|-3.28|0.10
91758700|NCT00235716|183410637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.25|TWO_SIDED|95.0|-2.85|0.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.07|-2.85|0.25
91535583|NCT00991276|182949757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.74|STANDARD_ERROR_OF_MEAN|4.41|<|0.0001|TWO_SIDED|95.0|-33.46|-16.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-16.02|-33.46|<0.0001
91535584|NCT00991276|182949757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|4.38||0.8622|TWO_SIDED|95.0|-7.9|9.43||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.43|-7.90|0.8622
91535585|NCT00991276|182949758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.87||0.08|TWO_SIDED|95.0|-7.0|0.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.40|-7.00|0.0800
91535586|NCT00991276|182949758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|1.86||0.2209|TWO_SIDED|95.0|-5.95|1.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.39|-5.95|0.2209
91535587|NCT00991276|182949758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|1.84||0.5815|TWO_SIDED|95.0|-4.66|2.63||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.63|-4.66|0.5815
91535588|NCT00991276|182949759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.72|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|22.02|43.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||43.42|22.02|<0.0001
91535589|NCT00991276|182949759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.86|STANDARD_ERROR_OF_MEAN|5.37|<|0.0001|TWO_SIDED|95.0|15.22|36.49||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||36.49|15.22|<0.0001
91535590|NCT00991276|182949759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|5.33||0.2005|TWO_SIDED|95.0|-3.69|17.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.42|-3.69|0.2005
91535591|NCT00991276|182949760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.57|9.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.02|4.57|<0.0001
91759948|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.48|||||TWO_SIDED|95.0|-24.25|-8.71||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.71|-24.25|
91759949|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.19|||||TWO_SIDED|95.0|-19.94|-4.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-19.94|
91759950|NCT01393639|183411988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.73|||||TWO_SIDED|95.0|-15.5|0.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.04|-15.50|
91760181|NCT00286494|183412062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.28||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.28|-0.67|<0.001
91760182|NCT00286494|183412062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.41||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.41|-0.80|<0.001
91760183|NCT00286494|183412063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.36|-0.16||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.36|<0.001
91760184|NCT00286494|183412063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.41|<0.001
91760185|NCT00286494|183412064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.56|-0.27||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.56|<0.001
91760186|NCT00286494|183412064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.69|<0.001
91760187|NCT00286494|183412065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.30|-0.63|<0.001
91760188|NCT00286494|183412065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.75|-0.43||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.43|-0.75|<0.001
91760189|NCT00286494|183412066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.63|-0.26||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.63|<0.001
91760190|NCT00286494|183412066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.76|<0.001
91760191|NCT00286494|183412067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.6|-0.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.22|-0.60|<0.001
91760192|NCT00286494|183412067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.74|-0.36||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.74|<0.001
91760193|NCT00286494|183412068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.4||||0.003|TWO_SIDED|95.0|-18.9|-3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.9|-18.9|0.003
91760194|NCT00286494|183412068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-23.0|-8.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-23.0|<0.001
91760195|NCT00286494|183412069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|||<|0.001|TWO_SIDED|95.0|-26.4|-11.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.9|-26.4|<0.001
91760196|NCT00286494|183412069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|||<|0.001|TWO_SIDED|95.0|-26.6|-12.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.3|-26.6|<0.001
91760197|NCT00286494|183412070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|||<|0.001|TWO_SIDED|95.0|-27.5|-13.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.6|-27.5|<0.001
91517805|NCT01106833|182910122|SUPERIORITY|||||||0.301||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.301
91760198|NCT00286494|183412070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|||<|0.001|TWO_SIDED|95.0|-29.9|-16.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-16.0|-29.9|<0.001
91760199|NCT00286494|183412071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5|||<|0.001|TWO_SIDED|95.0|-24.4|-8.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-24.4|<0.001
91760200|NCT00286494|183412071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-28.9|-13.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.3|-28.9|<0.001
91760201|NCT00286494|183412072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.011|TWO_SIDED|95.0|-18.5|-2.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.4|-18.5|0.011
91760202|NCT00286494|183412072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|||<|0.001|TWO_SIDED|95.0|-24.3|-8.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-24.3|<0.001
91760203|NCT00286494|183412073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||0.029|TWO_SIDED|95.0|-18.9|-1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-18.9|0.029
91760204|NCT00286494|183412073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4||||0.002|TWO_SIDED|95.0|-23.3|-5.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-23.3|0.002
91760205|NCT00286494|183412074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||<|0.001|TWO_SIDED|95.0|-24.2|-6.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-24.2|<0.001
91760206|NCT00286494|183412074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-23.8|<0.001
91760207|NCT00286494|183412075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.003|TWO_SIDED|95.0|-23.1|-4.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-4.8|-23.1|0.003
91760208|NCT00286494|183412075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.003|TWO_SIDED|95.0|-23.3|-5.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-23.3|0.003
91760209|NCT00286494|183412076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.271|||<|0.001|TWO_SIDED|95.0|0.147|0.499||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.499|0.147|<0.001
91760210|NCT00286494|183412076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.235|||<|0.001|TWO_SIDED|95.0|0.126|0.438||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.438|0.126|<0.001
91760211|NCT00286494|183412077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.628||||0.266|TWO_SIDED|95.0|0.277|1.425||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.425|0.277|0.266
91517806|NCT01106833|182910122|SUPERIORITY|||||||0.75||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.750
91760212|NCT00286494|183412077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.658||||0.315|TWO_SIDED|95.0|0.292|1.487|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.487|0.292|0.315
91760213|NCT00286494|183412078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4||||0.003|TWO_SIDED|95.0|-10.6|-2.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.1|-10.6|0.003
91760214|NCT00286494|183412078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.023|TWO_SIDED|95.0|-9.1|-0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.7|-9.1|0.023
91760215|NCT00286494|183412079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.043|TWO_SIDED|95.0|-8.3|-0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-8.3|0.043
91760216|NCT00286494|183412079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.489|TWO_SIDED|95.0|-5.5|2.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.6|-5.5|0.489
91760217|NCT00286494|183412080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.068|TWO_SIDED|95.0|-8.8|0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.3|-8.8|0.068
91760218|NCT00286494|183412080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.056|TWO_SIDED|95.0|-8.9|0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.1|-8.9|0.056
91760219|NCT00286494|183412081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-4.9|4.2||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.2|-4.9|0.884
91760220|NCT00286494|183412081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-4.5|4.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-4.5|0.993
91760221|NCT00286494|183412082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.009|TWO_SIDED|95.0|-9.4|-1.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.3|-9.4|0.009
91760222|NCT00286494|183412082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.143|TWO_SIDED|95.0|-7.0|1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.0|-7.0|0.143
91760223|NCT00286494|183412083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.08|TWO_SIDED|95.0|-8.6|0.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.5|-8.6|0.080
91760224|NCT00286494|183412083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.782|TWO_SIDED|95.0|-5.2|3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.9|-5.2|0.782
91760225|NCT00286494|183412084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.249|TWO_SIDED|95.0|-2.68|0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.70|-2.68|0.249
91517807|NCT01106833|182910122|SUPERIORITY|||||||0.444||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.444
91760226|NCT00286494|183412084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.303|TWO_SIDED|95.0|-2.56|0.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.80|-2.56|0.303
91760227|NCT00286494|183412085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.478|TWO_SIDED|95.0|-2.46|1.15||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.15|-2.46|0.478
91760228|NCT00286494|183412085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.674|TWO_SIDED|95.0|-1.41|2.17||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.17|-1.41|0.674
91760229|NCT00286494|183412086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.743|TWO_SIDED|95.0|-2.18|3.06||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.06|-2.18|0.743
91760230|NCT00286494|183412086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.662|TWO_SIDED|95.0|-3.18|2.02||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.02|-3.18|0.662
91760231|NCT00286494|183412087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.39|TWO_SIDED|95.0|-0.96|2.45||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.45|-0.96|0.390
91760232|NCT00286494|183412087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.423|TWO_SIDED|95.0|-1.0|2.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.38|-1.00|0.423
91760233|NCT00286494|183412088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.807|TWO_SIDED|95.0|-1.87|1.46||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|-1.87|0.807
91760234|NCT00286494|183412088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.867|TWO_SIDED|95.0|-1.79|1.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.51|-1.79|0.867
91760235|NCT00286494|183412089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.483|TWO_SIDED|95.0|-1.1|2.33||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.33|-1.10|0.483
91760236|NCT00286494|183412089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.352|TWO_SIDED|95.0|-0.89|2.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.51|-0.89|0.352
91760237|NCT00286494|183412090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.001|TWO_SIDED|95.0|-0.092|-0.022||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.022|-0.092|0.001
91760238|NCT00286494|183412090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.001|TWO_SIDED|95.0|-0.093|-0.024||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.093|0.001
91760239|NCT00286494|183412091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.006|TWO_SIDED|95.0|-0.084|-0.014||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.014|-0.084|0.006
91760240|NCT00286494|183412091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.004|TWO_SIDED|95.0|-0.086|-0.016||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.016|-0.086|0.004
91760241|NCT00286494|183412092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.05|TWO_SIDED|95.0|-0.092|0.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.000|-0.092|0.050
91760242|NCT00286494|183412092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.014|TWO_SIDED|95.0|-0.102|-0.012||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.102|0.014
91760243|NCT00286494|183412093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027||||0.144|TWO_SIDED|95.0|-0.064|0.009||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.064|0.144
91760244|NCT00286494|183412093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.105|TWO_SIDED|95.0|-0.067|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.067|0.105
91760245|NCT00286494|183412094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.004|TWO_SIDED|95.0|-0.1|-0.019||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.100|0.004
91760246|NCT00286494|183412094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.012|TWO_SIDED|95.0|-0.092|-0.011||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.011|-0.092|0.012
91517808|NCT01106833|182910123|SUPERIORITY|||||||0.238||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.238
91760247|NCT00286494|183412095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.028|TWO_SIDED|95.0|-0.095|-0.005||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.005|-0.095|0.028
91760248|NCT00286494|183412095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.093|TWO_SIDED|95.0|-0.082|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.082|0.093
91760249|NCT00286494|183412096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.928|TWO_SIDED|95.0|-0.28|0.255||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.255|-0.280|0.928
91760250|NCT00286494|183412096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056||||0.683|TWO_SIDED|95.0|-0.212|0.324||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.324|-0.212|0.683
91760251|NCT00286494|183412097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.967|TWO_SIDED|95.0|-0.277|0.265||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.265|-0.277|0.967
91760252|NCT00286494|183412097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135||||0.327|TWO_SIDED|95.0|-0.135|0.405||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.405|-0.135|0.327
91760253|NCT00286494|183412098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068||||0.649|TWO_SIDED|95.0|-0.363|0.226||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.226|-0.363|0.649
91760254|NCT00286494|183412098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.735|TWO_SIDED|95.0|-0.344|0.243||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.243|-0.344|0.735
91760255|NCT00286494|183412099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.114|TWO_SIDED|95.0|-0.053|0.492||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.492|-0.053|0.114
91760256|NCT00286494|183412099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.086|TWO_SIDED|95.0|-0.033|0.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.510|-0.033|0.086
91760257|NCT00286494|183412100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.835|TWO_SIDED|95.0|-0.221|0.273||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.273|-0.221|0.835
91760258|NCT00286494|183412100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131||||0.296|TWO_SIDED|95.0|-0.115|0.378||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.378|-0.115|0.296
91760259|NCT00286494|183412101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123||||0.349|TWO_SIDED|95.0|-0.134|0.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.134|0.349
91760260|NCT00286494|183412101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.089|TWO_SIDED|95.0|-0.034|0.479||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.479|-0.034|0.089
91760261|NCT00286494|183412102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.815||||0.003|TWO_SIDED|95.0|1.736|13.358|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||13.358|1.736|0.003
91760262|NCT00286494|183412102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533|||<|0.001|TWO_SIDED|95.0|2.017|15.176|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||15.176|2.017|<0.001
91760263|NCT00286494|183412103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.029|TWO_SIDED|95.0|1.067|3.393|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.393|1.067|0.029
91760264|NCT00286494|183412103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.301||||0.005|TWO_SIDED|95.0|1.291|4.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regiment \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.100|1.291|0.005
91760265|NCT00286494|183412104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.783|||<|0.001|TWO_SIDED|95.0|1.547|5.005|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.005|1.547|<0.001
91760266|NCT00286494|183412104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.917|||<|0.001|TWO_SIDED|95.0|2.147|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.147|<0.001
91760267|NCT00286494|183412105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.134|||<|0.001|TWO_SIDED|95.0|2.392|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.392|<0.001
91760268|NCT00286494|183412105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.247|||<|0.001|TWO_SIDED|95.0|3.027|9.094|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.094|3.027|<0.001
91760269|NCT00286494|183412106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|1.789|7.532|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.532|1.789|<0.001
91760270|NCT00286494|183412106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.693|||<|0.001|TWO_SIDED|95.0|2.303|9.56|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.560|2.303|<0.001
91760271|NCT00286494|183412107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8||||0.015|TWO_SIDED|95.0|1.3|11.107|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.107|1.300|0.015
91760272|NCT00286494|183412107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.196||||0.002|TWO_SIDED|95.0|1.806|14.95|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||14.950|1.806|0.002
91760273|NCT00286494|183412108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.959||||0.364|TWO_SIDED|95.0|0.459|8.362|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.362|0.459|0.364
91760274|NCT00286494|183412108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.849||||0.146|TWO_SIDED|95.0|0.696|11.672|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.672|0.696|0.146
91760275|NCT00286494|183412109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.718|TWO_SIDED|95.0|-0.45|0.65||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.65|-0.45|0.718
91760276|NCT00286494|183412109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.906|TWO_SIDED|95.0|-0.52|0.58||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.58|-0.52|0.906
91760277|NCT00286494|183412110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.672|TWO_SIDED|95.0|-0.5|0.78||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.78|-0.50|0.672
91760278|NCT00286494|183412110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.922|TWO_SIDED|95.0|-0.61|0.67||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.67|-0.61|0.922
91760279|NCT00286494|183412111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.607|TWO_SIDED|95.0|-0.56|0.96||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.96|-0.56|0.607
91760280|NCT00286494|183412111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.985|TWO_SIDED|95.0|-0.77|0.76||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.76|-0.77|0.985
91760281|NCT00286494|183412112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.294|TWO_SIDED|95.0|-0.37|1.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.22|-0.37|0.294
91760282|NCT00286494|183412112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9|TWO_SIDED|95.0|-0.74|0.84||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.84|-0.74|0.900
91760283|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-1.73|||<|0.0001|TWO_SIDED|95.0|-3.17|-0.29|||ANCOVA|||||-0.29|-3.17|<0.0001
91760284|NCT03100058|183412257|OTHER|Dose finding study|Median Difference (Net)|-1.93|||<|0.0001|TWO_SIDED|95.0|-3.36|-0.5|||ANCOVA|||||-0.50|-3.36|<0.0001
91760285|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.86|-1.75|||ANCOVA|||||-1.75|-4.86|<0.0001
91760286|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-4.42|||<|0.0001|TWO_SIDED|95.0|-5.39|-3.44|||ANCOVA|||||-3.44|-5.39|<0.0001
91760287|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-2.53|-0.25|||ANCOVA|||||-0.25|-2.53|<0.0001
91760288|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-2.74|||<|0.0001|TWO_SIDED|95.0|-4.11|-1.36|||ANCOVA|||||-1.36|-4.11|<0.0001
91760289|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.54|-2.68|||ANCOVA|||||-2.68|-5.54|<0.0001
91760290|NCT03100058|183412257|OTHER|Dose finding study|Mean Difference (Net)|-4.48|||<|0.0001|TWO_SIDED|95.0|-5.54|-3.43|||ANCOVA|||||-3.43|-5.54|<0.0001
91517809|NCT01106833|182910123|SUPERIORITY|||||||0.546||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.546
91760291|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|2.38||||0.099|TWO_SIDED|95.0|0.85|6.67|||ANCOVA|||\>=5%||6.67|0.85|0.099
91760292|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio, log|1.18||||0.779|TWO_SIDED|95.0|0.36|3.84|||ANCOVA|||\>=5%||3.84|0.36|0.779
91760293|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|3.69||||0.011|TWO_SIDED|95.0|1.35|10.11|||ANCOVA|||\>=5%||10.11|1.35|0.011
91760294|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|5.57|||<|0.001|TWO_SIDED|95.0|2.41|12.88|||ANCOVA|||\>=5%||12.88|2.41|<.001
91760295|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|1.15||||0.812|TWO_SIDED|95.0|0.36|3.74|||ANCOVA|||\>=5%||3.74|0.36|0.812
91760296|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|1.94||||0.229|TWO_SIDED|95.0|0.66|5.69|||ANCOVA|||\>=5%||5.69|0.66|0.229
91760297|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|4.29||||0.004|TWO_SIDED|95.0|1.61|11.46|||ANCOVA|||\>=5%||11.46|1.61|0.004
91760298|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|6.37|||<|0.001|TWO_SIDED|95.0|2.72|14.93|||ANCOVA|||\>=5%||14.93|2.72|<.001
91760299|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|1.09||||0.943|TWO_SIDED|95.0|0.1|12.41|||ANCOVA|||\>=10%||12.41|0.10|0.943
91760300|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|2.11||||0.465|TWO_SIDED|95.0|0.28|15.77|||ANCOVA|||\>=10%||15.77|0.28|0.465
91760301|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|1.6||||0.696|TWO_SIDED|95.0|0.15|17.15|||ANCOVA|||\>=10%||17.15|0.15|0.696
91760302|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|2.14||||0.389|TWO_SIDED|95.0|0.38|12.1|||ANCOVA|||\>=10%||12.10|0.38|0.389
91760303|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|1.04||||0.976|TWO_SIDED|95.0|0.09|11.87|||ANCOVA|||\>=10%||11.87|0.09|0.976
91760304|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|1.02||||0.986|TWO_SIDED|95.0|0.09|11.7|||ANCOVA|||\>=10%||11.70|0.09|0.986
91760305|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|3.51||||0.181|TWO_SIDED|95.0|0.56|22.18|||ANCOVA|||\>=10%||22.18|0.56|0.181
91760306|NCT03100058|183412258|OTHER|Dose finding study|Odds Ratio (OR)|3.97||||0.1|TWO_SIDED|95.0|0.77|20.54|||ANCOVA|||\>=10%||20.54|0.77|0.100
91760307|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|6.29||||0.048|TWO_SIDED|95.0|1.02|38.76|||ANCOVA|||\>=5% (Dysglycemic)||38.76|1.02|0.048
91760308|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio, log|3.94||||0.171|TWO_SIDED|95.0|0.55|28.03|||ANCOVA|||\>=5% (Dsyglycemic)||28.03|0.55|0.171
91760309|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|7.17||||0.041|TWO_SIDED|95.0|1.09|47.27|||ANCOVA|||\>=5% (Dysglycemic)||47.27|1.09|0.041
91760310|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|11.89||||0.003|TWO_SIDED|95.0|2.32|60.93|||ANCOVA|||\>=5% (Dysglycemic)||60.93|2.32|0.003
91760311|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|0.96||||0.976|TWO_SIDED|95.0|0.08|11.72|||ANCOVA|||\>=5% (Dysglycemic)||11.72|0.08|0.976
91760312|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|8.78||||0.022|TWO_SIDED|95.0|1.37|56.44|||ANCOVA|||\>=5% (Dysglycemic)||56.44|1.37|0.022
91760313|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|7.5||||0.032|TWO_SIDED|95.0|1.2|46.99|||ANCOVA|||\>=5% (Dysglycemic)||46.99|1.20|0.032
91760314|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|11.28||||0.005|TWO_SIDED|95.0|2.11|60.46|||ANCOVA|||\>=5% (Dysglycemic)||60.46|2.11|0.005
91760315|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|3.21||||0.227|TWO_SIDED|95.0|0.48|21.28|||ANCOVA|||\>=5% (Normoglycemic)||21.28|0.48|0.227
91760316|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|0.69||||0.763|TWO_SIDED|95.0|0.06|7.85|||ANCOVA|||\>=5% (Normoglycemic)||7.85|0.06|0.763
91760317|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|4.68||||0.095|TWO_SIDED|95.0|0.76|28.7|||ANCOVA|||\>=5% (Normoglycemic)||28.70|0.76|0.095
91760318|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|5.33||||0.033|TWO_SIDED|95.0|1.14|24.83|||ANCOVA|||\>=5% (Normoglycemic)||24.83|1.14|0.033
91760319|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|0.72||||0.788|TWO_SIDED|95.0|0.06|8.1|||ANCOVA|||\>=5% (Normoglycemic)||8.10|0.06|0.788
91760320|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|0.68||||0.751|TWO_SIDED|95.0|0.06|7.62|||ANCOVA|||\>=5% (Normoglycemic)||7.62|0.06|0.751
91760321|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|8.05||||0.027|TWO_SIDED|95.0|1.27|51.09|||ANCOVA|||\>=5% (Normoglycemic)||51.09|1.27|0.027
91760322|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|6.64||||0.023|TWO_SIDED|95.0|1.3|34.0|||ANCOVA|||\>=5% (Normoglycemic)||34.00|1.30|0.023
91760323|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|0.48||||0.528|TWO_SIDED|95.0|0.05|4.78|||ANCOVA|||\>=5% (T2DM)||4.78|0.05|0.528
91760324|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|1.05||||0.958|TWO_SIDED|95.0|0.17|6.68|||ANCOVA|||\>=5% (T2DM)||6.68|0.17|0.958
91760325|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|1.7||||0.546|TWO_SIDED|95.0|0.3|9.49|||ANCOVA|||\>=5% (T2DM)||9.49|0.30|0.546
91760326|NCT03100058|183412259|OTHER|Dose finding test|Odds Ratio (OR)|3.09||||0.098|TWO_SIDED|95.0|0.81|11.75|||ANCOVA|||\>=5% (T2DM)||11.75|0.81|0.098
91760327|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|1.64||||0.563|TWO_SIDED|95.0|0.31|8.7|||ANCOVA|||\>=5% (T2DM)||8.70|0.31|0.563
91760328|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|0.55||||0.61|TWO_SIDED|95.0|0.06|5.38|||ANCOVA|||\>=5% (T2DM)||5.38|0.06|0.610
91760329|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|1.71||||0.528|TWO_SIDED|95.0|0.32|9.16|||ANCOVA|||\>=5% (T2DM)||9.16|0.32|0.528
91760330|NCT03100058|183412259|OTHER|Dose finding study|Odds Ratio (OR)|4.55||||0.023|TWO_SIDED|95.0|1.23|16.9|||ANCOVA|||\>=5% (T2DM)||16.90|1.23|0.023
91760331|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-0.8||||0.47|TWO_SIDED|95.0|-2.96|1.37|||ANCOVA|||||1.37|-2.96|0.470
91760332|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-1.4||||0.199|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|0.199
91760333|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-1.4|||<|0.001|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|<0.001
91760334|NCT03100058|183412260|OTHER|Dose finding study|Mean Difference (Net)|-1.4||||0.206|TWO_SIDED|95.0|-3.56|0.77|||ANCOVA|||||0.77|-3.56|0.206
91760335|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-3.0||||0.006|TWO_SIDED|95.0|-5.18|-0.88|||ANCOVA|||||-0.88|-5.18|0.006
91760336|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-3.5||||0.002|TWO_SIDED|95.0|-5.7|-1.3|||ANCOVA|||||-1.30|-5.70|0.002
91760337|NCT03100058|183412260|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-5.1|-1.51|||ANCOVA|||||-1.51|-5.10|<0.001
91760338|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-0.9||||0.391|TWO_SIDED|95.0|-2.82|1.1|||ANCOVA|||||1.10|-2.82|0.391
91760339|NCT03100058|183412260|OTHER|Dose finding study|Median Difference (Net)|-2.5||||0.259|TWO_SIDED|95.0|-3.1|0.84|||ANCOVA|||||0.84|-3.10|0.259
91760340|NCT03100058|183412260|OTHER|Dose finding study|Mean Difference (Net)|-2.5||||0.048|TWO_SIDED|95.0|-4.91|-0.02|||ANCOVA|||||-0.02|-4.91|0.048
91760341|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|1.0||||0.225|TWO_SIDED|95.0|-0.62|2.61|||ANCOVA|||||2.61|-0.62|0.225
91760342|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|-1.0||||0.247|TWO_SIDED|95.0|-2.62|0.68|||ANCOVA|||||0.68|-2.62|0.247
91760343|NCT03100058|183412261|OTHER|Dose finding study|Median Difference (Net)|-2.0||||0.019|TWO_SIDED|95.0|-3.75|-0.34|||ANCOVA|||||-0.34|-3.75|0.019
91760344|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.015|TWO_SIDED|95.0|-2.96|-0.33|||ANCOVA|||||-0.33|-2.96|0.015
91760345|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|-1.3||||0.106|TWO_SIDED|95.0|-2.97|0.29|||ANCOVA|||||0.29|-2.97|0.106
91760346|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.02|TWO_SIDED|95.0|-3.54|-0.31|||ANCOVA|||||-0.31|-3.54|0.020
91760347|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.035|TWO_SIDED|95.0|-3.44|-0.12|||ANCOVA|||||-0.12|-3.44|0.035
91760348|NCT03100058|183412261|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.004|TWO_SIDED|95.0|-3.22|-0.61|||ANCOVA|||||-0.61|-3.22|0.004
91760349|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.082|TWO_SIDED|95.0|-0.05|0.79|||ANCOVA|||||0.79|-0.05|0.082
91760350|NCT03100058|183412262|OTHER|Dose finding study|Median Difference (Net)|-0.2||||0.319|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|0.319
91760351|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.008|TWO_SIDED|95.0|-1.05|-0.16|||ANCOVA|||||-0.16|-1.05|0.008
91760352|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.015|TWO_SIDED|95.0|-0.76|-0.08|||ANCOVA|||||-0.08|-0.76|0.015
91760353|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|-0.1||||0.707|TWO_SIDED|95.0|-0.5|0.34|||ANCOVA|||||0.34|-0.50|0.707
91760354|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||||0.19|-0.65|0.280
91760355|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.086|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|||||0.05|-0.80|0.086
91760356|NCT03100058|183412262|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.03|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||||-0.04|-0.72|0.030
91760357|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.156|TWO_SIDED|95.0|-6.64|1.07|||ANCOVA|||SBP||1.07|-6.64|0.156
91760358|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-3.1||||0.127|TWO_SIDED|95.0|-7.11|0.89|||ANCOVA|||SBP||0.89|-7.11|0.127
91760359|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-6.5||||0.002|TWO_SIDED|95.0|-10.52|-2.42|||ANCOVA|||SBP||-2.42|-10.52|0.002
91760360|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.089|TWO_SIDED|95.0|-5.86|0.42|||ANCOVA|||SBP||0.42|-5.86|0.089
91760361|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.245|TWO_SIDED|95.0|-6.12|1.57|||ANCOVA|||SBP||1.57|-6.12|0.245
91760362|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-0.8||||0.678|TWO_SIDED|95.0|-4.65|3.02|||ANCOVA|||SBP||3.02|-4.65|0.678
91760363|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-4.1||||0.04|TWO_SIDED|95.0|-8.07|-0.19|||ANCOVA|||SBP||-0.19|-8.07|0.040
91760364|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-3.4||||0.038|TWO_SIDED|95.0|-6.61|-0.19|||ANCOVA|||SBP||-0.19|-6.61|0.038
91760365|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-0.7||||0.601|TWO_SIDED|95.0|-3.38|1.96|||ANCOVA|||DBP||1.96|-3.38|0.601
91760366|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.76|TWO_SIDED|95.0|-3.2|2.34|||ANCOVA|||DBP||2.34|-3.20|0.760
91760367|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.051|TWO_SIDED|95.0|-5.6|0.01|||ANCOVA|||DBP||0.01|-5.60|0.051
91760368|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.105|TWO_SIDED|95.0|-3.98|0.38|||ANCOVA|||DBP||0.38|-3.98|0.105
91760369|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|0.3||||0.82|TWO_SIDED|95.0|-2.36|2.98|||ANCOVA|||DBP||2.98|-2.36|0.820
91760370|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.157|TWO_SIDED|95.0|-4.58|0.74|||ANCOVA|||DBP||0.74|-4.58|0.157
91760371|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.859|TWO_SIDED|95.0|-2.99|2.49|||ANCOVA|||DBP||2.49|-2.99|0.859
91760372|NCT03100058|183412263|OTHER|Dose finding study|Mean Difference (Net)|-2.2||||0.054|TWO_SIDED|95.0|-4.41|0.04|||ANCOVA|||DBP||0.04|-4.41|0.054
91760373|NCT03100058|183412265|OTHER|Dose finding study|Median Difference (Net)|-0.6||||0.355|TWO_SIDED|95.0|-1.84|0.66|||ANCOVA|||||0.66|-1.84|0.355
91760374|NCT03100058|183412265|OTHER|Dose finding study|Mean Difference (Net)|-0.6||||0.373|TWO_SIDED|95.0|-1.83|0.69|||ANCOVA|||||0.69|-1.83|0.373
91760375|NCT03100058|183412265|OTHER|Dose finding study|Mean Difference (Net)|-2.8|||<|0.001|TWO_SIDED|95.0|-4.36|-1.24|||ANCOVA|||||-1.24|-4.36|<0.001
91760376|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.632|TWO_SIDED|95.0|0.81|1.42|||ANCOVA|||||1.42|0.81|0.632
91760377|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.15||||0.352|TWO_SIDED|95.0|0.86|1.55|||ANCOVA|||||1.55|0.86|0.352
91760378|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.41||||0.027|TWO_SIDED|95.0|1.04|1.92|||ANCOVA|||||1.92|1.04|0.027
91760379|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.587|TWO_SIDED|95.0|0.85|1.35|||ANCOVA|||||1.35|0.85|0.587
91760380|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.1||||0.508|TWO_SIDED|95.0|0.82|1.47|||ANCOVA|||||1.47|0.82|0.508
91760381|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.01||||0.945|TWO_SIDED|95.0|0.76|1.34|||ANCOVA|||||1.34|0.76|0.945
91760382|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.08||||0.602|TWO_SIDED|95.0|0.81|1.45|||ANCOVA|||||1.45|0.81|0.602
91760383|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|1.06||||0.612|TWO_SIDED|95.0|0.84|1.35|||ANCOVA|||||1.35|0.84|0.612
91760384|NCT03100058|183412271|OTHER|Dose finding study|Median Difference (Net)|0.89||||0.382|TWO_SIDED|95.0|0.68|1.16|||ANCOVA|||||1.16|0.68|0.382
91760385|NCT03100058|183412271|OTHER|Dose finding study|Median Difference (Net)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.14|||ANCOVA|||||1.14|0.67|0.310
91760386|NCT03100058|183412271|OTHER|Dose finding study|Mean Difference (Net)|0.9||||0.525|TWO_SIDED|95.0|0.65|1.25|||ANCOVA|||||1.25|0.65|0.525
91760387|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-7.9||||0.254|TWO_SIDED|95.0|-21.37|5.65|||ANCOVA|||Triglycerides (TG)||5.65|-21.37|0.254
91760388|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.716|TWO_SIDED|95.0|-17.44|11.99|||ANCOVA|||Triglycerides (TG)||11.99|-17.44|0.716
91760389|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-15.6||||0.038|TWO_SIDED|95.0|-30.3|-0.86|||ANCOVA|||Triglycerides (TG)||-0.86|-30.30|0.038
91760390|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-7.0||||0.213|TWO_SIDED|95.0|-18.15|4.06|||ANCOVA|||Triglycerides (TG)||4.06|-18.15|0.213
91760391|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-1.7||||0.806|TWO_SIDED|95.0|-15.38|11.96|||ANCOVA|||Triglycerides (TG)||11.96|-15.38|0.806
91760392|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.739|TWO_SIDED|95.0|-15.8|11.21|||ANCOVA|||Triglycerides (TG)||11.21|-15.80|0.739
91760393|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|1.4||||0.837|TWO_SIDED|95.0|-12.36|15.26|||ANCOVA|||Triglycerides (TG)||15.26|-12.36|0.837
91760394|NCT03100058|183412272|OTHER||Mean Difference (Net)|-11.4||||0.049|TWO_SIDED|95.0|-22.71|-0.07|||ANCOVA|||Triglycerides (TG)||-0.07|-22.71|0.049
91760395|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|1.3||||0.764|TWO_SIDED|95.0|-7.22|9.82|||ANCOVA|||Total Cholesterol (TC)||9.82|-7.22|0.764
91760396|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|2.6||||0.571|TWO_SIDED|95.0|-6.43|11.63|||ANCOVA|||Total Cholesterol (TC)||11.63|-6.43|0.571
91760397|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|0.1||||0.987|TWO_SIDED|95.0|-9.3|9.46|||ANCOVA|||Total Cholesterol (TC)||9.46|-9.30|0.987
91760398|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|9.9||||0.006|TWO_SIDED|95.0|2.85|16.87|||ANCOVA|||Total Cholesterol (TC)||16.87|2.85|0.006
91760399|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-3.3||||0.463|TWO_SIDED|95.0|-12.03|5.48|||ANCOVA|||Total Cholesterol (TC)||5.48|-12.03|0.463
91760400|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.925|TWO_SIDED|95.0|-8.18|9.01|||ANOVA|||Total Cholesterol (TC)||9.01|-8.18|0.925
91760401|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.711|TWO_SIDED|95.0|-7.19|10.53|||ANCOVA|||Total Cholesterol (TC)||10.53|-7.19|0.711
91760402|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.265|TWO_SIDED|95.0|-3.1|11.26|||ANCOVA|||Total Cholesterol (TC)||11.26|-3.10|0.265
91760403|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|0.0||||0.995|TWO_SIDED|95.0|-7.31|7.36|||ANCOVA|||HDL Cholesterol||7.36|-7.31|0.995
91760404|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.288|TWO_SIDED|95.0|-3.52|11.81|||ANCOVA|||HDL Cholesterol||11.81|-3.52|0.288
91760405|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|4.5||||0.269|TWO_SIDED|95.0|-3.5|12.5|||ANCOVA|||HDL Cholesterol||12.50|-3.50|0.269
91760406|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|7.3||||0.018|TWO_SIDED|95.0|1.23|13.27|||ANCOVA|||HDL Cholesterol||13.27|1.23|0.018
91760407|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|2.2||||0.565|TWO_SIDED|95.0|-5.32|9.73|||ANCOVA|||HDL Cholesterol||9.73|-5.32|0.565
91760408|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.649|TWO_SIDED|95.0|-5.67|9.09|||ANCOVA|||HDL Cholesterol||9.09|-5.67|0.649
91760409|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|0.7||||0.847|TWO_SIDED|95.0|-6.87|8.36|||ANCOVA|||HDL Cholesterol||8.36|-6.87|0.847
91760410|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|7.3||||0.02|TWO_SIDED|95.0|1.14|13.43|||ANCOVA|||HDL Cholesterol||13.43|1.14|0.020
91760411|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.579|TWO_SIDED|95.0|-17.09|9.57|||ANCOVA|||LDL Cholesterol||9.57|-17.09|0.579
91760412|NCT03100058|183412272|OTHER||Mean Difference (Net)|5.0||||0.487|TWO_SIDED|95.0|-9.08|19.02|||ANCOVA|||LDL Cholesterol||19.02|-9.08|0.487
91760413|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-4.3||||0.561|TWO_SIDED|95.0|-18.96|10.3|||ANCOVA|||LDL Cholesterol||10.30|-18.96|0.561
91760414|NCT03100058|183412272|OTHER||Mean Difference (Net)|9.3||||0.097|TWO_SIDED|95.0|-1.68|20.25|||ANCOVA|||LDL Cholesterol||20.25|-1.68|0.097
91760415|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-8.4||||0.227|TWO_SIDED|95.0|-22.1|5.26|||ANCOVA|||LDL Cholesterol||5.26|-22.10|0.227
91760416|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.58|TWO_SIDED|95.0|-17.22|9.64|||ANCOVA|||LDL Cholesterol||9.64|-17.22|0.580
91760417|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-4.8||||0.494|TWO_SIDED|95.0|-18.67|9.03|||ANCOVA|||LDL Cholesterol||9.03|-18.67|0.494
91760418|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.782|TWO_SIDED|95.0|-12.81|9.65|||ANCOVA|||LDL Cholesterol||9.65|-12.81|0.782
91760419|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|1.9||||0.816|TWO_SIDED|95.0|-13.82|17.54|||ANCOVA|||Triglycerides (TG)||17.54|-13.82|0.816
91760420|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|8.02||||0.341|TWO_SIDED|95.0|-8.13|23.42|||ANCOVA|||Triglycerides (TG)||23.42|-8.13|0.341
91760421|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|9.99||||0.566|TWO_SIDED|95.0|-25.39|13.91|||ANCOVA|||Triglycerides (TG)||13.91|-25.39|0.566
91760422|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|2.98||||0.405|TWO_SIDED|95.0|-3.38|8.36|||ANCOVA|||Total Cholesterol (TC)||8.36|-3.38|0.405
91760423|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|2.0||||0.511|TWO_SIDED|95.0|-3.92|7.87|||ANCOVA|||Total Cholesterol (TC)||7.87|-3.92|0.511
91760424|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|2.5||||0.506|TWO_SIDED|95.0|-4.83|9.79|||ANCOVA|||Total Cholesterol (TC)||9.79|-4.83|0.506
91760425|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|3.3||||0.392|TWO_SIDED|95.0|-4.2|10.7|||ANCOVA|||HDL Cholesterol||10.70|-4.20|0.392
91760426|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|3.0||||0.426|TWO_SIDED|95.0|-4.45|10.53|||ANOVA|||HDL Cholesterol||10.53|-4.45|0.426
91760427|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|8.5||||0.071|TWO_SIDED|95.0|-0.72|17.8|||ANCOVA|||HDL Cholesterol||17.80|-0.72|0.071
91760428|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|2.9||||0.498|TWO_SIDED|95.0|-5.56|11.42|||ANCOVA|||LDL Cholesterol||11.42|-5.56|0.498
91760429|NCT03100058|183412272|OTHER|Dose finding study|Median Difference (Net)|2.4||||0.586|TWO_SIDED|95.0|-6.17|10.9|||ANCOVA|||LDL Cholesterol||10.90|-6.17|0.586
91760430|NCT03100058|183412272|OTHER|Dose finding study|Mean Difference (Net)|2.1||||0.696|TWO_SIDED|95.0|-8.47|12.67|||ANCOVA|||LDL Cholesterol||12.67|-8.47|0.696
91760431|NCT00465088|183412277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05|Mixed Models Analysis|||An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide \> 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%||||<0.001
91760432|NCT00479856|183412317|SUPERIORITY_OR_OTHER||percentage of participants|33.3||||||95.0|7.5|70.1||||||||70.1|7.5|
91760433|NCT05758402|183412350|OTHER||Rate difference|1.21||||0.544|TWO_SIDED|95.0|-2.71|5.13|||Chi-squared||Rate difference = detection rate of PsA in EARP group - detection rate of PsA in routine practice group|||5.13|-2.71|0.544
91760434|NCT05758402|183412351|OTHER|||||||0.256|||||||Chi-squared|||Sensitivity||||0.256
91760435|NCT05758402|183412351|OTHER||||||<|0.001|||||||Chi-squared|||Specificity||||<0.001
91760436|NCT05758402|183412351|OTHER|||||||0.336|||||||Fisher Exact|||Positive Predictive Value (PPV)||||0.336
91760437|NCT05758402|183412351|OTHER|||||||0.49|||||||Chi-squared|||Negative Predictive Value (NPV)||||0.490
91760438|NCT05758402|183412352|OTHER|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||Age characteristics||||0.101
91760439|NCT05758402|183412353|OTHER|||||||0.836|||||||Chi-squared|||Gender characteristics||||0.836
91760440|NCT05758402|183412354|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Body Mass Index (BMI) characteristics||||0.520
91760441|NCT05758402|183412355|OTHER|||||||0.216|||||||Chi-squared|||Drinking history characteristics||||0.216
91760442|NCT05758402|183412355|OTHER|||||||0.719|||||||Chi-squared|||Smoking history characteristics||||0.719
91760443|NCT05758402|183412356|OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||Duration of Psoriasis (PsO) characteristics||||0.831
91760444|NCT05758402|183412357|OTHER|||||||0.274|||||||Fisher Exact|||Family history of psoriasis (PsO) characteristics||||0.274
91760445|NCT05758402|183412357|OTHER|||||||0.272|||||||Fisher Exact|||Family history of psoriatic arthritis (PsA) characteristics||||0.272
91760446|NCT05758402|183412358|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||Psoriasis Area and Severity Index (PASI) score characteristics||||0.622
91760447|NCT05758402|183412359|OTHER||||||<|0.001|||||||Chi-squared|||Status of hard-to-treat area involvement characteristics||||<0.001
91760448|NCT05758402|183412359|OTHER||||||<|0.001|||||||Chi-squared|||Status of musculoskeletal symptoms characteristics||||<0.001
91760449|NCT05758402|183412360|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left hand characteristics||||<0.001
91760450|NCT05758402|183412360|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right hand characteristics||||0.010
91760451|NCT05758402|183412360|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left foot characteristics||||0.001
91760452|NCT05758402|183412360|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right foot characteristics||||<0.001
91760453|NCT05758402|183412360|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Total NAPSI score characteristics||||0.001
91760454|NCT05758402|183412361|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66 total joint count characteristics||||<0.001
91760455|NCT05758402|183412361|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||TJC68 total joint count characteristics||||<0.001
91760456|NCT05758402|183412361|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66/TJC68 total joint count characteristics||||<0.001
91760457|NCT05758402|183412362|OTHER|||||||0.043|||||||Fisher Exact|||Heart diseases||||0.043
91760458|NCT05758402|183412362|OTHER|||||||1|||||||Fisher Exact|||Stroke||||1.000
91760459|NCT05758402|183412362|OTHER|||||||1|||||||Fisher Exact|||Diabetes||||1.000
91760460|NCT05758402|183412362|OTHER|||||||0.019|||||||Chi-squared|||Hyperlipidemia||||0.019
91760461|NCT05758402|183412362|OTHER|||||||0.073|||||||Chi-squared|||Hypertension||||0.073
91760462|NCT05758402|183412362|OTHER|||||||0.377|||||||Fisher Exact|||Fatty liver||||0.377
91760463|NCT02332291|183412364|SUPERIORITY||Odds Ratio, log|0.8642|STANDARD_ERROR_OF_MEAN|0.475||0.0689|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|||Statistical analyses utilized a logistic regression model with remission status (defined as final MADRS \<= 7) as the dependent variable. The independent variable of interest was treatment arm assignment, and the model included age, sex, and baseline depression severity by MADRS as covariates.||||0.0689
91760464|NCT02332291|183412365|SUPERIORITY||Slope, fixed effect|-1.066|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|344 degrees of freedom||Statistical analyses utilized mixed model. MADRS score was the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest for this analysis was an interaction term between time and treatment assignment. A statistically significant interaction term would indicate that one treatment arm experienced a greater change in MADRS score over time than the other treatment arm.||||0.0001
91760465|NCT02332291|183412366|SUPERIORITY||Slope, fixed effects|-0.3117|STANDARD_ERROR_OF_MEAN|0.1566||0.0483|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|150 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest was an interaction term between time and treatment assignment.||||0.0483
91760466|NCT02332291|183412367|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effect|-1.186|STANDARD_ERROR_OF_MEAN|0.181|<|0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|128 degrees of freedom||Statistical analyses utilized mixed models, with MADRS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||<0.0001
91760467|NCT02332291|183412368|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effects|-0.2342|STANDARD_ERROR_OF_MEAN|0.0908||0.0123|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|61 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||0.0123
91760468|NCT02332291|183412369|SUPERIORITY||Slope|-0.636|STANDARD_ERROR_OF_MEAN|1.924||0.742|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear model. Final AES score at week 8 was the dependent variable. Independent variables included age, sex, baseline AES score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.742
91760469|NCT02332291|183412370|SUPERIORITY||Slope|-5.4705|STANDARD_ERROR_OF_MEAN|2.352||0.0232|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear regression model. Final RRS score at week 8 was the dependent variable. Independent variables included age, sex, baseline RRS score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.0232
91760470|NCT01424228|183412374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367|||||||Cochran-Mantel-Haenszel|||||||0.367
91760471|NCT01868334|183412397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between Baseline and Year 1 for RCCT study period||||||0.05
91760472|NCT01868334|183412397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for percentage point difference between Baseline and Year 1 for RCCT study period|Cochran-Armitage trend test|||||||0.05
91760473|NCT01868334|183412398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between pre and post intervention for Pre-post study period||||||0.05
91760474|NCT01868334|183412398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for difference between pre and post changes in vaccination rates for Pre-Post study period|Cochran-Armitage trend test|||||||0.05
91760475|NCT02478255|183412403|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
91760476|NCT00571974|183412409|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||One-sided exact binomial test to compare the observed response rate to the 20% rate envisioned under the original null hypothesis.|One-sided exact binomial test|Because all but one subject responded to treatment, the Fisher's exact test was addedd.||The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall. This design's early termination rule was ≤3/9 responses in the first stage, and its success criterion was ≥7/17 responses overall. This design had 80% power at 5% alpha to distinguish an efficacious 50% response rate from a null-hypothesis 20% response rate.||||0.0001
91760477|NCT02813889|183412410|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0054|TWO_SIDED|95.0|-0.0261|-0.0031||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0031|-0.0261|0.0054
91760478|NCT02813889|183412411|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.02||||0.0005|TWO_SIDED|95.0|-0.0331|-0.007||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0070|-0.0331|0.0005
91760479|NCT02813889|183412412|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0088|TWO_SIDED|95.0|-0.0267|-0.0026||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0026|-0.0267|0.0088
91760480|NCT02813889|183412413|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0059||||0.7624|TWO_SIDED|95.0|-0.018|0.0062||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||0.0062|-0.0180|0.7624
91760481|NCT02813889|183412414|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0129||||0.0326|TWO_SIDED|95.0|0.0007|0.0251||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0251|0.0007|0.0326
91760482|NCT02813889|183412415|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0309|||<|0.0001|TWO_SIDED|95.0|0.0138|0.048||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0480|0.0138|<0.0001
91760483|NCT02813889|183412416|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.017||||0.0025|TWO_SIDED|95.0|0.0045|0.0295||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0295|0.0045|0.0025
91760484|NCT02813889|183412417|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0066||||0.6782|TWO_SIDED|95.0|-0.0059|0.0191||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0191|-0.0059|0.6782
91760485|NCT02813889|183412418|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.064||||0.0479|TWO_SIDED|95.0|0.006|2.122||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.122|0.006|0.0479
91760486|NCT02813889|183412419|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.278||||0.9947|TWO_SIDED|95.0|-0.921|1.477||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.477|-0.921|0.9947
91760487|NCT02813889|183412420|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.835||||0.2614|TWO_SIDED|95.0|-0.274|1.945||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.945|-0.274|0.2614
91760488|NCT02813889|183412421|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.176||||0.0314|TWO_SIDED|95.0|0.066|2.286||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.286|0.066|0.0314
91760489|NCT02813889|183412422|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.074||||0.0958|TWO_SIDED|95.0|-2.255|0.1059||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1059|-2.255|0.0958
91760490|NCT02813889|183412423|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.5248||||0.966|TWO_SIDED|95.0|-1.1243|2.1739||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||2.1739|-1.1243|0.9660
91760491|NCT02813889|183412424|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.4198||||0.9462|TWO_SIDED|95.0|-1.6278|0.7882||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.7882|-1.6278|0.9462
91760492|NCT02813889|183412425|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.0705||||0.1129|TWO_SIDED|95.0|-2.2785|0.1375||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1375|-2.2785|0.1129
91760493|NCT05224453|183412443|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-5.0|||<|0.05|TWO_SIDED|95.0|-6.21|-3.78|||t-test, 2 sided|||||-3.78|-6.21|<0.05
91760494|NCT05224453|183412444|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-3.7|||<|0.05|TWO_SIDED|95.0|-6.53|-0.86|||t-test, 2 sided|||||-0.86|-6.53|<0.05
91760495|NCT05224453|183412444|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-1.7|||<|0.05|TWO_SIDED|95.0|-3.84|0.44|||t-test, 2 sided|||||0.44|-3.84|<0.05
91760496|NCT02974257|183412447|OTHER|Linear mixed-effects model with an independent variance-covariance matrix to account for the correlation of within-patient repeated measures was used and linear contrasts were used to estimate the mean difference between treatment arms at 48 hours.|Mean Difference (Final Values)|1.5||||0.9|TWO_SIDED|95.0|-3.1|6.1||Global p-value from the mixed model.|Mixed Models Analysis|If patients died before 48 hours lactate levels were imputed by carrying forward the last known value before the event with a 20% increase||||6.1|-3.1|0.9
91760497|NCT02974257|183412448|OTHER||Mean Difference (Final Values)|-0.36||||0.42|TWO_SIDED|95.0|-1.29|0.56|||Regression, Linear|||AUC-VO2 normally distributed, used a linear regression model to compare mean AUC-VO2 between treatment groups controlling for average temperature.||0.56|-1.29|0.42
91760498|NCT02974257|183412449|OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.9|0.3||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between thiamine and placebo groups at 48 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||0.3|-0.9|0.07
91760499|NCT00793325|183412459|SUPERIORITY_OR_OTHER||||||=|0.575|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<15 years and \>=15 years in the frequency of treatment related adverse events."||||=0.575
91760500|NCT00793325|183412460|SUPERIORITY_OR_OTHER||||||=|0.206|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.206
91760501|NCT00793325|183412461|SUPERIORITY_OR_OTHER||||||=|0.033|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity. The null hypothesis is that there is no association between mild, moderate and severe in the frequency of treatment related adverse events."||||=0.033
91760502|NCT00793325|183412461|SUPERIORITY_OR_OTHER||||||=|0.207|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Severity. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity."||||=0.207
91760503|NCT00793325|183412462|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Past history of any disease. The null hypothesis is that there is no difference between With past history of any disease and Without past history any disease in the frequency of treatment related adverse events."||||=0.013
91760504|NCT00793325|183412463|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Complication(s). The null hypothesis is that there is no difference between With complication(s) and Without complication(s)in the frequency of treatment related adverse events."||||=0.009
91760505|NCT00793325|183412464|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Hepatic Function Disorder. The null hypothesis is that there is no difference between with Hepatic Function Disorder and without Hepatic Function Disorder in the frequency of treatment related adverse events."||||<0.001
91760506|NCT00793325|183412465|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Renal Impairment. The null hypothesis is that there is no difference between With Renal Impairment and Without Renal Impairment in the frequency of treatment related adverse events."||||<0.001
91517810|NCT01106833|182910123|SUPERIORITY|||||||0.756||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.756
91760507|NCT00793325|183412466|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Concomitant Drug(s). The null hypothesis is that there is no difference between With Concomitant Drug(s) and Without Concomitant Drug(s) in the frequency of treatment related adverse events."||||=0.003
91760508|NCT00793325|183412467|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
91760509|NCT00793325|183412467|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
91760510|NCT00793325|183412467|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
91760511|NCT00793325|183412468|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
91760512|NCT00793325|183412468|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
91760513|NCT00793325|183412468|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
91760514|NCT02920749|183412570|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
91760515|NCT02920749|183412571|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
91760516|NCT05438576|183412577|SUPERIORITY||Odds Ratio (OR)|2.12||||0.032|TWO_SIDED|95.0|1.05|4.27|||Regression, Logistic|||||4.27|1.05|0.032
91760517|NCT05438576|183412582|SUPERIORITY||Odds Ratio (OR)|1.1||||0.621|TWO_SIDED|95.0|0.74|1.64|||Regression, Logistic|||||1.64|0.74|0.621
91517811|NCT01106833|182910123|SUPERIORITY|||||||0.554||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.554
91760518|NCT02881762|183412587|OTHER|Comparison of mean change analyzed with unpaired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).||||||0.13|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in change in HCV viral load between Maraviroc and No Maraviroc||||0.13
91760519|NCT02881762|183412588|OTHER|Comparison of difference in mean analyzed with paired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).|||||>|0.5|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in HCV viral load between baseline and 7 days of maraviroc.||||>0.5
91760520|NCT00774800|183412614|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.54||||0.0011||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0011
91760521|NCT00774800|183412614|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|3.06|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
91760522|NCT00774800|183412615|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.35||||0.0057||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0057
91760523|NCT00774800|183412615|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.66|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
91760524|NCT00774800|183412616|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-18.33|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
91760525|NCT00774800|183412616|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-62.46||||0.0018|||||||ANOVA|Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0018
91760526|NCT01843062|183412618|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||The primary endpoint was to be considered statistically significant if the 2-sided p-value was less than 0.05. P-value and confidence intervals (CIs) were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
91760527|NCT01843062|183412619|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
91760528|NCT01843062|183412620|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
91760529|NCT01843062|183412621|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
91760530|NCT03549104|183412641|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
91760531|NCT03549104|183412642|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
91760532|NCT03549104|183412643|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
91760533|NCT04124705|183412644|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-15.16|||||TWO_SIDED|95.0|-26.1|-4.23|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for the primary efficacy endpoint, sustained TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance (equivalent to a two-sided 5% level of significance).||-4.23|-26.10|
91760534|NCT04124705|183412645|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-10.52|||||TWO_SIDED|95.0|-18.65|-2.38|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for titration TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance.||-2.38|-18.65|
91760535|NCT04164732|183412646|SUPERIORITY||Median Difference (Net)|0.61||||0.5506|TWO_SIDED|80.0|-0.71|1.94|||longitudinal mixed effects (MMRM) model|||||1.94|-0.71|0.5506
91760536|NCT00395850|183412649|SUPERIORITY_OR_OTHER||Slope|-1.02|||<|0.05|||||||Repeated Measures Logistic Regression|Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression||Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data||||<0.05
91760537|NCT00395850|183412650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91760538|NCT02540993|183412658|SUPERIORITY||Hazard Ratio (HR)|0.825|||=|0.0014|TWO_SIDED|95.0|0.732|0.928||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.03282695.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.928|0.732|= 0.0014
91760539|NCT02540993|183412659|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0339|TWO_SIDED|95.0|0.747|0.989||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.989|0.747|= 0.0339
91760540|NCT02540993|183412660|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.895|||=|0.2348|TWO_SIDED|95.0|0.746|1.075||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.075|0.746|= 0.2348
91760541|NCT02540993|183412661|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.946|||=|0.1623|TWO_SIDED|95.0|0.876|1.022||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.022|0.876|= 0.1623
91760542|NCT02540993|183412662|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Ratio of least squares means|0.688|||<|0.0001|TWO_SIDED|95.0|0.662|0.715||P-value from F-test of equal means between the treatment groups.|ANCOVA|||||0.715|0.662|< 0.0001
91760543|NCT02540993|183412663|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.763|||=|0.0012|TWO_SIDED|95.0|0.648|0.9||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.900|0.648|= 0.0012
91760544|NCT02951429|183412676|SUPERIORITY||Difference of percentage of participants|3.06||||0.6527|TWO_SIDED|95.0|-11.3|17.97|||Chi-squared|||||17.97|-11.30|0.6527
91760545|NCT02951429|183412677|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.7568|TWO_SIDED|95.0|0.67|1.34|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.34|0.67|0.7568
91760546|NCT02951429|183412678|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.15|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.15|0.68|0.3760
91760547|NCT02951429|183412679|SUPERIORITY||Difference (95% CI)|2.85||||0.7046|TWO_SIDED|95.0|-12.13|17.84|||Chi-squared|||||17.84|-12.13|0.7046
91760548|NCT02951429|183412680|SUPERIORITY||Difference (95% CI)|0.94||||0.755|TWO_SIDED|95.0|0.62|1.41|||Log Rank|||||1.41|0.62|0.7550
91760549|NCT02951429|183412681|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9174|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.9174
91760550|NCT02951429|183412682|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7748|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||||1.62|0.70|0.7748
91760551|NCT02951429|183412683|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4258|TWO_SIDED|95.0|0.38|1.5|||Log Rank|||||1.50|0.38|0.4258
91760552|NCT02951429|183412685|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.3161|TWO_SIDED|95.0|0.31|1.47|||Log Rank|||||1.47|0.31|0.3161
91760553|NCT02951429|183412695|SUPERIORITY||Difference in mean change from baseline|-206.59||||0.5646|TWO_SIDED|95.0|-920.03|506.85|||Linear Mixed Effects Model|||||506.85|-920.03|0.5646
91760554|NCT02951429|183412696|SUPERIORITY||Median Difference (Final Values)|-3.33||||0.5255|TWO_SIDED|95.0|-9.98|2.36|||ANCOVA|Difference in mean change in total score: -4.22||||2.36|-9.98|0.5255
91760555|NCT02951429|183412697|SUPERIORITY||Median Difference (Final Values)|-6.0||||0.4263|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Difference in mean change in total score: -5.07||||6.00|-18.00|0.4263
91760556|NCT03997825|183412704|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
91760557|NCT03997825|183412705|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
91760558|NCT05546229|183412738|OTHER|||||||0.0049|||||||t-test, 2 sided|8 degrees of freedom||patient plasma versus isf value for methadone||||.0049
91760559|NCT05546229|183412739|OTHER|||||||0.0025|||||||t-test, 2 sided|8 degrees of freedom||||||.0025
91760560|NCT00847197|183412751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.1||0.926|TWO_SIDED|95.0|-3.9|4.3||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||4.3|-3.9|0.926
91760561|NCT00847197|183412752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|1.8||0.013|TWO_SIDED|95.0|1.0|8.1||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||8.1|1.0|0.013
91760562|NCT00847197|183412753|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|8.6||0.02|TWO_SIDED|95.0|-18.9|-1.9|||Wilcoxon's Rank Sum Test|The significance test was 2-tailed with α=0.05.||Triglycerides was analyzed by non-parametric methods with terms for treatment, gender and region. Specifically, the analysis of variance (ANOVA) model was applied to the Tukey's normal scores of the percent change from baseline. The estimate of the difference in medians between MK1903 and the placebo groups utilizing the Hodges-Lehmann estimate and a distribution-free 95% CI for the difference based on Wilcoxon's rank sum test was provided.||-1.9|-18.9|0.02
91760563|NCT03824587|183412782|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|99.0|-1.13|-0.18|||Mixed Models Analysis|||||-0.18|-1.13|0.0004
91760564|NCT03824587|183412783|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0097|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0097
91760565|NCT03824587|183412784|SUPERIORITY|||||||0.0027|||||||ANOVA|||||||0.0027
91760566|NCT03824587|183412785|SUPERIORITY|||||||0.0011|||||||ANOVA|||||||0.0011
91760567|NCT02921087|183412802|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.07
91760568|NCT02921087|183412804|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.01
91760569|NCT02921087|183412805|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.77
91760570|NCT02921087|183412806|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.69
91760571|NCT02921087|183412807|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.87
91760572|NCT01128244|183412812|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|||||Threshold for significance P\<0.05|t-test, 2 sided|Paired t-test||||||0.20
91760573|NCT01128244|183412813|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.62
91760574|NCT01128244|183412814|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||<0.001
91760575|NCT01128244|183412815|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.45
91760576|NCT01128244|183412816|SUPERIORITY_OR_OTHER||Test of treatment effect.|0.05|||<|0.05|TWO_SIDED|||||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|t-test, 2 sided|||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.||||<0.05
91760577|NCT01363908|183412833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0781
91760578|NCT01363908|183412833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.5000
91760579|NCT01363908|183412833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2609|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.2609
91760580|NCT01363908|183412833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.9219
91760581|NCT01363908|183412835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6875|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.6875
91760582|NCT01363908|183412835|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||1.0000
91760583|NCT01363908|183412835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8181|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.8181
91760584|NCT01363908|183412835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5566|TWO_SIDED|||||P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank|||Analysis of 12 to \<18 year olds at 48 weeks||||0.5566
91760585|NCT01363908|183412837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0475|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0475
91760586|NCT01363908|183412837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.||Analysis of 6 to \<12 year olds at 48 weeks||||0.4410
91760587|NCT01363908|183412837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0417|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0417
91760588|NCT01363908|183412837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0409|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0409
91760589|NCT01363908|183412838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9901|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.9901
91760590|NCT01363908|183412838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3039|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.3039
91760591|NCT01363908|183412838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0044|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0044
91760592|NCT01363908|183412838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0395|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0395
91760593|NCT05258149|183412839|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.65|||||TWO_SIDED|95.0|1.1|2.46|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.46|1.10|
91760594|NCT05258149|183412840|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.27|2.79|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.79|1.27|
91760595|NCT05258149|183412841|NON_INFERIORITY|A Non-Inferiority margin of 10% was used.|Odds Ratio (OR)|0.74|||||TWO_SIDED|98.33|0.42|1.3|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|1.30|0.42|
91760596|NCT05258149|183412842|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.58|||||TWO_SIDED|98.33|0.91|2.75|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|2.75|0.91|
91760597|NCT05258149|183412843|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|2.08|||||TWO_SIDED|98.33|1.24|3.5|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|3.50|1.24|
91760598|NCT01013194|183412850|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||Fisher Exact|||||||0.4340
91760599|NCT01013194|183412851|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0076
91760600|NCT01013194|183412852|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0437
91760601|NCT04273893|183412859|OTHER|||||||0.05||||||Changes from baseline ALC were conducted using repeated measures models with an unstructured covariance matrix and model terms for tumor location, follow-up time. Adjustments for stratification factors were made using least squares means.|t-test, 2 sided|||||||0.05
91760602|NCT02936843|183412875|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided||TTEST, two sided||||0.41
91760603|NCT01393821|183412890|SUPERIORITY|||||||0.6311|||||||Kruskal-Wallis|||||||0.6311
91760604|NCT01318408|183412896|NON_INFERIORITY_OR_EQUIVALENCE|Assessing effects on cognition over time.||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants' scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.||||.01
91760605|NCT01318408|183412897|NON_INFERIORITY_OR_EQUIVALENCE|Assessing cognitive effects over time.||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Lower scores (negative change) indicate improvements on the ADAS-cog.||||||.02
91760606|NCT02932748|183412902|SUPERIORITY||||||<|0.0001||||||A global one-way ANOVA was followed by two pairwise t-tests on the comparisons of interest, i.e., IP vs. EUC, and GP vs IP for weight change across 6 months, evaluated at p ≤ 0.025, using both intent-to-treat and completer only data.|ANOVA|||||||<.0001
91760607|NCT00475904|183412910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.547|STANDARD_ERROR_OF_MEAN|0.2709||0.0441|TWO_SIDED|95.0|0.01|1.08||a priori threshold for statistical significance was p\<0.05|ANOVA|||In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.||1.08|0.01|0.0441
91760608|NCT00475904|183412911|NON_INFERIORITY_OR_EQUIVALENCE|To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.2311||0.8409|TWO_SIDED|90.0|-0.33|0.43||To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|ANCOVA|||the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.||0.43|-0.33|0.8409
91760609|NCT00880191|183412912|SUPERIORITY_OR_OTHER|||||||0.2344|TWO_SIDED||||||Fisher Exact|||Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher's exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.||||0.2344
91760610|NCT00880191|183412913|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||Fisher Exact|||The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents.||||0.3694
91760611|NCT00066963|183412921|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|1.9|7.6|||Mantel Haenszel|2 d.f.|Counseling Only vs FV 2x/yr+Counseling|Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)||7.6|1.9|<0.001
91760612|NCT00773747|183412922|SUPERIORITY||Cox Proportional Hazard|0.774|||=|0.01|TWO_SIDED|95.0|0.636|0.941|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||0.941|0.636|= 0.0100
91760613|NCT00773747|183412924|SUPERIORITY||Cox Proportional Hazard|0.858||||0.3496|TWO_SIDED|95.0|0.622|1.184|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||1.184|0.622|0.3496
91760614|NCT03422536|183412933|EQUIVALENCE|The pre-specified significance criteria were met by exclusion of the historical control PFS of 2.0 months. As confirmation, the one-sample log rank test was computed with expected survival estimated using an exponential distribution of 2.0 months.||||||0.04||||||The a priori threshold for statistical significance is \<.05|Log Rank|||||||.04
91760615|NCT03422536|183412938|SUPERIORITY|||||||0.005|||||||Regression, Cox|||c-Met positivity was compared across groups: HPV+ vs HPV-||||.005
91760616|NCT03422536|183412938|SUPERIORITY||Cox Proportional Hazard|0.3||||0.02|TWO_SIDED|95.0|0.1|0.8|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in cMet positive vs. c-Met negative patients.||0.8|0.1|.02
91760617|NCT03422536|183412938|SUPERIORITY||Cox Proportional Hazard|0.1||||0.03|TWO_SIDED|95.0|0.03|0.8|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV- patients in the combination arm.||0.8|0.03|0.03
91760618|NCT03422536|183412938|SUPERIORITY||Cox Proportional Hazard|3.2||||0.2|TWO_SIDED|95.0|0.6|17.5|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV+ patients in the combination arm.||17.5|0.6|.20
91760619|NCT03422536|183412938|SUPERIORITY||Cox Proportional Hazard|1.4||||0.1|TWO_SIDED|95.0|0.9|2.0|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in HGF positive vs. HGF negative patients.||2.0|0.9|.10
91760620|NCT03422536|183412938|SUPERIORITY||Cox Proportional Hazard|1.4||||0.6|TWO_SIDED|95.0|0.4|4.7|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV- patients in the combination arm.||4.7|0.4|.60
91760621|NCT03422536|183412938|SUPERIORITY||Cox Proportional Hazard|3.4||||0.07|TWO_SIDED|95.0|0.9|13.1|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P \< .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV+ patients in the combination arm.||13.1|0.9|.07
91760622|NCT01973998|183412942|EQUIVALENCE|The primary outcome is time from randomization to a composite outcome of all cause re-hospitalization and all-cause mortality, whichever comes first. The primary analysis will be a log-ranked test and associated Kaplan-Meier plot, unadjusted for any covariates|Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789|<|0.1|TWO_SIDED|10.0|1.175|2.133||Because this is a pilot study the intent is to see if there is a signal that would justify a larger clinical trial. Therefore the significance level has been set to 0.1 and the power has been set at 0.7.|Log Rank|||||2.133|1.175|<0.1
91760623|NCT01973998|183412942|SUPERIORITY||Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789||0.1|TWO_SIDED|10.0|1.175|2.133|||Log Rank|||A total of 100 patients is required in a 2 treatment parallel-design study. There is a 70% probability that the study will detect a treatment difference at a 2-sided 10% significance level, if the true hazard ratio is 1.654. This is based on the assumption that the accrual period will be 36 months and the follow up period will be 6 months and the median time to event is 8 months. The total number of events will be 73.||2.133|1.175|0.1
91760624|NCT02160145|183412971|OTHER||Treatment difference|1.271|||<|0.0001|TWO_SIDED|95.0|0.859|1.684||A 2-sided alpha of 0.05 was applied to the primary analysis of the primary endpoint.|ANCOVA|Weighted Analysis of Covariance (ANCOVA) with effects of treatment and randomization stratification factors and covariate baseline.||Tolvaptan versus placebo. Treatment difference in the change of eGFR assessed the efficacy of tolvaptan treatment as compared with placebo in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period.||1.684|0.859|<0.0001
91760625|NCT02160145|183412972|OTHER||Treatment difference|1.011|||<|0.0001|TWO_SIDED|95.0|0.618|1.403||A two-sided alpha of 0.05 was applied when the primary endpoint reached a two-sided alpha of 0.05.|Mixed Models Analysis|||Difference in treatment effect was derived from a linear mixed model with effects of treatment, time, treatment ime interaction, acute haemodynamic effect, pretreatment baseline, and randomization stratification factors. An unstructured variance matrix was assumed for the random intercept and time.||1.403|0.618|<0.0001
91760626|NCT01620528|183412987|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760627|NCT01620528|183412987|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760628|NCT01620528|183412988|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760629|NCT01620528|183412988|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760630|NCT01620528|183412989|SUPERIORITY||Difference in LS Mean Change|-0.65|STANDARD_ERROR_OF_MEAN|0.155|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
91760631|NCT01620528|183412989|SUPERIORITY||Difference in LS Mean Change|-1.3|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
91760632|NCT01620528|183412990|SUPERIORITY||Difference in LS Mean Change|-0.45|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|95.0|||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
91760633|NCT01620528|183412990|SUPERIORITY||Difference in Least Squares Mean|-1.32|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
91760634|NCT01620528|183412991|SUPERIORITY||Difference in LS Mean Change|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.004
91760635|NCT01620528|183412991|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
91760636|NCT01620528|183412992|SUPERIORITY||Difference in LS Mean Change|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.91|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.910
91760637|NCT01620528|183412992|SUPERIORITY||Difference in LS Mean Change|-0.26|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
91760638|NCT01620528|183412993|SUPERIORITY||Difference in LS Mean Change|-0.07|STANDARD_ERROR_OF_MEAN|0.056||0.185|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.185
91760639|NCT01620528|183412993|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
91760640|NCT01620528|183412994|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.144|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.144
91760641|NCT01620528|183412994|SUPERIORITY||Difference in LS Mean Change|-0.2|STANDARD_ERROR_OF_MEAN|0.067||0.003|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.003
91760642|NCT01620528|183412995|SUPERIORITY||Difference in LS Mean Change|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.424|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.424
91760643|NCT01620528|183412995|SUPERIORITY||Difference in LS Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.038||0.002|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.002
91760644|NCT01620528|183412996|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760645|NCT01620528|183412996|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760646|NCT01620528|183412997|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760647|NCT01620528|183412997|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760648|NCT01620528|183412998|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760649|NCT01620528|183412998|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760650|NCT01620528|183412999|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760651|NCT01620528|183412999|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760652|NCT01620528|183413000|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760653|NCT01620528|183413000|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760654|NCT01620528|183413001|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
91760655|NCT01620528|183413001|SUPERIORITY|||||||0.023|||||||Regression, Logistic|||||||0.023
91760656|NCT01620528|183413002|SUPERIORITY|||||||0.031|||||||Regression, Logistic|||||||0.031
91760657|NCT01620528|183413002|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760658|NCT01620528|183413003|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760659|NCT01620528|183413003|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760660|NCT01620528|183413004|SUPERIORITY|||||||0.005|||||||Regression, Logistic|||||||0.005
91760661|NCT01620528|183413004|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760662|NCT01620528|183413005|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
91760663|NCT01620528|183413005|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760664|NCT01620528|183413006|SUPERIORITY|||||||0.306|||||||Regression, Logistic|||||||0.306
91760665|NCT01620528|183413006|SUPERIORITY|||||||0.239|||||||Regression, Logistic|||||||0.239
91760666|NCT01620528|183413007|SUPERIORITY|||||||0.855|||||||Regression, Logistic|||||||0.855
91760667|NCT01620528|183413007|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
91760668|NCT01620528|183413008|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.010
91760669|NCT01620528|183413008|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760670|NCT01620528|183413009|SUPERIORITY|||||||0.061|||||||Regression, Logistic|||||||0.061
91760671|NCT01620528|183413009|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760672|NCT01620528|183413010|SUPERIORITY|||||||0.126|||||||Regression, Logistic|||||||0.126
91760673|NCT01620528|183413010|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
91760674|NCT01620528|183413011|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.65|-0.34|||mixed-effects model|||||-0.34|-0.65|< 0.001
91760675|NCT01620528|183413011|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
91760676|NCT01620528|183413012|SUPERIORITY||LS Mean of Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-0.79|-0.49|||mixed-effects model|||||-0.49|-0.79|< 0.001
91760677|NCT01620528|183413012|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.51|-1.2|||mixed-effects model|||||-1.20|-1.51|< 0.001
91760678|NCT01620528|183413013|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.83|-0.53|||mixed-effects model|||||-0.53|-0.83|< 0.001
91760679|NCT01620528|183413013|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|97.5|-1.54|-1.23|||mixed-effects model|||||-1.23|-1.54|< 0.001
91760680|NCT01620528|183413014|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
91760681|NCT01620528|183413014|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.49|-1.16|||mixed-effects model|||||-1.16|-1.49|< 0.001
91517812|NCT01106833|182910124|SUPERIORITY|||||||0.685||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.685
91760682|NCT01620528|183413015|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.75|-0.43|||mixed-effects model|||||-0.43|-0.75|< 0.001
91760683|NCT01620528|183413015|SUPERIORITY||LS Mean of Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.58|-1.25|||mixed-effects model|||||-1.25|-1.58|< 0.001
91760684|NCT01620528|183413016|SUPERIORITY||LS Mean of Difference|-24.07|STANDARD_ERROR_OF_MEAN|3.288|<|0.001|TWO_SIDED|97.5|-31.45|-16.69|||mixed-effects model|||||-16.69|-31.45|< 0.001
91760685|NCT01620528|183413016|SUPERIORITY||LS Mean of Difference|-31.01|STANDARD_ERROR_OF_MEAN|3.299|<|0.001|TWO_SIDED|97.5|-38.41|-23.6|||mixed-effects model|||||-23.60|-38.41|< 0.001
91760686|NCT01620528|183413017|SUPERIORITY||LS Mean of Difference|-30.79|STANDARD_ERROR_OF_MEAN|3.107||-30.79|TWO_SIDED|97.5|-37.77|-23.82|||mixed-effects model|||||-23.82|-37.77|-30.79
91760687|NCT01620528|183413017|SUPERIORITY||LS Mean of Difference|-63.78|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|97.5|-70.85|-56.71|||mixed-effects model|||||-56.71|-70.85|< 0.001
91760688|NCT01620528|183413018|SUPERIORITY||LS Mean of Difference|-32.21|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|97.5|-39.35|-25.08|||mixed-effects model|||||-25.08|-39.35|< 0.001
91760689|NCT01620528|183413018|SUPERIORITY||LS Mean of Difference|-64.94|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|97.5|-72.19|-57.68|||mixed-effects model|||||-57.68|-72.19|< 0.001
91760690|NCT01620528|183413019|SUPERIORITY||LS Mean of Difference|-29.94|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|97.5|-37.28|-22.59|||mixed-effects model|||||-22.59|-37.28|< 0.001
91760691|NCT01620528|183413019|SUPERIORITY||LS Mean of Difference|-61.9|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|97.5|-69.44|-54.36|||mixed-effects model|||||-54.36|-69.44|< 0.001
91760692|NCT01620528|183413020|SUPERIORITY||LS Mean of Difference|-28.63|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|97.5|-35.96|-21.31|||mixed-effects model|||||-21.31|-35.96|< 0.001
91760693|NCT01620528|183413020|SUPERIORITY||LS Mean of Difference|-66.5|STANDARD_ERROR_OF_MEAN|3.321|<|0.001|TWO_SIDED|97.5|-73.95|-59.04|||mixed-effects model|||||-59.04|-73.95|< 0.001
91760694|NCT01620528|183413021|SUPERIORITY||LS Mean of Difference|-21.39|STANDARD_ERROR_OF_MEAN|3.479|<|0.001|TWO_SIDED|97.5|-29.2|-13.57|||mixed-effects model|||||-13.57|-29.20|< 0.001
91760695|NCT01620528|183413021|SUPERIORITY||LS Mean of Difference|-60.78|STANDARD_ERROR_OF_MEAN|3.557|<|0.001|TWO_SIDED|97.5|-68.77|-52.79|||mixed-effects model|||||-52.79|-68.77|< 0.001
91760696|NCT01620528|183413022|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.036||0.111|TWO_SIDED|97.5|-0.14|0.02|||mixed-effects model|||||0.02|-0.14|0.111
91760697|NCT01620528|183413022|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.036||0.008|TWO_SIDED|97.5|-0.18|-0.01|||mixed-effects model|||||-0.01|-0.18|0.008
91760698|NCT01620528|183413023|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|97.5|-0.18|0.02|||mixed-effects model|||||0.02|-0.18|0.092
91760699|NCT01620528|183413023|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.28|-0.08|||mixed-effects model|||||-0.08|-0.28|< 0.001
91760700|NCT01620528|183413024|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.017|TWO_SIDED|97.5|-0.23|-0.01|||mixed-effects model|||||-0.01|-0.23|0.017
91760701|NCT01620528|183413024|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||||-0.18|-0.41|< 0.001
91760702|NCT01620528|183413025|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.31|-0.07|||mixed-effects model|||||-0.07|-0.31|< 0.001
91760703|NCT01620528|183413025|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.51|-0.27|||mixed-effects model|||||-0.27|-0.51|< 0.001
91760704|NCT01620528|183413026|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.053||0.004|TWO_SIDED|97.5|-0.27|-0.03|||mixed-effects model|||||-0.03|-0.27|0.004
91760705|NCT01620528|183413026|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.52|-0.27|||mixed-effects model|||||-0.27|-0.52|< 0.001
91760706|NCT01620528|183413027|SUPERIORITY||LS Mean of Difference|-6.23|STANDARD_ERROR_OF_MEAN|2.748||0.024|TWO_SIDED|97.5|-12.4|-0.06|||mixed-effects model|||||-0.06|-12.40|0.024
91760707|NCT01620528|183413027|SUPERIORITY||LS Mean of Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.756||0.005|TWO_SIDED|97.5|-13.9|-1.53|||mixed-effects model|||||-1.53|-13.90|0.005
91760708|NCT01620528|183413028|SUPERIORITY||LS Mean of Difference|-5.69|STANDARD_ERROR_OF_MEAN|3.226||0.078|TWO_SIDED|97.5|-12.93|1.56|||mixed-effects model|||||1.56|-12.93|0.078
91760709|NCT01620528|183413028|SUPERIORITY||LS Mean of Difference|-13.72|STANDARD_ERROR_OF_MEAN|3.249|<|0.001|TWO_SIDED|97.5|-21.01|-6.42|||mixed-effects model|||||-6.42|-21.01|< 0.001
91760710|NCT01620528|183413029|SUPERIORITY||LS Mean of Difference|-8.47|STANDARD_ERROR_OF_MEAN|3.475||0.015|TWO_SIDED|97.5|-16.27|-0.66|||mixed-effects model|||||-0.66|-16.27|0.015
91760711|NCT01620528|183413029|SUPERIORITY||LS Mean of Difference|-22.49|STANDARD_ERROR_OF_MEAN|3.514|<|0.001|TWO_SIDED|97.5|-30.38|-14.6|||mixed-effects model|||||-14.60|-30.38|< 0.001
91760712|NCT01620528|183413030|SUPERIORITY||LS Mean of Difference|-14.11|STANDARD_ERROR_OF_MEAN|3.673|<|0.001|TWO_SIDED|97.5|-22.36|-5.87|||mixed-effects model|||||-5.87|-22.36|< 0.001
91760713|NCT01620528|183413030|SUPERIORITY||LS Mean of Difference|-30.41|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-38.78|-22.04|||mixed-effects model|||||-22.04|-38.78|< 0.001
91760714|NCT01620528|183413031|SUPERIORITY||LS Mean of Difference|-11.55|STANDARD_ERROR_OF_MEAN|3.736||0.002|TWO_SIDED|97.5|-19.94|-3.16|||mixed-effects model|||||-3.16|-19.94|0.002
91760715|NCT01620528|183413031|SUPERIORITY||LS Mean of Difference|-29.68|STANDARD_ERROR_OF_MEAN|3.788|<|0.001|TWO_SIDED|97.5|-38.19|-21.18|||mixed-effects model|||||-21.18|-38.19|< 0.001
91760716|NCT01620528|183413032|SUPERIORITY||LS Mean of Difference|-12.37|STANDARD_ERROR_OF_MEAN|3.805||0.001|TWO_SIDED|97.5|-20.92|-3.83|||mixed-effects model|||||-3.83|-20.92|0.001
91760717|NCT01620528|183413032|SUPERIORITY||LS Mean of Difference|-29.97|STANDARD_ERROR_OF_MEAN|3.868|<|0.001|TWO_SIDED|97.5|-38.66|-21.28|||mixed-effects model|||||-21.28|-38.66|< 0.001
91760718|NCT01620528|183413033|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.038|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||||0.01|-0.22|0.038
91760719|NCT01620528|183413033|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.053||0.488|TWO_SIDED|97.5|-0.16|0.08|||mixed-effects model|||||0.08|-0.16|0.488
91760720|NCT01620528|183413034|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.252|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||||0.07|-0.20|0.252
91760721|NCT01620528|183413034|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.061||0.058|TWO_SIDED|97.5|-0.25|0.02|||mixed-effects model|||||0.02|-0.25|0.058
91760722|NCT01620528|183413035|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.069||0.009|TWO_SIDED|97.5|-0.34|-0.03|||mixed-effects model|||||-0.03|-0.34|0.009
91760723|NCT01620528|183413035|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.5|-0.18|||mixed-effects model|||||-0.18|-0.50|< 0.001
91760724|NCT01620528|183413036|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.073||0.06|TWO_SIDED|97.5|-0.3|0.03|||mixed-effects model|||||0.03|-0.30|0.060
91760725|NCT01620528|183413036|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.44|-0.1|||mixed-effects model|||||-0.10|-0.44|< 0.001
91760726|NCT01620528|183413037|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.074||0.118|TWO_SIDED|97.5|-0.28|0.05|||mixed-effects model|||||0.05|-0.28|0.118
91760727|NCT01620528|183413037|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|97.5|-0.48|-0.13|||mixed-effects model|||||-0.13|-0.48|< 0.001
91760728|NCT01620528|183413038|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.313|TWO_SIDED|97.5|-0.14|0.05|||mixed-effects model|||||0.05|-0.14|0.313
91760729|NCT01620528|183413038|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.044||0.006|TWO_SIDED|97.5|-0.22|-0.02|||mixed-effects model|||||-0.02|-0.22|0.006
91760730|NCT01620528|183413039|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.047||0.519|TWO_SIDED|97.5|-0.13|0.07|||mixed-effects model|||||0.07|-0.13|0.519
91760731|NCT01620528|183413039|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|97.5|-0.32|-0.11|||mixed-effects model|||||-0.11|-0.32|< 0.001
91760732|NCT01620528|183413040|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.053||0.037|TWO_SIDED|97.5|-0.23|0.01|||mixed-effects model|||||0.01|-0.23|0.037
91760733|NCT01620528|183413040|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.41|-0.17|||mixed-effects model|||||-0.17|-0.41|< 0.001
91760734|NCT01620528|183413041|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.053||0.2|TWO_SIDED|97.5|-0.19|0.05|||mixed-effects model|||||0.05|-0.19|0.200
91760735|NCT01620528|183413041|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.42|-0.18|||mixed-effects model|||||-0.18|-0.42|< 0.001
91760736|NCT01620528|183413042|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-0.72|-0.34|||ANOVA|||||-0.34|-0.72|< 0.001
91760737|NCT01620528|183413042|SUPERIORITY||LS Mean of Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.93|-0.56|||ANOVA|||||-0.56|-0.93|< 0.001
91760738|NCT01620528|183413043|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.58|-0.19|||ANOVA|||||-0.19|-0.58|< 0.001
91760739|NCT01620528|183413043|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-1.21|-0.82|||ANOVA|||||-0.82|-1.21|< 0.001
91760740|NCT01620528|183413044|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANOVA|||||-0.41|-0.81|< 0.001
91760741|NCT01620528|183413044|SUPERIORITY||LS Mean of Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.32|-0.92|||ANOVA|||||-0.92|-1.32|< 0.001
91760742|NCT01620528|183413045|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.83|-0.42|||ANOVA|||||-0.42|-0.83|< 0.001
91760743|NCT01620528|183413045|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|-1.47|-1.05|||ANOVA|||||-1.05|-1.47|< 0.001
91760744|NCT01620528|183413046|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.111|<|0.001|TWO_SIDED|95.0|-0.91|-0.48|||ANOVA|||||-0.48|-0.91|< 0.001
91760745|NCT01620528|183413046|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|-1.54|-1.1|||ANOVA|||||-1.10|-1.54|< 0.001
91760746|NCT01620528|183413047|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.96|-0.48|||ANOVA|||||-0.48|-0.96|< 0.001
91760747|NCT01620528|183413047|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.123|<|0.001|TWO_SIDED|95.0|-1.59|-1.11|||ANOVA|||||-1.11|-1.59|< 0.001
91760748|NCT01620528|183413048|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.109||0.011|TWO_SIDED|95.0|-0.52|-0.03|||mixed-effects model|||||-0.03|-0.52|0.011
91760749|NCT01620528|183413048|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|97.5|-0.65|-0.16|||mixed-effects model|||||-0.16|-0.65|< 0.001
91760750|NCT01620528|183413049|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.77|-0.16|||mixed-effects model|||||-0.16|-0.77|<0.001
91760751|NCT01620528|183413049|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.138||-0.96|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||||-0.65|-1.27|-0.96
91760752|NCT01620528|183413050|SUPERIORITY||LS Mean of Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|97.5|-1.17|-0.44|||mixed-effects model|||||-0.44|-1.17|< 0.001
91760753|NCT01620528|183413050|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.165|<|0.001|TWO_SIDED|97.5|-1.98|-1.24|||mixed-effects model|||||-1.24|-1.98|< 0.001
91760754|NCT01620528|183413051|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.167|<|0.001|TWO_SIDED|97.5|-1.05|-0.3|||mixed-effects model|||||-0.30|-1.05|< 0.001
91760755|NCT01620528|183413051|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|97.5|-1.99|-1.23|||mixed-effects model|||||-1.23|-1.99|< 0.001
91760756|NCT01620528|183413052|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.176|<|0.001|TWO_SIDED|97.5|-1.04|-0.25|||mixed-effects model|||||-0.25|-1.04|< 0.001
91760757|NCT01620528|183413052|SUPERIORITY||LS Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|97.5|-2.0|-1.2|||mixed-effects model|||||-1.20|-2.00|< 0.001
91760758|NCT01620528|183413053|SUPERIORITY||Difference in LS Means|-6.29|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|-9.37|-3.21|||ANCOVA|||||-3.21|-9.37|< 0.001
91760759|NCT01620528|183413053|SUPERIORITY||Difference in LS Means|-9.76|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.91|-6.61|||ANCOVA|||||-6.61|-12.91|< 0.001
91760760|NCT01620528|183413054|SUPERIORITY||Difference in LS Means|-9.28|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|-12.66|-5.91|||ANCOVA|||||-5.91|-12.66|< 0.001
91760761|NCT01620528|183413054|SUPERIORITY||Difference in LS Means|-18.75|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-22.22|-15.27|||ANCOVA|||||-15.27|-22.22|< 0.001
91760762|NCT01620528|183413055|SUPERIORITY||Difference in LS Means|-12.57|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-16.48|-8.66|||ANCOVA|||||-8.66|-16.48|< 0.001
91760763|NCT01620528|183413055|SUPERIORITY||Difference in LS Means|-25.1|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-29.12|-21.09|||ANCOVA|||||-21.09|-29.12|< 0.001
91760764|NCT01620528|183413056|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.94||0.685|TWO_SIDED|95.0|-4.59|3.02|||ANCOVA|||||3.02|-4.59|0.685
91760765|NCT01620528|183413056|SUPERIORITY||Difference in LS Means|-5.04|STANDARD_ERROR_OF_MEAN|2.03||0.013|TWO_SIDED|95.0|-9.04|-1.05|||ANCOVA|||||-1.05|-9.04|0.013
91760766|NCT01620528|183413057|SUPERIORITY||Difference in LS Means|-4.74|STANDARD_ERROR_OF_MEAN|2.39||0.047|TWO_SIDED|95.0|-9.43|-0.05|||ANCOVA|||||-0.05|-9.43|0.047
91760767|NCT01620528|183413057|SUPERIORITY||Difference in LS Means|-13.86|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.89|-8.84|||ANCOVA|||||-8.84|-18.89|< 0.001
91760768|NCT01620528|183413058|SUPERIORITY||Difference in LS Means|-4.71|STANDARD_ERROR_OF_MEAN|2.91||0.107|TWO_SIDED|95.0|-10.43|1.02|||ANCOVA|||||1.02|-10.43|0.107
91760769|NCT01620528|183413058|SUPERIORITY||Difference in LS Means|-17.51|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-23.52|-11.5|||ANCOVA|||||-11.50|-23.52|< 0.001
91760770|NCT01620528|183413059|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.741|TWO_SIDED|95.0|-0.61|0.85|||ANCOVA|||||0.85|-0.61|0.741
91760771|NCT01620528|183413059|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.38||0.002|TWO_SIDED|95.0|-1.9|-0.42|||ANCOVA|||||-0.42|-1.90|0.002
91760772|NCT01620528|183413060|SUPERIORITY||Difference in LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.172|TWO_SIDED|95.0|-1.16|0.21|||ANCOVA|||||0.21|-1.16|0.172
91517813|NCT01106833|182910124|SUPERIORITY|||||||0.105||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.105
91760773|NCT01620528|183413060|SUPERIORITY||Difference in LS Means|-1.27|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-1.97|-0.57|||ANCOVA|||||-0.57|-1.97|< 0.001
91760774|NCT01620528|183413061|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.43||0.016|TWO_SIDED|95.0|-1.9|-0.19|||ANCOVA|||||-0.19|-1.90|0.016
91760775|NCT01620528|183413061|SUPERIORITY||Difference in LS Means|-1.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-2.65|-0.91|||ANCOVA|||||-0.91|-2.65|< 0.001
91760776|NCT01620528|183413062|SUPERIORITY||Difference in LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.44||0.08|TWO_SIDED|95.0|-1.63|0.09|||ANCOVA|||||0.09|-1.63|0.080
91760777|NCT01620528|183413062|SUPERIORITY||Difference in LS Means|-1.37|STANDARD_ERROR_OF_MEAN|0.45||0.003|TWO_SIDED|95.0|-2.25|-0.48|||ANCOVA|||||-0.48|-2.25|0.003
91760778|NCT01620528|183413063|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.4||0.106|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||||0.14|-1.44|0.106
91760779|NCT01620528|183413063|SUPERIORITY||Difference in LS Means|-1.85|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.67|-1.02|||ANCOVA|||||-1.02|-2.67|< 0.001
91760780|NCT01620528|183413064|SUPERIORITY||Difference in LS Means|-0.75|STANDARD_ERROR_OF_MEAN|0.62||0.232|TWO_SIDED|95.0|-1.97|0.48|||ANCOVA|||||0.48|-1.97|0.232
91760781|NCT01620528|183413064|SUPERIORITY||Difference in LS Means|-2.21|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-3.48|-0.93|||ANCOVA|||||-0.93|-3.48|< 0.001
91760782|NCT01620528|183413065|SUPERIORITY||Difference in LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.37||0.013|TWO_SIDED|95.0|-1.65|-0.2|||ANCOVA|||||-0.20|-1.65|0.013
91760783|NCT01620528|183413065|SUPERIORITY||Difference in LS Means|-1.62|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.9|||ANCOVA|||||-0.90|-2.35|< 0.001
91760784|NCT01620528|183413066|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.47||0.005|TWO_SIDED|95.0|-2.24|-0.41|||ANCOVA|||||-0.41|-2.24|0.005
91760785|NCT01620528|183413066|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.56|-0.71|||ANCOVA|||||-0.71|-2.56|< 0.001
91760786|NCT01620528|183413067|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.53|-0.72|||ANCOVA|||||-0.72|-2.53|< 0.001
91760787|NCT01620528|183413067|SUPERIORITY||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.02|-1.19|||ANCOVA|||||-1.19|-3.02|< 0.001
91760788|NCT01620528|183413068|SUPERIORITY||Difference in LS Means|-1.21|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|-2.05|-0.38|||ANCOVA|||||-0.38|-2.05|0.004
91760789|NCT01620528|183413068|SUPERIORITY||Difference in LS Means|-2.23|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.06|-1.4|||ANCOVA|||||-1.40|-3.06|< 0.001
91760790|NCT01620528|183413069|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.39||0.013|TWO_SIDED|95.0|-1.74|-0.2|||ANCOVA|||||-0.20|-1.74|0.013
91760791|NCT01620528|183413069|SUPERIORITY||Difference in LS Means|-1.81|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.58|-1.04|||ANCOVA|||||-1.04|-2.58|< 0.001
91760792|NCT01620528|183413070|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.48||0.007|TWO_SIDED|95.0|-2.22|-0.34|||ANCOVA|||||-0.34|-2.22|0.007
91760793|NCT01620528|183413070|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.44|-1.54|||ANCOVA|||||-1.54|-3.44|< 0.001
91760794|NCT01620528|183413071|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.87||0.326|TWO_SIDED|95.0|-2.57|0.85|||ANCOVA|||||0.85|-2.57|0.326
91760795|NCT01620528|183413071|SUPERIORITY||Difference in LS Means|-1.93|STANDARD_ERROR_OF_MEAN|0.89||0.031|TWO_SIDED|95.0|-3.67|-0.18|||ANCOVA|||||-0.18|-3.67|0.031
91760796|NCT01620528|183413072|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.107|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||||0.31|-3.13|0.107
91760797|NCT01620528|183413072|SUPERIORITY||Difference in LS Means|-3.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.28|-1.75|||ANCOVA|||||-1.75|-5.28|< 0.001
91760798|NCT01620528|183413073|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.82||0.219|TWO_SIDED|95.0|-2.63|0.6|||ANCOVA|||||0.60|-2.63|0.219
91760799|NCT01620528|183413073|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-4.59|-1.28|||ANCOVA|||||-1.28|-4.59|< 0.001
91760800|NCT01620528|183413074|SUPERIORITY||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.72||0.026|TWO_SIDED|95.0|-3.01|-0.19|||ANCOVA|||||-0.19|-3.01|0.026
91760801|NCT01620528|183413074|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-5.34|-2.43|||ANCOVA|||||-2.43|-5.34|< 0.001
91760802|NCT01620528|183413075|SUPERIORITY||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.76||0.502|TWO_SIDED|95.0|-2.0|0.98|||ANCOVA|||||0.98|-2.00|0.502
91760803|NCT01620528|183413075|SUPERIORITY||Difference in LS Means|-3.13|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.7|-1.56|||ANCOVA|||||-1.56|-4.70|< 0.001
91760804|NCT01620528|183413076|SUPERIORITY||Difference in LS Means|-1.36|STANDARD_ERROR_OF_MEAN|0.85||0.108|TWO_SIDED|95.0|-3.02|0.3|||ANCOVA|||||0.30|-3.02|0.108
91760805|NCT01620528|183413076|SUPERIORITY||Difference in LS Means|-4.47|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.19|-2.74|||ANCOVA|||||-2.74|-6.19|< 0.001
91760806|NCT01620528|183413077|SUPERIORITY||Difference in LS Means|-1.19|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|-1.9|-0.48|||ANCOVA|||||-0.48|-1.90|0.001
91760807|NCT01620528|183413077|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.004|TWO_SIDED|95.0|-1.76|-0.34|||ANCOVA|||||-0.34|-1.76|0.004
91760808|NCT01620528|183413078|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.045|TWO_SIDED|95.0|-1.49|-0.02|||mixed-effects model|||||-0.02|-1.49|0.045
91760809|NCT01620528|183413078|SUPERIORITY||Difference in LS Means|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|-1.81|-0.31|||ANCOVA|||||-0.31|-1.81|0.006
91760810|NCT01620528|183413079|SUPERIORITY||Difference in LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.33||0.103|TWO_SIDED|95.0|-1.19|0.11|||ANCOVA|||||0.11|-1.19|0.103
91760811|NCT01620528|183413079|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|-1.64|-0.32|||ANCOVA|||||-0.32|-1.64|0.003
91760812|NCT01620528|183413080|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.36||0.39|TWO_SIDED|95.0|-1.01|0.4|||ANCOVA|||||0.40|-1.01|0.390
91760813|NCT01620528|183413080|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.003|TWO_SIDED|95.0|-1.75|-0.35|||ANCOVA|||||-0.35|-1.75|0.003
91760814|NCT01620528|183413081|SUPERIORITY||Difference in LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.46|TWO_SIDED|95.0|-0.72|0.32|||ANCOVA|||||0.32|-0.72|0.460
91760815|NCT01620528|183413081|SUPERIORITY||Difference in LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.52|||ANCOVA|||||-0.52|-1.57|< 0.001
91760816|NCT01620528|183413082|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.35||0.095|TWO_SIDED|95.0|-1.28|0.1|||ANCOVA|||||0.10|-1.28|0.095
91760817|NCT01620528|183413082|SUPERIORITY||Difference in LS Means|-1.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.01|-0.59|||ANCOVA|||||-0.59|-2.01|< 0.001
91760818|NCT01620528|183413083|SUPERIORITY||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.97||0.462|TWO_SIDED|95.0|-2.61|1.19|||ANCOVA|||||1.19|-2.61|0.462
91760819|NCT01620528|183413083|SUPERIORITY||Difference in LS Means|-3.23|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|-5.16|-1.3|||ANCOVA|||||-1.30|-5.16|0.001
91760820|NCT01620528|183413084|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|0.97||0.039|TWO_SIDED|95.0|-3.93|-0.11|||ANCOVA|||||-0.11|-3.93|0.039
91760821|NCT01620528|183413084|SUPERIORITY||Difference in LS Means|-4.86|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-6.82|-2.9|||ANCOVA|||||-2.90|-6.82|< 0.001
91760822|NCT01620528|183413085|SUPERIORITY||Difference in LS Means|-2.2|STANDARD_ERROR_OF_MEAN|1.03||0.032|TWO_SIDED|95.0|-4.21|-0.18|||ANCOVA|||||-0.18|-4.21|0.032
91760823|NCT01620528|183413085|SUPERIORITY||Difference in LS Means|-4.91|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-6.95|-2.86|||ANCOVA|||||-2.86|-6.95|< 0.001
91760824|NCT01620528|183413086|SUPERIORITY||Difference in LS Means|-2.42|STANDARD_ERROR_OF_MEAN|0.94||0.01|TWO_SIDED|95.0|-4.26|-0.58|||ANCOVA|||||-0.58|-4.26|0.010
91760825|NCT01620528|183413086|SUPERIORITY||Difference in LS Means|-5.25|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-7.14|-3.36|||ANCOVA|||||-3.36|-7.14|< 0.001
91760826|NCT01620528|183413087|SUPERIORITY||Difference in LS Means|-1.17|STANDARD_ERROR_OF_MEAN|0.94||0.215|TWO_SIDED|95.0|-3.02|0.68|||ANCOVA|||||0.68|-3.02|0.215
91760827|NCT01620528|183413087|SUPERIORITY||Difference in LS Means|-5.13|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-7.06|-3.2|||ANCOVA|||||-3.20|-7.06|< 0.001
91760828|NCT01620528|183413088|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|1.16||0.053|TWO_SIDED|95.0|-4.53|0.03|||ANCOVA|||||0.03|-4.53|0.053
91760829|NCT01620528|183413088|SUPERIORITY||Difference in LS Means|-6.79|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.17|-4.41|||ANCOVA|||||-4.41|-9.17|< 0.001
91760830|NCT01620528|183413089|SUPERIORITY||Difference in LS Means|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.24|-1.01|||ANCOVA|||||-1.01|-3.24|< 0.001
91760831|NCT01620528|183413089|SUPERIORITY||Difference in LS Means|-2.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.71|-1.49|||ANCOVA|||||-1.49|-3.71|< 0.001
91760832|NCT01620528|183413090|SUPERIORITY||Difference in LS Means|-2.09|STANDARD_ERROR_OF_MEAN|0.67||0.002|TWO_SIDED|95.0|-3.4|-0.78|||ANCOVA|||||-0.78|-3.40|0.002
91760833|NCT01620528|183413090|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-3.98|-1.32|||ANCOVA|||||-1.32|-3.98|< 0.001
91760834|NCT01620528|183413091|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-3.39|-0.95|||ANCOVA|||||-0.95|-3.39|< 0.001
91760835|NCT01620528|183413091|SUPERIORITY||Difference in LS Means|-3.0|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.23|-1.76|||ANCOVA|||||-1.76|-4.23|< 0.001
91760836|NCT01620528|183413092|SUPERIORITY||Difference in LS Means|-1.54|STANDARD_ERROR_OF_MEAN|0.64||0.017|TWO_SIDED|95.0|-2.8|-0.27|||ANCOVA|||||-0.27|-2.80|0.017
91760837|NCT01620528|183413092|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.5|-1.98|||ANCOVA|||||-1.98|-4.50|< 0.001
91760838|NCT01620528|183413093|SUPERIORITY||Difference in LS Means|-1.14|STANDARD_ERROR_OF_MEAN|0.55||0.038|TWO_SIDED|95.0|-2.22|-0.07|||ANCOVA|||||-0.07|-2.22|0.038
91760839|NCT01620528|183413093|SUPERIORITY||Difference in LS Means|-2.83|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.91|-1.74|||ANCOVA|||||-1.74|-3.91|< 0.001
91760840|NCT01620528|183413094|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|0.66||0.006|TWO_SIDED|95.0|-3.13|-0.54|||ANCOVA|||||-0.54|-3.13|0.006
91760841|NCT01620528|183413094|SUPERIORITY||Difference in LS Means|-3.75|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-5.06|-2.44|||ANCOVA|||||-2.44|-5.06|< 0.001
91535627|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.56|STANDARD_ERROR_OF_MEAN|3.22|<|0.0001|TWO_SIDED|95.0|-20.93|-8.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.19|-20.93|<0.0001
91535628|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.11|STANDARD_ERROR_OF_MEAN|3.2||0.0584|TWO_SIDED|95.0|-12.43|0.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.22|-12.43|0.0584
91535629|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.45|STANDARD_ERROR_OF_MEAN|3.19||0.009|TWO_SIDED|95.0|-14.76|-2.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.15|-14.76|0.0090
91535630|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.69|STANDARD_ERROR_OF_MEAN|2.28||0.2405|TWO_SIDED|95.0|-7.2|1.82||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.82|-7.20|0.2405
91535631|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.26||0.7565|TWO_SIDED|95.0|-5.18|3.77||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.77|-5.18|0.7565
91535632|NCT00991276|182949771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|2.25||0.3792|TWO_SIDED|95.0|-6.43|2.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.47|-6.43|0.3792
91535633|NCT00991276|182949772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.27|STANDARD_ERROR_OF_MEAN|1.66||0.0019|TWO_SIDED|95.0|1.98|8.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.55|1.98|0.0019
91535634|NCT00991276|182949772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|1.65||0.0506|TWO_SIDED|95.0|-0.01|6.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.51|-0.01|0.0506
91535635|NCT00991276|182949772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.64||0.2222|TWO_SIDED|95.0|-1.24|5.26||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.26|-1.24|0.2222
91535636|NCT01268891|182949779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.3257|TWO_SIDED|90.0|-0.93|0.23||The threshold for statistical significance in showing a trend for this study is 0.10.|ANCOVA|||The power for this study, which is designed to show a trend, that is, to show a clinical difference in the primary outcome measure, is 72%.||0.23|-0.93|0.3257
91535637|NCT01268891|182949780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0946|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||||0.05|-0.65|0.0946
91535638|NCT01268891|182949781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2258|TWO_SIDED|95.0|-1.84|0.44|||ANCOVA|||||0.44|-1.84|0.2258
91535639|NCT01268891|182949782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.98||0.17|TWO_SIDED|95.0|-3.29|0.59|||ANCOVA|||||0.59|-3.29|0.1700
91535640|NCT00959920|182949814|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.8||||0.42|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.||||.42
91535641|NCT01107626|182949827|SUPERIORITY|||||||0.12|||||||Log Rank|Stratified logrank test||||||0.12
91760842|NCT04569357|183413098|SUPERIORITY|||||||0.0199|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 25%.||||0.0199
91760843|NCT04569357|183413099|SUPERIORITY|||||||0.0096|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores after 8 weeks of treatment were compared.||||0.0096
91760844|NCT04569357|183413100|SUPERIORITY|||||||0.0063|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (attention deficit subscale) after 8 weeks of treatment were compared.||||0.0063
91760845|NCT04569357|183413101|SUPERIORITY|||||||0.0525|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (hyperactivity/impulsivity subscale) after 8 weeks of treatment were compared.||||0.0525
91760846|NCT04569357|183413102|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect analysis.||||0.0024
91760847|NCT04569357|183413102|SUPERIORITY|||||||0.1722|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.1722
91760848|NCT04569357|183413102|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.0012
91760849|NCT04569357|183413103|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
91760850|NCT04569357|183413104|SUPERIORITY|||||||0.81||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Systolic pressure data.||||0.81
91760851|NCT04569357|183413104|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Diastolic pressure data.||||0.22
91760852|NCT04569357|183413105|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
91760853|NCT04569357|183413106|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.2
91760854|NCT04569357|183413107|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
91760855|NCT04569357|183413108|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.5
91760856|NCT04569357|183413109|SUPERIORITY|||||||0.0254|||||||Fisher Exact|||||||0.0254
91760857|NCT01122849|183413110|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|-0.12||||0.5456|TWO_SIDED|95.0|-0.52|0.28||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.28|-0.52|0.5456
91760858|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.1029|TWO_SIDED|95.0|-0.75|0.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.07|-0.75|0.1029
91760859|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.2879|TWO_SIDED|95.0|-0.19|0.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.62|-0.19|0.2879
91760860|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8213|TWO_SIDED|95.0|-0.45|0.56||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.56|-0.45|0.8213
91760861|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24||||0.3457||95.0|-0.74|0.27||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.27|-0.74|0.3457
91760862|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2364|TWO_SIDED|95.0|-0.2|0.79|||ANCOVA|||Comparison for Q3 at Day 7||0.79|-0.20|0.2364
91760863|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.3553|TWO_SIDED|95.0|-0.21|0.57||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.57|-0.21|0.3553
91760864|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.3369|TWO_SIDED|95.0|-0.58|0.2||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.20|-0.58|0.3369
91760865|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.0591|TWO_SIDED|95.0|-0.01|0.76||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.76|-0.01|0.0591
91760866|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7686|TWO_SIDED|95.0|-0.42|0.31||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q18 at Day 7||0.31|-0.42|0.7686
91760867|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46||||0.0151|TWO_SIDED|95.0|-0.83|-0.09|||ANCOVA|||Comparison of Q18 at Day 7||-0.09|-0.83|0.0151
91760868|NCT01122849|183413110|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0256|TWO_SIDED|95.0|0.05|0.77||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 7||0.77|0.05|0.0256
91760869|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.5958|TWO_SIDED|95.0|-0.52|0.3||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1at Day 14||0.30|-0.52|0.5958
91760870|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1429|TWO_SIDED|95.0|-0.73|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 14||0.11|-0.73|0.1429
91760871|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.3348|TWO_SIDED|95.0|-0.21|0.62|||ANCOVA|||Comparison of Q1 at Day 14||0.62|-0.21|0.3348
91760872|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.4425||95.0|-0.32|0.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.72|-0.32|0.4425
91760873|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.4795|TWO_SIDED|95.0|-0.71|0.34|||ANCOVA|||Comparison of Q3 at Day 14||0.34|-0.71|0.4795
91760874|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.1375|TWO_SIDED|95.0|-0.13|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.90|-0.13|0.1375
91760875|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.575|TWO_SIDED|95.0|-0.56|0.31||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.31|-0.56|0.5750
91760876|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.0337|TWO_SIDED|95.0|-0.92|-0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||-0.04|-0.92|0.0337
91760877|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1061|TWO_SIDED|95.0|-0.08|0.79||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.79|-0.08|0.1061
91760878|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.7092|TWO_SIDED|95.0|-0.5|0.34||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 14||0.34|-0.50|0.7092
91760879|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49||||0.025|TWO_SIDED|95.0|-0.91|-0.06||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day14||-0.06|-0.91|0.0250
91760880|NCT01122849|183413111|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0503|TWO_SIDED|95.0|0.0|0.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q18 at Day 14||0.82|0.00|0.0503
91760881|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.5462|TWO_SIDED|95.0|-1.92|3.59||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 7||3.59|-1.92|0.5462
91760882|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.37||||0.0942|TWO_SIDED|95.0|-5.16|0.42||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for sleep problems at Day 7||0.42|-5.16|0.0942
91760883|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.0221|TWO_SIDED|95.0|0.48|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep problems at Day 7||5.93|0.48|0.0221
91760884|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean difference|-0.72||||0.6731|TWO_SIDED|95.0|-4.11|2.68||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Sleep Time problems at Day 7||2.68|-4.11|0.6731
91760885|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57||||0.1354|TWO_SIDED|95.0|-5.98|0.83||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Sleep time problems at Day 7||0.83|-5.98|0.1354
91760886|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean difference|1.86||||0.2722|TWO_SIDED|95.0|-1.5|5.21||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep time problems at Day 7||5.21|-1.50|0.2722
91760887|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean difference|-0.71||||0.6195|TWO_SIDED|95.0|-3.55|2.14||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on walking in the morning at Day 7||2.14|-3.55|0.6195
91760888|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.83||||0.0099|TWO_SIDED|95.0|-6.7|-0.96||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at day 7 for symptoms for walking in the morning||-0.96|-6.70|0.0099
91760889|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean Difference|3.12||||0.0298|TWO_SIDED|95.0|0.32|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 7||5.93|0.32|0.0298
91760890|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3||||0.7211|TWO_SIDED|95.0|-2.01|1.4||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||1.40|-2.01|0.7211
91760891|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean difference|-0.8||||0.35|TWO_SIDED|95.0|-2.51|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||0.90|-2.51|0.3500
91760892|NCT01122849|183413112|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.5564|TWO_SIDED|95.0|-1.19|2.18||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||2.18|-1.19|0.5564
91760893|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.6804|TWO_SIDED|95.0|-2.2|3.35||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Sleep Problems at Day 14||3.35|-2.20|0.6804
91760894|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.31||||0.3524|TWO_SIDED|95.0|-4.12|1.49||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||1.49|-4.12|0.3524
91760895|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean Difference|1.89||||0.1739|TWO_SIDED|95.0|-0.86|4.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||4.63|-0.86|0.1739
91760896|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean difference|1.98||||0.2463|TWO_SIDED|95.0|-1.41|5.36||Between treatment p-values and confidence intervals|ANCOVA|Between treatment p-values and confidence intervals||Comparison for Sleep time problems at Day 14||5.36|-1.41|0.2463
91760897|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean difference|0.28||||0.8677|TWO_SIDED|95.0|-3.11|3.68|||ANCOVA|||Comparison for sleep time problems at Day 14||3.68|-3.11|0.8677
91760898|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.3136|TWO_SIDED|95.0|-1.65|5.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep time problems at Day 14||5.04|-1.65|0.3136
91760899|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.9183|TWO_SIDED|95.0|-2.93|2.65||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||2.65|-2.93|0.9183
91760900|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean difference|-2.68||||0.0614|TWO_SIDED|95.0|-5.5|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||0.13|-5.50|0.0614
91760901|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean Difference|2.54||||0.0695|TWO_SIDED|95.0|-0.21|5.29||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||5.29|-0.21|0.0695
91760902|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.4947|TWO_SIDED|95.0|-1.03|2.1||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day14||2.10|-1.03|0.4947
91760903|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean difference|0.15||||0.8454|TWO_SIDED|95.0|-1.42|1.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.72|-1.42|0.8454
91535642|NCT01107626|182949827|SUPERIORITY|||||||0.28|||||||Log Rank|Stratified logrank test||||||0.28
91760904|NCT01122849|183413113|SUPERIORITY_OR_OTHER||LS Mean difference|0.38||||0.6223|TWO_SIDED|95.0|-1.17|1.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.93|-1.17|0.6223
91760905|NCT01122849|183413114|SUPERIORITY_OR_OTHER||LS Mean difference|-1.34||||0.4258|TWO_SIDED|95.0|-4.68|2.01||Between treatment p-values and confidence intervals|LS Mean Difference|||Comparison at Day 7||2.01|-4.68|0.4258
91760906|NCT01122849|183413114|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05||||0.0764|TWO_SIDED|95.0|-6.43|0.33||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||0.33|-6.43|0.0764
91760907|NCT01122849|183413114|SUPERIORITY_OR_OTHER||LS Mean Difference|1.71||||0.2986|TWO_SIDED|95.0|-1.56|4.97||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||4.97|-1.56|0.2986
91760908|NCT01122849|183413115|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.482|TWO_SIDED|95.0|-2.05|4.29||Between treatment p-values and confidence intervals|ANCOVA|||||4.29|-2.05|0.4820
91760909|NCT01122849|183413115|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.81||||0.2607|TWO_SIDED|95.0|-5.02|1.39||Between treatment p-values and confidence intervals|ANCOVA|||||1.39|-5.02|0.2607
91760910|NCT01122849|183413115|SUPERIORITY_OR_OTHER||LS Mean Difference|2.93||||0.0623|TWO_SIDED|95.0|-0.16|6.02||Between treatment p-values and confidence intervals|ANCOVA|||||6.02|-0.16|0.0623
91760911|NCT01122849|183413116|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.36||||0.5278|TWO_SIDED|95.0|-18.1|9.39||Between treatment p-values and confidence intervals|ANCOVA|||||9.39|-18.1|0.5278
91760912|NCT01122849|183413116|SUPERIORITY_OR_OTHER||LS Mean Difference|10.14||||0.1458|TWO_SIDED|95.0|-3.64|23.93||Between treatment p-values and confidence intervals|ANCOVA|||||23.93|-3.64|0.1458
91760913|NCT01122849|183413116|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.5||||0.037|TWO_SIDED|95.0|-28.1|-0.91||Between treatment p-values and confidence intervals.|ANCOVA|||||-0.91|-28.1|0.0370
91760914|NCT01122849|183413117|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1||||0.4483|TWO_SIDED|95.0|-18.5|8.29|||ANCOVA|Between treatment p-values and confidence intervals||||8.29|-18.5|0.4483
91760915|NCT01122849|183413117|SUPERIORITY_OR_OTHER||LS Mean Difference|14.28||||0.0385|TWO_SIDED|95.0|0.79|27.77|||ANCOVA|Between treatment p-values and confidence intervals||||27.77|0.79|0.0385
91760916|NCT01122849|183413117|SUPERIORITY_OR_OTHER||LS Mean difference|-19.37||||0.0046|TWO_SIDED|95.0|-32.5|-6.23|||ANCOVA|Between treatment p-values and confidence intervals||||-6.23|-32.5|0.0046
91760917|NCT01122849|183413118|SUPERIORITY_OR_OTHER||LS Mean Difference|15.24||||0.0029|TWO_SIDED|95.0|5.45|25.02||Between treatment p-values and confidence intervals|ANCOVA|||||25.02|5.45|0.0029
91760918|NCT01122849|183413118|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74||||0.4683|TWO_SIDED|95.0|-6.53|14.01||Between treatment p-values and confidence intervals|ANCOVA|||||14.01|-6.53|0.4683
91760919|NCT01122849|183413118|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0259|TWO_SIDED|95.0|1.44|21.55||Between treatment p-values and confidence intervals|ANCOVA|||||21.55|1.44|0.0259
91760920|NCT01122849|183413119|SUPERIORITY_OR_OTHER||LS Mean Difference|7.79||||0.1764|TWO_SIDED|95.0|-3.62|19.19||Between treatment p-values and confidence intervals|ANCOVA|||||19.19|-3.62|0.1764
91760921|NCT01122849|183413119|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.9183|TWO_SIDED|95.0|-11.7|12.94||Between treatment p-values and confidence intervals|ANCOVA|||||12.94|-11.7|0.9183
91760922|NCT01122849|183413119|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.2313||95.0|-4.7|19.01||Between treatment p-values and confidence intervals|ANCOVA|||||19.01|-4.70|0.2313
91760923|NCT01122849|183413120|SUPERIORITY_OR_OTHER||LS Mean difference|0.27||||0.1345|TWO_SIDED|95.0|-0.09|0.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.63|-0.09|0.1345
91760924|NCT01122849|183413120|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.0815|TWO_SIDED|95.0|-0.68|0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.04|-0.68|0.0815
91760925|NCT01122849|183413120|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.0015|TWO_SIDED|95.0|0.24|0.94||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.94|0.24|0.0015
91760926|NCT01122849|183413120|SUPERIORITY_OR_OTHER||LS mean differnence|-1.03||||0.0292||95.0|-1.96|-0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.11|-1.96|0.0292
91760927|NCT01122849|183413120|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.2497|TWO_SIDED|95.0|-0.39|1.47||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.47|-0.39|0.2497
91760928|NCT01122849|183413120|SUPERIORITY_OR_OTHER||LS Mean difference|-1.57||||0.0011|TWO_SIDED|95.0|-2.48|-0.66||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.66|-2.48|0.0011
91760929|NCT01122849|183413121|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8063|TWO_SIDED|95.0|-0.4|0.51||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.51|-0.40|0.8063
91760930|NCT01122849|183413121|SUPERIORITY_OR_OTHER||LS Mean Differnence|-0.35||||0.1356|TWO_SIDED|95.0|-0.82|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.11|-0.82|0.1356
91760931|NCT01122849|183413121|SUPERIORITY_OR_OTHER||LS mean Difference|0.41||||0.0786|TWO_SIDED|95.0|-0.05|0.87|||ANCOVA|||Comparison for Q2 at Day 14||0.87|-0.05|0.0786
91760932|NCT01122849|183413121|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72||||0.1693|TWO_SIDED|95.0|-1.75|0.32||Between treatment p-values and confidence intervals|ANCOVA|||Comparisons for Q4 at Day 14||0.32|-1.75|0.1693
91760933|NCT01122849|183413121|SUPERIORITY_OR_OTHER||LS Mean difference|1.08||||0.0438|TWO_SIDED|95.0|0.03|2.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.13|0.03|0.0438
91760934|NCT01122849|183413121|SUPERIORITY_OR_OTHER||LS Mean difference|-1.8||||0.0009|TWO_SIDED|95.0|-2.82|-0.78||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||-0.78|-2.82|0.0009
91760935|NCT01122849|183413122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.1991|TWO_SIDED|95.0|-0.62|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.13|-0.62|0.1991
91760936|NCT01122849|183413122|SUPERIORITY_OR_OTHER||LS Mean difference|-0.21||||0.2964|TWO_SIDED|95.0|-0.6|0.19||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.19|-0.60|0.2964
91760937|NCT01122849|183413122|SUPERIORITY_OR_OTHER||LS mean difference|-0.04||||0.8495|TWO_SIDED|95.0|-0.42|0.35||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.35|-0.42|0.8495
91760938|NCT01122849|183413122|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.0381|TWO_SIDED|95.0|0.08|2.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||2.62|0.08|0.0381
91760939|NCT01122849|183413122|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.4005|TWO_SIDED|95.0|-0.74|1.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.82|-0.74|0.4005
91760940|NCT01122849|183413122|SUPERIORITY_OR_OTHER||LS mean difference|0.81||||0.202|TWO_SIDED|95.0|-0.45|2.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||2.07|-0.45|0.2020
91760941|NCT01122849|183413123|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.5741|TWO_SIDED|95.0|-0.41|0.23||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.23|-0.41|0.5741
91760942|NCT01122849|183413123|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.6935|TWO_SIDED|95.0|-0.26|0.39||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.39|-0.26|0.6935
91760943|NCT01122849|183413123|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.333|TWO_SIDED|95.0|-0.47|0.16||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q2 at Day 14||0.16|-0.47|0.3330
91760944|NCT01122849|183413123|SUPERIORITY_OR_OTHER||LS Mean difference|1.39||||0.0434|TWO_SIDED|95.0|0.04|2.73||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.73|0.04|0.0434
91760945|NCT01122849|183413123|SUPERIORITY_OR_OTHER||LS Mean difference|0.32||||0.6333|TWO_SIDED|95.0|-1.02|1.67||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||1.67|-1.02|0.6333
91760946|NCT01122849|183413123|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.1091|TWO_SIDED|95.0|-0.25|2.37||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Q4 at Day 14||2.37|-0.25|0.1091
91760947|NCT01457846|183413137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.57||||0.9581|TWO_SIDED|80.0|1.12|2.21||1-sided|Regression, Cox|||||2.21|1.12|0.9581
91760948|NCT01457846|183413138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.8156|TWO_SIDED|80.0|0.89|1.95||1-sided|Regression, Cox|||||1.95|0.89|0.8156
91760949|NCT01457846|183413139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.997|TWO_SIDED|80.0|0.02|0.35||1-sided|Regression, Logistic|||||0.35|0.02|0.9970
91760950|NCT00383162|183413142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.001||95.0|2.17|9.36|||Generalized Estimating Equations|||||9.36|2.17|<0.001
91760951|NCT03533244|183413199|SUPERIORITY|||||||0.218||||||To reserve the family-wise error rate, the main treatment effect will be first assessed at the global level at alpha = 0.05. If this is significant, then pairwise comparisons will be conducted using the Bonferroni adjustment for multiplicity.|Mixed Models Analysis|||An empirical sample size estimation was used as this was an exploratory study. The null hypothesis is that there is no difference between AG-86893 and AG-86893 Vehicle. It is expected that the active group is at least 50% better than the vehicle.||||0.218
91760952|NCT03533244|183413199|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.290
91760953|NCT03533244|183413200|SUPERIORITY|||||||0.193|||||||Mixed Models Analysis|||||||0.193
91760954|NCT03533244|183413200|SUPERIORITY|||||||0.399|||||||Mixed Models Analysis|||||||0.399
91760955|NCT03533244|183413201|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
91760956|NCT03533244|183413201|SUPERIORITY|||||||0.022|||||||Fisher Exact|||||||0.022
91760957|NCT03368235|183413248|OTHER||LS mean difference|0.472|STANDARD_ERROR_OF_MEAN|0.4569||0.315|TWO_SIDED|95.0|-0.487|1.431||Based on MMRM model with the baseline DAS28-CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||MMRM = mixed model repeated measures.||1.431|-0.487|0.315
91760958|NCT03368235|183413249|OTHER||Odds Ratio (OR)|0.807||||0.807|TWO_SIDED|95.0|0.12|5.34||Logistic regression model with the treatment group, country and baseline DAS28-CRP as covariate.|Regression, Logistic|||Treatment comparison ACR20: AZD9567 Vs prednisolone||5.34|0.12|0.807
91760959|NCT03368235|183413249|OTHER|||||||0.198|||||||Fisher Exact|||Treatment comparison ACR50: AZD9567 Vs prednisolone||||0.198
91760960|NCT03368235|183413249|OTHER|||||||0.183|||||||Fisher Exact|||Treatment comparison ACR70: AZD9567 Vs prednisolone||||0.183
91760961|NCT03368235|183413250|OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.136||0.717|TWO_SIDED|95.0|-1.98|2.81||The MMRM with the baseline SJC66 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.81|-1.98|0.717
91760962|NCT03368235|183413251|OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|3.115||0.724|TWO_SIDED|95.0|-7.69|5.46||The MMRM with the baseline TJC68 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||5.46|-7.69|0.724
91760963|NCT03368235|183413252|OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.6||0.973|TWO_SIDED|95.0|-3.43|3.32||The MMRM with the baseline TJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||3.32|-3.43|0.973
91760964|NCT03368235|183413253|OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.837||0.757|TWO_SIDED|95.0|-1.5|2.03||The MMRM with the baseline SJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.03|-1.50|0.757
91760965|NCT03368235|183413254|OTHER||LS mean difference|9.8|STANDARD_ERROR_OF_MEAN|9.67||0.325|TWO_SIDED|95.0|-10.5|30.1||The MMRM with the baseline GH score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||30.1|-10.5|0.325
91760966|NCT03368235|183413255|OTHER||LS mean difference|4.756|STANDARD_ERROR_OF_MEAN|3.4725||0.187|TWO_SIDED|95.0|-2.514|12.025||The MMRM with the baseline CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||12.025|-2.514|0.187
91760967|NCT03368235|183413256|OTHER||LS mean difference|16.0|STANDARD_ERROR_OF_MEAN|10.49||0.144|TWO_SIDED|95.0|-6.0|38.1||The MMRM with the baseline participant's assessment of pain score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||38.1|-6.0|0.144
91760968|NCT03368235|183413257|OTHER||LS mean difference|3.8|STANDARD_ERROR_OF_MEAN|5.73||0.512|TWO_SIDED|95.0|-8.3|16.0||The MMRM with the baseline disease activity score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||16.0|-8.3|0.512
91760969|NCT03368235|183413258|OTHER||LS mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.2381||0.589|TWO_SIDED|95.0|-0.37|0.631||The MMRM with the baseline physical function score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||0.631|-0.370|0.589
91760970|NCT01743040|183413264|NON_INFERIORITY|15% equivalency margin against performance of SPECT nuclear stress test OPC. Both sensitivity and specificity were measured and the equivalency margin was set the same for both parameters.The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||||0.012|||||||Exact binomial test|||The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||0.012
91760971|NCT00825812|183413293|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|5.7||||||95.0|4.9|6.6|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|The primary analysis was the comparison of the two treatments among Chinese subjects.||6.6|4.9|
91760972|NCT00825812|183413293|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|4.8||||||97.5|3.7|6.0|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|A key secondary analysis was the comparison of the two treatments among Caucasian subjects.||6.0|3.7|
91760973|NCT00825812|183413293|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds.|median difference (seconds)|7.0||||||97.5|-5.0|21.0|||||Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex).|A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects.||21|-5|
91760974|NCT00986362|183413300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.613||||0.679|TWO_SIDED|95.0|0.07|4.509|||Fisher Exact|||||4.509|0.070|0.679
91760975|NCT03755661|183413304|OTHER|pilot data to estimate effect size f-squared as the parameter as primary outcome||||||0.048||||||provide inferential statistics for data completion. Study is not designed to detect significant differences between groups|Regression, Linear|R-square change = .12; F-change (1, 20) = 4.44||pilot study to calculate effect size, study is not powered to detect significant group differences|"Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2~f- squared = .22"|||.048
91760976|NCT03755661|183413305|SUPERIORITY|"The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.~A statistical test is provided only for completeness as this study is not powered to detect significant effects"||||||0.34||||||F-change (1, 20) = 0.97|Regression, Linear|||pilot trial to compute effect size estimate|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.34
91760977|NCT03755661|183413306|SUPERIORITY|This is a pilot trial to estimate effect sizes and not powered to detect significant differences||||||0.2||||||data provided for completeness, not powered to test differences|Regression, Linear|F-change (1, 20) = 1.80|||Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058|||.20
91760978|NCT03755661|183413307|SUPERIORITY|Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates||||||0.19|||||||Regression, Linear|F-change (1, 20) = 1.83||Pilot trial not powered to detect significant group differences|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048|||.19
91760979|NCT03755661|183413308|SUPERIORITY|||||||0.26||||||F-change (1, 19) = 1.34|Regression, Linear|||Not powered to test significant differences. provide data on effect size estimate below|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.26
91760980|NCT02038075|183413309|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.38||||0.02|TWO_SIDED|95.0|0.16|0.87|||Regression, Cox|||To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.||.87|.16|.02
91760981|NCT04000581|183413319|SUPERIORITY|||||||0.329|||||||t-test, 1 sided|||The null hypothesis is that the mean change is equal between the groups, while the alternative is that an increased difference is observed in arm 2. The hypotheses are evaluated using a one-sided, two-sample t-test.||||0.329
91760982|NCT02519595|183413333|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
91760983|NCT02519595|183413334|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
91760984|NCT02519595|183413335|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
91760985|NCT02519595|183413337|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Adverse events in ED||||0.8
91760986|NCT02519595|183413337|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||Post discharge Emesis||||0.5
91760987|NCT02519595|183413338|SUPERIORITY_OR_OTHER|||||||0.011|||||||Chi-squared|||||||0.011
91760988|NCT00387036|183413339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.59|-0.25||||||||-0.25|-1.59|
91760989|NCT00387036|183413340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|1.9||||90.0|-0.28|6.61||||||||6.61|-0.28|
91760990|NCT03188510|183413341|OTHER||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.805|1.17||||||||1.17|0.805|
91760991|NCT03188510|183413341|OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.841|1.22||||||||1.22|0.841|
91760992|NCT03188510|183413341|OTHER||Ratio of geometric least squares means|0.985|||||TWO_SIDED|90.0|0.819|1.18||||||||1.18|0.819|
91760993|NCT03188510|183413342|OTHER||Ratio of geometric least squares means|0.978|||||TWO_SIDED|90.0|0.811|1.18||||||||1.18|0.811|
91760994|NCT03188510|183413342|OTHER||Ratio of geometric least squares means|1.0|||||TWO_SIDED|90.0|0.833|1.21||||||||1.21|0.833|
91760995|NCT03188510|183413342|OTHER||Ratio of geometric least squares means|0.982|||||TWO_SIDED|90.0|0.817|1.18||||||||1.18|0.817|
91760996|NCT01736618|183413351|OTHER||Kaplan-Meier|92.9|||||ONE_SIDED|95.0|91.4|||||||"Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the performance goal of 85.0%.~Ho: p1 ≤ 85.0% Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance goal of 85.0%.~Ha: p1 \> 85.0% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 85.0%."|||91.4|
91760997|NCT01736618|183413352|OTHER||Clopper-Pearson exact confidence bound|98.6|||||ONE_SIDED|95.0|97.4|||||||"Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance goal of 94.0%.~Ho: p1 ≤ 94.0% Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 94.0%.~Ha: p1 \>94.0% The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 94.0%."|||97.4|
91760998|NCT01736618|183413353|OTHER||Kaplan-Meier|99.2|||||ONE_SIDED|95.0|98.8|||||||"Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the performance goal of 92.5%.~Ho: p1 ≤ 92.5% Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the performance goal of 92.5%.~Ha: p1 \> 92.5% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 92.5%."|||98.8|
91760999|NCT01736618|183413354|OTHER||Clopper-Pearson exact confidence bound|94.4|||||ONE_SIDED|95.0|93.5|||||||"Ho: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does not exceed the performance goal of 84.0%.~Ho: p1 ≤ 84.0% Ha: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does exceed the performance goal of 84.0%.~Ha: p1 \>84.0% The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 84.0%."|||93.5|
91761000|NCT04167137|183413363|OTHER|||||||||||||||||Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|||
91761001|NCT03058692|183413380|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
91761002|NCT03058692|183413380|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
91761003|NCT03058692|183413381|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
91761004|NCT03058692|183413381|OTHER|||||||0.73||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.73
91761005|NCT03058692|183413382|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
91761006|NCT03058692|183413382|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
91761007|NCT03058692|183413383|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
91761008|NCT03058692|183413383|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
91761009|NCT03058692|183413384|OTHER|||||||0.0078||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0078
91761010|NCT03058692|183413384|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
91761011|NCT03058692|183413385|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
91761012|NCT03058692|183413385|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
91761013|NCT03058692|183413386|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
91761014|NCT03058692|183413386|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
91761015|NCT03058692|183413387|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
91761016|NCT03058692|183413388|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
91761017|NCT03058692|183413388|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
91761018|NCT03058692|183413389|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
91761019|NCT03058692|183413389|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
91761020|NCT03058692|183413390|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
91761021|NCT03058692|183413390|OTHER|||||||0.9||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.90
91761022|NCT03058692|183413391|OTHER|||||||0.87||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.87
91761023|NCT03058692|183413391|OTHER|||||||0.57||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.57
91761024|NCT03058692|183413392|OTHER|||||||0.82||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.82
91761025|NCT03058692|183413392|OTHER|||||||0.076||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.076
91761026|NCT03058692|183413393|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
91761027|NCT03058692|183413393|OTHER|||||||0.75||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.75
91761028|NCT03058692|183413394|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
91761029|NCT03058692|183413394|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
91761030|NCT03058692|183413395|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
91761031|NCT03058692|183413395|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
91761032|NCT03058692|183413396|OTHER|||||||0.81||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.81
91761033|NCT03058692|183413396|OTHER|||||||0.47||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.47
91761034|NCT03058692|183413397|OTHER|||||||0.0061||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0061
91761035|NCT03058692|183413397|OTHER|||||||0.28||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.28
91761036|NCT03058692|183413398|OTHER|||||||0.36||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.36
91761037|NCT03058692|183413398|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
91761038|NCT03058692|183413399|OTHER|||||||0.42||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.42
91761039|NCT03058692|183413399|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
91761040|NCT03058692|183413400|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
91761041|NCT03058692|183413400|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
91761042|NCT03058692|183413401|OTHER|||||||0.97||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.97
91761043|NCT03058692|183413401|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
91761044|NCT03058692|183413402|OTHER|||||||0.15||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.15
91761045|NCT03058692|183413402|OTHER|||||||0.18||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.18
91761046|NCT03058692|183413403|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
91517814|NCT01106833|182910124|SUPERIORITY|||||||0.039||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.039
91761047|NCT03058692|183413403|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
91761048|NCT03058692|183413404|OTHER|||||||0.14||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.14
91761049|NCT03058692|183413404|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
91761050|NCT03058692|183413405|OTHER|||||||0.72||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.72
91761051|NCT03058692|183413405|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
91761052|NCT03058692|183413406|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
91535643|NCT02715258|182949835|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Analysis of change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
91535644|NCT02715258|182949835|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0021|TWO_SIDED|95.0|-0.68|-0.15||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.15|-0.68|0.0021
91535645|NCT02715258|182949835|SUPERIORITY||mixed-effects repeated measures|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication||-0.30|-0.80|<0.0001
91535646|NCT02715258|182949835|SUPERIORITY||mixed-effects repeated measures|-0.4||||0.0009|TWO_SIDED|95.0|-0.64|-0.17||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.17|-0.64|0.0009
91535647|NCT02715258|182949836|SUPERIORITY||mixed-effects repeated measures|-2.14||||0.234|TWO_SIDED|95.0|-5.66|1.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in SBP (mm Hg) at Week 24||1.39|-5.66|0.2340
91535648|NCT02715258|182949836|SUPERIORITY||mixed-effects repeated measures|-1.91||||0.2937|TWO_SIDED|95.0|-5.48|1.66||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication||1.66|-5.48|0.2937
91761053|NCT03058692|183413406|OTHER|||||||0.22||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.22
91761054|NCT03058692|183413407|OTHER|||||||0.16||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.16
91761055|NCT03058692|183413407|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
91761056|NCT03058692|183413408|OTHER|||||||0.67||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.67
91761057|NCT03058692|183413408|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
91761058|NCT03058692|183413409|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
91761059|NCT03058692|183413409|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
91761060|NCT03058692|183413410|OTHER|||||||0.0093||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0093
91761061|NCT03058692|183413410|OTHER|||||||0.51||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.51
91761062|NCT03058692|183413411|OTHER|||||||0.54||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.54
91761063|NCT03058692|183413411|OTHER|||||||0.43||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.43
91761064|NCT03058692|183413412|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
91761065|NCT03058692|183413412|OTHER|||||||0.014||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.014
91761066|NCT03058692|183413413|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
91761067|NCT03058692|183413413|OTHER|||||||0.96||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.96
91761068|NCT03058692|183413414|OTHER|||||||0.65||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.65
91761069|NCT03058692|183413414|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
91761070|NCT03058692|183413415|OTHER|||||||0.35||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.35
91761071|NCT03058692|183413415|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
91761072|NCT03058692|183413416|OTHER|||||||0.86||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.86
91761073|NCT03058692|183413416|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
91761074|NCT04255862|183413434|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|103.4|||||TWO_SIDED|90.0|86.4|123.8||||||||123.8|86.4|
91761075|NCT04255862|183413434|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|97.9|135.0||||||||135.0|97.9|
91761076|NCT04255862|183413435|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|102.8|||||TWO_SIDED|90.0|87.0|121.5||||||||121.5|87.0|
91761077|NCT04255862|183413435|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|113.4|||||TWO_SIDED|90.0|97.4|131.9||||||||131.9|97.4|
91761078|NCT04255862|183413436|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|104.0|||||TWO_SIDED|90.0|90.3|119.7||||||||119.7|90.3|
91761079|NCT04255862|183413436|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|114.3|||||TWO_SIDED|90.0|99.5|131.4||||||||131.4|99.5|
91761080|NCT00555880|183413464|SUPERIORITY_OR_OTHER_LEGACY||Sign Statistic|3.0||||0.146|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.1460
91761081|NCT00555880|183413465|SUPERIORITY_OR_OTHER_LEGACY||Sign statistic|2.5||||0.2266|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.2266
91761082|NCT00555880|183413466|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|97.9||||0.0418|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period and treatment as fixed effects, and subject within sequence as a random effect|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|Analysis of treatment difference||||0.0418
91761083|NCT00555880|183413467|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|91.1||||0.1928|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a one-way ANOVA model|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|||||0.1928
91761084|NCT00555880|183413468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9479|TWO_SIDED|||||The P-value is from a 2-sample t-test for difference in mean|t-test, 2 sided|||||||0.9479
91761085|NCT00555880|183413469|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-5.7||||0.059|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment||||0.0590
91761086|NCT00555880|183413470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Dizziness, Lightheadedness, and Feeling Faint-Analysis of treatment||||0.0633
91761087|NCT00555880|183413470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Problems with Vision-Analysis of treatment||||0.0191
91761088|NCT00555880|183413470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0727|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Weakness-Analysis of treatment||||0.0727
91761089|NCT00555880|183413470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Fatigue-Analysis of treatment||||0.2820
91535649|NCT02715258|182949836|SUPERIORITY||mixed-effects repeated measures|-1.72||||0.403|TWO_SIDED|95.0|-5.75|2.32||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication||2.32|-5.75|0.4030
91535650|NCT02715258|182949836|SUPERIORITY||mixed-effects repeated measures|-2.09||||0.216|TWO_SIDED|95.0|-5.41|1.23||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||||1.23|-5.41|0.2160
91535651|NCT02715258|182949837|SUPERIORITY||mixed-effects repeated measures|-0.79||||0.1222|TWO_SIDED|95.0|-1.8|0.21||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2||0.21|-1.80|0.1222
91535652|NCT02715258|182949837|SUPERIORITY||mixed-effects repeated measures|-0.65||||0.2014|TWO_SIDED|95.0|-1.65|0.35||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.35|-1.65|0.2014
91761090|NCT00555880|183413470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Trouble Concentrating-Analysis of treatment||||0.0880
91761091|NCT00555880|183413470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6439|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Head/Neck Discomfort-Analysis of treatment||||0.6439
91761092|NCT00555880|183413473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0378|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Final systolic pressure-Analysis of treatment||||0.0378
91761093|NCT00555880|183413473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED||||||ANOVA|||Final diastolic pressure-Analysis of treatment||||0.0108
91761094|NCT00555880|183413475|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|92.4||||0.0296|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment difference||||0.0296
91761095|NCT00555880|183413480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||Signed Rank Test|||Analysis of treatment||||0.0342
91761096|NCT03004911|183413489|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
91761097|NCT03004911|183413490|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.890
91761098|NCT03004911|183413491|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||||||0.747
91761099|NCT03004911|183413492|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91761100|NCT03004911|183413493|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
91761101|NCT02610777|183413520|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.464|TWO_SIDED|95.0|0.577|1.286||P-value is from an unstratified log-rank test.|Log Rank||Hazard Ratio (HR) was based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.286|0.577|0.464
91761102|NCT02610777|183413521|SUPERIORITY||Hazard Ratio (HR)|0.706|||=|0.092|TWO_SIDED|95.0|0.469|1.061||P-value comparing EFS between treatment groups was based on the unstratified log-rank test.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival (EFS)||1.061|0.469|=0.092
91761103|NCT02610777|183413524|SUPERIORITY||Hazard Ratio (HR)|0.562|||=|0.267|TWO_SIDED|95.0|0.2|1.579||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.579|0.200|=0.267
91761104|NCT02610777|183413525|SUPERIORITY||Absolute Rate Difference|9.61|||=|0.312|TWO_SIDED|95.0|-8.83|28.04||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.04|-8.83|=0.312
91761105|NCT02610777|183413526|SUPERIORITY||Absolute Rate Difference|5.63||||0.56|TWO_SIDED|95.0|-13.19|24.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||24.44|-13.19|0.560
91761106|NCT02610777|183413527|SUPERIORITY||Absolute Rate Difference|8.64|||=|0.343|TWO_SIDED|95.0|-9.09|26.38||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||26.38|-9.09|=0.343
91761107|NCT02610777|183413528|SUPERIORITY||Absolute Rate Difference|-18.82|||=|0.296|TWO_SIDED|95.0|-52.91|15.26||P-value is from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||15.26|-52.91|=0.296
91761108|NCT02610777|183413529|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.152|TWO_SIDED|95.0|-4.49|30.81||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.81|-4.49|=0.152
91761109|NCT02610777|183413530|SUPERIORITY||Absolute Rate Difference|10.53|||=|0.301|TWO_SIDED|95.0|-9.13|30.18||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.18|-9.13|=0.301
91761110|NCT02610777|183413531|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.254|TWO_SIDED|95.0|-9.12|35.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||35.44|-9.12|=0.254
91761111|NCT02610777|183413532|SUPERIORITY||Absolute Rate Difference|-4.71|||=|0.787|TWO_SIDED|95.0|-38.33|28.92||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.92|-38.33|=0.787
91761112|NCT02610777|183413533|SUPERIORITY||Hazard Ratio (HR)|0.789|||=|0.62|TWO_SIDED|95.0|0.308|2.02||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||2.020|0.308|=0.620
91761113|NCT02610777|183413534|SUPERIORITY||Hazard Ratio (HR)|0.719|||=|0.436|TWO_SIDED|95.0|0.313|1.653||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.653|0.313|=0.436
91761114|NCT02610777|183413535|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.565|TWO_SIDED|95.0|0.395|1.662||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.662|0.395|=0.565
91761115|NCT02610777|183413536|SUPERIORITY||Hazard Ratio (HR)|0.42|||=|0.383|TWO_SIDED|95.0|0.057|3.109||P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||3.109|0.057|=0.383
91761116|NCT02610777|183413537|SUPERIORITY||Hazard Ratio (HR)|1.206|||=|0.498|TWO_SIDED|95.0|0.699|2.081||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\>1 for the treatment indicates a shorter time to first CR, CRi or PR in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||2.081|0.699|=0.498
91761117|NCT02610777|183413538|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.888|TWO_SIDED|95.0|0.226|3.62||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||3.620|0.226|=0.888
91761118|NCT02610777|183413539|SUPERIORITY||Absolute Rate Difference|19.231|||=|0.162|TWO_SIDED|95.0|-6.925|45.386||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBCs-transfusion Independence||45.386|-6.925|=0.162
91761119|NCT02610777|183413539|SUPERIORITY||Absolute Rate Difference|20.0|||=|0.454|TWO_SIDED|95.0|-26.381|66.381||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||66.381|-26.381|=0.454
91761120|NCT02610777|183413541|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.266|TWO_SIDED|95.0|0.521|1.198||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to PD, Relapse, or Death in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||1.198|0.521|=0.266
91761121|NCT01724866|183413547|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.72||||0.296|TWO_SIDED|95.0|0.19|1.27|||Bootstrap method|||A 2-sided 95% confidence interval (CI) for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||1.27|0.19|0.296
91761122|NCT01724866|183413547|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.14||||0.002|TWO_SIDED|95.0|-0.28|0.64|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.64|-0.28|0.002
91761123|NCT01724866|183413547|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.56|-0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-values was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||-0.06|-0.56|<0.001
91761124|NCT01724866|183413548|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.38||||0.001|TWO_SIDED|95.0|0.06|0.74|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.74|0.06|0.001
91761125|NCT01724866|183413548|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.04|||<|0.001|TWO_SIDED|95.0|-0.16|0.24|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.24|-0.16|<0.001
91761126|NCT01724866|183413548|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.19|0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.06|-0.19|<0.001
91761127|NCT01724866|183413549|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.31||||0.002|TWO_SIDED|95.0|-0.07|0.72|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.72|-0.07|0.002
91513612|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|3.64|||<|0.001|TWO_SIDED|95.0|3.33|3.98|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||3.98|3.33|< 0.001
91761128|NCT01724866|183413549|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.27|0.3|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.30|-0.27|<0.001
91761129|NCT01724866|183413549|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.27|0.28|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.28|-0.27|<0.001
91761130|NCT01724866|183413550|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.94||||0.781|TWO_SIDED|95.0|-0.01|2.47|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||2.47|-0.01|0.781
91761131|NCT01724866|183413550|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|-0.17|0.38|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.38|-0.17|<0.001
91761132|NCT01724866|183413550|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.02|||<|0.001|TWO_SIDED|95.0|-0.23|0.22|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.22|-0.23|<0.001
91761133|NCT01724866|183413551|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|1.1|0.002
91761134|NCT01724866|183413551|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.711|TWO_SIDED|95.0|0.6|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.6|0.711
91761135|NCT01724866|183413551|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.028|TWO_SIDED|95.0|0.1|0.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||0.9|0.1|0.028
91761136|NCT01724866|183413552|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.672|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.672
91761137|NCT01724866|183413552|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.348|TWO_SIDED|95.0|0.5|1.3|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.3|0.5|0.348
91761138|NCT01724866|183413552|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.973|TWO_SIDED|95.0|0.4|2.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.9|0.4|0.973
91761139|NCT01724866|183413553|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.618|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.618
91761140|NCT01724866|183413553|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.661|TWO_SIDED|95.0|0.5|1.6|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.6|0.5|0.661
91761141|NCT01724866|183413553|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.754|TWO_SIDED|95.0|0.3|2.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.8|0.3|0.754
91761142|NCT01724866|183413554|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.7|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.7|1.1|0.009
91761143|NCT01724866|183413554|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.527|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|0.7|0.527
91761144|NCT01724866|183413554|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.815|TWO_SIDED|95.0|0.4|3.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||3.9|0.4|0.815
91761145|NCT01724866|183413555|SUPERIORITY|||||||0.008|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.008
91761146|NCT01724866|183413555|SUPERIORITY|||||||0.911|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.911
91761147|NCT01724866|183413555|SUPERIORITY|||||||0.002|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.002
91761148|NCT01724866|183413556|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
91761149|NCT01724866|183413556|SUPERIORITY|||||||0.633|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.633
91761150|NCT01724866|183413556|SUPERIORITY|||||||0.027|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.027
91535653|NCT02715258|182949837|SUPERIORITY||mixed-effects repeated measures|-0.91||||0.0638|TWO_SIDED|95.0|-1.88|0.05||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication||0.05|-1.88|0.0638
91535654|NCT02715258|182949837|SUPERIORITY||mixed-effects repeated measures|-0.69||||0.1456|TWO_SIDED|95.0|-1.63|0.24||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.24|-1.63|0.1456
91535655|NCT02715258|182949838|SUPERIORITY||mixed-effects repeated measures|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.92|-1.09||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks||-1.09|-1.92|<0.0001
91535656|NCT02715258|182949839|SUPERIORITY||mixed-effects repeated measures|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.79|-0.43||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 6||-0.43|-0.79|<0.0001
91535657|NCT02715258|182949839|SUPERIORITY||mixed-effects repeated measures|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.92|-0.5||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 12||-0.50|-0.92|<0.0001
91535658|NCT02715258|182949839|SUPERIORITY||mixed-effects repeated measures|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 18||-0.36|-0.78|<0.0001
91535659|NCT02715258|182949839|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
91535660|NCT02715258|182949839|SUPERIORITY||mixed-effects repeated measures|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) across 24 weeks||-0.39|-0.76|<0.0001
91761151|NCT01724866|183413557|SUPERIORITY|||||||0.015|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.015
91761152|NCT01724866|183413557|SUPERIORITY|||||||0.571|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.571
91535661|NCT02715258|182949840|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0006|TWO_SIDED|95.0|1.69|6.8||The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Model-Adjusted proportion of subjects with HbA1c \<7% across 24 weeks||6.80|1.69|0.0006
91535662|NCT01280591|182949851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.3|STANDARD_ERROR_OF_MEAN|13.17||0.0002|TWO_SIDED|95.0|-106.8|-33.7|||ANCOVA|||||-33.7|-106.8|0.0002
91535663|NCT01280591|182949852|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91535664|NCT01280591|182949853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|70.4|STANDARD_ERROR_OF_MEAN|12.85||0.0001|TWO_SIDED|95.0|28.1|112.7|||ANCOVA|||||112.7|28.1|0.0001
91535665|NCT01280591|182949854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|2.14||0.0007|TWO_SIDED|95.0|3.7|19.7|||ANCOVA|||||19.7|3.7|0.0007
91535666|NCT01280591|182949855|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91535667|NCT01280591|182949856|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Cochran-Mantel-Haenszel|||||||0.0027
91535668|NCT01280591|182949857|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Cochran-Mantel-Haenszel|||||||0.0321
91535669|NCT01280591|182949858|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
91535670|NCT01280591|182949859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91535671|NCT01280591|182949860|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
91535672|NCT01280591|182949861|SUPERIORITY_OR_OTHER|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
91535673|NCT01280591|182949862|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91535674|NCT01280591|182949863|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91535675|NCT01280591|182949864|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Cochran-Mantel-Haenszel|||||||0.0016
91535676|NCT01280591|182949865|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
91535677|NCT01280591|182949866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91535678|NCT01280591|182949867|SUPERIORITY_OR_OTHER|||||||0.0064|||||||ANCOVA|||||||0.0064
91535679|NCT01280591|182949868|SUPERIORITY_OR_OTHER|||||||0.0047|||||||Cochran-Mantel-Haenszel|||||||0.0047
91535680|NCT01280591|182949869|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Log Rank|||||||0.0053
91535681|NCT01280591|182949871|SUPERIORITY_OR_OTHER|||||||0.2734|||||||Cochran-Mantel-Haenszel|||||||0.2734
91761153|NCT01724866|183413557|SUPERIORITY|||||||0.066|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.066
91761154|NCT01724866|183413558|SUPERIORITY|||||||0.106|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.106
91761155|NCT01724866|183413558|SUPERIORITY|||||||0.156|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.156
91761156|NCT01724866|183413558|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
91535682|NCT02175212|182949933|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.88||||0.01|TWO_SIDED|95.0|1.12|3.15|||Regression, Cox|||||3.15|1.12|0.01
91535683|NCT02175212|182949934|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.31||||0.01|TWO_SIDED|95.0|1.23|3.85|||Regression, Cox|||||3.85|1.23|0.01
91535684|NCT02175212|182949935|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.48||||0.009|TWO_SIDED|95.0|1.31|4.68|||Regression, Cox|||||4.68|1.31|0.009
91535685|NCT02131324|182949962|EQUIVALENCE|Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||||0.086|||||||ANOVA|||Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||0.086
91535686|NCT00812877|182949973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.35||||0.046|TWO_SIDED|95.0|1.19|4.66||A clustered permutation test with 10,000 random permutations based on the log rank test statistic was used for the primary treatment comparison to account for censoring and to ensure proper test size given the number of practices.|Log Rank||A confirmatory analysis, adjusted for patient, dentist, and tooth characteristics, and follow-up time, was performed using marginal proportional hazards regression with robust standard error estimates accounting for clustering by practice.|||4.66|1.19|.046
91535687|NCT01664104|182950025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
91535688|NCT01664104|182950025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
91535689|NCT01664104|182950026|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
91535690|NCT01664104|182950026|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
91535691|NCT01664104|182950027|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 3.||||||<0.0001
91535692|NCT01664104|182950027|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
91535693|NCT01664104|182950047|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
91535694|NCT01664104|182950047|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
91535695|NCT01664104|182950048|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
91535696|NCT01664104|182950048|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
91535697|NCT01664104|182950049|SUPERIORITY_OR_OTHER|||||||0.6904|||||||t-test|P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.6904
91535698|NCT01664104|182950049|SUPERIORITY_OR_OTHER|||||||0.6032|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.6032
91535699|NCT01664104|182950049|SUPERIORITY_OR_OTHER|||||||0.6146|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.6146
91535700|NCT01664104|182950050|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.0018
91535701|NCT01664104|182950050|SUPERIORITY_OR_OTHER|||||||0.1617|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.1617
91535702|NCT01664104|182950050|SUPERIORITY_OR_OTHER|||||||0.1296|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.1296
91535703|NCT01664104|182950053|SUPERIORITY_OR_OTHER|||||||0.5332|||||||t-test|P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.5332
91535704|NCT01664104|182950054|SUPERIORITY_OR_OTHER|||||||0.6159|||||||t-test|P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.6159
91535705|NCT01664104|182950055|SUPERIORITY_OR_OTHER|||||||0.237|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.2370
91535706|NCT01664104|182950055|SUPERIORITY_OR_OTHER|||||||0.8033|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.||||||0.8033
91535707|NCT01664104|182950056|SUPERIORITY_OR_OTHER|||||||0.0306|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0306
91761157|NCT01724866|183413559|SUPERIORITY||Ratio|0.4|||||TWO_SIDED|95.0|0.25|0.8||||||||0.80|0.25|
91761158|NCT01724866|183413559|SUPERIORITY||Ratio|1.0|||||TWO_SIDED|95.0|0.53|2.04||||||||2.04|0.53|
91761159|NCT01724866|183413559|SUPERIORITY||Ratio|2.5|||||TWO_SIDED|95.0|1.4|4.54||||||||4.54|1.40|
91761160|NCT01724866|183413560|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.3|0.8||||||||0.80|0.30|
91761161|NCT01724866|183413560|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.7|1.79||||||||1.79|0.70|
91761162|NCT01724866|183413560|SUPERIORITY||Ratio|1.7|||||TWO_SIDED|95.0|1.07|2.79||||||||2.79|1.07|
91761163|NCT01724866|183413561|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.89||||||||0.89|0.34|
91761164|NCT01724866|183413561|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.71|1.85||||||||1.85|0.71|
91761165|NCT01724866|183413561|SUPERIORITY||Ratio|1.6|||||TWO_SIDED|95.0|0.97|2.49||||||||2.49|0.97|
91761166|NCT01724866|183413562|SUPERIORITY||Ratio|0.7|||||TWO_SIDED|95.0|0.4|1.1||||||||1.10|0.40|
91761167|NCT01724866|183413562|SUPERIORITY||Ratio|1.4|||||TWO_SIDED|95.0|0.87|2.38||||||||2.38|0.87|
91761168|NCT01724866|183413562|SUPERIORITY||Ratio|1.9|||||TWO_SIDED|95.0|1.23|2.96||||||||2.96|1.23|
91761169|NCT01724866|183413567|SUPERIORITY||Percent Difference|2.1||||1|TWO_SIDED|95.0|-20.2|24.9|||Fisher Exact|||||24.9|-20.2|1.000
91761170|NCT01724866|183413567|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
91761171|NCT01724866|183413567|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
91761172|NCT01724866|183413569|SUPERIORITY||Percent Difference|-6.2||||0.469|TWO_SIDED|95.0|-28.5|16.9|||Fisher Exact|||||16.9|-28.5|0.469
91761173|NCT01724866|183413569|SUPERIORITY||Percent Difference|-5.6||||0.71|TWO_SIDED|95.0|-29.3|18.7|||Fisher Exact|||||18.7|-29.3|0.710
91761174|NCT01724866|183413569|SUPERIORITY||Percent Difference|-11.1||||0.199|TWO_SIDED|95.0|-34.6|13.3|||Fisher Exact|||||13.3|-34.6|0.199
91761175|NCT01340586|183413579|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.787|||||TWO_SIDED|90.0|0.616|1.006||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.006|0.616|
91761176|NCT01340586|183413579|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.697|1.173||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.173|0.697|
91761177|NCT01340586|183413579|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.871|||||TWO_SIDED|90.0|0.723|1.049||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.049|0.723|
91535708|NCT01664104|182950056|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0749
91761178|NCT01340586|183413581|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.187|||||TWO_SIDED|90.0|0.907|1.553||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.553|0.907|
91761179|NCT01340586|183413581|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.389|||||TWO_SIDED|90.0|1.097|1.758||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.758|1.097|
91761180|NCT01340586|183413581|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.855|||||TWO_SIDED|90.0|0.707|1.033||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.033|0.707|
91761181|NCT01340586|183413583|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.165|||||TWO_SIDED|90.0|0.88|1.543||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.543|0.880|
91761182|NCT01340586|183413583|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.357|||||TWO_SIDED|90.0|1.066|1.728||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.728|1.066|
91761183|NCT01340586|183413583|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.858|||||TWO_SIDED|90.0|0.707|1.042||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.042|0.707|
91761184|NCT01173601|183413608|SUPERIORITY_OR_OTHER|||||||0.338||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.338
91761185|NCT01173601|183413608|SUPERIORITY_OR_OTHER|||||||0.201||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.201
91761186|NCT04737278|183413629|OTHER|test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91761187|NCT04737278|183413629|OTHER|||||||0.01|||||||t-test, 2 sided|||test of the hypothesis that the score on day 28 is different than the baseline score||||0.01
91761188|NCT04737278|183413630|OTHER|||||||0.15|||||||t-test, 2 sided|||Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p\<0.05. Within group comparisons were made using the paired Student's t test.||||0.15
91761189|NCT04737278|183413631|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91761190|NCT04737278|183413631|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||comparison made between placebo and Cunermuspir at baseline||||0.03
91761191|NCT04737278|183413631|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||comparison made at day 28||||0.01
91761192|NCT04737278|183413631|OTHER|||||||0.07|||||||t-test, 2 sided|||comparison between baseline and day 28||||0.07
91761193|NCT04737278|183413632|OTHER|||||||0.54|||||||Fisher Exact|||base line between group comparisons||||0.54
91761194|NCT04737278|183413632|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
91761195|NCT04737278|183413633|OTHER|||||||0.54|||||||ANCOVA|||||||0.54
91761196|NCT04737278|183413634|OTHER||||||<|0.01|||||||ANCOVA|||The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28||||<0.01
91761197|NCT04737278|183413635|OTHER|||||||0.31|||||||ANCOVA|||||||0.31
91761198|NCT04737278|183413636|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
91761199|NCT04737278|183413637|OTHER|||||||0.84|||||||ANCOVA|||||||0.84
91761200|NCT04737278|183413638|OTHER|||||||0.63|||||||ANCOVA|||||||0.63
91761201|NCT04737278|183413639|OTHER|||||||0.05|||||||ANCOVA|||||||0.05
91761202|NCT04737278|183413640|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91761203|NCT04737278|183413641|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91761204|NCT04737278|183413642|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
91761205|NCT04737278|183413643|OTHER|||||||0.06|||||||ANCOVA|||||||0.06
91761206|NCT04737278|183413644|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
91761207|NCT04737278|183413645|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
91761208|NCT04737278|183413645|OTHER|||||||0.05|||||||t-test, 2 sided|||comparison of neutrophils from baseline to day 28||||0.05
91761209|NCT04737278|183413646|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
91761210|NCT04737278|183413647|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||comparison of baseline values||||0.47
91761211|NCT04737278|183413647|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||comparison performed on data from day 28||||0.24
91761212|NCT04737278|183413648|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||comparison of eosinophil counts at day 28||||0.11
91761213|NCT04737278|183413649|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The day 28 basophil counts on day 28 were compared between the two arms of this study.||||0.98
91535709|NCT01664104|182950057|SUPERIORITY_OR_OTHER|||||||0.4854|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.4854
91535710|NCT01664104|182950057|SUPERIORITY_OR_OTHER|||||||0.325|||||||S|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.3250
91535711|NCT01664104|182950058|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0011
91535712|NCT01664104|182950058|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Spearman Correlation|P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0013
91535713|NCT01664104|182950059|SUPERIORITY_OR_OTHER|||||||0.5655|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.5655
91535714|NCT01664104|182950059|SUPERIORITY_OR_OTHER|||||||0.3977|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.3977
91535715|NCT01664104|182950060|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Pearson correlation|P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.||||||0.0123
91535716|NCT01664104|182950060|SUPERIORITY_OR_OTHER|||||||0.0151|||||||Spearman Correlation|P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6||||||0.0151
91535717|NCT01664104|182950061|SUPERIORITY_OR_OTHER|||||||0.9909|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.9909
91535718|NCT01664104|182950061|SUPERIORITY_OR_OTHER|||||||0.6482|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.6482
91535719|NCT04930822|182950062|SUPERIORITY||Predicted least squares mean difference|-5.107||||0.1779|TWO_SIDED|95.0|-12.6|2.385||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||2.385|-12.60|0.1779
91535720|NCT04930822|182950062|SUPERIORITY||Predicted least squares mean difference|-8.809||||0.0219|TWO_SIDED|95.0|-16.3|-1.317||Fisher's LSD utilized; no corrections for multiple comparisons|ANOVA|||Alpha set at 0.05||-1.317|-16.30|0.0219
91535721|NCT04930822|182950062|SUPERIORITY||Predicted least squares mean difference|-4.063||||0.0139|TWO_SIDED|95.0|-7.24|-0.8849||Fisher's LSD utilized; no corrections for multiple comparisons|ANOVA|||Alpha set at 0.05||-0.8849|-7.240|0.0139
91535722|NCT04930822|182950062|SUPERIORITY||Predicted least squares mean difference|-7.765|||<|0.0001|TWO_SIDED|95.0|-10.85|-4.682||Fisher's LSD utilized; no corrections for multiple comparisons|ANOVA|||Alpha set at 0.05||-4.682|-10.85|<0.0001
91535723|NCT04930822|182950063|SUPERIORITY||Predicted least squares mean difference|-7.883||||0.493|TWO_SIDED|95.0|-30.59|14.83||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||14.83|-30.59|0.4930
91535724|NCT04930822|182950063|SUPERIORITY||Predicted least squares mean difference|-13.97||||0.2255|TWO_SIDED|95.0|-36.68|8.744||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||8.744|-36.68|0.2255
91535725|NCT04930822|182950063|SUPERIORITY||Predicted least squares mean difference|-49.32|||<|0.0001|TWO_SIDED|95.0|-63.18|-35.46||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||-35.46|-63.18|<0.0001
91535726|NCT04930822|182950063|SUPERIORITY||Predicted least squares mean difference|-55.41|||<|0.0001|TWO_SIDED|95.0|-67.66|-43.16||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||-43.16|-67.66|<0.0001
91535727|NCT04930822|182950064|SUPERIORITY||Predicted least squares mean difference|-2.611||||0.49|TWO_SIDED|95.0|-10.13|4.909||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha is set at 0.05||4.909|-10.13|0.49
91535728|NCT04930822|182950064|SUPERIORITY||Predicted least squares mean difference|-4.634||||0.2246|TWO_SIDED|95.0|-12.15|2.886||Fisher's LSD utlilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||2.886|-12.15|0.2246
91535729|NCT04930822|182950064|SUPERIORITY||Predicted least squares mean difference|-16.32|||<|0.0001|TWO_SIDED|95.0|-20.91|-11.74||Fisher's LSD; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||-11.74|-20.91|<0.0001
91535730|NCT04930822|182950064|SUPERIORITY||Predicted least squares mean difference|-18.35|||<|0.0001|TWO_SIDED|95.0|-22.4|-14.29||Fisher's LSD utilized; no correction for multiple comparisons|ANOVA|||Alpha set at 0.05||-14.29|-22.40|<0.0001
91535731|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 1.|Student's t-test|||||||<0.0001
91535732|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 14.|Student's t-test|||||||<0.0001
91535733|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 31.|Student's t-test|||||||<0.0001
91535734|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 10.|Student's t-test|||||||<0.0001
91535735|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 18.|Student's t-test|||||||<0.0001
91535736|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 26.|Student's t-test|||||||<0.0001
91535737|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 34.|Student's t-test|||||||<0.0001
91535738|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 42.|Student's t-test|||||||<0.0001
91535739|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 50.|Student's t-test|||||||<0.0001
91535740|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 58.|Student's t-test|||||||<0.0001
91535741|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 70.|Student's t-test|||||||<0.0001
91535742|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 82.|Student's t-test|||||||<0.0001
91535743|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 94.|Student's t-test|||||||<0.0001
91761214|NCT04737278|183413650|OTHER|||||||0.025||||||This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.|ANOVA|||"All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php~Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:~http://vassarstats.net/anova2u.html"||||0.025
91535744|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 106.|Student's t-test|||||||<0.0001
91535745|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 118.|Student's t-test|||||||<0.0001
91535746|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 130.|Student's t-test|||||||<0.0001
91535747|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 142.|Student's t-test|||||||<0.0001
91535748|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 154.|Student's t-test|||||||<0.0001
91535749|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 166.|Student's t-test|||||||<0.0001
91535750|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 178.|Student's t-test|||||||<0.0001
91535751|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 190.|Student's t-test|||||||<0.0001
91535752|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 202.|Student's t-test|||||||<0.0001
91535753|NCT02449044|182950083|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 214.|Student's t-test|||||||<0.0001
91535754|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.4922
91535755|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.1054
91535756|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.7656|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.7656
91761215|NCT04737278|183413651|OTHER|||||||0.06|||||||t-test, 2 sided|||Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.||||0.06
91535757|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.7084|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.7084
91761216|NCT04737278|183413651|OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison of enrollment baseline blood glucose and day 28 in the placebo arm||||0.04
91535758|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.5138
91535759|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.7175|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.7175
91535760|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.3540
91535761|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.0852|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0852
91535762|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.1923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.1923
91535763|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.2335|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2335
91535764|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.1346|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.1346
91535765|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.5237|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.5237
91535766|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.3476|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 118||||0.3476
91535767|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.2488|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 130||||0.2488
91535768|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.1598|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.1598
91535769|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.282|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 154||||0.2820
91535770|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.3743|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.3743
91535771|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.3600
91761217|NCT04737278|183413651|OTHER|||||||0.92|||||||ANCOVA|||||||0.92
91761218|NCT04737278|183413652|OTHER|||||||0.51|||||||ANCOVA|||||||0.51
91761219|NCT04737278|183413653|OTHER|||||||0.38|||||||ANCOVA|||||||0.38
91761220|NCT04737278|183413654|OTHER|||||||0.01|||||||ANCOVA|||||||0.01
91761221|NCT04737278|183413655|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
91761222|NCT04737278|183413655|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
91761223|NCT04737278|183413655|OTHER|||||||0.01|||||||t-test, 2 sided|||Blood sodium concentration between baseline and day 28 in the Placebo group.||||0.01
91761224|NCT04737278|183413656|OTHER|||||||0.58|||||||ANCOVA|||||||0.58
91535772|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.3101|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3101
91535773|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 202||||0.0269
91535774|NCT02449044|182950090|SUPERIORITY_OR_OTHER|||||||0.0944|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.0944
91535775|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.1739
91535776|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.6095|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.6095
91535777|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.6902|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6902
91535778|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.634|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.6340
91535779|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.321|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.3210
91535780|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.7787|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.7787
91535781|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.2198|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.2198
91535782|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.1926|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.1926
91535783|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.3109|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.3109
91535784|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.2269
91535785|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2749
91535786|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.0702|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0702
91535787|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0412
91535788|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.4448|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.4448
91535789|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.6233|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6233
91535790|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.1001|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.1001
91535791|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.3739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3739
91535792|NCT02449044|182950091|SUPERIORITY_OR_OTHER|||||||0.3334|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3334
91535793|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.2575|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.2575
91535794|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.2715|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.2715
91535795|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.686|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6860
91535796|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0224|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.0224
91535797|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.1871|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.1871
91535798|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.0039
91535799|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0325|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.0325
91535800|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.0631
91535801|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0277|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0277
91535802|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0128|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.0128
91535803|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.0164
91535804|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0119
91535805|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0013
91517815|NCT01106833|182910124|SUPERIORITY|||||||0.278||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.278
91517816|NCT01106833|182910124|SUPERIORITY|||||||0.804||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.804
91517817|NCT01106833|182910125|SUPERIORITY|||||||0.631||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.631
91517818|NCT01106833|182910125|SUPERIORITY|||||||0.759||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.759
91517819|NCT01106833|182910125|SUPERIORITY|||||||0.391||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.391
91517820|NCT01106833|182910125|SUPERIORITY|||||||0.222||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.222
91761225|NCT04737278|183413656|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants||||<0.001
91535806|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.6691|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.6691
91535807|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.6923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6923
91535808|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.9292|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.9292
91535809|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.4401|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.4401
91535810|NCT02449044|182950092|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3609
91535811|NCT05298111|182950094|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91535812|NCT05298111|182950095|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||< 0.001
91535813|NCT05298111|182950096|SUPERIORITY||||||<|0.001|||||||Sign test|||||||< 0.001
91535814|NCT05298111|182950097|SUPERIORITY|||||||0.001|||||||Sign test|||||||0.001
91535815|NCT05298111|182950098|SUPERIORITY|||||||0.894|||||||Paired t-test|||||||0.894
91535816|NCT05298111|182950099|SUPERIORITY|||||||0.629|||||||Paired t-test|||||||0.629
91535817|NCT05298111|182950100|SUPERIORITY|||||||0.653|||||||Paired t-test|||||||0.653
91535818|NCT05298111|182950101|SUPERIORITY|||||||0.624|||||||Paired t-test|||||||0.624
91535819|NCT05298111|182950102|SUPERIORITY|||||||0.414|||||||Paired t-test|||||||0.414
91535820|NCT05298111|182950103|SUPERIORITY|||||||0.105|||||||Paired t-test|||||||0.105
91535821|NCT02628093|182950112|OTHER|Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.||||||0.214||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.||||0.214
91535822|NCT02628093|182950113|OTHER|||||||0.007||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||compared between groups by the Wilcoxon rank-sum test||||0.007
91535823|NCT02628093|182950117|OTHER|||||||1||||||P value threshold \<0.05|Fisher Exact|||||||1.0
91535824|NCT04310579|182950143|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.22|ONE_SIDED|95.0||2.5||To demonstrate an effect of oxycodone with midazolam compared to oxycodone alone, it is necessary that the upper bound of the one-sided 95% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone with midazolam compared to oxycodone alone.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||2.5||0.22
91535825|NCT04310579|182950144|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.01|ONE_SIDED|97.5||-0.6||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-0.6||0.01
91535826|NCT04310579|182950144|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.28|ONE_SIDED|97.5||2.8||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||2.8||0.28
91761226|NCT04737278|183413656|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.||||<0.001
91761227|NCT04737278|183413657|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
91761228|NCT04737278|183413657|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison between baseline and day 28 chloride concentrations in the Cunermuspir group||||0.003
91761229|NCT04737278|183413657|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants||||0.003
91761230|NCT04737278|183413658|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Bilirubin concentrations between Placebo and Cunermuspir compared at day 28||||0.36
91761231|NCT04737278|183413658|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-Rank||comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm||||0.72
91761232|NCT04737278|183413658|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm||||0.35
91761233|NCT04737278|183413659|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91761234|NCT04737278|183413659|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values in Cunermuspir group||||0.4
91761235|NCT04737278|183413659|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values for the Placebo Arm||||0.8
91761236|NCT04737278|183413660|OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo||||0.62
91761237|NCT04737278|183413660|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison||||0.24
91761238|NCT04737278|183413660|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison of AST activity in Placebo group||||0.11
91761239|NCT04737278|183413661|OTHER|||||||0.11||||||Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28|Wilcoxon (Mann-Whitney)|||comparison between placebo and Cunermuspir at day 28||||0.11
91761240|NCT04737278|183413661|OTHER|||||||0.01|||||||Wilcoxon Signed Rank|||Comparison of GGT activities in participants' blood at baseline and on day 28||||0.01
91761241|NCT04737278|183413661|OTHER|||||||0.97|||||||Wilcoxon Signed-Rank|||Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28||||0.97
91761242|NCT04737278|183413662|OTHER|||||||0.03|||||||ANCOVA|||Between group comparisons were made using ANCOVA||||0.03
91761243|NCT04737278|183413662|OTHER|||||||0.1|||||||t-test, 2 sided|||comparison of baseline with day 28||||0.10
91761244|NCT04737278|183413662|OTHER|||||||0.89|||||||t-test, 2 sided|||comparison between baseline and day 28 serum copper concentrations in the Placebo Arm||||0.89
91761245|NCT03671213|183413663|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Non-inferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \> 0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
91761246|NCT03223337|183413672|OTHER||Ratio of Geometric Least Square(LS) Mean|1.9973|||||TWO_SIDED|90.0|1.1063|3.6057|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6057|1.1063|
91761247|NCT03223337|183413672|OTHER||Ratio of Geometric LS Mean|1.6471|||||TWO_SIDED|90.0|1.1267|2.4079|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4079|1.1267|
91761248|NCT03223337|183413672|OTHER||Ratio of Geometric LS Mean|1.6404|||||TWO_SIDED|90.0|1.0744|2.5048|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5048|1.0744|
91761249|NCT03223337|183413672|OTHER||Ratio of Geometric LS Mean|1.4931|||||TWO_SIDED|90.0|1.0876|2.0498|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0498|1.0876|
91761250|NCT03223337|183413672|OTHER||Ratio of Geometric LS Mean|1.6222|||||TWO_SIDED|90.0|1.1594|2.2696|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2696|1.1594|
91761251|NCT03223337|183413672|OTHER||Ratio of Geometric LS Mean|1.3145|||||TWO_SIDED|90.0|0.9896|1.7462|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7462|0.9896|
91761252|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|1.4574|||||TWO_SIDED|90.0|1.035|2.0523|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0523|1.0350|
91761253|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|1.9375|||||TWO_SIDED|90.0|1.3919|2.6968|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.6968|1.3919|
91761254|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|1.8312|||||TWO_SIDED|90.0|1.3342|2.5133|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5133|1.3342|
91761255|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|2.003|||||TWO_SIDED|90.0|1.4654|2.7378|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7378|1.4654|
91761256|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|1.7113|||||TWO_SIDED|90.0|1.2818|2.2847|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2847|1.2818|
91761257|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|1.974|||||TWO_SIDED|90.0|1.5365|2.536|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5360|1.5365|
91761258|NCT03223337|183413673|OTHER||Ratio of Geometric LS Mean|1.4603|||||TWO_SIDED|90.0|0.9081|2.3484|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3484|0.9081|
91761259|NCT03223337|183413676|OTHER||Ratio of Geometric LS Mean|1.9973|||||TWO_SIDED|90.0|1.1061|3.6066|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6066|1.1061|
91761260|NCT03223337|183413676|OTHER||Ratio of Geometric LS Mean|1.6509|||||TWO_SIDED|90.0|1.1285|2.415|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4150|1.1285|
91761261|NCT03223337|183413676|OTHER||Ratio of Geometric LS Mean|1.6421|||||TWO_SIDED|90.0|1.0732|2.5125|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5125|1.0732|
91761262|NCT03223337|183413676|OTHER||Ratio of Geometric LS Mean|1.5169|||||TWO_SIDED|90.0|1.0994|2.093|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0930|1.0994|
91761263|NCT03223337|183413676|OTHER||Ratio of Geometric LS Mean|1.624|||||TWO_SIDED|90.0|1.1599|2.2736|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2736|1.1599|
91761264|NCT03223337|183413676|OTHER||Ratio of Geometric LS Mean|1.3143|||||TWO_SIDED|90.0|0.9887|1.747|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7470|0.9887|
91761265|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|1.4566|||||TWO_SIDED|90.0|1.0344|2.0513|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0513|1.0344|
91761266|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|1.9478|||||TWO_SIDED|90.0|1.3935|2.7224|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7224|1.3935|
91761267|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|1.8392|||||TWO_SIDED|90.0|1.335|2.534|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5340|1.3350|
91761268|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|2.0161|||||TWO_SIDED|90.0|1.4711|2.763|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7630|1.4711|
91761269|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|1.7303|||||TWO_SIDED|90.0|1.2932|2.3151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3151|1.2932|
91761270|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|1.987|||||TWO_SIDED|90.0|1.5426|2.5594|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5594|1.5426|
91761271|NCT03223337|183413677|OTHER||Ratio of Geometric LS Mean|1.4646|||||TWO_SIDED|90.0|0.9086|2.3609|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3609|0.9086|
91761272|NCT03223337|183413678|OTHER||Ratio of Geometric LS Mean|1.9786|||||TWO_SIDED|90.0|1.0557|3.7084|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.7084|1.0557|
91761273|NCT03223337|183413678|OTHER||Ratio of Geometric LS Mean|1.2791|||||TWO_SIDED|90.0|0.9241|1.7705|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7705|0.9241|
91761274|NCT03223337|183413678|OTHER||Ratio of Geometric LS Mean|1.2487|||||TWO_SIDED|90.0|0.8675|1.7974|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7974|0.8675|
91761275|NCT03223337|183413678|OTHER||Ratio of Geometric LS Mean|1.1802|||||TWO_SIDED|90.0|0.9165|1.5197|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5197|0.9165|
91761276|NCT03223337|183413678|OTHER||Ratio of Geometric LS Mean|1.2726|||||TWO_SIDED|90.0|0.952|1.7012|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7012|0.9520|
91761277|NCT03223337|183413678|OTHER||Ratio of Geometric LS Mean|1.0409|||||TWO_SIDED|90.0|0.7927|1.3668|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3668|0.7927|
91761278|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.0097|||||TWO_SIDED|90.0|0.7122|1.4316|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4316|0.7122|
91761279|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.7852|||||TWO_SIDED|90.0|1.2498|2.5498|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5498|1.2498|
91761280|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.7337|||||TWO_SIDED|90.0|1.2343|2.4353|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4353|1.2343|
91761281|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.7628|||||TWO_SIDED|90.0|1.2898|2.4092|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4092|1.2898|
91761282|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.6413|||||TWO_SIDED|90.0|1.2055|2.2347|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2347|1.2055|
91761283|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.8289|||||TWO_SIDED|90.0|1.3992|2.3904|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3904|1.3992|
91761284|NCT03223337|183413679|OTHER||Ratio of Geometric LS Mean|1.3367|||||TWO_SIDED|90.0|0.8288|2.1557|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.1557|0.8288|
91761285|NCT03223337|183413680|OTHER||Ratio of Geometric LS Mean|0.905|||||TWO_SIDED|90.0|0.69|1.1869|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.1869|0.6900|
91761286|NCT03223337|183413680|OTHER||Ratio of Geometric LS Mean|0.7415|||||TWO_SIDED|90.0|0.5617|0.9787|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.9787|0.5617|
91761287|NCT03223337|183413680|OTHER||Ratio of Geometric LS Mean|0.7299|||||TWO_SIDED|90.0|0.4387|1.2145|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2145|0.4387|
91761288|NCT03223337|183413680|OTHER||Ratio of Geometric LS Mean|1.1703|||||TWO_SIDED|90.0|0.9|1.5219|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5219|0.9000|
91761289|NCT03223337|183413680|OTHER||Ratio of Geometric LS Mean|0.9585|||||TWO_SIDED|90.0|0.6664|1.3786|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3786|0.6664|
91761290|NCT03223337|183413680|OTHER||Ratio of Geometric LS Mean|1.0004|||||TWO_SIDED|90.0|0.7833|1.2778|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2778|0.7833|
91761291|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.0574|||||TWO_SIDED|90.0|0.7876|1.4197|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4197|0.7876|
91761292|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.0143|||||TWO_SIDED|90.0|0.7332|1.4032|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4032|0.7332|
91761293|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.038|||||TWO_SIDED|90.0|0.7695|1.4002|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4002|0.7695|
91761294|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.3427|||||TWO_SIDED|90.0|0.7635|2.3615|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3615|0.7635|
91761295|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.0296|||||TWO_SIDED|90.0|0.6996|1.5151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5151|0.6996|
91761296|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.2721|||||TWO_SIDED|90.0|0.8409|1.9245|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.9245|0.8409|
91761297|NCT03223337|183413681|OTHER||Ratio of Geometric LS Mean|1.2072|||||TWO_SIDED|90.0|0.9398|1.5508|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5508|0.9398|
91761298|NCT03223337|183413682|OTHER||Median Difference (Final Values)|0.0||||0.6822|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6822
91761299|NCT03223337|183413682|OTHER||Median Difference (Final Values)|0.0||||0.5767|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5767
91761300|NCT03223337|183413682|OTHER||Median Difference (Final Values)|0.0||||0.588|TWO_SIDED|90.0|-1.0|1.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.50|-1.00|0.5880
91761301|NCT03223337|183413682|OTHER||Median Difference (Final Values)|0.0||||0.7716|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.7716
91761302|NCT03223337|183413682|OTHER||Median Difference (Final Values)|0.5||||0.4093|TWO_SIDED|90.0|-1.0|2.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.00|-1.00|0.4093
91761303|NCT03223337|183413682|OTHER||Median Difference (Final Values)|0.0||||0.9837|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.9837
91761304|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||0.6224|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6224
91761305|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|-1.0|0.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.00|-1.00|0.8042
91761306|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
91761307|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||0.5207|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5207
91761308|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
91761309|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|1.0000
91761310|NCT03223337|183413683|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|0.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|0.00|0.8042
91761311|NCT03688074|183413702|OTHER||Ratio of Geometric LSMeans|0.15|||<|0.001|TWO_SIDED|90.0|0.06|0.35||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter : Eosinophils (cells/mm\^2)||95% CI (0.05, 0.41)|0.35|0.06|<0.001
91761312|NCT03688074|183413702|OTHER||Ratio of Geometric LSMeans|1.36||||0.106|TWO_SIDED|90.0|0.99|1.86||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Neutrophils (cells/mm\^2)||95% CI (0.94, 1.97)|1.86|0.99|0.106
91761313|NCT03688074|183413702|OTHER||Ratio of Geometric LSMeans|1.12||||0.389|TWO_SIDED|90.0|0.9|1.4||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD3+ (cells/mm\^2)||95% CI (0.86, 1.46)|1.40|0.90|0.389
91761314|NCT03688074|183413702|OTHER||Ratio of Geometric LSMeans|1.18||||0.216|TWO_SIDED|90.0|0.94|1.48||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD4+ (cells/mm\^2)||95% CI (0.90, 1.55)|1.48|0.94|0.216
91761315|NCT03688074|183413702|OTHER||Ratio of Geometric LSMeans|0.83||||0.26|TWO_SIDED|90.0|0.64|1.09||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Tryptase+ (cells/mm\^2)||95% CI (0.61, 1.15)|1.09|0.64|0.260
91761316|NCT03688074|183413702|OTHER||Ratio of Geometric LSMeans|1.19||||0.546|TWO_SIDED|90.0|0.74|1.92||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Chymase+ (cells/mm\^2)||95% CI (0.67, 2.10)|1.92|0.74|0.546
91761317|NCT01362608|183413705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.0001|TWO_SIDED|95.0|-28.2|-11.2|||ANCOVA|||||-11.2|-28.2|<0.0001
91761318|NCT01362608|183413706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.0043|TWO_SIDED|95.0|0.1|0.71|||Regression, Cox|||||0.71|0.10|0.0043
91761319|NCT03928717|183413736|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91761320|NCT03928717|183413737|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91761321|NCT03350815|183413753|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.25||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of ASDAS inactive disease response by visit - in Treatment Period 2 (nonresponder imputation)||2.25|0.28|
91761322|NCT03350815|183413754|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|2.08|||||TWO_SIDED|95.0|0.5|8.66||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of reduction in ASDAS \>= 1.1 response by visit - in Treatment Period 2 (nonresponder imputation)||8.66|0.50|
91761323|NCT03350815|183413755|OTHER|Statistical hypothesis tests were not performed for this study|Least Square Mean of Treatment Differenc|0.23|STANDARD_ERROR_OF_MEAN|0.263|||TWO_SIDED|95.0|-0.29|0.75||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Mixed Models Analysis|||Statistical analysis of total BASDAI change from Week 16 using MMRM - in Treatment Period 2 (FAS)||0.75|-0.29|
91761324|NCT03350815|183413756|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.5|3.24||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI50 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.24|0.50|
91761325|NCT03350815|183413757|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.43|1.73||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI20 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||1.73|0.43|
91761326|NCT03350815|183413758|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.49|3.46||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS40 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.46|0.49|
91761327|NCT03350815|183413759|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.44|2.41||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status(naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS partial remission response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||2.41|0.44|
91761328|NCT03350815|183413760|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.74|1.01||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||Statistical analysis of change from Week 16 in ASAS-Health Index using MMRM by visit - in Treatment Period 2 (FAS)||1.01|-0.74|
91761329|NCT03350815|183413761|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.62|1.61||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||||1.61|-3.62|
91761330|NCT03526146|183413762|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
91761331|NCT03526146|183413763|SUPERIORITY|||||||0.047|||||||paired t-test|||||||0.047
91761332|NCT03526146|183413764|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
91761333|NCT03526146|183413765|SUPERIORITY|||||||0.05|||||||paired t-test|||||||0.05
91517821|NCT01106833|182910125|SUPERIORITY|||||||0.527||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.527
91761334|NCT03526146|183413766|SUPERIORITY|||||||0.009|||||||paired t-test|||||||0.009
91761335|NCT00536471|183413788|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||0.051
91761336|NCT00536471|183413788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||<0.001
91761337|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.013
91761338|NCT00536471|183413789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
91761339|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.026
91761340|NCT00536471|183413789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
91761341|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.202
91761342|NCT00536471|183413789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
91761343|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.027
91761344|NCT00536471|183413789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
91761345|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.076
91761346|NCT00536471|183413789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
91761347|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.149
91761348|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.062
91761349|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.629||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.629
91761350|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.194
91517822|NCT01106833|182910126|SUPERIORITY|||||||0.763||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.763
91761351|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.525
91761352|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.595
91761353|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.736
91761354|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.368
91761355|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.660
91761356|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.334
91761357|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.568
91761358|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.216
91761359|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.646
91517823|NCT01106833|182910126|SUPERIORITY|||||||0.133||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.133
91761360|NCT00536471|183413789|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.275
91761361|NCT00536471|183413790|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
91761362|NCT00536471|183413790|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline)|Mixed Models Analysis|||||||<0.001
91761363|NCT00536471|183413790|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.449
91761364|NCT00536471|183413790|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.167
91761365|NCT00536471|183413791|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.016
91761366|NCT00536471|183413791|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
91761367|NCT00536471|183413791|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.653
91761368|NCT00536471|183413791|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.417
91761369|NCT00536471|183413792|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.204
91761370|NCT00536471|183413792|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
91761371|NCT00536471|183413792|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
91761372|NCT00536471|183413792|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
91761373|NCT00536471|183413793|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.023
91761374|NCT00536471|183413793|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.100
91761375|NCT00536471|183413793|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
91761376|NCT00536471|183413793|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
91761377|NCT00536471|183413794|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.332
91761378|NCT00536471|183413794|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.041
91761379|NCT00536471|183413794|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.775
91761380|NCT00536471|183413794|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
91761381|NCT00536471|183413795|SUPERIORITY_OR_OTHER|||||||0.624||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.624
91761382|NCT00536471|183413795|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
91761383|NCT00536471|183413795|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.787
91761384|NCT00536471|183413795|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.086
91761385|NCT00536471|183413796|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.099
91761386|NCT00536471|183413796|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.223
91761387|NCT00536471|183413796|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
91761388|NCT00536471|183413796|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.233
91761389|NCT00536471|183413797|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.577
91761390|NCT00536471|183413797|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
91761391|NCT00536471|183413798|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.670
91761392|NCT00536471|183413798|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.059
91761393|NCT00536471|183413798|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.930
91761394|NCT00536471|183413798|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
91761395|NCT00536471|183413799|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.896
91761396|NCT00536471|183413799|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.796
91761397|NCT00536471|183413799|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
91761398|NCT00536471|183413799|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.381
91761399|NCT00536471|183413800|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.038
91761400|NCT00536471|183413800|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
91761401|NCT00536471|183413800|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.665
91761402|NCT00536471|183413800|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.253
91761403|NCT00536471|183413801|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
91761404|NCT00536471|183413801|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.312
91761405|NCT00536471|183413801|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
91761406|NCT00536471|183413801|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.913
91761407|NCT00536471|183413802|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
91761408|NCT00536471|183413802|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.216
91761409|NCT00536471|183413802|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
91761410|NCT00536471|183413802|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.908
91761411|NCT00536471|183413803|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
91761412|NCT00536471|183413803|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
91761413|NCT00536471|183413803|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.414
91761414|NCT00536471|183413803|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.717
91761415|NCT00536471|183413804|SUPERIORITY_OR_OTHER|||||||0.78||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.780
91761416|NCT00536471|183413804|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.152
91761417|NCT00536471|183413804|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.637
91761418|NCT00536471|183413804|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.024
91761419|NCT00536471|183413805|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.517
91761420|NCT00536471|183413805|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.256
91761421|NCT00536471|183413805|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
91761422|NCT00536471|183413805|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
91761423|NCT00536471|183413806|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.741
91761424|NCT00536471|183413806|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.722
91761425|NCT00536471|183413806|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
91761426|NCT00536471|183413806|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
91761427|NCT00536471|183413807|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
91761428|NCT00536471|183413807|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.949
91761429|NCT00536471|183413807|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
91761430|NCT00536471|183413807|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
91761431|NCT00536471|183413808|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.682
91761432|NCT00536471|183413808|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
91761433|NCT00536471|183413808|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.200
91761434|NCT00536471|183413808|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.813
91761435|NCT00536471|183413809|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.438
91761436|NCT00536471|183413809|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.018
91761437|NCT00536471|183413809|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
91761438|NCT00536471|183413809|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
91761439|NCT00536471|183413810|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
91761440|NCT00536471|183413810|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.758
91761441|NCT00536471|183413810|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
91761442|NCT00536471|183413810|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
91761443|NCT00536471|183413811|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.507
91761444|NCT00536471|183413811|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.466
91761445|NCT00536471|183413811|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
91761446|NCT00536471|183413811|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
91761447|NCT00536471|183413812|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.487
91761448|NCT00536471|183413812|SUPERIORITY_OR_OTHER|||||||0.678||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.678
91761449|NCT00536471|183413812|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
91761450|NCT00536471|183413812|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
91761451|NCT00536471|183413813|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
91761452|NCT00536471|183413813|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.135
91761453|NCT00536471|183413813|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
91761454|NCT00536471|183413813|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
91761455|NCT00536471|183413814|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
91761456|NCT00536471|183413814|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
91761457|NCT00536471|183413814|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
91761458|NCT00536471|183413814|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
91761459|NCT00536471|183413815|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.675
91761460|NCT00536471|183413815|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.139
91761461|NCT00536471|183413815|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
91761462|NCT00536471|183413815|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
91761463|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.007
91761464|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.031
91761465|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.020
91761466|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.324
91761467|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
91761468|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
91761469|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
91761470|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.019
91761471|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.201
91761472|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.069
91761473|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.368
91761474|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.435
91761475|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.090
91761476|NCT00536471|183413816|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.313
91761477|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.639
91761478|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.584
91761479|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.251||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.251
91761480|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.265
91761481|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
91761482|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.257
91761483|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.426
91761484|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
91761485|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.765
91761486|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.522
91761487|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.986
91761488|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.602
91761489|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.110
91761490|NCT00536471|183413817|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
91761491|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
91761492|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.065
91761493|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.229
91761494|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.044
91761495|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.092
91761496|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
91761497|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.142
91761498|NCT00536471|183413818|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
91761499|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.921
91761500|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.895
91761501|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
91761502|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.761||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.761
91761503|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.519
91761504|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.755||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.755
91761505|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.829||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.829
91761506|NCT00536471|183413819|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
91761507|NCT00536471|183413820|SUPERIORITY_OR_OTHER|||||||0.753||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.753
91761508|NCT00536471|183413820|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.036
91761509|NCT00536471|183413822|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.342
91761510|NCT00536471|183413822|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.111
91761511|NCT00536471|183413824|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.302
91761512|NCT00536471|183413824|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.029
91761513|NCT00536471|183413824|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.325
91761514|NCT00536471|183413824|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.423
91761515|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.731
91761516|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
91761517|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.948||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.948
91761518|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
91761519|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.950
91761520|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.442
91761521|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.218
91761522|NCT00536471|183413825|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.648
91761523|NCT00536471|183413826|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.653
91761524|NCT00536471|183413826|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.016
91761525|NCT00536471|183413826|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.665
91761526|NCT00536471|183413826|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.127
91761527|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.475
91761528|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.561
91761529|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.213||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.213
91761530|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.536
91761531|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.158
91761532|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.759
91761533|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.190
91761534|NCT00536471|183413827|SUPERIORITY_OR_OTHER|||||||0.852||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.852
91761535|NCT00536471|183413828|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.032
91761536|NCT00536471|183413828|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
91761537|NCT00536471|183413828|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.705
91761538|NCT00536471|183413828|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.388
91761539|NCT00536471|183413829|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.161
91761540|NCT00536471|183413829|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.198
91761541|NCT00536471|183413829|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.982
91761542|NCT00536471|183413829|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.407
91761543|NCT00536471|183413830|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
91761544|NCT00536471|183413830|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.006
91761545|NCT00536471|183413830|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.231
91761546|NCT00536471|183413830|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.040
91761547|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.914
91761548|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
91761549|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.296
91761550|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.034
91761551|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
91761552|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.614
91761553|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.146
91761554|NCT00536471|183413831|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.877
91761555|NCT00536471|183413832|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
91761556|NCT00536471|183413832|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.045
91761557|NCT00536471|183413832|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.701
91761558|NCT00536471|183413832|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.081
91761559|NCT00536471|183413833|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.013
91761560|NCT00536471|183413833|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.672
91761561|NCT00536471|183413833|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
91761562|NCT00536471|183413833|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.390
91761563|NCT00536471|183413838|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin - 12 Week Change.|ANOVA|||||||0.046
91761564|NCT00536471|183413838|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value for Creatinine - 12 Week Change.|ANOVA|||||||0.031
91761565|NCT00536471|183413838|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Uric Acid - 12 Week Change.|ANOVA|||||||0.003
91761566|NCT00536471|183413838|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value for Bilirubin - 9 Month Change.|ANOVA|||||||0.033
91761567|NCT00536471|183413838|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Uric Acid - 9 Month Change.|ANOVA|||||||0.013
91761568|NCT00536471|183413839|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Hematocrit - 12 Week Change.|ANOVA|||||||0.037
91761569|NCT00536471|183413839|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Hematocrit - 9 Month Change.|ANOVA|||||||0.029
91761570|NCT00536471|183413840|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for MCV - 12 Week Change.|ANOVA|||||||0.013
91761571|NCT00536471|183413840|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for MCV - 9 Month Change.|ANOVA|||||||0.014
91761572|NCT00536471|183413841|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Chloride - 12 Week Change.|ANOVA|||||||0.022
91761573|NCT00536471|183413841|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for Urea Nitrogen - 12 Week Change.|ANOVA|||||||0.044
91761574|NCT00536471|183413841|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Chloride - 9 Month Change.|ANOVA|||||||0.004
91761575|NCT00536471|183413841|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for Cholesterol - 9 Month Change.|ANOVA|||||||0.045
91761576|NCT00536471|183413841|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Sodium - 9 Month Change.|ANOVA|||||||0.043
91761577|NCT00536471|183413842|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for 12 Week Change.|ANOVA|||||||0.017
91761578|NCT00536471|183413842|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for 9 Month Change.|ANOVA|||||||0.003
91761579|NCT00536471|183413843|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
91761580|NCT00536471|183413844|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
91761581|NCT00536471|183413845|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.041
91517824|NCT01106833|182910126|SUPERIORITY|||||||0.953||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.953
91761582|NCT00536471|183413845|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.048
91761583|NCT00536471|183413846|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
91761584|NCT00536471|183413846|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.049
91761585|NCT00536471|183413847|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
91761586|NCT00536471|183413847|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Hemoglobin - Low.|Fisher Exact|||||||0.038
91761587|NCT01979952|183413883|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.176|STANDARD_ERROR_OF_MEAN|6.237|||TWO_SIDED|95.0|-9.227|15.579|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.579|-9.227|
91761588|NCT01979952|183413884|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.519|STANDARD_ERROR_OF_MEAN|6.3829|||TWO_SIDED|95.0|-10.258|15.296|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.296|-10.258|
91761589|NCT01979952|183413885|SUPERIORITY_OR_OTHER||Adjusted mean difference|69.0|STANDARD_ERROR_OF_MEAN|39.182|||TWO_SIDED|95.0|-8.74|146.75|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||146.75|-8.74|
91761590|NCT01979952|183413886|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.36|||||TWO_SIDED|95.0|-0.29|5.0|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||MMRM model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||5.00|-0.29|
91761591|NCT01979952|183413888|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|95.0|-4.89|4.79|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||4.79|-4.89|
91761592|NCT01979952|183413889|SUPERIORITY_OR_OTHER||Adjusted mean difference|17.94|STANDARD_ERROR_OF_MEAN|16.19|||TWO_SIDED|95.0|-14.21|50.09|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||50.09|-14.21|
91761593|NCT01979952|183413890|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89|||||TWO_SIDED|95.0|-1.47|11.25|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||11.25|-1.47|
91761594|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.053||||0.04|TWO_SIDED|95.0|0.003|0.104||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.104|0.003|0.040
91761595|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.103|||<|0.001|TWO_SIDED|95.0|0.052|0.153|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.153|0.052|<0.001
91761596|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.192|||<|0.001|TWO_SIDED|95.0|0.141|0.243||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.243|0.141|<0.001
91761597|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.173|||<|0.001|TWO_SIDED|95.0|0.123|0.224|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.224|0.123|<0.001
91761598|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.17|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.170|0.070|<0.001
91761599|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.14||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.140|0.039|<0.001
91761600|NCT01053988|183413909|SUPERIORITY_OR_OTHER||Least squares mean difference|0.071||||0.006|TWO_SIDED|95.0|0.021|0.121||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.021|0.006
91761601|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.033||||0.241|TWO_SIDED|95.0|-0.022|0.088|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.088|-0.022|0.241
91761602|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.067||||0.017|TWO_SIDED|95.0|0.012|0.121|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.012|0.017
91761603|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.129|||<|0.001|TWO_SIDED|95.0|0.074|0.184||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.184|0.074|<0.001
91761604|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.169|0.060|<0.001
91761605|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.136|0.028|0.003
91761606|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.062||||0.025|TWO_SIDED|95.0|0.008|0.117||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.117|0.008|0.025
91761607|NCT01053988|183413910|SUPERIORITY_OR_OTHER||Least squares mean difference|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.102|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.102|-0.006|0.082
91761608|NCT00719355|183413923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|STANDARD_DEVIATION|14.4||0.033|TWO_SIDED|95.0||||A priori level of significance was set at p \<0.05.|ANCOVA|Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.||Observed power for our primary analysis was 0.64.||||0.033
91761609|NCT00719355|183413924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.65||0.109||95.0|||||ANCOVA|Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.||||||0.109
91761610|NCT04260347|183413939|OTHER||Risk Ratio (RR)|1.064||||1|TWO_SIDED|95.0|0.345|1.784|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.784|0.345|1.000
91761611|NCT04260347|183413940|OTHER||Risk Ratio (RR)|0.889||||0.254|TWO_SIDED|95.0|0.699|1.08|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.08|0.699|0.254
91761612|NCT04260347|183413941|OTHER||Risk Ratio (RR)|1.089||||0.28|TWO_SIDED|95.0|0.942|1.237|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.237|0.942|0.280
91761613|NCT04260347|183413942|OTHER||Standardized Mean Difference (SMD)|0.016||||0.916|TWO_SIDED|95.0|-0.096|0.128|||Wilcoxon (Mann-Whitney)||SMD = Difference in the mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.128|-0.096|0.916
91761614|NCT04260347|183413943|OTHER||Risk Ratio (RR)|1.066||||0.561|TWO_SIDED|95.0|0.872|1.261|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.261|0.872|0.561
91761615|NCT04260347|183413944|OTHER||Risk Ratio (RR)|1.231||||0.522|TWO_SIDED|95.0|0.707|1.756|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.756|0.707|0.522
91761616|NCT04260347|183413945|OTHER||Standardized Mean Difference (SMD)|-0.021||||0.81|TWO_SIDED|95.0|-0.133|0.091|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.091|-0.133|0.810
91761617|NCT04260347|183413946|OTHER||Standardized Mean Difference (SMD)|-0.085||||0.179|TWO_SIDED|95.0|-0.199|0.03|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.03|-0.199|0.179
91761618|NCT04260347|183413947|OTHER||Standardized Mean Difference (SMD)|0.042||||0.275|TWO_SIDED|95.0|-0.072|0.156|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.156|-0.072|0.275
91761619|NCT02828020|183414130|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0023|TWO_SIDED|95.0|1.25|2.66||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.66|1.25|0.0023
91761620|NCT02828020|183414130|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0003|TWO_SIDED|95.0|1.41|2.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.95|1.41|0.0003
91761621|NCT02828020|183414131|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0023|TWO_SIDED|95.0|1.27|2.28||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.28|1.27|0.0023
91761622|NCT02828020|183414131|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0023|TWO_SIDED|95.0|1.22|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.17|1.22|0.0023
91761623|NCT02828020|183414132|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.23||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.23|1.28|0.0023
91761624|NCT02828020|183414132|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.21||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.21|1.28|0.0023
91761625|NCT02828020|183414133|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0023|TWO_SIDED|95.0|1.65|3.07||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.07|1.65|0.0023
91761626|NCT02828020|183414133|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0023|TWO_SIDED|95.0|1.77|3.24||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.24|1.77|0.0023
91761627|NCT02828020|183414134|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0577|TWO_SIDED|95.0|1.01|2.44||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.44|1.01|0.0577
91761628|NCT02828020|183414134|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0037|TWO_SIDED|95.0|1.28|2.97||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.97|1.28|0.0037
91761629|NCT02828020|183414135|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0577|TWO_SIDED|95.0|1.22|2.19||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.19|1.22|0.0577
91761630|NCT02828020|183414135|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0037|TWO_SIDED|95.0|1.36|2.42||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.42|1.36|0.0037
91761631|NCT02828020|183414136|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0577|TWO_SIDED|95.0|1.16|2.09||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||2.09|1.16|0.0577
91761632|NCT02828020|183414136|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0577|TWO_SIDED|95.0|1.1|1.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.95|1.10|0.0577
91761633|NCT02828020|183414137|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0962|TWO_SIDED|95.0|0.96|1.79||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.79|0.96|0.0962
91761634|NCT02828020|183414137|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0962|TWO_SIDED|95.0|1.0|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.83|1.00|0.0962
91761635|NCT02578186|183414144|SUPERIORITY_OR_OTHER|||||||0.0312|||||||ANCOVA|||||||0.0312
91761636|NCT02713659|183414161|EQUIVALENCE|0.05||||||0.85|||||||t-test, 2 sided|||Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.85
91761637|NCT02713659|183414161|EQUIVALENCE|0.05||||||0.53|||||||t-test, 2 sided|||Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.53
91761638|NCT02713659|183414161|EQUIVALENCE|0.05||||||0.49|||||||t-test, 2 sided|||Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.49
91761639|NCT02713659|183414162|EQUIVALENCE|0.05||||||0.57|||||||t-test, 2 sided|||Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy arm||||0.57
91761640|NCT02713659|183414163|EQUIVALENCE|0.05||||||0.23|||||||Chi-squared|||Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of age||||0.23
91761641|NCT02713659|183414163|EQUIVALENCE|0.05||||||0.71|||||||Chi-squared|||Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of age||||0.71
91761642|NCT02714283|183414219|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.19|TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use.|ICS (numerator) compared to macrolide monotherapy (denominator)|Due to the small sample size in the macrolide monotherapy group, for this outcome, the results are considered exploratory/descriptive only.||1.14|0.51|0.19
91761643|NCT02714283|183414220|SUPERIORITY||Hazard Ratio (HR)|1.39|||<|0.0001|TWO_SIDED|95.0|1.23|1.57|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.57|1.23|<0.0001
91761644|NCT02714283|183414221|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.21|TWO_SIDED|95.0|0.67|1.09|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.09|0.67|0.21
91761645|NCT02714283|183414222|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.82|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||0.82|0.64|<0.0001
91761646|NCT02714283|183414223|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.32|0.80|0.87
91761647|NCT02714283|183414224|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.23|TWO_SIDED|95.0|0.76|1.07|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.07|0.76|0.23
91761648|NCT02714283|183414225|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.2|TWO_SIDED|95.0|0.96|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|0.96|0.20
91761649|NCT02714283|183414226|SUPERIORITY||Hazard Ratio (HR)|1.15|||<|0.0001|TWO_SIDED|95.0|1.08|1.21|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.21|1.08|<0.0001
91761650|NCT02714283|183414227|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.66|1.51|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.51|0.66|0.99
91761651|NCT02714283|183414228|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.0005|TWO_SIDED|95.0|1.07|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|1.07|0.0005
91761652|NCT02964767|183414232|OTHER||||||<|0.049|||||||t-test, 2 sided|||||||<0.049
91761653|NCT03777059|183414233|SUPERIORITY||Least Squares Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.291|<|0.0001|TWO_SIDED|95.0|-1.78|-0.64||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.64|-1.78|<.0001
91761654|NCT03777059|183414233|SUPERIORITY||Least Squares Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.287|<|0.0001|TWO_SIDED|95.0|-1.94|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.94|<.0001
91761655|NCT03777059|183414233|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.288|<|0.0001|TWO_SIDED|95.0|-2.28|-1.15||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.15|-2.28|<.0001
91761656|NCT03777059|183414234|SUPERIORITY||Least Squares Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-2.03|-0.81||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.81|-2.03|<.0001
91761657|NCT03777059|183414234|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.92|-2.13|<.0001
91761658|NCT03777059|183414234|SUPERIORITY||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.309|<|0.0001|TWO_SIDED|95.0|-2.32|-1.1||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.10|-2.32|<.0001
91761659|NCT03777059|183414235|SUPERIORITY||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-1.81|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.81|<.0001
91761660|NCT03777059|183414235|SUPERIORITY||Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-1.82|-0.83||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.83|-1.82|<.0001
91761661|NCT03777059|183414235|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|-2.0|-1.01||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.01|-2.00|<.0001
91761662|NCT03777059|183414236|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|2.05|4.56||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||4.56|2.05|<.0001
91761663|NCT03777059|183414236|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.37|5.26||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.26|2.37|<.0001
91761664|NCT03777059|183414236|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.56|5.71||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.71|2.56|<.0001
91761665|NCT03777059|183414237|SUPERIORITY||Least Squares Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|95.0|5.45|14.36||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.36|5.45|<.0001
91761666|NCT03777059|183414237|SUPERIORITY||Least Squares Mean Difference|10.08|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|5.71|14.46||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.46|5.71|<.0001
91761667|NCT03777059|183414237|SUPERIORITY||Least Squares Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|2.231|<|0.0001|TWO_SIDED|95.0|6.42|15.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||15.18|6.42|<.0001
91761668|NCT03777059|183414238|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.693||0.0856|TWO_SIDED|95.0|-2.56|0.17||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.17|-2.56|0.0856
91761669|NCT03777059|183414238|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.694||0.0003|TWO_SIDED|95.0|-3.91|-1.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.18|-3.91|0.0003
91761670|NCT03777059|183414238|SUPERIORITY||Least Squares Mean Difference|-3.32|STANDARD_ERROR_OF_MEAN|0.694|<|0.0001|TWO_SIDED|95.0|-4.68|-1.96||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.96|-4.68|<.0001
91761671|NCT03777059|183414239|SUPERIORITY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.605||0.0743|TWO_SIDED|95.0|-2.27|0.11||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.11|-2.27|0.0743
91761672|NCT03777059|183414239|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.606||0.0011|TWO_SIDED|95.0|-3.18|-0.8||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.80|-3.18|0.0011
91761673|NCT03777059|183414239|SUPERIORITY||Least Squares Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|0.605|<|0.0001|TWO_SIDED|95.0|-3.65|-1.28||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.28|-3.65|<.0001
91761674|NCT01449006|183414256|SUPERIORITY_OR_OTHER|||||||0.05||||||This pilot study was conducted to generate effect sizes for a potential larger investigation. The study design and small sample size had limited power to detect a statistically significant effect at p\<0.05, so no p-value threshold was strictly set.|Mixed Models Analysis|41 data points included (control n=14; maraviroc: n=27); n=1 control did not attend 12-month visit.||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.05
91761675|NCT01449006|183414256|SUPERIORITY_OR_OTHER||Cohen's d|0.77|||||TWO_SIDED|90.0|-0.19|1.71|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 6-months was assessed by generating Cohen's d statistic and 90% confidence interval (CI) around the estimate.||1.71|-0.19|
91761676|NCT01449006|183414256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|90.0|-0.47|1.55|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 12-months was assessed by generating Cohen's d statistic and 90%CI around the estimate.||1.55|-0.47|
91761677|NCT01449006|183414257|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||Change in CSF neopterin levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.82
91761678|NCT01449006|183414258|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.49
91761679|NCT01449006|183414258|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.94
91761680|NCT01449006|183414258|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.80
91761681|NCT01449006|183414258|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.72
91761682|NCT01449006|183414259|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
91761683|NCT01449006|183414259|SUPERIORITY_OR_OTHER|||||||0.66|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.66
91761684|NCT01449006|183414259|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.56
91761685|NCT01449006|183414259|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.29
91761686|NCT01449006|183414259|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
91761687|NCT02214290|183414260|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
91761688|NCT02214290|183414261|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
91761689|NCT02214290|183414262|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
91761690|NCT03369249|183414306|SUPERIORITY||log ratio of rate ratios|0.15|STANDARD_ERROR_OF_MEAN|0.31||0.635|TWO_SIDED|95.0|-0.46|0.75||A priori threshold for statistical significance was \<0.05|generalized estimating equations||Standard error of the Beta regression coefficient.|||0.75|-0.46|0.635
91761691|NCT04112303|183414321|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified efficacy threshold of 78% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
91761692|NCT03781414|183414360|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.0759|||||TWO_SIDED|95.0|-0.0729|0.2165||||||||0.2165|-0.0729|
91761693|NCT03781414|183414360|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.1696|||||TWO_SIDED|95.0|0.0072|0.3276||||||||0.3276|0.0072|
91761694|NCT02161757|183414384|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.93||||0.5859|TWO_SIDED|95.0|0.72|1.21|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.||1.21|0.72|0.5859
91535827|NCT04310579|182950145|SUPERIORITY||Mean Difference (Final Values)|-10.2|||<|0.001|ONE_SIDED|97.5||-6.3||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.3||<0.001
91535828|NCT04310579|182950145|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.37|ONE_SIDED|97.5||3.2||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||3.2||0.37
91535829|NCT04310579|182950146|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.005|ONE_SIDED|95.0||-2.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||-2.5||0.005
91535830|NCT04310579|182950146|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.37|ONE_SIDED|95.0||3.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of midazolam compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of midazolam compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||3.7||0.37
91535831|NCT04310579|182950147|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|ONE_SIDED|97.5||-3.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.9||<0.001
91535832|NCT04310579|182950147|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.67|ONE_SIDED|97.5||6.4||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of quetiapine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of quetiapine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||6.4||0.67
91761695|NCT02161757|183414384|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.9||||0.4406|TWO_SIDED|95.0|0.7|1.17|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.||1.17|0.70|0.4406
91761696|NCT02161757|183414384|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|7.01||||0.5859|TWO_SIDED|95.0|-20.76|28.39|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.||28.39|-20.76|0.5859
91761697|NCT02161757|183414384|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|9.76||||0.4406|TWO_SIDED|95.0|-17.16|30.5|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.||30.50|-17.16|0.4406
91761698|NCT02161757|183414385|SUPERIORITY||Least square (LS) Mean difference|6.03|||||TWO_SIDED|95.0|2.34|9.73|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||9.73|2.34|
91761699|NCT02161757|183414385|SUPERIORITY||LS Mean difference|2.1|||||TWO_SIDED|95.0|-1.58|5.77|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||5.77|-1.58|
91761700|NCT02161757|183414386|SUPERIORITY||LS Mean difference|-0.09|||||TWO_SIDED|95.0|-0.23|0.04|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.04|-0.23|
91761701|NCT02161757|183414386|SUPERIORITY||LS Mean difference|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.12|-0.15|
91761702|NCT02161757|183414387|SUPERIORITY||LS Mean difference|0.15|||||TWO_SIDED|95.0|-0.01|0.31|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.31|-0.01|
91761703|NCT02161757|183414387|SUPERIORITY||LS Mean difference|0.12|||||TWO_SIDED|95.0|-0.03|0.28|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.28|-0.03|
91761704|NCT02161757|183414388|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.29|-0.02|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||-0.02|-0.29|
91761705|NCT02161757|183414388|SUPERIORITY||LS Mean difference|-0.12|||||TWO_SIDED|95.0|-0.26|0.01|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.01|-0.26|
91761706|NCT02161757|183414389|SUPERIORITY||Rate ratio|0.54||||0.0369|TWO_SIDED|95.0|0.3|0.96|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.||0.96|0.30|0.0369
91761707|NCT02161757|183414389|SUPERIORITY||Rate ratio|0.78||||0.3603|TWO_SIDED|95.0|0.46|1.33|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.||1.33|0.46|0.3603
91761708|NCT02161757|183414391|SUPERIORITY||LS Mean difference|-0.11|||||TWO_SIDED|95.0|-0.51|0.29|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.51|
91761709|NCT02161757|183414391|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.56|0.24|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.||0.24|-0.56|
91761710|NCT02161757|183414392|SUPERIORITY||LS Mean difference|6.25|||||TWO_SIDED|95.0|-3.53|16.03|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.03|-3.53|
91761711|NCT02161757|183414392|SUPERIORITY||LS Mean difference|1.77|||||TWO_SIDED|95.0|-7.99|11.53|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||11.53|-7.99|
91761712|NCT02161757|183414392|SUPERIORITY||LS Mean difference|7.14|||||TWO_SIDED|95.0|-2.6|16.87|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.87|-2.60|
91761713|NCT02161757|183414392|SUPERIORITY||LS Mean difference|0.61|||||TWO_SIDED|95.0|-9.13|10.35|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||10.35|-9.13|
91761714|NCT02161757|183414393|SUPERIORITY||LS Mean difference|-1.8|||||TWO_SIDED|95.0|-5.29|1.69|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||1.69|-5.29|
91761715|NCT02161757|183414393|SUPERIORITY||LS Mean difference|-2.36|||||TWO_SIDED|95.0|-5.84|1.12|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||1.12|-5.84|
91761716|NCT02161757|183414394|SUPERIORITY||Odds Ratio (OR)|0.95||||0.732|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.||1.28|0.71|0.732
91761717|NCT02161757|183414394|SUPERIORITY||Odds Ratio (OR)|0.88||||0.421|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.||1.19|0.65|0.421
91761718|NCT02106403|183414421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.46||||0.0659|TWO_SIDED|95.0|-0.37|11.29|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||11.29|-0.37|0.0659
91761719|NCT02106403|183414421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.99||||0.0928|TWO_SIDED|95.0|-0.84|10.81|||ANCOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.81|-0.84|0.0928
91761720|NCT02106403|183414421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.8711|TWO_SIDED|95.0|-5.35|6.31|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||6.31|-5.35|0.8711
91535833|NCT04310579|182950149|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.33|TWO_SIDED|90.0|0.96|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.96|0.33
91535834|NCT04310579|182950149|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.25|||<|0.001|TWO_SIDED|90.0|1.14|1.37||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.37|1.14|<0.001
91535835|NCT04310579|182950150|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.3|||<|0.001|TWO_SIDED|90.0|1.19|1.43||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.43|1.19|<0.001
91535836|NCT04310579|182950150|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.39|||<|0.001|TWO_SIDED|90.0|1.22|1.57||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.57|1.22|<0.001
91535837|NCT04310579|182950152|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.03||||0.64|TWO_SIDED|90.0|0.91|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.91|0.64
91535838|NCT04310579|182950152|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.24|TWO_SIDED|90.0|0.98|1.15||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.15|0.98|0.24
91535839|NCT04310579|182950153|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.1||||0.05|TWO_SIDED|90.0|1.02|1.19||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.19|1.02|0.05
91535840|NCT04310579|182950153|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.27|||<|0.001|TWO_SIDED|90.0|1.19|1.36||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.36|1.19|<0.001
91535841|NCT00315120|182950210|SUPERIORITY_OR_OTHER||Response ratio|2.0||||0.007|TWO_SIDED|95.0|1.2|3.2|||Chi-squared|||||3.2|1.2|0.007
91535842|NCT00315120|182950215|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared|||||1.7|0.7|0.72
91535843|NCT05419557|182950268|SUPERIORITY||Odds Ratio (OR)|8.5||||0.02|TWO_SIDED|95.0|1.3|54.6|||Regression, Logistic|||||54.6|1.3|0.02
91535844|NCT05419557|182950269|SUPERIORITY||Odds Ratio (OR)|9.98||||0.015|TWO_SIDED|95.0|1.55|64.25|||Regression, Logistic|||||64.25|1.55|0.015
91535845|NCT02281318|182950272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||<|0.001|TWO_SIDED|95.0|-10.5|-4.9|||Mixed model repeated measures analysis|||||-4.9|-10.5|<0.001
91535846|NCT02281318|182950273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0||||0.001|TWO_SIDED|95.0|47.0|192.0|||Mixed model repeated measures analysis|||||192|47|0.001
91535847|NCT02281318|182950274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.55|3.22|||Regression, Logistic|||||3.22|1.55|<0.001
91535848|NCT02281318|182950275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||Mixed model repeated measures analysis|||||-0.22|-0.58|<0.001
91761721|NCT02106403|183414422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.43||||0.0016|TWO_SIDED|95.0|4.43|18.42|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.42|4.43|0.0016
91761722|NCT02106403|183414422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.69||||0.6323|TWO_SIDED|95.0|-5.31|8.69|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.69|-5.31|0.6323
91761723|NCT02106403|183414422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.73||||0.0069|TWO_SIDED|95.0|2.74|16.73|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||16.73|2.74|0.0069
91535849|NCT03102710|182950324|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for lidocaine before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2.|Mean Difference (Final Values)|0.4||||0.03|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 0.4, between cathodal vs. sham was 1.2, and between anodal vs. cathodal was -0.8.|To assess the modulation effects of tDCS on placebo, we first performed an analysis of covariance (ANCOVA) with placebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.03
91535850|NCT03102710|182950324|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for capsaicin before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2. In addition, we added the STAI state and trait anxiety scores as covariates when assessing the modulation effects of tDCS on the nocebo effect, as previous studies have suggested that anxiety level could affect nocebo hyperalgesia.|Mean Difference (Final Values)|1.3||||0.04|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 1.4, between cathodal vs. sham was 1.0, and between anodal vs. cathodal was -0.3.|To assess the modulation effects of tDCS on nocebo, we first performed an analysis of covariance (ANCOVA) with nocebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.04
91535851|NCT01368406|182950325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.055|TWO_SIDED|95.0|-0.65|1.13|||t-test, 2 sided|t test for independent samples||||1.13|-0.65|0.055
91535852|NCT01368406|182950325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.055|TWO_SIDED|95.0|0.13|0.83|||t-test, 2 sided|||||0.83|0.13|0.055
91535853|NCT04304534|182950326|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.052|||=|0.8439|TWO_SIDED|90.0|0.687|1.612|||Log Rank|||Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group||1.612|0.687|= 0.8439
91535854|NCT04304534|182950326|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.096|||=|0.7562|TWO_SIDED|90.0|0.674|1.781|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.781|0.674|= 0.7562
91535855|NCT04304534|182950326|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.008|||=|0.978|TWO_SIDED|90.0|0.614|1.656|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.656|0.614|= 0.978
91535856|NCT04304534|182950327|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.98|||=|0.9158|TWO_SIDED|90.0|0.713|1.347|||Log Rank|||Comparison of the Pooled Asundexian group versus Placebo group||1.347|0.713|= 0.9158
91535857|NCT04304534|182950327|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.867|||=|0.5633|TWO_SIDED|90.0|0.577|1.302|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||1.302|0.577|= 0.5633
91535858|NCT04304534|182950327|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.875|||=|0.584|TWO_SIDED|90.0|0.587|1.306|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.306|0.587|= 0.584
91761724|NCT02106403|183414423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.13|||<|0.0001|TWO_SIDED|95.0|6.23|18.04|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.04|6.23|<0.0001
91761725|NCT02106403|183414423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.18||||0.4645|TWO_SIDED|95.0|-8.09|3.72|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||3.72|-8.09|0.4645
91761726|NCT02106403|183414423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.32|||<|0.0001|TWO_SIDED|95.0|8.41|20.22|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||20.22|8.41|<0.0001
91761727|NCT02106403|183414424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.41||||0.0357|TWO_SIDED|95.0|0.44|12.38|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||12.38|0.44|0.0357
91761728|NCT02106403|183414424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02||||0.503|TWO_SIDED|95.0|-3.95|8.0|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.00|-3.95|0.5030
91761729|NCT02106403|183414424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.1482|TWO_SIDED|95.0|-1.59|10.36|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.36|-1.59|0.1482
91761730|NCT01496846|183414426|SUPERIORITY|||||||0.901|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.901
91761731|NCT01496846|183414426|SUPERIORITY|||||||0.004|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.004
91535859|NCT04304534|182950327|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|1.202|||=|0.417|TWO_SIDED|90.0|0.828|1.747|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.747|0.828|= 0.417
91761732|NCT01496846|183414427|SUPERIORITY|||||||0.437|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.437
91761733|NCT02024724|183414434|SUPERIORITY||Median Difference (Final Values)|-30.0||||0.196|TWO_SIDED|95.0|-45.0|10.0|||Chi-squared|||||10.00|-45.00|.196
91761734|NCT02019875|183414435|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.884|TWO_SIDED|95.0|-21.2|18.3|||Mixed Models Analysis|||||18.3|-21.2|0.884
91761735|NCT02019875|183414435|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.955|TWO_SIDED|95.0|-19.5|20.7|||Mixed Models Analysis|||||20.7|-19.5|0.955
91761736|NCT02019875|183414435|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.53|TWO_SIDED|95.0|-26.5|13.6|||Mixed Models Analysis|||||13.6|-26.5|0.53
91761737|NCT02019875|183414435|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.434|TWO_SIDED|95.0|-27.6|11.9|||Mixed Models Analysis|||||11.9|-27.6|0.434
91761738|NCT02019875|183414435|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.796|TWO_SIDED|95.0|-24.2|18.6|||Mixed Models Analysis|||||18.6|-24.2|0.796
91761739|NCT02019875|183414436|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.62|TWO_SIDED|95.0|-6.0|3.6|||Mixed Models Analysis|||||3.6|-6.0|0.62
91761740|NCT02019875|183414436|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.482|TWO_SIDED|95.0|-3.1|6.7|||Mixed Models Analysis|||||6.7|-3.1|0.482
91761741|NCT02019875|183414436|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.559|TWO_SIDED|95.0|-3.4|6.4|||Mixed Models Analysis|||||6.4|-3.4|0.559
91761742|NCT02019875|183414436|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.138|TWO_SIDED|95.0|-1.2|8.5|||Mixed Models Analysis|||||8.5|-1.2|0.138
91761743|NCT02019875|183414436|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.477|TWO_SIDED|95.0|-7.1|3.3|||Mixed Models Analysis|||||3.3|-7.1|0.477
91761744|NCT02019875|183414437|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|-11.0|11.3|||Mixed Models Analysis|||||11.3|-11.0|0.98
91761745|NCT02019875|183414437|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.81|TWO_SIDED|95.0|-10.0|12.7|||Mixed Models Analysis|||||12.7|-10.0|0.81
91761746|NCT02019875|183414437|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.91|TWO_SIDED|95.0|-10.8|12.2|||Mixed Models Analysis|||||12.2|-10.8|0.91
91761747|NCT02019875|183414437|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-8.9|13.8|||Mixed Models Analysis|||||13.8|-8.9|0.68
91761748|NCT02019875|183414437|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.96|TWO_SIDED|95.0|-11.9|12.6|||Mixed Models Analysis|||||12.6|-11.9|0.96
91761749|NCT02019875|183414438|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.17|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||||0.5|-2.7|0.17
91761750|NCT02019875|183414438|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.44|TWO_SIDED|95.0|-1.0|2.2|||Mixed Models Analysis|||||2.2|-1.0|0.44
91761751|NCT02019875|183414438|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.7|1.6|||Mixed Models Analysis|||||1.6|-1.7|0.94
91761752|NCT02019875|183414438|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||Mixed Models Analysis|||||5.2|2.1|<0.0001
91761753|NCT02019875|183414438|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.2|5.6|||Mixed Models Analysis|||||5.6|2.2|<0.0001
91761754|NCT02019875|183414439|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.43|TWO_SIDED|95.0|-0.027|0.012|||Mixed Models Analysis|||||0.012|-0.027|0.43
91761755|NCT02019875|183414439|SUPERIORITY||Mean Difference (Final Values)|-0.017||||0.09|TWO_SIDED|95.0|-0.037|0.003|||Mixed Models Analysis|||||0.003|-0.037|0.09
91761756|NCT02019875|183414439|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.29|TWO_SIDED|95.0|-0.031|0.009|||Mixed Models Analysis|||||0.009|-0.031|0.29
91761757|NCT02019875|183414439|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.61|TWO_SIDED|95.0|-0.025|0.015|||Mixed Models Analysis|||||0.015|-0.025|0.61
91761758|NCT02019875|183414439|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.46|TWO_SIDED|95.0|-0.03|0.014|||Mixed Models Analysis|||||0.014|-0.03|0.46
91761759|NCT02019875|183414440|SUPERIORITY||Mean Difference (Final Values)|-12.6||||0.53|TWO_SIDED|95.0|-52.0|26.7|||Mixed Models Analysis|||||26.7|-52.0|0.53
91761760|NCT02019875|183414440|SUPERIORITY||Mean Difference (Final Values)|-44.5||||0.03|TWO_SIDED|95.0|-84.5|-4.5|||Mixed Models Analysis|||||-4.5|-84.5|0.03
91761761|NCT02019875|183414440|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.72|TWO_SIDED|95.0|-47.3|32.8|||Mixed Models Analysis|||||32.8|-47.3|0.72
91761762|NCT02019875|183414440|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.89|TWO_SIDED|95.0|-36.6|42.2|||Mixed Models Analysis|||||42.2|-36.6|0.89
91761763|NCT02019875|183414440|SUPERIORITY||Mean Difference (Final Values)|38.0||||0.08|TWO_SIDED|95.0|-4.7|80.6|||Mixed Models Analysis|||||80.6|-4.7|0.08
91761764|NCT02019875|183414441|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-104.5|110.2|||Mixed Models Analysis|||||110.2|-104.5|0.96
91761765|NCT02019875|183414441|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.79|TWO_SIDED|95.0|-94.2|124.2|||Mixed Models Analysis|||||124.2|-94.2|0.79
91761766|NCT02019875|183414441|SUPERIORITY||Mean Difference (Final Values)|71.3||||0.2|TWO_SIDED|95.0|-37.9|180.5|||Mixed Models Analysis|||||180.5|-37.9|0.20
91761767|NCT02019875|183414441|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.96|TWO_SIDED|95.0|-110.1|104.7|||Mixed Models Analysis|||||104.7|-110.1|0.96
91761768|NCT02019875|183414441|SUPERIORITY||Mean Difference (Final Values)|51.8||||0.38|TWO_SIDED|95.0|-64.7|168.2|||Mixed Models Analysis|||||168.2|-64.7|0.38
91761769|NCT03202134|183414442|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91761770|NCT03202134|183414443|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91761771|NCT03202134|183414444|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91761772|NCT03202134|183414445|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91761773|NCT03202134|183414446|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
91761774|NCT00966550|183414450|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
91761775|NCT01128946|183414451|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.06|||<|0.0001|TWO_SIDED|95.0|19.63|26.48||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||26.48|19.63|<0.0001
91761776|NCT01128946|183414452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.75|||<|0.0001|TWO_SIDED|95.0|7.33|14.17||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.17|7.33|<0.0001
91761777|NCT01128946|183414452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|8.74|15.67||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.67|8.74|<0.0001
91761778|NCT01128946|183414452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.31|||<|0.0001|TWO_SIDED|95.0|8.9|15.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.72|8.90|<0.0001
91761779|NCT01128946|183414452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.46||||0.407|TWO_SIDED|95.0|-2.0|4.91||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||4.91|-2.00|0.4070
91535860|NCT04304534|182950328|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.275|||||TWO_SIDED|90.0|0.322|5.05||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||5.050|0.322|
91535861|NCT04304534|182950328|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.991|||||TWO_SIDED|90.0|0.479|8.273||||||Comparison of the Asundexian 50 mg group versus Placebo group||8.273|0.479|
91535862|NCT04304534|182950329|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.125|||||TWO_SIDED|90.0|0.696|1.819||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group||1.819|0.696|
91535863|NCT04304534|182950329|OTHER||Cox Proportional Hazard|1.181|||||TWO_SIDED|90.0|0.686|2.031||||||Comparison of the Asundexian 20 mg group versus Placebo group||2.031|0.686|
91535864|NCT04304534|182950329|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.07|||||TWO_SIDED|90.0|0.613|1.866||||||Comparison of the Asundexian 50 mg group versus Placebo group||1.866|0.613|
91535865|NCT04304534|182950332|OTHER|For all-cause mortality there is no competing event.|Cox Proportional Hazard|1.266|||=|0.6016|TWO_SIDED|90.0|0.603|2.658|||Log Rank|||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||2.658|0.603|= 0.6016
91535866|NCT04304534|182950332|OTHER||Cox Proportional Hazard|0.996|||=|0.9945|TWO_SIDED|90.0|0.414|2.401|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.401|0.414|= 0.9945
91535867|NCT04304534|182950332|OTHER||Cox Proportional Hazard|1.506|||=|0.4085|TWO_SIDED|90.0|0.667|3.405|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.405|0.667|= 0.4085
91761780|NCT01128946|183414452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.85|||<|0.0001|TWO_SIDED|95.0|-14.3|-7.4||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-7.40|-14.30|<0.0001
91761781|NCT01128946|183414453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.21|||<|0.0001|TWO_SIDED|95.0|11.46|14.96||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||14.96|11.46|<0.0001
91535868|NCT03055767|182950368|SUPERIORITY|||||||0.038|||||||Wilcoxon signed-rank test|||||||0.038
91535869|NCT03055767|182950369|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
91535870|NCT03055767|182950370|SUPERIORITY|||||||0.148|||||||Wilcoxon signed-rank test)|||||||0.148
91535871|NCT03055767|182950371|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
91535872|NCT03055767|182950372|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test)|||||||0.002
91535873|NCT03055767|182950373|SUPERIORITY|||||||0.82|||||||McNemar|||||||0.82
91535874|NCT03055767|182950374|SUPERIORITY|||||||0.006|||||||McNemar|||||||0.006
91535875|NCT03055767|182950375|SUPERIORITY|||||||0.039|||||||McNemar|||||||0.039
91535876|NCT03055767|182950376|SUPERIORITY|||||||0.016|||||||McNemar|||||||0.016
91535877|NCT03055767|182950377|SUPERIORITY|||||||0.18|||||||McNemar|||||||0.18
91535878|NCT03055767|182950378|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test)|||||||<0.001
91535879|NCT03055767|182950379|SUPERIORITY|||||||0.64|||||||Wilcoxon signed-rank test)|||||||0.64
91535880|NCT02228408|182950384|SUPERIORITY|||||||0.04|||||||poisson|||||||0.04
91535881|NCT02228408|182950385|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
91535882|NCT02228408|182950386|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
91535883|NCT02228408|182950390|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
91535884|NCT00606580|182950417|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||0.0001
91761782|NCT01128946|183414453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.79|||<|0.0001|TWO_SIDED|95.0|7.04|10.55||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||10.55|7.04|<0.0001
91761783|NCT01128946|183414453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.03|||<|0.0001|TWO_SIDED|95.0|6.25|9.8||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||9.80|6.25|<0.0001
91535885|NCT00606580|182950417|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||<0.0001
91535886|NCT00606580|182950417|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.871|||||||Chi-squared|||H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||0.871
91535887|NCT00606580|182950418|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||||||0.0006
91761784|NCT01128946|183414453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.41|||<|0.0001|TWO_SIDED|95.0|2.66|6.16||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||6.16|2.66|<0.0001
91761785|NCT01128946|183414453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.3942|TWO_SIDED|95.0|-2.54|1.0||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||1.00|-2.54|0.3942
91761786|NCT01128946|183414453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.18|||<|0.0001|TWO_SIDED|95.0|-6.95|-3.41||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||-3.41|-6.95|<0.0001
91517825|NCT01106833|182910126|SUPERIORITY|||||||0.398||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.398
91761787|NCT02467842|183414455|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|1.02|||||TWO_SIDED|95.0|0.94|1.1||||||GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)||1.10|0.94|
91761788|NCT02467842|183414455|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|0.94|||||TWO_SIDED|95.0|0.87|1.01||||||GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)||1.01|0.87|
91761789|NCT02467842|183414455|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.88|||||TWO_SIDED|95.0|0.82|0.95||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.95|0.82|
91761790|NCT02467842|183414455|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.9|||||TWO_SIDED|95.0|0.83|0.97||||||GMR of A/H1N1 strain (GMTs of TIV/QIV)||0.97|0.83|
91535888|NCT00606580|182950418|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Chi-squared|||||||0.0002
91761791|NCT02467842|183414456|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-6.07|4.06||||||Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)||4.06|-6.07|
91761792|NCT02467842|183414456|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-5.02|||||TWO_SIDED|95.0|-10.08|0.04||||||Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)||0.04|-10.08|
91761793|NCT02467842|183414456|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-7.06|||||TWO_SIDED|95.0|-13.12|-1.0||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-1.00|-13.12|
91761794|NCT02467842|183414456|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-3.09|||||TWO_SIDED|95.0|-9.26|3.09||||||Diff. SCR of B/Victoria (SCR of TIV minus QIV)||3.09|-9.26|
91761795|NCT02467842|183414460|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.7|0.81||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.81|0.70|
91761796|NCT02467842|183414460|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||GMR of B/Victoria (GMTs of TIV/QIV)||0.81|0.69|
91761797|NCT02467842|183414461|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-18.98|||||TWO_SIDED|95.0|-24.61|-13.36||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-13.36|-24.61|
91761798|NCT02467842|183414461|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-12.62|||||TWO_SIDED|95.0|-18.79|-6.45||||||Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)||-6.45|-18.79|
91761799|NCT00766051|183414477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|1.76|<|0.005|TWO_SIDED|95.0|5.0|11.0||The P value is not adjusted for multiple comparisons or for statistical significance|t-test, 2 sided|||The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.||11|5|<0.005
91761800|NCT00766051|183414478|SUPERIORITY_OR_OTHER||Slope|0.275|||<|0.01|||||||Mixed Models Analysis|This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.||Pearson Correlation, 2-tailed||||< 0.01
91761801|NCT00766051|183414479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_DEVIATION|5.2|<|0.02|ONE_SIDED|95.0||6.7|||t-test, 1 sided||An increase in this test scale score means more parent confidence.|"Parent pre-post one sided t test of parents' global confidence, measured parental confidence in feeding, handling, and interacting with their infant."||6.7||< .02
91761802|NCT00766051|183414480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_DEVIATION|4.3|<|0.03|ONE_SIDED|95.0||4.54|||t-test, 1 sided||An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.|Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .||4.54||< .03
91761803|NCT01320202|183414481|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.4||0.011|TWO_SIDED|||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
91761804|NCT00635882|183414496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
91761805|NCT00635882|183414496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.003
91761806|NCT00635882|183414496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.018
91761807|NCT00635882|183414497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
91761808|NCT00635882|183414497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
91761809|NCT00635882|183414497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
91761810|NCT00635882|183414498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.024
91761811|NCT00635882|183414498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.051
91761812|NCT00635882|183414498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.336
91535889|NCT00606580|182950418|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.767|||||||Chi-squared|||||||0.767
91535890|NCT00606580|182950419|SUPERIORITY_OR_OTHER|||||||0.33|||||||Log Rank|Mantel-Cox (log-rank) grouped failure time test using proportion re-epithelialized at each of the scheduled assessments through Day 42 without relapse||||||0.330
91535891|NCT00606580|182950419|SUPERIORITY_OR_OTHER|||||||0.275|||||||Log Rank|||||||0.275
91535892|NCT00606580|182950419|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.83|||||||Log Rank|||||||0.830
91535893|NCT00606580|182950424|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
91535894|NCT00606580|182950424|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91535895|NCT00606580|182950424|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.725|||||||Chi-squared|||||||0.725
91535896|NCT00606580|182950425|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
91535897|NCT00606580|182950425|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
91761813|NCT00635882|183414499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.120
91761814|NCT00635882|183414499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.103
91535898|NCT00606580|182950425|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||1|||||||Chi-squared|||||||1.000
91535899|NCT00606580|182950426|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
91535900|NCT00606580|182950426|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
91535901|NCT00606580|182950426|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.893|||||||Chi-squared|||||||0.893
91535902|NCT00606580|182950427|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91535903|NCT00606580|182950427|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91535904|NCT00606580|182950427|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.247|||||||Chi-squared|||||||0.247
91535905|NCT00606580|182950428|SUPERIORITY_OR_OTHER|||||||0.409|||||||Chi-squared|||||||0.409
91535906|NCT00606580|182950428|SUPERIORITY_OR_OTHER|||||||0.651|||||||Chi-squared|||||||0.651
91761815|NCT00635882|183414499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.048
91761816|NCT00635882|183414500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way analysis of variance (ANOVA) model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.018
91761817|NCT00635882|183414500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.261
91761818|NCT00635882|183414500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.334
91761819|NCT00635882|183414501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.037
91761820|NCT00635882|183414501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.643
91761821|NCT00635882|183414501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.963
91761822|NCT00635882|183414502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
91761823|NCT00635882|183414502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.002
91761824|NCT00635882|183414502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
91761825|NCT00635882|183414503|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
91761826|NCT00635882|183414503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.057
91535907|NCT00606580|182950428|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.701|||||||Chi-squared|||||||0.701
91761827|NCT00635882|183414503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.005
91761828|NCT06037408|183414510|SUPERIORITY||Mean Difference (Final Values)|-57.13|STANDARD_ERROR_OF_MEAN|2.759||0.0001|TWO_SIDED|95.0|-63.99|-50.27||Sidak's test was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom, 42.19||||-50.27|-63.99|0.0001
91761829|NCT06037408|183414511|SUPERIORITY||Mean Difference (Final Values)|25.12|STANDARD_ERROR_OF_MEAN|4.459|<|0.0001|TWO_SIDED|95.0|13.26|36.99|||ANOVA|Degrees of freedom, 28.16.||||36.99|13.26|<0.0001
91761830|NCT01211340|183414512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.18
91761831|NCT01211340|183414512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Regression, Linear|No significant difference found between groups||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.18
91761832|NCT01211340|183414512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Spearmans rank|No differences found||To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficient||||.18
91761833|NCT01211340|183414513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|95.0|||||Wilcxon Rank Sum Test|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.15
91761834|NCT01211340|183414513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.15
91761835|NCT01211340|183414514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.89
91761836|NCT01211340|183414514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.89
91761837|NCT03139344|183414520|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91761838|NCT03139344|183414520|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91761839|NCT03139344|183414521|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91761840|NCT03139344|183414521|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91761841|NCT03139344|183414522|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
91761842|NCT03139344|183414522|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91761843|NCT03139344|183414523|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
91761844|NCT03139344|183414523|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
91761845|NCT03139344|183414524|SUPERIORITY|||||||0.069|||||||ANOVA|||||||0.069
91761846|NCT03139344|183414524|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
91761847|NCT03139344|183414525|SUPERIORITY|||||||0.118|||||||ANOVA|||||||0.118
91761848|NCT03139344|183414525|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
91761849|NCT03139344|183414526|SUPERIORITY|||||||0.059|||||||ANOVA|||||||0.059
91761850|NCT03139344|183414526|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
91761851|NCT03139344|183414527|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
91761852|NCT03139344|183414527|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
91761853|NCT03139344|183414528|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
91761854|NCT03139344|183414529|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
91761855|NCT03139344|183414530|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
91761856|NCT03139344|183414531|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
91761857|NCT03139344|183414532|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
91761858|NCT03139344|183414533|SUPERIORITY|||||||0.109|||||||t-test, 2 sided|||||||0.109
91761859|NCT03139344|183414534|SUPERIORITY|||||||0.895|||||||t-test, 2 sided|||||||0.895
91761860|NCT03139344|183414535|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|paired t-test||||||0.573
91761861|NCT03139344|183414536|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|paired t-test||||||0.858
91761862|NCT02697435|183414547|SUPERIORITY||||||<|0.05||||||P-value is calculated.|Mixed Models Analysis|||||||<0.05
91761863|NCT04230213|183414549|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (percentage)|102.56|||||TWO_SIDED|90.0|89.78|117.17|||||Analysis was performed using analysis of variance (ANOVA) model.|||117.17|89.78|
91535908|NCT01444287|182950436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.636|STANDARD_ERROR_OF_MEAN|0.2093||0.0035||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0035
91761864|NCT04230213|183414550|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (Percentage)|105.31|||||TWO_SIDED|90.0|89.16|124.39|||||Analysis was performed using ANOVA model.|||124.39|89.16|
91761865|NCT00524472|183414580|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.0043|TWO_SIDED|95.0|0.39|0.97||"P-values for combined sites: significant if P \< 0.0085 for efficacy. Adjusted for interim analysis.~Confidence intervals adjusted for interim analysis."|Cochran-Mantel-Haenszel||Hyperinsulinemic-normoglycemic clamp|||0.97|0.39|0.0043
91761866|NCT00524472|183414581|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.29|TWO_SIDED|95.0|0.75|1.13|||Cochran-Mantel-Haenszel||HN vs. standard|||1.13|0.75|0.29
91761867|NCT00524472|183414582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.99|TWO_SIDED|95.0|0.91|1.21|||Regression, Cox|||||1.21|0.91|0.99
91761868|NCT00524472|183414583|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.025|TWO_SIDED|95.0|0.98|1.31|||Regression, Cox||HN vs. Standard|||1.31|0.98|0.025
91761869|NCT00524472|183414584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52||||0.12|TWO_SIDED|95.0|0.74|3.11|||Cochran-Mantel-Haenszel||HN vs. standard|||3.11|0.74|0.12
91761870|NCT00524472|183414585|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.085|TWO_SIDED|95.0|0.72|1.07|||Cochran-Mantel-Haenszel||HN vs. Standard|||1.07|0.72|0.085
91761871|NCT02748070|183414586|OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.819
91761872|NCT02748070|183414586|OTHER|||||||0.665|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.665
91761873|NCT02748070|183414586|OTHER|||||||0.071|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.071
91761874|NCT02748070|183414586|OTHER|||||||0.097|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.097
91761875|NCT02748070|183414587|OTHER|||||||0.376|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.376
91761876|NCT02748070|183414587|OTHER|||||||0.685|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.685
91761877|NCT02748070|183414587|OTHER|||||||0.388|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.388
91761878|NCT02748070|183414587|OTHER|||||||0.233|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.233
91761879|NCT00928694|183414598|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true geometric mean ratios (GMRs) \[U.S./UK\] for the AUC(0 to infinity) and maximum plasma concentration (Cmax) of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.96||||||90.0|0.9|1.02||||||||1.02|0.90|
91761880|NCT00928694|183414599|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true GMRs \[U.S./UK\] for the AUC(0 to infinity) and Cmax of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.98||||||90.0|0.9|1.06||||||||1.06|0.90|
91761881|NCT04412707|183414627|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.946|||||TWO_SIDED|90.0|0.849|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.849|
91535909|NCT01444287|182950436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.743|STANDARD_ERROR_OF_MEAN|0.2093||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control - Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
91535910|NCT01444287|182950436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0275|STANDARD_ERROR_OF_MEAN|0.2093||0.8957||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8957
91535911|NCT01444287|182950437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0031||0.0692||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0692
91761882|NCT04412707|183414628|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.952|||||TWO_SIDED|90.0|0.861|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.861|
91761883|NCT04412707|183414629|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.955|||||TWO_SIDED|90.0|0.863|1.058|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.058|0.863|
91761884|NCT04412707|183414631|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.948|||||TWO_SIDED|90.0|0.736|1.222|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.222|0.736|
91535912|NCT01444287|182950437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0011|STANDARD_ERROR_OF_MEAN|0.0032||0.7301||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.7301
91535913|NCT01444287|182950437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0008|STANDARD_ERROR_OF_MEAN|0.0032||0.8055||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8055
91535914|NCT01444287|182950438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0122|STANDARD_ERROR_OF_MEAN|0.1111||0.9127||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9127
91535915|NCT01444287|182950438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6864|STANDARD_ERROR_OF_MEAN|0.1098||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
91535916|NCT01444287|182950438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1705|STANDARD_ERROR_OF_MEAN|0.1098||0.1256||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.1256
91535917|NCT01444287|182950439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|5.044||0.9892||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9892
91535918|NCT01444287|182950439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|4.984||0.0007||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0007
91535919|NCT01444287|182950439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|4.984||0.003||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.0030
91535920|NCT02427737|182950449|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
91535921|NCT02427737|182950449|SUPERIORITY|||||||0.3037||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.3037
91535922|NCT02427737|182950449|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.01
91535923|NCT02427737|182950450|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
91535924|NCT02427737|182950450|SUPERIORITY|||||||0.201||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.2010
91535925|NCT02427737|182950450|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
91535926|NCT02427737|182950451|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Comparison among trained and untrained sites||||<0.0001
91535927|NCT02427737|182950451|SUPERIORITY|||||||0.303||||||"Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.~Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2)."|Chi-squared|||Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites||||0.303
91535928|NCT02427737|182950451|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
91761885|NCT04412707|183414631|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|[adjusted geometric mean ratio (GMR)]|0.846|||||TWO_SIDED|90.0|0.748|0.957|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For desmethyl-melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.957|0.748|
91535929|NCT02427737|182950452|SUPERIORITY||||||<|0.0001||||||CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.|Chi-squared, Corrected|Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.||||||<0.0001
91535930|NCT02427737|182950453|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91535931|NCT02427737|182950455|SUPERIORITY|||||||0.2357||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.2357
91535932|NCT02427737|182950455|SUPERIORITY|||||||0.8523||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter||||0.8523
91535933|NCT02427737|182950455|SUPERIORITY|||||||0.5883||||||Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.|Chi-squared|||Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites||||0.5883
91535934|NCT02427737|182950456|SUPERIORITY|||||||0.0195||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.0195
91535935|NCT02427737|182950456|SUPERIORITY|||||||0.276||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows compared to the baseline quarter||||0.276
91535936|NCT02427737|182950456|SUPERIORITY|||||||0.2764||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter at untrained sites||||0.2764
91535937|NCT02427737|182950457|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.01
91535938|NCT02427737|182950457|SUPERIORITY|||||||0.9012||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the quarterly average no show rate as compared to the baseline quarter for trained sites||||0.9012
91761886|NCT04412707|183414632|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.126|||||Data above refer to meflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.126|0.684|
91535939|NCT02427737|182950457|SUPERIORITY|||||||0.9065||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites||||0.9065
91535940|NCT02427737|182950458|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6||Comparison among trained and untrained sites over time||||<0.0001
91535941|NCT02427737|182950463|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91535942|NCT02427737|182950464|SUPERIORITY|||||||0.2396|||||||Chi-squared|||||||0.2396
91535943|NCT02427737|182950465|SUPERIORITY|||||||0.5267|||||||Chi-squared|||||||0.5267
91535944|NCT02427737|182950466|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91535945|NCT02427737|182950467|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91535946|NCT00543725|182950468|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.7|||<|0.0001||95.0|-1.6|9.0||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||9.0|-1.6|<0.0001
91761887|NCT04412707|183414632|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.897|||||TWO_SIDED|90.0|0.819|0.982|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.982|0.819|
91761888|NCT04412707|183414633|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.124|||||Data above refer to melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.124|0.684|
91535947|NCT00543725|182950469|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.9|||<|0.0001||95.0|-1.9|9.6|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||9.6|-1.9|<0.0001
91535948|NCT00543725|182950470|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|2.4|||<|0.0001||95.0|-3.6|8.4||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||8.4|-3.6|<0.0001
91535949|NCT00543725|182950471|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.7|||<|0.0001||95.0|-5.6|7.0|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||7.0|-5.6|<0.0001
91535950|NCT03095508|182950481|SUPERIORITY|||||||0.446|||||||Fisher Exact|||||||0.446
91535951|NCT03095508|182950483|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91535952|NCT03095508|182950484|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
91535953|NCT03095508|182950485|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
91535954|NCT03095508|182950486|NON_INFERIORITY|non-inferiority margin 14.5% absolute difference between percentages in group A and B|Risk Difference (RD)|0.14||||1e-05|TWO_SIDED|95.0|0.03|0.24||p- value for superiority: 0.021|Fisher Exact|||p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 - p2 ≤ -0.145||0.24|0.03|0.00001
91761889|NCT04412707|183414633|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.908|||||TWO_SIDED|90.0|0.833|0.989|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.989|0.833|
91535955|NCT00335556|182950487|OTHER||Log Rank Test Statistic|5.419||||0.0199|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.||||.0199
91535956|NCT00335556|182950488|OTHER||Log Rank Test Statistic|0.8814||||0.3478|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.3478
91535957|NCT00335556|182950490|OTHER||Log Rank Test Statistic|3.6216||||0.057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.0570
91535958|NCT01710514|182950550|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative (Ha) by constructing two-sided 95%CI for the difference. The non-inferiority limit for the difference was pre-specified to -10.0% (absolute). If the lower limit of the two-sided 95%CI was greater than the non-inferiority limit (-10.0%) for both the FAS and per protocol set, the null hypothesis was to be rejected. In that case it would be claimed that the rate observed in this trial was non-inferior to the rate observed in the CS08 trial|Difference of % to historical control|-0.9|||||TWO_SIDED|95.0|-3.6|1.8||||||To verify sufficient supplementation of luteal hormone, the proportion of subjects with blood progesterone concentration ≥ 10 ng/mL on Day 5 was compared to the result from a historical control, trial CS08 (NCT number: 00884221). The corresponding proportion of subjects in trial CS08 was 99.8% (95%CI: 99.1;100.0, 631/632 subjects). The non-inferiority hypothesis tested for this primary endpoint was: H0: P(000072)-P(CS08) ≤ -10.0% against the alternative Ha: P(000072)-P(CS08) \> -10.0%.||1.8|-3.6|
91535959|NCT03404843|182950558|OTHER|||||||0.97|||||||ANOVA|||Within group comparison of treatment||||0.97
91535960|NCT03404843|182950558|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
91535961|NCT03404843|182950559|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
91535962|NCT03404843|182950559|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
91761890|NCT00699608|183414647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.267||95.0|-2.74|0.76|||ANCOVA|ANCOVA used (fixed effects: adjusted period baseline, participant baseline, age, gender, period and treatment group; random effect: participant).||||0.76|-2.74|0.267
91761891|NCT03329092|183414685|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-6.6|12.4|||||The confidence interval (CI) for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.4|-6.6|
91761892|NCT03329092|183414686|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-7.0|13.2|||||The CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||13.2|-7.0|
91761893|NCT03329092|183414687|OTHER||Difference in clinical cure rate|0.5|||||TWO_SIDED|95.0|-10.2|12.1|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.1|-10.2|
91761894|NCT03329092|183414688|OTHER||Difference in clinical cure rate|2.6|||||TWO_SIDED|95.0|-8.4|14.7|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||14.7|-8.4|
91761895|NCT03329092|183414689|OTHER||Difference in clinical cure rate|2.4|||||TWO_SIDED|95.0|-7.4|13.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.0|-7.4|
91761896|NCT03329092|183414689|OTHER||Difference in clinical cure rate|4.3|||||TWO_SIDED|95.0|-15.5|23.1|||Difference||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.1|-15.5|
91761897|NCT03329092|183414690|OTHER||Difference in clinical cure rate|5.6|||||TWO_SIDED|95.0|-4.0|16.6|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||16.6|-4.0|
91761898|NCT03329092|183414690|OTHER||Difference in clinical cure rate|-7.9|||||TWO_SIDED|95.0|-31.9|17.3|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||17.3|-31.9|
91761899|NCT03329092|183414717|OTHER||Difference in clinical cure rate|2.3|||||TWO_SIDED|95.0|-6.2|11.5|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||11.5|-6.2|
91761900|NCT03329092|183414718|OTHER||Difference in clinical cure|-1.2|||||TWO_SIDED|95.0|-10.7|9.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.4|-10.7|
91761901|NCT03329092|183414719|OTHER||Difference in clinical cure|0.3|||||TWO_SIDED|95.0|-8.3|9.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.9|-8.3|
91761902|NCT03329092|183414720|OTHER||Difference in clinical cure rate|1.0|||||TWO_SIDED|95.0|-8.5|12.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.0|-8.5|
91761903|NCT03329092|183414721|OTHER||Difference in clinical cure rate|1.9|||||TWO_SIDED|95.0|-6.9|11.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||11.9|-6.9|
91761904|NCT03329092|183414721|OTHER||Difference in clinical cure rate|3.9|||||TWO_SIDED|95.0|-15.2|23.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.4|-15.2|
91761905|NCT03329092|183414722|OTHER||Difference in clinical cure rate|3.1|||||TWO_SIDED|95.0|-5.2|13.2|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.2|-5.2|
91761906|NCT03329092|183414722|OTHER||Difference in clinical cure rate|-10.4|||||TWO_SIDED|95.0|-32.6|14.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||14.9|-32.6|
91761907|NCT02206035|183414797|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Comparison at Baseline||||0.95
91761908|NCT02206035|183414797|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||Comparison at Day 28||||0.26
91761909|NCT02206035|183414797|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
91761910|NCT02206035|183414797|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Comparison at Day 180||||0.76
91761911|NCT02206035|183414798|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Comparison at Baseline||||0.99
91761912|NCT02206035|183414798|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Comparison at Day 28||||0.48
91535963|NCT03404843|182950560|OTHER|||||||0.28|||||||ANOVA|||Within group comparison of treatment||||0.28
91761913|NCT02206035|183414798|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
91761914|NCT02206035|183414798|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Comparison at Day 180||||0.96
91761915|NCT02206035|183414799|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison at Baseline||||<0.001
91761916|NCT02206035|183414799|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison at Day 28||||0.75
91761917|NCT02206035|183414799|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Comparison at Day 100||||0.28
91761918|NCT02206035|183414799|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Comparison at Day 180||||0.82
91761919|NCT02206035|183414800|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||Comparison at Baseline||||0.54
91761920|NCT02206035|183414800|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Comparison at Day 28||||0.61
91761921|NCT02206035|183414800|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Comparison at Day 100||||0.42
91761922|NCT02206035|183414800|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Comparison at Day 180||||0.38
91761923|NCT02206035|183414801|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Comparison at Baseline||||0.10
91761924|NCT02206035|183414801|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Comparison at Day 28||||0.32
91761925|NCT02206035|183414801|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
91761926|NCT02206035|183414801|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Comparison at Day 180||||0.30
91761927|NCT01934010|183414802|SUPERIORITY|||||||0.128|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 2 treatment cycles.||||0.128
91761928|NCT01934010|183414802|SUPERIORITY|||||||0.075|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 3 treatment cycles.||||0.075
91761929|NCT01934010|183414802|SUPERIORITY|||||||1|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 2 treatment cycles with AM-101 or others who received 3 treatment cycles.||||1
91761930|NCT01934010|183414803|SUPERIORITY|||||||0.4403|||||||Fisher Exact|||||||0.4403
91761931|NCT01934010|183414805|SUPERIORITY|||||||0.2401|||||||Fisher Exact|||||||0.2401
91761932|NCT01934010|183414805|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||||||0.0022
91761933|NCT01934010|183414805|SUPERIORITY|||||||0.1001|||||||Fisher Exact|||||||0.1001
91761934|NCT01934010|183414806|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91535964|NCT03404843|182950560|OTHER|||||||0.37|||||||ANOVA|||Within group comparison of treatment||||0.37
91535965|NCT03404843|182950561|OTHER|||||||0.89|||||||ANOVA|||Within group comparison of treatment||||0.89
91535966|NCT03404843|182950561|OTHER|||||||0.3|||||||ANOVA|||Within group comparison of treatment||||0.30
91535967|NCT03404843|182950562|OTHER|||||||0.08|||||||ANOVA|||Within group comparison of treatment||||0.08
91535968|NCT03404843|182950562|OTHER|||||||0.05|||||||ANOVA|||Within group comparison of treatment||||0.05
91535969|NCT00567164|182950564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.85|STANDARD_DEVIATION|30.356||0.0001||95.0|-16.3|-7.394|||t-test, 2 sided|||||-7.394|-16.3|0.0001
91535970|NCT02595398|182950591|SUPERIORITY||Difference in percentages|31.25|||<|0.001|TWO_SIDED|95.0|15.5|45.9||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between country strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the country, i.e., US+Israel and India.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|A total sample size of 150 subjects in a 3:2 randomization had 90% power to detect a difference between treatments in the proportion of subjects showing improvement is 0.60 for treated and 0.34 for sham. The primary analysis was a test of superiority of the CLS-TA arm over the sham arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by country.||45.9|15.5|<0.001
91761935|NCT00377858|183414811|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.|Mean Difference (Net)|0.17||||0.097||95.0|-0.03|0.37|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).|Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.||0.37|-0.03|0.097
91761936|NCT00377858|183414812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.047||95.0|0.0|0.33||P-value for 12 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.33|0.00|0.047
91761937|NCT00377858|183414812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.043||95.0|0.01|0.35||P-value for 24 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|0.01|0.043
91761938|NCT00377858|183414812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.343||95.0|-0.1|0.29||P-value for 36 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.10|0.343
91761939|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.432||95.0||||P-value for Week 12: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.432
91761940|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value for 12 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.602
91761941|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value for 12 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.370
91761942|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value for 24 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.198
91761943|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value for 24 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.636
91761944|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value for 24 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.185
91761945|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value for 36 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.393
91761946|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value for 36 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.739
91761947|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||P-value for 36 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.396
91761948|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.227||95.0||||P-value for Endpoint (LOCF): HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.227
91761949|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value for Endpoint (LOCF): HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.482
91761950|NCT00377858|183414813|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for Endpoint (LOCF): HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.108
91761951|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.014||95.0|0.12|1.04||P-value for Baseline: Morning Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.04|0.12|0.014
91761952|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.735||95.0|-0.51|0.72||P-value for Baseline: Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.72|-0.51|0.735
91761953|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.051||95.0|0.0|1.08||P-value for Baseline: Midday Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.08|-0.00|0.051
91761954|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.536||95.0|-0.39|0.75||P-value for Baseline: Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.75|-0.39|0.536
91761955|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.793||95.0|-0.48|0.62||P-value for Baseline: Evening Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.48|0.793
91761956|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.693||95.0|-0.43|0.64||P-value for Baseline: Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.64|-0.43|0.693
91761957|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.499||95.0|-0.38|0.77||P-value for Baseline: 0300 Hours.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.77|-0.38|0.499
91761958|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|||<|0.001||95.0|0.26|0.92||P-value for 12 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.92|0.26|<0.001
91761959|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.278||95.0|-0.22|0.78||P-value for 12 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.78|-0.22|0.278
91761960|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.53||||0.009||95.0|0.14|0.93||P-value for 12 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.93|0.14|0.009
91535971|NCT03410992|182950731|SUPERIORITY||Odds Ratio (OR)|496.318|||<|0.001|TWO_SIDED|95.0|82.798|2975.086||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2975.086|82.798|<0.001
91761961|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.049||95.0|0.0|0.97||P-value for 12 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.97|0.00|0.049
91761962|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||<|0.001||95.0|0.35|1.18||P-value for 12 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.18|0.35|<0.001
91761963|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.17|||<|0.001||95.0|-1.63|-0.7||P-value for 12 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.70|-1.63|<0.001
91761964|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.506||95.0|-0.59|0.29||P-value for 12 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.59|0.506
91761965|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65|||<|0.001||95.0|0.31|0.99||P-value for 24 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.99|0.31|<0.001
91761966|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.094||95.0|-0.07|0.91||P-value for 24 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.91|-0.07|0.094
91761967|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.408||95.0|-0.24|0.59||P-value for 24 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.59|-0.24|0.408
91535972|NCT03410992|182950732|SUPERIORITY||Odds Ratio (OR)|657.255|||<|0.001|TWO_SIDED|95.0|105.792|4083.333||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||4083.333|105.792|<0.001
91761968|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.351||95.0|-0.25|0.71||P-value for 24 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.71|-0.25|0.351
91761969|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.01||95.0|0.13|0.98||P-value for 24 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.98|0.13|0.010
91761970|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.029||95.0|-0.92|-0.05||P-value for 24 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.92|0.029
91761971|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.816||95.0|-0.45|0.35||P-value for 24 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|-0.45|0.816
91761972|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.008||95.0|0.13|0.85||P-value for 36 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.85|0.13|0.008
91761973|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.438||95.0|-0.71|0.31||P-value for 36 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.31|-0.71|0.438
91761974|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.548||95.0|-0.54|0.29||P-value for 36 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.54|0.548
91761975|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.964||95.0|-0.5|0.52||P-value for 36 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.52|-0.50|0.964
91761976|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.453||95.0|-0.27|0.6||P-value for 36 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.60|-0.27|0.453
91761977|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.096||95.0|-0.84|0.07||P-value for 36 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.84|0.096
91761978|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.77||95.0|-0.51|0.37||P-value for 36 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.37|-0.51|0.770
91761979|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.01||95.0|0.11|0.8||P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.80|0.11|0.010
91761980|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.201||95.0|-0.8|0.17||P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.17|-0.80|0.201
91761981|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.43||95.0|-0.57|0.24||P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.24|-0.57|0.430
91761982|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.814||95.0|-0.52|0.41||P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.41|-0.52|0.814
91535973|NCT03410992|182950733|SUPERIORITY||Odds Ratio (OR)|220.038|||<|0.001|TWO_SIDED|95.0|28.757|1683.639||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1683.639|28.757|<0.001
91535974|NCT03410992|182950734|SUPERIORITY||Odds Ratio (OR)|224.744|||<|0.001|TWO_SIDED|95.0|30.13|1676.425||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1676.425|30.130|<0.001
91535975|NCT03410992|182950735|SUPERIORITY||Odds Ratio (OR)|316.641|||<|0.001|TWO_SIDED|95.0|39.423|2543.254||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2543.254|39.423|<0.001
91535976|NCT03410992|182950736|SUPERIORITY||Odds Ratio (OR)|34.325|||<|0.001|TWO_SIDED|95.0|14.22|82.856||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||82.856|14.220|<0.001
91535977|NCT03410992|182950737|SUPERIORITY||Odds Ratio (OR)|43.497|||<|0.001|TWO_SIDED|95.0|15.728|120.295||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||120.295|15.728|<0.001
91535978|NCT03410992|182950738|SUPERIORITY||Odds Ratio (OR)|60.946|||<|0.001|TWO_SIDED|95.0|20.56|180.669||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.||180.669|20.560|<0.001
91535979|NCT03410992|182950739|SUPERIORITY||Odds Ratio (OR)|158.0|||<|0.001|TWO_SIDED|95.0|49.263|506.745||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||506.745|49.263|<0.001
91535980|NCT03410992|182950740|SUPERIORITY||Odds Ratio (OR)|45.192|||<|0.001|TWO_SIDED|95.0|18.622|109.672||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||109.672|18.622|<0.001
91535981|NCT03410992|182950740|SUPERIORITY||Odds Ratio (OR)|49.297|||<|0.001|TWO_SIDED|95.0|18.887|128.673||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||128.673|18.887|<0.001
91761983|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.427||95.0|-0.24|0.57||P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.57|-0.24|0.427
91761984|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.009||95.0|-1.0|-0.14||P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.14|-1.00|0.009
91761985|NCT00377858|183414814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.569||95.0|-0.51|0.28||P-value for Endpoint: 0300 Hours. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.28|-0.51|0.569
91761986|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.776||95.0|-0.14|0.19||P-value for Baseline MODD.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.19|-0.14|0.776
91761987|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27||||0.737||95.0|-6.14|8.68||P-value for Baseline M-Value.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.68|-6.14|0.737
91761988|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.701||95.0|-0.19|0.13||P-value for 12 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.13|-0.19|0.701
91761989|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58||||0.4||95.0|-2.11|5.27||P-value for 12 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||5.27|-2.11|0.400
91761990|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.321||95.0|-0.26|0.09||P-value for 24 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.09|-0.26|0.321
91761991|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.179||95.0|-1.16|6.21||P-value for 24 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||6.21|-1.16|0.179
91761992|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.573||95.0|-0.22|0.12||P-value for 36 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|-0.22|0.573
91761993|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.629||95.0|-4.79|2.9||P-value for 36 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||2.90|-4.79|0.629
91761994|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.25||95.0|-0.26|0.07||P-value for Endpoint MODD. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.26|0.250
91761995|NCT00377858|183414815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.72||||0.362||95.0|-5.44|1.99||P-value for Endpoint M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.99|-5.44|0.362
91761996|NCT00377858|183414816|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Endpoint Hypoglycemic Episodes.|Fisher Exact|||||||0.094
91761997|NCT00377858|183414816|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Hypoglycemic Episodes.|Fisher Exact|||||||1.00
91761998|NCT00377858|183414816|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.430
91761999|NCT00377858|183414816|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||1.00
91762000|NCT00377858|183414816|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.013
91762001|NCT00377858|183414816|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.756
91762002|NCT00377858|183414817|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Endpoint Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.022
91762003|NCT00377858|183414817|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Overall Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.218
91762004|NCT00377858|183414817|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.311
91762005|NCT00377858|183414817|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.615
91762006|NCT00377858|183414817|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.018
91762007|NCT00377858|183414817|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.255
91762008|NCT00377858|183414818|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Overall Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.416
91762009|NCT00377858|183414819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|||<|0.001||95.0|-0.12|-0.05||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.12|<0.001
91762010|NCT00377858|183414819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||<|0.001||95.0|0.04|0.11||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.11|0.04|<0.001
91762011|NCT00377858|183414819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.017||95.0|0.01|0.12||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|0.01|0.017
91762012|NCT00377858|183414820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.96|||<|0.001||95.0|-9.65|-4.26||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-4.26|-9.65|<0.001
91762013|NCT00377858|183414820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.05|||<|0.001||95.0|3.39|8.71||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.71|3.39|<0.001
91762014|NCT00377858|183414820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2||||0.017||95.0|0.93|9.46||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||9.46|0.93|0.017
91762015|NCT00377858|183414821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||<|0.001||95.0|0.24|0.42||P-value for Week 12.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.42|0.24|<0.001
91762016|NCT00377858|183414821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.003||95.0|0.07|0.36||P-value for Week 24.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.36|0.07|0.003
91762017|NCT00377858|183414821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.002||95.0|0.09|0.4||P-value for Week 30.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.40|0.09|0.002
91762018|NCT00377858|183414821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.005||95.0|0.07|0.38||P-value for Week 36.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.38|0.07|0.005
91762019|NCT00377858|183414821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.011||95.0|0.04|0.34||P-value for Endpoint. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.34|0.04|0.011
91762020|NCT00377858|183414822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.803||95.0|-0.8|0.62||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.80|0.803
91762021|NCT04042909|183414829|SUPERIORITY||beta coefficient|-0.309|STANDARD_ERROR_OF_MEAN|0.69||0.646|TWO_SIDED|95.0|-1.632|1.013||This is the p-value of the CAA vs AO factor in the model.|Regression, Linear|We used linear regression, controlling for baseline value of outcome and sex, to determine change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol consumption (drinks per week) from baseline to 6-months.||1.013|-1.632|.646
91762022|NCT04042909|183414830|SUPERIORITY||beta coefficient|-1.9|STANDARD_ERROR_OF_MEAN|0.77||0.014|TWO_SIDED|95.0|-3.41|-0.39|||Regression, Linear|We used regression, controlling for baseline value of outcome and sex, to determine pre-post change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol problems from baseline to 6-months.||-0.39|-3.41|.014
91762023|NCT01147055|183414843|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|18.21|||||TWO_SIDED|90.0|16.14|20.54||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.54|16.14|
91762024|NCT01147055|183414844|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|31.49|||||TWO_SIDED|90.0|26.43|37.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||37.51|26.43|
91762025|NCT01147055|183414845|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|17.6|||||TWO_SIDED|90.0|15.48|20.02||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.02|15.48|
91762026|NCT01147055|183414850|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.49|||||TWO_SIDED|90.0|4.64|6.49||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.49|4.64|
91762027|NCT01147055|183414851|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.75|||||TWO_SIDED|90.0|4.86|6.81||||||Natural log transformed AUC (0 - ∞) of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.81|4.86|
91762028|NCT01147055|183414853|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|11.01|||||TWO_SIDED|90.0|9.02|13.45||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||13.45|9.02|
91762029|NCT02123823|183414942|OTHER||Hazard Ratio, log|0.97||||0.9057|TWO_SIDED|95.0|0.57|1.65|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.65|0.57|0.9057
91762030|NCT02123823|183414945|OTHER||Odds Ratio, log|0.7||||0.5598|TWO_SIDED|95.0|0.2|2.32|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement at screening.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.32|0.20|0.5598
91762031|NCT02123823|183414946|OTHER||Hazard Ratio, log|1.03||||0.9146|TWO_SIDED|95.0|0.59|1.8|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.80|0.59|0.9146
91762032|NCT02123823|183414947|OTHER||Odds Ratio, log|0.7||||0.4008|TWO_SIDED|95.0|0.31|1.59|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||1.59|0.31|0.4008
91535982|NCT03410992|182950740|SUPERIORITY||Odds Ratio (OR)|47.406|||<|0.001|TWO_SIDED|95.0|22.087|101.75||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||101.750|22.087|<0.001
91535983|NCT04988295|182950761|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.56|||Log Rank|||||0.56|0.35|<0.0001
91535984|NCT04988295|182950761|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001||95.0|0.36|0.64|||Log Rank|||||0.64|0.36|<0.0001
91762033|NCT01635855|183414955|SUPERIORITY_OR_OTHER||One-sided binomial|8.5|||<|0.025|TWO_SIDED|95.0|3.5|13.6||Ho (null): Ps \>= 22% versus Ha (alternate): Ps \< 22% where Ps is the proportion of subjects with common severe adverse events in the post-approval study. Ho is rejected if upper limit of the 95% CI of Ps \< 22% and the one-sided p-value \<= 0.025.|One sided binomial distribution|The upper limit of the 95% two-sided CI for a proportion is equivalent to the 97.5% one-sided CI for that proportion for normal approximations.||The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.||13.6|3.5|< 0.025
91762034|NCT00095173|183414973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0002|TWO_SIDED|95.0|0.16|0.59|||Log Rank||Abatacept over placebo|||0.59|0.16|0.0002
91762035|NCT00095173|183414974|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91535985|NCT02657629|182950780|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91535986|NCT00516503|182950781|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
91762036|NCT02343406|183414988|OTHER||Cox Proportional Hazard|0.71|||=|0.062|TWO_SIDED|95.0|0.5|1.02||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.02|0.5|= 0.062
91762037|NCT02343406|183414988|OTHER||Cox Proportional Hazard|1.04|||=|0.835|TWO_SIDED|95.0|0.73|1.48||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.48|0.73|= 0.835
91762038|NCT02343406|183414989|OTHER||Cox Proportional Hazard|0.77|||=|0.123|TWO_SIDED|95.0|0.55|1.07||2-sided|Log Rank|||||1.07|0.55|= 0.123
91762039|NCT02343406|183414989|OTHER||Cox Proportional Hazard|1.31|||=|0.117|TWO_SIDED|95.0|0.93|1.84||2-sided|Log Rank|||||1.84|0.93|= 0.117
91762040|NCT02343406|183414997|OTHER||Odds Ratio (OR)|3.1|||=|0.06|TWO_SIDED|95.0|0.6|16.16||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||16.16|0.6|= 0.06
91762041|NCT02343406|183414997|OTHER||Odds Ratio (OR)|1.21|||=|0.767|TWO_SIDED|95.0|0.12|12.49||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||12.49|0.12|= 0.767
91762042|NCT02343406|183414998|OTHER||Cox Proportional Hazard|0.67|||=|0.127|TWO_SIDED|95.0|0.4|1.13||2-sided|Log Rank|||||1.13|0.4|= 0.127
91762043|NCT02343406|183414998|OTHER||Cox Proportional Hazard|0.88|||=|0.64|TWO_SIDED|95.0|0.52|1.49||2-sided|Log Rank|||||1.49|0.52|= 0.64
91535987|NCT00516503|182950782|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
91762044|NCT00874848|183415008|SUPERIORITY_OR_OTHER|||||||0.2895|||||||Fisher Exact|||||||0.2895
91762045|NCT03089541|183415014|SUPERIORITY||Odds Ratio (OR)|0.17||||0.002|TWO_SIDED|95.0|0.06|0.52|||Regression, Logistic|||Comparison on Eating/Drinking using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||0.52|0.06|0.002
91762046|NCT03089541|183415014|SUPERIORITY||Odds Ratio (OR)|2.65||||0.07|TWO_SIDED|95.0|0.92|7.65|||Regression, Logistic|||Comparison on Traveling using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||7.65|0.92|0.07
91762047|NCT03089541|183415014|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4|TWO_SIDED|95.0|0.59|3.64|||Regression, Logistic|||Comparison on Working/Reading/Studying using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.64|0.59|0.40
91762048|NCT03089541|183415014|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6|TWO_SIDED|95.0|0.51|3.53|||Regression, Logistic|||Comparison on Socializing using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.53|0.51|0.60
91762049|NCT03089541|183415014|SUPERIORITY||Odds Ratio (OR)|1.8||||0.06|TWO_SIDED|95.0|0.96|3.38|||Regression, Logistic|||Model on Public Space adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||3.38|0.96|0.06
91762050|NCT05169424|183415015|OTHER|Comparison of Stiolto (reference group) versus Trelegy for incidence rate of exacerbation.|Hazard Ratio (HR)|1.133||||0.064|TWO_SIDED|95.0|0.993|1.293|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.293|0.993|0.064
91762051|NCT05169424|183415015|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
91762052|NCT05169424|183415015|OTHER|||||||0.063|||||||Log Rank|||||||0.063
91762053|NCT05169424|183415016|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.169||||0.057|TWO_SIDED|95.0|0.996|1.372|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.372|0.996|0.057
91762054|NCT05169424|183415017|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.116||||0.114|TWO_SIDED|95.0|0.974|1.279|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.279|0.974|0.114
91762055|NCT05169424|183415018|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.374||||0.273|TWO_SIDED|95.0|0.779|2.424|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||2.424|0.779|0.273
91762056|NCT05169424|183415019|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.183||||0.429|TWO_SIDED|95.0|0.78|1.792|||Regression, Cox|||||1.792|0.780|0.429
91762057|NCT05169424|183415019|OTHER|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
91762058|NCT05169424|183415019|OTHER|||||||0.932|||||||Log Rank|||||||0.932
91535988|NCT00516503|182950783|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
91762059|NCT05169424|183415020|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|0.979||||0.935|TWO_SIDED|95.0|0.582|1.645|||Regression, Cox|||||1.645|0.582|0.935
91762060|NCT05169424|183415021|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.159||||0.507|TWO_SIDED|95.0|0.75|1.79|||Regression, Cox|||||1.790|0.750|0.507
91762061|NCT05169424|183415022|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.291||||0.726|TWO_SIDED|95.0|0.309|5.405|||Regression, Cox|||||5.405|0.309|0.726
91762062|NCT05169424|183415023|OTHER|||||||0.874|||||||t-test, 2 sided|||||||0.874
91762063|NCT05169424|183415023|OTHER||Exponential estimate|0.895||||0.01|TWO_SIDED|95.0|0.823|0.974|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.974|0.823|0.01
91762064|NCT05169424|183415024|OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
91762065|NCT05169424|183415024|OTHER||Exponential estimate|0.897||||0.012|TWO_SIDED|95.0|0.824|0.976|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.976|0.824|0.012
91762066|NCT05169424|183415025|OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
91762067|NCT05169424|183415025|OTHER||Exponential estimate|1.135||||0.595|TWO_SIDED|95.0|0.711|1.812|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.812|0.711|0.595
91762068|NCT05169424|183415026|OTHER|||||||0.622|||||||t-test, 2 sided|||||||0.622
91762069|NCT05169424|183415026|OTHER||Exponential estimate|1.008||||0.855|TWO_SIDED|95.0|0.928|1.094|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.094|0.928|0.855
91762070|NCT05169424|183415027|OTHER|||||||0.328|||||||t-test, 2 sided|||||||0.328
91762071|NCT01371734|183415065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.587|TWO_SIDED|95.0|-2.23|3.94|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||3.94|-2.23|0.587
91762072|NCT01371734|183415065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52||||0.333|TWO_SIDED|95.0|-1.56|4.61|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||4.61|-1.56|0.333
91762073|NCT01371734|183415066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.923|TWO_SIDED|95.0|-0.29|0.32|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||0.32|-0.29|0.923
91762074|NCT01371734|183415066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.161||||0.302|TWO_SIDED|95.0|-0.14|0.47|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||0.47|-0.14|0.302
91762075|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.729|||||||Cochran-Mantel-Haenszel|||Week 1||||0.729
91762076|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.756|||||||Cochran-Mantel-Haenszel|||Week 1||||0.756
91762077|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.765|||||||Cochran-Mantel-Haenszel|||Week 2||||0.765
91762078|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 2||||0.475
91762079|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.31|||||||Cochran-Mantel-Haenszel|||Week 3||||0.310
91762080|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared, Corrected|||Week 3||||0.105
91762081|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.254|||||||Cochran-Mantel-Haenszel|||Week 4||||0.254
91762082|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.887|||||||Cochran-Mantel-Haenszel|||Week 4||||0.887
91762083|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 6||||0.475
91762084|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 6||||0.407
91762085|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.696|||||||Cochran-Mantel-Haenszel|||Week 8||||0.696
91762086|NCT01371734|183415067|SUPERIORITY_OR_OTHER|||||||0.462|||||||Cochran-Mantel-Haenszel|||Week 8||||0.462
91762087|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.806||||0.633|TWO_SIDED|95.0|0.333|1.951|||Regression, Logistic|||Week 1||1.951|0.333|0.633
91762088|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.172|TWO_SIDED|95.0|0.245|1.285|||Regression, Logistic|||Week 1||1.285|0.245|0.172
91762089|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.939||||0.826|TWO_SIDED|95.0|0.536|1.644|||Regression, Logistic|||Week 2||1.644|0.536|0.826
91762090|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.599|TWO_SIDED|95.0|0.489|1.511|||Regression, Logistic|||Week 2||1.511|0.489|0.599
91762091|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.713||||0.248|TWO_SIDED|95.0|0.402|1.265|||Regression, Logistic|||Week 3||1.265|0.402|0.248
91762092|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.564||||0.048|TWO_SIDED|95.0|0.32|0.995|||Regression, Logistic|||Week 3||0.995|0.320|0.048
91762093|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.21|TWO_SIDED|95.0|0.412|1.216|||Regression, Logistic|||Week 4||1.216|0.412|0.210
91762094|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.964||||0.893|TWO_SIDED|95.0|0.564|1.646|||Regression, Logistic|||Week 4||1.646|0.564|0.893
91762095|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.714||||0.228|TWO_SIDED|95.0|0.413|1.235|||Regression, Logistic|||Week 6||1.235|0.413|0.228
91762096|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.751|TWO_SIDED|95.0|0.531|1.579|||Regression, Logistic|||Week 6||1.579|0.531|0.751
91762097|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.974||||0.925|TWO_SIDED|95.0|0.561|1.689|||Regression, Logistic|||Week 8||1.689|0.561|0.925
91762098|NCT01371734|183415068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.764||||0.342|TWO_SIDED|95.0|0.438|1.331|||Regression, Logistic|||Week 8||1.331|0.438|0.342
91762099|NCT00145574|183415071|SUPERIORITY_OR_OTHER|||||||0.1122|||||||ANCOVA|||The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%.||||0.1122
91762100|NCT00145574|183415071|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91762101|NCT00145574|183415072|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||ANCOVA|||||||0.5260
91762102|NCT00145574|183415072|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||ANCOVA|||||||0.0085
91762103|NCT00145574|183415073|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91762104|NCT00145574|183415073|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
91762105|NCT00145574|183415074|SUPERIORITY_OR_OTHER|||||||0.0155||95.0|||||ANCOVA|||||||0.0155
91762106|NCT00145574|183415074|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91762107|NCT00145574|183415075|SUPERIORITY_OR_OTHER|||||||0.3482||95.0|||||ANCOVA|||||||0.3482
91762108|NCT00145574|183415075|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
91762109|NCT00145574|183415076|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|||||||0.0002
91762110|NCT00145574|183415076|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91762111|NCT00145574|183415077|SUPERIORITY_OR_OTHER|||||||0.7433||95.0|||||ANCOVA|||||||0.7433
91762112|NCT00145574|183415077|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|||||||0.0003
91762113|NCT00621140|183415085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.85|-0.53|||ANCOVA|||Linagliptin vs. Placebo||-0.53|-0.85|<0.0001
91535989|NCT00930813|182950788|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.||||0.016
91535990|NCT04889118|182950851|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.55||||0.0013|TWO_SIDED|95.0|0.37|0.81||One-sided p-value based on log-rank test.|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||0.81|0.37|0.0013
91535991|NCT04889118|182950852|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|Hazard Ratio (HR)|0.93||||0.3728|TWO_SIDED|95.0|0.58|1.48||One-sided p-value based on log-rank test|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.58|0.3728
91535992|NCT00601640|182950861|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
91535993|NCT01456936|182950865|SUPERIORITY_OR_OTHER|||||||0.0652||||||An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.|Regression, Linear|A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis.||The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.||||0.0652
91535994|NCT01456936|182950866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.28|||||TWO_SIDED|95.0|-2.4|-0.15|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model.|Non-psychiatric cohort||-0.15|-2.40|
91535995|NCT01456936|182950866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08|||||TWO_SIDED|95.0|-1.37|1.21|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Non-psychiatric cohort||1.21|-1.37|
91535996|NCT01456936|182950866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21|||||TWO_SIDED|95.0|-1.54|1.12|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Non-psychiatric cohort||1.12|-1.54|
91535997|NCT01456936|182950866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.59|||||TWO_SIDED|95.0|-0.42|3.59|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model|Psychiatric cohort||3.59|-0.42|
91535998|NCT01456936|182950866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.78|||||TWO_SIDED|95.0|-0.24|3.81|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Psychiatric cohort||3.81|-0.24|
91762114|NCT00621140|183415086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.58|-0.34|||ANCOVA|||Linagliptin vs. Placebo||-0.34|-0.58|<0.0001
91535999|NCT01456936|182950866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.37|||||TWO_SIDED|95.0|-1.53|2.26|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Psychiatric cohort||2.26|-1.53|
91536000|NCT01456936|182950881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|3.2|5.0||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||5.00|3.20|<0.0001
91536001|NCT01456936|182950881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.8|2.85||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.85|1.80|<0.0001
91536002|NCT01456936|182950881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.83|2.9||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.90|1.83|<0.0001
91536003|NCT01456936|182950882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|2.56|4.11||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||4.11|2.56|<0.0001
91536004|NCT01456936|182950882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.46|2.39||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.39|1.46|<0.0001
91762115|NCT00621140|183415087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.76|-0.47|||ANCOVA|||Linagliptin vs. Placebo||-0.47|-0.76|<0.0001
91762116|NCT00621140|183415088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.82|-0.49|||ANCOVA|||Linagliptin vs. Placebo||-0.49|-0.82|<0.0001
91762117|NCT00621140|183415089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.31|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001||95.0|-30.37|-16.26|||ANCOVA|||Linagliptin vs. Placebo||-16.26|-30.37|<0.0001
91762118|NCT00621140|183415090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001||95.0|-23.11|-12.08|||ANCOVA|||Linagliptin vs. Placebo||-12.08|-23.11|<0.0001
91762119|NCT00621140|183415091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.98|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001||95.0|-27.21|-14.75|||ANCOVA|||Linagliptin vs. Placebo||-14.75|-27.21|<0.0001
91536005|NCT01456936|182950882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.56|2.55||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.55|1.56|<0.0001
91536006|NCT01456936|182950883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61|||<|0.0001|TWO_SIDED|95.0|3.07|4.24||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||4.24|3.07|<0.0001
91536007|NCT01456936|182950883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.75|2.45||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.45|1.75|<0.0001
91536008|NCT01456936|182950883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.82|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.54|1.82|<0.0001
91536009|NCT01456936|182950884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|2.33|3.83||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.83|2.33|<0.0001
91536010|NCT01456936|182950884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.54|2.59||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.59|1.54|<0.0001
91536011|NCT01456936|182950884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.51|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.54|1.51|<0.0001
91536012|NCT01456936|182950885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.9|3.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.29|1.90|<0.0001
91536013|NCT01456936|182950885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|||<|0.0001|TWO_SIDED|95.0|1.33|2.36||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.36|1.33|<0.0001
91536014|NCT01456936|182950885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.24|2.2||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.20|1.24|<0.0001
91536015|NCT01456936|182950886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.0001|TWO_SIDED|95.0|2.28|3.3||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||3.30|2.28|<0.0001
91536016|NCT01456936|182950886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89|||<|0.0001|TWO_SIDED|95.0|1.56|2.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.29|1.56|<0.0001
91536017|NCT01456936|182950886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.49|2.19||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.19|1.49|<0.0001
91536018|NCT00906698|182950899|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|126.2|||||TWO_SIDED|90.0|69.549|229.012|||ANOVA|||||229.012|69.549|
91536019|NCT00906698|182950900|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|75.58|||||TWO_SIDED|90.0|65.037|87.837|||ANOVA|||||87.837|65.037|
91536020|NCT00906698|182950901|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|132.8|||||TWO_SIDED|90.0|72.305|243.917|||ANOVA|||||243.917|72.305|
91536021|NCT00906698|182950902|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.8|||||TWO_SIDED|90.0|61.156|114.823|||ANOVA|||||114.823|61.156|
91536022|NCT00906698|182950905|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|90.21|||||TWO_SIDED|90.0|76.071|106.978|||ANOVA|||||106.978|76.071|
91536023|NCT00906698|182950906|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|76.75|||||TWO_SIDED|90.0|56.71|103.871|||ANOVA|||||103.871|56.710|
91536024|NCT00906698|182950907|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.86|||||TWO_SIDED|95.0|66.369|105.966|||ANOVA|||||105.966|66.369|
91536025|NCT00906698|182950908|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|81.7|||||TWO_SIDED|90.0|60.47|110.369|||ANOVA|||||110.369|60.470|
91536026|NCT03879642|182950911|SUPERIORITY||partial eta squared|0.117|||||TWO_SIDED||||||ANOVA|||||||
91536027|NCT03879642|182950912|SUPERIORITY||partial eta squared|0.005|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91536028|NCT00404079|182950947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|STANDARD_DEVIATION|4.0||0.05|||||||Mixed Models Analysis|||Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models||||0.05
91762120|NCT00621140|183415092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.36|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.05|-13.68|||ANCOVA|||Linagliptin vs. Placebo||-13.68|-27.05|<0.0001
91762121|NCT00621140|183415093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.869||||0.0006||95.0|1.575|5.225|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.225|1.575|0.0006
91762122|NCT00621140|183415095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.436||||0.0323||95.0|1.078|5.507|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.507|1.078|0.0323
91762123|NCT00621140|183415097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.243|||<|0.0001||95.0|2.665|6.755|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||6.755|2.665|<0.0001
91762124|NCT00621140|183415098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.38|STANDARD_DEVIATION|12.05|<|0.0001||95.0|-82.33|-34.43|||ANCOVA|||Linagliptin vs. Placebo||-34.43|-82.33|<0.0001
91762125|NCT02669121|183415128|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|99.99|-13.181|0.997|||||||The vaccine efficacy was met if lower bound of confidence interval (CI) for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the Cox proportional hazard (PH) model. The 99.99% CI for the VE was obtained by taking 1 minus the 99.99% CI of the hazard ratio from the PH model.|0.997|-13.181|
91762126|NCT02669121|183415129|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.01|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95.01% CI for the VE was obtained by taking 1 minus the 95.01% CI of the hazard ratio from the PH model.|0.816|0.208|
91762127|NCT02669121|183415130|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.0|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.816|0.208|
91762128|NCT02669121|183415131|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|-0.711|0.977|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.977|-0.711|
91762129|NCT03216746|183415132|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91762130|NCT03637517|183415176|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.926||||0.4847|TWO_SIDED|90.0|0.771|1.113|||ANOVA|||||1.113|0.771|0.4847
91762131|NCT03637517|183415176|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.79||||0.037|TWO_SIDED|90.0|0.658|0.95|||ANOVA|||||0.950|0.658|0.0370
91762132|NCT03637517|183415177|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.899||||0.1135|TWO_SIDED|90.0|0.805|1.004|||ANOVA|||||1.004|0.805|0.1135
91762133|NCT03637517|183415177|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.175||||0.0192|TWO_SIDED|90.0|1.051|1.312|||ANOVA|||||1.312|1.051|0.0192
91762134|NCT03637517|183415178|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.898||||0.1759|TWO_SIDED|90.0|0.787|1.024|||ANOVA||Regimen B to A|||1.024|0.787|0.1759
91762135|NCT03637517|183415178|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.172||||0.0496|TWO_SIDED|90.0|1.027|1.338|||ANOVA||Regimen C to B|||1.338|1.027|0.0496
91536029|NCT00404079|182950947|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|||||||0.05
91762136|NCT03637517|183415179|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|-0.2857|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|-3.4313|2.8599||||||||2.8599|-3.4313|
91762137|NCT03637517|183415179|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|9.3571|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|6.2115|12.5028|||||Regimen C to B|||12.5028|6.2115|
91762138|NCT03637517|183415181|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.866||||0.1745|TWO_SIDED|90.0|0.727|1.032|||ANOVA|||(ANOVA) will be performed for Tmax, the terminal phase elimination rate constant β, and the natural logarithms of Cmax, AUCt, AUC168, AUCinf, and C168. The model will include the effects for regimen. For the tests on regimen effects, the denominator sum of squares will be the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen will be compared to the respective reference regimen by a test with a significance level of 0.05.||1.032|0.727|0.1745
91762139|NCT03637517|183415181|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.185||||0.1105|TWO_SIDED|90.0|0.995|1.411||For tests on regimen effects, the denominator sum of squares is the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen is compared to the respective reference regimen by a test with a significance level of 0.05.|ANOVA|||||1.411|0.995|0.1105
91762140|NCT03637517|183415182|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|0.901||||0.31|TWO_SIDED|90.0|0.759|1.069|||ANOVA|||||1.069|0.759|0.3100
91762141|NCT03637517|183415182|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|1.156||||0.1619|TWO_SIDED|90.0|0.974|1.371|||ANOVA|||||1.371|0.974|0.1619
91762142|NCT00118430|183415243|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||<0.001
91762143|NCT00118430|183415244|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||< 0.001
91762144|NCT00118430|183415245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91762145|NCT00118430|183415246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Poisson|||||||<0.001
91762146|NCT00534976|183415247|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.65||||0.02||95.0|||||ANOVA||Montelukast minus placebo|||||0.020
91762147|NCT00534976|183415248|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.33||||0.005||95.0|||||ANOVA||Montelukast minus placebo|||||0.005
91762148|NCT00534976|183415249|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-120.86||||0.022||95.0|||||ANOVA||Montelukast minus placebo|||||0.022
91762149|NCT00534976|183415250|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-122.82||||0.013||95.0|||||ANOVA||Montelukast minus placebo|||||0.013
91762150|NCT00534976|183415251|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-8.27||||0.064||95.0|||||ANOVA||Montelukast minus placebo|||||0.064
91762151|NCT00534976|183415252|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-7.06||||0.054||95.0|||||ANOVA||Montelukast minus Placebo|||||0.054
91762152|NCT00534976|183415253|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-1.6||||1||95.0||||P-value provided is for comparison between the two proportions: Montelukast versus placebo.|McNemar||Montelukast minus placebo|||||1.000
91762153|NCT00534976|183415254|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-3.2||||||95.0|||||||Montelukast minus placebo|||||
91762154|NCT00264537|183415296|SUPERIORITY_OR_OTHER|||||||0.053||||||A positive test is concluded if there is a significant difference between golimumab+MTX and placebo+MTX and at least one of the pair-wise comparisons at a 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Group 1 vs combined Groups 3 and 4. The sample size of 150 patients per treatment group will provide \>98% power to detect a difference in ACR 50 response between treatment groups at alpha=0.05, assuming 50% of patients with screening C-reactive protein (CRP)\<1.5mg/dL, and the difference in ACR 50 response of 15-20% in patients with screening CRP\<1.5mg/dL and 20-25% in subjects with screening CRP\>=1.5mg/dL, between Groups 1 vs 3 or 4||||0.053
91762155|NCT00264537|183415296|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 3.||||0.042
91762156|NCT00264537|183415296|SUPERIORITY_OR_OTHER|||||||0.177|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 4.||||0.177
91762157|NCT00264537|183415296|NON_INFERIORITY_OR_EQUIVALENCE|This sample size (150 patients per treatment group) will provide approximately 85% power to claim non-inferiority of golimumab alone (Group 2) compared with MTX alone (Group 1) at alpha= 0.05 using a one-sided equivalence test assuming the proportion of golimumab alone (Group 2) treated patients with ACR 50 response is not less than 10% compared with proportion of patients with ACR 50 response in MTX alone (Group 1) treated group.|Difference in ACR 50 Response Rate(%)|3.3||||0.521||95.0|-6.8||The upper bound of 95% CI was not produced because it was not relevant to the pre-specified analysis||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)|The positive difference indicates in favor of golimumab+placebo compared to placebo+MTX; The upper bound of CI is not applicable.|"Null hypothesis: Group 2 is inferior to Group 1. Noninferiority of golimumab will be demonstrated if the lower bound of the 2-sided 95% CI is above -10%. The 10% non-inferiority margin was chosen because this difference is not clinically admissible. Under the above noted assumed response rates, this corresponds to preservation of at least 70% \[(33% - 10%)/33%\*100\] of the expected MTX benefit."|||-6.8|0.521
91762158|NCT00264537|183415297|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.011
91762159|NCT00264537|183415297|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
91762160|NCT00264537|183415297|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
91762161|NCT00264537|183415297|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.677
91762162|NCT00264537|183415298|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.178
91762163|NCT00264537|183415298|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.250
91762164|NCT00264537|183415298|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.240
91762165|NCT00264537|183415298|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.339
91762166|NCT00264537|183415299|SUPERIORITY_OR_OTHER|||||||0.006||||||If this test is significant, a pairwise comparison between Group 3 and Group 1, and between Group 4 and Group 1 will be performed|ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; ≥ 1.5 mg/dL)||Null Hypothesis: No difference in vdH-S score comparing Groups 1 vs Groups 3 and 4 combined. The sample size of 150 subjects in each treatment group (Group 1, Group 3, Group 4) will provide \> 95% power to detect a difference in the vdH-S score between treatment groups using a 2-sided t-test on van der Waerden normal scores of change from baseline in vdH-S score at α = 0.05, assuming a mean change from baseline in vdH-S score of 3.5 for the placebo group and 1 for Groups 3 and 4.||||0.006
91762167|NCT00264537|183415299|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 3.||||0.015
91762168|NCT00264537|183415299|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 4.||||0.025
91762169|NCT00264537|183415300|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.003
91762170|NCT00264537|183415300|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.010
91762171|NCT00264537|183415300|SUPERIORITY_OR_OTHER|||||||0.014|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.014
91762172|NCT00264537|183415300|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.545
91762173|NCT00997594|183415304|NON_INFERIORITY_OR_EQUIVALENCE|Just a comparison of the percentage of hypertension between the 2 patient groups.|||||<|0.05||95.0|||||Chi-squared, Corrected|||||||<0.05
91762174|NCT00806988|183415334|OTHER|An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.||||0.61
91762175|NCT00806988|183415335|OTHER|||||||0.83|||||||Chi-squared|||||||0.83
91762176|NCT04775953|183415342|SUPERIORITY|For participants with the same DOOR, quality-of-life (QoL) was used as a tiebreaker and was calculated as change from baseline QoL to Day 70 QoL score, as assessed by questions from the PROMIS physical function item bank (PROMIS Item Bank v2.0, short form 6b) on the Antibacterial Resistance Leadership Group (ARLG) Bloodstream Infection QoL Measure. Superiority of dalbavancin is concluded if the lower bound of the 95% confidence interval for the DOOR probability is greater than 50%.|Pr(Better DOOR in dalbavancin arm)|47.7|||||TWO_SIDED|95.0|39.84|55.68|||||The DOOR probability is calculated using the Wilcoxon-Mann-Whitney statistic corrected for ties.|Null Hypothesis: Probability that a participant in the dalbavancin arm has a better DOOR than a participant in the standard of care arm plus one-half the probability of equal DOOR is 50% (i.e., no difference in DOOR).||55.68|39.84|
91762177|NCT04775953|183415343|NON_INFERIORITY|The non-inferiority margin is -20%. Non-inferiority of dalbavancin is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical efficacy is greater than -20%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-12.0|14.0|||||Difference in proportions of clinical efficacy for dalbavancin compared to standard of care and 95% confidence interval obtained from a linear regression model.|Null Hypothesis: The proportion of clinical efficacy in the dalbavancin arm minus the proportion of clinical efficacy in the standard of care arm is -20%.||14|-12|
91762178|NCT01980095|183415407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||One-sample Z-test, RHB-105 subjects only|||||||0.001
91762179|NCT00856544|183415420|SUPERIORITY_OR_OTHER||Percent difference|27.04|||<|0.0001|TWO_SIDED|95.0|17.94|36.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||36.13|17.94|<0.0001
91536030|NCT01879371|182950950|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|107.85|||||TWO_SIDED|90.0|105.334|110.431|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|"The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect.~The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested."||110.431|105.334|
91762180|NCT00856544|183415420|SUPERIORITY_OR_OTHER||Percent Difference|21.52|||<|0.0001|TWO_SIDED|95.0|12.39|30.65||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||30.65|12.39|<0.0001
91762181|NCT00856544|183415421|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.26||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.26|-0.44|<0.0001
91762182|NCT00856544|183415421|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.16|-0.35|<0.0001
91536031|NCT01879371|182950950|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.48|||||TWO_SIDED|90.0|107.072|111.936|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.936|107.072|
91762183|NCT00856544|183415422|SUPERIORITY_OR_OTHER||Percent difference|10.63|||<|0.0001|TWO_SIDED|95.0|5.8|15.45||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.45|5.80|<0.0001
91762184|NCT00856544|183415422|SUPERIORITY_OR_OTHER||Percent difference|6.42||||0.0038|TWO_SIDED|95.0|2.07|10.77||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.77|2.07|0.0038
91536032|NCT01879371|182950951|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|99.65|||||TWO_SIDED|90.0|93.874|105.776|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||105.776|93.874|
91762185|NCT04808141|183415473|EQUIVALENCE|For a power of 80% and a two-sided 0.05 significance level, we calculated that 102 individuals would be necessary to detect a 10-point difference between the two groups. To guarantee that the study was adequately powered to detect equivalence, a posteriori analysis was conducted using the Two One-Sided Test (TOST) methodology (simulation-based power analysis).|Median Difference (Net)|-0.55||||0.412|TWO_SIDED|95.0|-2.42|5.81||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||5.81|-2.42|0.412
91536033|NCT01879371|182950951|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|70.42|||||TWO_SIDED|90.0|67.087|73.928|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||73.928|67.087|
91536034|NCT01879371|182950952|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|106.5|||||TWO_SIDED|90.0|104.05|109.004|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||109.004|104.050|
91536035|NCT01879371|182950952|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|108.59|||||TWO_SIDED|90.0|106.185|111.054|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.054|106.185|
91536036|NCT00580801|182950967|SUPERIORITY_OR_OTHER||Least square mean ratio|0.98||||||90.0|0.54|1.78|||||Day 1: The least square (LS) means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.78|0.54|
91536037|NCT00580801|182950967|SUPERIORITY_OR_OTHER||Least square mean ratio|1.33||||||90.0|1.03|1.72|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|1.03|
91536038|NCT00580801|182950968|SUPERIORITY_OR_OTHER||Least square mean ratio|1.0||||||90.0|0.58|1.72|||||Day 1: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|0.58|
91536039|NCT00580801|182950968|SUPERIORITY_OR_OTHER||Least square mean ratio|1.32||||||90.0|1.05|1.66|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.66|1.05|
91536040|NCT00580801|182950969|SUPERIORITY_OR_OTHER||Least square mean ratio|1.43||||||90.0|1.02|2.02|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||2.02|1.02|
91536041|NCT00580801|182950970|SUPERIORITY_OR_OTHER||Least square mean ratio|1.24||||||90.0|0.88|1.74|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.74|0.88|
91536042|NCT05576051|182950988|OTHER|||||||0.278|||||||Mixed model linear regression|Mixed model linear regression with propensity-score matched pairs as the random effect.||||||0.278
91536043|NCT05576051|182950989|OTHER|||||||0.131|||||||Mixed model linear regression|Mixed model linear regression with propensity-score matched pairs as the random effect.||||||0.131
91536044|NCT05576051|182950990|OTHER|||||||0.987|||||||Mixed model linear regression|Mixed model linear regression with propensity-score matched pairs as the random effect.||||||0.987
91536045|NCT02107014|182951008|SUPERIORITY_OR_OTHER|||||||0.576|||||||Mixed Models Analysis|||||||.576
91536046|NCT02107014|182951009|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.010
91536047|NCT02107014|182951010|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||.008
91536048|NCT02107014|182951011|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||||||.015
91536049|NCT02107014|182951012|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||.007
91536050|NCT02107014|182951013|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||.016
91536051|NCT02107014|182951014|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91536052|NCT02107014|182951015|SUPERIORITY_OR_OTHER|||||||0.212|||||||Mixed Models Analysis|||||||0.212
91536053|NCT02107014|182951018|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||0.008
91536054|NCT02107014|182951019|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91536055|NCT02107014|182951020|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91536056|NCT02107014|182951021|SUPERIORITY_OR_OTHER|||||||0.047|||||||Mixed Models Analysis|||||||0.047
91536057|NCT02107014|182951022|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91536058|NCT02107014|182951023|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
91536059|NCT02107014|182951024|SUPERIORITY_OR_OTHER|||||||0.191|||||||Mixed Models Analysis|||||||0.191
91536060|NCT02107014|182951025|SUPERIORITY_OR_OTHER|||||||0.088|||||||Mixed Models Analysis|||||||0.088
91536061|NCT02107014|182951026|SUPERIORITY_OR_OTHER|||||||0.478|||||||Mixed Models Analysis|||||||0.478
91536062|NCT02107014|182951029|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
91536063|NCT02107014|182951030|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.025
91536064|NCT02107014|182951031|SUPERIORITY_OR_OTHER|||||||0.012|||||||Mixed Models Analysis|||||||0.012
91536065|NCT02107014|182951032|SUPERIORITY_OR_OTHER|||||||0.426|||||||Mixed Models Analysis|||||||0.426
91536066|NCT02107014|182951033|SUPERIORITY_OR_OTHER|||||||0.042|||||||Mixed Models Analysis|||||||0.042
91762186|NCT04808141|183415473|EQUIVALENCE||Odds Ratio (OR)|0.926||||0.849|TWO_SIDED|95.0|0.42|2.05||The threshold for statistical analysis was set at 0.05.|Regression, Logistic|||||2.05|0.42|0.849
91536067|NCT02107014|182951034|SUPERIORITY_OR_OTHER|||||||0.708|||||||Mixed Models Analysis|||||||0.708
91536068|NCT02107014|182951035|SUPERIORITY_OR_OTHER|||||||0.558|||||||Mixed Models Analysis|||||||0.558
91536069|NCT02107014|182951036|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
91536070|NCT02107014|182951037|SUPERIORITY_OR_OTHER|||||||0.655|||||||Mixed Models Analysis|||||||0.655
91536071|NCT02107014|182951038|SUPERIORITY_OR_OTHER|||||||0.248|||||||Mixed Models Analysis|||||||0.248
91536072|NCT02107014|182951039|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|||||||0.128
91536073|NCT02107014|182951040|SUPERIORITY_OR_OTHER|||||||0.065|||||||Mixed Models Analysis|||||||0.065
91536074|NCT02107014|182951041|SUPERIORITY_OR_OTHER|||||||0.962|||||||Mixed Models Analysis|||||||0.962
91536075|NCT02107014|182951042|SUPERIORITY_OR_OTHER|||||||0.402|||||||Mixed Models Analysis|||||||0.402
91536076|NCT02107014|182951043|SUPERIORITY_OR_OTHER|||||||0.201|||||||Mixed Models Analysis|||||||0.201
91536077|NCT02107014|182951044|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
91536078|NCT02107014|182951045|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|||||||0.006
91536079|NCT02107014|182951046|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91536080|NCT02107014|182951047|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
91536081|NCT02107014|182951048|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|||||||0.032
91536082|NCT02107014|182951049|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91536083|NCT02107014|182951051|SUPERIORITY_OR_OTHER|||||||0.508|||||||Mixed Models Analysis|||||||0.508
91536084|NCT02107014|182951052|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
91536085|NCT02107014|182951053|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|||||||0.326
91536086|NCT02107014|182951054|SUPERIORITY_OR_OTHER|||||||0.753|||||||Mixed Models Analysis|||||||0.753
91536087|NCT02107014|182951055|SUPERIORITY_OR_OTHER|||||||0.067|||||||Mixed Models Analysis|||||||0.067
91536088|NCT02107014|182951056|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.080
91536089|NCT02107014|182951057|SUPERIORITY_OR_OTHER|||||||0.639|||||||Mixed Models Analysis|||||||0.639
91762187|NCT04808141|183415474|EQUIVALENCE||Median Difference (Net)|0.3||||0.666|TWO_SIDED|95.0|-0.71|1.1||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||1.10|-0.71|0.666
91536090|NCT02107014|182951060|SUPERIORITY_OR_OTHER|||||||0.945|||||||Mixed Models Analysis|||||||0.945
91536091|NCT02107014|182951061|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
91536092|NCT02107014|182951062|SUPERIORITY_OR_OTHER|||||||0.281|||||||Mixed Models Analysis|||||||0.281
91536093|NCT02107014|182951063|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.030
91536094|NCT02107014|182951064|SUPERIORITY_OR_OTHER|||||||0.948|||||||Mixed Models Analysis|||||||0.948
91536095|NCT02107014|182951065|SUPERIORITY_OR_OTHER|||||||0.61|||||||Mixed Models Analysis|||||||0.610
91536096|NCT02107014|182951066|SUPERIORITY_OR_OTHER|||||||0.893|||||||Mixed Models Analysis|||||||0.893
91536097|NCT02107014|182951067|SUPERIORITY_OR_OTHER|||||||0.041|||||||Mixed Models Analysis|||||||0.041
91536098|NCT02107014|182951070|SUPERIORITY_OR_OTHER|||||||0.967|||||||Mixed Models Analysis|||||||0.967
91536099|NCT02107014|182951071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91536100|NCT02107014|182951072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91536101|NCT02512042|182951113|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 (hours 0, before the morning drop) at the Day 14 visit should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.36|||||TWO_SIDED|95.0|-0.69|-0.03||||||||-0.03|-0.69|
91536102|NCT02512042|182951113|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/- 1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.43|0.22||||||||0.22|-0.43|
91536103|NCT02512042|182951113|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 14 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.71|-0.09||||||||-0.09|-0.71|
91536104|NCT02512042|182951113|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population|Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.5|0.13||||||||0.13|-0.50|
91536105|NCT01467700|182951118|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.28||0.518|TWO_SIDED|98.0|-2.9|3.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.1|-2.9|0.518
91762188|NCT04808141|183415475|EQUIVALENCE||Median Difference (Net)|-2.62||||0.122|TWO_SIDED|95.0|-14.87|4.8||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust test on the medians||||4.80|-14.87|0.122
91762189|NCT04808141|183415476|EQUIVALENCE||Median Difference (Net)|3.32||||0.788|TWO_SIDED|95.0|-3.11|5.9||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||5.90|-3.11|0.788
91762190|NCT04808141|183415477|EQUIVALENCE||Odds Ratio (OR)|0.92||||0.081|TWO_SIDED|95.0|0.0|1.23||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming analgesics at 8 weeks using the CG as a reference.||||1.23|0.00|0.081
91762191|NCT04808141|183415477|EQUIVALENCE||Odds Ratio (OR)|0.26||||0.985|TWO_SIDED|95.0|0.0|1.71||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming opioids at 8 weeks using the CG as a reference.||||1.71|0.00|0.985
91762192|NCT04808141|183415478|EQUIVALENCE||Median Difference (Net)|-0.42||||0.871|TWO_SIDED|95.0|-2.1|1.78||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.78|-2.10|0.871
91762193|NCT04808141|183415479|EQUIVALENCE||Median Difference (Final Values)|0.43||||0.36|TWO_SIDED|95.0|-0.59|1.59||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.59|-0.59|0.360
91762194|NCT04808141|183415480|EQUIVALENCE||Mean Difference (Final Values)|0.09||||0.837|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||0.837
91762195|NCT04808141|183415481|EQUIVALENCE||Z-score|-1.28||||0.886|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Ordinal Regression|||||||0.886
91762196|NCT04808141|183415482|EQUIVALENCE||Median Difference (Net)|1.33||||0.095|TWO_SIDED|95.0|-2.2|2.46||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||2.46|-2.20|0.095
91762197|NCT04808141|183415484|EQUIVALENCE||Mean Difference (Final Values)|65.8||||0.662|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.662
91762198|NCT04808141|183415485|EQUIVALENCE||Median Difference (Net)|-1.97||||0.246|TWO_SIDED|95.0|-12.69|3.33|||Quantile mixed-effects model|Robust method on the medians||||3.33|-12.69|0.246
91762199|NCT04808141|183415486|EQUIVALENCE||Median Difference (Net)|-0.73||||0.408|TWO_SIDED|95.0|-6.5|2.69||the threshold for statistical significance was set at 0.05|Quantile mixed-effects model|Robust method on the medians.||||2.69|-6.50|0.408
91762200|NCT04808141|183415487|EQUIVALENCE||Median Difference (Net)|0.35||||0.65|TWO_SIDED|95.0|-6.22|9.87||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||9.87|-6.22|0.650
91762201|NCT04808141|183415488|EQUIVALENCE||Difference in proportions|18.6||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
91517826|NCT01106833|182910126|SUPERIORITY|||||||0.309||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.309
91762202|NCT00394706|183415495|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||0.59|TWO_SIDED|95.0|-1.1|0.7||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|Mixed Models Analysis||Estimate of the rate of MRS \<= 3 in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of MRS \<=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.||0.7|-1.1|0.59
91762203|NCT00394706|183415495|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.71|TWO_SIDED|95.0|-1.1|0.8||To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)|t-test, 2 sided||Estimate of the rate of MRS \<= 3 in the active ITD arm minus the rate in the Sham ITD arm.|Comparison of the rates of MRS \<=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.||0.8|-1.1|0.71
91762204|NCT00394706|183415496|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.92|TWO_SIDED|95.0|-1.2|1.1||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|GEE||Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.||1.1|-1.2|0.92
91762205|NCT00394706|183415496|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.99|TWO_SIDED|95.0|-1.2|1.1|||t-test, 2 sided||Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.|Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.||1.1|-1.2|0.99
91762206|NCT00394706|183415497|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.2|0.34|||||Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.34|-0.20|
91762207|NCT00394706|183415497|SUPERIORITY||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.17|0.44|||||Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.44|-0.17|
91762208|NCT00394706|183415498|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.71|0.83|||||Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.83|-0.71|
91517827|NCT04953390|182910139|OTHER|||||||0.004|||||||ANOVA|||||||0.004
91517828|NCT04953390|182910140|OTHER|||||||0.029|||||||ANOVA|||||||.029
91762209|NCT00394706|183415498|SUPERIORITY||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.61|0.28|||||Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.28|-1.61|
91762210|NCT00394706|183415499|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.05|||||Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.06|
91762211|NCT00394706|183415499|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.08|0.05|||||Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.08|
91762212|NCT05274269|183415501|SUPERIORITY||LS Mean difference|9.2|||<|0.0001|TWO_SIDED|95.0|7.2|11.3|||Mixed Models for Repeated Measures|||||11.3|7.2|< 0.0001
91762213|NCT05274269|183415502|SUPERIORITY||LS Mean difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.5|||Mixed Models for Repeated Measures|||||-24.5|-32.1|< 0.0001
91762214|NCT05274269|183415503|SUPERIORITY||LS Mean difference|19.5|||<|0.0001|TWO_SIDED|95.0|15.5|23.5|||Mixed Models for Repeated Measures|||||23.5|15.5|< 0.0001
91762215|NCT05274269|183415504|SUPERIORITY||LS Mean difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.24|0.69|||Mixed Models for Repeated Measures|||||0.69|0.24|< 0.0001
91762216|NCT05274269|183415505|SUPERIORITY||LS Mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.6|1.9|||Mixed Models for Repeated Measures|||||1.9|0.6|< 0.0001
91762217|NCT00709618|183415530|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.4|55.4|||||The estimated value respresents the percentage of participants with a complete response or a partial response.|||55.4|26.4|
91762218|NCT04759157|183415554|SUPERIORITY|||||||0.3|||||||mixed model|||||||.30
91762219|NCT04759157|183415555|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.05||0.206|TWO_SIDED|95.0|-6.63|1.43|||Mixed Models Analysis||This estimate is comparing intervention to control from baseline to 3 month for both patients and partners|We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.||1.43|-6.63|.206
91762220|NCT01746225|183415571|SUPERIORITY|||||||0.12||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||0.12
91762221|NCT01746225|183415571|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.03
91762222|NCT01746225|183415571|SUPERIORITY|||||||0.2||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.20
91762223|NCT00595478|183415577|SUPERIORITY||Odds Ratio (OR)|0.8||||0.66|TWO_SIDED|95.0|0.29|2.18|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0 ETG-positive samples for MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.18|0.29|0.66
91762224|NCT00595478|183415577|SUPERIORITY||mean ratio|0.93||||0.61|TWO_SIDED|95.0|0.71|1.22|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for number of ETG-positive samples, if \>0 ETG-positive samples: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||1.22|0.71|0.61
91762225|NCT00595478|183415578|SUPERIORITY||Odds Ratio (OR)|0.82||||0.74|TWO_SIDED|95.0|0.26|2.62|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0% days using alcohol during the 36 week follow-up period: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.62|0.26|0.74
91762226|NCT00595478|183415578|SUPERIORITY||mean ratio|0.74||||0.007|TWO_SIDED|95.0|0.59|0.92|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||.92|.59|0.007
91762227|NCT02708355|183415588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.028||||0.0442|TWO_SIDED|95.0|1.001|1.055|||Regression, Logistic|||Association between percentage of time with intragastric pH\>4 and relief of 24 -hour heartburn was assessed using logistic regression model with relief of 24- hour heartburn at Day 14 as dependent variable and change in percentage of time with intragastric pH\>4 as the independent variable, controlling for age, sex, and body mass index (BMI).||1.055|1.001|0.0442
91762228|NCT04090242|183415589|OTHER||Mean Difference (Final Values)|-0.16||||0.392|TWO_SIDED|95.0|-0.53|0.21||The p value is for the comparison between interventional and control group on change of DES score between baseline and end of study.|Mixed Models Analysis|||With assumptions made in statistical analysis plan, a sample size of 43 subjects per arm had \>80% power to detect a significant difference between the two arms (based on a 2-sided t-test, 95% CI for DES difference between groups). Adding a 10% buffer, planned enrollment was 96 subjects. However, enrollment ended early with about 25 subjects in each arm (56 subjects total). Thus, power decreased to 56%. The study was not sufficiently powered under these conditions.||0.21|-0.53|0.392
91517829|NCT04953390|182910141|OTHER|||||||0.0002|||||||ANOVA|||||||0.0002
91536106|NCT01467700|182951118|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.29||0.979|TWO_SIDED|98.0|-0.4|5.7||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||5.7|-0.4|0.979
91536107|NCT01467700|182951118|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.29||0.4|TWO_SIDED|99.0|-3.7|3.0||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.0|-3.7|0.400
91536108|NCT01467700|182951119|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.22||0.017|TWO_SIDED|98.0|-0.5|9.9||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||9.9|-0.5|0.017
91536109|NCT01467700|182951119|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.25||0.361|TWO_SIDED|98.0|-4.5|6.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||6.1|-4.5|0.361
91536110|NCT01467700|182951119|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.23||0.002|TWO_SIDED|99.0|0.6|12.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||12.1|0.6|0.002
91536111|NCT05822440|182951244|OTHER||Ratio of Adjusted Geometric Means|124.35|||||TWO_SIDED|90.0|100.22|154.29||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||154.29|100.22|
91536112|NCT05822440|182951245|OTHER||Ratio of Adjusted Geometric Means|212.83||||||90.0|183.76|246.5||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||246.50|183.76|
91536113|NCT02081391|182951255|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0404|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used SOAM as factors. For participants discontinuing treatment before 12 hours for any other reason than no further need of opioid analgesics or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||0|-0.09|0.0404
91536114|NCT02081391|182951256|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0154|TWO_SIDED|95.0|-0.18|-0.02|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used supplemental opioid analgesic medication (SOAM) as factors. For participants discontinuing treatment before 24 hours for any other reason than no further need of SOAM or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||-0.02|-0.18|0.0154
91762229|NCT00195663|183415633|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment, the second primary analysis of the modified Total Sharp Score was to be performed.|Chi-squared, Corrected|||The study was powered to demonstrate the superiority of adalimumab + MTX combination therapy vs. MTX monotherapy in the proportion of subjects who achieved an ACR50 response at 52 weeks. Power calculations were based on 250 subjects in each group using a chi-squared test with a continuity correction and an alpha = 0.05 significance level. With 250 subjects in each group, a difference of 0.13 in response rates could be detected with 80% power.||||<0.001
91762230|NCT00195663|183415634|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment on the ACR50 response, the second primary analysis of modified TSS would be performed.||||<0.001
91762231|NCT00195663|183415635|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91762232|NCT00195663|183415636|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91762233|NCT00195663|183415637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91762234|NCT00195663|183415638|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91762235|NCT00195663|183415639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91762236|NCT00195663|183415640|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91762237|NCT00195663|183415641|SUPERIORITY_OR_OTHER|||||||0.5402||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5402
91762238|NCT01898013|183415682|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.25||0.02|TWO_SIDED|||||a priori threshold set at 0.05|Mixed Models Analysis|||||||0.02
91762239|NCT01898013|183415683|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.14||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
91762240|NCT01898013|183415684|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.12||0.79|TWO_SIDED||||||Mixed Models Analysis|||||||0.79
91762241|NCT01898013|183415685|SUPERIORITY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
91762242|NCT01898013|183415686|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.63
91762243|NCT01898013|183415687|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.13||0.62|TWO_SIDED||||||Mixed Models Analysis|||||||0.62
91762244|NCT01100775|183415690|SUPERIORITY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Galantamine and Placebo Arms||||0.898
91762245|NCT01100775|183415690|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Galantamine and Placebo Arms||||0.701
91762246|NCT01100775|183415690|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Galantamine and Placebo Arms||||0.16
91762247|NCT01100775|183415690|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms between Galantamine and Placebo Arms||||0.701
91762248|NCT01100775|183415691|SUPERIORITY|||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Galantamine and Placebo Arms||||0.161
91762249|NCT01100775|183415691|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarm Reaction Time between Galantamine and Placebo Arms||||0.028
91762250|NCT01100775|183415691|SUPERIORITY|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Galantamine and Placebo Arms||||0.899
91762251|NCT01100775|183415691|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Galantamine and Placebo Arms||||0.521
91762252|NCT01100775|183415692|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean total amount offered during the trust game between the galantamine and placebo groups||||0.67
91762253|NCT01100775|183415693|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean correct responses between galantamine and placebo||||0.32
91762254|NCT01100775|183415694|SUPERIORITY|||||||0.659|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 1 between galantamine and placebo||||0.659
91762255|NCT01100775|183415694|SUPERIORITY|||||||0.541|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 2 between galantamine and placebo||||0.541
91762256|NCT01100775|183415694|SUPERIORITY|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 3 between galantamine and placebo||||0.838
91762257|NCT01100775|183415695|SUPERIORITY|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||A comparison the mean correct responses between galantamine and placebo||||0.548
91762258|NCT01100775|183415696|SUPERIORITY|||||||0.871|||||||Wilcoxon (Mann-Whitney)|||||||0.871
91762259|NCT01100775|183415697|SUPERIORITY|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect between galantamine and placebo||||0.626
91762260|NCT01100775|183415697|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill between galantamine and placebo||||0.234
91762261|NCT01100775|183415698|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Responses between galantamine and placebo||||0.797
91762262|NCT01100775|183415698|SUPERIORITY|||||||0.669|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Hits between galantamine and placebo||||0.669
91762263|NCT01100775|183415698|SUPERIORITY|||||||0.668|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total False Alarms between galantamine and placebo||||0.668
91762264|NCT04677504|183415707|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.14|0.51|
91762265|NCT04677504|183415708|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8857|TWO_SIDED|95.0|0.64|1.47|||Log Rank|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.47|0.64|0.8857
91762266|NCT04677504|183415712|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.93|2.63|||Regression, Cox|||Quality of Life||2.63|0.93|
91536115|NCT03184428|182951272|OTHER||||||<|0.05|||||||Spearman's rank-order correlation|Bonferroni adjustment in addition||||||<0.05
91762267|NCT04677504|183415712|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.48|1.36|||Regression, Cox|||Physical Function Scale||1.36|0.48|
91762268|NCT04677504|183415712|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.68|1.85|||Regression, Cox|||Role Function Scale||1.85|0.68|
91762269|NCT03182907|183415717|OTHER|The AUC0-inf of bezlotoxumab in Cohort 1 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|Geometric Mean Ratio (GMR)|1.06|||||TWO_SIDED|90.0|0.95|1.18|||||GMR was calculated as the Cohort 1 geometric mean (GM) AUC0-inf / Adult GM AUC0-inf.|||1.18|0.95|
91762270|NCT03182907|183415717|OTHER|The AUC0-inf of bezlotoxumab in Cohort 2 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|GMR|0.82|||||TWO_SIDED|90.0|0.75|0.89|||||GMR was calculated as the Cohort 2 GM AUC0-inf / Adult GM AUC0-inf.|||0.89|0.75|
91762271|NCT03182907|183415718|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% confidence intervals (CIs) in bezlotoxumab versus placebo arms.|Difference in percentage|-5.7|||||TWO_SIDED|95.0|-14.5|7.7||||||||7.7|-14.5|
91762272|NCT03182907|183415719|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% CIs in bezlotoxumab versus placebo arms.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.7|3.5||||||||3.5|-9.7|
91762273|NCT03182907|183415720|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|-3.7|||=|0.5701|TWO_SIDED|95.0|-20.0|8.0|||Stratified Miettinen and Nurminen method|||||8.0|-20.0|= 0.5701
91762274|NCT03182907|183415721|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.8|||=|0.9165|TWO_SIDED|95.0|-11.8|17.6|||Stratified Miettinen and Nurminen method|||||17.6|-11.8|= 0.9165
91762275|NCT03182907|183415722|OTHER|Unstratified Miettinen and Nurminen method was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted Difference|-3.1|||=|0.6542|TWO_SIDED|95.0|-19.9|9.0|||Unstratified Miettinen & Nurminen method|||||9.0|-19.9|= 0.6542
91762276|NCT03182907|183415723|OTHER|Unstratified Miettinen and Nurminen method was used to generate treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.1|||=|0.9873|TWO_SIDED|95.0|-13.0|17.4|||Unstratified Miettinen & Nurminen method|||||17.4|-13.0|= 0.9873
91536116|NCT03568318|182951347|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.4|43.8|<0.001
91536117|NCT03568318|182951347|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|30.8|45.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.4|30.8|<0.001
91536118|NCT03568318|182951348|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.6|||<|0.001|TWO_SIDED|95.0|41.1|54.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||54.0|41.1|<0.001
91536119|NCT03568318|182951348|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|28.5|||<|0.001|TWO_SIDED|95.0|22.1|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||34.9|22.1|<0.001
91536120|NCT03568318|182951349|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.8|||<|0.001|TWO_SIDED|95.0|41.9|55.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.7|41.9|<0.001
91536121|NCT03568318|182951349|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|29.7|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|29.7|<0.001
91536122|NCT03568318|182951350|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.9|||<|0.001|TWO_SIDED|95.0|43.3|56.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.4|43.3|<0.001
91536123|NCT03568318|182951350|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.5|||<|0.001|TWO_SIDED|95.0|22.8|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||36.3|22.8|<0.001
91536124|NCT03568318|182951351|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|43.8|<0.001
91536125|NCT03568318|182951351|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.4|||<|0.001|TWO_SIDED|95.0|30.4|44.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.3|30.4|<0.001
91762277|NCT02058563|183415805|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.91|
91517830|NCT04953390|182910142|OTHER|||||||0.14|||||||t-test, 2 sided|T-test done on DIR2 and DIR3 results only, as the conditions were equal for these two settings. DIR1 was tested in a different condition.||All three DIR settings were tested, but only the DIR2 and DIR3 were compared in t-test. This is because DIR1 mic setting was tested in a different condition (i.e. softer noise).||||.14
91762278|NCT02058563|183415806|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.||1.16|0.96|
91762279|NCT02058563|183415807|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.93|
91762280|NCT00483938|183415827|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||SVR: Group A versus Group B||||0.510
91762281|NCT00483938|183415828|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group C versus Group D||||1.000
91762282|NCT00483938|183415828|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group E versus Group F||||1.000
91762283|NCT00483938|183415829|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||ETR: Group A versus Group B||||0.792
91762284|NCT00483938|183415829|SUPERIORITY_OR_OTHER|||||||0.612|||||||Fisher Exact|||ETR: Group C versus Group D||||0.612
91762285|NCT00483938|183415829|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||ETR: Group E versus Group F||||0.490
91762286|NCT00483938|183415829|SUPERIORITY_OR_OTHER|||||||0.363|||||||Fisher Exact|||Complete EVR: Group C versus Group D||||0.363
91762287|NCT00483938|183415829|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Complete EVR: Group E versus Group F||||1.000
91517831|NCT04953390|182910145|OTHER|||||||0.0003|||||||ANOVA|||||||.0003
91762288|NCT00042991|183415851|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91762289|NCT00042991|183415852|SUPERIORITY_OR_OTHER|||||||0.0546||95.0|||||Wilcoxon (Mann-Whitney)|||19 patients had Enhancing tumor at both Baseline and Post-RT time points. Thus, the following test was based on these 19 patients.||||0.0546
91762290|NCT00042991|183415853|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91762291|NCT00042991|183415854|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
91762292|NCT03334812|183415887|SUPERIORITY||Mean Difference (Net)|0.18||||0.1219|TWO_SIDED|95.0|-0.15|0.51|||Mixed Effect Model Repeat Measurement|||SCD/HNWB||0.51|-0.15|0.1219
91762293|NCT03334812|183415887|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5438|TWO_SIDED|95.0|-0.28|0.25|||Mixed Effect Model Repeat Measurement|||DTBT/HWB||0.25|-0.28|0.5438
91762294|NCT03334812|183415888|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.3067|TWO_SIDED|95.0|-0.19|0.31|||Mixed Effect Model Repeat Measurement|||||0.31|-0.19|0.3067
91762295|NCT03334812|183415890|SUPERIORITY||Mean Difference (Net)|26.23||||0.0404|TWO_SIDED|95.0|-3.86|56.32|||Mixed Effect Model Repeat Measurement|||Week 4||56.32|-3.86|0.0404
91762296|NCT03334812|183415890|SUPERIORITY||Mean Difference (Net)|27.82||||0.1381|TWO_SIDED|95.0|-26.5|82.1|||Mixed Effect Model Repeat Measurement|||Week 12||82.10|-26.5|0.1381
91762297|NCT03334812|183415890|SUPERIORITY||Mean Difference (Net)|23.8||||0.1168|TWO_SIDED|96.0|-19.3|66.89|||Mixed Models Analysis|||Week 28 (EOS)||66.89|-19.3|0.1168
91762298|NCT03334812|183415891|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5175|TWO_SIDED|95.0|-0.26|0.25|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 12||0.25|-0.26|0.5175
91762299|NCT03334812|183415891|SUPERIORITY||Mean Difference (Net)|0.19||||0.1476|TWO_SIDED|95.0|-0.22|0.6|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 28||0.60|-0.22|0.1476
91762300|NCT02508428|183415896|EQUIVALENCE|Differences in survivorship among the Marathon and Enduron liners were evaluated with a Log Rank test.|||||<|0.001||||||A p-value of 0.05 was used as the threshold for statistical significance.|Log Rank|||Survivorship was evaluated using liner revision for wear/osteolysis as an endpoint using a Kaplan-Meier analysis.||||<0.001
91762301|NCT02508428|183415897|EQUIVALENCE|"Since the null hypothesis assumed that the wear rates were not different, Equivalence has been specified for the Type of Statistical Test"|Mean Difference (Net)|0.22|||<|0.001|TWO_SIDED|95.0|0.17|0.27||A p-value of 0.05 was used as the threshold for statistical significance.|t-test, 2 sided|||||0.27|0.17|<0.001
91517832|NCT03035292|182910149|SUPERIORITY||||||<|0.05||||||This value of \<0.05 is the calculated p value where the a priori threshold for statistical significance is considered to be p=0.05.|McNemar|||Sample size was based on a cataract prevalence of 20% in the enriched population and a predicted difference of 15% sensitivity and specificity between tests.||||<0.05
91536126|NCT03568318|182951352|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.6|||<|0.001|TWO_SIDED|95.0|51.2|63.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.9|51.2|<0.001
91536127|NCT03568318|182951352|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|37.0|50.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.5|37.0|<0.001
91536128|NCT03568318|182951353|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.2|||<|0.001|TWO_SIDED|95.0|31.0|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|31.0|<0.001
91517833|NCT03035292|182910151|SUPERIORITY||||||<|0.05||||||The calculated p value was \<0.05. A priori threshold for statistical significance is p=0.05|Fisher Exact|||Evidence of superiority of intervention 2 over intervention 1 requires a significant difference in specificity of the intervention 1 and 2 between ethnicity groups.||||<0.05
91517834|NCT00677833|182910152|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-9.1|||||TWO_SIDED|95.0|-16.02|-2.18|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-2.18|-16.02|
91517835|NCT00677833|182910153|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-6.08|||||TWO_SIDED|95.0|-12.1|-0.05|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-0.05|-12.10|
91517836|NCT00677833|182910154|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
91517837|NCT00677833|182910154|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.74|||||TWO_SIDED|95.0|-12.15|-1.32|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-1.32|-12.15|
91517838|NCT00677833|182910154|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.78|||||TWO_SIDED|95.0|-12.82|-0.75|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-0.75|-12.82|
91517839|NCT00677833|182910154|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.92|||||TWO_SIDED|95.0|-14.59|0.76|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||0.76|-14.59|
91517840|NCT00677833|182910154|SUPERIORITY_OR_OTHER||ACPR percent difference|-8.63|||||TWO_SIDED|95.0|-17.08|-0.18|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-0.18|-17.08|
91517841|NCT00677833|182910155|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.63|||||TWO_SIDED|95.0|-8.4|1.14|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||1.14|-8.40|
91517842|NCT00677833|182910155|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.87|||||TWO_SIDED|95.0|-10.79|3.04|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||3.04|-10.79|
91517843|NCT00677833|182910155|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.66|||||TWO_SIDED|95.0|-13.55|2.22|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||2.22|-13.55|
91517844|NCT00677833|182910156|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
91517845|NCT00677833|182910156|SUPERIORITY_OR_OTHER||ACPR percent difference|-7.71|||||TWO_SIDED|95.0|-14.54|-0.88|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-0.88|-14.54|
91517846|NCT00677833|182910156|SUPERIORITY_OR_OTHER||ACPR percent difference|-15.09|||||TWO_SIDED|95.0|-26.24|-3.94|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-3.94|-26.24|
91762302|NCT02508428|183415898|EQUIVALENCE|"Since the null hypothesis assumed that the incidences of clinically important osteolysis were not different, Equivalence has been specified for the Type of Statistical Test"|Risk Ratio (RR)|0.04|||<|0.001|TWO_SIDED|95.0|0.006|0.3||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||||0.30|0.006|<0.001
91762303|NCT02508428|183415899|EQUIVALENCE|"Since the null hypothesis assumed that the rate of satisfaction among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.48||||||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||Since there were no patients with Marathon liners who were unsatisfied with the outcome of their hip replacement, a relative risk and the associated confidence interval could not be calculated.||||0.48
91762304|NCT02508428|183415900|EQUIVALENCE|"Since the null hypothesis assumed that the Harris Hip Scores among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.4||||||A p-value of 0.05 was used as the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||.40
91762305|NCT00108862|183415917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.45|TWO_SIDED|95.08|-2.0|8.0||The analysis was stratified by screening CD4 (\<50 cells/mm3 vs =\>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided|A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.|The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.||8|-2|0.45
91762306|NCT00108862|183415918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.0||0.02|TWO_SIDED|95.08|2.0|21.0||Interim reviews employed group sequential monitoring using an\> O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||21|2|0.02
91762307|NCT00108862|183415919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.0||0.67|TWO_SIDED|95.08|-7.0|4.0||Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||4|-7|0.67
91762308|NCT00900666|183415929|NON_INFERIORITY_OR_EQUIVALENCE|a priori power calculation suggested N=26 for each group.||||||0.761|TWO_SIDED|95.0||||p\<0.05 threshold|ANOVA|Correlations with walking speed and time since injury were initially performed to determine whether ANCOVA would be be more appropriate.||ANOVA||||0.761
91762309|NCT00900666|183415930|SUPERIORITY_OR_OTHER|||||||0.896||95.0|||||ANOVA|||||||.896
91762310|NCT00684775|183415957|SUPERIORITY||Odds Ratio (OR)|6.0|||=|0.002|TWO_SIDED|95.0|1.44|25.0|||General Estimating Equation (GEE)|||||25.0|1.44|=0.002
91762311|NCT00684775|183415958|SUPERIORITY|||||||0.0081|||||||t-test, 2 sided|||||||0.0081
91762312|NCT00684775|183415959|SUPERIORITY||Odds Ratio (OR)|1.34||||0.56|TWO_SIDED|95.0|0.5|3.6|||General Estimating Equation (GEE)|||||3.6|.5|0.56
91762313|NCT00684775|183415960|SUPERIORITY||Odds Ratio (OR)|1.45|||=|0.41|TWO_SIDED|95.0|0.6|3.53|||General Estimating Equation (GEE)|||||3.53|.6|=0.41
91762314|NCT00684775|183415961|SUPERIORITY||Odds Ratio (OR)|1.19||||0.75|TWO_SIDED|95.0|0.42|3.36|||General Estimating Equation (GEE)|||||3.36|.42|0.75
91762315|NCT00684775|183415962|SUPERIORITY|||||||0.1543|||||||t-test, 2 sided|||||||0.1543
91762316|NCT00684775|183415963|SUPERIORITY||Odds Ratio (OR)|1.82||||0.15|TWO_SIDED|95.0|0.81|4.1|||General Estimating Equation (GEE)|||||4.1|.81|0.15
91762317|NCT00555672|183415972|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.3|||||TWO_SIDED|95.0|13.3|45.5|||Fisher Exact|Exact Method based on the F Distribution.||||45.5|13.3|
91762318|NCT02324816|183415988|OTHER||success proportion|73.7|||||TWO_SIDED|95.0|48.8|90.9||||||||90.9|48.8|
91762319|NCT03401671|183415989|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.0229|||||TWO_SIDED|90.0|0.8473|1.2349||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.2349|0.8473|
91762320|NCT03401671|183415991|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9324|||||TWO_SIDED|90.0|0.8016|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8016|
91762321|NCT03401671|183415992|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9318|||||TWO_SIDED|90.0|0.8005|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8005|
91762322|NCT02305238|183416007|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) mean difference|-0.4|||||TWO_SIDED|95.0|-3.8|3.0||||||||3.0|-3.8|
91762323|NCT02305238|183416008|SUPERIORITY_OR_OTHER_LEGACY||Mantel-Haenszel (MH) adjusted difference|-0.9|||||TWO_SIDED|95.0|-5.7|4.0||||||||4.0|-5.7|
91762324|NCT02305238|183416009|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|-1.4|||||TWO_SIDED|95.0|-12.7|9.8||||||||9.8|-12.7|
91762325|NCT02305238|183416010|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.8|||||TWO_SIDED|95.0|-24.3|12.7||||||||12.7|-24.3|
91762326|NCT02305238|183416011|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|1.0|||||TWO_SIDED|95.0|-10.6|12.7||||||||12.7|-10.6|
91762327|NCT02815644|183416014|SUPERIORITY_OR_OTHER||T/R ratio|55.69|STANDARD_ERROR_OF_MEAN|1.087|||TWO_SIDED|90.0|48.22|64.33|||||Standard Error of the mean is actually geometric Standard Error of the mean.|"Relative bioavailability of linagliptin after food intake compared to while in the fasting state was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||64.33|48.22|
91762328|NCT02815644|183416015|SUPERIORITY_OR_OTHER||T/R ratio|74.89|STANDARD_ERROR_OF_MEAN|1.073|||TWO_SIDED|90.0|66.27|84.64|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||84.64|66.27|
91762329|NCT02815644|183416016|SUPERIORITY_OR_OTHER||T/R ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
91762330|NCT02815644|183416017|SUPERIORITY_OR_OTHER||T/R ratio|85.99|STANDARD_ERROR_OF_MEAN|1.018|||TWO_SIDED|90.0|83.38|88.68|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||88.68|83.38|
91762331|NCT02815644|183416018|SUPERIORITY_OR_OTHER||T/R ratio|88.13|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|90.0|80.89|96.03|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||96.03|80.89|
91762332|NCT02815644|183416019|SUPERIORITY_OR_OTHER||T/R ratio|86.33|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|83.61|89.13|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||89.13|83.61|
91762333|NCT02815644|183416020|SUPERIORITY_OR_OTHER||T/R Ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
91762334|NCT02218008|183416021|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.018|TWO_SIDED|95.0|-2.7|-0.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.3|-2.7|0.018
91762335|NCT02218008|183416022|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Least Squares Mean Difference|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2||ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Mixed Models Analysis||Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.2|-3.6|0.026
91536129|NCT03568318|182951353|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.1|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.1|<0.001
91762336|NCT02218008|183416023|SUPERIORITY|The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.|Least Squares Mean Difference|-1.7||||0.076|TWO_SIDED|95.0|-3.6|0.2||ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.|Mixed Models Analysis|||ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.||0.2|-3.6|0.076
91762337|NCT01278797|183416076|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.51||||0.005||90.0|91.6|97.51|||ANOVA|ANOVA was applied to log-transformed AUC72 and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.51|91.60|0.005
91762338|NCT01278797|183416077|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.1||||0.0093||90.0|90.7|97.63|||ANOVA|ANOVA was applied to log-transformed CMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.63|90.70|0.0093
91517847|NCT00677833|182910156|SUPERIORITY_OR_OTHER||ACPR percent difference|-21.76|||||TWO_SIDED|95.0|-34.14|-9.39|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-9.39|-34.14|
91517848|NCT00677833|182910156|SUPERIORITY_OR_OTHER||ACPR percent difference|-18.24|||||TWO_SIDED|95.0|-31.05|-5.43|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-5.43|-31.05|
91536130|NCT03568318|182951354|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|32.8|44.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.8|32.8|<0.001
91536131|NCT03568318|182951354|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|23.3|||<|0.001|TWO_SIDED|95.0|17.7|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||28.9|17.7|<0.001
91536132|NCT03568318|182951355|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|16.3|26.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||26.1|16.3|<0.001
91536133|NCT03568318|182951356|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.3|<0.001
91536134|NCT03568318|182951356|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|9.2|||<|0.001|TWO_SIDED|95.0|4.9|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||13.4|4.9|<0.001
91536135|NCT03568318|182951357|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|4.417|<|0.001|TWO_SIDED|95.0|-50.46|-33.11|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.11|-50.46|<0.001
91536136|NCT03568318|182951357|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|LS Mean Difference|-33.08|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-41.72|-24.44|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-24.44|-41.72|<0.001
91536137|NCT03568318|182951358|SUPERIORITY||LS Mean Difference|-41.45|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-46.68|-36.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||-36.22|-46.68|<0.001
91762339|NCT01278797|183416078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.153|||||||ANOVA|ANOVA was applied to TMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg||||0.153
91762340|NCT00588354|183416079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.05||0.159|TWO_SIDED|95.0|-0.52|3.6|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||3.60|-0.52|0.159
91762341|NCT00588354|183416080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.97||0.91|TWO_SIDED|95.0|-1.79|2.01|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.01|-1.79|0.910
91762342|NCT00588354|183416081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96|STANDARD_ERROR_OF_MEAN|2.04||0.162|TWO_SIDED|95.0|-1.04|6.96|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.96|-1.04|0.162
91762343|NCT00588354|183416082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.67|STANDARD_ERROR_OF_MEAN|2.27||0.022|TWO_SIDED|95.0|1.22|10.12|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||10.12|1.22|0.022
91762344|NCT00588354|183416083|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.86|STANDARD_ERROR_OF_MEAN|3.28||0.089|TWO_SIDED|95.0|-0.57|12.29|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||12.29|-0.57|0.089
91513613|NCT03893448|182899002|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.24|||<|0.001|TWO_SIDED|95.0|1.1|1.39|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.10|< 0.001
91513614|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.66|||<|0.001|TWO_SIDED|95.0|0.62|0.72|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.72|0.62|< 0.001
91513615|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
91513616|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.84|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.84|0.71|< 0.001
91513617|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.63|||<|0.001|TWO_SIDED|95.0|0.58|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.58|< 0.001
91513618|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.65|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.65|0.54|< 0.001
91513619|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.81|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.81|0.67|< 0.001
91513620|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
91513621|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.67|< 0.001
91513622|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.89|0.73|< 0.001
91513623|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.85|||<|0.001|TWO_SIDED|95.0|0.78|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.78|< 0.001
91762345|NCT00588354|183416084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.04|STANDARD_ERROR_OF_MEAN|3.17||0.038|TWO_SIDED|95.0|0.83|13.25|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||13.25|0.83|0.038
91762346|NCT00588354|183416085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.83|STANDARD_ERROR_OF_MEAN|3.53||0.186|TWO_SIDED|95.0|-11.75|2.09|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.09|-11.75|0.186
91762347|NCT00588354|183416086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|3.37||0.918|TWO_SIDED|95.0|-6.96|6.26|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.26|-6.96|0.918
91762348|NCT03364309|183416087|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.0001|TWO_SIDED|95.0|33.57|99.99|||Regression, Logistic|||||99.99|33.57|<0.0001
91762349|NCT03364309|183416087|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|52.49|99.99|||Regression, Logistic|||||99.99|52.49|<0.001
91762350|NCT03364309|183416088|SUPERIORITY||Odds Ratio (OR)|79.95|||<|0.001|TWO_SIDED|95.0|32.76|99.99|||Regression, Logistic|||||99.99|32.76|<0.001
91762351|NCT03364309|183416088|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|64.87|99.99|||Regression, Logistic|||||99.99|64.87|<0.001
91762352|NCT03364309|183416090|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|31.88|99.99|||Regression, Logistic|||||99.99|31.88|<0.001
91762353|NCT03364309|183416090|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|46.96|99.99|||Regression, Logistic|||||99.99|46.96|<0.001
91762354|NCT03364309|183416092|SUPERIORITY||Odds Ratio (OR)|37.24|||<|0.001|TWO_SIDED|95.0|13.68|99.99|||Regression, Logistic|||||99.99|13.68|<0.001
91762355|NCT03364309|183416092|SUPERIORITY||Odds Ratio (OR)|41.38|||<|0.001|TWO_SIDED|95.0|15.09|99.99|||Regression, Logistic|||||99.99|15.09|<0.001
91762356|NCT03364309|183416093|SUPERIORITY||LSMean Difference|-9.52|STANDARD_ERROR_OF_MEAN|0.604|<|0.001|TWO_SIDED|95.0|-10.71|-8.33|||Mixed Models Analysis|||||-8.33|-10.71|<0.001
91762357|NCT03364309|183416093|SUPERIORITY||LSMean Difference|-9.78|STANDARD_ERROR_OF_MEAN|0.603|<|0.001|TWO_SIDED|95.0|-10.96|-8.59|||Mixed Models Analysis|||||-8.59|-10.96|<0.001
91762358|NCT03364309|183416094|SUPERIORITY||LSMean Difference|-10.09|STANDARD_ERROR_OF_MEAN|1.673|<|0.001|TWO_SIDED|95.0|-13.38|-6.79|||Mixed Models Analysis|||||-6.79|-13.38|<0.001
91762359|NCT03364309|183416094|SUPERIORITY||LSMean Difference|-8.81|STANDARD_ERROR_OF_MEAN|1.677|<|0.001|TWO_SIDED|95.0|-12.11|-5.51|||Mixed Models Analysis|||||-5.51|-12.11|<0.001
91762360|NCT03364309|183416095|SUPERIORITY||LSMean Difference|-34.96|STANDARD_ERROR_OF_MEAN|2.023|<|0.001|TWO_SIDED|95.0|-38.94|-30.98|||Mixed Models Analysis|||||-30.98|-38.94|<0.001
91762361|NCT03364309|183416095|SUPERIORITY||LSMean Difference|-36.34|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-40.3|-32.37|||Mixed Models Analysis|||||-32.37|-40.30|<0.001
91762362|NCT03364309|183416096|SUPERIORITY||LSMean Difference|-16.74|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-18.62|-14.86|||Mixed Models Analysis|||||-14.86|-18.62|<0.001
91762363|NCT03364309|183416096|SUPERIORITY||LSMean Difference|-17.93|STANDARD_ERROR_OF_MEAN|0.954|<|0.001|TWO_SIDED|95.0|-19.8|-16.05|||Mixed Models Analysis|||||-16.05|-19.80|<0.001
91762364|NCT03364309|183416097|SUPERIORITY||LSMean Difference|6.228|STANDARD_ERROR_OF_MEAN|0.6681|<|0.001|TWO_SIDED|95.0|4.915|7.541|||Mixed Models Analysis|||||7.541|4.915|<0.001
91762365|NCT03364309|183416097|SUPERIORITY||LSMean Difference|6.536|STANDARD_ERROR_OF_MEAN|0.6668|<|0.001|TWO_SIDED|95.0|5.225|7.847|||Mixed Models Analysis|||||7.847|5.225|<0.001
91762366|NCT03364309|183416098|SUPERIORITY||LSMean Difference|5.193|STANDARD_ERROR_OF_MEAN|0.9489|<|0.001|TWO_SIDED|95.0|3.328|7.058|||Mixed Models Analysis|||||7.058|3.328|<0.001
91762367|NCT03364309|183416098|SUPERIORITY||LSMean Difference|5.362|STANDARD_ERROR_OF_MEAN|0.946|<|0.001|TWO_SIDED|95.0|3.503|7.222|||Mixed Models Analysis|||||7.222|3.503|<0.001
91762368|NCT03364309|183416099|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.4|||Mixed Models Analysis|||||-2.4|-2.9|<0.001
91762369|NCT03364309|183416099|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.3|||Mixed Models Analysis|||||-2.3|-2.9|<0.001
91762370|NCT03364309|183416100|SUPERIORITY||LSMean Difference|-3.35|STANDARD_ERROR_OF_MEAN|1.11||0.003|TWO_SIDED|95.0|-5.56|-1.15|||Mixed Models Analysis|||||-1.15|-5.56|0.003
91762371|NCT03364309|183416100|SUPERIORITY||LSMean Difference|-4.79|STANDARD_ERROR_OF_MEAN|1.064|<|0.001|TWO_SIDED|95.0|-6.9|-2.67|||Mixed Models Analysis|||||-2.67|-6.90|<0.001
91762372|NCT03364309|183416101|SUPERIORITY||LSMean Difference|-27.4|STANDARD_ERROR_OF_MEAN|11.07||0.022|TWO_SIDED|95.0|-50.5|-4.3|||Mixed Models Analysis|||||-4.3|-50.5|0.022
91762373|NCT03364309|183416101|SUPERIORITY||LSMean Difference|-25.2|STANDARD_ERROR_OF_MEAN|10.87||0.031|TWO_SIDED|95.0|-47.8|-2.5|||Mixed Models Analysis|||||-2.5|-47.8|0.031
91762374|NCT04522141|183416121|OTHER|||||||0.038||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.038
91762375|NCT04522141|183416121|SUPERIORITY|||||||0.941||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.941
91762376|NCT04522141|183416122|OTHER|||||||0.003||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.003
91762377|NCT04522141|183416122|SUPERIORITY|||||||0.027||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.027
91762378|NCT04522141|183416123|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||< .001
91762379|NCT04522141|183416123|SUPERIORITY|||||||0.411||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.411
91762380|NCT04522141|183416124|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Main effect weekly self-control||||< .001
91762381|NCT04522141|183416124|SUPERIORITY|||||||0.176||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Time by condition interaction weekly self-control||||0.176
91762382|NCT04522141|183416125|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
91762383|NCT04522141|183416125|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
91762384|NCT04522141|183416126|OTHER|||||||0.031||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.031
91762385|NCT04522141|183416126|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.||Time by condition interaction||||0.260
91762386|NCT04522141|183416127|OTHER|||||||0.016||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.016
91762387|NCT04522141|183416127|SUPERIORITY|||||||0.363||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.363
91762388|NCT04522141|183416128|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
91762389|NCT04522141|183416128|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
91762390|NCT04522141|183416129|OTHER|||||||0.389||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.389
91762391|NCT04522141|183416129|SUPERIORITY|||||||0.516||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.516
91762392|NCT04522141|183416130|OTHER|||||||0.005||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.005
91762393|NCT04522141|183416130|SUPERIORITY|||||||0.555||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.555
91762394|NCT04522141|183416131|OTHER|||||||0.206||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.206
91762395|NCT04522141|183416131|SUPERIORITY|||||||0.026||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.026
91762396|NCT03052049|183416132|OTHER|t-test|p value|0.05||||0.05|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.05
91762397|NCT03052049|183416133|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
91762398|NCT03052049|183416134|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
91762399|NCT03052049|183416135|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
91762400|NCT03052049|183416136|SUPERIORITY|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
91762401|NCT03304873|183416154|SUPERIORITY|||||||0.0004|||||||t-test, 1 sided|||||||0.0004
91762402|NCT03304873|183416155|SUPERIORITY|||||||0.99|||||||t-test, 1 sided|||||||0.99
91762403|NCT01868477|183416174|OTHER|difference|Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-24.0|48.16||||||||48.16|-24.0|
91762404|NCT00620113|183416195|SUPERIORITY_OR_OTHER||Difference in LS Means|5.4|||<|0.001|TWO_SIDED|95.0|4.16|6.64||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an analysis of covariance (ANCOVA) model with terms for treatment and study center. Treatment effect was assessed by Least-Squares means (LS mean) and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.64|4.16|<0.001
91762405|NCT00620113|183416195|SUPERIORITY_OR_OTHER||Difference in LS Means|5.12|||<|0.001|TWO_SIDED|95.0|3.9|6.35||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.35|3.90|<0.001
91762406|NCT00620113|183416195|SUPERIORITY_OR_OTHER||Difference in LS Means|3.54|||<|0.001|TWO_SIDED|95.0|2.33|4.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.75|2.33|<0.001
91536138|NCT03568318|182951358|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-32.13|STANDARD_ERROR_OF_MEAN|2.659|<|0.001|TWO_SIDED|95.0|-37.35|-26.91|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-26.91|-37.35|<0.001
91536139|NCT03568318|182951359|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|38.8|67.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.4|38.8|<0.001
91536140|NCT03568318|182951359|SUPERIORITY||Adjusted Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|16.3|49.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.0|16.3|<0.001
91536141|NCT03568318|182951360|SUPERIORITY||Adjusted Response Rate Difference|55.4|||<|0.001|TWO_SIDED|95.0|41.4|69.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.5|41.4|<0.001
91536142|NCT03568318|182951360|SUPERIORITY||Adjusted Response Rate Difference|26.3|||<|0.001|TWO_SIDED|95.0|12.1|40.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.4|12.1|<0.001
91536143|NCT03568318|182951361|SUPERIORITY||Adjusted Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|14.1|46.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.8|14.1|<0.001
91536144|NCT03568318|182951361|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.003|TWO_SIDED|95.0|8.2|40.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.8|8.2|0.003
91536145|NCT03568318|182951362|SUPERIORITY||Adjusted Response Rate Difference|52.0|||<|0.001|TWO_SIDED|95.0|37.3|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|37.3|<0.001
91536146|NCT03568318|182951362|SUPERIORITY||Adjusted Response Rate Difference|27.1||||0.001|TWO_SIDED|95.0|11.1|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|11.1|0.001
91536147|NCT03568318|182951363|SUPERIORITY||Adjusted Response Rate Difference|23.5||||0.006|TWO_SIDED|95.0|6.9|40.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.1|6.9|0.006
91536148|NCT03568318|182951363|SUPERIORITY||Adjusted Response Rate Difference|22.7||||0.007|TWO_SIDED|95.0|6.2|39.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||39.2|6.2|0.007
91536149|NCT03568318|182951364|SUPERIORITY||Adjusted Response Rate Difference|49.3|||<|0.001|TWO_SIDED|95.0|34.1|64.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.6|34.1|<0.001
91536150|NCT03568318|182951364|SUPERIORITY||Adjusted Response Rate Difference|26.2||||0.002|TWO_SIDED|95.0|9.4|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|9.4|0.002
91536151|NCT03568318|182951365|SUPERIORITY||Adjusted Response Rate Difference|41.5|||<|0.001|TWO_SIDED|95.0|27.8|55.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||55.1|27.8|<0.001
91536152|NCT03568318|182951365|SUPERIORITY||Adjusted Response Rate Difference|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.4|10.3|0.001
91536153|NCT03568318|182951366|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|20.6|49.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.3|20.6|<0.001
91536154|NCT03568318|182951366|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.001|TWO_SIDED|95.0|10.4|38.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.7|10.4|0.001
91536155|NCT03568318|182951367|SUPERIORITY||Adjusted Response Rate Difference|19.8||||0.001|TWO_SIDED|95.0|7.8|31.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.8|7.8|0.001
91536156|NCT03568318|182951368|SUPERIORITY||Adjusted Response Rate Difference|6.2||||0.306|TWO_SIDED|95.0|-5.7|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||18.2|-5.7|0.306
91536157|NCT03568318|182951368|SUPERIORITY||Adjusted Response Rate Difference|-1.0||||0.855|TWO_SIDED|95.0|-11.2|9.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||9.3|-11.2|0.855
91536158|NCT03568318|182951369|SUPERIORITY||LS Mean Difference|-16.05|STANDARD_ERROR_OF_MEAN|11.956||0.18|TWO_SIDED|95.0|-39.59|7.48|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||7.48|-39.59|0.180
91536159|NCT03568318|182951369|SUPERIORITY||LS Mean Difference|-26.38|STANDARD_ERROR_OF_MEAN|11.986||0.029|TWO_SIDED|95.0|-49.97|-2.79|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-2.79|-49.97|0.029
91536160|NCT03568318|182951370|SUPERIORITY||LS Mean Difference|-35.69|STANDARD_ERROR_OF_MEAN|5.354|<|0.001|TWO_SIDED|95.0|-46.28|-25.11|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-25.11|-46.28|<0.001
91536161|NCT03568318|182951370|SUPERIORITY||LS Mean Difference|-24.37|STANDARD_ERROR_OF_MEAN|5.423|<|0.001|TWO_SIDED|95.0|-35.1|-13.65|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-13.65|-35.10|<0.001
91536162|NCT03720990|182951371|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
91536163|NCT01249092|182951372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-57.3|STANDARD_DEVIATION|62.1||0.001|TWO_SIDED|95.0|-88.2|-26.4||This study tested the hypothesis that treatment with pentoxifylline would result in a statistically significant change from baseline in the level of alkaline phosphatase.|Paired t-test|||A p-value \< 0.05 was considered statistically significant and all analyses were carried out using SAS version 9.2 (The SAS Institute, Cary, NC). Matched pairs t-test was used to compare the change in alkaline phosphatase from baseline. The efficacy of therapy was measured based on improvement in AP levels after therapy with PTX. AP levels at end of the study were compared with values at baseline by matched pairs t-test.||-26.4|-88.2|0.001
91536164|NCT01249092|182951373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.69|STANDARD_ERROR_OF_MEAN|8.66||0.5|TWO_SIDED|95.0|-24.14|8.68||Hypothesis tested if TIMP-1 levels after therapy with pentoxifylline changed significantly from baseline from baseline.|Paired t-test.|||Change from baseline in TIMP-1 levels was assessed by paired-t test. Distribution the variable values was assessed using normal probability plots. Matched pairs t-test was used to compare the change from baseline.||8.68|-24.14|0.5
91536165|NCT00286741|182951390|SUPERIORITY_OR_OTHER|||||||0.15|||||||Mixed Models Analysis|||||||0.15
91536166|NCT00286741|182951391|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91536167|NCT05197049|182951393|SUPERIORITY||Adjusted treatment difference:percentage|34.9|||<|0.001|TWO_SIDED|95.0|25.1|44.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||44.6|25.1|< 0.001
91536168|NCT05197049|182951394|SUPERIORITY||Adjusted treatment difference:percentage|19.9|||<|0.001|TWO_SIDED|95.0|10.2|29.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||29.6|10.2|< 0.001
91536169|NCT05197049|182951395|SUPERIORITY||Adjusted treatment difference:percentage|37.0|||<|0.001|TWO_SIDED|95.0|25.6|48.4|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||48.4|25.6|< 0.001
91536170|NCT05197049|182951395|SUPERIORITY||Adjusted treatment difference:percentage|39.3|||<|0.001|TWO_SIDED|95.0|28.0|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|28.0|< 0.001
91536171|NCT05197049|182951396|SUPERIORITY||Adjusted treatment difference:percentage|32.1|||<|0.001|TWO_SIDED|95.0|22.9|41.2|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||41.2|22.9|< 0.001
91536172|NCT05197049|182951397|SUPERIORITY||Adjusted treatment difference:percentage|40.3|||<|0.001|TWO_SIDED|95.0|29.9|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|29.9|< 0.001
91536173|NCT01460342|182951420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.4|-0.6|||Mixed Models Analysis|||||-0.6|-2.4|<0.001
91536174|NCT01460342|182951421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-0.5||The p-value is for the change from baseline in the IPSS Total Score at Week 4.|Mixed Models Analysis|||||-0.5|-2.0|<0.001
91536175|NCT01460342|182951421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-2.0|-0.4||The p-value is for the change from baseline in the IPSS Total Score at Week 8.|Mixed Models Analysis|||||-0.4|-2.0|0.003
91536176|NCT01460342|182951422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED|95.0|-0.6|0.0||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 4.|Mixed Models Analysis|||||0.0|-0.6|0.090
91536177|NCT01460342|182951422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.8|-0.1||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 8.|Mixed Models Analysis|||||-0.1|-0.8|0.011
91536178|NCT01460342|182951422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-0.9|-0.2||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 12.|Mixed Models Analysis|||||-0.2|-0.9|0.002
91536179|NCT01460342|182951423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.5|-0.4||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 4.|Mixed Models Analysis|||||-0.4|-1.5|<0.001
91536180|NCT01460342|182951423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.3|-0.2||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 8.|Mixed Models Analysis|||||-0.2|-1.3|0.007
91536181|NCT01460342|182951423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002|TWO_SIDED|95.0|-1.5|-0.3||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 12.|Mixed Models Analysis|||||-0.3|-1.5|0.002
91536182|NCT01460342|182951424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.277|TWO_SIDED|95.0|-0.2|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 4.|Mixed Models Analysis|||||0.1|-0.2|0.277
91536183|NCT01460342|182951424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.17|TWO_SIDED|95.0|-0.3|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 8.|Mixed Models Analysis|||||0.1|-0.3|0.170
91536184|NCT01460342|182951424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.038|TWO_SIDED|95.0|-0.4|0.0||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 12.|Mixed Models Analysis|||||-0.0|-0.4|0.038
91513624|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.68|< 0.001
91513625|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.79|||<|0.001|TWO_SIDED|95.0|0.74|0.86|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.74|< 0.001
91513626|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.61|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.56|< 0.001
91513627|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|4.69|||<|0.001|TWO_SIDED|95.0|4.3|5.11|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||5.11|4.30|< 0.001
91513628|NCT03893448|182899003|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|2.59|||<|0.001|TWO_SIDED|95.0|2.36|2.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.83|2.36|< 0.001
91513629|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-2.6|1.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.1|-2.6|< 0.001
91513630|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.4|< 0.001
91513631|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.7|1.9||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.9|-0.7|< 0.001
91513632|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-1.3|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-1.3|< 0.001
91513633|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|2.0|||<|0.001|TWO_SIDED|95.0|-3.1|7.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||7.1|-3.1|< 0.001
91513634|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|1.8|||<|0.001|TWO_SIDED|95.0|-3.2|6.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||6.8|-3.2|< 0.001
91513635|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.7|< 0.001
91536185|NCT01460342|182951425|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
91513636|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
91513637|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
91517849|NCT00677833|182910156|SUPERIORITY_OR_OTHER||ACPR Percent difference|-18.49|||||TWO_SIDED|95.0|-31.33|-5.65|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-5.65|-31.33|
91517850|NCT00677833|182910157|SUPERIORITY_OR_OTHER||ACPR percent difference|-4.67|||||TWO_SIDED|95.0|-10.6|1.25|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||1.25|-10.60|
91762407|NCT00620113|183416196|SUPERIORITY_OR_OTHER||Difference in LS Means|3.06|||<|0.001|TWO_SIDED|95.0|2.14|3.98||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.98|2.14|<0.001
91762408|NCT00620113|183416196|SUPERIORITY_OR_OTHER||Difference in LS Means|2.2|||<|0.001|TWO_SIDED|95.0|1.29|3.12||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.12|1.29|<0.001
91762409|NCT00620113|183416196|SUPERIORITY_OR_OTHER||Difference in LS Means|1.67|||<|0.001|TWO_SIDED|95.0|0.77|2.57||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||2.57|0.77|<0.001
91762410|NCT00620113|183416199|SUPERIORITY_OR_OTHER||Difference in LS Means|3.08|||<|0.001|TWO_SIDED|95.0|1.85|4.31||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.31|1.85|<0.001
91762411|NCT00620113|183416199|SUPERIORITY_OR_OTHER||Difference in LS Means|1.86||||0.003|TWO_SIDED|95.0|0.64|3.08||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.08|0.64|0.003
91536186|NCT01460342|182951426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
91536187|NCT01460342|182951427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.2|0.0|||ANCOVA|||||0.0|-1.2|0.060
91536188|NCT01549652|182951439|SUPERIORITY_OR_OTHER|||||||0.87||||||Students' t-tests for paired samples with Bonferroni correction for multiple comparisons were used to compare differences between the outcome measures for crossover treatment arms (placebo vs. ondansetron).|t-test, 2 sided|||For the purposes of our post-hoc power calculation we considered a 30% treatment effect clinically significant. Based on the mean observed OOWS score during withdrawal during the placebo session and the variance of that mean score and assuming a paired data analysis and an alpha of 0.05, we found that we had 80% power to detect a treatment effect as low as 25% reduction in OOWS.||||0.87
91536189|NCT01549652|182951440|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
91536190|NCT01549652|182951441|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
91536191|NCT01549652|182951442|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
91536192|NCT01549652|182951443|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91536193|NCT01549652|182951444|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91536194|NCT01549652|182951445|SUPERIORITY_OR_OTHER|||||||0.6||||||Students' t-test for paired samples were used to compare differences between the outcome measures for treatment groups (placebo vs. ondansetron).|t-test, 2 sided|||We aimed for a 20% change in OOWS score to show the treatment effect with a power of 80% and an alpha of 0.05, yielding a target of 23 patients per treatment group.||||0.6
91536195|NCT01549652|182951446|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
91536196|NCT01549652|182951447|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
91536197|NCT01549652|182951448|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.40
91536198|NCT01549652|182951449|SUPERIORITY_OR_OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
91536199|NCT01549652|182951450|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91536200|NCT01194258|182951453|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was set at 0.40.|LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.041||0.3876|TWO_SIDED|95.0|-0.12|0.05|||Mixed Models Analysis|||Approximately 110 participants were planned to be enrolled to allow approximately 88 participants to complete both treatment periods. Assuming a dropout rate of ≤20%, an intra-participant correlation of 0.80, a standard deviation of 1.2, and a true difference of 0, the study would have \>90% power to show that either Lispro-PH20 or Aspart-PH20 (each tested separately) was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.05|-0.12|0.3876
91536201|NCT03495713|182951471|OTHER||||||||||||||||||Descriptive analysis only based limited enrollments.|||
91536202|NCT00964119|182951476|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|90.0||||P-value \< .05 is the computed p-value for this measurement.|t-test, 2 sided|||PI and lead author left the institution before publishing data. Study has been closed and data files archived.||||<.05
91762412|NCT00620113|183416199|SUPERIORITY_OR_OTHER||Difference in LS Means|2.23|||<|0.001|TWO_SIDED|95.0|1.03|3.43||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.43|1.03|<0.001
91762413|NCT00620113|183416200|SUPERIORITY_OR_OTHER||Difference in LS Means|4.66|||<|0.001|TWO_SIDED|95.0|3.18|6.14||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.14|3.18|<0.001
91762414|NCT00620113|183416200|SUPERIORITY_OR_OTHER||Difference in LS Means|3.84|||<|0.001|TWO_SIDED|95.0|2.37|5.3||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||5.30|2.37|<0.001
91762415|NCT00620113|183416200|SUPERIORITY_OR_OTHER||Difference in LS Means|2.43||||0.002|TWO_SIDED|95.0|0.99|3.88||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.88|0.99|0.002
91762416|NCT00620113|183416201|SUPERIORITY_OR_OTHER||Difference in LS Means|-50.64|||<|0.001|TWO_SIDED|95.0|-66.43|-34.84||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-34.84|-66.43|<0.001
91762417|NCT00620113|183416201|SUPERIORITY_OR_OTHER||Difference in LS Means|-44.32|||<|0.001|TWO_SIDED|95.0|-60.42|-28.21||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-28.21|-60.42|<0.001
91762418|NCT00620113|183416201|SUPERIORITY_OR_OTHER||Difference in LS Means|-35.75|||<|0.001|TWO_SIDED|95.0|-52.33|-19.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-19.16|-52.33|<0.001
91762419|NCT00620113|183416202|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.42|||<|0.001|TWO_SIDED|95.0|-85.7|-35.13||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.13|-85.70|<0.001
91762420|NCT00620113|183416202|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.7|||<|0.001|TWO_SIDED|95.0|-85.91|-35.49||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.49|-85.91|<0.001
91762421|NCT00620113|183416202|SUPERIORITY_OR_OTHER||Difference in LS Means|-38.73|||<|0.001|TWO_SIDED|95.0|-65.94|-11.52||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-11.52|-65.94|<0.001
91762422|NCT00620113|183416203|SUPERIORITY_OR_OTHER||Difference in LS Means|-42.91|||<|0.001|TWO_SIDED|95.0|-65.55|-20.27||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-20.27|-65.55|<0.001
91762423|NCT00620113|183416203|SUPERIORITY_OR_OTHER||Difference in LS Means|-37.45||||0.001|TWO_SIDED|95.0|-60.32|-14.59||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-14.59|-60.32|0.001
91762424|NCT00620113|183416203|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.77||||0.017|TWO_SIDED|95.0|-50.37|-3.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-3.16|-50.37|0.017
91762425|NCT00620113|183416204|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.52|||<|0.001|TWO_SIDED|95.0|-25.11|-5.93||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-5.93|-25.11|<0.001
91762426|NCT00620113|183416204|SUPERIORITY_OR_OTHER||Difference in LS Means|-12.55||||0.009|TWO_SIDED|95.0|-22.16|-2.94||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-2.94|-22.16|0.009
91762427|NCT00620113|183416204|SUPERIORITY_OR_OTHER||Difference in LS Means|2.48||||0.598|TWO_SIDED|95.0|-7.79|12.74||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.74|-7.79|0.598
91762428|NCT00620113|183416205|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.86|||<|0.001|TWO_SIDED|95.0|-43.3|-10.42||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-10.42|-43.30|<0.001
91762429|NCT00620113|183416205|SUPERIORITY_OR_OTHER||Difference in LS Means|-28.86|||<|0.001|TWO_SIDED|95.0|-44.97|-12.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-12.75|-44.97|<0.001
91762430|NCT00620113|183416205|SUPERIORITY_OR_OTHER||Difference in LS Means|-5.61||||0.458|TWO_SIDED|95.0|-23.79|12.56||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.56|-23.79|0.458
91762431|NCT04072887|183416215|SUPERIORITY||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0235||0.628|TWO_SIDED|90.0|-0.027|0.05|||ANCOVA|||||0.050|-0.027|0.628
91762432|NCT04072887|183416215|SUPERIORITY||Least Squares Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.0144||0.425|TWO_SIDED|90.0|-0.012|0.035|||ANCOVA|||||0.035|-0.012|0.425
91536203|NCT02059980|182951477|SUPERIORITY||||||=|0.56|||||||Mixed Models Analysis|||It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||= 0.56
91536204|NCT02059980|182951478|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||=.98
91536205|NCT03412747|182951484|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|39.3|||||TWO_SIDED|95.0|30.9|47.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||47.7|30.9|
91536206|NCT03412747|182951484|SUPERIORITY||Odds Ratio (OR)|7.459|||<|0.001|TWO_SIDED|95.0|4.709|11.816||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.816|4.709|<0.001
91536207|NCT03412747|182951485|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|28.2|||||TWO_SIDED|95.0|19.7|36.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||36.7|19.7|
91536208|NCT03412747|182951485|SUPERIORITY||Odds Ratio (OR)|4.341|||<|0.001|TWO_SIDED|95.0|2.785|6.765||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||6.765|2.785|<0.001
91536209|NCT03412747|182951486|SUPERIORITY||Odds Ratio (OR)|6.231|||<|0.001|TWO_SIDED|95.0|3.515|11.046||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.046|3.515|<0.001
91536210|NCT03412747|182951486|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.657|9.041||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||9.041|3.657|<0.001
91536211|NCT03412747|182951487|SUPERIORITY||Odds Ratio (OR)|4.724|||<|0.001|TWO_SIDED|95.0|2.683|8.318||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.318|2.683|<0.001
91536212|NCT03412747|182951487|SUPERIORITY||Odds Ratio (OR)|4.762|||<|0.001|TWO_SIDED|95.0|3.014|7.523||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.523|3.014|<0.001
91536213|NCT03412747|182951488|SUPERIORITY||Odds Ratio (OR)|7.103|||<|0.001|TWO_SIDED|95.0|4.637|10.88||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||10.880|4.637|<0.001
91536214|NCT03412747|182951489|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.23|7.661||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||7.661|3.230|<0.001
91536215|NCT03412747|182951490|SUPERIORITY||Odds Ratio (OR)|5.249|||<|0.001|TWO_SIDED|95.0|3.207|8.593||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.593|3.207|<0.001
91536216|NCT03412747|182951490|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.257|7.594||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.594|3.257|<0.001
91762433|NCT04072887|183416215|SUPERIORITY||Least Squares Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.0174||0.463|TWO_SIDED|90.0|-0.016|0.041|||ANCOVA|||||0.041|-0.016|0.463
91762434|NCT04072887|183416215|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.0173||0.244|TWO_SIDED|90.0|-0.008|0.049|||ANCOVA|||||0.049|-0.008|0.244
91762435|NCT04072887|183416215|SUPERIORITY||Least Squares Mean Difference|0.005|STANDARD_ERROR_OF_MEAN|0.0176||0.793|TWO_SIDED|90.0|-0.024|0.034|||ANCOVA|||||0.034|-0.024|0.793
91762436|NCT01153724|183416244|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|113.29|STANDARD_DEVIATION|13.6||0.0101|TWO_SIDED|90.0|105.893|121.197||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||121.197|105.893|0.0101
91762437|NCT01153724|183416245|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|108.78|STANDARD_DEVIATION|15.5||0.0009|TWO_SIDED|90.0|101.59|116.487||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||116.487|101.590|0.0009
91762438|NCT01153724|183416245|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean|85.98|STANDARD_DEVIATION|19.4||0.0711|TWO_SIDED|90.0|79.277|93.253||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||93.253|79.277|0.0711
91762439|NCT01153724|183416248|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|114.83|STANDARD_DEVIATION|33.5||0.1539|TWO_SIDED|90.0|99.94|131.932||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||131.932|99.940|0.1539
91762440|NCT01153724|183416248|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.48|STANDARD_DEVIATION|1.068||0.8574|TWO_SIDED|90.0|66.619|83.266||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||83.266|66.619|0.8574
91762441|NCT01153724|183416249|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.08|STANDARD_DEVIATION|14.6||0.9646|TWO_SIDED|90.0|69.105|79.418||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||79.418|69.105|0.9646
91762442|NCT01979133|183416252|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||.012
91762443|NCT01979133|183416253|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.005
91762444|NCT01979133|183416254|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.017
91762445|NCT01979133|183416255|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.038
91762446|NCT01979133|183416256|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.034
91762447|NCT01979133|183416257|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.231
91762448|NCT01979133|183416258|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.066
91762449|NCT00486824|183416259|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
91762450|NCT04371666|183416286|OTHER||Least square (LS) Mean Difference|0.083|STANDARD_ERROR_OF_MEAN|0.5494||0.8802|TWO_SIDED|95.0|-1.01|1.176||Threshold for significance at 0.05 level.|Random coefficient model|||||1.176|-1.010|0.8802
91762451|NCT00445770|183416291|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Based on rank transformed data: rank of change = rank baseline+treatment +pooled study center+prior methotrexate use. If overall treatment effect statistically significant, 3 pairwise comparisons conducted, otherwise no further testing was made.|ANCOVA|||It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.||||<0.0001
91762452|NCT00445770|183416291|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
91762453|NCT00445770|183416291|NON_INFERIORITY_OR_EQUIVALENCE|An outcome showing that etanercept 10 mg was superior to methotrexate and the presence of numerical difference ≤0.5 mTSS units between etanercept 25 mg and etanercept 10 mg would support non-inferiority for the 2 etanercept treatments.||||||0.2634|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2634
91762454|NCT00445770|183416292|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
91762455|NCT00445770|183416292|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
91762456|NCT00445770|183416292|SUPERIORITY_OR_OTHER|||||||0.2248|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2248
91762457|NCT00445770|183416293|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
91762458|NCT00445770|183416293|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
91762459|NCT00445770|183416293|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.7260
91536217|NCT04982575|182951510|OTHER||Treatment difference|-0.3||||0.2284|TWO_SIDED|95.0|-0.79|0.19|||Mixed Models Analysis|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification.||0.19|-0.79|0.2284
91536218|NCT03038022|182951531|SUPERIORITY||Mean Difference (Net)|-18.8|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|-27.8|-9.8|||ANOVA|||LS mean difference in LDL-C between MGL-3196 and placebo.||-9.8|-27.8|<0.0001
91536219|NCT03038022|182951537|SUPERIORITY||Mean Difference (Net)|-19.5|STANDARD_ERROR_OF_MEAN|4.22|<|0.0001|TWO_SIDED|95.0|-27.9|-11.1|||ANOVA|||||-11.1|-27.9|<0.0001
91536220|NCT03038022|182951538|SUPERIORITY||Mean Difference (Net)|-25.4|STANDARD_ERROR_OF_MEAN|5.66|<|0.0001|TWO_SIDED|95.0|-36.7|-14.2|||ANOVA|||LS mean difference in triglycerides between MGL-3196 and placebo.||-14.2|-36.7|<0.0001
91536221|NCT03038022|182951539|SUPERIORITY||Mean Difference (Net)|-26.3|STANDARD_ERROR_OF_MEAN|5.01|<|0.0001|TWO_SIDED|95.0|-36.2|-16.4|||ANOVA|||LS mean difference in Lp(a) between MGL-3196 and placebo.||-16.4|-36.2|<0.0001
91536222|NCT03038022|182951540|SUPERIORITY||Mean Difference (Net)|-22.7|||<|0.0001|TWO_SIDED|95.0|-32.6|-12.8|||ANOVA|||||-12.8|-32.6|<0.0001
91536223|NCT03038022|182951541|SUPERIORITY||Mean Difference (Net)|-18.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-23.7|-12.2|||ANOVA|||LS mean difference in ApoB between MGL-3196 and placebo.||-12.2|-23.7|<0.0001
91536224|NCT03038022|182951542|SUPERIORITY||Mean Difference (Net)|-9.1||||0.0037|TWO_SIDED|95.0|-15.3|-3.0|||ANOVA|||||-3.0|-15.3|0.0037
91536225|NCT03038022|182951543|SUPERIORITY||Mean Difference (Net)|-9.8||||0.017|TWO_SIDED|95.0|-17.8|-1.8|||ANOVA|||||-1.8|-17.8|0.017
91536226|NCT03038022|182951544|SUPERIORITY||Mean Difference (Net)|-27.0|STANDARD_ERROR_OF_MEAN|5.79|<|0.0001|TWO_SIDED|95.0|-38.4|-15.5|||ANOVA|||||-15.5|-38.4|<0.0001
91536227|NCT03038022|182951546|SUPERIORITY||Mean Difference (Net)|-16.3|STANDARD_ERROR_OF_MEAN|5.25||0.0025|TWO_SIDED|95.0|-26.7|-5.9|||ANOVA|||||-5.9|-26.7|0.0025
91536228|NCT03038022|182951546|SUPERIORITY||Mean Difference (Net)|-21.2|STANDARD_ERROR_OF_MEAN|5.18|<|0.0001|TWO_SIDED|95.0|-31.4|-10.9|||ANOVA|||||-10.9|-31.4|<0.0001
91536229|NCT03038022|182951547|SUPERIORITY||Mean Difference (Net)|-245.2|||<|0.0001|TWO_SIDED|95.0|-363.7|-126.7|||ANOVA|||||-126.7|-363.7|<0.0001
91536230|NCT03038022|182951548|SUPERIORITY||Mean Difference (Net)|-99.4||||0.0067|TWO_SIDED|95.0|-170.6|-28.2|||ANOVA|||||-28.2|-170.6|0.0067
91762460|NCT00445770|183416293|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
91536231|NCT03038022|182951549|SUPERIORITY||Mean Difference (Net)|-14.7||||0.5245|TWO_SIDED|95.0|-60.5|31.0|||ANOVA|||||31.0|-60.5|0.5245
91536232|NCT03038022|182951550|SUPERIORITY||Mean Difference (Net)|-135.3||||0.0034|TWO_SIDED|95.0|-224.7|-45.8|||ANOVA|||||-45.8|-224.7|0.0034
91536233|NCT03038022|182951551|SUPERIORITY||Mean Difference (Net)|-10.0||||0.0129|TWO_SIDED|95.0|-17.9|-2.2|||ANOVA|||||-2.2|-17.9|0.0129
91536234|NCT03038022|182951552|SUPERIORITY||Mean Difference (Net)|-0.77||||0.3088|TWO_SIDED|95.0|-2.26|0.72|||ANOVA|||||0.72|-2.26|0.3088
91536235|NCT03038022|182951553|SUPERIORITY||Mean Difference (Net)|0.04||||0.6905|TWO_SIDED|95.0|-0.15|0.23|||ANOVA|||||0.23|-0.15|0.6905
91536236|NCT03038022|182951554|SUPERIORITY||Mean Difference (Net)|0.96||||0.5008|TWO_SIDED|95.0|-1.86|3.78|||ANOVA|||||3.78|-1.86|0.5008
91536237|NCT03038022|182951555|SUPERIORITY||Mean Difference (Net)|0.12||||0.1066|TWO_SIDED|95.0|-0.03|0.26|||ANOVA|||||0.26|-0.03|0.1066
91536238|NCT04269200|182951585|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.003|TWO_SIDED|95.0|0.57|0.89||Determined using a log-rank test stratified by mismatch repair (MMR) status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).|Regression, Cox|Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).|A hazard ratio less than 1 favours SoC + Durvalumab.|||0.89|0.57|0.003
91536239|NCT04269200|182951585|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.69||Determined using a log-rank test stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).|Regression, Cox|Model was stratified by MMR status (proficient versus deficient) and disease status (recurrent versus newly diagnosed).|A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.|||0.69|0.43|<0.0001
91536240|NCT04269200|182951585|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.42|1.25||China cohort designed to provide descriptive analysis only.|Regression, Cox|Model was stratified by disease status (recurrent versus newly diagnosed).|A hazard ratio less than 1 favours SoC + Durvalumab.|||1.25|0.42|
91536241|NCT04269200|182951585|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.57|1.61||China cohort designed to provide descriptive analysis only.|Regression, Cox|Model was stratified by disease status (recurrent versus newly diagnosed).|A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.|||1.61|0.57|
91536242|NCT04269200|182951587|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.59|1.07||Descriptive analysis only.|Regression, Cox|Model is unstratified.|A hazard ratio less than 1 favours SoC + Durvalumab.|||1.07|0.59|
91536243|NCT04269200|182951587|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.4|0.76||Descriptive analysis only.|Regression, Cox|Model is unstratified.|A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.|||0.76|0.40|
91536244|NCT04269200|182951587|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.48|2.21||China cohort designed to provide descriptive analysis only.|Regression, Cox|Model was stratified by disease status (recurrent versus newly diagnosed).|A hazard ratio less than 1 favours SoC + Durvalumab.|||2.21|0.48|
91536245|NCT04269200|182951587|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.68|2.9||China cohort designed to provide descriptive analysis only.|Regression, Cox|Model was stratified by disease status (recurrent versus newly diagnosed).|A hazard ratio less than 1 favours SoC + Durvalumab.|||2.90|0.68|
91536246|NCT04269200|182951588|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.89|1.98||Descriptive analysis only.|Regression, Logistic|Model was stratified by disease status (recurrent versus newly diagnosed).|An odds ratio greater than 1 favours SoC + durvalumab.|||1.98|0.89|
91762461|NCT00445770|183416293|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
91762462|NCT00445770|183416293|SUPERIORITY_OR_OTHER|||||||0.5717|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.5717
91762463|NCT00445770|183416294|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
91536247|NCT04269200|182951588|SUPERIORITY||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.95|2.18||Descriptive analysis only.|Regression, Logistic|Model was stratified by disease status (recurrent versus newly diagnosed).|An odds ratio greater than 1 favours SoC + durvalumab + Olaparib.|||2.18|0.95|
91536248|NCT04269200|182951595|SUPERIORITY||Least-squares Mean Difference|1.7|||||TWO_SIDED|95.0|-1.2|4.5||Descriptive analysis only.|Mixed model for repeated measures|Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.||||4.5|-1.2|
91536249|NCT04269200|182951595|SUPERIORITY||Least-squares Mean Difference|-0.6|||||TWO_SIDED|95.0|-3.4|2.2||Descriptive analysis only.|Mixed model for repeated measures|Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.||||2.2|-3.4|
91536250|NCT04269200|182951596|SUPERIORITY||Least-squares Mean Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.6||Descriptive analysis only.|Mixed model for repeated measures|Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.||||2.6|-2.5|
91536251|NCT04269200|182951596|SUPERIORITY||Least-squares Mean Difference|-0.9|||||TWO_SIDED|95.0|-3.4|1.6||Descriptive analysis only.|Mixed model for repeated measures|Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.||||1.6|-3.4|
91536252|NCT03887936|182951597|SUPERIORITY||Mean Difference (Final Values)|3.6|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||||||<0.05
91536253|NCT05824351|182951610|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|-0.2571|STANDARD_DEVIATION|0.7|<|0.0001|TWO_SIDED||||||t-test, 1 sided|One-sided lower t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||<0.0001
91536254|NCT05824351|182951610|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|0.0294|STANDARD_DEVIATION|0.79||0.0003|TWO_SIDED||||||t-test, 1 sided|One-sided upper t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||0.0003
91536255|NCT02912260|182951635|SUPERIORITY||Mean Difference (Net)|-22.5|STANDARD_ERROR_OF_MEAN|5.22|<|0.0001|TWO_SIDED|95.0|-32.9|-12.2|||ANCOVA|||LS mean difference in hepatic fat fraction between MGL-3196 and placebo at Week 12.||-12.2|-32.9|<0.0001
91536256|NCT02912260|182951637|SUPERIORITY||Mean Difference (Net)|-28.4|STANDARD_ERROR_OF_MEAN|6.52|<|0.0001|TWO_SIDED|95.0|-41.3|-15.4|||ANCOVA|||LS mean difference in hepatic fat fraction between MGL-3196 and placebo at Week 36.||-15.4|-41.3|<0.0001
91536257|NCT02912260|182951638|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|0.991|<|0.0001|TWO_SIDED|95.0|-6.3|-2.4|||ANCOVA|||LS mean difference in absolute hepatic fat fraction between MGL-3196 and placebo at Week 12.||-2.4|-6.3|<0.0001
91536258|NCT02912260|182951639|SUPERIORITY||Mean Difference (Net)|-5.3|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-7.8|-2.8|||ANCOVA|||LS mean difference in absolute hepatic fat fraction between MGL-3196 and placebo at Week 36.||-2.8|-7.8|<0.0001
91536259|NCT02912260|182951650|SUPERIORITY||Mean Difference (Net)|16.0|STANDARD_ERROR_OF_MEAN|31.81||0.6155|TWO_SIDED|95.0|-47.0|79.0|||Linear model|||LS mean difference in hsCRP between MGL-3196 and placebo at Week 12.||79.0|-47.0|0.6155
91536260|NCT02912260|182951651|SUPERIORITY||Mean Difference (Net)|56.9|STANDARD_ERROR_OF_MEAN|118.09||0.6311|TWO_SIDED|95.0|-177.4|291.1|||Linear model|||LS mean difference in hsCRP between MGL-3196 and placebo at Week 36.||291.1|-177.4|0.6311
91536261|NCT02912260|182951652|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|4.73||0.526|TWO_SIDED|95.0|-12.4|6.4|||Linear model|||LS mean difference in ALT between MGL-3196 and placebo at Week 12.||6.4|-12.4|0.5260
91536262|NCT02912260|182951653|SUPERIORITY||Mean Difference (Net)|-26.4|STANDARD_ERROR_OF_MEAN|8.29||0.0019|TWO_SIDED|95.0|-42.8|-9.9|||Linear model|||LS mean difference in ALT between MGL-3196 and placebo at Week 36.||-9.9|-42.8|0.0019
91536263|NCT02912260|182951654|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|3.1||0.1275|TWO_SIDED|95.0|-10.9|1.4|||Linear model|||LS mean difference in AST between MGL-3196 and placebo at Week 12.||1.4|-10.9|0.1275
91762464|NCT00445770|183416294|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0013
91762465|NCT00445770|183416294|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0186
91762466|NCT00445770|183416294|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
91762467|NCT00445770|183416294|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.0006
91762468|NCT00445770|183416294|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.1123
91762469|NCT00445770|183416295|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||<0.0001
91536264|NCT02912260|182951655|SUPERIORITY||Mean Difference (Net)|-11.1|STANDARD_ERROR_OF_MEAN|3.42||0.0016|TWO_SIDED|95.0|-17.8|-4.3|||Linear model|||LS mean difference in ALT between MGL-3196 and placebo at Week 36.||-4.3|-17.8|0.0016
91762470|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.0002
91762471|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.3022|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.3022
91762472|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0001
91762473|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0002
91762474|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.3120
91762475|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use.|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0010
91762476|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.0285|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0285
91762477|NCT00445770|183416295|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0433
91762478|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.0032|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0032
91762479|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762480|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.1224|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.1224
91762481|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762482|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762483|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.8037|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.8037
91762484|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91536265|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-12.9|STANDARD_ERROR_OF_MEAN|3.41||0.0002|TWO_SIDED|95.0|-19.6|-6.1|||Linear model|||LS mean difference in LDL-C between MGL-3196 and placebo at Week 12.||-6.1|-19.6|0.0002
91762485|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762486|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.5495|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5495
91762487|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762488|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762489|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.4948|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4948
91762490|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762491|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762492|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.4663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4663
91762493|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762494|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762495|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.9357|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9357
91762496|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762497|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762498|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.7439|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.7439
91762499|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762500|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762501|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.8611|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8611
91762502|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762503|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762504|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.6731|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.6731
91762505|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762506|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762507|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.2616|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.2616
91762508|NCT00445770|183416296|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762509|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
91762510|NCT00445770|183416296|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1158
91762511|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762512|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762513|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.4237
91762514|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762515|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0002
91762516|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.5738|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5738
91762517|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762518|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762519|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.1606|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1606
91762520|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91536266|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|3.33||0.3388|TWO_SIDED|95.0|-3.4|9.8|||Linear model|||LS mean difference in HDL-C between MGL-3196 and placebo at Week 12.||9.8|-3.4|0.3388
91762521|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0016
91762522|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.2412
91762523|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762524|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762525|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.5882|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5882
91762526|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762527|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0001
91762528|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.2257|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2257
91762529|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762530|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0003
91762531|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.2075|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2075
91762532|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762533|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0050
91762534|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0461|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0461
91762535|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0002
91762536|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0101
91762537|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.2351|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.2351
91762538|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
91762539|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.1179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1179
91762540|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0214
91762541|NCT00445770|183416297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762542|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0790
91762543|NCT00445770|183416297|SUPERIORITY_OR_OTHER|||||||0.0168|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0168
91762544|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762545|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762546|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.6337|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6337
91762547|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762548|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762549|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.7407|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.7407
91762550|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762551|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762552|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.3473|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.3473
91762553|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762554|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762555|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.7529|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7529
91762556|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762557|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762558|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5216
91762559|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762560|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762561|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1078
91762562|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762563|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762564|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.1280
91762565|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762566|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762567|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0291
91762568|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762569|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762570|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0729
91762571|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762572|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762573|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.0271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0271
91762574|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762575|NCT00445770|183416298|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762576|NCT00445770|183416298|SUPERIORITY_OR_OTHER|||||||0.0453|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0453
91762577|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762578|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762579|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.7488|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.7488
91762580|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762581|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762582|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5680
91762583|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762584|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762585|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.9241|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9241
91762586|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762587|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762588|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7146
91762589|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762590|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
91762591|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.6574
91762592|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762593|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0004
91762594|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.2936|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2936
91762595|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762596|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0005
91762597|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2179
91762598|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762599|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762600|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.3704|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.3704
91762601|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762602|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762603|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.8047|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.8047
91762604|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762605|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762606|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.5277|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5277
91762607|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762608|NCT00445770|183416299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762609|NCT00445770|183416299|SUPERIORITY_OR_OTHER|||||||0.9371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9371
91762610|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0027
91762611|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0015
91762612|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.8875|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8875
91762613|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0015
91762614|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0011
91762615|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.9694|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.9694
91762616|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0020
91762617|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0005
91762618|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.7271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.7271
91762619|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0235|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0235
91762620|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0061
91762621|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.6427|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.6427
91762622|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0036
91762623|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0029
91762624|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.9713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.9713
91762625|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
91762626|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
91762627|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.9762|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9762
91762628|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0554|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0554
91762629|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0181|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0181
91762630|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.6642|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6642
91762631|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0073
91762632|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0290
91762633|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.5919|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.5919
91762634|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0371
91762635|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0346
91762636|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.9955|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.9955
91762637|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0187|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0187
91762638|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0645|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0645
91762639|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5920
91762640|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0095
91762641|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.2112|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.2112
91762642|NCT00445770|183416300|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1649
91762643|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762644|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762645|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.8972|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8972
91762646|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762647|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762648|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.3736|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.3736
91762649|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762650|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762651|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.9324|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9324
91762652|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762653|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762654|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.8982|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.8982
91762655|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762656|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0007
91762657|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.3180
91762658|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762659|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0011
91762660|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.3302|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.3302
91762661|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762662|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0002
91762663|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.6563|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6563
91762664|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762665|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762666|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.8894|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8894
91762667|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762668|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762669|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.7826|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7826
91762670|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91513638|NCT03893448|182899004|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.5|-4.3|< 0.001
91513639|NCT03893448|182899005|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.89|< 0.001
91513640|NCT03893448|182899005|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.98|||<|0.001|TWO_SIDED|95.0|0.87|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.87|< 0.001
91513641|NCT03893448|182899005|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.28|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.28|0.91|< 0.001
91513642|NCT03893448|182899005|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.84|< 0.001
91513643|NCT03893448|182899006|NON_INFERIORITY|A conclusion of non-inferiority of VAQTA™ administered concomitantly with V114 to VAQTA™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-1.6|2.2||p value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||2.2|-1.6|< 0.001
91513644|NCT03893448|182899007|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.8|1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.3|-1.8|< 0.001
91513645|NCT03893448|182899007|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.8|0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.2|-3.8|< 0.001
91513646|NCT03893448|182899007|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.3|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-2.3|< 0.001
91513647|NCT03893448|182899008|NON_INFERIORITY|A conclusion of non-inferiority of VARIVAX™ administered concomitantly with V114 to VARIVAX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-3.2|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-3.2|< 0.001
91513648|NCT03893448|182899009|NON_INFERIORITY|A conclusion of non-inferiority of HIBERIX™ administered concomitantly with V114 to HIBERIX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.2|-0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||-0.5|-2.2|< 0.001
91513649|NCT03893448|182899010|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|92.03|||<|0.001|TWO_SIDED|95.0|83.47|101.47|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||101.47|83.47|< 0.001
91762671|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0003
91762672|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.5343|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5343
91762673|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762674|NCT00445770|183416301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762675|NCT00445770|183416301|SUPERIORITY_OR_OTHER|||||||0.9313|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9313
91762676|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762677|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762678|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.8044|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8044
91762679|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762680|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0003
91513650|NCT03893448|182899010|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|29.5|||<|0.001|TWO_SIDED|95.0|26.16|33.26|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||33.26|26.16|< 0.001
91762681|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4652
91762682|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762683|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762684|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.5612|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5612
91762685|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
91762686|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
91762687|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.9749|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.9749
91762688|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
91762689|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0004
91762690|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.7290
91762691|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762692|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0003
91762693|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.5004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.5004
91762694|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762695|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762696|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.5727|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.5727
91762697|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762698|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762699|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.6713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.6713
91762700|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91762701|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0001
91762702|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.7663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7663
91762703|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762704|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
91762705|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.7073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.7073
91762706|NCT00445770|183416302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762707|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
91762708|NCT00445770|183416302|SUPERIORITY_OR_OTHER|||||||0.7973|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.7973
91762709|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
91762710|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
91762711|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.1053|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.1053
91762712|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
91536267|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-13.4|STANDARD_ERROR_OF_MEAN|3.02|<|0.0001|TWO_SIDED|95.0|-19.3|-7.4|||Linear model|||LS mean difference in non-HDL-C between MGL-3196 and placebo at Week 12.||-7.4|-19.3|<0.0001
91762713|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
91762714|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0144
91762715|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
91762716|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
91762717|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.1851|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.1851
91762718|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
91762719|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0001
91762720|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.2883|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.2883
91762721|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
91762722|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.0007
91762723|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.2221|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.2221
91762724|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
91762725|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0147
91762726|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0201|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0201
91762727|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
91762728|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0036
91762729|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0789
91762730|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
91762731|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0008
91762732|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.1903|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1903
91762733|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
91762734|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0048
91762735|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.1059|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1059
91762736|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
91762737|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0018
91762738|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.2589
91762739|NCT00445770|183416303|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
91762740|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0040
91762741|NCT00445770|183416303|SUPERIORITY_OR_OTHER|||||||0.2326|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.2326
91762742|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
91762743|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
91762744|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.4751|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4751
91762745|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
91762746|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
91762747|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.4653|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.4653
91513651|NCT03893448|182899011|SUPERIORITY||Percentage Point Difference|95.1|||<|0.001|TWO_SIDED|95.0|93.1|96.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||96.5|93.1|< 0.001
91536268|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-9.6|STANDARD_ERROR_OF_MEAN|2.39||0.0001|TWO_SIDED|95.0|-14.3|-4.9|||Linear model|||LS mean difference in TC between MGL-3196 and placebo at Week 12.||-4.9|-14.3|0.0001
91762748|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
91762749|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
91762750|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.7953|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7953
91762751|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
91762752|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
91762753|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.0848|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0848
91762754|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
91762755|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
91762756|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.6112|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.6112
91762757|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
91762758|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0002
91762759|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.3671
91762760|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
91762761|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
91762762|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.7618|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7618
91762763|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
91762764|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
91762765|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.4358|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4358
91762766|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0008
91762767|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
91762768|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.6267|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.6267
91762769|NCT00445770|183416304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
91762770|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0004
91762771|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.3564|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.3564
91762772|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0007
91762773|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0035
91762774|NCT00445770|183416304|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.4749
91762775|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
91762776|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0001
91762777|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.4376|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4376
91762778|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
91762779|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
91762780|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.3947|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.3947
91762781|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
91762782|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
91762783|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.7378|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7378
91762784|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0001
91762785|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
91762786|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.5680
91762787|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0003
91762788|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
91762789|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.3978|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.3978
91762790|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
91762791|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0001
91762792|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.7229|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.7229
91762793|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
91762794|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
91762795|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.7236|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7236
91762796|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
91762797|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
91762798|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.9719|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.9719
91762799|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
91762800|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
91762801|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.9349|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.9349
91762802|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
91762803|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0002
91762804|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.7226|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.7226
91762805|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
91762806|NCT00445770|183416305|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
91762807|NCT00445770|183416305|SUPERIORITY_OR_OTHER|||||||0.5512|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.5512
91762808|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0162
91762809|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0035
91762810|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.8928|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.8928
91513652|NCT03893448|182899011|SUPERIORITY||Percentage Point Difference|85.2|||<|0.001|TWO_SIDED|95.0|82.3|87.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||87.7|82.3|< 0.001
91513653|NCT03893448|182899012|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|68.8|||<|0.001|TWO_SIDED|95.0|63.1|75.02|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||75.02|63.10|< 0.001
91513654|NCT03893448|182899012|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|44.91|||<|0.001|TWO_SIDED|95.0|41.04|49.14|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||49.14|41.04|< 0.001
91513655|NCT03893448|182899015|SUPERIORITY||Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
91513656|NCT03893448|182899016|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
91513657|NCT03893448|182899017|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
91513658|NCT03321019|182899041|OTHER||F-statistic|8.59|||<|0.0001|TWO_SIDED|||||The p value was adjusted for multiple comparisons using Tukey's method.|ANOVA|Degree of freedom - 3, 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||<.0001
91513659|NCT03321019|182899042|OTHER||F-statistic|0.44||||0.72|TWO_SIDED|||||Tukey's method was used to control for multiple comparisons.|ANOVA|Degrees of freedom - 3. 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.72
91513660|NCT03321019|182899043|OTHER||F-statistic|3.048||||0.02|TWO_SIDED|||||Dunnett's T3 method was used to account for multiple comparisons.|ANOVA|degrees of freedom: 3, 229||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.02
91513661|NCT03321019|182899044|OTHER||F-statistic|2.939||||0.034|TWO_SIDED|||||The p value was adjusted in the analysis for multiple comparisons using Tukey's method.|ANOVA|Degrees of freedom - 3, 231||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.034
91513662|NCT03321019|182899045|OTHER||F-statistic|1.494||||0.022|TWO_SIDED|||||Tukey's method was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom - 3, 274||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.022
91513663|NCT03880578|182899046|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|The outcome measure is change over time between treatment groups, reported as a mean adjusted difference.|change in the composite score of the ThyPRO between groups|||-5.7|-14.9|<0.001
91513664|NCT03880578|182899047|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.06|TWO_SIDED|95.0|-4.34|0.06|||Mixed Models Analysis|||||0.06|-4.34|0.06
91513665|NCT03880578|182899048|SUPERIORITY||Median Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.27|2.03|||Mixed Models Analysis||MAD obtained after log transformation of TSH|||2.03|1.27|<0.001
91513666|NCT03880578|182899049|SUPERIORITY||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Mixed Models Analysis|||FT3||-0.35|-0.87|<0.001
91513667|NCT03880578|182899049|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.12|TWO_SIDED|95.0|-1.81|0.15|||Mixed Models Analysis|||FT4||0.15|-1.81|0.12
91513668|NCT03880578|182899050|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-14.6|-8.5|||Mixed Models Analysis|||||-8.5|-14.6|<0.001
91513669|NCT03056690|182899059|SUPERIORITY|Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (Week 8) as response; treatment, center (pooled where necessary), time (week 8) and treatment\*time as fixed effects, baseline and baseline\*time as covariates.|LSMean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.25||0.086|TWO_SIDED|90.0|-0.76|0.07|||MMRM|||||0.07|-0.76|0.086
91513670|NCT03056690|182899065|SUPERIORITY||Difference|0.2||||0.551|TWO_SIDED|90.0|-11.9|12.5|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||12.5|-11.9|0.551
91513671|NCT03056690|182899066|SUPERIORITY||Difference|6.9||||0.202|TWO_SIDED|90.0|-5.2|19.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||19.1|-5.2|0.202
91513672|NCT03056690|182899067|SUPERIORITY||Difference|1.7||||0.451|TWO_SIDED|90.0|-10.5|13.8|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||13.8|-10.5|0.451
91513673|NCT03056690|182899068|SUPERIORITY||Difference|6.1||||0.174|TWO_SIDED|90.0|-6.2|18.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||18.1|-6.2|0.174
91536269|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-16.6|STANDARD_ERROR_OF_MEAN|7.35||0.0258|TWO_SIDED|95.0|-31.2|-2.0|||Linear model|||LS mean difference in TG between MGL-3196 and placebo at Week 12.||-2.0|-31.2|0.0258
91536270|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-15.3|STANDARD_ERROR_OF_MEAN|2.76|<|0.0001|TWO_SIDED|95.0|-20.8|-9.9|||Linear model|||LS mean difference in ApoB between MGL-3196 and placebo at Week 12.||-9.9|-20.8|<0.0001
91536271|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|5.64||0.0021|TWO_SIDED|95.0|-28.9|-6.6|||Linear model|||LS mean difference in ApoCIII between MGL-3196 and placebo at Week 12.||-6.6|-28.9|0.0021
91536272|NCT02912260|182951656|SUPERIORITY||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|13.06||0.1123|TWO_SIDED|95.0|-46.8|5.0|||ANOVA|||LS mean difference in Lp(a) between MGL-3196 and placebo at Week 12.||5.0|-46.8|0.1123
91536273|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0013|TWO_SIDED|95.0|-19.9|-5.0|||Linear model|||LS mean difference in LDL-C between MGL-3196 and placebo at Week 36.||-5.0|-19.9|0.0013
91536274|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|6.56||0.8213|TWO_SIDED|95.0|-14.5|11.5|||Linear model|||LS mean difference in HDL-C between MGL-3196 and placebo at Week 36.||11.5|-14.5|0.8213
91536275|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-16.1|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|-22.7|-9.4|||Linear model|||LS mean difference in nonHDL-C between MGL-3196 and placebo at Week 36.||-9.4|-22.7|<0.0001
91536276|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-12.5|STANDARD_ERROR_OF_MEAN|2.83|<|0.0001|TWO_SIDED|95.0|-18.1|-6.9|||Linear model|||LS mean difference in TC between MGL-3196 and placebo at Week 36.||-6.9|-18.1|<0.0001
91536277|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-37.3|STANDARD_ERROR_OF_MEAN|7.58|<|0.0001|TWO_SIDED|95.0|-52.3|-22.3|||Linear model|||LS mean difference in TG between MGL-3196 and placebo at Week 36.||-22.3|-52.3|<0.0001
91536278|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-17.4|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-23.6|-11.2|||Linear model|||LS mean difference in ApoB between MGL-3196 and placebo at Week 36.||-11.2|-23.6|<0.0001
91762811|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0009
91536279|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-36.5|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|-49.6|-23.5|||Linear model|||LS mean difference in ApoCIII between MGL-3196 and placebo at Week 36.||-23.5|-49.6|<0.0001
91536280|NCT02912260|182951657|SUPERIORITY||Mean Difference (Net)|-20.0|STANDARD_ERROR_OF_MEAN|19.24||0.3008|TWO_SIDED|95.0|-58.2|18.2|||ANOVA|||LS mean difference in Lp(a) between MGL-3196 and placebo at Week 36.||18.2|-58.2|0.3008
91536281|NCT02912260|182951658|SUPERIORITY||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|13.06||0.1123|TWO_SIDED|95.0|-46.8|5.0|||Linear model|||LS mean difference in Lp(a) between MGL-3196 and placebo at Week 12.||5.0|-46.8|0.1123
91536282|NCT02912260|182951659|SUPERIORITY||Mean Difference (Net)|-20.0|STANDARD_ERROR_OF_MEAN|19.24||0.3008|TWO_SIDED|95.0|-58.2|18.2|||Linear model|||LS mean difference in Lp(a) between MGL-3196 and placebo at Week 36.||18.2|-58.2|0.3008
91536283|NCT02912260|182951660|SUPERIORITY||Mean Difference (Net)|-58.75|STANDARD_ERROR_OF_MEAN|61.551||0.3419|TWO_SIDED|95.0|-180.7|63.21|||Linear model|||LS mean difference in CK-18 between MGL-3196 and placebo at Week 12.||63.21|-180.70|0.3419
91762812|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0007
91762813|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.6348|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.6348
91762814|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.0026
91762815|NCT00445770|183416306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
91762816|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.4629|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.4629
91536284|NCT02912260|182951660|SUPERIORITY||Mean Difference (Net)|-171.24|STANDARD_ERROR_OF_MEAN|57.423||0.0035|TWO_SIDED|95.0|-285.06|-57.42|||Linear model|||LS mean difference in CK-18 between MGL-3196 and placebo at Week 36.||-57.42|-285.06|0.0035
91536285|NCT02912260|182951661|SUPERIORITY||Mean Difference (Net)|-0.395|STANDARD_ERROR_OF_MEAN|0.1458||0.0089|TWO_SIDED|95.0|-0.686|-0.103|||Linear model|||LS mean difference in ELF-test between MGL-3196 and placebo at Week 12.||-0.103|-0.686|0.0089
91536286|NCT02912260|182951661|SUPERIORITY||Mean Difference (Net)|-0.484|STANDARD_ERROR_OF_MEAN|0.1973||0.0174|TWO_SIDED|95.0|-0.879|-0.088|||Linear model|||LS mean difference in ELF test between MGL-3196 and placebo at Week 36.||-0.088|-0.879|0.0174
91536287|NCT03878446|182951692|SUPERIORITY||Treatment difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4||||||||0.4|-3.2|
91536288|NCT03878446|182951692|SUPERIORITY||Treatment difference|0.7|||||TWO_SIDED|95.0|-1.1|2.5||||||||2.5|-1.1|
91536289|NCT03878446|182951692|SUPERIORITY||Treatment difference|-0.9|||||TWO_SIDED|95.0|-2.6|0.9||||||||0.9|-2.6|
91536290|NCT03878446|182951692|SUPERIORITY||Treatment difference|-0.6|||||TWO_SIDED|95.0|-2.4|1.2||||||||1.2|-2.4|
91536291|NCT03370133|182951705|SUPERIORITY||Odds Ratio (OR)|99.869|||<|0.001|TWO_SIDED|95.0|34.02|293.175||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||293.175|34.020|<0.001
91536292|NCT03370133|182951705|SUPERIORITY||Odds Ratio (OR)|6.056|||<|0.001|TWO_SIDED|95.0|3.874|9.466||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||9.466|3.874|<0.001
91762817|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0841
91762818|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0007
91536293|NCT03370133|182951706|SUPERIORITY||Odds Ratio (OR)|118.762|||<|0.001|TWO_SIDED|95.0|36.701|384.307||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||384.307|36.701|<0.001
91536294|NCT03370133|182951706|SUPERIORITY||Odds Ratio (OR)|4.809|||<|0.001|TWO_SIDED|95.0|3.096|7.47||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||7.470|3.096|<0.001
91536295|NCT03370133|182951707|SUPERIORITY||Odds Ratio (OR)|25.59|||<|0.001|TWO_SIDED|95.0|9.063|72.253||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||72.253|9.063|<0.001
91536296|NCT03370133|182951708|SUPERIORITY||Odds Ratio (OR)|25.471|||<|0.001|TWO_SIDED|95.0|9.02|71.925||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||71.925|9.020|<0.001
91536297|NCT03370133|182951709|SUPERIORITY||Odds Ratio (OR)|123.02|||<|0.001|TWO_SIDED|95.0|29.394|514.862||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||514.862|29.394|<0.001
91536298|NCT03370133|182951709|SUPERIORITY||Odds Ratio (OR)|18.202|||<|0.001|TWO_SIDED|95.0|10.998|30.123||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||30.123|10.998|<0.001
91762819|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.1957|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.1957
91536299|NCT03370133|182951710|SUPERIORITY||Odds Ratio (OR)|16.258|||<|0.001|TWO_SIDED|95.0|7.356|35.931||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||35.931|7.356|<0.001
91536300|NCT03370133|182951711|SUPERIORITY||Odds Ratio (OR)|22.279|||<|0.001|TWO_SIDED|95.0|9.795|50.674||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||50.674|9.795|<0.001
91536301|NCT03370133|182951712|SUPERIORITY||Odds Ratio (OR)|23.049|||<|0.001|TWO_SIDED|95.0|10.201|52.077||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||52.077|10.201|<0.001
91536302|NCT03370133|182951713|SUPERIORITY||Odds Ratio (OR)|37.696|||<|0.001|TWO_SIDED|95.0|16.92|83.987||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||83.987|16.920|<0.001
91536303|NCT03370133|182951714|SUPERIORITY||Odds Ratio (OR)|8.047|||<|0.001|TWO_SIDED|95.0|5.107|12.679||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||12.679|5.107|<0.001
91762820|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0093
91536304|NCT03370133|182951715|SUPERIORITY||Odds Ratio (OR)|3.795|||<|0.001|TWO_SIDED|95.0|2.442|5.899||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.899|2.442|<0.001
91536305|NCT03370133|182951716|SUPERIORITY||Odds Ratio (OR)|4.379|||<|0.001|TWO_SIDED|95.0|2.85|6.73||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||6.730|2.850|<0.001
91762821|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0326|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0326
91762822|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.7426|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.7426
91762823|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0013
91762824|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0015
91762825|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.6552|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.6552
91762826|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0005
91536306|NCT03370133|182951717|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|95.0|1.573|3.699||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.699|1.573|<0.001
91536307|NCT02501811|182951728|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.05||0.993|TWO_SIDED|95.0|-2.19|2.023|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||2.023|-2.190|0.993
91536308|NCT02501811|182951728|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.96||0.499|TWO_SIDED|95.0|-1.229|2.635|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.229|0.499
91536309|NCT02501811|182951728|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.05||0.578|TWO_SIDED|95.0|-0.729|3.485|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.485|-0.729|0.578
91536310|NCT02501811|182951728|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.04||0.523|TWO_SIDED|95.0|-3.552|0.629|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||0.629|-3.552|0.523
91536311|NCT02501811|182951728|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.95||0.471|TWO_SIDED|95.0|-2.7|1.127|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.127|-2.7|0.471
91536312|NCT02501811|182951728|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.95||0.485|TWO_SIDED|95.0|-1.24|2.59|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.590|-1.240|0.485
91536313|NCT02501811|182951729|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.05||0.942|TWO_SIDED|95.0|-2.406|1.887|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||1.887|-2.406|0.942
91536314|NCT02501811|182951729|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|1.17||0.282|TWO_SIDED|95.0|-1.815|2.975|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.975|-1.815|0.282
91762827|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0004
91762828|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.6294|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.6294
91536315|NCT02501811|182951729|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.95||0.163|TWO_SIDED|95.0|-1.31|2.635|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.310|0.163
91536316|NCT02501811|182951729|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.77||0.175|TWO_SIDED|95.0|-2.471|0.628|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.628|-2.471|0.175
91536317|NCT02501811|182951729|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.03||0.329|TWO_SIDED|95.0|-2.932|1.254|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.254|-2.932|0.329
91536318|NCT02501811|182951729|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.93||0.752|TWO_SIDED|95.0|-1.829|1.994|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.994|-1.829|0.752
91536319|NCT02501811|182951730|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.75||0.733|TWO_SIDED|95.0|-1.118|1.927|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.927|-1.118|0.733
91536320|NCT02501811|182951730|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.735|TWO_SIDED|95.0|-1.248|2.041|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.041|-1.248|0.735
91536321|NCT02501811|182951730|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.8||0.794|TWO_SIDED|95.0|-1.464|1.767|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.767|-1.464|0.794
91536322|NCT02501811|182951730|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.7||0.951|TWO_SIDED|95.0|-1.161|1.666|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.666|-1.161|0.951
91536323|NCT02501811|182951730|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.71||0.962|TWO_SIDED|95.0|-1.441|1.457|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.441|0.962
91536324|NCT02501811|182951730|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.76||0.945|TWO_SIDED|95.0|-1.793|1.303|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.303|-1.793|0.945
91762829|NCT00445770|183416306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
91762830|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.0001
91536325|NCT02501811|182951731|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|3.85||0.602|TWO_SIDED|95.0|-9.754|5.711|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.711|-9.754|0.602
91536326|NCT02501811|182951731|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|3.39||0.443|TWO_SIDED|95.0|-9.609|4.044|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.044|-9.609|0.443
91536327|NCT02501811|182951731|SUPERIORITY||Mean Difference (Net)|-4.13|STANDARD_ERROR_OF_MEAN|3.42||0.348|TWO_SIDED|95.0|-11.011|2.76|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.760|-11.011|0.348
91536328|NCT02501811|182951731|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|3.92||0.812|TWO_SIDED|95.0|-5.76|9.968|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.968|-5.760|0.812
91536329|NCT02501811|182951731|SUPERIORITY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|3.89||0.9|TWO_SIDED|95.0|-7.052|8.574|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.574|-7.052|0.900
91536330|NCT02501811|182951731|SUPERIORITY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|3.47||0.848|TWO_SIDED|95.0|-8.321|5.635|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.635|-8.321|0.848
91536331|NCT02501811|182951732|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|3.01||0.659|TWO_SIDED|95.0|-7.281|4.789|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.789|-7.281|0.659
91536332|NCT02501811|182951732|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|3.06||0.466|TWO_SIDED|95.0|-8.621|3.71|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.710|-8.621|0.466
91536333|NCT02501811|182951732|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|3.08||0.293|TWO_SIDED|95.0|-10.799|1.594|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.594|-10.799|0.293
91536334|NCT02501811|182951732|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|3.06||0.53|TWO_SIDED|95.0|-2.795|9.508|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.508|-2.795|0.530
91536335|NCT02501811|182951732|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|3.05||0.761|TWO_SIDED|95.0|-4.91|7.33|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||7.330|-4.910|0.761
91536336|NCT02501811|182951732|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|3.12||0.669|TWO_SIDED|95.0|-8.426|4.132|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.132|-8.426|0.669
91536337|NCT02501811|182951733|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.989|TWO_SIDED|95.0|-0.048|0.04|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.040|-0.048|0.989
91536338|NCT02501811|182951733|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.493|TWO_SIDED|95.0|-0.056|0.033|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.033|-0.056|0.493
91536339|NCT02501811|182951733|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.926|TWO_SIDED|95.0|-0.053|0.039|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.039|-0.053|0.926
91536340|NCT02501811|182951733|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.904|TWO_SIDED|95.0|-0.041|0.047|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.047|-0.041|0.904
91536341|NCT02501811|182951733|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.476|TWO_SIDED|95.0|-0.035|0.049|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.049|-0.035|0.476
91536342|NCT02501811|182951733|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.515|TWO_SIDED|95.0|-0.04|0.048|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.048|-0.040|0.515
91536343|NCT02501811|182951734|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.85||0.569|TWO_SIDED|95.0|-1.77|1.687|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.687|-1.770|0.569
91536344|NCT02501811|182951734|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.8||0.767|TWO_SIDED|95.0|-1.792|1.457|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.792|0.767
91536345|NCT02501811|182951734|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.71||0.261|TWO_SIDED|95.0|-1.965|0.921|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.921|-1.965|0.261
91536346|NCT02501811|182951734|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.86||0.587|TWO_SIDED|95.0|-1.261|2.222|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.222|-1.261|0.587
91536347|NCT02501811|182951734|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.93||0.994|TWO_SIDED|95.0|-1.763|2.014|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.014|-1.763|0.994
91536348|NCT02501811|182951734|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.81||0.639|TWO_SIDED|95.0|-1.993|1.283|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.283|-1.993|0.639
91536349|NCT02501811|182951735|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.42||0.992|TWO_SIDED|95.0|-2.437|3.319|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.319|-2.437|0.992
91536350|NCT02501811|182951735|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.22||0.862|TWO_SIDED|95.0|-2.278|2.643|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.643|-2.278|0.862
91536351|NCT02501811|182951735|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.31||0.217|TWO_SIDED|95.0|-3.846|1.443|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.443|-3.846|0.217
91536352|NCT02501811|182951735|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.47||0.327|TWO_SIDED|95.0|-1.325|4.611|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||4.611|-1.325|0.327
91536353|NCT02501811|182951735|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.39||0.859|TWO_SIDED|95.0|-2.551|3.068|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.068|-2.551|0.859
91536354|NCT02501811|182951735|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.27||0.338|TWO_SIDED|95.0|-3.952|1.184|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.184|-3.952|0.338
91536355|NCT02501811|182951736|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.71||0.157|TWO_SIDED|95.0|-2.456|0.411|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.411|-2.456|0.157
91536356|NCT02501811|182951736|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.9||0.428|TWO_SIDED|95.0|-2.798|0.859|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.859|-2.798|0.428
91536357|NCT02501811|182951736|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.73||0.382|TWO_SIDED|95.0|-0.83|2.093|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.093|-0.83|0.382
91536358|NCT02501811|182951736|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.8||0.056|TWO_SIDED|95.0|-3.255|-0.052|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.052|-3.255|0.056
91536359|NCT02501811|182951736|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.96||0.61|TWO_SIDED|95.0|-1.991|1.885|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.885|-1.991|0.610
91536360|NCT02501811|182951736|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.356|3.557|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.557|-0.356|0.195
91536361|NCT02501811|182951737|SUPERIORITY||Mean Difference (Final Values)|18.57|STANDARD_ERROR_OF_MEAN|19.01||0.348|TWO_SIDED|95.0|-19.537|56.687|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||56.687|-19.537|0.348
91536362|NCT02501811|182951737|SUPERIORITY||Mean Difference (Final Values)|23.19|STANDARD_ERROR_OF_MEAN|17.88||0.23|TWO_SIDED|95.0|-12.759|59.134|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||59.134|-12.759|0.230
91536363|NCT02501811|182951737|SUPERIORITY||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|16.21||0.905|TWO_SIDED|95.0|-30.974|34.361|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||34.361|-30.974|0.905
91536364|NCT02501811|182951737|SUPERIORITY||Mean Difference (Final Values)|16.88|STANDARD_ERROR_OF_MEAN|15.98||0.335|TWO_SIDED|95.0|-15.267|49.03|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||49.030|-15.267|0.335
91536365|NCT02501811|182951737|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|17.68||0.827|TWO_SIDED|95.0|-40.106|30.88|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||30.880|-40.106|0.827
91536366|NCT02501811|182951737|SUPERIORITY||Mean Difference (Final Values)|-21.49|STANDARD_ERROR_OF_MEAN|14.63||0.163|TWO_SIDED|95.0|-50.989|8.001|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.001|-50.989|0.163
91536367|NCT02501811|182951738|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.63||0.023|TWO_SIDED|95.0|-18.915|-0.357|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.357|-18.915|0.023
91536368|NCT02501811|182951738|SUPERIORITY||Mean Difference (Final Values)|-15.09|STANDARD_ERROR_OF_MEAN|5.84||0.05|TWO_SIDED|95.0|-26.871|-3.319|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-3.319|-26.871|0.050
91536369|NCT02501811|182951738|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|5.86||0.119|TWO_SIDED|95.0|-14.784|8.836|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.836|-14.784|0.119
91762831|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4652
91762832|NCT00445770|183416306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
91762833|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0002
91762834|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.2233|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.2233
91762835|NCT00445770|183416306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
91762836|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0003
91762837|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.6772|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.6772
91762838|NCT00445770|183416306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
91762839|NCT00445770|183416306|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
91762840|NCT00445770|183416306|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.6160
91762841|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
91762842|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
91762843|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.4929|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.4929
91513674|NCT03056690|182899069|SUPERIORITY||Least Square (LS) Mean difference|-1.48|STANDARD_ERROR_OF_MEAN|2.04||0.235|TWO_SIDED|90.0|-4.86|1.9||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 2||1.90|-4.86|0.235
91762844|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
91762845|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
91513675|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-2.97|STANDARD_ERROR_OF_MEAN|2.34||0.103|TWO_SIDED|90.0|-6.84|0.89||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 4||0.89|-6.84|0.103
91762846|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.9693|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.9693
91762847|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
91762848|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
91762849|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.4139|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.4139
91762850|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
91762851|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
91762852|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.8905|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.8905
91762853|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
91762854|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
91762855|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.6877|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.6877
91762856|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
91762857|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
91762858|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.4511|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.4511
91762859|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
91762860|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
91762861|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.2786
91762862|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
91536370|NCT02501811|182951738|SUPERIORITY||Mean Difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|5.66||0.845|TWO_SIDED|95.0|-18.087|4.762|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.762|-18.087|0.845
91762863|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
91762864|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1230
91762865|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
91762866|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
91762867|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.5061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.5061
91762868|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
91762869|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
91762870|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.1354|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.1354
91762871|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
91762872|NCT00445770|183416307|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
91762873|NCT00445770|183416307|SUPERIORITY_OR_OTHER|||||||0.1734|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1734
91762874|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762875|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
91762876|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.6417|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6417
91762877|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91762878|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
91513676|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.53||0.154|TWO_SIDED|90.0|-6.78|1.6||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 8||1.60|-6.78|0.154
91762879|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.4698|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4698
91762880|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762881|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
91762882|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.1214|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1214
91762883|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762884|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
91762885|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.4654|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4654
91762886|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762887|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
91762888|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.4006|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4006
91762889|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762890|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
91762891|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.1636|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1636
91762892|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91762893|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
91536371|NCT02501811|182951738|SUPERIORITY||Mean Difference (Final Values)|5.46|STANDARD_ERROR_OF_MEAN|5.64||0.976|TWO_SIDED|95.0|-5.931|16.848|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||16.848|-5.931|0.976
91536372|NCT02501811|182951738|SUPERIORITY||Mean Difference (Final Values)|12.12|STANDARD_ERROR_OF_MEAN|6.69||0.717|TWO_SIDED|95.0|-1.337|25.578|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||25.578|-1.337|0.717
91536373|NCT02501811|182951739|SUPERIORITY||Mean Difference (Final Values)|-1411.7|STANDARD_ERROR_OF_MEAN|840.6||0.11|TWO_SIDED|95.0|-3108.3|284.9|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||284.9|-3108.3|0.110
91536374|NCT02501811|182951739|SUPERIORITY||Mean Difference (Final Values)|-634.6|STANDARD_ERROR_OF_MEAN|405.1||0.112|TWO_SIDED|95.0|-1460.7|191.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||191.4|-1460.7|0.112
91536375|NCT02501811|182951739|SUPERIORITY||Mean Difference (Final Values)|-483.2|STANDARD_ERROR_OF_MEAN|400.7||0.891|TWO_SIDED|95.0|-1301.5|335.2|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||335.2|-1301.5|0.891
91536376|NCT02501811|182951739|SUPERIORITY||Mean Difference (Final Values)|-928.6|STANDARD_ERROR_OF_MEAN|754.2||0.009|TWO_SIDED|95.0|-2470.7|613.6|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||613.6|-2470.7|0.009
91536377|NCT02501811|182951739|SUPERIORITY||Mean Difference (Final Values)|-777.1|STANDARD_ERROR_OF_MEAN|756.5||0.661|TWO_SIDED|95.0|-2323.2|769.1|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||769.1|-2323.2|0.661
91536378|NCT02501811|182951739|SUPERIORITY||Mean Difference (Final Values)|151.5|STANDARD_ERROR_OF_MEAN|162.2||0.015|TWO_SIDED|95.0|-175.4|478.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||478.4|-175.4|0.015
91536379|NCT02501811|182951740|OTHER||slope of time|0.267|STANDARD_ERROR_OF_MEAN|0.241||0.269|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported||||0.269
91536380|NCT02501811|182951741|OTHER||slope of time|0.141|STANDARD_ERROR_OF_MEAN|0.153||0.361|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.361
91536381|NCT02501811|182951742|OTHER||slope of time|-0.267|STANDARD_ERROR_OF_MEAN|0.164||0.107|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.107
91536382|NCT02501811|182951743|OTHER||slope of time|1.395|STANDARD_ERROR_OF_MEAN|0.829||0.095|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.095
91536383|NCT02501811|182951744|OTHER||slope of time|0.603|STANDARD_ERROR_OF_MEAN|0.683||0.379|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.379
91536384|NCT02501811|182951745|OTHER||slope of time|0.003|STANDARD_ERROR_OF_MEAN|0.004||0.401|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.401
91536385|NCT02501811|182951746|OTHER||slope of time|-0.244|STANDARD_ERROR_OF_MEAN|0.158||0.126|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.126
91536386|NCT02501811|182951747|OTHER||slope of time|-0.42|STANDARD_ERROR_OF_MEAN|0.281||0.139|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.139
91536387|NCT02501811|182951748|OTHER||slope of time|-0.133|STANDARD_ERROR_OF_MEAN|0.184||0.472|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.472
91762894|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.2635|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2635
91762895|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762896|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
91762897|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0965
91762898|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91513677|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|1.88||0.238|TWO_SIDED|90.0|-4.45|1.77||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 2||1.77|-4.45|0.238
91513678|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-3.73|STANDARD_ERROR_OF_MEAN|2.11||0.039|TWO_SIDED|90.0|-7.22|-0.24||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 4||-0.24|-7.22|0.039
91513679|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-3.06|STANDARD_ERROR_OF_MEAN|2.34||0.097|TWO_SIDED|90.0|-6.93|0.81||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 8||0.81|-6.93|0.097
91513680|NCT03056690|182899069|SUPERIORITY||LSMean DIfference|-0.99|STANDARD_ERROR_OF_MEAN|0.63||0.057|TWO_SIDED|90.0|-2.03|0.04||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 2||0.04|-2.03|0.057
91513681|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.63||0.018|TWO_SIDED|90.0|-2.39|-0.29||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 4||-0.29|-2.39|0.018
91513682|NCT03056690|182899069|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.7||0.111|TWO_SIDED|90.0|-2.02|0.3||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 8||0.30|-2.02|0.111
91513683|NCT03056690|182899070|SUPERIORITY||LSMean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.36||0.092|TWO_SIDED|90.0|-7.05|0.75||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Function Subscale||0.75|-7.05|0.092
91513684|NCT03056690|182899070|SUPERIORITY||LSMean difference|-3.29|STANDARD_ERROR_OF_MEAN|2.16||0.065|TWO_SIDED|90.0|-6.85|0.28||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Symptoms subscale||0.28|-6.85|0.065
91513685|NCT03056690|182899070|SUPERIORITY||LSMean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.65||0.049|TWO_SIDED|90.0|-2.15|-0.01||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Overall Impact Subscale.||-0.01|-2.15|0.049
91513686|NCT03056690|182899071|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Odds Ratio (OR)|1.43||||0.192|TWO_SIDED|90.0|0.91|2.24|||Likelihood test|||Week 2||2.24|0.91|0.192
91513687|NCT03056690|182899071|SUPERIORITY||Odds Ratio (OR)|1.33||||0.285|TWO_SIDED|90.0|0.86|2.07||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihod test|||Week 4||2.07|0.86|0.285
91513688|NCT03056690|182899071|SUPERIORITY||Odds Ratio (OR)|1.2||||0.486|TWO_SIDED|90.0|0.78|1.87||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihood test|||EOT||1.87|0.78|0.486
91513689|NCT03056690|182899072|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test.|Odds Ratio (OR)|1.32||||0.305|TWO_SIDED|90.0|0.85|2.05|||Likelihood test|||Week 8||2.05|0.85|0.305
91513690|NCT01944046|182899081|SUPERIORITY|||||||0.503||||||not adjusted primary outcome|Mixed Models Analysis|adjusted for baseline, age category, functionality category||||||0.503
91513691|NCT01944046|182899082|SUPERIORITY|||||||0.61||||||not adjusted primary outcome, p threshold 0.05|Mixed Models Analysis|adjustment for value at week 24,||||||0.61
91513692|NCT00153101|182899135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8462||95.0|0.92|1.07|||Regression, Cox|||||1.07|0.92|0.8462
91513693|NCT00153101|182899135|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|1.01||||0.0019||97.5|0.93|1.1|||Regression, Cox|||||1.10|0.93|0.0019
91513694|NCT00153101|182899136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9086||95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.9086
91513695|NCT00153101|182899136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|0.99||||0.0004||97.5|0.9|1.08|||Regression, Cox|||||1.08|0.90|0.0004
91513696|NCT00153101|182899137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.4535||95.0|0.93|1.17|||Regression, Cox|||||1.17|0.93|0.4535
91513697|NCT00153101|182899137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9421||95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9421
91513698|NCT00153101|182899138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2909||95.0|0.94|1.23|||Regression, Cox|||||1.23|0.94|0.2909
91513699|NCT00153101|182899138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2534||95.0|0.94|1.24|||Regression, Cox|||||1.24|0.94|0.2534
91513700|NCT00153101|182899139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2248||95.0|0.79|1.06|||Regression, Cox|||||1.06|0.79|0.2248
91513701|NCT00153101|182899139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.1829||95.0|0.79|1.05|||Regression, Cox|||||1.05|0.79|0.1829
91513702|NCT00153101|182899140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4984||95.0|0.82|1.1|||Regression, Cox|||||1.10|0.82|0.4984
91513703|NCT00153101|182899140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.1203||95.0|0.97|1.29|||Regression, Cox|||||1.29|0.97|0.1203
91513704|NCT00153101|182899141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4221|TWO_SIDED|95.0|0.73|2.15|||Regression, Cox|||||2.15|0.73|0.4221
91513705|NCT00153101|182899141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7305||95.0|0.51|1.6|||Regression, Cox|||||1.60|0.51|0.7305
91513706|NCT00153101|182899142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.6248||95.0|0.54|1.45|||Regression, Cox|||||1.45|0.54|0.6248
91513707|NCT00153101|182899142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0751|TWO_SIDED|95.0|0.36|1.05|||Regression, Cox|||||1.05|0.36|0.0751
91513708|NCT00153101|182899143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3682||95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3682
91513709|NCT00153101|182899143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6014||95.0|0.69|1.24|||Regression, Cox|||||1.24|0.69|0.6014
91513710|NCT00153101|182899144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.255||95.0|0.91|1.42|||Regression, Cox|||||1.42|0.91|0.2550
91513711|NCT00153101|182899144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5297||95.0|0.86|1.34|||Regression, Cox|||||1.34|0.86|0.5297
91513712|NCT00153101|182899145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4593||95.0|0.82|1.56|||Regression, Cox|||||1.56|0.82|0.4593
91513713|NCT00153101|182899145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.7468||95.0|0.68|1.32|||Regression, Cox|||||1.32|0.68|0.7468
91513714|NCT00153101|182899146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.5461|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.5461
91513715|NCT00153101|182899146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.3436||95.0|0.68|1.14|||Regression, Cox|||||1.14|0.68|0.3436
91513716|NCT00153101|182899147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0133||95.0|0.8|0.97|||Regression, Cox|||||0.97|0.80|0.0133
91513717|NCT00153101|182899147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1251||95.0|0.84|1.02|||Regression, Cox|||||1.02|0.84|0.1251
91513718|NCT00153101|182899148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0213||95.0|0.67|0.97|||Regression, Cox|||||0.97|0.67|0.0213
91513719|NCT00153101|182899148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2396||95.0|0.75|1.07|||Regression, Cox|||||1.07|0.75|0.2396
91513720|NCT00153101|182899149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0111||95.0|0.83|0.98|||Regression, Cox|||||0.98|0.83|0.0111
91513721|NCT00153101|182899149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.0606||95.0|0.85|1.0|||Regression, Cox|||||1.00|0.85|0.0606
91513722|NCT00153101|182899150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0082||95.0|1.05|1.35|||Regression, Cox|||||1.35|1.05|0.0082
91513723|NCT00153101|182899150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2164||95.0|0.95|1.23|||Regression, Cox|||||1.23|0.95|0.2164
91513724|NCT00153101|182899151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3732||95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|0.3732
91513725|NCT00153101|182899151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.3633||95.0|0.94|1.2|||Regression, Cox|||||1.20|0.94|0.3633
91513726|NCT00153101|182899152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.2713||95.0|0.97|1.13|||Regression, Cox|||||1.13|0.97|0.2713
91513727|NCT00153101|182899152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.515||95.0|0.95|1.11|||Regression, Cox|||||1.11|0.95|0.5150
91513728|NCT00153101|182899153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.3485||95.0|0.77|1.1|||Regression, Cox|||for subjects without diabetes at baseline||1.10|0.77|0.3485
91513729|NCT00153101|182899153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.1235||95.0|0.96|1.36|||Regression, Cox|||for subjects without diabetes at baseline||1.36|0.96|0.1235
91513730|NCT00153101|182899154|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.869||95.0|0.89|1.11|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.11|0.89|0.8690
91513731|NCT00153101|182899154|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.4337||95.0|0.94|1.17|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.17|0.94|0.4337
91513732|NCT00153101|182899155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.2666||95.0|0.83|1.05|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.05|0.83|0.2666
91513733|NCT00153101|182899155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4784||95.0|0.85|1.08|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.08|0.85|0.4784
91513734|NCT00153101|182899156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0483||95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.0483
91513735|NCT00153101|182899157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2192||95.0|0.81|1.05|||Regression, Cox|||||1.05|0.81|0.2192
91513736|NCT00153101|182899158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7764||95.0|0.85|1.24|||Regression, Cox|||||1.24|0.85|0.7764
91513737|NCT00153101|182899159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0574||95.0|0.62|1.01|||Regression, Cox|||||1.01|0.62|0.0574
91513738|NCT00153101|182899160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1365||95.0|0.64|1.06|||Regression, Cox|||||1.06|0.64|0.1365
91513739|NCT00153101|182899161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.694||95.0|0.82|1.34|||Regression, Cox|||||1.34|0.82|0.6940
91513740|NCT00153101|182899162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.0245||95.0|1.06|2.35|||Regression, Cox|||||2.35|1.06|0.0245
91513741|NCT00153101|182899163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5798||95.0|0.36|1.76|||Regression, Cox|||||1.76|0.36|0.5798
91513742|NCT00153101|182899164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0006||95.0|0.65|0.89|||Regression, Cox|||||0.89|0.65|0.0006
91513743|NCT00153101|182899165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0085||95.0|0.48|0.9|||Regression, Cox|||||0.90|0.48|0.0085
91536388|NCT02501811|182951749|OTHER||slope of time|6.544|STANDARD_ERROR_OF_MEAN|2.882||0.025|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.025
91536389|NCT02501811|182951750|OTHER||slope with interaction|-7.08|STANDARD_ERROR_OF_MEAN|3.3||0.037|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.037
91536390|NCT02501811|182951750|OTHER||slope with interaction|-6.78|STANDARD_ERROR_OF_MEAN|3.18||0.035|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.035
91536391|NCT02501811|182951751|OTHER||slope of time|84.557|STANDARD_ERROR_OF_MEAN|35.81||0.092|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.092
91536392|NCT00151996|182951784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
91536393|NCT00151996|182951784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
91536394|NCT00151996|182951786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||<0.0001
91536395|NCT00151996|182951786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||0.0002
91536396|NCT00151996|182951788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7004||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.7004
91536397|NCT00151996|182951788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
91536398|NCT00151996|182951788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9257||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.9257
91536399|NCT00151996|182951788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
91536400|NCT00420316|182951810|SUPERIORITY_OR_OTHER||Percent reduction|34.3||||0.691|TWO_SIDED|95.0|-348.7|88.9|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||88.9|-348.7|0.691
91536401|NCT00420316|182951811|SUPERIORITY_OR_OTHER||Percent reduction|50.7||||0.551|TWO_SIDED|95.0|-3769.6|99.4|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who have received placebo.||99.4|-3769.6|0.551
91536402|NCT00420316|182951813|SUPERIORITY_OR_OTHER||Percent reduction|100.0||||0.33|TWO_SIDED|95.0|-1822.5|100.0|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||100|-1822.5|0.33
91536403|NCT00420316|182951814|SUPERIORITY_OR_OTHER||Percent reduction|-97.2||||1|TWO_SIDED|95.0|-9610.8|80.5|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||80.5|-9610.8|1
91536404|NCT00420316|182951815|SUPERIORITY_OR_OTHER||Percent reduction|0.0||||1|TWO_SIDED|95.0|0.0|98.7|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||98.7|0|1
91536405|NCT00420316|182951816|SUPERIORITY_OR_OTHER||Percent reduction|-23.2||||0.817|TWO_SIDED|95.0|-287.7|54.8|||Fisher Exact|||Vaccine efficacy with respect to severe gastroenteritis (GE) was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||54.8|-287.7|0.817
91536406|NCT03546907|182951819|SUPERIORITY||Risk Ratio (RR)|0.808||||0.1296|TWO_SIDED|95.0|0.613|1.065|||Negative binomial regression model|||Analysis was performed using negative binomial regression model with total number of events occurring during observation duration as response variable, treatment, baseline eosinophil strata, region, number of severe COPD exacerbations experienced in previous year(0 vs. 1+) at baseline, smoking history(current vs. former smoker), post-BD FEV1 percent(%) predicted (less than\[\<\] 50% vs greater than equal\[\>=\]50%) at baseline as covariates, and log-transformed observation duration as offset variable.||1.065|0.613|0.1296
91536407|NCT04936035|182951838|SUPERIORITY||Difference in LS Mean|-16.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.2|-12.3||MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|||LS Mean Difference between zilebesiran 300 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.||-12.3|-21.2|<0.0001
91536408|NCT04936035|182951838|SUPERIORITY||Difference in LS Mean|-15.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-20.8|-10.6||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|||The adjusted 95% CI and p-value are based on Dunnett's test. LS Mean Difference between zilebesiran 600 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.||-10.6|-20.8|<0.0001
91762899|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
91513744|NCT00153101|182899166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0015||95.0|0.69|0.92|||Regression, Cox|||||0.92|0.69|0.0015
91513745|NCT00153101|182899167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0101||95.0|1.08|1.79|||Regression, Cox|||||1.79|1.08|0.0101
91513746|NCT00153101|182899168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9563||95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.9563
91513747|NCT00153101|182899169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.0868||95.0|0.98|1.41|||Chi-squared|||||1.41|0.98|0.0868
91513748|NCT00153101|182899170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0172||95.0|0.6|0.95|||Regression, Cox|||||0.95|0.60|0.0172
91513749|NCT00153101|182899171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1431||95.0|0.78|1.04|||Regression, Cox|||||1.04|0.78|0.1431
91513750|NCT00153101|182899172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8974||95.0|0.81|1.21|||Regression, Cox|||||1.21|0.81|0.8974
91513751|NCT03169153|182899173|SUPERIORITY||||||<|0.0001|||||||Mixed effects repeated measures|||||||<0.0001
91513752|NCT00439777|182899174|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events will give a power of 90% to demonstrate that rivaroxaban is at least as effective as the comparator, considering a relative non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided alpha=0.05). The mean overall incidence for the primary efficacy outcome of 3% was expected and therefore 1465 patients per group would be needed. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|1.12|STANDARD_ERROR_OF_MEAN|0.2067||0.0026|TWO_SIDED|95.0|0.75|1.68|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.68|0.75|0.0026
91513753|NCT00439777|182899175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|0.86|1.56||Nominal p-value|Regression, Cox||The standard error of the log hazard ratio was estimated.|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.||1.56|0.86|0.33
91513754|NCT00439777|182899176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.1499||0.275|TWO_SIDED|95.0|0.63|1.14||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|||1.14|0.63|0.275
91513755|NCT00439777|182899177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.257||0.55|TWO_SIDED|95.0|0.7|1.93||nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.93|0.70|0.55
91513756|NCT00439777|182899178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|STANDARD_ERROR_OF_MEAN|0.3289||0.85|TWO_SIDED|95.0|0.49|1.79||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.79|0.49|0.85
91513757|NCT00439777|182899179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|STANDARD_ERROR_OF_MEAN|0.08756||0.23|TWO_SIDED|95.0|0.76|1.07||If the primary efficacy analysis shows that rivaroxaban is non-inferior to the comparator, the principal safety outcome was to be compared between treatment groups to maintain the overall type I error of 0.05 (2-sided) (a closed testing procedure).|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.07|0.76|0.23
91513758|NCT01175226|182899216|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.020
91513759|NCT01072201|182899238|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91513760|NCT01072201|182899239|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91513761|NCT01072201|182899240|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups||||0.05
91513762|NCT02752048|182899260|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-1.378||||0.596|TWO_SIDED|95.0|-6.757|4.0|||t-test, 2 sided|||||4.000|-6.757|0.596
91513763|NCT02752048|182899260|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|1.349||||0.433|TWO_SIDED|95.0|-2.22|4.918|||t-test, 2 sided|||||4.918|-2.220|0.433
91513764|NCT02752048|182899261|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.484||||0.382|TWO_SIDED|95.0|-1.618|0.65|||t-test, 2 sided|||||0.650|-1.618|0.382
91513765|NCT02752048|182899261|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.397||||0.501|TWO_SIDED|95.0|-1.61|0.817|||t-test, 2 sided|||||0.817|-1.610|0.501
91513766|NCT02752048|182899262|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.533||||0.549|TWO_SIDED|95.0|-2.363|1.298|||t-test, 2 sided|||||1.298|-2.363|0.549
91513767|NCT02752048|182899262|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.225||||0.767|TWO_SIDED|95.0|-1.801|1.351|||t-test, 2 sided|||||1.351|-1.801|0.767
91513768|NCT02055352|182899331|NON_INFERIORITY_OR_EQUIVALENCE|A change of 5-10% from baseline values is considered to be clinically important. The estimated adjusted treatment difference for budesonide 400 μg twice a day/ indacaterol 150 μg once daily minus fixed combination of fluticasone/ salmeterol 250/ 50 μg twice daily was displayed along with the associated one-sided 97.5% confidence interval. If the lower limit of this confidence interval was to the right (i.e. above) - 10 mL, then non-inferiority could be claimed.||||||0.004|||||||Mixed effects General linear model|||||||0.004
91513769|NCT04745169|182899336|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91513770|NCT04745169|182899337|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91513771|NCT04745169|182899338|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91513772|NCT04745169|182899339|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91513773|NCT04745169|182899340|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91513774|NCT04745169|182899341|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91513775|NCT04745169|182899342|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
91513776|NCT04745169|182899343|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91513777|NCT04745169|182899344|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91513778|NCT01880424|182899360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.001||95.0|1.21|2.09||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||2.09|1.21|0.0010
91513779|NCT01880424|182899361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.0001||95.0|1.83|3.58||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||3.58|1.83|<0.0001
91513780|NCT01303627|182899427|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of \<0.05 was considered statistically significant.|Chi-squared|||The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).||||<0.05
91513781|NCT00795600|182899482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.645|STANDARD_ERROR_OF_MEAN|3.364||0.849||95.0|-7.404|6.114||H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.114|-7.404|0.849
91513782|NCT00795600|182899483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|3.478||0.948||95.0|-7.588|6.407||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.407|-7.588|0.948
91513783|NCT00795600|182899484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.36|STANDARD_ERROR_OF_MEAN|498.7||0.696||95.0|-805.8|1198.5||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1198.5|-805.8|0.696
91513784|NCT00795600|182899485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.81|STANDARD_ERROR_OF_MEAN|515.4||0.71||95.0|-844.0|1229.7||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1229.7|-844.0|0.710
91513785|NCT00795600|182899486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|288.21|STANDARD_ERROR_OF_MEAN|766.41||0.709||95.0|-1252.0|1828.4|||ANCOVA|||||1828.4|-1252.0|0.709
91513786|NCT00795600|182899487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|2.732||0.948||95.0|-5.668|5.313|||ANCOVA|||||5.313|-5.668|0.948
91513787|NCT00795600|182899488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1151.0|STANDARD_ERROR_OF_MEAN|810.48||0.162||95.0|-2780.0|477.33|||ANCOVA|||||477.33|-2780.0|0.162
91513788|NCT00795600|182899489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.747|STANDARD_ERROR_OF_MEAN|1.788||0.131||95.0|-6.34|0.846|||ANCOVA|||||0.846|-6.340|0.131
91513789|NCT00795600|182899490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.4|STANDARD_ERROR_OF_MEAN|368.69||0.766||95.0|-851.3|630.51|||ANCOVA|||||630.51|-851.3|0.766
91513790|NCT00795600|182899491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.662||0.716||95.0|-3.949|2.729|||ANCOVA|||||2.729|-3.949|0.716
91513791|NCT00795600|182899492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.695||0.483||95.0|-0.906|1.888|||ANCOVA|||||1.888|-0.906|0.483
91513792|NCT00795600|182899493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|1.909||0.952||95.0|-3.721|3.953|||ANCOVA|||||3.953|-3.721|0.952
91513793|NCT00795600|182899494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.746||0.711||95.0|-1.778|1.221|||ANCOVA|||||1.221|-1.778|0.711
91513794|NCT00795600|182899495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.585|STANDARD_ERROR_OF_MEAN|1.854||0.397||95.0|-5.31|2.141|||ANCOVA|||||2.141|-5.310|0.397
91513795|NCT00795600|182899496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.916|STANDARD_ERROR_OF_MEAN|10.985||0.421||95.0|-30.99|13.159|||ANCOVA|||||13.159|-30.99|0.421
91513796|NCT00795600|182899497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.061|STANDARD_ERROR_OF_MEAN|6.216||0.42||95.0|-17.55|7.43|||ANCOVA|||||7.430|-17.55|0.420
91536409|NCT04936035|182951839|SUPERIORITY||Difference in LS Mean|-12.0|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-15.7|-8.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-8.3|-15.7|<0.0001
91536410|NCT04936035|182951839|SUPERIORITY||Difference in LS Mean|-9.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-13.4|-4.8||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-4.8|-13.4|<0.0001
91536411|NCT04936035|182951840|SUPERIORITY||Difference in LS Mean|-14.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|-18.9|-9.4||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.4|-18.9|<0.0001
91536412|NCT04936035|182951840|SUPERIORITY||Difference in LS Mean|-14.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-18.9|-9.5||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.5|-18.9|<0.0001
91536413|NCT04936035|182951841|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.0001|TWO_SIDED|95.0|-17.2|-7.1||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-7.1|-17.2|<0.0001
91536414|NCT04936035|182951841|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-15.1|-5.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-5.3|-15.1|<0.0001
91536415|NCT04936035|182951842|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.0001|TWO_SIDED|95.0|3.76|30.64||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||30.64|3.76|<0.0001
91536416|NCT04936035|182951842|SUPERIORITY||Odds Ratio (OR)|17.93|||<|0.0001|TWO_SIDED|95.0|6.24|51.52||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||51.52|6.24|<0.0001
91536417|NCT03745794|182951852|OTHER|||||||0.17|||||||Chi-squared|||||||0.17
91536418|NCT04131933|182951884|SUPERIORITY|It was hypothesized that there would be a 50% reduction in Oncotype DX assay requests following the intervention.||||||0.37|||||||Fisher Exact|Fisher's exact test to compare number of patients with Oncotype DX ordered at 0-6 months (pre-intervention) vs 7-12 months (post-intervention)||Pre-Intervention (Period 1 and Period 2) vs Post-Intervention (Period 3 and Period 4)||||0.37
91536419|NCT00667693|182951888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.55|||Regression, Cox|||||0.55|0.23|<0.001
91536420|NCT01859312|182951918|OTHER|||||||0.021|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.021
91536421|NCT01859312|182951920|OTHER|||||||0.027|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.027
91536422|NCT01859312|182951922|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
91536423|NCT01859312|182951924|OTHER|||||||0.012|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.012
91536424|NCT01859312|182951926|OTHER|||||||0.157|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.157
91536425|NCT01859312|182951928|OTHER|||||||0.015|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.015
91536426|NCT01859312|182951930|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
91536427|NCT01859312|182951932|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
91536428|NCT01859312|182951934|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
91536429|NCT01859312|182951936|OTHER|||||||0.043|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.043
91536430|NCT01859312|182951938|OTHER|||||||0.024|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.024
91536431|NCT01859312|182951940|OTHER|||||||0.031|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.031
91536432|NCT01859312|182951942|OTHER|||||||0.005|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.005
91536433|NCT01859312|182951944|OTHER|||||||0.004|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.004
91513797|NCT00795600|182899498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.961|STANDARD_ERROR_OF_MEAN|13.007||0.705||95.0|-31.1|21.178|||ANCOVA|||||21.178|-31.10|0.705
91513798|NCT00795600|182899499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|STANDARD_ERROR_OF_MEAN|4.776||0.341||95.0|-14.19|5.007|||ANCOVA|||||5.007|-14.19|0.341
91513799|NCT00795600|182899500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.034||0.902||95.0|-0.064|0.073|||ANCOVA|||||0.073|-0.064|0.902
91513800|NCT00795600|182899501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|3.85||0.839||95.0|-8.525|6.947|||ANCOVA|||||6.947|-8.525|0.839
91513801|NCT00795600|182899502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.041||0.607||95.0|-0.105|0.062|||ANCOVA|||||0.062|-0.105|0.607
91513802|NCT00795600|182899503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.777|STANDARD_ERROR_OF_MEAN|3.719||0.635||95.0|-9.254|5.7|||ANCOVA|||||5.700|-9.254|0.635
91513803|NCT00795600|182899504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.628||95.0|-0.663|0.403|||ANCOVA|||||0.403|-0.663|0.628
91513804|NCT00795600|182899505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.92|STANDARD_ERROR_OF_MEAN|17.46||0.535||95.0|-46.03|24.182|||ANCOVA|||||24.182|-46.03|0.535
91513805|NCT00795600|182899506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.918|STANDARD_ERROR_OF_MEAN|4.332||0.66||95.0|-10.65|6.813|||ANCOVA|||||6.813|-10.65|0.660
91513806|NCT00795600|182899533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.629|STANDARD_ERROR_OF_MEAN|0.967||0.518||95.0|-2.572|1.313|||ANCOVA|||||1.313|-2.572|0.518
91513807|NCT00795600|182899534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|1.283||0.673||95.0|-3.123|2.032|||ANCOVA|||||2.032|-3.123|0.673
91513808|NCT00795600|182899535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.386||0.738||95.0|-2.319|3.25|||ANCOVA|||||3.250|-2.319|0.738
91513809|NCT00795600|182899536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.062|STANDARD_ERROR_OF_MEAN|2.168||0.346||95.0|-2.3|6.423|||ANCOVA|||||6.423|-2.300|0.346
91513810|NCT00795600|182899537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|STANDARD_ERROR_OF_MEAN|6.173||0.781||95.0|-10.71|14.167|||ANCOVA|||||14.167|-10.71|0.781
91513811|NCT01659021|182899540|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.18|0.37||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).|Log Rank||Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.|||0.37|0.18|<0.0001
91513812|NCT01659021|182899541|SUPERIORITY||Odds Ratio (OR)|16.85|||<|0.0001|TWO_SIDED|95.0|8.17|34.76||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||34.76|8.17|<0.0001
91513813|NCT01659021|182899542|SUPERIORITY||Odds Ratio (OR)|483.16|||<|0.0001|TWO_SIDED|95.0|94.63|2467.02||P-value was calculated from the CMH Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||2467.02|94.63|<0.0001
91513814|NCT01659021|182899543|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.247|TWO_SIDED|95.0|0.54|1.15||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).|Log Rank|||||1.15|0.54|0.247
91513815|NCT01659021|182899544|OTHER||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.17|0.51|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.|||0.51|0.17|
91513816|NCT01248884|182899548|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
91513817|NCT01248884|182899548|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
91513818|NCT01248884|182899548|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
91513819|NCT01248884|182899548|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
91513820|NCT01248884|182899550|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.26|||||TWO_SIDED|97.5|1.11|1.44||||||||1.44|1.11|
91513821|NCT01248884|182899550|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.33|||||TWO_SIDED|97.5|1.14|1.54||||||||1.54|1.14|
91513822|NCT01248884|182899550|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.25|||||TWO_SIDED|97.5|1.1|1.43||||||||1.43|1.1|
91762900|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.4437|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.4437
91536434|NCT01859312|182951946|OTHER|||||||0.524|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.524
91513823|NCT01248884|182899550|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.58|||||TWO_SIDED|97.5|1.37|1.84||||||||1.84|1.37|
91513824|NCT01248884|182899551|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-3.52|||||TWO_SIDED|97.5|-10.19|3.0||||||||3|-10.19|
91513825|NCT01248884|182899551|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.57|||||TWO_SIDED|97.5|-6.53|7.7||||||||7.7|-6.53|
91513826|NCT01248884|182899552|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.56|||||TWO_SIDED|97.5|-3.27|4.63||||||Immune response non-inferiority - anti-HBs (ELISA)||4.63|-3.27|
91513827|NCT01248884|182899552|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.94|||||TWO_SIDED|97.5|-4.57|2.36||||||Immune response non-inferiority - anti-HBs (ELISA)||2.36|-4.57|
91513828|NCT01248884|182899552|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.4|||||TWO_SIDED|97.5|-4.62|3.8||||||Immune response non-inferiority - anti-HBs (CLIA)||3.8|-4.62|
91513829|NCT01248884|182899552|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.92|||||TWO_SIDED|97.5|-5.07|3.02||||||Immune response non-inferiority - anti-HBs (CLIA)||3.02|-5.07|
91513830|NCT01854827|182899587|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
91513831|NCT01854827|182899588|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
91513832|NCT01854827|182899589|OTHER|Percents with serious AEs prior to liver transplant were calculated, along with one-sided 90% Clopper-Pearson confidence interval lower bounds.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
91513833|NCT01854827|182899590|OTHER|Percent of patients with level 3-5 toxicity are presented along with one-sided 90% Clopper-Pearson confidence interval lower bound.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
91513834|NCT01854827|182899591|OTHER|Percent of patients with other expected AEs are presented along with one-sided 90% Clopper-Pearson confidence limit lower bound.|Percent of patients|27.6|||||ONE_SIDED|90.0|14.5||||||||||14.5|
91513835|NCT01854827|182899592|SUPERIORITY|One-sided testing for superiority of IVIG to historical control.|Odds Ratio (OR)|0.67||||0.5486|ONE_SIDED|90.0||2.38|||Regression, Logistic|||IVIG was compared to the historical placebo control from the START study (n=64): PMID: 24794368 NCT00294684||2.38||0.5486
91762901|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762902|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
91762903|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.1663|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1663
91762904|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762905|NCT00445770|183416308|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
91762906|NCT00445770|183416308|SUPERIORITY_OR_OTHER|||||||0.1049|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1049
91762907|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
91762908|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
91762909|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||0.0442
91762910|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
91762911|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
91762912|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0681|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0681
91762913|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
91762914|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
91536435|NCT01859312|182951948|OTHER|||||||0.007|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.|||0.007
91536436|NCT01859312|182951950|OTHER|||||||0.084|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.084
91536437|NCT01859312|182951952|OTHER|||||||0.057|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.057
91536438|NCT01859312|182951954|OTHER|||||||0.103|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.103
91536439|NCT01859312|182951956|OTHER|||||||0.07|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.070
91536440|NCT02982213|182951959|SUPERIORITY||Mean Difference (Net)|0.025||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.001
91536441|NCT02982213|182951963|EQUIVALENCE|Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.||||||0.001|TWO_SIDED|95.0|||||McNemar|||||||.001
91536442|NCT03247543|182951988|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.05||0.0038|TWO_SIDED|95.0|-10.0|-1.9|||Mixed Models for Repeated Measures|||||-1.9|-10.0|0.0038
91536443|NCT03247543|182951988|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.11||0.0063|TWO_SIDED|95.0|-9.9|-1.7|||Mixed Models for Repeated Measures|||||-1.7|-9.9|0.0063
91536444|NCT03247543|182951989|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0028|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0028
91536445|NCT03247543|182951989|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0099|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0099
91536446|NCT03247543|182951990|SUPERIORITY||Least Square Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.0064|TWO_SIDED|95.0|-6.5|-1.1|||ANCOVA|||||-1.1|-6.5|0.0064
91536447|NCT03247543|182951990|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.46||0.0917|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.0917
91536448|NCT03247543|182951991|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0651|TWO_SIDED|95.0|-0.22|0.01|||ANCOVA|||||0.01|-0.22|0.0651
91536449|NCT03247543|182951991|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.168|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.1680
91536450|NCT03247543|182951992|SUPERIORITY||Risk Difference (RD)|10.1||||0.1316|TWO_SIDED|95.0|-2.9|23.1|||Regression, Logistic|||||23.1|-2.9|0.1316
91536451|NCT03247543|182951992|SUPERIORITY||Risk Difference (RD)|15.4||||0.0276|TWO_SIDED|95.0|2.0|28.9|||Regression, Logistic|||||28.9|2.0|0.0276
91536452|NCT03247543|182951993|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.7||0.2128|TWO_SIDED|95.0|-8.7|1.9|||ANCOVA|||||1.9|-8.7|0.2128
91536453|NCT03247543|182951993|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.83||0.0409|TWO_SIDED|95.0|-11.3|-0.2|||ANCOVA|||||-0.2|-11.3|0.0409
91536454|NCT03247543|182951994|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|-5.4|-1.2|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.2|-5.4|0.0020
91536455|NCT03247543|182951994|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.09||0.0039|TWO_SIDED|95.0|-5.3|-1.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.0|-5.3|0.0039
91536456|NCT03247543|182951994|SUPERIORITY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.05||0.0087|TWO_SIDED|95.0|-4.8|-0.7|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.7|-4.8|0.0087
91536457|NCT03247543|182951994|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0248|TWO_SIDED|95.0|-4.6|-0.3|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.3|-4.6|0.0248
91762915|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0966|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.0966
91762916|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
91762917|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0006
91762918|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.1242|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.1242
91762919|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
91762920|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.001
91536458|NCT03247543|182951995|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.43||0.7003|TWO_SIDED|95.0|-3.3|2.2|||ANCOVA|||||2.2|-3.3|0.7003
91536459|NCT03247543|182951995|SUPERIORITY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45||0.1602|TWO_SIDED|95.0|-4.9|0.8|||ANCOVA|||||0.8|-4.9|0.1602
91536460|NCT03247543|182951996|SUPERIORITY|||||||0.0236|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0236
91536461|NCT03247543|182951996|SUPERIORITY|||||||0.0505|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0505
91536462|NCT03247543|182951996|SUPERIORITY|||||||0.1225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.1225
91536463|NCT03247543|182951996|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.0254
91536464|NCT03247543|182951996|SUPERIORITY|||||||0.0261|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.0261
91536465|NCT03247543|182951996|SUPERIORITY|||||||0.0037|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0037
91536466|NCT03247543|182951996|SUPERIORITY|||||||0.0385|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.0385
91536467|NCT03247543|182951996|SUPERIORITY|||||||0.0956|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0956
91536468|NCT03247543|182951996|SUPERIORITY|||||||0.0962|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0962
91536469|NCT03247543|182951996|SUPERIORITY|||||||0.0744|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0744
91536470|NCT03247543|182951996|SUPERIORITY|||||||0.0218|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.0218
91536471|NCT03247543|182951996|SUPERIORITY|||||||0.115|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.1150
91536472|NCT03247543|182951996|SUPERIORITY|||||||0.1086|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.1086
91536473|NCT03247543|182951996|SUPERIORITY|||||||0.0082|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0082
91536474|NCT03247543|182951996|SUPERIORITY|||||||0.2326|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.2326
91536475|NCT03247543|182951996|SUPERIORITY|||||||0.0883|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0883
91536476|NCT01097343|182951997|SUPERIORITY_OR_OTHER||||||=|0.02|TWO_SIDED|95.0|||||Chi-squared|||A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as \>230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05||||=0.02
91536477|NCT01726023|182952032|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.|Risk Difference (RD)|-0.2|||<|0.001|TWO_SIDED|95.0|-5.53|4.97||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.|% Risk Difference (RD)|RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|units for RD are %|The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.||4.97|-5.53|<0.001
91536478|NCT01726023|182952065|SUPERIORITY_OR_OTHER||Difference in median time (days)|0.5||||0.773|||||||Log Rank|||||||0.773
91536479|NCT01726023|182952066|SUPERIORITY_OR_OTHER||Difference in median time (days)|1.0||||0.598|||||||Log Rank|||||||0.598
91536480|NCT00816829|182952073|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.048
91536481|NCT00816829|182952074|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.203
91536482|NCT00816829|182952075|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.||||0.007
91536483|NCT00816829|182952076|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.199
91536484|NCT00816829|182952077|SUPERIORITY_OR_OTHER|||||||0.114||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.114
91536485|NCT00816829|182952078|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.533
91536486|NCT00816829|182952079|SUPERIORITY_OR_OTHER|||||||0.521||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.521
91536487|NCT00816829|182952080|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.333
91536488|NCT00816829|182952081|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.264
91536489|NCT00816829|182952082|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.401
91536490|NCT04925752|182952169|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||Confidence Interval (CI) for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.182|0.010|<0.0001
91762921|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.1521
91762922|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
91762923|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0070
91536491|NCT04925752|182952169|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.182|0.010|< 0.0001
91536492|NCT04925752|182952170|OTHER|Null Hypothesis 03: LEN - F/TDF\>= 0.8/100PY; Null hypothesis was to be rejected if HIV-1 incidence in LEN is not substantially greater than F/TDF (LEN is comparable to F/TDF).|Rate difference|-0.828|||<|0.0001|TWO_SIDED|95.0|-1.669|-0.255||p-value for rate difference (SC LEN minus F/TDF) is based on a hybrid approach.|Hybrid approach||Exact CI for rate difference versus F/TDF is based on a hybrid approach.|||-0.255|-1.669|<0.0001
91536493|NCT04925752|182952170|SUPERIORITY||Rate Ratio|0.111||||0.00245|TWO_SIDED|95.0|0.024|0.513||P-value for rate ratio versus F/TDF is from a Poisson model.|Poisson model||Confidence interval for rate ratio versus F/TDF is from a Poisson model.|Null Hypothesis 04: LEN vs F/TDF\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than F/TDF.||0.513|0.024|0.00245
91536494|NCT06269367|182952219|SUPERIORITY|||||||0.894|||||||ANOVA|Two way repeated measures ANOVA with time (Baseline, post-intervention) and condition (NewGait, Control) as within-subjects factors||||||0.894
91536495|NCT06269367|182952220|SUPERIORITY||||||>|0.299||||||A priori threshold for statistical significance was set to 0.05|ANOVA|Two way repeated measures ANOVA with time (Baseline, post-intervention) and condition (NewGait, Control) as within-subjects factors||||||>0.299
91536496|NCT06269367|182952221|SUPERIORITY|||||||0.469||||||A priori threshold for statistical significance set to 0.05|ANOVA|Two way repeated measures ANOVA with time (Baseline, post-intervention) and condition (NewGait, Control) as within-subjects factors||||||0.469
91536497|NCT04548622|182952240|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91536498|NCT04548622|182952241|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91536499|NCT04548622|182952242|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91536500|NCT02908620|182952243|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.74||0.322|TWO_SIDED|95.0|-3.06|8.69|||ANOVA||Least squares mean (marginal mean)|||8.69|-3.06|0.322
91536501|NCT02908620|182952244|SUPERIORITY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|5.48||0.134|TWO_SIDED|95.0|-20.38|2.99|||ANOVA||Least squares mean (marginal mean)|||2.99|-20.38|0.134
91762924|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0140
91536502|NCT02908620|182952245|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|4.92||0.442|TWO_SIDED|95.0|-6.48|14.62|||ANOVA||Least squares mean (marginal mean)|||14.62|-6.48|0.442
91536503|NCT02908620|182952246|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|4.78||0.172|TWO_SIDED|95.0|-3.27|16.9|||ANOVA||Least squares mean (marginal mean)|||16.90|-3.27|0.172
91536504|NCT03451851|182952308|SUPERIORITY||Difference in percentage|49.9|||<|0.001|TWO_SIDED|95.0|25.9|69.4|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||69.4|25.9|<0.001
91536505|NCT03451851|182952309|SUPERIORITY||Difference in percentage|55.6|||<|0.001|TWO_SIDED|95.0|32.1|74.0|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||74.0|32.1|<0.001
91536506|NCT03451851|182952310|SUPERIORITY||Difference in percentage|40.1|||=|0.003|TWO_SIDED|95.0|15.6|61.3|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||61.3|15.6|=0.003
91536507|NCT03451851|182952311|SUPERIORITY||Difference in percentage|35.0|||=|0.004|TWO_SIDED|95.0|10.5|56.8|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.8|10.5|=0.004
91536508|NCT03451851|182952312|SUPERIORITY||Difference in percentage|34.1|||=|0.002|TWO_SIDED|25.0|9.7|56.1|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.1|9.7|=0.002
91536509|NCT03451851|182952313|SUPERIORITY||LS Mean difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.33|-3.06|||Mixed model repeated measures (MMRM)|||Guselkumab Vs Placebo||-3.06|-7.33|<0.001
91536510|NCT03451851|182952319|SUPERIORITY||Difference in percentage|59.8|||<|0.001|TWO_SIDED|95.0|36.9|77.6||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||77.6|36.9|<0.001
91536511|NCT03451851|182952327|SUPERIORITY||Difference in percentage|46.7|||=|0.002|TWO_SIDED|95.0|21.9|67.3||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||||67.3|21.9|=0.002
91536512|NCT03451851|182952329|SUPERIORITY||Difference in Percentage|23.1|||=|0.139|TWO_SIDED|95.0|-3.4|47.0||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||47.0|-3.4|=0.139
91536513|NCT03451851|182952331|SUPERIORITY||Difference in LS Mean|-5.44|||<|0.001|TWO_SIDED|95.0|-8.0|-2.87||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-2.87|-8.00|<0.001
91536514|NCT03451851|182952333|SUPERIORITY||LS Mean difference|-14.78|||<|0.001|TWO_SIDED|95.0|-20.28|-9.28||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-9.28|-20.28|<0.001
91536515|NCT02380742|182952354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.02
91536516|NCT02380742|182952355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|0.87||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.||||.03
91762925|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
91536517|NCT02380742|182952356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.811|STANDARD_ERROR_OF_MEAN|0.83||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.||||.03
91536518|NCT02380742|182952357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.63||0.09|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.09
91536519|NCT01227278|182952362|SUPERIORITY_OR_OTHER||Rate ratio|1.03||||0.941|TWO_SIDED|95.0|0.67|1.58|||Van Elteren Test|Day 1 to 393: Van Elteren test was used to compare the two arms.|95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.|||1.58|0.67|0.941
91536520|NCT03110458|182952402|SUPERIORITY|||||||0.8466|||||||ANCOVA|||||||0.8466
91536521|NCT03110458|182952403|SUPERIORITY|||||||0.9538|||||||ANCOVA|||||||0.9538
91536522|NCT03110458|182952404|SUPERIORITY|||||||0.3166|||||||ANCOVA|||||||0.3166
91536523|NCT03110458|182952405|SUPERIORITY|||||||0.393|||||||ANCOVA|||||||0.393
91536524|NCT03110458|182952408|SUPERIORITY|||||||0.5324|||||||ANCOVA|||||||0.5324
91536525|NCT00097253|182952431|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Regression, Linear|||Cortisol. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.83
91536526|NCT00097253|182952431|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Mixed Models Analysis|||Epinephrine. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.16
91536527|NCT00097253|182952431|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||Mixed Models Analysis|||Norepinephrine. Model controlled for Time 1 baseline. Comparing timepoints 4 and 5 for pre versus post stressor, e.g. lemon versus water control; Citrus(5-4)-Water(5-4).||||0.017
91536528|NCT00097253|182952432|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Models Analysis|||IL-6. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.10
91536529|NCT00097253|182952432|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Mixed Models Analysis|||IL-10. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.50
91536530|NCT00097253|182952433|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Mixed Models Analysis|||Repeated-measures mixed effects models were used. Model was fit to the log-transformed data. Analysis applied to odor category, e.g. lavender / lemon / water.||||0.60
91536531|NCT00097253|182952434|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Linear|||The maximum DTH wheal of days 1-3 (24, 48, or 72 h) was used as the dependent variable for each subject at each visit. Visits for subjects with a maximum DTH wheal of 5mm or less were excluded. A repeated measures linear model was used to evaluate odor and placebo effects.||||0.014
91536532|NCT04511650|182952455|SUPERIORITY|||||||0.4795|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by disease severity.||Pooled Razuprotafib comparison to Placebo. All results are summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95% confidence intervals (CIs) of the difference between response rates, and p-values.||||0.4795
91536533|NCT00835380|182952480|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.0||||||95.0|89.0|99.0||||||||99|89|
91536534|NCT03727854|182952482|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
91536535|NCT03727854|182952483|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||0.971
91536536|NCT03727854|182952484|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|||||||0.608
91536537|NCT03727854|182952485|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
91536538|NCT03727854|182952486|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||||||0.823
91536539|NCT03727854|182952487|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
91536540|NCT03727854|182952488|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
91536541|NCT03727854|182952489|SUPERIORITY|||||||0.652|||||||t-test, 2 sided|||||||0.652
91536542|NCT03727854|182952490|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
91536543|NCT01081145|182952491|SUPERIORITY_OR_OTHER_LEGACY||Difference in treatment failures|-15.6||||0.006|TWO_SIDED|95.0|-26.6|-4.5|||Cochran-Mantel-Haenszel|||||-4.5|-26.6|0.006
91536544|NCT01081145|182952492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Log Rank|||||||0.003
91536545|NCT01081145|182952493|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-6.24|||<|0.001|TWO_SIDED|95.0|-9.01|-3.48||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-3.48|-9.01|<0.001
91536546|NCT01081145|182952494|SUPERIORITY_OR_OTHER_LEGACY||Difference in percent of subjects|17.5||||0.001|TWO_SIDED|95.0|6.6|28.5||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||28.5|6.6|0.001
91536547|NCT01081145|182952495|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.06||||0.118|TWO_SIDED|95.0|-0.14|0.02||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.02|-0.14|0.118
91536548|NCT01081145|182952498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
91536549|NCT01081145|182952502|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
91536550|NCT03593070|182952505|OTHER|Analyses compared changes in total scores for the MM-CGI from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.646|STANDARD_DEVIATION|0.622||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
91536551|NCT03593070|182952506|OTHER||Slope|0.444|STANDARD_DEVIATION|0.105||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||Analyses compared changes in total scores for the CESD from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).||||0.001
91536552|NCT03593070|182952507|OTHER|Analyses compared changes in total State Trait Anxiety Inventory (STAI) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.514|STANDARD_DEVIATION|0.102||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
91536553|NCT03593070|182952508|OTHER|Analyses compared changes in total positive state of mind scale (PSOMS) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.653|STANDARD_DEVIATION|0.093||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
91536554|NCT03593070|182952509|OTHER|Analyses compared changes in conflict scores (based on FPCR) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.609|STANDARD_DEVIATION|0.07||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
91536555|NCT03593070|182952510|OTHER|Analyses compared changes in total scores for satisfaction with care measure (FPCT) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.731|STANDARD_DEVIATION|0.074||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
91536556|NCT03593070|182952511|OTHER|Analyses compared changes in total Family Knowledge of Alzheimer's Test (FKAT) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.687|STANDARD_DEVIATION|0.084||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
91536557|NCT03593070|182952512|OTHER||Slope|0.527|STANDARD_DEVIATION|0.088||0.001|TWO_SIDED|||||A prior alpha=0.05.|Regression, Linear|||Analyses compared changes in caregiver sense of loss, guilt, and role captivity scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT). This measure uses 51 items of the FPCR measure.||||0.001
91536558|NCT04538664|182952521|SUPERIORITY||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.296|0.528|||Log Rank|||||0.528|0.296|<0.0001
91536559|NCT03536884|182952624|NON_INFERIORITY|The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.|Risk Difference (RD)|12.682|||||TWO_SIDED|95.0|5.771|19.592||||||Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).||19.592|5.771|
91536560|NCT03536884|182952624|SUPERIORITY||Odds Ratio (OR)|1.714|||<|0.001|TWO_SIDED|95.0|1.271|2.31||P-values for the comparison of treatment groups are based on the CMH test for the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||2.310|1.271|<0.001
91536561|NCT03536884|182952625|SUPERIORITY||Odds Ratio (OR)|2.817|||<|0.001|TWO_SIDED|95.0|2.068|3.836||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.836|2.068|<0.001
91536562|NCT03536884|182952627|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.001|TWO_SIDED|95.0|1.835|3.377||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.377|1.835|<0.001
91536563|NCT03536884|182952627|SUPERIORITY||Odds Ratio (OR)|2.168|||<|0.001|TWO_SIDED|95.0|1.511|3.11||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.110|1.511|<0.001
91536564|NCT03536884|182952627|SUPERIORITY||Odds Ratio (OR)|3.243|||<|0.001|TWO_SIDED|95.0|2.103|5.0||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.000|2.103|<0.001
91536565|NCT03722446|182952632|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91536566|NCT03722446|182952633|SUPERIORITY|||||||0.0102|||||||t-test, 1 sided|||||||0.01020
91536567|NCT03722446|182952634|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
91536568|NCT03722446|182952635|SUPERIORITY|||||||0.3753|||||||Chi-squared|||||||0.3753
91536569|NCT03722446|182952636|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
91536570|NCT03722446|182952637|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91536571|NCT00635817|182952644|SUPERIORITY_OR_OTHER|||||||0.099||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.099
91536572|NCT00635817|182952644|SUPERIORITY_OR_OTHER|||||||0.074||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.074
91536573|NCT00635817|182952644|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.026
91536574|NCT00635817|182952644|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.102
91536575|NCT00635817|182952645|SUPERIORITY_OR_OTHER|||||||0.008||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.008
91536576|NCT00635817|182952645|SUPERIORITY_OR_OTHER|||||||0.002||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.002
91536577|NCT00635817|182952645|SUPERIORITY_OR_OTHER|||||||0.347||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.347
91762926|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
91536578|NCT00635817|182952645|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.150
91536579|NCT04341298|182952648|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
91536580|NCT04341298|182952649|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
91536581|NCT04341298|182952650|SUPERIORITY|||||||0.66|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.||||0.66
91536582|NCT04341298|182952651|SUPERIORITY|||||||0.59|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.||||0.59
91536583|NCT04341298|182952652|SUPERIORITY|||||||0.19|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.||||0.19
91536584|NCT04341298|182952653|SUPERIORITY|||||||1|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.||||1.0
91536585|NCT04341298|182952654|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Pain score difference after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.021
91536586|NCT04341298|182952655|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Pain score difference after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.019
91536587|NCT04341298|182952656|SUPERIORITY|Null hypothesis is that proportion of headaches with light sensitivity experienced after 2 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||||0.028|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||||||0.028
91536588|NCT04341298|182952657|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.46
91536589|NCT04487080|182952658|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.85|||Log Rank||HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.|||0.85|0.58|0.0002
91536590|NCT03944512|182952689|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.37|1.19||||||||1.19|0.37|
91536591|NCT03944512|182952690|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.07|2.67||||||||2.67|0.07|
91536592|NCT03944512|182952691|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.32|77.16||||||||77.16|0.32|
91536593|NCT03944512|182952692|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.22|1.43||||||||1.43|0.22|
91536594|NCT03944512|182952693|SUPERIORITY||||||||||||||||||RR not reported given zero events in the placebo group.|||
91536595|NCT03944512|182952694|SUPERIORITY||Risk Ratio (RR)|1.75|||||TWO_SIDED|95.0|0.58|5.24||||||||5.24|0.58|
91536596|NCT03944512|182952695|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
91536597|NCT03944512|182952696|SUPERIORITY||||||||||||||||||RR not reported given zero events in the pravastatin and placebo groups|||
91536598|NCT03944512|182952697|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91536599|NCT03944512|182952698|SUPERIORITY||||||||||||||||||RR not reported given zero events in the placebo group|||
91536600|NCT03944512|182952699|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91536601|NCT03944512|182952700|SUPERIORITY||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|0.73|2.23||||||||2.23|0.73|
91536602|NCT03944512|182952701|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.57|2.91||||||||2.91|0.57|
91536603|NCT03944512|182952702|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.19|1.71||||||||1.71|0.19|
91536604|NCT03944512|182952703|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.02|5.35||||||||5.35|0.02|
91536605|NCT03944512|182952704|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||||||0.72
91536606|NCT03944512|182952705|SUPERIORITY||Risk Ratio (RR)|1.38|||||TWO_SIDED|95.0|0.24|13.59||||||||13.59|0.24|
91536607|NCT03944512|182952706|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.42|2.73||||||||2.73|0.42|
91536608|NCT03944512|182952707|SUPERIORITY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.58|2.18||||||||2.18|0.58|
91536609|NCT03944512|182952708|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91536610|NCT03944512|182952709|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.52|4.51||||||||4.51|0.52|
91536611|NCT03944512|182952710|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.42|5.0||||||||5.00|0.42|
91536612|NCT03944512|182952711|SUPERIORITY||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.11|2.95||||||||2.95|0.11|
91536613|NCT03944512|182952712|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536614|NCT03944512|182952713|SUPERIORITY||||||||||||||||||RR not reported given zero events in the pravastatin group.|||
91536615|NCT03944512|182952714|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536616|NCT03944512|182952715|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536617|NCT03944512|182952716|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536618|NCT03944512|182952717|SUPERIORITY||||||||||||||||||RR not reported given zero events in pravastatin group.|||
91536619|NCT03944512|182952718|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536620|NCT03944512|182952719|SUPERIORITY||Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.17|2.04||||||||2.04|0.17|
91536621|NCT03944512|182952720|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536622|NCT03944512|182952721|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.03|31.79||||||||31.79|0.03|
91536623|NCT03944512|182952722|SUPERIORITY||||||||||||||||||RR not reported given zero events in both groups.|||
91536624|NCT03944512|182952723|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91536625|NCT03944512|182952724|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
91536626|NCT03944512|182952725|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91536627|NCT03944512|182952726|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
91536628|NCT03944512|182952727|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91536629|NCT03944512|182952728|SUPERIORITY|||||||0.22|||||||Fisher Exact||||RR not reported given zero events in the pravastatin group.|||0.22
91536630|NCT03944512|182952729|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
91536631|NCT03944512|182952730|SUPERIORITY|||||||0.47|||||||Fisher Exact||||RR not reported given zero events in the pravastatin group.|||0.47
91536632|NCT01090024|182952746|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.083|STANDARD_ERROR_OF_MEAN|0.624||0.4473|TWO_SIDED|95.0|-1.147|1.313|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.313|-1.147|0.4473
91536633|NCT01090024|182952746|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.67|STANDARD_ERROR_OF_MEAN|0.625||0.1426|TWO_SIDED|95.0|-0.563|1.903|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.903|-0.563|0.1426
91536634|NCT01090024|182952746|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.281|STANDARD_ERROR_OF_MEAN|0.611||0.3231|TWO_SIDED|95.0|-0.924|1.486|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.486|-0.924|0.3231
91536635|NCT01090024|182952747|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.056|STANDARD_ERROR_OF_MEAN|0.063||0.1879|TWO_SIDED|95.0|-0.18|0.068|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.068|-0.180|0.1879
91536636|NCT01090024|182952747|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.026|STANDARD_ERROR_OF_MEAN|0.063||0.3384|TWO_SIDED|95.0|-0.151|0.098|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.098|-0.151|0.3384
91536637|NCT01090024|182952747|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.093|STANDARD_ERROR_OF_MEAN|0.062||0.067|TWO_SIDED|95.0|-0.214|0.029|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.029|-0.214|0.0670
91536638|NCT00470626|182952780|SUPERIORITY_OR_OTHER||Probability of Successful Retrieval|0.9||||||95.0|||||||Probability of successful retrieval is from Kaplan-Meier analysis.|||||
91536639|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.235|TWO_SIDED|95.0|0.45|1.22|||Univariate logistic regression model|||Comparison between genders: women and men.||1.22|0.45|0.235
91536640|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.331|TWO_SIDED|95.0|0.55|1.22|||Univariate logistic regression model|||Comparison between Age: \<= 55 years and \> 55 years||1.22|0.55|0.331
91536641|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.05|TWO_SIDED|95.0|1.0|2.23|||Univariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.23|1.00|0.050
91536642|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.144|TWO_SIDED|95.0|0.88|2.46|||Univariate logistic regression model|||Comparison between participants without erosive rheumatoid arthritis (RA) and participants with erosive RA||2.46|0.88|0.144
91536643|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.65|||Univariate logistic regression model|||Comparison between DAS-28 score: \<= 5.1 and DAS-28 \>5.1||2.65|1.14|0.010
91536644|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.119|TWO_SIDED|95.0|0.92|2.1|||Univariate logistic regression model|||Comparison between ESR: \<= 28 mm/h and \> 28 mm/h||2.10|0.92|0.119
91536645|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.265|TWO_SIDED|95.0|0.81|2.13|||Univariate logistic regression model|||Comparison between number of participants without anemia and number of participants with anemia||2.13|0.81|0.265
91536646|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.511|TWO_SIDED|95.0|0.77|1.71|||Univariate logistic regression model|||Comparison between dose of corticosteroids: \<= 5 mg and \> 5 mg||1.71|0.77|0.511
91536647|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.153|TWO_SIDED|95.0|0.9|2.0|||Univariate logistic regression model|||Comparison between HAQ score: \<= 1.5 and \> 1.5||2.00|0.90|0.153
91536648|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.001|TWO_SIDED|95.0|1.45|3.31|||Univariate logistic regression model|||Comparison between VAS patient: fatigue \<= 66 and \> 66||3.31|1.45|<0.001
91513836|NCT01854827|182899593|SUPERIORITY|One-sided testing for superiority of IVIG relative to historical control.|Odds Ratio (OR)|0.33||||0.8455|ONE_SIDED|90.0||1.22|||Regression, Logistic|||IVIG was compared for superiority to the historical control of START study placebo (N=64). PMID: 24794368 NCT00294684||1.22||0.8455
91513837|NCT01854827|182899594|SUPERIORITY|One-sided.|Odds Ratio (OR)|0.29||||0.8431|ONE_SIDED|90.0||1.24||One-sided|Regression, Logistic|||IVIG was compared for superiority to the historical START placebo control (N=64).||1.24||0.8431
91513838|NCT01854827|182899595|SUPERIORITY|One-sided for IVIG superior to historical START placebo control. PMID: 24794368 NCT00294684|Risk Difference (RD)|-11.9|||||ONE_SIDED|90.0||2.1||||||K-M estimates for survival for IVIG vs the historical START placebo control are provided, along with one-sided 90% upper bounds of the confidence intervals.||2.1||
91513839|NCT00736996|182899597|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with PIO was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
91513840|NCT00736996|182899597|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with EET was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
91513841|NCT00736996|182899598|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
91513842|NCT00736996|182899598|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
91513843|NCT00736996|182899599|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
91513844|NCT00736996|182899599|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
91513845|NCT02660944|182899635|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|0.37||||0.845|TWO_SIDED|95.0|-3.42|4.15|||t-test, 2 sided|||Change from baseline at Day 85 RSLV-132 versus placebo||4.15|-3.42|0.845
91513846|NCT02660944|182899635|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-0.48||||0.818|TWO_SIDED|95.0|-4.66|3.7|||t-test, 2 sided|||Change from baseline at Day 169 RSLV-132 versus placebo||3.70|-4.66|0.818
91513847|NCT03586999|182899648|SUPERIORITY||proportion|0.3||||0.1|TWO_SIDED|90.0||||The proportion achieving a complete response will be calculated and will compared to null proportion of 30%. The population proportion for complete response rate, p-value and 90% confidence intervals for the complete response rate will be calculated.|t-test, 2 sided|||The study was to be suspended, if, at any time, there was sufficient evidence to suggest that the true probability of achieving a complete response falls below 30% while assuming the treatment drug will elicit a 56% complete response rate. Statistically significant evidence for this low complete response rate is defined as an observed complete response rate whose upper one-sided 90% confidence limit is 0-30%. Sample size calculations were made assuming 80% power.||||.1
91513848|NCT04096560|182899658|SUPERIORITY||LS Mean Difference|26.4|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|20.07|32.73||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||32.73|20.07|<0.001
91513849|NCT04096560|182899658|SUPERIORITY||LS Mean Difference|29.9|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|23.68|36.07||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||36.07|23.68|<0.001
91536649|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.001|TWO_SIDED|95.0|1.35|3.08|||Univariate logistic regression model|||Comparison between VAS patient: pain \<= 66 and \> 66||3.08|1.35|<0.001
91536650|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.261|TWO_SIDED|95.0|0.86|2.75|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<=30 score and 30 - 59 score||2.75|0.86|0.261
91536651|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.261|TWO_SIDED|95.0|0.67|2.05|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and 59 - 77||2.05|0.67|0.261
91536652|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.261|TWO_SIDED|95.0|0.95|2.89|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and \> 77||2.89|0.95|0.261
91536653|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.001|TWO_SIDED|95.0|1.38|3.14|||Univariate logistic regression model|||Comparison between VAS patient: global assessment score: \<= 67 and \> 67||3.14|1.38|<0.001
91536654|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.5|3.47|||Univariate logistic regression model|||Comparison between SF36 vitality score: \> 33 and \<= 33||3.47|1.50|< 0.001
91536655|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.399|TWO_SIDED|95.0|0.6|1.93|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Doubtful case)||1.93|0.60|0.399
91536656|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.399|TWO_SIDED|95.0|0.48|1.26|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Certain case)||1.26|0.48|0.399
91536657|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.858|TWO_SIDED|95.0|0.65|1.81|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Doubtful case)||1.81|0.65|0.858
91536658|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.858|TWO_SIDED|95.0|0.57|1.52|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Certain case)||1.52|0.57|0.858
91536659|NCT01185522|182952803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.036|TWO_SIDED|95.0|1.03|2.58|||Multivariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.58|1.03|0.036
91536660|NCT01185522|182952804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Univariate logistic regression model|||Predictive factor: C-Reactive Protein||1.28|1.05|0.004
91536661|NCT01185522|182952804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.013|TWO_SIDED|95.0|1.03|1.27|||Multivariate logistic regression model|||Predictive factor: C-Reactive Protein||1.27|1.03|0.013
91536662|NCT01185522|182952805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.253|TWO_SIDED|95.0|0.99|1.05|||Univariate logistic regression model|||Predictive factor: Tender joint||1.05|0.99|0.253
91536663|NCT01185522|182952805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.021|TWO_SIDED|95.0|1.01|1.09|||Univariate logistic regression model|||Predictive factor : Swollen joint||1.09|1.01|0.021
91536664|NCT01729819|182952817|SUPERIORITY|The change in mean nocturnal voids from baseline as the dependent variable, baseline mean nocturnal voids as a covariate, and treatments and visit (Month 1, Month 2, and Month 3) as factors, was considered for the analysis. Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. Missing values post-baseline were not imputed.|Mean Difference (Final Values)|-0.34||||0.112|TWO_SIDED|95.0|-0.77|0.08|||ANCOVA|Change in mean nocturnal voids as the dependent variable and baseline mean nocturnal voids as a covariate, treatment and visit as factors.|Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented. The trial was to be declared positive if a statistically significant (two-sided, p \< 0.05) positive effect for combining tolterodine and desmopressin compared to tolterodine monotherapy on the primary endpoint had been demonstrated.||0.08|-0.77|0.112
91536665|NCT01729819|182952818|SUPERIORITY||Mean Difference (Final Values)|18.0||||0.385|TWO_SIDED|95.0|-22.96|58.96|||ANCOVA|Change in mean time to first void as dependent variable and baseline mean time to first void as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented.||58.96|-22.96|0.385
91536666|NCT01729819|182952819|SUPERIORITY||Mean Difference (Final Values)|-64.16||||0.103|TWO_SIDED|95.0|-141.46|13.14|||ANCOVA|Change in mean nocturnal volume as the dependent variable and baseline mean nocturnal volume as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented||13.14|-141.46|0.103
91536667|NCT01729819|182952820|SUPERIORITY||Odds Ratio (OR)|1.36||||0.352|TWO_SIDED|95.0|0.71|2.62||33% responder status as dependent variable, baseline mean nocturnal voids as covariate, treatment, and visit as factors.|Generalized Estimating Equation|||Combination versus tolterodine (i.e. odds of being responder in combination group versus odds of being responder in tolterodine group) is presented. The proportion of responders during three months of treatment was analysed (i.e. the odds ratio of the odds of being a responder) longitudinally using Generalised Estimating Equation (GEE) for a repeated logistic regression.||2.62|0.71|0.352
91536668|NCT01729819|182952821|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.443||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 1|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 1||||0.443
91536669|NCT01729819|182952821|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.086||||||Adjusted treatment difference in mean number of nocturnal voids (Combination-tolterodine) at Month 2|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 2||||0.086
91536670|NCT01729819|182952821|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.055||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 3|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 3||||0.055
91536671|NCT01729819|182952821|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.106||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids for the duration of 3 months|ANCOVA|||Treatment difference (Combination-tolterodine) for the duration of 3 months||||0.106
91536672|NCT01729819|182952822|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.178|TWO_SIDED|95.0|-0.2|1.05|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented.Statistical analysis for from very tired to wide awake, how do you feel now"||1.05|-0.20|0.178
91536673|NCT01729819|182952822|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.257|TWO_SIDED|95.0|-0.26|0.94|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate how refreshed you feel now"||0.94|-0.26|0.257
91536674|NCT01729819|182952822|SUPERIORITY|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Mean Difference (Final Values)|0.28||||0.36|TWO_SIDED|95.0|-0.32|0.88|||ANCOVA|Longitudinal analysis of covariance on change from baseline with baseline as a covariate, and treatment and visit as factors.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate the quality of your sleep last night"||0.88|-0.32|0.360
91536675|NCT02987543|182952832|SUPERIORITY||Odds Ratio (OR)|20.86|||<|0.0001|TWO_SIDED|95.0|4.18|379.18|||Regression, Logistic|||||379.18|4.18|<0.0001
91536676|NCT02987543|182952833|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.38|0.63|||Regression, Cox|||||0.63|0.38|<0.0001
91536677|NCT02987543|182952834|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0192|TWO_SIDED|95.0|0.22|0.91|||Regression, Cox|||||0.91|0.22|0.0192
91536678|NCT02987543|182952835|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0175|TWO_SIDED|95.0|0.5|0.97||2-sided p-value|Regression, Cox|||||0.97|0.50|0.0175
91536679|NCT02987543|182952836|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|||||0.47|0.25|<0.0001
91536680|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.44|0.69||||||"Abdomen 10 minutes~Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.69|-0.44|
91536681|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.36|2.49||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.49|1.36|
91536682|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.73|0.36||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.36|-0.73|
91536683|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.23|||||TWO_SIDED|95.0|1.69|2.78||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.78|1.69|
91536684|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.9|0.31||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.31|-0.90|
91536685|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|1.98|3.22||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.22|1.98|
91536686|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.61|0.57||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.57|-0.61|
91536687|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|1.72|2.93||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.93|1.72|
91762927|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0815|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0815
91762928|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
91536688|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.91|0.22||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.22|-0.91|
91536689|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.45|||||TWO_SIDED|95.0|1.88|3.01||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.01|1.88|
91536690|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.85|0.24||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.24|-0.85|
91536691|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.41|||||TWO_SIDED|95.0|1.87|2.95||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.95|1.87|
91536692|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.67|0.4||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.40|-0.67|
91536693|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|1.7|2.8||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.80|1.70|
91536694|NCT03224299|182952837|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.56|0.48||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.48|-0.56|
91536695|NCT03224299|182952837|SUPERIORITY||Mean Difference (Final Values)|2.15|||||TWO_SIDED|95.0|1.62|2.68||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.68|1.62|
91536696|NCT00309452|182952849|SUPERIORITY_OR_OTHER|||||||0.018|||||||Chi-squared, Corrected|||Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization||||0.018
91536697|NCT00309452|182952853|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement||||0.002
91536698|NCT02962674|182952862|SUPERIORITY|||||||0.004|||||||t-test, 1 sided|||"The null and alternative hypotheses associated with this objective was written as:~H0: μ ΔIPSS ≤ 6.5 points HA: μ ΔIPSS \> 6.5 points where μ ΔIPSS was the true underlying value of mean ΔIPSS following a treatment at the 3-month follow-up visit and 6.5 points was an objective performance goal (OPG). The objective was met at a given time point by rejecting the null hypothesis in a one-sided t-test at the 5% significance level."||||0.004
91536699|NCT00771667|182952876|SUPERIORITY_OR_OTHER|||||||0.005||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.005
91536700|NCT00771667|182952876|SUPERIORITY_OR_OTHER|||||||0.057||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.057
91536701|NCT00771667|182952876|SUPERIORITY_OR_OTHER|||||||0.021||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.021
91536702|NCT00771667|182952877|SUPERIORITY_OR_OTHER|||||||0.682|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.682
91536703|NCT00771667|182952877|SUPERIORITY_OR_OTHER|||||||0.206|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.206
91536704|NCT00771667|182952877|SUPERIORITY_OR_OTHER|||||||0.196|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.196
91536705|NCT00771667|182952878|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.008
91536706|NCT00771667|182952878|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
91536707|NCT00771667|182952878|SUPERIORITY_OR_OTHER|||||||0.035|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.035
91536708|NCT00771667|182952879|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
91536709|NCT00771667|182952879|SUPERIORITY_OR_OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.007
91536710|NCT00771667|182952879|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.006
91536711|NCT00771667|182952880|SUPERIORITY_OR_OTHER|||||||0.074|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.074
91536712|NCT00771667|182952880|SUPERIORITY_OR_OTHER|||||||0.081|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.081
91536713|NCT00771667|182952880|SUPERIORITY_OR_OTHER|||||||0.105|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.105
91536714|NCT00771667|182952881|SUPERIORITY_OR_OTHER|||||||0.029||||||Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.|Cochran-Mantel-Haenszel|The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.||||||0.029
91536715|NCT00771667|182952882|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for induction dose and clinical remission status at Week 6.||||||<0.001
91762929|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0002
91762930|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0886|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0886
91513850|NCT04096560|182899658|SUPERIORITY||LS Mean Difference|35.0|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|28.73|41.34||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||41.34|28.73|<0.001
91513851|NCT04096560|182899665|SUPERIORITY||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-14.07|-6.16||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-6.16|-14.07|<0.001
91513852|NCT04096560|182899665|SUPERIORITY||LS Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-15.2|-7.56||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-7.56|-15.20|<0.001
91536716|NCT02814643|182952928|OTHER||Geometric least-square mean ratio|0.87|||||TWO_SIDED|90.0|0.56|1.35|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.35|0.56|
91536717|NCT02814643|182952928|OTHER||Geometric least-square mean ratio|1.19|||||TWO_SIDED|90.0|0.82|1.71|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.71|0.82|
91536718|NCT02814643|182952928|OTHER||Geometric least-square mean ratio|0.93|||||TWO_SIDED|90.0|0.67|1.29|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.29|0.67|
91536719|NCT02814643|182952928|OTHER||Geometric least-square mean ratio|0.8|||||TWO_SIDED|90.0|0.54|1.19|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.19|0.54|
91536720|NCT02814643|182952929|OTHER||Geometric least-square mean ratio|1.0|||||TWO_SIDED|90.0|0.76|1.31|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.31|0.76|
91536721|NCT02814643|182952929|OTHER||Geometric least-square mean ratio|1.28|||||TWO_SIDED|90.0|0.93|1.77|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.77|0.93|
91536722|NCT02814643|182952929|OTHER||Geometric least-square mean ratio|1.03||||||90.0|0.79|1.34|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.34|0.79|
91536723|NCT02814643|182952929|OTHER||Geometric least-square mean ratio|1.26||||||90.0|0.93|1.7|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.70|0.93|
91536724|NCT00558363|182952960|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.5||Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy|||0.50|0.23|<0.001
91536725|NCT00558363|182952970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 57% versus 28%|Mantel-Haenszel Chi-Square|||||||<0.001
91536726|NCT00558363|182952971|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.25|||<|0.001||95.0|0.14|0.45||Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy|||0.45|0.14|<0.001
91536727|NCT00558363|182952972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 35% versus 10%|Mantel-Haenszel Chi-Square|||||||<0.001
91536728|NCT02174562|182952992|SUPERIORITY||Risk Ratio (RR)|1.21||||0.31|TWO_SIDED|95.0|0.84|1.75||0.05 was the a priori level of significance.|Poisson regression with robust SEs||PC-OT is the numerator, Enhanced Usual care is the denominator|Null hypothesis is that the Relative Risk of reduction of HbA1C \>=0.5 for PCOT vs EUC is 1.||1.75|0.84|0.31
91762931|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
91762932|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0003
91762933|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.1488|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1488
91536729|NCT02174562|182952993|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|P-value is for comparison of least squares means for period 2 (months 4-6).||Mixed effects linear regression was used to model the percentage of doses taken each month. Fixed effects were period (1-3 months, 4-6 months, 7-9 months, 10-12 months), randomization group, randomization by period interaction, stratification group, age, and run-in percentage doses taken. The outcome was transformed using the arcsin-square root transformation prior to analysis. A first-order autoregressive correlation structure was assumed.||||0.87
91536730|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|1.02|1.21|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used.||Anti-HPV Type 6||1.21|1.02|<0.001
91536731|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|1.0|1.19|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 11||1.19|1.00|<0.001
91536732|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 16||1.30|1.10|<0.001
91536733|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.08|1.31|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 18||1.31|1.08|<0.001
91536734|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.13|1.37|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 31||1.37|1.13|<0.001
91536735|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 33||1.30|1.10|<0.001
91536736|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.27|||<|0.001|TWO_SIDED|95.0|1.14|1.41|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 45||1.41|1.14|<0.001
91536737|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.05|1.26|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 52||1.26|1.05|<0.001
91536738|NCT01651949|182953015|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.14|1.36|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 58||1.36|1.14|<0.001
91536739|NCT01651949|182953016|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-15.0|-8.0|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Erythema||-8.0|-15.0|<0.001
91536740|NCT01651949|182953016|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-19.1|||<|0.001|TWO_SIDED|95.0|-22.5|-15.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Pain||-15.7|-22.5|<0.001
91536741|NCT01651949|182953016|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-17.3|||<|0.001|TWO_SIDED|95.0|-20.8|-13.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Swelling||-13.7|-20.8|<0.001
91536742|NCT01651949|182953017|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.5||||0.091|TWO_SIDED|95.0|-3.4|0.2|||Miettinen & Nurminen||The incidence of maximum body temperature \>=37.8° C reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Elevated Body Temperature||0.2|-3.4|0.091
91536743|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|0.9|||Miettinen & Nurminen|||Anti-HPV Type 6||0.9|-0.7|<0.001
91536744|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.8|||Miettinen & Nurminen|||Anti-HPV Type 11||0.8|-0.3|<0.001
91536745|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 16||0.7|-0.3|<0.001
91762934|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
91536746|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.4|0.8|||Miettinen & Nurminen|||Anti-HPV Type 18||0.8|-0.4|<0.001
91536747|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-0.4|0.5|||Miettinen & Nurminen|||Anti-HPV Type 31||0.5|-0.4|<0.001
91536748|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 33||0.7|-0.3|<0.001
91536749|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen|||Anti-HPV Type 45||1.0|-0.4|<0.001
91536750|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 52||0.9|-0.2|<0.001
91536751|NCT01651949|182953018|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 58||0.9|-0.2|<0.001
91536752|NCT02155829|182953025|SUPERIORITY|||||||0.442|||||||ANCOVA|ANCOVA covariate included site.||||||0.442
91536753|NCT02155829|182953026|SUPERIORITY|||||||0.994|||||||ANCOVA|ANCOVA covariate included site.||||||0.994
91536754|NCT02155829|182953027|SUPERIORITY|||||||0.684|||||||ANCOVA|ANCOVA covariate included site.||||||0.684
91536755|NCT02155829|182953028|SUPERIORITY|||||||0.913|||||||ANCOVA|ANCOVA covariate included site.||||||0.913
91536756|NCT02155829|182953029|SUPERIORITY|||||||0.746|||||||ANCOVA|ANCOVA covariate included site.||||||0.746
91536757|NCT02155829|182953030|SUPERIORITY|||||||0.057|||||||ANCOVA|ANCOVA covariate included site.||||||0.057
91536758|NCT02155829|182953031|SUPERIORITY|||||||0.0496|||||||ANCOVA|ANCOVA covariate included site.||||||0.0496
91536759|NCT01585038|182953033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.3|TWO_SIDED|95.0|-1.56|2.64|||t-test, 1 sided|||||2.64|-1.56|0.30
91536760|NCT01585038|182953034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.21||||0.35|TWO_SIDED|95.0|-4.71|2.3|||t-test, 2 sided|||||2.30|-4.71|0.35
91536761|NCT01585038|182953035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.41|TWO_SIDED|95.0|-62.49|75.89|||t-test, 2 sided|||||75.89|-62.49|0.41
91536762|NCT01585038|182953036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-194.1||||0.02|TWO_SIDED|95.0|-353.7|-34.6|||t-test, 2 sided|||||-34.6|-353.7|0.02
91536763|NCT00678795|182953037|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.569|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.||0.26|-0.47|0.569
91536764|NCT00678795|182953038|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.76||||0.071|TWO_SIDED|95.0|-1.58|0.07|||ANCOVA|||The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.||0.07|-1.58|0.071
91536765|NCT00678795|182953039|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.28||||0.01|TWO_SIDED|95.0|-0.5|-0.07|||ANCOVA|||The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.||-0.07|-0.50|0.010
91536766|NCT00678795|182953040|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.74|TWO_SIDED|95.0|-0.57|0.41|||ANCOVA|||The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.||0.41|-0.57|0.74
91536767|NCT00678795|182953041|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.9||||0.166|TWO_SIDED|95.0|-1.65|9.46|||ANCOVA|||The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.||9.46|-1.65|0.166
91536768|NCT00678795|182953042|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.16||||0.001|TWO_SIDED|95.0|-1.82|-0.51|||ANCOVA|||The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.||-0.51|-1.82|0.001
91536769|NCT00678795|182953043|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|25.4||||0.002|TWO_SIDED|95.0|10.37|40.42|||Fisher Exact|||For Patient Global Impression of Change, the proportions of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' were compared between treatment groups using Fisher's Exact Test.||40.42|10.37|0.002
91536770|NCT00678795|182953044|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.85||||0.007|TWO_SIDED|95.0|-1.47|-0.23|||ANCOVA|||The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.||-0.23|-1.47|0.007
91536771|NCT00843193|182953067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1955|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.27|0.1955
91536772|NCT00843193|182953067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0193|TWO_SIDED|95.0|-0.34|-0.03|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||-0.03|-0.34|0.0193
91536773|NCT00843193|182953067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.6156|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.14|-0.23|0.6156
91536774|NCT00843193|182953067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.4672|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||Comparison between GSK679586 120 mg/kg and Placebo at Week 12||0.14|-0.31|0.4672
91536775|NCT00843193|182953070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7693|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.08|0.7693
91536776|NCT00843193|182953070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8987|TWO_SIDED|95.0|-0.08|0.09|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||0.09|-0.08|0.8987
91536777|NCT00843193|182953070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.4231|TWO_SIDED|95.0|-0.12|0.05|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.05|-0.12|0.4231
91536778|NCT00843193|182953070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0537|TWO_SIDED|95.0|-0.19|0.0|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 12||0.00|-0.19|0.0537
91536779|NCT03301220|182953116|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.36|0.67|||Log Rank|||||0.67|0.36|<0.0001
91536780|NCT05012644|182953156|OTHER||Odds Ratio (OR)|1.266|||||TWO_SIDED|95.0|0.715|2.241||||||||2.241|0.715|
91762935|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0006
91536781|NCT05012644|182953157|OTHER||Odds Ratio (OR)|1.508|||||TWO_SIDED|95.0|0.819|2.774||||||||2.774|0.819|
91536782|NCT04845620|182953158|SUPERIORITY||Odds Ratio (OR)|2.89|||<|0.0001|TWO_SIDED|97.5|1.648|5.064|||Cochran-Mantel-Haenszel|Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations|Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations|vIGA Success at Week 4||5.064|1.648|<0.0001
91536783|NCT04845620|182953159|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|97.5|1.662|5.772|||Chi-squared|Multiple imputation of missing observations|Multiple imputation of missing observations|vIGA Success at Week 4 in Participants with Moderate Baseline vIGA||5.772|1.662|<0.0001
91536784|NCT04845620|182953160|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|97.5|1.578|3.87|||Cochran-Mantel-Haenszel|Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations|Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations|EASI-75 at Week 4||3.870|1.578|<0.0001
91536785|NCT04845620|182953161|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.0001|TWO_SIDED|97.5|1.98|5.475|||Cochran-Mantel-Haenszel|Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations|Stratified by randomized baseline vIGA-AD with multiple imputation of missing observations|vIGA Score of 'Clear' or 'Almost Clear' at Week 4||5.475|1.980|<0.0001
91536786|NCT04845620|182953162|SUPERIORITY||Odds Ratio (OR)|3.74|||<|0.0001|TWO_SIDED|97.5|1.912|7.313|||Cochran-Mantel-Haenszel|Stratified by baseline vIGA-AD with multiple imputation of missing observations|Stratified by baseline vIGA-AD with multiple imputation of missing observations|||7.313|1.912|<0.0001
91536787|NCT04845620|182953163|SUPERIORITY||Odds Ratio (OR)|11.44|||<|0.0001|TWO_SIDED|97.5|2.216|59.101|||Cochran-Mantel-Haenszel|Stratified by randomized baseline vIGA-AD with multiple imputation of missing data|Stratified by randomized baseline vIGA-AD with multiple imputation of missing data|vIGA-AD Success at Week 1||59.101|2.216|<0.0001
91536788|NCT04845620|182953164|SUPERIORITY||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|97.5|2.137|6.761|||Cochran-Mantel-Haenszel|Stratified by randomized baseline vIGA-AD with multiple imputation of missing data|Stratified by randomized baseline vIGA-AD with multiple imputation of missing data|vIGA-AD of Clear or Almost Clear at Week 2||6.761|2.137|<0.0001
91536789|NCT04845620|182953165|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.0001|TWO_SIDED|97.5|2.342|14.113|||Cochran-Mantel-Haenszel|Stratified by baseline vIGA-AD with multiple imputation of missing data|Stratified by baseline vIGA-AD with multiple imputation of missing data|vIGA-AD of Clear or Almost Clear at Week 2||14.113|2.342|<0.0001
91536790|NCT00708097|182953166|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.98||||0.5757|TWO_SIDED|95.0|-5.0|8.97||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.97|-5.00|0.5757
91536791|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.5387|TWO_SIDED|95.0|-4.79|9.14||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.14|-4.79|0.5387
91536792|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.79||||0.4306|TWO_SIDED|95.0|-4.18|9.77||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.77|-4.18|0.4306
91762936|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0979|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0979
91762937|NCT00445770|183416309|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
91762938|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0001
91536793|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.07|||<|0.0001|TWO_SIDED|95.0|-32.09|-18.06||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-18.06|-32.09|<0.0001
91536794|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.9567|TWO_SIDED|95.0|-6.71|7.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.09|-6.71|0.9567
91536795|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.81||||0.8188|TWO_SIDED|95.0|-6.14|7.76||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.76|-6.14|0.8188
91536796|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.06|||<|0.0001|TWO_SIDED|95.0|-34.03|-20.08||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.08|-34.03|<0.0001
91536797|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62||||0.8599|TWO_SIDED|95.0|-6.28|7.51||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.51|-6.28|0.8599
91536798|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-34.2|-20.3||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.30|-34.20|<0.0001
91536799|NCT00708097|182953167|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.87|||<|0.0001|TWO_SIDED|95.0|-34.84|-20.89||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.89|-34.84|<0.0001
91536800|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.45||||0.5451|TWO_SIDED|95.0|-6.15|3.26||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||3.26|-6.15|0.5451
91536801|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.5||||0.1433|TWO_SIDED|95.0|-1.2|8.19||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.19|-1.20|0.1433
91536802|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.47||||0.002|TWO_SIDED|95.0|2.78|12.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||12.16|2.78|0.0020
91536803|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.52|||<|0.0001|TWO_SIDED|95.0|18.79|28.25||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||28.25|18.79|<0.0001
91536804|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.94||||0.0373|TWO_SIDED|95.0|0.29|9.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.59|0.29|0.0373
91536805|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.92||||0.0002|TWO_SIDED|95.0|4.24|13.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||13.59|4.24|0.0002
91536806|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|24.97|||<|0.0001|TWO_SIDED|95.0|20.27|29.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||29.66|20.27|<0.0001
91536807|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.98||||0.0925|TWO_SIDED|95.0|-0.66|8.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.61|-0.66|0.0925
91536808|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.03|||<|0.0001|TWO_SIDED|95.0|15.35|24.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||24.70|15.35|<0.0001
91536809|NCT00708097|182953168|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.05|||<|0.0001|TWO_SIDED|95.0|11.36|20.74||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||20.74|11.36|<0.0001
91536810|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01||||0.9697|TWO_SIDED|95.0|-106.34|102.32||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||102.32|-106.34|0.9697
91536811|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|106.9||||0.044|TWO_SIDED|95.0|2.92|210.87||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||210.87|2.92|0.0440
91536812|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.92||||0.0026|TWO_SIDED|95.0|56.96|264.88||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||264.88|56.96|0.0026
91536813|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|222.47|||<|0.0001|TWO_SIDED|95.0|117.58|327.36||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||327.36|117.58|<0.0001
91536814|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|108.91||||0.0382|TWO_SIDED|95.0|5.98|211.83||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||211.83|5.98|0.0382
91536815|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|162.93||||0.0021|TWO_SIDED|95.0|59.68|266.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||266.18|59.68|0.0021
91536816|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|224.48|||<|0.0001|TWO_SIDED|95.0|120.51|328.46||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||328.46|120.51|<0.0001
91536817|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|54.03||||0.3003|TWO_SIDED|95.0|-48.56|156.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||156.61|-48.56|0.3003
91536818|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.55||||0.2432|TWO_SIDED|95.0|-42.14|165.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||165.24|-42.14|0.2432
91536819|NCT00708097|182953169|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|115.58||||0.0289|TWO_SIDED|95.0|12.02|219.13||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||219.13|12.02|0.0289
91536820|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.9||||0.9293|TWO_SIDED|95.0|-322.47|294.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||294.66|-322.47|0.9293
91536821|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|575.71||||0.0003|TWO_SIDED|95.0|268.24|883.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||883.17|268.24|0.0003
91536822|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|637.67|||<|0.0001|TWO_SIDED|95.0|330.3|945.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||945.03|330.30|<0.0001
91536823|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1813.29|||<|0.0001|TWO_SIDED|95.0|1503.03|2123.54||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2123.54|1503.03|<0.0001
91536824|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|589.61||||0.0002|TWO_SIDED|95.0|285.31|893.92|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||893.92|285.31|0.0002
91536825|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|651.57|||<|0.0001|TWO_SIDED|95.0|346.44|956.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||956.70|346.44|<0.0001
91536826|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1827.19|||<|0.0001|TWO_SIDED|95.0|1519.78|2134.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2134.60|1519.78|<0.0001
91762939|NCT00445770|183416309|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1740
91762940|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.||Week 2||||<0.0001
91762941|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 2||||<0.0001
91762942|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.|ANCOVA|||Week 2||||0.0274
91762943|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
91762944|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
91536827|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.96||||0.6874|TWO_SIDED|95.0|-241.25|365.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||365.17|-241.25|0.6874
91536828|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1237.58|||<|0.0001|TWO_SIDED|95.0|931.46|1543.7|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1543.70|931.46|<0.0001
91536829|NCT00708097|182953170|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1175.62|||<|0.0001|TWO_SIDED|95.0|869.15|1482.1||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1482.10|869.15|<0.0001
91536830|NCT03425643|182953171|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|1e-05|TWO_SIDED|95.0|0.48|0.72||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.72|0.48|<0.00001
91536831|NCT03425643|182953172|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00517|TWO_SIDED|95.0|0.56|0.93||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.93|0.56|0.00517
91536832|NCT03425643|182953173|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Percentage|19.2|||<|1e-05|TWO_SIDED|95.0|13.9|24.7|||Stratified Miettinen and Nurminen|||||24.7|13.9|<0.00001
91536833|NCT03425643|182953174|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Pertentage|14.2|||<|1e-05|TWO_SIDED|95.0|10.1|18.7|||Stratified Miettinen and Nurminen|||||18.7|10.1|<0.00001
91536834|NCT03425643|182953175|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|1.43||||0.3611|TWO_SIDED|95.0|-1.64|4.49|||t-test, 2 sided|||||4.49|-1.64|0.3611
91536835|NCT03425643|182953176|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|2.22||||0.1197|TWO_SIDED|95.0|-0.58|5.02|||t-test, 2 sided|||||5.02|-0.58|0.1197
91536836|NCT00726596|182953185|SUPERIORITY|||||||0.6789|||||||t-test, 1 sided|||||||.6789
91536837|NCT00482729|182953190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||<|0.001||95.0|-0.78|-0.43|||ANCOVA|Model terms: treatment, baseline A1C||||-0.43|-0.78|<0.001
91536838|NCT00482729|182953191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.001||95.0|1.6|2.69||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|ANCOVA|Model terms: treatment, baseline A1C|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|||2.69|1.60|<0.001
91536839|NCT00482729|182953192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||<|0.001||95.0|-22.4|-9.0|||ANCOVA|Model terms: treatment, baseline A1C||||-9.0|-22.4|<0.001
91536840|NCT00482729|182953193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||||95.0|-0.67|-0.3|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.|||-0.30|-0.67|
91536841|NCT00482729|182953194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||||95.0|1.63|2.73|||||This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C|||2.73|1.63|
91536842|NCT01549314|182953203|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.77
91536843|NCT01549314|182953203|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.82
91536844|NCT01549314|182953204|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.64
91536845|NCT01549314|182953204|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.78
91536846|NCT01549314|182953205|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.86
91536847|NCT01549314|182953205|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.99
91536848|NCT00954707|182953207|SUPERIORITY_OR_OTHER||Rate of TLF at 12-month (%)|6.4|||||TWO_SIDED|95.0|5.5|7.5||||||||7.5|5.5|
91536849|NCT00954707|182953208|SUPERIORITY_OR_OTHER||Rate of device success (%)|98.0|||||TWO_SIDED|95.0|97.4|98.4||||||||98.4|97.4|
91536850|NCT00954707|182953209|SUPERIORITY_OR_OTHER||Rate of lesion success (%)|99.8|||||TWO_SIDED|95.0|99.6|99.9||||||||99.9|99.6|
91536851|NCT00954707|182953210|SUPERIORITY_OR_OTHER||Rate of procedure success (%)|97.7|||||TWO_SIDED|95.0|97.0|98.2||||||||98.2|97.0|
91536852|NCT00954707|182953211|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TLR (%)|4.2|||||TWO_SIDED|95.0|3.45|5.13||||||||5.13|3.45|
91536853|NCT00954707|182953212|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TVR (%)|5.8|||||TWO_SIDED|95.0|4.87|6.81||||||||6.81|4.87|
91536854|NCT00954707|182953213|SUPERIORITY_OR_OTHER||Rate of Target vessel failure (%)|7.92|||||TWO_SIDED|95.0|6.85|9.09||||||||9.09|6.85|
91536855|NCT00954707|182953214|SUPERIORITY_OR_OTHER||Rate of MACE (%)|7.41|||||TWO_SIDED|95.0|6.37|8.55||||||||8.55|6.37|
91536856|NCT00954707|182953215|SUPERIORITY_OR_OTHER||Rate of protocol defined ST (%)|0.91|||||TWO_SIDED|95.0|0.56|1.38||||||||1.38|0.56|
91536857|NCT00954707|182953216|SUPERIORITY_OR_OTHER||Rate of ARC defined ST (%)|1.12|||||TWO_SIDED|95.0|0.74|1.64||||||||1.64|0.74|
91536858|NCT00954707|182953217|SUPERIORITY_OR_OTHER||Rate of major bleeding complications (%)|3.07|||||TWO_SIDED|95.0|2.4|3.85||||||||3.85|2.40|
91536859|NCT00954707|182953218|SUPERIORITY_OR_OTHER||Rate of cardiac death (%)|0.78|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
91536860|NCT00954707|182953219|SUPERIORITY_OR_OTHER||Rate of non-cardiac death (%)|0.69|||||TWO_SIDED|95.0|0.4|1.12||||||||1.12|0.40|
91536861|NCT00531518|182953228|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||The final analysis included adjstment for site and baseline sum psychotic symptom score.|Mixed Models Analysis|||The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.||||.0034
91536862|NCT03265210|182953229|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.39|TWO_SIDED|95.0|-4.95|1.95|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Baseline||1.95|-4.95|0.39
91536863|NCT03265210|182953229|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.03|TWO_SIDED|95.0|-7.19|-0.39|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|6 weeks||-0.39|-7.19|0.03
91536864|NCT03265210|182953229|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.42|TWO_SIDED|95.0|-5.38|2.26|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|9 weeks||2.26|-5.38|0.42
91536865|NCT03265210|182953229|SUPERIORITY||Mean Difference (Final Values)|-3.37||||0.07|TWO_SIDED|95.0|-7.02|0.28|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|12 weeks||0.28|-7.02|0.07
91536866|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.17|TWO_SIDED|95.0|-1.81|0.33|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, Baseline||0.33|-1.81|0.17
91536867|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.25|TWO_SIDED|95.0|-1.68|0.44|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 6 weeks||0.44|-1.68|0.25
91536868|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.09|TWO_SIDED|95.0|-2.29|0.17|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 9 weeks||0.17|-2.29|0.09
91536869|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.05|TWO_SIDED|95.0|-2.19|0.01|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 12 weeks||0.01|-2.19|0.05
91536870|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.02|TWO_SIDED|95.0|-5.9|-0.48|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, Baseline||-0.48|-5.90|0.02
91536871|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.003|TWO_SIDED|95.0|-7.06|-1.54|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 6 weeks||-1.54|-7.06|0.003
91536872|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-5.95||||0.0001|TWO_SIDED|95.0|-8.85|-3.05|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 9 weeks||-3.05|-8.85|0.0001
91536873|NCT03265210|182953230|SUPERIORITY||Mean Difference (Final Values)|-4.35||||0.007|TWO_SIDED|95.0|-7.46|-1.24|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 12 weeks||-1.24|-7.46|0.007
91536874|NCT03265210|182953231|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0003|TWO_SIDED|95.0|0.53|1.69|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1||1.69|0.53|0.0003
91536875|NCT03265210|182953231|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.001|TWO_SIDED|95.0|0.21|0.83|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2||0.83|0.21|0.001
91536876|NCT03265210|182953231|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.002|TWO_SIDED|95.0|0.36|1.56|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 3||1.56|0.36|0.002
91536877|NCT00738699|182953291|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.836|TWO_SIDED|95.0|0.88|1.46||One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).|Log Rank||Stratified as described above.|||1.46|0.88|0.8360
91536878|NCT00738699|182953292|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11||||0.7568|TWO_SIDED|95.0|0.83|1.48||One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.|Log Rank||Stratified as described above|||1.48|0.83|0.7568
91536879|NCT00738699|182953293|SUPERIORITY_OR_OTHER||Difference|-7.4||||0.0399|TWO_SIDED|95.0|-14.1|-0.7||Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.|Cochran-Mantel-Haenszel||(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.|||-0.7|-14.1|0.0399
91536880|NCT00549848|182953297|SUPERIORITY|||||||0.778|||||||Cochran-Mantel-Haenszel|||||||0.778
91536881|NCT03670602|182953311|SUPERIORITY|||||||0.0035||||||This is for the treatment group x time effect, or if treatment influenced improvements in delay discounting across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate.||||0.0035
91536882|NCT03670602|182953311|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if delay discounting improved across all three timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
91536883|NCT03670602|182953312|SUPERIORITY|||||||0.85||||||This is for the treatment group x time effect, or if treatment differentially influenced weight across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.85
91536884|NCT03670602|182953312|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if time influenced changes in weight, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
91536885|NCT03670602|182953313|SUPERIORITY|||||||0.79||||||This is for the treatment group x time effect, or if treatment group influenced change in hBa1c across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.79
91536886|NCT03670602|182953313|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if hBa1c changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
91536887|NCT03670602|182953314|SUPERIORITY|||||||0.201||||||This is for the treatment group x time effect, or if treatment differentially influenced medication adherence across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.201
91536888|NCT03670602|182953314|SUPERIORITY|||||||0.315||||||This is for the time effect, or if timepoint influenced medication adherence across all timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.315
91536889|NCT03670602|182953315|SUPERIORITY|A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||||0.345||||||This is for the treatment group x time effect, or if treatment group influenced change in percent of time engaged in moderate-to-vigorous physical activity (MVPA) across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||||||0.345
91536890|NCT03670602|182953315|SUPERIORITY|||||||0.0003||||||This is for the time effect, or if percent of time engaged in moderate-to-vigorous physical activity (MVPA) changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.0003
91536891|NCT03670602|182953316|SUPERIORITY|||||||0.007||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in calorie intake across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.007
91762945|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0344|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||0.0344
91536892|NCT03670602|182953316|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in calorie intake, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
91536893|NCT03670602|182953317|SUPERIORITY|||||||0.774||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in working memory across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.774
91762946|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
91762947|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
91762948|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0293|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||0.0293
91536894|NCT03670602|182953317|SUPERIORITY|||||||0.019||||||This is for the time effect, or if time influenced changes in working memory, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.019
91536895|NCT03670602|182953318|SUPERIORITY|||||||0.65||||||This is for the treatment group x time effect, or if treatment differentially influenced relative reinforcing efficacy of unhealthy food across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.650
91536896|NCT03670602|182953318|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in relative reinforcing efficacy of unhealthy food, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
91536897|NCT00957658|182953322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 6%|||||<|0.0001|||||||Asymptotic WALD test|||Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years||||<.0001
91536898|NCT00957658|182953325|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Improvement from preop to 2 year and preop to 5 year||||<.0001
91536899|NCT00957658|182953326|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year||||<.0001
91536900|NCT00957658|182953326|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Mental Score preop to 2 years||||<.0001
91536901|NCT00957658|182953326|SUPERIORITY_OR_OTHER|||||||0.0004|||||||t-test, 2 sided|||Compare SF-12 Mental Score preop to 5 years||||.0004
91536902|NCT00957658|182953327|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Compare LEAS score preop to 2 years and preop to 5 years||||<.0001
91536903|NCT00957658|182953330|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)||||<.0001
91536904|NCT00957658|182953331|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||Compare Wrist DXA T-score preop to 5 years||||.0002
91536905|NCT03383887|182953332|SUPERIORITY||Median Difference (Final Values)|2.7||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
91536906|NCT03383887|182953333|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
91536907|NCT00300456|182953334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
91536908|NCT00300456|182953334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
91536909|NCT00300456|182953335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91536910|NCT00300456|182953335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91536911|NCT00300456|182953336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91536912|NCT00300456|182953336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
91536913|NCT01806714|182953421|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||<|0.04|TWO_SIDED|95.0|1.0|1.6|||clustered stratified Proportional Hazard||We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.|||1.6|1.0|<0.04
91536914|NCT01120275|182953444|SUPERIORITY_OR_OTHER||6-month PFS|0.09|||||TWO_SIDED|95.0|0.02|0.22||||||6-month progression free survival (PFS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.22|0.02|
91536915|NCT01120275|182953445|SUPERIORITY_OR_OTHER||1-year OS|0.5|||||TWO_SIDED|95.0|0.32|0.66||||||1-year overall survival (OS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.66|0.32|
91536916|NCT01156116|182953461|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.03
91536917|NCT01156116|182953462|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.04
91536918|NCT01156116|182953463|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.009
91536919|NCT01156116|182953464|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||<0.001
91536920|NCT02057718|182953465|OTHER|Null hypothesis (H0): mean change from baseline to Week 13 is zero. The null hypothesis was tested for each of the 2 PFIC subgroups and overall; the change in the overall population is presented here.|Mean Difference (Net)|-23.304|STANDARD_DEVIATION|160.9748|||TWO_SIDED|95.0|-82.35|35.742||||||This analysis shows the change from baseline to Week 13 in sBA levels for the overall Modified Intent-to-treat Population. Even though a comparison of PFIC1 vs PFIC2 (overall) is noted, the results are the change from baseline for all participants and is not comparative.||35.742|-82.35|
91536921|NCT00434018|182953474|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
91536922|NCT03068611|182953491|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||.90
91536923|NCT03068611|182953492|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||.54
91536924|NCT03068611|182953493|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|Data were log-transformed transformed due to positive skewness||||||.36
91536925|NCT03068611|182953494|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Data were log-transformed to correct positive skewness||||||.92
91536926|NCT04567888|182953507|SUPERIORITY||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.88|-0.95||Threshold for statistical significance set to .050.|Repeated-measures Multilevel Models|||||-0.95|-1.88|<.001
91536927|NCT04567888|182953508|SUPERIORITY||Slope|-0.54|||<|0.001|TWO_SIDED|95.0|-0.78|-0.3||Threshold for statistical significance was set to .050.|Repeated-measures Multilevel Models|||||-0.30|-0.78|< .001
91536928|NCT01157182|182953509|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.94|||||TWO_SIDED|90.0|97.63|108.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.55|97.63|
91536929|NCT01157182|182953510|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.4|||||TWO_SIDED|90.0|95.15|101.76|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.76|95.15|
91536930|NCT01157182|182953511|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.73|||||TWO_SIDED|90.0|95.33|102.26|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.26|95.33|
91536931|NCT01157182|182953512|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.51|||||TWO_SIDED|90.0|88.64|96.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||96.55|88.64|
91536932|NCT01157182|182953513|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.66|||||TWO_SIDED|90.0|92.6|98.81|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.81|92.60|
91536933|NCT01157182|182953514|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.71|||||TWO_SIDED|90.0|92.62|98.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.91|92.62|
91536934|NCT01157182|182953515|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.41|||||TWO_SIDED|90.0|88.65|96.33|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||96.33|88.65|
91762949|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
91762950|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
91762951|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0452|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||0.0452
91536935|NCT01157182|182953516|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.67|||||TWO_SIDED|90.0|92.68|98.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.77|92.68|
91536936|NCT01157182|182953517|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.73|||||TWO_SIDED|90.0|92.68|98.88|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.88|92.68|
91536937|NCT01157182|182953518|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.21|||||TWO_SIDED|90.0|84.62|98.31|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.31|84.62|
91536938|NCT01157182|182953519|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.11|||||TWO_SIDED|90.0|89.04|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|89.04|
91536939|NCT01157182|182953520|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.48|||||TWO_SIDED|90.0|90.7|104.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.76|90.70|
91536940|NCT01157182|182953521|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|89.78|98.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.81|89.78|
91536941|NCT01157182|182953522|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.99|||||TWO_SIDED|90.0|92.73|99.36|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.36|92.73|
91536942|NCT01157182|182953523|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.22|||||TWO_SIDED|90.0|93.62|100.96|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.96|93.62|
91536943|NCT01157182|182953524|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.73|||||TWO_SIDED|90.0|84.46|99.62|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.62|84.46|
91536944|NCT01157182|182953525|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.47|||||TWO_SIDED|90.0|88.37|103.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.14|88.37|
91536945|NCT01157182|182953526|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.63|||||TWO_SIDED|90.0|88.1|103.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.81|88.10|
91536946|NCT01157182|182953527|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.15|||||TWO_SIDED|90.0|89.56|98.98|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.98|89.56|
91536947|NCT01157182|182953528|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.01|||||TWO_SIDED|90.0|92.14|100.04|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.04|92.14|
91536948|NCT01157182|182953529|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.75|||||TWO_SIDED|90.0|92.75|100.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.93|92.75|
91536949|NCT00383188|182953541|SUPERIORITY||Difference in percentage|8.05|STANDARD_ERROR_OF_MEAN|7.97||0.3131|TWO_SIDED|95.0|-7.565|23.664|||Chi-squared|||||23.664|-7.565|0.3131
91536950|NCT00383188|182953541|SUPERIORITY||Difference in percentage|10.81|STANDARD_ERROR_OF_MEAN|7.86||0.1719|TWO_SIDED|95.0|-4.602|26.224|||Chi-squared|||||26.224|-4.602|0.1719
91536951|NCT00383188|182953541|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|95.0|-8.123|27.799|||Chi-squared|||||27.799|-8.123|0.2783
91536952|NCT00383188|182953541|SUPERIORITY||Difference in percentage|8.92|STANDARD_ERROR_OF_MEAN|9.43||0.3381|TWO_SIDED|95.0|-9.566|27.404|||Chi-squared|||||27.404|-9.566|0.3381
91536953|NCT00383188|182953542|SUPERIORITY||Difference in percentage|1.04|STANDARD_ERROR_OF_MEAN|5.96||0.8619|TWO_SIDED|90.0|-8.733|10.845|||Chi-squared|||Week 1||10.845|-8.733|0.8619
91536954|NCT00383188|182953542|SUPERIORITY||Difference in percentage|7.24|STANDARD_ERROR_OF_MEAN|6.33||0.2546|TWO_SIDED|90.0|-3.176|17.651|||Chi-squared|||Week 1||17.651|-3.176|0.2546
91536955|NCT00383188|182953542|SUPERIORITY||Difference in percentage|14.02|STANDARD_ERROR_OF_MEAN|7.96||0.0644|TWO_SIDED|90.0|0.921|27.115|||Chi-squared|||Week 1||27.115|0.921|0.0644
91536956|NCT00383188|182953542|SUPERIORITY||Difference in percentage|1.5|STANDARD_ERROR_OF_MEAN|7.07||0.8304|TWO_SIDED|90.0|-10.13|13.125|||Chi-squared|||Week 1||13.125|-10.13|0.8304
91536957|NCT00383188|182953542|SUPERIORITY||Difference in percentage|6.11|STANDARD_ERROR_OF_MEAN|7.45||0.4123|TWO_SIDED|90.0|-6.15|18.371|||Chi-squared|||Week 2||18.371|-6.150|0.4123
91536958|NCT00383188|182953542|SUPERIORITY||Difference in percentage|5.41|STANDARD_ERROR_OF_MEAN|7.29||0.4591|TWO_SIDED|90.0|-6.581|17.392|||Chi-squared|||Week 2||17.392|-6.581|0.4591
91536959|NCT00383188|182953542|SUPERIORITY||Difference in percentage|16.58|STANDARD_ERROR_OF_MEAN|8.93||0.0585|TWO_SIDED|90.0|1.89|31.28|||Chi-squared|||Week 2||31.280|1.890|0.0585
91536960|NCT00383188|182953542|SUPERIORITY||Difference in percentage|15.68|STANDARD_ERROR_OF_MEAN|9.21||0.0808|TWO_SIDED|90.0|0.522|30.829|||Chi-squared|||Week 2||30.829|0.522|0.0808
91536961|NCT00383188|182953542|SUPERIORITY||Difference in percentage|4.86|STANDARD_ERROR_OF_MEAN|7.62||0.524|TWO_SIDED|90.0|-7.684|17.398|||Chi-squared|||Week 4||17.398|-7.684|0.5240
91536962|NCT00383188|182953542|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.72||0.0571|TWO_SIDED|90.0|2.172|27.588|||Chi-squared|||Week 4||27.588|2.172|0.0571
91536963|NCT00383188|182953542|SUPERIORITY||Difference in percentage|16.15|STANDARD_ERROR_OF_MEAN|9.08||0.0712|TWO_SIDED|90.0|1.222|31.087|||Chi-squared|||Week 4||31.087|1.222|0.0712
91536964|NCT00383188|182953542|SUPERIORITY||Difference in percentage|20.47|STANDARD_ERROR_OF_MEAN|9.43||0.0279|TWO_SIDED|90.0|4.956|35.99|||Chi-squared|||Week 4||35.990|4.956|0.0279
91536965|NCT00383188|182953542|SUPERIORITY||Difference in Percentage|-2.1|STANDARD_ERROR_OF_MEAN|7.67||0.7848|TWO_SIDED|90.0|-14.71|10.515|||Chi-squared|||Week 8||10.515|-14.71|0.7848
91536966|NCT00383188|182953542|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.91||0.0632|TWO_SIDED|90.0|1.86|27.869|||Chi-squared|||Week 8||27.869|1.860|0.0632
91536967|NCT00383188|182953542|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|90.0|-5.237|24.893|||Chi-squared|||Week 8||24.893|-5.237|0.2783
91536968|NCT00383188|182953542|SUPERIORITY||Difference in percentage|16.42|STANDARD_ERROR_OF_MEAN|9.55||0.0828|TWO_SIDED|90.0|0.703|32.135|||Chi-squared|||Week 8||32.135|0.703|0.0828
91536969|NCT00383188|182953542|SUPERIORITY||Difference in percentage|-2.72|STANDARD_ERROR_OF_MEAN|8.54||0.7505|TWO_SIDED|90.0|-16.77|11.328|||Chi-squared|||Week 16||11.328|-16.77|0.7505
91536970|NCT00383188|182953542|SUPERIORITY||Difference in percentage|1.43|STANDARD_ERROR_OF_MEAN|8.35||0.8641|TWO_SIDED|90.0|-12.3|15.156|||Chi-squared|||Week 16||15.156|-12.30|0.8641
91536971|NCT00383188|182953542|SUPERIORITY||Difference in percentage|3.31|STANDARD_ERROR_OF_MEAN|9.99||0.7399|TWO_SIDED|90.0|-13.12|19.734|||Chi-squared|||Week 16||19.734|-13.12|0.7399
91536972|NCT00383188|182953542|SUPERIORITY||Difference in percentage|-12.48|STANDARD_ERROR_OF_MEAN|9.42||0.1996|TWO_SIDED|90.0|-27.98|3.018|||Chi-squared|||Week 16||3.018|-27.98|0.1996
91536973|NCT00383188|182953543|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|1.48||0.2982|TWO_SIDED|90.0|-0.944|3.929|||Chi-squared|||Week 1||3.929|-0.944|0.2982
91762952|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
91762953|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
91762954|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||0.0313
91513853|NCT04096560|182899665|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-16.96|-9.09||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-9.09|-16.96|<0.001
91513854|NCT04096560|182899666|SUPERIORITY||IRR|0.05|||=|0.002|TWO_SIDED|95.0|0.007|0.317||The incidence rate was the exponentiated LS means and the incidence rate ratio (IRR) was the exponentiated LS mean differences from the generalized estimating equation (GEE) Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.317|0.007|=0.002
91513855|NCT04096560|182899666|SUPERIORITY||IRR|0.2|||=|0.019|TWO_SIDED|95.0|0.05|0.767||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.767|0.050|=0.019
91513856|NCT04096560|182899666|SUPERIORITY||IRR|0.15|||=|0.001|TWO_SIDED|95.0|0.047|0.482||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.482|0.047|=0.001
91513857|NCT00534352|182899677|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|95.47||||||90.0|82.77|110.1||No p-values.|Mixed Models Analysis (Cmin)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmin. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.1|82.77|
91513858|NCT00534352|182899677|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|102.6||||||90.0|92.91|113.3||No p-values.|Mixed Models Analysis (Cmax)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||113.3|92.91|
91513859|NCT00534352|182899677|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|LS means of ratios|98.97||||||90.0|89.23|109.8||No p-values.|Mixed Models Analysis (AUC24)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||109.8|89.23|
91513860|NCT00534352|182899677|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|99.3||||||90.0|89.39|110.3||No p-values.|Mixed Models Analysis (Css,av)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.3|89.39|
91513861|NCT00833924|182899723|SUPERIORITY_OR_OTHER||Rate of 30-day freedom from MAE|99.2|||<|0.01|TWO_SIDED|95.0|95.4|100.0|||Exact binomial test|||Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).||100|95.4|<0.01
91513862|NCT00833924|182899724|SUPERIORITY_OR_OTHER||12-month Device Success Rate|97.3|||<|0.01|TWO_SIDED|95.0|92.4|99.4|||Exact binomial test|||Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).||99.4|92.4|<0.01
91513863|NCT01144338|182899761|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.91||||0.061|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||||1.004|0.832|0.061
91513864|NCT01144338|182899762|NON_INFERIORITY|Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR \< 1.3|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.||1.004|0.832|< 0.001
91513865|NCT01144338|182899763|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.86||||0.016|TWO_SIDED|95.0|0.77|0.97|||Regression, Cox|||||0.97|0.77|0.016
91513866|NCT01144338|182899764|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.88||||0.096|TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|||||1.02|0.76|0.096
91513867|NCT01144338|182899765|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.97||||0.622|TWO_SIDED|95.0|0.85|1.1|||Regression, Cox|||||1.10|0.85|0.622
91513868|NCT01144338|182899766|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.85||||0.095|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox|||||1.03|0.70|0.095
91536974|NCT00383188|182953543|SUPERIORITY||Difference in percentage|1.41|STANDARD_ERROR_OF_MEAN|1.4||0.3122|TWO_SIDED|90.0|-0.892|3.709|||Chi-squared|||Week 1||3.709|-0.892|0.3122
91536975|NCT00383188|182953543|SUPERIORITY||Difference in percentage|4.65|STANDARD_ERROR_OF_MEAN|3.21||0.0649|TWO_SIDED|90.0|-0.631|9.934|||Chi-squared|||Week 1||9.934|-0.631|0.0649
91513869|NCT01144338|182899767|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.402
91513870|NCT01144338|182899768|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.94||||0.485|TWO_SIDED|95.0|0.78|1.13|||Regression, Cox|||||1.13|0.78|0.485
91513871|NCT04796610|182899769|SUPERIORITY||Odds Ratio (OR)|0.55||||0.49|TWO_SIDED|95.0|0.1|2.98|||Regression, Logistic|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||2.98|.1|0.49
91513872|NCT04796610|182899770|SUPERIORITY||Odds Ratio (OR)|16.82||||0.011|TWO_SIDED|95.0|1.93|146.91||Model is adjusted for participant age|Regression, Logistic||Results are presented for an indicator where 0=control and 1=intervention|||146.91|1.93|.011
91513873|NCT04796610|182899771|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.07|0.97|||Regression, Linear|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||0.97|0.07|.03
91513874|NCT02059148|182899811|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.24|||||TWO_SIDED|90.0|1.11|1.38||||||||1.38|1.11|
91513875|NCT02059148|182899812|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.05|1.23||||||||1.23|1.05|
91513876|NCT02059148|182899813|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.95||||0.0006|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|1.00|0.0006
91513877|NCT00856583|182899848|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% confidence interval (CI) for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 patient years of exposure (PYE) were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|1.117||||0.05|TWO_SIDED|90.0|0.831|1.5|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.||1.500|0.831|0.05
91513878|NCT00856583|182899848|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% CI for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 PYE were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|90.0|0.684|1.405|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.||1.405|0.684|<0.05
91513879|NCT00856583|182899849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84||||0.0022|TWO_SIDED|95.0|1.45|5.55|||Cox Proportional Hazard|Adjusted: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), region, year since start of enrollment||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||5.55|1.45|0.0022
91513880|NCT00856583|182899850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.63|4.78|||Cox Proportional Hazard|Adjusted for: age and sex.||The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.78|0.63|0.29
91513881|NCT00856583|182899851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.34|TWO_SIDED|95.0|0.36|1.41|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.41|0.36|0.34
91513882|NCT00856583|182899852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.26|TWO_SIDED|95.0|0.4|1.28|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.28|0.40|0.26
91513883|NCT00856583|182899853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.13||||0.081|TWO_SIDED|95.0|0.91|4.98|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy).||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.98|0.91|0.081
91513884|NCT00856583|182899854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.24|TWO_SIDED|95.0|0.33|1.32|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.32|0.33|0.24
91536976|NCT00383188|182953543|SUPERIORITY||Difference in percentage|5.13|STANDARD_ERROR_OF_MEAN|3.53||0.0525|TWO_SIDED|90.0|-0.681|10.938|||Chi-squared|||Week 1||10.938|-0.681|0.0525
91536977|NCT00383188|182953543|SUPERIORITY||Difference in percentage|4.45|STANDARD_ERROR_OF_MEAN|3.12||0.1481|TWO_SIDED|90.0|-0.681|9.573|||Chi-squared|||Week 2||9.573|-0.681|0.1481
91536978|NCT00383188|182953543|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|3.66||0.0292|TWO_SIDED|90.0|2.093|14.124|||Chi-squared|||Week 2||14.124|2.093|0.0292
91536979|NCT00383188|182953543|SUPERIORITY||Difference in percentage|10.01|STANDARD_ERROR_OF_MEAN|4.97||0.0167|TWO_SIDED|90.0|1.839|18.186|||Chi-squared|||Week 2||18.186|1.839|0.0167
91536980|NCT00383188|182953543|SUPERIORITY||Difference in percentage|11.15|STANDARD_ERROR_OF_MEAN|5.4||0.011|TWO_SIDED|90.0|2.269|20.029|||Chi-squared|||Week 2||20.029|2.269|0.0110
91536981|NCT00383188|182953543|SUPERIORITY||Difference in percentage|-2.51|STANDARD_ERROR_OF_MEAN|3.31||0.455|TWO_SIDED|90.0|-7.959|2.946|||Chi-squared|||Week 4||2.946|-7.959|0.4550
91536982|NCT00383188|182953543|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|4.76||0.0919|TWO_SIDED|90.0|0.271|15.946|||Chi-squared|||Week 4||15.946|0.271|0.0919
91536983|NCT00383188|182953543|SUPERIORITY||Difference in percentage|12.78|STANDARD_ERROR_OF_MEAN|6.38||0.0264|TWO_SIDED|90.0|2.28|23.272|||Chi-squared|||Week 4||23.272|2.280|0.0264
91536984|NCT00383188|182953543|SUPERIORITY||Difference in percentage|12.09|STANDARD_ERROR_OF_MEAN|6.56||0.0369|TWO_SIDED|90.0|1.308|22.881|||Chi-squared|||Week 4||22.881|1.308|0.0369
91536985|NCT00383188|182953543|SUPERIORITY||Difference in percentage|-9.17|STANDARD_ERROR_OF_MEAN|4.67||0.0568|TWO_SIDED|90.0|-16.85|-1.482|||Chi-squared|||Week 8||-1.482|-16.85|0.0568
91536986|NCT00383188|182953543|SUPERIORITY||Difference in percentage|4.05|STANDARD_ERROR_OF_MEAN|5.95||0.4961|TWO_SIDED|90.0|-5.727|13.835|||Chi-squared|||Week 8||13.835|-5.727|0.4961
91536987|NCT00383188|182953543|SUPERIORITY||Difference in percentage|6.94|STANDARD_ERROR_OF_MEAN|7.26||0.3212|TWO_SIDED|90.0|-5.008|18.89|||Chi-squared|||Week 8||18.890|-5.008|0.3212
91536988|NCT00383188|182953543|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|6.9||0.8274|TWO_SIDED|90.0|-9.87|12.843|||Chi-squared|||Week 8||12.843|-9.870|0.8274
91536989|NCT00383188|182953543|SUPERIORITY||Difference in percentage|5.23|STANDARD_ERROR_OF_MEAN|5.94||0.3774|TWO_SIDED|90.0|-4.538|14.996|||Chi-squared|||Week 12||14.996|-4.538|0.3774
91536990|NCT00383188|182953543|SUPERIORITY||Difference in percentage|9.46|STANDARD_ERROR_OF_MEAN|6.11||0.1246|TWO_SIDED|90.0|-0.591|19.51|||Chi-squared|||Week 12||19.510|-0.591|0.1246
91536991|NCT00383188|182953543|SUPERIORITY||Difference in percentage|8.29|STANDARD_ERROR_OF_MEAN|7.17||0.2257|TWO_SIDED|90.0|-3.502|20.087|||Chi-squared|||Week 12||20.087|-3.502|0.2257
91536992|NCT00383188|182953543|SUPERIORITY||Difference in percentage|5.34|STANDARD_ERROR_OF_MEAN|7.11||0.4336|TWO_SIDED|90.0|-6.355|17.03|||Chi-squared|||Week 12||17.030|-6.355|0.4336
91536993|NCT00383188|182953543|SUPERIORITY||Difference in percentage|-2.07|STANDARD_ERROR_OF_MEAN|7.02||0.7682|TWO_SIDED|90.0|-13.61|9.467|||Chi-squared|||Week 16||9.467|-13.61|0.7682
91536994|NCT00383188|182953543|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|6.76||0.6726|TWO_SIDED|90.0|-13.97|8.257|||Chi-squared|||Week 16||8.257|-13.97|0.6726
91536995|NCT00383188|182953543|SUPERIORITY||Difference in percentage|-5.64|STANDARD_ERROR_OF_MEAN|7.68||0.4795|TWO_SIDED|90.0|-18.28|7.0|||Chi-squared|||Week 16||7.000|-18.28|0.4795
91536996|NCT00383188|182953543|SUPERIORITY||Difference in percentage|-16.17|STANDARD_ERROR_OF_MEAN|6.1||0.0276|TWO_SIDED|90.0|-26.19|-6.137|||Chi-squared|||Week 16||-6.137|-26.19|0.0276
91536997|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
91536998|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
91536999|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
91537000|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
91537001|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
91537002|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
91537003|NCT00383188|182953544|SUPERIORITY||Difference in percentage|2.27|STANDARD_ERROR_OF_MEAN|2.25||0.1928|TWO_SIDED|90.0|-1.423|5.968|||Chi-squared|||Week 2||5.968|-1.423|0.1928
91537004|NCT00383188|182953544|SUPERIORITY||Difference in percentage|2.5|STANDARD_ERROR_OF_MEAN|2.47||0.1719|TWO_SIDED|90.0|-1.56|6.56|||Chi-squared|||Week 2||6.560|-1.560|0.1719
91537005|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.1|STANDARD_ERROR_OF_MEAN|1.97||0.9603|TWO_SIDED|90.0|-3.138|3.334|||Chi-squared|||Week 4||3.334|-3.138|0.9603
91537006|NCT00383188|182953544|SUPERIORITY||Difference in percentage|-1.35|STANDARD_ERROR_OF_MEAN|1.34||0.3157|TWO_SIDED|90.0|-3.559|0.856|||Chi-squared|||Week 4||0.856|-3.559|0.3157
91537007|NCT00383188|182953544|SUPERIORITY||Difference in percentage|5.47|STANDARD_ERROR_OF_MEAN|4.03||0.1125|TWO_SIDED|90.0|-1.162|12.096|||Chi-squared|||Week 4||12.096|-1.162|0.1125
91537008|NCT00383188|182953544|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|3.7||0.2455|TWO_SIDED|90.0|-2.434|9.732|||Chi-squared|||Week 4||9.732|-2.434|0.2455
91537009|NCT00383188|182953544|SUPERIORITY||Difference in percentage|-2.6|STANDARD_ERROR_OF_MEAN|2.71||0.3452|TWO_SIDED|90.0|-7.057|1.847|||Chi-squared|||Week 8||1.847|-7.057|0.3452
91537010|NCT00383188|182953544|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|3.24||1|TWO_SIDED|90.0|-5.333|5.333|||Chi-squared|||Week 8||5.333|-5.333|1.0000
91537011|NCT00383188|182953544|SUPERIORITY||Difference in percentage|7.31|STANDARD_ERROR_OF_MEAN|5.31||0.1267|TWO_SIDED|90.0|-1.417|16.036|||Chi-squared|||Week 8||16.036|-1.417|0.1267
91537012|NCT00383188|182953544|SUPERIORITY||Difference in percentage|5.95|STANDARD_ERROR_OF_MEAN|5.27||0.2069|TWO_SIDED|90.0|-2.72|14.612|||Chi-squared|||Week 8||14.612|-2.720|0.2069
91537013|NCT00383188|182953544|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.08||0.6506|TWO_SIDED|90.0|-4.871|8.553|||Chi-squared|||Week 12||8.553|-4.871|0.6506
91537014|NCT00383188|182953544|SUPERIORITY||Difference in percentage|2.7|STANDARD_ERROR_OF_MEAN|4.12||0.5125|TWO_SIDED|90.0|-4.075|9.48|||Chi-squared|||Week 12||9.480|-4.075|0.5125
91762955|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||<0.0001
91537015|NCT00383188|182953544|SUPERIORITY||Difference in percentage|3.69|STANDARD_ERROR_OF_MEAN|5.07||0.4412|TWO_SIDED|90.0|-4.652|12.023|||Chi-squared|||Week 12||12.023|-4.652|0.4412
91537016|NCT00383188|182953544|SUPERIORITY||Difference in percentage|2.09|STANDARD_ERROR_OF_MEAN|4.92||0.6566|TWO_SIDED|90.0|-6.006|10.195|||Chi-squared|||Week 12||10.195|-6.006|0.6566
91537017|NCT00383188|182953544|SUPERIORITY||Difference in percentage|-5.16|STANDARD_ERROR_OF_MEAN|4.5||0.2634|TWO_SIDED|90.0|-12.57|2.247|||Chi-squared|||Week 16||2.247|-12.57|0.2634
91537018|NCT00383188|182953544|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|4.73||0.546|TWO_SIDED|90.0|-10.63|4.916|||Chi-squared|||Week 16||4.916|-10.63|0.5460
91537019|NCT00383188|182953544|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
91537020|NCT00383188|182953544|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
91537021|NCT00383188|182953545|SUPERIORITY||Least Square Mean (LSM) Difference|-0.388|STANDARD_ERROR_OF_MEAN|1.025||0.7053|TWO_SIDED|95.0|-2.4|1.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.624|-2.400|0.7053
91537022|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.312|STANDARD_ERROR_OF_MEAN|1.009||0.1938|TWO_SIDED|95.0|-3.291|0.668|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.668|-3.291|0.1938
91537023|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.187|STANDARD_ERROR_OF_MEAN|1.174||0.0627|TWO_SIDED|95.0|-4.491|0.116|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.116|-4.491|0.0627
91537024|NCT00383188|182953545|SUPERIORITY||LSM Difference|-0.851|STANDARD_ERROR_OF_MEAN|1.206||0.4809|TWO_SIDED|95.0|-3.218|1.517|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.517|-3.218|0.4809
91537025|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.289|STANDARD_ERROR_OF_MEAN|1.017||0.2057|TWO_SIDED|95.0|-3.286|0.709|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.709|-3.286|0.2057
91537026|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.331|STANDARD_ERROR_OF_MEAN|0.999||0.1833|TWO_SIDED|95.0|-3.293|0.631|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.631|-3.293|0.1833
91537027|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.748|STANDARD_ERROR_OF_MEAN|1.166||0.0187|TWO_SIDED|95.0|-5.037|-0.459|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.459|-5.037|0.0187
91537028|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.345|STANDARD_ERROR_OF_MEAN|1.197||0.2615|TWO_SIDED|95.0|-3.695|1.005|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.005|-3.695|0.2615
91537029|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.764|STANDARD_ERROR_OF_MEAN|1.017||0.0832|TWO_SIDED|95.0|-3.761|0.233|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.233|-3.761|0.0832
91537030|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.615|STANDARD_ERROR_OF_MEAN|0.999||0.1066|TWO_SIDED|95.0|-3.576|0.347|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.347|-3.576|0.1066
91537031|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.406|STANDARD_ERROR_OF_MEAN|1.166||0.0394|TWO_SIDED|95.0|-4.695|-0.118|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.118|-4.695|0.0394
91537032|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.355|STANDARD_ERROR_OF_MEAN|1.197||0.258|TWO_SIDED|95.0|-3.705|0.995|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.995|-3.705|0.2580
91537033|NCT00383188|182953545|SUPERIORITY||LSM Difference|-0.758|STANDARD_ERROR_OF_MEAN|1.017||0.456|TWO_SIDED|95.0|-2.754|1.238|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.238|-2.754|0.4560
91762956|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0019
91762957|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0781
91762958|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||<0.0001
91537034|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.021|STANDARD_ERROR_OF_MEAN|0.999||0.0434|TWO_SIDED|95.0|-3.982|-0.06|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.060|-3.982|0.0434
91537035|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.728|STANDARD_ERROR_OF_MEAN|1.165||0.1386|TWO_SIDED|95.0|-4.016|0.56|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.560|-4.016|0.1386
91537036|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.154|STANDARD_ERROR_OF_MEAN|1.197||0.3353|TWO_SIDED|95.0|-3.503|1.196|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.196|-3.503|0.3353
91537037|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.016||0.041|TWO_SIDED|95.0|-4.075|-0.085|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.085|-4.075|0.0410
91537038|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.234|STANDARD_ERROR_OF_MEAN|0.998||0.0255|TWO_SIDED|95.0|-4.194|-0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.274|-4.194|0.0255
91537039|NCT00383188|182953545|SUPERIORITY||LSM Difference|-2.384|STANDARD_ERROR_OF_MEAN|1.165||0.041|TWO_SIDED|95.0|-4.671|-0.097|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.097|-4.671|0.0410
91537040|NCT00383188|182953545|SUPERIORITY||LSM Difference|-1.911|STANDARD_ERROR_OF_MEAN|1.196||0.1106|TWO_SIDED|95.0|-4.259|0.438|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.438|-4.259|0.1106
91537041|NCT00383188|182953545|SUPERIORITY||LSM Difference|-0.251|STANDARD_ERROR_OF_MEAN|1.048||0.8107|TWO_SIDED|95.0|-2.307|1.805|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.805|-2.307|0.8107
91537042|NCT00383188|182953545|SUPERIORITY||LSM Difference|0.272|STANDARD_ERROR_OF_MEAN|1.017||0.7895|TWO_SIDED|95.0|-1.726|2.269|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.269|-1.726|0.7895
91537043|NCT00383188|182953545|SUPERIORITY||LSM Difference|-0.306|STANDARD_ERROR_OF_MEAN|1.206||0.7996|TWO_SIDED|95.0|-2.673|2.06|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.060|-2.673|0.7996
91537044|NCT00383188|182953545|SUPERIORITY||LSM Difference|0.185|STANDARD_ERROR_OF_MEAN|1.235||0.8811|TWO_SIDED|95.0|-2.24|2.61|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.610|-2.240|0.8811
91537045|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.687|STANDARD_ERROR_OF_MEAN|0.886||0.4385|TWO_SIDED|95.0|-2.427|1.053|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.053|-2.427|0.4385
91537046|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.085|STANDARD_ERROR_OF_MEAN|0.87||0.2131|TWO_SIDED|95.0|-2.794|0.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.624|-2.794|0.2131
91537047|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.013||0.1216|TWO_SIDED|95.0|-3.559|0.419|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.419|-3.559|0.1216
91537048|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.675|STANDARD_ERROR_OF_MEAN|1.046||0.519|TWO_SIDED|95.0|-2.728|1.378|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.378|-2.728|0.5190
91537049|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.464|STANDARD_ERROR_OF_MEAN|0.88||0.0967|TWO_SIDED|95.0|-3.193|0.264|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.264|-3.193|0.0967
91537050|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.027|STANDARD_ERROR_OF_MEAN|0.863||0.2346|TWO_SIDED|95.0|-2.721|0.668|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.668|-2.721|0.2346
91537051|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.658|STANDARD_ERROR_OF_MEAN|1.007||0.1|TWO_SIDED|95.0|-3.635|0.318|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.318|-3.635|0.1000
91537052|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.805|STANDARD_ERROR_OF_MEAN|1.038||0.4385|TWO_SIDED|95.0|-2.844|1.234|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.234|-2.844|0.4385
91537053|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.599|STANDARD_ERROR_OF_MEAN|0.88||0.0696|TWO_SIDED|95.0|-3.327|0.128|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.128|-3.327|0.0696
91537054|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.863||0.0642|TWO_SIDED|95.0|-3.294|0.094|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.094|-3.294|0.0642
91537055|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.83|STANDARD_ERROR_OF_MEAN|1.007||0.0695|TWO_SIDED|95.0|-3.807|0.146|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.146|-3.807|0.0695
91537056|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.493|STANDARD_ERROR_OF_MEAN|1.038||0.6349|TWO_SIDED|95.0|-2.532|1.545|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.545|-2.532|0.6349
91537057|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.176|STANDARD_ERROR_OF_MEAN|0.88||0.1818|TWO_SIDED|95.0|-2.903|0.551|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.551|-2.903|0.1818
91537058|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.268|STANDARD_ERROR_OF_MEAN|0.862||0.1421|TWO_SIDED|95.0|-2.961|0.426|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.426|-2.961|0.1421
91537059|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.898|STANDARD_ERROR_OF_MEAN|1.006||0.3726|TWO_SIDED|95.0|-2.874|1.078|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.078|-2.874|0.3726
91537060|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.701|STANDARD_ERROR_OF_MEAN|1.038||0.4995|TWO_SIDED|95.0|-2.739|1.337|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.337|-2.739|0.4995
91537061|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.601|STANDARD_ERROR_OF_MEAN|0.879||0.0691|TWO_SIDED|95.0|-3.327|0.126|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.126|-3.327|0.0691
91537062|NCT00383188|182953546|SUPERIORITY||LSM Difference|-1.086|STANDARD_ERROR_OF_MEAN|0.862||0.2083|TWO_SIDED|95.0|-2.778|0.607|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.607|-2.778|0.2083
91537063|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.836|STANDARD_ERROR_OF_MEAN|1.006||0.4063|TWO_SIDED|95.0|-2.811|1.139|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.139|-2.811|0.4063
91537064|NCT00383188|182953546|SUPERIORITY||LSM Difference|-0.196|STANDARD_ERROR_OF_MEAN|1.038||0.8501|TWO_SIDED|95.0|-2.234|1.841|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.841|-2.234|0.8501
91537065|NCT00383188|182953546|SUPERIORITY||LSM Difference|0.376|STANDARD_ERROR_OF_MEAN|0.904||0.6778|TWO_SIDED|95.0|-1.399|2.15|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.150|-1.399|0.6778
91537066|NCT00383188|182953546|SUPERIORITY||LSM Difference|0.508|STANDARD_ERROR_OF_MEAN|0.877||0.5627|TWO_SIDED|95.0|-1.214|2.23|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.230|-1.214|0.5627
91537067|NCT00383188|182953546|SUPERIORITY||LSM Difference|0.537|STANDARD_ERROR_OF_MEAN|1.038||0.6049|TWO_SIDED|95.0|-1.501|2.576|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.576|-1.501|0.6049
91537068|NCT00383188|182953546|SUPERIORITY||LSM Difference|0.51|STANDARD_ERROR_OF_MEAN|1.068||0.6332|TWO_SIDED|95.0|-1.587|2.608|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.608|-1.587|0.6332
91537069|NCT00383188|182953547|SUPERIORITY||LSM Difference|-2.802|STANDARD_ERROR_OF_MEAN|4.098||0.4943|TWO_SIDED|95.0|-10.85|5.243|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.243|-10.85|0.4943
91537070|NCT00383188|182953547|SUPERIORITY||LSM Difference|-10.19|STANDARD_ERROR_OF_MEAN|4.026||0.0116|TWO_SIDED|95.0|-18.09|-2.283|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.283|-18.09|0.0116
91537071|NCT00383188|182953547|SUPERIORITY||LSM Difference|-12.73|STANDARD_ERROR_OF_MEAN|4.71||0.007|TWO_SIDED|95.0|-21.98|-3.485|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.485|-21.98|0.0070
91537072|NCT00383188|182953547|SUPERIORITY||LSM Difference|-11.14|STANDARD_ERROR_OF_MEAN|4.812||0.0209|TWO_SIDED|95.0|-20.58|-1.688|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-1.688|-20.58|0.0209
91537073|NCT00383188|182953547|SUPERIORITY||LSM Difference|-7.439|STANDARD_ERROR_OF_MEAN|4.056||0.0671|TWO_SIDED|95.0|-15.4|0.524|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.524|-15.40|0.0671
91537074|NCT00383188|182953547|SUPERIORITY||LSM Difference|-10.46|STANDARD_ERROR_OF_MEAN|3.986||0.0089|TWO_SIDED|95.0|-18.28|-2.632|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.632|-18.28|0.0089
91537075|NCT00383188|182953547|SUPERIORITY||LSM Difference|-14.1|STANDARD_ERROR_OF_MEAN|4.657||0.0025|TWO_SIDED|95.0|-23.24|-4.959|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-4.959|-23.24|0.0025
91537076|NCT00383188|182953547|SUPERIORITY||LSM Difference|-7.876|STANDARD_ERROR_OF_MEAN|4.774||0.0994|TWO_SIDED|95.0|-17.25|1.496|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.496|-17.25|0.0994
91537077|NCT00383188|182953547|SUPERIORITY||LSM Difference|-1.964|STANDARD_ERROR_OF_MEAN|4.056||0.6284|TWO_SIDED|95.0|-9.926|5.999|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.999|-9.926|0.6284
91537078|NCT00383188|182953547|SUPERIORITY||LSM Difference|-9.934|STANDARD_ERROR_OF_MEAN|3.986||0.0129|TWO_SIDED|95.0|-17.76|-2.109|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.109|-17.76|0.0129
91537079|NCT00383188|182953547|SUPERIORITY||LSM Difference|-8.097|STANDARD_ERROR_OF_MEAN|4.656||0.0825|TWO_SIDED|95.0|-17.24|1.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.044|-17.24|0.0825
91537080|NCT00383188|182953547|SUPERIORITY||LSM Difference|-1.907|STANDARD_ERROR_OF_MEAN|4.774||0.6897|TWO_SIDED|95.0|-11.28|7.465|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||7.465|-11.28|0.6897
91537081|NCT00383188|182953547|SUPERIORITY||LSM Difference|1.861|STANDARD_ERROR_OF_MEAN|4.055||0.6465|TWO_SIDED|95.0|-6.1|9.821|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||9.821|-6.100|0.6465
91537082|NCT00383188|182953547|SUPERIORITY||LSM Difference|-10.65|STANDARD_ERROR_OF_MEAN|3.985||0.0077|TWO_SIDED|95.0|-18.47|-2.824|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.824|-18.47|0.0077
91537083|NCT00383188|182953547|SUPERIORITY||LSM Difference|-7.927|STANDARD_ERROR_OF_MEAN|4.655||0.089|TWO_SIDED|95.0|-17.07|1.213|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.213|-17.07|0.0890
91537084|NCT00383188|182953547|SUPERIORITY||LSM Difference|-5.964|STANDARD_ERROR_OF_MEAN|4.773||0.2119|TWO_SIDED|95.0|-15.33|3.406|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.406|-15.33|0.2119
91537085|NCT00383188|182953547|SUPERIORITY||LSM Difference|-4.766|STANDARD_ERROR_OF_MEAN|4.053||0.2401|TWO_SIDED|95.0|-12.72|3.191|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.191|-12.72|0.2401
91762959|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.0001
91537086|NCT00383188|182953547|SUPERIORITY||LSM Difference|-11.07|STANDARD_ERROR_OF_MEAN|3.983||0.0056|TWO_SIDED|95.0|-18.89|-3.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.251|-18.89|0.0056
91537087|NCT00383188|182953547|SUPERIORITY||LSM Difference|-8.885|STANDARD_ERROR_OF_MEAN|4.654||0.0566|TWO_SIDED|95.0|-18.02|0.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.251|-18.02|0.0566
91537088|NCT00383188|182953547|SUPERIORITY||LSM Difference|-10.09|STANDARD_ERROR_OF_MEAN|4.772||0.0348|TWO_SIDED|95.0|-19.45|-0.72|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-0.720|-19.45|0.0348
91537089|NCT00383188|182953547|SUPERIORITY||LSM Difference|4.89|STANDARD_ERROR_OF_MEAN|4.191||0.2436|TWO_SIDED|95.0|-3.336|13.116|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.116|-3.336|0.2436
91537090|NCT00383188|182953547|SUPERIORITY||LSM Difference|-1.781|STANDARD_ERROR_OF_MEAN|4.066||0.6616|TWO_SIDED|95.0|-9.762|6.201|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||6.201|-9.762|0.6616
91537091|NCT00383188|182953547|SUPERIORITY||LSM Difference|3.907|STANDARD_ERROR_OF_MEAN|4.83||0.4189|TWO_SIDED|95.0|-5.574|13.388|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.388|-5.574|0.4189
91537092|NCT00383188|182953547|SUPERIORITY||LSM Difference|4.395|STANDARD_ERROR_OF_MEAN|4.942||0.3741|TWO_SIDED|95.0|-5.305|14.096|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||14.096|-5.305|0.3741
91537093|NCT00383188|182953548|SUPERIORITY||LSM Difference|-2.996|STANDARD_ERROR_OF_MEAN|3.958||0.4493|TWO_SIDED|95.0|-10.77|4.773|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.773|-10.77|0.4493
91537094|NCT00383188|182953548|SUPERIORITY||LSM Difference|-14.45|STANDARD_ERROR_OF_MEAN|3.891||0.0002|TWO_SIDED|95.0|-22.08|-6.807|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-6.807|-22.08|0.0002
91537095|NCT00383188|182953548|SUPERIORITY||LSM Difference|-11.54|STANDARD_ERROR_OF_MEAN|4.522||0.0109|TWO_SIDED|95.0|-20.42|-2.661|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.661|-20.42|0.0109
91537096|NCT00383188|182953548|SUPERIORITY||LSM Difference|-7.364|STANDARD_ERROR_OF_MEAN|4.651||0.1137|TWO_SIDED|95.0|-16.49|1.765|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.765|-16.49|0.1137
91537097|NCT00383188|182953548|SUPERIORITY||LSM Difference|-3.989|STANDARD_ERROR_OF_MEAN|3.915||0.3086|TWO_SIDED|95.0|-11.68|3.697|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.697|-11.68|0.3086
91537098|NCT00383188|182953548|SUPERIORITY||LSM Difference|-8.357|STANDARD_ERROR_OF_MEAN|3.85||0.0303|TWO_SIDED|95.0|-15.92|-0.799|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.799|-15.92|0.0303
91537099|NCT00383188|182953548|SUPERIORITY||LSM Difference|-10.66|STANDARD_ERROR_OF_MEAN|4.489||0.0178|TWO_SIDED|95.0|-19.47|-1.845|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.845|-19.47|0.0178
91537100|NCT00383188|182953548|SUPERIORITY||LSM Difference|-5.325|STANDARD_ERROR_OF_MEAN|4.612||0.2486|TWO_SIDED|95.0|-14.38|3.729|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.729|-14.38|0.2486
91537101|NCT00383188|182953548|SUPERIORITY||LSM Difference|-2.965|STANDARD_ERROR_OF_MEAN|3.915||0.4491|TWO_SIDED|95.0|-10.65|4.72|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.720|-10.65|0.4491
91537102|NCT00383188|182953548|SUPERIORITY||LSM Difference|-10.23|STANDARD_ERROR_OF_MEAN|3.85||0.0081|TWO_SIDED|95.0|-17.79|-2.671|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.671|-17.79|0.0081
91537103|NCT00383188|182953548|SUPERIORITY||LSM Difference|-9.291|STANDARD_ERROR_OF_MEAN|4.488||0.0388|TWO_SIDED|95.0|-18.1|-0.48|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.480|-18.10|0.0388
91537104|NCT00383188|182953548|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.611||0.588|TWO_SIDED|95.0|-11.55|6.553|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.553|-11.55|0.5880
91537105|NCT00383188|182953548|SUPERIORITY||LSM Difference|3.78|STANDARD_ERROR_OF_MEAN|3.914||0.3345|TWO_SIDED|95.0|-3.904|11.464|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||11.464|-3.904|0.3345
91537106|NCT00383188|182953548|SUPERIORITY||LSM Difference|-9.019|STANDARD_ERROR_OF_MEAN|3.849||0.0194|TWO_SIDED|95.0|-16.58|-1.463|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.463|-16.58|0.0194
91537107|NCT00383188|182953548|SUPERIORITY||LSM Difference|-5.946|STANDARD_ERROR_OF_MEAN|4.488||0.1855|TWO_SIDED|95.0|-14.76|2.863|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.863|-14.76|0.1855
91537108|NCT00383188|182953548|SUPERIORITY||LSM Difference|-5.249|STANDARD_ERROR_OF_MEAN|4.611||0.2553|TWO_SIDED|95.0|-14.3|3.803|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.803|-14.30|0.2553
91537109|NCT00383188|182953548|SUPERIORITY||LSM Difference|-4.041|STANDARD_ERROR_OF_MEAN|3.912||0.302|TWO_SIDED|95.0|-11.72|3.639|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.639|-11.72|0.3020
91537110|NCT00383188|182953548|SUPERIORITY||LSM Difference|-10.27|STANDARD_ERROR_OF_MEAN|3.847||0.0078|TWO_SIDED|95.0|-17.82|-2.715|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.715|-17.82|0.0078
91537111|NCT00383188|182953548|SUPERIORITY||LSM Difference|-8.522|STANDARD_ERROR_OF_MEAN|4.486||0.0578|TWO_SIDED|95.0|-17.33|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.284|-17.33|0.0578
91537112|NCT00383188|182953548|SUPERIORITY||LSM Difference|-7.042|STANDARD_ERROR_OF_MEAN|4.61||0.127|TWO_SIDED|95.0|-16.09|2.007|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.007|-16.09|0.1270
91537113|NCT00383188|182953548|SUPERIORITY||LSM Difference|5.927|STANDARD_ERROR_OF_MEAN|4.051||0.1438|TWO_SIDED|95.0|-2.023|13.877|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||13.877|-2.023|0.1438
91537114|NCT00383188|182953548|SUPERIORITY||LSM Difference|-1.979|STANDARD_ERROR_OF_MEAN|3.931||0.6149|TWO_SIDED|95.0|-9.696|5.738|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.738|-9.696|0.6149
91537115|NCT00383188|182953548|SUPERIORITY||LSM Difference|6.545|STANDARD_ERROR_OF_MEAN|4.664||0.1609|TWO_SIDED|95.0|-2.61|15.7|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.700|-2.610|0.1609
91537116|NCT00383188|182953548|SUPERIORITY||LSM Difference|6.579|STANDARD_ERROR_OF_MEAN|4.78||0.1691|TWO_SIDED|95.0|-2.804|15.961|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.961|-2.804|0.1691
91537117|NCT00383188|182953549|SUPERIORITY||LSM Difference|-1.409|STANDARD_ERROR_OF_MEAN|3.341||0.6733|TWO_SIDED|95.0|-7.967|5.149|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.149|-7.967|0.6733
91537118|NCT00383188|182953549|SUPERIORITY||LSM Difference|-5.629|STANDARD_ERROR_OF_MEAN|3.274||0.0859|TWO_SIDED|95.0|-12.05|0.797|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.797|-12.05|0.0859
91537119|NCT00383188|182953549|SUPERIORITY||LSM Difference|-9.718|STANDARD_ERROR_OF_MEAN|3.8||0.0107|TWO_SIDED|95.0|-17.18|-2.259|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.259|-17.18|0.0107
91537120|NCT00383188|182953549|SUPERIORITY||LSM Difference|-3.695|STANDARD_ERROR_OF_MEAN|3.921||0.3463|TWO_SIDED|95.0|-11.39|4.002|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.002|-11.39|0.3463
91537121|NCT00383188|182953549|SUPERIORITY||LSM Difference|-5.185|STANDARD_ERROR_OF_MEAN|3.312||0.1178|TWO_SIDED|95.0|-11.69|1.316|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.316|-11.69|0.1178
91537122|NCT00383188|182953549|SUPERIORITY||LSM Difference|-7.107|STANDARD_ERROR_OF_MEAN|3.245||0.0288|TWO_SIDED|95.0|-13.48|-0.737|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.737|-13.48|0.0288
91537123|NCT00383188|182953549|SUPERIORITY||LSM Difference|-9.743|STANDARD_ERROR_OF_MEAN|3.772||0.01|TWO_SIDED|95.0|-17.15|-2.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.340|-17.15|0.0100
91537124|NCT00383188|182953549|SUPERIORITY||LSM Difference|-5.468|STANDARD_ERROR_OF_MEAN|3.888||0.16|TWO_SIDED|95.0|-13.1|2.164|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.164|-13.10|0.1600
91537125|NCT00383188|182953549|SUPERIORITY||LSM Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.312||0.904|TWO_SIDED|95.0|-6.9|6.101|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.101|-6.900|0.9040
91537126|NCT00383188|182953549|SUPERIORITY||LSM Difference|-6.895|STANDARD_ERROR_OF_MEAN|3.245||0.0339|TWO_SIDED|95.0|-13.26|-0.524|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.524|-13.26|0.0339
91537127|NCT00383188|182953549|SUPERIORITY||LSM Difference|-8.891|STANDARD_ERROR_OF_MEAN|3.771||0.0186|TWO_SIDED|95.0|-16.29|-1.488|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.488|-16.29|0.0186
91537128|NCT00383188|182953549|SUPERIORITY||LSM Difference|-2.714|STANDARD_ERROR_OF_MEAN|3.888||0.4854|TWO_SIDED|95.0|-10.35|4.918|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.918|-10.35|0.4854
91537129|NCT00383188|182953549|SUPERIORITY||LSM Difference|-1.387|STANDARD_ERROR_OF_MEAN|3.311||0.6753|TWO_SIDED|95.0|-7.886|5.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.112|-7.886|0.6753
91537130|NCT00383188|182953549|SUPERIORITY||LSM Difference|-11.09|STANDARD_ERROR_OF_MEAN|3.244||0.0007|TWO_SIDED|95.0|-17.46|-4.724|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-4.724|-17.46|0.0007
91537131|NCT00383188|182953549|SUPERIORITY||LSM Difference|-9.535|STANDARD_ERROR_OF_MEAN|3.771||0.0116|TWO_SIDED|95.0|-16.94|-2.134|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.134|-16.94|0.0116
91537132|NCT00383188|182953549|SUPERIORITY||LSM Difference|-8.322|STANDARD_ERROR_OF_MEAN|3.888||0.0326|TWO_SIDED|95.0|-15.95|-0.691|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.691|-15.95|0.0326
91537133|NCT00383188|182953549|SUPERIORITY||LSM Difference|-3.624|STANDARD_ERROR_OF_MEAN|3.309||0.2738|TWO_SIDED|95.0|-10.12|2.872|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.872|-10.12|0.2738
91537134|NCT00383188|182953549|SUPERIORITY||LSM Difference|-9.778|STANDARD_ERROR_OF_MEAN|3.243||0.0026|TWO_SIDED|95.0|-16.14|-3.412|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-3.412|-16.14|0.0026
91537135|NCT00383188|182953549|SUPERIORITY||LSM Difference|-9.339|STANDARD_ERROR_OF_MEAN|3.769||0.0134|TWO_SIDED|95.0|-16.74|-1.941|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.941|-16.74|0.0134
91537136|NCT00383188|182953549|SUPERIORITY||LSM Difference|-5.528|STANDARD_ERROR_OF_MEAN|3.886||0.1553|TWO_SIDED|95.0|-13.16|2.101|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.101|-13.16|0.1553
91537137|NCT00383188|182953549|SUPERIORITY||LSM Difference|-0.118|STANDARD_ERROR_OF_MEAN|3.444||0.9726|TWO_SIDED|95.0|-6.878|6.641|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.641|-6.878|0.9726
91537138|NCT00383188|182953549|SUPERIORITY||LSM Difference|1.409|STANDARD_ERROR_OF_MEAN|3.321||0.6714|TWO_SIDED|95.0|-5.109|7.928|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||7.928|-5.109|0.6714
91537139|NCT00383188|182953549|SUPERIORITY||LSM Difference|0.646|STANDARD_ERROR_OF_MEAN|3.925||0.8693|TWO_SIDED|95.0|-7.058|8.351|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||8.351|-7.058|0.8693
91537140|NCT00383188|182953549|SUPERIORITY||LSM Difference|1.289|STANDARD_ERROR_OF_MEAN|4.035||0.7495|TWO_SIDED|95.0|-6.631|9.208|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||9.208|-6.631|0.7495
91537141|NCT00383188|182953550|SUPERIORITY||LSM Difference|-8.983|STANDARD_ERROR_OF_MEAN|4.469||0.0447|TWO_SIDED|95.0|-17.75|-0.214|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-0.214|-17.75|0.0447
91537142|NCT00383188|182953550|SUPERIORITY||LSM Difference|-15.12|STANDARD_ERROR_OF_MEAN|4.345||0.0005|TWO_SIDED|95.0|-23.65|-6.596|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.596|-23.65|0.0005
91537143|NCT00383188|182953550|SUPERIORITY||LSM Difference|-17.07|STANDARD_ERROR_OF_MEAN|4.981||0.0006|TWO_SIDED|95.0|-26.84|-7.296|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-7.296|-26.84|0.0006
91537144|NCT00383188|182953550|SUPERIORITY||LSM Difference|-16.26|STANDARD_ERROR_OF_MEAN|5.218||0.0019|TWO_SIDED|95.0|-26.49|-6.018|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.018|-26.49|0.0019
91537145|NCT00383188|182953550|SUPERIORITY||LSM Difference|-3.841|STANDARD_ERROR_OF_MEAN|4.366||0.3792|TWO_SIDED|95.0|-12.41|4.726|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.726|-12.41|0.3792
91537146|NCT00383188|182953550|SUPERIORITY||LSM Difference|-9.345|STANDARD_ERROR_OF_MEAN|4.237||0.0276|TWO_SIDED|95.0|-17.66|-1.031|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-1.031|-17.66|0.0276
91537147|NCT00383188|182953550|SUPERIORITY||LSM Difference|-12.69|STANDARD_ERROR_OF_MEAN|4.873||0.0093|TWO_SIDED|95.0|-22.25|-3.128|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-3.128|-22.25|0.0093
91537148|NCT00383188|182953550|SUPERIORITY||LSM Difference|-9.599|STANDARD_ERROR_OF_MEAN|5.03||0.0566|TWO_SIDED|95.0|-19.47|0.271|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||0.271|-19.47|0.0566
91537149|NCT00383188|182953550|SUPERIORITY||LSM Difference|0.803|STANDARD_ERROR_OF_MEAN|4.366||0.854|TWO_SIDED|95.0|-7.764|9.37|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||9.370|-7.764|0.8540
91537150|NCT00383188|182953550|SUPERIORITY||LSM Difference|-2.364|STANDARD_ERROR_OF_MEAN|4.237||0.577|TWO_SIDED|95.0|-10.68|5.95|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||5.950|-10.68|0.5770
91537151|NCT00383188|182953550|SUPERIORITY||LSM Difference|-6.33|STANDARD_ERROR_OF_MEAN|4.873||0.1942|TWO_SIDED|95.0|-15.89|3.232|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||3.232|-15.89|0.1942
91537152|NCT00383188|182953550|SUPERIORITY||LSM Difference|1.494|STANDARD_ERROR_OF_MEAN|5.03||0.7665|TWO_SIDED|95.0|-8.376|11.364|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.364|-8.376|0.7665
91537153|NCT00383188|182953550|SUPERIORITY||LSM Difference|3.291|STANDARD_ERROR_OF_MEAN|4.366||0.4512|TWO_SIDED|95.0|-5.276|11.858|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.858|-5.276|0.4512
91537154|NCT00383188|182953550|SUPERIORITY||LSM Difference|-0.095|STANDARD_ERROR_OF_MEAN|4.237||0.9822|TWO_SIDED|95.0|-8.409|8.22|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||8.220|-8.409|0.9822
91537155|NCT00383188|182953550|SUPERIORITY||LSM Difference|-5.148|STANDARD_ERROR_OF_MEAN|4.873||0.291|TWO_SIDED|95.0|-14.71|4.414|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.414|-14.71|0.2910
91537156|NCT00383188|182953550|SUPERIORITY||LSM Difference|2.828|STANDARD_ERROR_OF_MEAN|5.03||0.5741|TWO_SIDED|95.0|-7.042|12.698|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||12.698|-7.042|0.5741
91537157|NCT00383188|182953550|SUPERIORITY||LSM Difference|3.107|STANDARD_ERROR_OF_MEAN|4.366||0.4768|TWO_SIDED|95.0|-5.46|11.674|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.674|-5.460|0.4768
91537158|NCT00383188|182953550|SUPERIORITY||LSM Difference|-2.256|STANDARD_ERROR_OF_MEAN|4.237||0.5945|TWO_SIDED|95.0|-10.57|6.058|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||6.058|-10.57|0.5945
91537159|NCT00383188|182953550|SUPERIORITY||LSM Difference|0.609|STANDARD_ERROR_OF_MEAN|4.873||0.9006|TWO_SIDED|95.0|-8.953|10.171|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||10.171|-8.953|0.9006
91537160|NCT00383188|182953550|SUPERIORITY||LSM Difference|9.224|STANDARD_ERROR_OF_MEAN|5.03||0.067|TWO_SIDED|95.0|-0.646|19.094|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||19.094|-0.646|0.0670
91537161|NCT00383188|182953550|SUPERIORITY||LSM Difference|8.261|STANDARD_ERROR_OF_MEAN|4.647||0.0757|TWO_SIDED|95.0|-0.857|17.379|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||17.379|-0.857|0.0757
91537162|NCT00383188|182953550|SUPERIORITY||LSM Difference|5.357|STANDARD_ERROR_OF_MEAN|4.427||0.2265|TWO_SIDED|95.0|-3.329|14.043|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||14.043|-3.329|0.2265
91537163|NCT00383188|182953550|SUPERIORITY||LSM Difference|1.642|STANDARD_ERROR_OF_MEAN|5.178||0.7512|TWO_SIDED|95.0|-8.517|11.801|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.801|-8.517|0.7512
91537164|NCT00383188|182953550|SUPERIORITY||LSM Difference|2.888|STANDARD_ERROR_OF_MEAN|5.323||0.5876|TWO_SIDED|95.0|-7.557|13.332|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||13.332|-7.557|0.5876
91537165|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.269|STANDARD_ERROR_OF_MEAN|0.188||0.154|TWO_SIDED|95.0|-0.638|0.101|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.101|-0.638|0.1540
91537166|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.182||0.0011|TWO_SIDED|95.0|-0.958|-0.242|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.242|-0.958|0.0011
91537167|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.691|STANDARD_ERROR_OF_MEAN|0.211||0.0011|TWO_SIDED|95.0|-1.105|-0.277|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.277|-1.105|0.0011
91537168|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.554|STANDARD_ERROR_OF_MEAN|0.219||0.0115|TWO_SIDED|95.0|-0.983|-0.125|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.125|-0.983|0.0115
91537169|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.094|TWO_SIDED|95.0|-0.673|0.053|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.053|-0.673|0.0940
91537170|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.459|STANDARD_ERROR_OF_MEAN|0.18||0.0109|TWO_SIDED|95.0|-0.811|-0.106|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.106|-0.811|0.0109
91537171|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.667|STANDARD_ERROR_OF_MEAN|0.208||0.0014|TWO_SIDED|95.0|-1.075|-0.259|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.259|-1.075|0.0014
91537172|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.447|STANDARD_ERROR_OF_MEAN|0.213||0.0364|TWO_SIDED|95.0|-0.867|-0.028|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.028|-0.867|0.0364
91762960|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.1279|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.1279
91537173|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.271|STANDARD_ERROR_OF_MEAN|0.185||0.1436|TWO_SIDED|95.0|-0.634|0.092|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.092|-0.634|0.1436
91537174|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.18||0.0246|TWO_SIDED|95.0|-0.757|-0.052|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.052|-0.757|0.0246
91762961|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||<0.0001
91762962|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0004
91762963|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0807
91762964|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||<0.0001
91762965|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.0002
91762966|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.418|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.4180
91762967|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||<0.0001
91762968|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.0061
91762969|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.1615|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.1615
91762970|NCT00445770|183416310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||<0.0001
91762971|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0130
91762972|NCT00445770|183416310|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0948
91762973|NCT03228212|183416340|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|1.16|9.09|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||9.09|1.16|
91762974|NCT03228212|183416341|NON_INFERIORITY|A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.00621|||TWO_SIDED|95.0|0.01|0.03|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||0.03|0.01|
91762975|NCT03228212|183416342|NON_INFERIORITY|A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|proportion|0.992|||||TWO_SIDED|95.0|0.96|1.0|||Bayesian Methods|Bayesian Methods-Jefferys prior for binomial proportion was used to calculate 95% credible interval.||It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.||1|0.96|
91762976|NCT03228212|183416343|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|-0.0043|STANDARD_DEVIATION|0.0089|||TWO_SIDED|95.0|-0.0237|0.0129|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data|Mean difference calculated as Test - Control|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.0129|-0.0237|
91537175|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.546|STANDARD_ERROR_OF_MEAN|0.208||0.0088|TWO_SIDED|95.0|-0.954|-0.138|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.138|-0.954|0.0088
91537176|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.267|STANDARD_ERROR_OF_MEAN|0.213||0.2121|TWO_SIDED|95.0|-0.686|0.152|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.152|-0.686|0.2121
91762977|NCT03228212|183416344|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|3.69|10.74|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||10.74|3.69|
91762978|NCT03228212|183416345|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|0.36|6.29|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||6.29|0.36|
91762979|NCT01807299|183416364|OTHER||Mean Difference (Final Values)|5.0||||0.05|ONE_SIDED|5.0|||||Chi-squared, Corrected|||||||0.05
91762980|NCT01938040|183416391|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
91762981|NCT02309944|183416403|SUPERIORITY|||||||0.27|TWO_SIDED|95.0|||||Chi-squared|||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.27
91762982|NCT02309944|183416403|SUPERIORITY|||||||0.24|||||||Regression, Logistic|Multivariate Model (adjusted for ascites and previous laparotomy)||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.24
91762983|NCT02848222|183416444|SUPERIORITY|||||||0.02||||||Threshold for significance was p \< 0.05|ANOVA|||||||0.02
91762984|NCT02451943|183416450|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.6945|TWO_SIDED|95.0|0.841|1.303|||Log Rank|Stratified||||1.303|0.841|0.6945
91762985|NCT02451943|183416451|SUPERIORITY||Hazard Ratio (HR)|0.951||||0.7618|TWO_SIDED|95.0|0.69|1.312|||Log Rank|Stratified||||1.312|0.690|0.7618
91762986|NCT02451943|183416452|SUPERIORITY||Hazard Ratio (HR)|1.231||||0.0422|TWO_SIDED|95.0|1.009|1.502|||Log Rank|Stratified||||1.502|1.009|0.0422
91762987|NCT02451943|183416458|SUPERIORITY||Hazard Ratio (HR)|0.616||||0.0934|TWO_SIDED|95.0|0.347|1.093|||Log Rank|Stratified||||1.093|0.347|0.0934
91762988|NCT02451943|183416459|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.3347|TWO_SIDED|95.0|0.892|1.413|||Log Rank|Stratified||||1.413|0.892|0.3347
91762989|NCT03937713|183416462|OTHER|Calculations were approximated by those of a simple two-sample t-test for mean differences in PSQI in response to BBTI||||||0.05|||||||Mixed Models Analysis|||The sample size selected for this preliminary trial was based on the analysis of the PSQI as the primary outcome. Assuming a correlation coefficient of 0.7 between pre-and post-treatment, 21 patients per arm were needed to achieve 80% power at a significance level of 5% in order to detect a clinically significant difference of 3 units in PSQI. To compensate for an anticipated attrition rate of 25%, the recruitment target was set at 52 participants.||||0.05
91762990|NCT02871635|183416467|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|90.0|0.87|1.028|||||BI 695501 as numerator Humira EU as denominator|Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.028|0.870|
91762991|NCT02871635|183416467|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|95.0|0.856|1.044|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.044|0.856|
91762992|NCT02871635|183416468|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|90.0|0.871|1.148|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.148|0.871|
91762993|NCT02871635|183416468|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.848|1.178|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.178|0.848|
91762994|NCT02871635|183416469|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|90.0|0.751|1.078|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.078|0.751|
91762995|NCT02871635|183416469|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.725|1.116|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.116|0.725|
91762996|NCT00412893|183416535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper bound of the 95% CI for the treatment difference was compared to the protocol prespecified non-inferiority margin of 10%. If the upper bound was smaller than 10%, isavuconazole was declared as non-inferior to voriconazole with respect to the primary outcome measure.|Adjusted Treatment Difference|-1.0|||||TWO_SIDED|95.0|-7.759|5.683|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Approximately 255 patients per group were to be enrolled to ensure at least 80% power to demonstrate that the upper bound of the 95% confidence interval (CI) for a treatment difference in favor of the comparator was no larger than 10%.||5.683|-7.759|
91762997|NCT00412893|183416536|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-9.336|12.572|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||12.572|-9.336|
91537177|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.185||0.5975|TWO_SIDED|95.0|-0.461|0.265|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.265|-0.461|0.5975
91537178|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.464|STANDARD_ERROR_OF_MEAN|0.18||0.0099|TWO_SIDED|95.0|-0.817|-0.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.112|-0.817|0.0099
91537179|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.445|STANDARD_ERROR_OF_MEAN|0.208||0.0328|TWO_SIDED|95.0|-0.853|-0.037|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.037|-0.853|0.0328
91537180|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.213||0.3162|TWO_SIDED|95.0|-0.633|0.205|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.205|-0.633|0.3162
91762998|NCT00412893|183416536|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.5|||||TWO_SIDED|95.0|-11.277|10.329|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.329|-11.277|
91762999|NCT00412893|183416536|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.2|||||TWO_SIDED|95.0|-1.993|18.379|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||18.379|-1.993|
91763000|NCT00412893|183416537|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-9.15|6.34|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|||6.340|-9.150|
91763001|NCT00412893|183416539|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.4|||||TWO_SIDED|95.0|-10.64|11.531|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment Comparison||11.531|-10.640|
91763002|NCT00412893|183416539|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-5.8|||||TWO_SIDED|95.0|-17.368|5.802|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||5.802|-17.368|
91763003|NCT00412893|183416539|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.3|||||TWO_SIDED|95.0|-11.116|11.758|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||11.758|-11.116|
91763004|NCT00412893|183416540|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|3.8|||||TWO_SIDED|95.0|-7.429|15.087|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||15.087|-7.429|
91763005|NCT00412893|183416540|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.7|||||TWO_SIDED|95.0|-11.917|10.586|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 Comparison||10.586|-11.917|
91763006|NCT00412893|183416540|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.1|||||TWO_SIDED|95.0|-1.624|19.83|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 Comparison||19.830|-1.624|
91763007|NCT00412893|183416541|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.7|||||TWO_SIDED|95.0|-4.936|16.268|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.268|-4.936|
91763008|NCT00412893|183416541|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.3|||||TWO_SIDED|95.0|-5.338|16.032|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||16.032|-5.338|
91763009|NCT00412893|183416541|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.0|||||TWO_SIDED|95.0|-1.231|19.186|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||19.186|-1.231|
91763010|NCT00412893|183416542|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.0|||||TWO_SIDED|95.0|-6.043|16.026|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.026|-6.043|
91763011|NCT00412893|183416542|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|0.2|||||TWO_SIDED|95.0|-10.873|11.22|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||11.220|-10.873|
91763012|NCT00412893|183416542|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|4.7|||||TWO_SIDED|95.0|-6.533|15.939|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||15.939|-6.533|
91763013|NCT00412893|183416543|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|4.4|||||TWO_SIDED|95.0|-8.429|17.218|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.218|-8.429|
91537181|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.353|STANDARD_ERROR_OF_MEAN|0.185||0.0569|TWO_SIDED|95.0|-0.716|0.01|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.010|-0.716|0.0569
91537182|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.449|STANDARD_ERROR_OF_MEAN|0.18||0.0126|TWO_SIDED|95.0|-0.801|-0.096|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.096|-0.801|0.0126
91537183|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.515|STANDARD_ERROR_OF_MEAN|0.208||0.0135|TWO_SIDED|95.0|-0.923|-0.107|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.107|-0.923|0.0135
91537184|NCT00383188|182953551|SUPERIORITY||LSM Difference|-0.145|STANDARD_ERROR_OF_MEAN|0.213||0.4979|TWO_SIDED|95.0|-0.564|0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.274|-0.564|0.4979
91537185|NCT00383188|182953551|SUPERIORITY||LSM Difference|0.271|STANDARD_ERROR_OF_MEAN|0.195||0.1643|TWO_SIDED|95.0|-0.111|0.653|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.653|-0.111|0.1643
91537186|NCT00383188|182953551|SUPERIORITY||LSM Difference|0.081|STANDARD_ERROR_OF_MEAN|0.185||0.6611|TWO_SIDED|95.0|-0.282|0.445|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.445|-0.282|0.6611
91537187|NCT00383188|182953551|SUPERIORITY||LSM Difference|0.097|STANDARD_ERROR_OF_MEAN|0.219||0.6587|TWO_SIDED|95.0|-0.333|0.526|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.526|-0.333|0.6587
91537188|NCT00383188|182953551|SUPERIORITY||LSM Difference|0.154|STANDARD_ERROR_OF_MEAN|0.223||0.4903|TWO_SIDED|95.0|-0.284|0.592|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.592|-0.284|0.4903
91537189|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.119|STANDARD_ERROR_OF_MEAN|0.09||0.1857|TWO_SIDED|95.0|-0.296|0.057|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.057|-0.296|0.1857
91537190|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.277|STANDARD_ERROR_OF_MEAN|0.089||0.0019|TWO_SIDED|95.0|-0.451|-0.103|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.103|-0.451|0.0019
91537191|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.244|STANDARD_ERROR_OF_MEAN|0.103||0.0178|TWO_SIDED|95.0|-0.446|-0.042|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.042|-0.446|0.0178
91537192|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.106||0.3547|TWO_SIDED|95.0|-0.305|0.11|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.110|-0.305|0.3547
91537193|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.135|STANDARD_ERROR_OF_MEAN|0.089||0.1301|TWO_SIDED|95.0|-0.31|0.04|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.040|-0.310|0.1301
91537194|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0313|TWO_SIDED|95.0|-0.363|-0.017|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.017|-0.363|0.0313
91537195|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
91537196|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.105||0.6318|TWO_SIDED|95.0|-0.256|0.156|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.156|-0.256|0.6318
91537197|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.055|STANDARD_ERROR_OF_MEAN|0.089||0.5388|TWO_SIDED|95.0|-0.23|0.12|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.120|-0.230|0.5388
91537198|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.157|STANDARD_ERROR_OF_MEAN|0.088||0.0755|TWO_SIDED|95.0|-0.329|0.016|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.016|-0.329|0.0755
91537199|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
91537200|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.072|STANDARD_ERROR_OF_MEAN|0.105||0.4948|TWO_SIDED|95.0|-0.277|0.134|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.134|-0.277|0.4948
91537201|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.089||0.5022|TWO_SIDED|95.0|-0.115|0.235|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.235|-0.115|0.5022
91537202|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0307|TWO_SIDED|95.0|-0.363|-0.018|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.018|-0.363|0.0307
91537203|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.102||0.0933|TWO_SIDED|95.0|-0.372|0.029|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.029|-0.372|0.0933
91537204|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.027|STANDARD_ERROR_OF_MEAN|0.105||0.7967|TWO_SIDED|95.0|-0.179|0.233|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.233|-0.179|0.7967
91537205|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.089||0.7059|TWO_SIDED|95.0|-0.208|0.141|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.141|-0.208|0.7059
91537206|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.213|STANDARD_ERROR_OF_MEAN|0.088||0.0154|TWO_SIDED|95.0|-0.386|-0.041|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.041|-0.386|0.0154
91537207|NCT00383188|182953553|SUPERIORITY||LSM Difference|-0.136|STANDARD_ERROR_OF_MEAN|0.102||0.1836|TWO_SIDED|95.0|-0.336|0.065|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.065|-0.336|0.1836
91537208|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.078|STANDARD_ERROR_OF_MEAN|0.105||0.4577|TWO_SIDED|95.0|-0.128|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.284|-0.128|0.4577
91537209|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.082|STANDARD_ERROR_OF_MEAN|0.092||0.3692|TWO_SIDED|95.0|-0.098|0.262|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.262|-0.098|0.3692
91537210|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.065|STANDARD_ERROR_OF_MEAN|0.09||0.4677|TWO_SIDED|95.0|-0.111|0.241|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.241|-0.111|0.4677
91537211|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.1|STANDARD_ERROR_OF_MEAN|0.106||0.3427|TWO_SIDED|95.0|-0.107|0.307|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.307|-0.107|0.3427
91537212|NCT00383188|182953553|SUPERIORITY||LSM Difference|0.135|STANDARD_ERROR_OF_MEAN|0.108||0.212|TWO_SIDED|95.0|-0.077|0.347|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.347|-0.077|0.2120
91537213|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.587|STANDARD_ERROR_OF_MEAN|0.337||0.0815|TWO_SIDED|95.0|-1.248|0.074|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.074|-1.248|0.0815
91537214|NCT00383188|182953554|SUPERIORITY||LSM Difference|-1.057|STANDARD_ERROR_OF_MEAN|0.331||0.0015|TWO_SIDED|95.0|-1.707|-0.407|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.407|-1.707|0.0015
91537215|NCT00383188|182953554|SUPERIORITY||LSM Difference|-1.107|STANDARD_ERROR_OF_MEAN|0.385||0.0042|TWO_SIDED|95.0|-1.863|-0.351|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.351|-1.863|0.0042
91537216|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.842|STANDARD_ERROR_OF_MEAN|0.398||0.0348|TWO_SIDED|95.0|-1.624|-0.06|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.060|-1.624|0.0348
91537217|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.442|STANDARD_ERROR_OF_MEAN|0.332||0.1843|TWO_SIDED|95.0|-1.095|0.211|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.095|0.1843
91537218|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.582|STANDARD_ERROR_OF_MEAN|0.327||0.076|TWO_SIDED|95.0|-1.225|0.061|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.061|-1.225|0.0760
91537219|NCT00383188|182953554|SUPERIORITY||LSM Difference|-1.019|STANDARD_ERROR_OF_MEAN|0.382||0.0078|TWO_SIDED|95.0|-1.769|-0.27|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.270|-1.769|0.0078
91537220|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.517|STANDARD_ERROR_OF_MEAN|0.395||0.1905|TWO_SIDED|95.0|-1.292|0.258|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.258|-1.292|0.1905
91537221|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.332||0.6552|TWO_SIDED|95.0|-0.801|0.504|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.504|-0.801|0.6552
91537222|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.327||0.0281|TWO_SIDED|95.0|-1.363|-0.078|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.078|-1.363|0.0281
91537223|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.382||0.0263|TWO_SIDED|95.0|-1.599|-0.1|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.100|-1.599|0.0263
91537224|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.429|STANDARD_ERROR_OF_MEAN|0.395||0.2772|TWO_SIDED|95.0|-1.204|0.346|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.346|-1.204|0.2772
91537225|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.024|STANDARD_ERROR_OF_MEAN|0.332||0.9433|TWO_SIDED|95.0|-0.676|0.629|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.629|-0.676|0.9433
91763014|NCT00412893|183416543|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-2.5|||||TWO_SIDED|95.0|-15.071|10.073|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.073|-15.071|
91763015|NCT00412893|183416543|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|2.9|||||TWO_SIDED|95.0|-8.633|14.499|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||14.499|-8.633|
91763016|NCT00412893|183416544|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|6.3|||||TWO_SIDED|95.0|-5.145|17.696|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.696|-5.145|
91763017|NCT00412893|183416544|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.0|||||TWO_SIDED|95.0|-3.335|19.356|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||19.356|-3.335|
91763018|NCT00412893|183416544|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.1|||||TWO_SIDED|95.0|-6.187|16.332|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||16.332|-6.187|
91763019|NCT03951077|183416546|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.3|TWO_SIDED|90.0|-15.38|3.49|||Cochran-Mantel-Haenszel|||Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.49|-15.38|0.300
91763020|NCT03951077|183416546|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.32|TWO_SIDED|90.0|-15.65|3.86|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.86|-15.65|0.320
91537226|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.768|STANDARD_ERROR_OF_MEAN|0.327||0.193|TWO_SIDED|95.0|-1.41|-0.125|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.125|-1.410|0.193
91537227|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.763|STANDARD_ERROR_OF_MEAN|0.382||0.461|TWO_SIDED|95.0|-1.512|-0.013|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.013|-1.512|0.461
91537228|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.254|STANDARD_ERROR_OF_MEAN|0.395||0.52|TWO_SIDED|95.0|-1.029|0.521|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.521|-1.029|0.5200
91537229|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.476|STANDARD_ERROR_OF_MEAN|0.332||0.1526|TWO_SIDED|95.0|-1.129|0.177|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.177|-1.129|0.1526
91537230|NCT00383188|182953554|SUPERIORITY||LSM Difference|-1.095|STANDARD_ERROR_OF_MEAN|0.327||0.0009|TWO_SIDED|95.0|-1.738|-0.453|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.453|-1.738|0.0009
91537231|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.523|STANDARD_ERROR_OF_MEAN|0.382||0.1711|TWO_SIDED|95.0|-1.273|0.227|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.227|-1.273|0.1711
91537232|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.563|STANDARD_ERROR_OF_MEAN|0.395||0.1539|TWO_SIDED|95.0|-1.338|0.211|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.338|0.1539
91537233|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.512|STANDARD_ERROR_OF_MEAN|0.36||0.1554|TWO_SIDED|95.0|-1.219|0.195|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.195|-1.219|0.1554
91537234|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.889|STANDARD_ERROR_OF_MEAN|0.354||0.0124|TWO_SIDED|95.0|-1.585|-0.193|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.193|-1.585|0.0124
91537235|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.914|STANDARD_ERROR_OF_MEAN|0.412||0.0268|TWO_SIDED|95.0|-1.723|-0.106|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.723|0.0268
91537236|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.681|STANDARD_ERROR_OF_MEAN|0.427||0.1113|TWO_SIDED|95.0|-1.519|0.158|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.158|-1.519|0.1113
91537237|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.1305|TWO_SIDED|95.0|-1.24|0.16|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.160|-1.240|0.1305
91537238|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.571|STANDARD_ERROR_OF_MEAN|0.351||0.1043|TWO_SIDED|95.0|-1.261|0.118|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.118|-1.261|0.1043
91537239|NCT00383188|182953554|SUPERIORITY||LSM Difference|-1.017|STANDARD_ERROR_OF_MEAN|0.409||0.0131|TWO_SIDED|95.0|-1.82|-0.214|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.214|-1.820|0.0131
91763021|NCT03951077|183416546|SUPERIORITY||Adjusted Response Rate Difference|-5.6||||0.315|TWO_SIDED|90.0|-14.87|3.59|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.59|-14.87|0.315
91763022|NCT03951077|183416546|SUPERIORITY||Adjusted Response Rate Difference|-6.7||||0.265|TWO_SIDED|90.0|-16.63|3.19|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.19|-16.63|0.265
91537240|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.492|STANDARD_ERROR_OF_MEAN|0.424||0.2459|TWO_SIDED|95.0|-1.324|0.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.340|-1.324|0.2459
91537241|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.221|STANDARD_ERROR_OF_MEAN|0.356||0.536|TWO_SIDED|95.0|-0.921|0.479|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.479|-0.921|0.5360
91537242|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.465|STANDARD_ERROR_OF_MEAN|0.351||0.1858|TWO_SIDED|95.0|-1.155|0.225|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.225|-1.155|0.1858
91537243|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.821|STANDARD_ERROR_OF_MEAN|0.409||0.0451|TWO_SIDED|95.0|-1.624|-0.018|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.018|-1.624|0.0451
91537244|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.189|STANDARD_ERROR_OF_MEAN|0.424||0.6551|TWO_SIDED|95.0|-1.021|0.643|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.643|-1.021|0.6551
91537245|NCT00383188|182953554|SUPERIORITY||LSM Difference|0.018|STANDARD_ERROR_OF_MEAN|0.356||0.9602|TWO_SIDED|95.0|-0.682|0.718|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.718|-0.682|0.9602
91537246|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.351||0.0198|TWO_SIDED|95.0|-1.51|-0.131|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.131|-1.510|0.0198
91537247|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.948|STANDARD_ERROR_OF_MEAN|0.409||0.0208|TWO_SIDED|95.0|-1.751|-0.145|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.145|-1.751|0.0208
91537248|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.433|STANDARD_ERROR_OF_MEAN|0.424||0.3077|TWO_SIDED|95.0|-1.265|0.4|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.400|-1.265|0.3077
91537249|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.356||0.555|TWO_SIDED|95.0|-0.911|0.49|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.490|-0.911|0.5550
91537250|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.795|STANDARD_ERROR_OF_MEAN|0.351||0.0239|TWO_SIDED|95.0|-1.485|-0.106|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.485|0.0239
91537251|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.613|STANDARD_ERROR_OF_MEAN|0.409||0.1342|TWO_SIDED|95.0|-1.416|0.19|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.190|-1.416|0.1342
91537252|NCT00383188|182953554|SUPERIORITY||LSM Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.424||0.3868|TWO_SIDED|95.0|-1.199|0.465|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.465|-1.199|0.3868
91537253|NCT00383188|182953555|SUPERIORITY||LSM Difference|0.792|STANDARD_ERROR_OF_MEAN|1.093||0.4693|TWO_SIDED|95.0|-1.357|2.941|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.941|-1.357|0.4693
91537254|NCT00383188|182953555|SUPERIORITY||LSM Difference|1.927|STANDARD_ERROR_OF_MEAN|1.077||0.0743|TWO_SIDED|95.0|-0.19|4.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.044|-0.190|0.0743
91537255|NCT00383188|182953555|SUPERIORITY||LSM Difference|4.196|STANDARD_ERROR_OF_MEAN|1.286||0.0012|TWO_SIDED|95.0|1.668|6.723|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||6.723|1.668|0.0012
91537256|NCT00383188|182953555|SUPERIORITY||LSM Difference|1.236|STANDARD_ERROR_OF_MEAN|1.308||0.3452|TWO_SIDED|95.0|-1.335|3.807|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.807|-1.335|0.3452
91763023|NCT03951077|183416546|SUPERIORITY||Adjusted Response Rate Difference|-0.8||||0.914|TWO_SIDED|90.0|-13.1|11.48|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||11.48|-13.10|0.914
91763024|NCT03951077|183416547|SUPERIORITY||Least Squares (LS) Mean of Difference|-5.93|STANDARD_ERROR_OF_MEAN|3.429||0.087|TWO_SIDED|90.0|-11.628|-0.231|||MMRM|||P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.231|-11.628|0.087
91763025|NCT03951077|183416547|SUPERIORITY||LS Mean of Difference|-8.83|STANDARD_ERROR_OF_MEAN|3.435||0.012|TWO_SIDED|90.0|-14.533|-3.118|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-3.118|-14.533|0.012
91763026|NCT03951077|183416547|SUPERIORITY||LS Mean of Difference|-16.1|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|90.0|-21.673|-10.519|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-10.519|-21.673|<0.001
91763027|NCT03951077|183416547|SUPERIORITY||LS Mean of Difference|-6.15|STANDARD_ERROR_OF_MEAN|3.593||0.091|TWO_SIDED|90.0|-12.116|-0.176|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.176|-12.116|0.091
91763028|NCT03951077|183416547|SUPERIORITY||LS Mean of Difference|-11.72|STANDARD_ERROR_OF_MEAN|3.431|<|0.001|TWO_SIDED|90.0|-17.418|-6.016|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-6.016|-17.418|< 0.001
91763029|NCT00086047|183416548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_DEVIATION|8.8||0.007|TWO_SIDED|95.0|1.57|9.22|||Mixed Models Analysis|||||9.22|1.57|0.007
91763030|NCT01395901|183416551|NON_INFERIORITY_OR_EQUIVALENCE|For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.|Risk Difference (RD)|-4.4|||||TWO_SIDED|95.0|-10.5|1.7||||||"The null hypothesis (H0) was stated as:~• H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \<-10%~The alternative hypothesis (H1) was stated as:~• H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \>-10%~A power of 80% was used for sample size computation."||1.7|-10.5|
91763031|NCT01751984|183416602|SUPERIORITY||Least squares mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.4|-22.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-22.1|-35.4|<0.0001
91763032|NCT01751984|183416603|SUPERIORITY||Least squares mean difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-24.3|-11.8|||ANCOVA||Estimation from Week 2. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-11.8|-24.3|<0.0001
91763033|NCT01751984|183416603|SUPERIORITY||Least squares mean difference|-30.0|||<|0.0001|TWO_SIDED|95.0|-35.2|-24.7|||ANCOVA||Estimation from Week 4. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-24.7|-35.2|<0.0001
91763034|NCT01751984|183416603|SUPERIORITY||Least squares mean difference|-28.8|||<|0.0001|TWO_SIDED|95.0|-36.9|-20.8|||ANCOVA||Estimation from Week 6. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-20.8|-36.9|<0.0001
91763035|NCT01751984|183416603|SUPERIORITY||Least squares mean difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.2|-19.8|||ANCOVA||Estimation from Week 8. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-19.8|-37.2|<0.0001
91763036|NCT01751984|183416604|SUPERIORITY||Least squares mean difference|-5.8||||0.1892|TWO_SIDED|95.0|-14.5|2.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||2.9|-14.5|0.1892
91763037|NCT01751984|183416605|SUPERIORITY||Least squares mean difference|-20.9|||<|0.0001|TWO_SIDED|95.0|-28.0|-13.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-13.9|-28.0|<0.0001
91763038|NCT01751984|183416606|SUPERIORITY||Least squares mean difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-24.2|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-12.7|-24.2|<0.0001
91763039|NCT01751984|183416607|SUPERIORITY||Least squares mean difference|18.7|||=|0.0962|TWO_SIDED|95.0|-3.5|40.8|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||40.8|-3.5|=0.0962
91763040|NCT01751984|183416608|SUPERIORITY||Least squares mean difference|-15.3|||=|0.0019|TWO_SIDED|95.0|-24.6|-6.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-6.0|-24.6|=0.0019
91763041|NCT01751984|183416609|SUPERIORITY||Least squares mean difference|-4.2|||=|0.2555|TWO_SIDED|95.0|-11.7|3.2|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||3.2|-11.7|=0.2555
91763042|NCT01751984|183416610|SUPERIORITY||Least squares mean difference|11.7||||0.2563|TWO_SIDED|95.0|-8.8|32.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.1|-8.8|0.2563
91537257|NCT00383188|182953555|SUPERIORITY||LSM Difference|1.095|STANDARD_ERROR_OF_MEAN|1.091||0.3162|TWO_SIDED|95.0|-1.05|3.239|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.239|-1.050|0.3162
91537258|NCT00383188|182953555|SUPERIORITY||LSM Difference|2.514|STANDARD_ERROR_OF_MEAN|1.072||0.0195|TWO_SIDED|95.0|0.406|4.622|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.622|0.406|0.0195
91537259|NCT00383188|182953555|SUPERIORITY||LSM Difference|2.762|STANDARD_ERROR_OF_MEAN|1.283||0.032|TWO_SIDED|95.0|0.239|5.285|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||5.285|0.239|0.0320
91537260|NCT00383188|182953555|SUPERIORITY||LSM Difference|0.268|STANDARD_ERROR_OF_MEAN|1.29||0.8356|TWO_SIDED|95.0|-2.268|2.804|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.804|-2.268|0.8356
91537261|NCT00383188|182953555|SUPERIORITY||LSM Difference|-0.904|STANDARD_ERROR_OF_MEAN|1.626||0.5787|TWO_SIDED|95.0|-4.101|2.293|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||2.293|-4.101|0.5787
91537262|NCT00383188|182953555|SUPERIORITY||LSM Difference|1.291|STANDARD_ERROR_OF_MEAN|1.6||0.4203|TWO_SIDED|95.0|-1.854|4.436|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.436|-1.854|0.4203
91537263|NCT00383188|182953555|SUPERIORITY||LSM Difference|2.318|STANDARD_ERROR_OF_MEAN|1.916||0.2272|TWO_SIDED|95.0|-1.449|6.084|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.084|-1.449|0.2272
91763043|NCT01751984|183416611|SUPERIORITY||Least squares mean difference|-23.7||||0.2565|TWO_SIDED|95.0|-65.4|18.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||18.0|-65.4|0.2565
91763044|NCT01751984|183416612|SUPERIORITY||Least squares mean difference|4.0||||0.776|TWO_SIDED|95.0|-24.1|32.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.0|-24.1|0.7760
91763045|NCT01751984|183416613|SUPERIORITY||Clopper-Pearson methodology|61.8|||<|0.0001|TWO_SIDED|95.0|45.4|78.1||Based on Fisher's exact test comparing the proportion of participants who achieved LDL-C goal at Week 8 (End of Study) in the ETC-1002 and placebo groups.|Fisher Exact||ETC-1002 minus placebo for the proportion of participants who achieved LDL-C goal at Week 8 (End of Study). The confidence interval was based on a normal approximation to the binomial distribution.|||78.1|45.4|<0.0001
91763046|NCT00587158|183416616|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Fisher Exact|||||||0.0005
91763047|NCT00587158|183416617|SUPERIORITY_OR_OTHER|||||||0.4571||95.0|||||Fisher Exact|||||||0.4571
91763048|NCT00587158|183416618|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Fisher Exact|||||||0.2290
91763049|NCT00587158|183416619|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at baseline was compared between the two treatment groups.||||0.17
91763050|NCT00587158|183416619|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 21 days was compared between the two treatment groups.||||0.005
91763051|NCT00587158|183416619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 90 days was compared between the two treatment groups.||||<0.0001
91763052|NCT00587158|183416619|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at one year was compared between the two treatment groups.||||0.0004
91763053|NCT00587158|183416620|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at baseline was compared between the two treatment groups.||||0.833
91763054|NCT00587158|183416620|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 21 days was compared between the two treatment groups.||||0.553
91763055|NCT00587158|183416620|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 90 days was compared between the two treatment groups.||||0.035
91763056|NCT00587158|183416620|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at one year was compared between the two treatment groups.||||0.171
91763057|NCT00587158|183416621|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
91763058|NCT00587158|183416622|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
91763059|NCT00587158|183416625|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
91763060|NCT00587158|183416626|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
91763061|NCT00587158|183416627|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
91763062|NCT00587158|183416628|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||The number of subjects with mild interstitial fibrosis (Banff ci score \> 0 and \< 2) at one year was compared between treatment groups.||||1.0
91763063|NCT00587158|183416628|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||The number of subjects with moderate to mild interstitial fibrosis (Banff ci score greater than or equal to 2) at one year was compared between treatment groups.||||0.04
91763064|NCT01915173|183416661|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.01
91763065|NCT01915173|183416661|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.33
91763066|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.86||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Arm A vs Arm B shift test on Angiopoietin -- 2 prior to cycle 2. Wilcoxon rank-sum test p-value.||||0.86
91537264|NCT00383188|182953555|SUPERIORITY||LSM Difference|0.829|STANDARD_ERROR_OF_MEAN|1.947||0.6707|TWO_SIDED|95.0|-2.998|4.655|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.655|-2.998|0.6707
91537265|NCT00383188|182953555|SUPERIORITY||LSM Difference|0.425|STANDARD_ERROR_OF_MEAN|1.622||0.7935|TWO_SIDED|95.0|-2.764|3.613|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||3.613|-2.764|0.7935
91537266|NCT00383188|182953555|SUPERIORITY||LSM Difference|2.525|STANDARD_ERROR_OF_MEAN|1.592||0.1135|TWO_SIDED|95.0|-0.605|5.655|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.655|-0.605|0.1135
91537267|NCT00383188|182953555|SUPERIORITY||LSM Difference|2.63|STANDARD_ERROR_OF_MEAN|1.912||0.1697|TWO_SIDED|95.0|-1.128|6.388|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.388|-1.128|0.1697
91537268|NCT00383188|182953555|SUPERIORITY||LSM Difference|2.21|STANDARD_ERROR_OF_MEAN|1.918||0.25|TWO_SIDED|95.0|-1.561|5.981|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.981|-1.561|0.2500
91537269|NCT01544062|182953564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.024|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.024
91537270|NCT01544062|182953564|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.013
91537271|NCT01544062|182953565|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||t-test, 2 sided|||||||0.059
91537272|NCT01544062|182953565|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.020
91537273|NCT01544062|182953566|SUPERIORITY_OR_OTHER|||||||0.724|TWO_SIDED||||||t-test, 2 sided|||||||0.724
91537274|NCT01544062|182953566|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.510
91537275|NCT01544062|182953567|SUPERIORITY_OR_OTHER|||||||0.397|TWO_SIDED||||||t-test, 2 sided|||||||0.397
91537276|NCT01544062|182953567|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.458
91763067|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.76||||||Angiopoietin -- 2 prior to cycle 3.|Wilcoxon (Mann-Whitney)|||Angiopoietin -- 2 prior to cycle 3||||0.76
91763068|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.14||||||No adjustment for multiple comparison. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie--2 Prior to cycle 2||||0.14
91537277|NCT01544062|182953568|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.600
91537278|NCT01544062|182953568|SUPERIORITY_OR_OTHER|||||||0.509|TWO_SIDED||||||ANCOVA|controlling for age, sex and body mass index||||||0.509
91537279|NCT01544062|182953569|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
91537280|NCT01544062|182953569|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.395
91537281|NCT01544062|182953570|SUPERIORITY_OR_OTHER|||||||0.771|TWO_SIDED||||||t-test, 2 sided|||||||0.771
91537282|NCT01544062|182953570|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.927
91763069|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie -- 2 prior to cycle 3||||0.069
91763070|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.19||||||P-value is not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF -- A prior to cycle 2||||0.19
91763071|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||P-value is not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF--A prior to cycle 3||||0.046
91537283|NCT01544062|182953571|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||t-test, 2 sided|||||||0.644
91537284|NCT01544062|182953571|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.160
91537285|NCT01544062|182953572|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.710
91537286|NCT01544062|182953572|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.475
91537287|NCT01544062|182953573|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|||||||0.508
91537288|NCT01544062|182953573|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.905
91537289|NCT01544062|182953574|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||t-test, 2 sided|||||||0.104
91537290|NCT01544062|182953575|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|||||||0.580
91537291|NCT01544062|182953576|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.619
91537292|NCT01544062|182953577|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||Fisher Exact|||||||0.511
91537293|NCT01544062|182953578|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||Fisher Exact|||||||0.501
91537294|NCT01544062|182953579|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
91537295|NCT01544062|182953580|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||||||0.299
91537296|NCT01544062|182953581|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
91537297|NCT01544062|182953582|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Fisher Exact|||||||0.492
91537298|NCT01544062|182953583|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||||||0.455
91537299|NCT01544062|182953584|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
91537300|NCT00414206|182953585|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
91537301|NCT01144182|182953587|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED|||||For this pilot study, significance level was set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||.56
91537302|NCT01144182|182953588|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.22
91537303|NCT01144182|182953589|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
91537304|NCT01144182|182953590|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
91537305|NCT01144182|182953591|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
91537306|NCT01144182|182953592|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
91537307|NCT01144182|182953593|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
91537308|NCT01144182|182953594|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
91537309|NCT01144182|182953595|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
91537310|NCT01144182|182953596|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
91537311|NCT01144182|182953597|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
91537312|NCT01144182|182953598|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
91537313|NCT01144182|182953599|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.36
91537314|NCT01670110|182953603|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
91537315|NCT01670110|182953604|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
91537316|NCT01670110|182953605|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91537317|NCT01670110|182953606|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91537318|NCT01670110|182953607|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91537319|NCT01670110|182953608|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91537320|NCT01670110|182953609|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
91537321|NCT01670110|182953610|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Physical functioning||||0.31
91537322|NCT01670110|182953610|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Physical role||||0.48
91537323|NCT01670110|182953610|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Bodily pain||||0.89
91537324|NCT01670110|182953610|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||General health||||0.18
91537325|NCT01670110|182953610|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Vitality||||0.28
91537326|NCT01670110|182953610|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Social functioning||||0.66
91537327|NCT01670110|182953610|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Role emotional||||0.43
91537328|NCT01670110|182953610|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Mental health||||0.51
91537329|NCT03693742|182953622|SUPERIORITY||||||<|0.001||||||A P value of less than 0.05 was considered significant.|Mixed Models Analysis|||"Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups.~A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05."||||<0.001
91537330|NCT00798265|182953648|OTHER|||||||0.002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||0.0020
91537331|NCT00798265|182953648|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||<.0001
91537332|NCT00798265|182953648|OTHER|||||||0.0002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||0.0002
91537333|NCT00798265|182953648|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||<.0001
91537334|NCT04411082|182953673|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91537335|NCT04411082|182953674|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91537336|NCT04411082|182953675|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91537337|NCT04411082|182953676|SUPERIORITY||||||>|0.4839|||||||Fisher Exact|||||||>0.4839
91513885|NCT00856583|182899855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|95.0|0.7|1.85|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.85|0.70|0.59
91513886|NCT00856583|182899856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.29|0.66|0.65
91513887|NCT00856583|182899857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.044|TWO_SIDED|95.0|0.45|0.99|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||0.99|0.45|0.044
91513888|NCT00856583|182899858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.04|TWO_SIDED|95.0|1.01|1.57|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.57|1.01|0.040
91513889|NCT00856583|182899859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.28|1.43|||Cox Proportional Hazard|Adjusted: disease duration, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.43|1.28|<0.0001
91513890|NCT03299192|182899879|SUPERIORITY|||||||0.001||||||This feasibility study is small and not designed to look at outcome statistics|GEE with Ancova features|||||||.001
91513891|NCT01418209|182899885|SUPERIORITY_OR_OTHER|||||||0.02||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
91513892|NCT01418209|182899885|SUPERIORITY_OR_OTHER|||||||0.02||||||p-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold of statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
91513893|NCT01418209|182899886|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||<0.001
91513894|NCT01418209|182899886|SUPERIORITY_OR_OTHER|||||||0.005||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||0.005
91513895|NCT01418209|182899888|SUPERIORITY_OR_OTHER|||||||0.01||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.01
91513896|NCT01418209|182899888|SUPERIORITY_OR_OTHER|||||||0.07||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.07
91513897|NCT01418209|182899890|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo.||||<0.001
91513898|NCT01418209|182899890|SUPERIORITY_OR_OTHER|||||||0.03||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.03
91513899|NCT03779841|182899891|SUPERIORITY||Risk Ratio (RR)|0.8||||0.1612|TWO_SIDED|95.0|0.58|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.58|0.1612
91513900|NCT03779841|182899891|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7789|TWO_SIDED|95.0|0.79|1.37|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.37|0.79|0.7789
91537338|NCT04411082|182953677|SUPERIORITY|||||||0.2065|||||||Fisher Exact|||||||0.2065
91537339|NCT04411082|182953678|SUPERIORITY|||||||0.4839|||||||Fisher Exact|||||||0.4839
91537340|NCT04411082|182953679|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91537341|NCT04411082|182953680|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91537342|NCT03538041|182953699|SUPERIORITY|||||||0.2815|||||||ANOVA|||Week 2||||0.2815
91537343|NCT03538041|182953700|SUPERIORITY|||||||0.2921|||||||Kruskal-Wallis|||Week 2||||0.2921
91537344|NCT03538041|182953701|SUPERIORITY|||||||0.1267|||||||ANOVA|||Week 2||||0.1267
91537345|NCT03538041|182953702|SUPERIORITY|||||||0.2676|||||||ANOVA|||Week 2||||0.2676
91537346|NCT00094809|182953713|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.1|0.37|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||0.37|0.10|<0.0001
91537347|NCT00094809|182953714|SUPERIORITY_OR_OTHER||Treatment difference|-18.0|||<|0.0001||95.0|-26.2|-9.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||-9.8|-26.2|<0.0001
91537348|NCT00094809|182953715|SUPERIORITY_OR_OTHER||Treatment difference|-12.0||||0.0646||95.0|-23.7|0.5|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||0.5|-23.7|0.0646
91537349|NCT00094809|182953716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0384||95.0|0.07|1.0|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of pegfilgrastim group compared to placebo group|||1.00|0.07|0.0384
91537350|NCT00094809|182953717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5514||95.0|0.26|2.04|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||2.04|0.26|0.5514
91537351|NCT00094809|182953719|SUPERIORITY_OR_OTHER||Treatment difference|-3.5||||0.5434||95.0|-14.8|7.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference (pegfilgrastim group - placebo group) in the percentage of participants with a complete or partial response|||7.8|-14.8|0.5434
91763072|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.029||||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF Prior to Cycle 2||||0.029
91537352|NCT00094809|182953720|SUPERIORITY_OR_OTHER||Treatment difference|-12.1||||||95.0|-28.1|4.0|||||Kaplan-Meier estimates of the difference in percent mortality for the pegfilgrastim group - placebo group. Median survival time was not reached for the pegfilgrastim group.|||4.0|-28.1|
91537353|NCT00094809|182953721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.0457||95.0|0.05|1.09|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||1.09|0.05|0.0457
91537354|NCT00094809|182953722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3792||95.0|0.32|1.53|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||1.53|0.32|0.3792
91537355|NCT02469064|182953726|OTHER||Hazard Ratio (HR)|0.82||||0.84|TWO_SIDED|95.0|0.55|1.2|||Mann Whitneey||Univariate analysis of the probability of extubation was performed using Kaplan-Meir survival analysis and the logrank test.The multivariate analysis was performed by cox regression, a simple model was performed and a final model.|||1.20|0.55|0.84
91537356|NCT02469064|182953727|OTHER||Slope|0.46||||0.48|TWO_SIDED|95.0|-3.75|4.78|||t-test, 2 sided||The slope shows the difference between the means of the change in the MIP of the group that received the experimental treatment and the group that received the conventional treatment|||4.78|-3.75|0.48
91537357|NCT00964366|182953737|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||> 0.05
91537358|NCT00964366|182953739|SUPERIORITY_OR_OTHER||||||<|0.05||||||Dapsone versus Clindamycin/BPO gel.|Dunn's Multiple Comparisons Test|||||||< 0.05
91537359|NCT00964366|182953740|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91537360|NCT00964366|182953741|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91537361|NCT05372094|182953742|OTHER|||||||0.007|||||||Mixed Models Analysis|||Fixed factor of program and random intercept of participant||||0.007
91537362|NCT05372094|182953742|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting OFF and noise reduction setting STRONG||||< 0.05
91537363|NCT05372094|182953742|OTHER||||||<|0.01|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAK||||<0.01
91537364|NCT05372094|182953742|OTHER||||||>|0.05|||||||Mixed Models Analysis|||"Follow up comparison between ratings of effort with OFF and WEAK"||||>.05
91763073|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.2||||||P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF prior to cycle 3||||0.20
91537365|NCT05372094|182953743|OTHER|||||||0.283|||||||Mixed Models Analysis|||||||0.283
91537366|NCT05372094|182953744|OTHER|||||||0.145|||||||Mixed Models Analysis|||Analysis was done only between NR OFF and NR at a custom or preferred setting.||||0.145
91537367|NCT05372094|182953745|OTHER|||||||0.3018|||||||Exact Binomial test|||An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.||||0.3018
91537368|NCT05372094|182953746|OTHER|||||||0.1796|||||||Exact Binomial test|||Exact binomial test was done to evaluate if the majority (\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.||||0.1796
91537369|NCT02957539|182953769|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|97.5|-10.7|1.6|||||Change in weight from baseline to week 32 in the financial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||1.6|-10.7|
91537370|NCT02957539|182953769|SUPERIORITY||Mean Difference (Net)|-5.0|||<|0.025|TWO_SIDED|97.5|-11.1|1.0|||t-test, 2 sided||Change in weight from baseline to week 32 in the non-financial arm minus the change in weight from baseline to week 32 in the no rewards arm|||1|-11.1|<0.025
91537371|NCT02957539|182953770|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.5|1.8|||||Change in Self Efficacy score from baseline to week 16 in the financial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.8|-0.5|
91537372|NCT02957539|182953770|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-0.8|1.5|||||Change in Self Efficacy score from baseline to week 16 in the nonfinancial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.5|-0.8|
91763074|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 2||||0.11
91763075|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.068||||||P-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 3||||0.068
91763076|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 2||||0.61
91763077|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.27||||||Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 3||||0.27
91763078|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 2||||0.61
91763079|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.49||||||The p-value was not adjusted for multiple comparisons, and the a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 3||||0.49
91763080|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.82||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 2||||0.82
91763081|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 3||||0.069
91763082|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.34||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 2||||0.34
91763083|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 3||||0.046
91763084|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 2||||0.11
91763085|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.23||||||The p-value was adjusted for multiple comparisons. The a prior threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 3||||0.23
91763086|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.37||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 2||||0.37
91763087|NCT01664182|183416677|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.35||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 3||||0.35
91763088|NCT05292131|183416687|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC.|Geometric Mean Ratio (percentage [%])|97.5|||||TWO_SIDED|90.0|90.2|105.4||||||||105.40|90.20|
91763089|NCT05292131|183416688|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC0-t.|Geometric Mean Ratio (%)|97.05|||||TWO_SIDED|90.0|90.1|104.55||||||||104.55|90.10|
91537373|NCT02957539|182953771|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|97.5|-1.2|1.4|||||The change in self efficacy from baseline to week 32 in the financial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.4|-1.2|
91763090|NCT05292131|183416689|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for Cmax.|Geometric Mean Ratio (%)|96.21|||||TWO_SIDED|90.0|88.6|104.47||||||||104.47|88.60|
91763091|NCT05292131|183416692|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for t½.|Geometric Mean Ratio (%)|101.13|||||TWO_SIDED|90.0|94.18|108.59||||||||108.59|94.18|
91763092|NCT05292131|183416693|EQUIVALENCE|The point estimate and the 90% CI for the median treatment differences for tmax was computed according to the Hodges-Lehmann's method.|Hodges-Lehman Estimate|0.4897|||||TWO_SIDED|90.0|-0.0073|0.9567||||||||0.9567|-0.0073|
91763093|NCT01345188|183416694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|||||||Paired t test|||||||0.058
91763094|NCT01345188|183416695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||Paired t test|||||||0.048
91763095|NCT01345188|183416696|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon Signed rank|||||||>0.05
91537374|NCT02957539|182953771|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.9|1.8|||||The change in self efficacy from baseline to week 32 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.8|-.9|
91537375|NCT02957539|182953772|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|97.5|0.2|2.8|||||The change in self efficacy from baseline to week 52 in the financial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.8|0.2|
91537376|NCT02957539|182953772|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|97.5|0.0|2.3|||||The change in self efficacy from baseline to week 52 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.3|0.0|
91537377|NCT02957539|182953773|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|97.5|-0.4|0.9|||||Change in intrinsic motivation score from baseline to week 16 in the financial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.9|-0.4|
91537378|NCT02957539|182953773|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|97.5|-0.6|0.7|||||Change in intrinsic motivation score from baseline to week 16 in the nonfinancial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.7|-0.6|
91537379|NCT02957539|182953774|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.2|1.3|||||The change in intrinsic motivation from baseline to week 32 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.3|-0.2|
91537380|NCT02957539|182953774|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.3|1.6|||||The change in intrinsic motivation from baseline to week 32 in the nonfinancial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.6|-0.3|
91537381|NCT02957539|182953775|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|97.5|-0.5|1.5|||||The change in intrinsic motivation from baseline to week 52 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 52 in the no rewards arm|||1.5|-0.5|
91537382|NCT02957539|182953775|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|97.5|-0.8|1.6|||||Incentive Group minus usual care|||1.6|-0.8|
91537383|NCT02957539|182953776|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.0|2.6|||||Change in PHQ-8 score from baseline to week 16 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 16 in the no rewards arm.|||2.6|-2.0|
91537384|NCT02957539|182953776|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|97.5|-1.5|2.9|||||Change in PHQ-9 from week baseline to week 16 in the non-financial incentive group minus the change from week baseline to week 16 in the no rewards group|||2.9|-1.5|
91537385|NCT02957539|182953777|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|97.5|-1.7|4.5|||||The change in PHQ-8 from baseline to week 32 in the financial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||4.5|-1.7|
91537386|NCT02957539|182953777|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|97.5|-0.7|5.0|||||The change in PHQ-8 from baseline to week 32 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||5.0|-0.7|
91537387|NCT02957539|182953778|SUPERIORITY||Mean Difference (Net)|-1.1|||||TWO_SIDED|97.5|-4.9|2.8|||||Change in PHQ-8 score from baseline to week 52 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 52 in the no rewards arm.|||2.8|-4.9|
91537388|NCT02957539|182953778|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.9|3.6|||||The change in PHQ-8 from baseline to week 52 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 52 in the no rewards arm|||3.6|-2.9|
91537389|NCT02957539|182953779|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|97.5|-7.4|1.0|||||Change in weight from baseline to week 16 in the financial rewards arm minus the change in weight from baseline to week 16 in the no rewards arm.|||1|-7.4|
91537390|NCT02957539|182953779|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|97.5|-8.7|-0.4|||||Change in weight from baseline to week 16 in the nonfinancial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||-0.4|-8.7|
91537391|NCT02957539|182953780|SUPERIORITY||Mean Difference (Net)|2.4|||||TWO_SIDED|97.5|-6.0|10.7|||||Change in weight from baseline to week 52 in the financial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||10.7|-6|
91537392|NCT02957539|182953780|SUPERIORITY||Mean Difference (Net)|-3.6|||||TWO_SIDED|97.5|-11.2|4.1|||||Change in weight from baseline to week 52 in the nonfinancial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||4.1|-11.2|
91537393|NCT01689519|182953797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0001|TWO_SIDED|95.0|0.39|0.68||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||0.68|0.39|0.0001
91537394|NCT01689519|182953797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.72||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Efficacy Analysis: 16 January 2015||0.72|0.46|<0.0001
91537395|NCT01689519|182953797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Extended 5-Year Analysis: 21 July 2019||0.79|0.53|<0.0001
91537396|NCT01689519|182953798|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.645||||0.0463|TWO_SIDED|95.0|0.42|1.0||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||1.00|0.42|0.0463
91537397|NCT01689519|182953798|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.0034|TWO_SIDED|95.0|0.49|0.87||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Analysis 16 January 2015||0.87|0.49|0.0034
91537398|NCT01689519|182953798|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Final Analysis 28 August 2015||0.90|0.55|0.0050
91537399|NCT01689519|182953799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.85|||<|0.0001|TWO_SIDED|95.0|14.13|31.58|||Chi-squared|||Primary Analysis: 9 May 2014||31.58|14.13|<0.0001
91537400|NCT01689519|182953799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.6|||<|0.0001|TWO_SIDED|95.0|11.0|28.3|||Chi-squared|||Post hoc Efficacy Analysis: 16 January 2015||28.3|11.0|<0.0001
91537401|NCT01689519|182953799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|||<|0.0001|TWO_SIDED|95.0|11.4|28.7|||Chi-squared|||Extended 5-Year Analysis: 21 July 2019||28.70|11.40|<0.0001
91537402|NCT01245439|182953820|SUPERIORITY_OR_OTHER|||||||0.929|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.929
91537403|NCT01245439|182953820|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to 3||||<0.001
91763096|NCT04607837|183416714|SUPERIORITY||Risk Difference (RD)|7.35||||0.2524|TWO_SIDED|95.0|-5.24|19.94|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common risk difference using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the risk difference being 0.||19.94|-5.24|0.2524
91537404|NCT01245439|182953820|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||<0.001
91513901|NCT03779841|182899892|SUPERIORITY|||||||0.2972|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.2972
91537405|NCT01245439|182953820|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.050
91537406|NCT01245439|182953820|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.165
91763097|NCT04607837|183416715|SUPERIORITY||Risk Difference (RD)|15.61||||0.0068|TWO_SIDED|95.0|4.31|26.91|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.91|4.31|0.0068
91537407|NCT01245439|182953820|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.133
91537408|NCT01245439|182953820|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.217
91537409|NCT01245439|182953820|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
91537410|NCT01245439|182953823|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.169
91537411|NCT01245439|182953823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
91513902|NCT03779841|182899892|SUPERIORITY|||||||0.8722|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8722
91537412|NCT01245439|182953823|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.053
91537413|NCT01245439|182953823|SUPERIORITY_OR_OTHER|||||||0.514|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.514
91537414|NCT01245439|182953823|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.064
91537415|NCT01245439|182953823|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.038
91537416|NCT01245439|182953823|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.064
91537417|NCT01245439|182953823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
91537418|NCT01245439|182953824|SUPERIORITY_OR_OTHER|||||||0.981|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.981
91537419|NCT01245439|182953824|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
91537420|NCT01245439|182953824|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.005
91537421|NCT01245439|182953824|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.566
91537422|NCT01245439|182953824|SUPERIORITY_OR_OTHER|||||||0.264|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.264
91537423|NCT01245439|182953824|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.126
91537424|NCT01245439|182953824|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.779
91537425|NCT01245439|182953824|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||||||<0.001
91537426|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints Visit 1 to Visit 2||||0.410
91537427|NCT01245439|182953825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 3||||<0.001
91537428|NCT01245439|182953825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 3 to Visit 4||||<0.001
91537429|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 4 to Visit 5||||0.021
91537430|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 5 to Visit 6||||0.003
91537431|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.827|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 6 to Visit7||||0.827
91537432|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 7 to Visit 8||||0.093
91537433|NCT01245439|182953825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 8||||<0.001
91537434|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 1 to Visit 2||||0.792
91537435|NCT01245439|182953825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 3||||<0.001
91537436|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 3 to Visit 4||||0.002
91537437|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 4 to Visit 5||||0.374
91537438|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 5 to Visit 6||||0.518
91537439|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 6 to Visit 7||||0.744
91537440|NCT01245439|182953825|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 7 to Visit 8||||0.048
91537441|NCT01245439|182953825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 8||||<0.001
91537442|NCT01245439|182953826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 3||||<0.001
91537443|NCT01245439|182953826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 3 to Visit 4||||<0.001
91537444|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 4 to Visit 5||||0.075
91537445|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 5 to Visit 6||||0.119
91537446|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 6 to Visit 7||||0.007
91537447|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 7 to Visit 8||||0.047
91537448|NCT01245439|182953826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 8||||<0.001
91537449|NCT01245439|182953826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 3||||<0.001
91537450|NCT01245439|182953826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 3 to Visit 4||||<0.001
91537451|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 4 to Visit 5||||0.001
91537452|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 5 to Visit 6||||0.084
91537453|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 6 to Visit 7||||0.272
91537454|NCT01245439|182953826|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 7 to Visit 8||||0.020
91537455|NCT01245439|182953826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 8||||<0.001
91537456|NCT01245439|182953827|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
91537457|NCT01245439|182953827|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||<0.001
91537458|NCT01245439|182953827|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.254
91537459|NCT01245439|182953827|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.138
91537460|NCT01245439|182953827|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.002
91763098|NCT04607837|183416716|SUPERIORITY||Risk Difference (RD)|8.24||||0.2302|TWO_SIDED|95.0|-5.22|21.71|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.71|-5.22|0.2302
91537461|NCT01245439|182953827|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.104
91537462|NCT01245439|182953827|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 8||||<0.001
91537463|NCT01245439|182953828|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
91763099|NCT04607837|183416717|SUPERIORITY||Risk Difference (RD)|7.12||||0.3339|TWO_SIDED|95.0|-7.32|21.55|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||21.55|-7.32|0.3339
91763100|NCT04607837|183416718|SUPERIORITY||Risk Difference (RD)|0.68||||0.9141|TWO_SIDED|95.0|-11.76|13.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||13.13|-11.76|0.9141
91537464|NCT01245439|182953828|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||0.002
91537465|NCT01245439|182953828|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.078
91537466|NCT01245439|182953828|SUPERIORITY_OR_OTHER|||||||0.349|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.349
91537467|NCT01245439|182953828|SUPERIORITY_OR_OTHER|||||||0.722|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.722
91537468|NCT01245439|182953828|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.224
91537469|NCT01972152|182953838|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis.||||||0.24
91537470|NCT01972152|182953839|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.34
91537471|NCT01972152|182953839|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.01
91537472|NCT01972152|182953840|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
91537473|NCT01972152|182953841|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
91537474|NCT01972152|182953842|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
91537475|NCT01972152|182953842|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
91537476|NCT01972152|182953843|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||0.16
91537477|NCT01972152|182953844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
91537478|NCT01972152|182953844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
91537479|NCT01972152|182953845|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
91537480|NCT01972152|182953845|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||<0.001
91537481|NCT01972152|182953846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91537482|NCT01972152|182953846|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91537483|NCT00972504|182953847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.2|-0.1||||||||-0.1|-1.2|
91537484|NCT00972504|182953847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.8|-0.8||||||||-0.8|-1.8|
91537485|NCT00972504|182953847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.9|-0.8||||||||-0.8|-1.9|
91537486|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.0|0.3|||||Comparison of Nasal Blockage between Placebo and GSK1004723 1000 µg once daily.|||0.3|-0.0|
91537487|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily.|||-0.1|-0.4|
91537488|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily.|||-0.1|-0.4|
91537489|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
91537490|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.2|||||Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.6|
91537491|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.3|||||Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily.|||-0.3|-0.6|
91537492|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
91537493|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.5|
91537494|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily.|||-0.2|-0.5|
91537495|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily.|||-0.2|-0.5|
91537496|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.2|||||Comparison of Sneezing between Placebo and GSK835726 10mg once daily.|||-0.2|-0.4|
91537497|NCT00972504|182953848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and Cetirizine 10mg once daily.|||-0.2|-0.5|
91537498|NCT00972504|182953849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.041|STANDARD_ERROR_OF_MEAN|0.4194|||TWO_SIDED|95.0|-1.87|-0.212||||||||-0.212|-1.870|
91537499|NCT00972504|182953849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.4172|||TWO_SIDED|95.0|-2.584|-0.936||||||||-0.936|-2.584|
91537500|NCT00972504|182953849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.792|STANDARD_ERROR_OF_MEAN|0.4224|||TWO_SIDED|95.0|-3.626|-1.957||||||||-1.957|-3.626|
91537501|NCT00972504|182953850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|-0.28|0.93||||||||0.93|-0.28|
91763101|NCT04607837|183416719|SUPERIORITY||Risk Difference (RD)|9.56||||0.1089|TWO_SIDED|95.0|-2.13|21.25|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.25|-2.13|0.1089
91537502|NCT00972504|182953850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-1.65|-0.45||||||||-0.45|-1.65|
91537503|NCT00972504|182953850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.308||||95.0|-1.68|-0.46||||||||-0.46|-1.68|
91537504|NCT04495634|182953889|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.|||||<|0.0001|||||||ANOVA|||||||<0.0001
91537505|NCT04495634|182953890|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.41|||||||ANOVA|||||||0.41
91537506|NCT04495634|182953891|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
91537507|NCT04495634|182953892|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
91537508|NCT03028363|182953904|OTHER|||||||0.343|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.3430
91537509|NCT03028363|182953905|OTHER|||||||0.126|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.1260
91537510|NCT03028363|182953906|OTHER|||||||0.5247|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.5247
91537511|NCT00768651|182953913|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.||||< 0.05
91537512|NCT04771273|182953938|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.47||||0.001|TWO_SIDED|95.0|1.66|7.25||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||7.25|1.66|0.0010
91537513|NCT04771273|182953938|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.52|||<|0.0001|TWO_SIDED|95.0|4.35|20.85||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||20.85|4.35|<0.0001
91537514|NCT04771273|182953938|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|7.07|||<|0.0001|TWO_SIDED|95.0|3.1|16.16||The p-value reported is considered nominal.|Regression, Logistic|||The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||16.16|3.10|<.0001
91537515|NCT04771273|182953938|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537516|NCT04771273|182953938|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537517|NCT04771273|182953938|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0008|||||||MCP-Mod exponential -2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0008
91763102|NCT04607837|183416720|SUPERIORITY||Risk Difference (RD)|11.19||||0.0104|TWO_SIDED|95.0|2.63|19.75|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.75|2.63|0.0104
91763103|NCT04607837|183416721|SUPERIORITY||Risk Difference (RD)|-1.07||||0.9203|TWO_SIDED|95.0|-22.06|19.92|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.92|-22.06|0.9203
91537518|NCT04771273|182953938|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537519|NCT04771273|182953938|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537520|NCT04771273|182953938|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537521|NCT04771273|182953939|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|2.46|12.28||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||12.28|2.46|<.0001
91537522|NCT04771273|182953939|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.14|||<|0.0001|TWO_SIDED|95.0|4.49|22.87||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||22.87|4.49|<.0001
91537523|NCT04771273|182953939|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|4.87||||0.0001|TWO_SIDED|95.0|2.18|10.91||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||10.91|2.18|0.0001
91537524|NCT04771273|182953939|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0001|||||||MCPMod linear model fit|linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0001
91537525|NCT04771273|182953939|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0115|||||||MCPMod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0115
91763104|NCT04607837|183416722|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
91763105|NCT04607837|183416723|SUPERIORITY||Risk Difference (RD)|-1.71||||0.9272|TWO_SIDED|95.0|-38.31|34.9|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||34.90|-38.31|0.9272
91763106|NCT04607837|183416724|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
91763107|NCT04607837|183416725|SUPERIORITY||Risk Difference (RD)|18.64||||0.0151|TWO_SIDED|95.0|3.61|33.67|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||33.67|3.61|0.0151
91763108|NCT04607837|183416726|SUPERIORITY||Risk Difference (RD)|5.96||||0.4419|TWO_SIDED|95.0|-9.22|21.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.13|-9.22|0.4419
91537526|NCT04771273|182953939|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.2204|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.2204
91537527|NCT04771273|182953939|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537528|NCT04771273|182953939|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537529|NCT04771273|182953939|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537530|NCT04771273|182953940|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.07|||<|0.0001|TWO_SIDED|95.0|2.47|10.4||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||10.40|2.47|<.0001
91763109|NCT04607837|183416727|SUPERIORITY||Risk Difference (RD)|23.33||||0.0007|TWO_SIDED|95.0|9.78|36.89|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||36.89|9.78|0.0007
91763110|NCT04607837|183416728|SUPERIORITY||Risk Difference (RD)|14.99||||0.0128|TWO_SIDED|95.0|3.19|26.79|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.79|3.19|0.0128
91763111|NCT04607837|183416729|SUPERIORITY||Risk Difference (RD)|10.24||||0.1492|TWO_SIDED|95.0|-3.67|24.14|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.14|-3.67|0.1492
91763112|NCT04607837|183416730|SUPERIORITY||Risk Difference (RD)|0.18||||0.9774|TWO_SIDED|95.0|-12.18|12.53|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||12.53|-12.18|0.9774
91763113|NCT04607837|183416731|SUPERIORITY||Risk Difference (RD)|22.83||||0.0011|TWO_SIDED|95.0|9.17|36.49|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||36.49|9.17|0.0011
91763114|NCT04607837|183416732|SUPERIORITY||Risk Difference (RD)|10.8||||0.1513|TWO_SIDED|95.0|-3.95|25.56|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||25.56|-3.95|0.1513
91763115|NCT04607837|183416733|SUPERIORITY||Risk Difference (RD)|10.07||||0.1823|TWO_SIDED|95.0|-4.73|24.87|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.87|-4.73|0.1823
91763116|NCT05236257|183416754|OTHER||Hazard Ratio (HR)|0.21||||0.0058|TWO_SIDED|95.0|0.07|0.63|||Cox Proportional Hazards model|Unweighted||||0.63|0.07|0.0058
91763117|NCT05236257|183416754|OTHER|||||||0.0023|||||||Log Rank|Unweighted||||||0.0023
91763118|NCT05236257|183416755|OTHER||Hazard Ratio (HR)|0.23||||0.0703|TWO_SIDED|95.0|0.05|1.13|||Cox Proportional Hazards model|Unweighted||||1.13|0.05|0.0703
91763119|NCT05236257|183416755|OTHER|||||||0.0486|||||||Log Rank|Unweighted||||||0.0486
91537531|NCT04771273|182953940|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.36|20.51||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||20.51|4.36|<.0001
91537532|NCT04771273|182953940|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|16.09|||<|0.0001|TWO_SIDED|95.0|6.69|38.73||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||38.73|6.69|<.0001
91537533|NCT04771273|182953940|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537534|NCT04771273|182953940|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537535|NCT04771273|182953940|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537536|NCT04771273|182953940|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91763120|NCT05236257|183416756|OTHER||Hazard Ratio (HR)|0.23||||0.696|TWO_SIDED|95.0|0.05|1.12|||Cox Proportional Hazards model|Unweighted||||1.12|0.05|0.696
91763121|NCT05236257|183416756|OTHER|||||||0.0476|||||||Log Rank|Unweighted||||||0.0476
91763122|NCT05236257|183416758|OTHER||Hazard Ratio (HR)|0.79||||0.5713|TWO_SIDED|95.0|0.36|1.77|||Cox Proportional Hazards model|Unweighted||||1.77|0.36|0.5713
91763123|NCT05236257|183416758|OTHER|||||||0.5695|||||||Log Rank|Unweighted||||||0.5695
91763124|NCT05236257|183416759|OTHER||Hazard Ratio (HR)|0.32||||0.32|TWO_SIDED|95.0|0.03|3.06|||Cox Proportional Hazards model|Unweighted||||3.06|0.03|0.3200
91763125|NCT05236257|183416759|OTHER|||||||0.294|||||||Log Rank|Unweighted||||||0.2940
91763126|NCT05870865|183416761|SUPERIORITY||Mean Difference (Final Values)|4.28||||0.5483|TWO_SIDED||||||Mixed Models Analysis|||||||0.5483
91763127|NCT05870865|183416761|SUPERIORITY||Mean Difference (Final Values)|-5.89||||0.4123|TWO_SIDED||||||Mixed Models Analysis|||||||0.4123
91763128|NCT05870865|183416761|SUPERIORITY||Mean Difference (Final Values)|1.66||||0.8177|TWO_SIDED||||||Mixed Models Analysis|||||||0.8177
91763129|NCT05870865|183416762|SUPERIORITY||Odds Ratio (OR)|0.66||||0.4601|TWO_SIDED||||||Fisher Exact|||||||0.4601
91763130|NCT05870865|183416762|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0804|TWO_SIDED||||||Fisher Exact|||||||0.0804
91763131|NCT05870865|183416762|SUPERIORITY||Odds Ratio (OR)|1.06|||>|0.9999|TWO_SIDED||||||Fisher Exact|||||||>0.9999
91763132|NCT05870865|183416763|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.2146|TWO_SIDED||||||Mixed Models Analysis|||||||0.2146
91763133|NCT05870865|183416763|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8851|TWO_SIDED||||||Mixed Models Analysis|||||||0.8851
91763134|NCT05870865|183416763|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.1835|TWO_SIDED||||||Mixed Models Analysis|||||||0.1835
91537537|NCT04771273|182953940|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91763135|NCT05870865|183416764|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.7982|TWO_SIDED||||||Mixed Models Analysis|||||||0.7982
91763136|NCT05870865|183416764|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.564|TWO_SIDED||||||Mixed Models Analysis|||||||0.5640
91763137|NCT05870865|183416764|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2939|TWO_SIDED||||||Mixed Models Analysis|||||||0.2939
91763138|NCT05870865|183416765|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.3579|TWO_SIDED||||||Mixed Models Analysis|||||||0.3579
91763139|NCT05870865|183416765|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.3466|TWO_SIDED||||||Mixed Models Analysis|||||||0.3466
91763140|NCT05870865|183416765|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9527|TWO_SIDED||||||Mixed Models Analysis|||||||0.9527
91763141|NCT03828019|183416773|SUPERIORITY||Odds Ratio (OR)|1.86||||0.029|TWO_SIDED|95.0|1.06|3.25|||Regression, Logistic|Adjusted for the 2 stratification variables (initial prednisone dose and immunosuppression use at baseline).|Estimated parameter is the Odds Ratios (ADA/CID). Result greater than 1 indicates ADA is superior in achieving successful corticosteroid sparing|The sample size estimation: Adalimumab was estimated to be successful in 75% of patients. The overall success rate with conventional immunosuppression was estimated to be 51%. A sample size of 222 (111 per treatment group) provided 90% power to detect a difference in cumulative percent of 75% versus 51%||3.25|1.06|0.029
91763142|NCT03828019|183416774|SUPERIORITY||Odds Ratio (OR)|1.91||||0.072|TWO_SIDED|95.0|0.94|3.86|||Regression, Logistic||Odds ADA/ Odds CID|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.86|0.94|0.072
91763143|NCT03828019|183416775|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.67|3.46|||Regression, Logistic||Odds ratio is ADA/CID where value greater than 1 indicates ADA is superior for corticosteroid (prednisone) discontinuation|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.46|0.67|0.30
91763144|NCT03828019|183416776|SUPERIORITY||Odds Ratio (OR)|1.85||||0.028|TWO_SIDED|95.0|1.06|3.19|||Regression, Logistic||Odds ADA/ Odds CID where value greater than 1 indicate greater corticosteroid sparing success in the ADA group|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.19|1.06|0.028
91763145|NCT03828019|183416777|SUPERIORITY||Ratio of rate of steroid (mg/day ADA/CID|0.86||||0.061|TWO_SIDED|95.0|0.73|1.01|||negative binomial model||Number greater than 1 would indicate rate of steroid use is higher in participants assigned to ADA|||1.01|0.73|0.061
91763146|NCT03828019|183416778|SUPERIORITY||Difference in mean change from BL|0.4||||0.77|TWO_SIDED|95.0|-2.3|3.1|||Mixed Models Analysis|||Mixed effects models were used with a linear link. The fixed effects included initial steroid dose and immunosuppression use at baseline. Additional visit indicators (months 1-12) and corresponding treatment by visit interaction terms. An unstructured correlation was used to model repeated measurements by eye . A person-level random intercept was added to account for between-eye correlations.||3.1|-2.3|0.77
91763147|NCT03828019|183416779|SUPERIORITY||Ratio of odds ratios|0.55||||0.028|TWO_SIDED|95.0|0.31|0.94|||Regression, Logistic||estimate is the ratio of odds ratios - OR ADA / OR CID. Value less than 1 indicates ADA is better at reducing macular edema.|Mixed effects models with a log link were used to assess treatment differences . The outcome measure was the odds ratio of having macular edema (OCT central subfield thickness \> 300 um) at 12 months compared to baseline (BL). The treatment effect was the ratio of Odds ratios (ADA/CID) at 12 months. Values less than one indicate improvement in macular edema for the ADA treatment group relative to the CID group. Decrease in subfield thickness is good||0.94|0.31|0.028
91763148|NCT03828019|183416780|SUPERIORITY||Risk Ratio (RR)|1.1||||0.76|TWO_SIDED|95.0|0.61|1.98|||negative binomial model|||||1.98|0.61|0.76
91763149|NCT03828019|183416781|SUPERIORITY||Cox Proportional Hazard|0.16||||0.014|TWO_SIDED|95.0|0.04|0.7|||Regression, Cox|||. Kaplan Meier techniques and Cox proportional hazards models were used to evaluate time to event outcomes||0.70|0.04|0.014
91763150|NCT03828019|183416782|SUPERIORITY||Cox Proportional Hazard|0.89||||0.74|TWO_SIDED|95.0|0.43|1.82|||Regression, Cox|||||1.82|0.43|0.74
91763151|NCT03828019|183416783|SUPERIORITY||Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.43|1.34|||Ratio of odds ratios||Treatment comparison is the ratio of the odds ratios for each treatment group (ADA/CID) at 12 months. Values greater than one indicate greater improvement in health for the ADA treatment group relative to the CID group.|||1.34|0.43|0.35
91763152|NCT03828019|183416784|SUPERIORITY||Mean Difference (Net)|1.39||||0.24|TWO_SIDED|95.0|-0.95|3.73|||Mixed Models Analysis|||||3.73|-0.95|0.24
91763153|NCT03828019|183416785|SUPERIORITY||Mean Difference (Net)|0.59||||0.7|TWO_SIDED|95.0|-2.43|3.61|||Mixed Models Analysis|||||3.61|-2.43|0.70
91763154|NCT03828019|183416786|SUPERIORITY||Mean Difference (Net)|1.6||||0.28|TWO_SIDED|95.0|-1.4|4.6|||Mixed Models Analysis|||||4.6|-1.4|0.28
91537538|NCT04771273|182953940|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537539|NCT04771273|182953941|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.39|||<|0.0001|TWO_SIDED|95.0|4.6|23.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||23.45|4.60|<.0001
91537540|NCT04771273|182953941|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|12.06|||<|0.0001|TWO_SIDED|95.0|5.3|27.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||27.45|5.30|<.0001
91537541|NCT04771273|182953941|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.5||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||18.50|3.66|<.0001
91537542|NCT04771273|182953941|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537543|NCT04771273|182953941|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0031|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0031
91537544|NCT04771273|182953941|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0925|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0925
91537545|NCT04771273|182953941|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91763155|NCT03828019|183416787|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.009|TWO_SIDED|95.0|0.07|0.67|||Regression, Cox|||||0.67|0.07|0.009
91763156|NCT02211456|183416827|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.05|TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||The data derived from this study was complex multi-level data with errors due to patient-level and intra-patient repeat factors. Accordingly, we used generalized multi-level modelling (GLMM) with random effects.||6.3|1|<0.05
91763157|NCT02910102|183416828|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.3565|TWO_SIDED|95.0|-6.04|2.23||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||2.23|-6.04|0.3565
91763158|NCT02910102|183416829|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.922|TWO_SIDED|95.0|-3.73|3.38||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||3.38|-3.73|0.9220
91537546|NCT04771273|182953941|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537547|NCT04771273|182953941|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
91537548|NCT04771273|182953942|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-8.59|||<|0.0001|TWO_SIDED|95.0|-10.59|-6.6||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-6.60|-10.59|<.0001
91537549|NCT04771273|182953942|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.91|||<|0.0001|TWO_SIDED|95.0|-12.96|-8.86||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.86|-12.96|<.0001
91537550|NCT04771273|182953942|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-11.07|||<|0.0001|TWO_SIDED|95.0|-13.23|-8.92||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.92|-13.23|<.0001
91537551|NCT04771273|182953943|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-9.12|||<|0.0001|TWO_SIDED|95.0|-11.21|-7.03||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-7.03|-11.21|<.0001
91537552|NCT04771273|182953943|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.79|||<|0.0001|TWO_SIDED|95.0|-12.85|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-12.85|<.0001
91537553|NCT04771273|182953943|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.86|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-13.00|<.0001
91537554|NCT04771273|182953944|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-43.64|||<|0.0001|TWO_SIDED|95.0|-53.49|-33.79||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-33.79|-53.49|<.0001
91763159|NCT02863328|183416838|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
91537555|NCT04771273|182953944|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.52|||<|0.0001|TWO_SIDED|95.0|-65.61|-45.42||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.42|-65.61|<.0001
91537556|NCT04771273|182953944|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-57.02|||<|0.0001|TWO_SIDED|95.0|-67.66|-46.39||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-46.39|-67.66|<.0001
91763160|NCT02863328|183416838|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
91763161|NCT02863328|183416838|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
91763162|NCT02863328|183416838|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
91763163|NCT02863328|183416839|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.1|||=|0.7593|TWO_SIDED|95.0|-0.7|0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.7|= 0.7593
91763164|NCT02863328|183416839|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.4|||=|0.1358|TWO_SIDED|95.0|-1.0|0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.1|-1.0|= 0.1358
91763165|NCT02863328|183416867|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.85||||0.3552|TWO_SIDED|95.0|0.6|1.2||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.20|0.60|0.3552
91763166|NCT02863328|183416868|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19||Unadjusted two-sided p-value for test of no difference from 1.|Cox proportional hazards model||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.19|0.47|0.2250
91763167|NCT00429169|183416913|SUPERIORITY_OR_OTHER||regression coefficient|-0.29||||0.03|TWO_SIDED|95.0|-0.57|-0.023||The p-value applies to the interaction term of Treatment X Baseline Suicidal Ideation severity.|Mixed Models Analysis|||Generalized least squares model of Scale for Suicidal Ideation score during 8-week acute treatment of major depressive disorder.||-0.023|-0.57|0.03
91763168|NCT02936635|183416920|SUPERIORITY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.619||0.2821|TWO_SIDED|95.0|-11.035|3.23|||Mixed Models Analysis|||||3.23|-11.035|0.2821
91763169|NCT02936635|183416921|SUPERIORITY||Median Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|4.242||0.2118|TWO_SIDED|95.0|-13.711|3.067|||Mixed Models Analysis|||||3.067|-13.711|0.2118
91763170|NCT02936635|183416922|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|1.205||0.6354|TWO_SIDED|95.0|-2.946|1.801|||Mixed Models Analysis|||||1.801|-2.946|0.6354
91763171|NCT02936635|183416923|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.509||0.8887|TWO_SIDED|95.0|-3.186|2.763|||Mixed Models Analysis|||||2.763|-3.186|0.8887
91763172|NCT03652181|183416953|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean QSM||||||0.033|||||||t-test, 2 sided|||||||0.033
91763173|NCT03652181|183416954|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean DCEQP||||||0.3459|||||||t-test, 2 sided|||||||0.3459
91763174|NCT03652181|183416955|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 numbers||||||1|||||||Chi-squared|||||||1.0
91763175|NCT02451917|183416976|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.||||||0.00045||||||The intention-to-treat population consisted of all randomized participants.|ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.||||0.00045
91763176|NCT02451917|183416977|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.|number of total events per patient|0.0||||0.35|TWO_SIDED|||||Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks||||0.35
91763177|NCT02451917|183416977|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|number of nocturnal events per patient|0.0||||0.047|TWO_SIDED|||||Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.047
91763178|NCT02451917|183416978|NON_INFERIORITY_OR_EQUIVALENCE|t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.|||||<|0.05|||||||t-test, 1 sided|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||<0.05
91763179|NCT02451917|183416979|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.668|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.668
91763180|NCT02451917|183416980|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
91537557|NCT04771273|182953945|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-46.49|||<|0.0001|TWO_SIDED|95.0|-56.74|-36.25||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-36.25|-56.74|<.0001
91537558|NCT04771273|182953945|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.11|||<|0.0001|TWO_SIDED|95.0|-65.25|-44.98||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-44.98|-65.25|<.0001
91537559|NCT04771273|182953945|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-56.26|||<|0.0001|TWO_SIDED|95.0|-66.76|-45.77||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.77|-66.76|<.0001
91763181|NCT02451917|183416981|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
91763182|NCT02451917|183416982|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.994|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.994
91763183|NCT03726489|183416989|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.2|||<|0.001|TWO_SIDED|95.0|0.8|13.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||13.5|0.8|<0.001
91763184|NCT03726489|183416989|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|-5.4|13.8||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||13.8|-5.4|<0.001
91763185|NCT03726489|183416989|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.4|||<|0.001|TWO_SIDED|95.0|-2.2|17.0||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||17.0|-2.2|<0.001
91763186|NCT03726489|183416989|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|18.7|||<|0.001|TWO_SIDED|95.0|0.8|36.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||36.6|0.8|<0.001
91763187|NCT03726489|183416989|OTHER|HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.||||||0.347||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.347
91763188|NCT03726489|183416990|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|18.6|||<|0.001|TWO_SIDED|95.0|11.8|25.3||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||25.3|11.8|<0.001
91763189|NCT03726489|183416990|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.2|||<|0.001|TWO_SIDED|95.0|11.0|31.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||31.5|11.0|<0.001
91763190|NCT03726489|183416990|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.5|||<|0.001|TWO_SIDED|95.0|6.4|26.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||26.6|6.4|<0.001
91513903|NCT03779841|182899893|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9814|TWO_SIDED|95.0|0.5|1.96|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.96|0.50|0.9814
91513904|NCT03779841|182899893|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9715|TWO_SIDED|95.0|0.5|1.97|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.97|0.50|0.9715
91513905|NCT03779841|182899894|SUPERIORITY|||||||0.1281|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.1281
91513906|NCT03779841|182899894|SUPERIORITY|||||||0.882|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8820
91513907|NCT03779841|182899895|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1623|TWO_SIDED|95.0|0.57|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.57|0.1623
91513908|NCT03779841|182899895|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7776|TWO_SIDED|95.0|0.78|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.78|0.7776
91513909|NCT03779841|182899896|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1603|TWO_SIDED|95.0|0.56|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.56|0.1603
91513910|NCT03779841|182899896|SUPERIORITY||Risk Ratio (RR)|1.06||||0.6706|TWO_SIDED|95.0|0.8|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.80|0.6706
91513911|NCT03779841|182899897|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1583|TWO_SIDED|95.0|0.55|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.55|0.1583
91513912|NCT03779841|182899897|SUPERIORITY||Risk Ratio (RR)|1.07||||0.6694|TWO_SIDED|95.0|0.8|1.43|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.43|0.80|0.6694
91513913|NCT03779841|182899898|SUPERIORITY||Risk Ratio (RR)|0.81||||0.2578|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2578
91513914|NCT03779841|182899898|SUPERIORITY||Risk Ratio (RR)|1.05||||0.7526|TWO_SIDED|95.0|0.76|1.47|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.47|0.76|0.7526
91513915|NCT03779841|182899899|SUPERIORITY||Risk Ratio (RR)|0.8||||0.2549|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2549
91513916|NCT03779841|182899899|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8544|TWO_SIDED|95.0|0.73|1.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.45|0.73|0.8544
91513917|NCT03779841|182899900|SUPERIORITY||Risk Ratio (RR)|0.74||||0.1718|TWO_SIDED|95.0|0.48|1.14|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.14|0.48|0.1718
91513918|NCT03779841|182899900|SUPERIORITY||Risk Ratio (RR)|0.83||||0.3801|TWO_SIDED|95.0|0.54|1.27|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.27|0.54|0.3801
91513919|NCT03779841|182899901|SUPERIORITY||Risk Ratio (RR)|0.87||||0.5531|TWO_SIDED|95.0|0.54|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.54|0.5531
91513920|NCT03779841|182899901|SUPERIORITY||Risk Ratio (RR)|0.82||||0.4213|TWO_SIDED|95.0|0.51|1.33|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.33|0.51|0.4213
91537560|NCT04771273|182953946|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|1.61||||0.1894|TWO_SIDED|95.0|0.79|3.26||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||3.26|0.79|0.1894
91537561|NCT04771273|182953946|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.0||||0.0685|TWO_SIDED|95.0|0.95|4.2||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.20|0.95|0.0685
91763191|NCT03726489|183416990|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|16.1||||0.001|TWO_SIDED|95.0|-3.7|35.9||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.9|-3.7|0.001
91763192|NCT03726489|183416990|OTHER|||||||0.873||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.873
91763193|NCT03726489|183416991|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.0001|TWO_SIDED|95.0|7.1|10.4||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||10.4|7.1|<0.0001
91763194|NCT03726489|183416991|SUPERIORITY||Mean Difference (Final Values)|9.38|||<|0.0001|TWO_SIDED|95.0|7.05|11.71||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||11.71|7.05|<0.0001
91763195|NCT03726489|183416991|SUPERIORITY||Mean Difference (Final Values)|8.48|||<|0.0001|TWO_SIDED|95.0|5.82|11.14||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||11.14|5.82|<0.0001
91763196|NCT03726489|183416991|SUPERIORITY||Mean Difference (Final Values)|6.82||||0.0213|TWO_SIDED|95.0|1.06|12.58||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||12.58|1.06|0.0213
91537562|NCT04771273|182953946|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.37||||0.0028|TWO_SIDED|95.0|1.52|7.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||7.45|1.52|0.0028
91537563|NCT04771273|182953947|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.02||||0.0663|TWO_SIDED|95.0|0.95|4.27||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.27|0.95|0.0663
91537564|NCT04771273|182953947|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.01||||0.0672|TWO_SIDED|95.0|0.95|4.23||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.23|0.95|0.0672
91537565|NCT04771273|182953947|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.11||||0.0512|TWO_SIDED|95.0|1.0|4.46||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.46|1.00|0.0512
91537566|NCT01543685|182953991|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|441.8|STANDARD_ERROR_OF_MEAN|129.6|<|0.001|TWO_SIDED|95.0|187.1|696.5|||ANCOVA|||||696.5|187.1|<0.001
91537567|NCT01543685|182953991|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|260.2|STANDARD_ERROR_OF_MEAN|130.3||0.046|TWO_SIDED|95.0|4.1|516.3|||ANCOVA|||||516.3|4.1|0.046
91537568|NCT01543685|182953991|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|312.7|STANDARD_ERROR_OF_MEAN|130.4||0.017|TWO_SIDED|95.0|56.6|568.9|||ANCOVA|||||568.9|56.6|0.017
91537569|NCT01543685|182953991|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|211.6|STANDARD_ERROR_OF_MEAN|129.6||0.103|TWO_SIDED|95.0|-43.1|466.2|||ANCOVA|||||466.2|-43.1|0.103
91537570|NCT01543685|182953992|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|||||||0.013
91763197|NCT03726489|183416992|SUPERIORITY||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|95.0|10.4|18.7||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||18.7|10.4|<0.0001
91537571|NCT01543685|182953992|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
91763198|NCT03726489|183416992|SUPERIORITY||Mean Difference (Final Values)|11.47|||<|0.0001|TWO_SIDED|95.0|6.93|16.01||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||16.01|6.93|<0.0001
91537572|NCT01543685|182953992|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||t-test, 2 sided|||||||0.211
91537573|NCT01543685|182953992|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||t-test, 2 sided|||||||0.098
91537574|NCT01543685|182953993|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
91537575|NCT01543685|182953993|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91537576|NCT01543685|182953993|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
91537577|NCT01543685|182953993|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
91537578|NCT01543685|182953994|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91763199|NCT03726489|183416992|SUPERIORITY||Mean Difference (Final Values)|13.87|||<|0.0001|TWO_SIDED|95.0|7.77|19.98||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||19.98|7.77|<0.0001
91537579|NCT01543685|182953994|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91537580|NCT01543685|182953994|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
91537581|NCT01543685|182953994|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
91537582|NCT01543685|182953995|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91537583|NCT01543685|182953995|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
91537584|NCT01543685|182953995|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||t-test, 2 sided|||||||0.146
91537585|NCT01543685|182953995|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|||||||0.071
91537586|NCT01543685|182953996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91537587|NCT01543685|182953996|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
91537588|NCT01543685|182953996|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.010
91537589|NCT01543685|182953996|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
91537590|NCT01543685|182953997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91537591|NCT01543685|182953997|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
91537592|NCT01543685|182953997|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
91537593|NCT01543685|182953997|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
91537594|NCT01543685|182953998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91537595|NCT01543685|182953998|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.020
91537596|NCT01543685|182953998|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
91537597|NCT01543685|182953998|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
91537598|NCT00556543|182954006|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation performed.||||||0.19||95.0|||||Fisher Exact|||Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.||||0.190
91537599|NCT01838551|182954017|SUPERIORITY|Under the null hypothesis of at most 20% UFC responders, 90 subjects in the ITT population would provide 90% power, with two-sided type 1 error of 0.05, assuming an observed response of 35%.||||||0.0154||||||One-sided p-value is based on a null hypothesis that true response proportion is ≤ 0.20.|Mixed Models Analysis|The Generalized Linear Model described above was used to generate the p-value.||The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented. Supportive to the 95% CI, the p-value corresponding to the null hypothesis that the response rate is ≤ 20% is presented (1-sided test).||||0.0154
91537600|NCT00038103|182954023|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|49.0||||||95.0|34.4|63.7|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||63.7|34.4|
91537601|NCT00038103|182954023|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|47.1||||||95.0|32.9|61.5|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||61.5|32.9|
91537602|NCT00038103|182954024|SUPERIORITY_OR_OTHER||Objective Response Rate|22.4||||||95.0|11.8|36.6|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||36.6|11.8|
91537603|NCT00038103|182954024|SUPERIORITY_OR_OTHER||Objective Response Rate|23.5||||||95.0|12.8|37.5|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||37.5|12.8|
91537604|NCT01391013|182954031|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.08
91537605|NCT01391013|182954032|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.88
91537606|NCT01391013|182954033|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.31
91537607|NCT01391013|182954034|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.37
91537608|NCT01391013|182954035|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
91537609|NCT01391013|182954036|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.02
91537610|NCT01391013|182954037|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.12
91537611|NCT01391013|182954038|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.71
91537612|NCT01391013|182954039|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.83
91537613|NCT01391013|182954040|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
91537614|NCT01391013|182954041|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.76
91537615|NCT01391013|182954042|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.56
91537616|NCT01391013|182954043|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.11
91537617|NCT01391013|182954044|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.18
91537618|NCT01391013|182954045|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.03
91537619|NCT01391013|182954046|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.04
91537620|NCT01304147|182954115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|3.9|11.3|||Paired t-test, 2 sided|||within-subject crossover design||11.3|3.9|<0.001
91537621|NCT01942707|182954117|SUPERIORITY||Mean Difference (Final Values)|179.0|STANDARD_DEVIATION|222.0||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
91537622|NCT01942707|182954118|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.9||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.012
91537623|NCT01942707|182954119|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_DEVIATION|40.7||0.809|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.809
91537624|NCT00831272|182954138|SUPERIORITY_OR_OTHER|||||||0.32|||||||Generalized Estimating Equation|||||||0.32
91513921|NCT03779841|182899902|SUPERIORITY||Risk Ratio (RR)|0.92||||0.804|TWO_SIDED|95.0|0.49|1.73|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.73|0.49|0.8040
91537625|NCT00864682|182954146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Kruskal-Wallis|||Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.||||<0.0001
91537626|NCT00864682|182954147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.008||95.0|||||Chi-squared|Fisher's exact test after chi-squared||||||<0.008
91537627|NCT04897737|182954175|SUPERIORITY||Risk Ratio (RR)|1.83|||<|0.001|TWO_SIDED|95.0|1.19|2.82|||Mixed Models Analysis|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and risk differences (RDs) with 95% CIs.||2.82|1.19|<0.001
91537628|NCT04897737|182954176|SUPERIORITY||Risk Ratio (RR)|3.89|||<|0.001|TWO_SIDED|95.0|2.08|7.27|||Regression, Linear|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and 95% CIs.|RD=49.1% (95% CI=32.8, 65.3), p\<0.001|7.27|2.08|<0.001
91537629|NCT04059237|182954179|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
91537630|NCT04059237|182954180|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<.001
91537631|NCT04059237|182954181|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
91537632|NCT04059237|182954182|OTHER|||||||0.1||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.10
91537633|NCT04059237|182954183|OTHER|||||||0.01||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||.01
91537634|NCT04059237|182954184|OTHER|||||||0.59||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.59
91513922|NCT03779841|182899902|SUPERIORITY||Risk Ratio (RR)|1.1||||0.7573|TWO_SIDED|95.0|0.61|1.98|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.98|0.61|0.7573
91537635|NCT04059237|182954185|OTHER|||||||0.02||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.02
91537636|NCT04059237|182954186|OTHER|||||||0.52||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.52
91537637|NCT04059237|182954187|OTHER|||||||0.08||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.08
91537638|NCT03525119|182954210|NON_INFERIORITY|As per predefined criteria in protocol the non-inferiority was established only between group 1 and group 3. Non-inferiority of HAV+TDV to HAV was established if the upper bound of the 95% CI was less than 10%.|Seroprotection Rate Difference|-1.68|||||TWO_SIDED|95.0|-8.91|4.28||||||||4.28|-8.91|
91537639|NCT05046132|182954219|OTHER||Mean of Placebo-corrected CHFB|3.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|1.23|6.17||||||"The C-QTc analysis was performed with a non-linear model.~The mean of placebo-corrected CHFB in QTcF at maximum concentration (Cmax) geometric mean of therapeutic dose (3 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods."||6.17|1.23|
91537640|NCT05046132|182954220|OTHER||Mean of Placebo-corrected CHFB|4.67|||||TWO_SIDED|90.0|1.7|7.64||||||The C-QTc analysis was performed with a non-linear model. The mean of placebo-corrected CHFB in QTcF at Cmax geometric mean of therapeutic dose (7 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods.||7.64|1.70|
91537641|NCT05046132|182954221|OTHER||LS Mean|2.5|||||TWO_SIDED|90.0|-0.6|5.6||||||Pre-dose||5.6|-0.6|
91537642|NCT05046132|182954221|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-3.0|3.1||||||0.5 hr Post dose||3.1|-3.0|
91763200|NCT03726489|183416992|SUPERIORITY||Mean Difference (Final Values)|32.84||||0.0127|TWO_SIDED|95.0|7.32|58.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||58.35|7.32|0.0127
91537643|NCT05046132|182954221|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.0||||||1 hr Post dose||3.0|-2.8|
91537644|NCT05046132|182954221|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.8|5.1||||||1.5 hr Post dose||5.1|-1.8|
91537645|NCT05046132|182954221|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.8|4.1||||||2 hr Post dose||4.1|-2.8|
91537646|NCT05046132|182954221|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.9|3.4||||||2.5 hr Post dose||3.4|-2.9|
91537647|NCT05046132|182954221|OTHER||LS Mean|2.2|||||TWO_SIDED|90.0|-1.4|5.7||||||3 hr Post dose||5.7|-1.4|
91537648|NCT05046132|182954221|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.9|2.7||||||4 hr Post dose||2.7|-2.9|
91537649|NCT05046132|182954221|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||5 hr Post dose||2.7|-3.1|
91537650|NCT05046132|182954221|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.8|2.3||||||6 hr Post dose||2.3|-3.8|
91537651|NCT05046132|182954221|OTHER||LS Mean|-2.8|||||TWO_SIDED|90.0|-5.5|-0.1||||||7 hr Post dose||-0.1|-5.5|
91537652|NCT05046132|182954221|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.5|1.3||||||8 hr Post dose||1.3|-4.5|
91537653|NCT05046132|182954221|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.5|3.0||||||9 hr Post dose||3.0|-2.5|
91537654|NCT05046132|182954221|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.3|2.7||||||10 hr Post dose||2.7|-2.3|
91537655|NCT05046132|182954221|OTHER||LS Mean|-3.0|||||TWO_SIDED|90.0|-5.9|-0.1||||||12 hr Post dose||-0.1|-5.9|
91537656|NCT05046132|182954221|OTHER||LS Mean|-2.0|||||TWO_SIDED|90.0|-5.1|1.0||||||16 hr Post dose||1.0|-5.1|
91537657|NCT05046132|182954221|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-1.6|3.8||||||24 hr Post dose||3.8|-1.6|
91537658|NCT05046132|182954221|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.7|4.5||||||Pre-dose||4.5|-1.7|
91537659|NCT05046132|182954221|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.7||||||0.5 hr Post dose||4.7|-1.4|
91537660|NCT05046132|182954221|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||1 hr Post dose||4.8|-1.0|
91537661|NCT05046132|182954221|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.9|6.0||||||1.5 hr Post dose||6.0|-0.9|
91537662|NCT05046132|182954221|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-2.1|4.8||||||2 hr Post dose||4.8|-2.1|
91537663|NCT05046132|182954221|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.9||||||2.5 hr Post dose||4.9|-1.4|
91537664|NCT05046132|182954221|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.9|5.1||||||3 hr Post dose||5.1|-1.9|
91537665|NCT05046132|182954221|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.4|4.2||||||4 hr Post dose||4.2|-1.4|
91537666|NCT05046132|182954221|OTHER||LS Mean|2.7|||||TWO_SIDED|90.0|-0.2|5.7||||||5 hr Post dose||5.7|-0.2|
91537667|NCT05046132|182954221|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|1.4|7.5||||||6 hr Post dose||7.5|1.4|
91537668|NCT05046132|182954221|OTHER||LS Mean|2.8|||||TWO_SIDED|90.0|0.1|5.5||||||7 hr Post dose||5.5|0.1|
91537669|NCT05046132|182954221|OTHER||LS Mean|4.1|||||TWO_SIDED|90.0|1.2|7.0||||||8 hr Post dose||7.0|1.2|
91537670|NCT05046132|182954221|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.8|6.3||||||9 hr Post dose||6.3|0.8|
91537671|NCT05046132|182954221|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|0.8|5.8||||||10 hr Post dose||5.8|0.8|
91537672|NCT05046132|182954221|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.3|5.5||||||12 hr Post dose||5.5|-0.3|
91537673|NCT05046132|182954221|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.7|3.4||||||16 hr Post dose||3.4|-2.7|
91537674|NCT05046132|182954221|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.0|4.4||||||24 hr Post dose||4.4|-1.0|
91537675|NCT05046132|182954222|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.8|3.4||||||Pre dose||3.4|-2.8|
91537676|NCT05046132|182954222|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.3|1.0||||||0.5 hr Post dose||1.0|-5.3|
91537677|NCT05046132|182954222|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.4||||||1 hr Post dose||1.4|-4.7|
91537678|NCT05046132|182954222|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.3|1.0||||||1.5 hr Post dose||1.0|-5.3|
91537679|NCT05046132|182954222|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.3||||||2 hr Post dose||-0.3|-6.3|
91537680|NCT05046132|182954222|OTHER||LS Mean|-1.2|||||TWO_SIDED|90.0|-4.1|1.7||||||2.5 hr Post dose||1.7|-4.1|
91537681|NCT05046132|182954222|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-4.2|1.7||||||3 hr Post dose||1.7|-4.2|
91537682|NCT05046132|182954222|OTHER||LS Mean|-0.6|||||TWO_SIDED|90.0|-3.6|2.5||||||4 hr Post dose||2.5|-3.6|
91537683|NCT05046132|182954222|OTHER||LS Mean|-1.0|||||TWO_SIDED|95.0|-4.1|2.1||||||5 hr Post dose||2.1|-4.1|
91537684|NCT05046132|182954222|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.7|3.5||||||6 hr Post dose||3.5|-2.7|
91537685|NCT05046132|182954222|OTHER||LS Mean|-2.5|||||TWO_SIDED|90.0|-5.5|0.5||||||7 hr Post dose||0.5|-5.5|
91537686|NCT05046132|182954222|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.2|0.8||||||8 hr Post dose||0.8|-5.2|
91537687|NCT05046132|182954222|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-4.3|2.6||||||9 hr Post dose||2.6|-4.3|
91537688|NCT05046132|182954222|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.6|3.2||||||10 hr Post dose||3.2|-3.6|
91537689|NCT05046132|182954222|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.5|1.0||||||12 hr Post dose||1.0|-5.5|
91537690|NCT05046132|182954222|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.4|1.7||||||16 hr Post dose||1.7|-5.4|
91537691|NCT05046132|182954222|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-1.2|6.3||||||24 hr Post dose||6.3|-1.2|
91537692|NCT05046132|182954222|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.1|0.8||||||Pre-dose||0.8|-5.1|
91537693|NCT05046132|182954222|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||0.5 hr Post dose||3.0|-3.1|
91537694|NCT05046132|182954222|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||1 hr Post dose||2.9|-3.0|
91537695|NCT05046132|182954222|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||1.5 hr Post dose||3.0|-3.1|
91537696|NCT05046132|182954222|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.8|2.0||||||2 hr Post dose||2.0|-3.8|
91537697|NCT05046132|182954222|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.5|3.0||||||2.5 hr Post dose||3.0|-2.5|
91537698|NCT05046132|182954222|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-1.9|3.7||||||3 hr Post dose||3.7|-1.9|
91537699|NCT05046132|182954222|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.2|3.7||||||4 hr Post dose||3.7|-2.2|
91537700|NCT05046132|182954222|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.1||||||5 hr Post dose||3.1|-2.8|
91537701|NCT05046132|182954222|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.9|2.0||||||6 hr Post dose||2.0|-3.9|
91537702|NCT05046132|182954222|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||7 hr Post dose||2.7|-3.1|
91537703|NCT05046132|182954222|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.7|3.1||||||8 hr Post dose||3.1|-2.7|
91537704|NCT05046132|182954222|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.7|4.0||||||9 hr Post dose||4.0|-2.7|
91537705|NCT05046132|182954222|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.3|4.1||||||10 hr Post dose||4.1|-2.3|
91763201|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.001|TWO_SIDED|95.0|-1.27|-0.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.35|-1.27|0.001
91537706|NCT05046132|182954222|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.5|2.8||||||12 hr Post dose||2.8|-3.5|
91537707|NCT05046132|182954222|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.8|3.0||||||16 hr Post dose||3.0|-3.8|
91537708|NCT05046132|182954222|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.1|2.0||||||24 hr Post dose||2.0|-5.1|
91537709|NCT05046132|182954223|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|0.1|6.8||||||Pre dose||6.8|0.1|
91763202|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.0158|TWO_SIDED|95.0|-1.51|-0.16||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.16|-1.51|0.0158
91763203|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.013|TWO_SIDED|95.0|-1.58|-0.19||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||-0.19|-1.58|0.0130
91763204|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.591|TWO_SIDED|95.0|-1.94|1.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||1.11|-1.94|0.5910
91763205|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.395|TWO_SIDED|95.0|-0.33|0.82||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes at Week 24||0.82|-0.33|0.395
91763206|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.774|TWO_SIDED|95.0|-0.69|0.93||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II at Week 24||0.93|-0.69|0.774
91763207|NCT03726489|183416993|SUPERIORITY||Median Difference (Final Values)|0.53||||0.242|TWO_SIDED|95.0|-0.36|1.41||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV at Week 24||1.41|-0.36|0.242
91763208|NCT03726489|183416993|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.692|TWO_SIDED|95.0|-2.72|1.83||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI at Week 24||1.83|-2.72|0.692
91763209|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-2.59||||0.1209|TWO_SIDED|95.0|-5.86|0.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation||0.68|-5.86|0.1209
91763210|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-2.13||||0.2581|TWO_SIDED|95.0|-6.0|1.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation||1.75|-6.0|0.2581
91763211|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-3.04||||0.2952|TWO_SIDED|95.0|-8.73|2.65||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation||2.65|-8.73|0.2952
91537710|NCT05046132|182954223|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-3.0|4.6||||||0.5 hr Post dose||4.6|-3.0|
91537711|NCT05046132|182954223|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-4.1|3.9||||||1 hr Post dose||3.9|-4.1|
91537712|NCT05046132|182954223|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.7|4.4||||||1.5 hr Post dose||4.4|-2.7|
91537713|NCT05046132|182954223|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.6|6.6||||||2 hr Post dose||6.6|-0.6|
91537714|NCT05046132|182954223|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|-0.3|7.4||||||2.5 hr Post dose||7.4|-0.3|
91537715|NCT05046132|182954223|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|1.2|8.1||||||3 hr Post dose||8.1|1.2|
91537716|NCT05046132|182954223|OTHER||LS Mean|5.2|||||TWO_SIDED|90.0|1.5|8.9||||||4 hr Post dose||8.9|1.5|
91537717|NCT05046132|182954223|OTHER||LS Mean|2.0|||||TWO_SIDED|90.0|-1.7|5.8||||||5 hr Post dose||5.8|-1.7|
91537718|NCT05046132|182954223|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.6|5.1||||||6 hr Post dose||5.1|-1.6|
91537719|NCT05046132|182954223|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.1|5.7||||||7 hr Post dose||5.7|-1.1|
91537720|NCT05046132|182954223|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.4|6.2||||||8 hr Post dose||6.2|-1.4|
91537721|NCT05046132|182954223|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|0.9|7.8||||||9 hr Post dose||7.8|0.9|
91537722|NCT05046132|182954223|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|0.3|7.4||||||10 hr Post dose||7.4|0.3|
91537723|NCT05046132|182954223|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-4.2|2.7||||||12 hr Post dose||2.7|-4.2|
91537724|NCT05046132|182954223|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.1|7.0||||||16 hr Post dose||7.0|0.1|
91537725|NCT05046132|182954223|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-5.7|2.8||||||24 hr Post dose||2.8|-5.7|
91537726|NCT05046132|182954223|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.0|5.6||||||Pre dose||5.6|-1.0|
91537727|NCT05046132|182954223|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.4|2.2||||||0.5 hr Post dose||2.2|-5.4|
91537728|NCT05046132|182954223|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.8|4.3||||||1 hr Post dose||4.3|-3.8|
91537729|NCT05046132|182954223|OTHER||LS Mean|4.0|||||TWO_SIDED|90.0|0.4|7.6||||||1.5 hr Post dose||7.6|0.4|
91537730|NCT05046132|182954223|OTHER||LS Mean|6.3|||||TWO_SIDED|90.0|2.7|10.0||||||2 hr Post dose||10.0|2.7|
91763212|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-2.61||||0.6324|TWO_SIDED|95.0|-13.12|7.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation||7.89|-13.12|0.6324
91763213|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|0.15||||0.9163|TWO_SIDED|95.0|-2.56|2.85||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation||2.85|-2.56|0.9163
91763214|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|0.31||||0.8551|TWO_SIDED|95.0|-3.03|3.66||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation||3.66|-3.03|0.8551
91763215|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|0.72||||0.7678|TWO_SIDED|95.0|-4.05|5.48||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation||5.48|-4.05|0.7678
91763216|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-3.03||||0.3446|TWO_SIDED|95.0|-8.88|2.82||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation||2.82|-8.88|0.3446
91763217|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-1.26||||0.5716|TWO_SIDED|95.0|-5.64|3.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation at Week 24||3.11|-5.64|0.5716
91763218|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-0.44||||0.8756|TWO_SIDED|95.0|-6.03|5.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation at Week 24||5.14|-6.03|0.8756
91763219|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-2.07||||0.5686|TWO_SIDED|95.0|-9.18|5.04||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation at Week 24||5.04|-9.18|0.5686
91763220|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-1.39||||0.866|TWO_SIDED|95.0|-17.5|14.7||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation at Week 24||14.7|-17.5|0.8660
91763221|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|0.19||||0.8779|TWO_SIDED|95.0|-2.24|2.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation at Week 24||2.62|-2.24|0.8779
91763222|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|0.38||||0.7985|TWO_SIDED|95.0|-2.52|3.28||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation at Week 24||3.28|-2.52|0.7985
91763223|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|0.69||||0.7585|TWO_SIDED|95.0|-3.71|5.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation at Week 24||5.09|-3.71|0.7585
91763224|NCT03726489|183416994|SUPERIORITY||Risk Difference (RD)|-2.78||||0.3422|TWO_SIDED|95.0|-8.15|2.59||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation at Week 24||2.59|-8.15|0.3422
91763225|NCT03726489|183416995|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.094|TWO_SIDED|95.0|-6.95|0.55||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||0.55|-6.95|0.094
91763226|NCT03726489|183416995|SUPERIORITY||Mean Difference (Final Values)|-5.26||||0.0393|TWO_SIDED|95.0|-10.26|-0.26||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.26|-10.26|0.0393
91763227|NCT03726489|183416995|SUPERIORITY||Mean Difference (Final Values)|-3.92||||0.1505|TWO_SIDED|95.0|-9.28|1.44||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||1.44|-9.28|0.1505
91763228|NCT03726489|183416995|SUPERIORITY||Mean Difference (Final Values)|10.42||||0.284|TWO_SIDED|95.0|-9.0|29.84||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||29.84|-9.0|0.2840
91763229|NCT03726489|183416996|OTHER||Mean|19.87|STANDARD_DEVIATION|61.6|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
91763230|NCT03726489|183416996|OTHER||Mean|18.06|STANDARD_DEVIATION|57.04|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
91763231|NCT03726489|183416996|OTHER||Mean|23.46|STANDARD_DEVIATION|70.71|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
91763232|NCT03726489|183416996|OTHER||Mean|9.22|STANDARD_DEVIATION|5.66|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
91763233|NCT03726489|183416997|OTHER||Mean|50.3|STANDARD_DEVIATION|46.7|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
91763234|NCT03726489|183416997|OTHER||Mean|53.19|STANDARD_DEVIATION|50.05|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
91763235|NCT03726489|183416997|OTHER||Mean|49.82|STANDARD_DEVIATION|47.43|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
91763236|NCT03726489|183416997|OTHER||Mean|39.72|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
91537731|NCT05046132|182954223|OTHER||LS Mean|6.4|||||TWO_SIDED|90.0|2.6|10.2||||||2.5 hr Post dose||10.2|2.6|
91537732|NCT05046132|182954223|OTHER||LS Mean|8.5|||||TWO_SIDED|90.0|5.0|12.0||||||3 hr Post dose||12.0|5.0|
91537733|NCT05046132|182954223|OTHER||LS Mean|10.1|||||TWO_SIDED|90.0|6.4|13.8||||||4 hr Post dose||13.8|6.4|
91537734|NCT05046132|182954223|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.1|11.6||||||5 hr Post dose||11.6|4.1|
91537735|NCT05046132|182954223|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.4|11.2||||||6 hr Post dose||11.2|4.4|
91537736|NCT05046132|182954223|OTHER||LS Mean|6.8|||||TWO_SIDED|90.0|3.4|10.2||||||7 hr Post dose||10.2|3.4|
91537737|NCT05046132|182954223|OTHER||LS Mean|4.5|||||TWO_SIDED|90.0|0.6|8.3||||||8 hr Post dose||8.3|0.6|
91537738|NCT05046132|182954223|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.1|10.0||||||9 hr Post dose||10.0|3.1|
91537739|NCT05046132|182954223|OTHER||LS Mean|6.6|||||TWO_SIDED|90.0|3.0|10.1||||||10 hr Post dose||10.1|3.0|
91537740|NCT05046132|182954223|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.8|8.8||||||12 hr Post dose||8.8|1.8|
91537741|NCT05046132|182954223|OTHER||LS Mean|7.2|||||TWO_SIDED|90.0|3.7|10.6||||||16 hr Post dose||10.6|3.7|
91537742|NCT05046132|182954223|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|-1.0|7.5||||||24 hr Post dose||7.5|-1.0|
91537743|NCT05046132|182954224|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.7|11.8||||||Pre dose||11.8|3.7|
91537744|NCT05046132|182954224|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.3|9.8||||||0.5 hr Post dose||9.8|3.3|
91537745|NCT05046132|182954224|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1 hr Post dose||8.6|0.6|
91537746|NCT05046132|182954224|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1.5 hr Post dose||8.6|0.6|
91537747|NCT05046132|182954224|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|-0.4|8.0||||||2 hr Post dose||8.0|-0.4|
91537748|NCT05046132|182954224|OTHER||LS Mean|6.1|||||TWO_SIDED|90.0|1.8|10.4||||||2.5 hr Post dose||10.4|1.8|
91537749|NCT05046132|182954224|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.7|9.8||||||3 hr Post dose||9.8|1.7|
91537750|NCT05046132|182954224|OTHER||LS Mean|6.2|||||TWO_SIDED|90.0|2.5|9.8||||||4 hr Post dose||9.8|2.5|
91537751|NCT05046132|182954224|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.6|9.8||||||5 hr Post dose||9.8|1.6|
91537752|NCT05046132|182954224|OTHER||LS Mean|4.8|||||TWO_SIDED|90.0|1.1|8.4||||||6 hr Post dose||8.4|1.1|
91537753|NCT05046132|182954224|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.9|7.0||||||7 hr Post dose||7.0|-0.9|
91537754|NCT05046132|182954224|OTHER||LS Mean|5.0|||||TWO_SIDED|90.0|1.3|8.8||||||8 hr Post dose||8.8|1.3|
91537755|NCT05046132|182954224|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.5|10.6||||||9 hr Post dose||10.6|2.5|
91537756|NCT05046132|182954224|OTHER||LS Mean|8.6|||||TWO_SIDED|90.0|4.8|12.3||||||10 hr Post dose||12.3|4.8|
91537757|NCT05046132|182954224|OTHER||LS Mean|7.9|||||TWO_SIDED|90.0|4.4|11.4||||||12 hr Post dose||11.4|4.4|
91537758|NCT05046132|182954224|OTHER||LS Mean|4.9|||||TWO_SIDED|90.0|0.9|8.9||||||16 hr Post dose||8.9|0.9|
91537759|NCT05046132|182954224|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.6|12.0||||||24 hr Post dose||12.0|3.6|
91537760|NCT05046132|182954224|OTHER||LS Mean|2.1|||||TWO_SIDED|90.0|-1.8|6.0||||||Pre dose||6.0|-1.8|
91537761|NCT05046132|182954224|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|0.0|6.2||||||0.5 hr Post dose||6.2|-0.0|
91537762|NCT05046132|182954224|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.9|5.7||||||1 hr Post dose||5.7|-1.9|
91537763|NCT05046132|182954224|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.6|10.4||||||1.5 hr Post dose||10.4|2.6|
91537764|NCT05046132|182954224|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.3|9.3||||||2 hr Post dose||9.3|1.3|
91537765|NCT05046132|182954224|OTHER||LS Mean|11.1|||||TWO_SIDED|90.0|7.0|15.1||||||2.5 hr Post dose||15.1|7.0|
91537766|NCT05046132|182954224|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.6||||||3 hr Post dose||13.6|5.9|
91537767|NCT05046132|182954224|OTHER||LS Mean|10.7|||||TWO_SIDED|90.0|7.2|14.2||||||4 hr Post dose||14.2|7.2|
91537768|NCT05046132|182954224|OTHER||LS Mean|8.8|||||TWO_SIDED|90.0|4.9|12.7||||||5 hr Post dose||12.7|4.9|
91537769|NCT05046132|182954224|OTHER||LS Mean|11.0|||||TWO_SIDED|90.0|7.5|14.5||||||6 hr Post dose||14.5|7.5|
91537770|NCT05046132|182954224|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|7.1|14.6||||||7 hr Post dose||14.6|7.1|
91537771|NCT05046132|182954224|OTHER||LS Mean|11.3|||||TWO_SIDED|90.0|7.6|14.9||||||8 hr Post dose||14.9|7.6|
91537772|NCT05046132|182954224|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.7||||||9 hr Post dose||13.7|5.9|
91537773|NCT05046132|182954224|OTHER||LS Mean|10.5|||||TWO_SIDED|90.0|6.9|14.1||||||10 hr Post dose||14.1|6.9|
91537774|NCT05046132|182954224|OTHER||LS Mean|11.8|||||TWO_SIDED|90.0|8.4|15.2||||||12 hr Post dose||15.2|8.4|
91537775|NCT05046132|182954224|OTHER||LS Mean|9.4|||||TWO_SIDED|90.0|5.6|13.3||||||16 hr Post dose||13.3|5.6|
91537776|NCT05046132|182954224|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|6.8|14.9||||||24 hr Post dose||14.9|6.8|
91537777|NCT05046132|182954225|OTHER||LS Mean|-5.3|||||TWO_SIDED|90.0|-8.4|-2.2||||||Pre dose||-2.2|-8.4|
91537778|NCT05046132|182954225|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.9|0.5||||||0.5 hr Post dose||0.5|-5.9|
91537779|NCT05046132|182954225|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-5.7|-0.7||||||1 hr Post dose||-0.7|-5.7|
91537780|NCT05046132|182954225|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.7|1.9||||||1.5 hr Post dose||1.9|-3.7|
91537781|NCT05046132|182954225|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-5.7|-0.2||||||2 hr Post dose||-0.2|-5.7|
91537782|NCT05046132|182954225|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.5|-1.5||||||2.5 hr Post dose||-1.5|-6.5|
91537783|NCT05046132|182954225|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.1|-1.3||||||3 hr Post dose||-1.3|-7.1|
91537784|NCT05046132|182954225|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||4 hr Post dose||-0.8|-7.4|
91537785|NCT05046132|182954225|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.7|2.1||||||5 hr Post dose||2.1|-3.7|
91537786|NCT05046132|182954225|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.4||||||6 hr Post dose||-0.4|-6.3|
91537787|NCT05046132|182954225|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.0|-0.5||||||7 hr Post dose||-0.5|-6.0|
91537788|NCT05046132|182954225|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.5||||||8 hr Post dose||1.5|-4.7|
91537789|NCT05046132|182954225|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.9|-1.2||||||9 hr Post dose||-1.2|-6.9|
91763237|NCT03726489|183416998|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|11.97|||<|0.0001|TWO_SIDED|95.0|6.52|17.42||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||17.42|6.52|<0.0001
91763238|NCT03726489|183416998|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.15|||<|0.0001|TWO_SIDED|95.0|7.54|24.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.75|7.54|<0.0001
91537790|NCT05046132|182954225|OTHER||LS Mean|-4.3|||||TWO_SIDED|90.0|-7.6|-1.0||||||10 hr Post dose||-1.0|-7.6|
91537791|NCT05046132|182954225|OTHER||LS Mean|-5.4|||||TWO_SIDED|90.0|-8.7|-2.1||||||12 hr Post dose||-2.1|-8.7|
91537792|NCT05046132|182954225|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||16 hr Post dose||-0.8|-7.4|
91537793|NCT05046132|182954225|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.1|-4.2||||||24 hr Post dose||-4.2|-10.1|
91763239|NCT03726489|183416998|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|5.56|||<|0.0001|TWO_SIDED|95.0|-2.35|13.46||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||13.46|-2.35|<0.0001
91763240|NCT03726489|183416998|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.37|||<|0.0001|TWO_SIDED|95.0|7.65|35.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.09|7.65|<0.0001
91537794|NCT05046132|182954225|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.0|4.2||||||Pre dose||4.2|-2.0|
91537795|NCT05046132|182954225|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|-0.1|6.3||||||0.5 hr Post dose||6.3|-0.1|
91537796|NCT05046132|182954225|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-0.1|4.9||||||1 hr Post dose||4.9|-0.1|
91537797|NCT05046132|182954225|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|0.2|5.8||||||1.5 hr Post dose||5.8|0.2|
91537798|NCT05046132|182954225|OTHER||LS Mean|1.8|||||TWO_SIDED|90.0|-1.0|4.6||||||2 hr Post dose||4.6|-1.0|
91537799|NCT05046132|182954225|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.9|3.1||||||2.5 hr Post dose||3.1|-1.9|
91537800|NCT05046132|182954225|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||3 hr Post dose||4.8|-1.0|
91537801|NCT05046132|182954225|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-3.5|3.0||||||4 hr Post dose||3.0|-3.5|
91537802|NCT05046132|182954225|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.6|3.2||||||5 hr Post dose||3.2|-2.6|
91537803|NCT05046132|182954225|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-4.8|1.1||||||6 hr Post dose||1.1|-4.8|
91537804|NCT05046132|182954225|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-3.8|1.7||||||7 hr Post dose||1.7|-3.8|
91537805|NCT05046132|182954225|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.6|2.6||||||8 hr Post dose||2.6|-3.6|
91537806|NCT05046132|182954225|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.6|0.2||||||9 hr Post dose||0.2|-5.6|
91537807|NCT05046132|182954225|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.8|-0.2||||||10 hr Post dose||-0.2|-6.8|
91537808|NCT05046132|182954225|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.6|0.1||||||12 hr Post dose||0.1|-6.6|
91537809|NCT05046132|182954225|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||16 hr Post dose||3.6|-3.0|
91537810|NCT05046132|182954225|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||24 hr Post dose||2.9|-3.0|
91537811|NCT05046132|182954226|OTHER||LS Mean|-6.6|||||TWO_SIDED|90.0|-10.3|-3.0||||||Pre dose||-3.0|-10.3|
91537812|NCT05046132|182954226|OTHER||LS Mean|-7.3|||||TWO_SIDED|90.0|-10.5|-4.0||||||0.5 hr Post dose||-4.0|-10.5|
91537813|NCT05046132|182954226|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.8|-1.2||||||1 hr Post dose||-1.2|-8.8|
91537814|NCT05046132|182954226|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.4|-1.6||||||1.5 hr Post dose||-1.6|-8.4|
91537815|NCT05046132|182954226|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.6|-0.3||||||2 hr Post dose||-0.3|-6.6|
91537816|NCT05046132|182954226|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-6.1|0.3||||||2.5 hr Post dose||0.3|-6.1|
91537817|NCT05046132|182954226|OTHER||LS Mean|-4.6|||||TWO_SIDED|90.0|-7.7|-1.5||||||3 hr Post dose||-1.5|-7.7|
91537818|NCT05046132|182954226|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.3|-3.8||||||4 hr Post dose||-3.8|-10.3|
91537819|NCT05046132|182954226|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-6.9|0.6||||||5 hr Post dose||0.6|-6.9|
91537820|NCT05046132|182954226|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.8|-0.6||||||6 hr Post dose||-0.6|-7.8|
91537821|NCT05046132|182954226|OTHER||LS Mean|-4.8|||||TWO_SIDED|90.0|-8.1|-1.6||||||7 hr Post dose||-1.6|-8.1|
91537822|NCT05046132|182954226|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||8 hr Post dose||-1.1|-7.8|
91537823|NCT05046132|182954226|OTHER||LS Mean|-5.9|||||TWO_SIDED|90.0|-9.3|-2.6||||||9 hr Post dose||-2.6|-9.3|
91537824|NCT05046132|182954226|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||10 hr Post dose||-1.1|-7.8|
91537825|NCT05046132|182954226|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.3|-1.1||||||12 hr Post dose||-1.1|-7.3|
91537826|NCT05046132|182954226|OTHER||LS Mean|-5.8|||||TWO_SIDED|90.0|-9.7|-2.0||||||16 hr Post dose||-2.0|-9.7|
91537827|NCT05046132|182954226|OTHER||LS Mean|-8.2|||||TWO_SIDED|90.0|-12.5|-3.8||||||24 hr Post dose||-3.8|-12.5|
91537828|NCT05046132|182954226|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.2|5.9||||||Pre dose||5.9|-1.2|
91537829|NCT05046132|182954226|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-4.5|1.8||||||0.5 hr Post dose||1.8|-4.5|
91537830|NCT05046132|182954226|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-4.0|3.3||||||1 hr Post dose||3.3|-4.0|
91537831|NCT05046132|182954226|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||1.5 hr Post dose||3.6|-3.0|
91537832|NCT05046132|182954226|OTHER||LS Mean|-1.0|||||TWO_SIDED|90.0|-4.0|2.0||||||2 hr Post dose||2.0|-4.0|
91537833|NCT05046132|182954226|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-2.6|3.6||||||2.5 hr Post dose||3.6|-2.6|
91537834|NCT05046132|182954226|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-3.7|2.3||||||3 hr Post dose||2.3|-3.7|
91537835|NCT05046132|182954226|OTHER||LS Mean|-2.3|||||TWO_SIDED|90.0|-5.4|0.9||||||4 hr Post dose||0.9|-5.4|
91537836|NCT05046132|182954226|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.5|4.6||||||5 hr Post dose||4.6|-2.5|
91537837|NCT05046132|182954226|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-4.1|2.8||||||6 hr Post dose||2.8|-4.1|
91537838|NCT05046132|182954226|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.0|1.3||||||7 hr Post dose||1.3|-5.0|
91537839|NCT05046132|182954226|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.7|2.8||||||8 hr Post dose||2.8|-3.7|
91537840|NCT05046132|182954226|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.4|3.1||||||9 hr Post dose||3.1|-3.4|
91537841|NCT05046132|182954226|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.8|3.7||||||10 hr Post dose||3.7|-2.8|
91537842|NCT05046132|182954226|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.9|3.1||||||12 hr Post dose||3.1|-2.9|
91537843|NCT05046132|182954226|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-3.1|4.3||||||16 hr Post dose||4.3|-3.1|
91537844|NCT05046132|182954226|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-2.5|5.9||||||24 hr Post dose||5.9|-2.5|
91537845|NCT05046132|182954227|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-2.6|1.2||||||Pre dose||1.2|-2.6|
91537846|NCT05046132|182954227|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-2.6|0.7||||||0.5 hr post dose||0.7|-2.6|
91537847|NCT05046132|182954227|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.3||||||1 hr post dose||2.3|-1.1|
91537848|NCT05046132|182954227|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.5|1.3||||||1.5 hr post dose||1.3|-1.5|
91537849|NCT05046132|182954227|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.8|2.4||||||2 hr post dose||2.4|-0.8|
91537850|NCT05046132|182954227|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||2.5 hr post dose||2.4|-1.0|
91537851|NCT05046132|182954227|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.6|2.0||||||3 hr post dose||2.0|-1.6|
91537852|NCT05046132|182954227|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.9|2.3||||||4 hr post dose||2.3|-0.9|
91537853|NCT05046132|182954227|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.1||||||5 hr post dose||2.1|-1.2|
91537854|NCT05046132|182954227|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.7|2.4||||||6 hr post dose||2.4|-0.7|
91537855|NCT05046132|182954227|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.4||||||7 hr post dose||2.4|-0.6|
91537856|NCT05046132|182954227|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.0|2.2||||||8 hr post dose||2.2|-1.0|
91537857|NCT05046132|182954227|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
91537858|NCT05046132|182954227|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.5|1.6||||||10 hr post dose||1.6|-1.5|
91513923|NCT03779841|182899903|SUPERIORITY||Risk Ratio (RR)|0.69||||0.4065|TWO_SIDED|95.0|0.28|1.67|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.67|0.28|0.4065
91513924|NCT03779841|182899903|SUPERIORITY||Risk Ratio (RR)|1.28||||0.5257|TWO_SIDED|95.0|0.6|2.7|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.70|0.60|0.5257
91513925|NCT03779841|182899904|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1612|TWO_SIDED|95.0|0.55|1.11|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.11|0.55|0.1612
91513926|NCT03779841|182899904|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9966|TWO_SIDED|95.0|0.74|1.35|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.35|0.74|0.9966
91513927|NCT03779841|182899905|SUPERIORITY||Risk Ratio (RR)|0.68||||0.3374|TWO_SIDED|95.0|0.3|1.52|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.52|0.30|0.3374
91513928|NCT03779841|182899905|SUPERIORITY||Risk Ratio (RR)|1.23||||0.5403|TWO_SIDED|95.0|0.62|2.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.45|0.62|0.5403
91513929|NCT03779841|182899906|SUPERIORITY||Risk Ratio (RR)|3.94||||0.0163|TWO_SIDED|95.0|1.16|13.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||13.42|1.16|0.0163
91513930|NCT03779841|182899906|SUPERIORITY||Risk Ratio (RR)|2.7||||0.1101|TWO_SIDED|95.0|0.76|9.64|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||9.64|0.76|0.1101
91513931|NCT03779841|182899907|SUPERIORITY||Risk Ratio (RR)|0.86||||0.3339|TWO_SIDED|95.0|0.64|1.16|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.16|0.64|0.3339
91513932|NCT03779841|182899907|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4614|TWO_SIDED|95.0|0.85|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.85|0.4614
91513933|NCT03117387|182899910|OTHER|Bland-Altman analysis estimates bias between TOF-Cuff and electromyography.|bias|0.0|||||TWO_SIDED|0.05|-0.05|0.05||||||"Paired measurements were compared using a Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis, Leiden, the Netherlands).~This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects."||0.05|-0.05|
91763241|NCT03726489|183416999|SUPERIORITY||Risk Difference (RD)|11.68||||0.0065|TWO_SIDED|95.0|3.27|20.08||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||20.08|3.27|0.0065
91763242|NCT03726489|183416999|SUPERIORITY||Risk Difference (RD)|12.31||||0.0478|TWO_SIDED|95.0|0.03|24.49||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.49|0.03|0.0478
91763243|NCT03726489|183416999|SUPERIORITY||Risk Difference (RD)|13.25||||0.0431|TWO_SIDED|95.0|0.52|25.98||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||25.98|0.52|0.0431
91763244|NCT03726489|183416999|SUPERIORITY||Risk Difference (RD)|1.5||||0.9133|TWO_SIDED|95.0|-25.5|28.5||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||28.50|-25.50|0.9133
91763245|NCT03726489|183417000|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.048|TWO_SIDED|95.0|-15.73|-0.07||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.07|-15.73|0.048
91763246|NCT03726489|183417000|SUPERIORITY||Mean Difference (Final Values)|-10.67||||0.1199|TWO_SIDED|95.0|-24.15|2.8||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||2.80|-24.15|0.1199
91763247|NCT03726489|183417000|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.2953|TWO_SIDED|95.0|-15.26|4.66||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||4.66|-15.26|0.2953
91763248|NCT03726489|183417000|SUPERIORITY||Mean Difference (Final Values)|-8.83||||0.5124|TWO_SIDED|95.0|-35.77|18.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||18.11|-35.77|0.5124
91763249|NCT03726489|183417001|SUPERIORITY||Risk Difference (RD)|10.9||||0.0173|TWO_SIDED|95.0|1.93|19.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||19.87|1.93|0.0173
91763250|NCT03726489|183417001|SUPERIORITY||Risk Difference (RD)|13.06||||0.0662|TWO_SIDED|95.0|-0.81|26.94||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||26.94|-0.81|0.0662
91763251|NCT03726489|183417001|SUPERIORITY||Risk Difference (RD)|8.58||||0.1976|TWO_SIDED|95.0|-4.42|21.57||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||21.57|-4.42|0.1976
91537859|NCT05046132|182954227|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-0.2|3.0||||||12 hr post dose||3.0|-0.2|
91537860|NCT05046132|182954227|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||16 hr post dose||3.4|-0.3|
91763252|NCT03726489|183417001|SUPERIORITY||Risk Difference (RD)|13.04||||0.3595|TWO_SIDED|95.0|-14.6|40.69||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||40.69|-14.60|0.3595
91763253|NCT03726489|183417002|SUPERIORITY||Risk Difference (RD)|7.55||||0.0853|TWO_SIDED|95.0|-1.05|16.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||16.14|-1.05|0.0853
91763254|NCT03726489|183417002|SUPERIORITY||Risk Difference (RD)|2.26||||0.7488|TWO_SIDED|95.0|-11.54|16.06||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||16.06|-11.54|0.7488
91763255|NCT03726489|183417002|SUPERIORITY||Risk Difference (RD)|10.12||||0.1051|TWO_SIDED|95.0|-2.03|22.26||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||22.26|-2.03|0.1051
91763256|NCT03726489|183417002|SUPERIORITY||Risk Difference (RD)|17.39||||0.1792|TWO_SIDED|95.0|-7.48|42.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||42.27|-7.48|0.1792
91537861|NCT05046132|182954227|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-2.1|1.6||||||24 hr post dose||1.6|-2.1|
91537862|NCT05046132|182954227|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.2|2.6||||||Pre dose||2.6|-1.2|
91537863|NCT05046132|182954227|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.9|1.4||||||0.5 hr post dose||1.4|-1.9|
91537864|NCT05046132|182954227|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.2||||||1 hr post dose||2.2|-1.2|
91537865|NCT05046132|182954227|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.7|2.1||||||1.5 hr post dose||2.1|-0.7|
91537866|NCT05046132|182954227|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.2||||||2 hr post dose||2.2|-1.1|
91513934|NCT05349617|182899918|SUPERIORITY||Percent Difference|86.2|||<|0.0001|TWO_SIDED|95.0|80.0|90.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||90.3|80|<0.0001
91537867|NCT05046132|182954227|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.9|2.5||||||2.5 hr post dose||2.5|-0.9|
91763257|NCT03726489|183417003|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.175|TWO_SIDED|95.0|-1.37|7.5||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||7.50|-1.37|0.175
91537868|NCT05046132|182954227|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.5|2.1||||||3 hr post dose||2.1|-1.5|
91537869|NCT05046132|182954227|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-2.1|1.1||||||4 hr post dose||1.1|-2.1|
91537870|NCT05046132|182954227|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.5|1.9||||||5 hr post dose||1.9|-1.5|
91763258|NCT03726489|183417003|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.8904|TWO_SIDED|95.0|-6.34|5.51||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||5.51|-6.34|0.8904
91763259|NCT03726489|183417003|SUPERIORITY||Mean Difference (Final Values)|7.59||||0.0412|TWO_SIDED|95.0|0.31|14.88||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||14.88|0.31|0.0412
91763260|NCT03726489|183417003|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.5481|TWO_SIDED|95.0|-13.38|24.38||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||24.38|-13.38|0.5481
91763261|NCT03726489|183417003|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.458|TWO_SIDED|95.0|0.471|1.403|||Regression, Cox|Failure event corresponds to DLQI assessment greater than 5. Model adjusted for skin phototype.|Office phototherapy is the reference group.|Cox proportional hazards model for maintaining treatment response after week 12.||1.403|0.471|0.458
91763262|NCT03726489|183417004|SUPERIORITY||Risk Difference (RD)|38.1|||<|0.0001|TWO_SIDED|95.0|30.34|45.86||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||45.86|30.34|<0.0001
91763263|NCT03726489|183417004|SUPERIORITY||Risk Difference (RD)|38.86|||<|0.0001|TWO_SIDED|95.0|27.39|50.33||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||50.33|27.39|<0.0001
91763264|NCT03726489|183417004|SUPERIORITY||Risk Difference (RD)|42.21|||<|0.0001|TWO_SIDED|95.0|30.73|53.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||53.68|30.73|<0.0001
91763265|NCT03726489|183417004|SUPERIORITY||Risk Difference (RD)|15.74||||0.234|TWO_SIDED|95.0|-9.63|41.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||41.11|-9.63|0.2340
91763266|NCT03726489|183417005|SUPERIORITY||Risk Difference (RD)|43.96|||<|0.0001|TWO_SIDED|95.0|37.25|50.66||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||50.66|37.25|<0.0001
91537871|NCT05046132|182954227|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.7|1.4||||||6 hr post dose||1.4|-1.7|
91537872|NCT05046132|182954227|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.4||||||7 hr post dose||1.4|-1.6|
91537873|NCT05046132|182954227|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.7|2.4||||||8 hr post dose||2.4|-0.7|
91537874|NCT05046132|182954227|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
91537875|NCT05046132|182954227|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.4|1.6||||||10 hr post dose||1.6|-1.4|
91537876|NCT05046132|182954227|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.1|3.1||||||12 hr post dose||3.1|-0.1|
91537877|NCT05046132|182954227|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-0.7|3.0||||||16 hr post dose||3.0|-0.7|
91537878|NCT05046132|182954227|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||24 hr post dose||3.4|-0.3|
91537879|NCT05046132|182954228|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-1.3|2.9||||||Pre dose||2.9|-1.3|
91537880|NCT05046132|182954228|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.8|1.2||||||0.5 hr post dose||1.2|-1.8|
91537881|NCT05046132|182954228|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-1.4|3.8||||||1 hr post dose||3.8|-1.4|
91537882|NCT05046132|182954228|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.8|1.8||||||1.5 hr post dose||1.8|-1.8|
91537883|NCT05046132|182954228|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-3.0|0.3||||||2 hr post dose||0.3|-3.0|
91537884|NCT05046132|182954228|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|0.0|3.1||||||2.5 hr post dose||3.1|-0.0|
91537885|NCT05046132|182954228|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.7|1.5||||||3 hr post dose||1.5|-1.7|
91537886|NCT05046132|182954228|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.3|2.9||||||4 hr post dose||2.9|-0.3|
91537887|NCT05046132|182954228|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.2|2.0||||||5 hr post dose||2.0|-2.2|
91537888|NCT05046132|182954228|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||6 hr post dose||2.3|-0.8|
91537889|NCT05046132|182954228|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.8|2.7||||||7 hr post dose||2.7|-0.8|
91537890|NCT05046132|182954228|OTHER||LS Mean|1.0|||||TWO_SIDED|90.0|-0.3|2.4||||||8 hr post dose||2.4|-0.3|
91537891|NCT05046132|182954228|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-0.7|2.9||||||9 hr post dose||2.9|-0.7|
91537892|NCT05046132|182954228|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.4|1.9||||||10 hr post dose||1.9|-1.4|
91537893|NCT05046132|182954228|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.6|3.2||||||12 hr post dose||3.2|-0.6|
91537894|NCT05046132|182954228|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||16 hr post dose||2.4|-1.0|
91537895|NCT05046132|182954228|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.0|4.2||||||24 hr post dose||4.2|-1.0|
91537896|NCT05046132|182954228|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.3|1.7||||||Pre dose||1.7|-2.3|
91537897|NCT05046132|182954228|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.3||||||0.5 hr post dose||1.3|-1.6|
91537898|NCT05046132|182954228|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-3.8|1.2||||||1 hr post dose||1.2|-3.8|
91537899|NCT05046132|182954228|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.7|1.8||||||1.5 hr post dose||1.8|-1.7|
91537900|NCT05046132|182954228|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||2 hr post dose||0.5|-2.7|
91537901|NCT05046132|182954228|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||2.5 hr post dose||2.3|-0.8|
91537902|NCT05046132|182954228|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.3|1.8||||||3 hr post dose||1.8|-1.3|
91537903|NCT05046132|182954228|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.2|1.9||||||4 hr post dose||1.9|-1.2|
91537904|NCT05046132|182954228|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-3.5|0.5||||||5 hr post dose||0.5|-3.5|
91537905|NCT05046132|182954228|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.3||||||6 hr post dose||2.3|-0.6|
91537906|NCT05046132|182954228|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.1||||||7 hr post dose||2.1|-1.3|
91537907|NCT05046132|182954228|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|0.0|2.6||||||8 hr post dose||2.6|-0.0|
91537908|NCT05046132|182954228|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.2||||||9 hr post dose||2.2|-1.3|
91537909|NCT05046132|182954228|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||10 hr post dose||0.5|-2.7|
91537910|NCT05046132|182954228|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.1|1.5||||||12 hr post dose||1.5|-2.1|
91537911|NCT05046132|182954228|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.9|1.4||||||16 hr post dose||1.4|-1.9|
91537912|NCT05046132|182954228|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-0.2|4.9||||||24 hr post dose||4.9|-0.2|
91537913|NCT00414648|182954265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The model included the time since enrollment, the treatment assignment, and the interaction between time and treatment.|Regression, Linear|Mixed model with the use of the Kenward-Roger correction without imputation of missing data.||FEV1 slope||||<0.001
91537914|NCT00414648|182954266|OTHER|||||||0.441|||||||Chi-squared|||||||.441
91537915|NCT00414648|182954267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
91537916|NCT00414648|182954268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|GLM adjusted for baseline||||||0.17
91537917|NCT00414648|182954269|SUPERIORITY|||||||0.34|||||||Regression, Linear|GLM adjusted for baseline||||||0.34
91537918|NCT00414648|182954270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Regression, Linear|GLM adjusted for baseline||||||0.88
91537919|NCT00414648|182954271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
91763267|NCT03726489|183417005|SUPERIORITY||Risk Difference (RD)|39.85|||<|0.0001|TWO_SIDED|95.0|30.0|49.7||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||49.70|30.0|<0.0001
91763268|NCT03726489|183417005|SUPERIORITY||Risk Difference (RD)|50.18|||<|0.0001|TWO_SIDED|95.0|40.09|60.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||60.27|40.09|<0.0001
91763269|NCT03726489|183417005|SUPERIORITY||Risk Difference (RD)|36.11|||<|0.0001|TWO_SIDED|95.0|14.35|57.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||57.87|14.35|<0.0001
91763270|NCT03726489|183417006|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-5.2||||0.1773|TWO_SIDED|95.0|-19.4|9.0||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||9.0|-19.4|0.1773
91763271|NCT03726489|183417006|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-6.88||||0.4073|TWO_SIDED|95.0|-26.09|12.33||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||12.33|-26.09|0.4073
91763272|NCT03726489|183417006|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-12.42||||0.8247|TWO_SIDED|95.0|-35.24|10.41||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||10.41|-35.24|0.8247
91763273|NCT03726489|183417006|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|37.88||||0.0133|TWO_SIDED|95.0|-4.01|79.77||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||79.77|-4.01|0.0133
91763274|NCT03726489|183417007|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|6.52||||0.002|TWO_SIDED|95.0|-7.11|20.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||20.14|-7.11|0.002
91763275|NCT03726489|183417007|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.77||||0.0137|TWO_SIDED|95.0|-10.35|25.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||25.89|-10.35|0.0137
91763276|NCT03726489|183417007|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|1.0||||0.1656|TWO_SIDED|95.0|-21.61|23.61||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||23.61|-21.61|0.1656
91763277|NCT03726489|183417007|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|22.73||||0.1225|TWO_SIDED|95.0|-25.16|70.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||70.62|-25.16|0.1225
91537920|NCT02371746|182954272|SUPERIORITY||Change from baseline|30.4|STANDARD_DEVIATION|1.84|<|0.001|TWO_SIDED|95.0|-1.8|36.6|||ANCOVA|||estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost||36.6|-1.8|<0.001
91537921|NCT01490580|182954291|SUPERIORITY||Risk Difference (RD)|-6.4||||0.38|TWO_SIDED|95.0|-21.0|8.1|||Mixed Models Analysis|||||8.1|-21.0|0.38
91537922|NCT02026258|182954300|OTHER||Mean Difference (Final Values)|0.52|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.||||<0.05
91537923|NCT02026258|182954301|OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T0||||<0.05
91537924|NCT02026258|182954301|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T1||||<0.05
91537925|NCT02026258|182954301|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T2||||<0.05
91537926|NCT02026258|182954301|OTHER||Mean Difference (Final Values)|0.76|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T3||||<0.05
91537927|NCT02026258|182954302|OTHER||Mean Difference (Final Values)|0.87|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ease of Procedure||||<0.05
91537928|NCT02026258|182954302|OTHER||Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Satisfaction with procedure||||<0.05
91537929|NCT02026258|182954303|OTHER||Fisher chi square|0.71|||<|0.05|TWO_SIDED||||||Fisher Exact|Use of Medications||||||<0.05
91537930|NCT02026258|182954303|OTHER||Fisher chi square|0.99|||<|0.05|TWO_SIDED||||||Fisher Exact|||Undergo procedure again||||<0.05
91537931|NCT02026258|182954303|OTHER||Fisher chi square|0.49|||<|0.05|TWO_SIDED||||||Fisher Exact|||Recommend procedure to a friend||||<0.05
91537932|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-1.6||||0.0133|TWO_SIDED|95.0|-2.87|-0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.34|-2.87|0.0133
91537933|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-2.26||||0.0006|TWO_SIDED|95.0|-3.54|-0.98|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.98|-3.54|0.0006
91763278|NCT03726489|183417008|SUPERIORITY||Risk Difference (RD)|0.105||||0.0183|TWO_SIDED|95.0|0.018|0.192|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 16. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.192|0.018|0.0183
91763279|NCT03726489|183417008|SUPERIORITY||Risk Difference (RD)|0.064||||0.177|TWO_SIDED|95.0|-0.029|0.158|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 20. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.158|-0.029|0.177
91537934|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0394|TWO_SIDED|95.0|-3.06|-0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||-0.08|-3.06|0.0394
91537935|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-1.65||||0.0332|TWO_SIDED|95.0|-3.16|-0.13|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.13|-3.16|0.0332
91537936|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-1.82||||0.0601|TWO_SIDED|95.0|-3.71|0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.08|-3.71|0.0601
91537937|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-2.03||||0.0369|TWO_SIDED|95.0|-3.94|-0.12|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.12|-3.94|0.0369
91537938|NCT00880048|182954327|SUPERIORITY||Mean Difference (Net)|-1.67||||0.1122|TWO_SIDED|95.0|-3.73|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.39|-3.73|0.1122
91537939|NCT00880048|182954327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.4713|TWO_SIDED|95.0|-2.85|1.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||1.32|-2.85|0.4713
91537940|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2232|TWO_SIDED|95.0|0.63|7.39|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||7.39|0.63|0.2232
91537941|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0559|TWO_SIDED|95.0|0.97|10.2|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||10.2|0.97|0.0559
91537942|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3395|TWO_SIDED|95.0|0.64|3.61|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||3.61|0.64|0.3395
91537943|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4256|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||3.50|0.59|0.4256
91537944|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|1.35||||0.379|TWO_SIDED|95.0|0.69|2.64|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.64|0.69|0.3790
91537945|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2554|TWO_SIDED|95.0|0.76|2.86|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.86|0.76|0.2554
91537946|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|1.53||||0.1961|TWO_SIDED|95.0|0.8|2.91|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.91|0.80|0.1961
91537947|NCT00880048|182954328|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6916|TWO_SIDED|95.0|0.58|2.25|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.25|0.58|0.6916
91537948|NCT00880048|182954329|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.61|TWO_SIDED|95.0|0.5|1.95|||Log Rank|||||1.95|0.50|0.61
91537949|NCT00880048|182954329|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.35|TWO_SIDED|95.0|0.36|1.54|||Log Rank|||||1.54|0.36|0.35
91537950|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.69||||0.0362|TWO_SIDED|95.0|-1.34|-0.04|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.04|-1.34|0.0362
91537951|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.81||||0.0155|TWO_SIDED|95.0|-1.46|-0.16|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.16|-1.46|0.0155
91537952|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.46||||0.2593|TWO_SIDED|95.0|-1.27|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.34|-1.27|0.2593
91537953|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.62||||0.1407|TWO_SIDED|95.0|-1.44|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-1.44|0.1407
91537954|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.67||||0.1933|TWO_SIDED|95.0|-1.67|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.34|-1.67|0.1933
91537955|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.74||||0.15|TWO_SIDED|95.0|-1.76|0.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||0.27|-1.76|0.1500
91537956|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-1.09||||0.055|TWO_SIDED|95.0|-2.21|0.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.02|-2.21|0.0550
91537957|NCT00880048|182954330|SUPERIORITY||Mean Difference (Net)|-0.52||||0.3627|TWO_SIDED|95.0|-1.65|0.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.61|-1.65|0.3627
91537958|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.03||||0.0616|TWO_SIDED|95.0|-2.11|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-2.11|0.0616
91537959|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-2.28|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-1.19|-3.36|<0.0001
91537960|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.44||||0.0239|TWO_SIDED|95.0|-2.68|-0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||-0.19|-2.68|0.0239
91537961|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.84||||0.0048|TWO_SIDED|95.0|-3.12|-0.57|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.57|-3.12|0.0048
91537962|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.58||||0.027|TWO_SIDED|95.0|-2.97|-0.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||-0.18|-2.97|0.0270
91537963|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.86||||0.0103|TWO_SIDED|95.0|-3.27|-0.44|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.44|-3.27|0.0103
91537964|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.53||||0.0497|TWO_SIDED|95.0|-3.06|0.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.00|-3.06|0.0497
91537965|NCT00880048|182954331|SUPERIORITY||Mean Difference (Net)|-1.41||||0.0794|TWO_SIDED|95.0|-2.98|0.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.17|-2.98|0.0794
91537966|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.28||||0.24|TWO_SIDED|95.0|-0.75|0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.19|-0.75|0.2400
91537967|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.76||||0.002|TWO_SIDED|95.0|-1.23|-0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.28|-1.23|0.0020
91537968|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.15||||0.5605|TWO_SIDED|95.0|-0.67|0.36|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.36|-0.67|0.5605
91537969|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.33||||0.2215|TWO_SIDED|95.0|-0.86|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-0.86|0.2215
91537970|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.35||||0.287|TWO_SIDED|95.0|-1.01|0.3|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.30|-1.01|0.2870
91537971|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.67||||0.0465|TWO_SIDED|95.0|-1.33|-0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.01|-1.33|0.0465
91537972|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.32||||0.3399|TWO_SIDED|95.0|-0.99|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.34|-0.99|0.3399
91537973|NCT00880048|182954332|SUPERIORITY||Mean Difference (Net)|-0.18||||0.5931|TWO_SIDED|95.0|-0.86|0.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.49|-0.86|0.5931
91537974|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0562|TWO_SIDED|95.0|0.97|8.22|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||8.22|0.97|0.0562
91537975|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1596|TWO_SIDED|95.0|0.73|6.73|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||6.73|0.73|0.1596
91537976|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0067|TWO_SIDED|95.0|1.34|6.3|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||6.30|1.34|0.0067
91537977|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1154|TWO_SIDED|95.0|0.85|4.36|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||4.36|0.85|0.1154
91537978|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|1.13||||0.6895|TWO_SIDED|95.0|0.62|2.07|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.07|0.62|0.6895
91537979|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3654|TWO_SIDED|95.0|0.72|2.41|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.41|0.72|0.3654
91537980|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|1.44||||0.2408|TWO_SIDED|95.0|0.78|2.65|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.65|0.78|0.2408
91537981|NCT00880048|182954333|SUPERIORITY||Odds Ratio (OR)|1.39||||0.3066|TWO_SIDED|95.0|0.74|2.6|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.60|0.74|0.3066
91537982|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1472|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-0.36|0.1472
91537983|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0107|TWO_SIDED|95.0|-0.48|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.06|-0.48|0.0107
91537984|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0603|TWO_SIDED|95.0|-0.51|0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.01|-0.51|0.0603
91537985|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.2||||0.1458|TWO_SIDED|95.0|-0.46|0.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.07|-0.46|0.1458
91537986|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0941|TWO_SIDED|95.0|-0.58|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.05|-0.58|0.0941
91537987|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.27||||0.088|TWO_SIDED|95.0|-0.59|0.04|||Mixed Models Repeated Measures||Placebo vs GW823296 60mg: Week 4|||0.04|-0.59|0.0880
91537988|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.38||||0.0313|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.03|-0.73|0.0313
91537989|NCT00880048|182954334|SUPERIORITY||Mean Difference (Net)|-0.2||||0.2639|TWO_SIDED|95.0|-0.55|0.15|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.15|-0.55|0.2639
91537990|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0421|TWO_SIDED|95.0|-3.08|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.06|-3.08|0.0421
91537991|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-0.74||||0.3394|TWO_SIDED|95.0|-2.27|0.78|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.78|-2.27|0.3394
91537992|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0963|TWO_SIDED|95.0|-3.05|0.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.25|-3.05|0.0963
91537993|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-1.94||||0.0235|TWO_SIDED|95.0|-3.62|-0.26|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||-0.26|-3.62|0.0235
91537994|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-0.77||||0.3956|TWO_SIDED|95.0|-2.54|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||1.01|-2.54|0.3956
91537995|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-0.73||||0.4273|TWO_SIDED|95.0|-2.53|1.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.07|-2.53|0.4273
91537996|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-0.94||||0.3429|TWO_SIDED|95.0|-2.89|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.01|-2.89|0.3429
91537997|NCT00880048|182954335|SUPERIORITY||Mean Difference (Net)|-1.19||||0.2403|TWO_SIDED|95.0|-3.18|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.80|-3.18|0.2403
91537998|NCT00880048|182954336|SUPERIORITY||Mixed effects repeated measures model|22.52||||0.103|TWO_SIDED|95.0|-4.58|49.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, total sleep time||49.61|-4.58|0.1030
91537999|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|33.21||||0.0179|TWO_SIDED|95.0|5.76|60.65|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, total sleep time||60.65|5.76|0.0179
91538000|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|7.62||||0.5773|TWO_SIDED|95.0|-19.25|34.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, total sleep time||34.49|-19.25|0.5773
91538001|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|21.4||||0.125|TWO_SIDED|95.0|-5.97|48.76|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, total sleep time||48.76|-5.97|0.1250
91538002|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|30.87||||0.0344|TWO_SIDED|95.0|2.29|59.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, total sleep time||59.45|2.29|0.0344
91538003|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|36.52||||0.0131|TWO_SIDED|95.0|7.72|65.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, total sleep time||65.32|7.72|0.0131
91538004|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|2.18||||0.8794|TWO_SIDED|95.0|-26.1|30.46|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, total sleep time||30.46|-26.10|0.8794
91538005|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|28.4||||0.0556|TWO_SIDED|95.0|-0.69|57.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, total sleep time||57.50|-0.69|0.0556
91538006|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-23.9||||0.0078|TWO_SIDED|95.0|-41.46|-6.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep onset latency||-6.33|-41.46|0.0078
91538007|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-25.49||||0.0052|TWO_SIDED|95.0|-43.3|-7.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep onset latency||-7.68|-43.30|0.0052
91538008|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-12.45||||0.2373|TWO_SIDED|95.0|-33.14|8.24|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep onset latency||8.24|-33.14|0.2373
91538009|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|1.75||||0.8707|TWO_SIDED|95.0|-19.38|22.87|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep onset latency||22.87|-19.38|0.8707
91538010|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-12.92||||0.1933|TWO_SIDED|95.0|-32.43|6.59|||Mixed Models Repeated Measures|||Placebo va GW823296 30 mg: Week 4, sleep onset latency||6.59|-32.43|0.1933
91538011|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-10.55||||0.2933|TWO_SIDED|95.0|-30.26|9.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep onset latency||9.17|-30.26|0.2933
91538012|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-28.58||||0.0177|TWO_SIDED|95.0|-52.15|-5.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep onset latency||-5.01|-52.15|0.0177
91538013|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-30.07||||0.0152|TWO_SIDED|95.0|-54.29|-5.84|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep onset latency||-5.84|-54.29|0.0152
91538014|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-17.19||||0.0108|TWO_SIDED|95.0|-30.36|-4.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset||-4.01|-30.36|0.0108
91538015|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-16.15||||0.019|TWO_SIDED|95.0|-29.61|-2.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset||-2.68|-29.61|0.0190
91538016|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|1.89||||0.8195|TWO_SIDED|95.0|-14.43|18.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset||18.21|-14.43|0.8195
91538017|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|5.27||||0.5327|TWO_SIDED|95.0|-11.35|21.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset||21.89|-11.35|0.5327
91538018|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-2.5||||0.7387|TWO_SIDED|95.0|-17.24|12.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset||12.25|-17.24|0.7387
91538019|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-9.44||||0.2134|TWO_SIDED|95.0|-24.35|5.48|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset||5.48|-24.35|0.2134
91538020|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-14.51||||0.1561|TWO_SIDED|95.0|-34.61|5.6|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset||5.60|-34.61|0.1561
91538021|NCT00880048|182954336|SUPERIORITY||Mean Difference (Net)|-17.1||||0.1054|TWO_SIDED|95.0|-37.84|3.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset||3.64|-37.84|0.1054
91538022|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|-0.57||||0.0024|TWO_SIDED|95.0|-0.94|-0.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.21|-0.94|0.0024
91538023|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6146|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.28|-0.47|0.6146
91538024|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|-0.25||||0.1442|TWO_SIDED|95.0|-0.59|0.09|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.09|-0.59|0.1442
91763280|NCT03726489|183417008|SUPERIORITY||Risk Difference (RD)|-0.011||||0.815|TWO_SIDED|95.0|-0.101|0.079|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 24. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.079|-0.101|0.815
91538025|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|0.04||||0.8001|TWO_SIDED|95.0|-0.3|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||0.39|-0.30|0.8001
91538026|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|-0.05||||0.8439|TWO_SIDED|95.0|-0.55|0.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.45|-0.55|0.8439
91763281|NCT00853151|183417009|SUPERIORITY_OR_OTHER|||||||0.623||90.0||||p-value is for LY2428757 plus TT223 3 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.623
91763282|NCT00853151|183417009|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||p-value is for LY2428757 plus TT223 2 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.809
91763283|NCT01510158|183417049|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.17|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.17|<0.0001
91763284|NCT01510158|183417049|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.22|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.22|<0.0001
91763285|NCT01510158|183417050|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.9796|TWO_SIDED|95.0|0.61|1.61|||Negative Binomial Regression|||||1.61|0.61|0.9796
91763286|NCT01510158|183417050|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.6125|TWO_SIDED|95.0|0.54|1.43|||Negative Binomial Regression|||||1.43|0.54|0.6125
91763287|NCT01510158|183417051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.29||||0.0183|TWO_SIDED|95.0|-0.51|-0.08|||Cochran-Mantel-Haenszel|||||-0.08|-0.51|0.0183
91763288|NCT01510158|183417051|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.5974|TWO_SIDED|95.0|-0.37|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.37|0.5974
91763289|NCT03078556|183417052|OTHER||Ratio|1.271|||||TWO_SIDED|90.0|1.1894|1.3582|||||Ratio (B/A) of plasma DTG has been presented.|||1.3582|1.1894|
91763290|NCT03078556|183417052|OTHER||Ratio|1.0341|||||TWO_SIDED|90.0|1.0097|1.0591|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0591|1.0097|
91763291|NCT03078556|183417053|OTHER||Ratio|1.155|||||TWO_SIDED|90.0|1.0699|1.2468|||||Ratio (C/A) of plasma DTG has been presented.|||1.2468|1.0699|
91763292|NCT03078556|183417053|OTHER||Ratio|1.0635|||||TWO_SIDED|90.0|1.0413|1.0861|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0861|1.0413|
91763293|NCT03078556|183417054|OTHER||Ratio|1.2756|||||TWO_SIDED|90.0|1.1919|1.3651|||||Ratio (B/A) of plasma DTG has been presented.|||1.3651|1.1919|
91763294|NCT03078556|183417054|OTHER||Ratio|1.0372|||||TWO_SIDED|90.0|1.0116|1.0634|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0634|1.0116|
91763295|NCT03078556|183417055|OTHER||Ratio|1.1578|||||TWO_SIDED|90.0|1.0718|1.2507|||||Ratio (C/A) of plasma DTG has been presented.|||1.2507|1.0718|
91763296|NCT03078556|183417055|OTHER||Ratio|1.0702|||||TWO_SIDED|90.0|1.0464|1.0946|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0946|1.0464|
91763297|NCT03078556|183417056|OTHER||Ratio|1.2805|||||TWO_SIDED|90.0|1.189|1.379|||||Ratio (B/A) of plasma DTG has been presented.|||1.3790|1.1890|
91763298|NCT03078556|183417056|OTHER||Ratio|1.1956|||||TWO_SIDED|90.0|1.1437|1.2498|||||Ratio (B/A) of plasma 3TC has been presented.|||1.2498|1.1437|
91763299|NCT03078556|183417057|OTHER||Ratio|1.141|||||TWO_SIDED|90.0|1.0533|1.2361|||||Ratio (C/A) of plasma DTG has been presented.|||1.2361|1.0533|
91763300|NCT03078556|183417057|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.2616|1.376|||||Ratio (C/A) of plasma 3TC has been presented.|||1.3760|1.2616|
91763301|NCT03078556|183417058|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|0.000|
91763302|NCT03078556|183417058|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
91763303|NCT03078556|183417059|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.004|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|-0.004|
91763304|NCT03078556|183417059|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
91763305|NCT03078556|183417060|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.5|0.248|||||Median Difference of plasma DTG has been presented.|||0.248|-0.500|
91763306|NCT03078556|183417060|OTHER||Median Difference (Final Values)|-0.126|||||TWO_SIDED|90.0|-0.253|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.253|
91763307|NCT03078556|183417061|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.497|0.132|||||Median Difference of plasma DTG has been presented.|||0.132|-0.497|
91763308|NCT03078556|183417061|OTHER||Median Difference (Final Values)|-0.248|||||TWO_SIDED|90.0|-0.376|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.376|
91763309|NCT03078556|183417070|OTHER||Ratio|1.2774|||||TWO_SIDED|90.0|1.1931|1.3676|||||Ratio (B/A) of plasma DTG has been presented.|||1.3676|1.1931|
91763310|NCT03078556|183417070|OTHER||Ratio|1.0475|||||TWO_SIDED|90.0|1.0185|1.0773|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0773|1.0185|
91763311|NCT03078556|183417071|OTHER||Ratio|1.1599|||||TWO_SIDED|90.0|1.0711|1.256|||||Ratio (C/A) of plasma DTG has been presented.|||1.2560|1.0711|
91763312|NCT03078556|183417071|OTHER||Ratio|1.0807|||||TWO_SIDED|90.0|1.0539|1.1081|||||Ratio (C/A) of plasma 3TC has been presented.|||1.1081|1.0539|
91763313|NCT03078556|183417072|OTHER||Ratio|0.7868|||||TWO_SIDED|90.0|0.7363|0.8408|||||Ratio (B/A) of plasma DTG has been presented.|||0.8408|0.7363|
91763314|NCT03078556|183417072|OTHER||Ratio|0.967|||||TWO_SIDED|90.0|0.9442|0.9904|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9904|0.9442|
91763315|NCT03078556|183417073|OTHER||Ratio|0.8658|||||TWO_SIDED|90.0|0.8021|0.9347|||||Ratio (C/A) of plasma DTG has been presented.|||0.9347|0.8021|
91763316|NCT03078556|183417073|OTHER||Ratio|0.9403|||||TWO_SIDED|90.0|0.9207|0.9604|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9604|0.9207|
91763317|NCT03078556|183417074|OTHER||Ratio|0.7859|||||TWO_SIDED|90.0|0.7318|0.844|||||Ratio (B/A) of plasma DTG has been presented.|||0.8440|0.7318|
91538027|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1259|TWO_SIDED|95.0|-0.91|0.11|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||0.11|-0.91|0.1259
91538028|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|0.2||||0.3709|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||0.64|-0.24|0.3709
91538029|NCT00880048|182954337|SUPERIORITY||Mean Difference (Net)|-0.24||||0.2993|TWO_SIDED|95.0|-0.7|0.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.22|-0.70|0.2993
91538030|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.59||||0.0344|TWO_SIDED|95.0|0.04|1.14|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep quality||1.14|0.04|0.0344
91538031|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.72||||0.0111|TWO_SIDED|95.0|0.17|1.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep quality||1.27|0.17|0.0111
91538032|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.42||||0.1443|TWO_SIDED|95.0|-0.15|0.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep quality||0.99|-0.15|0.1443
91538033|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.5||||0.0873|TWO_SIDED|95.0|-0.07|1.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep quality||1.08|-0.07|0.0873
91538034|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.73||||0.017|TWO_SIDED|95.0|0.13|1.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, sleep quality||1.33|0.13|0.0170
91538035|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.42||||0.1675|TWO_SIDED|95.0|-0.18|1.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep quality||1.02|-0.18|0.1675
91763318|NCT03078556|183417074|OTHER||Ratio|0.9704|||||TWO_SIDED|90.0|0.9157|1.0284|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0284|0.9157|
91538036|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.56||||0.0956|TWO_SIDED|95.0|-0.1|1.23|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep quality||1.23|-0.10|0.0956
91538037|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.32||||0.3503|TWO_SIDED|95.0|-0.35|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep quality||1.00|-0.35|0.3503
91538038|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.34||||0.2147|TWO_SIDED|95.0|-0.2|0.88|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep||0.88|-0.20|0.2147
91763319|NCT03078556|183417075|OTHER||Ratio|0.8571|||||TWO_SIDED|90.0|0.7914|0.9282|||||Ratio (C/A) of plasma DTG has been presented.|||0.9282|0.7914|
91763320|NCT03078556|183417075|OTHER||Ratio|0.9153|||||TWO_SIDED|90.0|0.8613|0.9728|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9728|0.8613|
91538039|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.63||||0.0233|TWO_SIDED|95.0|0.09|1.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep||1.17|0.09|0.0233
91538040|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.33||||0.2404|TWO_SIDED|95.0|-0.22|0.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep||0.89|-0.22|0.2404
91763321|NCT03078556|183417076|OTHER||Ratio|1.2632|||||TWO_SIDED|90.0|1.1811|1.3511|||||Ratio (B/A) of plasma DTG has been presented.|||1.3511|1.1811|
91763322|NCT03078556|183417076|OTHER||Ratio|0.9598|||||TWO_SIDED|90.0|0.9268|0.9941|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9941|0.9268|
91763323|NCT03078556|183417077|OTHER||Ratio|1.1425|||||TWO_SIDED|90.0|1.0597|1.2317|||||Ratio (C/A) of plasma DTG has been presented.|||1.2317|1.0597|
91538041|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.65||||0.0247|TWO_SIDED|95.0|0.08|1.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep||1.22|0.08|0.0247
91538042|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.69||||0.0271|TWO_SIDED|95.0|0.08|1.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep||1.29|0.08|0.0271
91538043|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.39||||0.2129|TWO_SIDED|95.0|-0.22|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, refreshing value of sleep||1.00|-0.22|0.2129
91538044|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.37||||0.2874|TWO_SIDED|95.0|-0.31|1.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, refreshing value of sleep||1.06|-0.31|0.2874
91538045|NCT00880048|182954338|SUPERIORITY||Mean Difference (Net)|0.71||||0.0472|TWO_SIDED|95.0|0.01|1.41|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, refreshing value of sleep||1.41|0.01|0.0472
91538046|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9824|TWO_SIDED|95.0|0.13|7.09|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 1||7.09|0.13|0.9824
91763324|NCT03078556|183417077|OTHER||Ratio|0.9548|||||TWO_SIDED|90.0|0.9299|0.9804|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9804|0.9299|
91763325|NCT03078556|183417078|OTHER||Ratio|1.1839|||||TWO_SIDED|90.0|1.0921|1.2834|||||Ratio (B/A) of plasma DTG has been presented|||1.2834|1.0921|
91763326|NCT03078556|183417078|OTHER||Ratio|0.8874|||||TWO_SIDED|90.0|0.834|0.9443|||||Ratio (B/A) of plasma 3TC has been presented|||0.9443|0.8340|
91538047|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|0.54||||0.6227|TWO_SIDED|95.0|0.05|6.13|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 1||6.13|0.05|0.6227
91538048|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9967|TWO_SIDED|95.0|0.2|5.07|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 2||5.07|0.20|0.9967
91538049|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|2.0||||0.355|TWO_SIDED|95.0|0.46|8.63|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 2||8.63|0.46|0.3550
91538050|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1009|TWO_SIDED|95.0|0.85|6.49|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 4||6.49|0.85|0.1009
91538051|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0455|TWO_SIDED|95.0|1.02|7.68|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 4||7.68|1.02|0.0455
91538052|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0507|TWO_SIDED|95.0|1.0|5.32|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 6||5.32|1.00|0.0507
91538053|NCT00880048|182954339|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4962|TWO_SIDED|95.0|0.55|3.45|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 6||3.45|0.55|0.4962
91538054|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|1.03||||0.3241|TWO_SIDED|95.0|-1.03|3.1|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||3.10|-1.03|0.3241
91538055|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|-0.56||||0.602|TWO_SIDED|95.0|-2.66|1.55|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.55|-2.66|0.6020
91763327|NCT03078556|183417079|OTHER||Ratio|1.078|||||TWO_SIDED|90.0|0.9958|1.167|||||Ratio (B/A) of plasma DTG has been presented|||1.1670|0.9958|
91763328|NCT03078556|183417079|OTHER||Ratio|0.9049|||||TWO_SIDED|90.0|0.8474|0.9663|||||Ratio (B/A) of plasma 3TC has been presented|||0.9663|0.8474|
91763329|NCT03078556|183417080|OTHER||Ratio|1.1545|||||TWO_SIDED|90.0|1.0208|1.3058|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.3058|1.0208|
91763330|NCT03078556|183417080|OTHER||Ratio|0.9577|||||TWO_SIDED|90.0|0.9126|1.0049|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0049|0.9126|
91763331|NCT03078556|183417081|OTHER||Ratio|1.3256|||||TWO_SIDED|90.0|1.1837|1.4845|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4845|1.1837|
91763332|NCT03078556|183417081|OTHER||Ratio|0.9114|||||TWO_SIDED|90.0|0.8658|0.9593|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9593|0.8658|
91763333|NCT03078556|183417082|OTHER||Ratio|1.1481|||||TWO_SIDED|90.0|1.0154|1.2982|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2982|1.0154|
91763334|NCT03078556|183417082|OTHER||Ratio|0.9524|||||TWO_SIDED|90.0|0.9086|0.9983|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9983|0.9086|
91763335|NCT03078556|183417083|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.175|1.4775|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4775|1.1750|
91763336|NCT03078556|183417083|OTHER||Ratio|0.9048|||||TWO_SIDED|90.0|0.8592|0.9528|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9528|0.8592|
91763337|NCT03078556|183417084|OTHER||Ratio|1.0808|||||TWO_SIDED|90.0|0.9527|1.2261|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2261|0.9527|
91763338|NCT03078556|183417084|OTHER||Ratio|0.7097|||||TWO_SIDED|90.0|0.6474|0.7779|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.7779|0.6474|
91763339|NCT03078556|183417085|OTHER||Ratio|1.2096|||||TWO_SIDED|90.0|1.0521|1.3908|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.3908|1.0521|
91763340|NCT03078556|183417085|OTHER||Ratio|0.6826|||||TWO_SIDED|90.0|0.5861|0.795|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.7950|0.5861|
91763341|NCT03078556|183417086|OTHER||Median Difference (Final Values)|0.254|||||TWO_SIDED|90.0|0.25|0.378|||||Median Difference of plasma DTG has been presented|||0.378|0.250|
91763342|NCT03078556|183417086|OTHER||Median Difference (Final Values)|0.125|||||TWO_SIDED|90.0|0.0|0.127|||||Median Difference of plasma 3TC has been presented|||0.127|0.000|
91763343|NCT03078556|183417087|OTHER||Median Difference (Final Values)|0.126|||||TWO_SIDED|90.0|0.0|0.25|||||Median Difference of plasma DTG has been presented|||0.250|0.000|
91763344|NCT03078556|183417087|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.125|||||Median Difference of plasma 3TC has been presented|||0.125|0.000|
91763345|NCT03078556|183417088|OTHER||Median Difference (Final Values)|3.017|||||TWO_SIDED|90.0|1.872|4.496|||||Median Difference of plasma DTG has been presented|||4.496|1.872|
91763346|NCT03078556|183417088|OTHER||Median Difference (Final Values)|2.113|||||TWO_SIDED|90.0|1.5|2.751|||||Median Difference of plasma 3TC has been presented|||2.751|1.500|
91763347|NCT03078556|183417089|OTHER||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|1.748|3.751|||||Median Difference of plasma DTG has been presented|||3.751|1.748|
91763348|NCT03078556|183417089|OTHER||Median Difference (Final Values)|1.503|||||TWO_SIDED|90.0|0.998|2.252|||||Median Difference of plasma 3TC has been presented|||2.252|0.998|
91538056|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|2.44||||0.0594|TWO_SIDED|95.0|-0.1|4.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||4.99|-0.10|0.0594
91763349|NCT03078556|183417098|OTHER||Ratio|1.0849|||||TWO_SIDED|90.0|0.9613|1.2245|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2245|0.9613|
91763350|NCT03078556|183417098|OTHER||Ratio|0.9363|||||TWO_SIDED|90.0|0.8913|0.9836|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9836|0.8913|
91763351|NCT03078556|183417099|OTHER||Median Difference (Final Values)|1.2477|||||TWO_SIDED|90.0|1.1013|1.4136|||||Median Difference of plasma DTG has been presented|||1.4136|1.1013|
91763352|NCT03078556|183417099|OTHER||Median Difference (Final Values)|0.8836|||||TWO_SIDED|90.0|0.8351|0.935|||||Median Difference of plasma 3TC has been presented|||0.9350|0.8351|
91763353|NCT03078556|183417100|OTHER||Ratio|0.8661|||||TWO_SIDED|90.0|0.7658|0.9796|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9796|0.7658|
91763354|NCT03078556|183417100|OTHER||Ratio|1.0442|||||TWO_SIDED|90.0|0.9951|1.0957|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0957|0.9951|
91763355|NCT03078556|183417101|OTHER||Ratio|0.7544|||||TWO_SIDED|90.0|0.6736|0.8448|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8448|0.6736|
91763356|NCT03078556|183417101|OTHER||Ratio|1.0972|||||TWO_SIDED|90.0|1.0424|1.155|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.1550|1.0424|
91763357|NCT03078556|183417104|OTHER||Ratio|0.8654|||||TWO_SIDED|90.0|0.7629|0.9816|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9816|0.7629|
91763358|NCT03078556|183417104|OTHER||Ratio|1.0841|||||TWO_SIDED|90.0|0.9139|1.286|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.2860|0.9139|
91763359|NCT03078556|183417105|OTHER||Ratio|0.7657|||||TWO_SIDED|90.0|0.6702|0.8749|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8749|0.6702|
91538057|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|0.92||||0.4828|TWO_SIDED|95.0|-1.67|3.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||3.50|-1.67|0.4828
91763360|NCT03078556|183417105|OTHER||Ratio|1.197|||||TWO_SIDED|90.0|1.0869|1.3182|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.3182|1.0869|
91538058|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|0.19||||0.9008|TWO_SIDED|95.0|-2.8|3.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||3.18|-2.80|0.9008
91763361|NCT03078556|183417106|OTHER||Ratio|1.2929|||||TWO_SIDED|90.0|1.1281|1.4819|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.4819|1.1281|
91763362|NCT03078556|183417106|OTHER||Ratio|1.2015|||||TWO_SIDED|90.0|1.1074|1.3036|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.3036|1.1074|
91763363|NCT03078556|183417107|OTHER||Ratio|1.469|||||TWO_SIDED|90.0|1.3009|1.6588|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.6588|1.3009|
91763364|NCT03078556|183417107|OTHER||Ratio|1.1935|||||TWO_SIDED|90.0|1.1142|1.2785|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.2785|1.1142|
91763365|NCT01466127|183417131|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
91763366|NCT00571038|183417132|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Mixed Models Analysis|||||||0.2417
91763367|NCT00571038|183417133|SUPERIORITY_OR_OTHER|||||||0.8586|TWO_SIDED||||||Mixed Models Analysis|||||||0.8586
91763368|NCT00571038|183417134|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Mixed Models Analysis|||||||0.0432
91763369|NCT00571038|183417135|SUPERIORITY_OR_OTHER|||||||0.0604|TWO_SIDED||||||Mixed Models Analysis|||||||0.0604
91763370|NCT00571038|183417136|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Kruskal-Wallis|||||||0.0438
91763371|NCT00571038|183417137|SUPERIORITY_OR_OTHER|||||||0.1418|TWO_SIDED||||||Kruskal-Wallis|||||||0.1418
91538059|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|-0.71||||0.6428|TWO_SIDED|95.0|-3.74|2.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||2.32|-3.74|0.6428
91538060|NCT00880048|182954342|SUPERIORITY||Mean Difference (Net)|-0.68||||0.6911|TWO_SIDED|95.0|-4.06|2.7|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||2.70|-4.06|0.6911
91538061|NCT00880048|182954342|SUPERIORITY||Odds Ratio (OR)|-0.67||||0.7026|TWO_SIDED|95.0|-4.14|2.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.80|-4.14|0.7026
91538062|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|-0.97||||0.1301|TWO_SIDED|95.0|-2.24|0.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||0.29|-2.24|0.1301
91538063|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|0.47||||0.4644|TWO_SIDED|95.0|-0.79|1.73|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.73|-0.79|0.4644
91538064|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|-0.76||||0.3382|TWO_SIDED|95.0|-2.33|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.80|-2.33|0.3382
91538065|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|0.94||||0.241|TWO_SIDED|95.0|-0.63|2.51|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||2.51|-0.63|0.2410
91763372|NCT00571038|183417138|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|Two-sided Pr \<= P||||||0.0070
91763373|NCT00571038|183417139|SUPERIORITY_OR_OTHER|||||||0.8395|TWO_SIDED||||||Kruskal-Wallis|||||||0.8395
91763374|NCT00571038|183417140|SUPERIORITY_OR_OTHER|||||||0.2194|TWO_SIDED||||||Kruskal-Wallis|||||||0.2194
91538066|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|-0.98||||0.2768|TWO_SIDED|95.0|-2.75|0.79|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.79|-2.75|0.2768
91538067|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|0.06||||0.9434|TWO_SIDED|95.0|-1.7|1.83|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.83|-1.70|0.9434
91763375|NCT00571038|183417141|SUPERIORITY_OR_OTHER|||||||0.9191|TWO_SIDED||||||Kruskal-Wallis|||||||0.9191
91763376|NCT00571038|183417142|SUPERIORITY_OR_OTHER|||||||0.9633|TWO_SIDED||||||Kruskal-Wallis|||||||0.9633
91763377|NCT00571038|183417143|SUPERIORITY_OR_OTHER|||||||0.5901|TWO_SIDED||||||Kruskal-Wallis|||||||0.5901
91538068|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|-0.55||||0.5796|TWO_SIDED|95.0|-2.49|1.4|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.40|-2.49|0.5796
91763378|NCT00571038|183417144|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Kruskal-Wallis|||||||0.9820
91538069|NCT00880048|182954343|SUPERIORITY||Mean Difference (Net)|0.71||||0.4753|TWO_SIDED|95.0|-1.24|2.66|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.66|-1.24|0.4753
91538070|NCT02914522|182954372|SUPERIORITY||Difference in Percentages|10.8||||0.0157|TWO_SIDED|95.0|2.1|19.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.||||19.5|2.1|0.0157
91538071|NCT02914522|182954372|SUPERIORITY||Difference in Percentages|3.8||||0.3379|TWO_SIDED|95.0|-4.3|12.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.0|-4.3|0.3379
91538072|NCT02914522|182954372|SUPERIORITY||Difference in Percentages|7.2||||0.0103|TWO_SIDED|95.0|1.6|12.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||12.8|1.6|0.0103
91538073|NCT02914522|182954372|SUPERIORITY||Difference in Percentages|5.2||||0.0645|TWO_SIDED|95.0|0.0|10.5|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.5|-0.0|0.0645
91538074|NCT02914522|182954373|SUPERIORITY||Difference in Percentages|26.0|||<|0.0001|TWO_SIDED|95.0|16.0|35.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.9|16.0|< 0.0001
91763379|NCT00571038|183417145|SUPERIORITY_OR_OTHER|||||||0.3979|TWO_SIDED||||||Kruskal-Wallis|||||||0.3979
91763380|NCT00571038|183417146|SUPERIORITY_OR_OTHER|||||||0.1471|TWO_SIDED||||||Kruskal-Wallis|||||||0.1471
91763381|NCT00571038|183417147|SUPERIORITY_OR_OTHER|||||||0.6123|TWO_SIDED||||||Kruskal-Wallis|||||||0.6123
91763382|NCT00571038|183417148|SUPERIORITY_OR_OTHER|||||||0.5861|TWO_SIDED||||||Kruskal-Wallis|||||||0.5861
91763383|NCT00571038|183417149|SUPERIORITY_OR_OTHER|||||||0.4489|TWO_SIDED||||||Kruskal-Wallis|||||||0.4489
91763384|NCT00571038|183417150|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||Kruskal-Wallis|||||||0.2527
91763385|NCT00571038|183417151|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Kruskal-Wallis|||||||0.7314
91763386|NCT00571038|183417152|SUPERIORITY_OR_OTHER|||||||0.9839|TWO_SIDED||||||Kruskal-Wallis|||||||0.9839
91763387|NCT02588261|183417181|SUPERIORITY||Hazard Ratio (HR)|1.611||||0.992|TWO_SIDED|95.0|1.086|2.391|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.391|1.086|0.992
91763388|NCT02588261|183417183|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||1.000
91763389|NCT02588261|183417184|SUPERIORITY||Hazard Ratio (HR)|1.674||||0.998|TWO_SIDED|95.0|1.165|2.406|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.406|1.165|0.998
91538075|NCT02914522|182954373|SUPERIORITY||Difference in Percentages|10.4||||0.042|TWO_SIDED|95.0|0.0|20.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.7|-0.0|0.0420
91538076|NCT02914522|182954374|SUPERIORITY||Difference in Percentages|12.1||||0.0053|TWO_SIDED|95.0|3.8|20.4|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||20.4|3.8|0.0053
91538077|NCT02914522|182954374|SUPERIORITY||Difference in Percentages|4.6||||0.2295|TWO_SIDED|95.0|-3.1|12.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.2|-3.1|0.2295
91538078|NCT02914522|182954374|SUPERIORITY||Difference in Percentages|5.3||||0.0393|TWO_SIDED|95.0|-0.1|10.7|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.7|-0.1|0.0393
91538079|NCT02914522|182954374|SUPERIORITY||Difference in Percentages|1.7||||0.5308|TWO_SIDED|95.0|-3.1|6.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||6.6|-3.1|0.5308
91538080|NCT02914522|182954375|SUPERIORITY||Difference in Percentages|8.6||||0.0047|TWO_SIDED|95.0|2.9|14.3|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||14.3|2.9|0.0047
91538081|NCT02914522|182954375|SUPERIORITY||Difference in Percentages|2.1||||0.3495|TWO_SIDED|95.0|-2.6|6.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||6.8|-2.6|0.3495
91538082|NCT02914522|182954375|SUPERIORITY||Difference in Percentages|1.3||||0.4269|TWO_SIDED|95.0|-2.5|5.1|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.1|-2.5|0.4269
91538083|NCT02914522|182954375|SUPERIORITY||Difference in Percentages|0.0||||0.9987|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9987
91538084|NCT02914522|182954376|SUPERIORITY||Difference in Percentages|19.0|||<|0.0001|TWO_SIDED|95.0|9.9|28.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||28.2|9.9|<0.0001
91538085|NCT02914522|182954376|SUPERIORITY||Difference in Percentages|7.8||||0.0672|TWO_SIDED|95.0|-0.7|16.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||16.2|-0.7|0.0672
91538086|NCT02914522|182954376|SUPERIORITY||Difference in Percentages|11.4||||0.0019|TWO_SIDED|95.0|4.2|18.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||18.6|4.2|0.0019
91538087|NCT02914522|182954376|SUPERIORITY||Difference in Percentages|5.2||||0.1286|TWO_SIDED|95.0|-1.4|11.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||11.8|-1.4|0.1286
91538088|NCT02914522|182954377|SUPERIORITY||Difference in Percentages|7.9||||0.0105|TWO_SIDED|95.0|1.9|13.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||13.8|1.9|0.0105
91538089|NCT02914522|182954377|SUPERIORITY||Difference in Percentages|4.3||||0.1062|TWO_SIDED|95.0|-1.0|9.6|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||9.6|-1.0|0.1062
91538090|NCT02914522|182954377|SUPERIORITY||Difference in Percentages|1.7||||0.3084|TWO_SIDED|95.0|-2.2|5.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.6|-2.2|0.3084
91538091|NCT02914522|182954377|SUPERIORITY||Difference in Percentages|0.0||||0.9109|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9109
91538092|NCT02914522|182954383|SUPERIORITY||Difference in Percentages|25.5|||<|0.0001|TWO_SIDED|95.0|16.0|35.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.0|16.0|<0.0001
91538093|NCT02914522|182954383|SUPERIORITY||Difference in Percentages|9.2||||0.0658|TWO_SIDED|95.0|-1.1|19.5|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||19.5|-1.1|0.0658
91538094|NCT02914522|182954384|SUPERIORITY||Difference in Percentages|13.0||||0.0024|TWO_SIDED|95.0|5.3|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|5.3|0.0024
91538095|NCT02914522|182954384|SUPERIORITY||Difference in Percentages|0.9||||0.7951|TWO_SIDED|95.0|-7.0|8.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||8.7|-7.0|0.7951
91538096|NCT02914522|182954385|SUPERIORITY||Difference in Percentages|20.8||||0.0055|TWO_SIDED|95.0|7.7|33.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||33.9|7.7|0.0055
91538097|NCT02914522|182954385|SUPERIORITY||Difference in Percentages|8.2||||0.1265|TWO_SIDED|95.0|-4.2|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|-4.2|0.1265
91538098|NCT02914522|182954386|SUPERIORITY||Difference in Percentages|9.5||||0.0157|TWO_SIDED|95.0|1.8|17.1|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||17.1|1.8|0.0157
91538099|NCT02914522|182954386|SUPERIORITY||Difference in Percentages|5.5||||0.1808|TWO_SIDED|95.0|-2.9|13.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||13.9|-2.9|0.1808
91538100|NCT02914522|182954387|SUPERIORITY||Difference in Percentages|24.9|||<|0.0001|TWO_SIDED|95.0|14.6|35.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.2|14.6|<0.0001
91538101|NCT02914522|182954387|SUPERIORITY||Difference in Percentages|9.9||||0.0521|TWO_SIDED|95.0|-1.3|21.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||21.2|-1.3|0.0521
91538102|NCT02914522|182954388|SUPERIORITY||Difference in Percentages|16.0||||0.0005|TWO_SIDED|95.0|7.8|24.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||24.2|7.8|0.0005
91538103|NCT02914522|182954388|SUPERIORITY||Difference in Percentages|4.3||||0.2946|TWO_SIDED|95.0|-3.9|12.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||12.6|-3.9|0.2946
91538104|NCT03368001|182954413|OTHER|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses. We accounted for any non-independence of observations due to cohort membership by obtaining cluster-robust standard errors using robust maximum likelihood estimation (MLR in Mplus) in tandem with the Type = Complex option available in Mplus, treating cohorts as clusters. All models were structurally saturated, so model fit was necessarily perfect.||||||0.039||||||IFM Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Population models were specified using parameter values derived from past research in tandem with minimal expected effect sizes for the effects of most interest. These models were used to generate 5000 samples for a given N, the models were fit to each sample, and the significance (or not) of key effects was noted. This process was repeated until the target power of at least .80 was reached indicating with 216 participants we would have .82 power.||||.039
91763390|NCT02588261|183417185|SUPERIORITY|||||||0.839|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||0.839
91763391|NCT02588261|183417186|SUPERIORITY||Hazard Ratio (HR)|1.298||||0.78|TWO_SIDED|95.0|0.661|2.548|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.548|0.661|0.780
91763392|NCT02287467|183417199|SUPERIORITY||Odds Ratio (OR)|1.25||||0.33|TWO_SIDED|95.0|0.79|1.97|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.|Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.||1.97|0.79|.33
91763393|NCT02287467|183417200|SUPERIORITY||Odds Ratio (OR)|0.95||||0.84|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.|Odds ratio for being in a better category, from a proportional odds model||1.48|0.61|.84
91763394|NCT02287467|183417201|SUPERIORITY||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Regression, Cox|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs. placebo. An odds ratio \> 1 favors the hIVIG group.|Odds ratio for being in a better group, from a proportional odds model.||1.33|0.57|.52
91763395|NCT02287467|183417202|SUPERIORITY||Odds Ratio (OR)|1.49||||0.2|TWO_SIDED|95.0|0.81|2.74|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio for hIVIG vs placebo. An odds ratio \> 1.0 favors the hIVIG group.|||2.74|0.81|.20
91763396|NCT02287467|183417203|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.44|TWO_SIDED|95.0|0.85|1.45|||Regression, Cox|Stratified by baseline clinical status, region, and participation in the pilot study.|hazard ratio is hIVIG vs placebo; a hazard ratio \>1 favors the hIVIG group.|Deaths during hospitalization are censored after day 7.||1.45|.85|.44
91538105|NCT03368001|182954413|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator.|Structural Equation Model (SEM)|0.064|||<|0.05|TWO_SIDED|90.0|0.014|0.118||One-tailed significance test|Structural Equation Model (SEM)|Controlling for Verbal Expressiveness at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.118|0.014|<0.05
91538106|NCT03368001|182954413|OTHER|The residual associated with the mediator was allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.032|||<|0.05|TWO_SIDED|90.0|0.002|0.087||One-sided hypothesis test.|Structural Equation Model (SEM)|Controlling for Rapport at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome.||0.087|0.002|<0.05
91538107|NCT03368001|182954413|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.005|||>|0.05|TWO_SIDED|90.0|-0.015|0.059||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for Social Anxiety at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.059|-0.015|>0.05
91538108|NCT03368001|182954413|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|-0.0002|||>|0.05|TWO_SIDED|90.0|-0.054|0.061||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for SRS-2 Social Communication at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.061|-0.054|>0.05
91538109|NCT03368001|182954414|OTHER|||||||0.49||||||SRS Communication Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||||||.490
91538110|NCT03368001|182954415|OTHER|Posttest ANCOVA controlling for pre-test scores||||||0.704|||||||ANCOVA|||||||0.704
91538111|NCT03368001|182954415|OTHER|Followup ANCOVA controlling for pretest values||||||0.406|||||||ANCOVA|||||||0.406
91538112|NCT03368001|182954416|OTHER|||||||0.217|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Vocal Expressiveness Posttest.||||.217
91538113|NCT03368001|182954416|OTHER|||||||0.448|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Quality of Rapport Posttest.||||.448
91538114|NCT03368001|182954416|OTHER|||||||0.15|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Social Anxiety Posttest.||||.150
91538115|NCT03368001|182954417|OTHER|Posttest ANCOVA controlling for pre-test values||||||0.169|||||||ANCOVA|||||||0.169
91538116|NCT03368001|182954417|OTHER|Followup ANCOVA controlling for pretest values.||||||0.555|||||||ANCOVA|||||||0.555
91538117|NCT03612804|182954418|SUPERIORITY||Odds Ratio (OR)|1.05||||0.83|TWO_SIDED|95.0|0.67|1.64||P-value not adjusted for multiple comparisons. A priori threshold for statistical significance was 0.05.|Regression, Logistic|Logistic regression model with random intercept for provider and main effect term for study site.|Proactive care arm represents numerator of odds ratio, unstructured care arm represents denominator of odds ratio.|||1.64|0.67|0.83
91538118|NCT03105128|182954436|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
91538119|NCT03105128|182954436|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
91538120|NCT03105128|182954437|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
91538121|NCT03105128|182954437|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
91538122|NCT03105128|182954438|SUPERIORITY||Adjusted Risk Difference|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
91538123|NCT03105128|182954438|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
91538124|NCT03105128|182954439|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
91538125|NCT03105128|182954439|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
91538126|NCT03105128|182954440|SUPERIORITY||Risk Difference (RD)|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
91538127|NCT03105128|182954440|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
91538128|NCT03105128|182954441|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
91538129|NCT03105128|182954441|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
91538130|NCT03105128|182954442|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
91538131|NCT03105128|182954442|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
91538132|NCT03105128|182954443|SUPERIORITY||Adjusted Risk Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Cochran-Mantel-Haenszel|||||7.2|3.2|<0.001
91538133|NCT03105128|182954443|SUPERIORITY||Adjusted Risk Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Cochran-Mantel-Haenszel|||||6.1|2.1|<0.001
91538134|NCT03105128|182954444|SUPERIORITY||Adjusted Risk Difference|7.6||||0.015|TWO_SIDED|95.0|1.5|13.7|||Cochran-Mantel-Haenszel|||||13.7|1.5|0.015
91538135|NCT03105128|182954444|SUPERIORITY||Adjusted Risk Difference|8.4||||0.007|TWO_SIDED|95.0|2.3|14.6|||Cochran-Mantel-Haenszel|||||14.6|2.3|0.007
91538136|NCT03105128|182954445|SUPERIORITY||Adjusted Risk Difference|24.5|||<|0.001|TWO_SIDED|95.0|18.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|18.5|<0.001
91538137|NCT03105128|182954445|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|11.8|22.9|||Cochran-Mantel-Haenszel|||||22.9|11.8|<0.001
91538138|NCT03105128|182954446|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.001|TWO_SIDED|95.0|15.7|32.7|||Cochran-Mantel-Haenszel|||||32.7|15.7|<0.001
91538139|NCT03105128|182954446|SUPERIORITY||Adjusted Risk Difference|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1|||Cochran-Mantel-Haenszel|||||32.1|15.1|<0.001
91538140|NCT03105128|182954447|SUPERIORITY||Adjusted Risk Difference|21.2|||<|0.001|TWO_SIDED|95.0|12.4|30.0|||Cochran-Mantel-Haenszel|||||30.0|12.4|<0.001
91538141|NCT03105128|182954447|SUPERIORITY||Adjusted Risk Difference|19.0|||<|0.001|TWO_SIDED|95.0|10.1|27.8|||Cochran-Mantel-Haenszel|||||27.8|10.1|<0.001
91538142|NCT03105128|182954448|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
91538143|NCT03105128|182954448|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
91538144|NCT03105128|182954449|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
91538145|NCT03105128|182954449|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
91538146|NCT03105128|182954450|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
91538147|NCT03105128|182954450|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
91538148|NCT03105128|182954451|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
91538149|NCT03105128|182954451|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
91538150|NCT03105128|182954452|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
91538151|NCT03105128|182954452|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
91538152|NCT03105128|182954453|SUPERIORITY||Risk Difference (RD)|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Chi-squared|||||-3.5|-13.9|<0.001
91538153|NCT03105128|182954453|SUPERIORITY||Risk Difference (RD)|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Chi-squared|||||-5.2|-15.2|<0.001
91538154|NCT03105128|182954454|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Chi-squared|||||39.7|-28.6|1.00
91538155|NCT03105128|182954454|SUPERIORITY||Risk Difference (RD)|6.9||||1|TWO_SIDED|25.0|-25.7|39.6|||Chi-squared|||||39.6|-25.7|1.000
91538156|NCT03105128|182954455|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
91538157|NCT03105128|182954455|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
91538158|NCT03105128|182954456|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
91538159|NCT03105128|182954456|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
91538160|NCT03105128|182954457|SUPERIORITY||Adjusted Risk Difference|11.5|||<|0.001|TWO_SIDED|95.0|5.4|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.4|<0.001
91538161|NCT03105128|182954457|SUPERIORITY||Adjusted Risk Difference|11.7|||<|0.001|TWO_SIDED|95.0|5.7|17.8|||Cochran-Mantel-Haenszel|||||17.8|5.7|<0.001
91538162|NCT03105128|182954458|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
91538163|NCT03105128|182954458|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
91538164|NCT03105128|182954459|SUPERIORITY||LS Mean Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Mixed-Effect Model Repeat Measurement|||||7.2|3.2|<0.001
91538165|NCT03105128|182954459|SUPERIORITY||LS Mean Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Mixed-Effect Model Repeat Measurement|||||6.1|2.1|<0.001
91538166|NCT03105128|182954460|SUPERIORITY||LS Mean Difference|20.7|||<|0.001|TWO_SIDED|95.0|14.3|27.1|||Mixed-Effect Model Repeat Measurement|||||27.1|14.3|<0.001
91538167|NCT03105128|182954460|SUPERIORITY||LS Mean Difference|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8|||Mixed-Effect Model Repeat Measurement|||||25.8|13.1|<0.001
91538168|NCT03105128|182954461|SUPERIORITY||Adjusted Risk Difference|23.2|||<|0.001|TWO_SIDED|95.0|16.8|29.6|||Cochran-Mantel-Haenszel|||||29.6|16.8|<0.001
91538169|NCT03105128|182954461|SUPERIORITY||Adjusted Risk Difference|15.2|||<|0.001|TWO_SIDED|95.0|9.3|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.3|<0.001
91538170|NCT03105128|182954462|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
91538171|NCT03105128|182954462|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
91538172|NCT03105128|182954463|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
91538173|NCT03105128|182954463|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
91538174|NCT03105128|182954464|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
91538175|NCT03105128|182954464|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
91538176|NCT03105128|182954465|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
91538177|NCT03105128|182954465|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
91538178|NCT03105128|182954466|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
91538179|NCT03105128|182954466|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
91538180|NCT03105128|182954467|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Mixed-Effect Model Repeat Measurement|||||-3.5|-13.9|<0.001
91538181|NCT03105128|182954467|SUPERIORITY||LS Mean Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Mixed-Effect Model Repeat Measurement|||||-5.2|-15.2|<0.001
91538182|NCT03105128|182954468|SUPERIORITY||LS Mean Difference|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Mixed-Effect Model Repeat Measurement|||||39.7|-28.6|1.000
91538183|NCT03105128|182954468|SUPERIORITY||LS Mean Difference|6.9||||1|TWO_SIDED|95.0|-25.7|39.6|||Mixed-Effect Model Repeat Measurement|||||39.6|-25.7|1.000
91538184|NCT03105128|182954469|SUPERIORITY||LS Mean Difference|-9.586||||0.024|TWO_SIDED|95.0|-17.89|-1.282|||Mixed-Effect Model Repeat Measurement|||||-1.282|-17.890|0.024
91538185|NCT03105128|182954469|SUPERIORITY||LS Mean Difference|-12.141||||0.004|TWO_SIDED|95.0|-20.39|-3.892|||Mixed-Effect Model Repeat Measurement|||||-3.892|-20.390|0.004
91538186|NCT03105128|182954470|SUPERIORITY||LS Mean Difference|2.913|||<|0.001|TWO_SIDED|95.0|1.512|4.313|||Mixed-Effect Model Repeat Measurement|||||4.313|1.512|<0.001
91538187|NCT03105128|182954470|SUPERIORITY||LS Mean Difference|3.275|||<|0.001|TWO_SIDED|95.0|1.877|4.672|||Mixed-Effect Model Repeat Measurement|||||4.672|1.877|<0.001
91538188|NCT04391309|182954486|SUPERIORITY|||||||0.435|||||||Log Rank|||||||0.435
91538189|NCT04391309|182954487|SUPERIORITY|||||||1|||||||Fisher Exact|||All categories included in the analysis||||1
91538190|NCT04391309|182954488|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
91538191|NCT04391309|182954489|SUPERIORITY|||||||0.895|||||||Wilcoxon (Mann-Whitney)|||||||0.895
91538192|NCT04391309|182954490|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||||||0.702
91538193|NCT04391309|182954491|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
91538194|NCT04391309|182954492|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis||||1
91538195|NCT04391309|182954493|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the anlysis.||||1
91538196|NCT04391309|182954494|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
91538197|NCT04391309|182954495|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
91538198|NCT04391309|182954496|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
91538199|NCT04391309|182954497|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
91538200|NCT05826431|182954501|OTHER||Mean Difference (Final Values)|18.65||||0.153|TWO_SIDED||||||Paired samples t-test|||Study analyses were conducted using IBM SPSS Statistics Version 29. Frequencies and descriptive data were tabulated to describe the sample and quantify device use, satisfaction, and perceived impact. Qualitative responses regarding usability and feasibility were summarized based on the themes of the responses.||||0.153
91538201|NCT05826431|182954502|OTHER||Mean Difference (Final Values)|0.61||||0.103|TWO_SIDED||||||Paired samples t-test|||||||0.103
91538202|NCT05826431|182954504|OTHER|Single group, frequencies, and descriptive data|Mean Difference (Final Values)|4.22||||0.083|TWO_SIDED||||||Paired samples t-test|||||||.083
91538203|NCT05826431|182954505|OTHER||Mean Difference (Final Values)|-0.26||||441|TWO_SIDED||||||Paired samples t-test|||||||0441
91538204|NCT05826431|182954506|OTHER||Mean Difference (Final Values)|2.61||||0.095|TWO_SIDED||||||Paired samples t-test|||||||0.095
91538205|NCT05826431|182954507|OTHER||Mean Difference (Final Values)|0.03||||0.487|TWO_SIDED||||||Paired samples t-test|||||||0.487
91538206|NCT05826431|182954508|OTHER||Mean Difference (Final Values)|-0.06||||0.483|TWO_SIDED||||||Paired samples t-test|||||||0.483
91538207|NCT05826431|182954509|OTHER||Mean Difference (Final Values)|-2.82||||0.0483|TWO_SIDED||||||Paired samples t-test|||||||.0483
91538208|NCT05826431|182954510|OTHER||Mean Difference (Final Values)|-0.42||||0.123|TWO_SIDED||||||Paired samples t-test|||||||0.123
91538209|NCT01199237|182954511|SUPERIORITY_OR_OTHER|||||||0.11||||||Significant at p\<0.05|Chi-squared|||||||0.11
91538210|NCT03254394|182954526|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.318|TWO_SIDED|95.0|-7.09|20.85||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Average AUC of cold pain score over 14 days of a chemotherapy cycle in the Control group is equal or lower than that of the experimental group. The comparison is for average AUC values over 7 cycles of chemotherapy per patient||20.85|-7.09|0.318
91538211|NCT03254394|182954526|SUPERIORITY||Mean Difference (Final Values)|7.67||||0.466|TWO_SIDED|95.0|-13.76|29.1||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Cold hypersensitivity counted as unpleasantness score for 14 days after cycle (AUC) in the Control group is less than that of the experimental group. The difference was calculated for the Cycle 6 visit.||29.10|-13.76|0.466
91538212|NCT03254394|182954527|SUPERIORITY||Median Difference (Final Values)|20.0||||0.338|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||the null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.338
91538213|NCT03254394|182954527|SUPERIORITY||Median Difference (Final Values)|2.0||||0.759|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the cycle 6 (12 weeks) follow-up study visit.||||0.759
91538214|NCT03254394|182954528|SUPERIORITY||Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C3 (6 weeks) study visit.||||0.581
91538215|NCT03254394|182954528|SUPERIORITY||Median Difference (Final Values)|0.0||||0.962|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C6 (12 weeks) study visit.||||0.962
91538216|NCT03254394|182954528|SUPERIORITY||Median Difference (Final Values)|10.5||||0.365|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.365
91538217|NCT03254394|182954529|SUPERIORITY||Mean Difference (Final Values)|57.68||||0.73|TWO_SIDED|95.0|-1771.0|1886.0|||t-test, 2 sided|||The null hypothesis is Oxaliplatin cumulative dose in the Control group is equal to or higher than that of the experimental group.||1886|-1771|0.730
91538218|NCT01212757|182954530|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.4||||0.006|TWO_SIDED|95.0|4.0|22.7|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||22.7|4.0|0.0060
91538219|NCT01212757|182954530|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.7||||0.0002|TWO_SIDED|95.0|9.1|28.2|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.2|9.1|0.0002
91763397|NCT02287467|183417204|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.4|TWO_SIDED|95.0|0.48|6.15|||Regression, Cox|stratified by baseline clinical status, region, and participation in pilot study|hazard ratio is for hIVIG vs placebo; a hazard ratio \< 1.0 favors the hIVIG group.|||6.15|.48|.40
91763398|NCT02287467|183417205|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.38|1.98|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo; an odds ratio \> 1.0 favors hIVIG|||1.98|.38|.74
91763399|NCT02287467|183417206|SUPERIORITY||Mean Difference (Net)|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.54|||Regression, Linear|Adjusted for baseline RNA, geographic region, and influenza subtype|Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.|||.54|-.26|.49
91538220|NCT01212757|182954531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14||||0.0042|TWO_SIDED|95.0|-0.236|-0.045|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.045|-0.236|0.0042
91538221|NCT01212757|182954531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.104||||0.032|TWO_SIDED|95.0|-0.199|-0.009|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.009|-0.199|0.0320
91538222|NCT01212757|182954532|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.2||||0.0394|TWO_SIDED|95.0|0.5|17.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|0.5|0.0394
91538223|NCT01212757|182954532|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|15.7||||0.0009|TWO_SIDED|95.0|6.7|24.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.7|6.7|0.0009
91538224|NCT01212757|182954533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.121||||0.0191|TWO_SIDED|95.0|-0.222|-0.02|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.020|-0.222|0.0191
91538225|NCT01212757|182954533|SUPERIORITY||LS Mean Difference|-0.08||||0.1179|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.020|-0.180|0.1179
91538226|NCT01212757|182954534|SUPERIORITY||LS Mean Difference|2.1||||0.0237|TWO_SIDED|95.0|0.28|3.92|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.92|0.28|0.0237
91538227|NCT01212757|182954534|SUPERIORITY||LS Mean Difference|1.36||||0.1388|TWO_SIDED|95.0|-0.44|3.15|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.15|-0.44|0.1388
91538228|NCT01212757|182954535|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9||||0.0065|TWO_SIDED|95.0|4.3|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.5|4.3|0.0065
91538229|NCT01212757|182954535|SUPERIORITY||Adjusted Difference|14.7||||0.0071|TWO_SIDED|95.0|4.1|25.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.2|4.1|0.0071
91538230|NCT01212757|182954536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9||||0.0648|TWO_SIDED|95.0|-10.0|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-10.0|0.0648
91538231|NCT01212757|182954536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.5||||0.0347|TWO_SIDED|95.0|-10.6|-0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.4|-10.6|0.0347
91538232|NCT01212757|182954537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.3496|TWO_SIDED|95.0|-1.2|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.2|0.3496
91538233|NCT01212757|182954537|SUPERIORITY||LS Mean Difference|0.1||||0.8874|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.7|0.8874
91538234|NCT01212757|182954538|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.5438|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.5|-1.0|0.5438
91538235|NCT01212757|182954538|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.3759|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.0|-0.4|0.3759
91538236|NCT01212757|182954539|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51||||0.0035|TWO_SIDED|95.0|-5.86|-1.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-1.16|-5.86|0.0035
91538237|NCT01212757|182954539|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.45||||0.0002|TWO_SIDED|95.0|-6.76|-2.14|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.14|-6.76|0.0002
91538238|NCT01212757|182954540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.0004|TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.18|-0.61|0.0004
91538239|NCT01212757|182954540|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.25|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.25|-0.68|<0.0001
91538240|NCT01212757|182954541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12||||0.0318|TWO_SIDED|95.0|0.19|4.06|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.06|0.19|0.0318
91538241|NCT01212757|182954541|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27||||0.7803|TWO_SIDED|95.0|-1.65|2.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.20|-1.65|0.7803
91538242|NCT01212757|182954542|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86||||0.0473|TWO_SIDED|95.0|0.02|3.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.70|0.02|0.0473
91538243|NCT01212757|182954542|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.53||||0.0997|TWO_SIDED|95.0|-0.29|3.35|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.35|-0.29|0.0997
91538244|NCT01212757|182954543|SUPERIORITY||Adjusted Difference|7.8||||0.1195|TWO_SIDED|95.0|-1.9|17.5||The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.5|-1.9|0.1195
91538245|NCT01212757|182954543|SUPERIORITY||Adjusted Difference|15.5||||0.0026|TWO_SIDED|95.0|5.6|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.5|5.6|0.0026
91538246|NCT01212757|182954544|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.7||||0.5067|TWO_SIDED|95.0|-6.8|3.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.4|-6.8|0.5067
91538247|NCT01212757|182954544|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-3.5||||0.1762|TWO_SIDED|95.0|-8.5|1.6|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.6|-8.5|0.1762
91538248|NCT01212757|182954545|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.2719|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-1.2|0.2719
91538249|NCT01212757|182954545|SUPERIORITY||LS Mean Difference|0.0||||0.9727|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.7|-0.8|0.9727
91538250|NCT01212757|182954546|SUPERIORITY||LS Mean Difference|-0.3||||0.3705|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.0|0.3705
91538251|NCT01212757|182954546|SUPERIORITY||LS Mean Difference|0.1||||0.6777|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.6|0.6777
91538252|NCT01212757|182954547|SUPERIORITY||LS Mean Difference|-3.14||||0.0097|TWO_SIDED|95.0|-5.52|-0.76|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.76|-5.52|0.0097
91538253|NCT01212757|182954547|SUPERIORITY||LS Mean Difference|-4.5||||0.0002|TWO_SIDED|95.0|-6.85|-2.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.16|-6.85|0.0002
91538254|NCT01212757|182954548|SUPERIORITY||LS Mean Difference|-0.38||||0.0011|TWO_SIDED|95.0|-0.6|-0.15|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.15|-0.60|0.0011
91538255|NCT01212757|182954548|SUPERIORITY||LS Mean Difference|-0.45||||0.0001|TWO_SIDED|95.0|-0.68|-0.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.23|-0.68|0.0001
91538256|NCT01212757|182954549|SUPERIORITY||LS Mean Difference|2.14||||0.0303|TWO_SIDED|95.0|0.2|4.07|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.07|0.20|0.0303
91538257|NCT01212757|182954549|SUPERIORITY||LS mean Difference|0.16||||0.8704|TWO_SIDED|95.0|-1.76|2.08|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.08|-1.76|0.8704
91538258|NCT01212757|182954550|SUPERIORITY||Adjusted Difference|3.6||||0.6022|TWO_SIDED|95.0|-9.9|17.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||17.2|-9.9|0.6022
91538259|NCT01212757|182954550|SUPERIORITY||Adjusted Difference|1.3||||0.8462|TWO_SIDED|95.0|-12.1|14.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||14.7|-12.1|0.8462
91538260|NCT01212757|182954551|SUPERIORITY||Adjusted Difference|2.8||||0.7337|TWO_SIDED|95.0|-13.3|18.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-13.3|0.7337
91538261|NCT01212757|182954551|SUPERIORITY||Adjusted Difference|3.3||||0.6881|TWO_SIDED|95.0|-12.7|19.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-12.7|0.6881
91538262|NCT01212757|182954552|SUPERIORITY||Adjusted Difference|17.5||||0.0014|TWO_SIDED|95.0|7.0|27.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|7.0|0.0014
91538263|NCT01212757|182954552|SUPERIORITY||Adjusted Difference|22.1||||0.0001|TWO_SIDED|95.0|11.7|32.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||32.5|11.7|0.0001
91538264|NCT01212757|182954553|SUPERIORITY||Adjusted Difference|6.6||||0.3376|TWO_SIDED|95.0|-6.8|20.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.0|-6.8|0.3376
91538265|NCT01212757|182954553|SUPERIORITY||Adjusted Difference|6.1||||0.3756|TWO_SIDED|95.0|-7.2|19.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.4|-7.2|0.3756
91538266|NCT01212757|182954554|SUPERIORITY||Adjusted Difference|6.8||||0.3959|TWO_SIDED|95.0|-8.7|22.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.2|-8.7|0.3959
91538267|NCT01212757|182954554|SUPERIORITY||Adjusted Difference|6.8||||0.3941|TWO_SIDED|95.0|-8.7|22.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-8.7|0.3941
91538268|NCT01212757|182954555|SUPERIORITY||Adjusted Difference|12.1||||0.0142|TWO_SIDED|95.0|2.6|21.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.7|2.6|0.0142
91538269|NCT01212757|182954555|SUPERIORITY||Adjusted Difference|20.5||||0.0001|TWO_SIDED|95.0|10.8|30.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.3|10.8|0.0001
91538270|NCT01212757|182954556|SUPERIORITY||Adjusted Difference|5.6||||0.0589|TWO_SIDED|95.0|-0.2|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||11.3|-0.2|0.0589
91538271|NCT01212757|182954556|SUPERIORITY||Adjusted Difference|9.8||||0.0034|TWO_SIDED|95.0|3.4|16.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|3.4|0.0034
91538272|NCT01212757|182954557|SUPERIORITY||Adjusted Difference|0.6||||0.562|TWO_SIDED|95.0|-1.5|2.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||2.7|-1.5|0.5620
91763400|NCT02287467|183417207|SUPERIORITY||Odds Ratio (OR)|0.97||||0.93|TWO_SIDED|95.0|0.5|1.97|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study.|Odds ratio is for hIVIG vs placebo.|||1.97|0.5|.93
91538273|NCT01212757|182954557|SUPERIORITY||Adjusted Difference|3.1||||0.057|TWO_SIDED|95.0|0.0|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.2|-0.0|0.0570
91538274|NCT01212757|182954558|SUPERIORITY||Adjusted Difference|3.1||||0.3629|TWO_SIDED|95.0|-3.5|9.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.6|-3.5|0.3629
91538275|NCT01212757|182954558|SUPERIORITY||Adjusted Difference|5.4||||0.1323|TWO_SIDED|95.0|-1.5|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||12.3|-1.5|0.1323
91538276|NCT01212757|182954559|SUPERIORITY||Adjusted Difference|-0.6||||0.7273|TWO_SIDED|95.0|-4.3|3.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||3.0|-4.3|0.7273
91538277|NCT01212757|182954559|SUPERIORITY||Adjusted Difference|2.4||||0.2929|TWO_SIDED|95.0|-2.0|6.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.8|-2.0|0.2929
91538278|NCT01212757|182954560|SUPERIORITY||Adjusted Difference|-2.2||||0.7023|TWO_SIDED|95.0|-13.5|9.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.1|-13.5|0.7023
91538279|NCT01212757|182954560|SUPERIORITY||Adjusted Difference|5.9||||0.3305|TWO_SIDED|95.0|-5.9|17.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.7|-5.9|0.3305
91538280|NCT01212757|182954561|SUPERIORITY||Adjusted Difference|0.3||||0.9698|TWO_SIDED|95.0|-16.0|16.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.6|-16.0|0.9698
91538281|NCT01212757|182954561|SUPERIORITY||Adjusted Difference|1.9||||0.8205|TWO_SIDED|95.0|-14.3|18.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.1|-14.3|0.8205
91538282|NCT01212757|182954562|SUPERIORITY||Adjusted Difference|-1.2||||0.8424|TWO_SIDED|95.0|-12.7|10.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||10.3|-12.7|0.8424
91538283|NCT01212757|182954562|SUPERIORITY||Adjusted Difference|5.9||||0.3395|TWO_SIDED|95.0|-6.0|17.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|-6.0|0.3395
91538284|NCT01212757|182954563|SUPERIORITY||Adjusted Difference|5.9||||0.4811|TWO_SIDED|95.0|-10.3|22.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.1|-10.3|0.4811
91538285|NCT01212757|182954563|SUPERIORITY||Adjusted Difference|3.3||||0.6965|TWO_SIDED|95.0|-13.3|19.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.5|-13.3|0.6965
91763401|NCT02287467|183417208|SUPERIORITY||Odds Ratio (OR)|0.92||||0.81|TWO_SIDED|95.0|0.5|1.82|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG group vs placebo|||1.82|0.5|.81
91763402|NCT02287467|183417209|SUPERIORITY||Odds Ratio (OR)|1.17||||0.55|TWO_SIDED|95.0|0.7|1.95|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study|Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \> 1 favors the hIVIG group.|Proportional odds for being in a better category||1.95|0.70|.55
91763403|NCT02287467|183417210|SUPERIORITY||Odds Ratio (OR)|1.12||||0.77|TWO_SIDED|95.0|0.5|2.31|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo|||2.31|.5|.77
91763404|NCT02287467|183417211|SUPERIORITY||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.7|2.34|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is expressed as hIVIG vs placebo|||2.34|0.7|.34
91538286|NCT01049503|182954596|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni's test."||||<0.05
91538287|NCT01049503|182954597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
91538288|NCT01049503|182954598|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
91538289|NCT01049503|182954599|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey's test."||||<0.05
91538290|NCT01049503|182954600|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn's tests.||||<0.05
91538291|NCT01049503|182954601|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey's test.||||<0.05
91538292|NCT01049503|182954602|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
91538293|NCT02525796|182954605|SUPERIORITY||Median Difference (Net)|3.2||||0.84|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and placebo||||0.84
91538294|NCT02525796|182954605|SUPERIORITY||Median Difference (Net)|4.5||||0.54|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between amiloride monotherapy and placebo||||0.54
91538295|NCT02525796|182954605|SUPERIORITY||Median Difference (Net)|7.6||||0.58|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.58
91763405|NCT02287467|183417212|SUPERIORITY||Odds Ratio (OR)|0.9||||0.73|TWO_SIDED|95.0|0.5|1.62||adjusted for baseline clinical status, region, and participation in pilot study|Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \>1 favors the hIVIG group.|||1.62|.50|.73
91763406|NCT02287467|183417213|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.55|1.59|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio (hIVIG vs placebo) is for being in a better category.|Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.||1.59|0.55|.82
91538296|NCT02525796|182954606|SUPERIORITY||Median Difference (Net)|0.0||||0.82|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and placebo||||0.82
91538297|NCT02525796|182954606|SUPERIORITY||Median Difference (Net)|0.1||||0.21|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between amiloride monotherapy and placebo||||0.21
91538298|NCT02525796|182954606|SUPERIORITY||Median Difference (Net)|0.1||||0.12|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.12
91538299|NCT01198275|182954617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.05|TWO_SIDED|95.0|0.292|0.666|||Kaplan Meyer analysis|The time to first AF recurrence was analyzed with the Kaplan-Meier method and compared with the log-rank test.|Hazard ratios between n-3 PUFA and Placebo together with confidence intervals were estimated using the Cox proportional regression model.|Give a relapse rate ranging from 40% to 60% on ACE-I/ARB and amiodarone therapy, considering the high risk of relapses in our study population we conservatively assumed a 50% relapse rate. We calculated that a total of 180 patients would yield 80% power to detect a clinically relevant difference of about 20% in AF recurrence with the addition of n-3 PUFAs at a log-rank test, with a significance level of 0.05.||0.666|0.292|< 0.05
91538300|NCT02729701|182954635|OTHER|||||||0.017||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change by paired two-sample non-parametric test||||0.017
91538301|NCT02729701|182954636|OTHER|||||||0.043||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|2-sided||Test for within-group change via paired, two-sample non-parametric test||||0.043
91538302|NCT02729701|182954637|OTHER|||||||0.088||||||a priori threshold for statistical significance \< 0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change using paired two-sample non-parametric etst||||0.088
91538303|NCT02477670|182954639|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.79||||0.073|TWO_SIDED|95.0|-3.75|0.17|||Mixed Models Analysis|||Sequential Parallel Comparison Design (SPCD) Weighted Ordinary Least Squares (OLS) z-statistic. Treatment differences in each stage were estimated by the Mixed Model Repeated Measures (MMRM).||0.17|-3.75|0.073
91538304|NCT02477670|182954640|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.25||||0.025|TWO_SIDED|95.0|-4.21|-0.29|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.29|-4.21|0.025
91763407|NCT02287467|183417214|SUPERIORITY||Odds Ratio (OR)|3.19||||0.02|TWO_SIDED|95.0|1.21|8.42|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \> 1 favors the hIVIG group.|Multiple imputation was used to estimate the outcome for one participant.||8.42|1.21|.02
91538305|NCT02477670|182954641|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.2||||0.027|TWO_SIDED|95.0|-4.16|-0.24|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.24|-4.16|0.027
91538306|NCT02477670|182954642|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.26||||0.024|TWO_SIDED|95.0|-4.22|-0.3|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.3|-4.22|0.024
91538307|NCT02477670|182954643|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.6||||0.009|TWO_SIDED|95.0|-4.56|-0.64|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.64|-4.56|0.009
91538308|NCT02477670|182954644|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.39||||0.7|TWO_SIDED|95.0|-2.35|1.57|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.57|-2.35|0.700
91538309|NCT02477670|182954645|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.93||||0.054|TWO_SIDED|95.0|-3.89|0.03|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.03|-3.89|0.054
91538310|NCT02477670|182954646|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.35||||0.723|TWO_SIDED|95.0|-2.31|1.61|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.61|-2.31|0.723
91538311|NCT02477670|182954647|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.85||||0.064|TWO_SIDED|95.0|-3.81|0.11|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.11|-3.81|0.064
91538312|NCT02477670|182954648|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.64||||0.1|TWO_SIDED|95.0|-3.6|0.32|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.32|-3.6|0.100
91538313|NCT02477670|182954649|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.86||||0.388|TWO_SIDED|95.0|-2.82|1.1|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.1|-2.82|0.388
91538314|NCT02477670|182954650|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.9||||0.367|TWO_SIDED|95.0|-2.86|1.06|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.06|-2.86|0.367
91538315|NCT02477670|182954651|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.76||||0.447|TWO_SIDED|95.0|-2.72|1.2|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.2|-2.72|0.447
91538316|NCT02477670|182954652|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.23||||0.026|TWO_SIDED|95.0|-4.19|-0.27|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.27|-4.19|0.026
91538317|NCT02477670|182954653|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.62||||0.106|TWO_SIDED|95.0|-3.58|0.34|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.34|-3.58|0.106
91538318|NCT02477670|182954654|SUPERIORITY||SPCD Weighted OLS z-statistic|1.78||||0.074|TWO_SIDED|95.0|-0.18|3.74|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||3.74|-0.18|0.074
91538319|NCT02477670|182954655|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.79||||0.427|TWO_SIDED|95.0|-2.75|1.17|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.17|-2.75|0.427
91538320|NCT02477670|182954656|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.91||||0.0566|TWO_SIDED|95.0|-3.87|0.05|||McNemar|||Treatment differences in each stage were estimated by the MMRM.||0.05|-3.87|0.0566
91538321|NCT02477670|182954657|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.37||||0.17|TWO_SIDED|95.0|-3.33|0.59|||ANCOVA|||||0.59|-3.33|0.1700
91538322|NCT02477670|182954658|SUPERIORITY||SPCD Weighted OLS z-statistic|0.53||||0.595|TWO_SIDED|95.0|-1.43|2.49|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.49|-1.43|0.595
91538323|NCT02477670|182954659|SUPERIORITY||SPCD Weighted OLS z-statistic|2.284||||0.022|TWO_SIDED|95.0|0.324|4.244|||ANCOVA|||||4.244|0.324|0.022
91538324|NCT02477670|182954660|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.17||||0.862|TWO_SIDED|95.0|-2.13|1.79|||ANCOVA|||||1.79|-2.13|0.862
91538325|NCT02477670|182954661|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.149||||0.251|TWO_SIDED|95.0|-3.109|0.811|||ANCOVA|||||0.811|-3.109|0.251
91538326|NCT02477670|182954662|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.159||||0.246|TWO_SIDED|95.0|-3.119|0.801|||ANCOVA|||||0.801|-3.119|0.246
91538327|NCT02477670|182954663|SUPERIORITY||SPCD Weighted OLS z-statistic|0.231||||0.818|TWO_SIDED|95.0|-1.729|2.191|||ANCOVA|||||2.191|-1.729|0.818
91538328|NCT02477670|182954664|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.04||||0.968|TWO_SIDED|95.0|-2.0|1.92|||ANCOVA|||||1.92|-2.00|0.968
91538329|NCT02477670|182954665|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.306||||0.76|TWO_SIDED|95.0|-2.266|1.654|||ANCOVA|||||1.654|-2.266|0.760
91538330|NCT02477670|182954666|SUPERIORITY||SPCD Weighted OLS z-statistic|1.243||||0.214|TWO_SIDED|95.0|-0.717|3.203|||ANCOVA|||||3.203|-0.717|0.214
91538331|NCT02477670|182954667|SUPERIORITY|||||||0.071|||||||SPCD 1 degree of freedom score test|||||||0.071
91538332|NCT02477670|182954668|SUPERIORITY||SPCD Weighted OLS z-statistic|0.951||||-0.06|TWO_SIDED|95.0|-1.009|2.911|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.911|-1.009|-0.06
91538333|NCT00970307|182954669|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.76|||||TWO_SIDED|95.0|-4.21|2.22||||||||2.22|-4.21|
91538334|NCT00970307|182954670|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardized asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.72|||||TWO_SIDED|95.0|-5.19|3.57||||||||3.57|-5.19|
91538335|NCT01930045|182954774|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.4||||0.507|TWO_SIDED|90.0|0.31|0.52|||Hochberg step-up procedure||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs geometric mean ratio (GMR) is not less than 0.4||0.52|0.31|0.507
91538336|NCT01930045|182954774|SUPERIORITY_OR_OTHER||GMR|0.38||||0.624|TWO_SIDED|90.0|0.3|0.49|||Hochberg step-up procedure||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.49|0.30|0.624
91538337|NCT01930045|182954775|SUPERIORITY_OR_OTHER||GMR|0.81|||||TWO_SIDED|90.0|0.63|1.05|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.05|0.63|
91538338|NCT01930045|182954775|SUPERIORITY_OR_OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.5|0.92|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||0.92|0.50|
91538339|NCT01930045|182954776|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.55|1.1|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.10|0.55|
91538340|NCT01930045|182954776|SUPERIORITY_OR_OTHER||GMR|0.7|||||TWO_SIDED|90.0|0.48|1.04|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.04|0.48|
91538341|NCT01930045|182954777|SUPERIORITY_OR_OTHER||GMR|0.5|||||TWO_SIDED|90.0|0.39|0.65|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.65|0.39|
91538342|NCT01930045|182954777|SUPERIORITY_OR_OTHER||GMR|0.51|||||TWO_SIDED|90.0|0.4|0.64|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.64|0.40|
91538343|NCT01930045|182954778|SUPERIORITY_OR_OTHER||GMR|0.87|||||TWO_SIDED|90.0|0.64|1.18|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.18|0.64|
91538344|NCT01930045|182954778|SUPERIORITY_OR_OTHER||GMR|0.89|||||TWO_SIDED|90.0|0.64|1.22|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.22|0.64|
91538345|NCT01930045|182954779|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.4|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.40|0.58|
91538346|NCT01930045|182954779|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.41|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.41|0.58|
91538347|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.49|||<|0.001|TWO_SIDED|95.0|1.55|3.99|||Log Rank|||All participants: p-value was calculated using log-rank test.||3.99|1.55|<0.001
91538348|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.38||||0.002|TWO_SIDED|95.0|1.57|7.28|||Regression, Cox|||Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.||7.28|1.57|0.002
91538349|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.03||||0.021|TWO_SIDED|95.0|1.11|3.68|||Regression, Cox|||Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||3.68|1.11|0.021
91538350|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.82|||<|0.001|TWO_SIDED|95.0|1.7|4.67|||Regression, Cox|||Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||4.67|1.70|<0.001
91538351|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||<|0.001|TWO_SIDED|95.0|1.7|5.04|||Regression, Cox|||Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.04|1.70|<0.001
91538352|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.62||||0.012|TWO_SIDED|95.0|1.32|9.89|||Regression, Cox|||Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||9.89|1.32|0.012
91538353|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.12||||0.006|TWO_SIDED|95.0|1.39|6.98|||Regression, Cox|||Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||6.98|1.39|0.006
91538354|NCT01193153|182954832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.93||||0.238|TWO_SIDED|95.0|0.65|5.78|||Regression, Cox|||Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.78|0.65|0.238
91538355|NCT01193153|182954833|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.68|5.95||P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.|MMRM ANCOVA|||The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.||5.95|0.68|0.014
91538356|NCT01193153|182954835|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|1.94|7.15||Change at Endpoint (Week 64/LOCF)|ANCOVA|||||7.15|1.94|<0.001
91538357|NCT01678196|182954849|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||Chi-squared|||||||0.927
91538358|NCT01678196|182954850|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.||||||0.67
91538359|NCT01678196|182954851|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time||||||0.743
91538360|NCT01678196|182954852|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)||||||<.001
91538361|NCT03951649|182954892|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
91538362|NCT03951649|182954893|SUPERIORITY||||||>|0.99||||||The p-value was calculated using a 2 sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||>0.99
91538363|NCT03951649|182954894|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
91538364|NCT03951649|182954895|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91538365|NCT03951649|182954896|SUPERIORITY|||||||1||||||P-value was calculated|Fisher Exact|||||||1.00
91538366|NCT03951649|182954897|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
91538367|NCT03951649|182954898|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
91538368|NCT03951649|182954900|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
91538369|NCT03951649|182954901|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
91538370|NCT03951649|182954902|SUPERIORITY|||||||0.92|||||||Fisher Exact|||||||0.92
91538371|NCT03951649|182954903|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91538372|NCT03951649|182954904|SUPERIORITY|||||||0.14|||||||Fisher Exact|||||||0.14
91538373|NCT03951649|182954905|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
91538374|NCT00758602|182954917|SUPERIORITY_OR_OTHER||LS Mean difference|0.6581||||0.0813|TWO_SIDED|95.0|-0.08|1.4||p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||1.40|-0.08|0.0813
91538375|NCT00758602|182954918|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5977||||0.7949|TWO_SIDED|95.0|-13.77|10.58||p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||10.58|-13.77|0.7949
91538376|NCT00758602|182954919|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 6 months post-transplant||||0.6812
91538377|NCT00758602|182954919|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 12 months post-transplant||||0.6812
91538378|NCT00758602|182954919|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Death, 12 months post-transplant||||1.0000
91538379|NCT00758602|182954921|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0000
91538380|NCT00758602|182954922|SUPERIORITY_OR_OTHER|||||||0.4586|||||||Fisher Exact|||||||0.4586
91538381|NCT00758602|182954923|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91538382|NCT00208507|182954931|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This was a non-inferiority test of the Harris Hip Score means at 24+ months with a 5 point non-inferiority margin.|Mean Difference (Final Values)|0.61||||0.001|ONE_SIDED|95.0|-1.56||||ANCOVA|Preoperative Harris Hip score was included in the ANCOVA model as the only covariate.|||||-1.56|0.001
91538383|NCT00982033|182954951|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|||||||0.90
91538384|NCT00855465|182955007|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis, due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew/died before 16 weeks were imputed with a worst value of 0m in case of death/clinical worsening without termination visit and with the last observed value otherwise. Comparison was done using analysis of covariance (ANCOVA), with baseline 6MWD as a covariate and treatment group and region as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant.||||<0.0001
91538385|NCT00855465|182955007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|45.69|||<|0.0001|TWO_SIDED|95.0|24.74|66.63||Additional analysis, due to result of Shapiro-Wilk test.|ANCOVA|||||66.63|24.74|<0.0001
91538386|NCT00855465|182955007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91538387|NCT00855465|182955008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
91538388|NCT00855465|182955008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-246.43|||<|0.0001|TWO_SIDED|95.0|-303.33|-189.53||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-189.53|-303.33|<0.0001
91538389|NCT00855465|182955008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91538390|NCT00855465|182955009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
91538391|NCT00855465|182955009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-443.99||||0.0293|TWO_SIDED|95.0|-842.95|-45.03||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-45.03|-842.95|0.0293
91538392|NCT00855465|182955009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91538393|NCT00855465|182955010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0026
91538394|NCT00855465|182955011|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.37||||0.1724|TWO_SIDED|95.0|-8.72|1.99||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region.|Based on Mantel-Haenszel estimate stratified by region.|"Test for difference of occurence of Any event."||1.99|-8.72|0.1724
91538395|NCT00855465|182955012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0035
91538396|NCT00855465|182955013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||<0.0001
91538397|NCT00855465|182955013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.0002|TWO_SIDED|95.0|0.06|0.21||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.21|0.06|0.0002
91538398|NCT00855465|182955013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91538399|NCT00855465|182955014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg Dyspnea Score, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.1220
91538400|NCT00855465|182955014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.76||||0.0165|TWO_SIDED|95.0|-10.45|-1.06||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-1.06|-10.45|0.0165
91538401|NCT00855465|182955014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
91538402|NCT00855465|182955016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||||<0.0001
91538403|NCT00855465|182955016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.96|||<|0.0001|TWO_SIDED|95.0|-6.75|-3.16||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-3.16|-6.75|<0.0001
91538404|NCT00855465|182955016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0231|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0231
91538405|NCT00855465|182955017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.62||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|ANCOVA|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||0.62|0.33|<0.0001
91538406|NCT00855465|182955017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Additional analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||||||<0.0001
91538407|NCT00855465|182955017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.1160
91538408|NCT04365400|182955055|SUPERIORITY||Hodges Lehmann Median|8.24||||0.1148124|TWO_SIDED|95.0|-2.01|18.19|||Wilcoxon (Mann-Whitney)|||||18.19|-2.01|0.1148124
91538409|NCT04365400|182955055|SUPERIORITY||Hodges Lehmann Median|-0.82||||0.8668467|TWO_SIDED|95.0|-10.16|7.96|||Wilcoxon (Mann-Whitney)|||||7.96|-10.16|0.8668467
91538410|NCT04365400|182955056|SUPERIORITY||Difference in Change in HbA1c (%)|0.02516||||0.8658|TWO_SIDED|95.0|-0.26658|0.316897|||ANCOVA|||||0.316897|-0.26658|0.8658
91538411|NCT04365400|182955056|SUPERIORITY||Difference in Change in HbA1c (%)|-0.07333||||0.65|TWO_SIDED|95.0|-0.39012|0.243455|||ANCOVA|||||0.243455|-0.39012|0.6500
91538412|NCT00612586|182955059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956||||||One sided|Log Rank|||||||0.8956
91538413|NCT00612586|182955060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9865||||||One-sided|Log Rank|||||||0.9865
91538414|NCT02613364|182955064|NON_INFERIORITY|Non-inferiority is established if the difference in mean change on the ISI between YOCAS©® and CBT-I is less than 1.15. Using ANCOVA to estimate differences in mean change between YOCAS©® and CBT-I, a correlation of 0.576 (from our prior study), and a sample of 168 subjects per group, we will have sufficient (80%) power to detect non-inferiority using a margin of 1.15 at p = 0.025.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|2.66|4.37||The p-value shown above is from the Least Squares Mean between YOCAS - CBT-I from the Mixed Model.|Mixed Models Analysis||The comparison is YOCAS - CBT-I|Constructed a 95% confidence interval on the mean change of ISI from baseline between the arms (YOCAS - CBT-I). If the lower bound of the interval is less than 1.5 then we conclude that YOCAS is non-inferior.||4.37|2.66|<.0001
91538415|NCT02613364|182955065|SUPERIORITY|Using ANCOVA to estimate differences in mean change between YOCAS and health education, a correlation of 0.576 (from our prior study), and a sample size of 168 evaluable subjects per group, we will have sufficient power to detect differences on the ISI of at least 1.3, 1.5 and 1.6 (all larger than our 1.15 non-inferiority margin) at 80%, 90%, and 95% power, respectively|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0009|TWO_SIDED|95.0|-2.23|-0.58||the comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.58|-2.23|0.0009
91538416|NCT02613364|182955066|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-0.98|0.04||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.04|-0.98|0.0700
91763408|NCT02287467|183417215|SUPERIORITY||ratio of geometric means|1.5||||0.18|TWO_SIDED|95.0|0.84|2.7|||Mixed Models Analysis|longitudinal regression with adjustment for baseline titer|Ratio of hIVIG group to placebo group. A ratio \> 1.0 indicates higher titers for the hIVIG group.|HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.||2.7|0.84|.18
91538417|NCT02613364|182955067|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.7|2.75||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||2.75|1.70|<.0001
91538418|NCT02613364|182955068|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|19.73|STANDARD_ERROR_OF_MEAN|7.03||0.0052|TWO_SIDED|95.0|5.91|33.54||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||33.54|5.91|0.0052
91538419|NCT02613364|182955069|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|15.94|STANDARD_ERROR_OF_MEAN|7.12||0.0258|TWO_SIDED|95.0|1.93|29.94||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis|||||29.94|1.93|0.0258
91538420|NCT02613364|182955070|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.92|TWO_SIDED|95.0|-0.053|0.048||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|||0.048|-0.053|0.92
91538421|NCT02613364|182955071|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.07|TWO_SIDED|95.0|-0.004|0.098||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to the CBT-I control is a traditional null hypothesis of no difference with a two-sided alpha.||0.098|-0.004|0.07
91538422|NCT02613364|182955072|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.11||0.04|TWO_SIDED|95.0|0.09|4.44||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||4.44|0.09|0.04
91538423|NCT02613364|182955073|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.12||0.49|TWO_SIDED|95.0|-2.97|1.43||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||1.43|-2.97|0.49
91538424|NCT02613364|182955074|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.43|TWO_SIDED|95.0|-0.13|0.05||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.05|-0.13|0.43
91538425|NCT02613364|182955075|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7|TWO_SIDED|95.0|-0.07|0.11||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||0.11|-0.07|0.70
91763409|NCT02287467|183417216|SUPERIORITY||ratio of geometric means|1.31||||0.13|TWO_SIDED|95.0|0.93|1.8|||Mixed Models Analysis|longitudinal analysis of log-transformed titers adjust for baseline titer.|Ratio of geometric means of hIVIG vs placebo. A ratio \>1.0 indicates higher titers in the hIVIG group on day 7.|||1.8|0.93|.13
91763410|NCT02287467|183417217|SUPERIORITY||ratio of geometric means|0.94||||0.78|TWO_SIDED|95.0|0.58|1.5|||Mixed Models Analysis|log-transformed titers adjusted for baseline titer|ratio of geometric mean for hIVIG vs placebo. A ratio \> 1.0 indicates higher titers at day 7 for the hIVIG group.|||1.5|0.58|.78
91538426|NCT02613364|182955076|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.55||0.0041|TWO_SIDED|95.0|-2.65|-0.5||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.50|-2.65|0.0041
91538427|NCT02613364|182955077|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|1.61|3.81||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||3.81|1.61|<.0001
91538428|NCT02613364|182955078|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.62||0.0108|TWO_SIDED|95.0|-2.78|-0.36||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.36|-2.78|0.0108
91538429|NCT02613364|182955079|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|1.54|4.02||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||4.02|1.54|<.0001
91538430|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|3.17||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||3.17|-4.52|
91538431|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.06|||||TWO_SIDED|98.25|-3.94|4.38||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococcal serotype 4.||4.38|-3.94|
91538432|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|3.19||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||3.19|-4.63|
91538433|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.69|||||TWO_SIDED|98.25|-9.4|10.99||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||10.99|-9.4|
91538434|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.65|||||TWO_SIDED|98.25|-2.7|4.71||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||4.71|-2.7|
91763411|NCT01456169|183417234|SUPERIORITY_OR_OTHER||LS mean difference|-14.7|||<|0.001|TWO_SIDED|95.0|-17.6|-11.8|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate.||The type I error was controlled using a 2-step hierarchical testing procedure. In the first step, the high dose (40/25 mg) of Azilsartan medoxomil + chlorthalidone was compared to Azilsartan medoxomil alone. If the comparison in step 1 was statistically significant at a significance level of 5%, then step 2 was performed by comparing the low dose (40/12.5 mg) and monotherapy at the 5% significance level.||-11.8|-17.6|<0.001
91538435|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.05|3.82||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||3.82|-5.05|
91538436|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.65|||||TWO_SIDED|98.25|-4.68|3.15||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||3.15|-4.68|
91538437|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.04|3.85||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.85|-5.04|
91538438|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.6|3.14||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||3.14|-4.6|
91538439|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.08||||||98.25|-7.66|8.1||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||8.1|-7.66|
91538440|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||2.91|-4.52|
91538441|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.57|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 4.||2.91|-4.57|
91538442|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|2.92||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||2.92|-4.63|
91538443|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-2.38|||||TWO_SIDED|98.25|-12.02|7.22||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||7.22|-12.02|
91538444|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-3.34|3.48||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||3.48|-3.34|
91538445|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-1.27|||||TWO_SIDED|98.25|-5.66|2.32||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||2.32|-5.66|
91538446|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-4.08|4.12||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||4.12|-4.08|
91538447|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-5.08|3.54||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.54|-5.08|
91538448|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.67|||||TWO_SIDED|98.25|-3.4|5.2||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||5.2|-3.4|
91538449|NCT01235949|182955083|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|2.73|||||TWO_SIDED|98.25|-5.3|11.04||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||11.04|-5.3|
91538450|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.71|1.29||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.29|0.71|
91538451|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.77|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.35|0.77|
91538452|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.06|||||TWO_SIDED|99.8|0.8|1.41||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.41|0.8|
91538453|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.12|||||TWO_SIDED|99.8|0.72|1.74||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.74|0.72|
91538454|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.04|||||TWO_SIDED|99.8|0.79|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.35|0.79|
91538455|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.7|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.31|0.7|
91538456|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.71|1.4||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.4|0.71|
91538457|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.89|||||TWO_SIDED|99.8|0.6|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.31|0.6|
91538458|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.23|||||TWO_SIDED|99.8|0.87|1.75||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.75|0.87|
91538459|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.97|||||TWO_SIDED|99.8|0.66|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.44|0.66|
91538460|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.9|||||TWO_SIDED|99.8|0.67|1.21||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.21|0.67|
91538461|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.76|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.32|0.76|
91538462|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.66|1.14||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.14|0.66|
91538463|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.28|||||TWO_SIDED|99.8|0.83|1.97||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.97|0.83|
91538464|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.8|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.31|0.8|
91538465|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.92|||||TWO_SIDED|99.8|0.69|1.22||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.22|0.69|
91538466|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.95|||||TWO_SIDED|99.8|0.68|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.32|0.68|
91538467|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.88|||||TWO_SIDED|99.8|0.6|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.27|0.6|
91538468|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.72|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.44|0.72|
91538469|NCT01235949|182955084|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.58|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.27|0.58|
91538470|NCT01235949|182955085|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.94|||||TWO_SIDED|99.8|0.69|1.28||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.28|0.69|
91538471|NCT01235949|182955085|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.87|||||TWO_SIDED|99.8|0.64|1.17||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.17|0.64|
91538472|NCT04173572|182955134|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-13.47|STANDARD_DEVIATION|48.09|||TWO_SIDED|||||||||Posttreatment - Baseline: 10 participants analyzed (had data at both time points)||||
91538473|NCT04173572|182955134|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.7|STANDARD_DEVIATION|52.743|||TWO_SIDED|||||||||Posttreatment - Baseline: 9 participants analyzed (had data at both time points)||||
91538474|NCT04173572|182955135|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|22.133|STANDARD_DEVIATION|79.938|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538475|NCT04173572|182955135|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|99.645|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538476|NCT04173572|182955136|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|13.642|STANDARD_DEVIATION|4213.837|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
91538477|NCT04173572|182955136|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-483.4|STANDARD_DEVIATION|2497.312|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538478|NCT04173572|182955137|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.229|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538479|NCT04173572|182955137|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.563|STANDARD_DEVIATION|8.695|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
91538480|NCT04173572|182955138|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|-9.333|STANDARD_DEVIATION|14.166|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538481|NCT04173572|182955138|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|0.625|STANDARD_DEVIATION|9.664|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
91538482|NCT04173572|182955139|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.392|STANDARD_DEVIATION|1.148|||TWO_SIDED|||||||||Posttreatment - Baseline: 13 participants analyzed (had data at both time points)||||
91538483|NCT04173572|182955139|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.113|STANDARD_DEVIATION|1.401|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538484|NCT04173572|182955140|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.2|STANDARD_DEVIATION|20.11|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538485|NCT04173572|182955140|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.49|STANDARD_DEVIATION|8.91|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538486|NCT04173572|182955141|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.39|STANDARD_DEVIATION|4.67|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
91538487|NCT04173572|182955141|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.43|STANDARD_DEVIATION|9.4|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
91538488|NCT04173572|182955142|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-3.667|STANDARD_DEVIATION|9.067|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
91538489|NCT04173572|182955142|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.071|STANDARD_DEVIATION|12.25|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
91538490|NCT04173572|182955143|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|9.9|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
91538491|NCT04173572|182955143|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.714|STANDARD_DEVIATION|11.717|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
91538492|NCT04173572|182955144|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.071|STANDARD_DEVIATION|10.737|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
91538493|NCT04173572|182955144|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|5.571|STANDARD_DEVIATION|9.288|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
91538494|NCT02534350|182955167|SUPERIORITY||Treatment Difference|0.1||||0.72|TWO_SIDED|95.0|-0.43|0.63|||ANCOVA|||||0.63|-0.43|0.72
91538495|NCT02534350|182955168|SUPERIORITY||Treatment Difference|-0.12||||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
91538496|NCT02534350|182955169|SUPERIORITY||Treatment Difference|0.01||||0.86|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.86
91538497|NCT02534350|182955170|SUPERIORITY||Treatment Difference|-3.25||||0.6|TWO_SIDED|95.0|-15.58|9.08|||ANCOVA|||||9.08|-15.58|0.60
91538498|NCT00761930|182955215|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91538499|NCT00761930|182955216|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91538500|NCT00761930|182955217|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
91538501|NCT03478696|182955218|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.0154|||TWO_SIDED|95.0|-0.02|0.041|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.041|-0.020|
91763412|NCT01456169|183417234|SUPERIORITY_OR_OTHER||LS mean difference|-9.5|||<|0.001|TWO_SIDED|95.0|-12.4|-6.5|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate||||-6.5|-12.4|<0.001
91763413|NCT00479336|183417276|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.3167|TWO_SIDED|95.0|-0.061|0.02|||Regression, Linear|||A linear regression model using change in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset. The null hypothesis of whether the regression coefficient is zero (analysis using t-statistics) was tested at a two-tailed significance level of 0.05, and estimated values for the slope and 95% confidence interval were calculated.||0.020|-0.061|0.3167
91763414|NCT02631551|183417284|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.||||<0.0001
91763415|NCT02631551|183417284|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.||||0.0029
91763416|NCT02631551|183417284|SUPERIORITY|||||||0.0587|||||||Mixed Models Analysis|||GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.||||0.0587
91538502|NCT03478696|182955219|SUPERIORITY||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0122||0.037|TWO_SIDED|95.0|0.002|0.049||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.049|0.002|0.037
91538503|NCT03478696|182955219|SUPERIORITY||Mean Difference (Net)|0.063|STANDARD_ERROR_OF_MEAN|0.0134|<|0.001|TWO_SIDED|95.0|0.036|0.089||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.089|0.036|<0.001
91538504|NCT03478696|182955219|SUPERIORITY||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.026|0.083||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.083|0.026|<0.001
91538505|NCT03478696|182955219|SUPERIORITY||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.0157||0.001|TWO_SIDED|95.0|0.021|0.082||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.082|0.021|0.001
91538506|NCT03478696|182955220|SUPERIORITY||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.0098||0.702|TWO_SIDED|95.0|-0.016|0.023||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.023|-0.016|0.702
91538507|NCT03478696|182955221|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.0141||0.244|TWO_SIDED|95.0|-0.011|0.044||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.044|-0.011|0.244
91538508|NCT04673851|182955222|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.86|STANDARD_DEVIATION|5.44|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538509|NCT04673851|182955222|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.16|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538510|NCT04673851|182955222|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.65|STANDARD_DEVIATION|5.61|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538511|NCT04673851|182955222|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.47|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538512|NCT04673851|182955222|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.97|STANDARD_DEVIATION|7.19|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538513|NCT04673851|182955222|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538514|NCT04673851|182955222|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-4.15|STANDARD_DEVIATION|7.93|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538515|NCT04673851|182955222|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.52|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538516|NCT04673851|182955223|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.52|STANDARD_DEVIATION|8.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538517|NCT04673851|182955223|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538518|NCT04673851|182955223|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.15|STANDARD_DEVIATION|5.8|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538519|NCT04673851|182955223|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.2|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538520|NCT04673851|182955223|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.67|STANDARD_DEVIATION|10.29|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538521|NCT04673851|182955223|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.07|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538522|NCT04673851|182955223|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.07|STANDARD_DEVIATION|9.47|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538523|NCT04673851|182955223|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.22|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538524|NCT04673851|182955224|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.05|STANDARD_DEVIATION|7.08|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538525|NCT04673851|182955224|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.01|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538526|NCT04673851|182955224|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.35|STANDARD_DEVIATION|7.53|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538527|NCT04673851|182955224|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.31|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538528|NCT04673851|182955224|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|9.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538529|NCT04673851|182955224|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538530|NCT04673851|182955224|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.56|STANDARD_DEVIATION|9.6|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538531|NCT04673851|182955224|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538532|NCT04673851|182955225|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|8.27|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538533|NCT04673851|182955225|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.04|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
91538534|NCT04673851|182955225|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.6|STANDARD_DEVIATION|7.86|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91763417|NCT02631551|183417284|SUPERIORITY|||||||0.0755|||||||Mixed Models Analysis|||Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0755
91538535|NCT04673851|182955225|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
91538536|NCT04673851|182955225|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|2.17|STANDARD_DEVIATION|7.84|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538537|NCT04673851|182955225|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.28|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
91538538|NCT04673851|182955225|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|6.48|STANDARD_DEVIATION|8.5|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538539|NCT04673851|182955225|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.76|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
91538540|NCT04673851|182955226|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|4.11|STANDARD_DEVIATION|6.86|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
91538541|NCT04673851|182955226|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.6|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
91538542|NCT04673851|182955226|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.77|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
91538543|NCT04673851|182955226|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.11|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
91538544|NCT04673851|182955226|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538545|NCT04673851|182955226|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.03|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538546|NCT04673851|182955226|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.63|STANDARD_DEVIATION|7.95|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538547|NCT04673851|182955226|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538548|NCT04673851|182955227|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|1.68|STANDARD_DEVIATION|3.76|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
91538549|NCT04673851|182955227|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.45|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
91763418|NCT02631551|183417284|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0043
91763419|NCT01284517|183417285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.08||0.176|||||||Mixed Models Analysis|||Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.||||0.176
91763420|NCT01284517|183417286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.095|||||||Mixed Models Analysis|||||||0.095
91538550|NCT04673851|182955227|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|2.73|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
91538551|NCT04673851|182955227|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.02|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
91538552|NCT04673851|182955227|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.56|STANDARD_DEVIATION|2.44|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538553|NCT04673851|182955227|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.23|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91763421|NCT01284517|183417287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.992|||||||ANCOVA|||||||0.992
91763422|NCT03393494|183417288|EQUIVALENCE|provides 85% power of success|Equivalence ratio|107.0|||||TWO_SIDED|90.0|97.8|112.2|||Fieller's method|||||112.2|97.8|
91763423|NCT03393494|183417289|EQUIVALENCE|provides 85% power of success|Equivalence ratio|104.0||||0.05|TWO_SIDED|90.0|94.1|108.5|||Fieller's method|||||108.5|94.1|0.05
91538554|NCT04673851|182955227|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-0.59|STANDARD_DEVIATION|3.15|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538555|NCT04673851|182955227|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.19|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538556|NCT04673851|182955228|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|2.42|STANDARD_DEVIATION|4.48|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
91538557|NCT04673851|182955228|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.54|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
91538558|NCT04673851|182955228|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.83|STANDARD_DEVIATION|5.05|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
91538559|NCT04673851|182955228|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
91538560|NCT04673851|182955228|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|0.41|STANDARD_DEVIATION|4.55|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538561|NCT04673851|182955228|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538562|NCT04673851|182955228|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.04|STANDARD_DEVIATION|6.12|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538563|NCT04673851|182955228|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
91538564|NCT00716144|182955250|SUPERIORITY_OR_OTHER|||||||0.884|||||||Cochran-Armitage Trend Test|||||||0.884
91538565|NCT00716144|182955251|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
91538566|NCT00716144|182955251|SUPERIORITY_OR_OTHER|||||||0.604|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.604
91538567|NCT00716144|182955251|SUPERIORITY_OR_OTHER|||||||0.463|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.463
91538568|NCT00716144|182955251|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Armitage Trend Test|||At Visit 6||||0.042
91538569|NCT00716144|182955251|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.034
91538570|NCT00716144|182955251|SUPERIORITY_OR_OTHER|||||||0.019|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.019
91538571|NCT00716144|182955253|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
91538572|NCT00716144|182955253|SUPERIORITY_OR_OTHER|||||||0.673|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.673
91538573|NCT00716144|182955253|SUPERIORITY_OR_OTHER|||||||0.55|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.550
91538574|NCT00716144|182955253|SUPERIORITY_OR_OTHER|||||||0.721|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.721
91538575|NCT00716144|182955253|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.030
91538576|NCT00281918|182955296|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
91538577|NCT00281918|182955297|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
91538578|NCT00281918|182955298|SUPERIORITY_OR_OTHER|||||||0.0427||95.0|||||Log Rank|||||||0.0427
91538579|NCT00281918|182955299|SUPERIORITY_OR_OTHER|||||||0.7882||95.0|||||Log Rank|||||||0.7882
91538580|NCT00281918|182955300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
91538581|NCT00281918|182955301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.54|0.86|||Log Rank|||||0.86|0.54|0.0010
91538582|NCT00281918|182955302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
91538583|NCT00281918|182955303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0523|TWO_SIDED|95.0|0.52|1.02|||Log Rank|||||1.02|0.52|0.0523
91538584|NCT00281918|182955304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.71|||Log Rank|||||0.71|0.48|<.0001
91538585|NCT00281918|182955305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Chi-squared|||||3.28|1.62|<.0001
91538586|NCT00281918|182955306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.72|||Log Rank|||||0.72|0.49|<.0001
91538587|NCT03772964|182955308|SUPERIORITY|Comparisons between samples and sample groups (beta-diversity), were evaluated with ADONIS (aka PERMANOVA) comparisons of differences between sample groups.|R2|0.071435|||<|0.01|TWO_SIDED||||||ADONISBeta Diversity|Comparisons between samples and sample groups (beta-diversity) were evaluated with ADONIS (aka PERMANOVA)|R2 values estimate the amount of variation explained by each variable.|Beta Diversity - Differences between Samples and Sample groups||||<0.01
91538588|NCT03772964|182955309|SUPERIORITY|||||||0.6057|||||||ANOVA|||||||0.6057
91538589|NCT03772964|182955311|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91538590|NCT03772964|182955312|SUPERIORITY|||||||0.69|||||||ANOVA|||||||0.69
91538591|NCT01867580|182955351|SUPERIORITY|||||||0.677|||||||Regression, Logistic|||||||0.6770
91538592|NCT01867580|182955352|SUPERIORITY|||||||0.0202|||||||Wilcoxon (Mann-Whitney)|||||||0.0202
91538593|NCT01867580|182955353|SUPERIORITY|||||||0.0142|||||||Regression, Logistic|||||||0.0142
91538594|NCT01278862|182955354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2423|||||||Fisher Exact|||null hypothesis no difference in color match||||0.2423
91538595|NCT01278862|182955354|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in margin discoloration||||>0.999
91538596|NCT01278862|182955354|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in crown fracture||||>0.999
91538597|NCT01278862|182955354|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in Proximal Contact - Mesial||||>0.999
91763424|NCT01521507|183417302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|z-statistic|p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.||||<0.0001
91538598|NCT01278862|182955354|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in proximal contact - distal||||>0.999
91763425|NCT01521507|183417302|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0020
91763426|NCT01521507|183417303|SUPERIORITY_OR_OTHER|||||||0.9098|TWO_SIDED||||||Mixed Models Analysis|Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.||The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.9098
91763427|NCT01521507|183417304|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|t-test, 2 sided|||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.||||0.0068
91763428|NCT01521507|183417304|SUPERIORITY_OR_OTHER|||||||0.0419|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0419
91763429|NCT01521507|183417305|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED|||||Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.|Mixed Models Analysis|||The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.0237
91538599|NCT01278862|182955355|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in gingival index||||>0.999
91538600|NCT01278862|182955355|SUPERIORITY|||||||0.524|||||||Fisher Exact|||null hypothesis no difference in plaque index||||0.5240
91538601|NCT04520165|182955356|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
91538602|NCT04520165|182955358|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
91538603|NCT04520165|182955359|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
91538604|NCT03686813|182955461|OTHER|||||||0.317|||||||McNemar|||||||0.317
91538605|NCT03686813|182955462|OTHER|||||||0.317|||||||McNemar|||||||0.317
91538606|NCT03686813|182955463|OTHER||||||>|0.999|||||||McNemar|||||||>0.999
91538607|NCT03686813|182955464|OTHER|||||||0.18|||||||McNemar|||||||0.18
91538608|NCT03686813|182955465|OTHER|||||||0.29|||||||McNemar|||||||0.29
91538609|NCT00955825|182955473|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.126||||0.0003||95.0|-0.194|-0.058|||ANCOVA||Relative LS Means difference (%) = - 28.24|||-0.058|-0.194|0.0003
91538610|NCT01904071|182955481|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
91538611|NCT01904071|182955482|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
91538612|NCT01904071|182955483|SUPERIORITY_OR_OTHER||||||<|0.005|||||||ANOVA|||||||<.005
91538613|NCT01904071|182955484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<.001
91538614|NCT01904071|182955485|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANOVA|||||||0.342
91538615|NCT04035668|182955486|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.002|TWO_SIDED|95.0|-4.71|-1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|||-1.01|-4.71|0.002
91538616|NCT04035668|182955486|OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.24|1.25|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|||1.25|-3.24|
91538617|NCT04035668|182955487|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.065|TWO_SIDED|95.0|-2.29|0.3||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.30|-2.29|0.065
91538618|NCT04035668|182955487|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.01|TWO_SIDED|95.0|-3.24|-0.29||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||-0.29|-3.24|0.010
91538619|NCT04035668|182955487|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.289|TWO_SIDED|95.0|-2.17|1.22||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||1.22|-2.17|0.289
91538620|NCT04035668|182955487|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.093|TWO_SIDED|95.0|-2.97|0.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.59|-2.97|0.093
91538621|NCT04035668|182955487|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.094|TWO_SIDED|95.0|-2.84|0.57||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.57|-2.84|0.094
91538622|NCT04035668|182955487|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.012|TWO_SIDED|95.0|-3.71|-0.28||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|-0.28|-3.71|0.012
91538623|NCT04035668|182955487|OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-2.1|0.84|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.84|-2.10|
91538624|NCT04035668|182955487|OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-1.75|1.69|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||1.69|-1.75|
91538625|NCT04035668|182955487|OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.83|2.21|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||2.21|-1.83|
91538626|NCT04035668|182955487|OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.2|1.01|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||1.01|-3.20|
91538627|NCT04035668|182955487|OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|95.0|-3.5|0.6|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.60|-3.50|
91538628|NCT04035668|182955487|OTHER||Mean Difference (Final Values)|-1.14|||||TWO_SIDED|95.0|-3.22|0.95|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.95|-3.22|
91538629|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.46|TWO_SIDED|95.0|-0.69|0.62||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.62|-0.69|0.460
91538630|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.418|TWO_SIDED|95.0|-0.82|0.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||0.66|-0.82|0.418
91538631|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.466|TWO_SIDED|95.0|-0.76|0.7||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||0.70|-0.76|0.466
91538632|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.56|TWO_SIDED|95.0|-0.67|0.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.79|-0.67|0.560
91538633|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.616|TWO_SIDED|95.0|-0.73|0.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.99|-0.73|0.616
91538634|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.581|TWO_SIDED|95.0|-0.81|0.99||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|0.99|-0.81|0.581
91538635|NCT04035668|182955488|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.663|TWO_SIDED|95.0|-0.62|0.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||0.96|-0.62|0.663
91538636|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-1.35|0.11|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.11|-1.35|
91538637|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.42|0.26|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||0.26|-1.42|
91538638|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-1.31|0.42|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||0.42|-1.31|
91538639|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-1.44|0.31|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||0.31|-1.44|
91538640|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.65|-1.39|
91538641|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.65|-1.39|
91538642|NCT04035668|182955488|OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.37|0.57|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||0.57|-1.37|
91538643|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|-2.73||||0.94|TWO_SIDED|95.0|-6.18|0.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.73|-6.18|0.940
91538644|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.322|TWO_SIDED|95.0|-2.95|4.74||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||4.74|-2.95|0.322
91538645|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.753|TWO_SIDED|95.0|-5.32|2.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||2.59|-5.32|0.753
91538646|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.891|TWO_SIDED|95.0|-7.13|1.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||1.66|-7.13|0.891
91538647|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.941|TWO_SIDED|95.0|-8.77|1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||1.01|-8.77|0.941
91538648|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.304|TWO_SIDED|95.0|-4.01|6.79||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|6.79|-4.01|0.304
91538649|NCT04035668|182955489|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.64|TWO_SIDED|95.0|-6.89|4.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||4.79|-6.89|0.640
91538650|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|2.32|||||TWO_SIDED|95.0|-1.44|6.07|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||6.07|-1.44|
91538651|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-3.46|5.18|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||5.18|-3.46|
91538652|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.43|4.83|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||4.83|-4.43|
91538653|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|0.63|||||TWO_SIDED|95.0|-4.53|5.78|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.78|-4.53|
91538654|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|-4.6|6.82|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||6.82|-4.60|
91538655|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|5.69|||||TWO_SIDED|95.0|-0.66|12.04|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||12.04|-0.66|
91538656|NCT04035668|182955489|OTHER||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-3.53|10.59|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||10.59|-3.53|
91538657|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.494|TWO_SIDED|95.0|-7.84|7.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||7.96|-7.84|0.494
91538658|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|-3.87||||0.866|TWO_SIDED|95.0|-10.81|3.06||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||3.06|-10.81|0.866
91538659|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.684|TWO_SIDED|95.0|-9.37|5.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||5.73|-9.37|0.684
91538660|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.908|TWO_SIDED|95.0|-10.93|2.14||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||2.14|-10.93|0.908
91538661|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.487|TWO_SIDED|95.0|-8.0|8.26||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||8.26|-8.00|0.487
91538662|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|-3.06||||0.79|TWO_SIDED|95.0|-10.61|4.49||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|4.49|-10.61|0.790
91538663|NCT04035668|182955490|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.34|TWO_SIDED|95.0|-6.48|9.88||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||9.88|-6.48|0.340
91538664|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-9.06|8.68|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||8.68|-9.06|
91538665|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-9.59|6.17|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||6.17|-9.59|
91538666|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-9.34|8.74|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||8.74|-9.34|
91538667|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-3.94|||||TWO_SIDED|95.0|-11.74|3.86|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||3.86|-11.74|
91538668|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-4.71|||||TWO_SIDED|95.0|-14.34|4.93|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||4.93|-14.34|
91538669|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-6.29|||||TWO_SIDED|95.0|-15.44|2.87|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||2.87|-15.44|
91538670|NCT04035668|182955490|OTHER||Mean Difference (Final Values)|-3.92|||||TWO_SIDED|95.0|-14.01|6.16|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||6.16|-14.01|
91538671|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.575|TWO_SIDED|95.0|-6.75|8.16||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||8.16|-6.75|0.575
91538672|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|-1.98||||0.294|TWO_SIDED|95.0|-9.22|5.27||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||5.27|-9.22|0.294
91538673|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.45|TWO_SIDED|95.0|-8.4|7.41||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||7.41|-8.40|0.450
91538674|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.913|TWO_SIDED|95.0|-2.74|14.78||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||14.78|-2.74|0.913
91538675|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|2.59||||0.722|TWO_SIDED|95.0|-6.16|11.34||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||11.34|-6.16|0.722
91538676|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.241|TWO_SIDED|95.0|-10.96|5.24||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|5.24|-10.96|0.241
91538677|NCT04035668|182955491|SUPERIORITY||Mean Difference (Final Values)|2.95||||0.742|TWO_SIDED|95.0|-6.09|11.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||11.99|-6.09|0.742
91538678|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-8.28|7.91|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||7.91|-8.28|
91538679|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-8.87|7.58|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||7.58|-8.87|
91538680|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-9.28|9.48|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||9.48|-9.28|
91538681|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|-4.4|||||TWO_SIDED|95.0|-14.71|5.9|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.90|-14.71|
91538682|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-22.47|-1.77|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||-1.77|-22.47|
91763430|NCT04034004|183417306|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.||||.05
91538683|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-16.0|3.5|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||3.50|-16.00|
91538684|NCT04035668|182955491|OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-19.16|2.96|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||2.96|-19.16|
91538685|NCT00004124|182955508|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|||||1.43|0.79|0.70
91538686|NCT00004124|182955509|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.8|1.27|||Regression, Cox|||||1.27|0.80|0.94
91538687|NCT03262935|182955535|SUPERIORITY||Hazard Ratio (HR)|0.6401|||=|0.002|TWO_SIDED|95.0|0.4885|0.8389||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||0.8389|0.4885|=0.002
91538688|NCT03262935|182955536|SUPERIORITY||Hazard Ratio (HR)|0.868|||=|0.236|TWO_SIDED|95.0|0.676|1.1145||P-value from stratified log-rank test for Kaplan-Meier estimate of median OS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of OS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||1.1145|0.676|=0.236
91538689|NCT03262935|182955537|SUPERIORITY||||||=|0.732||||||P-value from Cochran-Mantel-Haenszel test including the randomization stratification factors.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel test (strata based on the baseline stratification factors) was used to compare the two treatment groups with respect to the ORR at two-sided 5% level of significance.||||=0.732
91538690|NCT03262935|182955538|SUPERIORITY||Hazard Ratio (HR)|0.5995|||<|0.001|TWO_SIDED|95.0|0.4666|0.7703||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the HR of PFS, along with the 95% CI. The treatment groups were compared using the 2-sided stratified log-rank test.||0.7703|0.4666|<0.001
91538691|NCT03262935|182955539|SUPERIORITY|||||||0.473|||||||MMRM|||The change from baseline in the global health status/QoL scale transformed score was analyzed using a mixed model repeated measurement (MMRM) approach.||||0.473
91538692|NCT01811706|182955542|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of T25FW between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
91538693|NCT01811706|182955543|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of SARA score between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
91763431|NCT04317040|183417312|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.398||||0.0367|TWO_SIDED|95.0|1.02|1.918|||Log Rank||Cox-Regression Model|||1.918|1.020|0.0367
91763432|NCT04317040|183417314|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0555||||0.3281|TWO_SIDED|95.0|-0.1665|0.0555|||Chi-squared||Mantel-Haenszel method|||0.0555|-0.1665|0.3281
91538694|NCT01811706|182955544|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of Stride Length on BAG between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
91538695|NCT00545844|182955584|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91538696|NCT00545844|182955585|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91538697|NCT00545844|182955586|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
91538698|NCT00545844|182955587|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
91538699|NCT00545844|182955588|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
91538700|NCT02503202|182955596|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot B)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.14||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.14|0.77|<0.001
91538701|NCT02503202|182955596|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot C)|0.88|||<|0.001|TWO_SIDED|95.0|0.71|1.09||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.09|0.71|<0.001
91538702|NCT02503202|182955596|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot B / Lot C)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.15||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.15|0.77|<0.001
91538703|NCT02503202|182955597|OTHER||Risk Difference (RD)|1.1||||0.368|TWO_SIDED|95.0|-1.5|4.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||4.0|-1.5|0.368
91538704|NCT02503202|182955597|OTHER||Risk Difference (RD)|0.0||||0.989|TWO_SIDED|95.0|-3.1|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-3.1|0.989
91538705|NCT02503202|182955597|OTHER||Risk Difference (RD)|-1.1||||0.361|TWO_SIDED|95.0|-4.1|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.5|-4.1|0.361
91538706|NCT02503202|182955597|OTHER||Risk Difference (RD)|1.2||||0.214|TWO_SIDED|95.0|-1.7|3.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.3|-1.7|0.214
91538707|NCT02503202|182955598|OTHER||Risk Difference (RD)|4.1||||0.16|TWO_SIDED|95.0|-1.6|9.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site erythema||9.9|-1.6|0.160
91538708|NCT02503202|182955598|OTHER||Risk Difference (RD)|-0.1||||0.971|TWO_SIDED|95.0|-6.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site erythema||6.0|-6.2|0.971
91538709|NCT02503202|182955598|OTHER||Risk Difference (RD)|-4.2||||0.151|TWO_SIDED|95.0|-10.0|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site erythema||1.5|-10.0|0.151
91538710|NCT02503202|182955598|OTHER||Risk Difference (RD)|5.8||||0.016|TWO_SIDED|95.0|1.4|9.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site erythema||9.9|1.4|0.016
91538711|NCT02503202|182955598|OTHER||Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-14.0|1.6|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site pain||1.6|-14.0|0.120
91538712|NCT02503202|182955598|OTHER||Risk Difference (RD)|-3.5||||0.38|TWO_SIDED|94.0|-11.4|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site pain||4.4|-11.4|0.380
91538713|NCT02503202|182955598|OTHER||Risk Difference (RD)|2.7||||0.499|TWO_SIDED|95.0|-5.1|10.4|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site pain||10.4|-5.1|0.499
91538714|NCT02503202|182955598|OTHER||Risk Difference (RD)|54.9|||<|0.001|TWO_SIDED|95.0|46.2|62.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site pain||62.3|46.2|<0.001
91538715|NCT02503202|182955598|OTHER||Risk Difference (RD)|4.0||||0.202|TWO_SIDED|95.0|-2.2|10.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site swelling||10.3|-2.2|0.202
91538716|NCT02503202|182955598|OTHER||Risk Difference (RD)|-0.5||||0.878|TWO_SIDED|95.0|-7.1|6.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site swelling||6.1|-7.1|0.878
91538717|NCT02503202|182955598|OTHER||Risk Difference (RD)|-4.6||||0.154|TWO_SIDED|95.0|-10.9|1.7|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site swelling||1.7|-10.9|0.154
91538718|NCT02503202|182955598|OTHER||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|18.6|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site swelling||18.6|7.4|<0.001
91538719|NCT02503202|182955599|OTHER||Risk Difference (RD)|4.6||||0.176|TWO_SIDED|95.0|-2.1|11.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||11.4|-2.1|0.176
91763433|NCT04317040|183417315|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.558||||0.0306|TWO_SIDED|95.0|0.327|0.954|||Log Rank||Cox Regression Model|||0.954|0.327|0.0306
91538720|NCT02503202|182955599|OTHER||Risk Difference (RD)|-1.1||||0.769|TWO_SIDED|95.0|-8.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||6.0|-8.2|0.769
91538721|NCT02503202|182955599|OTHER||Risk Difference (RD)|-5.7||||0.1|TWO_SIDED|95.0|-12.5|1.1|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.1|-12.5|0.100
91538722|NCT02503202|182955599|OTHER||Risk Difference (RD)|31.4|||<|0.001|TWO_SIDED|95.0|25.6|37.5|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||37.5|25.6|<0.001
91538723|NCT02503202|182955600|OTHER||Risk Difference (RD)|0.0||||0.983|TWO_SIDED|95.0|-4.2|4.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthralgia||4.1|-4.2|0.983
91538724|NCT02503202|182955600|OTHER||Risk Difference (RD)|-0.8||||0.699|TWO_SIDED|95.0|-5.1|3.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthralgia||3.4|-5.1|0.699
91538725|NCT02503202|182955600|OTHER||Risk Difference (RD)|-0.8||||0.716|TWO_SIDED|95.0|-5.1|3.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthralgia||3.5|-5.1|0.716
91538726|NCT02503202|182955600|OTHER||Risk Difference (RD)|6.2||||0.012|TWO_SIDED|95.0|1.8|10.4|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthralgia||10.4|1.8|0.012
91538727|NCT02503202|182955600|OTHER||Risk Difference (RD)|0.7||||0.677|TWO_SIDED|95.0|-2.9|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthritis||4.4|-2.9|0.677
91538728|NCT02503202|182955600|OTHER||Risk Difference (RD)|1.9||||0.25|TWO_SIDED|95.0|-1.4|5.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthritis||5.4|-1.4|0.250
91538729|NCT02503202|182955600|OTHER||Risk Difference (RD)|1.1||||0.46|TWO_SIDED|95.0|-2.1|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthritis||4.5|-2.1|0.460
91538730|NCT02503202|182955600|OTHER||Risk Difference (RD)|3.1||||0.041|TWO_SIDED|95.0|0.2|6.0|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthritis||6.0|0.2|0.041
91538731|NCT02503202|182955601|OTHER||Risk Difference (RD)|-1.5||||0.353|TWO_SIDED|95.0|-5.1|1.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||1.9|-5.1|0.353
91538732|NCT02503202|182955601|OTHER||Risk Difference (RD)|-0.8||||0.62|TWO_SIDED|95.0|-4.2|2.5|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||2.5|-4.2|0.620
91538733|NCT02503202|182955601|OTHER||Risk Difference (RD)|0.8||||0.663|TWO_SIDED|95.0|-2.9|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||4.5|-2.9|0.663
91538734|NCT02503202|182955601|OTHER||Risk Difference (RD)|2.3||||0.202|TWO_SIDED|95.0|-1.8|5.7|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||5.7|-1.8|0.202
91538735|NCT02503202|182955602|OTHER||Risk Difference (RD)|0.7||||0.483|TWO_SIDED|95.0|-1.6|3.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||3.3|-1.6|0.483
91538736|NCT02503202|182955602|OTHER||Risk Difference (RD)|0.4||||0.746|TWO_SIDED|95.0|-2.2|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-2.2|0.746
91538737|NCT02503202|182955602|OTHER||Risk Difference (RD)|-0.4||||0.704|TWO_SIDED|95.0|-2.8|2.0|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||2.0|-2.8|0.704
91538738|NCT02503202|182955602|OTHER||Risk Difference (RD)|1.5||||0.151|TWO_SIDED|95.0|-1.3|3.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.9|-1.3|0.151
91538739|NCT00371566|182955608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.93||0.394||95.0|-5.5|2.19|||ANCOVA|Null hypothesis or reject it in favor of the two sided alternative hypothesis||The study was designed to provide evidence to support the null hypothesis: Delta equals 0% or reject it in favor of the two sided alternative hypothesis: Delta does not equal 0%, where Delta was the difference in the true response rate for the two treatment groups.||2.19|-5.50|.394
91538740|NCT05565391|182955641|OTHER||Risk Ratio (RR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.54|2.47|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.47|1.54|<.0001
91538741|NCT05565391|182955641|OTHER||Risk Ratio (RR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.52|2.67|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.67|1.52|<.0001
91538742|NCT05565391|182955642|OTHER||Risk Ratio (RR)|2.22|||<|0.0001|TWO_SIDED|95.0|1.69|2.9|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||2.90|1.69|<.0001
91538743|NCT05565391|182955643|OTHER||Risk Ratio (RR)|1.79||||0.0447|TWO_SIDED|95.0|1.01|3.15|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||3.15|1.01|0.0447
91538744|NCT05565391|182955644|OTHER|||||||0.4241|||||||Quantile regression|||||||0.4241
91538745|NCT05565391|182955644|OTHER|||||||0.0281|||||||Quantile regression|||||||0.0281
91538746|NCT05565391|182955645|OTHER|||||||0.7682|||||||Quantile regression|||||||0.7682
91538747|NCT05565391|182955646|OTHER|||||||0.0326|||||||Quantile regression|||||||0.0326
91538748|NCT05565391|182955647|OTHER||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.31|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.31|0.09|<.0001
91538749|NCT05565391|182955647|OTHER||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.11|0.43|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.43|0.11|<.0001
91538750|NCT05565391|182955648|OTHER||Hazard Ratio (HR)|0.11|||<|0.0001|TWO_SIDED|95.0|0.06|0.22|||Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.22|0.06|<.0001
91538751|NCT05565391|182955649|OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.1|0.45|||Weighted Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.45|0.10|<.0001
91538752|NCT00530842|182955651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.044||0.0482|TWO_SIDED|95.0|-0.174|-0.001|||ANOVA|ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.||||-0.001|-0.174|0.0482
91538753|NCT00530842|182955652|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0||||0.3407|TWO_SIDED|95.0|-9.5|27.5|||Wilcoxon signed-rank test||The confidence interval was determined by Hodges-Lehmann method.|||27.5|-9.5|0.3407
91538754|NCT03399370|182955719|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-57.64|||<|0.0001|TWO_SIDED|95.0|-60.86|-54.43||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-54.43|-60.86|<.0001
91538755|NCT03399370|182955720|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-53.78|||<|0.0001|TWO_SIDED|95.0|-56.23|-51.33||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-51.33|-56.23|<0.0001
91538756|NCT03399370|182955721|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-54.12|||<|0.0001|TWO_SIDED|95.0|-57.37|-50.88||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.88|-57.37|<0.0001
91538757|NCT03399370|182955722|SUPERIORITY||Mean Difference (Final Values)|-53.28|||<|0.0001|TWO_SIDED|95.0|-55.75|-50.8||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.80|-55.75|<0.0001
91538758|NCT03399370|182955723|SUPERIORITY||Mean Difference (Final Values)|-83.8|||<|0.0001|TWO_SIDED|95.0|-89.25|-77.34||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-77.34|-89.25|<0.0001
91538759|NCT03399370|182955724|SUPERIORITY||Mean Difference (Final Values)|-33.13|||<|0.0001|TWO_SIDED|95.0|-35.3|-30.97||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-30.97|-35.30|<0.0001
91538760|NCT03399370|182955725|SUPERIORITY||Mean Difference (Final Values)|-43.09|||<|0.0001|TWO_SIDED|95.0|-45.5|-40.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.67|-45.50|<.0001
91538761|NCT03399370|182955726|SUPERIORITY||Mean Difference (Final Values)|-47.36|||<|0.0001|TWO_SIDED|95.0|-50.25|-44.47||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-44.47|-50.25|<0.0001
91538762|NCT05819190|182955739|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - FAS set||||0.0192
91538763|NCT05819190|182955740|SUPERIORITY|||||||0.0296|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - PP set||||0.0296
91538764|NCT05819190|182955741|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||||||0.0085
91538765|NCT05819190|182955742|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||||||0.0081
91538766|NCT05819190|182955743|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.0050
91538767|NCT05819190|182955744|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||||||0.0107
91538768|NCT05819190|182955745|SUPERIORITY|||||||0.0424|||||||Wilcoxon (Mann-Whitney)|||||||0.0424
91538769|NCT05819190|182955746|SUPERIORITY|||||||0.43||||||one sided test|Wilcoxon (Mann-Whitney)|||0.05 global significance level (type I error rate)||||0.430
91538770|NCT05819190|182955747|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.339
91538771|NCT05819190|182955748|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.704
91538772|NCT05819190|182955749|SUPERIORITY|||||||0.298|||||||Wilcoxon (Mann-Whitney)|One sided test||0.05 global significance level (type I error rate)||||0.298
91538773|NCT05819190|182955750|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.906
91538774|NCT05819190|182955751|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.582
91538775|NCT05819190|182955752|SUPERIORITY|||||||0.743|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.743
91538776|NCT05819190|182955753|SUPERIORITY|||||||0.605|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.605
91538777|NCT05819190|182955754|SUPERIORITY|||||||1|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||1.000
91538778|NCT05819190|182955755|SUPERIORITY|||||||0.988|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.988
91763434|NCT04317040|183417316|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|0.027||||0.4491|TWO_SIDED|95.0|-0.043|0.097|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 15|Day 15||0.0970|-0.0430|0.4491
91538779|NCT05819190|182955756|SUPERIORITY|||||||0.483|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||0.483
91538780|NCT01656304|182955759|SUPERIORITY_OR_OTHER||Rate|0.333|STANDARD_ERROR_OF_MEAN|0.1217|||TWO_SIDED|80.0|0.2|0.5||||||||.50|.20|
91763435|NCT04317040|183417316|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0146||||0.7512|TWO_SIDED|95.0|-0.1049|0.0756|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 29|Day 29||0.0756|-0.1049|0.7512
91513935|NCT05349617|182899919|SUPERIORITY||[GMT Ratio]|90.0|||<|0.0001|TWO_SIDED|95.0|69.0|117.0||Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo).|Day 22||117|69|<0.0001
91513936|NCT05349617|182899925|SUPERIORITY||Percent Difference|79.5|||<|0.0001|TWO_SIDED|95.0|72.3|84.6||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||84.6|72.3|<0.0001
91513937|NCT05349617|182899925|SUPERIORITY||Percent Difference|74.4|||<|0.0001|TWO_SIDED|95.0|67.1|80.1||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||80.1|67.1|<0.0001
91513938|NCT05349617|182899926|SUPERIORITY||[GMT Ratio]|42.0|||<|0.0001|TWO_SIDED|95.0|32.0|56.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 15||56|32|<0.0001
91513939|NCT05349617|182899926|SUPERIORITY||[GMT Ratio]|28.0|||<|0.0001|TWO_SIDED|95.0|22.0|35.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 183||35|22|<0.0001
91513940|NCT05349617|182899927|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
91513941|NCT05349617|182899927|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
91513942|NCT05349617|182899927|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
91513943|NCT05349617|182899928|SUPERIORITY||Percent Difference|91.6|||<|0.0001|TWO_SIDED|95.0|86.0|94.6|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||94.6|86.0|<0.0001
91513944|NCT05349617|182899928|SUPERIORITY||Percent Difference|94.1|||<|0.0001|TWO_SIDED|95.0|89.2|96.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||96.5|89.2|<0.0001
91513945|NCT05349617|182899928|SUPERIORITY||Percent Difference|91.8|||<|0.0001|TWO_SIDED|95.0|86.3|94.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||94.8|86.3|<0.0001
91513946|NCT05349617|182899928|SUPERIORITY||Percent Difference|82.8|||<|0.0001|TWO_SIDED|95.0|75.9|87.5||p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|Chi-squared||SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||87.5|75.9|<0.0001
91513947|NCT05349617|182899928|SUPERIORITY||Percent Difference|88.3|||<|0.0001|TWO_SIDED|95.0|82.4|92.0|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||92.0|82.4|<0.0001
91513948|NCT05349617|182899928|SUPERIORITY||Percent Difference|82.0|||<|0.0001|TWO_SIDED|95.0|75.2|86.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||86.8|75.2|<0.0001
91513949|NCT00746954|182899929|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANOVA|||Comparisons among groups||||0.45
91513950|NCT04401579|182899934|SUPERIORITY||Cox Proportional Hazard|1.15||||0.047|TWO_SIDED|95.0|1.0|1.31|||Log Rank|||||1.31|1.00|0.047
91513951|NCT04401579|182899950|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-12.0|0.0||||||||0|-12|
91513952|NCT04401579|182899951|SUPERIORITY||Risk Difference (RD)|-5.0|||||TWO_SIDED|95.0|-10.0|0.0||||||||0|-10|
91513953|NCT04401579|182899961|SUPERIORITY||Odds Ratio (OR)|1.26||||0.44|TWO_SIDED|95.0|1.01|1.57|||Regression, Logistic|||||1.57|1.01|0.44
91513954|NCT04401579|182899971|SUPERIORITY||Cox Proportional Hazard|1.21||||0.002|TWO_SIDED|95.0|1.06|1.39|||Log Rank|||||1.39|1.06|0.002
91513955|NCT04401579|182899972|SUPERIORITY||Cox Proportional Hazard|1.2||||0.005|TWO_SIDED|95.0|1.05|1.38|||Log Rank|||||1.38|1.05|0.005
91513956|NCT04401579|182899973|SUPERIORITY||Cox Proportional Hazard|1.24||||0.003|TWO_SIDED|95.0|1.07|1.44|||Log Rank|||||1.44|1.07|0.003
91763436|NCT04317040|183417319|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.416||||0.0311|TWO_SIDED|95.0|1.031|1.945|||Log Rank||Cox Regression model|||1.945|1.031|0.0311
91513957|NCT04401579|182899976|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||This analysis is for Asian participants.||1.68|0.73|
91513958|NCT04401579|182899976|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.75|1.5||||||This analysis is for Black or African American participants.||1.50|0.75|
91513959|NCT04401579|182899976|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.93|1.37||||||This analysis is for White participants.||1.37|0.93|
91513960|NCT04401579|182899976|SUPERIORITY||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.74||||||This analysis is for Race of Other participants.||1.74|1.03|
91513961|NCT04401579|182899977|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.08|1.6||||||This analysis is for Not Hispanic or Latino participants||1.60|1.08|
91513962|NCT04401579|182899977|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||This analysis is for Hispanic or Latino participants.||1.31|0.89|
91513963|NCT04401579|182899978|SUPERIORITY||Cox Proportional Hazard|1.23|||||TWO_SIDED|95.0|1.04|1.46||||||This analysis is for Male participants.||1.46|1.04|
91513964|NCT04401579|182899978|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||This analysis is for Female participants.||1.32|0.85|
91513965|NCT00489970|182899987|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.41|||||TWO_SIDED|97.5|-1.16|4.17|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.17|-1.16|
91513966|NCT00489970|182899987|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-1.52|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-1.52|
91513967|NCT00489970|182899987|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.32|||||TWO_SIDED|97.5|-3.41|4.15|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.15|-3.41|
91513968|NCT00489970|182899987|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-3.69|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-3.69|
91513969|NCT00489970|182899989|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.53|||||TWO_SIDED|97.5|1.31|1.79|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||1.79|1.31|
91513970|NCT00489970|182899989|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.62|6.01|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.01|4.62|
91513971|NCT00489970|182899989|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|3.62|||||TWO_SIDED|97.5|3.07|4.25|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||4.25|3.07|
91538781|NCT01093534|182955789|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.169||||0.095|TWO_SIDED|95.0|-0.368|0.03||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|ANCOVA|ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.||The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)||0.030|-0.368|0.095
91538782|NCT01093534|182955790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|Wilcoxon (Mann-Whitney)|Nonparametric Wilcoxon rank-sum test does not adjust for other factors.||The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).||||0.250
91538783|NCT05147233|182955856|SUPERIORITY||Difference in Percentages|33.2|||<|0.0001|TWO_SIDED|95.0|21.5|44.9|||Wald test|||||44.9|21.5|<0.0001
91538784|NCT05147233|182955857|SUPERIORITY||Difference in Percentages|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Wald test|||||35.3|11.7|<0.0001
91538785|NCT02878850|182955865|SUPERIORITY||Mean Difference (Final Values)|2.95||||0.55|TWO_SIDED|95.0|-6.85|12.75|||t-test, 2 sided|||||12.75|-6.85|0.55
91538786|NCT02878850|182955866|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.92|TWO_SIDED|95.0|-12.48|11.21|||ANCOVA|||||11.21|-12.48|0.92
91538787|NCT02878850|182955867|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.75|TWO_SIDED|95.0|-1.83|2.53|||ANCOVA|||||2.53|-1.83|0.75
91538788|NCT02878850|182955868|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.4|TWO_SIDED|95.0|-2.64|6.53|||ANCOVA|||||6.53|-2.64|0.40
91538789|NCT02878850|182955869|SUPERIORITY||Risk Ratio (RR)|2.0|||<|0.001||95.0|1.36|2.94|||Chi-squared|||||2.94|1.36|<0.001
91538790|NCT02878850|182955870|SUPERIORITY||Risk Ratio (RR)|1.08||||0.87|TWO_SIDED|95.0|0.44|3.65|||Chi-squared|||||3.65|0.44|0.87
91538791|NCT02878850|182955871|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.08|TWO_SIDED|95.0|-0.08|1.32|||ANCOVA|||||1.32|-0.08|0.08
91538792|NCT02878850|182955872|SUPERIORITY||Mean Difference (Final Values)|-5.73||||0.35|TWO_SIDED|95.0|-16.84|6.1|||t-test, 2 sided|||||6.10|-16.84|0.35
91538793|NCT02878850|182955873|SUPERIORITY||Mean Difference (Final Values)|-35.37||||0.04|TWO_SIDED|95.0|-68.87|-1.87|||t-test, 2 sided|||||-1.87|-68.87|0.04
91538794|NCT04517864|182955874|SUPERIORITY||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.056|0.097||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.097|-0.056|
91538795|NCT04517864|182955875|SUPERIORITY||Least Squares Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0307|||TWO_SIDED|95.0|-0.052|0.07||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.070|-0.052|
91538796|NCT04517864|182955876|SUPERIORITY||Least Squares Mean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.0297|||TWO_SIDED|95.0|-0.065|0.053||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.053|-0.065|
91538797|NCT04517864|182955878|SUPERIORITY||Least Squares Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.0235|||TWO_SIDED|95.0|-0.005|0.088||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.088|-0.005|
91538798|NCT04517864|182955884|SUPERIORITY||Least Squares Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0224|||TWO_SIDED|95.0|-0.059|0.03||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.030|-0.059|
91538799|NCT04517864|182955884|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.107|-0.012||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||-0.012|-0.107|
91538800|NCT04517864|182955886|SUPERIORITY||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0242|||TWO_SIDED|95.0|-0.076|0.02||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.020|-0.076|
91538801|NCT04517864|182955886|SUPERIORITY||Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|-0.049|0.056||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||0.056|-0.049|
91538802|NCT04541303|182955910|SUPERIORITY|||||||0.028|||||||None specified|||||||.028
91538803|NCT03351075|182955920|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5163|TWO_SIDED|95.0|-5.28|2.65||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The sample size was based on comparing the changes for the primary outcome measure (PDI-DLV) at 12 months after surgery. The calculation was based on comparing the values at 12 months. Assuming a coefficient of variation (CV) equal to 0.5, 87 participants per group were needed based on a two-sample pooled t-test of a mean ratio with lognormal data and α=0.05 to detect with 80% power a difference of 20% in PDI. To anticipate a drop-out ratio of 5%, a total of 184 subjects were needed.||2.65|-5.28|0.5163
91538804|NCT03351075|182955921|SUPERIORITY||Mean Difference (Net)|-0.97||||0.5655|TWO_SIDED|95.0|-4.26|2.33||No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 4 months||2.33|-4.26|0.5655
91538805|NCT03351075|182955921|SUPERIORITY||Mean Difference (Net)|-1.07||||0.5592|TWO_SIDED|95.0|-4.64|2.51||P\<.05 was considered significant. No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 1.5 years||2.51|-4.64|0.5592
91538806|NCT03351075|182955922|SUPERIORITY||Mean Difference (Net)|-2.23||||0.563|TWO_SIDED|95.0|-9.84|5.37||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 4 months||5.37|-9.84|0.5630
91538807|NCT03351075|182955922|SUPERIORITY||Mean Difference (Net)|-4.3||||0.2524|TWO_SIDED|95.0|-11.68|3.09||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 12 months||3.09|-11.68|0.2524
91538808|NCT03351075|182955922|SUPERIORITY||Mean Difference (Net)|-4.8||||0.2315|TWO_SIDED|95.0|-12.69|3.09|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 1.5 years||3.09|-12.69|0.2315
91538809|NCT03351075|182955923|SUPERIORITY||Mean Difference (Net)|0.47||||0.7494|TWO_SIDED|95.0|-2.39|3.32||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 4 months.||3.32|-2.39|0.7494
91538810|NCT03351075|182955923|SUPERIORITY||Mean Difference (Net)|-0.25||||0.8617|TWO_SIDED|95.0|-3.09|2.58|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The difference in change in self-reported central sensitisation symptoms from baseline to 12 months.||2.58|-3.09|0.8617
91538811|NCT03351075|182955923|SUPERIORITY||Mean Difference (Net)|-0.29||||0.8454|TWO_SIDED|95.0|-3.16|2.59|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 1.5 years||2.59|-3.16|0.8454
91538812|NCT03351075|182955924|SUPERIORITY||Mean Difference (Net)|1.35||||0.3463|TWO_SIDED|95.0|0.72|2.51|||multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 4 months||2.51|0.72|0.3463
91538813|NCT03351075|182955924|SUPERIORITY||Mean Difference (Net)|0.86||||0.6613|TWO_SIDED|95.0|0.451|1.66|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1 year||1.66|0.451|0.6613
91538814|NCT03351075|182955924|SUPERIORITY||Mean Difference (Net)|1.26||||0.4908|TWO_SIDED|95.0|0.65|2.42|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1.5 years||2.42|0.65|0.4908
91538815|NCT03351075|182955925|SUPERIORITY||Mean Difference (Net)|0.22||||0.7708|TWO_SIDED|95.0|-1.25|1.69|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 4 months||1.69|-1.25|0.7708
91538816|NCT03351075|182955925|SUPERIORITY||Mean Difference (Net)|0.29||||0.706|TWO_SIDED|95.0|-1.23|1.81|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 1 year||1.81|-1.23|0.7060
91538817|NCT03351075|182955925|SUPERIORITY||Mean Difference (Net)|0.02||||0.9806|TWO_SIDED|95.0|-1.38|1.42|||Multivariate linear model|||Difference in change in warmth detection sensitivity from baseline to 1.5 years||1.42|-1.38|0.9806
91538818|NCT03351075|182955926|SUPERIORITY||Mean Difference (Net)|0.74||||0.0284|TWO_SIDED|95.0|0.08|1.4|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 4 months||1.40|0.08|0.0284
91538819|NCT03351075|182955926|SUPERIORITY||Mean Difference (Net)|0.09||||0.7776|TWO_SIDED|95.0|-0.55|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1 year||0.73|-0.55|0.7776
91538820|NCT03351075|182955926|SUPERIORITY||Mean Difference (Net)|0.31||||0.3829|TWO_SIDED|95.0|-0.39|1.01|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1.5 years||1.01|-0.39|0.3829
91538821|NCT03351075|182955927|SUPERIORITY||Mean Difference (Net)|0.31||||0.1948|TWO_SIDED|95.0|-0.16|0.77|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 4 months||0.77|-0.16|0.1948
91538822|NCT03351075|182955927|SUPERIORITY||Mean Difference (Net)|0.17||||0.4937|TWO_SIDED|95.0|-0.31|0.65|||Multivariate linear model|||Difference in change in conditioned pain modulation from baseline to 1 year||0.65|-0.31|0.4937
91538823|NCT03351075|182955927|SUPERIORITY||Mean Difference (Net)|0.23||||0.369|TWO_SIDED|95.0|-0.27|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 1.5 years||0.73|-0.27|0.3690
91538824|NCT03351075|182955928|SUPERIORITY||Mean Difference (Net)|2.24||||0.2915|TWO_SIDED|95.0|-1.94|6.43|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 4 months||6.43|-1.94|0.2915
91538825|NCT03351075|182955928|SUPERIORITY||Mean Difference (Net)|-1.63||||0.4632|TWO_SIDED|95.0|-6.02|2.75|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1 year||2.75|-6.02|0.4632
91538826|NCT03351075|182955928|SUPERIORITY||Mean Difference (Net)|-3.16||||0.1944|TWO_SIDED|95.0|-7.94|1.63|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1,5 years||1.63|-7.94|0.1944
91538827|NCT03351075|182955929|SUPERIORITY||Mean Difference (Net)|-293.0||||0.5332|TWO_SIDED|95.0|-1218.0|632.0|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in step count from baseline to 4 months||632|-1218|0.5332
91538828|NCT03351075|182955929|SUPERIORITY||Mean Difference (Net)|839.0||||0.1201|TWO_SIDED|95.0|-221.0|1900.0|||Multivariate linear model|||Difference in change in step count from baseline to 1 year||1900|-221|0.1201
91538829|NCT03351075|182955930|SUPERIORITY||Mean Difference (Net)|0.831||||0.359|TWO_SIDED|95.0|0.561|1.233|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 4 months||1.233|0.561|0.3590
91538830|NCT03351075|182955930|SUPERIORITY||Mean Difference (Net)|0.839||||0.3744|TWO_SIDED|95.0|0.57|1.236|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1 year||1.236|0.570|0.3744
91538831|NCT03351075|182955930|SUPERIORITY||Median Difference (Net)|0.848||||0.4533|TWO_SIDED|95.0|0.522|1.304|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1.5 years||1.304|0.522|0.4533
91538832|NCT03351075|182955931|SUPERIORITY||Mean Difference (Net)|0.862||||0.5018|TWO_SIDED|95.0|0.558|1.33|||MUltivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 4 months||1.330|0.558|0.5018
91538833|NCT03351075|182955931|SUPERIORITY||Mean Difference (Net)|0.808||||0.3362|TWO_SIDED|95.0|0.522|1.248|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1 year||1.248|0.522|0.3362
91538834|NCT03351075|182955931|SUPERIORITY||Mean Difference (Net)|0.958||||0.8375|TWO_SIDED|95.0|0.633|1.449|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1.5 years||1.449|0.633|0.8375
91538835|NCT03351075|182955932|SUPERIORITY||Mean Difference (Net)|-0.32||||0.1745|TWO_SIDED|95.0|-0.78|0.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 4 months||0.14|-0.78|0.1745
91538836|NCT03351075|182955932|SUPERIORITY||Mean Difference (Net)|0.18||||0.5025|TWO_SIDED|95.0|-0.35|0.71|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1 year||0.71|-0.35|0.5025
91538837|NCT03351075|182955932|SUPERIORITY||Mean Difference (Net)|0.45||||0.1363|TWO_SIDED|95.0|-0.14|1.05|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1,5 years||1.05|-0.14|0.1363
91538838|NCT03351075|182955933|SUPERIORITY||Percentage|-0.184||||0.074|TWO_SIDED|95.0|-0.358|0.008|||Fisher Exact|||Difference in proportion of working participants at 1 year||0.008|-0.358|0.074
91538839|NCT03351075|182955933|SUPERIORITY||Percentage|-0.09||||0.352|TWO_SIDED|95.0|-0.26|0.078|||Fisher Exact|||Difference in proportion of working participants at 1,5 years||0.078|-0.26|0.352
91538840|NCT03351075|182955934|SUPERIORITY||Mean Difference (Net)|0.23||||0.8497|TWO_SIDED|95.0|-2.17|2.64|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 4 months||2.64|-2.17|0.8497
91538841|NCT03351075|182955934|SUPERIORITY||Mean Difference (Net)|0.81||||0.4971|TWO_SIDED|95.0|-1.52|3.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1 year||3.14|-1.52|0.4971
91538842|NCT03351075|182955934|SUPERIORITY||Mean Difference (Net)|0.45||||0.6831|TWO_SIDED|95.0|-1.72|2.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1.5 years||2.62|-1.72|0.6831
91538843|NCT03351075|182955935|SUPERIORITY||Mean Difference (Net)|4.78||||0.8584|TWO_SIDED|95.0|-47.72|57.28|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 4 months||57.28|-47.72|0.8584
91538844|NCT03351075|182955935|SUPERIORITY||Mean Difference (Net)|-57.25||||0.0353|TWO_SIDED|95.0|-110.57|-3.93|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1 year||-3.93|-110.57|0.0353
91538845|NCT03351075|182955935|SUPERIORITY||Mean Difference (Net)|-20.1||||0.4865|TWO_SIDED|95.0|-76.72|36.52|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1.5 years||36.52|-76.72|0.4865
91538846|NCT03351075|182955936|SUPERIORITY||Mean Difference (Net)|1.11||||0.1278|TWO_SIDED|95.0|0.97|1.27|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 4 months||1.27|0.97|0.1278
91538847|NCT03351075|182955936|SUPERIORITY||Mean Difference (Net)|1.11||||0.1875|TWO_SIDED|95.0|0.95|1.3|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1 year||1.30|0.95|0.1875
91538848|NCT03351075|182955936|SUPERIORITY||Mean Difference (Net)|1.05||||0.5612|TWO_SIDED|95.0|0.89|1.23|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1.5 years||1.23|0.89|0.5612
91538849|NCT03351075|182955937|SUPERIORITY||Mean Difference (Net)|1.089||||0.7902|TWO_SIDED|95.0|0.693|1.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 4 months||1.620|0.693|0.7902
91538850|NCT03351075|182955937|SUPERIORITY||Mean Difference (Net)|0.934||||0.7578|TWO_SIDED|95.0|0.604|1.443|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1 year||1.443|0.604|0.7578
91538851|NCT03351075|182955937|SUPERIORITY||Mean Difference (Net)|1.01||||0.96|TWO_SIDED|95.0|0.679|1.504|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1.5 years||1.504|0.679|0.9600
91538852|NCT03351075|182955938|SUPERIORITY||Mean Difference (Net)|1.068||||0.7619|TWO_SIDED|95.0|0.696|1.639|||Multivariate linear model|multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 4 months||1.639|0.696|0.7619
91538853|NCT03351075|182955938|SUPERIORITY||Mean Difference (Net)|1.087||||0.7169|TWO_SIDED|95.0|0.702|1.673|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1 year||1.673|0.702|0.7169
91538854|NCT03351075|182955938|SUPERIORITY||Mean Difference (Net)|0.987||||0.9535|TWO_SIDED|95.0|0.639|1.525|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1.5 years||1.525|0.639|0.9535
91538855|NCT05219253|182955940|SUPERIORITY|The superiority was to be concluded if the lower limit (LL) of the 95% confidence interval (CI) of the adjusted GMC ratio between the HZ/su Group and Placebo Group for anti-gE antibody concentrations was equal to or above (\>=) 3.|GMC Ratio|19.8|||||TWO_SIDED|95.0|14.09|27.82|||ANOVA|||To demonstrate the immunogenicity of HZ/su vaccine compared to Placebo, in terms of anti-gE GMCs, at 1 month post-Dose 2 of study intervention administration (Month 3).||27.82|14.09|
91538856|NCT03086369|182955952|SUPERIORITY||Hazard Ratio (HR)|1.054||||0.7902|TWO_SIDED|95.0|0.728|1.527|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.527|0.728|0.7902
91538857|NCT03086369|182955956|SUPERIORITY||Hazard Ratio (HR)|1.192||||0.3771|TWO_SIDED|95.0|0.806|1.764|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.764|0.806|0.3771
91538858|NCT03086369|182955959|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.017|TWO_SIDED|95.0|0.175|0.872|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).||||0.872|0.175|0.017
91538859|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|0.718||||0.288|TWO_SIDED|95.0|0.392|1.317|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Appetite loss||1.317|0.392|0.288
91538860|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|0.788||||0.442|TWO_SIDED|95.0|0.423|1.468|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Constipation||1.468|0.423|0.442
91538861|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.883|TWO_SIDED|95.0|0.612|1.755|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Diarrhoea||1.755|0.612|0.883
91538862|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.803|TWO_SIDED|95.0|0.532|1.636|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Dyspnoea||1.636|0.532|0.803
91538863|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|1.053||||0.805|TWO_SIDED|95.0|0.675|1.645|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Fatigue||1.645|0.675|0.805
91538864|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.465|TWO_SIDED|95.0|0.42|1.464|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Financial difficulties||1.464|0.420|0.465
91538865|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|1.457||||0.231|TWO_SIDED|95.0|0.787|2.698|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Insomnia||2.698|0.787|0.231
91538866|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|0.914||||0.748|TWO_SIDED|95.0|0.532|1.57|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Nausea and vomiting||1.570|0.532|0.748
91538867|NCT03086369|182955960|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.875|TWO_SIDED|95.0|0.491|1.827|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Pain||1.827|0.491|0.875
91538868|NCT03622580|182956070|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-2.0|1.6|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|
91538869|NCT03622580|182956070|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-1.1|2.5|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|
91538870|NCT03622580|182956070|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95||0.4699|TWO_SIDED|97.5|-2.8|1.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||1.4|-2.8|0.4699
91538871|NCT03622580|182956070|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.965|TWO_SIDED|97.5|-2.1|2.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.2|-2.1|0.9650
91538872|NCT03622580|182956070|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.7967|TWO_SIDED|97.5|-2.0|1.6||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|0.7967
91538873|NCT03622580|182956070|SUPERIORITY||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79||0.3772|TWO_SIDED|97.5|-1.1|2.5||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|0.3772
91538874|NCT03622580|182956071|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|10.2|||||TWO_SIDED|97.5|0.3|20.0||||||The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|
91538875|NCT03622580|182956071|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|6.1|||||TWO_SIDED|97.5|-3.6|15.8||||||The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|
91538876|NCT03622580|182956071|SUPERIORITY||Difference in CMH Weighted Percentage|7.2||||0.1761|TWO_SIDED|97.5|-4.6|18.9||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||18.9|-4.6|0.1761
91538877|NCT03622580|182956071|SUPERIORITY||Difference in CMH Weighted Percentage|4.8||||0.3539|TWO_SIDED|97.5|-6.7|16.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||16.3|-6.7|0.3539
91538878|NCT03622580|182956071|SUPERIORITY||Difference in CMH Weighted Percentage|10.2||||0.0237|TWO_SIDED|97.5|0.3|20.0||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|0.0237
91538879|NCT03622580|182956071|SUPERIORITY||Difference in CMH Weighted Percentage|6.1||||0.1677|TWO_SIDED|97.5|-3.6|15.8||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|0.1677
91538880|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|95.0|-10.0|4.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.9|-10.0|
91538881|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
91538882|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-8.6|7.9||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||7.9|-8.6|
91538883|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-7.4|8.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.8|-7.4|
91538884|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|-2.5|||||TWO_SIDED|95.0|-9.1|4.1||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.1|-9.1|
91538885|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.5|4.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.5|-8.5|
91538886|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-4.6|4.8||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.8|-4.6|
91538887|NCT03622580|182956074|OTHER||Difference in CMH Weighted Percentage|3.3|||||TWO_SIDED|95.0|-1.0|7.5||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.5|-1.0|
91538888|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|-5.2|||||TWO_SIDED|95.0|-14.0|3.5||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||3.5|-14.0|
91538889|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-7.0|10.3||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||10.3|-7.0|
91538890|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-9.5|9.5||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||9.5|-9.5|
91538891|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|2.1|||||TWO_SIDED|95.0|-7.1|11.3||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.3|-7.1|
91538892|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|-4.5|||||TWO_SIDED|95.0|-11.9|2.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.9|-11.9|
91538893|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|-7.2|||||TWO_SIDED|95.0|-14.6|0.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||0.2|-14.6|
91538894|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-5.5|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-5.5|
91538895|NCT03622580|182956079|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.0|-3.0|
91763437|NCT00799903|183417336|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.199|TWO_SIDED|95.1|0.85|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.85|0.199
91763438|NCT00799903|183417337|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.045|TWO_SIDED|95.0|0.82|1.0||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.00|0.82|0.045
91763439|NCT00799903|183417338|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.019|TWO_SIDED|95.0|0.84|0.98||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||0.98|0.84|0.019
91763440|NCT00799903|183417339|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.594|TWO_SIDED|95.0|0.83|1.11||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.11|0.83|0.594
91538896|NCT03622580|182956084|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-2.8|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-2.8|
91538897|NCT03622580|182956084|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.2|1.5||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.5|-2.2|
91538898|NCT03622580|182956084|OTHER||Difference in CMH Weighted Percentage|-1.8|||||TWO_SIDED|95.0|-4.6|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-4.6|
91538899|NCT03622580|182956084|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.2|
91538900|NCT03622580|182956084|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-4.5|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-4.5|
91763441|NCT00799903|183417340|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.108|TWO_SIDED|95.0|0.77|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.77|0.108
91538901|NCT03622580|182956084|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.4|-2.6|
91538902|NCT03622580|182956088|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-3.5|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.5|
91763442|NCT00799903|183417341|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.81|1.27||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.27|0.81|0.920
91763443|NCT00799903|183417342|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.397|TWO_SIDED|95.0|0.88|1.05||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.05|0.88|0.397
91763444|NCT00799903|183417343|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.87|TWO_SIDED|95.0|0.9|1.13||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.13|0.90|0.870
91763445|NCT02518971|183417344|OTHER|||||||0.345|||||||Chi-squared|||||||0.345
91763446|NCT02518971|183417345|OTHER|||||||0.378|||||||Student T-Test|||||||.378
91763447|NCT02518971|183417346|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91763448|NCT02518971|183417347|OTHER|||||||0.497|||||||Fisher Exact|||||||.497
91763449|NCT02518971|183417348|OTHER|||||||0.207|||||||Student T-test|||||||.207
91538903|NCT03622580|182956088|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.1|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.1|
91538904|NCT03622580|182956088|OTHER||Difference in CMH Weighted Percentage|-2.1|||||TWO_SIDED|95.0|-5.1|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-5.1|
91538905|NCT03622580|182956088|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.5|1.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.6|-3.5|
91538906|NCT03622580|182956088|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-5.2|2.8||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.8|-5.2|
91763450|NCT01514201|183417365|OTHER|This was descriptive in nature. Two of the first 5 patients who were escalated to 175 mg/m2 of temozolomide during the maintenance intra-patient dose escalation had dose-modifying toxicities (DMTs). Since the ad hoc stopping rule was met, intra-patient dose escalation was halted and all subsequent patients were to receive 135 mg/m2 of temozolomide during maintenance.|Percentage of patients with DMTs|40.0|||||TWO_SIDED|||||||||Intra-patient dose escalation of temozolomide during maintenance was assessed based on similar rules employed in traditional 3+3 designs. For example intra-patient dose escalation would be halted if at any time 2 out of first 2-6 patients experienced dose-modifying toxicities at a given dose level or if 4 out of first 12 patients experienced dose-modifying toxicities at a given dose level.||||
91763451|NCT00566852|183417392|SUPERIORITY_OR_OTHER|||||||0.059||||||Significance level was 0.025.|Wilcoxon (Mann-Whitney)|||Null hypothesis: patients on memantine will experience less decline than patients receiving placebo. Based on a one-sided Wilcoxon rank sum test with alpha=0.025, 221 patients per arm would be required to have 80% statistical power to detect a mean difference of 0.87 in the HVLT-R change scores between the two treatment arms. Assuming that 20% of patients may be ineligible, or die prior to the 24 week assessment, the target sample size for randomization was set to 536.||||0.059
91763452|NCT00566852|183417393|SUPERIORITY|||||||0.0692||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||8 weeks||||0.0692
91763453|NCT00566852|183417393|SUPERIORITY|||||||0.4541||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||16 weeks||||0.4541
91763454|NCT00566852|183417393|SUPERIORITY|||||||0.397||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||52 weeks||||0.3970
91538907|NCT03622580|182956088|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.1|3.3||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.3|-4.1|
91538908|NCT03622580|182956092|OTHER||Difference in CMH Weighted Percentage|-4.9|||||TWO_SIDED|95.0|-12.6|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-12.6|
91538909|NCT03622580|182956092|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-5.9|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-5.9|
91538910|NCT03622580|182956092|OTHER||Difference in CMH Weighted Percentage|-8.6|||||TWO_SIDED|95.0|-17.8|0.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.5|-17.8|
91538911|NCT03622580|182956092|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-9.9|8.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||8.2|-9.9|
91538912|NCT03622580|182956095|OTHER||Difference in CMH Weighted Percentage|-3.2|||||TWO_SIDED|95.0|-10.2|3.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||3.8|-10.2|
91763455|NCT00566852|183417394|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.01|TWO_SIDED|95.0|0.62|0.99|||Gray's test|||A one-sided log-rank test with alpha 0.025 accruing 221 patients/arm with 12 months of follow-up would ensure 98% statistical power to detect a 33% relative reduction in the monthly hazard rate with the use of memantine. Gray's test was used to test for a statistically significant difference in the distribution of neurocognitive failure times and Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||0.99|0.62|0.01
91763456|NCT00566852|183417395|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Assuming normally distributions, the two sample t-test assuming equal variances would be used to compare the arms at the 0.025 significance level. If normality assumptions were not met, the Wilcoxon rank sum would be used.||||0.77
91763457|NCT00566852|183417396|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.27|TWO_SIDED|95.0|0.87|1.3|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.3|0.87|0.27
91763458|NCT00566852|183417397|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.025|TWO_SIDED|95.0|0.86|1.31|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.31|0.86|0.025
91763459|NCT04531241|183417399|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-6.8|1.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||1.1|-6.8|
91538913|NCT03622580|182956095|OTHER||Difference in CMH Weighted Percentage|2.4|||||TWO_SIDED|95.0|-4.3|9.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.2|-4.3|
91538914|NCT03622580|182956095|OTHER||Difference in CMH Weighted Percentage|-4.7|||||TWO_SIDED|95.0|-12.6|3.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.1|-12.6|
91538915|NCT03622580|182956095|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.9|6.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||6.4|-8.9|
91538916|NCT03622580|182956098|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-1.8|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-1.8|
91538917|NCT03622580|182956098|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.3|-2.2|
91538918|NCT03622580|182956098|OTHER||Difference in CMH Weighted Percentage|0.8|||||TWO_SIDED|95.0|-2.0|3.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.6|-2.0|
91538919|NCT03622580|182956098|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.6|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-2.6|
91538920|NCT03622580|182956107|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
91538921|NCT03622580|182956107|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
91538922|NCT03622580|182956107|OTHER||Difference in CMH Weighted Percentage|-0.6|||||TWO_SIDED|95.0|-1.9|0.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.6|-1.9|
91538923|NCT03622580|182956107|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-1.5|
91538924|NCT03622580|182956108|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.2|-0.4|
91538925|NCT03622580|182956108|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
91538926|NCT03622580|182956108|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
91538927|NCT03622580|182956108|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
91538928|NCT03622580|182956115|OTHER||Adjusted mean difference|-36.2|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-47.8|-24.7||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-24.7|-47.8|
91538929|NCT03622580|182956115|OTHER||Adjusted mean difference|-26.2|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-37.7|-14.7||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.7|-37.7|
91538930|NCT03622580|182956115|OTHER||Adjusted mean difference|-31.1|STANDARD_ERROR_OF_MEAN|6.35|||TWO_SIDED|95.0|-43.6|-18.6||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-18.6|-43.6|
91538931|NCT03622580|182956115|OTHER||Adjusted mean difference|-23.9|STANDARD_ERROR_OF_MEAN|6.28|||TWO_SIDED|95.0|-36.2|-11.6||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-11.6|-36.2|
91538932|NCT03622580|182956118|OTHER||Difference in CMH Weighted Percentage|16.0|||||TWO_SIDED|95.0|8.9|23.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||23.1|8.9|
91538933|NCT03622580|182956118|OTHER||Difference in CMH Weighted Percentage|12.7|||||TWO_SIDED|95.0|5.4|20.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||20.0|5.4|
91538934|NCT03622580|182956118|OTHER||Difference in CMH Weighted Percentage|15.2|||||TWO_SIDED|95.0|7.3|23.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||23.2|7.3|
91538935|NCT03622580|182956118|OTHER||Difference in CMH Weighted Percentage|12.5|||||TWO_SIDED|95.0|4.4|20.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||20.6|4.4|
91538936|NCT03959241|182956141|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.001|TWO_SIDED|95.0|0.492|0.835||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of GRFS hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.835|0.492|0.001
91538937|NCT03959241|182956142|SUPERIORITY|||||||0.995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.995
91538938|NCT03959241|182956142|SUPERIORITY|||||||0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups||||0.001
91538939|NCT03959241|182956142|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.879|TWO_SIDED|95.0|0.758|1.267||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups using a Cox regression model for the cause-specific hazard of aGVHD||1.267|0.758|0.879
91538940|NCT03959241|182956142|SUPERIORITY||Hazard Ratio (HR)|0.386||||0.001|TWO_SIDED|95.0|0.215|0.691||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade III-IV aGVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.691|0.215|0.001
91538941|NCT03959241|182956146|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups||||0.005
91538942|NCT03959241|182956146|SUPERIORITY||Hazard Ratio (HR)|0.556||||0.002|TWO_SIDED|95.0|0.381|0.813||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||0.813|0.381|0.002
91538943|NCT03959241|182956149|SUPERIORITY|||||||0.038||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of Immunosuppression-Free Survival between the treatment groups||||0.038
91538944|NCT03959241|182956150|SUPERIORITY|||||||0.032||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Recovery between the treatment groups||||0.032
91538945|NCT03959241|182956151|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 20,000/mm\^3 between the treatment groups||||<0.001
91538946|NCT03959241|182956151|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 50,000/mm\^3 between the treatment groups||||<0.001
91538947|NCT03959241|182956152|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Lymphocyte Recovery between the treatment groups||||<0.001
91538948|NCT03959241|182956153|SUPERIORITY|||||||0.919||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 28 after transplantation between the treatment groups||||0.919
91538949|NCT03959241|182956153|SUPERIORITY|||||||0.198||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 100 after transplantation between the treatment groups||||0.198
91538950|NCT03959241|182956154|SUPERIORITY|||||||0.67||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 28 after transplantation between the treatment groups||||0.670
91538951|NCT03959241|182956154|SUPERIORITY|||||||0.607||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 100 after transplantation between the treatment groups||||0.607
91538952|NCT03959241|182956155|SUPERIORITY|||||||0.906||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease Relapse between the treatment groups||||0.906
91538953|NCT03959241|182956155|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.947|TWO_SIDED|95.0|0.641|1.515||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease Relapse hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.515|0.641|0.947
91538954|NCT03959241|182956156|SUPERIORITY|||||||0.167||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Treatment-related Mortality between the treatment groups||||0.167
91538955|NCT03959241|182956156|SUPERIORITY||Hazard Ratio (HR)|0.675||||0.133|TWO_SIDED|95.0|0.404|1.127||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Treatment-related Mortality hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.127|0.404|0.133
91538956|NCT03959241|182956160|SUPERIORITY|||||||0.018||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grade 2 and 3 infections between the treatment groups||||0.018
91538957|NCT03959241|182956161|SUPERIORITY|||||||0.825||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of CMV between the treatment groups||||0. 825
91538958|NCT03959241|182956162|SUPERIORITY|||||||0.351||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease-Free Survival between the treatment groups||||0.351
91538959|NCT03959241|182956162|SUPERIORITY||Hazard Ratio (HR)|0.847||||0.32|TWO_SIDED|95.0|0.61|1.176||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease-Free Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.176|0.610|0.320
91538960|NCT03959241|182956163|SUPERIORITY|||||||0.335||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Overall Survival between the treatment groups||||0.335
91538961|NCT03959241|182956163|SUPERIORITY||Hazard Ratio (HR)|0.797||||0.252|TWO_SIDED|95.0|0.541|1.175||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the Overall Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.175|0.541|0.252
91538962|NCT02194933|182956165|SUPERIORITY_OR_OTHER|||||||0.3992||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.3992
91538963|NCT02194933|182956166|SUPERIORITY_OR_OTHER|||||||0.0053||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.0053
91538964|NCT02194933|182956168|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Mixed Models Analysis|||||||0.1559
91538965|NCT02194933|182956168|SUPERIORITY_OR_OTHER|||||||0.6201|||||||Mixed Models Analysis|||||||0.6201
91538966|NCT02194933|182956169|SUPERIORITY_OR_OTHER|||||||0.1642|||||||Mixed Models Analysis|||||||0.1642
91538967|NCT02194933|182956169|SUPERIORITY_OR_OTHER|||||||0.1873|||||||Mixed Models Analysis|||||||0.1873
91538968|NCT02194933|182956172|SUPERIORITY_OR_OTHER|||||||0.2061|||||||Mixed Models Analysis|||||||0.2061
91538969|NCT02194933|182956172|SUPERIORITY_OR_OTHER|||||||0.1778|||||||Mixed Models Analysis|||||||0.1778
91538970|NCT02194933|182956173|SUPERIORITY_OR_OTHER|||||||0.4138|||||||Mixed Models Analysis|||||||0.4138
91538971|NCT02194933|182956173|SUPERIORITY_OR_OTHER|||||||0.3375|||||||Mixed Models Analysis|||||||0.3375
91538972|NCT02194933|182956176|SUPERIORITY_OR_OTHER|||||||0.8437|||||||Mixed Models Analysis|||||||0.8437
91538973|NCT02194933|182956176|SUPERIORITY_OR_OTHER|||||||0.8318|||||||Mixed Models Analysis|||||||0.8318
91538974|NCT02194933|182956177|SUPERIORITY_OR_OTHER|||||||0.6697|||||||Mixed Models Analysis|||||||0.6697
91538975|NCT02194933|182956177|SUPERIORITY_OR_OTHER|||||||0.8829|||||||Mixed Models Analysis|||||||0.8829
91538976|NCT02194933|182956178|SUPERIORITY_OR_OTHER|||||||0.2301|||||||Mixed Models Analysis|||||||0.2301
91538977|NCT02194933|182956178|SUPERIORITY_OR_OTHER|||||||0.0599|||||||Mixed Models Analysis|||||||0.0599
91538978|NCT02194933|182956179|SUPERIORITY_OR_OTHER|||||||0.1595|||||||Mixed Models Analysis|||||||0.1595
91538979|NCT02194933|182956179|SUPERIORITY_OR_OTHER|||||||0.1211|||||||Mixed Models Analysis|||||||0.1211
91538980|NCT02194933|182956180|SUPERIORITY_OR_OTHER|||||||0.1322|||||||Mixed Models Analysis|||||||0.1322
91538981|NCT02194933|182956180|SUPERIORITY_OR_OTHER|||||||0.2113|||||||Mixed Models Analysis|||||||0.2113
91538982|NCT02194933|182956181|SUPERIORITY_OR_OTHER|||||||0.0578|||||||Mixed Models Analysis|||||||0.0578
91538983|NCT02194933|182956181|SUPERIORITY_OR_OTHER|||||||0.0588|||||||Mixed Models Analysis|||||||0.0588
91538984|NCT02194933|182956182|SUPERIORITY_OR_OTHER|||||||0.1666|||||||Mixed Models Analysis|||||||0.1666
91538985|NCT02194933|182956182|SUPERIORITY_OR_OTHER|||||||0.767|||||||Mixed Models Analysis|||||||0.7670
91538986|NCT02194933|182956183|SUPERIORITY_OR_OTHER|||||||0.7178|||||||Mixed Models Analysis|||||||0.7178
91538987|NCT02194933|182956183|SUPERIORITY_OR_OTHER|||||||0.2336|||||||Mixed Models Analysis|||||||0.2336
91538988|NCT02194933|182956184|SUPERIORITY_OR_OTHER|||||||0.6558|||||||Mixed Models Analysis|||||||0.6558
91538989|NCT02194933|182956184|SUPERIORITY_OR_OTHER|||||||0.9058|||||||Mixed Models Analysis|||||||0.9058
91538990|NCT02194933|182956185|SUPERIORITY_OR_OTHER|||||||0.0078|||||||Mixed Models Analysis|||||||0.0078
91538991|NCT02194933|182956185|SUPERIORITY_OR_OTHER|||||||0.4272|||||||Mixed Models Analysis|||||||0.4272
91538992|NCT02336438|182956202|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.99
91538993|NCT02336438|182956203|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.4922
91538994|NCT02336438|182956204|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.77
91538995|NCT02336438|182956205|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.0156
91538996|NCT02336438|182956206|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.020
91538997|NCT02336438|182956207|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.13
91538998|NCT05190419|182956211|SUPERIORITY||Mean Difference (Net)|-35.4|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-54.7|-16.0||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-16.0|-54.7|<0.001
91538999|NCT05190419|182956211|SUPERIORITY||Mean Difference (Net)|-43.9|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-63.1|-24.8||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-24.8|-63.1|<0.001
91539000|NCT05190419|182956211|SUPERIORITY||Mean Difference (Net)|-46.4|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-65.6|-27.3||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-27.3|-65.6|<0.001
91539001|NCT02124460|182956235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.3928|TWO_SIDED|95.0|-0.08|0.03|||Linear repeated measures|Multiple imputation was used for missing follow-up data.|Health Coaching group compared to Enhanced Primary Care|||0.03|-0.08|0.3928
91539002|NCT02124460|182956236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.2306|TWO_SIDED|95.0|-0.56|2.33|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care|||2.33|-0.56|0.2306
91539003|NCT02124460|182956237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care.|||0.16|-0.02|.14
91539004|NCT02124460|182956238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.0016|TWO_SIDED|95.0|-0.81|-0.19|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||-0.19|-0.81|0.0016
91539005|NCT02124460|182956239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.22|0.62||Multiple imputation used for missing data at follow-up.|Linear repeated measures|||||0.62|0.22|<.0001
91539006|NCT02124460|182956240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.3043|TWO_SIDED|95.0|-0.16|0.53|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.53|-0.16|0.3043
91539007|NCT02124460|182956241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.0113|TWO_SIDED|95.0|0.07|0.56|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.56|0.07|0.0113
91539008|NCT02124460|182956242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.0792|TWO_SIDED|95.0|-0.45|0.03|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.03|-0.45|0.0792
91539009|NCT00392678|182956263|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91539010|NCT03008915|182956270|OTHER|Paired t-test for participants with measures on both aspirin and placebo.||||||0.692|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between measures on aspirin and placebo.||||0.692
91539011|NCT00712166|182956275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.433|TWO_SIDED|95.0|-2.83|6.44||"The primary endpoint analysis was based on a two-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeper approach was established a priori to control the type 1 error rate, however, the primary endpoint was not met."|ANCOVA|ANCOVA included: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Denominator degrees of freedom computed with Satterthwaite approximation.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~At the 5% significance level (i.e., α = 0.05) using a two-sided significance test, a sample size of 70 participants per treatment group provided at least 90% power to detect a 10 point difference between groups in the mean change from baseline at Day 28 in the CFQ-R RSS score, assuming a common standard deviation (SD) of 17.5."||6.44|-2.83|0.433
91539012|NCT00712166|182956276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.37||||0.133|TWO_SIDED|95.0|-1.04|7.78||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included terms: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 14.||7.78|-1.04|0.133
91539013|NCT00712166|182956277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965|TWO_SIDED|95.0|-4.56|4.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment, baseline CFQ-R RSS and age group (\<18 years, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 42.||4.76|-4.56|0.965
91539014|NCT00712166|182956278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47||||0.256||95.0|-1.81|6.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included: treatment, baseline CFQ-R Physical Function Domain score and age (\<18, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R physical functioning domain score at Day 28.||6.76|-1.81|0.256
91539015|NCT00712166|182956279|SUPERIORITY_OR_OTHER||||||>|0.999||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple usage was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||>0.999
91539016|NCT00712166|182956280|SUPERIORITY_OR_OTHER|||||||0.122||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple hospitalizations was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in proportion of participants hospitalized.||||0.122
91539017|NCT00712166|182956283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.016|TWO_SIDED|95.0|-2.2|-0.23||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline log10 CFU, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the log10 CFU at Day 28.||-0.23|-2.20|0.016
91539018|NCT00712166|182956284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73||||0.021|TWO_SIDED|95.0|0.42|5.04||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model includes treatment, baseline FEV1 % predicted, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in % change from baseline in FEV1 % predicted at Day 28.||5.04|0.42|0.021
91539019|NCT01264718|182956322|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|6.0|||||TWO_SIDED||||||||The estimated value is the savings per child per year insured.|||||
91539020|NCT01264718|182956322|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|4.0|||||TWO_SIDED||||||||The estimated value is the savings for each percent increase in children obtaining insurance per year.|||||
91539021|NCT03538054|182956351|SUPERIORITY||Slope|-5.065||||0.146|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.146
91539022|NCT03538054|182956352|SUPERIORITY||Slope|4.221||||0.052|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.052
91539023|NCT00667745|182956354|SUPERIORITY||F value, main effect|0.94||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
91539024|NCT00667745|182956355|SUPERIORITY||Chi-squared|0.0||||0.967|TWO_SIDED||||||Chi-squared|||||||0.967
91539025|NCT00667745|182956356|SUPERIORITY||Mean Difference (Net)|0.45||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
91539026|NCT00667745|182956357|SUPERIORITY||Mean Difference (Net)|0.02||||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
91539027|NCT00667745|182956358|SUPERIORITY||Mean Difference (Net)|0.92||||0.49|TWO_SIDED|||||Value shown above describes emergent suicidal ideation for participants with baseline MSSI = 0. P=.36 describes exacerbation of baseline suicidal ideation for those with baseline MSSI \> 0.|Mixed Models Analysis|||||||.49
91539028|NCT02317016|182956366|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% confidence intervals (CIs) for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric least-squares (LS) mean ratio|171.92|||||TWO_SIDED|90.0|145.94|202.53|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed Cmax values were compared between treatments using a mixed effects analysis of variance (ANOVA) with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both area under the plasma concentration-time curve (AUC) and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||202.53|145.94|
91539029|NCT02317016|182956367|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% CIs for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric LS Mean Ratio|134.63|||||TWO_SIDED|90.0|115.41|157.07|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed AUC values were compared between treatments using a mixed effects ANOVA with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both AUC and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||157.07|115.41|
91539030|NCT00536380|182956380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.721||95.0|||||ANCOVA|||||||0.721
91539031|NCT00387465|182956382|OTHER|The maximum tolerated dose (MTD) was derived from the number of participants experiencing dose-limiting toxicities in the Phase I arms. The MTD was the dose at which ≤30% of patients experienced DLTs during cycle 1 up to a pre-specified maximal dose of 40 mg/m2 of azacitidine.|Maximum Tolerated Dose|40.0|||||TWO_SIDED||||||||MTD of Azacitidine measured in mg/m\^2|||||
91539032|NCT03418324|182956393|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7|||||Estimated values reflects the percentage of participants with overall clinical benefit.|For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
91539033|NCT03418324|182956393|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||Estimated values reflects the percentage of participants with overall clinical benefit|For this study, we are not comparing outcome measures between the two groups.||95.7|22.3|
91539034|NCT03418324|182956396|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
91539035|NCT03418324|182956396|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7||||||For this study, we are not comparing outcome measures between the two arms.||95.7|22.3|
91539036|NCT03418324|182956397|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms.||98.7|1.3|
91539037|NCT03418324|182956397|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|11.8|88.2||||||For this study, we are not comparing outcome measures between the two arms.||88.2|11.8|
91539038|NCT01768676|182956400|NON_INFERIORITY_OR_EQUIVALENCE|The difference in percentage of subjects with a \>/= 50% reduction from baseline to Week 26 in sperm concentration between treatment arms was analyzed using Cochran-Mantel-Haenszel method to account for the randomization stratification by baseline sperm concentration. If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-12.93|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-21.56|-4.29|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||-4.29|-21.56|
91539039|NCT01768676|182956401|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-11.4|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-23.5|0.7|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0.7|-23.5|
91763460|NCT04531241|183417400|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.0199|0.0|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Low Luminance High Contrast||0.0|-0.0199|
91539040|NCT01768676|182956402|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-1.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-4.2|1.3|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.3|-4.2|
91539041|NCT01768676|182956403|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-2.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-6.8|1.1|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.1|-6.8|
91539042|NCT01768676|182956404|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|95.0|0.0|0.0|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0|0|
91539043|NCT00605033|182956405|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.|Proportion difference|-0.054|||||TWO_SIDED|95.0|-0.142|0.034|||Binomial approximation|||||0.034|-0.142|
91539044|NCT02023125|182956415|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|270.0|||||TWO_SIDED|90.0|228.0|320.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).||320|228|
91539045|NCT02023125|182956416|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|116.0|||||TWO_SIDED|90.0|103.0|132.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||132|103|
91539046|NCT02023125|182956417|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|292.0|||||TWO_SIDED|90.0|258.0|329.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||329|258|
91763461|NCT04531241|183417400|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.0066|||TWO_SIDED|95.0|-0.0173|0.0087|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|High Luminance Low Contrast||0.0087|-0.0173|
91539047|NCT02023125|182956418|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|109.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|109|
91539048|NCT02023125|182956419|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|377.0|||||TWO_SIDED|90.0|303.0|468.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||468|303|
91539049|NCT02023125|182956420|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|102.0|||||TWO_SIDED|90.0|87.0|119.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||119|87.0|
91539050|NCT02023125|182956421|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|328.0|||||TWO_SIDED|90.0|276.0|389.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||389|276|
91539051|NCT02023125|182956422|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|110.0|||||TWO_SIDED|90.0|96.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|96.3|
91539052|NCT02023125|182956425|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|306.0|||||TWO_SIDED|90.0|269.0|348.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||348|269|
91539053|NCT02023125|182956426|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|110.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|110|
91539054|NCT02023125|182956427|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|349.0|||||TWO_SIDED|90.0|288.0|422.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||422|288|
91539055|NCT02023125|182956428|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|109.0|||||TWO_SIDED|90.0|95.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|95.3|
91539056|NCT04493242|182956488|OTHER|log-rank test||||||0.1343|||||||Chi-squared|||||||0.1343
91539057|NCT01124188|182956511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.63|1.8||||||||1.80|0.63|
91539058|NCT01124188|182956512|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mixed Models Analysis|||||||.49
91763462|NCT04531241|183417401|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 1 hour difference in average daily wear time at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 1 hour was used.|Least-Square Mean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.0731|||TWO_SIDED|95.0|-0.1968|0.0933|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.0933|-0.1968|
91539059|NCT01124188|182956513|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
91539060|NCT02027558|182956534|SUPERIORITY||Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.58|-1.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-1.83|-4.58|<.001
91539061|NCT02027558|182956535|SUPERIORITY||Mean Difference (Net)|-16.23|STANDARD_ERROR_OF_MEAN|6.52||0.013|TWO_SIDED|95.0|-29.02|-2.49|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-2.49|-29.02|0.013
91539062|NCT02027558|182956536|SUPERIORITY||Mean Difference (Net)|-20.46|STANDARD_ERROR_OF_MEAN|8.75||0.019|TWO_SIDED|95.0|-37.63|-3.29|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-3.29|-37.63|0.019
91539063|NCT02027558|182956537|SUPERIORITY||Mean Difference (Net)|10.49|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|4.53|16.44|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||16.44|4.53|0.001
91539064|NCT02027558|182956538|SUPERIORITY||Mean Difference (Net)|4.35|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|1.87|6.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||6.83|1.87|0.001
91539065|NCT02027558|182956539|SUPERIORITY||Mean Difference (Final Values)|-17.42|STANDARD_ERROR_OF_MEAN|4.99||0.0007|TWO_SIDED|95.0|-27.29|-7.55|||t-test, 2 sided|||||-7.55|-27.29|0.0007
91539066|NCT00516386|182956540|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|543.0|STANDARD_ERROR_OF_MEAN|41.0|<|0.05|||||||Paired t-test|||We used paired t-tests to assess changes in levels of IGF-1 from baseline levels in girls with AN receiving rhIGF-1. Our hypothesis was that rhIGF-1 administration would be associated with a significant increase in IGF-1 levels.||||<0.05
91539067|NCT00516386|182956541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.3|STANDARD_ERROR_OF_MEAN|9.3|<|0.05||95.0|||||Paired t-test|||We used a paired t-test to determine the change in P1NP from baseline to 7-10 days following administration of rhIGF-1||||<0.05
91539068|NCT02694978|182956559|NON_INFERIORITY|The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.|Treatment difference|-0.1||||0.0001|TWO_SIDED|95.0|-0.8|0.61|||Wald|The p-value was calculated using the Wald large sample assumption.||"Statistical analysis was only performed on composite reaction data (that is, the Any TE moderate to severe hypersensitivity rxn row in the data table)."||0.61|-0.80|0.0001
91539069|NCT03675581|182956577|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.36|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|92.83|110.67|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||110.67|92.83|
91539070|NCT03675581|182956578|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|96.4|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|91.48|101.58|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T = Test, R = Reference|||101.58|91.48|
91539071|NCT03675581|182956579|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|116.69|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|107.63|126.51|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||126.51|107.63|
91539072|NCT03675581|182956580|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|100.89|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|89.9|113.23|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||113.23|89.90|
91539073|NCT03675581|182956581|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.24|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|93.95|109.1|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||109.10|93.95|
91539074|NCT03675581|182956582|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|88.09|STANDARD_DEVIATION|15.0|||TWO_SIDED|90.0|80.03|96.96|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||96.96|80.03|
91539075|NCT00186186|182956583|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
91539076|NCT00186186|182956584|SUPERIORITY_OR_OTHER||Percentage|54.0|||||TWO_SIDED|||||||||||||
91539077|NCT00807144|182956587|SUPERIORITY|||||||0.26|||||||Log Rank|||||||0.26
91539078|NCT00807144|182956588|SUPERIORITY|||||||0.48|||||||Log Rank|||Year 1||||0.48
91539079|NCT00807144|182956588|SUPERIORITY|||||||0.75|||||||Log Rank|||Year 2||||0.75
91539080|NCT01616654|182956606|SUPERIORITY||Percentage difference|13.115||||0.096|TWO_SIDED|95.0|-3.266|29.495|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||29.495|-3.266|0.096
91539081|NCT01616654|182956606|SUPERIORITY||Percentage difference|16.393||||0.04|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction||33.036|-0.249|0.040
91539082|NCT01616654|182956606|SUPERIORITY||Percentage difference|10.273||||0.184|TWO_SIDED|95.0|-5.923|26.47|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||26.470|-5.923|0.184
91539083|NCT01616654|182956606|SUPERIORITY||Percentage difference|16.393||||0.041|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||33.036|-0.249|0.041
91539084|NCT01616654|182956607|SUPERIORITY||Percentage difference|-6.74||||0.108|TWO_SIDED|95.0|-14.96|1.48|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||1.48|-14.96|0.108
91539085|NCT01616654|182956607|SUPERIORITY||Percentage difference|-7.88||||0.06|TWO_SIDED|95.0|-16.11|0.34|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||0.34|-16.11|0.060
91539086|NCT01616654|182956607|SUPERIORITY||Percentage difference|-8.11||||0.054|TWO_SIDED|95.0|-16.35|0.13|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||0.13|-16.35|0.054
91539087|NCT01616654|182956607|SUPERIORITY||Percentage difference|-12.97||||0.002|TWO_SIDED|95.0|-21.18|-4.76|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||-4.76|-21.18|0.002
91539088|NCT01616654|182956608|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|||||||0.067
91539089|NCT01616654|182956608|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||||||0.054
91539090|NCT01616654|182956608|SUPERIORITY|||||||0.038|||||||Cochran-Mantel-Haenszel|||||||0.038
91539091|NCT01616654|182956608|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
91539092|NCT02057692|182956612|SUPERIORITY||LS mean difference|-0.889|STANDARD_ERROR_OF_MEAN|0.3969||0.0321|TWO_SIDED|95.0|-1.698|0.081|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by analysis of covariance (ANCOVA) using a PROC MIXED procedure. Least-squares (LS) mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.081|-1.698|0.0321
91539093|NCT02057692|182956612|SUPERIORITY||LS mean difference|-0.906|STANDARD_ERROR_OF_MEAN|0.3503||0.0145|TWO_SIDED|95.0|-1.62|-0.192|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% CI for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||-0.192|-1.620|0.0145
91539094|NCT02057692|182956612|SUPERIORITY||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.4431||0.9298|TWO_SIDED|95.0|-0.942|0.863|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.863|-0.942|0.9298
91539095|NCT03923491|182956617|SUPERIORITY||Slope|-0.55|STANDARD_ERROR_OF_MEAN|4.69||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total score controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539096|NCT03923491|182956617|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.49||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total vegetable component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539097|NCT03923491|182956617|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 greens and beans component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
91539098|NCT03923491|182956617|SUPERIORITY||Slope|1.71|STANDARD_ERROR_OF_MEAN|0.67||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
91539099|NCT03923491|182956617|SUPERIORITY||Slope|2.14|STANDARD_ERROR_OF_MEAN|0.83||0.19|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.19
91539100|NCT03923491|182956617|SUPERIORITY||Slope|0.83|STANDARD_ERROR_OF_MEAN|1.1||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole grain component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
91539101|NCT03923491|182956617|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total dairy component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
91539102|NCT03923491|182956617|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.42||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total protein foods component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539103|NCT03923491|182956617|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.85||-0.12|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 seafood and plant protein component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||-0.12
91539104|NCT03923491|182956617|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|1.12||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 fatty acid component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539105|NCT03923491|182956617|SUPERIORITY||Slope|-2.09|STANDARD_ERROR_OF_MEAN|0.97||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 sodium component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539106|NCT03923491|182956617|SUPERIORITY||Slope|-0.8|STANDARD_ERROR_OF_MEAN|1.16||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 refined grains component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539107|NCT03923491|182956617|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|1.13||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 added sugar component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
91539108|NCT03923491|182956617|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.86||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||||||1.00
91539109|NCT00355914|182956620|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||compared baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
91763463|NCT04531241|183417402|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-5.5|0.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.3|-5.5|
91539110|NCT00355914|182956621|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
91539111|NCT02633358|182956622|SUPERIORITY|Therapeutic hypothermia need to have superiority in the survival rate after 90 days|Risk Ratio (RR)|0.58|||<|0.001|TWO_SIDED|95.0|0.41|0.82||P-value less than 0.05 means significant data|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.82|0.41|<0.001
91539112|NCT02633358|182956623|SUPERIORITY|Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.|Risk Ratio (RR)|0.8||||0.04|TWO_SIDED|95.0|0.66|0.98||P value less than 0.05 means significant date|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.98|0.66|0.04
91539113|NCT02633358|182956624|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
91539114|NCT02633358|182956625|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
91539115|NCT02633358|182956626|SUPERIORITY||||||<|0.05||||||P-value less then 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
91539116|NCT03823300|182956627|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.7|1.8|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||1.8|-1.7|
91539117|NCT03823300|182956628|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.4|1.3|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||1.3|-2.4|
91539118|NCT03823300|182956630|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.3|4.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||4.3|-8.3|
91539119|NCT03823300|182956630|OTHER||Difference in CMH Weighted Percentage|3.4|||||TWO_SIDED|95.0|-3.9|10.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||10.7|-3.9|
91539120|NCT03823300|182956630|OTHER||Difference in CMH Weighted Percentage|1.0|||||TWO_SIDED|95.0|-6.6|8.6|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.6|-6.6|
91539121|NCT03823300|182956630|OTHER||Difference in CMH Weighted Percentage|3.1|||||TWO_SIDED|95.0|-3.1|9.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||9.3|-3.1|
91763464|NCT01702246|183417421|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||Wilcoxon matched pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.005
91539122|NCT03823300|182956631|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.7|5.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||5.3|-7.7|
91539123|NCT03823300|182956636|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-4.4|1.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||1.3|-4.4|
91539124|NCT03823300|182956636|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-4.5|2.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||2.8|-4.5|
91539125|NCT03823300|182956636|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-2.1|7.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||7.3|-2.1|
91763465|NCT01702246|183417422|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
91763466|NCT01702246|183417423|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91763467|NCT04209205|183417446|SUPERIORITY||Marginal difference|25.02|||<|0.0001|TWO_SIDED|95.0|17.61|32.43|||Regression, Logistic|||||32.43|17.61|<.0001
91763468|NCT04209205|183417447|SUPERIORITY||Marginal difference|30.59|||<|0.0001|TWO_SIDED|95.0|21.14|40.05|||Regression, Logistic|||||40.05|21.14|<.0001
91763469|NCT04209205|183417448|SUPERIORITY||Marginal difference|17.17|||<|0.0001|TWO_SIDED|95.0|10.48|23.85|||Regression, Logistic|||||23.85|10.48|<.0001
91763470|NCT04209205|183417449|SUPERIORITY||Marginal difference|41.39|||<|0.0001|TWO_SIDED|95.0|30.64|52.13|||Regression, Logistic|||||52.13|30.64|<.0001
91763471|NCT04209205|183417450|SUPERIORITY||Least squares mean|-1.13|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.38|0.87|||Mixed Models Analysis|||||0.87|-1.38|<.0001
91763472|NCT04209205|183417451|SUPERIORITY||Least squares mean|-0.24|STANDARD_ERROR_OF_MEAN|-0.043|<|0.0001|TWO_SIDED|95.0|-0.32|0.15|||Mixed Models Analysis|||||0.15|-0.32|<.0001
91763473|NCT04209205|183417452|SUPERIORITY||Least squares mean|4.13|STANDARD_ERROR_OF_MEAN|0.676|<|0.0001|TWO_SIDED|95.0|2.8|5.46|||Mixed Models Analysis|||||5.46|2.80|<.0001
91763474|NCT04209205|183417453|SUPERIORITY||Least squares mean|2.85|STANDARD_ERROR_OF_MEAN|0.933||0.0024|TWO_SIDED|95.0|1.01|4.68|||Mixed Models Analysis|||||4.68|1.01|0.0024
91763475|NCT04209205|183417454|SUPERIORITY||Least squares mean|-6.11|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.96|-3.26|||Mixed Models Analysis|||||-3.26|-8.96|<.0001
91539126|NCT03823300|182956637|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.3|-2.6|
91539127|NCT03823300|182956641|OTHER||Difference in CMH Weighted Percentage|-1.7|||||TWO_SIDED|95.0|-8.5|5.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||5.1|-8.5|
91539128|NCT03823300|182956643|OTHER||Difference in CMH Weighted Percentage|5.7|||||TWO_SIDED|95.0|-1.4|12.9|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||12.9|-1.4|
91539129|NCT03823300|182956645|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-3.6|4.4|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||4.4|-3.6|
91539130|NCT03823300|182956653|OTHER||Adjusted mean difference|-6.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.8|2.1|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||2.1|-14.8|
91539131|NCT03823300|182956654|OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|4.05|||TWO_SIDED|95.0|-6.6|9.3|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.3|-6.6|
91539132|NCT01290224|182956674|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided McNemar's test of the primary endpoint with 10 patients will have 86% power at 5% Type I error rate to detect a 60% difference in the percentage of at least 50% reduction in the scrambler and sham procedure, based on the assumption that the proportion of discordant pairs is at 70%.||||||0.763||95.0|||||McNemar|||McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.||||0.7630
91539133|NCT02311972|182956691|SUPERIORITY|Mean axillary admission temperature||||||0.7294|||||||t-test, 2 sided|||||||0.7294
91539134|NCT02311972|182956692|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.2360
91539135|NCT02311972|182956693|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91539136|NCT02311972|182956694|SUPERIORITY|||||||0.1089|||||||t-test, 2 sided|||||||0.1089
91539137|NCT02311972|182956695|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91763476|NCT04209205|183417455|SUPERIORITY||Marginal difference|27.49||||0.0003|TWO_SIDED|95.0|12.43|42.55|||Regression, Logistic|||||42.55|12.43|0.0003
91539138|NCT02311972|182956696|SUPERIORITY|||||||0.4947|||||||t-test, 2 sided|||||||0.4947
91539139|NCT02311972|182956697|SUPERIORITY|Infant 007|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91539140|NCT02311972|182956697|SUPERIORITY|Infant 010|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91539141|NCT02311972|182956697|SUPERIORITY|Infant 015|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91539142|NCT02311972|182956697|SUPERIORITY|Infant 039|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91539143|NCT02311972|182956697|SUPERIORITY|Infant 040||||||0.3947|||||||t-test, 2 sided|||||||0.3947
91539144|NCT02393716|182956705|OTHER|Single arm study with a hypothesis test comparing to performance goal|Percentage|2.9|||<|0.001|ONE_SIDED|97.5||7.2|||Based on exact binomial distribution|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a MAE within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 20% is the safety PG."||7.2||<0.001
91539145|NCT02393716|182956706|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|95.8|||<|0.001|ONE_SIDED|97.5|90.4||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||90.4|<0.001
91539146|NCT01924767|182956724|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|43.661|||||TWO_SIDED|95.0|27.52|69.269|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.||69.269|27.520|
91763477|NCT04209205|183417456|SUPERIORITY||Marginal difference|16.35||||0.0102|TWO_SIDED|95.0|3.88|28.82|||Regression, Logistic|||||28.82|3.88|0.0102
91763478|NCT00999544|183417466|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Area-under-the-curve (AUC) scores were derived from time course data and analyzed using two-factor ANOVA \[aprepitant dose (3 levels)x oxycodone dose (3 levels)\].~All analyses were conducted using SAS 9.1 for Windows (SAS Institute Inc., Cary, NC, USA) and were considered significant when P 0.05."||||<.05
91539147|NCT01924767|182956724|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|31.234|||||TWO_SIDED|95.0|12.193|80.011|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.||80.011|12.193|
91539148|NCT01924767|182956725|SUPERIORITY_OR_OTHER||Geometric mean of ratio|49.707|||||TWO_SIDED|95.0|33.49|73.776|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.||73.776|33.490|
91539149|NCT01924767|182956725|SUPERIORITY_OR_OTHER||Geometric mean of ratio|37.632|||||TWO_SIDED|95.0|15.429|91.789|||Regression, Linear|||This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.||91.789|15.429|
91539150|NCT01924767|182956736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37645.43||||0.0067|TWO_SIDED|95.0|11021.57|64269.3||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.||The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||64269.30|11021.57|0.0067
91763479|NCT02178995|183417495|SUPERIORITY_OR_OTHER|||||||0.037||||||HRTSD p-value = 0.037; p \< 0.05 considered significant|ANOVA|Within-subjects contrasts, n=31, df=1||||||0.037
91539151|NCT01924767|182956736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82898.2|||<|0.0001|TWO_SIDED|95.0|55344.83|110451.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||110451.6|55344.83|<0.0001
91539152|NCT01924767|182956736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79982.89|||<|0.0001|TWO_SIDED|95.0|53087.22|106878.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||106878.6|53087.22|<0.0001
91539153|NCT01924767|182956736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|91306.96|||<|0.0001|TWO_SIDED|95.0|64685.41|117928.5||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo was calculated|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||117928.5|64685.41|<0.0001
91539154|NCT01924767|182956737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.456||||0.0449|TWO_SIDED|95.0|-30.543|-0.369||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.369|-30.543|0.0449
91539155|NCT01924767|182956737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.467||||0.0042|TWO_SIDED|95.0|-39.085|-7.848||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-7.848|-39.085|0.0042
91539156|NCT01924767|182956737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.956||||0.0521|TWO_SIDED|95.0|-30.057|0.145||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||0.145|-30.057|0.0521
91539157|NCT01924767|182956737|SUPERIORITY_OR_OTHER||Difference to placebo|-10.602||||0.1676|TWO_SIDED|95.0|-25.848|4.644||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.644|-25.848|0.1676
91539158|NCT01924767|182956738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.269||||0.2239|TWO_SIDED|95.0|-19.162|4.624||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.624|-19.162|0.2239
91539159|NCT01924767|182956738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.844||||0.0421||95.0|-25.205|-0.484||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.484|-25.205|0.0421
91539160|NCT01924767|182956738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.719||||0.6527|TWO_SIDED|95.0|-14.842|9.403||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||9.403|-14.842|0.6527
91539161|NCT01924767|182956738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.998||||0.1318|TWO_SIDED|95.0|-20.818|2.822||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||2.822|-20.818|0.1318
91539162|NCT00470106|182956801|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Not corrected for multiple comparisons because it is primary.|mixed model|same analysis as for secondary outcome variable.||||||<.001
91539163|NCT00470106|182956802|SUPERIORITY_OR_OTHER||||||<|0.1||||||A priori threshold for significance was P \< .05|mixed model|Same as for the primary variable.||||||<.10
91539164|NCT03621761|182956805|SUPERIORITY||Slope|1.774||||0.3451|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.3451
91539165|NCT03621761|182956805|SUPERIORITY||Slope|1.3094||||0.4834|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.4834
91539166|NCT03621761|182956806|SUPERIORITY||Slope|0.4077||||0.257|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.2570
91539167|NCT03621761|182956806|SUPERIORITY||Slope|-0.2452||||0.5017|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.5017
91763480|NCT02178995|183417495|SUPERIORITY_OR_OTHER|||||||0.055||||||D' p = 0.055. p \< 0.05 considered significant.|ANOVA|Within-subjects contrasts, placebo v 10mg v 20mg.||||||0.055
91763481|NCT02178995|183417495|SUPERIORITY_OR_OTHER|||||||0.758|||||||t-test, 2 sided|||HRTSD 10mg vs 20mg||||0.758
91763482|NCT02178995|183417495|SUPERIORITY_OR_OTHER|||||||0.499|||||||t-test, 2 sided|||d' 10mg vs 20mg||||0.499
91763483|NCT02178995|183417496|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA|||||||0.008
91763484|NCT02178995|183417496|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||SDMT 10mg vs 20mg||||0.071
91763485|NCT02178995|183417497|SUPERIORITY_OR_OTHER|||||||0.154|||||||ANOVA|||||||0.154
91763486|NCT02178995|183417497|SUPERIORITY_OR_OTHER|||||||0.779|||||||t-test, 2 sided|||MCG 10mg vs 20mg||||0.779
91763487|NCT02178995|183417498|SUPERIORITY_OR_OTHER||||||<|0.0001||||||HRTSD P\<0.0001|t-test, 2 sided|||Intra-group comparison, HRTSD||||<0.0001
91539168|NCT03621761|182956807|SUPERIORITY||Slope|0.095||||0.154|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.154
91539169|NCT03621761|182956807|SUPERIORITY||Slope|0.034||||0.61|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.610
91539170|NCT03621761|182956808|SUPERIORITY||Slope|0.00427||||0.4955|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.4955
91539171|NCT03621761|182956808|SUPERIORITY||Slope|-0.00948||||0.1333|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.1333
91539172|NCT03987451|182956824|SUPERIORITY||Odds Ratio (OR)|0.28||||0.0867|TWO_SIDED|95.0|0.06|1.24|||Cochran-Mantel-Haenszel|||The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.||1.24|0.06|0.0867
91539173|NCT01183780|182956876|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0219|TWO_SIDED|95.0|0.73|0.976|||Log Rank|The analysis was performed on stratified data.|The estimation was performed on stratified data.|||0.976|0.730|0.0219
91539174|NCT01183780|182956877|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.793||||0.0005|TWO_SIDED|95.0|0.697|0.903|||Log Rank|Analysis was performed on stratified data.|Analysis was performed on stratified data.|||0.903|0.697|0.0005
91539175|NCT01183780|182956878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6336|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6336
91539176|NCT04246762|182956932|OTHER||geometric LS mean ratio of AUC (0-inf))|70.46|||||TWO_SIDED|90.0|60.62|81.91|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.91|60.62|
91539177|NCT04246762|182956932|OTHER||geometric LS mean ratio of AUC (0-inf))|67.87|||||TWO_SIDED|90.0|56.73|81.21|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.21|56.73|
91539178|NCT04246762|182956932|OTHER||geometric LS mean ratio of AUC (0-inf))|122.92|||||TWO_SIDED|90.0|107.98|139.93|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||139.93|107.98|
91539179|NCT04246762|182956933|OTHER||geometric LS mean ratio of AUC (0-last))|90.83|||||TWO_SIDED|90.0|86.72|95.13|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI.||95.13|86.72|
91539180|NCT04246762|182956934|OTHER||geometric LS mean ratio of Cmax|68.5|||||TWO_SIDED|90.0|59.46|78.92|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||78.92|59.46|
91539181|NCT04246762|182956934|OTHER||geometric LS mean ratio of Cmax|73.54|||||TWO_SIDED|90.0|64.18|84.27|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||84.27|64.18|
91539182|NCT04246762|182956934|OTHER||geometric LS mean ratio of Cmax|97.99|||||TWO_SIDED|90.0|91.36|105.09|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||105.09|91.36|
91539183|NCT04246762|182956934|OTHER||geometric LS mean ratio of Cmax|102.3|||||TWO_SIDED|90.0|94.8|110.39|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI. The sample size computation was based on results reported for sirukumab.||110.39|94.80|
91539184|NCT02878330|182956945|SUPERIORITY||Relative Risk Reduction|70.1|||<|0.0001|TWO_SIDED|95.0|52.3|81.2|||Poisson regression|||||81.2|52.3|<0.0001
91539185|NCT02878330|182956946|SUPERIORITY||Relative Risk Reduction|78.4||||0.0002|TWO_SIDED|95.0|51.9|90.3|||Poisson regression|||||90.3|51.9|0.0002
91539186|NCT03615924|182956952|SUPERIORITY||Incidence rate ratio|1.06||||0.7597|TWO_SIDED|95.0|0.75|1.5|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.50|0.75|0.7597
91539187|NCT03615924|182956953|SUPERIORITY||Incidence rate ratio|1.02||||0.9037|TWO_SIDED|95.0|0.72|1.45|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.45|0.72|0.9037
91539188|NCT03615924|182956954|SUPERIORITY||Incidence rate ratio|0.76||||0.7136|TWO_SIDED|95.0|0.17|3.3|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.30|0.17|0.7136
91539189|NCT03615924|182956955|SUPERIORITY||Incidence rate ratio|0.84||||0.497|TWO_SIDED|95.0|0.5|1.4|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.40|0.50|0.4970
91539190|NCT03615924|182956956|SUPERIORITY||Incidence rate ratio|1.43||||0.1636|TWO_SIDED|95.0|0.87|2.36|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||2.36|0.87|0.1636
91539191|NCT03615924|182956957|SUPERIORITY||Incidence rate ratio|1.68||||0.2011|TWO_SIDED|95.0|0.76|3.75|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.75|0.76|0.2011
91539192|NCT03615924|182956959|SUPERIORITY||Incidence rate ratio|0.0||||0.994|TWO_SIDED|95.0|0.0||Upper limit of confidence interval was not calculable due to 0 events in Ticagrelor 15/30/45 mg bd reporting group.||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.|||0.00|0.9940
91539193|NCT03615924|182956960|SUPERIORITY||Incidence rate ratio|0.77||||0.4822|TWO_SIDED|95.0|0.38|1.58|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.58|0.38|0.4822
91539194|NCT02954848|182956974|SUPERIORITY||Median Difference (Final Values)|3.8||||0.0643|TWO_SIDED|95.0|0.0|10.6|||Wilcoxon Rank-Sum Test||The point estimate of the median difference between the treatment groups was calculated using the Hodges-Lehmann estimation.|||10.600|0.000|0.0643
91539195|NCT02954848|182956975|SUPERIORITY|||||||0.0003|||||||Log Rank|||||||0.0003
91539196|NCT02954848|182956976|SUPERIORITY||Median Difference (Final Values)|-0.11||||0.0826|TWO_SIDED|95.0|-0.24|0.01|||Wilcoxon Rank-Sum Test|||||0.0100|-0.2400|0.0826
91539197|NCT02954848|182956977|SUPERIORITY||Median Difference (Final Values)|3.3||||0.0478|TWO_SIDED|95.0|0.0|5.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||5.300|0.000|0.0478
91539198|NCT02954848|182956977|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8963|TWO_SIDED|95.0|-6.1|6.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||6.000|-6.100|0.8963
91539199|NCT02954848|182956977|SUPERIORITY||Median Difference (Final Values)|5.2||||0.012|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||10.700|0.000|0.0120
91539200|NCT02954848|182956977|SUPERIORITY||Median Difference (Final Values)|-4.7||||0.0871|TWO_SIDED|95.0|-17.4|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.000|-17.400|0.0871
91539201|NCT02954848|182956978|SUPERIORITY|||||||0.0025|||||||Log Rank|||||||0.0025
91539202|NCT02954848|182956979|SUPERIORITY|||||||0.1059|||||||Log Rank|||||||0.1059
91539203|NCT02954848|182956980|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
91539204|NCT02954848|182956981|SUPERIORITY|||||||0.5393|||||||Log Rank|||||||0.5393
91539205|NCT02954848|182956982|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.0505|TWO_SIDED|95.0|-0.21|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||0.0000|-0.2100|0.0505
91539206|NCT02954848|182956982|SUPERIORITY||Median Difference (Final Values)|0.02||||0.8138|TWO_SIDED|95.0|-0.12|0.15|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||0.1500|-0.1200|0.8138
91539207|NCT02954848|182956982|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.0129|TWO_SIDED|95.0|-0.28|-0.03|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||-0.0300|-0.2800|0.0129
91539208|NCT02954848|182956982|SUPERIORITY||Median Difference (Final Values)|0.17||||0.0765|TWO_SIDED|95.0|-0.01|0.36|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.3600|-0.0100|0.0765
91539209|NCT02954848|182956983|SUPERIORITY||Median Difference (Final Values)|6.5||||0.149|TWO_SIDED|95.0|-1.9|15.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||15.300|-1.900|0.1490
91517851|NCT00677833|182910157|SUPERIORITY_OR_OTHER||ACPR percent difference|-13.07|||||TWO_SIDED|95.0|-24.21|-1.92|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-1.92|-24.21|
91517852|NCT00677833|182910157|SUPERIORITY_OR_OTHER||ACPR percent difference|-19.62|||||TWO_SIDED|95.0|-32.16|-7.08|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-7.08|-32.16|
91517853|NCT00677833|182910157|SUPERIORITY_OR_OTHER||ACPR percent difference|-16.38|||||TWO_SIDED|95.0|-29.42|-3.33|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-3.33|-29.42|
91517854|NCT00677833|182910157|SUPERIORITY_OR_OTHER||ACPR Percent difference|-16.94|||||TWO_SIDED|95.0|-30.04|-3.83|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)- (AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.||-3.83|-30.04|
91517855|NCT00677833|182910164|SUPERIORITY_OR_OTHER||percent difference|-5.89|||||TWO_SIDED|95.0|-11.02|-0.75|||large sample approximation to binomial|||Day 7||-0.75|-11.02|
91517856|NCT00677833|182910164|SUPERIORITY_OR_OTHER||percent difference|-7.55|||||TWO_SIDED|95.0|-13.14|-1.95|||large sample approximation to binomial|||Day 14||-1.95|-13.14|
91517857|NCT00677833|182910164|SUPERIORITY_OR_OTHER||percent difference|-7.6|||||TWO_SIDED|95.0|-13.61|-1.6|||large sample approximation to binomial|||Day 21||-1.60|-13.61|
91517858|NCT00677833|182910164|SUPERIORITY_OR_OTHER||percent difference|-9.26|||||TWO_SIDED|95.0|-15.64|-2.87|||Large sample approximation to binomial|||Day 28||-2.87|-15.64|
91517859|NCT00677833|182910164|SUPERIORITY_OR_OTHER||percent difference|-7.71|||||TWO_SIDED|95.0|-14.45|-0.97|||Large sample approximation to binomial|||Day 35||-0.97|-14.45|
91517860|NCT00677833|182910164|SUPERIORITY_OR_OTHER||percent difference|-8.52|||||TWO_SIDED|95.0|-15.43|-1.6|||Large sample approximation to binomial|||Day 42||-1.60|-15.43|
91517861|NCT00677833|182910165|SUPERIORITY_OR_OTHER||percent difference|-9.51|||||TWO_SIDED|95.0|-18.27|-0.74|||Large sample approximation to binomial|||Day 7||-0.74|-18.27|
91517862|NCT00677833|182910165|SUPERIORITY_OR_OTHER||percent difference|-10.39|||||TWO_SIDED|95.0|-19.23|-1.55|||Large sample approximation to binomial|||Day 14||-1.55|-19.23|
91517863|NCT00677833|182910165|SUPERIORITY_OR_OTHER||percent difference|-12.75|||||TWO_SIDED|95.0|-21.45|-4.04|||Large sample approximation to binomial|||Day 21||-4.04|-21.45|
91517864|NCT00677833|182910165|SUPERIORITY_OR_OTHER||percent difference|-11.11|||||TWO_SIDED|95.0|-19.62|-2.6|||Large sample approximation to binomial|||Day 28||-2.60|-19.62|
91517865|NCT00677833|182910165|SUPERIORITY_OR_OTHER||percent difference|-10.34|||||TWO_SIDED|95.0|-18.97|-1.71|||Large sample approximation to binomial|||Day 35||-1.71|-18.97|
91517866|NCT00677833|182910165|SUPERIORITY_OR_OTHER||percent difference|-11.21|||||TWO_SIDED|95.0|-20.14|-2.28|||Large sample approximation to binomial|||Day 42||-2.28|-20.14|
91517867|NCT00677833|182910166|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.2564
91517868|NCT00677833|182910167|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||<0.0001
91517869|NCT00677833|182910170|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.0006
91517870|NCT02184611|182910177|OTHER||Least square mean difference|0.154|||<|0.001|TWO_SIDED|95.0|0.113|0.194||Analysis was performed using a MMRM model with covariates of treatment, Baseline, smoking status, country, Day, Day by Baseline and Day by treatment interactions.|Mixed Models Repeated Measures (MMRM)|||UMEC versus Placebo.||0.194|0.113|<0.001
91517871|NCT02184611|182910178|OTHER||Least square Mean difference|0.9||||0.004|TWO_SIDED|95.0|0.3|1.5||Analysis performed using a MMRM model with covariates of treatment, BDI focal score, smoking status, country, Day, Day by BDI focal score and Day by treatment interactions.|MMRM|||UMEC versus Placebo.||1.5|0.3|0.004
91517872|NCT02184611|182910179|OTHER||Least square Mean difference|0.125|||<|0.001|TWO_SIDED|95.0|0.103|0.147||Analysis performed using an analysis of covariance (ANCOVA) model with covariates of treatment, baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status and country.|ANCOVA|||UMEC versus Placebo.||0.147|0.103|<0.001
91517873|NCT02184611|182910188|OTHER||Least sqaure mean difference|-4.39||||0.002|TWO_SIDED|95.0|-7.21|-1.58||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-1.58|-7.21|0.002
91517874|NCT02184611|182910188|OTHER||Least square mean difference|-4.59||||0.003|TWO_SIDED|95.0|-7.61|-1.57||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-1.57|-7.61|0.003
91517875|NCT02184611|182910188|OTHER||Least sqaure mean difference|-3.03||||0.058|TWO_SIDED|95.0|-6.15|0.1||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 168, UMEC Vs Placebo.||0.10|-6.15|0.058
91517876|NCT02184611|182910189|OTHER||Least sqaure mean difference|-1.49||||0.027|TWO_SIDED|95.0|-2.81|-0.17||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-0.17|-2.81|0.027
91763488|NCT02178995|183417498|SUPERIORITY_OR_OTHER|||||||0.001||||||HRTSD p \<0.001 for healthy controls|t-test, 2 sided|||Intra-group comparison, HRTSD, healthy controls||||0.001
91763489|NCT02178995|183417498|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Between-group comparisons by 2-way ANOVA, HRTSD||||0.322
91763490|NCT02178995|183417498|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Intra-group comparison, epilepsy, D'||||<0.0001
91763491|NCT02178995|183417498|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||Intra-group analysis, healthy controls, d'||||0.037
91763492|NCT02178995|183417498|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Intra-group analysis by 2-way ANOVA, d'||||0.08
91763493|NCT02178995|183417499|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91763494|NCT02178995|183417499|SUPERIORITY_OR_OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
91763495|NCT02178995|183417499|SUPERIORITY_OR_OTHER|||||||0.443|||||||ANOVA|||Group x time interaction by 2-way ANOVA||||0.443
91763496|NCT02178995|183417500|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91763497|NCT02178995|183417500|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
91763498|NCT02178995|183417500|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANOVA|||Between-groups analysis by 2-way ANOVA||||0.906
91763499|NCT02178995|183417501|SUPERIORITY_OR_OTHER|||||||0.274|||||||t-test, 2 sided|||||||0.274
91763500|NCT02178995|183417502|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91763501|NCT02178995|183417503|SUPERIORITY_OR_OTHER|||||||0.04||||||Hits p = 0.04|ANOVA|||||||0.04
91517877|NCT02184611|182910189|OTHER||Least square mean difference|-2.1||||0.004|TWO_SIDED|95.0|-3.51|-0.68||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-0.68|-3.51|0.004
91517878|NCT02184611|182910189|OTHER||Least square mean difference|-0.68||||0.386|TWO_SIDED|95.0|-2.22|0.86||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 128, UMEC Vs Placebo.||0.86|-2.22|0.386
91517879|NCT05159622|182910201|EQUIVALENCE|A net effect of 6 fluid oz/day (SD=1) was hypothesized among adult parents, assuming two sided alpha=0.05, power = 80%, and a minimum sample size of 60 adults.|Median Difference (Final Values)|3.2||||0.15|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05. P-value of the interaction between treatment group and change in beverage consumption (fl oz/day).|t-test, 2 sided|||||||0.15
91517880|NCT05159622|182910202|EQUIVALENCE|This was an exploratory outcome.|Median Difference (Final Values)|0.07||||0.98|TWO_SIDED||||||t-test, 2 sided|||||||0.98
91517881|NCT05159622|182910203|EQUIVALENCE|This was an exploratory outcome and therefore statistical power was not based on a hypothesis of this outcome.|Median Difference (Final Values)|0.64||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
91517882|NCT05159622|182910204|EQUIVALENCE|Exploratory outcome as for infants/toddlers based on parent-report|Median Difference (Final Values)|0.14||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
91517883|NCT05159622|182910205|EQUIVALENCE|Exploratory outcome|Median Difference (Final Values)|0.95||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
91517884|NCT03232983|182910214|SUPERIORITY||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.992|1.07|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.07|0.992|
91517885|NCT03232983|182910214|SUPERIORITY||Ratio of Geometric Least Squares Means|1.0|||||TWO_SIDED|90.0|0.962|1.04|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.04|0.962|
91517886|NCT03232983|182910215|SUPERIORITY||Ratio of Geometric LSMeans|1.09|||||TWO_SIDED|90.0|1.0|1.2|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.20|1.00|
91517887|NCT03232983|182910215|SUPERIORITY||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.04|1.25|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.25|1.04|
91517888|NCT02633800|182910223|OTHER|Both Log-rank test and Cox regression analysis did not adjust stratification factors.|Hazard Ratio (HR)|0.9291||||0.8342|TWO_SIDED|95.0|0.4856|1.7778||Unstratified Log-rank p-value|Log Rank|||Heregulin-high population - Patritumab vs Placebo||1.7778|0.4856|0.8342
91517889|NCT03945188|182910244|SUPERIORITY||Risk Difference (RD)|19.75|||<|0.001|TWO_SIDED|95.0|12.88|26.63|||Cochran-Mantel-Haenszel|||||26.63|12.88|<0.001
91517890|NCT03945188|182910245|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
91517891|NCT03945188|182910246|SUPERIORITY||Risk Difference (RD)|21.18|||<|0.001|TWO_SIDED|95.0|13.03|29.32|||Cochran-Mantel-Haenszel|||||29.32|13.03|<0.001
91517892|NCT03945188|182910247|SUPERIORITY||Risk Difference (RD)|26.69|||<|0.001|TWO_SIDED|95.0|18.99|34.39|||Cochran-Mantel-Haenszel|||||34.39|18.99|<0.001
91763502|NCT02178995|183417503|SUPERIORITY_OR_OTHER|||||||0.038||||||Omissions p = 0.038|ANOVA|||||||0.038
91763503|NCT02178995|183417503|SUPERIORITY_OR_OTHER|||||||0.329||||||Commissions p = 0.329|ANOVA|||||||0.329
91763504|NCT02178995|183417503|SUPERIORITY_OR_OTHER|||||||0.876|||||||t-test, 2 sided|||Hits 10mg vs 20mg||||0.876
91763505|NCT02178995|183417503|SUPERIORITY_OR_OTHER|||||||0.932|||||||t-test, 2 sided|||Omissions 10mg vs 20mg||||0.932
91763506|NCT02178995|183417503|SUPERIORITY_OR_OTHER|||||||0.898|||||||t-test, 2 sided|||Commissions 10mg vs 20mg||||0.898
91539210|NCT02954848|182956983|SUPERIORITY||Median Difference (Final Values)|3.6||||0.2146|TWO_SIDED|95.0|-1.4|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||10.700|-1.400|0.2146
91539211|NCT02954848|182956984|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
91539212|NCT02954848|182956985|SUPERIORITY|||||||0.0153|||||||Log Rank|||||||0.0153
91539213|NCT02954848|182956986|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.0757|TWO_SIDED|95.0|-0.43|0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||0.0200|-0.4300|0.0757
91539214|NCT02954848|182956986|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.3837|TWO_SIDED|95.0|-0.22|0.09|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||0.0900|-0.2200|0.3837
91539215|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6631|TWO_SIDED|95.0|-5.0|3.5|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||3.500|-5.000|0.6631
91539216|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|3.2||||0.5627|TWO_SIDED|95.0|-7.1|13.9|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||13.900|-7.100|0.5627
91539217|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|3.7||||0.0042|TWO_SIDED|95.0|0.0|8.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||8.000|0.000|0.0042
91539218|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.6452|TWO_SIDED|95.0|-9.4|6.4|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||6.400|-9.400|0.6452
91539219|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|7.4||||0.0376|TWO_SIDED|95.0|0.0|17.8|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||17.800|0.000|0.0376
91539220|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.16|TWO_SIDED|95.0|-35.7|3.6|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||3.600|-35.700|0.1600
91513972|NCT00489970|182899989|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.64||||||97.5|1.33|2.03|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||2.03|1.33|
91539221|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|3.6||||0.1032|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||10.700|0.000|0.1032
91539222|NCT02954848|182956987|SUPERIORITY||Median Difference (Final Values)|-3.3||||0.2613|TWO_SIDED|95.0|-14.3|0.2|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved response||0.200|-14.300|0.2613
91539223|NCT02954848|182956988|SUPERIORITY|||||||0.997|||||||Log Rank|||||||0.9970
91539224|NCT02954848|182956989|SUPERIORITY|||||||0.0125|||||||Log Rank|||||||0.0125
91539225|NCT02954848|182956990|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
91539226|NCT02954848|182956991|SUPERIORITY|||||||0.7999|||||||Log Rank|||||||0.7999
91539227|NCT02954848|182956992|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
91539228|NCT02954848|182956993|SUPERIORITY|||||||0.552|||||||Log Rank|||||||0.5520
91539229|NCT02954848|182956994|SUPERIORITY|||||||0.0175|||||||Log Rank|||||||0.0175
91539230|NCT02954848|182956995|SUPERIORITY|||||||0.7505|||||||Log Rank|||||||0.7505
91539231|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.7845|TWO_SIDED|95.0|-0.23|0.16|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||0.1600|-0.2300|0.7845
91539232|NCT02954848|182956996|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.11||||0.4456|TWO_SIDED|95.0|-0.33|0.17|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||0.1700|-0.3300|0.4456
91539233|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||-0.0200|-0.2900|0.0200
91539234|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|0.06||||0.4673|TWO_SIDED|95.0|-0.1|0.22|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||0.2200|-0.1000|0.4673
91539235|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|-0.29||||0.0095|TWO_SIDED|95.0|-0.53|-0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||-0.0700|-0.5300|0.0095
91539236|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|0.31||||0.165|TWO_SIDED|95.0|-0.16|0.71|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||0.7100|-0.1600|0.1650
91539237|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.2475|TWO_SIDED|95.0|-0.24|0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||0.0700|-0.2400|0.2475
91539238|NCT02954848|182956996|SUPERIORITY||Median Difference (Final Values)|0.13||||0.2367|TWO_SIDED|95.0|-0.09|0.32|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved||0.3200|-0.0900|0.2367
91539239|NCT02954848|182956997|SUPERIORITY||Median Difference (Final Values)|5.5||||0.1885|TWO_SIDED|95.0|-2.7|14.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||14.300|-2.700|0.1885
91539240|NCT02954848|182956997|SUPERIORITY||Wilcoxon Rank-Sum Test|25.6||||0.2337|TWO_SIDED|95.0|-19.2|75.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||75.000|-19.200|0.2337
91539241|NCT02954848|182956998|SUPERIORITY|||||||0.0811|||||||Log Rank|||||||0.0811
91763507|NCT02178995|183417504|SUPERIORITY_OR_OTHER|||||||0.7116|||||||t-test, 2 sided|||Comparison of baseline rate of seizures (expressed as seizures per 28 days) pre-trial against the rate experienced during the double-blind portion of our trial.||||0.7116
91763508|NCT02178995|183417505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Attention/Concentration subscale||||<0.0001
91763509|NCT02178995|183417505|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Memory subscale||||<0.0001
91763510|NCT02178995|183417505|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Language subscale||||0.002
91763511|NCT02178995|183417505|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Energy/fatigue subscale||||0.001
91763512|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Hits v1 vs v5 epilepsy||||0.003
91763513|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Hits v1 vs v5 healthy||||0.033
91763514|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANOVA|||2-way ANOVA epilepsy vs healthy hits||||0.079
91517893|NCT03945188|182910248|SUPERIORITY||Risk Difference (RD)|24.55|||<|0.001|TWO_SIDED|95.0|15.46|33.63|||Cochran-Mantel-Haenszel|||||33.63|15.46|<0.001
91517894|NCT03945188|182910249|SUPERIORITY||Risk Difference (RD)|24.89|||<|0.001|TWO_SIDED|95.0|16.17|33.6|||Cochran-Mantel-Haenszel|||||33.60|16.17|<0.001
91517895|NCT03945188|182910250|SUPERIORITY||Risk Difference (RD)|16.88|||<|0.001|TWO_SIDED|95.0|10.78|22.98|||Cochran-Mantel-Haenszel|||||22.98|10.78|<0.001
91517896|NCT03945188|182910251|SUPERIORITY||Risk Difference (RD)|18.39|||<|0.001|TWO_SIDED|95.0|11.39|25.39|||Cochran-Mantel-Haenszel|||||25.39|11.39|<0.001
91517897|NCT03945188|182910252|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
91517898|NCT03945188|182910253|SUPERIORITY||Risk Difference (RD)|15.84|||<|0.001|TWO_SIDED|95.0|10.66|21.03|||Cochran-Mantel-Haenszel|||||21.03|10.66|<0.001
91517899|NCT03945188|182910254|SUPERIORITY||Risk Difference (RD)|28.27|||<|0.001|TWO_SIDED|95.0|18.51|38.02|||Cochran-Mantel-Haenszel|||||38.02|18.51|<0.001
91517900|NCT03945188|182910255|SUPERIORITY||Risk Difference (RD)|24.93|||<|0.001|TWO_SIDED|95.0|15.79|34.07|||Cochran-Mantel-Haenszel|||||34.07|15.79|<0.001
91517901|NCT03945188|182910256|SUPERIORITY||Risk Difference (RD)|26.16|||<|0.001|TWO_SIDED|95.0|17.48|34.84|||Cochran-Mantel-Haenszel|||||34.84|17.48|<0.001
91517902|NCT03945188|182910257|SUPERIORITY||Risk Difference (RD)|11.32|||<|0.001|TWO_SIDED|95.0|6.49|16.14|||Cochran-Mantel-Haenszel|||||16.14|6.49|<0.001
91517903|NCT03945188|182910258|SUPERIORITY||Risk Difference (RD)|10.23|||<|0.001|TWO_SIDED|95.0|4.73|15.73|||Cochran-Mantel-Haenszel|||||15.73|4.73|<0.001
91517904|NCT03945188|182910259|SUPERIORITY||Risk Difference (RD)|20.39|||<|0.001|TWO_SIDED|95.0|13.79|26.98|||Cochran-Mantel-Haenszel|||||26.98|13.79|<0.001
91517905|NCT03945188|182910260|SUPERIORITY||Risk Difference (RD)|9.16|||<|0.001|TWO_SIDED|95.0|4.93|13.38|||Cochran-Mantel-Haenszel|||||13.38|4.93|<0.001
91517906|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|6.49|||=|0.049|TWO_SIDED|95.0|0.02|12.95|||Cochran-Mantel-Haenszel|||Week 2||12.95|0.02|=0.049
91517907|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|15.03|||<|0.001|TWO_SIDED|95.0|7.32|22.74|||Cochran-Mantel-Haenszel|||Week 4||22.74|7.32|<0.001
91517908|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|16.85|||<|0.001|TWO_SIDED|95.0|8.06|25.63|||Cochran-Mantel-Haenszel|||Week 8||25.63|8.06|<0.001
91517909|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|21.66|||<|0.001|TWO_SIDED|95.0|12.71|30.61|||Cochran-Mantel-Haenszel|||Week 16||30.61|12.71|<0.001
91517910|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|23.74|||<|0.001|TWO_SIDED|95.0|14.98|32.51|||Cochran-Mantel-Haenszel|||Week 20||32.51|14.98|<0.001
91517911|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|21.04|||<|0.001|TWO_SIDED|95.0|11.83|30.24|||Cochran-Mantel-Haenszel|||Week 24||30.24|11.83|<0.001
91517912|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|25.82|||<|0.001|TWO_SIDED|95.0|17.08|34.56|||Cochran-Mantel-Haenszel|||Week 32||34.56|17.08|<0.001
91517913|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|23.47|||<|0.001|TWO_SIDED|95.0|14.8|32.14|||Cochran-Mantel-Haenszel|||Week 40||32.14|14.80|<0.001
91517914|NCT03945188|182910261|SUPERIORITY||Risk Difference (RD)|26.37|||<|0.001|TWO_SIDED|95.0|17.92|34.82|||Cochran-Mantel-Haenszel|||Week 48||34.82|17.92|<0.001
91517915|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|3.59|||=|0.057|TWO_SIDED|95.0|-0.11|7.3|||Cochran-Mantel-Haenszel|||Week 2||7.30|-0.11|=0.057
91517916|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|6.88|||=|0.007|TWO_SIDED|95.0|1.86|11.9|||Cochran-Mantel-Haenszel|||Week 4||11.90|1.86|=0.007
91517917|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|10.14|||=|0.001|TWO_SIDED|95.0|4.09|16.2|||Cochran-Mantel-Haenszel|||Week 8||16.20|4.09|=0.001
91517918|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|16.36|||<|0.001|TWO_SIDED|95.0|9.89|22.83|||Cochran-Mantel-Haenszel|||Week 12||22.83|9.89|<0.001
91517919|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|15.37|||<|0.001|TWO_SIDED|95.0|9.23|21.52|||Cochran-Mantel-Haenszel|||Week 16||21.52|9.23|<0.001
91517920|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|17.8|||<|0.001|TWO_SIDED|95.0|11.85|23.75|||Cochran-Mantel-Haenszel|||Week 20||23.75|11.85|<0.001
91517921|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|14.24|||<|0.001|TWO_SIDED|95.0|7.45|21.04|||Cochran-Mantel-Haenszel|||Week 24||21.04|7.45|<0.001
91517922|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|20.03|||<|0.001|TWO_SIDED|95.0|14.25|25.81|||Cochran-Mantel-Haenszel|||Week 32||25.81|14.25|<0.001
91517923|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|15.13|||<|0.001|TWO_SIDED|95.0|8.91|21.35|||Cochran-Mantel-Haenszel|||Week 40||21.35|8.91|<0.001
91517924|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|17.52|||<|0.001|TWO_SIDED|95.0|12.16|22.87|||Cochran-Mantel-Haenszel|||Week 48||22.87|12.16|<0.001
91517925|NCT03945188|182910262|SUPERIORITY||Risk Difference (RD)|19.86|||<|0.001|TWO_SIDED|95.0|13.75|25.98|||Cochran-Mantel-Haenszel|||Week 52||25.98|13.75|<0.001
91517926|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|4.83|||=|0.336|TWO_SIDED|95.0|-5.01|14.68|||Cochran-Mantel-Haenszel|||Week 2||14.68|-5.01|=0.336
91517927|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|17.11|||<|0.001|TWO_SIDED|95.0|7.06|27.15|||Cochran-Mantel-Haenszel|||Week 4||27.15|7.06|<0.001
91517928|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|20.17|||<|0.001|TWO_SIDED|95.0|10.15|30.19|||Cochran-Mantel-Haenszel|||Week 8||30.19|10.15|<0.001
91539242|NCT02954848|182956999|SUPERIORITY|||||||0.0288|||||||Log Rank|||||||0.0288
91763515|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Omissions epilepsy v1 vs v5||||0.001
91763516|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||Omissions v1 vs v5 healthy||||0.029
91763517|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Epilepsy v healthy ANOVA Omissions||||0.048
91763518|NCT02178995|183417506|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Commissions v1 vs v5 epilepsy||||<0.0001
91763519|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Commissions v1 vs v5 healthy||||0.42
91763520|NCT02178995|183417506|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANOVA|||Healthy vs epilepsy ANOVA (2-way) commissions||||0.019
91763521|NCT02178995|183417507|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91517929|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|23.44|||<|0.001|TWO_SIDED|95.0|13.45|33.43|||Cochran-Mantel-Haenszel|||Week 12||33.43|13.45|<0.001
91517930|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|25.25|||<|0.001|TWO_SIDED|95.0|15.67|34.83|||Cochran-Mantel-Haenszel|||Week 16||34.83|15.67|<0.001
91517931|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|19.77|38.64|||Cochran-Mantel-Haenszel|||Week 20||38.64|19.77|<0.001
91517932|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|26.08|||<|0.001|TWO_SIDED|95.0|16.47|35.69|||Cochran-Mantel-Haenszel|||Week 24||35.69|16.47|<0.001
91517933|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|28.68|||<|0.001|TWO_SIDED|95.0|19.35|38.02|||Cochran-Mantel-Haenszel|||Week 32||38.02|19.35|<0.001
91517934|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|28.43|||<|0.001|TWO_SIDED|95.0|19.3|37.55|||Cochran-Mantel-Haenszel|||Week 40||37.55|19.30|<0.001
91517935|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|29.59|||<|0.001|TWO_SIDED|95.0|20.55|38.64|||Cochran-Mantel-Haenszel|||Week 48||38.64|20.55|<0.001
91517936|NCT03945188|182910263|SUPERIORITY||Risk Difference (RD)|26.43|||<|0.001|TWO_SIDED|95.0|17.18|35.68|||Cochran-Mantel-Haenszel|||Week 52||35.68|17.18|<0.001
91517937|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|5.93|||=|0.24|TWO_SIDED|95.0|-3.96|15.81|||Cochran-Mantel-Haenszel|||Week 2||15.81|-3.96|=0.240
91517938|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|7.48|27.53|||Cochran-Mantel-Haenszel|||Week 4||27.53|7.48|<0.001
91517939|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|20.93|||<|0.001|TWO_SIDED|95.0|10.92|30.94|||Cochran-Mantel-Haenszel|||Week 8||30.94|10.92|<0.001
91517940|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|24.13|||<|0.001|TWO_SIDED|95.0|14.15|34.1|||Cochran-Mantel-Haenszel|||Week 12||34.10|14.15|<0.001
91517941|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|24.51|||<|0.001|TWO_SIDED|95.0|14.89|34.13|||Cochran-Mantel-Haenszel|||Week 16||34.13|14.89|<0.001
91517942|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|29.57|||<|0.001|TWO_SIDED|95.0|20.13|39.01|||Cochran-Mantel-Haenszel|||Week 20||39.01|20.13|<0.001
91517943|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|26.45|||<|0.001|TWO_SIDED|95.0|16.88|36.02|||Cochran-Mantel-Haenszel|||Week 24||36.02|16.88|<0.001
91517944|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|29.35|||<|0.001|TWO_SIDED|95.0|20.01|38.68|||Cochran-Mantel-Haenszel|||Week 32||38.68|20.01|<0.001
91517945|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|28.83|||<|0.001|TWO_SIDED|95.0|19.71|37.95|||Cochran-Mantel-Haenszel|||Week 40||37.95|19.71|<0.001
91517946|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|30.0|||<|0.001|TWO_SIDED|95.0|20.97|39.03|||Cochran-Mantel-Haenszel|||Week 48||39.03|20.97|<0.001
91517947|NCT03945188|182910264|SUPERIORITY||Risk Difference (RD)|26.84|||<|0.001|TWO_SIDED|95.0|17.6|36.07|||Cochran-Mantel-Haenszel|||Week 52||36.07|17.60|<0.001
91517948|NCT03945188|182910265|SUPERIORITY||Risk Difference (RD)|23.05|||<|0.001|TWO_SIDED|95.0|10.2|35.9|||Cochran-Mantel-Haenszel|||||35.90|10.20|<0.001
91517949|NCT03945188|182910266|SUPERIORITY||Risk Difference (RD)|31.86|||<|0.001|TWO_SIDED|95.0|18.45|45.28|||Cochran-Mantel-Haenszel|||||45.28|18.45|<0.001
91517950|NCT04794803|182910267|SUPERIORITY||||||=|0.02164|||||||Log Rank|||||||= 0.02164
91517951|NCT04794803|182910267|SUPERIORITY||||||=|0.20043|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: Supplemental oxygen requirement based on PaO2/FiO2||||= 0.20043
91517952|NCT04794803|182910267|SUPERIORITY||||||=|0.30215|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first invasive mechanical ventilation||||= 0.30215
91517953|NCT04794803|182910267|SUPERIORITY|||||||0.5637|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first admission to ICU||||0.56370
91517954|NCT04794803|182910267|SUPERIORITY||||||=|0.00132|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first use of a rescue medication for any reason||||= 0.00132
91517955|NCT04794803|182910268|SUPERIORITY|||||||0.731|||||||Fisher Exact|||comparison at week 1||||0.731
91517956|NCT04794803|182910268|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOT||||1.000
91517957|NCT04794803|182910268|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
91517958|NCT04794803|182910269|SUPERIORITY|||||||0.353|||||||Fisher Exact|||at baseline||||0.353
91517959|NCT04794803|182910269|SUPERIORITY|||||||0.401|||||||Fisher Exact|||At Day 1||||0.401
91517960|NCT04794803|182910269|SUPERIORITY|||||||0.066|||||||Fisher Exact|||At Day 2||||0.066
91517961|NCT04794803|182910269|SUPERIORITY|||||||0.102|||||||Fisher Exact|||At week 1||||0.102
91763522|NCT02178995|183417508|SUPERIORITY_OR_OTHER|||||||0.003||||||Note: Stimulant side-effect score \*decreased\* with addition of open-label stimulant.|t-test, 2 sided|||||||0.003
91763523|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||BDI epilepsy v1 vs v5||||0.014
91763524|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Healthy controls BDI v1 vs v5||||0.04
91763525|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||Between-group comparison 2-way ANOVA BDI||||0.191
91763526|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 epilepsy||||0.42
91763527|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.477|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 healthy controls||||0.477
91763528|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.792|||||||ANOVA|||Between-groups comparison 2-way ANOVA BAI||||0.792
91763529|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.045|||||||t-test, 2 sided|||AES visit 1 vs visit 5 epilepsy||||0.045
91763530|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.646|||||||t-test, 2 sided|||AES visit 1 vs visit 5 healthy controls||||0.646
91763531|NCT02178995|183417509|SUPERIORITY_OR_OTHER|||||||0.222|||||||ANOVA|||Between-groups comparison 2-way ANOVA AES||||0.222
91763532|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.011|||||||t-test, 2 sided|||Health Perceptions||||0.011
91517962|NCT04794803|182910269|SUPERIORITY|||||||0.314|||||||Fisher Exact|||at EOT||||0.314
91517963|NCT04794803|182910269|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
91517964|NCT04794803|182910270|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||>0.999
91517965|NCT04794803|182910270|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||>0.999
91517966|NCT04794803|182910270|SUPERIORITY|||||||0.05||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.050
91517967|NCT04794803|182910270|SUPERIORITY|||||||0.0227||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0227
91517968|NCT04794803|182910271|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||At Day 1||||0.122
91517969|NCT04794803|182910271|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||At Day 2||||0.985
91517970|NCT04794803|182910271|SUPERIORITY|||||||0.857|||||||Wilcoxon (Mann-Whitney)|||at week 1||||0.857
91517971|NCT04794803|182910271|SUPERIORITY|||||||0.436|||||||Wilcoxon (Mann-Whitney)|||at EOT||||0.436
91517972|NCT04794803|182910271|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||At EOS||||0.350
91517973|NCT04794803|182910272|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.596|||||||Fisher Exact|||Day 1||||0.596
91517974|NCT04794803|182910272|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.667|||||||Fisher Exact|||Day 2||||0.667
91517975|NCT04794803|182910272|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.037|||||||Fisher Exact|||Week 1||||0.037
91517976|NCT04794803|182910272|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.293||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.293
91517977|NCT04794803|182910273|SUPERIORITY|||||||0.539||||||p-values are referred to a two-sided Fisher's Exact test for worsening and|Fisher Exact|||Day 1||||0.539
91517978|NCT04794803|182910273|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Day 2||||1.000
91517979|NCT04794803|182910273|SUPERIORITY|||||||0.102||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Week 1||||0.102
91517980|NCT04794803|182910273|SUPERIORITY|||||||0.119||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.119
91517981|NCT04794803|182910273|SUPERIORITY|||||||0.515||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOS||||0.515
91517982|NCT04794803|182910274|SUPERIORITY|||||||0.366||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||Week 1||||0.366
91517983|NCT04794803|182910274|SUPERIORITY|||||||0.489||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOT||||0.489
91517984|NCT04794803|182910274|SUPERIORITY|||||||0.486||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOS||||0.486
91517985|NCT04794803|182910275|SUPERIORITY|||||||0.79||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||Week 1||||0.790
91517986|NCT04794803|182910275|SUPERIORITY|||||||0.961||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOT||||0.961
91517987|NCT04794803|182910275|SUPERIORITY|||||||0.619||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOS||||0.619
91517988|NCT04794803|182910276|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
91517989|NCT04794803|182910276|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 1||||1.000
91517990|NCT04794803|182910276|SUPERIORITY|||||||0.678||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 2||||0.678
91517991|NCT04794803|182910276|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Week 1||||1.000
91517992|NCT04794803|182910276|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
91517993|NCT04794803|182910276|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOS||||1.000
91517994|NCT04794803|182910277|SUPERIORITY|||||||0.696||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||Week 1||||0.696
91517995|NCT04794803|182910277|SUPERIORITY||||||>|0.999||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOT||||>0.999
91517996|NCT04794803|182910277|SUPERIORITY|||||||0.596||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOS||||0.596
91763533|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||Overall QOL (subjectively rated by participants on the scale)||||0.01
91763534|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.164|||||||t-test, 2 sided|||Physical Function||||0.164
91763535|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.065|||||||t-test, 2 sided|||Role Limitations (Emotional)||||0.065
91763536|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||Role Limitations (Physical)||||0.014
91763537|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.128|||||||t-test, 2 sided|||Pain||||0.128
91763538|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Work/Driving/Social||||0.026
91763539|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.077|||||||t-test, 2 sided|||Emotional Wellbeing||||0.077
91763540|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Health Discouragement||||0.007
91763541|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Seizure Worry||||0.063
91517997|NCT04794803|182910278|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
91763542|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.609|||||||t-test, 2 sided|||Medication Effects||||0.609
91517998|NCT04794803|182910278|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 1||||1.000
91517999|NCT04794803|182910278|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 2||||1.000
91518000|NCT04794803|182910278|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||week 1||||1.000
91518001|NCT04794803|182910278|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
91518002|NCT04794803|182910280|SUPERIORITY|||||||0.76||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||baseline||||0.760
91518003|NCT04794803|182910280|SUPERIORITY|||||||0.394||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||Week 1||||0.394
91518004|NCT04794803|182910280|SUPERIORITY|||||||0.141||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOT||||0.141
91518005|NCT04794803|182910280|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
91518006|NCT04794803|182910281|SUPERIORITY|||||||0.5||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||baseline||||0.500
91518007|NCT04794803|182910281|SUPERIORITY|||||||0.112||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||week 1||||0.112
91518008|NCT04794803|182910281|SUPERIORITY|||||||0.277||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOT||||0.277
91518009|NCT04794803|182910281|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
91518010|NCT04794803|182910282|SUPERIORITY|||||||0.2027||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.2027
91518011|NCT04794803|182910282|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||1.0000
91518012|NCT04794803|182910282|SUPERIORITY|||||||0.4469||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Week 1 vs baseline||||0.4469
91518013|NCT04794803|182910282|SUPERIORITY|||||||0.2466||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.2466
91518014|NCT04794803|182910282|SUPERIORITY|||||||0.1752||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.1752
91518015|NCT04794803|182910283|SUPERIORITY|||||||0.6441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.6441
91518016|NCT04794803|182910283|SUPERIORITY|||||||0.3529||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3529
91518017|NCT04794803|182910283|SUPERIORITY|||||||0.3581||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.3581
91518018|NCT04794803|182910283|SUPERIORITY|||||||0.1666||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.1666
91518019|NCT04794803|182910283|SUPERIORITY|||||||0.0851||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0851
91518020|NCT04794803|182910284|SUPERIORITY|||||||0.3359||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.3359
91518021|NCT04794803|182910284|SUPERIORITY|||||||0.3136||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3136
91518022|NCT04794803|182910284|SUPERIORITY|||||||0.0441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.0441
91518023|NCT04794803|182910284|SUPERIORITY|||||||0.0965||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0965
91518024|NCT04794803|182910284|SUPERIORITY|||||||0.0519||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0519
91518025|NCT04794803|182910285|SUPERIORITY|||||||0.47||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.470
91518026|NCT04794803|182910285|SUPERIORITY|||||||0.425||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.425
91518027|NCT04794803|182910285|SUPERIORITY|||||||0.086||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.086
91518028|NCT04794803|182910285|SUPERIORITY|||||||0.6||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.600
91518029|NCT04794803|182910285|SUPERIORITY|||||||0.717||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.717
91539243|NCT02954848|182957000|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.1488|TWO_SIDED|95.0|-0.42|0.04|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||0.0400|-0.4200|0.1488
91539244|NCT02954848|182957000|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.44||||0.3778|TWO_SIDED|95.0|-1.57|0.69|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||0.6900|-1.5700|0.3778
91539245|NCT03299816|182957015|SUPERIORITY|||||||0.17||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.17
91539246|NCT03299816|182957016|SUPERIORITY|||||||0.36||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.36
91539247|NCT03299816|182957017|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.33
91539248|NCT03299816|182957018|SUPERIORITY|||||||0.61||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.61
91539249|NCT03299816|182957019|SUPERIORITY|||||||0.73||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.73
91539250|NCT03299816|182957020|SUPERIORITY|||||||0.75||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.75
91539251|NCT01184508|182957022|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference (Net)|-1.03||||0.085|TWO_SIDED|90.0|-2.02|-0.05||The comparison between LY2300559 and placebo for the LS mean change from baseline to Month 3 in the number of migraine attacks was conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||-0.05|-2.02|0.085
91539252|NCT01184508|182957024|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|1.75||||0.77|TWO_SIDED|90.0|-8.27|11.76||The p-value is for the change from baseline to Month 3 in average duration of photophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||11.76|-8.27|0.770
91539253|NCT01184508|182957024|SUPERIORITY_OR_OTHER||LS mean difference|7.3||||0.276|TWO_SIDED|90.0|-3.91|18.52||The p-value is for the change from baseline to Month 3 in average duration of phonophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||18.52|-3.91|0.276
91539254|NCT01184508|182957024|SUPERIORITY_OR_OTHER||LS mean difference|-2.7||||0.606|TWO_SIDED|90.0|-11.51|6.1||The p-value is for the change from baseline to Month 3 in average duration of nausea.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||6.10|-11.51|0.606
91539255|NCT01184508|182957025|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.57||||0.174|TWO_SIDED|90.0|-3.48|0.34||The p-value is for the mean change from baseline to Month 3 in the number of migraine days.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||0.34|-3.48|0.174
91539256|NCT01184508|182957028|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.27||||0.963|TWO_SIDED|90.0|-9.76|9.23||The p-value is for the change from baseline to Week 12 in MSQ restrictive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||9.23|-9.76|0.963
91539257|NCT01184508|182957028|SUPERIORITY_OR_OTHER||LS mean difference|-2.17||||0.591|TWO_SIDED|90.0|-8.85|4.5||The p-value is for the change from baseline to Week 12 in MSQ preventive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||4.50|-8.85|0.591
91539258|NCT01184508|182957028|SUPERIORITY_OR_OTHER||LS mean difference|1.89||||0.72|TWO_SIDED|90.0|-6.81|10.58||The p-value is for the change from baseline to Week 12 in MSQ emotional function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||10.58|-6.81|0.720
91539259|NCT01184508|182957029|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.25||||0.688|TWO_SIDED|90.0|-1.3|0.8||The p-value is for the change from baseline to Week 12 in MIBS-4 overall weighted score.|ANCOVA|Fixed effects: pooled investigator, treatment group, and baseline.||||0.80|-1.30|0.688
91539260|NCT01184508|182957031|SUPERIORITY_OR_OTHER|||||||0.607||95.0||||The p-value is for the percentage of participants using breakthrough medication at Month 3.|Fisher Exact|||||||0.607
91539261|NCT05382104|182957092|EQUIVALENCE|A linear mixed-effects model was applied to natural log (ln)-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) confidence intervals (CIs) was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|76.62|||||TWO_SIDED|90.0|71.78|81.78|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||81.78|71.78|
91539262|NCT05382104|182957092|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|71.61|||||TWO_SIDED|90.0|67.14|76.37|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||76.37|67.14|
91539263|NCT05382104|182957093|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.13|||||TWO_SIDED|90.0|80.74|87.66|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||87.66|80.74|
91763543|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.626|||||||t-test, 2 sided|||Social Support||||0.626
91763544|NCT02178995|183417510|SUPERIORITY_OR_OTHER|||||||0.103|||||||t-test, 2 sided|||Social Isolation||||0.103
91763545|NCT02178995|183417511|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Variability v1 vs v5 epilepsy||||<0.0001
91763546|NCT02178995|183417511|SUPERIORITY_OR_OTHER|||||||0.096|||||||t-test, 2 sided|||Variability v1 vs v5 healthy||||0.096
91763547|NCT02178995|183417511|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANOVA|||Variability 2-way ANOVA healthy vs epilepsy||||0.136
91763548|NCT02178995|183417511|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||Perseverations v1 vs v5 epilepsy||||0.17
91518030|NCT01618162|182910286|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.02|||<|0.001|TWO_SIDED|95.0|-1.18|-0.87|||ANCOVA|||Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.||-0.87|-1.18|< 0.001
91518031|NCT02013622|182910293|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.||The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
91518032|NCT02013622|182910294|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
91518033|NCT02013622|182910295|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
91518034|NCT02013622|182910298|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0003
91518035|NCT02013622|182910299|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0002
91518036|NCT02013622|182910300|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0177
91518037|NCT02013622|182910301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 effectiveness||||<0.0001
91518038|NCT02013622|182910301|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 side effects||||0.0031
91518039|NCT02013622|182910301|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 convenience||||0.0005
91518040|NCT02013622|182910301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 global satisfaction||||<0.0001
91518041|NCT02013622|182910302|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)||||0.5133
91518042|NCT02013622|182910302|SUPERIORITY_OR_OTHER|||||||0.3774|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)||||0.3774
91518043|NCT02013622|182910303|SUPERIORITY_OR_OTHER|||||||0.8897|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)||||0.8897
91518044|NCT02013622|182910303|SUPERIORITY_OR_OTHER|||||||0.3401|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)||||0.3401
91518045|NCT02013622|182910304|SUPERIORITY_OR_OTHER|||||||0.4265|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DDT||||0.4265
91518046|NCT02013622|182910305|SUPERIORITY_OR_OTHER|||||||0.2923|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value||||0.2923
91518047|NCT02013622|182910305|SUPERIORITY_OR_OTHER|||||||0.9416|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value||||0.9416
91518048|NCT02013622|182910306|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DRT||||0.1815
91518049|NCT02013622|182910307|SUPERIORITY_OR_OTHER|||||||0.6648|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for food||||0.6648
91518050|NCT02013622|182910307|SUPERIORITY_OR_OTHER|||||||0.9812|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for money||||0.9812
91518051|NCT02013622|182910309|SUPERIORITY_OR_OTHER|||||||0.0306|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16||||0.0306
91518052|NCT02192502|182910346|NON_INFERIORITY|The non-inferiority delta of a ratio of geometric means is 1.15.|Geometric mean ratio|0.91||||0.15|TWO_SIDED|95.0|0.57|1.44|||generalized linear model|This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.||Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients||1.44|0.57|0.15
91518053|NCT02192502|182910347|NON_INFERIORITY|the delta for non-inferiority is 1.15|Risk Ratio (RR)|2.78||||0.92|TWO_SIDED|95.0|0.64|12.1|||Chi-squared|||||12.1|0.64|0.92
91518054|NCT02192502|182910348|NON_INFERIORITY|the non-inferiority delta was 1.15|geometric mean ratio|0.45||||0.002|TWO_SIDED|5.0|0.21|0.95|||Regression, Linear|IL-18 was log-transformed||||0.95|0.21|0.002
91518055|NCT02192502|182910349|NON_INFERIORITY|the delta for non-inferiority is 1.15|geometric mean ratio|0.98||||0.31|TWO_SIDED|95.0|0.45|2.1|||Regression, Linear|IL-18 was log-transformed||||2.10|0.45|0.31
91518056|NCT02192502|182910350|NON_INFERIORITY|The non-inferiority delta was 1.15|Risk Ratio (RR)|0.8|||<|0.001|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||||1.03|0.61|<0.001
91539264|NCT05382104|182957093|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.35|||||TWO_SIDED|90.0|83.87|90.96|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||90.96|83.87|
91539265|NCT05382104|182957094|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.74|||||TWO_SIDED|90.0|81.28|88.34|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||88.34|81.28|
91539266|NCT05382104|182957094|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.84|||||TWO_SIDED|90.0|84.3|91.53|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||91.53|84.30|
91539267|NCT01227707|182957112|SUPERIORITY_OR_OTHER|||||||1|||||||one sample binomial test|||||||1.00
91539268|NCT03215927|182957128|SUPERIORITY||Median Difference (Net)|-2.55|STANDARD_ERROR_OF_MEAN|3.34|<|0.05|TWO_SIDED|95.0|-9.36|4.26|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||4.26|-9.36|<0.05
91539269|NCT03215927|182957129|SUPERIORITY||Hazard Ratio (HR)|0.66|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED|95.0|0.16|2.77|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||2.77|0.16|<0.05
91763549|NCT02178995|183417511|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||Perseverations v1 vs v5 healthy||||0.104
91763550|NCT02178995|183417511|SUPERIORITY_OR_OTHER|||||||0.661|||||||ANOVA|||Perseverations 2-way ANOVA healthy vs epilepsy||||0.661
91539270|NCT03215927|182957130|SUPERIORITY||Mean Difference (Net)|7.51|STANDARD_ERROR_OF_MEAN|8.12|<|0.05|TWO_SIDED|95.0|-8.8|23.83|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||23.83|-8.80|<0.05
91539271|NCT03215927|182957131|SUPERIORITY||Hazard Ratio (HR)|0.42|STANDARD_ERROR_OF_MEAN|1.16|<|0.05|TWO_SIDED|95.0|0.04|4.02|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||4.02|0.04|<0.05
91539272|NCT03779048|182957134|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.11||||0.24|TWO_SIDED||||||Regression, Linear|Controls for postprandial increases in GLP-1 and gastric emptying (acetaminophen tests)||||||.24
91763551|NCT02178995|183417512|SUPERIORITY_OR_OTHER|||||||0.397|||||||ANOVA|||Variability ANOVA||||0.397
91763552|NCT02178995|183417512|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|||Perseverations ANOVA||||0.745
91763553|NCT02178995|183417512|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 2 sided|||10mg vs 20mg variability||||0.362
91763554|NCT02178995|183417512|SUPERIORITY_OR_OTHER|||||||0.745|||||||t-test, 2 sided|||10mg vs 20mg perseverations||||0.745
91763555|NCT02178995|183417513|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||HRT ANOVA||||0.48
91763556|NCT02178995|183417513|SUPERIORITY_OR_OTHER|||||||0.793|||||||t-test, 2 sided|||HRT 10mg vs 20mg||||0.793
91763557|NCT02178995|183417514|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 2 sided|||HRT v1 vs v5 epilepsy||||0.5
91763558|NCT02178995|183417514|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||HRT v1 vs v5 healthy||||0.075
91763559|NCT02178995|183417514|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|||HRT epilepsy vs healthy ANOVA||||0.2
91763560|NCT00287222|183417515|SUPERIORITY_OR_OTHER||percentage progression free at 27 weeks|28.0|STANDARD_ERROR_OF_MEAN|10.97||0.0006|TWO_SIDED|95.0|10.0|53.0|||one-sided exact binomial test|||Estimating the percentage of participants that remain free of disease progression at 27 weeks from the onset of treatment, and testing that proportion against a null-hypothesis proportion of 0.04 using the one-sided exact binomial test at 5% alpha, based upon historical data from the literature.||53|10|0.0006
91513973|NCT00489970|182899989|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.37|6.36|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.36|4.37|
91513974|NCT00489970|182899989|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|4.47|||||TWO_SIDED|97.5|3.58|5.57|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||5.57|3.58|
91513975|NCT00489970|182899990|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-5.91|||||TWO_SIDED|97.5|-14.67|2.85|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.85|-14.67|
91513976|NCT00489970|182899990|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.44|||||TWO_SIDED|97.5|-10.63|7.79|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||7.79|-10.63|
91513977|NCT00489970|182899990|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-8.56|||||TWO_SIDED|97.5|-20.33|2.73|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.73|-20.33|
91513978|NCT00489970|182899990|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-11.79|||||TWO_SIDED|97.5|-22.98|0.15|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||0.15|-22.98|
91513979|NCT00489970|182899991|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-2.85|||||TWO_SIDED|97.5|-9.09|3.08|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||3.08|-9.09|
91513980|NCT00489970|182899991|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-7.05|||||TWO_SIDED|97.5|-13.16|-1.4|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||-1.40|-13.16|
91518057|NCT04818346|182910369|SUPERIORITY||Least squares mean difference|-21.41|STANDARD_ERROR_OF_MEAN|6.62||0.0015|TWO_SIDED|95.0|-34.49|-8.32|||Mixed Model Repeated Measures (MMRM)|||||-8.32|-34.49|0.0015
91518058|NCT04818346|182910369|SUPERIORITY||Least squares mean difference|-20.07|STANDARD_ERROR_OF_MEAN|6.86||0.004|TWO_SIDED|95.0|-33.63|-6.51|||MMRM|||||-6.51|-33.63|0.0040
91518059|NCT04818346|182910369|SUPERIORITY||Least squares mean difference|-18.02|STANDARD_ERROR_OF_MEAN|6.77||0.0086|TWO_SIDED|95.0|-31.4|-4.64|||MMRM|||||-4.64|-31.40|0.0086
91539273|NCT03779048|182957135|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|-0.09||||0.34|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and gastric emptying (acetaminophen test)||||||.34
91539274|NCT03779048|182957136|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.03||||0.78|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and postprandial change in GLP-1||||||.78
91539275|NCT03779048|182957137|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.1|5.1|||Mixed Models Analysis|||||5.1|1.1|.003
91539276|NCT03779048|182957138|OTHER|Correlation between baseline postprandial hunger AUC and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
91539277|NCT03779048|182957139|OTHER|Correlation between baseline high energy density food reinforcer points earned and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
91539278|NCT03779048|182957140|OTHER|Regression results using baseline AUC for delay discounting to predict 4-week percent weight loss, controlling for participant age.|r2 change|0.033||||0.033|TWO_SIDED||||||Regression, Linear|||||||.033
91539279|NCT03779048|182957141|OTHER|Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.|r|0.17||||0.04|TWO_SIDED|||||Correlation to Implicit wanting of High Fat Savory.|Regression, Linear|||||||.04
91539280|NCT03779048|182957141|OTHER|Correlation to Implicit wanting of Low Fat Savory.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted.||||.72
91513981|NCT00489970|182899991|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-10.32|||||TWO_SIDED|97.5|-17.5|-3.38|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||-3.38|-17.50|
91539281|NCT03779048|182957141|OTHER|Correlation to Implicit wanting of High Fat Sweet.|r|0.01||||0.94|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.94
91539282|NCT03779048|182957141|OTHER|Correlation to Implicit wanting of Low Fat Sweet.|r|-0.15||||0.09|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.09
91539283|NCT03779048|182957142|OTHER|Correlation between baseline fasting active ghrelin and 4-week percent weight loss.|r|0.03||||0.73|TWO_SIDED||||||Regression, Linear|||||||.73
91539284|NCT03779048|182957143|OTHER||r|-0.1||||0.25|TWO_SIDED||||||Regression, Linear|||Correlation between baseline fasting leptin and 4-week percent weight loss.||||.25
91539285|NCT03779048|182957144|OTHER|Correlation between baseline postprandial AUC for change in insulin and 4-week percent weight loss.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||||||.72
91539286|NCT03779048|182957145|OTHER|Correlation between baseline postprandial incremental AUC for PYY and 4-week percent weight loss.|r|-0.02||||0.82|TWO_SIDED||||||Regression, Linear|||||||.82
91539287|NCT03779048|182957146|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.002|TWO_SIDED|95.0|1.1|5.0|||Mixed Models Analysis|||||5.0|1.1|.002
91539288|NCT03779048|182957151|SUPERIORITY|Difference between placebo- and phentermine-treated participants in change in delay discounting area under the curve from randomization to week 24 was calculated using repeated measures ANCOVA, controlling for age.|F|0.17||||0.68|TWO_SIDED||||||ANCOVA|||||||.68
91539289|NCT03779048|182957152|OTHER|Regression using the three Eating Inventory subscales (Cognitive restraint, disinhibition, hunger) to predict 4-week weight loss|r2|0.01||||0.75|TWO_SIDED|||||For full model including all 3 predictors|Regression, Linear|||||||.75
91539290|NCT03779048|182957153|OTHER|Correlation between baseline past-week appetite and 4-week percent weight loss.|r|-0.09||||0.31|TWO_SIDED||||||Regression, Linear|||||||.31
91539291|NCT03779048|182957155|OTHER|Regression using baseline scores for Behavioral Inhibition (BIS) and Behavioral Activation fro Reward to predict 4-week weight loss during the behavioral treatment run-in.|r2|0.05||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
91539292|NCT03779048|182957156|OTHER|Correlation between baseline BIS-15 total score and 4-week percent weight loss.|r|0.03||||0.76|TWO_SIDED||||||Regression, Linear|||||||.76
91539293|NCT05328297|182957179|SUPERIORITY||Least Square Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.96|=|0.438|TWO_SIDED|80.0|-2.84|2.23|||Mixed Model for Repeated Measures (MMRM)|||||2.23|-2.84|=0.438
91539294|NCT01286272|182957206|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8457|TWO_SIDED|95.0|0.51|1.74|||Log Rank|||||1.74|0.51|0.8457
91539295|NCT02945332|182957211|SUPERIORITY||Mean Difference (Net)|4.35|STANDARD_ERROR_OF_MEAN|4.85||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
91539296|NCT02945332|182957212|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
91539297|NCT02945332|182957213|SUPERIORITY||Mean Difference (Net)|4.79|STANDARD_ERROR_OF_MEAN|3.68||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
91539298|NCT02945332|182957214|SUPERIORITY||Mean Difference (Net)|11.36|STANDARD_ERROR_OF_MEAN|15.32||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
91539299|NCT02945332|182957215|SUPERIORITY||Mean Difference (Net)|-8.03|STANDARD_ERROR_OF_MEAN|31.36||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
91539300|NCT02945332|182957216|SUPERIORITY||Mean Difference (Net)|2.98|STANDARD_ERROR_OF_MEAN|4.16||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.42
91539301|NCT03979365|182957218|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||||||0.944
91539302|NCT03979365|182957219|SUPERIORITY|||||||0.345|||||||Kruskal-Wallis|||Trembling Hands||||0.345
91539303|NCT03979365|182957219|SUPERIORITY|||||||0.451|||||||Kruskal-Wallis|||Muscle Cramps||||0.451
91539304|NCT03979365|182957219|SUPERIORITY|||||||0.953|||||||Kruskal-Wallis|||Muscle Weakness||||0.953
91539305|NCT03979365|182957219|SUPERIORITY|||||||0.579|||||||Kruskal-Wallis|||Swollen Gums||||0.579
91539306|NCT03979365|182957219|SUPERIORITY|||||||0.513|||||||Kruskal-Wallis|||Increased Hair Growth||||0.513
91539307|NCT03979365|182957220|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
91539308|NCT03979365|182957223|SUPERIORITY|||||||0.836|||||||t-test, 2 sided|||||||0.836
91539309|NCT03979365|182957224|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
91539310|NCT03979365|182957225|SUPERIORITY|||||||0.314|||||||Kruskal-Wallis|||Taste Change||||0.314
91539311|NCT03979365|182957225|SUPERIORITY|||||||0.486|||||||Kruskal-Wallis|||Appetite||||0.486
91539312|NCT03979365|182957225|SUPERIORITY|||||||0.452|||||||Kruskal-Wallis|||Constipation||||0.452
91539313|NCT03979365|182957225|SUPERIORITY|||||||0.75|||||||Kruskal-Wallis|||Diarrhea||||0.750
91539314|NCT03979365|182957225|SUPERIORITY|||||||0.764|||||||Kruskal-Wallis|||Swelling||||0.764
91539315|NCT03979365|182957225|SUPERIORITY|||||||0.726|||||||Kruskal-Wallis|||Palpitations||||0.726
91539316|NCT03979365|182957225|SUPERIORITY|||||||0.421|||||||Kruskal-Wallis|||Dry Skin||||0.421
91539317|NCT03979365|182957225|SUPERIORITY|||||||0.679|||||||Kruskal-Wallis|||Darker Skin||||0.679
91539318|NCT03979365|182957225|SUPERIORITY|||||||0.779|||||||Kruskal-Wallis|||Blurry Vision||||0.779
91539319|NCT03979365|182957225|SUPERIORITY|||||||0.533|||||||Kruskal-Wallis|||Headache||||0.533
91539320|NCT03979365|182957225|SUPERIORITY|||||||0.668|||||||Kruskal-Wallis|||Insomnia||||0.668
91539321|NCT03979365|182957225|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Fatigue||||1.00
91539322|NCT03979365|182957225|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||Anxiety||||0.232
91539323|NCT03979365|182957225|SUPERIORITY|||||||0.566|||||||Kruskal-Wallis|||Depression||||0.566
91539324|NCT03979365|182957225|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||Sadness||||0.038
91539325|NCT03979365|182957226|SUPERIORITY|||||||0.754|||||||Kruskal-Wallis|||||||0.754
91539326|NCT03979365|182957228|SUPERIORITY|||||||0.371|||||||Kruskal-Wallis|||||||0.371
91539327|NCT02296424|182957309|EQUIVALENCE|nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.||||||0.0001|||||||exact binomial test|||||||0.0001
91539328|NCT02680457|182957315|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.630
91539329|NCT02680457|182957316|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91539330|NCT01112670|182957317|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
91539331|NCT01112670|182957318|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
91539332|NCT01112670|182957319|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
91539333|NCT01112670|182957320|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||||||0.56
91539334|NCT01112670|182957321|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
91539335|NCT01112670|182957322|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||||||0.86
91539336|NCT01112670|182957323|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANOVA|||||||0.21
91539337|NCT01112670|182957324|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
91539338|NCT01112670|182957325|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
91539339|NCT01112670|182957326|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANOVA|||||||0.29
91539340|NCT01112670|182957327|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
91539341|NCT01192542|182957354|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0064|||TWO_SIDED|95.0|-0.022|0.003|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.|The mean difference is calculated as: Test lens - Control lens.|The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.003|-0.022|
91539342|NCT01192542|182957357|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0091|||TWO_SIDED|95.0|-0.018|0.018|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.||The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.018|-0.018|
91539343|NCT05694065|182957361|OTHER||||||||||||||||||The diagnostic discrimination ability of UFR was analyzed by ROC curve analysis using the DeLong method. Cutoff value of ≤0.80 was used for FFR and UFR to define the physiological significance of a coronary stenosis, with two-sided P\<0.05 considered statistically significant.|||
91539344|NCT05694065|182957365|OTHER||||||||||||||||||The diagnostic discrimination abilities of UFR and MLA were compared by ROC curves analysis using the DeLong method. A prespecified MLA cutoff value was applied based on the prior study. Cutoff value of ≤0.80 was used for FFR and UFR to define the physiological significance of a coronary stenosis, with two-sided P\<0.05 considered statistically significant.|||
91539345|NCT01087762|182957366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||=|0.004|TWO_SIDED|95.0|6.3|32.4||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||32.4|6.3|=0.004
91539346|NCT01087762|182957366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|||<|0.001|TWO_SIDED|95.0|12.3|38.2||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.2|12.3|<0.001
91539347|NCT01087762|182957367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.7|||<|0.001|TWO_SIDED|95.0|25.4|50.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||50.0|25.4|<0.001
91539348|NCT01087762|182957367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|28.9|53.3||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||53.3|28.9|<0.001
91539349|NCT01087762|182957368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.96|-1.01||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.01|-1.96|<0.001
91539350|NCT01087762|182957369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.38|-1.38||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.38|-2.38|<0.001
91539351|NCT01087762|182957370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.12||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.12|-2.07|<0.001
91539352|NCT01087762|182957371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.49|-1.5||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.50|-2.49|<0.001
91539353|NCT01087762|182957372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.60|<0.001
91539354|NCT01087762|182957373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.66|-0.23||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.23|-0.66|<0.001
91539355|NCT01256034|182957376|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
91763561|NCT02114606|183417517|OTHER|Overall agreement was calculated using Cohen's Kappa, with endoscopic biopsy as the gold standard.||||||0.0001||||||A p-value of \<0.05 was considered statistically significant.|Cohen's Kappa|||All participants enrolled (EoE Patients) provided both a Cytosponge specimen and endoscopic biopsy. The results of these specimens were compared to examine overall agreement.||||0.0001
91763562|NCT01910402|183417534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%|Adjusted difference in proportion|10.5||||0.005|TWO_SIDED|95.0|3.1|17.8||If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.|Cochran-Mantel-Haenszel|||||17.8|3.1|0.005
91763563|NCT01910402|183417556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026||||0.7053|TWO_SIDED|95.0|-0.159|0.107|||Multiple Imputed Dataset - MAR|||||0.107|-0.159|0.7053
91763564|NCT01910402|183417557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.106||||0.3165|TWO_SIDED|95.0|-0.313|0.101|||Multiple Imputed Dataset - MAR|||||0.101|-0.313|0.3165
91763565|NCT01910402|183417572|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.729|||<|0.001|TWO_SIDED|95.0|0.683|0.779|||ANCOVA||BSAP ratio of Week 48 result over Baseline|||0.779|0.683|<0.001
91763566|NCT01910402|183417572|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.693|||<|0.001|TWO_SIDED|95.0|0.647|0.741|||ANCOVA||PTP ratio of Week 48 result over Baseline|||0.741|0.647|<0.001
91763567|NCT01910402|183417572|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.629|||<|0.001|TWO_SIDED|95.0|0.581|0.68|||ANCOVA||Osteocalcin ratio of Week 48 result over Baseline|||0.680|0.581|<0.001
91518060|NCT04818346|182910370|SUPERIORITY||Odds Ratio (OR)|4.3||||0.3574|TWO_SIDED|95.0|0.398|220.998|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||220.998|0.398|0.3574
91518061|NCT04818346|182910370|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1992|TWO_SIDED|95.0|0.573|273.479|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||273.479|0.573|0.1992
91518062|NCT04818346|182910370|SUPERIORITY||Odds Ratio (OR)|2.1||||0.9913|TWO_SIDED|95.0|0.103|126.386|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||126.386|0.103|0.9913
91518063|NCT02273141|182910395|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|8.22||||0.038|ONE_SIDED|97.5|-0.5|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate non-inferiority (NI) of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-0.50|0.038
91518064|NCT02273141|182910396|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|3.2||||0.027|ONE_SIDED|97.5|-5.56|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-5.56|0.027
91518065|NCT02273141|182910397|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|2.42||||0.154|TWO_SIDED|95.0|-6.35|11.12||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.12|-6.35|0.154
91518066|NCT02273141|182910398|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.27||||0.212|TWO_SIDED|95.0|-5.56|11.91||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.91|-5.56|0.212
91539356|NCT01596504|182957394|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-6.01|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|ONE_SIDED|95.0|-7.77|||p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025:no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1.2 mg|Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-7.77|<0.0001
91539357|NCT01596504|182957394|SUPERIORITY_OR_OTHER||LS mean difference|-4.61|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|ONE_SIDED|95.0|-6.34|||p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025: no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1. 8 mg|Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-6.34|<0.0001
91539358|NCT02716324|182957411|SUPERIORITY||Beta Coefficient|0.001||||0.871|TWO_SIDED|95.0|-0.01|0.012|||GLS random-effects model|||Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.012|-0.010|.871
91539359|NCT02716324|182957412|SUPERIORITY||Beta coefficient|0.001||||0.499|TWO_SIDED|95.0|-0.002|0.004|||Random effects model|||Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.004|-0.002|0.499
91539360|NCT02716324|182957413|SUPERIORITY|||||||0.718|||||||Chi-squared|||Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.||||0.718
91539361|NCT02716324|182957413|SUPERIORITY|||||||0.903|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.||||0.903
91539362|NCT02716324|182957413|SUPERIORITY|||||||0.915|||||||Chi-squared|||Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.||||0.915
91539363|NCT02716324|182957414|SUPERIORITY|||||||0.31|||||||Chi-squared|||Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.||||0.310
91539364|NCT02716324|182957414|SUPERIORITY|||||||0.251|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.||||0.251
91539365|NCT02716324|182957414|SUPERIORITY|||||||1|||||||Chi-squared|||Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.||||1.00
91539366|NCT02716324|182957415|SUPERIORITY||Beta coefficient|0.0||||0.662|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.662
91539367|NCT02716324|182957415|SUPERIORITY||Beta coefficient|0.001||||0.075|TWO_SIDED|95.0|0.0|0.002|||Random effects model|||Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.002|0.000|0.075
91539368|NCT02716324|182957416|SUPERIORITY||Beta coefficient|0.0||||0.707|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.707
91539369|NCT02716324|182957416|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
91539370|NCT02716324|182957417|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
91539371|NCT02716324|182957418|SUPERIORITY||Beta coefficient|0.0||||0.873|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.873
91763568|NCT01910402|183417572|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.655|||<|0.0001|TWO_SIDED|95.0|0.609|0.706|||ANCOVA||Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline|||0.706|0.609|<0.0001
91763569|NCT01910402|183417572|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.852|||<|0.0001|TWO_SIDED|95.0|0.794|0.914|||ANCOVA||Vitamin D ratio of Week 48 result over Baseline|||0.914|0.794|<0.0001
91763570|NCT01910402|183417574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||Week 4|Wilcoxon (Mann-Whitney)|||||||0.016
91539372|NCT02716324|182957418|SUPERIORITY||Beta coefficient|0.0||||0.888|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.888
91539373|NCT02716324|182957419|SUPERIORITY||Beta coefficient|0.0||||0.679|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.679
91539374|NCT02716324|182957420|SUPERIORITY||Beta coefficient|0.074||||0.495|TWO_SIDED|95.0|-0.164|0.311|||Random effects model|||Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.311|-0.164|0.495
91539375|NCT02716324|182957420|SUPERIORITY||Beta coefficient|-0.013||||0.885|TWO_SIDED|95.0|-0.217|0.191|||Random effects model|||Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.191|-0.217|0.885
91539376|NCT02716324|182957420|SUPERIORITY||Beta coefficient|0.073||||0.527|TWO_SIDED|95.0|-0.182|0.328|||Random effects model|||Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.328|-0.182|0.527
91539377|NCT02716324|182957420|SUPERIORITY||Beta coefficient|0.136||||0.285|TWO_SIDED|95.0|-0.138|0.41|||Random effects model|||Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.410|-0.138|0.285
91539378|NCT04347954|182957424|OTHER||Mean Difference (Net)|-0.349|||||TWO_SIDED|95.0|-1.584|0.886||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.886|-1.584|
91539379|NCT04347954|182957424|OTHER||Mean Difference (Net)|-1.059|||||TWO_SIDED|95.0|-2.318|0.201||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.201|-2.318|
91539380|NCT03257813|182957435|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.013||||||Baseline|t-test, 2 sided|||||||0.013
91539381|NCT03257813|182957435|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.001||||||CrossOver|t-test, 2 sided|||||||0.001
91539382|NCT03257813|182957435|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.05||||||Final Visit|t-test, 2 sided|||||||0.050
91539383|NCT03257813|182957436|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.823||||||Baseline|t-test, 2 sided|||||||0.823
91539384|NCT03257813|182957436|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.507||||||CrossOver|t-test, 2 sided|||||||0.507
91539385|NCT03257813|182957436|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.495||||||Final Visit|t-test, 2 sided|||||||0.495
91539386|NCT03257813|182957437|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.085|||||||Chi-squared|||||||0.085
91539387|NCT03257813|182957438|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.001||||||Baseline|Fisher Exact|||||||0.001
91539388|NCT03257813|182957438|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.148||||||CrossOver|Fisher Exact|||||||0.148
91539389|NCT03257813|182957438|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.212||||||Final Visit|Fisher Exact|||||||0.212
91539390|NCT03257813|182957439|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||Baseline|Chi-squared, Corrected|||||||0.497
91539391|NCT03257813|182957439|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||CrossOver|Chi-squared, Corrected|||||||0.497
91539392|NCT03257813|182957439|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0||||||"Final Visit~No statistic will be calculated because Final Chemosis is a constant"|Chi-squared, Corrected|||||||0
91539393|NCT03257813|182957440|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||baseline|Chi-squared|||||||1.000
91539394|NCT03257813|182957440|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.391||||||Cross Over|Chi-squared|||||||0.391
91539395|NCT03257813|182957440|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.534||||||Final Visit|Chi-squared|||||||0.534
91539396|NCT03257813|182957441|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.023||||||Baseline|Chi-squared, Corrected|||||||0.023
91539397|NCT03257813|182957441|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
91539398|NCT03257813|182957441|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.793||||||Final Visit|Chi-squared|||||||0.793
91539399|NCT03257813|182957442|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.825||||||Baseline|Chi-squared|||||||0.825
91539400|NCT03257813|182957442|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
91539401|NCT03257813|182957442|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.765|||||||Chi-squared|||||||0.765
91539402|NCT04141917|182957451|SUPERIORITY||Risk Ratio, log|1.33|||||TWO_SIDED|95.0|0.35|5.02||||||The number of influenza-positive tests was analyzed using a generalized linear mixed model following a Poisson distribution with a log link and robust variance. The model is adjusted for calendar time and an exposure time variable based on shelter capacity. This model includes symptomatic individuals who tested throughout Year 1 of the study (November 15, 2019 - March 31, 2020).||5.02|0.35|
91539403|NCT00922207|182957459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.6853|TWO_SIDED|95.0|0.46|1.75|||Cochran-Mantel-Haenszel|||||1.75|0.46|0.6853
91539404|NCT00922207|182957459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1977|TWO_SIDED|95.0|0.35|1.26|||Cochran-Mantel-Haenszel|||||1.26|0.35|0.1977
91539405|NCT00922207|182957459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.2916|TWO_SIDED|95.0|0.39|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.39|0.2916
91539406|NCT00922207|182957460|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.34||||0.0353|TWO_SIDED|95.0|0.02|0.66|||ANCOVA|||Baseline||0.66|0.02|0.0353
91763571|NCT01910402|183417574|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Week 12|Wilcoxon (Mann-Whitney)|||||||<0.001
91539407|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.1114|TWO_SIDED|95.0|-0.05|0.52|||ANCOVA|||Baseline||0.52|-0.05|0.1114
91539408|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.515|TWO_SIDED|95.0|-0.42|0.21|||ANCOVA|||Baseline||0.21|-0.42|0.5150
91539409|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.34|0.89|||ANCOVA|||Change at Week 4||0.89|0.34|<0.001
91539410|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.19|-1.65|||ANCOVA|||Change at Week 4||-1.65|-2.19|<0.001
91539411|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.54|||<|0.001|TWO_SIDED|95.0|-2.81|-2.27|||ANCOVA|||Change at Week 4||-2.27|-2.81|<0.001
91539412|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.001|TWO_SIDED|95.0|1.34|2.06|||ANCOVA|||Change at Week 8||2.06|1.34|<0.001
91539413|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55||||0.0071|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Change at Week 8||-0.15|-0.95|0.0071
91539414|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|||<|0.001|TWO_SIDED|95.0|-2.61|-1.9|||ANCOVA|||Change at Week 8||-1.90|-2.61|<0.001
91539415|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|1.16|2.08|||ANCOVA|||Change at Week 16||2.08|1.16|<0.001
91539416|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9557|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||Change at Week 16||0.53|-0.56|0.9557
91539417|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.15|-1.14|||ANCOVA|||Change at Week 16||-1.14|-2.15|<0.001
91539418|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.0094|TWO_SIDED|95.0|0.18|1.27|||ANCOVA|||Change at Week 28||1.27|0.18|0.0094
91539419|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.0943|TWO_SIDED|95.0|-0.09|1.11|||ANCOVA|||Change at Week 28||1.11|-0.09|0.0943
91763572|NCT01910402|183417574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Week 24|Wilcoxon (Mann-Whitney)|||||||0.002
91539420|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.4354|TWO_SIDED|95.0|-0.82|0.35|||ANCOVA|||Change at Week 28||0.35|-0.82|0.4354
91539421|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.2509|TWO_SIDED|95.0|-0.26|0.98|||ANCOVA|||Change at Week 40||0.98|-0.26|0.2509
91539422|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.0429|TWO_SIDED|95.0|0.02|1.31|||ANCOVA|||Change at Week 40||1.31|0.02|0.0429
91539423|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.3585|TWO_SIDED|95.0|-0.34|0.93|||ANCOVA|||Change at Week 40||0.93|-0.34|0.3585
91539424|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.9014|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA|||Change at Week 52||0.74|-0.65|0.9014
91539425|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1122|TWO_SIDED|95.0|-0.13|1.28|||ANCOVA|||Change at Week 52||1.28|-0.13|0.1122
91539426|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.1602|TWO_SIDED|95.0|-0.2|1.23|||ANCOVA|||Change at Week 52||1.23|-0.20|0.1602
91539427|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.1599|TWO_SIDED|95.0|-1.17|0.19|||ANCOVA|||Change at Week 64||0.19|-1.17|0.1599
91539428|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.5045|TWO_SIDED|95.0|-0.45|0.92|||ANCOVA|||Change at Week 64||0.92|-0.45|0.5045
91539429|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.0412|TWO_SIDED|95.0|0.03|1.41|||ANCOVA|||Change at Week 64||1.41|0.03|0.0412
91539430|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.1347|TWO_SIDED|95.0|-1.24|0.17|||ANCOVA|||Change at Week 76||0.17|-1.24|0.1347
91539431|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.4027|TWO_SIDED|95.0|-0.41|1.01|||ANCOVA|||Change at Week 76||1.01|-0.41|0.4027
91539432|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.0311|TWO_SIDED|95.0|0.07|1.55|||ANCOVA|||Change at Week 76||1.55|0.07|0.0311
91539433|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36||||0.3183|TWO_SIDED|95.0|-1.07|0.35|||ANCOVA|||Change at Week 88||0.35|-1.07|0.3183
91763573|NCT01910402|183417574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||Week 48|Wilcoxon (Mann-Whitney)|||||||0.007
91763574|NCT02660853|183417618|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Baseline versus during exacerbation.||||0.745
91763575|NCT02660853|183417622|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
91763576|NCT03594773|183417628|SUPERIORITY||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|1.56||0.752|TWO_SIDED|95.0|-3.62|2.63|||t-test, 2 sided|df=56, equal variances assumed||||2.63|-3.62|.752
91763577|NCT03594773|183417629|SUPERIORITY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|2.62||0.633|TWO_SIDED|95.0|-4.01|6.52|||t-test, 2 sided|df=49, equal variances assumed||||6.52|-4.01|.633
91539434|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.1371|TWO_SIDED|95.0|-0.17|1.22|||ANCOVA|||Change at Week 88||1.22|-0.17|0.1371
91539435|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.0113|TWO_SIDED|95.0|0.21|1.6|||ANCOVA|||Change at Week 88||1.60|0.21|0.0113
91539436|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.5608|TWO_SIDED|95.0|-0.92|0.5|||ANCOVA|||Change at Week 100||0.50|-0.92|0.5608
91539437|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.6323|TWO_SIDED|95.0|-0.53|0.88|||ANCOVA|||Change at Week 100||0.88|-0.53|0.6323
91539438|NCT00922207|182957460|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2752|TWO_SIDED|95.0|-0.32|1.11|||ANCOVA|||Change at Week 100||1.11|-0.32|0.2752
91539439|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.6107|TWO_SIDED|95.0|0.26|9.71|||Cochran-Mantel-Haenszel|||Baseline||9.71|0.26|0.6107
91539440|NCT00922207|182957461|SUPERIORITY_OR_OTHER|||||||0.0788|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.0788
91539441|NCT00922207|182957461|SUPERIORITY_OR_OTHER|||||||0.1761|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.1761
91539442|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.7044|TWO_SIDED|95.0|0.34|5.09|||Cochran-Mantel-Haenszel|||Week 4||5.09|0.34|0.7044
91539443|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.35||||0.0927|TWO_SIDED|95.0|0.61|46.76|||Cochran-Mantel-Haenszel|||Week 4||46.76|0.61|0.0927
91763578|NCT03594773|183417630|SUPERIORITY||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.73||0.586|TWO_SIDED|95.0|-2.53|4.44|||t-test, 2 sided|df=49, equal variances assumed||||4.44|-2.53|.586
91763579|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (\>) -0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).||2.1|-2.2|
91763580|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-1.7|||||TWO_SIDED|95.0|-5.2|1.1||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||1.1|-5.2|
91539444|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04||||0.1858|TWO_SIDED|95.0|0.44|36.89|||Cochran-Mantel-Haenszel|||Week 4||36.89|0.44|0.1858
91539445|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9385|TWO_SIDED|95.0|0.33|3.38|||Cochran-Mantel-Haenszel|||Week 8||3.38|0.33|0.9385
91539446|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5068|TWO_SIDED|95.0|0.43|5.77|||Cochran-Mantel-Haenszel|||Week 8||5.77|0.43|0.5068
91539447|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.5544|TWO_SIDED|95.0|0.41|5.5|||Cochran-Mantel-Haenszel|||Week 8||5.50|0.41|0.5544
91539448|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.651|TWO_SIDED|95.0|0.26|2.31|||Cochran-Mantel-Haenszel|||Week 16||2.31|0.26|0.6510
91539449|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.3192|TWO_SIDED|95.0|0.2|1.69|||Cochran-Mantel-Haenszel|||Week 16||1.69|0.20|0.3192
91539450|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|2.03|||Cochran-Mantel-Haenszel|||Week 16||2.03|0.29|0.5818
91539451|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8796|TWO_SIDED|95.0|0.41|2.66|||Cochran-Mantel-Haenszel|||Week 28||2.66|0.41|0.8796
91539452|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.305|TWO_SIDED|95.0|0.27|1.52|||Cochran-Mantel-Haenszel|||Week 28||1.52|0.27|0.3050
91539453|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.2414|TWO_SIDED|95.0|0.26|1.44|||Cochran-Mantel-Haenszel|||Week 28||1.44|0.26|0.2414
91539454|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8502|TWO_SIDED|95.0|0.5|2.22|||Cochran-Mantel-Haenszel|||Week 40||2.22|0.50|0.8502
91539455|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.5|TWO_SIDED|95.0|0.38|1.61|||Cochran-Mantel-Haenszel|||Week 40||1.61|0.38|0.5000
91539456|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3882|TWO_SIDED|95.0|0.36|1.53|||Cochran-Mantel-Haenszel|||Week 40||1.53|0.36|0.3882
91539457|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9584|TWO_SIDED|95.0|0.5|1.99|||Cochran-Mantel-Haenszel|||Week 52||1.99|0.50|0.9584
91539458|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2576|TWO_SIDED|95.0|0.35|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.35|0.2576
91539459|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2362|TWO_SIDED|95.0|0.36|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.36|0.2362
91539460|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9861|TWO_SIDED|95.0|0.49|1.9|||Cochran-Mantel-Haenszel|||Week 64||1.90|0.49|0.9861
91539461|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2919|TWO_SIDED|95.0|0.37|1.35|||Cochran-Mantel-Haenszel|||Week 64||1.35|0.37|0.2919
91539462|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2674|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 64||1.38|0.38|0.2674
91539463|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6148|TWO_SIDED|95.0|0.43|1.64|||Cochran-Mantel-Haenszel|||Week 76||1.64|0.43|0.6148
91539464|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.0904|TWO_SIDED|95.0|0.3|1.08|||Cochran-Mantel-Haenszel|||Week 76||1.08|0.30|0.0904
91539465|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2073|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 76||1.27|0.36|0.2073
91539466|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.998|TWO_SIDED|95.0|0.52|1.98|||Cochran-Mantel-Haenszel|||Week 88||1.98|0.52|0.9980
91763581|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
91763582|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
91539467|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.3489|TWO_SIDED|95.0|0.39|1.4|||Cochran-Mantel-Haenszel|||Week 88||1.40|0.39|0.3489
91539468|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.2847|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 88||1.38|0.38|0.2847
91539469|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5596|TWO_SIDED|95.0|0.44|1.62|||Cochran-Mantel-Haenszel|||Week 100||1.62|0.44|0.5596
91539470|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.2112|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 100||1.27|0.36|0.2112
91539471|NCT00922207|182957461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4066|TWO_SIDED|95.0|0.43|1.48|||Cochran-Mantel-Haenszel|||Week 100||1.48|0.43|0.4066
91539472|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.6921|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6921
91539473|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.3939|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.3939
91539474|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6818
91539475|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.7582|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7582
91539476|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.5381|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.5381
91539477|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7747
91539478|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.8034
91539479|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6306|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.6306
91539480|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.4574|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.4574
91539481|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5824|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5824
91539482|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9321|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.9321
91539483|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.5263|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5263
91539484|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.2025|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 22||||0.2025
91539485|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6702|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.6702
91539486|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.0818
91539487|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6214|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6214
91539488|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6774|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6774
91539489|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3154|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.3154
91539490|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2709|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.2709
91539491|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3804|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.3804
91539492|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7645|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.7645
91539493|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.182|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.1820
91539494|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.7167|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.7167
91539495|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3104|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.3104
91539496|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.091|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.0910
91539497|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6094|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.6094
91539498|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2166|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.2166
91539499|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.901|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9010
91539500|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9060
91539501|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.7268
91539502|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5372|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.5372
91539503|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1588|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.1588
91539504|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.4268
91539505|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.4389|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.4389
91539506|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6708|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.6708
91539507|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2145|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.2145
91539508|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.8608|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.8608
91539509|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0283|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0283
91539510|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.0369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0369
91539511|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4606|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.4606
91539512|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.0832|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.0832
91539513|NCT00922207|182957463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2655|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.2655
91539514|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0649|TWO_SIDED|95.0|-0.01|0.43|||ANCOVA|||Baseline||0.43|-0.01|0.0649
91539515|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1867|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||Baseline||0.33|-0.06|0.1867
91539516|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.5003|TWO_SIDED|95.0|-0.3|0.15|||ANCOVA|||Baseline||0.15|-0.30|0.5003
91539517|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.2259|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 4||0.05|-0.22|0.2259
91539518|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4||-0.11|-0.36|<0.001
91539519|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.0085|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Change at Week 4||-0.04|-0.27|0.0085
91539520|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.816|TWO_SIDED|95.0|-0.22|0.18|||ANCOVA|||Change at Week 8||0.18|-0.22|0.8160
91539521|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.4393|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Change at Week 8||0.12|-0.27|0.4393
91539522|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.489|TWO_SIDED|95.0|-0.22|0.11|||ANCOVA|||Change at Week 8||0.11|-0.22|0.4890
91539523|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.4656|TWO_SIDED|95.0|-0.14|0.3|||ANCOVA|||Change at Week 16||0.30|-0.14|0.4656
91539524|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.5016|TWO_SIDED|95.0|-0.15|0.31|||ANCOVA|||Change at Week 16||0.31|-0.15|0.5016
91539525|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.9582|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Change at Week 16||0.22|-0.23|0.9582
91539526|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.6214|TWO_SIDED|95.0|-0.21|0.36|||ANCOVA|||Change at Week 28||0.36|-0.21|0.6214
91539527|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.5493|TWO_SIDED|95.0|-0.21|0.39|||ANCOVA|||Change at Week 28||0.39|-0.21|0.5493
91539528|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.8881|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 28||0.32|-0.28|0.8881
91539529|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7912|TWO_SIDED|95.0|-0.36|0.27|||ANCOVA|||Change at Week 40||0.27|-0.36|0.7912
91539530|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.5427|TWO_SIDED|95.0|-0.24|0.46|||ANCOVA|||Change at Week 40||0.46|-0.24|0.5427
91539531|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3788|TWO_SIDED|95.0|-0.19|0.49|||ANCOVA|||Change at Week 40||0.49|-0.19|0.3788
91539532|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.6172|TWO_SIDED|95.0|-0.44|0.26|||ANCOVA|||Change at Week 52||0.26|-0.44|0.6172
91539533|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6002|TWO_SIDED|95.0|-0.29|0.5|||ANCOVA|||Change at Week 52||0.50|-0.29|0.6002
91539534|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.3101|TWO_SIDED|95.0|-0.18|0.56|||ANCOVA|||Change at Week 52||0.56|-0.18|0.3101
91539535|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.4256|TWO_SIDED|95.0|-0.47|0.2|||ANCOVA|||Change at Week 64||0.20|-0.47|0.4256
91539536|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.9762|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||Change at Week 64||0.36|-0.35|0.9762
91539537|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.4504|TWO_SIDED|95.0|-0.21|0.47|||ANCOVA|||Change at Week 64||0.47|-0.21|0.4504
91539538|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.4076|TWO_SIDED|95.0|-0.42|0.17|||ANCOVA|||Change at Week 76||0.17|-0.42|0.4076
91539539|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7591|TWO_SIDED|95.0|-0.37|0.27|||ANCOVA|||Change at Week 76||0.27|-0.37|0.7591
91539540|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.6449|TWO_SIDED|95.0|-0.25|0.4|||ANCOVA|||Change at Week 76||0.40|-0.25|0.6449
91539541|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.7108|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||Change at Week 88||0.25|-0.36|0.7108
91539542|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.4725|TWO_SIDED|95.0|-0.22|0.47|||ANCOVA|||Change at Week 88||0.47|-0.22|0.4725
91539543|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.2439|TWO_SIDED|95.0|-0.13|0.5|||ANCOVA|||Change at Week 88||0.50|-0.13|0.2439
91539544|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.1862|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Change at Week 100||0.50|-0.10|0.1862
91539545|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3057|TWO_SIDED|95.0|-0.14|0.43|||ANCOVA|||Change at Week 100||0.43|-0.14|0.3057
91539546|NCT00922207|182957464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.8002|TWO_SIDED|95.0|-0.38|0.29|||ANCOVA|||Change at Week 100||0.29|-0.38|0.8002
91539547|NCT02476890|182957466|OTHER||Mean Difference (Final Values)|0.01||||0.9666|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||C2 Response/Healthy||0.7|-0.6|0.9666
91539548|NCT02476890|182957466|OTHER||Mean Difference (Final Values)|-0.22||||0.5993|TWO_SIDED|95.0|-1.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-1.1|0.5993
91539549|NCT02476890|182957466|OTHER||Mean Difference (Final Values)|0.32||||0.2823|TWO_SIDED|95.0|-0.3|0.9|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.9|-0.3|0.2823
91539550|NCT02476890|182957466|OTHER||Mean Difference (Final Values)|0.25||||0.4287|TWO_SIDED|95.0|-0.4|0.9|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.9|-0.4|0.4287
91539551|NCT02476890|182957467|OTHER||Mean Difference (Final Values)|0.56||||0.1771|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||C2 Response/Healthy||1.4|-0.3|0.1771
91539552|NCT02476890|182957467|OTHER||Mean Difference (Final Values)|0.3||||0.5473|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||C5 Response/Healthy||1.3|-0.7|0.5473
91539553|NCT02476890|182957467|OTHER||Mean Difference (Final Values)|0.23||||0.5169|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||C2 Response/Chronic Cough||1.0|-0.5|0.5169
91539554|NCT02476890|182957467|OTHER||Mean Difference (Final Values)|0.28||||0.4243|TWO_SIDED|95.0|-0.4|1.0|||Mixed Models Analysis|||C5 Response/Chronic Cough||1.0|-0.4|0.4243
91539555|NCT02476890|182957468|OTHER||Mean Difference (Final Values)|0.89||||0.1125|TWO_SIDED|95.0|-0.2|2.0|||Mixed Models Analysis|||C2 Response/Healthy||2.0|-0.2|0.1125
91539556|NCT02476890|182957468|OTHER||Mean Difference (Final Values)|0.88||||0.0029|TWO_SIDED|95.0|0.4|1.4|||Mixed Models Analysis|||C5 Response/Healthy||1.4|0.4|0.0029
91539557|NCT02476890|182957468|OTHER||Mean Difference (Final Values)|1.54||||0.0006|TWO_SIDED|95.0|0.7|2.4|||Mixed Models Analysis|||C2 Response/Chronic Cough||2.4|0.7|0.0006
91539558|NCT02476890|182957468|OTHER||Mean Difference (Final Values)|1.3||||0.0067|TWO_SIDED|95.0|0.4|2.2|||Mixed Models Analysis|||C5 Response/Chronic Cough||2.2|0.4|0.0067
91539559|NCT02476890|182957469|OTHER||Mean Difference (Final Values)|0.38|||<|0.0001|TWO_SIDED|95.0|0.2|0.5|||Mixed Models Analysis|||C2 Response/Healthy||0.5|0.2|< 0.0001
91539560|NCT02476890|182957469|OTHER||Mean Difference (Final Values)|0.23||||0.1798|TWO_SIDED|95.0|-0.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-0.1|0.1798
91539561|NCT02476890|182957469|OTHER||Mean Difference (Final Values)|0.3||||0.0011|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.5|0.1|0.0011
91539562|NCT02476890|182957469|OTHER||Mean Difference (Final Values)|0.28||||0.0023|TWO_SIDED|95.0|0.1|0.4|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.4|0.1|0.0023
91539563|NCT02476890|182957470|OTHER||Mean Difference (Final Values)|-18.0||||0.0037|TWO_SIDED|95.0|-29.8|-6.2|||Mixed Models Analysis|||Cough Severity VAS Analysis||-6.2|-29.8|0.0037
91539564|NCT02476890|182957471|OTHER||Mean Difference (Final Values)|-18.0||||0.002|TWO_SIDED|95.0|-29.1|-7.0|||Mixed Models Analysis|||Urge to Cough VAS Analysis||-7.0|-29.1|0.0020
91539565|NCT02476890|182957472|OTHER||Mean Difference (Final Values)|-3.6||||0.0075|TWO_SIDED|95.0|-6.2|-1.0|||Mixed Models Analysis|||Cough Frequency Analysis||-1.0|-6.2|0.0075
91539566|NCT03515304|182957489|SUPERIORITY|||||||0.2497|||||||t-test, 2 sided|||||||0.2497
91539567|NCT03684265|182957513|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|92.74|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|95.0|89.02|96.62|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-t. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||96.62|89.02|
91539568|NCT03684265|182957514|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|78.94|STANDARD_ERROR_OF_MEAN|14.57|||TWO_SIDED|90.0|73.7|84.56|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for Cmax. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||84.56|73.70|
91539569|NCT03684265|182957515|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|97.04|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|92.57|101.72|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-∞. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||101.72|92.57|
91539570|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.||1.31|0.81|
91539571|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.8|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3||1.16|0.8|
91539572|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.13|||||TWO_SIDED|95.0|0.92|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4||1.4|0.92|
91539573|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.75|1.21|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5||1.21|0.75|
91539574|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.92|||||TWO_SIDED|95.0|0.73|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B||1.16|0.73|
91539575|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F||1.29|0.89|
91539576|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.79|1.19|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V||1.19|0.79|
91539577|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.18|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14||1.18|0.81|
91539578|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.95|||||TWO_SIDED|95.0|0.77|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C||1.16|0.77|
91539579|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.15|||||TWO_SIDED|95.0|0.95|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A||1.4|0.95|
91539580|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.84|1.25|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F||1.25|0.84|
91539581|NCT02045836|182957521|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.89|||||TWO_SIDED|95.0|0.7|1.12|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F||1.12|0.7|
91539582|NCT02045836|182957522|NON_INFERIORITY|Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5|Adjusted GMC|1.02|||||TWO_SIDED|95.0|0.93|1.11|||ANCOVA|Ancova model: adjustment for baseline concentration and age - pooled variance|Adjusted ratios of GMCs between groups (Control group and Co-Ad group)|Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations||1.11|0.93|
91539583|NCT02974634|182957543|SUPERIORITY||Slope|1.04|STANDARD_ERROR_OF_MEAN|2.32||0.06|TWO_SIDED|95.0|-3.5|5.6||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||5.6|-3.5|0.06
91539584|NCT02974634|182957544|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.68|TWO_SIDED|95.0|-0.24|0.91||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||0.91|-0.24|0.68
91539585|NCT05011396|182957545|SUPERIORITY||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|2.36||0.0153|TWO_SIDED|95.0|-10.5|-1.1|||ANCOVA|||||-1.1|-10.5|0.0153
91539586|NCT05011396|182957546|SUPERIORITY||Other|0.1625||||0.033|TWO_SIDED|95.0|0.0132|0.3119|||Wald Normal Approximation (Z)|||||0.3119|0.0132|0.0330
91539587|NCT03622593|182957594|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-0.1|3.2|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|
91539588|NCT03622593|182957594|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-1.1|2.1|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|
91539589|NCT03622593|182957594|SUPERIORITY||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1718|TWO_SIDED|97.5|-0.7|3.0||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||3.0|-0.7|0.1718
91539590|NCT03622593|182957594|SUPERIORITY||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4602|TWO_SIDED|97.5|-1.2|2.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.4|-1.2|0.4602
91539591|NCT03622593|182957594|SUPERIORITY||Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73||0.0361|TWO_SIDED|97.5|-0.1|3.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|0.0361
91539592|NCT03622593|182957594|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73||0.493|TWO_SIDED|97.5|-1.1|2.1||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|0.4930
91539593|NCT03622593|182957595|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab Q8W and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab Q8W was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|97.5|-12.6|7.4||||||This analysis is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|
91539594|NCT03622593|182957595|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab PTI and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab PTI was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|97.5|-13.4|6.3||||||This analysis is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|
91539595|NCT03622593|182957595|SUPERIORITY||Difference in CMH Weighted Percentage|-5.4||||0.3009|TWO_SIDED|97.5|-16.9|6.1||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||6.1|-16.9|0.3009
91539596|NCT03622593|182957595|SUPERIORITY||Difference in CMH Weighted Percentage|-6.9||||0.1735|TWO_SIDED|97.5|-18.3|4.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||4.4|-18.3|0.1735
91539597|NCT03622593|182957595|SUPERIORITY||Difference in CMH Weighted Percentage|-2.6||||0.5757|TWO_SIDED|97.5|-12.6|7.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|0.5757
91539598|NCT03622593|182957595|SUPERIORITY||Difference in CMH Weighted Percentage|-3.5||||0.4293|TWO_SIDED|97.5|-13.4|6.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|0.4293
91539599|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
91539600|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-9.1|5.2||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-9.1|
91539601|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.5|13.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||13.4|-2.5|
91539602|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.9|6.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.8|-8.9|
91539603|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|3.8|||||TWO_SIDED|95.0|-2.7|10.3||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||10.3|-2.7|
91539604|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-7.3|5.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.9|-7.3|
91539605|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-3.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-3.8|
91539606|NCT03622593|182957598|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-4.9|4.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.2|-4.9|
91539607|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-8.5|8.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.9|-8.5|
91539608|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|95.0|-11.8|4.8||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.8|-11.8|
91539609|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|2.2|||||TWO_SIDED|95.0|-6.9|11.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.4|-6.9|
91539610|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.1|-9.8|
91539611|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.2|8.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.5|-6.2|
91539612|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.3|6.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.2|-8.3|
91539613|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-3.8|6.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||6.2|-3.8|
91539614|NCT03622593|182957603|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-4.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-4.8|
91539615|NCT03622593|182957608|OTHER||Difference in CMH Weighted Percentage|0.3|||||TWO_SIDED|95.0|-1.6|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-1.6|
91539616|NCT03622593|182957608|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-1.8|
91539617|NCT03622593|182957608|OTHER||Difference in CMH Weighted Percentage|-0.1|||||TWO_SIDED|95.0|-2.3|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-2.3|
91539618|NCT03622593|182957608|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.4|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-2.4|
91539619|NCT03622593|182957608|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-1.9|4.5||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.5|-1.9|
91539620|NCT03622593|182957608|OTHER||Difference in CMH Weighted Percentage|1.6|||||TWO_SIDED|95.0|-1.5|4.6||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.6|-1.5|
91539621|NCT03622593|182957612|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.3|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.3|
91539622|NCT03622593|182957612|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-2.0|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.0|
91539623|NCT03622593|182957612|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.7|2.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.6|-2.7|
91539624|NCT03622593|182957612|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.3|-2.9|
91539625|NCT03622593|182957612|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.0|4.7||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.7|-2.0|
91539626|NCT03622593|182957612|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-2.1|4.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.4|-2.1|
91539627|NCT03622593|182957616|OTHER||Difference in CMH Weighted Percentage|4.8|||||TWO_SIDED|95.0|-3.1|12.7||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||12.7|-3.1|
91539628|NCT03622593|182957616|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||6.2|-8.8|
91539629|NCT03622593|182957616|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-6.5|11.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||11.6|-6.5|
91539630|NCT03622593|182957616|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-10.0|7.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||7.4|-10.0|
91539631|NCT03622593|182957619|OTHER||Difference in CMH Weighted Percentage|4.7|||||TWO_SIDED|95.0|-2.4|11.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||11.8|-2.4|
91539632|NCT03622593|182957619|OTHER||Difference in CMH Weighted Percentage|2.8|||||TWO_SIDED|95.0|-4.1|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-4.1|
91539633|NCT03622593|182957619|OTHER||Difference in CMH Weighted Percentage|1.5|||||TWO_SIDED|95.0|-6.5|9.4||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.4|-6.5|
91539634|NCT03622593|182957619|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-6.0|9.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.3|-6.0|
91539635|NCT03622593|182957622|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-1.4|1.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.5|-1.4|
91539636|NCT03622593|182957622|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-1.6|0.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.2|-1.6|
91539637|NCT03622593|182957622|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.1|2.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.1|-1.1|
91539638|NCT03622593|182957622|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.4|-1.4|
91539639|NCT03622593|182957631|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.8|-1.0|
91539640|NCT03622593|182957631|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.0|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.0|
91539641|NCT03622593|182957631|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-0.6|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||1.8|-0.6|
91539642|NCT03622593|182957631|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-0.4|2.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.8|-0.4|
91539643|NCT03622593|182957632|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
91539644|NCT03622593|182957632|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
91539645|NCT03622593|182957632|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
91539646|NCT03622593|182957632|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
91539647|NCT03622593|182957639|OTHER||Adjusted mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-37.4|-14.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.0|-37.4|
91539648|NCT03622593|182957639|OTHER||Adjusted mean difference|-17.6|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-29.2|-6.0||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-6.0|-29.2|
91539649|NCT03622593|182957639|OTHER||Adjusted mean difference|-20.0|STANDARD_ERROR_OF_MEAN|6.59|||TWO_SIDED|95.0|-32.9|-7.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-7.0|-32.9|
91539650|NCT03622593|182957639|OTHER||Adjusted mean difference|-14.3|STANDARD_ERROR_OF_MEAN|6.51|||TWO_SIDED|95.0|-27.1|-1.5||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-1.5|-27.1|
91539651|NCT03622593|182957642|OTHER||Difference in CMH Weighted Percentage|12.3|||||TWO_SIDED|95.0|5.7|18.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||18.9|5.7|
91539652|NCT03622593|182957642|OTHER||Difference in CMH Weighted Percentage|8.2|||||TWO_SIDED|95.0|1.5|14.9||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||14.9|1.5|
91539653|NCT03622593|182957642|OTHER||Difference in CMH Weighted Percentage|9.0|||||TWO_SIDED|95.0|1.6|16.3||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||16.3|1.6|
91539654|NCT03622593|182957642|OTHER||Difference in CMH Weighted Percentage|6.2|||||TWO_SIDED|95.0|-1.2|13.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||13.6|-1.2|
91539655|NCT01324453|182957717|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||||||0.90
91539656|NCT01324453|182957718|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||0.81
91539657|NCT01324453|182957719|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
91539658|NCT01324453|182957720|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91539659|NCT01324453|182957721|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||||||0.86
91539660|NCT01324453|182957722|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.00
91539661|NCT01324453|182957723|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
91539662|NCT01324453|182957724|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
91539663|NCT01499134|182957725|SUPERIORITY_OR_OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91539664|NCT01499134|182957726|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
91539665|NCT01499134|182957727|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||This p-value is correct, confirmed with report from statistician.|Wilcoxon (Mann-Whitney)|||||||1.000
91539666|NCT01499134|182957728|SUPERIORITY_OR_OTHER|||||||0.363|||||||Wilcoxon (Mann-Whitney)|||||||0.363
91539667|NCT01499134|182957729|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
91539668|NCT01499134|182957730|SUPERIORITY_OR_OTHER|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||||||0.476
91539669|NCT01499134|182957731|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.170
91539670|NCT01499134|182957732|SUPERIORITY_OR_OTHER|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||||||0.595
91539671|NCT03557658|182957760|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate|106.22|||||TWO_SIDED|90.0|78.34|144.02|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group.||144.02|78.34|
91539672|NCT03557658|182957760|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|110.84|||||TWO_SIDED|90.0|75.34|163.06|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||163.06|75.34|
91539673|NCT03557658|182957763|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|128.34|||||TWO_SIDED|90.0|99.98|164.73|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group||164.73|99.98|
91539674|NCT03557658|182957763|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|132.16|||||TWO_SIDED|90.0|96.46|181.08|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||181.08|96.46|
91539675|NCT01194154|182957765|SUPERIORITY_OR_OTHER||treatment effect|2.21||||0.657|TWO_SIDED|95.0|-0.35|4.78|||Wilcoxon (Mann-Whitney)||An analysis of covariance (ANCOVA) model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||4.78|-0.35|0.657
91539676|NCT01194154|182957766|SUPERIORITY_OR_OTHER||treatment effect|2.24||||0.709|TWO_SIDED|95.0|-0.54|5.01|||Wilcoxon (Mann-Whitney)||ANCOVA model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||5.01|-0.54|0.709
91539677|NCT01901276|182957776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||t-test, 2 sided|||Within-individual differences in Shannon indices were tested using paired t tests (normally distributed data).||||0.71
91539678|NCT02314117|182957777|SUPERIORITY||Hazard Ratio (HR)|0.753|||||TWO_SIDED|95.0|0.607|0.935||||||||0.935|0.607|
91539679|NCT02314117|182957778|SUPERIORITY||Hazard Ratio (HR)|0.962|||||TWO_SIDED|95.0|0.801|1.156||||||||1.156|0.801|
91539680|NCT02314117|182957779|SUPERIORITY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.774|1.108||||||||1.108|0.774|
91539681|NCT02314117|182957782|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.569|0.859||||||||0.859|0.569|
91539682|NCT02314117|182957783|SUPERIORITY||Hazard Ratio (HR)|0.657|||||TWO_SIDED|95.0|0.499|0.866||||||||0.866|0.499|
91539683|NCT02314117|182957784|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.77|1.332||||||||1.332|0.770|
91539684|NCT02314117|182957786|SUPERIORITY||Hazard Ratio (HR)|1.117|||||TWO_SIDED|95.0|0.79|1.58||||||||1.580|0.790|
91539685|NCT00367055|182957838|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p value is for Total AUC(0-10 min)|Van Elteren|||||||0.376
91539686|NCT00367055|182957838|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||p value is for Incremental AUC(0-10 min)|Van Elteren|||||||0.990
91539687|NCT01215695|182957880|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91539688|NCT01215695|182957881|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91539689|NCT01215695|182957882|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91539690|NCT01215695|182957883|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91539691|NCT01215695|182957884|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91539692|NCT01378065|182957907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91539693|NCT01378065|182957908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91539694|NCT01378065|182957909|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91539695|NCT01378065|182957910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91539696|NCT01378065|182957911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||t-test, 2 sided|||||||0.202
91539697|NCT01378065|182957912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91539698|NCT01378065|182957913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
91539699|NCT01378065|182957914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED||||||t-test, 2 sided|||||||0.034
91539700|NCT01378065|182957915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 weeks.||||0.001
91539701|NCT01378065|182957916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 3 months.||||0.004
91539702|NCT01378065|182957917|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 months.||||<.001
91539703|NCT01378065|182957918|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 12 months.||||<.001
91539704|NCT00361283|182957919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-111.0|STANDARD_ERROR_OF_MEAN|76.7||0.15|TWO_SIDED|95.0|-264.0|42.0||No confounders were controlled for as each person is his/her own control.|t-test, 2 sided|||The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.||42|-264|0.15
91539705|NCT01123083|182958014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.051|TWO_SIDED|95.0|-0.17|0.0|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|||0.00|-0.17|0.051
91539706|NCT01123083|182958015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.022|TWO_SIDED|95.0|-0.18|-0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Week 12||-0.02|-0.18|0.022
91539707|NCT01123083|182958015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.191|TWO_SIDED|95.0|-0.15|0.03|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.03|-0.15|0.191
91539708|NCT01123083|182958017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.912|TWO_SIDED|95.0|0.5|3.37|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Week 12||3.37|0.50|0.912
91539709|NCT01123083|182958017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.912|TWO_SIDED|95.0|0.37|2.42|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 6||2.42|0.37|0.912
91539710|NCT01123083|182958017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.412|TWO_SIDED|95.0|0.54|4.52|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 12||4.52|0.54|0.412
91539711|NCT01123083|182958018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.21|TWO_SIDED|95.0|-0.08|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.02|-0.08|0.210
91539712|NCT01123083|182958018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.21|TWO_SIDED|95.0|-0.11|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.02|-0.11|0.210
91539713|NCT01123083|182958018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.402|TWO_SIDED|95.0|-0.05|0.13|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.13|-0.05|0.402
91539714|NCT01123083|182958019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.582|TWO_SIDED|95.0|-0.52|0.16|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.16|-0.52|0.582
91539715|NCT01123083|182958019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.46|0.45|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.45|-0.46|0.987
91539716|NCT01123083|182958019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.572|TWO_SIDED|95.0|-0.33|0.59|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.59|-0.33|0.572
91539717|NCT01123083|182958022|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 6||||0.452
91539718|NCT01123083|182958022|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 12||||0.452
91539719|NCT01123083|182958023|SUPERIORITY_OR_OTHER|||||||0.123|||||||Hochberg-adjusted p-value|||Month 6||||0.123
91539720|NCT01123083|182958023|SUPERIORITY_OR_OTHER|||||||0.373|||||||Hochberg-adjusted p-value|||Month 12||||0.373
91539721|NCT00961636|182958024|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test was stratified by country||||||<0.001
91539722|NCT00961636|182958025|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Unconditional Miettinen and Nurminen|||||||<0.001
91539723|NCT00688519|182958041|SUPERIORITY_OR_OTHER|||||||0.058|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.058
91539724|NCT00688519|182958041|SUPERIORITY_OR_OTHER|||||||0.313|||||||Breslow-Day Test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.313
91539725|NCT00688519|182958042|SUPERIORITY_OR_OTHER|||||||0.029|||||||Cochran-Mantel-Haenszel|||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.029
91763583|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
91763584|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.3|||||TWO_SIDED|95.0|-1.1|6.3||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||6.3|-1.1|
91763585|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.9|-4.2|
91539726|NCT00688519|182958043|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.013
91539727|NCT00688519|182958044|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.008
91539728|NCT00688519|182958045|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.018
91539729|NCT00688519|182958046|SUPERIORITY_OR_OTHER|||||||0.167|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.167
91539730|NCT00688519|182958046|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.009
91539731|NCT00430300|182958068|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0087||||0.0284|TWO_SIDED|95.0|-0.0943|0.0774|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0774|-0.0943|0.0284
91539732|NCT00430300|182958068|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0389||||0.0056|TWO_SIDED|95.0|-0.1299|0.0471|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0471|-0.1299|0.0056
91539733|NCT00430300|182958068|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.051||||0.0009|TWO_SIDED|95.0|-0.1298|0.029|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0290|-0.1298|0.0009
91539734|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5849|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5849
91763586|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
91539735|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.9737|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.9737
91539736|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.387|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.3870
91539737|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.8612|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.8612
91539738|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.7499|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.7499
91539739|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5134|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5134
91539740|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.1244|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.1244
91539741|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.53|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.5300
91539742|NCT00430300|182958069|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.055|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0550
91539743|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.7444|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.7444
91539744|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.9134|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.9134
91539745|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6841|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6841
91763587|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
91763588|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
91539746|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.9283|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.9283
91539747|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.2991|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.2991
91539748|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.7403|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.7403
91539749|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.3499|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.3499
91539750|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.2734|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2734
91539751|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.5806|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.5806
91539752|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.11||0.054|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0540
91539753|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2616|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.2616
91539754|NCT00430300|182958070|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.0724|ONE_SIDED|95.0|-0.02||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.02|0.0724
91539755|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.9362|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.9362
91539756|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.9469|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.9469
91539757|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.9153|ONE_SIDED|95.0|-0.27||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.27|0.9153
91539758|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.9686|ONE_SIDED|95.0|-0.36||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.36|0.9686
91539759|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1548|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1548
91539760|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.7973|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.7973
91539761|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6348|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.6348
91539762|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.5742|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.5742
91539763|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6719|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.6719
91539764|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.0881|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.0881
91539765|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.2772|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2772
91539766|NCT00430300|182958071|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.11||0.1363|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1363
91539767|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0938|ONE_SIDED|95.0|-0.03||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.03|0.0938
91539768|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.2149|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2149
91539769|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.09||0.1682|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1682
91539770|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.1||0.4492|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.4492
91539771|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2539|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.2539
91539772|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.8168|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.8168
91539773|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3248|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3248
91539774|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3148|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3148
91539775|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6563|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.6563
91539776|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.1735|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1735
91539777|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.1237|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1237
91539778|NCT00430300|182958072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.6113|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.6113
91539779|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5549|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5549
91539780|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.988|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.9880
91539781|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.8572|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.8572
91539782|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.8402|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.8402
91539783|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6562|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.6562
91539784|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.5632|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5632
91539785|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.637|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6370
91539786|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.4686|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.4686
91539787|NCT00430300|182958073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.6164|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.6164
91539788|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.9885|ONE_SIDED|95.0|-2.4||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.4|0.9885
91539789|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.8055|ONE_SIDED|95.0|-1.5||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.5|0.8055
91539790|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.5||0.9759|ONE_SIDED|95.0|-2.0||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.0|0.9759
91539791|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.4401|ONE_SIDED|95.0|-1.1||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.1|0.4401
91539792|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.5957|ONE_SIDED|95.0|-1.4||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.4|0.5957
91539793|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.8302|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.8302
91539794|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.9657|ONE_SIDED|95.0|-3.1||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-3.1|0.9657
91539795|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.6378|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.6378
91539796|NCT00430300|182958081|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.899|ONE_SIDED|95.0|-2.2||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.2|0.8990
91539797|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.15||0.8757|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8757
91539798|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6334|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6334
91539799|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.5448|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.5448
91539800|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.6986|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6986
91539801|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.3151|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.3151
91539802|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.1802|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.1802
91539803|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.9102|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9102
91539804|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.6391|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6391
91539805|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6838|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6838
91539806|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9648|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9648
91539807|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.8961|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.8961
91539808|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.9534|ONE_SIDED|95.0|-0.41||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.41|0.9534
91539809|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.7726|ONE_SIDED|95.0|-0.45||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.45|0.7726
91539810|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.18||0.5665|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.5665
91539811|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2684|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2684
91539812|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.6485|ONE_SIDED|95.0|-0.39||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.39|0.6485
91539813|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.4821|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.4821
91763589|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|1.7|||||TWO_SIDED|95.0|-1.9|5.8||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||5.8|-1.9|
91763590|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
91539814|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.2557|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2557
91539815|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.9031|ONE_SIDED|95.0|-0.52||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.52|0.9031
91539816|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.8634|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.8634
91539817|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6375|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6375
91539818|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.8775|ONE_SIDED|95.0|-0.51||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.51|0.8775
91539819|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.7191|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.7191
91539820|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.8677|ONE_SIDED|95.0|-0.44||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.44|0.8677
91539821|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.9838|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.9838
91539822|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.8106|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.8106
91539823|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.775|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.7750
91539824|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.8082|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.8082
91539825|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.7678|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7678
91539826|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.5373|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.5373
91539827|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.9548|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9548
91539828|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9743|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9743
91539829|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.8408|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.8408
91539830|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.9887|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9887
91539831|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.13||0.9918|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9918
91539832|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.9833|ONE_SIDED|95.0|-0.46||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.46|0.9833
91539833|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9619|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9619
91539834|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.9917|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.9917
91539835|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.9376|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.9376
91539836|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.9084|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9084
91539837|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.15||0.7906|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7906
91539838|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.8765|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8765
91539839|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.8469|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8469
91539840|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9717|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9717
91539841|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.7591|ONE_SIDED|95.0|-0.29||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.29|0.7591
91539842|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.7141|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7141
91539843|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.8104|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8104
91539844|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.7664|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7664
91539845|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.7888|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7888
91539846|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.393|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3930
91539847|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.4785|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.4785
91539848|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6756|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6756
91763591|NCT01200368|183417655|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|1.0|7.3||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|1.0|
91539849|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2627|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2627
91539850|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2281|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2281
91539851|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.7656|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7656
91539852|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.16||0.2105|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2105
91539853|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2221|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2221
91539854|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.4396|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.4396
91539855|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.15||0.2243|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2243
91539856|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.3597|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3597
91539857|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.203|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2030
91763592|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.94|0.71|
91763593|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.97|0.64|
91539858|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.1207|ONE_SIDED|95.0|-0.07||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.07|0.1207
91539859|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.1836|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1836
91539860|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17||0.2359|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.2359
91763594|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.74|||||TWO_SIDED|95.0|0.64|0.86||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.86|0.64|
91763595|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.70|
91763596|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.85|0.63|
91763597|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.08|0.72|
91763598|NCT01200368|183417656|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.66|
91763599|NCT01200368|183417657|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
91763600|NCT01200368|183417657|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.2|-2.1|
91763601|NCT01200368|183417657|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
91763602|NCT01200368|183417657|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
91763603|NCT01200368|183417658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.8|||||TWO_SIDED|95.0|1.5|2.15||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.15|1.50|
91763604|NCT01200368|183417658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.28|0.92|
91763605|NCT01200368|183417658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.86|1.22||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.22|0.86|
91763606|NCT01200368|183417658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.25|0.87|
91763607|NCT01200368|183417658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.83|||||TWO_SIDED|95.0|1.54|2.16||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.16|1.54|
91763608|NCT01200368|183417658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.89|||||TWO_SIDED|95.0|1.59|2.25||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.25|1.59|
91763609|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
91539861|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.2861|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.2861
91539862|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.2151|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2151
91539863|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.3545|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.3545
91539864|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.7102|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7102
91539865|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.3883|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.3883
91539866|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.2228|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2228
91539867|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.6342|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6342
91539868|NCT00430300|182958082|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.3141|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.3141
91539869|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.27||0.27|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.2700
91539870|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.26||0.1831|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.1831
91539871|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.23||0.1796|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.1796
91539872|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.8136|ONE_SIDED|95.0|-0.79||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.79|0.8136
91763610|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
91539873|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6877|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.6877
91539874|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.6382|ONE_SIDED|95.0|-0.54||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.54|0.6382
91539875|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.36||0.766|ONE_SIDED|95.0|-0.87||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.87|0.7660
91539876|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.7226|ONE_SIDED|95.0|-0.8||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.80|0.7226
91539877|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.31||0.6634|ONE_SIDED|95.0|-0.65||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.65|0.6634
91539878|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.35||0.7598|ONE_SIDED|95.0|-0.83||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.83|0.7598
91763611|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
91539879|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.34||0.53|ONE_SIDED|95.0|-0.59||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.59|0.5300
91539880|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.3||0.7054|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.7054
91539881|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.45||0.8851|ONE_SIDED|95.0|-1.3||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.30|0.8851
91539882|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.7575|ONE_SIDED|95.0|-1.05||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.05|0.7575
91539883|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.39||0.4325|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.4325
91539884|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.8934|ONE_SIDED|95.0|-1.41||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.41|0.8934
91539885|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.47||0.5283|ONE_SIDED|95.0|-0.82||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.82|0.5283
91539886|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.41||0.49|ONE_SIDED|95.0|-0.68||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.68|0.4900
91539887|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.7465|ONE_SIDED|95.0|-1.2||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.20|0.7465
91539888|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.51||0.5848|ONE_SIDED|95.0|-0.95||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.95|0.5848
91539889|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.44||0.3178|ONE_SIDED|95.0|-0.53||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.53|0.3178
91539890|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.8169|ONE_SIDED|95.0|-1.34||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.34|0.8169
91539891|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.51||0.6727|ONE_SIDED|95.0|-1.08||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.08|0.6727
91539892|NCT00430300|182958083|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.5014|ONE_SIDED|95.0|-0.75||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.75|0.5014
91539893|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.3||0.7292|ONE_SIDED|95.0|-14.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-14.3|0.7292
91539894|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|6.2||0.2768|ONE_SIDED|95.0|-6.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-6.6|0.2768
91539895|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.4||0.3795|ONE_SIDED|95.0|-7.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-7.4|0.3795
91539896|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|7.7||0.7374|ONE_SIDED|95.0|-17.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.7|0.7374
91539897|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.6||0.7615|ONE_SIDED|95.0|-18.1||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.1|0.7615
91539898|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|6.6||0.5811|ONE_SIDED|95.0|-12.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.4|0.5811
91539899|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.6||0.8939|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.8939
91539900|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4||0.8117|ONE_SIDED|95.0|-21.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.6|0.8117
91539901|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|7.4||0.4393|ONE_SIDED|95.0|-11.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.2|0.4393
91539902|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|9.8||0.8055|ONE_SIDED|95.0|-24.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.7|0.8055
91539903|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.5||0.6767|ONE_SIDED|95.0|-20.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-20.2|0.6767
91539904|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4||0.407|ONE_SIDED|95.0|-12.0||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.0|0.4070
91539905|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|9.7||0.9705|ONE_SIDED|95.0|-34.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-34.7|0.9705
91539906|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|9.4||0.8249|ONE_SIDED|95.0|-24.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.6|0.8249
91539907|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|8.3||0.9345|ONE_SIDED|95.0|-26.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.6|0.9345
91539908|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|11.0||0.7384|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.7384
91539909|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|10.7||0.5239|ONE_SIDED|95.0|-18.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.4|0.5239
91539910|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|9.4||0.417|ONE_SIDED|95.0|-13.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.7|0.4170
91539911|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|10.3||0.7695|ONE_SIDED|95.0|-24.8||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.8|0.7695
91539912|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|10.1||0.4566|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4566
91539913|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|8.9||0.3535|ONE_SIDED|95.0|-11.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.4|0.3535
91539914|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|11.1||0.8598|ONE_SIDED|95.0|-30.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.7|0.8598
91539915|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|10.9||0.8005|ONE_SIDED|95.0|-27.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.4|0.8005
91539916|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|9.6||0.3441|ONE_SIDED|95.0|-12.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.2|0.3441
91539917|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|6.9||0.4436|ONE_SIDED|95.0|-10.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-10.5|0.4436
91539918|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.8||0.7238|ONE_SIDED|95.0|-15.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.5|0.7238
91539919|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|6.0||0.5743|ONE_SIDED|95.0|-11.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.1|0.5743
91539920|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|9.8||0.619|ONE_SIDED|95.0|-19.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.3|0.6190
91539921|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|9.7||0.9473|ONE_SIDED|95.0|-32.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.1|0.9473
91539922|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|8.5||0.8014|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.8014
91539923|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|8.6||0.7929|ONE_SIDED|95.0|-21.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.5|0.7929
91539924|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|8.4||0.9963|ONE_SIDED|95.0|-37.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-37.3|0.9963
91539925|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|7.4||0.7387|ONE_SIDED|95.0|-17.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.1|0.7387
91539926|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.4||0.6286|ONE_SIDED|95.0|-16.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.8|0.6286
91539927|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|8.3||0.9538|ONE_SIDED|95.0|-27.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.8|0.9538
91539928|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.3||0.5701|ONE_SIDED|95.0|-13.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.4|0.5701
91539929|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|10.0||0.9242|ONE_SIDED|95.0|-31.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-31.3|0.9242
91539930|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.8||0.9876|ONE_SIDED|95.0|-38.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-38.8|0.9876
91539931|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.1|STANDARD_ERROR_OF_MEAN|8.7||0.9802|ONE_SIDED|95.0|-32.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.5|0.9802
91539932|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|10.6||0.5705|ONE_SIDED|95.0|-19.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.5|0.5705
91539933|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|10.3||0.8063|ONE_SIDED|95.0|-26.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.1|0.8063
91539934|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|9.1||0.6667|ONE_SIDED|95.0|-19.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.1|0.6667
91539935|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|10.4||0.464|ONE_SIDED|95.0|-16.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.4|0.4640
91539936|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|10.2||0.8821|ONE_SIDED|95.0|-29.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-29.3|0.8821
91539937|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|9.0||0.7591|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.7591
91539938|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|11.0||0.4001|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4001
91539939|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|10.8||0.8707|ONE_SIDED|95.0|-30.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.3|0.8707
91539940|NCT00430300|182958084|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|9.6||0.4629|ONE_SIDED|95.0|-15.0||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.0|0.4629
91539941|NCT00430300|182958085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6428|||||TWO_SIDED|95.0|0.2023|2.0419||||||A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0419|0.2023|
91539942|NCT00430300|182958085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5574|||||TWO_SIDED|95.0|0.1505|2.0647||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0647|0.1505|
91539943|NCT00430300|182958085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327|||||TWO_SIDED|95.0|0.083|1.2879||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.2879|0.0830|
91539944|NCT00430300|182958086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5709|||||TWO_SIDED|95.0|0.179|1.8204||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.8204|0.1790|
91539945|NCT00430300|182958086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6416|||||TWO_SIDED|95.0|0.1736|2.3715||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.3715|0.1736|
91539946|NCT00430300|182958086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5877|||||TWO_SIDED|95.0|0.1516|2.2777||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.2777|0.1516|
91539947|NCT02666742|182958092|SUPERIORITY|Continuous variables were compared by two-sample t-tests and categorical variables by chi-square test. All tests were two-tailed, and a P value less than 0.05 was considered to indicate statistical significance. Bonferroni correction was not performed due to prespecified outcomes in the trial. Analyses were performed using GraphPad 6||||||0.001|||||||Chi-squared|||Due to lack of precedent robust clinical data, we performed exploratory study to evaluate safety and efficacy of DOAC vs. Aspirin (ASA) in patients undergoing left ventricular arrhythmia (LVA) ablation; therefore, sample size calculation was not undertaken.||||0.001
91539948|NCT01063517|182958121|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|80.0|0.62|1.03|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||1.03|0.62|
91539949|NCT01063517|182958122|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|80.0|0.51|1.08|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||1.08|0.51|
91539950|NCT01063517|182958123|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|80.0|0.41|0.75|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||0.75|0.41|
91763612|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
91539951|NCT01063517|182958124|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|80.0|0.22|0.56|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||0.56|0.22|
91539952|NCT01359371|182958138|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||Bivariate relationships between a patient's participation in the program and smoking status were calculated.||||<.01
91539953|NCT01359371|182958139|OTHER|T-tests, chi squares and Fishers exact tests were used to compare groups.|||||<|0.05||||||This was just a sample description, so there was not adjustment for multiple comparisons.|Chi-squared||||T-tests, chi squares and Fishers exact tests were used to compare groups.|||<.05
91539954|NCT01359371|182958139|OTHER||||||<|0.05|||||||Chi-squared|||T-tests, chi squares and Fishers exact tests were used to compare groups.||||<.05
91539955|NCT01113931|182958280|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.3|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
91539956|NCT01113931|182958283|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.2|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
91539957|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.82|||||TWO_SIDED|95.0|1.27|2.61|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.61|1.27|
91539958|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.57|||||TWO_SIDED|95.0|1.79|3.7|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.70|1.79|
91539959|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.7|||||TWO_SIDED|95.0|1.88|3.88|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.88|1.88|
91539960|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.79|||||TWO_SIDED|95.0|1.29|2.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.50|1.29|
91539961|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.19|||||TWO_SIDED|95.0|1.57|3.05|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.05|1.57|
91539962|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.52|||||TWO_SIDED|95.0|1.81|3.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.50|1.81|
91539963|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.68|||||TWO_SIDED|95.0|0.54|0.87|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.87|0.54|
91539964|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.12|0.69|
91539965|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.06|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.06|0.66|
91539966|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.44|0.86|
91539967|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.54|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.54|0.93|
91539968|NCT04956575|182958338|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.55|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.55|0.93|
91539969|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||1.44|0.57|
91539970|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.25|||||TWO_SIDED|95.0|0.78|2.0|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.00|0.78|
91539971|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.86|||||TWO_SIDED|95.0|1.16|2.99|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against H1N1 at Day 29.||2.99|1.16|
91763613|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
91763614|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-3.9|2.4||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-3.9|
91763615|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
91763616|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
91763617|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
91539972|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.41|||||TWO_SIDED|95.0|0.91|2.21|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.21|0.91|
91539973|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.89|||||TWO_SIDED|95.0|1.21|2.97|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.97|1.21|
91539974|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.64|||||TWO_SIDED|95.0|1.68|4.14|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||4.14|1.68|
91539975|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.36|||||TWO_SIDED|95.0|0.26|0.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.50|0.26|
91763618|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
91539976|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.46|||||TWO_SIDED|95.0|0.33|0.64|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.64|0.33|
91539977|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.76|0.38|
91539978|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.62|||||TWO_SIDED|95.0|0.43|0.9|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||0.90|0.43|
91539979|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.92|||||TWO_SIDED|95.0|0.63|1.35|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.35|0.63|
91539980|NCT04956575|182958339|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.75|||||TWO_SIDED|95.0|0.51|1.09|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.09|0.51|
91539981|NCT04956575|182958342|OTHER||Percent difference|12.61|||||TWO_SIDED|95.0|-2.0|27.93|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||27.93|-2.00|
91763619|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
91763620|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
91539982|NCT04956575|182958342|OTHER||Percent difference|25.17|||||TWO_SIDED|95.0|11.18|39.89|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||39.89|11.18|
91539983|NCT04956575|182958342|OTHER||Percent Difference|26.2|||||TWO_SIDED|95.0|12.33|40.84|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||40.84|12.33|
91539984|NCT04956575|182958342|OTHER||Percent Difference|25.59|||||TWO_SIDED|95.0|9.82|40.13|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.13|9.82|
91539985|NCT04956575|182958342|OTHER||Percent Difference|31.35|||||TWO_SIDED|95.0|15.66|45.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||45.73|15.66|
91539986|NCT04956575|182958342|OTHER||Percent Difference|38.34|||||TWO_SIDED|95.0|22.98|52.3|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||52.30|22.98|
91539987|NCT04956575|182958342|OTHER||Percent Difference|-9.78|||||TWO_SIDED|95.0|-24.83|3.79|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||3.79|-24.83|
91539988|NCT04956575|182958342|OTHER||Percent Difference|0.64|||||TWO_SIDED|95.0|-14.91|14.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||14.73|-14.91|
91539989|NCT04956575|182958342|OTHER||Percent Difference|4.45|||||TWO_SIDED|95.0|-11.19|18.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||18.59|-11.19|
91539990|NCT04956575|182958342|OTHER||Percent Difference|8.97|||||TWO_SIDED|95.0|-6.72|23.09|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||23.09|-6.72|
91539991|NCT04956575|182958342|OTHER||Percent Difference|15.13|||||TWO_SIDED|95.0|-0.74|29.37|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||29.37|-0.74|
91539992|NCT04956575|182958342|OTHER||Percent Difference|19.08|||||TWO_SIDED|95.0|3.22|33.22|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against Yamagata-lineage at Day 29.||33.22|3.22|
91539993|NCT04956575|182958343|OTHER||Percent Difference|9.18|||||TWO_SIDED|95.0|-10.62|28.31|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||28.31|-10.62|
91763621|NCT01200368|183417659|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
91539994|NCT04956575|182958343|OTHER||Percent Difference|18.09|||||TWO_SIDED|95.0|-1.81|36.61|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||36.61|-1.81|
91539995|NCT04956575|182958343|OTHER||Percent Difference|23.91|||||TWO_SIDED|95.0|4.2|41.86|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||41.86|4.20|
91539996|NCT04956575|182958343|OTHER||Percent Difference|1.15|||||TWO_SIDED|95.0|-18.41|20.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||20.60|-18.41|
91539997|NCT04956575|182958343|OTHER||Percent Difference|22.21|||||TWO_SIDED|95.0|2.09|40.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.60|2.09|
91539998|NCT04956575|182958343|OTHER||Percent Difference|36.68|||||TWO_SIDED|95.0|17.38|53.36|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||53.36|17.38|
91539999|NCT04956575|182958343|OTHER||Percent Difference|-37.71|||||TWO_SIDED|95.0|-53.36|-20.45|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-20.45|-53.36|
91540000|NCT04956575|182958343|OTHER||Treatment Difference|-26.18|||||TWO_SIDED|95.0|-43.66|-6.9|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-6.90|-43.66|
91540001|NCT04956575|182958343|OTHER||Percent Difference|-19.66|||||TWO_SIDED|95.0|-37.95|0.11|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.11|-37.95|
91540002|NCT04956575|182958343|OTHER||Percent Difference|-23.43|||||TWO_SIDED|95.0|-41.09|-4.26|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||-4.26|-41.09|
91540003|NCT04956575|182958343|OTHER||Percent Difference|-4.44|||||TWO_SIDED|95.0|-24.09|15.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of against Afluria Quadrivalent Yamagata-lineage at Day 29.||15.59|-24.09|
91540004|NCT04956575|182958343|OTHER||Percent Difference|-8.79|||||TWO_SIDED|95.0|-28.13|11.27|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||11.27|-28.13|
91540005|NCT00432458|182958349|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)||||||0.02
91540006|NCT00432458|182958350|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||Chi-squared|||||||0.0048
91540007|NCT00432458|182958351|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
91540008|NCT00854906|182958356|NON_INFERIORITY_OR_EQUIVALENCE|This was a pilot study. Therefore, no formal power analyses were performed.|Mean Difference (Final Values)|0.666|STANDARD_DEVIATION|3.6||0.074|TWO_SIDED|95.0|-0.069|1.401|||t-test, 2 sided|||The paired T-test was used to compare mean KTBUT and mean FTBUT.||1.401|-0.069|0.074
91540009|NCT00854906|182958357|NON_INFERIORITY_OR_EQUIVALENCE|The analysis will evaluate the association between OSDI with KTBUT.|Pearson's Correlation, r|-0.34||||0.093|ONE_SIDED||||||Pearson's correlation|||A correlation was performed between ODSI questionnaire results and each participant's KTBUT.||||0.093
91540010|NCT00854906|182958357|SUPERIORITY_OR_OTHER||Pearson's Correlation, r|-0.26||||0.216|||||||Pearson's Correlation|||A correlation was performed between ODSI questionnaire results and each participant's FTBUT.||||0.216
91540011|NCT03482011|182958505|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|56.5|69.4|||Cochran-Mantel-Haenszel|||||69.4|56.5|<0.001
91540012|NCT03482011|182958506|SUPERIORITY||Risk Difference (RD)|57.8|||<|0.001|TWO_SIDED|95.0|51.3|64.4|||Cochran-Mantel-Haenszel|||||64.4|51.3|<0.001
91540013|NCT03482011|182958507|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|11.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|11.6|<0.001
91540014|NCT03482011|182958508|SUPERIORITY||Risk Difference (RD)|73.6|||<|0.001|TWO_SIDED|95.0|67.1|80.1|||Cochran-Mantel-Haenszel|||||80.1|67.1|<0.001
91763622|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.15||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.15|0.77|
91763623|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.23|||||TWO_SIDED|95.0|0.98|1.53||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.53|0.98|
91763624|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.67|0.98||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.67|
91540015|NCT03482011|182958509|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.001|TWO_SIDED|95.0|26.0|35.7|||Cochran-Mantel-Haenszel|||||35.7|26.0|<0.001
91763625|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.12|0.81|
91763626|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.82|||||TWO_SIDED|95.0|0.67|1.01||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.01|0.67|
91763627|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.75|||||TWO_SIDED|95.0|1.39|2.21||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||2.21|1.39|
91540016|NCT03482011|182958510|SUPERIORITY||Risk Difference (RD)|48.1|||<|0.001|TWO_SIDED|95.0|42.9|53.2|||Cochran-Mantel-Haenszel|||||53.2|42.9|<0.001
91540017|NCT03482011|182958511|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|14.5|22.1|||Cochran-Mantel-Haenszel|||||22.1|14.5|<0.001
91540018|NCT03482011|182958512|SUPERIORITY||Risk Difference (RD)|49.6|||<|0.001|TWO_SIDED|95.0|42.8|56.4|||Cochran-Mantel-Haenszel|||||56.4|42.8|<0.001
91540019|NCT03482011|182958513|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|56.0|77.5|||Cochran-Mantel-Haenszel|||||77.5|56.0|<0.001
91540020|NCT03482011|182958513|SUPERIORITY||Risk Difference (RD)|65.9|||<|0.001|TWO_SIDED|95.0|54.9|77.0|||Cochran-Mantel-Haenszel|||||77.0|54.9|<0.001
91540021|NCT03482011|182958514|SUPERIORITY||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|1.32|<|0.001|TWO_SIDED|95.0|-7.31|-2.1|||Mixed Models Analysis|||||-2.10|-7.31|<0.001
91540022|NCT03482011|182958515|SUPERIORITY||Mean Difference (Net)|-17.33|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-19.28|-15.39|||Mixed Models Analysis|||||-15.39|-19.28|<0.001
91540023|NCT03482011|182958516|SUPERIORITY||Mean Difference (Net)|-6.98|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.37|-3.58|||Mixed Models Analysis|||||-3.58|-10.37|<0.001
91540024|NCT03482011|182958517|SUPERIORITY||Mean Difference (Net)|4.86|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|3.5|6.22|||ANCOVA|||||6.22|3.50|<0.001
91540025|NCT03482011|182958518|SUPERIORITY||Mean Difference (Net)|4.78|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|3.33|6.23|||ANCOVA|||||6.23|3.33|<0.001
91540026|NCT03482011|182958519|SUPERIORITY||Risk Difference (RD)|68.1|||<|0.001|TWO_SIDED|95.0|63.2|72.9|||Cochran-Mantel-Haenszel|||||72.9|63.2|<0.001
91540027|NCT03482011|182958520|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-7.3|-0.06|||ANOVA|||Absenteeism||-0.06|-7.30|0.002
91540028|NCT03482011|182958520|SUPERIORITY||Mean Difference (Net)|-20.24|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-24.89|-15.6|||ANCOVA|||Presenteeism||-15.60|-24.89|<0.001
91540029|NCT03482011|182958520|SUPERIORITY||Mean Difference (Net)|-21.09|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-26.56|-15.62|||ANCOVA|||Overall Absenteeism and Presenteeism||-15.62|-26.56|<0.001
91540030|NCT03482011|182958520|SUPERIORITY||Mean Difference (Net)|-22.91|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-27.39|-18.43|||ANCOVA|||Impairment in Activities Performed Outside of Work||-18.43|-27.39|<0.001
91540031|NCT03482011|182958521|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.79||0.004|TWO_SIDED|95.0|-3.08|4.14|||ANCOVA|||||4.14|-3.08|0.004
91763628|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.07|0.70|
91763629|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.62|||||TWO_SIDED|95.0|1.31|1.99||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.99|1.31|
91763630|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.29|||||TWO_SIDED|95.0|0.24|0.35||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||0.35|0.24|
91763631|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.28|||||TWO_SIDED|95.0|1.07|1.54||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.54|1.07|
91540032|NCT03482011|182958522|SUPERIORITY||Risk Difference (RD)|48.8|||<|0.001|TWO_SIDED|95.0|41.6|55.9|||Cochran-Mantel-Haenszel|||||55.9|41.6|<0.001
91540033|NCT00468052|182958524|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Null hypothesis is not significantly different from group D and F.|Wilcoxon (Mann-Whitney)|||Sixty subjects were required per group to determine that with Dex would decrease the incidence of severe EA after surgery by 50% with 80% power (0.05)in comparison with the control group.60 subjects were required by group to show the that intraoperative rescue fentanyl and rescue morphine in the PACU would be 50% lower in subjects receiving dex.||||.001
91540034|NCT00468052|182958524|NON_INFERIORITY_OR_EQUIVALENCE|Treatment with Dex would reduce the incidence of severe agitation be 50% with an 80% power (alpha 0.05)||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis dexmedetomidine would be a safe and effective substitute to opiates in reducing pain and the incidence of severe EA||||.001
91540035|NCT00468052|182958525|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
91540036|NCT00468052|182958527|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
91540037|NCT00468052|182958528|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
91540038|NCT04707313|182958537|SUPERIORITY||Difference to placebo|-5.6|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-7.41|-3.74|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.74|-7.41|<.0001
91540039|NCT04707313|182958537|SUPERIORITY||Difference to placebo|-5.0|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-6.8|-3.16|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.16|-6.80|<.0001
91540040|NCT04707313|182958537|SUPERIORITY||Difference to Placebo|-9.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-10.89|-7.28|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.28|-10.89|<.0001
91540041|NCT04707313|182958537|SUPERIORITY||Difference to Placebo|-6.6|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-8.75|-4.39|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.39|-8.75|<.0001
91540042|NCT04707313|182958537|SUPERIORITY||Difference to Placebo|-9.52|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.43|-7.56|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.56|-11.43|<.0001
91540043|NCT04707313|182958537|SUPERIORITY||Difference to Placebo|-7.12|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|90.0|-9.41|-4.78|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.78|-9.41|<.0001
91540044|NCT04707313|182958537|SUPERIORITY||Difference to Placebo|-9.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.11|-7.08|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.08|-11.11|<.0001
91540045|NCT04707313|182958537|SUPERIORITY||Difference to Placebo|-7.18|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-9.32|-4.99|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.99|-9.32|<.0001
91540046|NCT04707313|182958538|SUPERIORITY||Difference to Placebo|-8.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.66|-4.63|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.63|-11.66|<.0001
91540047|NCT04707313|182958538|SUPERIORITY||Difference to placebo|-8.44|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.83|-4.92|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.92|-11.83|<.0001
91540048|NCT04707313|182958538|SUPERIORITY||Difference to Placebo|-12.87|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-16.15|-9.47|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-9.47|-16.15|<.0001
91540049|NCT04707313|182958551|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|7.37|||||TWO_SIDED|90.0|2.81|19.3||||||||19.30|2.81|
91540050|NCT04707313|182958551|SUPERIORITY||Odds Ratio (OR)|6.58|||||TWO_SIDED|90.0|2.62|16.53||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||16.53|2.62|
91540051|NCT04707313|182958551|SUPERIORITY||Odds Ratio (OR)|16.33|||||TWO_SIDED|90.0|6.47|41.24||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||41.24|6.47|
91540052|NCT04707313|182958551|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|14.24|||||TWO_SIDED|90.0|5.39|37.66||||||||37.66|5.39|
91763632|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.76|||||TWO_SIDED|95.0|1.46|2.12||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.12|1.46|
91763633|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.26|||||TWO_SIDED|95.0|1.04|1.52||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.52|1.04|
91540053|NCT04707313|182958551|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|30.17|||||TWO_SIDED|90.0|11.35|80.2||||||||80.20|11.35|
91540054|NCT04707313|182958551|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|9.88|||||TWO_SIDED|90.0|2.91|33.53||||||||33.53|2.91|
91540055|NCT04707313|182958551|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|24.41|||||TWO_SIDED|90.0|8.28|71.95||||||||71.95|8.28|
91540056|NCT04707313|182958551|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|12.65|||||TWO_SIDED|90.0|4.56|35.08||||||||35.08|4.56|
91763634|NCT01200368|183417660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.85|||||TWO_SIDED|95.0|1.54|2.24||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.24|1.54|
91763635|NCT01200368|183417661|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
91763636|NCT01200368|183417661|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
91763637|NCT01200368|183417661|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
91763638|NCT01200368|183417661|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
91763639|NCT01200368|183417662|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.97|1.24||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.24|0.97|
91540057|NCT04707313|182958552|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|33.43|||||TWO_SIDED|90.0|3.05|366.64||||||||366.64|3.05|
91540058|NCT04707313|182958552|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|34.04|||||TWO_SIDED|90.0|3.1|373.85||||||||373.85|3.10|
91540059|NCT04707313|182958552|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|127.21|||||TWO_SIDED|90.0|10.55|1533.46||||||||1533.46|10.55|
91540060|NCT02459899|182958563|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.139||0.07|TWO_SIDED|95.0|-0.53|0.02||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||0.02|-0.53|0.07
91763640|NCT01200368|183417662|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.06|0.77|
91540061|NCT02459899|182958563|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-0.75|-0.22||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.22|-0.75|<0.001
91540062|NCT02459899|182958563|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.136||0.006|TWO_SIDED|95.0|-0.65|-0.11||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.11|-0.65|0.006
91540063|NCT02739035|182958569|SUPERIORITY|A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.||||||0.23||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.23
91763641|NCT01200368|183417663|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.10|0.87|
91763642|NCT01200368|183417663|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.05|0.81|
91763643|NCT01200368|183417664|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.15|0.88|
91763644|NCT01200368|183417664|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.85|1.19||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.19|0.85|
91763645|NCT01200368|183417665|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.11|0.84|
91763646|NCT01200368|183417665|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||0.91|0.70|
91763647|NCT01290757|183417674|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.082|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
91763648|NCT01290757|183417674|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.33||||||90.0|119.45|133.6|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.60|119.45|
91763649|NCT01290757|183417675|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.085|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
91540064|NCT02739035|182958570|SUPERIORITY|A difference of 10 degrees in total mean range of motion (ROM) between the control and the treatment group was considered a clinically significant improvement. To detect this difference, a previous study's mean and standard deviation were referenced in order to predict the variation of results. 54 patients per arm were required to have 90% power with a two-sided t-test and a type I error rate of 5%. 130 patients were targeted for recruitment to account for up to a 20% dropout rate.||||||0.81||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.81
91540065|NCT04446117|182958592|SUPERIORITY||Cox Proportional Hazard|0.65||||0.0007|TWO_SIDED|95.0|0.5|0.84||Stratification factors used: Liver metastasis, prior docetaxel use for locally advanced or metastatic castration-sensitive prostate cancer (mCSPC) and disease state at first NHT.|Log Rank||Stratification factors used: Liver metastasis, prior docetaxel use for locally advanced or mCSPC and disease state at first NHT.|||0.84|0.50|0.0007
91540066|NCT04446117|182958593|SUPERIORITY||Cox Proportional Hazard|0.89||||0.2956|TWO_SIDED|95.0|0.72|1.1||Stratification factors used: Liver metastasis, prior docetaxel use for locally advanced or mCSPC and disease state at first NHT.|Log Rank|||||1.10|0.72|0.2956
91540067|NCT03165175|182958594|SUPERIORITY|||||||0.72||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.72
91540068|NCT03165175|182958595|SUPERIORITY|||||||0.598||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.598
91540069|NCT03165175|182958596|SUPERIORITY|||||||0.954||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.954
91540070|NCT03165175|182958597|SUPERIORITY|||||||0.167||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.167
91763650|NCT01290757|183417675|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.49||||||90.0|118.69|132.67|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.67|118.69|
91540071|NCT03165175|182958598|SUPERIORITY|||||||0.022||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.022
91763651|NCT01290757|183417676|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.74||||||90.0|118.32|131.51|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.51|118.32|
91763652|NCT01290757|183417677|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.22||||||90.0|119.36|133.47|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.47|119.36|
91763653|NCT01290757|183417678|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.3||||||90.0|118.42|132.59|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.59|118.42|
91540072|NCT01579916|182958619|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference greater than or equal to 5 percentage points. This corresponds to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|Rate difference|-1.7|||||TWO_SIDED|95.0|-8.9|0.6|||Score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points||0.6|-8.9|
91540073|NCT00114101|182958651|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.|Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.53||Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.|Log Rank|||||0.53|0.26|<0.001
91540074|NCT00114101|182958653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.7|TWO_SIDED|95.0|0.26|1.02|||Log Rank|||||1.02|0.26|0.70
91540075|NCT00114101|182958654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.41|0.69|||Fisher Exact|||||0.69|0.41|<0.001
91540076|NCT01786564|182958667|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.075||||0.13|TWO_SIDED|95.0|-0.173|0.023||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|||The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.||.023|-.173|.13
91540077|NCT01786564|182958667|OTHER|This is cross-sectional analysis|Regression Coefficient|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted.||The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.||1.19|-0.95|.83
91540078|NCT01786564|182958667|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.05||||0.39|TWO_SIDED|95.0|-0.166|0.66||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|Unadjusted||The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.||0.66|-.166|.39
91540079|NCT01786564|182958667|OTHER|Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression Coefficient|-0.058||||0.11|TWO_SIDED|95.0|-0.129|0.014||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted association.||The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.||.014|-.129|.11
91540080|NCT02138006|182958668|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Log Rank|||||||0.30
91540081|NCT00424762|182958670|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||powered to detect at least 33% difference between groups||||>0.05
91540082|NCT00424762|182958671|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||powered to detect difference of at least 10% between groups||||0.26
91540083|NCT00424762|182958672|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||comparative incidence||||0.03
91540084|NCT00723450|182958728|SUPERIORITY_OR_OTHER|||||||0.0717||95.0|||||Log Rank|A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.||||||0.0717
91540085|NCT02326649|182958750|OTHER|||||||0.47|||||||paired t-test|||||||0.47
91540086|NCT02326649|182958750|OTHER||Mean Difference (Final Values)|6.561|STANDARD_ERROR_OF_MEAN|5.528||0.255|TWO_SIDED|95.0|-5.295|18.417|||Regression, Linear|||Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||18.417|-5.295|0.255
91540087|NCT02326649|182958750|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.417||0.25|TWO_SIDED|95.0|-0.395|1.395|||Regression, Linear|||Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.395|-0.395|0.250
91763654|NCT01290757|183417679|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.49||||||90.0|118.11|131.21|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.21|118.11|
91763655|NCT00570310|183417680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.003||90.0|-2.25|-0.6||1-sided, alpha = 0.05|ANOVA||Primary Hypothesis: In 'primary responder population', pregabalin is superior to placebo in maintaining pain control measured by change (3-day average: end of the randomization period versus end of maintenance period) in evening pain intensity.|||-0.60|-2.25|0.003
91763656|NCT00570310|183417681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.67|||<|0.001||95.0|5.26|10.08||1-sided, alpha = 0.05|ANOVA|||||10.08|5.26|<0.001
91763657|NCT00759161|183417690|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||< 0.001
91763658|NCT01337336|183417702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.002||95.0|1.08|1.56|||Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.56|1.08|0.002
91763659|NCT01337336|183417703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002||95.0|1.02|2.38||COPD-related hospitalization|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.38|1.02|0.002
91540088|NCT02326649|182958750|OTHER||Mean Difference (Final Values)|-0.427|STANDARD_ERROR_OF_MEAN|0.305||0.183|TWO_SIDED|95.0|-1.081|0.227|||Regression, Linear|||Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||0.227|-1.081|0.183
91540089|NCT02326649|182958750|OTHER||Mean Difference (Final Values)|0.557|STANDARD_ERROR_OF_MEAN|0.452||0.238|TWO_SIDED|95.0|-0.411|1.526|||Regression, Linear|||Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.526|-0.411|0.238
91540090|NCT02311907|182958751|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Generalized linear models (repeated measures analysis of variance \[ANOVA\]) will be used to compare the CIPN between GSH and placebo arms.||||0.21
91540091|NCT02311907|182958752|SUPERIORITY_OR_OTHER|||||||0.63|||||||Log Rank|||||||0.63
91540092|NCT02950558|182958760|OTHER|||||||0.1269|||||||Wilcoxon (Mann-Whitney)|||||||0.1269
91540093|NCT02950558|182958761|OTHER|||||||0.8808|||||||Wilcoxon (Mann-Whitney)|||||||0.8808
91540094|NCT02950558|182958762|OTHER|||||||0.0382|||||||Wilcoxon (Mann-Whitney)|||||||0.0382
91540095|NCT02950558|182958763|OTHER|||||||0.4696|||||||Wilcoxon (Mann-Whitney)|||||||0.4696
91540096|NCT02950558|182958764|OTHER|||||||0.1818|||||||Fisher Exact|||||||0.1818
91540097|NCT04001517|182958772|SUPERIORITY||Mean Difference (Net)|0.175||||0.049|TWO_SIDED|95.0|0.001|0.345||The comparison is of neflamapimod 40mg TID to placebo. The p-value was not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. The positive value represents a better outcome with neflamapimod 40mg treatment vs. placebo.|This was an exploratory trial and no explicit a priori hypothesis was established and contained in the protocol. As such, no formal power calculations were conducted. The primary objective of the study was to evaluate the effects of neflamapimod on cognition, and accordingly the primary endpoint was change in combined z-score of the six tests in the NTB, analyzed by Linear Mixed Effects (LME) model for repeated measures.||0.345|0.001|0.049
91540098|NCT04001517|182958772|SUPERIORITY|Comparison of combined neflamapimod groups vs. placebo.|||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
91540099|NCT04001517|182958773|SUPERIORITY|Comparison of combined neflamapimod 40mg TID vs. placebo. The p-value is not adjusted for multiple comparisons.|Mean Difference (Net)|-0.56||||0.007|TWO_SIDED|95.0|-0.96|-0.16||Comparison of combined neflamapimod dose groups vs. placebo utilizing mixed model for repeated measures with baseline as a covariate. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. A negative value indicates improvement compared to placebo.|||-0.16|-0.96|0.007
91540100|NCT04001517|182958773|SUPERIORITY||Mean Difference (Net)|-0.45||||0.023|TWO_SIDED|95.0|-0.83|-0.06||Mixed model for repeated measures with baseline as a covariate. The p-value was not adjusted for multiple comparisons|Mixed Models Analysis||Comparison of combined neflamapimod dose groups vs. placebo. Negative values represents a better outcome with neflamapimod relative to placebo.|A secondary analysis was conducted comparing the combined neflamapimod dose groups vs. placebo.||-0.06|-0.83|0.023
91540101|NCT04001517|182958774|SUPERIORITY||||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
91540102|NCT04001517|182958775|OTHER||Mean Difference (Net)|-1.53||||0.15|TWO_SIDED|95.0|-3.61|0.55|||Mixed Models Analysis|||||.55|-3.61|0.15
91763660|NCT01337336|183417703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002||95.0|1.14|2.39||COPD-related ER visit|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.39|1.14|0.002
91540103|NCT04001517|182958775|SUPERIORITY||Mean Difference (Net)|-1.31||||0.077|TWO_SIDED|95.0|-5.03|2.34|||Mixed Models Analysis|||Comparison of combined neflamapimod groups (i.e., all neflamapimod) vs. placebo||2.34|-5.03|0.077
91540104|NCT04001517|182958776|SUPERIORITY||Mean Difference (Net)|0.32|||>|0.2|TWO_SIDED|95.0|-1.27|1.91|||Mixed Models Analysis||Comparison of change from baseline over course of study for NFMD 40mg TID vs. placebo.|||1.91|-1.27|>0.2
91540105|NCT04001517|182958777|OTHER||Mean Difference (Net)|-1.4||||0.024|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis||Mean difference for the comparison of 40 mg TID vs. placebo is reported.|||-0.2|-2.6|0.024
91540106|NCT04001517|182958777|SUPERIORITY|Comparison of combined neflamapimod dose groups vs. placebo.|Mean Difference (Net)|-1.36||||0.044|TWO_SIDED|95.0|-2.69|-0.04|||Mixed Models Analysis|||||-0.04|-2.69|0.044
91540107|NCT02547922|182958789|SUPERIORITY||Geometric Mean Ratio|1.031||||0.9052|TWO_SIDED|95.0|0.621|1.713||The p-values presented are unadjusted and was compared with the respective adjusted significance level (α). If α is not displayed, no formal testing can be performed and the corresponding p-value was nominal.|Mixed Models Analysis||Geometric mean ratio \>1 favours placebo.|The model includes fixed effects for treatment group, visit, stratification factors, log-transformed 24-hour UPCR at baseline, and treatment-by-visit interaction. All data up to and including the date of discontinuation of study treatment were included in the analysis.||1.713|0.621|0.9052
91540108|NCT02547922|182958790|SUPERIORITY||Difference in estimates|-0.08||||0.9929|TWO_SIDED|95.0|-16.92|16.76||At Week 52, the p-values presented are unadjusted and will be compared to the respective adjusted significance level (α). If α is not displayed no formal testing can be performed and the corresponding p-value is nominal.|Cochran-Mantel-Haenszel|||The statistical analysis represents the estimated percentage of responders. The responder/non-responder rates (percentages), the difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach.||16.76|-16.92|0.9929
91540109|NCT02709655|182958795|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|1.24||0.0937|TWO_SIDED|95.0|-4.54|0.36|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.36|-4.54|0.0937
91540110|NCT02709655|182958795|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.44||0.2336|TWO_SIDED|95.0|-4.56|1.11|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||1.11|-4.56|0.2336
91540111|NCT02709655|182958795|OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|1.44||0.0879|TWO_SIDED|95.0|-5.29|0.37|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.37|-5.29|0.0879
91540112|NCT02709655|182958795|OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.7||0.0531|TWO_SIDED|95.0|-6.65|0.04|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.04|-6.65|0.0531
91540113|NCT00102063|182958816|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
91540114|NCT00102063|182958816|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
91763661|NCT01337336|183417703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.503||95.0|0.93|1.4|||Chi-squared|COPD-related physician + Rx visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.40|0.93|0.503
91540115|NCT00857649|182958824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.52||0.418|TWO_SIDED|95.0|-1.75|4.21|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||4.21|-1.75|0.418
91540116|NCT00857649|182958825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.92||0.603|TWO_SIDED|95.0|-2.3|1.34|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||1.34|-2.30|0.603
91540117|NCT00857649|182958826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.734|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||0.31|-0.22|0.734
91540118|NCT00857649|182958827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.017|TWO_SIDED|95.0|-3.29|-0.32|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||-0.32|-3.29|0.017
91540119|NCT00857649|182958828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.98||0.36|TWO_SIDED|95.0|-1.03|2.83|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||2.83|-1.03|0.360
91763662|NCT01337336|183417703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71|||<|0.001||95.0|1.26|2.31|||Chi-squared|COPD-related hospitalization/ER visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.31|1.26|<0.001
91763663|NCT01337336|183417705|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.46||||0.0004||95.0|1.01|2.09||COPD-related hospitalization|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.09|1.01|0.0004
91540120|NCT04470193|182958844|SUPERIORITY|We approached 62 subjects to get a sample size of 50 participants, allowing up to 16% attrition, to estimate the proportions of patients satisfying dropout of 0.13 to within margins of error (half-widths of 90% Cis). The 50 evaluable subjects were used to estimate the SD of QoL, with a margin of error of ∼20%. The sample size also allowed us to provide provisional estimates of the effect size for the QoL outcome to within a margin of error of ±7.1 points, assuming a true SD of 15 points.|||||>|0.05|||||||generalized estimating equation model|||We used a generalized estimating equation model for repeated assessments, with a common unstructured residual covariance matrix to account for correlation in repeated measurements in the same patient, to compare QoL total score at baseline, 1 month, and 3 months between the groups. We hypothesized that MyChildCMC users would have better outcomes for the child (higher QoL, fewer ED and/or hospital use and hospital days) and parent (higher satisfaction with child's care).||||>0.05
91540121|NCT04470193|182958845|SUPERIORITY||Risk Ratio (RR)|1.05||||0.882|TWO_SIDED|95.0|0.58|1.88|||Mixed Models Analysis|||||1.88|0.58|0.882
91540122|NCT04470193|182958846|SUPERIORITY||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.62|||Mixed Models Analysis|||||0.62|0.39|<0.001
91540123|NCT04470193|182958847|SUPERIORITY||Risk Ratio (RR)|1.11||||0.035|TWO_SIDED|95.0|1.01|1.22|||Mixed Models Analysis|||||1.22|1.01|0.035
91540124|NCT02517307|182958848|OTHER|||||||0.136|||||||Mixed Models Analysis|||We compared the effects of intralipid on Rd in controls subjects versus subjects with a FAOD by mixed-effect models. Factors were group (control or FAOD) treatment (glycerol or intralipid) and the interaction of those factors. The hypothesis was intralipid would decrease Rd in controls but not in subjects with an FAOD.||||0.136
91540125|NCT02517307|182958849|OTHER|We analyzed the data with a mixed model looking at the effect of group (control vs FAOD) and treatment (glycerol vs intralipid) and their interaction.||||||0.011|||||||Mixed Models Analysis|||We tested if intralipid did not suppress endogenous glucose production or Ra as much as glycerol in controls compared to subjects with an FAOD.||||0.011
91540126|NCT00843882|182958850|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
91540127|NCT00843882|182958859|SUPERIORITY|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
91540128|NCT02248480|182958863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91763664|NCT01337336|183417705|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.27||||0.208||95.0|0.89|1.82||COPD-related ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.82|0.89|0.208
91763665|NCT01337336|183417705|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.09||||0.671||95.0|0.9|1.32||COPD-related physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.32|0.90|0.671
91540129|NCT01582269|182958890|SUPERIORITY||Hazard Ratio (HR)|0.9336|||||TWO_SIDED|95.0|0.58|1.49|||Bayesian exponential-likelihood model|||The Bayesian analyses below include credible intervals rather than confidence intervals for the hazard ratios.|The posterior probability treatment difference is 0.6158|1.49|0.58|
91540130|NCT01582269|182958890|SUPERIORITY||Hazard Ratio (HR)|1.129|||||TWO_SIDED|95.0|0.78|1.65|||Bayesian exponential-likelihood model|||The Bayesian analyses below include credible intervals rather than confidence intervals for the hazard ratios.|The posterior probability treatment difference is 0.2628|1.65|0.78|
91540131|NCT03360396|182958902|OTHER|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||||||||||||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||Study was closed early in all regions except for France. SAP was updated to include descriptive statistics only. French sites remain open.||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|||
91540132|NCT03360396|182958903|OTHER|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||||||||||||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|||
91763666|NCT01337336|183417705|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.31||||0.009||95.0|1.05|1.72||COPD-related hospitalization/ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.72|1.05|0.009
91540133|NCT00546871|182958936|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.067|||||ONE_SIDED|99.0||0.134||||||||0.134||
91540134|NCT04036058|182958957|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
91540135|NCT04036058|182958958|SUPERIORITY|||||||0.0435|||||||t-test, 2 sided|||||||0.0435
91540136|NCT04036058|182958959|SUPERIORITY|||||||0.1158|||||||t-test, 2 sided|||||||0.1158
91540137|NCT04036058|182958960|SUPERIORITY|||||||0.0898|||||||t-test, 2 sided|||||||0.0898
91540138|NCT04036058|182958961|SUPERIORITY|||||||0.114|||||||t-test, 2 sided|||||||0.114
91540139|NCT06001177|182958968|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.185||0.1668|TWO_SIDED|95.0|-0.63|0.11||P-value was based on an ANCOVA model with treatment as a factor and baseline as a covariate.|ANCOVA|||||0.11|-0.63|0.1668
91540140|NCT03593876|182958978|OTHER||||||||||||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess mean participant-therapist communication scores across intervention sessions. The mean and standard deviation of these scores was 3.00 (1.00). The a priori criterion for feasibility was a mean score of 2.0 or greater.|||
91763667|NCT01337336|183417705|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.16||||0.052||95.0|0.98|1.37||COPD-related hospitalization/ER visit/physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.37|0.98|0.052
91540141|NCT03593876|182958979|OTHER||Mean Difference (Net)|51.71|STANDARD_DEVIATION|21.04|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change was Cohen's d(rm)=3.08.|||
91540142|NCT03593876|182958980|OTHER||Mean Difference (Net)|11.02|STANDARD_DEVIATION|7.24|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change, Cohen's d(rm)=1.70|||
91540143|NCT02696707|182959009|NON_INFERIORITY|The non-inferiority margin between groups was set as 4%|Difference|-0.6|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
91540144|NCT00071799|182959013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|95.0|||||Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||"A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 9.8 and high range of 17.0 months."||||0.0001
91540145|NCT00071799|182959013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.0002|TWO_SIDED|95.0|0.43|0.77|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.77|0.43|0.0002
91540146|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 7.1 months and high range of 15.6 months.~Conventional Care: low range of 4.4 and high range of 12.4 months."||||0.3973
91540147|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 65 years~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 34.7 months.~Conventional Care: low range of 8.8 and high range of 16.4 months."||||<0.0001
91540148|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0707||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 1.7 months and high range of 15.0 months.~Conventional Care: low range of 4.1 and high range of 7.6 months."||||0.0707
91540149|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0042||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Male~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 10.8 and high range of 17.2 months."||||0.0042
91540150|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0469||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Female~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 13.0 months and high range of 'does not exist'.~Conventional Care: low range of 8.2 and high range of 17.6 months."||||0.0469
91540151|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 21.1 months and high range of 'does not exist'.~Conventional Care: low range of 9.3 and high range of 21.9 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0056
91763668|NCT00757237|183417709|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-7.8||||0.0001|TWO_SIDED|95.0|-11.73|-3.86||Based on the Benjamini \& Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means \[TIS-AZLI\] of -3.2%.||-3.86|-11.73|0.0001
91540152|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"FAB: RAEB in transformation~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 11.7 months and high range of 'does not exist'.~Conventional Care: low range of 9.4 and high range of 17.0 months."||||0.0322
91540153|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 6.6 months and high range of 'does not exist'.~Conventional Care: low range of 1.8 and high range of 9.8 months."||||0.1679
91540154|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB-2~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.9 months and high range of 'does not exist'.~Conventional Care: low range of 8.8 and high range of 19.4 months."||||0.0692
91540155|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: Other~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.6 months and high range of 'does not exist'.~Conventional Care: low range of 11.1 and high range of 17.5 months."||||0.0017
91540156|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 'does not exist'.~Conventional Care: low range of 8.7 and high range of 24.1 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.1030
91540157|NCT00071799|182959014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 15.0 months and high range of 'does not exist'.~Conventional Care: low range of 9.0 and high range of 17.0 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification||IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0020
91540158|NCT00071799|182959015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.|Log Rank|||||||0.0025
91540159|NCT00071799|182959015|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.0027|TWO_SIDED|95.0|0.53|0.87|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.87|0.53|0.0027
91540160|NCT00071799|182959016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2555||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||0.2555
91540161|NCT00071799|182959016|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.2562|TWO_SIDED|95.0|0.6|1.15|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||1.15|0.60|0.2562
91540162|NCT00071799|182959017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.||||<0.0001
91540163|NCT00071799|182959018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||0.0005
91540164|NCT00071799|182959019|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period||||1.000
91540165|NCT00071799|182959020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||<0.0001
91540166|NCT00071799|182959021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Fisher Exact|||Overall (Complete + Partial Remission)||||0.0001
91540167|NCT00071799|182959021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0|||||Fisher Exact|||Complete remission||||0.0150
91540168|NCT00071799|182959021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094||95.0|||||Fisher Exact|||Partial Remission||||0.0094
91540169|NCT00071799|182959021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3297||95.0|||||Fisher Exact|||Stable Disease||||0.3297
91540170|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Any Improvement||||<0.0001
91540171|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Erythroid Response - Major||||<0.0001
91540172|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6203||95.0|||||Fisher Exact|||Erythroid Response - Minor||||0.6203
91540173|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Fisher Exact|||Platelet Response - Major||||0.0003
91540174|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7514||95.0|||||Fisher Exact|||Platelet Response - Minor||||0.7514
91763669|NCT00757237|183417710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0023||||||Based on the Benjamini \& Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|MMRM analysis|MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.|Treatment difference refers to TIS-AZLI.|"Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants.~With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%."||||0.0023
91540175|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8695||95.0|||||Fisher Exact|||Neutrophil Response - Major||||0.8695
91540176|NCT00071799|182959022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Fisher Exact|||Neutrophil Response - Minor||||0.1760
91540177|NCT00071799|182959023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0466
91540178|NCT00071799|182959023|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0474|TWO_SIDED|95.0|0.53|1.0|||Regression, Cox|||||1.00|0.53|0.0474
91540179|NCT00071799|182959024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0002
91540180|NCT00071799|182959025|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67||||0.1327|TWO_SIDED|95.0|0.35|1.2|||exact binomial|||||1.20|0.35|0.1327
91540181|NCT00071799|182959027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||<0.0001
91540182|NCT00071799|182959027|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.35|0.7|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.70|0.35|<0.0001
91540183|NCT03034915|182959065|OTHER||Mean Difference (Net)|0.066|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.043|0.089|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.089|0.043|<0.001
91540184|NCT03034915|182959065|OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.0117|<|0.001|TWO_SIDED|95.0|0.118|0.164|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.164|0.118|<0.001
91540185|NCT03034915|182959065|OTHER||Mean Difference (Net)|0.075|STANDARD_ERROR_OF_MEAN|0.0119|<|0.001|TWO_SIDED|95.0|0.051|0.098|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.098|0.051|<0.001
91540186|NCT03034915|182959066|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.157||0.018|TWO_SIDED|95.0|0.06|0.68|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.68|0.06|0.018
91540187|NCT03034915|182959066|OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.155||0.004|TWO_SIDED|95.0|0.15|0.76|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.76|0.15|0.004
91540188|NCT03034915|182959066|OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.159||0.61|TWO_SIDED|95.0|-0.23|0.39|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24|||0.39|-0.23|0.610
91540189|NCT03034915|182959067|OTHER||Odds Ratio (OR)|1.43|||<|0.001|TWO_SIDED|95.0|1.17|1.75|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 24|||1.75|1.17|<0.001
91540190|NCT03034915|182959067|OTHER||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.21|1.81|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24|||1.81|1.21|<0.001
91540191|NCT03034915|182959067|OTHER||Odds Ratio (OR)|1.03||||0.755|TWO_SIDED|95.0|0.84|1.27|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.27|0.84|0.755
91540192|NCT03034915|182959068|OTHER||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.213||0.013|TWO_SIDED|95.0|-0.95|-0.11|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.11|-0.95|0.013
91540193|NCT03034915|182959068|OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.211|<|0.001|TWO_SIDED|95.0|-1.25|-0.42|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24..|||-0.42|-1.25|<0.001
91540194|NCT03034915|182959068|OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.214||0.159|TWO_SIDED|95.0|-0.72|0.12|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24|||0.12|-0.72|0.159
91540195|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.114||0.016|TWO_SIDED|95.0|-0.5|-0.05||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||-0.05|-0.50|0.016
91540196|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-0.68|-0.23||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.23|-0.68|<0.001
91540197|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.115||0.115|TWO_SIDED|95.0|-0.41|0.04||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.04|-0.41|0.115
91540198|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.063||0.247|TWO_SIDED|95.0|-0.2|0.05||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||0.05|-0.20|0.247
91540199|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.063||0.042|TWO_SIDED|95.0|-0.25|0.0||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||0.00|-0.25|0.042
91540200|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.063||0.391|TWO_SIDED|95.0|-0.18|0.07||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.18|0.391
91540201|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.31|-0.04||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.04|-0.31|0.014
91540202|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.37|-0.1||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comapring UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.10|-0.37|<0.001
91540203|NCT03034915|182959069|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.34|TWO_SIDED|95.0|-0.2|0.07||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.20|0.340
91540204|NCT03034915|182959070|OTHER||Odds Ratio (OR)|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 21 to Week 24|||1.89|1.22|<0.001
91540205|NCT03034915|182959070|OTHER||Odds Ratio (OR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.9|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||1.90|1.23|<0.001
91540206|NCT03034915|182959070|OTHER||Odds Ratio (OR)|1.0||||0.969|TWO_SIDED|95.0|0.8|1.26|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 21 to Week 24.|||1.26|0.80|0.969
91540207|NCT03034915|182959071|OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.672||0.709|TWO_SIDED|95.0|-1.07|1.57|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||1.57|-1.07|0.709
91540208|NCT03034915|182959071|OTHER||Mean Difference (Net)|-1.69|STANDARD_ERROR_OF_MEAN|0.665||0.011|TWO_SIDED|95.0|-2.99|-0.39|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||-0.39|-2.99|0.011
91540209|NCT03034915|182959071|OTHER||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|0.678||0.004|TWO_SIDED|95.0|-3.27|-0.61|||mixed model repeated measure||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||-0.61|-3.27|0.004
91540210|NCT03034915|182959072|OTHER||Odds Ratio (OR)|1.21||||0.063|TWO_SIDED|95.0|0.99|1.48|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.48|0.99|0.063
91540211|NCT03034915|182959072|OTHER||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.83|1.22|<0.001
91540212|NCT03034915|182959072|OTHER||Odds Ratio (OR)|1.23||||0.045|TWO_SIDED|95.0|1.0|1.51|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.51|1.00|0.045
91540213|NCT03034915|182959073|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.891|TWO_SIDED|95.0|-0.6|0.6|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.6|-0.6|0.891
91540214|NCT03034915|182959073|OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.074|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.1|-1.1|0.074
91540215|NCT03034915|182959073|OTHER||Odds Ratio (OR)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.107|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.1|-1.1|0.107
91540216|NCT03034915|182959074|OTHER||Odds Ratio (OR)|1.35||||0.003|TWO_SIDED|95.0|1.11|1.65|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.65|1.11|0.003
91540217|NCT03034915|182959074|OTHER||Odds Ratio (OR)|1.23||||0.037|TWO_SIDED|95.0|1.01|1.5|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.50|1.01|0.037
91540218|NCT03034915|182959074|OTHER||Odds Ratio (OR)|0.91||||0.363|TWO_SIDED|95.0|0.75|1.11|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.11|0.75|0.363
91540219|NCT03861767|182959076|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.67|1.97||||||Low dose groups collapsed and compared to placebo||1.97|0.67|
91540220|NCT03861767|182959076|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.42|1.25||||||Intermediate dose groups were collapsed and compared to placebo||1.25|0.42|
91540221|NCT03861767|182959076|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.61|1.84||||||High dose groups were collapsed and compared to placebo||1.84|0.61|
91540222|NCT03861767|182959077|SUPERIORITY||Odds Ratio (OR)|1.03||||0.92|TWO_SIDED|95.0|0.52|2.03|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.03|0.52|0.92
91540223|NCT03861767|182959078|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8|TWO_SIDED|95.0|0.52|2.0|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.00|0.52|0.80
91540224|NCT03861767|182959079|SUPERIORITY||Odds Ratio (OR)|1.23||||0.65|TWO_SIDED|95.0|0.49|3.11|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.11|0.49|0.65
91540225|NCT03861767|182959080|SUPERIORITY||Odds Ratio (OR)|1.62||||0.23|TWO_SIDED|95.0|0.73|3.62|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.62|0.73|0.23
91540226|NCT03861767|182959081|SUPERIORITY||Odds Ratio (OR)|1.42||||0.31|TWO_SIDED|95.0|0.71|2.86|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.86|0.71|0.31
91540227|NCT03861767|182959082|SUPERIORITY||Beta-coefficient|0.0011|STANDARD_ERROR_OF_MEAN|0.042||0.97|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.97
91540228|NCT03861767|182959083|SUPERIORITY||Beta-coefficient|-0.76|STANDARD_ERROR_OF_MEAN|0.74||0.3|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.30
91540229|NCT03861767|182959084|SUPERIORITY||Beta-coefficient|0.27|STANDARD_ERROR_OF_MEAN|0.59||0.65|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.65
91540230|NCT03861767|182959086|SUPERIORITY||Odds Ratio (OR)|1.45||||0.27|TWO_SIDED|95.0|0.74|2.86|||Regression, Logistic|||||2.86|0.74|0.27
91540231|NCT03861767|182959087|SUPERIORITY||Odds Ratio (OR)|2.98||||0.01|TWO_SIDED|95.0|1.19|7.44|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||7.44|1.19|0.01
91763670|NCT00757237|183417711|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-13.86|-5.14||Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.|ANCOVA|ANCOVA model included treatment and Day 0 FEV1 percent predicted.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having \>= 84 days of inhaled tobramycin use in the previous 12 months.||-5.14|-13.86|<0.0001
91763671|NCT00757237|183417712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.0002||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|MMRM analysis|MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.|Treatment difference refers to TIS-AZLI|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having \>=84 days of inhaled tobramycin use in the previous 12 months.||||0.0002
91540232|NCT03861767|182959088|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.01|TWO_SIDED|95.0|1.34|5.3|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||5.30|1.34|<0.01
91540233|NCT03861767|182959089|SUPERIORITY||Odds Ratio (OR)|0.9||||0.72|TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.||1.56|0.52|0.72
91540234|NCT00346333|182959091|SUPERIORITY_OR_OTHER|||||||0.66||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||"Primary Analysis:Proc mixed of the Statistical Analysis System (SAS) was used to compare annual rates of change by treatment group over 4 years.~Power Calculation:240 patients were estimated to be needed to provide sufficient power (i.e. alpha=0.05;beta=0.10)to observe a statistically significant difference between mean change in the 2 groups on the HFA 30-2 total point score over a 4-year interval."||||0.66
91540235|NCT00346333|182959091|SUPERIORITY_OR_OTHER|||||||0.52||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.52
91540236|NCT00346333|182959092|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary Analysis: Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye. Each patient contributed 2, 1, or 0 eyes with non-missing data.||||0.05
91763672|NCT00757237|183417713|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.||||0.0025
91540237|NCT00346333|182959092|SUPERIORITY_OR_OTHER|||||||0.03||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.03
91540238|NCT00346333|182959093|SUPERIORITY_OR_OTHER|||||||0.24||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary analysis:Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||||0.24
91763673|NCT00757237|183417714|SUPERIORITY_OR_OTHER|||||||0.1114||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.||||0.1114
91540239|NCT00346333|182959093|SUPERIORITY_OR_OTHER|||||||0.2||||||Apriori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.20
91540240|NCT00346333|182959094|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over four years between the treatment groups.||||0.59
91540241|NCT00346333|182959095|SUPERIORITY_OR_OTHER|||||||0.8||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over 4 years between the 2 groups.||||0.80
91540242|NCT01188499|182959096|SUPERIORITY_OR_OTHER||Percent|100.0|||||TWO_SIDED||||||||Primary objective of safety and tolerability measured by percent participants experiencing at least one adverse event. No formal statistics performed.|||||
91540243|NCT01188499|182959097|SUPERIORITY_OR_OTHER||Percent|10.0|||||TWO_SIDED||||||||Percent patients overall across all five arms demonstrating complete or partial response by RECIST. No formal statistics performed.|||||
91540244|NCT00189202|182959101|EQUIVALENCE|Equivalence margin 8% plus or minus 4.||||||0.28|||||||Mantel Haenszel|||||||0.28
91540245|NCT00189202|182959102|OTHER|||||||0.7|||||||Kaplan-Meier|||||||0.70
91540246|NCT03506880|182959137|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that drinking would increase from baseline to 12-month follow-up for those in the AC, but not for those in the SG and MADD conditions.||||>0.05
91540247|NCT03506880|182959138|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was also hypothesized that teens in the SG and MADD conditions would report significantly more declining rides with impaired drivers than those in the AC group.||||<0.01
91540248|NCT03506880|182959139|SUPERIORITY||Mean Difference (Final Values)|0.06|||>|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that participants in the MADD and SG groups would be significantly less willing to ride in a car with an impaired driver than those in the AC group.||||>0.01
91540249|NCT02498769|182959157|OTHER||Hazard Ratio (HR)|0.69||||0.18|TWO_SIDED|95.0|0.41|1.19|||Regression, Cox|||||1.19|0.41|0.18
91540250|NCT02498769|182959158|OTHER||Odds Ratio (OR)|0.63||||0.19|TWO_SIDED|95.0|0.31|1.27|||Regression, Logistic|||||1.27|0.31|0.19
91763674|NCT00757237|183417715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61||||0.0048||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.||||0.0048
91540251|NCT02498769|182959159|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||ICU length of stay hours||||.16
91540252|NCT02498769|182959159|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Hospital LOS||||.51
91540253|NCT02498769|182959160|OTHER|||||||0.97|||||||Chi-squared|||||||.97
91540254|NCT04697628|182959163|SUPERIORITY||Cox Proportional Hazard|0.7||||0.0038|TWO_SIDED|95.0|0.54|0.89||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.89|0.54|0.0038
91540255|NCT04697628|182959164|SUPERIORITY||Cox Proportional Hazard|0.67|||<|0.0001|TWO_SIDED|95.0|0.54|0.82||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||HR was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.82|0.54|<0.0001
91540256|NCT04697628|182959165|SUPERIORITY||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|2.1|7.6|||Cochran-Mantel-Haenszel||OR calculated using Cochran-Mantel-Haenszel (CMH) method controlling for stratification factors at randomization.|||7.6|2.1|<0.0001
91540257|NCT01713946|182959219|SUPERIORITY||Odds Ratio (OR)|2.21||||0.008|TWO_SIDED|95.0|1.16|4.2|||Bonferroni-Holm|||||4.20|1.16|0.008
91540258|NCT01713946|182959219|SUPERIORITY||Odds Ratio (OR)|3.93|||<|0.001|TWO_SIDED|95.0|2.1|7.32|||Bonferroni-Holm|||||7.32|2.10|<0.001
91540259|NCT01713946|182959220|SUPERIORITY||Median Difference (Final Values)|15.96||||0.003|TWO_SIDED|95.0|1.98|31.68|||Bonferroni-Holm|||||31.68|1.98|0.003
91540260|NCT01713946|182959220|SUPERIORITY||Odds Ratio (OR)|27.46|||<|0.001|TWO_SIDED|95.0|16.36|43.36|||Bonferroni-Holm|||||43.36|16.36|<0.001
91540261|NCT01713946|182959221|SUPERIORITY||Odds Ratio (OR)|6.55|||||TWO_SIDED|95.0|0.77|55.73||||||||55.73|0.77|
91540262|NCT01713946|182959221|SUPERIORITY||Odds Ratio (OR)|4.99|||||TWO_SIDED|95.0|0.57|44.03||||||||44.03|0.57|
91540263|NCT01713946|182959222|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.05|2.97||||||||2.97|1.05|
91540264|NCT01713946|182959222|SUPERIORITY||Odds Ratio (OR)|3.82|||||TWO_SIDED|95.0|2.25|6.48||||||||6.48|2.25|
91540265|NCT01713946|182959224|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1||||||||3.1|-0.4|
91540266|NCT01713946|182959224|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|2.5|5.9||||||||5.9|2.5|
91540267|NCT01713946|182959225|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.77|2.07||||||||2.07|0.77|
91540268|NCT01713946|182959225|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.74|1.96||||||||1.96|0.74|
91540269|NCT01713946|182959226|SUPERIORITY||Difference in least square means|-1.1|||||TWO_SIDED|95.0|-4.4|2.1||||||||2.1|-4.4|
91540270|NCT01713946|182959226|SUPERIORITY||Difference in least square means|1.0|||||TWO_SIDED|95.0|-2.2|4.3||||||||4.3|-2.2|
91540271|NCT01713946|182959227|SUPERIORITY||Difference in least square means|-2.1|||||TWO_SIDED|95.0|-10.5|6.2||||||||6.2|-10.5|
91763675|NCT00757237|183417716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13||||0.0189||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).||||0.0189
91763676|NCT00757237|183417717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.12||||0.0097||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).||||0.0097
91540272|NCT01713946|182959227|SUPERIORITY||Difference in least square means|0.4|||||TWO_SIDED|95.0|-7.8|8.6||||||||8.6|-7.8|
91540273|NCT01713946|182959228|SUPERIORITY||Difference in least square means|-2.8|||||TWO_SIDED|95.0|-17.9|12.3||||||||12.3|-17.9|
91540274|NCT01713946|182959228|SUPERIORITY||Difference in least square means|-7.7|||||TWO_SIDED|95.0|-22.0|6.6||||||||6.6|-22.0|
91540275|NCT05555082|182959241|OTHER|Single-arm feasibility design; exploratory within-group analysis.|Mean Difference (Final Values)|-3.398||||0.021|TWO_SIDED|95.0|-6.236|-0.559||P-values reported for transparency; feasibility study not powered for hypothesis testing.|Mixed Models Analysis|Linear mixed model with repeated measures; maximum likelihood estimation.|Within-group change from baseline to 12 months|Single-arm feasibility design; exploratory within-group analysis.||-0.559|-6.236|0.021
91540276|NCT05555082|182959241|OTHER||Cohens d|0.66|||||TWO_SIDED|||||||||||||
91540277|NCT05555082|182959242|OTHER|Single-arm feasibility design; exploratory within-group analysis.|Median Difference (Final Values)|-1.328||||0.318|TWO_SIDED|95.0|-4.013|1.357||P-values reported for transparency; study not powered for significance testing.|Mixed Models Analysis|Linear mixed model with repeated measures; maximum likelihood estimation.|Within-group change from baseline to 12 months;|"Single-arm feasibility design; exploratory within-group analysis."||1.357|-4.013|0.318
91540278|NCT05555082|182959242|OTHER||Cohens d|0.29|||||TWO_SIDED|||||||||||||
91540279|NCT05555082|182959243|OTHER|Single-arm feasibility design; exploratory within-group analysis.|Median Difference (Final Values)|-1.453||||0.28|TWO_SIDED|95.0|-4.174|1.268||P-values reported for transparency; study not powered for significance testing.|Mixed Models Analysis|Linear mixed model with repeated measures; maximum likelihood estimation.|Within-group change from baseline to 12 months|"Single-arm feasibility design; exploratory within-group analysis."||1.268|-4.174|0.28
91540280|NCT05555082|182959243|OTHER||Cohens d|0.23|||||TWO_SIDED|||||||||||||
91540281|NCT05555082|182959244|OTHER|Single-arm feasibility design; exploratory within-group analysis.|Median Difference (Final Values)|-2.122||||0.023|TWO_SIDED|95.0|-3.917|-0.326||P-values reported for transparency; study not powered for significance testing.|Mixed Models Analysis|Linear mixed model with repeated measures; maximum likelihood estimation.|Within-group change from baseline to 12 months|"Single-arm feasibility design; exploratory within-group analysis."||-0.326|-3.917|0.023
91540282|NCT05555082|182959244|OTHER||Cohens d|0.57|||||TWO_SIDED|||||||||||||
91540283|NCT05555082|182959245|OTHER|Single-arm feasibility design; exploratory within-group analysis.|Mean Difference (Final Values)|24.876||||0.004|TWO_SIDED|95.0|8.66|41.092||P-values reported for transparency; study not powered for significance testing.|Mixed Models Analysis|Linear mixed model with repeated measures; maximum likelihood estimation.|Within-group change from baseline to 12 months|"Single-arm feasibility design; exploratory within-group analysis."||41.092|8.660|0.004
91540284|NCT05555082|182959245|OTHER||Cohens d|0.96|||||TWO_SIDED|||||||||||||
91540285|NCT03142841|182959289|SUPERIORITY||Slope|-5.06|STANDARD_ERROR_OF_MEAN|1.48||0.001|ONE_SIDED|||||a priori \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.001
91540286|NCT03142841|182959290|SUPERIORITY||Slope|-4.04|STANDARD_ERROR_OF_MEAN|1.69||0.017|TWO_SIDED|||||a priori \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.017
91540287|NCT03142841|182959291|SUPERIORITY||Slope|-4.04|STANDARD_ERROR_OF_MEAN|1.68||0.017|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.017
91540288|NCT03142841|182959292|SUPERIORITY||Slope|-5.66|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis|||||||0.002
91540289|NCT03142841|182959293|SUPERIORITY||Slope|6.47|STANDARD_ERROR_OF_MEAN|4.51||0.152|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.152
91540290|NCT03142841|182959294|SUPERIORITY||Slope|12.53|STANDARD_ERROR_OF_MEAN|4.68||0.008|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.008
91540291|NCT03142841|182959295|SUPERIORITY||Slope|0.66|STANDARD_ERROR_OF_MEAN|2.78||0.812|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.812
91540292|NCT03142841|182959296|SUPERIORITY||Slope|3.64|STANDARD_ERROR_OF_MEAN|3.02||0.229|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.229
91540293|NCT03142841|182959297|SUPERIORITY||Slope|0.21|STANDARD_ERROR_OF_MEAN|5.25||0.968|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.968
91540294|NCT03142841|182959298|SUPERIORITY||Slope|7.24|STANDARD_ERROR_OF_MEAN|5.58||0.196|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.196
91540295|NCT03142841|182959299|SUPERIORITY||Slope|3.46|STANDARD_ERROR_OF_MEAN|1.89||0.067|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.067
91540296|NCT03142841|182959300|SUPERIORITY||Slope|3.98|STANDARD_ERROR_OF_MEAN|2.16||0.066|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.066
91540297|NCT03142841|182959301|SUPERIORITY||Slope|1.99|STANDARD_ERROR_OF_MEAN|1.64||0.225|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.225
91540298|NCT03142841|182959302|SUPERIORITY||Slope|1.93|STANDARD_ERROR_OF_MEAN|1.3||0.138|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.138
91540299|NCT03142841|182959303|SUPERIORITY||Slope|5.17|STANDARD_ERROR_OF_MEAN|1.64||0.002|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.002
91540300|NCT03142841|182959304|SUPERIORITY||Slope|3.12|STANDARD_ERROR_OF_MEAN|1.6||0.052|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.052
91540301|NCT03142841|182959305|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|2.5||0.981|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group X Time Interaction|||||0.981
91540302|NCT03142841|182959306|SUPERIORITY||Slope|3.29|STANDARD_ERROR_OF_MEAN|2.68||0.221|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.221
91540303|NCT03142841|182959307|SUPERIORITY||Slope|-2.35|STANDARD_ERROR_OF_MEAN|1.66||0.159|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.159
91763677|NCT00757237|183417718|SUPERIORITY_OR_OTHER|||||||0.044||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).||||0.044
91540304|NCT03142841|182959308|SUPERIORITY||Slope|-3.13|STANDARD_ERROR_OF_MEAN|1.91||0.103|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.103
91540305|NCT03142841|182959309|SUPERIORITY||Slope|2.84|STANDARD_ERROR_OF_MEAN|2.45||0.247|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.247
91540306|NCT03142841|182959310|SUPERIORITY||Slope|3.43|STANDARD_ERROR_OF_MEAN|2.52||0.174|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.174
91540307|NCT03142841|182959311|SUPERIORITY||Slope|1.73|STANDARD_ERROR_OF_MEAN|2.09||0.408|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.408
91540308|NCT03142841|182959312|SUPERIORITY||Slope|1.53|STANDARD_ERROR_OF_MEAN|2.06||0.457|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.457
91763678|NCT00757237|183417719|SUPERIORITY_OR_OTHER|||||||0.004||0.0||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).||||0.004
91763679|NCT00757237|183417720|SUPERIORITY_OR_OTHER|||||||0.0004||||||No adjustments were made for multiple comparisons.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.||||0.0004
91540309|NCT03142841|182959313|SUPERIORITY||Slope|-2.37|STANDARD_ERROR_OF_MEAN|1.79||0.187|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.187
91540310|NCT03142841|182959314|SUPERIORITY||Slope|-2.0|STANDARD_ERROR_OF_MEAN|1.99||0.315|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.315
91540311|NCT03142841|182959315|SUPERIORITY||Slope|1.49|STANDARD_ERROR_OF_MEAN|1.41||0.289|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.289
91540312|NCT03142841|182959316|SUPERIORITY||Slope|2.92|STANDARD_ERROR_OF_MEAN|1.52||0.055|TWO_SIDED|||||a priori of \<0.05 threshold|Mixed Models Analysis||Group x Time Interaction|||||0.055
91540313|NCT03142841|182959317|OTHER|||||||0.095|||||||Chi-squared|||||||0.095
91540314|NCT03142841|182959318|OTHER|||||||0.6|||||||Chi-squared|||||||0.6
91540315|NCT03142841|182959319|OTHER|||||||0.063|||||||Chi-squared|||||||0.063
91540316|NCT03142841|182959320|OTHER|||||||0.9|||||||Chi-squared|||||||0.9
91540317|NCT03142841|182959321|OTHER|||||||0.15|||||||Chi-squared|||||||0.15
91540318|NCT03142841|182959322|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
91540319|NCT02189252|182959391|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|160.05||||0.2702|TWO_SIDED|95.0|64.71|395.82||The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the first test in the fixed testing sequence.||395.82|64.71|0.2702
91540320|NCT02189252|182959391|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|121.61||||0.6367|TWO_SIDED|95.0|49.17|300.76||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the second test in the fixed testing sequence.||300.76|49.17|0.6367
91540321|NCT02189252|182959392|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|193.91||||0.0511|TWO_SIDED|95.0|99.61|377.47||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the third test in the fixed testing sequence.||377.47|99.61|0.0511
91540322|NCT02189252|182959392|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|133.32||||0.3543|TWO_SIDED|95.0|68.49|259.52||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the fourth test in the fixed testing sequence.||259.52|68.49|0.3543
91540323|NCT02189252|182959393|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|259.19||||0.021|TWO_SIDED|95.0|119.75|560.99|||Mixed Models Analysis|||||560.99|119.75|0.0210
91540324|NCT02189252|182959393|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|177.95||||0.1256|TWO_SIDED|95.0|82.22|385.16|||Mixed Models Analysis|||||385.16|82.22|0.1256
91540325|NCT02189252|182959394|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|298.91||||0.0025|TWO_SIDED|95.0|164.32|543.74||The p-value was only interpreted descriptively|Mixed Models Analysis|||||543.74|164.32|0.0025
91540326|NCT02189252|182959394|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|187.28||||0.0418|TWO_SIDED|95.0|102.95|340.66||The p-value was only interpreted descriptively|Mixed Models Analysis|||||340.66|102.95|0.0418
91540327|NCT02189252|182959395|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|79.36||||0.6833|TWO_SIDED|95.0|22.95|274.45|||Mixed Models Analysis|||||274.45|22.95|0.6833
91540328|NCT02189252|182959395|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|69.39||||0.522|TWO_SIDED|95.0|20.07|239.98|||Mixed Models Analysis|||||239.98|20.07|0.5220
91540329|NCT02189252|182959396|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.78||||0.9034|TWO_SIDED|95.0|44.92|244.41|||Mixed Models Analysis|||||244.41|44.92|0.9034
91540330|NCT02189252|182959396|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|80.58||||0.5782||95.0|34.55|187.95|||Mixed Models Analysis|||||187.95|34.55|0.5782
91540331|NCT02189252|182959397|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|753.75||||0.0391|TWO_SIDED|95.0|112.03|5071.6|||Mixed Models Analysis|||||5071.6|112.03|0.0391
91540332|NCT02189252|182959397|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.98||||0.9578|TWO_SIDED|95.0|15.6|706.33|||Mixed Models Analysis|||||706.33|15.60|0.9578
91540333|NCT02189252|182959398|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|376.64||||0.0186|TWO_SIDED|95.0|128.55|1103.5|||Mixed Models Analysis|||||1103.5|128.55|0.0186
91540334|NCT02189252|182959398|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|131.74||||0.5955|TWO_SIDED|95.0|44.97|386.0|||Mixed Models Analysis|||||386.00|44.97|0.5955
91540335|NCT04396860|182959399|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.96|TWO_SIDED|95.0|0.98|2.21|||Log Rank|Stratified log-rank|Reference level = Arm 1|For the phase II endpoint, observation of 100 PFS events among the 150 randomized patients (from both arms) provides 95% statistical power to detect an improvement in median PFS from 5.7 months in the control arm to 9.7 months in the experimental arm, corresponding to a hazard reduction of 42% (hazard ratio 0.58) at one-sided significance level of 0.15 (and 87% power for hazard ratio of 0.65 at this same alpha).||2.21|0.98|0.96
91540336|NCT01040689|182959418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.145|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.224|0.145|<0.0001
91540337|NCT01040689|182959418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.167|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.246|0.167|<0.0001
91540338|NCT01040689|182959418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.133|0.212|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.212|0.133|<0.0001
91540339|NCT01040689|182959419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.09|0.173|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.173|0.090|<0.0001
91540340|NCT01040689|182959419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.219|0.136|<0.0001
91540341|NCT01040689|182959419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.081|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.164|0.081|<0.0001
91540342|NCT01040689|182959420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.121|0.196|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.196|0.121|<0.0001
91540343|NCT01040689|182959420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.23|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.230|0.155|<0.0001
91540344|NCT01040689|182959420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.110|<0.0001
91540345|NCT01040689|182959421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.147|0.216|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.216|0.147|<0.0001
91540346|NCT01040689|182959421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.178|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.247|0.178|<0.0001
91540347|NCT01040689|182959421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.097|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.167|0.097|<0.0001
91540348|NCT01040689|182959422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.17|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.243|0.170|<0.0001
91540349|NCT01040689|182959422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.179|0.252|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.252|0.179|<0.0001
91540350|NCT01040689|182959422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.146|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.219|0.146|<0.0001
91540351|NCT01040689|182959423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.177|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.249|0.177|<0.0001
91540352|NCT01040689|182959423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.203|0.275|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.275|0.203|<0.0001
91540353|NCT01040689|182959423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.125|0.197|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.197|0.125|<0.0001
91540354|NCT01040689|182959424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.168|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.258|0.168|<0.0001
91540355|NCT01040689|182959424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.189|0.279|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.279|0.189|<0.0001
91763680|NCT01843023|183417722|SUPERIORITY||Mean Difference (Final Values)|0.558|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91540356|NCT01040689|182959424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.156|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.246|0.156|<0.0001
91540357|NCT01040689|182959425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.096|0.17|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.170|0.096|<0.0001
91540358|NCT01040689|182959425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.184|0.110|<0.0001
91540359|NCT01040689|182959425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.06|0.134|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.134|0.060|<0.0001
91540360|NCT01040689|182959426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.216|0.348|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.348|0.216|<0.0001
91540361|NCT01040689|182959426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.237|0.368|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.368|0.237|<0.0001
91540362|NCT01040689|182959426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.21|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.342|0.210|<0.0001
91763681|NCT01843023|183417724|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91540363|NCT01040689|182959427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.131|0.262|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.262|0.131|<0.0001
91540364|NCT01040689|182959427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.187|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.318|0.187|<0.0001
91763682|NCT01397461|183417728|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison"||||0.003
91763683|NCT02204072|183417786|OTHER||Hazard Ratio (HR)|0.98||||0.9549|TWO_SIDED|95.0|0.57|1.7|||Two-sided log-rank test.||Cox proportional hazard model. Hazard ratio: Comparison vs Enzalutamide|||1.70|0.57|0.9549
91540365|NCT01040689|182959427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.118|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.249|0.118|<0.0001
91540366|NCT01040689|182959428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.178|0.301|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.301|0.178|<0.0001
91540367|NCT01040689|182959428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.216|0.339|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.339|0.216|<0.0001
91540368|NCT01040689|182959428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.168|0.291|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.291|0.168|<0.0001
91540369|NCT01040689|182959429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.207|0.33|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.330|0.207|<0.0001
91540370|NCT01040689|182959429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.251|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.374|0.251|<0.0001
91540371|NCT01040689|182959429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.153|0.277|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.277|0.153|<0.0001
91540372|NCT01040689|182959430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.246|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.388|0.246|<0.0001
91540373|NCT01040689|182959430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.247|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.388|0.247|<0.0001
91763684|NCT02204072|183417789|OTHER||Hazard Ratio (HR)|1.19||||0.5425|TWO_SIDED|95.0|0.68|2.06|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzaludamide.|||2.06|0.68|0.5425
91540374|NCT01040689|182959430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.231|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.231|<0.0001
91540375|NCT01040689|182959431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.222|0.378|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.378|0.222|<0.0001
91540376|NCT01040689|182959431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.22|0.375|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.375|0.220|<0.0001
91540377|NCT01040689|182959431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.217|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.217|<0.0001
91540378|NCT01040689|182959432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.115|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.255|0.115|<0.0001
91540379|NCT01040689|182959432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.143|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.143|<0.0001
91540380|NCT01040689|182959432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.036||0.0003||95.0|0.059|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.059|0.0003
91540381|NCT04147897|182959434|SUPERIORITY||Difference in Difference|1.5||||0.06|TWO_SIDED||||||adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.28|||.06
91763685|NCT02204072|183417790|OTHER||Hazard Ratio (HR)|1.16||||0.5534|TWO_SIDED|95.0|0.71|1.9|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.90|0.71|0.5534
91763686|NCT02204072|183417791|OTHER||Hazard Ratio (HR)|0.64||||0.1514|TWO_SIDED|95.0|0.35|1.18|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.18|0.35|0.1514
91763687|NCT02204072|183417795|OTHER||Odds Ratio (OR)|1.579||||0.6186|TWO_SIDED|95.0|0.269|12.515|||Regression, Logistic|Odds ratio, p-value and confidence interval were obtained from logistic regression model.||||12.515|0.269|0.6186
91540382|NCT04147897|182959434|SUPERIORITY||Difference-in-Difference|1.0||||0.25|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.19|||.25
91540383|NCT04147897|182959435|SUPERIORITY||difference in difference|0.7||||0.37|TWO_SIDED||||||adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.13|||0.37
91540384|NCT04147897|182959435|SUPERIORITY||Difference-in-Difference|0.6||||0.44|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.13|||.44
91540385|NCT04147897|182959436|SUPERIORITY||Difference-in-Difference|-0.4||||0.619|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: -0.07|||.619
91540386|NCT04147897|182959436|SUPERIORITY||Difference-in-Difference|1.5||||0.1|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.26|||0.10
91540387|NCT04147897|182959437|SUPERIORITY||Difference-in-Difference|1.9||||0.32|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.15|||.32
91540388|NCT04147897|182959437|SUPERIORITY||Difference-in-Difference|3.0||||0.16|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.23|||0.16
91540389|NCT04147897|182959438|SUPERIORITY||Difference-in-Difference|1.1||||0.31|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.15|||.31
91540390|NCT04147897|182959438|SUPERIORITY||Difference-in-Difference|1.3||||0.28|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.17|||.28
91540391|NCT04147897|182959439|SUPERIORITY||Difference-in-Difference|0.5||||0.63|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.07|||.63
91540392|NCT04147897|182959439|SUPERIORITY||Difference-in-Difference|0.9||||0.46|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.12|||.46
91540393|NCT04147897|182959440|SUPERIORITY||Difference-in-Difference|-0.4||||0.67|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 3 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: -0.07|||0.67
91540394|NCT04147897|182959440|SUPERIORITY||Difference-in-Difference|0.7||||0.53|TWO_SIDED||||||Adjusted mixed-effects linear regression|||Mixed-effects linear models were used to analyze within-person changes from baseline to 6 months, accounting for repeated measures within participants and clustering of patients within agencies. Difference-in-differences estimates were derived to compare EF vs IF, with Cohen's d effect sizes calculated for each contrast.|Cohen's d: 0.10|||0.53
91540395|NCT05764161|182959441|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5859|TWO_SIDED|95.0|0.651|2.143|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||2.143|0.651|0.5859
91540396|NCT05764161|182959441|SUPERIORITY||Response Rate Difference|3.81|STANDARD_ERROR_OF_MEAN|6.966|||TWO_SIDED|95.0|-9.84|17.46||||||||17.46|-9.84|
91540397|NCT05764161|182959442|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0741|TWO_SIDED|95.0|0.938|3.683|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||3.683|0.938|0.0741
91540398|NCT05764161|182959442|SUPERIORITY||Response Rate Difference|11.15|STANDARD_ERROR_OF_MEAN|6.162|||TWO_SIDED|95.0|-0.93|23.23||||||||23.23|-0.93|
91540399|NCT05764161|182959443|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1493|TWO_SIDED|95.0|0.75|5.74|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||5.740|0.750|0.1493
91540400|NCT05764161|182959443|SUPERIORITY||Response Rate Difference|6.17|STANDARD_ERROR_OF_MEAN|4.257|||TWO_SIDED|95.0|-2.18|14.51||||||||14.51|-2.18|
91540401|NCT05764161|182959444|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0142|TWO_SIDED|95.0|1.193|6.033|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||6.033|1.193|0.0142
91540402|NCT05764161|182959444|SUPERIORITY||Response Rate Difference|13.46|STANDARD_ERROR_OF_MEAN|5.384|||TWO_SIDED|95.0|2.9|24.01||||||||24.01|2.90|
91540403|NCT05764161|182959445|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0387|TWO_SIDED|95.0|1.06|8.897|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by IGA-CPG-S score (2 or ≥3) and geographic region (North America or outside of North America).||||8.897|1.060|0.0387
91540404|NCT05764161|182959445|SUPERIORITY||Response Rate Difference|9.49|STANDARD_ERROR_OF_MEAN|4.343|||TWO_SIDED|95.0|0.98|18.0||||||||18.00|0.98|
91540405|NCT05764161|182959447|SUPERIORITY||Least squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.244||0.0005|TWO_SIDED|95.0|-1.35|-0.39|||Mixed Model for Repeated Measures (MMRM)|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||-0.39|-1.35|0.0005
91540406|NCT05764161|182959447|SUPERIORITY||Least squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.303||0.0007|TWO_SIDED|95.0|-1.64|-0.45|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||-0.45|-1.64|0.0007
91540407|NCT05764161|182959447|SUPERIORITY||Least squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.367||0.0036|TWO_SIDED|95.0|-1.81|-0.36|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||-0.36|-1.81|0.0036
91540408|NCT05764161|182959447|SUPERIORITY||Least squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.396||0.0287|TWO_SIDED|95.0|-1.65|-0.09|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||-0.09|-1.65|0.0287
91540409|NCT05764161|182959449|SUPERIORITY||Hazard Ratio (HR)|1.783||||0.0005|TWO_SIDED|95.0|1.288|2.468|||Log Rank|Log-rank test stratified by randomization stratification factors between treatment and vehicle.|Cox regression model stratified by stratification factors (Baseline IGA 2/3, Region North America/ Outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.468|1.288|0.0005
91540410|NCT05764161|182959450|SUPERIORITY||Hazard Ratio (HR)|1.477||||0.0399|TWO_SIDED|95.0|1.015|2.15|||Log Rank|Log-rank test stratified by randomization stratification factors between treatment and vehicle.|Cox regression model stratified by stratification factors (Baseline IGA 2/3, Region North America/ Outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.150|1.015|0.0399
91763688|NCT02204072|183417797|OTHER||Odds Ratio (OR)|1.891||||0.192|TWO_SIDED|95.0|0.727|5.059|||Regression, Logistic||Odds ratio, p-value and confidence interval were obtained from logistic regression model.|||5.059|0.727|0.1920
91763689|NCT00367835|183417837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91763690|NCT00367835|183417838|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91540411|NCT05764161|182959453|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.249||0.0016|TWO_SIDED|95.0|-1.29|-0.31|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||-0.31|-1.29|0.0016
91540412|NCT05764161|182959453|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.32||0.0071|TWO_SIDED|95.0|-1.51|-0.24|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||-0.24|-1.51|0.0071
91540413|NCT05764161|182959453|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.369||0.0198|TWO_SIDED|95.0|-1.6|-0.14|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||-0.14|-1.60|0.0198
91540414|NCT05764161|182959453|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.403||0.1384|TWO_SIDED|95.0|-1.4|0.2|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||0.20|-1.40|0.1384
91540415|NCT05764161|182959459|SUPERIORITY||Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.744||0.0759|TWO_SIDED|95.0|-2.8|0.14|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||0.14|-2.80|0.0759
91540416|NCT05764161|182959459|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.809||0.1447|TWO_SIDED|95.0|-2.78|0.41|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||0.41|-2.78|0.1447
91540417|NCT05764161|182959459|SUPERIORITY||Least Squares Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.9||0.3395|TWO_SIDED|95.0|-2.64|0.91|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||0.91|-2.64|0.3395
91540418|NCT05764161|182959459|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.943||0.4794|TWO_SIDED|95.0|-2.53|1.19|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||1.19|-2.53|0.4794
91540419|NCT05764161|182959461|SUPERIORITY||Least Squares Mean Difference|2.59|STANDARD_ERROR_OF_MEAN|2.522||0.3053|TWO_SIDED|95.0|-2.38|7.57|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 2||7.57|-2.38|0.3053
91540420|NCT05764161|182959461|SUPERIORITY||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|2.45||0.3893|TWO_SIDED|95.0|-2.72|6.95|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 4||6.95|-2.72|0.3893
91763691|NCT00367835|183417839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91763692|NCT00367835|183417840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91763693|NCT00367835|183417841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
91763694|NCT00367835|183417842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||ANCOVA|||||||0.002
91763695|NCT00367835|183417843|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91763696|NCT03453489|183417849|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
91763697|NCT04346654|183417852|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
91763698|NCT04346654|183417853|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
91763699|NCT00999518|183417877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.4|0.35||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).||0.35|-0.40|
91540421|NCT05764161|182959461|SUPERIORITY||Least Squares Mean Difference|2.82|STANDARD_ERROR_OF_MEAN|2.371||0.2357|TWO_SIDED|95.0|-1.86|7.5|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 8||7.50|-1.86|0.2357
91540422|NCT05764161|182959461|SUPERIORITY||Least Squares Mean Difference|1.41|STANDARD_ERROR_OF_MEAN|2.567||0.5839|TWO_SIDED|95.0|-3.66|6.47|||Mixed Model for Repeated Measures|MMRM model: (Response Variable = Treatment + Stratification Factors \[IGA-CPG-S/Region\] + Visit + Treatment\*Visit)||Week 12||6.47|-3.66|0.5839
91540423|NCT00588770|182959519|SUPERIORITY|||||||0.22||||||The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.|Log Rank|||The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.||||0.22
91540424|NCT02115282|182959538|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3|TWO_SIDED|95.0|0.67|1.13||The p value was based on stratified log rank test, the threshold for significance was two-sided p value of 0.2%.|Log Rank|||||1.13|0.67|0.30
91540425|NCT02115282|182959539|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.82|1.21||The p value was based on stratified log rank test, stratified on the four randomization factors. The threshold for statistical significance was two-sided p value of 3.7% after taking into account the five interim analyses of OS into account.|Log Rank|||||1.21|0.82|0.94
91540426|NCT05797155|182959584|SUPERIORITY||Odds Ratio (OR)|1.66||||0.036|TWO_SIDED|95.0|1.04|2.67|||Regression, Logistic||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio).|This is a cross sectional analysis at 1-month.||2.67|1.04|.036
91540427|NCT05797155|182959584|SUPERIORITY||Odds Ratio (OR)|1.11||||0.632|TWO_SIDED|95.0|0.72|1.72|||Regression, Logistic||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio).|This is a cross sectional analysis at 3-months||1.72|0.72|.632
91540428|NCT05797155|182959585|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.08||0.437|TWO_SIDED||||||t-test, 2 sided||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the condition by time interaction).|This is a longitudinal analysis from baseline to 3-month follow-up||||.437
91763700|NCT00999518|183417877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.8|0.68||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.68|-0.80|
91763701|NCT00999518|183417877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.15|0.83||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.83|-1.15|
91540429|NCT05797155|182959586|SUPERIORITY||Odds Ratio (OR)|1.51||||0.088|TWO_SIDED|95.0|0.94|2.42|||Regression, Logistic||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio).|This is a cross sectional analysis at 1-month||2.42|0.94|.088
91540430|NCT05797155|182959586|SUPERIORITY||Odds Ratio (OR)|1.15||||0.646|TWO_SIDED|95.0|0.64|2.07|||Regression, Logistic||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio).|This is a cross sectional analysis at 3-months||2.07|0.64|.646
91540431|NCT05797155|182959587|SUPERIORITY||Odds Ratio (OR)|1.77||||0.01|TWO_SIDED|95.0|1.15|2.72|||Regression, Logistic||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio).|This is a cross sectional analysis at 1-month||2.72|1.15|.010
91763702|NCT00999518|183417877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.93|0.47||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.47|-0.93|
91763703|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.259|1.683||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.683|0.259|
91763704|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.975|||||TWO_SIDED|95.0|0.387|2.457||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.457|0.387|
91540432|NCT05797155|182959587|SUPERIORITY||Odds Ratio (OR)|1.36||||0.158|TWO_SIDED|95.0|0.89|2.11|||Regression, Logistic||The Support2Quit group was scored 1 and the Comparison group was scored 0 (reference group for the odds ratio).|This is a cross sectional analysis at 3-months||2.11|0.89|.158
91540433|NCT03617263|182959588|SUPERIORITY|||||||0.0613|||||||ANCOVA|||||||0.0613
91540434|NCT03617263|182959589|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Week 12||||<.0001
91540435|NCT03617263|182959589|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Week 24||||<.0001
91540436|NCT03617263|182959590|SUPERIORITY|||||||0.0142|||||||ANCOVA|||Week 12||||0.0142
91540437|NCT03617263|182959590|SUPERIORITY|||||||0.0077|||||||ANCOVA|||Week 24||||0.0077
91540438|NCT03617263|182959591|SUPERIORITY|||||||0.2893|||||||ANCOVA|||Week 12||||0.2893
91540439|NCT03617263|182959591|SUPERIORITY|||||||0.1989|||||||ANCOVA|||Week 24||||0.1989
91540440|NCT03617263|182959592|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Week 12||||<.0001
91540441|NCT03617263|182959592|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Week 24||||<.0001
91540442|NCT03617263|182959593|SUPERIORITY|||||||0.8664|||||||ANCOVA|||Week 12||||0.8664
91540443|NCT03617263|182959593|SUPERIORITY|||||||0.1137|||||||ANCOVA|||Week 24||||0.1137
91540444|NCT03617263|182959594|SUPERIORITY|||||||0.0487|||||||ANCOVA|||Week 12||||0.0487
91540445|NCT03617263|182959594|SUPERIORITY|||||||0.7743|||||||ANCOVA|||Week 24||||0.7743
91540446|NCT03617263|182959595|SUPERIORITY|||||||0.1174|||||||ANCOVA|||Week 12||||0.1174
91540447|NCT03617263|182959595|SUPERIORITY|||||||0.1483|||||||ANCOVA|||Week 24||||0.1483
91763705|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
91763706|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
91763707|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.629|||||TWO_SIDED|95.0|0.202|1.96||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.960|0.202|
91763708|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.179|||||TWO_SIDED|95.0|0.411|3.376||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.376|0.411|
91763709|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.222|||||TWO_SIDED|95.0|0.438|3.414||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.414|0.438|
91540448|NCT03617263|182959596|SUPERIORITY|||||||0.0941|||||||ANCOVA|||Week 12||||0.0941
91540449|NCT03617263|182959596|SUPERIORITY|||||||0.2378|||||||ANCOVA|||Week 24||||0.2378
91540450|NCT03617263|182959597|SUPERIORITY|||||||0.1542|||||||ANCOVA|||CK-18 Fragment - M30||||0.1542
91540451|NCT03617263|182959597|SUPERIORITY|||||||0.2037|||||||ANCOVA|||CK-18 Fragment - M65||||0.2037
91540452|NCT03617263|182959598|SUPERIORITY|||||||0.4431|||||||ANCOVA|||||||0.4431
91540453|NCT03617263|182959599|SUPERIORITY|||||||0.2289|||||||ANCOVA|||||||0.2289
91763710|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.778|||||TWO_SIDED|95.0|0.259|2.335||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.335|0.259|
91763711|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.929|||||TWO_SIDED|95.0|0.37|2.327||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.327|0.370|
91763712|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.083|||||TWO_SIDED|95.0|0.427|2.749||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.749|0.427|
91540454|NCT03617263|182959600|SUPERIORITY|||||||0.0853|||||||ANCOVA|||||||0.0853
91540455|NCT03617263|182959601|SUPERIORITY|||||||0.2559|||||||ANCOVA|||||||0.2559
91540456|NCT03617263|182959602|SUPERIORITY|||||||0.68|||||||ANCOVA|||Week 12||||0.6800
91763713|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
91763714|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
91763715|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.875|||||TWO_SIDED|95.0|0.285|2.682||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.682|0.285|
91540457|NCT03617263|182959602|SUPERIORITY|||||||0.4587|||||||ANCOVA|||Week 24||||0.4587
91540458|NCT03617263|182959603|SUPERIORITY|||||||0.923|||||||ANCOVA|||Week 12||||0.9230
91540459|NCT03617263|182959603|SUPERIORITY|||||||0.7115|||||||ANCOVA|||Week 24||||0.7115
91540460|NCT03617263|182959604|SUPERIORITY|||||||0.1983|||||||ANCOVA|||||||0.1983
91540461|NCT03617263|182959605|SUPERIORITY|||||||0.7576|||||||ANCOVA|||||||0.7576
91540462|NCT03617263|182959606|SUPERIORITY|||||||0.2784|||||||ANCOVA|||Week 12||||0.2784
91540463|NCT03617263|182959606|SUPERIORITY|||||||0.0091|||||||ANCOVA|||Week 24||||0.0091
91540464|NCT03617263|182959607|SUPERIORITY|||||||0.0941|||||||ANCOVA|||Week 12||||0.0941
91540465|NCT03617263|182959607|SUPERIORITY|||||||0.0009|||||||ANCOVA|||||||0.0009
91540466|NCT03617263|182959608|SUPERIORITY|||||||0.1363|||||||ANCOVA|||Week 12||||0.1363
91540467|NCT03617263|182959608|SUPERIORITY|||||||0.3057|||||||ANCOVA|||Week 24||||0.3057
91540468|NCT03617263|182959609|SUPERIORITY|||||||0.3323|||||||ANCOVA|||Week 12||||0.3323
91540469|NCT03617263|182959609|SUPERIORITY|||||||0.0624|||||||ANCOVA|||Week 24||||0.0624
91540470|NCT03617263|182959610|SUPERIORITY|||||||0.505|||||||ANCOVA|||Week 12||||0.5050
91540471|NCT03617263|182959610|SUPERIORITY|||||||0.0279|||||||ANCOVA|||Week 24||||0.0279
91540472|NCT03617263|182959611|SUPERIORITY|||||||0.3508|||||||ANCOVA|||Week 12||||0.3508
91540473|NCT03617263|182959611|SUPERIORITY|||||||0.0059|||||||ANCOVA|||Week 24||||0.0059
91540474|NCT03617263|182959612|SUPERIORITY|||||||0.68|||||||ANCOVA|||Week 12||||0.6800
91540475|NCT03617263|182959612|SUPERIORITY|||||||0.731|||||||ANCOVA|||Week 24||||0.7310
91540476|NCT03617263|182959613|SUPERIORITY|||||||0.0896|||||||ANCOVA|||Week 12||||0.0896
91540477|NCT03617263|182959613|SUPERIORITY|||||||0.0053|||||||ANCOVA|||Week 24||||0.0053
91540478|NCT03617263|182959614|SUPERIORITY|||||||0.5962|||||||ANCOVA|||Week 12||||0.5962
91540479|NCT03617263|182959614|SUPERIORITY|||||||0.3035|||||||ANCOVA|||Week 24||||0.3035
91540480|NCT03617263|182959615|SUPERIORITY|||||||0.3482|||||||ANCOVA|||Week 12||||0.3482
91540481|NCT03617263|182959615|SUPERIORITY|||||||0.4176|||||||ANCOVA|||Week 24||||0.4176
91540482|NCT03617263|182959616|SUPERIORITY|||||||0.993|||||||ANCOVA|||||||0.9930
91540483|NCT03617263|182959616|SUPERIORITY|||||||0.3612|||||||ANCOVA|||Week 24||||0.3612
91540484|NCT03617263|182959617|SUPERIORITY|||||||0.4373|||||||ANCOVA|||Week 12||||0.4373
91540485|NCT03617263|182959617|SUPERIORITY|||||||0.6248|||||||ANCOVA|||Week 24||||0.6248
91540486|NCT03617263|182959618|SUPERIORITY|||||||0.0994|||||||ANCOVA|||Week 12||||0.0994
91540487|NCT03617263|182959618|SUPERIORITY|||||||0.3527|||||||ANCOVA|||Week 24||||0.3527
91540488|NCT03617263|182959619|SUPERIORITY|||||||0.7065|||||||ANCOVA|||Week 12||||0.7065
91540489|NCT03617263|182959619|SUPERIORITY|||||||0.4096|||||||ANCOVA|||Week 24||||0.4096
91540490|NCT03617263|182959620|SUPERIORITY|||||||0.2475|||||||ANCOVA|||Week 12||||0.2475
91763716|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.366|||||TWO_SIDED|95.0|0.466|4.006||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||4.006|0.466|
91540491|NCT03617263|182959620|SUPERIORITY|||||||0.1621|||||||ANCOVA|||Week 24||||0.1621
91540492|NCT03617263|182959621|SUPERIORITY|||||||0.5862|||||||ANCOVA|||Week 12||||0.5862
91540493|NCT03617263|182959621|SUPERIORITY|||||||0.2026|||||||ANCOVA|||Week 24||||0.2026
91540494|NCT03617263|182959622|SUPERIORITY|||||||0.6434|||||||ANCOVA|||Week 12||||0.6434
91540495|NCT03617263|182959622|SUPERIORITY|||||||0.9895|||||||ANCOVA|||Week 24||||0.9895
91540496|NCT00762619|182959646|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763717|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.235|2.394||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.394|0.235|
91763718|NCT00999518|183417879|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.063|||||TWO_SIDED|95.0|0.356|3.168||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.168|0.356|
91540497|NCT00762619|182959647|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540498|NCT00762619|182959648|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540499|NCT00762619|182959649|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540500|NCT00762619|182959650|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540501|NCT00762619|182959651|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540502|NCT00762619|182959652|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540503|NCT00762619|182959653|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540504|NCT00762619|182959654|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540505|NCT00762619|182959655|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540506|NCT00762619|182959656|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763719|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.263||||0.5731|TWO_SIDED|95.0|0.56|2.848|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.848|0.560|0.5731
91540507|NCT00762619|182959657|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540508|NCT00762619|182959658|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540509|NCT00762619|182959659|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540510|NCT00762619|182959660|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540511|NCT00762619|182959661|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540512|NCT00762619|182959662|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540513|NCT00762619|182959663|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540514|NCT00762619|182959664|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540515|NCT00762619|182959665|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540516|NCT00762619|182959666|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540517|NCT00762619|182959667|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540518|NCT00762619|182959668|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540519|NCT00762619|182959669|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540520|NCT00762619|182959670|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540521|NCT00762619|182959671|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540522|NCT00762619|182959672|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540523|NCT00762619|182959673|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540524|NCT00762619|182959674|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540525|NCT00762619|182959675|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540526|NCT00762619|182959676|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540527|NCT00762619|182959677|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540528|NCT00762619|182959678|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540529|NCT00762619|182959679|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540530|NCT00762619|182959680|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763720|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.656||||0.2592|TWO_SIDED|95.0|0.689|3.98|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||3.980|0.689|0.2592
91540531|NCT00762619|182959681|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540532|NCT00762619|182959682|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763721|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9181||||1.045|TWO_SIDED|95.0|0.452|2.417|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.417|0.452|1.045
91763722|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.306||||0.5289|TWO_SIDED|95.0|0.569|2.997|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.997|0.569|0.5289
91763723|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.893||||0.793|TWO_SIDED|95.0|0.385|2.074|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.074|0.385|0.7930
91763724|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.167||||0.7386|TWO_SIDED|95.0|0.471|2.892|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.892|0.471|0.7386
91763725|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.9354|TWO_SIDED|95.0|0.437|2.46|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.460|0.437|0.9354
91763726|NCT00999518|183417882|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.805||||0.6207|TWO_SIDED|95.0|0.341|1.899|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||1.899|0.341|0.6207
91763727|NCT02178696|183417925|OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.31|<|0.001|TWO_SIDED|95.0|0.016|0.23||A p\<0.001 was established for regions a priori hypothesized (e.g. nucleus accumbens).|t-test, 2 sided|||||0.23|0.016|<0.001
91763728|NCT01101035|183418051|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.359 (75% interim) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|0.99|||||ONE_SIDED|97.0||1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23||
91763729|NCT01101035|183418052|OTHER||Cox Proportional Hazard|1.09|||||TWO_SIDED|95.0|0.92|1.28|||||Time from randomization to the first occurrence of any APTC event was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function status as a stratification factor.|||1.28|0.92|
91540533|NCT00762619|182959683|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540534|NCT00762619|182959684|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540535|NCT00762619|182959685|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540536|NCT00762619|182959686|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540537|NCT00762619|182959687|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763730|NCT01101035|183418053|OTHER||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.73|||||Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.73|1.03|
91540538|NCT00762619|182959688|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540539|NCT00762619|182959689|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540540|NCT00762619|182959690|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540541|NCT00762619|182959691|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540542|NCT00762619|182959692|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763731|NCT01101035|183418054|OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.21|0.72|
91540543|NCT00762619|182959693|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540544|NCT00762619|182959694|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540545|NCT00762619|182959695|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540546|NCT00762619|182959696|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540547|NCT00762619|182959697|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540548|NCT00762619|182959698|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540549|NCT00762619|182959699|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540550|NCT00762619|182959700|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540551|NCT00762619|182959701|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763732|NCT01101035|183418055|OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.73|1.41|||||Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.41|0.73|
91540552|NCT00762619|182959702|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540553|NCT00762619|182959703|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540554|NCT00762619|182959704|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540555|NCT00762619|182959705|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540556|NCT00762619|182959706|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540557|NCT00762619|182959707|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540558|NCT00762619|182959708|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91763733|NCT01101035|183418056|OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.59|1.26|||||Time from randomization to the first occurrence of unstable angina with urgent coronary revascularization was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.26|0.59|
91540559|NCT00762619|182959709|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540560|NCT00762619|182959710|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540561|NCT00762619|182959711|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540562|NCT00762619|182959712|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540563|NCT00762619|182959713|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91540564|NCT01350804|182959716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0458|TWO_SIDED|95.0|1.0|3.2|||Regression, Logistic|||||3.2|1.0|0.0458
91540565|NCT01350804|182959716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.0152|TWO_SIDED|95.0|1.1|3.5|||Regression, Logistic|||||3.5|1.1|0.0152
91540566|NCT05793112|182959732|SUPERIORITY||Median Difference (Final Values)|57.57||||0.154|||||||Wilcoxon range sum test|||||||0.154
91540567|NCT05793112|182959733|SUPERIORITY||Median Difference (Final Values)|-5.0||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
91540568|NCT05793112|182959734|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.471|||||||Fisher Exact|||||||0.471
91540569|NCT05793112|182959735|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||Day 0 (Baseline)||||0.057
91540570|NCT05793112|182959735|SUPERIORITY|||||||0.169|||||||Cochran-Mantel-Haenszel|||Day 7||||0.169
91540571|NCT05793112|182959735|SUPERIORITY|||||||0.168|||||||Cochran-Mantel-Haenszel|||Day 14||||0.168
91540572|NCT05793112|182959735|SUPERIORITY|||||||0.139|||||||Cochran-Mantel-Haenszel|||Day 21||||0.139
91540573|NCT05793112|182959735|SUPERIORITY|||||||0.348|||||||Cochran-Mantel-Haenszel|||Day 28||||0.348
91540574|NCT05777785|182959742|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|0.9789||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
91540575|NCT05777785|182959744|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.027|TWO_SIDED||||||t-test, 2 sided|||||||0.027
91540576|NCT05777785|182959745|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.029|TWO_SIDED||||||t-test, 2 sided|||||||0.029
91540577|NCT00304031|182959746|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.63|TWO_SIDED|95.0|0.88|1.2||One-sided|Log Rank||Reference level = Conventional adjuvant TMZ|This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).||1.20|0.88|0.63
91540578|NCT00304031|182959747|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.06|TWO_SIDED|95.0|0.75|1.0||Two-side significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|||1.00|0.75|0.06
91540579|NCT00304031|182959748|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.44|TWO_SIDED|95.0|0.82|1.19||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.19|0.82|0.44
91540580|NCT00304031|182959748|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.86|TWO_SIDED|95.0|0.87|1.62||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.62|0.87|0.86
91540581|NCT00304031|182959749|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.0|0.73|1.05||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.05|0.73|0.15
91763734|NCT01101035|183418057|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.014 (final analysis) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|1.03|||||TWO_SIDED|97.0|0.87|1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23|0.87|
91763735|NCT00797277|183418091|NON_INFERIORITY_OR_EQUIVALENCE|There was no previous study comparing these 2 treatments. We hypothesized that the mean difference between the 2 treatments would be small.|Mean Difference (Final Values)|1.0|||<|0.05|||||||t-test, 2 sided|||we hypothesized that there would be no statistical significant difference between the 2 groups in the primary outcome.||||<0.05
91763736|NCT01957202|183418095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.255|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.616|||Mixed Model ANOVA|||||-1.616|-2.895|<0.0001
91540582|NCT00304031|182959749|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.33|TWO_SIDED|95.0|0.66|1.15||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.15|0.66|0.33
91540583|NCT00304031|182959750|SUPERIORITY|||||||0.012||||||Two-sided significance level of 0.05|Chi-squared|||||||0.012
91540584|NCT00304031|182959751|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided significance level of 0.05||||||<0.001
91540585|NCT00304031|182959752|SUPERIORITY||||||<|0.001||||||Two-sided test|Log Rank|||||||<0.001
91540586|NCT00304031|182959753|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
91540587|NCT00304031|182959754|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
91540588|NCT00304031|182959755|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
91763737|NCT01957202|183418095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.566|||<|0.0001|TWO_SIDED|95.0|-3.208|-1.925|||Mixed Model ANOVA|||||-1.925|-3.208|<0.0001
91540589|NCT00304031|182959756|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
91540590|NCT00304031|182959757|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91540591|NCT00304031|182959758|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
91540592|NCT00304031|182959759|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91540593|NCT00304031|182959760|SUPERIORITY|||||||0.2184|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2184
91763738|NCT01957202|183418095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.531||||0.0003|TWO_SIDED|95.0|-2.342|-0.719|||Mixed Model ANOVA|||||-0.719|-2.342|0.0003
91540594|NCT00304031|182959760|SUPERIORITY|||||||0.0763|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.||||0.0763
91540595|NCT00304031|182959760|SUPERIORITY|||||||0.5235|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.5235
91540596|NCT00304031|182959761|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
91540597|NCT00304031|182959762|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
91540598|NCT00304031|182959763|SUPERIORITY|||||||0.0002|||||||Chi-squared|Two-sided test||||||0.0002
91540599|NCT00304031|182959764|SUPERIORITY|||||||0.005|||||||Fisher Exact|Two-sided test||||||0.005
91540600|NCT00304031|182959765|SUPERIORITY|||||||0.018|||||||Fisher Exact|Two-sided test||||||0.018
91540601|NCT00304031|182959766|SUPERIORITY|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||||||0.1702|||||||Mixed Models Analysis|||A mixed effects model was run with MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.1702
91540602|NCT00304031|182959766|SUPERIORITY|||||||0.8159|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.8159
91540603|NCT00304031|182959766|SUPERIORITY|||||||0.2174|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.2174
91763739|NCT01957202|183418095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.842|||<|0.0001|TWO_SIDED|95.0|-2.654|-1.029|||Mixed Model ANOVA|||||-1.029|-2.654|<0.0001
91763740|NCT01957202|183418095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.097|||<|0.0001|TWO_SIDED|95.0|-4.857|-3.337|||Mixed Model ANOVA|||||-3.337|-4.857|<0.0001
91763741|NCT01957202|183418095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.3699|TWO_SIDED|95.0|-0.994|0.372|||Mixed Model ANOVA|||||0.372|-0.994|0.3699
91540604|NCT00304031|182959767|OTHER|||||||0.023|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.||||0.023
91540605|NCT00304031|182959767|OTHER|||||||0.043|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.||||0.043
91540606|NCT00304031|182959767|OTHER|||||||0.021|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.||||0.021
91540607|NCT00304031|182959768|SUPERIORITY|||||||0.2357|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2357
91540608|NCT00304031|182959768|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.0147
91763742|NCT01957202|183418096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.364|||<|0.0001|TWO_SIDED|95.0|-1.853|-0.874|||Mixed Model ANOVA|||||-0.874|-1.853|<0.0001
91540609|NCT00304031|182959768|SUPERIORITY|||||||0.457|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.||||0.457
91540610|NCT00304031|182959769|SUPERIORITY|||||||0.02|||||||Chi-squared|Two-sided test||||||0.02
91540611|NCT00304031|182959770|SUPERIORITY|||||||0.99|||||||Fisher Exact|Two-sided test||||||0.99
91540612|NCT00304031|182959771|SUPERIORITY|||||||0.33|||||||Fisher Exact|Two-sided test||||||0.33
91540613|NCT00566735|182959787|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|Degrees of freedom = 28||Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).||||<0.05
91540614|NCT04603924|182959791|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement will be assumed to be \> 2 (i.e., no hospital discharge). Median time-to-clinical improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
91540615|NCT04603924|182959792|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement were be assumed to be \> 2 (i.e., no hospital discharge). Median number of days to a 2-point improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves.~In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
91540616|NCT03762668|182959798|NON_INFERIORITY|Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.005|||ONE_SIDED|95.0||0.01|||mixed effects repeated measures model||test minus control|||0.01||
91540617|NCT02164240|182959800|OTHER||Clinical Benefit Rate|0.0|||||TWO_SIDED|95.0|0.0|24.7||descriptive statistics only||||Clinical benefit rate of at least 30% at 16 weeks for the entire, combined population, was considered worthy of further study.||24.7|0|
91540618|NCT02544152|182959818|OTHER||||||=|0.987|||||||Cochran-Mantel-Haenszel|||P-value is from a Cochran-Mantel-Haenszel (CMH) test stratified by sex and baseline stool consistency||||=0.9870
91540619|NCT00465816|182959829|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenA GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.22|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.22|0.8|
91540620|NCT00465816|182959829|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenC GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.21|0.68|
91540621|NCT00465816|182959829|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenW-135 GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.02|||||TWO_SIDED|95.0|0.87|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.87|
91763743|NCT01957202|183418096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.1975|TWO_SIDED|95.0|-0.169|0.809|||Mixed Model ANOVA|||||0.809|-0.169|0.1975
91763744|NCT01957202|183418096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.252|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.635|||Mixed Model ANOVA|||||-0.635|-1.870|<0.0001
91763745|NCT01957202|183418096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432||||0.1648|TWO_SIDED|95.0|-0.179|1.042|||Mixed Model ANOVA|||||1.042|-0.179|0.1648
91763746|NCT01957202|183418096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.932||||0.0016|TWO_SIDED|95.0|-1.506|-0.358|||Mixed Model ANOVA|||||-0.358|-1.506|0.0016
91540622|NCT00465816|182959829|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenY GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.01|||||TWO_SIDED|95.0|0.85|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.85|
91540623|NCT00465816|182959830|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-1.19|3.9||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.||3.9|-1.19|
91540624|NCT00465816|182959831|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|-0.91|||||TWO_SIDED|95.0|-2.64|2.92||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.||2.92|-2.64|
91540625|NCT00818454|182959854|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
91540626|NCT00818454|182959855|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
91540627|NCT00818454|182959856|SUPERIORITY_OR_OTHER|||||||0.159|||||||MMRM ANCOVA|||||||0.159
91763747|NCT01957202|183418096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|||<|0.0001|TWO_SIDED|95.0|1.16|2.208|||Mixed Model ANOVA|||||2.208|1.160|<0.0001
91540628|NCT00818454|182959857|SUPERIORITY_OR_OTHER|||||||0.8278|||||||MMRM ANCOVA|||||||0.8278
91540629|NCT00818454|182959858|SUPERIORITY_OR_OTHER|||||||0.5098|||||||MMRM ANCOVA|||||||0.5098
91540630|NCT00818454|182959859|SUPERIORITY_OR_OTHER|||||||0.6591|||||||MMRM ANCOVA|||||||0.6591
91540631|NCT00818454|182959860|SUPERIORITY_OR_OTHER|||||||0.3631|||||||MMRM ANCOVA|||||||0.3631
91540632|NCT00818454|182959861|NON_INFERIORITY_OR_EQUIVALENCE|Enter additional comments here, if non-inferiority or equivalence analysis||||||0.6787|||||||MMRM ANCOVA|||||||0.6787
91540633|NCT00818454|182959862|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0001
91540634|NCT00818454|182959863|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0003
91540635|NCT00779870|182959868|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91540636|NCT00779870|182959868|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91540637|NCT03593213|182959886|SUPERIORITY||Hazard Ratio (HR)|0.56|||=|0.1576|TWO_SIDED|95.0|0.25|1.29||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.29|0.25|=0.1576
91540638|NCT03593213|182959886|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.2066|TWO_SIDED|95.0|0.26|1.45||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.45|0.26|=0.2066
91763748|NCT01957202|183418097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.3052|TWO_SIDED|95.0|-0.508|0.16|||Mixed Model ANOVA|||||0.160|-0.508|0.3052
91540639|NCT01152190|182959914|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.121||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.121
91540640|NCT01152190|182959915|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.226||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.226
91540641|NCT01152190|182959916|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.208||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.208
91540642|NCT01152190|182959916|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.066||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.066
91540643|NCT01152190|182959916|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.195||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.195
91540644|NCT01152190|182959916|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.022||0.625||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.625
91540645|NCT01152190|182959917|SUPERIORITY_OR_OTHER||Difference in LS Means|2.63|STANDARD_ERROR_OF_MEAN|3.38||0.439||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.439
91763749|NCT01957202|183418097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.2725|TWO_SIDED|95.0|-0.149|0.523|||Mixed Model ANOVA|||||0.523|-0.149|0.2725
91763750|NCT01957202|183418097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.536||||0.0118|TWO_SIDED|95.0|-0.952|-0.12|||Mixed Model ANOVA|||||-0.120|-0.952|0.0118
91763751|NCT01957202|183418097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175||||0.4049|TWO_SIDED|95.0|-0.588|0.239|||Mixed Model ANOVA|||||0.239|-0.588|0.4049
91763752|NCT01957202|183418097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.349||||0.0793|TWO_SIDED|95.0|-0.739|0.041|||Mixed Model ANOVA|||||0.041|-0.739|0.0793
91763753|NCT01957202|183418097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.361||||0.0478|TWO_SIDED|95.0|0.004|0.719|||Mixed Model ANOVA|||||0.719|0.004|0.0478
91763754|NCT01957202|183418098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.1502|TWO_SIDED|95.0|-0.509|0.079|||Mixed Model ANOVA|||||0.079|-0.509|0.1502
91763755|NCT01957202|183418098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075||||0.6177|TWO_SIDED|95.0|-0.37|0.221|||Mixed Model ANOVA|||||0.221|-0.370|0.6177
91763756|NCT01957202|183418098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.701||||0.0004|TWO_SIDED|95.0|-1.08|-0.322|||Mixed Model ANOVA|||||-0.322|-1.080|0.0004
91763757|NCT01957202|183418098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0035|TWO_SIDED|95.0|-0.934|-0.187|||Mixed Model ANOVA|||||-0.187|-0.934|0.0035
91763758|NCT01957202|183418098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.775|||<|0.0001|TWO_SIDED|95.0|-1.123|-0.428|||Mixed Model ANOVA|||||-0.428|-1.123|<0.0001
91763759|NCT01957202|183418098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.3807|TWO_SIDED|95.0|-0.175|0.456|||Mixed Model ANOVA|||||0.456|-0.175|0.3807
91763760|NCT00080301|183418125|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0003||95.17|0.64|0.88||Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)|Log Rank|95.17% confidence interval is adjusted for the interim analysis.||Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O'Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.||0.88|0.64|.0003
91763761|NCT00080301|183418126|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15|||<|0.0001||95.0|2.2|4.5|||Cochran-Mantel-Haenszel|||The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.||4.50|2.20|<.0001
91763762|NCT00080301|183418129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1936||95.17|0.77|1.05||Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).|Log Rank|Test was conducted at the α=0.05 level and no adjustments were performed.|Confidence Interval adjusted for interim analysis.|Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.||1.05|0.77|0.1936
91763763|NCT00080301|183418131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||.0002
91763764|NCT00991939|183418132|SUPERIORITY_OR_OTHER||Difference of proportions|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-0.975|0.708|||Fisher Exact||The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.|Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.||0.708|-0.975|1.00
91763765|NCT01965704|183418146|OTHER|||||||0.2|||||||Fisher Exact|||||||0.2
91763766|NCT01965704|183418147|OTHER||Mean Difference (Final Values)|-1.9||||0.56|TWO_SIDED|95.0|-8.0|4.3|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in overall length of stay.||4.3|-8.0|0.56
91763767|NCT01965704|183418147|OTHER||Median Difference (Final Values)|-1.9||||0.07|TWO_SIDED|95.0|-4.0|0.2|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in length of stay as calculated with maximum length capped at 15 days.||0.2|-4.0|0.07
91763768|NCT01965704|183418148|OTHER||Mean Difference (Final Values)|-1.8||||0.31|TWO_SIDED|95.0|-8.8|2.7|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|||2.7|-8.8|0.31
91763769|NCT02524171|183418152|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.1|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763770|NCT02524171|183418152|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.88|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91763771|NCT02524171|183418153|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763772|NCT02524171|183418153|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91540646|NCT01152190|182959917|SUPERIORITY_OR_OTHER||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|2.867||0.86||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.860
91540647|NCT01152190|182959917|SUPERIORITY_OR_OTHER||Difference in LS Means|3.47|STANDARD_ERROR_OF_MEAN|2.937||0.24||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.240
91540648|NCT01152190|182959917|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|2.729||0.839||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.839
91540649|NCT01152190|182959917|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|5.77||0.468||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.468
91540650|NCT01152190|182959917|SUPERIORITY_OR_OTHER||Difference in LS Means|7.93|STANDARD_ERROR_OF_MEAN|5.199||0.131||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.131
91540651|NCT00026312|182959940|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6803||||0.1016|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.1016
91540652|NCT00026312|182959941|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6176||||0.1057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.1057
91540653|NCT00026312|182959944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.0262|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The number of courses of therapy delivered or patients randomized to Regimen B - RA + Immunotherapy and non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease, were compared using the Wilcoxon rank-sum test.||||0.0262
91540654|NCT00026312|182959945|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|3.4471||||0.0634|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.0634
91540655|NCT00026312|182959945|SUPERIORITY_OR_OTHER_LEGACY||Log-Rank Test Statistic|4.1362||||0.042|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.042
91540656|NCT05850520|182959963|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin.|Difference in LS means|-0.1|||<|0.0001|TWO_SIDED|95.0|-2.0|1.9||1-sided p-value.|Mixed Models Analysis|Baseline BCVA measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.|8q8/3 -2q4||1.9|-2.0|<0.0001
91540657|NCT05850520|182959963|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin.|Difference in LS means|0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|2.7||1-sided p-value.|Mixed Models Analysis|Baseline BCVA measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.|8q8/5 -2q4||2.7|-1.1|<0.0001
91540658|NCT05850520|182959964|SUPERIORITY|Two-sided test (alpha = 0.05)|Difference in LS means|-2.7|||<|0.0001|TWO_SIDED|95.0|-2.8|-2.6||Nominal p-value based on a non-parametric rank ANCOVA adjusted for baseline BCVA, baseline CST, and the stratification variables.|ANCOVA|Adjusted for baseline BCVA, baseline CST, and the stratification variables.|Estimation based on composite strategy for premature treatment discontinuation due to treatment related AEs and hypothetical strategy for premature treatment discontinuation due to other reasons. Hypothetical values imputed using a MI model.|8q8/3 -2q4||-2.6|-2.8|<0.0001
91540659|NCT05850520|182959964|SUPERIORITY|Two-sided test (alpha = 0.05)|Difference in LS means|-1.8|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.7||Nominal p-value based on a non-parametric rank ANCOVA adjusted for baseline BCVA, baseline CST, and the stratification variables.|ANCOVA|Adjusted for baseline BCVA, baseline CST, and the stratification variables.|Estimation based on composite strategy for premature treatment discontinuation due to treatment related AEs and hypothetical strategy for premature treatment discontinuation due to other reasons. Hypothetical values imputed using a MI model.|8q8/5 -2q4||-1.7|-1.9|<0.0001
91540660|NCT05850520|182959968|SUPERIORITY|Two-sided test (alpha = 0.05)|Difference in LS means|-0.1||||0.9804|TWO_SIDED|95.0|-10.0|9.8||Nominal p-value for the two-sided test.|Mixed Models Analysis|Baseline CST measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.|Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.|8q8/3 - 2q4||9.8|-10.0|0.9804
91763773|NCT02524171|183418154|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|10.98|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763774|NCT02524171|183418154|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|14.64|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91540661|NCT05850520|182959968|SUPERIORITY|Two-sided test (alpha = 0.05)|Difference in LS means|1.2||||0.7863|TWO_SIDED|95.0|-7.7|10.2||Nominal p-value for the two-sided test.|Mixed Models Analysis|Baseline CST measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.|Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.|8q8/5 - 2q4||10.2|-7.7|0.7863
91540662|NCT05850520|182959969|SUPERIORITY|Two-sided test (alpha = 0.05)|Difference in LS means|-0.36||||0.6869|TWO_SIDED|95.0|-2.1|1.4||Nominal p-value for the two-sided test.|ANCOVA|Baseline NEI-VFQ-25 total score measurement used as a covariate and treatment group, visit, and stratification variables as fixed factors.|Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing active injection) were censored. Missing/censored data was imputed by LOCF approach.|8q8/3 - 2q4||1.40|-2.1|0.6869
91540663|NCT05850520|182959969|SUPERIORITY||Difference in LS means|0.65|||||TWO_SIDED|95.0|-1.2|2.45|||ANCOVA|Baseline NEI-VFQ-25 total score measurement used as a covariate and treatment group, visit, and stratification variables as fixed factors.|Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing active injection) were censored. Missing/censored data was imputed by LOCF approach.|8q8/5 - 2q4||2.45|-1.2|
91540664|NCT03785782|182959995|OTHER|||||||0.2988|||||||Regression, Logistic|||||||0.2988
91540665|NCT03785782|182959996|OTHER|||||||0.36|||||||Regression, Linear|||||||0.36
91540666|NCT03785782|182959997|OTHER|||||||0.43|||||||Regression, Linear|||||||0.43
91763775|NCT02524171|183418155|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.45|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews||||||>0.05
91540667|NCT03785782|182959998|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
91540668|NCT03785782|182959999|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
91540669|NCT03785782|182960000|OTHER|||||||0.18|||||||Regression, Linear|||||||0.18
91540670|NCT03785782|182960001|OTHER|||||||0.78|||||||Regression, Linear|||||||0.78
91540671|NCT03785782|182960002|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
91540672|NCT03785782|182960003|OTHER|||||||0.34|||||||Regression, Linear|||||||0.34
91540673|NCT03785782|182960004|OTHER|||||||0.7465|||||||Regression, Logistic|||||||0.7465
91540674|NCT03785782|182960005|OTHER|||||||0.0466|||||||Regression, Logistic|||||||0.0466
91540675|NCT03785782|182960006|OTHER|||||||0.1567|||||||Regression, Logistic|||||||0.1567
91540676|NCT03785782|182960007|OTHER|||||||0.1837|||||||Regression, Logistic|||||||0.1837
91540677|NCT03785782|182960008|OTHER|||||||0.7447|||||||Regression, Logistic|||||||0.7447
91540678|NCT03785782|182960009|OTHER|||||||0.0739|||||||Regression, Logistic|||||||0.0739
91540679|NCT03785782|182960010|OTHER|||||||0.9995|||||||Regression, Logistic|||||||0.9995
91540680|NCT02396316|182960030|SUPERIORITY_OR_OTHER||Difference of LS mean change|-4.9||||0.0644|TWO_SIDED|95.0|-10.2|0.3|||ANCOVA|||Point estimate, 95% CI and P-value were based on treatment difference of the LS mean changes using an ANCOVA model with treatment group and stage of NVG for randomization as fixed effects, baseline value as covariate. The superiority of aflibercept injection to sham injection was to be established if the upper limit of the two-sided 95% confidence interval for the difference (the aflibercept group minus the sham group) is less than 0.||0.3|-10.2|0.0644
91540681|NCT02396316|182960031|SUPERIORITY_OR_OTHER||MH adjusted difference|59.1|||||TWO_SIDED|95.0|37.0|81.2|||Mantel Haenszel|||The point estimate of the treatment difference (the aflibercept group minus the sham group) at Week 1 and its two-sided 95% confidence interval stratified by stage of NVG (as randomized) using Mantel-Haenszel weights.||81.2|37.0|
91540682|NCT02731755|182960035|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||Between time points and treatments, calculated p value||||0.5
91540683|NCT02731755|182960036|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Ach-iAUC||||0.04
91540684|NCT02731755|182960036|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||SNP-IAUC||||0.007
91540685|NCT02731755|182960036|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Ach - AUC||||0.02
91540686|NCT02731755|182960037|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
91540687|NCT02731755|182960039|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.7
91540688|NCT02139046|182960056|SUPERIORITY_OR_OTHER||Difference in Proportions|25.6|||<|0.001|TWO_SIDED|95.0|20.4|30.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the Cui, Hung, and Wang (CHW) Z-test which accounts for the interim analysis.||||30.9|20.4|<0.001
91540689|NCT02139046|182960056|SUPERIORITY_OR_OTHER||Difference in Proportions|49.8|||<|0.001|TWO_SIDED|95.0|43.9|55.8||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||55.8|43.9|<0.001
91540690|NCT02139046|182960056|SUPERIORITY_OR_OTHER||Difference in Proportions|10.2||||0.001|TWO_SIDED|95.0|3.5|17.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||17.0|3.5|0.001
91763776|NCT02524171|183418155|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.22|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91540691|NCT02139046|182960056|SUPERIORITY_OR_OTHER||Difference in Proportions|7.5||||0.043|TWO_SIDED|95.0|-0.8|15.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||15.9|-0.8|0.043
91540692|NCT02139046|182960057|SUPERIORITY_OR_OTHER||Difference in Proportions|2.1||||0.503|TWO_SIDED|95.0|-4.9|9.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||9.0|-4.9|0.503
91540693|NCT02139046|182960057|SUPERIORITY_OR_OTHER||Difference in Proportions|5.9||||0.064|TWO_SIDED|95.0|-1.2|13.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||13.0|-1.2|0.064
91540694|NCT02139046|182960057|SUPERIORITY_OR_OTHER||Difference in Proportions|1.8||||0.561|TWO_SIDED|95.0|-5.1|8.7||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||8.7|-5.1|0.561
91540695|NCT02139046|182960057|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.5||||0.869|TWO_SIDED|95.0|-8.0|6.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||6.9|-8.0|0.869
91540696|NCT02139046|182960058|SUPERIORITY_OR_OTHER||Difference in Proportions|47.6|||<|0.001|TWO_SIDED|95.0|41.6|53.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||53.6|41.6|<0.001
91763777|NCT02524171|183418156|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763778|NCT02524171|183418156|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
91540697|NCT02139046|182960058|SUPERIORITY_OR_OTHER||Difference in Proportions|60.5|||<|0.001|TWO_SIDED|95.0|54.6|66.3||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||66.3|54.6|<0.001
91763779|NCT02524171|183418157|SUPERIORITY||Time x Condition at 6mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91540698|NCT02139046|182960058|SUPERIORITY_OR_OTHER||Difference in Proportions|7.8||||0.036|TWO_SIDED|95.0|-0.5|16.1||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||16.1|-0.5|0.036
91540699|NCT02139046|182960058|SUPERIORITY_OR_OTHER||Difference in Proportions|3.3||||0.364|TWO_SIDED|95.0|-4.9|11.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||11.6|-4.9|0.364
91540700|NCT00773370|182960066|SUPERIORITY_OR_OTHER||difference between slopes|8.43|STANDARD_DEVIATION|7.17|<|0.25|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||<0.25
91540701|NCT00773370|182960066|SUPERIORITY_OR_OTHER||Slope|14.95|STANDARD_DEVIATION|4.92|<|0.004|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||<0.004
91540702|NCT00773370|182960066|SUPERIORITY_OR_OTHER||Slope|6.52|STANDARD_DEVIATION|5.13||0.218|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.218
91540703|NCT00773370|182960067|SUPERIORITY_OR_OTHER||Difference between slopes|0.186|STANDARD_DEVIATION|0.256||0.47|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.47
91540704|NCT00773370|182960067|SUPERIORITY_OR_OTHER||Slope|0.215|STANDARD_DEVIATION|0.175||0.225|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.225
91540705|NCT00773370|182960067|SUPERIORITY_OR_OTHER||Slope|0.029|STANDARD_DEVIATION|0.187||0.88|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.88
91540706|NCT00773370|182960068|SUPERIORITY_OR_OTHER||Difference between slopes|0.002|STANDARD_DEVIATION|0.078||0.98|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.98
91540707|NCT00773370|182960068|SUPERIORITY_OR_OTHER||Slope|0.033|STANDARD_DEVIATION|0.054||0.54|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.54
91540708|NCT00773370|182960068|SUPERIORITY_OR_OTHER||Slope|0.031|STANDARD_DEVIATION|0.057||0.59|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.59
91540709|NCT00773370|182960069|SUPERIORITY_OR_OTHER||Slope|0.296|STANDARD_DEVIATION|9.77||0.98|TWO_SIDED||||||ANOVA|||Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.||||.98
91540710|NCT00773370|182960069|SUPERIORITY_OR_OTHER||Slope|15.49|STANDARD_DEVIATION|6.19||0.02|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.02
91540711|NCT00773370|182960069|SUPERIORITY_OR_OTHER||Slope|15.193|STANDARD_DEVIATION|7.553||0.051|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.051
91540712|NCT01765543|182960070|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.614|||||TWO_SIDED|90.0|0.484|0.78||||||Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.780|0.484|
91540713|NCT01765543|182960071|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.596|||||TWO_SIDED|90.0|0.469|0.759||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.759|0.469|
91763780|NCT02524171|183418157|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91763781|NCT02524171|183418158|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91540714|NCT01765543|182960072|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.908|1.36||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||1.36|0.908|
91540715|NCT01185561|182960078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.89|STANDARD_ERROR_OF_MEAN|2.43||0.001|TWO_SIDED|95.0|4.03|13.76|||t-test, 2 sided|||The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||13.76|4.03|.001
91540716|NCT01185561|182960079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|STANDARD_ERROR_OF_MEAN|3.27||0.02|TWO_SIDED|95.0|1.29|14.37|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.37|1.29|.02
91540717|NCT01185561|182960080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|2.91||0.005|TWO_SIDED|95.0|2.64|14.31|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.31|2.64|.005
91540718|NCT01185561|182960081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|3.75||0.85|TWO_SIDED|95.0|-6.77|8.24|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||8.24|-6.77|.85
91540719|NCT02755805|182960089|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.11||||0.007|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|"F(3,74)=4.37~P-values were calculated using mixed model analyses and controlled for stoke severity as a covariate."|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.007
91540720|NCT02755805|182960090|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.76||||0.09|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=2.55|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.09
91540721|NCT02755805|182960091|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.23||||0.002|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=7.83|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.||||.002
91540722|NCT02755805|182960092|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.7||||0.04|TWO_SIDED|||||a priori threshold set at \<0.05|repeated measures fixed effects model|F(2,28)=3.61|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||.04
91540723|NCT03718767|182960109|OTHER||Hazard Ratio (HR)|1.0||||0.623|TWO_SIDED||||||Regression, Cox|||||||0.623
91540724|NCT03718767|182960109|OTHER||Hazard Ratio (HR)|1.73||||0.073|TWO_SIDED||||||Regression, Cox|||||||0.073
91540725|NCT02658240|182960121|SUPERIORITY|||||||0.05|||||||ANOVA|||The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.||||0.05
91540726|NCT02658240|182960122|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
91540727|NCT02658240|182960123|SUPERIORITY|||||||0.149|TWO_SIDED|80.0|||||t-test, 2 sided|||||||0.149
91540728|NCT02658240|182960124|SUPERIORITY|||||||0.584|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.584
91540729|NCT03691428|182960125|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91540730|NCT03691428|182960126|SUPERIORITY|A multivariate dyadic linear growth curve model was used to predict the trajectories of psychological well-being (Raudenbush, Brennan, \& Barnett, 1995).|||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91540731|NCT03691428|182960127|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91540732|NCT03691428|182960128|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91540733|NCT03691428|182960129|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
91540734|NCT04589689|182960182|OTHER|||||||0.777||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3 months.||||0.777
91540735|NCT04589689|182960182|OTHER|||||||0.247||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month.||||0.247
91540736|NCT04589689|182960183|OTHER|||||||0.16||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.160
91540737|NCT04589689|182960183|OTHER|||||||0.275||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.275
91540738|NCT04589689|182960184|OTHER|||||||0.509||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.509
91540739|NCT04589689|182960184|OTHER|||||||0.61||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.610
91540740|NCT04589689|182960185|OTHER|||||||0.807||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.807
91540741|NCT04589689|182960185|OTHER|||||||0.826||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.826
91540742|NCT04589689|182960186|OTHER|||||||0.076||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.076
91540743|NCT04589689|182960186|OTHER|||||||0.747||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.747
91540744|NCT04589689|182960187|OTHER|||||||0.154||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.154
91540745|NCT04589689|182960187|OTHER|||||||0.107||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.107
91540746|NCT04589689|182960188|OTHER|||||||0.445||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.445
91540747|NCT04589689|182960188|OTHER|||||||0.543||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.543
91540748|NCT04589689|182960189|OTHER|||||||0.157||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.157
91540749|NCT01254019|182960208|SUPERIORITY||Mean Difference (Net)|10.334||||0.415|TWO_SIDED|95.0|-14.645|35.312||Statistical significance was assessed at the 5% level.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||35.312|-14.645|0.415
91540750|NCT01254019|182960209|SUPERIORITY||Mean Difference (Net)|-0.53||||0.757|TWO_SIDED|95.0|-3.95|2.88||Statistical significance (SS) was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||2.88|-3.95|0.757
91763782|NCT02524171|183418158|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||<0.05
91763783|NCT02524171|183418159|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
91763784|NCT02524171|183418159|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91763785|NCT02524171|183418160|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta|0.69|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763786|NCT02524171|183418160|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|-0.89|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91540751|NCT01254019|182960210|SUPERIORITY||Mean Difference (Net)|-0.021||||0.718|TWO_SIDED|95.0|-0.137|0.095||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.095|-0.137|0.718
91540752|NCT01254019|182960211|SUPERIORITY||Mean Difference (Net)|-0.009||||0.881|TWO_SIDED|95.0|-0.129|0.111||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.111|-0.129|0.881
91540753|NCT01254019|182960212|SUPERIORITY||Mean Difference (Net)|-1.115||||0.658|TWO_SIDED|95.0|-6.097|3.866||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||3.866|-6.097|0.658
91540754|NCT01254019|182960213|SUPERIORITY||Mean Difference (Net)|0.041||||0.513|TWO_SIDED|95.0|-0.082|0.164||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.164|-0.082|0.513
91763787|NCT02524171|183418161|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.07|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763788|NCT02524171|183418161|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
91540755|NCT01254019|182960214|SUPERIORITY||Mean Difference (Net)|-0.965||||0.769|TWO_SIDED|95.0|-7.446|5.516||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||5.516|-7.446|0.769
91540756|NCT01254019|182960217|SUPERIORITY||Mean Difference (Net)|-4044.99||||0|TWO_SIDED|95.0|-5232.21|-2857.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||-2857.77|-5232.21|0.000
91540757|NCT01254019|182960223|SUPERIORITY||Mean Difference (Net)|0.0288||||0.207|TWO_SIDED|95.0|-0.0161|0.0738||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI2 at Week 48||0.0738|-0.0161|0.207
91540758|NCT01254019|182960223|SUPERIORITY||Mean Difference (Net)|0.0048||||0.88|TWO_SIDED|95.0|-0.058|0.0676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI3 at Week 48||0.0676|-0.0580|0.880
91540759|NCT03061474|182960232|SUPERIORITY|||||||0.6096|||||||ANCOVA|||||||0.6096
91540760|NCT03061474|182960242|SUPERIORITY|||||||0.648|||||||ANCOVA|||||||0.648
91540761|NCT03061474|182960243|SUPERIORITY|||||||0.6833|||||||ANCOVA|||||||0.6833
91540762|NCT03061474|182960244|SUPERIORITY|||||||0.4438|||||||ANCOVA|||||||0.4438
91540763|NCT03061474|182960245|SUPERIORITY|||||||0.7158|||||||ANCOVA|||||||0.7158
91540764|NCT03061474|182960246|SUPERIORITY|||||||0.93428359|||||||ANCOVA|||||||0.93428359
91540765|NCT03061474|182960247|SUPERIORITY|||||||0.9931|||||||ANCOVA|||||||0.9931
91540766|NCT03061474|182960248|SUPERIORITY|||||||0.3233|||||||Mixed Models Analysis|||||||0.3233
91540767|NCT03061474|182960249|SUPERIORITY|||||||0.1008|||||||Mixed Models Analysis|||||||0.1008
91540768|NCT03061474|182960250|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
91540769|NCT01391130|182960270|SUPERIORITY||Hazard Ratio (HR)|1.2149||||0.4318|TWO_SIDED|95.0|0.7462|1.9779|||Log Rank|||||1.9779|0.7462|0.4318
91540770|NCT03520413|182960279|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.12|-0.11|||Mixed Models Analysis|||||-0.11|-1.12|0.02
91540771|NCT03520413|182960280|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.25||||0.007|TWO_SIDED|95.0|-0.42|-0.07|||Mixed Models Analysis|||||-0.07|-0.42|0.007
91540772|NCT03520413|182960281|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.51||||0.0002|TWO_SIDED|95.0|0.25|0.78|||Mixed Models Analysis|||||0.78|0.25|0.0002
91540773|NCT03520413|182960282|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.39||||0.02|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.02
91540774|NCT03520413|182960283|EQUIVALENCE|Difference between groups at 6months|Mean Difference (Final Values)|0.19||||0.39|TWO_SIDED|95.0|-0.24|0.62|||Mixed Models Analysis|||||0.62|-0.24|0.39
91540775|NCT03520413|182960284|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-1.16||||0.1|TWO_SIDED|95.0|-2.53|0.21|||Mixed Models Analysis|||||0.21|-2.53|0.10
91540776|NCT00566527|182960304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 2 - Arm 3)|-0.91|||||TWO_SIDED|95.0|-2.82|0.87||||||Measles difference||0.87|-2.82|
91540777|NCT00566527|182960304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 2 - Arm 3)|0.03|||||TWO_SIDED|95.0|-1.2|1.32||||||Mumps difference||1.32|-1.20|
91540778|NCT00566527|182960304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 2 - Arm 3)|-0.22|||||TWO_SIDED|95.0|-1.55|1.03||||||Rubella difference||1.03|-1.55|
91540779|NCT00566527|182960304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 2 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.28|1.1||||||Varicella difference||1.10|-1.28|
91540780|NCT00566527|182960305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 1 - Arm 3)|-3.97|||||TWO_SIDED|95.0|-6.44|-1.87||||||Measles difference||-1.87|-6.44|
91540781|NCT00566527|182960305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 1 - Arm 3)|-0.35|||||TWO_SIDED|95.0|-1.71|1.01||||||Mumps difference||1.01|-1.71|
91540782|NCT00566527|182960305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 1 - Arm 3)|-0.15|||||TWO_SIDED|95.0|-1.34|1.09||||||Rubella difference||1.09|-1.34|
91763789|NCT02524171|183418162|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|6.53|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763790|NCT02524171|183418162|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|5.68|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63||||>0.05
91763791|NCT02524171|183418163|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.83|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91540783|NCT00566527|182960305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 1 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.83|1.1||||||Varicella difference||1.10|-1.83|
91540784|NCT03654768|182960336|SUPERIORITY|||||||0.09|||||||Fisher Exact|||||||0.09
91540785|NCT03654768|182960337|SUPERIORITY|||||||0.3|||||||Log Rank|||||||0.30
91540786|NCT03654768|182960338|SUPERIORITY|||||||0.9|||||||Log Rank|||||||0.90
91540787|NCT02601170|182960424|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91540788|NCT00732381|182960445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||ANCOVA|||||||0.006
91540789|NCT00732381|182960446|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<.001
91540790|NCT02582593|182960455|SUPERIORITY||Cohen's D|0.27||||0.575|TWO_SIDED|||||t = .581, only 1 comparison (2 groups) and thus multiple comparison correction not needed|t-test, 2 sided|||An independent sample t-test was used to examine difference in Pre-post intervention change scores for the Active and Sham groups;. Cohen's d was calculated to determine effect size.||||.575
91540791|NCT02582593|182960456|SUPERIORITY||Cohen's D|1.06||||0.16|TWO_SIDED|||||t = 1.574; only two comparisons, thus not necessary to adjust|t-test, 2 sided|||independent t-test, cohen's d effect size||||.160
91540792|NCT02582593|182960457|SUPERIORITY||Cohen's D|0.27||||0.424|TWO_SIDED||||||t-test, 2 sided|||independent t-test, Cohen's d effect size||||.424
91540793|NCT02582593|182960458|SUPERIORITY||Cohen's D|-1.03||||0.099|TWO_SIDED|||||no adjustment necessary, only 1 comparison|t-test, 2 sided|||independent sample t-test, Cohen's d effect size||||0.099
91540794|NCT00463788|182960468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.126||||0.1109|TWO_SIDED|95.0|0.809|5.591|||Cochran-Mantel-Haenszel|Randomization strata: first- or second line according to Interactive Voice Response System (IVRS).||||5.591|0.809|0.1109
91540795|NCT00463788|182960469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.675||||0.0324|TWO_SIDED|95.0|0.47|0.969|||Log Rank|||||0.969|0.470|0.0324
91540796|NCT00463788|182960470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.3121|TWO_SIDED|95.0|0.561|1.204|||Log Rank|||||1.204|0.561|0.3121
91540797|NCT00463788|182960471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.5993|TWO_SIDED|95.0|0.262|2.17|||Log Rank|||||2.170|0.262|0.5993
91540798|NCT00360698|182960473|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.68||||0.0499||95.0|0.01|28.37|||Chi-squared||Difference in percentage between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the percentage of patients with Glycosylated Haemoglobin (HbA1c) level \<7%. A sample size of 98 randomized (49/arm) patients would allow to demonstrate with 80% power that 40 % of patients in the Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group would achieve a HbA1c level \< 7 % compared to 15 % of patients in the Insulin Glargine+Metformin+Glimepiride group(5% alpha risk, 2-sided test).||28.37|0.01|0.0499
91540799|NCT00360698|182960475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.116||0.029||95.0|-0.49|-0.03||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline HbA1c as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no difference between the 2 treatment groups regarding the adjusted mean change from baseline in Glycosylated Haemoglobin (HbA1c) at the end of treatment.||-0.03|-0.49|0.029
91540800|NCT00360698|182960477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|4.987||0.0109||95.0|-22.83|-3.04||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline daily mean plasma glucose as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in daily mean plasma glucose at the end of treatment.||-3.04|-22.83|0.0109
91540801|NCT00360698|182960478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.431||0.5762||95.0|-0.61|1.1||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline weight as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in weight at the end of treatment.||1.1|-0.61|0.5762
91540802|NCT00360698|182960481|SUPERIORITY_OR_OTHER|||||||0.958||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.958
91540803|NCT00360698|182960482|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of nocturnal symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.302
91540804|NCT00360698|182960483|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of severe symptomatic hypoglycemia during the treatment period.||||0.192
91540805|NCT02200770|182960484|SUPERIORITY||Hazard Ratio (HR)|0.272|||<|0.0001|TWO_SIDED|95.0|0.1496|0.4961|||Regression, Cox|||||0.4961|0.1496|<0.0001
91540806|NCT02200770|182960485|SUPERIORITY||Odds Ratio (OR)|0.352||||0.0033|TWO_SIDED|95.0|0.1755|0.7059|||Regression, Logistic|||||0.7059|0.1755|0.0033
91540807|NCT02200770|182960486|SUPERIORITY||Mean Difference (Net)|0.134|STANDARD_ERROR_OF_MEAN|1.096||0.9026|TWO_SIDED|95.0|-2.0254|2.2941|||ANCOVA|||||2.2941|-2.0254|0.9026
91540808|NCT02200770|182960487|SUPERIORITY||Rate Ratio|0.566||||0.0034|TWO_SIDED|95.0|0.3866|0.8279|||Negative Binomial Regression|||||0.8279|0.3866|0.0034
91540809|NCT02200770|182960488|SUPERIORITY||Rate Ratio|0.317||||0.0146|TWO_SIDED|95.0|0.1257|0.7972|||Negative Binomial Regression|||||0.7972|0.1257|0.0146
91540810|NCT03401112|182960524|SUPERIORITY|||||||0.0686|||||||Log Rank|||||||0.0686
91540811|NCT03401112|182960524|SUPERIORITY|||||||0.0294|||||||Log Rank|||||||0.0294
91540812|NCT03475316|182960528|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.14|1.49|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the composite score pre and post intervention.||1.49|-1.14|
91540813|NCT03475316|182960529|SUPERIORITY||Mean Difference (Net)|166.16|STANDARD_ERROR_OF_MEAN|-202.7|||TWO_SIDED|95.0|-231.12|563.44|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Digit Symbol Substitution test at post intervention from pre intervention between the social dancing and treadmill walking group.||563.44|-231.12|
91540814|NCT03475316|182960529|SUPERIORITY||Mean Difference (Net)|24.6|STANDARD_ERROR_OF_MEAN|28.47|||TWO_SIDED|95.0|-31.2|80.4|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) and p-values are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Flanker interference test at post intervention from pre intervention between the social dancing and treadmill walking group.||80.40|-31.20|
91540815|NCT03475316|182960529|SUPERIORITY||Mean Difference (Net)|58.22|STANDARD_ERROR_OF_MEAN|51.2|||TWO_SIDED|95.0|-42.14|158.58|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in functional activation/deactivation covariance patterns during the Imagery of Walking-While Talking task at post intervention from pre intervention between the social dancing and treadmill walking group.||158.58|-42.14|
91540816|NCT03475316|182960530|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.1|6.64|||||The Estimation Parameter is the difference in change at post from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the CHAMPS scores pre and post intervention.||6.64|-5.10|
91540817|NCT03475316|182960531|SUPERIORITY||Mean Difference (Final Values)|7.27|STANDARD_ERROR_OF_MEAN|8.57|||TWO_SIDED|95.0|-11.6|26.14|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in gait speed pre and post intervention.||26.14|-11.60|
91540818|NCT03475316|182960532|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-13.4|14.55|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in unipedal stance time pre and post intervention.||14.55|-13.40|
91540819|NCT03475316|182960534|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-1.3|3.46|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the geriatric depression scale pre and post intervention.||3.46|-1.30|
91540820|NCT02476409|182960535|SUPERIORITY|||||||0.094|||||||Kruskal-Wallis|||||||0.094
91763792|NCT02524171|183418163|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.46|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.01
91540821|NCT02476409|182960536|SUPERIORITY|||||||0.166|||||||Kruskal-Wallis|||||||0.166
91763793|NCT02524171|183418164|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763794|NCT02524171|183418164|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|-0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
91540822|NCT02476409|182960536|SUPERIORITY|||||||0.491|||||||Kruskal-Wallis|||||||0.491
91540823|NCT02476409|182960537|SUPERIORITY|||||||0.543|||||||Kruskal-Wallis|||P-value for Change in Dyspnea VAS - Baseline to Day 3 Tolvaptan versus placebo.||||0.543
91540824|NCT02476409|182960538|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.050
91540825|NCT02476409|182960539|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
91540826|NCT02476409|182960540|SUPERIORITY|||||||0.034|||||||Kruskal-Wallis|||||||0.034
91540827|NCT02476409|182960541|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||||||0.643
91540828|NCT00275392|182960542|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||0.026
91540829|NCT00275392|182960542|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||main effect of time|RM ANOVA|||||||<.001
91540830|NCT00275392|182960542|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||main effect of group|RM ANOVA|||||||>.05
91540831|NCT00275392|182960543|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||> 0.05
91540832|NCT00275392|182960543|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||main effect of time|RM ANOVA|||||||.016
91540833|NCT00275392|182960543|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Main effect of Group|RM ANOVA|||||||>.05
91540834|NCT00457743|182960583|SUPERIORITY_OR_OTHER||Disease control Rate (percentage)|56.7||||||95.0|37.4|74.5|||||The disease control rate, defined as the percentage of subjects confirmed with CR, PR, and SD \>=10 weeks on study according to RECIST.|||74.5|37.4|
91540835|NCT00457743|182960585|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|13.3||||||95.0|3.8|30.7|||||The subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|||30.7|3.8|
91540836|NCT00457743|182960594|SUPERIORITY_OR_OTHER||CBR rate (percentage)|40.0||||||95.0|22.7|59.4|||||The clinical benefit response (CBR) rate, defined as the percentage of the subjects confirmed with CR, PR, or SD\>=22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|||59.4|22.7|
91540837|NCT04975308|182960631|SUPERIORITY||Hazard Ratio (HR)|0.867||||0.1158|TWO_SIDED|95.0|0.724|1.039|||Log Rank|||||1.039|0.724|0.1158
91540838|NCT04975308|182960632|SUPERIORITY||Hazard Ratio (HR)|0.569|||<|0.0001|TWO_SIDED|95.0|0.441|0.733|||Log Rank|||||0.733|0.441|<0.0001
91540839|NCT04975308|182960633|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0008|TWO_SIDED|95.0|0.464|0.821|||Log Rank|||||0.821|0.464|0.0008
91540840|NCT00468910|182960652|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The study was powered to detect an attributable change in the aspirin group of 50% relative to baseline values - an approximate 50% increase in spectral slope.||||0.11
91540841|NCT00468910|182960653|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
91540842|NCT05323734|182960678|OTHER||Median Difference (Final Values)|-14.53||||0.0904|TWO_SIDED|95.0|-32.04|2.48|||Wilcoxon Rank-Sum|Wilcoxon Rank-Sum statistic is applied using a 2-sided significance level of 0.05.|The Hodges-Lehmann approach is applied for estimating 95% confidence interval.|||2.48|-32.04|0.0904
91540843|NCT05323734|182960679|OTHER||Difference in percentage|6.4||||0.3407|TWO_SIDED|95.0|-6.4|20.1|||Fisher Exact|||||20.1|-6.4|0.3407
91540844|NCT05323734|182960680|OTHER||Odds Ratio (OR)|0.88||||0.7069|TWO_SIDED|95.0|0.46|1.7|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.70|0.46|0.7069
91763795|NCT02524171|183418165|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.03|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763796|NCT02524171|183418165|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
91763797|NCT02524171|183418166|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
91763798|NCT02524171|183418166|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
91763799|NCT02524171|183418167|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
91763800|NCT02524171|183418167|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
91763801|NCT02868554|183418175|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.07|TWO_SIDED||||||ANOVA|||||||0.07
91763802|NCT02868554|183418176|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
91763803|NCT05282927|183418202|SUPERIORITY||Mean Difference (Net)|-0.05||||0.92|TWO_SIDED|95.0|-1.07|0.98|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans)||0.98|-1.07|0.92
91763804|NCT05282927|183418203|SUPERIORITY||Mean Difference (Net)|0.94||||0.056|TWO_SIDED|95.0|-0.03|1.9|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans).||1.90|-0.03|0.056
91763805|NCT01100320|183418219|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|99.9|||||TWO_SIDED|90.0|95.4|104.52|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.52|95.40|
91763806|NCT01100320|183418220|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.11|95.09|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.09|90.11|
91540845|NCT05323734|182960681|OTHER||Odds Ratio (OR)|0.85||||0.6434|TWO_SIDED|95.0|0.42|1.72|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.72|0.42|0.6434
91540846|NCT04345913|182960723|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.5259|||||||Log Rank|||||||0.5259
91540847|NCT04345913|182960728|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.706|||||||Log Rank|||||||0.7060
91540848|NCT00357097|182960779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||<|0.001||95.0|-5.6|-1.6|||ANCOVA||Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.|||-1.6|-5.6|<0.001
91540849|NCT00385801|182960815|SUPERIORITY_OR_OTHER|||||||0.86||||||The effect of treatment on intensity of craving was assessed and the threshold for statistical significance was p \< 0.05|Mixed Models Analysis|F=0.03||Intensity of craving||||0.86
91540850|NCT03505099|182960818|SUPERIORITY||Difference of Proportion|76.5|||<|0.0001|TWO_SIDED|95.0|50.95|92.21|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 19 out of 81 participants (23.46%) with 3 copies of SMN2 achieved standing alone for at least 3 seconds.|92.21|50.95|<0.0001
91540851|NCT03505099|182960819|SUPERIORITY||Difference of Proportion|73.9|||<|0.0001|TWO_SIDED|95.0|44.67|91.61|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 participants (26.09%) with 2 copies of SMN2 were alive and did not require permanent ventilation.|91.61|44.67|<0.0001
91540852|NCT03505099|182960821|SUPERIORITY||Difference of Proportion|72.3|||<|0.0001|TWO_SIDED|95.0|44.9|90.11|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 17 out of 81 participants (20.99%) with 3 copies of SMN2 achieved the ability to walk alone.|90.11|44.90|<0.0001
91540853|NCT03603717|182960822|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91540854|NCT03603717|182960823|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91540855|NCT03603717|182960824|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
91540856|NCT03603717|182960825|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91763807|NCT01100320|183418221|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.13|95.13|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.13|90.13|
91540857|NCT00457691|182960831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.095||||0.8072|TWO_SIDED|95.0|0.892|1.344||p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.344|0.892|0.8072
91540858|NCT00457691|182960832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.9163|TWO_SIDED|95.0|0.936|1.466||p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.466|0.936|0.9163
91540859|NCT00414544|182960870|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was tested.|Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.6|||TWO_SIDED|90.0|-2.0|1.0|||Confidence interval|The 90% lower confidence bound of the difference between CosmetaLife and Restylane were computed.|The confidence interval is built around the mean difference of the two reporting groups.|The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.||1.0|-2.0|
91540860|NCT04425863|182960893|OTHER|||||||0.0246|||||||Chi-squared|||A chi-squared test is used to find out whether there is a statistically significant decrease in mortality rate when the IDEA treatment protocol is used in hospitalized patients in comparison with other treatments in the same hospital in the same period of time (3 out of 12 inpatients died)||||0.0246
91540861|NCT04425863|182960893|OTHER|||||||0.0475|||||||Chi-squared|||Overall mortality rate of patients treated according to IDEA protocol is compared by a chi-squared test against overall mortality rate in Argentina (the same region where the hospital is located). Data used for overall mortality in Argentina correspond to June 30th according to the website of the Ministry of Health of Argentina||||0.0475
91540862|NCT04425863|182960893|OTHER|||||||0.0025|||||||Chi-squared|||A chi-square test was applied to compare the mortality rate of patients treated with IDEA protocol as compared with data published (26.84 %) in Bertsimas D, Lukin G, Mingardi L, Nohadani O, Orfanoudaki A, Stellato B et al. (2020), COVID-19 Mortality Risk Assessment: An International Multi-Center Study doi: 10.1101/2020.07.07.20148304||||0.0025
91540863|NCT02527148|182960914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the control cases||||<0.0001
91540864|NCT02527148|182960914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the Shapematch cases||||<0.0001
91540865|NCT02527148|182960914|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 weeks between both groups.||||0.0004
91540866|NCT02527148|182960914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 months for Control cases.||||<0.0001
91540867|NCT02527148|182960914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement form preoperative to 6 months for Shapematch cases.||||<0.0001
91540868|NCT02527148|182960914|SUPERIORITY|||||||0.3894|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 months between both groups.||||0.3894
91763808|NCT04181762|183418222|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.0662|TWO_SIDED|95.0|-26.3|0.9|||Regression, Logistic||Difference from placebo and 95% CI are from a logistic regression model with treatment group, stratification factor (SoC) and race as factors and baseline UPCR as a covariate using marginal standardization method.|Complete Renal Response (CRR) at Week 52||0.9|-26.3|0.0662
91763809|NCT04181762|183418224|OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-23.7|8.4|||||95% Confidence Intervals (CIs) are constructed using the exact binomial test.|Partial Renal Response (PRR) at Week 52||8.4|-23.7|
91540869|NCT02527148|182960914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Control cases||||<0.0001
91540870|NCT02527148|182960914|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Shapematch cases||||<0.0001
91540871|NCT02527148|182960914|SUPERIORITY|||||||0.4387|||||||t-test, 2 sided|p-values from repeated ANOVA with change from preoperative variable/scores as dependent variable.||To compare improvement of OKS from preoperative to 12 months between both groups.||||0.4387
91540872|NCT02527148|182960914|SUPERIORITY|||||||0.261|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 2 years between both groups.||||0.2610
91540873|NCT02527148|182960914|SUPERIORITY|||||||0.8458|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 5 years between both groups.||||0.8458
91540874|NCT02527148|182960915|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||To compare mean duration of surgery between both groups.||||0.10
91540875|NCT02527148|182960916|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||To compare wound length between both groups.||||0.05
91540876|NCT02527148|182960918|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||To compare average length of hospital stay between both groups.||||0.07
91540877|NCT02527148|182960919|SUPERIORITY||Mean Difference (Final Values)|-0.023||||0.55|TWO_SIDED||||||t-test, 2 sided|||Comparison of baseline differences||||0.55
91540878|NCT02527148|182960919|SUPERIORITY||Mean Difference (Final Values)|-0.043||||0.23|TWO_SIDED||||||t-test, 2 sided|||Analysis of QALY between each instrument platform at 12-months||||0.23
91540879|NCT02527148|182960920|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.724|||||||t-test, 2 sided|||To compare VAS rest preoperatively between both groups.||||0.7240
91540880|NCT02527148|182960920|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.7545|||||||t-test, 2 sided|||To compare VAS mobilisation preoperatively between both groups.||||0.7545
91540881|NCT02527148|182960920|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6921|||||||t-test, 2 sided|||To compare VAS rest at 6 weeks between both groups.||||0.6921
91540882|NCT02527148|182960920|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.9601|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 weeks between both groups.||||0.9601
91540883|NCT02527148|182960920|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0697|||||||t-test, 2 sided|||To compare VAS rest at 6 months between both groups.||||0.0697
91540884|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0342|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 months between both groups.||||0.0342
91540885|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.3487|||||||t-test, 2 sided|||To compare VAS rest at 12 months between both groups.||||0.3487
91540886|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2201|||||||t-test, 2 sided|||To compare VAS mobilisation at 1 year between both groups.||||0.2201
91540887|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2291|||||||t-test, 2 sided|||To compare VAS rest at 2 years between both groups.||||0.2291
91540888|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6436|||||||t-test, 2 sided|||To compare VAS mobilisation at 2 years between both groups.||||0.6436
91540889|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.4344|||||||t-test, 2 sided|||To compare VAS rest at 5 years between both groups.||||0.4344
91540890|NCT02527148|182960920|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.8732|||||||t-test, 2 sided|||To compare VAS mobilisation at 5 years between both groups.||||0.8732
91540891|NCT02527148|182960921|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||To compare WOMAC preoperatively between both groups.||||0.911
91540892|NCT02527148|182960921|SUPERIORITY|||||||0.588|||||||t-test, 2 sided|||To compare WOMAC at 6-weeks between both groups.||||0.588
91540893|NCT02527148|182960921|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||To compare WOMAC at 6-months between both groups.||||0.030
91540894|NCT02527148|182960921|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||To compare WOMAC at 1-year between both groups.||||0.131
91540895|NCT02527148|182960921|SUPERIORITY|||||||0.347|||||||t-test, 2 sided|||To compare WOMAC at 2-years between both groups.||||0.347
91540896|NCT02527148|182960921|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||To compare WOMAC at 5-years between both groups.||||0.341
91540897|NCT02527148|182960922|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||To compare EQ-5D index preoperatively between both groups.||||0.452
91540898|NCT02527148|182960922|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.201
91540899|NCT02527148|182960922|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||To compare EQ-5D index at 6-weeks between both groups.||||0.741
91540900|NCT02527148|182960922|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-weeks between both groups.||||0.794
91540901|NCT02527148|182960922|SUPERIORITY|||||||0.232|||||||t-test, 2 sided|||To compare EQ-5D index at 6-months between both groups.||||0.232
91540902|NCT02527148|182960922|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-months between both groups.||||0.513
91540903|NCT02527148|182960922|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||To compare EQ-5D index at 1-year between both groups.||||0.180
91540904|NCT02527148|182960922|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||To compare EQ-5D VAS at 1-year between both groups.||||0.864
91540905|NCT02527148|182960922|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare EQ-5D index at 2-year between both groups.||||0.223
91540906|NCT02527148|182960922|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||To compare EQ-5D VAS at 2-year between both groups.||||0.355
91540907|NCT02527148|182960922|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||To compare EQ-5D index at 5-year between both groups.||||0.314
91540908|NCT02527148|182960922|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||To compare EQ-5D VAS at 5-year between both groups.||||0.914
91540909|NCT02527148|182960923|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||To compare FJS at 6-weeks between both groups.||||0.523
91540910|NCT02527148|182960923|SUPERIORITY|||||||0.932|||||||t-test, 2 sided|||To compare FJS at 6-months between both groups.||||0.932
91540911|NCT02527148|182960923|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||To compare FJS at 1-year between both groups.||||0.934
91540912|NCT02527148|182960923|SUPERIORITY|||||||0.566|||||||t-test, 2 sided|||To compare FJS at 2-year between both groups.||||0.566
91540913|NCT02527148|182960923|SUPERIORITY|||||||0.263|||||||t-test, 2 sided|||To compare FJS at 5-year between both groups.||||0.263
91540914|NCT02527148|182960924|SUPERIORITY|||||||0.3768|||||||t-test, 2 sided|||To compare IKSS Pain preoperatively between both groups.||||0.3768
91540915|NCT02527148|182960924|SUPERIORITY|||||||0.6425|||||||t-test, 2 sided|||To compare IKSS Function preoperatively between both groups.||||0.6425
91540916|NCT02527148|182960924|SUPERIORITY|||||||0.5041|||||||t-test, 2 sided|||To compare IKSS ROM preoperatively between both groups.||||0.5041
91540917|NCT02527148|182960924|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare IKSS Pain at 6-weeks between both groups.||||0.2230
91540918|NCT02527148|182960924|SUPERIORITY|||||||0.8209|||||||t-test, 2 sided|||To compare IKSS Function at 6-weeks between both groups.||||0.8209
91540919|NCT02527148|182960924|SUPERIORITY|||||||0.6958|||||||t-test, 2 sided|||To compare IKSS ROM at 6-weeks between both groups.||||0.6958
91540920|NCT02527148|182960924|SUPERIORITY|||||||0.0548|||||||t-test, 2 sided|||To compare IKSS Pain at 6-months between both groups.||||0.0548
91540921|NCT02527148|182960924|SUPERIORITY|||||||0.1958|||||||t-test, 2 sided|||To compare IKSS Function at 6-months between both groups.||||0.1958
91540922|NCT02527148|182960924|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||To compare IKSS ROM at 6-months between both groups.||||0.2786
91763810|NCT02534909|183418271|OTHER|Bayesian analysis of response rate in serum LDH (period 1 completers only)|Median response rate|99.0|||||TWO_SIDED|95.0|81.9|100.0|||||95% Credibility Interval for Response Rate|Up to Week 4||100.0|81.9|
91763811|NCT02534909|183418272|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 1 Day 29 serum LDH levels||0.23|0.15|<0.001
91763812|NCT02534909|183418272|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 2 Day 365 serum LDH levels||0.23|0.15|<0.001
91540923|NCT02527148|182960924|SUPERIORITY|||||||0.2399|||||||t-test, 2 sided|||To compare IKSS Pain at 1-year between both groups.||||0.2399
91540924|NCT02527148|182960924|SUPERIORITY|||||||0.4135|||||||t-test, 2 sided|||To compare IKSS Function at 1-year between both groups.||||0.4135
91540925|NCT02527148|182960924|SUPERIORITY|||||||0.5278|||||||t-test, 2 sided|||To compare IKSS ROM at 1-year between both groups.||||0.5278
91540926|NCT02527148|182960924|SUPERIORITY|||||||0.2992|||||||t-test, 2 sided|||To compare IKSS Pain at 2-year between both groups.||||0.2992
91540927|NCT02527148|182960924|SUPERIORITY|||||||0.5462|||||||t-test, 2 sided|||To compare IKSS Function at 2-year between both groups.||||0.5462
91540928|NCT02527148|182960924|SUPERIORITY|||||||0.5765|||||||t-test, 2 sided|||To compare IKSS ROM at 2-year between both groups.||||0.5765
91540929|NCT02527148|182960924|SUPERIORITY|||||||0.5493|||||||t-test, 2 sided|||To compare IKSS Pain at 5-year between both groups.||||0.5493
91540930|NCT02527148|182960924|SUPERIORITY|||||||0.1705|||||||t-test, 2 sided|||To compare IKSS Function at 5-year between both groups.||||0.1705
91540931|NCT02527148|182960924|SUPERIORITY|||||||0.2918|||||||t-test, 2 sided|||To compare IKSS ROM at 5-year between both groups.||||0.2918
91540932|NCT02527148|182960925|OTHER|||||||0.6|||||||t-test, 2 sided|||Comparison of coronal mechanical axis:hip knee ankle angle between both groups.||||0.6
91540933|NCT02527148|182960925|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison of coronal angle fem comp and mech axis femur between both groups.||||0.002
91540934|NCT02527148|182960925|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of coronal angle tibial comp and mech axis tibia between both groups.||||<0.001
91540935|NCT02527148|182960925|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of sagital tibial component slope between both groups.||||<0.001
91540936|NCT02527148|182960925|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups.||||<0.001
91540937|NCT02918279|182960926|SUPERIORITY||Treatment difference|-0.22||||0.0022|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA||Liraglutide 3.0 mg - Placebo|Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.||-0.08|-0.37|0.0022
91540938|NCT01641198|182961010|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.59|0.01||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.01|-0.59|<0.05
91540939|NCT01641198|182961010|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|95.0|0.09|0.69||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.69|0.09|<0.05
91540940|NCT01641198|182961010|SUPERIORITY||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.98|-0.39||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.39|-0.98|<0.05
91763813|NCT02534909|183418272|OTHER||Geometric LS mean Ratio to Baseline|0.17|||<|0.001|TWO_SIDED|95.0|0.14|0.2|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 3 Day 1429 serum LDH levels||0.20|0.14|<0.001
91763814|NCT02534909|183418272|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 4 Day 141 serum LDH levels||0.24|0.15|<0.001
91540941|NCT01641198|182961011|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-0.47|0.13||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.13|-0.47|<0.05
91540942|NCT01641198|182961011|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|0.26|0.85||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.85|0.26|<0.05
91540943|NCT01641198|182961011|SUPERIORITY||Mean Difference (Final Values)|-0.725|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-1.02|-0.43||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.43|-1.02|<0.05
91540944|NCT01641198|182961012|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-0.19|0.59||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.59|-0.19|<0.05
91540945|NCT01641198|182961012|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|0.45|1.22||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||1.22|0.45|<0.05
91540946|NCT01641198|182961012|SUPERIORITY||Mean Difference (Final Values)|-0.635|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-1.01|-0.26||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI).||-0.26|-1.01|<0.05
91540947|NCT00346151|182961030|SUPERIORITY_OR_OTHER||Incidence Rate|60.0||||||95.0|15.0|95.0|||95% exact binomial CI of proportion|||Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.||95|15|
91540948|NCT00346151|182961031|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
91540949|NCT00346151|182961032|SUPERIORITY_OR_OTHER||Incidence rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
91540950|NCT00346151|182961035|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
91540951|NCT00346151|182961037|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
91540952|NCT00346151|182961038|SUPERIORITY_OR_OTHER||Incidence Rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
91540953|NCT00346151|182961039|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
91540954|NCT00346151|182961040|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
91540955|NCT00346151|182961041|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|47.8|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|47.8|
91540956|NCT00346151|182961042|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
91540957|NCT00346151|182961043|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
91540958|NCT00346151|182961044|SUPERIORITY_OR_OTHER||Incidence Rate|20.0||||||95.0|0.5|71.6|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||71.6|0.5|
91540959|NCT01075217|182961045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.45|<|0.0001|TWO_SIDED|95.0|1.4|3.5||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 1, i.e., pain was not assessed separately from heat.|t-test, 2 sided|||||3.5|1.4|<0.0001
91540960|NCT01075217|182961045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|1.94||0.3244|TWO_SIDED|95.0|-0.5|1.4||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 2, i.e., pain was assessed separately from heat.|t-test, 2 sided|||||1.4|-0.5|0.3244
91540961|NCT01075217|182961046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.35||0.0059|TWO_SIDED|95.0|0.5|2.7|||t-test, 2 sided|||||2.7|0.5|0.0059
91540962|NCT03260140|182961052|SUPERIORITY||Mean Difference (Final Values)|-1.93||||0.001|TWO_SIDED|97.5|-3.24|-0.61|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||-0.61|-3.24|0.001
91540963|NCT03260140|182961053|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.388|TWO_SIDED|97.5|-1.11|2.49|||Mixed Models Analysis|Difference in average SF-12 PCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.49|-1.11|0.388
91540964|NCT03260140|182961054|SUPERIORITY||Sign test|1.76||||0.308|TWO_SIDED|95.0|0.85|3.66|||F test-ratio of 2 McNemar's Chi-Squares|||Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (\>=150 vs \<150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.||3.66|0.85|0.308
91540965|NCT03260140|182961055|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.396|TWO_SIDED|95.0|-0.61|0.24|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.24|-0.61|0.396
91540966|NCT03260140|182961056|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.657|TWO_SIDED|95.0|-1.02|1.61|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.61|-1.02|0.657
91540967|NCT03260140|182961057|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.281|TWO_SIDED|95.0|-2.33|0.68|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.68|-2.33|0.281
91540968|NCT03260140|182961058|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.483|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.23|-0.11|0.483
91540969|NCT03260140|182961059|SUPERIORITY||Mean percent change in HbA1c|0.02||||0.985|TWO_SIDED|95.0|-2.57|2.69|||Mixed Models Analysis|Difference in average HbA1c at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.69|-2.57|0.985
91763815|NCT00676013|183418310|OTHER|ANOVA and all pairwise comparisons using Tukey test.|Multiple pairwise comparisons|0.05||||0.05|TWO_SIDED|||||0.05 is a threshold for statistical significance.|ANOVA|||We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.|0.05|||0.05
91763816|NCT00577824|183418311|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as the covariate.||||||<0.001
91763817|NCT00577824|183418312|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
91763818|NCT00577824|183418313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
91763819|NCT00577824|183418314|SUPERIORITY_OR_OTHER||||||<|0.002||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||<0.002
91763820|NCT00577824|183418315|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||0.026
91763821|NCT00577824|183418316|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
91763822|NCT00577824|183418317|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||t-test, 2 sided|||||||0.580
91763823|NCT00577824|183418318|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
91763824|NCT00577824|183418319|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.490
91763825|NCT00577824|183418320|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
91763826|NCT00577824|183418321|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||t-test, 2 sided|||||||0.208
91763827|NCT00577824|183418323|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||t-test, 2 sided|||||||0.708
91763828|NCT00577824|183418324|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||t-test, 2 sided|||||||0.974
91763829|NCT00577824|183418326|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.200
91763830|NCT00577824|183418327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91540970|NCT03260140|182961060|SUPERIORITY||Mean Difference (Net)|-0.22||||0.806|TWO_SIDED|95.0|-1.99|1.55|||Mixed Models Analysis|Difference in average SF-12 MCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.55|-1.99|0.806
91540971|NCT03260140|182961061|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.62|TWO_SIDED|95.0|-1.77|1.05|||Mixed Models Analysis|Difference in average DBP at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.05|-1.77|0.620
91540972|NCT03260140|182961062|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.987|TWO_SIDED|95.0|-2.32|2.28|||Mixed Models Analysis|Difference in average SPB at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.28|-2.32|0.987
91540973|NCT01755949|182961063|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.038
91540974|NCT01755949|182961063|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.98
91540975|NCT01755949|182961063|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||difference between placebo and colchicine levels at day 28||||0.072
91540976|NCT01755949|182961064|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||placebo vs colchicine||||0.08
91540977|NCT01667796|182961082|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||univariate generalized estimating equati|||||||0.001
91540978|NCT01667796|182961082|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Adjusted for adherence, body mass index, and oral contraceptive use|Generalized estimating equation|||||||0.008
91540979|NCT01444417|182961090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0497||||0.0018|TWO_SIDED|95.0|1.896|43.199|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||43.199|1.896|0.0018
91540980|NCT01444417|182961091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0443||||0.0002|TWO_SIDED|95.0|2.535|32.265|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||32.265|2.535|0.0002
91540981|NCT01444417|182961092|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).||||||0.0004
91540982|NCT01444417|182961093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.813||||0.7103|TWO_SIDED|95.0|0.277|2.391|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group||||2.391|0.277|0.7103
91540983|NCT01214824|182961103|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.014||95.0|||||Wilcoxon signed rank test|||Comparison is HbA1c at 6 months versus Baseline||||0.014
91540984|NCT01214824|182961105|SUPERIORITY_OR_OTHER|||||||0.5304||95.0|||||Paired t-test|||Comparison is masked phase 2 versus masked phase 1||||0.5304
91540985|NCT02214160|182961107|SUPERIORITY|||||||0.0347|||||||Paired T-test|||||||0.0347
91540986|NCT02214160|182961108|SUPERIORITY|||||||0.0343|||||||Wilcoxon Signed Rank Test|||||||0.0343
91540987|NCT01063972|182961124|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
91540988|NCT01063972|182961125|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
91540989|NCT01063972|182961126|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
91540990|NCT01063972|182961127|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
91540991|NCT00442117|182961189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.074||||0.4982|TWO_SIDED|95.0|-4.196|2.049|||ANOVA|||||2.049|-4.196|0.4982
91540992|NCT00442117|182961190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7601||||0.6544|TWO_SIDED|95.0|-2.585|4.106|||ANOVA|||||4.106|-2.585|0.6544
91540993|NCT00442117|182961191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.704||||0.3796|TWO_SIDED|95.0|-5.528|2.115|||ANOVA|||||2.115|-5.528|0.3796
91540994|NCT00442117|182961192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.432||||0.9622|TWO_SIDED|95.0|-17.56|18.24|||ANOVA|||||18.240|-17.560|0.9622
91540995|NCT01499654|182961198|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
91540996|NCT01499654|182961198|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.67
91540997|NCT01499654|182961199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91540998|NCT01499654|182961199|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
91540999|NCT01499654|182961200|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91541000|NCT01499654|182961200|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
91541001|NCT01499654|182961201|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
91541002|NCT01499654|182961201|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
91541003|NCT02763319|182961223|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.468|TWO_SIDED|95.0|0.837|1.351|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System (IWRS). Rituximab + bendamustine was the reference treatment group.|||1.351|0.837|0.468
91541004|NCT02763319|182961224|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.568|TWO_SIDED|95.0|0.586|1.33|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System. Rituximab + bendamustine is the reference treatment group.|||1.330|0.586|0.568
91541005|NCT02763319|182961225|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.812|1.779|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.779|0.812|
91541006|NCT02763319|182961226|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.778|3.041|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.041|0.778|
91541007|NCT02763319|182961227|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.938|1.745|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.745|0.938|
91541008|NCT02763319|182961228|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.673|2.035|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|2.035|0.673|
91541009|NCT02763319|182961229|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.875|1.452|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.452|0.875|
91541010|NCT02763319|182961230|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.682|1.626|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.626|0.682|
91541011|NCT02763319|182961231|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.829|1.985|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.985|0.829|
91541012|NCT02763319|182961232|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.755|3.457|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.457|0.755|
91541013|NCT02763319|182961233|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.831|1.416|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.416|0.831|
91541014|NCT02763319|182961234|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.633|1.595|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.595|0.633|
91541015|NCT02763319|182961235|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.794|1.244|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.244|0.794|
91541016|NCT02763319|182961236|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.57|1.22|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.220|0.570|
91541017|NCT00722046|182961287|SUPERIORITY||Least Squares (LS) Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|3.04||0.6504|TWO_SIDED|90.0|-3.68|6.45|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.45|-3.68|0.6504
91541018|NCT00722046|182961287|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|3.13||0.5213|TWO_SIDED|90.0|-3.2|7.23|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.23|-3.20|0.5213
91541019|NCT00722046|182961287|SUPERIORITY||LS Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|3.13||0.4698|TWO_SIDED|90.0|-2.94|7.48|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.48|-2.94|0.4698
91541020|NCT00722046|182961287|SUPERIORITY||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.66||0.5183|TWO_SIDED|90.0|-2.71|6.17|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.17|-2.71|0.5183
91541021|NCT00722046|182961287|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.7529|TWO_SIDED|90.0|-3.65|5.35|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.35|-3.65|0.7529
91541022|NCT00722046|182961289|SUPERIORITY||LS Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|5.59||0.4688|TWO_SIDED|90.0|-13.38|5.24|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.24|-13.38|0.4688
91541023|NCT00722046|182961289|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|5.64||0.9743|TWO_SIDED|90.0|-9.59|9.22|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||9.22|-9.59|0.9743
91541024|NCT00722046|182961289|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|5.65||0.8824|TWO_SIDED|90.0|-8.57|10.25|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.25|-8.57|0.8824
91541025|NCT00722046|182961289|SUPERIORITY||LS Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|5.81||0.4831|TWO_SIDED|90.0|-13.77|5.58|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.58|-13.77|0.4831
91541026|NCT00722046|182961289|SUPERIORITY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|5.88||0.9562|TWO_SIDED|90.0|-9.48|10.13|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.13|-9.48|0.9562
91541027|NCT00516321|182961319|SUPERIORITY_OR_OTHER||Percentage difference in SVR|7.9||||0.0064|TWO_SIDED|95.0|2.4|13.4||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||13.4|2.4|0.0064
91541028|NCT00373386|182961342|SUPERIORITY_OR_OTHER|||||||0.644|||||||t-test, 2 sided|||compared with baseline||||0.644
91541029|NCT00373386|182961343|SUPERIORITY_OR_OTHER|||||||0.018||||||Versus baseline|t-test, 2 sided|paired||Compared with baseline||||0.018
91541030|NCT00373386|182961344|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison to baseline||||0.04
91541031|NCT00373386|182961345|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison with baseline||||0.004
91541032|NCT00373386|182961346|SUPERIORITY_OR_OTHER|||||||0.804|||||||t-test, 2 sided|||Comparison with baseline||||0.804
91541033|NCT00373386|182961347|SUPERIORITY_OR_OTHER|||||||0.095|||||||t-test, 2 sided|||Comparison with baseline||||0.095
91541034|NCT00373386|182961348|SUPERIORITY_OR_OTHER|||||||0.648|||||||t-test, 2 sided|||Comparison with baseline||||0.648
91541035|NCT01925469|182961358|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.||An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.||||0.43
91541036|NCT01925469|182961359|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.||||0.4
91541037|NCT01925469|182961360|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
91541038|NCT01308567|182961361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.7574|TWO_SIDED|95.0|0.819|1.16||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.16|0.819|0.7574
91541039|NCT01308567|182961361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.009||||0.9967|TWO_SIDED|95.0|0.85|1.197||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.197|0.85|0.9967
91541040|NCT01308567|182961362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.849|1.152|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.152|0.849|
91541041|NCT01308567|182961362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|0.913|1.236|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.236|0.913|
91541042|NCT01308567|182961363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|||||TWO_SIDED|95.0|0.785|1.17|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.17|0.785|
91541043|NCT01308567|182961363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916|||||TWO_SIDED|95.0|0.75|1.118|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.118|0.75|
91541044|NCT01308567|182961365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948|||||TWO_SIDED|95.0|0.8|1.123|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.123|0.8|
91541045|NCT01308567|182961365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|||||TWO_SIDED|95.0|0.886|1.238|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.238|0.886|
91541046|NCT01308567|182961367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.986|1.434|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.434|0.986|
91541047|NCT01308567|182961367|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.985|1.435|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.435|0.985|
91541048|NCT01308567|182961369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121|||||TWO_SIDED|95.0|0.886|1.417|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.417|0.886|
91541049|NCT01308567|182961369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.798|1.288|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.288|0.798|
91541050|NCT02512965|182961495|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.79|6.69||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factor at randomization.|||6.69|1.79|0.0002
91541051|NCT02512965|182961496|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0036|TWO_SIDED|95.0|1.35|4.85|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factors at randomization.|||4.85|1.35|0.0036
91541052|NCT02512965|182961497|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.26|TWO_SIDED|95.0|0.46|1.24|||Log Rank|2-sided p-value adjusted for stratification factors at randomization.|Estimate adjusted for stratification factors at randopmization.|||1.24|0.46|0.26
91541053|NCT02512965|182961498|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|95.0|0.48|1.4||2-sided p-value adjusted for stratification factors at randomization.|Log Rank|||||1.40|0.48|0.47
91541054|NCT04303156|182961499|OTHER||GMR|2.2|||||TWO_SIDED|90.0|1.68|2.88|||||Severe Renal Impairment / Healthy|Geometric mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.88|1.68|
91541055|NCT04303156|182961500|OTHER||GMR|1.93|||||TWO_SIDED|90.0|1.46|2.55|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.55|1.46|
91541056|NCT04303156|182961501|OTHER||GMR|1.03|||||TWO_SIDED|90.0|0.67|1.57|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.57|0.67|
91541057|NCT04303156|182961504|OTHER||GMR|0.46|||||TWO_SIDED|90.0|0.35|0.6|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.60|0.35|
91541058|NCT04303156|182961505|OTHER||GMR|0.8|||||TWO_SIDED|90.0|0.56|1.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.56|
91541059|NCT04303156|182961506|OTHER||GMR|1.48|||||TWO_SIDED|90.0|1.03|2.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.14|1.03|
91541060|NCT04303156|182961507|OTHER||GMR|1.38|||||TWO_SIDED|90.0|0.98|1.93|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.93|0.98|
91541061|NCT04303156|182961508|OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.64|1.39|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.39|0.64|
91541062|NCT04303156|182961510|OTHER||GMR|0.97|||||TWO_SIDED|90.0|0.69|1.35|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.35|0.69|
91541063|NCT04303156|182961511|OTHER||GMR|1.82|||||TWO_SIDED|90.0|0.55|6.02|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|6.02|0.55|
91541064|NCT04303156|182961512|OTHER||GMR|2.69|||||TWO_SIDED|90.0|1.51|4.8|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|4.80|1.51|
91541065|NCT04283552|182961536|SUPERIORITY|||||||0.001|||||||Two-tailed Wildoxon signed-rank test|||This statistical analysis is for Reader 1.||||0.001
91541066|NCT04283552|182961536|SUPERIORITY|||||||0.28|||||||Two-tailed Wilcoxon signed-rank test|||This statistical analysis is for Reader 2.||||0.28
91541067|NCT04283552|182961537|SUPERIORITY|||||||0.22|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.22
91541068|NCT04283552|182961537|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||>0.05
91541069|NCT04283552|182961538|SUPERIORITY|||||||0.009|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.009
91541070|NCT04283552|182961538|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This statistical analysis is for Reader 2.||||>0.05
91541071|NCT04283552|182961539|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
91541072|NCT04283552|182961539|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
91541073|NCT04283552|182961540|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
91541074|NCT04283552|182961540|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
91541075|NCT04283552|182961543|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 1 to PS-Late Reader 1.||||<0.001
91541076|NCT04283552|182961543|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 2 and PS-Late Reader 2.||||<0.001
91541077|NCT01852071|182961551|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
91541078|NCT01852071|182961551|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||||
91541079|NCT01852071|182961551|SUPERIORITY||Difference in percentages|7.69|||||TWO_SIDED|95.0|-10.08|25.13||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||25.13|-10.08|
91541080|NCT01852071|182961552|SUPERIORITY||Difference in percentages|35.71|||||TWO_SIDED|95.0|11.21|64.86||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||64.86|11.21|
91541081|NCT01852071|182961552|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||||
91541082|NCT01852071|182961552|SUPERIORITY||Difference in percentages|19.23|||||TWO_SIDED|95.0|0.71|39.35||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||39.35|0.71|
91541083|NCT01852071|182961553|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
91541084|NCT01852071|182961553|SUPERIORITY||Difference in percentages|9.09|||||TWO_SIDED|95.0|-9.55|41.28||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||41.28|-9.55|
91541085|NCT01852071|182961553|SUPERIORITY||Difference in percentages|12.0|||||TWO_SIDED|95.0|-5.62|31.22||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||31.22|-5.62|
91541086|NCT01852071|182961554|SUPERIORITY||Difference in percentages|50.0|||||TWO_SIDED|95.0|22.71|76.96||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||76.96|22.71|
91541087|NCT01852071|182961554|SUPERIORITY||Difference in percentages|36.36|||||TWO_SIDED|95.0|9.8|69.21||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||69.21|9.80|
91541088|NCT01852071|182961554|SUPERIORITY||Difference in percentages|44.0|||||TWO_SIDED|95.0|22.78|65.23||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||65.23|22.78|
91541089|NCT02755116|182961587|SUPERIORITY||Adjusted relative risk|0.76||||0.003|TWO_SIDED|95.0|0.48|1.2|||log-binomial regression|||||1.20|0.48|0.003
91541090|NCT02423798|182961596|OTHER||Mean|9.13|||||TWO_SIDED|||||||||||||
91541091|NCT00392054|182961606|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.0016|TWO_SIDED|95.0|0.35|0.9||Cox regression analysis, stratified by clinical site, was performed and presented as hazard ratios with 95% confidence intervals and a two-sided p-value testing of less than or equal to 0.05 (two-sided) for the Wald test.|Regression, Cox|||Event rates were plotted over time using Kaplan-Meier methodology. Only events occurring after the 90-day treatment period were included in the final analysis. Treatment groups were analyzed on an intention-to-treat basis.||0.90|0.35|0.0016
91541092|NCT00392054|182961608|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.03|TWO_SIDED|95.0|0.33|0.95|||Regression, Cox|||||0.95|0.33|0.03
91541093|NCT00392054|182961609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.017|TWO_SIDED|95.0|0.3|0.89|||Regression, Cox|||||0.89|0.3|0.017
91541094|NCT00392054|182961610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.28|0.4|||Regression, Cox|||||0.4|0.28|<0.0001
91541095|NCT00392054|182961611|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.66|TWO_SIDED|95.0|0.42|1.72|||Regression, Cox|||||1.72|0.42|0.66
91541096|NCT03073941|182961650|NON_INFERIORITY|A non-Inferiority analysis was performed once the 1 year OKS of the first 216 patients were collected. A one-sided T-test, 90% power, SD=10 and with a non-inferiority margin of 4 OKS was used and the analysis was based on the difference of average OKS between Persona and NexGen 1 year postoperatively.|||||<|0.05|||||||t-test, 1 sided|90% power, SD=10 and with a non-inferiority margin of 4 OKS||||||<0.05
91541097|NCT04250883|182961660|SUPERIORITY|||||||0.54|||||||Chi-squared, Corrected|for age||||||0.54
91541098|NCT04250883|182961661|SUPERIORITY|||||||0.97|||||||Chi-squared, Corrected|for age||||||0.97
91541099|NCT04250883|182961663|SUPERIORITY|||||||0.64||||||At 12 days postoperative|Chi-squared, Corrected|for age||||||0.64
91541100|NCT04250883|182961663|SUPERIORITY|||||||0.38||||||At 3 months postoperative|Chi-squared, Corrected|for age||||||0.38
91541101|NCT04250883|182961664|SUPERIORITY|||||||0.84|||||||Chi-squared, Corrected|For age||Count of patients with or without pain at 3 months postoperative||||0.84
91541102|NCT04250883|182961664|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||Number of Words Chosen||||0.89
91541103|NCT04250883|182961664|SUPERIORITY|||||||0.98|||||||ANCOVA|Correction for age||Pain Rating index||||0.98
91541104|NCT04250883|182961665|SUPERIORITY|||||||0.9|||||||ANCOVA|Correction for age||||||0.9
91541105|NCT04250883|182961666|SUPERIORITY|||||||0.68|||||||ANCOVA|Correction for age||At 1 hour||||0.68
91541106|NCT04250883|182961666|SUPERIORITY|||||||0.91|||||||ANCOVA|Correction for age||At 6 hours||||0.91
91541107|NCT04250883|182961666|SUPERIORITY|||||||0.73|||||||ANCOVA|Correction for age||||||0.73
91541108|NCT04250883|182961666|SUPERIORITY|||||||0.77|||||||ANCOVA|Correction for age||||||0.77
91541109|NCT04250883|182961667|SUPERIORITY|||||||0.63|||||||ANCOVA|Correction for age||At 1 hour||||0.63
91541110|NCT04250883|182961667|SUPERIORITY|||||||0.19|||||||ANCOVA|Correction for age||At postoperative day 1||||0.19
91541111|NCT04250883|182961668|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||At 1 hour||||0.89
91541112|NCT04250883|182961668|SUPERIORITY|||||||0.49|||||||ANCOVA|Correction for age||At postoperative day 1||||0.49
91541113|NCT04250883|182961669|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
91541114|NCT04250883|182961670|SUPERIORITY|||||||0.92|||||||ANCOVA|Correction for age||Of Total complications within 30 days postoperative||||0.92
91541115|NCT04250883|182961671|SUPERIORITY|||||||0.098|||||||ANCOVA|correction for age||Time to maximal intensity||||0.098
91541116|NCT04250883|182961671|SUPERIORITY|||||||0.008|||||||ANCOVA|correction for age||Angle from minimal to maximal intensity||||0.008
91541117|NCT04250883|182961671|SUPERIORITY|||||||0.042|||||||ANCOVA|correction for age||Delta between minimal and maximal intensity||||0.042
91541118|NCT04250883|182961672|SUPERIORITY|||||||0.35|||||||ANCOVA|Correction for age||postoperative day 1||||0.35
91541119|NCT04250883|182961672|SUPERIORITY|||||||0.52|||||||ANCOVA|Correction for age||at postoperative day 12||||0.52
91541120|NCT04250883|182961673|SUPERIORITY|||||||0.99|||||||ANCOVA|correction for age||at postoperative day 1||||0.99
91541121|NCT04250883|182961673|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||At postoperative day 12||||0.30
91541122|NCT04250883|182961674|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
91541123|NCT04250883|182961675|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||||||0.3
91541124|NCT04250883|182961676|SUPERIORITY|||||||0.33|||||||ANCOVA|Correction for age||||||0.33
91541125|NCT04250883|182961677|SUPERIORITY|||||||0.018|||||||ANCOVA|Correction for age||||||0.018
91541126|NCT00925587|182961698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.5 g/dL|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.427|0.052|||||Darbepoetin alfa QM - Darbepoetin alfa Q2W|Power = 90% at sample size calculation||0.052|-0.427|
91541127|NCT00774397|182961758|SUPERIORITY_OR_OTHER|||||||0.0537||95.0||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0537
91541128|NCT00774397|182961758|SUPERIORITY_OR_OTHER|||||||0.0213||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0213
91541129|NCT00774397|182961758|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
91541130|NCT00774397|182961758|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
91541131|NCT00774397|182961758|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
91541132|NCT00774397|182961758|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
91541133|NCT01599793|182961789|EQUIVALENCE|Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)||||||0.0016|||||||Mixed Models Analysis|||The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.||||0.0016
91541134|NCT01599793|182961791|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.36853||||0.3291|TWO_SIDED||||||t-test, 2 sided|||||||0.3291
91541135|NCT01599793|182961793|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0|Spearman Correlation Coefficients|-0.41818||||0.2006|TWO_SIDED||||||t-test, 2 sided|||||||0.2006
91541136|NCT01599793|182961795|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.17669||||0.5828|TWO_SIDED||||||t-test, 2 sided|||||||0.5828
91541137|NCT04040296|182961823|SUPERIORITY||Difference in percentage|1.4||||0.28|TWO_SIDED|95.0|-1.1|3.8|||Cochran-Mantel-Haenszel||Difference between arms in the percentage of subjects with the primary outcome within 14 days of randomization.|||3.8|-1.1|0.28
91541138|NCT04040296|182961824|SUPERIORITY||Difference in percentage|9.5|||<|0.001|TWO_SIDED|95.0|8.1|11.0|||Van Elteren test||Difference between arms in the percentage of implemented recommendations with 24 hours of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||11|8.1|<.001
91541139|NCT04040296|182961825|SUPERIORITY||Difference in percentage|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.6|||Van Elteren test||Difference between arms in the percentage of subjects with AKI progression within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.6|-1.6|.65
91541140|NCT04040296|182961826|SUPERIORITY||Difference in percentage|0.1||||0.89|TWO_SIDED|95.0|-0.7|0.8|||Van Elteren test||Difference between arms in the percentage of subjects who received inpatient dialysis within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.8|-.7|.89
91541141|NCT04040296|182961827|SUPERIORITY||Difference in percentage|0.4||||0.72|TWO_SIDED|95.0|-1.5|2.1|||Van Elteren test||Difference between arms in the percentage of subjects with inpatient mortality within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.1|-1.5|.72
91541142|NCT04040296|182961828|SUPERIORITY||Difference in percentage|1.9||||0.31|TWO_SIDED|95.0|-0.3|4.1|||Van Elteren test||Difference between arms in the percentage of subjects who received a kidney consult within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||4.1|-.3|.31
91541143|NCT04040296|182961829|SUPERIORITY||Difference in percentage|-0.9||||0.17|TWO_SIDED|95.0|-2.3|0.4|||Van Elteren test||Difference between arms in the percentage of subjects discharged to hospice care within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.4|-2.3|.17
91541144|NCT02652442|182961874|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the off-axis distance of 3.5 cm and 7.0 cm.||||0.97
91541145|NCT02652442|182961874|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation duration of 1 minute and 3 minutes.||||0.51
91541146|NCT02652442|182961874|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation schedule of daily OAR and biweekly OAR for a total of 5 sessions.||||0.44
91541147|NCT02252042|182961875|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0316|TWO_SIDED|95.0|0.67|1.01|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.01|0.67|0.03160
91541148|NCT02252042|182961876|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01605|TWO_SIDED|95.0|0.65|0.98||Nominal p-value|Log Rank||Nominal HR. Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.98|0.65|0.01605
91541149|NCT02252042|182961877|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00493|TWO_SIDED|95.0|0.58|0.93|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.93|0.58|0.00493
91541150|NCT02252042|182961878|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.32504|TWO_SIDED|95.0|0.79|1.16|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.16|0.79|0.32504
91541151|NCT02252042|182961879|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07736|TWO_SIDED|95.0|0.69|1.06|||Log Rank||Cox regression model with treatment as a single covariate|||1.06|0.69|0.07736
91541152|NCT02252042|182961880|SUPERIORITY||Difference in percentages|4.6||||0.061|TWO_SIDED|95.0|-1.2|10.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||10.6|-1.2|0.0610
91541153|NCT02252042|182961881|SUPERIORITY||Difference in percentages|7.5||||0.0171|TWO_SIDED|95.0|0.6|14.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||14.6|0.6|0.0171
91541154|NCT02252042|182961884|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.14545|TWO_SIDED|95.0|0.7|1.12||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.12|0.70|0.14545
91541155|NCT02252042|182961885|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.05851|TWO_SIDED|95.0|0.62|1.06||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.06|0.62|0.05851
91541156|NCT02252042|182961886|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.65759|TWO_SIDED|95.0|0.86|1.27|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.27|0.86|0.65759
91541157|NCT02252042|182961887|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.51982|TWO_SIDED|95.0|0.81|1.26|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.26|0.81|0.51982
91541158|NCT01636687|182961903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|53.3|||<|0.0001|TWO_SIDED|95.0|36.6|67.7|||Fisher Exact|||Response criterion: IGA 0/1||67.7|36.6|<0.0001
91541159|NCT01636687|182961903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|73.3|||<|0.0001|TWO_SIDED|95.0|58.8|83.9|||Fisher Exact|||Response Criterion: IGA 0/1||83.9|58.8|<0.0001
91541160|NCT01636687|182961903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|68.4|||<|0.0001|TWO_SIDED|95.0|53.1|79.8|||Fisher Exact|||Response criterion: PASI 75||79.8|53.1|<0.0001
91541161|NCT01636687|182961903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|83.4|||<|0.0001|TWO_SIDED|95.0|70.7|91.7|||Fisher Exact|||Response criterion: PASI 75||91.7|70.7|<0.0001
91541162|NCT00666276|182961942|SUPERIORITY_OR_OTHER||||||=|0.712|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs."||||=0.712
91541163|NCT00666276|182961943|SUPERIORITY_OR_OTHER||||||=|0.257|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs."||||=0.257
91541164|NCT00666276|182961944|SUPERIORITY_OR_OTHER||||||=|0.082|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs."||||=0.082
91541165|NCT00666276|182961945|SUPERIORITY_OR_OTHER||||||=|0.462|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs."||||=0.462
91541166|NCT00666276|182961946|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs."||||<0.001
91541167|NCT00666276|182961947|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs."||||=0.018
91541168|NCT00666276|182961948|SUPERIORITY_OR_OTHER||||||=|0.311|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs."||||=0.311
91541169|NCT00666276|182961949|SUPERIORITY_OR_OTHER||||||=|0.044|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs."||||=0.044
91541170|NCT00666276|182961950|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs."||||=0.008
91541171|NCT01039688|182961952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.73|-0.18||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.18|-0.73|0.0014
91541172|NCT01039688|182961952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0004|TWO_SIDED|95.0|-0.77|-0.23||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.23|-0.77|0.0004
91541173|NCT01039688|182961953|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.32|||<|0.0001|TWO_SIDED|95.0|6.81|19.82||A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||19.82|6.81|<0.0001
91541174|NCT01039688|182961953|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.25|||<|0.0001|TWO_SIDED|95.0|18.51|31.99||A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||31.99|18.51|<0.0001
91541175|NCT02594735|182962042|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
91541176|NCT02594735|182962043|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91541177|NCT02594735|182962044|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
91541178|NCT02594735|182962045|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91541179|NCT02594735|182962046|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91541180|NCT02594735|182962047|OTHER|||||||0.375|||||||t-test, 2 sided|||||||0.375
91541181|NCT02594735|182962048|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91541182|NCT02594735|182962049|OTHER|||||||0.044|||||||Sign test|Data was not normally distributed||||||0.044
91541183|NCT02594735|182962050|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
91541184|NCT03844269|182962062|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||EEG data excluded if excessive noise (rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch) at the pre- or post-intervention assessment||||<0.05
91541185|NCT00475319|182962076|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
91541186|NCT00475319|182962077|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
91541187|NCT03698708|182962082|SUPERIORITY||cohen's d|0.88|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91541188|NCT03698708|182962083|SUPERIORITY||cohen's d|0.22|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91541189|NCT03698708|182962084|SUPERIORITY||cohen's d|0.05|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91541190|NCT03698708|182962085|SUPERIORITY||cohen's d|0.14|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91541191|NCT03698708|182962086|SUPERIORITY||cohen's d|0.09|||||TWO_SIDED||||||repeated measures ANOVA|||||||
91541192|NCT03698708|182962087|SUPERIORITY||Mean Difference (Final Values)|-4.16|||||TWO_SIDED|95.0|-10.07|1.74|||ANOVA|||||1.74|-10.07|
91541193|NCT00364013|182962096|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.27||||0.0234||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.||||0.0234
91541194|NCT00364013|182962096|SUPERIORITY_OR_OTHER_LEGACY||Normal score|2.28||||0.0227||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0227
91541195|NCT00364013|182962097|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.8||||0.0723||||||cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0723
91541196|NCT00364013|182962097|SUPERIORITY_OR_OTHER_LEGACY||Normal score|1.83||||0.0678||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.||||0.0678
91541197|NCT00364013|182962098|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.0684|TWO_SIDED|95.0|0.98|1.87|||Stratified exact test|Adjusted for geographic region and ECOG score.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.87|0.98|0.0684
91541198|NCT00364013|182962098|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9822|TWO_SIDED|95.0|0.65|1.47|||Stratified exact test|Adjusted for geographic region and ECOG score|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.47|0.65|0.9822
91541199|NCT00891930|182962102|SUPERIORITY|||||||0.013|||||||Regression, Cox|||||||0.0130
91541200|NCT03873337|182962124|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 25||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at one-month post target quit date (2-months after baseline assessment.||||<0.001
91541201|NCT03873337|182962124|SUPERIORITY|||||||0.002||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at 3-months post target quit date (4 months after baseline assessment.||||0.002
91541202|NCT03873337|182962125|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at one-month post target quit date (2-months after baseline assessment.||||<0.001
91541203|NCT03873337|182962125|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at 3-months post target quit date (4-months after baseline assessment.||||<0.001
91541204|NCT01574807|182962129|SUPERIORITY||Percentage difference|0.0||||1|TWO_SIDED|||||Multiple McNemar tests corrected with Step-down Bonferroni method of Holm. A priori threshold for significance was 0.05.|McNemar|||||||1.00
91541205|NCT01185782|182962146|NON_INFERIORITY_OR_EQUIVALENCE|"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.)"|Delta|-3.51|||||TWO_SIDED|95.0|-13.05|6.04|||Chi-squared|||||6.04|-13.05|
91541206|NCT01185782|182962147|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Chi-squared|||||||0.214
91541207|NCT01185782|182962148|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||t-test, 2 sided|||||||0.087
91541208|NCT01185782|182962149|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||t-test, 2 sided|||||||0.069
91541209|NCT01185782|182962150|SUPERIORITY_OR_OTHER|||||||0.852||95.0|||||Chi-squared|||||||0.852
91541210|NCT01185782|182962151|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Chi-squared|||||||0.102
91541211|NCT01185782|182962152|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Chi-squared|||||||0.560
91541212|NCT01185782|182962153|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Chi-squared|||||||0.555
91541213|NCT01185782|182962154|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Chi-squared|||||||0.416
91541214|NCT02507752|182962158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||< 0.001
91541215|NCT02507752|182962158|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||ANOVA|||Mental component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||= 0.014
91541216|NCT02507752|182962160|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.021
91541217|NCT02507752|182962160|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
91541218|NCT02507752|182962161|SUPERIORITY_OR_OTHER||||||=|0.744|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.744
91541219|NCT02507752|182962161|SUPERIORITY_OR_OTHER||||||=|0.646|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.646
91541220|NCT02507752|182962162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541221|NCT02507752|182962162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541222|NCT02507752|182962163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541223|NCT02507752|182962163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541224|NCT02507752|182962164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541225|NCT02507752|182962164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541226|NCT02507752|182962165|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541227|NCT02507752|182962165|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541228|NCT02507752|182962166|SUPERIORITY_OR_OTHER||||||=|0.011|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.011
91541229|NCT02507752|182962166|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
91541230|NCT02507752|182962167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541231|NCT02507752|182962167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541232|NCT02507752|182962168|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
91541233|NCT02507752|182962168|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Mental component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
91541234|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.102|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.102
91541235|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
91541236|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Role physical domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
91541237|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Role physical domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541238|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
91541239|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
91541240|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.077|TWO_SIDED||||||ANOVA|||General health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.077
91541241|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||ANOVA|||General health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.068
91541242|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||ANOVA|||Vitality domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.018
91541243|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.053|TWO_SIDED||||||ANOVA|||Vitality domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.053
91541244|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
91541245|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
91541246|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.015
91541247|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.154|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.154
91541248|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.024|TWO_SIDED||||||ANOVA|||Mental health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.024
91541249|NCT02507752|182962169|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||ANOVA|||Mental health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.029
91541250|NCT01240330|182962186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.9|STANDARD_DEVIATION|7.46|<|0.0001|TWO_SIDED|95.0|16.3|21.59|||t-test, 1 sided|||The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.||21.59|16.30|<0.0001
91541251|NCT05082935|182962196|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.09|TWO_SIDED|95.0|-0.008|0.104|||ANCOVA|||||0.104|-0.008|0.09
91541252|NCT05082935|182962197|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.02|TWO_SIDED|95.0|0.02|0.29|||ANCOVA|||||0.29|0.02|0.02
91541253|NCT05082935|182962198|SUPERIORITY||Ratio of Means|-0.076||||0.03|TWO_SIDED|95.0|-0.145|-0.007|||ANCOVA|||||-0.007|-0.145|0.03
91541254|NCT05082935|182962199|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.38|TWO_SIDED|95.0|-0.04|0.09|||ANCOVA|||||0.09|-0.04|0.38
91541255|NCT05082935|182962200|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.002|TWO_SIDED|95.0|0.04|0.16|||ANCOVA|||||0.16|0.04|0.002
91541256|NCT02928224|182962206|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541257|NCT02928224|182962207|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541258|NCT02928224|182962208|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91541259|NCT02928224|182962217|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541260|NCT02928224|182962218|OTHER|||||||0.5958|||||||Stratified Log-rank|||||||0.5958
91541261|NCT02928224|182962219|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541262|NCT02928224|182962220|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541263|NCT02928224|182962221|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541264|NCT02928224|182962222|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
91541265|NCT02928224|182962223|OTHER|||||||0.1004|||||||Stratified Log-rank|||||||0.1004
91541266|NCT02928224|182962224|OTHER|||||||0.3724|||||||Stratified Log-rank|||||||0.3724
91541267|NCT02928224|182962225|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91541268|NCT02928224|182962226|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91541269|NCT02928224|182962227|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91541270|NCT02928224|182962228|OTHER|||||||0.1928|||||||Cochran-Mantel-Haenszel|||||||0.1928
91541271|NCT02928224|182962229|OTHER|||||||0.0357|||||||Cochran-Mantel-Haenszel|||||||0.0357
91541272|NCT00958633|182962303|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval \[CI\], 0.43 to 1.10; P = 0.12 by log-rank test).|||1.10|0.43|0.12
91541273|NCT00958633|182962304|SUPERIORITY||Hazard Ratio (HR)|2.28|||||TWO_SIDED|95.0|0.86|6.08||||||Manic or Hypomanic events||6.08|.86|
91541274|NCT00958633|182962304|SUPERIORITY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.25|0.75||||||Depressive Events||0.75|0.25|
91541275|NCT00094575|182962313|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.81|TWO_SIDED|95.0|0.77|1.22|||Log Rank||The HR was estimated by comparing Endovascular repair arm vs the Open repair arm.|The primary outcome was long-term, all-cause mortality. The sample size would provide 80% power to detect a 25% relative reduction in mortality at a two-sided alpha level of 0.05. The primary comparison was the main effects of Endovascular repair vs Open repair of AAA.||1.22|0.77|0.81
91541276|NCT00094575|182962314|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
91541277|NCT00094575|182962315|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
91541278|NCT00094575|182962316|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
91541279|NCT00094575|182962317|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
91541280|NCT00094575|182962318|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Note: Since this is measuring change over time since baseline, values could be below 0.||||0.58
91541281|NCT00094575|182962319|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
91541282|NCT00094575|182962320|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
91541283|NCT05938413|182962466|NON_INFERIORITY|Non-inferiority test to compare viral suppression rate between month 3 and baseline.|Odds Ratio (OR)|3.01|||||TWO_SIDED|||||||||||||
91541284|NCT03312907|182962469|OTHER||Odds Ratio (OR)|1.27||||0.5342|TWO_SIDED|95.0|0.6|2.71|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose. Belimumab + Standard therapy arm was excluded from model.|||2.71|0.60|0.5342
91541285|NCT03312907|182962469|OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.32|1.54|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, and Baseline prednisone equivalent dose. Belimumab + Placebo arm excluded from model.|||1.54|0.32|
91541286|NCT03312907|182962470|OTHER||Odds Ratio (OR)|1.12||||0.8582|TWO_SIDED|95.0|0.33|3.78|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||3.78|0.33|0.8582
91541287|NCT03312907|182962470|OTHER||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.17|1.7|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from model.|||1.70|0.17|
91541288|NCT03312907|182962471|OTHER||Odds Ratio (OR)|1.64||||0.3613|TWO_SIDED|95.0|0.57|4.72|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||4.72|0.57|0.3613
91541289|NCT03312907|182962471|OTHER||Odds Ratio (OR)|0.45|||||TWO_SIDED|95.0|0.19|1.09|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.09|0.19|
91541290|NCT03312907|182962477|OTHER||Hazard Ratio (HR)|0.81||||0.215|TWO_SIDED|95.0|0.57|1.13|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.13|0.57|0.2150
91541291|NCT03312907|182962477|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|1.03|2.63|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.63|1.03|
91541292|NCT03312907|182962478|OTHER||Hazard Ratio (HR)|0.87||||0.3757|TWO_SIDED|95.0|0.64|1.19|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.19|0.64|0.3757
91541293|NCT03312907|182962478|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.71|1.49|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.49|0.71|
91541294|NCT03312907|182962479|OTHER||Hazard Ratio (HR)|1.55||||0.5127|TWO_SIDED|95.0|0.42|5.78|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.78|0.42|0.5127
91541295|NCT03312907|182962479|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.23|2.1|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.10|0.23|
91541296|NCT03312907|182962480|OTHER||Hazard Ratio (HR)|0.83||||0.8436|TWO_SIDED|95.0|0.14|5.05|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.05|0.14|0.8436
91541297|NCT03312907|182962480|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.09|3.14|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||3.14|0.09|
91541298|NCT03312907|182962487|OTHER||Odds Ratio (OR)|1.55||||0.7102|TWO_SIDED|95.0|0.15|15.7|||Regression, Logistic|Week 52|Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab+ Standard therapy arm was excluded from the model.|||15.70|0.15|0.7102
91541299|NCT03312907|182962487|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.1|10.71|||||Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||10.71|0.10|
91541300|NCT03312907|182962487|OTHER||Odds Ratio (OR)|0.9||||0.8641|TWO_SIDED|95.0|0.26|3.15|||Regression, Logistic|Week 104|Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from the model.|||3.15|0.26|0.8641
91541301|NCT03312907|182962487|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.26|5.64|||||Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||5.64|0.26|
91763831|NCT00362648|183418328|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|39.3|||<|0.001||95.0|19.1|54.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||54.7|19.1|<0.001
91541302|NCT02576574|182962553|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.007|TWO_SIDED|95.0|0.54|0.93|||Log Rank|||||0.93|0.54|0.0070
91541303|NCT02576574|182962554|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0196|TWO_SIDED|95.0|0.52|0.98|||Log Rank|||||0.98|0.52|0.0196
91541304|NCT02576574|182962555|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1032|TWO_SIDED|95.0|0.67|1.09|||Log Rank|||||1.09|0.67|0.1032
91541305|NCT02576574|182962556|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.063|TWO_SIDED|95.0|0.59|1.07|||Log Rank|||||1.07|0.59|0.0630
91541306|NCT02576574|182962557|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0147|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||||0.98|0.62|0.0147
91541307|NCT02576574|182962558|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1753|TWO_SIDED|95.0|0.67|1.15|||Log Rank|||||1.15|0.67|0.1753
91541308|NCT02576574|182962559|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0257|TWO_SIDED|95.0|0.66|1.0|||Log Rank|||||1.00|0.66|0.0257
91541309|NCT02576574|182962560|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0809|TWO_SIDED|95.0|0.66|1.07|||Log Rank|||||1.07|0.66|0.0809
91541310|NCT02576574|182962561|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1294|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||||1.07|0.78|0.1294
91541311|NCT02576574|182962562|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2618|TWO_SIDED|95.0|0.79|1.13|||Log Rank|||||1.13|0.79|0.2618
91541312|NCT02576574|182962563|SUPERIORITY||Odds Ratio (OR)|1.41||||0.064|TWO_SIDED|95.0|0.91|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.91|0.0640
91541313|NCT02576574|182962564|SUPERIORITY||Odds Ratio (OR)|1.23||||0.2217|TWO_SIDED|95.0|0.73|2.07|||Cochran-Mantel-Haenszel|||||2.07|0.73|0.2217
91763832|NCT00362648|183418328|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|48.3|||<|0.001||95.0|22.3|66.1||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||66.1|22.3|<0.001
91541314|NCT02576574|182962565|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1912|TWO_SIDED|95.0|0.81|1.72|||Cochran-Mantel-Haenszel|||||1.72|0.81|0.1912
91541315|NCT02576574|182962566|SUPERIORITY||Odds Ratio (OR)|1.0||||0.4951|TWO_SIDED|95.0|0.64|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.64|0.4951
91541316|NCT01780298|182962632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.278|||<|0.0001|TWO_SIDED|95.0|-42.203|-30.352|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-30.352|-42.203|<0.0001
91541317|NCT01780298|182962632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.739|||<|0.0001|TWO_SIDED|95.0|-38.418|-27.06|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-27.060|-38.418|<0.0001
91541318|NCT01780298|182962632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.265|||<|0.0001|TWO_SIDED|95.0|-31.081|-19.449|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-19.449|-31.081|<0.0001
91541319|NCT01780298|182962632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.538||||0.1504|TWO_SIDED|95.0|-8.398|1.321|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1.321|-8.398|0.1504
91541320|NCT01780298|182962632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.474||||0.0002|TWO_SIDED|95.0|-11.207|-3.741|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-3.741|-11.207|0.0002
91541321|NCT01780298|182962632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.013|||<|0.0001|TWO_SIDED|95.0|-15.979|-6.046|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-6.046|-15.979|<0.0001
91541322|NCT01780298|182962633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.611|||<|0.0001|TWO_SIDED|95.0|-32.249|-22.973|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-22.973|-32.249|<0.0001
91541323|NCT01780298|182962633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.553|||<|0.0001|TWO_SIDED|95.0|-29.501|-19.604|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-19.604|-29.501|<0.0001
91541324|NCT01780298|182962633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.107|||<|0.0001|TWO_SIDED|95.0|-19.043|-9.17|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-9.170|-19.043|<0.0001
91541325|NCT01780298|182962633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.058||||0.0983|TWO_SIDED|95.0|-6.702|0.585|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.585|-6.702|0.0983
91541326|NCT01780298|182962633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.446|||<|0.0001|TWO_SIDED|95.0|-13.845|-7.047|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-7.047|-13.845|<0.0001
91541327|NCT01780298|182962633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.504|||<|0.0001|TWO_SIDED|95.0|-17.302|-9.707|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-9.707|-17.302|<0.0001
91541328|NCT01780298|182962634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.448|||<|0.0001|TWO_SIDED|95.0|28.374|52.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||52.521|28.374|<0.0001
91541329|NCT01780298|182962634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.538|||<|0.0001|TWO_SIDED|95.0|14.89|38.185|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||38.185|14.890|<0.0001
91541330|NCT01780298|182962634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.661||||0.0018|TWO_SIDED|95.0|7.997|33.324|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||33.324|7.997|0.0018
91541331|NCT01780298|182962634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.91||||0.0015|TWO_SIDED|95.0|5.534|22.286|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||22.286|5.534|0.0015
91541332|NCT01780298|182962634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.877||||0.1847|TWO_SIDED|95.0|-2.886|14.639|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||14.639|-2.886|0.1847
91541333|NCT01780298|182962634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.787||||0.0003|TWO_SIDED|95.0|9.536|30.038|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||30.038|9.536|0.0003
91541334|NCT01780298|182962635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2979.725||||0.1981|TWO_SIDED|95.0|-7560.258|1600.808|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1600.808|-7560.258|0.1981
91541335|NCT01780298|182962635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2317.131||||0.1956|TWO_SIDED|95.0|-1224.786|5859.048|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||5859.048|-1224.786|0.1956
91541336|NCT01780298|182962635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2396.589||||0.2077|TWO_SIDED|95.0|-1367.692|6160.87|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||6160.870|-1367.692|0.2077
91541337|NCT01780298|182962635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5296.856||||0.1154|TWO_SIDED|95.0|-11930.19|1336.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1336.478|-11930.190|0.1154
91541338|NCT01780298|182962635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-79.458||||0.8095|TWO_SIDED|95.0|-736.151|577.234|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||577.234|-736.151|0.8095
91541339|NCT01780298|182962635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5376.314||||0.1113|TWO_SIDED|95.0|-12030.714|1278.085|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||1278.085|-12030.714|0.1113
91541340|NCT01780298|182962636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.015|||<|0.0001|TWO_SIDED|95.0|4.51|7.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||7.521|4.510|<0.0001
91541341|NCT01780298|182962636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.845|||<|0.0001|TWO_SIDED|95.0|3.379|6.31|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||6.310|3.379|<0.0001
91541342|NCT01780298|182962636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.454|||<|0.0001|TWO_SIDED|95.0|1.923|4.984|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||4.984|1.923|<0.0001
91541343|NCT01780298|182962636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.171||||0.0418|TWO_SIDED|95.0|0.045|2.296|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||2.296|0.045|0.0418
91541344|NCT01780298|182962636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.391||||0.0357|TWO_SIDED|95.0|0.096|2.686|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||2.686|0.096|0.0357
91541345|NCT01780298|182962636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.562||||0.0001|TWO_SIDED|95.0|1.303|3.82|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||3.820|1.303|0.0001
91541346|NCT01780298|182962637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.633|||<|0.0001|TWO_SIDED|95.0|33.964|45.302|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||45.302|33.964|<0.0001
91541347|NCT01780298|182962637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.792|||<|0.0001|TWO_SIDED|95.0|29.761|41.822|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||41.822|29.761|<0.0001
91541348|NCT01780298|182962637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.167|||<|0.0001|TWO_SIDED|95.0|23.445|34.888|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||34.888|23.445|<0.0001
91541349|NCT01780298|182962637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.842||||0.0418|TWO_SIDED|95.0|0.147|7.536|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||7.536|0.147|0.0418
91541350|NCT01780298|182962637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.625||||0.0084|TWO_SIDED|95.0|1.763|11.487|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||11.487|1.763|0.0084
91541351|NCT01780298|182962637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.467|||<|0.0001|TWO_SIDED|95.0|5.888|15.045|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||15.045|5.888|<0.0001
91763833|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|78.3||||||95.0|71.7|84.0||||||Anti-rotavirus IgA||84.0|71.7|
91763834|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|18.5||||||95.0|13.3|24.8||||||Serotype G1||24.8|13.3|
91763835|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|9.0||||||95.0|5.3|14.0||||||Serotype G2||14.0|5.3|
91763836|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|6.3||||||95.0|3.3|10.8||||||Serotype G3||10.8|3.3|
91763837|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|26.5||||||95.0|20.3|33.3||||||Serotype G4||33.3|20.3|
91763838|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|14.4||||||95.0|9.7|20.2||||||Serotype P1A\[8\]||20.2|9.7|
91763839|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|20.1||||||95.0|14.4|27.0||||||Anti-rotavirus IgA||27.0|14.4|
91763840|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.2||||||Serotype G1||2.2|0.0|
91541352|NCT01780298|182962638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.929|||<|0.0001|TWO_SIDED|95.0|0.654|1.203|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.203|0.654|<0.0001
91541353|NCT01780298|182962638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.875|||<|0.0001|TWO_SIDED|95.0|0.609|1.141|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.141|0.609|<0.0001
91541354|NCT01780298|182962638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.649|||<|0.0001|TWO_SIDED|95.0|0.386|0.912|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.912|0.386|<0.0001
91541355|NCT01780298|182962638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.069||||0.3985|TWO_SIDED|95.0|-0.093|0.231|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.231|-0.093|0.3985
91541356|NCT01780298|182962638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.0267|TWO_SIDED|95.0|0.026|0.414|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.414|0.026|0.0267
91541357|NCT01780298|182962638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.305||||0.0036|TWO_SIDED|95.0|0.104|0.506|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.506|0.104|0.0036
91541358|NCT01780298|182962639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.564|||<|0.0001|TWO_SIDED|95.0|1.179|1.949|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.949|1.179|<0.0001
91541359|NCT01780298|182962639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.291|||<|0.0001|TWO_SIDED|95.0|0.924|1.658|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.658|0.924|<0.0001
91541360|NCT01780298|182962639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.073|||<|0.0001|TWO_SIDED|95.0|0.724|1.421|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||1.421|0.724|<0.0001
91541361|NCT01780298|182962639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276||||0.0282|TWO_SIDED|95.0|0.031|0.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.521|0.031|0.0282
91541362|NCT01780298|182962639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.207||||0.1223|TWO_SIDED|95.0|-0.057|0.471|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.471|-0.057|0.1223
91541363|NCT01780298|182962639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.492|||<|0.0001|TWO_SIDED|95.0|0.273|0.71|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.710|0.273|<0.0001
91541364|NCT01780298|182962640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.372|||<|0.0001|TWO_SIDED|95.0|0.269|0.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||0.478|0.269|<0.0001
91541365|NCT01780298|182962640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.256|||<|0.0001|TWO_SIDED|95.0|0.158|0.354|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||0.354|0.158|<0.0001
91541366|NCT01780298|182962640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136||||0.0199|TWO_SIDED|95.0|0.022|0.249|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.249|0.022|0.0199
91541367|NCT01780298|182962640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.117||||0.0247|TWO_SIDED|95.0|0.015|0.218|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.218|0.015|0.0247
91541368|NCT01780298|182962640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.0204|TWO_SIDED|95.0|0.019|0.221|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.221|0.019|0.0204
91541369|NCT01780298|182962640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.237|||<|0.0001|TWO_SIDED|95.0|0.127|0.347|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.347|0.127|<0.0001
91541370|NCT05286385|182962649|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.59|||TWO_SIDED|95.0|-6.29|0.29||||||||0.29|-6.29|
91541371|NCT05286385|182962650|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|8.03|||TWO_SIDED|95.0|-8.04|3.44||||||||3.44|-8.04|
91541372|NCT05286385|182962651|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|4.55|||TWO_SIDED|95.0|-2.95|3.55||||||||3.55|-2.95|
91541373|NCT05930782|182962684|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of Cmax falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|73.9|||||TWO_SIDED|90.0|48.32|113.02||||||||113.02|48.32|
91541374|NCT05930782|182962685|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratio (GMR)|75.41|||||TWO_SIDED|90.0|56.46|100.71||||||||100.71|56.46|
91541375|NCT05930782|182962686|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|86.45|||||TWO_SIDED|90.0|68.16|109.63||||||||109.63|68.16|
91541376|NCT05930782|182962687|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|77.67|||||TWO_SIDED|90.0|59.49|101.39||||||||101.39|59.49|
91541377|NCT05930782|182962688|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|55.24|||||TWO_SIDED|90.0|6.03|113.02|||||For AUC0-inf, the GMR and 90% CI values were unreliable as there was only 1 calculable value for the Test (Group 2) and 2 values for the Reference (Group 1) products.|||113.02|6.03|
91541378|NCT01391832|182962702|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 1-month follow-up.|t-value on group differences in change|-1.51|||>|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||>0.05
91541379|NCT01391832|182962702|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 3-month follow-up.|t-value on group differences in change|-2.05|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
91541380|NCT01391832|182962702|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 6-month follow-up.|t-value on group differences in change|-2.01|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
91541381|NCT01391832|182962703|SUPERIORITY||Mean Difference (Final Values)|-0.666|STANDARD_DEVIATION|0.7101||0.3422|TWO_SIDED|1.422|-0.7548|2.088||It is not adjusted for multiple comparisons.|t-test, 2 sided|degrees of freedom = 58|mean change from baseline to 6-month follow-up, rTMS Active - rTMS Sham|Null hypothesis test of differences in N2 micro-volt change from baseline to 6-month followup.||2.088|-0.7548|.3422
91541382|NCT01391832|182962703|OTHER|The analysis examined correlations in change in N2 and PTSD symptoms.|Slope|-0.3||||0.02|TWO_SIDED|||||Not adjusted|Regression, Linear|||The analysis examined the association between change in PTSD symptoms from baseline to 6-month follow-up and the change in N2 amplitude to the threatening stimulus from baseline to 6-month follow-up.|Correlations for the individual groups were active rTMS r(28)=-.373 and sham rTMS r(32)=-.296.|||0.02
91763841|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|1.0|6.8||||||Serotype G2||6.8|1.0|
91763842|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G3||5.9|0.6|
91763843|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G4||5.9|0.6|
91763844|NCT00362648|183418329|SUPERIORITY_OR_OTHER||Percentage|4.7||||||95.0|2.1|9.1||||||Serotype P1A\[8\]||9.1|2.1|
91763845|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|87.8||||||95.0|80.9|92.9||||||Anti-rotavirus IgA||92.9|80.9|
91763846|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|32.1||||||95.0|24.2|40.8||||||Serotype G1||40.8|24.2|
91763847|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|9.9||||||95.0|5.4|16.4||||||Serotype G2||16.4|5.4|
91763848|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|28.2||||||95.0|20.7|36.8||||||Serotype G3||36.8|20.7|
91763849|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|18.3||||||95.0|12.1|26.0||||||Serotype G4||26.0|12.1|
91763850|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|27.5||||||95.0|20.0|36.0||||||Serotype P1A\[8\]||36.0|20.0|
91763851|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|18.2||||||95.0|12.0|25.8||||||Anti-rotavirus IgA||25.8|12.0|
91541383|NCT01154985|182962704|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Armitage trend test|||Proportion of responders in the EPA-E 1800 mg and 2700 mg groups compared to the proportion of responders in the placebo group compared using the Cochran-Armitage trend test in the Efficacy Evaluable analysis set. P-value less than 5% 1-sided. A total sample size of 210 (70 per arm) was planned to give 80% power for detecting a positive dose-response slope among the 3 treatment arms at 12 months.||||0.57
91541384|NCT01154985|182962705|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.0137
91541385|NCT01154985|182962705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|||||TWO_SIDED|95.0|3.4|29.1||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||29.1|3.4|
91541386|NCT01154985|182962705|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0006
91541387|NCT01154985|182962705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||||TWO_SIDED|95.0|9.6|34.4||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||34.4|9.6|
91763852|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|2.3||||||95.0|0.5|6.5||||||Serotype G1||6.5|0.5|
91763853|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|0.8||||||95.0|0.0|4.1||||||Serotype G2||4.1|0.0|
91763854|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|0.8|7.6||||||Serotype G3||7.6|0.8|
91763855|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.8||||||Serotype G4||2.8|0.0|
91763856|NCT00362648|183418330|SUPERIORITY_OR_OTHER||Percentage|5.3||||||95.0|2.2|10.6||||||Serotype P1A\[8\]||10.6|2.2|
91541388|NCT01154985|182962706|SUPERIORITY_OR_OTHER|||||||0.1592|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.1592
91763857|NCT03375489|183418331|EQUIVALENCE|Equivalence was established for patient-reported quality of life if the 90% confidence interval for the estimated difference in means was within the margin of ±4 points on the Functional Assessment of Cancer Therapy - Lung Questionnaire.|Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|90.0|0.1|3.9||The a priori threshold for statistical significance was p\<0.05.|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.||3.9|0.1|0.04
91763858|NCT03375489|183418332|EQUIVALENCE|Equivalence was established for patient-reported communication with their clinicians about their end-of-life care preferences if the 90% confidence interval for the estimated difference in proportions was within the margin of ±8%.|Estimated Difference in Proportions|3.1||||0.26|TWO_SIDED|90.0|-1.8|8.1||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The difference between groups in the proportions of patients reporting that they communicated with their clinicians about their end-of-life care preferences was estimated using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||8.1|-1.8|0.26
91763859|NCT03375489|183418333|EQUIVALENCE|Equivalence was established for patient length of stay in hospice if the 90% confidence interval for the estimated difference in mean days was within the margin of ±6 days.|Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|90.0|-7.0|7.4||Bonferroni-adjusted p-value|Regression, Linear|||The difference in mean length of stay in hospice between groups was estimated using a linear regression model with a main effect for group assignment.||7.4|-7.0|0.46
91763860|NCT03375489|183418334|SUPERIORITY||Difference in estimated proportions|-13.0|||<|0.001|TWO_SIDED|95.0|-17.6|-8.6||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The proportion of palliative care visits with caregiver participation was compared using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||-8.6|-17.6|<0.001
91763861|NCT03375489|183418335|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.99|TWO_SIDED|95.0|-1.0|1.7||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||1.7|-1.0|>0.99
91763862|NCT03375489|183418336|SUPERIORITY||Mean Difference (Final Values)|0.4|||>|0.99|TWO_SIDED|95.0|-1.5|2.3||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||2.3|-1.5|>0.99
91763863|NCT03838978|183418347|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis.|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Noninferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \>0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
91763864|NCT03071393|183418353|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91541389|NCT01154985|182962706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||||TWO_SIDED|95.0|-3.8|23.0||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||23.0|-3.8|
91541390|NCT01154985|182962706|SUPERIORITY_OR_OTHER|||||||0.0153|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0153
91541391|NCT01154985|182962706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|3.1|28.9||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||28.9|3.1|
91541392|NCT00232180|182962723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.535|0.741||Using an adaptation of Haybittle-Peto stopping criterion adjusting for two interim analyses, p-value for final primary analysis will be compared to alpha=0.049. No adjustment in alpha will be made on parameters/endpoints other than primary endpoint.|Cox proportional hazard model|||Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, time from electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) and atrial fibrillation as covariates.||0.741|0.535|<0.0001
91541393|NCT00232180|182962725|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.552|0.757||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.757|0.552|<0.0001
91541394|NCT00232180|182962726|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.761||||0.0081|TWO_SIDED|95.0|0.622|0.932||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.932|0.622|0.0081
91541395|NCT00232180|182962727|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.757||||0.012|TWO_SIDED|95.0|0.609|0.941||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.941|0.609|0.0120
91541396|NCT00232180|182962728|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||<|0.0001|TWO_SIDED|95.0|0.673|0.876||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.876|0.673|<0.0001
91541397|NCT00232180|182962729|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|0.0001|TWO_SIDED|95.0|0.473|0.702||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.702|0.473|<0.0001
91763865|NCT03071393|183418354|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91763866|NCT03071393|183418355|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91763867|NCT03071393|183418356|SUPERIORITY||||||<|0.05||||||Uncorrected p values are reported.|Wilcoxon (Mann-Whitney)|||||||<0.05
91541398|NCT00232180|182962730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.751|||<|0.0001|TWO_SIDED|95.0|0.664|0.849||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.849|0.664|<0.0001
91541399|NCT00232180|182962731|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|||<|0.0001|TWO_SIDED|95.0|0.475|0.701||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.701|0.475|<0.0001
91541400|NCT00232180|182962732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.694|||<|0.0001|TWO_SIDED|95.0|0.598|0.806||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.806|0.598|<0.0001
91541401|NCT00232180|182962733|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.316||||0.2321|TWO_SIDED|95.0|0.839|2.064||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.064|0.839|0.2321
91541402|NCT00232180|182962734|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.789||||0.4213|TWO_SIDED|95.0|0.443|1.406||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.406|0.443|0.4213
91541403|NCT00232180|182962735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.994||||0.9754|TWO_SIDED|95.0|0.694|1.424||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.424|0.694|0.9754
91541404|NCT00232180|182962736|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.2652|TWO_SIDED|95.0|0.485|1.22||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.220|0.485|0.2652
91541405|NCT00232180|182962737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.971||||0.9537|TWO_SIDED|95.0|0.366|2.578||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.578|0.366|0.9537
91763868|NCT00286429|183418369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.72|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.30|-0.72|<0.001
91541406|NCT00232180|182962738|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.154||||0.8539|TWO_SIDED|95.0|0.251|5.312||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||5.312|0.251|0.8539
91541407|NCT00232180|182962739|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.585||||0.0175|TWO_SIDED|95.0|0.376|0.91||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.910|0.376|0.0175
91541408|NCT00232180|182962740|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.885||||0.6009|TWO_SIDED|95.0|0.559|1.4||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.400|0.559|0.6009
91541409|NCT02748317|182962741|OTHER|1 group t-test no comparison group|||||=|0.219||||||P-value is not adjusted|t-test, 2 sided|||||||=0.219
91541410|NCT01424397|182962806|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with FP alone compared to Placebo using Mixed Models Analysis was 1.0000|||
91541411|NCT01424397|182962806|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 alone compared to Placebo using Mixed Models Analysis was 0.7127|||
91541412|NCT01424397|182962806|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to Placebo using Mixed Models Analysis was 1.0000|||
91541413|NCT01424397|182962806|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to FP alone using Mixed Models Analysis was 0.0160|||
91541414|NCT01424397|182962808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.35|STANDARD_ERROR_OF_MEAN|12.56|||TWO_SIDED|90.0|60.54|102.15||||||Placebo versus FP 200 μg,Nasal Airflow resistance Total WM,0-4 hr||102.15|60.54|
91763869|NCT00286429|183418369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.37|-0.80|<0.001
91541415|NCT01424397|182962808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.31|STANDARD_ERROR_OF_MEAN|19.548|||TWO_SIDED|90.0|-39.7|25.05||||||Placebo versus FP 12 mg SB-705498 , Nasal Airflow resistance Total WM, 0-4 hr||25.05|-39.7|
91541416|NCT01424397|182962808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.4|STANDARD_ERROR_OF_MEAN|14.567|||TWO_SIDED|90.0|48.28|96.52||||||Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||96.52|48.28|
91541417|NCT01424397|182962808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.95|STANDARD_ERROR_OF_MEAN|14.592|||TWO_SIDED|90.0|-33.1|15.22||||||FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||15.22|-33.1|
91541418|NCT01424397|182962809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.113|||TWO_SIDED|90.0|-0.87|-0.49||||||||-0.49|-0.87|
91541419|NCT01424397|182962809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.173|||TWO_SIDED|90.0|-0.3|0.27||||||||0.27|-0.30|
91541420|NCT01424397|182962809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.74|-0.31||||||||-0.31|-0.74|
91541421|NCT01424397|182962809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.06|0.37||||||||0.37|-0.06|
91541422|NCT01149369|182962817|NON_INFERIORITY_OR_EQUIVALENCE|P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.|Risk Ratio (RR)|1.2||||0.43|TWO_SIDED|95.0|0.8|1.7|||Cochran-Mantel-Haenszel|Stratified by clinic||Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \< 25 mm.||1.7|0.8|0.43
91541423|NCT01149369|182962818|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.5||||0.03|TWO_SIDED|95.0|-2.8|-0.1|||ANCOVA|||||-0.1|-2.8|0.03
91541424|NCT01149369|182962819|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.94|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.94
91541425|NCT01149369|182962820|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.73
91541426|NCT01149369|182962821|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
91541427|NCT01149369|182962822|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.06|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.06
91541428|NCT01149369|182962823|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.24|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.24
91763870|NCT00286429|183418370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001|TWO_SIDED|95.0|-0.34|-0.09||No multiplicity adjustments|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.09|-0.34|<0.001
91541429|NCT01149369|182962824|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.01
91541430|NCT01149369|182962825|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
91541431|NCT01149369|182962826|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.03||||0.51|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.51
91541432|NCT01149369|182962827|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.12|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.12
91541433|NCT01149369|182962828|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.02
91541434|NCT01149369|182962829|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.17|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||||0.7|-0.1|0.17
91541435|NCT01149369|182962830|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.6||||0.59|TWO_SIDED|95.0|-7.0|12.2|||ANCOVA|||||12.2|-7.0|0.59
91541436|NCT01149369|182962831|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.0|||ANCOVA|||||10.0|-5.9|0.61
91541437|NCT01149369|182962832|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.23|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.23
91541438|NCT01149369|182962833|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.97|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.97
91541439|NCT01149369|182962834|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|3.1||||0.77|TWO_SIDED|95.0|-18.0|24.2|||ANCOVA|||||24.2|-18.0|0.77
91541440|NCT01149369|182962835|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.46|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.46
91541441|NCT01149369|182962836|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||||0.4|-0.2|0.44
91541442|NCT01149369|182962837|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.77
91541443|NCT01149369|182962838|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.8|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.80
91541444|NCT01149369|182962839|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.88|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.88
91541445|NCT01149369|182962840|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-10.9||||0.17|TWO_SIDED|95.0|-26.5|4.7|||ANCOVA|||||4.7|-26.5|0.17
91541446|NCT01149369|182962841|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.07|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||0.0|-1.5|0.07
91541447|NCT01149369|182962842|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.53|TWO_SIDED|95.0|-0.7|1.3|||ANCOVA|||||1.3|-0.7|0.53
91541448|NCT01149369|182962843|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.93|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||||1.0|-0.9|0.93
91541449|NCT01149369|182962844|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.52|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.52
91541450|NCT01149369|182962845|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.76
91541451|NCT01149369|182962846|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.45|TWO_SIDED|95.0|-2.0|0.9|||ANCOVA|||||0.9|-2.0|0.45
91541452|NCT01149369|182962847|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.1|0.0|0.18
91541453|NCT01149369|182962848|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.008|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|||||-0|-0.2|0.008
91541454|NCT01149369|182962849|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||||-0.3|-0.9|0.001
91541455|NCT01149369|182962850|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
91541456|NCT01149369|182962851|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.13|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.13
91541457|NCT01149369|182962852|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
91541458|NCT01149369|182962853|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
91541459|NCT01149369|182962854|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.007|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.007
91541460|NCT01149369|182962855|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.005|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||||-0.2|-1.3|0.005
91541461|NCT01149369|182962856|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|0.001
91541462|NCT01149369|182962857|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.003|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||||-0.3|-2.3|0.003
91541463|NCT01149369|182962858|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.03|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.03
91541464|NCT01149369|182962859|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.16|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.16
91541465|NCT01149369|182962860|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.05
91541466|NCT01149369|182962861|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.72
91541467|NCT01149369|182962862|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.001|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.001
91541468|NCT01149369|182962863|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.04
91541469|NCT01149369|182962864|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.14
91541470|NCT01149369|182962865|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.07|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.07
91541471|NCT01149369|182962866|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.19|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||||0.2|-0.8|0.19
91541472|NCT01149369|182962867|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||-0.0|-0.9|0.04
91541473|NCT01149369|182962868|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.02
91541474|NCT01149369|182962869|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
91541475|NCT01149369|182962870|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.09|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.09
91541476|NCT01149369|182962871|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.17|TWO_SIDED|95.0|-7.0|0.1|||ANCOVA|||||0.1|-7|0.17
91541477|NCT01149369|182962872|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.009|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||||-0.2|-1.1|0.009
91541478|NCT01149369|182962873|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
91541479|NCT01149369|182962874|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.10
91541480|NCT01149369|182962875|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.13|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.13
91541481|NCT01149369|182962876|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||||0.4|-0.5|0.98
91541482|NCT01149369|182962877|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.007|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.007
91541483|NCT01149369|182962878|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
91541484|NCT01149369|182962879|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|||||-0.2|-1.0|0.001
91541485|NCT01149369|182962880|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.28
91541486|NCT01149369|182962881|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.05
91541487|NCT01149369|182962882|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
91541488|NCT01149369|182962883|SUPERIORITY|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.53|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|||||0.6|-1.1|0.53
91541489|NCT01149369|182962884|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.38|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||||0.5|-1.3|0.38
91541490|NCT01149369|182962885|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-2.2||||0.09|TWO_SIDED|95.0|-4.7|0.4|||ANCOVA|||||0.4|-4.7|0.09
91541491|NCT01149369|182962886|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.8||||0.28|TWO_SIDED|95.0|-5.2|1.5|||ANCOVA|||||1.5|-5.2|0.28
91541492|NCT01149369|182962887|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.6||||0.3|TWO_SIDED|95.0|-4.6|1.4|||ANCOVA|||||1.4|-4.6|0.30
91541493|NCT01149369|182962888|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-21.2||||0.4|TWO_SIDED|95.0|-70.5|28.1|||ANCOVA|||||28.1|-70.5|0.40
91541494|NCT01149369|182962889|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.2||||0.28|TWO_SIDED|95.0|-12.0|3.5|||ANCOVA|||||3.5|-12.0|0.28
91541495|NCT01149369|182962890|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.4||||0.47|TWO_SIDED|95.0|-4.1|8.9|||ANCOVA|||||8.9|-4.1|0.47
91541496|NCT01149369|182962891|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.2||||0.68|TWO_SIDED|95.0|-4.5|6.9|||ANCOVA|||||6.9|-4.5|0.68
91541497|NCT01149369|182962892|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.0||||0.48|TWO_SIDED|95.0|-3.6|7.6|||ANCOVA|||||7.6|-3.6|0.48
91541498|NCT01149369|182962893|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.5||||0.43|TWO_SIDED|95.0|-2.2|5.1|||ANCOVA|||||5.1|-2.2|0.43
91541499|NCT01149369|182962894|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.2|||ANCOVA|||||-1.2|-8.5|0.01
91541500|NCT01149369|182962895|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.1|||ANCOVA|||||6.1|-3.4|0.57
91541501|NCT01149369|182962896|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.84||||0.34|TWO_SIDED|95.0|-2.6|1.0|||ANCOVA|||||1.0|-2.6|0.34
91541502|NCT01951170|182962903|SUPERIORITY_OR_OTHER|||||||0.83||||||Change in mTSS scores from baseline to Week 24.|Wilcoxon signed rank test|||||||0.83
91541503|NCT03292913|182962979|SUPERIORITY||Risk Ratio (RR)|1.07||||0.22|TWO_SIDED|95.0|0.96|1.21|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.||Outcome measure for this analysis is viral load suppression. A priori threshold for statistical significance is p-value less than 0.05.||1.21|0.96|0.220
91541504|NCT03292913|182962980|SUPERIORITY||Risk Ratio (RR)|1.04||||0.481|TWO_SIDED|95.0|0.94|1.15|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is retention in care. A priori threshold for statistical significance is p-value less than 0.05.||1.15|0.94|0.481
91541505|NCT03292913|182962981|SUPERIORITY||Risk Ratio (RR)|0.86||||0.093|TWO_SIDED|95.0|0.72|1.03|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is a 6-month visit gap defined ashaving at least 189 days between two sequentially kept visits, post-randomization. A priori threshold for statistical significance is p-value less than 0.05.||1.03|0.72|0.093
91541506|NCT03950622|182962982|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-2.4||||0.175|TWO_SIDED|95.0|-5.8|1.1|||Miettinen & Nurminen|||Injection site redness/erythema||1.1|-5.8|0.175
91541507|NCT03950622|182962982|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|11.7|||<|0.001|TWO_SIDED|95.0|6.0|17.2|||Miettinen & Nurminen|||Injection site tenderness/pain||17.2|6.0|<0.001
91541508|NCT03950622|182962982|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.3||||0.488|TWO_SIDED|95.0|-2.4|5.0|||Miettinen & Nurminen|||Injection site swelling||5.0|-2.4|0.488
91541509|NCT03950622|182962983|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2||||0.888|TWO_SIDED|95.0|-2.8|2.4|||Miettinen & Nurminen|||Joint pain/arthralgia||2.4|-2.8|0.888
91541510|NCT03950622|182962983|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.96|TWO_SIDED|95.0|-4.2|4.4|||Miettinen & Nurminen|||Tiredness/fatigue||4.4|-4.2|0.960
91541511|NCT03950622|182962983|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.4||||0.469|TWO_SIDED|95.0|-5.1|2.4|||Miettinen & Nurminen|||Headache||2.4|-5.1|0.469
91541512|NCT03950622|182962983|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.4||||0.082|TWO_SIDED|95.0|-0.4|7.4|||Miettinen & Nurminen|||Muscle pain/myalgia||7.4|-0.4|0.082
91541513|NCT03950622|182962984|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||Miettinen & Nurminen|||Vaccine-related SAEs||0.6|-0.6|
91541514|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96|||Constrained longitudinal data analysis|GMT ratio, 95% CI, and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||Serotype 1 (Shared)||0.96|0.66|<0.001
91541515|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
91541516|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.57|0.8|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 4 (Shared)||0.80|0.57|<0.001
91541517|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 5 (Shared)||0.98|0.64|<0.001
91541518|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6A (Shared)||1.19|0.84|<0.001
91541519|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.02|1.48|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6B (Shared)||1.48|1.02|<0.001
91541520|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.9|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 7F (Shared)||0.90|0.68|<0.001
91541521|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.7|0.94|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 9V (Shared)||0.94|0.70|<0.001
91541522|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 14 (Shared)||0.89|0.64|<0.001
91541523|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.91|1.26|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 18C (Shared)||1.26|0.91|<0.001
91541524|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.7|0.93|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19A (Shared)||0.93|0.70|<0.001
91541525|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.76|1.02|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19F (Shared)||1.02|0.76|<0.001
91541526|NCT03950622|182962985|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.96|1.44|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 23F (Shared)||1.44|0.96|<0.001
91541527|NCT03950622|182962985|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|31.83|||<|0.001|TWO_SIDED|95.0|25.35|39.97|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 22F (Unique to V114)||39.97|25.35|<0.001
91541528|NCT03950622|182962985|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|7.11|||<|0.001|TWO_SIDED|95.0|6.07|8.32|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 33F (Unique to V114)||8.32|6.07|<0.001
91541529|NCT03950622|182962986|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1.|Percentage Point Difference|57.1|||<|0.001|TWO_SIDED|95.0|52.0|61.8|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 22F (Unique to V114)||61.8|52.0|<0.001
91541530|NCT03950622|182962986|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1)|Percentage Point Difference|50.5|||<|0.001|TWO_SIDED|95.0|45.9|54.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 33F (Unique to V114)||54.9|45.9|<0.001
91541531|NCT03950622|182962987|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 1.2.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
91541532|NCT03950622|182962988|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the difference(V114 - Prevnar 13™) between the proportions of participants with a ≥4-fold rise from prevaccination (Day 1) to 30 days postvaccination (Day 30) to be greater than 0.|Percentage Point Difference|11.5|||<|0.001|TWO_SIDED|95.0|6.0|16.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 3 (Shared) ≥4-Fold Rise in OPA||16.9|6.0|<0.001
91541533|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 1 (Shared)||0.83|0.62|
91541534|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.33|1.71||||||Serotype 3 (Shared)||1.71|1.33|
91541535|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 4 (Shared)||0.83|0.62|
91541536|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96||||||Serotype 5 (Shared)||0.96|0.70|
91541537|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 6A (Shared)||1.21|0.87|
91541538|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 6B (Shared)||1.64|1.17|
91541539|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89||||||Serotype 7F (Shared)||0.89|0.66|
91541540|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0||||||Serotype 9V (Shared)||1.00|0.75|
91541541|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 14 (Shared)||0.89|0.65|
91541542|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||Serotype 18C (Shared)||1.05|0.77|
91541543|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 19A (Shared)||0.97|0.73|
91541544|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.05||||||Serotype 19F (Shared)||1.05|0.78|
91541545|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 23F (Shared)||1.28|0.92|
91541546|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.62|||||TWO_SIDED|95.0|9.37|12.03||||||Serotype 22F (Unique to V114)||12.03|9.37|
91541547|NCT03950622|182962989|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.98|||||TWO_SIDED|95.0|8.0|10.07||||||Serotype 33F (Unique to V114)||10.07|8.00|
91541548|NCT01546753|182963023|SUPERIORITY|The change from baseline OFC to week 38 OFC (primary outcome measure) was compared between the two groups using a Mann-Whitney U test.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91541549|NCT01546753|182963024|SUPERIORITY|Differences in dichotomous outcomes for the percentage of participants who reach the 5000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test||||||0.01|||||||Fisher Exact|||||||0.01
91541550|NCT01546753|182963025|SUPERIORITY|Differences in dichotomous outcomes including the percentage of subjects who reach the 2000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
91541551|NCT01546753|182963026|SUPERIORITY|Differences in dichotomous outcomes such as the percentage of subjects who reach the 2000 mg cumulative dose to the tree nut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
91541552|NCT01546753|182963028|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91541553|NCT01102231|182963038|OTHER||Proportion difference|0.905|||||TWO_SIDED|95.0|0.846|0.964||||||||0.964|0.846|
91541554|NCT01195883|182963048|SUPERIORITY||Risk Ratio (RR)|0.9||||0.51|TWO_SIDED|95.0|0.65|1.23|||GEE model|||||1.23|0.65|0.51
91541555|NCT01195883|182963049|SUPERIORITY||Risk Ratio (RR)|0.95||||0.42|TWO_SIDED|95.0|0.81|1.11|||Chi-squared|||||1.11|0.81|0.42
91541556|NCT01195883|182963050|SUPERIORITY||Risk Ratio (RR)|0.89||||0.26|TWO_SIDED|95.0|0.72|1.09|||Chi-squared|||||1.09|0.72|0.26
91541557|NCT01195883|182963051|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4|TWO_SIDED|95.0|0.69|2.58|||Chi-squared|||||2.58|0.69|0.40
91541558|NCT04470375|182963073|OTHER|Paired samples pre-post t-test||||||0.137|||||||t-test, 2 sided|||||||.137
91541559|NCT04470375|182963074|OTHER|Paired samples t-test (pre - post measure of group)||||||0.01|||||||t-test, 2 sided|||||||.010
91541560|NCT04470375|182963075|OTHER|Paired samples t-test (pre post measure of group)||||||0.591|||||||t-test, 2 sided|||||||.591
91541561|NCT05714696|182963076|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
91541562|NCT05714696|182963077|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||.049
91541563|NCT05714696|182963078|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||.029
91541564|NCT05714696|182963079|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
91541565|NCT05714696|182963080|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||.442
91541566|NCT05714696|182963082|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||||||.527
91541567|NCT05714696|182963083|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||.311
91541568|NCT05714696|182963084|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
91541569|NCT05714696|182963085|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||.005
91763871|NCT00286429|183418370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.20|-0.45|<0.001
91763872|NCT00286429|183418371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.31||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.31|-0.65|<0.001
91541570|NCT04090190|182963099|SUPERIORITY|||||||0.6497|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the CRP Calc. Conc. (pg/ml) between baseline and follow-up.||||0.6497
91541571|NCT04090190|182963099|SUPERIORITY|||||||0.4281|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the IL-12/IL-23p40 Calc. Conc. (pg/ml) between baseline and follow-up.||||0.4281
91541572|NCT04090190|182963099|SUPERIORITY|||||||0.3157|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of MCP-1 Calc. Conc. (pg/ml) is due to chance.||||0.3157
91541573|NCT04090190|182963099|SUPERIORITY|||||||0.1463|||||||Wilcoxon (Mann-Whitney)|||This p-value represents the probability that the difference between baseline and follow-up levels of GM-CSF Calc. Conc. (pg/ml) is due to chance.||||0.1463
91541574|NCT04090190|182963099|SUPERIORITY|||||||0.6091|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-1β Calc. Conc. (pg/ml) is due to chance.||||0.6091
91541575|NCT04090190|182963099|SUPERIORITY|||||||0.3011|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-6 Calc. Conc. (pg/ml) is due to chance.||||0.3011
91541576|NCT04090190|182963099|SUPERIORITY|||||||0.5009|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-8 Calc. Conc. (pg/ml) is due to chance.||||0.5009
91541577|NCT00940537|182963103|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||a priori threshhold for significance was set at p\<0.05.|t-test, 2 sided|this was a paired t-test||As there was no a priori reason for the level of IHTG to impact this measurement we compared the pre and post-prandial results for all subjects whose data were of sufficient quality (N=12). These results are comparing the two categories of fasting and post-prandial. Null hypothesis was that there would be no difference in IHTG before and after a high fat, high carbohydrate meal.||||.097
91541578|NCT00940537|182963104|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This p-value compares the low IHTG (\<5%) subjects to those with medium levels of IHTG (5 - 10%). The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intrahepatic triglyceride (IHTG) and would be equal for the low and medium IHTG categories.||||0.006
91541579|NCT00940537|182963104|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (\<5%) and high (\>10%) IHTG categories.||||<0.0001
91541580|NCT00940537|182963104|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||The a priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (\<10%) IHTG groups would not be statistically different with regard to average T2 ratio.||||.93
91541581|NCT01212991|182963107|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.706|||<|0.0001|TWO_SIDED|95.0|0.596|0.837||A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.|||0.837|0.596|<0.0001
91541582|NCT01212991|182963108|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.186|||<|0.0001|TWO_SIDED|95.0|0.149|0.231||The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.231|0.149|<0.0001
91541583|NCT01212991|182963109|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.718|||<|0.0001||95.0|0.61|0.844||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.844|0.610|<0.0001
91541584|NCT01212991|182963110|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.349|||<|0.0001||95.0|0.303|0.403||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.403|0.303|<0.0001
91541585|NCT01212991|182963111|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.169|||<|0.0001||95.0|0.147|0.195||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0167 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.195|0.147|<0.0001
91541586|NCT01212991|182963112|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rates|74.51|||<|0.0001||95.0|71.45|77.57||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.025 for this analysis.|Cochran-Mantel-Haenszel|||||77.57|71.45|<0.0001
91541587|NCT01212991|182963113|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|53.85|||<|0.0001||95.0|48.53|59.17||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.|Cochran-Mantel-Haenszel|||||59.17|48.53|<0.0001
91541588|NCT03122886|182963117|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.9|TWO_SIDED|95.0|0.12|6.37|||Log Rank|||||6.37|0.12|0.90
91541589|NCT01285999|182963141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.05|TWO_SIDED|95.0|-0.37|-0.21||p-value has not been adjusted.|t-test, 2 sided|No adjustment.||H0: μt - μc = 0 H1: μt - μc ≠ 0 where μt and μc are the mean 9-month in-stent late loss values for the subjects in the PROMUS Element test and TAXUS Liberté control treatment groups, respectively.||-0.21|-0.37|0.05
91541590|NCT01693120|182963185|SUPERIORITY||rate|1.6||||0.175|ONE_SIDED|95.0||4.9|||exact binomial test|||The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05||4.9||0.175
91541591|NCT01693120|182963186|OTHER|The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.|rate|52.6|||||TWO_SIDED|95.0|43.1|62.1||||||||62.1|43.1|
91541592|NCT01693120|182963187|OTHER|There was no prespecified hypothesis tested.|rate|90.7|||||TWO_SIDED|95.0|84.3|95.1||||||There was no prespecified hypothesis tested.||95.1|84.3|
91541593|NCT01693120|182963188|OTHER|There was no pre-specified hypothesis to test|rate|0.0|||||TWO_SIDED|95.0|0.0|6.1||||||There was no pre-specified hypothesis to test||6.1|0|
91541594|NCT02597920|182963210|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 2.||||<0.0001
91541595|NCT02597920|182963210|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 3.||||<0.0001
91541596|NCT02597920|182963210|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 2.||||<0.0001
91541597|NCT02597920|182963210|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 3.||||<0.0001
91763873|NCT00286429|183418371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.39|-0.73|<0.001
91541598|NCT02597920|182963211|OTHER|||||||0.0005|||||||Propensity score matching method|||Between group comparison of Visit 2 CDS||||0.0005
91541599|NCT02597920|182963211|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 3 CDS||||0.0002
91541600|NCT02597920|182963211|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 2 SDS||||0.0002
91541601|NCT02597920|182963211|OTHER|||||||0.0004|||||||Propensity score matching method|||Between group comparison of Visit 3 SDS||||0.0004
91541602|NCT02597920|182963216|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 CDS with that of Visit 3.||||<0.0001
91541603|NCT02597920|182963216|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 SDS with that of Visit 3.||||<0.0001
91541604|NCT01911169|182963234|OTHER||Cohen's d|0.68|||||TWO_SIDED|||||||||Effect size of primary outcome was calculated||||
91541605|NCT01911169|182963234|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||This study was conducted to determine the effect size for in change in FMD at 16 weeks with 25(OH) therapy. For change in FMD at 16 weeks with 25(OH)D repletion, based on this effect size, to detect significant differences between 2 groups, assuming 1) normally distributed data, 2) the same effect size, 3) alpha= 0.05, and 4) a power of 0.8, 35 patients in each group would be required. Therefore, this was designed as a pilot to determine effect size.||||> 0.05
91763874|NCT00286429|183418372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.77|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.77|<0.001
91541606|NCT02384070|182963236|SUPERIORITY_OR_OTHER|||||||1||||||Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.|ANOVA|||||||1
91541607|NCT02384070|182963236|SUPERIORITY_OR_OTHER|||||||1||||||The prior threshold for statistical significance was P \< 0.05|ANOVA|||||||1
91541608|NCT00546754|182963251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||ANOVA|||||||0.153
91541609|NCT00546754|182963252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0|||||ANOVA|||||||0.343
91541610|NCT00546754|182963253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
91541611|NCT00546754|182963254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395||95.0|||||ANOVA|||||||0.395
91541612|NCT00546754|182963255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.662||95.0|||||Fisher Exact|||||||0.662
91541613|NCT00546754|182963256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Log Rank|||||||0.020
91541614|NCT00546754|182963257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91541615|NCT00546754|182963258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||ANOVA|||||||0.935
91541616|NCT00546754|182963259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
91541617|NCT00546754|182963260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||95.0|||||ANOVA|||||||0.899
91541618|NCT00546754|182963261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||ANOVA|||||||0.218
91541619|NCT00546754|182963262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0|||||ANOVA|||||||0.386
91541620|NCT00546754|182963263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725||95.0|||||ANOVA|||||||0.725
91541621|NCT05061693|182963295|SUPERIORITY||Odds Ratio (OR)|7.1||||0.0061|TWO_SIDED|95.0|1.6|45.4|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||45.4|1.6|0.0061
91541622|NCT05061693|182963295|SUPERIORITY||difference in response rate|28.0|STANDARD_ERROR_OF_MEAN|9.18|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
91541623|NCT05061693|182963295|SUPERIORITY||Odds Ratio (OR)|10.2||||0.0005|TWO_SIDED|95.0|2.3|65.6|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||65.6|2.3|0.0005
91541624|NCT05061693|182963295|SUPERIORITY||difference in response rate|36.3|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
91541625|NCT05061693|182963295|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|3.9|107.5|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||107.5|3.9|<0.0001
91541626|NCT05061693|182963295|SUPERIORITY||difference in response rate|48.6|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
91541627|NCT00396084|182963304|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 4 treatment groups over the 7 days of study drug administration||||<0.001
91541628|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.041
91541629|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.008
91541630|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.012
91541631|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.01
91541632|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.03
91541633|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.091
91541634|NCT00396084|182963304|SUPERIORITY_OR_OTHER|||||||0.354||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.354
91541635|NCT00396084|182963308|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 4 treatment groups were compared.||||0.05
91541636|NCT00396084|182963308|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against gatifloxacin using a simultaneous non-parametric procedure.||||0.01
91541637|NCT00396084|182963308|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against moxifloxacin using a simultaneous non-parametric procedure.||||0.02
91541638|NCT00396084|182963308|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against levofloxacin using a simultaneous non-parametric procedure.||||0.14
91541639|NCT00396084|182963309|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Mean values of EBA Days 2 to 7 for the 4 treatment groups were compared.||||0.51
91541640|NCT00396084|182963309|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||The rate of fall in sputum cfu for the 4 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.16
91541641|NCT00396084|182963309|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for patients in the 3 fluoroquinolone groups were pooled and compared to bactericidal activity of patients in the INH arm.||||0.036
91541642|NCT00396084|182963310|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 3 treatment groups over the 7 days of study drug administration||||<0.001
91541643|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.023
91541644|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.018
91541645|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.03
91541646|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.012
91541647|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
91541648|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
91541649|NCT00396084|182963310|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.004
91541650|NCT00396084|182963311|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 3 treatments groups were compared.||||<0.01
91541651|NCT00396084|182963311|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against Linezolid once daily using a simultaneous non-parametric procedure.||||<0.01
91541652|NCT00396084|182963311|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Mean EBA 0-2 of INH was compared to pooled Linezolid once daily and Linezolid twice daily results.||||<0.01
91541653|NCT00396084|182963314|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Mean values EBA Days 2-7 for the 3 treatment groups were compared.||||0.25
91541654|NCT00396084|182963314|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||The rate of fall in sputum cfu for the 3 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.42
91541655|NCT00396084|182963314|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for INH was compared to that of the pooled linezolid arms.||||0.14
91541656|NCT00311363|182963330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.353||||0.0158||95.0|0.2|0.8||Model included terms for treatment group, randomization IRLS score (Week 24), and pooled study site|Regression, Logistic|||||0.8|0.2|0.0158
91763875|NCT00286429|183418372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.34|-0.75|<0.001
91541657|NCT00696618|182963394|SUPERIORITY_OR_OTHER||||||<|0.05||||||Adjusted for multiple comparisons.|multi-level|||Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.||||<.05
91541658|NCT00696618|182963395|SUPERIORITY_OR_OTHER||||||<|0.05|||||||multi-level|||||||<.05
91541659|NCT00696618|182963396|SUPERIORITY_OR_OTHER||||||<|0.05|||||||mulit-level analysis|||||||<.05
91541660|NCT00028093|182963397|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in the outcome between the two groups||||0.54
91541661|NCT03473340|182963409|SUPERIORITY|||||||0.17697507|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.17697507
91541662|NCT03473340|182963410|SUPERIORITY|||||||0.77367872|||||||Welch Two Sample t-test|||P-Value provided is for net change only.||||0.77367872
91541663|NCT03473340|182963411|SUPERIORITY|||||||0.68595748|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.68595748
91541664|NCT03473340|182963412|SUPERIORITY|||||||0.00127634|||||||Fisher Exact|||||||0.00127634
91541665|NCT03473340|182963413|SUPERIORITY|||||||0.80904544|||||||Fisher Exact|||||||0.80904544
91541666|NCT02079844|182963414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.232|STANDARD_ERROR_OF_MEAN|0.7313||0.753|TWO_SIDED|95.0|-1.269|1.733||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.733|-1.269|0.753
91541667|NCT02079844|182963414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.133|STANDARD_ERROR_OF_MEAN|0.7417||0.859|TWO_SIDED|95.0|-1.389|1.655||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.655|-1.389|0.859
91541668|NCT02079844|182963415|SUPERIORITY_OR_OTHER||LS Mean Difference|1.938|STANDARD_ERROR_OF_MEAN|1.2436||0.131|TWO_SIDED|95.0|-0.614|4.49||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.490|-0.614|0.131
91541669|NCT02079844|182963415|SUPERIORITY_OR_OTHER||LS Mean Difference|2.377|STANDARD_ERROR_OF_MEAN|1.2545||0.069|TWO_SIDED|95.0|-0.198|4.951||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.951|-0.198|0.069
91541670|NCT02079844|182963416|SUPERIORITY_OR_OTHER||LS Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.1757||0.671|TWO_SIDED|95.0|-0.739|0.106||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.106|-0.739|0.671
91541671|NCT02079844|182963416|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.171|STANDARD_ERROR_OF_MEAN|0.1757||0.345|TWO_SIDED|95.0|-1.193|0.571||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.571|-1.193|0.345
91541672|NCT01420549|182963431|NON_INFERIORITY|The non-inferiority assessment was analyzed by the bilateral confidence interval (95%) for the ratio of the mean LDLfinal/LDLbaseline of the R/E combination, compared to the mean LDLfinal/LDLbaseline of the S/E combination and the bilateral confidence interval (95%) for the difference between the two means of the percentage variation of LDL-C in the treatments (\[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)R+E\] - \[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)S+E\].|Median Difference (Final Values)|-10.32|STANDARD_ERROR_OF_MEAN|3.33||0.0013|TWO_SIDED|95.0|-16.94|-3.7|||ANCOVA|Estimates for treatment effect and their 95% confidence intervals were exponentiated to produce estimates of percentage change.|Mean Percentage Change LDL- C (%)|Rosuvastatin + Ezetimibe versus Simvastatin + Ezetimibe||-3.70|-16.94|0.0013
91541673|NCT03394885|182963432|OTHER||Exact Binomial Confidence Interval|83.0|||||TWO_SIDED|95.0|66.0|100.0||||||||100|66|
91541674|NCT03949335|182963454|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91541675|NCT03949335|182963455|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91541676|NCT03949335|182963456|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91541677|NCT03949335|182963457|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.031|||||TWO_SIDED|95.0|-0.053|-0.01||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||-0.010|-0.053|
91541678|NCT03949335|182963459|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91541679|NCT01351272|182963460|SUPERIORITY||||||=|0.09|||||||SPM two-sample t-test|||||||=0.09
91541680|NCT01351272|182963461|SUPERIORITY||||||=|0.16|||||||t-test, 1 sided|||||||= 0.16
91541681|NCT01351272|182963462|SUPERIORITY||||||=|0.09|||||||t-test, 1 sided|||||||= 0.09
91541682|NCT00801983|182963505|SUPERIORITY_OR_OTHER||||||>|0.05|||||||GEE|||Subjects were compared across keyboard types - The percentage of subjects with MSD when using the alternative keyboard were compared to the % of subjects with MSD when they were using the typical keyboard||||>.05
91763876|NCT00286429|183418373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.79|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.79|<0.001
91541683|NCT03149991|182963508|SUPERIORITY|The unstructured covariance matrix structure was used to model nesting of observations within persons. Non-significant site interaction effects were removed one at a time. Least squares means estimates of the linear fixed effects model on SDQ change scores, adjusting for baseline covariates was used to test the primary hypothesis via contrast statements.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.46|TWO_SIDED||||||Mixed Models Analysis|Because sample sizes per site varied substantially, we used the Kenward-Roger degrees of freedom method.|degrees of freedom = 44.5; t=-0.74|SDQ total was primary outcome \& Day 14 primary endpoint. Change from baseline was calculated for each person at each follow-up. Change score was the dependent variable in a linear fixed effects model, where a (-)number = less severe depression. For group comparison, treatment was coded as 1 \& placebo as 0, thus a (-)value means treatment doing better. Fixed effects: group(brex v placebo), day(1-28), site(6 sites). All 2-\& 3-way interactions were included, as well as a priori defined covariates.||||0.46
91541684|NCT03149991|182963508|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom = 41.3; t=2.07.|Secondary Aim: To evaluate the short-term effect of brexpiprazole, as measured by the Symptoms of Depression Questionnaire (SDQ), on Day 2. We used the same model as in Aim 1 to test this hypothesis.||||0.04
91541685|NCT03149991|182963508|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.92|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom=38.2; t=0.10.|To evaluate the long-term effect of brexpiprazole as measured by the Symptoms of Depression Questionnaire (SDQ) on Day 28. The same model as was used in Aim 1 was used to test this hypothesis.||||0.92
91541686|NCT03149991|182963509|SUPERIORITY||Chi-squared test|0.51||||0.47|TWO_SIDED|||||This p-value was not adjusted, however there were adjustments when using a logistic regression in Statistical Analysis #2.|Chi-squared|||We used a Chi-squared test to assess differences between treatment and control in terms of percent of participants achieving a long-term sustained response, as measured by achieving a 50% or greater reduction on the MADRS on Day 28.||||0.47
91541687|NCT03149991|182963509|SUPERIORITY||Odds Ratio (OR)|1.83||||0.35|TWO_SIDED|95.0|0.52|6.44|||Regression, Logistic|Adjusted for a priori defined covariates also included in Aim 1.||Logistic regression was used to assess a difference in 50% reduction on the MADRS on Day 28 between groups.||6.44|0.52|0.35
91541688|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|1.59||0.04|TWO_SIDED|||||Because tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 41.0, t=2.13.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 2.||||0.04
91541689|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|2.94||0.73|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.35|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 14.||||0.73
91541690|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|3.16||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.8, t=-0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 28.||||0.37
91541691|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|0.85||0.06|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 40.3, t=1.94.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 2.||||0.06
91541692|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.06||0.83|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.22|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 14.||||0.83
91541693|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.2||0.52|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.0, t=-0.64|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 28.||||0.52
91541694|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.19||0.11|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 31.0, t=1.67|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 2.||||0.11
91541695|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.98|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=41.1, t=-0.03|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 14.||||0.98
91541696|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=46.0, t=-0.76|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 28.||||0.45
91541697|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=49.2, t=2.39;|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 2.||||0.02
91541698|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=56.8, t=1.85|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 14.||||0.07
91541699|NCT03149991|182963510|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.41||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=50.5, t=0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 28.||||0.37
91541700|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in terms of occurrence of abnormal ECGs.|Chi-squared test|0.28||||0.6|TWO_SIDED||||||Chi-squared|||This analysis was to assess group differences (drug vs. placebo) in terms of number of abnormal ECGs out of total ECGs assessed.||||0.60
91541701|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at baseline.|Chi-squared test|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at baseline.||||0.33
91541702|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 4.|Chi-squared test|0.0||||1|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 4.||||1.00
91763877|NCT00286429|183418373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.33||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.33|-0.75|<0.001
91763878|NCT00286429|183418374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.80|<0.001
91763879|NCT00286429|183418374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.79|-0.35||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.35|-0.79|<0.001
91541703|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 5.|Chi-squared test|0.08||||0.78|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 5.||||0.78
91541704|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 6.|Chi-squared test|0.02||||0.9|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 6.||||0.90
91541705|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 7.|Chi-squared test|0.63||||0.43|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 7.||||0.43
91541706|NCT03149991|182963514|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 9.|Chi-squared test|0.09||||0.76|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 9.||||0.76
91541707|NCT03149991|182963516|EQUIVALENCE|The hypothesis was that there would be no group differences in number of participants reporting adverse events.|Chi-squared test|0.009||||0.92|TWO_SIDED||||||Chi-squared|||This analysis assessed group differences (drug vs. placebo) in terms of number of participants reporting adverse events.||||0.92
91541708|NCT03149991|182963517|EQUIVALENCE|The hypothesis was that there would be no difference between the groups in terms of mean number of adverse events per person, among those who reported any adverse events.|Mean Difference (Final Values)|0.24||||0.81|TWO_SIDED||||||t-test, 2 sided|||This analysis assessed group differences (drug vs. placebo) in terms of mean number of adverse events per person, among those who reported any adverse events.||||0.81
91763880|NCT00286429|183418375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3||||0.128|TWO_SIDED|95.0|-25.9|3.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||3.3|-25.9|0.128
91541709|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared test|0.43||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) throughout the trial.||||0.51
91541710|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|2.85||||0.09|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Screening.||||0.09
91541711|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.004||||0.95|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Baseline.||||0.95
91541712|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.005||||0.94|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 1.||||0.94
91541713|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|1.97||||0.16|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 2.||||0.16
91541714|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.44||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 5.||||0.51
91541715|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 8.||||0.33
91541716|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.003||||0.96|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 11.||||0.96
91541717|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.5||||0.48|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 14.||||0.48
91541718|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 17.||||0.41
91541719|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.17||||0.68|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 21.||||0.68
91541720|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 23.||||0.41
91541721|NCT03149991|182963518|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 28.||||0.41
91541722|NCT04714320|182963552|SUPERIORITY||||||=|0.135||||||The stratification factor (screening estimated glomerular filtration rate (eGFR) status \[\<60 vs. ≥60 mL/min/1.73 m\^2\]), treatment received, and baseline measure were included in the analysis of covariate (ANCOVA) model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.135
91541723|NCT04714320|182963552|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.867
91541724|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
91541725|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
91541726|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
91541727|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
91541728|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
91541729|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
91541730|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
91541731|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
91541732|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
91763881|NCT00286429|183418375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1||||0.034|TWO_SIDED|95.0|-31.1|-1.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.2|-31.1|0.034
91763882|NCT00286429|183418376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.563|TWO_SIDED|95.0|-17.9|9.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||9.7|-17.9|0.563
91763883|NCT00286429|183418376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4||||0.084|TWO_SIDED|95.0|-26.4|1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||1.7|-26.4|0.084
91541733|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
91541734|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
91763884|NCT00286429|183418377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3||||0.16|TWO_SIDED|95.0|-24.7|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-24.7|0.160
91541735|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
91541736|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
91541737|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
91541738|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
91541739|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
91541740|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
91541741|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
91541742|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||<0.001
91763885|NCT00286429|183418377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.02|TWO_SIDED|95.0|-32.1|-2.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-2.8|-32.1|0.020
91763886|NCT00286429|183418378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9||||0.013|TWO_SIDED|95.0|-33.7|-4.0||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.0|-33.7|0.013
91541743|NCT04714320|182963554|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||=0.002
91541744|NCT04714320|182963554|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||<0.001
91541745|NCT04714320|182963554|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||=0.002
91541746|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
91541747|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
91541748|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
91541749|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
91541750|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
91541751|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
91541752|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
91541753|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
91541754|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
91541755|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
91541756|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
91541757|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
91541758|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
91541759|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
91541760|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
91763887|NCT00286429|183418378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5||||0.011|TWO_SIDED|95.0|-34.5|-4.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.5|-34.5|0.011
91541761|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
91541762|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
91541763|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
91541764|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||<0.001
91541765|NCT04714320|182963555|SUPERIORITY||||||=|0.005||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||=0.005
91541766|NCT04714320|182963555|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||<0.001
91541767|NCT04714320|182963555|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||=0.002
91541768|NCT04714320|182963556|SUPERIORITY||||||=|0.094||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.094
91541769|NCT04714320|182963556|SUPERIORITY||||||=|0.842||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.842
91541770|NCT04714320|182963556|SUPERIORITY||||||=|0.066||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.066
91541771|NCT04714320|182963556|SUPERIORITY||||||=|0.442||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.442
91541772|NCT04714320|182963557|SUPERIORITY||||||=|0.834||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.834
91541773|NCT04714320|182963557|SUPERIORITY||||||=|0.945||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.945
91541774|NCT04714320|182963557|SUPERIORITY||||||=|0.208||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.208
91541775|NCT04714320|182963557|SUPERIORITY||||||=|0.74||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.740
91541776|NCT04714320|182963557|SUPERIORITY||||||=|0.019||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.019
91541777|NCT04714320|182963557|SUPERIORITY||||||=|0.56||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.560
91541778|NCT04714320|182963557|SUPERIORITY||||||=|0.903||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.903
91541779|NCT04714320|182963557|SUPERIORITY||||||=|0.268||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.268
91541780|NCT04714320|182963557|SUPERIORITY||||||=|0.702||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.702
91541781|NCT04714320|182963557|SUPERIORITY||||||=|0.885||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.885
91541782|NCT04714320|182963557|SUPERIORITY||||||=|0.066||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.066
91541783|NCT04714320|182963557|SUPERIORITY||||||=|0.783||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.783
91541784|NCT04714320|182963557|SUPERIORITY||||||=|0.456||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.456
91541785|NCT04714320|182963557|SUPERIORITY||||||=|0.102||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.102
91541786|NCT04714320|182963557|SUPERIORITY||||||=|0.668||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.668
91541787|NCT04714320|182963557|SUPERIORITY||||||=|0.454||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.454
91541788|NCT04714320|182963557|SUPERIORITY||||||=|0.044||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.044
91541789|NCT04714320|182963557|SUPERIORITY||||||=|0.704||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.704
91541790|NCT04714320|182963557|SUPERIORITY||||||=|0.878||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.878
91541791|NCT04714320|182963557|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.681
91541792|NCT04714320|182963557|SUPERIORITY||||||=|0.199||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.199
91541793|NCT04714320|182963557|SUPERIORITY||||||=|0.602||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.602
91541794|NCT04714320|182963557|SUPERIORITY||||||=|0.135||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.135
91541795|NCT04714320|182963557|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.407
91541796|NCT04714320|182963557|SUPERIORITY||||||=|0.795||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.795
91541797|NCT04714320|182963557|SUPERIORITY||||||=|0.036||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.036
91541798|NCT04714320|182963557|SUPERIORITY||||||=|0.915||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.915
91541799|NCT04714320|182963557|SUPERIORITY||||||=|0.957||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.957
91541800|NCT04714320|182963557|SUPERIORITY||||||=|0.804||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.804
91541801|NCT04714320|182963557|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.775
91541802|NCT04714320|182963557|SUPERIORITY||||||=|0.801||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.801
91541803|NCT04714320|182963557|SUPERIORITY||||||=|0.329||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.329
91541804|NCT04714320|182963557|SUPERIORITY||||||=|0.882||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.882
91541805|NCT04714320|182963557|SUPERIORITY||||||=|0.235||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.235
91541806|NCT04714320|182963557|SUPERIORITY||||||=|0.505||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.505
91541807|NCT04714320|182963557|SUPERIORITY||||||=|0.436||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.436
91541808|NCT04714320|182963557|SUPERIORITY||||||=|0.637||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.637
91541809|NCT04714320|182963557|SUPERIORITY||||||=|0.254||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.254
91541810|NCT04714320|182963557|SUPERIORITY||||||=|0.848||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.848
91541811|NCT04714320|182963557|SUPERIORITY||||||=|0.24||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.240
91541812|NCT04714320|182963557|SUPERIORITY||||||=|0.382||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.382
91541813|NCT04714320|182963557|SUPERIORITY||||||=|0.935||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.935
91541814|NCT04714320|182963557|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.278
91541815|NCT04714320|182963557|SUPERIORITY||||||=|0.211||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.211
91763888|NCT00286429|183418379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.624|TWO_SIDED|95.0|-18.9|11.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||11.3|-18.9|0.624
91541816|NCT04714320|182963557|SUPERIORITY||||||=|0.562||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.562
91541817|NCT04714320|182963557|SUPERIORITY||||||=|0.25||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.250
91763889|NCT00286429|183418379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.853|TWO_SIDED|95.0|-16.7|13.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||13.8|-16.7|0.853
91541818|NCT04714320|182963557|SUPERIORITY||||||=|0.114||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.114
91541819|NCT04714320|182963557|SUPERIORITY||||||=|0.55||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.550
91541820|NCT04714320|182963557|SUPERIORITY||||||=|0.423||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.423
91541821|NCT04714320|182963557|SUPERIORITY||||||=|0.422||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.422
91541822|NCT04714320|182963557|SUPERIORITY||||||=|0.073||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.073
91541823|NCT04714320|182963557|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.278
91541824|NCT04714320|182963557|SUPERIORITY||||||=|0.338||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.338
91541825|NCT04714320|182963557|SUPERIORITY||||||=|0.969||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.969
91541826|NCT04714320|182963557|SUPERIORITY||||||=|0.489||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.489
91541827|NCT04714320|182963557|SUPERIORITY||||||=|0.156||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.156
91541828|NCT04714320|182963557|SUPERIORITY||||||=|0.389||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.389
91541829|NCT04714320|182963557|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.775
91541830|NCT04714320|182963557|SUPERIORITY||||||=|0.437||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.437
91541831|NCT04714320|182963557|SUPERIORITY||||||=|0.618|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.618
91541832|NCT04714320|182963557|SUPERIORITY||||||=|0.079||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.079
91541833|NCT04714320|182963557|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.349
91541834|NCT04714320|182963557|SUPERIORITY||||||=|0.58||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.580
91541835|NCT04714320|182963557|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.106
91541836|NCT04714320|182963557|SUPERIORITY||||||=|0.955||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.955
91541837|NCT04714320|182963557|SUPERIORITY||||||=|0.134||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.134
91541838|NCT04714320|182963557|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.933
91541839|NCT04714320|182963557|SUPERIORITY||||||=|0.502||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.502
91541840|NCT04714320|182963557|SUPERIORITY||||||=|0.653||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.653
91541841|NCT04714320|182963557|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.816
91541842|NCT04714320|182963557|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.184
91541843|NCT04714320|182963557|SUPERIORITY||||||=|0.765||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.765
91541844|NCT04714320|182963557|SUPERIORITY||||||=|0.009||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.009
91541845|NCT04714320|182963557|SUPERIORITY||||||=|0.578||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.578
91541846|NCT04714320|182963557|SUPERIORITY||||||=|0.725||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.725
91541847|NCT04714320|182963557|SUPERIORITY||||||=|0.287||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.287
91541848|NCT04714320|182963557|SUPERIORITY||||||=|0.705||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.705
91541849|NCT04714320|182963557|SUPERIORITY||||||=|0.975||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.975
91541850|NCT04714320|182963557|SUPERIORITY||||||=|0.118||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.118
91541851|NCT04714320|182963557|SUPERIORITY||||||=|0.959||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.959
91541852|NCT04714320|182963557|SUPERIORITY||||||=|0.413||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.413
91541853|NCT04714320|182963557|SUPERIORITY||||||=|0.043||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.043
91541854|NCT04714320|182963557|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.849
91541855|NCT04714320|182963557|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.662
91541856|NCT04714320|182963557|SUPERIORITY||||||=|0.047||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.047
91541857|NCT04714320|182963557|SUPERIORITY||||||=|0.95||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.950
91541858|NCT04714320|182963557|SUPERIORITY||||||=|0.656||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.656
91541859|NCT04714320|182963557|SUPERIORITY||||||=|0.922||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.922
91541860|NCT04714320|182963557|SUPERIORITY||||||=|0.143||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.143
91541861|NCT04714320|182963557|SUPERIORITY||||||=|0.452||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.452
91541862|NCT04714320|182963557|SUPERIORITY||||||=|0.231||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.231
91541863|NCT04714320|182963557|SUPERIORITY||||||=|0.405||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.405
91541864|NCT04714320|182963557|SUPERIORITY||||||=|0.718||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.718
91541865|NCT04714320|182963557|SUPERIORITY||||||=|0.053||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.053
91541866|NCT04714320|182963557|SUPERIORITY||||||=|0.893||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.893
91541867|NCT04714320|182963557|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.662
91541868|NCT04714320|182963557|SUPERIORITY||||||=|0.688||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.688
91541869|NCT04714320|182963557|SUPERIORITY||||||=|0.611||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.611
91541870|NCT04714320|182963557|SUPERIORITY||||||=|0.907||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.907
91541871|NCT04714320|182963557|SUPERIORITY||||||=|0.699||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.699
91541872|NCT04714320|182963557|SUPERIORITY||||||=|0.802||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.802
91763890|NCT00286429|183418380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.19|TWO_SIDED|95.0|-24.7|4.9||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.9|-24.7|0.190
91541873|NCT04714320|182963557|SUPERIORITY||||||=|0.206||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.206
91541874|NCT04714320|182963558|SUPERIORITY||||||=|0.28||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.280
91541875|NCT04714320|182963558|SUPERIORITY||||||=|0.648||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.648
91541876|NCT04714320|182963558|SUPERIORITY||||||=|0.416||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.416
91541877|NCT04714320|182963558|SUPERIORITY||||||=|0.9||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.900
91541878|NCT04714320|182963558|SUPERIORITY||||||=|0.627||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.627
91541879|NCT04714320|182963558|SUPERIORITY||||||=|0.921||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.921
91541880|NCT04714320|182963558|SUPERIORITY||||||=|0.464||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.464
91541881|NCT04714320|182963558|SUPERIORITY||||||=|0.458||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.458
91541882|NCT04714320|182963558|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.779
91541883|NCT04714320|182963558|SUPERIORITY||||||=|0.629||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.629
91541884|NCT04714320|182963558|SUPERIORITY||||||=|0.242||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.242
91541885|NCT04714320|182963558|SUPERIORITY||||||=|0.29||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.290
91541886|NCT04714320|182963558|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.349
91541887|NCT04714320|182963558|SUPERIORITY||||||=|0.532||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.532
91541888|NCT04714320|182963558|SUPERIORITY||||||=|0.205||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.205
91541889|NCT04714320|182963558|SUPERIORITY||||||=|0.368||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.368
91541890|NCT04714320|182963558|SUPERIORITY||||||=|0.084||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.084
91763891|NCT00286429|183418380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.154|TWO_SIDED|95.0|-25.8|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-25.8|0.154
91763892|NCT00286429|183418381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.097|TWO_SIDED|95.0|-27.8|2.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||2.3|-27.8|0.097
91541891|NCT04714320|182963558|SUPERIORITY||||||=|0.179||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.179
91541892|NCT04714320|182963558|SUPERIORITY||||||=|0.584||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.584
91541893|NCT04714320|182963558|SUPERIORITY||||||=|0.762||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.762
91541894|NCT04714320|182963558|SUPERIORITY||||||=|0.675||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.675
91541895|NCT04714320|182963558|SUPERIORITY||||||=|0.166||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.166
91541896|NCT04714320|182963558|SUPERIORITY||||||=|0.09||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.090
91541897|NCT04714320|182963558|SUPERIORITY||||||=|0.488||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.488
91541898|NCT04714320|182963558|SUPERIORITY||||||=|0.218||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.218
91541899|NCT04714320|182963558|SUPERIORITY||||||=|0.232||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.232
91541900|NCT04714320|182963558|SUPERIORITY||||||=|0.421||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.421
91541901|NCT04714320|182963558|SUPERIORITY||||||=|0.815||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.815
91541902|NCT04714320|182963558|SUPERIORITY||||||=|0.711||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.711
91541903|NCT04714320|182963558|SUPERIORITY||||||=|0.514||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.514
91541904|NCT04714320|182963558|SUPERIORITY||||||=|0.479||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.479
91541905|NCT04714320|182963558|SUPERIORITY||||||=|0.292||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.292
91541906|NCT04714320|182963558|SUPERIORITY||||||=|0.528||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.528
91541907|NCT04714320|182963558|SUPERIORITY||||||=|0.946||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.946
91541908|NCT04714320|182963558|SUPERIORITY||||||=|0.552||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.552
91541909|NCT04714320|182963558|SUPERIORITY||||||=|0.598||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.598
91541910|NCT04714320|182963558|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.184
91541911|NCT04714320|182963558|SUPERIORITY||||||=|0.614||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.614
91541912|NCT04714320|182963558|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.933
91541913|NCT04714320|182963558|SUPERIORITY||||||=|0.803||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.803
91541914|NCT04714320|182963558|SUPERIORITY||||||=|0.686||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.686
91541915|NCT04714320|182963558|SUPERIORITY||||||=|0.752||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.752
91763893|NCT00286429|183418381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9||||0.01|TWO_SIDED|95.0|-35.1|-4.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.7|-35.1|0.010
91541916|NCT04714320|182963558|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.106
91541917|NCT04714320|182963558|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.779
91541918|NCT04714320|182963558|SUPERIORITY||||||=|0.323||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.323
91541919|NCT04714320|182963558|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.991
91541920|NCT04714320|182963558|SUPERIORITY||||||=|0.973||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.973
91541921|NCT04714320|182963558|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.230
91541922|NCT04714320|182963558|SUPERIORITY||||||=|0.792||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.792
91541923|NCT04714320|182963558|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.744
91541924|NCT04714320|182963558|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.925|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.925
91541925|NCT04714320|182963558|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.991
91541926|NCT04714320|182963558|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.53|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.530
91541927|NCT04714320|182963558|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.849
91541928|NCT04714320|182963558|SUPERIORITY||||||=|0.953||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.953
91541929|NCT04714320|182963558|SUPERIORITY||||||=|0.884||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.884
91541930|NCT04714320|182963558|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.230
91541931|NCT04714320|182963558|SUPERIORITY||||||=|0.589||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.589
91541932|NCT04714320|182963558|SUPERIORITY||||||=|0.919||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.919
91541933|NCT04714320|182963558|SUPERIORITY||||||=|0.753||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.753
91541934|NCT04714320|182963558|SUPERIORITY||||||=|0.747||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.747
91541935|NCT04714320|182963558|SUPERIORITY||||||=|0.764||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.764
91541936|NCT04714320|182963558|SUPERIORITY||||||=|0.527||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.527
91541937|NCT04714320|182963558|SUPERIORITY||||||=|0.639||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.639
91541938|NCT04714320|182963558|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.744
91541939|NCT04714320|182963558|SUPERIORITY||||||=|0.539||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.539
91541940|NCT04714320|182963558|SUPERIORITY||||||=|0.417||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.417
91541941|NCT04714320|182963558|SUPERIORITY||||||=|0.466||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.466
91541942|NCT04714320|182963558|SUPERIORITY||||||=|0.38||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.380
91541943|NCT04714320|182963558|SUPERIORITY||||||=|0.73||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.730
91763894|NCT00286429|183418382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.662|TWO_SIDED|95.0|-19.2|12.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||12.2|-19.2|0.662
91541944|NCT04714320|182963558|SUPERIORITY||||||=|0.595||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.595
91541945|NCT04714320|182963558|SUPERIORITY||||||=|0.279||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.279
91541946|NCT04714320|182963558|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.196
91541947|NCT04714320|182963558|SUPERIORITY||||||=|0.728||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.728
91541948|NCT04714320|182963558|SUPERIORITY||||||=|0.453||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.453
91541949|NCT04714320|182963558|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.681
91541950|NCT04714320|182963558|SUPERIORITY||||||=|0.863||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.863
91541951|NCT04714320|182963558|SUPERIORITY||||||=|0.837||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.837
91541952|NCT04714320|182963558|SUPERIORITY||||||=|0.504||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.504
91541953|NCT04714320|182963558|SUPERIORITY||||||=|0.531||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.531
91541954|NCT04714320|182963558|SUPERIORITY||||||=|0.6||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.600
91541955|NCT04714320|182963558|SUPERIORITY||||||=|0.83||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.830
91541956|NCT04714320|182963558|SUPERIORITY||||||=|0.209||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.209
91541957|NCT04714320|182963558|SUPERIORITY||||||=|0.809||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.809
91541958|NCT04714320|182963558|SUPERIORITY||||||=|0.045||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.045
91541959|NCT04714320|182963558|SUPERIORITY||||||=|0.104||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.104
91541960|NCT04714320|182963558|SUPERIORITY||||||=|0.69||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.690
91541961|NCT04714320|182963558|SUPERIORITY||||||=|0.59||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.590
91541962|NCT04714320|182963558|SUPERIORITY||||||=|0.538||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.538
91541963|NCT04714320|182963558|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.407
91541964|NCT04714320|182963558|SUPERIORITY||||||=|0.398||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.398
91541965|NCT04714320|182963558|SUPERIORITY||||||=|0.93||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.930
91541966|NCT04714320|182963558|SUPERIORITY||||||=|0.111||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.111
91541967|NCT04714320|182963558|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.196
91541968|NCT04714320|182963558|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.816
91541969|NCT04714320|182963558|SUPERIORITY||||||=|0.473||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.473
91541970|NCT04714320|182963558|SUPERIORITY||||||=|0.615||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.615
91541971|NCT04714320|182963558|SUPERIORITY||||||=|0.214||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.214
91541972|NCT04714320|182963558|SUPERIORITY||||||=|0.575||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.575
91541973|NCT04714320|182963558|SUPERIORITY||||||=|0.276||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.276
91541974|NCT04714320|182963558|SUPERIORITY||||||=|0.573||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.573
91541975|NCT04714320|182963558|SUPERIORITY||||||=|0.706||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.706
91541976|NCT04714320|182963559|SUPERIORITY||||||=|0.853||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 8||||=0.853
91541977|NCT04714320|182963559|SUPERIORITY||||||=|0.542||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.542
91541978|NCT04714320|182963559|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.430
91541979|NCT04714320|182963559|SUPERIORITY||||||=|0.587||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.587
91541980|NCT04714320|182963559|SUPERIORITY||||||=|0.91||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.910
91541981|NCT04714320|182963559|SUPERIORITY||||||=|0.846||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.846
91541982|NCT04714320|182963559|SUPERIORITY|||||||0.634||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||0.634
91541983|NCT04714320|182963559|SUPERIORITY||||||=|0.767||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.767
91763895|NCT00286429|183418382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6||||0.03|TWO_SIDED|95.0|-33.4|-1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.7|-33.4|0.030
91763896|NCT00286429|183418383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.551||||0.075|TWO_SIDED|95.0|0.286|1.063||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||1.063|0.286|0.075
91541984|NCT04714320|182963559|SUPERIORITY||||||=|0.399||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.399
91541985|NCT04714320|182963559|SUPERIORITY||||||=|0.323||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.323
91541986|NCT04714320|182963559|SUPERIORITY||||||=|0.115||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.115
91541987|NCT04714320|182963559|SUPERIORITY||||||=|0.982||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.982
91541988|NCT04714320|182963559|SUPERIORITY||||||=|0.859||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.859
91541989|NCT04714320|182963559|SUPERIORITY||||||=|0.344||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.344
91541990|NCT04714320|182963559|SUPERIORITY||||||=|0.633||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.633
91541991|NCT04714320|182963559|SUPERIORITY||||||=|0.889||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.889
91541992|NCT04714320|182963559|SUPERIORITY||||||=|0.241||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.241
91541993|NCT04714320|182963559|SUPERIORITY||||||=|0.367||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.367
91541994|NCT04714320|182963559|SUPERIORITY||||||=|0.716||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.716
91541995|NCT04714320|182963559|SUPERIORITY||||||=|0.21||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.210
91541996|NCT04714320|182963559|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.363
91541997|NCT04714320|182963559|SUPERIORITY||||||=|0.193||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.193
91541998|NCT04714320|182963559|SUPERIORITY||||||=|0.135||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.135
91541999|NCT04714320|182963559|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.867
91763897|NCT00286429|183418383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.002|TWO_SIDED|95.0|0.191|0.695||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.695|0.191|0.002
91763898|NCT00286429|183418384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.198|0.619||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo arm. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.619|0.198|<0.001
91763899|NCT00286429|183418384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.339|||<|0.001|TWO_SIDED|95.0|0.189|0.608||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.608|0.189|<0.001
91763900|NCT00286429|183418385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.286|TWO_SIDED|95.0|-0.131|0.443||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.443|-0.131|0.286
91542000|NCT04714320|182963559|SUPERIORITY||||||=|0.761||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.761
91542001|NCT04714320|182963559|SUPERIORITY||||||=|0.618||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.618
91542002|NCT04714320|182963559|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.363
91542003|NCT04714320|182963559|SUPERIORITY||||||=|0.125||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.125
91542004|NCT04714320|182963559|SUPERIORITY||||||=|0.435||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.435
91542005|NCT04714320|182963559|SUPERIORITY||||||=|0.413||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.413
91542006|NCT04714320|182963559|SUPERIORITY||||||=|0.658||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.658
91542007|NCT04714320|182963559|SUPERIORITY||||||=|0.275||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.275
91542008|NCT04714320|182963559|SUPERIORITY||||||=|0.578||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.578
91542009|NCT04714320|182963559|SUPERIORITY||||||=|0.114||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.114
91763901|NCT00286429|183418385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477||||0.001|TWO_SIDED|95.0|0.188|0.765||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.765|0.188|0.001
91542010|NCT04714320|182963560|SUPERIORITY||||||=|0.378||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.378
91542011|NCT04714320|182963560|SUPERIORITY||||||=|0.648||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.648
91542012|NCT04714320|182963560|SUPERIORITY||||||=|0.961||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.961
91542013|NCT04714320|182963560|SUPERIORITY||||||=|0.817||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.817
91542014|NCT04714320|182963560|SUPERIORITY||||||=|0.823||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.823
91542015|NCT04714320|182963560|SUPERIORITY||||||=|0.362||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.362
91542016|NCT04714320|182963560|SUPERIORITY||||||=|0.66||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.660
91542017|NCT04714320|182963560|SUPERIORITY||||||=|0.539||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.539
91542018|NCT04714320|182963560|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.430
91542019|NCT04714320|182963560|SUPERIORITY||||||=|0.594||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.594
91542020|NCT04714320|182963560|SUPERIORITY||||||=|0.783||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.783
91542021|NCT04714320|182963560|SUPERIORITY||||||=|0.599||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.599
91542022|NCT04714320|182963560|SUPERIORITY||||||=|0.454||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.454
91542023|NCT04714320|182963560|SUPERIORITY||||||=|0.394||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.394
91542024|NCT04714320|182963560|SUPERIORITY||||||=|0.93||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.930
91542025|NCT04714320|182963560|SUPERIORITY||||||=|0.313||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.313
91542026|NCT04714320|182963560|SUPERIORITY||||||=|0.276||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.276
91542027|NCT04714320|182963560|SUPERIORITY||||||=|0.168||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.168
91542028|NCT04714320|182963560|SUPERIORITY||||||=|0.199||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.199
91542029|NCT04714320|182963560|SUPERIORITY||||||=|0.506||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.506
91542030|NCT04714320|182963560|SUPERIORITY||||||=|0.32||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.320
91542031|NCT04714320|182963560|SUPERIORITY||||||=|0.25||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.250
91542032|NCT04714320|182963560|SUPERIORITY||||||=|0.373||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.373
91542033|NCT04714320|182963560|SUPERIORITY||||||=|0.597||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.597
91542034|NCT04714320|182963560|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.867
91542035|NCT04714320|182963560|SUPERIORITY||||||=|0.5||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.500
91542036|NCT04714320|182963560|SUPERIORITY||||||=|0.863||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.863
91542037|NCT04714320|182963560|SUPERIORITY||||||=|0.681||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.681
91542038|NCT04714320|182963560|SUPERIORITY||||||=|0.262||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.262
91542039|NCT04714320|182963560|SUPERIORITY||||||=|0.645||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.645
91542040|NCT04714320|182963560|SUPERIORITY||||||=|0.947||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.947
91542041|NCT04714320|182963560|SUPERIORITY||||||=|0.665||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.665
91542042|NCT04714320|182963560|SUPERIORITY||||||=|0.498||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.498
91542043|NCT04714320|182963560|SUPERIORITY||||||=|0.173||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.173
91542044|NCT04524390|182963596|SUPERIORITY||Least-Square mean|-0.39|STANDARD_ERROR_OF_MEAN|1.182||0.7419|TWO_SIDED|95.0|-2.76|1.97|||MMRM|||||1.97|-2.76|0.7419
91542045|NCT04524390|182963597|SUPERIORITY||Least-Square mean|-45.9|STANDARD_ERROR_OF_MEAN|35.398||0.2002|TWO_SIDED|95.0|-116.86|25.05|||MMRM|||||25.05|-116.86|0.2002
91542046|NCT04524390|182963598|SUPERIORITY|||||||0.8412|||||||Barnard's exact test|||||||0.8412
91542047|NCT04524390|182963599|SUPERIORITY||||||>|0.9999|||||||Barnard's exact test|||||||> 0.9999
91542048|NCT04524390|182963600|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
91542049|NCT04524390|182963601|SUPERIORITY|||||||0.6236|||||||Barnard's exact test|||||||0.6236
91542050|NCT04524390|182963602|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
91542051|NCT04524390|182963603|SUPERIORITY|||||||0.6659|||||||Barnard's exact test|||||||0.6659
91542052|NCT04928001|182963636|SUPERIORITY||Mean Difference (Final Values)|31.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||t-test, 1 sided|||||60|0|.01
91542053|NCT00077675|182963670|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%||||||0.5318|||||||2-sided 95% confidence interval calculat|||95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Difference||||0.5318
91542054|NCT04532528|182963682|OTHER|No formal hypotheses were tested.||||||0.9701|||||||Chi-squared|||||||0.9701
91542055|NCT04532528|182963683|OTHER|No formal hypotheses were tested.||||||0.7376|||||||Chi-squared|||At 3 months only||||0.7376
91542056|NCT04532528|182963683|OTHER|No formal hypotheses were tested.||||||0.1356|||||||Chi-squared|||At 6 months only||||0.1356
91542057|NCT04532528|182963683|OTHER|No formal hypotheses were tested.||||||0.68|||||||Chi-squared|||At 9 months only||||0.6800
91542058|NCT04532528|182963684|OTHER|No formal hypotheses were tested.||||||0.5777|||||||Chi-squared|||At 3 months only||||0.5777
91542059|NCT04532528|182963684|OTHER|No formal hypotheses were tested.||||||0.3313|||||||Chi-squared|||At 6 months only||||0.3313
91542060|NCT04532528|182963684|OTHER|No formal hypotheses was tested.||||||0.5697|||||||Chi-squared|||At 9 months only||||0.5697
91542061|NCT04532528|182963684|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Chi-squared|||At 12 months only||||0.5135
91542062|NCT04532528|182963685|OTHER|No formal hypotheses were tested.||||||0.8509|||||||Chi-squared|||At 3 months only||||0.8509
91542063|NCT04532528|182963685|OTHER|No formal hypotheses were tested.||||||0.3302|||||||Chi-squared|||At 6 months only||||0.3302
91542064|NCT04532528|182963685|OTHER|No formal hypotheses was tested.||||||0.9005|||||||Chi-squared|||At 9 months only||||0.9005
91542065|NCT04532528|182963685|OTHER|No formal hypotheses were tested.||||||0.2789|||||||Chi-squared|||At 12 months only||||0.2789
91542066|NCT04532528|182963686|OTHER|No formal hypotheses were tested.||||||0.667|||||||Wilcoxon (Mann-Whitney)|||At 3 months only||||0.6670
91542067|NCT04532528|182963686|OTHER|||||||0.1285|||||||Wilcoxon (Mann-Whitney)|||At 6 months only||||0.1285
91542068|NCT04532528|182963686|OTHER|No formal hypotheses was tested.||||||0.7151|||||||Wilcoxon (Mann-Whitney)|||At 9 months only||||0.7151
91542069|NCT04532528|182963686|OTHER|No formal hypotheses were tested||||||0.803|||||||Wilcoxon (Mann-Whitney)|||At 12 months only||||0.8030
91542070|NCT01068743|182963696|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|101.45|||||TWO_SIDED|90.0|98.17|104.84|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||104.84|98.17|
91542071|NCT01068743|182963696|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.43|||||TWO_SIDED|90.0|99.53|105.42|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf,respectively.||105.42|99.53|
91542072|NCT01068743|182963696|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.23||||||||||||||Geometric least squares means for Treatment A.||||
91542073|NCT01068743|182963696|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.94||||||||||||||Geometric least squares means for Treatment B.||||
91542074|NCT01068743|182963696|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|52.71||||||||||||||Geometric least squares means for Treatment C.||||
91763902|NCT00286429|183418386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202||||0.236|TWO_SIDED|95.0|-0.132|0.536||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.536|-0.132|0.236
91763903|NCT00286429|183418386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.032|TWO_SIDED|95.0|0.032|0.712||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.712|0.032|0.032
91763904|NCT00286429|183418387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126||||0.562|TWO_SIDED|95.0|-0.302|0.554||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.554|-0.302|0.562
91542075|NCT01068743|182963696|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|53.99||||||||||||||Geometric least squares means for Treatment D.||||
91542076|NCT01068743|182963699|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.46|||||TWO_SIDED|90.0|94.68|110.88|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||110.88|94.68|
91542077|NCT01068743|182963699|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|106.24|||||TWO_SIDED|90.0|98.43|114.66|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||114.66|98.43|
91542078|NCT01068743|182963699|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.73||||||||||||||Geometric least squares means for Treatment A.||||
91542079|NCT01068743|182963699|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.97||||||||||||||Geometric least squares means for Treatment B.||||
91542080|NCT01068743|182963699|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.33||||||||||||||Geometric least squares means for Treatment C.||||
91542081|NCT01068743|182963699|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.97||||||||||||||Geometric least squares means for Treatment D.||||
91542082|NCT01068743|182963700|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|102.1|||||TWO_SIDED|90.0|97.26|107.18|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||107.18|97.26|
91542083|NCT01068743|182963700|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.17|||||TWO_SIDED|90.0|96.23|102.21|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.21|96.23|
91542084|NCT01068743|182963700|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11998.0||||||||||||||Geometric least squares mean for Treatment A.||||
91542085|NCT01068743|182963700|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12250.0||||||||||||||Geometric least squares means for Treatment B.||||
91542086|NCT01068743|182963700|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12036.0||||||||||||||Geometric least squares means for Treatment C.||||
91542087|NCT01068743|182963700|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11937.0||||||||||||||Geometric least squares means for Treatment D.||||
91542088|NCT01068743|182963701|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.5|||||TWO_SIDED|90.0|90.41|109.5|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||109.5|90.41|
91542089|NCT01068743|182963701|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|98.22|||||TWO_SIDED|90.0|94.28|102.32|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.32|94.28|
91542090|NCT01068743|182963701|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL|1724.4||||||||||||||Geometric least squares means for Treatment A.||||
91542091|NCT01068743|182963701|SUPERIORITY_OR_OTHER||Geometric Least Square Means (ng/mL)|1715.8||||||||||||||Geometric least squares means for Treatment B.||||
91763905|NCT00286429|183418387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183||||0.407|TWO_SIDED|95.0|-0.251|0.616||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.616|-0.251|0.407
91542092|NCT01068743|182963701|SUPERIORITY_OR_OTHER||Geometric Least Square Mean (ng/mL)|1581.4||||||||||||||Geometric least squares means for Treatment C.||||
91542093|NCT01068743|182963701|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1553.2||||||||||||||Geometric least squares means for Treatment D.||||
91542094|NCT01068743|182963706|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|101.43|||||TWO_SIDED|90.0|98.07|104.9|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||104.90|98.07|
91542095|NCT01068743|182963706|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|102.52|||||TWO_SIDED|90.0|99.56|105.57|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||105.57|99.56|
91542096|NCT01068743|182963706|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.15|||||||||||||Geometric least squares means for Treatment A.|||||
91542097|NCT01068743|182963706|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.83|||||||||||||Geometric least squares means for Treatment B.|||||
91542098|NCT01068743|182963706|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|50.89|||||||||||||Geometric least squares means for Treatment C.|||||
91542099|NCT01068743|182963706|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|52.17|||||||||||||Geometric least squares means for Treatment D.|||||
91542100|NCT01068743|182963709|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|100.41|||||TWO_SIDED|90.0|95.4|105.68|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||105.68|95.40|
91542101|NCT01068743|182963709|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.06|||||TWO_SIDED|90.0|96.19|102.02|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||102.02|96.19|
91542102|NCT01068743|182963709|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11827.0|||||||||||||Geometric least squares means for Treatment A.|||||
91542103|NCT01068743|182963709|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11875.0|||||||||||||Geometric least squares means for Treatment B.|||||
91763906|NCT00286429|183418388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078||||0.716|TWO_SIDED|95.0|-0.344|0.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.500|-0.344|0.716
91542104|NCT01068743|182963709|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11845.0|||||||||||||Geometric least squares means for Treatment C.|||||
91542105|NCT01068743|182963709|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11734.0|||||||||||||Geometric least squares means for Treatment D.|||||
91542106|NCT03740009|182963735|NON_INFERIORITY|For analyses the researchers used a paired T-test to compare baseline and post-treatment mean activation values across 3 regions of interest (ROIs): the caudate, putamen and nucleus accumbens.||||||0.53|||||||t-test, 2 sided|||\[Ho\]: TSEC has no meaningful effect on activity within key nodes of the frontostriate in response to reward.||||0.53
91542107|NCT03740009|182963736|NON_INFERIORITY|Analysis included MASQ-AD scores from all visits to characterize the change in scores from baseline to post-treatment.|GLM|-5.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|||||Mixed models of 3 week TSEC administration for MASQ-AD scores assessed at each study visit from baseline to post-treatment.|GLM||F value=13.26|\[Ho\] No change in depressive symptoms from baseline throughout 3 weeks of TSEC administration||||<0.001
91542108|NCT01061151|182963737|SUPERIORITY||Risk Difference (RD)|-1.3|||||TWO_SIDED|96.5|-2.1|-0.4|||||The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan-DeMets approach with an O'Brien-Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).|Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.||-0.4|-2.1|
91542109|NCT01061151|182963738|SUPERIORITY|||||||0.008|||||||Fisher Exact|||Periods 1 and 2||||0.008
91542110|NCT01061151|182963738|SUPERIORITY|||||||0.77|||||||Fisher Exact|||Period 2||||0.77
91542111|NCT01061151|182963738|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Period 2||||>0.99
91542112|NCT01061151|182963739|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Periods 1 and 2||||0.30
91542113|NCT01061151|182963739|SUPERIORITY|||||||0.64|||||||Fisher Exact|||Period 2||||0.64
91542114|NCT01061151|182963739|SUPERIORITY|||||||0.06|||||||Fisher Exact|||Period 2||||0.06
91542115|NCT01061151|182963740|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Periods 1 and 2||||<0.001
91542116|NCT01061151|182963740|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Period 2||||0.04
91542117|NCT01061151|182963740|SUPERIORITY|||||||0.46|||||||Fisher Exact|||Period 2||||0.46
91542118|NCT01061151|182963741|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|96.0|0.3|3.1|||||The confidence interval was based on a repeated confidence interval.|||3.1|0.3|
91542119|NCT01061151|182963742|SUPERIORITY|||||||0.98|||||||Log Rank|||||||0.98
91542120|NCT01061151|182963743|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.37|TWO_SIDED|95.0|0.14|2.08|||Log Rank||The hazard ratio compares Arm A relative to Arm B.|||2.08|0.14|0.37
91542121|NCT01061151|182963745|SUPERIORITY|||||||0.16|||||||Two-sided Z test|||Overall survival||||0.16
91542122|NCT01061151|182963745|SUPERIORITY|||||||0.0156|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0156
91542123|NCT01061151|182963745|SUPERIORITY|||||||0.31|||||||Two-sided Z test|||Overall survival, period 2 group||||0.31
91542124|NCT01061151|182963745|SUPERIORITY|||||||0.0022|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0022
91542125|NCT01061151|182963745|SUPERIORITY|||||||0.13|||||||Two-sided Z test|||HIV-free survival||||0.13
91542126|NCT01061151|182963745|SUPERIORITY|||||||0.44|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.44
91542127|NCT01061151|182963745|SUPERIORITY|||||||0.24|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.24
91542128|NCT01061151|182963745|SUPERIORITY|||||||0.26|||||||Two-sided Z test|||HIV-free survival, group 2||||0.26
91542129|NCT03926039|182963774|EQUIVALENCE|Equivalence Analysis||||||0.05|||||||ANOVA|||Both group of average difference (95% CI) in intervention group and control group||||0.05
91542130|NCT01266122|182963787|SUPERIORITY_OR_OTHER||log(Incident Risk Ratio)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.44|||Mixed Models Analysis|Mixed effects Poisson regression||Intent to treat analysis||-.44|-1.47|<.001
91542131|NCT01266122|182963788|SUPERIORITY_OR_OTHER||Chi-square statistic|1.39|||=|0.239|TWO_SIDED||||||Chi-squared|||Intent to treat analysis.||||=.239
91542132|NCT03756571|182963790|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91542133|NCT03756571|182963791|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
91542134|NCT03756571|182963792|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91542135|NCT03756571|182963793|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
91542136|NCT03756571|182963794|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
91542137|NCT03756571|182963795|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
91542138|NCT03756571|182963796|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
91542139|NCT03756571|182963797|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
91542140|NCT03756571|182963798|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91542141|NCT03756571|182963799|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
91542142|NCT03756571|182963800|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
91542143|NCT03756571|182963801|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
91542144|NCT03752151|182963802|SUPERIORITY||||||<|0.001|||||||McNemar|||The null hypothesis was that the probability of meeting the endpoint (Atrioventricular synchrony \>70%) was the same in MARVEL 2 Monitor Mode and MARVEL 2 Adaptive Mode. A sample size of 35 participants with a predominant rhythm of 3rd degree atrioventricular block and normal sinus function provided \>90% power at a type I error rate of 0.05 assuming the proportion of patients meeting the endpoint in one mode, but not the other exceeded 50% and 90% of these pairs favored the Adaptive mode.||||<0.001
91542145|NCT03752151|182963803|SUPERIORITY||proportion expressed as a percentage|100.0|||<|0.001|TWO_SIDED|95.0|95.2|100.0|||Exact binomial test|||The null hypothesis is that 87% or fewer participants will achieve the endpoint. The alternative hypothesis is that more than 87% of participants will achieve the endpoint. A sample size of 70 participants provides at least 90% power to test the null hypothesis assuming the true rate of meeting the endpoint in the population is 98% at a type I error rate of 2.5%.||100|95.2|<0.001
91542146|NCT03752151|182963804|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.002|TWO_SIDED|95.0|0.7|2.7|||t-test, 2 sided|Paired t-test since each participant had LVOT VTI measurements in MARVEL 2 Adaptive and Monitor modes||The null hypothesis is that the mean LVOT VTI during MARVEL 2 Adaptive mode equals the mean LVOT VTI during MARVEL 2 Monitor mode. A sample size of 35 participants with paired LVOT VTI measurements provides 89% power at a type I error rate of 5% to reject the null hypothesis assuming the true difference in LVOT VTI is 2.1 cm with a standard deviation of 3.8 cm.||2.7|0.7|0.002
91542147|NCT03224390|182963828|SUPERIORITY||Instrumental variables estimate|0.41|||||TWO_SIDED|95.0|-0.03|0.85||||||||.85|-.03|
91542148|NCT00703820|182963835|SUPERIORITY||Odds Ratio (OR)|1.87||||0.035|TWO_SIDED|95.0|1.03|3.41||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using an exact, risk-group stratified, two-sided test.|The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.|The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.||3.41|1.03|0.035
91542149|NCT00736853|182963907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.221|0.641|||Log Rank|Stratified Log-rank test with the target disease as the stratification factor||||0.641|0.221|0.0001
91542150|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.9|0.75|1.07||||||ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.07|0.75|
91542151|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.77|1.14||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.77|
91542152|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.88|||||TWO_SIDED|95.9|0.75|1.03||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.03|0.75|
91542153|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.93|||||TWO_SIDED|95.9|0.71|1.23||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.71|
91542154|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.81|1.1||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.10|0.81|
91542155|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.89|||||TWO_SIDED|95.9|0.76|1.06||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.06|0.76|
91542156|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.96|||||TWO_SIDED|95.9|0.81|1.15||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.15|0.81|
91542157|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.92|||||TWO_SIDED|95.9|0.74|1.14||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.74|
91542158|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.0|||||TWO_SIDED|95.9|0.81|1.23||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.81|
91542159|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.15|||||TWO_SIDED|95.9|0.89|1.48||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.48|0.89|
91542160|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.71|||||TWO_SIDED|95.9|1.44|2.03||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||2.03|1.44|
91542161|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.72|1.02||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.02|0.72|
91542162|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.7|1.05||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.05|0.70|
91542163|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.78|1.07||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.07|0.78|
91542164|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.84||||||95.8|0.64|1.11||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.11|0.64|
91542165|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.8|0.76|1.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.06|0.76|
91542166|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.79|||||TWO_SIDED|95.8|0.67|0.93||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||0.93|0.67|
91542167|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.77|1.09||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.09|0.77|
91542168|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.01|||||TWO_SIDED|95.8|0.81|1.26||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.26|0.81|
91542169|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.12|||||TWO_SIDED|95.8|0.9|1.38||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.38|0.90|
91763907|NCT00286429|183418388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.474|TWO_SIDED|95.0|-0.272|0.583||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.583|-0.272|0.474
91763908|NCT00286429|183418389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.7|TWO_SIDED|95.0|-0.324|0.482||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.482|-0.324|0.700
91763909|NCT00286429|183418389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.839|TWO_SIDED|95.0|-0.366|0.45||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.450|-0.366|0.839
91542170|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..|Adjusted GMCs ratio|1.05|||||TWO_SIDED|95.8|0.81|1.37||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.37|0.81|
91542171|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.9|||||TWO_SIDED|95.8|1.51|2.39||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.39|1.51|
91542172|NCT01616459|182963938|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|2.32|||||TWO_SIDED|95.8|1.94|2.77||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.77|1.94|
91542173|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.9|-3.89|1.36||||||ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.36|-3.89|
91542174|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.08|||||TWO_SIDED|95.9|-4.94|2.45||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.45|-4.94|
91542175|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.48|||||TWO_SIDED|95.9|-2.82|1.38||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.38|-2.82|
91763910|NCT00286429|183418390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.091|TWO_SIDED|95.0|-0.045|0.61||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.610|-0.045|0.091
91542176|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.24|||||TWO_SIDED|95.9|-10.65|6.13||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||6.13|-10.65|
91542177|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.03|||||TWO_SIDED|95.9|-2.39|2.21||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.21|-2.39|
91542178|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.4|||||TWO_SIDED|95.9|-2.36|3.22||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.22|-2.36|
91542179|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.45|||||TWO_SIDED|95.9|-1.51|2.66||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.66|-1.51|
91542180|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.0|||||TWO_SIDED|95.9|-4.18|1.7||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.70|-4.18|
91542181|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.38|||||TWO_SIDED|95.9|-5.64|-0.52||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||-0.52|-5.64|
91542182|NCT01616459|182963939|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.73|||||TWO_SIDED|95.9|-4.84|10.25||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||10.25|-4.84|
91542183|NCT01616459|182963940|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.89|||||TWO_SIDED|95.9|-1.46|3.66||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.66|-1.46|
91542184|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.49|||||TWO_SIDED|95.8|-3.44|2.22||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.22|-3.44|
91542185|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.06|||||TWO_SIDED|95.8|-4.03|3.86||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.86|-4.03|
91542186|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.01|||||TWO_SIDED|95.8|-2.37|2.3||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.30|-2.37|
91542187|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-4.67|||||TWO_SIDED|95.8|-12.94|3.6||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.60|-12.94|
91542188|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.46|||||TWO_SIDED|95.8|-1.93|3.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.06|-1.93|
91542189|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.02|||||TWO_SIDED|95.8|-2.72|2.64||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.64|-2.72|
91542190|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.0|||||TWO_SIDED|95.8|-1.94|1.9||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||1.90|-1.94|
91542191|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.5|||||TWO_SIDED|95.8|-3.72|2.52||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.52|-3.72|
91542192|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.8|-4.38|2.1||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.10|-4.38|
91542193|NCT01616459|182963941|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.5|||||TWO_SIDED|95.8|-5.07|10.06||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||10.06|-5.07|
91542194|NCT01616459|182963942|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|11.22|||||TWO_SIDED|95.8|7.22|16.49||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||16.49|7.22|
91542195|NCT01616459|182963942|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|3.75|||||TWO_SIDED|95.8|1.03|7.57||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||7.57|1.03|
91542196|NCT05165485|182963977|SUPERIORITY||Mean Difference (Net)|-23.0||||0.22|TWO_SIDED|95.0|-61.0|14.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence, stopping after the first failure to reject the null hypothesis.|Mixed Models Analysis|Denominator degrees of freedom were approximated by the Kenward and Roger (1997) method.|Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|14|-61|0.22
91542197|NCT05165485|182963978|SUPERIORITY||Mean Difference (Net)|-9.0|||||TWO_SIDED|95.0|-38.0|20.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The OTE is defined as the average of the Day 30, Day 60, and Day 85 Revefenacin - Tiotropium Least Squares Mean differences. The null hypothesis was that the OTE Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|20|-38|
91542198|NCT05165485|182963979|SUPERIORITY||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|-29.0|32.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|32|-29|
91542199|NCT05165485|182963980|SUPERIORITY||Mean Difference (Net)|-6.0|||||TWO_SIDED|95.0|-40.0|29.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|29|-40|
91763911|NCT00286429|183418390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.459|TWO_SIDED|95.0|-0.207|0.457||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.457|-0.207|0.459
91542200|NCT05165485|182963981|SUPERIORITY||Mean Difference (Net)|-41.0|||||TWO_SIDED|95.0|-118.0|35.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference.|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FVC, screening FVC, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|35|-118|
91542201|NCT05165485|182963982|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.39|0.92||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Logistic||The profile likelihood method was used to estimate the Revefenacin / Tiotropium responder OR.|The null hypothesis was that the Revefenacin / Tiotropium responder Odds Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium responder OR was estimated by fitting a logistic regression model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|0.92|0.39|
91542202|NCT05165485|182963983|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.69|1.45||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Cox||The profile likelihood method was used to estimate the Revefenacin / Tiotropium HR.|The null hypothesis was that the Revefenacin / Tiotropium CompEx Event Hazard Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium HR was estimated by fitting a Cox proportional hazards model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|1.45|0.69|
91542203|NCT03237481|182963984|SUPERIORITY||Least Squares Mean Difference (LSMD)|-81.43|STANDARD_ERROR_OF_MEAN|22.592|=|0.0004|TWO_SIDED|95.0|-125.83|-37.02|||ANOVA|||||-37.02|-125.83|= 0.0004
91542204|NCT03237481|182963985|SUPERIORITY||Least Squares Mean Difference (LSMD)|-72.49|STANDARD_ERROR_OF_MEAN|18.23|<|0.0001|TWO_SIDED|95.0|-108.32|-36.65|||ANOVA|||||-36.65|-108.32|< 0.0001
91542205|NCT03237481|182963986|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0001
91542206|NCT03237481|182963987|SUPERIORITY||Risk Difference (RD)|0.111|||=|0.0486|TWO_SIDED|95.0|0.003|0.218|||Fisher Exact|||||0.218|0.003|= 0.0486
91542207|NCT03237481|182963988|SUPERIORITY||||||=|0.024|||||||Wilcoxon (Mann-Whitney)|||||||= 0.024
91542208|NCT02566902|182963997|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91542209|NCT02566902|182963998|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91542210|NCT02566902|182963999|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91542211|NCT02566902|182964000|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
91542212|NCT02566902|182964001|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
91542213|NCT02566902|182964002|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91542214|NCT02374463|182964013|SUPERIORITY||||||<|0.05||||||P value not adjusted for multiple comparisons|t-test, 2 sided|||within group change was assessed||||<0.05
91542215|NCT02374463|182964014|SUPERIORITY||||||=|0.08||||||p value not adjusted for multiple comparisons|ANOVA|||||||=0.08
91542216|NCT02374463|182964015|SUPERIORITY||||||=|0.6|||||||ANOVA|not adjusted for multiple comparisons||||||=0.6
91542217|NCT02374463|182964016|SUPERIORITY|||||||0.84||||||Not adjusted for multiple comparisons|Chi-squared|exploratory aim prespecified.||||||0.84
91542218|NCT02374463|182964016|SUPERIORITY||||||=|0.4|||||||Chi-squared|||||||=0.4
91542219|NCT02374463|182964017|SUPERIORITY||||||=|0.3||||||not adjusted for multiple comparisons|ANOVA|||||||=0.3
91542220|NCT02374463|182964018|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91542221|NCT01305252|182964019|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
91542222|NCT01305252|182964019|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
91542223|NCT01305252|182964022|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
91542224|NCT01305252|182964022|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
91542225|NCT04723394|182964036|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|50.38||||0.01|TWO_SIDED|95.0|14.38|71.25|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||71.25|14.38|0.010
91542226|NCT04723394|182964037|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|49.24||||0.009|TWO_SIDED|95.0|14.72|69.79|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||69.79|14.72|0.009
91542227|NCT00253890|182964043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.7||||0.05||95.0|||||t-test, 2 sided|||Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.||||.05
91542228|NCT02765100|182964046|EQUIVALENCE|Unless specified otherwise, each of the statistical tests above will use a two-tailed alpha-level of 0.05.|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|3.4|<|0.05|TWO_SIDED||||||t-test, 2 sided|||This is a pilot proof of concept study and does not require formal sample size calculations. High and low CRP groups will be compared on demographic, clinical and biological variables using two-sample t-tests or analysis of variance (ANOVA) tests for continuous variables (for nonparametric continuous variables, either Mann-Whitney tests or Kruskal-Wallis tests will be used) and chi-square tests or Fisher's exact tests for categorical variables.||||<0.05
91542229|NCT00174382|182964107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.33||0.182||95.0|-0.21|1.09||Baseline value, center, and week as fixed effects; subject was included as a random effect.|Mixed Models Analysis|||Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.09|-0.21|0.182
91542230|NCT00174382|182964107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.067||95.0|-0.05|1.36|||Mixed Models Analysis|||Week 24 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.36|-0.05|0.067
91542231|NCT00174382|182964107|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Mixed Models Analysis|||Week 24 LOCF Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||||0.085
91542232|NCT00174382|182964108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.16||0.218||95.0|-1.2|5.19|||Mixed Models Analysis|||||5.19|-1.20|0.218
91542233|NCT00174382|182964108|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.12||0.385||95.0|-6.03|2.34|||Mixed Models Analysis|||||2.34|-6.03|0.385
91542234|NCT00174382|182964108|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Mixed Models Analysis|||||||0.228
91542235|NCT00174382|182964109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.84|STANDARD_ERROR_OF_MEAN|2.19||0.404||95.0|-2.51|6.18|||Mixed Models Analysis|||||6.18|-2.51|0.404
91542236|NCT00174382|182964109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|2.56||0.826||95.0|-4.51|5.64|||Mixed Models Analysis|||||5.64|-4.51|0.826
91542237|NCT00174382|182964109|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||Mixed Models Analysis|||||||0.494
91542238|NCT00174382|182964110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78|STANDARD_ERROR_OF_MEAN|1.61||0.272||95.0|-1.42|4.99|||Mixed Models Analysis|||||4.99|-1.42|0.272
91542239|NCT00174382|182964110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|2.0||0.894||95.0|-4.21|3.68|||Mixed Models Analysis|||||3.68|-4.21|0.894
91542240|NCT00174382|182964110|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Mixed Models Analysis|||||||0.906
91542241|NCT00174382|182964111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.35||0.719||95.0|-0.56|0.82|||Mixed Models Analysis|||||0.82|-0.56|0.719
91542242|NCT00174382|182964111|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.36||0.006||95.0|0.29|1.71|||Mixed Models Analysis|||||1.71|0.29|0.006
91542243|NCT00174382|182964111|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|||||||0.007
91542244|NCT00174382|182964112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.368||95.0|-0.38|1.01|||Mixed Models Analysis|||||1.01|-0.38|0.368
91542245|NCT00174382|182964112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.33||0.03||95.0|0.07|1.37|||Mixed Models Analysis|||||1.37|0.07|0.030
91542246|NCT00174382|182964112|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Mixed Models Analysis|||||||0.060
91542247|NCT00174382|182964113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.516||95.0|-0.44|0.86|||Mixed Models Analysis|||||0.86|-0.44|0.516
91542248|NCT00174382|182964113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.32||0.297||95.0|-0.97|0.3|||Mixed Models Analysis|||||0.30|-0.97|0.297
91542249|NCT00174382|182964113|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||Mixed Models Analysis|||||||0.133
91542250|NCT00174382|182964114|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|0.33||0.02||95.0|0.13|1.45|||Mixed Models Analysis|||||1.45|0.13|0.020
91542251|NCT00174382|182964114|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.36||0.018||95.0|0.16|1.59|||Mixed Models Analysis|||||1.59|0.16|0.018
91542252|NCT00174382|182964114|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||0.004
91542253|NCT00174382|182964115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.01||95.0|-1.93|-0.27|||Mixed Models Analysis|||||-0.27|-1.93|0.010
91542254|NCT00174382|182964115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.47||0.018||95.0|-2.05|-0.19|||Mixed Models Analysis|||||-0.19|-2.05|0.018
91542255|NCT00174382|182964115|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
91542256|NCT00174382|182964116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.62||0.182||95.0|-2.06|0.39|||Mixed Models Analysis|||||0.39|-2.06|0.182
91542257|NCT00174382|182964116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.68||0.114||95.0|-2.44|0.26|||Mixed Models Analysis|||||0.26|-2.44|0.114
91542258|NCT00174382|182964116|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Mixed Models Analysis|||||||0.038
91542259|NCT03903822|182964121|SUPERIORITY||Least square (LS) mean difference|-13.9|STANDARD_ERROR_OF_MEAN|11.04||0.104|TWO_SIDED|90.0|-32.1|4.3|||ANCOVA|||Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.||4.3|-32.1|0.1040
91542260|NCT03903822|182964121|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|11.0||0.0334|TWO_SIDED|90.0|-38.3|-2.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-2.1|-38.3|0.0334
91542261|NCT03903822|182964121|SUPERIORITY||LS Mean Difference|-25.6|STANDARD_ERROR_OF_MEAN|10.75||0.0086|TWO_SIDED|90.0|-43.3|-8.0|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-8.0|-43.3|0.0086
91542262|NCT03903822|182964121|SUPERIORITY||LS Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.93||0.0158|TWO_SIDED|90.0|-41.5|-5.5|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-5.5|-41.5|0.0158
91542263|NCT03903822|182964121|SUPERIORITY||LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.11||0.0879|TWO_SIDED|90.0|-24.3|2.4|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||2.4|-24.3|0.0879
91542264|NCT03903822|182964121|SUPERIORITY||LS Mean Difference|-27.4|STANDARD_ERROR_OF_MEAN|8.11||0.0004|TWO_SIDED|90.0|-40.7|-14.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-14.1|-40.7|0.0004
91542265|NCT03903822|182964122|SUPERIORITY||Risk Difference (RD)|18.9||||0.0244|TWO_SIDED|90.0|2.4|34.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||34.7|2.4|0.0244
91542266|NCT03903822|182964122|SUPERIORITY||Risk Difference (RD)|22.5||||0.0113|TWO_SIDED|90.0|4.8|38.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||38.6|4.8|0.0113
91542267|NCT03903822|182964122|SUPERIORITY||Risk Difference (RD)|29.7||||0.0018|TWO_SIDED|90.0|11.0|45.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||45.7|11.0|0.0018
91542268|NCT03903822|182964122|SUPERIORITY||Risk Difference (RD)|33.6||||0.0007|TWO_SIDED|90.0|13.7|49.9|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||49.9|13.7|0.0007
91542269|NCT03903822|182964122|SUPERIORITY||Risk Difference (RD)|19.4||||0.0289|TWO_SIDED|90.0|1.8|36.5|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||36.5|1.8|0.0289
91542270|NCT03903822|182964122|SUPERIORITY||Risk Difference (RD)|13.1||||0.1145|TWO_SIDED|90.0|-2.9|29.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||29.6|-2.9|0.1145
91542271|NCT03903822|182964123|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.79||0.0488|TWO_SIDED|90.0|-2.61|-0.01|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.01|-2.61|0.0488
91542272|NCT03903822|182964123|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.788||0.0413|TWO_SIDED|90.0|-2.66|-0.07|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.07|-2.66|0.0413
91542273|NCT03903822|182964123|SUPERIORITY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.773||0.02|TWO_SIDED|90.0|-2.86|-0.32|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.32|-2.86|0.0200
91542274|NCT03903822|182964123|SUPERIORITY||LS Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.758||0.0011|TWO_SIDED|90.0|-3.58|-1.08|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-1.08|-3.58|0.0011
91542275|NCT03903822|182964123|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.535||0.0727|TWO_SIDED|90.0|-1.66|0.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||0.10|-1.66|0.0727
91542276|NCT03903822|182964123|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.534||0.001|TWO_SIDED|90.0|-2.52|-0.77|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.77|-2.52|0.0010
91542277|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|0.5||||0.5246|TWO_SIDED|90.0|-14.7|16.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||16.4|-14.7|0.5246
91542278|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|3.8||||0.3906|TWO_SIDED|90.0|-12.5|19.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||19.9|-12.5|0.3906
91542279|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|13.5||||0.1193|TWO_SIDED|90.0|-3.2|30.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||30.6|-3.2|0.1193
91542280|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|28.2||||0.0048|TWO_SIDED|90.0|8.8|45.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||45.5|8.8|0.0048
91542281|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|14.7||||0.0777|TWO_SIDED|90.0|-2.0|31.1|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.1|-2.0|0.0777
91542282|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|11.8||||0.1245|TWO_SIDED|90.0|-4.3|28.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.0|-4.3|0.1245
91542283|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|6.2||||0.3322|TWO_SIDED|90.0|-12.2|24.4|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||24.4|-12.2|0.3322
91542284|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|18.5||||0.0535|TWO_SIDED|90.0|-0.3|36.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||36.5|-0.3|0.0535
91542285|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|24.3||||0.0159|TWO_SIDED|90.0|4.5|41.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.9|4.5|0.0159
91542286|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|36.8||||0.0008|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||54.0|15.4|0.0008
91542287|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|20.7||||0.0386|TWO_SIDED|90.0|1.5|38.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||38.8|1.5|0.0386
91542288|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|12.1||||0.1485|TWO_SIDED|90.0|-6.4|30.3|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||30.3|-6.4|0.1485
91542289|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|17.3||||0.062|TWO_SIDED|90.0|-0.8|34.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||34.8|-0.8|0.0620
91542290|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|26.9||||0.0089|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||44.4|6.5|0.0089
91542291|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|37.8||||0.0005|TWO_SIDED|90.0|17.5|54.7|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.7|17.5|0.0005
91542292|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|36.7||||0.0007|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.0|15.4|0.0007
91542293|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|18.1||||0.0711|TWO_SIDED|90.0|-2.0|37.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||37.5|-2.0|0.0711
91542294|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|23.8||||0.0266|TWO_SIDED|90.0|2.7|42.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||42.5|2.7|0.0266
91542295|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|3.8||||0.4173|TWO_SIDED|90.0|-15.3|23.1|||Chan and Zhang Exact Method|||At week 4: Risk difference = difference in percentage of participants.||23.1|-15.3|0.4173
91542296|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|16.3||||0.1096|TWO_SIDED|90.0|-4.3|35.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||35.6|-4.3|0.1096
91542297|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|27.0||||0.0133|TWO_SIDED|90.0|6.1|45.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.7|6.1|0.0133
91542298|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|23.2||||0.0304|TWO_SIDED|90.0|2.6|41.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||41.7|2.6|0.0304
91542299|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
91542300|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
91542301|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|1.1||||0.4966|TWO_SIDED|90.0|-18.4|20.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||20.4|-18.4|0.4966
91542302|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|10.9||||0.2753|TWO_SIDED|90.0|-9.3|30.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.1|-9.3|0.2753
91542303|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|16.2||||0.1036|TWO_SIDED|90.0|-4.2|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-4.2|0.1036
91542304|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|20.6||||0.0457|TWO_SIDED|90.0|0.4|39.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||39.6|0.4|0.0457
91542305|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
91542306|NCT03903822|182964124|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
91542307|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|3.3||||0.245|TWO_SIDED|90.0|-5.4|14.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.9|-5.4|0.2450
91542308|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|3.1||||0.2575|TWO_SIDED|90.0|-5.3|14.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.0|-5.3|0.2575
91542309|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|16.1||||0.0087|TWO_SIDED|90.0|5.7|31.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.0|5.7|0.0087
91542310|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|10.7||||0.0392|TWO_SIDED|90.0|0.8|25.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.4|0.8|0.0392
91542311|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-11.2|11.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||11.2|-11.2|1.0000
91542312|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|7.8||||0.1528|TWO_SIDED|90.0|-4.9|22.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||22.5|-4.9|0.1528
91542313|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|0.9||||0.4989|TWO_SIDED|90.0|-12.7|15.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||15.2|-12.7|0.4989
91542314|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|0.3||||0.5419|TWO_SIDED|90.0|-13.6|14.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||14.2|-13.6|0.5419
91542315|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
91542316|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|15.9||||0.0541|TWO_SIDED|90.0|-0.4|33.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||33.9|-0.4|0.0541
91542317|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|3.3||||0.3945|TWO_SIDED|90.0|-12.0|19.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||19.5|-12.0|0.3945
91542318|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|23.3||||0.0201|TWO_SIDED|90.0|3.9|41.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.8|3.9|0.0201
91542319|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|11.2||||0.1372|TWO_SIDED|90.0|-5.4|28.2|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||28.2|-5.4|0.1372
91542320|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|3.5||||0.3924|TWO_SIDED|90.0|-11.6|19.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||19.1|-11.6|0.3924
91542321|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|20.1||||0.0311|TWO_SIDED|90.0|2.4|38.3|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.3|2.4|0.0311
91542322|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|20.0||||0.0392|TWO_SIDED|90.0|0.8|38.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.1|0.8|0.0392
91542323|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|10.0||||0.1541|TWO_SIDED|90.0|-6.2|26.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||26.4|-6.2|0.1541
91542324|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
91542325|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|8.5||||0.2835|TWO_SIDED|90.0|-9.5|27.0|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.0|-9.5|0.2835
91763912|NCT00286429|183418392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.65||||0.016|TWO_SIDED|95.0|1.589|100.682||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||100.682|1.589|0.016
91763913|NCT00286429|183418392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.255||||0.023|TWO_SIDED|95.0|1.401|90.379||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo was evaluated inferentially with a Wald test at the 0.05 significance level||90.379|1.401|0.023
91763914|NCT00286429|183418393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.777|||<|0.001|TWO_SIDED|95.0|2.047|16.305||No multiplicity adjustments.|ANCOVA|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||16.305|2.047|<0.001
91542326|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|9.9||||0.27|TWO_SIDED|90.0|-8.7|27.8|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.8|-8.7|0.2700
91542327|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|17.3||||0.0662|TWO_SIDED|90.0|-1.4|36.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.2|-1.4|0.0662
91542328|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
91542329|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|20.0||||0.0302|TWO_SIDED|90.0|2.2|38.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||38.3|2.2|0.0302
91542330|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
91542331|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|11.8||||0.1561|TWO_SIDED|90.0|-6.5|30.2|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.2|-6.5|0.1561
91542332|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|16.2||||0.0753|TWO_SIDED|90.0|-2.7|34.8|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||34.8|-2.7|0.0753
91542333|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|27.0||||0.0108|TWO_SIDED|90.0|5.7|46.0|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||46.0|5.7|0.0108
91542334|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
91542335|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|16.7||||0.0775|TWO_SIDED|90.0|-2.9|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-2.9|0.0775
91763915|NCT00286429|183418393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.784|||<|0.001|TWO_SIDED|95.0|3.54|27.039||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||27.039|3.540|<0.001
91542336|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|24.1||||0.0243|TWO_SIDED|90.0|3.4|43.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||43.4|3.4|0.0243
91542337|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|20.9||||0.0234|TWO_SIDED|90.0|3.5|38.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||38.8|3.5|0.0234
91542338|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|12.8||||0.1134|TWO_SIDED|90.0|-2.8|29.3|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.3|-2.8|0.1134
91542339|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
91542340|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|12.3||||0.1029|TWO_SIDED|90.0|-3.4|29.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.8|-3.4|0.1029
91542341|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-17.9|17.9|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||17.9|-17.9|1.0000
91542342|NCT03903822|182964125|SUPERIORITY||Risk Difference (RD)|-12.6||||0.8972|TWO_SIDED|90.0|-28.8|3.5|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||3.5|-28.8|0.8972
91542343|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33||0.4781|TWO_SIDED|90.0|-14.2|13.3|||Mixed Model Repeated Measure|||At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||13.3|-14.2|0.4781
91542344|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-13.8|STANDARD_ERROR_OF_MEAN|8.47||0.0522|TWO_SIDED|90.0|-27.8|0.2|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.2|-27.8|0.0522
91542345|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-17.5|STANDARD_ERROR_OF_MEAN|8.37||0.0187|TWO_SIDED|90.0|-31.4|-3.7|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-3.7|-31.4|0.0187
91542346|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|8.45||0.008|TWO_SIDED|90.0|-34.5|-6.6|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-6.6|-34.5|0.0080
91542347|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-25.0|STANDARD_ERROR_OF_MEAN|14.17||0.0401|TWO_SIDED|90.0|-48.6|-1.5|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.5|-48.6|0.0401
91542348|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-25.5|STANDARD_ERROR_OF_MEAN|14.25||0.0379|TWO_SIDED|90.0|-49.2|-1.9|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.9|-49.2|0.0379
91542349|NCT03903822|182964126|SUPERIORITY||LS Mean difference|8.1|STANDARD_ERROR_OF_MEAN|11.01||0.7678|TWO_SIDED|90.0|-10.1|26.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||26.3|-10.1|0.7678
91542350|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-22.8|STANDARD_ERROR_OF_MEAN|10.94||0.0193|TWO_SIDED|90.0|-40.9|-4.7|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-4.7|-40.9|0.0193
91542351|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-28.3|STANDARD_ERROR_OF_MEAN|10.95||0.0052|TWO_SIDED|90.0|-46.5|-10.2|||Mixed Model Repeated Measure|||At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.2|-46.5|0.0052
91542352|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-23.7|STANDARD_ERROR_OF_MEAN|11.03||0.0164|TWO_SIDED|90.0|-42.0|-5.5|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-5.5|-42.0|0.0164
91542353|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-31.7|STANDARD_ERROR_OF_MEAN|9.72||0.0008|TWO_SIDED|90.0|-47.8|-15.6|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-47.8|0.0008
91542354|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-40.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.0001|TWO_SIDED|90.0|-57.0|-24.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-24.3|-57.0|<0.0001
91542355|NCT03903822|182964126|SUPERIORITY||LS Mean difference|3.9|STANDARD_ERROR_OF_MEAN|12.09||0.6269|TWO_SIDED|90.0|-16.1|23.9|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||23.9|-16.1|0.6269
91542356|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.87||0.0027|TWO_SIDED|90.0|-53.1|-13.8|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-13.8|-53.1|0.0027
91542357|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-38.8|STANDARD_ERROR_OF_MEAN|11.89||0.0007|TWO_SIDED|90.0|-58.5|-19.2|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.2|-58.5|0.0007
91542358|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-32.1|STANDARD_ERROR_OF_MEAN|12.0||0.0041|TWO_SIDED|90.0|-51.9|-12.3|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.9|0.0041
91542359|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-14.6|STANDARD_ERROR_OF_MEAN|11.61||0.1054|TWO_SIDED|90.0|-33.9|4.6|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||4.6|-33.9|0.1054
91542360|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-18.8|STANDARD_ERROR_OF_MEAN|11.62||0.0542|TWO_SIDED|90.0|-38.1|0.5|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.5|-38.1|0.0542
91542361|NCT03903822|182964126|SUPERIORITY||LS Mean difference|5.8|STANDARD_ERROR_OF_MEAN|12.12||0.6847|TWO_SIDED|90.0|-14.2|25.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||25.9|-14.2|0.6847
91542362|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-29.9|STANDARD_ERROR_OF_MEAN|11.82||0.0062|TWO_SIDED|90.0|-49.4|-10.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.3|-49.4|0.0062
91542363|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-32.0|STANDARD_ERROR_OF_MEAN|11.89||0.004|TWO_SIDED|90.0|-51.6|-12.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.6|0.0040
91542364|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-30.8|STANDARD_ERROR_OF_MEAN|11.97||0.0054|TWO_SIDED|90.0|-50.6|-11.0|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-11.0|-50.6|0.0054
91542365|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.35||0.1076|TWO_SIDED|90.0|-27.2|3.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.9|-27.2|0.1076
91542366|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-23.0|STANDARD_ERROR_OF_MEAN|9.42||0.0082|TWO_SIDED|90.0|-38.6|-7.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-7.3|-38.6|0.0082
91542367|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-17.8|STANDARD_ERROR_OF_MEAN|14.14||0.1051|TWO_SIDED|90.0|-41.2|5.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||5.6|-41.2|0.1051
91542368|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-37.8|STANDARD_ERROR_OF_MEAN|13.8||0.0034|TWO_SIDED|90.0|-60.6|-15.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.0|-60.6|0.0034
91542369|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-41.9|STANDARD_ERROR_OF_MEAN|13.83||0.0014|TWO_SIDED|90.0|-64.8|-19.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.0|-64.8|0.0014
91542370|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-38.6|STANDARD_ERROR_OF_MEAN|13.9||0.003|TWO_SIDED|90.0|-61.6|-15.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-61.6|0.0030
91542371|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-17.7|STANDARD_ERROR_OF_MEAN|9.22||0.0289|TWO_SIDED|90.0|-33.0|-2.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||-2.4|-33.0|0.0289
91542372|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-33.8|STANDARD_ERROR_OF_MEAN|9.27||0.0002|TWO_SIDED|90.0|-49.2|-18.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-18.4|-49.2|0.0002
91542373|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|13.88||0.4739|TWO_SIDED|90.0|-23.9|22.0|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||22.0|-23.9|0.4739
91542374|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-19.1|STANDARD_ERROR_OF_MEAN|13.43||0.0789|TWO_SIDED|90.0|-41.3|3.2|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.2|-41.3|0.0789
91542375|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-13.4|STANDARD_ERROR_OF_MEAN|13.5||0.1611|TWO_SIDED|90.0|-35.7|8.9|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||8.9|-35.7|0.1611
91542376|NCT03903822|182964126|SUPERIORITY||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|13.94||0.0124|TWO_SIDED|90.0|-54.7|-8.5|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-8.5|-54.7|0.0124
91542377|NCT03903822|182964126|SUPERIORITY||LS Mean difference|-5.3|STANDARD_ERROR_OF_MEAN|17.68||0.3828|TWO_SIDED|90.0|-34.7|24.1|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||24.1|-34.7|0.3828
91542378|NCT03903822|182964126|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|17.8||0.5383|TWO_SIDED|90.0|-27.9|31.3|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||31.3|-27.9|0.5383
91542379|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|-5.4||||0.8964|TWO_SIDED|90.0|-16.1|2.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||2.0|-16.1|0.8964
91542380|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|14.0||||0.0391|TWO_SIDED|90.0|1.0|28.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.2|1.0|0.0391
91542381|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-10.8|10.8|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||10.8|-10.8|1.0000
91542382|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|11.3||||0.0708|TWO_SIDED|90.0|-1.4|25.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.0|-1.4|0.0708
91542383|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|13.9||||0.0122|TWO_SIDED|90.0|4.7|27.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||27.0|4.7|0.0122
91542384|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|21.6||||0.0016|TWO_SIDED|90.0|11.0|35.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||35.6|11.0|0.0016
91542385|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|2.7||||0.395|TWO_SIDED|90.0|-9.8|16.1|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||16.1|-9.8|0.3950
91542386|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|19.7||||0.0173|TWO_SIDED|90.0|4.2|35.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||35.6|4.2|0.0173
91542387|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|16.2||||0.0327|TWO_SIDED|90.0|1.4|31.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||31.0|1.4|0.0327
91542388|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|30.8||||0.0011|TWO_SIDED|90.0|13.2|46.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||46.6|13.2|0.0011
91542389|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|11.1||||0.1348|TWO_SIDED|90.0|-5.0|27.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||27.2|-5.0|0.1348
91542390|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|18.5||||0.0328|TWO_SIDED|90.0|1.5|34.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||34.8|1.5|0.0328
91542391|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|10.8||||0.0769|TWO_SIDED|90.0|-1.8|24.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||24.4|-1.8|0.0769
91542392|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|30.7||||0.0005|TWO_SIDED|90.0|13.2|46.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||46.0|13.2|0.0005
91542393|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|37.8|||<|0.0001|TWO_SIDED|90.0|22.1|53.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||53.1|22.1|<0.0001
91542394|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|36.3||||0.0001|TWO_SIDED|90.0|19.7|51.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||51.8|19.7|0.0001
91542395|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-16.5|16.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||16.5|-16.5|1.0000
91542396|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|23.8||||0.0173|TWO_SIDED|90.0|4.5|41.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||41.5|4.5|0.0173
91542397|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5663|TWO_SIDED|90.0|-19.9|14.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||14.2|-19.9|0.5663
91542398|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|14.6||||0.1243|TWO_SIDED|90.0|-3.8|32.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||32.6|-3.8|0.1243
91542399|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|18.9||||0.046|TWO_SIDED|90.0|-0.5|36.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.6|-0.5|0.0460
91542400|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|25.7||||0.013|TWO_SIDED|90.0|4.8|43.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||43.3|4.8|0.0130
91542401|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|13.9||||0.1194|TWO_SIDED|90.0|-4.2|31.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||31.4|-4.2|0.1194
91542402|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|26.4||||0.0097|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||44.4|6.5|0.0097
91542403|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5556|TWO_SIDED|90.0|-21.0|16.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||16.1|-21.0|0.5556
91542404|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|17.6||||0.0761|TWO_SIDED|90.0|-2.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|-2.5|0.0761
91542405|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|18.9||||0.0583|TWO_SIDED|90.0|-0.8|37.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||37.6|-0.8|0.0583
91542406|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|14.9||||0.1245|TWO_SIDED|90.0|-5.0|33.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||33.7|-5.0|0.1245
91542407|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|19.4||||0.0382|TWO_SIDED|90.0|1.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|1.5|0.0382
91542408|NCT03903822|182964127|SUPERIORITY||Risk Difference (RD)|34.7||||0.0011|TWO_SIDED|90.0|13.2|51.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||51.4|13.2|0.0011
91542409|NCT00296036|182964148|SUPERIORITY_OR_OTHER|||||||0.768|||||||Fisher Exact|||||||0.768
91542410|NCT01796236|182964153|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||||||0.12
91542411|NCT01796236|182964154|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||"Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index \>=2. Any Overgrowth \>=2. Pain (scar/neuropathic) \>=3. Any numbness \>=2.~Each event is counted only once"||||0.45
91542412|NCT01796236|182964155|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney U test|||||||<0.0001
91542413|NCT01796236|182964156|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||Day 10||||0.020
91542414|NCT01796236|182964156|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Week 3||||0.4
91542415|NCT01796236|182964156|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 6||||1.00
91542416|NCT01796236|182964156|SUPERIORITY_OR_OTHER|||||||0.97|||||||Fisher Exact|||Week 12||||0.97
91542417|NCT01796236|182964156|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 24||||1.00
91542418|NCT01796236|182964157|SUPERIORITY_OR_OTHER|||||||0.4|||||||Mantel Haenszel|||Maximum of Holgers at 12 Months||||0.40
91542419|NCT01796236|182964157|SUPERIORITY_OR_OTHER|||||||0.14|||||||Mantel Haenszel|||Maximum of Holgers at 36 Months||||0.14
91542420|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mantel Haenszel|||Holgers Index Day 10||||0.38
91542421|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mantel Haenszel|||Holgers Index Week 3||||0.17
91542422|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Week 6||||0.37
91542423|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Week 12||||0.73
91542424|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.47|||||||Mantel Haenszel|||Holgers Index Week 24||||0.47
91542425|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Month 12||||0.73
91542426|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Month 24||||0.37
91542427|NCT01796236|182964158|SUPERIORITY_OR_OTHER|||||||0.75|||||||Mantel Haenszel|||Holgers Index Month 36||||0.75
91542428|NCT01796236|182964159|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 12 months||||<0.0001
91542429|NCT01796236|182964159|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 36 months||||<0.0001
91542430|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Day 10, Neuropathic pain||||0.74
91542431|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Day 10, Scar pain||||0.36
91542432|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Week 3, Neuropathic pain||||0.030
91542433|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Week 3, Scar pain||||0.92
91542434|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Week 6, Neuropathic pain||||0.15
91542435|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Week 6, Scar pain||||0.38
91542436|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Week 12, Neuropathic pain||||0.015
91542437|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12, Scar pain||||0.72
91542438|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Week 24, Neuropathic pain||||0.44
91542439|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24, Scar pain||||0.43
91542440|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12, Neuropathic pain||||0.21
91542441|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12, Scar pain||||0.97
91542442|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36, Neuropathic pain||||0.19
91542443|NCT01796236|182964160|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Month 36, Scar pain||||0.77
91542444|NCT01796236|182964161|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain||||0.076
91542445|NCT01796236|182964161|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mantel Haenszel|||Scar Categorical Max Pain||||0.49
91542446|NCT01796236|182964162|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain 36 months||||0.076
91542447|NCT01796236|182964162|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mantel Haenszel|||Scar Categorical Max Pain 36 months||||0.71
91542448|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|||Day 10: Neuropathic pain||||0.52
91542449|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Day 10: Scar pain||||0.44
91542450|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.14|||||||Cochran-Mantel-Haenszel|||Week 3: Neuropathic pain||||0.14
91542451|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.59|||||||Cochran-Mantel-Haenszel|||Week 3: Scar pain||||0.59
91542452|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.17|||||||Cochran-Mantel-Haenszel|||Week 6: Neuropathic pain||||0.17
91542453|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Week 6: Scar pain||||0.44
91542454|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Cochran-Mantel-Haenszel|||Week 12: Neuropathic pain||||0.0087
91542455|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.84|||||||Cochran-Mantel-Haenszel|||Week 12: Scar pain||||0.84
91542456|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.43|||||||Cochran-Mantel-Haenszel|||Week 24: Neuropathic pain||||0.43
91542457|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.33|||||||Cochran-Mantel-Haenszel|||Week 24: Scar pain||||0.33
91542458|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.21|||||||Cochran-Mantel-Haenszel|||Month 12 Neuropathic pain||||0.21
91542459|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Month 12 Scar pain||||0.82
91542460|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|||Month 36 Neuropathic pain||||0.19
91542461|NCT01796236|182964163|SUPERIORITY_OR_OTHER|||||||0.77|||||||Cochran-Mantel-Haenszel|||Month 36 Scar pain||||0.77
91542462|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||Day 10 Soft tissue thickening/overgrowth||||0.12
91542463|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mantel Haenszel|||Week 3 Soft tissue thickening/overgrowth||||0.016
91542464|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mantel Haenszel|||Week 6 Soft tissue thickening/overgrowth||||0.84
91542465|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.53|||||||Mantel Haenszel|||Week 12 Soft tissue thickening/overgrowth||||0.53
91542466|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mantel Haenszel|||Week 24 Soft tissue thickening/overgrowth||||0.18
91542467|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mantel Haenszel|||Month 12 Soft tissue thickening/overgrowth||||0.63
91542468|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mantel Haenszel|||Month 24 Soft tissue thickening/overgrowth||||0.81
91542469|NCT01796236|182964164|SUPERIORITY_OR_OTHER|||||||1|||||||Mantel Haenszel|||Month 36 Soft tissue thickening/overgrowth||||1.00
91542470|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Day 10||||0.0009
91542471|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 3||||0.0080
91542472|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 6||||0.46
91542473|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 12||||0.45
91542474|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 24||||0.18
91542475|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 12||||0.017
91542476|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 24||||0.15
91542477|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 36||||0.32
91542478|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.74|||||||Sign test|||Change in Visible Test Abutment - Week 3 change from day 10||||0.74
91542479|NCT01796236|182964165|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Test Abutment - Week 6 change from day 10||||<0.0001
91542480|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.041|||||||Sign test|||Change in Visible Test Abutment - Week 12 change from day 10||||0.041
91542481|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Sign test|||Change in Visible Test Abutment - Week 24 change from day 10||||0.0065
91542482|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Sign test|||Change in Visible Test Abutment - Month 12 change from day 10||||0.0003
91542483|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.028|||||||Sign test|||Change in Visible Test Abutment - Month 24 change from day 10||||0.028
91542484|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.037|||||||Sign test|||Change in Visible Test Abutment - Month 36 change from day 10||||0.037
91542485|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.072|||||||Sign test|||Change in Visible Control Abutment - Week 3 change from day 10||||0.072
91542486|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.034|||||||Sign test|||Change in Visible Control Abutment - Week 6 change from day 10||||0.034
91542487|NCT01796236|182964165|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Control Abutment - Week 12 change from day 10||||<0.0001
91542488|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.01|||||||Sign test|||Change in Visible Control Abutment - Week 24 change from day 10||||0.010
91542489|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.0086|||||||Sign test|||Change in Visible Control Abutment - Month 12 change from day 10||||0.0086
91542490|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Sign test|||Change in Visible Control Abutment - Month 24 change from day 10||||0.0021
91542491|NCT01796236|182964165|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Sign test|||Change in Visible Control Abutment - Month 36 change from day 10||||0.0005
91542492|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||Week 12: Vascularity (observer)||||0.026
91542493|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vascularity (observer)||||0.33
91542494|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vascularity (observer)||||0.094
91542495|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pigmentation (observer)||||0.30
91542496|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pigmentation (observer)||||0.23
91542497|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pigmentation (observer)||||0.48
91542498|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (observer)||||0.0003
91542499|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (observer)||||0.062
91542500|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (observer)||||0.11
91542501|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Relief (observer)||||0.0003
91542502|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 12: Relief (observer)||||0.079
91542503|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Month 36: Relief (observer)||||0.025
91542504|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pliability (observer)||||0.0020
91542505|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pliability (observer)||||0.14
91542506|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pliability (observer)||||0.0014
91542507|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 12: Surface Area (observer)||||0.0001
91542508|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Month 12: Surface Area (observer)||||0.023
91542509|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||Month 36: Surface Area (observer)||||0.045
91542510|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (observer)||||0.0005
91542511|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (observer)||||0.085
91542512|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (observer)||||0.030
91542513|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (observer)||||0.0015
91542514|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Month 12: Overall Opinion (observer)||||0.076
91542515|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (observer)||||0.15
91542516|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12: Painful (patient)||||0.72
91542517|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12: Painful (patient)||||0.97
91542518|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 36: Painful (patient)||||0.82
91542519|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Week 12: Itching (patient)||||0.86
91542520|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 12: Itching (patient)||||0.84
91542521|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Itching (patient)||||0.76
91542522|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 12: Color (patient)||||0.41
91542523|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Month 12: Color (patient)||||0.98
91542524|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Color (patient)||||0.76
91542525|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 12: Stiffness (patient)||||0.43
91542526|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 12: Stiffness (patient)||||0.25
91542527|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Month 36: Stiffness (patient)||||0.017
91542528|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (patient)||||0.13
91542529|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (patient)||||0.33
91542530|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (patient)||||0.65
91542531|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Week 12: Irregularity (patient)||||0.18
91542532|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Irregularity (patient)||||0.38
91542533|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Month 36: Irregularity (patient)||||0.080
91542534|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (patient)||||0.28
91542535|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (patient)||||0.44
91542536|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (patient)||||0.19
91542537|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.16
91542538|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.23
91542539|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (patient)||||0.079
91542540|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pain not within Scar (patient)||||0.0018
91542541|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain not within Scar (patient)||||0.053
91542542|NCT01796236|182964166|SUPERIORITY_OR_OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain not within Scar (patient)||||0.068
91542543|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI3)||||0.90
91542544|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI3)||||0.43
91542545|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI3)||||0.23
91542546|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI3)||||0.019
91542547|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Baseline: Vision (HUI3)||||0.079
91542548|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Vision (HUI3)||||0.96
91542549|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vision (HUI3)||||0.55
91542550|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vision (HUI3)||||0.64
91542551|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Baseline: Hearing (HUI3)||||0.76
91542552|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||Week 24: Hearing (HUI3)||||0.059
91542553|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Hearing (HUI3)||||0.38
91542554|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Hearing (HUI3)||||0.14
91542555|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Baseline: Speech (HUI3)||||0.73
91542556|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Week 24: Speech (HUI3)||||0.65
91542557|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Month 12: Speech (HUI3)||||1.00
91542558|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Month 36: Speech (HUI3)||||0.35
91542559|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ambulation (HUI3)||||0.50
91542560|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ambulation (HUI3)||||0.40
91542561|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ambulation (HUI3)||||0.21
91542562|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ambulation (HUI3)||||0.0010
91542563|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI3)||||0.13
91542564|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI3)||||0.96
91542565|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI3)||||0.75
91542566|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI3)||||0.20
91542567|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI3)||||0.95
91542568|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI3)||||0.31
91542569|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI3)||||0.15
91542570|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI3)||||0.19
91542571|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI3)||||0.41
91542572|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI3)||||0.30
91542573|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI3)||||0.42
91542574|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI3)||||0.040
91542575|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI2)||||0.99
91542576|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI2)||||0.88
91542577|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI2)||||0.32
91542578|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.0084|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI2)||||0.0084
91542579|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Baseline: Sensation (HUI2)||||0.77
91542580|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Week 24: Sensation (HUI2)||||0.95
91542581|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Month 12: Sensation (HUI2)||||0.60
91542582|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Sensation (HUI2)||||0.48
91542583|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Baseline: Mobility (HUI2)||||0.51
91542584|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Week 24: Mobility (HUI2)||||0.42
91542585|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Month 12: Mobility (HUI2)||||0.22
91542586|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Month 36: Mobility (HUI2)||||0.0018
91542587|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI2)||||0.30
91542588|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI2)||||0.52
91542589|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI2)||||0.47
91542590|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI2)||||0.18
91542591|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI2)||||0.82
91542592|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI2)||||0.41
91542593|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI2)||||0.14
91542594|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI2)||||0.25
91542595|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline: Self Care (HUI2)||||0.59
91542596|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Week 24: Self Care (HUI2)||||1.00
91542597|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Self Care (HUI2)||||0.55
91542598|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Self Care (HUI2)||||0.14
91542599|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI2)||||0.75
91542600|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI2)||||0.63
91542601|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI2)||||0.57
91542602|NCT01796236|182964167|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI2)||||0.019
91542603|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Aided)||||0.047
91542604|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Aided)||||0.23
91542605|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Aided)||||0.015
91542606|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Aided)||||0.13
91542607|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Aided)||||0.041
91542608|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Unaided)||||0.071
91542609|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Unaided)||||0.75
91542610|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Unaided)||||0.32
91542611|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Unaided)||||0.24
91542612|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Unaided)||||0.24
91542613|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Benefit)||||0.12
91542614|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Benefit)||||0.19
91542615|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Benefit)||||0.055
91542616|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Benefit)||||0.24
91542617|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Benefit)||||0.042
91542618|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Aided)||||0.19
91542619|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Aided)||||0.99
91542620|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Aided)||||0.24
91542621|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Aided)||||0.73
91542622|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Aided)||||0.39
91542623|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Unaided)||||0.24
91542624|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Unaided)||||0.81
91542625|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Unaided)||||0.34
91542626|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Unaided)||||0.038
91542627|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Unaided)||||0.53
91542628|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Benefit)||||0.63
91542629|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Benefit)||||0.83
91542630|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Benefit)||||0.71
91542631|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Benefit)||||0.16
91763916|NCT00286429|183418394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.674|||<|0.001|TWO_SIDED|95.0|1.579|4.53||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.530|1.579|<0.001
91542632|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Benefit)||||0.81
91542633|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Aided)||||0.51
91542634|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Aided)||||0.47
91542635|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Aided)||||0.93
91542636|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Aided)||||0.62
91542637|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Aided)||||0.63
91542638|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Unaided)||||0.18
91542639|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Unaided)||||0.76
91542640|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Unaided)||||0.17
91542641|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Unaided)||||0.29
91542642|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Unaided)||||0.40
91542643|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Benefit)||||0.29
91542644|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Benefit)||||0.90
91542645|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Benefit)||||0.24
91542646|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Benefit)||||0.45
91542647|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Benefit)||||0.37
91542648|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Aided)||||0.84
91542649|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Aided)||||0.57
91542650|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Aided)||||0.71
91542651|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Aided)||||0.99
91542652|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Aided)||||0.78
91542653|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Unaided)||||0.50
91542654|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Unaided)||||0.48
91542655|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Unaided)||||0.64
91542656|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Unaided)||||0.041
91542657|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Unaided)||||0.89
91542658|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Benefit)||||0.14
91542659|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Benefit)||||0.48
91542660|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Benefit)||||0.23
91542661|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Benefit)||||0.57
91542662|NCT01796236|182964168|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Benefit)||||0.21
91542663|NCT01796236|182964169|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Sound Processor Usage: Week 6||||0.46
91542664|NCT01796236|182964169|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 12||||0.75
91542665|NCT01796236|182964169|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 24||||0.83
91542666|NCT01796236|182964169|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 12||||0.52
91542667|NCT01796236|182964169|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 24||||0.67
91542668|NCT01796236|182964169|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 36||||0.71
91542669|NCT01796236|182964171|SUPERIORITY_OR_OTHER|||||||0.91|||||||Mantel Haenszel|||Baseline: Smoking and Wet Snuff habits||||0.91
91542670|NCT01796236|182964171|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mantel Haenszel|||Week 3: Smoking and Wet Snuff habits||||0.70
91542671|NCT01796236|182964171|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mantel Haenszel|||Week 12: Smoking and Wet Snuff habits||||0.95
91542672|NCT01796236|182964171|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mantel Haenszel|||Month 12: Smoking and Wet Snuff habits||||0.22
91542673|NCT01796236|182964171|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mantel Haenszel|||Month 24: Smoking and Wet Snuff habits||||0.19
91542674|NCT01796236|182964171|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||Month 36: Smoking and Wet Snuff habits||||0.45
91542675|NCT01796236|182964172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.989|TWO_SIDED|95.0|||||Log Rank|||Loss of Implant (safety population)||||0.989
91542676|NCT03811574|182964176|SUPERIORITY||Treatment difference|-7.52|||<|0.0001|TWO_SIDED|95.0|-9.62|-5.43|||ANCOVA|||Treatment policy estimand||-5.43|-9.62|<.0001
91542677|NCT03811574|182964176|SUPERIORITY||Treatment difference|-11.06|||<|0.0001|TWO_SIDED|95.0|-12.88|-9.24|||ANCOVA|||Treatment policy estimand||-9.24|-12.88|<.0001
91542678|NCT03811574|182964177|SUPERIORITY||Odds Ratio (OR)|11.08|||<|0.0001|TWO_SIDED|95.0|5.53|22.22|||Regression, Logistic|||Treatment policy estimand||22.22|5.53|<.0001
91542679|NCT03811574|182964177|SUPERIORITY||Odds Ratio (OR)|21.72|||<|0.0001|TWO_SIDED|95.0|11.27|41.86|||Regression, Logistic|||Treatment policy estimand||41.86|11.27|<.0001
91542680|NCT06243796|182964215|SUPERIORITY||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
91763917|NCT00286429|183418394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.819|||<|0.001|TWO_SIDED|95.0|1.653|4.808||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.808|1.653|<0.001
91542681|NCT06243796|182964216|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91542682|NCT01395758|182964264|SUPERIORITY|||||||0.5017|||||||Log Rank|||||||0.5017
91542683|NCT01395758|182964265|SUPERIORITY|||||||0.4356|||||||Log Rank|||||||0.4356
91542684|NCT03631550|182964278|SUPERIORITY|||||||0.018|||||||Chi-squared|||||||0.018
91542685|NCT03631550|182964279|SUPERIORITY|||||||0.0466|||||||Chi-squared|||||||0.0466
91542686|NCT03631550|182964280|SUPERIORITY|||||||0.0677|||||||Chi-squared|||||||0.0677
91542687|NCT03631550|182964281|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
91542688|NCT03631550|182964282|OTHER|||||||0.0968|||||||Fisher Exact|||||||0.0968
91542689|NCT03631550|182964283|SUPERIORITY|||||||0.0121|||||||ANCOVA|||||||0.0121
91542690|NCT04515641|182964290|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.96|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.96|0.58|
91542691|NCT04515641|182964291|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.98|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.98|0.58|
91542692|NCT04515641|182964292|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.38|1.14|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.38|
91542693|NCT04515641|182964299|OTHER||GMR|0.76|||||TWO_SIDED|90.0|0.57|1.0|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.00|0.57|
91542694|NCT04515641|182964300|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.58|1.03|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.03|0.58|
91542695|NCT04515641|182964301|OTHER||GMR|0.96|||||TWO_SIDED|90.0|0.63|1.46|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.46|0.63|
91542696|NCT04515641|182964302|OTHER||GMR|1.05|||||TWO_SIDED|90.0|0.65|1.71|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.71|0.65|
91542697|NCT04515641|182964303|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.59|1.26|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.26|0.59|
91542698|NCT04515641|182964304|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.42|1.01|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.01|0.42|
91542699|NCT01415349|182964309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.966|1.09|||Mixed Models Analysis|||||1.09|0.966|
91542700|NCT01415349|182964310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.998|1.08|||Mixed Models Analysis|||||1.08|0.998|
91542701|NCT02918071|182964337|OTHER||percentage|97.4|||||TWO_SIDED|95.0|92.63|99.46|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients successfully administered benralizumab with an AI at home (Week 12)|||99.46|92.63|
91542702|NCT02918071|182964337|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.41|99.05|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)|||99.05|91.41|
91542703|NCT02918071|182964337|OTHER||Percentage|93.1|||||TWO_SIDED|95.0|86.86|96.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)|||96.98|86.86|
91542704|NCT02918071|182964338|OTHER||Percentage|97.4|||||TWO_SIDED|95.0|92.69|99.47|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional AI administered at home (Week 12)|||99.47|92.69|
91542705|NCT02918071|182964338|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.48|99.06|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional AI administered at home (Week 16)|||99.06|91.48|
91542706|NCT02918071|182964339|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.0|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)|||3.00|0.00|
91542707|NCT02918071|182964339|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)|||4.52|0.02|
91542708|NCT02918071|182964339|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)|||4.59|0.02|
91542709|NCT02918071|182964339|OTHER||Percentage|2.6|||||TWO_SIDED|95.0|0.53|7.31|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)|||7.31|0.53|
91542710|NCT02918071|182964339|OTHER||Percentage|3.4|||||TWO_SIDED|95.0|0.94|8.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)|||8.52|0.94|
91542711|NCT02918071|182964339|OTHER||Percentage|0.6|||||TWO_SIDED|95.0|0.07|1.99|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)|||1.99|0.07|
91542712|NCT02918071|182964339|OTHER||Percentage|3.0|||||TWO_SIDED|95.0|1.21|6.07|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)|||6.07|1.21|
91542713|NCT02918071|182964339|OTHER||Percentage|1.5|||||TWO_SIDED|95.0|0.69|2.85|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)|||2.85|0.69|
91542714|NCT06336629|182964356|SUPERIORITY||two-sided|100.0|||||TWO_SIDED|95.0||||||||||||
91542715|NCT06336629|182964357|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91542716|NCT06336629|182964358|SUPERIORITY|||||||0.007|||||||Wilcoxon rank-sum test|||||||0.007
91542717|NCT06336629|182964359|SUPERIORITY|||||||0.009|||||||Wilcoxon rank sum test|||||||0.009
91542718|NCT06336629|182964360|SUPERIORITY|||||||0.037||||||P-value from Baseline at Week 16|Wilcoxon signed rank|P-value from Baseline at Week 16||||||0.037
91542719|NCT06336629|182964362|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
91542720|NCT06336629|182964363|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
91542721|NCT04043455|182964372|SUPERIORITY||Least square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.407|=|0.65|TWO_SIDED|95.0|-0.99|0.62|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% confidence interval (CI) has been presented.||0.62|-0.99|=0.650
91542722|NCT04043455|182964372|SUPERIORITY||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.409|=|0.439|TWO_SIDED|95.0|-1.12|0.49|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.49|-1.12|=0.439
91542723|NCT04043455|182964372|SUPERIORITY||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.401|=|0.172|TWO_SIDED|95.0|-1.34|0.24|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.24|-1.34|=0.172
91542724|NCT04043455|182964379|SUPERIORITY||Odds Ratio (OR)|1.156||||0.659|TWO_SIDED|95.0|-0.019|2.331|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odds ratio and 95% CI has been presented.||2.331|-0.019|0.659
91542725|NCT04043455|182964379|SUPERIORITY||Odds Ratio (OR)|1.248||||0.557|TWO_SIDED|95.0|-0.04|2.535|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odds ratio and 95% CI has been presented.||2.535|-0.040|0.557
91542726|NCT04043455|182964379|SUPERIORITY||Odds Ratio (OR)|1.245||||0.541|TWO_SIDED|95.0|0.027|2.462|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odds ratio and 95% CI has been presented.||2.462|0.027|0.541
91542727|NCT04043455|182964380|SUPERIORITY||Odds Ratio (OR)|1.234||||0.529|TWO_SIDED|95.0|-0.001|2.468|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odd's ratio and 95% CI has been presented.||2.468|-0.001|0.529
91542728|NCT04043455|182964380|SUPERIORITY||Odds Ratio (OR)|1.123||||0.73|TWO_SIDED|95.0|0.015|2.232|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odd's ratio and 95% CI has been presented.||2.232|0.015|0.730
91542729|NCT04043455|182964380|SUPERIORITY||Odds Ratio (OR)|1.226||||0.548|TWO_SIDED|95.0|0.025|2.428|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odd's ratio and 95% CI has been presented.||2.428|0.025|0.548
91542730|NCT04043455|182964381|SUPERIORITY||Least square mean difference|-2.42|STANDARD_ERROR_OF_MEAN|6.189||0.696|TWO_SIDED|95.0|-14.61|9.76|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||9.76|-14.61|0.696
91542731|NCT04043455|182964381|SUPERIORITY||Least square mean difference|-3.25|STANDARD_ERROR_OF_MEAN|6.222||0.602|TWO_SIDED|95.0|-15.51|9.0|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||9.00|-15.51|0.602
91542732|NCT04043455|182964381|SUPERIORITY||Least square mean difference|-3.96|STANDARD_ERROR_OF_MEAN|6.088||0.516|TWO_SIDED|95.0|-15.95|8.03|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||8.03|-15.95|0.516
91542733|NCT04043455|182964382|SUPERIORITY||Least square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.305||0.804|TWO_SIDED|95.0|-0.53|0.68|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||0.68|-0.53|0.804
91542734|NCT04043455|182964382|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.308||0.618|TWO_SIDED|95.0|-0.76|0.45|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.45|-0.76|0.618
91542735|NCT04043455|182964382|SUPERIORITY||Least square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.301||0.687|TWO_SIDED|95.0|-0.47|0.71|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.71|-0.47|0.687
91542736|NCT03422276|182964386|SUPERIORITY||Mean Difference (Net)|-0.78||||0.44|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|t-test for independent samples, two-tailed, allocation ratio=1|Intervention mean minus control mean|It was calculated that 500 to 900 participants randomized in a 1:1 fashion between the two arms would have practically 100% power to detect an effect size of 0.5, and even a small sample size of 300 would have 80% power to detect a small effect size of 0.3 (800 to 900 would be 100% power).||||0.44
91542737|NCT03422276|182964387|SUPERIORITY||Mean Difference (Net)|1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
91542738|NCT04922021|182964400|SUPERIORITY|Two-sided hypotheses were tested based on the pre-specified primary analysis for the primary estimand. The primary estimand used a hypothetical strategy evaluating the treatment difference as if all subjects adhered to the treatment regimen, i.e. they did not discontinue IMP permanently, did not initiate rescue treatment, or did not have more than one missed treatment dose related to COVID-19.|Mean Difference (Net)|-11.8||||0.003|TWO_SIDED|95.0|-19.6|-4.1||The type I error rate of the two-sided hypothesis test was controlled at the 5% significance level.|ANCOVA|ANCOVA model: Change in EASI = Treatment + Region + Baseline EASI. Missing values and data 'treated as missing' were imputed using MI assuming MAR.|Estimates of difference in LS-means and associated standard errors from the analyses were combined using Rubin's rule to provide the overall pooled estimate and associated standard error. LS-means was estimated using the observed margins for the FAS.|||-4.1|-19.6|0.003
91542739|NCT01998984|182964424|SUPERIORITY||Relative risk|2.97||||0.18|TWO_SIDED|95.0|0.6|14.74||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group."||14.74|0.60|0.18
91542740|NCT01998984|182964424|SUPERIORITY||Relative risk|3.51||||0.051|TWO_SIDED|95.0|1.0|12.41||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.~Type I error not controlled."||12.41|1.00|0.051
91542741|NCT01998984|182964424|SUPERIORITY||Relative risk|0.47||||0.25|TWO_SIDED|95.0|0.13|1.68||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Mantel Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Type I error not controlled. Mantel-Haenszel estimators were used."||1.68|0.13|0.25
91542742|NCT01998984|182964425|SUPERIORITY||Ratio of adjusted mean|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.51||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.51|0.32|<0.001
91542743|NCT01998984|182964425|SUPERIORITY||Ratio of adjusted mean|0.36|||<|0.001|TWO_SIDED|95.0|0.29|0.45||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.45|0.29|<0.001
91542744|NCT01998984|182964425|SUPERIORITY||Ratio of adjusted mean|0.89||||0.36|TWO_SIDED|95.0|0.7|1.14||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||1.14|0.70|0.36
91542745|NCT01998984|182964426|SUPERIORITY||Relative risk|32.26|||<|0.001|TWO_SIDED|95.0|4.39|236.8||P value adjusted for analysis site.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||236.8|4.39|<0.001
91542746|NCT01998984|182964426|SUPERIORITY||Relative risk|25.2||||0.002|TWO_SIDED|95.0|3.39|187.4||Adjusted for analysis site. Relative risk of partial clearance relative to vehicle group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||187.4|3.39|0.002
91542747|NCT01998984|182964426|SUPERIORITY||Relative risk|1.2||||0.28|TWO_SIDED|95.0|0.86|1.65||Adjusted for analysis site. Relative risk of partial clearance relative to 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||1.65|0.86|0.28
91542748|NCT02652260|182964427|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|4.65||||0.331|TWO_SIDED|95.0|-15.92|24.85|||Miettinen and Nurminen|||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.|24.85|-15.92|0.331
91542749|NCT02652260|182964428|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|-18.61|||||TWO_SIDED|95.0|-38.14|2.51||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|2.51|-38.14|
91542750|NCT02652260|182964429|OTHER||Estimated Difference|-2.0|||||TWO_SIDED|95.0|-10.5|6.5||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was based on a t-distribution.|6.5|-10.5|
91542751|NCT02652260|182964430|OTHER||Estimated Difference|3.6|||||TWO_SIDED|95.0|-4.1|11.3||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|11.3|-4.1|
91542752|NCT02652260|182964431|OTHER|The 95% CI was calculated by the method of Miettinen and Nurminen.|Difference in Percentage|-38.4|||||TWO_SIDED|95.0|-51.2|-23.8||||||Change from time of switch to 24 weeks post-switch: Treatment difference in percent response|Week 24 Post-switch minus Time of switch|-23.8|-51.2|
91542753|NCT02652260|182964432|OTHER|The 95% CI was based on a t-distribution.|Mean Difference (Final Values)|-13.4|||||TWO_SIDED|95.0|-16.8|-10.1||||||Change from time of switch to 24 weeks post-switch: Treatment difference in score|Week 24 Post-switch minus Time of switch|-10.1|-16.8|
91542754|NCT02652260|182964433|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-9.02|||||TWO_SIDED|95.0|-15.69|-2.35||||||Difference Estimate: LDL Cholesterol|ISG minus DSG|-2.35|-15.69|
91542755|NCT02652260|182964433|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-13.57|||||TWO_SIDED|95.0|-20.79|-6.35||||||Difference Estimate: Non-HDL Cholesterol|ISG minus DSG|-6.35|-20.79|
91542756|NCT02652260|182964433|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-21.42|||||TWO_SIDED|95.0|-29.63|-13.21||||||Difference Estimate: Cholesterol|ISG minus DSG|-13.21|-29.63|
91542757|NCT02652260|182964433|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-8.18|||||TWO_SIDED|95.0|-11.76|-4.6||||||Difference Estimate: HDL Cholesterol|ISG minus DSG|-4.60|-11.76|
91542758|NCT02652260|182964433|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-22.18|||||TWO_SIDED|95.0|-38.52|-5.84||||||Difference Estimate: Triglyceride|ISG minus DSG|-5.84|-38.52|
91542759|NCT01631214|182964585|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.36|0.64|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.36|<0.001
91542760|NCT01631214|182964585|SUPERIORITY||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.38|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.38|
91542761|NCT01631214|182964585|SUPERIORITY||Absolute risk reduction|4.03|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|2.5|5.57||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||5.57|2.50|
91542762|NCT01631214|182964586|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.61|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)|||0.88|0.61|<0.001
91542763|NCT01631214|182964587|SUPERIORITY|If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|95.0|0.66|0.99||The adjusted 2-sided p-value is reported.|Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.99|0.66|0.040
91542764|NCT01631214|182964588|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.65|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.56|0.76|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.76|0.56|<0.001
91542765|NCT01631214|182964589|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.49|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.37|0.64|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.37|<0.001
91542766|NCT01631214|182964589|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.4|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.40|
91542767|NCT01631214|182964589|SUPERIORITY||Absolute risk reduction|4.44|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|2.8|6.08||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||6.08|2.80|
91542768|NCT01631214|182964590|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.11||0.004|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.90|0.59|0.004
91542769|NCT01631214|182964591|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.2||0.015|TWO_SIDED|95.0|0.42|0.92|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.92|0.42|0.015
91542770|NCT01631214|182964592|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.25||0.008|TWO_SIDED|95.0|0.31|0.85|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.85|0.31|0.008
91542771|NCT01631214|182964592|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.32|0.85|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.85|0.32|
91542772|NCT01631214|182964592|SUPERIORITY||Absolute risk reduction|1.21|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.33|2.1||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||2.10|0.33|
91542773|NCT01631214|182964593|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.005|TWO_SIDED|95.0|0.59|0.91|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.91|0.59|0.005
91542774|NCT01631214|182964594|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.12||0.074|TWO_SIDED|95.0|0.64|1.02|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.02|0.64|0.074
91542775|NCT01631214|182964595|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.24||0.17|TWO_SIDED|95.0|0.46|1.15|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.15|0.46|0.17
91542776|NCT01631214|182964596|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.41|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|0.24|0.71|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.71|0.24|<0.001
91542777|NCT01631214|182964597|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.54|0.96|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.96|0.54|0.027
91542778|NCT01631214|182964598|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|0.44|0.89|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.89|0.44|0.008
91542779|NCT01631214|182964598|SUPERIORITY||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.46|0.89|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.89|0.46|
91542780|NCT01631214|182964598|SUPERIORITY||Absolute risk reduction|1.84|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.51|3.17||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||3.17|0.51|
91542781|NCT01631214|182964599|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.71|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|0.57|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.88|0.57|0.002
91542782|NCT01631214|182964600|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.16||0.057|TWO_SIDED|95.0|0.54|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.54|0.057
91542783|NCT01631214|182964601|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|0.33|1.26|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.26|0.33|0.19
91542784|NCT01631214|182964602|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.17||0.053|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.52|0.053
91542785|NCT01631214|182964603|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.56|STANDARD_ERROR_OF_MEAN|0.39||0.14|TWO_SIDED|95.0|0.26|1.22|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.22|0.26|0.14
91542786|NCT01631214|182964604|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|7.58|8.57|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an analysis of covariance (ANCOVA) model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||8.57|7.58|<0.001
91542787|NCT01631214|182964605|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.42|4.1|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.10|3.42|<0.001
91542788|NCT01631214|182964606|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.4|4.14|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.14|3.40|<0.001
91542789|NCT01631214|182964607|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|8.31|9.09|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||9.09|8.31|<0.001
91542790|NCT01631214|182964608|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|3.03|3.6|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.60|3.03|<0.001
91542791|NCT01631214|182964609|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|2.9|3.54|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.54|2.90|<0.001
91763918|NCT00286429|183418395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.163|||<|0.001|TWO_SIDED|95.0|1.651|6.06||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||6.060|1.651|<0.001
91763919|NCT00286429|183418395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.989|||<|0.001|TWO_SIDED|95.0|2.083|7.64||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||7.640|2.083|<0.001
91542792|NCT01631214|182964610|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.84|7.89|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||7.89|6.84|<0.001
91542793|NCT01631214|182964611|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.29|4.02|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.02|3.29|<0.001
91542794|NCT01631214|182964612|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.18|3.97|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.97|3.18|<0.001
91542795|NCT01622868|182964625|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||The study was designed to see if there is a signal in the 12-week CR rate with the addition of lapatinib to warrant a future phase III trial. Null hypothesis: the 12-week post-WBRT/SRS CR rate is ≤ 5%; alternative hypothesis: the addition of lapatinib will increase that CR rate to at least 20%. 114 eligible participants provide 86% power to detect a 15% absolute increase in CR rate at a significance level of 0.10, using a 1-sided Z-test for the difference of 2 proportions.||||0.97
91542796|NCT01622868|182964626|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||||||0.78
91542797|NCT01622868|182964627|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||4 weeks post-RT||||0.78
91542798|NCT01622868|182964627|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||12 weeks post-RT||||0.97
91542799|NCT01622868|182964633|SUPERIORITY|||||||1||||||One-sided significance level = 0.10|z-test|||||||1.00
91542800|NCT01622868|182964635|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.67|TWO_SIDED|95.0|0.62|1.36||Two-sided significance level = 0.05|Log Rank|||||1.36|0.62|0.67
91542801|NCT03112174|182964682|SUPERIORITY||Hazard Ratio (HR)|0.629||||0.0024|TWO_SIDED|95.0|0.465|0.85||P value is from stratified log-rank test.|Log Rank|||||0.850|0.465|0.0024
91542802|NCT03112174|182964688|SUPERIORITY||Rate Ratio|1.658||||0.0004|TWO_SIDED|95.0|1.24|2.218||Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||2.218|1.240|0.0004
91542803|NCT03112174|182964689|SUPERIORITY||Rate Ratio|1.101||||0.1279|TWO_SIDED|95.0|0.973|1.247||Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||1.247|0.973|0.1279
91542804|NCT03112174|182964690|SUPERIORITY|||||||0.2028|||||||Fisher Exact|||Bone marrow aspirate||||0.2028
91542805|NCT03112174|182964690|SUPERIORITY|||||||0.0014|||||||Fisher Exact|||Peripheral blood||||0.0014
91542806|NCT03112174|182964691|SUPERIORITY||Hazard Ratio (HR)|0.832||||0.2669|TWO_SIDED|95.0|0.602|1.151||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||1.151|0.602|0.2669
91542807|NCT03112174|182964693|SUPERIORITY||Hazard Ratio (HR)|0.541||||0.0013|TWO_SIDED|95.0|0.369|0.792||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||0.792|0.369|0.0013
91542808|NCT03112174|182964708|SUPERIORITY||Hazard Ratio (HR)|1.169||||0.2861|TWO_SIDED|95.0|0.879|1.554||P value is from stratified log-rank test.|Log Rank|||||1.554|0.879|0.2861
91542809|NCT04425629|182964714|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.1|=|0.0006|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|= 0.0006
91542810|NCT04425629|182964714|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||||-0.19|-0.56|< 0.0001
91542811|NCT04425629|182964715|SUPERIORITY||||||=|0.0024|||||||Cochran-Mantel-Haenszel|||||||= 0.0024
91542812|NCT04425629|182964716|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
91542813|NCT04425629|182964722|SUPERIORITY||||||=|0.1903|||||||Mixed Models Analysis|||||||= 0.1903
91542814|NCT04425629|182964722|SUPERIORITY||||||=|0.8431|||||||Mixed Models Analysis|||||||= 0.8431
91542815|NCT04425629|182964778|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.06|16.12||||||||16.12|0.06|
91542816|NCT04425629|182964779|SUPERIORITY||Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.03|3.13||||||||3.13|0.03|
91542817|NCT03538717|182964865|SUPERIORITY|||||||0.113|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.113
91542818|NCT03538717|182964866|SUPERIORITY|||||||0.228|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.228
91542819|NCT03538717|182964867|SUPERIORITY|||||||0.02|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.020
91542820|NCT03538717|182964868|SUPERIORITY|||||||0.138|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.138
91542821|NCT03538717|182964869|SUPERIORITY|||||||0.524|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.524
91542822|NCT03538717|182964870|SUPERIORITY|||||||0.265|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.265
91542823|NCT03538717|182964871|SUPERIORITY|||||||0.035|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.035
91542824|NCT03538717|182964872|SUPERIORITY|||||||0.123|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.123
91542825|NCT03538717|182964873|SUPERIORITY|||||||0.327|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.327
91542826|NCT03538717|182964874|SUPERIORITY|||||||0.419|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.419
91542827|NCT03538717|182964875|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.010
91542828|NCT03538717|182964876|SUPERIORITY|||||||0.446|||||||Chi-squared|||100% clear cells||||0.446
91542829|NCT03538717|182964876|SUPERIORITY|||||||0.596|||||||Chi-squared|||100% non-clear cells||||0.596
91542830|NCT03538717|182964876|SUPERIORITY|||||||0.578|||||||Chi-squared|||Majority component of clear cells||||0.578
91542831|NCT03538717|182964876|SUPERIORITY|||||||0.706|||||||Fisher Exact|||Majority component of non-clear cells||||0.706
91542832|NCT03538717|182964877|SUPERIORITY|||||||0.074|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.074
91542833|NCT03538717|182964878|SUPERIORITY|||||||0.07|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.070
91542834|NCT03538717|182964879|SUPERIORITY|||||||0.091|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.091
91542835|NCT03538717|182964880|SUPERIORITY|||||||0.046|||||||Chi-squared|||Lymph nodes||||0.046
91542836|NCT03538717|182964880|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||CNS||||>0.999
91542837|NCT03538717|182964880|SUPERIORITY|||||||0.026|||||||Chi-squared|||Hepatic||||0.026
91542838|NCT03538717|182964880|SUPERIORITY|||||||0.327|||||||Chi-squared|||Pulmonary||||0.327
91763920|NCT00286429|183418396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55||||0.002|TWO_SIDED|95.0|1.732|11.953||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||11.953|1.732|0.002
91763921|NCT00286429|183418396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.74|12.052||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||12.052|1.740|0.002
91542839|NCT03538717|182964880|SUPERIORITY|||||||0.024|||||||Chi-squared|||Bone||||0.024
91542840|NCT03538717|182964880|SUPERIORITY|||||||0.045|||||||Chi-squared|||Another site of metastasis||||0.045
91542841|NCT03538717|182964881|SUPERIORITY|||||||0.555|||||||Chi-squared|||LDH level \>1.5\*ULN||||0.555
91542842|NCT03538717|182964881|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Hgb levels \<=LLN||||<0.001
91542843|NCT03538717|182964881|SUPERIORITY|||||||0.344|||||||Chi-squared|||Corrected Ca levels \>10 mg/dL||||0.344
91542844|NCT03538717|182964881|SUPERIORITY||||||>|0.999|||||||Chi-squared|||Neutrophil levels \>ULN||||>0.999
91542845|NCT03538717|182964881|SUPERIORITY|||||||0.795|||||||Chi-squared|||Platelet levels \>ULN||||0.795
91542846|NCT03538717|182964881|SUPERIORITY|||||||0.184|||||||Chi-squared|||Neutrophil-to-lymphocyte ratio \<=3||||0.184
91542847|NCT03538717|182964882|SUPERIORITY|||||||0.235|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.235
91542848|NCT03628885|182964904|SUPERIORITY||||||<|0.02||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||<.02
91542849|NCT03628885|182964904|SUPERIORITY||||||=|0.07||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||=.07
91542850|NCT03628885|182964904|SUPERIORITY||||||<|0.01||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05||||<.01
91542851|NCT00106080|182964911|SUPERIORITY_OR_OTHER_LEGACY||Difference between groups after adjust|5.7||||0.03||||||No multiple comparisons, a priori threshold \< 0.05|GEE regression|Generalized estimating equations (GEE) regression, clustering for provider.||Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.||||0.03
91542852|NCT01839331|182964913|SUPERIORITY|||||||0.004||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.004
91542853|NCT01839331|182964913|SUPERIORITY|||||||0.017||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.017
91542854|NCT01839331|182964913|SUPERIORITY|||||||0.093||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.093
91542855|NCT01839331|182964914|SUPERIORITY|Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.||||||0.0442|||||||ANOVA|||||||0.0442
91542856|NCT01839331|182964915|SUPERIORITY|||||||0.4133||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.4133
91542857|NCT01839331|182964916|SUPERIORITY|||||||0.0122||||||Adjusted for injection volume (4 mL or 10 mL) and baseline PGA|ANOVA|||||||0.0122
91542858|NCT03074331|182964925|SUPERIORITY|||||||0.009|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.||||0.009
91542859|NCT03283371|182964939|SUPERIORITY||LS Mean logarithmic difference|-0.16||||0.5053|TWO_SIDED|95.0|-0.62|0.31|||Mixed Model for Repeated Measures (MMRM)|||Analysis is based on MMRM and adjusted for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures), structural etiology category (yes and no), visit, treatment and treatment by visit interaction. An unstructured variance-covariance matrix is used in the model.||0.31|-0.62|0.5053
91542860|NCT03283371|182964940|SUPERIORITY||Odds Ratio (OR)|2.09||||0.2231|TWO_SIDED|95.0|0.64|6.85|||Regression, Logistic|||Based on logistic regression with a term for treatment group and with adjustment for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no).||6.85|0.64|0.2231
91542861|NCT03283371|182964943|SUPERIORITY||Odds Ratio (OR)|0.67||||0.6854|TWO_SIDED|95.0|0.1|4.57|||Regression, Logistic|||Based on the logistic regression model with a term for treatment group and with adjustment for log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no) are considered as covariates.||4.57|0.10|0.6854
91542862|NCT01290341|182964947|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification by site was used to compare subjects with complete cure between NAFT-600 and Placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
91542863|NCT01943799|182964960|SUPERIORITY||LS Mean Difference|-0.001||||0.976|TWO_SIDED|95.0|-0.061|0.059|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.059|-0.061|0.976
91542864|NCT01943799|182964960|SUPERIORITY||LS Mean Difference|-0.007||||0.828|TWO_SIDED|95.0|-0.067|0.053|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.053|-0.067|0.828
91542865|NCT01943799|182964960|SUPERIORITY||LS Mean Difference|-0.029||||0.343|TWO_SIDED|95.0|-0.089|0.031|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.031|-0.089|0.343
91542866|NCT02574455|182965022|OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.305|0.492||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.492|0.305|<0.0001
91542867|NCT02574455|182965023|OTHER||Hazard Ratio (HR)|0.413|||<|0.0001|TWO_SIDED|95.0|0.33|0.517||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.517|0.330|<0.0001
91542868|NCT02574455|182965024|OTHER||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.39|0.592||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.592|0.390|<0.0001
91542869|NCT02574455|182965025|OTHER||Hazard Ratio (HR)|0.514|||<|0.0001|TWO_SIDED|95.0|0.422|0.625||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.625|0.422|<0.0001
91542870|NCT02574455|182965026|OTHER||Odds Ratio (OR)|10.859|||<|0.0001|TWO_SIDED|95.0|5.59|21.095|||Cochran-Mantel-Haenszel|||ORR by IRC Assessment||21.095|5.590|<0.0001
91542871|NCT02574455|182965026|OTHER||Odds Ratio (OR)|7.363|||<|0.0001|TWO_SIDED|95.0|4.063|13.341|||Cochran-Mantel-Haenszel|||ORR by Investigator Assessment||13.341|4.063|<0.0001
91542872|NCT02574455|182965029|OTHER||Hazard Ratio (HR)|0.407||||0.0683|TWO_SIDED|95.0|0.15|1.107||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by IRC Assessment||1.107|0.150|0.0683
91542873|NCT02574455|182965029|OTHER||Hazard Ratio (HR)|0.212|||<|0.0001|TWO_SIDED|95.0|0.103|0.435||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by Investigator Assessment||0.435|0.103|<0.0001
91542874|NCT02574455|182965030|OTHER||Hazard Ratio (HR)|0.317|||<|0.0001|TWO_SIDED|95.0|0.248|0.404||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by Investigator Assessment||0.404|0.248|<0.0001
91542875|NCT02574455|182965031|OTHER||Hazard Ratio (HR)|0.406|||<|0.0001|TWO_SIDED|95.0|0.315|0.525||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by IRC Assessment||0.525|0.315|<0.0001
91542876|NCT02574455|182965032|OTHER||Odds Ratio (OR)|8.543|||<|0.0001|TWO_SIDED|95.0|5.055|14.437|||Cochran-Mantel-Haenszel|||CBR by IRC Assessment||14.437|5.055|<0.0001
91542877|NCT02574455|182965032|OTHER||Odds Ratio (OR)|7.492|||<|0.0001|TWO_SIDED|95.0|4.54|12.364|||Cochran-Mantel-Haenszel|||CBR by Investigator Assessment||12.364|4.540|<0.0001
91542878|NCT05505045|182965109|OTHER||Cohen's d effect size|0.44|||||TWO_SIDED|95.0|-0.16|1.05||||||||1.05|-.16|
91542879|NCT05505045|182965110|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.19|1.03||||||||1.03|-.19|
91542880|NCT05505045|182965111|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.3|0.93||||||||0.93|-.30|
91542881|NCT05505045|182965112|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|96.0|-1.04|0.21||||||||0.21|-1.04|
91542882|NCT05505045|182965117|OTHER||Cohen's d effect size|0.01|||||TWO_SIDED|95.0|-0.61|0.64||||||||.64|-.61|
91542883|NCT01643070|182965118|SUPERIORITY||Odds Ratio (OR)|1.5||||0.719|TWO_SIDED|95.0|0.346|6.501|||t-test, 1 sided|||||6.501|0.346|0.719
91542884|NCT02975505|182965124|SUPERIORITY||beta|11.7|||<|0.05|TWO_SIDED|95.0|7.5|16.0|||Mixed Models Analysis|||||16|7.5|<0.05
91542885|NCT02975505|182965127|SUPERIORITY||beta|12.5||||0.05|TWO_SIDED|95.0|8.0|16.0|||Mixed Models Analysis|||||16|8|0.05
91542886|NCT04201834|182965140|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
91542887|NCT04201834|182965141|SUPERIORITY|||||||0.92|||||||Paired T-Test|||||||0.92
91542888|NCT04201834|182965142|SUPERIORITY|||||||0.36|||||||Paired T-Test|||||||0.36
91542889|NCT04201834|182965143|SUPERIORITY|||||||0.62|||||||Paired T-Test|||||||0.62
91542890|NCT04201834|182965146|SUPERIORITY|||||||0.11|||||||Paired T-Test|||||||0.11
91542891|NCT04201834|182965147|SUPERIORITY|||||||0.02|||||||Paired T-Test|||||||0.02
91542892|NCT04201834|182965149|SUPERIORITY|||||||0.86|||||||Paired T-Test|||||||0.86
91542893|NCT04201834|182965150|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
91542894|NCT04201834|182965151|SUPERIORITY|||||||0.61|||||||Paired T-Test|||||||0.61
91542895|NCT04201834|182965152|SUPERIORITY|||||||0.37|||||||Paired T-Test|||||||0.37
91542896|NCT04201834|182965153|SUPERIORITY|||||||0.3|||||||Paired T-Test|||||||0.30
91542897|NCT04201834|182965154|SUPERIORITY|||||||0.82|||||||Paired t-test|||||||0.82
91542898|NCT05540535|182965155|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
91542899|NCT05540535|182965156|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91542900|NCT05540535|182965157|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
91542901|NCT05540535|182965158|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91542902|NCT05540535|182965159|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
91542903|NCT05540535|182965160|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
91542904|NCT05540535|182965161|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
91542905|NCT02980276|182965171|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.9||||0.13|TWO_SIDED|95.0|-15.1|1.4||The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.|Risk difference||Units are %|The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.||1.4|-15.1|0.13
91542906|NCT02980276|182965172|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-12.7||||0.004|TWO_SIDED|95.0|-21.2|-4.3|||Risk difference||Units are %|||-4.3|-21.2|0.004
91542907|NCT02980276|182965173|SUPERIORITY|||||||0.001|||||||Log Rank|Median survival times could not be calculated; time to insulin initiation would be censored at delivery in \>50% of participants in treatment group.||||||0.001
91542908|NCT02980276|182965174|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio, log|0.61||||0.005|TWO_SIDED|95.0|0.43|0.86|||Regression, Logistic|Unadjusted|Unadjusted|||0.86|0.43|0.005
91542909|NCT02980276|182965174|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.56||||0.003|TWO_SIDED|95.0|0.38|0.82|||Regression, Logistic|Adjusted|Adjusted|||0.82|0.38|0.003
91542910|NCT02980276|182965175|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.78||||0.178|TWO_SIDED|95.0|0.55|1.12|||Regression, Logistic||Unadjusted|||1.12|0.55|0.178
91542911|NCT02980276|182965175|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.72||||0.105|TWO_SIDED|95.0|0.48|1.07||Two-sided test comparing observed odds ratio to 1.|Regression, Logistic||Adjusted|||1.07|0.48|0.105
91542912|NCT02980276|182965176|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-3.7||||0.17|TWO_SIDED|95.0|-9.3|1.7|||t-test, 2 sided|||||1.7|-9.3|0.17
91542913|NCT02980276|182965177|EQUIVALENCE|Two-sided test comparing observed mean difference ratio to zero.|Mean Difference (Final Values)|-1.2||||0.003|TWO_SIDED|95.0|-1.99|-0.42|||t-test, 2 sided|||||-0.42|-1.99|0.003
91542914|NCT02980276|182965178|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.99|TWO_SIDED|95.0|0.65|1.55|||Regression, Logistic|||||1.55|0.65|0.99
91542915|NCT02980276|182965179|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.96||||0.911|TWO_SIDED|95.0|0.46|2.0|||Regression, Logistic|||||2|0.46|0.911
91542916|NCT02980276|182965180|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.82||||0.519|TWO_SIDED|95.0|0.44|1.51|||Regression, Logistic|||||1.51|0.44|0.519
91542917|NCT02980276|182965181|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.66|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||||0.2|-0.3|0.66
91542918|NCT02980276|182965182|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.367|TWO_SIDED|95.0|0.8|1.85|||Regression, Logistic|Unadjusted|Unadjusted|||1.85|0.8|0.367
91542919|NCT02980276|182965182|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.22||||0.359|TWO_SIDED|95.0|0.8|1.87|||Regression, Logistic|Adjusted|Adjusted|||1.87|0.8|0.359
91542920|NCT02980276|182965183|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.5||||1|TWO_SIDED|95.0|-13.9|12.9|||Risk difference||Units are %|||12.9|-13.9|1.0
91542921|NCT02980276|182965184|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.603|TWO_SIDED|95.0|0.56|1.39|||Regression, Logistic|Unadjusted|Unadjusted|||1.39|0.56|0.603
91542922|NCT02980276|182965184|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.621|TWO_SIDED|95.0|0.57|1.4|||Regression, Logistic|Adjusted|Adjusted|||1.4|0.57|0.621
91542923|NCT02980276|182965185|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.739|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|Unadjusted|Unadjusted|||1.76|0.45|0.739
91542924|NCT02980276|182965185|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.92||||0.812|TWO_SIDED|95.0|0.46|1.84|||Regression, Logistic|Adjusted|Adjusted|||1.84|0.46|0.812
91542925|NCT02980276|182965186|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.84||||0.282|TWO_SIDED|95.0|0.63|6.04|||Regression, Logistic|Unadjusted|Unadjusted|Unadjusted||6.04|0.63|0.282
91542926|NCT02980276|182965186|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|2.14||||0.196|TWO_SIDED|95.0|0.7|7.38|||Regression, Logistic||Adjusted|||7.38|0.7|0.196
91542927|NCT02980276|182965187|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.058|TWO_SIDED|95.0|0.27|1.01|||Regression, Logistic|Unadjusted||||1.01|0.27|0.058
91542928|NCT02980276|182965187|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.061|TWO_SIDED|95.0|0.27|1.02|||Regression, Logistic|Adjusted||||1.02|0.27|0.061
91542929|NCT02980276|182965188|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-4.5||||0.24|TWO_SIDED|95.0|-11.6|2.5|||Risk difference||Units are %|||2.5|-11.6|0.24
91542930|NCT02980276|182965188|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.81||||0.24|TWO_SIDED|95.0|0.59|1.12|||Regression, Logistic||Units are %|||1.12|0.59|0.24
91763922|NCT00286429|183418398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.291|TWO_SIDED|95.0|-0.81|0.24||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.24|-0.81|0.291
91542931|NCT02980276|182965189|EQUIVALENCE|Regression model that adjusts for the infant's sex and maternal height and weight at randomization.|Median Difference (Final Values)|-113.0||||0.005|TWO_SIDED|95.0|-201.0|-24.0|||Regression, Linear|P value was derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization.||||-24|-201|0.005
91542932|NCT02980276|182965190|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.82|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.82
91542933|NCT02980276|182965191|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-0.7||||0.02|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||||-0.2|-1.3|0.02
91542934|NCT02980276|182965192|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||||0.7|-0.5|0.72
91542935|NCT02980276|182965193|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided|||||0.1|-0.1|0.68
91542936|NCT02980276|182965194|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-7.2||||0.02|TWO_SIDED|95.0|-12.6|-1.8|||Regression, Logistic|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|||-1.8|-12.6|0.02
91542937|NCT02980276|182965195|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-8.4||||0.003|TWO_SIDED|95.0|-13.7|-3.2|||Risk difference|P value derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization|Units are %|||-3.2|-13.7|0.003
91542938|NCT02980276|182965196|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.7||||0.012|TWO_SIDED|95.0|-1.0|6.3|||Risk difference|Units are %. P value derived from model adjusting for the gestational age at birth, sex and maternal height and weight at randomization.|Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.3|-1|.012
91542939|NCT02980276|182965197|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.13|TWO_SIDED|95.0|-0.4|6.5||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|Regression, Logistic||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.5|-0.4|0.13
91542940|NCT02980276|182965198|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.38|TWO_SIDED|95.0|-2.9|9.0|||Risk difference||Units are %.|||9|-2.9|0.38
91542941|NCT02980276|182965199|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.8||||0.33|TWO_SIDED|95.0|-2.0|7.3|||Risk difference||Units are %|||7.3|-2.0|0.33
91542942|NCT02980276|182965200|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.3||||0.42|TWO_SIDED|95.0|-2.4|6.9|||Risk difference||Units are %|||6.9|-2.4|0.42
91542943|NCT02980276|182965201|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.4|||>|0.99|TWO_SIDED|95.0|-0.4|1.1|||Risk difference||Units are %.|||1.1|-0.4|>0.99
91542944|NCT02980276|182965202|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|1.1||||0.62|TWO_SIDED|95.0|-1.9|4.2|||Risk difference||Units are %|||4.2|-1.9|0.62
91542945|NCT02980276|182965203|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.0|||>|0.99|TWO_SIDED|95.0|-1.0|1.0|||Risk difference||Units are %|||1|-1|>0.99
91542946|NCT02980276|182965204|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.7||||0.9|TWO_SIDED|95.0|-5.1|6.6|||Risk difference||Units are %|||6.6|-5.1|0.9
91542947|NCT05857644|182965205|OTHER||Geometric mean ratio|84.33|||||TWO_SIDED|90.0|50.94|139.59|||||Mild Hepatic Impairment versus No Hepatic Impairment|||139.59|50.94|
91542948|NCT05857644|182965205|OTHER||Geometric mean ratio|90.89|||||TWO_SIDED|90.0|54.91|150.45|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||150.45|54.91|
91542949|NCT05857644|182965205|OTHER||Geometric mean ratio|157.23|||||TWO_SIDED|90.0|84.81|291.49|||||Severe Hepatic Impairment versus No Hepatic Impairment|||291.49|84.81|
91542950|NCT05857644|182965206|OTHER||Geometric mean ratio|82.17|||||TWO_SIDED|90.0|49.24|137.11|||||Mild Hepatic Impairment versus No Hepatic Impairment|||137.11|49.24|
91542951|NCT05857644|182965206|OTHER||Geometric mean ratio|130.82|||||TWO_SIDED|90.0|78.4|218.3|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||218.30|78.40|
91763923|NCT00286429|183418398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.439|TWO_SIDED|95.0|-0.74|0.32||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.32|-0.74|0.439
91542952|NCT05857644|182965206|OTHER||Geometric mean ratio|385.52|||||TWO_SIDED|90.0|205.92|721.77|||||Severe Hepatic Impairment versus No Hepatic Impairment|||721.77|205.92|
91542953|NCT05857644|182965207|OTHER||Geometric mean ratio|82.99|||||TWO_SIDED|90.0|50.53|136.28|||||Mild Hepatic Impairment versus No Hepatic Impairment|||136.28|50.53|
91542954|NCT05857644|182965207|OTHER||Geometric mean ratio|131.52|||||TWO_SIDED|90.0|80.09|215.99|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||215.99|80.09|
91542955|NCT05857644|182965207|OTHER||Geometric mean ratio|392.1|||||TWO_SIDED|90.0|213.57|719.85|||||Severe Hepatic Impairment versus No Hepatic Impairment|||719.85|213.57|
91542956|NCT01643616|182965215|SUPERIORITY_OR_OTHER||Percentage Difference|33.0|||<|0.05|||||||Fisher Exact||For success rate without supplementation the difference between group US (94.9%) and group NS (61.9%) is 33%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||< 0.05
91542957|NCT01643616|182965216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.9|||<|0.05|TWO_SIDED|95.0|13.6|31.1|||Log Rank|||We used the log-rank test to compare the onset times. The significance level was defined with p\<0.05.||31.1|13.6|< 0.05
91542958|NCT01643616|182965217|SUPERIORITY_OR_OTHER||Percentage Difference|26.2||||0.05|||||||Fisher Exact||For success rate with supplementation the difference between group US (98.2%) and group NS (72%) is 26.2%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||0.05
91542959|NCT04512482|182965218|SUPERIORITY|||||||0.044|||||||ANOVA|||A power analysis determined that a sample size of forty-five (45) subjects would possess 90% power to detect an effect size of 0.5 between the intervention and control legs of the crossover design. With 43 total subjects the study had between 85 and 90% power.||||.044
91542960|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-concomitant Group. GMT Ratio is reported for Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 6||1.61|0.92|
91542961|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.33|||||TWO_SIDED|95.0|1.01|1.75|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 11||1.75|1.01|
91542962|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 16||1.82|1.02|
91542963|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.25|||||TWO_SIDED|95.0|0.92|1.7|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 18||1.70|0.92|
91542964|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.21|||||TWO_SIDED|95.0|0.91|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 31||1.61|0.91|
91542965|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 33||1.77|0.98|
91542966|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.93|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 45||1.93|1.01|
91542967|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.45|||||TWO_SIDED|95.0|1.13|1.87|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 52||1.87|1.13|
91542968|NCT05119855|182965219|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.2|||||TWO_SIDED|95.0|0.91|1.58|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 58||1.58|0.91|
91542969|NCT05119855|182965220|OTHER|Geometric Mean Concentration (GMC) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-SARS-CoV-2 concentrations and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.4|||||GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio||1.40|0.99|
91542970|NCT05489484|182965252|OTHER|Paired-sample t-test was used to assess the change in Constant-Murley Score from baseline to 3 months.|Mean Difference (Net)|10.03|STANDARD_ERROR_OF_MEAN|2.124||0.001|TWO_SIDED|95.0|3.63|16.0|||t-test, 2 sided||Mean change from baseline in CMS at 3 months. Higher scores represent better shoulder function. Positive difference indicates clinical improvement.|Statistical analysis was performed on 23 participants with valid Constant-Murley Score (CMS) data at both baseline and 3-month follow-up.||16.00|3.63|0.001
91542971|NCT00444600|182965276|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-55.0|||<|0.001|TWO_SIDED|95.0|-78.0|-32.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in central subfield thickness mean change from sham+prompt laser||-32|-78|<0.001
91542972|NCT00444600|182965276|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-49.0|||<|0.001|TWO_SIDED|95.0|-72.0|-26.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-26|-72|<0.001
91542973|NCT00444600|182965276|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-52.0|||<|0.001|TWO_SIDED|95.0|-75.0|-29.0||Confidence interval is adjusted for multiple comparisons|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-29|-75|<0.001
91542974|NCT00444600|182965278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.2|8.5||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.5|3.2|<0.001
91542975|NCT00444600|182965278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|3.4|8.6||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.6|3.4|<0.001
91763924|NCT00286429|183418399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.841|TWO_SIDED|95.0|-0.67|0.55||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.55|-0.67|0.841
91542976|NCT00444600|182965278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.31|TWO_SIDED|95.0|-1.5|3.7||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||3.7|-1.5|0.31
91542977|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|23.0|||||TWO_SIDED|95.0|13.0|34.0||Confidence intervals are adjusted for multiple comparisons.|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year||34|13|
91542978|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|19.0|||||TWO_SIDED|95.0|9.0|29.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||29|9|
91542979|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-4.0|16.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||16|-4|
91542980|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.84|||<|0.001|TWO_SIDED|95.0|1.4|2.42||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.42|1.40|<0.001
91542981|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.68|||<|0.001|TWO_SIDED|95.0|1.27|2.21||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.21|1.27|<0.001
91542982|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.21||||0.16|TWO_SIDED|95.0|0.88|1.66||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.|Eyes were analyzed.|Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||1.66|0.88|0.16
91542983|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-5.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-5|-16|
91542984|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-4.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-4|-16|
91542985|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|1.0|||||TWO_SIDED|95.0|-7.0|9.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||9|-7|
91542986|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24|||<|0.001|TWO_SIDED|95.0|0.09|0.65||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.65|0.09|<0.001
91542987|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24||||0.001|TWO_SIDED|95.0|0.08|0.68||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.68|0.08|0.001
91542988|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.08||||0.75|TWO_SIDED|95.0|0.62|1.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||1.87|0.62|0.75
91542989|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|16.0|||||TWO_SIDED|95.0|6.0|26.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between to study eyes.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||26|6|
91542990|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|13.0|||||TWO_SIDED|95.0|4.0|22.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||22|4|
91542991|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-2.0|15.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||15|-2|
91542992|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.09|||<|0.001|TWO_SIDED|95.0|1.35|3.22|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||3.22|1.35|<0.001
91542993|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.89|||<|0.001|TWO_SIDED|95.0|1.25|2.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.87|1.25|<0.001
91542994|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.43||||0.07|TWO_SIDED|95.0|0.9|2.29||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.29|0.90|0.07
91542995|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-11.0|-2.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-2|-11|
91542996|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-10.0|-1.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-1|-10|
91542997|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.0|||||TWO_SIDED|95.0|-6.0|6.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||6|-6|
91542998|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.21||||0.009|TWO_SIDED|95.0|0.05|0.87|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.87|0.05|0.009
91542999|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.28||||0.01|TWO_SIDED|95.0|0.08|0.97|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.97|0.08|0.01
91543000|NCT00444600|182965279|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.02||||0.95|TWO_SIDED|95.0|0.47|2.2|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||2.20|0.47|0.95
91543001|NCT00444600|182965280|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.0|||<|0.001|TWO_SIDED|95.0|1.52|2.64||Confidence intervals are adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.64|1.52|<0.001
91543002|NCT00444600|182965280|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.001|TWO_SIDED|95.0|1.13|2.13||Confidence intervals adjusted for multiple comparisons|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.13|1.13|0.001
91543003|NCT00444600|182965280|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.76|||<|0.001||95.0|1.31|2.36||Confidence intervals adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.36|1.31|<0.001
91543004|NCT00444600|182965290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.08
91543005|NCT00444600|182965290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
91543006|NCT00444600|182965291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.03
91543007|NCT00444600|182965291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
91543008|NCT00444600|182965295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.01|-0.44||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.44|-1.01|<0.001
91543009|NCT00444600|182965295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.41||Confidence intervals adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.41|-0.96|<0.001
91543010|NCT00444600|182965295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.91|-0.34||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.34|-0.91|<0.001
91543011|NCT05132478|182965297|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||||||0.720
91543012|NCT05132478|182965298|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
91543013|NCT05132478|182965299|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||baseline||||0.228
91543014|NCT05132478|182965299|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||Post-Intervention||||0.176
91543015|NCT05132478|182965300|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||baseline||||0.410
91543016|NCT05132478|182965300|SUPERIORITY|||||||0.351|||||||ANOVA|||Post-Intervention||||0.351
91543017|NCT05132478|182965301|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
91543018|NCT05132478|182965302|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
91543019|NCT02549170|182965303|SUPERIORITY||Newcombe confidence interval|-21.8|||=|0.0045|TWO_SIDED|95.0|-34.45|-7.94|||Chi-squared|||||-7.94|-34.45|=0.0045
91543020|NCT02549170|182965305|SUPERIORITY||Newcombe confidence interval|-16.9|||=|0.0896|TWO_SIDED|95.0|-33.02|0.69||The treatment groups were compared using a continuity-corrected chi-square test.|Chi-squared, Corrected|||||0.69|-33.02|=0.0896
91543021|NCT02549170|182965306|SUPERIORITY||||||=|0.002|||||||Wilcoxon Survival Test|||||||=0.002
91543022|NCT02549170|182965307|SUPERIORITY||Least Square Mean|5.2|||=|0.03|TWO_SIDED|95.0|0.5|9.9|||ANCOVA|||||9.9|0.5|=0.030
91543023|NCT03684044|182965405|SUPERIORITY||Median Difference (Net)|-2.7||||0.4666|TWO_SIDED|95.0|-53.4|25.9|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||25.9|-53.4|0.4666
91543024|NCT03684044|182965406|SUPERIORITY|||||||0.6326|||||||Cochran-Mantel-Haenszel|Statistic was stratified by region, NEWS2 at baseline (≤7, \>7), and time from symptom onset to study treatment (≤48 hours, \>48 hours)||||||0.6326
91543025|NCT03684044|182965407|SUPERIORITY||Mean Difference (Net)|-6.8||||0.3272|TWO_SIDED|95.0|-50.9|17.7|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||17.7|-50.9|0.3272
91543026|NCT03703336|182965434|NON_INFERIORITY|If the lower limit of the 95% confidence interval (CI) of the ratio of GMCs between the ROTAVIN and ROTAVIN-M1 groups were to be larger than 1/2, ROTAVIN was considered to be non-inferior to the licensed frozen formulation of the vaccine (ROTAVIN-M1).|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.02|1.86|||||Log10-transformed IgA concentrations were used to construct a 2-sided 95% CI for the mean difference between the arms using t-distribution. The mean difference and 95% CI were exponentiated to obtain the GMC ratio and corresponding 95% CI.|||1.86|1.02|
91543027|NCT03703336|182965436|OTHER||Percentage Difference|6.0|||||TWO_SIDED|95.0|-3.57|15.87||||||||15.87|-3.57|
91543028|NCT03703336|182965437|OTHER||Percentage Difference|0.4|||||TWO_SIDED|95.0|-2.4|2.09||||||Percentage Difference on Day 1||2.09|-2.40|
91543029|NCT03703336|182965437|OTHER||Percentage Difference|6.3|||||TWO_SIDED|95.0|-3.19|16.23||||||Percentage Difference on Day 85||16.23|-3.19|
91543030|NCT04629950|182965454|SUPERIORITY|||||||0.395||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||||||0.395
91543031|NCT04629950|182965454|SUPERIORITY|||||||0.41||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.410
91543032|NCT04629950|182965455|SUPERIORITY|||||||0.691|||||||Fisher Exact|||||||0.691
91543033|NCT04629950|182965455|SUPERIORITY|||||||1||||||P values not adjusted for multiple comparisons.|Fisher Exact|||||||1
91543034|NCT04629950|182965456|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|P value not adjusted for multiple comparisons,||||||0.758
91543035|NCT04629950|182965456|SUPERIORITY|||||||0.247||||||P values not adjusted for multiple comparisons.|Fisher Exact|||Data represent change values.||||0.247
91543036|NCT04629950|182965457|SUPERIORITY|||||||0.316||||||P values were not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.316
91543037|NCT04629950|182965457|SUPERIORITY|||||||0.605||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Data represent change values.||||0.605
91543038|NCT04629950|182965458|SUPERIORITY|||||||0.192||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch||||0.192
91543039|NCT04629950|182965458|SUPERIORITY|||||||0.392||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch. Data represent change values.||||0.392
91543040|NCT04629950|182965458|SUPERIORITY|||||||0.347||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Mean Reduction in Maximum Itch||||0.347
91543041|NCT04629950|182965458|SUPERIORITY|||||||0.572||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Maximum Itch. Data represent change values.||||0.572
91543042|NCT04629950|182965459|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
91543043|NCT04629950|182965460|OTHER|||||||0.141|||||||Wilcoxon (Mann-Whitney)|||||||0.141
91543044|NCT04629950|182965461|OTHER|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
91543045|NCT04629950|182965462|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
91543046|NCT04629950|182965463|OTHER|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
91543047|NCT04629950|182965464|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
91543048|NCT04629950|182965465|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||0.221
91543049|NCT04629950|182965465|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||0.286
91543050|NCT04629950|182965466|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||1
91543051|NCT04629950|182965466|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||1
91543052|NCT02708108|182965474|OTHER|Multivariable analysis|Odds Ratio (OR)|0.3||||0.02|TWO_SIDED|95.0|0.09|0.92||Reported as 1-sided p-value.|Regression, Logistic||Multivariable model includes age, BMI category, cytogenetic risk, ethnicity, sex|||0.92|0.09|0.02
91543053|NCT00891436|182965488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||paired t-test was used for the data analysis||||>0.1
91543054|NCT00891436|182965488|NON_INFERIORITY_OR_EQUIVALENCE|t-test showed no different between the 2 groups.|Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||||||>0.1
91543055|NCT05113771|182965499|SUPERIORITY||LS Mean Difference|-4.4||||0.0056|TWO_SIDED|95.0|-7.6|-1.3|||MMRM|mixed model for repeated measures (MMRM) with imputation based on the missing at random (MAR) assumption was used.||||-1.3|-7.6|0.0056
91543056|NCT05113771|182965500|SUPERIORITY|||||||0.0189|||||||MMRM|||||||0.0189
91543057|NCT05113771|182965501|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||||||0.0026
91543058|NCT03887650|182965567|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||||||0.127
91543059|NCT03887650|182965568|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||||||.975
91543060|NCT03887650|182965569|SUPERIORITY|||||||0.852||||||PACU pain scores|Wilcoxon (Mann-Whitney)|||||||.852
91543061|NCT03887650|182965569|SUPERIORITY|||||||0.661||||||For (PACU-24) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.661
91543062|NCT03887650|182965569|SUPERIORITY|||||||0.747||||||For (PACU-24 hr.) maximum pain score|Wilcoxon (Mann-Whitney)|||||||.747
91543063|NCT03887650|182965569|SUPERIORITY|||||||0.604||||||For (PACU-24 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.604
91543064|NCT03887650|182965569|SUPERIORITY|||||||0.002||||||(24-48 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.002
91543065|NCT03887650|182965569|SUPERIORITY||||||<|0.01||||||For (24-48 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
91543066|NCT03887650|182965569|SUPERIORITY||||||<|0.01||||||For (24-48 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
91543067|NCT03887650|182965569|SUPERIORITY|||||||0.011||||||(48-72 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.011
91543068|NCT03887650|182965569|SUPERIORITY|||||||0.001||||||(48-72 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
91543069|NCT03887650|182965569|SUPERIORITY|||||||0.003||||||(48-72 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.003
91543070|NCT03887650|182965569|SUPERIORITY|||||||0.23||||||For (72-96 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.230
91543071|NCT03887650|182965569|SUPERIORITY|||||||0.007||||||For (72-96 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.007
91763925|NCT00286429|183418399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.43|-0.80|0.556
91763926|NCT00286429|183418400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.586|TWO_SIDED|95.0|-0.81|0.46||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.46|-0.81|0.586
91763927|NCT00286429|183418400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.404|TWO_SIDED|95.0|-0.91|0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.37|-0.91|0.404
91763928|NCT00286429|183418401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.874|TWO_SIDED|95.0|-0.62|0.72||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.72|-0.62|0.874
91543072|NCT03887650|182965569|SUPERIORITY|||||||0.011||||||For (72-96 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.011
91543073|NCT03887650|182965569|SUPERIORITY|||||||0.378||||||For (postoperative day 60) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.378
91543074|NCT03887650|182965569|SUPERIORITY|||||||0.001||||||For (postoperative day 60) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
91543075|NCT03887650|182965569|SUPERIORITY|||||||0.403||||||For (postoperative day 60) average pain scores|Wilcoxon (Mann-Whitney)|||||||.403
91543076|NCT03887650|182965570|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||.112
91543077|NCT03887650|182965571|SUPERIORITY|||||||0.096||||||P-Value for POD4|Fisher Exact|Fisher's Exact for POD4||||||0.096
91543078|NCT03887650|182965571|SUPERIORITY|||||||1||||||For POD60|Chi-squared|Chi-squared for POD60||||||1.0
91543079|NCT03887650|182965572|SUPERIORITY|||||||1||||||Any distress on PACU|Chi-squared|||||||1.0
91543080|NCT03887650|182965572|SUPERIORITY|||||||0.947||||||Postoperative day 2|Chi-squared|||||||.947
91543081|NCT03887650|182965573|SUPERIORITY|||||||0.441||||||Full sensation|Fishers Freeman Halton|||||||.441
91543082|NCT03887650|182965573|SUPERIORITY|||||||0.691||||||First sensation|Fishers Freeman Halton|||||||.691
91543083|NCT03887650|182965574|SUPERIORITY|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
91543084|NCT03887650|182965575|SUPERIORITY|||||||0.011||||||Any movement|Fisher' Freeman Halton|||||||.011
91543085|NCT03887650|182965575|SUPERIORITY|||||||0.536||||||Full movement|Fishers Freeman Halton|||||||.536
91543086|NCT03887650|182965576|SUPERIORITY|||||||0.648||||||MME 0-24|Wilcoxon (Mann-Whitney)|||||||.648
91543087|NCT03887650|182965576|SUPERIORITY|||||||0.285||||||MME24-48|Wilcoxon (Mann-Whitney)|||||||.285
91543088|NCT03887650|182965576|SUPERIORITY|||||||0.122||||||MME48-72|Wilcoxon (Mann-Whitney)|||||||.122
91543089|NCT03887650|182965576|SUPERIORITY|||||||0.367||||||MME 72-120|Wilcoxon (Mann-Whitney)|||||||.367
91543090|NCT01199705|182965624|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.39||||||||1.390||
91543091|NCT01199705|182965624|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.953||||||||0.953||
91543092|NCT01199705|182965624|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.914||||||||0.914||
91543093|NCT01199705|182965626|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.204||||||||1.204||
91543094|NCT01199705|182965626|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.834||||||||0.834||
91543095|NCT01199705|182965626|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.802||||||||0.802||
91543096|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-4.98|2.54||||||SBP||2.54|-4.98|
91543097|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-4.7|2.53||||||SBP||2.53|-4.70|
91543098|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-1.54|||||TWO_SIDED|90.0|-5.3|2.22||||||SBP||2.22|-5.30|
91543099|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-1.53|||||TWO_SIDED|90.0|-5.16|2.1||||||SBP||2.10|-5.16|
91543100|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-3.84|||||TWO_SIDED|90.0|-7.74|0.07||||||SBP||0.07|-7.74|
91543101|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-0.38|||||TWO_SIDED|90.0|-2.95|2.18||||||DBP||2.18|-2.95|
91543102|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-3.69|1.48||||||DBP||1.48|-3.69|
91543103|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|90.0|-3.75|1.85||||||DBP||1.85|-3.75|
91543104|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|90.0|-4.09|1.1||||||DBP||1.10|-4.09|
91543105|NCT01849055|182965635|SUPERIORITY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|90.0|-5.23|0.2||||||DBP||0.20|-5.23|
91543106|NCT00933400|182965636|EQUIVALENCE|equivalence margin = 0|Percent Difference|0.02|||||TWO_SIDED|95.0|-5.6|5.7||||||Difference in AMI rate. NULL: equal rates of AMI in both Groups.||5.7|-5.6|
91543107|NCT00933400|182965637|EQUIVALENCE|equivalence margin = 0|Difference (rates)|26.8|||||TWO_SIDED|95.0|21.4|32.2||||||Difference in Discharge rates. H0: equal rates of Discharge in both Groups.||32.2|21.4|
91543108|NCT00933400|182965637|EQUIVALENCE|equivalence margin = 0|Difference (percents)|5.6|||||TWO_SIDED|95.0|0.0|11.2|||||exact procedures were used to estimate and compare rates of detection for significant coronary disease|Difference in diagnosis rate of Significant coronary disease at index visit. H0: equal rates in both Groups.||11.2|0.0|
91543109|NCT00933400|182965639|SUPERIORITY||binomial proportion|26.8|||||TWO_SIDED|95.0|21.4|32.2|||||Exact confidence intervals for the difference in proportions|H0: no difference in Patient disposition (Discharge) rates between arms||32.2|21.4|
91543110|NCT00933400|182965641|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|-0.4|||||TWO_SIDED|95.0|-6.0|5.2|||||Exact confidence intervals for the difference in proportions|Compare all cause mortality between groups||5.2|-6.0|
91543111|NCT00933400|182965641|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.5|5.7|||||Exact confidence intervals for the difference in proportions|Compare Cardiac Death between groups||5.7|-5.5|
91543112|NCT00933400|182965641|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.6|5.9|||||Exact confidence intervals for the difference in proportions|Compare AMI between groups||5.9|-5.6|
91543113|NCT00933400|182965641|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|3.0|||||TWO_SIDED|95.0|-5.5|6.0|||||Exact confidence intervals for the difference in proportions|Compare MACE between groups||6.0|-5.5|
91543114|NCT00933400|182965641|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|1.3|||||TWO_SIDED|95.0|-4.4|7.0|||||Exact confidence intervals for the difference in proportions|Compare Revascularization between groups||7.0|-4.4|
91543115|NCT02409667|182965651|NON_INFERIORITY|The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.|Odds Ratio (OR)|1.91||||0.1499|TWO_SIDED|95.0|1.44|2.55|||Regression, Logistic|||||2.55|1.44|0.1499
91543116|NCT02409667|182965652|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1013|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|||||1.10|0.35|0.1013
91543117|NCT02409667|182965655|SUPERIORITY||Least square mean (LSM) estimate|-0.09||||0.0489|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA|||Week 28||-0.00|-0.18|0.0489
91543118|NCT02409667|182965655|SUPERIORITY||LSM estimate|-0.09||||0.1073|TWO_SIDED|95.0|-0.19|0.02|||ANCOVA|||Week 32||0.02|-0.19|0.1073
91543119|NCT02409667|182965655|SUPERIORITY||LSM estimate|-0.24||||0.0001|TWO_SIDED|95.0|-0.37|-0.12|||ANCOVA|||Week 36||-0.12|-0.37|0.0001
91543120|NCT02409667|182965655|SUPERIORITY||LSM estimate|-0.25||||0.0005|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Week 40||-0.11|-0.38|0.0005
91543121|NCT02409667|182965655|SUPERIORITY||LSM estimate|-0.3||||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Week 44||-0.15|-0.45|0.0001
91543122|NCT02409667|182965655|SUPERIORITY||LSM estimate|-0.49||||0|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 48||-0.27|-0.70|0.0000
91543123|NCT02409667|182965655|SUPERIORITY||LSM mean|-0.59||||0|TWO_SIDED|95.0|-0.81|-0.36|||ANCOVA|||||-0.36|-0.81|0.0000
91543124|NCT02409667|182965656|SUPERIORITY||LSM estimate|0.4||||0.174|TWO_SIDED|95.0|-0.18|0.99|||ANCOVA|||Week 28||0.99|-0.18|0.1740
91543125|NCT02409667|182965656|SUPERIORITY||LSM estimate|0.79||||0.0287|TWO_SIDED|95.0|0.08|1.5|||ANCOVA|||Week 32||1.50|0.08|0.0287
91543126|NCT02409667|182965656|SUPERIORITY||LSM estimate|0.62||||0.1202|TWO_SIDED|95.0|-0.16|1.41|||ANCOVA|||Week 36||1.41|-0.16|0.1202
91543127|NCT02409667|182965656|SUPERIORITY||LSM estimate|0.75||||0.1157|TWO_SIDED|95.0|-0.19|1.68|||ANCOVA|||Week 40||1.68|-0.19|0.1157
91543128|NCT02409667|182965656|SUPERIORITY||LSM estimate|0.54||||0.3189|TWO_SIDED|95.0|-0.52|1.59|||ANCOVA|||Week 44||1.59|-0.52|0.3189
91543129|NCT02409667|182965656|SUPERIORITY||LSM estimate|1.17||||0.024|TWO_SIDED|95.0|0.16|2.18|||ANCOVA|||Week 48||2.18|0.16|0.0240
91543130|NCT02409667|182965656|SUPERIORITY||LSM estimate|1.47||||0.009|TWO_SIDED|95.0|0.37|2.57|||ANCOVA|||Week 52||2.57|0.37|0.0090
91543131|NCT02409667|182965657|SUPERIORITY||LSM estimate|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||ANCOVA|||||-0.31|-0.93|0.0001
91543132|NCT02409667|182965658|SUPERIORITY||LSM estimate|1.17||||0.0675|TWO_SIDED|95.0|-0.09|2.42|||ANCOVA|||||2.42|-0.09|0.0675
91543133|NCT02409667|182965659|SUPERIORITY||LSM estimate|-0.97||||0.2101|TWO_SIDED|95.0|-2.48|0.55|||ANCOVA|||Absenteeism||0.55|-2.48|0.2101
91543134|NCT02409667|182965659|SUPERIORITY||LSM estimate|-0.67||||0.2971|TWO_SIDED|95.0|-1.93|0.59|||ANCOVA|||Presenteeism||0.59|-1.93|0.2971
91543135|NCT02409667|182965659|SUPERIORITY||LSM estimate|-0.61||||0.5499|TWO_SIDED|95.0|-2.59|1.38|||ANCOVA|||Total activity impairment||1.38|-2.59|0.5499
91543136|NCT02409667|182965659|SUPERIORITY||LSM estimate|-1.08||||0.0758|TWO_SIDED|95.0|-2.28|0.11|||ANCOVA|||||0.11|-2.28|0.0758
91543137|NCT02409667|182965660|SUPERIORITY||LSM estimate|1.2||||0.4156|TWO_SIDED|95.0|-1.71|4.11|||ANCOVA|||Absenteeism||4.11|-1.71|0.4156
91543138|NCT02409667|182965660|SUPERIORITY||LSM estimate|0.63||||0.8619|TWO_SIDED|95.0|-6.59|7.85|||ANCOVA|||Presenteeism||7.85|-6.59|0.8619
91543139|NCT02409667|182965660|SUPERIORITY||LSM estimate|-0.61||||0.6139|TWO_SIDED|95.0|-6.31|10.61|||ANCOVA|||Total activity impairment||10.61|-6.31|0.6139
91543140|NCT02409667|182965660|SUPERIORITY||LSM estimate|1.7||||0.5674|TWO_SIDED|95.0|-4.16|7.56|||ANCOVA|||Work productivity loss||7.56|-4.16|0.5674
91543141|NCT02409667|182965661|SUPERIORITY||LSM estimate|-0.13||||0.1219|TWO_SIDED|95.0|-0.3|0.04|||ANCOVA|||Pain||0.04|-0.30|0.1219
91543142|NCT02409667|182965661|SUPERIORITY||LSM estimate|-0.38||||0.0001|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Itching||-0.18|-0.57|0.0001
91543143|NCT02409667|182965661|SUPERIORITY||LSM estimate|-0.31||||0.0003|TWO_SIDED|95.0|-0.48|-0.14|||ANCOVA|||Scaling||-0.14|-0.48|0.0003
91543144|NCT02409667|182965662|SUPERIORITY||LSM estimate|0.17||||0.6457|TWO_SIDED|95.0|-0.57|0.92|||ANCOVA|||Pain||0.92|-0.57|0.6457
91543145|NCT02409667|182965662|SUPERIORITY||LSM estimate|0.19||||0.6136|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Itching||0.94|-0.56|0.6136
91543146|NCT02409667|182965662|SUPERIORITY||LSM estimate|0.75||||0.0203|TWO_SIDED|95.0|0.12|1.39|||ANCOVA|||Scaling||1.39|0.12|0.0203
91543147|NCT02409667|182965663|SUPERIORITY||LSM estimate|2.22||||0.0027|TWO_SIDED|95.0|0.77|3.68|||ANCOVA|||||3.68|0.77|0.0027
91543148|NCT02409667|182965664|SUPERIORITY||LSM estimate|-2.31||||0.2823|TWO_SIDED|95.0|-6.55|1.92|||ANCOVA|||||1.92|-6.55|0.2823
91543149|NCT02409667|182965665|SUPERIORITY||LSM estimate|0.01||||0.0861|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|||Germany||0.02|-0.00|0.0861
91543150|NCT02409667|182965665|SUPERIORITY||LSM estimate|0.02||||0.0117|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|||UK||0.04|0.00|0.0117
91543151|NCT02409667|182965666|SUPERIORITY||LSM estimate|-0.02||||0.1852|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Germany||0.01|-0.05|0.1852
91543152|NCT02409667|182965666|SUPERIORITY||LSM estimate|-0.03||||0.2203|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||UK||0.02|-0.07|0.2203
91543153|NCT05057897|182965751|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.18|3.01|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.01|0.18|
91543154|NCT05057897|182965752|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-30.36|||||TWO_SIDED|95.0|-62.82|3.69||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||3.69|-62.82|
91543155|NCT05057897|182965753|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.47|||||TWO_SIDED|95.0|0.06|3.86|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.86|0.06|
91543156|NCT05057897|182965754|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-25.0|||||TWO_SIDED|95.0|-59.07|2.97||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||2.97|-59.07|
91543157|NCT05057897|182965755|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.32|||||TWO_SIDED|95.0|0.12|0.8|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||0.80|0.12|
91543158|NCT05057897|182965756|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
91543159|NCT05057897|182965757|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.25|1.25|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||1.25|0.25|
91543160|NCT05057897|182965758|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
91543161|NCT04188379|182965821|SUPERIORITY||Odds Ratio (OR)|4.884||||0.0316|TWO_SIDED|95.0|1.007|43.591|||Cochran-Mantel-Haenszel|||||43.591|1.007|0.0316
91543162|NCT04188379|182965822|SUPERIORITY||Median Difference (Net)|1.0||||0.0009|TWO_SIDED|95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.000|0.000|0.0009
91543163|NCT04188379|182965823|SUPERIORITY||Odds Ratio (OR)|5.224||||0.0108|TWO_SIDED|95.0|1.268|26.268|||Cochran-Mantel-Haenszel|||||26.268|1.268|0.0108
91543164|NCT04188379|182965824|SUPERIORITY||Rate Ratio|0.958||||0.8287|TWO_SIDED|95.0|0.651|1.41|||Wald Test|||||1.41|0.651|0.8287
91543165|NCT04188379|182965825|SUPERIORITY||Odds Ratio (OR)|4.354||||0.0265|TWO_SIDED|95.0|1.048|22.865|||Cochran-Mantel-Haenszel|||||22.865|1.0480|0.0265
91543166|NCT01164098|182965861|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Using Natural Log Transformed Data||T-test of the natural logarithmic transformed data||||0.18
91543167|NCT01164098|182965862|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||T-test of Natural Log Transformed Data.||||0.49
91543168|NCT01164098|182965863|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test||||0.37
91543169|NCT03990649|182965870|SUPERIORITY|||||||0.54||||||The p-values were estimated using a two-sample t-test.|t-test, 2 sided|||||||0.540
91543170|NCT03050814|182965872|OTHER||Hazard Ratio (HR)|1.061||||0.91|TWO_SIDED|95.0|0.38|2.966|||Kaplan Meier|Kaplan-Meier curves and a two-tailed log-rank test||||2.966|0.380|0.91
91543171|NCT02706717|182965875|SUPERIORITY||Mean Difference (Net)|-51.3||||0.6|TWO_SIDED|95.0|-246.0|143.9|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||143.9|-246|0.60
91543172|NCT02706717|182965881|SUPERIORITY||Mean Difference (Net)|0.042||||0.51|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.17|-0.09|0.51
91543173|NCT02706717|182965882|SUPERIORITY||Mean Difference (Net)|28.4||||0.09|TWO_SIDED|95.0|-3.6|71.0|||t-test, 2 sided|2-sample t-test with equal variance|"The estimation parameter is the percent difference between the geometric mean fold changes.~With d-dimer data log10 transformed, this is (exp(Visbiome ES mean minus placebo mean) - 1)\*100."|||71.0|-3.6|0.09
91543174|NCT02706717|182965885|SUPERIORITY||Mean Difference (Net)|-32.7||||0.29|TWO_SIDED|95.0|-93.5|28.2|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||28.2|-93.5|0.29
91543175|NCT02706717|182965886|SUPERIORITY||Mean Difference (Net)|-0.02||||0.41|TWO_SIDED|95.0|-0.08|0.04|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.04|-0.08|0.41
91543176|NCT02706717|182965903|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
91543177|NCT00818246|182965923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
91543178|NCT00818246|182965924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|||||||ANCOVA|||||||<0.001
91543179|NCT00818246|182965925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
91543180|NCT02590432|182965934|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.5|||Fisher's Exact Test|||LINZESS® 145 μg versus (vs) LINZESS® 290 μg||5.5|0.3|1.0000
91543181|NCT02590432|182965934|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0844|TWO_SIDED|95.0|0.1|1.1|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.1|0.1|0.0844
91543182|NCT02590432|182965934|SUPERIORITY||Odds Ratio (OR)|0.9||||1|TWO_SIDED|95.0|0.3|2.5|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.5|0.3|1.0000
91543183|NCT02590432|182965935|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.1|||Fisher's Exact Test|||LINZESS® 145 μg vs LINZESS® 290 μg||5.1|0.3|1.0000
91763929|NCT00286429|183418401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.948|TWO_SIDED|95.0|-0.7|0.65||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.65|-0.70|0.948
91763930|NCT02451514|183418405|OTHER||Geometric mean ratio|1.48|||||TWO_SIDED|95.0|1.03|2.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||2.12|1.03|
91543184|NCT02590432|182965935|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0799|TWO_SIDED|95.0|0.1|1.0|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.0|0.1|0.0799
91543185|NCT02590432|182965935|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7871|TWO_SIDED|95.0|0.3|2.2|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.2|0.3|0.7871
91543186|NCT02590432|182965937|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.993|TWO_SIDED|95.0|0.42|2.19|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.19|0.42|0.9930
91543187|NCT02590432|182965937|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0247|TWO_SIDED|95.0|0.11|0.89|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.89|0.11|0.0247
91543188|NCT02590432|182965937|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.5149|TWO_SIDED|95.0|0.41|1.5|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.50|0.41|0.5149
91763931|NCT02451514|183418405|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.67|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.28|0.67|
91763932|NCT02451514|183418405|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|95.0|0.97|1.96|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.96|0.97|
91543189|NCT02590432|182965938|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.9519|TWO_SIDED|95.0|0.39|2.18|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.18|0.39|0.9519
91543190|NCT02590432|182965938|SUPERIORITY||Hazard Ratio (HR)|0.27||||0.0234|TWO_SIDED|95.0|0.08|0.87|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.87|0.08|0.0234
91543191|NCT02590432|182965938|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4518|TWO_SIDED|95.0|0.39|1.47|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.47|0.39|0.4518
91543192|NCT04788641|182965939|OTHER||Geometric LS Mean Ratio (%)|71.1|||||TWO_SIDED|90.0|65.44|77.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||77.24|65.44|
91543193|NCT04788641|182965939|OTHER||Geometric LS Mean Ratio (%)|102.9|||||TWO_SIDED|90.0|96.11|110.1|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||110.1|96.11|
91543194|NCT04788641|182965940|OTHER||Geometric LS Mean Ratio (%)|62.91|||||TWO_SIDED|90.0|55.64|71.13|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||71.13|55.64|
91543195|NCT04788641|182965940|OTHER||Geometric LS Mean Ratio (%)|97.23|||||TWO_SIDED|90.0|92.93|101.7|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.7|92.93|
91543196|NCT04788641|182965941|OTHER||Geometric LS Mean Ratio (%)|65.57|||||TWO_SIDED|90.0|58.69|73.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||73.24|58.69|
91543197|NCT04788641|182965941|OTHER||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|92.7|101.6|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.6|92.70|
91543198|NCT04788641|182965942|OTHER||Geometric LS Mean Ratio (%)|83.86|||||TWO_SIDED|90.0|73.38|95.84|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||95.84|73.38|
91543199|NCT04788641|182965942|OTHER||Geometric LS Mean Ratio (%)|97.55|||||TWO_SIDED|90.0|87.16|109.2|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||109.2|87.16|
91543200|NCT04788641|182965943|OTHER||Geometric LS Mean Ratio (%)|98.42|||||TWO_SIDED|90.0|94.62|102.4|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||102.4|94.62|
91543201|NCT04788641|182965943|OTHER||Geometric LS Mean Ratio (%)|94.12|||||TWO_SIDED|90.0|85.74|103.3|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||103.3|85.74|
91543202|NCT04247074|182965951|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91543203|NCT04247074|182965952|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91543204|NCT04247074|182965953|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91543205|NCT04247074|182965954|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91543206|NCT03951805|182965955|OTHER||Treatment difference|0.76||||0.7675|TWO_SIDED|95.0|-4.28|5.8|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||5.80|-4.28|0.7675
91543207|NCT03951805|182965955|OTHER||Treatment difference|7.08||||0.0051|TWO_SIDED|95.0|2.12|12.04|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||12.04|2.12|0.0051
91543208|NCT03951805|182965955|OTHER||Treatment difference|5.01||||0.0519|TWO_SIDED|95.0|-0.04|10.05|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||10.05|-0.04|0.0519
91543209|NCT03337399|182965964|NON_INFERIORITY|Non-inferiority of stepped PC was established if the lower one-sided 95% confidence limit for the estimated difference in means was greater than the pre-specified margin of -4.5 points, which corresponds to the one-sided 5% significance level test against this margin.|Mean Difference (Final Values)|2.9|||<|0.05|ONE_SIDED|95.0|-0.01||||Regression, Linear|||The difference in week 24 means between groups was estimated using a linear regression model adjusted for baseline FACT-L score.|||-.01|<0.05
91543210|NCT03337399|182965965|NON_INFERIORITY|Pre-specified margin of -10%.|Estimated Proportions|-2.6|||<|0.15|ONE_SIDED|95.0|-10.4|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Non-inferiority of stepped PC in the proportion reporting patient-clinician communication about end-of-life care at each patient's final follow-up assessment was evaluated using a binomial generalized linear model with identity link and a one-sided test against the pre-specified margin of -10%.|||-10.4|<0.15
91543211|NCT03337399|182965966|NON_INFERIORITY|Pre-specified margin of -7 days|Median Difference (Final Values)|-15.2||||0.15|ONE_SIDED|95.0|-25.1|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Among patients who died, non-inferiority of stepped PC in the mean length of stay in hospice was assessed using linear regression and a one-sided test against the pre-specified margin of -7 days, based upon published quality metrics.|||-25.1|0.15
91543212|NCT03337399|182965967|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.15|TWO_SIDED|95.0|-2.7|-1.8||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15|Regression, Linear|||The difference between groups in the mean number of outpatient PC visits per patient by week 24 was assessed using linear regression and a two-sided superiority test.||-1.8|-2.7|0.15
91543213|NCT01198145|182965971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91543214|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Chi-squared|||Comparing Tenesmus During RT||||0.23
91543215|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Chi-squared|||Comparing Tenesmus after RT||||0.64
91543216|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Chi-squared|||Comparing abdominal pain during RT.||||0.30
91543217|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||Comparing abdominal pain after RT||||0.02
91543218|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||Comparing constipation during RT||||0.70
91543219|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Chi-squared|||Comparing constipation after RT||||0.63
91543220|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Chi-squared|||Comparing diarrhea during RT||||0.44
91543221|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|||||||Chi-squared|||Comparing diarrhea after RT||||0.48
91543222|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||Chi-squared|||Comparing rectal bleeding during RT||||0.38
91543223|NCT01198145|182965972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Chi-squared|||||||0.15
91543224|NCT01198145|182965973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II during RT.||||0.56
91543225|NCT01198145|182965973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II after RT.||||0.74
91543226|NCT02528188|182965979|SUPERIORITY||Risk Difference (RD)|2.39||||0.0123|TWO_SIDED|95.0|0.58|4.68|||Exact methods for risk difference|||||4.68|0.58|0.0123
91543227|NCT02528188|182965979|SUPERIORITY||Risk Difference (RD)|5.61|||<|0.0001|TWO_SIDED|95.0|3.55|8.14|||Exact methods for risk difference|||||8.14|3.55|<0.0001
91543228|NCT02528188|182965980|SUPERIORITY||Rate Difference|23.5||||0.0012|TWO_SIDED|95.0|9.3|37.7|||Poisson model for rate difference|||||37.7|9.3|0.0012
91543229|NCT02528188|182965980|SUPERIORITY||Rate Difference|56.7|||<|0.0001|TWO_SIDED|95.0|38.4|74.9|||Poisson model for rate difference|||||74.9|38.4|<0.0001
91543230|NCT02528188|182965981|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.11||0.0148|TWO_SIDED|95.0|-0.46|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.46|0.0148
91543231|NCT02528188|182965981|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1597|TWO_SIDED|95.0|-0.36|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.36|0.1597
91543232|NCT02528188|182965982|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.52|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-0.52|0.0030
91763933|NCT02451514|183418405|OTHER||Geometric mean ratio|1.98|||||TWO_SIDED|95.0|1.27|3.09|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||3.09|1.27|
91763934|NCT02451514|183418405|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.63|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||1.37|0.63|
91763935|NCT02451514|183418405|OTHER||Geometric mean ratio|1.84|||||TWO_SIDED|95.0|1.2|2.84|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.84|1.20|
91763936|NCT02451514|183418405|OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|95.0|0.96|1.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.85|0.96|
91543233|NCT02528188|182965982|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0691|TWO_SIDED|95.0|-0.4|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.40|0.0691
91543234|NCT02528188|182965983|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3431|TWO_SIDED|95.0|-0.11|0.04||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.11|0.3431
91543235|NCT02528188|182965983|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6332|TWO_SIDED|95.0|-0.09|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.09|0.6332
91543236|NCT02528188|182965984|SUPERIORITY||Risk Difference (RD)|0.5||||0.4082|TWO_SIDED|95.0|-0.75|2.28|||Exact methods for risk difference|||||2.28|-0.75|0.4082
91543237|NCT02528188|182965984|SUPERIORITY||Risk Difference (RD)|1.7||||0.0238|TWO_SIDED|95.0|0.31|3.63|||Exact methods for risk difference|||||3.63|0.31|0.0238
91543238|NCT02528188|182965985|SUPERIORITY||Rate Difference|4.8||||0.2035|TWO_SIDED|95.0|-2.6|12.2|||Poisson model for rate difference|||||12.2|-2.6|0.2035
91543239|NCT02528188|182965985|SUPERIORITY||Rate Difference|16.9||||0.001|TWO_SIDED|95.0|6.8|27.0|||Poisson model for rate difference|||||27.0|6.8|0.0010
91543240|NCT02528188|182965986|SUPERIORITY||Risk Difference|1.99||||0.0248|TWO_SIDED|95.0|0.31|4.17|||Exact methods for risk difference|||Rapidly progressive OA Type 1 or 2||4.17|0.31|0.0248
91543241|NCT02528188|182965986|SUPERIORITY||Risk difference|5.11|||<|0.0001|TWO_SIDED|95.0|3.16|7.54|||Exact methods for risk difference|||Rapidly Progressive OA Type 1 or 2||7.54|3.16|<0.0001
91543242|NCT02528188|182965986|SUPERIORITY||Risk difference|1.79||||0.0366|TWO_SIDED|95.0|0.16|3.92|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||3.92|0.16|0.0366
91543243|NCT02528188|182965986|SUPERIORITY||Risk difference|3.81||||0.0001|TWO_SIDED|95.0|1.99|6.12|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||6.12|1.99|0.0001
91543244|NCT02528188|182965986|SUPERIORITY||Risk difference|0.2||||0.6168|TWO_SIDED|95.0|-0.76|1.71|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||1.71|-0.76|0.6168
91543245|NCT02528188|182965986|SUPERIORITY||Risk difference|1.3||||0.0388|TWO_SIDED|95.0|0.17|2.97|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||2.97|0.17|0.0388
91543246|NCT02528188|182965986|SUPERIORITY||Risk difference|0.1||||0.7245|TWO_SIDED|95.0|-0.74|1.51|||Exact methods for risk difference|||Primary osteonecrosis||1.51|-0.74|0.7245
91543247|NCT02528188|182965986|SUPERIORITY||Risk difference|0.1||||0.7182|TWO_SIDED|95.0|-0.74|1.52|||Exact methods for risk difference|||Primary osteonecrosis||1.52|-0.74|0.7182
91543248|NCT02528188|182965986|SUPERIORITY||Risk difference|0.2||||0.6824|TWO_SIDED|95.0|-0.96|1.9|||Exact methods for risk difference|||Subchondral insufficiency fracture||1.90|-0.96|0.6824
91543249|NCT02528188|182965986|SUPERIORITY||Risk difference|0.3||||0.5632|TWO_SIDED|95.0|-0.86|2.03|||Exact methods for risk difference|||Subchondral insufficiency fracture||2.03|-0.86|0.5632
91543250|NCT02528188|182965987|SUPERIORITY||Rate Difference|19.56||||0.0027|TWO_SIDED|95.0|6.78|32.35|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||32.35|6.78|0.0027
91543251|NCT02528188|182965987|SUPERIORITY||Rate Difference|51.48|||<|0.0001|TWO_SIDED|95.0|34.47|68.5|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||68.50|34.47|<0.0001
91543252|NCT02528188|182965987|SUPERIORITY||Rate Difference|17.58||||0.0047|TWO_SIDED|95.0|5.39|29.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||29.76|5.39|0.0047
91543253|NCT02528188|182965987|SUPERIORITY||Rate Difference|38.22|||<|0.0001|TWO_SIDED|95.0|23.05|53.4|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||53.40|23.05|<0.0001
91543254|NCT02528188|182965987|SUPERIORITY||Rate Difference|1.94||||0.3214|TWO_SIDED|95.0|-1.89|5.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||5.76|-1.89|0.3214
91543255|NCT02528188|182965987|SUPERIORITY||Rate Difference|12.88||||0.0008|TWO_SIDED|95.0|5.36|20.39|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||20.39|5.36|0.0008
91543256|NCT02528188|182965987|SUPERIORITY||Rate Difference|1.9||||0.5394|TWO_SIDED|95.0|-4.17|7.96|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||7.96|-4.17|0.5394
91543257|NCT02528188|182965987|SUPERIORITY||Rate Difference|2.98||||0.3636|TWO_SIDED|95.0|-3.44|9.39|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||9.39|-3.44|0.3636
91543258|NCT02528188|182965987|SUPERIORITY||Poisson model for rate difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
91543259|NCT02528188|182965987|SUPERIORITY||Rate Difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
91543260|NCT02528188|182965988|SUPERIORITY||Risk Difference (RD)|4.87||||0.0002|TWO_SIDED|95.0|2.43|7.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Exact methods for risk difference|||||7.74|2.43|0.0002
91543261|NCT02528188|182965988|SUPERIORITY||Risk Difference (RD)|9.41|||<|0.0001|TWO_SIDED|95.0|6.73|12.52|||Exact methods for risk difference|||||12.52|6.73|<0.0001
91543262|NCT02528188|182965989|SUPERIORITY||Rate Difference|48.25|||<|0.0001|TWO_SIDED|95.0|26.76|69.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Poisson model for rate difference|||||69.74|26.76|<0.0001
91543263|NCT02528188|182965989|SUPERIORITY||Rate Difference|95.83|||<|0.0001|TWO_SIDED|95.0|70.25|121.42|||Poisson model for rate difference|||||121.42|70.25|<0.0001
91763937|NCT02451514|183418405|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.7|1.25|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.25|0.70|
91543264|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0979|TWO_SIDED|95.0|-0.15|0.01|||ANCOVA|||Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.15|0.0979
91543265|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||ANCOVA|||Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.08|-0.24|<0.0001
91543266|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1162|TWO_SIDED|95.0|-0.17|0.02|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.02|-0.17|0.1162
91543267|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0128|TWO_SIDED|95.0|-0.22|-0.03|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.22|0.0128
91543268|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.8885|TWO_SIDED|95.0|-0.17|0.2|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.20|-0.17|0.8885
91543269|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6345|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.15|-0.24|0.6345
91543270|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4406|TWO_SIDED|95.0|-0.32|0.14|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.14|-0.32|0.4406
91763938|NCT02451514|183418405|OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|95.0|0.91|1.72|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.72|0.91|
91763939|NCT02451514|183418405|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.81|2.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.53|0.81|
91543271|NCT02528188|182965990|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.7109|TWO_SIDED|95.0|-0.19|0.28|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.28|-0.19|0.7109
91543272|NCT02528188|182965991|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.03|-0.30|0.1020
91543273|NCT02528188|182965991|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.023|TWO_SIDED|95.0|-0.35|-0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.35|0.0230
91543274|NCT02528188|182965991|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0645|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.37|0.0645
91543275|NCT02528188|182965991|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5005|TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.13|-0.26|0.5005
91543276|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0358|TWO_SIDED|95.0|1.04|3.29|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||3.29|1.04|0.0358
91763940|NCT02451514|183418405|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|95.0|0.49|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.37|0.49|
91763941|NCT02451514|183418405|OTHER||Geometric mean ratio|1.18|||||TWO_SIDED|95.0|0.67|2.06|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.06|0.67|
91763942|NCT02451514|183418405|OTHER||Geometric mean ratio|1.92|||||TWO_SIDED|95.0|1.33|2.78|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.78|1.33|
91763943|NCT02451514|183418405|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.17|0.61|
91763944|NCT02451514|183418405|OTHER||Geometric mean ratio|1.62|||||TWO_SIDED|95.0|1.13|2.32|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.32|1.13|
91763945|NCT02451514|183418405|OTHER||Geometric mean ratio|7.15|||||TWO_SIDED|95.0|4.25|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||12|4.25|
91543277|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0021|TWO_SIDED|95.0|1.37|4.12|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||4.12|1.37|0.0021
91543278|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0301|TWO_SIDED|95.0|1.07|3.77|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||3.77|1.07|0.0301
91543279|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|2.65||||0.0016|TWO_SIDED|95.0|1.45|4.85|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.85|1.45|0.0016
91543280|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3002|TWO_SIDED|95.0|0.18|1.7|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||1.70|0.18|0.3002
91543281|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8997|TWO_SIDED|95.0|0.39|2.89|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||2.89|0.39|0.8997
91543282|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4559|TWO_SIDED|95.0|0.53|4.18|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.18|0.53|0.4559
91543283|NCT02528188|182965992|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5996|TWO_SIDED|95.0|0.2|2.54|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||2.54|0.20|0.5996
91543284|NCT02528188|182965993|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0714|TWO_SIDED|95.0|0.9|12.65|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.65|0.90|0.0714
91543285|NCT02528188|182965993|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0681|TWO_SIDED|95.0|0.91|12.84|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.84|0.91|0.0681
91543286|NCT02528188|182965993|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0967|TWO_SIDED|95.0|0.81|11.95|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.95|0.81|0.0967
91543287|NCT02528188|182965993|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0976|TWO_SIDED|95.0|0.81|11.9|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.90|0.81|0.0976
91543288|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2212|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.27|0.2212
91543289|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.4557|TWO_SIDED|95.0|-0.1|0.23|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.10|0.4557
91543290|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.09||0.0029|TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.45|0.0029
91543291|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.50|0.0005
91543292|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.09||0.1273|TWO_SIDED|95.0|-0.33|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.33|0.1273
91543293|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.57|-0.2|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.57|<0.0001
91543294|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6349|TWO_SIDED|95.0|-0.31|0.19|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.31|0.6349
91543295|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.13||0.1339|TWO_SIDED|95.0|-0.44|0.06|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.44|0.1339
91763946|NCT02451514|183418405|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.50|0.59|
91543296|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.6237|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6237
91543297|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4224|TWO_SIDED|95.0|-0.37|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.37|0.4224
91543298|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7526|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7526
91543299|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.13||0.7328|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7328
91543300|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5888|TWO_SIDED|95.0|-0.33|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.33|0.5888
91543301|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9345|TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.26|-0.28|0.9345
91543302|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8782|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8782
91543303|NCT02528188|182965994|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7076|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7076
91543304|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|-0.37|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.04|-0.37|0.0150
91543305|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3286|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.25|0.3286
91543306|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0004
91543307|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.53|0.0001
91543308|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0517|TWO_SIDED|95.0|-0.37|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.37|0.0517
91543309|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.61|-0.23|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.61|<0.0001
91543310|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3621|TWO_SIDED|95.0|-0.37|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.37|0.3621
91543311|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0832|TWO_SIDED|95.0|-0.47|0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.47|0.0832
91543312|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4072|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4072
91543313|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.3404|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.39|0.3404
91543314|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6344|TWO_SIDED|95.0|-0.34|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.34|0.6344
91543315|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5756|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.35|0.5756
91543316|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4394|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.38|0.4394
91543317|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7747|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7747
91543318|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7305|TWO_SIDED|95.0|-0.32|0.22|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.32|0.7305
91543319|NCT02528188|182965996|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.733|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7330
91763947|NCT02451514|183418405|OTHER||Geometric mean ratio|6.73|||||TWO_SIDED|95.0|4.03|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||11|4.03|
91763948|NCT02451514|183418405|OTHER||Geometric mean ratio|0.61|||||TWO_SIDED|95.0|0.3|1.23|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||1.23|0.30|
91763949|NCT02451514|183418405|OTHER||Geometric mean ratio|5.53|||||TWO_SIDED|95.0|2.96|10.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||10|2.96|
91543320|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2159|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2159
91543321|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2049|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2049
91543322|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|-0.19|-0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.19|0.0002
91543323|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.21|-0.08|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.21|<0.0001
91543324|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7799|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.08|0.7799
91543325|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0061|TWO_SIDED|95.0|-0.16|-0.03|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.16|0.0061
91543326|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9718|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9718
91543327|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3292|TWO_SIDED|95.0|-0.14|0.05|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.05|-0.14|0.3292
91543328|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.983|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9830
91543329|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.9137|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.9137
91543330|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8784|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.11|0.8784
91543331|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9995|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9995
91543332|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6648|TWO_SIDED|95.0|-0.13|0.08|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.13|0.6648
91543333|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.728|TWO_SIDED|95.0|-0.09|0.12|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.09|0.7280
91543334|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8856|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.8856
91543335|NCT02528188|182965998|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2814|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.05|0.2814
91543336|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4691|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.28|0.89|0.4691
91543337|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5451|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.13|0.79|0.5451
91543338|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0059|TWO_SIDED|95.0|1.08|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.54|1.08|0.0059
91543339|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0057|TWO_SIDED|95.0|1.08|1.55|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.55|1.08|0.0057
91543340|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1584|TWO_SIDED|95.0|0.95|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.38|0.95|0.1584
91543341|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.3||||0.006||95.0|1.08|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.58|1.08|0.0060
91543342|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1117|TWO_SIDED|95.0|0.96|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.46|0.96|0.1117
91543343|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1004|TWO_SIDED|95.0|0.97|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.47|0.97|0.1004
91543344|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6258|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.25|0.87|0.6258
91543345|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.16||||0.1154|TWO_SIDED|95.0|0.96|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.39|0.96|0.1154
91543346|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8018|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.22|0.86|0.8018
91543347|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5697|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.26|0.88|0.5697
91543348|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9557|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.20|0.84|0.9557
91543349|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8553|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.22|0.85|0.8553
91543350|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9901|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.20|0.84|0.9901
91543351|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|0.95||||0.587|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.14|0.80|0.5870
91543352|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8302|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.22|0.85|0.8302
91543353|NCT02528188|182966000|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4823|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.12|0.79|0.4823
91543354|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.11||||0.2938|TWO_SIDED|95.0|0.92|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.33|0.92|0.2938
91543355|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.91||||0.3146|TWO_SIDED|95.0|0.75|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.10|0.75|0.3146
91543356|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0748|TWO_SIDED|95.0|0.98|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.58|0.98|0.0748
91543357|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.45|0.89|0.3000
91543358|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.23||||0.255|TWO_SIDED|95.0|0.86|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.74|0.86|0.2550
91543359|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.14||||0.478|TWO_SIDED|95.0|0.8|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.62|0.80|0.4780
91543360|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4006|TWO_SIDED|95.0|0.7|2.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.42|0.70|0.4006
91543361|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3089|TWO_SIDED|95.0|0.74|2.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.54|0.74|0.3089
91543362|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0114|TWO_SIDED|95.0|1.05|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.50|1.05|0.0114
91543363|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.23||||0.0239|TWO_SIDED|95.0|1.03|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.47|1.03|0.0239
91543364|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0079|TWO_SIDED|95.0|1.07|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.07|0.0079
91543365|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0068|TWO_SIDED|95.0|1.08|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.08|0.0068
91543366|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1037|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.62|0.96|0.1037
91543367|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0046|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.12|0.0046
91543368|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1971|TWO_SIDED|95.0|0.85|2.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.19|0.85|0.1971
91543369|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.59||||0.048|TWO_SIDED|95.0|1.0|2.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.52|1.00|0.0480
91543370|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4744|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.28|0.89|0.4744
91543371|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0336|TWO_SIDED|95.0|1.02|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.45|1.02|0.0336
91543372|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.2||||0.0559|TWO_SIDED|95.0|1.0|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.44|1.00|0.0559
91543373|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0021|TWO_SIDED|95.0|1.11|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.61|1.11|0.0021
91543374|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0535|TWO_SIDED|95.0|1.0|1.59|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.59|1.00|0.0535
91543375|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0003|TWO_SIDED|95.0|1.22|1.92|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.92|1.22|0.0003
91543376|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.11||||0.6421|TWO_SIDED|95.0|0.72|1.7|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||1.70|0.72|0.6421
91543377|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0207|TWO_SIDED|95.0|1.07|2.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||2.38|1.07|0.0207
91543378|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1635|TWO_SIDED|95.0|0.95|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.39|0.95|0.1635
91543379|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0529|TWO_SIDED|95.0|1.0|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.47|1.00|0.0529
91543380|NCT02528188|182966001|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.15||||0.1322|TWO_SIDED|95.0|0.96|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.37|0.96|0.1322
91543381|NCT02528188|182966001|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.22||||0.0262|TWO_SIDED|95.0|1.02|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.46|1.02|0.0262
91543382|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9805|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.22|0.83|0.9805
91543383|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0033|TWO_SIDED|95.0|1.1|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.61|1.10|0.0033
91543384|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.24||||0.159|TWO_SIDED|95.0|0.92|1.69|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||1.69|0.92|0.1590
91543385|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0024|TWO_SIDED|95.0|1.17|2.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||2.11|1.17|0.0024
91543386|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.20|0.83|0.9932
91543387|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4374|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.29|0.90|0.4374
91543388|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4406|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.28|0.90|0.4406
91543389|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4078|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.29|0.90|0.4078
91543390|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4071|TWO_SIDED|95.0|0.89|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.31|0.89|0.4071
91543391|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0248|TWO_SIDED|95.0|1.03|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.50|1.03|0.0248
91543392|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.88||||0.3641|TWO_SIDED|95.0|0.66|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.16|0.66|0.3641
91543393|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2497|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.53|0.89|0.2497
91543394|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8682|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.21|0.85|0.8682
91543395|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7317|TWO_SIDED|95.0|0.81|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.16|0.81|0.7317
91543396|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6493|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6493
91543397|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.98||||0.7973|TWO_SIDED|95.0|0.82|1.17|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.17|0.82|0.7973
91543398|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0757|TWO_SIDED|95.0|0.98|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.45|0.98|0.0757
91543399|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0578|TWO_SIDED|95.0|0.99|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.47|0.99|0.0578
91543400|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.76|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.37|0.76|0.9010
91543401|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0548|TWO_SIDED|95.0|0.99|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.74|0.99|0.0548
91543402|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7331|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.23|0.86|0.7331
91543403|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.98||||0.8632|TWO_SIDED|95.0|0.82|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.18|0.82|0.8632
91543404|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6262|TWO_SIDED|95.0|0.88|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.25|0.88|0.6262
91543405|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6817|TWO_SIDED|95.0|0.81|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.15|0.81|0.6817
91543406|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.03||||0.799|TWO_SIDED|95.0|0.85|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.24|0.85|0.7990
91543407|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6786|TWO_SIDED|95.0|0.86|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.26|0.86|0.6786
91543408|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8069|TWO_SIDED|95.0|0.78|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.38|0.78|0.8069
91543409|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2951|TWO_SIDED|95.0|0.88|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.54|0.88|0.2951
91543410|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9093|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.21|0.85|0.9093
91763950|NCT02451514|183418405|OTHER||Geometric mean ratio|3.38|||||TWO_SIDED|95.0|1.7|6.73|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||6.73|1.70|
91763951|NCT02451514|183418405|OTHER||Geometric mean ratio|2.58|||||TWO_SIDED|95.0|1.2|5.54|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||5.54|1.20|
91763952|NCT02451514|183418405|OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|95.0|0.66|2.56|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.56|0.66|
91763953|NCT02451514|183418405|OTHER||Geometric mean ratio|3.34|||||TWO_SIDED|95.0|1.57|7.11|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||7.11|1.57|
91543411|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5032|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5032
91543412|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4382|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4382
91543413|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5638|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.13|0.79|0.5638
91543414|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6436|TWO_SIDED|95.0|0.86|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.27|0.86|0.6436
91543415|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.04||||0.706|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.26|0.85|0.7060
91543416|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7729|TWO_SIDED|95.0|0.72|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.28|0.72|0.7729
91543417|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6405|TWO_SIDED|95.0|0.81|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.42|0.81|0.6405
91543418|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9046|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.21|0.85|0.9046
91543419|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.93||||0.4491|TWO_SIDED|95.0|0.78|1.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.11|0.78|0.4491
91543420|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7429|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.23|0.86|0.7429
91543421|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3467|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.10|0.77|0.3467
91543422|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.85|0.7624
91543423|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7686|TWO_SIDED|95.0|0.8|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.18|0.80|0.7686
91543424|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9384|TWO_SIDED|95.0|0.74|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.33|0.74|0.9384
91543425|NCT02528188|182966001|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8495|TWO_SIDED|95.0|0.77|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.38|0.77|0.8495
91543426|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0651|TWO_SIDED|95.0|0.99|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.44|0.99|0.0651
91543427|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9032|TWO_SIDED|95.0|0.84|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.22|0.84|0.9032
91543428|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.36||||0.01|TWO_SIDED|95.0|1.08|1.72|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.72|1.08|0.0100
91543429|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.12||||0.3728|TWO_SIDED|95.0|0.88|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.42|0.88|0.3728
91543430|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0434|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0434
91543431|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0425|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0425
91543432|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5442|TWO_SIDED|95.0|0.64|2.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||2.34|0.64|0.5442
91543433|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0349|TWO_SIDED|95.0|1.05|3.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||3.45|1.05|0.0349
91543434|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0108|TWO_SIDED|95.0|1.05|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.51|1.05|0.0108
91543435|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.27||||0.008|TWO_SIDED|95.0|1.07|1.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.52|1.07|0.0080
91543436|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.83|1.22|<0.0001
91543437|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.24|1.85|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.85|1.24|<0.0001
91543438|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.45||||0.006|TWO_SIDED|95.0|1.11|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.11|0.0060
91543439|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0031|TWO_SIDED|95.0|1.14|1.93|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.93|1.14|0.0031
91543440|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0235|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||2.88|1.08|0.0235
91543441|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0021|TWO_SIDED|95.0|1.31|3.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||3.42|1.31|0.0021
91543442|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7613|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.23|0.86|0.7613
91543443|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0548|TWO_SIDED|95.0|1.0|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.43|1.00|0.0548
91543444|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0196|TWO_SIDED|95.0|1.04|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.51|1.04|0.0196
91543445|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.2|1.75|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.75|1.20|<0.0001
91543446|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0077||95.0|1.09|1.77|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||1.77|1.09|0.0077
91543447|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.3|2.09|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||2.09|1.30|<0.0001
91543448|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1942|TWO_SIDED|95.0|0.87|1.96|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||1.96|0.87|0.1942
91543449|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0122|TWO_SIDED|95.0|1.11|2.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||2.43|1.11|0.0122
91543450|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.18||||0.0977|TWO_SIDED|95.0|0.97|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.43|0.97|0.0977
91543451|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0806|TWO_SIDED|95.0|0.98|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.44|0.98|0.0806
91543452|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2097|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.34|0.94|0.2097
91543453|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0135|TWO_SIDED|95.0|1.05|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.49|1.05|0.0135
91543454|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.1||||0.3571|TWO_SIDED|95.0|0.9|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.33|0.90|0.3571
91543455|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0025|TWO_SIDED|95.0|1.11|1.63|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.63|1.11|0.0025
91543456|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4658|TWO_SIDED|95.0|0.83|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.49|0.83|0.4658
91543457|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0108|TWO_SIDED|95.0|1.09|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.90|1.09|0.0108
91543458|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8393|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.22|0.85|0.8393
91543459|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2977|TWO_SIDED|95.0|0.92|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.32|0.92|0.2977
91543460|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.12||||0.1944|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.34|0.94|0.1944
91543461|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5714|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.26|0.88|0.5714
91543462|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2472|TWO_SIDED|95.0|0.92|1.36|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.36|0.92|0.2472
91543463|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0235|TWO_SIDED|95.0|1.03|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.51|1.03|0.0235
91543464|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4074|TWO_SIDED|95.0|0.85|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.51|0.85|0.4074
91543465|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0296|TWO_SIDED|95.0|1.03|1.81|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.81|1.03|0.0296
91543466|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7607|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.23|0.86|0.7607
91543467|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.02||||0.7979|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.22|0.86|0.7979
91543468|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2964|TWO_SIDED|95.0|0.92|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.31|0.92|0.2964
91543469|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.04||||0.695|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6950
91543470|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1985|TWO_SIDED|95.0|0.93|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.38|0.93|0.1985
91543471|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.17||||0.1239|TWO_SIDED|95.0|0.96|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.42|0.96|0.1239
91543472|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2762|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.58|0.88|0.2762
91543473|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0121|TWO_SIDED|95.0|1.08|1.91|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.91|1.08|0.0121
91543474|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8443|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8443
91543475|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8472|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8472
91543476|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.01||||0.898|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.21|0.85|0.8980
91543477|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.19|0.83|0.9385
91543478|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4261|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.32|0.89|0.4261
91543479|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.07||||0.525|TWO_SIDED|95.0|0.88|1.3|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.30|0.88|0.5250
91543480|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6273|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.45|0.80|0.6273
91543481|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0132|TWO_SIDED|95.0|1.08|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.90|1.08|0.0132
91543482|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9095|TWO_SIDED|95.0|0.83|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.18|0.83|0.9095
91543483|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5098|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5098
91543484|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4488|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4488
91543485|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9757|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.19|0.83|0.9757
91543486|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1843|TWO_SIDED|95.0|0.94|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.39|0.94|0.1843
91543487|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4356|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.32|0.89|0.4356
91543488|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6342|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.45|0.80|0.6342
91543489|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.29||||0.081|TWO_SIDED|95.0|0.97|1.73|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.73|0.97|0.0810
91543490|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6527|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.15|0.80|0.6527
91543491|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3857|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.10|0.77|0.3857
91543492|NCT02528188|182966003|SUPERIORITY||Odds Ratio, log|1.06||||0.528|TWO_SIDED|95.0|0.89|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.27|0.89|0.5280
91543493|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5355|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.13|0.79|0.5355
91543494|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7732|TWO_SIDED|95.0|0.84|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.84|0.7732
91543495|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9397|TWO_SIDED|95.0|0.82|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.23|0.82|0.9397
91543496|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9044|TWO_SIDED|95.0|0.75|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.39|0.75|0.9044
91543497|NCT02528188|182966003|SUPERIORITY||Odds Ratio (OR)|1.16||||0.3193|TWO_SIDED|95.0|0.86|1.57|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.57|0.86|0.3193
91543498|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1772|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.62|0.91|0.1772
91543499|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0154|TWO_SIDED|95.0|1.07|1.89|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.89|1.07|0.0154
91543500|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0105|TWO_SIDED|95.0|1.08|1.81|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.81|1.08|0.0105
91543501|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0002|TWO_SIDED|95.0|1.26|2.1|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||2.10|1.26|0.0002
91543502|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4007|TWO_SIDED|95.0|0.87|1.43|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.43|0.87|0.4007
91543503|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0116|TWO_SIDED|95.0|1.07|1.75|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.75|1.07|0.0116
91543504|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6279|TWO_SIDED|95.0|0.76|1.18|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.18|0.76|0.6279
91543505|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4674|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.35|0.87|0.4674
91543506|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3135|TWO_SIDED|95.0|0.71|1.12|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.71|0.3135
91543507|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7581|TWO_SIDED|95.0|0.83|1.3|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.30|0.83|0.7581
91543508|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.92||||0.4504|TWO_SIDED|95.0|0.73|1.15|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.73|0.4504
91543509|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.88||||0.2629|TWO_SIDED|95.0|0.7|1.1|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.10|0.70|0.2629
91543510|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6763|TWO_SIDED|95.0|0.75|1.2|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.75|0.6763
91543511|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9456|TWO_SIDED|95.0|0.8|1.27|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.27|0.80|0.9456
91543512|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.96||||0.752|TWO_SIDED|95.0|0.76|1.22|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.76|0.7520
91543513|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9981|TWO_SIDED|95.0|0.79|1.26|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.79|0.9981
91543514|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5284|TWO_SIDED|95.0|0.74|1.17|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.17|0.74|0.5284
91543515|NCT02528188|182966005|SUPERIORITY||Odds Ratio (OR)|0.89||||0.322|TWO_SIDED|95.0|0.7|1.12|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.70|0.3220
91543516|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.112|TWO_SIDED|95.0|-0.02|0.2|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.20|-0.02|0.1120
91543517|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9686|TWO_SIDED|95.0|-0.11|0.11|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.11|-0.11|0.9686
91543518|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.1589|TWO_SIDED|95.0|-0.25|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.25|0.1589
91543519|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.472|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.09|-0.20|0.4720
91543520|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.01|-0.33|0.0320
91543521|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3336|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.24|0.3336
91543522|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.47|-0.13|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.47|0.0005
91543523|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.5|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.50|0.0001
91543524|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.55|<0.0001
91543525|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.66|<0.0001
91543526|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0115|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.42|0.0115
91543527|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.26|-0.63|<0.0001
91543528|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.17|-0.56|0.0002
91543529|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.28|-0.67|<0.0001
91543530|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.57|0.0002
91543531|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.64|-0.25|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.64|<0.0001
91543532|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0238|TWO_SIDED|95.0|-0.44|-0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.03|-0.44|0.0238
91543533|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0011|TWO_SIDED|95.0|-0.55|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.14|-0.55|0.0011
91543534|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0064|TWO_SIDED|95.0|-0.51|-0.08|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.08|-0.51|0.0064
91543535|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0025|TWO_SIDED|95.0|-0.54|-0.12|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.12|-0.54|0.0025
91543536|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0589|TWO_SIDED|95.0|-0.48|0.01|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.01|-0.48|0.0589
91543537|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.018|TWO_SIDED|95.0|-0.53|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.53|0.0180
91543538|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0944|TWO_SIDED|95.0|-0.47|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.47|0.0944
91543539|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1198|TWO_SIDED|95.0|-0.45|0.05|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.05|-0.45|0.1198
91543540|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1837|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1837
91543541|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.317|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.13|-0.39|0.3170
91543542|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1873|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1873
91543543|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5719|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.18|-0.33|0.5719
91543544|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3571|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.14|-0.39|0.3571
91763954|NCT02451514|183418405|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.51|2.59|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||2.59|0.51|
91543545|NCT02528188|182966006|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9072|TWO_SIDED|95.0|-0.25|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.28|-0.25|0.9072
91543546|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.49|0.0004
91543547|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0134|TWO_SIDED|95.0|-0.4|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.40|0.0134
91543548|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-0.56|<0.0001
91543549|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.29|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-0.67|<0.0001
91543550|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0031|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.10|-0.49|0.0031
91543551|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.43|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-0.82|<0.0001
91543552|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0425|TWO_SIDED|95.0|-0.43|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.43|0.0425
91543553|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.65|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.65|<0.0001
91543554|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.298|TWO_SIDED|95.0|-0.4|0.12|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.40|0.2980
91543555|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0179|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.58|0.0179
91543556|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.2328|TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.42|0.2328
91763955|NCT02451514|183418405|OTHER||Geometric mean ratio|2.93|||||TWO_SIDED|95.0|1.4|6.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||6.12|1.40|
91763956|NCT02451514|183418405|OTHER||Geometric mean ratio|3.35|||||TWO_SIDED|95.0|1.49|7.57|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||7.57|1.49|
91763957|NCT02451514|183418405|OTHER||Geometric mean ratio|0.52|||||TWO_SIDED|95.0|0.23|1.18|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.18|0.23|
91763958|NCT02451514|183418405|OTHER||Geometric mean ratio|5.94|||||TWO_SIDED|95.0|2.84|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||12|2.84|
91763959|NCT02451514|183418405|OTHER||Geometric mean ratio|3.09|||||TWO_SIDED|95.0|1.38|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||6.92|1.38|
91543557|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.1019|TWO_SIDED|95.0|-0.49|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.49|0.1019
91543558|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4002|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4002
91543559|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2149|TWO_SIDED|95.0|-0.45|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.45|0.2149
91543560|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2442|TWO_SIDED|95.0|-0.43|0.11|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.43|0.2442
91543561|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4609|TWO_SIDED|95.0|-0.37|0.17|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.37|0.4609
91543562|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8129|TWO_SIDED|95.0|-0.31|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.31|0.8129
91543563|NCT02528188|182966008|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7883|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.32|0.7883
91543564|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.0119|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.37|0.0119
91543565|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3073|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.24|0.3073
91543566|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0002
91543567|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.56|<0.0001
91763960|NCT02451514|183418409|OTHER||Geometric mean ratio|8.5|||||TWO_SIDED|95.0|4.41|16.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||16|4.41|
91763961|NCT02451514|183418409|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|95.0|0.39|1.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.27|0.39|
91763962|NCT02451514|183418409|OTHER||Geometric mean ratio|5.97|||||TWO_SIDED|95.0|3.14|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||11|3.14|
91763963|NCT02451514|183418409|OTHER||Geometric mean ratio|197.0|||||TWO_SIDED|95.0|86.0|452.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||452|86|
91543568|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.0251|TWO_SIDED|95.0|-0.39|-0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.39|0.0251
91543569|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-0.66|<0.0001
91543570|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0625|TWO_SIDED|95.0|-0.39|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.01|-0.39|0.0625
91543571|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.54|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.54|0.0010
91543572|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4005|TWO_SIDED|95.0|-0.36|0.14|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.14|-0.36|0.4005
91543573|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.053|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.50|0.0530
91543574|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4074|TWO_SIDED|95.0|-0.37|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.37|0.4074
91543575|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2629|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2629
91543576|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5582|TWO_SIDED|95.0|-0.34|0.18|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.18|-0.34|0.5582
91543577|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4907|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.35|0.4907
91543578|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4043|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4043
91543579|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7663|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7663
91543580|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7415|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7415
91763964|NCT02451514|183418409|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|95.0|0.47|2.07|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.07|0.47|
91763965|NCT02451514|183418409|OTHER||Geometric mean ratio|193.0|||||TWO_SIDED|95.0|84.0|442.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||442|84|
91543581|NCT02528188|182966010|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8688|TWO_SIDED|95.0|-0.24|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.24|0.8688
91543582|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.3622|TWO_SIDED|95.0|-0.25|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.25|0.3622
91543583|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.3894|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.09|0.3894
91543584|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.0137|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.42|0.0137
91543585|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0106|TWO_SIDED|95.0|-0.43|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.43|0.0106
91543586|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7179|TWO_SIDED|95.0|-0.23|0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.23|0.7179
91543587|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.44|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.44|0.0120
91543588|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.11||0.5372|TWO_SIDED|95.0|-0.28|0.15|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.28|0.5372
91543589|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0899|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.40|0.0899
91543590|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7646|TWO_SIDED|95.0|-0.3|0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.30|0.7646
91543591|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2547|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2547
91543592|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8806|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8806
91543593|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8416|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8416
91543594|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.9981|TWO_SIDED|95.0|-0.28|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.28|-0.28|0.9981
91543595|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6485|TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.34|-0.21|0.6485
91543596|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8317|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8317
91543597|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5819|TWO_SIDED|95.0|-0.19|0.35|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.35|-0.19|0.5819
91543598|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8538|TWO_SIDED|95.0|-0.26|0.31|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.31|-0.26|0.8538
91543599|NCT02528188|182966012|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.15||0.1981|TWO_SIDED|95.0|-0.1|0.47|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.47|-0.10|0.1981
91543600|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0846|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.33|0.0846
91543601|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9749|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.18|0.9749
91543602|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0076|TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.45|0.0076
91543603|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-0.54|0.0003
91543604|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.4402|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.27|0.4402
91543605|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.61|<0.0001
91763966|NCT02451514|183418409|OTHER||Geometric mean ratio|3.51|||||TWO_SIDED|95.0|1.96|6.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||6.27|1.96|
91763967|NCT02451514|183418409|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|95.0|0.37|1.0|||Mixed Models Analysis|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.0|0.37|
91763968|NCT02451514|183418409|OTHER||Geometric mean ratio|2.17|||||TWO_SIDED|95.0|1.23|3.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||3.85|1.23|
91543606|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1543|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.38|0.1543
91543607|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.53|0.0053
91543608|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6445|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6445
91543609|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1439|TWO_SIDED|95.0|-0.47|0.07|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.07|-0.47|0.1439
91543610|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8402|TWO_SIDED|95.0|-0.3|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.30|0.8402
91543611|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4439|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.38|0.4439
91543612|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9376|TWO_SIDED|95.0|-0.27|0.29|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.27|0.9376
91543613|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7614|TWO_SIDED|95.0|-0.33|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.33|0.7614
91543614|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8081|TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.32|0.8081
91543615|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8078|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.33|-0.25|0.8078
91543616|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9705|TWO_SIDED|95.0|-0.28|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.28|0.9705
91763969|NCT02451514|183418409|OTHER||Geometric mean ratio|3.57|||||TWO_SIDED|95.0|1.84|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||6.92|1.84|
91763970|NCT02451514|183418409|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|95.0|0.4|1.29|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.29|0.40|
91763971|NCT02451514|183418409|OTHER||Geometric mean ratio|2.55|||||TWO_SIDED|95.0|1.33|4.89|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||4.89|1.33|
91763972|NCT02451514|183418409|OTHER||Geometric mean ratio|17.0|||||TWO_SIDED|95.0|8.18|35.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||35|8.18|
91763973|NCT02451514|183418409|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.41|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.53|0.41|
91543617|NCT02528188|182966014|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.5785|TWO_SIDED|95.0|-0.21|0.38|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.38|-0.21|0.5785
91543618|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.74||0.4303|TWO_SIDED|95.0|-0.87|2.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.04|-0.87|0.4303
91543619|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.75||0.5656|TWO_SIDED|95.0|-1.9|1.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.04|-1.90|0.5656
91543620|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.92||0.976|TWO_SIDED|95.0|-1.78|1.83|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.83|-1.78|0.9760
91543621|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.5678|TWO_SIDED|95.0|-1.3|2.36|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.36|-1.30|0.5678
91543622|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|1.76||0.6974|TWO_SIDED|95.0|-2.77|4.14|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.14|-2.77|0.6974
91543623|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|2.64|STANDARD_ERROR_OF_MEAN|1.72||0.1261|TWO_SIDED|95.0|-0.75|6.04|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.04|-0.75|0.1261
91543624|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.78||0.406|TWO_SIDED|95.0|-4.96|2.01|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.01|-4.96|0.4060
91543625|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.78||0.848|TWO_SIDED|95.0|-3.84|3.15|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.15|-3.84|0.8480
91543626|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|1.94||0.923|TWO_SIDED|95.0|-4.0|3.63|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.63|-4.00|0.9230
91543627|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.96||0.4421|TWO_SIDED|95.0|-5.36|2.34|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.34|-5.36|0.4421
91543628|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.44||0.2049|TWO_SIDED|95.0|-1.7|7.91|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||7.91|-1.70|0.2049
91543629|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|4.68|STANDARD_ERROR_OF_MEAN|2.4||0.0527|TWO_SIDED|95.0|-0.05|9.41|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||9.41|-0.05|0.0527
91543630|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.82||0.3699|TWO_SIDED|95.0|-5.21|1.94|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.94|-5.21|0.3699
91543631|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.83||0.7945|TWO_SIDED|95.0|-4.06|3.11|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.11|-4.06|0.7945
91543632|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|2.03||0.941|TWO_SIDED|95.0|-4.13|3.83|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.83|-4.13|0.9410
91543633|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.05||0.486|TWO_SIDED|95.0|-5.44|2.59|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.59|-5.44|0.4860
91543634|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|2.62||0.2448|TWO_SIDED|95.0|-2.1|8.2|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||8.20|-2.10|0.2448
91543635|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|4.96|STANDARD_ERROR_OF_MEAN|2.58||0.0551|TWO_SIDED|95.0|-0.11|10.04|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||10.04|-0.11|0.0551
91543636|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|1.05||0.247|TWO_SIDED|95.0|-3.26|0.84|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.84|-3.26|0.2470
91543637|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|1.04||0.057|TWO_SIDED|95.0|-4.01|0.06|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.06|-4.01|0.0570
91543638|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.917|TWO_SIDED|95.0|-2.36|2.12|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.12|-2.36|0.9170
91543639|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.14||0.4991|TWO_SIDED|95.0|-3.0|1.46|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.46|-3.00|0.4991
91543640|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.44||0.2377|TWO_SIDED|95.0|-1.12|4.52|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.52|-1.12|0.2377
91543641|NCT02528188|182966016|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.44||0.0238|TWO_SIDED|95.0|0.43|6.08|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.08|0.43|0.0238
91543642|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.08||0.0142|TWO_SIDED|95.0|0.53|4.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.78|0.53|0.0142
91543643|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|2.56|6.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||6.78|2.56|<0.0001
91543644|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.45||0.1371|TWO_SIDED|95.0|-0.69|4.99|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.99|-0.69|0.1371
91543645|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.46||0.8524|TWO_SIDED|95.0|-2.6|3.14|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.14|-2.60|0.8524
91543646|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|3.8||0.5253|TWO_SIDED|95.0|-9.93|5.09|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.09|-9.93|0.5253
91543647|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|3.71||0.5381|TWO_SIDED|95.0|-5.04|9.62|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||9.62|-5.04|0.5381
91543648|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|7.27|STANDARD_ERROR_OF_MEAN|6.44||0.2694|TWO_SIDED|95.0|-5.99|20.54|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||20.54|-5.99|0.2694
91543649|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|-9.34|STANDARD_ERROR_OF_MEAN|6.05||0.1349|TWO_SIDED|95.0|-21.8|3.11|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.11|-21.80|0.1349
91763974|NCT02451514|183418409|OTHER||Geometric mean ratio|13.0|||||TWO_SIDED|95.0|6.59|28.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||28|6.59|
91543650|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.0264|TWO_SIDED|95.0|0.21|3.38|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.38|0.21|0.0264
91543651|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.8||0.0098|TWO_SIDED|95.0|0.5|3.65|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.65|0.50|0.0098
91543652|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.1||0.0937|TWO_SIDED|95.0|-0.31|4.01|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.01|-0.31|0.0937
91543653|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.11||0.1838|TWO_SIDED|95.0|-0.7|3.67|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.67|-0.70|0.1838
91543654|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.05||0.0025|TWO_SIDED|95.0|1.12|5.25|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.25|1.12|0.0025
91543655|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|1.04||0.0007|TWO_SIDED|95.0|1.51|5.6|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.60|1.51|0.0007
91543656|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|1.31||0.1373|TWO_SIDED|95.0|-0.62|4.51|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.51|-0.62|0.1373
91543657|NCT02528188|182966024|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|1.32||0.996|TWO_SIDED|95.0|-2.59|2.6|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||2.60|-2.59|0.9960
91543658|NCT02528188|182966026|SUPERIORITY|||||||0.0823|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0823
91543659|NCT02528188|182966026|SUPERIORITY|||||||0.0049|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0049
91543660|NCT02528188|182966026|SUPERIORITY|||||||0.0718|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0718
91543661|NCT02528188|182966026|SUPERIORITY|||||||0.1947|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1947
91543662|NCT02528188|182966027|SUPERIORITY|||||||0.0229|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0229
91543663|NCT02528188|182966027|SUPERIORITY|||||||0.0029|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0029
91543664|NCT02528188|182966027|SUPERIORITY|||||||0.0266|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0266
91543665|NCT02528188|182966027|SUPERIORITY|||||||0.1835|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1835
91763975|NCT02451514|183418409|OTHER||Geometric mean ratio|74.0|||||TWO_SIDED|95.0|34.0|160.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||160|34|
91763976|NCT02451514|183418409|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.38|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.53|0.38|
91763977|NCT02451514|183418409|OTHER||Geometric mean ratio|57.0|||||TWO_SIDED|95.0|27.0|121.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||121|27|
91763978|NCT02451514|183418409|OTHER||Geometric mean ratio|2.66|||||TWO_SIDED|95.0|1.46|4.83|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||4.83|1.46|
91763979|NCT02451514|183418409|OTHER||Geometric mean ratio|6.76|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||12|3.96|
91763980|NCT02451514|183418409|OTHER||Geometric mean ratio|18.0|||||TWO_SIDED|95.0|10.0|32.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||32|10|
91763981|NCT02451514|183418409|OTHER||Geometric mean ratio|1.4|||||TWO_SIDED|95.0|0.72|2.71|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.71|0.72|
91763982|NCT02451514|183418409|OTHER||Geometric mean ratio|21.0|||||TWO_SIDED|95.0|12.0|37.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||37|12|
91763983|NCT02451514|183418409|OTHER||Geometric mean ratio|29.0|||||TWO_SIDED|95.0|15.0|55.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||55|15|
91763984|NCT02451514|183418409|OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|95.0|0.47|1.38|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||1.38|0.47|
91763985|NCT02451514|183418409|OTHER||Geometric mean ratio|19.0|||||TWO_SIDED|95.0|12.0|31.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||31|12|
91763986|NCT02451514|183418409|OTHER||Geometric mean ratio|16.0|||||TWO_SIDED|95.0|9.27|26.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||26|9.27|
91763987|NCT02451514|183418409|OTHER||Geometric mean ratio|0.46|||||TWO_SIDED|95.0|0.17|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.28|0.17|
91763988|NCT02451514|183418409|OTHER||Geometric mean ratio|20.0|||||TWO_SIDED|95.0|8.2|48.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||48|8.20|
91763989|NCT02451514|183418409|OTHER||Geometric mean ratio|9.13|||||TWO_SIDED|95.0|3.78|22.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||22|3.78|
91763990|NCT02451514|183418422|OTHER||Geometric mean ratio|0.49|||||TWO_SIDED|95.0|0.28|0.87|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M14459||0.87|0.28|
91763991|NCT02451514|183418422|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.4|2.11|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M01-0240364||2.11|0.40|
91763992|NCT02451514|183418422|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|95.0|0.5|1.38|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, NZ98/254||1.38|0.50|
91763993|NCT02451514|183418422|OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.44|1.44|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, M10713||1.44|0.44|
91763994|NCT02451514|183418422|OTHER||Geometric mean ratio|0.6|||||TWO_SIDED|95.0|0.34|1.07|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, H44/76||1.07|0.34|
91763995|NCT02451514|183418422|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.52|1.12|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, 5/99||1.12|0.52|
91763996|NCT02451514|183418422|OTHER||Geometric mean ratio|2.99|||||TWO_SIDED|95.0|1.89|4.75|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup A||4.75|1.89|
91763997|NCT02451514|183418422|OTHER||Geometric mean ratio|4.69|||||TWO_SIDED|95.0|3.01|7.31|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup C||7.31|3.01|
91763998|NCT02451514|183418422|OTHER||Geometric mean ratio|8.6|||||TWO_SIDED|95.0|5.84|13.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup W||13|5.84|
91763999|NCT02451514|183418422|OTHER||Geometric mean ratio|7.03|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup Y||12|3.96|
91764000|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for each serotype 1, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.05|0.88|
91764001|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.81|0.69|
91764002|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.26|0.96|
91543666|NCT02528188|182966028|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0076|TWO_SIDED|95.0|0.45|0.88|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.88|0.45|0.0076
91543667|NCT02528188|182966028|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0187|TWO_SIDED|95.0|0.48|0.94|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.94|0.48|0.0187
91543668|NCT02528188|182966029|SUPERIORITY|||||||0.0074|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0074
91543669|NCT02528188|182966029|SUPERIORITY|||||||0.0162|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0162
91543670|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1136|TWO_SIDED|95.0|0.97|1.38|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.38|0.97|0.1136
91543671|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.08||||0.391|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.29|0.90|0.3910
91543672|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7691|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.86|0.7691
91543673|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.88||||0.143|TWO_SIDED|95.0|0.73|1.05|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.05|0.73|0.1430
91543674|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6454|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.25|0.87|0.6454
91543675|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.84||||0.0561|TWO_SIDED|95.0|0.7|1.0|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.00|0.70|0.0561
91543676|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9056|TWO_SIDED|95.0|0.82|1.19|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.82|0.9056
91543677|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2919|TWO_SIDED|95.0|0.75|1.09|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.09|0.75|0.2919
91543678|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4976|TWO_SIDED|95.0|0.78|1.13|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.13|0.78|0.4976
91543679|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2425|TWO_SIDED|95.0|0.75|1.08|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.08|0.75|0.2425
91543680|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9242|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9242
91543681|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6621|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.80|0.6621
91543682|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9977|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.83|0.9977
91543683|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9762|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.84|0.9762
91543684|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9718|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9718
91543685|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8219|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.85|0.8219
91543686|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6936|TWO_SIDED|95.0|0.8|1.16|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.16|0.80|0.6936
91543687|NCT02528188|182966030|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5769|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.88|0.5769
91543688|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.07||0.7746|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.7746
91543689|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.07||0.8441|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.8441
91543690|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.08||0.658|TWO_SIDED|95.0|0.83|1.13|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.83|0.6580
91543691|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.07||0.2279|TWO_SIDED|95.0|0.78|1.06|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.06|0.78|0.2279
91543692|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.09||0.9986|TWO_SIDED|95.0|0.84|1.18|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.84|0.9986
91543693|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.07||0.0771|TWO_SIDED|95.0|0.72|1.02|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.02|0.72|0.0771
91543694|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.09||0.4485|TWO_SIDED|95.0|0.77|1.13|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.77|0.4485
91543695|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.2817|TWO_SIDED|95.0|0.74|1.09|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.09|0.74|0.2817
91543696|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5426|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5426
91543697|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5385|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5385
91543698|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5041|TWO_SIDED|95.0|0.79|1.12|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.12|0.79|0.5041
91543699|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.08||0.441|TWO_SIDED|95.0|0.78|1.11|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.78|0.4410
91543700|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7426|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7426
91543701|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7469|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7469
91543702|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.09||0.6784|TWO_SIDED|95.0|0.81|1.15|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.81|0.6784
91543703|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.09||0.8822|TWO_SIDED|95.0|0.85|1.21|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.21|0.85|0.8822
91543704|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.09||0.9119|TWO_SIDED|95.0|0.83|1.18|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.83|0.9119
91543705|NCT02528188|182966032|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5148|TWO_SIDED|95.0|0.89|1.26|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.26|0.89|0.5148
91543706|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3348|TWO_SIDED|95.0|0.66|1.15|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.66|0.3348
91543707|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.13||0.3595|TWO_SIDED|95.0|0.66|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.66|0.3595
91543708|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.0854|TWO_SIDED|95.0|0.54|1.04|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.04|0.54|0.0854
91543709|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.12||0.0281|TWO_SIDED|95.0|0.5|0.96|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.96|0.50|0.0281
91543710|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.13||0.0595|TWO_SIDED|95.0|0.49|1.01|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.01|0.49|0.0595
91543711|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.57|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.4|0.83|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.83|0.40|0.0030
91543712|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.15||0.1389|TWO_SIDED|95.0|0.48|1.11|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.48|0.1389
91543713|NCT02528188|182966034|SUPERIORITY||LS Mean Ratio|0.68|STANDARD_ERROR_OF_MEAN|0.14||0.0709|TWO_SIDED|95.0|0.45|1.03|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.03|0.45|0.0709
91543714|NCT02528188|182966043|SUPERIORITY|||||||0.6037|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6037
91543715|NCT02528188|182966043|SUPERIORITY|||||||0.1928|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1928
91543716|NCT02528188|182966043|SUPERIORITY|||||||0.7204|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7204
91543717|NCT02528188|182966043|SUPERIORITY|||||||0.7969|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7969
91543718|NCT02528188|182966043|SUPERIORITY|||||||0.7857|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7857
91543719|NCT02528188|182966043|SUPERIORITY|||||||0.6627|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6627
91543720|NCT02528188|182966043|SUPERIORITY|||||||0.9867|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.9867
91543721|NCT02528188|182966043|SUPERIORITY|||||||0.819|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.8190
91543722|NCT02528188|182966043|SUPERIORITY|||||||0.7284|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7284
91543723|NCT02528188|182966043|SUPERIORITY|||||||0.1545|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1545
91543724|NCT00475501|182966099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.9|STANDARD_DEVIATION|2.57|<|0.001|TWO_SIDED|95.0|7.86|18.0||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis||mean difference is for subjects reveiving testosterone (groups T and T/F) vs. subjects not receiving testosterone (F and Placebo)|The studies was powered for 1-RM strength based on a 1.18-alpha increase reported in the literature||18.0|7.86|<0.001
91543725|NCT00475501|182966100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_DEVIATION|0.311||0.015|TWO_SIDED|95.0|0.16|1.31||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on grip strength. We employed 2x2 analysis to determine effects of testosterone, finasteride and interaction.||1.31|0.16|0.015
91543726|NCT00475501|182966101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19|STANDARD_DEVIATION|1.142|<|0.001|TWO_SIDED|95.0|1.95|6.43||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on lumbar spine bone mineral density. We employed a 2x2 analysis for effects ot testosterone, finasteride and interaction||6.43|1.95|<0.001
91543727|NCT00475501|182966102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737|STANDARD_ERROR_OF_MEAN|0.343||0.037|TWO_SIDED|95.0|-1.41|-0.064||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study is was not powered for score on Geriatric Depression Scale||-0.064|-1.41|0.037
91543728|NCT00475501|182966103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.871|STANDARD_ERROR_OF_MEAN|1.108||0.012|TWO_SIDED|95.0|0.699|5.04||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for 30-minute recall on Rey figure test||5.04|0.699|0.012
91543729|NCT00475501|182966104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.642|STANDARD_ERROR_OF_MEAN|2.272||0.779|TWO_SIDED|95.0|-5.095|3.811||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Trials A test||3.811|-5.095|0.779
91543730|NCT00475501|182966105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.587|STANDARD_ERROR_OF_MEAN|0.743||0.433|TWO_SIDED|95.0|-0.869|2.043||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Benton test||2.043|-0.869|0.433
91543731|NCT00475501|182966106|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|0.54|<|0.001|TWO_SIDED|95.0|3.07|5.18||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||This study was powered for hematocrit based on literature report that testosterone \> 2 alpha increase in hematocrit||5.18|3.07|<0.001
91543732|NCT00475501|182966107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1419|STANDARD_ERROR_OF_MEAN|0.2529||0.6219|TWO_SIDED|95.0|-0.353|6.37||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for dietary protein intake||6.37|-0.353|0.6219
91543733|NCT00475501|182966108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.33|STANDARD_DEVIATION|1.83||0.0051|TWO_SIDED|95.0|1.73|8.94||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was powered for prostate volume based on a literature report that testosterone increases prostate volume 1.85 alpha per year. We employed a 2x2 analysis for effects of testosterone, finasteride and interaction.||8.94|1.73|0.0051
91543734|NCT00475501|182966109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.868|STANDARD_ERROR_OF_MEAN|0.668||0.196|TWO_SIDED|95.0|-3.434|1.698||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Lif Satisfaction A test||1.698|-3.434|0.196
91543735|NCT02299375|182966110|SUPERIORITY_OR_OTHER||Adjusted median|1.04|STANDARD_DEVIATION|0.28|||TWO_SIDED|95.0|0.63|1.73|||||Data presented above are for 95% equal-tailed credible intervals. The estimated posterior probability that the true ratio losmapimod/placebo is \<1 assuming noninformative priors is 0.44.The estimated posterior probability that the true ratio losmapi|||1.73|0.63|
91543736|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.371|TWO_SIDED|95.0|-0.031|0.084||Analysis performed using a Mixed-effect Model Repeated Measures (MMRM) with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 2|||0.084|-0.031|0.371
91543737|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.244|TWO_SIDED|95.0|-0.024|0.093||Analysis performed using a Mixed-effect Repeated Measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 4|||0.093|-0.024|0.244
91543738|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.05|TWO_SIDED|95.0|0.0|0.119||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 8|||0.119|-0.000|0.050
91543739|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.942|TWO_SIDED|95.0|-0.063|0.058||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 12|||0.058|-0.063|0.942
91764003|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|1.41|||||TWO_SIDED|95.0|1.18|1.69||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.69|1.18|
91764004|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|1.09|||||TWO_SIDED|95.0|0.99|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.99|
91764005|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.18|0.98|
91764006|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.81|
91764007|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.83|
91543740|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.127|TWO_SIDED|95.0|-0.014|0.114||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 18|||0.114|-0.014|0.127
91543741|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.024|TWO_SIDED|95.0|0.011|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 26|||0.148|0.011|0.024
91543742|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.057|TWO_SIDED|95.0|-0.003|0.174||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 39|||0.174|-0.003|0.057
91764008|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|0.84|||||TWO_SIDED|95.0|0.76|0.92||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.92|0.76|
91764009|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.91|
91764010|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.89|||||TWO_SIDED|95.0|0.82|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.82|
91543743|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.481|TWO_SIDED|95.0|-0.09|0.191||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 52|||0.191|-0.090|0.481
91543744|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.014||||0.521|TWO_SIDED|95.0|-0.03|0.059||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 2|||0.059|-0.030|0.521
91543745|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.084|TWO_SIDED|95.0|-0.005|0.086||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 4|||0.086|-0.005|0.084
91543746|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.266|TWO_SIDED|95.0|-0.025|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 8|||0.090|-0.025|0.266
91543747|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.665|TWO_SIDED|95.0|-0.066|0.042||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 12|||0.042|-0.066|0.665
91543748|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023||||0.489|TWO_SIDED|95.0|-0.043|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 18|||0.090|-0.043|0.489
91543749|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.099||||0.007|TWO_SIDED|95.0|0.028|0.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 26|||0.170|0.028|0.007
91764011|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||0.80|0.67|
91764012|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||1.20|0.91|
91543750|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.248|TWO_SIDED|95.0|-0.039|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 39|||0.148|-0.039|0.248
91543751|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043||||0.506|TWO_SIDED|95.0|-0.087|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 52|||0.172|-0.087|0.506
91543752|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051||||0.223|TWO_SIDED|95.0|-0.032|0.134||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 2|||0.134|-0.032|0.223
91543753|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046||||0.276|TWO_SIDED|95.0|-0.037|0.129||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 4|||0.129|-0.037|0.276
91543754|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.075||||0.131|TWO_SIDED|95.0|-0.023|0.173||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 8|||0.173|-0.023|0.131
91543755|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.003||||0.949|TWO_SIDED|95.0|-0.084|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 12|||0.090|-0.084|0.949
91543756|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.259|TWO_SIDED|95.0|-0.044|0.163||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 18|||0.163|-0.044|0.259
91543757|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 26|||0.172|-0.027|0.152
91543758|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.114||||0.076|TWO_SIDED|95.0|-0.012|0.241||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 39|||0.241|-0.012|0.076
91543759|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171||||0.107|TWO_SIDED|95.0|-0.038|0.381||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 52|||0.381|-0.038|0.107
91543760|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.484|TWO_SIDED|95.0|-0.046|0.097||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 2|||0.097|-0.046|0.484
91543761|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.256|TWO_SIDED|95.0|-0.027|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 4|||0.100|-0.027|0.256
91543762|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052||||0.184|TWO_SIDED|95.0|-0.025|0.128||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 8|||0.128|-0.025|0.184
91543763|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001||||0.97|TWO_SIDED|95.0|-0.077|0.074||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 12|||0.074|-0.077|0.970
91543764|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.608|TWO_SIDED|95.0|-0.07|0.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 18|||0.120|-0.070|0.608
91543765|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084||||0.071|TWO_SIDED|95.0|-0.007|0.175||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 26|||0.175|-0.007|0.071
91543766|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.622|TWO_SIDED|95.0|-0.085|0.141||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 39|||0.141|-0.085|0.622
91543767|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.102||||0.277|TWO_SIDED|95.0|-0.086|0.291||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 52|||0.291|-0.086|0.277
91543768|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.241|TWO_SIDED|95.0|-0.038|0.15||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 2|||0.150|-0.038|0.241
91543769|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.348|TWO_SIDED|95.0|-0.049|0.14|||MMRM||FVC Pre-dose, Week 4|||0.140|-0.049|0.348
91543770|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.138|TWO_SIDED|95.0|-0.024|0.169||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 8|||0.169|-0.024|0.138
91543771|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.813|TWO_SIDED|95.0|-0.111|0.087||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 12|||0.087|-0.111|0.813
91543772|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.172|TWO_SIDED|95.0|-0.032|0.177||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 18|||0.177|-0.032|0.172
91543773|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.242|TWO_SIDED|95.0|-0.045|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 26|||0.180|-0.045|0.242
91543774|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.082||||0.267|TWO_SIDED|95.0|-0.063|0.228||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 39|||0.228|-0.063|0.267
91543775|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.471|TWO_SIDED|95.0|-0.143|0.309||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 52|||0.309|-0.143|0.471
91543776|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.315|TWO_SIDED|95.0|-0.043|0.132||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 2|||0.132|-0.043|0.315
91543777|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054||||0.143|TWO_SIDED|95.0|-0.018|0.126||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 4|||0.126|-0.018|0.143
91543778|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072||||0.111|TWO_SIDED|95.0|-0.017|0.16||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 8|||0.160|-0.017|0.111
91543779|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.012||||0.783|TWO_SIDED|95.0|-0.075|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 12|||0.100|-0.075|0.783
91543780|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.283|TWO_SIDED|95.0|-0.049|0.167||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 18|||0.167|-0.049|0.283
91543781|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.038|TWO_SIDED|95.0|0.008|0.267||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 26|||0.267|0.008|0.038
91543782|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.467|TWO_SIDED|95.0|-0.083|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 39|||0.180|-0.083|0.467
91543783|NCT02299375|182966113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042||||0.64|TWO_SIDED|95.0|-0.138|0.222||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 52|||0.222|-0.138|0.640
91543784|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.661|TWO_SIDED|95.0|-2.08|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 2|||3.27|-2.08|0.661
91543785|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.074|TWO_SIDED|95.0|-0.24|5.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 6|||5.12|-0.24|0.074
91543786|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.21|TWO_SIDED|95.0|-1.43|6.46||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 8|||6.46|-1.43|0.210
91543787|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.933|TWO_SIDED|95.0|-3.4|3.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 12|||3.12|-3.40|0.933
91543788|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.7||||0.091|TWO_SIDED|95.0|-0.43|5.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 18|||5.82|-0.43|0.091
91543789|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.69||||0.018|TWO_SIDED|95.0|0.82|8.56||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 26|||8.56|0.82|0.018
91543790|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.103|TWO_SIDED|95.0|-0.69|7.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 39|||7.29|-0.69|0.103
91543791|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.16||||0.448|TWO_SIDED|95.0|-3.5|7.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 52|||7.82|-3.50|0.448
91764013|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.74|
91764014|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.68|0.83||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.83|0.68|
91764015|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.80|
91764016|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.83|
91764017|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.98|0.79|
91543792|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.089|TWO_SIDED|95.0|-0.27|3.77||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 2|||3.77|-0.27|0.089
91543793|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.095|TWO_SIDED|95.0|-0.31|3.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 4|||3.84|-0.31|0.095
91764018|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.97|
91764019|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 24F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.92|
91764020|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.01||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.01|0.85|
91764021|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.98|||||TWO_SIDED|95.0|0.9|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.90|
91543794|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19||||0.073|TWO_SIDED|95.0|-0.2|4.58||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 8|||4.58|-0.20|0.073
91543795|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.853|TWO_SIDED|95.0|-2.08|2.51||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 12|||2.51|-2.08|0.853
91543796|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.334|TWO_SIDED|95.0|-1.43|4.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 18|||4.17|-1.43|0.334
91543797|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.33||||0.017|TWO_SIDED|95.0|0.61|6.05||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 26|||6.05|0.61|0.017
91543798|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13||||0.077|TWO_SIDED|95.0|-0.34|6.59||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 39|||6.59|-0.34|0.077
91543799|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.34||||0.355|TWO_SIDED|95.0|-2.7|7.38||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 52|||7.38|-2.70|0.355
91543800|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.82||||0.044|TWO_SIDED|95.0|0.08|5.55||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 2|||5.55|0.08|0.044
91543801|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.87||||0.032|TWO_SIDED|95.0|0.25|5.49||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 4|||5.49|0.25|0.032
91764022|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.82|
91764023|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.74|0.52|
91543802|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.025|TWO_SIDED|95.0|0.49|7.01||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 8|||7.01|0.49|0.025
91543803|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.785|TWO_SIDED|95.0|-2.5|3.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 12|||3.29|-2.50|0.785
91543804|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34||||0.052|TWO_SIDED|95.0|-0.03|6.7||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 18|||6.70|-0.03|0.052
91543805|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53||||0.041|TWO_SIDED|95.0|0.14|6.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 26|||6.92|0.14|0.041
91543806|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19||||0.043|TWO_SIDED|95.0|0.13|8.25||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 39|||8.25|0.13|0.043
91543807|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.67||||0.562|TWO_SIDED|95.0|-6.58|11.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 52|||11.92|-6.58|0.562
91543808|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.746|TWO_SIDED|95.0|-1.09|1.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 2|||1.52|-1.09|0.746
91543809|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.878|TWO_SIDED|95.0|-1.53|1.79||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 4|||1.79|-1.53|0.878
91543810|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35||||0.644|TWO_SIDED|95.0|-1.15|1.85||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 8|||1.85|-1.15|0.644
91543811|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.715|TWO_SIDED|95.0|-1.86|1.28||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 12|||1.28|-1.86|0.715
91543812|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.803|TWO_SIDED|95.0|-1.62|2.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 18|||2.10|-1.62|0.803
91543813|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.184|TWO_SIDED|95.0|-0.63|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 26|||3.27|-0.63|0.184
91543814|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05||||0.102|TWO_SIDED|95.0|-0.42|4.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 39|||4.52|-0.42|0.102
91543815|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44||||0.383|TWO_SIDED|95.0|-1.85|4.73||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 52|||4.73|-1.85|0.383
91543816|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.607|TWO_SIDED|95.0|-1.2|2.06||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 2|||2.06|-1.20|0.607
91543817|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.348|TWO_SIDED|95.0|-0.74|2.08||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 4|||2.08|-0.74|0.348
91543818|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.826|TWO_SIDED|95.0|-1.32|1.65||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 8|||1.65|-1.32|0.826
91543819|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.588|TWO_SIDED|95.0|-2.13|1.21||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 12|||1.21|-2.13|0.588
91543820|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.585|TWO_SIDED|95.0|-1.08|1.91||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 18|||1.91|-1.08|0.585
91543821|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.82||||0.231|TWO_SIDED|95.0|-2.48|10.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 26|||10.12|-2.48|0.231
91543822|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.45||||0.24|TWO_SIDED|95.0|-0.99|3.89||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 39|||3.89|-0.99|0.240
91543823|NCT02299375|182966114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.517|TWO_SIDED|95.0|-2.49|4.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 52|||4.84|-2.49|0.517
91543824|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.706|TWO_SIDED|95.0|-4.2|2.85||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 12|||2.85|-4.20|0.706
91543825|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.694|TWO_SIDED|95.0|-3.58|5.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 26|||5.36|-3.58|0.694
91764024|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.76|0.62|
91543826|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.83||||0.382|TWO_SIDED|95.0|-9.23|3.58||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 39|||3.58|-9.23|0.382
91764025|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.90|0.74|
91764026|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.17|0.89|
91543827|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.903|TWO_SIDED|95.0|-8.54|7.57||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 52|||7.57|-8.54|0.903
91543828|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.481|TWO_SIDED|95.0|-6.33|2.99||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 12|||2.99|-6.33|0.481
91543829|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.793|TWO_SIDED|95.0|-4.79|6.25||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 26|||6.25|-4.79|0.793
91543830|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6||||0.421|TWO_SIDED|95.0|-12.45|5.26||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 39|||5.26|-12.45|0.421
91543831|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.98||||0.162|TWO_SIDED|95.0|-19.35|3.4||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 52|||3.40|-19.35|0.162
91764027|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.06|0.85|
91764028|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.16|1.44||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.44|1.16|
91543832|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.592|TWO_SIDED|95.0|-3.31|5.78||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 12|||5.78|-3.31|0.592
91543833|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.704|TWO_SIDED|95.0|-4.31|6.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 26|||6.36|-4.31|0.704
91543834|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.546|TWO_SIDED|95.0|-10.32|5.5||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 39|||5.50|-10.32|0.546
91543835|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.35|TWO_SIDED|95.0|-5.06|13.84||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 52|||13.84|-5.06|0.350
91543836|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.411|TWO_SIDED|95.0|-5.75|2.37||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 12|||2.37|-5.75|0.411
91764029|NCT03197376|183418431|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.13|0.89|
91764030|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10%, for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 1|0.7|||||TWO_SIDED|97.5|0.0|1.9||||||||1.9|-0.0|
91764031|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 5|2.8|||||TWO_SIDED|97.5|1.2|5.0||||||||5.0|1.2|
91543837|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.896|TWO_SIDED|95.0|-5.67|4.97||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 26|||4.97|-5.67|0.896
91543838|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.21||||0.559|TWO_SIDED|95.0|-9.73|5.3||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 39|||5.30|-9.73|0.559
91543839|NCT02299375|182966121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.809|TWO_SIDED|95.0|-12.19|9.6||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 52|||9.60|-12.19|0.809
91543840|NCT00704184|182966156|SUPERIORITY_OR_OTHER||Adjusted difference in %|69.3|||<|0.001|TWO_SIDED|95.0|40.3|86.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||86.7|40.3|<0.001
91543841|NCT00704184|182966156|SUPERIORITY_OR_OTHER||Adjusted difference in %|73.6|||<|0.001|TWO_SIDED|95.0|46.0|88.6|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||88.6|46.0|<0.001
91543842|NCT00704184|182966156|SUPERIORITY_OR_OTHER||Adjusted difference in %|63.3|||<|0.001|TWO_SIDED|95.0|32.8|82.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||82.7|32.8|<0.001
91764032|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6A|5.2|||||TWO_SIDED|97.5|1.1|9.5||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||9.5|1.1|
91764033|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6B|2.0|||||TWO_SIDED|97.5|-2.2|6.4||||||||6.4|-2.2|
91764034|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 7F|1.0|||||TWO_SIDED|97.5|-0.1|2.7||||||||2.7|-0.1|
91764035|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 9V|0.1|||||TWO_SIDED|97.5|-1.9|2.5||||||||2.5|-1.9|
91764036|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 14|-0.3|||||TWO_SIDED|97.5|-1.4|1.0||||||||1.0|-1.4|
91543843|NCT00704184|182966156|SUPERIORITY_OR_OTHER||Adjusted difference in %|77.8|||<|0.001|TWO_SIDED|95.0|49.2|91.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).|||91.3|49.2|<0.001
91543844|NCT00704184|182966159|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
91543845|NCT00704184|182966159|SUPERIORITY_OR_OTHER||Adjusted difference|10.8|||||TWO_SIDED|95.0|-7.6|33.2|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.2|-7.6|
91543846|NCT00704184|182966159|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
91543847|NCT00704184|182966159|SUPERIORITY_OR_OTHER||Adjusted difference|5.4|||||TWO_SIDED|95.0|-16.5|28.4|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||28.4|-16.5|
91543848|NCT00704184|182966160|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
91543849|NCT00704184|182966160|SUPERIORITY_OR_OTHER||Adjusted difference|16.2|||||TWO_SIDED|95.0|-2.2|39.5|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||39.5|-2.2|
91543850|NCT00704184|182966160|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
91543851|NCT00704184|182966160|SUPERIORITY_OR_OTHER||Adjusted difference|10.7|||||TWO_SIDED|95.0|-11.4|34.6|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||34.6|-11.4|
91764037|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19A|18.7|||||TWO_SIDED|97.5|15.1|22.5||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||22.5|15.1|
91543852|NCT00704184|182966161|SUPERIORITY_OR_OTHER||Difference in Least Squares (LC) Means|-2.5|||||TWO_SIDED|95.0|-3.2|-1.8|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-1.8|-3.2|
91543853|NCT00704184|182966161|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
91543854|NCT00704184|182966161|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
91543855|NCT00704184|182966161|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.3|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.3|
91543856|NCT00716859|182966166|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.|Mean Difference (Net)|1.46|||||TWO_SIDED|95.0|-0.81|3.74||||||Null hypothesis: latanoprost inferior to timolol (0.5 percent \[%\] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.||3.74|-0.81|
91543857|NCT00716859|182966167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|-1.66|3.02||||||||3.02|-1.66|
91543858|NCT00716859|182966168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|-1.0|4.25||||||||4.25|-1.00|
91543859|NCT00716859|182966169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4085|||||TWO_SIDED|95.0|-1.1|2.67||||||||2.67|-1.10|
91543860|NCT00716859|182966174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3315|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).||||||0.3315
91543861|NCT02178098|182966176|SUPERIORITY||Least squares mean difference|-24.24|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-30.33|-18.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-18.15|-30.33|<0.0001
91543862|NCT02178098|182966177|SUPERIORITY||Least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.511||0.2808|TWO_SIDED|95.0|-4.62|1.35|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.35|-4.62|0.2808
91543863|NCT02178098|182966178|SUPERIORITY||Least squares mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.111||0.3461|TWO_SIDED|95.0|-3.25|1.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.15|-3.25|0.3461
91543864|NCT02178098|182966179|SUPERIORITY||Least squares mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.734||0.1852|TWO_SIDED|95.0|-5.74|1.12|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.12|-5.74|0.1852
91543865|NCT02178098|182966180|SUPERIORITY||Least squares mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.253||0.2481|TWO_SIDED|95.0|-3.93|1.03|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.03|-3.93|0.2481
91543866|NCT02178098|182966181|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.684||0.8181|TWO_SIDED|95.0|-3.72|2.94|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.94|-3.72|0.8181
91543867|NCT02178098|182966182|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.274||0.8817|TWO_SIDED|95.0|-2.33|2.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.71|-2.33|0.8817
91764038|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19F|-0.8|||||TWO_SIDED|97.5|-1.9|0.5||||||||0.5|-1.9|
91764039|NCT03197376|183418432|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 23F|17.2|||||TWO_SIDED|97.5|13.6|21.1||||||||21.1|13.6|
91543868|NCT02178098|182966183|SUPERIORITY||Least squares mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.829||0.404|TWO_SIDED|95.0|-2.09|5.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||5.15|-2.09|0.4040
91764040|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 1 GMC Ratio|2.15|||||TWO_SIDED|97.5|2.0|2.32||||||||2.32|2.00|
91764041|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 5 GMC Ratio|1.37|||||TWO_SIDED|97.5|1.28|1.47||||||||1.47|1.28|
91764042|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6A GMC Ratio|0.89|||||TWO_SIDED|97.5|0.78|1.01||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.01|0.78|
91764043|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6B GMC Ratio|1.07|||||TWO_SIDED|97.5|0.93|1.24||||||||1.24|0.93|
91543869|NCT02178098|182966184|SUPERIORITY||Least squares mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.178||0.5061|TWO_SIDED|95.0|-1.54|3.11|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||3.11|-1.54|0.5061
91543870|NCT02178098|182966185|SUPERIORITY||Median Difference (Final Values)|-43.64|||<|0.0001|TWO_SIDED|95.0|-62.8|-25.21|||Wilcoxon Rank-Sum Test||The 95% confidence interval (CI) was calculated using Hodges-Lehmann analysis.|||-25.21|-62.80|<0.0001
91543871|NCT02178098|182966186|SUPERIORITY||Least squares mean difference|-16.67|STANDARD_ERROR_OF_MEAN|2.006|<|0.0001|TWO_SIDED|95.0|-20.63|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-12.70|-20.63|<0.0001
91543872|NCT02178098|182966187|SUPERIORITY||Least squares mean difference|-18.9|STANDARD_ERROR_OF_MEAN|2.624|<|0.0001|TWO_SIDED|95.0|-24.09|-13.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.71|-24.09|<0.0001
91764044|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 7F GMC Ratio|1.3|||||TWO_SIDED|97.5|1.19|1.41||||||||1.41|1.19|
91764045|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 9V GMC Ratio|0.92|||||TWO_SIDED|97.5|0.85|1.0||||||||1.00|0.85|
91764046|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 14 GMC Ratio|1.23|||||TWO_SIDED|97.5|1.1|1.37||||||||1.37|1.10|
91764047|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19A GMC Ratio|1.45|||||TWO_SIDED|97.5|1.3|1.63||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.63|1.30|
91764048|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19F GMC Ratio|0.73|||||TWO_SIDED|97.5|0.67|0.8||||||||0.80|0.67|
91764049|NCT03197376|183418433|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 23F GMC Ratio|1.81|||||TWO_SIDED|97.5|1.63|2.01||||||||2.01|1.63|
91764050|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for diphtheria|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
91764051|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Tetanus|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
91764052|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hepatitis B|0.4|||||TWO_SIDED|95.0|-0.4|2.5||||||||2.5|-0.4|
91764053|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hib|-0.9|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
91764054|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 1|-0.2|||||TWO_SIDED|95.0|-1.3|1.5||||||||1.5|-1.3|
91764055|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 2|2.8|||||TWO_SIDED|95.0|-3.2|9.3||||||||9.3|-3.2|
91764056|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 3|-0.9|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
91543873|NCT02178098|182966188|SUPERIORITY||Least squares mean difference|-18.69|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED|95.0|-23.62|-13.77|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.77|-23.62|<0.0001
91543874|NCT02178098|182966189|SUPERIORITY||Median Difference (Final Values)|5.25||||0.3689|TWO_SIDED|95.0|-6.78|16.42|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||16.42|-6.78|0.3689
91764057|NCT03197376|183418434|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Rotavirus|0.2|||||TWO_SIDED|95.0|-7.1|7.1||||||||7.1|-7.1|
91764058|NCT03197376|183418435|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-pertussis toxoid|0.82|||||TWO_SIDED|95.0|0.62|1.09||||||||1.09|0.62|
91764059|NCT03197376|183418436|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-fimbriae 2/3|0.98|||||TWO_SIDED|95.0|0.77|1.25||||||||1.25|0.77|
91543875|NCT02178098|182966190|SUPERIORITY||Least squares mean difference|-8.18|STANDARD_ERROR_OF_MEAN|2.319||0.0006|TWO_SIDED|95.0|-12.76|-3.59|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-3.59|-12.76|0.0006
91543876|NCT02178098|182966191|SUPERIORITY||Median Difference (Final Values)|7.6||||0.3093|TWO_SIDED|95.0|-8.21|24.02|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||24.02|-8.21|0.3093
91543877|NCT02515305|182966256|EQUIVALENCE|provides 85% power of success|equivalence ratio|97.54|||||TWO_SIDED|90.0|94.6|104.7||No p-value calculated, just a T/R ratio and 90% confidence interval for the bioequivalence analysis|Fieller's method|||||104.7|94.6|
91543878|NCT02515305|182966257|EQUIVALENCE|provides 85% power of success|Equivalence ratio|100.1|||||TWO_SIDED|90.0|96.0|109.3|||Fieller's method|||||109.3|96|
91543879|NCT03087708|182966267|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
91543880|NCT03087708|182966267|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
91543881|NCT03087708|182966267|OTHER||||||<|0.6546|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<0.6546
91764060|NCT03197376|183418443|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 6A|73.3|||||TWO_SIDED|97.5|69.8|76.3||||||||76.3|69.8|
91764061|NCT03197376|183418443|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 19A|54.7|||||TWO_SIDED|97.5|50.3|58.9||||||||58.9|50.3|
91764062|NCT03197376|183418444|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 6A GMC Ratio|8.51|||||TWO_SIDED|97.5|7.68|9.43||||||||9.43|7.68|
91764063|NCT03197376|183418444|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 19A GMC Ratio|5.64|||||TWO_SIDED|97.5|5.14|6.18||||||||6.18|5.14|
91764064|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 1|17.2|||||TWO_SIDED|95.0|11.0|23.6||||||||23.6|11.0|
91764065|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 5|2.8|||||TWO_SIDED|95.0|0.0|6.2||||||||6.2|-0.0|
91764066|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6A|82.2|||||TWO_SIDED|95.0|76.7|86.6||||||||86.6|76.7|
91764067|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6B|9.4|||||TWO_SIDED|95.0|4.5|14.6||||||||14.6|4.5|
91764068|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 7F|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||||2.2|-1.1|
91764069|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
91764070|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type14|-0.8|||||TWO_SIDED|95.0|-4.0|2.2||||||||2.2|-4.0|
91543882|NCT03087708|182966267|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
91543883|NCT03087708|182966267|OTHER||||||<|0.2262|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.2262
91543884|NCT03087708|182966267|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
91764071|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19A|53.3|||||TWO_SIDED|95.0|46.0|60.1||||||||60.1|46.0|
91764072|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19F|-1.6|||||TWO_SIDED|95.0|-4.9|1.2||||||||1.2|-4.9|
91764073|NCT03197376|183418445|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
91764074|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 1|3.09|||||TWO_SIDED|95.0|2.4|3.98||||||||3.98|2.40|
91543885|NCT03087708|182966267|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<1
91543886|NCT03087708|182966271|OTHER||||||<|0.68182|||||||Fisher Exact|||||||<0.68182
91543887|NCT03087708|182966271|OTHER||||||<|0.1091|||||||Fisher Exact|||||||<0.1091
91543888|NCT03087708|182966272|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.0
91543889|NCT03087708|182966272|OTHER||||||<|0.3339|||||||Wilcoxon (Mann-Whitney)|||||||<0.3339
91543890|NCT03087708|182966273|OTHER||||||<|0.593|||||||Wilcoxon (Mann-Whitney)|||||||<0.5930
91543891|NCT03087708|182966273|OTHER||||||<|0.3105|||||||Wilcoxon (Mann-Whitney)|||||||<0.3105
91543892|NCT03087708|182966274|OTHER|||||||0.6024|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||0.6024
91543893|NCT03087708|182966274|OTHER||||||<|0.3116|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||<0.3116
91543894|NCT03087708|182966274|OTHER||||||<|0.7712|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<0.7712
91543895|NCT03087708|182966274|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<1.0
91543896|NCT03087708|182966275|OTHER||||||<|1|||||||Fisher Exact|||Analgesic Use at 6 Months||||<1.0000
91543897|NCT03087708|182966275|OTHER||||||<|0.5758|||||||Fisher Exact|||Analgesic Use at 6 Months||||<0.5758
91543898|NCT03087708|182966275|OTHER||||||<|1|||||||Fisher Exact|||Analgesic use at Baseline||||<1.0000
91543899|NCT03087708|182966275|OTHER|||||||0.593|||||||Fisher Exact|||Analgesic use at Baseline||||0.5930
91543900|NCT01827787|182966280|SUPERIORITY|||||||0.42|||||||Fisher Exact|||"Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.~Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done."||||0.42
91543901|NCT02769858|182966289|OTHER|||||||0.001|||||||t-test, 2 sided|||||||.001
91543902|NCT02769858|182966290|OTHER|||||||0.019|||||||t-test, 2 sided|||||||.019
91543903|NCT02769858|182966291|OTHER|||||||0.502|||||||t-test, 2 sided|||||||.502
91543904|NCT01853748|182966308|SUPERIORITY|||||||0.0012|||||||Mantel Haenszel|||||||0.0012
91543905|NCT01853748|182966313|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
91543906|NCT01853748|182966316|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
91764075|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 5|1.39|||||TWO_SIDED|95.0|1.12|1.72||||||||1.72|1.12|
91764076|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6A|186.0|||||TWO_SIDED|95.0|144.0|241.0||||||||241|144|
91764077|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6B|1.95|||||TWO_SIDED|95.0|1.42|2.69||||||||2.69|1.42|
91764078|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 7F|1.16|||||TWO_SIDED|95.0|0.96|1.39||||||||1.39|0.96|
91764079|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 9V|0.38|||||TWO_SIDED|95.0|0.29|0.49||||||||0.49|0.29|
91764080|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 14|0.92|||||TWO_SIDED|95.0|0.67|1.27||||||||1.27|0.67|
91764081|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19A|13.4|||||TWO_SIDED|95.0|10.2|17.7||||||||17.7|10.2|
91764082|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19F|0.66|||||TWO_SIDED|95.0|0.54|0.81||||||||0.81|0.54|
91764083|NCT03197376|183418446|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 23F|3.03|||||TWO_SIDED|95.0|2.25|4.09||||||||4.09|2.25|
91764084|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.31|1.52||||||||1.52|1.31|
91543907|NCT03088813|182966421|OTHER||Hazard Ratio (HR)|1.11||||0.3094|TWO_SIDED|95.0|0.9|1.37|||Stratified log-rank test|From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity.|The associated HR and two-sided 95% Confidence Interval (CI) were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.37|0.90|0.3094
91543908|NCT03088813|182966425|OTHER||Hazard Ratio (HR)|0.96||||0.7053|TWO_SIDED|95.0|0.77|1.2||From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity|Stratified log-rank test||The associated HR and two-sided 95% CI were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.20|0.77|0.7053
91543909|NCT03088813|182966426|OTHER||Difference in ORR|22.29|||<|0.0001|TWO_SIDED|95.0|13.97|30.61||ORR difference, 95% CI and P-value are obtained from the Cochran-Mantel-Haenszel test stratified by corrected region and corrected platinum sensitivity.|Cochran-Mantel-Haenszel|||||30.61|13.97|<0.0001
91543910|NCT04878354|182966431|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.0004|TWO_SIDED|95.0|0.58|2.0|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||2.00|0.58|0.0004
91543911|NCT04878354|182966432|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.001|TWO_SIDED|95.0|0.34|1.35|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||1.35|0.34|0.0010
91543912|NCT04878354|182966433|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.0354|TWO_SIDED|95.0|0.03|0.71|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.71|0.03|0.0354
91543913|NCT04878354|182966434|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.0734|TWO_SIDED|95.0|-0.02|0.5|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.50|-0.02|0.0734
91543914|NCT04878354|182966435|SUPERIORITY||Mean Difference (Final Values)|0.86|||<|0.0001|TWO_SIDED|95.0|0.45|1.28|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.28|0.45|<0.0001
91543915|NCT04878354|182966436|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.0002|TWO_SIDED|95.0|0.26|0.82|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.82|0.26|0.0002
91543916|NCT04878354|182966437|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.1516|TWO_SIDED|95.0|-0.11|0.76|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.76|-0.11|0.1516
91543917|NCT04878354|182966438|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9709|TWO_SIDED|95.0|-0.24|0.25|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.25|-0.24|0.9709
91543918|NCT04878354|182966439|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.0499|TWO_SIDED|95.0|0.0|0.41|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.41|0.00|0.0499
91543919|NCT04878354|182966440|SUPERIORITY||Median Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.73|2.18|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||2.18|0.73|<0.0001
91543920|NCT04878354|182966441|SUPERIORITY||Median Difference (Final Values)|0.48||||0.0075|TWO_SIDED|95.0|0.13|0.83|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.83|0.13|0.0075
91543921|NCT04878354|182966442|SUPERIORITY||Median Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.44|1.29|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.29|0.44|<0.0001
91543922|NCT04878354|182966443|SUPERIORITY||Odds Ratio (OR)|1.2|||<|0.0001|TWO_SIDED|95.0|1.1|1.32|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.32|1.10|<0.0001
91764085|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.88|||||TWO_SIDED|95.0|0.81|0.95||||||||0.95|0.81|
91764086|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|4.46|||||TWO_SIDED|95.0|4.01|4.96||||||||4.96|4.01|
91764087|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|6.43|||||TWO_SIDED|95.0|5.7|7.26||||||||7.26|5.70|
91543923|NCT04878354|182966444|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9124|TWO_SIDED|95.0|0.93|1.08|||Generalised linear mixed model (GLMM)||Odds ration is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.08|0.93|0.9124
91543924|NCT04878354|182966445|SUPERIORITY||Odds Ratio (OR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.71|0.81|||Generalised linear fixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.81|0.71|<0.0001
91764088|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|2.04|||||TWO_SIDED|95.0|1.89|2.19||||||||2.19|1.89|
91764089|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.39|||||TWO_SIDED|95.0|1.29|1.5||||||||1.50|1.29|
91764090|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.35|||||TWO_SIDED|95.0|1.21|1.51||||||||1.51|1.21|
91764091|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|2.64|||||TWO_SIDED|95.0|2.4|2.91||||||||2.91|2.40|
91764092|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.49|||||TWO_SIDED|95.0|1.36|1.63||||||||1.63|1.36|
91764093|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.5|||||TWO_SIDED|95.0|2.29|2.72||||||||2.72|2.29|
91764094|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.17|||||TWO_SIDED|95.0|1.06|1.28||||||||1.28|1.06|
91764095|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.67|||||TWO_SIDED|95.0|0.61|0.74||||||||0.74|0.61|
91543925|NCT04878354|182966446|SUPERIORITY||Odds Ratio (OR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.93|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.93|0.85|<0.0001
91543926|NCT04878354|182966447|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.72|0.84|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.84|0.72|<0.0001
91543927|NCT04878354|182966448|SUPERIORITY||Odds Ratio (OR)|0.9||||0.0001|TWO_SIDED|95.0|0.86|0.95|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.95|0.86|0.0001
91543928|NCT04878354|182966451|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0015|TWO_SIDED|95.0|0.07|0.29|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.29|0.07|0.0015
91543929|NCT04878354|182966452|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0032|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.20|0.04|0.0032
91543930|NCT04878354|182966453|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9277|TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effects (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.23|-0.21|0.9277
91543931|NCT04878354|182966454|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9643|TWO_SIDED|95.0|-0.19|0.18|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.18|-0.19|0.9643
91543932|NCT04878354|182966455|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0287|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.34|0.02|0.0287
91543933|NCT04878354|182966457|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.58|||Generalized linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet/ odds tree SLIT-tablet)|"Multiple imputation was used to impute missing data under the hypothetical strategy.~The odds of having an improved treatment efficacy according to patient-rated global evaluation was analysed using a generalised linear mixed model with a logit link function. The model includes patient-rated global evaluation of treatment efficacy (improvement/no improvement) as the response variable and treatment, cohort and age group as fixed effects and pollen station as random effects. Observed p-value."||0.58|0.30|<0.0001
91543934|NCT04878354|182966458|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|TWO_SIDED|95.0|0.38|0.48|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.48|0.38|<0.0001
91543935|NCT04878354|182966458|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.1038|TWO_SIDED|95.0|-0.09|0.01|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.01|-0.09|0.1038
91543936|NCT04878354|182966459|SUPERIORITY||Mean Difference (Final Values)|0.53|||<|0.0001|TWO_SIDED|95.0|0.48|0.57|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.57|0.48|<0.0001
91543937|NCT04878354|182966459|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.0001|TWO_SIDED|95.0|0.45|0.53|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.53|0.45|<0.0001
91764096|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|3.49|||||TWO_SIDED|95.0|2.97|4.11||||||||4.11|2.97|
91543938|NCT04878354|182966460|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.24|0.33|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.33|0.24|<0.0001
91543939|NCT04878354|182966460|SUPERIORITY||Mean Difference (Final Values)|0.31|||<|0.0001|TWO_SIDED|95.0|0.26|0.36|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.36|0.26|<0.0001
91543940|NCT02217904|182966464|SUPERIORITY||Posterior mean difference|-1.64|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
91543941|NCT02217904|182966464|SUPERIORITY||Posterior mean difference|-1.32|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
91543942|NCT02217904|182966464|SUPERIORITY||Posterior mean difference|-1.57|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
91543943|NCT02217904|182966464|SUPERIORITY||Posterior mean difference|-1.28|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
91543944|NCT02217904|182966464|SUPERIORITY||Posterior mean difference|-1.18|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
91543945|NCT01903811|182966475|SUPERIORITY||Hazard Ratio (HR)|1.061||||0.384|TWO_SIDED|80.0|0.821|1.37||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.370|0.821|0.384
91543946|NCT01903811|182966476|SUPERIORITY||Hazard Ratio (HR)|1.149||||0.284|TWO_SIDED|80.0|0.841|1.571||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.571|0.841|0.284
91543947|NCT01903811|182966477|SUPERIORITY|||||||0.113|||||||Cochran-Mantel-Haenszel|||Compare the rate of confirmed PR or better between treatment arms.||||0.1130
91543948|NCT05773313|182966531|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Food Insecurity||||>0.999
91543949|NCT05773313|182966531|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Financial Insecurity||||0.250
91543950|NCT05773313|182966531|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Social Isolation||||>0.999
91543951|NCT05773313|182966531|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Physical Inactivity||||>0.999
91543952|NCT05773313|182966531|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Disability||||>0.999
91543953|NCT05773313|182966532|SUPERIORITY|||||||0.461|||||||Wilcoxon (Mann-Whitney)|||||||0.461
91543954|NCT05773313|182966533|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
91543955|NCT05773313|182966534|SUPERIORITY|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
91543956|NCT05773313|182966535|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
91543957|NCT01534494|182966536|OTHER|Paired t-test||||||0.008|||||||t-test, 2 sided|Paired t-test for significance of change. t(8) = 3.477. P(2-sided) = 0.008||Single-group pre-post contrast||||0.008
91543958|NCT00802464|182966557|OTHER||Fold increase|5.21|||||TWO_SIDED|95.0|3.89|6.98||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||6.98|3.89|
91543959|NCT00802464|182966557|OTHER||Fold increase|4.02|||||TWO_SIDED|95.0|3.0|5.4||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||5.4|3|
91764097|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|3.85|||||TWO_SIDED|95.0|3.23|4.59||||||||4.59|3.23|
91543960|NCT00802464|182966557|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.07|1.58||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.58|1.07|
91543961|NCT00802464|182966558|OTHER||Fold increase|2.12|||||TWO_SIDED|95.0|1.67|2.69||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||2.69|1.67|
91543962|NCT00802464|182966558|OTHER||Fold increase|1.63|||||TWO_SIDED|95.0|1.28|2.07||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||2.07|1.28|
91543963|NCT00802464|182966558|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.56|1.09|
91543964|NCT00802464|182966559|OTHER||Fold increase|4.72|||||TWO_SIDED|95.0|3.81|5.85||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||5.85|3.81|
91543965|NCT00802464|182966559|OTHER||Fold increase|3.36|||||TWO_SIDED|95.0|2.72|4.17||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||4.17|2.72|
91543966|NCT00802464|182966559|OTHER||Fold increase|1.4|||||TWO_SIDED|95.0|1.17|1.68||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.68|1.17|
91543967|NCT00802464|182966560|OTHER||Fold increase|3.21|||||TWO_SIDED|36.0|2.64|3.9||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||3.9|2.64|
91543968|NCT00802464|182966560|OTHER||Fold increase|2.44|||||TWO_SIDED|95.0|2.02|2.97||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||2.97|2.02|
91543969|NCT00802464|182966560|OTHER||Fold increase|1.31|||||TWO_SIDED|95.0|1.12|1.54||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.54|1.12|
91543970|NCT00402246|182966577|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|17.4|||<|0.001||95.0||||The a priori threshold for significance was an alpha level of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||||<0.001
91543971|NCT00402246|182966578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.524|ONE_SIDED|95.0||1.21||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.21||0.524
91764098|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|1.63|||||TWO_SIDED|95.0|1.47|1.82||||||||1.82|1.47|
91764099|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.46|||||TWO_SIDED|95.0|1.31|1.62||||||||1.62|1.31|
91543972|NCT00402246|182966578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.325|ONE_SIDED|95.0||1.43||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple ED visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.43||0.325
91543973|NCT00402246|182966578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.099|ONE_SIDED|95.0||1.31||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.31||0.099
91543974|NCT00402246|182966579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.29|ONE_SIDED|95.0||2.56||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.||2.56||0.29
91543975|NCT00402246|182966582|SUPERIORITY_OR_OTHER||probability|0.23||||||95.0|||||Regression, Logistic|A GEE model was utilized to account for multiple events within same patient in estimating the probability of an AT/AF alert event being symptomatic.||||||
91543976|NCT00402246|182966584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.3||0.779|TWO_SIDED|95.0|-0.8|1.0||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||1.0|-0.8|0.779
91543977|NCT00402246|182966585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_DEVIATION|19.1|<|0.001|TWO_SIDED|95.0|-13.1|-6.9||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||-6.9|-13.1|<0.001
91543978|NCT00402246|182966586|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.002|TWO_SIDED|95.0|0.7|0.9||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.|negative binomial model|||The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.||0.9|0.7|0.002
91543979|NCT00402246|182966587|SUPERIORITY_OR_OTHER||compliance rate|0.761|||||ONE_SIDED|95.0|0.737||||Binomial Exact Test|||3-month compliance rate|||0.737|
91543980|NCT00402246|182966587|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.793||||Binomial Exact Test|||6-month compliance rate|||0.793|
91543981|NCT00402246|182966587|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.792||||Binomial Exact Test|||9-month compliance rate|||0.792|
91543982|NCT00402246|182966587|SUPERIORITY_OR_OTHER||compliance rate|0.814|||||ONE_SIDED|95.0|0.79||||Binomial Exact Test|||12-month compliance rate|||0.79|
91543983|NCT00402246|182966589|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.217
91543984|NCT00402246|182966590|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||The a priori threshold for statistical significance for was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.154
91543985|NCT02622568|182966624|NON_INFERIORITY|Veregen alone has efficacy compared to Veregen + cryotherapy|Mean Difference (Final Values)|1.556||||0.383|TWO_SIDED|||||Comparison at week 12|t-test, 2 sided|||||||0.383
91543986|NCT02622568|182966624|NON_INFERIORITY|Comparison at week 0|Mean Difference (Final Values)|-0.222||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
91764100|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.21|||||TWO_SIDED|95.0|1.03|1.42||||||||1.42|1.03|
91543987|NCT00324350|182966636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.678|TWO_SIDED|95.0|0.86|1.27||Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.|Regression, Cox|||The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.||1.27|0.86|0.678
91543988|NCT00324350|182966637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.49|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset||1.43|0.84|0.490
91764101|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|3.6|||||TWO_SIDED|95.0|2.99|4.33||||||||4.33|2.99|
91764102|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.55|||||TWO_SIDED|95.0|1.38|1.75||||||||1.75|1.38|
91543989|NCT00324350|182966638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.854|TWO_SIDED|95.0|0.88|1.11|||Mixed Models Analysis||The rate of height loss did not differ between groups (p = 0.573). Height loss of \>2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).|Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing \>2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403-410)||1.11|0.88|0.854
91543990|NCT02015520|182966641|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||||||0.38
91543991|NCT02015520|182966641|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91543992|NCT02015520|182966641|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91543993|NCT01854385|182966653|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||.079
91543994|NCT02932579|182966657|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.098|TWO_SIDED||||||t-test, 2 sided|||||||0.098
91543995|NCT02932579|182966658|SUPERIORITY||Risk Ratio (RR)|1.38||||0.74|TWO_SIDED|95.0|0.45|4.21|||Fisher Exact|||||4.21|0.45|0.740
91543996|NCT04059042|182966659|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|39.0||||0.0051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0051
91543997|NCT04059042|182966659|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|19.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
91543998|NCT04059042|182966660|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|18.0||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
91543999|NCT04059042|182966660|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|14.0||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
91544000|NCT01985334|182966749|SUPERIORITY_OR_OTHER|||||||0.018|||||||linear mixed model|||||||0.0180
91544001|NCT01985334|182966750|NON_INFERIORITY_OR_EQUIVALENCE|"H0: Glycopyrronium (50 μg o.d.) \[randomized group B2\] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~H0: μFEV1, NVA237 - μFEV1, LABA and/or LAMA \< -40 mL Ha: Glycopyrronium (50 μg o.d.) \[randomized group B2\] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~Ha: μFEV1, NVA237 - μFEV1, LABA and/or LAMA ≥ -40 mL"|||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544002|NCT01985334|182966751|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544003|NCT01985334|182966752|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544004|NCT01985334|182966753|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544005|NCT01985334|182966754|NON_INFERIORITY_OR_EQUIVALENCE|A difference of 0.6 points in TDI was adopted as boundary for non-inferiority|||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544006|NCT01985334|182966755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544007|NCT01985334|182966756|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
91544008|NCT00093015|182966765|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.41||95.0|0.94|1.17||Nominal p-value from a 2-sided log rank test is presented. The primary cardiovascular composite endpoint was tested at the 0.04056 significance level at final analysis after accounting for 4 planned interim analyses (overall alpha = 0.048).|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.17|0.94|0.41
91544009|NCT00093015|182966766|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.29||95.0|0.95|1.19||Nominal p-value from a 2-sided log rank test is presented. The primary renal composite endpoint was tested at the 0.002 significance level at final analysis.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.19|0.95|0.29
91544010|NCT00093015|182966767|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.48||95.0|0.92|1.21||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.21|0.92|0.48
91544011|NCT00093015|182966768|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.61||95.0|0.88|1.25||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.25|0.88|0.61
91544012|NCT00093015|182966769|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.96||||0.73||95.0|0.75|1.23||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.23|0.75|0.73
91544013|NCT00093015|182966770|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.92|||<|0.001||95.0|1.38|2.68||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||2.68|1.38|<0.001
91764103|NCT03197376|183418447|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.29|||||TWO_SIDED|95.0|1.98|2.65||||||||2.65|1.98|
91764104|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 1 GMC Ratio|2.34|||||TWO_SIDED|95.0|2.02|2.71||||||||2.71|2.02|
91764105|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 5 GMC Ratio|1.57|||||TWO_SIDED|95.0|1.38|1.79||||||||1.79|1.38|
91764106|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6A GMC Ratio|11.6|||||TWO_SIDED|95.0|9.67|14.0||||||||14.0|9.67|
91764107|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6B GMC Ratio|1.89|||||TWO_SIDED|95.0|1.65|2.15||||||||2.15|1.65|
91764108|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 7F GMC Ratio|1.57|||||TWO_SIDED|95.0|1.37|1.8||||||||1.80|1.37|
91544014|NCT00093015|182966771|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.24||95.0|0.74|1.08||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.08|0.74|0.24
91764109|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 9V GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||||0.99|0.76|
91764110|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 14 GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.82||||||||1.82|1.21|
91764111|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19A GMC Ratio|4.22|||||TWO_SIDED|95.0|3.52|5.06||||||||5.06|3.52|
91764112|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19F GMC Ratio|0.63|||||TWO_SIDED|95.0|0.55|0.73||||||||0.73|0.55|
91764113|NCT03197376|183418448|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 23F GMC Ratio|1.91|||||TWO_SIDED|95.0|1.63|2.24||||||||2.24|1.63|
91764114|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|3.47|||||TWO_SIDED|95.0|2.72|4.44||||||||4.44|2.72|
91764115|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|2.54|||||TWO_SIDED|95.0|2.06|3.13||||||||3.13|2.06|
91764116|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|2.5|||||TWO_SIDED|95.0|1.83|3.42||||||||3.42|1.83|
91764117|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.76|||||TWO_SIDED|95.0|2.48|5.69||||||||5.69|2.48|
91764118|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|3.89|||||TWO_SIDED|95.0|2.92|5.18||||||||5.18|2.92|
91764119|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|6.85|||||TWO_SIDED|95.0|4.45|10.52||||||||10.52|4.45|
91764120|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|2.45|||||TWO_SIDED|95.0|1.64|3.65||||||||3.65|1.64|
91544015|NCT00093015|182966772|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.02||||0.83||95.0|0.87|1.18||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.18|0.87|0.83
91544016|NCT00093015|182966773|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.12||||0.54||95.0|-0.51|0.26||Nominal p-value is from the term treatment group\*visit in the mixed model.|Mixed Models Analysis|Adjusted for baseline eGFR and the stratification factors of proteinuria and CVD history.|Estimated difference in rate of decline in eGFR per year between darbepoetin alfa and placebo.|||0.26|-0.51|0.54
91544017|NCT00093015|182966774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|0.35|<|0.001||95.0|0.64|2.02||Nominal p-value is presented.|t-test, 2 sided||Difference (darbepoetin alfa - placebo)|||2.02|0.64|<0.001
91544018|NCT00093015|182966775|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84||||0.4||95.0|0.55|1.27||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.27|0.55|0.40
91544019|NCT03811535|182966781|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.||0.2|-1.1|
91544020|NCT03811535|182966782|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, region, GH peak group and gender by age group by region interaction terms as factors and baseline height as a covariate, all nested within week as a factor.||0.2|-1.1|
91544021|NCT05364684|182966810|OTHER|||||||0.4||||||Change in IHL over 6-months in absolute % IHL: Ibutamoren open-label 3.9 ± 6.7% versus historical placebo group 6.6 ± 6.1%, p=0.4.|t-test, 2 sided|||Subjects treated with open-label ibutamoren (n=7) were compared to historical placebo control subjects studied under identical inclusion criteria and procedures (n=10). The hypothesis is that open-label ibutamoren treatment would lead to a significant decrease in intrahepatic lipid content (IHL) as assessed by proton magnetic resonance spectroscopy (1H-MRS, absolute %IHL).||||0.4
91544022|NCT05364684|182966811|OTHER|||||||0.9||||||Change in cT1 over 6-months (ms): Ibutamoren open-label 39 ± 44 ms versus historical placebo group 44 ± 31 ms, p=0.9.|t-test, 2 sided|||Subjects treated with open-label ibutamoren (n=7) were compared to historical placebo control subjects studied under identical inclusion criteria and procedures (n=10). The hypothesis is that open-label ibutamoren treatment would lead to a significant decrease in hepatic inflammation and fibrosis as assessed by LiverMultiScan corrected T1 (cT1) score. There was no power calculation for this small pilot study.||||0.9
91544023|NCT05364684|182966812|OTHER|||||||0.6||||||Change in ALT over 6-months (U/L): Ibutamoren open-label 8 ± 18 U/L versus historical placebo group 4 ± 8 U/L, p=0.6.|t-test, 2 sided|||Subjects treated with open-label ibutamoren (n=7) were compared to historical placebo control subjects studied under identical inclusion criteria and procedures (n=10). The hypothesis is that open-label ibutamoren treatment would lead to a significant decrease in alanine aminotransferase (ALT). There was no power calculation for this small pilot study.||||0.6
91544024|NCT00603954|182966823|SUPERIORITY|||||||0.508|||||||Multivariate Cox models|||||||0.508
91544025|NCT00603954|182966823|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||At day 180||||0.02
91544026|NCT00603954|182966823|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||At Day 365||||0.002
91544027|NCT00603954|182966824|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||At day 100||||0.09
91544028|NCT00603954|182966824|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||At Day 40||||0.03
91544029|NCT00603954|182966824|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||At Day 180||||0.01
91544030|NCT00603954|182966825|SUPERIORITY|||||||0.0165|||||||Multivariate Cox models|||||||0.0165
91544031|NCT00603954|182966825|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|||||Mutivariate|||||||0.010
91544032|NCT00603954|182966825|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0495|TWO_SIDED|95.0|||||Multivariate|||||||0.0495
91544033|NCT00603954|182966825|SUPERIORITY||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|||||Multivariate|||||||0.001
91544034|NCT00603954|182966826|SUPERIORITY|||||||0.15|||||||Fisher Exact|||19 of 49 Flu-TBI patients (39%) versus 25 of 45 TLI ATG patients (56%) had a least one episode of bacterial infection the first 100 days after transplantation (P = 0.15).||||0.15
91544035|NCT00603954|182966826|SUPERIORITY|||||||0.19|||||||Fisher Exact|||For fungal infections, the figures were 3 of 45 (6%) and 7 of 45 (16%), respectively (P = 0.19)||||0.19
91544036|NCT00603954|182966826|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Among CMV-seropositive patients and/or donors, the 100-day cumulative incidence of CMV reactivation was 31% in Flu-TBI patients versus 47% in TLI-ATG patient||||0.12
91544037|NCT00603954|182966827|SUPERIORITY||Multivariate Cox models|2.3|STANDARD_DEVIATION|0.02||0.017|TWO_SIDED|95.0|1.1|4.7|||Cumulative incidence curves|||Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively||4.7|1.1|0.017
91544038|NCT00603954|182966828|SUPERIORITY||Median Difference (Final Values)|4.0|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 0||||
91544039|NCT00603954|182966828|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 3||||
91544040|NCT00603954|182966828|SUPERIORITY||Mean Difference (Final Values)|0.95|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 10||||
91544041|NCT00603954|182966829|SUPERIORITY|||||||0.5|||||||Cumulative incidence curve|||||||0.5
91544042|NCT00603954|182966830|SUPERIORITY||multivariate analyses|2.0|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|1.0|4.1|||Kaplan-Meier method|||||4.1|1|0.14
91544043|NCT00603954|182966832|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.9|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.9
91544044|NCT00603954|182966833|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.96|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.96
91544045|NCT04705480|182966834|OTHER|The study sought to assess if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage in trauma patients. No specific assessment of inferiority or superiority was done.||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||0.687
91544046|NCT04705480|182966834|OTHER|The study sought to assess if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage in trauma patients. No specific assessment of inferiority or superiority was done.||||||0.557|||||||Wilcoxon (Mann-Whitney)|||||||0.557
91544047|NCT04705480|182966834|OTHER|The study sought to assess if adding multiple doses of pregabalin or gabapentin upon admission will reduce opioid usage in trauma patients. No specific assessment of inferiority or superiority was done.||||||0.601|||||||ANCOVA|Rank transformation was applied to account this for nonparametric outcome while adjusting for significantly different psychiatric comorbidities.||||||0.601
91544048|NCT04705480|182966835|OTHER|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
91544049|NCT04705480|182966835|OTHER|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||||||0.233
91544050|NCT04705480|182966835|OTHER|||||||0.145|||||||Wilcoxon (Mann-Whitney)|||||||0.145
91544051|NCT04705480|182966836|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Chi-squared|||||||<0.05
91544052|NCT04705480|182966836|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Chi-squared|||||||<0.05
91544053|NCT04705480|182966836|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Regression, Logistic|This was applied to adjust for significantly different psychiatric comorbidities.||||||<0.05
91544054|NCT04705480|182966837|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91544055|NCT04705480|182966837|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91544056|NCT04705480|182966837|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||ANCOVA|Rank transformation was applied to account this for nonparametric outcome while adjusting for significantly different psychiatric comorbidities.||||||<0.05
91544057|NCT04705480|182966838|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91544058|NCT04705480|182966838|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91544059|NCT04705480|182966838|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||ANCOVA|Rank transformation was applied to account this for nonparametric outcome while adjusting for significantly different psychiatric comorbidities.||||||<0.05
91544060|NCT04705480|182966839|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Chi-squared|||||||<0.05
91544061|NCT04705480|182966839|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Chi-squared|||||||<0.05
91544062|NCT04705480|182966839|OTHER|No specific assessment of inferiority or superiority was done.|||||<|0.05|||||||Regression, Logistic|This was applied to adjust for significantly different psychiatric comorbidities.||||||<0.05
91544063|NCT04970654|182966840|NON_INFERIORITY|Non-inferiority was considered confirmed if the lower bound of the 95% confidence interval was higher than the margin of -2.0 cm/year.|Treatment difference|0.6|||||TWO_SIDED|95.0|-0.2|1.3||||||Hypothetical strategy estimand. Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, growth hormone (GH) peak group and gender by age group interaction term as factors and baseline height as a covariate, all nested within week as a factor.||1.3|-0.2|
91544064|NCT01996605|182966869|SUPERIORITY||||||<|0.05||||||T|ANOVA|A one-way ANOVA was performed on the single primary outcome datapoint comparing the three groups.||The null hypothesis was that there would be no difference in area of hyperalgesia 105 minutes after study drug injection among the three groups.||||<0.05
91544065|NCT03546608|182966870|OTHER||Ratio of Geometric Least Square Mean (%)|94.99|||||TWO_SIDED|90.0|64.75|139.35||||||||139.35|64.75|
91544066|NCT03546608|182966870|OTHER||Ratio of Geometric Least Square Mean (%)|87.92|||||TWO_SIDED|90.0|59.93|128.98||||||||128.98|59.93|
91544067|NCT03546608|182966871|OTHER||Ratio of Geometric Least Square Mean (%)|94.81|||||TWO_SIDED|90.0|64.09|140.26||||||||140.26|64.09|
91544068|NCT03546608|182966871|OTHER||Ratio of Geometric Least Square Mean (%)|87.2|||||TWO_SIDED|90.0|58.94|129.0||||||||129.00|58.94|
91544069|NCT03546608|182966872|OTHER||Ratio of Geometric Least Square Mean (%)|102.45|||||TWO_SIDED|90.0|80.9|129.73||||||||129.73|80.90|
91544070|NCT03546608|182966872|OTHER||Ratio of Geometric Least Square Mean (%)|71.02|||||TWO_SIDED|90.0|56.08|89.93||||||||89.93|56.08|
91544071|NCT03546608|182966883|OTHER||Ratio of Geometric Least Square Mean (%)|82.62|||||TWO_SIDED|90.0|45.67|149.47|||||For MSC2571109|||149.47|45.67|
91544072|NCT03546608|182966883|OTHER||Ratio of Geometric Least Square Mean (%)|136.59|||||TWO_SIDED|90.0|75.5|247.12|||||For MSC2571109|||247.12|75.50|
91544073|NCT03546608|182966883|OTHER||Ratio of Geometric Least Square Mean (%)|100.47|||||TWO_SIDED|90.0|54.53|185.1|||||For MSC2571107|||185.10|54.53|
91544074|NCT03546608|182966883|OTHER||Ratio of Geometric Least Square Mean (%)|94.48|||||TWO_SIDED|90.0|51.28|174.07|||||For MSC2571107|||174.07|51.28|
91544075|NCT03546608|182966884|OTHER||Ratio of Geometric Least Square Mean (%)|82.35|||||TWO_SIDED|90.0|45.56|148.84|||||For MSC2571109|||148.84|45.56|
91544076|NCT03546608|182966884|OTHER||Ratio of Geometric Least Square Mean (%)|137.51|||||TWO_SIDED|90.0|76.08|248.54|||||For MSC2571109|||248.54|76.08|
91544077|NCT03546608|182966884|OTHER||Ratio of Geometric Least Square Mean (%)|100.81|||||TWO_SIDED|90.0|55.16|184.23|||||For MSC2571107|||184.23|55.16|
91544078|NCT03546608|182966884|OTHER||Ratio of Geometric Least Square Mean (%)|96.18|||||TWO_SIDED|90.0|52.63|175.78|||||For MSC2571107|||175.78|52.63|
91544079|NCT03546608|182966885|OTHER||Ratio of Geometric Least Square Mean (%)|92.3|||||TWO_SIDED|90.0|62.52|136.26|||||For MSC2571109|||136.26|62.52|
91544080|NCT03546608|182966885|OTHER||Ratio of Geometric Least Square Mean (%)|114.8|||||TWO_SIDED|90.0|77.76|169.48|||||For MSC2571109|||169.48|77.76|
91544081|NCT03546608|182966885|OTHER||Ratio of Geometric Least Square Mean (%)|106.51|||||TWO_SIDED|90.0|70.25|161.49|||||For MSC2571107|||161.49|70.25|
91544082|NCT03546608|182966885|OTHER||Ratio of Geometric Least Square Mean (%)|72.58|||||TWO_SIDED|90.0|47.87|110.04|||||For MSC2571107|||110.04|47.87|
91544083|NCT04992390|182966893|SUPERIORITY|Poisson regression was performed with baseline measure and binary arm status included as fixed effect covariates. Various regression models for count data were compared to find the best fitting model. Visual exploratory data and model evaluation showed that the Zero Inflated Negative Binomial (ZINB) regression model provided the best fit and was used as the model for the ITT analysis of the primary outcome.|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.2|0.48||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|||For more information on analysis models see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|See also Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.48|0.20|<= 0.001
91544084|NCT04992390|182966894|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the delayed intervention arm, comparing pre-intervention (week 4) to post-intervention (week 8).|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.21|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the comparator arm, where participants had delayed access to the intervention (i.e., delayed arm crossover), the number of intrusive memories in week 8 was compared to week 4. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|For full results see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.45|0.21|<= 0.001
91544085|NCT04992390|182966894|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the immediate intervention arm, comparing pre-intervention (run-in/screening week) to post-intervention (week 4).|Incidence Rate Ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.1|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the immediate intervention arm, where participants had immediate access to the intervention, the number of intrusive memories in Week 4 was compared to the run-in/screening week. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0||0.45|0.10|<0.001
91544086|NCT04992390|182966895|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.63|||<=|0.001|TWO_SIDED|95.0|-3.72|-1.54||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How distressing were your intrusive memories?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.54|-3.72|<= 0.001
91544087|NCT04992390|182966895|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-3.21|||<=|0.001|TWO_SIDED|95.0|-4.28|-2.15||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they disrupt your concentration?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-2.15|-4.28|<= 0.001
91544088|NCT04992390|182966895|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.92|||<=|0.001|TWO_SIDED|95.0|-3.9|-1.95||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they interfere with what you were doing?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.95|-3.90|<= 0.001
91544089|NCT04992390|182966895|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.15|||<=|0.001|TWO_SIDED|95.0|-3.22|-1.08||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your work functioning?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.08|-3.22|<= 0.001
91544090|NCT04992390|182966895|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.59|||<=|0.001|TWO_SIDED|95.0|-3.67|-1.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your functioning in other areas of your life?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.51|-3.67|<= 0.001
91764121|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|3.64|||||TWO_SIDED|95.0|2.47|5.36||||||||5.36|2.47|
91764122|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|2.38|||||TWO_SIDED|95.0|1.8|3.14||||||||3.14|1.80|
91544091|NCT04992390|182966898|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.8|||<=|0.001|TWO_SIDED|95.0|-1.08|-0.53||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Total Score (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.53|-1.08|<= 0.001
91544092|NCT04992390|182966898|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.95|||<=|0.001|TWO_SIDED|95.0|-1.27|-0.62||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.62|-1.27|<= 0.001
91544093|NCT04992390|182966898|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.75|||<=|0.001|TWO_SIDED|95.0|-1.09|-0.42||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.42|-1.09|<= 0.001
91544094|NCT04992390|182966898|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.7|||<=|0.001|TWO_SIDED|95.0|-0.97|-0.44||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.44|-0.97|<= 0.001
91544095|NCT04992390|182966899|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.29|||<=|0.001|TWO_SIDED|95.0|-3.52|-1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for PTSD Checklist for DSM-5 (PCL-5) 4-item version (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.07|-3.52|<= 0.001
91544096|NCT04992390|182966900|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|5.38|||<=|0.001|TWO_SIDED|95.0|2.56|8.2||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Sleep Condition Indicator (SCI) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|8.20|2.56|<= 0.001
91544097|NCT04992390|182966901|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.93|||<=|0.05|TWO_SIDED|95.0|-1.68|-0.17||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Generalised Anxiety Disorder 2-item scale (GAD-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.17|-1.68|<=0.05
91764123|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|4.97|||||TWO_SIDED|95.0|3.49|7.06||||||||7.06|3.49|
91544098|NCT04992390|182966902|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.52|||>|0.05|TWO_SIDED|95.0|-1.23|0.19||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Patient Health Questionnaire 2-item version (PHQ-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.19|-1.23|> .05
91544099|NCT04992390|182966903|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-6.49|||<=|0.001|TWO_SIDED|95.0|-8.48|-4.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Psychological Outcome Profiles (PSYCHLOPS) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.51|-8.48|<= 0.001
91544100|NCT04992390|182966904|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-9.78|||<=|0.001|TWO_SIDED|95.0|-15.06|-4.5||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.50|-15.06|<= 0.001
91544101|NCT04992390|182966905|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|12.32|||<=|0.01|TWO_SIDED|95.0|4.61|20.04||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for 5-level European Quality of Life 5 Dimension (EQ-5D-5L) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 for EQ-5D-5L subscale comparisons and Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|20.04|4.61|<= 0.01
91764124|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|6.29|||||TWO_SIDED|95.0|4.97|7.96||||||||7.96|4.97|
91764125|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|3.19|||||TWO_SIDED|95.0|2.56|3.98||||||||3.98|2.56|
91764126|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|6.21|||||TWO_SIDED|95.0|3.55|10.84||||||||10.84|3.55|
91764127|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.25|||||TWO_SIDED|95.0|2.25|4.7||||||||4.70|2.25|
91764128|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|2.81|||||TWO_SIDED|95.0|2.13|3.69||||||||3.69|2.13|
91764129|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|2.95|||||TWO_SIDED|95.0|2.15|4.04||||||||4.04|2.15|
91764130|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|1.62|||||TWO_SIDED|95.0|1.06|2.46||||||||2.46|1.06|
91764131|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|5.98|||||TWO_SIDED|95.0|3.88|9.21||||||||9.21|3.88|
91764132|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|1.97|||||TWO_SIDED|95.0|1.45|2.68||||||||2.68|1.45|
91764133|NCT03197376|183418449|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|5.73|||||TWO_SIDED|95.0|3.8|8.63||||||||8.63|3.80|
91764134|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 1|1.84|||||TWO_SIDED|95.0|1.25|2.72||||||||2.72|1.25|
91764135|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 5|1.14|||||TWO_SIDED|95.0|0.79|1.64||||||||1.64|0.79|
91764136|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6A|68.1|||||TWO_SIDED|95.0|37.07|125.09||||||||125.09|37.07|
91764137|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6B|1.75|||||TWO_SIDED|95.0|1.25|2.46||||||||2.46|1.25|
91764138|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 7F|1.73|||||TWO_SIDED|95.0|1.28|2.34||||||||2.34|1.28|
91764139|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 9V|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||||1.32|0.65|
91544102|NCT04992390|182966906|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|0.46|||<=|0.001|TWO_SIDED|95.0|0.2|0.71||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.71|0.20|<= 0.001
91544103|NCT04992390|182966906|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.61|||<=|0.001|TWO_SIDED|95.0|-0.87|-0.34||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.34|-0.87|<= 0.001
91544104|NCT04992390|182966907|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.5|||>|0.05|TWO_SIDED|95.0|0.64|3.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for Sickness absence (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|3.51|0.64|> .05
91544105|NCT04992390|182966908|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.86|||>|0.05|TWO_SIDED|95.0|-2.2|0.49||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intention to leave job (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.49|-2.20|> .05
91544106|NCT04992390|182966909|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|0.8|||>|0.05|TWO_SIDED|95.0|0.6|1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of days worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|1.07|0.60|>.05
91544107|NCT04992390|182966910|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.09|||<|0.05|TWO_SIDED|95.0|0.57|2.09||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of nights worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|2.09|0.57|<.05
91544108|NCT00130117|182966917|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
91544109|NCT00130117|182966917|SUPERIORITY|||||||0.049|||||||ANOVA|||||||0.049
91544110|NCT00130117|182966918|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.02|TWO_SIDED|||||"p value reflects treatment of leptin for on-treatment, n=4"|ANOVA|||||||0.02
91544111|NCT03358875|182966936|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.527|0.778||OS in the ITT population was tested at one-sided p value boundary of 0.0120.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.778|0.527|<0.0001
91544112|NCT03358875|182966937|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.407|0.702||OS in the PD-L1 positive analysis set was tested at the one-sided p-value boundary of 0.025.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).||||0.702|0.407|<0.0001
91544113|NCT03358875|182966938|SUPERIORITY||Odds Ratio (OR)|3.86|||<|0.0001|TWO_SIDED|95.0|2.336|6.393|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, line of therapy, and PDL1 expression.||||6.393|2.336|<0.0001
91764140|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 14|2.21|||||TWO_SIDED|95.0|1.38|3.51||||||||3.51|1.38|
91764141|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19A|12.54|||||TWO_SIDED|95.0|7.36|21.37||||||||21.37|7.36|
91764142|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19F|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||||1.46|0.70|
91764143|NCT03197376|183418450|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 23F|3.14|||||TWO_SIDED|95.0|2.21|4.45||||||||4.45|2.21|
91764144|NCT03197376|183418451|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for measles|1.7|||||TWO_SIDED|95.0|-3.3|7.4||||||||7.4|-3.3|
91764145|NCT03197376|183418451|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for rubella|1.0|||||TWO_SIDED|95.0|-0.9|4.0||||||||4.0|-0.9|
91764146|NCT03197376|183418451|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for yellow fever|2.4|||||TWO_SIDED|95.0|0.2|5.9||||||||5.9|0.2|
91764147|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 1|16.2|||||TWO_SIDED|95.0|8.0|23.7||||||||23.7|8.0|
91764148|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 5|7.2|||||TWO_SIDED|95.0|-1.4|15.8||||||||15.8|-1.4|
91764149|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6A|30.0|||||TWO_SIDED|95.0|21.8|38.1||||||||38.1|21.8|
91764150|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6B|16.5|||||TWO_SIDED|95.0|10.1|23.6||||||||23.6|10.1|
91764151|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 7F|16.4|||||TWO_SIDED|95.0|8.4|24.5||||||||24.5|8.4|
91764152|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 9V|-0.2|||||TWO_SIDED|95.0|-8.8|8.5||||||||8.5|-8.8|
91764153|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 14|14.7|||||TWO_SIDED|95.0|7.5|22.3||||||||22.3|7.5|
91764154|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19A|14.7|||||TWO_SIDED|95.0|7.3|22.5||||||||22.5|7.3|
91764155|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19F|-13.7|||||TWO_SIDED|95.0|-19.0|-8.0||||||||-8.0|-19.0|
91764156|NCT03197376|183418452|OTHER|Treatment group difference in proportions|Absolute Difference for Type 23F|16.9|||||TWO_SIDED|95.0|8.2|25.4||||||||25.4|8.2|
91764157|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 1 GMC Ratio|1.64|||||TWO_SIDED|95.0|1.42|1.89||||||||1.89|1.42|
91764158|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 5 GMC Ratio|1.2|||||TWO_SIDED|95.0|1.03|1.4||||||||1.40|1.03|
91764159|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6A GMC Ratio|2.36|||||TWO_SIDED|95.0|2.01|2.78||||||||2.78|2.01|
91764160|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6B GMC Ratio|1.45|||||TWO_SIDED|95.0|1.27|1.66||||||||1.66|1.27|
91764161|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 7F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.12|1.49||||||||1.49|1.12|
91764162|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 9V GMC Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
91764163|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 14 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.15|1.72||||||||1.72|1.15|
91544114|NCT03358875|182966939|SUPERIORITY||Odds Ratio (OR)|8.04|||<|0.0001|TWO_SIDED|95.0|3.721|17.379|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology and line of therapy.||||17.379|3.721|<0.0001
91544115|NCT03358875|182966940|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.176|0.536|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.536|0.176|<0.0001
91544116|NCT03358875|182966941|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.066|0.37|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.370|0.066|<0.0001
91544117|NCT03358875|182966942|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.528|0.745|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.745|0.528|<0.0001
91764164|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19A GMC Ratio|1.38|||||TWO_SIDED|95.0|1.14|1.68||||||||1.68|1.14|
91764165|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19F GMC Ratio|0.61|||||TWO_SIDED|95.0|0.5|0.74||||||||0.74|0.50|
91764166|NCT03197376|183418453|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 23F GMC Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.81||||||||1.81|1.24|
91764167|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.05|||||TWO_SIDED|95.0|0.05|0.06||||||||0.06|0.05|
91764168|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.3|||||TWO_SIDED|95.0|0.27|0.33||||||||0.33|0.27|
91544118|NCT03358875|182966943|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.285|0.494|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.494|0.285|<0.0001
91764169|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.16||||||||0.16|0.13|
91764170|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.11||||||||0.11|0.10|
91764171|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.1|||||TWO_SIDED|95.0|0.09|0.11||||||||0.11|0.09|
91764172|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.21|||||TWO_SIDED|95.0|0.19|0.23||||||||0.23|0.19|
91764173|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.17||||||||0.17|0.13|
91764174|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26||||||||0.26|0.20|
91764175|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.15||||||||0.15|0.12|
91764176|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.12||||||||0.12|0.10|
91764177|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.07|||||TWO_SIDED|95.0|0.06|0.08||||||||0.08|0.06|
91764178|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.4|||||TWO_SIDED|95.0|0.35|0.45||||||||0.45|0.35|
91764179|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||||0.86|0.62|
91764180|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
91764181|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.12|||||TWO_SIDED|95.0|0.11|0.13||||||||0.13|0.11|
91764182|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.2|||||TWO_SIDED|95.0|0.18|0.22||||||||0.22|0.18|
91764183|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.19||||||||0.19|0.13|
91544119|NCT03358875|182966944|OTHER||Least Squares (LS) Mean Difference|5.7||||0.0008|TWO_SIDED|95.0|2.38|9.07|||Mixed Models Analysis|||The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||9.07|2.38|0.0008
91544120|NCT03358875|182966945|OTHER||LS Mean Difference|-8.3||||0.0007|TWO_SIDED|95.0|-13.02|-3.51|||Mixed Models Analysis|||Analysis of Change from Baseline in Coughing Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||-3.51|-13.02|0.0007
91764184|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||||0.78|0.52|
91764185|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
91764186|NCT03197376|183418454|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
91764187|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 1|24.2|||||TWO_SIDED|95.0|4.5|42.1||||||||42.1|4.5|
91764188|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 5|9.9|||||TWO_SIDED|95.0|-5.8|25.5||||||||25.5|-5.8|
91764189|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6A|65.6|||||TWO_SIDED|95.0|48.3|78.0||||||||78.0|48.3|
91544121|NCT03358875|182966945|OTHER||LS Mean Difference|-3.2||||0.0579|TWO_SIDED|95.0|-6.52|0.11|||Mixed Models Analysis|||Analysis of Change from Baseline in Dyspnoea Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||0.11|-6.52|0.0579
91764190|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6B|23.2|||||TWO_SIDED|95.0|6.4|39.4||||||||39.4|6.4|
91764191|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 7F|2.0|||||TWO_SIDED|95.0|-5.2|10.8||||||||10.8|-5.2|
91764192|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
91764193|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type14|4.6|||||TWO_SIDED|95.0|-8.5|18.3||||||||18.3|-8.5|
91764194|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19A|34.4|||||TWO_SIDED|95.0|16.5|50.8||||||||50.8|16.5|
91764195|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19F|5.0|||||TWO_SIDED|95.0|-8.4|19.2||||||||19.2|-8.4|
91764196|NCT03197376|183418455|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
91764197|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 1|1.3|||||TWO_SIDED|95.0|0.8|2.1||||||||2.1|0.8|
91764198|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 5|1.3|||||TWO_SIDED|95.0|0.7|2.4||||||||2.4|0.7|
91764199|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6A|14.3|||||TWO_SIDED|95.0|6.3|32.1||||||||32.1|6.3|
91764200|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6B|3.7|||||TWO_SIDED|95.0|2.1|6.8||||||||6.8|2.1|
91764201|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 7F|1.0|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
91764202|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 9V|0.7|||||TWO_SIDED|95.0|0.3|1.7||||||||1.7|0.3|
91764203|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 14|1.1|||||TWO_SIDED|95.0|0.5|2.4||||||||2.4|0.5|
91764204|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19A|5.1|||||TWO_SIDED|95.0|2.4|10.8||||||||10.8|2.4|
91544122|NCT03358875|182966945|OTHER||LS Mean Difference|-2.2||||0.2472|TWO_SIDED|95.0|-6.05|1.56|||Mixed Models Analysis|||Analysis of Change from Baseline in Chest Pain Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||1.56|-6.05|0.2472
91544123|NCT03599648|182966948|SUPERIORITY|||||||0.361||||||baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.361
91544124|NCT03599648|182966948|SUPERIORITY|||||||0.126||||||baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.126
91544125|NCT03599648|182966948|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
91544126|NCT03599648|182966948|SUPERIORITY|||||||0||||||baseline versus immediately after 16 week BPT-M intervention|t-test, 2 sided|||||||.000
91544127|NCT03599648|182966948|SUPERIORITY|||||||0||||||baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
91544128|NCT03599648|182966948|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
91544129|NCT03599648|182966949|SUPERIORITY|||||||0.035||||||Baseline versus immediately following 16-week BPT-E intervention|t-test, 2 sided|||||||.035
91544130|NCT03599648|182966949|SUPERIORITY|||||||0.001||||||Baseline versus 6-months after BPT-E intervention|t-test, 2 sided|||||||.001
91544131|NCT03599648|182966949|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
91544132|NCT03599648|182966949|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
91544133|NCT03599648|182966949|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
91544134|NCT03599648|182966949|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
91544135|NCT03599648|182966950|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.000
91544136|NCT03599648|182966950|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.000
91544137|NCT03599648|182966950|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
91544138|NCT03599648|182966950|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
91544139|NCT03599648|182966950|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
91544140|NCT03599648|182966950|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
91544141|NCT03363854|182966951|SUPERIORITY||Risk Difference (RD)|12.4||||0.015|TWO_SIDED|95.0|2.9|21.9||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||21.9|2.9|0.015
91544142|NCT03363854|182966952|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|9.8|30.6||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||30.6|9.8|<0.001
91544143|NCT03363854|182966953|SUPERIORITY||Risk Difference (RD)|11.3||||0.037|TWO_SIDED|95.0|0.9|21.6||This secondary endpoint was tested after the sequential testing of the primary endpoints, if these showed statistical significance.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.||21.6|0.9|0.037
91544144|NCT03363854|182966954|SUPERIORITY||Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-15.2|-6.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-6.6|-15.2|<0.001
91544145|NCT03363854|182966955|SUPERIORITY||Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-4.3|-1.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints and the first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-1.6|-4.3|<0.001
91764205|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19F|1.0|||||TWO_SIDED|95.0|0.4|2.3||||||||2.3|0.4|
91544146|NCT03363854|182966957|SUPERIORITY||Difference|-3.5||||0.41|TWO_SIDED|95.0|-11.9|4.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||4.9|-11.9|0.41
91544147|NCT03363854|182966957|SUPERIORITY||Difference|-6.9||||0.033|TWO_SIDED|95.0|-13.3|-0.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||-0.6|-13.3|0.033
91544148|NCT03363854|182966957|SUPERIORITY||Difference|-4.7||||0.12|TWO_SIDED|95.0|-10.6|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||1.2|-10.6|0.12
91544149|NCT03363854|182966957|SUPERIORITY||Difference|-7.3||||0.043|TWO_SIDED|95.0|-14.3|-0.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||-0.2|-14.3|0.043
91544150|NCT03363854|182966957|SUPERIORITY||Difference|-9.1||||0.002|TWO_SIDED|95.0|-14.8|-3.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||-3.4|-14.8|0.002
91544151|NCT03363854|182966957|SUPERIORITY||Difference|-8.0||||0.001|TWO_SIDED|95.0|-12.8|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||-3.2|-12.8|0.001
91544152|NCT03363854|182966957|SUPERIORITY||Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.8|-4.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-4.7|-15.8|<0.001
91544153|NCT03363854|182966957|SUPERIORITY||Difference|-8.6||||0.002|TWO_SIDED|95.0|-14.1|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-3.2|-14.1|0.002
91764206|NCT03197376|183418456|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 23F|4.3|||||TWO_SIDED|95.0|2.0|9.4||||||||9.4|2.0|
91544154|NCT03363854|182966958|SUPERIORITY||Difference|0.0||||1|TWO_SIDED|95.0|-11.0|11.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||11.0|-11.0|1.00
91764207|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
91764208|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.11|||||TWO_SIDED|95.0|0.09|0.14||||||||0.14|0.09|
91764209|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.05|||||TWO_SIDED|95.0|0.03|0.08||||||||0.08|0.03|
91764210|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||||0.07|0.03|
91764211|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.26|||||TWO_SIDED|95.0|0.18|0.38||||||||0.38|0.18|
91764212|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.12|||||TWO_SIDED|95.0|0.06|0.23||||||||0.23|0.06|
91764213|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.07|||||TWO_SIDED|95.0|0.05|0.11||||||||0.11|0.05|
91764214|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.16|||||TWO_SIDED|95.0|0.09|0.3||||||||0.30|0.09|
91764215|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.05|0.18||||||||0.18|0.05|
91764216|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.12|||||TWO_SIDED|95.0|0.08|0.18||||||||0.18|0.08|
91764217|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
91764218|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.07|||||TWO_SIDED|95.0|0.05|0.1||||||||0.10|0.05|
91764219|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.21|||||TWO_SIDED|95.0|0.09|0.48||||||||0.48|0.09|
91764220|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.02|||||TWO_SIDED|95.0|0.01|0.03||||||||0.03|0.01|
91544155|NCT03363854|182966958|SUPERIORITY||Difference|1.1||||0.83|TWO_SIDED|95.0|-9.1|11.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||11.4|-9.1|0.83
91544156|NCT03363854|182966958|SUPERIORITY||Difference|-1.4||||0.78|TWO_SIDED|95.0|-11.3|8.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||8.5|-11.3|0.78
91544157|NCT03363854|182966958|SUPERIORITY||Difference|-4.8||||0.34|TWO_SIDED|95.0|-14.8|5.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||5.1|-14.8|0.34
91764221|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.44|||||TWO_SIDED|95.0|0.3|0.65||||||||0.65|0.30|
91764222|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.11|||||TWO_SIDED|95.0|0.06|0.2||||||||0.20|0.06|
91764223|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.11|||||TWO_SIDED|95.0|0.06|0.22||||||||0.22|0.06|
91764224|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.26|||||TWO_SIDED|95.0|0.14|0.49||||||||0.49|0.14|
91764225|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.06|0.14||||||||0.14|0.06|
91764226|NCT03197376|183418457|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.07|||||TWO_SIDED|95.0|0.05|0.12||||||||0.12|0.05|
91764227|NCT01773187|183418468|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||Pre-specified||||0.0003
91764228|NCT01773187|183418469|SUPERIORITY|||||||0.2368|||||||Fisher Exact|||Pre-specified||||0.2368
91764229|NCT00112125|183418476|NON_INFERIORITY|The primary safety analysis was a test of the non-inferiority of CCM therapy compared to OMT with respect to the proportion of subjects experiencing death or hospitalization within 50 weeks using the Blackwelder non-inferiority test12 with a prespecified non-inferiority margin of 0.125.||||||0.31|||||||Fisher Exact|||||||0.31
91764230|NCT00112125|183418477|NON_INFERIORITY|The noninferiority margin was selected to be 12.5% and α was set at .05, which resulted in a sample size of 198 subjects per group. A percentage of subjects (∼7%) were expected to be lost to followup, so that a total sample size of 428 subjects (214 per group) was selected.||||||0.125|||||||Blackwelder|||||||0.125
91764231|NCT00186901|183418485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.86||95.0|||||Wilcoxon Test|||Baseline where N=134||||0.86
91764232|NCT00186901|183418485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.17||||0.99||95.0|||||Wilcoxon Test|||12 Month BMD Z-Score Calculation where N=109||||0.99
91764233|NCT00186901|183418485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.54||95.0|||||Wilcoxon Test|||24 Month BMD Z-Score calculation where N=91||||0.54
91764234|NCT00186901|183418485|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.31||95.0|||||Wilcoxon Test|||36 Month (End of Study) BMD Z-Score calculation where N=84||||0.31
91764235|NCT00186901|183418486|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.32||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
91764236|NCT00186901|183418487|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69||||0.0023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0023
91764237|NCT00186901|183418488|SUPERIORITY_OR_OTHER|||||||0.0092||95.0|||||Kruskal-Wallis|||||||0.0092
91764238|NCT00186901|183418489|SUPERIORITY_OR_OTHER||Correlation coefficient|0.41|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Z-test|||275 received a QCT and 121 received a DXA scan. 121 paired scans were evaluated.||0.55|0.25|<0.0001
91764239|NCT00186901|183418490|SUPERIORITY_OR_OTHER||Correlation coefficient|0.54|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Z-test|||218 patients were assessed at 12 months and received a QCT Scan. 94 patients were also assessed using the DEXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation coefficient.||0.67|0.38|<0.0001
91764240|NCT00186901|183418491|SUPERIORITY_OR_OTHER||Correlation coefficient|0.53|||<|0.0001|TWO_SIDED|95.0|0.36|0.66|||Z-test|||188 patients were assessed at baseline and received a QCT Scan. 90 patients were also assessed using the DEXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation coefficient.||0.66|0.36|<0.0001
91764241|NCT00186901|183418492|SUPERIORITY_OR_OTHER||Correlation coefficient|0.48|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||Z-test|||180 patients were assessed at 36 months and received a QCT Scan. 89 patients were also assessed using the DXA Scan. Comparison of the two methods used 89 paired studies to arrive at a correlation coefficient.||0.63|0.30|<0.0001
91764242|NCT00186901|183418493|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Kruskal Wallis|||||||0.40
91764243|NCT00186901|183418494|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal Wallis|||||||0.21
91764244|NCT00122369|183418496|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant|t-test, 2 sided|||The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.||||0.014
91764245|NCT00122369|183418496|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.421
91764246|NCT00122369|183418496|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.138
91764247|NCT00122369|183418497|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||The null-hypothesis was that there would be no difference among groups.||||0.56
91764248|NCT00122369|183418509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
91544158|NCT03363854|182966958|SUPERIORITY||Difference|-4.4||||0.34|TWO_SIDED|95.0|-13.4|4.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||4.6|-13.4|0.34
91544159|NCT03363854|182966958|SUPERIORITY||Difference|-6.2||||0.11|TWO_SIDED|95.0|-13.9|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||1.5|-13.9|0.11
91544160|NCT03363854|182966958|SUPERIORITY||Difference|-8.9||||0.024|TWO_SIDED|95.0|-16.6|-1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-1.2|-16.6|0.024
91544161|NCT03363854|182966958|SUPERIORITY||Difference|-9.5||||0.017|TWO_SIDED|95.0|-17.3|-1.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-1.7|-17.3|0.017
91544162|NCT03363854|182966960|SUPERIORITY||Difference|0.1||||0.64|TWO_SIDED|95.0|-0.5|0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.||0.7|-0.5|0.64
91544163|NCT03363854|182966960|SUPERIORITY||Difference|0.4||||0.26|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.||1.0|-0.3|0.26
91544164|NCT03363854|182966960|SUPERIORITY||Difference|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.||0.8|-0.4|0.46
91764249|NCT00122369|183418509|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Ordinal regression|||||||0.45
91764250|NCT00122369|183418509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
91764251|NCT00122369|183418509|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
91764252|NCT00122369|183418509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Proportional odds model|||||||<0.001
91764253|NCT00122369|183418509|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
91764254|NCT00122369|183418522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
91764255|NCT00122369|183418522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
91544165|NCT03363854|182966960|SUPERIORITY||Difference|0.4||||0.16|TWO_SIDED|95.0|-0.2|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.||1.0|-0.2|0.16
91764256|NCT00122369|183418522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
91764257|NCT00122369|183418522|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Proportional odds model|||||||0.024
91764258|NCT00122369|183418522|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Proportional odds model|||||||0.018
91764259|NCT00122369|183418522|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Proportional odds model|||||||0.73
91764260|NCT01052077|183418527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and study center as main effects and Week 8 value as convariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
91764261|NCT01052077|183418528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.3778|TWO_SIDED|95.0|-0.69|0.26||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.26|-0.69|0.3778
91764262|NCT01052077|183418529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0162|TWO_SIDED|95.0|-2.38|-0.24||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||-0.24|-2.38|0.0162
91764263|NCT01052077|183418529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0031|TWO_SIDED|95.0|-3.15|-0.65||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||-0.65|-3.15|0.0031
91764264|NCT01052077|183418529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||0.0061|TWO_SIDED|95.0|-3.44|-0.58||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.58|-3.44|0.0061
91764265|NCT01052077|183418529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.0038|TWO_SIDED|95.0|-3.69|-0.72||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.72|-3.69|0.0038
91764266|NCT01052077|183418529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.0174|TWO_SIDED|95.0|-3.32|-0.32||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||-0.32|-3.32|0.0174
91764267|NCT01052077|183418529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
91764268|NCT01052077|183418530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1481|TWO_SIDED|95.0|-0.21|0.03||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||0.03|-0.21|0.1481
91764269|NCT01052077|183418530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0691|TWO_SIDED|95.0|-0.28|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||0.01|-0.28|0.0691
91764270|NCT01052077|183418530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0457|TWO_SIDED|95.0|-0.35|0.0||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.00|-0.35|0.0457
91764271|NCT01052077|183418530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0061|TWO_SIDED|95.0|-0.45|-0.08||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.08|-0.45|0.0061
91764272|NCT01052077|183418530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0572|TWO_SIDED|95.0|-0.38|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||0.01|-0.38|0.0572
91764273|NCT01052077|183418530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3318|TWO_SIDED|95.0|-0.29|0.1||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.10|-0.29|0.3318
91544166|NCT03363854|182966960|SUPERIORITY||Difference|0.5||||0.13|TWO_SIDED|95.0|-0.1|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.||1.1|-0.1|0.13
91544167|NCT03363854|182966960|SUPERIORITY||Difference|0.3||||0.38|TWO_SIDED|95.0|-0.3|0.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.||0.9|-0.3|0.38
91544168|NCT03363854|182966960|SUPERIORITY||Difference|0.6||||0.04|TWO_SIDED|95.0|0.0|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.||1.2|0.0|0.040
91764274|NCT01052077|183418531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.6272|TWO_SIDED|95.0|-1.02|1.69||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||1.69|-1.02|0.6272
91764275|NCT01052077|183418531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9697|TWO_SIDED|95.0|-1.48|1.54||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo||Week 10||1.54|-1.48|0.9697
91764276|NCT01052077|183418531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.749|TWO_SIDED|95.0|-2.0|1.44||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||1.44|-2.00|0.7490
91764277|NCT01052077|183418531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9459|TWO_SIDED|95.0|-1.94|1.81||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||1.81|-1.94|0.9459
91764278|NCT01052077|183418531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9893|TWO_SIDED|95.0|-1.91|1.88||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||1.88|-1.91|0.9893
91764279|NCT01052077|183418531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.8918|TWO_SIDED|95.0|-1.89|2.17||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.17|-1.89|0.8918
91544169|NCT03363854|182966960|SUPERIORITY||Difference|0.3||||0.31|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.||1.0|-0.3|0.31
91764280|NCT01052077|183418532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.3247|TWO_SIDED|95.0|-1.71|0.57||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.57|-1.71|0.3247
91764281|NCT01052077|183418533|SUPERIORITY_OR_OTHER|||||||0.5616||||||Cohran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean: brexpiprazole - placebo.||Week 9||||0.5616
91764282|NCT01052077|183418533|SUPERIORITY_OR_OTHER|||||||0.19||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||||0.1900
91764283|NCT01052077|183418533|SUPERIORITY_OR_OTHER|||||||0.0501||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||||0.0501
91764284|NCT01052077|183418533|SUPERIORITY_OR_OTHER|||||||0.0137||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||||0.0137
91764285|NCT01052077|183418533|SUPERIORITY_OR_OTHER|||||||0.0711||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||||0.0711
91764286|NCT01052077|183418533|SUPERIORITY_OR_OTHER|||||||0.3438||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||||0.3438
91764287|NCT01052077|183418534|SUPERIORITY_OR_OTHER||Ratio of Response rate|2.79||||0.0679|TWO_SIDED|95.0|0.88|8.81|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||8.81|0.88|0.0679
91764288|NCT01052077|183418534|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.78||||0.036|TWO_SIDED|95.0|1.01|3.14|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||3.14|1.01|0.0360
91764289|NCT01052077|183418534|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.53||||0.0521|TWO_SIDED|95.0|0.99|2.35|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.35|0.99|0.0521
91764290|NCT01052077|183418534|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.93||||0.0008|TWO_SIDED|95.0|1.31|2.86|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||2.86|1.31|0.0008
91764291|NCT01052077|183418534|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.64||||0.0074|TWO_SIDED|95.0|1.14|2.38|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.38|1.14|0.0074
91764292|NCT01052077|183418534|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0339|TWO_SIDED|95.0|1.03|2.08|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 14||2.08|1.03|0.0339
91764293|NCT01052077|183418535|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.27||||0.2404|TWO_SIDED|95.0|0.55|9.3|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||9.30|0.55|0.2404
91764294|NCT01052077|183418535|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.04||||0.0983|TWO_SIDED|95.0|0.83|4.98|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||4.98|0.83|0.0983
91764295|NCT01052077|183418535|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0496|TWO_SIDED|95.0|0.99|2.82|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.82|0.99|0.0496
91764296|NCT01052077|183418535|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.12||||0.0019|TWO_SIDED|95.0|1.31|3.46|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||3.46|1.31|0.0019
91764297|NCT01052077|183418535|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.77||||0.0068|TWO_SIDED|95.0|1.17|2.67|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.67|1.17|0.0068
91764298|NCT01052077|183418535|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.71||||0.0089|TWO_SIDED|95.0|1.14|2.57||The CMH general association test controlling for trial center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.57|1.14|0.0089
91764299|NCT01052077|183418536|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.23||||0.4605|TWO_SIDED|95.0|0.7|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 9||2.18|0.70|0.4605
91764300|NCT01052077|183418536|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.2||||0.3267|TWO_SIDED|95.0|0.83|1.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 10||1.72|0.83|0.3267
91544170|NCT03363854|182966960|SUPERIORITY||Difference|1.0||||0.001|TWO_SIDED|95.0|0.4|1.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.||1.6|0.4|0.001
91764301|NCT01052077|183418536|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.37||||0.023|TWO_SIDED|95.0|1.05|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 11||1.80|1.05|0.0230
91764302|NCT01052077|183418536|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.36||||0.0105|TWO_SIDED|95.0|1.08|1.71|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 12||1.71|1.08|0.0105
91764303|NCT01052077|183418536|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.26||||0.0417|TWO_SIDED|95.0|1.01|1.58|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 13||1.58|1.01|0.0417
91764304|NCT01052077|183418536|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.15||||0.2345|TWO_SIDED|95.0|0.91|1.44||CMH general association test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||1.44|0.91|0.2345
91764305|NCT00870545|183418543|SUPERIORITY_OR_OTHER|||||||0.003||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||.003
91764306|NCT00870545|183418544|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 and 12 months)||||.20
91764307|NCT00870545|183418545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||<.001
91764308|NCT00870545|183418546|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, 12 months)||||.26
91764309|NCT00870545|183418547|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in scores over time (baseline, 6 months, and 12 months)||||.04
91764310|NCT00870545|183418548|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, and 12 months)||||.10
91764311|NCT03857542|183418557|SUPERIORITY||Percentage Difference|15.2|||<|0.0001|TWO_SIDED|95.0|7.7|22.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||22.7|7.7|<.0001
91764312|NCT03857542|183418558|SUPERIORITY||Percentage Difference|6.5||||0.0548|TWO_SIDED|95.0|-0.1|13.1||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||13.1|-0.1|0.0548
91764313|NCT03857542|183418559|SUPERIORITY||Percentage Difference|5.9||||0.0693|TWO_SIDED|95.0|-0.5|12.2||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||12.2|-0.5|0.0693
91764314|NCT03857542|183418560|SUPERIORITY||Least Squares (LS) Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|2.9|5.2||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value; Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||5.2|2.9|<.0001
91764315|NCT03857542|183418561|SUPERIORITY||Percentage Difference|9.9||||0.0141|TWO_SIDED|95.0|3.5|16.3||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||16.3|3.5|0.0141
91764316|NCT03857542|183418562|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.5|1.0||Analysis of covariance (ANCOVA) with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control||||1.0|0.5|<.0001
91764317|NCT03857542|183418563|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|2.4|4.4||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||4.4|2.4|<.0001
91764318|NCT03857542|183418564|SUPERIORITY||Percentage Difference|3.8||||0.22|TWO_SIDED|95.0|-2.3|10.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||10.0|-2.3|0.2200
91764319|NCT03857542|183418565|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|1.5|3.7||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||3.7|1.5|<.0001
91764320|NCT03857542|183418566|SUPERIORITY||Percentage Difference|12.4||||0.0141|TWO_SIDED|95.0|5.2|19.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||19.5|5.2|0.0141
91764321|NCT03857542|183418567|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|0.5|1.0||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.0|0.5|<.0001
91764322|NCT03857542|183418568|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08||0.0002|TWO_SIDED|95.0|-0.5|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.5|0.0002
91764323|NCT03857542|183418569|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.4|0.0002
91764324|NCT02709330|183418574|OTHER|||||||0.99|||||||Kolmogorov-Smirnov Test|||Matched historical controls will be identified from the PatientsLikeMe database.||||0.99
91764325|NCT02709330|183418575|OTHER|||||||0.0748|||||||ANOVA|||||||0.0748
91764326|NCT02709330|183418576|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
91764327|NCT02709330|183418580|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
91764328|NCT03152591|183418592|OTHER||Ratio LIK066/Placebo|0.88||||0.353|TWO_SIDED|90.0|0.7|1.11|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline in average fasting free testosterone was analyzed using an analysis of covariance model which included treatment as a categorical factor, baseline body weight and log transformed baseline average fasting free testosterone as a covariate.|1.11|0.70|0.353
91764329|NCT03152591|183418593|OTHER||Ratio LIK066/Placebo|1.25||||0.218|TWO_SIDED|90.0|0.92|1.68|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.68|0.92|0.218
91764330|NCT03152591|183418594|OTHER||Ratio LIK066/Placebo|1.27||||0.249|TWO_SIDED|90.0|0.9|1.78|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.78|0.90|0.249
91764331|NCT03152591|183418595|OTHER||Ratio LIK066/Placebo|1.15||||0.173|TWO_SIDED|90.0|0.97|1.36|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.36|0.97|0.173
91764332|NCT03152591|183418596|OTHER||Ratio LIK066/Placebo|0.82||||0.089|TWO_SIDED|90.0|0.68|0.99|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.99|0.68|0.089
91764333|NCT03152591|183418597|OTHER||Ration LIK066/Placebo|0.69||||0.109|TWO_SIDED|90.0|0.48|1.01|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.01|0.48|0.109
91764334|NCT03152591|183418598|OTHER||Ration LIK066/Placebo|0.76||||0.008|TWO_SIDED|90.0|0.65|0.89|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.89|0.65|0.008
91544171|NCT03363854|182966960|SUPERIORITY||Difference|0.7||||0.026|TWO_SIDED|95.0|0.1|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.||1.3|0.1|0.026
91764335|NCT03152591|183418599|OTHER||Ratio LIK066/Placebo|0.91||||0.34|TWO_SIDED|90.0|0.77|1.07|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.07|0.77|0.340
91764336|NCT03152591|183418600|OTHER||Ratio LIK066/Placebo|0.79||||0.204|TWO_SIDED|90.0|0.58|1.08|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.08|0.58|0.204
91764337|NCT03868254|183418601|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
91764338|NCT03868254|183418601|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
91764339|NCT03868254|183418602|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
91764340|NCT03868254|183418602|OTHER|||||||0.0001|||||||Paired t-test|||||||0.0001
91764341|NCT03868254|183418603|OTHER|||||||0.003|||||||Paired t-test|||||||0.0030
91764342|NCT03868254|183418603|OTHER|||||||0.0018|||||||Paired t-test|||||||0.0018
91764343|NCT03868254|183418604|OTHER|||||||0.0053|||||||Paired t-test|||||||0.0053
91764344|NCT03868254|183418604|OTHER|||||||0.0472|||||||Paired t-test|||||||0.0472
91764345|NCT00786799|183418622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|6.1||0.4|||||||t-test, 2 sided|||The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.||||0.40
91764346|NCT04640311|183418637|OTHER||Geometric mean ratio|1.028|||||TWO_SIDED|90.0|0.9699|1.09|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.090|0.9699|
91764347|NCT04640311|183418637|OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.9602|1.081|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.081|0.9602|
91764348|NCT04640311|183418638|EQUIVALENCE|Bioequivalence was to be determined if the 90 percent (%) confidence interval (CI) of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.029|||||TWO_SIDED|90.0|0.977|1.083|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.083|0.9770|
91764349|NCT04640311|183418638|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9496|||||TWO_SIDED|90.0|0.8914|1.012|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.012|0.8914|
91764350|NCT04640311|183418638|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.9533|1.07|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.070|0.9533|
91764351|NCT04640311|183418638|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9679|||||TWO_SIDED|90.0|0.9115|1.028|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.028|0.9115|
91764352|NCT04640311|183418638|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9511|||||TWO_SIDED|90.0|0.8948|1.011|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||1.011|0.8948|
91764353|NCT04640311|183418639|OTHER||Geometric mean ratio|1.042|||||TWO_SIDED|90.0|0.9308|1.166|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.166|0.9308|
91764354|NCT04640311|183418639|OTHER||Geometric mean ratio|1.048|||||TWO_SIDED|90.0|0.9349|1.175|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.175|0.9349|
91764355|NCT04640311|183418640|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9716|||||TWO_SIDED|90.0|0.8936|1.056|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.056|0.8936|
91764356|NCT04640311|183418640|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9006|||||TWO_SIDED|90.0|0.8107|1.0|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.000|0.8107|
91764357|NCT04640311|183418640|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9703|||||TWO_SIDED|90.0|0.8665|1.087|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.087|0.8665|
91764358|NCT04640311|183418640|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9675|||||TWO_SIDED|90.0|0.8778|1.066|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.066|0.8778|
91764359|NCT04640311|183418640|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.8606|||||TWO_SIDED|90.0|0.777|0.9532|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||0.9532|0.7770|
91764360|NCT03906071|183418651|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.144|TWO_SIDED|95.0|0.7|1.05||The p-value is based on a unstratified log-rank test. (2-Sided)|Log Rank||Based on the unstratified cox proportional hazards model.|||1.05|0.70|0.144
91764361|NCT02152761|183418665|SUPERIORITY||Treatment Group Ratio (BYM - Placebo)|1.057|||<|0.0001|TWO_SIDED|95.0|1.037|1.076|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.076|1.037|<.0001
91764362|NCT02152761|183418665|SUPERIORITY||Treatment group rratio (BYM - Placebo)|1.043|||<|0.0001|TWO_SIDED|95.0|1.024|1.064|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.064|1.024|<.0001
91764363|NCT02152761|183418666|SUPERIORITY||LS Mean of Treatment Difference|-0.071||||0.1829|TWO_SIDED|95.0|-0.175|0.034||Treatment Difference (BYM-Placebo)|Mixed Models Analysis|||week 24||0.034|-0.175|0.1829
91544172|NCT03363854|182966960|SUPERIORITY||Difference|0.9||||0.006|TWO_SIDED|95.0|0.2|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model]|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.||1.5|0.2|0.006
91544173|NCT03363854|182966960|SUPERIORITY||Difference|0.6||||0.043|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.||1.3|0.0|0.043
91544174|NCT03363854|182966960|SUPERIORITY||Difference|0.8||||0.01|TWO_SIDED|95.0|0.2|1.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.||1.4|0.2|0.010
91764364|NCT02152761|183418666|SUPERIORITY||LS Mean of Treatment Difference|0.011||||0.8365|TWO_SIDED|95.0|-0.096|0.119|||Mixed Models Analysis|||week 24||0.119|-0.096|0.8365
91764365|NCT02152761|183418667|SUPERIORITY||LS Mean of Treatment Difference|-0.371||||0.5802|TWO_SIDED|95.0|-1.311|1.053|||Mixed Models Analysis|||week 24||1.053|-1.311|0.5802
91764366|NCT02152761|183418667|SUPERIORITY||LS Mean of the Treatment Difference|0.833||||0.0913|TWO_SIDED|95.0|-0.135|1.801|||Mixed Models Analysis|||week 24||1.801|-0.135|0.0913
91764367|NCT02152761|183418668|SUPERIORITY||Falls Rate Ratio|1.08||||0.8353|TWO_SIDED|95.0|0.53|2.21|||Negative binomial regression|||||2.21|0.53|0.8353
91764368|NCT02152761|183418668|SUPERIORITY||Falls Rate Ratio|1.58||||0.2015|TWO_SIDED|95.0|0.78|3.18|||Negative binomial regression|||||3.18|0.78|0.2015
91764369|NCT02152761|183418668|SUPERIORITY||Falls Rate Ratio|1.25||||0.3999|TWO_SIDED|95.0|0.52|3.0|||Negative binomial regression|||week 24||3.00|0.52|0.3999
91544175|NCT03363854|182966960|SUPERIORITY||Difference|0.7||||0.037|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.||1.3|0.0|0.037
91544176|NCT03363854|182966960|SUPERIORITY||Difference|0.6||||0.045|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.||1.3|0.0|0.045
91764370|NCT02968368|183418697|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0149|TWO_SIDED|95.0|0.102|0.93|||ANCOVA|||||0.930|0.102|0.0149
91764371|NCT02968368|183418702|SUPERIORITY||Mean Difference (Final Values)|39.03|STANDARD_ERROR_OF_MEAN|11.097||0.0006|TWO_SIDED|95.0|17.07|60.992|||ANCOVA|||||60.992|17.070|0.0006
91764372|NCT02968368|183418705|SUPERIORITY||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|1.282||0.0007|TWO_SIDED|95.0|1.928|7.001|||ANCOVA|||||7.001|1.928|0.0007
91764373|NCT02968368|183418706|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.708||0.0098|TWO_SIDED|95.0|0.457|3.261|||ANCOVA|||||3.261|0.457|0.0098
91764374|NCT02859246|183418709|SUPERIORITY||||||<|0.04||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||<0.04
91764375|NCT02859246|183418710|SUPERIORITY||||||<|0.2||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||< 0.2
91764376|NCT00855816|183418722|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||A priori threshold for significance: p\<.05.|Mixed Models Analysis|Mixed model based on intent to treat sample.||Null hypothesis: there will be no differences in PTSD hyperarousal symptom changes in individuals who did receive the experimental intervention vs. those who did not .||||.27
91764377|NCT01526213|183418723|SUPERIORITY_OR_OTHER||Geometric Mean AUC Ratio (GFJ/mGFJ)|0.96||||0.78|TWO_SIDED|90.0|0.4|1.5|||t-test, 2 sided|||For juice comparisons, fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + grapefruit juice will be the reference standard (denominator).||1.5|0.4|0.78
91764378|NCT02562716|183418737|SUPERIORITY|||||||0.15|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.15
91764379|NCT02562716|183418737|SUPERIORITY|||||||0.14|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.14
91764380|NCT04915729|183418753|NON_INFERIORITY|pre-specified non-inferiority margin for risk ratio = 0.937|Risk Ratio (RR)|1.0278|||||TWO_SIDED|95.0|0.9678|1.0915|||Modified Possion Regression Model|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0915|0.9678|
91764381|NCT04915729|183418754|OTHER|log-binomial regression model|Risk Ratio (RR)|1.0671||||0.2412|TWO_SIDED|95.0|0.9573|1.1895||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.1895|0.9573|0.2412
91764382|NCT04915729|183418755|OTHER|Modified Poisson regression model|Risk Ratio (RR)|1.0078||||0.748|TWO_SIDED|95.0|0.9614|1.0564||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0564|0.9614|0.7480
91764383|NCT04915729|183418756|OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.48||0.3511|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|baseline NIHSS, age, time to administration since stroke symptoms onset = linear covariates; treatment = fixed effects|Difference in LSmean tenecteplase vs alteplase|||0.50|-1.40|0.3511
91764384|NCT04915729|183418757|OTHER||Odds Ratio (OR)|1.0418||||0.4806|||||||Regression, Logistic|Assumption-free ordinal analysis|tenecteplase versus alteplase|||||0.4806
91764385|NCT04915729|183418758|OTHER|Poisson regression model|Risk Ratio (RR)|1.0189||||0.5116|TWO_SIDED|95.0|0.9635|1.0774|||Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.0774|0.9635|0.5116
91764386|NCT04915729|183418759|OTHER||Risk Ratio (RR)|1.005||||1|TWO_SIDED|95.0|0.37|2.701|||Suissa-Shuster test||tenecteplase versus alteplase|||2.701|0.370|1.000
91764387|NCT04915729|183418760|OTHER||Risk Ratio (RR)|0.795||||0.303|TWO_SIDED|95.0|0.513|1.232|||Chi-squared||tenecteplase versus alteplase|||1.232|0.513|0.303
91764388|NCT04915729|183418761|OTHER|Modified Poisson regression model|Risk Ratio (RR)|0.9215||||0.6345|TWO_SIDED|95.0|0.6578|1.2908||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.2908|0.6578|0.6345
91764389|NCT03710642|183418885|SUPERIORITY||Mean Difference (Net)|-0.008096||||0.9904|TWO_SIDED||||||Regression, Linear|||||||0.9904
91764390|NCT03710642|183418886|SUPERIORITY||Mean Difference (Net)|-11.54||||0.30328|TWO_SIDED||||||Regression, Linear|||||||0.30328
91764391|NCT03710642|183418887|SUPERIORITY||Mean Difference (Net)|0.31122||||0.21981|TWO_SIDED||||||Regression, Linear|||||||0.21981
91764392|NCT03710642|183418888|SUPERIORITY||Cox Proportional Hazard|-0.36277||||0.6366|TWO_SIDED||||||Regression, Cox|||||||0.6366
91764393|NCT03710642|183418889|SUPERIORITY||Slope|-0.12842|STANDARD_ERROR_OF_MEAN|1.39602||0.9267|TWO_SIDED||||||Regression, Logistic|||||||0.9267
91764394|NCT03710642|183418890|SUPERIORITY||Mean Difference (Net)|3.0694||||0.2038|TWO_SIDED||||||Regression, Linear|||||||0.2038
91764395|NCT03710642|183418891|SUPERIORITY||Mean Difference (Net)|-3.388||||0.54133|TWO_SIDED||||||Regression, Linear|||||||0.54133
91764396|NCT00226811|183418896|SUPERIORITY_OR_OTHER||CBR rate (percentage)|7.7||||||95.0|2.9|16.0|||||Clinical benefit response rate: percent of patients with confirmed complete response, confirmed partial response or stable disease for at least 24 wks according to Response Evaluation Criteria in Solid Tumors, relative to total treated patients|||16.0|2.9|
91764397|NCT00226811|183418901|SUPERIORITY_OR_OTHER||OR rate (percentage)|2.6||||||95.0|0.3|9.0|||||Percentage of patients with confirmed complete response or confirmed partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), relative to the total number of treated patients.|||9.0|0.3|
91764398|NCT01010971|183418927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.0001|TWO_SIDED|95.0|0.59|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.59|<0.0001
91764399|NCT01010971|183418927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|95.0|0.61|1.46||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.46|0.61|<0.0001
91764400|NCT01010971|183418928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.07|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.07|<0.0001
91764401|NCT01010971|183418928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001|TWO_SIDED|95.0|0.08|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.08|<0.0001
91764402|NCT01010971|183418929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.1444|TWO_SIDED|95.0|-0.03|0.71||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.71|-0.03|0.1444
91764403|NCT01010971|183418929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.0124|TWO_SIDED|95.0|0.15|0.89||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.89|0.15|0.0124
91764404|NCT01010971|183418930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.0124|TWO_SIDED|95.0|0.3|0.94||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.94|0.30|0.0124
91764405|NCT01010971|183418930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.33|0.95||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.95|0.33|
91764406|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764407|NCT01128426|183418955|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764408|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .99
91764409|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764410|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .20
91764411|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
91764412|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
91764413|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764414|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .03
91764415|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91544177|NCT03363854|182966960|SUPERIORITY||Difference|0.5||||0.17|TWO_SIDED|95.0|-0.2|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.||1.1|-0.2|0.17
91764416|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764417|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764418|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
91764419|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764420|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91764421|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764422|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91764423|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91764424|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764425|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91764426|NCT01128426|183418955|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764427|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764428|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764429|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764430|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764431|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764432|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764433|NCT01128426|183418955|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764434|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764435|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
91764436|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764437|NCT01128426|183418955|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764438|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
91764439|NCT01128426|183418955|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764440|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764441|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764442|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
91764443|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
91544178|NCT03363854|182966961|SUPERIORITY||Risk Difference (RD)|21.3|||<|0.001|TWO_SIDED|95.0|11.3|31.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||31.3|11.3|<0.001
91544179|NCT03363854|182966962|SUPERIORITY||Risk Difference (RD)|11.4||||0.022|TWO_SIDED|95.0|2.1|20.7||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||20.7|2.1|0.022
91544180|NCT03363854|182966963|SUPERIORITY||Difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.7|-3.1||The statistical test was not controlled for multiplicity.|Repeated measurement model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-3.1|-7.7|<0.001
91764444|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
91764445|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764446|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764447|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
91764448|NCT01128426|183418955|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764449|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764450|NCT01128426|183418955|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764451|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764452|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764453|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764454|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764455|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764456|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764457|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
91764458|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
91764459|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764460|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
91764461|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
91764462|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
91764463|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
91764464|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764465|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764466|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764467|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
91764468|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91544181|NCT03363854|182966964|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|12.4|33.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||33.3|12.4|<0.001
91544182|NCT03363854|182966965|SUPERIORITY||Risk Difference (RD)|11.1||||0.012|TWO_SIDED|95.0|3.2|19.0||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||19.0|3.2|0.012
91544183|NCT03363854|182966966|SUPERIORITY||Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-0.7|-1.7|<0.001
91544184|NCT03363854|182966967|SUPERIORITY||Risk Difference (RD)|17.6|||<|0.001|TWO_SIDED|95.0|8.0|27.1||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.||27.1|8.0|<0.001
91544185|NCT05332340|182967023|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.683|TWO_SIDED||||||Kruskal-Wallis|||||||0.683
91544186|NCT06375421|182967033|SUPERIORITY|For preliminary efficacy, we used paired-samples t-tests within each group to compare free recall at the 1-week assessment between the two schedules.|Mean Difference (Net)|5.0|||<|0.001|TWO_SIDED||||||t-test, 2 sided|degrees of freedom: 17|Preliminary Intervention Effect = MEMI Free Recall - Blocked Free Recall|||||<0.001
91544187|NCT06375421|182967033|SUPERIORITY|For preliminary efficacy, we used paired-samples t-tests within each group to compare free recall at the 1-week assessment between the two schedules.|Mean Difference (Net)|6.8|||<|0.001|TWO_SIDED||||||t-test, 2 sided|degrees of freedom: 19|Preliminary Intervention Effect = MEMI Free Recall - Blocked Free Recall|||||<0.001
91544188|NCT06375421|182967034|SUPERIORITY|We used paired-samples t-tests within each group to compare cued word recall at the 1-week assessment between the two schedules.|Mean Difference (Net)|5.2|||<|0.001|TWO_SIDED||||||t-test, 2 sided|degrees of freedom: 17|Preliminary Intervention Effect = MEMI Cued Word Recall - Blocked Cued Word Recall|||||<0.001
91544189|NCT06375421|182967034|SUPERIORITY|We used paired-samples t-tests within each group to compare cued word recall at the 1-week assessment between the two schedules.|Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|degrees of freedom: 19|Preliminary Intervention Effect = MEMI Cued Word Recall - Blocked Cued Word Recall|||||<0.001
91544190|NCT06375421|182967035|SUPERIORITY|We used paired-samples t-tests within each group to compare cued definition recall at the 1-week assessment between the two schedules.|Mean Difference (Net)|3.6||||0.003|TWO_SIDED||||||t-test, 2 sided|degrees of freedom: 17|Preliminary Intervention Effect = MEMI Cued Definition Recall - Blocked Cued Definition Recall|||||0.003
91544191|NCT06375421|182967035|SUPERIORITY|We used paired-samples t-tests within each group to compare cued definition recall at the 1-week assessment between the two schedules.|Mean Difference (Net)|3.3||||0.002|TWO_SIDED||||||t-test, 2 sided|degrees of freedom: 19|Preliminary Intervention Effect = MEMI Cued Definition Recall - Blocked Cued Definition Recall|||||0.002
91544192|NCT03702725|182967037|OTHER||||||||||||||||||Estimate value DL 3|||
91544193|NCT00956007|182967049|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0747|TWO_SIDED|95.0|0.6|1.08||One-sided significance level = 0.0183|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|This trial was designed to detect a hazard ratio (HR) of 0.74 with 80% statistical power and overall one-sided alpha of 0.025 (372 deaths) using a stratified log-rank test, assuming a control arm 3-year survival rate of 60.1%. The amended protocol based on ≥ 5 years potential follow-up projected 169 events, providing 55%, 66%, and 79% power to detect HRs of 0.71, 0.68, and 0.64, respectively, using the original one-sided alpha of 0.0183 the final analysis.||1.08|0.60|0.0747
91544194|NCT00956007|182967050|SUPERIORITY|||||||0.0075|||||||Fisher Exact|||Dysphagia||||0.0075
91544195|NCT00956007|182967050|SUPERIORITY|||||||0.2955|||||||Fisher Exact|||Dry mouth||||0.2955
91544196|NCT00956007|182967050|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Dermatitis radiation||||0.0001
91544197|NCT00956007|182967050|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Rach acneiform||||<0.0001
91544198|NCT00956007|182967051|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91544199|NCT00956007|182967052|SUPERIORITY|||||||0.1641|||||||Fisher Exact|||Dysphagia||||0.1641
91544200|NCT00956007|182967052|SUPERIORITY|||||||0.2623|||||||Fisher Exact|||Dry mouth||||0.2623
91544201|NCT00956007|182967052|SUPERIORITY|||||||0.5378|||||||Fisher Exact|||Dermatitis radiation||||0.5378
91544202|NCT00956007|182967052|SUPERIORITY|||||||0.057|||||||Fisher Exact|||Rash acneiform||||0.0570
91544203|NCT00956007|182967053|SUPERIORITY|||||||0.1575|||||||Fisher Exact|||||||0.1575
91544204|NCT00956007|182967054|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0168|TWO_SIDED|95.0|0.57|0.98||One-sided|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|||0.98|0.57|0.0168
91544205|NCT05228470|182967064|OTHER|Null hypothesis of ORR by BICR was 30%.||||||0.0076|||||||Exact binomial test|||||||0.0076
91544206|NCT06511076|182967122|EQUIVALENCE|Bioequivalence was concluded if the 90% CIs for the ratio of the geometric means of Treatment ZLP-AI (test \[T\]) / Treatment ZLP-PFS (Reference \[R\]) were included in the range from 0.80 - 1.25.|GLSM ratio|0.9809||||||90.0|0.9529|1.0097|||Mixed Effects model||The GLSM ratio was calculated: ZLP-AI/ZLP-PFS|||1.0097|0.9529|
91544207|NCT06511076|182967123|EQUIVALENCE|Bioequivalence was concluded if the 90% CIs for the ratio of the geometric means of Treatment ZLP-AI (test \[T\]) / Treatment ZLP-PFS (Reference \[R\]) were included in the range from 0.80 - 1.25.|GLSM Ratio|0.9819|||||TWO_SIDED|90.0|0.9543|1.0102|||Mixed Effects model||The GLSM ratio was calculated: ZLP-AI/ZLP-PFS|||1.0102|0.9543|
91764469|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91544208|NCT06511076|182967124|EQUIVALENCE|Bioequivalence was concluded if the 90% CIs for the ratio of the geometric means of Treatment ZLP-AI (test \[T\]) / Treatment ZLP-PFS (Reference \[R\]) were included in the range from 0.80 - 1.25.|GLSM ratio|0.9996|||||TWO_SIDED|90.0|0.9594|1.0416|||Mixed Effects model||The GLSM ratio was calculated: ZLP-AI/ZLP-PFS|||1.0416|0.9594|
91544209|NCT00431834|182967129|SUPERIORITY_OR_OTHER||binomial proportions|37.7|||<|0.0041|ONE_SIDED|97.5|25.6|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||25.6|<0.0041
91544210|NCT00431834|182967132|SUPERIORITY_OR_OTHER||binomial proportions|5.3|||<|0.0001|ONE_SIDED|97.5||13.1||The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.|Fisher Exact|||"The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p \< 23.6%"||13.1||<0.0001
91544211|NCT04191499|182967146|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.32|0.59|||Log Rank|||Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.||0.59|0.32|<0.0001
91544212|NCT00895531|182967160|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
91544213|NCT02253537|182967177|EQUIVALENCE|2 x 2 contingency table with 95% CI.|2 x 2 contingency table|86.7|||||TWO_SIDED|95.0|62.1|96.3||||||||96.3|62.1|
91544214|NCT05999435|182967181|SUPERIORITY||Least Square Means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.1||0.4463|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||"Null hypothesis of no difference; statistical results of observed PCS and change from baseline PCS are identical."||||0.4463
91544215|NCT05999435|182967181|SUPERIORITY||Least Square Means difference|0.2|STANDARD_ERROR_OF_MEAN|1.1||0.8707|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||"Null hypothesis of no difference; statistical results of observed PCS and change from baseline PCS are identical."||||0.8707
91544216|NCT05999435|182967181|SUPERIORITY||Least Square Means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.11||0.36|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||"Null hypothesis of no difference; statistical results of observed PCS and change from baseline PCS are identical."||||0.3600
91544217|NCT05999435|182967184|SUPERIORITY|||||||0.1618||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.1618
91544218|NCT05999435|182967184|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||1.000
91544219|NCT05999435|182967184|SUPERIORITY|||||||0.1027|||||||Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.1027
91544220|NCT05999435|182967184|SUPERIORITY|||||||0.0229|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.0229
91544221|NCT05999435|182967184|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||1.000
91544222|NCT05999435|182967184|SUPERIORITY|||||||0.0296|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.0296
91544223|NCT05999435|182967184|SUPERIORITY|||||||0.8448|||||||Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.8448
91544224|NCT05999435|182967184|SUPERIORITY|||||||0.0307|||||||Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.0307
91544225|NCT05999435|182967184|SUPERIORITY|||||||0.0105|||||||Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.0105
91544226|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|1.6|STANDARD_ERROR_OF_MEAN|1.3||0.2217|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.2217
91544227|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|-0.5|STANDARD_ERROR_OF_MEAN|1.3||0.6834|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.6834
91544228|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|2.1|STANDARD_ERROR_OF_MEAN|1.31||0.1061|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.1061
91544229|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|2.2|STANDARD_ERROR_OF_MEAN|1.3||0.0854|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.0854
91544230|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.6686|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.6686
91544231|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|2.8|STANDARD_ERROR_OF_MEAN|1.31||0.0331|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.0331
91544232|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.29||0.4327|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 12 comparison, null hypothesis of no difference||||0.4327
91544233|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|-2.0|STANDARD_ERROR_OF_MEAN|1.29||0.1247|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 12 comparison, null hypothesis of no difference||||0.1247
91544234|NCT05999435|182967185|SUPERIORITY||Least Square Means difference|1.0|STANDARD_ERROR_OF_MEAN|1.31||0.4606|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 12 comparison, null hypothesis of no difference||||0.4606
91544235|NCT05999435|182967186|SUPERIORITY|||||||0.7807||||||Alpha set at 0.05|Fisher Exact|||Baseline comparison, null hypothesis of no difference||||0.7807
91544236|NCT05999435|182967186|SUPERIORITY|||||||0.4965||||||Alpha set at 0.05|Fisher Exact|||Baseline comparison, null hypothesis of no difference||||0.4965
91544237|NCT05999435|182967186|SUPERIORITY|||||||0.2093||||||Alpha set at 0.05|Fisher Exact|||Baseline comparison, null hypothesis of no difference||||0.2093
91544238|NCT05999435|182967186|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544239|NCT05999435|182967186|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544240|NCT05999435|182967186|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544241|NCT05999435|182967187|SUPERIORITY||Least Square Means difference|0.4|STANDARD_ERROR_OF_MEAN|1.11||0.7052|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.7052
91544242|NCT05999435|182967187|SUPERIORITY||Least Square Means difference|1.8|STANDARD_ERROR_OF_MEAN|1.11||0.115|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.1150
91544243|NCT05999435|182967187|SUPERIORITY||Least Square Means difference|-1.3|STANDARD_ERROR_OF_MEAN|1.11||0.2296|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.2296
91544244|NCT05999435|182967187|SUPERIORITY||Least Square Means difference|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.7761|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.7761
91544245|NCT05999435|182967187|SUPERIORITY||Least Square Means difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.8544|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.8544
91544246|NCT05999435|182967187|SUPERIORITY||Least Square Means difference|0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9197|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.9197
91544247|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-1.2|STANDARD_ERROR_OF_MEAN|2.5||0.6269|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Vitality domain, Week 12 comparison, null hypothesis of no difference||||0.6269
91544248|NCT05999435|182967188|SUPERIORITY||Leat Square Means difference|-1.9|STANDARD_ERROR_OF_MEAN|2.5||0.4427|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Vitality domain, Week 12 comparison, null hypothesis of no difference||||0.4427
91544249|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|0.7|STANDARD_ERROR_OF_MEAN|2.52||0.7783|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Vitality domain, Week 12 comparison, null hypothesis of no difference||||0.7783
91544250|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-1.0|STANDARD_ERROR_OF_MEAN|3.19||0.7488|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Physical Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.7488
91764470|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764471|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764472|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91544251|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|1.9|STANDARD_ERROR_OF_MEAN|3.18||0.5557|TWO_SIDED||||||Mixed Models Analysis|||Physical Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.5557
91764473|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
91544252|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-2.9|STANDARD_ERROR_OF_MEAN|3.22||0.3679|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Physical Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.3679
91544253|NCT05999435|182967188|SUPERIORITY||Least Squre Means difference|-8.0|STANDARD_ERROR_OF_MEAN|2.78||0.0044|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Bodily Pain domain, Week 12 comparison, null hypothesis of no difference||||0.0044
91544254|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-6.8|STANDARD_ERROR_OF_MEAN|2.79||0.0158|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Bodily Pain domain, Week 12 comparison, null hypothesis of no difference||||0.0158
91544255|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-1.2|STANDARD_ERROR_OF_MEAN|2.81||0.6682|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Bodily Pain domain, Week 12 comparison, null hypothesis of no difference||||0.6682
91764474|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91544256|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|2.2|STANDARD_ERROR_OF_MEAN|1.9||0.2448|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||General Health domain, Week 12 comparison, null hypothesis of no difference||||0.2448
91544257|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|1.4|STANDARD_ERROR_OF_MEAN|1.9||0.4702|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||General Health domain, Week 12 comparison, null hypothesis of no difference||||0.4702
91544258|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|0.8|STANDARD_ERROR_OF_MEAN|1.92||0.6627|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||General Health domain, Week 12 comparison, null hypothesis of no difference||||0.6627
91544259|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-3.1|STANDARD_ERROR_OF_MEAN|2.85||0.2774|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Role Physical Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.2774
91544260|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-4.1|STANDARD_ERROR_OF_MEAN|2.85||0.1537|TWO_SIDED||||||Mixed Models Analysis|||Role Physical Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.1537
91764475|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91544261|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|1.0|STANDARD_ERROR_OF_MEAN|2.87||0.7355|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Role Physical Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.7355
91544262|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-8.0|STANDARD_ERROR_OF_MEAN|5.9||0.1757|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Role Emotional Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.1757
91544263|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-10.9|STANDARD_ERROR_OF_MEAN|5.89||0.0649|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Rome Emotional Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.0649
91544264|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|2.9|STANDARD_ERROR_OF_MEAN|5.93||0.6262|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Role Emotional Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.6262
91544265|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|0.1|STANDARD_ERROR_OF_MEAN|2.92||0.9709|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Social Role Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.9709
91544266|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-2.9|STANDARD_ERROR_OF_MEAN|2.92||0.3201|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Social Role Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.3201
91544267|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|3.0|STANDARD_ERROR_OF_MEAN|2.95||0.3065|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Social Role Functioning domain, Week 12 comparison, null hypothesis of no difference||||0.3065
91544268|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|1.0|STANDARD_ERROR_OF_MEAN|0.95||0.2891|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Mental Health domain, Week 12 comparison, null hypothesis of no difference||||0.2891
91544269|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8714|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Mental Health domain, Week 12 comparison, null hypothesis of no difference||||0.8714
91544270|NCT05999435|182967188|SUPERIORITY||Least Square Means difference|1.2|STANDARD_ERROR_OF_MEAN|0.96||0.226|TWO_SIDED|||||Alpha set at 0.05|Mixed Models Analysis|||Mental Health domain, Week 12 comparison, null hypothesis of no difference||||0.2260
91544271|NCT05999435|182967189|SUPERIORITY|||||||||||||||||Week 4 comparison, null hypothesis of no difference|No comparison possible since zero count in both groups|||
91544272|NCT05999435|182967189|SUPERIORITY|||||||0.2459||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.2459
91544273|NCT05999435|182967189|SUPERIORITY|||||||0.2459||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.2459
91544274|NCT05999435|182967189|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||1.000
91544275|NCT05999435|182967189|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||1.000
91544276|NCT05999435|182967189|SUPERIORITY|||||||||||||||||Week 8 comparison, null hypothesis of no difference|No comparison possible since zero count in both groups|||
91544277|NCT05999435|182967189|SUPERIORITY|||||||0.4972||||||Alpha set to 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.4972
91544278|NCT05999435|182967189|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544279|NCT05999435|182967189|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544280|NCT05999435|182967190|SUPERIORITY|||||||0.3081||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.3081
91764476|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764477|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91764478|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764479|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
91764480|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
91764481|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
91764482|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
91544281|NCT05999435|182967190|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||1.000
91764483|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
91764484|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91544282|NCT05999435|182967190|SUPERIORITY|||||||0.3081|||||||Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.3081
91544283|NCT05999435|182967190|SUPERIORITY|||||||0.066||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.066
91544284|NCT05999435|182967190|SUPERIORITY|||||||0.0297||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.0297
91544285|NCT05999435|182967190|SUPERIORITY|||||||0.8471||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.8471
91544286|NCT05999435|182967190|SUPERIORITY|||||||0.7009||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.7009
91544287|NCT05999435|182967190|SUPERIORITY|||||||0.7064||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.7064
91544288|NCT05999435|182967190|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544289|NCT05999435|182967191|SUPERIORITY|||||||0.1686|||||||Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.1686
91544290|NCT05999435|182967191|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||1.000
91544291|NCT05999435|182967191|SUPERIORITY|||||||0.0643||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.0643
91544292|NCT05999435|182967191|SUPERIORITY|||||||0.1531|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.1531
91764485|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764486|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764487|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91544293|NCT05999435|182967191|SUPERIORITY|||||||0.7187|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.7187
91544294|NCT05999435|182967191|SUPERIORITY|||||||0.072||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.0720
91544295|NCT05999435|182967191|SUPERIORITY|||||||0.6117||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.6117
91544296|NCT05999435|182967191|SUPERIORITY|||||||0.0479||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.0479
91544297|NCT05999435|182967191|SUPERIORITY|||||||0.2042||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.2042
91544298|NCT05999435|182967192|SUPERIORITY|||||||0.2458||||||Alpha set at 0.05|Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.2458
91764488|NCT01128426|183418956|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764489|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
91764490|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
91764491|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764492|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764493|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
91764494|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
91764495|NCT01128426|183418956|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
91764496|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
91764497|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764498|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764499|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764500|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
91764501|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764502|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
91764503|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
91764504|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764505|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764506|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
91764507|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764508|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764509|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
91764510|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764511|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764512|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764513|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764514|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764515|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764516|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764517|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
91764518|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764519|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764520|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91544299|NCT05999435|182967192|SUPERIORITY|||||||||||||||||Week 4 comparison, null hypothesis of no difference|Comparison not possible since zero counts in both groups|||
91544300|NCT05999435|182967192|SUPERIORITY|||||||0.2458|||||||Fisher Exact|||Week 4 comparison, null hypothesis of no difference||||0.2458
91544301|NCT05999435|182967192|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||1.000
91544302|NCT05999435|182967192|SUPERIORITY|||||||0.4944||||||Alpha set at 0.05|Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.4944
91764521|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764522|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764523|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764524|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
91764525|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764526|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764527|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764528|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91544303|NCT05999435|182967192|SUPERIORITY|||||||0.4798|||||||Fisher Exact|||Week 8 comparison, null hypothesis of no difference||||0.4798
91544304|NCT05999435|182967192|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||1.000
91544305|NCT05999435|182967192|SUPERIORITY|||||||0.4972||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.4972
91544306|NCT05999435|182967192|SUPERIORITY|||||||0.4885||||||Alpha set at 0.05|Fisher Exact|||Week 12 comparison, null hypothesis of no difference||||0.4885
91544307|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.4156|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.4156
91544308|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.7088|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.7088
91544309|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.661|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 4 comparison, null hypothesis of no difference||||0.6610
91764529|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
91764530|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764531|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764532|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764533|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764534|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764535|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
91764536|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
91764537|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764538|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
91764539|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764540|NCT01128426|183418957|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91544310|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.758|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.7580
91544311|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.4974|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.4974
91544312|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.3289|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 8 comparison, null hypothesis of no difference||||0.3289
91544313|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.17|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 12 comparison, null hypothesis of no difference||||0.1700
91544314|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.0557|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 12 comparison, null hypothesis of no difference||||0.0557
91544315|NCT05999435|182967193|SUPERIORITY||Least Square Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.6008|TWO_SIDED|||||No adjustment for multiple comparisons, alpha set at 0.05|Mixed Models Analysis|||Week 12 comparison, null hypothesis of no difference||||0.6008
91764541|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91544316|NCT05999435|182967194|SUPERIORITY|||||||0.8046||||||Alpha set at 0.05|Fisher Exact|||Null hypothesis of no difference||||0.8046
91544317|NCT05999435|182967194|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Null hypothesis of no difference||||1.000
91764542|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
91764543|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764544|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764545|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764546|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
91764547|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764548|NCT01128426|183418957|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
91764549|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764550|NCT01128426|183418958|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764551|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764552|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
91764553|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
91764554|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91544318|NCT05999435|182967194|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Null hypothesis of no difference||||1.000
91544319|NCT05999435|182967196|SUPERIORITY|||||||||||||||||Null hypothesis of no difference|Sustained recovery was not achieved in any participant, no possible statistical analysis|||
91764555|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764556|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
91764557|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764558|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91544320|NCT05999435|182967197|SUPERIORITY|||||||0.7699||||||Treatment group effect, alpha set at 0.05|ANOVA|||Week 4 comparison, null hypothesis of no difference||||0.7699
91544321|NCT05999435|182967197|SUPERIORITY|||||||0.9928||||||Treatment group effect, alpha set at 0.05|ANOVA|||Week 8 comparison, null hypothesis of no difference||||0.9928
91544322|NCT05999435|182967197|SUPERIORITY|||||||0.8363||||||Treatment group effect, alpha set at 0.05|ANOVA|||Week 12 comparison, null hypothesis of no difference||||0.8363
91544323|NCT05999435|182967197|SUPERIORITY|||||||0.693||||||Treatment group effect, alpha set at 0.05|ANOVA|||Week 24 comparison, null hypothesis of no difference||||0.6930
91544324|NCT05999435|182967198|SUPERIORITY|||||||0.278||||||Alpha set at 0.05|Fisher Exact|||Null hypothesis of no difference||||0.2780
91544325|NCT05999435|182967198|SUPERIORITY|||||||0.4967||||||Alpha set at 0.05|Fisher Exact|||Null hypothesis of no difference||||0.4967
91544326|NCT05999435|182967198|SUPERIORITY|||||||1||||||Alpha set at 0.05|Fisher Exact|||Null hypothesis of no difference||||1.000
91544327|NCT04982315|182967260|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.024|TWO_SIDED|95.0|-1.9|-0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||||-0.1|-1.9|.024
91544328|NCT04982315|182967260|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.001|TWO_SIDED|95.0|-2.5|-0.6|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||||-0.6|-2.5|.001
91544329|NCT04982315|182967260|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.286|TWO_SIDED|95.0|-1.5|0.5|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||||0.5|-1.5|.286
91544330|NCT04982315|182967261|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0|TWO_SIDED|95.0|-2.1|-0.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||-0.7|-2.1|0
91544331|NCT04982315|182967261|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.008|TWO_SIDED|95.0|-2.1|-0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-0.3|-2.1|.008
91544332|NCT04982315|182967261|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0|TWO_SIDED|95.0|-2.6|-0.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-0.7|-2.6|0
91544333|NCT04982315|182967261|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.27|TWO_SIDED|95.0|-1.4|0.4|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.4|-1.4|.27
91764559|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764560|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764561|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
91764562|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764563|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
91764564|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
91764565|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
91764566|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91764567|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764568|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764569|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
91764570|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764571|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764572|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
91764573|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764574|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764575|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91544334|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.4|||<|0.001|TWO_SIDED|95.0|1.15|1.72|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||1.72|1.15|<.001
91544335|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.33||||0.022|TWO_SIDED|95.0|1.04|1.7|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 6 months||1.70|1.04|.022
91544336|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.49|||<|0.001|TWO_SIDED|95.0|1.19|1.86|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 6 months||1.86|1.19|<.001
91544337|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.12||||0.36|TWO_SIDED|95.0|0.88|1.43|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 6 months||1.43|.88|.36
91544338|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.33||||0.012|TWO_SIDED|95.0|1.06|1.66|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 12 months||1.66|1.06|.012
91764576|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
91764577|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764578|NCT01128426|183418958|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764579|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
91764580|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764581|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
91764582|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764583|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764584|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764585|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
91764586|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
91764587|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91764588|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
91764589|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
91764590|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
91764591|NCT01128426|183418958|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764592|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
91764593|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
91764594|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764595|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764596|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764597|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764598|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
91764599|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764600|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91764601|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764602|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764603|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
91764604|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764605|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91764606|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91544339|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.54|||<|0.001|TWO_SIDED|95.0|1.25|1.91|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 12 months||1.91|1.25|<.001
91764607|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
91764608|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91764609|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
91764610|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91544340|NCT04982315|182967262|SUPERIORITY||Risk Ratio (RR)|1.16||||0.076|TWO_SIDED|95.0|0.98|1.37|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 12 months||1.37|.98|.076
91544341|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0|TWO_SIDED|95.0|-1.1|-0.5|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||-0.5|-1.1|0
91544342|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.019|TWO_SIDED|95.0|-0.8|-0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-0.1|-0.8|.019
91544343|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0|TWO_SIDED|95.0|-1.3|-0.6|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-0.6|-1.3|0
91544344|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.02|TWO_SIDED|95.0|-0.9|-0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-0.1|-0.9|.02
91544345|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-0.8|-0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-0.1|-0.8|.02
91764611|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764612|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
91764613|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
91764614|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91544346|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0|TWO_SIDED|95.0|-1.0|-0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-0.3|-1|0
91544347|NCT04982315|182967263|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.22|TWO_SIDED|95.0|-0.6|0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||0.1|-0.6|.22
91544348|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.76||||0|TWO_SIDED|95.0|1.39|2.24|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||2.24|1.39|0
91764615|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764616|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
91764617|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764618|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764619|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764620|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
91764621|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
91764622|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
91764623|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
91764624|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764625|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91544349|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.19||||0.14|TWO_SIDED|95.0|0.94|1.5|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 6 months||1.50|.94|.14
91544350|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.38||||0.006|TWO_SIDED|95.0|1.1|1.73|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 6 months||1.73|1.10|.006
91764626|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764627|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764628|NCT01128426|183418959|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764629|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
91764630|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764631|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764632|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764633|NCT01128426|183418959|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764634|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
91764635|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764636|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764637|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764638|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
91764639|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764640|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764641|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
91764642|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764643|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764644|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
91764645|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
91764646|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764647|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
91764648|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764649|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
91764650|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
91764651|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
91764652|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||1|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||1.00
91764653|NCT01128426|183418960|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91544351|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.16||||0.167|TWO_SIDED|95.0|0.94|1.42|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 6 months||1.42|.94|.167
91544352|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.22||||0.089|TWO_SIDED|95.0|0.97|1.52|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 12 months||1.52|.97|.089
91544353|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.21||||0.12|TWO_SIDED|95.0|0.95|1.55|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 12 months||1.55|.95|.12
91544354|NCT04982315|182967264|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.8|1.25|||Wald Test, 2-sided|Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE.||Difference in change from baseline at 12 months||1.25|.80|.99
91544355|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.025|TWO_SIDED|95.0|0.1|1.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||1.7|.1|.025
91544356|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.747|TWO_SIDED|95.0|-0.8|1.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1.1|-0.8|.747
91544357|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.1|TWO_SIDED|95.0|-0.1|1.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1.7|-.1|.1
91544358|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.22|TWO_SIDED|95.0|-0.4|1.6|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1.6|-.4|.22
91544359|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.162|TWO_SIDED|95.0|-0.3|1.6|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||1.6|-.3|.162
91544360|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.277|TWO_SIDED|95.0|-0.4|1.4|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||1.4|-.4|.277
91764654|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
91764655|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
91764656|NCT01128426|183418960|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764657|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
91764658|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764659|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764660|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764661|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764662|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
91764663|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764664|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764665|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91764666|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764667|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764668|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764669|NCT01128426|183418960|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764670|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764671|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764672|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764673|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764674|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764675|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764676|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
91764677|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764678|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
91764679|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91764680|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91764681|NCT01128426|183418960|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764682|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
91764683|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764684|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764685|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764686|NCT01128426|183418960|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764687|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764688|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
91764689|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764690|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764691|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764692|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764693|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764694|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
91764695|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764696|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
91764697|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764698|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764699|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764700|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764701|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91764702|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
91764703|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764704|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91764705|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
91764706|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
91764707|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
91764708|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764709|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764710|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764711|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764712|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764713|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764714|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
91764715|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91544361|NCT04982315|182967265|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.68|TWO_SIDED|95.0|-1.0|0.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.7|-1|.68
91764716|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764717|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
91764718|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764719|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764720|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764721|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
91764722|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91544362|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|1.2||||0|TWO_SIDED|95.0|0.9|1.4|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||1.4|0.9|0
91764723|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764724|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764725|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764726|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764727|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764728|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
91764729|NCT01128426|183418961|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764730|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764731|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764732|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91764733|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764734|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764735|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
91764736|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764737|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
91764738|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
91764739|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
91764740|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
91764741|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764742|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91764743|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91764744|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764745|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764746|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91764747|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764748|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764749|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764750|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
91764751|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764752|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764753|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764754|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764755|NCT01128426|183418962|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764756|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764757|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764758|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
91764759|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
91764760|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764761|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764762|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764763|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764764|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764765|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
91764766|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91764767|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764768|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764769|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764770|NCT01128426|183418962|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764771|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764772|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
91764773|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764774|NCT01128426|183418963|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764775|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764776|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764777|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764778|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764779|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764780|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
91764781|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
91764782|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.39|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.39
91764783|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
91764784|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91764785|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764786|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764787|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
91764788|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91764789|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764790|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
91764791|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
91764792|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
91764793|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
91764794|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
91764795|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
91764796|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764797|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764798|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91544363|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|0.7||||0|TWO_SIDED|95.0|0.4|1.0|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1|.4|0
91544364|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|1.3||||0|TWO_SIDED|95.0|1.0|1.5|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1.5|1|0
91544365|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|0.6||||0|TWO_SIDED|95.0|0.3|0.9|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.9|.3|0
91544366|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|0.5||||0|TWO_SIDED|95.0|0.2|0.8|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.8|.2|0
91544367|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|0.8||||0|TWO_SIDED|95.0|0.5|1.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||1.1|.5|0
91513982|NCT00489970|182899991|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.24|||||TWO_SIDED|97.5|-10.03|5.57|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||5.57|-10.03|
91764799|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764800|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91544368|NCT04982315|182967266|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.06|TWO_SIDED|95.0|0.0|0.5|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||0.5|0|.06
91544369|NCT04982315|182967268|SUPERIORITY||Mean Difference (Final Values)|-0.4||||-0.06|TWO_SIDED|95.0|-1.7|0.08|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.08|-1.7|-.06
91544370|NCT04982315|182967268|SUPERIORITY||Mean Difference (Final Values)|-1.0||||-0.15|TWO_SIDED|95.0|-2.4|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.3|-2.4|-.15
91544371|NCT04982315|182967268|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.387|TWO_SIDED|95.0|-1.9|0.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.7|-1.9|.387
91544372|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.967|TWO_SIDED|95.0|-0.02|0.02|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||.02|-.02|.967
91764801|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764802|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764803|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764804|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91544373|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.272|TWO_SIDED|95.0|-0.1|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.3|-.1|.272
91544374|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.049|TWO_SIDED|95.0|0.0|0.4|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||0.4|0|.049
91544375|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.409|TWO_SIDED|95.0|-0.1|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.3|-.1|.409
91544376|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.62|TWO_SIDED|95.0|-0.1|0.2|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.2|-.1|.62
91544377|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.121|TWO_SIDED|95.0|0.0|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.3|0|.121
91544378|NCT04982315|182967269|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.27|TWO_SIDED|95.0|-0.1|0.2|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.2|-.1|.27
91544379|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.069|TWO_SIDED|95.0|-0.4|0.02|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||.02|-.4|.069
91544380|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.013|TWO_SIDED|95.0|-0.6|-0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-.1|-.6|.013
91544381|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.043|TWO_SIDED|95.0|-0.5|-0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-.1|-.5|.043
91544382|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.629|TWO_SIDED|95.0|-0.2|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.3|-.2|.629
91544383|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.001|TWO_SIDED|95.0|-0.6|-0.2|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-.2|-.6|.001
91544384|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.019|TWO_SIDED|95.0|-0.5|-0.05|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-.05|-.5|.019
91764805|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764806|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
91764807|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764808|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
91764809|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
91764810|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764811|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91764812|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764813|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764814|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764815|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764816|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764817|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764818|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
91544385|NCT04982315|182967270|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.271|TWO_SIDED|95.0|-0.1|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.3|-.1|.271
91544386|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.191|TWO_SIDED|95.0|-0.3|0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||.1|-.3|.191
91544387|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.038|TWO_SIDED|95.0|-0.5|-0.01|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-.01|-.5|.038
91544388|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.019|TWO_SIDED|95.0|-0.5|-0.05|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||-.05|-.5|.019
91544389|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.803|TWO_SIDED|95.0|-0.2|0.2|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.2|-.2|.803
91513983|NCT00489970|182899991|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|4.01|||||TWO_SIDED|97.5|-2.38|8.66|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||8.66|-2.38|
91764819|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
91764820|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764821|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764822|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764823|NCT01128426|183418963|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91764824|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .63
91764825|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91764826|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764827|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.6|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.60
91764828|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764829|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764830|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764831|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764832|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764833|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
91764834|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
91764835|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764836|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764837|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764838|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
91544390|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.163|TWO_SIDED|95.0|-0.4|0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.1|-.4|.163
91544391|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.625|TWO_SIDED|95.0|-0.2|0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.1|-.2|.625
91544392|NCT04982315|182967271|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.198|TWO_SIDED|95.0|-0.1|0.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.3|-.1|.198
91544393|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.194|TWO_SIDED|95.0|-2.1|0.4|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||.4|-2.1|.194
91544394|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.51|TWO_SIDED|95.0|-2.0|1.0|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1|-2|.51
91544395|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.218|TWO_SIDED|95.0|-2.5|0.6|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||.6|-2.5|.218
91544396|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.62|TWO_SIDED|95.0|-2.3|1.4|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1.4|-2.3|.62
91544397|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.07|TWO_SIDED|95.0|-2.7|0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.1|-2.7|.07
91544398|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0|TWO_SIDED|95.0|-3.6|-1.0|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||-1|-3.6|0
91764839|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91764840|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
91764841|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764842|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764843|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
91764844|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
91764845|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764846|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764847|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764848|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764849|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
91764850|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
91764851|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764852|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764853|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764854|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
91764855|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
91764856|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
91544399|NCT04982315|182967272|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.086|TWO_SIDED|95.0|-2.2|0.1|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.1|-2.2|.086
91544400|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.023|TWO_SIDED|95.0|0.2|2.3|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.||2.3|.2|.023
91544401|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.186|TWO_SIDED|95.0|-0.4|2.0|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||2|-.4|.186
91544402|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.107|TWO_SIDED|95.0|-0.2|2.5|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||2.5|-.2|.107
91544403|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.651|TWO_SIDED|95.0|-1.0|1.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 6 months||1.7|-1|.651
91544404|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.001|TWO_SIDED|95.0|0.7|2.9|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||2.9|.7|.001
91544405|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.007|TWO_SIDED|95.0|0.4|2.7|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||2.7|.4|.007
91544406|NCT04982315|182967273|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.656|TWO_SIDED|95.0|-1.2|0.8|||Wald Test, 2-sided|Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model.||Difference in change from baseline at 12 months||.8|-1.2|.656
91544407|NCT04929483|182967299|SUPERIORITY||Treatment Difference|34.65|||<|0.0001|TWO_SIDED|95.0|10.04|59.26|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with missing outcome measures handled by multiple imputation method.||||59.26|10.04|<0.0001
91544408|NCT04929483|182967299|SUPERIORITY||Treatment Difference|20.89||||0.0009|TWO_SIDED|95.0|9.05|32.72|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with missing outcome measures handled by multiple imputation method.||||32.72|9.05|0.0009
91544409|NCT04929483|182967299|SUPERIORITY||Treatment Difference|23.61||||0.0005|TWO_SIDED|95.0|10.04|37.18|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with missing outcome measures handled by multiple imputation method.||||37.18|10.04|0.0005
91544410|NCT04929483|182967300|SUPERIORITY||Treatment Difference|14.45||||0.1039|TWO_SIDED|95.0|-8.71|37.62|||Cochran-Mantel-Haenszel|||||37.62|-8.71|0.1039
91544411|NCT04929483|182967300|SUPERIORITY||Treatment Difference|18.87||||0.0085|TWO_SIDED|95.0|5.24|32.5|||Cochran-Mantel-Haenszel|||||32.50|5.24|0.0085
91544412|NCT04929483|182967300|SUPERIORITY||Treatment Difference|20.33||||0.0077|TWO_SIDED|95.0|5.26|35.4|||Cochran-Mantel-Haenszel|||||35.40|5.26|0.0077
91544413|NCT04083781|182967330|SUPERIORITY|Analyses of count endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as an offset with randomised treatment regimen, type of haemophilia (HAwI or HBwI) and bleeding frequency (less than 9 or greater than or equal to 9 bleeding episodes during the past 24 weeks prior to screening) as factors comparing arm 1 (on-demand treatment) and arm 2.|Annualised bleeding rate ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.07|0.29|||Two-sided test of no difference from 1|||||0.29|0.07|<0.001
91544414|NCT01061671|182967357|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||negative binomial regression|Adjustments of confidence intervals for between-participant variation (overdispersion).||||||0.54
91544415|NCT01061671|182967358|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Log Rank|||||||0.34
91544416|NCT01061671|182967359|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED||||||t-test, 2 sided|||||||.1461
91544417|NCT02468128|182967365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.2|||<|0.01|TWO_SIDED|95.0|-71.68|-12.71|||ANOVA|||||-12.71|-71.68|<0.01
91544418|NCT02468128|182967366|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
91544419|NCT02468128|182967367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
91544420|NCT02468128|182967368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Log-rank tests|Log-rank tests were used to compare SDE and placebo with respect to the distribution of time to first post-surgical usage of ketorolac medication.||||||<0.05
91544421|NCT02468128|182967369|SUPERIORITY|ANOVA with Treatment, Center effect (and Treatment\*Center effect if p-value ≤ 0.1 in non-reduced model)|||||<|0.05||||||ANOVA with Treatment, Center effect (and Treatment\*Center effect if p-value ≤ 0.1 in non-reduced model)|ANOVA|ANOVA with Treatment, Center effect (and Treatment\*Center effect if p-value ≤ 0.1 in non-reduced model)||ANOVA with Treatment, Center effect (and Treatment\*Center effect if p-value ≤ 0.1 in non-reduced model)||||<0.05
91544422|NCT02468128|182967370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
91544423|NCT02468128|182967371|SUPERIORITY_OR_OTHER_LEGACY|At the final visit, each subject was asked the questions for evaluation of satisfaction and a Cochran-Mantel-Haenszel test was used in comparison of subjects' satisfaction with post-surgical analgesic between treatment groups.|||||>|0.05||||||Satisfaction was evaluated using a patient-reported rating scale to assess the subject's overall satisfaction with postoperative analgesia. More participants indicate greater satisfaction with that treatment.|Cochran-Mantel-Haenszel|||At the final visit, each subject was asked the questions for evaluation of satisfaction and a Cochran-Mantel-Haenszel test was used in comparison of subjects' satisfaction with post-surgical analgesic between treatment groups.||||>0.05
91544424|NCT02468128|182967372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-115.2|||<|0.05|TWO_SIDED|95.0|-209.153|-21.26|||ANOVA|||||-21.26|-209.153|<0.05
91544425|NCT01503749|182967374|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
91544426|NCT00440011|182967375|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.024
91544427|NCT01172418|182967378|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
91544428|NCT01172418|182967379|SUPERIORITY|||||||0.37|||||||Log Rank|||||||0.37
91544429|NCT01172418|182967380|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
91544430|NCT01172418|182967381|SUPERIORITY|||||||0.25|||||||Log Rank|||||||0.25
91544431|NCT02998528|182967388|SUPERIORITY||Cox Proportional Hazard|0.63||||0.0052|TWO_SIDED|97.38|0.43|0.91|||Log Rank|Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)||||0.91|0.43|0.0052
91544432|NCT02998528|182967389|SUPERIORITY||% Difference|21.6|||||TWO_SIDED|99.0|13.0|30.3|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||30.3|13.0|
91544433|NCT02998528|182967389|SUPERIORITY||Odds Ratio (OR)|13.94|||<|0.0001|TWO_SIDED|99.0|3.49|55.75|||Cochran-Mantel-Haenszel||Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||55.75|3.49|<0.0001
91544434|NCT02998528|182967390|SUPERIORITY||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.51|0.91||||Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)||||0.91|0.51|
91544435|NCT02998528|182967391|SUPERIORITY||% Difference|27.9|||||TWO_SIDED|95.0|19.6|36.1|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||36.1|19.6|
91544436|NCT02998528|182967391|SUPERIORITY||Odds Ratio (OR)|5.7|||||TWO_SIDED|95.0|3.16|10.26|||||Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||10.26|3.16|
91544437|NCT02998528|182967393|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.9|||||Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||0.90|0.49|
91544438|NCT03671811|182967440|SUPERIORITY|The planned sample size was 36 evaluable participants, with 18 per treatment arm. Based on a one-sided t-test at α = 0.05, the study was designed to provide 90% power to detect a difference of at least 10 percentage points in the mean reduction of Ki-67 between arms, assuming a standard deviation of 10%. The difference was expected to favor the Pterostilbene + Megestrol Acetate arm.||||||0.9|||||||t-test, 1 sided|||||||0.9
91544439|NCT03671811|182967445|SUPERIORITY|This was a one-sided t-test at α = 0.05. The difference was expected to favor the Pterostilbene + Megestrol Acetate arm.||||||0.6|||||||t-test, 1 sided|||||||0.6
91544440|NCT03671811|182967446|SUPERIORITY|This was a one-sided t-test at α = 0.05. The difference was expected to favor the Pterostilbene + Megestrol Acetate arm.||||||0.2|||||||t-test, 1 sided|||||||0.2
91544441|NCT03494504|182967448|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|95.0|1.46|3.84||||||||3.84|1.46|
91544442|NCT03494504|182967448|SUPERIORITY||Odds Ratio (OR)|1.81|||||TWO_SIDED|95.0|1.11|2.94||||||||2.94|1.11|
91544443|NCT04500301|182967495|OTHER|No statistical test was performed.|Proportion|0.136|||||TWO_SIDED|95.0|0.054|0.219|||||The Wald 95% confidence interval for the binomial proportion was estimated.|No hypothesis was tested with regard to the primary outcome. The study planned to enroll 80 eligible subjects such that at least 65 would be evaluable for the primary outcome and the width of the 95% Clopper-Pearson confidence interval for the proportion would be less than or equal to .25.||0.219|0.054|
91544444|NCT01443845|182967508|SUPERIORITY_OR_OTHER||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.063||0.1634|TWO_SIDED|95.0|0.81|1.04|||negative binomial regression||p-values are based on a negative binomial regression with factors Treatment and LAMA use.|Rate ratio (Roflumilast/Placebo). A rate ratio \< 1 represents a favorable outcome for the test treatment.||1.04|0.81|0.1634
91544445|NCT01443845|182967508|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.08||0.0195|TWO_SIDED|95.0|0.71|0.97|||negative binomial regression|||Subgroup Analysis - By Sex - Male||0.97|0.71|0.0195
91544446|NCT01443845|182967508|SUPERIORITY_OR_OTHER||Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.101||0.3164|TWO_SIDED|95.0|0.91|1.35|||negative binomial regression|||Subgroup Analysis - By Sex - Female||1.35|0.91|0.3164
91544447|NCT01443845|182967508|SUPERIORITY_OR_OTHER||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.076||0.0385|TWO_SIDED|95.0|0.74|0.99|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||0.99|0.74|0.0385
91544448|NCT01443845|182967508|SUPERIORITY_OR_OTHER||Rate Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.114||0.6475|TWO_SIDED|95.0|0.84|1.32|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||1.32|0.84|0.6475
91544449|NCT01443845|182967509|SUPERIORITY_OR_OTHER||Rate Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.118||0.6354|TWO_SIDED|95.0|0.75|1.19|||negative binomial regression|||||1.19|0.75|0.6354
91544450|NCT01443845|182967510|SUPERIORITY_OR_OTHER||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.0884|TWO_SIDED|95.0|0.8|1.02|||negative binomial regression|||||1.02|0.8|0.0884
91544451|NCT01443845|182967511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0532|STANDARD_ERROR_OF_MEAN|0.0067|<|0.0001|TWO_SIDED|95.0|0.04|0.0664||The MMRM analysis is based on all postbaseline observed data using a mixed model with terms for treatment, baseline, visit, LAMA use, treatment-by-visit and baseline-by-visit interactions.|Mixed Model for Repeated Measures (MMRM)|||||0.0664|0.04|< 0.0001
91544452|NCT01808339|182967518|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.077|||||TWO_SIDED|90.0|0.001|0.152|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and Placebo (FF 100 µg AM minus Placebo).|||0.152|0.001|
91544453|NCT01808339|182967518|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.105|||||TWO_SIDED|90.0|0.029|0.18|||||The estimated value represents the difference in Least Squares Means between FF 100 µg PM and Placebo (FF 100 µg PM minus Placebo).|||0.180|0.029|
91544454|NCT01808339|182967518|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.028|||||TWO_SIDED|90.0|-0.102|0.045|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and FF 100 µg PM (FF 100 µg AM minus FF 100 µg PM).|||0.045|-0.102|
91544455|NCT02088853|182967557|SUPERIORITY|Wilcoxon test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91544456|NCT02088853|182967558|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91544457|NCT02088853|182967559|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91544458|NCT03351699|182967560|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.53|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 78%.|||||
91544459|NCT03351699|182967560|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.73|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 95%.|||||
91764857|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764858|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91764859|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764860|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91544460|NCT03351699|182967560|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.52|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 75%.|||||
91544461|NCT03351699|182967560|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.75|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 96%.|||||
91544462|NCT00957242|182967585|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.27|TWO_SIDED|95.0|0.7|2.47|||Regression, Cox|Prespecified covariates in the model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.|Warfarin vs. Placebo|The study was designed to have 90% power to detect a difference in 48-week event free rates of 70% for the warfarin group versus 50% for the placebo group. A total of at least 95 adjudicated primary endpoints were required to achieve 90% power with 2-sided, type I error rate of 0.05 and a 1:1 randomization ratio. These calculations yielded a requisite total sample size of 256.||2.47|0.70|0.27
91544463|NCT00957242|182967586|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|5.03||||0.005|TWO_SIDED|95.0|1.44|17.54|||Cox Proportional|||||17.54|1.44|0.005
91544464|NCT00957242|182967587|SUPERIORITY_OR_OTHER||t-value|0.08||||0.083||95.0|-0.01|0.17|||Mixed Models Analysis|||||0.17|-0.01|0.083
91544465|NCT00957242|182967588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.054|TWO_SIDED|95.0|0.99|4.31|||Cox Proportional|||||4.31|0.99|0.054
91544466|NCT00957242|182967589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.47||||0.19|TWO_SIDED|95.0|0.64|9.56|||Cox Proportional|||||9.56|0.64|0.19
91544467|NCT00957242|182967590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.25||||0.35|TWO_SIDED|95.0|0.41|12.34|||Cox Proportional|||||12.34|0.41|0.35
91544468|NCT00957242|182967591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.24||||0.15|TWO_SIDED|95.0|0.65|16.1|||Cox Proportional|||||16.10|0.65|0.15
91544469|NCT00957242|182967592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.88|TWO_SIDED|95.0|0.24|3.39|||Cox Proportional|||||3.39|0.24|0.88
91544470|NCT00957242|182967593|SUPERIORITY_OR_OTHER||t-value|10.88||||0.7222|TWO_SIDED|95.0|-49.57|71.34|||Mixed Models Analysis|||||71.34|-49.57|0.7222
91544471|NCT00957242|182967594|SUPERIORITY_OR_OTHER||t-value|-1.78||||0.27|TWO_SIDED|95.0|-7.04|3048.0|||Mixed Models Analysis|||||3048|-7.04|0.27
91544472|NCT00957242|182967595|SUPERIORITY_OR_OTHER||t-value|0.05||||0.957|TWO_SIDED|95.0|-1.67|1076.0|||Mixed Models Analysis|||||1076|-1.67|0.957
91544473|NCT00957242|182967596|SUPERIORITY_OR_OTHER||t-value|-0.48||||0.009|TWO_SIDED|95.0|-0.84|-0.12|||Mixed Models Analysis|||||-0.12|-0.84|0.009
91544474|NCT01381406|182967598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.772||||0.007|TWO_SIDED|95.0|0.641|0.93||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Any COPD Exacerbation|Regression, Logistic|||||0.930|0.641|0.007
91544475|NCT01381406|182967598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.622||||0.146|TWO_SIDED|95.0|0.328|1.18||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Severe COPD Exacerbations|Regression, Logistic|||||1.180|0.328|0.146
91544476|NCT01381406|182967598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.013|TWO_SIDED|95.0|0.646|0.949||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Moderate COPD Exacerbations|Regression, Logistic|||||0.949|0.646|0.013
91544477|NCT00567489|182967614|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
91544478|NCT00567489|182967614|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
91544479|NCT00567489|182967615|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
91544480|NCT00567489|182967615|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
91544481|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
91544482|NCT00567489|182967617|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
91544483|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
91544484|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
91544485|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
91544486|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
91544487|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
91544488|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
91544489|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
91544490|NCT00567489|182967617|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
91544491|NCT00567489|182967618|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
91544492|NCT00567489|182967618|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
91544493|NCT00567489|182967618|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
91544494|NCT00567489|182967618|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
91544495|NCT00567489|182967618|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
91764861|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91544496|NCT00567489|182967618|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
91544497|NCT00567489|182967619|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
91544498|NCT00567489|182967619|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
91544499|NCT00567489|182967619|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
91544500|NCT00567489|182967619|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
91544501|NCT00567489|182967620|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
91544502|NCT00567489|182967620|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
91544503|NCT00567489|182967621|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
91544504|NCT00567489|182967622|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
91544505|NCT00567489|182967622|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
91544506|NCT00567489|182967622|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
91544507|NCT00567489|182967622|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
91544508|NCT00567489|182967623|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
91544509|NCT00567489|182967623|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
91544510|NCT00567489|182967623|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
91544511|NCT00567489|182967623|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
91544512|NCT00567489|182967624|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
91544513|NCT00567489|182967624|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
91544514|NCT00567489|182967625|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
91544515|NCT00567489|182967625|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
91544516|NCT00567489|182967626|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
91544517|NCT00567489|182967626|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
91544518|NCT00567489|182967627|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
91544519|NCT00567489|182967628|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
91764862|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91544520|NCT00567489|182967628|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
91544521|NCT00567489|182967628|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
91544522|NCT00567489|182967628|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
91544523|NCT00567489|182967629|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
91544524|NCT00567489|182967629|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
91544525|NCT00567489|182967630|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
91544526|NCT00567489|182967630|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
91544527|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
91544528|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
91544529|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
91544530|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
91544531|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
91544532|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
91544533|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
91544534|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
91544535|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
91544536|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
91544537|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
91544538|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
91544539|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
91544540|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
91544541|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
91544542|NCT00567489|182967631|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
91544543|NCT00567489|182967632|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
91544544|NCT00567489|182967632|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
91544545|NCT00567489|182967633|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
91544546|NCT00567489|182967633|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
91544547|NCT00567489|182967634|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
91544548|NCT00567489|182967634|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
91544549|NCT00567489|182967635|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
91764863|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91544550|NCT02570022|182967636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||t-test, 2 sided||This analysis corresponds to the visual analog scale and morphine equivalent data.|Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtained||||<0.05
91544551|NCT00262730|182967642|NON_INFERIORITY_OR_EQUIVALENCE|study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.|Hazard Ratio (HR)|0.8|STANDARD_DEVIATION|0.025|>|0.1|TWO_SIDED|95.0|0.8|0.85|||Log Rank|||||0.85|0.8|>.1
91544552|NCT00419341|182967644|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of SCIG:IVIG treatment was concluded if the lower GMR confidence limit was 0.8 or more. With 18 evaluable subjects, the power to show this non-inferiority was calculated to be 85% based on the assumptions of an intra-individual variability with a coefficient of variation (CV) = 25% and a GMR equal to or greater than 1.|Geometric mean ratio (GMR)|1.002|||||TWO_SIDED|90.0|0.951|1.055||No P-value is provided as non-inferiority was assessed by the CI of the GMR.|t-test, 2 sided|Based on log-transformed individual differences.|Geometric mean ratio SCIG:IVIG non-inferiority was concluded if the lower GMR confidence limit was 0.8 or more|Individual sAUC values (standardized to a 7-day period) of the IV and adjusted SC sampling periods in each individual subject were log transformed and a parametric 2-sided 90% confidence interval (CI) for the mean of the individual differences was obtained. Back-transformation of the mean and its CI produced the geometric mean ratio (GMR) and its respective 90% CI.||1.055|0.951|
91544553|NCT02692417|182967670|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
91544554|NCT02692417|182967670|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.225
91544555|NCT02692417|182967671|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
91544556|NCT02692417|182967671|OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.046
91544557|NCT02692417|182967672|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
91544558|NCT02692417|182967672|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91764864|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764865|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91764866|NCT01128426|183418964|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91764867|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764868|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
91764869|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91544559|NCT02020252|182967673|SUPERIORITY|||||||0.307||||||This is for the receptivity sub-scale, and the comparison between pre and post-test scores.|t-test, 2 sided|This was a paired t-test.||||||.307
91544560|NCT02020252|182967673|SUPERIORITY|||||||0.009||||||This is for the willingness sub-scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.009
91764870|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
91764871|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764872|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
91764873|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764874|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764875|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764876|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
91764877|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
91764878|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
91764879|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764880|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91544561|NCT02020252|182967673|SUPERIORITY||||||<|0.001||||||This is for knowledge sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|A paired t-test.||||||<.001
91544562|NCT02020252|182967673|SUPERIORITY|||||||0.004||||||This is for the positive attitudes sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.004
91544563|NCT02020252|182967673|SUPERIORITY||||||<|0.001||||||This was for the self-efficacy sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||<.001
91544564|NCT04690556|182967743|EQUIVALENCE|Therapeutic equivalence was assessed based on the two-sided 90% Confidence Interval (CI) of the difference in least squares mean changes in BCVA from baseline at month 12 between LUBT010 and Lucentis for the pre-defined equivalence margin of (-4 letters, 4 letters).|Least squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.945|||TWO_SIDED|90.0|-1.52|1.58|||||Therapeutic equivalence met|LUBT010 (Proposed Ranibizumab Biosimilar) - Lucentis||1.58|-1.52|
91544565|NCT04310735|182967855|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the ventromedial prefrontal cortex region of interest.||||||0.13||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||0.13
91764881|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764882|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
91764883|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764884|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91764885|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764886|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764887|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764888|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91764889|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91764890|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764891|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
91764892|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764893|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764894|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764895|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
91764896|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764897|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
91764898|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
91764899|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764900|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
91764901|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764902|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764903|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764904|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764905|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
91544566|NCT04310735|182967855|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the dorsal anterior cingulate cortex region of interest.||||||0.25||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.25
91764906|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
91764907|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
91764908|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764909|NCT01128426|183418965|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764910|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764911|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
91764912|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.||||0.13
91764913|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91764914|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91764915|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
91764916|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764917|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764918|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764919|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764920|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
91764921|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764922|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764923|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764924|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764925|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
91764926|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764927|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91764928|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
91764929|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91764930|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
91764931|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91764932|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
91764933|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91764934|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
91764935|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91544567|NCT04310735|182967856|OTHER|Independent-samples t-tests were conducted to compare mean valence values during smoking-related cues between the Expect-Yes and Expect-No groups.||||||0.8|||||||t-test, 2 sided|Statistical significance was defined a priori as p\<0.05.||The null hypothesis was that there is no difference in the population means of the two groups.||||.80
91764936|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764937|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764938|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
91764939|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
91764940|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91544568|NCT04310735|182967856|OTHER|Independent-samples t-tests were conducted to compare mean valence values during neutral cues between the Expect-Yes and Expect-No groups.||||||0.87||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.87
91544569|NCT03012841|182967864|SUPERIORITY|The formal alternative hypothesis test for the primary effectiveness objective was that the Kaplan-Meier estimator of treatment success at 12 months (365 days) was greater than 40%, against the null hypothesis that it was less than or equal to 40%.|Kaplan-Meier (product-limit) estimator|54.8|||<|0.001|TWO_SIDED|95.0|46.7|62.1|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||62.1|46.7|<0.001
91764941|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764942|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
91764943|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
91764944|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
91764945|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
91764946|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
91764947|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
91764948|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
91764949|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91764950|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91544570|NCT03012841|182967865|SUPERIORITY|The formal alternative hypothesis tested for the primary safety objective was that the Kaplan-Meier estimator of the proportion of subjects with primary safety events at 12 months (365 days) was less than 13%, against the null hypothesis that it was greater than or equal to 13%.|Kaplan-Meier (product-limit) estimator|0.6||||0.002|TWO_SIDED|95.0|0.1|4.4|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.4|0.1|0.002
91544571|NCT03012841|182967866|SUPERIORITY||Mean Difference (Net)|25.8|||<|0.001|TWO_SIDED|95.0|22.1|29.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in AFEQT composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||29.5|22.1|<0.001
91544572|NCT03012841|182967867|SUPERIORITY||Mean Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|3.5|6.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 physical composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.5|3.5|<0.001
91544573|NCT03012841|182967868|SUPERIORITY||Mean Difference (Net)|4.9|||<|0.001|TWO_SIDED|95.0|3.2|6.6||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 mental composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.6|3.2|<0.001
91544574|NCT03398200|182967878|SUPERIORITY|||||||0.89|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.89
91544575|NCT03398200|182967879|SUPERIORITY|||||||0.03|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.03
91544576|NCT03398200|182967880|SUPERIORITY|||||||0.35|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.35
91544577|NCT03398200|182967881|SUPERIORITY|||||||0.77|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.77
91764951|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91544578|NCT03398200|182967882|SUPERIORITY|||||||0.5|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.50
91544579|NCT03398200|182967883|SUPERIORITY|||||||0.76|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.76
91544580|NCT04065048|182967884|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
91544581|NCT04065048|182967885|OTHER|||||||0.0093|||||||ANOVA|||||||0.0093
91544582|NCT04065048|182967887|OTHER|||||||0.2487|||||||Fisher Exact|||||||0.2487
91544583|NCT03397108|182967888|SUPERIORITY|||||||0.89||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk TNF levels at EARLY LACTATION PERIOD were compared between non-IBD control and women with IBD. Our hypothesis was that women with IBD have higher TNF in milk due to the underlying inflammatory condition (IBD).||||0.89
91764952|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91544584|NCT03397108|182967888|SUPERIORITY|||||||0.024|||||||Kruskal-Wallis|||"Milk TNF at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.024
91544585|NCT03397108|182967888|SUPERIORITY|||||||0.7||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 levels (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.70
91544586|NCT03397108|182967888|SUPERIORITY|||||||0.93||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk levels of MIP-1 beta (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.93
91544587|NCT03397108|182967888|SUPERIORITY|||||||0.12||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 levels (one of the TNF dependent chemokines) at EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.12
91544588|NCT03397108|182967888|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||Milk levels of TNF-dependent chemokine, MCP1, at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control and the 2 IBD subgroups. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MCP1. Nonparametric comparison of the 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test.||||0.12
91544589|NCT03397108|182967888|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||"Milk MIP-1beta at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MIP-1beta. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.051
91764953|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
91764954|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91544590|NCT03397108|182967888|SUPERIORITY|||||||0.0046|||||||Kruskal-Wallis|||"Milk IP10 at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including IP10. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.0046
91544591|NCT03397108|182967888|SUPERIORITY|||||||0.35||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Comparison of milk TNF level at the MID LACTATION POINT between non-IBD control and IBD group. The same analytical framework as the early lactation, but this is based on data at the mid-lactation point (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.35
91764955|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91764956|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
91764957|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
91764958|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
91764959|NCT01128426|183418966|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764960|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764961|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91764962|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91764963|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91544592|NCT03397108|182967888|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||"Milk TNF at MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. Hypothesis is the same as for the early lactation point. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.11
91544593|NCT03397108|182967888|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 level comparison between non-IBD control and IBD group at the MID LACTATION POINT(13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.26
91544594|NCT03397108|182967888|SUPERIORITY|||||||0.15||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MIP-1beta level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.15
91544595|NCT03397108|182967888|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.31
91544596|NCT03397108|182967888|SUPERIORITY|||||||0.21|||||||Kruskal-Wallis|||"Milk MCP-1 at the MID LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.21
91544597|NCT03397108|182967888|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||"Milk MIP-1beta at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.12
91544598|NCT03397108|182967888|SUPERIORITY|||||||0.29|||||||Kruskal-Wallis|||"Milk IP10 at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The same hypothesis as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.29
91544599|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.7232|||<|0.0001|TWO_SIDED|95.0|0.5647|0.8303||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MCP1 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MCP1.||0.8303|0.5647|<0.0001
91544600|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.6835|||<|0.0001|TWO_SIDED|95.0|0.5088|0.8042||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MIP-1beta to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MIP-1beta.||0.8042|0.5088|<0.0001
91544601|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.6316|||<|0.0001|TWO_SIDED|95.0|0.4377|0.7693||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine IP10 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine IP10.||0.7693|0.4377|<0.0001
91544602|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.572|||<|0.0001|TWO_SIDED|95.0|0.3445|0.736||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MCP1 to see of they are positively correlated.||0.7360|0.3445|<0.0001
91544603|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.7564|||<|0.0001|TWO_SIDED|95.0|0.6022|0.8562||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MIP-1beta to see of they are positively correlated.||0.8562|0.6022|<0.0001
91544604|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.32||||0.0227|TWO_SIDED|95.0|0.03869|0.552||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and IP10 to see of they are positively correlated.||0.5520|0.03869|0.0227
91544605|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.52||||0.0001|TWO_SIDED|95.0|0.2727|0.6975||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk TNF between early and mid-lactation points.||0.6975|0.2727|0.0001
91764964|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
91764965|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91544606|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.4722||||0.0005|TWO_SIDED|95.0|0.2181|0.6664||Not adjusted for multiple comparison.|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MCP1 between early and mid-lactation points.||0.6664|0.2181|0.0005
91764966|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
91764967|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
91764968|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91764969|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
91544607|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.36||||0.01|TWO_SIDED|95.0|0.0802|0.5803||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MIP-1beta between early and mid-lactation points.||0.5803|0.0802|0.01
91544608|NCT03397108|182967888|OTHER|Correlation analysis|Spearman rank correlation|0.66|||<|0.0001|TWO_SIDED|95.0|0.467|0.7964||Not adjusted for multiple comparison|Spearman rank correlation|Spearman r = 0.66 (95%CI: 0.4670 - 0.7964). Number of XY pairs: 51||Using the pooled data of all participants, we assessed temporal tracking of milk IP10 between early and mid-lactation points.||0.7964|0.4670|<0.0001
91544609|NCT03397108|182967889|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Cognitive development at 12 months of age. Animal data suggested that pups receiving milk with lower TNF and TNF-dependent chemokines showed enhanced cognitive development. Because there was no guiding information in humans regarding milk TNF level differences between women with and without IBD, our main goal was to measure milk TNF levels. The infant cognitive/language assessment, therefore, had to be designed as a pilot and exploratory in nature.||||0.12
91764970|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
91764971|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91764972|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764973|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91764974|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
91764975|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
91764976|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
91764977|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
91544610|NCT03397108|182967889|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Language development at 12 months of age.||||0.56
91544611|NCT03397108|182967889|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Cognitive development at 18 months of age.||||0.16
91544612|NCT03397108|182967889|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Language development at 18 months of age||||0.75
91764978|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
91764979|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91764980|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764981|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
91764982|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
91764983|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
91764984|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91764985|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91764986|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
91764987|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
91764988|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
91764989|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764990|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91764991|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91764992|NCT01128426|183418967|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91764993|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
91764994|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91764995|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method]|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
91764996|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
91764997|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91764998|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91764999|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
91765000|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91765001|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91765002|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91765003|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91765004|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91765005|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91765006|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91765007|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91765008|NCT01128426|183418967|SUPERIORITY_OR_OTHER|||||||0.94|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.94
91765009|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
91765010|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
91765011|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91765012|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91765013|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91765014|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
91765015|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91765016|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
91765017|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91765018|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
91765019|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91544613|NCT03397108|182967889|OTHER|Correlation analysis|Spearman rank correlation|0.2655||||0.0853|TWO_SIDED|95.0|-0.047|0.5307|||Spearman rank correlation|||Using pooled data of all participants at the early-lactation sample point, correlation between milk TNF levels and 12 month cognitive development was examined to investigate if they were inversely correlated.||0.5307|-0.047|0.0853
91765020|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
91765021|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
91765022|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
91765023|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
91765024|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
91765025|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
91765026|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
91765027|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
91765028|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91765029|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91765030|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91765031|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91765032|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
91765033|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
91765034|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
91765035|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91765036|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
91765037|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91765038|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91765039|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
91765040|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
91765041|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
91765042|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
91765043|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91765044|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91765045|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
91765046|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91765047|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
91765048|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
91765049|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
91765050|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.72|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.72
91765051|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91765052|NCT01128426|183418968|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91765053|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91765054|NCT01128426|183418968|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
91765055|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91765056|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91765057|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
91765058|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91765059|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
91765060|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
91765061|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91765062|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
91765063|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
91765064|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91765065|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
91765066|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
91765067|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
91765068|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
91765069|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
91765070|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
91765071|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
91765072|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
91765073|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
91765074|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
91765075|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
91765076|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
91765077|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
91765078|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
91765079|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91544614|NCT03397108|182967889|OTHER|Correlation analysis|Spearman rank correlation|0.3705||||0.09|TWO_SIDED|95.0|-0.07385|0.6921|||Spearman rank correlation|||Using the pooled data of all participants, correlation analysis between milk TNF at early lactation and 12 month language score was done to see if they were inversely correlated.||0.6921|-0.07385|0.090
91544615|NCT03397108|182967891|SUPERIORITY|||||||0.97||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that the 2 groups are not different for their sampling time points in the early lactation period.||||0.97
91544616|NCT03397108|182967891|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||0.96
91544617|NCT03397108|182967892|SUPERIORITY|||||||0.56||||||No adjustment for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that there is no difference in the second sampling time points in the mid-lactation period between the groups.||||0.56
91544618|NCT03397108|182967892|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
91544619|NCT04337372|182967928|SUPERIORITY||||||=|0.002||||||F(2, 58) = 7.19|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of age is reported here.||||=.002
91544620|NCT04337372|182967928|SUPERIORITY||||||=|0.09||||||F(1.78, 103.37) = 2.48|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of condition is reported here.||||=.09
91544621|NCT04337372|182967928|SUPERIORITY||||||<|0.05||||||F(3.56, 103.37) = 2.55|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The interaction between age and condition is reported here.||||<.05
91765080|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
91765081|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
91765082|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91765083|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
91765084|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
91765085|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
91765086|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91765087|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
91765088|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
91765089|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91765090|NCT01128426|183418969|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91765091|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
91765092|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
91765093|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
91765094|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
91765095|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91765096|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
91765097|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
91765098|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91765099|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
91765100|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91765101|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
91765102|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
91765103|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
91765104|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
91765105|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
91765106|NCT01128426|183418969|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
91765107|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
91765108|NCT01128426|183418969|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
91765109|NCT05729568|183418989|SUPERIORITY||Difference in least-squares means|-56.0||||0.1436|TWO_SIDED|95.0|-132.0|20.0|||ANCOVA||Difference in least-squares means (Diff in LSM), and its 95% CI were from ANCOVA model of change from baseline CD4 cell count with treatment as fixed effect and baseline CD4 cell count as a covariate.|||20|-132|0.1436
91765110|NCT00550953|183419002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|6.41|9.63|||ANCOVA||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy|||9.63|6.41|<0.0001
91765111|NCT00632619|183419012|SUPERIORITY_OR_OTHER|||||||0.106|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.106
91544622|NCT04337372|182967929|SUPERIORITY||||||=|0.557||||||F(2,47) = .592|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of age is reported here.||||=.557
91765112|NCT00632619|183419013|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline which was week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.015
91544623|NCT04337372|182967929|SUPERIORITY||||||=|0.47||||||F(2,47) = .767|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of condition is reported here.||||=.470
91765113|NCT00632619|183419014|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was conducted to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.38
91765114|NCT00632619|183419015|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.016
91765115|NCT00632619|183419016|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.095
91765116|NCT00428948|183419026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.708|||<|0.0001|TWO_SIDED|95.0|-3.269|-2.147|||Linear mixed model||The variance of the random effect intercept was zero and resulted in a non-positive, definite variance-covariance matrix for the random effects.|The null hypothesis was that there was no difference in the percentage change per year in total kidney volume between the tolvaptan group and the placebo group.||-2.147|-3.269|<0.0001
91765117|NCT00428948|183419027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.865||||0.0095|TWO_SIDED|95.0|0.775|0.965|||Recurrent event analysis||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the ADPKD clinical progression events/100 follow-up years between the tolvaptan group and the placebo group.||0.965|0.775|0.0095
91765118|NCT00428948|183419028|SUPERIORITY_OR_OTHER||Difference in slope|0.977|||<|0.0001|TWO_SIDED|95.0|0.597|1.357|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.||The null hypothesis was that there was no difference in the change in renal function per year between the tolvaptan group and the placebo group.||1.357|0.597|<0.0001
91765119|NCT00428948|183419029|SUPERIORITY_OR_OTHER||Difference in slope|-0.246||||0.552|TWO_SIDED|95.0|-1.059|0.566|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.|Placebo minus tolvaptan.|The null hypothesis was that there was no difference in mean arterial blood pressure in non-hypertensive participants between the tolvaptan group and the placebo group.||0.566|-1.059|0.5520
91544624|NCT04337372|182967929|SUPERIORITY||||||=|0.046||||||F(4,94) = 2.524|MANOVA|||EEG power, as measured by signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each condition. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The interaction of age and condition is reported here.||||=.046
91544625|NCT04337372|182967930|SUPERIORITY||||||=|0.664||||||F(2,45) = .413|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of age is reported here.||||=.664
91544626|NCT04337372|182967930|SUPERIORITY||||||=|0.768||||||F(2,45) = .266|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of condition is reported here.||||=.768
91544627|NCT04337372|182967930|SUPERIORITY||||||=|0.2||||||F(4,90) = 1.531|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The interaction of age and condition is reported.||||=.200
91544628|NCT04337372|182967931|SUPERIORITY||||||=|0.022||||||F(2, 57) = 4.11|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of age is reported here.||||=.022
91544629|NCT04337372|182967931|SUPERIORITY||||||=|0.004||||||F(2, 114) = 5.69|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of condition is reported here.||||=.004
91544630|NCT04337372|182967931|SUPERIORITY||||||=|0.168||||||F(4, 114) = 1.64|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The interaction of age and condition is reported here.||||=.168
91544631|NCT02488863|182967961|OTHER|ANOVA||||||0.0561|||||||ANOVA|||H0: mean(SPPB\_older\_pain) = mean(SPPB\_older\_no pain) = mean(SPPB\_younger)||||0.0561
91765120|NCT00428948|183419030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.1604|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|The analysis included baseline renal pain as a covariate.|Derived from ANCOVA with factors of treatment and baseline stratification factor interaction and covariate renal pain baseline.|The null hypothesis was that there was no difference in the change in renal pain between the tolvaptan group and the placebo group.||0.03|-0.20|0.1604
91765121|NCT00428948|183419031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9704|TWO_SIDED|95.0|0.805|1.233|||Recurrent event analysis||Derived from rate and mean model of time to recurrent event analysis with factor treatment.|The null hypothesis was that there was no difference in the hypertensive events per 100 follow-up years in non-hypertensive participants between the tolvaptan group and the placebo group.||1.233|0.805|0.9704
91765122|NCT00428948|183419032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.7532|TWO_SIDED|95.0|0.602|2.017|||Cochran-Mantel-Haenszel||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the percentage of participants with a clinically sustained decrease of blood pressure leading to a sustained reduction in antihypertensive therapy between the tolvaptan group and the placebo group.||2.017|0.602|0.7532
91765123|NCT03559933|183419037|SUPERIORITY||Logistic regression model|95.0|STANDARD_ERROR_OF_MEAN|0.0152||0.0125|TWO_SIDED|95.0|93.15|96.66|||Mixed Models Analysis|Subject and stimulation within subject as random effects with multiple observations per subject was accounted for.||The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects with multiple observations per subject. The null hypothesis was tested comparing the lower bound of the 98.75% two-sided confidence interval for the estimated percent diaphragm capture rate to the performance goal of 80%. If the lower bound was greater than 80%, the null hypothesis was rejected, and the endpoint was considered met.||96.66|93.15|0.0125
91765124|NCT02119663|183419042|OTHER||Hazard Ratio (HR)|1.584|||||TWO_SIDED|95.0|0.886|2.83||||||||2.830|0.886|
91544632|NCT01704079|182967962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91544633|NCT01704079|182967963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91544634|NCT01704079|182967964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91544635|NCT01704079|182967965|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91544636|NCT00520546|182968010|SUPERIORITY_OR_OTHER||sensitivity|97.0||||0.0526|TWO_SIDED|95.0|86.0|100.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|86|0.0526
91765125|NCT01099397|183419082|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value at baseline|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
91765126|NCT01099397|183419082|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value at 9 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.59
91544637|NCT00520546|182968010|SUPERIORITY_OR_OTHER||specificity|0.0||||0.0526|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|0.0526
91544638|NCT00520546|182968010|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0526|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0526
91765127|NCT01099397|183419082|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||P-value at 18 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
91765128|NCT02363959|183419083|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
91765129|NCT02363959|183419084|OTHER|||||||0.39|||||||Fisher Exact|||||||0.39
91765130|NCT02363959|183419085|OTHER|||||||1|||||||Fisher Exact|||||||1
91765131|NCT02363959|183419086|OTHER|||||||1|||||||Fisher Exact|||||||1
91765132|NCT02363959|183419087|OTHER|||||||1|||||||Fisher Exact|||||||1
91765133|NCT02363959|183419088|OTHER|||||||1|||||||Fisher Exact|||||||1
91765134|NCT03421106|183419090|SUPERIORITY||Mean Difference (Net)|2.53||||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
91544639|NCT00520546|182968010|SUPERIORITY_OR_OTHER||sensitivity|70.0|||<|0.0001|TWO_SIDED|95.0|53.0|84.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||84|53|<0.0001
91544640|NCT00520546|182968010|SUPERIORITY_OR_OTHER||specificity|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|<0.0001
91544641|NCT00520546|182968010|SUPERIORITY_OR_OTHER||accuracy|68.0|||<|0.0001|TWO_SIDED|95.0|51.0|83.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||83|51|<0.0001
91544642|NCT00520546|182968010|SUPERIORITY_OR_OTHER||sensitivity|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
91765135|NCT00650845|183419146|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-7.9|6.7||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%Confidence Interval (CI) of the difference (non-enhanced - Dotarem®-enhanced) was \[-7.9%; +6.7%\]||6.7|-7.9|
91765136|NCT00650845|183419147|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.291
91765137|NCT00650845|183419148|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-14.1|8.9||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%CI of the difference (non-enhanced - Dotarem®-enhanced) was \[-14.1%; +8.9%\]||8.9|-14.1|
91765138|NCT00650845|183419149|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.040
91765139|NCT00650845|183419150|SUPERIORITY_OR_OTHER|||||||0.301|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.301
91765140|NCT00650845|183419151|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.051
91765141|NCT01525615|183419180|SUPERIORITY_OR_OTHER||Treatment ratio|1.138|STANDARD_ERROR_OF_MEAN|0.063||0.0209|TWO_SIDED|95.0|1.02|1.269||Mixed effects Model for Repeated Measures (MMRM) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time), log10 (baseline endurance time) by test day interaction, and patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.269|1.020|0.0209
91544643|NCT00520546|182968010|SUPERIORITY_OR_OTHER||specificity|100.0||||0.0043|TWO_SIDED|95.0|3.0|100.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|3|0.0043
91544644|NCT00520546|182968010|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
91544645|NCT00520546|182968011|SUPERIORITY_OR_OTHER||positive prediction|69.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
91544646|NCT00520546|182968011|SUPERIORITY_OR_OTHER||negative prediction|44.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
91544647|NCT00520546|182968011|SUPERIORITY_OR_OTHER||sensitivity|71.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
91544648|NCT00520546|182968011|SUPERIORITY_OR_OTHER||specificity|42.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
91765142|NCT01525615|183419180|SUPERIORITY_OR_OTHER||Treatment ratio|1.086|STANDARD_ERROR_OF_MEAN|0.061||0.1419|TWO_SIDED|95.0|0.973|1.213||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. This treatment comparison is the second one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.213|0.973|0.1419
91765143|NCT01525615|183419180|SUPERIORITY_OR_OTHER||Treatment ratio|1.047|STANDARD_ERROR_OF_MEAN|0.057||0.397|TWO_SIDED|95.0|0.941|1.166||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.166|0.941|0.3970
91544649|NCT00520546|182968011|SUPERIORITY_OR_OTHER||accuracy|61.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
91544650|NCT00520546|182968011|SUPERIORITY_OR_OTHER||positive prediction|60.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
91544651|NCT00520546|182968011|SUPERIORITY_OR_OTHER||negative prediction|30.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
91544652|NCT00520546|182968011|SUPERIORITY_OR_OTHER||sensitivity|48.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
91544653|NCT00520546|182968011|SUPERIORITY_OR_OTHER||specificity|40.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
91544654|NCT00520546|182968011|SUPERIORITY_OR_OTHER||accuracy|45.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
91544655|NCT00520546|182968011|SUPERIORITY_OR_OTHER||positive prediction|87.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544656|NCT00520546|182968011|SUPERIORITY_OR_OTHER||negative prediction|57.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544657|NCT00520546|182968011|SUPERIORITY_OR_OTHER||sensitivity|66.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91765144|NCT01525615|183419181|SUPERIORITY_OR_OTHER||Tretament ratio|1.209|STANDARD_ERROR_OF_MEAN|0.119||0.0552|TWO_SIDED|95.0|0.996|1.467||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Since the hierarchical testing chain has been broken, even though this treatment comparison is included as the 3rd one in the alpha-protected hierarchical testing chain, this hypothesis test is descriptive only.||1.467|0.996|0.0552
91544658|NCT00520546|182968011|SUPERIORITY_OR_OTHER||specificity|82.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544659|NCT00520546|182968011|SUPERIORITY_OR_OTHER||accuracy|72.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544660|NCT00520546|182968012|SUPERIORITY_OR_OTHER||positive prediction|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544661|NCT00520546|182968012|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544662|NCT00520546|182968012|SUPERIORITY_OR_OTHER||sensitivity|90.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91765145|NCT01525615|183419181|SUPERIORITY_OR_OTHER||Treatment ratio|1.211|STANDARD_ERROR_OF_MEAN|0.121||0.0562|TWO_SIDED|95.0|0.995|1.475||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean, 95% confidence limits transformed from log10 to original scale. SE was calculated using the delta method. This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.475|0.995|0.0562
91765146|NCT01525615|183419181|SUPERIORITY_OR_OTHER||Treatment ratio|0.998|STANDARD_ERROR_OF_MEAN|0.095||0.9822|TWO_SIDED|95.0|0.826|1.205||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.205|0.826|0.9822
91765147|NCT01525615|183419182|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.234|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.133|0.336||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|LSMean=Least square mean.|||0.336|0.133|<0.0001
91544663|NCT00520546|182968012|SUPERIORITY_OR_OTHER||specificity|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544664|NCT00520546|182968012|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544665|NCT00520546|182968012|SUPERIORITY_OR_OTHER||positive prediction|71.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
91544666|NCT00520546|182968012|SUPERIORITY_OR_OTHER||negative prediction|33.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
91544667|NCT00520546|182968012|SUPERIORITY_OR_OTHER||sensitivity|73.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
91544668|NCT00520546|182968012|SUPERIORITY_OR_OTHER||specificity|31.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
91544669|NCT00520546|182968012|SUPERIORITY_OR_OTHER||accuracy|60.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
91544670|NCT00520546|182968012|SUPERIORITY_OR_OTHER||positive prediction|96.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544671|NCT00520546|182968012|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544672|NCT00520546|182968012|SUPERIORITY_OR_OTHER||sensitivity|87.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544673|NCT00520546|182968012|SUPERIORITY_OR_OTHER||specificity|92.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544674|NCT00520546|182968012|SUPERIORITY_OR_OTHER||accuracy|88.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544675|NCT00520546|182968013|SUPERIORITY_OR_OTHER||positive prediction|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
91544676|NCT00520546|182968013|SUPERIORITY_OR_OTHER||negative prediction|69.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
91544677|NCT00520546|182968013|SUPERIORITY_OR_OTHER||sensitivity|86.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
91544678|NCT00520546|182968013|SUPERIORITY_OR_OTHER||specificity|43.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
91544679|NCT00520546|182968013|SUPERIORITY_OR_OTHER||accuracy|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
91544680|NCT00520546|182968013|SUPERIORITY_OR_OTHER||positive prediction|59.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
91544681|NCT00520546|182968013|SUPERIORITY_OR_OTHER||negative prediction|46.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
91544682|NCT00520546|182968013|SUPERIORITY_OR_OTHER||sensitivity|66.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
91544683|NCT00520546|182968013|SUPERIORITY_OR_OTHER||specificity|38.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
91544684|NCT00520546|182968013|SUPERIORITY_OR_OTHER||accuracy|54.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
91544685|NCT00520546|182968013|SUPERIORITY_OR_OTHER||positive prediction|86.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544686|NCT00520546|182968013|SUPERIORITY_OR_OTHER||negative prediction|76.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544687|NCT00520546|182968013|SUPERIORITY_OR_OTHER||sensitivity|83.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544688|NCT00520546|182968013|SUPERIORITY_OR_OTHER||specificity|80.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544689|NCT00520546|182968013|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
91544690|NCT05052996|182968037|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-6.8|11.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||11.6|-6.8|
91544691|NCT05052996|182968038|OTHER||Difference in percentage|-1.9|||||TWO_SIDED|95.0|-12.4|8.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||8.6|-12.4|
91544692|NCT05052996|182968039|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-8.6|12.4|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||12.4|-8.6|
91544693|NCT05052996|182968040|OTHER||difference in least squares means|-68.0||||0.3859|TWO_SIDED|95.0|-226.0|91.0|||ANOVA||P-value, difference in least squares means (Diff in LSM), and its 95% confidence interval (CI) were from ANOVA model with treatment group as a fixed effect in the model.|||91|-226|0.3859
91544694|NCT05052996|182968040|OTHER||difference in least squares means|13.0||||0.7085|TWO_SIDED|95.0|-56.0|82.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||82|-56|0.7085
91544695|NCT05052996|182968041|OTHER||difference in least squares means|33.0||||0.3477|TWO_SIDED|95.0|-37.0|103.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||103|-37|0.3477
91544696|NCT05052996|182968042|OTHER||difference in least squares means|-5.0||||0.8849|TWO_SIDED|95.0|-76.0|66.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||66|-76|0.8849
91544697|NCT00780234|182968090|OTHER||Regression model parameter (α1)|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.53|TWO_SIDED|95.0|-1.68|0.89|||Regression, Linear|The estimates of treatment effect were adjusted for baseline histology values.||"The hypotheses tested were:~H0: α1 = 0 vs H1: α1 \~= 0"|The hypothesis test was a 2-sided t-test of the effect of group (i.e. the difference between the pioglitazone and placebo groups). The general form of the model is Y = α0 + α1GROUP + α2BASELINE. Y represents the 6-month value of the dependent variable (summary of the histology), GROUP represents a classification variable for the treatment group (1=pioglitazone, 2=placebo), BASELINE represents the value of the outcome measure at baseline, and α0, α1 and α2 represent the parameter estimates from the general linear model. The test of the difference between groups will be the formal test of significance of the α1 parameter.|0.89|-1.68|0.53
91544698|NCT03570892|182968125|SUPERIORITY||Unadjusted stratified cox model hazard r|1.07|||=|0.694|TWO_SIDED|95.0|0.82|1.4|||Stratified log-rank test one-sided|||||1.40|0.82|= 0.694
91544699|NCT05028582|182968137|SUPERIORITY||Odds Ratio, log|5.19|||<|0.0001|TWO_SIDED|97.5|2.9|9.31|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|S-IGA Success at Week 8||9.31|2.90|<0.0001
91544700|NCT05028582|182968138|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|97.5|1.75|5.73|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|B-IGA Success at Week 8||5.73|1.75|<0.0001
91544701|NCT05028582|182968139|OTHER|SI-NRS Success at Week 4|Odds Ratio (OR)|4.67||||0.0005|TWO_SIDED|97.5|1.6|13.62|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||13.62|1.60|0.0005
91544702|NCT05028582|182968140|SUPERIORITY||Odds Ratio (OR)|4.39|||<|0.0001|TWO_SIDED|97.5|2.01|9.55|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|SI-NRS Success at Week 4||9.55|2.01|<0.0001
91544703|NCT05028582|182968141|OTHER|SI-NRS Success at Week 8|Odds Ratio (OR)|5.41|||<|0.0001|TWO_SIDED|97.5|2.49|11.78|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||11.78|2.49|<0.0001
91544704|NCT05028582|182968142|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.35||||0.0164|TWO_SIDED|97.5|-0.68|-0.02|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.02|-0.68|0.0164
91544705|NCT05028582|182968143|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.76|||<|0.0001|TWO_SIDED|97.5|-1.12|-0.39|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.39|-1.12|<0.0001
91544706|NCT05028582|182968144|SUPERIORITY|Change from Baseline in Weekly SI-NRS at Week 1|LS Mean Difference|-0.55||||0.0002|TWO_SIDED|97.5|-0.87|-0.22|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.22|-0.87|0.0002
91544707|NCT05028582|182968145|OTHER|WI-NRS Success at Week 8|Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|97.5|2.01|8.52|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||8.52|2.01|<0.0001
91544708|NCT05028582|182968146|SUPERIORITY|PASI-75 at Week 8|Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|97.5|2.73|10.75|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.75|2.73|<0.0001
91544709|NCT05028582|182968147|SUPERIORITY|PSD Aggregate Score Change at Week 8|LS Mean Difference|-5.12|||<|0.0001|TWO_SIDED|97.5|-6.64|-3.6|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|||-3.60|-6.64|<0.0001
91544710|NCT05028582|182968148|SUPERIORITY|PSD Itching Week 8|Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|97.5|2.1|10.04|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.04|2.10|<0.0001
91544711|NCT05028582|182968149|SUPERIORITY|PSD Pain Week 8|Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|97.5|1.83|5.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||5.68|1.83|<0.0001
91544712|NCT05028582|182968150|SUPERIORITY|PSD Scaling Week 8|Odds Ratio (OR)|4.56|||<|0.0001|TWO_SIDED|97.5|2.28|9.08|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.08|2.28|<0.0001
91544713|NCT05028582|182968151|OTHER|PSD Total Score 0 at Week 8|Odds Ratio (OR)|3.27||||0.0012|TWO_SIDED|97.5|1.39|7.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||7.68|1.39|0.0012
91544714|NCT05028582|182968152|SUPERIORITY|PSSI-75 at Week 8|Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|97.5|2.98|9.77|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|||9.77|2.98|<0.0001
91765148|NCT01525615|183419182|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.207|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.105|0.309||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.309|0.105|<0.0001
91544715|NCT05028582|182968153|SUPERIORITY|S-IGA Clear at Week 8|Odds Ratio (OR)|6.77|||<|0.0001|TWO_SIDED|97.5|3.04|15.05|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||15.05|3.04|<0.0001
91544716|NCT05028582|182968154|SUPERIORITY|S-IGA Success Week 2|Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|97.5|1.84|9.13|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.13|1.84|<0.0001
91544717|NCT05028582|182968155|SUPERIORITY|S-IGA Success at Week 4|Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|97.5|2.62|8.84|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||8.84|2.62|<0.0001
91544718|NCT05028582|182968156|SUPERIORITY|Change from Baseline in PASI Week 2|LS Mean Difference|-1.28|||<|0.0001|TWO_SIDED|97.5|-1.71|-0.85|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|||-0.85|-1.71|<0.0001
91544719|NCT04869982|182968207|OTHER|VE was defined as 1 minus the relative risk (RR). RR was defined as the ratio of the incidence rates of the RZV Group over the Placebo Group. The VE of RZV against HZ was to be demonstrated if the lower limit (LL) of the two-sided 95% CI of VE was above 25%.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|89.82|100.0||All p-values reported were related to the null hypothesis test VE = 0.|Poisson|The CI for VE is derived from the exact CI from RR.||To demonstrate the vaccine efficacy (VE) of RZV against HZ, the analysis considered the exact inference on the relative risk adjusted for age strata conditionally to the total number of confirmed HZ cases observed and time at risk. This method computed an exact confidence interval (CI) around the rate ratio (ratio of the event rates in the RZV Group versus Placebo Group) and accounted for the sum of the time at risk of the participants within each group.||100|89.82|<0.0001
91544720|NCT05215847|182968235|OTHER|Adverse event subject incidence and event frequency.|||||||||||||||||Adverse event subject incidence and event frequency.|||
91544721|NCT03830177|182968273|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91544722|NCT03830177|182968274|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91544723|NCT03830177|182968275|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91544724|NCT03830177|182968276|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91544725|NCT03830177|182968278|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91544726|NCT06023082|182968299|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91765149|NCT01525615|183419182|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.027|STANDARD_ERROR_OF_MEAN|0.05||0.5892|TWO_SIDED|95.0|-0.072|0.126||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.126|-0.072|0.5892
91765150|NCT01525615|183419183|SUPERIORITY_OR_OTHER||Treatment ratio|1.126|STANDARD_ERROR_OF_MEAN|0.059||0.0245|TWO_SIDED|95.0|1.015|1.248||ANCOVA model for log10 (endurance time \[s\]) with categorical effects of treatment and (log10-transformed) baseline as continuous covariate.|ANCOVA|This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo||1.248|1.015|0.0245
91765151|NCT01525615|183419183|SUPERIORITY_OR_OTHER||Treatment ratio|1.103|STANDARD_ERROR_OF_MEAN|0.058||0.0655|TWO_SIDED|95.0|0.994|1.223|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.223|0.994|0.0655
91765152|NCT01525615|183419183|SUPERIORITY_OR_OTHER||Treatment ratio|1.021|STANDARD_ERROR_OF_MEAN|0.053||0.6912|TWO_SIDED|95.0|0.921|1.132|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0||1.132|0.921|0.6912
91544727|NCT06023082|182968300|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91544728|NCT06023082|182968301|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544729|NCT06023082|182968302|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544730|NCT06023082|182968303|OTHER|||||||0.4907||||||Baseline to Week 12 comparison.|ANOVA|||||||0.4907
91544731|NCT06023082|182968304|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544732|NCT06023082|182968305|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544733|NCT06023082|182968306|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544734|NCT06023082|182968307|OTHER|||||||0.0016||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0016
91544735|NCT06023082|182968308|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544736|NCT06023082|182968309|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544737|NCT06023082|182968310|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544738|NCT06023082|182968311|OTHER|||||||0.0002||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0002
91765153|NCT01525615|183419184|SUPERIORITY_OR_OTHER||Treatment ratio|1.229|STANDARD_ERROR_OF_MEAN|0.068||0.0002|TWO_SIDED|95.0|1.103|1.37||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Hypothesis test is descriptive||1.370|1.103|0.0002
91765154|NCT01525615|183419184|SUPERIORITY_OR_OTHER||Treatment ratio|1.221|STANDARD_ERROR_OF_MEAN|0.068||0.0004|TWO_SIDED|95.0|1.095|1.362||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. Hypothesis test is descriptive.||1.362|1.095|0.0004
91765155|NCT01525615|183419184|SUPERIORITY_OR_OTHER||Treatment ratio|1.006|STANDARD_ERROR_OF_MEAN|0.055||0.9062|TWO_SIDED|95.0|0.905|1.12||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. Hypothesis test is descriptive.||1.12|0.905|0.9062
91765156|NCT01525615|183419185|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.165|STANDARD_ERROR_OF_MEAN|0.058||0.0049|TWO_SIDED|95.0|0.051|0.279||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.279|0.051|0.0049
91765157|NCT01525615|183419185|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.202|STANDARD_ERROR_OF_MEAN|0.058||0.0006|TWO_SIDED|95.0|0.088|0.316||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.316|0.088|0.0006
91765158|NCT01525615|183419185|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.037|STANDARD_ERROR_OF_MEAN|0.058||0.5162|TWO_SIDED|95.0|-0.151|0.076||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.076|-0.151|0.5162
91765159|NCT01525615|183419186|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.225|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.124|0.326||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.326|0.124|<0.0001
91765160|NCT01525615|183419186|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.187|STANDARD_ERROR_OF_MEAN|0.052||0.0003|TWO_SIDED|95.0|0.086|0.288||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.288|0.086|0.0003
91765161|NCT01525615|183419186|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.038|STANDARD_ERROR_OF_MEAN|0.05||0.4541|TWO_SIDED|95.0|-0.061|0.137||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.137|-0.061|0.4541
91765162|NCT01525615|183419187|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0468|TWO_SIDED|95.0|-0.004|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.004|0.0468
91544739|NCT06023082|182968312|OTHER|||||||0.001||||||Baseline to Week 12 comparison.|ANOVA|||||||0.001
91544740|NCT06023082|182968313|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544741|NCT06023082|182968314|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544742|NCT06023082|182968315|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544743|NCT06023082|182968316|OTHER||||||<|0.0001|||||||ANOVA|||Baseline to Week 12 comparison.||||<0.0001
91544744|NCT06023082|182968317|OTHER||||||<|0.0001||||||Baseline to Week 10 comparison.|ANOVA|||||||<0.0001
91544745|NCT06023082|182968318|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544746|NCT06023082|182968319|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544747|NCT06023082|182968320|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544748|NCT06023082|182968321|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
91544749|NCT05986565|182968323|SUPERIORITY|||||||0.587|||||||RMANOVA|1||||||0.587
91765163|NCT01525615|183419187|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|-0.005|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.005|0.0180
91544750|NCT05986565|182968324|SUPERIORITY|||||||0.874|||||||RMANOVA|1||||||0.874
91544751|NCT05986565|182968325|SUPERIORITY|||||||0.946|||||||RMANOVA|1||||||0.946
91765164|NCT01525615|183419187|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6856|TWO_SIDED|95.0|-0.002|0.002||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.002|-0.002|0.6856
91765165|NCT01525615|183419188|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0081|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0081
91544752|NCT05986565|182968326|SUPERIORITY|||||||0.267|||||||t-test, 2 sided|24||||||0.267
91544753|NCT05986565|182968327|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|df=25||||||0.187
91544754|NCT05986565|182968328|SUPERIORITY|||||||0.765|||||||t-test, 2 sided|df=24||||||0.765
91544755|NCT05986565|182968329|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|df=25||||||0.060
91544756|NCT05986565|182968330|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|df=24||||||0.608
91544757|NCT05986565|182968331|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|df=25||||||0.638
91544758|NCT06459401|182968408|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.131|TWO_SIDED|95.0|-0.01|0.07||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.525|Difference = Preferred Timing - Non-Preferred Timing|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.07|-0.01|0.131
91544759|NCT06459401|182968409|OTHER|Single group test of difference.|Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.35||0.001|TWO_SIDED|95.0|0.99|2.56||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 1.623|Difference = Preferred Timing - Non-Preferred Timing|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||2.56|0.99|0.001
91544760|NCT06459401|182968410|OTHER|Single group test of difference.|Mean Difference (Final Values)|3.32|STANDARD_ERROR_OF_MEAN|1.14||0.017|TWO_SIDED|95.0|0.75|5.89||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.923|Difference = Preferred Timing - Non-Preferred Timing|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||5.89|0.75|0.017
91544761|NCT06459401|182968411|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.016||0.874|TWO_SIDED|95.0|-0.034|0.039||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.052|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.039|-0.034|0.874
91544762|NCT06459401|182968412|OTHER|Single group test of difference.|Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.36||0.345|TWO_SIDED|95.0|-1.18|0.46||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = -0.315|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.46|-1.18|0.345
91544763|NCT06459401|182968413|OTHER|Single group test of difference.|Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|0.78||0.024|TWO_SIDED|95.0|-3.9|-0.36||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = -0.859|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||-0.36|-3.90|0.024
91544764|NCT06459401|182968414|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.044|TWO_SIDED|95.0|0.0|0.06||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.739|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.06|0.00|0.044
91765166|NCT01525615|183419188|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0099|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0099
91765167|NCT01525615|183419188|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9626|TWO_SIDED|95.0|-0.002|0.002||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.002|-0.002|0.9626
91765168|NCT01525615|183419189|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0598|TWO_SIDED|95.0|-0.004|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.000|-0.004|0.0598
91544765|NCT06459401|182968415|OTHER|Single group test of difference.|Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|0.48||0.017|TWO_SIDED|95.0|0.32|2.5||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.928|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||2.50|0.32|0.017
91544766|NCT06459401|182968416|OTHER|Single group test of difference.|Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|1.26||0.372|TWO_SIDED|95.0|-1.67|4.04||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.297|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||4.04|-1.67|0.372
91544767|NCT06459401|182968417|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|0.07|0.2||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 1.508|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.20|0.07|0.001
91544768|NCT06459401|182968418|OTHER|Single group test of difference.|Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|0.95||0.043|TWO_SIDED|95.0|0.09|4.39||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.746|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||4.39|0.09|0.043
91544769|NCT06459401|182968419|OTHER|Single group test of difference.|Mean Difference (Final Values)|4.53|STANDARD_ERROR_OF_MEAN|1.9||0.041|TWO_SIDED|95.0|0.22|8.83||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.752|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||8.83|0.22|0.041
91544770|NCT06459401|182968420|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.013|TWO_SIDED|95.0|0.03|0.21||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.983|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.21|0.03|0.013
91765169|NCT01525615|183419189|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0218|TWO_SIDED|95.0|-0.005|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.000|-0.005|0.0218
91544771|NCT06459401|182968421|OTHER|Single group test of difference.|Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|0.52||0.012|TWO_SIDED|95.0|0.44|2.78||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.985|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||2.78|0.44|0.012
91765170|NCT01525615|183419189|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6549|TWO_SIDED|95.0|-0.002|0.003||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.003|-0.002|0.6549
91765171|NCT01525615|183419190|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.116|0.224||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.224|0.116|<0.0001
91544772|NCT06459401|182968422|OTHER|Single group test of difference.|Mean Difference (Final Values)|4.75|STANDARD_ERROR_OF_MEAN|1.93||0.036|TWO_SIDED|95.0|0.39|9.11||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.779|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||9.11|0.39|0.036
91765172|NCT01525615|183419190|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.184|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.129|0.239||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.239|0.129|<0.0001
91765173|NCT01525615|183419190|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6105|TWO_SIDED|95.0|-0.067|0.04||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.040|-0.067|0.6105
91765174|NCT01525615|183419191|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.192|0.3||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.300|0.192|<0.0001
91765175|NCT01525615|183419191|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.273|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.218|0.328||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.328|0.218|<0.0001
91765176|NCT01525615|183419191|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3236|TWO_SIDED|95.0|-0.08|0.027||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.027|-0.080|0.3236
91765177|NCT01525615|183419192|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.196|0.305||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.305|0.196|<0.0001
91765178|NCT01525615|183419192|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.257|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.202|0.312||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.312|0.202|<0.0001
91544773|NCT06459401|182968427|OTHER|Single group test of difference.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.54||0.962|TWO_SIDED|95.0|-1.24|1.19||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = -0.015|Difference = Preferred Timing - Non-Preferred Timing|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||1.19|-1.24|0.962
91544774|NCT06459401|182968428|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.09||0.146|TWO_SIDED|95.0|-0.06|0.35||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.504|Difference = Preferred Timing - Non-Preferred Timing|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.35|-0.06|0.146
91544775|NCT06459401|182968429|OTHER|Single group test of difference.|Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|0.95||0.152|TWO_SIDED|95.0|-0.66|3.63||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.495|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||3.63|-0.66|0.152
91544776|NCT06459401|182968430|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.08||0.153|TWO_SIDED|95.0|-0.06|0.31||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.494|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.31|-0.06|0.153
91544777|NCT06459401|182968431|OTHER|Single group test of difference.|Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|0.94||0.155|TWO_SIDED|95.0|-0.67|3.58||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.491|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||3.58|-0.67|0.155
91765179|NCT01525615|183419192|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.006|STANDARD_ERROR_OF_MEAN|0.027||0.8156|TWO_SIDED|95.0|-0.06|0.047||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.047|-0.060|0.8156
91544778|NCT06459401|182968432|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|0.11|0.43||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 1.199|Difference = Assisted - Unassisted|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.43|0.11|0.004
91765180|NCT00330759|183419215|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.84||||0.0007||95.0|0.71|0.98|||Regression, Cox|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||||0.98|0.71|0.0007
91544779|NCT06459401|182968433|OTHER|Single group test of difference.|Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.72||0.014|TWO_SIDED|95.0|-3.82|-0.56||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = -0.962|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||-0.56|-3.82|0.014
91544780|NCT06459401|182968434|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.35|TWO_SIDED|95.0|-0.26|0.66||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.312|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.66|-0.26|0.350
91544781|NCT06459401|182968435|OTHER|Single group test of difference.|Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.81||0.052|TWO_SIDED|95.0|-3.63|0.02||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = -0.706|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.02|-3.63|0.052
91544782|NCT06459401|182968436|OTHER|Single group test of difference.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11||0.221|TWO_SIDED|95.0|-0.1|0.39||alpha = 0.05|t-test, 2 sided|Effect Size (Cohen's D) = 0.416|Difference = Post-Session - Pre-Session|An a priori power analysis (G\*Power 3.1.9.7) determined that a sample size of 10 participants could detect an effect size (Cohen's D) of 1.0 with 80% power and alpha = 0.05.||0.39|-0.10|0.221
91544783|NCT02740231|182968465|SUPERIORITY||Adjusted mean difference|-9.49|STANDARD_DEVIATION|6.38||0.141|TWO_SIDED|95.0|-22.21|3.23||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference - adjusted mean change|The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.||3.23|-22.21|0.141
91544784|NCT02740231|182968466|SUPERIORITY||Adjusted mean difference|-11.63|STANDARD_DEVIATION|5.5||0.038|TWO_SIDED|95.0|-22.6|-0.66||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference|||-0.66|-22.60|0.038
91544785|NCT02740231|182968467|SUPERIORITY||Adjusted mean difference|-1.48|STANDARD_DEVIATION|4.35||0.997|TWO_SIDED|95.0|-12.7|9.74||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||9.74|-12.70|0.997
91544786|NCT02740231|182968468|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_DEVIATION|5.3||0.972|TWO_SIDED|95.0|-16.52|10.65||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||10.65|-16.52|0.972
91765181|NCT00330759|183419216|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.06||95.0|0.71|0.98|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||0.98|0.71|0.060
91765182|NCT00330759|183419217|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.145||95.0|0.77|1.04|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||1.04|0.77|0.145
91544787|NCT02740231|182968469|SUPERIORITY||Adjusted mean difference|-7.17|STANDARD_DEVIATION|5.96||0.599|TWO_SIDED|95.0|-22.28|7.94||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||7.94|-22.28|0.599
91544788|NCT02740231|182968470|SUPERIORITY||Adjusted mean difference|-6.62|STANDARD_DEVIATION|4.3||0.126|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.126
91544789|NCT02740231|182968471|SUPERIORITY||Adjusted mean difference|-8.88|STANDARD_DEVIATION|4.76||0.064|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.064
91544790|NCT02740231|182968472|SUPERIORITY||Adjusted mean difference|-10.79|STANDARD_DEVIATION|4.35||0.014|TWO_SIDED|95.0|||||ANCOVA|||||||0.014
91544791|NCT02740231|182968473|SUPERIORITY||Adjusted mean difference|-10.57|STANDARD_DEVIATION|4.81||0.03|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.030
91544792|NCT00914589|182968486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0482||||0.8648||95.0|0.6095|1.8029||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.8029|0.6095|0.8648
91544793|NCT00914589|182968486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9871||||0.9634||95.0|0.5673|1.7176||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.7176|0.5673|0.9634
91544794|NCT03988023|182968491|SUPERIORITY|||||||0.32|||||||MMRM|||||||0.32
91544795|NCT03988023|182968492|SUPERIORITY|||||||0.3|||||||MMRM|||||||0.30
91544796|NCT02554786|182968579|SUPERIORITY||Least Square mean (LS Mean)|0.132|STANDARD_ERROR_OF_MEAN|0.0223|<|0.001|TWO_SIDED|95.0|0.088|0.176|||Mixed Model for Repeated Measures (MMRM)|||||0.176|0.088|<0.001
91544797|NCT02554786|182968579|SUPERIORITY||LS Mean|0.211|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.167|0.255|||MMRM|||||0.255|0.167|<0.001
91544798|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.172|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|-0.254|-0.091|||MMRM|||Week 4||-0.091|-0.254|<0.001
91544799|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.196|STANDARD_ERROR_OF_MEAN|0.0416|<|0.001|TWO_SIDED|95.0|-0.278|-0.115|||MMRM|||Week 4||-0.115|-0.278|<0.001
91544800|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.055|STANDARD_ERROR_OF_MEAN|0.0414||0.186|TWO_SIDED|95.0|-0.136|0.026|||MMRM|||Week 4||0.026|-0.136|0.186
91544801|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.184|STANDARD_ERROR_OF_MEAN|0.0294|<|0.001|TWO_SIDED|95.0|-0.242|-0.127|||MMRM|||Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.127|-0.242|<0.001
91544802|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0431||0.003|TWO_SIDED|95.0|-0.214|-0.044|||MMRM|||Week 12||-0.044|-0.214|0.003
91544803|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0435|<|0.001|TWO_SIDED|95.0|-0.333|-0.162|||MMRM|||Week 12||-0.162|-0.333|<0.001
91544804|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.052|STANDARD_ERROR_OF_MEAN|0.0431||0.232|TWO_SIDED|95.0|-0.136|0.033|||MMRM|||Week 12||0.033|-0.136|0.232
91544805|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.188|STANDARD_ERROR_OF_MEAN|0.0307|<|0.001|TWO_SIDED|95.0|-0.248|-0.128|||MMRM|||Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.128|-0.248|<0.001
91544806|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.171|STANDARD_ERROR_OF_MEAN|0.0437|<|0.001|TWO_SIDED|95.0|-0.257|-0.086|||MMRM|||Week 26||-0.086|-0.257|<0.001
91544807|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0439|<|0.001|TWO_SIDED|95.0|-0.334|-0.162|||MMRM|||Week 26||-0.162|-0.334|<0.001
91544808|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0437||0.214|TWO_SIDED|95.0|-0.14|0.031|||MMRM|||Week 26||0.031|-0.140|0.214
91544809|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.209|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.27|-0.149|||MMRM|||Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.149|-0.270|<0.001
91544810|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.141|STANDARD_ERROR_OF_MEAN|0.0449||0.002|TWO_SIDED|95.0|-0.229|-0.053|||MMRM|||Week 52||-0.053|-0.229|0.002
91544811|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.266|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.354|-0.177|||MMRM|||Week 52||-0.177|-0.354|<0.001
91544812|NCT02554786|182968580|SUPERIORITY||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0447||0.824|TWO_SIDED|95.0|-0.078|0.098|||MMRM|||Week 52||0.098|-0.078|0.824
91544813|NCT02554786|182968580|SUPERIORITY||LS Mean|-0.203|STANDARD_ERROR_OF_MEAN|0.0318|<|0.001|TWO_SIDED|95.0|-0.266|-0.141|||MMRM|||Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.141|-0.266|<0.001
91544814|NCT02554786|182968581|SUPERIORITY||LS Mean|0.136|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.09|0.183|||MMRM|||||0.183|0.090|<0.001
91544815|NCT02554786|182968581|SUPERIORITY||LS Mean|0.209|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.163|0.255|||MMRM|||||0.255|0.163|<0.001
91544816|NCT02554786|182968581|SUPERIORITY||LS Mean|0.048|STANDARD_ERROR_OF_MEAN|0.0234||0.04|TWO_SIDED|95.0|0.002|0.094|||MMRM|||||0.094|0.002|0.04
91544817|NCT02554786|182968582|SUPERIORITY||LS Mean|0.132|STANDARD_ERROR_OF_MEAN|0.0193|<|0.001|TWO_SIDED|95.0|0.094|0.17|||MMRM|||Day 30||0.170|0.094|<0.001
91544818|NCT02554786|182968582|SUPERIORITY||LS Mean|0.196|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.158|0.234|||MMRM|||Day 30||0.234|0.158|<0.001
91544819|NCT02554786|182968582|SUPERIORITY||LS Mean|0.035|STANDARD_ERROR_OF_MEAN|0.0192||0.064|TWO_SIDED|95.0|-0.002|0.073|||MMRM|||Day 30||0.073|-0.002|0.064
91544820|NCT02554786|182968582|SUPERIORITY||LS Mean|0.122|STANDARD_ERROR_OF_MEAN|0.0201|<|0.001|TWO_SIDED|95.0|0.083|0.162|||MMRM|||Day 86||0.162|0.083|<0.001
91544821|NCT02554786|182968582|SUPERIORITY||LS Mean|0.184|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|0.144|0.224|||MMRM|||Day 86||0.224|0.144|<0.001
91544822|NCT02554786|182968582|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.002|0.076|||MMRM|||Day 86||0.076|-0.002|0.063
91544823|NCT02554786|182968583|SUPERIORITY||LS Mean|0.142|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.119|0.164|||MMRM|||Day 1: 5 minutes||0.164|0.119|<0.001
91544824|NCT02554786|182968583|SUPERIORITY||LS Mean|0.152|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.129|0.175|||MMRM|||Day 1: 5 minutes||0.175|0.129|<0.001
91544825|NCT02554786|182968583|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.032|0.078|||MMRM|||Day 1: 5 minutes||0.078|0.032|<0.001
91544826|NCT02554786|182968583|SUPERIORITY||LS Mean|0.162|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.138|0.186|||MMRM|||Day 1: 15 minutes||0.186|0.138|<0.001
91544827|NCT02554786|182968583|SUPERIORITY||LS mean|0.174|STANDARD_ERROR_OF_MEAN|0.0123|<|0.001|TWO_SIDED|95.0|0.15|0.198|||MMRM|||Day 1: 15 minutes||0.198|0.150|<.001
91544828|NCT02554786|182968583|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.02|0.068|||MMRM|||Day1: 15 minutes||0.068|0.02|<0.001
91544829|NCT02554786|182968583|SUPERIORITY||LS Mean|0.175|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.149|0.201|||MMRM|||Day 1: 30 minutes||0.201|0.149|<0.001
91544830|NCT02554786|182968583|SUPERIORITY||LS Mean|0.185|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.159|0.211|||MMRM|||Day 1: 30 minutes||0.211|0.159|<0.001
91544831|NCT02554786|182968583|SUPERIORITY||LS Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0132||0.038|TWO_SIDED|95.0|0.001|0.053|||MMRM|||Day 1: 30 minutes||0.053|0.001|0.038
91544832|NCT02554786|182968583|SUPERIORITY||LS Mean|0.178|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.15|0.205|||MMRM|||Day 1: 1 hour||0.205|0.150|<0.001
91765183|NCT06083987|183419248|SUPERIORITY||Cohen's D|0.01||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|false discovery rate q-value calculated with Yekutieli method in Stata||||||0.86
91544833|NCT02554786|182968583|SUPERIORITY||LS Mean|0.205|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.177|0.232|||MMRM|||Day 1: 1hour||0.232|0.177|<0.001
91544834|NCT02554786|182968583|SUPERIORITY||LS Mean|0.007|STANDARD_ERROR_OF_MEAN|0.0139||0.632|TWO_SIDED|95.0|-0.021|0.034|||MMRM|||Day 1: 1hour||0.034|-0.021|0.632
91544835|NCT02554786|182968583|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0192|<|0.001|TWO_SIDED|95.0|0.151|0.226|||MMRM|||Day 30: 5 minutes||0.226|0.151|<0.001
91544836|NCT02554786|182968583|SUPERIORITY||LS Mean|0.232|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.194|0.27|||MMRM|||Day 30: 5 minutes||0.270|0.194|<0.001
91544837|NCT02554786|182968583|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0191||0.005|TWO_SIDED|95.0|0.016|0.091|||MMRM|||Day 30: 5 minutes||0.091|0.016|0.005
91765184|NCT06083987|183419249|SUPERIORITY||Cohen's D|0.32||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.31
91544838|NCT02554786|182968583|SUPERIORITY||LS Mean|0.194|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.156|0.232|||MMRM|||Day 30: 30 minutes||0.232|0.156|<0.001
91544839|NCT02554786|182968583|SUPERIORITY||LS Mean|0.253|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.214|0.291|||MMRM|||Day 30: 30 minutes||0.291|0.214|<0.001
91544840|NCT02554786|182968583|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0192||0.026|TWO_SIDED|95.0|0.005|0.08|||MMRM|||Day 30: 30 minutes||0.08|0.005|0.026
91544841|NCT02554786|182968583|SUPERIORITY||LS Mean|0.19|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.152|0.229|||MMRM|||Day 30: 1 hour||0.229|0.152|<0.001
91544842|NCT02554786|182968583|SUPERIORITY||LS Mean|0.258|STANDARD_ERROR_OF_MEAN|0.0198|<|0.001|TWO_SIDED|95.0|0.219|0.296|||MMRM|||Day 30: 1 hour||0.296|0.219|<0.001
91544843|NCT02554786|182968583|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.0194||0.059|TWO_SIDED|95.0|-0.001|0.075|||MMRM|||Day 30: 1 hour||0.075|-0.001|0.059
91544844|NCT02554786|182968583|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0204|<|0.001|TWO_SIDED|95.0|0.123|0.203|||MMRM|||Day 86: 5 minutes||0.203|0.123|<0.001
91544845|NCT02554786|182968583|SUPERIORITY||LS Mean|0.231|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|0.191|0.271|||MMRM|||Day 86: 5 minutes||0.271|0.191|<0.001
91544846|NCT02554786|182968583|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0203||0.007|TWO_SIDED|95.0|0.015|0.095|||MMRM|||Day 86: 5minutes||0.095|0.015|0.007
91544847|NCT02554786|182968583|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0203|<|0.001|TWO_SIDED|95.0|0.14|0.219|||MMRM|||Day 86: 30 minutes||0.219|0.140|<0.001
91544848|NCT02554786|182968583|SUPERIORITY||LS Mean|0.252|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.211|0.292|||MMRM|||Day 86: 30 minutes||0.292|0.211|<0.001
91544849|NCT02554786|182968583|SUPERIORITY||LS Mean|0.038|STANDARD_ERROR_OF_MEAN|0.0202||0.057|TWO_SIDED|95.0|-0.001|0.078|||MMRM|||Day 86: 30 minutes||0.078|-0.001|0.057
91544850|NCT02554786|182968583|SUPERIORITY||LS Mean|0.187|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.147|0.227|||MMRM|||Day 86: 1 hour||0.227|0.147|<0.001
91544851|NCT02554786|182968583|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0208|<|0.001|TWO_SIDED|95.0|0.208|0.289|||MMRM|||Day 86: 1 hour||0.289|0.208|<0.001
91544852|NCT02554786|182968583|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0205||0.037|TWO_SIDED|95.0|0.003|0.083|||MMRM|||Day 86: 1hour||0.083|0.003|0.037
91544853|NCT02554786|182968583|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.121|0.206|||MMRM|||Day 183: 5 minutes||0.206|0.121|<0.001
91544854|NCT02554786|182968583|SUPERIORITY||LS Mean|0.243|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.2|0.286|||MMRM|||Day 183: 5 minutes||0.286|0.200|<0.001
91544855|NCT02554786|182968583|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0216||0.041|TWO_SIDED|95.0|0.002|0.087|||MMRM|||Day 183: 5 minutes||0.087|0.002|0.041
91544856|NCT02554786|182968583|SUPERIORITY||LS Mean|0.176|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.133|0.22|||MMRM|||Day 183: 30 minutes||0.220|0.133|<0.001
91544857|NCT02554786|182968583|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.215|0.303|||MMRM|||Day 183: 30 minutes||0.303|0.215|<0.001
91544858|NCT02554786|182968583|SUPERIORITY||LS Mean|0.04|STANDARD_ERROR_OF_MEAN|0.0221||0.071|TWO_SIDED|95.0|-0.003|0.083|||MMRM|||Day 183: 30 minutes||0.083|-0.003|0.071
91544859|NCT02554786|182968583|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.137|0.223|||MMRM|||Day 183: 1 hour||0.223|0.137|<0.001
91765185|NCT06083987|183419250|SUPERIORITY||Cohen's D|0.1||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
91765186|NCT06083987|183419251|SUPERIORITY||Cohen's D|0.45||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91765187|NCT06083987|183419252|SUPERIORITY||Cohen's d|0.41||||0.22|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.22
91765188|NCT04473963|183419302|NON_INFERIORITY|Non-inferiority between subjects Randomized to Treatment vs subjects Randomized to Control||||||0.277|||||||Chi-squared|||||||0.277
91765189|NCT04473963|183419304|EQUIVALENCE|"Equivalence between subjects Randomized to Control and subjects Randomized to Treatment"||||||0.042|||||||Kaplan-Meyer Log Rank|||||||0.042
91765190|NCT04473963|183419309|EQUIVALENCE|"Equivalence between procedure time of subjects Randomized to Treatment and subjects Randomized to Control. The Not-Randomized group was not included in the analysis."|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91544860|NCT02554786|182968583|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.215|0.302|||MMRM|||Day 183: 1 hour||0.302|0.215|<0.001
91544861|NCT02554786|182968583|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.0218||0.071|TWO_SIDED|95.0|-0.003|0.082|||MMRM|||Day 183: 1 hour||0.082|-0.003|0.071
91544862|NCT02554786|182968583|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|95.0|0.094|0.184|||MMRM|||Day 364: 5 minutes||0.184|0.094|<0.001
91544863|NCT02554786|182968583|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.205|0.294|||MMRM|||Day 364: 5 minutes||0.294|0.205|<0.001
91544864|NCT02554786|182968583|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0227||0.244|TWO_SIDED|95.0|-0.018|0.071|||MMRM|||Day 364: 5 minutes||0.071|-0.018|0.244
91544865|NCT02554786|182968583|SUPERIORITY||LS Mean|0.155|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.11|0.2|||MMRM|||Day 364: 30 minutes||0.200|0.110|<0.001
91544866|NCT02554786|182968583|SUPERIORITY||LS Mean|0.264|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|95.0|0.219|0.308|||MMRM|||Day 364: 30 minutes||0.308|0.219|<0.001
91544867|NCT02554786|182968583|SUPERIORITY||LS Mean|0.032|STANDARD_ERROR_OF_MEAN|0.0226||0.162|TWO_SIDED|95.0|-0.013|0.076|||MMRM|||Day 364: 30 minutes||0.076|-0.013|0.162
91544868|NCT02554786|182968583|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0234|<|0.001|TWO_SIDED|95.0|0.117|0.209|||MMRM|||Day 364: 1 hour||0.209|0.117|<0.001
91544869|NCT02554786|182968583|SUPERIORITY||LS Mean|0.262|STANDARD_ERROR_OF_MEAN|0.0232|<|0.001|TWO_SIDED|95.0|0.216|0.308|||MMRM|||Day 364: 1 hour||0.308|0.216|<0.001
91544870|NCT02554786|182968583|SUPERIORITY||LS Mean|0.031|STANDARD_ERROR_OF_MEAN|0.0231||0.182|TWO_SIDED|95.0|-0.014|0.076|||MMRM|||Day 364: 1 hour||0.076|-0.014|0.182
91544871|NCT02554786|182968584|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0237|<|0.001|TWO_SIDED|95.0|0.04|0.133|||MMRM|||Day 2||0.133|0.040|<0.001
91544872|NCT02554786|182968584|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.093|0.185|||MMRM|||Day 2||0.185|0.093|<0.001
91544873|NCT02554786|182968584|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.0237||0.927|TWO_SIDED|95.0|-0.049|0.044|||MMRM|||Day 2||0.044|-0.049|0.927
91544874|NCT02554786|182968584|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0246||0.044|TWO_SIDED|95.0|0.001|0.098|||MMRM|||Day 184||0.098|0.001|0.044
91544875|NCT02554786|182968584|SUPERIORITY||LS Mean|0.141|STANDARD_ERROR_OF_MEAN|0.0246|<|0.001|TWO_SIDED|95.0|0.093|0.19|||MMRM|||Day 184||0.190|0.093|<0.001
91765191|NCT02123849|183419313|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.04|||||||t-test, 1 sided|||||||0.04
91765192|NCT02123849|183419314|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
91544876|NCT02554786|182968584|SUPERIORITY||LS Mean|0.017|STANDARD_ERROR_OF_MEAN|0.0244||0.49|TWO_SIDED|95.0|-0.031|0.065|||MMRM|||Day 184||0.065|-0.031|0.490
91544877|NCT02554786|182968584|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0249||0.002|TWO_SIDED|95.0|0.027|0.125|||MMRM|||Day 365||0.125|0.027|0.002
91544878|NCT02554786|182968584|SUPERIORITY||LS Mean|0.146|STANDARD_ERROR_OF_MEAN|0.0248|<|0.001|TWO_SIDED|95.0|0.098|0.195|||MMRM|||Day 365||0.195|0.098|<0.001
91544879|NCT02554786|182968584|SUPERIORITY||LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0248||0.143|TWO_SIDED|95.0|-0.012|0.085|||MMRM|||Day 365||0.085|-0.012|0.143
91544880|NCT02554786|182968585|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0253|<|0.001|TWO_SIDED|95.0|0.139|0.238|||MMRM|||Day 2||0.238|0.139|<0.001
91544881|NCT02554786|182968585|SUPERIORITY||LS Mean|0.21|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.161|0.259|||MMRM|||Day 2||0.259|0.161|<0.001
91544882|NCT02554786|182968585|SUPERIORITY||LS Mean|-0.018|STANDARD_ERROR_OF_MEAN|0.0252||0.475|TWO_SIDED|95.0|-0.067|0.031|||MMRM|||Day 2||0.031|-0.067|0.475
91544883|NCT02554786|182968585|SUPERIORITY||LS Mean|0.228|STANDARD_ERROR_OF_MEAN|0.0345|<|0.001|TWO_SIDED|95.0|0.161|0.296|||MMRM|||Day 184||0.296|0.161|<0.001
91544884|NCT02554786|182968585|SUPERIORITY||LS Mean|0.265|STANDARD_ERROR_OF_MEAN|0.0346|<|0.001|TWO_SIDED|95.0|0.197|0.333|||MMRM|||Day 184||0.333|0.197|<0.001
91544885|NCT02554786|182968585|SUPERIORITY||LS Mean|0.083|STANDARD_ERROR_OF_MEAN|0.0343||0.015|TWO_SIDED|95.0|0.016|0.151|||MMRM|||Day 184||0.151|0.016|0.015
91544886|NCT02554786|182968585|SUPERIORITY||LS Mean|0.215|STANDARD_ERROR_OF_MEAN|0.0358|<|0.001|TWO_SIDED|95.0|0.145|0.285|||MMRM|||Day 365||0.285|0.145|<0.001
91544887|NCT02554786|182968585|SUPERIORITY||LS Mean|0.246|STANDARD_ERROR_OF_MEAN|0.0357|<|0.001|TWO_SIDED|95.0|0.176|0.316|||MMRM|||Day 365||0.316|0.176|<0.001
91544888|NCT02554786|182968585|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0356||0.139|TWO_SIDED|95.0|-0.017|0.122|||MMRM|||Day 365||0.122|-0.017|0.139
91544889|NCT02554786|182968586|SUPERIORITY||LS Mean|29.6|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|23.8|35.4|||Linear Mixed Model (LMM)|||Week 26: Mean morning PEF||35.4|23.8|<0.001
91544890|NCT02554786|182968586|SUPERIORITY||LS Mean|32.2|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|26.4|38.1|||LMM|||Week 26: Mean morning PEF||38.1|26.4|<0.001
91544891|NCT02554786|182968586|SUPERIORITY||LS Mean|13.3|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|7.5|19.1|||LMM|||Week 26: Mean morning PEF||19.1|7.5|<0.001
91765193|NCT02123849|183419315|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
91765194|NCT02123849|183419316|OTHER|||||||1|||||||Fisher Exact|||||||1.00
91765195|NCT02123849|183419317|OTHER|||||||0.42|||||||t-test, 2 sided|||||||0.42
91765196|NCT02123849|183419318|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
91544892|NCT02554786|182968586|SUPERIORITY||LS Mean|24.8|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|19.3|30.3|||LMM|||Week 26: Mean evening PEF||30.3|19.3|<0.001
91544893|NCT02554786|182968586|SUPERIORITY||LS Mean|30.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|24.8|35.9|||LMM|||Week 26: Mean evening PEF||35.9|24.8|<0.001
91544894|NCT02554786|182968586|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.83||0.002|TWO_SIDED|95.0|3.1|14.2|||LMM|||Week 26: Mean evening PEF||14.2|3.1|0.002
91544895|NCT02554786|182968586|SUPERIORITY||LS Mean|28.7|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|22.7|34.8|||LMM|||Week 52: Mean morning PEF||34.8|22.7|<0.001
91544896|NCT02554786|182968586|SUPERIORITY||LS Mean|30.2|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|24.2|36.3|||LMM|||Week 52: Mean morning PEF||36.3|24.2|<0.001
91544897|NCT02554786|182968586|SUPERIORITY||LS Mean|13.8|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|7.7|19.8|||LMM|||Week 52: Mean morning PEF||19.8|7.7|<0.001
91544898|NCT02554786|182968586|SUPERIORITY||LS Mean|23.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|18.0|29.5|||LMM|||Week 52: Mean evening PEF||29.5|18.0|<0.001
91544899|NCT02554786|182968586|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|23.3|34.8|||LMM|||Week 52: Mean evening PEF||34.8|23.3|<0.001
91544900|NCT02554786|182968586|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.95||0.002|TWO_SIDED|95.0|3.3|14.9|||LMM|||Week 52: Mean evening PEF||14.9|3.3|0.002
91544901|NCT02554786|182968587|SUPERIORITY||Odds Ratio (OR)|1.31||||0.094|TWO_SIDED|95.0|0.95|1.81|||Logistic regression model|||Day 183||1.81|0.95|0.094
91544902|NCT02554786|182968587|SUPERIORITY||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.26|2.37|||Logistic regression model|||Day 183||2.37|1.26|<0.001
91765197|NCT02123849|183419319|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
91544903|NCT02554786|182968587|SUPERIORITY||Odds Ratio (OR)|1.06||||0.746|TWO_SIDED|95.0|0.76|1.46|||Logistic regression model|||Day 183||1.46|0.76|0.746
91544904|NCT02554786|182968587|SUPERIORITY||Odds Ratio (OR)|1.34||||0.088|TWO_SIDED|95.0|0.96|1.87|||Logistic regression model|||Day 364||1.87|0.96|0.088
91544905|NCT02554786|182968587|SUPERIORITY||Odds Ratio (OR)|2.24|||<|0.001|TWO_SIDED|95.0|1.58|3.17|||Logistic regression model|||Day 364||3.17|1.58|<0.001
91544906|NCT02554786|182968587|SUPERIORITY||Odds Ratio (OR)|1.05||||0.771|TWO_SIDED|95.0|0.75|1.49|||Logistic regression model|||Day 364||1.49|0.75|0.771
91544907|NCT02554786|182968588|SUPERIORITY||LS Mean|5.8|STANDARD_ERROR_OF_MEAN|2.29||0.012|TWO_SIDED|95.0|1.3|10.2|||Linear Mixed Model (LMM)|||||10.2|1.3|0.012
91544908|NCT02554786|182968588|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|4.6|13.6|||LMM|||||13.6|4.6|<0.001
91544909|NCT02554786|182968588|SUPERIORITY||LS Mean|3.4|STANDARD_ERROR_OF_MEAN|2.29||0.135|TWO_SIDED|95.0|-1.1|7.9|||LMM|||||7.9|-1.1|0.135
91544910|NCT02554786|182968589|SUPERIORITY||LS Mean|5.0|STANDARD_ERROR_OF_MEAN|2.25||0.026|TWO_SIDED|95.0|0.6|9.4|||LMM|||||9.4|0.6|0.026
91544911|NCT02554786|182968589|SUPERIORITY||LS Mean|8.1|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|3.7|12.5|||LMM|||||12.5|3.7|<0.001
91544912|NCT02554786|182968589|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|2.25||0.151|TWO_SIDED|95.0|-1.2|7.7|||LMM|||||7.7|-1.2|0.151
91544913|NCT02554786|182968590|SUPERIORITY||LS Mean|2.8|STANDARD_ERROR_OF_MEAN|1.72||0.104|TWO_SIDED|95.0|-0.6|6.2|||LMM|||||6.2|-0.6|0.104
91544914|NCT02554786|182968590|SUPERIORITY||LS Mean|3.9|STANDARD_ERROR_OF_MEAN|1.72||0.024|TWO_SIDED|95.0|0.5|7.3|||LMM|||||7.3|0.5|0.024
91544915|NCT02554786|182968590|SUPERIORITY||LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.73||0.588|TWO_SIDED|95.0|-2.5|4.3|||LMM|||||4.3|-2.5|0.588
91544916|NCT02554786|182968591|SUPERIORITY||LS Mean|6.4|STANDARD_ERROR_OF_MEAN|2.19||0.003|TWO_SIDED|95.0|2.1|10.7|||LMM|||||10.7|2.1|0.003
91544917|NCT02554786|182968591|SUPERIORITY||LS Mean|8.9|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|4.6|13.2|||LMM|||||13.2|4.6|<0.001
91544918|NCT02554786|182968591|SUPERIORITY||LS Mean|4.8|STANDARD_ERROR_OF_MEAN|2.2||0.029|TWO_SIDED|95.0|0.5|9.1|||LMM|||||9.1|0.5|0.029
91544919|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.039||0.001|TWO_SIDED|95.0|-0.2|-0.05|||LMM|||Week1-26 Mean night-time number of puffs||-0.05|-0.2|0.001
91544920|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.035|TWO_SIDED|95.0|-0.16|-0.01|||LMM|||Week 1-26 Mean night-time number of puffs||-0.01|-0.16|0.035
91544921|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.039||0.261|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-26 Mean night-time number of puffs||0.03|-0.12|0.261
91544922|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0|-0.28|-0.09|||LMM|||Week 1-26 Mean daytime number of puffs||-0.09|-0.28|<0.001
91544923|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.047||0.011|TWO_SIDED|95.0|-0.21|-0.03|||LMM|||Week 1-26 Mean daytime number of puffs||-0.03|-0.21|0.011
91544924|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.04|STANDARD_DEVIATION|0.047||0.425|TWO_SIDED|95.0|-0.13|0.06|||LMM|||Week 1-26 Mean daytime number of puffs||0.06|-0.13|0.425
91544925|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.46|-0.15|||LMM|||Week 1-26 Mean daily number of puffs||-0.15|-0.46|<0.001
91544926|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.081||0.017|TWO_SIDED|95.0|-0.35|-0.03|||LMM|||Week 1-26 Mean daily number of puffs||-0.03|-0.35|0.017
91765198|NCT02123849|183419320|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.06|||||||t-test, 1 sided|||||||0.06
91544927|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.29|TWO_SIDED|95.0|-0.24|-0.07|||LMM|||Week 1-26 Mean daily number of puffs||-0.07|-0.24|0.29
91544928|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|95.0|-0.19|-0.04|||LMM|||Week 1-52 Mean night-time number of puffs||-0.04|-0.19|0.004
91544929|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.019|TWO_SIDED|95.0|-0.17|-0.02|||LMM|||Week 1-52 Mean night-time number of puffs||-0.02|-0.17|0.019
91544930|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.039||0.226|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-52 Mean night-time number of puffs||0.03|-0.12|0.226
91544931|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07|||LMM|||Week 1-52 Mean daytime number of puffs||-0.07|-0.26|<0.001
91544932|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.048||0.002|TWO_SIDED|95.0|-0.24|-0.05|||LMM|||Week 1-52 Mean daytime number of puffs||-0.05|-0.24|0.002
91544933|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.384|TWO_SIDED|95.0|-0.14|0.05|||LMM|||Week 1-52 Mean daytime number of puffs||0.05|-0.14|0.384
91544934|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.44|-0.12|||LMM|||Week 1-52 Mean daily number of puffs||-0.12|-0.44|< 0.001
91544935|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.23|STANDARD_ERROR_OF_MEAN|0.081||0.004|TWO_SIDED|95.0|-0.39|-0.07|||LMM|||Week 1-52 Mean daily number of puffs||-0.07|-0.39|0.004
91544936|NCT02554786|182968592|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.245|TWO_SIDED|95.0|-0.25|0.06|||LMM|||Week 1-52 Mean daily number of puffs||0.06|-0.25|0.245
91544937|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.72|||Regression, Cox|||Moderate or severe asthma exacerbation||0.72|0.39|<0.001
91544938|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6|||Regression, Cox|||Moderate or severe asthma exacerbation||0.6|0.34|<0.001
91765199|NCT01717872|183419323|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||MAC blade lifting the tongue versus Miller blade lifting the epiglottis||||>0.05
91544939|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.209|TWO_SIDED|95.0|0.59|1.12|||Regression, Cox|||Moderate or severe asthma exacerbation||1.12|0.59|0.209
91544940|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.003|TWO_SIDED|95.0|0.36|0.81|||Regression, Cox|||Severe asthma exacerbation||0.81|0.36|0.003
91544941|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.3|0.63|||Regression, Cox|||Severe asthma exacerbation||0.63|0.3|<0.001
91544942|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.115|TWO_SIDED|95.0|0.47|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.47|0.115
91544943|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.82|||Regression, Cox|||All asthma exacerbation||0.82|0.51|<0.001
91544944|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.38|0.6|||Regression, Cox|||All asthma exacerbation||0.6|0.38|<0.001
91544945|NCT02554786|182968593|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.185|TWO_SIDED|95.0|0.66|1.08|||Regression, Cox|||All asthma exacerbation||1.08|0.66|0.185
91544946|NCT02554786|182968594|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.337|TWO_SIDED|95.0|0.13|2.03|||Regression, Cox|||||2.03|0.13|0.337
91544947|NCT02554786|182968594|SUPERIORITY||Hazard Ratio (HR)|0.14||||0.063|TWO_SIDED|95.0|0.02|1.11|||Regression, Cox|||||1.11|0.02|0.063
91544948|NCT02554786|182968594|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.599|TWO_SIDED|95.0|0.27|9.7|||Regression, Cox|||||9.7|0.27|0.599
91544949|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.65||||0.008|TWO_SIDED|95.0|0.48|0.89|||Generalized linear model|||Moderate or severe asthma exacerbation||0.89|0.48|0.008
91544950|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64|||Generalized linear model|||Moderate or severe asthma exacerbation||0.64|0.35|<0.001
91544951|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.93||||0.669|TWO_SIDED|95.0|0.67|1.29|||Generalized linear model|||Moderate or severe asthma exacerbation||1.29|0.67|0.669
91544952|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.71||||0.108|TWO_SIDED|95.0|0.47|1.08|||Generalized linear model|||Severe asthma exacerbation||1.08|0.47|0.108
91544953|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.67|||Generalized linear model|||Severe asthma exacerbation||0.67|0.31|<0.001
91544954|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.89||||0.597|TWO_SIDED|95.0|0.58|1.37|||Generalized linear model|||Severe asthma exacerbation||1.37|0.58|0.597
91544955|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.87|0.52|0.002
91544956|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.59|0.36|<0.001
91544957|NCT02554786|182968595|SUPERIORITY||Rate Ratio|0.95||||0.681|TWO_SIDED|95.0|0.72|1.23|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.23|0.72|0.681
91544958|NCT02554786|182968596|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
91544959|NCT02554786|182968596|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
91544960|NCT02554786|182968596|SUPERIORITY|||||||0.059|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.059
91544961|NCT02554786|182968596|SUPERIORITY|||||||0.004|||||||Van Elteren Test|||Severe Asthma Exacerbation||||0.004
91544962|NCT02554786|182968596|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||Severe Asthma Exacerbation||||<0.001
91544963|NCT02554786|182968596|SUPERIORITY|||||||0.025|||||||van Elteren test|||Severe asthma exacerbation||||0.025
91544964|NCT02554786|182968596|SUPERIORITY|||||||0.002|||||||Van Elteren Test|||All(mild, moderate, severe) Asthma Exacerbation||||0.002
91765200|NCT01717872|183419324|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91765201|NCT01717872|183419325|SUPERIORITY_OR_OTHER||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<0.0004
91765202|NCT03187119|183419331|SUPERIORITY||Slope|1.41||||0.42|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|linear mixed model|||The reference group for this model is the Pictorial Asthma Action Plan Group.||||0.42
91544965|NCT02554786|182968596|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||All (mild, moderate, severe) Asthma Exacerbation||||<0.001
91544966|NCT02554786|182968596|SUPERIORITY|||||||0.074|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.074
91544967|NCT02554786|182968598|SUPERIORITY||Hazard Ratio (HR)|0.26||||0.222|TWO_SIDED|95.0|0.03|2.29|||Regression, Cox|||||2.29|0.03|0.222
91544968|NCT02554786|182968598|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.992|TWO_SIDED|95.0|0.0||The upper limit of CI could not be calculated due to low number of participants with asthma exacerbation.||Regression, Cox||||||0|0.992
91544969|NCT02554786|182968598|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.618|TWO_SIDED|95.0|0.05|6.01|||Regression, Cox|||||6.01|0.05|0.618
91544970|NCT02554786|182968601|SUPERIORITY||LS Mean|10.1|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|6.2|14.1|||LMM|||Weeks 1-26||14.1|6.2|< 0.001
91544971|NCT02554786|182968601|SUPERIORITY||LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|4.3|12.3|||LMM|||Weeks 1-26||12.3|4.3|<0.001
91544972|NCT02554786|182968601|SUPERIORITY||LS Mean|4.1|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|95.0|0.1|8.0|||LMM|||Weeks 1-26||8|0.1|0.045
91544973|NCT02554786|182968601|SUPERIORITY||LS Mean|9.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|5.7|13.6|||LMM|||Weeks 1-52||13.6|5.7|<0.001
91544974|NCT02554786|182968601|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|4.7|12.6|||LMM|||Weeks 1-52||12.6|4.7|<0.001
91544975|NCT02554786|182968601|SUPERIORITY||LS Mean|4.3|STANDARD_ERROR_OF_MEAN|2.04||0.034|TWO_SIDED|95.0|0.3|8.3|||LMM|||Weeks 1-52||8.3|0.3|0.034
91544976|NCT02554786|182968602|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0462||0.002|TWO_SIDED|95.0|0.056|0.237|||MMRM|||Day 30||0.237|0.056|0.002
91544977|NCT02554786|182968602|SUPERIORITY||LS Mean|0.123|STANDARD_ERROR_OF_MEAN|0.0464||0.008|TWO_SIDED|95.0|0.032|0.214|||MMRM|||Day 30||0.214|0.032|0.008
91544978|NCT02554786|182968602|SUPERIORITY||LS Mean|0.045|STANDARD_ERROR_OF_MEAN|0.046||0.33|TWO_SIDED|95.0|-0.045|0.135|||MMRM|||Day 30||0.135|-0.045|0.33
91544979|NCT02554786|182968602|SUPERIORITY||LS Mean|0.054|STANDARD_ERROR_OF_MEAN|0.0503||0.28|TWO_SIDED|95.0|-0.044|0.153|||MMRM|||Day 86||0.153|-0.044|0.28
91544980|NCT02554786|182968602|SUPERIORITY||LS Mean|0.118|STANDARD_ERROR_OF_MEAN|0.0507||0.02|TWO_SIDED|95.0|0.019|0.217|||MMRM|||Day 86||0.217|0.019|0.02
91544981|NCT02554786|182968602|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0501||0.598|TWO_SIDED|95.0|-0.072|0.125|||MMRM|||Day 86||0.125|-0.072|0.598
91544982|NCT02554786|182968602|SUPERIORITY||LS Mean|0.127|STANDARD_ERROR_OF_MEAN|0.0526||0.016|TWO_SIDED|95.0|0.023|0.23|||MMRM|||Day 183||0.23|0.023|0.016
91544983|NCT02554786|182968602|SUPERIORITY||LS Mean|0.156|STANDARD_ERROR_OF_MEAN|0.0529||0.003|TWO_SIDED|95.0|0.053|0.26|||MMRM|||Day 183||0.26|0.053|0.003
91544984|NCT02554786|182968602|SUPERIORITY||LS Mean|0.085|STANDARD_ERROR_OF_MEAN|0.0525||0.103|TWO_SIDED|95.0|-0.017|0.188|||MMRM|||Day 183||0.188|-0.017|0.103
91544985|NCT02554786|182968602|SUPERIORITY||LS Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0542||0.188|TWO_SIDED|95.0|-0.035|0.178|||MMRM|||Day 254||0.178|-0.035|0.188
91544986|NCT02554786|182968602|SUPERIORITY||LS Mean|0.168|STANDARD_ERROR_OF_MEAN|0.0543||0.002|TWO_SIDED|95.0|0.061|0.274|||MMRM|||Day 254||0.274|0.061|0.002
91544987|NCT02554786|182968602|SUPERIORITY||LS Mean|0.061|STANDARD_ERROR_OF_MEAN|0.0538||0.258|TWO_SIDED|95.0|-0.045|0.166|||MMRM|||Day 254||0.166|-0.045|0.258
91544988|NCT02554786|182968602|SUPERIORITY||LS Mean|0.079|STANDARD_ERROR_OF_MEAN|0.0552||0.154|TWO_SIDED|95.0|-0.03|0.187|||MMRM|||Day 364||0.187|-0.030|0.154
91544989|NCT02554786|182968602|SUPERIORITY||LS Mean|0.191|STANDARD_ERROR_OF_MEAN|0.0553|<|0.001|TWO_SIDED|95.0|0.082|0.299|||MMRM|||Day 364||0.299|0.082|<0.001
91544990|NCT02554786|182968602|SUPERIORITY||LS Mean|0.041|STANDARD_ERROR_OF_MEAN|0.0548||0.455|TWO_SIDED|95.0|-0.067|0.148|||MMRM|||Day 364||0.148|-0.067|0.455
91544991|NCT02554786|182968603|NON_INFERIORITY|QMF 150/320 was considered non-inferior to S/F 50/500 if the lower bound of the 95% CI was above the non-inferiority margin of -90 mL and was considered superior if the lower bound of the 95% CI was \> 0. The p-value is for null-hypothesis testing.|LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0222||0.101|TWO_SIDED|95.0|-0.007|0.08|||MMRM|||||0.080|-0.007|0.101
91544992|NCT01828554|182968606|OTHER|||||||0.4882||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||The null hypothesis that the AUC from cycle 1 day 1 (based on ideal body weight) is equal to the AUC from cycle 1 day 9 (based on actual body weight) was tested against the alternative hypothesis that the AUCs are not equal. A linear mixed effect model with patient specific random effects was conducted||||0.4882
91544993|NCT01828554|182968607|OTHER|||||||0.7497||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||||||0.7497
91544994|NCT04583423|182968611|OTHER||Difference in Percentages|10.4||||0.3504|TWO_SIDED|95.0|-13.4|35.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50-mg MK-3655 minus % placebo|||35.1|-13.4|0.3504
91544995|NCT04583423|182968611|OTHER||Difference in Percentages|9.2||||0.373|TWO_SIDED|95.0|-15.6|32.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100-mg MK-3655 minus % placebo|||32.1|-15.6|0.3730
91544996|NCT04583423|182968611|OTHER||Difference in Percentages|15.4||||0.1428|TWO_SIDED|95.0|-8.5|42.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300-mg MK-3655 minus % placebo|||42.3|-8.5|0.1428
91544997|NCT04583423|182968614|OTHER||Difference in Least Square (LS) Means|19.1|||||TWO_SIDED|95.0|1.7|36.4|||||Difference=LS Mean 50 mg minus LS Mean Placebo|||36.4|1.7|
91544998|NCT04583423|182968614|OTHER||Difference in LS Means|19.0|||||TWO_SIDED|95.0|2.2|35.8|||||Difference=LS Mean 100 mg minus LS Mean Placebo|||35.8|2.2|
91544999|NCT04583423|182968614|OTHER||Difference in LS Means|26.1|||||TWO_SIDED|95.0|9.5|42.8|||||Difference=LS Mean 300 mg minus LS Mean Placebo|||42.8|9.5|
91545000|NCT04583423|182968615|OTHER||Difference in Percentages|1.6||||0.8978|TWO_SIDED|95.0|-26.5|30.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||30.3|-26.5|0.8978
91765203|NCT03187119|183419331|SUPERIORITY||Slope|-14.31||||0.03|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
91765204|NCT03187119|183419331|SUPERIORITY||Slope|-0.33||||0.89|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.89
91545001|NCT04583423|182968615|OTHER||Difference in Parentages|20.0||||0.1869|TWO_SIDED|95.0|-10.6|46.4|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||46.4|-10.6|0.1869
91545002|NCT04583423|182968615|OTHER||Difference in Percentages|8.5||||0.5636|TWO_SIDED|95.0|-22.1|38.5|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300 mg minus % Placebo|||38.5|-22.1|0.5636
91545003|NCT04583423|182968616|OTHER||Difference in Percentages|1.6||||0.9174|TWO_SIDED|95.0|-28.6|32.6|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||32.6|-28.6|0.9174
91545004|NCT04583423|182968616|OTHER||Difference in Percentages|18.5||||0.272|TWO_SIDED|95.0|-14.5|47.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||47.1|-14.5|0.2720
91545005|NCT04583423|182968616|OTHER||Difference in Percentages|5.3||||0.7586|TWO_SIDED|95.0|-26.7|37.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference= % 300 mg minus % Placebo|||37.3|-26.7|0.7586
91545006|NCT02214550|182968624|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.69||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.02
91545007|NCT02214550|182968624|SUPERIORITY||Slope|-1.4597|STANDARD_ERROR_OF_MEAN|0.8245||0.08|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.08
91545008|NCT02214550|182968624|SUPERIORITY||Slope|1.9186|STANDARD_ERROR_OF_MEAN|0.8121||0.023|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates a time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.023
91765205|NCT03187119|183419332|SUPERIORITY||Slope|-1.59||||0.31|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.31
91545009|NCT02214550|182968625|SUPERIORITY||Slope|0.3716|STANDARD_ERROR_OF_MEAN|0.3056||0.2315|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time\*group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.2315
91765206|NCT03187119|183419332|SUPERIORITY||Slope|1.9||||0.73|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.73
91765207|NCT03187119|183419332|SUPERIORITY||Slope|-0.21||||0.92|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.92
91765208|NCT03187119|183419333|SUPERIORITY||Slope|0.52||||0.06|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.06
91765209|NCT03187119|183419333|SUPERIORITY||Slope|-1.57||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
91545010|NCT02214550|182968625|SUPERIORITY||Slope|0.2703|STANDARD_ERROR_OF_MEAN|0.3244||0.4097|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.4097
91545011|NCT02214550|182968625|SUPERIORITY||Slope|-0.1574|STANDARD_ERROR_OF_MEAN|0.3283||0.6341|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (continuous microgestin: D+COS-vs. PBS) interaction.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.6341
91545012|NCT02214550|182968626|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.1||0.393|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The OCP vs No OCP contrast was estimated here:||||.393
91545013|NCT02214550|182968626|SUPERIORITY||Slope|0.007|STANDARD_ERROR_OF_MEAN|0.09||0.941|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameters reported indicates time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The cyclic vs. continuous microgestin contrast was run here||||0.941
91545014|NCT02214550|182968626|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The PBS-continuous microgestin vs. D+COS-continuous microgestin contrast was evaluated here||||0.005
91545015|NCT01736215|182968628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.343||||0.266|TWO_SIDED|95.0|0.052|2.261||The binary logistic regression analysis was performed using a crude model between predictor variable endogenous EPO (EPO less than or equal to 45.2 and EPO greater than 45.3)|Regression, Logistic|||||2.261|0.052|0.266
91545016|NCT01736215|182968629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.125||||0.05|TWO_SIDED|95.0|0.016|0.999||The binary logistic regression analysis was performed using a crude model between predictor variable CRP (CRP less than or equal to 10.3 and CRP greater than 10.4)|Regression, Logistic|||||0.999|0.016|0.05
91545017|NCT03447249|182968658|SUPERIORITY||Least Squares (LS) Mean Difference|14.0|||<|0.0001|TWO_SIDED|95.0|12.4|15.7|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.7|12.4|<0.0001
91545018|NCT03447249|182968659|SUPERIORITY||LS Mean Difference|14.2|||<|0.0001|TWO_SIDED|95.0|12.6|15.7|||Mixed-effects model for repeated measure|||||15.7|12.6|<0.0001
91545019|NCT03447249|182968660|SUPERIORITY||Rate ratio|0.14|||<|0.0001|TWO_SIDED|95.0|0.09|0.24|||Negative binomial regression model|||||0.24|0.09|<0.0001
91545020|NCT03447249|182968661|SUPERIORITY||LS Mean Difference|-44.6|||<|0.0001|TWO_SIDED|95.0|-47.2|-41.9|||Mixed-effects model for repeated measure|||||-41.9|-47.2|<0.0001
91545021|NCT03447249|182968662|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|17.2|23.0|||Mixed-effects model for repeated measure|||||23.0|17.2|<0.0001
91545022|NCT03447249|182968663|SUPERIORITY||LS Mean Difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.91|1.31|||Mixed-effects model for repeated measure|||||1.31|0.91|<0.0001
91545023|NCT03447249|182968664|SUPERIORITY||LS Mean Difference|-43.4|||<|0.0001|TWO_SIDED|95.0|-46.3|-40.5|||Mixed-effects model for repeated measure|||||-40.5|-46.3|<0.0001
91545024|NCT03447249|182968665|SUPERIORITY||LS Mean Difference|17.9|||<|0.0001|TWO_SIDED|95.0|14.5|21.3|||Mixed-effects model for repeated measure|||||21.3|14.5|<0.0001
91545025|NCT03447249|182968667|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|95.0|0.24|0.54||||||||0.54|0.24|
91545026|NCT03447249|182968668|SUPERIORITY||LS Mean Difference|3.2|||||TWO_SIDED|95.0|2.7|3.8||||||||3.8|2.7|
91545027|NCT02376790|182968680|SUPERIORITY||Treatment Difference|13.9||||0.005|TWO_SIDED|95.0|5.8|22.0||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||22.0|5.8|0.005
91765210|NCT03187119|183419333|SUPERIORITY||Slope|0.37||||0.33|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.33
91545028|NCT02376790|182968680|SUPERIORITY||Treatment Difference|9.2||||0.029|TWO_SIDED|95.0|1.0|17.3||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||17.3|1.0|0.029
91545029|NCT02376790|182968681|SUPERIORITY||Treatment Difference|12.2||||0.005|TWO_SIDED|95.0|4.9|19.6||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||19.6|4.9|0.005
91545030|NCT02376790|182968681|SUPERIORITY||Treatment Difference|11.6||||0.005|TWO_SIDED|95.0|4.2|18.9||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||18.9|4.2|0.005
91545031|NCT02376790|182968683|SUPERIORITY||Treatment Difference|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||23.0|6.4|<0.001
91545032|NCT02376790|182968683|SUPERIORITY||Treatment Difference|11.8||||0.006|TWO_SIDED|95.0|3.4|20.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||20.2|3.4|0.006
91545033|NCT02376790|182968684|SUPERIORITY||Treatment Difference|13.4|||<|0.001|TWO_SIDED|95.0|6.5|20.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.4|6.5|<0.001
91545034|NCT02376790|182968684|SUPERIORITY||Treatment Difference|13.7|||<|0.001|TWO_SIDED|95.0|6.7|20.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.7|6.7|<0.001
91545035|NCT02376790|182968693|SUPERIORITY||LS Mean Treatment Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.34||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.91|<0.001
91545036|NCT02376790|182968693|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.92|-0.34||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.92|<0.001
91545037|NCT02376790|182968694|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.18||0.59|TWO_SIDED|95.0|-2.93|1.68||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||1.68|-2.93|0.59
91545038|NCT02376790|182968694|SUPERIORITY||LS Mean Treatment Difference|-1.32|STANDARD_ERROR_OF_MEAN|1.18||0.26|TWO_SIDED|95.0|-3.63|0.99||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||0.99|-3.63|0.26
91545039|NCT02376790|182968695|SUPERIORITY||LS Mean Treatment Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.2||0.41|TWO_SIDED|95.0|-3.35|1.38||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||1.38|-3.35|0.41
91545040|NCT02376790|182968695|SUPERIORITY||LS Mean Treatment Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.21||0.15|TWO_SIDED|95.0|-4.09|0.65||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||0.65|-4.09|0.15
91545041|NCT02376790|182968696|SUPERIORITY||LS Mean Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED|95.0|-0.52|-0.07||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.07|-0.52|0.010
91545042|NCT02376790|182968696|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.62|-0.17||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.17|-0.62|<0.001
91545043|NCT02376790|182968697|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.34|TWO_SIDED|95.0|-0.15|0.05||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.05|-0.15|0.34
91545044|NCT02376790|182968697|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.67|TWO_SIDED|95.0|-0.12|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.12|0.67
91545045|NCT02376790|182968698|SUPERIORITY||LS Mean Treatment Difference|1.94|STANDARD_ERROR_OF_MEAN|0.8||0.015|TWO_SIDED|95.0|0.37|3.51||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.51|0.37|0.015
91545046|NCT02376790|182968698|SUPERIORITY||LS Mean Treatment Difference|1.71|STANDARD_ERROR_OF_MEAN|0.8||0.033|TWO_SIDED|95.0|0.13|3.28||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.28|0.13|0.033
91545047|NCT02376790|182968698|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.84||0.97|TWO_SIDED|95.0|-1.69|1.63||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.63|-1.69|0.97
91545048|NCT02376790|182968698|SUPERIORITY||LS Mean Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.85||0.56|TWO_SIDED|95.0|-2.16|1.16||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.16|-2.16|0.56
91545049|NCT02376790|182968699|SUPERIORITY||LS Mean Treatment Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|-1.03|-0.09||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||-0.09|-1.03|0.020
91545050|NCT02376790|182968699|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1|TWO_SIDED|95.0|-0.88|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.88|0.10
91545051|NCT02376790|182968701|SUPERIORITY||LS Mean Treatment Difference|13.92|STANDARD_ERROR_OF_MEAN|33.23||0.68|TWO_SIDED|95.0|-51.52|79.36||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||79.36|-51.52|0.68
91545052|NCT02376790|182968701|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|33.05||0.85|TWO_SIDED|95.0|-58.75|71.42||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||71.42|-58.75|0.85
91545053|NCT02376790|182968702|SUPERIORITY||Treatment Difference|12.9||||0.057|TWO_SIDED|95.0|-0.4|26.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||26.2|-0.4|0.057
91545054|NCT02376790|182968702|SUPERIORITY||Treatment Difference|10.9||||0.12|TWO_SIDED|95.0|-2.5|24.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||24.4|-2.5|0.12
91545055|NCT02376790|182968703|SUPERIORITY||LS Mean Treatment Difference|0.16|STANDARD_ERROR_OF_MEAN|0.42||0.7|TWO_SIDED|95.0|-0.66|0.98||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.98|-0.66|0.70
91765211|NCT03187119|183419334|SUPERIORITY||Slope|-0.01||||0.002|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2-3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.002
91765212|NCT03187119|183419334|SUPERIORITY||Slope|-0.16||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
91545056|NCT02376790|182968703|SUPERIORITY||LS Mean Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.42||0.93|TWO_SIDED|95.0|-0.79|0.86||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.86|-0.79|0.93
91545057|NCT02376790|182968704|SUPERIORITY||Treatment Difference|3.2||||0.55|TWO_SIDED|95.0|-7.3|13.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||13.7|-7.3|0.55
91545058|NCT02376790|182968704|SUPERIORITY||Treatment Difference|8.8||||0.11|TWO_SIDED|95.0|-1.9|19.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||19.4|-1.9|0.11
91545059|NCT02376790|182968705|SUPERIORITY||LS Mean Treatment Difference|9.36|STANDARD_ERROR_OF_MEAN|4.33||0.031|TWO_SIDED|95.0|0.85|17.87||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||17.87|0.85|0.031
91545060|NCT02376790|182968705|SUPERIORITY||LS Mean Treatment Difference|3.02|STANDARD_ERROR_OF_MEAN|4.33||0.49|TWO_SIDED|95.0|-5.49|11.54||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||11.54|-5.49|0.49
91545061|NCT02376790|182968706|SUPERIORITY||LS Mean Treatment Difference|15.95|STANDARD_ERROR_OF_MEAN|4.55|<|0.001|TWO_SIDED|95.0|6.99|24.9||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||24.90|6.99|<0.001
91545062|NCT02376790|182968706|SUPERIORITY||LS Mean Treatment Difference|6.97|STANDARD_ERROR_OF_MEAN|4.5||0.12|TWO_SIDED|95.0|-1.89|15.83||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||15.83|-1.89|0.12
91545063|NCT02376790|182968711|SUPERIORITY||Treatment Difference|11.4||||0.019|TWO_SIDED|95.0|2.0|20.8||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||20.8|2.0|0.019
91545064|NCT02376790|182968711|SUPERIORITY||Treatment Difference|4.2||||0.4|TWO_SIDED|95.0|-5.6|14.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||14.0|-5.6|0.40
91545065|NCT02376790|182968712|SUPERIORITY||Treatment Difference|20.1||||0.004|TWO_SIDED|95.0|6.8|33.3||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||33.3|6.8|0.004
91545066|NCT02376790|182968712|SUPERIORITY||Treatment Difference|17.1||||0.012|TWO_SIDED|95.0|4.0|30.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||30.2|4.0|0.012
91765213|NCT03187119|183419334|SUPERIORITY||Slope|0.43||||0.69|TWO_SIDED|||||The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.69
91545067|NCT02238483|182968717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.2371|TWO_SIDED|95.0|0.81|2.4|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.||2.40|0.81|0.2371
91545068|NCT02238483|182968718|SUPERIORITY_OR_OTHER||Rate Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.33||0.249|TWO_SIDED|95.0|0.82|2.16|||regression, negative binomial||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.16|0.82|0.249
91545069|NCT02238483|182968719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.1261|TWO_SIDED|95.0|0.89|2.5|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.50|0.89|0.1261
91545070|NCT02238483|182968720|SUPERIORITY_OR_OTHER||Rate ratio|1.4|STANDARD_ERROR_OF_MEAN|0.33||0.157|TWO_SIDED|95.0|0.88|2.21|||regression, negative binomial|||||2.21|0.88|0.157
91545071|NCT02238483|182968721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.1529|TWO_SIDED|95.0|0.85|2.76|||Regression, Cox|||||2.76|0.85|0.1529
91545072|NCT02238483|182968722|SUPERIORITY_OR_OTHER||rate ratio|1.5|STANDARD_ERROR_OF_MEAN|0.4||0.129|TWO_SIDED|95.0|0.89|2.52|||regression, negative binomial|||||2.52|0.89|0.129
91545073|NCT02238483|182968723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.8543|TWO_SIDED|95.0|0.43|2.01|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.01|0.43|0.8543
91545074|NCT02238483|182968724|SUPERIORITY_OR_OTHER||rate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.41||0.751|TWO_SIDED|95.0|0.55|2.29|||regression, negative binomial|||||2.29|0.55|0.751
91545075|NCT02238483|182968725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.5381|TWO_SIDED|95.0|0.54|1.38|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||1.38|0.54|0.5381
91545076|NCT02238483|182968726|SUPERIORITY_OR_OTHER||rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|0.55|1.3|||regression, negative binomial|||||1.30|0.55|0.440
91545077|NCT02238483|182968727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.5474|TWO_SIDED|95.0|-1.6|0.85|||Mixed Models Analysis||LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.85|-1.60|0.5474
91545078|NCT02238483|182968728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.6352|TWO_SIDED|95.0|-2.62|4.29|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||4.29|-2.62|0.6352
91545079|NCT02238483|182968729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2694|TWO_SIDED|95.0|-0.34|0.1|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.10|-0.34|0.2694
91545080|NCT02238483|182968730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.5144|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.07|-0.03|0.5144
91545081|NCT02238483|182968731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.5416|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.05|-0.10|0.5416
91545082|NCT02238483|182968732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.1965|TWO_SIDED|95.0|0.0|0.02|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.02|0.00|0.1965
91545083|NCT02538341|182968733|OTHER|||||||0.0023||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p value,from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.0023
91545084|NCT02538341|182968734|OTHER|||||||0.31||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.31
91545085|NCT01803555|182968747|NON_INFERIORITY|The noninferiority of BF Spiromax to Symbicort Turbohaler was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -15 L/min.|Least Square (LS) mean difference|-2.957||||0.3387|TWO_SIDED|95.0|-9.02|3.11|||Mixed Models Analysis|Analysis included effects due to baseline weekly average of daily trough AM PEF, gender, age, treatment, time, and treatment-by-time interaction.||||3.11|-9.02|0.3387
91545086|NCT00393484|182968752|NON_INFERIORITY_OR_EQUIVALENCE|The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero.|Difference in proportion|25.67||||0.0006|TWO_SIDED|90.0|14.48|36.86||There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established.|Chi-squared|||A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir.||36.86|14.48|0.0006
91545087|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|24.55||||0.0003|TWO_SIDED|90.0|14.45|34.66||Treatment comparisons were assessed using the same method used in the primary endpoint.|Chi-squared|||HBV DNA \<10\^3 copies/mL at 24 Weeks||34.66|14.45|0.0003
91545088|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|13.62||||0.0167|TWO_SIDED|90.0|4.85|22.38||Treatment comparisons were assessed using the same method as the primary endpoint.|Chi-squared|||HBV DNA \<10\^4 copies/mL at 24 Weeks||22.38|4.85|0.0167
91545089|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24||||0.4467|TWO_SIDED|90.0|-2.62|11.1|||Chi-squared|||HBV DNA \<10\^5 at 24 Weeks||11.10|-2.62|0.4467
91545090|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|26.12||||0.0002|TWO_SIDED|90.0|15.87|36.36|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 48 Weeks||36.36|15.87|0.0002
91545091|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|20.09||||0.0009|TWO_SIDED|90.0|11.1|29.07|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 48 Weeks||29.07|11.10|0.0009
91545092|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|16.96||||0.0029|TWO_SIDED|90.0|8.43|25.5|||Chi-squared|||HBV DNA \<10\^5 at 48 Weeks||25.50|8.43|0.0029
91545093|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|35.27|||<|0.0001|TWO_SIDED|90.0|24.02|46.51|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 96 Weeks||46.51|24.02|<0.0001
91545094|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|29.02|||<|0.0001|TWO_SIDED|90.0|18.07|39.97|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 96 Weeks||39.97|18.07|<0.0001
91545095|NCT00393484|182968753|SUPERIORITY_OR_OTHER||Difference|24.33||||0.0006|TWO_SIDED|90.0|13.71|34.95|||Chi-squared|||HBV DNA \<10\^5 copies/mL at 96 Weeks||34.95|13.71|0.0006
91545096|NCT00393484|182968754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariates of treatment and baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from baseline were based on patients with measurements at both Baseline and Week 24.||||<0.0001
91545097|NCT00393484|182968754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 48.||||<0.0001
91545098|NCT00393484|182968754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at 96 Weeks.||||<0.0001
91545099|NCT00393484|182968754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 144.||||<0.0001
91545100|NCT00393484|182968754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 192.||||<0.0001
91545101|NCT00393484|182968754|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 240.||||<0.0001
91765214|NCT03187119|183419334|SUPERIORITY||Slope|0.02||||0.37|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.37
91765215|NCT03187119|183419334|SUPERIORITY||Slope|-1.14||||0.12|TWO_SIDED|||||The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.12
91765216|NCT03187119|183419334|SUPERIORITY||Slope|0.01||||0.006|TWO_SIDED|||||The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference groups for this analysis is the 2x per day group.||||0.006
91545102|NCT00393484|182968756|SUPERIORITY_OR_OTHER||Difference|18.97||||0.0278|TWO_SIDED|90.0|5.22|32.73|||Chi-squared||At 24 Weeks|||32.73|5.22|0.0278
91545103|NCT00393484|182968756|SUPERIORITY_OR_OTHER||Difference|26.34||||0.0014|TWO_SIDED|90.0|13.65|39.03|||Chi-squared||At 48 Weeks|||39.03|13.65|0.0014
91545104|NCT00393484|182968756|SUPERIORITY_OR_OTHER||Difference|35.94|||<|0.0001|TWO_SIDED|90.0|23.35|48.52|||Chi-squared||At 96 Weeks|||48.52|23.35|<0.0001
91545105|NCT00393484|182968762|SUPERIORITY_OR_OTHER||Difference|33.71|||<|0.0001|TWO_SIDED|90.0|22.52|44.89|||Chi-squared||At 48 Weeks|||44.89|22.52|<0.0001
91545106|NCT00393484|182968762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.21|||<|0.0001|TWO_SIDED|90.0|34.8|57.61|||Chi-squared||At 96 Weeks|||57.61|34.80|<0.0001
91545107|NCT00393484|182968762|SUPERIORITY_OR_OTHER||Difference|33.48||||0.0003|TWO_SIDED|90.0|19.31|47.65|||Chi-squared||At 144 Weeks|||47.65|19.31|0.0003
91545108|NCT00393484|182968762|SUPERIORITY_OR_OTHER||Difference|44.64|||<|0.0001|TWO_SIDED|90.0|31.17|58.11|||Chi-squared||At 192 Weeks|||58.11|31.17|<0.0001
91545109|NCT00393484|182968762|SUPERIORITY_OR_OTHER||Difference|52.23|||<|0.0001|TWO_SIDED|90.0|39.54|64.93|||Chi-squared||At 240 Weeks|||64.93|39.54|<0.0001
91545110|NCT00393484|182968763|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Viral rebound at 96 weeks||||<0.0001
91545111|NCT03201562|182968766|SUPERIORITY||Odds Ratio (OR)|38.436||||0.0009|TWO_SIDED|90.0|6.262|235.936|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||235.936|6.262|0.0009
91765217|NCT03187119|183419334|SUPERIORITY||Slope|0.04||||0.006|TWO_SIDED|||||The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||These analyses are modeling lower adherence.|The reference group for this analysis is 2x per day group.||||0.006
91765218|NCT03187119|183419335|SUPERIORITY||Slope|0.08||||0.18|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.18
91765219|NCT03187119|183419335|SUPERIORITY||Slope|-0.09||||0.71|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.71
91765220|NCT03187119|183419335|SUPERIORITY||Slope|0.007||||0.96|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.96
91765221|NCT03187119|183419337|SUPERIORITY||Slope|-0.02||||0.74|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.74
91765222|NCT03187119|183419337|SUPERIORITY||Slope|0.02||||0.83|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.83
91765223|NCT03187119|183419337|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
91765224|NCT03187119|183419338|SUPERIORITY||Slope|0.12||||0.08|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.08
91765225|NCT03187119|183419338|SUPERIORITY||Slope|-0.12||||0.25|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.25
91545112|NCT03201562|182968766|SUPERIORITY||Odds Ratio (OR)|36.893||||0.0012|TWO_SIDED|90.0|5.936|229.31|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||229.310|5.936|0.0012
91545113|NCT03201562|182968766|SUPERIORITY||Odds Ratio (OR)|1.042||||0.9298|TWO_SIDED|90.0|0.485|2.239|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect||||2.239|0.485|0.9298
91545114|NCT02382744|182968771|SUPERIORITY_OR_OTHER||Difference between proportions (%)|10.0||||0.25|TWO_SIDED|95.0|-11.9|31.9||One-sided P-value based on the lack of plausibility that additional nerve stimulation would worsen sensory blockade rates.|Fisher Exact|||We sought to detect an increase in the rate of complete absence of sensation to pinprick 30 min following ultrasound-guided subsartorial saphenous nerve blockade to 90% from an assumed baseline of 64% as extrapolated from our previous study (cf. Head SJ et al. 2015) at β = 0.2. The required minimum sample size at α = 0.05 (one-sided) was 30 patients in each group. To be conservative, we aimed to enroll a total of 80 patients.||31.9|-11.9|0.25
91545115|NCT02382744|182968772|SUPERIORITY_OR_OTHER|||||||0.62||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.62
91545116|NCT02382744|182968773|SUPERIORITY_OR_OTHER|||||||0.62|||||||Fisher Exact|||||||0.62
91765226|NCT03187119|183419338|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
91545117|NCT02382744|182968774|SUPERIORITY_OR_OTHER|||||||0.26||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, incomplete block at 30 minutes post nerve block versus no incomplete block at 30 minutes post nerve block."||||0.26
91765227|NCT00824473|183419339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4286|STANDARD_ERROR_OF_MEAN|0.351|<|0.001||95.0|-2.12|-0.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.74|-2.12|<0.001
91765228|NCT00824473|183419340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6063|STANDARD_ERROR_OF_MEAN|0.1697|<|0.001||95.0|-0.94|-0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.27|-0.94|<0.001
91765229|NCT00824473|183419341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3947|STANDARD_ERROR_OF_MEAN|0.3391|<|0.001||95.0|-2.06|-0.73|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.73|-2.06|<0.001
91545118|NCT02382744|182968775|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.7||||0.12|TWO_SIDED|95.0|0.38|1.31|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|"To assess speed of onset, sensation to pinprick in the distribution of the saphenous nerve was assessed for each patient every 5 min until complete sensory loss was noted, or until 30 min had elapsed. To compare the two groups in speed of onset on the basis of these data, we constructed Kaplan-Meyer survival curves for the times to onset of sensory blockade and compared the underlying time-to-event data with the log-rank test."||1.31|0.38|0.12
91545119|NCT02382744|182968779|SUPERIORITY_OR_OTHER||Difference between means (s)|107.0|||<|0.0001|TWO_SIDED|95.0|61.0|153.0|||t-test, 2 sided|||||153|61|<0.0001
91765230|NCT00824473|183419342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9284|STANDARD_ERROR_OF_MEAN|0.2741|<|0.001||95.0|-1.47|-0.39|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||reflective TOSS change in baseline||-0.39|-1.47|<0.001
91765231|NCT00824473|183419343|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||change from baseline||||0.010
91545120|NCT02382744|182968782|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.58||||0.02|TWO_SIDED|95.0|0.37|0.93|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|||0.93|0.37|0.02
91545121|NCT02382744|182968785|SUPERIORITY_OR_OTHER|||||||0.0057|||||||Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two arms, Patients with response to nerve stimulation and Patients with lack response to nerve stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.0057
91545122|NCT01551355|182968812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|95.0|1.64|6.16|||t-test, 2 sided|The intervention was evaluated using generalized estimating equation models, controlling for cluster effect, sex, age, weight, and education level.||||6.16|1.64|<.001
91545123|NCT01551355|182968813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001|TWO_SIDED|95.0|2.03|6.12|||t-test, 2 sided|||||6.12|2.03|<.001
91545124|NCT01551355|182968814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36|||=|0.06|TWO_SIDED|95.0|-0.29|11.01|||t-test, 2 sided|||||11.01|-0.29|=.06
91545125|NCT03010631|182968820|SUPERIORITY||Ratio of Geometric LS Means|1.441|||||TWO_SIDED|90.0|1.166|1.782||||||||1.782|1.166|
91545126|NCT03010631|182968821|SUPERIORITY||Ratio of Geometric LS Means|2.045|||||TWO_SIDED|90.0|1.615|2.589||||||||2.589|1.615|
91545127|NCT03010631|182968822|OTHER||Ratio of Geometric LS Means|0.888|||||TWO_SIDED|90.0|0.675|1.168||||||||1.168|0.675|
91545128|NCT03010631|182968823|OTHER||Ratio of Geometric LS Means|0.413|||||TWO_SIDED|90.0|0.339|0.502||||||||0.502|0.339|
91545129|NCT01255670|182968829|OTHER|Mann-Whitney U-test and Fisher's exact test||||||0.05|||||||Fisher Exact|||||||0.05
91765232|NCT01359904|183419345|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||||||0.027
91545130|NCT01255670|182968830|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U-test and Fisher's exact test||||0.05
91765233|NCT01359904|183419346|SUPERIORITY_OR_OTHER|||||||0.67|||||||Kruskal-Wallis|||post intervention hemoglobin A1c levels||||0.67
91765234|NCT01359904|183419347|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
91765235|NCT01359904|183419348|SUPERIORITY_OR_OTHER|||||||0.32|||||||Chi-squared|||||||0.32
91765236|NCT03369418|183419367|SUPERIORITY|One tailed t-tests for independent groups were performed to test the hypothesis that active device will be superior to sham in decreasing the combined HAD score. This was accomplished by Contrast analysis within the framework of a random effects general linear mixed effects (RE GLMM) model.||||||0.013||||||A priori threshold for statistical significance was p\<.05.|t-test, 1 sided|||||||.013
91765237|NCT03369418|183419368|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.33
91545131|NCT06546657|182968887|OTHER||Mean Difference (Final Values)|1.74||||0.14|TWO_SIDED|95.0|-0.6|4.0||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||Medium GI vs low GI breakfast meals||4.0|-0.6|0.14
91545132|NCT06546657|182968887|OTHER||Mean Difference (Final Values)|4.4||||0.01|TWO_SIDED|95.0|1.2|7.5|||Linear Mixed Model|||Medium vs high GI breakfast meals||7.5|1.2|0.01
91545133|NCT06546657|182968887|OTHER||Mean Difference (Final Values)|-2.63||||0.12|TWO_SIDED|95.0|-6.0|0.7||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||High GI vs low GI breakfast meals||0.7|-6.0|0.12
91545134|NCT06546657|182968888|OTHER||Mean Difference (Final Values)|0.1815||||0.65|TWO_SIDED||||||Linear Mixed Model|||High GI breakfast meals vs low and medium GI breakfast meals||||0.65
91545135|NCT06546657|182968889|OTHER||Mean Difference (Final Values)|0.431||||0.25|TWO_SIDED|95.0|-0.3|1.2|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||1.2|-0.3|0.25
91545136|NCT06546657|182968890|OTHER||Mean Difference (Final Values)|22.0||||0.04|TWO_SIDED|95.0|0.6|44.0|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||44|0.6|0.04
91545137|NCT06546657|182968891|OTHER||Mean Difference (Final Values)|1.3||||0.01|TWO_SIDED|95.0|0.4|2.1|||Linear Mixed Model|||Breakfast cereals meals vs added protein meals||2.1|0.4|0.01
91545138|NCT06546657|182968893|OTHER|Comparison of diurnal and nocturnal glucose variability (CV%)|Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91545139|NCT03481660|182968910|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-0.6|3.1|||ANOVA|||BCVA at Week 52||3.1|-0.6|<0.001
91545140|NCT03481660|182968911|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-0.9|2.6|||ANOVA|||BCVA over period Week 40 through Week 52||2.6|-0.9|<0.001
91545141|NCT03481660|182968911|SUPERIORITY|||||||0.164|||||||ANOVA|||BCVA over period Week 40 through Week 52||||0.164
91545142|NCT03481660|182968918|OTHER|Treatment Difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-0.6|3.1||||||BCVA at Week 52||3.1|-0.6|
91545143|NCT03481660|182968918|OTHER|Treatment Difference|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|0.2|4.9||||||BCVA at Week 100||4.9|0.2|
91545144|NCT03481660|182968919|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.6|2.1||||||BCVA over period Week 4 through Week 52||2.1|-0.6|
91545145|NCT03481660|182968919|OTHER|Treatment difference|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.4|2.6||||||BCVA over period Week 4 through Week 100||2.6|-0.4|
91545146|NCT03481660|182968920|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-0.9|2.4||||||BCVA over period Week 20 through Week 52||2.4|-0.9|
91545147|NCT03481660|182968920|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-0.9|2.5||||||BCVA over period Week 28 through Week 52||2.5|-0.9|
91545148|NCT03481660|182968920|OTHER|Treatment difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-0.5|2.9||||||BCVA over period Week 20 through Week 100||2.9|-0.5|
91545149|NCT03481660|182968920|OTHER|Treatment difference|LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-0.5|3.0||||||BCVA over period Week 28 through Week 100||3.0|-0.5|
91545150|NCT03481660|182968921|OTHER|Treatment difference|LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-0.1|4.3||||||BCVA over period Week 88 through Week 100||4.3|-0.1|
91545151|NCT03481660|182968922|OTHER|Treatment difference|Clopper-Pearson exact method|0.4|||||TWO_SIDED|95.0|-7.6|8.9||||||Gain of \>= 5 letters in BCVA at Week 52||8.9|-7.6|
91545152|NCT03481660|182968922|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.5||||||Gain of \>= 5 letters in BCVA at Week 100||14.5|-3.9|
91545153|NCT03481660|182968923|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.7||||||Gain of \>= 10 letters in BCVA at Week 52||14.7|-3.9|
91545154|NCT03481660|182968923|OTHER|Treatment difference|Clopper-Pearson exact method|9.9|||||TWO_SIDED|95.0|-0.4|19.4||||||Gain of \>= 10 letters in BCVA at Week 100||19.4|-0.4|
91545155|NCT03481660|182968924|OTHER|Treatment difference|Clopper-Pearson exact method|9.6|||||TWO_SIDED|95.0|-0.4|20.2||||||Gain of \>= 15 letters in BCVA at Week 52||20.2|-0.4|
91545156|NCT03481660|182968924|OTHER|Treatment difference|Clopper-Pearson exact method|13.6|||||TWO_SIDED|95.0|3.3|23.5||||||Gain of \>= 15 letters in BCVA at Week 100||23.5|3.3|
91545157|NCT03481660|182968925|OTHER|Treatment difference|Clopper-Pearson exact method|-0.4|||||TWO_SIDED|95.0|-4.2|2.9||||||Loss of \>= 5 letters in BCVA at Week 52||2.9|-4.2|
91545158|NCT03481660|182968925|OTHER|Treatment difference|Clopper-Pearson exact method|-6.0|||||TWO_SIDED|95.0|-10.8|-1.7||||||Loss of \>= 5 letters in BCVA at Week 100||-1.7|-10.8|
91545159|NCT03481660|182968926|OTHER|Treatment difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.2|2.4||||||Loss of \>= 10 letters in BCVA at Week 52||2.4|-3.2|
91545160|NCT03481660|182968926|OTHER|Treatment difference|Clopper-Pearson exact method|-4.1|||||TWO_SIDED|95.0|-8.4|-0.1||||||Loss of \>= 10 letters in BCVA at Week 100||-0.1|-8.4|
91545161|NCT03481660|182968927|OTHER|Treatment difference|Clopper-Pearson exact method|-0.7|||||TWO_SIDED|95.0|-3.2|1.6||||||Loss of \>= 15 letters in BCVA at Week 52||1.6|-3.2|
91545162|NCT03481660|182968927|OTHER|Treatment difference|Clopper-Pearson exact method|-1.3|||||TWO_SIDED|95.0|-4.8|2.0||||||Loss of \>= 15 letters in BCVA at Week 100||2.0|-4.8|
91765238|NCT01426958|183419369|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|119.3|STANDARD_DEVIATION|11.5||0.1009|TWO_SIDED|90.0|112.239|126.811||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||126.811|112.239|0.1009
91545163|NCT03481660|182968928|OTHER|Treatment difference|Clopper-Pearson exact method|3.5|||||TWO_SIDED|95.0|-4.9|12.0||||||Absolute BCVA \>= 73 letters at Week 52||12.0|-4.9|
91545164|NCT03481660|182968928|OTHER|Treatment difference|Clopper-Pearson exact method|3.6|||||TWO_SIDED|95.0|-5.4|12.6||||||Absolute BCVA \>= 73 letters at Week 100||12.6|-5.4|
91545165|NCT03481660|182968930|OTHER|Treatment difference|LS mean difference|-29.4|STANDARD_ERROR_OF_MEAN|9.76|<|0.003|TWO_SIDED|95.0|-48.6|-10.2|||ANOVA|||CSFT over period Week 40 through Week 52||-10.2|-48.6|<0.003
91545166|NCT03481660|182968930|SUPERIORITY|||||||0.001|||||||ANOVA|||CSFT over period Week 40 through Week 52||||0.001
91545167|NCT03481660|182968930|OTHER|Treatment difference|LS mean difference|-23.2|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-43.5|-3.0||||||CSFT over period Week 88 through Week 100||-3.0|-43.5|
91545168|NCT03481660|182968931|OTHER|Treatment difference|LS mean difference|-27.4|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-45.8|-9.0||||||CSFT over period Week 4 through Week 52||-9.0|-45.8|
91545169|NCT03481660|182968931|OTHER|Treatment difference|LS mean difference|-25.8|STANDARD_ERROR_OF_MEAN|9.29|||TWO_SIDED|95.0|-44.0|-7.5||||||CSFT over period Week 4 through Week 100||-7.5|-44.0|
91545170|NCT03481660|182968932|OTHER|Treatment difference|Clopper-Pearson exact method|16.3|||||TWO_SIDED|95.0|5.7|25.9||||||CSFT thickness (\<280 micrometers) at Week 52||25.9|5.7|
91545171|NCT03481660|182968932|OTHER|Treatment difference|Clopper-Pearson exact method|14.7|||||TWO_SIDED|95.0|4.2|24.9||||||CSFT thickness (\<280 micrometers) at Week 100||24.9|4.2|
91545172|NCT03481660|182968933|OTHER||Clopper-Pearson exact method|-1.2|||||TWO_SIDED|95.0|-4.5|2.1||||||Subretinal Fluid (SRF) at Week 52||2.1|-4.5|
91545173|NCT03481660|182968933|OTHER|Treatment Difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.4|3.4||||||Subretinal Fluid (SRF) at Week 100||3.4|-3.4|
91545174|NCT03481660|182968934|OTHER|Treatment Difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-28.9|-9.2||||||Intraretinal Fluid (IRF) at Week 52||-9.2|-28.9|
91545175|NCT03481660|182968934|OTHER|Treatment Difference|Clopper-Pearson exact method|-16.1|||||TWO_SIDED|95.0|-26.3|-5.7||||||Intraretinal Fluid (IRF) at Week 100||-5.7|-26.3|
91545176|NCT03481660|182968935|OTHER|Treatment Difference|Clopper-Pearson exact method|-18.4|||||TWO_SIDED|95.0|-28.5|-8.3||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 52||-8.3|-28.5|
91545177|NCT03481660|182968935|OTHER|Treatment difference|Clopper-Pearson exact method|-16.2|||||TWO_SIDED|95.0|-26.4|-5.9||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 100||-5.9|-26.4|
91545178|NCT03481660|182968936|OTHER|Treatment difference|Clopper-Pearson exact method|-25.4|||||TWO_SIDED|95.0|-34.4|-16.3||||||Fluorescein Angiography (FA) at Week 52||-16.3|-34.4|
91545179|NCT03481660|182968936|OTHER|Treatment difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-29.1|-8.2||||||Fluorescein Angiography (FA) at Week 100||-8.2|-29.1|
91545180|NCT03481660|182968937|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-5.6|7.8||||||\>=2-step improvement in ETDRS-DRSS at Week 52||7.8|-5.6|
91545181|NCT03481660|182968937|OTHER|Treatment difference|Clopper-Pearson exact method|4.5|||||TWO_SIDED|95.0|-1.7|10.8||||||\>=2-step improvement in ETDRS-DRSS at Week 100||10.8|-1.7|
91545182|NCT03481660|182968938|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-7.1|5.7||||||\>=3-step improvement in ETDRS-DRSS at Week 52||5.7|-7.1|
91545183|NCT03481660|182968938|OTHER|Treatment difference|Clopper-Pearson exact method|3.9|||||TWO_SIDED|95.0|-2.3|10.0||||||\>=3-step improvement in ETDRS-DRSS at Week 100||10.0|-2.3|
91545184|NCT03481660|182968939|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-1.0|3.6||||||\>=2-step worsening in ETDRS-DRSS at Week 52||3.6|-1.0|
91545185|NCT03481660|182968939|OTHER|Treatment difference|Clopper-Pearson exact method|2.9|||||TWO_SIDED|95.0|-0.5|6.9||||||\>=2-step worsening in ETDRS-DRSS at Week 100||6.9|-0.5|
91765239|NCT01426958|183419369|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.23|STANDARD_DEVIATION|10.9||0.0009|TWO_SIDED|90.0|103.837|117.006||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||117.006|103.837|0.0009
91545186|NCT03481660|182968940|OTHER|Treatment difference|Clopper-Pearson exact method|0.6|||||TWO_SIDED|95.0|0.5|2.1||||||\>=3-step worsening in ETDRS-DRSS at Week 52||2.1|0.5|
91545187|NCT03481660|182968940|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-2.6|1.3||||||\>=3-step worsening in ETDRS-DRSS at Week 100||1.3|-2.6|
91545188|NCT03481660|182968941|OTHER|Treatment difference|Clopper-Pearson exact method|0.0|||||TWO_SIDED|95.0|-2.1|1.9||||||Proliferative diabetic retinopathy (PDR) of at least 61 by Week 100||1.9|-2.1|
91545189|NCT02879448|182968977|NON_INFERIORITY|The non-inferiority margin was developed based on reported rates for other devices. Therefore, the expected rate of the safety endpoint was assumed to be 15%. A non-inferiority margin of 5.8% represents a relative risk of 1.39.||||||0.0002|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p1(Amulet) - p1 (Watchman) ≥ Δ1~H1: p1(Amulet) - p1(Watchman) \< Δ1;~where Δ1 is the absolute value of the non-inferiority margin for the safety endpoint and p1 is the probability of a primary safety endpoint event."||||0.0002
91545190|NCT02879448|182968978|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported rates of ischemic stroke or systemic embolism for the Watchman. The 18-month rate of ischemic stroke or systemic embolism for the Watchman device has been reported in the literature as 4.2%. A non-inferiority margin of 3.2%, which represents a relative risk of 1.76, ensured that the rate observed was at most twice the rate expected with oral anticoagulant therapy.|||||<|0.0001|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p2(Amulet) - p2(Watchman) ≥ Δ2~H1: p2(Amulet) - p2(Watchman) \< Δ2;~where Δ2 is the absolute value of the non-inferiority margin for the effectiveness endpoint and p2 is the probability of a subject experiencing a primary effectiveness endpoint event."||||<0.0001
91545191|NCT02879448|182968979|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported closure rate for the Watchman device. The rate of device closure for the Watchman device has been reported in the literature as 95% (i.e., 5% had a residual jet \> 5mm). A non-inferiority margin of -3%, which represents a relative risk of 1.60, allows for trial to trial variability and implanter learning associated with implantation of a new device (Amulet).|||||<|0.0001|||||||Farrington Manning test|||"The following hypothesis was tested:~H0: p3(Amulet) - p3(Watchman) ≤ -Δ3~H1: p3(Amulet) - p3(Watchman) \> -Δ3;~where Δ3 is the absolute value of the non-inferiority margin and p3 is the 45-day closure probability."||||<0.0001
91765240|NCT01426958|183419369|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|91.9|STANDARD_DEVIATION|11.6||0.0004|TWO_SIDED|90.0|86.519|97.614||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||97.614|86.519|0.0004
91765241|NCT01426958|183419370|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|104.06|STANDARD_DEVIATION|14.2||0.0002|TWO_SIDED|90.0|96.681|112.002||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||112.002|96.681|0.0002
91765242|NCT01426958|183419370|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|105.09|STANDARD_DEVIATION|16.1||0.0012|TWO_SIDED|90.0|96.425|114.53||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||114.530|96.425|0.0012
91765243|NCT01426958|183419370|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|99.75|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|93.328|106.61||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||106.610|93.328|0.0000
91545192|NCT02879448|182968980|NON_INFERIORITY|"The following hypothesis was tested:~H1: p4(Amulet) - p4(Watchman) \< 4.5%"|||||<|0.0001|||||||Kaplan-Meier estimate|||||||<0.0001
91545193|NCT02879448|182968981|SUPERIORITY|"The following hypothesis was tested:~H1: p5(Amulet) - p5(Watchman) \< 0"||||||0.3229|||||||Kaplan-Meier estimate|||||||0.3229
91765244|NCT01426958|183419371|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|118.56|STANDARD_DEVIATION|11.5||0.0702|TWO_SIDED|90.0|111.712|125.822||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||125.822|111.712|0.0702
91765245|NCT01426958|183419371|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.76|STANDARD_DEVIATION|10.0||0.0005|TWO_SIDED|90.0|104.936|116.913||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||116.913|104.936|0.0005
91765246|NCT01426958|183419371|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.46|STANDARD_DEVIATION|11.9||0.0003|TWO_SIDED|90.0|86.928|98.341||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||98.341|86.928|0.0003
91545194|NCT02879448|182968982|SUPERIORITY|"The following hypothesis was tested:~H1: p1(Amulet) - p1(Watchman) \< 0"||||||0.466|||||||Kaplan-Meier estimate|||||||0.4660
91545195|NCT02879448|182968983|SUPERIORITY|"The following hypothesis was tested:~H1: p2(Amulet) - p2(Watchman) \< 0"||||||0.5017|||||||Kaplan-Meier estimate|||||||0.5017
91545196|NCT02879448|182968984|SUPERIORITY|"The following hypothesis was tested:~H1: p3(Amulet) - p3(Watchman) \> 0"||||||0.0025|||||||Farrington Manning test|||||||0.0025
91545197|NCT03433339|182968988|SUPERIORITY||||||=|0.04||||||p-value threshold for statistical significance \<0.05|ANOVA|Mixed ANOVA model considering all available data.||||||=0.040
91545198|NCT04970407|182969005|SUPERIORITY||Treatment difference|-1.16||||0.8769|TWO_SIDED|95.0|-16.25|13.93|||MMRM model|||The adjusted mean, standard error (SE) and 95% confidence interval (CI) of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||13.93|-16.25|0.8769
91545199|NCT04970407|182969005|SUPERIORITY||Treatment difference|-10.61||||0.162|TWO_SIDED|95.0|-25.69|4.47|||MMRM model|||The adjusted mean, SE and 95% CI of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||4.47|-25.69|0.1620
91545200|NCT04732494|182969034|SUPERIORITY|The primary endpoint ORR was tested at a 2-sided alpha of 0.05.|Risk Difference (RD)|9.9||||0.2114|TWO_SIDED|95.0|-5.4|25.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||25.3|-5.4|0.2114
91545201|NCT04732494|182969035|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.58|1.45|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.45|0.58|
91545202|NCT04732494|182969036|OTHER||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-9.2|22.5|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||22.5|-9.2|
91545203|NCT04732494|182969037|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.59|0.64|
91545204|NCT04732494|182969038|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.71|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.61|0.71|
91545205|NCT04732494|182969041|OTHER||Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-14.4|19.9|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Investigator||19.9|-14.4|
91545206|NCT04732494|182969041|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.7|21.8|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Independent Review Committee||21.8|-11.7|
91545207|NCT04732494|182969042|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-12.7|20.4|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Investigator||20.4|-12.7|
91545208|NCT04732494|182969042|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Independent Review Committee||21.0|-11.0|
91545209|NCT04732494|182969043|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-8.4|11.9||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.9|-8.4|
91545210|NCT04732494|182969043|OTHER||LS Mean Difference|3.1|||||TWO_SIDED|95.0|-5.0|11.2||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-5.0|
91545211|NCT04732494|182969043|SUPERIORITY||LS Mean Difference|-1.7|||||TWO_SIDED|95.0|-7.1|3.7||||||Analysis of Change from Baseline in Physical Functioning at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||3.7|-7.1|
91545212|NCT04732494|182969043|OTHER||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-10.3|9.3||||||Analysis of Change from Baseline in Physical Functioning at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.3|-10.3|
91545213|NCT04732494|182969044|OTHER||LS Mean Difference|-9.9|||||TWO_SIDED|95.0|-21.5|1.6||||||Analysis of Change from Baseline in Dysphagia at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.6|-21.5|
91545214|NCT04732494|182969044|OTHER||LS Mean Difference|-10.8|||||TWO_SIDED|95.0|-27.8|6.3||||||Analysis of Change from Baseline in Dysphagia at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.3|-27.8|
91545215|NCT04732494|182969044|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-7.3|6.6||||||Analysis of Change from Baseline in Eating at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.6|-7.3|
91545216|NCT04732494|182969044|OTHER||LS Mean Difference|-9.4|||||TWO_SIDED|95.0|-18.5|-0.3||||||Analysis of Change from Baseline in Eating at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||-0.3|-18.5|
91545217|NCT04732494|182969044|OTHER||LS Mean Difference|2.3|||||TWO_SIDED|95.0|-6.7|11.2||||||Analysis of Change from Baseline in Reflux at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-6.7|
91545218|NCT04732494|182969044|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-11.8|9.0||||||Analysis of Change from Baseline in Reflux at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.0|-11.8|
91545219|NCT04732494|182969044|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|-7.0|8.5||||||Analysis of Change from Baseline in Pain at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||8.5|-7.0|
91545220|NCT04732494|182969044|OTHER||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.3|1.7||||||Analysis of Change from Baseline in Pain at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.7|-12.3|
91545221|NCT02728557|182969049|OTHER|MLM models||||||0.016|||||||MLM|MLM||A model with two three-way interactions of time by treatment condition by attachment orientation (Time Å\~ Treatment condition Å\~ Attachment anxiety, Time Å\~ Treatment condition Å\~ Attachment avoidance) along the lower-level effects to predict differences in the slope of change in outcome. The threshold for statistical significance was p\>0.05.||||.016
91545222|NCT03416010|182969055|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no significant difference in Health Beliefs across those 4 time points.||||<0.001
91545223|NCT03416010|182969055|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the full intervention group, COPE-P, and the attention-control group, Preg+, in Health Beliefs, as measured by the Healthy Lifestyle Beliefs measure, at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth||||<0.001
91545224|NCT03416010|182969055|OTHER|||||||0.009|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||0.009
91545225|NCT03416010|182969056|OTHER||||||<|0.001||||||Threshold for significance: p \<0.01|two-way ANOVA|||Null hypothesis: there was no significant difference in anxiety across the 4 time points.||||<0.001
91545226|NCT03416010|182969056|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in anxiety at T0 baseline, as well as at timepoint 1(immediately following the intervention), timepoint 2 (6 weeks after the infants' birth), and timepoint 3 (6 months after the infants' birth).||||<0.001
91545227|NCT03416010|182969056|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
91545228|NCT03416010|182969057|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in health behaviors across those 4 time points.||||<0.001
91545229|NCT03416010|182969057|OTHER||||||<|0.001|||||||two-way ANOVA|||||||<0.001
91545230|NCT03416010|182969057|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
91545231|NCT03416010|182969058|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in depressive symptoms across those 4 timepoints.||||<0.001
91545232|NCT03416010|182969058|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in depressive symptoms at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth.||||<0.001
91545233|NCT03416010|182969058|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
91545234|NCT03416010|182969059|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in stress across those 4 time points.||||<0.001
91545235|NCT03416010|182969059|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in stress, as measured by the GAD-7, at T0 baseline, as well as at timepoint 1 (immediately following the intervention), timepoint 2 (6 weeks after the infants' birth) and timepoint 3 (6 months after the infants' birth).||||<0.001
91545236|NCT03416010|182969059|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
91545237|NCT05136404|182969099|OTHER||Ratio of Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.937|1.08|||Mixed Models Analysis|||||1.08|0.937|
91545238|NCT05136404|182969099|OTHER||Ratio of Geometric Least Squares Mean|1.04|||||TWO_SIDED|90.0|0.968|1.11|||Mixed Models Analysis|||||1.11|0.968|
91545239|NCT05136404|182969100|OTHER||Ratio of Geometric Least Squares Mean|0.989|||||TWO_SIDED|90.0|0.953|1.03|||Mixed Models Analysis|||||1.03|0.953|
91545240|NCT05136404|182969100|OTHER||Ratio of Geometric Least Squares Mean|1.02|||||TWO_SIDED|90.0|0.982|1.06|||Mixed Models Analysis|||||1.06|0.982|
91545241|NCT05136404|182969101|OTHER||Ratio of Geometric Least Squares Mean|1.01|||||TWO_SIDED|90.0|0.972|1.06|||Mixed Models Analysis|||||1.06|0.972|
91545242|NCT05136404|182969101|OTHER||Ratio of Geometric Least Squares Mean|1.03|||||TWO_SIDED|90.0|0.992|1.08|||Mixed Models Analysis|||||1.08|0.992|
91545243|NCT05136404|182969102|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4728|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.4728
91545244|NCT05136404|182969102|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0142|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.0142
91765247|NCT00040443|183419372|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.05
91765248|NCT05280717|183419383|OTHER||Ratio of geometric least square mean|0.9821|||||TWO_SIDED|90.0|0.8825|1.093|||||The ratio estimate and 90% confidence interval were obtained from an Analysis of covariance (ANCOVA) model, with AUC(D1- 29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0930|0.8825|
91765249|NCT05280717|183419384|OTHER||Ratio of geometric least square mean|1.1258|||||TWO_SIDED|90.0|1.0108|1.2539|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.2539|1.0108|
91765250|NCT05280717|183419387|OTHER||Ratio of geometric least square mean|1.876|||||TWO_SIDED|90.0|1.6391|2.1472|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.1472|1.6391|
91765251|NCT05280717|183419387|OTHER||Ratio of geometric least square mean|1.5991|||||TWO_SIDED|90.0|1.4086|1.8153|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.8153|1.4086|
91545245|NCT05568004|182969108|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.|||Statistical analysis was conducted by a researcher using the Statistical Package for Social Sciences (SPSS) version 26.0. The Shapiro-Wilk test and histograms evaluated the data for normal distribution, and the Levene test confirmed homogeneous variances between groups (p \> 0.05). Continuous data following a normal distribution are presented as mean ± standard deviation (SD). The independent samples t test or Mann-Whitney U test was used to compare independent continuous data between groups, while the chi-square or Fisher's exact test was used to compare categorical data. Friedman two-way ANOVA was used to analyze dependent variables, while the two-way mixed ANOVA was used to examine the changes between groups over time. Before the two-way mixed ANOVA, boxplot evaluation confirmed no outliers. Mauchly's sphericity test showed that the assumption of sphericity for two-way interaction was met. Tukey's correction was used for pairwise subgroup comparisons.|||0.001
91545246|NCT05568004|182969108|SUPERIORITY|||||||0.001|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||0.001
91765252|NCT05280717|183419388|OTHER||Ratio of geometric least square mean|2.0798|||||TWO_SIDED|90.0|1.8223|2.3737|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.3737|1.8223|
91765253|NCT05280717|183419388|OTHER||Ratio of geometric least square mean|1.6955|||||TWO_SIDED|90.0|1.4913|1.9276|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.9276|1.4913|
91545247|NCT05568004|182969108|SUPERIORITY|||||||0.166||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.166
91545248|NCT05568004|182969109|SUPERIORITY|||||||0.074||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.074
91545249|NCT05568004|182969109|SUPERIORITY|A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||||0.074|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.074
91545250|NCT05568004|182969109|SUPERIORITY|||||||0.311||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.311
91765254|NCT05280717|183419393|OTHER||Ratio of geometric least square mean|0.9476|||||TWO_SIDED|90.0|0.8578|1.0469|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0469|0.8578|
91765255|NCT05280717|183419393|OTHER||Ratio of geometric least square mean|1.5482|||||TWO_SIDED|90.0|1.377|1.7407|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.7407|1.3770|
91765256|NCT05280717|183419393|OTHER||Ratio of geometric least square mean|1.4167|||||TWO_SIDED|90.0|1.2627|1.5894|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.5894|1.2627|
91545251|NCT05568004|182969110|SUPERIORITY|||||||0.018||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.018
91545252|NCT05568004|182969110|SUPERIORITY|||||||0.152||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.152
91545253|NCT05568004|182969110|SUPERIORITY|||||||0.438||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.438
91545254|NCT05568004|182969111|SUPERIORITY|||||||0.135||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.135
91545255|NCT05568004|182969111|SUPERIORITY|||||||0.203||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.203
91545256|NCT05568004|182969111|SUPERIORITY|||||||0.593||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.593
91545257|NCT05568004|182969112|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
91545258|NCT05568004|182969112|SUPERIORITY|||||||0.021||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.021
91545259|NCT05568004|182969112|SUPERIORITY|||||||0.081||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.081
91545260|NCT05568004|182969113|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||<0.001
91545261|NCT05568004|182969113|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
91545262|NCT05568004|182969113|SUPERIORITY|||||||0.747||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.747
91545263|NCT05568004|182969114|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
91545264|NCT05568004|182969114|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
91545265|NCT05568004|182969114|SUPERIORITY|||||||0.05||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.05
91545266|NCT01820260|182969120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED|||||To account for multiple testing, the 4 pairwise tests with corresponding vehicle group were performed using Bonferroni method testing at a 1.25% significance level, securing that the overall significance level did not exceed 5%|Fisher Exact|||Complete clearance of AKs at Week 8 was to be analysed by log binomial regression with factors treatment group, anatomical location (face/chest or scalp) and analysis site. Due to the low numbers of subjects obtaining complete clearance in the vehicle groups,the proposed model did not converge and Fisher's exact test was used instead to compare active treatments with the respective vehicle arm.||||0.0002
91545267|NCT01820260|182969120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|TWO_SIDED|||||see comments in analysis 1|Fisher Exact|||See comment in analysis 1||||0.0037
91545268|NCT01820260|182969120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0171|TWO_SIDED|||||See comments in analysis 1|Fisher Exact|||See comments in analysis 1||||0.0171
91545269|NCT01820260|182969120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||||||0.0001
91765257|NCT03573323|183419405|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765258|NCT03573323|183419406|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765259|NCT03573323|183419407|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765260|NCT03573323|183419408|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765261|NCT03573323|183419409|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91545270|NCT01820260|182969121|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||To account for multiple testing among the secondary endpoints, a hierarchical order of testing was determined, where the following evaluation was done separately for each of the four active groups: Provided the primary endpoint was significant at a 1.25% level, the comparison to vehicle in terms of reduction in AK count from baseline to week 8 was tested at a 1.25% level. Provided this test was significant, the second secondary endpoint,partial clearance, was tested(vs. vehicle) at a 1.25% level||||< 0.001
91545271|NCT01820260|182969121|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment in analysis 1||||< 0.001
91545272|NCT01820260|182969121|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment analysis 1||||< 0.001
91545273|NCT01820260|182969121|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||z-test|||See comment in analysis 1||||< 0.001
91545274|NCT01820260|182969122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||Analysis of partial clearance of AK's at Week 8 was done in the same way as for the primary outcome (endpoint)||||<0.001
91545275|NCT01820260|182969122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91545276|NCT01820260|182969122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91545277|NCT01820260|182969122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
91545278|NCT04424927|182969152|OTHER||Least square (LS) mean difference|0.04||||0.8543|TWO_SIDED|95.0|-0.43|0.52|||MMRM|||Estimates/p-value are from a mixed model for repeated measures (MMRM) with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.52|-0.43|0.8543
91545279|NCT04424927|182969152|OTHER||LS mean difference|0.11||||0.6552|TWO_SIDED|95.0|-0.37|0.59|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.59|-0.37|0.6552
91545280|NCT04424927|182969152|OTHER||LS mean difference|0.04||||0.8705|TWO_SIDED|95.0|-0.45|0.53|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.53|-0.45|0.8705
91545281|NCT04424927|182969153|OTHER||LS mean difference|0.11||||0.6757|TWO_SIDED|95.0|-0.42|0.65|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.65|-0.42|0.6757
91545282|NCT04424927|182969153|OTHER||LS mean difference|-0.25||||0.3645|TWO_SIDED|95.0|-0.78|0.29|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.29|-0.78|0.3645
91545283|NCT04424927|182969153|OTHER||LS mean difference|-0.3||||0.2791|TWO_SIDED|95.0|-0.84|0.24|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.24|-0.84|0.2791
91545284|NCT04424927|182969154|OTHER||LS mean difference|0.05||||0.7829|TWO_SIDED|95.0|-0.32|0.42|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.42|-0.32|0.7829
91545285|NCT04424927|182969154|OTHER||LS mean difference|0.01||||0.9503|TWO_SIDED|95.0|-0.36|0.38|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.38|-0.36|0.9503
91545286|NCT04424927|182969154|OTHER||LS mean difference|-0.16||||0.4107|TWO_SIDED|95.0|-0.54|0.22|||MMRM|||Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.||0.22|-0.54|0.4107
91545287|NCT04424927|182969155|OTHER||LS mean difference|1.94||||0.4397|TWO_SIDED|95.0|-3.0|6.87|||ANCOVA|||Estimates/p-value are from an analysis of covariance (ANCOVA) model with treatment as a fixed effect. Continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio are included as covariates.||6.87|-3.00|0.4397
91545288|NCT04424927|182969155|OTHER||LS mean difference|-3.72||||0.1337|TWO_SIDED|95.0|-8.58|1.15|||ANCOVA|||Estimates/p-value are from an ANCOVA model with treatment as a fixed effect. Continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio are included as covariates.||1.15|-8.58|0.1337
91545289|NCT04424927|182969155|OTHER||LS mean difference|-4.14||||0.1021|TWO_SIDED|95.0|-9.11|0.83|||ANCOVA|||Estimates/p-value are from an ANCOVA model with treatment as a fixed effect. Continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio are included as covariates.||0.83|-9.11|0.1021
91545290|NCT01046136|182969176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0096|||||||Regression, Logistic|p-value is from a logistic regression model with terms for treatment group and center||Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.||||0.0096
91545291|NCT01046136|182969178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|||||||Wilcoxon (Mann-Whitney)|P-value is from a Wilcoxon rank sum test comparing the two treatment groups.||||||0.0293
91545292|NCT02058108|182969179|OTHER|Missing assessment imputed using the closest available assessment|Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-37.03|36.75|||Fisher Exact|||HBV DNA level of \<300 copies/mL (51 IU/mL) at Week 24|Exact confidence interval for the difference in percentage|36.75|-37.03|1.0000
91545293|NCT02058108|182969181|OTHER||Mean Difference (Net)|32.43||||0.2984|TWO_SIDED|95.0|-14.62|74.6|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|ALT levels at Week 24||74.60|-14.62|0.2984
91545294|NCT02058108|182969182|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg loss at Week 24||60.20|-53.70|1.0000
91545295|NCT02058108|182969182|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg seroconversion at Week 24||60.20|-53.70|1.0000
91545296|NCT02058108|182969183|OTHER||Mean Difference (Net)|2.44||||1|TWO_SIDED|95.0|-37.54|42.17|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBsAg loss at Week 24||42.17|-37.54|1.0000
91545297|NCT02058108|182969186|OTHER||Mean Difference (Net)|2.5||||1|TWO_SIDED|95.0|-37.05|41.83|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|Treatment emergent genotypic resistance at Week 24||41.83|-37.05|1.0000
91545298|NCT04110054|182969214|EQUIVALENCE|Placebo (N = 102) vs S-600918 50 mg, 150 mg, 300 mg||||||0.9334||||||P-value was evaluated at the 2-sided alpha level of 0.05.|ANCOVA|||The null hypotheses of equality between the treatment and placebo effects were tested using a mixed model, containing treatment group, week, and interaction between treatment groups and week as fixed effects; participant as random effect; and region and the common logarithm of the frequency of coughs per hour at baseline as covariates. Covariance structure was given as unstructured.||||0.9334
91545299|NCT01000480|182969226|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||P-value for H0 which compared the investigational regimen to historical data.|maximum likelihood estimate|||Null hypothesis (H0): 1-year PFS ≤45% and the alternative hypothesis (H1): 1-year PFS ≥60%, at a 2-sided alpha level of 5%, assuming that PFS time followed an exponential distribution.||||0.0645
91545300|NCT00595790|182969229|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of non-inferiority of IC51 1x12 mcg vs. IC51 2x6 mcg at Day 56 based on the difference (IC51 1x12 mcg - IC51 2x6 mcg) in SCRs in the PP population. Non-inferiority of IC51 1 x 12 mcg compared to IC51 2 x 6 mcg was accepted if the lower limit of the 95% CI of the adjusted for center SCR difference (IC51 1 x 12 mcg - IC51 2 x 6 mcg) was higher than the noninferiority margin at -10%.|||||>|0.99|||||||Mantel Haenszel|||||||>0.99
91545301|NCT02395978|182969238|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
91545302|NCT02539225|182969281|SUPERIORITY|||||||0.698|||||||Stratified Log Rank|||||||0.698
91545303|NCT02539225|182969282|SUPERIORITY|||||||0.549|||||||Log Rank Stratified|||||||0.549
91545304|NCT02539225|182969283|SUPERIORITY|||||||0.548|||||||Log Rank Stratified|||||||0.548
91545305|NCT02539225|182969284|SUPERIORITY||Odds Ratio (OR)|1.374||||0.402|TWO_SIDED|80.0|0.844|2.236|||Cochran-Mantel-Haenszel|||||2.236|0.844|0.402
91545306|NCT02539225|182969285|SUPERIORITY||Odds Ratio (OR)|1.527||||0.501|TWO_SIDED|80.0|0.68|3.433|||Cochran-Mantel-Haenszel|||||3.433|0.680|0.501
91545307|NCT00212134|182969291|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91545308|NCT00212134|182969292|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91545309|NCT00212134|182969293|OTHER|||||||0.82|||||||Chi-squared|||||||0.82
91545310|NCT00212134|182969294|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
91545311|NCT00212134|182969295|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
91545312|NCT00212134|182969296|SUPERIORITY||Mean Difference (Final Values)|15.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.||||<0.05
91545313|NCT00212134|182969298|SUPERIORITY||Mean Difference (Final Values)|7.295|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT comparison of mean PSI scores||||>0.05
91545314|NCT01553058|182969299|OTHER|Difference of Differences||||||0.795|||||||Regression, Linear|||||||0.795
91545315|NCT01553058|182969299|OTHER|Difference of differences||||||0.647|||||||Regression, Linear|||||||0.647
91545316|NCT01553058|182969300|OTHER|Difference of differences||||||0.386|||||||Regression, Linear|||||||0.386
91545317|NCT01553058|182969300|OTHER|Difference of Differences||||||0.28|||||||Regression, Linear|||||||0.280
91545318|NCT01553058|182969307|OTHER|Difference of Differences||||||0.357|||||||Regression, Linear|||||||0.357
91545319|NCT01553058|182969307|OTHER|Difference of Differences||||||0.496|||||||Regression, Linear|||||||0.496
91545320|NCT01553058|182969308|OTHER|Difference of Differences||||||0.897|||||||Regression, Linear|||||||0.897
91545321|NCT01553058|182969308|OTHER|Difference of differences||||||0.467|||||||Regression, Linear|||||||0.467
91545322|NCT01553058|182969309|OTHER|Difference of differences||||||0.089|||||||Regression, Linear|||||||0.089
91545323|NCT01553058|182969309|OTHER|Difference of differences||||||0.03|||||||Regression, Linear|||||||0.030
91545324|NCT01553058|182969310|OTHER|Difference of differences||||||0.934|||||||Regression, Linear|||||||0.934
91545325|NCT01553058|182969310|OTHER|Difference of differences||||||0.679|||||||Regression, Linear|||||||0.679
91545326|NCT01553058|182969311|OTHER|Difference of differences||||||0.672|||||||Regression, Linear|||||||0.672
91545327|NCT01553058|182969311|OTHER|Difference of differences||||||0.655|||||||Regression, Linear|||||||0.655
91545328|NCT01553058|182969312|OTHER|Difference of differences||||||0.504|||||||Regression, Linear|||||||0.504
91545329|NCT01553058|182969312|OTHER|Difference of differences||||||0.695|||||||Regression, Linear|||||||0.695
91545330|NCT01553058|182969313|OTHER|Difference of differences||||||0.002|||||||Regression, Linear|||||||0.002
91545331|NCT01553058|182969313|OTHER|Difference of differences||||||0.009|||||||Regression, Linear|||||||0.009
91545332|NCT01553058|182969314|OTHER|Difference of Differences|||||<|0.001|||||||Regression, Linear|||||||<0.001
91545333|NCT01553058|182969314|OTHER|Difference of differences||||||0.065|||||||Regression, Linear|||||||0.065
91545334|NCT01553058|182969315|OTHER|Difference of differences||||||0.007|||||||Regression, Linear|||||||0.007
91545335|NCT01553058|182969315|OTHER|Difference of differences||||||0.019|||||||Regression, Linear|||||||0.019
91545336|NCT01553058|182969316|OTHER|Difference of differences||||||0.006|||||||Regression, Linear|||||||0.006
91545337|NCT01553058|182969316|OTHER|Difference of differences||||||0.628|||||||Regression, Linear|||||||0.628
91545338|NCT01976312|182969468|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91545339|NCT02807779|182969501|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||"Power calculations were performed based on an expected reproducibility variance of 8% and an effect size of 7% was assumed based on data from pilot studies. It was estimated that 22 subjects/treatment assignment were needed to detect a 7% difference in PWV at a power level of 80%. Assigning a 20% attrition rate due to loss to follow up or index lesion revascularization, the goal enrollment was 27 subjects per arm.~No subjects in the plain balloon angioplasty group had MRI data for analysis."||||0.22
91545340|NCT02807779|182969502|SUPERIORITY|||||||0.64||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||0.64
91545341|NCT02807779|182969503|SUPERIORITY|||||||0.95||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete MCP-1 data for analysis.||||0.95
91545342|NCT02807779|182969504|SUPERIORITY|||||||0.88||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete CRP data for analysis.||||0.88
91545343|NCT02807779|182969506|SUPERIORITY|||||||0.055||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.055
91545344|NCT02807779|182969507|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.22
91545345|NCT02807779|182969508|SUPERIORITY|||||||0.81||||||Threshold for statistical significance was p=0.05.|Fisher Exact|||||||0.81
91545346|NCT02576509|182969510|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0752|TWO_SIDED|95.0|0.71|1.02||A priori threshold for statistical significance is 0.0419|Log Rank|Log-rank Test stratified by the stratification factors as entered into the IVRS|Nivolumab over Sorafenib; Stratified Cox proportional hazard model||95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)|1.02|0.71|0.0752
91545347|NCT02576509|182969511|OTHER|no test was performed due to OS p-value result above the prior threshold|Difference of ORRs|8.3|||||TWO_SIDED|95.0|3.9|12.7|||||Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors|||12.7|3.9|
91545348|NCT02576509|182969511|OTHER|no test was performed due to OS p-value result above the prior threshold|Odds Ratio (OR)|2.41|||||TWO_SIDED|95.0|1.48|3.92|||||Nivolumab over Sorafenib; Mantel-Haenszel estimator|||3.92|1.48|
91545349|NCT02576509|182969512|OTHER|no test was performed due to OS p-value result above the prior threshold|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1|||||Nivolumab over Sorafenib; Stratified Cox proportional hazard model|||1.10|0.79|
91545350|NCT02576509|182969513|OTHER|PD-L1 \>= 1%, OS; no test was performed|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Nivolumab over Sorafenib|||1.19|0.54|
91545351|NCT02576509|182969513|OTHER|PD-L1 \>=1%, PFS; no test was performed|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||||Nivolumab over Sorafenib|||1.03|0.48|
91545352|NCT02576509|182969513|OTHER|PD-L1 \<1%, OS; no test was performed|Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||||Nivolumab over Sorafenib|||1.02|0.69|
91545353|NCT02576509|182969513|OTHER|PD-L1 \<1%, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.81|1.17|||||Nivolumab over Sorafenib|||1.17|0.81|
91545354|NCT02576509|182969513|OTHER|without PD-L1 quantifiable, OS; no test was performed|Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.34|4.74|||||Nivolumab over Sorafenib|||4.74|0.34|
91545355|NCT02576509|182969513|OTHER|without PD-L1 quantifiable, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.27|3.52|||||Nivolumab over Sorafenib|||3.52|0.27|
91545356|NCT02576509|182969514|OTHER|PD-L1 \>=1%, ORR; no test was performed|Odds Ratio (OR)|3.79|||||TWO_SIDED|95.0|1.41|10.17|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.|||10.17|1.41|
91545357|NCT02576509|182969514|OTHER|PD-L1 \<1%, ORR; no test was performed|Odds Ratio (OR)|1.95|||||TWO_SIDED|95.0|1.1|3.45|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI|||3.45|1.10|
91545358|NCT03725722|182969522|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with adjusted p-value of \<0.025 were stat. sign. diff. from a flat dose-response model.~Model selected: Sigmoid Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in EASI score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.||||<0.0001
91545359|NCT03725722|182969522|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.01|TWO_SIDED|95.0|-5.0|-1.3||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.3|-5.0|<0.01
91765262|NCT03573323|183419410|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765263|NCT03573323|183419411|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765264|NCT03573323|183419412|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91765265|NCT03573323|183419413|SUPERIORITY|||||||0.414|||||||Cochran-Mantel-Haenszel|||||||0.414
91765266|NCT04502290|183419419|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the number of blocks after intervention will be not statistically significant.||||.04
91765267|NCT04502290|183419420|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the motor evoked potnetial after intervention will be not statistically significant.||||.02
91545360|NCT03725722|182969522|SUPERIORITY||Mean Difference (Net)|-3.0|||<|0.05|TWO_SIDED|95.0|-4.8|-1.2||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.2|-4.8|<0.05
91545361|NCT03725722|182969522|SUPERIORITY||Mean Difference (Net)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.1||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-2.1|-5.8|<0.0001
91545362|NCT03725722|182969522|SUPERIORITY||Median Difference (Net)|-5.7|||<|0.0001|TWO_SIDED|95.0|-7.5|-3.9||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-3.9|-7.5|<0.0001
91545363|NCT03725722|182969523|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model: Linear model"||This endpoint was evaluated by determining if there was a dose-response relationship between the vIGA-AD response rate at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response.||||<0.0001
91545364|NCT03725722|182969523|SUPERIORITY||Risk Difference (RD)|8.2|||>|0.05|TWO_SIDED|95.0|-5.6|21.9||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||21.9|-5.6|>0.05
91545365|NCT03725722|182969523|SUPERIORITY||Risk Difference (RD)|19.3|||<|0.05|TWO_SIDED|95.0|3.9|34.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||34.6|3.9|<0.05
91545366|NCT03725722|182969523|SUPERIORITY||Risk Difference (RD)|20.3|||<|0.05|TWO_SIDED|95.0|5.4|35.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||35.2|5.4|<0.05
91765268|NCT04502290|183419421|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the force after intervention will be not statistically significant.||||.04
91765269|NCT01290614|183419460|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
91765270|NCT01290614|183419461|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
91765271|NCT02109640|183419463|SUPERIORITY_OR_OTHER||Absolute percentage difference|17.1||||0.264|TWO_SIDED|95.0|-10.0|40.7||Absolute % difference 17.1 (95% CI -10.0,40.7)|Fisher Exact|||||40.7|-10.0|0.264
91765272|NCT02109640|183419464|SUPERIORITY_OR_OTHER|||||||0.222|||||||t-test, 2 sided|||||||0.222
91765273|NCT02109640|183419465|SUPERIORITY_OR_OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
91765274|NCT02336230|183419468|OTHER|||||||0.0003||||||P-value was calculated from the binomial distribution under the assumption of a 0.45 success rate for the null hypothesis.|Binomial Distribution|||||||0.0003
91765275|NCT02336230|183419470|OTHER|||||||0.0032||||||P-value was from a Cochran-Mantel-Haenszel (CMH) test stratified by baseline aGVHD grade.|CHM test|||||||0.0032
91765276|NCT01379183|183419477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91765277|NCT01379183|183419478|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANCOVA|||||||0.27
91765278|NCT01379183|183419479|SUPERIORITY_OR_OTHER|||||||0.96|||||||ANCOVA|||||||0.96
91545367|NCT03725722|182969523|SUPERIORITY||Risk Difference (RD)|38.3|||<|0.0001|TWO_SIDED|95.0|22.3|54.3||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||54.3|22.3|<0.0001
91545368|NCT03725722|182969524|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values were adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model:Emax model"||This endpoint was evaluated by determining if there was a dose-response relationship between EASI75 at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response||||<0.0001
91545369|NCT03725722|182969524|SUPERIORITY||Risk Difference (RD)|19.7|||<|0.05|TWO_SIDED|95.0|1.8|37.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||37.6|1.8|<0.05
91545370|NCT03725722|182969524|SUPERIORITY||Risk Difference (RD)|23.5|||<|0.05|TWO_SIDED|95.0|5.8|41.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||41.2|5.8|<0.05
91545371|NCT03725722|182969524|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.0005|TWO_SIDED|95.0|17.5|53.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||53.2|17.5|<0.0005
91545372|NCT03725722|182969524|SUPERIORITY||Risk Difference (RD)|45.4|||<|0.0001|TWO_SIDED|95.0|28.1|62.8||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||62.8|28.1|<0.0001
91545373|NCT03725722|182969525|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
91545374|NCT03725722|182969525|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||"vIGA-AD was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
91545375|NCT03725722|182969525|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||>0.05
91545376|NCT03725722|182969525|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD|||||<|0.001||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||<0.001
91545377|NCT01600014|182969526|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.44||||0.001|TWO_SIDED|95.0|1.32|4.51||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||4.51|1.32|0.001
91545378|NCT01600014|182969526|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.37||||0.013|TWO_SIDED|95.0|1.07|5.25||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and week of randomisation||The analysis type was superiority between groups. In total 62 subjects were included||5.25|1.07|0.013
91545379|NCT01600014|182969527|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.41||||0.016|TWO_SIDED|95.0|1.1|17.62||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||17.62|1.10|0.016
91545380|NCT01600014|182969527|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.24||||0.1|TWO_SIDED|95.0|0.78|6.47||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 62 subjects were included||6.47|0.78|0.10
91545381|NCT01600014|182969527|SUPERIORITY_OR_OTHER_LEGACY||Percent cleared subjects|50.0|||||TWO_SIDED|95.0|44.0|56.1|||||Estimation based on completers only.|Subjects randomised to vehicle were not included in the estimate of the overall clearance rate for the repeat-use regimen, from last treatment throught to Month 12. Instead, the subjects randomised to ingenol mebutate were given higher weights to reflect the hypothetical scenario where all randomised subjects were given active treatment during the repeat use cycle||56.1|44.0|
91545382|NCT01600014|182969528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.38||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using baseline observation carried forward (BOCF) as the imputation method.|The analysis type was superiority between groups. In total 141 subjects were included||-0.38|-1.38|<0.001
91545383|NCT01600014|182969528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.52|-0.51||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Sensitivity analysis using complete cases|Sensitivity analysis using complete cases|The analysis type was superiority between groups. In total 141 subjects were included||-0.51|-1.52|<0.001
91545384|NCT01600014|182969528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69||||0.008|TWO_SIDED|95.0|-1.19|-0.19||Formal statistical significance could not be established because of the closed test procedure where the first secondary endpoint tested (12 months clearance) did not reach statistical significance in the recurrent subgroup|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using BOCF as the imputation method, the difference in the adjusted mean AK count between the ingenol mebutate and vehicle groups|The analysis type was superiority between groups. In total 62 subjects were included||-0.19|-1.19|0.008
91545385|NCT02791230|182969530|SUPERIORITY||Hazard Ratio (HR)|0.6202||||0.0001|TWO_SIDED|95.0|0.4865|0.7906|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, Transthyretin (TTR) genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.7906|0.4865|0.0001
91765279|NCT01379183|183419480|SUPERIORITY_OR_OTHER|||||||0.71|||||||ANCOVA|||||||0.71
91545386|NCT02791230|182969533|SUPERIORITY||Hazard ratio|0.6133||||0.0005|TWO_SIDED|95.0|0.4666|0.8062|||Cox Proportional Hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.8062|0.4666|0.0005
91545387|NCT05769595|182969560|OTHER||Geometric Mean Ratio|2.51|||||TWO_SIDED|90.0|2.24|2.82|||||Geometric mean ratio is MK-2060/placebo|||2.82|2.24|
91765280|NCT01379183|183419481|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|||||||0.37
91765281|NCT01379183|183419482|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANCOVA|||||||0.12
91765282|NCT01695135|183419486|SUPERIORITY||Hazard Ratio (HR)|0.528||||0.0002|TWO_SIDED|95.0|0.376|0.74|||Log Rank|||||0.740|0.376|0.0002
91765283|NCT01775371|183419522|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.5||The a priori threshold for statistical significance was 0.05.|Z-test 2-sided||The direction of the comparison is the Patient Controlled Analgesia minus the standard care group|The rate of change of NRS pain scores per hour was calculated using a mixed effects linear model. Time is represented as a linear spline with knot at 30 minutes to support the separate estimation of early and late phase rates of change. Fixed effects in the analysis includes study-group indicator, early and late phase time, and interactions between study-group and time. The principal hypothesis test was a z-test of the coefficient of the study group late phase interaction term.||1.5|0.6|<0.001
91545388|NCT04605198|182969561|SUPERIORITY|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.|Mean Difference (Net)|-0.58||||0.846|TWO_SIDED|95.0|-6.46|5.29|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|||5.29|-6.46|.846
91545389|NCT04605198|182969562|SUPERIORITY||Mean Difference (Net)|-1.88||||0.139|TWO_SIDED|95.0|-4.36|0.6|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.60|-4.36|.139
91545390|NCT04605198|182969563|SUPERIORITY||Mean Difference (Net)|-0.12||||0.222|TWO_SIDED|95.0|-1.21|0.97|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.97|-1.21|.222
91545391|NCT04605198|182969564|SUPERIORITY||Odds Ratio, log|-1.76||||0.166|TWO_SIDED|95.0|-4.26|0.73|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed using a logit distribution. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was included as a fixed-effect. An independent covariance pattern was specified. Final models were random-intercept only.||0.73|-4.26|0.166
91545392|NCT04605198|182969565|SUPERIORITY||Mean Difference (Net)|-0.52||||0.737|TWO_SIDED|95.0|-3.57|2.53|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||2.53|-3.57|.737
91545393|NCT04605198|182969566|SUPERIORITY||Mean Difference (Net)|-2391.98||||0.024|TWO_SIDED|95.0|-4471.46|-312.49|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||-312.49|-4471.46|.024
91765284|NCT01775371|183419523|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
91765285|NCT01775371|183419524|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
91765286|NCT01775371|183419525|OTHER|Responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||These outcomes are based on the nurses who took care of patients in the study||||<0.001
91545394|NCT05307978|182969583|SUPERIORITY||Ratio (%)|68.729|||||TWO_SIDED|95.0|52.74|89.56|||Mixed Models Analysis|A mixed effect model was performed to the ln-transformed PK parameter and the independent variables.||||89.56|52.74|
91545395|NCT05307978|182969584|SUPERIORITY||Ratio (%)|120.043|||||TWO_SIDED|95.0|67.2|214.43|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||214.43|67.20|
91545396|NCT05307978|182969585|SUPERIORITY||Ratio (%)|118.142|||||TWO_SIDED|95.0|73.93|188.8|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||188.80|73.93|
91545397|NCT05307978|182969586|SUPERIORITY||Ratio (%)|93.891|||||TWO_SIDED|95.0|63.17|139.56|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||139.56|63.17|
91545398|NCT05075408|182969591|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|7.0||||0.3696|TWO_SIDED|97.5|-10.6|24.6||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 30 mg versus Placebo||24.6|-10.6|0.3696
91765287|NCT01775371|183419526|OTHER|All responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||This outcome is based on the physicians who took care of the patients in the study||||<0.001
91545399|NCT05075408|182969591|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|14.5||||0.0686|TWO_SIDED|97.5|-3.1|32.2||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 60 mg versus Placebo||32.2|-3.1|0.0686
91545400|NCT05075408|182969592|SUPERIORITY||Strata adjusted percentage difference|4.3||||0.5909|TWO_SIDED|97.5|-13.8|22.3|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||22.3|-13.8|0.5909
91545401|NCT05075408|182969592|SUPERIORITY||Strata adjusted percentage difference|12.9||||0.1112|TWO_SIDED|97.5|-5.5|31.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||31.4|-5.5|0.1112
91545402|NCT05075408|182969593|SUPERIORITY||Strata adjusted percentage difference|17.3||||0.0034|TWO_SIDED|97.5|4.3|30.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.4|4.3|0.0034
91545403|NCT05075408|182969593|SUPERIORITY||Strata adjusted percentage difference|17.1||||0.0025|TWO_SIDED|97.5|4.5|29.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||29.8|4.5|0.0025
91545404|NCT05075408|182969594|SUPERIORITY||Strata adjusted percentage difference|3.7||||0.5788|TWO_SIDED|97.5|-12.5|19.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||19.8|-12.5|0.5788
91545405|NCT05075408|182969594|SUPERIORITY||Strata adjusted percentage difference|16.5||||0.0303|TWO_SIDED|97.5|-0.8|33.9|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||33.9|-0.8|0.0303
91545406|NCT05075408|182969595|SUPERIORITY||Strata adjusted percentage difference|24.2||||0.0006|TWO_SIDED|97.5|8.8|39.6|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||39.6|8.8|0.0006
91545407|NCT05075408|182969595|SUPERIORITY||Strata adjusted percentage difference|20.8||||0.0021|TWO_SIDED|97.5|6.0|35.7|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||35.7|6.0|0.0021
91545408|NCT05075408|182969596|SUPERIORITY||Strata adjusted percentage difference|14.0||||0.0028|TWO_SIDED|97.5|3.8|24.1|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||24.1|3.8|0.0028
91545409|NCT05075408|182969596|SUPERIORITY||Strata adjusted percentage difference|19.0||||0.0003|TWO_SIDED|97.5|7.6|30.5|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.5|7.6|0.0003
91545410|NCT02380612|182969658|OTHER||Geometric Mean Ratio|1.4575|||||TWO_SIDED|||||||||||||
91545411|NCT02721381|182969662|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
91545412|NCT02721381|182969663|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
91545413|NCT02721381|182969664|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
91545414|NCT02721381|182969665|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
91545415|NCT02721381|182969666|SUPERIORITY|||||||0.98|||||||ANCOVA|||||||.98
91545416|NCT02721381|182969667|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||.69
91545417|NCT02721381|182969668|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.038
91545418|NCT02721381|182969669|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.45
91545419|NCT02721381|182969670|SUPERIORITY|||||||0.92|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.92
91545420|NCT02721381|182969671|SUPERIORITY|||||||0.42|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.42
91545421|NCT02721381|182969672|SUPERIORITY|||||||0.65|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.65
91545422|NCT02721381|182969673|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Independent samples t-test||||.001
91545423|NCT05687903|182969738|SUPERIORITY||Estimate of LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.983|=|0.001|TWO_SIDED|95.0|7.74|19.57||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||19.57|7.74|=0.001
91545424|NCT05687903|182969738|SUPERIORITY||Estimate of LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|2.921|<|0.001|TWO_SIDED|95.0|18.87|30.46||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||30.46|18.87|<0.001
91545425|NCT05687903|182969738|SUPERIORITY||Estimate of LS Mean Difference|26.58|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|20.81|32.35||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||32.35|20.81|<0.001
91545426|NCT05687903|182969738|SUPERIORITY||Estimate of LS Mean Difference|16.13|STANDARD_ERROR_OF_MEAN|2.842|<|0.001|TWO_SIDED|95.0|10.49|21.76||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||21.76|10.49|<0.001
91545427|NCT05687903|182969739|SUPERIORITY||Estimate of LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|1.564|=|0.004|TWO_SIDED|95.0|-9.53|-3.32||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-3.32|-9.53|=0.004
91545428|NCT05687903|182969739|SUPERIORITY||Estimate of LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-14.44|-8.16||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-8.16|-14.44|<0.001
91545429|NCT05687903|182969739|SUPERIORITY||Estimate of LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-13.35|-7.27||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-7.27|-13.35|<0.001
91545430|NCT05687903|182969739|SUPERIORITY||Estimate of LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-11.84|-5.75||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-5.75|-11.84|<0.001
91545431|NCT05687903|182969740|SUPERIORITY||IRR|0.48|||=|0.25|TWO_SIDED|95.0|0.25|0.93||GEE model featuring a negative binomial distribution was used for analysis where incidence rate was exponentiated LS mean \& incidence rate ratio (IRR) was exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.93|0.25|=0.250
91545432|NCT05687903|182969740|SUPERIORITY||IRR|0.36|||=|0.034|TWO_SIDED|95.0|0.16|0.79||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.79|0.16|=0.034
91545433|NCT05687903|182969740|SUPERIORITY||IRR|0.28|||=|0.003|TWO_SIDED|95.0|0.13|0.6||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.60|0.13|=0.003
91545434|NCT05687903|182969740|SUPERIORITY||IRR|0.67|||=|0.25|TWO_SIDED|95.0|0.35|1.29||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||1.29|0.35|=0.250
91545435|NCT04840199|182969775|SUPERIORITY||Mean Difference (Net)|-0.031||||0.2|TWO_SIDED|95.0|-0.08|0.018||No adjustment for multiple comparisons|Regression, Linear||Treatment effect was estimated as the difference in mean change in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a linear regression model (0 reflects no difference between arms).|||0.018|-0.080|0.20
91545436|NCT04840199|182969776|SUPERIORITY||Risk Difference (RD)|0.172||||0.19|TWO_SIDED|95.0|-0.073|0.438||No adjustment for multiple comparisons|Chan/Zhang exact test diff. proportions||An exact 95% confidence interval around the observed difference in proportions (and the associated p-value) was constructed based on the standardized statistic and inverting two 1-sided tests (Chan-Zhang method).|||0.438|-0.073|0.19
91545437|NCT04840199|182969778|SUPERIORITY||Odds Ratio (OR)|0.91||||0.12|TWO_SIDED|95.0|0.8|1.03||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||1.03|0.80|0.12
91545438|NCT04840199|182969778|SUPERIORITY||Odds Ratio (OR)|0.92||||0.009|TWO_SIDED|95.0|0.87|0.98||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.98|0.87|0.009
91545439|NCT04840199|182969778|SUPERIORITY||Odds Ratio (OR)|1.17||||0.24|TWO_SIDED|95.0|0.9|1.53||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||1.53|0.90|0.24
91545440|NCT04840199|182969781|SUPERIORITY||Mean Difference (Net)|0.0002||||0.95|TWO_SIDED|95.0|-0.0062|0.0066||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Early treatment phase comparison||0.0066|-0.0062|0.95
91545441|NCT04840199|182969781|SUPERIORITY||Mean Difference (Net)|-0.0007||||0.28|TWO_SIDED|95.0|-0.0019|0.0005||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Late treatment phase comparison||0.0005|-0.0019|0.28
91545442|NCT04840199|182969781|SUPERIORITY||Mean Difference (Net)|0.0056||||0.077|TWO_SIDED|95.0|-0.0006|0.0118||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Post treatment phase comparison||0.0118|-0.0006|0.077
91545443|NCT04840199|182969782|SUPERIORITY||Mean Difference (Net)|0.0009||||0.72|TWO_SIDED|95.0|-0.004|0.0058||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||0.0058|-0.0040|0.72
91545444|NCT04840199|182969782|SUPERIORITY||Mean Difference (Net)|-0.0009||||0.13|TWO_SIDED|95.0|-0.0022|0.0003||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.0003|-0.0022|0.13
91545445|NCT04840199|182969782|SUPERIORITY||Mean Difference (Net)|0.0023||||0.17|TWO_SIDED|95.0|-0.001|0.0055||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||0.0055|-0.0010|0.17
91545446|NCT03857620|182969792|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.53|TWO_SIDED|95.0|-0.85|0.45|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||0.45|-0.85|0.53
91545447|NCT03857620|182969792|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.84|TWO_SIDED|95.0|-0.67|0.81|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.81|-0.67|0.84
91545448|NCT03857620|182969792|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.21|0.26|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.26|-1.21|0.19
91545449|NCT03857620|182969792|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.14|TWO_SIDED|95.0|-0.19|1.29|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||1.29|-0.19|0.14
91545450|NCT03857620|182969793|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.23|2.09|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||2.09|0.23|0.50
91545451|NCT03857620|182969793|SUPERIORITY||Odds Ratio (OR)|0.46||||0.21|TWO_SIDED|95.0|0.13|1.62|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.62|0.13|0.21
91545452|NCT03857620|182969793|SUPERIORITY||Odds Ratio (OR)|1.03||||0.96|TWO_SIDED|95.0|0.3|3.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||3.54|0.30|0.96
91545453|NCT03857620|182969793|SUPERIORITY||Odds Ratio (OR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.54|0.13|0.19
91765288|NCT00216671|183419561|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6.|Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|4.1||0.784|TWO_SIDED|95.0|-9.24|6.99||An ANCOVA model with treatment as factor was used. The comparison between the 2 treatment groups was performed based on the least-squares means obtained from the ANCOVA model.|ANCOVA|||Assuming a difference of 3 points in favor of early initiation of treatment with Risperdal Consta, a sample size of 87 subjects per treatment arm has a power of 80% to demonstrate non-inferiority at the 0.025-level (1-sided). It was expected that about 20% of randomized subjects had to be excluded from the per-protocol (PP) analysis. Therefore, 220 subjects were to be included.||6.99|-9.24|0.784
91765289|NCT00216671|183419564|SUPERIORITY_OR_OTHER|||||||0.8||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.800
91765290|NCT00216671|183419564|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
91765291|NCT00216671|183419564|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
91765292|NCT00216671|183419565|SUPERIORITY_OR_OTHER|||||||0.798||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.798
91765293|NCT00216671|183419565|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
91765294|NCT00216671|183419565|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
91765295|NCT00216671|183419566|SUPERIORITY_OR_OTHER|||||||0.519||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.519
91765296|NCT00216671|183419566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
91765297|NCT00216671|183419566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
91765298|NCT00216671|183419566|SUPERIORITY_OR_OTHER|||||||0.721||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.721
91765299|NCT00216671|183419566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
91545454|NCT05145257|182969804|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545455|NCT05145257|182969805|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545456|NCT05145257|182969806|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545457|NCT05145257|182969807|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545458|NCT05145257|182969808|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91765300|NCT00216671|183419566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
91765301|NCT02714569|183419568|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Square Means Percentage|204.8|||||TWO_SIDED|90.0|161.9|259.0|||||Analysis was the estimate of the ratio fasted versus fed.|Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg||259.0|161.9|
91765302|NCT02714569|183419570|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Squares Mean Percentage|193.3|||||TWO_SIDED|90.0|144.7|258.2||||||Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg||258.2|144.7|
91765303|NCT02714569|183419582|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|141.0|||||TWO_SIDED|90.0|67.9|293.0||||||Part B Placebo||293.0|67.9|
91765304|NCT02714569|183419582|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|70.8|||||TWO_SIDED|90.0|31.9|157.1||||||Part B 5 mg LY||157.1|31.9|
91765305|NCT02714569|183419582|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|109.2|||||TWO_SIDED|90.0|99.8|119.5||||||Part B 20 mg LY||119.5|99.8|
91765306|NCT02714569|183419582|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|107.7|||||TWO_SIDED|90.0|68.1|170.4||||||Part B 100 mg LY||170.4|68.1|
91765307|NCT02714569|183419582|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|213.3|||||TWO_SIDED|90.0|200.3|227.1||||||Part B 300 mg LY||227.1|200.3|
91765308|NCT02714569|183419582|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|115.4|||||TWO_SIDED|90.0|91.2|146.2||||||Part B Overall||146.2|91.2|
91765309|NCT02714569|183419583|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|155.0|||||TWO_SIDED|90.0|87.6|274.2||||||Part B Placebo||274.2|87.6|
91765310|NCT02714569|183419583|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|71.5|||||TWO_SIDED|90.0|40.7|125.3||||||Part B 5 mg LY||125.3|40.7|
91765311|NCT02714569|183419583|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratios (%)|122.4|||||TWO_SIDED|90.0|90.7|165.1||||||Part B 20 mg LY||165.1|90.7|
91545459|NCT05145257|182969809|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545460|NCT05145257|182969810|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545461|NCT05145257|182969811|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545462|NCT05145257|182969812|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545463|NCT05145257|182969813|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545464|NCT05145257|182969814|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545465|NCT05145257|182969815|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545466|NCT05145257|182969816|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545467|NCT05145257|182969817|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545468|NCT05145257|182969818|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545469|NCT05145257|182969819|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
91545470|NCT04995484|182969820|OTHER||Geometric Mean Ratio|1.52|||||TWO_SIDED|90.0|0.95|2.43|||||Moderate Hepatic Impairment/Healthy|||2.43|0.95|
91545471|NCT04995484|182969821|OTHER||Geometric Mean Ratio|1.09|||||TWO_SIDED|90.0|0.84|1.42|||||Moderate Hepatic Impairment/Healthy|||1.42|0.84|
91545472|NCT04995484|182969822|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.76|1.26|||||Moderate Hepatic Impairment/Healthy|||1.26|0.76|
91545473|NCT05623345|182969908|SUPERIORITY||Risk Difference (RD)|36.22|STANDARD_ERROR_OF_MEAN|17.43||0.0377|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0377
91765312|NCT02714569|183419583|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|136.6|||||TWO_SIDED|90.0|89.8|207.7||||||Part B 100 mg LY||207.7|89.8|
91765313|NCT02714569|183419583|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|132.6|||||TWO_SIDED|90.0|90.5|194.4||||||Part B 300 mg LY||194.4|90.5|
91765314|NCT02714569|183419583|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|112.2|||||TWO_SIDED|90.0|93.2|135.1||||||Part B Overall||135.1|93.2|
91765315|NCT02714569|183419584|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|97.3|||||TWO_SIDED|90.0|80.4|117.8||||||Part B Placebo||117.8|80.4|
91765316|NCT02714569|183419584|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|57.5|||||TWO_SIDED|90.0|31.3|106.0||||||||106.0|31.3|
91765317|NCT02714569|183419584|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|96.2|||||TWO_SIDED|90.0|66.8|138.7||||||Part B 20 mg LY||138.7|66.8|
91765318|NCT02714569|183419584|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|80.9|||||TWO_SIDED|90.0|45.8|142.7||||||Part B 100 mg LY||142.7|45.8|
91765319|NCT02714569|183419584|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|108.2|||||TWO_SIDED|90.0|40.2|291.2||||||Part B 300 mg LY||291.2|40.2|
91765320|NCT02714569|183419584|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|87.9|||||TWO_SIDED|90.0|67.4|114.7||||||Part B Overall||114.7|67.4|
91765321|NCT02714569|183419585|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|96.0|||||TWO_SIDED|90.0|90.2|102.1||||||Part B Placebo||102.1|90.2|
91545474|NCT05623345|182969908|SUPERIORITY||Risk Difference (RD)|27.69|STANDARD_ERROR_OF_MEAN|5.68|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545475|NCT05623345|182969908|SUPERIORITY||Risk Difference (RD)|24.44|STANDARD_ERROR_OF_MEAN|5.65|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545476|NCT05623345|182969909|SUPERIORITY||Risk Difference (RD)|43.71|STANDARD_ERROR_OF_MEAN|22.14||0.0483|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0483
91545477|NCT05623345|182969909|SUPERIORITY||Risk Difference (RD)|46.15|STANDARD_ERROR_OF_MEAN|7.62|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545478|NCT05623345|182969909|SUPERIORITY||Risk Difference (RD)|52.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545479|NCT05623345|182969910|SUPERIORITY||Risk Difference (RD)|32.26|STANDARD_ERROR_OF_MEAN|18.93||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0883
91545480|NCT05623345|182969910|SUPERIORITY||Risk Difference (RD)|9.19|STANDARD_ERROR_OF_MEAN|8.35||0.2713|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2713
91545481|NCT05623345|182969910|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|8.44||0.8872|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.8872
91545482|NCT05623345|182969911|SUPERIORITY||Risk Difference (RD)|23.45|STANDARD_ERROR_OF_MEAN|16.9||0.1654|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1654
91545483|NCT05623345|182969911|SUPERIORITY||Risk Difference (RD)|26.58|STANDARD_ERROR_OF_MEAN|5.53|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545484|NCT05623345|182969911|SUPERIORITY||Risk Difference (RD)|25.84|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545485|NCT05623345|182969912|SUPERIORITY||Risk Difference (RD)|43.09|STANDARD_ERROR_OF_MEAN|16.85||0.0106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0106
91545486|NCT05623345|182969912|SUPERIORITY||Risk Difference (RD)|28.46|STANDARD_ERROR_OF_MEAN|6.22|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545487|NCT05623345|182969912|SUPERIORITY||Risk Difference (RD)|23.7|STANDARD_ERROR_OF_MEAN|6.4||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0002
91545488|NCT05623345|182969913|SUPERIORITY||Risk Difference (RD)|30.15|STANDARD_ERROR_OF_MEAN|19.11||0.1147|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1147
91765322|NCT02714569|183419585|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|90.7|||||TWO_SIDED|90.0|59.8|137.6||||||Part B 5 mg LY||137.6|59.8|
91765323|NCT02714569|183419585|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|99.9|||||TWO_SIDED|90.0|75.9|131.5||||||Part B 20 mg LY||131.5|75.9|
91765324|NCT02714569|183419585|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|91.0|||||TWO_SIDED|90.0|67.5|122.7||||||Part B 100 mg LY||122.7|67.5|
91765325|NCT02714569|183419585|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|87.0|||||TWO_SIDED|90.0|42.0|180.5||||||Part B 300 mg LY||180.5|42.0|
91765326|NCT02714569|183419585|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|93.5|||||TWO_SIDED|90.0|81.8|106.9||||||Part B Overall||106.9|81.8|
91765327|NCT00587678|183419596|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Linear repeated measures model|||||||0.32
91765328|NCT00587678|183419596|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||vs. baseline|Linear repeated measures model|||||||<0.01
91765329|NCT00587678|183419597|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Linear repeated measures model|||||||0.31
91765330|NCT00587678|183419597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
91765331|NCT00587678|183419598|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Linear repeated measures model|||||||0.71
91765332|NCT00587678|183419599|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Linear repeated measures model|||||||0.67
91545489|NCT05623345|182969913|SUPERIORITY||Risk Difference (RD)|29.04|STANDARD_ERROR_OF_MEAN|5.92|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545490|NCT05623345|182969913|SUPERIORITY||Risk Difference (RD)|24.99|STANDARD_ERROR_OF_MEAN|5.81|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91545491|NCT05623345|182969914|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.166||0.514|TWO_SIDED|95.0|-0.22|0.44|||Mixed model repeated measures analysis|||||0.44|-0.22|0.514
91545492|NCT05623345|182969914|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.01|TWO_SIDED|95.0|-0.28|-0.04|||Mixed model repeated measures analysis|||||-0.04|-0.28|0.010
91545493|NCT05623345|182969914|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Mixed model repeated measures analysis|||||-0.05|-0.29|0.006
91545494|NCT05384730|182969922|SUPERIORITY|||||||0.1|||||||ANOVA|||Light physical activity compared overtime||||0.10
91545495|NCT05384730|182969922|SUPERIORITY|||||||0.3|||||||ANOVA|||Moderate-vigorous physical activity compared overtime||||0.30
91545496|NCT05384730|182969922|SUPERIORITY|||||||0.18|||||||ANOVA|||Inactive/sedentary time compared overtime||||0.18
91545497|NCT05384730|182969923|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
91545498|NCT05384730|182969924|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
91545499|NCT05384730|182969925|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
91545500|NCT05384730|182969926|SUPERIORITY|||||||0.03|||||||Chi-squared|||Comparing depression scores overtime||||0.03
91545501|NCT05384730|182969926|SUPERIORITY|||||||0.96|||||||Chi-squared|||Comparing anxiety scores overtime||||0.96
91545502|NCT05384730|182969927|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
91545503|NCT05384730|182969928|SUPERIORITY|||||||0.13|||||||ANOVA|||||||0.13
91545504|NCT05384730|182969929|SUPERIORITY|||||||0.01|||||||ANOVA|||PASE analysis over time||||0.01
91545505|NCT01619410|182969932|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91545506|NCT02885636|182969968|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
91545507|NCT02885636|182969969|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
91545508|NCT02885636|182969970|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
91765333|NCT00587678|183419600|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Linear repeated measures model|||||||0.37
91765334|NCT00587678|183419600|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
91765335|NCT00587678|183419601|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Linear repeated measures model|||||||0.78
91765336|NCT00587678|183419602|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Linear repeated measures model|||||||0.68
91765337|NCT00587678|183419603|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Linear repeated measures model|||||||<0.05
91765338|NCT00587678|183419604|SUPERIORITY_OR_OTHER||||||=|0.67||95.0|||||linear repeated measures model|||||||=0.67
91765339|NCT00587678|183419605|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Linear repeated measures model|||||||0.77
91765340|NCT00587678|183419606|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Linear repeated measures model|||||||0.85
91765341|NCT00773513|183419630|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025.|Hazard Ratio (HR)|1.03||||0.0039|TWO_SIDED|95.0|0.93|1.15|||Regression, Cox||The pre-specified upper non-inferiority limit was 95% CI \<1.20.|||1.15|0.93|0.0039
91545509|NCT02885636|182969971|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.9
91545510|NCT02885636|182969972|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91545511|NCT02885636|182969973|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
91545512|NCT02885636|182969974|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
91545513|NCT02885636|182969975|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
91545514|NCT02885636|182969976|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
91545515|NCT02885636|182969977|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91545516|NCT02885636|182969978|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91545517|NCT02885636|182969979|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
91545518|NCT02885636|182969980|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
91545519|NCT02885636|182969981|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91545520|NCT02252172|182970139|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|<0.0001
91545521|NCT02252172|182970140|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.8|3.3|||Cochran-Mantel-Haenszel|||||3.30|1.80|<0.0001
91545522|NCT02252172|182970141|SUPERIORITY||Odds Ratio (OR)|3.4|||<|0.0001|TWO_SIDED|95.0|2.42|4.77|||Cochran-Mantel-Haenszel|||||4.77|2.42|<0.0001
91545523|NCT02252172|182970142|SUPERIORITY||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.55|5.59|||Fisher Exact|||||5.59|2.55|<0.0001
91545524|NCT02252172|182970143|SUPERIORITY||Odds Ratio (OR)|2.98|||<|0.0001|TWO_SIDED|95.0|2.09|4.24|||Cochran-Mantel-Haenszel|||||4.24|2.09|<0.0001
91545525|NCT02252172|182970144|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.0001|TWO_SIDED|95.0|1.85|4.86|||Cochran-Mantel-Haenszel|||||4.86|1.85|<0.0001
91545526|NCT02252172|182970145|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.82|||Log Rank|||||0.82|0.55|<0.0001
91545527|NCT02252172|182970146|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.39|0.62|||Log Rank|||||0.62|0.39|<0.0001
91545528|NCT02252172|182970149|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.63|||Log Rank|||||0.63|0.41|<0.0001
91545529|NCT02252172|182970150|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.49|0.76|||Log Rank|||||0.76|0.49|<0.0001
91545530|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|2.4|||=|0.0986|TWO_SIDED|95.0|-0.4|5.2|||Mixed Models Analysis|||For Cycle 3 Day 1||5.2|-0.4|=0.0986
91545531|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|1.5|||=|0.3042|TWO_SIDED|95.0|-1.4|4.4|||Mixed Models Analysis|||Cycle 6 Day 1||4.4|-1.4|=0.3042
91545532|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|1.8|||=|0.2339|TWO_SIDED|95.0|-1.2|4.9|||Mixed Models Analysis|||Cycle 9 Day 1||4.9|-1.2|=0.2339
91545533|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|3.3|||=|0.0365|TWO_SIDED|95.0|0.2|6.3|||Mixed Models Analysis|||Cycle 12 Day 1||6.3|0.2|=0.0365
91545534|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|1.7|||=|0.3093|TWO_SIDED|95.0|-1.6|4.9||Cycle 24 Day 1|Mixed Models Analysis|||Cycle 18 Day 1||4.9|-1.6|=0.3093
91545535|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|1.6|||=|0.3481|TWO_SIDED|95.0|-1.8|5.0|||Mixed Models Analysis|||Cycle 24 Day 1||5|-1.8|=0.3481
91545536|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|1.0|||=|0.5825|TWO_SIDED|95.0|-2.6|4.6|||Mixed Models Analysis|||Cycle 30 Day 1||4.6|-2.6|=0.5825
91545537|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|2.7|||=|0.1566|TWO_SIDED|95.0|-1.0|6.4|||Mixed Models Analysis|||Cycle 36 Day 1||6.4|-1|=0.1566
91545538|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|1.8|||=|0.3858|TWO_SIDED|95.0|-2.2|5.7|||Mixed Models Analysis|||Cycle 42 Day 1||5.7|-2.2|=0.3858
91545539|NCT02252172|182970151|SUPERIORITY||Least Square Mean|0.8|||=|0.7296|TWO_SIDED|95.0|-3.5|5.0|||Least Square Mean Difference|||Cycle 48 Day 1||5|-3.5|=0.7296
91545540|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|-1.3|||=|0.5793|TWO_SIDED|95.0|-6.0|3.3|||Mixed Models Analysis|||Cycle 54 Day 1||3.3|-6|=0.5793
91545541|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|-0.8|||=|0.7756|TWO_SIDED|95.0|-6.1|4.5|||Mixed Models Analysis|||Cycle 60 Day 1||4.5|-6.1|=0.7756
91545542|NCT02252172|182970151|SUPERIORITY||Least Square Mean Difference|0.7|||=|0.8458|TWO_SIDED|95.0|-6.0|7.4|||Mixed Models Analysis|||Cycle 66 Day 1||7.4|-6|=0.8458
91545543|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.0|||=|0.1176|TWO_SIDED|95.0|-0.5|4.5|||Mixed Models Analysis|||Cycle 3 Day 1||4.5|-0.5|=0.1176
91545544|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.8|||=|0.0336|TWO_SIDED|95.0|0.2|5.4|||Mixed Models Analysis|||Cycle 6 Day 1||5.4|0.2|=0.0336
91545545|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.6|||=|0.0653|TWO_SIDED|95.0|-0.2|5.3|||Mixed Models Analysis|||Cycle 9 Day 1||5.3|-0.2|=0.0653
91545546|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|5.8|||=|0|TWO_SIDED|95.0|3.0|8.5|||Mixed Models Analysis|||Cycle 12 Day 1||8.5|3|=0.0000
91545547|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.0|||=|0.1805|TWO_SIDED|95.0|-0.9|4.8|||Mixed Models Analysis|||Cycle 18 Day 1||4.8|-0.9|=0.1805
91545548|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.7|||=|0.0783|TWO_SIDED|95.0|-0.3|5.7|||Mixed Models Analysis|||Cycle 24 Day 1||5.7|-0.3|=0.0783
91545549|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.4|||=|0.1422|TWO_SIDED|95.0|-0.8|5.5|||Mixed Models Analysis|||Cycle 30 Day 1||5.5|-0.8|=0.1422
91545550|NCT02252172|182970152|SUPERIORITY||Least Square Mean|3.2|||=|0.0575|TWO_SIDED|95.0|-0.1|6.5|||Least Square Mean Difference|||Cycle 36 Day 1||6.5|-0.1|=0.0575
91545551|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|1.1|||=|0.5339|TWO_SIDED|95.0|-2.4|4.5|||Mixed Models Analysis|||Cycle 42 Day 1||4.5|-2.4|=0.5339
91545552|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|1.3|||=|0.5015|TWO_SIDED|95.0|-2.4|5.0|||Mixed Models Analysis|||Cycle 48 Day 1||5|-2.4|=0.5015
91545553|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|2.3|||=|0.2512|TWO_SIDED|95.0|-1.7|6.3|||Mixed Models Analysis|||Cycle 54 Day 1||6.3|-1.7|=0.2512
91545554|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|-0.5|||=|0.8246|TWO_SIDED|95.0|-5.1|4.1|||Mixed Models Analysis|||Cycle 60 Day 1||4.1|-5.1|=0.8246
91545555|NCT02252172|182970152|SUPERIORITY||Least Square Mean Difference|-1.3|||=|0.664|TWO_SIDED|95.0|-7.0|4.5|||Mixed Models Analysis|||Cycle 66 Day 1||4.5|-7|=0.6640
91545556|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.016|||=|0.3069|TWO_SIDED|95.0|-0.015|0.046|||Mixed Models Analysis|||Cycle 3 Day 1||0.046|-0.015|=0.3069
91545557|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.019|||=|0.2472|TWO_SIDED|95.0|-0.013|0.05|||Mixed Models Analysis|||Cycle 6 Day 1||0.05|-0.013|=0.2472
91545558|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.011|||=|0.4972|TWO_SIDED|95.0|-0.021|0.044|||Mixed Models Analysis|||Cycle 9 Day 1||0.044|-0.021|=0.4972
91545559|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.029|||=|0.0841|TWO_SIDED|95.0|-0.004|0.062|||Mixed Models Analysis|||Cycle 12 Day 1||0.062|-0.004|=0.0841
91545560|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.027|||=|0.1296|TWO_SIDED|95.0|-0.008|0.062|||Mixed Models Analysis|||Cycle 18 Day 1||0.062|-0.008|=0.1296
91545561|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.033|||=|0.0762|TWO_SIDED|95.0|-0.003|0.07|||Mixed Models Analysis|||Cycle 24 Day 1||0.07|-0.003|=0.0762
91545562|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.014|||=|0.4859|TWO_SIDED|95.0|-0.025|0.052|||Mixed Models Analysis|||Cycle 30 Day 1||0.052|-0.025|=0.4859
91545563|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.011|||=|0.6031|TWO_SIDED|95.0|-0.029|0.051|||Mixed Models Analysis|||Cycle 36 Day 1||0.051|-0.029|=0.6031
91545564|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.051|||=|0.0178|TWO_SIDED|95.0|0.009|0.093|||Mixed Models Analysis|||Cycle 42 Day 1||0.093|0.009|=0.0178
91545565|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.007|||=|0.746|TWO_SIDED|95.0|-0.038|0.053|||Mixed Models Analysis|||Cycle 48 Day 1||0.053|-0.038|=0.7460
91545566|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.037|||=|0.1394|TWO_SIDED|95.0|-0.012|0.086|||Mixed Models Analysis|||Cycle 54 Day 1||0.086|-0.012|=0.1394
91545567|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.011|||=|0.6982|TWO_SIDED|95.0|-0.045|0.068|||Mixed Models Analysis|||Cycle 60 Day 1||0.068|-0.045|=0.6982
91545568|NCT02252172|182970153|SUPERIORITY||Least Square Mean Difference|0.069|||=|0.0543|TWO_SIDED|95.0|-0.001|0.14|||Mixed Models Analysis|||Cycle 66 Day 1||0.14|-0.001|=0.0543
91545569|NCT03830866|182970156|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.174|TWO_SIDED|95.0|0.65|1.08|||Log Rank|||||1.08|0.65|0.174
91545570|NCT03830866|182970157|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.203|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.203
91545571|NCT03830866|182970159|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.091|TWO_SIDED|95.0|0.6|1.04|||Log Rank|||||1.04|0.60|0.091
91545572|NCT03830866|182970160|SUPERIORITY||Odds Ratio (OR)|1.15||||0.465|TWO_SIDED|95.0|0.794|1.657|||Regression, Logistic|||||1.657|0.794|0.465
91545573|NCT03830866|182970161|SUPERIORITY||Odds Ratio (OR)|1.11||||0.469|TWO_SIDED|95.0|0.833|1.487|||Regression, Logistic|||||1.487|0.833|0.469
91545574|NCT00041938|182970169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4|TWO_SIDED|95.0|0.79|1.1||The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.||1.10|0.79|0.40
91545575|NCT00041938|182970170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.23||Secondary null hypothesis was tested at two-tailed alpha = 0.05.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.||1.23|0.93|0.33
91545576|NCT00041938|182970171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.005|TWO_SIDED|95.0|0.33|0.82|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.||0.82|0.33|0.005
91545577|NCT00041938|182970172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.22||||0.35||95.0|0.43|11.66|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.||11.66|0.43|0.35
91545578|NCT00041938|182970173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.91|TWO_SIDED|95.0|0.85|1.2|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|||1.20|0.85|0.91
91545579|NCT00041938|182970174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.58|1.64|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.||1.64|0.58|0.93
91545580|NCT00041938|182970175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.053|TWO_SIDED|95.0|0.998|1.47|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.||1.47|0.998|0.053
91545581|NCT00041938|182970176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|95.0|0.32|0.96|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.||0.96|0.32|0.03
91545582|NCT00041938|182970177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.77||||0.51|TWO_SIDED|95.0|0.32|9.88|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.||9.88|0.32|0.51
91545583|NCT00041938|182970178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.83||95.0|0.81|1.3|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||||1.30|0.81|0.83
91545584|NCT00041938|182970179|SUPERIORITY_OR_OTHER||Rate ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.36|3.12|||Regression, Poisson||The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.|||3.12|1.36|<0.001
91545585|NCT00041938|182970180|SUPERIORITY_OR_OTHER||Rate ratio|1.56|||<|0.001||95.0|1.34|1.81|||Regression, Poisson||Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.|||1.81|1.34|<0.001
91545586|NCT00262301|182970181|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|||||||0.003
91545587|NCT00262301|182970182|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
91545588|NCT00976495|182970185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|2.7177|||TWO_SIDED|95.0|-13.34|-2.49|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.49|-13.34|
91545589|NCT00976495|182970185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.7068|||TWO_SIDED|95.0|-12.87|-2.06|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.06|-12.87|
91545590|NCT00976495|182970186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.3613|||TWO_SIDED|95.0|-7.11|2.31|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||2.31|-7.11|
91545591|NCT00976495|182970186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.4112|||TWO_SIDED|95.0|-1.55|8.08|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||8.08|-1.55|
91545592|NCT00976495|182970187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.5072|||TWO_SIDED|95.0|-9.38|0.63|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||0.63|-9.38|
91545593|NCT00976495|182970187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|2.5474|||TWO_SIDED|95.0|-4.18|5.99|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.99|-4.18|
91545594|NCT00976495|182970188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|2.7812|||TWO_SIDED|95.0|-5.39|5.71|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.71|-5.39|
91545595|NCT00976495|182970188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.31|STANDARD_ERROR_OF_MEAN|2.8135|||TWO_SIDED|95.0|1.7|12.93|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||12.93|1.70|
91545596|NCT04154384|182970190|SUPERIORITY|A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 3 months follow-up.||||||0.035||||||A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 12 weeks follow-up.|Chi-squared|||||||0.035
91545597|NCT03398148|182970229|SUPERIORITY||Adjusted Risk Difference|9.6||||0.0324|TWO_SIDED|90.0|2.2|17.0||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||17.0|2.2|0.0324
91545598|NCT03398148|182970229|SUPERIORITY||Adjusted Risk Difference|8.4||||0.046|TWO_SIDED|90.0|1.5|15.3||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||15.3|1.5|0.0460
91545599|NCT03398148|182970229|SUPERIORITY||Adjusted Risk Difference|8.7||||0.0397|TWO_SIDED|90.0|1.7|15.6||P-value ≤ 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo).|||15.6|1.7|0.0397
91545600|NCT03398148|182970230|SUPERIORITY||Adjusted Risk Difference|14.0|||<|0.0001|TWO_SIDED|95.0|10.0|18.0||Type I error rate control.|Cochran-Mantel-Haenszel|Stratified by Advanced Therapy-IR status (yes vs no), Baseline steroid use (yes vs. no) and Baseline Adapted Mayo Score (≤ 7, \> 7).||||18.0|10.0|<0.0001
91545601|NCT03398148|182970231|SUPERIORITY||Adjusted Risk Difference|18.7||||0.0028|TWO_SIDED|90.0|8.4|29.0||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||29.0|8.4|0.0028
91545602|NCT03398148|182970231|SUPERIORITY||Adjusted Risk Difference|8.4||||0.0968|TWO_SIDED|90.0|0.1|16.7||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||16.7|0.1|0.0968
91545603|NCT03398148|182970231|SUPERIORITY||Adjusted Risk Difference|10.5||||0.0512|TWO_SIDED|90.0|1.6|19.3||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||19.3|1.6|0.0512
91545604|NCT03398148|182970233|SUPERIORITY||Adjusted Risk Difference|23.9||||0.0022|TWO_SIDED|90.0|11.0|36.7||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.7|11.0|0.0022
91545605|NCT03398148|182970233|SUPERIORITY||Adjusted Risk Difference|28.4||||0.0002|TWO_SIDED|90.0|15.7|41.1||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||41.1|15.7|0.0002
91545606|NCT03398148|182970233|SUPERIORITY||Adjusted Risk Difference|33.8|||<|0.0001|TWO_SIDED|90.0|20.7|46.9||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||46.9|20.7|<0.0001
91545607|NCT03398148|182970234|SUPERIORITY||Adjusted Risk Difference|10.2||||0.1842|TWO_SIDED|90.0|-2.4|22.9|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||22.9|-2.4|0.1842
91545608|NCT03398148|182970234|SUPERIORITY||Adjusted Risk Difference|23.2||||0.0041|TWO_SIDED|90.0|9.9|36.4||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.4|9.9|0.0041
91545609|NCT03398148|182970234|SUPERIORITY||Adjusted Risk Difference|13.1||||0.1117|TWO_SIDED|90.0|-0.4|26.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||26.6|-0.4|0.1117
91545610|NCT03398148|182970235|SUPERIORITY||Adjusted Risk Difference|8.3||||0.0192|TWO_SIDED|90.0|2.5|14.1||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.1|2.5|0.0192
91545611|NCT03398148|182970235|SUPERIORITY||Adjusted Risk Difference|4.8||||0.0706|TWO_SIDED|90.0|0.4|9.1||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.1|0.4|0.0706
91545612|NCT03398148|182970235|SUPERIORITY||Adjusted Risk Difference|8.7||||0.017|TWO_SIDED|90.0|2.7|14.6||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.6|2.7|0.0170
91545613|NCT03398148|182970236|SUPERIORITY|||||||0.7737|||||||Chi-squared|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7737
91545614|NCT03398148|182970236|SUPERIORITY|||||||0.7432|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7432
91545615|NCT03398148|182970236|SUPERIORITY|||||||0.7172|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7172
91545616|NCT03398148|182970237|SUPERIORITY||Adjusted Risk Difference|4.7||||0.0722|TWO_SIDED|90.0|0.4|9.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.0|0.4|0.0722
91545617|NCT03398148|182970237|SUPERIORITY||Adjusted Risk Difference|3.1||||0.148|TWO_SIDED|90.0|-0.4|6.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||6.6|-0.4|0.1480
91545618|NCT03398148|182970237|SUPERIORITY||Adjusted Risk Difference|1.7||||0.3042|TWO_SIDED|90.0|-1.0|4.5|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||4.5|-1.0|0.3042
91545619|NCT03398148|182970238|SUPERIORITY||Least Squares (LS) Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|2.13||0.003|TWO_SIDED|90.0|-9.94|-2.89||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||-2.89|-9.94|0.0030
91545620|NCT03398148|182970238|SUPERIORITY||Least Squares (LS) Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.11||0.0001|TWO_SIDED|90.0|-11.67|-4.71||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.71|-11.67|0.0001
91545621|NCT03398148|182970238|SUPERIORITY||Least Squares (LS) Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.14||0.0004|TWO_SIDED|90.0|-11.27|-4.19||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.19|-11.27|0.0004
91545622|NCT03398148|182970239|SUPERIORITY||Least Squares (LS) Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|6.47||0.0081|TWO_SIDED|90.0|6.61|28.0||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||28|6.61|0.0081
91545623|NCT03398148|182970239|SUPERIORITY||Least Squares (LS) Mean Difference|20.3|STANDARD_ERROR_OF_MEAN|6.37||0.0017|TWO_SIDED|90.0|9.74|30.79||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.79|9.74|0.0017
91545624|NCT03398148|182970239|SUPERIORITY||Least Squares (LS) Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|6.49||0.0024|TWO_SIDED|90.0|9.22|30.67||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.67|9.22|0.0024
91545625|NCT03398148|182970240|SUPERIORITY||Least Squares (LS) Mean Difference|1.208||||0.3315|TWO_SIDED|90.0|-0.8429|3.2596|||Mixed-effect model repeated measurement|||||3.2596|-0.8429|0.3315
91545626|NCT03398148|182970240|SUPERIORITY||LS Mean of Difference|2.447||||0.0451|TWO_SIDED|90.0|0.4415|4.4519||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||4.4519|0.4415|0.0451
91545627|NCT03398148|182970240|SUPERIORITY||LS Mean of Difference|2.392||||0.0543|TWO_SIDED|90.0|0.3498|4.4352||P-value ≤ 0.1|Mixed-effect model repeated measurement|||||4.4352|0.3498|0.0543
91545628|NCT03398148|182970241|SUPERIORITY||LS Mean of Difference|3.662||||0.0367|TWO_SIDED|90.0|0.7841|6.5402||P-value \<= 0.1|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||6.5402|0.7841|0.0367
91545629|NCT03398148|182970241|SUPERIORITY||LS Mean of Difference|4.19||||0.0151|TWO_SIDED|90.0|1.3656|7.0144||P-value \<= 0.05|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||7.0144|1.3656|0.0151
91545630|NCT03398148|182970241|SUPERIORITY||LS Mean of Difference|2.348||||0.1795|TWO_SIDED|90.0|-0.5322|5.2281|||Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||5.2281|-0.5322|0.1795
91545631|NCT03398148|182970242|SUPERIORITY||Least Squares (LS) Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.91||0.0422|TWO_SIDED|90.0|0.75|7.06||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.06|0.75|0.0422
91545632|NCT03398148|182970242|SUPERIORITY||Least Squares (LS) Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.87||0.0049|TWO_SIDED|90.0|2.23|8.42||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||8.42|2.23|0.0049
91545633|NCT03398148|182970242|SUPERIORITY||Least Squares (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.91||0.0156|TWO_SIDED|90.0|1.5|7.8||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.80|1.50|0.0156
91765342|NCT00773513|183419631|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|1.06||||0.0166|TWO_SIDED|95.0|0.94|1.19|||Regression, Cox|||||1.19|0.94|0.0166
91545634|NCT03398148|182970243|SUPERIORITY|||||||1||||||P-Value for comparisons between treatment groups and placebo group using Fisher's exact test.|Fisher Exact|||Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.||||1
91545635|NCT03398148|182970244|SUPERIORITY||Adjusted Risk Difference|28.6|||<|0.0001|TWO_SIDED|95.0|22.3|34.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||34.8|22.3|<0.0001
91545636|NCT03398148|182970245|SUPERIORITY||Adjusted Risk Difference|24.3|||<|0.0001|TWO_SIDED|95.0|19.3|29.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||29.4|19.3|<0.0001
91545637|NCT03398148|182970246|SUPERIORITY||Adjusted Risk Difference|16.6|||<|0.0001|TWO_SIDED|95.0|12.3|21.0||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||21.0|12.3|<0.0001
91545638|NCT03398148|182970247|SUPERIORITY||Adjusted Risk Difference|7.2|||<|0.0001|TWO_SIDED|95.0|4.2|10.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||10.2|4.2|<0.0001
91545639|NCT03398148|182970248|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.6|28.1||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||28.1|15.6|<0.0001
91545640|NCT03398148|182970249|SUPERIORITY||Adjusted Risk Difference|16.3|||<|0.0001|TWO_SIDED|95.0|10.3|22.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||22.4|10.3|<0.0001
91765343|NCT00773513|183419632|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.95||||0.0219|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox|||||1.19|0.76|0.0219
91545641|NCT03398148|182970250|SUPERIORITY||Adjusted Risk Difference|9.3||||0.0021|TWO_SIDED|95.0|3.4|15.3||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||15.3|3.4|0.0021
91545642|NCT03398148|182970251|SUPERIORITY||Adjusted Risk Difference|5.6|||<|0.0001|TWO_SIDED|95.0|3.5|7.7||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||7.7|3.5|<0.0001
91545643|NCT03398148|182970252|SUPERIORITY||Least Squares (LS) Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.13|5.97||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||5.97|3.13|<0.0001
91545644|NCT03398148|182970253|SUPERIORITY||Least Squares (LS) Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|13.38|23.25||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||23.25|13.38|<0.0001
91545645|NCT03398148|182970254|SUPERIORITY||Risk Difference (RD)|-4.8|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Chi-squared||95% CI for treatment differences is based on normal approximation of the binomial proportions.|||-2.2|-7.3|<0.0001
91545646|NCT03398148|182970255|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.0001|TWO_SIDED|95.0|17.9|30.5||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||30.5|17.9|<0.0001
91545647|NCT03398148|182970256|SUPERIORITY||Adjusted Risk Difference|18.6|||<|0.0001|TWO_SIDED|95.0|12.4|24.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||24.8|12.4|<0.0001
91545648|NCT03398148|182970257|SUPERIORITY||Least Squares (LS) Mean Difference|-1.627|||<|0.0001|TWO_SIDED|95.0|-2.3846|-0.8689||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.8689|-2.3846|<0.0001
91545649|NCT03398148|182970258|SUPERIORITY||Least Squares (LS) Mean Difference|-0.981|||<|0.0001|TWO_SIDED|95.0|-1.3285|-0.6326||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.6326|-1.3285|<0.0001
91545650|NCT03661359|182970262|OTHER|||||||0.727||||||correlation is significant at the 0.05 level (2 tailed)|pearson correlation|||Correlation between patient satisfaction and domains at risk.||||.727
91545651|NCT03661359|182970264|OTHER|||||||0.002||||||correlation is significant at the 0.01 level 2 tailed|pearson correlation|||correlation between physical quality of life and mental of life||||0.002
91545652|NCT03661359|182970266|OTHER|||||||0.727|TWO_SIDED|0.05|||||pearson correlation|||||||0.727
91545653|NCT03089125|182970267|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.038|TWO_SIDED|95.0|-0.61|-0.05||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||-0.05|-0.61|0.038
91545654|NCT03089125|182970268|SUPERIORITY||Mean Difference (Final Values)|-0.55|||>|0.99|TWO_SIDED|95.0|-2.2|1.1||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||1.10|-2.20|>0.99
91545655|NCT03089125|182970269|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.38|TWO_SIDED|95.0|-1.98|5.18|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||5.18|-1.98|0.380
91765344|NCT00773513|183419633|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.94||||0.0459|TWO_SIDED|95.0|0.7|1.25|||Regression, Cox|||||1.25|0.70|0.0459
91545656|NCT03089125|182970270|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.99|TWO_SIDED|95.0|-0.83|0.82|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||0.82|-0.83|0.990
91545657|NCT03089125|182970271|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.251|TWO_SIDED|95.0|-1.34|0.35|||ANCOVA|||||0.35|-1.34|0.251
91545658|NCT03089125|182970272|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.647|TWO_SIDED|95.0|-7.9|4.92|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||4.92|-7.90|0.647
91545659|NCT03089125|182970273|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.431|TWO_SIDED|95.0|-2.45|5.71||ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.|ANCOVA|||||5.71|-2.45|0.431
91545660|NCT03089125|182970274|SUPERIORITY||Between-group diff in change per 8 weeks|-0.06||||0.71|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.26|-0.38|0.710
91545661|NCT03089125|182970275|SUPERIORITY||Between-group diff in change per 8 weeks|0.38||||0.677|TWO_SIDED|95.0|-1.4|2.16|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||2.16|-1.40|0.677
91545662|NCT03089125|182970276|SUPERIORITY||Between-group diff in change per 8 weeks|-1.95||||0.33|TWO_SIDED|95.0|-5.87|1.97|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.97|-5.87|0.330
91545663|NCT03089125|182970277|SUPERIORITY||Between-group diff in change per 8 weeks|0.73||||0.098|TWO_SIDED|95.0|-0.13|1.59|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.59|-0.13|0.098
91765345|NCT00773513|183419634|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.91||||0.0048|TWO_SIDED|95.0|0.74|1.12|||Regression, Cox|||||1.12|0.74|0.0048
91545664|NCT03089125|182970278|SUPERIORITY||Between-group diff in change per 8 weeks|0.08||||0.845|TWO_SIDED|95.0|-0.76|0.93|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.93|-0.76|0.845
91545665|NCT03089125|182970279|SUPERIORITY||Between-group diff in change per 8 weeks|0.74||||0.837|TWO_SIDED|95.0|-6.33|7.77|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||7.77|-6.33|0.837
91545666|NCT03683069|182970288|SUPERIORITY|||||||0.823|||||||Regression, Linear|||adjusted to medication dose, sex, age, race||||0.823
91545667|NCT03683069|182970288|SUPERIORITY|||||||0.839|||||||Regression, Linear|||diastolic bp adjusted for medication dose sex,age, race||||.8390
91545668|NCT03683069|182970289|SUPERIORITY|||||||0.0101|||||||Wilcoxon (Mann-Whitney)|||||||.0101
91545669|NCT03683069|182970290|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
91545670|NCT03683069|182970291|SUPERIORITY||Hazard Ratio, log|0.7022||||0.09|TWO_SIDED||||||Kaplan-Meier using Gehan-Breslow-Wilcoxo|||||||.09
91545671|NCT03821844|182970292|SUPERIORITY||marginal interaction effect|1.33|STANDARD_ERROR_OF_MEAN|1.38|<|0.05|TWO_SIDED|95.0|-1.37|4.03|||Differences-in-Differences regression||||"Fixed effects: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Scale (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|4.03|-1.37|< 0.05
91545672|NCT03821844|182970293|SUPERIORITY||marginal interaction effect|0.06|||<|0.05|TWO_SIDED|95.0|0.03|0.09|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||"The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models. All models adjust for resident baseline covariates, an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. The reference category for the multinomial model for each outcome is None. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction."|0.09|0.03|< 0.05
91545673|NCT03821844|182970294|SUPERIORITY||Marginal Interaction Effect|-0.11|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|-0.3|0.08|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, nursing home corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Score (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|0.08|-0.30|< 0.05
91545674|NCT03821844|182970295|SUPERIORITY||average marginal effect|-3.61|STANDARD_ERROR_OF_MEAN|1.85|<|0.05|TWO_SIDED|95.0|-7.22|0.0|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.00|-7.22|< 0.05
91765346|NCT04739436|183419656|SUPERIORITY||Slope|5.29||||0.003|TWO_SIDED|95.0|1.8|8.79||Multiple comparisons were not conducted, so no adjustment of the p-value was necessary.|Regression, Linear|||A linear regression model was fit with outcome change in APHAB score between 3 months and baseline, predictor hearing aid fitting group (reference=bilateral), and covariate clinical site.||8.79|1.80|0.003
91765347|NCT04739436|183419657|SUPERIORITY|||||||0.584||||||No adjustments for multiple comparisons were done.|Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, what proportion of the time do you wear your hearing aid?||||0.584
91765348|NCT04739436|183419657|SUPERIORITY|||||||0.233|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, how much does your hearing aid help you?||||0.233
91545675|NCT03821844|182970296|SUPERIORITY||average marginal effect|-3.47|STANDARD_ERROR_OF_MEAN|2.08|<|0.05|TWO_SIDED|95.0|-7.55|0.06|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.06|-7.55|< 0.05
91545676|NCT03821844|182970297|SUPERIORITY||average marginal effect|-1.26|STANDARD_ERROR_OF_MEAN|2.05|<|0.05|TWO_SIDED|95.0|-5.28|2.76|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|2.76|-5.28|< 0.05
91545677|NCT03821844|182970299|SUPERIORITY||average marginal effect|-0.22|||<|0.05|TWO_SIDED|95.0|-1.14|0.7|||Differences-in-Differences regression||||Multilevel regression with covariates' adjustments was used to estimate the impact of the resident being in a treatment versus control nursing home on depressive symptoms.|0.70|-1.14|< 0.05
91545678|NCT03821844|182970300|SUPERIORITY||marginal interaction effect|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the behaviors of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.|0.02|-0.03|< 0.05
91545679|NCT03821844|182970301|SUPERIORITY||marginal interaction effect|0.05|||<|0.05|TWO_SIDED|95.0|0.02|0.07|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.07|0.02|< 0.05
91545680|NCT03821844|182970302|SUPERIORITY||marginal interaction effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.03|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.03|< 0.05
91545681|NCT03821844|182970303|SUPERIORITY||average marginal effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.04|< 0.05
91545682|NCT03821844|182970304|SUPERIORITY||marginal interaction effect|0.01|||<|0.05|TWO_SIDED|95.0|-0.02|0.03|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.03|-0.02|< 0.05
91545683|NCT03821844|182970305|SUPERIORITY||marginal interaction effect|-0.02|||<|0.05|TWO_SIDED|95.0|-0.05|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment vs. control NH had on the behaviors and moods of NH residents. The models were implemented separately for each mood. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), which is sometimes known as the Difference in Differences estimand.|0.01|-0.05|< 0.05
91545684|NCT03913195|182970310|EQUIVALENCE|The equivalence limits for the 90% confidence interval are 0.80 to 1.25. If the 90% CIs were within the equivalence limits (0.8, 1.25), it demonstrated a PK bridge between the two routes of administration.|Risk Ratio (RR)|1.0||||1|TWO_SIDED|90.0|0.8299|1.2049||H0: P1 is not different from P2.|Fisher Exact|||The proportion of subjects with an average Ctrough ≥ 300 ng/mL is compared between the 30-second IV push and the 15-minute IV infusion.||1.2049|0.8299|1.0
91545685|NCT03913195|182970311|EQUIVALENCE|The equivalence limits for the 90% confidence interval (CI) are 0.80 to 1.25. If the 90% CIs were within the equivalence limits (0.8, 1.25), it demonstrated a PK bridge between the two routes of administration.|mean geometric ratio|1.0315||||0.5389|TWO_SIDED|90.0|0.9478|1.1226|||SAS PROC MIXED|||The log transform of the ratio of the geometric means of the Area Under the Curve (AUC) for 30 second IV Push and 15 minute IV infusion is compared.||1.1226|0.9478|0.5389
91545686|NCT03913195|182970313|EQUIVALENCE|The equivalence limits for the 90% confidence interval are 0.80 to 1.25. If the 90% CIs were within the equivalence limits (0.8, 1.25), it demonstrated a PK bridge between the two routes of administration.|Risk Ratio (RR)|0.89||||0.34|TWO_SIDED|90.0|0.69|1.08|||Fisher Exact|||The proportion of subjects with an average Ctrough ≥ 300 ng/mL is compared between IM and IV infusion.||1.08|0.69|0.34
91545687|NCT03899961|182970314|SUPERIORITY|Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median Difference (Net)|0.0||||0.05|TWO_SIDED|95.0|-1.09|1.09||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median regression model for the change f|||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval||1.09|-1.09|0.05
91765349|NCT04739436|183419657|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, with your hearing aid, how much difficulty do you now have?||||0.010
91545688|NCT05107401|182970318|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.083|TWO_SIDED|95.0|-4.9|0.3|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.30|-4.90|0.083
91545689|NCT05107401|182970319|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.032|TWO_SIDED|95.0|-1.16|-0.18|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, age, sex at birth, and sexual orientation.||-0.18|-1.16|0.032
91545690|NCT05107401|182970320|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.48|TWO_SIDED|95.0|-0.72|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-0.72|0.48
91545691|NCT05107401|182970321|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.48|TWO_SIDED|95.0|-1.49|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-1.49|0.48
91545692|NCT05107401|182970322|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.37|TWO_SIDED|95.0|-2.6|0.51|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.51|-2.60|0.37
91545693|NCT05107401|182970323|SUPERIORITY||Risk Ratio (RR)|1.13||||0.099|TWO_SIDED|95.0|0.98|1.32|||Regression, Logistic||The statistical values presented are the relative risk between study arms at the three-month follow-up.|We used a generalized linear model using a binomial distribution to examine whether the intervention was associated with increased HIV self-testing uptake in the follow-up period. The model was adjusted for history of HIV testing (pre-intervention testing and testing prior to the study), whether the participant had submitted content to the JasSpark contest, and if the participant had a main intimate partner (e.g., girlfriend/boyfriend, spouse).||1.32|0.98|0.099
91545694|NCT05107401|182970324|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.012|TWO_SIDED|95.0|-8.59|-1.58||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in females between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||-1.58|-8.59|0.012
91545695|NCT05107401|182970324|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.56|TWO_SIDED|95.0|-2.26|5.42||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in males between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||5.42|-2.26|0.56
91545696|NCT05952076|182970332|OTHER||Adjusted mean difference|0.11||||0.6863|TWO_SIDED|95.0|-0.44|0.67|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ and baseline age (days). A random intercept for participant was included.|||0.67|-0.44|0.6863
91545697|NCT05952076|182970333|OTHER||Adjusted mean difference|109.3||||0.5567|TWO_SIDED|95.0|-259.76|478.36|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline weight (grams) and baseline age (days). A random intercept for participant was included.|||478.36|-259.76|0.5567
91545698|NCT05952076|182970334|OTHER||Adjusted mean difference|0.1||||0.7275|TWO_SIDED|95.0|-0.46|0.66|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ, baseline age (days) and study intervention compliance. A random intercept for participant was included.|||0.66|-0.46|0.7275
91545699|NCT04899115|182970364|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
91545700|NCT04899115|182970365|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|Wilcoxon was used because data was not normal.||||||0.48
91545701|NCT00894543|182970371|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
91545702|NCT00894543|182970375|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
91545703|NCT00894543|182970376|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||||||0.001
91545704|NCT04452318|182970411|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.332|||Regression, Logistic|||||0.332|0.090|< 0.0001
91545705|NCT04452318|182970412|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.038|TWO_SIDED|95.0|0.298|0.966|||Regression, Logistic|||||0.966|0.298|= 0.0380
91545706|NCT04452318|182970414|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.069|0.236|||Regression, Logistic|||||0.236|0.069|< 0.0001
91545707|NCT04452318|182970414|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0024|TWO_SIDED|95.0|0.228|0.728|||Regression, Logistic|||||0.728|0.228|= 0.0024
91545708|NCT04452318|182970415|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
91545709|NCT04452318|182970416|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
91545710|NCT04452318|182970416|SUPERIORITY||||||=|0.001|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0010
91765350|NCT04739436|183419657|SUPERIORITY|||||||0.129|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: For this situation, how satisfied are you with your hearing aid?||||0.129
91545711|NCT04452318|182970417|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
91545712|NCT04452318|182970418|SUPERIORITY||Odds Ratio (OR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.208|0.456|||Multiple Imputation, Logistic Regression|||||0.456|0.208|< 0.0001
91545713|NCT04452318|182970420|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.051|0.286|||Regression, Logistic|||||0.286|0.051|< 0.0001
91545714|NCT04452318|182970421|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
91545715|NCT04452318|182970422|SUPERIORITY||Odds Ratio (OR)|0.09|||=|0.001|TWO_SIDED|95.0|0.02|0.37|||Regression, Logistic|||||0.370|0.020|= 0.0010
91545716|NCT04452318|182970423|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
91545717|NCT04452318|182970426|SUPERIORITY||Difference of LS Means|-2.123|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|-2.707|-1.539|||ANOVA|||||-1.539|-2.707|< 0.0001
91545718|NCT04452318|182970427|SUPERIORITY||Difference of LS Means|-2.483|STANDARD_ERROR_OF_MEAN|0.342|<|0.0001|TWO_SIDED|95.0|-3.161|-1.806|||ANOVA|||||-1.806|-3.161|< 0.0001
91545719|NCT04452318|182970428|SUPERIORITY||Difference of LS Mean|-2.428|STANDARD_ERROR_OF_MEAN|0.389|<|0.0001|TWO_SIDED|95.0|-3.196|-1.659|||ANOVA|||||-1.659|-3.196|< 0.0001
91545720|NCT04452318|182970429|SUPERIORITY||Difference of LS Mean|-2.441|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.194|-1.688|||ANOVA|||||-1.688|-3.194|< 0.0001
91545721|NCT04452318|182970432|OTHER||||||=|0.0621|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0621
91545722|NCT04452318|182970433|OTHER||||||=|0.0038|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received'||||= 0.0038
91545723|NCT04452318|182970436|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
91765351|NCT04739436|183419658|SUPERIORITY|||||||0.946|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 3 months in the co-located BKB SIN test scores between the groups.||||0.946
91545724|NCT04452318|182970444|SUPERIORITY||||||=|0.0273|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0273
91545725|NCT04452318|182970445|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.046|TWO_SIDED|95.0|0.299|0.989|||Regression, Logistic|||||0.989|0.299|= 0.0460
91545726|NCT04452318|182970446|SUPERIORITY||Odds Ratio (OR)|0.47|||=|0.0721|TWO_SIDED|95.0|0.207|1.07|||Regression, Logistic|||||1.070|0.207|= 0.0721
91545727|NCT04452318|182970447|SUPERIORITY||||||=|0.026|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0260
91545728|NCT04452318|182970448|SUPERIORITY||||||=|0.0614|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0614
91545729|NCT04452318|182970449|SUPERIORITY||LS mean difference|-1.461|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-2.127|-0.795|||ANCOVA|||||-0.795|-2.127|< 0.0001
91545730|NCT04452318|182970450|SUPERIORITY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.279|=|0.0026|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||||-0.300|-1.400|= 0.0026
91545731|NCT04452318|182970451|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|-1.321|-0.559|||ANCOVA|||||-0.559|-1.321|< 0.0001
91545732|NCT04452318|182970452|SUPERIORITY||Difference of LS Mean|-26.045|STANDARD_ERROR_OF_MEAN|6.041|<|0.0001|TWO_SIDED|95.0|-37.973|-14.117|||ANCOVA|||||-14.117|-37.973|< 0.0001
91545733|NCT04452318|182970453|SUPERIORITY||Difference of LS Mean|-1.395|STANDARD_ERROR_OF_MEAN|0.338|<|0.0001|TWO_SIDED|95.0|-2.063|-0.727|||ANCOVA|||||-0.727|-2.063|< 0.0001
91545734|NCT04452318|182970454|SUPERIORITY||||||=|0.0138|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0138
91765352|NCT04739436|183419659|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recognition scores between the groups.||||0.490
91545735|NCT04452318|182970455|OTHER||||||=|0.0292|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0292
91545736|NCT04452318|182970456|OTHER||||||=|0.2466|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.2466
91545737|NCT04452318|182970457|SUPERIORITY||||||=|0.7861|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.7861
91545738|NCT04452318|182970458|SUPERIORITY||||||=|0.0842|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.0842
91545739|NCT01017146|182970470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
91545740|NCT01017146|182970470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
91545741|NCT01017146|182970470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
91545742|NCT01017146|182970471|SUPERIORITY_OR_OTHER||Percentage of participants|35.6|||<|0.001|TWO_SIDED|95.0|30.7|40.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||40.5|30.7|<0.001
91545743|NCT01017146|182970471|SUPERIORITY_OR_OTHER||Percentage of participants|23.9|||||TWO_SIDED|95.0|19.6|28.3|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||28.3|19.6|
91545744|NCT01017146|182970472|SUPERIORITY_OR_OTHER||Percentage of participants|28.8|||<|0.001|TWO_SIDED|95.0|24.2|33.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||33.5|24.2|<0.001
91545745|NCT01017146|182970472|SUPERIORITY_OR_OTHER||Percentage of participants|16.1|||||TWO_SIDED|95.0|12.4|19.9|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||19.9|12.4|
91545746|NCT02272816|182970487|OTHER||Percentage|95.6|||||ONE_SIDED|95.0||98.6||||||||98.6||
91545747|NCT02272816|182970488|OTHER||Percentage|45.0|||||TWO_SIDED|95.0|30.2|59.9||||||||59.9|30.2|
91545748|NCT02272816|182970489|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|92.6|100.0||||||||100|92.6|
91545749|NCT05321069|182970528|SUPERIORITY||Mean Difference (Net)|44.89||||0.0222|TWO_SIDED|95.0|6.44|83.33|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 9 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||83.33|6.44|0.0222
91545750|NCT05321069|182970528|SUPERIORITY||Mean Difference (Net)|68.83||||0.0005|TWO_SIDED|95.0|30.26|107.39|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 18 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||107.39|30.26|0.0005
91545751|NCT05321069|182970529|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.5443|TWO_SIDED|95.0|0.69|1.22|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment group, baseline antifibrotic therapy use, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (hemoglobin-corrected) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||1.22|0.69|0.5443
91545752|NCT05321069|182970529|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9512|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|||Based on Cox proportional hazards model including treatment, baseline antifibrotic therapy, age, baseline Forced Vital Capacity (FVC) percent predicted, and baseline Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percent predicted (corrected for haemoglobin) as covariates. p-values not adjusted for multiplicity.||1.31|0.75|0.9512
91545753|NCT05321069|182970530|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5583|TWO_SIDED|95.0|0.76|1.67|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.67|0.76|0.5583
91545754|NCT05321069|182970530|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5896|TWO_SIDED|95.0|0.75|1.65|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.65|0.75|0.5896
91545755|NCT05321069|182970531|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9038|TWO_SIDED|95.0|0.7|1.36|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.36|0.70|0.9038
91545756|NCT05321069|182970531|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.4687|TWO_SIDED|95.0|0.82|1.56|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.56|0.82|0.4687
91545757|NCT05321069|182970532|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7695|TWO_SIDED|95.0|0.74|1.25|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.25|0.74|0.7695
91545758|NCT05321069|182970532|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2068|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.10|0.64|0.2068
91545759|NCT05321069|182970533|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9251|TWO_SIDED|95.0|0.69|1.41|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.41|0.69|0.9251
91545760|NCT05321069|182970533|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4988|TWO_SIDED|95.0|0.62|1.26|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.26|0.62|0.4988
91545761|NCT05321069|182970534|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9084|TWO_SIDED|95.0|0.6|1.76|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.76|0.60|0.9084
91545762|NCT05321069|182970534|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4682|TWO_SIDED|95.0|0.46|1.43|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.43|0.46|0.4682
91545763|NCT05321069|182970535|SUPERIORITY||Mean Difference (Net)|-1.0||||0.3697|TWO_SIDED|95.0|-3.2|1.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 9mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.19|-3.20|0.3697
91545764|NCT05321069|182970535|SUPERIORITY||Mean Difference (Net)|-0.63||||0.5734|TWO_SIDED|95.0|-2.83|1.57|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 18mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.57|-2.83|0.5734
91545765|NCT05321069|182970536|SUPERIORITY||Mean Difference (Net)|-0.1||||0.9442|TWO_SIDED|95.0|-2.98|2.77|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.77|-2.98|0.9442
91765353|NCT04739436|183419659|SUPERIORITY|||||||0.323||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.||||0.323
91765354|NCT04739436|183419660|SUPERIORITY|||||||0.933||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 3 months.||||0.933
91765355|NCT04739436|183419660|SUPERIORITY|||||||0.929||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 6 months.||||0.929
91765356|NCT04739436|183419662|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||The null hypothesis is there is no difference in the change from baseline to 3 months in SSQ scores between the groups.||||0.015
91765357|NCT04739436|183419662|SUPERIORITY|||||||0.886|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 6 months in SSQ scores between the groups.||||0.886
91765358|NCT04739436|183419663|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the right ear.||||0.137
91765359|NCT04739436|183419663|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.||||0.612
91765360|NCT04739436|183419665|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 3 months.||||0.108
91545766|NCT05321069|182970536|SUPERIORITY||Mean Difference (Net)|-0.59||||0.6862|TWO_SIDED|95.0|-3.47|2.28|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.28|-3.47|0.6862
91545767|NCT05321069|182970537|SUPERIORITY||Mean Difference (Net)|0.19||||0.8759|TWO_SIDED|95.0|-2.25|2.63|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.63|-2.25|0.8759
91545768|NCT05321069|182970537|SUPERIORITY||Mean Difference (Net)|0.43||||0.732|TWO_SIDED|95.0|-2.02|2.87|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.87|-2.02|0.7320
91545769|NCT05321069|182970538|SUPERIORITY||Mean Difference (Net)|1.17||||0.028|TWO_SIDED|95.0|0.13|2.22|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 9 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.22|0.13|0.0280
91545770|NCT05321069|182970538|SUPERIORITY||Mean Difference (Net)|1.73||||0.0013|TWO_SIDED|95.0|0.68|2.78|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 18 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.78|0.68|0.0013
91545771|NCT05321069|182970539|SUPERIORITY||Mean Difference (Net)|2.49||||0.0042|TWO_SIDED|95.0|0.79|4.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 9 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||4.19|0.79|0.0042
91545772|NCT05321069|182970539|SUPERIORITY||Mean Difference (Net)|1.67||||0.053|TWO_SIDED|95.0|-0.02|3.37|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 18 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||3.37|-0.02|0.0530
91545773|NCT05048186|182970547|OTHER||Mean Difference (Final Values)|0.06||||0.503|TWO_SIDED|95.0|-0.116|0.236|||t-test, 2 sided|||we tested to see whether SDM Process scores were different between patients who received the Decision Aid Arm vs the control arm||0.236|-0.116|0.503
91545774|NCT02412748|182970556|SUPERIORITY|||||||0.962|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.962
91765361|NCT04739436|183419665|SUPERIORITY|||||||0.988||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 6 months.||||0.988
91765362|NCT04739436|183419668|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change in APHAB score from baseline to 6 months between the groups.||||0.264
91765363|NCT05919888|183419669|SUPERIORITY|||||||0.275|||||||Chi-squared|||||||0.275
91765364|NCT05919888|183419670|SUPERIORITY|||||||0.0056|||||||Chi-squared|||||||0.0056
91765365|NCT05919888|183419671|SUPERIORITY|||||||0.286|||||||Chi-squared|||||||0.286
91545775|NCT02412748|182970557|SUPERIORITY|||||||0.982|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.982
91545776|NCT02412748|182970558|SUPERIORITY|||||||0.534|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.534
91545777|NCT02412748|182970559|SUPERIORITY|||||||0.73|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.730
91545778|NCT02412748|182970560|SUPERIORITY|||||||0.927|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.927
91545779|NCT02412748|182970561|SUPERIORITY|||||||0.841|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.841
91545780|NCT02412748|182970562|SUPERIORITY|||||||0.722|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.722
91545781|NCT02412748|182970563|SUPERIORITY|||||||0.715|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.715
91545782|NCT02412748|182970564|SUPERIORITY|||||||0.9|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.900
91545783|NCT02412748|182970565|SUPERIORITY|||||||0.271|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.271
91545784|NCT02412748|182970566|SUPERIORITY|||||||0.987|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.987
91545785|NCT02412748|182970567|SUPERIORITY|||||||0.967|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.967
91545786|NCT02412748|182970568|SUPERIORITY|||||||0.693|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.693
91545787|NCT02412748|182970569|SUPERIORITY|||||||0.557|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.557
91545788|NCT02412748|182970570|SUPERIORITY|||||||0.681|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.681
91545789|NCT02412748|182970571|SUPERIORITY|||||||0.389|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.389
91545790|NCT02412748|182970572|SUPERIORITY|||||||0.846|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.846
91545791|NCT02412748|182970573|SUPERIORITY|||||||0.871|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.871
91545792|NCT02412748|182970574|SUPERIORITY|||||||0.986|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.986
91545793|NCT02412748|182970575|SUPERIORITY|||||||0.791|||||||ANCOVA|||||||.791
91545794|NCT02412748|182970576|SUPERIORITY|||||||0.583|||||||ANCOVA|||||||.583
91545795|NCT02412748|182970577|SUPERIORITY|||||||0.851|||||||ANCOVA|||||||.851
91545796|NCT04218266|182970619|OTHER||Crude incidence ratio|0.42|||||TWO_SIDED|90.0|0.26|0.67||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in all bleeding||0.67|0.26|
91545797|NCT04218266|182970621|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH CRNM bleeding||0.97|0.09|
91545798|NCT04218266|182970622|OTHER||Crude incidence ratio|0.47|||||TWO_SIDED|90.0|0.28|0.83||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH minor bleeding||0.83|0.28|
91545799|NCT04218266|182970623|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97|||Other|||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH major bleeding or CRNM bleeding||0.97|0.09|
91545800|NCT00879060|182970637|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||1.0
91545801|NCT00879060|182970637|OTHER||Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PIIINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.8
91545802|NCT00879060|182970637|OTHER||Mean Difference (Final Values)|0.3||||0.3|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.aseline.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable ICTP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.3
91545803|NCT00879060|182970637|OTHER||Absolute difference|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups.||||1.0
91545804|NCT00879060|182970638|OTHER||Absolute difference|1.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable peak oxygen consumption with exercise (peak VO2) between spironolactone treated and placebo groups.||||0.7
91545805|NCT00879060|182970639|OTHER||Absolute difference|0.0||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable New York Heart Association (NYHA) Functional Class between spironolactone treated and placebo groups.||||0.8
91545806|NCT00879060|182970640|OTHER||Absolute difference|1.4||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable Septal E/e' between spironolactone treated and placebo groups.||||1.0
91545807|NCT00879060|182970641|OTHER||Absolute difference|0.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable percentage of left ventricular mass (%LV) between spironolactone treated and placebo groups.||||0.7
91545808|NCT00879060|182970642|OTHER||Absolute difference|0.9||||0.4|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable maximum left ventricular wall thickness (Max LV) between spironolactone treated and placebo groups.||||0.4
91545809|NCT00879060|182970643|OTHER||Absolute difference|5.7||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left ventricular end-diastolic (LVED) cavity size between spironolactone treated and placebo groups.||||0.7
91545810|NCT00879060|182970644|OTHER||Absolute difference|0.1||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left atrial dimension between spironolactone treated and placebo groups.||||0.8
91545811|NCT01424670|182970686|SUPERIORITY|||||||0.0562||||||For testing the null hypothesis, the distribution of the time to SCC within the 6-month Intensive Period were compared between the 2 treatment groups using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test.|Modified Peto-Peto test|||Comparison of distributions of time to SCC using the MGIT culture system during the 6-month (26-week) Intensive Period.||||0.0562
91545812|NCT01424670|182970687|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.096||||0.3818|TWO_SIDED|95.0|0.889|1.352|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 2 months.||1.352|0.889|0.3818
91545813|NCT01424670|182970687|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.017||||0.7131|TWO_SIDED|95.0|0.927|1.115|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 6 months.||1.115|0.927|0.7131
91545814|NCT01424670|182970688|SUPERIORITY||Relative Ratio of Probability|0.969||||0.5945|TWO_SIDED|95.0|0.866|1.084|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 18.||1.084|0.866|0.5945
91545815|NCT01424670|182970688|SUPERIORITY||Relative Ratio of Probability|0.97||||0.6164|TWO_SIDED|95.0|0.864|1.089|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 24.||1.089|0.864|0.6164
91545816|NCT01424670|182970688|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 30.||1.127|0.872|0.8951
91545817|NCT01424670|182970689|SUPERIORITY||Relative Ratio of Probability|0.965||||0.5269|TWO_SIDED|95.0|0.869|1.073|||Cochran-Mantel-Haenszel|||Statistical comparison of proportions with favorable treatment outcomes assessed by the Principal Investigator.||1.073|0.869|0.5269
91545818|NCT01424670|182970691|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.6986|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA|||Statistical comparison of mean AUC of change from Baseline.||1.3|-1.9|0.6986
91545819|NCT01424670|182970692|SUPERIORITY|||||||0.6825|||||||ANCOVA|||Statistical analysis for Week 1.||||0.6825
91545820|NCT01424670|182970692|SUPERIORITY|||||||0.807|||||||ANCOVA|||Statistical analysis for Week 2.||||0.807
91545821|NCT01424670|182970692|SUPERIORITY|||||||0.269|||||||ANCOVA|||Statistical analysis for Week 3.||||0.269
91545822|NCT01424670|182970692|SUPERIORITY|||||||0.2333|||||||ANCOVA|||Statistical analysis for Week 24.||||0.2333
91545823|NCT01424670|182970692|SUPERIORITY|||||||0.9397|||||||ANCOVA|||Statistical analysis for Month 6.||||0.9397
91545824|NCT01424670|182970693|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with treatment success at Month 30.||1.127|0.872|0.8951
91545825|NCT02891915|182970720|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.|Pr (Higher DOOR in Short-Course)|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.75||Missing DOOR values at OAV #1 were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.75|0.63|<0.001
91545826|NCT02891915|182970721|SUPERIORITY|Testing whether Short course is superior to Standard course based on DOOR at OAV #2|Pr (Higher DOOR in Short-Course)|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.69||Missing DOOR values at OAV #2 were first imputed using linear regression using baseline covariates and available DOOR components as covariates|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value.||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower numerical value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.69|0.57|<0.001
91545827|NCT04048382|182970739|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED||||||Regression, Logistic|||||||.88
91545828|NCT04048382|182970740|SUPERIORITY||Odds Ratio (OR)|1.7||||0.49|TWO_SIDED||||||Regression, Logistic|||||||.49
91545829|NCT04048382|182970741|SUPERIORITY||Odds Ratio (OR)|1.1||||0.91|TWO_SIDED||||||Regression, Logistic|||||||.91
91545830|NCT04048382|182970742|SUPERIORITY||Odds Ratio (OR)|1.4||||0.65|TWO_SIDED||||||Regression, Logistic|||||||.65
91545831|NCT04048382|182970743|SUPERIORITY||Odds Ratio (OR)|0.29||||0.17|TWO_SIDED||||||Regression, Logistic|||||||.17
91545832|NCT04048382|182970744|SUPERIORITY||Odds Ratio (OR)|0.29||||0.19|TWO_SIDED||||||Regression, Logistic|||||||.19
91545833|NCT02119650|182970770|OTHER||Hazard Ratio (HR)|0.877||||0.7562|TWO_SIDED|80.0|0.509|1.51|||Log Rank|The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).||||1.51|0.509|0.7562
91545834|NCT02269475|182970778|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|100.0|||||TWO_SIDED|95.0|-1875.3|100.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||100.0|-1875.3|
91545835|NCT02269475|182970779|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|27.5|||||TWO_SIDED|95.0|7.4|43.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||43.0|7.4|
91545836|NCT01037985|182970791|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.168|TWO_SIDED|95.0|-10.4|1.9|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||1.9|-10.4|0.168
91545837|NCT01037985|182970792|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.858|TWO_SIDED|95.0|-3.5|4.2|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||4.2|-3.5|0.858
91545838|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.003|TWO_SIDED|95.0|-1.6|-0.4|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.6|0.003
91545839|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.067|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||0.0|-1.1|0.067
91545840|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.7|-2.1|<0.001
91545841|NCT01037985|182970793|SUPERIORITY||Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-1.4|-0.4|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.4|0.002
91545842|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.2|-1.3|0.007
91545843|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.214|TWO_SIDED|95.0|-1.1|0.3|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.3|-1.1|0.214
91545844|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.5|0.003
91545845|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.8|-2.2|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-2.2|-7.8|<0.001
91765366|NCT00413218|183419680|NON_INFERIORITY|The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.|Adjusted Treatment Difference (%)|-10.8|||||TWO_SIDED|95.0|-19.9|-1.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.||-1.8|-19.9|
91765367|NCT00413218|183419681|OTHER||Adjusted Treatment Difference (%)|-2.7|||||TWO_SIDED|95.0|-12.2|6.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||6.8|-12.2|
91765368|NCT00413218|183419682|OTHER||Adjusted Treatment Difference %|-10.9|||||TWO_SIDED|95.0|-19.9|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-19.9|
91545846|NCT01037985|182970793|SUPERIORITY||Mean Difference (Net)|0.1||||0.673|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||0.7|-0.5|0.673
91545847|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.276|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||1.1|-0.3|0.276
91545848|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.5|-0.7|0.670
91545849|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.5|0.5|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||0.5|-0.5|1.000
91545850|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.909|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.909
91545851|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.852|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.8|-0.6|0.852
91545852|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.906
91545853|NCT01037985|182970793|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.768|TWO_SIDED|95.0|-2.8|3.8|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.8|-2.8|0.768
91545854|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.773|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.5|-0.4|0.773
91545855|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.4|-0.4|1.000
91545856|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.072|TWO_SIDED|95.0|-1.4|0.1|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.1|-1.4|0.072
91545857|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.851|TWO_SIDED|95.0|-0.7|0.6|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.6|-0.7|0.851
91545858|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.184|TWO_SIDED|95.0|-1.2|0.2|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.2|0.184
91545859|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.059|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.059
91545860|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.04|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-1.5|0.040
91545861|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.12|TWO_SIDED|95.0|-4.1|0.5|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.5|-4.1|0.120
91545862|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.094|TWO_SIDED|95.0|-4.0|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-4.0|0.094
91545863|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.243|TWO_SIDED|95.0|-0.2|0.6|||t-test, 1 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.243
91545864|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.2|0.6|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.339
91545865|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.25|TWO_SIDED|95.0|-0.3|1.2|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||1.2|-0.3|0.250
91545866|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.164|TWO_SIDED|95.0|-1.3|0.2|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.3|0.164
91545867|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.8|-0.8|1.000
91545868|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.928
91545869|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.865|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.865
91545870|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.804|TWO_SIDED|95.0|-2.3|3.0|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.0|-2.3|0.804
91545871|NCT01037985|182970794|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.937|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||2.4|-2.6|0.937
91545872|NCT02730871|182970803|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
91545873|NCT02730871|182970804|OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
91545874|NCT02730871|182970805|OTHER||Mean Difference (Final Values)|-9.98|STANDARD_ERROR_OF_MEAN|1.572|<|0.001|TWO_SIDED|95.0|-13.1|-6.9|||ANCOVA|||||-6.9|-13.1|<0.001
91545875|NCT02730871|182970806|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.576||0.022|TWO_SIDED|95.0|-2.5|-0.2|||Repeated measures model|||Change from Baseline in IOP at 9:00||-0.2|-2.5|0.022
91545876|NCT02730871|182970806|OTHER||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|0.506|<|0.001|TWO_SIDED|95.0|-3.9|-1.9|||Repeated measures model|||Change from Baseline in IOP at 11:00||-1.9|-3.9|<0.001
91545877|NCT02730871|182970807|OTHER||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|2.567||0.018|TWO_SIDED|95.0|-11.2|-1.1|||Repeated measures model|||Percentage Change from Baseline in IOP at 09:00||-1.1|-11.2|0.018
91545878|NCT02730871|182970807|OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-17.8|-8.6|||Repeated measures model|||Percentage Change from Baseline in IOP at 11:00||-8.6|-17.8|<0.001
91545879|NCT05368558|182970816|SUPERIORITY||Mean Difference (Final Values)|9.6|||||TWO_SIDED|95.0|-4.0|23.1||||||||23.1|-4.0|
91545880|NCT05368558|182970816|SUPERIORITY||Mean Difference (Final Values)|-15.0|||||TWO_SIDED|95.0|-28.7|-1.4||||||||-1.4|-28.7|
91545881|NCT05368558|182970817|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.7|1.2||||||||1.2|-0.7|
91545882|NCT05368558|182970817|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.7|0.3||||||||0.3|-1.7|
91545883|NCT05368558|182970818|SUPERIORITY||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-2.5|7.5||||||||7.5|-2.5|
91545884|NCT05368558|182970818|SUPERIORITY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-8.0|0.0||||||||0.0|-8.0|
91545885|NCT05368558|182970819|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-8.9|9.7||||||||9.7|-8.9|
91545886|NCT05368558|182970819|SUPERIORITY||Mean Difference (Final Values)|-11.3|||||TWO_SIDED|95.0|-18.5|-4.1||||||||-4.1|-18.5|
91545887|NCT05368558|182970820|SUPERIORITY||Mean Difference (Final Values)|3.3|||||TWO_SIDED|95.0|-1.0|7.5||||||||7.5|-1.0|
91545888|NCT05368558|182970820|SUPERIORITY||Mean Difference (Final Values)|-4.6|||||TWO_SIDED|95.0|-8.9|-0.4||||||||-0.4|-8.9|
91545889|NCT05368558|182970821|SUPERIORITY||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-0.9|7.7||||||||7.7|-0.9|
91545890|NCT05368558|182970821|SUPERIORITY||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-10.2|-0.3||||||||-0.3|-10.2|
91545891|NCT01303445|182970839|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.03||||||90.0|86.95|97.4||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||97.40|86.95|
91545892|NCT01303445|182970839|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.3||||||90.0|87.76|97.08||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||97.08|87.76|
91545893|NCT01303445|182970840|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|96.38||||||90.0|90.96|102.13||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||102.13|90.96|
91765369|NCT00413218|183419682|OTHER||Adjusted Treatment Difference %|-5.4|||||TWO_SIDED|95.0|-15.0|4.2|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.2|-15.00|
91545894|NCT01303445|182970840|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|97.03||||||95.0|93.26|100.95||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||100.95|93.26|
91545895|NCT01303445|182970841|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.32|99.72||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.72|98.32|
91545896|NCT01303445|182970841|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|98.42||||||90.0|97.66|99.18||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.18|97.66|
91545897|NCT01303445|182970842|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|105.55||||||90.0|97.09|114.74||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||114.74|97.09|
91545898|NCT01303445|182970842|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|106.09||||||90.0|98.64|114.09||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||114.09|98.64|
91545899|NCT01303445|182970843|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.38||||||90.0|98.8|99.95||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.95|98.80|
91545900|NCT01303445|182970843|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.46|99.59||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.59|98.46|
91545901|NCT04870645|182970858|OTHER||||||<|0.05|||||||Statistical Significance|||||||< 0.05
91545902|NCT01259401|182970868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
91545903|NCT01259401|182970869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.061|TWO_SIDED||||||ANCOVA|||||||.061
91545904|NCT04924062|182970870|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.51|1.08|||||HR=Arm A/Arm B|||1.08|0.51|
91765370|NCT00413218|183419683|OTHER||Adjusted Treatment Difference (%)|-8.2|||||TWO_SIDED|95.0|-15.4|-0.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.9|-15.4|
91545905|NCT04924062|182970871|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.58|1.19|||||HR=Arm A/Arm B|||1.19|0.58|
91545906|NCT04924062|182970872|OTHER||Difference in Percentages|7.1|||||TWO_SIDED|95.0|-7.5|21.6|||||Difference=Arm A minus Arm B|||21.6|-7.5|
91545907|NCT05768373|182970876|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-3.4|4.0|||||The difference is 3M Clinpro minus 3M Vanish.|||4.0|-3.4|
91545908|NCT05768373|182970877|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.6|5.3|||||The difference is 3M Clinpro minus 3M Vanish.|||5.3|-2.6|
91545909|NCT05768373|182970878|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-3.2|6.7|||||The difference is 3M Clinpro minus 3M Vanish.|||6.7|-3.2|
91545910|NCT05768373|182970879|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.0|7.4|||||The difference is 3M Clinpro minus 3M Vanish.|||7.4|-3.0|
91545911|NCT05768373|182970880|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-4.4|8.2|||||The difference is 3M Clinpro minus 3M Vanish.|||8.2|-4.4|
91545912|NCT05478525|182970882|SUPERIORITY||Least Squares (LS) Mean Difference|-35.05||||0.0007|TWO_SIDED|95.0|-54.35|-15.75|||ANCOVA|||Analysis at Week 2||-15.75|-54.35|0.0007
91545913|NCT05478525|182970882|SUPERIORITY||LS Mean Difference|-23.14||||0.0193|TWO_SIDED|95.0|-42.32|-3.97|||ANCOVA|||Analysis at Week 2||-3.97|-42.32|0.0193
91545914|NCT05478525|182970882|SUPERIORITY||LS Mean Difference|-21.64||||0.0243|TWO_SIDED|95.0|-40.33|-2.96|||ANCOVA|||Analysis at Week 2||-2.96|-40.33|0.0243
91545915|NCT05478525|182970884|SUPERIORITY||LS Mean Difference|-155.68||||0.0298|TWO_SIDED|95.0|-295.35|-16.01|||ANCOVA|||Analysis at Day 14||-16.01|-295.35|0.0298
91545916|NCT05478525|182970884|SUPERIORITY||LS Mean Difference|-143.74||||0.0433|TWO_SIDED|95.0|-282.92|-4.55|||ANCOVA|||Analysis at Day 14||-4.55|-282.92|0.0433
91545917|NCT05478525|182970884|SUPERIORITY||LS Mean Difference|-178.33||||0.0201|TWO_SIDED|95.0|-327.16|-29.5|||ANCOVA|||Analysis at Day 14||-29.50|-327.16|0.0201
91545918|NCT05478525|182970885|SUPERIORITY||LS Mean Difference|-47.07||||0.1992|TWO_SIDED|95.0|-119.94|25.81|||ANCOVA|||Analysis at Day 14||25.81|-119.94|0.1992
91545919|NCT05478525|182970885|SUPERIORITY||LS Mean Difference|-70.32||||0.0617|TWO_SIDED|95.0|-144.26|3.61|||ANCOVA|||Analysis at Day 14||3.61|-144.26|0.0617
91545920|NCT05478525|182970885|SUPERIORITY||LS Mean Difference|-39.84||||0.2981|TWO_SIDED|95.0|-116.22|36.53|||ANCOVA|||Analysis at Day 14||36.53|-116.22|0.2981
91545921|NCT05644002|182970893|OTHER||Mean Difference (Final Values)|2.06||||0.71|TWO_SIDED|95.0|-9.09|13.21||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||13.21|-9.09|.71
91545922|NCT05644002|182970893|OTHER||t-statistic|0.369|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.||||
91545923|NCT05644002|182970893|OTHER||Hedge's g|0.09|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||||
91545924|NCT05644002|182970894|OTHER||Mean Difference (Final Values)|0.251||||0.53|TWO_SIDED|95.0|-0.543|1.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||1.046|-.543|.530
91545925|NCT05644002|182970894|OTHER||t-statistic|0.631|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
91545926|NCT05644002|182970894|OTHER||Hedge's g|0.14|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
91545927|NCT05644002|182970895|OTHER||Mean Difference (Final Values)|0.889||||0.66|TWO_SIDED|95.0|-3.149|4.927||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.||4.927|-3.149|.66
91545928|NCT05644002|182970895|OTHER||t-statistic|0.439|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions.||||
91545929|NCT05644002|182970895|OTHER||Hedge's g|-0.11|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions.||||
91545930|NCT05644002|182970896|OTHER||Mean Difference (Final Values)|-0.698||||0.77|TWO_SIDED|95.0|-5.443|4.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||4.046|-5.443|.77
91545931|NCT05644002|182970896|OTHER||t-statistic|-0.294|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions.||||
91545932|NCT05644002|182970896|OTHER||Hedge's g|-0.071|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||||
91545933|NCT05644002|182970897|OTHER||Mean Difference (Final Values)|-0.354||||0.9|TWO_SIDED|95.0|-6.009|5.3||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||5.300|-6.009|.90
91545934|NCT05644002|182970897|OTHER||t-statistic|-0.125|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions.||||
91545935|NCT05644002|182970897|OTHER||Hedge's g|-0.03|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||||
91545936|NCT05644002|182970898|OTHER||Mean Difference (Final Values)|-0.748||||0.09|TWO_SIDED|95.0|-1.601|0.105||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||.105|-1.601|.09
91545937|NCT05644002|182970898|OTHER||t-statistic|-1.75|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 65.261||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||||
91545938|NCT05644002|182970898|OTHER||Hedge's g|-0.405|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions.||||
91545939|NCT05644002|182970899|OTHER||Mean Difference (Final Values)|0.184||||0.666|TWO_SIDED|95.0|-0.663|1.031||The threshold for statistical significance was p\<.05|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||1.031|-.663|.666
91545940|NCT05644002|182970899|OTHER||t-statistic|0.184|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||||
91545941|NCT05644002|182970899|OTHER||Hedge's g|0.099|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions.||||
91545942|NCT05644002|182970900|OTHER||β|0.026||||0.73|TWO_SIDED|95.0|-0.358|0.507||The threshold for statistical significance was p\<.05.|Regression, Linear|Coding: Control=0, PTBT=1.||A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress-induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrhythmia at step 1 of the model.||.507|-.358|.73
91545943|NCT05644002|182970900|OTHER||t-statistic|0.345|||||TWO_SIDED||||||Regression, Linear|degrees freedom = (2, 73)|Condition (0=control; 1=PTBT)|A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrythmia at step 1 of the model.||||
91545944|NCT05644002|182970901|OTHER||Mean Difference (Final Values)|-0.543||||0.001|TWO_SIDED|95.0|-0.772|-0.314||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \< .05, equal variances are not assumed and reported results are adjusted accordingly.||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||-.314|-.772|.001
91545945|NCT05644002|182970901|OTHER||t-statistic|-4.739|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66.03||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||||
91545946|NCT05644002|182970901|OTHER||Hedge's g|-1.05|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions.||||
91545947|NCT04038957|182970979|SUPERIORITY|||||||0.0072||||||A p-value of p\<0.05 will be considered as significant.|Repeated Measures ANOVA|||To examine the primary outcome, the effects of SEP-363856 on the striatum, a repeated measures ANOVA model will be build using the baseline and on-treatment kicer values of each striatal subregion.||||0.0072
91545948|NCT02605837|182970981|SUPERIORITY||Difference in proportion of responders|0.52|||<|0.001||95.0|0.433|0.591|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.591|0.433|<0.001
91545949|NCT02605837|182970982|SUPERIORITY||Difference in proportion of responders|0.13||||0.024||95.0|0.016|0.243|||Cochran-Mantel-Haenszel|||The CMH adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.243|0.016|0.024
91545950|NCT02605837|182970983|SUPERIORITY||Difference in Least square mean|-3.92||||0.015||95.0|-7.073|-0.774|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ combined score as a continuous covariate.||-0.774|-7.073|0.015
91545951|NCT02605837|182970984|SUPERIORITY||Difference in Least square mean|-1.8|||<|0.001||95.0|-2.6|-1.1|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline. Total EREFS (endoscopy score) as a continuous covariate.||-1.1|-2.6|<0.001
91545952|NCT02605837|182970985|SUPERIORITY||Odds Ratio (OR)|169.74|||<|0.001||95.0|23.235|1239.979|||Regression, Logistic|||Peak eosinophil count (\<15/HPF) was performed based on logistic regression model adjusted for age group and diet restriction.||1239.979|23.235|<0.001
91545953|NCT02605837|182970985|SUPERIORITY||Odds Ratio (OR)|100.69||||0.001|TWO_SIDED|95.0|6.294|1610.749|||Firth logistic regression|||Peak eosinophil count (\<=1/HPF) was performed based on firth logistic regression model adjusted for age group and diet restriction.||1610.749|6.294|0.001
91545954|NCT02605837|182970986|SUPERIORITY||Difference in Least square mean|-28.4|||<|0.001||95.0|-35.0|-21.8|||ANCOVA|||This analysis of proximal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-21.8|-35.0|<0.001
91545955|NCT02605837|182970986|SUPERIORITY||Difference in Least square mean|-30.4|||<|0.001||95.0|-38.1|-22.7|||ANCOVA|||This analysis of mid eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-22.7|-38.1|<0.001
91545956|NCT02605837|182970986|SUPERIORITY||Difference in Least square mean|-33.1|||<|0.001||95.0|-40.7|-25.5|||ANCOVA|||This analysis of distal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate||-25.5|-40.7|<0.001
91545957|NCT02605837|182970986|SUPERIORITY||Difference in LS Mean|-47.6|||<|0.001|TWO_SIDED|95.0|-56.4|-38.8|||ANCOVA|||This analysis of maximum eosinophil count was from the ANCOVA model with treatment group and age group as factors and the baseline Peak eosinophil count as a continuous covariate.||-38.8|-56.4|<0.001
91545958|NCT02605837|182970987|SUPERIORITY||Difference in Least square mean|-0.19|||<|0.001||95.0|-0.22|-0.16|||ANCOVA|||This analysis of histopathologic epithelial features combined grade TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.16|-0.22|<0.001
91765371|NCT00413218|183419683|OTHER||Adjusted Treatment Difference (%)|-8.6|||||TWO_SIDED|95.0|-15.8|-1.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.5|-15.8|
91765372|NCT00413218|183419683|OTHER||Adjusted Treatment Difference (%)|-0.4|||||TWO_SIDED|95.0|-9.1|8.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||8.3|-9.1|
91545959|NCT02605837|182970987|SUPERIORITY||Difference in Least square mean|-0.2|||<|0.001||95.0|-0.2|-0.2|||ANCOVA|||This analysis of histopathologic epithelial features combined stage TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.2|-0.2|<0.001
91545960|NCT02605837|182970988|SUPERIORITY||Odds Ratio (OR)|1.42||||0.164|TWO_SIDED|95.0|0.866|2.333|||Regression, Logistic|||Dysphagia symptom response (binary response) at the final treatment period was performed based on logistic regression model adjusted for age group and diet restriction.||2.333|0.866|0.164
91545961|NCT02605837|182970989|SUPERIORITY||Odds Ratio (OR)|91.86||||0.001|TWO_SIDED|95.0|5.687|1483.68|||Firth logistic regression|||Overall binary response I at the final treatment period was performed based on firth logistic regression model adjusted for age group and diet restriction.||1483.680|5.687|0.001
91545962|NCT02605837|182970990|SUPERIORITY||Odds Ratio (OR)|61.68||||0.004|TWO_SIDED|95.0|3.836|991.858|||Firth logistic regression|||Overall binary response II at the final treatment period was perfomed based on based on firth logistic regression model adjusted for age group and diet restriction.||991.858|3.836|0.004
91545963|NCT02605837|182970991|SUPERIORITY||Difference in Least square mean|-6.41||||0.004||95.0|-10.757|-2.063|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ + Pain score as a continuous covariate.||-2.063|-10.757|0.004
91545964|NCT02605837|182970992|SUPERIORITY||Difference in Least square mean|-2.46||||0.002||95.0|-4.018|-0.909|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ Pain score as a continuous covariate.||-0.909|-4.018|0.002
91545965|NCT04491968|182971009|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.02|TWO_SIDED|95.0|0.37|0.9|||proportional hazard regression|||||.90|.37|.02
91545966|NCT04491968|182971010|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.04|TWO_SIDED|95.0|0.18|0.96|||proportional hazard regression|||||.96|.18|.04
91545967|NCT05656911|182971027|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0|-29.0|18.0|||||Posterior probability is 34.0%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||18.0|-29.0|
91545968|NCT05656911|182971028|OTHER||Mean Difference (Final Values)|11.31||||0.257|TWO_SIDED|95.0|-8.26|30.87||two-sided. No adjustment for multiple comparisons.|ANCOVA||LS mean (%)|The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||30.87|-8.26|0.257
91545969|NCT05656911|182971029|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-27.0|22.1|||||Posterior probability is 41.7%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||22.1|-27.0|
91545970|NCT05656911|182971030|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-4.6|||||TWO_SIDED|95.0|-25.6|13.4|||||Posterior probability is 31.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||13.4|-25.6|
91545971|NCT05656911|182971031|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-12.5|||||TWO_SIDED|95.0|-34.1|7.0|||||Posterior probability is 10.8%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||7.0|-34.1|
91545972|NCT05656911|182971032|OTHER||Mean Difference (Final Values)|7.06||||0.166|TWO_SIDED|95.0|-2.92|17.03||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||17.03|-2.92|0.166
91545973|NCT05656911|182971033|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-8.4|||||TWO_SIDED|95.0|-30.4|11.0|||||Posterior probability is 20.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||11.0|-30.4|
91545974|NCT05656911|182971035|OTHER||Mean Difference (Final Values)|6.68||||0.396|TWO_SIDED|95.0|-8.75|22.11||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||22.11|-8.75|0.396
91545975|NCT03547908|182971037|NON_INFERIORITY|A sample size of 240 participants randomized in a 1:1 ratio to 2 treatment groups, achieved 90% power to detect a non-inferiority margin of 12% between the 2 treatment groups. For the sample size and power computation, it is assumed that both treatment groups have a response rate of 91% (based on Gilead Studies GS-US-380-1489 and GS-US-380-1490), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|4.1|||||TWO_SIDED|95.001|-2.5|10.8|||||The difference in percentages of participants between groups and their 95.001% confidence intervals (CI)s were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||10.8|-2.5|
91765373|NCT00413218|183419683|OTHER||Adjusted Treatment Difference (%)|-5.8|||||TWO_SIDED|95.0|-15.3|3.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||3.6|-15.3|
91765374|NCT00413218|183419684|OTHER||Adjusted Treatment Difference (%)|-14.9|||||TWO_SIDED|95.0|-22.7|-7.0|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-7.0|-22.7|
91545976|NCT03547908|182971037|SUPERIORITY|||||||0.2113|||||||Cochran-Mantel-Haenszel|The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).||||||0.2113
91545977|NCT03547908|182971038|NON_INFERIORITY|A sample size of 240 participants provided 81% power to detect a non-inferiority margin of 12% between the 2 treatment groups. This assumed that both treatment groups have a response rate of 88% (based on Gilead Studies GS-US-320-0108 and GS-US-320-0110), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|16.6|||||TWO_SIDED|95.001|5.9|27.3|||||||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95.001% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|27.3|5.9|
91545978|NCT03547908|182971038|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|The p-value was from CMH test stratified by baseline HBeAg status (positive vs negative) and HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||||||0.0023
91545979|NCT03547908|182971039|SUPERIORITY||Difference in Percentages|-0.3||||0.9427|TWO_SIDED|95.0|-8.9|8.3||P-value for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups was from the CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||8.3|-8.9|0.9427
91545980|NCT03547908|182971040|OTHER||Difference in least squares mean (LSM)|24.0||||0.1701|TWO_SIDED|95.0|-10.0|58.0|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||58|-10|0.1701
91545981|NCT03547908|182971041|OTHER||Difference in Least Squares Means|30.0||||0.1853|TWO_SIDED|95.0|-14.0|74.0||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||74|-14|0.1853
91545982|NCT03547908|182971042|OTHER||Difference in least squares mean (LSM)|0.59||||0.2839|TWO_SIDED|95.0|-0.49|1.67|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||1.67|-0.49|0.2839
91545983|NCT03547908|182971043|OTHER||Difference in LSM|0.13||||0.8456|TWO_SIDED|95.0|-1.2|1.46||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in LSM and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||1.46|-1.20|0.8456
91545984|NCT03547908|182971044|SUPERIORITY|P-value for the superiority test comparing the percentages of participants with HBV DNA \< 29 IU/mL between treatment groups was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in Percentages|2.6||||0.6367|TWO_SIDED|95.0|-8.3|13.4|||Cochran-Mantel-Haenszel|||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||13.4|-8.3|0.6367
91545985|NCT03547908|182971045|OTHER||Difference in Percentages|17.1||||0.0655|TWO_SIDED|95.0|-1.5|35.7|||Cochran-Mantel-Haenszel|P-value was calculated from CMH tests stratified by baseline HBeAg status (positive vs negative) and HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|The difference in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||35.7|-1.5|0.0655
91545986|NCT03547908|182971046|OTHER||Difference in Percentages|14.1||||0.1253|TWO_SIDED|95.0|-4.3|32.6|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|Difference in the proportion between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|||32.6|-4.3|0.1253
91545987|NCT03547908|182971047|OTHER||Difference in Percentages|7.1||||0.0591|TWO_SIDED|95.0|-0.8|15.0|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative)and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in the percentages between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||15.0|-0.8|0.0591
91545988|NCT03547908|182971048|OTHER||Difference in Percentages|9.3||||0.0655|TWO_SIDED|95.0|-0.7|19.2||P value was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL). Statistically significant values are shown in bold.|Cochran-Mantel-Haenszel||Differences in percentages between treatment groups and their 95% CI were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||19.2|-0.7|0.0655
91545989|NCT02349412|182971055|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.104|TWO_SIDED|95.0|-0.67|7.13|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.13|-0.67|0.104
91545990|NCT02349412|182971056|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.188|TWO_SIDED|95.0|-1.54|7.77|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.77|-1.54|0.188
91545991|NCT02349412|182971057|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.884|TWO_SIDED|95.0|-0.94|2.09|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score||||2.09|-0.94|0.884
91545992|NCT02349412|182971058|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.033|TWO_SIDED|95.0|-1.54|-0.07|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score||||-0.07|-1.54|0.033
91545993|NCT02349412|182971059|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
91545994|NCT00567398|182971067|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
91545995|NCT00567398|182971067|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
91545996|NCT00567398|182971068|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
91545997|NCT00567398|182971068|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
91545998|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
91545999|NCT00567398|182971070|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
91546000|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
91546001|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
91546002|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
91546003|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
91546004|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
91546005|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
91546006|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
91546007|NCT00567398|182971070|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
91546008|NCT00567398|182971071|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
91546009|NCT00567398|182971071|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
91546010|NCT00567398|182971071|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
91546011|NCT00567398|182971071|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
91546012|NCT00567398|182971071|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
91546013|NCT00567398|182971071|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
91546014|NCT00567398|182971072|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
91546015|NCT00567398|182971072|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
91546016|NCT00567398|182971072|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
91546017|NCT00567398|182971072|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
91546018|NCT00567398|182971073|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
91546019|NCT00567398|182971073|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
91546020|NCT00567398|182971074|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
91546021|NCT00567398|182971075|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
91546022|NCT00567398|182971075|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
91546023|NCT00567398|182971075|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
91546024|NCT00567398|182971075|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
91546025|NCT00567398|182971076|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
91546026|NCT00567398|182971076|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
91546027|NCT00567398|182971076|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
91546028|NCT00567398|182971076|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
91546029|NCT00567398|182971077|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
91546030|NCT00567398|182971077|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
91546031|NCT00567398|182971078|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
91546032|NCT00567398|182971078|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
91546033|NCT00567398|182971079|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
91546034|NCT00567398|182971079|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
91546035|NCT00567398|182971080|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
91546036|NCT00567398|182971081|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
91546037|NCT00567398|182971081|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
91546038|NCT00567398|182971081|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
91546039|NCT00567398|182971081|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
91546040|NCT00567398|182971082|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
91546041|NCT00567398|182971082|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
91546042|NCT00567398|182971083|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
91546043|NCT00567398|182971083|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
91546044|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
91546045|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
91546046|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
91546047|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
91546048|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
91546049|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
91546050|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
91546051|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
91546052|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
91546053|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
91546054|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
91546055|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
91546056|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
91546057|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
91546058|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
91546059|NCT00567398|182971084|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
91546060|NCT00567398|182971085|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
91546061|NCT00567398|182971085|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
91546062|NCT00567398|182971086|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
91546063|NCT00567398|182971086|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
91546064|NCT00567398|182971087|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
91546065|NCT00567398|182971087|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
91546066|NCT00567398|182971088|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
91546067|NCT03517553|182971089|SUPERIORITY|||||||0.999||||||Threshold for statistical significance is P\<0.05|Kruskal-Wallis|||||||0.999
91546068|NCT03517553|182971089|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
91546069|NCT03517553|182971090|SUPERIORITY|||||||0.869|||||||Kruskal-Wallis|||||||0.869
91546070|NCT03517553|182971090|SUPERIORITY|||||||0.813|||||||Kruskal-Wallis|||||||0.813
91546071|NCT03517553|182971090|SUPERIORITY|||||||0.978|||||||Kruskal-Wallis|||||||0.978
91546072|NCT03517553|182971090|SUPERIORITY|||||||0.731|||||||Kruskal-Wallis|||||||0.731
91546073|NCT03517553|182971090|SUPERIORITY|||||||0.703|||||||Kruskal-Wallis|||||||0.703
91546074|NCT03517553|182971090|SUPERIORITY|||||||0.909|||||||Kruskal-Wallis|||||||0.909
91546075|NCT02201108|182971107|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.2949|TWO_SIDED|95.0|0.388|1.113||Threshold for significance was \< 0.05.|Stratified Log-Rank test|P-value derived from log-rank test with stratification of region and pubertal status.|Hazard ratio was estimated using a Cox proportional-hazards model with factors for treatment group, region, pubertal status, age, and number of relapses in the year prior to randomization as covariates and with robust variance estimation.|||1.113|0.388|0.2949
91546076|NCT02201108|182971109|OTHER||Relative risk ratio|0.511|||||TWO_SIDED|95.0|0.343|0.762||||||||0.762|0.343|
91546077|NCT02201108|182971110|OTHER||Relative risk ratio|0.57|||||TWO_SIDED|95.0|0.331|0.983||||||||0.983|0.331|
91546078|NCT02201108|182971113|OTHER||Relative risk ratio|0.498|||||TWO_SIDED|95.0|0.296|0.836||||||||0.836|0.296|
91546079|NCT02201108|182971127|OTHER||Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.37|1.296|||||Hazard ratio estimated using a Cox proportional-hazards model using treatment group, region, pubertal status, age, and number of relapses in the year prior to randomisation as covariates and with robust variance estimation.|||1.296|0.37|
91546080|NCT04143061|182971137|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|6.55|||||TWO_SIDED|95.0|2.03|11.08||||||Statistical analysis for Serogroup A||11.08|2.03|
91546081|NCT04143061|182971137|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|21.67|||||TWO_SIDED|95.0|17.82|25.8||||||Statistical analysis for Serogroup C||25.80|17.82|
91546082|NCT04143061|182971137|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.08|||||TWO_SIDED|95.0|7.43|14.89||||||Statistical analysis for Serogroup Y||14.89|7.43|
91546083|NCT04143061|182971137|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.01|||||TWO_SIDED|95.0|7.86|14.47||||||Statistical analysis for Serogroup W||14.47|7.86|
91546084|NCT03289039|182971147|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.98|TWO_SIDED|95.0|0.27|4.12|||Log Rank|||||4.12|0.27|0.98
91546085|NCT03289039|182971148|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.89|TWO_SIDED|95.0|0.24|2.81|||Log Rank|||||2.81|0.24|0.89
91546086|NCT04761302|182971156|SUPERIORITY|||||||0.215||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.215
91546087|NCT04761302|182971156|SUPERIORITY|||||||0.445||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.445
91546088|NCT04761302|182971157|SUPERIORITY|||||||0.041||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.041
91546089|NCT04761302|182971157|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.300
91546090|NCT04761302|182971158|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.12
91546091|NCT04761302|182971158|SUPERIORITY|||||||0.359||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.359
91546092|NCT04761302|182971159|SUPERIORITY|||||||0.083||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.083
91546093|NCT04761302|182971159|SUPERIORITY|||||||0.152||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.152
91546094|NCT04761302|182971160|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
91546095|NCT04761302|182971160|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
91546096|NCT04761302|182971161|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
91546097|NCT04761302|182971161|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
91546098|NCT04761302|182971162|SUPERIORITY|||||||0.004||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.004
91546099|NCT04761302|182971162|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
91546100|NCT04761302|182971163|SUPERIORITY|||||||0.006||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.006
91546101|NCT04761302|182971163|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
91546102|NCT04761302|182971164|SUPERIORITY|||||||0.354||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.354
91546103|NCT04761302|182971164|SUPERIORITY|||||||0.455||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.455
91546104|NCT02991534|182971167|SUPERIORITY||Odds Ratio (OR)|1.09||||0.003|TWO_SIDED|95.0|1.03|1.152|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.152|1.030|.003
91546105|NCT02991534|182971168|SUPERIORITY||Odds Ratio (OR)|1.0||||0.91|TWO_SIDED|95.0|0.976|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|0.976|0.91
91546106|NCT02991534|182971169|SUPERIORITY||Odds Ratio (OR)|1.06||||0.265|TWO_SIDED|95.0|0.959|1.165|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.165|.959|.265
91546107|NCT02991534|182971170|SUPERIORITY||Odds Ratio (OR)|1.01||||0.015|TWO_SIDED|95.0|1.002|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|1.002|0.015
91546108|NCT03144518|182971190|SUPERIORITY||Partial Eta Squared|0.079||||0.005|TWO_SIDED|90.0|0.014|0.173||ANCOVA, controlling for pre-intervention levels|ANCOVA|ANCOVA, controlling for pre-intervention levels||VAS-Valence Scores||.173|.014|.005
91546109|NCT03144518|182971190|SUPERIORITY||Partial Eta-Squared|0.04||||0.047|TWO_SIDED|90.0|0.0|0.12|||ANCOVA|Controlling for pre-intervention scores||VAS-Arousal Scores||.120|.000|.047
91546110|NCT03144518|182971190|SUPERIORITY||Partial Eta Squared|0.096||||0.002|TWO_SIDED|90.0|0.022|0.196|||ANCOVA|Controlling for pre-intervention levels||Pictorial Scale||.196|.022|.002
91546111|NCT03144518|182971190|SUPERIORITY||Partial Eta Squared|0.002||||0.697|TWO_SIDED|90.0|0.0|0.036|||ANCOVA|Controlling for baseline levels||PANAS Positive Affect Scores||.036|.000|.697
91546112|NCT03144518|182971190|SUPERIORITY||Partial Eta Squared|0.005||||0.462|TWO_SIDED|90.0|0.0|0.053|||ANCOVA|||PANAS Negative Affect Scores||.053|.000|.462
91546113|NCT03144518|182971193|SUPERIORITY||Partial Eta Squared|0.001||||0.806|TWO_SIDED|90.0|0.0|0.031|||ANCOVA|Controlling for pre-intervention levels||||.031|.000|.806
91546114|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.006||||0.438|TWO_SIDED|90.0|0.0|0.055|||ANCOVA|Controlling for Pre-Vaccination levels||4 Weeks A/Hong-Kong||.055|.000|.438
91546115|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.004||||0.516|TWO_SIDED|90.0|0.0|0.051|||ANCOVA|controlling for pre-vaccination levels||A/Hong-Kong 16 Weeks Post-Vaccination||.051|.000|.516
91546116|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.002||||0.671|TWO_SIDED|90.0|0.0|0.038|||ANCOVA|controlling for pre-vaccination levels||A/Michigan 4 weeks post-vaccination||.038|.000|.671
91546117|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.0||||0.98|TWO_SIDED|90.0|0.0|0.0|||ANCOVA|Controlling for pre-vaccination levels||A/Michigan 16 weeks post-vaccination||.000|.000|.980
91546118|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.409|TWO_SIDED|90.0|0.0|0.057|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 4 weeks post-vaccination||.057|.000|.409
91546119|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.008||||0.377|TWO_SIDED|90.0|0.0|0.062|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 16 weeks post-vaccination||.062|.000|.377
91546120|NCT03144518|182971194|SUPERIORITY||Partial Eta Squared|0.0||||0.892|TWO_SIDED|90.0|0.0|0.008|||ANCOVA|Controlling for pre-vaccination levels||B/Phuket 4 weeks post-vaccination||.008|.000|.892
91546121|NCT03144518|182971194|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.426|TWO_SIDED|90.0|0.0|0.058|||ANCOVA|Controlling for pre-vaccination levels||||.058|.000|.426
91546122|NCT01989455|182971214|SUPERIORITY_OR_OTHER||Percent ratio|73.19|||||TWO_SIDED|90.0|68.83|77.56||||||||77.56|68.83|
91546123|NCT00632203|182971216|SUPERIORITY_OR_OTHER|||||||0.6995|||||||2-sided Exact Pearson Chi-square Test|||||||0.6995
91546124|NCT00448669|182971224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Regression, Cox|||Safety analyses were performed in the intention-to-treat cohort. Primary safety end points included the frequency of adverse clinical or laboratory events.||||0.003
91546125|NCT00448669|182971225|SUPERIORITY_OR_OTHER_LEGACY||Efficacy|62.2||||0.03|TWO_SIDED|95.0|21.5|83.4|||Regression, Cox|||The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The primary hypothesis was that TDF-FTC, as compared with placebo, would reduce the rate of HIV infection by at least 65%, with a predefined lower boundary for the 95% confidence interval of 10%.||83.4|21.5|0.03
91546126|NCT00448669|182971226|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Regression, Logistic|In this univariate model with the analysis of number of condomless sex acts, our model estimates the odds of reporting no condomless sex acts.||"A logistic regression was used to estimate the odds of reporting zero condomless sex acts. The longitudinal dependent variable (number of condomless sex acts) was defined as:~Number of condomless vaginal sexual acts with both casual and main partners among those who reported having had at least one sexual partner in the previous 30 days."||1.28|1.05|0.004
91546127|NCT00448669|182971227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Fisher Exact|||Fisher's Exact Test was performed to test for differences between the treatment groups in terms of adherence based on pill count.||||0.79
91546128|NCT02638337|182971251|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.7|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||For the percentage of parabasal cells a mixed-effects model for repeated measures (MMRM) approach was used, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||-18.0|-25.7|<0.0001
91546129|NCT02638337|182971252|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.2|9.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||9.1|5.2|<0.0001
91546130|NCT02638337|182971253|SUPERIORITY||LS Mean Difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.59|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||-0.59|-0.84|<0.0001
91546131|NCT02638337|182971254|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.62|3.06|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|For the MBS of vaginal dryness a generalized estimating equations (GEE) model was used to fit a marginal proportional odds model to the longitudinal ordered categorical data, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline severity of dryness modeled as a covariate.||3.06|1.62|<0.0001
91546132|NCT02638337|182971256|SUPERIORITY||LS Mean Difference|-21.6|||<|0.0001|TWO_SIDED|95.0|-25.2|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-18.0|-25.2|<0.0001
91546133|NCT02638337|182971256|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.4|-18.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-18.1|-25.4|<0.0001
91546134|NCT02638337|182971257|SUPERIORITY||LS Mean Difference|5.8|||<|0.0001|TWO_SIDED|95.0|4.2|7.3|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||7.3|4.2|<0.0001
91546135|NCT02638337|182971257|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.5|9.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||9.0|5.5|<0.0001
91546136|NCT02638337|182971258|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.46|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-0.46|-0.69|<0.0001
91546137|NCT02638337|182971258|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.51|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-0.51|-0.75|<0.0001
91546138|NCT02638337|182971259|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0005|TWO_SIDED|95.0|1.27|2.36|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.36|1.27|0.0005
91546139|NCT02638337|182971259|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.47|2.74|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.74|1.47|<0.0001
91546140|NCT02638337|182971260|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6263|TWO_SIDED|95.0|0.55|1.43|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.43|0.55|0.6263
91546141|NCT02638337|182971260|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.66|1.75|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||1.75|0.66|0.7869
91546142|NCT02638337|182971260|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8894|TWO_SIDED|95.0|0.65|1.64|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.64|0.65|0.8894
91546143|NCT02638337|182971261|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8369|TWO_SIDED|95.0|0.4|2.1|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.10|0.40|0.8369
91546144|NCT02638337|182971261|SUPERIORITY||Odds Ratio (OR)|1.51||||0.397|TWO_SIDED|95.0|0.58|3.95|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||3.95|0.58|0.3970
91546145|NCT02638337|182971261|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5391|TWO_SIDED|95.0|0.54|3.26|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||3.26|0.54|0.5391
91546146|NCT02638337|182971262|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0095|TWO_SIDED|95.0|1.13|2.4|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.40|1.13|0.0095
91546147|NCT02638337|182971262|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0542|TWO_SIDED|95.0|0.99|2.11|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.11|0.99|0.0542
91546148|NCT02638337|182971262|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0004|TWO_SIDED|95.0|1.35|2.88|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||2.88|1.35|0.0004
91546149|NCT02638337|182971263|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4336|TWO_SIDED|95.0|0.3|1.67|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.67|0.30|0.4336
91546150|NCT02638337|182971263|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7672|TWO_SIDED|95.0|0.37|2.08|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.08|0.37|0.7672
91546151|NCT02638337|182971263|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7101|TWO_SIDED|95.0|0.39|1.89|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.89|0.39|0.7101
91546152|NCT02638337|182971264|SUPERIORITY||LS Mean Difference|13.98|||<|0.0001|TWO_SIDED|95.0|11.85|16.12|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||16.12|11.85|<0.0001
91546153|NCT02638337|182971264|SUPERIORITY||LS Mean Difference|14.73|||<|0.0001|TWO_SIDED|95.0|12.5|16.96|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||16.96|12.50|<0.0001
91546154|NCT02638337|182971264|SUPERIORITY||LS Mean Difference|14.91|||<|0.0001|TWO_SIDED|95.0|12.55|17.28|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||17.28|12.55|<0.0001
91546155|NCT02638337|182971265|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 4||||<0.0001
91546156|NCT02638337|182971265|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 8||||<0.0001
91546157|NCT02638337|182971265|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 12||||<0.0001
91546158|NCT02638337|182971266|SUPERIORITY||LS Mean Difference|2.5|||<|0.0001|TWO_SIDED|95.0|2.0|3.0|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||3.0|2.0|<0.0001
91546159|NCT02638337|182971266|SUPERIORITY||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|2.4|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||3.4|2.4|<0.0001
91546160|NCT02638337|182971266|SUPERIORITY||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|2.2|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.4|2.2|<0.0001
91546161|NCT02638337|182971267|SUPERIORITY||LS Mean Difference|-0.8||||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||-0.4|-1.3|0.0002
91546162|NCT02638337|182971267|SUPERIORITY||LS Mean Difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||-0.6|-1.5|<0.0001
91546163|NCT02638337|182971267|SUPERIORITY||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||-0.7|-1.6|<0.0001
91546164|NCT02638337|182971268|SUPERIORITY||LS Mean Difference|-1.0||||0.0118|TWO_SIDED|95.0|-1.8|-0.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.2|-1.8|0.0118
91546165|NCT02638337|182971269|SUPERIORITY||LS Mean Difference|0.02||||0.9748|TWO_SIDED|95.0|-1.17|1.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||1.20|-1.17|0.9748
91546166|NCT02638337|182971269|SUPERIORITY||LS Mean Difference|0.19||||0.7865|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||1.56|-1.18|0.7865
91546167|NCT02638337|182971269|SUPERIORITY||LS Mean Difference|1.59||||0.0392|TWO_SIDED|95.0|0.08|3.09|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.09|0.08|0.0392
91546168|NCT02638337|182971270|SUPERIORITY||LS Mean Difference|0.16||||0.0752|TWO_SIDED|95.0|-0.02|0.34|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Desire||0.34|-0.02|0.0752
91546169|NCT02638337|182971270|SUPERIORITY||LS Mean Difference|0.2||||0.1867|TWO_SIDED|95.0|-0.1|0.49|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Arousal||0.49|-0.10|0.1867
91546170|NCT02638337|182971270|SUPERIORITY||LS Mean Difference|0.4||||0.0161|TWO_SIDED|95.0|0.07|0.73|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Lubrication||0.73|0.07|0.0161
91546171|NCT02638337|182971270|SUPERIORITY||LS Mean Difference|0.16||||0.34|TWO_SIDED|95.0|-0.16|0.48|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Orgasm||0.48|-0.16|0.3400
91546172|NCT02638337|182971270|SUPERIORITY||LS Mean Difference|0.16||||0.2195|TWO_SIDED|95.0|-0.1|0.41|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Satisfaction||0.41|-0.10|0.2195
91546173|NCT02638337|182971270|SUPERIORITY||LS Mean Difference|0.45||||0.0103|TWO_SIDED|95.0|0.11|0.8|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Pain||0.80|0.11|0.0103
91546174|NCT02638337|182971271|SUPERIORITY||LS Mean Difference|0.1||||0.723|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||0.6|-0.4|0.7230
91546175|NCT02638337|182971271|SUPERIORITY||LS Mean Difference|0.4||||0.1104|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||0.9|-0.1|0.1104
91546176|NCT02638337|182971271|SUPERIORITY||LS Mean Difference|0.3||||0.2448|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||0.9|-0.2|0.2448
91546177|NCT02638337|182971272|SUPERIORITY||LS Mean Difference|-4388.3||||0.4263|TWO_SIDED|95.0|-15214.8|6438.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||6438.3|-15214.8|0.4263
91546178|NCT02638337|182971273|SUPERIORITY||LS Mean Difference|-0.049|||<|0.0001|TWO_SIDED|95.0|-0.071|-0.027|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.027|-0.071|<0.0001
91546179|NCT02638337|182971274|SUPERIORITY||LS Mean Difference|-0.14||||0.5159|TWO_SIDED|95.0|-0.58|0.29|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||0.29|-0.58|0.5159
91546180|NCT02638337|182971275|SUPERIORITY||LS Mean Difference|-0.75||||0.0227|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-1.39|0.0227
91546181|NCT02638337|182971276|SUPERIORITY||LS Mean Difference|-0.22||||0.0003|TWO_SIDED|95.0|-0.34|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-0.34|0.0003
91546182|NCT02638337|182971277|SUPERIORITY||LS Mean Difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.1|-4.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-4.3|-8.1|<0.0001
91546183|NCT02638337|182971278|SUPERIORITY||LS Mean Difference|-1.35||||0.0084|TWO_SIDED|95.0|-2.35|-0.35|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.35|-2.35|0.0084
91546184|NCT02638337|182971279|SUPERIORITY||LS Mean Difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.92|-1.19|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-1.19|-2.92|<0.0001
91546185|NCT02638337|182971280|SUPERIORITY||LS Mean Difference|-5.26|||<|0.0001|TWO_SIDED|95.0|-7.64|-2.89|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-2.89|-7.64|<0.0001
91546186|NCT02638337|182971281|SUPERIORITY|||||||0.9575|||||||Welch's t-test|||||||0.9575
91546187|NCT02638337|182971282|SUPERIORITY|||||||0.8772|||||||Welch's t-test|||||||0.8772
91546188|NCT02638337|182971283|SUPERIORITY|||||||0.0007|||||||Wilcoxon rank-sum test|||||||0.0007
91546189|NCT04315181|182971294|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=6.89, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
91546190|NCT04315181|182971295|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=5.51, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
91546191|NCT04315181|182971296|SUPERIORITY|||||||0.138||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=1.61, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.138
91546192|NCT04315181|182971297|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=8.15, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
91546193|NCT04315181|182971298|SUPERIORITY|||||||0.0002||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=4.58, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.0002
91546194|NCT01066026|182971319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|pilot study.|descritive variables|50.0|||<|0.0001|TWO_SIDED|95.0|5.0|95.0|||McNemar||50 was the percentage of hematomas expected for standard needle group.|||95|5|<0.0001
91546195|NCT06647238|182971324|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91765375|NCT00413218|183419684|OTHER||Adjusted Treatment Difference (%)|-15.9|||||TWO_SIDED|95.0|-23.5|-8.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-8.4|-23.5|
91765376|NCT00413218|183419684|OTHER||Adjusted Treatment Difference (%)|-0.7|||||TWO_SIDED|95.0|-8.1|9.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||9.6|-8.1|
91765377|NCT00413218|183419684|OTHER||Adjusted Treatment Difference (%)|-5.2|||||TWO_SIDED|95.0|-14.7|4.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.3|-14.7|
91765378|NCT00413218|183419685|OTHER||Adjusted Treatment Difference (%)|-11.4|||||TWO_SIDED|95.0|-20.4|-2.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-2.5|-20.4|
91765379|NCT00413218|183419685|OTHER||Adjusted Treatment Difference (%)|-8.5|||||TWO_SIDED|95.0|-16.5|-0.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.4|-16.5|
91765380|NCT00413218|183419686|OTHER||Adjusted Treatment Difference (%)|-11.1|||||TWO_SIDED|95.0|-20.3|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-20.3|
91765381|NCT00413218|183419686|OTHER||Adjusted Treatment Difference (%)|-8.1|||||TWO_SIDED|95.0|-16.3|0.1|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||0.1|-16.3|
91546196|NCT00539734|182971341|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.||||<0.05
91546197|NCT02814838|182971352|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.3303|TWO_SIDED|95.0|-0.14|0.42|||Student's t test for unpaired samples|||Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.||0.42|-0.14|0.3303
91546198|NCT02814838|182971353|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|0.0984||||0.517|TWO_SIDED|95.0|-0.2028|0.3995|||Mixed Models Analysis|||at FUP week 26||0.3995|-0.2028|0.517
91546199|NCT02814838|182971353|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|-0.0486||||0.7999|TWO_SIDED|95.0|-0.4294|0.3322|||Mixed Models Analysis|||At FUP week 52||0.3322|-0.4294|0.7999
91765382|NCT00413218|183419687|OTHER||Adjusted Treatment Difference (%)|2.5|||||TWO_SIDED|95.0|-3.8|8.9||||||Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||8.9|-3.8|
91546200|NCT02814838|182971354|SUPERIORITY||adjusted mean difference|12.0411||||0.2224|TWO_SIDED|95.0|-7.3823|31.4644|||Mixed Models Analysis|||at week 13||31.4644|-7.3823|0.2224
91546201|NCT02814838|182971354|SUPERIORITY||adjusted mean difference|8.4803||||0.3931|TWO_SIDED|95.0|-11.0935|28.0541|||Mixed Models Analysis|||At week 26||28.0541|-11.0935|0.3931
91546202|NCT02814838|182971354|SUPERIORITY||adjusted mean difference|-2.9502||||0.7664|TWO_SIDED|95.0|-22.5476|16.6473|||Mixed Models Analysis|||At week 52||16.6473|-22.5476|0.7664
91765383|NCT00413218|183419687|OTHER||Adjusted Treatment Difference (%)|1.4|||||TWO_SIDED|95.0|-7.1|10.0||||||Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||10.0|-7.1|
91546203|NCT02814838|182971355|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.048||||0.2225|TWO_SIDED|95.0|-0.1257|0.0298|||Mixed Models Analysis|||at week 13||0.0298|-0.1257|0.2225
91765384|NCT01618669|183419710|NON_INFERIORITY_OR_EQUIVALENCE|If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.|Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.015|||TWO_SIDED|95.0|-0.06|0.0|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||-0.00|-0.06|
91765385|NCT01618669|183419712|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.|Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.14|0.11|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||0.11|-0.14|
91765386|NCT01618669|183419713|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.|Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.07|0.04||||||||0.04|-0.07|
91765387|NCT01618669|183419714|SUPERIORITY_OR_OTHER||Difference|0.02|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
91546204|NCT02814838|182971355|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.0369||||0.551|TWO_SIDED|95.0|-0.1596|0.0858|||Mixed Models Analysis|||at week 26||0.0858|-0.1596|0.551
91546205|NCT02814838|182971355|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.063||||0.2501|TWO_SIDED|95.0|-0.1712|0.0453|||Mixed Models Analysis|||at week 52||0.0453|-0.1712|0.2501
91546206|NCT02814838|182971356|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.1494||||0.6252|TWO_SIDED|95.0|-0.7514|0.4526|||Mixed Models Analysis|||at FU week 13||0.4526|-0.7514|0.6252
91546207|NCT02814838|182971356|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2804||||0.366|TWO_SIDED|95.0|-0.8904|0.3297|||Mixed Models Analysis|||At FU week 26||0.3297|-0.8904|0.366
91546208|NCT02814838|182971356|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2063||||0.5026|TWO_SIDED|95.0|-0.3992|0.8118|||Mixed Models Analysis|||At FU week 52||0.8118|-0.3992|0.5026
91546209|NCT02814838|182971357|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0242||||0.2527|TWO_SIDED|95.0|-0.0174|0.0658|||Mixed Models Analysis|||at week 13||0.0658|-0.0174|0.2527
91546210|NCT02814838|182971357|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0236||||0.2743|TWO_SIDED|95.0|-0.0188|0.066|||Mixed Models Analysis|||at week 26||0.066|-0.0188|0.2743
91546211|NCT02814838|182971357|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0059||||0.7856|TWO_SIDED|95.0|-0.0485|0.0367|||Mixed Models Analysis|||at week 52||0.0367|-0.0485|0.7856
91546212|NCT02814838|182971358|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0253||||0.9307|TWO_SIDED|95.0|-0.5986|0.548|||Mixed Models Analysis|||at week 13||0.548|-0.5986|0.9307
91546213|NCT02814838|182971358|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.7236||||0.0139|TWO_SIDED|95.0|-1.2989|-0.1483|||Mixed Models Analysis|||At week 26||-0.1483|-1.2989|0.0139
91546214|NCT02814838|182971358|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.5979||||0.0432|TWO_SIDED|95.0|-1.1775|-0.0184|||Mixed Models Analysis|||at week 52||-0.0184|-1.1775|0.0432
91765388|NCT01825187|183419726|SUPERIORITY|||||||0.523|||||||t-test, 1 sided|||||||0.523
91765389|NCT01825187|183419727|SUPERIORITY|||||||0.371|||||||t-test, 1 sided|||Nasa Mental Demand||||0.371
91765390|NCT01825187|183419727|SUPERIORITY|||||||0.122|||||||t-test, 1 sided|||NASA Physical Demand||||0.122
91546215|NCT02814838|182971360|SUPERIORITY|||||||0.1171|||||||Fisher Exact|||at week 13||||0.1171
91546216|NCT02814838|182971360|SUPERIORITY|||||||0.6586|||||||Fisher Exact|||At week 26||||0.6586
91765391|NCT01825187|183419727|SUPERIORITY|||||||0.325|||||||t-test, 1 sided|||NASA Temporal Demand||||0.325
91765392|NCT01825187|183419727|SUPERIORITY|||||||0.0451|||||||t-test, 1 sided|||NASA Peformance||||0.0451
91765393|NCT02888106|183419774|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||The proportions of negative HDV RNA response at week 72 in each of the MXB treatment groups were compared with the control group of PEG-IFNα by using Fisher's exact test and by presenting exact unconditional 95%-confidence intervals (CI) based on scores for the proportion differences.||||0.0022
91765394|NCT02888106|183419774|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
91765395|NCT02888106|183419774|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91765396|NCT02888106|183419774|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
91765397|NCT02888106|183419774|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
91765398|NCT02888106|183419775|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
91765399|NCT02888106|183419775|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
91546217|NCT02814838|182971360|SUPERIORITY|||||||0.5056|||||||Fisher Exact|||At week 52||||0.5056
91546218|NCT02814838|182971361|SUPERIORITY|||||||0.0779|||||||Fisher Exact|||at week 13||||0.0779
91546219|NCT02814838|182971361|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||At week 26||||0.0248
91546220|NCT02814838|182971361|SUPERIORITY|||||||0.4504|||||||Fisher Exact|||At week 52||||0.4504
91546221|NCT02814838|182971362|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.1402||||0.4163|TWO_SIDED|95.0|-0.2015|0.4819|||Mixed Models Analysis|||At week 13||0.4819|-0.2015|0.4163
91546222|NCT02814838|182971362|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.177||||0.3575|TWO_SIDED|95.0|-0.2039|0.558|||Mixed Models Analysis|||At week 26||0.558|-0.2039|0.3575
91546223|NCT02814838|182971362|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.0451||||0.8386|TWO_SIDED|95.0|-0.3948|0.4851|||Mixed Models Analysis|||At week 52||0.4851|-0.3948|0.8386
91546224|NCT02814838|182971363|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.354|||=|0.1114|TWO_SIDED|95.0|-0.09|0.75|||t-test, 2 sided|||At week 13||0.75|-0.09|= 0.1114
91765400|NCT02888106|183419775|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91546225|NCT02814838|182971363|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.502|||=|0.0411|TWO_SIDED|95.0|0.02|0.98|||t-test, 2 sided|||At week 26||0.98|0.02|= 0.0411
91546226|NCT02814838|182971363|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.223|||=|0.4506|TWO_SIDED|95.0|-0.37|0.82|||t-test, 2 sided|||At week 52||0.82|-0.37|= 0.4506
91546227|NCT02814838|182971364|SUPERIORITY||Adjusted mean difference|0.3631||||0.1847|TWO_SIDED|95.0|-0.1817|0.908|||Mixed Models Analysis|||Week 13 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.908|-0.1817|0.1847
91546228|NCT02814838|182971364|SUPERIORITY||Adjusted mean difference|0.6304||||0.031|TWO_SIDED|95.0|0.0609|1.1998|||Mixed Models Analysis|||Week 26 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||1.1998|0.0609|0.031
91546229|NCT02814838|182971364|SUPERIORITY||Adjusted mean difference|0.1639||||0.6299|TWO_SIDED|95.0|-0.5202|0.8479|||Mixed Models Analysis|||Week 52 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.8479|-0.5202|0.6299
91546230|NCT02814838|182971365|SUPERIORITY|||||||0.163|||||||Fisher Exact|||Week 13||||0.163
91546231|NCT02814838|182971365|SUPERIORITY|||||||0.0074|||||||Fisher Exact|||Week 26||||0.0074
91546232|NCT02814838|182971365|SUPERIORITY|||||||0.4437|||||||Fisher Exact|||Week 52||||0.4437
91546233|NCT00709098|182971406|SUPERIORITY_OR_OTHER||Mean group difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.0|-3.1|||t-test, 2 sided|||||-3.1|-7.0|<0.0001
91546234|NCT00774852|182971407|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.85
91546235|NCT00774852|182971408|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.99
91546236|NCT00774852|182971409|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
91546237|NCT00774852|182971409|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.72
91546238|NCT00774852|182971410|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
91546239|NCT00774852|182971415|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
91546240|NCT00774852|182971416|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
91546241|NCT00774852|182971418|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.23
91546242|NCT00774852|182971418|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.61
91546243|NCT00774852|182971418|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
91546244|NCT00774852|182971418|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
91546245|NCT00774852|182971423|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.79
91765401|NCT02888106|183419775|SUPERIORITY|||||||0.0017|||||||Fisher Exact|||Week 24||||0.0017
91765402|NCT02888106|183419775|SUPERIORITY|||||||0.3295|||||||Fisher Exact|||Week 24||||0.3295
91765403|NCT02888106|183419775|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
91765404|NCT02888106|183419775|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Week 48||||0.0001
91546246|NCT00774852|182971423|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.74
91546247|NCT00774852|182971424|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Pneumococcal vaccines||||0.43
91546248|NCT00774852|182971424|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Tetanus Toxoid vaccines||||0.99
91546249|NCT04402294|182971440|OTHER|Parametric inferential statistical test|Group mean difference|0.71||||0.5|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.50
91546250|NCT04402294|182971441|OTHER|Parametric inferential statistical test|Group mean difference|0.03||||0.975|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.975
91546251|NCT04402294|182971442|OTHER|Parametric inferential statistical test|Group mean difference|2.05||||0.097|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.097
91546252|NCT04402294|182971443|OTHER|Parametric Inferential Statistical Test|Group mean difference|0.63||||0.644|TWO_SIDED|||||The threshold for statistical significance was 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.644
91546253|NCT04402294|182971444|OTHER|Parametric inferential statistical test|Group mean difference|0.84||||0.439|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), and stimulation days (1 to 3) as within-subject variables.||||0.439
91546254|NCT04402294|182971445|OTHER|Parametric inferential statistical test|Group mean difference|0.59||||0.563|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||Optimal Neuromodulation Day-1, Optimal Neuromodulation Day-2, Optimal Neuromodulation Day-3, Suboptimal Neuromodulation Day-1, Suboptimal Neuromodulation Day-2, Suboptimal Neuromodulation Day-3||||0.563
91765405|NCT02888106|183419775|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91765406|NCT02888106|183419775|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
91546255|NCT03611153|182971466|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.040
91546256|NCT03611153|182971468|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
91546257|NCT03611153|182971469|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||Right atrial pressure||||0.805
91546258|NCT03611153|182971469|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||pulmonary artery systolic pressure||||0.148
91546259|NCT03611153|182971469|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.090
91546260|NCT03611153|182971470|SUPERIORITY|||||||0.786|||||||t-test, 2 sided|||Right atrial pressure||||0.786
91546261|NCT03611153|182971470|SUPERIORITY|||||||0.796|||||||t-test, 2 sided|||Pulmonary artery systolic pressure||||0.796
91546262|NCT03611153|182971470|SUPERIORITY|||||||0.703|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.703
91546263|NCT03611153|182971471|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
91546264|NCT03611153|182971472|SUPERIORITY|||||||0.669|||||||t-test, 2 sided|||||||0.669
91546265|NCT05338086|182971473|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.51|0.91||Mixed-model for repeated measures (MMRM)|Mixed Models Analysis|MMRM included treatment, with stratification variables as classification factors and baseline BMD as a continuous covariate.||||0.91|-0.51|
91546266|NCT05338086|182971474|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.69|0.74|||ANCOVA|ANCOVA included terms for treatment, with stratification variables as classification factors and baseline BMD included as a continuous covariate.|The estimated mean difference in %CfB lumbar spine BMD results was pooled using Rubin's methods and presented with 95% CI.|||0.74|-0.69|
91546267|NCT05338086|182971477|EQUIVALENCE|Equivalence criteria (analysis set mFAS): 95% CI for ratio of geometric LS mean ratios contained in acceptance limits (80.00%, 125.00%).|Ratio of Geometric means|99.91|||||TWO_SIDED|95.0|91.99|108.52|||ANCOVA|ANCOVA model including log-transformed baseline sCTX as a continuous covariate with treatment and stratification variables as fixed effects.||||108.52|91.99|
91765407|NCT02888106|183419775|SUPERIORITY|||||||0.1086|||||||Fisher Exact|||Week 48||||0.1086
91765408|NCT02888106|183419776|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765409|NCT02888106|183419776|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
91765410|NCT02888106|183419776|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Week 24||||0.0002
91765411|NCT02888106|183419776|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
91765412|NCT02888106|183419776|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 24||||0.0007
91765413|NCT02888106|183419776|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91765414|NCT02888106|183419776|SUPERIORITY|||||||0.4497|||||||Fisher Exact|||Week 48||||0.4497
91765415|NCT02888106|183419776|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
91765416|NCT02888106|183419776|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91546268|NCT05338086|182971478|EQUIVALENCE|Biosimilarity with respect to PD was concluded if the 95% CI for the test (MB09) to reference (EU-Prolia) ratios of the geometric LS means was contained within the \[80.00%, 125.00%\] interval.|Ratio of Geometric means|99.13|||||TWO_SIDED|95.0|96.31|102.02|||ANCOVA|||||102.02|96.31|
91546269|NCT05338086|182971479|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|104.13|||||TWO_SIDED|95.0|98.83|109.71|||ANCOVA|Cmax was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||109.71|98.83|
91546270|NCT05338086|182971480|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|106.06|||||TWO_SIDED|95.0|99.84|112.66|||ANCOVA|AUC0-6 months was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||112.66|99.84|
91546271|NCT03467542|182971499|OTHER||||||||||||||||||The total number evaluated, the percent, and the Clopper-Pearson two-sided 95% confidence limits on the percent.|||
91546272|NCT05387447|182971502|OTHER|||||||0.05|||||||Z score|||||||.05
91546273|NCT05387447|182971503|OTHER|||||||0.05|||||||Z score|||||||.05
91546274|NCT05387447|182971505|OTHER|||||||0.05|||||||Z score|||||||.05
91546275|NCT05387447|182971506|OTHER|||||||0.05|||||||Z score|||||||.05
91546276|NCT03655132|182971524|OTHER|Regression of baseline score on intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.12||||0.62|TWO_SIDED||||||Regression, Linear|||||||.62
91546277|NCT03655132|182971524|OTHER|Regression of baseline score on perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.19||||0.45|TWO_SIDED||||||Regression, Linear|||||||.45
91546278|NCT03655132|182971524|OTHER|Regression of baseline score on perceived usefulness of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.02||||0.93|TWO_SIDED||||||Regression, Linear|||||||.93
91546279|NCT03655132|182971524|OTHER|Regression of post-intervention score of intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.51||||0.04|TWO_SIDED||||||Regression, Linear|||||||.04
91546280|NCT03655132|182971524|OTHER|Regression of post-intervention score of perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.54||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
91546281|NCT03655132|182971524|OTHER|Regression of post-intervention score of perceived usefulness of VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.58||||0.01|TWO_SIDED||||||Regression, Linear|||||||.01
91546282|NCT03655132|182971525|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for waitlist control group participants only (n=22).|Median Difference (Net)|-5.0||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.54
91546283|NCT03655132|182971525|OTHER||Median Difference (Net)|-1.5||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for VACT-CP group.||||.59
91546284|NCT03655132|182971526|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|2.0||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
91546285|NCT03655132|182971526|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
91546286|NCT03655132|182971527|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.13
91546287|NCT03655132|182971527|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|3.0||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.07
91546288|NCT03655132|182971528|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.0||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.64
91546289|NCT03655132|182971528|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.3||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.30
91546290|NCT03655132|182971529|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.75
91546291|NCT03655132|182971529|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.5||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.60
91765417|NCT02888106|183419776|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
91765418|NCT02888106|183419776|SUPERIORITY|||||||0.0743|||||||Fisher Exact|||Week 72||||0.0743
91765419|NCT02888106|183419776|SUPERIORITY|||||||0.3449|||||||t-test, 1 sided|||Week 72||||0.3449
91765420|NCT02888106|183419776|SUPERIORITY|||||||0.6036|||||||Fisher Exact|||Week 72||||0.6036
91765421|NCT02888106|183419776|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
91546292|NCT05919082|182971540|OTHER||Odds Ratio (OR)|1.4||||0.0438|TWO_SIDED|95.0|1.01|1.99|||Regression, Logistic||The odds ratio and p-value are obtained by logistic regression model, adjusted for baseline PGA. Wald CI was presented.|||1.99|1.01|0.0438
91546293|NCT05919082|182971541|OTHER||Odds Ratio (OR)|1.5||||0.0108|TWO_SIDED|95.0|1.1|2.12|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.12|1.10|0.0108
91546294|NCT05919082|182971542|OTHER||Odds Ratio (OR)|1.5||||0.0199|TWO_SIDED|95.0|1.07|2.19|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.19|1.07|0.0199
91546295|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MontgomeryÅsberg Depression Rating Scale (MADRS) ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0105|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0105
91546296|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0134|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.03|-0.14|0.0134
91546297|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3495|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3495
91546298|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7008|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex right||0.04|-0.07|0.7008
91546299|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6635|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.05|-0.08|0.6635
91546300|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8792|TWO_SIDED|90.0|-0.09|0.07|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.07|-0.09|0.8792
91546301|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0419|TWO_SIDED|90.0|-0.15|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.02|-0.15|0.0419
91546302|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1658|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.01|-0.12|0.1658
91546303|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6673|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % change/ Amygdala Left||0.05|-0.08|0.6673
91546304|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0778|TWO_SIDED|90.0|-0.14|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % Change/ Amygdala Right||-0.01|-0.14|0.0778
91546305|NCT03854578|182971544|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3258|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3258
91546306|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5954|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.04|-0.07|0.5954
91546307|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5911|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.04|-0.08|0.5911
91765422|NCT02888106|183419776|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
91765423|NCT02888106|183419777|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765424|NCT02888106|183419777|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
91546308|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8283|TWO_SIDED|90.0|-0.11|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.08|-0.11|0.8283
91546309|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1797|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.01|-0.12|0.1797
91546310|NCT03854578|182971544|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5772|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.04|-0.08|0.5772
91546311|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0147|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0147
91546312|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.048|TWO_SIDED|90.0|-0.13|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.01|-0.13|0.0480
91546313|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0294|TWO_SIDED|90.0|-0.12|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||-0.02|-0.12|0.0294
91546314|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0359|TWO_SIDED|90.0|-0.13|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||-0.02|-0.13|0.0359
91546315|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.19|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||-0.06|-0.19|0.0022
91546316|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|90.0|-0.15|0.0|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.00|-0.15|0.1040
91765425|NCT02888106|183419777|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
91765426|NCT02888106|183419777|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
91765427|NCT02888106|183419777|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
91765428|NCT02888106|183419777|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
91765429|NCT02888106|183419777|SUPERIORITY|||||||0.1686|||||||Fisher Exact|||Week 48||||0.1686
91765430|NCT02888106|183419777|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91765431|NCT02888106|183419777|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
91765432|NCT02888106|183419777|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91765433|NCT02888106|183419777|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 72||||0.0063
91765434|NCT02888106|183419777|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
91765435|NCT02888106|183419777|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
91765436|NCT02888106|183419777|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
91765437|NCT02888106|183419777|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
91765438|NCT02888106|183419778|SUPERIORITY|||||||0.0801|||||||Fisher Exact|||Week 24||||0.0801
91765439|NCT02888106|183419778|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765440|NCT02888106|183419778|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765441|NCT02888106|183419778|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765442|NCT02888106|183419778|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765443|NCT02888106|183419778|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 48||||0.0063
91765444|NCT02888106|183419778|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 48||||0.2241
91765445|NCT02888106|183419778|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91765446|NCT02888106|183419778|SUPERIORITY|||||||0.0169|||||||Regression, Cox|||Week 72||||0.0169
91765447|NCT02888106|183419778|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
91765448|NCT02888106|183419778|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
91765449|NCT02888106|183419779|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 48||||0.4828
91765450|NCT02888106|183419779|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91546317|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.18|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.06|-0.18|0.0022
91546318|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0331|TWO_SIDED|90.0|-0.14|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||-0.02|-0.14|0.0331
91546319|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.2149|TWO_SIDED|90.0|-0.11|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||0.02|-0.11|0.2149
91546320|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6896|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||0.05|-0.08|0.6896
91546321|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4769|TWO_SIDED|90.0|-0.06|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.06|0.4769
91546322|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.768|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.05|-0.07|0.7680
91546323|NCT03854578|182971545|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7997|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.06|-0.08|0.7997
91546324|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.8334|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.06|-0.08|0.8334
91546325|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7402|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.05|-0.07|0.7402
91546326|NCT03854578|182971545|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.812|TWO_SIDED|90.0|-0.06|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.08|-0.06|0.8120
91546327|NCT03732820|182971605|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.81||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.81|0.54|<0.0001
91546328|NCT03732820|182971606|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0544|TWO_SIDED|95.0|0.67|1.0||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.00|0.67|0.0544
91765451|NCT02888106|183419779|SUPERIORITY|||||||0.2292|||||||Fisher Exact|||Week 72||||0.2292
91765452|NCT02888106|183419779|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
91765453|NCT02888106|183419780|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
91765454|NCT02888106|183419780|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||Week 24||||1.0000
91765455|NCT02888106|183419780|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
91765456|NCT02888106|183419780|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
91765457|NCT02888106|183419780|SUPERIORITY|||||||0.0253|||||||Fisher Exact|||Week 24||||0.0253
91765458|NCT02888106|183419780|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
91765459|NCT02888106|183419780|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
91546329|NCT03732820|182971607|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0025|TWO_SIDED|95.0|0.64|0.9|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.90|0.64|0.0025
91546330|NCT03732820|182971608|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7456|TWO_SIDED|95.0|0.75|1.5|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.50|0.75|0.7456
91546331|NCT03732820|182971609|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.3099|TWO_SIDED|95.0|0.82|1.79|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.79|0.82|0.3099
91546332|NCT03732820|182971610|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3212|TWO_SIDED|95.0|0.55|1.22|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.22|0.55|0.3212
91546333|NCT03732820|182971611|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.59|0.99|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.99|0.59|0.0534
91546334|NCT00999167|182971683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354|TWO_SIDED|95.0|||||Poisson regression adjusting for country|||||||0.0354
91546335|NCT00999167|182971684|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||Cochran-Mantel-Haenszel|||||||0.0214
91546336|NCT00999167|182971685|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.047||95.0|||||Regression, Cox|||||||0.047
91546337|NCT00999167|182971686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0713|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and Day 56.||||0.0713
91546338|NCT00999167|182971686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and the Final Visit.||||0.2520
91546339|NCT02641912|182971687|SUPERIORITY_OR_OTHER||Least sqaure (LS) mean difference|0.63||||0.0084|TWO_SIDED|95.0|0.17|1.1|||ANOVA|From ANOVA model with factors for treatment and confirmed Sjögren's syndrome status stratification using Observed Margins option.|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|||1.10|0.17|0.0084
91546340|NCT01340066|182971768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.92|ONE_SIDED|80.0|||||Chi-squared|||||||.92
91546341|NCT03338816|182971775|SUPERIORITY||Rate ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.41||P=6.040E-09|Negative binomial regression model|||Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.||0.41|0.16|<0.0001
91546342|NCT04238247|182971787|SUPERIORITY||Odds Ratio (OR)|1.876119||||0.006|TWO_SIDED|95.0|1.193531|2.949084||The threshold for statistical significance was p = 0.05.|Regression, Logistic|We conducted logistic regression adjusted for randomization strata (recommended CRS and reason for eligibility).||We hypothesized the intervention group would have greater child passenger safety guideline adherence at 6 months compared with enhanced usual care group. In planning the trial, we assumed 75% of TCBD caregivers would be re-randomized. Baseline randomization was stratified by recommended CRS (rear-facing seat, forward-facing seat, booster seat) and reason for eligibility (not using the recommended CRS at baseline or planning a premature transition in the next 6 months).||2.949084|1.193531|0.006
91546343|NCT04238247|182971788|SUPERIORITY||Odds Ratio (OR)|0.8686678||||0.671|TWO_SIDED|95.0|0.4535589|1.663695||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||This analysis is limited to the Phase 2 participants who were re-randomized at 6 months to test the hypothesis that the enhanced intervention (with booster MI session) would have greater guideline adherent child passenger safety behaviors at 12 month follow-up than the group that continued in the basic intervention (mHealth components).||1.663695|0.4535589|0.671
91546344|NCT04238247|182971788|SUPERIORITY||Odds Ratio (OR)|6.859599|||<|0.001|TWO_SIDED|95.0|3.173121|14.82896|||Regression, Logistic|||||14.82896|3.173121|<0.001
91765460|NCT02888106|183419780|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
91546345|NCT04238247|182971791|SUPERIORITY||Odds Ratio (OR)|1.74029||||0.032|TWO_SIDED|95.0|1.049169|2.886676||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.886676|1.049169|0.032
91546346|NCT04238247|182971792|SUPERIORITY||Odds Ratio (OR)|1.112874||||0.752|TWO_SIDED|95.0|0.5735782|2.159233||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.159233|0.5735782|0.752
91546347|NCT04238247|182971792|SUPERIORITY||Odds Ratio (OR)|7.959981|||<|0.001|TWO_SIDED|95.0|3.321933|19.07362|||Regression, Logistic|||||19.07362|3.321933|<0.001
91546348|NCT04950127|182971799|SUPERIORITY||Mean Difference (Net)|-0.72||||0.001|TWO_SIDED|95.0|-1.15|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly Itch score (MIS), Visit\*Baseline MIS interaction, Baseline Concomitant Itch Medication.||-0.28|-1.15|0.001
91546349|NCT04950127|182971800|SUPERIORITY||Mean Difference (Net)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.07|-0.34||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Week, Week\*Treatment Group interaction, Baseline Weekly Itch score (WIS), Visit\*Baseline WIS interaction, Baseline Concomitant Itch Medication.||-0.34|-1.07|<0.001
91765461|NCT02888106|183419780|SUPERIORITY|||||||0.0656|||||||Fisher Exact|||Week 48||||0.0656
91765462|NCT02888106|183419780|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||Week 48||||0.0005
91765463|NCT02888106|183419780|SUPERIORITY|||||||0.1431|||||||Fisher Exact|||Week 72||||0.1431
91546350|NCT04950127|182971801|SUPERIORITY||Mean Difference (Net)|-0.53||||0.024|TWO_SIDED|95.0|-0.98|-0.07||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly sleep score (MSS), Visit\*Baseline MSS interaction, Baseline Concomitant Itch Medication.||-0.07|-0.98|0.024
91546351|NCT04950127|182971802|SUPERIORITY||Percentage difference|4.0||||0.539||95.0|-9.0|17.0||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and less than \[\<\]7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains Bile Acid Binding Resin \[BABR\], Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||17.0|-9.0|0.539
91546352|NCT04950127|182971803|SUPERIORITY||Percentage Difference|13.0||||0.043|TWO_SIDED|95.0|0.0|27.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||27.0|0.0|0.043
91546353|NCT04950127|182971804|SUPERIORITY||Percentage Difference|12.0||||0.058|TWO_SIDED|95.0|0.0|24.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||24.0|-0.0|0.058
91546354|NCT04950127|182971805|SUPERIORITY|Cognitive|Mean Difference (Net)|0.76||||0.176|TWO_SIDED|95.0|-0.34|1.86||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.86|-0.34|0.176
91765464|NCT02888106|183419780|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
91546355|NCT04950127|182971805|SUPERIORITY|Emotional|Mean Difference (Net)|0.27||||0.403|TWO_SIDED|95.0|-0.36|0.89||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.89|-0.36|0.403
91546356|NCT04950127|182971805|SUPERIORITY|Fatigue|Mean Difference (Net)|1.59||||0.132|TWO_SIDED|95.0|-0.48|3.67||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||3.67|-0.48|0.132
91546357|NCT04950127|182971805|SUPERIORITY|Itch|Mean Difference (Net)|-0.58||||0.132|TWO_SIDED|95.0|-1.34|0.18||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.18|-1.34|0.132
91546358|NCT04950127|182971805|SUPERIORITY|Social|Mean Difference (Net)|-0.15||||0.836|TWO_SIDED|95.0|-1.57|1.27||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.27|-1.57|0.836
91546359|NCT04950127|182971805|SUPERIORITY|Symptoms|Mean Difference (Net)|0.45||||0.318|TWO_SIDED|95.0|-0.44|1.34||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.34|-0.44|0.318
91765465|NCT02888106|183419780|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
91765466|NCT02888106|183419780|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
91765467|NCT02888106|183419780|SUPERIORITY|||||||0.7104|||||||Fisher Exact|||Week 72||||0.7104
91765468|NCT01425801|183419802|SUPERIORITY_OR_OTHER||Least Squares Mean DIfference|0.405|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.353|0.458|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.458|0.353|<0.0001
91765469|NCT01425801|183419802|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.371|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.318|0.424|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.424|0.318|<0.0001
91546360|NCT04950127|182971806|SUPERIORITY||Mean Difference (Net)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.55|-0.2||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PGI-S score, Visit\*Baseline PGI-S score interaction, Baseline Concomitant Itch Medication.||-0.20|-0.55|<0.001
91546361|NCT04950127|182971807|SUPERIORITY||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.76|-0.21||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Concomitant Itch Medication.||-0.21|-0.76|<0.001
91546362|NCT00522951|182971851|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.58||||||95.0|-0.87|-0.29|||||Averaged blinded reader (primary analysis)|H01: μG1 - μPr ≤ -1||-0.29|-0.87|
91546363|NCT00522951|182971851|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.06||||||95.0|-0.23|0.36|||||Averaged blinded reader (primary analysis)|H02: μG2 - μPr ≤ -1||0.36|-0.23|
91546364|NCT00522951|182971851|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.3||||||95.0|-0.5|-0.1|||||Investigator (secondary analysis)|H01: μG1 - μPr ≤ -1||-0.1|-0.5|
91546365|NCT00522951|182971851|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.21||||||95.0|0.02|0.41|||||Investigator (secondary analysis)|H02: μG2 - μPr ≤ -1||0.41|0.02|
91546366|NCT02713126|182971867|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.770
91546367|NCT02713126|182971868|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
91546368|NCT02713126|182971869|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
91546369|NCT02713126|182971870|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||0.708
91546370|NCT02713126|182971871|SUPERIORITY|||||||0.496|||||||t-test, 2 sided|||||||0.496
91546371|NCT02140645|182971872|SUPERIORITY_OR_OTHER||C-statistics|0.624|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546372|NCT02140645|182971873|SUPERIORITY_OR_OTHER||C-statistcs|0.597|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546373|NCT02140645|182971874|SUPERIORITY_OR_OTHER||R-squared|0.0858|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546374|NCT02140645|182971875|SUPERIORITY_OR_OTHER||C-statistics|0.623|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546375|NCT02140645|182971876|SUPERIORITY_OR_OTHER||R-squared|0.1753|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546376|NCT02140645|182971877|SUPERIORITY_OR_OTHER||C-statistics|0.699|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546377|NCT02140645|182971878|SUPERIORITY_OR_OTHER||C-statistics|0.683|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546378|NCT02140645|182971879|SUPERIORITY_OR_OTHER||C-statistics|0.757|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546379|NCT02140645|182971880|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546380|NCT02140645|182971881|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546381|NCT02140645|182971882|SUPERIORITY_OR_OTHER||C-statistics|0.733|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546382|NCT02140645|182971883|SUPERIORITY_OR_OTHER||C-statistics|0.827|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546383|NCT02140645|182971884|SUPERIORITY_OR_OTHER||C-statistics|0.801|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546384|NCT02140645|182971885|SUPERIORITY_OR_OTHER||C-statistics|0.836|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
91546385|NCT01101451|182971886|SUPERIORITY||Hazard Ratio (HR)|0.6976||||0.0927|TWO_SIDED|95.0|0.408|1.192||the pre\_specified nominal significance level was 0.0451 (one sided).|Log Rank||The RFS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.192|0.408|0.0927
91546386|NCT01101451|182971887|SUPERIORITY||Hazard Ratio (HR)|0.586|||||TWO_SIDED|95.0|0.286|1.199|||||The OS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.199|0.286|
91546387|NCT00390299|182971910|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
91546388|NCT00390299|182971910|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
91546389|NCT00390299|182971914|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.28|TWO_SIDED|95.0|0.67|4.11|||Log Rank|||||4.11|0.67|0.28
91546390|NCT02794480|182971928|SUPERIORITY||||||<|0.001||||||ELLIPTA versus GSK MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||<0.001
91546391|NCT02794480|182971928|SUPERIORITY|||||||0.007||||||ELLIPTA versus AZ MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||0.007
91546392|NCT02794480|182971933|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.42||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus GSK MDI||||2.42|<0.001
91546393|NCT02794480|182971933|SUPERIORITY||Odds Ratio (OR)|4.16||||0.011|TWO_SIDED|95.0|1.59||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus AZ MDI||||1.59|0.011
91546394|NCT00976937|182972050|SUPERIORITY_OR_OTHER||Response rate difference|4.6|STANDARD_ERROR_OF_MEAN|3.28||0.1696|TWO_SIDED|95.0|-1.84|11.0||Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata of screening HbA1c (\<8.0 or \>=8.0%) and randomization strata of screening BMI (\<35 or \>=35 kg/m\^2) was used.|Cochran-Mantel-Haenszel|||To demonstrate the superiority of lixisenatide over sitagliptin, 150 patients in each arm would provide a power of 90% with a 2-sided test at the 5% significance level, assuming the percentage of patients defined as responders on HbA1c (\<7%) and weight (at least 5% loss) is 25% with lixisenatide and 10% with sitagliptin.||11.00|-1.84|0.1696
91546395|NCT04994509|182972098|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||Confidence Interval (CI) for rate ratio vs bHIV is from a likelihood-based method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.042|0.000|<0.0001
91546396|NCT04994509|182972098|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||CI for rate ratio vs bHIV is based on a likelihood-based method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.042|0.000|<0.0001
91546397|NCT04994509|182972098|SUPERIORITY||Rate Ratio|0.839||||0.20697|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 03: F/TAF/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly lower than bHIV.||1.279|0.550|0.20697
91546398|NCT04994509|182972098|SUPERIORITY||Rate Ratio|0.839||||0.58674|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 04: F/TAF/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly and at least 20% lower than bHIV.||1.279|0.550|0.58674
91546399|NCT04994509|182972099|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.101||p-value for rate ratio vs F/TDF is from an exact conditional Poisson model.|Poisson model||CI is from an exact conditional Poisson model.|||0.101|0.000|< 0.0001
91546400|NCT04994509|182972099|SUPERIORITY||Rate Ratio|1.198||||0.7282|TWO_SIDED|95.0|0.669|2.143||p-value for rate ratio vs F/TDF is from a Poisson model.|Poisson model||CI is from a Poisson model.|||2.143|0.669|0.72820
91546401|NCT04994509|182972099|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the LEN group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|-1.685|||<|0.0001|TWO_SIDED|95.0|-2.737|-0.939||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||-0.939|-2.737|<0.0001
91546402|NCT04994509|182972099|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the F/TAF group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|0.333||||0.209|TWO_SIDED|95.0|-0.869|1.367||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||1.367|-0.869|0.20900
91546403|NCT04994509|182972101|SUPERIORITY||Exact Odds Ratio|9.0||||0.0006|TWO_SIDED|95.0|2.06|83.36||p-value is from exact conditional logistic regression model.|ExactConditionalLogisticRegressionModel||Exact odds ratio and and CI are from exact conditional logistic regression model.|||83.36|2.06|0.0006
91546404|NCT05161715|182972142|OTHER|||||||0.425||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.425
91546405|NCT05161715|182972143|OTHER|||||||0.0002||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0002
91546406|NCT05161715|182972144|OTHER|||||||0.0424||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0424
91546407|NCT05161715|182972145|OTHER|||||||0.001||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.001
91546408|NCT05161715|182972150|OTHER|||||||0.556||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.556
91546409|NCT04690673|182972151|EQUIVALENCE|Based on previous reports on the pharmacokinetics of oral paracetamol, the standard deviation of the within-subject difference in the Cmax for paracetamol was estimated to be 35% of the mean Cmax. Using this standard deviation, 10 participants were estimated to be sufficient, with a power of at least 80% (at 5% significance level). We recruited 12 volunteers to account for potential protocol violations or dropouts.|Geometric mean ratio|1.03||||0.05|TWO_SIDED|90.0|0.94|1.13||Not adjusted for multiple comparisons as the analysis was exploratory|t-test, 2 sided||Adhering|Highest paracetamol concentrations (Cmax) measured from capillary with the electrochemical method compared with measurements with mass-spectrometry.||1.13|0.94|0.05
91546410|NCT03743636|182972156|SUPERIORITY||Mean Difference (Final Values)|17.57||||0.0775|ONE_SIDED|90.0|1.77||||Mixed Models Analysis||||||1.77|0.0775
91546411|NCT03743636|182972157|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.3762|ONE_SIDED|90.0|-11.24||||Mixed Models Analysis||||||-11.24|0.3762
91546412|NCT03743636|182972158|SUPERIORITY||Mean Difference (Final Values)|22.42||||0.0294|ONE_SIDED|90.0|7.31||||Mixed Models Analysis||||||7.31|0.0294
91546413|NCT03743636|182972159|SUPERIORITY||Mean Difference (Final Values)|20.63||||0.0336|ONE_SIDED|90.0|6.26||||Mixed Models Analysis||||||6.26|0.0336
91546414|NCT03743636|182972160|SUPERIORITY||Mean Difference (Final Values)|-1.78||||0.562|ONE_SIDED|90.0|-16.51||||Mixed Models Analysis||||||-16.51|0.5620
91546415|NCT03743636|182972161|SUPERIORITY||Mean Difference (Final Values)|-13.93||||0.8797|ONE_SIDED|90.0|-29.15||||Mixed Models Analysis||||||-29.15|0.8797
91546416|NCT03743636|182972162|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24||||ANCOVA||||||0.24|0.0752
91546417|NCT03743636|182972163|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA||||||-15.19|0.8703
91546418|NCT03743636|182972164|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA||||||-2078|0.1402
91546419|NCT03743636|182972165|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.1249|ONE_SIDED|90.0|-0.21||||ANCOVA||||||-0.21|0.1249
91546420|NCT03743636|182972166|SUPERIORITY||Mean Difference (Final Values)|-5.05||||0.8039|ONE_SIDED|90.0|-12.62||||ANCOVA||||||-12.62|0.8039
91546421|NCT03743636|182972167|SUPERIORITY||Mean Difference (Final Values)|-842.0||||0.5352|ONE_SIDED|90.0|-13125.0||||ANCOVA||||||-13125|0.5352
91546422|NCT03743636|182972168|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.5777|ONE_SIDED|90.0|-2.46||||ANCOVA||||||-2.46|0.5777
91546423|NCT03743636|182972169|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.3662|ONE_SIDED|90.0|-5.69||||ANCOVA||||||-5.69|0.3662
91546424|NCT03743636|182972170|SUPERIORITY||Mean Difference (Final Values)|-11837.0||||0.8866|ONE_SIDED|90.0|-24396.0||||ANCOVA||||||-24396|0.8866
91546425|NCT03743636|182972171|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|25.25||||0.0153|ONE_SIDED|90.0|10.43|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|Mixed Models Analysis|||Mixed models for repeated measures were used to compare 3-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||10.43|0.0153
91546426|NCT03743636|182972172|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|14.05||||0.1195|ONE_SIDED|90.0|-1.25||||Mixed Models Analysis|||Mixed models for repeated measures were used to compare 6-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||-1.25|0.1195
91546427|NCT03743636|182972173|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||0.24|0.0752
91546428|NCT03743636|182972174|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-15.19|0.8703
91546429|NCT03743636|182972175|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-2078|0.1402
91546430|NCT03743636|182972176|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA||||||-81.20|0.8401
91546431|NCT03743636|182972177|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
91546432|NCT03743636|182972178|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA||||||-4.47|0.2378
91546433|NCT03743636|182972179|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.1589|ONE_SIDED|90.0|-1.86||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-1.86|0.1589
91546434|NCT03743636|182972179|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
91546435|NCT03743636|182972180|SUPERIORITY||Mean Difference (Final Values)|10.25||||0.3724|ONE_SIDED|90.0|-31.79||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-31.79|0.3724
91546436|NCT03743636|182972180|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-81.20|0.8401
91546437|NCT03743636|182972181|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.5558|ONE_SIDED|90.0|-9.52||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-9.52|0.5558
91546438|NCT03743636|182972181|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-4.47|0.2378
91546439|NCT03743636|182972182|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA||||||-8.97|0.7112
91546440|NCT03743636|182972183|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA||||||-13.31|0.9449
91546441|NCT03743636|182972184|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.5409|ONE_SIDED|90.0|-6.57||||ANCOVA||||||-6.57|0.5409
91546442|NCT03743636|182972185|SUPERIORITY||Mean Difference (Final Values)|-3.35||||0.7814|ONE_SIDED|90.0|-8.89||||ANCOVA||||||-8.89|0.7814
91546443|NCT03743636|182972186|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.5884|ONE_SIDED|90.0|-7.07||||ANCOVA||||||-7.07|0.5884
91546444|NCT03743636|182972187|SUPERIORITY||Mean Difference (Final Values)|4.05||||0.1787|ONE_SIDED|90.0|-1.6||||ANCOVA||||||-1.60|0.1787
91546445|NCT03743636|182972188|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-8.97|0.7112
91546446|NCT03743636|182972189|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-13.31|0.9449
91546447|NCT05485922|182972190|SUPERIORITY|Number of flow-stop episodes will be analysed, in a generalized linier mixed model, with subject included as a random component. Evidence of superior effect will be concluded, if the lower 95% confidence limit of the risk ratio between comparator and investigational device, is more than 1.|Risk Ratio (RR)|0.16|||<|0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||||0.44|0.05|<0.05
91546448|NCT05485922|182972191|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.05|TWO_SIDED|95.0|14.69|53.91||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||53.91|14.69|0.05
91546449|NCT05485922|182972192|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.16||||0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.44|0.05|0.05
91546450|NCT05485922|182972193|SUPERIORITY||Mean Difference (Final Values)|-95.69||||0.05|TWO_SIDED|95.0|-137.69|-53.7|||Mixed Models Analysis|||The intra-catheter pressure at flow stop was analysed in a general linear mixed model with subject included as a random component.||-53.70|-137.69|0.05
91546451|NCT05485922|182972194|OTHER||Mean Difference (Final Values)|1.21||||0.05|TWO_SIDED|95.0|-11.1|13.51|||Mixed Models Analysis|||||13.51|-11.10|0.05
91546452|NCT05485922|182972195|SUPERIORITY||Odds Ratio (OR)|0.26||||0.05|TWO_SIDED|95.0|0.07|0.96|||Mixed Models Analysis|||Analyzed using a generalized linear mixed model, modelling the probability of a positive outcome. Evidence of effect in favour of the MHZC was concluded if the upper 95% confidence limit (CL) of the odds ratio, O.R. was less than 1.||0.96|0.07|0.05
91546453|NCT04850807|182972220|SUPERIORITY||average marginal effect|-0.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-6.9|6.0|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|6.0|-6.9|<0.05
91546454|NCT04850807|182972221|SUPERIORITY||Average Marginal Effect|0.1|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|95.0|-0.06|0.26|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.26|-0.06|<0.05
91546455|NCT04850807|182972222|SUPERIORITY||average marginal effect|4.0|STANDARD_ERROR_OF_MEAN|3.2|<|0.05|TWO_SIDED|95.0|-2.3|10.2|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|10.2|-2.3|<0.05
91546456|NCT04850807|182972223|SUPERIORITY||average marginal effect|-1.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-8.5|5.6|||Differences-in-Differences regression||||"Results are adjusted for baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~The model includes a random intercept for nursing home."|5.6|-8.5|<0.05
91546457|NCT04850807|182972224|SUPERIORITY||average marginal effect|-4.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-9.8|0.1|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|0.1|-9.8|<0.05
91546458|NCT04850807|182972226|SUPERIORITY||average marginal effect|-0.31|||<|0.05|TWO_SIDED|95.0|-1.03|0.41|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI/PHQ-9 model), baseline CMAI (exclusive to ARBS/PHQ-9 model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.41|-1.03|<0.05
91546459|NCT05141903|182972227|SUPERIORITY||||||<|0.0001||||||(Dose group \* Time)|Mixed Models Analysis|Dfn, Dfd = 11, 369 F Value = 24.31||Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
91546460|NCT05141903|182972227|SUPERIORITY||||||<|0.0001||||||Dose group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 370 F value = 14.87||Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
91546461|NCT05141903|182972227|SUPERIORITY||||||<|0.0001||||||Dose Group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 351 F value = 8.606||Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over time||||<0.0001
91546462|NCT04549168|182972261|SUPERIORITY||LS geometric mean ratio|0.795||||0.0585|TWO_SIDED|95.0|0.627|1.008||Data was analyzed using mixed effect model repeated measurement analysis (MMRM), and the missing values were imputed using multiple imputation and assumed to be missing not at random (MNAR).|MMRM|||||1.008|0.627|0.0585
91546463|NCT04549168|182972262|SUPERIORITY||LSM difference|7.1|||<|0.0001|TWO_SIDED|95.0|4.39|9.81||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.81|4.39|<0.0001
91546464|NCT04549168|182972263|SUPERIORITY||LSM difference|-17.84||||0.0002|TWO_SIDED|95.0|-27.16|-8.51||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-8.51|-27.16|0.0002
91546465|NCT04549168|182972264|SUPERIORITY||LS geometric mean ratio|0.776||||0.0063|TWO_SIDED|95.0|0.647|0.93||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||0.930|0.647|0.0063
91546466|NCT04549168|182972265|SUPERIORITY||LSM difference|4.49||||0.0242|TWO_SIDED|95.0|0.59|8.39||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||8.39|0.59|0.0242
91546467|NCT04549168|182972266|SUPERIORITY||LSM difference|-10.36||||0.1625|TWO_SIDED|95.0|-24.95|4.22||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||4.22|-24.95|0.1625
91546468|NCT04549168|182972267|SUPERIORITY||LS geometric mean ratio|0.815||||0.0515|TWO_SIDED|95.0|0.663|1.001||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||1.001|0.663|0.0515
91546469|NCT04549168|182972268|SUPERIORITY||LSM difference|7.74|||<|0.0001|TWO_SIDED|95.0|5.61|9.86||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.86|5.61|<0.0001
91546470|NCT04549168|182972269|SUPERIORITY||LSM difference|-21.25|||<|0.0001|TWO_SIDED|95.0|-28.15|-14.35||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-14.35|-28.15|<0.0001
91765470|NCT01425801|183419802|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.322|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.269|0.375|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.375|0.269|<0.0001
91546471|NCT04549168|182972271|SUPERIORITY||LSM difference|-2.85|STANDARD_ERROR_OF_MEAN|0.811||0.0006|TWO_SIDED|95.0|-4.45|-1.25||Based on Analysis of Covariance (ANCOVA) model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-1.25|-4.45|0.0006
91546472|NCT04549168|182972272|SUPERIORITY||LSM difference|-1.74|STANDARD_ERROR_OF_MEAN|0.488||0.0005|TWO_SIDED|95.0|-2.7|-0.78||Based on ANCOVA model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-0.78|-2.70|0.0005
91546473|NCT04549168|182972274|SUPERIORITY||LSM difference|0.34||||0.0312|TWO_SIDED|95.0|0.03|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of treatment period|||0.65|0.03|0.0312
91546474|NCT04549168|182972274|SUPERIORITY||LSM difference|0.32||||0.146|TWO_SIDED|95.0|-0.11|0.76||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of treatment period|||0.76|-0.11|0.1460
91546475|NCT04549168|182972274|SUPERIORITY||LSM difference|0.29||||0.1613|TWO_SIDED|95.0|-0.12|0.7||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of follow-up period|||0.70|-0.12|0.1613
91546476|NCT04549168|182972274|SUPERIORITY||LSM difference|0.23||||0.2852|TWO_SIDED|95.0|-0.19|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of follow-up period|||0.65|-0.19|0.2852
91546477|NCT02549339|182972308|SUPERIORITY||Ratio of clearance rates|7.57||||0.001|TWO_SIDED|95.0|2.26|25.31|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||25.31|2.26|0.001
91546478|NCT02549339|182972309|SUPERIORITY||Ratio of clearance rates|5.9|||<|0.001|TWO_SIDED|95.0|3.3|10.54|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.54|3.30|<0.001
91546479|NCT02549339|182972310|SUPERIORITY||Ratio of clearance rates|5.75|||<|0.001|TWO_SIDED|95.0|3.24|10.2|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.20|3.24|<0.001
91546480|NCT02549339|182972311|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.35||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.35|0.25|<0.001
91546481|NCT01095796|182972472|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.6|||||TWO_SIDED|95.2|-1.6|8.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.||8.8|-1.6|
91546482|NCT04349072|182972480|SUPERIORITY||Proportion Difference|58.93|||<|0.0001|TWO_SIDED|95.0|43.989|73.868|||Cochran-Mantel-Haenszel|||||73.868|43.989|<0.0001
91546483|NCT04349072|182972481|SUPERIORITY||Proportion Difference|41.07|||<|0.0001|TWO_SIDED|95.0|24.481|57.662|||Cochran-Mantel-Haenszel|||||57.662|24.481|<0.0001
91546484|NCT04349072|182972482|SUPERIORITY||Leat Square Mean of Treatment Difference|9.45|||<|0.0001|TWO_SIDED|95.0|4.868|14.041|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||14.041|4.868|<0.0001
91546485|NCT04349072|182972483|SUPERIORITY||Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.266|0.421|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.421|0.266|<0.0001
91546486|NCT04349072|182972484|SUPERIORITY||Mean Ratio|0.53|||<|0.0001|TWO_SIDED|95.0|0.406|0.7|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.700|0.406|<0.0001
91546487|NCT04349072|182972485|SUPERIORITY||Leat Square Mean of Treatment Difference|-37.2|||<|0.0001|TWO_SIDED|95.0|-48.08|-26.24|||ANCOVA|||||-26.24|-48.08|<0.0001
91546488|NCT00274469|182972489|NON_INFERIORITY|Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.|Odds Ratio (OR)|1.302||||0.386|TWO_SIDED|95.0|0.717|2.38||Null hypothesis: Fulvestrant has no difference with Anastrozole|Regression, Logistic||OR\>1 favours Fulvestrant|||2.380|0.717|0.386
91546489|NCT00274469|182972490|SUPERIORITY||Odds Ratio (OR)|1.021||||0.947|TWO_SIDED|95.0|0.556|1.874|||Regression, Logistic||OR\>1 favours Fulvestrant|||1.874|0.556|0.947
91546490|NCT00274469|182972491|SUPERIORITY||Hazard Ratio (HR)|0.6266||||0.0496|TWO_SIDED|95.0|0.3929|0.9991|||Log Rank||HR\<1 favours Fulvestrant|||0.9991|0.3929|0.0496
91546491|NCT00274469|182972492|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.54|1.0|||Log Rank||HR\<1 favours Fulvestrant|||1.00|0.54|0.05
91546492|NCT00274469|182972492|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.52|0.98|||Regression, Cox|Cox regression analysis of TTTF controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.98|0.52|0.04
91765471|NCT01425801|183419802|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.274|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.221|0.327|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.327|0.221|<0.0001
91765472|NCT03066596|183419828|SUPERIORITY|A generalized linear model (GLM) with logit link function was used to compare the percentage of participants with corrected actions taken and GEE method was used to account for within-clinic correlation. The null hypothesis is that there is no difference between groups in the the percentage of participants with corrected actions taken. With 530 participants at baseline, ≤10% attrition at 12 months, the study has greater than 80% power to detect a difference of 15 percentage points.|Odds Ratio (OR)|3.47|||<|0.001|TWO_SIDED|95.0|1.98|6.08||The p-values reported above represented the calculated value rather than predetermined thresholds for significance. Statistical significance was defined as a p-value less than 0.05.|GLM with GEE|||||6.08|1.98|<.001
91765473|NCT03066596|183419828|SUPERIORITY|This analysis is similar to analysis 1, however, the model adjusting for sex, age, race/ethnicity, symptom free days (at baseline), nurse screening results, clinic characteristics, visit type, caregiver education, and smoking exposure (at baseline).|Odds Ratio (OR)|3.66|||<|0.001|TWO_SIDED|95.0|1.97|6.82||The p-values reported above represented the calculated value rather than predetermined thresholds for significance. Statistical significance was defined as a p-value less than 0.05.|GLM with GEE|||||6.82|1.97|<.001
91546493|NCT00274469|182972493|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.47|0.92|||Log Rank||HR\<1 favours Fulvestrant|||0.92|0.47|0.01
91546494|NCT00274469|182972493|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.46|0.9|||Regression, Cox|Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.90|0.46|0.01
91546495|NCT00274469|182972494|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.041|TWO_SIDED|95.0|0.5|0.98|||Log Rank|||||0.98|0.50|0.041
91546496|NCT00274469|182972494|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.126|TWO_SIDED|95.0|0.54|1.08|||Regression, Cox|Cox regression analysis of OS controlling for baseline covariates|HR\<1 favours Fulvestrant|||1.08|0.54|0.126
91546497|NCT00100698|182972516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|6.0||0.049|TWO_SIDED|95.0|-38.0|-0.5|||repeated measures mixed effects ANCOVA|||||-0.5|-38|0.049
91546498|NCT05450458|182972534|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for KOOS score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Change Baseline to month 6|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.23||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|Post hoc pairwise comparisons were adjusted using the Bonferroni method, and the a priori significance level was set at 0.05|The value represents the intra-individual median KOOS improvement from baseline to month 6 after treatment. Changes were evaluated across time points within a single cohort.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve KOOS function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.23|0.15|<0.001
91546499|NCT05450458|182972535|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for IKDC score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Baseline to Month 6|0.18||||0.01|TWO_SIDED|95.0|0.12|0.24||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|The overall p-value is unadjusted. The a priori significance level was set at 0.05 to robustly control the Type I error|This value represents the intra-individual median IKDC improvement from baseline to 6 months after treatment. The analysis was conducted within a single cohort without comparator arms.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve IKDC function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.24|0.12|0.01
91546500|NCT05450458|182972537|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month IKDC score|Baseline to month 6|0.18||||0.001|TWO_SIDED|95.0|0.14|0.21||P-values from pairwise comparisons were adjusted using the Bonferroni method to control for multiple testing. The global p-value from the Friedman test was not adjusted. An a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median IKDC improvement from baseline to 6 months in 22 athletes with elevated BMI (≥25). No comparator group was used. Confidence interval calculated via bootstrap (resampling with 1,000 iterations).|The analysis was conducted under the null hypothesis of no change in knee function across time. Data normality was assessed using the Shapiro-Wilk test. Changes across the four time points (baseline, 15 days, 3 months, and 6 months) were evaluated using the Friedman test. Pairwise comparisons were performed post hoc using the Wilcoxon Signed-Rank Test with Bonferroni correction at a 5% significance threshold.||0.21|0.14|0.001
91546501|NCT05450458|182972537|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month KOOS score|Baseline to Month 6|18.5|||<|0.001|TWO_SIDED|95.0|13.0|22.0||The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median KOOS improvement from baseline to 6 months in 22 athletes with elevated BMI. CI calculated via bootstrap resampling (1,000 iterations). No comparator group was involved.|The analysis was conducted under the null hypothesis of no change in knee function between baseline and six months. The study was designed with sufficient power to detect clinically meaningful improvements, with significance determined at a conventional level||22|13|<0.001
91546502|NCT05480943|182972539|OTHER|chi-square tested correlation between CRP and thiamine deficiency.||||||0.6097||||||P\<=0.05 considered significant|Chi-squared|||For the subset of 123 participants with both C-reactive protein level and plasma thiamine levels (125 had C-reactive protein results but 2 were missing plasma thiamine levels), we used Chi-Square to test for association between those who were thiamine deficient and had elevated C-reactive protein (CRP) levels. A priori hypothesis was that inflammation would cause thiamine deficiency due to increased metabolic demands.||||0.6097
91546503|NCT01227265|182972553|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.4933|TWO_SIDED|95.0|-0.72|0.35|||cLDA|||||0.35|-0.72|0.4933
91546504|NCT01227265|182972553|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.3||||0.2364|TWO_SIDED|95.0|-0.86|0.21|||cLDA|||||0.21|-0.86|0.2364
91546505|NCT01227265|182972554|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|7.0||||0.244|TWO_SIDED|95.0|-4.17|18.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||18.05|-4.17|0.244
91765474|NCT03066596|183419829|SUPERIORITY|A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size \>0.29.|Ratio of Rate Ratios|1.13||||0.174|TWO_SIDED|95.0|0.95|1.34|||GLM with GEE|||3 month follow up||1.34|0.95|0.174
91546506|NCT01227265|182972554|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|6.5||||0.262|TWO_SIDED|95.0|-4.63|17.61||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||17.61|-4.63|0.262
91546507|NCT01227265|182972555|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.776|TWO_SIDED|95.0|-0.47|0.63|||cLDA|||||0.63|-0.47|0.776
91546508|NCT01227265|182972555|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.683|TWO_SIDED|95.0|-0.44|0.67|||cLDA|||||0.67|-0.44|0.683
91546509|NCT01227265|182972559|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.6968|TWO_SIDED|95.0|-0.92|0.61|||cLDA|||||0.61|-0.92|0.6968
91546510|NCT01227265|182972559|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.6142|TWO_SIDED|95.0|-0.57|0.97|||cLDA|||||0.97|-0.57|0.6142
91546511|NCT02910713|182972560|SUPERIORITY||Least Squares Mean Difference|-13.36|STANDARD_ERROR_OF_MEAN|1.999|<|0.0001|TWO_SIDED|95.0|-17.31|-9.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-9.40|-17.31|<0.0001
91546512|NCT02910713|182972561|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-0.40|-0.80|<0.0001
91546513|NCT04623775|182972588|SUPERIORITY||Risk Difference (RD)|-6.5|||||TWO_SIDED|95.0|-16.0|3.0||||||||3.0|-16.0|
91546514|NCT04623775|182972589|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|90.0|0.94|2.05|||Cochran-Mantel-Haenszel|||||2.05|0.94|
91546515|NCT02396199|182972629|SUPERIORITY||Proportion of participants|0.917||||0.006|ONE_SIDED|95.0|0.827|||One-sided test|Fisher Exact||Exact test, One-sided 95%, with lower limit (0.827)||||0.827|0.006
91546516|NCT04455035|182972647|OTHER|ttest||||||0.0088|||||||t-test, 2 sided|||||||0.0088
91546517|NCT04455035|182972648|OTHER|ttest||||||1e-05|||||||t-test, 2 sided|||||||0.00001
91546518|NCT03897686|182972709|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0003|TWO_SIDED|95.0|-274.96|-83.65||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||"It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.~The null hypothesis states that there is no difference between treatment groups in mean change from baseline to Week 25 in the total WOMAC score."||-83.65|-274.96|0.00030
91546519|NCT03897686|182972709|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~1\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade II"||-53.50|-305.11|0.0017
91546520|NCT03897686|182972709|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~2\) Group A (NOLTREX™) OA grade II versus Group A (NOLTREX™) ОА grade III"||123.82|-197.83|0.9324
91546521|NCT03897686|182972709|SUPERIORITY||LS-means difference|-216.31|STANDARD_ERROR_OF_MEAN|75.01||0.0233|TWO_SIDED|95.0|-411.37|-21.25||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~3\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade III"||-21.25|-411.37|0.0233
91546522|NCT03897686|182972709|SUPERIORITY||LS-means difference|142.3|STANDARD_ERROR_OF_MEAN|81.89||0.3082|TWO_SIDED|95.0|-70.63|355.22||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~4\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade II"||355.22|-70.63|0.3082
91546523|NCT03897686|182972709|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~5\) versus Group B (Placebo) OA grade II versus Group B (Placebo) ОА grade III"||123.82|-197.83|0.9324
91546524|NCT03897686|182972709|SUPERIORITY||Slope|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~6\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade III"||-53.50|-305.11|0.0017
91546525|NCT03897686|182972710|SUPERIORITY|\[Not specified\]|S-means difference|-143.39|STANDARD_ERROR_OF_MEAN|46.88||0.00267|TWO_SIDED|95.0|-236.09|-50.69||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.||-50.69|-236.09|0.00267
91546526|NCT03897686|182972711|SUPERIORITY||LS-means difference|-13.23|STANDARD_ERROR_OF_MEAN|9.995||0.16786|TWO_SIDED|95.0|-32.096|5.638||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 3 (week 6)||5.638|-32.096|0.16786
91546527|NCT03897686|182972711|SUPERIORITY||LS-means difference|-26.695|STANDARD_ERROR_OF_MEAN|9.995||0.00847|TWO_SIDED|95.0|-46.46|-6.93||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 4 (week 13)||-6.93|-46.46|0.00847
91546528|NCT03897686|182972711|SUPERIORITY||LS-means difference|-33.96|STANDARD_ERROR_OF_MEAN|10.29||0.00123|TWO_SIDED|95.0|-54.31|-13.62||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-13.62|-54.31|0.00123
91546529|NCT03897686|182972712|SUPERIORITY||LS-means difference|-0.146|STANDARD_ERROR_OF_MEAN|5.121||0.97733|TWO_SIDED|95.0|-10.271|9.98||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 3||9.980|-10.271|0.97733
91546530|NCT03897686|182972712|SUPERIORITY||LS-means difference|-14.5|STANDARD_ERROR_OF_MEAN|5.29||0.00693|TWO_SIDED|95.0|-24.95|-4.04||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 4||-4.04|-24.95|0.00693
91546531|NCT03897686|182972712|SUPERIORITY||LS-means difference|-16.18|STANDARD_ERROR_OF_MEAN|4.68||0.00073|TWO_SIDED|95.0|-25.44|-6.92||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-6.92|-25.44|0.00073
91546532|NCT03897686|182972712|SUPERIORITY||LS-means difference|-57.14|STANDARD_ERROR_OF_MEAN|32.1||0.07725|TWO_SIDED|95.0|-120.62|6.33||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 3||6.33|-120.62|0.07725
91546533|NCT03897686|182972712|SUPERIORITY||LS-means difference|-103.27|STANDARD_ERROR_OF_MEAN|33.92||0.00279|TWO_SIDED|95.0|-170.35|-36.2||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 4||-36.20|-170.35|0.00279
91546534|NCT03897686|182972712|SUPERIORITY||LS-means difference|-133.29|STANDARD_ERROR_OF_MEAN|35.26||0.00023|TWO_SIDED|95.0|-203.03|-63.55||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 5||-63.55|-203.03|0.00023
91546535|NCT03897686|182972713|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
91546536|NCT03897686|182972714|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
91546537|NCT03897686|182972716|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 3 (week 6).||||0.050
91546538|NCT03897686|182972716|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 4 (week 13).||||0.004
91546539|NCT04505774|182972731|SUPERIORITY|||||||0.6778|||||||t-test, 2 sided|||||||.6778
91546540|NCT04505774|182972731|SUPERIORITY|||||||0.6292|||||||t-test, 2 sided|||||||.6292
91546541|NCT04505774|182972731|SUPERIORITY|||||||0.6858|||||||t-test, 2 sided|||||||.6858
91546542|NCT04505774|182972731|SUPERIORITY|||||||0.1351|||||||t-test, 2 sided|||||||.1351
91546543|NCT04505774|182972732|SUPERIORITY|||||||0.1959|||||||Chi-squared|||||||.1959
91546544|NCT04505774|182972732|SUPERIORITY|||||||0.9496|||||||Chi-squared|||||||0.9496
91546545|NCT04505774|182972732|SUPERIORITY|||||||0.9902|||||||Chi-squared|||||||.9902
91546546|NCT04505774|182972732|SUPERIORITY|||||||0.0814|||||||Chi-squared|||||||.0814
91546547|NCT04505774|182972733|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91546548|NCT04505774|182972733|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91546549|NCT04505774|182972733|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91546550|NCT04505774|182972734|SUPERIORITY|||||||0.0577|||||||Chi-squared|||||||.0577
91546551|NCT04505774|182972734|SUPERIORITY|||||||0.5015|||||||Chi-squared|||||||.5015
91546552|NCT04505774|182972734|SUPERIORITY|||||||0.5892|||||||Chi-squared|||||||.5892
91546553|NCT04505774|182972734|SUPERIORITY|||||||0.1714|||||||Chi-squared|||||||.1714
91546554|NCT04505774|182972735|SUPERIORITY|||||||0.0732|||||||Chi-squared|||||||.0732
91546555|NCT04505774|182972735|SUPERIORITY|||||||0.9018|||||||Chi-squared|||||||.9018
91546556|NCT04505774|182972735|SUPERIORITY|||||||0.5075|||||||Chi-squared|||||||.5075
91546557|NCT04505774|182972735|SUPERIORITY|||||||0.145|||||||Chi-squared|||||||.1450
91546558|NCT04505774|182972736|SUPERIORITY|||||||0.8837|||||||Chi-squared|||||||.8837
91546559|NCT04505774|182972736|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91546560|NCT04505774|182972736|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91546561|NCT04505774|182972736|SUPERIORITY|||||||0.5343|||||||Chi-squared|||||||.5343
91546562|NCT04505774|182972737|SUPERIORITY|||||||0.6636|||||||t-test, 2 sided|||||||.6636
91546563|NCT04505774|182972737|SUPERIORITY|||||||0.5878|||||||t-test, 2 sided|||||||.5878
91546564|NCT04505774|182972737|SUPERIORITY|||||||0.7148|||||||t-test, 2 sided|||||||.7148
91546565|NCT04505774|182972737|SUPERIORITY|||||||0.1117|||||||t-test, 2 sided|||||||.1117
91546566|NCT04505774|182972738|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||.6780
91546567|NCT04505774|182972738|SUPERIORITY|||||||0.6638|||||||t-test, 2 sided|||||||.6638
91546568|NCT04505774|182972738|SUPERIORITY|||||||0.7645|||||||t-test, 2 sided|||||||.7645
91546569|NCT04505774|182972738|SUPERIORITY|||||||0.0987|||||||t-test, 2 sided|||||||0.0987
91546570|NCT04505774|182972739|SUPERIORITY|||||||0.4016|||||||t-test, 2 sided|||||||.4016
91546571|NCT04505774|182972739|SUPERIORITY|||||||0.5815|||||||t-test, 2 sided|||||||.5815
91546572|NCT04505774|182972739|SUPERIORITY|||||||0.9085|||||||t-test, 2 sided|||||||.9085
91546573|NCT04505774|182972739|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||.0820
91546574|NCT04505774|182972740|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||.3135
91546575|NCT04505774|182972740|SUPERIORITY|||||||0.9581|||||||Chi-squared|||||||.9581
91546576|NCT04505774|182972740|SUPERIORITY|||||||0.9661|||||||Chi-squared|||||||.9661
91546577|NCT04505774|182972740|SUPERIORITY|||||||0.1073|||||||Chi-squared|||||||.1073
91546578|NCT04505774|182972741|SUPERIORITY|||||||0.3575|||||||Chi-squared|||||||.3575
91546579|NCT04505774|182972741|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||.5910
91546580|NCT04505774|182972741|SUPERIORITY|||||||0.867|||||||Chi-squared|||||||.8670
91546581|NCT04505774|182972741|SUPERIORITY|||||||0.0645|||||||Chi-squared|||||||.0645
91546582|NCT05386355|182972742|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.59|5.35|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||5.35|0.59|
91546583|NCT05386355|182972743|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.65|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||1.65|0.42|
91546584|NCT05386355|182972744|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.638|TWO_SIDED|95.0|-1.19|0.73|||Mixed Models Analysis|The analytical method was based on a linear mixed model adjusting for baseline SAGE vaccine hesitancy composite scores and random clinic effect.||||0.73|-1.19|0.638
91546585|NCT04788537|182972745|SUPERIORITY|Linear mixed model regression|Slope|-1.58||||0.006|TWO_SIDED||||||Mixed Models Analysis||Slope reported is for Time x Group Interaction|||||.006
91546586|NCT03775109|182972761|SUPERIORITY||Mean Difference (Net)|16.7||||0.248|TWO_SIDED|95.0|-11.2|44.5||The threshold for statistical significance was p = 0.05|Chi-squared||Difference = Canakinumab - Placebo|It is estimated that improvement of histological alcoholic steatohepatitis will occur in 40% of patients treated with placebo and 80% of patients treated with Canakinumab. A trial with 80% power to detect a difference at the P \< 0.05 threshold would require 23 patients in each arm, 46 in total. Assuming a drop-out rate of 10%, we will recruit 52 patients in total (26 patients per group).||44.5|-11.2|0.248
91546587|NCT03775109|182972762|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
91546588|NCT03775109|182972763|SUPERIORITY||Odds Ratio (OR)|3.133|||||TWO_SIDED|95.0|0.121|81.004||||||||81.004|0.121|
91546589|NCT03775109|182972764|SUPERIORITY||Odds Ratio (OR)|1.887|||||TWO_SIDED|95.0|0.357|9.965||||||||9.965|0.357|
91546590|NCT03775109|182972767|SUPERIORITY|||||||0.27|||||||ANCOVA|Change in log-transformed serum bilirubin from baseline to day 28. 49 participants were included in this analysis.||||||0.270
91546591|NCT03775109|182972768|SUPERIORITY|||||||0.0349|||||||ANCOVA|ANCOVA model: MELD score at Day 28 = intercept + treatment group indicator + baseline MELD score. 49 patients have data at Day 28 and baseline.||||||0.03490
91546592|NCT03775109|182972769|SUPERIORITY||Odds Ratio (OR)|5.088|||||TWO_SIDED|95.0|1.558|16.624|||||Ordinal logistic regression (proportional odds) model. GAHS at day 28 = intercept + treatment group indicator + baseline GAHS measurement. 48 participants have GAHS data at baseline and day 28.|||16.624|1.558|
91546593|NCT03775109|182972770|SUPERIORITY|||||||0.343|||||||ANCOVA|ANCOVA model: mDF score at day 28 = intercept + treatment group indicator + baseline mDF score.||Natural log transformation used for both baseline and day 28 measurements. 49 participants have mDF measurements at baseline and day 28.||||0.343
91546594|NCT03775109|182972771|SUPERIORITY||Mean Difference (Net)|0.083|||||TWO_SIDED|95.0|-0.529|0.696|||||difference = canakinumab - placebo. natural log transformation used.|||0.696|-0.529|
91546595|NCT03775109|182972772|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91546596|NCT03775109|182972773|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91546597|NCT03775109|182972774|SUPERIORITY||Cox Proportional Hazard|1.046|||||TWO_SIDED|95.0|0.147|7.424||||||||7.424|0.147|
91546598|NCT03775109|182972782|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
91546599|NCT03775109|182972783|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.388|0.127|||||Difference = Canakinumab - Placebo|||0.127|-0.388|
91546600|NCT03775109|182972784|SUPERIORITY||Odds Ratio (OR)|4.012|||||TWO_SIDED|95.0|0.693|23.219||||||||23.219|0.693|
91546601|NCT03775109|182972785|SUPERIORITY||Odds Ratio (OR)|4.543|||||TWO_SIDED|95.0|0.543|38.043||||||||38.043|0.543|
91546602|NCT03775109|182972786|SUPERIORITY||Odds Ratio (OR)|1.745|||||TWO_SIDED|95.0|0.456|6.558||||||||6.558|0.456|
91546603|NCT03775109|182972787|SUPERIORITY||Odds Ratio (OR)|0.977|||||TWO_SIDED|95.0|0.281|3.397||||||||3.397|0.281|
91546604|NCT03775109|182972788|SUPERIORITY||Odds Ratio (OR)|0.768|||||TWO_SIDED|95.0|0.238|2.479||||||||2.479|0.238|
91546605|NCT05691452|182972794|SUPERIORITY||Mean Difference (Net)|20.05||||0.578|TWO_SIDED|95.0|-50.68|90.78||Generalized linear models generated estimated mean differences in the post-intervention values controlling for the baseline assessments.|Regression, Linear|||||90.78|-50.68|0.578
91546606|NCT05691452|182972795|SUPERIORITY||Mean Difference (Net)|-21.2||||0.61|TWO_SIDED|95.0|-101.9|59.5|||Regression, Linear|||||59.5|-101.9|0.61
91546607|NCT05691452|182972796|SUPERIORITY||Mean Difference (Net)|1.55||||0.674|TWO_SIDED|95.0|-5.68|8.78|||Regression, Linear|||||8.78|-5.68|0.674
91546608|NCT05691452|182972797|SUPERIORITY||Mean Difference (Net)|-21.6||||0.013|TWO_SIDED|95.0|-38.5|-4.59|||Regression, Linear|||||-4.59|-38.5|.013
91546609|NCT05691452|182972798|SUPERIORITY||Mean Difference (Net)|0.387||||0.29|TWO_SIDED|95.0|-0.335|1.109|||Regression, Linear|||||1.109|-0.335|0.29
91546610|NCT05691452|182972799|SUPERIORITY||Mean Difference (Net)|-0.203||||0.701|TWO_SIDED|95.0|-1.24|0.833|||Regression, Linear|||||0.833|-1.24|0.701
91765475|NCT03066596|183419829|SUPERIORITY|A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size \>0.29.|Ratio of Rate Ratios|1.04||||0.741|TWO_SIDED|95.0|0.85|1.27|||GLM with GEE|||6 month follow up||1.27|0.85|0.741
91546611|NCT05691452|182972800|SUPERIORITY||Mean Difference (Net)|-21.45||||0.376|TWO_SIDED|95.0|-68.99|26.08|||Regression, Linear|||||26.08|-68.99|0.376
91546612|NCT03069313|182972903|OTHER|Paired t-test|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
91546613|NCT03069313|182972904|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
91546614|NCT03069313|182972905|OTHER|This analysis is comparing SWB before and after treatment.||||||0.133|||||||t-test, 2 sided|||||||0.133
91546615|NCT03069313|182972905|OTHER|||||||0.056|||||||t-test, 2 sided|||This analysis is comparing EWB before and after treatment.||||0.056
91546616|NCT03069313|182972905|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing PWB before and after treatment.||||<0.0001
91546617|NCT03069313|182972905|OTHER|||||||0.09|||||||t-test, 2 sided|||This analysis is comparing FWB before and after treatment.||||0.09
91546618|NCT03069313|182972905|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing ESS before and after treatment.||||<0.0001
91546619|NCT03580369|182972907|SUPERIORITY||LS Mean|-8.002|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-10.576|-5.428|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.428|-10.576|<.0001
91546620|NCT03580369|182972907|SUPERIORITY||LS mean|0.672|STANDARD_ERROR_OF_MEAN|0.939||0.7628|TWO_SIDED|95.0|-1.169|2.513|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.513|-1.169|0.7628
91546621|NCT03580369|182972907|SUPERIORITY||LS Mean|-7.964|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-10.522|-5.047|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.047|-10.522|<.0001
91546622|NCT03580369|182972907|SUPERIORITY||LS mean|0.71|STANDARD_ERROR_OF_MEAN|0.933||0.7768|TWO_SIDED|95.0|-1.118|2.538|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.538|-1.118|0.7768
91546623|NCT03580369|182972909|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.68|||<|0.0001|TWO_SIDED|95.0|2.667|12.095|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.095|2.667|<.0001
91546624|NCT03580369|182972909|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.84||||0.843|TWO_SIDED|95.0|0.598|1.18|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.180|0.598|0.8430
91546625|NCT03580369|182972909|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.734|||<|0.0001|TWO_SIDED|95.0|2.694|12.207|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.207|2.694|<.0001
91546626|NCT03580369|182972909|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|0.848||||0.8312|TWO_SIDED|95.0|0.605|1.188|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.188|0.605|0.8312
91546627|NCT03580369|182972910|SUPERIORITY||LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|0.597|<|0.0001|TWO_SIDED|95.0|-4.271|-1.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||-1.929|-4.271|<.0001
91546628|NCT03580369|182972910|SUPERIORITY||LS Mean|0.419|STANDARD_ERROR_OF_MEAN|0.428||0.8366|TWO_SIDED|95.0|-0.419|1.258|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.258|-0.419|0.8366
91546629|NCT03580369|182972910|SUPERIORITY|Adults|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.594|<|0.0001|TWO_SIDED|95.0|-4.295|-1.966|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-1.966|-4.295|<.0001
91546630|NCT03580369|182972910|SUPERIORITY||LS Mean|0.389|STANDARD_ERROR_OF_MEAN|0.425||0.8201|TWO_SIDED|95.0|-0.444|1.222|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.222|-0.444|0.8201
91546631|NCT03580369|182972912|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|2.747|||<|0.0001|TWO_SIDED|95.0|1.621|4.656|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||4.656|1.621|<.0001
91546632|NCT03580369|182972912|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.836||||0.8586|TWO_SIDED|95.0|0.603|1.159|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.159|0.603|0.8586
91546633|NCT03580369|182972912|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.261|||<|0.0001|TWO_SIDED|95.0|1.929|5.513|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||5.513|1.929|<.0001
91765476|NCT03066596|183419829|SUPERIORITY|A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size \>0.29.|Ratio of Rate Ratios|1.03||||0.724|TWO_SIDED|95.0|0.85|1.25|||GLM with GEE|||9 month follow up||1.25|0.85|0.724
91765477|NCT03066596|183419829|SUPERIORITY|A generalized linear model (GLM) with generalized estimating equations (GEE) was used to compare changes over time between the two groups in symptom-free days (SFDs) during the past two weeks, accounting for within-subject correlation. The null hypothesis at each time point was that there is no difference between groups in the change in SFDs. With 530 participants at baseline, ≤10% attrition at 12 months, the study has 80% power to detect a standardized effect size \>0.29.|Ratio of Rate Ratios|1.12||||0.229|TWO_SIDED|95.0|0.93|1.34|||GLM with GEE|||12 month follow up||1.34|0.93|0.229
91765478|NCT03066596|183419829|SUPERIORITY|This analysis is similar to Analysis 1, with adjustment for baseline outcome (symptom-free days) and seasonality.|Ratio of Rate Ratios|1.13||||0.186|TWO_SIDED|95.0|0.94|1.34|||GLM with GEE|||3 month follow up||1.34|0.94|0.186
91765479|NCT03066596|183419829|SUPERIORITY|This analysis is similar to Analysis 2, with adjustment for baseline outcome (symptom-free days) and seasonality.|Ratio of Rate Ratios|1.04||||0.744|TWO_SIDED|95.0|0.84|1.27|||GLM with GEE|||6 month follow up||1.27|0.84|0.744
91765480|NCT03066596|183419829|SUPERIORITY|This analysis is similar to Analysis 3, with adjustment for baseline outcome (symptom-free days) and seasonality.|Ratio of Rate Ratios|1.03||||0.765|TWO_SIDED|95.0|0.85|1.25|||GLM with GEE|||9 month follow up||1.25|0.85|0.765
91765481|NCT03066596|183419829|SUPERIORITY|This analysis is similar to Analysis 4, with adjustment for baseline outcome (symptom-free days) and seasonality.|Ratio of Rate Ratios|1.11||||0.241|TWO_SIDED|95.0|0.93|1.33|||GLM with GEE|||12 month follow up||1.33|0.93|0.241
91546634|NCT03580369|182972912|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.992||||0.519|TWO_SIDED|95.0|0.717|1.373|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.373|0.717|0.5190
91765482|NCT00666406|183419868|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.173|||||TWO_SIDED|90.0|1.089|1.262||||||||1.262|1.089|
91765483|NCT00666406|183419869|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.139|||||TWO_SIDED|90.0|1.043|1.243||||||||1.243|1.043|
91765484|NCT00666406|183419870|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.06|||||TWO_SIDED|90.0|0.866|1.297||||||||1.297|0.866|
91765485|NCT00666406|183419871|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.071|||||TWO_SIDED|90.0|0.972|1.179||||||||1.179|0.972|
91765486|NCT00666406|183419872|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.171|||||TWO_SIDED|90.0|1.099|1.247||||||||1.247|1.099|
91546635|NCT03580369|182972913|SUPERIORITY||Risk Ratio (RR)|1.323|||<|0.0001|TWO_SIDED|95.0|1.183|1.48|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.480|1.183|<.0001
91546636|NCT03580369|182972913|SUPERIORITY||Risk Ratio (RR)|0.975||||0.7469|TWO_SIDED|95.0|0.904|1.051|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.051|0.904|0.7469
91546637|NCT03580369|182972913|SUPERIORITY||Risk Ratio (RR)|1.376|||<|0.0001|TWO_SIDED|95.0|1.23|1.54|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.540|1.230|<.0001
91765487|NCT00666406|183419873|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.135|||||TWO_SIDED|90.0|1.092|1.18||||||||1.180|1.092|
91765488|NCT00666406|183419874|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.036|||||TWO_SIDED|90.0|0.857|1.253||||||||1.253|0.857|
91765489|NCT00666406|183419875|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.093|||||TWO_SIDED|90.0|1.007|1.186||||||||1.186|1.007|
91765490|NCT00666406|183419876|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.854|||||TWO_SIDED|90.0|0.798|0.913||||||||0.913|0.798|
91765491|NCT00666406|183419877|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.881|||||TWO_SIDED|90.0|0.847|0.916||||||||0.916|0.847|
91765492|NCT00666406|183419878|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.799|1.164||||||||1.164|0.799|
91765493|NCT00666406|183419879|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.915|||||TWO_SIDED|90.0|0.841|0.995||||||||0.995|0.841|
91765494|NCT00666406|183419880|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.177|||||TWO_SIDED|90.0|1.104|1.256||||||||1.256|1.104|
91765495|NCT00666406|183419881|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.039|1.277||||||||1.277|1.039|
91765496|NCT00666406|183419882|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.182|||||TWO_SIDED|90.0|1.029|1.359||||||||1.359|1.029|
91765497|NCT00666406|183419883|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.01|1.27||||||||1.270|1.010|
91765498|NCT00666406|183419884|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.008|||||TWO_SIDED|90.0|0.969|1.05||||||||1.050|0.969|
91765499|NCT00666406|183419885|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.843|1.102||||||||1.102|0.843|
91765500|NCT00666406|183419886|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.038|||||TWO_SIDED|90.0|0.926|1.163||||||||1.163|0.926|
91765501|NCT00666406|183419887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.015|||||TWO_SIDED|90.0|0.901|1.144||||||||1.144|0.901|
91765502|NCT00666406|183419888|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.178|||||TWO_SIDED|90.0|1.106|1.254||||||||1.254|1.106|
91765503|NCT00666406|183419889|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.038|1.279||||||||1.279|1.038|
91765504|NCT00666406|183419890|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.183|||||TWO_SIDED|90.0|1.027|1.362||||||||1.362|1.027|
91765505|NCT00666406|183419891|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.012|1.27||||||||1.270|1.012|
91765506|NCT00666406|183419892|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.009|||||TWO_SIDED|90.0|0.964|1.056||||||||1.056|0.964|
91765507|NCT00666406|183419893|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.971|||||TWO_SIDED|90.0|0.849|1.112||||||||1.112|0.849|
91765508|NCT00666406|183419894|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.02|||||TWO_SIDED|90.0|0.938|1.109||||||||1.109|0.938|
91765509|NCT00666406|183419895|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.996|||||TWO_SIDED|90.0|0.894|1.111||||||||1.111|0.894|
91546638|NCT03580369|182972913|SUPERIORITY||Risk Ratio (RR)|1.014||||0.3586|TWO_SIDED|95.0|0.941|1.092|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.092|0.941|0.3586
91546639|NCT02278562|182973004|SUPERIORITY|||||||0.37||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.37
91765510|NCT00666406|183419896|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.0|||||TWO_SIDED|90.0|1.0|1.0||||||||1.000|1.000|
91546640|NCT02278562|182973004|SUPERIORITY|||||||0.955||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933.||||0.955
91546641|NCT05374837|182973050|SUPERIORITY||Odds Ratio (OR)|0.9585||||0.145|TWO_SIDED|95.0|0.4276|2.1485||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in control group at endline.|||2.1485|0.4276|0.145
91546642|NCT05374837|182973050|SUPERIORITY||Odds Ratio (OR)|0.9669||||0.145|TWO_SIDED|95.0|0.43|2.1742||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in intervention group at endline.|||2.1742|0.43|0.145
91546643|NCT05374837|182973051|SUPERIORITY||Odds Ratio (OR)|0.3084||||0.179|TWO_SIDED|95.0|0.1977|0.481||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.481|0.1977|0.179
91546644|NCT05374837|182973051|SUPERIORITY||Odds Ratio (OR)|0.438||||0.179|TWO_SIDED|95.0|0.2983|0.6431||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.6431|0.2983|0.179
91546645|NCT05374837|182973057|SUPERIORITY|||||||0.054||||||A priori threshold for statistical significance \<0.05.|Chi-squared|||||||0.054
91546646|NCT05374837|182973058|SUPERIORITY|||||||0.65||||||A priori threshold for statistical significance \<0.05|Chi-squared|||||||0.65
91546647|NCT05406921|182973088|SUPERIORITY||Mean Difference (Net)|0.32|||<|0.05|TWO_SIDED||||||ANOVA|||This was a feasibility study and not powered to detect significant differences pre-/post-intervention.||||<0.05
91546648|NCT04299009|182973090|OTHER|multilevel linear models with Epworth sleepiness score scores as the dependent variable; treatment block (BLT vs sBLT) as a fixed effect; treatment sequence as a covariate; and participant intercept as a random effect.|regression coefficient|2.45|||<|0.05|TWO_SIDED|95.0|-0.3|5.19|||Mixed Models Analysis|||||5.19|-0.30|<0.05
91546649|NCT04838262|182973146|OTHER|||||||0.57|||||||Regression, Linear|||||||0.57
91546650|NCT04838262|182973146|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
91546651|NCT00792636|182973201|SUPERIORITY_OR_OTHER||Least-squares mean|-1.7|||||TWO_SIDED|95.0|-3.2|-0.3|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-3.2|
91546652|NCT00792636|182973201|SUPERIORITY_OR_OTHER||Least-squares mean|-0.9|||||TWO_SIDED|95.0|-2.2|0.3|||||Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.3|-2.2|
91546653|NCT00792636|182973201|SUPERIORITY_OR_OTHER||Least-squares mean|-1.9|||||TWO_SIDED|95.0|-3.4|-0.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.4|-3.4|
91546654|NCT00792636|182973201|SUPERIORITY_OR_OTHER||Least-squares mean|-0.7|||||TWO_SIDED|95.0|-2.0|0.6|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.6|-2.0|
91546655|NCT00792636|182973202|SUPERIORITY_OR_OTHER||Least-squares mean|-2.1|||||TWO_SIDED|95.0|-3.4|-0.8|||||Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.8|-3.4|
91546656|NCT00792636|182973202|SUPERIORITY_OR_OTHER||Least-squares mean|-1.5|||||TWO_SIDED|95.0|-2.6|-0.3|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-2.6|
91546657|NCT00792636|182973203|SUPERIORITY_OR_OTHER||Least-squares mean|0.4|||||TWO_SIDED|95.0|-1.6|2.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.4|-1.6|
91546658|NCT00792636|182973203|SUPERIORITY_OR_OTHER||Least-squares mean|0.5|||||TWO_SIDED|95.0|-1.2|2.2|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.2|
91546659|NCT00792636|182973204|SUPERIORITY_OR_OTHER||Least-squares mean|0.3|||||TWO_SIDED|95.0|-1.7|2.2|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.7|
91546660|NCT00792636|182973204|SUPERIORITY_OR_OTHER||Least-squares mean|0.8|||||TWO_SIDED|95.0|-0.9|2.5|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.5|-0.9|
91546661|NCT00792636|182973209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
91546662|NCT00792636|182973209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
91546663|NCT00792636|182973210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|0.6|
91546664|NCT00792636|182973210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.2||||||||2.2|0.7|
91546665|NCT00792636|182973211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|13.6||||||||13.6|0.1|
91765511|NCT00666406|183419897|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.303|||||TWO_SIDED|90.0|0.841|2.02||||||||2.020|0.841|
91765512|NCT00666406|183419898|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.724|||||TWO_SIDED|90.0|0.304|1.728||||||||1.728|0.304|
91546666|NCT00792636|182973211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|0.3|25.6||||||||25.6|0.3|
91546667|NCT00792636|182973212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.7||||||||3.7|0.5|
91546668|NCT00792636|182973212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.6|4.2||||||||4.2|0.6|
91546669|NCT00792636|182973213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.84|1.54||||||||1.54|0.84|
91546670|NCT00792636|182973213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.01|1.83||||||||1.83|1.01|
91546671|NCT00792636|182973214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.65|1.21||||||||1.21|0.65|
91546672|NCT00792636|182973214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.88|1.6||||||||1.60|0.88|
91765513|NCT00666406|183419899|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.059|||||TWO_SIDED|90.0|0.442|2.539||||||||2.539|0.442|
91765514|NCT00666406|183419900|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.862|||||TWO_SIDED|90.0|0.807|0.92||||||||0.920|0.807|
91546673|NCT04757610|182973274|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.023||0.284421|TWO_SIDED|95.0|-3.1|0.91|||MMRM|||||0.91|-3.10|0.284421
91546674|NCT04757610|182973274|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.025||0.066678|TWO_SIDED|95.0|-3.9|0.13|||MMRM|||||0.13|-3.90|0.066678
91546675|NCT00593489|182973300|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.24|||Poisson Regression|||The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate||1.24|0.8|0.96
91546676|NCT03690206|182973388|SUPERIORITY||Difference to Placebo|-2.28||||0.0039|TWO_SIDED|95.0|-3.83|-0.73|||Mixed Models Analysis|||||-0.73|-3.83|0.0039
91546677|NCT03690206|182973388|SUPERIORITY||Difference to Placebo|-0.91||||0.27|TWO_SIDED|95.0|-2.52|0.71|||Mixed Models Analysis|||||0.71|-2.52|0.2700
91546678|NCT03690206|182973389|SUPERIORITY||Difference to Placebo|26.6||||0.0243|TWO_SIDED|95.0|4.3|48.9|||Cochran-Mantel-Haenszel|||||48.9|4.3|0.0243
91546679|NCT03690206|182973389|SUPERIORITY||Difference to Placebo|5.5||||0.6255|TWO_SIDED|95.0|-16.2|27.1|||Cochran-Mantel-Haenszel|||||27.1|-16.2|0.6255
91546680|NCT03690206|182973390|SUPERIORITY||Difference to Placebo|31.7||||0.0043|TWO_SIDED|95.0|11.4|51.9|||Cochran-Mantel-Haenszel|||||51.9|11.4|0.0043
91546681|NCT03690206|182973390|SUPERIORITY||Difference to Placebo|13.3||||0.1675|TWO_SIDED|95.0|-5.4|32.0|||Cochran-Mantel-Haenszel|||||32.0|-5.4|0.1675
91546682|NCT03690206|182973392|SUPERIORITY||Difference to Placebo|14.1||||0.016|TWO_SIDED|95.0|2.5|25.6|||Cochran-Mantel-Haenszel|||||25.6|2.5|0.0160
91546683|NCT03690206|182973392|SUPERIORITY||Difference to Placebo|11.2||||0.0424|TWO_SIDED|95.0|0.7|21.6|||Cochran-Mantel-Haenszel|||||21.6|0.7|0.0424
91546684|NCT06143670|182973450|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
91546685|NCT06143670|182973451|SUPERIORITY||Adjusted Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|-19.6|-14.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-14.1|-19.6|<0.0001
91546686|NCT06143670|182973452|SUPERIORITY||Adjusted Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-18.9|-13.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-13.1|-18.9|<0.0001
91546687|NCT06143670|182973452|SUPERIORITY||Adjusted Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-19.9|-15.3|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-15.3|-19.9|<0.0001
91546688|NCT06143670|182973453|SUPERIORITY||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.35|-0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.20|-0.35|<0.0001
91546689|NCT06143670|182973453|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.26|<0.0001
91546690|NCT06143670|182973453|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.36|-0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.22|-0.36|<0.0001
91546691|NCT06143670|182973454|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.28|-0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.16|-0.28|<0.0001
91546692|NCT06143670|182973454|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|-0.21|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.10|-0.21|<0.0001
91546693|NCT06143670|182973454|SUPERIORITY||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.3|-0.18|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.18|-0.30|<0.0001
91546694|NCT06143670|182973455|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.15|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.10|-0.15|<0.0001
91546695|NCT06143670|182973455|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.17|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.17|<0.0001
91765515|NCT00666406|183419901|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.855|||||TWO_SIDED|90.0|0.73|1.002||||||||1.002|0.730|
91765516|NCT00666406|183419902|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.984|||||TWO_SIDED|90.0|0.788|1.228||||||||1.228|0.788|
91765517|NCT00666406|183419903|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.911|||||TWO_SIDED|90.0|0.8|1.039||||||||1.039|0.800|
91765518|NCT01369784|183419961|SUPERIORITY_OR_OTHER|||||||0.812|||||||Fisher Exact|||||||0.812
91765519|NCT01369784|183419962|SUPERIORITY_OR_OTHER|||||||0.612|||||||Chi-squared|||||||0.612
91546696|NCT06143670|182973455|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.16|-0.11|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.11|-0.16|<0.0001
91546697|NCT06143670|182973456|SUPERIORITY||Adjusted Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.74|-0.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.53|-0.74|<0.0001
91546698|NCT06143670|182973456|SUPERIORITY||Adjusted Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.74|-0.56|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.56|-0.74|<0.0001
91546699|NCT06143670|182973456|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.77|-0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.58|-0.77|<0.0001
91546700|NCT00837369|182973462|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Compare the differences in sensitivity between myocardial perfusion and wall motion for detecting stenosis.|Chi-squared|||||||<0.001
91546701|NCT00837369|182973462|SUPERIORITY||||||<|0.001||||||Compare the sensitivity of myocardial perfusion in detecting stenosis within the first 4 minutes after regadenoson bolus injection to that of wall motion|Chi-squared|||||||<0.001
91546702|NCT05343390|182973540|SUPERIORITY||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|16.1|25.1|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||25.1|16.1|<0.001
91546703|NCT05343390|182973541|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.001|TWO_SIDED|95.0|5.9|16.4|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||16.4|5.9|<0.001
91546704|NCT05343390|182973542|SUPERIORITY||Rate Ratio|1.22||||0.14|TWO_SIDED|95.0|0.93|1.6|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.60|0.93|0.14
91546705|NCT05343390|182973543|SUPERIORITY||Rate Ratio|1.37||||0.006|TWO_SIDED|95.0|1.1|1.71|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.71|1.10|0.006
91765520|NCT01369784|183419963|SUPERIORITY_OR_OTHER|||||||0.402|||||||Chi-squared|||||||0.402
91765521|NCT01369784|183419964|SUPERIORITY_OR_OTHER|||||||0.557|||||||Chi-squared|||||||0.557
91546706|NCT05343390|182973544|SUPERIORITY||Rate Ratio|2.29||||0.013|TWO_SIDED|95.0|1.19|4.4|||Mixed Models Analysis|Negative binomial mixed-effect model||||4.40|1.19|0.013
91546707|NCT05343390|182973545|SUPERIORITY||Rate Ratio|1.45||||0.01|TWO_SIDED|95.0|1.1|1.92|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.92|1.10|0.01
91546708|NCT05343390|182973546|SUPERIORITY||Rate Ratio|1.28||||0.12|TWO_SIDED|95.0|0.94|1.76|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.76|0.94|0.12
91546709|NCT00739648|182973553|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7282|TWO_SIDED|90.0|0.86|1.39|||Regression, Linear|negative binomial regression model||||1.39|0.86|0.7282
91546710|NCT00739648|182973555|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.2||||0.9768|TWO_SIDED|90.0|-27.8|-2.66|||Mixed Models Analysis|||||-2.66|-27.8|0.9768
91546711|NCT00739648|182973556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.3||||0.9464|TWO_SIDED|90.0|-24.9|0.26|||Mixed Models Analysis|||||0.26|-24.9|0.9464
91546712|NCT04173663|182973563|SUPERIORITY||Slope|-3.27||||0.092|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the parental empowerment scale.||||||.092
91546713|NCT04173663|182973564|SUPERIORITY||Slope|-1.62||||1.54e-05|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.0000154
91546714|NCT04173663|182973565|SUPERIORITY||Slope|-0.19||||0.014|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.014
91546715|NCT04173663|182973566|SUPERIORITY||Slope|-0.13||||0.883|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||0.883
91546716|NCT04173663|182973567|SUPERIORITY||Slope|-0.11||||0.308|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (6 month post intervention)||||.308
91546717|NCT04173663|182973567|SUPERIORITY||Slope|-0.11||||0.355|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (12 month post intervention)||||.355
91546718|NCT04173663|182973568|SUPERIORITY||Slope|-0.06||||0.699|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services family is receiving (6 month post intervention)||||.699
91546719|NCT04173663|182973568|SUPERIORITY||Slope|-0.1||||0.573|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services the family is receiving (12 month post intervention)||||.573
91546720|NCT04173663|182973568|SUPERIORITY||Slope|-0.23||||0.43|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (6 month post intervention)||||.430
91765522|NCT01369784|183419965|SUPERIORITY_OR_OTHER|||||||0.234|||||||Chi-squared|||||||0.234
91765523|NCT01369784|183419966|SUPERIORITY_OR_OTHER|||||||0.057|||||||Fisher Exact|||||||0.057
91765524|NCT01369784|183419967|SUPERIORITY_OR_OTHER|||||||0.117|||||||Fisher Exact|||||||0.117
91765525|NCT01219985|183419969|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||We performed a McNemar test to compare the sensitivities obtained for each PET image method||||<0.001
91765526|NCT01219985|183419970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis was : lesions' SUVmax are equivalent with our without application of the CT-Based respiratory-gated PET method.||||<0.001
91765527|NCT02905266|183419981|SUPERIORITY||Percent Difference in incidence rates|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Fixed Ratio Combination over Sequential Combination|||0.0|0.0|
91546721|NCT04173663|182973568|SUPERIORITY||Slope|0.27||||0.391|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (12 month post intervention)||||.391
91546722|NCT04173663|182973569|SUPERIORITY||Slope|-0.44||||0.51|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (6 month post intervention)||||.510
91546723|NCT04173663|182973569|SUPERIORITY||Slope|0.64||||0.296|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (12 month post intervention)||||.296
91546724|NCT04173663|182973570|SUPERIORITY||Slope|-0.66||||0.361|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.361
91546725|NCT04173663|182973571|SUPERIORITY||Slope|-0.08||||0.81|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (6 month post intervention)||||.810
91546726|NCT04173663|182973571|SUPERIORITY||Slope|-0.13||||0.678|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (12 month post intervention)||||.678
91546727|NCT04173663|182973572|SUPERIORITY||Slope|0.03||||0.924|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site and cohort,||||||.924
91546728|NCT04833777|182973586|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546729|NCT04833777|182973587|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546730|NCT04833777|182973588|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546731|NCT04833777|182973589|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91765528|NCT02905266|183419989|SUPERIORITY||Percent Difference of ORRs|-7.5|||||TWO_SIDED|95.0|-26.1|11.0|||||Cochran-Mantel-Haenszel (CMH) method of weighting|||11.0|-26.1|
91765529|NCT02905266|183419989|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.35|1.58||||||||1.58|0.35|
91765530|NCT02905266|183419990|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.78|2.37|||||Stratified Cox proportional hazard model|||2.37|0.78|
91546732|NCT04833777|182973590|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546733|NCT04833777|182973591|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546734|NCT04833777|182973592|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546735|NCT04833777|182973593|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91546736|NCT04833777|182973594|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546737|NCT04833777|182973595|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546738|NCT04833777|182973596|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546739|NCT04833777|182973597|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546740|NCT04833777|182973598|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546741|NCT04833777|182973599|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546742|NCT04833777|182973601|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546743|NCT04833777|182973602|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91546744|NCT05418296|182973632|SUPERIORITY||||||<|0.46|||||||t-test, 1 sided|||||||<0.46
91546745|NCT05418296|182973633|SUPERIORITY||||||<|0.00314|||||||t-test, 1 sided|||||||<0.00314
91546746|NCT05418296|182973634|SUPERIORITY||||||<|0.066|||||||t-test, 1 sided|||||||<0.066
91546747|NCT05418296|182973635|SUPERIORITY||||||<|0.085|||||||t-test, 1 sided|||||||<0.0850
91546748|NCT05418296|182973636|SUPERIORITY||||||<|0.0716|||||||t-test, 1 sided|||||||<0.0716
91546749|NCT04419168|182973652|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.57|TWO_SIDED|95.0|-1.3|2.37|||Mixed Models Analysis|||||2.37|-1.30|.57
91546750|NCT04419168|182973653|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|95.0|-0.46|0.61|||Mixed Models Analysis|||||0.61|-0.46|0.79
91546751|NCT04419168|182973654|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.75|TWO_SIDED|95.0|-1.55|1.12|||Mixed Models Analysis|||||1.12|-1.55|0.75
91546752|NCT04419168|182973655|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.31|TWO_SIDED|95.0|-0.6|1.87|||Mixed Models Analysis|||||1.87|-0.60|0.31
91546753|NCT04419168|182973656|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.91|TWO_SIDED|95.0|-1.77|1.99|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||1.99|-1.77|0.91
91546754|NCT04419168|182973656|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.05|TWO_SIDED|95.0|-0.03|3.46|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.46|-0.03|0.05
91546755|NCT04419168|182973657|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.12|TWO_SIDED|95.0|-0.31|2.56|||Mixed Models Analysis|||||2.56|-0.31|0.12
91546756|NCT04419168|182973658|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.91|TWO_SIDED|95.0|-0.0443|0.0395|||Mixed Models Analysis|||||0.0395|-0.0443|0.91
91546757|NCT04419168|182973659|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.68|TWO_SIDED|95.0|-1.61|2.48|||Mixed Models Analysis|||||2.48|-1.61|0.68
91546758|NCT04419168|182973660|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.75|TWO_SIDED|95.0|-0.46|0.63|||Mixed Models Analysis|||||0.63|-0.46|0.75
91765531|NCT02905266|183419991|SUPERIORITY||Cochran-Mantel-Haenszel Odds Ratio|0.87|||||TWO_SIDED|95.0|0.3|2.49|||||Fixed Ratio Combination over Sequential Combination|||2.49|0.30|
91765532|NCT02905266|183419991|SUPERIORITY||Percent difference in incidence rates|-1.9|||||TWO_SIDED|95.0|-16.0|12.2|||||Fixed Ratio Combination over Sequential Combination|||12.2|-16.0|
91546759|NCT04419168|182973661|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.14|TWO_SIDED|95.0|-2.56|0.35|||Mixed Models Analysis|||||0.35|-2.56|0.14
91546760|NCT04419168|182973662|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.75|TWO_SIDED|95.0|-1.69|1.21|||Mixed Models Analysis|||||1.21|-1.69|0.75
91546761|NCT04419168|182973663|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.49|TWO_SIDED|95.0|-1.3|2.71|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||2.71|-1.30|0.49
91546762|NCT04419168|182973663|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.037|TWO_SIDED|95.0|0.12|3.88|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.88|0.12|0.037
91546763|NCT04419168|182973664|SUPERIORITY||Mean Difference (Final Values)|2.13||||0.008|TWO_SIDED|95.0|0.56|3.71|||Mixed Models Analysis|||||3.71|0.56|0.008
91546764|NCT04419168|182973665|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.56|TWO_SIDED|95.0|-1.51|0.82|||Mixed Models Analysis|||||0.82|-1.51|0.56
91546765|NCT04419168|182973666|SUPERIORITY||Mean Difference (Final Values)|-0.0013||||0.95|TWO_SIDED|95.0|-0.0464|0.0437|||Mixed Models Analysis|||||0.0437|-0.0464|0.95
91546766|NCT04419168|182973667|SUPERIORITY||Incidence Rate Ratio|1.11||||0.49|TWO_SIDED|95.0|0.83|1.48|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||1.48|0.83|0.49
91546767|NCT04419168|182973668|SUPERIORITY||Incidence Rate Ratio|1.43||||0.1|TWO_SIDED|95.0|0.93|2.18|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.18|0.93|0.10
91546768|NCT04419168|182973669|SUPERIORITY||Incidence Rate Ratio|1.31||||0.22|TWO_SIDED|95.0|0.85|2.03|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.03|0.85|0.22
91546769|NCT04640961|182973670|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91546770|NCT04640961|182973671|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91546771|NCT04640961|182973672|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91546772|NCT05009251|182973681|SUPERIORITY|||||||0.054|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to Reminder Control patients who were sent messages that did not disclose their risk status. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate vs. messages that do not disclose risk status; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||.054
91546773|NCT05009251|182973681|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to No-Contact Control patients who were not sent messages. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate relative to no messages; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||<.001
91546774|NCT05009251|182973681|SUPERIORITY|||||||0.24|||||||Regression, Linear|||This analysis compared groups who received messages including risk reasons (High Risk Based on Medical Records, High Risk Based on Algorithm) to messages that mentioned patients' risk status but do not include reasons (High Risk Only). Null hypothesis: messages that include risk reasons do not increase flu vaccination rate relative to high-risk messages that do not include risk reasons; Alternative hypothesis: messages including risk reasons are more effective at increasing vaccination rates.||||.240
91546775|NCT05009251|182973681|SUPERIORITY|||||||0.047|||||||Regression, Linear|||Null hypothesis: flu-shot messages that do not mention high-risk status do not increase vaccination relative to no messages; Alternative hypothesis: flu shot messages that do not mention high-risk status increase flu shots relative to no messages.||||.047
91546776|NCT05009251|182973681|SUPERIORITY|||||||0.781||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Medical Records messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Medical Records.||||.781
91546777|NCT05009251|182973681|SUPERIORITY|||||||0.361||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Algorithm.||||.361
91546778|NCT05009251|182973681|SUPERIORITY|||||||0.77||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Based on Medical Records and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Based on Medical Records and High Risk Based on Algorithm.||||.770
91546779|NCT04204278|182973689|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91546780|NCT04204278|182973690|OTHER||||||<|0.0001|||||||t-test, 1 sided|P-Value was calculated||||||<0.0001
91546781|NCT04204278|182973691|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91546782|NCT00676715|182973702|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
91546783|NCT00676715|182973702|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
91546784|NCT00676715|182973702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7496|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||0.7496
91546785|NCT00676715|182973703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0019
91546786|NCT00676715|182973703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0136|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0136
91546787|NCT00676715|182973703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1814|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.1814
91546788|NCT00676715|182973704|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.6||||0.1978|TWO_SIDED|95.0|0.27|1.34|||Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.||||1.34|0.27|0.1978
91546789|NCT00676715|182973704|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.53||||0.131|TWO_SIDED|95.0|0.23|1.22|||CMH chi-square test|CMH chi-square test stratified by geographical region only.||||1.22|0.23|0.1310
91546790|NCT00676715|182973704|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.92||||0.8206|TWO_SIDED|95.0|0.46|1.84|||CMH chi-square tes|CMH chi-square test stratified by geographical region only.||||1.84|0.46|0.8206
91546791|NCT00676715|182973705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1391
91546792|NCT00676715|182973705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1596|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1596
91546793|NCT00676715|182973705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4740
91546794|NCT00676715|182973706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
91546795|NCT00676715|182973706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
91546796|NCT00676715|182973706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4985|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4985
91546797|NCT00676715|182973707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.0004
91546798|NCT00676715|182973707|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
91546799|NCT00676715|182973707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2725|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.2725
91546800|NCT05249439|182973708|OTHER|Paired t-test|Mean Difference (Final Values)|-12.99|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||I-SatPro starting weight Vs 52 week weight (kg)||||<0.0001
91546801|NCT00616967|182973717|SUPERIORITY_OR_OTHER_LEGACY||Pathological complete response rate|0.274|||||TWO_SIDED|95.0|0.169|0.402|||||The Estimation Parameter provided above is for overall pCR for both arms combined. We estimated pCR for each arm separately as well.|Patients were stratified by hormone receptor status and randomly assigned to either arm 1 or 2. This study was designed using Simon's two-stage design for each arm in parallel. Interim analysis of early stopping for futility was conducted for the first 32 patients (16 patients per arm) and the study proceeded as more than 2 patients achieved a pCR in each arm (31 patients per arm). This design had 80% power to detect a 25% pCR rate versus a null rate of 10% with a type I error rate of 0.10.||0.402|0.169|
91546802|NCT00616967|182973717|SUPERIORITY_OR_OTHER_LEGACY||pCR in placebo arm (arm 1)|0.29|||||TWO_SIDED|95.0|0.142|0.48||||||||0.48|0.142|
91546803|NCT00616967|182973717|SUPERIORITY_OR_OTHER_LEGACY||pCR in vorinostat arm (arm 2)|0.258|||||TWO_SIDED|95.0|0.119|0.446||||||||0.446|0.119|
91546804|NCT00616967|182973720|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1||||0.023|TWO_SIDED|95.0|1.3|22.7|||Regression, Logistic|||The estimates provided are based upon a multivariate analysis using a logistic regression adjusting for hormone receptor status. Patients with ≥50% reduction in SULmax were more likely to achieve a pCR.||22.7|1.3|0.023
91546805|NCT05059262|182973730|SUPERIORITY||Difference in ORR|39.0|||<|0.0001|TWO_SIDED|95.0|28.4|49.6||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on Interactive Response Technology (IRT).|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT|||49.6|28.4|<0.0001
91546806|NCT05059262|182973731|SUPERIORITY||Difference in ORR|67.2|||<|0.0001|TWO_SIDED|95.0|57.0|77.3||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||77.3|57.0|<0.0001
91546807|NCT05059262|182973732|SUPERIORITY||LS Mean Difference|14.6||||0.0077|TWO_SIDED|95.0|4.0|25.3||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.|Mixed model repeated measures|||||25.3|4.0|0.0077
91546808|NCT05059262|182973733|SUPERIORITY||LS Mean Difference|3.3||||0.0007|TWO_SIDED|95.0|1.4|5.2||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+PROMIS-PF baseline value.|Mixed model repeated measures|||||5.2|1.4|0.0007
91546809|NCT05059262|182973734|SUPERIORITY||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+Worst Stiffness NRS baseline value.|Mixed model repeated measures|||||-1.1|-2.5|<0.0001
91546810|NCT05059262|182973735|SUPERIORITY||LS Mean Difference|7.4||||0.0155|TWO_SIDED|95.0|1.4|13.4||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.|Mixed model repeated measures|||||13.4|1.4|0.0155
91546811|NCT05059262|182973736|SUPERIORITY||Difference in responder rate|26.2||||0.0056|TWO_SIDED|95.0|9.5|42.8||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||42.8|9.5|0.0056
91546812|NCT03131648|182973753|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|8.6||||0.002|TWO_SIDED|95.0|4.1|13.1||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||13.1|4.1|0.002
91546813|NCT03131648|182973754|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|12.1|||<|0.001|TWO_SIDED|95.0|6.5|17.7||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||17.7|6.5|<0.001
91546814|NCT03131648|182973755|SUPERIORITY||Risk Difference (RD)|9.7||||0.002|TWO_SIDED|95.0|4.4|15.0||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance.||15|4.4|0.002
91546815|NCT03131648|182973756|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-10.4|||<|0.001|TWO_SIDED|95.0|-14.4|-6.5||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or after initiation of rescue medication were not included in the analysis.||-6.5|-14.4|<0.001
91546816|NCT03131648|182973757|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-2.1||||0.002|TWO_SIDED|95.0|-3.4|-0.8||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-0.8|-3.4|0.002
91546817|NCT03131648|182973758|SUPERIORITY||Risk Difference (RD)|6.0||||0.68|TWO_SIDED|95.0|-21.8|33.7||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant."|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated.|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||33.7|-21.8|0.68
91546818|NCT03131648|182973758|SUPERIORITY||Risk Difference (RD)|-9.5||||0.5|TWO_SIDED|95.0|-37.1|18.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||18.0|-37.1|0.50
91546819|NCT03131648|182973759|SUPERIORITY||Risk Difference (RD)|21.2||||0.056|TWO_SIDED|95.0|-0.2|42.6||Test not evaluated for significance. Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||42.6|-0.2|0.056
91546820|NCT03131648|182973759|SUPERIORITY||Risk Difference (RD)|11.7||||0.27|TWO_SIDED|95.0|-8.7|32.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||32.0|-8.7|0.27
91546821|NCT03131648|182973762|SUPERIORITY|"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.3|26.8|||Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||26.8|13.3|<0.001
91546822|NCT03131648|182973763|SUPERIORITY||Risk Difference (RD)|10.3|||<|0.001|TWO_SIDED|95.0|6.4|14.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||14.1|6.4|<0.001
91546823|NCT03131648|182973764|SUPERIORITY||Difference of least square means|-6.4|||<|0.001|TWO_SIDED|95.0|-8.8|-4.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-4.1|-8.8|<0.001
91546824|NCT03131648|182973765|SUPERIORITY||Risk Difference (RD)|5.7||||0.007|TWO_SIDED|95.0|2.5|8.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered nonresponders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||8.9|2.5|0.007
91546825|NCT03131648|182973766|SUPERIORITY||Risk Difference (RD)|14.1|||<|0.001|TWO_SIDED|95.0|8.6|19.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||19.6|8.6|<0.001
91546826|NCT03131648|182973767|SUPERIORITY||Difference of least square means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.4|-1.4|<0.001
91546827|NCT03131648|182973768|SUPERIORITY||Risk Difference (RD)|15.2|||<|0.001|TWO_SIDED|95.0|9.2|21.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||21.3|9.2|<0.001
91546828|NCT03131648|182973769|SUPERIORITY||Risk Difference (RD)|13.0||||0.001|TWO_SIDED|95.0|5.4|20.5||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||20.5|5.4|0.001
91546829|NCT02724878|182973770|SUPERIORITY||Response Rate|33.0|||||TWO_SIDED|80.0|25.0|42.0||||||A sample size of 60 would provide 95% power to distinguish the ORR rate of 25% from 10% (historical control) with 1-sided alpha of 0.07. The treatment would be considered effective if 10 or more responses are observed out of 60 patients.||42|25|
91546830|NCT03661840|182973793|SUPERIORITY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|17.0||0.82|TWO_SIDED|95.0|-31.0|39.0||Unadjusted model comparing the mean difference (change from 12 weeks - baseline) in outcome by intervention group.|Regression, Linear|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||39|-31|0.82
91546831|NCT03661840|182973794|SUPERIORITY||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|6.4||0.06|TWO_SIDED|95.0|-0.7|25.0||Unadjusted model comparing the change in outcome by intervention group|Regression, Linear|||||25|-0.7|0.06
91546832|NCT03661840|182973794|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||ANOVA|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||||0.05
91546833|NCT05873751|182973838|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
91546834|NCT05873751|182973839|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
91546835|NCT05873751|182973840|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
91546836|NCT05873751|182973841|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
91546837|NCT01772472|182973842|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
91546838|NCT01772472|182973843|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
91546839|NCT01772472|182973844|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<.0001
91546840|NCT01772472|182973845|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
91546841|NCT01772472|182973846|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<0.0001
91546842|NCT01772472|182973847|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
91546843|NCT01772472|182973848|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
91546844|NCT01772472|182973849|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
91765533|NCT00596752|183419996|SUPERIORITY_OR_OTHER|||||||0.2587||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.2587
91765534|NCT00596752|183419996|SUPERIORITY_OR_OTHER|||||||0.3463||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.3463
91765535|NCT00596752|183419997|SUPERIORITY_OR_OTHER|||||||0.0173||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.0173
91765536|NCT00596752|183419997|SUPERIORITY_OR_OTHER|||||||0.1154||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.1154
91765537|NCT02538042|183420014|SUPERIORITY|||||||0.39|||||||ANOVA|||||||0.39
91765538|NCT04445662|183420020|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
91546845|NCT01772472|182973850|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<.0001
91546846|NCT01772472|182973851|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
91546847|NCT01772472|182973852|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082||95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
91765539|NCT04445662|183420021|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
91765540|NCT02915978|183420054|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.0505|TWO_SIDED|95.0|-3.61|0.0|||ANCOVA|||NRS PID at 1 hour||0.00|-3.61|0.0505
91765541|NCT02915978|183420054|OTHER||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.9||0.2493|TWO_SIDED|95.0|-2.89|0.77|||ANCOVA|||NRS PID at 1 hour||0.77|-2.89|0.2493
91765542|NCT02915978|183420054|OTHER||LS Mean Difference|-2.94|STANDARD_ERROR_OF_MEAN|0.99||0.0052|TWO_SIDED|95.0|-4.95|-0.94|||ANCOVA|||NRS PID at 16 hours||-0.94|-4.95|0.0052
91546848|NCT01772472|182973853|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
91546849|NCT01772472|182973854|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
91546850|NCT01772472|182973855|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
91546851|NCT01772472|182973856|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<.0001
91546852|NCT02697136|182973871|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study. Using an assumed standard deviation of 4.5% and a 2:1 randomization scheme to maximize exposure to active drug, 16 completing patients in the CER-001 group and 8 in the placebo group (24 total completers for mITT) would yield 90% power to detect a difference from baseline versus placebo of 6.7%, using two-tailed testing with α=0.05.|Difference in LS Means|-0.08||||0.185|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||||0.4|-1.9|0.185
91546853|NCT02697136|182973872|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||||1.8|-0.4|0.217
91546854|NCT02697136|182973873|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|-0.2||||0.832|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||||1.3|-1.6|0.832
91546855|NCT04391894|182973876|SUPERIORITY||Least Squares Mean (LS Mean)|-1.1|STANDARD_ERROR_OF_MEAN|2.01||0.585|TWO_SIDED|95.0|-5.0|2.8|||Mixed Models Analysis|||||2.8|-5.0|0.585
91765543|NCT02915978|183420054|OTHER||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.97||0.0926|TWO_SIDED|95.0|-3.62|0.29|||ANCOVA|||NRS PID at 16 hours||0.29|-3.62|0.0926
91765544|NCT02915978|183420054|OTHER||LS Means Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.0951|TWO_SIDED|95.0|-3.06|0.26|||ANCOVA|||NRS PID at 24 hours||0.26|-3.06|0.0951
91765545|NCT02915978|183420054|OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.8||0.9866|TWO_SIDED|95.0|-1.6|1.63|||ANCOVA|||NRS PID at 24 hours||1.63|-1.60|0.9866
91546856|NCT04391894|182973876|SUPERIORITY||Least Squares Mean (LS Mean)|-3.2|STANDARD_ERROR_OF_MEAN|2.0||0.107|TWO_SIDED|95.0|-7.01|0.7|||Mixed Models Analysis|||||0.7|-7.01|0.107
91546857|NCT04391894|182973876|SUPERIORITY||Least Squares Mean (LS Mean)|4.3|STANDARD_ERROR_OF_MEAN|2.02||0.033|TWO_SIDED|95.0|0.3|8.3|||Mixed Models Analysis|||||8.3|0.3|0.033
91546858|NCT04391894|182973877|SUPERIORITY||Least Squares Mean (LS Mean)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.605|TWO_SIDED|95.0|-0.8|0.4|||Mixed Models Analysis|||||0.4|-0.8|0.605
91546859|NCT04391894|182973877|SUPERIORITY||Least Squares Mean (LS Mean)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.646|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.646
91546860|NCT04391894|182973877|SUPERIORITY||Least Squares Mean (LS Mean)|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.847|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.847
91546861|NCT04391894|182973878|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
91546862|NCT04391894|182973878|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
91546863|NCT04391894|182973878|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
91546864|NCT04391894|182973879|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
91546865|NCT04391894|182973879|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
91546866|NCT04391894|182973879|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.1|0.6||||||||0.6|0.1|
91546867|NCT01889199|182973881|OTHER||Mean Difference (Final Values)|1.12||||0.004|TWO_SIDED|||||a priori threshold p\<0.05|t-test, 2 sided|||Only PCOS women were randomized to flutamide versus placebo; controls were not randomized A sample size of 11 per group (PCOS women versus controls) provided adequate power (approximately 80%) to detect effect sizes as small as 1.25 using a two-sample t-test (alpha=0.05, 2 tailed). A sample size of 5 per group (flutamide-treated versus placebo-treated PCOS women) also gave adequate power (approximately 80%) to detect effect sizes as small as 2 using a two-sample t-test (alpha=0.05, 2 tailed).||||0.004
91546868|NCT01889199|182973882|OTHER||Mean Difference (Net)|0.024|||||TWO_SIDED|||||||||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||
91546869|NCT01889199|182973884|OTHER||Mean Difference (Net)|0.04||||0.04|TWO_SIDED||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.040
91546870|NCT01889199|182973885|OTHER|||||||0.034|||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.034
91546871|NCT02323321|182973888|OTHER|The primary hypothesis for this study is that the true (success) proportion of transplanted patients meeting the primary effectiveness endpoint, patient survival at day 30 post-transplantation and absence of severe PGD (left or right ventricle) in the first 24 hours post-transplantation, is greater than the Performance Goal value of 0.65.|Proportion|88.0|||<|0.0001|TWO_SIDED|95.0|78.4|94.4|||one-sided exact binomial test|||||94.4|78.4|<0.0001
91546872|NCT00446225|182973889|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0001|TWO_SIDED|95.0|0.27|0.64|||Log Rank|||||0.64|0.27|0.0001
91546873|NCT00446225|182973891|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.043|TWO_SIDED|95.0|0.36|0.99|||Log Rank|||||0.99|0.36|0.043
91546874|NCT00220740|182973909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.||||<0.001
91546875|NCT00220740|182973910|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||ANCOVA|||||||0.542
91546876|NCT00220740|182973911|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Dominant hand||||<0.001
91546877|NCT00220740|182973911|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Non-dominant hand||||0.005
91546878|NCT02662062|182973950|OTHER|This is a single arm study looking at a binary value with the hypothesis suggesting it falls within a certain range.||||||||||||||||The null hypothesis is that the addition of pembrolizumab to chemoradiation is not unsafe (percentage of the population experiencing unacceptable toxicity is not \>50%)|A Clopper-Pearson method was used to determine the unacceptable toxicity rate and a 95% confidence interval for this binary outcome measure.|||
91546879|NCT02662062|182973951|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
91546880|NCT02662062|182973952|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
91546881|NCT02662062|182973953|OTHER|Non comparative trial with a single arm|Kaplan Meier Estimate|39.0|||||TWO_SIDED|95.0|17.0||missing upper limit of 95% confidence interval on the survival estimate from Kaplan-Meier estimator due to small number events||||||||17|
91546882|NCT02662062|182973954|OTHER|Kaplan Meier Estimate performed for a 12 month timepoint in a single arm non comparative study|Kaplan Meier Estimate|92.0|||||TWO_SIDED|95.0|72.0|98.0||||||||98|72|
91546883|NCT02662062|182973955|OTHER|Kaplan Meier Estimate of single arm non comparative study|Kaplan Meier Estimate|85.0|||||TWO_SIDED|95.0|64.0|94.0||||||||94|64|
91546884|NCT02662062|182973956|OTHER|Kaplan Meier estimate at a 12 month timepoint for a single arm non comparative study|Kaplan Meier Estimate|88.0|||||TWO_SIDED|95.0|68.0|98.0||||||||98|68|
91546885|NCT02910583|182973965|SUPERIORITY||Difference in Rates|4.7||||0.1475|TWO_SIDED|95.0|-1.6|10.9||P-value is from Z test for the difference of two proportions based on Kaplan-Meier estimates with standard error of each arm computed using Greenwood's formula.|Z test||comparison: ibrutininb vs. placebo|||10.9|-1.6|0.1475
91546886|NCT02910583|182973966|SUPERIORITY||||||<|0.0001||||||One-sided P-value from asymptotic test for the binomial proportion (CRR \<= 37% vs CRR \> 37%).|asymptotic test for binomial proportion|||||||< 0.0001
91546887|NCT03779204|182974028|OTHER||Mean Difference (Final Values)|-2.0||||0.18|TWO_SIDED|95.0|-5.0|1.0|||ANCOVA|||||1.0|-5.0|0.18
91546888|NCT03779204|182974029|OTHER||Mean Difference (Final Values)|-1.4||||0.44|TWO_SIDED|95.0|-5.0|2.3|||ANCOVA|||||2.3|-5.0|0.44
91546889|NCT03779204|182974030|OTHER||Mean Difference (Final Values)|7.3||||0.38|TWO_SIDED|95.0|-9.7|24.4|||ANCOVA|||||24.4|-9.7|.38
91546890|NCT03779204|182974031|OTHER||Mean Difference (Final Values)|0.6||||0.76|TWO_SIDED|95.0|-3.3|4.4|||ANCOVA|||||4.4|-3.3|0.76
91546891|NCT03779204|182974032|OTHER|||||||0.68|||||||ANCOVA|||||||0.68
91546892|NCT03779204|182974033|OTHER||Mean Difference (Final Values)|-7.2||||0.12|TWO_SIDED|95.0|-16.4|2.0|||ANCOVA|||||2.0|-16.4|0.12
91546893|NCT03779204|182974034|OTHER||Mean Difference (Final Values)|-4.4||||0.34|TWO_SIDED|95.0|-13.7|5.0|||ANCOVA|||||5.0|-13.7|0.34
91546894|NCT03779204|182974036|OTHER||Mean Difference (Final Values)|-1.3||||0.62|TWO_SIDED|95.0|-6.6|4.0|||ANCOVA|||||4.0|-6.6|0.62
91765546|NCT00892775|183420074|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% confidence interval around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.64|||||TWO_SIDED|95.0|-2.29|1.76||||||||1.76|-2.29|
91765547|NCT00892775|183420074|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.74|||||TWO_SIDED|95.0|-6.14|5.58||||||||5.58|-6.14|
91765548|NCT00892775|183420074|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.32|||||TWO_SIDED|95.0|-1.78|2.08||||||||2.08|-1.78|
91546895|NCT05493787|182974069|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Active Control message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Active Control message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
91546896|NCT05493787|182974069|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Ease message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Ease message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
91546897|NCT05493787|182974069|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Waiting for You message message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Waiting for You message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
91546898|NCT05493787|182974069|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Rare message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Rare Message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
91546899|NCT05493787|182974069|SUPERIORITY|||||||0.035||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Frequent message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Frequent message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.035
91546900|NCT05493787|182974069|SUPERIORITY|||||||0.593||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Ease messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Ease messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.593
91546901|NCT05493787|182974069|SUPERIORITY|||||||0.052||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Waiting for You messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.052
91546902|NCT05493787|182974069|SUPERIORITY|||||||0.952||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Rare messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.952
91546903|NCT05493787|182974069|SUPERIORITY|||||||0.386||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Frequent messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.386
91546904|NCT05493787|182974069|SUPERIORITY|||||||0.498||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Waiting for You messages. Analysis combines across November and December send dates.||||.498
91546905|NCT05493787|182974069|SUPERIORITY|||||||0.935||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Rare messages. Analysis combines across November and December send dates.||||.935
91546906|NCT05493787|182974069|SUPERIORITY|||||||0.504||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Frequent message messages. Analysis combines across November and December send dates.||||.504
91546907|NCT05493787|182974069|SUPERIORITY|||||||0.19||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Waiting for You messages. Analysis combines across November and December send dates.||||.190
91546908|NCT05493787|182974069|SUPERIORITY|||||||0.027||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Frequent messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Frequent and Waiting for You messages. Analysis combines across November and December send dates.||||.027
91546909|NCT05493787|182974069|SUPERIORITY|||||||0.854||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Protect Yourself - Frequent messages. Analysis combines across November and December send dates.||||.854
91546910|NCT05493787|182974069|SUPERIORITY|||||||0.637||||||The reported p-value (2-tailed) is for the interaction term between message send date (November, December) and message (any message arm no message)|Regression, Linear|||"Null Hypothesis: Messages sent in November and December are equally effective at promoting flu-shot self-scheduling. Alternative hypothesis: Messages sent in November and December are differentially effective.~To test the alternative hypothesis, all message arms (Active control, Ease, Waiting for you, Protect yourself - rare, Protect yourself - frequent) were combined and compared with Passive control."||||.637
91546911|NCT02384317|182974100|SUPERIORITY||Slope|-2.4|STANDARD_DEVIATION|141.77||0.965|TWO_SIDED|95.0|-133.6|128.7|||Random coefficients regression|||||128.7|-133.6|0.965
91546912|NCT03526861|182974127|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|13.8||||0.002|TWO_SIDED|95.0|5.3|22.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.3|5.3|0.002
91546913|NCT03526861|182974127|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|8.4|26.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||26.6|8.4|<0.001
91765549|NCT00892775|183420074|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|4.69|||||TWO_SIDED|95.0|0.72|10.34||||||||10.34|0.72|
91765550|NCT01973413|183420098|NON_INFERIORITY_OR_EQUIVALENCE|Significance level of 0.05, 90% power, required 48 nights of OCL and 48 control nights to detect a 20% improvement.|||||=|0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.037
91765551|NCT01973413|183420099|SUPERIORITY_OR_OTHER||||||=|0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.340
91546914|NCT03526861|182974128|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|12.0|32.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.0|12.0|<0.001
91546915|NCT03526861|182974128|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|12.4|32.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.6|12.4|<0.001
91546916|NCT03526861|182974129|SUPERIORITY|Secondary endpoint tested sequentially at a 2.5% significance level|Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.3|31.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.1|12.3|<0.001
91546917|NCT03526861|182974129|SUPERIORITY|Secondary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|19.9|||<|0.001|TWO_SIDED|95.0|10.6|29.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||29.2|10.6|<0.001
91546918|NCT03526861|182974130|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-19.7|||<|0.001|TWO_SIDED|95.0|-27.1|-12.2||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-12.2|-27.1|<0.001
91546919|NCT03526861|182974130|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-18.0|||<|0.001|TWO_SIDED|95.0|-25.6|-10.4||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-10.4|-25.6|<0.001
91546920|NCT03526861|182974131|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.6||||0.007|TWO_SIDED|95.0|-4.5|-0.7||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.7|-4.5|0.007
91546921|NCT03526861|182974131|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.0||||0.04|TWO_SIDED|95.0|-3.9|-0.1||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.1|-3.9|0.040
91765552|NCT03691571|183420116|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||Esophageal thermal injury was detected in 13/44 (30%) patients.||||>.05
91765553|NCT03691571|183420118|OTHER|feasibility/pilot study||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91765554|NCT03691571|183420119|OTHER|feasibility/pilot study||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91765555|NCT03691571|183420120|OTHER|feasibility/pilot study||||||0.1|||||||Fisher Exact|||||||0.10
91546922|NCT03526861|182974134|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|38.5|||<|0.001|TWO_SIDED|95.0|26.8|50.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||50.2|26.8|<0.001
91546923|NCT03526861|182974134|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|32.4|||<|0.001|TWO_SIDED|95.0|20.6|44.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||44.1|20.6|<0.001
91546924|NCT03526861|182974135|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|13.7||||0.002|TWO_SIDED|95.0|5.2|22.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.2|5.2|0.002
91546925|NCT03526861|182974135|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.3|||<|0.001|TWO_SIDED|95.0|6.5|24.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||24.1|6.5|<0.001
91546926|NCT03526861|182974136|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.5|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.5|<0.001
91546927|NCT03526861|182974136|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.6|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.6|<0.001
91546928|NCT03526861|182974137|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|11.5||||0.002|TWO_SIDED|95.0|4.5|18.4||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||18.4|4.5|0.002
91546929|NCT03526861|182974137|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|7.8|23.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||23.3|7.8|<0.001
91546930|NCT03526861|182974138|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|26.2|||<|0.001|TWO_SIDED|95.0|16.1|36.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||36.3|16.1|<0.001
91546931|NCT03526861|182974138|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|25.5|||<|0.001|TWO_SIDED|95.0|15.3|35.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||35.7|15.3|<0.001
91546932|NCT03526861|182974139|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.5|||<|0.001|TWO_SIDED|95.0|-2.4|-0.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.6|-2.4|<0.001
91546933|NCT03526861|182974139|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.2||||0.007|TWO_SIDED|95.0|-2.1|-0.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.3|-2.1|0.007
91546934|NCT03526861|182974140|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.7|31.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.0|9.7|<0.001
91546935|NCT03526861|182974140|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|21.8|||<|0.001|TWO_SIDED|95.0|10.9|32.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.7|10.9|<0.001
91546936|NCT03526861|182974141|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.6|-8.4|<0.001
91546937|NCT03526861|182974141|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-5.4|||<|0.001|TWO_SIDED|95.0|-7.9|-3.0||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.0|-7.9|<0.001
91546938|NCT03940963|182974205|NON_INFERIORITY|The visual analog scale (VAS, 0-100 scale) pain score change from baseline value to 12 months was tested for non-inferiority of neurectomy with Axoguard Nerve Cap to standard neurectomy alone using closed testing procedures.||||||0.011||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.011
91546939|NCT03940963|182974208|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.485||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.485
91546940|NCT03940963|182974209|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.259||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.259
91546941|NCT03940963|182974210|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.14||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.140
91546942|NCT03940963|182974211|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.544||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.544
91546943|NCT03940963|182974213|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.049||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.049
91546944|NCT03336333|182974274|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.63||One-sided|Log Rank|||||0.63|0.28|<0.0001
91546945|NCT04401800|182974297|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||||||0.0002
91546946|NCT04401800|182974299|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||||||< 0.0001
91546947|NCT04401800|182974300|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
91546948|NCT04401800|182974300|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||< 0.0001
91546949|NCT04401800|182974301|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
91546950|NCT04401800|182974301|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||0.0002
91546951|NCT04927065|182974320|OTHER||Geometric Mean Ratio (GMR)|2.5|||||TWO_SIDED|95.0|2.0|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAB: Part A.2 versus Part A.1|||3.0|2.0|
91546952|NCT04927065|182974320|OTHER||GMR|2.0|||||TWO_SIDED|95.0|1.7|2.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||2.3|1.7|
91546953|NCT04927065|182974321|OTHER||Geometric Mean Ratio (GMR)|6.3|||||TWO_SIDED|95.0|4.5|8.9|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||8.9|4.5|
91546954|NCT04927065|182974321|OTHER||GMR|2.8|||||TWO_SIDED|95.0|2.1|3.6|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||3.6|2.1|
91546955|NCT04927065|182974322|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.1|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||5.6|-3.1|
91546956|NCT04927065|182974322|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
91546957|NCT04927065|182974323|OTHER||Percentage Difference|-1.3|||||TWO_SIDED|95.0|-6.9|4.3|||||Omicron variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||4.3|-6.9|
91546958|NCT04927065|182974323|OTHER||Percentage Difference|-2.6|||||TWO_SIDED|95.0|-9.6|4.5|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||4.5|-9.6|
91546959|NCT04927065|182974324|OTHER||Percentage Difference|12.9|||||TWO_SIDED|95.0|4.1|21.6|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||21.6|4.1|
91546960|NCT04927065|182974324|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
91546961|NCT04927065|182974325|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-11.4|17.1|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||17.1|-11.4|
91546962|NCT04927065|182974325|OTHER||Percentage Difference|-7.1|||||TWO_SIDED|95.0|-21.6|7.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||7.3|-21.6|
91546963|NCT04927065|182974326|OTHER||GMR|1.777|||||TWO_SIDED|95.0|1.523|2.073|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.073|1.523|
91546964|NCT04927065|182974327|OTHER||Percentage Difference|0.6|||||TWO_SIDED|95.0|-1.7|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||3.0|-1.7|
91546965|NCT04927065|182974328|OTHER||Percentage Difference|17.9|||||TWO_SIDED|95.0|9.8|26.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||26.0|9.8|
91546966|NCT04927065|182974329|OTHER||GMR|1.744|||||TWO_SIDED|97.5|1.492|2.04|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.040|1.492|
91546967|NCT04927065|182974329|OTHER||GMR|1.211|||||TWO_SIDED|97.5|1.074|1.366|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.366|1.074|
91546968|NCT04927065|182974330|OTHER||GMR|1.676|||||TWO_SIDED|97.5|1.396|2.013|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.013|1.396|
91546969|NCT04927065|182974330|OTHER||GMR|1.105|||||TWO_SIDED|97.5|0.97|1.26|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.260|0.970|
91546970|NCT04927065|182974331|OTHER||Percentage Difference|1.5|||||TWO_SIDED|97.5|-1.1|4.1|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||4.1|-1.1|
91546971|NCT04927065|182974332|OTHER||Percentage Difference|21.5|||||TWO_SIDED|97.5|12.8|30.2|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||30.2|12.8|
91546972|NCT04927065|182974333|OTHER||Percentage Difference|1.8|||||TWO_SIDED|97.5|-1.9|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||5.6|-1.9|
91546973|NCT04927065|182974334|OTHER||Percentage Difference|20.6|||||TWO_SIDED|97.5|12.4|28.7|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||28.7|12.4|
91546974|NCT04927065|182974335|OTHER||GMR|6.412|||||TWO_SIDED|95.0|5.369|7.658|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||7.658|5.369|
91546975|NCT04927065|182974335|OTHER||GMR|1.967|||||TWO_SIDED|95.0|1.708|2.265|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.265|1.708|
91546976|NCT04927065|182974336|OTHER||Percentage Difference|12.2|||||TWO_SIDED|95.0|6.9|17.4|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||17.4|6.9|
91546977|NCT04927065|182974336|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||||
91546978|NCT04927065|182974337|OTHER||Percentage Difference|54.7|||||TWO_SIDED|95.0|47.5|61.8|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||61.8|47.5|
91546979|NCT04927065|182974337|OTHER||Percentage Difference|37.6|||||TWO_SIDED|95.0|29.3|45.9|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||45.9|29.3|
91546980|NCT04927065|182974346|OTHER||GMR|0.836|||||TWO_SIDED|95.0|0.745|0.938|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||0.938|0.745|
91546981|NCT04927065|182974347|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg 95% CI could not be calculated due to the SRR difference is 0.|||||
91546982|NCT04927065|182974348|OTHER||SRR Difference|-13.1|||||TWO_SIDED|95.0|-21.2|-5.0|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||-5.0|-21.2|
91546983|NCT04927065|182974349|OTHER||SRR Difference|0.0|||||TWO_SIDED|97.5|||||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273 95% CI could not be calculated due to the SRR difference is 0.|||||
91546984|NCT04927065|182974349|OTHER||SRR Difference|0.9|||||TWO_SIDED|97.5|-1.6|3.5|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||3.5|-1.6|
91546985|NCT04927065|182974349|OTHER||SRR Difference|-0.1|||||TWO_SIDED|95.0|-2.3|2.1|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.1|-2.3|
91546986|NCT04927065|182974349|OTHER||SRR Difference|-1.9|||||TWO_SIDED|95.0|-5.3|1.5|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.5|-5.3|
91546987|NCT04927065|182974350|OTHER||SRR Difference|10.9|||||TWO_SIDED|97.5|1.7|20.1|||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273|||20.1|1.7|
91546988|NCT04927065|182974350|OTHER||SRR Difference|9.2|||||TWO_SIDED|97.5|1.4|17.0|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||17.0|1.4|
91546989|NCT04927065|182974350|OTHER||SRR Difference|10.1|||||TWO_SIDED|95.0|3.0|17.2|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||17.2|3.0|
91546990|NCT04927065|182974350|OTHER||SRR Difference|4.3|||||TWO_SIDED|95.0|-5.0|13.6|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||13.6|-5.0|
91546991|NCT04927065|182974352|OTHER||GMR|1.818|||||TWO_SIDED|95.0|1.469|2.249|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.249|1.469|
91546992|NCT04927065|182974354|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|-2.6|2.5|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.5|-2.6|
91546993|NCT04927065|182974356|OTHER||SRR Difference|25.5|||||TWO_SIDED|95.0|16.9|34.1|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||34.1|16.9|
91546994|NCT04927065|182974357|OTHER||SRR Difference|5.0|||||TWO_SIDED|95.0|0.3|9.8|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||9.8|0.3|
91546995|NCT04927065|182974357|OTHER||SRR Difference|5.6|||||TWO_SIDED|95.0|-0.3|11.5|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||11.5|-0.3|
91546996|NCT04927065|182974358|OTHER||SRR Difference|14.5|||||TWO_SIDED|95.0|6.7|22.3|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||22.3|6.7|
91546997|NCT04927065|182974358|OTHER||SRR Difference|8.0|||||TWO_SIDED|95.0|-2.1|18.0|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||18.0|-2.1|
91546998|NCT04927065|182974359|OTHER||GMR|1.637|||||TWO_SIDED|95.0|1.243|2.155|||||SARS-CoV-2 (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.155|1.243|
91546999|NCT04927065|182974359|OTHER||GMR|1.373|||||TWO_SIDED|95.0|0.953|1.976|||||SARS-CoV-2 (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.976|0.953|
91547000|NCT04927065|182974359|OTHER||GMR|1.271|||||TWO_SIDED|95.0|1.051|1.537|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||1.537|1.051|
91547001|NCT04927065|182974359|OTHER||GMR|1.101|||||TWO_SIDED|95.0|0.83|1.461|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.461|0.830|
91547002|NCT05671029|182974367|NON_INFERIORITY|Null hypothesis: difference to placebo of change from baseline QTcF ≥ 10 ms.|Prediction @ mean max concentration|0.8|||<|0.05|TWO_SIDED|90.0|-1.3|2.9|||Mixed Models Analysis|||||2.9|-1.3|<0.05
91547003|NCT05767437|182974384|EQUIVALENCE|effect size of 0.02, α \< 0.05, power = 0.02|Mean Difference (Net)|1.63||||0.98|TWO_SIDED|95.0|-55.79|59.05|||Mixed Models Analysis|||||59.05|-55.79|0.98
91547004|NCT05767437|182974385|EQUIVALENCE|an effect size of 0.00, α \< 0.05, power = 0.00|Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.25|1.24|||Mixed Models Analysis|||||1.24|-1.25|0.99
91547005|NCT05767437|182974386|EQUIVALENCE|an effect size of 0.56 , α \< 0.05, power = 32.5|Mean Difference (Net)|6.71||||0.68|TWO_SIDED|95.0|-24.12|10.71|||Mixed Models Analysis|||||10.71|-24.12|0.68
91547006|NCT05767437|182974387|EQUIVALENCE|Analysis population description: patients were randomly assigned to either Group A or Group B|Mean Difference (Net)|0.2||||0.56|TWO_SIDED|95.0|-0.48|0.87|||Mixed Models Analysis|||an effect size of 0.24, α \< 0.05, power = 24.5||0.87|-0.48|0.56
91547007|NCT05767437|182974388|EQUIVALENCE|an effect size of 0.56, α \< 0.05, power = 57.9|Mean Difference (Net)|-250.35||||0.42|TWO_SIDED|95.0|-614.88|114.18||Interaction of Assessment and Group|Mixed Models Analysis|||||114.18|-614.88|0.42
91547008|NCT05767437|182974389|EQUIVALENCE|an effect size of 0.29, α \< 0.05, power = 88.9|Mean Difference (Net)|12.25||||0.45|TWO_SIDED|95.0|-18.67|43.17|||Mixed Models Analysis|||||43.17|-18.67|0.45
91547009|NCT05767437|182974390|EQUIVALENCE|an effect size of 0.18, α \< 0.05, power =6.5|mean rank (Z)|0.18||||0.67|TWO_SIDED|95.0|-0.61|0.96||MAS of Biceps|Wilcoxon (Mann-Whitney)|||||0.96|-0.61|0.67
91547010|NCT05767437|182974391|EQUIVALENCE|an effect size of 0.39, α \< 0.05, power = 16.2|Mean Difference (Net)|-6.63||||0.38|TWO_SIDED|95.0|-19.38|6.12|||t-test, 2 sided|||||6.12|-19.38|0.38
91547011|NCT05592418|182974420|SUPERIORITY||Mean Difference (Final Values)|0.0288||||0.9851|TWO_SIDED|95.0|-3.0397|3.0972|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.0972|-3.0397|0.9851
91547012|NCT05592418|182974421|SUPERIORITY||Mean Difference (Final Values)|-1.9076||||0.3095|TWO_SIDED|95.0|-5.6279|1.8128|||ANCOVA|||||1.8128|-5.6279|0.3095
91547013|NCT05592418|182974422|SUPERIORITY||Mean Difference (Final Values)|0.6086||||0.7663|TWO_SIDED|95.0|-3.4656|4.6829|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.6829|-3.4656|0.7663
91547014|NCT05592418|182974423|SUPERIORITY||Mean Difference (Final Values)|23.7749||||0.3162|TWO_SIDED|95.0|-23.2463|70.7962|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||70.7962|-23.2463|0.3162
91547015|NCT05592418|182974424|SUPERIORITY|||||||||||||||||P-value is from The Cochran-Mantel-Haenszel test (CMH) stratified by stratification factors|Since all patients analyzed achieved MCID, there are no comparison results|||
91547016|NCT05592418|182974425|SUPERIORITY||Mean Difference (Final Values)|-3.2342||||0.4232|TWO_SIDED|95.0|-11.2586|4.7901|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.7901|-11.2586|0.4232
91547017|NCT05592418|182974426|SUPERIORITY||Mean Difference (Final Values)|-0.5161||||0.7823|TWO_SIDED|95.0|-4.2356|3.2035|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.2035|-4.2356|0.7823
91547018|NCT05592418|182974428|SUPERIORITY||Mean Difference (Final Values)|0.2779||||0.5185|TWO_SIDED|95.0|-0.5775|1.1333|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|||1.1333|-0.5775|0.5185
91547019|NCT05592418|182974429|OTHER||||||||||||||||||No patients were hospitalized.|||
91547020|NCT05592418|182974431|SUPERIORITY||Mean Difference (Final Values)|169.389||||0.2175|TWO_SIDED|95.0|-105.892|444.6702|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|444.6702|-105.892|0.2175
91547021|NCT05592418|182974432|SUPERIORITY||Mean Difference (Final Values)|-56.9984||||0.2086|TWO_SIDED|95.0|-147.021|33.0241|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|33.0241|-147.021|0.2086
91547022|NCT05592418|182974433|SUPERIORITY||Mean Difference (Final Values)|0.1733||||0.0975|TWO_SIDED|95.0|-0.0327|0.3792|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|0.3792|-0.0327|0.0975
91547023|NCT05592418|182974435|SUPERIORITY||Mean Difference (Final Values)|20.7131||||0.4545|TWO_SIDED|95.0|-34.4079|75.8341|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||75.8341|-34.4079|0.4545
91547024|NCT05592418|182974436|SUPERIORITY||Mean Difference (Final Values)|44.1231||||0.0333|TWO_SIDED|95.0|4.6338|83.6123|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||83.6123|4.6338|0.0333
91547025|NCT05198310|182974514|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.281||0.047|TWO_SIDED|95.0|-1.13|-0.01||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||-0.01|-1.13|0.0470
91547026|NCT05198310|182974514|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.282||0.2124|TWO_SIDED|95.0|-0.92|0.21||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.21|-0.92|0.2124
91547027|NCT05198310|182974514|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.352||0.1091|TWO_SIDED|95.0|-1.28|0.13||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.13|-1.28|0.1091
91547028|NCT05198310|182974515|SUPERIORITY|||||||0.0312|||||||t-test|||||||0.0312
91547029|NCT05198310|182974515|SUPERIORITY|||||||0.0338|||||||t-test|||||||0.0338
91547030|NCT05198310|182974519|SUPERIORITY|||||||0.0333|||||||Fisher exact test|||||||0.0333
91547031|NCT05198310|182974519|SUPERIORITY|||||||0.1905|||||||Fisher exact test|||||||0.1905
91547032|NCT05198310|182974519|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0716|TWO_SIDED|95.0|0.9|9.65|||Cochran-Mantel-Haenszel|||||9.65|0.90|0.0716
91547033|NCT05198310|182974519|SUPERIORITY||Odds Ratio (OR)|1.52||||0.471|TWO_SIDED|95.0|0.5|4.67|||Cochran-Mantel-Haenszel|||||4.67|0.50|0.4710
91547034|NCT05198310|182974519|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0057|TWO_SIDED|95.0|1.62|22.88|||Cochran-Mantel-Haenszel|||||22.88|1.62|0.0057
91547035|NCT05198310|182974520|SUPERIORITY|||||||0.0762|||||||Fisher exact test|||||||0.0762
91547036|NCT05198310|182974520|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.000
91547037|NCT05198310|182974520|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4172|TWO_SIDED|95.0|0.49|5.62|||Cochran-Mantel-Haenszel|||||5.62|0.49|0.4172
91547038|NCT05198310|182974520|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3144|TWO_SIDED|95.0|0.55|6.45|||Cochran-Mantel-Haenszel|||||6.45|0.55|0.3144
91547039|NCT05198310|182974520|SUPERIORITY||Odds Ratio (OR)|0.97||||0.956|TWO_SIDED|95.0|0.28|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.28|0.9560
91547040|NCT05198310|182974521|SUPERIORITY|||||||0.4667|||||||Fisher exact test|||||||0.4667
91547041|NCT05198310|182974521|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.0000
91547042|NCT05198310|182974521|SUPERIORITY||Odds Ratio (OR)|1.95||||0.5789|TWO_SIDED|95.0|0.17|22.3|||Cochran-Mantel-Haenszel|||||22.30|0.17|0.5789
91547043|NCT05198310|182974521|SUPERIORITY||Odds Ratio (OR)|6.12||||0.0799|TWO_SIDED|95.0|0.62|60.1|||Cochran-Mantel-Haenszel|||||60.10|0.62|0.0799
91547044|NCT05198310|182974521|SUPERIORITY||Odds Ratio (OR)|0.28||||0.1034|TWO_SIDED|95.0|0.06|1.35|||Cochran-Mantel-Haenszel|||||1.35|0.06|0.1034
91547045|NCT04093752|182974577|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% noninferiority (NI) boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common standard deviation (SD) of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.49|||||TWO_SIDED|95.0|-1.69|-1.29||||||||-1.29|-1.69|
91547046|NCT04093752|182974577|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.54|||||TWO_SIDED|95.0|-1.74|-1.34||||||||-1.34|-1.74|
91547047|NCT04093752|182974578|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.29|||||TWO_SIDED|95.0|-1.49|-1.09||||||||-1.09|-1.49|
91547048|NCT04093752|182974579|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-7.4|-5.6|||Mixed Models Analysis|||||-5.6|-7.4|<0.001
91547049|NCT04093752|182974579|SUPERIORITY||LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|95.0|-9.5|-7.6|||Mixed Models Analysis|||||-7.6|-9.5|<0.001
91547050|NCT04093752|182974579|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-9.6|-7.7|||Mixed Models Analysis|||||-7.7|-9.6|<0.001
91547051|NCT04093752|182974580|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.001|TWO_SIDED|95.0|8.94|23.64|||Regression, Logistic|||||23.64|8.94|<0.001
91547052|NCT04093752|182974580|SUPERIORITY||Odds Ratio (OR)|28.76|||<|0.001|TWO_SIDED|95.0|16.72|49.49|||Regression, Logistic|||||49.49|16.72|<0.001
91547053|NCT04093752|182974580|SUPERIORITY||Odds Ratio (OR)|25.27|||<|0.001|TWO_SIDED|95.0|14.88|42.95|||Regression, Logistic|||||42.95|14.88|<0.001
91547054|NCT04093752|182974581|SUPERIORITY||Odds Ratio (OR)|82.54||||0.002|TWO_SIDED|95.0|5.13|1327.81|||Regression, Logistic|||||1327.81|5.13|0.002
91547055|NCT04093752|182974581|SUPERIORITY||Odds Ratio (OR)|124.76|||<|0.001|TWO_SIDED|95.0|7.79|1997.01|||Regression, Logistic|||||1997.01|7.79|<0.001
91547056|NCT04093752|182974581|SUPERIORITY||Odds Ratio (OR)|184.9|||<|0.001|TWO_SIDED|95.0|11.59|2950.73|||Regression, Logistic|||||2950.73|11.59|<0.001
91547057|NCT04093752|182974582|SUPERIORITY||LS Mean Difference|-12.3|||<|0.001|TWO_SIDED|95.0|-18.3|-6.3|||Mixed Models Analysis|||||-6.3|-18.3|<0.001
91547058|NCT04093752|182974582|SUPERIORITY||LS Mean Difference|-20.0|||<|0.001|TWO_SIDED|95.0|-26.1|-13.9|||Mixed Models Analysis|||||-13.9|-26.1|<0.001
91547059|NCT04093752|182974582|SUPERIORITY||LS Mean Difference|-18.6|||<|0.001|TWO_SIDED|95.0|-24.6|-12.5|||Mixed Models Analysis|||||-12.5|-24.6|<0.001
91547060|NCT04093752|182974583|SUPERIORITY||LS Mean Difference|-34.2|||<|0.001|TWO_SIDED|95.0|-40.1|-28.3|||Mixed Models Analysis|||||-28.3|-40.1|<0.001
91547061|NCT04093752|182974583|SUPERIORITY||LS Mean Difference|-40.6|||<|0.001|TWO_SIDED|95.0|-46.7|-34.6|||Mixed Models Analysis|||||-34.6|-46.7|<0.001
91547062|NCT04093752|182974583|SUPERIORITY||LS Mean Difference|-41.8|||<|0.001|TWO_SIDED|95.0|-47.9|-35.8|||Mixed Models Analysis|||||-35.8|-47.9|<0.001
91547063|NCT04093752|182974584|SUPERIORITY||Odds Ratio (OR)|21.89|||<|0.001|TWO_SIDED|95.0|11.63|41.2|||Regression, Logistic|||||41.20|11.63|<0.001
91547064|NCT04093752|182974584|SUPERIORITY||Odds Ratio (OR)|43.79|||<|0.001|TWO_SIDED|95.0|22.96|83.5|||Regression, Logistic|||||83.50|22.96|<0.001
91547065|NCT04093752|182974584|SUPERIORITY||Odds Ratio (OR)|48.41|||<|0.001|TWO_SIDED|95.0|25.34|92.49|||Regression, Logistic|||||92.49|25.34|<0.001
91547066|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.81|-0.13|||ANCOVA|||Hyperglycemia||-0.13|-0.81|0.007
91547067|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.11|-0.43|||ANCOVA|||Hyperglycemia||-0.43|-1.11|<0.001
91547068|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-1.05|-0.36|||ANCOVA|||Hyperglycemia||-0.36|-1.05|<0.001
91547069|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|-0.14||||0.384|TWO_SIDED|95.0|-0.46|0.18|||ANCOVA|||Hypoglycemia||0.18|-0.46|0.384
91547070|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|-0.17||||0.307|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Hypoglycemia||0.16|-0.49|0.307
91547071|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|-0.22||||0.184|TWO_SIDED|95.0|-0.55|0.11|||ANCOVA|||Hypoglycemia||0.11|-0.55|0.184
91547072|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.03|2.59|||ANCOVA|||Treatment Satisfaction Score||2.59|1.03|<0.001
91547073|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|0.84|2.41|||ANCOVA|||Treatment Satisfaction Score||2.41|0.84|<0.001
91547074|NCT04093752|182974585|SUPERIORITY||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|0.89|2.47|||ANCOVA|||Treatment Satisfaction Score||2.47|0.89|<0.001
91547075|NCT00715884|182974597|NON_INFERIORITY_OR_EQUIVALENCE|The null inferiority hypothesis was that the upper limit of the 95% confidence interval is equal or greater than the non-inferiority margin 5%. The alternative non-inferiority hypothesis for this study assumed that the upper limit of the 95% confidence interval would be less than the non-inferiority margin 5%.|Difference between TLF rates|2.58|||||ONE_SIDED|95.0||5.55||In the CYPHER® ELITE™ arm the TLF rate was 5.36% (23/429) compared with 2.78% (6/216) in the CYPHER® Bx VELOCITY® arm, a difference in rates of 2.58%, upper limit of 95% two sided confidence interval of 5.55%.||||Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.||5.55||
91547076|NCT00715884|182974598|SUPERIORITY_OR_OTHER||Difference between event rates|-0.4||||0.549|TWO_SIDED|95.0|-1.3|1.0|||Fisher Exact|||||1.0|-1.3|0.549
91547077|NCT00715884|182974599|SUPERIORITY_OR_OTHER||Difference between event rates|13.8|||<|0.001|TWO_SIDED|95.0|9.2|18.9|||Fisher Exact|||||18.9|9.2|<.001
91547078|NCT00715884|182974600|SUPERIORITY_OR_OTHER||Difference between event rates|0.7||||0.724|TWO_SIDED|95.0|-2.2|4.2|||Fisher Exact|||||4.2|-2.2|0.724
91547079|NCT00715884|182974601|SUPERIORITY_OR_OTHER||Difference between event rates|-1.3||||0.407|TWO_SIDED|95.0|-3.5|1.4|||Fisher Exact|||||1.4|-3.5|0.407
91547080|NCT00715884|182974602|SUPERIORITY_OR_OTHER||Difference between event rates|2.11||||0.203|TWO_SIDED|95.0|-0.84|4.48|||Fisher Exact|||||4.48|-0.84|0.203
91547081|NCT00715884|182974603|SUPERIORITY_OR_OTHER||Difference between event rates|2.35||||0.22|TWO_SIDED|95.0|-1.24|5.28|||Fisher Exact|||||5.28|-1.24|0.22
91547082|NCT00715884|182974604|SUPERIORITY_OR_OTHER||Difference between event rates|2.83||||0.166|TWO_SIDED|95.0|-1.28|6.26|||Fisher Exact|||||6.26|-1.28|0.166
91547083|NCT00715884|182974605|SUPERIORITY_OR_OTHER||Difference between event rates|2.59||||0.2|TWO_SIDED|95.0|-1.35|5.85|||Fisher Exact|||||5.85|-1.35|0.200
91547084|NCT00715884|182974606|SUPERIORITY_OR_OTHER||Difference between event rates|11.56||||0.14|TWO_SIDED|95.0|-3.73|24.64|||Fisher Exact|||||24.64|-3.73|0.140
91547085|NCT00715884|182974607|SUPERIORITY_OR_OTHER||Difference between event rates|5.17||||0.17|TWO_SIDED|95.0|-2.03|10.83|||Fisher Exact|||||10.83|-2.03|0.170
91547086|NCT00715884|182974608|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-5.61|5.43|||Fisher Exact|||||5.43|-5.61|1.0
91547087|NCT00715884|182974609|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-1.92|1.63|||Fisher Exact|||||1.63|-1.92|1.0
91547088|NCT00715884|182974610|SUPERIORITY_OR_OTHER||Difference between event rates|0.49||||0.801|TWO_SIDED|95.0|-2.73|2.91|||Fisher Exact|||||2.91|-2.73|0.801
91547089|NCT00715884|182974611|SUPERIORITY_OR_OTHER||Difference between event rates|-0.92||||0.341|TWO_SIDED|95.0|-3.56|0.6|||Fisher Exact|||||0.60|-3.56|0.341
91547090|NCT00715884|182974612|SUPERIORITY_OR_OTHER||Difference between event rates|0.0||||1|TWO_SIDED|95.0|-2.14|1.28|||Fisher Exact|||||1.28|-2.14|1.00
91547091|NCT00715884|182974613|SUPERIORITY_OR_OTHER||Difference between event rates|0.47||||0.668|TWO_SIDED|95.0|-1.72|1.96|||Fisher Exact|||||1.96|-1.72|0.668
91547092|NCT03930342|182974616|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.83|1.07|||Regression, Logistic|Used marginal standardization to estimate relative risk from logistic regression||Results here reflect analysis of the relative risk for AEP that is a combination of risk from baseline to the 3 month timepoint and risk between the 3 month timepoint and 6 month timepoint. This reflects changes in AEP risk across the course of exposure to the intervention (baseline to 3 month) and enduring change post-exposure (3 months to 6 months)||1.07|0.83|
91547093|NCT02742519|182974620|SUPERIORITY|||||||0.2121|||||||t-test, 2 sided|||||||0.2121
91547094|NCT01872078|182974629|SUPERIORITY_OR_OTHER||Ratio (%)|87.04|||||TWO_SIDED|95.0|58.52|129.47||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||129.47|58.52|
91547095|NCT01872078|182974629|SUPERIORITY_OR_OTHER||Ratio (%)|78.76|||||TWO_SIDED|95.0|53.41|116.16||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||116.16|53.41|
91547096|NCT01872078|182974629|SUPERIORITY_OR_OTHER||Ratio (%)|47.99|||||TWO_SIDED|95.0|32.73|70.36||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||70.36|32.73|
91547097|NCT01091168|182974630|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.673|TWO_SIDED|95.0|0.86|1.25|||Cochran-Mantel-Haenszel|||Kaplan-Meier curves and life tables by treatment arm were provided. Confidence intervals on the median were calculated using the Brookmeyer and Crowley method. Hazard ratio and 95% confidence intervals were reported. A stratified Cox proportional model was performed to compare the two treatment arms taking into account the stratification factors (except centre) used at the time of randomisation.||1.25|0.86|0.673
91547098|NCT01091168|182974631|SUPERIORITY|||||||0.0424|||||||Log Rank|||The disease control rate (DCR) were compared in the ITT population and in the population evaluable for response between the 2 arms with a cochran Mantel Haenszel, stratified on WHO performance status at baseline, number of prior chemotherapy lines for the treatment of disease and disease measurability at Baseline.||||0.0424
91547099|NCT01091168|182974632|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4927|TWO_SIDED|95.0|0.8|1.12|||Log Rank|||PFS was compared between the 2 treatment arms by the log-rank test procedure with the 5 % significant level, stratified on the stratification factors (except study site) as specified at the time of randomisation. Os was analysed using Kaplan-Meir method and summarized with median and 95% CI of the median||1.12|0.8|0.4927
91547100|NCT04052516|182974639|OTHER|Cochran-Mantel-Haenszal test|Odds Ratio (OR)|1.7||||0.2991|TWO_SIDED|95.0|0.62|4.63|||Cochran-Mantel-Haenszel|||||4.63|0.62|0.2991
91547101|NCT04052516|182974639|OTHER|Cochran-Mantel-Haenszel Test|Odds Ratio (OR)|2.01||||0.1386|TWO_SIDED|95.0|0.8|5.08|||Cochran-Mantel-Haenszel|||||5.08|0.80|0.1386
91547102|NCT04172441|182974671|SUPERIORITY||Difference in LS means|-5.21||||0.0037|TWO_SIDED|95.0|-8.29|-2.13|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebo||-2.13|-8.29|0.0037
91765556|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.04|||||TWO_SIDED|95.0|0.81|1.34|||ANOVA|The ANOVA model on the logarithm (log)10 transformation of the concentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.34|0.81|
91547103|NCT04172441|182974672|SUPERIORITY||Difference in LS means|-30.93||||0.0238|TWO_SIDED|95.0|-56.8|-5.05|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: Total amount of carbohydrates administered (regardless of route) per day in patients treated with dasiglucagon = total amount of carbohydrates administered (regardless of route) per day in patients treated with placebo||-5.05|-56.80|0.0238
91547104|NCT01180634|182974715|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0715|TWO_SIDED|95.0|0.96|1.84||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.84|0.96|0.0715
91547105|NCT01180634|182974716|SUPERIORITY||LSMean difference|1.41||||0.0213|TWO_SIDED|95.0|0.21|2.6|||Repeared Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.60|0.21|0.0213
91547106|NCT01180634|182974717|SUPERIORITY||LSMean difference|-0.63||||0.0002|TWO_SIDED|95.0|-0.95|-0.3|||Repeated Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||-0.30|-0.95|0.0002
91547107|NCT01180634|182974718|SUPERIORITY||LSMean difference|0.28||||0.8335|TWO_SIDED|95.0|-2.3|2.85|||Repeated Measures Model||Estimates were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, ≥ 55%), and Baseline value.|||2.85|-2.30|0.8335
91547108|NCT01180634|182974719|SUPERIORITY||LSMean difference|2.42||||0.0122|TWO_SIDED|95.0|0.53|4.31|||Repeated Measures Model|||||4.31|0.53|0.0122
91547109|NCT01180634|182974720|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3|TWO_SIDED|95.0|0.6|1.12||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.12|0.60|0.3000
91547110|NCT01180634|182974721|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.47|2.04||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.04|0.47|0.8670
91547111|NCT06311084|182974727|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547112|NCT06311084|182974728|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91765557|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.19|||||TWO_SIDED|95.0|0.95|1.49|||ANOVA|The ANOVA model on the log10 transformation of theconcentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.49|0.95|
91547113|NCT06311084|182974729|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547114|NCT06311084|182974730|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547115|NCT06311084|182974731|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547116|NCT06311084|182974732|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547117|NCT06311084|182974733|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547118|NCT06311084|182974734|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547119|NCT06311084|182974735|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547120|NCT06311084|182974736|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547121|NCT06311084|182974737|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547122|NCT06311084|182974738|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547123|NCT06311084|182974739|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547124|NCT06311084|182974740|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547125|NCT06311084|182974741|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91547126|NCT04725240|182974742|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
91547127|NCT04725240|182974743|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
91547128|NCT04725240|182974744|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
91547129|NCT04725240|182974745|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
91547130|NCT04501861|182974805|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.|Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.043|0.022|||Mixed Models Analysis|||||0.022|-0.043|0.53
91547131|NCT04501861|182974805|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who with preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 52 and in vasopressin group is 40. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.022||||0.26|TWO_SIDED|95.0|-0.061|0.016|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.016|-0.061|0.26
91547132|NCT04501861|182974805|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who without preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 31 and in vasopressin group is 29. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.0035||||0.88|TWO_SIDED|95.0|-0.05|0.043|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients without pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.043|-0.05|0.88
91547133|NCT04501861|182974806|EQUIVALENCE|Imbalanced confounders such as female, coronary artery disease, preoperative ejection fraction, surgery type, primary or repeat surgery, and bypass time were additionally adjusted. A different inverse probability of treatment weighting was fit for secondary analysis and a linear mixed regression model with random intercept to account for intra-week correlation to estimate the effect of norepinephrine on right ventricular free wall strain using the new obtained stabilized weights|Mean Difference (Final Values)|-1.8||||0.37|TWO_SIDED|95.0|-6.0|2.3|||Mixed Models Analysis|||||2.3|-6.0|0.37
91547134|NCT04501861|182974806|EQUIVALENCE|We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by considering patients who have preoperative pulmonary hypertension. The number of patients in norepinephrine group is 34 and in vasopressin group is 28. The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-2.1||||0.39|TWO_SIDED|95.0|-7.1|2.8|||Mixed Models Analysis|||RV free wall strain compare between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension;||2.8|-7.1|0.39
91765558|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.26|||||TWO_SIDED|95.0|0.98|1.63|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.63|0.98|
91765559|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.48|||||TWO_SIDED|95.0|1.18|1.85|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.85|1.18|
91765560|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMT ratio for anti-HPV-16 antibody|1.21|||||TWO_SIDED|95.0|0.94|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|0.94|
91547135|NCT04501861|182974806|EQUIVALENCE|We're going to explore the interaction between preoperative pulmonary arterial hypertension status and treatment group by equivalence analysis. The number of patients in norepinephrine group is 22 and in vasopressin group is 18.The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-1.5||||0.63|TWO_SIDED|95.0|-7.6|4.6|||Mixed Models Analysis|||"We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by separately considering patients who did not have preoperative pulmonary hypertension.~Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension."||4.6|-7.6|0.63
91547136|NCT04258709|182974829|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||.1200
91547137|NCT04258709|182974829|SUPERIORITY||Odds Ratio (OR)|0.593||||0.0474|TWO_SIDED|95.0|0.352|0.9907|||Regression, Logistic||Adjusted for race, Iowa Infant Feeding Attitudes Score at baseline, infant gestational age, NICU admission, maternal age at enrollment, WIC enrollment at baseline, maternal pre-pregnancy BMI. This is an adjusted odds ratio.|||.9907|.352|.0474
91547138|NCT04258709|182974830|SUPERIORITY|||||||0.5201|||||||t-test, 1 sided|||||||.5201
91547139|NCT04258709|182974830|SUPERIORITY||Slope|0.1399||||0.9178|TWO_SIDED|95.0|-2.5299|2.8098|||Regression, Linear|||||2.8098|-2.5299|.9178
91547140|NCT04258709|182974831|SUPERIORITY|||||||0.8614|||||||t-test, 1 sided|||||||.8614
91547141|NCT04258709|182974831|SUPERIORITY||Odds Ratio (OR)|1.0763||||0.7836|TWO_SIDED|95.0|0.6364|1.8216|||Regression, Logistic|||||1.8216|.6364|.7836
91547142|NCT04258709|182974832|SUPERIORITY|||||||0.9788|||||||Chi-squared|||||||.9788
91547143|NCT04258709|182974832|SUPERIORITY||Odds Ratio (OR)|1.0307||||0.9119|TWO_SIDED|95.0|0.603|1.7067|||Regression, Logistic|||||1.7067|.603|.9119
91547144|NCT04258709|182974833|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.2173
91547145|NCT04258709|182974834|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.5209|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.5209
91547146|NCT04258709|182974837|SUPERIORITY|||||||0.4258|||||||Chi-squared|||||||.4258
91547147|NCT04258709|182974837|SUPERIORITY||Odds Ratio (OR)|0.8882||||0.6246|TWO_SIDED|95.0|0.5523|1.4283|||Regression, Logistic|||||1.4283|.5523|.6246
91547148|NCT04258709|182974838|SUPERIORITY|||||||0.5613|||||||Chi-squared|||||||.5613
91547149|NCT04258709|182974838|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4206|1.2178|||Regression, Logistic|||||1.2178|.4206|.2173
91547150|NCT04258709|182974839|SUPERIORITY|||||||0.6291|||||||Chi-squared|||||||.6291
91547151|NCT04258709|182974839|SUPERIORITY||Odds Ratio (OR)|1.1955||||0.5426|TWO_SIDED|95.0|0.8745|1.3931|||Regression, Logistic|||||1.3931|.8745|.5426
91547152|NCT04258709|182974840|SUPERIORITY|||||||0.9071|||||||Chi-squared|||||||.9071
91765561|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.24|||||TWO_SIDED|95.0|1.0|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|1.00|
91547153|NCT04258709|182974840|SUPERIORITY||Odds Ratio (OR)|1.0233||||0.9328|TWO_SIDED|95.0|0.7751|1.2084|||Regression, Logistic|||||1.2084|.7751|.9328
91547154|NCT04258709|182974841|SUPERIORITY||Slope|0.8213||||0.5548|TWO_SIDED|95.0|-1.9161|3.5588|||Regression, Linear|||||3.5588|-1.9161|.5548
91547155|NCT04258709|182974842|SUPERIORITY||Slope|1.2412||||0.3861|TWO_SIDED|95.0|-1.5771|4.0594|||Regression, Linear|||||4.0594|-1.5771|.3861
91547156|NCT04258709|182974843|SUPERIORITY|||||||0.4779|||||||t-test, 1 sided|||||||.4779
91547157|NCT04258709|182974844|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91547158|NCT04258709|182974844|SUPERIORITY||Odds Ratio (OR)|0.9508||||0.9163|TWO_SIDED|95.0|0.3669|2.4621|||Regression, Logistic|||||2.4621|.3669|.9163
91765562|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.63|1.02|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).||1.02|-3.63|
91765563|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.18|0.94|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.94|-3.18|
91547159|NCT04258709|182974845|SUPERIORITY||Odds Ratio (OR)|1.1084||||0.8031|TWO_SIDED|95.0|0.4937|2.4882|||Regression, Logistic|||||2.4882|.4937|.8031
91547160|NCT04258709|182974846|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8175|TWO_SIDED|95.0|0.3882|3.3161|||Regression, Logistic|||||3.3161|.3882|.8175
91547161|NCT04258709|182974847|SUPERIORITY||Odds Ratio (OR)|0.6964||||0.434|TWO_SIDED|95.0|0.2813|1.7241|||Regression, Logistic|||||1.7241|.2813|.434
91547162|NCT04258709|182974848|SUPERIORITY||Odds Ratio (OR)|1.2533||||0.4968|TWO_SIDED|95.0|0.6534|2.4041|||Regression, Logistic|||||2.4041|.6534|.4968
91547163|NCT04258709|182974849|SUPERIORITY||Odds Ratio (OR)|1.0288||||0.9005|TWO_SIDED|95.0|0.659|1.6062|||Regression, Logistic|||||1.6062|.659|.9005
91547164|NCT04258709|182974850|SUPERIORITY||Slope|-1.4018||||0.127|TWO_SIDED|95.0|-3.2052|0.4015|||Regression, Linear|||||.4015|-3.2052|.127
91547165|NCT04258709|182974851|SUPERIORITY||Slope|-1.8958||||0.07|TWO_SIDED|95.0|-3.9475|0.1559|||Regression, Linear|||||.1559|-3.9475|.07
91547166|NCT04258709|182974852|SUPERIORITY||Slope|-0.506||||0.6299|TWO_SIDED|95.0|-2.574|1.562|||Regression, Linear|||||1.562|-2.574|.6299
91547167|NCT04258709|182974853|SUPERIORITY||Odds Ratio (OR)|0.7573||||0.3835|TWO_SIDED|95.0|0.4029|1.4138|||Regression, Logistic|||||1.4138|.4029|.3835
91547168|NCT04258709|182974854|SUPERIORITY||Odds Ratio (OR)|0.784||||0.459|TWO_SIDED|95.0|0.409|1.4912|||Regression, Logistic|||||1.4912|.409|.459
91547169|NCT04258709|182974855|SUPERIORITY||Odds Ratio (OR)|0.9338||||0.8499|TWO_SIDED|95.0|0.458|1.9039|||Regression, Logistic|||||1.9039|.458|.8499
91547170|NCT03958955|182974872|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having an IGA score of 0 (clear) or 1 (almost clear) at Week 6.|||0.09|-0.37|0.4531
91547171|NCT03958955|182974875|SUPERIORITY||Attributable risk|0.07||||0.5|TWO_SIDED|95.0|-0.02|0.17||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success (i.e. no lesion-specific treatment-related AEs) of delgocitinib compared to vehicle. Exact p-value of McNemar's test.|||0.17|-0.02|0.5000
91547172|NCT03958955|182974876|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib vs vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|||0.09|-0.37|0.4531
91547173|NCT03958955|182974877|SUPERIORITY||Attributable risk|0.0||||1|TWO_SIDED|95.0|-0.22|0.22||Exact p-value of McNemar's test.|McNemar||||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|0.22|-0.22|1.0000
91547174|NCT03958955|182974878|SUPERIORITY|||||||0.5797||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|Erythema is scored as 0=absent, 1=pink, faint, 2=red, 3=dark red, purple/violaceous/crusted/haemorrhagic. P-value of the Wilcoxon signed rank test.||||||0.5797
91547175|NCT03958955|182974879|SUPERIORITY|||||||0.7862||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|P-value of the Wilcoxon signed rank test.||Total skin disease activity score is the sum of the scores for erythema, scaling/hyperkeratosis, and oedema/infiltration. Total skin disease activity score ranges from 0 to 7 with lower score indicating better state.||||0.7862
91547176|NCT04638829|182974886|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91547177|NCT04638829|182974887|OTHER|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
91547178|NCT04638829|182974888|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
91547179|NCT04638829|182974889|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91547180|NCT02807636|182974895|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0073|TWO_SIDED|95.0|0.7|0.96||inverse normal combination|Log Rank|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||0.96|0.70|0.0073
91547181|NCT02807636|182974896|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.023|TWO_SIDED|95.0|0.73|1.0||one-sided, inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.0|0.73|0.0230
91547182|NCT02807636|182974897|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3968|TWO_SIDED|95.0|0.82|1.16|||Log Rank|one-sided||Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.16|0.82|0.3968
91547183|NCT02807636|182974902|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0373|TWO_SIDED|95.0|0.73|1.01||inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.01|0.73|0.0373
91547184|NCT02807636|182974903|SUPERIORITY||Difference in Event Free Rate|5.0||||0.1509|TWO_SIDED|95.0|-1.82|11.81|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||11.81|-1.82|0.1509
91547185|NCT02807636|182974904|SUPERIORITY||Difference in Event Free Rate|3.36||||0.3761|TWO_SIDED|95.0|-4.08|10.79|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||10.79|-4.08|0.3761
91547186|NCT02807636|182974905|SUPERIORITY||Difference in Event Free Rate|-8.29||||0.0083|TWO_SIDED|95.0|-14.45|-2.13|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||-2.13|-14.45|0.0083
91547187|NCT02807636|182974906|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0542|TWO_SIDED|95.0|0.64|1.0|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.00|0.64|0.0542
91547188|NCT02807636|182974907|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6139|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||Strata are: PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.19|0.74|0.6139
91547189|NCT02807636|182974908|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.554|TWO_SIDED|95.0|0.86|1.32|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.32|0.86|0.5540
91547190|NCT02807636|182974909|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.0241|TWO_SIDED|95.0|1.03|1.62|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.62|1.03|0.0241
91547191|NCT02807636|182974913|SUPERIORITY||Hazard Ratio (HR)|1.42||||1|TWO_SIDED|95.0|1.19|1.69|||Log Rank|||Stratification factors: PD-L1 status and Bajorin risk score/presence of liver metastases and investigator choice of chemotherapy.||1.69|1.19|1.0000
91547192|NCT03175029|182974922|SUPERIORITY||Mean Difference (Final Values)|10.552|||<|0.001|TWO_SIDED|95.0|5.514|15.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the TAC-302 group||15.590|5.514|<0.001
91765564|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.|GMC ratio for anti-HPV-16 antibody|0.87|||||TWO_SIDED|95.0|0.7|1.08|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||1.08|0.70|
91547193|NCT03175029|182974922|SUPERIORITY||Mean Difference (Final Values)|-0.826||||0.819|TWO_SIDED|95.0|-8.676|7.023|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the Placebo group||7.023|-8.676|0.819
91547194|NCT03175029|182974922|SUPERIORITY||Mean Difference (Final Values)|11.378|STANDARD_ERROR_OF_MEAN|4.454||0.015|TWO_SIDED|95.0|2.345|20.411|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BCI from baseline to Week 12||20.411|2.345|0.015
91547195|NCT03175029|182974923|SUPERIORITY||Mean Difference (Final Values)|10.604|STANDARD_DEVIATION|8.76|<|0.001|TWO_SIDED|95.0|5.753|15.455|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the TAC-302 group||15.455|5.753|<0.001
91547196|NCT03175029|182974923|SUPERIORITY||Mean Difference (Final Values)|4.926|STANDARD_DEVIATION|7.62||0.138|TWO_SIDED|95.0|-2.121|11.973|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the Placebo group||11.973|-2.121|0.138
91547197|NCT03175029|182974923|SUPERIORITY||Mean Difference (Final Values)|5.678|STANDARD_ERROR_OF_MEAN|3.861||0.157|TWO_SIDED|95.0|-2.375|13.731|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12||13.731|-2.375|0.157
91547198|NCT03175029|182974924|SUPERIORITY||Mean Difference (Final Values)|10.91|STANDARD_DEVIATION|26.48||0.006|TWO_SIDED|95.0|3.22|18.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||18.59|3.22|0.006
91547199|NCT03175029|182974924|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_DEVIATION|20.09||0.57|TWO_SIDED|95.0|-6.27|11.1|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.10|-6.27|0.570
91547200|NCT03175029|182974924|SUPERIORITY||Mean Difference (Final Values)|8.49|STANDARD_ERROR_OF_MEAN|6.24||0.178|TWO_SIDED|95.0|-3.96|20.95|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||20.95|-3.96|0.178
91547201|NCT03175029|182974925|SUPERIORITY||Mean Difference (Final Values)|18.41|STANDARD_DEVIATION|24.39|<|0.001|TWO_SIDED|95.0|9.13|27.69|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||27.69|9.13|<0.001
91547202|NCT03175029|182974925|SUPERIORITY||Mean Difference (Final Values)|2.88|STANDARD_DEVIATION|15.7||0.489|TWO_SIDED|95.0|-5.81|11.58|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.58|-5.81|0.489
91547203|NCT03175029|182974925|SUPERIORITY||Mean Difference (Final Values)|15.53|STANDARD_ERROR_OF_MEAN|6.96||0.031|TWO_SIDED|95.0|1.48|29.58|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||29.58|1.48|0.031
91547204|NCT03175029|182974926|SUPERIORITY||Mean Difference (Final Values)|23.57|STANDARD_DEVIATION|25.54|<|0.001|TWO_SIDED|95.0|11.26|35.88|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||35.88|11.26|<0.001
91547205|NCT03175029|182974926|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|17.18||0.708|TWO_SIDED|95.0|-10.19|14.4|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||14.40|-10.19|0.708
91547206|NCT03175029|182974926|SUPERIORITY||Mean Difference (Final Values)|21.47|STANDARD_ERROR_OF_MEAN|9.02||0.025|TWO_SIDED|95.0|2.96|39.98|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||39.98|2.96|0.025
91547207|NCT04382898|182974966|SUPERIORITY|||||||0.1041|||||||Fisher Exact|||||||0.1041
91547208|NCT04382898|182974972|SUPERIORITY|||||||0.0541|||||||Binomial test|||||||0.0541
91765565|NCT00250276|183420146|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.|GMC ratio for anti-HPV-18 antibody|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.97|0.66|
91765566|NCT00555217|183420162|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.3|TWO_SIDED|95.0|0.7|1.12|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.12|0.70|0.30
91765567|NCT00555217|183420163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.1|TWO_SIDED|95.0|0.58|1.05|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.05|0.58|0.10
91765568|NCT02781610|183420169|NON_INFERIORITY|The non-inferiority margin is -3.5%.|Mean Difference (Final Values)|-0.7||||0.0164|TWO_SIDED|95.0|-3.3|2.0|||ANOVA|Adjusted for four dichotomous randomization strata.||The ERR non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population for 93% power assuming 2-sided alpha=0.05 with 155 PP participants per arm. Difference between ERR treatment duration arms is ERR-10 - ERR-14.||2.0|-3.3|0.0164
91547209|NCT05229120|182974973|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.124|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||A single-sided paired-samples t-test comparing k-values at baseline to k-values at follow-up (approximately 4 weeks after baseline assessment) was examined. Given that k-values are typically skewed (and to be consistent with the existing literature) we used a log-k as our outcome variable.||||.124
91547210|NCT05229120|182974974|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.219|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 14.||Changes in consideration of future consequences (parenting) was evaluated using one-sided paired samples t-tests.||||.219
91547211|NCT05229120|182974975|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 5||Performed a one-sided paired samples t-test examining changes in both positive parenting.||||.50
91547212|NCT05229120|182974975|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.187|TWO_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in negative parenting.||||.187
91547213|NCT05229120|182974976|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.498|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental involvement using a paired-samples t-test.||||.498
91765569|NCT02781610|183420170|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.568|TWO_SIDED|95.0|-1.3|1.1|||ANOVA|Adjusted for four dichotomous randomization strata.||The NERR superiority test was a priori designed to be conducted on the Intent-to-Treat (ITT) population for 91% power to detect a 2.5% difference, assuming 2-sided alpha=0.05 with 285 ITT participants per arm. Difference between NERR treatment duration arms is NERR-21 - NERR-14.||1.1|-1.3|0.568
91765570|NCT02781610|183420171|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.546|TWO_SIDED|95.0|-2.4|4.6|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||4.6|-2.4|0.546
91765571|NCT02781610|183420172|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.14|TWO_SIDED|95.0|-3.7|0.5|||t-test, 2 sided|||Difference between NERR treatment duration arms is NERR-21 - NERR-14.||0.5|-3.7|0.140
91765572|NCT02781610|183420173|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.563|TWO_SIDED|95.0|-0.42|0.77|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||0.77|-0.42|0.563
91765573|NCT02781610|183420174|SUPERIORITY|Difference between NERR treatment duration arms is NERR-21 - NERR-14.|Mean Difference (Final Values)|0.29||||0.083|TWO_SIDED|95.0|-0.04|0.61|||t-test, 2 sided|||||0.61|-0.04|0.083
91765574|NCT01657292|183420175|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||1-sided, significance level = 0.025|Binomial test|||"All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 \>0.5 (with s0=rate of superiority of Oleogel-S10)."||||<0.0001
91547214|NCT05229120|182974976|SUPERIORITY||Mean Difference (Final Values)|1.301||||0.108|TWO_SIDED||||||t-test, 1 sided|||Examined changes in positive parenting using paired samples t-tests||||.108
91547215|NCT05229120|182974976|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.145|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental monitoring using a paired samples t-test||||.145
91547216|NCT05229120|182974976|SUPERIORITY||Mean Difference (Final Values)|-0.688||||0.252|TWO_SIDED||||||t-test, 1 sided|||Examined changes in inconsistent parenting using a paired samples one-sided t-test||||.252
91547217|NCT05229120|182974976|SUPERIORITY||Mean Difference (Final Values)|0.306||||0.382|TWO_SIDED||||||t-test, 1 sided|||Examined changes in corporal punishment using a paired samples one-tailed t-test||||.382
91547218|NCT03932682|182974985|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided confidence interval (CI) for absolute vaccine efficacy (aVE) of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|41.26|||||TWO_SIDED|97.98|21.55|56.02||||||||56.02|21.55|
91547219|NCT03932682|182974986|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided CI for aVE of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|46.9|||||TWO_SIDED|97.5|19.19|65.11||||||||65.11|19.19|
91547220|NCT03932682|182974987|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|54.49|||||TWO_SIDED|95.0|22.55|73.26||||||||73.26|22.55|
91547221|NCT03932682|182974988|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|50.67|||||TWO_SIDED|95.0|32.83|63.77||||||||63.77|32.83|
91547222|NCT03932682|182974989|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|100.0|||||TWO_SIDED|95.0|||||||"The 2-sided 95% confidence interval was calculated with a lower limit of not estimable and an upper limit of 100."|||||
91547223|NCT04321031|182975000|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.02|0.2|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the statistical analysis plan (SAP).||0.20|-0.02|
91547224|NCT04321031|182975000|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-0.03|0.24|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.24|-0.03|
91547225|NCT04321031|182975000|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.03|0.26|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.26|-0.03|
91547226|NCT04321031|182975000|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.04|0.28|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.28|-0.04|
91547227|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.32||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|-0.04|
91547228|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.11|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.11|
91547229|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.07|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.07|
91547230|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.07|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|0.07|
91765575|NCT02663622|183420228|SUPERIORITY||Cox Proportional Hazard|0.13||||0.0274|TWO_SIDED|95.0|0.01|0.62|||Log Rank|Log-rank test stratified by the matched sets||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade III-IV AGFS in days was 135.8 with an SD of 64.66.||0.62|0.01|0.0274
91547231|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|90.0|-0.12|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.12|
91547232|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.04|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.04|
91547233|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|50.0|0.08|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.08|
91547234|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.31||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.31|-0.03|
91547235|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|50.0|0.09|0.26||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|0.09|
91547236|NCT04321031|182975001|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|-0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|-0.03|
91547237|NCT04321031|182975002|SUPERIORITY||Least Square (LS) Mean|-25.98|||||TWO_SIDED|90.0|-58.42|-2.57||||||||-2.57|-58.42|
91547238|NCT04321031|182975002|SUPERIORITY||LS Mean|-35.41|||||TWO_SIDED|90.0|-69.41|-5.42||||||||-5.42|-69.41|
91547239|NCT04321031|182975002|SUPERIORITY||LS Mean|-40.54|||||TWO_SIDED|90.0|-75.55|-7.32||||||||-7.32|-75.55|
91547240|NCT04321031|182975002|SUPERIORITY||LS Mean|-44.74|||||TWO_SIDED|90.0|-81.72|-8.42||||||||-8.42|-81.72|
91765576|NCT02663622|183420229|SUPERIORITY||Cox Proportional Hazard|0.57||||0.0988|TWO_SIDED|95.0|0.3|1.08|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade II-IV AGFS in days was 104.7 with an SD of 72.28.||1.08|0.30|0.0988
91547241|NCT04321031|182975003|SUPERIORITY||LS Mean|-41.82|||||TWO_SIDED|90.0|-62.57|-9.57||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-9.57|-62.57|
91547242|NCT04321031|182975003|SUPERIORITY||LS Mean|-43.33|||||TWO_SIDED|90.0|-62.37|-14.64||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-14.64|-62.37|
91547243|NCT04321031|182975003|SUPERIORITY||LS Mean|-59.35|||||TWO_SIDED|90.0|-73.95|-36.55||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-36.55|-73.95|
91547244|NCT04321031|182975003|SUPERIORITY||LS Mean|-68.21|||||TWO_SIDED|90.0|-79.72|-50.15||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.15|-79.72|
91547245|NCT04321031|182975003|SUPERIORITY||LS Mean|-50.46|||||TWO_SIDED|90.0|-69.53|-19.44||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-19.44|-69.53|
91547246|NCT04321031|182975003|SUPERIORITY||LS Mean|-69.27|||||TWO_SIDED|90.0|-81.08|-50.07||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.07|-81.08|
91547247|NCT04321031|182975003|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|50.0|-34.02|-7.32||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-7.32|-34.02|
91547248|NCT04321031|182975003|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|90.0|-48.51|18.76||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||18.76|-48.51|
91547249|NCT04321031|182975003|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|50.0|-49.4|-23.95||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-23.95|-49.40|
91547250|NCT04321031|182975003|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|90.0|-62.41|2.37||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||2.37|-62.41|
91547251|NCT04321031|182975004|SUPERIORITY||Risk Difference (RD)|0.21|||||TWO_SIDED|90.0|0.09|0.32|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.32|0.09|
91765577|NCT02663622|183420235|SUPERIORITY||Cox Proportional Hazard|1.12||||0.9088|TWO_SIDED|95.0|0.43|2.88|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean OS in days was 319.3 with an SD of 93.83.||2.88|0.43|0.9088
91547252|NCT04321031|182975004|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.15|0.37|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.37|0.15|
91547253|NCT04321031|182975004|SUPERIORITY||Risk Difference (RD)|0.29|||||TWO_SIDED|90.0|0.18|0.39|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.39|0.18|
91547254|NCT04321031|182975004|SUPERIORITY||Risk Difference (RD)|0.31|||||TWO_SIDED|90.0|0.19|0.42|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.42|0.19|
91765578|NCT02663622|183420237|SUPERIORITY||Cox Proportional Hazard|1.27||||0.6131|TWO_SIDED|95.0|0.66|2.46|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean RFS in days was 296.0 with an SD of 115.32.||2.46|0.66|0.6131
91765579|NCT00857857|183420238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.1033|||TWO_SIDED|95.0|0.031|0.449||||||||0.449|0.031|
91765580|NCT00857857|183420238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.265|STANDARD_ERROR_OF_MEAN|0.1048|||TWO_SIDED|95.0|0.053|0.477||||||||0.477|0.053|
91547255|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.04|0.51||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.51|0.04|
91547256|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.37|||||TWO_SIDED|90.0|0.13|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.13|
91547257|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.04|0.49||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.49|0.04|
91547258|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.54|||||TWO_SIDED|90.0|0.26|0.75||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.75|0.26|
91547259|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.34|||||TWO_SIDED|90.0|0.1|0.61||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.61|0.10|
91547260|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.2|0.72||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.72|0.20|
91547261|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|50.0|0.24|0.39||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.39|0.24|
91547262|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|90.0|0.12|0.48||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.48|0.12|
91547263|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|50.0|0.06|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.06|
91765581|NCT00857857|183420238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|STANDARD_ERROR_OF_MEAN|0.0993|||TWO_SIDED|95.0|0.255|0.657||||||||0.657|0.255|
91547264|NCT04321031|182975005|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.06|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.06|
91547265|NCT04321031|182975006|SUPERIORITY||Risk Difference (RD)|-0.05|||||TWO_SIDED|90.0|-0.16|0.02|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.02|-0.16|
91547266|NCT04321031|182975006|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.2|0.03|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.03|-0.20|
91547267|NCT04321031|182975006|SUPERIORITY||Risk Difference (RD)|-0.09|||||TWO_SIDED|90.0|-0.23|0.04|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.04|-0.23|
91547268|NCT04321031|182975006|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.05|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.05|-0.26|
91547269|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.21|0.13||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.13|-0.21|
91547270|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|-0.14|||||TWO_SIDED|90.0|-0.25|0.02||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.02|-0.25|
91547271|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.17|0.17||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.17|-0.17|
91765582|NCT00857857|183420238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.526|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|0.319|0.733||||||||0.733|0.319|
91547272|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|90.0|-0.15|0.22||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.22|-0.15|
91547273|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|-0.22|||||TWO_SIDED|90.0|-0.3|-0.05||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||-0.05|-0.30|
91547274|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.13|0.26||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|-0.13|
91547275|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|50.0|-0.03|0.12||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.12|-0.03|
91547276|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.12|0.23||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|-0.12|
91547277|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|50.0|0.17|0.38||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|0.17|
91765583|NCT00857857|183420239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.0975|||TWO_SIDED|95.0|0.013|0.407||||||||0.407|0.013|
91765584|NCT00857857|183420239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.0988|||TWO_SIDED|95.0|-0.046|0.354||||||||0.354|-0.046|
91765585|NCT00857857|183420239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.303|STANDARD_ERROR_OF_MEAN|0.0937|||TWO_SIDED|95.0|0.113|0.492||||||||0.492|0.113|
91765586|NCT00857857|183420239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.404|STANDARD_ERROR_OF_MEAN|0.0966|||TWO_SIDED|95.0|0.209|0.599||||||||0.599|0.209|
91547278|NCT04321031|182975007|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.06|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.06|
91547279|NCT04321031|182975008|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.01|0.08|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.08|-0.01|
91547280|NCT04321031|182975008|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.09|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.09|-0.02|
91547281|NCT04321031|182975008|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.11|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.11|-0.02|
91547282|NCT04321031|182975008|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.12|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.12|-0.02|
91547283|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
91547284|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.02|0.29||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.29|-0.02|
91547285|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
91547286|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.57||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.57|0.01|
91547287|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.02|
91765587|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.1372|||TWO_SIDED|95.0|-0.302|0.253|||||Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.302|
91547288|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.01|
91547289|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|50.0|0.02|0.16||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.16|0.02|
91547290|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.04|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.04|
91547291|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|50.0|0.06|0.24||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.24|0.06|
91765588|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.1391|||TWO_SIDED|95.0|-0.176|0.387|||||Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.|||0.387|-0.176|
91547292|NCT04321031|182975009|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.01|0.44||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.44|-0.01|
91547293|NCT04321031|182975010|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|0.05|0.31|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.31|0.05|
91547294|NCT04321031|182975010|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.09|0.36|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.36|0.09|
91547295|NCT04321031|182975010|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.1|0.38|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.38|0.10|
91765589|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.239|STANDARD_ERROR_OF_MEAN|0.1319|||TWO_SIDED|95.0|-0.028|0.506|||||Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.|||0.506|-0.028|
91547296|NCT04321031|182975010|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.11|0.4|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.40|0.11|
91547297|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.36||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.36|-0.04|
91547298|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.35|||||TWO_SIDED|90.0|0.15|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.15|
91547299|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.26|||||TWO_SIDED|90.0|0.06|0.46||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.46|0.06|
91547300|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.27|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.27|
91547301|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.38||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|-0.03|
91547302|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|90.0|0.18|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.18|
91547303|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|50.0|0.15|0.28||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.28|0.15|
91547304|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|0.03|
91547305|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|50.0|0.16|0.32||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|0.16|
91547306|NCT04321031|182975011|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|90.0|0.03|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.03|
91547307|NCT05285618|182975021|OTHER|A linear mixed model accounted for repeated measures ('subject\_id' as a random factor). No power calculation was performed, but the sample size (1,485 observations, 6 subjects) supports robust estimation.||||||0.002||||||P-values are unadjusted for multiple comparisons, as the analysis focused on a limited number of predictors. The a priori threshold for statistical significance was set at p\<0.05.|Mixed Models Analysis|||The model tested whether stimulation delay ('abs\_delay'), retinal distance ('dist\_ret'), and their interaction ('abs\_delay:dist\_ret') affect the number of elicited phosphenes ('num\_phosphenes').|We hypothesize that the parameter 'dist\_ret' may influence the number of phosphenes perceived ('num\_phosphenes'), while the roles of 'abs\_delay' and its interaction with 'dist\_ret' may be less pronounced. Further evaluation of these parameters will be conducted in the Results section|||0.002
91547308|NCT04556656|182975028|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.167|TWO_SIDED|95.0|-0.54|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.54|0.1670
91547309|NCT04556656|182975029|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.162||0.1598|TWO_SIDED|95.0|-0.55|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.55|0.1598
91547310|NCT04556656|182975030|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.148||0.4544|TWO_SIDED|95.0|-0.4|0.18|||Mixed Models Analysis|||In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.||0.18|-0.4|0.4544
91765590|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.534|STANDARD_ERROR_OF_MEAN|0.1359|||TWO_SIDED|95.0|0.26|0.809|||||Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.809|0.260|
91765591|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|-0.145|0.253|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.145|
91547311|NCT04556656|182975031|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.156||0.0038|TWO_SIDED|95.0|0.15|0.76|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.76|0.15|0.0038
91765592|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.176|0.228|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.|||0.228|-0.176|
91765593|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|-0.011|0.371|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.|||0.371|-0.011|
91765594|NCT00857857|183420240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.0978|||TWO_SIDED|95.0|0.153|0.548|||||Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.548|0.153|
91547312|NCT04556656|182975031|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.179||0.0135|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis|||From baseline to Week 39||0.80|0.09|0.0135
91547313|NCT04556656|182975031|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.193||0.0351|TWO_SIDED|95.0|0.03|0.79|||Mixed Models Analysis|||From baseline to Week 52||0.79|0.03|0.0351
91547314|NCT04556656|182975031|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.197||0.1683|TWO_SIDED|95.0|-0.12|0.66|||Mixed Models Analysis|||From baseline to Week 65.||0.66|-0.12|0.1683
91547315|NCT04556656|182975031|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.223||0.5315|TWO_SIDED|95.0|-0.3|0.58|||Mixed Models Analysis|||From baseline to Week 78||0.58|-0.30|0.5315
91547316|NCT04556656|182975032|SUPERIORITY||Mean Difference (Final Values)|-21.15|STANDARD_ERROR_OF_MEAN|9.406||0.0253|TWO_SIDED|95.0|-39.66|-2.64|||Mixed Models Analysis||Negative change = improvement.|From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.||-2.64|-39.66|0.0253
91547317|NCT04556656|182975032|SUPERIORITY||Mean Difference (Final Values)|-14.31|STANDARD_ERROR_OF_MEAN|9.853||0.1474|TWO_SIDED|95.0|-33.71|5.08|||Mixed Models Analysis|||From baseline to Week 52.||5.08|-33.71|0.1474
91547318|NCT04556656|182975032|SUPERIORITY||Mean Difference (Final Values)|-24.71|STANDARD_ERROR_OF_MEAN|10.185||0.0159|TWO_SIDED|95.0|-44.76|-4.67|||Mixed Models Analysis|||From baseline to Week 65.||-4.67|-44.76|0.0159
91547319|NCT04556656|182975032|SUPERIORITY||Mean Difference (Final Values)|-22.9|STANDARD_ERROR_OF_MEAN|10.38||0.0283|TWO_SIDED|95.0|-43.34|-2.45|||Mixed Models Analysis|||From baseline to Week 78.||-2.45|-43.34|0.0283
91547320|NCT04556656|182975033|SUPERIORITY||Mean Difference (Final Values)|-38.06|STANDARD_ERROR_OF_MEAN|10.999||0.0007|TWO_SIDED|95.0|-59.74|-16.37|||Mixed Models Analysis|||From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-16.37|-59.74|0.0007
91547321|NCT04556656|182975033|SUPERIORITY||Mean Difference (Final Values)|-20.21|STANDARD_ERROR_OF_MEAN|12.547||0.1087|TWO_SIDED|95.0|-44.95|4.53|||Mixed Models Analysis|||From baseline to Week 52.||4.53|-44.95|0.1087
91547322|NCT04556656|182975033|SUPERIORITY||Mean Difference (Final Values)|-23.92|STANDARD_ERROR_OF_MEAN|11.541||0.0395|TWO_SIDED|95.0|-46.68|-1.16|||Mixed Models Analysis|||From baseline to Week 65.||-1.16|-46.68|0.0395
91547323|NCT04556656|182975033|SUPERIORITY||Mean Difference (Final Values)|-22.23|STANDARD_ERROR_OF_MEAN|13.587||0.1038|TWO_SIDED|95.0|-49.08|4.61|||Mixed Models Analysis|||From baseline to Week 78.||4.61|-49.08|0.1038
91765595|NCT00857857|183420241|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.71|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.56|0.9||||||||0.90|0.56|
91547324|NCT04556656|182975034|SUPERIORITY||Mean Difference (Final Values)|-30.38|STANDARD_ERROR_OF_MEAN|12.902||0.0193|TWO_SIDED|95.0|-55.78|-4.98|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-4.98|-55.78|0.0193
91547325|NCT04556656|182975034|SUPERIORITY||Mean Difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|15.17||0.268|TWO_SIDED|95.0|-46.69|13.02|||Mixed Models Analysis|||From baseline to Week 52.||13.02|-46.69|0.2680
91765596|NCT00857857|183420241|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.66|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.53|0.82||||||||0.82|0.53|
91547326|NCT04556656|182975034|SUPERIORITY||Mean Difference (Final Values)|-22.79|STANDARD_ERROR_OF_MEAN|14.829||0.1255|TWO_SIDED|95.0|-51.97|6.4|||Mixed Models Analysis|||From baseline to Week 65.||6.4|-51.97|0.1255
91547327|NCT04556656|182975034|SUPERIORITY||Mean Difference (Final Values)|-22.72|STANDARD_ERROR_OF_MEAN|17.777||0.2024|TWO_SIDED|95.0|-57.72|12.28|||Mixed Models Analysis|||From baseline to Week 78.||12.28|-57.72|0.2024
91547328|NCT04556656|182975035|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.179||0.2088|TWO_SIDED|95.0|-0.13|0.58|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.58|-0.13|0.2088
91765597|NCT00857857|183420241|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.59|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|95.0|0.47|0.74||||||||0.74|0.47|
91765598|NCT00857857|183420241|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.45|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.36|0.55||||||||0.55|0.36|
91765599|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.1086|||TWO_SIDED|95.0|-0.199|0.24|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes|||0.240|-0.199|
91547329|NCT04556656|182975035|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.188||0.2991|TWO_SIDED|95.0|-0.17|0.57|||Mixed Models Analysis|||From baseline to Week 39.||0.57|-0.17|0.2991
91547330|NCT04556656|182975035|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.205||0.2116|TWO_SIDED|95.0|-0.15|0.66|||Mixed Models Analysis|||From baseline to Week 52.||0.66|-0.15|0.2116
91765600|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.096|0.424|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes|||0.424|-0.096|
91765601|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.1526|||TWO_SIDED|95.0|-0.285|0.333|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes|||0.333|-0.285|
91547331|NCT04556656|182975035|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.215||0.8242|TWO_SIDED|95.0|-0.38|0.47|||Mixed Models Analysis|||From baseline to Week 65.||0.47|-0.38|0.8242
91547332|NCT04556656|182975035|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.5918|TWO_SIDED|95.0|-0.33|0.58|||Mixed Models Analysis|||From baseline to Week 78.||0.58|-0.33|0.5918
91547333|NCT04556656|182975036|SUPERIORITY||Mean Difference (Final Values)|3.16|STANDARD_ERROR_OF_MEAN|1.326||0.0178|TWO_SIDED|95.0|0.55|5.77|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||5.77|0.55|0.0178
91547334|NCT04556656|182975036|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.518||0.0576|TWO_SIDED|95.0|-0.09|5.88|||Mixed Models Analysis|||From baseline to Week 39.||5.88|-0.09|0.0576
91547335|NCT04556656|182975036|SUPERIORITY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.493||0.0418|TWO_SIDED|95.0|0.11|5.99|||Mixed Models Analysis|||From baseline to Week 52.||5.99|0.11|0.0418
91547336|NCT04556656|182975036|SUPERIORITY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.719||0.1775|TWO_SIDED|95.0|-1.06|5.71|||Mixed Models Analysis|||From baseline to Week 65.||5.71|-1.06|0.1775
91547337|NCT04556656|182975036|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.772||0.2627|TWO_SIDED|95.0|-1.5|5.48|||Mixed Models Analysis|||From baseline to Week 78.||5.48|-1.50|0.2627
91547338|NCT04556656|182975037|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.712||0.1586|TWO_SIDED|95.0|-0.4|2.41|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.41|-0.4|0.1586
91547339|NCT04556656|182975037|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.701||0.2144|TWO_SIDED|95.0|-0.51|2.25|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.25|-0.51|0.2144
91547340|NCT04556656|182975037|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.793||0.9119|TWO_SIDED|95.0|-1.65|1.48|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.48|-1.65|0.9119
91547341|NCT04556656|182975037|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.844||0.7339|TWO_SIDED|95.0|-1.38|1.95|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.95|-1.38|0.7339
91547342|NCT04556656|182975037|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.859||0.6213|TWO_SIDED|95.0|-1.27|2.12|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.12|-1.27|0.6213
91547343|NCT04556656|182975038|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.777||0.8205|TWO_SIDED|95.0|-1.71|1.36|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.36|-1.71|0.8205
91547344|NCT04556656|182975038|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.067||0.4028|TWO_SIDED|95.0|-3.0|1.21|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.21|-3.0|0.4028
91547345|NCT04556656|182975038|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.051||0.7577|TWO_SIDED|95.0|-2.4|1.75|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.75|-2.4|0.7577
91547346|NCT04556656|182975038|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|1.158||0.7605|TWO_SIDED|95.0|-2.64|1.93|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.93|-2.64|0.7605
91765602|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.1471|||TWO_SIDED|95.0|-0.229|0.366|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes|||0.366|-0.229|
91765603|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.011|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.277|0.254|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes|||0.254|-0.277|
91547347|NCT04556656|182975038|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.323||0.6694|TWO_SIDED|95.0|-2.05|3.18|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||3.18|-2.05|0.6694
91547348|NCT01566695|182975071|SUPERIORITY||Rate Difference|18.9||||0.0005|TWO_SIDED|95.0|8.3|29.6||2 sided|Stratified Mantel-Haenszel Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||29.6|8.3|0.0005
91547349|NCT01566695|182975075|SUPERIORITY||Rate Difference|21.6|||<|0.0001|TWO_SIDED|95.0|11.9|31.3||2 sided|Stratified Mantel-Haenszel; Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||31.3|11.9|<0.0001
91547350|NCT01566695|182975076|SUPERIORITY|||||||0.4347|||||||Two-Sided Unstratified Log Rank Test|||||||0.4347
91547351|NCT01566695|182975078|SUPERIORITY|HI-E|Rate Difference|10.9||||0.1467|TWO_SIDED|95.0|-2.0|23.7|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.7|-2.0|0.1467
91547352|NCT01566695|182975078|SUPERIORITY|≥ 1.5 g/dL Hemoglobin Increase|Rate Diffrence|17.9||||0.0002|TWO_SIDED|95.0|8.8|26.9|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.9|8.8|0.0002
91547353|NCT01566695|182975078|SUPERIORITY|RBC Transfusion Reduction|Rate Difference|10.9||||0.1431|TWO_SIDED|95.0|-1.9|23.6|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.6|-1.9|0.1431
91547354|NCT01566695|182975079|SUPERIORITY||Rate Difference|17.0||||0.0007|TWO_SIDED|95.0|7.5|26.4|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.4|7.5|0.0007
91547355|NCT01566695|182975082|OTHER||Hazard Ratio (HR)|1.08||||0.6257|TWO_SIDED|95.0|0.79|1.49|||Log Rank||||Cox proportional hazards model with stratifies factors|1.49|0.79|0.6257
91547356|NCT01566695|182975088|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.214
91547357|NCT01566695|182975089|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.446
91765604|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.269|0.302|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes|||0.302|-0.269|
91547358|NCT01566695|182975090|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.248
91547359|NCT01566695|182975091|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.058
91547360|NCT01566695|182975092|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.130
91547361|NCT01566695|182975093|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.123
91547362|NCT01566695|182975094|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.069
91547363|NCT01566695|182975095|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.078
91547364|NCT01566695|182975096|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.073
91547365|NCT01566695|182975097|SUPERIORITY||Common Odds Raatio|0.77||||0.56|TWO_SIDED|95.0|0.54|1.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.30|0.54|0.560
91547366|NCT01566695|182975098|SUPERIORITY||Common Odds Raatio|0.72||||0.48|TWO_SIDED|95.0|0.29|1.78|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.78|0.29|0.480
91547367|NCT01566695|182975099|SUPERIORITY||Common Odds Ratio|1.67||||0.197|TWO_SIDED|95.0|0.76|3.65|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.65|0.76|0.197
91547368|NCT01566695|182975100|SUPERIORITY||Common Odds Ratio|2.14||||0.121|TWO_SIDED|95.0|0.82|5.57|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|5.57|0.82|0.121
91765605|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.1265|||TWO_SIDED|95.0|-0.21|0.301|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour|||0.301|-0.210|
91547369|NCT01566695|182975101|SUPERIORITY||Common Odds Ratio|2.0||||0.075|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.30|0.93|0.075
91547370|NCT01566695|182975102|SUPERIORITY||Common Odds Ratio|1.58||||0.222|TWO_SIDED|95.0|0.76|3.29|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.29|0.76|0.222
91547371|NCT01566695|182975103|SUPERIORITY||Common Odds Ratio|1.65||||0.249|TWO_SIDED|95.0|0.71|3.83|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.83|0.71|0.249
91547372|NCT01566695|182975104|SUPERIORITY||Common Odds Ratio|2.03||||0.082|TWO_SIDED|95.0|0.92|4.48|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.48|0.92|0.082
91547373|NCT01566695|182975105|SUPERIORITY||Common Odds Ratio|1.86||||0.153|TWO_SIDED|95.0|0.79|4.34|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.34|0.79|0.153
91547374|NCT01566695|182975106|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91547375|NCT01566695|182975107|SUPERIORITY|||||||0.046|||||||Fisher Exact|||||||0.046
91547376|NCT01566695|182975108|SUPERIORITY|||||||0.134|||||||Fisher Exact|||||||0.134
91547377|NCT01566695|182975109|SUPERIORITY|||||||0.324|||||||Fisher Exact|||||||0.324
91547378|NCT01566695|182975110|SUPERIORITY|||||||0.442|||||||Fisher Exact|||||||0.442
91547379|NCT01566695|182975111|SUPERIORITY|||||||0.063|||||||Fisher Exact|||||||0.063
91547380|NCT01566695|182975112|SUPERIORITY|||||||0.198|||||||Fisher Exact|||||||0.198
91547381|NCT01566695|182975113|SUPERIORITY|||||||0.972|||||||Fisher Exact|||||||0.972
91547382|NCT01566695|182975114|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
91547383|NCT01566695|182975115|SUPERIORITY|||||||0.07|||||||Fisher Exact|||||||0.070
91547384|NCT01566695|182975116|SUPERIORITY|||||||0.436|||||||Fisher Exact|||||||0.436
91547385|NCT01566695|182975117|SUPERIORITY|||||||0.683|||||||Fisher Exact|||||||0.683
91547386|NCT05956002|182975137|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.66|||||TWO_SIDED|90.0|91.33|98.12|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.12|91.33|
91547387|NCT05956002|182975137|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.96|||||TWO_SIDED|90.0|91.69|98.34|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.34|91.69|
91547388|NCT05956002|182975137|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.86|||||TWO_SIDED|90.0|82.9|88.92|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.92|82.90|
91547389|NCT05956002|182975137|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.24|||||TWO_SIDED|90.0|89.76|96.84|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||96.84|89.76|
91547390|NCT05956002|182975138|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.36|||||TWO_SIDED|90.0|90.97|97.89|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.89|90.97|
91765606|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.1102|||TWO_SIDED|95.0|-0.178|0.268|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours|||0.268|-0.178|
91765607|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.096|STANDARD_ERROR_OF_MEAN|0.0985|||TWO_SIDED|95.0|-0.103|0.295|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours|||0.295|-0.103|
91547391|NCT05956002|182975138|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.75|||||TWO_SIDED|90.0|91.41|98.2|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.20|91.41|
91547392|NCT05956002|182975138|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.44|||||TWO_SIDED|90.0|82.43|88.55|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.55|82.43|
91547393|NCT05956002|182975138|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.28|||||TWO_SIDED|90.0|89.61|97.1|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.10|89.61|
91547394|NCT05956002|182975139|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.7|||||TWO_SIDED|90.0|90.38|99.22|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||99.22|90.38|
91547395|NCT05956002|182975139|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.72|||||TWO_SIDED|90.0|88.59|97.04|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.04|88.59|
91547396|NCT05956002|182975139|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|87.24|||||TWO_SIDED|90.0|83.35|91.31|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||91.31|83.35|
91547397|NCT05956002|182975139|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.59|||||TWO_SIDED|90.0|88.24|97.17|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.17|88.24|
91547398|NCT04784559|182975150|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8751|TWO_SIDED|95.0|0.727|1.53||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors,|Plitidepsin 2.5 mg arm versus Control arm||1.53|0.727|0.8751
91547399|NCT04784559|182975150|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.0625|TWO_SIDED|95.0|0.96|1.96||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.96|0.960|0.0625
91547400|NCT04784559|182975151|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.5945|TWO_SIDED|95.0|0.655|1.37||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||1.37|0.655|0.5945
91765608|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.0826|||TWO_SIDED|95.0|-0.121|0.212|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours|||0.212|-0.121|
91765609|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.141|0.196|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours|||0.196|-0.141|
91765610|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0888|||TWO_SIDED|95.0|-0.138|0.221|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours|||0.221|-0.138|
91765611|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0934|||TWO_SIDED|95.0|-0.215|0.162|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour|||0.162|-0.215|
91765612|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.076|0.354|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours|||0.354|-0.076|
91765613|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.149|STANDARD_ERROR_OF_MEAN|0.0955|||TWO_SIDED|95.0|-0.044|0.342|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours|||0.342|-0.044|
91547401|NCT04784559|182975151|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3358|TWO_SIDED|95.0|0.827|1.7||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.70|0.827|0.3358
91547402|NCT04784559|182975152|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7252|TWO_SIDED|95.0|0.604|2.06||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||2.06|0.604|0.7252
91547403|NCT04784559|182975152|SUPERIORITY||Odds Ratio (OR)|1.69||||0.091|TWO_SIDED|95.0|0.92|3.11||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||3.11|0.920|0.0910
91547404|NCT03665597|182975163|OTHER|Geometric Least-Square Mean Ratio (GMR) = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.73|||||TWO_SIDED|90.0|0.68|0.78||||||||0.78|0.68|
91547405|NCT03665597|182975163|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.69|||||TWO_SIDED|90.0|0.64|0.74||||||||0.74|0.64|
91547406|NCT03665597|182975164|OTHER|GMR = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.4|||||TWO_SIDED|90.0|0.36|0.44||||||||0.44|0.36|
91547407|NCT03665597|182975164|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.41||||||||0.41|0.34|
91547408|NCT03811366|182975262|OTHER||||||<|0.001||||||significance when p\<0;05|generalized estimated equation|generalized estimated equation with normal distribution and logarithmic link function||||||<0.001
91547409|NCT03811366|182975265|OTHER|||||||0.054||||||significance when p\<0.05|Fisher Exact|||Recurrence or worsening of cells in anterior chamber in ERG-stable and ERG worsening group.||||0.054
91547410|NCT03811366|182975266|OTHER|||||||0.478||||||17 eyes presented dark dots fluctuation during follow up in stable ERG group when compared to 5 eyes in worsening ERG group.|generalized estimated equation|Generalized estimated equation with Poisson distribution and identity link function supposing an interchangeable correlation matrix between the eyes||||||0.478
91547411|NCT03811366|182975268|OTHER|9 (52.9%) eyes in ERG stable group x 4 (57.1%)eyes presented change in perivascular leakage during follow up (p=0.936).||||||0.936|||||||Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||Change in perivascular leakage in ERG-stable and ERG- worsening groups.||||0.936
91547412|NCT03811366|182975269|OTHER|||||||0.853||||||significance when p\<0.05|Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||||||0.853
91547413|NCT03811366|182975270|OTHER|||||||0.272||||||significance when p\<0.05|Fisher Exact|||||||0.272
91547414|NCT03811366|182975271|OTHER|||||||0.983||||||significance when p\<0.05|Generalized estimated equation with bino|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes||||||0.983
91547415|NCT02520063|182975282|OTHER||||||||||||||||||The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was be estimated at the end of the study along with two-sided 95% exact CIs (Clopper-Pearson intervals).|||
91547416|NCT04521478|182975315|OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.2||0.7636|TWO_SIDED|90.0|-3.0|4.3|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.3|-3.0|0.7636
91547417|NCT04521478|182975315|OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|2.2||0.304|TWO_SIDED|90.0|-1.4|5.9|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.9|-1.4|0.3040
91547418|NCT04521478|182975315|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.2||0.309|TWO_SIDED|90.0|-1.4|5.7|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.7|-1.4|0.3090
91547419|NCT04521478|182975315|OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.3694|TWO_SIDED|90.0|-1.3|4.4|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.4|-1.3|0.3694
91765614|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1005|||TWO_SIDED|95.0|-0.119|0.288|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours|||0.288|-0.119|
91765615|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.212|STANDARD_ERROR_OF_MEAN|0.1122|||TWO_SIDED|95.0|-0.015|0.438|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours|||0.438|-0.015|
91547420|NCT04521478|182975315|OTHER|||||||0.9158|||||||MCPMod Linear model|No parameter assumptions required. Corresponding dose response is linear||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9158
91765616|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.1051|||TWO_SIDED|95.0|-0.051|0.374|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours|||0.374|-0.051|
91765617|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1181|||TWO_SIDED|95.0|-0.017|0.461|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour|||0.461|-0.017|
91765618|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|-0.089|0.458|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours|||0.458|-0.089|
91547421|NCT04521478|182975315|OTHER|||||||0.8676|||||||MCPMod Exponential model|Assumption: 5% of the maximum effect is achieved at 25 mg; corresponding to a drug effect achieved mainly at higher doses||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.8676
91547422|NCT04521478|182975315|OTHER|||||||0.9552|||||||MCPMod Emax1 model|Assumption: 50% of the maximum effect is achieved at 25 mg; corresponding to the assumed true median effective dose (ED50) = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9552
91547423|NCT04521478|182975315|OTHER|||||||0.9619|||||||MCPMod Emax2 model|Assumption: 70% of the maximum effect is achieved at 5 mg; corresponding to a drug effect achieved mainly with low doses, ED50 = 2.14 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9619
91547424|NCT04521478|182975315|OTHER|||||||0.9507|||||||MCPMod Sigmoid Emax model|Assumption: 50% of the maximum effect is achieved at 25 mg, 90% 75 mg; corresponding to a more flexible model of the assumed true ED50 = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9507
91547425|NCT04521478|182975316|OTHER||Odds Ratio (OR)|0.9427||||0.8889|TWO_SIDED|90.0|0.4709|1.8873|||Regression, Logistic||5 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.8873|0.4709|0.8889
91547426|NCT04521478|182975316|OTHER||Odds Ratio (OR)|0.6581||||0.3284|TWO_SIDED|90.0|0.3255|1.3307|||Regression, Logistic||25 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.3307|0.3255|0.3284
91547427|NCT04521478|182975316|OTHER||Odds Ratio (OR)|1.1026||||0.8048|TWO_SIDED|90.0|0.5757|2.1114|||Regression, Logistic||75 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||2.1114|0.5757|0.8048
91547428|NCT04521478|182975316|OTHER||Odds Ratio (OR)|1.0072||||0.982|TWO_SIDED|90.0|0.5968|1.6999|||Regression, Logistic||125 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.6999|0.5968|0.9820
91765619|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.1187|||TWO_SIDED|95.0|0.007|0.487|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours|||0.487|0.007|
91765620|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.021|0.509|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours|||0.509|-0.021|
91765621|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1189|||TWO_SIDED|95.0|-0.086|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours|||0.394|-0.086|
91765622|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.1085|||TWO_SIDED|95.0|-0.044|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours|||0.394|-0.044|
91765623|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.1024|||TWO_SIDED|95.0|-0.122|0.292|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours|||0.292|-0.122|
91765624|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.1125|||TWO_SIDED|95.0|-0.155|0.3|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes|||0.300|-0.155|
91765625|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|-0.213|0.314|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes|||0.314|-0.213|
91765626|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.1572|||TWO_SIDED|95.0|-0.176|0.461|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes|||0.461|-0.176|
91765627|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-0.208|0.396|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes|||0.396|-0.208|
91765628|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.1332|||TWO_SIDED|95.0|-0.212|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes|||0.327|-0.212|
91765629|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.224|0.354|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes|||0.354|-0.224|
91547429|NCT04521478|182975317|OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.6||0.1013|TWO_SIDED|90.0|0.0|8.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.6|0.0|0.1013
91547430|NCT04521478|182975317|OTHER||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3596|TWO_SIDED|90.0|-1.9|6.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.6|-1.9|0.3596
91547431|NCT04521478|182975317|OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.6745|TWO_SIDED|90.0|-5.2|3.1|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||3.1|-5.2|0.6745
91547432|NCT04521478|182975317|OTHER||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.0||0.187|TWO_SIDED|90.0|-0.7|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.7|0.1870
91547433|NCT04521478|182975317|OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.0921|TWO_SIDED|90.0|0.1|8.1|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.1|0.1|0.0921
91547434|NCT04521478|182975317|OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.4||0.7395|TWO_SIDED|90.0|-3.2|4.8|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.8|-3.2|0.7395
91547435|NCT04521478|182975317|OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|2.4||0.6296|TWO_SIDED|90.0|-2.7|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-2.7|0.6296
91547436|NCT04521478|182975317|OTHER||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|1.9||0.0429|TWO_SIDED|90.0|0.7|6.9|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.9|0.7|0.0429
91547437|NCT04521478|182975318|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6211|TWO_SIDED|90.0|-0.3|0.5|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.5|-0.3|0.6211
91547438|NCT04521478|182975318|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.5158|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.5158
91547439|NCT04521478|182975318|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4518|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.4518
91765630|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.1283|||TWO_SIDED|95.0|-0.276|0.243|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour|||0.243|-0.276|
91765631|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.1118|||TWO_SIDED|95.0|-0.209|0.244|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours|||0.244|-0.209|
91547440|NCT04521478|182975318|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2347|TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.1|0.2347
91547441|NCT04521478|182975319|OTHER||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.1723|TWO_SIDED|90.0|-0.7|7.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||7.6|-0.7|0.1723
91547442|NCT04521478|182975319|OTHER||Mean Difference (Net)|4.4|STANDARD_ERROR_OF_MEAN|2.5||0.0757|TWO_SIDED|90.0|0.3|8.5|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.5|0.3|0.0757
91547443|NCT04521478|182975319|OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.4||0.6864|TWO_SIDED|90.0|-3.0|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-3.0|0.6864
91547444|NCT04521478|182975319|OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.1585|TWO_SIDED|90.0|-0.5|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.5|0.1585
91547445|NCT05902793|182975331|NON_INFERIORITY|the non-inferiority margin is 20%|least square means difference|0.89|||||TWO_SIDED|95.0|-14.3|16.07|||||To establish non-inferiority the lower limit of the least square mean difference had to be \> -20%.|||16.07|-14.30|
91547446|NCT05902793|182975333|SUPERIORITY|||||||0.24|||||||ANCOVA|ANCOVA model had fixed effects of treatment arm, center and wound size||||||0.24
91765632|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.35|0.053|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours|||0.053|-0.350|
91547447|NCT03328702|182975389|SUPERIORITY|Repeated measures ANOVA|Mean Difference (Net)|0.01|||<|0.05|TWO_SIDED|||||Repeated measures ANOVA, N=4|ANOVA|Repeated measures ANOVA||The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAP||||<0.05
91547448|NCT04674358|182975414|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|1.67|4.14||||||||4.14|1.67|
91547449|NCT03703700|182975416|OTHER||Risk Ratio (RR)|1.23||||0.042|TWO_SIDED|95.0|1.01|1.5|||Chi-squared|||||1.50|1.01|0.042
91547450|NCT03703700|182975417|OTHER|||||||0.781|||||||Wilcoxon (Mann-Whitney)|||||||0.781
91547451|NCT03703700|182975418|OTHER|||||||0.609|||||||Wilcoxon (Mann-Whitney)|||||||0.609
91547452|NCT03703700|182975419|OTHER|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||||||0.528
91547453|NCT03703700|182975420|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.880
91547454|NCT03703700|182975421|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
91547455|NCT03703700|182975422|OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
91547456|NCT03703700|182975423|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||||||0.163
91547457|NCT03703700|182975424|OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||||||0.197
91547458|NCT03703700|182975425|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||||||0.178
91547459|NCT03703700|182975426|OTHER|||||||0.549|||||||Wilcoxon (Mann-Whitney)|||||||0.549
91547460|NCT03703700|182975427|OTHER||Risk Ratio (RR)|1.19||||0.035|TWO_SIDED|95.0|1.01|1.4|||Chi-squared|||||1.40|1.01|0.035
91547461|NCT03703700|182975428|OTHER||Risk Ratio (RR)|1.18||||0.034|TWO_SIDED|95.0|1.01|1.37|||Chi-squared|||||1.37|1.01|0.034
91547462|NCT03703700|182975429|OTHER||Risk Ratio (RR)|1.22||||0.022|TWO_SIDED|95.0|1.03|1.45|||Chi-squared|||||1.45|1.03|0.022
91547463|NCT03703700|182975430|OTHER||Risk Ratio (RR)|0.94||||0.707|TWO_SIDED|95.0|0.68|1.3|||Chi-squared|||||1.30|0.68|0.707
91765633|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|95.0|-0.253|0.082|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours|||0.082|-0.253|
91547464|NCT03703700|182975431|OTHER||Risk Ratio (RR)|0.97||||0.878|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.878
91547465|NCT03703700|182975432|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.564
91547466|NCT03703700|182975432|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.417
91547467|NCT03703700|182975433|OTHER|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.985
91547468|NCT03703700|182975433|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.157
91547469|NCT03703700|182975434|OTHER||Risk Ratio (RR)|1.07||||0.789|TWO_SIDED|95.0|0.65|1.78|||Chi-squared|||||1.78|0.65|0.789
91547470|NCT03703700|182975435|OTHER||Risk Ratio (RR)|1.09||||0.769|TWO_SIDED|95.0|0.61|1.94|||Chi-squared|||||1.94|0.61|0.769
91547471|NCT03703700|182975436|OTHER||Risk Ratio (RR)|0.41||||0.59|TWO_SIDED|95.0|0.04|4.45|||Fisher Exact|||||4.45|0.04|0.590
91547472|NCT03703700|182975437|OTHER||Risk Ratio (RR)|2.04||||0.465|TWO_SIDED|95.0|0.4|10.39|||Fisher Exact|||||10.39|0.40|0.465
91547473|NCT03988634|182975487|SUPERIORITY||Geometric Mean Ratio|0.8546||||0.0492|TWO_SIDED|95.0|0.7307|0.9994|||ANCOVA||Geometric Mean Ratio: sac/val vs valsartan|||0.9994|0.7307|0.0492
91765634|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.0843|||TWO_SIDED|95.0|-0.211|0.13|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours|||0.130|-0.211|
91765635|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.161|0.202|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours|||0.202|-0.161|
91765636|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.196|0.186|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour|||0.186|-0.196|
91547474|NCT03988634|182975488|SUPERIORITY||Win Ratio|1.193||||0.1578|TWO_SIDED|95.0|0.934|1.524|||unmatched pairwise win-ratio||A win ratio greater than 1 was in favor of sacubitril/valsartan arm|||1.524|0.934|0.1578
91547475|NCT03988634|182975489|SUPERIORITY||rate ratio|0.8346||||0.3563|TWO_SIDED|95.0|0.5684|1.2255|||LWYY model||A rate ratio \< 1 indicates an effect in favor of LCZ696|||1.2255|0.5684|0.3563
91547476|NCT03988634|182975490|SUPERIORITY||Rate ratio|0.6249||||0.3155|TWO_SIDED|95.0|0.2496|1.5649|||negative binomial regression model|||||1.5649|0.2496|0.3155
91547477|NCT03988634|182975491|SUPERIORITY||ratio of the change|0.9316||||0.4766|TWO_SIDED|95.0|0.7661|1.1329|||ANCOVA|||||1.1329|0.7661|0.4766
91547478|NCT03988634|182975492|SUPERIORITY||ratio of the change|0.8268|||<|0.0001|TWO_SIDED|95.0|0.76|0.91|||ANCOVA|||Week 4||0.91|0.76|<.0001
91547479|NCT03988634|182975492|SUPERIORITY||ratio of the change|0.8103|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||ANCOVA|||Week 8||0.89|0.74|<.0001
91547480|NCT03205800|182975510|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
91547481|NCT01007591|182975547|SUPERIORITY||Mean Difference (Final Values)|-6.02||||0.75|TWO_SIDED|95.0|-43.7|31.7|||ANOVA|Treatment comparison using an ANOVA model with age group and treatment as design variables.||||31.7|-43.7|0.75
91765637|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|-0.105|0.33|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours|||0.330|-0.105|
91547482|NCT04083235|182975552|OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Stratified log-rank test||The HR and 95% confidence interval (CI) was based on a stratified Cox proportional hazards regression model, stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status, region and liver metastases as per IWRS.|||0.99|0.70|0.04
91547483|NCT04083235|182975553|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.83|||Stratified log-rank test||The HR and 95% CI was based on a stratified Cox proportional hazards regression model, stratified by baseline ECOG performance status, region and liver metastases as per IWRS.|||0.83|0.58|<0.0001
91547484|NCT04083235|182975554|OTHER||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.69|||Cochran-Mantel-Haenszel||OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.|||1.69|0.95|0.11
91547485|NCT04088630|182975569|SUPERIORITY|||||||0.0427||||||p\<0.05 considered significant. Between group pairwise comparisons performed with Bonferroni correction.|Fisher Exact|||Difference in proportion of subjects with cardiac events up to 30 days post-ictus tested between three groups.||||0.0427
91547486|NCT04088630|182975570|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Difference in proportion of subjects with nosocomial infections up to 90 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.19
91547487|NCT04088630|182975571|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Difference in proportion of subjects with neurologic decline up to 30 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.30
91547488|NCT03381261|182975588|OTHER|While descriptive statistics were presented in the original mRNA units using median and interquartile range (25th, 75th), statistical group comparison and effect sizes were reported as the ratio of the geometric means.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91547489|NCT05634226|182975589|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
91547490|NCT05634226|182975590|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
91547491|NCT05324124|182975622|OTHER||Ratio of Geometric Least Squares Mean|0.952|||||TWO_SIDED|90.0|0.876|1.03||||||||1.03|0.876|
91547492|NCT05324124|182975623|OTHER||Ratio of Geometric Least Squares Mean|0.949|||||TWO_SIDED|90.0|0.869|1.04||||||||1.04|0.869|
91547493|NCT05324124|182975624|OTHER||Ratio of Geometric Least Squares Mean|0.829|||||TWO_SIDED|90.0|0.744|0.925||||||||0.925|0.744|
91765638|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.0968|||TWO_SIDED|95.0|-0.065|0.326|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours|||0.326|-0.065|
91765639|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|-0.213|0.199|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours|||0.199|-0.213|
91765640|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.1138|||TWO_SIDED|95.0|-0.052|0.407|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours|||0.407|-0.052|
91765641|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.135|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.08|0.351|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours|||0.351|-0.080|
91765642|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|95.0|-0.062|0.421|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour|||0.421|-0.062|
91765643|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.146|STANDARD_ERROR_OF_MEAN|0.1373|||TWO_SIDED|95.0|-0.131|0.423|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours|||0.423|-0.131|
91765644|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1203|||TWO_SIDED|95.0|-0.075|0.411|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours|||0.411|-0.075|
91547494|NCT03761537|182975659|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.018|TWO_SIDED|95.0|2.5|25.7||This endpoint was the first endpoint in the sequential testing hierarchy.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.7|2.5|0.018
91547495|NCT03761537|182975660|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|9.7||||0.106|TWO_SIDED|95.0|-2.0|21.4||This endpoint was the second endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||21.4|-2.0|0.106
91547496|NCT03761537|182975661|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.6|||<|0.001|TWO_SIDED|95.0|-13.0|-4.2||This was the third endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline SCORAD interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.2|-13.0|<0.001
91547497|NCT03761537|182975662|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.5||||0.009|TWO_SIDED|95.0|-2.6|-0.4||This was the fourth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline DLQI interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.4|-2.6|0.009
91547498|NCT03761537|182975663|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|15.6||||0.005|TWO_SIDED|95.0|4.8|26.3||This endpoint was the fifth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||26.3|4.8|0.005
91547499|NCT03761537|182975664|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.014|TWO_SIDED|95.0|2.9|25.3||This endpoint was the sixth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.3|2.9|0.014
91547500|NCT03761537|182975665|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|7.3||||0.228|TWO_SIDED|95.0|-4.6|19.2||This endpoint was the seventh endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|HaenszMantelel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||19.2|-4.6|0.228
91765645|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|95.0|-0.047|0.49|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours|||0.490|-0.047|
91765646|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.143|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|-0.1|0.387|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours|||0.387|-0.100|
91765647|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.035|0.41|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours|||0.410|-0.035|
91547501|NCT03761537|182975666|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.9|||<|0.001|TWO_SIDED|95.0|-13.2|-4.6||This endpoint was the eighth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline SCORAD in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.6|-13.2|<0.001
91547502|NCT03761537|182975667|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.6||||0.005|TWO_SIDED|95.0|-2.7|-0.5||This endpoint was the ninth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline DLQI in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.5|-2.7|0.005
91547503|NCT03761537|182975668|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.3||||0.014|TWO_SIDED|95.0|2.9|25.6||This endpoint was the tenth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.6|2.9|0.014
91547504|NCT03892616|182975716|OTHER||Ratio of adjusted geometric means [%]|97.4|||||TWO_SIDED|90.0|82.3|115.3|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||115.3|82.3|
91547505|NCT03892616|182975716|OTHER||Ratio of adjusted geometric means [%]|183.0|||||TWO_SIDED|90.0|154.0|217.4|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||217.4|154.0|
91547506|NCT03892616|182975716|OTHER||Ratio of adjusted geometric means [%]|114.8|||||TWO_SIDED|90.0|96.5|136.6|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||136.6|96.5|
91547507|NCT03892616|182975716|OTHER||Ratio of adjusted geometric means [%]|66.5|||||TWO_SIDED|90.0|55.5|79.5|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||79.5|55.5|
91547508|NCT03892616|182975717|OTHER||Ratio of adjusted geometric means [%]|60.2|||||TWO_SIDED|90.0|55.3|65.5|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.5|55.3|
91547509|NCT03892616|182975717|OTHER||Ratio of adjusted geometric means [%]|71.5|||||TWO_SIDED|90.0|65.6|78.0|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||78.0|65.6|
91547510|NCT03892616|182975717|OTHER||Ratio of adjusted geometric means [%]|177.9|||||TWO_SIDED|90.0|162.8|194.3|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||194.3|162.8|
91547511|NCT03892616|182975717|OTHER||Ratio of adjusted geometric means [%]|152.9|||||TWO_SIDED|90.0|139.5|167.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||167.7|139.5|
91547512|NCT03892616|182975718|OTHER||Ratio of adjusted geometric means [%]|60.3|||||TWO_SIDED|90.0|55.4|65.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.7|55.4|
91547513|NCT03892616|182975718|OTHER||Ratio of adjusted geometric means [%]|71.1|||||TWO_SIDED|90.0|65.2|77.6|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.6|65.2|
91547514|NCT03892616|182975718|OTHER||Ratio of adjusted geometric means [%]|175.8|||||TWO_SIDED|90.0|160.8|192.2|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||192.2|160.8|
91547515|NCT03892616|182975718|OTHER||Ratio of adjusted geometric means [%]|150.2|||||TWO_SIDED|90.0|136.9|164.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||164.7|136.9|
91547516|NCT03892616|182975719|OTHER||Ratio of adjusted geometric means [%]|56.5|||||TWO_SIDED|90.0|51.8|61.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||61.7|51.8|
91547517|NCT03892616|182975719|OTHER||Ratio of adjusted geometric means [%]|70.5|||||TWO_SIDED|90.0|64.4|77.1|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.1|64.4|
91547518|NCT03892616|182975719|OTHER||Ratio of adjusted geometric means [%]|185.3|||||TWO_SIDED|90.0|169.4|202.8|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||202.8|169.4|
91547519|NCT03892616|182975719|OTHER||Ratio of adjusted geometric means [%]|158.4|||||TWO_SIDED|90.0|144.3|173.9|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||173.9|144.3|
91547520|NCT03683719|182975720|SUPERIORITY||||||<|0.001||||||"P-values were adjusted for multiple comparisons. Models with an adjusted p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.||||<0.001
91547521|NCT03683719|182975720|SUPERIORITY||Risk Difference (RD)|13.29|||>|0.05|TWO_SIDED|95.0|0.34|26.24||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||26.24|0.34|>0.05
91547522|NCT03683719|182975720|SUPERIORITY||Risk Difference (RD)|-0.03|||>|0.05|TWO_SIDED|95.0|-10.44|10.39||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||10.39|-10.44|>0.05
91765648|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1039|||TWO_SIDED|95.0|-0.042|0.378|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours|||0.378|-0.042|
91547523|NCT03683719|182975720|SUPERIORITY||Risk Difference (RD)|28.22|||<|0.001|TWO_SIDED|95.0|13.8|42.64||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||42.64|13.8|<0.001
91547524|NCT03683719|182975720|SUPERIORITY||Risk Difference (RD)|29.61|||<|0.001|TWO_SIDED|95.0|14.56|44.67||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||44.67|14.56|<0.001
91547525|NCT03683719|182975721|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with an adj. p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||"The secondary endpoint Change from baseline to Week 16 in HECSI score was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve."||||<0.0001
91547526|NCT03683719|182975721|SUPERIORITY||Mean Difference (Net)|-13.41|||<|0.01|TWO_SIDED|95.0|-22.82|-4.01||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-4.01|-22.82|<0.01
91547527|NCT03683719|182975721|SUPERIORITY||Mean Difference (Net)|-9.53|||<|0.05|TWO_SIDED|95.0|-19.04|-0.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-0.02|-19.04|<0.05
91547528|NCT03683719|182975721|SUPERIORITY||Mean Difference (Net)|-20.29|||<|0.0001|TWO_SIDED|95.0|-29.56|-11.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-11.02|-29.56|<0.0001
91547529|NCT03683719|182975721|SUPERIORITY||Mean Difference (Net)|-15.59|||<|0.01|TWO_SIDED|95.0|-24.82|-6.36||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-6.36|-24.82|<0.01
91547530|NCT03683719|182975722|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.05||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.05
91765649|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.221|STANDARD_ERROR_OF_MEAN|0.1036|||TWO_SIDED|95.0|0.011|0.431|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes|||0.431|0.011|
91765650|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1236|||TWO_SIDED|95.0|-0.006|0.494|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes|||0.494|-0.006|
91765651|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.255|STANDARD_ERROR_OF_MEAN|0.1445|||TWO_SIDED|95.0|-0.038|0.548|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes|||0.548|-0.038|
91547531|NCT03683719|182975722|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||>|0.1||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||>0.1
91765652|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.233|STANDARD_ERROR_OF_MEAN|0.1436|||TWO_SIDED|95.0|-0.057|0.524|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes|||0.524|-0.057|
91765653|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.219|STANDARD_ERROR_OF_MEAN|0.1262|||TWO_SIDED|95.0|-0.036|0.474|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes|||0.474|-0.036|
91765654|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.294|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|0.019|0.568|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes|||0.568|0.019|
91765655|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.227|STANDARD_ERROR_OF_MEAN|0.1216|||TWO_SIDED|95.0|-0.019|0.473|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour|||0.473|-0.019|
91765656|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1059|||TWO_SIDED|95.0|-0.01|0.418|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours|||0.418|-0.010|
91765657|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.075|0.308|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours|||0.308|-0.075|
91765658|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0805|||TWO_SIDED|95.0|-0.136|0.19|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours|||0.190|-0.136|
91765659|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|-0.116|0.208|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours|||0.208|-0.116|
91765660|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|STANDARD_ERROR_OF_MEAN|0.0855|||TWO_SIDED|95.0|-0.099|0.247|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour|||0.247|-0.099|
91765661|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.051|0.313|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours|||0.313|-0.051|
91765662|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|-0.004|0.411|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours|||0.411|-0.004|
91765663|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.181|STANDARD_ERROR_OF_MEAN|0.0918|||TWO_SIDED|95.0|-0.004|0.367|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours|||0.367|-0.004|
91765664|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.0967|||TWO_SIDED|95.0|-0.018|0.373|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours|||0.373|-0.018|
91765665|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.288|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|0.07|0.506|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours|||0.506|0.070|
91765666|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.283|STANDARD_ERROR_OF_MEAN|0.1011|||TWO_SIDED|95.0|0.079|0.488|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours|||0.488|0.079|
91765667|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.386|STANDARD_ERROR_OF_MEAN|0.1137|||TWO_SIDED|95.0|0.157|0.616|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour|||0.616|0.157|
91765668|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.1306|||TWO_SIDED|95.0|0.108|0.636|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours|||0.636|0.108|
91765669|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.458|STANDARD_ERROR_OF_MEAN|0.1142|||TWO_SIDED|95.0|0.227|0.688|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours|||0.688|0.227|
91765670|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.509|STANDARD_ERROR_OF_MEAN|0.1264|||TWO_SIDED|95.0|0.254|0.765|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours|||0.765|0.254|
91765671|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.492|STANDARD_ERROR_OF_MEAN|0.1144|||TWO_SIDED|95.0|0.261|0.723|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours|||0.723|0.261|
91765672|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.414|STANDARD_ERROR_OF_MEAN|0.1042|||TWO_SIDED|95.0|0.203|0.625|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours|||0.625|0.203|
91765673|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|0.241|0.639|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours|||0.639|0.241|
91765674|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|0.135|0.562|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes|||0.562|0.135|
91765675|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.494|STANDARD_ERROR_OF_MEAN|0.1273|||TWO_SIDED|95.0|0.237|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes|||0.751|0.237|
91765676|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.499|STANDARD_ERROR_OF_MEAN|0.1484|||TWO_SIDED|95.0|0.199|0.8|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes|||0.800|0.199|
91765677|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.274|0.872|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes|||0.872|0.274|
91765678|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.488|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|0.225|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes|||0.751|0.225|
91765679|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.1398|||TWO_SIDED|95.0|0.098|0.663|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes|||0.663|0.098|
91765680|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.342|STANDARD_ERROR_OF_MEAN|0.1254|||TWO_SIDED|95.0|0.089|0.596|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour|||0.596|0.089|
91547532|NCT03683719|182975722|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.0001||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.0001
91547533|NCT03683719|182975722|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.01||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.01
91547534|NCT05081583|182975723|OTHER||AUC ratio (geometric mean)|0.88|||||TWO_SIDED|90.0|0.82|0.96||||||The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.||0.96|0.82|
91547535|NCT05081583|182975724|OTHER|The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.|Cmax ratio (geometric mean)|0.93|||||TWO_SIDED|90.0|0.85|1.01||||||||1.01|0.85|
91547536|NCT05081583|182975725|OTHER||Half-life ratio (geometric mean)|1.01|||||TWO_SIDED|90.0|0.93|1.07||||||||1.07|0.93|
91547537|NCT05081583|182975726|OTHER||Renal clearance ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.84|1.12||||||||1.12|0.84|
91547538|NCT05081583|182975727|OTHER||AUC ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.81|1.15||||||||1.15|0.81|
91547539|NCT03924986|182975738|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.73|0.38|
91547540|NCT03924986|182975739|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.11|3.07|||||||Arm B was the reference group, and the odds ratio between arms was calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by gender and liver metastases status.|3.07|1.11|
91547541|NCT03924986|182975741|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.05|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|||1.05|0.51|
91765681|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.218|STANDARD_ERROR_OF_MEAN|0.1094|||TWO_SIDED|95.0|-0.003|0.439|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours|||0.439|-0.003|
91547542|NCT03924986|182975742|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.76|0.38|
91547543|NCT05516147|182975782|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.|t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.||||<.01
91765682|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.0974||||95.0|-0.07|0.323|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours|||0.323|-0.070|
91765683|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0818|||TWO_SIDED|95.0|-0.107|0.223|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours|||0.223|-0.107|
91765684|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0821|||TWO_SIDED|95.0|-0.192|0.139|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours|||0.139|-0.192|
91547544|NCT05516147|182975783|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||||<.01
91547545|NCT05516147|182975784|SUPERIORITY|||||||0.06||||||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||||0.06
91547546|NCT05516147|182975785|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.||||<.01
91547547|NCT05516147|182975787|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||baseline score vs. post-treatment, paired sample t-test||||0.81
91547548|NCT05516147|182975788|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.20
91547549|NCT05516147|182975789|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.83
91547550|NCT05516147|182975790|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.320
91547551|NCT02815813|182975807|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
91547552|NCT02815813|182975808|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
91547553|NCT02187003|182975812|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7944|TWO_SIDED|95.0|0.77|1.22|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95 percent (%) confidence interval (CI). A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P value.||1.22|0.77|0.7944
91547554|NCT02187003|182975813|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7156|TWO_SIDED|95.0|0.77|1.19|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.19|0.77|0.7156
91547555|NCT02187003|182975814|SUPERIORITY||Mean Difference (Net)|-0.06||||0.852|TWO_SIDED|95.0|-1.27|0.88|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P-value was from analysis of covariance (ANCOVA) model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.88|-1.27|0.8520
91547556|NCT02187003|182975815|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8593|TWO_SIDED|95.0|0.82|1.26|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.26|0.82|0.8593
91547557|NCT02187003|182975816|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.9332|TWO_SIDED|95.0|-0.13|0.16|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P value was from ANCOVA model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.16|-0.13|0.9332
91547558|NCT02187003|182975817|SUPERIORITY||Difference in percentage of participants|-1.17||||0.5349|TWO_SIDED|95.0|-5.19|2.46|||Chan and Zhang|||P values and 95% CI for the difference in percentages were based on the exact method by Chan and Zhang.||2.46|-5.19|0.5349
91547559|NCT02187003|182975824|SUPERIORITY||Risk Difference (RD)|-3.336||||0.302|TWO_SIDED|95.0|-10.024|2.968|||Chan and Zhang|||||2.968|-10.024|0.3020
91547560|NCT02187003|182975825|SUPERIORITY||Risk Difference (RD)|1.203||||0.5429|TWO_SIDED|95.0|-2.379|5.104|||Chan and Zhang|||||5.104|-2.379|0.5429
91547561|NCT05063994|182975840|NON_INFERIORITY|Non-inferiority of Chronocort to Cortef was declared if the 95% CI for the difference in biochemical response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above minus 15 percentage points.|Treatment Difference|25.7|STANDARD_ERROR_OF_MEAN|11.82||0.0003|TWO_SIDED|95.0|2.5|48.9||One-sided non-inferiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||48.9|2.5|0.0003
91547562|NCT05063994|182975841|SUPERIORITY|Superiority of Chronocort to Cortef with respect to the dose response after 28 weeks of randomized treatment was declared if the two-sided 95% CI for the difference in response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above zero, provided that non-inferiority of Chronocort to Cortef with respect to the biochemical response had been declared under the primary efficacy objective.|Treatment Difference|25.3|STANDARD_ERROR_OF_MEAN|11.24||0.012|TWO_SIDED|95.0|3.3|47.3||One-sided superiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||47.3|3.3|0.012
91547563|NCT05063994|182975842|SUPERIORITY|Superiority of Chronocort to Cortef (with respect to the total daily dose after 28 weeks of randomized treatment) was declared if the two-sided 95% CI for the difference in means between the 2 treatment arms (Chronocort minus Cortef) was wholly below zero, provided that non-inferiority of Chronocort to Cortef in terms of biochemical response had been declared under the primary efficacy objective, and superiority of Chronocort to Cortef in terms of dose response has been declared.|Treatment Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|-9.2|-2.5||One-sided superiority.|MMRM|||||-2.5|-9.2|0.0005
91547564|NCT04490915|182975868|SUPERIORITY||LS Mean Difference|-17.022|STANDARD_ERROR_OF_MEAN|3.433|<|0.0001|TWO_SIDED|95.0|-23.802|-10.243|||ANCOVA||LS Mean Difference of Crinecerfont - Placebo|||-10.243|-23.802|<0.0001
91547565|NCT03149315|182975880|SUPERIORITY|Values for grouped data were reported as mean ± SD and were calculated using Graphpad Prism 7 software (La Jolla, CA), which was also used for generating figures and for statistical analyses. Changes in skin test area (wheal and flare) were analyzed at each time point (after 2 doses, 4 doses, etc) using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.|||||<|0.0001||||||The above p value reflects the statistical analysis of skin test area between baseline and 2 doses of ibrutinib.|Wilcoxon (Mann-Whitney)|Changes in skin test area at each time point were analyzed using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.||||||<0.0001
91547566|NCT03149315|182975881|SUPERIORITY|Changes in BAT were analyzed at each time point (after 2 doses, 4 doses, etc) using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs. A p value \< 0.05 was considered significant.|||||<|0.001||||||The above p value reflects the statistical analysis of BAT between baseline and 2 doses of ibrutinib.|ANOVA|Changes in BAT were analyzed at each time point using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs.||||||<0.001
91547567|NCT00667251|182975883|OTHER||Hazard Ratio (HR)|1.367||||0.001|TWO_SIDED|95.0|1.133|1.648|||Log Rank|||PFS at the time of Primary Analysis (IIT population)||1.648|1.133|0.0010
91547568|NCT00667251|182975883|OTHER||Hazard Ratio (HR)|1.484||||0.0002|TWO_SIDED|95.0|1.204|1.829|||Log Rank|||PFS at the time of Primary Analysis (Central HER2+ population)||1.829|1.204|0.0002
91547569|NCT00667251|182975884|OTHER||Hazard Ratio (HR)|1.3722|||||TWO_SIDED|95.0|1.1466|1.6422|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (IIT population)||1.6422|1.1466|
91765685|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|-0.085|0.268|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours|||0.268|-0.085|
91547570|NCT00667251|182975884|OTHER||Hazard Ratio (HR)|1.4968|||||TWO_SIDED|95.0|1.2251|1.8288|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (Central HER2+ population)||1.8288|1.2251|
91547571|NCT00667251|182975885|OTHER||Hazard Ratio (HR)|1.3786|||||TWO_SIDED|95.0|1.0246|1.8549|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (IIT population)||1.8549|1.0246|
91547572|NCT00667251|182975886|OTHER||Hazard Ratio (HR)|1.5818|||||TWO_SIDED|95.0|1.1181|2.2379|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (Central HER2+ population)||2.2379|1.1181|
91547573|NCT00667251|182975889|OTHER||Hazard Ratio (HR)|1.0916|||||TWO_SIDED|95.0|0.7271|1.6389|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (IIT population)||1.6389|0.7271|
91547574|NCT00667251|182975890|OTHER||Hazard Ratio (HR)|1.0951|||||TWO_SIDED|95.0|0.7144|1.6787|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (Central HER2+ population)||1.6787|0.7144|
91547575|NCT00667251|182975895|OTHER||Hazard Ratio (HR)|1.0091|||||TWO_SIDED|95.0|0.809|1.2586|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (IIT population)||1.2586|0.8090|
91547576|NCT00667251|182975896|OTHER||Hazard Ratio (HR)|0.9573|||||TWO_SIDED|95.0|0.7544|1.2148|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (Central HER2+ population)||1.2148|0.7544|
91547577|NCT00667251|182975897|OTHER||Hazard Ratio (HR)|1.4866|||||TWO_SIDED|95.0|1.1479|1.9251|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (IIT population)||1.9251|1.1479|
91547578|NCT00667251|182975898|OTHER||Hazard Ratio (HR)|1.5594|||||TWO_SIDED|95.0|1.1767|2.0666|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (Central HER2+ population)||2.0666|1.1767|
91547579|NCT05034952|182975911|SUPERIORITY|||||||0.3914|||||||ANCOVA|||||||0.3914
91547580|NCT05034952|182975911|SUPERIORITY|||||||0.1266|||||||ANCOVA|||||||0.1266
91547581|NCT05034952|182975911|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
91547582|NCT05034952|182975912|SUPERIORITY|||||||0.5476|||||||ANCOVA|||||||0.5476
91547583|NCT05034952|182975912|SUPERIORITY|||||||0.0825|||||||ANCOVA|||||||0.0825
91547584|NCT05034952|182975912|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
91547585|NCT05034952|182975913|SUPERIORITY|||||||0.4712|||||||Cochran-Mantel-Haenszel|||||||0.4712
91547586|NCT05034952|182975913|SUPERIORITY|||||||0.1635|||||||Cochran-Mantel-Haenszel|||||||0.1635
91547587|NCT05034952|182975913|SUPERIORITY|||||||0.1158|||||||Cochran-Mantel-Haenszel|||||||0.1158
91547588|NCT05034952|182975914|SUPERIORITY|||||||0.2882|||||||Cochran-Mantel-Haenszel|||||||0.2882
91547589|NCT05034952|182975914|SUPERIORITY|||||||0.2344|||||||Cochran-Mantel-Haenszel|||||||0.2344
91547590|NCT05034952|182975914|SUPERIORITY|||||||0.1724|||||||Cochran-Mantel-Haenszel|||||||0.1724
91547591|NCT05034952|182975915|SUPERIORITY|||||||0.1343|||||||Cochran-Mantel-Haenszel|||||||0.1343
91547592|NCT05034952|182975915|SUPERIORITY|||||||0.4501|||||||Cochran-Mantel-Haenszel|||||||0.4501
91547593|NCT05034952|182975915|SUPERIORITY|||||||0.1009|||||||Cochran-Mantel-Haenszel|||||||0.1009
91547594|NCT02437318|182975917|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.00065|TWO_SIDED|95.0|0.5|0.85||(one-sided)|Log Rank|||||0.85|0.50|0.00065
91547595|NCT06074523|182975946|EQUIVALENCE|Comparing three conditions in a basic science experiment in healthy adults.|partial eta squared|0.81|||<|0.001|TWO_SIDED||||||ANOVA|||Comparing Cued Suppression Task; Positive, Negative, and Neutral Cue condtions||||<.001
91547596|NCT06074523|182975947|EQUIVALENCE|P\<.05 criterion|cohen's d|0.24||||0.08|TWO_SIDED||||||t-test, 2 sided|||Comparing performance on target absent and target present trials||||.08
91547597|NCT06074523|182975948|OTHER||Slope|-0.37||||0.007|TWO_SIDED|95.0|-0.5803|-0.1135|||correlation|||Relationship between Cued Attention Negative Cue Benefit (Neutral Cue RT- Negative Cue RT) and working memory capacity.||-0.1135|-0.5803|.007
91547598|NCT06074523|182975949|OTHER||Slope|-0.27||||0.046|TWO_SIDED|95.0|-0.5015|-0.002414|||correlation|||Correlation of Inattentive Traits subscale and learned suppression (difference in RT between target absent and target present trials)||-0.002414|-0.5015|.046
91547599|NCT02167867|182975979|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||t=+7.76||||<0.0001
91547600|NCT04382404|182975985|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.63|1.15|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Velpatasvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 449.39 (77.12).||1.15|0.63|
91547601|NCT04382404|182975986|OTHER||Geometric mean ratio|1.19|||||TWO_SIDED|90.0|0.88|1.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Sofosbuvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1226.16 (59.46).||1.60|0.88|
91547602|NCT04382404|182975987|OTHER||Geometric mean ratio|0.57|||||TWO_SIDED|90.0|0.49|0.67|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of GS-331007 in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1312.17 (32.55).||0.67|0.49|
91547603|NCT04382404|182975988|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.67|1.23|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Area under the plasma concentration versus time curve tau of Velpatasvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 3570.65 (72.04).||1.23|0.67|
91547604|NCT04382404|182975989|OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|1.06|1.78||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 1483.83 (66.43).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|1.78|1.06|
91547605|NCT04382404|182975990|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|90.0|0.55|0.71||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 15361.31 (22.35).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|0.71|0.55|
91547606|NCT04382404|182975991|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.91|2.25||||||The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|2.25|0.91|
91547607|NCT04382404|182975992|OTHER||Geometric mean ratio|1.91|||||TWO_SIDED|95.0|1.14|3.19|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||3.19|1.14|
91547608|NCT04382404|182975993|OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|95.0|0.87|2.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||2.60|0.87|
91547609|NCT04382404|182975994|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.5|0.56|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.56|.50|
91547610|NCT04382404|182975995|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.49|0.58|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.58|.49|
91547611|NCT04382404|182975996|OTHER||Geometric mean ratio|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.64|.48|
91547612|NCT03420833|182976019|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91547613|NCT03420833|182976019|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
91547614|NCT03420833|182976022|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
91547615|NCT03420833|182976024|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
91547616|NCT03420833|182976024|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
91547617|NCT05687916|182976028|SUPERIORITY||LS Mean Difference Estimate|-0.24|STANDARD_ERROR_OF_MEAN|3.277|=|0.989|TWO_SIDED|95.0|-6.67|6.18||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||6.18|-6.67|=0.989
91547618|NCT05687916|182976028|SUPERIORITY||LS Mean Difference Estimate|2.4|STANDARD_ERROR_OF_MEAN|3.227|=|0.916|TWO_SIDED|95.0|-3.93|8.72||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||8.72|-3.93|=0.916
91547619|NCT05687916|182976029|SUPERIORITY||LS Mean Difference Estimate|-0.32|STANDARD_ERROR_OF_MEAN|1.656|=|0.989|TWO_SIDED|95.0|-3.57|2.92||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||2.92|-3.57|=0.989
91765686|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.102|0.269|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour|||0.269|-0.102|
91547620|NCT05687916|182976029|SUPERIORITY||LS Mean Difference Estimate|-3.06|STANDARD_ERROR_OF_MEAN|1.59|=|0.216|TWO_SIDED|95.0|-6.18|0.06||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||0.06|-6.18|=0.216
91547621|NCT02907099|182976114|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
91547622|NCT02907099|182976115|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
91547623|NCT03519581|182976135|OTHER|The primary statistical analysis was an intention-to-treat analysis. The primary outcome was analyzed by Kruskal-Wallis test because the data was non-parametric.||||||0.76|||||||Kruskal-Wallis|||The target sample size for the study was 30 eyes, based on power calculations to achieve 80% power assuming 40% of sham-treated eyes will reach the vision loss threshold within 2 years, while SML treatment will reduce that value to 15%, using a 2:1 ratio for randomization (2 treatment : 1 sham).||||.76
91547624|NCT03519581|182976136|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.16
91547625|NCT03519581|182976137|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
91547626|NCT03519581|182976138|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||.68
91547627|NCT03519581|182976139|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
91547628|NCT03519581|182976140|SUPERIORITY|Two-tailed t-tests and mixed effects regression models||||||0.5|||||||t-test, 2 sided|||||||.50
91547629|NCT01781468|182976149|SUPERIORITY|||||||0.9601|||||||Fisher Exact|||||||0.9601
91547630|NCT01781468|182976150|SUPERIORITY|||||||0.7877|||||||Fisher Exact|||||||0.7877
91547631|NCT01781468|182976151|SUPERIORITY|||||||0.3272|||||||Kruskal-Wallis|||||||0.3272
91547632|NCT01781468|182976152|SUPERIORITY|||||||0.9122|||||||Kruskal-Wallis|||Baseline to Week 4||||0.9122
91547633|NCT01781468|182976152|SUPERIORITY|||||||0.8559|||||||Kruskal-Wallis|||Baseline to Week 8||||0.8559
91547634|NCT04410042|182976186|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4|||||||Wilcoxon rank sum test|||||||0.4000
91547635|NCT04410042|182976187|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4286|||||||Wilcoxon rank sum test|||||||0.4286
91547636|NCT04410042|182976188|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9307|||||||Wilcoxon rank sum test|||||||0.9307
91547637|NCT04410042|182976189|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.0714|||||||Wilcoxon rank sum test|||||||0.0714
91547638|NCT04410042|182976190|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9004|||||||Wilcoxon rank sum test|||||||0.9004
91547639|NCT05486078|182976214|OTHER|Repeated measures ANOVA||||||0.001|||||||ANOVA|||Hip abduction strength was analyzed using repeated measures ANOVA. The assumption of sphericity was tested and Bonferroni correction was applied for pairwise comparisons. A p-value \< 0.001 was considered statistically significant.||||0.001
91547640|NCT05486078|182976215|OTHER|McNemar Exact Test|||||<|0.0001||||||P-value derived from McNemar exact test comparing binary outcome (improved vs. unchanged). Statistical significance threshold set at p \< 0.05.|McNemar|McNemar Exact Test||MRI improvement was assessed using paired evaluation of inflammatory signs (edema) at baseline and Week 24. McNemar exact test was used for within-subject categorical comparison.||||< 0.0001
91547641|NCT05486078|182976216|OTHER|Friedman Test Within-group||||||0.992|||||||Friedman Test Within-group|||Analgesic use (units/week) was analyzed over time using the Friedman test for repeated measures. No significant variation across follow-up visits was found.||||0.992
91547642|NCT03978871|182976223|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<0.001
91547643|NCT03978871|182976224|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.023|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.023
91547644|NCT03978871|182976224|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.034|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.034
91547645|NCT03978871|182976225|SUPERIORITY|The threshold for statistical significance was p = 0.0.5|||||<|0.001|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<.001
91547646|NCT03978871|182976225|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.002|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.002
91547647|NCT03978871|182976226|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.227|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.227
91547648|NCT03978871|182976227|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.272|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect for accuracy (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.272
91547649|NCT03978871|182976228|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.217|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.217
91765687|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.249|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|95.0|0.038|0.461|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours|||0.461|0.038|
91765688|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.238|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|0.047|0.429|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours|||0.429|0.047|
91765689|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315|STANDARD_ERROR_OF_MEAN|0.0995|||TWO_SIDED|95.0|0.114|0.516|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours|||0.516|0.114|
91547650|NCT03978871|182976228|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.458|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.458
91765690|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1111|||TWO_SIDED|95.0|0.143|0.591|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours|||0.591|0.143|
91765691|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|0.151|0.571|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours|||0.571|0.151|
91765692|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1168|||TWO_SIDED|95.0|0.131|0.602|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour|||0.602|0.131|
91765693|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.424|STANDARD_ERROR_OF_MEAN|0.1336|||TWO_SIDED|95.0|0.155|0.694|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours|||0.694|0.155|
91765694|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_ERROR_OF_MEAN|0.1174|||TWO_SIDED|95.0|0.319|0.793|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours|||0.793|0.319|
91765695|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.593|STANDARD_ERROR_OF_MEAN|0.1297||||95.0|0.331|0.854|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours|||0.854|0.331|
91765696|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.559|STANDARD_ERROR_OF_MEAN|0.1177|||TWO_SIDED|95.0|0.322|0.797|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours|||0.797|0.322|
91765697|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.522|STANDARD_ERROR_OF_MEAN|0.1076||||95.0|0.304|0.739|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours|||0.739|0.304|
91765698|NCT00857857|183420247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.514|STANDARD_ERROR_OF_MEAN|0.1017||||95.0|0.308|0.719|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours|||0.719|0.308|
91765699|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.1038||||95.0|0.086|0.503|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7|||0.503|0.086|
91765700|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.0884|||TWO_SIDED|95.0|0.007|0.363|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13|||0.363|0.007|
91765701|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.144|STANDARD_ERROR_OF_MEAN|0.1026|||TWO_SIDED|95.0|-0.062|0.351|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14|||0.351|-0.062|
91765702|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.0979|||TWO_SIDED|95.0|0.133|0.527|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7|||0.527|0.133|
91765703|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081|STANDARD_ERROR_OF_MEAN|0.0856|||TWO_SIDED|95.0|-0.092|0.253|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13|||0.253|-0.092|
91765704|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.076|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14|||0.327|-0.076|
91765705|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.297|STANDARD_ERROR_OF_MEAN|0.0976|||TWO_SIDED|95.0|0.1|0.493|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7|||0.493|0.100|
91765706|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.083|0.429|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13|||0.429|0.083|
91765707|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.462|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.262|0.662|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14|||0.662|0.262|
91765708|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.323|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.125|0.52|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7|||0.520|0.125|
91765709|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|0.057|0.402|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13|||0.402|0.057|
91765710|NCT00857857|183420249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.172|0.572|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14|||0.572|0.172|
91765711|NCT00857857|183420259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|95.0|-1.3|0.66|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||0.66|-1.30|
91765712|NCT00857857|183420259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-0.73|1.28|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||1.28|-0.73|
91765713|NCT00857857|183420259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.36|2.19|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.19|0.36|
91765714|NCT00857857|183420259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|0.469|||TWO_SIDED|95.0|0.84|2.75|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.75|0.84|
91547651|NCT03978871|182976228|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.037|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.037
91547652|NCT03978871|182976228|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.107|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.107
91547653|NCT03978871|182976228|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.369|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation cognitive avoidance subscale post psycho-educational lesson. This is a test of between-subjects test.||||0.369
91547654|NCT03978871|182976229|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative immerse \> neutral immerse) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.265||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -1.12||||||0.265
91547655|NCT03978871|182976230|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative \> neutral) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.96||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = -0.53||||||0.96
91547656|NCT03978871|182976231|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.76||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -.3047||||||0.76
91547657|NCT03978871|182976232|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.048||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.998, p = .048||||||.048
91547658|NCT03978871|182976233|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.833|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.833
91547659|NCT03978871|182976234|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.321|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) across self-reported affect on the SET task. This is a test of between-subjects effect.||||0.321
91547660|NCT03978871|182976235|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.002|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) for fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.002
91547661|NCT03978871|182976235|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.005|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons included as a covariate.||||0.005
91547662|NCT03978871|182976236|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.033|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||.033
91547663|NCT03978871|182976237|SUPERIORITY|Threshold for statistical significance was p = 0.05||||||0.403|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.403
91547664|NCT03978871|182976237|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.19|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.190
91547665|NCT03978871|182976238|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.784||||||degrees of freedom = 1.|ANOVA|||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.784
91547666|NCT03978871|182976238|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.586|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.586
91547667|NCT03978871|182976239|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.916|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.916
91547668|NCT03978871|182976239|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.343|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.343
91547669|NCT03978871|182976240|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.048
91547670|NCT03978871|182976240|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.153|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lesson was included as a covariate.||||0.153
91547671|NCT03978871|182976241|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.566|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.566
91547672|NCT03978871|182976241|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.048
91547673|NCT03978871|182976241|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.266|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.266
91547674|NCT03978871|182976241|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.402|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.402
91547675|NCT03978871|182976242|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.363|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
91547676|NCT03978871|182976242|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.363|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
91547677|NCT03978871|182976242|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.583|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.583
91547678|NCT03978871|182976242|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.379|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.379
91547679|NCT03978871|182976242|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.246|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.246
91547680|NCT03978871|182976243|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative reframe \> negative immerse) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were then averaged to produce a single value each.A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control)||||||0.455||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = .75||||||0.455
91547681|NCT03978871|182976244|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative \> neutral) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were subsequently averaged to produce a single value per person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.43||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(145) = 0.80||||||0.43
91547682|NCT03978871|182976245|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Timeseries were averaged to produce a single value representing each ROI's mean activity. Values for each ROI were then averaged to produce a single value per person representing mean network activity. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.29||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = -1.057||||||0.29
91547683|NCT03978871|182976246|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.88||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = 0.148||||||0.88
91547684|NCT03978871|182976247|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.11||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.631||||||.11
91547685|NCT03978871|182976248|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Pearson correlations were calculated between each mean BOLD signal in the CON and each amygdala ROI to produce 24 connectivity values. These were averaged to produce a single value representing the strength of coupling of the CON network to the amygdala for each participant. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.92||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = 0.101||A two-sample t-test was conducted to compare average connectivity (between the amygdala and the CON network) during resting state between the mindset and control groups.||||0.92
91547686|NCT03978871|182976249|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||2.22e-05||||||Reported result for cluster localized in the Superior/Middle Temporal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000222
91547687|NCT03978871|182976249|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.17e-05||||||Reported result for cluster localized in the Middle Temporal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000117
91547688|NCT03978871|182976249|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||"Reported result for cluster localized in the Anterior Cingulate/Medial Frontal Gyrus.~FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels."|t-test, 2 sided|||||||.000000000
91547689|NCT03978871|182976249|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.86e-05||||||Reported result for cluster localized in the Middle Frontal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000186
91547690|NCT03978871|182976249|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||Reported result for cluster localized in the Middle Frontal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.000000000
91547691|NCT03978871|182976249|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.61e-05||||||Reported result for cluster localized in the Posterior Cingulate/Cingulate. FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000161
91547692|NCT03978871|182976249|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative reframe \> negative immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005.|||||>|0.001||||||pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 298 voxels.|t-test, 2 sided|||||||>.001
91547693|NCT03978871|182976250|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.56|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.560
91547694|NCT03978871|182976251|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.327|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.327
91547695|NCT03978871|182976252|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.439|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.439
91547696|NCT03978871|182976252|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.545|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.545
91547697|NCT03978871|182976253|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.74|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.740
91547698|NCT04166773|182976261|SUPERIORITY||Odds Ratio (OR)|7.45|||<|0.001|TWO_SIDED|95.0|2.27|24.44|||Regression, Logistic||Odds ratio, Confidence Interval (CI), and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||24.44|2.27|<0.001
91547699|NCT04166773|182976261|SUPERIORITY||Odds Ratio (OR)|11.86|||<|0.001|TWO_SIDED|95.0|3.59|39.11|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||39.11|3.59|<0.001
91547700|NCT04166773|182976261|SUPERIORITY||Odds Ratio (OR)|19.63|||<|0.001|TWO_SIDED|95.0|5.73|67.25|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||67.25|5.73|<0.001
91547701|NCT04166773|182976262|SUPERIORITY||Odds Ratio (OR)|3.01||||0.025|TWO_SIDED|95.0|1.15|7.9|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||7.90|1.15|0.025
91547702|NCT04166773|182976262|SUPERIORITY||Odds Ratio (OR)|2.37||||0.074|TWO_SIDED|95.0|0.92|6.13|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors|||6.13|0.92|0.074
91547703|NCT04166773|182976262|SUPERIORITY||Odds Ratio (OR)|2.47||||0.063|TWO_SIDED|95.0|0.95|6.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||6.40|0.95|0.063
91547704|NCT04166773|182976263|SUPERIORITY||Odds Ratio (OR)|0.91||||0.893|TWO_SIDED|95.0|0.25|3.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||3.40|0.25|0.893
91547705|NCT04166773|182976263|SUPERIORITY||Odds Ratio (OR)|0.73||||0.647|TWO_SIDED|95.0|0.18|2.87|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||2.87|0.18|0.647
91547706|NCT04166773|182976263|SUPERIORITY||Odds Ratio (OR)|0.39||||0.246|TWO_SIDED|95.0|0.08|1.91|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||1.91|0.08|0.246
91547707|NCT04166773|182976264|SUPERIORITY||Odds Ratio (OR)|6.94|||<|0.001|TWO_SIDED|95.0|2.41|20.0|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||20.00|2.41|<0.001
91547708|NCT04166773|182976264|SUPERIORITY||Odds Ratio (OR)|10.46|||<|0.001|TWO_SIDED|95.0|3.36|32.61|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||32.61|3.36|<0.001
91547709|NCT04166773|182976264|SUPERIORITY||Odds Ratio (OR)|12.85|||<|0.001|TWO_SIDED|95.0|3.87|42.65|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||42.65|3.87|<0.001
91547710|NCT04166773|182976265|SUPERIORITY||LS Mean difference (Final Values)|-8.81|STANDARD_ERROR_OF_MEAN|1.632|<|0.001|TWO_SIDED|95.0|-12.04|-5.58|||Mixed Models Analysis|||||-5.58|-12.04|<0.001
91547711|NCT04166773|182976265|SUPERIORITY||LS Mean difference (Final Values)|-8.83|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|-11.93|-5.73|||Mixed Models Analysis|||||-5.73|-11.93|<0.001
91547712|NCT04166773|182976265|SUPERIORITY||LS Mean difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-13.17|-6.87|||Mixed Models Analysis|||||-6.87|-13.17|<0.001
91547713|NCT04166773|182976266|SUPERIORITY||LS Mean difference (Final Values)|-10.42|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-14.32|-6.52|||Mixed Models Analysis|||||-6.52|-14.32|<0.001
91547714|NCT04166773|182976266|SUPERIORITY||LS Mean difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-17.05|-9.32|||Mixed Models Analysis|||||-9.32|-17.05|<0.001
91547715|NCT04166773|182976266|SUPERIORITY||LS Mean difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|1.957|<|0.001|TWO_SIDED|95.0|-20.71|-12.98|||Mixed Models Analysis|||||-12.98|-20.71|<0.001
91547716|NCT03033576|182976317|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.04|TWO_SIDED|90.0|0.41|0.97||Pre-specified one-sided alpha=0.1|Log Rank|||The statistical design assumed exponential PFS with a median of 3.0 months on the ipilimumab group (null hypothesis). The study was powered to detect a change in median PFS to 6.0 months in the combination therapy group (corresponding to an HR of 0.50). A total of 84 participants (63 randomized to combination group and 21 to ipilimumab group) with 78 events (across both groups) would provide 89% power for a one-sided alpha of 10% using a log-rank test.||0.97|0.41|0.04
91547717|NCT03033576|182976320|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.28|TWO_SIDED|90.0|0.5|1.39|||Log Rank|||||1.39|0.50|0.28
91547718|NCT03526874|182976322|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
91547719|NCT03526874|182976323|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|||||||0.031
91547720|NCT03526874|182976324|SUPERIORITY|||||||0.0162|||||||ANOVA|Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0162
91547721|NCT03526874|182976325|SUPERIORITY|||||||0.04||||||Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.|ANOVA|||||||0.04
91547722|NCT03526874|182976326|SUPERIORITY|||||||0.0098|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0098
91547723|NCT03526874|182976327|SUPERIORITY|||||||0.02|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.02
91547724|NCT03526874|182976328|SUPERIORITY|||||||0.01|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.01
91547725|NCT03526874|182976329|SUPERIORITY|||||||0.0329|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0329
91547726|NCT03526874|182976330|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||||||0.294
91547727|NCT03526874|182976331|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
91547728|NCT03526874|182976332|SUPERIORITY|||||||0.182|||||||t-test, 2 sided|||||||0.182
91547729|NCT03526874|182976333|SUPERIORITY|||||||0.423|||||||Fisher Exact|||||||0.423
91547730|NCT03526874|182976334|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
91547731|NCT03526874|182976335|SUPERIORITY|||||||0.112|||||||Fisher Exact|||||||0.112
91547732|NCT03526874|182976336|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
91547733|NCT03526874|182976337|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
91547734|NCT02596126|182976435|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI). If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.76|||<|0.025|TWO_SIDED|95.0|0.6|0.96|||Regression, Cox|||||0.96|0.6|< 0.025
91547735|NCT02596126|182976435|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
91547736|NCT02596126|182976436|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Risk Ratio (RR)|1.13|||<|0.005|TWO_SIDED|95.0|1.06|1.2|||Chi-squared|||Statistical analysis title - Treatment adherence at 6 months||1.2|1.06|< 0.005
91547737|NCT02596126|182976437|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|0.97|||<|0.05|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||Statistical analysis title - All-cause death||1.25|0.75|< 0.05
91547738|NCT02596126|182976438|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky- Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high(8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Hazard Ratio (HR)|1.17|||<|0.005|TWO_SIDED|95.0|1.1|1.25|||Chi-squared|||Statistical analysis title - Treatment adherence at 24 months||1.25|1.1|< 0.005
91547739|NCT02596126|182976439|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-1.8|1.2||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 6 months||1.2|-1.8|< 0.05
91547740|NCT02596126|182976440|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.1|3.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 12 months||3|-0.1|< 0.05
91547741|NCT02596126|182976441|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-1.7|1.4||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 24 months||1.4|-1.7|< 0.05
91547742|NCT02596126|182976442|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.7|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 6 months||1|-0.7|< 0.05
91547743|NCT02596126|182976443|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|-0.1|1.6||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 12 months||1.6|-0.1|< 0.05
91547744|NCT02596126|182976444|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.9|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 24 months||1|-0.9|< 0.05
91547745|NCT02596126|182976445|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|2.1|||<|0.05|TWO_SIDED|95.0|-0.2|4.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 12 months||4.4|-0.2|< 0.05
91547746|NCT02596126|182976446|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-2.5|2.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 24 months||2.4|-2.5|< 0.05
91547747|NCT02596126|182976447|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.54|0.9|||Regression, Cox|||||0.90|0.54|< 0.025
91547748|NCT02596126|182976447|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
91547749|NCT02596126|182976448|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.67|||<|0.025|TWO_SIDED|95.0|0.47|0.97|||Regression, Cox|||||0.97|0.47|< 0.025
91547750|NCT02596126|182976448|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
91547751|NCT02596126|182976449|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.71|||<|0.025|TWO_SIDED|95.0|0.48|1.05|||Regression, Cox|||||1.05|0.48|< 0.025
91547752|NCT02596126|182976449|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
91547753|NCT02596126|182976450|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.39|1.26|||Regression, Cox|||||1.26|0.39|< 0.025
91547754|NCT02596126|182976450|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
91547755|NCT02596126|182976451|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.96|||<|0.025|TWO_SIDED|95.0|0.57|1.63|||Regression, Cox|||||1.63|0.57|< 0.025
91547756|NCT02596126|182976451|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
91547757|NCT02596126|182976452|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.09|||<|0.05|TWO_SIDED|95.0|1.38|4.79|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||4.79|1.38|< 0.05
91547758|NCT02596126|182976453|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|-5.19|||<|0.05|TWO_SIDED|95.0|-12.73|2.35|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||2.35|-12.73|< 0.05
91547759|NCT02596126|182976454|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.09|||<|0.05|TWO_SIDED|95.0|5.57|8.62|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.62|5.57|< 0.05
91547760|NCT02596126|182976455|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.79|||<|0.05|TWO_SIDED|95.0|2.04|5.55|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||5.55|2.04|< 0.05
91547761|NCT02596126|182976456|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|5.26|||<|0.05|TWO_SIDED|95.0|3.59|6.94|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||6.94|3.59|< 0.05
91547762|NCT02596126|182976457|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|4.55|||<|0.05|TWO_SIDED|95.0|-4.35|13.46|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||13.46|-4.35|< 0.05
91547763|NCT02596126|182976458|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.11|||<|0.05|TWO_SIDED|95.0|5.55|8.67|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.67|5.55|< 0.05
91547764|NCT02596126|182976459|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|6.6|||<|0.05|TWO_SIDED|95.0|4.93|8.27|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.27|4.93|< 0.05
91547765|NCT02596126|182976460|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|1.42|||<|0.05|TWO_SIDED|95.0|0.97|2.07|||Log Rank|||Statistical analysis title - Non-cardiovascular death||2.07|0.97|< 0.05
91547766|NCT05529966|182976466|OTHER|||||||0.45490734||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.45490734
91547767|NCT05529966|182976467|OTHER|||||||0.9237611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.92376110
91547768|NCT05529966|182976468|OTHER|||||||0.94342221||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.94342221
91547769|NCT05529966|182976469|OTHER|||||||0.38902793||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.38902793
91547770|NCT05529966|182976470|OTHER|||||||0.0042494||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of comfort score||||0.00424940
91547771|NCT05529966|182976470|OTHER|||||||0.00223547||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.00223547
91547772|NCT05529966|182976470|OTHER|||||||1.858e-05||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.00001858
91547773|NCT05529966|182976470|OTHER|||||||0.03003194||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.03003194
91547774|NCT05529966|182976470|OTHER|||||||2.8e-07||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.00000028
91547775|NCT05529966|182976470|OTHER|||||||0.00112148||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.00112148
91547776|NCT05529966|182976470|OTHER|||||||951||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||00000951
91547777|NCT05529966|182976470|OTHER|||||||0.03493564||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.03493564
91547778|NCT05529966|182976470|OTHER|||||||0.12895248||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.12895248
91547779|NCT05529966|182976470|OTHER|||||||0.00279611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.00279611
91547780|NCT05529966|182976471|OTHER|||||||0.959638658||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Comfort score||||.959638658
91547781|NCT05529966|182976471|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.213464715
91547782|NCT05529966|182976471|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.213464715
91547783|NCT05529966|182976471|OTHER|||||||0.155899777||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.155899777
91547784|NCT05529966|182976471|OTHER|||||||0.055960023||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.055960023
91547785|NCT05529966|182976471|OTHER|||||||0.000685499||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.000685499
91547786|NCT05529966|182976471|OTHER|||||||0.004526118||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||.004526118
91547787|NCT05529966|182976471|OTHER|||||||0.299921137||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.299921137
91547788|NCT05529966|182976471|OTHER|||||||0.368082084||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.368082084
91547789|NCT05529966|182976471|OTHER|||||||0.015036417||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.015036417
91547790|NCT03648840|182976478|OTHER||||||<|0.2|||||||t-test, 2 sided|||2-tailed, unpaired T-test||||<0.2
91547791|NCT02995434|182976489|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model.|Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.86|-0.3|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|Null hypothesis: There is no difference between the reported daily pain experiences of participants during, or after exposure to VR immersive environments, overall and within four different VR immersive environments, compared to the equivalent applications experienced on a 2D computer screen.||-0.30|-3.86|
91547792|NCT02995434|182976489|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model|Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-1.24|2.37|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.37|-1.24|
91547793|NCT02995434|182976490|EQUIVALENCE|See section for primary outcome.|Mean Difference (Net)|1.08|||||TWO_SIDED|95.0|-1.59|3.95|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.95|-1.59|
91547794|NCT02995434|182976490|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.16|||||TWO_SIDED|95.0|-0.55|5.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.08|-0.55|
91547795|NCT02995434|182976490|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-2.64|3.42|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.42|-2.64|
91547796|NCT02995434|182976490|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.56|||||TWO_SIDED|95.0|-0.08|5.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.48|-0.08|
91547797|NCT02995434|182976491|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.37|||||TWO_SIDED|95.0|-0.71|1.5|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.5|-0.71|
91547798|NCT02995434|182976491|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.62|||||TWO_SIDED|95.0|-0.49|1.89|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.89|-0.49|
91547799|NCT02995434|182976491|EQUIVALENCE|See comments in primary outcome|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-1.19|1.09|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.09|-1.19|
91547800|NCT02995434|182976491|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.33|||||TWO_SIDED|95.0|-0.88|1.57|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.57|-0.88|
91547801|NCT02995434|182976492|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.48|||||TWO_SIDED|95.0|0.02|4.7|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.70|0.02|
91547802|NCT02995434|182976492|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.04|||||TWO_SIDED|95.0|-0.42|4.39|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.39|-0.42|
91547803|NCT02995434|182976492|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.79|||||TWO_SIDED|95.0|1.02|6.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||6.08|1.02|
91547804|NCT02995434|182976492|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.18|||||TWO_SIDED|95.0|0.68|5.69|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.69|0.68|
91547805|NCT02995434|182976493|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-2.31|||||TWO_SIDED|95.0|-5.63|0.98|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||0.98|-5.63|
91547806|NCT02995434|182976493|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-7.35|-0.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||-0.48|-7.35|
91547807|NCT02995434|182976493|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-0.87|||||TWO_SIDED|95.0|-4.11|2.62|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.62|-4.11|
91547808|NCT02995434|182976493|EQUIVALENCE|See comments in primary outcome|Median Difference (Net)|-2.95|||||TWO_SIDED|95.0|-6.1|0.41|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method.|||0.41|-6.10|
91547809|NCT03400059|182976494|SUPERIORITY||Mean Difference (Final Values)|-2.23||||0.0132|TWO_SIDED|95.0|-4.11|-0.49||"analysis of covariance (ANCOVA) model containing terms for treatment, baseline value and medication overuse.~Group-sequential analysis using updated boundaries from interim analysis"|ANCOVA|||||-0.49|-4.11|0.0132
91547810|NCT03400059|182976495|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0014|TWO_SIDED|95.0|-4.32|-1.04|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-1.04|-4.32|0.0014
91547811|NCT03400059|182976496|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.0048|TWO_SIDED|95.0|-4.06|-0.73|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-0.73|-4.06|0.0048
91547812|NCT03400059|182976497|SUPERIORITY||Mean Difference (Final Values)|-2.87||||0.0008|TWO_SIDED|95.0|-4.54|-1.2|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-1.20|-4.54|0.0008
91547813|NCT03400059|182976498|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.0598|TWO_SIDED|95.0|-3.12|0.06|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||0.06|-3.12|0.0598
91547814|NCT03400059|182976499|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.031|TWO_SIDED|95.0|-3.63|-0.17|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-0.17|-3.63|0.0310
91547815|NCT03400059|182976500|SUPERIORITY|||||||0.0102|||||||Chi-squared|||||||0.0102
91547816|NCT03400059|182976501|SUPERIORITY|||||||0.1615|||||||Chi-squared|||||||0.1615
91547817|NCT03400059|182976502|SUPERIORITY|||||||0.0798|||||||Chi-squared|||||||0.0798
91547818|NCT03400059|182976503|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.1300
91547819|NCT03400059|182976504|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.066|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0660
91547820|NCT03400059|182976505|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.0152|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0152
91547821|NCT04150718|182976512|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at \<0.05|ANOVA|Repeated measures ANOVA, main effect of time, F(1,35) =4.73||||||<0.05
91547822|NCT04150718|182976513|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at p\<0.05.|ANOVA|Repeated Measures ANOVA, main effect of time, F(1,39) = 4.20||||||<0.05
91547823|NCT04150718|182976514|OTHER||||||<|0.001||||||a priori threshold for statistical significance set at p \<0.05|ANOVA|Repeated measures ANOVA interaction, F(1,48) = 61.849||||||<0.001
91547824|NCT05493423|182976531|NON_INFERIORITY|The null hypothesis is that the difference between the rates of completed hemodialysis sessions for the test and control groups is less than or equal to the non-inferiority margin (indicating inferior success rate). Rejection of the null hypothesis indicates the data supports the alternative hypothesis that the difference between the rates of successfully completed HD sessions for the test and control groups is at least the non-inferiority margin (indicating non-inferior success rate).||||||0.008|||||||Farrington-Manning|non-inferiority margin = 0.08||||||.008
91547825|NCT05493423|182976531|EQUIVALENCE|non-inferiority margin = 0.08||||||0.002|||||||Equivalence Test with paired data|||||||.002
91547826|NCT05493423|182976532|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
91547827|NCT05493423|182976533|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
91547828|NCT05493423|182976534|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||||||0.132
91547829|NCT05493423|182976535|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
91547830|NCT05493423|182976536|SUPERIORITY|||||||0.197||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.197
91547831|NCT05493423|182976537|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
91547832|NCT05493423|182976538|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
91547833|NCT05493423|182976539|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to as 0 by the statistical software.|t-test, 2 sided|||||||0
91547834|NCT05493423|182976540|SUPERIORITY|||||||0.57||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.57
91547835|NCT05493423|182976541|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
91547836|NCT05493423|182976542|SUPERIORITY|||||||0.211|||||||t-test, 2 sided|||||||0.211
91547837|NCT05493423|182976543|SUPERIORITY|||||||0.804||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.804
91547838|NCT05493423|182976544|SUPERIORITY|||||||0.307||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.307
91547839|NCT05493423|182976545|SUPERIORITY|||||||0.315||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.315
91547840|NCT01426425|182976559|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.926|||<|0.0001|TWO_SIDED|95.0|0.895|0.948|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.83~Ha: PE \> 0.83~Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal."||0.948|0.895|<0.0001
91547841|NCT01426425|182976560|SUPERIORITY_OR_OTHER_LEGACY||Safety failure probability at 6 months|0.01|||<|0.0001|TWO_SIDED|95.0|0.004|0.027|||Kaplan-Meier log-log 95% CI||The chronic safety failure probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: Ps ≥ 0.07~Ha: Ps \< 0.07~Where Ps is the probability of a subject experiencing at least one safety event through 6 months with a 0.07 pre-specified performance goal."||0.027|0.004|<0.0001
91547842|NCT01426425|182976561|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.973|||<|0.0001|TWO_SIDED|95.0|0.95|0.985|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.80~Ha: PE \> 0.80~Where PE is the probability of a subject achieving chronic effectiveness success at 6-month follow-up, and 0.80 is the pre-specified performance goal. As pre-defined in the study protocol, this hypothesis is tested if the primary effectiveness objective null hypothesis (Ho) is rejected."||0.985|0.950|<0.0001
91547843|NCT03281291|182976568|OTHER||Vaccine Efficacy|29.7|||||TWO_SIDED|95.0|14.7|42.1|||Regression, Cox||VE = 1 minus the Hazard Ratio (HR). HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy (VE) in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||42.1|14.7|
91547844|NCT03281291|182976568|OTHER||Vaccine Efficacy|31.2|||||TWO_SIDED|95.0|16.4|43.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||43.3|16.4|
91547845|NCT03281291|182976568|OTHER||Vaccine Efficacy|24.6|||||TWO_SIDED|95.0|9.0|37.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||37.6|9.0|
91547846|NCT03281291|182976568|OTHER||Vaccine Efficacy|28.8|||||TWO_SIDED|95.0|13.9|41.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||41.1|13.9|
91547847|NCT03281291|182976569|OTHER||Vaccine Efficacy|42.8|||||TWO_SIDED|95.0|30.7|52.8|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||52.8|30.7|
91547848|NCT03281291|182976569|OTHER||Vaccine Efficacy|36.7|||||TWO_SIDED|95.0|21.2|49.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for Fx012-14-mFxD Group vs Control Group.||49.2|21.2|
91547849|NCT03281291|182976569|OTHER||Vaccine Efficacy|41.4|||||TWO_SIDED|95.0|26.7|53.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 19, for Fx017-mFxD Group vs Control Group.||53.1|26.7|
91547850|NCT03281291|182976570|OTHER||Vaccine Efficacy|29.6|||||TWO_SIDED|95.0|15.4|41.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||41.5|15.4|
91547851|NCT03281291|182976570|OTHER||Vaccine Efficacy|30.6|||||TWO_SIDED|95.0|16.6|42.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||42.2|16.6|
91547852|NCT03281291|182976570|OTHER||Vaccine Efficacy|27.4|||||TWO_SIDED|95.0|13.1|39.4|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||39.4|13.1|
91547853|NCT03281291|182976570|OTHER||Vaccine Efficacy|26.3|||||TWO_SIDED|95.0|11.9|38.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||38.3|11.9|
91547854|NCT03281291|182976571|OTHER||Vaccine Efficacy|41.8|||||TWO_SIDED|95.0|28.6|52.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-20 Group vs Control Group.||52.5|28.6|
91547855|NCT03281291|182976571|OTHER||Vaccine Efficacy|39.9|||||TWO_SIDED|95.0|26.8|50.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-14-mD Group vs Control Group.||50.6|26.8|
91547856|NCT03281291|182976571|OTHER||Vaccine Efficacy|33.6|||||TWO_SIDED|95.0|19.3|45.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for Fx012-14-mFxD Group vs Control Group.||45.3|19.3|
91547857|NCT03281291|182976571|OTHER||Vaccine Efficacy|40.6|||||TWO_SIDED|95.0|27.2|51.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 31, for Fx017-mFxD Group vs Control Group.||51.5|27.2|
91547858|NCT03281291|182976572|OTHER||Additive difference|-1.5|||||TWO_SIDED|95.0|-1.979|-1.022|||Wald Test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||-1.022|-1.979|
91547859|NCT03281291|182976572|OTHER||Additive difference|-1.544|||||TWO_SIDED|95.0|-2.027|-1.061|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||-1.061|-2.027|
91547860|NCT03281291|182976572|OTHER||Additive difference|-1.575|||||TWO_SIDED|95.0|-2.065|-1.085|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||-1.085|-2.065|
91547861|NCT03281291|182976572|OTHER||Additive difference|-1.11|||||TWO_SIDED|95.0|-1.635|-0.586|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||-0.586|-1.635|
91547862|NCT03281291|182976573|OTHER||Additive difference|-0.769|||||TWO_SIDED|95.0|-1.068|-0.469|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||-0.469|-1.068|
91547863|NCT03281291|182976573|OTHER||Additive difference|-0.786|||||TWO_SIDED|95.0|-1.133|-0.439|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for Fx012-14-mFxD groups vs Control Group.||-0.439|-1.133|
91547864|NCT03281291|182976573|OTHER||Additive difference|-1.275|||||TWO_SIDED|95.0|-1.592|-0.959|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 19, for Fx017-mFxD groups vs Control Group.||-0.959|-1.592|
91547865|NCT03281291|182976574|OTHER||Additive difference|-2.686|||||TWO_SIDED|95.0|-3.448|-1.924|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||-1.924|-3.448|
91547866|NCT03281291|182976574|OTHER||Additive difference|-2.452|||||TWO_SIDED|95.0|-3.217|-1.686|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||-1.686|-3.217|
91547867|NCT03281291|182976574|OTHER||Additive difference|-2.585|||||TWO_SIDED|95.0|-3.345|-1.824|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||-1.824|-3.345|
91547868|NCT03281291|182976574|OTHER||Additive difference|-1.897|||||TWO_SIDED|95.0|-2.726|-1.067|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||-1.067|-2.726|
91547869|NCT03281291|182976575|OTHER||Additive difference|-1.633|||||TWO_SIDED|95.0|-2.252|-1.015|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-20 group vs Control Group.||-1.015|-2.252|
91547870|NCT03281291|182976575|OTHER||Additive difference|-1.997|||||TWO_SIDED|95.0|-2.601|-1.393|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-14 group vs Control Group.||-1.393|-2.601|
91547871|NCT03281291|182976575|OTHER||Additive difference|-1.776|||||TWO_SIDED|95.0|-2.399|-1.153|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for Fx012-14-mFxD group vs Control Group.||-1.153|-2.399|
91547872|NCT03281291|182976575|OTHER||Additive difference|-1.843|||||TWO_SIDED|95.0|-2.527|-1.158|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 31, for Fx017-mFxD group vs Control Group.||-1.158|-2.527|
91547873|NCT05862870|182976604|OTHER|Frequency count|exact count|20.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|0.0|20.0|20.0|||count|||Frequency count of patients retained in treatment.|Threshold for frequency count|20|20|.05
91547874|NCT03143153|182976611|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|98.6|0.46|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model.|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.90|0.46|0.0010
91547875|NCT03143153|182976611|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|95.0|0.49|0.84||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.84|0.49|0.0010
91547876|NCT03143153|182976611|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|99.5|0.37|0.8||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.80|0.37|<0.0001
91547877|NCT03143153|182976611|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.71|0.41|<0.0001
91547878|NCT03143153|182976612|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|98.5|0.73|1.43||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.43|0.73|0.8958
91547879|NCT03143153|182976612|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|95.0|0.78|1.34||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.34|0.78|0.8958
91547880|NCT03143153|182976612|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|98.5|0.46|0.92||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.92|0.46|0.0023
91547881|NCT03143153|182976612|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|95.0|0.49|0.86||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.86|0.49|0.0023
91547882|NCT03143153|182976613|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||95.0|0.65|0.95||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.95|0.65|0.0110
91547883|NCT03143153|182976613|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||98.2|0.62|0.98||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.98|0.62|0.0110
91547884|NCT03143153|182976613|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021||99.1|0.58|0.96||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.96|0.58|0.0021
91547885|NCT03143153|182976613|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021|TWO_SIDED|95.0|0.61|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.90|0.61|0.0021
91547886|NCT03143153|182976614|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|1.04|1.52|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.52|1.04|
91547887|NCT03143153|182976614|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|95.0|0.67|0.99||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.99|0.67|0.0355
91547888|NCT03143153|182976614|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|98.5|0.64|1.04||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||1.04|0.64|0.0355
91765715|NCT03057496|183420377|SUPERIORITY||Rate ratio|0.627|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.536|0.734||Since the outcome (contacts) represented over-dispersed count data and there were repeated measurements per subject, a generalized mixed effects model with a negative binomial family was used with each subject treated as a random intercept.|Mixed Models Analysis|Fixed factors were included in the model to account for factors other than device operating mode that might affect collision rates.|Silent mode is the denominator for the rate ratio.|A within-subject comparison was performed. Each subject included in the analysis used the device in both the active and the silent mode. Comparison was between the two device operating modes. The null hypothesis was that there was no difference in the rate of contacts between active and silent modes.||0.734|0.536|< 0.001
91765716|NCT00997035|183420415|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.29|TWO_SIDED|95.0|0.57|1.18|||Regression, Cox|Cox proportional hazards regression to estimate the hazard of perforation or need for TPK.||The sample size was determined based on the primary end point: perforation or the need for TPK within 3 months. Simulation-based analyses estimated that a sample sizeof 240 study participants (120 per arm) would provide 80% power to detect a 15% difference in the 3-month perforation or need for TPK rate between topical antifungal plus oral voriconazole vs topical antifungal alone,with a 2-tailed α value of .05 and approximately 15%loss to follow-up.||1.18|0.57|0.29
91765717|NCT00997035|183420420|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.65|TWO_SIDED|95.0|0.49|1.57|||Regression, Cox|||||1.57|.49|0.65
91547889|NCT02736409|182976621|SUPERIORITY||Difference in Proportion|-0.19||||0.131|TWO_SIDED|95.0|-0.452|0.082|||Fisher Exact|||||0.082|-0.452|0.131
91547890|NCT03498651|182976692|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|1.04|1.16|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||1.16|1.04|
91547891|NCT03498651|182976692|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.43|0.2|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.20|-0.43|
91547892|NCT03498651|182976693|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.69|-0.57|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.57|-0.69|
91547893|NCT03498651|182976693|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.26|
91547894|NCT03498651|182976694|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|0.42|0.54|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.||"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|0.54|0.42|
91547895|NCT03498651|182976694|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.23|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.23|
91547896|NCT03498651|182976695|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_DEVIATION|0.02|||TWO_SIDED|95.0|-0.6|-0.51|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.51|-0.60|
91765718|NCT00997035|183420422|SUPERIORITY||||||<|0.001||||||Statistically significant after Holms-Šidák correction for multiple comparisons.|Fisher Exact|||||||<0.001
91765719|NCT03456076|183420440|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.45|||Log Rank|||||0.45|0.13|.0001
91765720|NCT03456076|183420440|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.43|||Log Rank|||||0.43|0.13|.0001
91765721|NCT00466440|183420446|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||1|TWO_SIDED|90.0|-12.52|12.95|||Chi-squared||The objective response rates and the 90% confidence intervals were estimated for the qualified participants using unadjusted normal approximation for binomial proportions (z approximation).|||12.95|-12.52|1.0000
91765722|NCT00466440|183420447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6||||0.3606|TWO_SIDED|90.0|-28.21|4.95|||Chi-squared|||||4.95|-28.21|0.3606
91547897|NCT03498651|182976695|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13|||TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.27|-0.23|
91547898|NCT03498651|182976696|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.46|-0.37|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.37|-0.46|
91547899|NCT03498651|182976696|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.14|||TWO_SIDED|95.0|-0.23|0.32|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.32|-0.23|
91547900|NCT03498651|182976697|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.39|-0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.27|-0.39|
91547901|NCT03498651|182976697|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.14|0.48|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.48|-0.14|
91547902|NCT02243709|182976745|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
91547903|NCT01748448|182976748|SUPERIORITY||Cox Proportional Hazard|1.27|||=|0.324|TWO_SIDED|95.0|0.79|2.03|||Fisher Exact|||||2.03|0.79|= 0.324
91547904|NCT03562377|182976754|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-11.3|3.1|||Mantel Haenszel|||||3.1|-11.3|
91547905|NCT03562377|182976755|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-9.2|12.8|||Mantel Haenszel|||||12.8|-9.2|
91547906|NCT03562377|182976756|SUPERIORITY||Risk Difference (RD)|11.4||||0.049|TWO_SIDED|95.0|0.2|22.6||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||22.6|0.2|0.049
91547907|NCT03562377|182976757|SUPERIORITY||Risk Difference (RD)|12.7||||0.057|TWO_SIDED|95.0|-0.2|25.7||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||25.7|-0.2|0.057
91547908|NCT03001414|182976760|SUPERIORITY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|16.69||0.42|TWO_SIDED|95.0|-20.08|47.48|||ANOVA|Global test of difference between the arms analyzed as absolute change from baseline.||Due to sample size restriction, the primary analysis plan was modified to analyze change from baseline to each time point using repeated measures of ANOVA.||47.48|-20.08|0.42
91765723|NCT00466440|183420448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.072|TWO_SIDED|90.0|-0.02|0.55|||t-test, 1 sided|||||0.55|-0.02|0.0720
91765724|NCT00466440|183420449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.1697|TWO_SIDED|90.0|-0.07|0.37|||t-test, 1 sided|||||0.37|-0.07|0.1697
91547909|NCT03001414|182976760|SUPERIORITY||Mean Difference (Final Values)|13.7||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Calculation of raw change from baseline in meters using non-parametric Wilcoxon test.||||0.57
91547910|NCT03001414|182976760|SUPERIORITY||Mean Difference (Final Values)|4.55||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Secondary analysis of primary outcome using non-parametric Wilcoxon test of percent change from baseline.||||||0.53
91547911|NCT03001414|182976761|SUPERIORITY|Change from baseline calculated in meters using non-parametric analysis.|Mean Difference (Final Values)|41.97||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of these arms is in accordance with the statistical analysis plan.||||0.10
91547912|NCT03001414|182976762|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The selected arm for this outcome measure is in accordance with the statistical analysis plan.||||0.50
91547913|NCT03001414|182976763|SUPERIORITY||Mean Difference (Final Values)|22.92||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Comparison of change from baseline in meters at 6 and 12 months.||Selection of the arm for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.88
91547914|NCT03001414|182976764|SUPERIORITY||Mean Difference (Final Values)|0.132||||0.81|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.81
91547915|NCT03001414|182976765|SUPERIORITY||Median Difference (Final Values)|2.06||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.63
91547916|NCT03001414|182976766|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
91547917|NCT03001414|182976767|SUPERIORITY||Mean Difference (Final Values)|5.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|This analysis represents the results for the Physical Component score of the questionnaire.||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||1.0
91547918|NCT03001414|182976767|SUPERIORITY||Median Difference (Final Values)|0.1||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the mental component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.64
91547919|NCT03001414|182976768|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the physical component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.40
91547920|NCT03001414|182976768|SUPERIORITY||Mean Difference (Final Values)|15.4||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||This analysis represents the change in score for the mental component of the questionnaire.|||0.23
91547921|NCT05177848|182976809|OTHER|||||||0.9793||||||"A linear mixed effects model tested the interaction between group and condition on the rate of substitution~Results:~Condition: X2(6) = 4.30, p = 0.64 Group: X2(1) 0.22, p = 0.64 Condition:Group: X2(6) = 1.15, p = 0.98"|Mixed Models Analysis|||||||0.9793
91547922|NCT05177848|182976810|OTHER|||||||0.29||||||"A linear mixed effects model tested the interaction between group and condition on Q0 (derived intensity).~Results:~Condition: X2(6) = 6.59, p = 0.36 Group: X2(1) = 0.07, p = 0.79 Condition:Group: X2(6) = 7.38, p = 0.29"|Mixed Models Analysis|||||||0.29
91547923|NCT05177848|182976810|OTHER|||||||0.46||||||"A linear mixed effects model tested the interaction between group and condition on Alpha (demand elasticity).~Results:~Condition: X2(6) = 0.0001, p = 1.00 Group: X2(1) = 0.00, p = 0.99 Condition:Group: X2(6) = 5.65, p = 0.46"|Mixed Models Analysis|||||||0.46
91547924|NCT05386758|182976820|OTHER||Gemetric Mean Ratio (GMR)|1.24|||||TWO_SIDED|90.0|0.94|1.64||||||||1.64|0.94|
91547925|NCT05386758|182976821|OTHER||Geometric Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.9|1.62||||||||1.62|0.90|
91547926|NCT01573442|182976826|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||||||0.4952
91547927|NCT01573442|182976827|SUPERIORITY|||||||0.2116|||||||Fisher Exact|||||||0.2116
91547928|NCT01573442|182976828|SUPERIORITY|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.6760
91547929|NCT01573442|182976829|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 1||||0.029
91765725|NCT00466440|183420450|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.524|TWO_SIDED|95.0|0.5|1.4|||Log Rank|||||1.4|0.5|0.5240
91547930|NCT01573442|182976829|SUPERIORITY|||||||0.8214|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 2||||0.8214
91547931|NCT01573442|182976829|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 3||||0.4952
91547932|NCT01573442|182976829|SUPERIORITY|||||||0.5232|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 4||||0.5232
91547933|NCT01573442|182976829|SUPERIORITY|||||||0.5522|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 5||||0.5522
91547934|NCT01573442|182976829|SUPERIORITY|||||||0.7005|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 6||||0.7005
91765726|NCT00466440|183420451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.4407|TWO_SIDED|95.0|0.3|1.6|||Log Rank|||||1.6|0.3|0.4407
91547935|NCT01573442|182976833|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
91547936|NCT01573442|182976834|SUPERIORITY|||||||0.8761|||||||Wilcoxon (Mann-Whitney)|||||||0.8761
91547937|NCT01573442|182976835|SUPERIORITY|||||||0.0176|||||||Wilcoxon (Mann-Whitney)|||||||0.0176
91547938|NCT01573442|182976836|SUPERIORITY|||||||0.7077|||||||Wilcoxon (Mann-Whitney)|||||||0.7077
91547939|NCT01573442|182976837|SUPERIORITY|||||||0.8748|||||||Wilcoxon (Mann-Whitney)|||||||0.8748
91547940|NCT01573442|182976838|SUPERIORITY|||||||0.4335|||||||Wilcoxon (Mann-Whitney)|||||||0.4335
91547941|NCT01573442|182976839|SUPERIORITY|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||||||0.286
91547942|NCT01573442|182976840|SUPERIORITY|||||||0.7694|||||||Wilcoxon (Mann-Whitney)|||||||0.7694
91547943|NCT01573442|182976841|SUPERIORITY|||||||0.9609|||||||Wilcoxon (Mann-Whitney)|||||||0.9609
91765727|NCT00466440|183420452|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.3449|TWO_SIDED|95.0|0.4|1.4|||Log Rank|||||1.4|0.4|0.3449
91765728|NCT03187132|183420462|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|1.17||0.111|TWO_SIDED|95.0|-4.15|0.43|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||.43|-4.15|.111
91547944|NCT03649659|182976842|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|99.9|2.54|6.48|||Regression, Logistic|Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.||||6.48|2.54|<0.0001
91547945|NCT03649659|182976843|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|99.9|2.84|8.05||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||8.05|2.84|<0.0001
91547946|NCT03649659|182976844|SUPERIORITY||Odds Ratio (OR)|5.84|||<|0.0001|TWO_SIDED|99.9|3.59|9.51||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||9.51|3.59|<0.0001
91547947|NCT03649659|182976845|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8942|TWO_SIDED|99.9|0.25|3.54||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||3.54|0.25|0.8942
91547948|NCT05908344|182976870|OTHER|Effect size determination|Cohen's d|-0.24|||||TWO_SIDED|||||||||Comparison for NREM1 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design||||
91547949|NCT05908344|182976870|OTHER|Effect size determination|Cohen's d|-0.15|||||TWO_SIDED|||||||||Comparison for NREM2 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547950|NCT05908344|182976870|OTHER|Effect size determination|Cohen's d|0.69|||||TWO_SIDED|||||||||Comparison for NREM3 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547951|NCT05908344|182976870|OTHER|Effect size determination|Cohen's d|-0.82|||||TWO_SIDED|||||||||Comparison for REM minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547952|NCT05908344|182976871|OTHER|Effect size determination|Cohen's d|-0.04|||||TWO_SIDED|||||||||Comparison for NREM1 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547953|NCT05908344|182976871|OTHER|Effect size determination|Cohen's d|0.24|||||TWO_SIDED|||||||||Comparison for NREM2 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547954|NCT05908344|182976871|OTHER|Effect size determination|Cohen's d|0.8|||||TWO_SIDED|||||||||Comparison for NREM3 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547955|NCT05908344|182976871|OTHER|Effect size determination|Cohen's d|-0.78|||||TWO_SIDED|||||||||Comparison for REM percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547956|NCT05908344|182976872|OTHER|Effect size determination|Cohen's d|0.11|||||TWO_SIDED|||||||||Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
91547957|NCT04856163|182976897|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
91547958|NCT04856163|182976898|SUPERIORITY|||||||0.21|||||||discrete-time survival model|||||||0.21
91547959|NCT04856163|182976899|SUPERIORITY|||||||0.28|||||||Regression, Logistic|||||||0.28
91547960|NCT04856163|182976900|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
91547961|NCT02515773|182976918|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
91547962|NCT02515773|182976919|SUPERIORITY||Mean Difference (Net)|0.07||||0.044|TWO_SIDED||||||ANCOVA|||||||0.044
91547963|NCT02515773|182976920|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
91547964|NCT02515773|182976921|SUPERIORITY||Mean Difference (Net)|0.09||||0.041|TWO_SIDED||||||ANCOVA|||||||0.041
91547965|NCT04072380|182976929|SUPERIORITY|||||||0.024||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.024
91547966|NCT04072380|182976930|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.009
91547967|NCT04072380|182976931|SUPERIORITY|||||||0.734||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.734
91547968|NCT04072380|182976932|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91547969|NCT04072380|182976933|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91547970|NCT01552473|182976940|OTHER|This is a functional Magnetic Resonance Imaging analysis. We aimed to determine whether functional brain network connectivity was equivalent between the two intervention arms prior to the interventions beginning. This was computed in significant numbers of connections between the two groups.|pNBS|0.0001||||0.01|TWO_SIDED|||||This is a p-value that is used in Network Based Statistics analysis for resting-state functional brain network data.|Network Based Statistics analysis|This is a type of statistical analysis used to test for group differences among functional connectivity levels between two or more groups.|This analysis evaluated monotonic changes from time point 1 (pre-intervention) to time points 2 (immediate post-intervention) and 3 (12 weeks post-intervention) that may have occurred between the SMART and BHW groups.|A network-based statistics analysis was carried out to determine brain connectivity differences observed at time points two (initial post-intervention testing phase) and three (the final post-intervention phase) occurring three months post-intervention.||||0.01
91547971|NCT02132936|182976996|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55|||<|0.001|TWO_SIDED|95.0|1.46|4.46|||Mantel Haenszel|||"Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing PGA values."||4.46|1.46|<0.001
91547972|NCT02132936|182976997|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18|||=|0.001|TWO_SIDED|95.0|1.37|3.47|||Mantel Haenszel|||"Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing data."||3.47|1.37|=0.001
91547973|NCT02132936|182976998|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
91547974|NCT02132936|182976999|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||<0.001
91547975|NCT02132936|182977000|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.33|TWO_SIDED||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||=0.33
91547976|NCT02111798|182977044|SUPERIORITY|||||||0.889|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.889
91547977|NCT02111798|182977045|SUPERIORITY|||||||0.605|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.605
91547978|NCT05722704|182977093|SUPERIORITY||Median Difference (Net)|0.118|STANDARD_DEVIATION|0.05||0.986|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.986
91547979|NCT05722704|182977094|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_DEVIATION|0.05|<|0.118|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.118
91547980|NCT05722704|182977095|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.225|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.225
91547981|NCT05722704|182977096|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.424|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.424
91547982|NCT04323137|182977103|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||"This analysis compared all groups that were informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm) to control patients who were not sent a message.~Null hypothesis: informing patients they are high risk for flu and flu-related complications does not increase flu vaccination rate; Alternative hypothesis: informing patients they are high risk for flu and flu-related complications increases flu vaccination rate"||||0.0035
91547983|NCT04323137|182977103|SUPERIORITY|||||||0.613||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on medical records messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on medical records. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.613
91547984|NCT04323137|182977103|SUPERIORITY|||||||0.889||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||0.889
91765729|NCT03187132|183420463|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.27||0.612|TWO_SIDED|95.0|-1.84|3.12|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||3.12|-1.84|.612
91765730|NCT03187132|183420464|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.58||0.87|TWO_SIDED|95.0|-5.51|4.66|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||4.66|-5.51|.87
91765731|NCT03187132|183420464|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.274||0.787|TWO_SIDED|95.0|-0.54|0.54|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.54|-.54|.787
91765732|NCT03187132|183420464|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.569|TWO_SIDED|95.0|-0.88|0.48|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.48|-.88|.569
91765733|NCT03187132|183420465|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.467|TWO_SIDED|95.0|-0.23|0.49|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.49|-.23|.467
91765734|NCT03187132|183420466|SUPERIORITY||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.986||0.852|TWO_SIDED|95.0|0.07|9.07|||Regression, Logistic|||We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.||9.07|.07|.852
91765735|NCT02707146|183420468|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|||||Chi-squared|||||||
91765736|NCT00123123|183420525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0|||||ANOVA|||A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.||||0.6750
91765737|NCT02073682|183420527|NON_INFERIORITY|Edoxaban Group was considered non-inferior to the Dalteparin Group if the upper limit of the 2-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] Edoxaban Group to Dalteparin Group) was less than 1.5.|Cox Proportional Hazard|0.97||||0.0056|TWO_SIDED|95.0|0.696|1.359|||Cox proportional hazard|||||1.359|0.696|0.0056
91765738|NCT02073682|183420527|SUPERIORITY|The hazard ratio (HR), two-sided confidence interval (CI) and p-value are based on the Cox proportional hazard model including treatment and the two stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||||||0.8712|||||||Cox proportional hazard|||||||0.8712
91765739|NCT02073682|183420528|SUPERIORITY||Hazard Ratio (HR)|2.0||||0.0254|TWO_SIDED|95.0|1.089|3.657|||Regression, Cox|||The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||3.657|1.089|0.0254
91765740|NCT02073682|183420529|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0931|TWO_SIDED|95.0|0.476|1.059|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.059|0.476|0.0931
91547985|NCT04323137|182977103|SUPERIORITY|||||||0.714||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk based on medical records and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk based on medical records and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.714
91547986|NCT04323137|182977104|SUPERIORITY|||||||0.181||||||This p-value is from the same regression as the top 10% risk vs. top 3% risk contrast (analysis 2).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same risk level who were sent messages with a vague verbal (high risk) vs. specific numeric (top 10%) risk framing.~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.181
91547987|NCT04323137|182977104|SUPERIORITY|||||||0.301||||||This p-value is from the same regression as the high risk vs. top 10% risk contrast (analysis 1).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same numeric risk phrasing are differentially affected due to different specific risk levels (3% vs. 10%).~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.301
91547988|NCT05563246|182977121|SUPERIORITY||LS Mean Difference (Final Values)|-47.61|||<|0.001|TWO_SIDED|95.0|-57.68|-35.14|||Mixed Models Analysis|||||-35.14|-57.68|<.001
91547989|NCT05563246|182977121|SUPERIORITY||LS Mean Difference (Final Values)|-81.66|||<|0.001|TWO_SIDED|95.0|-84.62|-78.13|||Mixed Models Analysis|||||-78.13|-84.62|<.001
91547990|NCT05563246|182977121|SUPERIORITY||LS Mean Difference (Final Values)|-85.77|||<|0.001|TWO_SIDED|95.0|-88.03|-83.09|||Mixed Models Analysis|||||-83.09|-88.03|<.001
91765741|NCT02073682|183420530|SUPERIORITY||Cox Proportional Hazard|0.56||||0.0394|TWO_SIDED|95.0|0.318|0.972|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||0.972|0.318|0.0394
91547991|NCT05563246|182977122|SUPERIORITY||LS Mean Difference (Final Values)|-40.38|||<|0.001|TWO_SIDED|95.0|-50.45|-28.27|||Mixed Models Analysis|||||-28.27|-50.45|<.001
91547992|NCT05563246|182977122|SUPERIORITY||LS Mean Difference (Final Values)|-69.95|||<|0.001|TWO_SIDED|95.0|-74.23|-64.96|||Mixed Models Analysis|||||-64.96|-74.23|<.001
91547993|NCT05563246|182977122|SUPERIORITY||LS Mean Difference (Final Values)|-68.9|||<|0.001|TWO_SIDED|95.0|-73.27|-63.81|||Mixed Models Analysis|||||-63.81|-73.27|<.001
91547994|NCT05563246|182977123|SUPERIORITY||Risk Difference (RD)|58.15|||<|0.001|TWO_SIDED|95.0|40.3|75.99|||Regression, Logistic|||||75.99|40.30|<.001
91547995|NCT05563246|182977123|SUPERIORITY||Risk Difference (RD)|89.87|||<|0.001|TWO_SIDED|95.0|81.54|98.2|||Regression, Logistic|||||98.20|81.54|<.001
91547996|NCT05563246|182977123|SUPERIORITY||Risk Difference (RD)|90.71|||<|0.001|TWO_SIDED|95.0|82.8|98.62|||Regression, Logistic|||||98.62|82.80|<.001
91547997|NCT05563246|182977124|SUPERIORITY||Risk Difference (RD)|35.18|||<|0.001|TWO_SIDED|95.0|18.9|51.46|||Regression, Logistic|||||51.46|18.90|<.001
91547998|NCT05563246|182977124|SUPERIORITY||Risk Difference (RD)|78.18|||<|0.001|TWO_SIDED|95.0|67.7|88.65|||Regression, Logistic|||||88.65|67.70|<.001
91547999|NCT05563246|182977124|SUPERIORITY||Risk Difference (RD)|73.62|||<|0.001|TWO_SIDED|95.0|63.65|83.58|||Regression, Logistic|||||83.58|63.65|<.001
91548000|NCT05563246|182977125|SUPERIORITY||LS Mean Difference (Final Values)|-8.94||||0.11|TWO_SIDED|95.0|-18.84|2.17|||Mixed Models Analysis|||||2.17|-18.84|0.110
91548001|NCT05563246|182977125|SUPERIORITY||LS Mean Difference (Final Values)|-13.05||||0.004|TWO_SIDED|95.0|-20.92|-4.4|||Mixed Models Analysis|||||-4.40|-20.92|0.004
91548002|NCT05563246|182977125|SUPERIORITY||LS Mean Difference (Final Values)|-16.13|||<|0.001|TWO_SIDED|95.0|-23.69|-7.84|||Mixed Models Analysis|||||-7.84|-23.69|<.001
91765742|NCT02073682|183420531|SUPERIORITY||Cox Proportional Hazard|0.9||||0.7324|TWO_SIDED|95.0|0.502|1.624|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.624|0.502|0.7324
91765743|NCT02073682|183420532|SUPERIORITY||Cox Proportional Hazard|1.56||||0.4873|TWO_SIDED|95.0|0.444|5.505|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||5.505|0.444|0.4873
91548003|NCT05563246|182977126|SUPERIORITY||LS Mean Difference (Final Values)|35.27||||0.131|TWO_SIDED|95.0|-8.63|100.27|||Mixed Models Analysis|||||100.27|-8.63|0.131
91548004|NCT05563246|182977126|SUPERIORITY||LS Mean Difference (Final Values)|8.32||||0.627|TWO_SIDED|95.0|-21.62|49.7|||Mixed Models Analysis|||||49.70|-21.62|0.627
91548005|NCT05563246|182977126|SUPERIORITY||LS Mean Difference (Final Values)|-6.08||||0.701|TWO_SIDED|95.0|-31.89|29.51|||Mixed Models Analysis|||||29.51|-31.89|0.701
91548006|NCT03332017|182977133|SUPERIORITY|||||||0.0017|||||||Cochran-Mantel-Haenszel|P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.||||||0.0017
91548007|NCT03843151|182977178|OTHER||Ratio|192.67|||||TWO_SIDED|90.0|175.19|211.89|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 14.9."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||211.89|175.19|
91548008|NCT03843151|182977179|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 21.7."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
91765744|NCT02073682|183420533|SUPERIORITY||Cox Proportional Hazard|1.08||||0.4199|TWO_SIDED|95.0|0.898|1.293|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.293|0.898|0.4199
91765745|NCT04435366|183420541|SUPERIORITY||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.02||0.0064|TWO_SIDED|95.0|0.016|0.096||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.||0.096|0.016|0.0064
91765746|NCT04435366|183420542|SUPERIORITY||Least Squares Mean Difference|0.362|STANDARD_ERROR_OF_MEAN|0.15||0.0165|TWO_SIDED|95.0|0.066|0.657||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||0.657|0.066|0.0165
91765747|NCT04435366|183420542|SUPERIORITY||Least Squares Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.152||0.0015|TWO_SIDED|95.0|0.189|0.788||Nominal p-value was used for the comparison between avacincaptad pegol and sham versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).||0.788|0.189|0.0015
91765748|NCT04435366|183420543|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.58|TWO_SIDED|95.0|-3.79|2.12||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||2.12|-3.79|0.58
91765749|NCT04435366|183420544|SUPERIORITY||Least Squares Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|1.68||0.38|TWO_SIDED|95.0|-4.79|1.81||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||1.81|-4.79|0.38
91765750|NCT04435366|183420546|SUPERIORITY||Least square mean difference|-0.712|STANDARD_ERROR_OF_MEAN|1.33||0.5929|TWO_SIDED|95.0|-3.326|1.903|||MMRM|||||1.903|-3.326|0.5929
91765751|NCT04435366|183420548|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6424|TWO_SIDED|95.0|0.57|1.42|||Log Rank|||||1.42|0.57|0.6424
91765752|NCT01687296|183420549|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.46||||0.931|TWO_SIDED|95.0|-9.85|10.76|||ANCOVA|||250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.||10.76|-9.85|0.931
91765753|NCT01687296|183420550|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.5||||0.922|TWO_SIDED|95.0|-9.64|10.65|||ANCOVA|||||10.65|-9.64|0.922
91765754|NCT01687296|183420551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.822|TWO_SIDED|95.0|-9.02|11.34|||ANCOVA|||||11.34|-9.02|0.822
91765755|NCT01687296|183420552|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for day-time symptom score||||0.717
91765756|NCT01687296|183420552|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for night-time symptom score||||0.683
91765757|NCT01687296|183420553|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Wilcoxon rank sum test|||||||0.996
91765758|NCT01687296|183420554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.348|TWO_SIDED|95.0|-0.135|0.048|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 5||0.048|-0.135|0.348
91765759|NCT01687296|183420554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004||||0.914|TWO_SIDED|95.0|-0.074|0.083|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 8||0.083|-0.074|0.914
91765760|NCT01687296|183420554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.067||||0.276|TWO_SIDED|95.0|-0.187|0.054|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 5||0.054|-0.187|0.276
91765761|NCT01687296|183420554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.384|TWO_SIDED|95.0|-0.126|0.049|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 8||0.049|-0.126|0.384
91765762|NCT01687296|183420555|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 5||||0.507
91765763|NCT01687296|183420555|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 8||||0.700
91765764|NCT01687296|183420556|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for participant/parent global evaluation||||0.633
91765765|NCT01687296|183420556|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for investigator global evaluation||||0.323
91765766|NCT04152772|183420563|SUPERIORITY|||||||0.02||||||Significant Group (3 levels) by Stimulus (CS- vs CS+ extinguished) interaction. A priori threshold for statistical significance was set at p\<0.05.|Mixed Models Analysis|||Comparison of groups (3) on skin conductance reactivity to the previously extinguished stimulus versus never conditioned stimulus during extinction recall||||0.02
91765767|NCT05963022|183420564|SUPERIORITY||LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.76|-1.07|||ANCOVA|||||-1.07|-1.76|<0.001
91765768|NCT05963022|183420564|SUPERIORITY||LS Mean Difference|-0.98|||<|0.001|TWO_SIDED|95.0|-1.34|-0.63|||ANCOVA|||||-0.63|-1.34|<0.001
91548009|NCT03843151|182977180|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 13.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
91548010|NCT04229992|182977186|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo."||||<0.05
91548011|NCT04229992|182977187|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo"||||<0.05
91548012|NCT05178316|182977188|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|2.175|=|0.8862|TWO_SIDED|95.0|-3.98|4.6|||Mixed Models Analysis|||||4.60|-3.98|=0.8862
91548013|NCT05178316|182977188|SUPERIORITY||Least squares mean difference|-0.74|STANDARD_ERROR_OF_MEAN|1.817|=|0.6832|TWO_SIDED|95.0|-4.32|2.84|||Mixed Models Analysis|||||2.84|-4.32|=0.6832
91548014|NCT05178316|182977189|SUPERIORITY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.204|=|0.4522|TWO_SIDED|95.0|-0.55|0.25|||Mixed Models Analysis|||||0.25|-0.55|=0.4522
91548015|NCT05178316|182977189|SUPERIORITY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.169|=|0.2032|TWO_SIDED|95.0|-0.55|0.12|||Mixed Models Analysis|||||0.12|-0.55|=0.2032
91548016|NCT05178316|182977190|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.165|=|0.717|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|||||0.26|-0.38|=0.7170
91548017|NCT05178316|182977190|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.137|=|0.2423|TWO_SIDED|95.0|-0.43|0.11|||Mixed Models Analysis|||||0.11|-0.43|=0.2423
91765769|NCT05963022|183420564|SUPERIORITY||LS Mean Difference|-1.26|||<|0.001|TWO_SIDED|95.0|-1.61|-0.92|||ANCOVA|||||-0.92|-1.61|<0.001
91765770|NCT05963022|183420565|SUPERIORITY||Odds Ratio (OR)|17.04|||<|0.001|TWO_SIDED|95.0|5.62|51.73|||Regression, Logistic|||||51.73|5.62|<0.001
91765771|NCT05963022|183420565|SUPERIORITY||Odds Ratio (OR)|7.51|||<|0.001|TWO_SIDED|95.0|2.77|20.37|||Regression, Logistic|||||20.37|2.77|<0.001
91548018|NCT04169373|182977193|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|17.9|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.||34.9|17.9|<0.0001
91548019|NCT04169373|182977194|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP status.|Response Rate Difference = Upadacitinib - Placebo|"Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.~Binary endpoints in Study 2 were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the main stratification factor of positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP \> ULN vs MRI-positive and hsCRP ≤ ULN vs MRI-negative and hsCRP \> ULN)."||32.3|12.1|<0.0001
91548020|NCT04169373|182977194|OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.7|4.5|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.5|1.7|
91548021|NCT04169373|182977195|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Least Squares (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.85|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.85|-1.20|<0.0001
91765772|NCT05963022|183420565|SUPERIORITY||Odds Ratio (OR)|7.24|||<|0.001|TWO_SIDED|95.0|2.74|19.14|||Regression, Logistic|||||19.14|2.74|<0.001
91765773|NCT05963022|183420566|SUPERIORITY||LS Mean Difference|-24.8|||<|0.001|TWO_SIDED|95.0|-33.3|-16.3|||ANCOVA|||||-16.3|-33.3|<0.001
91765774|NCT05963022|183420566|SUPERIORITY||LS Mean Difference|-24.6|||<|0.001|TWO_SIDED|95.0|-33.2|-15.9|||ANCOVA|||||-15.9|-33.2|<0.001
91765775|NCT05963022|183420566|SUPERIORITY||LS Mean Difference|-25.2|||<|0.001|TWO_SIDED|95.0|-33.7|-16.7|||ANCOVA|||||-16.7|-33.7|<0.001
91765776|NCT05963022|183420567|SUPERIORITY||Odds Ratio (OR)|25.61|||<|0.001|TWO_SIDED|95.0|8.7|75.36|||Regression, Logistic|||||75.36|8.70|<0.001
91765777|NCT05963022|183420567|SUPERIORITY||Odds Ratio (OR)|7.25|||<|0.001|TWO_SIDED|95.0|2.88|18.25|||Regression, Logistic|||||18.25|2.88|<0.001
91765778|NCT05963022|183420567|SUPERIORITY||Odds Ratio (OR)|10.95|||<|0.001|TWO_SIDED|95.0|4.23|28.34|||Regression, Logistic|||||28.34|4.23|<0.001
91765779|NCT05963022|183420568|SUPERIORITY||LS Mean Difference|-4.8|||<|0.001|TWO_SIDED|95.0|-6.7|-2.9|||ANCOVA|||||-2.9|-6.7|<0.001
91765780|NCT05963022|183420568|SUPERIORITY||LS Mean Difference|-4.2|||<|0.001|TWO_SIDED|95.0|-6.2|-2.3|||ANCOVA|||||-2.3|-6.2|<0.001
91765781|NCT05963022|183420568|SUPERIORITY||LS Mean Difference|-7.3|||<|0.001|TWO_SIDED|95.0|-9.3|-5.4|||ANCOVA|||||-5.4|-9.3|<0.001
91548022|NCT04169373|182977196|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.47|-2.33|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.33|-5.47|<0.0001
91548023|NCT04169373|182977197|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|18.0|34.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||34.8|18.0|<0.0001
91548024|NCT04169373|182977198|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.9|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||36.3|17.9|<0.0001
91548025|NCT04169373|182977199|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9|||<|0.0001|TWO_SIDED|95.0|6.0|15.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||15.8|6.0|<0.0001
91548026|NCT04169373|182977200|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.11|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.11|-1.96|<0.0001
91548027|NCT04169373|182977201|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.14|<0.0001
91548028|NCT04169373|182977202|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|34.0|||<|0.0001|TWO_SIDED|95.0|26.2|41.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||41.8|26.2|<0.0001
91548029|NCT04169373|182977203|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.55|-0.8|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.80|-1.55|<0.0001
91765782|NCT05963022|183420569|SUPERIORITY||Odds Ratio (OR)|76.62||||0.003|TWO_SIDED|95.0|4.4|1333.29|||Regression, Logistic|||||1333.29|4.40|0.003
91765783|NCT05963022|183420569|SUPERIORITY||Odds Ratio (OR)|49.36|||<|0.001|TWO_SIDED|95.0|2.8|868.67|||Regression, Logistic|||||868.67|2.80|<0.001
91765784|NCT05963022|183420569|SUPERIORITY||Odds Ratio (OR)|118.22|||<|0.001|TWO_SIDED|95.0|6.8|2055.04|||Regression, Logistic|||||2055.04|6.80|<0.001
91765785|NCT05963022|183420570|SUPERIORITY||LS Mean Difference|-44.5|||<|0.001|TWO_SIDED|95.0|-57.5|-31.5|||Mixed Models Analysis|||||-31.5|-57.5|<0.001
91765786|NCT05963022|183420570|SUPERIORITY||LS Mean Difference|-44.3|||<|0.001|TWO_SIDED|95.0|-57.6|-31.1|||Mixed Models Analysis|||||-31.1|-57.6|<0.001
91765787|NCT05963022|183420570|SUPERIORITY||LS Mean Difference|-46.9|||<|0.001|TWO_SIDED|95.0|-60.1|-33.7|||Mixed Models Analysis|||||-33.7|-60.1|<0.001
91765788|NCT05963022|183420571|SUPERIORITY||Odds Ratio (OR)|18.19|||<|0.001|TWO_SIDED|95.0|5.27|62.73|||Regression, Logistic|||||62.73|5.27|<0.001
91765789|NCT05963022|183420571|SUPERIORITY||Odds Ratio (OR)|30.96|||<|0.001|TWO_SIDED|95.0|8.87|108.05|||Regression, Logistic|||||108.05|8.87|<0.001
91765790|NCT05963022|183420571|SUPERIORITY||Odds Ratio (OR)|73.42|||<|0.001|TWO_SIDED|95.0|19.36|278.4|||Regression, Logistic|||||278.40|19.36|<0.001
91765791|NCT05963022|183420572|SUPERIORITY||Odds Ratio (OR)|39.04||||0.011|TWO_SIDED|95.0|2.29|664.36|||Regression, Logistic|||||664.36|2.29|0.011
91765792|NCT05963022|183420572|SUPERIORITY||Odds Ratio (OR)|56.34||||0.005|TWO_SIDED|95.0|3.34|949.59|||Regression, Logistic|||||949.59|3.34|0.005
91765793|NCT05963022|183420572|SUPERIORITY||Odds Ratio (OR)|127.52|||<|0.001|TWO_SIDED|95.0|7.58|2145.42|||Regression, Logistic|||||2145.42|7.58|<0.001
91765794|NCT05963022|183420573|SUPERIORITY||Odds Ratio (OR)|13.86||||0.077|TWO_SIDED|95.0|0.75|254.78|||Regression, Logistic|||||254.78|0.75|0.077
91765795|NCT05963022|183420573|SUPERIORITY||Odds Ratio (OR)|15.65||||0.062|TWO_SIDED|95.0|0.87|281.74|||Regression, Logistic|||||281.74|0.87|0.062
91765796|NCT05963022|183420573|SUPERIORITY||Odds Ratio (OR)|66.69||||0.004|TWO_SIDED|95.0|3.9|1140.13|||Regression, Logistic|||||1140.13|3.90|0.004
91765797|NCT02501590|183420574|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91765798|NCT00945282|183420600|SUPERIORITY||Mean Difference (Final Values)|-0.932||||0.042|TWO_SIDED|95.0|-1.812|-0.053|||ANCOVA|||||-0.053|-1.812|0.042
91765799|NCT00945282|183420601|SUPERIORITY||Mean Difference (Final Values)|-0.413||||0.221|TWO_SIDED|95.0|-1.173|0.347|||ANCOVA|||||0.347|-1.173|0.221
91548030|NCT04169373|182977204|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||19.0|7.4|<0.0001
91548031|NCT04169373|182977205|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.24|-3.90|<0.0001
91548032|NCT04169373|182977206|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.47|<0.0001
91548033|NCT04169373|182977207|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.46|-0.18|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.18|-0.46|<0.0001
91548034|NCT04169373|182977208|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.9|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.9|-2.0|<0.0001
91548035|NCT04169373|182977209|OTHER||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.5|-2.12||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.12|-4.50|<0.0001
91765800|NCT00945282|183420602|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is the value for GSK2248761 30 mg, at Day 1 to Day 8|Mixed Models Analysis|||Day 1 to Day 8||||<0.0001
91765801|NCT00945282|183420602|SUPERIORITY_OR_OTHER|||||||0.6922||||||The p-value is the value for placebo, at Day 1 to Day 8|Mixed Models Analysis|||Placebo, Day 1 to Day 8||||0.6922
91765802|NCT01702558|183420754|SUPERIORITY||Difference in Response Rates|8.2||||0.336|TWO_SIDED|90.0|-4.5|20.9|||Fisher Exact||90% CI was estimated using Hauck-Anderson approach.|||20.9|-4.5|0.336
91765803|NCT03259087|183420818|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.07|1.47|||||GMR is ratio of Experimental Group / Healthy Group|||1.47|1.07|
91765804|NCT03259087|183420818|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.7|||||TWO_SIDED|90.0|1.42|2.02|||||GMR is ratio of Experimental Group / Healthy Group|||2.02|1.42|
91765805|NCT03259087|183420818|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.98|||||TWO_SIDED|90.0|2.2|4.04|||||GMR is ratio of Experimental Group / Healthy Group|||4.04|2.20|
91765806|NCT03259087|183420819|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.06|1.46|||||GMR is ratio of Experimental Group / Healthy Group|||1.46|1.06|
91765807|NCT03259087|183420819|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.68|||||TWO_SIDED|90.0|1.41|1.99|||||GMR is ratio of Experimental Group / Healthy Group|||1.99|1.41|
91765808|NCT03259087|183420819|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.91|||||TWO_SIDED|90.0|2.17|3.9|||||GMR is ratio of Experimental Group / Healthy Group|||3.90|2.17|
91548036|NCT04169373|182977210|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.45|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.45|-0.85|<0.0001
91548037|NCT04169373|182977211|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.06|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.04|||ANCOVA|ANCOVA model including treatment, main stratification factor, treatment and stratification factor interaction and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.04|-4.08|<0.0001
91765809|NCT03259087|183420820|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|1.04|1.4|||||GMR is ratio of Experimental Group / Healthy Group|||1.40|1.04|
91765810|NCT03259087|183420820|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.59|||||TWO_SIDED|90.0|1.36|1.86|||||GMR is ratio of Experimental Group / Healthy Group|||1.86|1.36|
91765811|NCT03259087|183420820|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.32|||||TWO_SIDED|90.0|1.82|2.97|||||GMR is ratio of Experimental Group / Healthy Group|||2.97|1.82|
91765812|NCT03259087|183420821|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.84|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.84|
91765813|NCT03259087|183420821|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.9|1.18|||||GMR is ratio of Experimental Group / Healthy Group|||1.18|0.90|
91765814|NCT03259087|183420821|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.11|||||TWO_SIDED|90.0|0.95|1.29|||||GMR is ratio of Experimental Group / Healthy Group|||1.29|0.95|
91765815|NCT03259087|183420823|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.8|||||TWO_SIDED|90.0|0.68|0.94|||||GMR is ratio of Experimental Group / Healthy Group|||0.94|0.68|
91765816|NCT03259087|183420823|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.59|||||TWO_SIDED|90.0|0.49|0.7|||||GMR is ratio of Experimental Group / Healthy Group|||0.70|0.49|
91765817|NCT03259087|183420823|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.34|||||TWO_SIDED|90.0|0.25|0.45|||||GMR is ratio of Experimental Group / Healthy Group|||0.45|0.25|
91765818|NCT03259087|183420827|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.97|||||TWO_SIDED|90.0|3.26|4.82|||||GMR is ratio of Experimental Group / Healthy Group|||4.82|3.26|
91765819|NCT03259087|183420827|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.58|||||TWO_SIDED|90.0|1.3|1.92|||||GMR is ratio of Experimental Group / Healthy Group|||1.92|1.30|
91765820|NCT03259087|183420828|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.63|||||TWO_SIDED|90.0|3.03|4.36|||||GMR is ratio of Experimental Group / Healthy Group|||4.36|3.03|
91765821|NCT03259087|183420828|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.46|||||TWO_SIDED|90.0|1.22|1.75|||||GMR is ratio of Experimental Group / Healthy Group|||1.75|1.22|
91765822|NCT03259087|183420829|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.61|||||TWO_SIDED|90.0|2.23|3.06|||||GMR is ratio of Experimental Group / Healthy Group|||3.06|2.23|
91765823|NCT03259087|183420829|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.95|1.25|||||GMR is ratio of Experimental Group / Healthy Group|||1.25|0.95|
91765824|NCT03259087|183420830|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.98|||||TWO_SIDED|90.0|0.84|1.14|||||GMR is ratio of Experimental Group / Healthy Group|||1.14|0.84|
91765825|NCT03259087|183420830|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
91765826|NCT03259087|183420831|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.85|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.85|
91765827|NCT03259087|183420831|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
91765828|NCT03259087|183420832|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.25|||||TWO_SIDED|90.0|0.21|0.31|||||GMR is ratio of Experimental Group / Healthy Group|||0.31|0.21|
91765829|NCT03259087|183420832|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.63|||||TWO_SIDED|95.0|0.52|0.77|||||GMR is ratio of Experimental Group / Healthy Group|||0.77|0.52|
91765830|NCT03259087|183420836|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
91765831|NCT03259087|183420836|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
91765832|NCT03259087|183420836|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
91765833|NCT03259087|183420837|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.75|||||TWO_SIDED|90.0|0.57|0.98|||||GMR is ratio of Experimental Group / Healthy Group|||0.98|0.57|
91765834|NCT03259087|183420837|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.4|||||TWO_SIDED|90.0|0.31|0.53|||||GMR is ratio of Experimental Group / Healthy Group|||0.53|0.31|
91765835|NCT03259087|183420837|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.13|||||TWO_SIDED|90.0|0.08|0.22|||||GMR is ratio of Experimental Group / Healthy Group|||0.22|0.08|
91765836|NCT03259087|183420838|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
91765837|NCT03259087|183420838|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
91765838|NCT03259087|183420838|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
91548038|NCT04169373|182977212|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|20.1||||0.0001|TWO_SIDED|95.0|10.1|30.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.1|10.1|0.0001
91548039|NCT04169373|182977212|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.6|4.2|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.2|1.6|
91548040|NCT04169373|182977213|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|8.8||||0.0063|TWO_SIDED|95.0|2.5|15.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||15.2|2.5|0.0063
91548041|NCT04169373|182977213|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|1.3|7.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||7.0|1.3|
91548042|NCT04169373|182977214|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.92||||0.0004|TWO_SIDED|95.0|-1.42|-0.41|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.41|-1.42|0.0004
91548043|NCT04169373|182977215|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.12||||0.0001|TWO_SIDED|95.0|-1.68|-0.55|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.55|-1.68|0.0001
91548044|NCT04169373|182977216|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|23.8|||<|0.0001|TWO_SIDED|95.0|14.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|14.2|<0.0001
91548045|NCT04169373|182977216|OTHER||Odds Ratio (OR)|3.2|||||TWO_SIDED|95.0|1.9|5.4|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.4|1.9|
91548046|NCT04169373|182977217|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9||||0.0035|TWO_SIDED|95.0|3.6|18.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||18.3|3.6|0.0035
91548047|NCT04169373|182977217|OTHER||Odds Ratio (OR)|2.7|||||TWO_SIDED|95.0|1.3|5.6|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.6|1.3|
91548048|NCT04169373|182977218|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.68|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.60|<0.0001
91548049|NCT04169373|182977219|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-2.23|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.21|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.21|-3.26|<0.0001
91548050|NCT04169373|182977220|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.78|||<|0.0001|TWO_SIDED|95.0|-2.56|-1.0|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.00|-2.56|<0.0001
91548051|NCT04169373|182977221|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.8|||<|0.0001|TWO_SIDED|95.0|12.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|12.2|<0.0001
91548052|NCT04169373|182977221|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|1.6|4.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.0|1.6|
91548053|NCT04169373|182977222|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.1||||0.1781|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|ANCOVA model including treatment and main stratification factor MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||0.05|-0.25|0.1781
91548054|NCT04169373|182977223|OTHER||LS Mean Difference|-0.7||||0.0193|TWO_SIDED|95.0|-1.3|-0.1|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.1|-1.3|0.0193
91548055|NCT04169373|182977224|SUPERIORITY||Response Rate Difference|20.1||||0.0003|TWO_SIDED|95.0|9.3|30.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.9|9.3|0.0003
91548056|NCT04169373|182977225|OTHER||LS Mean Difference|-1.13||||0.0206|TWO_SIDED|95.0|-2.08|-0.17||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and main stratification factors MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.17|-2.08|0.0206
91548057|NCT04169373|182977227|SUPERIORITY||Response Rate Difference|17.6||||0.0004|TWO_SIDED|95.0|7.9|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||27.3|7.9|0.0004
91548058|NCT04169373|182977228|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|13.2|30.6||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.6|13.2|<0.0001
91548059|NCT04169373|182977229|SUPERIORITY||Response Rate Difference|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.7|12.4|<0.0001
91548060|NCT04610892|182977230|SUPERIORITY||Least Square Mean difference|-8.3797||||0.065||90.0|-17.498|0.7387||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||0.7387|-17.4980|0.065
91765839|NCT01623115|183420875|SUPERIORITY_OR_OTHER||LS mean difference|-57.9|||<|0.0001|TWO_SIDED|95.0|-63.3|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-52.6|-63.3|<0.0001
91548061|NCT04610892|182977230|SUPERIORITY||Least Square Mean difference|2.3915||||0.747||90.0|-3.5338|8.3167||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||8.3167|-3.5338|0.747
91548062|NCT04610892|182977230|SUPERIORITY||Least Square Mean difference|0.5766||||0.563||90.0|-5.4389|6.5921||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.5921|-5.4389|0.563
91548063|NCT04610892|182977230|SUPERIORITY||Least Square Mean difference|1.5204||||0.685||90.0|-3.6657|6.7064||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.7064|-3.6657|0.685
91548064|NCT04610892|182977231|SUPERIORITY||Geometric LS mean ratio estimate|1.12||||0.854||90.0|0.94|1.33||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.33|0.94|0.854
91548065|NCT04610892|182977231|SUPERIORITY||Geometric LS mean ratio estimate|1.06||||0.79||90.0|0.94|1.18||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.18|0.94|0.790
91548066|NCT04610892|182977231|SUPERIORITY||Geometric LS mean ratio estimate|1.0||||0.498||90.0|0.89|1.12||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.12|0.89|0.498
91548067|NCT04610892|182977231|SUPERIORITY||Geometric LS mean ratio estimate|1.03||||0.678||90.0|0.93|1.13||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.13|0.93|0.678
91548068|NCT04610892|182977232|SUPERIORITY||Least Squares mean difference|-1.44||||0.99||90.0|-2.44|-0.43||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.43|-2.44|0.990
91548069|NCT04610892|182977232|SUPERIORITY||Least Squares mean difference|-0.21||||0.697||90.0|-0.87|0.45||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.45|-0.87|0.697
91765840|NCT01623115|183420876|SUPERIORITY_OR_OTHER||LS mean difference|-58.1|||<|0.0001|TWO_SIDED|95.0|-63.5|-52.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-52.7|-63.5|<0.0001
91548070|NCT04610892|182977232|SUPERIORITY||Least Squares mean difference|-0.42||||0.849||90.0|-1.08|0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.25|-1.08|0.849
91548071|NCT04610892|182977232|SUPERIORITY||Least Squares mean difference|-0.31||||0.811||90.0|-0.89|0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.27|-0.89|0.811
91548072|NCT04610892|182977233|SUPERIORITY||Least Squares mean difference|-3.5||||0.972||90.0|-6.49|-0.5||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.50|-6.49|0.972
91548073|NCT04610892|182977233|SUPERIORITY||Least Squares mean difference|-1.1||||0.777||90.0|-3.49|1.3||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.30|-3.49|0.777
91548074|NCT04610892|182977233|SUPERIORITY||Least Squares mean difference|-0.32||||0.596||90.0|-2.54|1.89||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.89|-2.54|0.596
91548075|NCT04610892|182977233|SUPERIORITY||Least Squares mean difference|-0.63||||0.698||90.0|-2.64|1.38||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.38|-2.64|0.698
91548076|NCT04610892|182977234|SUPERIORITY||Least Squares mean difference|-1.29||||0.981||90.0|-2.32|-0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.27|-2.32|0.981
91548077|NCT04610892|182977234|SUPERIORITY||Least Squares mean difference|-0.8||||0.974||90.0|-1.47|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-1.47|0.974
91548078|NCT04610892|182977234|SUPERIORITY||Least Squares mean difference|-0.86||||0.983||90.0|-1.53|-0.2||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.20|-1.53|0.983
91548079|NCT04610892|182977234|SUPERIORITY||Least Squares mean difference|-0.83||||0.99||90.0|-1.42|-0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.25|-1.42|0.990
91548080|NCT04610892|182977235|SUPERIORITY||Least Squares mean difference|-2.14||||0.959||90.0|-4.16|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-4.16|0.959
91548081|NCT04610892|182977235|SUPERIORITY||Least Squares mean difference|-2.92||||0.998||90.0|-4.53|-1.31||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-1.31|-4.53|0.998
91548082|NCT04610892|182977235|SUPERIORITY||Least Squares mean difference|-1.35||||0.939||90.0|-2.79|0.09||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.09|-2.79|0.939
91548083|NCT04610892|182977235|SUPERIORITY||Least Squares mean difference|-1.94||||0.991||90.0|-3.27|-0.62||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.62|-3.27|0.991
91548084|NCT04610892|182977236|SUPERIORITY||Least Squares mean difference|-16.137||||0.077||90.0|-34.7829|2.5089||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.5089|-34.7829|0.077
91765841|NCT01623115|183420877|SUPERIORITY_OR_OTHER||LS mean difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-53.9|-44.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.5|-53.9|<0.0001
91548085|NCT04610892|182977236|SUPERIORITY||Least Squares mean difference|-0.5927||||0.468||90.0|-12.7267|11.5413||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||11.5413|-12.7267|0.468
91548086|NCT04610892|182977236|SUPERIORITY||Least Squares mean difference|-0.1767||||0.491||90.0|-12.4678|12.1144||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||12.1144|-12.4678|0.491
91548087|NCT04610892|182977236|SUPERIORITY||Least Squares mean difference|-0.393||||0.476||90.0|-11.0022|10.2162||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||10.2162|-11.0022|0.476
91548088|NCT04610892|182977237|SUPERIORITY||Least Squares mean difference|-4.3435||||0.136||90.0|-10.8637|2.1768||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.1768|-10.8637|0.136
91548089|NCT04610892|182977237|SUPERIORITY||Least Squares mean difference|-1.2369||||0.316||90.0|-5.4796|3.0059||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.0059|-5.4796|0.316
91548090|NCT04610892|182977237|SUPERIORITY||Least Squares mean difference|-0.7015||||0.394||90.0|-5.0096|3.6065||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.6065|-5.0096|0.394
91548091|NCT04610892|182977237|SUPERIORITY||Least Squares mean difference|-0.9799||||0.332||90.0|-4.6927|2.7329||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.7329|-4.6927|0.332
91548092|NCT04760678|182977329|OTHER|Fisher's exact test||||||0.107|||||||Fisher Exact|||||||0.107
91548093|NCT02226276|182977358|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91548094|NCT02226276|182977359|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91548095|NCT03675282|182977384|SUPERIORITY||Mean Difference (Final Values)|19.8||||0.66|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.66
91548096|NCT03675282|182977384|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.63|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.63
91548097|NCT03675282|182977384|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.99|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.99
91548098|NCT03675282|182977384|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.67|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.67
91548099|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.625||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part I (Baseline vs. 24 months)||||0.40
91548100|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-1.453||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part II (Baseline vs. 24 months)||||0.40
91548101|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-6.15||||0.04|TWO_SIDED|||||Parkinson Disease - Stage 1 UPDRS Part III (Baseline vs. 24 months)|paired t-test|||||||0.04
91548102|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.056||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part IV (Baseline vs. 24 months)||||0.94
91548103|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.414||||0.53|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part I (Baseline vs. 24 months)||||0.53
91548104|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-1.779||||0.38|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part II (Baseline vs. 24 months)||||0.38
91548105|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-3.59||||0.24|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part III (Baseline vs. 24 months)||||0.24
91548106|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.73|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part IV (Baseline vs. 24 months)||||0.73
91548107|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-1.187||||0.16|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part I (Baseline vs. 24 months)||||0.16
91548108|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.154||||0.75|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part II (Baseline vs. 24 months)||||0.75
91548109|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.28|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part III (Baseline vs. 24 months)||||0.28
91548110|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.077||||0.85|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part IV (Baseline vs. 24 months)||||0.85
91548111|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|0.204||||0.78|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part I (Baseline vs. 24 months)||||0.78
91548112|NCT03675282|182977385|SUPERIORITY||Mean Difference (Final Values)|-0.381||||0.03|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part IV (Baseline vs. 24 months)||||0.03
91548113|NCT03675282|182977386|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.3|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.30
91548114|NCT03675282|182977386|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.94
91548115|NCT03675282|182977386|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.45|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.45
91548116|NCT03675282|182977386|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.80
91548117|NCT04650087|182977395|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.44|1.95||||||||1.95|0.44|
91548118|NCT04650087|182977396|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.83|1.31||||||||1.31|0.83|
91548119|NCT04650087|182977397|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.78|1.24||||||||1.24|0.78|
91548120|NCT04650087|182977398|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.44|1.74||||||||1.74|0.44|
91548121|NCT04650087|182977399|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.12||||||||2.12|0.58|
91548122|NCT04650087|182977400|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.29|3.42||||||||3.42|0.29|
91548123|NCT04650087|182977401|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.03|3.18||||||||3.18|0.03|
91548124|NCT04650087|182977402|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.34|2.28||||||||2.28|0.34|
91548125|NCT03232138|182977412|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.22||||0.452|TWO_SIDED|95.0|0.03|0.41||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking.||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.41|0.03|0.452
91765842|NCT01623115|183420878|SUPERIORITY_OR_OTHER||LS mean difference|-49.5|||<|0.0001|TWO_SIDED|95.0|-54.2|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||-44.8|-54.2|<0.0001
91765843|NCT01623115|183420879|SUPERIORITY_OR_OTHER||LS mean difference|-45.8|||<|0.0001|TWO_SIDED|95.0|-49.8|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.8|<0.0001
91765844|NCT01623115|183420880|SUPERIORITY_OR_OTHER||LS mean difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-49.9|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.9|<0.0001
91765845|NCT01623115|183420881|SUPERIORITY_OR_OTHER||LS mean difference|-52.4|||<|0.0001|TWO_SIDED|95.0|-57.2|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-57.2|<0.0001
91765846|NCT01623115|183420882|SUPERIORITY_OR_OTHER||LS mean difference|-52.6|||<|0.0001|TWO_SIDED|95.0|-57.5|-47.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-57.5|<0.0001
91765847|NCT01623115|183420883|SUPERIORITY_OR_OTHER||LS mean difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-42.4|-35.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35|-42.4|<0.0001
91765848|NCT01623115|183420884|SUPERIORITY_OR_OTHER||LS mean difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-41.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-41.2|<0.0001
91548126|NCT03232138|182977412|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.12||||0.452|TWO_SIDED|95.0|-0.04|0.28||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.28|-0.04|0.452
91548127|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.738||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||All positive nuclei. Mean (95%CI) changes in baseline.||||0.738
91548128|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.78||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.780
91548129|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.733||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Moderate intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.733
91548130|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.751||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Strong-Intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.751
91548131|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.014||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of Ki-67 positive nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.014
91548132|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.056|||||||Covariance|Analysis of Covariance adjustment age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Week intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.056
91548133|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.028|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Moderate Intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.028
91548134|NCT03232138|182977413|EQUIVALENCE|2-sided P-value in the analysis||||||0.004|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.004
91548135|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.377||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) baseline.||||0.377
91548136|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis||||||0.413||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.413
91765849|NCT01623115|183420885|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.7|||<|0.0001|TWO_SIDED|95.0|-48.0|-39.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.4|-48|<0.0001
91765850|NCT01623115|183420886|SUPERIORITY_OR_OTHER||LS mean difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-35.7|<0.0001
91765851|NCT01623115|183420887|SUPERIORITY_OR_OTHER||LS mean difference|-56.2|||<|0.0001|TWO_SIDED|95.0|-62.4|-50.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50|-62.4|<0.0001
91765852|NCT01623115|183420888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.0|||<|0.0001|TWO_SIDED|95.0|48.9|498.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||498.1|48.9|<0.0001
91765853|NCT01623115|183420889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.6|||<|0.0001|TWO_SIDED|95.0|49.7|493.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||493.7|49.7|<0.0001
91765854|NCT01623115|183420890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|244.9|||<|0.0001|TWO_SIDED|95.0|34.4|1744.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1744.4|34.4|<0.0001
91765855|NCT01623115|183420891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.0|||<|0.0001|TWO_SIDED|95.0|33.9|1700.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1700.7|33.9|<0.0001
91765856|NCT01623115|183420892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-22.6|-12.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.9|-22.6|<0.0001
91765857|NCT01623115|183420893|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11|5|<0.0001
91765858|NCT01623115|183420894|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-21.3|-10.6||Threshold for significance was ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.6|-21.3|<0.0001
91765859|NCT01623115|183420895|SUPERIORITY_OR_OTHER||LS mean difference|4.7|||=|0.0002|TWO_SIDED|95.0|2.3|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|2.3|= 0.0002
91765860|NCT01623115|183420896|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-21.5|-13.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13|-21.5|<0.0001
91765861|NCT01623115|183420897|SUPERIORITY_OR_OTHER||LS mean difference|4.3||||0.0031|TWO_SIDED|95.0|1.5|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|1.5|0.0031
91765862|NCT01623115|183420898|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.7||||0.0003|TWO_SIDED|95.0|-15.0|-4.4||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.4|-15|0.0003
91765863|NCT01623115|183420899|SUPERIORITY_OR_OTHER||LS mean difference|2.8||||0.0187|TWO_SIDED|95.0|0.5|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|0.5|0.0187
91765864|NCT04950465|183420903|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2639|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA|||||0.43|-0.12|0.2639
91765865|NCT04950465|183420904|SUPERIORITY|||||||0.6978|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.6978
91548137|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline Moderate-intensity positive nuclei. TUNEL positive (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.338||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate Intensity positive nuclei. Mean (95%CI) at baseline.||||0.338
91548138|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) baseline.||||0.547
91548139|NCT03232138|182977414|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.291||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.291
91548140|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.552||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Weak-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.552
91548141|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.205||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.205
91548142|NCT03232138|182977414|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.295
91548143|NCT03232138|182977415|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) at baseline.||||0.295
91548144|NCT03232138|182977415|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.242||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||weak intensity positive nuclei. Mean (95%CI) at baseline.||||0.242
91765866|NCT04950465|183420904|SUPERIORITY|||||||0.813|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.8130
91765867|NCT04950465|183420905|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7645|TWO_SIDED|95.0|-0.26|0.19|||ANCOVA|||||0.19|-0.26|0.7645
91765868|NCT04950465|183420906|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.114||0.9728|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Week 4||0.22|-0.23|0.9728
91765869|NCT04950465|183420906|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14||0.2968|TWO_SIDED|95.0|-0.13|0.42|||ANCOVA|||Week 8||0.42|-0.13|0.2968
91765870|NCT04950465|183420907|SUPERIORITY|||||||0.1682|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.1682
91765871|NCT04950465|183420907|SUPERIORITY|||||||0.3937|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.3937
91765872|NCT00940901|183420908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Null hypothesis: there would be no difference in the number of participants who experienced at least a 50% reduction in the frequency of priapic episodes between baseline and 8 weeks post intervention, between the sildenafil and placebo groups||||1
91765873|NCT00940901|183420909|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||||||0.55
91548145|NCT03232138|182977415|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.985||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) at baseline.||||0.985
91548146|NCT03232138|182977415|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Strong intensity positive nuclei. Mean (95%CI) at baseline.||||0.547
91548147|NCT03232138|182977415|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.778||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.778
91548148|NCT03232138|182977415|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.685||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Weak intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.685
91548149|NCT03232138|182977415|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.469||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.469
91548150|NCT03232138|182977415|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarke||||||0.052||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.052
91548151|NCT03232138|182977416|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. the objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RNA integrity number or RIN.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|||||Hypothesis: Sulforaphane treatment downregulate these genes whose over-expressions are associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.82
91548152|NCT03232138|182977417|EQUIVALENCE|This analysis was focused on the gene set that were found to be down-regulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated down-regulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-expressions are associated with lung cancer risk.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.50
91548153|NCT03232138|182977418|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.15|STANDARD_ERROR_OF_MEAN|0.15||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate these genes whose over-expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
91765874|NCT00740207|183420917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.7142|TWO_SIDED|95.0|-1.3|0.9|||t-test, 2 sided|||Paired t-test to compare difference between the investigational product's mean change from predose to postdose||0.9|-1.3|0.7142
91765875|NCT00740207|183420918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.1698|TWO_SIDED|95.0|-79.2|-0.8|||Fisher Exact|||Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.||-0.8|-79.2|0.1698
91548154|NCT03232138|182977419|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated downregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-regulated expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.5
91548155|NCT03232138|182977420|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|||||Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.012
91548156|NCT03232138|182977421|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.12||0.0045|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in nasal epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis||Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.0045
91548157|NCT03232138|182977422|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
91548158|NCT03232138|182977423|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated downregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.27|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.27
91548159|NCT03232138|182977424|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.59||||||For severity by treatment group.|Fisher Exact|||||||0.590
91548160|NCT03232138|182977424|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.131||||||For attribution by treatment group.|Fisher Exact|||||||0.131
91548161|NCT04359108|182977433|OTHER|||||||0.02|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.02
91548162|NCT04359108|182977433|OTHER|||||||0.22|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.22
91548163|NCT04359108|182977433|OTHER|||||||0.017|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.017
91548164|NCT04359108|182977433|OTHER|||||||0.98|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.98
91548165|NCT04359108|182977433|OTHER|||||||0.014|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.014
91548166|NCT04359108|182977433|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
91548167|NCT04359108|182977433|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548168|NCT04359108|182977433|OTHER|||||||0.156|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.156
91548169|NCT04359108|182977433|OTHER|||||||0.541|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.541
91548170|NCT04359108|182977433|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548171|NCT04359108|182977433|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.10"|||
91548172|NCT04359108|182977433|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
91548173|NCT04359108|182977433|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.88"|||
91548174|NCT04359108|182977433|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.6"|||
91548175|NCT04359108|182977433|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A \*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
91548176|NCT04359108|182977433|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.10"|||
91548177|NCT04359108|182977433|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.45"|||
91548178|NCT04359108|182977433|OTHER|||||||||||||||||Navigate to Destination Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.02"|||
91548179|NCT04359108|182977434|OTHER|||||||0.3|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.30
91765876|NCT00740207|183420919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||1|TWO_SIDED|95.0|-28.6|8.6|||Fisher Exact|||Paired t-test to compare difference in percentage between the number of participants requiring repeat injections||8.6|-28.6|1.000
91548180|NCT04359108|182977434|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
91548181|NCT04359108|182977434|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548182|NCT04359108|182977434|OTHER|||||||0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.01
91548183|NCT04359108|182977434|OTHER|||||||0.93|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.93
91548184|NCT04359108|182977434|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548185|NCT04359108|182977434|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.27"|||
91548186|NCT04359108|182977434|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
91548187|NCT04359108|182977434|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.75"|||
91765877|NCT04797780|183420921|SUPERIORITY||Difference in CR Rate|5.06||||0.2084|TWO_SIDED|95.0|-7.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|-7.1|0.2084
91765878|NCT02940496|183420931|SUPERIORITY||Correlation Coefficient (2 sided test)|0.081||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
91548188|NCT04359108|182977434|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.60"|||
91548189|NCT04359108|182977434|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
91548190|NCT04359108|182977434|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.72"|||
91548191|NCT04359108|182977434|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.47"|||
91548192|NCT04359108|182977434|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 3.81"|||
91548193|NCT04359108|182977435|OTHER||||||<|0.001|||||||ANOVA|navigation system mode and test block as factors||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
91548194|NCT04359108|182977435|OTHER||||||<|0.01|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548195|NCT04359108|182977435|OTHER|||||||0.037||||||within-participant, 2 sided t-test|t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.037
91765879|NCT02940496|183420932|SUPERIORITY||Correlation Coefficient (2-sided test)|0.88||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
91765880|NCT02940496|183420933|SUPERIORITY||Correlation Coefficient (2-sided test)|0.79||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
91765881|NCT01895946|183421032|SUPERIORITY_OR_OTHER||Least square mean difference (LSM)|1.02|||||TWO_SIDED|90.0|0.86|1.2|||Mixed Models Analysis|||||1.20|0.86|
91765882|NCT01895946|183421032|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.67|||||TWO_SIDED|90.0|0.55|0.82|||Mixed Models Analysis|||||0.82|0.55|
91548196|NCT04359108|182977435|OTHER|||||||0.34|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.34
91548197|NCT04359108|182977435|OTHER|||||||0.1|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.10
91548198|NCT04359108|182977435|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
91548199|NCT04359108|182977435|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548200|NCT04359108|182977435|OTHER|||||||0.67|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.67
91548201|NCT04359108|182977435|OTHER|||||||0.23|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.23
91548202|NCT04359108|182977435|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548203|NCT04359108|182977435|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.79"|||
91548204|NCT04359108|182977435|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.38"|||
91548205|NCT04359108|182977435|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.24"|||
91548206|NCT04359108|182977435|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.85"|||
91548207|NCT04359108|182977435|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
91548208|NCT04359108|182977435|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.18"|||
91548209|NCT04359108|182977435|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.97"|||
91548210|NCT04359108|182977435|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.23"|||
91548211|NCT04359108|182977436|OTHER||||||<|0.001|||||||ANOVA|Single-factor test on navigation system mode||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
91548212|NCT04359108|182977436|OTHER|||||||0.17|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.17
91548213|NCT04359108|182977436|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||<0.01
91548214|NCT04359108|182977436|OTHER|||||||0.33|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.33
91548215|NCT04359108|182977436|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
91548216|NCT04359108|182977437|OTHER|||||||0.023|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high resolution vision modes||||0.023
91548217|NCT04359108|182977437|OTHER|||||||0.039|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high field-of-view vision modes||||0.039
91548218|NCT04359108|182977437|OTHER|||||||0.801|||||||ANOVA|2x2 within-participant test with factors of resolution and field-of-view||Significance of Interaction between Resolution and Field-of-View: test for null hypothesis of no interaction||||.801
91548219|NCT04176965|182977438|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in means between the 2 groups (FINEVISION HP - AcrySof SN60AT). Non-inferiority margin = 0.10 logMAR.|Mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.0084|<|0.0001|TWO_SIDED|90.0|0.0316|0.0592|||t-test, 1 sided|||||0.0592|0.0316|<0.0001
91548220|NCT04176965|182977439|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91548221|NCT04176965|182977440|NON_INFERIORITY|Noninferiority of FINEVISION HP compared to control in percentages of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in percentages between the 2 groups. If the upper limit of the confidence interval is less than 1.4%, the FINEVISION HP IOL will be considered statistically non-inferior to the control IOL.|Difference in percentages|0.3|||||TWO_SIDED|90.0|-0.76|1.36||||||||1.36|-0.76|
91765883|NCT01895946|183421033|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.9|||||TWO_SIDED|90.0|0.77|1.06|||Mixed Models Analysis|||||1.06|0.77|
91765884|NCT01895946|183421033|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.89|||||TWO_SIDED|90.0|0.76|1.05|||Mixed Models Analysis|||||1.05|0.76|
91548222|NCT04176965|182977445|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91548223|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548224|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548225|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548226|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548227|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548228|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548229|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548230|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548231|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548232|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548233|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548234|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91765885|NCT03543137|183421039|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.88|1.02|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.02|0.88|
91548235|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548236|NCT04176965|182977446|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548237|NCT04176965|182977446|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548238|NCT04176965|182977446|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548239|NCT04176965|182977446|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548240|NCT04176965|182977446|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548241|NCT04176965|182977446|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91765886|NCT03543137|183421040|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-inf fell completely within the range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.01|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.01|0.88|
91765887|NCT03543137|183421045|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the range.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.04|0.90|
91765888|NCT03678311|183421094|OTHER|The correlation between the outcome and AHI was tested by Spearman's correlation.|Spearman's correlation|0.13||||0.73|TWO_SIDED|95.0|-0.75|1.0|||Spearman's correlation|||Spearman's correlation was used to evaluate the relationship between the outcome and the apnea hypopnea index.||1.00|-0.75|0.73
91765889|NCT01389882|183421125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.007|STANDARD_DEVIATION|2.015||0.043|TWO_SIDED|95.0|0.036|1.978|||Paired t-test|||||1.978|0.036|0.043
91548242|NCT04176965|182977446|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548243|NCT04176965|182977446|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548244|NCT04176965|182977446|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
91548245|NCT03652688|182977455|SUPERIORITY||F|14.463|||<|0.001|TWO_SIDED||||||ANOVA|||The unit of analyses was the individual, nested within groups.||||<0.001
91548246|NCT03652688|182977456|SUPERIORITY|||||||0.08|||||||Chi-squared, Corrected|||||||.08
91548247|NCT03652688|182977457|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||||||0.954
91548248|NCT03652688|182977458|SUPERIORITY||Chi-Square|4.436||||0.035|TWO_SIDED||||||Chi-squared, Corrected|||||||.035
91548249|NCT03652688|182977459|SUPERIORITY||Chi-Square|2.615||||0.106|TWO_SIDED||||||Chi-squared, Corrected|||||||.106
91548250|NCT03652688|182977460|SUPERIORITY||Chi-Square|11.636|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
91548251|NCT05026320|182977467|EQUIVALENCE|The primary efficacy hypothesis to be tested was the equality of tenderness (algometry) over the initial 72 hours (algometry AUC 0-72).||||||0.0221|||||||ANCOVA|||||||0.0221
91548252|NCT03721952|182977513|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.13|STANDARD_ERROR_OF_MEAN|0.323||0.688|TWO_SIDED|95.0|-0.505|0.764|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average depression score \& negative sign of estimate defined as higher average depression score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.764|-0.505|0.688
91548253|NCT03721952|182977513|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.510
91765890|NCT01389882|183421126|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.232|STANDARD_DEVIATION|0.841||0.245|TWO_SIDED|95.0|-0.637|0.174|||Paired t-test|||||0.174|-0.637|0.245
91765891|NCT01389882|183421127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.095||0.257|TWO_SIDED|95.0|-0.02|0.714|||Paired t-test|||||0.714|-0.020|0.257
91548254|NCT03721952|182977514|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.143|STANDARD_ERROR_OF_MEAN|0.323||0.658|TWO_SIDED|95.0|-0.491|0.777|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average anxiety score \& negative sign of estimate defined as higher average anxiety score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.777|-0.491|0.658
91548255|NCT03721952|182977514|SUPERIORITY|||||||0.268|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.268
91548256|NCT03721952|182977515|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.2|STANDARD_ERROR_OF_MEAN|0.077||0.01|TWO_SIDED|95.0|-0.353|-0.048|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score over 3 follow-up points for intervention vs control groups.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||-0.048|-0.353|0.010
91548257|NCT03721952|182977515|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.175
91548258|NCT03721952|182977516|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.021|STANDARD_ERROR_OF_MEAN|0.092||0.817|TWO_SIDED|95.0|-0.203|0.16|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.160|-0.203|0.817
91548259|NCT03721952|182977516|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.949
91548260|NCT03721952|182977517|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.45|STANDARD_ERROR_OF_MEAN|0.239||0.06|TWO_SIDED|95.0|-0.919|0.02|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average preparation score \& negative sign of estimate defined as higher average preparation score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.020|-0.919|0.060
91765892|NCT01389882|183421128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_DEVIATION|1.541||0.601|TWO_SIDED|95.0|-0.554|0.931|||Paired t-test|||||0.931|-0.554|0.601
91765893|NCT01389882|183421129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_DEVIATION|0.355||0.085|TWO_SIDED|95.0|-0.32|0.023|||Paired t-test|||||0.023|-0.320|0.085
91765894|NCT01389882|183421130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.516|STANDARD_DEVIATION|9.786||0.002|TWO_SIDED|95.0|1.799|11.232|||Wilcoxon signed-rank test|||||11.232|1.799|0.002
91765895|NCT01389882|183421131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|2.516||0.009|TWO_SIDED|95.0|0.478|2.904|||Paired t-test, 2-sided|||||2.904|0.478|0.009
91765896|NCT01389882|183421132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.692|STANDARD_DEVIATION|2.192||0.314|TWO_SIDED|95.0|-0.364|1.749|||Wilcoxon signed-rank test|||||1.749|-0.364|0.314
91548261|NCT03721952|182977517|SUPERIORITY|||||||0.701|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.701
91548262|NCT03721952|182977518|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.393||||0.053|TWO_SIDED|95.0|-0.791|0.005|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average goal-concordant care \& negative sign of estimate defined as higher average goal-concordant care, over 3 follow-up points for intervention group vs. control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.005|-0.791|0.053
91548263|NCT03721952|182977518|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.039
91548264|NCT03721952|182977519|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.636||||0.239|TWO_SIDED|95.0|-0.425|1.7|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.||Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||1.700|-0.425|0.239
91548265|NCT03721952|182977519|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.170
91765897|NCT01389882|183421133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_DEVIATION|0.047||0.515|TWO_SIDED|95.0|-0.03|0.016|||Paired t-test|||||0.016|-0.030|0.515
91765898|NCT01389882|183421134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1105|STANDARD_DEVIATION|7.501||0.949|TWO_SIDED|95.0|-3.505|3.726|||Paired t-test|||||3.726|-3.505|0.949
91765899|NCT01389882|183421135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_DEVIATION|12.081||0.709|TWO_SIDED|95.0|-4.77|6.875|||Paired t-test|||||6.875|-4.770|0.709
91765900|NCT01389882|183421136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.274|STANDARD_DEVIATION|2.233||0.6|TWO_SIDED|95.0|-1.35|0.802|||Paired t-test|||||0.802|-1.350|0.600
91765901|NCT01045967|183421141|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|90.7|122.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||122|90.7|
91548266|NCT03721952|182977520|SUPERIORITY||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.041||0.029|TWO_SIDED|95.0|0.009|0.169|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher proportion of readmissions \& negative sign of estimate defined as lower proportion of readmissions, for the intervention group vs. the control group|Superior outcome for Group2 (Patient-Intervention)||0.169|0.009|0.029
91548267|NCT03721952|182977521|SUPERIORITY||Slope|1.078|STANDARD_ERROR_OF_MEAN|0.808||0.183|TWO_SIDED|95.0|-0.511|2.666|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||2.666|-0.511|0.183
91548268|NCT03721952|182977522|SUPERIORITY||Slope|1.687|STANDARD_ERROR_OF_MEAN|3.157||0.593|TWO_SIDED|95.0|-4.518|7.892|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||7.892|-4.518|0.593
91548269|NCT03721952|182977523|SUPERIORITY||Slope|4.365|STANDARD_ERROR_OF_MEAN|6.987||0.533|TWO_SIDED|95.0|-9.367|18.097|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||18.097|-9.367|0.533
91548270|NCT03721952|182977524|SUPERIORITY||Slope|1.07|STANDARD_ERROR_OF_MEAN|1.07||0.318|TWO_SIDED|95.0|-1.032|3.173|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||3.173|-1.032|0.318
91765902|NCT01045967|183421142|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.2|||||TWO_SIDED|90.0|86.1|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.1|
91765903|NCT01045967|183421143|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|86.3|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.3|
91765904|NCT01072188|183421174|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91765905|NCT01072188|183421175|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91765906|NCT00896298|183421177|SUPERIORITY|||||||0.2572|||||||Mixed Models Analysis|||||||0.2572
91765907|NCT00896298|183421178|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||||||0.71
91765908|NCT00896298|183421179|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
91548271|NCT03721952|182977525|SUPERIORITY||Slope|4.117|STANDARD_ERROR_OF_MEAN|3.506||0.241|TWO_SIDED|95.0|-2.773|11.007|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||11.007|-2.773|0.241
91765909|NCT00896298|183421180|SUPERIORITY|||||||0.0256|||||||Mixed Models Analysis|||||||0.0256
91765910|NCT00790192|183421184|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91765911|NCT00790192|183421185|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
91765912|NCT01588561|183421207|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum|||
91548272|NCT03721952|182977526|SUPERIORITY||Slope|8.195|STANDARD_ERROR_OF_MEAN|7.466||0.273|TWO_SIDED|95.0|-6.479|22.868|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||22.868|-6.479|0.273
91548273|NCT03721952|182977527|SUPERIORITY||Slope|-0.0000009|STANDARD_ERROR_OF_MEAN|0.00000248||0.71|TWO_SIDED|95.0|-0.0000057|0.0000039|||other type of regression|Regression \[gamma family, link function g(u)=u-0.9\], outcome on random group (0=control, 1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000039|-0.0000057|0.710
91548274|NCT03721952|182977528|SUPERIORITY||Slope|0.00000113|STANDARD_ERROR_OF_MEAN|0.00000215||0.599|TWO_SIDED|95.0|-0.000003|0.0000053|||other type of regression|Regression \[inverse Gaussian family, link function g(u)=u-0.9\], outcome on random group (0=control,1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000053|-0.0000030|0.599
91548275|NCT03476460|182977543|NON_INFERIORITY|"We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable.~The non-inferiority of oral hydration would be shown if the upper limit of the 95% CI of the absolute risk difference between the groups was less than 5% (non-inferiority margin, indicated by the black dashed line)"|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|7.0|||||The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.|Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).||7.0|-4.8|
91548276|NCT03476460|182977544|SUPERIORITY|||||||0.299||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 24h from baseline||||0.299
91548277|NCT03476460|182977545|SUPERIORITY|||||||0.477||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 48h from baseline||||0.477
91548278|NCT03476460|182977546|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.042||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.042
91548279|NCT03476460|182977547|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.121||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.121
91548280|NCT03476460|182977548|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.418||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.418
91765913|NCT01588561|183421208|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum|||
91765914|NCT01588561|183421209|OTHER||||||||||||||||||Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal\&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum|||
91765915|NCT01450761|183421211|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.3775|TWO_SIDED|95.0|0.807|1.085|||Log Rank||HR = ipilimumab over placebo|||1.085|0.807|0.3775
91548281|NCT03476460|182977549|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.901||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.901
91548282|NCT03476460|182977550|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.72||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.720
91548283|NCT03476460|182977551|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.688||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.688
91548284|NCT03476460|182977552|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.535||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.535
91548285|NCT03476460|182977553|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.338||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.338
91548286|NCT03476460|182977554|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.764||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.764
91548287|NCT03476460|182977555|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.458||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.458
91548288|NCT03476460|182977556|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.893||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.893
91548289|NCT03476460|182977557|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.645||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.645
91548290|NCT05480124|182977583|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
91548291|NCT05480124|182977585|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
91548292|NCT05480124|182977586|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
91548293|NCT05480124|182977587|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
91548294|NCT05480124|182977588|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||||||0.201
91548295|NCT03640312|182977602|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18||Adjusting for baseline systolic blood pressure.|Mixed Models Analysis|Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.||||1.18|-10.74|0.114
91548296|NCT03640312|182977603|SUPERIORITY|Adjusted for baseline systolic blood pressure.|Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18|||Mixed Models Analysis|||||1.18|-10.74|0.114
91548297|NCT03640312|182977604|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11||Adjusted Least Squares Mean.|Mixed Models Analysis|||Adjusted for baseline diastolic blood pressure.||-1.11|-8.62|0.012
91548298|NCT03640312|182977605|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11|||Mixed Models Analysis|||||-1.11|-8.62|0.012
91548299|NCT03640312|182977606|SUPERIORITY||Odds Ratio (OR)|2.4||||0.077|TWO_SIDED|95.0|0.91|6.35|||Mixed Models Analysis|Generalized Linear Mixed Model (binomial distribution assumption with logit link).||||6.35|0.91|0.077
91548300|NCT03640312|182977607|SUPERIORITY||Odds Ratio (OR)|0.13||||0.003|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||0.48|0.03|0.003
91765916|NCT01450761|183421212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.961||||0.5678|TWO_SIDED|95.0|0.838|1.102|||Log Rank||HR = ipilimumab over placebo|||1.102|0.838|0.5678
91765917|NCT01450761|183421213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0161|TWO_SIDED|95.0|0.747|0.971|||Log Rank||HR = ipilimumab over placebo|||0.971|0.747|0.0161
91765918|NCT01818596|183421217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|98.94|||||TWO_SIDED|90.0|93.71|104.46|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI). Postbaseline value and baseline value were used as test and reference, respectively.||104.46|93.71|
91548301|NCT03640312|182977608|SUPERIORITY||Odds Ratio (OR)|0.8||||0.71|TWO_SIDED|95.0|0.24|2.69|||Mixed Models Analysis|||Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.||2.69|0.24|0.710
91765919|NCT01818596|183421217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|102.66|||||TWO_SIDED|90.0|97.11|108.53|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI. Week 24 value and baseline value were used as test and reference, respectively.||108.53|97.11|
91548302|NCT03640312|182977609|SUPERIORITY||Odds Ratio (OR)|0.64||||0.437|TWO_SIDED|95.0|0.21|1.98|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||1.98|0.21|0.437
91548303|NCT03640312|182977610|SUPERIORITY||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|2.01||0.09|TWO_SIDED|95.0|-7.49|0.59||Adjusted for baseline T score|ANCOVA|||Statistical test for difference in Physical Health T Score||0.59|-7.49|0.09
91548304|NCT03640312|182977610|SUPERIORITY||Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.22|4.32||Adjusted for baseline mental health T score|ANCOVA|||Statistical test for difference in Mental Health T Score||4.32|-3.22|0.77
91548305|NCT03640312|182977611|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.182|||Mixed Models Analysis|||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.||1.182|-10.74|0.114
91548306|NCT03640312|182977612|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.49|TWO_SIDED|95.0|-0.15|0.02|||Fisher Exact|||||0.02|-0.15|0.49
91548307|NCT03640312|182977613|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.21|TWO_SIDED|95.0|-0.33|0.03|||Chi-squared|||||0.03|-0.33|0.21
91548308|NCT03640312|182977614|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.18|TWO_SIDED|95.0|-0.41|0.08|||Chi-squared|||||0.08|-0.41|0.18
91548309|NCT03640312|182977615|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.56|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||||0.13|-0.24|0.56
91548310|NCT03640312|182977616|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.45||0.12|TWO_SIDED|95.0|-1.61|0.19||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.19|-1.61|0.12
91548311|NCT03640312|182977617|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.95||0.94|TWO_SIDED|95.0|-1.84|1.99||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis||The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed.|||1.99|-1.84|0.94
91548312|NCT03640312|182977618|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.55|TWO_SIDED|95.0|-0.07|0.04||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.04|-0.07|0.55
91548313|NCT03536754|182977619|SUPERIORITY||LSM Ratio|1.23|STANDARD_ERROR_OF_MEAN|1.171||0.1924|TWO_SIDED|90.0|0.95|1.6||≤ 0.1924|Mixed effects model for repeated measure|||||1.6|0.95|0.1924
91548314|NCT03536754|182977619|SUPERIORITY||LSM Ratio|1.35|STANDARD_ERROR_OF_MEAN|1.172||0.0612|TWO_SIDED|90.0|1.04|1.76||≤ 0.0612|Mixed effects model for repeated measure|||||1.76|1.04|0.0612
91548315|NCT03536754|182977619|SUPERIORITY||LSM Ratio|1.05|STANDARD_ERROR_OF_MEAN|1.169||0.7653|TWO_SIDED|90.0|0.81|1.36||≤ 0.7653|Mixed effects model for repeated measure|||||1.36|0.81|0.7653
91548316|NCT03536754|182977619|SUPERIORITY||LSM Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.136||0.1537|TWO_SIDED|90.0|0.97|1.48||≤ 0.1537|Mixed effects model for repeated measure|||||1.48|0.97|0.1537
91548317|NCT05492318|182977716|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|105.67|||||TWO_SIDED|90.0|91.72|121.74||||||"Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV.~Cmax"||121.74|91.72|
91548318|NCT05492318|182977716|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|91.56|||||TWO_SIDED|90.0|86.16|97.31||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||97.31|86.16|
91548319|NCT05492318|182977716|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|92.13|||||TWO_SIDED|90.0|75.97|111.73||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||111.73|75.97|
91548320|NCT05492318|182977716|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|93.59|||||TWO_SIDED|90.0|83.72|104.63||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||104.63|83.72|
91548321|NCT05492318|182977716|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|124.02|||||TWO_SIDED|90.0|114.38|134.47||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||134.47|114.38|
91548322|NCT05492318|182977716|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|117.47|||||TWO_SIDED|90.0|104.78|131.69||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Max||131.69|104.78|
91765920|NCT03801174|183421235|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.92||0.804|TWO_SIDED|95.0|-2.0|1.6|||Mixed Models Analysis|||||1.6|-2.0|.804
91548323|NCT05492318|182977716|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|139.28|||||TWO_SIDED|90.0|128.71|150.67||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||150.67|128.71|
91548324|NCT05492318|182977716|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|141.61|||||TWO_SIDED|90.0|122.36|163.88||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||163.88|122.36|
91548325|NCT05492318|182977717|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.68|||||TWO_SIDED|90.0|60.77|89.33||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||89.33|60.77|
91548326|NCT05492318|182977717|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.38|||||TWO_SIDED|90.0|57.94|85.5||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||85.50|57.94|
91548327|NCT05492318|182977717|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|65.31|||||TWO_SIDED|90.0|53.33|79.98||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||79.98|53.33|
91548328|NCT05492318|182977717|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|62.18|||||TWO_SIDED|90.0|50.86|75.95||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. Cmax||75.95|50.86|
91548329|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric LS means|107.35|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.49|103.35|
91548330|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|106.18|||||TWO_SIDED|90.0|100.84|111.8||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.80|100.84|
91548331|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|121.77|||||TWO_SIDED|90.0|117.56|126.12||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||126.12|117.56|
91765921|NCT03801174|183421236|SUPERIORITY||Mean Difference (Net)|50.2|STANDARD_ERROR_OF_MEAN|93.0||0.59|TWO_SIDED|95.0|-132.0|233.0|||Mixed Models Analysis|||||233|-132|.590
91765922|NCT03801174|183421237|SUPERIORITY||Mean Difference (Net)|806.0|STANDARD_ERROR_OF_MEAN|443.0||0.069|TWO_SIDED|95.0|-64.0|1675.0|||Mixed Models Analysis|||||1675|-64|.069
91765923|NCT04170543|183421280|OTHER||LS Mean Difference in Percent Change|-2.85||||0.8338|TWO_SIDED|90.0|-22.61|21.94||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||21.94|-22.61|0.8338
91548332|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|122.97|||||TWO_SIDED|90.0|115.08|131.41||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||131.41|115.08|
91548333|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|137.42|||||TWO_SIDED|90.0|128.09|147.43||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||147.43|128.09|
91548334|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|131.21|||||TWO_SIDED|90.0|122.47|140.59||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||140.59|122.47|
91548335|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|157.77|||||TWO_SIDED|90.0|147.49|168.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam. - AUC0-t||168.76|147.49|
91548336|NCT05492318|182977722|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|158.3|||||TWO_SIDED|90.0|145.23|172.54||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: - AUC0-t||172.54|145.23|
91548337|NCT05492318|182977723|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.9|||||TWO_SIDED|90.0|58.43|83.64||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics - AUC0-t||83.64|58.43|
91548338|NCT05492318|182977723|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.43|||||TWO_SIDED|90.0|58.67|86.98||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||86.98|58.67|
91548339|NCT05492318|182977723|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.94|||||TWO_SIDED|90.0|58.82|83.15||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||83.15|58.82|
91548340|NCT05492318|182977723|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|72.3|||||TWO_SIDED|90.0|59.92|87.25||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||87.25|59.92|
91765924|NCT04170543|183421280|OTHER||LS Mean Difference in Percent Change|-19.52||||0.1169|TWO_SIDED|90.0|-35.92|1.07||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||1.07|-35.92|0.1169
91548341|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|107.55|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV: AUC0-inf||111.49|103.35|
91548342|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|112.17|||||TWO_SIDED|90.0|106.21|118.46||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||118.46|106.21|
91548343|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|124.01|||||TWO_SIDED|90.0|119.44|128.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||128.76|119.44|
91548344|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|134.29|||||TWO_SIDED|90.0|126.15|142.96||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV. AUC0-inf||142.96|126.15|
91548345|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|138.75|||||TWO_SIDED|90.0|129.05|149.18||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||149.18|129.05|
91548346|NCT05492318|182977724|OTHER||GMR corresponds to the ratio of the Geom|134.18|||||TWO_SIDED|90.0|124.19|144.97||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||144.97|124.19|
91548347|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|162.76|||||TWO_SIDED|90.0|151.13|175.28||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||175.28|151.13|
91548348|NCT05492318|182977724|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|161.2|||||TWO_SIDED|90.0|147.8|175.82||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||175.82|147.80|
91765925|NCT04170543|183421280|OTHER||LS Mean Difference in Percent Change|-17.47||||0.1774|TWO_SIDED|90.0|-34.71|4.32||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||4.32|-34.71|0.1774
91765926|NCT04170543|183421280|OTHER||LS Mean Difference in Percent Change|-7.22||||0.5379|TWO_SIDED|90.0|-24.05|13.35||Unadjusted two-sided p-value|MMRM|||||13.35|-24.05|0.5379
91765927|NCT04170543|183421281|OTHER||LS Mean Difference in Percent Change|-13.02||||0.1929|TWO_SIDED|90.0|-27.08|3.75||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||3.75|-27.08|0.1929
91548349|NCT05492318|182977725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.96|||||TWO_SIDED|90.0|58.83|83.2||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.20|58.83|
91548350|NCT05492318|182977725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.65|||||TWO_SIDED|90.0|59.08|86.88||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||86.88|59.08|
91548351|NCT05492318|182977725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.37|||||TWO_SIDED|90.0|59.64|83.03||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.03|59.64|
91548352|NCT05492318|182977725|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.45|||||TWO_SIDED|90.0|60.79|88.75||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. AUC0-inf||88.75|60.79|
91548353|NCT03964350|182977735|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
91548354|NCT02379156|182977736|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in core body temperature (Tcore) from baseline (BL) values to after cold exposure (Cold) were analyzed using a Mixed Model ANOVA. We hypothesized that participants with tetraplegia would have a greater decrease in Tcore when exposed to cool ambient temperature than control participants exposed to the same cool ambient temperature.||||<0.001
91548355|NCT02379156|182977736|SUPERIORITY|||||||0.006|||||||ANOVA|||Within-group differences in the change in (Tcore) in the participants with tetraplegia from BL values to Cold, with and without a dose of 10 mg of midodrine (two separate visits), were analyzed using a Repeated Measures ANOVA .||||0.006
91548356|NCT02379156|182977737|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Between-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using an independent samples T-test. We hypothesized that participants with tetraplegia would have a greater percent change in total WAIS IV scores due to impaired cognitive function post cool ambient exposure.||||.042
91548357|NCT02379156|182977737|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||"Within-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in total WAIS IV scores than the same participants in the With drug condition."||||0.149
91548358|NCT02379156|182977738|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a mixed-model ANOVA for the AB vs Tetra comparison. We hypothesized that participants with tetraplegia would have a smaller change in Tsk due to being in a constant state of vasodilation.||||<0.001
91765928|NCT04170543|183421281|OTHER||LS Mean Difference in Percent Change|-25.71||||0.0062|TWO_SIDED|90.0|-37.83|-11.22||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-11.22|-37.83|0.0062
91765929|NCT04170543|183421281|OTHER||LS Mean Difference in Percent Change|-18.2||||0.0705|TWO_SIDED|90.0|-31.86|-1.81||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-1.81|-31.86|0.0705
91548359|NCT02379156|182977738|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a repeated measures ANOVA for the within-group comparison of drug vs no drug in the tetraplegia group. We hypothesized that participants with tetraplegia with drug would have a larger decrease in Tsk due to enhanced peripheral vasoconstriction due to the drug's effects.||||<.001
91548360|NCT02379156|182977739|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Between-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using independent samples T-test. We hypothesized that participants with tetraplegia would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation.||||<0.001
91548361|NCT02379156|182977739|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||"Within-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation."||||0.066
91548362|NCT02379156|182977740|SUPERIORITY|||||||0.127|||||||t-test, 2 sided|||Between-group differences in the percent change in VO2 from baseline to after cool ambient exposure were analyzed using independent samples t-test. We hypothesized that participants with tetraplegia would have a smaller percent change in VO2 consumption.||||0.127
91548363|NCT02379156|182977740|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||"Within-group differences in the percent change in VO2 consumption from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in VO2 consumption due to impaired vasoconstriction and greater heat loss compared to the With Drug condition, in response to cool ambient exposure."||||0.964
91548364|NCT02754882|182977762|EQUIVALENCE|Pre-defined equivalence margin was \[0.737, 1.357\]|Risk Ratio (RR)|1.11|||||TWO_SIDED|90.0|0.975|1.269|||||SB8 vs. Avastin|||1.269|0.975|
91548365|NCT01212029|182977772|OTHER|One sample t-tests of standardized regression coefficients of RMSSD predicting O2Hb during baseline||||||0.008||||||t-test was performed 16 times for 16 fNIRS channels. The reported p-value is an uncorrected value for channel 10.|t-test, 2 sided|||Null hypothesis: there is no significant correlation between RMSSD and O2Hb levels during baseline||||0.008
91548366|NCT01212029|182977773|OTHER|||||||0.0105|||||||Tukey method|||||||0.0105
91765930|NCT04170543|183421281|OTHER||LS Mean Difference in Percent Change|-15.56||||0.0764|TWO_SIDED|90.0|-27.82|-1.21||Unadjusted two-sided p-value|MMRM|||||-1.21|-27.82|0.0764
91765931|NCT04170543|183421282|OTHER||LS Mean Difference in Percent Change|7.25||||0.5474|TWO_SIDED|90.0|-11.45|29.88||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||29.88|-11.45|0.5474
91548367|NCT02671903|182977776|SUPERIORITY||Fixed Effect for Treatment|0.25||||0.3|TWO_SIDED|95.0|-0.23|0.73|||Mixed Models Analysis|||Change in treatment effect taken from mixed-model output||0.73|-0.23|0.3
91548368|NCT03138512|182977829|SUPERIORITY||Cox Proportional Hazard|0.95||||0.6676||95.0|0.75|1.2|||Log Rank|||||1.20|0.75|0.6676
91548369|NCT03138512|182977829|SUPERIORITY||Cox Proportional Hazard|0.93||||0.6556||95.0|0.67|1.28|||Log Rank|||||1.28|0.67|0.6556
91548370|NCT03138512|182977830|SUPERIORITY||Cox Proportional Hazard|1.26||||0.2436||95.0|0.85|1.85|||Log Rank|||Treatment Part A||1.85|0.85|0.2436
91548371|NCT03138512|182977830|SUPERIORITY||Cox Proportional Hazard|1.36||||0.45||95.0|0.61|3.07|||Log Rank|||Treatment Part B||3.07|0.61|0.4500
91548372|NCT03138512|182977832|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.89|1.67||||||||1.67|0.89|
91548373|NCT03138512|182977833|SUPERIORITY||Cox Proportional Hazard|0.75||||||95.0|0.33|1.68||||||||1.68|0.33|
91548374|NCT05481216|182977895|OTHER|Unadjusted and adjusted hazard ratios (HR) will be calculated using a proportional Cox regression model. The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||||2.29|0.73|
91548375|NCT05481216|182977895|OTHER||Adjusted Hazard Ratio|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.||2.29|0.73|
91765932|NCT04170543|183421282|OTHER||LS Mean Difference in Percent Change|3.11||||0.792|TWO_SIDED|90.0|-14.83|24.82||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||24.82|-14.83|0.7920
91765933|NCT04170543|183421282|OTHER||LS Mean Difference in Percent Change|-3.4||||0.7711|TWO_SIDED|90.0|-20.59|17.51||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||17.51|-20.59|0.7711
91548376|NCT05481216|182977899|OTHER|||||||0.009|||||||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.||||0.009
91548377|NCT05481216|182977920|OTHER||Odds Ratio (OR)|0.85||||0.033|TWO_SIDED|95.0|0.74|0.99|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||0.99|0.74|0.033
91548378|NCT05481216|182977921|OTHER||Odds Ratio (OR)|1.93||||0.012|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||3.22|1.16|0.012
91548379|NCT05481216|182977922|OTHER||Odds Ratio (OR)|0.99||||0.458|TWO_SIDED|95.0|0.95|1.02|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||1.02|0.95|0.458
91548380|NCT05481216|182977923|OTHER||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.61|4.57|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||4.57|1.61|<0.001
91548381|NCT05481216|182977924|OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.34|2.25|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||2.25|1.34|<0.001
91548382|NCT04005716|182977925|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.93|||Log Rank|Stratified log rank test with ECOG performance status, and investigator chosen platinum as stratification factors.|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|The null hypothesis stated that the overall survival in Arm A (Tislelizumab + Chemotherapy) is less than or equal to that in Arm B (the placebo group), while the alternative hypothesis posits that the overall survival in Arm A is greater than that in Arm B.||0.93|0.61|0.0040
91548383|NCT04005716|182977926|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.78|||Log Rank|One-sided log-rank test p-value, stratified by ECOG performance status (1 vs 0) and type of platinum therapy (carboplatin vs cisplatin).|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|||0.78|0.52|<0.0001
91548384|NCT04005716|182977927|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.9|1.96|||||Odds ratio was calculated using Cochran-Mantel-Haenszel estimates and stratified by ECOG performance (1 vs 0) and platinum (Carboplatin vs Cisplatin)|||1.96|0.90|
91548385|NCT04005716|182977934|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.642|1.33|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-C30 Physical Functioning Score||1.330|0.642|
91548386|NCT04005716|182977934|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.473|1.123|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Coughing Score||1.123|0.473|
91765934|NCT04170543|183421282|OTHER||LS Mean Difference in Percent Change|5.27||||0.6163|TWO_SIDED|90.0|-11.08|24.62||Unadjusted two-sided p-value|MMRM|||||24.62|-11.08|0.6163
91765935|NCT04170543|183421284|OTHER||LS Mean Difference in Percent Change|2.43||||0.8537|TWO_SIDED|90.0|-17.35|26.95||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||26.95|-17.35|0.8537
91765936|NCT04170543|183421284|OTHER||LS Mean Difference in Percent Change|-15.63||||0.1989|TWO_SIDED|90.0|-32.14|4.89||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||4.89|-32.14|0.1989
91548387|NCT04005716|182977934|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.485|1.057|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Chest Pain Score||1.057|0.485|
91548388|NCT02120456|182978019|SUPERIORITY||Rate ratio|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.58|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.58|0.34|<0.001
91548389|NCT02120456|182978019|SUPERIORITY||Rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.44|0.73|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.73|0.44|<0.001
91548390|NCT02120456|182978019|SUPERIORITY||Rate ratio|1.26||||0.058|TWO_SIDED|95.0|0.99|1.6|||Negative binominal regression|||||1.60|0.99|0.058
91548391|NCT02120456|182978020|SUPERIORITY||Ratio of clearance rates|1.05||||0.94|TWO_SIDED|95.0|0.3|4.73|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.73|0.30|0.94
91548392|NCT02120456|182978020|SUPERIORITY||Ratio of clearance rates|1.0||||1|TWO_SIDED|95.0|0.28|4.51|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.51|0.28|1.00
91548393|NCT02120456|182978020|SUPERIORITY||Ratio of clearance rates|0.95||||0.93|TWO_SIDED|95.0|0.31|2.89|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||2.89|0.31|0.93
91548394|NCT02120456|182978021|SUPERIORITY||Ratio of clearance rates|2.88||||0.003|TWO_SIDED|95.0|1.36|7.85|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.85|1.36|0.003
91548395|NCT02120456|182978021|SUPERIORITY||Ratio of clearance rates|2.84||||0.004|TWO_SIDED|95.0|1.35|7.74|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.74|1.35|0.004
91548396|NCT02120456|182978021|SUPERIORITY||Ratio of clearance rates|0.99||||0.95|TWO_SIDED|95.0|0.66|1.47|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||1.47|0.66|0.95
91765937|NCT04170543|183421284|OTHER||LS Mean Difference in Percent Change|-17.96||||0.1346|TWO_SIDED|90.0|-34.01|1.99||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||1.99|-34.01|0.1346
91548397|NCT03378570|182978039|OTHER|comparative effectiveness trial||||||0.945|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.945
91548398|NCT03378570|182978040|OTHER|comparative effectiveness trial||||||0.828|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.828
91548399|NCT03378570|182978041|OTHER|comparative effectiveness trial||||||0.252|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.252
91548400|NCT03378570|182978042|OTHER|||||||0.505||||||p value for response rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.505
91548401|NCT03378570|182978042|OTHER|||||||0.888||||||p value for remission rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.888
91548402|NCT03378570|182978043|OTHER|||||||0.994|||||||Chi-squared|p value for response rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.994
91548403|NCT03378570|182978043|OTHER|||||||0.911|||||||Chi-squared|p value for remission rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.911
91548404|NCT03378570|182978044|OTHER|||||||0.778|||||||t-test, 2 sided|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.778
91548405|NCT03378570|182978045|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||.951
91548406|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.278|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Positive Affect.||||.278
91548407|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.024|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, General Life Satisfaction.||||.024
91548408|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.439|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Meaning \& Purpose.||||.439
91548409|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.025|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Emotional Support.||||.025
91765938|NCT04170543|183421284|OTHER||LS Mean Difference in Percent Change|-6.38||||0.5683|TWO_SIDED|90.0|-22.59|13.23||Unadjusted two-sided p-value|MMRM|||||13.23|-22.59|0.5683
91548410|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.007|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Instrumental Support.||||.007
91548411|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Friendship.||||.014
91548412|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.398|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Loneliness.||||.398
91548413|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.064|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Rejection.||||.064
91548414|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.368|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Hostility.||||.368
91548415|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.504|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Self-Efficacy.||||.504
91548416|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.371|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Stress.||||.371
91548417|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.438|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Affect.||||.438
91765939|NCT04170543|183421285|OTHER||LS Mean Difference in Percent Change|-7.93||||0.4226|TWO_SIDED|90.0|-22.3|9.1||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||9.10|-22.30|0.4226
91765940|NCT04170543|183421285|OTHER||LS Mean Difference in Percent Change|-20.61||||0.0287|TWO_SIDED|90.0|-33.25|-5.58||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-5.58|-33.25|0.0287
91765941|NCT04170543|183421285|OTHER||LS Mean Difference in Percent Change|-18.73||||0.0498|TWO_SIDED|90.0|-31.7|-3.3||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-3.30|-31.70|0.0498
91765942|NCT04170543|183421285|OTHER||LS Mean Difference in Percent Change|-13.27||||0.1236|TWO_SIDED|90.0|-25.51|0.98||Unadjusted two-sided p-value|MMRM|||||0.98|-25.51|0.1236
91765943|NCT04378270|183421309|OTHER||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|1.61||0.0796|TWO_SIDED|95.0|-0.3687|6.2287|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||6.2287|-0.3687|0.0796
91548418|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.096|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Somatic Arousal.||||.096
91548419|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.132|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Sadness.||||.132
91548420|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Affect.||||.951
91548421|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.852|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Hostility.||||.852
91548422|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.083|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Physical Aggression.||||.083
91548423|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.391|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Negative Affect.||||.391
91548424|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Social Satisfaction.||||.014
91548425|NCT03378570|182978046|OTHER|comparative effectiveness trial||||||0.109|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Psychological Well Being.||||.109
91548426|NCT03378570|182978047|SUPERIORITY|||||||0.231||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.875 Week 1 p = 0.084 Week 2 p = 0.277 Week 3 p = 0.686 Week 4 p = 0.369 Week 5 p = 0.806"||||||0.231
91548427|NCT03378570|182978048|SUPERIORITY|||||||0.963||||||Week 6-7 Follow-up p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~Evaluation p = 0.570 Week 2-3 Follow-up p = 0.063 Week 4-5 Follow-up p = 0.792"||||||0.963
91548428|NCT03378570|182978049|SUPERIORITY|||||||0.051||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.772 Week 1 p = 0.194 Week 2 p = 0.127 Week 3 p = 0.196 Week 4 p = 0.079 Week 5 p = 0.187"||||||0.051
91548429|NCT01787383|182978050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.13
91548430|NCT01787383|182978051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|TWO_SIDED||||||Regression, Logistic|||||||0.34
91548431|NCT01787383|182978052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED||||||Regression, Logistic|||||||0.088
91548432|NCT01787383|182978053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
91548433|NCT01787383|182978054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
91548434|NCT01787383|182978055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.033
91548435|NCT01787383|182978056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
91548436|NCT01787383|182978057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.66
91548437|NCT03443323|182978058|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
91548438|NCT03443323|182978059|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
91548439|NCT03443323|182978060|SUPERIORITY|||||||0.007||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||0.007
91548440|NCT03443323|182978061|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||<.001
91765944|NCT04378270|183421310|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.879||0.0634|TWO_SIDED|95.0|-3.5014|0.1014|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||0.1014|-3.5014|0.0634
91548441|NCT03443323|182978062|SUPERIORITY||||||<|0.06||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||<.06
91548442|NCT03443323|182978063|SUPERIORITY||||||>|0.0083||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||>.0083
91548443|NCT03443323|182978064|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
91548444|NCT03443323|182978065|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
91548445|NCT03770273|182978084|OTHER|||||||0.774|||||||Regression, Linear|||||||0.7740
91548446|NCT03770273|182978086|OTHER|||||||0.1071|||||||Regression, Linear|||||||0.1071
91548447|NCT03770273|182978087|OTHER|||||||0.4904|||||||Regression, Linear|||||||0.4904
91548448|NCT03770273|182978088|OTHER|||||||0.1399|||||||Regression, Linear|||||||0.1399
91548449|NCT01999075|182978099|SUPERIORITY||Mean Difference (Net)|1.9||||0.68|TWO_SIDED|95.0|-6.9|10.7||The a priori threshold for statistical significance was a two-sided p-value of 0.05.|ANCOVA||"The mean difference between the intervention and the control group in the change from baseline to 2 years was estimated.~Estimates presented here are based on multiple imputation of missing values."|||10.7|-6.9|0.68
91548450|NCT01999075|182978103|SUPERIORITY||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-1.92|2.18||||||Difference in change in peak cough flow (L/min) from baseline to 2 years, between conventional treatment and intervention group.||2.18|-1.92|
91548451|NCT01999075|182978104|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
91548452|NCT01999075|182978105|SUPERIORITY|||||||1|||||||Mixed Models Analysis|||||||1.00
91548453|NCT01999075|182978106|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
91548454|NCT05521308|182978123|SUPERIORITY||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.2|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #2 and Same counts.||1.00|0.20|<0.001
91548455|NCT05521308|182978123|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.02|TWO_SIDED|95.0|0.41|6.05|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #2 preference counts per participant.||6.05|0.41|0.02
91548456|NCT05521308|182978123|SUPERIORITY||Mean Difference (Final Values)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #3 and Same counts.||1.00|0.18|<0.001
91548457|NCT05521308|182978123|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.54|TWO_SIDED|95.0|-1.36|3.55|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #3 preference counts per participant.||3.55|-1.36|.54
91548458|NCT05521308|182978123|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.231|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #2, Variation #3, and Same counts.||1.00|0|.231
91548459|NCT05521308|182978125|SUPERIORITY||Cramer's V|0.14||||0.13|TWO_SIDED||||||Chi-squared|This is to see if there is a difference in preference counts between standard curve, variation #4, and # of times they were rated as the same. -Indoor||||||.13
91548460|NCT05521308|182978125|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED|||||This is to see if there is a difference in preference counts between standard curve, variation #4, and # of time they were rated as the same. -Outdoor|Chi-squared|||||||0.04
91548461|NCT05521308|182978125|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED||||||Chi-squared|||The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors.||||0.04
91548462|NCT05521308|182978126|SUPERIORITY||Effect Size|0.26|||<|0.001|TWO_SIDED|95.0|0.1|1.0|||ANOVA|Initally this is to see if there is a differnce between Unaided, Aided #1 and Aided #2.||Standard Curve vs Variation #4||1.00|0.10|<0.001
91548463|NCT05521308|182978126|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.855|TWO_SIDED|95.0|-2.83|2.35||Post-Hoc Pairwise Comparison|t-test, 2 sided|Standard Curve vs Variation #4||||2.35|-2.83|0.855
91548464|NCT03056040|182978143|NON_INFERIORITY|A difference in percent change in LDH between the ravulizumab and eculizumab treatment groups at Day 183 along with a 2-sided 95% confidence interval (CI) was calculated. Noninferiority margin (NIM) was based on the upper bound of the 95% CI. NIM was 15%.|Treatment Difference|-9.21|||||TWO_SIDED|95.0|-18.84|0.42|||||Treatment difference was estimated for ravulizumab - eculizumab.|Adjusting for a possible 10% dropout rate, a minimum of 192 participants were estimated to provide 90% power to demonstrate noninferiority of ravulizumab to eculizumab.||0.42|-18.84|
91548465|NCT03056040|182978144|NON_INFERIORITY|NIM was based on the upper bound of the 95% CI. NIM was 20%.|Treatment Difference|-5.1|||||TWO_SIDED|95.0|-18.99|8.89|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with BTH was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||8.89|-18.99|
91548466|NCT03056040|182978145|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM margin was -3.|Treatment Difference|1.47|||||TWO_SIDED|95.0|-0.21|3.15|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.15|-0.21|
91548467|NCT03056040|182978146|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|5.5|||||TWO_SIDED|95.0|-4.27|15.68|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants achieving transfusion avoidance was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug||15.68|-4.27|
91548468|NCT03056040|182978147|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|1.4|||||TWO_SIDED|95.0|-10.41|13.31|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with stabilized hemoglobin was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||13.31|-10.41|
91548469|NCT05260684|182978177|OTHER||Hazard Ratio (HR)|1.32||||0.02|TWO_SIDED|95.0|1.05|1.65|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.65|1.05|0.02
91548470|NCT05260684|182978177|OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.79|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.79|0.76|0.47
91765945|NCT04378270|183421311|OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|5.492||0.002|TWO_SIDED|95.0|7.4498|29.9502|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% confidence interval (CI) of the difference is reported. The P value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||29.9502|7.4498|0.0020
91765946|NCT04378270|183421312|OTHER||Mean Difference (Net)|16.67|STANDARD_ERROR_OF_MEAN|4.327||0.0006|TWO_SIDED|95.0|7.8069|25.5331|||t-test, 2 sided|Degrees of freedom (DF)- 28||||25.5331|7.8069|0.0006
91548471|NCT05260684|182978178|OTHER||Hazard Ratio (HR)|1.49|||<|0.001|TWO_SIDED|95.0|1.2|1.87|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.87|1.20|<0.001
91548472|NCT05260684|182978178|OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.79|1.82|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.82|0.79|0.40
91548473|NCT03850678|182978211|SUPERIORITY|||||||0.774|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression speed experiment (instant, fast, slow).||||.774
91548474|NCT03850678|182978211|SUPERIORITY||||||<|0.001|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression channel conditions (4, 8, 16).||||<.001
91548475|NCT03850678|182978211|SUPERIORITY|||||||0.167|||||||ANOVA|||This analysis compared Q10 for those participants who completed the unaided and aided conditions.||||.167
91548476|NCT03850678|182978212|SUPERIORITY|||||||0.741|||||||ANOVA|||Statistical analysis of number of compression channels (unaided, 4 channel, 16 channels)||||.741
91548477|NCT03850678|182978212|SUPERIORITY|||||||0.062||||||Due to Levene's Test for Equality of Variances, equal variances were not assumed.|t-test, 1 sided|||Spatial Release from Masking, unaided.||||.062
91548478|NCT03850678|182978213|SUPERIORITY|||||||0.805|||||||Regression, Linear|||Linear regression of score for the reading span (independent variable) to Q10 (dependent variable, 16 channel compression condition) for the participants who completed the compression channel experiment.||||.805
91548479|NCT04640298|182978218|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91548480|NCT04640298|182978219|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91548481|NCT04640298|182978220|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91548482|NCT05590403|182978291|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (\<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.09|0.83|
91548483|NCT05590403|182978292|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-2.65|||||TWO_SIDED|95.0|-8.54|3.28|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||3.28|-8.54|
91548484|NCT05590403|182978293|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.79|1.02|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.02|0.79|
91548485|NCT05590403|182978294|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-3.95|||||TWO_SIDED|95.0|-10.39|2.53|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||2.53|-10.39|
91548486|NCT05590403|182978295|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.96|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.96|0.73|
91548487|NCT05590403|182978296|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-6.67|||||TWO_SIDED|95.0|-12.26|-1.12|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.12|-12.26|
91548488|NCT05590403|182978297|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.71|0.91|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.91|0.71|
91548489|NCT05590403|182978298|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-7.31|||||TWO_SIDED|95.0|-13.52|-1.09|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.09|-13.52|
91548490|NCT04717492|182978331|OTHER||Cox Proportional Hazard|1.01||||0.962|TWO_SIDED|95.0|0.66|1.54||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to death, or first hospitalization or revascularization event was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.54|0.66|0.962
91548491|NCT04717492|182978333|OTHER||Cox Proportional Hazard|1.11||||0.694|TWO_SIDED|95.0|0.65|1.92||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to CVD-related death or hospitalization/revascularization was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.92|0.65|0.694
91765947|NCT04378270|183421315|OTHER||Mean pain scale|17.87|STANDARD_DEVIATION|2.39||0.0001|TWO_SIDED|95.0|16.5465|19.1935|||t-test, 2 sided|Degrees of freedom (DF)- 14||This procedure calculates the difference of an observed mean (from the assessment collected at the 4 week visit) with a hypothesized mean value (10, a mid level scale score). A significance value (P-value) and 95% Confidence Interval (CI) of the observed mean is reported. The P-value is the probability of obtaining the observed mean in the sample if the null hypothesis value were the true value.||19.1935|16.5465|0.0001
91765948|NCT01236521|183421321|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|0.13||0.0385|TWO_SIDED||||||Mixed Models Analysis|||||||0.0385
91765949|NCT01236521|183421322|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_DEVIATION|0.11||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
91548492|NCT04717492|182978335|OTHER||Cox Proportional Hazard|0.75||||0.476|TWO_SIDED|95.0|0.34|1.66||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to respiratory/COPD-related death or hospitalization was analyzed using Cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.66|0.34|0.476
91765950|NCT01236521|183421323|SUPERIORITY||Median Difference (Net)|0.39|STANDARD_DEVIATION|0.15||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.0740
91765951|NCT03890588|183421333|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|95.0|0.91|1.51|||Mixed Models Analysis|||||1.51|.91|.21
91765952|NCT03890588|183421334|SUPERIORITY||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.11||0.61|TWO_SIDED|95.0|0.76|1.18|||Mixed Models Analysis|||||1.18|.76|.61
91548493|NCT06393088|182978373|SUPERIORITY|It was calculated that 24 participants randomized 1:1 between 2 arms would have at least an 85% power to detect a difference in pain relief of 30 points as measured using a Visual Analog Device. The actual difference in the mean of the change in pain level, as measured using a Visual Analog Scale, between the two independent groups is 41.67. Results of the post trial calculation was a 95.7% power to detect the difference in pain relief using 29 randomized participants.|Mean Difference (Net)|41.67|||<|0.01|TWO_SIDED|95.0|20.15|61.67||The threshold is P-value \<.0.05 for statistical significance A bootstrap N=20,000 was used for all estimates|t-test, 2 sided|||"Null Hypothesis:~There is not a statistically significant difference in nociceptive musculoskeletal pain when using an IR REHAB device when compared with a sham (placebo) device as a therapy in an approved and standardized clinical protocol."||61.67|20.15|<0.01
91548494|NCT01000961|182978448|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104|Mean Difference (Final Values)|0.0785||||0.0001|TWO_SIDED|95.8|0.0107|0.1464|||t-test, 1 sided||95.8% confidence interval was used instead of 95% to take into account a sample size re-estimation calculation that was performed after 20 patients were enrolled.|16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.||0.1464|0.0107|0.0001
91548495|NCT01000961|182978449|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.4|||||TWO_SIDED|95.0|1.17|1.67||||||||1.67|1.17|
91548496|NCT01000961|182978450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.0|||||TWO_SIDED|95.0|90.0|150.0||||||||150|90|
91548497|NCT01000961|182978451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.03|||||TWO_SIDED|95.0|1.75|2.39||||||||2.39|1.75|
91548498|NCT05089734|182978452|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0534|TWO_SIDED|95.0|0.68|1.04||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.04|0.68|0.0534
91548499|NCT05089734|182978453|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1938|TWO_SIDED|95.0|0.77|1.11||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.11|0.77|0.1938
91548500|NCT05089734|182978454|SUPERIORITY||Difference in Proportions|-4.3||||0.9255|TWO_SIDED|95.0|-10.1|1.5||The 1-sided p-value is calculated using Cochran Mantel-Haenszel test adjusted for randomization stratification factors of histology, and best response to last prior immune therapy received.|Cochran-Mantel-Haenszel|||||1.5|-10.1|0.9255
91548501|NCT05089734|182978459|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.002|TWO_SIDED|95.0|0.61|0.91||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.91|0.61|0.0020
91765953|NCT03890588|183421335|SUPERIORITY||Risk Ratio (RR)|0.98|STANDARD_ERROR_OF_MEAN|0.08||0.84|TWO_SIDED|95.0|0.84|1.15|||Mixed Models Analysis|||||1.15|0.84|.84
91765954|NCT03890588|183421336|SUPERIORITY||Risk Ratio (RR)|1.0|STANDARD_ERROR_OF_MEAN|0.11||0.99|TWO_SIDED|95.0|0.8|1.24|||Mixed Models Analysis|||||1.24|.8|.99
91765955|NCT03890588|183421337|SUPERIORITY||Risk Ratio (RR)|1.02|STANDARD_ERROR_OF_MEAN|0.12||0.86|TWO_SIDED|95.0|0.79|1.32|||Mixed Models Analysis|||||1.32|.79|.86
91548502|NCT05089734|182978460|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0125|TWO_SIDED|95.0|0.66|0.97||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.97|0.66|0.0125
91548503|NCT04873401|182978463|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.928|TWO_SIDED|95.0|0.39|2.79|||Regression, Logistic|||||2.79|0.39|0.928
91548504|NCT04873401|182978464|SUPERIORITY||Median Difference (Final Values)|-0.173|STANDARD_ERROR_OF_MEAN|0.147||0.24|TWO_SIDED|95.0|-0.24|0.115|||Regression, Linear|||||0.115|-0.24|0.240
91548505|NCT04873401|182978465|SUPERIORITY||Slope|0.1171|STANDARD_ERROR_OF_MEAN|0.062||0.367|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.367
91548506|NCT04873401|182978466|SUPERIORITY||Slope|0.171|STANDARD_ERROR_OF_MEAN|0.062||0.005|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.005
91548507|NCT03457142|182978471|OTHER|No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.|grade 3+ treatment related AE rate|0.33|||||TWO_SIDED|90.0|0.17|0.54||||||||0.54|0.17|
91548508|NCT04533347|182978498|SUPERIORITY|||||||0.1879|TWO_SIDED|95.0|||||Fisher Exact|||Assuming an 85% clinical recovery rate in the TQ group and a 70% clinical recovery rate in the placebo group, sample sizes of 125 per treatment group were expected to achieve 80% power with a two-sided alpha of 0.05.||||0.1879
91548509|NCT05520190|182978504|SUPERIORITY||Standardized Response Mean|-0.47|||||TWO_SIDED||||||||Baseline Attitude score - 1-month Attitude score / SD of average change|||||
91548510|NCT05520190|182978505|SUPERIORITY||Standardized Response Mean|-0.23|||||TWO_SIDED||||||||Baseline Norm score - 1-month Norm score / SD of average change|||||
91548511|NCT05520190|182978506|SUPERIORITY||Standardized Response Mean|-0.03|||||TWO_SIDED||||||||Baseline Perceived Behavioral Control score - 1-month Perceived Behavioral Control score / SD of average change|||||
91548512|NCT05520190|182978507|SUPERIORITY||Standardized Response Mean|-0.16|||||TWO_SIDED||||||||Baseline Intention score - 1-month Intention score / SD of average change|||||
91548513|NCT05520190|182978508|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinks per day - 1-month drinks per day / avg change in drinks per day|||||
91548514|NCT05520190|182978509|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinking days - 1-month drinking days / SD of avg change in drinking days|||||
91548515|NCT05520190|182978510|SUPERIORITY||Standardized Response Mean|0.3|||||TWO_SIDED||||||||Baseline binge drinking days - 1-month binge drinking days / avg change in binge drinking days|||||
91548516|NCT05520190|182978511|SUPERIORITY||Standardized Response Mean|1.23|||||TWO_SIDED||||||||Baseline depression - 1-month depression / SD of avg change in depression|||||
91548517|NCT05520190|182978512|SUPERIORITY||Standardized Response Mean|1.06|||||TWO_SIDED||||||||Baseline anxiety - 1-month anxiety / SD avg change in anxiety|||||
91765956|NCT02052752|183421338|SUPERIORITY_OR_OTHER|||||||0.283||95.0|||||ANCOVA|||The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population||||0.283
91548518|NCT05520190|182978513|SUPERIORITY||Standardized Response Mean|0.9|||||TWO_SIDED||||||||Baseline PTSD - 1-month PTSd / SD avg change in PTSD|||||
91548519|NCT05520190|182978514|SUPERIORITY||Standardized Response Mean|0.6|||||TWO_SIDED||||||||Baseline insomnia - 1-month insomnia / SD avg change in insomnia|||||
91548520|NCT05520190|182978515|SUPERIORITY||Standardized Response Mean|0.58|||||TWO_SIDED||||||||Baseline Alcohol Screen - 1-month Alcohol Screen / SD avg change|||||
91548521|NCT05520190|182978516|SUPERIORITY||Standardized Response Mean|-0.39|||||TWO_SIDED||||||||Baseline behavioral beliefs - 1-month behavioral beliefs / avg change in behavioral beliefs|||||
91548522|NCT05520190|182978517|SUPERIORITY||Standardized Response Mean|-0.62|||||TWO_SIDED||||||||Baseline normative beliefs - 1-month normative beliefs / SD avg change in normative beliefs|||||
91548523|NCT05520190|182978518|SUPERIORITY||Standardized Response Mean|-0.83|||||TWO_SIDED||||||||Baseline control beliefs - 1-month control beliefs / SD avg change in control beliefs|||||
91548524|NCT02921230|182978560|SUPERIORITY|||||||0.0077|||||||Chi-squared|||||||0.0077
91548525|NCT04274764|182978577|OTHER|||||||0.7399|||||||Chi-squared|||||||0.7399
91548526|NCT00450658|182978624|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||0.0018|TWO_SIDED|95.0|3.0|15.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjects developing UGI (gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative proportion of subjects developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||15.9|3.0|0.0018
91548527|NCT00450658|182978625|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.2||||0.0051|TWO_SIDED|95.0|1.9|14.4|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||||14.4|1.9|0.0051
91765957|NCT03201419|183421344|SUPERIORITY||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.54|-0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.07|-0.54|
91548528|NCT00450658|182978626|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.9||||0.0017|TWO_SIDED|95.0|0.8|7.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||The secondary efficacy endpoint was the proportion of subjects developing duodenal ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative proportion of subjects developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||7.1|0.8|0.0017
91548529|NCT00999804|182978691|SUPERIORITY_OR_OTHER_LEGACY||proportion of pCR|0.25|||||TWO_SIDED||||||||No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.|"The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.~The analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants."||||
91548530|NCT00999804|182978692|SUPERIORITY_OR_OTHER_LEGACY||proportion of patients with AE|0.72|||||TWO_SIDED||||||||61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.|This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.||||
91548531|NCT00999804|182978693|SUPERIORITY_OR_OTHER_LEGACY||proportion of tpCR in 24 weeks arm|0.1|||||TWO_SIDED|||||||||No comparison between the two arms is required.||||
91548532|NCT00999804|182978694|SUPERIORITY_OR_OTHER_LEGACY||proportion of CR+PR in 24 weeks arm|0.69|||||TWO_SIDED|||||||||No comparison between the 2 arm is required for this study.||||
91548533|NCT05229146|182978695|SUPERIORITY|||||||0.191||||||No adjustment for multiple comparisons.|t-test, 1 sided|t-statistic = .913, df = 10||One-sided paired-samples t-test comparing baseline to responses immediately following the intervention (approximately one week after baseline).||||.191
91548534|NCT05229146|182978695|SUPERIORITY|||||||0.043||||||Not adjusted for multiple comparisons.|t-test, 1 sided|t-statistic = 1.92, df = 9||One-sided paired-samples t-test comparing baseline to responses at two week follow-up (approximately four weeks after baseline).||||.043
91548535|NCT05229146|182978696|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.319|TWO_SIDED|||||No adjustments were made. DF = 15.|t-test, 2 sided|||Comparison is between future orientation subscale pre- and post-subscale scores.||||.319
91548536|NCT05229146|182978696|SUPERIORITY||Mean Difference (Final Values)|-0.711||||0.488|TWO_SIDED||||||t-test, 2 sided|No adjustments were made. DF = 15.||Comparison between immediate-orientation subscales.||||.488
91548537|NCT05229146|182978697|SUPERIORITY||Mean Difference (Final Values)|0.438||||0.34|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a paired-samples one-sided t-test comparing positive parenting before the intervention to after the intervention.||||.34
91548538|NCT05229146|182978697|SUPERIORITY||Mean Difference (Final Values)|-0.363||||0.362|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a one-sided paired-samples t-test to compare negative parenting before and after the intervention.||||.362
91548539|NCT05229146|182978698|SUPERIORITY||Mean Difference (Final Values)|-3.77|||<|0.001|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15||Used a one-sided paired samples t-test to examine changes in the parental involvement subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||<.001
91765958|NCT03201419|183421344|SUPERIORITY||Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.46|-0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.02|-0.46|
91765959|NCT03201419|183421344|SUPERIORITY||Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.36|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.36|
91765960|NCT03201419|183421344|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.23|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.23|
91765961|NCT03201419|183421344|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.14|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.14|
91548540|NCT05229146|182978698|SUPERIORITY||Median Difference (Final Values)|-1.14||||0.137|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the positive parenting subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.137
91548541|NCT05229146|182978698|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.018|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the inconsistent discipline subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.018
91548542|NCT05229146|182978698|SUPERIORITY||Mean Difference (Final Values)|2.39||||0.015|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the use of corporal punishment subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.015
91548543|NCT05229146|182978698|SUPERIORITY||Mean Difference (Final Values)|2.23||||0.021|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the poor parental monitoring/supervision subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.021
91548544|NCT05229146|182978699|SUPERIORITY||Mean Difference (Final Values)|0.878||||0.197|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15||Used a one-sided paired-samples t-test to examine changes in emotion regulation subscale from pre-intervention to post-intervention.||||.197
91548545|NCT05229146|182978699|SUPERIORITY||Mean Difference (Final Values)|0.857||||0.203|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15.||Used a one-sided paired-samples t-test to examine changes in lability/negativity subscale from pre-intervention to post-intervention.||||.203
91548546|NCT05071807|182978705|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-1.17|1.33|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and BMI (kg/m2)||To detect a 1.2 percentage point (standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power (α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group)||1.33|-1.17|
91548547|NCT05071807|182978706|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-12.3|-2.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.1|-12.3|
91548548|NCT05071807|182978707|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-0.8|2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||2.9|-0.8|
91548549|NCT05071807|182978708|SUPERIORITY||Mean Difference (Net)|-16.4|||||TWO_SIDED|95.0|-30.0|-2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.9|-30.0|
91548550|NCT05071807|182978709|SUPERIORITY||Mean Difference (Net)|-75.3|||||TWO_SIDED|95.0|-144.0|-6.93|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Total LDL particle mean difference||-6.93|-144|
91548551|NCT05071807|182978709|SUPERIORITY||Mean Difference (Net)|-27.9|||||TWO_SIDED|95.0|-69.3|13.4|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||For Large LDL particle subclass||13.4|-69.3|
91548552|NCT05071807|182978710|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.56|0.75|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||Results for total HDL particle count||0.75|-0.56|
91548553|NCT05071807|182978710|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.75|0.8||||Adjusted for baseline value, age, sex, and BMI||Results for Small HDL particles||0.80|-0.75|
91548554|NCT05071807|182978710|SUPERIORITY||Mean Difference (Net)|-0.33|||||TWO_SIDED|95.0|-0.85|0.19|||Regression, Linear|Adjusted for baseline value, age, sex, and BMI||Results for Medium HDL||0.19|-0.85|
91548555|NCT05071807|182978711|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-3.09|3.13|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results from brachial systolic blood pressure are reported below||3.13|-3.09|
91548556|NCT05071807|182978711|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.67|2.07|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for Brachial Diastolic Blood pressure||2.07|-1.67|
91548557|NCT05071807|182978712|SUPERIORITY||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-3.24|2.28|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central systolic blood pressure||2.28|-3.24|
91548558|NCT05071807|182978712|SUPERIORITY||Median Difference (Net)|0.21|||||TWO_SIDED|95.0|-1.69|2.1|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central diastolic blood pressure||2.10|-1.69|
91548559|NCT05071807|182978713|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.26|0.24|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.24|-0.26|
91548560|NCT05071807|182978714|SUPERIORITY||Mean Difference (Net)|-1.65|||||TWO_SIDED|95.0|-4.25|0.95|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.95|-4.25|
91548561|NCT05071807|182978715|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.6|3.0|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||3.0|-0.6|
91548562|NCT05071807|182978716|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-2.3|1.6|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||1.6|-2.3|
91548563|NCT05071807|182978717|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.1|0.0|
91548564|NCT05071807|182978718|SUPERIORITY||Mean Difference (Net)|9.4|||||TWO_SIDED|95.0|5.0|13.7||When a significant group by time point interaction was detected, post hoc testing was conducted and the Tukey-Kramer method was used to adjust for multiple comparisons.|Mixed Models Analysis|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||13.7|5.0|
91548565|NCT05071807|182978719|SUPERIORITY||Median Difference (Net)|-8.1|||||TWO_SIDED|95.0|-14.5|-1.7|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-1.7|-14.5|
91765962|NCT03201419|183421344|SUPERIORITY||Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.07|
91765963|NCT03201419|183421345|SUPERIORITY||Mean Difference|-0.139||||0.4214|TWO_SIDED|95.0|-0.48|0.201||Threshold for significance at 0.05 level.|MMRM|||||0.201|-0.480|0.4214
91765964|NCT03201419|183421345|SUPERIORITY||Mean Difference|-0.587||||0.0101|TWO_SIDED|95.0|-1.034|-0.141||Threshold for significance at 0.05 level.|MMRM|||||-0.141|-1.034|0.0101
91548566|NCT05071807|182978720|SUPERIORITY||Mean Difference (Net)|-25.5|||||TWO_SIDED|95.0|-98.6|47.5|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results for medium subclass; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||47.5|-98.6|
91548567|NCT05071807|182978720|SUPERIORITY||Mean Difference (Net)|1.86|||||TWO_SIDED|95.0|-91.8|95.5|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||Results for Small LDL particles; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||95.5|-91.8|
91548568|NCT05071807|182978721|SUPERIORITY||Mean Difference (Net)|0.35|||||TWO_SIDED|95.0|0.07|0.63|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.63|0.07|
91548569|NCT03158714|182978765|SUPERIORITY||Mean Difference (Net)|0.033||||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.005
91548570|NCT03158714|182978765|SUPERIORITY||Mean Difference (Net)|0.02||||0.101|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.101
91548571|NCT03158714|182978766|SUPERIORITY||Mean Difference (Net)|3.96|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
91548572|NCT03158714|182978766|SUPERIORITY||Mean Difference (Net)|4.09|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
91765965|NCT03201419|183421345|SUPERIORITY||Mean Difference|-0.148||||0.5203|TWO_SIDED|95.0|-0.599|0.304||Threshold for significance at 0.05 level.|MMRM|||||0.304|-0.599|0.5203
91765966|NCT03201419|183421345|SUPERIORITY||Mean Difference|0.055||||0.8483|TWO_SIDED|95.0|-0.508|0.617||Threshold for significance at 0.05 level.|MMRM|||||0.617|-0.508|0.8483
91548573|NCT03158714|182978767|SUPERIORITY||Mean Difference (Net)|0.343||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.003
91548574|NCT03158714|182978767|SUPERIORITY||Mean Difference (Net)|0.172||||0.152|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.152
91548575|NCT01160211|182978771|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0063|TWO_SIDED|95.0|0.45|0.88||Pike estimate of the treatment hazard ratio, \<1 indicates a lower risk compared with trastuzumab + AI.|Log Rank|using a two-sided stratified log-rank test (based on stratification factors)||Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.||0.88|0.45|0.0063
91548576|NCT01160211|182978773|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.44|0.79||||||||0.79|0.44|
91548577|NCT01160211|182978773|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.66|1.15||||||||1.15|0.66|
91548578|NCT01160211|182978773|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.51|0.92||||||||0.92|0.51|
91548579|NCT01160211|182978779|SUPERIORITY||Least square difference|-1.79|STANDARD_ERROR_OF_MEAN|2.111|||TWO_SIDED|95.0|-5.95|2.36||||||FACT-B total score||2.36|-5.95|
91548580|NCT01160211|182978779|SUPERIORITY||Least square difference|-3.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-8.09|0.29||||||FACT-B total score||0.29|-8.09|
91548581|NCT01160211|182978779|SUPERIORITY||Least square difference|-1.5|STANDARD_ERROR_OF_MEAN|1.739|||TWO_SIDED|95.0|-4.92|1.92||||||FACT-G total score||1.92|-4.92|
91548582|NCT01160211|182978779|SUPERIORITY||Least square difference|-3.1|STANDARD_ERROR_OF_MEAN|1.751|||TWO_SIDED|95.0|-6.55|0.34||||||FACT-G total score||0.34|-6.55|
91548583|NCT01160211|182978779|SUPERIORITY||Least square difference|-2.7|STANDARD_ERROR_OF_MEAN|1.502|||TWO_SIDED|95.0|-5.66|0.25||||||FACT-B trial outcome index (TOI)||0.25|-5.66|
91548584|NCT01160211|182978779|SUPERIORITY||Least square difference|-3.61|STANDARD_ERROR_OF_MEAN|1.512|||TWO_SIDED|95.0|-6.59|-0.64||||||FACT-B trial outcome index (TOI)||-0.64|-6.59|
91548585|NCT01160211|182978779|SUPERIORITY||Least square difference|-1.46|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.82|-0.11||||||Physical well-being (PWB)||-0.11|-2.82|
91765967|NCT03201419|183421345|SUPERIORITY||Mean Difference|-0.147||||0.6357|TWO_SIDED|95.0|-0.759|0.464||Threshold for significance at 0.05 level.|MMRM|||||0.464|-0.759|0.6357
91765968|NCT03201419|183421345|SUPERIORITY||Mean Difference|0.25||||0.2222|TWO_SIDED|95.0|-0.152|0.652||Threshold for significance at 0.05 level.|MMRM|||||0.652|-0.152|0.2222
91765969|NCT03201419|183421346|SUPERIORITY||Mean Difference|-0.166||||0.2909|TWO_SIDED|95.0|-0.474|0.143||Threshold for significance at 0.05 level.|MMRM|||||0.143|-0.474|0.2909
91765970|NCT03201419|183421346|SUPERIORITY||Mean Difference|-0.418||||0.044|TWO_SIDED|95.0|-0.824|-0.011||Threshold for significance at 0.05 level.|MMRM|||||-0.011|-0.824|0.0440
91765971|NCT03201419|183421346|SUPERIORITY||Mean Difference|0.128||||0.5438|TWO_SIDED|95.0|-0.288|0.545||Threshold for significance at 0.05 level.|MMRM|||||0.545|-0.288|0.5438
91765972|NCT03201419|183421346|SUPERIORITY||Mean Difference|0.441||||0.096|TWO_SIDED|95.0|-0.079|0.962||Threshold for significance at 0.05 level.|MMRM|||||0.962|-0.079|0.0960
91548586|NCT01160211|182978779|SUPERIORITY||Least square difference|-1.54|STANDARD_ERROR_OF_MEAN|0.693|||TWO_SIDED|95.0|-2.9|-0.18||||||Physical well-being (PWB)||-0.18|-2.90|
91548587|NCT01160211|182978779|SUPERIORITY||Least square difference|0.39|STANDARD_ERROR_OF_MEAN|0.711|||TWO_SIDED|95.0|-1.01|1.79||||||Social family wellbeing (SWB)||1.79|-1.01|
91548588|NCT01160211|182978779|SUPERIORITY||Least square difference|-0.55|STANDARD_ERROR_OF_MEAN|0.715|||TWO_SIDED|95.0|-1.96|0.86||||||Social family wellbeing (SWB)||0.86|-1.96|
91765973|NCT03201419|183421346|SUPERIORITY||Mean Difference|-0.04||||0.8826|TWO_SIDED|95.0|-0.568|0.488||Threshold for significance at 0.05 level.|MMRM|||||0.488|-0.568|0.8826
91765974|NCT03201419|183421346|SUPERIORITY||Mean Difference|0.394||||0.0344|TWO_SIDED|95.0|0.029|0.759||Threshold for significance at 0.05 level.|MMRM|||||0.759|0.029|0.0344
91765975|NCT03201419|183421347|SUPERIORITY||Mean Difference|-0.132||||0.4732|TWO_SIDED|95.0|-0.496|0.231||Threshold for significance at 0.05 level.|MMRM|||||0.231|-0.496|0.4732
91765976|NCT03201419|183421347|SUPERIORITY||Mean Difference|-0.224||||0.3394|TWO_SIDED|95.0|-0.685|0.237||Threshold for significance at 0.05 level.|MMRM|||||0.237|-0.685|0.3394
91765977|NCT03201419|183421347|SUPERIORITY||Mean Difference|-0.012||||0.96|TWO_SIDED|95.0|-0.488|0.463||Threshold for significance at 0.05 level.|MMRM|||||0.463|-0.488|0.9600
91765978|NCT03201419|183421347|SUPERIORITY||Mean Difference|0.463||||0.1131|TWO_SIDED|95.0|-0.111|1.037||Threshold for significance at 0.05 level.|MMRM|||||1.037|-0.111|0.1131
91765979|NCT03201419|183421347|SUPERIORITY||Mean Difference|-0.124||||0.6853|TWO_SIDED|95.0|-0.729|0.48||Threshold for significance at 0.05 level.|MMRM|||||0.480|-0.729|0.6853
91765980|NCT03201419|183421347|SUPERIORITY||Mean Difference|0.166||||0.4364|TWO_SIDED|95.0|-0.254|0.587||Threshold for significance at 0.05 level.|MMRM|||||0.587|-0.254|0.4364
91765981|NCT03201419|183421348|SUPERIORITY||Mean Difference|-0.299||||0.1106|TWO_SIDED|95.0|-0.667|0.069||Threshold for significance at 0.05 level.|MMRM|||||0.069|-0.667|0.1106
91765982|NCT03201419|183421348|SUPERIORITY||Mean Difference|-0.163||||0.5005|TWO_SIDED|95.0|-0.639|0.313||Threshold for significance at 0.05 level.|MMRM|||||0.313|-0.639|0.5005
91765983|NCT03201419|183421348|SUPERIORITY||Mean Difference|0.107||||0.6604|TWO_SIDED|95.0|-0.372|0.586||Threshold for significance at 0.05 level.|MMRM|||||0.586|-0.372|0.6604
91765984|NCT03201419|183421348|SUPERIORITY||Mean Difference|0.283||||0.3178|TWO_SIDED|95.0|-0.275|0.842||Threshold for significance at 0.05 level.|MMRM|||||0.842|-0.275|0.3178
91765985|NCT03201419|183421348|SUPERIORITY||Mean Difference|-0.096||||0.7561|TWO_SIDED|95.0|-0.701|0.51||Threshold for significance at 0.05 level.|MMRM|||||0.510|-0.701|0.7561
91765986|NCT03201419|183421348|SUPERIORITY||Mean Difference|0.037||||0.8614|TWO_SIDED|95.0|-0.378|0.452||Threshold for significance at 0.05 level.|MMRM|||||0.452|-0.378|0.8614
91548589|NCT01160211|182978779|SUPERIORITY||Least square difference|0.54|STANDARD_ERROR_OF_MEAN|0.568|||TWO_SIDED|95.0|-0.57|1.66||||||Emotional wellbeing (EWB)||1.66|-0.57|
91548590|NCT01160211|182978779|SUPERIORITY||Least square difference|0.4|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|95.0|-0.72|1.53||||||Emotional wellbeing (EWB)||1.53|-0.72|
91765987|NCT03201419|183421349|SUPERIORITY||Odds Ratio (OR)|1.759||||0.117|TWO_SIDED|95.0|0.869|3.56||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.560|0.869|0.117
91765988|NCT03201419|183421349|SUPERIORITY||Odds Ratio (OR)|2.505||||0.048|TWO_SIDED|95.0|1.01|6.214||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.214|1.010|0.048
91765989|NCT03201419|183421349|SUPERIORITY||Odds Ratio (OR)|1.42||||0.46|TWO_SIDED|95.0|0.56|3.602||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.602|0.560|0.460
91765990|NCT03201419|183421349|SUPERIORITY||Odds Ratio (OR)|1.704||||0.367|TWO_SIDED|95.0|0.535|5.427||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.427|0.535|0.367
91548591|NCT01160211|182978779|SUPERIORITY||Least square difference|-0.99|STANDARD_ERROR_OF_MEAN|0.646|||TWO_SIDED|95.0|-2.26|0.28||||||Functional wellbeing (FWB)||0.28|-2.26|
91548592|NCT01160211|182978779|SUPERIORITY||Least square difference|-1.32|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|95.0|-2.6|-0.04||||||Functional wellbeing (FWB)||-0.04|-2.60|
91548593|NCT01160211|182978779|SUPERIORITY||Least square difference|-0.35|STANDARD_ERROR_OF_MEAN|0.665|||TWO_SIDED|95.0|-1.66|0.95||||||Breast cancer subscale (BCS)||0.95|-1.66|
91548594|NCT01160211|182978779|SUPERIORITY||Least square difference|-0.83|STANDARD_ERROR_OF_MEAN|0.668|||TWO_SIDED|95.0|-2.14|0.48||||||Breast cancer subscale (BCS)||0.48|-2.14|
91548595|NCT05409183|182978866|OTHER||LS Mean of Treatment Difference|26.473|STANDARD_ERROR_OF_MEAN|9.216||0.0032|TWO_SIDED|95.0|7.847|45.099|||ANCOVA|||||45.099|7.847|0.0032
91765991|NCT03201419|183421349|SUPERIORITY||Odds Ratio (OR)|1.689||||0.407|TWO_SIDED|95.0|0.489|5.825||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.825|0.489|0.407
91765992|NCT03201419|183421349|SUPERIORITY||Odds Ratio (OR)|1.069||||0.876|TWO_SIDED|95.0|0.462|2.473||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.473|0.462|0.876
91765993|NCT03201419|183421350|SUPERIORITY||Odds Ratio (OR)|0.971||||0.937|TWO_SIDED|95.0|0.47|2.005||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.005|0.470|0.937
91765994|NCT03201419|183421350|SUPERIORITY||Odds Ratio (OR)|4.738||||0.028|TWO_SIDED|95.0|1.183|18.968||Threshold for significance at 0.05 level.|Regression, Logistic|||||18.968|1.183|0.028
91765995|NCT03201419|183421350|SUPERIORITY||Odds Ratio (OR)|0.513||||0.166|TWO_SIDED|95.0|0.2|1.318||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.318|0.200|0.166
91765996|NCT03201419|183421350|SUPERIORITY||Odds Ratio (OR)|0.433||||0.174|TWO_SIDED|95.0|0.129|1.447||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.447|0.129|0.174
91765997|NCT03201419|183421350|SUPERIORITY||Odds Ratio (OR)|1.425||||0.608|TWO_SIDED|95.0|0.369|5.512||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.512|0.369|0.608
91765998|NCT03201419|183421350|SUPERIORITY||Odds Ratio (OR)|0.553||||0.171|TWO_SIDED|95.0|0.237|1.292||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.292|0.237|0.171
91765999|NCT03201419|183421351|SUPERIORITY||Odds Ratio (OR)|0.928||||0.85|TWO_SIDED|95.0|0.43|2.003||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.003|0.430|0.850
91766000|NCT03201419|183421351|SUPERIORITY||Odds Ratio (OR)|2.261||||0.15|TWO_SIDED|95.0|0.745|6.862||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.862|0.745|0.150
91548596|NCT03241459|182978878|NON_INFERIORITY|15.0% is the absolute noninferiority margin (50% of the difference in primary patency rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|-3.7||||0.0029|ONE_SIDED|97.5|-11.7|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary effectiveness endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-11.7|0.0029
91548597|NCT03241459|182978879|NON_INFERIORITY|10.0% is the absolute noninferiority margin (50% of the difference in primary safety endpoint rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|2.0|||<|0.0001|ONE_SIDED|97.5|-4.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 10% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-4.1|<.0001
91548598|NCT03241459|182978880|SUPERIORITY|||||||0.579|TWO_SIDED|95.0||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||0.579
91548599|NCT03241459|182978881|SUPERIORITY|||||||1||||||Both arms demonstrated 100% success, therefore, Fisher's exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.00
91548600|NCT03241459|182978882|SUPERIORITY|||||||1||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.000
91766001|NCT03201419|183421351|SUPERIORITY||Odds Ratio (OR)|1.283||||0.632|TWO_SIDED|95.0|0.462|3.566||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.566|0.462|0.632
91548601|NCT03241459|182978883|SUPERIORITY|||||||0.494||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||||||0.494
91548602|NCT03241459|182978884|NON_INFERIORITY|The Farrington and Manning test for noninferiority of proportions at a one-sided significance level of 0.025.|Difference in percentage|-1.9||||0.0059|ONE_SIDED|97.5|-12.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test|||The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:|||-12.1|0.0059
91548603|NCT03241459|182978885|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 12 months.||||||0.699||||||12-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||0.699
91548604|NCT03241459|182978885|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 24 months.||||||1||||||24-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||1.0
91548605|NCT03241459|182978886|SUPERIORITY|||||||0.699|TWO_SIDED|95.0||||6-Month P-Value|Fisher Exact|||||||0.699
91548606|NCT03241459|182978886|SUPERIORITY|||||||0.447||||||12-Month P-Value|Fisher Exact|||||||0.447
91548607|NCT03241459|182978886|SUPERIORITY|||||||0.589||||||24-Month P-Value|Fisher Exact|||||||0.589
91548608|NCT03241459|182978887|SUPERIORITY|||||||1||||||P-Value at 6-Months|Fisher Exact|||||||1.0
91548609|NCT03241459|182978887|SUPERIORITY|||||||0.823||||||P-Value at 12-Months|Fisher Exact|||||||0.823
91548610|NCT03241459|182978887|SUPERIORITY|||||||0.454||||||P-Value at 24-Months|Fisher Exact|||||||0.454
91548611|NCT03241459|182978888|SUPERIORITY|||||||0.535||||||P-Value at 6-Months|Fisher Exact|||||||0.535
91548612|NCT03241459|182978888|SUPERIORITY|||||||0.86||||||P-Value at 12-Months|Fisher Exact|||||||0.860
91548613|NCT03241459|182978888|SUPERIORITY|||||||0.39||||||P-Value at 24-Months|Fisher Exact|||||||0.390
91548614|NCT03241459|182978889|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 6 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
91548615|NCT03241459|182978889|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 12 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
91548616|NCT03241459|182978889|SUPERIORITY|||||||1||||||P-Value at 24-Months|Fisher Exact|||||||1.0
91548617|NCT03241459|182978890|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91548618|NCT03241459|182978890|SUPERIORITY|||||||0.472||||||P-Value at 24-Months|Fisher Exact|||||||0.472
91548619|NCT03241459|182978891|SUPERIORITY|||||||0.193||||||P-Value for change in Rutherford Classification from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.193
91548620|NCT03241459|182978891|SUPERIORITY|||||||0.14||||||P-Value for change in Rutherford Classification from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.140
91548621|NCT03241459|182978891|SUPERIORITY|||||||0.372||||||P-Value for change in Rutherford Classification from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.372
91548622|NCT03241459|182978891|SUPERIORITY|||||||0.104||||||P-Value for change in Rutherford Classification from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.104
91548623|NCT03241459|182978892|SUPERIORITY|||||||0.32||||||P-Value for change in PARC from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.320
91548624|NCT03241459|182978892|SUPERIORITY|||||||0.132||||||P-Value for change in PARC from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.132
91766002|NCT03201419|183421351|SUPERIORITY||Odds Ratio (OR)|0.583||||0.363|TWO_SIDED|95.0|0.183|1.863||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.863|0.183|0.363
91766003|NCT03201419|183421351|SUPERIORITY||Odds Ratio (OR)|0.691||||0.555|TWO_SIDED|95.0|0.203|2.359||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.359|0.203|0.555
91766004|NCT03201419|183421351|SUPERIORITY||Odds Ratio (OR)|0.991||||0.984|TWO_SIDED|95.0|0.408|2.405||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.405|0.408|0.984
91548625|NCT03241459|182978892|SUPERIORITY|||||||0.248||||||P-Value for change in PARC from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.248
91548626|NCT03241459|182978892|SUPERIORITY|||||||0.194||||||P-Value for change in PARC from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.194
91548627|NCT03241459|182978893|SUPERIORITY|||||||0.789||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 6-Months|Fisher Exact|||||||0.789
91548628|NCT03241459|182978893|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91548629|NCT03241459|182978893|SUPERIORITY|||||||0.041||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 12-Months.|Fisher Exact|||||||0.041
91548630|NCT03241459|182978893|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 12-Months.|Fisher Exact|||||||1.0
91548631|NCT03241459|182978893|SUPERIORITY|||||||0.401||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 24-Months.|Fisher Exact|||||||0.401
91548632|NCT03241459|182978893|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 24-Months.|Fisher Exact|||||||1.0
91548633|NCT03241459|182978894|OTHER|||||||0.995||||||P-value for change in WIQ from BL to 1-Month: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.995
91548634|NCT03241459|182978894|SUPERIORITY|||||||0.158||||||P-value for change in WIQ from BL to 1-month: Walking distance score|Wilcoxon (Mann-Whitney)|||||||0.158
91548635|NCT03241459|182978894|SUPERIORITY|||||||0.695||||||P-value for change in WIQ from BL to 1-month: Walking speed score|Wilcoxon (Mann-Whitney)|||||||0.695
91548636|NCT03241459|182978894|SUPERIORITY|||||||0.086||||||P-value for change in WIQ from BL to 1-Month: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.086
91548637|NCT03241459|182978894|SUPERIORITY|||||||0.331||||||P-value for change in WIQ from BL to 12-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.331
91548638|NCT03241459|182978894|SUPERIORITY|||||||0.58||||||P-value for change in WIQ from BL to 12-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.580
91548639|NCT03241459|182978894|SUPERIORITY|||||||0.563||||||P-value for change in WIQ from BL to 12-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.563
91548640|NCT03241459|182978894|SUPERIORITY|||||||0.27||||||P-value for change in WIQ from BL to 12-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.270
91766005|NCT03201419|183421352|SUPERIORITY||Odds Ratio (OR)|2.462||||0.046|TWO_SIDED|95.0|1.017|5.961||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.961|1.017|0.046
91548641|NCT03241459|182978894|SUPERIORITY|||||||0.869||||||P-value for change in WIQ from BL to 24-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.869
91548642|NCT03241459|182978894|SUPERIORITY|||||||0.837||||||P-value for change in WIQ from BL to 24-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.837
91548643|NCT03241459|182978894|SUPERIORITY|||||||0.674||||||P-value for change in WIQ for BL to 24-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.674
91548644|NCT03241459|182978894|SUPERIORITY|||||||0.563||||||P-value for change in WIQ for BL to 24-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.563
91548645|NCT03241459|182978895|SUPERIORITY|||||||0.237||||||P-value for change in 6MWT from BL to 12-Months|t-test, 2 sided|||||||0.237
91548646|NCT03241459|182978895|SUPERIORITY|||||||0.04||||||P-value for change in 6MWT from BL to 24-Months|t-test, 2 sided|||||||0.040
91548647|NCT03241459|182978896|SUPERIORITY|||||||0.772||||||P-value for change in PAQ from BL to 1-Month: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.772
91548648|NCT03241459|182978896|SUPERIORITY|||||||0.93||||||P-value for change in PAQ from BL to 1-Month: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.930
91548649|NCT03241459|182978896|SUPERIORITY|||||||0.546||||||P-value for change in PAQ from BL to 1-Month: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.546
91548650|NCT03241459|182978896|SUPERIORITY|||||||0.621||||||P-value for change in PAQ from BL to 1-Month: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.621
91548651|NCT03241459|182978896|SUPERIORITY|||||||0.133||||||P-value for change in PAQ from BL to 1-Month: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.133
91548652|NCT03241459|182978896|SUPERIORITY|||||||0.592||||||P-value for change in PAQ from BL to 1-Month: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.592
91548653|NCT03241459|182978896|SUPERIORITY|||||||0.601||||||P-value for change in PAQ from BL to 1-Month: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.601
91548654|NCT03241459|182978896|SUPERIORITY|||||||0.185||||||P-value for change in PAQ from BL to 12-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.185
91548655|NCT03241459|182978896|SUPERIORITY|||||||0.856||||||P-value for change in PAQ from BL to 12-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.856
91548656|NCT03241459|182978896|SUPERIORITY|||||||0.541||||||P-value for change in PAQ from BL to 12-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.541
91548657|NCT03241459|182978896|SUPERIORITY|||||||0.731||||||P-value for change in PAQ from BL to 12-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.731
91548658|NCT03241459|182978896|SUPERIORITY|||||||0.696||||||P-value for change in PAQ from BL to 12-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.696
91548659|NCT03241459|182978896|SUPERIORITY|||||||0.716||||||P-value for change in PAQ from BL to 12-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.716
91766006|NCT03201419|183421352|SUPERIORITY||Odds Ratio (OR)|1.19||||0.745|TWO_SIDED|95.0|0.418|3.386||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.386|0.418|0.745
91766007|NCT03201419|183421352|SUPERIORITY||Odds Ratio (OR)|1.147||||0.79|TWO_SIDED|95.0|0.417|3.155||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.155|0.417|0.790
91766008|NCT03201419|183421352|SUPERIORITY||Odds Ratio (OR)|0.537||||0.293|TWO_SIDED|95.0|0.169|1.71||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.710|0.169|0.293
91766009|NCT03201419|183421352|SUPERIORITY||Odds Ratio (OR)|0.881||||0.843|TWO_SIDED|95.0|0.252|3.076||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.076|0.252|0.843
91766010|NCT03201419|183421352|SUPERIORITY||Odds Ratio (OR)|0.877||||0.763|TWO_SIDED|95.0|0.375|2.053||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.053|0.375|0.763
91766011|NCT03201419|183421353|SUPERIORITY||Odds Ratio (OR)|1.422|||||TWO_SIDED|95.0|0.868|2.597||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.597|0.868|
91766012|NCT03201419|183421353|SUPERIORITY||Odds Ratio (OR)|1.373|||||TWO_SIDED|95.0|0.905|2.45||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.450|0.905|
91766013|NCT03201419|183421353|SUPERIORITY||Odds Ratio (OR)|1.284|||||TWO_SIDED|95.0|0.927|2.264||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.264|0.927|
91766014|NCT03201419|183421353|SUPERIORITY||Odds Ratio (OR)|1.145|||||TWO_SIDED|95.0|0.957|1.896||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.896|0.957|
91766015|NCT03201419|183421353|SUPERIORITY||Odds Ratio (OR)|1.079|||||TWO_SIDED|95.0|0.972|1.638||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.638|0.972|
91766016|NCT03201419|183421353|SUPERIORITY||Odds Ratio (OR)|1.023|||||TWO_SIDED|95.0|0.991|1.313||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.313|0.991|
91766017|NCT03201419|183421354|SUPERIORITY||Mean Difference|0.52||||0.8463|TWO_SIDED|95.0|-4.75|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-4.75|0.8463
91766018|NCT03201419|183421354|SUPERIORITY||Mean Difference|-13.85||||0.0001|TWO_SIDED|95.0|-20.89|-6.81||Threshold for significance at 0.05 level.|MMRM|||||-6.81|-20.89|0.0001
91766019|NCT03201419|183421354|SUPERIORITY||Mean Difference|-2.84||||0.4355|TWO_SIDED|95.0|-9.99|4.32||Threshold for significance at 0.05 level.|MMRM|||||4.32|-9.99|0.4355
91548660|NCT03241459|182978896|SUPERIORITY|||||||0.797||||||P-value for change in PAQ from BL to 12-Months: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.797
91548661|NCT03241459|182978896|SUPERIORITY|||||||0.29||||||P-value for change in PAQ from BL to 24-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.290
91548662|NCT03241459|182978896|SUPERIORITY|||||||0.473||||||P-value for change in PAQ from BL to 24-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.473
91548663|NCT03241459|182978896|SUPERIORITY|||||||0.278||||||P-value for change in PAQ from BL to 24-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.278
91548664|NCT03241459|182978896|SUPERIORITY|||||||0.974||||||P-value for change in PAQ from BL to 24-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.974
91548665|NCT03241459|182978896|SUPERIORITY|||||||0.266||||||P-value for change in PAQ from BL to 24-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.266
91548666|NCT03241459|182978896|SUPERIORITY|||||||0.656||||||P-value for change in PAQ from BL to 24-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.656
91548667|NCT03241459|182978896|SUPERIORITY|||||||0.959||||||P-value for change in PAQ from BL to 12-Months:Summary Score|Wilcoxon (Mann-Whitney)|||||||0.959
91548668|NCT03241459|182978897|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
91548669|NCT03241459|182978897|SUPERIORITY|||||||0.903||||||P-Value at 48-Months|Fisher Exact|||||||0.903
91548670|NCT03241459|182978897|SUPERIORITY|||||||1||||||P-Value at 60-Months|Fisher Exact|||||||1.0
91548671|NCT03241459|182978898|SUPERIORITY|||||||0.913|||||||Fisher Exact|P-Value at 36-Months||||||0.913
91548672|NCT03241459|182978898|SUPERIORITY|||||||1|||||||Fisher Exact|P-Value at 48-Months||||||1.0
91548673|NCT03241459|182978898|SUPERIORITY|||||||0.839||||||P-Value at 60-Months|Fisher Exact|||||||0.839
91548674|NCT03241459|182978899|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
91548675|NCT03241459|182978899|SUPERIORITY|||||||0.5|||||||Fisher Exact|P-Value at 48-Months||||||0.5
91548676|NCT03241459|182978899|SUPERIORITY|||||||0.251|||||||Fisher Exact|P-Value at 60-Months||||||0.251
91548677|NCT03241459|182978900|SUPERIORITY|||||||0.478||||||P-Value at 36-Months|Fisher Exact|||||||0.478
91548678|NCT03241459|182978900|SUPERIORITY|||||||0.605||||||P-Value at 48-Months|Fisher Exact|||||||0.605
91548679|NCT03241459|182978900|SUPERIORITY|||||||0.345||||||P-Value at 60-Months|Fisher Exact|||||||0.345
91548680|NCT02023866|182978914|OTHER|||||||0.1875|||||||Wilcoxon Signed Rank|||Section I - Current Function Null hypothesis = change from baseline is 0.||||0.1875
91766020|NCT03201419|183421354|SUPERIORITY||Mean Difference|-0.87||||0.8483|TWO_SIDED|95.0|-9.79|8.06||Threshold for significance at 0.05 level.|MMRM|||||8.06|-9.79|0.8483
91766021|NCT03201419|183421354|SUPERIORITY||Mean Difference|-1.61||||0.7336|TWO_SIDED|95.0|-10.91|7.69||Threshold for significance at 0.05 level.|MMRM|||||7.69|-10.91|0.7336
91766022|NCT03201419|183421354|SUPERIORITY||Mean Difference|-0.69||||0.8347|TWO_SIDED|95.0|-7.15|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-7.15|0.8347
91766023|NCT03201419|183421355|SUPERIORITY||Mean Difference|1.59||||0.5695|TWO_SIDED|95.0|-3.9|7.07||Threshold for significance at 0.05 level.|MMRM|||||7.07|-3.90|0.5695
91766024|NCT03201419|183421355|SUPERIORITY||Mean Difference|-3.23||||0.3784|TWO_SIDED|95.0|-10.46|3.99||Threshold for significance at 0.05 level.|MMRM|||||3.99|-10.46|0.3784
91766025|NCT03201419|183421355|SUPERIORITY||Mean Difference|-0.17||||0.9653|TWO_SIDED|95.0|-7.67|7.34||Threshold for significance at 0.05 level.|MMRM|||||7.34|-7.67|0.9653
91766026|NCT03201419|183421355|SUPERIORITY||Mean Difference|2.97||||0.5304|TWO_SIDED|95.0|-6.35|12.29||Threshold for significance at 0.05 level.|MMRM|||||12.29|-6.35|0.5304
91766027|NCT03201419|183421355|SUPERIORITY||Mean Difference|-8.02||||0.0968|TWO_SIDED|95.0|-17.51|1.46||Threshold for significance at 0.05 level.|MMRM|||||1.46|-17.51|0.0968
91766028|NCT03201419|183421355|SUPERIORITY||Mean Difference|0.91||||0.7885|TWO_SIDED|95.0|-5.79|7.62||Threshold for significance at 0.05 level.|MMRM|||||7.62|-5.79|0.7885
91766029|NCT03201419|183421356|SUPERIORITY||Mean Difference|-1.2||||0.6792|TWO_SIDED|95.0|-6.89|4.5||Threshold for significance at 0.05 level.|MMRM|||||4.50|-6.89|0.6792
91766030|NCT03201419|183421356|SUPERIORITY||Mean Difference|-8.39||||0.0276|TWO_SIDED|95.0|-15.84|-0.93||Threshold for significance at 0.05 level.|MMRM|||||-0.93|-15.84|0.0276
91766031|NCT03201419|183421356|SUPERIORITY||Mean Difference|-0.27||||0.9445|TWO_SIDED|95.0|-7.97|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-7.97|0.9445
91766032|NCT03201419|183421356|SUPERIORITY||Mean Difference|2.79||||0.5637|TWO_SIDED|95.0|-6.71|12.28||Threshold for significance at 0.05 level.|MMRM|||||12.28|-6.71|0.5637
91766033|NCT03201419|183421356|SUPERIORITY||Mean Difference|-4.4||||0.387|TWO_SIDED|95.0|-14.39|5.6||Threshold for significance at 0.05 level.|MMRM|||||5.60|-14.39|0.3870
91548681|NCT02023866|182978914|OTHER|||||||1|||||||Wilcoxin Signed Rank|||Section II - System Specific Involvement Null hypothesis = change from baseline is 0.||||1.0000
91548682|NCT02023866|182978914|OTHER|||||||0.0781|||||||Wilcoxin Signed Rank|||Section III - Current Clinical Assessment Null hypothesis = change from baseline is 0.||||0.0781
91548683|NCT02023866|182978914|OTHER|||||||0.2941|||||||t-test, 2 sided|One-sample t-test||Section IV - Quality of Life Null hypothesis = change from baseline is 0.||||0.2941
91548684|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|-0.37||||0.011|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)||||0.011
91548685|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|-0.69||||0.008|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)||||0.008
91548686|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.08||||0.662|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)||||0.662
91548687|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)||||0.41
91548688|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.23||||0.164|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)||||0.164
91548689|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.35||||0.183|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)||||0.183
91548690|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.12||||0.506|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)||||0.506
91548691|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.38||||0.119|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)||||0.119
91548692|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)||||0.510
91548693|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|-0.3||||0.168|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)||||0.168
91548694|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|0.07||||0.454|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)||||0.454
91548695|NCT02432404|182978947|OTHER||Mean Difference (Final Values)|-0.1||||0.471|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)||||0.471
91548696|NCT04114877|182978980|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
91548697|NCT04114877|182978981|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
91548698|NCT04114877|182978982|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
91548699|NCT04114877|182978983|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
91548700|NCT04114877|182978984|SUPERIORITY|||||||0.455|||||||Fisher Exact|||||||0.455
91548701|NCT04709783|182979005|OTHER|One group pre-post test.|Median Difference (Final Values)|-2.67||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.01
91548702|NCT04709783|182979006|OTHER||Median Difference (Final Values)|-2.49||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
91548703|NCT04709783|182979007|OTHER||Median Difference (Final Values)|-1.84||||0.07|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
91548704|NCT04709783|182979008|OTHER||Median Difference (Final Values)|-2.37||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
91548705|NCT06132867|182979027|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90 percent (%) confidence intervals (CIs) were calculated using the exponentiation of the difference between treatment least square means (LSM) from the analyses on the natural log-transformed of Cmax.|Geometric Mean Ratio (GMR) (%)|92.2|||||TWO_SIDED|90.0|86.98|97.74|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||97.74|86.98|
91548706|NCT06132867|182979028|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUClast.|GMR (%)|96.0|||||TWO_SIDED|90.0|88.48|104.16|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||104.16|88.48|
91548707|NCT06132867|182979029|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUCinf.|GMR (%)|95.84|||||TWO_SIDED|90.0|88.81|103.42|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||103.42|88.81|
91548708|NCT04222660|182979031|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91548709|NCT04222660|182979032|OTHER||||||<|0.0025|||||||t-test, 2 sided|||||||<0.0025
91548710|NCT04222660|182979033|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91548711|NCT04222660|182979034|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91548712|NCT04222660|182979035|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91548713|NCT04222660|182979036|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91548714|NCT04222660|182979037|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91548715|NCT04222660|182979038|OTHER||||||<|0.0017|||||||t-test, 2 sided|||||||<0.0017
91548716|NCT04222660|182979039|OTHER||||||<|0.0195|||||||t-test, 2 sided|||||||<0.0195
91548717|NCT04648033|182979055|OTHER||Probability of DLT at dose level 4|0.116|||||TWO_SIDED|95.0|0.032|0.26||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.26|0.032|
91548718|NCT05875142|182979078|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0008|||||||t-test, 1 sided|||T compared with TM||||0.0008
91548719|NCT05875142|182979078|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||5.03e-06|||||||t-test, 1 sided|||T compared with TMC.||||0.00000503
91548720|NCT05875142|182979079|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0176|||||||t-test, 1 sided|||T compared with T||||0.0176
91548721|NCT05875142|182979079|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0056|||||||t-test, 1 sided|||Comparing T with TMC.||||0.0056
91548722|NCT05875142|182979080|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4066|||||||t-test, 1 sided|||T compared with TM||||0.4066
91548723|NCT05875142|182979080|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4045|||||||t-test, 1 sided|||T compared with TMC||||0.4045
91548724|NCT03891667|182979085|SUPERIORITY||Odds Ratio (OR)|4.0|||||TWO_SIDED|95.0|0.21|75.66||||||||75.66|.21|
91548725|NCT03891667|182979086|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.05|9.47||||||||9.47|0.05|
91766034|NCT03201419|183421356|SUPERIORITY||Mean Difference|0.72||||0.8373|TWO_SIDED|95.0|-6.19|7.63||Threshold for significance at 0.05 level.|MMRM|||||7.63|-6.19|0.8373
91548726|NCT02100813|182979128|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.42|0.23|<0.001
91548727|NCT02100813|182979128|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.33|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.33|0.18|<0.001
91548728|NCT02100813|182979128|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79|||=|0.096|TWO_SIDED|95.0|0.59|1.04|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||1.04|0.59|=0.096
91548729|NCT02100813|182979129|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|7.02|||=|0.007|TWO_SIDED|95.0|1.53|124.0|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||124|1.53|=0.007
91548730|NCT02100813|182979129|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.82|||=|0.001|TWO_SIDED|95.0|1.99|154.5|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||154.5|1.99|=0.001
91548731|NCT02100813|182979129|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.26|||=|0.43|TWO_SIDED|95.0|0.72|2.31|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.31|0.72|=0.43
91548732|NCT02100813|182979130|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.73|||<|0.001|TWO_SIDED|95.0|2.93|51.66|||Log binomial regression|||||51.66|2.93|<0.001
91548733|NCT02100813|182979130|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|9.55|||<|0.001|TWO_SIDED|95.0|3.22|56.4|||Log binomial regression|||||56.4|3.22|<0.001
91548734|NCT02100813|182979130|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.09|||=|0.55|TWO_SIDED|95.0|0.81|1.49|||Log binomial regression|||||1.49|0.81|=0.55
91548735|NCT01963793|182979131|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.58|TWO_SIDED|95.0|-7.12|4.11|||t-test, 2 sided|||||4.11|-7.12|0.58
91548736|NCT04749615|182979263|NON_INFERIORITY|Noninferiority Margin = (-Infinity, 1.28)||||||0.11|||||||t-test, 1 sided|||||||0.11
91548737|NCT04749615|182979264|NON_INFERIORITY|a noninferiority margin of 1.0 and 10% attrition|Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0||||this is the calculated p-value.|t-test, 2 sided|||||||0.5
91548738|NCT05746494|182979330|OTHER|Omnibus analysis||||||0.023|||||||ANOVA|||||||0.023
91548739|NCT05746494|182979331|OTHER|Omnibus analysis||||||0.042|||||||Multilevel Modeling|||||||0.042
91548740|NCT05746494|182979332|OTHER|Omnibus analysis||||||0.98|||||||t-test, 2 sided|||||||0.980
91548741|NCT05746494|182979333|OTHER|Omnibus analysis||||||0.01|||||||Multilevel Modeling|||||||0.010
91766035|NCT03201419|183421357|SUPERIORITY||Mean Difference|0.53||||0.8646|TWO_SIDED|95.0|-5.54|6.59||Threshold for significance at 0.05 level.|MMRM|||||6.59|-5.54|0.8646
91766036|NCT03201419|183421357|SUPERIORITY||Mean Difference|-6.99||||0.087|TWO_SIDED|95.0|-15.0|1.02||Threshold for significance at 0.05 level.|MMRM|||||1.02|-15.00|0.0870
91766037|NCT03201419|183421357|SUPERIORITY||Mean Difference|2.77||||0.51|TWO_SIDED|95.0|-5.5|11.04||Threshold for significance at 0.05 level.|MMRM|||||11.04|-5.50|0.5100
91766038|NCT03201419|183421357|SUPERIORITY||Mean Difference|7.32||||0.1535|TWO_SIDED|95.0|-2.75|17.39||Threshold for significance at 0.05 level.|MMRM|||||17.39|-2.75|0.1535
91766039|NCT03201419|183421357|SUPERIORITY||Mean Difference|-5.14||||0.3369|TWO_SIDED|95.0|-15.66|5.38||Threshold for significance at 0.05 level.|MMRM|||||5.38|-15.66|0.3369
91548742|NCT05746494|182979334|OTHER|Omnibus analysis||||||0.064|||||||t-test, 2 sided|||||||0.064
91548743|NCT05746494|182979335|OTHER|Omnibus analysis||||||0.306|||||||t-test, 2 sided|||||||0.306
91548744|NCT05746494|182979336|OTHER|Omnibus analysis||||||0.041|||||||t-test, 2 sided|||||||0.041
91548745|NCT05746494|182979337|OTHER|Omnibus analysis||||||0.019|||||||t-test, 2 sided|||||||0.019
91548746|NCT04806451|182979350|SUPERIORITY||LS Mean Difference|-267.775|STANDARD_ERROR_OF_MEAN|68.313||0.0002|TWO_SIDED|95.0|-403.427|-132.124|||ANCOVA|||||-132.124|-403.427|0.0002
91548747|NCT05894577|182979357|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
91548748|NCT05894577|182979358|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.14|7.07|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||7.07|0.14|
91766040|NCT03201419|183421357|SUPERIORITY||Mean Difference|0.27||||0.9417|TWO_SIDED|95.0|-7.05|7.59||Threshold for significance at 0.05 level.|MMRM|||||7.59|-7.05|0.9417
91766041|NCT03201419|183421358|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-1.41|5.47||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||5.47|-1.41|
91548749|NCT05894577|182979361|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.45|1.84|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.84|0.45|
91548750|NCT05894577|182979362|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.5|2.29|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.29|0.50|
91548751|NCT05894577|182979363|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.16|1.49|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.49|0.16|
91548752|NCT05894577|182979364|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.33|2.96|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.96|0.33|
91548753|NCT05894577|182979365|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.71|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.71|
91548754|NCT05894577|182979365|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.75|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|0.75|
91548755|NCT05894577|182979365|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.88|0.84|
91548756|NCT05894577|182979365|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.65|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.60|0.65|
91548757|NCT05894577|182979365|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.57|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.36|0.57|
91548758|NCT05894577|182979365|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.69|2.0|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||2.00|0.69|
91548759|NCT05894577|182979366|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.15|0.66|
91548760|NCT05894577|182979366|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.14|0.63|
91548761|NCT05894577|182979366|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.56|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.56|
91766042|NCT03201419|183421358|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.43|1.19||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.19|-0.43|
91766043|NCT03201419|183421358|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.16|0.5||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.50|-0.16|
91766044|NCT03201419|183421358|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.03|0.15||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.15|-0.03|
91766045|NCT03201419|183421358|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.01|0.05||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.05|-0.01|
91766046|NCT03201419|183421358|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.01|-0.00|
91548762|NCT05894577|182979366|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.73|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.45|0.73|
91548763|NCT05894577|182979366|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.71|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.40|0.71|
91548764|NCT05894577|182979366|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.60|
91548765|NCT05894577|182979367|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.7|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.70|
91548766|NCT05894577|182979367|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.72|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.40|0.72|
91766047|NCT03201419|183421359|SUPERIORITY||Mean Difference|5.2||||0.3328|TWO_SIDED|95.0|-5.3|15.7||Threshold for significance at 0.05 level.|ANCOVA|||||15.7|-5.3|0.3328
91766048|NCT03201419|183421359|SUPERIORITY||Mean Difference|15.5||||0.0255|TWO_SIDED|95.0|1.9|29.2||Threshold for significance at 0.05 level.|ANCOVA|||||29.2|1.9|0.0255
91766049|NCT03201419|183421359|SUPERIORITY||Mean Difference|2.5||||0.7296|TWO_SIDED|95.0|-11.7|16.7||Threshold for significance at 0.05 level.|ANCOVA|||||16.7|-11.7|0.7296
91766050|NCT03201419|183421359|SUPERIORITY||Mean Difference|-6.7||||0.4586|TWO_SIDED|95.0|-24.5|11.1||Threshold for significance at 0.05 level.|ANCOVA|||||11.1|-24.5|0.4586
91766051|NCT03201419|183421359|SUPERIORITY||Mean Difference|11.2||||0.2327|TWO_SIDED|95.0|-7.2|29.5||Threshold for significance at 0.05 level.|ANCOVA|||||29.5|-7.2|0.2327
91548767|NCT05894577|182979367|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.55|
91548768|NCT05894577|182979367|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.62|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.39|0.62|
91548769|NCT05894577|182979367|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.65|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.65|
91548770|NCT05894577|182979367|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.48|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.48|
91548771|NCT05894577|182979368|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.62|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.62|
91766052|NCT03201419|183421359|SUPERIORITY||Mean Difference|-0.6||||0.924|TWO_SIDED|95.0|-13.3|12.1||Threshold for significance at 0.05 level.|ANCOVA|||||12.1|-13.3|0.9240
91766053|NCT03201419|183421360|SUPERIORITY||Mean Difference|0.3||||0.9499|TWO_SIDED|95.0|-7.9|8.5||Threshold for significance at 0.05 level.|ANCOVA|||||8.5|-7.9|0.9499
91766054|NCT03201419|183421360|SUPERIORITY||Mean Difference|5.8||||0.2842|TWO_SIDED|95.0|-4.8|16.4||Threshold for significance at 0.05 level.|ANCOVA|||||16.4|-4.8|0.2842
91766055|NCT03201419|183421360|SUPERIORITY||Mean Difference|-5.7||||0.31|TWO_SIDED|95.0|-16.8|5.4||Threshold for significance at 0.05 level.|ANCOVA|||||5.4|-16.8|0.3100
91548772|NCT05894577|182979368|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.38|0.65|
91548773|NCT05894577|182979368|OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.13|0.49|
91766056|NCT03201419|183421360|SUPERIORITY||Mean Difference|-10.1||||0.1499|TWO_SIDED|95.0|-23.9|3.7||Threshold for significance at 0.05 level.|ANCOVA|||||3.7|-23.9|0.1499
91766057|NCT03201419|183421360|SUPERIORITY||Mean Difference|-8.2||||0.2571|TWO_SIDED|95.0|-22.5|6.0||Threshold for significance at 0.05 level.|ANCOVA|||||6.0|-22.5|0.2571
91766058|NCT03201419|183421360|SUPERIORITY||Mean Difference|-1.5||||0.7629|TWO_SIDED|95.0|-11.4|8.3||Threshold for significance at 0.05 level.|ANCOVA|||||8.3|-11.4|0.7629
91766059|NCT03201419|183421361|SUPERIORITY||Mean Difference|2.48||||0.4846|TWO_SIDED|95.0|-4.5|9.46||Threshold for significance at 0.05 level.|MMRM|||||9.46|-4.50|0.4846
91766060|NCT03201419|183421361|SUPERIORITY||Mean Difference|-16.93||||0.0004|TWO_SIDED|95.0|-26.26|-7.6||Threshold for significance at 0.05 level.|MMRM|||||-7.60|-26.26|0.0004
91766061|NCT03201419|183421361|SUPERIORITY||Mean Difference|-2.05||||0.6685|TWO_SIDED|95.0|-11.47|7.37||Threshold for significance at 0.05 level.|MMRM|||||7.37|-11.47|0.6685
91766062|NCT03201419|183421361|SUPERIORITY||Mean Difference|1.69||||0.7772|TWO_SIDED|95.0|-10.07|13.46||Threshold for significance at 0.05 level.|MMRM|||||13.46|-10.07|0.7772
91766063|NCT03201419|183421361|SUPERIORITY||Mean Difference|10.67||||0.0895|TWO_SIDED|95.0|-1.66|23.0||Threshold for significance at 0.05 level.|MMRM|||||23.00|-1.66|0.0895
91766064|NCT03201419|183421361|SUPERIORITY||Mean Difference|1.2||||0.782|TWO_SIDED|95.0|-7.34|9.74|||MMRM|||||9.74|-7.34|0.7820
91548774|NCT05894577|182979368|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.67|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.55|0.67|
91548775|NCT05894577|182979368|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.19|0.51|
91548776|NCT05894577|182979368|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.49|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.49|
91548777|NCT05894577|182979369|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.41|0.77|
91548778|NCT05894577|182979369|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.82|1.69|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.69|0.82|
91548779|NCT05894577|182979369|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.52|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.52|
91766065|NCT03201419|183421362|SUPERIORITY||Mean Difference|-0.41||||0.9175|TWO_SIDED|95.0|-8.25|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-8.25|0.9175
91766066|NCT03201419|183421362|SUPERIORITY||Mean Difference|-4.32||||0.4098|TWO_SIDED|95.0|-14.62|5.98||Threshold for significance at 0.05 level.|MMRM|||||5.98|-14.62|0.4098
91548780|NCT05894577|182979369|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.65|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.43|0.65|
91548781|NCT05894577|182979369|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.41|0.63|
91548782|NCT05894577|182979369|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.44|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.19|0.44|
91548783|NCT05894577|182979370|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.39|0.75|
91548784|NCT05894577|182979370|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.76|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.44|0.76|
91548785|NCT05894577|182979370|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.84|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.71|0.84|
91548786|NCT05894577|182979370|OTHER||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.76|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.71|0.76|
91548787|NCT05894577|182979370|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.67|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.67|
91548788|NCT05894577|182979370|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.59|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.59|0.62|
91766067|NCT03201419|183421362|SUPERIORITY||Mean Difference|2.41||||0.6566|TWO_SIDED|95.0|-8.25|13.06||Threshold for significance at 0.05 level.|MMRM|||||13.06|-8.25|0.6566
91766068|NCT03201419|183421362|SUPERIORITY||Mean Difference|3.39||||0.6144|TWO_SIDED|95.0|-9.85|16.63||Threshold for significance at 0.05 level.|MMRM|||||16.63|-9.85|0.6144
91548789|NCT05894577|182979371|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.74|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.14|0.74|
91548790|NCT05894577|182979371|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.79|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.22|0.79|
91766069|NCT03201419|183421362|SUPERIORITY||Mean Difference|3.8||||0.5798|TWO_SIDED|95.0|-9.71|17.31||Threshold for significance at 0.05 level.|MMRM|||||17.31|-9.71|0.5798
91766070|NCT03201419|183421362|SUPERIORITY||Mean Difference|0.35||||0.9417|TWO_SIDED|95.0|-9.17|9.88||Threshold for significance at 0.05 level.|MMRM|||||9.88|-9.17|0.9417
91766071|NCT03201419|183421363|SUPERIORITY||Mean Difference|-2.81||||0.5148|TWO_SIDED|95.0|-11.31|5.68||Threshold for significance at 0.05 level.|MMRM|||||5.68|-11.31|0.5148
91766072|NCT03201419|183421363|SUPERIORITY||Mean Difference|-9.65||||0.0879|TWO_SIDED|95.0|-20.75|1.44||Threshold for significance at 0.05 level.|MMRM|||||1.44|-20.75|0.0879
91548791|NCT05894577|182979371|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.71|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.71|
91548792|NCT05894577|182979371|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.80|
91548793|NCT05894577|182979371|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.29|0.84|
91548794|NCT05894577|182979371|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.68|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.14|0.68|
91548795|NCT05894577|182979372|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.24|||||TWO_SIDED|95.0|-0.6|0.1|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.1|-0.6|
91766073|NCT03201419|183421363|SUPERIORITY||Mean Difference|3.61||||0.5335|TWO_SIDED|95.0|-7.79|15.0||Threshold for significance at 0.05 level.|MMRM|||||15.00|-7.79|0.5335
91766074|NCT03201419|183421363|SUPERIORITY||Mean Difference|6.29||||0.3787|TWO_SIDED|95.0|-7.76|20.34||Threshold for significance at 0.05 level.|MMRM|||||20.34|-7.76|0.3787
91766075|NCT03201419|183421363|SUPERIORITY||Mean Difference|1.48||||0.8448|TWO_SIDED|95.0|-13.41|16.38||Threshold for significance at 0.05 level.|MMRM|||||16.38|-13.41|0.8448
91766076|NCT03201419|183421363|SUPERIORITY||Mean Difference|4.62||||0.3751|TWO_SIDED|95.0|-5.63|14.87||Threshold for significance at 0.05 level.|MMRM|||||14.87|-5.63|0.3751
91766077|NCT03201419|183421364|SUPERIORITY||Mean Difference|-0.43||||0.9245|TWO_SIDED|95.0|-9.43|8.57||Threshold for significance at 0.05 level.|MMRM|||||8.57|-9.43|0.9245
91766078|NCT03201419|183421364|SUPERIORITY||Mean Difference|-6.72||||0.2657|TWO_SIDED|95.0|-18.59|5.15||Threshold for significance at 0.05 level.|MMRM|||||5.15|-18.59|0.2657
91548796|NCT05894577|182979373|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.31|||||TWO_SIDED|95.0|-0.13|0.75|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.75|-0.13|
91548797|NCT03134196|182979432|SUPERIORITY||Hazard Ratio (HR)|0.78|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.5|1.06||||||||1.06|0.5|
91548798|NCT03134196|182979433|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.04|||TWO_SIDED|95.0|0.56|0.99||||||||0.99|0.56|
91548799|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548800|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548801|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91766079|NCT03201419|183421364|SUPERIORITY||Mean Difference|9.2||||0.1383|TWO_SIDED|95.0|-2.99|21.38||Threshold for significance at 0.05 level.|MMRM|||||21.38|-2.99|0.1383
91548802|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91766080|NCT03201419|183421364|SUPERIORITY||Mean Difference|14.72||||0.0523|TWO_SIDED|95.0|-0.15|29.59||Threshold for significance at 0.05 level.|MMRM|||||29.59|-0.15|0.0523
91548803|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548804|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548805|NCT00875277|182979438|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
91548806|NCT00875277|182979438|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
91548807|NCT00875277|182979438|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
91548808|NCT00875277|182979438|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
91548809|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548810|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548811|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548812|NCT00875277|182979438|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91548813|NCT00875277|182979438|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
91548814|NCT04541147|182979454|EQUIVALENCE|Test if the number of doses in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|6.9|STANDARD_DEVIATION|10.1||0.16|TWO_SIDED|95.0|-2.9|16.7|||t-test, 2 sided|||||16.7|-2.9|0.16
91548815|NCT04541147|182979455|EQUIVALENCE|Test if the average pain score in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|1.4||0.56|TWO_SIDED|95.0|-1.8|1.0|||t-test, 2 sided|||||1.0|-1.8|0.56
91548816|NCT04541147|182979456|EQUIVALENCE|Test if the Number of participants with post-operative complications in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.15||1|TWO_SIDED|95.0|-0.22|0.36|||Fisher Exact|||||0.36|-0.22|1.00
91766081|NCT03201419|183421364|SUPERIORITY||Mean Difference|1.14||||0.8855|TWO_SIDED|95.0|-14.47|16.75||Threshold for significance at 0.05 level.|MMRM|||||16.75|-14.47|0.8855
91766082|NCT03201419|183421364|SUPERIORITY||Mean Difference|2.91||||0.5972|TWO_SIDED|95.0|-7.91|13.72||Threshold for significance at 0.05 level.|MMRM|||||13.72|-7.91|0.5972
91766083|NCT03201419|183421365|SUPERIORITY||Mean Difference|-0.54|||||TWO_SIDED|95.0|-6.09|2.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.28|-6.09|
91766084|NCT03201419|183421365|SUPERIORITY||Mean Difference|-0.28|||||TWO_SIDED|95.0|-4.3|0.75||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.75|-4.30|
91766085|NCT03201419|183421365|SUPERIORITY||Mean Difference|-0.15|||||TWO_SIDED|95.0|-2.44|0.33||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.33|-2.44|
91766086|NCT03201419|183421365|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.92|0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.07|-0.92|
91548817|NCT04064164|182979479|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.004||||||Dear (root word)|Chi-squared|X-squared = 8.4 df=1||||||.004
91548818|NCT04064164|182979479|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App. Significant associations indicated the human and app were accurately identifying true positives (1:1) or true negatives (0:0).|||||<|0.001||||||Sweet (root word)|Chi-squared|X-squared = 20.20 df=1||||||<.001
91548819|NCT04064164|182979479|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.02||||||Girl (root word)|Chi-squared|X-squared = 5.08, df=1||||||.02
91548820|NCT04064164|182979479|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.1||||||Honey (root word)|Chi-squared|X-squared = 2.7, df= 1||||||.10
91548821|NCT04064164|182979479|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.85||||||Baby (root word)|Chi-squared|X-squared = 12.2, df = 1||||||0.85
91766087|NCT03201419|183421365|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.48|0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.02|-0.48|
91766088|NCT03201419|183421365|SUPERIORITY||Mean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.00|-0.15|
91766089|NCT03201419|183421366|SUPERIORITY||Mean Difference|-0.27||||0.055|TWO_SIDED|95.0|-0.545|0.006||Threshold for significance at 0.05 level.|MMRM|||||0.006|-0.545|0.0550
91766090|NCT03201419|183421366|SUPERIORITY||Mean Difference|-0.7||||0.0002|TWO_SIDED|95.0|-1.066|-0.335||Threshold for significance at 0.05 level.|MMRM|||||-0.335|-1.066|0.0002
91548822|NCT04026555|182979537|SUPERIORITY||Risk Ratio (RR)|1.43|||<|0.001|TWO_SIDED|95.0|1.16|1.78|||Regression, Poisson|||IPTW Poisson regression was used to model the number of escalations per visit with an offset of the log transformed length of stay normalized per 1000 bed days. Treatment effect is expressed in terms of adjusted incidence rate ratio (IRR) per 1000 patient bed days.||1.78|1.16|< 0.001
91548823|NCT04026555|182979538|SUPERIORITY||Risk Ratio (RR)|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regres- sion models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||2.18|1.39|<0.001
91548824|NCT04026555|182979541|SUPERIORITY||Risk Ratio (RR)|0.76||||0.045|TWO_SIDED|95.0|0.58|0.99||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regression models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||0.99|0.58|0.045
91548825|NCT04026555|182979546|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.14|TWO_SIDED|95.0|0.98|1.18|||Regression, Cox|||||1.18|0.98|0.14
91548826|NCT04295798|182979566|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to gait speed from baseline to immediately post intervention.||||0.02
91548827|NCT04295798|182979567|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway speed from baseline to immediately post intervention.||||0.02
91548828|NCT04295798|182979568|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.04|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to stride time variability from baseline to immediately post intervention.||||0.04
91548829|NCT04295798|182979569|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.56|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task gait speed from baseline to immediately post intervention.||||0.56
91766091|NCT03201419|183421366|SUPERIORITY||Mean Difference|-0.037||||0.844|TWO_SIDED|95.0|-0.404|0.33||Threshold for significance at 0.05 level.|MMRM|||||0.330|-0.404|0.8440
91766092|NCT03201419|183421366|SUPERIORITY||Mean Difference|0.041||||0.861|TWO_SIDED|95.0|-0.417|0.498||Threshold for significance at 0.05 level.|MMRM|||||0.498|-0.417|0.8610
91766093|NCT03201419|183421366|SUPERIORITY||Mean Difference|0.036||||0.8871|TWO_SIDED|95.0|-0.46|0.532||Threshold for significance at 0.05 level.|MMRM|||||0.532|-0.460|0.8871
91766094|NCT03201419|183421366|SUPERIORITY||Mean Difference|0.013||||0.9396|TWO_SIDED|95.0|-0.313|0.338||Threshold for significance at 0.05 level.|MMRM|||||0.338|-0.313|0.9396
91766095|NCT03201419|183421367|SUPERIORITY||Mean Difference|-0.475||||0.005|TWO_SIDED|95.0|-0.806|-0.145||Threshold for significance at 0.05 level.|MMRM|||||-0.145|-0.806|0.0050
91766096|NCT03201419|183421367|SUPERIORITY||Mean Difference|-0.405||||0.0665|TWO_SIDED|95.0|-0.837|0.028||Threshold for significance at 0.05 level.|MMRM|||||0.028|-0.837|0.0665
91766097|NCT03201419|183421367|SUPERIORITY||Mean Difference|-0.149||||0.5245|TWO_SIDED|95.0|-0.608|0.31||Threshold for significance at 0.05 level.|MMRM|||||0.310|-0.608|0.5245
91766098|NCT03201419|183421367|SUPERIORITY||Mean Difference|-0.075||||0.7947|TWO_SIDED|95.0|-0.642|0.492||Threshold for significance at 0.05 level.|MMRM|||||0.492|-0.642|0.7947
91548830|NCT04295798|182979570|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.07|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task gait speed from baseline to immediately post intervention.||||0.07
91548831|NCT04295798|182979571|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.74|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task stride time variability from baseline to immediately post intervention.||||0.74
91548832|NCT04295798|182979572|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.33|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task stride time variability from baseline to immediately post intervention.||||0.33
91548833|NCT04295798|182979573|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.16|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway area from baseline to immediately post intervention.||||0.16
91548834|NCT04295798|182979574|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.52|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway speed from baseline to immediately post intervention.||||0.52
91548835|NCT04295798|182979575|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.01|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway speed from baseline to immediately post intervention.||||0.01
91766099|NCT03201419|183421367|SUPERIORITY||Mean Difference|-0.211||||0.4625|TWO_SIDED|95.0|-0.777|0.355||Threshold for significance at 0.05 level.|MMRM|||||0.355|-0.777|0.4625
91766100|NCT03201419|183421367|SUPERIORITY||Mean Difference|-0.014||||0.9465|TWO_SIDED|95.0|-0.412|0.385||Threshold for significance at 0.05 level.|MMRM|||||0.385|-0.412|0.9465
91548836|NCT04295798|182979576|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.39|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway area from baseline to immediately post intervention||||0.39
91548837|NCT04295798|182979577|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.18|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway area from baseline to immediately post intervention.||||0.18
91548838|NCT06429319|182979578|SUPERIORITY||F value|5.919||||0.004|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||No sample size calculation was performed. Maximum expected number of participants for OLE was 72 patients randomized to the NOLTREX™ group in the parent study (IA/PAAG-SI/OA/2019). A total of 65 patients entered the OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.004
91766101|NCT03201419|183421368|SUPERIORITY||Mean Difference|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.078|-0.383||Threshold for significance at 0.05 level.|MMRM|||||-0.383|-1.078|<0.0001
91766102|NCT03201419|183421368|SUPERIORITY||Mean Difference|-0.686||||0.003|TWO_SIDED|95.0|-1.137|-0.236||Threshold for significance at 0.05 level.|MMRM|||||-0.236|-1.137|0.0030
91766103|NCT03201419|183421368|SUPERIORITY||Mean Difference|-0.045||||0.852|TWO_SIDED|95.0|-0.517|0.427||Threshold for significance at 0.05 level.|MMRM|||||0.427|-0.517|0.8520
91766104|NCT03201419|183421368|SUPERIORITY||Mean Difference|-0.287||||0.3205|TWO_SIDED|95.0|-0.856|0.281||Threshold for significance at 0.05 level.|MMRM|||||0.281|-0.856|0.3205
91766105|NCT03201419|183421368|SUPERIORITY||Mean Difference|-0.418||||0.1769|TWO_SIDED|95.0|-1.026|0.19||Threshold for significance at 0.05 level.|MMRM|||||0.190|-1.026|0.1769
91548839|NCT06429319|182979578|SUPERIORITY||LS-means difference|-37.64|STANDARD_ERROR_OF_MEAN|56.34||0.783|TWO_SIDED|95.0|-172.98|97.7||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||97.70|-172.98|0.783
91548840|NCT06429319|182979578|SUPERIORITY||LS-means difference|81.94|STANDARD_ERROR_OF_MEAN|60.45||0.37|TWO_SIDED|95.0|-63.28|227.16|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||227.16|-63.28|0.370
91548841|NCT06429319|182979578|SUPERIORITY||LS-means difference|119.58|STANDARD_ERROR_OF_MEAN|34.76||0.003|TWO_SIDED|95.0|36.09|203.07||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||203.07|36.09|0.003
91548842|NCT06429319|182979578|SUPERIORITY||F value|2.78||||0.07|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||The between-group comparison of changes from baseline (visit 1 study 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.070
91548843|NCT06429319|182979582|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (study 1 visit 1)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.030
91548844|NCT06429319|182979582|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (OLE visit 0)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.002
91548845|NCT06429319|182979582|SUPERIORITY|||||||0.007||||||The threshold for statistical significance was p \<0.05.|ANOVA|||"visit 3~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.007
91766106|NCT03201419|183421368|SUPERIORITY||Mean Difference|-0.3||||0.1584|TWO_SIDED|95.0|-0.717|0.118||Threshold for significance at 0.05 level.|MMRM|||||0.118|-0.717|0.1584
91766107|NCT03201419|183421369|SUPERIORITY||Mean Difference|-0.822|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.424||Threshold for significance at 0.05 level.|MMRM|||||-0.424|-1.220|<0.0001
91548846|NCT06429319|182979582|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"visit 5~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||<0.001
91548847|NCT06429319|182979583|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"Fisher's exact test was used to determine whether there is a significant difference between 3 groups.~visit 3"||||<0.001
91548848|NCT06429319|182979583|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there is a significant difference between 3 groups."||||<0.001
91548849|NCT06429319|182979584|SUPERIORITY|||||||0.018||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 3~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||0.018
91548850|NCT06429319|182979584|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||<0.001
91548851|NCT06429319|182979587|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution.||||0.010
91548852|NCT05364671|182979603|SUPERIORITY|||||||0.0088||||||A priori threshold for statistical significance is set to 0.04|Chi-squared|||||||0.0088
91548853|NCT05364671|182979604|SUPERIORITY|||||||0.0025||||||A priori threshold for statistical significance is set to 0.005|Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.0025
91548854|NCT05364671|182979606|SUPERIORITY|||||||0.2607|||||||Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.2607
91548855|NCT05364671|182979607|SUPERIORITY|||||||0.7601|||||||Fisher Exact|||"This analysis applies to Day 6 row."||||0.7601
91548856|NCT05364671|182979607|SUPERIORITY|||||||0.7685|||||||Fisher Exact|||"This analysis applies to Day 10 row."||||0.7685
91548857|NCT05364671|182979608|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
91548858|NCT05364671|182979609|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
91548859|NCT05364671|182979610|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
91548860|NCT05364671|182979611|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
91548861|NCT05364671|182979612|SUPERIORITY|||||||0.92||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.92
91548862|NCT05364671|182979613|SUPERIORITY|||||||0.44||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.44
91766108|NCT03201419|183421369|SUPERIORITY||Mean Difference|-0.818||||0.0019|TWO_SIDED|95.0|-1.331|-0.306||Threshold for significance at 0.05 level.|MMRM|||||-0.306|-1.331|0.0019
91766109|NCT03201419|183421369|SUPERIORITY||Mean Difference|0.167||||0.551|TWO_SIDED|95.0|-0.383|0.716||Threshold for significance at 0.05 level.|MMRM|||||0.716|-0.383|0.5510
91766110|NCT03201419|183421369|SUPERIORITY||Mean Difference|-0.038||||0.9086|TWO_SIDED|95.0|-0.685|0.61||Threshold for significance at 0.05 level.|MMRM|||||0.610|-0.685|0.9086
91766111|NCT03201419|183421369|SUPERIORITY||Mean Difference|-0.812||||0.0185|TWO_SIDED|95.0|-1.486|-0.138||Threshold for significance at 0.05 level.|MMRM|||||-0.138|-1.486|0.0185
91548863|NCT05364671|182979614|SUPERIORITY|||||||0.9||||||"The p-value associated with treatment\*visit interaction of SpO2 from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.90
91548864|NCT05364671|182979615|SUPERIORITY|||||||0.3||||||"The p-value associated with treatment\*visit interaction of SBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.30
91548865|NCT05364671|182979615|SUPERIORITY|||||||0.94||||||"The p-value associated with treatment\*visit interaction of DBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.94
91548866|NCT05794243|182979620|OTHER||Ratio of Geometric Least Squares Means|0.13|||||TWO_SIDED|90.0|0.0741|0.228|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The least square means (LSMs) and differences in LSMs were back transformed to produce the ratio between geometric least square means (GLSMs).||0.228|0.0741|
91548867|NCT05794243|182979620|OTHER||Ratio of Geometric Least Squares Means|0.399|||||TWO_SIDED|90.0|0.237|0.669|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.669|0.237|
91766112|NCT03201419|183421369|SUPERIORITY||Mean Difference|-0.106||||0.6537|TWO_SIDED|95.0|-0.569|0.357||Threshold for significance at 0.05 level.|MMRM|||||0.357|-0.569|0.6537
91766113|NCT03201419|183421370|SUPERIORITY||Least Square Mean Difference|-0.146||||0.235|TWO_SIDED|95.0|-0.388|0.096||Threshold for significance at 0.05 level.|MMRM|||||0.096|-0.388|0.2350
91548868|NCT05794243|182979622|OTHER||Ratio of Geometric Least Squares Means|0.106|||||TWO_SIDED|90.0|0.062|0.182|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.182|0.0620|
91548869|NCT05794243|182979622|OTHER||Ratio of Geometric Least Squares Means|0.343|||||TWO_SIDED|90.0|0.206|0.569|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.569|0.206|
91548870|NCT03637660|182979628|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.002|TWO_SIDED|90.0|-0.15|0.03||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|To assess the primary efficacy endpoint, the number and proportion of participants with a serological response by Month 6 and the 95% confidence interval were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis for the primary objective was that the difference in proportion of participants with serological responses between the three-dose and one-dose groups was at least 10%||0.03|-0.15|0.002
91548871|NCT03637660|182979636|EQUIVALENCE|The alternative hypothesis was that the two treatment groups were unequal.|||||<|0.001||||||P-value was calculated based on 2-sided Pearson Chi-Square test. Difference in proportion was reported with the Wilson 95% CI|Chi-squared|||The number and proportion of participants who were compliant to the treatment, receiving all assigned doses within the assigned visit windows. The null hypothesis was no difference between two treatment groups.||||< 0.001
91766114|NCT03201419|183421370|SUPERIORITY||Least Square Mean Difference|-0.377||||0.0215|TWO_SIDED|95.0|-0.699|-0.056||Threshold for significance at 0.05 level.|MMRM|||||-0.056|-0.699|0.0215
91766115|NCT03201419|183421370|SUPERIORITY||Least Square Mean Difference|-0.218||||0.1818|TWO_SIDED|95.0|-0.54|0.103||Threshold for significance at 0.05 level.|MMRM|||||0.103|-0.540|0.1818
91766116|NCT03201419|183421370|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8063|TWO_SIDED|95.0|-0.45|0.35||Threshold for significance at 0.05 level.|MMRM|||||0.350|-0.450|0.8063
91766117|NCT03201419|183421370|SUPERIORITY||Least Square Mean Difference|0.176||||0.4414|TWO_SIDED|95.0|-0.274|0.627||Threshold for significance at 0.05 level.|MMRM|||||0.627|-0.274|0.4414
91766118|NCT03201419|183421370|SUPERIORITY||Least Square Mean Difference|-0.126||||0.4179|TWO_SIDED|95.0|-0.432|0.18||Threshold for significance at 0.05 level.|MMRM|||||0.180|-0.432|0.4179
91766119|NCT03201419|183421371|SUPERIORITY||Least Square Mean Difference|0.061||||0.6042|TWO_SIDED|95.0|-0.17|0.292||Threshold for significance at 0.05 level.|MMRM|||||0.292|-0.170|0.6042
91548872|NCT03637660|182979638|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.022|TWO_SIDED|90.0|-0.17|0.07||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.07|-0.17|0.022
91548873|NCT03637660|182979638|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.037|TWO_SIDED|90.0|-0.22|0.09||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.09|-0.22|0.037
91548874|NCT03637660|182979639|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.002|TWO_SIDED|90.0|-0.14|0.04||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by Month 12 and the 95% confidence interval (CI) were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.04|-0.14|0.002
91548875|NCT03637660|182979640|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.011|TWO_SIDED|90.0|-0.18|0.05||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-infected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.05|-0.18|0.011
91548876|NCT03637660|182979640|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.03||||0.064|TWO_SIDED|90.0|-0.18|0.11||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 amont participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.11|-0.18|0.064
91548877|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.0|-1.0|
91766120|NCT03201419|183421371|SUPERIORITY||Least Square Mean Difference|-0.127||||0.4114|TWO_SIDED|95.0|-0.432|0.177||Threshold for significance at 0.05 level.|MMRM|||||0.177|-0.432|0.4114
91766121|NCT03201419|183421371|SUPERIORITY||Least Square Mean Difference|0.099||||0.5394|TWO_SIDED|95.0|-0.219|0.418||Threshold for significance at 0.05 level.|MMRM|||||0.418|-0.219|0.5394
91766122|NCT03201419|183421371|SUPERIORITY||Least Square Mean Difference|0.149||||0.459|TWO_SIDED|95.0|-0.246|0.544||Threshold for significance at 0.05 level.|MMRM|||||0.544|-0.246|0.4590
91766123|NCT03201419|183421371|SUPERIORITY||Least Square Mean Difference|0.242||||0.2397|TWO_SIDED|95.0|-0.163|0.647||Threshold for significance at 0.05 level.|MMRM|||||0.647|-0.163|0.2397
91766124|NCT03201419|183421371|SUPERIORITY||Least Square Mean Difference|-0.039||||0.7954|TWO_SIDED|95.0|-0.332|0.254||Threshold for significance at 0.05 level.|MMRM|||||0.254|-0.332|0.7954
91548878|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.8|||||TWO_SIDED|95.0|-0.6|3.7||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.7|-0.6|
91548879|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.3|1.9||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||1.9|-2.3|
91548880|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.8|||||TWO_SIDED|95.0|-3.3|2.5||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.5|-3.3|
91548881|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-6.3|0.8||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||0.8|-6.3|
91548882|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.3|||||TWO_SIDED|95.0|-1.8|3.5||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.5|-1.8|
91766125|NCT03201419|183421372|SUPERIORITY||Least Square Mean Difference|-0.332||||0.0077|TWO_SIDED|95.0|-0.576|-0.089||Threshold for significance at 0.05 level.|MMRM|||||-0.089|-0.576|0.0077
91766126|NCT03201419|183421372|SUPERIORITY||Least Square Mean Difference|-0.61||||0.0002|TWO_SIDED|95.0|-0.927|-0.293||Threshold for significance at 0.05 level.|MMRM|||||-0.293|-0.927|0.0002
91766127|NCT03201419|183421372|SUPERIORITY||Least Square Mean Difference|-0.026||||0.8778|TWO_SIDED|95.0|-0.352|0.301||Threshold for significance at 0.05 level.|MMRM|||||0.301|-0.352|0.8778
91766128|NCT03201419|183421372|SUPERIORITY||Least Square Mean Difference|0.157||||0.4309|TWO_SIDED|95.0|-0.235|0.549||Threshold for significance at 0.05 level.|MMRM|||||0.549|-0.235|0.4309
91766129|NCT03201419|183421372|SUPERIORITY||Least Square Mean Difference|-0.017||||0.9392|TWO_SIDED|95.0|-0.444|0.411||Threshold for significance at 0.05 level.|MMRM|||||0.411|-0.444|0.9392
91766130|NCT03201419|183421372|SUPERIORITY||Least Square Mean Difference|-0.213||||0.1734|TWO_SIDED|95.0|-0.521|0.094||Threshold for significance at 0.05 level.|MMRM|||||0.094|-0.521|0.1734
91766131|NCT03201419|183421373|SUPERIORITY||Least Square Mean Difference|-0.328||||0.0133|TWO_SIDED|95.0|-0.587|-0.069||Threshold for significance at 0.05 level.|MMRM|||||-0.069|-0.587|0.0133
91766132|NCT03201419|183421373|SUPERIORITY||Least Square Mean Difference|-0.484||||0.0048|TWO_SIDED|95.0|-0.819|-0.15||Threshold for significance at 0.05 level.|MMRM|||||-0.150|-0.819|0.0048
91766133|NCT03201419|183421373|SUPERIORITY||Least Square Mean Difference|-0.04||||0.8223|TWO_SIDED|95.0|-0.395|0.314||Threshold for significance at 0.05 level.|MMRM|||||0.314|-0.395|0.8223
91766134|NCT03201419|183421373|SUPERIORITY||Least Square Mean Difference|0.215||||0.3083|TWO_SIDED|95.0|-0.2|0.63||Threshold for significance at 0.05 level.|MMRM|||||0.630|-0.200|0.3083
91766135|NCT03201419|183421373|SUPERIORITY||Least Square Mean Difference|-0.315||||0.1556|TWO_SIDED|95.0|-0.75|0.121||Threshold for significance at 0.05 level.|MMRM|||||0.121|-0.750|0.1556
91766136|NCT03201419|183421373|SUPERIORITY||Least Square Mean Difference|-0.188||||0.2423|TWO_SIDED|95.0|-0.504|0.128||Threshold for significance at 0.05 level.|MMRM|||||0.128|-0.504|0.2423
91766137|NCT03201419|183421374|SUPERIORITY||Least Square Mean Difference|-0.079||||0.6381|TWO_SIDED|95.0|-0.409|0.251||Threshold for significance at 0.05 level.|MMRM|||||0.251|-0.409|0.6381
91766138|NCT03201419|183421374|SUPERIORITY||Least Square Mean Difference|-0.502||||0.0221|TWO_SIDED|95.0|-0.931|-0.073||Threshold for significance at 0.05 level.|MMRM|||||-0.073|-0.931|0.0221
91766139|NCT03201419|183421374|SUPERIORITY||Least Square Mean Difference|-0.177||||0.4112|TWO_SIDED|95.0|-0.602|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.602|0.4112
91548883|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-5.4|-0.4||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||-0.4|-5.4|
91548884|NCT05093829|182979661|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|1.4|||||TWO_SIDED|95.0|-0.6|4.8||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||4.8|-0.6|
91548885|NCT05093829|182979662|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|2.3|||||TWO_SIDED|95.0|0.3|4.7||||||For the 9-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup W is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.7|0.3|
91548886|NCT05093829|182979662|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|1.9|||||TWO_SIDED|95.0|0.004|4.4||||||For the 15-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup Y is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.4|0.004|
91548887|NCT05093829|182979666|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|82.5|||||TWO_SIDED|95.0|76.4|87.2||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||87.2|76.4|
91766140|NCT03201419|183421374|SUPERIORITY||Least Square Mean Difference|0.112||||0.6761|TWO_SIDED|95.0|-0.416|0.64||Threshold for significance at 0.05 level.|MMRM|||||0.640|-0.416|0.6761
91766141|NCT03201419|183421374|SUPERIORITY||Least Square Mean Difference|0.224||||0.4898|TWO_SIDED|95.0|-0.414|0.861||Threshold for significance at 0.05 level.|MMRM|||||0.861|-0.414|0.4898
91548888|NCT05093829|182979666|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|68.4|||||TWO_SIDED|95.0|61.3|74.7||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||74.7|61.3|
91766142|NCT03201419|183421374|SUPERIORITY||Least Square Mean Difference|0.194||||0.3311|TWO_SIDED|95.0|-0.198|0.585||Threshold for significance at 0.05 level.|MMRM|||||0.585|-0.198|0.3311
91766143|NCT03201419|183421375|SUPERIORITY||Least Square Mean Difference|-0.23||||0.1583|TWO_SIDED|95.0|-0.551|0.09||Threshold for significance at 0.05 level.|MMRM|||||0.090|-0.551|0.1583
91766144|NCT03201419|183421375|SUPERIORITY||Least Square Mean Difference|-0.275||||0.1884|TWO_SIDED|95.0|-0.685|0.136||Threshold for significance at 0.05 level.|MMRM|||||0.136|-0.685|0.1884
91766145|NCT03201419|183421375|SUPERIORITY||Least Square Mean Difference|-0.047||||0.8256|TWO_SIDED|95.0|-0.463|0.369||Threshold for significance at 0.05 level.|MMRM|||||0.369|-0.463|0.8256
91766146|NCT03201419|183421375|SUPERIORITY||Least Square Mean Difference|0.059||||0.8198|TWO_SIDED|95.0|-0.455|0.574||Threshold for significance at 0.05 level.|MMRM|||||0.574|-0.455|0.8198
91766147|NCT03201419|183421375|SUPERIORITY||Least Square Mean Difference|-0.431||||0.1793|TWO_SIDED|95.0|-1.061|0.199||Threshold for significance at 0.05 level.|MMRM|||||0.199|-1.061|0.1793
91766148|NCT03201419|183421375|SUPERIORITY||Least Square Mean Difference|-0.196||||0.3155|TWO_SIDED|95.0|-0.581|0.189||Threshold for significance at 0.05 level.|MMRM|||||0.189|-0.581|0.3155
91766149|NCT03201419|183421376|SUPERIORITY||Least Square Mean Difference|-0.241||||0.183|TWO_SIDED|95.0|-0.596|0.114||Threshold for significance at 0.05 level.|MMRM|||||0.114|-0.596|0.1830
91766150|NCT03201419|183421376|SUPERIORITY||Least Square Mean Difference|-0.313||||0.1618|TWO_SIDED|95.0|-0.751|0.126||Threshold for significance at 0.05 level.|MMRM|||||0.126|-0.751|0.1618
91766151|NCT03201419|183421376|SUPERIORITY||Least Square Mean Difference|-0.26||||0.2519|TWO_SIDED|95.0|-0.706|0.186||Threshold for significance at 0.05 level.|MMRM|||||0.186|-0.706|0.2519
91766152|NCT03201419|183421376|SUPERIORITY||Least Square Mean Difference|0.232||||0.4044|TWO_SIDED|95.0|-0.316|0.781||Threshold for significance at 0.05 level.|MMRM|||||0.781|-0.316|0.4044
91766153|NCT03201419|183421376|SUPERIORITY||Least Square Mean Difference|-0.28||||0.4348|TWO_SIDED|95.0|-0.986|0.426||Threshold for significance at 0.05 level.|MMRM|||||0.426|-0.986|0.4348
91766154|NCT03201419|183421376|SUPERIORITY||Least Square Mean Difference|-0.15||||0.4786|TWO_SIDED|95.0|-0.565|0.266||Threshold for significance at 0.05 level.|MMRM|||||0.266|-0.565|0.4786
91766155|NCT03201419|183421377|SUPERIORITY||Least Square Mean Difference|-0.223||||0.2412|TWO_SIDED|95.0|-0.598|0.151||Threshold for significance at 0.05 level.|MMRM|||||0.151|-0.598|0.2412
91766156|NCT03201419|183421377|SUPERIORITY||Least Square Mean Difference|-0.48||||0.0501|TWO_SIDED|95.0|-0.959|0.0||Threshold for significance at 0.05 level.|MMRM|||||0.000|-0.959|0.0501
91766157|NCT03201419|183421377|SUPERIORITY||Least Square Mean Difference|0.069||||0.7788|TWO_SIDED|95.0|-0.417|0.556||Threshold for significance at 0.05 level.|MMRM|||||0.556|-0.417|0.7788
91766158|NCT03201419|183421377|SUPERIORITY||Least Square Mean Difference|-0.111||||0.7111|TWO_SIDED|95.0|-0.698|0.477||Threshold for significance at 0.05 level.|MMRM|||||0.477|-0.698|0.7111
91766159|NCT03201419|183421377|SUPERIORITY||Least Square Mean Difference|-0.205||||0.5816|TWO_SIDED|95.0|-0.937|0.527||Threshold for significance at 0.05 level.|MMRM|||||0.527|-0.937|0.5816
91766160|NCT03201419|183421377|SUPERIORITY||Least Square Mean Difference|-0.152||||0.4981|TWO_SIDED|95.0|-0.595|0.29||Threshold for significance at 0.05 level.|MMRM|||||0.290|-0.595|0.4981
91766161|NCT03201419|183421378|SUPERIORITY||Least Square Mean Difference|-1.313||||0.1733|TWO_SIDED|95.0|-3.207|0.582||Threshold for significance at 0.05 level.|MMRM|||||0.582|-3.207|0.1733
91766162|NCT03201419|183421378|SUPERIORITY||Least Square Mean Difference|-1.375||||0.2538|TWO_SIDED|95.0|-3.745|0.994||Threshold for significance at 0.05 level.|MMRM|||||0.994|-3.745|0.2538
91766163|NCT03201419|183421378|SUPERIORITY||Least Square Mean Difference|-0.353||||0.7782|TWO_SIDED|95.0|-2.818|2.113||Threshold for significance at 0.05 level.|MMRM|||||2.113|-2.818|0.7782
91766164|NCT03201419|183421378|SUPERIORITY||Least Square Mean Difference|-0.151||||0.9218|TWO_SIDED|95.0|-3.182|2.88||Threshold for significance at 0.05 level.|MMRM|||||2.880|-3.182|0.9218
91766165|NCT03201419|183421378|SUPERIORITY||Least Square Mean Difference|0.767||||0.6823|TWO_SIDED|95.0|-2.923|4.457||Threshold for significance at 0.05 level.|MMRM|||||4.457|-2.923|0.6823
91766166|NCT03201419|183421378|SUPERIORITY||Least Square Mean Difference|-1.095||||0.3436|TWO_SIDED|95.0|-3.369|1.179||Threshold for significance at 0.05 level.|MMRM|||||1.179|-3.369|0.3436
91766167|NCT03201419|183421379|SUPERIORITY||Least Square Mean Difference|-1.235||||0.2042|TWO_SIDED|95.0|-3.146|0.676||Threshold for significance at 0.05 level.|MMRM|||||0.676|-3.146|0.2042
91766168|NCT03201419|183421379|SUPERIORITY||Least Square Mean Difference|-1.683||||0.1591|TWO_SIDED|95.0|-4.031|0.665||Threshold for significance at 0.05 level.|MMRM|||||0.665|-4.031|0.1591
91766169|NCT03201419|183421379|SUPERIORITY||Least Square Mean Difference|-0.285||||0.8168|TWO_SIDED|95.0|-2.708|2.138||Threshold for significance at 0.05 level.|MMRM|||||2.138|-2.708|0.8168
91766170|NCT03201419|183421379|SUPERIORITY||Least Square Mean Difference|-0.551||||0.7148|TWO_SIDED|95.0|-3.517|2.416||Threshold for significance at 0.05 level.|MMRM|||||2.416|-3.517|0.7148
91766171|NCT03201419|183421379|SUPERIORITY||Least Square Mean Difference|0.701||||0.7141|TWO_SIDED|95.0|-3.066|4.468||Threshold for significance at 0.05 level.|MMRM|||||4.468|-3.066|0.7141
91766172|NCT03201419|183421379|SUPERIORITY||Least Square Mean Difference|-0.759||||0.5041|TWO_SIDED|95.0|-2.995|1.477||Threshold for significance at 0.05 level.|MMRM|||||1.477|-2.995|0.5041
91766173|NCT03201419|183421380|SUPERIORITY||Least Square Mean Difference|-1.129||||0.2896|TWO_SIDED|95.0|-3.226|0.967||Threshold for significance at 0.05 level.|MMRM|||||0.967|-3.226|0.2896
91766174|NCT03201419|183421380|SUPERIORITY||Least Square Mean Difference|-2.652||||0.0498|TWO_SIDED|95.0|-5.301|-0.003||Threshold for significance at 0.05 level.|MMRM|||||-0.003|-5.301|0.0498
91766175|NCT03201419|183421380|SUPERIORITY||Least Square Mean Difference|0.323||||0.8159|TWO_SIDED|95.0|-2.409|3.055||Threshold for significance at 0.05 level.|MMRM|||||3.055|-2.409|0.8159
91548889|NCT05093829|182979667|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.0|-1.0|
91548890|NCT05093829|182979667|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
91548891|NCT05093829|182979668|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.5|2.6||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.6|-10.5|
91548892|NCT05093829|182979668|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
91548893|NCT05093829|182979669|NON_INFERIORITY|The NmCV-5 co-administered yellow fever vaccine will be deemed non-inferior to the MenACWY-TT co-administered yellow fever vaccine in eliciting seroprotective response to yellow fever if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-1.9|||||TWO_SIDED|95.0|-4.2|0.6||||||For this comparison, the proportion of infants with a seroprotective response to yellow fever vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seroprotective response to yellow fever vaccine in the NmCV-5 arm to determine the difference in proportions.||0.6|-4.2|
91766176|NCT03201419|183421380|SUPERIORITY||Least Square Mean Difference|0.485||||0.7719|TWO_SIDED|95.0|-2.809|3.779||Threshold for significance at 0.05 level.|MMRM|||||3.779|-2.809|0.7719
91766177|NCT03201419|183421380|SUPERIORITY||Least Square Mean Difference|1.676||||0.4193|TWO_SIDED|95.0|-2.407|5.76||Threshold for significance at 0.05 level.|MMRM|||||5.760|-2.407|0.4193
91548894|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
91766178|NCT03201419|183421380|SUPERIORITY||Least Square Mean Difference|-1.23||||0.3333|TWO_SIDED|95.0|-3.73|1.27||Threshold for significance at 0.05 level.|MMRM|||||1.270|-3.730|0.3333
91766179|NCT03201419|183421381|SUPERIORITY||Mean Difference|41.8||||0.0853|TWO_SIDED|95.0|-5.9|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-5.9|0.0853
91766180|NCT03201419|183421381|SUPERIORITY||Mean Difference|105.9||||0.001|TWO_SIDED|95.0|43.4|168.4||Threshold for significance at 0.05 level.|MMRM|||||168.4|43.4|0.0010
91766181|NCT03201419|183421381|SUPERIORITY||Mean Difference|24.9||||0.4418|TWO_SIDED|95.0|-38.8|88.6||Threshold for significance at 0.05 level.|MMRM|||||88.6|-38.8|0.4418
91766182|NCT03201419|183421381|SUPERIORITY||Mean Difference|10.7||||0.7902|TWO_SIDED|95.0|-68.2|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-68.2|0.7902
91766183|NCT03201419|183421381|SUPERIORITY||Mean Difference|1.8||||0.9664|TWO_SIDED|95.0|-84.2|87.9||Threshold for significance at 0.05 level.|MMRM|||||87.9|-84.2|0.9664
91766184|NCT03201419|183421381|SUPERIORITY||Mean Difference|-29.8||||0.2977|TWO_SIDED|95.0|-85.9|26.4||Threshold for significance at 0.05 level.|MMRM|||||26.4|-85.9|0.2977
91766185|NCT03201419|183421382|SUPERIORITY||Mean Difference|14.3||||0.5523|TWO_SIDED|95.0|-33.0|61.5||Threshold for significance at 0.05 level.|MMRM|||||61.5|-33.0|0.5523
91766186|NCT03201419|183421382|SUPERIORITY||Mean Difference|60.8||||0.0556|TWO_SIDED|95.0|-1.5|123.0||Threshold for significance at 0.05 level.|MMRM|||||123.0|-1.5|0.0556
91766187|NCT03201419|183421382|SUPERIORITY||Mean Difference|-17.9||||0.5837|TWO_SIDED|95.0|-82.0|46.3||Threshold for significance at 0.05 level.|MMRM|||||46.3|-82.0|0.5837
91766188|NCT03201419|183421382|SUPERIORITY||Mean Difference|-60.7||||0.1363|TWO_SIDED|95.0|-140.7|19.3||Threshold for significance at 0.05 level.|MMRM|||||19.3|-140.7|0.1363
91766189|NCT03201419|183421382|SUPERIORITY||Mean Difference|-28.2||||0.4938|TWO_SIDED|95.0|-109.1|52.8||Threshold for significance at 0.05 level.|MMRM|||||52.8|-109.1|0.4938
91766190|NCT03201419|183421382|SUPERIORITY||Mean Difference|-54.7||||0.0535|TWO_SIDED|95.0|-110.2|0.8||Threshold for significance at 0.05 level.|MMRM|||||0.8|-110.2|0.0535
91766191|NCT03201419|183421383|SUPERIORITY||Mean Difference|-0.7||||0.9829|TWO_SIDED|95.0|-62.2|60.9||Threshold for significance at 0.05 level.|MMRM|||||60.9|-62.2|0.9829
91548895|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|1.2|||||TWO_SIDED|95.0|1.0|1.6|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.6|1.0|
91548896|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.6|0.4|
91548897|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|0.4|||||TWO_SIDED|95.0|0.3|0.5|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.5|0.3|
91548898|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.6|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.6|
91548899|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|1.6|||||TWO_SIDED|95.0|1.1|2.1|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||2.1|1.1|
91548900|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.6|1.0|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.0|0.6|
91548901|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
91766192|NCT03201419|183421383|SUPERIORITY||Mean Difference|64.4||||0.1038|TWO_SIDED|95.0|-13.3|142.1||Threshold for significance at 0.05 level.|MMRM|||||142.1|-13.3|0.1038
91766193|NCT03201419|183421383|SUPERIORITY||Mean Difference|29.2||||0.4764|TWO_SIDED|95.0|-51.4|109.8||Threshold for significance at 0.05 level.|MMRM|||||109.8|-51.4|0.4764
91766194|NCT03201419|183421383|SUPERIORITY||Mean Difference|-24.2||||0.6204|TWO_SIDED|95.0|-120.5|72.0||Threshold for significance at 0.05 level.|MMRM|||||72.0|-120.5|0.6204
91548902|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|1511.1|||||TWO_SIDED|95.0|1169.5|1952.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1952.4|1169.5|
91548903|NCT05093829|182979670|OTHER||Ratio of geometric mean titers|767.3|||||TWO_SIDED|95.0|553.2|1064.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1064.4|553.2|
91548904|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|2756.4|||||TWO_SIDED|95.0|1976.3|3844.5|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3844.5|1976.3|
91548905|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|2506.9|||||TWO_SIDED|95.0|1404.0|4476.1|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4476.1|1404.0|
91548906|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1179.0|||||TWO_SIDED|95.0|709.8|1958.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1958.6|709.8|
91548907|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1096.2|||||TWO_SIDED|95.0|513.4|2340.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2340.6|513.4|
91766195|NCT03201419|183421383|SUPERIORITY||Mean Difference|2.2||||0.966|TWO_SIDED|95.0|-100.1|104.6||Threshold for significance at 0.05 level.|MMRM|||||104.6|-100.1|0.9660
91766196|NCT03201419|183421383|SUPERIORITY||Mean Difference|3.3||||0.9275|TWO_SIDED|95.0|-67.4|73.9||Threshold for significance at 0.05 level.|MMRM|||||73.9|-67.4|0.9275
91766197|NCT03201419|183421384|SUPERIORITY||Mean Difference|15.7||||0.5964|TWO_SIDED|95.0|-42.7|74.2||Threshold for significance at 0.05 level.|MMRM|||||74.2|-42.7|0.5964
91766198|NCT03201419|183421384|SUPERIORITY||Mean Difference|-2.8||||0.9418|TWO_SIDED|95.0|-78.5|72.9||Threshold for significance at 0.05 level.|MMRM|||||72.9|-78.5|0.9418
91766199|NCT03201419|183421384|SUPERIORITY||Mean Difference|18.0||||0.6452|TWO_SIDED|95.0|-58.8|94.7||Threshold for significance at 0.05 level.|MMRM|||||94.7|-58.8|0.6452
91766200|NCT03201419|183421384|SUPERIORITY||Mean Difference|-51.3||||0.2565|TWO_SIDED|95.0|-140.2|37.6||Threshold for significance at 0.05 level.|MMRM|||||37.6|-140.2|0.2565
91548908|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|288.7|||||TWO_SIDED|95.0|212.6|392.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||392.0|212.6|
91548909|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|654.5|||||TWO_SIDED|95.0|385.5|1111.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1111.0|385.5|
91548910|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|287.9|||||TWO_SIDED|95.0|213.9|387.5|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||387.5|213.9|
91548911|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|834.6|||||TWO_SIDED|95.0|496.7|1402.3|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1402.3|496.7|
91548912|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1068.4|||||TWO_SIDED|95.0|683.3|1670.6|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1670.6|683.3|
91548913|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1933.1|||||TWO_SIDED|95.0|1224.7|3051.1|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3051.1|1224.7|
91548914|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|3163.1|||||TWO_SIDED|95.0|2247.5|4451.7|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4451.7|2247.5|
91548915|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1524.1|||||TWO_SIDED|95.0|913.5|2543.0|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2543.0|913.5|
91548916|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|799.4|||||TWO_SIDED|95.0|532.9|1199.4|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1199.4|532.9|
91548917|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1469.2|||||TWO_SIDED|95.0|995.3|2168.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2168.8|995.3|
91766201|NCT03201419|183421384|OTHER||Mean Difference|-21.6||||0.6605|TWO_SIDED|95.0|-118.6|75.4||Threshold for significance at 0.05 level.|MMRM|||||75.4|-118.6|0.6605
91766202|NCT03201419|183421384|SUPERIORITY||Mean Difference|3.4||||0.9191|TWO_SIDED|95.0|-62.6|69.4||Threshold for significance at 0.05 level.|MMRM|||||69.4|-62.6|0.9191
91548918|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|549.4|||||TWO_SIDED|95.0|371.8|811.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||811.8|371.8|
91548919|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|642.6|||||TWO_SIDED|95.0|309.2|1335.9|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1335.9|309.2|
91548920|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|2630.0|||||TWO_SIDED|95.0|2037.6|3394.6|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3394.6|2037.6|
91548921|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|2.0|||||TWO_SIDED|95.0|1.2|3.4|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.4|1.2|
91766203|NCT03201419|183421385|SUPERIORITY||Mean Difference|17.52|||||TWO_SIDED|95.0|-6.19|62.09||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||62.09|-6.19|
91766204|NCT03201419|183421385|SUPERIORITY||Mean Difference|12.78|||||TWO_SIDED|95.0|-0.73|55.89||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||55.89|-0.73|
91766205|NCT03201419|183421385|SUPERIORITY||Mean Difference|8.5|||||TWO_SIDED|95.0|-0.14|47.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||47.28|-0.14|
91766206|NCT03201419|183421385|SUPERIORITY||Mean Difference|3.29|||||TWO_SIDED|95.0|-0.01|28.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||28.07|-0.01|
91766207|NCT03201419|183421385|SUPERIORITY||Mean Difference|1.74|||||TWO_SIDED|95.0|0.0|17.9||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||17.90|-0.00|
91548922|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1431.2|||||TWO_SIDED|95.0|905.2|2262.9|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2262.9|905.2|
91548923|NCT05093829|182979672|OTHER||Ratio of geometric mean titers|1.7|||||TWO_SIDED|95.0|0.9|3.3|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.3|0.9|
91548924|NCT04318548|182979736|NON_INFERIORITY|NI was to be demonstrated if the lower limit (LL) of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M14459 (fHbp) strain was above (\>) 0.5|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority (NI) of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.77|
91548925|NCT04318548|182979736|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against 96217 (NadA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.04|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.04|0.75|
91548926|NCT04318548|182979736|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against NZ98/254 (PorA) strain was \>0.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.12|0.76|
91548927|NCT04318548|182979736|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M13520 (NHBA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.73|
91766208|NCT03201419|183421385|SUPERIORITY||Mean Difference|0.68|||||TWO_SIDED|95.0|0.0|7.55||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||7.55|-0.00|
91766209|NCT03201419|183421386|SUPERIORITY||Mean Difference|-0.173||||0.0196|TWO_SIDED|95.0|-0.318|-0.028||Threshold for significance at 0.05 level.|MMRM|||||-0.028|-0.318|0.0196
91766210|NCT03201419|183421386|SUPERIORITY||Mean Difference|-0.233||||0.0167|TWO_SIDED|95.0|-0.423|-0.043||Threshold for significance at 0.05 level.|MMRM|||||-0.043|-0.423|0.0167
91766211|NCT03201419|183421386|SUPERIORITY||Mean Difference|-0.208||||0.0352|TWO_SIDED|95.0|-0.401|-0.015||Threshold for significance at 0.05 level.|MMRM|||||-0.015|-0.401|0.0352
91766212|NCT03201419|183421386|SUPERIORITY||Mean Difference|-0.057||||0.6402|TWO_SIDED|95.0|-0.295|0.182||Threshold for significance at 0.05 level.|MMRM|||||0.182|-0.295|0.6402
91766213|NCT03201419|183421386|SUPERIORITY||Mean Difference|-0.121||||0.3602|TWO_SIDED|95.0|-0.381|0.139||Threshold for significance at 0.05 level.|MMRM|||||0.139|-0.381|0.3602
91766214|NCT03201419|183421386|SUPERIORITY||Mean Difference|0.074||||0.4018|TWO_SIDED|95.0|-0.099|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.099|0.4018
91766215|NCT03201419|183421387|SUPERIORITY||Mean Difference|-0.133||||0.1354|TWO_SIDED|95.0|-0.308|0.042||Threshold for significance at 0.05 level.|MMRM|||||0.042|-0.308|0.1354
91766216|NCT03201419|183421387|SUPERIORITY||Mean Difference|-0.091||||0.4238|TWO_SIDED|95.0|-0.315|0.133||Threshold for significance at 0.05 level.|MMRM|||||0.133|-0.315|0.4238
91766217|NCT03201419|183421387|SUPERIORITY||Mean Difference|-0.22||||0.0574|TWO_SIDED|95.0|-0.446|0.007||Threshold for significance at 0.05 level.|MMRM|||||0.007|-0.446|0.0574
91766218|NCT03201419|183421387|SUPERIORITY||Mean Difference|0.058||||0.6579|TWO_SIDED|95.0|-0.199|0.315||Threshold for significance at 0.05 level.|MMRM|||||0.315|-0.199|0.6579
91766219|NCT03201419|183421387|SUPERIORITY||Mean Difference|-0.17||||0.2337|TWO_SIDED|95.0|-0.45|0.11||Threshold for significance at 0.05 level.|MMRM|||||0.110|-0.450|0.2337
91766220|NCT03201419|183421387|SUPERIORITY||Mean Difference|-0.136||||0.1639|TWO_SIDED|95.0|-0.328|0.056||Threshold for significance at 0.05 level.|MMRM|||||0.056|-0.328|0.1639
91766221|NCT03201419|183421388|SUPERIORITY||Mean Difference|-87.2||||0.047|TWO_SIDED|95.0|-173.2|-1.2|||MMRM|||||-1.2|-173.2|0.0470
91766222|NCT03201419|183421388|SUPERIORITY||Mean Difference|-130.2||||0.0237|TWO_SIDED|95.0|-242.9|-17.6|||MMRM|||||-17.6|-242.9|0.0237
91766223|NCT03201419|183421388|SUPERIORITY||Mean Difference|-110.8||||0.0569|TWO_SIDED|95.0|-224.9|3.3|||MMRM|||||3.3|-224.9|0.0569
91766224|NCT03201419|183421388|SUPERIORITY||Mean Difference|-23.9||||0.7383|TWO_SIDED|95.0|-164.8|117.0|||MMRM|||||117.0|-164.8|0.7383
91766225|NCT03201419|183421388|SUPERIORITY||Mean Difference|-71.0||||0.3626|TWO_SIDED|95.0|-224.3|82.3|||MMRM|||||82.3|-224.3|0.3626
91548928|NCT04318548|182979737|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men A serogroup was \>0.5.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men A, at one month after the vaccination with MenACWY (at Day 31).||1.14|0.78|
91548929|NCT04318548|182979737|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men C serogroup was \>0.5.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men C, at one month after the vaccination with MenACWY (at Day 31).||1.44|0.86|
91548930|NCT04318548|182979737|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men W serogroup was \>0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.21|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men W, at one month after the vaccination with MenACWY (at Day 31).||1.21|0.82|
91548931|NCT04318548|182979737|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men Y serogroup was \>0.5.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men Y, at one month after the vaccination with MenACWY (at Day 31).||1.27|0.84|
91548932|NCT04318548|182979739|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M14459 (fHbp) strain at one month after the fisrt vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.64|
91548933|NCT04318548|182979739|OTHER||GMT Ratio|0.62|||||TWO_SIDED|95.0|0.49|0.77|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis 96217 (NadA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.77|0.49|
91766226|NCT03201419|183421388|SUPERIORITY||Mean Difference|23.4||||0.6524|TWO_SIDED|95.0|-78.9|125.7|||MMRM|||||125.7|-78.9|0.6524
91766227|NCT03201419|183421389|SUPERIORITY||Mean Difference|-49.5||||0.3273|TWO_SIDED|95.0|-148.9|49.9||Threshold for significance at 0.05 level.|MMRM|||||49.9|-148.9|0.3273
91766228|NCT03201419|183421389|SUPERIORITY||Mean Difference|-74.6||||0.25|TWO_SIDED|95.0|-202.0|52.9||Threshold for significance at 0.05 level.|MMRM|||||52.9|-202.0|0.2500
91766229|NCT03201419|183421389|SUPERIORITY||Mean Difference|-93.5||||0.1537|TWO_SIDED|95.0|-222.3|35.2||Threshold for significance at 0.05 level.|MMRM|||||35.2|-222.3|0.1537
91548934|NCT04318548|182979739|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis NZ98/254 (PorA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.58|
91766230|NCT03201419|183421389|SUPERIORITY||Mean Difference|33.6||||0.6515|TWO_SIDED|95.0|-113.1|180.3||Threshold for significance at 0.05 level.|MMRM|||||180.3|-113.1|0.6515
91766231|NCT03201419|183421389|SUPERIORITY||Mean Difference|-75.7||||0.3506|TWO_SIDED|95.0|-235.3|83.9||Threshold for significance at 0.05 level.|MMRM|||||83.9|-235.3|0.3506
91766232|NCT03201419|183421389|SUPERIORITY||Mean Difference|-85.4||||0.1255|TWO_SIDED|95.0|-194.8|24.1||Threshold for significance at 0.05 level.|MMRM|||||24.1|-194.8|0.1255
91766233|NCT02784171|183421396|SUPERIORITY|||||||0.0372|||||||Log Rank|||||||0.0372
91766234|NCT02701283|183421423|NON_INFERIORITY|Absolute non-inferiority margin was 0.06|Posterior Median of the Difference|0.999|||||TWO_SIDED|95.0||||The posterior probability of non-inferiority is \> 0.999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data at the interim analysis using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled Trial||||
91766235|NCT04266795|183421456|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.477|TWO_SIDED|95.0|0.61|1.6|||Log Rank|P-value was comparison of EFS between treatment groups and was based on the 1-sided stratified log-rank test statistic.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (randomization strata of age and AML subtype) and treatment as a factor in the model.|||1.60|0.61|=0.477
91766236|NCT00699660|183421473|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.|Regression, Linear|Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.||Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.||||<.001
91766237|NCT00699660|183421474|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<.01
91766238|NCT00699660|183421475|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Descriptive statistics on mean and standard deviation.|t-test, 2 sided|||||||>.05
91548935|NCT04318548|182979739|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.9|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M13520 (NHBA) at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.90|0.64|
91548936|NCT02651428|182979749|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0006|TWO_SIDED|95.0|0.14|0.62||The threshold significance level at the interim and final statistical analyses for the primary efficacy endpoint was 0.0294.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the survival functions for CRBSI between the two treatments. Based on 80% power to detect a 55% reduction in the risk of CRBSI relative to the control treatment, a 1:1 randomization, a 2-sided log-rank test, one interim analysis using the method of Pocock, and an overall alpha of 0.05, it was determined that 56 CRBSIs would be needed. These are the results of the final analysis.||0.62|0.14|0.0006
91548937|NCT02651428|182979750|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4161|TWO_SIDED|95.0|0.9|1.29||The threshold for statistical significance was p \< 0.05.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the time until catheter removal for any reason between the two treatments.||1.29|0.90|0.4161
91548938|NCT01333969|182979765|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.043|TWO_SIDED|95.0|-1.4|-0.02|||GEE|Regression analysis using the generalized estimating equations (GEE) method to compare the changes over time in VAS scores at rest and with exercise||||-0.02|-1.40|.043
91548939|NCT01333969|182979766|OTHER||Mean Difference (Final Values)|0.043||||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
91548940|NCT01333969|182979767|SUPERIORITY||Mean Difference (Final Values)|0.584||||0.584|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.584
91548941|NCT01333969|182979768|SUPERIORITY||Mean Difference (Final Values)|0.763||||0.763|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.763
91548942|NCT01333969|182979769|SUPERIORITY||Mean Difference (Final Values)|0.602||||0.602|TWO_SIDED||||||GEE|Regression analyses based on the generalized estimating equations (GEE) method||||||.602
91548943|NCT01333969|182979770|SUPERIORITY||Mean Difference (Final Values)|0.8656||||0.8656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8656
91548944|NCT01333969|182979771|SUPERIORITY||Mean Difference (Final Values)|0.8422||||0.8422|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8422
91548945|NCT01333969|182979772|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
91548946|NCT01333969|182979773|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
91548947|NCT01926496|182979840|SUPERIORITY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.99|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.99|0.80|0.03
91548948|NCT01926496|182979841|SUPERIORITY||Risk Ratio (RR)|0.95||||0.18|TWO_SIDED|95.0|0.87|1.03|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||1.03|0.87|0.18
91548949|NCT01926496|182979842|SUPERIORITY||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.84|0.52|<0.001
91548950|NCT02677298|182979843|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91766239|NCT00699660|183421476|SUPERIORITY_OR_OTHER||Slope|47.3|STANDARD_ERROR_OF_MEAN|18.86||0.012|TWO_SIDED|||||0.05 level based on a two tailed test.|Regression, Linear|Covariates included years of experience, use of template, use of tests, age, education, study site.||Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)||||.012
91548951|NCT02677298|182979844|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
91548952|NCT02677298|182979845|SUPERIORITY|||||||0.003||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.003
91766240|NCT03160898|183421485|SUPERIORITY||least squares mean treatment difference|1.61|STANDARD_ERROR_OF_MEAN|1.003||0.1095|TWO_SIDED|95.0|-0.36|3.58|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||"The statistical null hypothesis was as follows: there was no assumed dose-response relationship in percent predicted SVC change from baseline to Week 12 among all three active doses and placebo, expressed as:~H0: -5 x µ placebo - 1 x µ 150 mg twice daily + 3 x µ 300 mg twice daily + 3 x µ 450 mg twice daily = 0 where µ was the mean of the efficacy endpoint for the designated group."||3.58|-0.36|0.1095
91766241|NCT03160898|183421485|SUPERIORITY||Least squares mean difference|1.49|STANDARD_ERROR_OF_MEAN|1.291||0.2501|TWO_SIDED|95.0|-1.05|4.03|||Mixed Models Analysis|||||4.03|-1.05|0.2501
91766242|NCT03160898|183421485|SUPERIORITY||Least squares mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.29||0.1549|TWO_SIDED|95.0|-0.7|4.38|||Mixed Models Analysis|||||4.38|-0.7|0.1549
91766243|NCT03160898|183421485|SUPERIORITY||Least squares mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.274||0.1417|TWO_SIDED|95.0|-0.63|4.38|||Mixed Models Analysis|||||4.38|-0.63|0.1417
91766244|NCT03160898|183421485|SUPERIORITY||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|1.115||0.0964|TWO_SIDED|95.0|-0.33|4.05|||Mixed Models Analysis|||||4.05|-0.33|0.0964
91766245|NCT03160898|183421486|SUPERIORITY||Least squares mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.335||0.093|TWO_SIDED|95.0|-0.09|1.22|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||1.22|-0.09|0.0930
91766246|NCT03160898|183421486|SUPERIORITY||Least squares mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.427||0.0087|TWO_SIDED|95.0|0.29|1.97|||Mixed Models Analysis|||||1.97|0.29|0.0087
91766247|NCT03160898|183421486|SUPERIORITY||Least squares mean difference|0.91|STANDARD_ERROR_OF_MEAN|0.43||0.0351|TWO_SIDED|95.0|0.06|1.75|||Mixed Models Analysis|||||1.75|0.06|0.0351
91766248|NCT03160898|183421486|SUPERIORITY||Least squares mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.425||0.1642|TWO_SIDED|95.0|-0.24|1.43|||Mixed Models Analysis|||||1.43|-0.24|0.1642
91766249|NCT03160898|183421486|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.371||0.0435|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.0435
91548953|NCT02677298|182979846|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
91548954|NCT02677298|182979846|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
91766250|NCT03160898|183421487|SUPERIORITY||Slope difference|0.0276|STANDARD_ERROR_OF_MEAN|0.02734||0.3134|TWO_SIDED|95.0|-0.0261|0.0813|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||0.0813|-0.0261|0.3134
91766251|NCT03160898|183421487|SUPERIORITY||Least squares mean difference|0.0246||||0.4824|TWO_SIDED|95.0|-0.0442|0.0935|||Mixed Models Analysis|||||0.0935|-0.0442|0.4824
91766252|NCT03160898|183421487|SUPERIORITY||Least squares mean difference|0.0146||||0.6787|TWO_SIDED|95.0|-0.0544|0.0835|||Mixed Models Analysis|||||0.0835|-0.0544|0.6787
91766253|NCT03160898|183421487|SUPERIORITY||Least squares mean difference|0.0488||||0.1604|TWO_SIDED|95.0|-0.0194|0.1171|||Mixed Models Analysis|||||0.1171|-0.0194|0.1604
91766254|NCT03160898|183421487|SUPERIORITY||Least squares mean difference|0.0317||||0.2966|TWO_SIDED|95.0|-0.0279|0.0913|||Mixed Models Analysis|||||0.0913|-0.0279|0.2966
91766255|NCT04186871|183421554|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-27.8|||||TWO_SIDED|95.0|-77.5|21.9||||||||21.9|-77.5|
91766256|NCT04186871|183421554|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.32||||0.3117|TWO_SIDED|95.0|0.04|2.73|||Cochran-Mantel-Haenszel|||||2.73|0.04|0.3117
91766257|NCT04186871|183421555|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||||4.9|-2.8|
91766258|NCT04186871|183421555|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-11.5|-5.0||||||||-5.0|-11.5|
91766259|NCT04186871|183421555|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-9.3|-5.2||||||||-5.2|-9.3|
91766260|NCT04186871|183421556|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|16.7|||||TWO_SIDED|95.0|-31.8|65.2||||||||65.2|-31.8|
91766261|NCT04186871|183421556|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.22|18.04||||||||18.04|0.22|
91766262|NCT04186871|183421557|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-11.9|||||TWO_SIDED|95.0|-57.1|33.3||||||||33.3|-57.1|
91548955|NCT02677298|182979847|SUPERIORITY|||||||0.084||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.084
91548956|NCT02677298|182979848|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for the Modified Skindex-16 (GL-QoL) Emotional domain change from baseline at week 4||||<0.001
91548957|NCT02677298|182979848|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Functioning domain - Change from baseline at Week 4||||<0.001
91766263|NCT04186871|183421557|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.4||||0.593|TWO_SIDED|95.0|0.02|10.02|||Cochran-Mantel-Haenszel|||||10.02|0.02|0.5930
91548958|NCT02677298|182979848|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Overall score||||<0.001
91548959|NCT02677298|182979848|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Appraisal of Lines Between Eyebrows Scale - Change from Baseline at Week 4||||<0.001
91766264|NCT04186871|183421558|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-14.6|||||TWO_SIDED|95.0|-36.9|7.7||||||||7.7|-36.9|
91766265|NCT04186871|183421558|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.46||||0.1639|TWO_SIDED|95.0|0.15|1.39|||Chi-squared|||||1.39|0.15|0.1639
91766266|NCT04186871|183421559|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE WEEK 12|Mean Difference (Final Values)|-1.61|||||TWO_SIDED|95.0|-2.11|-1.11||||||||-1.110|-2.110|
91766267|NCT04186871|183421559|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.567|||||TWO_SIDED|95.0|-1.855|-1.28||||||||-1.280|-1.855|
91548960|NCT02677298|182979848|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Age Appraisal VAS score||||<0.001
91548961|NCT03210272|182979887|OTHER||Geometric Mean Ratio T/R (%)|155.6|||||TWO_SIDED|90.0|130.66|185.3|||||intra-individual gCV (%) = 18.1|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||185.30|130.66|
91548962|NCT03210272|182979887|OTHER||Ratio T/R (%)|240.12|||||TWO_SIDED|90.0|196.25|293.81|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||293.81|196.25|
91548963|NCT03210272|182979888|OTHER||Geometric Mean Ratio T/R (%)|156.37|||||TWO_SIDED|90.0|132.73|184.22|||||intra-individual gCV (%) = 17.0|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||184.22|132.73|
91548964|NCT03210272|182979888|OTHER||Ratio T/R (%)|245.56|||||TWO_SIDED|90.0|200.7|300.44|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||300.44|200.70|
91548965|NCT03210272|182979889|OTHER||Geometric Mean Ratio T/R (%)|158.74|||||TWO_SIDED|90.0|114.25|220.56|||||intra-individual gCV (%) = 34.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||220.56|114.25|
91766268|NCT04186871|183421559|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.534|0.62||||||||0.620|-0.534|
91766269|NCT04186871|183421560|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.741|||||TWO_SIDED|95.0|-2.256|-1.226||||||||-1.226|-2.256|
91766270|NCT04186871|183421560|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.698|||||TWO_SIDED|95.0|-1.998|-1.399||||||||-1.399|-1.998|
91766271|NCT04186871|183421560|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.553|0.639||||||||0.639|-0.553|
91766272|NCT04186871|183421561|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-19.495|||||TWO_SIDED|95.0|-24.861|-14.128||||||||-14.128|-24.861|
91766273|NCT04186871|183421561|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-18.767|||||TWO_SIDED|95.0|-21.848|-15.686||||||||-15.686|-21.848|
91766274|NCT04186871|183421561|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.728|||||TWO_SIDED|95.0|-5.463|6.919||||||||6.919|-5.463|
91766275|NCT04186871|183421562|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-19.2|||||TWO_SIDED|95.0|-24.3|-14.1||||||||-14.1|-24.3|
91766276|NCT04186871|183421562|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-18.5|||||TWO_SIDED|95.0|-21.4|-15.5||||||||-15.5|-21.4|
91766277|NCT04186871|183421562|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-5.2|6.6||||||||6.6|-5.2|
91766278|NCT04186871|183421563|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-4.1|||||TWO_SIDED|95.0|-28.1|19.9||||||||19.9|-28.1|
91766279|NCT04186871|183421563|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.31|2.32||||||||2.32|0.31|
91548966|NCT03210272|182979889|OTHER||Ratio T/R (%)|246.13|||||TWO_SIDED|90.0|203.37|297.89|||||intra-individual gCV (%) = 26.2|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||297.89|203.37|
91548967|NCT03064217|182979907|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91548968|NCT02143726|182979908|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0918|TWO_SIDED|95.0|0.23|1.33|||Log Rank|Stratified 1-sided log-rank test (stratified by ECOG performance status, prior systemic treatment for hürthle thyroid cancer, and treating site).||||1.33|0.23|0.0918
91548969|NCT02143726|182979910|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.3976|TWO_SIDED|95.0|0.53|4.96|||Log Rank|||||4.96|0.53|0.3976
91548970|NCT01715285|182979996|SUPERIORITY||Hazard Ratio (HR)|0.466|||<|0.0001|TWO_SIDED|95.0|0.394|0.55|||Log Rank|||||0.550|0.394|<0.0001
91548971|NCT01715285|182979997|SUPERIORITY||Hazard Ratio (HR)|0.661|||<|0.0001|TWO_SIDED|95.0|0.564|0.775|||Log Rank|||||0.775|0.564|< 0.0001
91548972|NCT05020249|182980003|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
91548973|NCT05020249|182980004|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
91766280|NCT04186871|183421564|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-6.5|||||TWO_SIDED|95.0|-22.8|9.9||||||||9.9|-22.8|
91766281|NCT04186871|183421564|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.11|2.34||||||||2.34|0.11|
91766282|NCT00549445|183421574|OTHER|Student t test||||||0.045||||||Threshold for significance is P-Value \< 0.05|t-test, 1 sided|||||||0.045
91548974|NCT05020249|182980005|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
91548975|NCT05020249|182980006|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
91548976|NCT05020249|182980007|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
91548977|NCT05020249|182980008|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
91548978|NCT05020249|182980009|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
91548979|NCT05020249|182980010|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
91548980|NCT05020249|182980011|SUPERIORITY||Odds Ratio (OR)|81.25|||<|0.001|TWO_SIDED|95.0|8.216|803.544||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of scalp IGA response for bimekizumab group compared with placebo group using CMH.||803.544|8.216|<0.001
91548981|NCT05020249|182980012|SUPERIORITY||Odds Ratio (OR)|12.353||||0.007|TWO_SIDED|95.0|1.447|105.443||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of DLQI total score response for bimekizumab group compared with placebo group using CMH.||105.443|1.447|0.007
91548982|NCT05020249|182980013|SUPERIORITY||LS Mean Difference|-80.444|||<|0.001|TWO_SIDED|95.0|-102.509|-58.379|||ANCOVA|||||-58.379|-102.509|<0.001
91548983|NCT02761057|182980029|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.019|TWO_SIDED|95.0|0.37|0.97|||Regression, Cox|||A proportional hazards model was used to compare the Hazard Ratio (HR) for PFS.||0.97|0.37|0.019
91548984|NCT02761057|182980030|SUPERIORITY|||||||0.1|||||||Chi-squared|||The Chi-Square test will be used to compare RR between sunitinib and cabozantinib.||||0.10
91548985|NCT02761057|182980031|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.47|1.51|||Log Rank|||The log-rank test will be used to compare OS.||1.51|0.47|
91548986|NCT04971681|182980034|SUPERIORITY||||||<|0.27|||||||t-test, 2 sided|||||||<0.27
91548987|NCT04971681|182980035|SUPERIORITY||||||<|0.1|||||||t-test, 2 sided|||||||<0.10
91548988|NCT00686335|182980036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_DEVIATION|6.07|||TWO_SIDED|95.0|-13.5|-2.2||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.|Other|As this was an explorative study, no hypothesis testing was performed. All analyses were descriptive.||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.||-2.2|-13.5|
91548989|NCT03798093|182980037|SUPERIORITY||least squares|-0.112||||0.08|TWO_SIDED|95.0|-29.3|1.7|||Regression, Linear|||||1.7|-29.3|0.08
91548990|NCT05603143|182980055|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
91548991|NCT05603143|182980059|OTHER|||||||0.3219|||||||Log Rank|||||||0.3219
91548992|NCT05603143|182980060|OTHER||Hazard Ratio (HR)|1.496||||0.6568|TWO_SIDED|95.0|0.25|8.952|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||8.952|0.250|0.6568
91548993|NCT05603143|182980061|OTHER||Hazard Ratio (HR)|2.99||||0.319|TWO_SIDED|95.0|0.311|28.74|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||28.740|0.311|0.3190
91548994|NCT05603143|182980062|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
91548995|NCT05603143|182980063|OTHER||Hazard Ratio (HR)|1.425||||0.0859|TWO_SIDED|95.0|0.961|2.112||P-value was based on stratified Log-rank test with randomization stratification factors as the strata.|Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factors as covariates.|||2.112|0.961|0.0859
91548996|NCT05603143|182980064|OTHER||Treatment Difference (vs Placebo)|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||MMRM||Least-squares mean (SE), 95% CI and P value were from MMRM with baseline viral load and randomization strata as covariates.|||-0.33|-0.83|< 0.0001
91548997|NCT01743807|182980085|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91548998|NCT01814813|182980091|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
91548999|NCT01814813|182980092|SUPERIORITY||||||<|0.01|||||||Log Rank|||||||<0.01
91766283|NCT03932760|183421575|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.913|STANDARD_ERROR_OF_MEAN|1.085||0.612|TWO_SIDED|95.0|-1.228|3.055|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of EPDS between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum controlling for screening EPDS score. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher EPDS scores signify worsened symptoms of depression. Time uses start of study as reference controlling for screen EPDS.~Group VCI (AC reference): F=0.260, p=0.612~Time (Baseline as reference): F=9.021, p\<0.001~Group\*Time: F=0.537, p=0.748~Estimates for group, time, and group\*time interactions~Group:~Estimate=0.913 (SE=1.085) \[CI LB=-1.228, UB=3.055\]~Time:~Post: estimate=-2.766 (0.853) \[-4.445, -1.087\]~2 months: estimate=-1.517 (0.862) \[-3.214, 0.180\]~4 months: estimate=-3.186 (0.862) \[-4.883, -1.489\]~6 months: estimate=-2.781 (0.872) \[-4.498, -1.065\]~8 months: estimate=-3.103 (0.872) \[-4.819, -1.386\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|3.055|-1.228|0.612
91549000|NCT01814813|182980093|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
91549001|NCT04938492|182980094|SUPERIORITY||Slope|2.08|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
91549002|NCT04938492|182980095|SUPERIORITY||Slope|0.19|||<|0.001|TWO_SIDED||||||Latent growth modeling|||||||<.001
91549003|NCT04938492|182980096|SUPERIORITY||Slope|0.22|||<|0.01|TWO_SIDED||||||Latent growth modeling|||||||<.01
91549004|NCT04938492|182980097|SUPERIORITY||Slope|0.23|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
91549005|NCT03865498|182980098|SUPERIORITY||Odds Ratio (OR)|7.029|||<|0.0001|TWO_SIDED|95.0|4.919|10.323||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for African American dementia caregiver networks.||10.323|4.919|< 0.0001
91549006|NCT03865498|182980098|SUPERIORITY||Odds Ratio (OR)|17.385|||<|0.0001|TWO_SIDED|95.0|9.963|33.157||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for Hispanic dementia caregiver networks.||33.157|9.963|<0.0001
91549007|NCT03865498|182980098|SUPERIORITY||Odds Ratio (OR)|1.021||||0.924|TWO_SIDED|95.0|0.787|1.325||Pearson's Chi-squared test with Yates' continuity correction|Chi-squared, Corrected|||There will be no significant differences in isolated macro-level network structure from Tweets between Hispanic and African American dementia caregiver networks.||1.325|0.787|0.924
91549008|NCT03865498|182980099|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|0.628|||<|0.0001|TWO_SIDED|95.0|0.513|0.742|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for African American dementia caregiver networks.||0.742|0.513|<0.0001
91549009|NCT03865498|182980099|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|1.41|||<|0.0001|TWO_SIDED|95.0|1.189|1.631|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for Hispanic dementia caregiver networks.||1.631|1.189|<0.0001
91549010|NCT03865498|182980099|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.6|TWO_SIDED|95.0|-0.186|0.107|||t-test, 2 sided|||There will be no significant differences in emotional valence score detected from Tweets between Hispanic and African American dementia caregiver networks.||0.107|-0.186|0.600
91549011|NCT03994653|182980138|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.07|4.12|||Fisher Exact|||"Fishers exact test, conducted at each month prior to diagnosis comparing total purchases of relevant products (pain and indigestion medication) compared with all purchases in both cases and controls.~Power calculation: we used a power calculation assuming the Fisher Exact Test to calculate the minimum group size to detect a difference in purchase proportions that we hypothesised with 80% statistical power."||4.12|2.07|<0.001
91766284|NCT03932760|183421576|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.016|STANDARD_ERROR_OF_MEAN|0.859||0.558|TWO_SIDED|95.0|-1.709|1.677|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of GAD-7 between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher GAD-7 scores signify worsened symptoms of depression.~Group VCI (AC reference): F=0.347, p=0.558~Time (Baseline as reference): F=4.973, p\<0.001~Group\*Time: F=0.417, p=0.837~Estimates for group, time, and group\*time interactions~Group:~Estimate=-0.0160 (SE=0.859) \[CI LB=-1.709, UB=1.677\]~Time:~Post: estimate=-1.780 (0.708) \[-3.173, -0.387\]~2 months: estimate=-0.615 (0.715) \[-2.023, 0.792\]~4 months: estimate=-1.416 (0.715) \[-2.824, -0.008\]~6 months: estimate=-1.625 (0.723) \[-3.049, -0.201\]~8 months: estimate=-1.542 (0.723) \[-2.966, -0.118\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|1.677|-1.709|0.558
91549012|NCT03931174|182980140|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Odds Ratio (OR)|2.41|STANDARD_ERROR_OF_MEAN|0.53||0.097|TWO_SIDED|95.0|0.85|6.81||CM Exposure is reported as the estimated proportion of providers delivering 10 or more CM sessions to at least one patient in a mixed model accounting for nesting.|Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||6.81|0.85|0.097
91549013|NCT03931174|182980141|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.31||0.02|TWO_SIDED|95.0|0.11|1.32|||t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||1.32|0.11|0.02
91549014|NCT03931174|182980142|SUPERIORITY|Unit of analysis is the organization-level. Total number of organizations included in the analysis is 28 (14 ATTC, 14 E-ATTC).|Chi-square test statistic value|0.662||||0.43|TWO_SIDED||||||Chi-squared|Pearson Chi-Square||These analyses are unadjusted.||||0.430
91549015|NCT03931174|182980143|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.695|STANDARD_ERROR_OF_MEAN|0.313||0.034|TWO_SIDED|95.0|-1.3|-0.08|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||-0.08|-1.30|.034
91766285|NCT01875159|183421604|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE gamma regression models|||\>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour \<90% oxygen saturation/hour of recording||||<0.05
91549016|NCT03931174|182980144|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.314||0.27|TWO_SIDED|95.0|-0.82|0.41|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.41|-0.82|0.27
91549017|NCT03931174|182980145|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.191||0.011|TWO_SIDED|95.0|-0.88|0.12||Means were compared between conditions in an independent-samples T-test.|t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.12|-0.88|.011
91549018|NCT03931174|182980146|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.232||0.218|TWO_SIDED|95.0|-0.75|0.17||Means of leadership engagement scores were compared between conditions in an independent-samples T-test.|t-test, 2 sided|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.17|-0.75|.218
91549019|NCT05386030|182980147|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
91549020|NCT05386030|182980148|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
91549021|NCT03492216|182980166|SUPERIORITY||Risk Difference (RD)|7.6||||0.0025|TWO_SIDED|95.0|2.7|12.5|||Regression, Logistic||adjusted risk difference for non-hazardous alcohol use, alcohol incentive groups compared to no alcohol incentive groups. logistic regression model adjusted for INH incentive arm, participant sex, and study site.|||12.5|2.7|0.0025
91549022|NCT03492216|182980167|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9435|TWO_SIDED|95.0|-7.0|6.5|||Regression, Logistic||adjusted risk difference for \>90% INH adherence, INH incentive group compared to no INH incentives. logistic regression model adjusted for alcohol incentive arm, participant sex and study site.|||6.5|-7.0|0.9435
91549023|NCT03492216|182980170|SUPERIORITY||Risk Difference (RD)|-2.5||||0.26|TWO_SIDED|95.0|-6.8|1.9|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 2 (escalating incentives; EtG tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||1.9|-6.8|0.26
91549024|NCT03492216|182980170|SUPERIORITY||Risk Difference (RD)|0.7||||0.7|TWO_SIDED|95.0|-2.8|4.1|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 3 (escalating incentives; IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.1|-2.8|0.70
91549025|NCT03492216|182980170|SUPERIORITY||Risk Difference (RD)|1.3||||0.42|TWO_SIDED|95.0|-1.9|4.5|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 4 (escalating incentives; EtG and IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.5|-1.9|0.42
91549026|NCT00812461|182980181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.68||0.012|TWO_SIDED|95.0|-3.07|-0.38|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.38|-3.07|0.012
91766286|NCT05736874|183421608|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.91|
91766287|NCT05736874|183421609|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||||Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||4.68|0.19|
91766288|NCT05736874|183421612|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|3.5|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||3.5|0.8|
91766289|NCT05736874|183421613|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.62|1.63|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.63|0.62|
91766290|NCT05736874|183421614|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.42|1.5|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.50|0.42|
91766291|NCT05736874|183421615|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors|Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|0.5|5.94|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||5.94|0.50|
91766292|NCT05736874|183421616|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.11|0.69|
91549027|NCT00812461|182980182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.95|STANDARD_ERROR_OF_MEAN|2.89||0.088|TWO_SIDED|95.0|-10.63|0.73|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.73|-10.63|0.088
91549028|NCT00812461|182980183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.67|1.27|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.27|0.67|0.630
91549029|NCT00812461|182980184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.02|-0.44|0.029
91549030|NCT00812461|182980185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.111|TWO_SIDED|95.0|-0.38|0.04|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||0.04|-0.38|0.111
91549031|NCT00812461|182980186|SUPERIORITY_OR_OTHER||Ratio to placebo|0.96||||0.529|TWO_SIDED|95.0|0.86|1.08|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 224 participants in the placebo group and 207 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.08|0.86|0.529
91549032|NCT00812461|182980187|SUPERIORITY_OR_OTHER||Ratio to placebo|0.92||||0.049|TWO_SIDED|95.0|0.84|1.0|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 222 participants in the placebo group and 205 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.00|0.84|0.049
91549033|NCT03953508|182980289|OTHER|Analysis of covariance test|||||>|0.05||||||Threshold for significance is p\<.05|ANCOVA|||||||>.05
91766293|NCT05736874|183421616|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.34|0.78|
91549034|NCT03953508|182980290|OTHER|T-test comparing differences, the null hypothesis is that the groups are equal|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
91549035|NCT03953508|182980291|OTHER|Analysis of variance test comparing average breakpoint for menthol and non-menthol smokers|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
91549036|NCT03953508|182980292|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
91549037|NCT03953508|182980293|OTHER|Analysis of variance|||||>|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||>.05
91549038|NCT03953508|182980294|OTHER|Analysis of variance|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
91549039|NCT03953508|182980295|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
91549040|NCT03953508|182980296|OTHER|Fisher's exact test|||||>|0.05||||||Threshold for significance is p\<.05|Fisher Exact|||||||>.05
91549041|NCT03953508|182980297|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
91549042|NCT03953508|182980298|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
91549043|NCT01606215|182980310|OTHER|||||||0.84|||||||t-test, 2 sided|||Week 4 data||||0.84
91549044|NCT01606215|182980310|OTHER|||||||0.62|||||||t-test, 2 sided|||Week 12 data||||0.62
91549045|NCT01606215|182980310|OTHER|||||||0.61|||||||t-test, 2 sided|||Week 24 data||||0.61
91549046|NCT01606215|182980313|OTHER|||||||0.77|||||||t-test, 2 sided|||Week 4||||0.77
91549047|NCT01606215|182980313|OTHER|||||||0.68|||||||t-test, 2 sided|||Week 12||||0.68
91549048|NCT01606215|182980313|OTHER|Week 24||||||0.48|||||||t-test, 2 sided|||Week 24||||0.48
91549049|NCT05505292|182980337|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91549050|NCT05505292|182980338|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91549051|NCT05505292|182980339|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
91549052|NCT05505292|182980340|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
91766294|NCT05736874|183421616|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.45|0.78|
91549053|NCT05505292|182980341|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91549054|NCT05505292|182980342|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
91549055|NCT05505292|182980343|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Question 1a Change from baseline to week 8 in lifitegrast vs vehicle||||0.62
91549056|NCT05505292|182980343|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Question 1b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.53
91766295|NCT05736874|183421616|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.79|1.53|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.53|0.79|
91766296|NCT05736874|183421617|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.09|0.72|
91766297|NCT05736874|183421617|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.27|0.84|
91549057|NCT05505292|182980343|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Question 2a change from baseline to week 8 in lifitegrast vs vehicle groups||||0.66
91549058|NCT05505292|182980343|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Question 2b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.81
91549059|NCT05505292|182980343|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Question 3a change from baseline to week 8 in lifitegrast vs vehicle groups||||>0.999
91549060|NCT05505292|182980343|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Question 3b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.47
91549061|NCT05505292|182980343|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Question 4 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.52
91549062|NCT05505292|182980343|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Question 5 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.69
91549063|NCT05337306|182980350|SUPERIORITY|ANCOVA controlling for study arm and baseline||||||0.049||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|covariates include arm and baseline level of outcome||Last Observation Carried Forward (LOCF) for those lost to follow up; null hypothesis group 1 follow-up outcome = group 2 follow-up outcome.||||.049
91549064|NCT05337306|182980351|SUPERIORITY|||||||0.04||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|Covariates include trial arm and baseline level of outcome.||LOCF for lost to follow-up||||.040
91549065|NCT05337306|182980352|SUPERIORITY|||||||0.22|||||||ANCOVA|covariates include trial arm and baseline level of outcome.||LOCF for dropout/lost to follow up||||.220
91549066|NCT02677805|182980436|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91549067|NCT02677805|182980437|SUPERIORITY|||||||0.087||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.087
91549068|NCT02677805|182980438|SUPERIORITY|||||||0.121||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.121
91549069|NCT02677805|182980439|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
91549070|NCT02677805|182980439|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
91549071|NCT02677805|182980440|SUPERIORITY|||||||0.218||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.218
91549072|NCT02677805|182980441|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
91549073|NCT02677805|182980441|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
91549074|NCT02677805|182980441|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
91549075|NCT02677805|182980441|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
91549076|NCT02677805|182980441|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
91549077|NCT02301910|182980548|NON_INFERIORITY|The calculation was carried out taking into account the power of 80%||||||0.87|||||||ANOVA|||||||0.87
91549078|NCT04282148|182980557|SUPERIORITY||||||<|0.0001|||||||Z test using Kaplan Meier survival estim|||||||<0.0001
91549079|NCT05089019|182980627|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.889|||||TWO_SIDED|94.12|0.81|0.976|||Mixed Models Analysis|Ratio of Geometric Least Square (LS) Mean||||0.976|0.810|
91766298|NCT05736874|183421617|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.20|0.76|
91549080|NCT05089019|182980628|EQUIVALENCE|Equivalence margin 80% to 125%.|Ratio of Geometric LS Mean|0.927|||||TWO_SIDED|94.12|0.882|0.975|||Mixed Models Analysis|||||0.975|0.882|
91549081|NCT05089019|182980629|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.891|||||TWO_SIDED|94.12|0.834|0.951|||Mixed Models Analysis|||||0.951|0.834|
91549082|NCT03808818|182980638|EQUIVALENCE|the smallest detectable difference will be 22%|Odds Ratio (OR)|2.3||||0.0046|TWO_SIDED|95.0|1.28|4.13||No correction for multiple comparisons|Chi-squared|||"For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.~The primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups."||4.13|1.28|0.0046
91766299|NCT05736874|183421617|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.32|0.84|
91766300|NCT05736874|183421618|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.58|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.58|
91766301|NCT05736874|183421618|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.32|0.76|
91549083|NCT03808818|182980639|EQUIVALENCE|the smallest detectable difference will be 22% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 28%.|Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.04|3.33|||Chi-squared|||7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%||3.33|1.04|0.035
91549084|NCT03808818|182980640|EQUIVALENCE|the smallest detectable difference will be 21% with 80% power and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%.||||||0.016|||||||Chi-squared|||power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%||||0.016
91549085|NCT03808818|182980642|EQUIVALENCE|no margin||||||0.069|||||||Chi-squared|||||||0.069
91549086|NCT03808818|182980643|EQUIVALENCE|no margin||||||0.86|||||||Chi-squared|||||||0.86
91549087|NCT03808818|182980655|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
91549088|NCT03808818|182980656|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
91549089|NCT03808818|182980657|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
91549090|NCT03808818|182980659|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
91549091|NCT03858634|182980660|SUPERIORITY||Least squares (LS) mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.31||0.398|TWO_SIDED|80.0|-8.68|2.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||2.17|-8.68|0.3980
91549092|NCT03858634|182980660|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.23||0.6653|TWO_SIDED|80.0|-2.17|1.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||1.09|-2.17|0.6653
91549093|NCT03858634|182980660|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.14||0.0711|TWO_SIDED|80.0|-11.63|-3.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-3.56|-11.63|0.0711
91549094|NCT03858634|182980660|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|1.2||0.0186|TWO_SIDED|80.0|-4.7|-1.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-1.51|-4.70|0.0186
91549095|NCT03858634|182980662|SUPERIORITY||LS mean difference|-7.3|STANDARD_ERROR_OF_MEAN|14.76||0.6533|TWO_SIDED|80.0|-31.52|16.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||16.84|-31.52|0.6533
91549096|NCT03858634|182980662|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|10.51||0.9077|TWO_SIDED|80.0|-15.16|12.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||12.69|-15.16|0.9077
91549097|NCT03858634|182980662|SUPERIORITY||LS mean difference|-61.2|STANDARD_ERROR_OF_MEAN|33.18||0.2065|TWO_SIDED|80.0|-123.73|1.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1.39|-123.73|0.2065
91549098|NCT03858634|182980662|SUPERIORITY||LS mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.19||0.1133|TWO_SIDED|80.0|-9.56|-1.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-1.07|-9.56|0.1133
91549099|NCT03858634|182980662|SUPERIORITY||LS mean difference|-16.7|STANDARD_ERROR_OF_MEAN|21.76||0.4997|TWO_SIDED|80.0|-52.29|18.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||18.98|-52.29|0.4997
91549100|NCT03858634|182980662|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|11.85||0.9919|TWO_SIDED|80.0|-15.83|15.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||15.59|-15.83|0.9919
91549101|NCT03858634|182980662|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|28.56||0.0891|TWO_SIDED|80.0|-143.03|-35.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-35.31|-143.03|0.0891
91549102|NCT03858634|182980662|SUPERIORITY||LS mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.1029|TWO_SIDED|80.0|-16.67|-2.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-2.12|-16.67|0.1029
91549103|NCT03858634|182980662|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|32.93||0.5538|TWO_SIDED|80.0|-75.82|32.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.05|-75.82|0.5538
91549104|NCT03858634|182980662|SUPERIORITY||LS mean difference|-11.9|STANDARD_ERROR_OF_MEAN|11.78||0.3252|TWO_SIDED|80.0|-27.51|3.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||3.73|-27.51|0.3252
91549105|NCT03858634|182980662|SUPERIORITY||LS mean difference|-93.8|STANDARD_ERROR_OF_MEAN|34.1||0.1106|TWO_SIDED|80.0|-158.11|-29.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-29.52|-158.11|0.1106
91549106|NCT03858634|182980662|SUPERIORITY||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|7.17||0.0123|TWO_SIDED|80.0|-29.48|-10.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-10.40|-29.48|0.0123
91549107|NCT03858634|182980662|SUPERIORITY||LS mean difference|-28.9|STANDARD_ERROR_OF_MEAN|35.86||0.4791|TWO_SIDED|80.0|-87.63|29.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.81|-87.63|0.4791
91549108|NCT03858634|182980662|SUPERIORITY||LS mean difference|-5.5|STANDARD_ERROR_OF_MEAN|12.66||0.6684|TWO_SIDED|80.0|-22.28|11.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||11.27|-22.28|0.6684
91549109|NCT03858634|182980662|SUPERIORITY||LS mean difference|-79.7|STANDARD_ERROR_OF_MEAN|26.28||0.0937|TWO_SIDED|80.0|-129.22|-30.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-30.13|-129.22|0.0937
91549110|NCT03858634|182980662|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|9.75||0.012|TWO_SIDED|80.0|-40.21|-14.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-14.27|-40.21|0.0120
91549111|NCT03858634|182980662|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|41.95||0.4927|TWO_SIDED|80.0|-101.39|36.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||36.02|-101.39|0.4927
91549112|NCT03858634|182980662|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|13.9||0.4409|TWO_SIDED|80.0|-29.35|7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||7.49|-29.35|0.4409
91549113|NCT03858634|182980662|SUPERIORITY||LS mean difference|-90.7|STANDARD_ERROR_OF_MEAN|34.58||0.1197|TWO_SIDED|80.0|-155.96|-25.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-25.54|-155.96|0.1197
91766302|NCT05736874|183421618|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.71|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.25|0.71|
91549114|NCT03858634|182980662|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|12.31||0.0102|TWO_SIDED|80.0|-51.68|-18.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANOVA|||Change at Week 5||-18.92|-51.68|0.0102
91549115|NCT03858634|182980662|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|38.77||0.4515|TWO_SIDED|80.0|-96.97|30.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.02|-96.97|0.4515
91549116|NCT03858634|182980662|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|14.56||0.7623|TWO_SIDED|80.0|-23.76|14.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||14.83|-23.76|0.7623
91549117|NCT03858634|182980662|SUPERIORITY||LS mean difference|-88.5|STANDARD_ERROR_OF_MEAN|34.57||0.1247|TWO_SIDED|80.0|-153.65|-23.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-23.29|-153.65|0.1247
91766303|NCT05736874|183421618|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.64|0.89|
91766304|NCT05736874|183421619|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.15|0.70|
91766305|NCT05736874|183421619|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.75|
91766306|NCT05736874|183421619|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.26|0.72|
91766307|NCT05736874|183421619|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.61|0.92|
91549118|NCT03858634|182980662|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|11.91||0.0053|TWO_SIDED|80.0|-53.59|-21.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-21.90|-53.59|0.0053
91549119|NCT03858634|182980662|SUPERIORITY||LS mean difference|-17.2|STANDARD_ERROR_OF_MEAN|43.23||0.7177|TWO_SIDED|80.0|-87.97|53.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||53.62|-87.97|0.7177
91549120|NCT03858634|182980662|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|14.35||0.6682|TWO_SIDED|80.0|-25.26|12.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||12.78|-25.26|0.6682
91549121|NCT03858634|182980662|SUPERIORITY||LS mean difference|-95.2|STANDARD_ERROR_OF_MEAN|29.16||0.0823|TWO_SIDED|80.0|-150.21|-40.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-40.24|-150.21|0.0823
91549122|NCT03858634|182980662|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|12.95||0.0087|TWO_SIDED|80.0|-55.38|-20.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.92|-55.38|0.0087
91549123|NCT03858634|182980662|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||31.76|-95.11|0.4734
91549124|NCT03858634|182980662|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-23.33|0.8130
91549125|NCT03858634|182980662|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-33.32|-150.60|0.0979
91549126|NCT03858634|182980662|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-19.61|-55.48|0.0122
91549127|NCT03858634|182980662|SUPERIORITY||LS mean difference|-32.1|STANDARD_ERROR_OF_MEAN|35.35||0.431|TWO_SIDED|80.0|-89.98|25.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||25.81|-89.98|0.4310
91549128|NCT03858634|182980662|SUPERIORITY||LS mean difference|-7.1|STANDARD_ERROR_OF_MEAN|15.22||0.6452|TWO_SIDED|80.0|-27.38|13.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||13.12|-27.38|0.6452
91549129|NCT03858634|182980662|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|37.02||0.1375|TWO_SIDED|80.0|-159.04|-19.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-19.44|-159.04|0.1375
91549130|NCT03858634|182980662|SUPERIORITY||LS mean difference|-39.6|STANDARD_ERROR_OF_MEAN|14.59||0.0143|TWO_SIDED|80.0|-58.97|-20.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-20.15|-58.97|0.0143
91549131|NCT03858634|182980662|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|36.4||0.5867|TWO_SIDED|80.0|-81.7|37.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||37.52|-81.70|0.5867
91549132|NCT03858634|182980662|SUPERIORITY||LS mean difference|6.1|STANDARD_ERROR_OF_MEAN|14.38||0.6745|TWO_SIDED|80.0|-12.99|25.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||25.27|-12.99|0.6745
91549133|NCT03858634|182980662|SUPERIORITY||LS mean difference|-85.6|STANDARD_ERROR_OF_MEAN|29.99||0.1039|TWO_SIDED|80.0|-142.18|-29.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-29.09|-142.18|0.1039
91549134|NCT03858634|182980662|SUPERIORITY||LS mean difference|-42.5|STANDARD_ERROR_OF_MEAN|15.12||0.0116|TWO_SIDED|80.0|-62.6|-22.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-22.36|-62.60|0.0116
91549135|NCT03858634|182980662|SUPERIORITY||LS mean difference|-23.1|STANDARD_ERROR_OF_MEAN|37.49||0.5807|TWO_SIDED|80.0|-84.55|38.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||38.26|-84.55|0.5807
91549136|NCT03858634|182980662|SUPERIORITY||LS mean difference|8.6|STANDARD_ERROR_OF_MEAN|15.16||0.5765|TWO_SIDED|80.0|-11.55|28.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||28.80|-11.55|0.5765
91549137|NCT03858634|182980662|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|28.36||0.0933|TWO_SIDED|80.0|-139.7|-32.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-32.75|-139.70|0.0933
91549138|NCT03858634|182980662|SUPERIORITY||LS mean difference|-39.3||||0.0173|TWO_SIDED|80.0|-59.29|-19.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-19.37|-59.29|0.0173
91549139|NCT03858634|182980662|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|38.36||0.5293|TWO_SIDED|80.0|-90.04|35.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||35.62|-90.04|0.5293
91549140|NCT03858634|182980662|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|15.12||0.9676|TWO_SIDED|80.0|-20.73|19.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||19.49|-20.73|0.9676
91549141|NCT03858634|182980662|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|23.38||0.0663|TWO_SIDED|80.0|-130.27|-42.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-42.11|-130.27|0.0663
91549142|NCT03858634|182980662|SUPERIORITY||LS mean difference|-37.4|STANDARD_ERROR_OF_MEAN|15.33||0.0252|TWO_SIDED|80.0|-57.81|-17.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-17.02|-57.81|0.0252
91549143|NCT03858634|182980662|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|40.81||0.6637|TWO_SIDED|80.0|-86.45|47.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||47.22|-86.45|0.6637
91549144|NCT03858634|182980662|SUPERIORITY||LS mean difference|-1.6|STANDARD_DEVIATION|15.35||0.9173|TWO_SIDED|80.0|-22.04|18.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||18.81|-22.04|0.9173
91549145|NCT03858634|182980662|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|26.55||0.0685|TWO_SIDED|80.0|-146.23|-46.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-46.10|-146.23|0.0685
91549146|NCT03858634|182980662|SUPERIORITY||LS mean difference|-39.7|STANDARD_ERROR_OF_MEAN|15.96||0.023|TWO_SIDED|80.0|-60.91|-18.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-18.44|-60.91|0.0230
91549147|NCT03858634|182980662|SUPERIORITY||LS mean difference|-19.1|STANDARD_ERROR_OF_MEAN|37.62||0.6471|TWO_SIDED|80.0|-80.69|42.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||42.54|-80.69|0.6471
91549148|NCT03858634|182980662|SUPERIORITY||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|15.52||0.8044|TWO_SIDED|80.0|-24.56|16.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||16.75|-24.56|0.8044
91549149|NCT03858634|182980662|SUPERIORITY||LS mean difference|-99.5|STANDARD_ERROR_OF_MEAN|28.71||0.0741|TWO_SIDED|80.0|-153.63|-45.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-45.37|-153.63|0.0741
91549150|NCT03858634|182980662|SUPERIORITY||LS mean difference|-39.9|STANDARD_ERROR_OF_MEAN|15.89||0.0219|TWO_SIDED|80.0|-61.0|-18.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-18.72|-61.00|0.0219
91549151|NCT03858634|182980662|SUPERIORITY||LS mean difference|-25.4|STANDARD_ERROR_OF_MEAN|37.15||0.5436|TWO_SIDED|80.0|-86.21|35.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||35.46|-86.21|0.5436
91549152|NCT03858634|182980662|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|16.13||0.9149|TWO_SIDED|80.0|-23.2|19.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||19.71|-23.20|0.9149
91549153|NCT03858634|182980662|SUPERIORITY||LS mean difference|-94.8|STANDARD_ERROR_OF_MEAN|25.34||0.0646|TWO_SIDED|80.0|-142.63|-47.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-47.05|-142.63|0.0646
91549154|NCT03858634|182980662|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.09||0.0611|TWO_SIDED|80.0|-56.89|-11.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-11.41|-56.89|0.0611
91549155|NCT03858634|182980662|SUPERIORITY||LS mean difference|-22.0|STANDARD_ERROR_OF_MEAN|38.28||0.606|TWO_SIDED|80.0|-84.68|40.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||40.71|-84.68|0.6060
91549156|NCT03858634|182980662|SUPERIORITY||LS mean difference|-6.9|STANDARD_ERROR_OF_MEAN|16.61||0.6823|TWO_SIDED|80.0|-29.0|15.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||15.18|-29.00|0.6823
91549157|NCT03858634|182980662|SUPERIORITY||LS mean difference|-99.7|STANDARD_ERROR_OF_MEAN|24.56||0.0556|TWO_SIDED|80.0|-146.02|-53.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-53.41|-146.02|0.0556
91549158|NCT03858634|182980662|SUPERIORITY||LS mean difference|-33.4|STANDARD_ERROR_OF_MEAN|16.99||0.0652|TWO_SIDED|80.0|-55.98|-10.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.76|-55.98|0.0652
91549159|NCT03858634|182980662|SUPERIORITY||LS mean difference|-26.3|STANDARD_ERROR_OF_MEAN|41.45||0.5714|TWO_SIDED|80.0|-94.14|41.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||41.62|-94.14|0.5714
91549160|NCT03858634|182980662|OTHER||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|16.82||0.5386|TWO_SIDED|80.0|-32.93|11.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||11.83|-32.93|0.5386
91549161|NCT03858634|182980662|SUPERIORITY||LS mean difference|-99.0|STANDARD_ERROR_OF_MEAN|21.41||0.0438|TWO_SIDED|80.0|-139.35|-58.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-58.60|-139.35|0.0438
91549162|NCT03858634|182980662|OTHER||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|19.66||0.1829|TWO_SIDED|80.0|-53.38|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-1.08|-53.38|0.1829
91549163|NCT03858634|182980662|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|37.59||0.5443|TWO_SIDED|80.0|-87.2|35.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||35.94|-87.20|0.5443
91549164|NCT03858634|182980662|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|18.43||0.6748|TWO_SIDED|80.0|-32.39|16.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.66|-32.39|0.6748
91549165|NCT03858634|182980662|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|16.97||0.0297|TWO_SIDED|80.0|-128.19|-64.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.19|-128.19|0.0297
91549166|NCT03858634|182980662|SUPERIORITY||LS mean difference|-27.0|STANDARD_ERROR_OF_MEAN|19.8||0.1899|TWO_SIDED|80.0|-53.33|-0.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-0.63|-53.33|0.1899
91549167|NCT03858634|182980664|SUPERIORITY||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|24.47||0.5763|TWO_SIDED|80.0|-55.37|24.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||24.78|-55.37|0.5763
91549168|NCT03858634|182980664|SUPERIORITY||LS mean difference|9.6|STANDARD_ERROR_OF_MEAN|14.66||0.5214|TWO_SIDED|80.0|-9.86|29.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||29.01|-9.86|0.5214
91549169|NCT03858634|182980664|SUPERIORITY||LS mean difference|-167.0|STANDARD_ERROR_OF_MEAN|105.28||0.2536|TWO_SIDED|80.0|-365.51|31.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||31.54|-365.51|0.2536
91549170|NCT03858634|182980664|SUPERIORITY||LS mean difference|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.067|TWO_SIDED|80.0|-18.2|-3.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-3.44|-18.20|0.0670
91549171|NCT03858634|182980664|SUPERIORITY||LS mean difference|-33.1|STANDARD_ERROR_OF_MEAN|34.98||0.4133|TWO_SIDED|80.0|-90.43|24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||24.15|-90.43|0.4133
91549172|NCT03858634|182980664|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|15.44||0.9305|TWO_SIDED|80.0|-21.83|19.11|||ANCOVA|||Change at Week 2||19.11|-21.83|0.9305
91549173|NCT03858634|182980664|SUPERIORITY||LS mean difference|-160.9|STANDARD_ERROR_OF_MEAN|132.98||0.3499|TWO_SIDED|80.0|-411.65|89.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||89.86|-411.65|0.3499
91549174|NCT03858634|182980664|SUPERIORITY||LS mean difference|-14.0|STANDARD_ERROR_OF_MEAN|9.55||0.1588|TWO_SIDED|80.0|-26.74|-1.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-1.33|-26.74|0.1588
91549175|NCT03858634|182980664|SUPERIORITY||LS mean difference|-40.6|STANDARD_ERROR_OF_MEAN|35.19||0.3319|TWO_SIDED|80.0|-98.26|17.0||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.00|-98.26|0.3319
91549176|NCT03858634|182980664|SUPERIORITY||LS mean difference|7.1|STANDARD_ERROR_OF_MEAN|19.39||0.7179|TWO_SIDED|80.0|-18.59|32.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.80|-18.59|0.7179
91549177|NCT03858634|182980664|SUPERIORITY||LS mean difference|-193.8|STANDARD_ERROR_OF_MEAN|112.17||0.2261|TWO_SIDED|80.0|-405.34|17.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.67|-405.34|0.2261
91549178|NCT03858634|182980664|SUPERIORITY||LS mean difference|-30.3|STANDARD_ERROR_OF_MEAN|10.88||0.0123|TWO_SIDED|80.0|-44.75|-15.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-15.80|-44.75|0.0123
91549179|NCT03858634|182980664|SUPERIORITY||LS mean difference|-54.0|STANDARD_ERROR_OF_MEAN|35.45||0.2253|TWO_SIDED|80.0|-112.02|4.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.09|-112.02|0.2253
91549180|NCT03858634|182980664|SUPERIORITY||LS mean difference|6.3|STANDARD_ERROR_OF_MEAN|16.9||0.7149|TWO_SIDED|80.0|-16.14|28.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||28.66|-16.14|0.7149
91549181|NCT03858634|182980664|SUPERIORITY||LS mean difference|-168.4|STANDARD_ERROR_OF_MEAN|109.12||0.2627|TWO_SIDED|80.0|-374.16|37.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||37.36|-374.16|0.2627
91549182|NCT03858634|182980664|SUPERIORITY||LS mean difference|-36.7|STANDARD_ERROR_OF_MEAN|11.38||0.0047|TWO_SIDED|80.0|-51.87|-21.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-21.60|-51.87|0.0047
91549183|NCT03858634|182980664|SUPERIORITY||LS mean difference|-66.1|STANDARD_ERROR_OF_MEAN|38.01||0.1803|TWO_SIDED|80.0|-128.37|-3.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-3.88|-128.37|0.1803
91766308|NCT05736874|183421620|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.28|0.81|
91766309|NCT05736874|183421620|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.6|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||0.99|0.60|
91549184|NCT03858634|182980664|SUPERIORITY||LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|17.34||0.7174|TWO_SIDED|80.0|-16.62|29.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||29.35|-16.62|0.7174
91549185|NCT03858634|182980664|SUPERIORITY||LS mean difference|-163.4|STANDARD_ERROR_OF_MEAN|103.47||0.2551|TWO_SIDED|80.0|-358.51|31.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.72|-358.51|0.2551
91549186|NCT03858634|182980664|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.36||0.0086|TWO_SIDED|80.0|-48.58|-18.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-18.36|-48.58|0.0086
91549187|NCT03858634|182980664|SUPERIORITY||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|40.16||0.2576|TWO_SIDED|80.0|-121.78|9.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.78|-121.78|0.2576
91549188|NCT03858634|182980664|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.09||0.9722|TWO_SIDED|80.0|-24.62|23.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||23.34|-24.62|0.9722
91549189|NCT03858634|182980664|SUPERIORITY||LS mean difference|-177.4|STANDARD_ERROR_OF_MEAN|95.72||0.2051|TWO_SIDED|80.0|-357.85|3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||3.13|-357.85|0.2051
91549190|NCT03858634|182980664|SUPERIORITY||LS mean difference|-42.0|STANDARD_ERROR_OF_MEAN|11.99||0.0025|TWO_SIDED|80.0|-57.98|-26.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-26.08|-57.98|0.0025
91549191|NCT03858634|182980664|SUPERIORITY||LS mean difference|-65.8|STANDARD_ERROR_OF_MEAN|33.78||0.1465|TWO_SIDED|80.0|-121.14|-10.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.50|-121.14|0.1465
91549192|NCT03858634|182980664|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|17.54||0.7734|TWO_SIDED|80.0|-18.13|28.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.37|-18.13|0.7734
91549193|NCT03858634|182980664|SUPERIORITY||LS mean difference|-175.5|STANDARD_ERROR_OF_MEAN|87.45||0.1826|TWO_SIDED|80.0|-340.37|-10.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.56|-340.37|0.1826
91549194|NCT03858634|182980664|SUPERIORITY||LS mean difference|-39.2|STANDARD_ERROR_OF_MEAN|13.71||0.0105|TWO_SIDED|80.0|-57.4|-20.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.93|-57.40|0.0105
91549195|NCT03858634|182980664|SUPERIORITY||LS mean difference|-53.7|STANDARD_ERROR_OF_MEAN|40.17||0.2737|TWO_SIDED|80.0|-119.49|12.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.09|-119.49|0.2737
91549196|NCT03858634|182980664|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|17.77||0.8692|TWO_SIDED|80.0|-20.59|26.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||26.52|-20.59|0.8692
91549197|NCT03858634|182980664|SUPERIORITY||LS mean difference|-163.0|STANDARD_ERROR_OF_MEAN|89.64||0.2106|TWO_SIDED|80.0|-332.06|5.99||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||5.99|-332.06|0.2106
91549198|NCT03858634|182980664|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|14.67||0.006|TWO_SIDED|80.0|-65.19|-26.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-26.14|-65.19|0.0060
91549199|NCT03858634|182980664|SUPERIORITY||LS mean difference|-62.3|STANDARD_ERROR_OF_MEAN|36.12||0.1831|TWO_SIDED|80.0|-121.44|-3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.13|-121.44|0.1831
91549200|NCT03858634|182980664|SUPERIORITY||LS mean difference|21.5|STANDARD_ERROR_OF_MEAN|16.39||0.2061|TWO_SIDED|80.0|-0.31|43.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||43.30|-0.31|0.2061
91549201|NCT03858634|182980664|SUPERIORITY||LS mean difference|-161.4|STANDARD_ERROR_OF_MEAN|87.75||0.2073|TWO_SIDED|80.0|-326.83|4.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||4.12|-326.83|0.2073
91549202|NCT03858634|182980664|SUPERIORITY||LS mean difference|-34.4|STANDARD_ERROR_OF_MEAN|15.19||0.0371|TWO_SIDED|80.0|-54.62|-14.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-14.10|-54.62|0.0371
91766310|NCT05736874|183421620|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.23|0.74|
91766311|NCT05736874|183421620|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.50|0.89|
91766312|NCT05736874|183421621|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.06|0.69|
91549203|NCT03858634|182980664|SUPERIORITY||LS mean difference|-55.2|STANDARD_ERROR_OF_MEAN|37.72||0.2393|TWO_SIDED|80.0|-117.01|6.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||6.54|-117.01|0.2393
91549204|NCT03858634|182980664|SUPERIORITY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|19.01||0.9019|TWO_SIDED|80.0|-22.91|27.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||27.67|-22.91|0.9019
91549205|NCT03858634|182980664|SUPERIORITY||LS mean difference|-149.2|STANDARD_ERROR_OF_MEAN|81.97||0.2103|TWO_SIDED|80.0|-303.77|5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||5.35|-303.77|0.2103
91549206|NCT03858634|182980664|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|15.2||0.1634|TWO_SIDED|80.0|-42.4|-1.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-1.88|-42.40|0.1634
91549207|NCT03858634|182980664|SUPERIORITY||LS mean difference|-48.6|STANDARD_ERROR_OF_MEAN|36.28||0.2727|TWO_SIDED|80.0|-108.04|10.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||10.80|-108.04|0.2727
91549208|NCT03858634|182980664|SUPERIORITY||LS mean difference|-9.6|STANDARD_ERROR_OF_MEAN|17.29||0.5839|TWO_SIDED|80.0|-32.65|13.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||13.36|-32.65|0.5839
91549209|NCT03858634|182980664|SUPERIORITY||LS mean difference|-167.8|STANDARD_ERROR_OF_MEAN|76.58||0.1597|TWO_SIDED|80.0|-312.25|-23.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-23.45|-312.25|0.1597
91549210|NCT03858634|182980664|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|16.27||0.1138|TWO_SIDED|80.0|-48.81|-5.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.43|-48.81|0.1138
91549211|NCT03858634|182980664|SUPERIORITY||LS mean difference|-62.0|STANDARD_ERROR_OF_MEAN|24.93||0.0888|TWO_SIDED|80.0|-102.78|-21.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-21.13|-102.78|0.0888
91549212|NCT03858634|182980664|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.19||0.9741|TWO_SIDED|80.0|-24.79|23.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||23.60|-24.79|0.9741
91549213|NCT03858634|182980664|SUPERIORITY||LS mean difference|-159.2|STANDARD_ERROR_OF_MEAN|65.42||0.1354|TWO_SIDED|80.0|-282.59|-35.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-35.87|-282.59|0.1354
91549214|NCT03858634|182980664|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|17.21||0.1425|TWO_SIDED|80.0|-49.41|-3.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-3.52|-49.41|0.1425
91549215|NCT03858634|182980664|SUPERIORITY||LS mean difference|-54.6|STANDARD_ERROR_OF_MEAN|26.61||0.1326|TWO_SIDED|80.0|-98.18|-11.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-11.01|-98.18|0.1326
91549216|NCT03858634|182980664|OTHER||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|20.87||0.8433|TWO_SIDED|80.0|-31.95|23.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||23.58|-31.95|0.8433
91549217|NCT03858634|182980664|SUPERIORITY||LS mean difference|-130.8|STANDARD_ERROR_OF_MEAN|38.5||0.0768|TWO_SIDED|80.0|-203.39|-58.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-58.19|-203.39|0.0768
91549218|NCT03858634|182980664|SUPERIORITY||LS mean difference|-18.6|STANDARD_ERROR_OF_MEAN|18.69||0.3341|TWO_SIDED|80.0|-43.49|6.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||6.34|-43.49|0.3341
91549219|NCT03858634|182980666|SUPERIORITY||LS mean difference|-40.9|STANDARD_ERROR_OF_MEAN|40.82||0.4995|TWO_SIDED|80.0|-166.52|84.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||84.74|-166.52|0.4995
91549220|NCT03858634|182980666|SUPERIORITY||LS mean difference|-3.7|STANDARD_ERROR_OF_MEAN|9.59||0.7071|TWO_SIDED|80.0|-16.37|9.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||9.06|-16.37|0.7071
91549221|NCT03858634|182980666|SUPERIORITY||LS mean difference|-52.5|STANDARD_ERROR_OF_MEAN|9.39||0.0305|TWO_SIDED|80.0|-70.18|-34.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-34.77|-70.18|0.0305
91549222|NCT03858634|182980666|SUPERIORITY||LS mean difference|-6.6|STANDARD_ERROR_OF_MEAN|9.33||0.4884|TWO_SIDED|80.0|-19.01|5.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||5.81|-19.01|0.4884
91549223|NCT03858634|182980666|SUPERIORITY||LS mean difference|-45.3|STANDARD_ERROR_OF_MEAN|31.63||0.2885|TWO_SIDED|80.0|-104.93|14.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||14.35|-104.93|0.2885
91549224|NCT03858634|182980666|SUPERIORITY||LS mean difference|5.2|STANDARD_ERROR_OF_MEAN|11.24||0.6505|TWO_SIDED|80.0|-9.73|20.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||20.06|-9.73|0.6505
91549225|NCT03858634|182980666|SUPERIORITY||LS mean difference|-72.1|STANDARD_ERROR_OF_MEAN|5.72||0.0062|TWO_SIDED|80.0|-82.91|-61.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-61.34|-82.91|0.0062
91549226|NCT03858634|182980666|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|9.62||0.0571|TWO_SIDED|80.0|-32.34|-6.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.76|-32.34|0.0571
91549227|NCT03858634|182980666|SUPERIORITY||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Change at Week 6||||
91549228|NCT03858634|182980666|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.65||0.6927|TWO_SIDED|80.0|-18.38|9.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.84|-18.38|0.6927
91549229|NCT03858634|182980666|SUPERIORITY||LS mean difference|-65.6|STANDARD_ERROR_OF_MEAN|4.08||0.0038|TWO_SIDED|80.0|-73.33|-57.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-57.94|-73.33|0.0038
91549230|NCT03858634|182980666|SUPERIORITY||LS mean difference|-17.4|STANDARD_ERROR_OF_MEAN|9.82||0.094|TWO_SIDED|80.0|-30.43|-4.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-4.30|-30.43|0.0940
91549231|NCT03858634|182980666|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|19.73||0.1694|TWO_SIDED|80.0|-133.1|-11.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-11.65|-133.10|0.1694
91549232|NCT03858634|182980666|SUPERIORITY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|10.07||0.7811|TWO_SIDED|80.0|-10.5|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-10.50|0.7811
91549233|NCT03858634|182980666|SUPERIORITY||LS mean difference|-68.2|STANDARD_ERROR_OF_MEAN|2.28||0.0011|TWO_SIDED|80.0|-72.51|-63.91||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-63.91|-72.51|0.0011
91549234|NCT03858634|182980666|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|9.52||0.0245|TWO_SIDED|80.0|-36.02|-10.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-10.70|-36.02|0.0245
91549235|NCT03858634|182980666|SUPERIORITY||LS mean difference|-61.8|STANDARD_ERROR_OF_MEAN|5.87||0.0603|TWO_SIDED|80.0|-79.88|-43.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-43.74|-79.88|0.0603
91549236|NCT03858634|182980666|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.89||0.4365|TWO_SIDED|80.0|-5.29|21.04||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||21.04|-5.29|0.4365
91549237|NCT03858634|182980666|SUPERIORITY||LS mean difference|-68.7|STANDARD_ERROR_OF_MEAN|10.3||0.0218|TWO_SIDED|80.0|-88.11|-49.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-49.26|-88.11|0.0218
91549238|NCT03858634|182980666|SUPERIORITY||LS mean difference|-19.5|STANDARD_ERROR_OF_MEAN|12.07||0.1238|TWO_SIDED|80.0|-35.65|-3.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.45|-35.65|0.1238
91549239|NCT03858634|182980666|SUPERIORITY||LS mean difference|-54.8|STANDARD_ERROR_OF_MEAN|23.38||0.1437|TWO_SIDED|80.0|-98.88|-10.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.72|-98.88|0.1437
91549240|NCT03858634|182980666|SUPERIORITY||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|10.14||0.9279|TWO_SIDED|80.0|-12.56|14.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||14.43|-12.56|0.9279
91549241|NCT03858634|182980666|SUPERIORITY||LS mean difference|-59.5|STANDARD_ERROR_OF_MEAN|9.67||0.0254|TWO_SIDED|80.0|-77.69|-41.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-41.24|-77.69|0.0254
91549242|NCT03858634|182980666|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|10.8||0.0994|TWO_SIDED|80.0|-33.23|-4.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-4.43|-33.23|0.0994
91549243|NCT03858634|182980666|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|39.36||0.3656|TWO_SIDED|80.0|-119.9|28.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||28.54|-119.90|0.3656
91549244|NCT03858634|182980666|SUPERIORITY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|8.92||0.7465|TWO_SIDED|80.0|-14.79|8.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||8.94|-14.79|0.7465
91549245|NCT03858634|182980666|SUPERIORITY||LS mean difference|-82.3|STANDARD_ERROR_OF_MEAN|10.3||0.0153|TWO_SIDED|80.0|-101.75|-62.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-62.90|-101.75|0.0153
91549246|NCT03858634|182980666|SUPERIORITY||LS mean difference|-16.6|STANDARD_ERROR_OF_MEAN|12.97||0.2184|TWO_SIDED|80.0|-33.88|0.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||0.72|-33.88|0.2184
91549247|NCT03858634|182980666|SUPERIORITY||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|25.78||0.7726|TWO_SIDED|80.0|-50.37|34.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||34.07|-50.37|0.7726
91549248|NCT03858634|182980666|SUPERIORITY||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|12.66||0.476|TWO_SIDED|80.0|-26.07|7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||7.63|-26.07|0.4760
91549249|NCT03858634|182980666|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-64.87|-99.26|0.0121
91549250|NCT03858634|182980666|SUPERIORITY||LS mean difference|-13.0|STANDARD_ERROR_OF_MEAN|13.06||0.3329|TWO_SIDED|80.0|-30.43|4.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||4.40|-30.43|0.3329
91549251|NCT03858634|182980666|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|28.46||0.9564|TWO_SIDED|80.0|-48.31|44.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||44.92|-48.31|0.9564
91549252|NCT03858634|182980666|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|13.49||0.5661|TWO_SIDED|80.0|-25.84|10.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||10.06|-25.84|0.5661
91549253|NCT03858634|182980666|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.87|-99.26|0.0121
91549254|NCT03858634|182980666|SUPERIORITY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|13.7||0.4275|TWO_SIDED|80.0|-29.4|7.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||7.13|-29.40|0.4275
91549255|NCT03858634|182980671|SUPERIORITY||LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|40.54||0.5403|TWO_SIDED|80.0|-94.32|38.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.46|-94.32|0.5403
91549256|NCT03858634|182980671|SUPERIORITY||LS mean difference|376.1|STANDARD_ERROR_OF_MEAN|631.83||0.5587|TWO_SIDED|80.0|-462.83|1214.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1214.97|-462.83|0.5587
91549257|NCT03858634|182980671|SUPERIORITY||LS mean difference|-67.7|STANDARD_ERROR_OF_MEAN|72.99||0.4516|TWO_SIDED|80.0|-205.33|69.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||69.93|-205.33|0.4516
91549258|NCT03858634|182980671|SUPERIORITY||LS mean difference|-12.5|STANDARD_ERROR_OF_MEAN|9.5||0.2052|TWO_SIDED|80.0|-25.13|0.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||0.15|-25.13|0.2052
91549259|NCT03858634|182980671|SUPERIORITY||LS mean difference|-59.4|STANDARD_ERROR_OF_MEAN|38.89||0.224|TWO_SIDED|80.0|-123.09|4.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||4.28|-123.09|0.2240
91549260|NCT03858634|182980671|SUPERIORITY||LS mean difference|39.5|STANDARD_ERROR_OF_MEAN|48.33||0.4242|TWO_SIDED|80.0|-24.7|103.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||103.65|-24.70|0.4242
91766313|NCT05736874|183421621|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.82|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.30|0.82|
91549261|NCT03858634|182980671|SUPERIORITY||LS mean difference|-77.2|STANDARD_ERROR_OF_MEAN|78.61||0.4295|TWO_SIDED|80.0|-225.44|71.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||71.01|-225.44|0.4295
91549262|NCT03858634|182980671|SUPERIORITY||LS mean difference|-18.7|STANDARD_ERROR_OF_MEAN|14.97||0.2272|TWO_SIDED|80.0|-38.64|1.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||1.20|-38.64|0.2272
91549263|NCT03858634|182980671|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|48.9||0.3416|TWO_SIDED|80.0|-135.23|24.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.95|-135.23|0.3416
91549264|NCT03858634|182980671|SUPERIORITY||LS mean difference|57.6|STANDARD_ERROR_OF_MEAN|69.75||0.4192|TWO_SIDED|80.0|-35.02|150.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||150.19|-35.02|0.4192
91549265|NCT03858634|182980671|SUPERIORITY||LS mean difference|-66.8|STANDARD_ERROR_OF_MEAN|87.42||0.5245|TWO_SIDED|80.0|-231.66|98.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||98.02|-231.66|0.5245
91549266|NCT03858634|182980671|SUPERIORITY||LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|13.31||0.1988|TWO_SIDED|80.0|-35.47|-0.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-0.05|-35.47|0.1988
91549267|NCT03858634|182980671|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|56.11||0.3054|TWO_SIDED|80.0|-161.08|22.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.72|-161.08|0.3054
91549268|NCT03858634|182980671|SUPERIORITY||LS mean difference|229.4|STANDARD_ERROR_OF_MEAN|377.23||0.5504|TWO_SIDED|80.0|-271.51|730.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||730.22|-271.51|0.5504
91549269|NCT03858634|182980671|SUPERIORITY||LS mean difference|-71.2|STANDARD_ERROR_OF_MEAN|76.27||0.4493|TWO_SIDED|80.0|-214.96|72.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||72.65|-214.96|0.4493
91549270|NCT03858634|182980671|SUPERIORITY||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|20.63||0.0665|TWO_SIDED|80.0|-67.74|-12.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-12.85|-67.74|0.0665
91549271|NCT03858634|182980671|SUPERIORITY||LS mean difference|-78.7|STANDARD_ERROR_OF_MEAN|54.04||0.2411|TWO_SIDED|80.0|-167.25|9.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||9.75|-167.25|0.2411
91549272|NCT03858634|182980671|SUPERIORITY||LS mean difference|60.8|STANDARD_ERROR_OF_MEAN|79.3||0.4528|TWO_SIDED|80.0|-44.51|166.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||166.08|-44.51|0.4528
91549273|NCT03858634|182980671|SUPERIORITY||LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|75.46||0.6381|TWO_SIDED|80.0|-183.72|100.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||100.85|-183.72|0.6381
91549274|NCT03858634|182980671|SUPERIORITY||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|17.22||0.0837|TWO_SIDED|80.0|-54.44|-8.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.62|-54.44|0.0837
91549275|NCT03858634|182980671|SUPERIORITY||LS mean difference|-74.7|STANDARD_ERROR_OF_MEAN|66.45||0.3428|TWO_SIDED|80.0|-183.53|34.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||34.13|-183.53|0.3428
91549276|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|21.8|STANDARD_ERROR_OF_MEAN|22.93||0.3533|TWO_SIDED|80.0|-8.63|52.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||52.27|-8.63|0.3533
91549277|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-63.9|STANDARD_ERROR_OF_MEAN|56.53||0.3755|TWO_SIDED|80.0|-170.51|42.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||42.66|-170.51|0.3755
91766314|NCT05736874|183421621|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.32|0.80|
91549278|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|15.6||0.0268|TWO_SIDED|80.0|-58.39|-16.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.87|-58.39|0.0268
91549279|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-79.5|STANDARD_ERROR_OF_MEAN|43.79||0.1672|TWO_SIDED|80.0|-151.2|-7.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-7.75|-151.20|0.1672
91549280|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|43.7|STANDARD_ERROR_OF_MEAN|45.81||0.3518|TWO_SIDED|80.0|-17.09|104.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.55|-17.09|0.3518
91549281|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-68.7|STANDARD_ERROR_OF_MEAN|49.22||0.2974|TWO_SIDED|80.0|-161.52|24.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||24.09|-161.52|0.2974
91549282|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|18.6||0.0555|TWO_SIDED|80.0|-62.83|-13.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.33|-62.83|0.0555
91549283|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-78.3|STANDARD_ERROR_OF_MEAN|56.72||0.2614|TWO_SIDED|80.0|-171.17|14.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||14.62|-171.17|0.2614
91549284|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|31.7|STANDARD_ERROR_OF_MEAN|37.89||0.4134|TWO_SIDED|80.0|-18.62|81.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||81.98|-18.62|0.4134
91549285|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-69.6|STANDARD_ERROR_OF_MEAN|44.99||0.262|TWO_SIDED|80.0|-154.44|15.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||15.24|-154.44|0.2620
91549286|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|16.7||0.0269|TWO_SIDED|80.0|-62.46|-18.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-18.02|-62.46|0.0269
91549287|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-81.2|STANDARD_ERROR_OF_MEAN|45.32||0.1709|TWO_SIDED|80.0|-155.46|-7.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.02|-155.46|0.1709
91549288|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|42.9|STANDARD_ERROR_OF_MEAN|12.98||0.0042|TWO_SIDED|80.0|25.61|60.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||60.22|25.61|0.0042
91549289|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|47.22||0.3772|TWO_SIDED|80.0|-142.19|35.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||35.88|-142.19|0.3772
91549290|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-28.3|STANDARD_ERROR_OF_MEAN|15.54||0.0857|TWO_SIDED|80.0|-49.06|-7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.63|-49.06|0.0857
91549291|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-77.3|STANDARD_ERROR_OF_MEAN|26.34||0.0607|TWO_SIDED|80.0|-120.48|-34.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-34.20|-120.48|0.0607
91549292|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|88.8|STANDARD_ERROR_OF_MEAN|124.79||0.4862|TWO_SIDED|80.0|-77.57|255.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||255.22|-77.57|0.4862
91549293|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|49.73||0.3968|TWO_SIDED|80.0|-146.96|40.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.58|-146.96|0.3968
91549294|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|16.57||0.1624|TWO_SIDED|80.0|-46.31|-2.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-2.11|-46.31|0.1624
91549295|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-76.8|STANDARD_ERROR_OF_MEAN|37.75||0.1349|TWO_SIDED|80.0|-138.58|-14.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-14.93|-138.58|0.1349
91549296|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|45.5|STANDARD_ERROR_OF_MEAN|21.81||0.0525|TWO_SIDED|80.0|16.38|74.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||74.56|16.38|0.0525
91549297|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-76.6|STANDARD_ERROR_OF_MEAN|50.98||0.2719|TWO_SIDED|80.0|-172.71|19.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||19.55|-172.71|0.2719
91549298|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|17.39||0.0957|TWO_SIDED|80.0|-53.86|-7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-7.49|-53.86|0.0957
91549299|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-79.8|STANDARD_ERROR_OF_MEAN|32.98||0.0942|TWO_SIDED|80.0|-133.83|-25.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-25.78|-133.83|0.0942
91549300|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|34.6|STANDARD_ERROR_OF_MEAN|23.6||0.1606|TWO_SIDED|80.0|3.16|66.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||66.09|3.16|0.1606
91549301|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-77.0|STANDARD_ERROR_OF_MEAN|42.2||0.2096|TWO_SIDED|80.0|-156.58|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||2.58|-156.58|0.2096
91549302|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|18.32||0.1279|TWO_SIDED|80.0|-53.74|-4.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-4.89|-53.74|0.1279
91549303|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-75.0|STANDARD_ERROR_OF_MEAN|23.17||0.0479|TWO_SIDED|80.0|-112.96|-37.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-37.08|-112.96|0.0479
91549304|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|32.8|STANDARD_ERROR_OF_MEAN|22.91||0.17|TWO_SIDED|80.0|2.28|63.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||63.37|2.28|0.1700
91549305|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-80.1|STANDARD_ERROR_OF_MEAN|29.67||0.1142|TWO_SIDED|80.0|-136.03|-24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-24.15|-136.03|0.1142
91549306|NCT03858634|182980671|SUPERIORITY||LS Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|20.82||0.398|TWO_SIDED|80.0|-45.8|9.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.71|-45.80|0.3980
91766315|NCT05736874|183421621|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
91766316|NCT05736874|183421622|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.62|
91549307|NCT03858634|182980673|SUPERIORITY||LS mean difference|-13.2|STANDARD_ERROR_OF_MEAN|17.11||0.4979|TWO_SIDED|80.0|-41.17|14.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||14.86|-41.17|0.4979
91549308|NCT03858634|182980673|SUPERIORITY||LS mean difference|21.7|STANDARD_ERROR_OF_MEAN|12.88||0.1079|TWO_SIDED|80.0|4.63|38.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.83|4.63|0.1079
91549309|NCT03858634|182980673|SUPERIORITY||LS mean difference|-35.6|STANDARD_ERROR_OF_MEAN|41.7||0.4837|TWO_SIDED|80.0|-114.19|43.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||43.07|-114.19|0.4837
91549310|NCT03858634|182980673|SUPERIORITY||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|4.14||0.0208|TWO_SIDED|80.0|-15.99|-4.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-4.98|-15.99|0.0208
91549311|NCT03858634|182980673|SUPERIORITY||LS mean difference|-16.2|STANDARD_ERROR_OF_MEAN|23.54||0.5413|TWO_SIDED|80.0|-54.74|22.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||22.38|-54.74|0.5413
91549312|NCT03858634|182980673|SUPERIORITY||LS mean difference|17.5|STANDARD_ERROR_OF_MEAN|12.22||0.1683|TWO_SIDED|80.0|1.28|33.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||33.74|1.28|0.1683
91549313|NCT03858634|182980673|SUPERIORITY||LS mean difference|-58.8|STANDARD_ERROR_OF_MEAN|54.45||0.3933|TWO_SIDED|80.0|-161.43|43.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||43.89|-161.43|0.3933
91549314|NCT03858634|182980673|SUPERIORITY||LS mean difference|-5.7|STANDARD_ERROR_OF_MEAN|6.25||0.3705|TWO_SIDED|80.0|-14.06|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.58|-14.06|0.3705
91549315|NCT03858634|182980673|SUPERIORITY||LS mean difference|-23.0|STANDARD_ERROR_OF_MEAN|35.63||0.5644|TWO_SIDED|80.0|-81.36|35.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||35.34|-81.36|0.5644
91549316|NCT03858634|182980673|SUPERIORITY||LS mean difference|6.6|STANDARD_ERROR_OF_MEAN|13.82||0.6384|TWO_SIDED|80.0|-11.75|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.94|-11.75|0.6384
91549317|NCT03858634|182980673|SUPERIORITY||LS mean difference|-58.6|STANDARD_ERROR_OF_MEAN|58.62||0.4229|TWO_SIDED|80.0|-169.13|51.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||51.95|-169.13|0.4229
91549318|NCT03858634|182980673|SUPERIORITY||LS mean difference|-16.3|STANDARD_ERROR_OF_MEAN|11.38||0.1688|TWO_SIDED|80.0|-31.47|-1.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.18|-31.47|0.1688
91549319|NCT03858634|182980673|SUPERIORITY||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|28.11||0.1243|TWO_SIDED|80.0|-105.59|-13.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-13.53|-105.59|0.1243
91549320|NCT03858634|182980673|SUPERIORITY||LS mean difference|6.9|STANDARD_ERROR_OF_MEAN|16.79||0.6841|TWO_SIDED|80.0|-15.35|29.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.22|-15.35|0.6841
91549321|NCT03858634|182980673|SUPERIORITY||LS mean difference|-53.4|STANDARD_ERROR_OF_MEAN|49.83||0.3963|TWO_SIDED|80.0|-147.31|40.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||40.59|-147.31|0.3963
91549322|NCT03858634|182980673|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|11.85||0.0571|TWO_SIDED|80.0|-39.85|-8.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-8.32|-39.85|0.0571
91549323|NCT03858634|182980673|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|40.32||0.4457|TWO_SIDED|80.0|-101.32|30.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||30.73|-101.32|0.4457
91549324|NCT03858634|182980673|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|17.99||0.8075|TWO_SIDED|80.0|-19.44|28.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||28.32|-19.44|0.8075
91549325|NCT03858634|182980673|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|55.75||0.4093|TWO_SIDED|80.0|-162.84|47.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||47.40|-162.84|0.4093
91549326|NCT03858634|182980673|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|13.4||0.0543|TWO_SIDED|80.0|-45.42|-9.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-9.76|-45.42|0.0543
91549327|NCT03858634|182980673|SUPERIORITY||LS mean difference|-31.0|STANDARD_ERROR_OF_MEAN|37.75||0.4711|TWO_SIDED|80.0|-92.88|30.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.78|-92.88|0.4711
91549328|NCT03858634|182980673|SUPERIORITY||LS mean difference|13.0|STANDARD_ERROR_OF_MEAN|14.89||0.3925|TWO_SIDED|80.0|-6.74|32.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||32.79|-6.74|0.3925
91549329|NCT03858634|182980673|SUPERIORITY||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|61.24||0.5095|TWO_SIDED|80.0|-164.22|66.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||66.72|-164.22|0.5095
91549330|NCT03858634|182980673|SUPERIORITY||LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|13.22||0.0199|TWO_SIDED|80.0|-51.35|-16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.18|-51.35|0.0199
91549331|NCT03858634|182980673|SUPERIORITY||LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|34.48||0.3029|TWO_SIDED|80.0|-99.26|13.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||13.69|-99.26|0.3029
91549332|NCT03858634|182980673|SUPERIORITY||LS mean difference|10.9|STANDARD_ERROR_OF_MEAN|12.97||0.4094|TWO_SIDED|80.0|-6.28|28.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.16|-6.28|0.4094
91766317|NCT05736874|183421622|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.18|0.78|
91766318|NCT05736874|183421622|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.12|0.74|
91549333|NCT03858634|182980673|SUPERIORITY||LS mean difference|-49.8|STANDARD_ERROR_OF_MEAN|58.25||0.4828|TWO_SIDED|80.0|-159.63|60.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||60.05|-159.63|0.4828
91549334|NCT03858634|182980673|SUPERIORITY||LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|14.66||0.0383|TWO_SIDED|80.0|-52.26|-13.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.26|-52.26|0.0383
91549335|NCT03858634|182980673|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|37.1||0.5322|TWO_SIDED|80.0|-86.66|34.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||34.65|-86.66|0.5322
91549336|NCT03858634|182980673|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|13.71||0.6577|TWO_SIDED|80.0|-24.38|12.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.03|-24.38|0.6577
91549337|NCT03858634|182980673|SUPERIORITY||LS mean difference|-38.3|STANDARD_ERROR_OF_MEAN|67.21||0.6259|TWO_SIDED|80.0|-165.08|88.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||88.40|-165.08|0.6259
91766319|NCT05736874|183421622|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.02|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.56|1.02|
91766320|NCT05736874|183421623|SUPERIORITY||Difference in model estimate time unwell|-0.1|||||TWO_SIDED|95.0|-0.45|0.26|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.26|-0.45|
91549338|NCT03858634|182980673|SUPERIORITY||LS mean difference|-35.7|STANDARD_ERROR_OF_MEAN|15.27||0.0312|TWO_SIDED|80.0|-56.01|-15.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.38|-56.01|0.0312
91549339|NCT03858634|182980673|SUPERIORITY||LS mean difference|-108.3|STANDARD_ERROR_OF_MEAN|18.73||0.0103|TWO_SIDED|80.0|-138.97|-77.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-77.61|-138.97|0.0103
91549340|NCT03858634|182980673|SUPERIORITY||LS mean difference|10.0|STANDARD_ERROR_OF_MEAN|12.43||0.433|TWO_SIDED|80.0|-6.59|26.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||26.56|-6.59|0.4330
91549341|NCT03858634|182980673|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|64.23||0.6165|TWO_SIDED|80.0|-158.82|83.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||83.39|-158.82|0.6165
91549342|NCT03858634|182980673|SUPERIORITY||LS mean difference|-32.0|STANDARD_ERROR_OF_MEAN|15.13||0.0488|TWO_SIDED|80.0|-52.11|-11.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-11.84|-52.11|0.0488
91549343|NCT03858634|182980673|SUPERIORITY||LS mean difference|-19.2|STANDARD_ERROR_OF_MEAN|39.9||0.6636|TWO_SIDED|80.0|-84.53|46.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||46.16|-84.53|0.6636
91549344|NCT03858634|182980673|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|11.75||0.0583|TWO_SIDED|80.0|8.18|39.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||39.52|8.18|0.0583
91549345|NCT03858634|182980673|SUPERIORITY||LS mean difference|-45.1|STANDARD_ERROR_OF_MEAN|54.87||0.4975|TWO_SIDED|80.0|-148.55|58.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||58.36|-148.55|0.4975
91549346|NCT03858634|182980673|SUPERIORITY||LS mean difference|-30.5|STANDARD_ERROR_OF_MEAN|15.54||0.0653|TWO_SIDED|80.0|-51.17|-9.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-9.82|-51.17|0.0653
91549347|NCT03858634|182980673|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|43.98||0.6316|TWO_SIDED|80.0|-95.42|48.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||48.62|-95.42|0.6316
91549348|NCT03858634|182980673|SUPERIORITY||LS mean difference|26.6|STANDARD_ERROR_OF_MEAN|14.68||0.0874|TWO_SIDED|80.0|7.05|46.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||46.18|7.05|0.0874
91549349|NCT03858634|182980673|SUPERIORITY||LS mean difference|-45.0|STANDARD_ERROR_OF_MEAN|50.39||0.4662|TWO_SIDED|80.0|-139.99|50.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||50.03|-139.99|0.4662
91549350|NCT03858634|182980673|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|15.12||0.1073|TWO_SIDED|80.0|-45.76|-5.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-5.51|-45.76|0.1073
91549351|NCT03858634|182980673|SUPERIORITY||LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|42.31||0.6197|TWO_SIDED|80.0|-92.62|45.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||45.96|-92.62|0.6197
91549352|NCT03858634|182980673|SUPERIORITY||LS mean difference|20.6|STANDARD_ERROR_OF_MEAN|14.97||0.1868|TWO_SIDED|80.0|0.63|40.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.55|0.63|0.1868
91766321|NCT05736874|183421624|SUPERIORITY||Difference in model estimated means|0.13|||||TWO_SIDED|95.0|-0.28|0.58|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.58|-0.28|
91766322|NCT02981368|183421642|SUPERIORITY|||||||0.1097|||||||Fisher Exact|||Tissue Site: Bone||||0.1097
91766323|NCT02981368|183421642|SUPERIORITY|||||||0.1087|||||||Fisher Exact|||Tissue Site: Bone||||0.1087
91549353|NCT03858634|182980673|SUPERIORITY||LS mean difference|-55.0|STANDARD_ERROR_OF_MEAN|43.32||0.3321|TWO_SIDED|80.0|-136.65|26.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||26.71|-136.65|0.3321
91549354|NCT03858634|182980673|SUPERIORITY||LS mean difference|-24.8|STANDARD_ERROR_OF_MEAN|15.67||0.131|TWO_SIDED|80.0|-45.64|-3.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-3.95|-45.64|0.1310
91549355|NCT03858634|182980673|SUPERIORITY||LS mean difference|-12.0|STANDARD_ERROR_OF_MEAN|46.49||0.8128|TWO_SIDED|80.0|-88.15|64.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||64.13|-88.15|0.8128
91549356|NCT03858634|182980673|SUPERIORITY||LS mean difference|24.7|STANDARD_ERROR_OF_MEAN|14.23||0.1004|TWO_SIDED|80.0|5.75|43.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||43.69|5.75|0.1004
91549357|NCT03858634|182980673|SUPERIORITY||LS mean difference|-62.8|STANDARD_ERROR_OF_MEAN|44.81||0.2962|TWO_SIDED|80.0|-147.28|21.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||21.71|-147.28|0.2962
91549358|NCT03858634|182980673|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|16.4||0.1236|TWO_SIDED|80.0|-48.31|-4.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-4.67|-48.31|0.1236
91549359|NCT03858634|182980673|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|45.55||0.9276|TWO_SIDED|80.0|-79.1|70.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||70.11|-79.10|0.9276
91549360|NCT03858634|182980673|SUPERIORITY||LS mean difference|19.5|STANDARD_ERROR_OF_MEAN|13.46||0.1657|TWO_SIDED|80.0|1.55|37.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||37.45|1.55|0.1657
91549361|NCT03858634|182980673|SUPERIORITY||LS mean difference|-58.4|STANDARD_ERROR_OF_MEAN|47.8||0.3461|TWO_SIDED|80.0|-148.54|31.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||31.71|-148.54|0.3461
91549362|NCT03858634|182980673|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|16.51||0.1118|TWO_SIDED|80.0|-49.58|-5.64||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.64|-49.58|0.1118
91549363|NCT03858634|182980673|SUPERIORITY||LS mean difference|-18.9|STANDARD_ERROR_OF_MEAN|43.24||0.6912|TWO_SIDED|80.0|-89.75|51.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||51.89|-89.75|0.6912
91766324|NCT02981368|183421642|SUPERIORITY|||||||0.1949|||||||Fisher Exact|||Tissue Site: Bone||||0.1949
91766325|NCT02981368|183421642|SUPERIORITY|||||||0.1315|||||||Fisher Exact|||Tissue Site: Bone||||0.1315
91766326|NCT02981368|183421642|SUPERIORITY|||||||0.1977|||||||Fisher Exact|||Tissue Site: Bone||||0.1977
91766327|NCT02981368|183421642|SUPERIORITY|||||||0.2149|||||||Fisher Exact|||Tissue Site: Bone||||0.2149
91766328|NCT02981368|183421642|SUPERIORITY|||||||0.2582|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2582
91766329|NCT02981368|183421642|SUPERIORITY|||||||0.0009|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.0009
91766330|NCT02981368|183421642|SUPERIORITY|||||||0.3588|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.3588
91766331|NCT02981368|183421642|SUPERIORITY|||||||0.8791|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.8791
91766332|NCT02981368|183421642|SUPERIORITY|||||||0.9457|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.9457
91549364|NCT03858634|182980673|SUPERIORITY||LS mean difference|22.9|STANDARD_ERROR_OF_MEAN|13.07||0.0973|TWO_SIDED|80.0|5.5|40.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||40.35|5.50|0.0973
91549365|NCT03858634|182980673|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|40.33||0.289|TWO_SIDED|80.0|-133.72|18.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||18.37|-133.72|0.2890
91549366|NCT03858634|182980673|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.68||0.231|TWO_SIDED|80.0|-45.43|1.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||1.60|-45.43|0.2310
91549367|NCT03858634|182980673|SUPERIORITY||LS mean difference|-12.7|STANDARD_ERROR_OF_MEAN|45.17||0.7967|TWO_SIDED|80.0|-86.69|61.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||61.28|-86.69|0.7967
91549368|NCT03858634|182980673|SUPERIORITY||LS mean difference|16.5|STANDARD_ERROR_OF_MEAN|14.98||0.2868|TWO_SIDED|80.0|-3.5|36.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||36.44|-3.50|0.2868
91549369|NCT03858634|182980673|SUPERIORITY||LS mean difference|-64.9|STANDARD_ERROR_OF_MEAN|38.83||0.2369|TWO_SIDED|80.0|-138.08|8.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||8.37|-138.08|0.2369
91549370|NCT03858634|182980673|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.34||0.2228|TWO_SIDED|80.0|-44.97|1.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||1.17|-44.97|0.2228
91549371|NCT03858634|182980673|SUPERIORITY||LS mean difference|-14.9|STANDARD_ERROR_OF_MEAN|47.51||0.774|TWO_SIDED|80.0|-92.74|62.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||62.89|-92.74|0.7740
91549372|NCT03858634|182980673|SUPERIORITY||LS mean difference|15.1|STANDARD_ERROR_OF_MEAN|14.14||0.3|TWO_SIDED|80.0|-3.74|33.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||33.98|-3.74|0.3000
91549373|NCT03858634|182980673|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|31.37||0.1472|TWO_SIDED|80.0|-131.59|-13.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-13.30|-131.59|0.1472
91549374|NCT03858634|182980673|SUPERIORITY||LS mean difference|-12.4|STANDARD_ERROR_OF_MEAN|20.56||0.5536|TWO_SIDED|80.0|-39.77|14.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||14.94|-39.77|0.5536
91549375|NCT03858634|182980673|SUPERIORITY||LS mean difference|-17.6|STANDARD_ERROR_OF_MEAN|43.65||0.7131|TWO_SIDED|80.0|-89.13|53.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||53.84|-89.13|0.7131
91549376|NCT03858634|182980673|SUPERIORITY||LS mean difference|13.9|STANDARD_ERROR_OF_MEAN|15.27||0.3762|TWO_SIDED|80.0|-6.49|34.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||34.24|-6.49|0.3762
91549377|NCT03858634|182980673|SUPERIORITY||LS mean difference|-74.1|STANDARD_ERROR_OF_MEAN|31.37||0.1419|TWO_SIDED|80.0|-133.26|-14.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-14.97|-133.26|0.1419
91549378|NCT03858634|182980673|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|20.74||0.5817|TWO_SIDED|80.0|-39.22|15.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||15.95|-39.22|0.5817
91549379|NCT03858634|182980675|SUPERIORITY||LS mean difference|27.7|STANDARD_ERROR_OF_MEAN|55.77||0.6532|TWO_SIDED|80.0|-63.6|119.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||119.06|-63.60|0.6532
91549380|NCT03858634|182980675|SUPERIORITY||LS mean difference|23.6|STANDARD_ERROR_OF_MEAN|9.23||0.0187|TWO_SIDED|80.0|11.38|35.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||35.85|11.38|0.0187
91549381|NCT03858634|182980675|SUPERIORITY||LS mean difference|-39.3|STANDARD_ERROR_OF_MEAN|44.53||0.4707|TWO_SIDED|80.0|-123.27|44.68||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||44.68|-123.27|0.4707
91549382|NCT03858634|182980675|SUPERIORITY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.81||0.7108|TWO_SIDED|80.0|-8.22|4.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||4.59|-8.22|0.7108
91549383|NCT03858634|182980675|SUPERIORITY||LS mean difference|22.4|STANDARD_ERROR_OF_MEAN|60.36||0.7355|TWO_SIDED|80.0|-76.47|121.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||121.23|-76.47|0.7355
91549384|NCT03858634|182980675|SUPERIORITY||LS mean difference|16.9|STANDARD_ERROR_OF_MEAN|13.27||0.2167|TWO_SIDED|80.0|-0.66|34.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||34.52|-0.66|0.2167
91549385|NCT03858634|182980675|SUPERIORITY||LS mean difference|-63.5|STANDARD_ERROR_OF_MEAN|60.8||0.4058|TWO_SIDED|80.0|-178.16|51.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||51.13|-178.16|0.4058
91549386|NCT03858634|182980675|SUPERIORITY||LS mean difference|-6.4|STANDARD_ERROR_OF_MEAN|6.43||0.3323|TWO_SIDED|80.0|-14.95|2.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.15|-14.95|0.3323
91549387|NCT03858634|182980675|SUPERIORITY||LS mean difference|34.3|STANDARD_ERROR_OF_MEAN|68.11||0.6496|TWO_SIDED|80.0|-77.29|145.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||145.80|-77.29|0.6496
91549388|NCT03858634|182980675|SUPERIORITY||LS mean difference|13.8|STANDARD_ERROR_OF_MEAN|12.76||0.2925|TWO_SIDED|80.0|-3.12|30.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||30.70|-3.12|0.2925
91549389|NCT03858634|182980675|SUPERIORITY||LS mean difference|-70.7|STANDARD_ERROR_OF_MEAN|67.98||0.4074|TWO_SIDED|80.0|-198.92|57.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||57.46|-198.92|0.4074
91549390|NCT03858634|182980675|OTHER||LS mean difference|-15.5|STANDARD_ERROR_OF_MEAN|10.56||0.1584|TWO_SIDED|80.0|-29.6|-1.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.49|-29.60|0.1584
91549391|NCT03858634|182980675|SUPERIORITY||LS mean difference|-22.8|STANDARD_ERROR_OF_MEAN|54.04||0.7013|TWO_SIDED|80.0|-111.31|65.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||65.69|-111.31|0.7013
91549392|NCT03858634|182980675|SUPERIORITY||LS mean difference|13.4|STANDARD_ERROR_OF_MEAN|16.35||0.423|TWO_SIDED|80.0|-8.3|35.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||35.05|-8.30|0.4230
91549393|NCT03858634|182980675|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|57.96||0.4055|TWO_SIDED|80.0|-169.9|48.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||48.69|-169.90|0.4055
91549394|NCT03858634|182980675|SUPERIORITY||LS mean difference|-22.7|STANDARD_ERROR_OF_MEAN|11.82||0.0709|TWO_SIDED|80.0|-38.41|-6.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.96|-38.41|0.0709
91549395|NCT03858634|182980675|SUPERIORITY||LS mean difference|17.7|STANDARD_ERROR_OF_MEAN|74.17||0.8268|TWO_SIDED|80.0|-103.77|139.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||139.17|-103.77|0.8268
91549396|NCT03858634|182980675|SUPERIORITY||LS mean difference|12.4|STANDARD_ERROR_OF_MEAN|14.63||0.4082|TWO_SIDED|80.0|-7.03|31.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.75|-7.03|0.4082
91549397|NCT03858634|182980675|SUPERIORITY||LS mean difference|-50.4|STANDARD_ERROR_OF_MEAN|58.86||0.4818|TWO_SIDED|80.0|-161.43|60.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||60.56|-161.43|0.4818
91549398|NCT03858634|182980675|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|13.93||0.0673|TWO_SIDED|80.0|-45.64|-8.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.58|-45.64|0.0673
91766333|NCT02981368|183421642|SUPERIORITY|||||||0.2705|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2705
91766334|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
91549399|NCT03858634|182980675|SUPERIORITY||LS mean difference|29.6|STANDARD_ERROR_OF_MEAN|82.15||0.7429|TWO_SIDED|80.0|-105.0|164.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||164.10|-105.00|0.7429
91766335|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
91549400|NCT03858634|182980675|SUPERIORITY||LS mean difference|21.8|STANDARD_ERROR_OF_MEAN|13.55||0.1227|TWO_SIDED|80.0|3.88|39.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||39.79|3.88|0.1227
91549401|NCT03858634|182980675|SUPERIORITY||LS mean difference|-47.5|STANDARD_ERROR_OF_MEAN|58.06||0.4996|TWO_SIDED|80.0|-156.95|62.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||62.02|-156.95|0.4996
91549402|NCT03858634|182980675|SUPERIORITY||LS mean difference|-33.6|STANDARD_ERROR_OF_MEAN|13.69||0.0244|TWO_SIDED|80.0|-51.87|-15.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-15.43|-51.87|0.0244
91549403|NCT03858634|182980675|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|64.24||0.9967|TWO_SIDED|80.0|-105.5|104.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.92|-105.50|0.9967
91549404|NCT03858634|182980675|SUPERIORITY||LS mean difference|19.1|STANDARD_ERROR_OF_MEAN|13.57||0.1739|TWO_SIDED|80.0|1.15|37.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||37.12|1.15|0.1739
91549405|NCT03858634|182980675|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|51.61||0.3978|TWO_SIDED|80.0|-152.39|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||42.26|-152.39|0.3978
91549406|NCT03858634|182980675|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|14.73||0.0397|TWO_SIDED|80.0|-52.26|-13.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.07|-52.26|0.0397
91766336|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
91766337|NCT02981368|183421642|SUPERIORITY|||||||0.5933|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5933
91766338|NCT02981368|183421642|SUPERIORITY|||||||0.7094|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.7094
91766339|NCT02981368|183421642|SUPERIORITY|||||||0.5424|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5424
91766340|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: Prostate Gland||||<0.0001
91766341|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
91766342|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
91766343|NCT02981368|183421642|SUPERIORITY|||||||0.0038|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0038
91766344|NCT02981368|183421642|SUPERIORITY|||||||0.0647|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0647
91549407|NCT03858634|182980675|SUPERIORITY||LS mean difference|10.4|STANDARD_ERROR_OF_MEAN|70.66||0.8922|TWO_SIDED|80.0|-105.32|126.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||126.14|-105.32|0.8922
91549408|NCT03858634|182980675|SUPERIORITY||LS mean difference|17.3|STANDARD_ERROR_OF_MEAN|14.43||0.2439|TWO_SIDED|80.0|-1.8|36.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||36.45|-1.80|0.2439
91549409|NCT03858634|182980675|SUPERIORITY||LS mean difference|-50.3|STANDARD_ERROR_OF_MEAN|37.1||0.3076|TWO_SIDED|80.0|-120.29|19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||19.61|-120.29|0.3076
91549410|NCT03858634|182980675|SUPERIORITY||LS mean difference|-36.4|STANDARD_ERROR_OF_MEAN|15.7||0.0322|TWO_SIDED|80.0|-57.32|-15.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.55|-57.32|0.0322
91549411|NCT03858634|182980675|SUPERIORITY||LS mean difference|-94.7|STANDARD_ERROR_OF_MEAN|27.67||0.0418|TWO_SIDED|80.0|-139.98|-49.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-49.36|-139.98|0.0418
91549412|NCT03858634|182980675|SUPERIORITY||LS mean difference|24.4|STANDARD_ERROR_OF_MEAN|13.44||0.0865|TWO_SIDED|80.0|6.49|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||42.26|6.49|0.0865
91549413|NCT03858634|182980675|SUPERIORITY||LS mean difference|-48.9|STANDARD_ERROR_OF_MEAN|40.32||0.3489|TWO_SIDED|80.0|-124.96|27.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||27.11|-124.96|0.3489
91549414|NCT03858634|182980675|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|15.99||0.0286|TWO_SIDED|80.0|-59.34|-16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-16.79|-59.34|0.0286
91549415|NCT03858634|182980675|SUPERIORITY||LS mean difference|28.6|STANDARD_ERROR_OF_MEAN|72.63||0.7198|TWO_SIDED|80.0|-90.32|147.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||147.59|-90.32|0.7198
91549416|NCT03858634|182980675|SUPERIORITY||LS mean difference|39.0|STANDARD_ERROR_OF_MEAN|13.27||0.0088|TWO_SIDED|80.0|21.32|56.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||56.63|21.32|0.0088
91549417|NCT03858634|182980675|SUPERIORITY||LS mean difference|-56.5|STANDARD_ERROR_OF_MEAN|33.87||0.2371|TWO_SIDED|80.0|-120.39|7.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||7.34|-120.39|0.2371
91549418|NCT03858634|182980675|SUPERIORITY||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|16.14||0.021|TWO_SIDED|80.0|-62.3|-19.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-19.35|-62.30|0.0210
91549419|NCT03858634|182980675|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|54.07||0.7312|TWO_SIDED|80.0|-68.17|108.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||108.94|-68.17|0.7312
91549420|NCT03858634|182980675|SUPERIORITY||LS mean difference|39.4|STANDARD_ERROR_OF_MEAN|14.64||0.015|TWO_SIDED|80.0|19.88|58.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||58.83|19.88|0.0150
91549421|NCT03858634|182980675|SUPERIORITY||LS mean difference|-53.3|STANDARD_ERROR_OF_MEAN|33.87||0.2559|TWO_SIDED|80.0|-117.22|10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||10.52|-117.22|0.2559
91549422|NCT03858634|182980675|SUPERIORITY||LS mean difference|-35.0|STANDARD_ERROR_OF_MEAN|15.97||0.0419|TWO_SIDED|80.0|-56.21|-13.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-13.72|-56.21|0.0419
91549423|NCT03858634|182980675|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|60.66||0.7589|TWO_SIDED|80.0|-78.95|119.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||119.74|-78.95|0.7589
91549424|NCT03858634|182980675|SUPERIORITY||LS mean difference|39.1|STANDARD_ERROR_OF_MEAN|17.42||0.0374|TWO_SIDED|80.0|15.97|62.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||62.31|15.97|0.0374
91549425|NCT03858634|182980675|SUPERIORITY||LS mean difference|-54.9|STANDARD_ERROR_OF_MEAN|33.87||0.2463|TWO_SIDED|80.0|-118.8|8.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.93|-118.80|0.2463
91549426|NCT03858634|182980675|SUPERIORITY||LS mean difference|-33.2|STANDARD_ERROR_OF_MEAN|16.78||0.0632|TWO_SIDED|80.0|-55.56|-10.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.90|-55.56|0.0632
91549427|NCT03858634|182980675|SUPERIORITY||LS mean difference|25.7|STANDARD_ERROR_OF_MEAN|61.73||0.7053|TWO_SIDED|80.0|-75.41|126.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||126.78|-75.41|0.7053
91549428|NCT03858634|182980675|SUPERIORITY||LS mean difference|38.7|STANDARD_ERROR_OF_MEAN|16.25||0.0285|TWO_SIDED|80.0|17.09|60.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||60.34|17.09|0.0285
91766345|NCT02981368|183421642|SUPERIORITY|||||||0.0021|||||||Chi-squared|||Tissue Site: Prostate Gland||||0.0021
91766346|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
91766347|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
91766348|NCT02981368|183421642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
91766349|NCT02981368|183421642|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Tissue Site: All||||0.0815
91766350|NCT02981368|183421642|SUPERIORITY|||||||0.7507|||||||Chi-squared|||Tissue Site: All||||0.7507
91766351|NCT02981368|183421642|SUPERIORITY|||||||0.562|||||||Chi-squared|||Tissue Site: All||||0.5620
91549429|NCT03858634|182980675|SUPERIORITY||LS mean difference|-64.6|STANDARD_ERROR_OF_MEAN|37.1||0.2236|TWO_SIDED|80.0|-134.58|5.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||5.32|-134.58|0.2236
91549430|NCT03858634|182980675|OTHER||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.38||0.0558|TWO_SIDED|80.0|-58.65|-12.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-12.41|-58.65|0.0558
91549431|NCT03858634|182980675|SUPERIORITY||LS mean difference|29.9|STANDARD_ERROR_OF_MEAN|72.86||0.7089|TWO_SIDED|80.0|-89.41|149.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||149.24|-89.41|0.7089
91549432|NCT03858634|182980675|SUPERIORITY||LS mean difference|33.7|STANDARD_ERROR_OF_MEAN|14.76||0.0347|TWO_SIDED|80.0|14.08|53.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||53.35|14.08|0.0347
91549433|NCT03858634|182980675|SUPERIORITY||LS mean difference|-60.9|STANDARD_ERROR_OF_MEAN|41.94||0.2835|TWO_SIDED|80.0|-139.99|18.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||18.16|-139.99|0.2835
91549434|NCT03858634|182980675|SUPERIORITY||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.11||0.0525|TWO_SIDED|80.0|-58.31|-12.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-12.77|-58.31|0.0525
91549435|NCT03858634|182980675|SUPERIORITY||LS mean difference|24.0|STANDARD_ERROR_OF_MEAN|64.52||0.7347|TWO_SIDED|80.0|-81.68|129.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||129.66|-81.68|0.7347
91549436|NCT03858634|182980675|SUPERIORITY||LS mean difference|31.0|STANDARD_ERROR_OF_MEAN|13.94||0.039|TWO_SIDED|80.0|12.5|49.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||49.60|12.50|0.0390
91549437|NCT03858634|182980675|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|35.48||0.2299|TWO_SIDED|80.0|-127.49|6.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||6.33|-127.49|0.2299
91549438|NCT03858634|182980675|SUPERIORITY||LS mean difference|-32.6|STANDARD_ERROR_OF_MEAN|18.11||0.0884|TWO_SIDED|80.0|-56.7|-8.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-8.53|-56.70|0.0884
91549439|NCT03858634|182980675|SUPERIORITY||LS mean difference|16.3|STANDARD_ERROR_OF_MEAN|61.44||0.8085|TWO_SIDED|80.0|-84.37|116.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||116.87|-84.37|0.8085
91766352|NCT05104450|183421678|SUPERIORITY||Mean Difference (Net)|0.64||||0.001|TWO_SIDED|95.0|0.25|1.04|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||1.04|0.25|0.001
91766353|NCT05104450|183421679|SUPERIORITY||Mean Difference (Net)|-1.06||||0.037|TWO_SIDED|95.0|-2.05|-0.06|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||-0.06|-2.05|0.037
91549440|NCT03858634|182980675|SUPERIORITY||LS mean difference|19.9|STANDARD_ERROR_OF_MEAN|15.96||0.2283|TWO_SIDED|80.0|-1.33|41.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||41.14|-1.33|0.2283
91549441|NCT03858634|182980675|SUPERIORITY||LS mean difference|-69.9|STANDARD_ERROR_OF_MEAN|32.26||0.1625|TWO_SIDED|80.0|-130.76|-9.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-9.11|-130.76|0.1625
91549442|NCT03858634|182980675|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.8||0.0707|TWO_SIDED|80.0|-57.87|-10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.52|-57.87|0.0707
91549443|NCT03858634|182980675|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|50.17||0.9944|TWO_SIDED|80.0|-81.79|82.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||82.55|-81.79|0.9944
91549444|NCT03858634|182980675|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|15.16||0.1327|TWO_SIDED|80.0|3.71|44.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||44.05|3.71|0.1327
91549445|NCT03858634|182980675|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|33.87||0.1777|TWO_SIDED|80.0|-133.09|-5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-5.35|-133.09|0.1777
91549446|NCT03858634|182980675|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.4||0.2796|TWO_SIDED|80.0|-52.34|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||4.61|-52.34|0.2796
91549447|NCT03858634|182980675|SUPERIORITY||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|55.4||0.8999|TWO_SIDED|80.0|-83.15|98.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||98.30|-83.15|0.8999
91549448|NCT03858634|182980675|SUPERIORITY||LS mean difference|22.0|STANDARD_ERROR_OF_MEAN|15.99||0.1867|TWO_SIDED|80.0|0.68|43.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||43.23|0.68|0.1867
91549449|NCT03858634|182980675|SUPERIORITY||LS mean difference|-70.8|STANDARD_ERROR_OF_MEAN|33.87||0.1717|TWO_SIDED|80.0|-134.68|-6.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-6.94|-134.68|0.1717
91549450|NCT03858634|182980675|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.46||0.2792|TWO_SIDED|80.0|-52.5|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||4.61|-52.50|0.2792
91549451|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|31.41||0.2289|TWO_SIDED|80.0|-98.77|4.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.10|-98.77|0.2289
91549452|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|19.6|STANDARD_ERROR_OF_MEAN|14.08||0.1788|TWO_SIDED|80.0|0.96|38.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||38.27|0.96|0.1788
91549453|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-59.6|STANDARD_ERROR_OF_MEAN|114.35||0.6544|TWO_SIDED|80.0|-275.19|156.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||156.06|-275.19|0.6544
91549454|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-72.2|STANDARD_ERROR_OF_MEAN|20.4||0.0023|TWO_SIDED|80.0|-99.39|-45.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-45.09|-99.39|0.0023
91549455|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-14.47|-89.68|0.1081
91549456|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|21.37||0.4926|TWO_SIDED|80.0|-13.39|43.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||43.26|-13.39|0.4926
91549457|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||467.98|-361.63|0.8315
91549458|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-69.9|STANDARD_ERROR_OF_MEAN|18.56||0.0014|TWO_SIDED|80.0|-94.61|-45.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-45.22|-94.61|0.0014
91549459|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-14.47|-89.68|0.1081
91549460|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|21.97||0.7339|TWO_SIDED|80.0|-21.65|36.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||36.82|-21.65|0.7339
91549461|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||467.98|-361.63|0.8315
91549462|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-67.6|STANDARD_ERROR_OF_MEAN|21.26||0.0055|TWO_SIDED|80.0|-95.92|-39.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-39.22|-95.92|0.0055
91549463|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|26.73||0.1188|TWO_SIDED|80.0|-101.7|-14.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-14.15|-101.70|0.1188
91549464|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|18.27||0.8697|TWO_SIDED|80.0|-21.26|27.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||27.35|-21.26|0.8697
91549465|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|78.64||0.7368|TWO_SIDED|80.0|-178.62|117.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||117.94|-178.62|0.7368
91549466|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|15.02||0.5571|TWO_SIDED|80.0|-29.03|11.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||11.03|-29.03|0.5571
91549467|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|32.21||0.2251|TWO_SIDED|80.0|-101.8|3.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||3.69|-101.80|0.2251
91549468|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|18.93||0.3733|TWO_SIDED|80.0|-7.9|42.48||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||42.48|-7.90|0.3733
91549469|NCT03858634|182980677|SUPERIORITY||LS Mean Difference|-22.6|STANDARD_ERROR_OF_MEAN|66.57||0.7662|TWO_SIDED|80.0|-148.16|102.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||102.89|-148.16|0.7662
91549470|NCT03858634|182980677|OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|16.87||0.7241|TWO_SIDED|80.0|-28.54|16.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.44|-28.54|0.7241
91549471|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|29.04||0.5195|TWO_SIDED|80.0|-68.69|26.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||26.43|-68.69|0.5195
91549472|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|11.3|STANDARD_ERROR_OF_MEAN|8.27||0.1869|TWO_SIDED|80.0|0.34|22.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.26|0.34|0.1869
91549473|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-87.5|STANDARD_ERROR_OF_MEAN|55.3||0.2545|TWO_SIDED|80.0|-191.75|16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||16.79|-191.75|0.2545
91549474|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|10.26||0.0643|TWO_SIDED|80.0|-33.88|-6.57||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.57|-33.88|0.0643
91549475|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|20.11||0.2503|TWO_SIDED|80.0|-61.52|4.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||4.35|-61.52|0.2503
91549476|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|11.58||0.8468|TWO_SIDED|80.0|-13.08|17.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||17.62|-13.08|0.8468
91549477|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-83.6|STANDARD_ERROR_OF_MEAN|73.93||0.3755|TWO_SIDED|80.0|-222.98|55.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||55.18|-222.98|0.3755
91549478|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-20.9|STANDARD_ERROR_OF_MEAN|11.06||0.0755|TWO_SIDED|80.0|-35.58|-6.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-6.15|-35.58|0.0755
91549479|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|25.77||0.3486|TWO_SIDED|80.0|-70.76|13.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||13.65|-70.76|0.3486
91549480|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.69||0.6559|TWO_SIDED|80.0|-17.28|8.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.50|-17.28|0.6559
91549481|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-70.2|STANDARD_ERROR_OF_MEAN|50.46||0.2987|TWO_SIDED|80.0|-165.35|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||24.94|-165.35|0.2987
91549482|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|12.43||0.1966|TWO_SIDED|80.0|-33.29|-0.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-0.13|-33.29|0.1966
91549483|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-41.5|STANDARD_ERROR_OF_MEAN|25.7||0.2051|TWO_SIDED|80.0|-83.56|0.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||0.62|-83.56|0.2051
91549484|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|10.16||0.7511|TWO_SIDED|80.0|-16.79|10.25||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||10.25|-16.79|0.7511
91549485|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-79.6|STANDARD_DEVIATION|39.27||0.1797|TWO_SIDED|80.0|-153.68|-5.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-5.59|-153.68|0.1797
91549486|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|11.45||0.1715|TWO_SIDED|80.0|-31.61|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-1.08|-31.61|0.1715
91549487|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-36.5|STANDARD_ERROR_OF_MEAN|21.32||0.185|TWO_SIDED|80.0|-71.47|-1.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-1.63|-71.47|0.1850
91549488|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|12.19||0.6907|TWO_SIDED|80.0|-21.15|11.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||11.29|-21.15|0.6907
91549489|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-74.0|STANDARD_ERROR_OF_MEAN|23.85||0.0901|TWO_SIDED|80.0|-118.97|-29.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-29.02|-118.97|0.0901
91549490|NCT03858634|182980679|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|13.34||0.564|TWO_SIDED|80.0|-25.64|9.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.94|-25.64|0.5640
91549491|NCT03858634|182980680|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||31.76|-95.11|0.4734
91549492|NCT03858634|182980680|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||16.18|-23.33|0.8130
91549493|NCT03858634|182980680|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-33.32|-150.60|0.0979
91549494|NCT03858634|182980680|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-19.61|-55.48|0.0122
91549495|NCT05457647|182980728|OTHER|The accuracy and precision of the theranostic imaging biomarkers, including both the riboflavin score and theranostic score, to predict CXL treatment outcome were determined by calculating the proportion of correctly classified eyes and the positive predictive value respectively.|Proportion|91.0|||||TWO_SIDED|95.0|||||||The study set a minimum threshold of 85 for the the combined use of the theranostic imaging biomarkers' accuracy and precision in predicting the propensity of CXL to halt disease progression at 1 year in the study population.|Accuracy and precision of the combined use of theranostic imaging biomarkers generated by the UV-A device to predict the propensity of CXL in flattening the Kmax value at 12-months.||||
91549496|NCT05457647|182980729|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of Kmax value at 12-months follow-up visit.||||<0.05
91549497|NCT05457647|182980730|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of ECD value at 12-months follow-up visit.||||<0.05
91549498|NCT05457647|182980731|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of MSER value at 12-months follow-up visit.||||<0.05
91549499|NCT05457647|182980732|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CDVA value at 12-months follow-up visit.||||<0.05
91549500|NCT05457647|182980733|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of UDVA value at 12-months follow-up visit.||||<0.05
91549501|NCT05457647|182980734|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CCT value at 12-months follow-up visit.||||<0.05
91549502|NCT05457647|182980735|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively. Bonferroni correction was applied to analysis of exploratory outcome measures of stratification groups.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91549503|NCT03115476|182980738|OTHER||Hazard Ratio (HR)|1.43||||0.43|TWO_SIDED|95.0|0.61|3.9|||likelihood ratio test|||Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio||3.9|0.61|0.43
91549504|NCT03115476|182980739|OTHER||Hazard Ratio (HR)|1.99|||<|0.01|TWO_SIDED|95.0|1.17|3.62|||likelihood ratio test|||relative difference between treatment groups (ingenol disoxate gel vs vehicle) expressed as hazard ratio||3.62|1.17|<0.01
91549505|NCT04204265|182980746|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91549506|NCT04204265|182980747|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91549507|NCT04204265|182980748|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91549508|NCT02465268|182980751|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.196|TWO_SIDED|95.0|0.77|2.16|||Log Rank|||||2.16|0.77|0.196
91549509|NCT02465268|182980751|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.196|TWO_SIDED|95.0|0.99|2.7|||Log Rank|||||2.70|0.99|0.196
91549510|NCT02465268|182980752|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.354|TWO_SIDED|95.0|0.6|1.61|||Log Rank|||||1.61|0.60|0.354
91549511|NCT02465268|182980752|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.354|TWO_SIDED|95.0|0.87|2.33|||Log Rank|||||2.33|0.87|0.354
91549512|NCT02465268|182980753|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
91549513|NCT02465268|182980753|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
91549514|NCT02465268|182980753|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
91549515|NCT02465268|182980755|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
91549516|NCT02465268|182980755|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
91549517|NCT02465268|182980755|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
91549518|NCT02465268|182980756|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
91549519|NCT02465268|182980756|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
91549520|NCT02465268|182980756|OTHER|||||||0.6|||||||Kruskal-Wallis|||||||0.6
91549521|NCT02465268|182980758|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
91549522|NCT02465268|182980758|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
91549523|NCT02465268|182980758|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
91549524|NCT02876588|182980759|SUPERIORITY||Odds Ratio (OR)|1.03||||0.6|TWO_SIDED|95.0|0.9|1.2||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, and the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.20|.90|.60
91549525|NCT02876588|182980760|SUPERIORITY||Odds Ratio (OR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.19||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.19|.89|.68
91549526|NCT02876588|182980761|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91549527|NCT02547363|182980762|SUPERIORITY||||||<|0.001|||||||Fisher exact test|||||||<0.001
91549528|NCT02547363|182980763|SUPERIORITY||Ratio of clearance rates|62.59|||<|0.001|TWO_SIDED|95.0|8.68|451.08|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||451.08|8.68|<0.001
91766354|NCT05104450|183421680|SUPERIORITY||Mean Difference (Net)|0.37||||0.135|TWO_SIDED|95.0|-0.12|0.86|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.86|-0.12|0.135
91766355|NCT05104450|183421681|SUPERIORITY||Mean Difference (Net)|-0.97||||0.068|TWO_SIDED|95.0|-2.01|0.07|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.07|-2.01|0.068
91549529|NCT02547363|182980764|SUPERIORITY||Ratio of clearance rates|59.21|||<|0.001|TWO_SIDED|95.0|8.44|415.35|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||415.35|8.44|<0.001
91766356|NCT05104450|183421682|SUPERIORITY||Mean Difference (Net)|-2.71|||<|0.001|TWO_SIDED|95.0|-3.83|-1.6|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||-1.60|-3.83|<0.001
91766357|NCT05104450|183421683|SUPERIORITY||Mean Difference (Net)|0.87||||0.401|TWO_SIDED|95.0|-1.16|2.89|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, Charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||2.89|-1.16|0.401
91549530|NCT02547363|182980765|SUPERIORITY||Week 8 AK count ratio|0.27|||<|0.001|TWO_SIDED|95.0|0.23|0.32|||Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.23|<0.001
91549531|NCT05228457|182980785|SUPERIORITY|13 participants were randomized to receive active TMS, and 13 were randomized to receive sham TMS. 1 participant from each group withdrew, resulting in their exclusion from the analysis. Therefore, 24 participants were randomized to active (n = 12) or sham (n = 12) aiTBS groups. The analysis examined MADRS scores measured at baseline and post-treatment. A priori hypotheses were that active aiTBS would demonstrate measurable differences in MADRS scores compared to the sham group.|Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-19.94|-9.56|||t-test, 2 sided||The primary outcome was the between-group (Active vs Sham) difference in MADRS scores at the end of the treatment period. Results, including mean scores, standard deviations, confidence intervals, and p-value for the between-group comparisons.|||-9.56|-19.94|<0.001
91549532|NCT05228457|182980786|SUPERIORITY||Z-transformed Pearson's r values|-0.014||||0.04|TWO_SIDED||||||t-test, 2 sided|||Z-transformed Pearson's r values of average voxel-wise connectivity within the DMN||||0.04
91766358|NCT05104450|183421684|SUPERIORITY||Mean Difference (Net)|-0.51||||0.034|TWO_SIDED|95.0|-0.98|-0.04|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||-0.04|-0.98|0.034
91549533|NCT04382664|182980787|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.845|TWO_SIDED|80.0|0.694|1.309|||Regression, Cox|||||1.309|0.694|0.845
91549534|NCT03161028|182980806|SUPERIORITY|||||||0.51||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||For the model evaluating the primary outcome (change in T25FW), T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). Any participants who were unable to complete the T25FW at any timepoint after baseline were assigned a value of 199 seconds, a statistical technique known as Winsorizing.||||0.51
91549535|NCT03161028|182980807|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
91549536|NCT03161028|182980808|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
91549537|NCT03161028|182980809|SUPERIORITY|||||||0.084|||||||Mixed Models Analysis|||||||0.084
91549538|NCT03161028|182980810|SUPERIORITY|||||||0.134|||||||Chi-squared|||||||0.134
91766359|NCT05104450|183421685|SUPERIORITY||Mean Difference (Final Values)|-3.11||||0.061|TWO_SIDED|95.0|-6.37|0.15|||Mixed Models Analysis|one-time measures: Beta Estimates|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).||0.15|-6.37|0.061
91766360|NCT05104450|183421686|SUPERIORITY||Mean Difference (Net)|-0.46||||0.469|TWO_SIDED|95.0|-1.69|0.78|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.78|-1.69|0.469
91766361|NCT05104450|183421687|SUPERIORITY||Mean Difference (Net)|0.78|||<|0.001|TWO_SIDED|95.0|0.42|1.13|||Mixed Models Analysis|treatment-by-time interaction||Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|1.13|0.42|<0.001
91549539|NCT01799265|182980817|NON_INFERIORITY|The 95% upper limit of the prediction interval was calculated using the formula (μ ) ̂+t\_(k-2)\^α √((τ\^2 ) ̂+〖(SE) ̂(μ ̂ )〗\^2 ),where (μ ) ̂is the estimate average AHI across all studies, (τ\^2 ) ̂ is the between-study variation, t\_(k-2)\^α is the critical value for a t-distribution, k is the number of studies in the meta-analysis, and k-2 are the degrees of freedom for the t distribution. Meta-analyzed statistics to compute the prediction interval were (μ ) ̂=5.0, SE(μ ̂ )=0.9, and (τ\^2 ) ̂=8.0||||||0.05|||||||t-test, 1 sided|A p-value of .05 was used.||"Hypothesis testing for the primary endpoint was conducted using a one-sided test of non-inferiority with the following null and alternative hypotheses at the 0.05 significance level using the MIXED procedure in SAS, version 9.3:~H\_0:(ϕ\_m ) ̂≥6.9 H\_A:(ϕ\_m ) ̂\<6.9 where (ϕ\_m ) ̂ is the estimated AHI difference between Transcend Auto and REMstar Auto from the model described in 3.5.1."||||.05
91549540|NCT03084536|182980836|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
91549541|NCT03084536|182980837|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
91549542|NCT03084536|182980838|SUPERIORITY|||||||0.53|||||||Kruskal-Wallis|||||||0.53
91549543|NCT03084536|182980839|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
91549544|NCT03084536|182980840|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
91549545|NCT04285515|182980862|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-7.6|-3.84|||Mixed Effects Model for Repeated Measure|||||-3.84|-7.60|<0.0001
91549546|NCT04285515|182980863|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.29|-3.05|||Mixed Effects Model for Repeated Measure|||||-3.05|-8.29|<0.0001
91549547|NCT04285515|182980864|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-8.61|-3.29|||Mixed Effects Model for Repeated Measure|||||-3.29|-8.61|<0.0001
91549548|NCT04285515|182980865|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-7.25|-3.88|||Mixed Effects Model for Repeated Measure|||||-3.88|-7.25|<0.0001
91549549|NCT04285515|182980866|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39|||Mixed Effects Model of Repeated Measure|||||-0.39|-0.81|<0.0001
91549550|NCT04285515|182980867|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.91|-0.31|||Mixed Effects Model for Repeated Measure|||||-0.31|-0.91|<0.0001
91549551|NCT04285515|182980868|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.89|-0.27|||Mixed Effects Model for Repeated Measure|||||-0.27|-0.89|0.0003
91549552|NCT04285515|182980869|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.44|||Mixed Effects Model for Repeated Measure|||||-0.44|-0.82|<0.0001
91549553|NCT04986501|182980871|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
91549554|NCT04986501|182980873|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
91549555|NCT01084876|182980902|EQUIVALENCE|The therapeutic equivalence between CT-P6 and Herceptin is concluded if the 95% confidence interval (CI) for the risk difference (CT-P6 - Herceptin) estimate in ORR ITRC review during the Main Study Treatment Period is entirely within the predefined equivalence margin of -0.15 to 0.15.|Risk Difference (RD)|-0.0535|||||TWO_SIDED|95.0|-0.143|0.036||||||||0.036|-0.143|
91549556|NCT04342494|182980937|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PHQ-9 score via analysis of covariance.||||||0.31|||||||ANCOVA|||||||0.31
91549557|NCT04342494|182980938|EQUIVALENCE|Average mood score obtained from daily measurements analyzed via analysis of variance||||||0.0073|||||||ANOVA|||||||0.0073
91549558|NCT04342494|182980939|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-PI score via analysis of covariance||||||0.03|||||||ANCOVA|||||||0.03
91549559|NCT04342494|182980940|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-NSI score via analysis of covariance||||||0.71|||||||ANCOVA|||||||0.71
91549560|NCT04342494|182980941|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline GAD-7 score via analysis of covariance||||||0.31|||||||ANCOVA|||||||0.31
91549561|NCT03736720|182980943|OTHER|No statistical test.|Proportion|0.091|||||TWO_SIDED|80.0|0.033|0.301|||||Estimated using Jeffrey's prior method.|||0.301|0.033|
91766362|NCT05104450|183421688|SUPERIORITY||Mean Difference (Net)|0.47||||0.031|TWO_SIDED|95.0|0.04|0.89|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.89|0.04|0.031
91766363|NCT05104450|183421689|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.118|TWO_SIDED|95.0|-0.21|0.02|||Mixed Models Analysis|one-time measures: Beta Estimates|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).||0.02|-0.21|0.118
91766364|NCT05104450|183421690|SUPERIORITY||Mean Difference (Net)|3.93||||0.011|TWO_SIDED|95.0|0.91|6.95|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||6.95|0.91|0.011
91766365|NCT05104450|183421691|SUPERIORITY||Mean Difference (Net)|0.44||||0.074|TWO_SIDED|95.0|-0.04|0.93|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.93|-0.04|0.074
91549562|NCT03736720|182980949|SUPERIORITY|||||||0.289|||||||Sign test|two-sided test.||Comparing the pre-treatment and end of treatment QoL scores.||||0.289
91549563|NCT05119023|182980954|OTHER|||||||0.39||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language Severity and Characterization of learning: SRT Observational Learning Scores||||0.39
91549564|NCT05119023|182980954|OTHER||||||<|0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Observational Learning Scores||||<0.01
91549565|NCT05119023|182980954|OTHER|||||||0.95||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Rule-based Learning Scores||||0.95
91549566|NCT05119023|182980955|OTHER|Sample underpowered for regression so correlation examined||||||0.36||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: SRT Observational Learning Scores||||0.36
91549567|NCT05119023|182980955|OTHER|||||||0.09|||||||Pearson's correlation|The threshold for statistical significance was p = 0.05||Examination of Attention and Characterization of learning: AGL Observational Learning Scores||||0.09
91549568|NCT05119023|182980955|OTHER|||||||0.32||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: AGL Rule Based Learning||||0.32
91549569|NCT05119023|182980956|OTHER|Sample underpowered for regression so correlation examined||||||0.64||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: SRT Observational Learning Scores||||0.64
91549570|NCT05119023|182980956|OTHER|||||||0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Observational Learning Scores||||0.01
91549571|NCT05119023|182980956|OTHER|||||||0.79|||||||Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Rule-based Learning Scores||||0.79
91549572|NCT05119023|182980957|OTHER|Sample underpowered for regression so correlation examined||||||0.9||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: SRT Observational Learning Scores||||0.90
91549573|NCT05119023|182980957|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Observational Learning Scores||||0.09
91766366|NCT05104450|183421692|SUPERIORITY||Mean Difference (Net)|-1.71||||0.003|TWO_SIDED|95.0|-2.82|-0.59|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||-0.59|-2.82|0.003
91766367|NCT05104450|183421693|SUPERIORITY||Mean Difference (Net)|-0.7||||0.229|TWO_SIDED|95.0|-1.84|0.44|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.44|-1.84|0.229
91766368|NCT05104450|183421694|SUPERIORITY||Mean Difference (Net)|-2.51|||<|0.001|TWO_SIDED|95.0|-3.72|-1.29|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||-1.29|-3.72|<0.001
91766369|NCT05104450|183421695|SUPERIORITY||Mean Difference (Net)|-1.02||||0.116|TWO_SIDED|95.0|-2.3|0.25|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.25|-2.30|0.116
91766370|NCT05104450|183421696|SUPERIORITY||Mean Difference (Net)|0.05||||0.968|TWO_SIDED|95.0|-2.35|2.45|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||2.45|-2.35|0.968
91549574|NCT05119023|182980957|OTHER|||||||0.24|||||||Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Rule-based Learning Scores||||0.24
91549575|NCT03194217|182980959|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.68|1.08|||ANCOVA|||||1.08|-1.68|0.668
91549576|NCT03194217|182980959|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.7||0.213|TWO_SIDED|95.0|-0.5|2.26|||ANCOVA|||||2.26|-0.50|0.213
91549577|NCT03194217|182980959|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.7||0.575|TWO_SIDED|95.0|-1.76|0.98|||ANCOVA|||||0.98|-1.76|0.575
91549578|NCT02962895|182980960|SUPERIORITY||Least Squares Mean Difference|0.75||||0.5161|TWO_SIDED|95.0|-1.52|3.02|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.02|-1.52|0.5161
91549579|NCT02962895|182980960|SUPERIORITY||Least Squares Mean Difference|-0.55||||0.6332|TWO_SIDED|95.0|-2.8|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.71|-2.80|0.6332
91549580|NCT02962895|182980960|SUPERIORITY||Least Squares Mean Difference|-1.92||||0.0921|TWO_SIDED|95.0|-4.15|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.32|-4.15|0.0921
91549581|NCT02962895|182980962|SUPERIORITY||Least Squares Mean Difference|0.32||||0.4457|TWO_SIDED|95.0|-0.5|1.13|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||1.13|-0.50|0.4457
91549582|NCT02962895|182980962|SUPERIORITY||Least Square Mean Difference|0.01||||0.301|TWO_SIDED|95.0|-0.79|0.82|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||0.82|-0.79|0.301
91549583|NCT02962895|182980962|SUPERIORITY||Least Square Mean Difference|-0.06||||0.8858|TWO_SIDED|95.0|-0.86|0.74|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.74|-0.86|0.8858
91549584|NCT02962895|182980964|SUPERIORITY||Least Squares Mean Difference|-1.93||||0.3424|TWO_SIDED|95.0|-5.93|2.07|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||2.07|-5.93|0.3424
91549585|NCT02962895|182980964|SUPERIORITY||Least Squares Mean Difference|-2.56||||0.2092|TWO_SIDED|95.0|-6.58|1.45|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.45|-6.58|0.2092
91549586|NCT02962895|182980964|SUPERIORITY||Least Squares Mean Difference|0.31||||0.874|TWO_SIDED|95.0|-3.58|4.2|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.20|-3.58|0.8740
91549587|NCT02962895|182980966|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.5768|TWO_SIDED|95.0|-4.61|2.57|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Mental Component Score||2.57|-4.61|0.5768
91549588|NCT02962895|182980966|SUPERIORITY||Least Squares Mean Difference|0.68||||0.7113|TWO_SIDED|95.0|-2.93|4.28|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Mental Component Score||4.28|-2.93|0.7113
91549589|NCT02962895|182980966|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5722|TWO_SIDED|95.0|-2.49|4.48|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Mental Component Score||4.48|-2.49|0.5722
91549590|NCT02962895|182980966|SUPERIORITY||Least Squares Mean Difference|1.84||||0.4138|TWO_SIDED|95.0|-1.59|3.83|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Physical Component Score||3.83|-1.59|0.4138
91549591|NCT02962895|182980966|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.4663|TWO_SIDED|95.0|-3.72|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Physical Component Score||1.71|-3.72|0.4663
91549592|NCT02962895|182980966|SUPERIORITY||Least Squares Mean Difference|1.84||||0.1694|TWO_SIDED|95.0|-0.79|4.47|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Physical Component Score||4.47|-0.79|0.1694
91549593|NCT02962895|182980968|SUPERIORITY||Least Squares Mean Difference|-4.17||||0.2671|TWO_SIDED|95.0|-11.56|3.22|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.22|-11.56|0.2671
91549594|NCT02962895|182980968|SUPERIORITY||Least Squares Mean Difference|-4.49||||0.2248|TWO_SIDED|95.0|-11.78|2.79|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||2.79|-11.78|0.2248
91766371|NCT05104450|183421697|SUPERIORITY||Mean Difference (Net)|0.84||||0.218|TWO_SIDED|95.0|-0.49|2.17|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||2.17|-0.49|0.218
91549595|NCT02962895|182980968|SUPERIORITY||Least Squares Mean Difference|-8.36||||0.0224|TWO_SIDED|95.0|-15.51|-1.2|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||-1.20|-15.51|0.0224
91549596|NCT02962895|182980970|SUPERIORITY||Least Squares Mean Difference|2.27||||0.6457|TWO_SIDED|95.0|-7.46|12.0|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||12.00|-7.46|0.6457
91549597|NCT02962895|182980970|SUPERIORITY||Least Squares Mean Difference|3.26||||0.5132|TWO_SIDED|95.0|-6.55|13.06|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||13.06|-6.55|0.5132
91549598|NCT02962895|182980970|SUPERIORITY||Least Squares Mean Difference|-4.77||||95|TWO_SIDED|95.0|-14.21|4.68|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.68|-14.21|95
91549599|NCT02962895|182980971|SUPERIORITY||Least Squares Mean Difference|0.11||||0.271|TWO_SIDED|95.0|-0.08|0.3|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Stimulated salivary flow rate)||0.30|-0.08|0.2710
91549600|NCT02962895|182980971|SUPERIORITY||Least Squares Mean Difference|0.13||||0.1618|TWO_SIDED|95.0|-0.05|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Stimulated salivary flow rate)||0.32|-0.05|0.1618
91549601|NCT02962895|182980971|SUPERIORITY||Least Squares Mean Difference|0.2||||0.0374|TWO_SIDED|95.0|0.01|0.38|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Stimulated salivary flow rate)||0.38|0.01|0.0374
91549602|NCT02962895|182980971|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9559|TWO_SIDED|95.0|-0.09|0.09|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Unstimulated salivary flow rate)||0.09|-0.09|0.9559
91549603|NCT02962895|182980971|SUPERIORITY||Least Squares Mean Difference|0.0||||0.929|TWO_SIDED|95.0|-0.09|0.08|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Unstimulated salivary flow rate)||0.08|-0.09|0.9290
91549604|NCT02962895|182980971|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.7276|TWO_SIDED|95.0|-0.1|0.07|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Unstimulated salivary flow rate)||0.07|-0.10|0.7276
91549605|NCT04509674|182980977|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2061|TWO_SIDED|95.0|0.76|1.06||"Null hypothesis: there is no difference regarding the risk of the endpoint in question between empagliflozin and placebo.~p\<=0.05 required for testing of subsequent key secondary endpoint hypotheses"|Regression, Cox||Empagliflozin vs. Placebo|The primary endpoint was analysed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.||1.06|0.76|0.2061
91549606|NCT04509674|182980978|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.2423|TWO_SIDED|95.0|0.68|1.1|||Negative binomial regression||Empagliflozin vs. Placebo|||1.10|0.68|0.2423
91549607|NCT04509674|182980979|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.92||||0.2867|TWO_SIDED|95.0|0.78|1.07|||Negative binomial regression||Empagliflozin vs. Placebo|||1.07|0.78|0.2867
91549608|NCT04509674|182980980|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.0463|TWO_SIDED|95.0|0.7654|0.9978|||Negative binomial regression||Empagliflozin vs. Placebo|||0.9978|0.7654|0.0463
91549609|NCT04509674|182980981|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|1.06||||0.6311|TWO_SIDED|95.0|0.83|1.35|||Negative binomial regression||Empagliflozin vs. Placebo|||1.35|0.83|0.6311
91549610|NCT04509674|182980982|OTHER|The statistical analysis was performed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.|Hazard Ratio (HR)|1.03||||0.8124||95.0|0.81|1.31|||Regression, Cox||Empagliflozin vs. Placebo|||1.31|0.81|0.8124
91766372|NCT05104450|183421698|SUPERIORITY||Mean Difference (Net)|1.02||||0.212|TWO_SIDED|95.0|-0.58|2.62|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||2.62|-0.58|0.212
91766373|NCT05104450|183421699|SUPERIORITY||Mean Difference (Net)|0.06||||0.8|TWO_SIDED|95.0|-0.44|0.57|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.57|-0.44|0.800
91766374|NCT05104450|183421700|SUPERIORITY||Mean Difference (Net)|0.27||||0.317|TWO_SIDED|95.0|-0.26|0.79|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||0.79|-0.26|0.317
91766375|NCT05104450|183421701|SUPERIORITY||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.44|-0.17|||Mixed Models Analysis|one-time measures: Beta Estimates|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).||-0.17|-0.44|<0.001
91766376|NCT05104450|183421702|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.107|TWO_SIDED|95.0|-0.27|0.03|||Mixed Models Analysis|one-time measures: Beta Estimates|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).||0.03|-0.27|0.107
91549611|NCT03896789|182981081|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.95|TWO_SIDED|95.0|-3.3|3.5||The primary outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||"Null hypothesis: Assuming no difference between usual care (control) and PEGASUS (intervention).~We used 2011-2012 results from prior pilot work in Argentina (58.6% TBI guideline adherence) to determine a sample size of 432 eligible patients (216 per arm) for the planned parallel cluster RCT, which would have 80% power to detect a 18.7% higher ICU TBI guideline adherence rate with programme implementation, with a two-sided alpha of 5%, and an intraclass coefficient of 0.05."||3.5|-3.3|.95
91549612|NCT03896789|182981087|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.01|TWO_SIDED|95.0|1.9|13.8||The outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||||13.8|1.9|.01
91549613|NCT05851573|182981088|OTHER||||||<|0.05|||||||t-test, 2 sided|df = 9||||||< .05
91549614|NCT05851573|182981089|OTHER||||||=|0.775|||||||t-test, 2 sided|df = 9||||||= .775
91549615|NCT05851573|182981090|OTHER||||||=|0.444|||||||t-test, 2 sided|df = 10||||||= .444
91549616|NCT05851573|182981091|OTHER|||||||0.959|||||||t-test, 2 sided|df = 9||||||.959
91549617|NCT05851573|182981092|OTHER|||||||0.068|||||||t-test, 2 sided|df = 9||||||.068
91549618|NCT05851573|182981093|OTHER||||||=|0.119|||||||t-test, 2 sided|df = 10||||||= .119
91766377|NCT05104450|183421703|SUPERIORITY||Mean Difference (Net)|4.07||||0.013|TWO_SIDED|95.0|0.86|7.27|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||7.27|0.86|0.013
91549619|NCT05851573|182981094|OTHER||||||=|0.258|||||||t-test, 2 sided|df = 10||||||= .258
91549620|NCT05851573|182981095|OTHER||||||=|0.593|||||||t-test, 2 sided|df = 10||||||= .593
91766378|NCT05104450|183421704|SUPERIORITY||Mean Difference (Net)|3.11||||0.065|TWO_SIDED|95.0|-0.2|6.42|||Mixed Models Analysis|treatment-by-time interaction|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including baseline and follow up outcome measures, time, treatment by time interaction, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60). The parameter of interest is treatment by time interaction coefficient, measuring the between group difference for change in outcome.||6.42|-0.20|0.065
91549621|NCT04473222|182981123|SUPERIORITY||Odds Ratio, log|-0.15||||0.026|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||.026
91549622|NCT04473222|182981124|SUPERIORITY||Odds Ratio, log|-0.2||||0.032|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||0.032
91549623|NCT04473222|182981125|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.01|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||.010
91549624|NCT04473222|182981126|SUPERIORITY||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.009||0.161|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.161
91549625|NCT04473222|182981127|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.01||0.006|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.006
91549626|NCT04473222|182981128|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.045|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.045
91549627|NCT04473222|182981129|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.685|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.685
91549628|NCT04473222|182981130|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|1.22||0.734|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.734
91549629|NCT04473222|182981131|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.019
91549630|NCT04473222|182981132|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.776|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.776
91549631|NCT01098812|182981137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|75.0|<|0.0001|ONE_SIDED|90.0|25.0|||Primary study endpoint; therefore, no adjustment for multiple comparisons. The planned alpha level for testing was 0.025.|t-test, 1 sided|||Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is \<= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is \> the control. There is 80% power to detect \>=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.|||25|<0.0001
91549632|NCT01098812|182981138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.15||0.0009|ONE_SIDED|90.0||-0.03||P-value compared to alpha level adjusted for multiplicity of 0.0125.|t-test, 1 sided|||Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect \>=0.06 LogMAR difference in mean UCDVA between IOL groups.||-0.03||0.0009
91549633|NCT02319759|182981139|SUPERIORITY||Percent difference|39.7|||<|0.001|TWO_SIDED|95.0|25.3|54.1|||Cochran-Mantel-Haenszel|||||54.1|25.3|<0.001
91549634|NCT02319759|182981140|SUPERIORITY||Percentage (%) Difference|66.1|||<|0.001|TWO_SIDED|95.0|53.8|78.4|||Cochran-Mantel-Haenszel|||||78.4|53.8|<0.001
91549635|NCT02319759|182981141|SUPERIORITY||Least Square Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.471|-0.148|||MMRM|MMRM stands for Mixed-effects Model Repeated Measures||||-0.148|-0.471|<0.001
91549636|NCT01389856|182981183|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
91549637|NCT01389856|182981184|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3407|TWO_SIDED||||||Log Rank|||||||0.3407
91549638|NCT01389856|182981185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2399|TWO_SIDED||||||Log Rank|||||||0.2399
91549639|NCT01389856|182981187|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
91549640|NCT01389856|182981188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2235|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2235
91549641|NCT01389856|182981189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1468|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1468
91766379|NCT05104450|183421705|SUPERIORITY||Mean Difference (Final Values)|-3.63||||0.041|TWO_SIDED|95.0|-7.11|-0.14|||Mixed Models Analysis|one-time measures: Beta Estimates|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed effects model including each participant's outcome measure, baseline covariates: age, gender, race, charlson comorbidity index, rurality, and randomization stratification variables: BMI (30-34.9 vs. 35-44.9kg/m2), OSA severity (mild vs. moderate to severe), and sleep related impairment T-score (\<60 vs. ≥ 60).||-0.14|-7.11|0.041
91549642|NCT01389856|182981190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0789|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0789
91549643|NCT01389856|182981191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3723
91549644|NCT01389856|182981192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0569|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0569
91549645|NCT01389856|182981193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1015
91549646|NCT01389856|182981194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0824
91549647|NCT01389856|182981195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3863|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3863
91549648|NCT01389856|182981196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3936
91549649|NCT01389856|182981197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2436|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2436
91549650|NCT01389856|182981198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1756|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1756
91549651|NCT01389856|182981199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1155|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1155
91549652|NCT01389856|182981200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1400
91549653|NCT03959696|182981216|SUPERIORITY||Mean Difference (Net)|0.36||||0.011|TWO_SIDED|95.0|0.08|0.64||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure|Mean difference is the Training + Notification arm minus the Notification only arm|The null hypothesis SDMP is equal in the two arms||.64|.08|.011
91549654|NCT03959696|182981217|SUPERIORITY||Mean Difference (Net)|1.77||||0.36|TWO_SIDED|95.0|-2.01|5.55||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure||The null hypothesis is that the two arms have the same knowledge score||5.55|-2.01|0.36
91549655|NCT03959696|182981218|SUPERIORITY|We will have 81% power to detect a difference of 14% in rates (e.g. decrease from 61% to 47%).||||||0.47|||||||Regression, Logistic|||We will compare the percentages of patients who received their preferred screening in the 12 months after the visit across the two groups using logistic regression model with the GEE approach to adjust for clustering of patients within clinicians.||||0.47
91549656|NCT03959696|182981219|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
91549657|NCT03959696|182981220|SUPERIORITY||Risk Difference (RD)|9.4||||0.032|TWO_SIDED|95.0|0.9|18.0|||Chi-squared|||Null hypothesis was equal screening rate in both arms||18.0|0.9|0.032
91549658|NCT03959696|182981221|SUPERIORITY||Risk Difference (RD)|1.5||||0.64|TWO_SIDED||||||Chi-squared|||||||0.64
91549659|NCT05604508|182981254|OTHER||Odds Ratio (OR)|0.735|||||TWO_SIDED|95.0|0.347|1.553|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions|||1.553|0.347|
91549660|NCT05604508|182981254|OTHER||Odds Ratio (OR)|0.471|||||TWO_SIDED|95.0|0.234|0.947|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions.|||0.947|0.234|
91549661|NCT05604508|182981255|OTHER||Odds Ratio (OR)|1.503|||||TWO_SIDED|95.0|0.727|3.107|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||3.107|0.727|
91549662|NCT05604508|182981255|OTHER||Odds Ratio (OR)|0.878|||||TWO_SIDED|95.0|0.398|1.938|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||1.938|0.398|
91549663|NCT05604508|182981256|OTHER||Odds Ratio (OR)|0.619|||||TWO_SIDED|95.0|0.295|1.301|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline smokeless use intentions|||1.301|0.295|
91549664|NCT05604508|182981256|OTHER||Odds Ratio (OR)|0.489|||||TWO_SIDED|95.0|0.237|1.006|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco, baseline smokeless use intentions|||1.006|0.237|
91549665|NCT05604508|182981257|OTHER||Odds Ratio (OR)|1.428|||||TWO_SIDED|95.0|0.72|2.832|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.832|0.720|
91549666|NCT05604508|182981257|OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.681|2.96|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.960|0.681|
91549667|NCT03097549|182981322|SUPERIORITY||Estimated difference|-3.1||||0.001|TWO_SIDED|95.0|-4.8|-1.3|||Mixed Models Analysis|||Comparison of mean scores using a linear mixed model, incorporating baseline data and accounting for all available data. Sample size calculation: We anticipated ICIQ-UI SF improvements of 2.5 points in the treatment group and 0.9 points in the information group. Detecting this difference with 80% power, a two-sided test, and a significance level of P\<.05 would require a sample size of 49 in each group. With an expected drop-out rate of 20%, we needed approximately 60 participants in each group.||-1.3|-4.8|0.001
91549668|NCT03097549|182981323|SUPERIORITY||Estimated difference|-6.3||||0.004|TWO_SIDED|95.0|-10.5|-2.1|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-2.1|-10.5|0.004
91549669|NCT03097549|182981324|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: There is no difference in the number of urinary leakage episodes between the treatment app users and the information app users at follow-up.~ITT analysis. Missing data: 5 participants in the treatment group and 2 participants in the information group had a missing value at follow-up, and for those, the difference was set to 0 (ie, no change)."||||<0.001
91549670|NCT03097549|182981325|SUPERIORITY||Estimated difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.9|-2.8|<0.001
91766380|NCT01584232|183421706|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to insulin glargine.|LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).|Mixed Models Analysis|||Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.||-0.41|-0.67|<0.001
91766381|NCT01584232|183421707|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<=6.5%.|Regression, Logistic|||||||<0.001
91766382|NCT01584232|183421707|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<7%.|Regression, Logistic|||||||<0.001
91766383|NCT01584232|183421708|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.183|TWO_SIDED|95.0|-1.7|8.7|||Mixed Models Analysis|||||8.7|-1.7|0.183
91766384|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16||||0.022|TWO_SIDED|95.0|0.76|9.56||Treatment comparison for pre-morning meal.|ANCOVA|||||9.56|0.76|0.022
91766385|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.4||||0.003|TWO_SIDED|95.0|-22.28|-4.52||Treatment comparison for 2 hours post-morning meal.|ANCOVA|||||-4.52|-22.28|0.003
91766386|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.22||||0.025|TWO_SIDED|95.0|-15.37|-1.06||Treatment comparison for pre-midday meal.|ANCOVA|||||-1.06|-15.37|0.025
91766387|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.22|||<|0.001|TWO_SIDED|95.0|-31.92|-14.51||Treatment comparison for 2 hours post-midday meal.|ANCOVA|||||-14.51|-31.92|<0.001
91766388|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|||<|0.001|TWO_SIDED|95.0|-21.03|-6.24||Treatment comparison for pre-evening meal.|ANCOVA|||||-6.24|-21.03|<0.001
91766389|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.13|||<|0.001|TWO_SIDED|95.0|-39.26|-23.0||Treatment comparison for 2 hours post-evening meal.|ANCOVA|||||-23.00|-39.26|<0.001
91766390|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.73|||<|0.001|TWO_SIDED|95.0|-31.68|-15.79||Treatment comparison for bedtime.|ANCOVA|||||-15.79|-31.68|<0.001
91766391|NCT01584232|183421709|SUPERIORITY_OR_OTHER||LS Mean Difference|6.21||||0.005|TWO_SIDED|95.0|1.92|10.5||Treatment comparison for second pre-morning meal.|ANCOVA|||||10.50|1.92|0.005
91766392|NCT01584232|183421710|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.89|-0.94|||Mixed Models Analysis|||||-0.94|-1.89|<0.001
91766393|NCT01584232|183421711|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91766394|NCT01307319|183421712|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.63|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.3|-1.0|<0.001
91766395|NCT01307319|183421712|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
91766396|NCT01307319|183421713|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||The power calculation assumed the standard deviation (SD) for the change from baseline over two weeks in the average of AM and PM reflective TNSS is assumed to be 2.0. Using this standard deviation, 235 subjects per arm provides 90% power to detect a difference of 0.60 in TNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.3|-1.1|<0.001
91549671|NCT03097549|182981326|SUPERIORITY||Estimated difference|-1.6||||0.016|TWO_SIDED|95.0|-2.8|-0.3|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.3|-2.8|0.016
91549672|NCT03097549|182981327|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in usage between treatment group and information group at follow-up.||||0.01
91549673|NCT03097549|182981328|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in improvement between the treatment group and the information group att follow-up.||||<0.001
91549674|NCT05415722|182981352|SUPERIORITY||Mean Difference (Final Values)|-11.39|STANDARD_ERROR_OF_MEAN|7.48||0.1303|TWO_SIDED|95.0|-26.178|3.406|||ANCOVA|||Arm 1 compared to Placebo||3.406|-26.178|0.1303
91549675|NCT05415722|182981352|SUPERIORITY||Mean Difference (Final Values)|-23.47|STANDARD_ERROR_OF_MEAN|7.924||0.0036|TWO_SIDED|95.0|-39.14|-7.799|||ANCOVA|||Arm 2 compared to Placebo||-7.799|-39.140|0.0036
91549676|NCT05415722|182981352|SUPERIORITY||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|7.96|<|0.0001|TWO_SIDED|95.0|-56.545|-25.064|||ANCOVA|||Arm 3 compared to Placebo||-25.064|-56.545|<0.0001
91549677|NCT05415722|182981353|SUPERIORITY||Mean Difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|20.87||0.1289|TWO_SIDED|95.0|-73.17|9.39|||ANCOVA|||Arm 1 compared to Placebo||9.39|-73.17|0.1289
91549678|NCT05415722|182981353|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|21.65||0.179|TWO_SIDED|95.0|-72.08|13.58|||ANCOVA|||Arm 2 compared to Placebo||13.58|-72.08|0.1790
91549679|NCT05415722|182981353|SUPERIORITY||Mean Difference (Final Values)|-75.7|STANDARD_ERROR_OF_MEAN|21.96||0.0008|TWO_SIDED|95.0|-119.08|-32.23|||ANCOVA|||Arm 3 compared to Placebo||-32.23|-119.08|0.0008
91549680|NCT05415722|182981354|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.895||0.0358|TWO_SIDED|95.0|-32.352|-1.128|||ANCOVA|||Arm 4 compared to Placebo||-1.128|-32.352|0.0358
91549681|NCT05415722|182981354|SUPERIORITY||Mean Difference (Final Values)|-43.73|STANDARD_ERROR_OF_MEAN|7.647|<|0.0001|TWO_SIDED|95.0|-58.858|-28.612|||ANCOVA|||Arm 5 compared to Placebo||-28.612|-58.858|<0.0001
91549682|NCT05415722|182981355|SUPERIORITY||Mean Difference (Final Values)|-62.6|STANDARD_ERROR_OF_MEAN|22.09||0.0053|TWO_SIDED|95.0|-106.33|-18.96|||ANCOVA|||Arm 4 compared to Placebo||-18.96|-106.33|0.0053
91549683|NCT05415722|182981355|SUPERIORITY||Mean Difference (Final Values)|-69.2|STANDARD_ERROR_OF_MEAN|21.13||0.0014|TWO_SIDED|95.0|-110.97|-27.39|||ANCOVA|||Arm 5 compared to Placebo||-27.39|-110.97|0.0014
91549684|NCT03524612|182981359|OTHER||||||<|0.0001|||||||Clopper Pearson test|||||||<0.0001
91766397|NCT01307319|183421713|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
91766398|NCT02152631|183421732|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.771|TWO_SIDED|95.0|0.768|1.219|||Stratified Log-Rank||Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.|The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS \[G12C\] vs. all others)||1.219|0.768|0.771
91549685|NCT03848065|182981477|OTHER||Difference in Percentages|17.8||||0.004|TWO_SIDED|95.0|9.0|31.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Erythema (Redness)||31.4|9.0|0.004
91549686|NCT03848065|182981477|OTHER||Difference in Percentages|4.7||||0.15|TWO_SIDED|95.0|-3.7|15.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Erythema (Redness)||15.5|-3.7|0.150
91549687|NCT03848065|182981477|OTHER||Difference in Percentages|-13.1||||0.054|TWO_SIDED|95.0|-27.6|0.2|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Erythema (Redness)||0.2|-27.6|0.054
91549688|NCT03848065|182981477|OTHER||Difference in Percentages|13.1||||0.091|TWO_SIDED|95.0|-2.3|28.8|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Induration (Hard Lump)||28.8|-2.3|0.091
91549689|NCT03848065|182981477|OTHER||Difference in Percentages|-9.1||||0.044|TWO_SIDED|95.0|-21.2|-0.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Induration (Hard Lump)||-0.4|-21.2|0.044
91549690|NCT03848065|182981477|OTHER||Difference in Percentages|-22.2||||0.001|TWO_SIDED|95.0|-36.4|-12.5|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Induration (Hard Lump)||-12.5|-36.4|0.001
91549691|NCT03848065|182981477|OTHER||Difference in Percentages|9.7||||0.333|TWO_SIDED|95.0|-10.0|28.9|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Pain||28.9|-10.0|0.333
91549692|NCT03848065|182981477|OTHER||Difference in Percentages|-3.2||||0.76|TWO_SIDED|95.0|-23.4|17.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Pain||17.2|-23.4|0.760
91549693|NCT03848065|182981477|OTHER||Difference in Percentages|-13.0||||0.205|TWO_SIDED|95.0|-32.2|7.1|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Pain||7.1|-32.2|0.205
91549694|NCT03848065|182981477|OTHER||Difference in Percentages|13.0||||0.128|TWO_SIDED|95.0|-3.9|29.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Swelling||29.7|-3.9|0.128
91549695|NCT03848065|182981477|OTHER||Difference in Percentages|-2.0||||0.779|TWO_SIDED|95.0|-17.0|13.0|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Swelling||13.0|-17.0|0.779
91549696|NCT03848065|182981477|OTHER||Difference in Parentages|-15.0||||0.076|TWO_SIDED|95.0|-31.5|1.7|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Swelling||1.7|-31.5|0.076
91549697|NCT03848065|182981478|OTHER||Difference in Percentages|-10.6||||0.282|TWO_SIDED|95.0|-29.1|8.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Decreased Appetite (Appetite Loss)||8.7|-29.1|0.282
91549698|NCT03848065|182981478|OTHER||Difference in Percentages|-9.9||||0.317|TWO_SIDED|95.0|-28.7|9.5|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Decreased Appetite (Appetite Loss)||9.5|-28.7|0.317
91549699|NCT03848065|182981478|OTHER||Difference in Percentages|0.7||||0.948|TWO_SIDED|95.0|-19.2|20.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Decreased Appetite (Appetite Loss)||20.4|-19.2|0.948
91549700|NCT03848065|182981478|OTHER||Difference in Percentages|10.5||||0.303|TWO_SIDED|95.0|-9.4|29.6|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Somnolence (Drowsiness)||29.6|-9.4|0.303
91549701|NCT03848065|182981478|OTHER||Difference in Percentages|-4.0||||0.681|TWO_SIDED|95.0|-22.6|15.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Somnolence (Drowsiness)||15.0|-22.6|0.681
91549702|NCT03848065|182981478|OTHER||Difference in Percentages|-14.4||||0.153|TWO_SIDED|95.0|-33.2|5.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Somnolence (Drowsiness)||5.4|-33.2|0.153
91549703|NCT03848065|182981478|OTHER||Difference in Percentages|10.7||||0.237|TWO_SIDED|95.0|-7.2|28.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Irritability||28.2|-7.2|0.237
91549704|NCT03848065|182981478|OTHER||Difference in Percentages|7.4||||0.406|TWO_SIDED|95.0|-10.3|25.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Irritability||25.0|-10.3|0.406
91549705|NCT03848065|182981478|OTHER||Difference in Percentages|-3.3||||0.729|TWO_SIDED|95.0|-21.8|15.5|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Irritability||15.5|-21.8|0.729
91549706|NCT03848065|182981478|OTHER||Difference in Percentages|4.6||||0.385|TWO_SIDED|95.0|-7.1|17.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Urticaria (Hives/Welts)||17.5|-7.1|0.385
91549707|NCT03848065|182981478|OTHER||Difference in Percentages|2.1||||0.719|TWO_SIDED|95.0|-11.0|15.4|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Urticaria (Hives/Welts)||15.4|-11.0|0.719
91549708|NCT03848065|182981478|OTHER||Difference in Percentages|-2.5||||0.61|TWO_SIDED|95.0|-14.9|8.9|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Urticaria (Hives/Welts)||8.9|-14.9|0.610
91549709|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-8.1|
91549710|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-7.9|
91549711|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||7.9|-8.1|
91549712|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114- SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||8.5|-8.1|
91549713|NCT03848065|182981480|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||6.3|-11.7|
91766399|NCT02152631|183421733|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS \[G12C\] vs. all others)||||0.010
91766400|NCT02152631|183421734|SUPERIORITY||Hazard Ratio (HR)|0.583|||<|1e-06|TWO_SIDED|95.0|0.47|0.723|||Stratified Log-Rank|||||0.723|0.470|<0.000001
91549714|NCT03848065|182981480|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||11.6|-6.0|
91549715|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-8.1|
91549716|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-7.9|
91549717|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||7.9|-8.1|
91549718|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-8.1|
91549719|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-7.9|
91549720|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||7.9|-8.1|
91549721|NCT03848065|182981480|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||6.3|-11.9|
91549722|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||8.5|-7.9|
91549723|NCT03848065|182981480|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||5.8|-11.9|
91549724|NCT03848065|182981480|OTHER||Difference in Percentages|-9.1|||||TWO_SIDED|95.0|-21.2|-0.2|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||-0.2|-21.2|
91549725|NCT03848065|182981480|OTHER||Difference in Percentages|-6.7|||||TWO_SIDED|95.0|-17.9|2.1|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||2.1|-17.9|
91549726|NCT03848065|182981480|OTHER||Difference in Percentages|-2.4|||||TWO_SIDED|95.0|-15.6|10.2|||||Difference=% V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||10.2|-15.6|
91549727|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||8.5|-8.1|
91549728|NCT03848065|182981480|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||6.3|-11.7|
91549729|NCT03848065|182981480|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||11.6|-6.0|
91549730|NCT03848065|182981480|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-8.1|
91549731|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-7.9|
91549732|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||7.9|-8.1|
91549733|NCT03848065|182981480|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||6.3|-11.9|
91549734|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||8.5|-7.9|
91549735|NCT03848065|182981480|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||5.8|-11.9|
91549736|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-8.1|
91549737|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-7.9|
91549738|NCT03848065|182981480|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||7.9|-8.1|
91549739|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-8.1|
91549740|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-7.9|
91549741|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||7.9|-8.1|
91549742|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-8.1|
91549743|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-7.9|
91766401|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.698|TWO_SIDED|95.0|-0.44|0.29|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Headache||0.29|-0.44|0.698
91766402|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|0.59|STANDARD_ERROR_OF_MEAN|0.28||0.038|TWO_SIDED|95.0|0.03|1.15|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Diarrhea||1.15|0.03|0.038
91549744|NCT03848065|182981480|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||7.9|-8.1|
91549745|NCT03848065|182981480|OTHER||Difference in Percentages|0.1|||||TWO_SIDED|95.0|-9.8|10.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||10.4|-9.8|
91549746|NCT03848065|182981480|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||12.4|-5.7|
91766403|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.94|-1.86|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Rash||-1.86|-2.94|<.001
91549747|NCT03848065|182981480|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||5.8|-11.9|
91549748|NCT03848065|182981480|OTHER||Difference in Percentages|90.7|||||TWO_SIDED|95.0|77.2|96.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||96.4|77.2|
91549749|NCT03848065|182981480|OTHER||Difference in Percentages|95.2|||||TWO_SIDED|95.0|84.1|98.7|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||98.7|84.1|
91549750|NCT03848065|182981480|OTHER||Difference in Percentages|-4.5|||||TWO_SIDED|95.0|-15.2|3.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||3.6|-15.2|
91549751|NCT03848065|182981480|OTHER||Difference in Percentages|81.8|||||TWO_SIDED|95.0|67.9|90.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||90.5|67.9|
91549752|NCT03848065|182981480|OTHER||Difference in Percentages|88.9|||||TWO_SIDED|95.0|76.4|95.2|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||95.2|76.4|
91549753|NCT03848065|182981480|OTHER||Difference in Percentages|-7.1|||||TWO_SIDED|95.0|-22.7|8.2|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||8.2|-22.7|
91549754|NCT03848065|182981481|OTHER||Geometric Mean Concentration (GMC) Ratio|0.76|||||TWO_SIDED|95.0|0.58|1.0|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an analysis of variance (ANOVA) model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 1||1.00|0.58|
91549755|NCT03848065|182981481|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.13|0.65|
91549756|NCT03848065|182981481|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.68|1.16|||||GMC Ratio=GMC V114-SC/GMC V114-IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.16|0.68|
91549757|NCT03848065|182981481|OTHER||GMC Ratio|1.3|||||TWO_SIDED|95.0|0.96|1.76|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.76|0.96|
91549758|NCT03848065|182981481|OTHER||GMC Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.01|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||2.01|1.10|
91549759|NCT03848065|182981481|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.65|1.18|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.18|0.65|
91549760|NCT03848065|182981481|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||0.90|0.58|
91549761|NCT03848065|182981481|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.0|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.00|0.65|
91549762|NCT03848065|182981481|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.11|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.11|0.72|
91549763|NCT03848065|182981481|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.16|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.16|0.60|
91549764|NCT03848065|182981481|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.69|1.31|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.31|0.69|
91549765|NCT03848065|182981481|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.21|0.64|
91549766|NCT03848065|182981481|OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.84|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.84|0.47|
91549767|NCT03848065|182981481|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.52|0.93|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.93|0.52|
91549768|NCT03848065|182981481|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||1.21|0.68|
91549769|NCT03848065|182981481|OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.79|0.36|
91549770|NCT03848065|182981481|OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.90|0.41|
91549771|NCT03848065|182981481|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||1.30|0.59|
91766404|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.142|TWO_SIDED|95.0|-0.56|0.08|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Symptom Severity||0.08|-0.56|0.142
91549772|NCT03848065|182981481|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.81|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.81|0.46|
91549773|NCT03848065|182981481|OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.90|0.52|
91549774|NCT03848065|182981481|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.67|1.17|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||1.17|0.67|
91549775|NCT03848065|182981481|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||0.99|0.57|
91549776|NCT03848065|182981481|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.13|0.65|
91766405|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.514|TWO_SIDED|95.0|-0.59|0.3|||Mixed Models Analysis|Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Interference||0.30|-0.59|0.514
91549777|NCT03848065|182981481|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.67|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.15|0.67|
91549778|NCT03848065|182981481|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.19|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.19|0.60|
91549779|NCT03848065|182981481|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.72|1.43|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.43|0.72|
91549780|NCT03848065|182981481|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.59|1.16|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.16|0.59|
91549781|NCT03848065|182981481|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.53|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.90|0.53|
91766406|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Lung Cancer||0.23|-0.37|0.646
91549782|NCT03848065|182981481|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.92|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.92|0.54|
91549783|NCT03848065|182981481|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.76|1.27|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||1.27|0.76|
91549784|NCT03848065|182981481|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.15|0.66|
91549785|NCT03848065|182981481|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.55|0.96|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||0.96|0.55|
91549786|NCT03848065|182981481|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|0.9|1.57|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.57|0.90|
91549787|NCT03848065|182981481|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.57|0.89|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.89|0.57|
91549788|NCT03848065|182981481|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.95|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.95|0.62|
91766407|NCT02152631|183421735|SUPERIORITY||LS Mean Change Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.188|TWO_SIDED|95.0|-0.51|0.1|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Plus Lung Cancer||0.10|-0.51|0.188
91549789|NCT03848065|182981481|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||1.15|0.75|
91549790|NCT03848065|182981481|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.57|1.09|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.57|
91549791|NCT03848065|182981481|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.58|
91549792|NCT03848065|182981481|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.73|1.36|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.36|0.73|
91549793|NCT03848065|182981481|OTHER||GMC Ratio|134.88|||||TWO_SIDED|95.0|88.91|204.62|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||204.62|88.91|
91549794|NCT03848065|182981481|OTHER||GMC Ratio|204.6|||||TWO_SIDED|95.0|135.18|309.69|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||309.69|135.18|
91549795|NCT03848065|182981481|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.44|0.99|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||0.99|0.44|
91549796|NCT03848065|182981481|OTHER||GMC Ratio|25.11|||||TWO_SIDED|95.0|15.34|41.13|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||41.13|15.34|
91549797|NCT03848065|182981481|OTHER||GMC Ratio|34.18|||||TWO_SIDED|95.0|20.93|55.83|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||55.83|20.93|
91549798|NCT03848065|182981481|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.45|1.19|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||1.19|0.45|
91549799|NCT03848065|182981482|OTHER||Difference in Percentages|2.5|||||TWO_SIDED|95.0|-7.7|13.9|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.9|-7.7|
91549800|NCT03848065|182981482|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-10.8|12.0|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||12.0|-10.8|
91549801|NCT03848065|182981482|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-8.0|13.0|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.0|-8.0|
91549802|NCT03848065|182981482|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.8|12.4|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.8|
91549803|NCT03848065|182981482|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.7|
91549804|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||7.9|-8.1|
91549805|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-8.1|
91549806|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-7.9|
91549807|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||7.9|-8.1|
91549808|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-8.1|
91549809|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-7.9|
91549810|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||7.9|-8.1|
91549811|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-8.1|
91549812|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-7.9|
91549813|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||7.9|-8.1|
91549814|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-8.1|
91549815|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-7.9|
91549816|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||7.9|-8.1|
91549817|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||8.5|-8.1|
91766408|NCT02152631|183421737|SUPERIORITY||LS Mean Change Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.951|TWO_SIDED|95.0|-0.05|0.05|||Mixed Models Analysis|Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment\*Visit + Baseline.||||0.05|-0.05|0.951
91766409|NCT03776747|183421742|OTHER|Analysis of variance between lung inflation levels|||||<|0.001|||||||ANOVA|||We hypothesized that the anisotropic deformation index (ADC) is dependent upon lung inflation level. (Thus, it is important to standardize lung inflation when using this method)||||<0.001
91766410|NCT00527735|183421746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806||||0.1302|TWO_SIDED|95.0|0.553|1.174|||1-sided log rank|||||1.174|0.553|0.1302
91549818|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||"Difference = % V114-IM minus % PCV13~-SC. The 95% CI is based on the Miettinen and Nurminen method."|Poliovirus Type 3||8.5|-7.9|
91766411|NCT00527735|183421746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.0473|TWO_SIDED|95.0|0.495|1.059|||1-sided log rank|||||1.059|0.495|0.0473
91549819|NCT03848065|182981482|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||7.9|-8.1|
91549820|NCT00764751|182981507|SUPERIORITY||Mean Difference (Final Values)|15.4|||=|0.003|TWO_SIDED|95.0|5.6|25.0|||Paired t-test|||||25|5.6|=0.003
91549821|NCT00764751|182981507|SUPERIORITY||Mean Difference (Final Values)|-17.1||||0.07|TWO_SIDED|95.0|-36.0|1.9|||Paired t-test|||||1.9|-36.0|0.07
91549822|NCT05270408|182981536|SUPERIORITY||Cohen's d|0.93||||0.25|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.25
91549823|NCT05270408|182981536|SUPERIORITY||Cohen's d|0.69||||0.18|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.18
91549824|NCT05270408|182981536|SUPERIORITY||Cohen's d|0.74||||0.48|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.48
91549825|NCT05270408|182981536|SUPERIORITY||Cohen's d|0.19||||0.64|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.64
91549826|NCT05270408|182981537|SUPERIORITY||Cohen's d|0.03||||0.98|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.98
91766412|NCT00527735|183421747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.2502|TWO_SIDED|95.0|0.612|1.271|||One-sided log rank|||||1.271|0.612|0.2502
91766413|NCT00527735|183421747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.024|TWO_SIDED|95.0|0.478|0.999|||One-sided log rank|||||0.999|0.478|0.0240
91549827|NCT05270408|182981537|SUPERIORITY||Cohen's d|0.86||||0.22|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.22
91549828|NCT05270408|182981537|SUPERIORITY||Cohen's d|0.04||||0.97|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.97
91549829|NCT05270408|182981537|SUPERIORITY||Cohen's d|0.69||||0.23|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.23
91549830|NCT05270408|182981538|SUPERIORITY||Cohen's d|0.04||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
91549831|NCT05270408|182981538|SUPERIORITY||Cohen's d|0.42||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
91549832|NCT05270408|182981539|SUPERIORITY||Cohen's d|1.49||||0.06|TWO_SIDED||||||ANCOVA|||||||0.06
91549833|NCT05270408|182981539|SUPERIORITY||Cohen's d|1.08||||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
91549834|NCT05270408|182981540|SUPERIORITY||Cohen's d|0.19||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
91549835|NCT05270408|182981540|SUPERIORITY||Cohen's d|0.68||||0.38|TWO_SIDED||||||ANCOVA|||||||0.38
91549836|NCT05270408|182981542|SUPERIORITY||Cohen's d|0.96||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
91549837|NCT05270408|182981542|SUPERIORITY|||||||0.68|||||||ANCOVA||||Eta2 effect sizes produced from the pairwise comparisons were transformed to Cohen's d for examination of effect sizes. A small/weak effect size was demonstrated (Cohen's d = 0.10), when adjusting for baseline performance.|||0.68
91549838|NCT05717907|182981689|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
91549839|NCT05546749|182981694|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.93||0.17|TWO_SIDED|95.0|-3.1|0.54|||Mixed Models Analysis|||A mixed effects model was performed to predict pain intensity by arm at weeks 3 and 6, controlling for baseline pain intensity score.||0.54|-3.1|0.17
91549840|NCT05546749|182981695|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|13.6||0.32|TWO_SIDED|95.0|-40.3|13.1|||Mixed Models Analysis|||A mixed effects model was used to predict opioid craving score by arm at weeks 3 and 6, controlling for baseline opioid craving score.||13.1|-40.3|0.32
91549841|NCT05546749|182981704|SUPERIORITY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|6.1||0.137|TWO_SIDED|95.0|-23.1|3.6|||Regression, Linear||RelieVRx was associated with lower stress score.|We performed a mixed effects model to predict stress score at week 6 by arm, controlling for baseline stress score.||3.6|-23.1|0.137
91766414|NCT00527735|183421748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.4759|TWO_SIDED|95.0|0.669|1.46|||1-sided log rank|||||1.460|0.669|0.4759
91766415|NCT00527735|183421748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.234|TWO_SIDED|95.0|0.587|1.278|||1-sided log rank|||||1.278|0.587|0.2340
91766416|NCT00527735|183421755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.1098|TWO_SIDED|95.0|0.475|1.188|||1-sided log rank|||||1.188|0.475|0.1098
91766417|NCT00527735|183421755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0282|TWO_SIDED|95.0|0.403|1.1016|||1-sided log rank|||||1.1016|0.403|0.0282
91766418|NCT00527735|183421764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.3846|TWO_SIDED|95.0|0.588|1.481|||1-sided Log Rank|||||1.481|0.588|0.3846
91766419|NCT00527735|183421764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.37|TWO_SIDED|95.0|0.591|1.453|||1-sided Log Rank|||||1.453|0.591|0.3700
91549842|NCT02561247|182981726|OTHER|||||||0.0008||||||P Value is from a one sample t-test compared against the null hypothesis value|t-test, 1 sided|Null Hypothesis Value = -38; Degrees of Freedom=16; t-value=-4.13||P Value is from a one sample t-test compared against the null hypothesis value. No adjustments were made for multiple comparisons/multiplicity in this study, since there was only one primary endpoint, one arm, and one pre-specified primary null hypothesis.||||0.0008
91549843|NCT04908722|182981731|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.15|||||TWO_SIDED|97.5|0.926|1.44||||||Group 1 (1 dose) vs Group 3 (1 dose)||1.440|0.926|
91549844|NCT04908722|182981731|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.8||||||97.5|0.641|1.0||||||Group 5 (1 dose) vs Group 3 (1 dose)||1.00|0.641|
91549845|NCT04908722|182981731|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.07|||||TWO_SIDED|97.5|0.844|1.356||||||Group 2 (1 dose) vs Group 3 (1 dose)||1.356|0.844|
91549846|NCT04908722|182981731|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.742|1.193||||||Group 4 (1 dose) vs Group 3 (1 dose)||1.193|0.742|
91549847|NCT04908722|182981731|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.81|||||TWO_SIDED|97.5|0.648|1.007||||||Group 6 (1 dose) vs Group 3 (1 dose)||1.007|0.648|
91549848|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.53|||||TWO_SIDED|97.5|1.992|3.207||||||Group 1 (2 doses) vs Group 3 (1 dose)||3.207|1.992|
91549849|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.41|||||TWO_SIDED|97.5|1.088|1.815||||||Group 1 (2 doses) vs Group 3 (2 doses)||1.815|1.088|
91549850|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.79|||||TWO_SIDED|97.5|1.408|2.265||||||Group 5 (2 doses) vs Group 3 (1 dose)||2.265|1.408|
91549851|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.769|1.282||||||Group 5 (2 doses) vs Group 3 (2 doses)||1.282|0.769|
91549852|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.37|||||TWO_SIDED|97.5|1.829|3.007||||||Group 2 (2 doses) vs Group 3 (1 dose)||3.007|1.829|
91549853|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.32|||||TWO_SIDED|97.5|1.0|1.739||||||Group 2 (2 doses) vs Group 3 (2 doses)||1.739|1.000|
91549854|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.2|||||TWO_SIDED|97.5|1.697|2.841||||||Group 4 (2 doses) vs Group 3 (1 dose)||2.841|1.697|
91549855|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.22|||||TWO_SIDED|97.5|0.928|1.606||||||Group 4 (2 doses) vs Group 3 (2 doses)||1.606|0.928|
91549856|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.7|||||TWO_SIDED|97.5|1.348|2.148||||||Group 6 (2 doses) vs Group 3 (1 dose)||2.148|1.348|
91549857|NCT04908722|182981732|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.95|||||TWO_SIDED|97.5|0.736|1.217||||||Group 6 (2 doses) vs Group 3 (2 doses)||1.217|0.736|
91549858|NCT06321809|182981742|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses.||total scale score comparison||||0.24
91549859|NCT06321809|182981742|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.001
91549860|NCT06321809|182981742|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.03
91549861|NCT06321809|182981742|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.003
91549862|NCT06321809|182981743|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Weight comparison||||0.08
91549863|NCT06321809|182981744|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||BMI Comparison||||0.13
91549864|NCT06321809|182981745|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Waist Circumference Comparison||||0.63
91549865|NCT06321809|182981746|SUPERIORITY|||||||0.89|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||LDL Cholesterol Comparison||||0.89
91549866|NCT03131154|182981747|OTHER||Hazard Ratio (HR)|1.129|||||TWO_SIDED|95.0|0.643|1.982|||||Cox proportional hazards model|||1.982|0.643|
91549867|NCT03131154|182981748|OTHER||Hazard Ratio (HR)|2.619|||||TWO_SIDED|95.0|0.989|6.939|||||Cox proportional hazards model|||6.939|0.989|
91549868|NCT06424236|182981749|SUPERIORITY||Least square (LS) mean|-0.1166|STANDARD_DEVIATION|0.29505||0.0117|TWO_SIDED|95.0|-0.206|-0.0272|||Mixed Model for Repeated Measures (MMRM)|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.0272|-0.2060|0.0117
91766420|NCT00527735|183421767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.4132|TWO_SIDED|95.0|0.585|1.536|||1-sided Log Rank|||||1.536|0.585|0.4132
91766421|NCT00527735|183421767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.753||||0.1287|TWO_SIDED|95.0|0.461|1.232|||1-sided Log Rank|||||1.232|0.461|0.1287
91766422|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.052||||||6 hour pain at rest|t-test, 2 sided|||||||0.052
91549869|NCT06424236|182981749|OTHER||LS mean|-0.4648|STANDARD_DEVIATION|0.46591|<|0.0001|TWO_SIDED|95.0|-0.5971|-0.3326|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.3326|-0.5971|<0.0001
91549870|NCT06424236|182981749|OTHER||LS mean|-0.7062|STANDARD_DEVIATION|0.43787|<|0.0001|TWO_SIDED|95.0|-0.8821|-0.5303|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.5303|-0.8821|<0.0001
91766423|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.064||||||6 hour pain with movement|t-test, 2 sided|||||||0.064
91766424|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.139|||||||t-test, 2 sided|12 hour pain at rest||||||0.139
91766425|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.35||||||12 hour pain at rest|t-test, 2 sided|||||||0.350
91766426|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.021||||||18 hour pain at rest|t-test, 2 sided|||||||0.021
91549871|NCT06424236|182981750|SUPERIORITY|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.32||||0.4535|TWO_SIDED|95.0|0.64|2.7|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Asymptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||2.70|0.64|0.4535
91766427|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.198||||||18 hour pain with movement|t-test, 2 sided|||||||0.198
91766428|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.806|||||||t-test, 2 sided|24 hour pain at rest||||||0.806
91766429|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.228||||||24 hour pain with movement|t-test, 2 sided|||||||0.228
91766430|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.457||||||36 hour pain at rest|t-test, 2 sided|||||||0.457
91766431|NCT02271698|183421804|SUPERIORITY_OR_OTHER|||||||0.394||||||36 hour pain with movement|t-test, 2 sided|||||||0.394
91766432|NCT02271698|183421805|SUPERIORITY_OR_OTHER|||||||0.181||||||6 hours|t-test, 2 sided|||||||0.181
91766433|NCT02271698|183421805|SUPERIORITY_OR_OTHER|||||||0.364||||||12 hours|t-test, 2 sided|||||||0.364
91766434|NCT02271698|183421805|SUPERIORITY_OR_OTHER|||||||0.605|||||||t-test, 2 sided|18 hours||||||0.605
91766435|NCT02271698|183421805|SUPERIORITY_OR_OTHER|||||||0.733|||||||t-test, 2 sided|24 hours||||||0.733
91766436|NCT02271698|183421805|SUPERIORITY_OR_OTHER|||||||0.6||||||36 hours|t-test, 2 sided|||||||0.600
91766437|NCT01507688|183421841|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|||||P-value was not adjusted for multiple comparisons. Models adjusted for: VA vs Non Va, admission diagnosis (transient ischemic attack vs stroke), sex (male vs female), white vs nonwhite, and baseline total Stroke Specific Quality of life score.|Mixed Models Analysis|Repeated measurements of change GEE analyses of Total Stroke Specific Quality of Life score change at 6 months from baseline.|The adjusted positive mean (standard error) change at 6 months from baseline was higher in the intervention arm compared to in the control arm. Intervention group had 0.14 (SE 0.17) higher improvement compared to the control group.|"All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis."||||0.0500
91766438|NCT01507688|183421841|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|||||Adjusted least square means (standard errors) adjusted for treatment (Intervention vs control), time of outcome from baseline (3, 6, 12 months), baseline SSQoL, Site (VA vs NonVA), Stroke/TIA diagnosis, sex (m vs f) and race (white vs nonwhite).|Mixed Models Analysis||Adjusted intervention arm's positive change (regression coefficient with standard error) in Total Stroke Specific Quality of Life was not significantly different at 12 months compared to the control group.|"We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis."||||0.26
91766439|NCT02107703|183421842|OTHER||Hazard Ratio (HR)|0.553|||<|1e-07|TWO_SIDED|95.0|0.449|0.681||This is two sided P value and it is statistically significant.|Log Rank|Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).||The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.||0.681|0.449|<0.0000001
91766440|NCT00964496|183421863|SUPERIORITY_OR_OTHER||Differences in proportions|0.677||||1.3e-07|TWO_SIDED|95.0|0.547|0.807||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.807|0.547|0.00000013
91549872|NCT06424236|182981750|OTHER|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.18||||0.4848|TWO_SIDED|95.0|0.74|1.86|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Symptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||1.86|0.74|0.4848
91549873|NCT06424236|182981751|OTHER||Hazard Ratio (HR)|0.93||||0.8855|TWO_SIDED|95.0|0.33|2.58|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Asymptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||2.58|0.33|0.8855
91549874|NCT06424236|182981751|OTHER||Hazard Ratio (HR)|0.72||||0.4497|TWO_SIDED|95.0|0.3|1.69|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Symptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||1.69|0.30|0.4497
91549875|NCT06424236|182981752|SUPERIORITY||LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.76|TWO_SIDED|95.0|-0.46|0.33|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with compound symmetry covariance matrix.||0.33|-0.46|0.760
91549876|NCT06424236|182981752|OTHER||LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.715||0.093|TWO_SIDED|95.0|-2.63|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-2.63|0.093
91549877|NCT06424236|182981753|OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.989|TWO_SIDED|95.0|-0.43|0.44|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.44|-0.43|0.989
91549878|NCT06424236|182981753|OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.533||0.714|TWO_SIDED|95.0|-0.86|1.25|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||1.25|-0.86|0.714
91549879|NCT06424236|182981754|OTHER||LS mean|-0.03|STANDARD_ERROR_OF_MEAN|0.077||0.738|TWO_SIDED|95.0|-0.18|0.13|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.13|-0.18|0.738
91766441|NCT00964496|183421864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.02|-2.13||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Comparisons were performed with the use of the independent-samples t test."||-2.13|-4.02|<0.001
91766442|NCT00964496|183421865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.95|||<|0.01|TWO_SIDED|95.0|6.0|9.9||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Comparisons were performed with the use of the independent-samples t test."||9.90|6.00|<0.01
91549880|NCT06424236|182981754|OTHER||LS mean|0.19|STANDARD_ERROR_OF_MEAN|0.222||0.395|TWO_SIDED|95.0|-0.28|0.66|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.66|-0.28|0.395
91549881|NCT06424236|182981755|OTHER||LS mean|-2.176|STANDARD_DEVIATION|2.89551|<|0.0001|TWO_SIDED|95.0|-2.9469|-1.4051|||MMRM|||Week 56: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-1.4051|-2.9469|<0.0001
91766443|NCT00964496|183421866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.0002474|TWO_SIDED|95.0|2.15|6.64||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Comparisons were performed with the use of the independent-samples t test."||6.64|2.15|0.00024740
91549882|NCT06424236|182981755|OTHER||LS mean|-4.8434|STANDARD_DEVIATION|3.78771|<|0.0001|TWO_SIDED|95.0|-5.8609|-3.826|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-3.8260|-5.8609|<0.0001
91549883|NCT06424236|182981755|OTHER||LS mean|-5.762|STANDARD_DEVIATION|3.31129|<|0.0001|TWO_SIDED|95.0|-6.9679|-4.5561|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-4.5561|-6.9679|<0.0001
91549884|NCT06424236|182981756|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.022||0.055|TWO_SIDED|95.0|0.0|0.09|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with variance components covariance matrix.||0.09|0.00|0.055
91549885|NCT06424236|182981756|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.034||0.188|TWO_SIDED|95.0|-0.02|0.11|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.11|-0.02|0.188
91549886|NCT06424236|182981757|OTHER||LS mean|0.0067|STANDARD_DEVIATION|0.0124||0.0001|TWO_SIDED|95.0|0.0034|0.01|||MMRM|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0100|0.0034|0.0001
91549887|NCT06424236|182981757|OTHER||LS mean|0.0251|STANDARD_DEVIATION|0.02262|<|0.0001|TWO_SIDED|95.0|0.0189|0.0312|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0312|0.0189|<0.0001
91549888|NCT06424236|182981757|OTHER||LS mean|0.0357|STANDARD_DEVIATION|0.02467|<|0.0001|TWO_SIDED|95.0|0.0266|0.0447|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0447|0.0266|<0.0001
91766444|NCT00964496|183421867|SUPERIORITY_OR_OTHER||Differences in proportions|-0.374||||0.00298881|TWO_SIDED|95.0|-0.563|-0.185||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||-0.185|-0.563|0.00298881
91549889|NCT06424236|182981758|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.081||0.644|TWO_SIDED|95.0|-0.12|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-0.12|0.644
91549890|NCT06424236|182981758|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.111||0.745|TWO_SIDED|95.0|-0.18|0.26|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.26|-0.18|0.745
91549891|NCT01987895|182981767|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-1.4|||||TWO_SIDED|95.0|-7.2|4.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||4.3|-7.2|
91549892|NCT01987895|182981767|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-2.4|||||TWO_SIDED|95.0|-8.1|3.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||3.2|-8.1|
91549893|NCT01987895|182981768|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-4.1|||||TWO_SIDED|95.0|-9.2|1.0|||||CI for the difference between two proportions are estimated using the Wilson' score method|||1.0|-9.2|
91549894|NCT01987895|182981769|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|3.3|||||TWO_SIDED|95.0|-4.3|10.8|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.8|-4.3|
91549895|NCT01987895|182981770|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6016|TWO_SIDED|95.0|0.8|1.14||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.14|0.80|0.6016
91549896|NCT01987895|182981771|SUPERIORITY||Least Square Mean difference|0.002||||0.9814|TWO_SIDED|95.0|-0.2|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.20|-0.20|0.9814
91549897|NCT01987895|182981771|SUPERIORITY||Least Square Mean difference|0.087||||0.2879|TWO_SIDED|95.0|-0.07|0.25||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.25|-0.07|0.2879
91549898|NCT01987895|182981771|SUPERIORITY||Least Square Mean difference|0.05||||0.488|TWO_SIDED|95.0|-0.09|0.19||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the systemic / other symptoms domain scores||0.19|-0.09|0.4880
91549899|NCT01987895|182981772|OTHER||Difference between 2 proportions|-1.8|||||TWO_SIDED|95.0|-6.5|2.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.9|-6.5|
91549900|NCT01987895|182981773|OTHER||Difference between 2 proportions|-1.9|||||TWO_SIDED|95.0|-6.2|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.3|-6.2|
91549901|NCT01987895|182981774|OTHER||Difference between 2 proportions|3.7|||||TWO_SIDED|95.0|-3.4|10.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||10.7|-3.4|
91549902|NCT01987895|182981775|OTHER|Sensitivity analysis|Difference between 2 proportions|1.1|||||TWO_SIDED|95.0|-6.5|8.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|||8.7|-6.5|
91549903|NCT02547233|182981890|SUPERIORITY||Ratio of clearance rates|30.55|||<|0.001|TWO_SIDED|95.0|4.28|218.0|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||218.0|4.28|<0.001
91549904|NCT02547233|182981891|SUPERIORITY||Ratio of clearance rates|12.26|||<|0.001|TWO_SIDED|95.0|4.73|31.78|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||31.78|4.73|<0.001
91549905|NCT02547233|182981892|SUPERIORITY||Ratio of clearance rates|10.31|||<|0.001|TWO_SIDED|95.0|4.43|23.97|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||23.97|4.43|<0.001
91549906|NCT02547233|182981893|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.37||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.37|0.25|<0.001
91549907|NCT06019559|182981894|SUPERIORITY|||||||0.0756||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|MMRM model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||||||0.0756
91549908|NCT06019559|182981894|SUPERIORITY|||||||0.0008||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|(MMRM) model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||For the primary endpoint of percentage change from baseline in body weight, a sample size of 150 participants (stratified by gender and randomized 1:1:1 into three treatment arms) provided \>95% power to detect a treatment difference of 4% weight reduction after 13 weeks of treatment with a 2-sided alpha of 0.05, assuming a standard deviation of 4% and 20% drop out.||||0.0008
91549909|NCT06019559|182981895|SUPERIORITY|||||||0.8366||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.8366
91549910|NCT06019559|182981895|SUPERIORITY|||||||0.1848||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.1848
91549911|NCT06019559|182981896|SUPERIORITY|||||||0.0616||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0616
91549912|NCT06019559|182981896|SUPERIORITY|||||||0.0004||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0004
91549913|NCT03344094|182981905|OTHER|changes in subsets paired and unpaired t-tests, ANOVA||||||0.05|||||||ANOVA|||||||0.05
91549914|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and gender as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female)."||||0.2
91549915|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||||||Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p\<0.05.|Regression, Logistic|2-factor logistic regression with age and treatment sequence as factors||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years)."||||=0.001
91549916|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and baseline disease severity as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe)."||||0.29
91549917|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and distribution phenotype (localised, widespread) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread)."||||0.55
91549918|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, \>3 mm diameter): p=0.25; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and plaque size as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, \>3 mm diameter)."||||0.25
91549919|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||||||Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, \>0.75 mm) effect: p=0.41; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and skin thickness phenotype as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, \>0.75 mm)."||||0.41
91549920|NCT02310646|182981911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, \>40 years of age) effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and onset phenotype (≤40 years of age, \>40 years of age) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, \>40 years of age)."||||0.20
91549921|NCT02310646|182981912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007).~Threshold for statistical significance: p\<0.05."|Wilcoxon Rank Sum Test|Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.||Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.||||0.007
91549922|NCT02310646|182981913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.||||<0.001
91549923|NCT02310646|182981913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.||||<0.001
91549924|NCT00613106|182981917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4228||95.0|||||Cochran-Mantel-Haenszel|||||||0.4228
91549925|NCT04568603|182981963|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the 90% CI for the geometric mean ratio (GMR) of methadone+ ISL to methadone alone is contained within the interval (0.70, 1.43).|GMR|1.03|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
91549926|NCT04568603|182981964|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
91549927|NCT04568603|182981965|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 1.43.|GMR|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.96|
91766445|NCT00964496|183421868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1557.14|||<|0.01|TWO_SIDED|95.0|1294.53|1819.76||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Comparisons were performed with the use of the independent-samples t test."||1819.76|1294.53|<0.01
91549928|NCT04568603|182981966|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.06|||||TWO_SIDED|90.0|1.03|1.1||||||||1.10|1.03|
91549929|NCT04568603|182981968|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||||1.09|0.94|
91549930|NCT04568603|182981969|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.08|||||TWO_SIDED|90.0|1.04|1.13||||||||1.13|1.04|
91549931|NCT04568603|182981971|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
91549932|NCT04568603|182981972|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
91549933|NCT04568603|182981973|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.07|||||TWO_SIDED|90.0|1.03|1.11||||||||1.11|1.03|
91549934|NCT04564742|182981977|SUPERIORITY||Win Ratio (WR)|1.34|||<|0.001|TWO_SIDED|95.0|1.2|1.5||A closed testing procedure including a pre-specified hierarchical ordering of the primary and secondary endpoints was utilised. No multiplicity control was placed on the exploratory endpoints.|Win Ratio Analysis|||The primary objective of the study was to determine if the clinical benefit of dapagliflozin was superior as compared with placebo, utilizing a hierarchical composite endpoint and win-ratio (WR) method. With a presumed WR of 1.20, 4000 patients were provide an 80% statistical power for the primary endpoint, maintaining a 1:1 allocation between treatments. The primary analysis was based on the intention-to-treat principle using the Full Analysis Set.||1.50|1.20|<0.001
91549935|NCT03313076|182981985|SUPERIORITY||Slope|-0.84||||0.276|TWO_SIDED|95.0|-2.32|0.63||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||0.63|-2.32|0.276
91766446|NCT00964496|183421869|SUPERIORITY_OR_OTHER||Differences in proportions|0.464||||3.962e-05|TWO_SIDED|95.0|0.28|0.649|||Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the cessation of bleeding.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the cessation of bleeding.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.649|0.28|0.00003962
91766447|NCT04308941|183421881|OTHER|The mean and standard deviation was analyzed.||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91549936|NCT03313076|182981985|SUPERIORITY||Slope|0.72||||0.336|TWO_SIDED|95.0|-0.71|2.14||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||2.14|-0.71|0.336
91549937|NCT03313076|182981985|SUPERIORITY||Slope|-2.33||||0.004|TWO_SIDED|95.0|-3.76|-0.9||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||-0.9|-3.76|0.004
91766448|NCT02230566|183421882|SUPERIORITY||LS Mean|-64.82|||<|0.0001|TWO_SIDED|95.0|-69.66|-59.98||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||-59.98|-69.66|< 0.0001
91766449|NCT02230566|183421883|SUPERIORITY|||||||0.0527|||||||t-test|"P value from t-test of no change (0 change) from baseline"||||||0.0527
91766450|NCT02230566|183421884|SUPERIORITY||LS Mean|20.8||||0.2137|TWO_SIDED|95.0|-12.0|53.7||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||53.7|-12.0|0.2137
91766451|NCT02230566|183421887|SUPERIORITY||LS Mean|-6.5||||0.1778|TWO_SIDED|95.0|-16.1|3.0|||GEE|||Shoulder Flexion - Left||3.0|-16.1|0.1778
91549938|NCT03313076|182981985|SUPERIORITY||Slope|0.92||||0.139|TWO_SIDED|95.0|-0.25|2.09||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||2.09|-0.25|0.139
91549939|NCT04137367|182982031|OTHER|||||||0.05|||||||Mixed Models Analysis|||We estimated a priori that a total of 100 participants would be needed to detect a difference between ABM and sham condition, with a two-tailed α of 0.05 and (1-β) of .80. Power calculation was based on the assumption that 50 % of the participants allocated to ABM would report a minimum of 3 points reduction on BDI-II at six months, compared to 20 % in the sham condition. Assuming 15 % lost to follow up, power calculation indicated the need for 50 participants in each condition||||.05
91549940|NCT05448105|182982061|SUPERIORITY|||||||0.02|||||||Wilcoxon signed rank test|"Wilcoxon signed rank test comparing the participants' SUS scores to the threshold value of 71 indicative of good usability."||||||0.02
91549941|NCT05448105|182982064|OTHER|||||||0.04|||||||paired Wilcoxon signed-rank sum test|||||||0.04
91766452|NCT02230566|183421887|SUPERIORITY||LS Mean|-1.5||||0.7632|TWO_SIDED|95.0|-10.9|8.0|||GEE|||Shoulder Extension - Left||8.0|-10.9|0.7632
91766453|NCT02230566|183421887|SUPERIORITY||LS Mean|-1.8||||0.6034|TWO_SIDED|95.0|-8.8|5.1|||GEE|||Shoulder Flexion - Right||5.1|-8.8|0.6034
91766454|NCT02230566|183421887|SUPERIORITY||LS Mean|-3.4||||0.3332|TWO_SIDED|95.0|-10.2|3.4|||GEE|||Shoulder Extension - Right||3.4|-10.2|0.3332
91549942|NCT05448105|182982065|OTHER||||||<|0.01||||||This is calculated p-value. The threshold for significance was less than 0.05.|paired Wilcoxon signed-rank sum test|||||||<0.01
91549943|NCT05448105|182982066|OTHER|||||||0.16|||||||paired Wilcoxon signed-rank sum test|||||||0.16
91549944|NCT05448105|182982067|OTHER|||||||0.69|||||||paired Wilcoxon signed-rank sum test|||||||0.69
91549945|NCT05448105|182982068|OTHER|||||||0.9|||||||paired Wilcoxon signed-rank sum test|||||||0.90
91549946|NCT05448105|182982069|OTHER|||||||0.11|||||||paired Wilcoxon signed-rank sum test|||||||0.11
91549947|NCT05448105|182982070|OTHER|||||||0.22|||||||paired Wilcoxon signed-rank sum test|||||||0.22
91549948|NCT05448105|182982071|OTHER|||||||1||||||This is the calculated p-value.|McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||1.00
91549949|NCT05448105|182982071|OTHER|||||||0.55|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.55
91549950|NCT05448105|182982071|OTHER|||||||0.11|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.11
91549951|NCT05448105|182982071|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.63
91549952|NCT05448105|182982071|OTHER|||||||0.12|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.12
91549953|NCT05448105|182982071|OTHER|||||||0.33|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.33
91549954|NCT05448105|182982071|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in knowledge of definition of urine microalbumin||||0.23
91549955|NCT05448105|182982071|OTHER|||||||0.58|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for urine microalbumin||||0.58
91549956|NCT05448105|182982071|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of body mass index (BMI)||||1.00
91549957|NCT05448105|182982071|OTHER|||||||0.27|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for body mass index (BMI)||||0.27
91549958|NCT05329220|182982177|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.89||||0.635|TWO_SIDED|97.5|0.5|1.57||P-value corresponds to Cohort 1 ABNCoV2 comparison to Cohort 1 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||1.57|0.50|0.6350
91549959|NCT05329220|182982177|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.8||||0.0002|TWO_SIDED|97.5|0.7|0.92||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.92|0.70|0.0002
91549960|NCT05329220|182982178|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.76||||0.0008|TWO_SIDED|97.5|0.64|0.91||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron variant BA.4/BA.5|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.91|0.64|0.0008
91549961|NCT05329220|182982178|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.69|||<|0.0001|TWO_SIDED|97.5|0.59|0.81||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron Variant XBB.1.5.|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.81|0.59|<0.0001
91549962|NCT05651308|182982182|SUPERIORITY||Risk Difference (RD)|0.026||||0.37|TWO_SIDED|95.0|-0.03|0.08|||Chi-squared||Risk difference = Intervention proportion minus control proportion.|||0.08|-0.03|0.37
91549963|NCT00986856|182982186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|13.2|||<|0.01||95.0|1.4|120.4||Test for the hypothesis of odds ratio equal to 1.|Cochran-Mantel-Haenszel|||||120.4|1.4|<0.01
91549964|NCT00986856|182982187|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.7||||0.023||95.0|1.1|28.6|||Cochran-Mantel-Haenszel|||||28.6|1.1|0.023
91549965|NCT00986856|182982188|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.3|8.1|||Cochran-Mantel-Haenszel|||||8.1|0.3|0.54
91549966|NCT00986856|182982189|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7||||0.1|TWO_SIDED|95.0|0.8|8.8|||Cochran-Mantel-Haenszel|||||8.8|0.8|0.1
91549967|NCT00986856|182982190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Cochran-Mantel-Haenszel|||||||0.1
91766455|NCT02230566|183421887|SUPERIORITY||LS Mean|-9.4||||0.0415|TWO_SIDED|95.0|-18.4|-0.4|||GEE|||Tighter Shoulder Flexion||-0.4|-18.4|0.0415
91549968|NCT00986856|182982191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.043||95.0|0.9|83.5|||Cochran-Mantel-Haenszel|||||83.5|0.9|0.043
91549969|NCT00986856|182982192|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.8||||0.007||95.0|1.5|109.6|||Cochran-Mantel-Haenszel|||||109.6|1.5|0.007
91549970|NCT00986856|182982193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|2.0||0.008||95.0|-4.8|-0.8|||Regression, Linear|||||-0.8|-4.8|0.008
91549971|NCT05445427|182982194|SUPERIORITY|Groups were compared using Wilcoxon rank sum test.||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
91549972|NCT05445427|182982195|SUPERIORITY|||||||0.292|||||||ANCOVA|ANCOVA was used with the baseline value used as the covariate.||||||0.292
91549973|NCT04447469|182982211|SUPERIORITY||Odds Ratio (OR)|2.069||||0.2598|TWO_SIDED|95.0|0.555|8.615||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||8.615|0.555|0.2598
91766456|NCT02230566|183421887|SUPERIORITY||LS Mean|-6.7||||0.0563|TWO_SIDED|95.0|-13.6|0.2|||GEE|||Tighter Shoulder Extension||0.2|-13.6|0.0563
91766457|NCT02230566|183421888|SUPERIORITY||LS Mean|1.0||||0.114|TWO_SIDED|95.0|-0.2|2.2|||GEE|||for the left eye||2.2|-0.2|0.1140
91766458|NCT02230566|183421888|SUPERIORITY||LS Mean|0.9||||0.0906|TWO_SIDED|95.0|-0.1|1.8|||GEE|||for the right eye||1.8|-0.1|0.0906
91766459|NCT02230566|183421889|SUPERIORITY||LS Mean|0.8||||0.0883|TWO_SIDED|95.0|-0.1|1.7|||GEE|||Scale-BALANCE||1.7|-0.1|0.0883
91766460|NCT02230566|183421889|SUPERIORITY||LS Mean|-0.2||||0.3528|TWO_SIDED|95.0|-0.7|0.2|||GEE|||Scale: FINE MOTOR PRECISION||0.2|-0.7|0.3528
91766461|NCT02230566|183421889|SUPERIORITY||LS Mean|0.2||||0.4094|TWO_SIDED|95.0|-0.2|0.6|||GEE|||Scale-MANUAL DEXTERITY||0.6|-0.2|0.4094
91766462|NCT02230566|183421889|SUPERIORITY||LS Mean|0.2||||0.102|TWO_SIDED|95.0|0.0|0.4|||GEE|||Scale-RUNNING SPEED AND AGILITY||0.4|0.0|0.1020
91766463|NCT02230566|183421890|SUPERIORITY||LS Mean|3.4||||0.1953|TWO_SIDED|95.0|-1.8|8.6|||GEE|||||8.6|-1.8|0.1953
91766464|NCT02230566|183421892|SUPERIORITY||LS Mean|-1.2||||0.2022|TWO_SIDED|95.0|-3.0|0.6|||GEE|||||0.6|-3.0|0.2022
91766465|NCT03507036|183421907|OTHER||||||||||||||||||A paired t-test was performed for skin lab measurement and biopsies.|||
91766466|NCT03901144|183421924|SUPERIORITY||Mean Difference (Final Values)|-9.026|||<|0.001|TWO_SIDED|95.0|-12.562|-5.489|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.489|-12.562|<0.001
91549974|NCT04447469|182982211|SUPERIORITY||Odds Ratio (OR)|2.414||||0.161|TWO_SIDED|95.0|0.653|9.957||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||9.957|0.653|0.1610
91549975|NCT04447469|182982211|SUPERIORITY||Stratified Odds Ratio|2.091||||0.2448|TWO_SIDED|95.0|0.612|7.144||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||7.144|0.612|0.2448
91549976|NCT04447469|182982211|SUPERIORITY||Stratified Odds Ratio|2.749||||0.1378|TWO_SIDED|95.0|0.756|9.993||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||9.993|0.756|0.1378
91549977|NCT04447469|182982212|SUPERIORITY||Stratified Odds Ratio|1.231||||0.4534|TWO_SIDED|95.0|0.715|2.12||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||2.120|0.715|0.4534
91549978|NCT04447469|182982212|SUPERIORITY||Stratified Odds Ratio|1.097||||0.7414|TWO_SIDED|95.0|0.636|1.891||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.891|0.636|0.7414
91549979|NCT04447469|182982213|SUPERIORITY||Odds Ratio (OR)|0.984||||1|TWO_SIDED|95.0|0.198|4.884|||Fisher Exact|||||4.884|0.198|1.0000
91549980|NCT04447469|182982213|SUPERIORITY||Odds Ratio (OR)|1.286||||1|TWO_SIDED|95.0|0.26|6.417|||Fisher Exact|||||6.417|0.260|1.0000
91549981|NCT04447469|182982214|SUPERIORITY||Difference in Proportion|-15.0|||||TWO_SIDED|95.0|-45.6|15.6|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - placebo.|||15.6|-45.6|
91549982|NCT04447469|182982214|SUPERIORITY||Difference in Proportions|-27.7|||||TWO_SIDED|95.0|-56.4|0.9|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - Placebo .|||0.9|-56.4|
91766467|NCT03901144|183421924|SUPERIORITY||Mean Difference (Final Values)|-4.194||||0.021|TWO_SIDED|95.0|-7.76|-0.629|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-0.629|-7.760|0.021
91766468|NCT03901144|183421924|SUPERIORITY||Mean Difference (Final Values)|-9.021|||<|0.001|TWO_SIDED|95.0|-12.602|-5.44|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.440|-12.602|<0.001
91766469|NCT03901144|183421925|SUPERIORITY||Mean Difference (Final Values)|-3.538|||<|0.001|TWO_SIDED|95.0|-5.114|-1.962|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-1.962|-5.114|<0.001
91766470|NCT03901144|183421925|SUPERIORITY||Mean Difference (Final Values)|-1.748||||0.031|TWO_SIDED|95.0|-3.332|-0.164|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-0.164|-3.332|0.031
91766471|NCT03901144|183421925|SUPERIORITY||Mean Difference (Final Values)|-4.744|||<|0.001|TWO_SIDED|95.0|-6.332|-3.156|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-3.156|-6.332|<0.001
91766472|NCT03901144|183421926|SUPERIORITY||Mean Difference (Final Values)|-19.077||||0.002|TWO_SIDED|95.0|-31.325|-6.829|||ANCOVA|||Summary of Redness-Mexameter change from day 29 to day 31||-6.829|-31.325|0.002
91766473|NCT03901144|183421926|SUPERIORITY||Mean Difference (Final Values)|-4.493||||0.471|TWO_SIDED|95.0|-16.787|7.801|||ANCOVA|||||7.801|-16.787|0.471
91766474|NCT03901144|183421926|SUPERIORITY||Mean Difference (Final Values)|-27.035|||<|0.001|TWO_SIDED|95.0|-39.372|-14.698|||ANCOVA|||Summary of Redness - Mexameter change from day 29 to day 31||-14.698|-39.372|<0.001
91766475|NCT03901144|183421928|SUPERIORITY||Mean Difference (Net)|-0.354|||<|0.001|TWO_SIDED|95.0|-0.558|-0.15|||ANCOVA|||Summary of Visual Redness at day 31||-0.150|-0.558|<0.001
91766476|NCT03901144|183421928|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.392|TWO_SIDED|95.0|-0.292|0.115|||ANCOVA|||Summary of Visual Redness at day 31||0.115|-0.292|0.392
91766477|NCT03901144|183421928|SUPERIORITY||Mean Difference (Final Values)|-0.447|||<|0.001|TWO_SIDED|95.0|-0.652|-0.242|||ANCOVA|||Summary of Visual Redness at day 31||-0.242|-0.652|<0.001
91549983|NCT04447469|182982215|SUPERIORITY|||||||0.6229||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.6229
91549984|NCT04447469|182982215|SUPERIORITY|||||||0.5526||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.5526
91766478|NCT02021565|183421935|SUPERIORITY|||||||0.973||||||alpha = 0.025|ANOVA|Repeated measures||Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.||||0.973
91549985|NCT04447469|182982216|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9426|TWO_SIDED|80.0|0.71|1.46||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.46|0.71|0.9426
91549986|NCT04447469|182982216|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6838|TWO_SIDED|80.0|0.78|1.57||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.57|0.78|0.6838
91549987|NCT04447469|182982217|SUPERIORITY||Odds Ratio (OR)|0.235||||0.0905|TWO_SIDED|95.0|0.023|1.328|||Fisher Exact|||||1.328|0.023|0.0905
91549988|NCT04447469|182982217|SUPERIORITY||Odds Ratio (OR)|0.431||||0.2247|TWO_SIDED|95.0|0.087|1.815|||Fisher Exact|||||1.815|0.087|0.2247
91549989|NCT04447469|182982217|SUPERIORITY||Stratified Odds Ratio|0.191||||0.0623|TWO_SIDED|95.0|0.033|1.114||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.114|0.033|0.0623
91549990|NCT04447469|182982217|SUPERIORITY||Stratified Odds Ratio|0.368||||0.1957|TWO_SIDED|95.0|0.085|1.583||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.583|0.085|0.1957
91549991|NCT04447469|182982218|SUPERIORITY||Hazard Ratio (HR)|1.57||||0.3766|TWO_SIDED|80.0|0.8|3.09||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||3.09|0.80|0.3766
91549992|NCT04447469|182982218|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9209|TWO_SIDED|80.0|0.51|2.16||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||2.16|0.51|0.9209
91549993|NCT04447469|182982219|SUPERIORITY||Stratified Odds Ratio|0.645||||0.1772|TWO_SIDED|95.0|0.34|1.222||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.222|0.340|0.1772
91549994|NCT04447469|182982219|SUPERIORITY||Stratified Odds Ratio|1.029||||0.9269|TWO_SIDED|95.0|0.563|1.881||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.881|0.563|0.9269
91549995|NCT04447469|182982220|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9578|TWO_SIDED|95.0|0.66|1.49||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.49|0.66|0.9578
91549996|NCT04447469|182982220|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5274|TWO_SIDED|95.0|0.76|1.7||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.70|0.76|0.5274
91766479|NCT02021565|183421935|SUPERIORITY|Alpha = .025||||||0.223|||||||ANOVA|||Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.||||0.223
91549997|NCT04447469|182982221|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1336|TWO_SIDED|95.0|0.36|1.15||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age, and ARDS status).|||1.15|0.36|0.1336
91549998|NCT04447469|182982221|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9767|TWO_SIDED|95.0|0.59|1.72||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata ( age, and ARDS status).|||1.72|0.59|0.9767
91549999|NCT04447469|182982222|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.55|3.71|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||3.71|0.55|
91550000|NCT04447469|182982222|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|0.78|4.54|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||4.54|0.78|
91550001|NCT05201079|182982223|SUPERIORITY||Odds Ratio (OR)|2.395||||0.228|TWO_SIDED|97.79|0.54|10.624||Alpha: 0.0221|Regression, Logistic||Numerator: fidaxomicin; denominator: MBK-01|||10.624|0.540|0.228
91766480|NCT02021565|183421936|SUPERIORITY|||||||0.547|||||||ANOVA|||Analysis 1 is for the Veteran care recipient reported task efficacy||||0.547
91550002|NCT05201079|182982229|SUPERIORITY|||||||||||||||||Alpha value used: 0.0221|Statistical analysis using Odds Ratio cannot be performed because there are zero patients with bad progress in MBK-01 group.|||
91550003|NCT05201079|182982230|SUPERIORITY||Score (logrank) test|1.25||||0.3|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.300
91550004|NCT05201079|182982232|SUPERIORITY||Score (logrank) test|0.02||||0.9|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.900
91766481|NCT02021565|183421936|SUPERIORITY|||||||0.891|||||||ANOVA|||Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.||||0.891
91766482|NCT02021565|183421937|SUPERIORITY|||||||0.729|||||||ANOVA|||||||0.729
91766483|NCT01332994|183421952|SUPERIORITY_OR_OTHER|||||||0.1648|TWO_SIDED|||||Exact one-sided binomial test on single proportions with a significance level of alpha equals (=) 0.025. Null hypothesis: Proportion of participants reaching DAS28 remission (\<2.6) at Week 16 is ≤45 percent (%).|Exact one-sided binomial test|||||||0.1648
91550005|NCT05201079|182982243|SUPERIORITY|||||||0.749||||||Main effect of the Group for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.104.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.749
91550006|NCT05201079|182982243|SUPERIORITY|||||||0.62||||||Main effect of the Visit for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.249.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.620
91550007|NCT05201079|182982243|SUPERIORITY|||||||0.16||||||Main effect of the Group x Visit interaction for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 2.024.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.160
91550008|NCT05201079|182982243|SUPERIORITY|||||||0.614||||||Main effect of the Group for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.257.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.614
91550009|NCT05201079|182982243|SUPERIORITY|||||||0.007||||||Main effect of the Visit for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 7.705. Effect size = 0.046.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.007
91550010|NCT05201079|182982243|SUPERIORITY|||||||0.718||||||Main effect of the Group x Visit interaction for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
91550011|NCT05201079|182982243|SUPERIORITY|||||||0.494||||||Main effect of the Group for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.474.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.494
91550012|NCT05201079|182982243|SUPERIORITY|||||||0.339||||||Main effect of the Visit for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.932.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.339
91550013|NCT05201079|182982243|SUPERIORITY|||||||0.38||||||Main effect of the Group x Visit interaction for the General health area of the SF-36 questionnaire. F statistic (1,56) = 0.783.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.380
91550014|NCT05201079|182982243|SUPERIORITY|||||||0.79||||||Main effect of the Group for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.072|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.790
91550015|NCT05201079|182982243|SUPERIORITY|||||||0.498||||||Main effect of the Visit for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.465.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.498
91550016|NCT05201079|182982243|SUPERIORITY|||||||0.023||||||Main effect of the Group x Visit interaction for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 5.490.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.023
91550017|NCT05201079|182982243|SUPERIORITY|||||||0.553||||||Main effect of the Group for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.356.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.553
91550018|NCT05201079|182982243|SUPERIORITY|||||||0.718||||||Main effect of the Visit for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
91550019|NCT05201079|182982243|SUPERIORITY|||||||0.574||||||Main effect of the Group x Visit interaction for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.319.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.574
91550020|NCT05201079|182982243|SUPERIORITY|||||||0.49||||||Main effect of the Group for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 0.482.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.490
91550021|NCT05201079|182982243|SUPERIORITY|||||||0.032||||||Main effect of the Visit for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 4.850|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.032
91766484|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.7559|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cell compartment||||0.7559
91766485|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.8961|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Transitional B-cells||||0.8961
91766486|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.7915|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cells||||0.7915
91766487|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.8081|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Memory B-cells||||0.8081
91766488|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Pre-switch memory B-cells||||0.6574
91766489|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.4553|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Post-switch memory B-cells||||0.4553
91550022|NCT05201079|182982243|SUPERIORITY|||||||0.145||||||Main effect of the Group x Visit interaction for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 2.181.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.145
91550023|NCT05201079|182982243|SUPERIORITY|||||||0.467||||||Main effect of the Group for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.535.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.467
91550024|NCT05201079|182982243|SUPERIORITY|||||||0.1||||||Main effect of the Visit for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 2.795|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.100
91550025|NCT05201079|182982243|SUPERIORITY|||||||0.89||||||Main effect of the Group x Visit interaction for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.019.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.890
91550026|NCT05201079|182982243|SUPERIORITY|||||||0.742||||||Main effect of the Group for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.742
91550027|NCT05201079|182982243|SUPERIORITY||||||<|0.001||||||Main effect of the Visit for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 21.912. Effect size = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||<0.001
91550028|NCT05201079|182982243|SUPERIORITY|||||||0.089||||||Main effect of the Group x Visit interaction for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 2.986.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.089
91550029|NCT04719832|182982256|SUPERIORITY|Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline percent predicted Forced Expiratory Volume in one second (FEV1), and offset of log (total time in the study in years).|Rate Ratio|0.42|||<|0.001|TWO_SIDED|95.0|0.3|0.59|||Negative binomial distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.59|0.30|< 0.001
91550030|NCT04719832|182982257|SUPERIORITY||Difference in Least Square Means|-3.36|||=|0.08|TWO_SIDED|95.0|-7.11|0.39|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group||0.39|-7.11|= 0.080
91550031|NCT04719832|182982258|SUPERIORITY||Difference in Least Square Means|-0.04|||=|0.69|TWO_SIDED|95.0|-0.27|0.18|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.18|-0.27|= 0.690
91766490|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.2215|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgG-positive class-switched B-cells||||0.2215
91766491|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgA-positive class-switched B-cells||||0.8860
91550032|NCT04719832|182982259|SUPERIORITY||Difference in Least Square Means|-0.001|||=|0.991|TWO_SIDED|95.0|-0.089|0.088|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.088|-0.089|= 0.991
91550033|NCT04719832|182982260|SUPERIORITY||Difference in Least Square Means|-0.09|||=|0.65|TWO_SIDED|95.0|-0.5|0.31|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.31|-0.50|= 0.650
91766492|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.8693|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Double-negative B-cells||||0.8693
91766493|NCT01332994|183421988|SUPERIORITY_OR_OTHER|||||||0.9564|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Plasmablasts||||0.9564
91766494|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.9993|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.9993
91766495|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.3596|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.3596
91766496|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.7435|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.7435
91766497|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.7671|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.7671
91550034|NCT04719832|182982261|SUPERIORITY||Difference in Least Square Means|-0.08|||=|0.647|TWO_SIDED|95.0|-0.42|0.26|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.26|-0.42|= 0.647
91550035|NCT04324359|182982263|SUPERIORITY||||||<|0.001|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on the normal approximation test for differences between proportions.||||||<0.001
91550036|NCT04324359|182982264|SUPERIORITY|||||||0.066|||||||Other: z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.066
91550037|NCT04324359|182982265|SUPERIORITY|||||||0.716|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.716
91550038|NCT04324359|182982266|SUPERIORITY|||||||0.528|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level P-value: based on Barnard's exact test for differences between proportions.||||||0.528
91550039|NCT04324359|182982267|SUPERIORITY|||||||0.766|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.766
91550040|NCT04324359|182982268|SUPERIORITY|||||||0.619|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.619
91550041|NCT02618577|182982269|SUPERIORITY||adjusted cause-specific hazard ratio|0.81||||0.15|TWO_SIDED|95.0|0.6|1.08|||Cause-spec. Cox Proport. Hazard model|||||1.08|0.6|0.15
91550042|NCT02618577|182982270|SUPERIORITY||adjusted cause-specific hazard ratio|0.79|||||TWO_SIDED|95.0|0.45|1.39||||||||1.39|0.45|
91766498|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.7912|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.7912
91766499|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.5595|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.5595
91766500|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.3817|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.3817
91766501|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.3623|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.3623
91766502|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.7108|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7108
91766503|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.0639|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.0639
91550043|NCT02618577|182982271|SUPERIORITY||adjusted cause-specific hazard ratio|0.89|||||TWO_SIDED|95.0|0.67|1.18||||||||1.18|0.67|
91550044|NCT02618577|182982272|SUPERIORITY||adjusted cause-specific hazard ratio|1.16||||0.28|TWO_SIDED|95.0|0.88|1.53|||Cause-spec. Cox Proport. Hazard model|||||1.53|0.88|0.28
91550045|NCT02618577|182982273|SUPERIORITY||adjusted cause-specific hazard ratio|2.1||||0.002|TWO_SIDED|95.0|1.3|3.38|||Cause-spec. Cox Proport. Hazard model|||||3.38|1.3|0.002
91550046|NCT02618577|182982274|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L UK Index||0.01|-0.02|
91550047|NCT02618577|182982274|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-1.46|1.38|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L VAS, FU 24months||1.38|-1.46|
91550048|NCT02618577|182982274|SUPERIORITY||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.56|1.09|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|Karnofsky score||1.09|-0.56|
91550049|NCT02618577|182982275|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-1.12|0.87|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q convenience||0.87|-1.12|
91550050|NCT02618577|182982275|SUPERIORITY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-2.6|0.52|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q satisfaction||0.52|-2.60|
91550051|NCT02618577|182982278|SUPERIORITY||adjusted cause-specific hazard ratio|0.51|||||TWO_SIDED|95.0|0.27|0.96||||||||0.96|0.27|
91550052|NCT02618577|182982279|SUPERIORITY||adjusted cause-specific hazard ratio|0.9|||||TWO_SIDED|95.0|0.62|1.31||||||||1.31|0.62|
91550053|NCT05192109|182982280|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
91550054|NCT05192109|182982280|OTHER|||||||0.93||||||This is the p-value for the simple effect of diagnostic group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.93
91766504|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cell compartment||||0.0186
91550055|NCT05192109|182982280|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
91550056|NCT05192109|182982281|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
91550057|NCT05192109|182982281|OTHER|||||||0.22||||||This is the p-value for the simple effect of group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.22
91550058|NCT05192109|182982281|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
91766505|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Transitional B-cells||||0.0050
91766506|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cells||||0.0463
91766507|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.1919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Memory B-cells||||0.1919
91766508|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.3071|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Pre-switch memory B-cells||||0.3071
91766509|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.1714|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Post-switch memory B-cells||||0.1714
91766510|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.1746|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgG-positive class-switched B-cells||||0.1746
91766511|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.1626|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgA-positive class-switched B-cells||||0.1626
91766512|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.6304|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Double-negative B-cells||||0.6304
91766513|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.3449|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Plasmablasts||||0.3449
91766514|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.0919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cell compartment||||0.0919
91766515|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.2189|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Transitional B-cells||||0.2189
91766516|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.1386|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cells||||0.1386
91766517|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.6199|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Memory B-cells||||0.6199
91766518|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.1019|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Pre-switch memory B-cells||||0.1019
91766519|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.4353|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Post-switch memory B-cells||||0.4353
91550059|NCT05835336|182982293|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.45|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91550060|NCT05835336|182982294|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91550061|NCT05835336|182982295|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.55||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91550062|NCT05835336|182982296|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|5.16||||0.032|TWO_SIDED||||||t-test, 2 sided|||||||0.032
91550063|NCT05835336|182982298|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.58||||0.035|TWO_SIDED||||||t-test, 2 sided|||||||0.035
91550064|NCT05835336|182982299|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|-1.13||||0.521|TWO_SIDED||||||t-test, 2 sided|||||||.521
91550065|NCT04489771|182982300|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC risk categories (favorable vs. intermediate or poor).|Difference in Percentage|-0.5||||0.5312|TWO_SIDED|95.0|-14.0|12.9||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan 200 mg minus Belzutifan 120 mg|||12.9|-14.0|0.5312
91550066|NCT04489771|182982301|OTHER||Hazard Ratio (HR)|0.94||||0.3861|TWO_SIDED|95.0|0.63|1.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.40|0.63|0.3861
91550067|NCT04489771|182982303|OTHER|One-sided nominal p-value, difference in percentage and associated 95% CIs were based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate or poor).|Miettinen & Nurminen method|-6.3||||0.7832|TWO_SIDED|95.0|-21.7|9.4|||Miettinen & Nurminen method|||||9.4|-21.7|0.7832
91550068|NCT04489771|182982304|OTHER||Hazard Ratio (HR)|1.11||||0.6448|TWO_SIDED|95.0|0.65|1.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.90|0.65|0.6448
91550069|NCT05292872|182982311|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.143|0.752||1-sided p-values are proportion of bootstrap replicates exceeding null (defined as a HR of 1) in each direction), and the two-tailed p-value is twice the smaller of one-tailed p-values. A two-tailed p-value was calculated for HR using this method.|Nonparametric bootstrap approach|||||0.752|0.143|<.001
91550070|NCT02561585|182982315|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.97|TWO_SIDED|95.0|-12.05|11.65||t-test in a baseline adjusted linear model|t-test, 2 sided|t-test, 2 sided on a 5% level||||11.65|-12.05|0.97
91550071|NCT04059484|182982363|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6437|TWO_SIDED|95.0|0.789|1.4||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of visceral metastasis, prior treatment with CDK4/6 inhibitors and ECOG according to IRT.|Amcenestrant versus PCEM|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures was reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.4|0.789|0.6437
91550072|NCT04292223|182982376|OTHER|Comparison of the 16-week value with the baseline value|Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|8.8|19.3|||Mixed Models Analysis|||||19.3|8.8|<0.0001
91550073|NCT00753545|182982382|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.49|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.49|0.25|<0.00001
91550074|NCT00753545|182982383|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.95|0.55|0.02
91550075|NCT00753545|182982387|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-27.1||||0.03185|TWO_SIDED|95.0|-51.9|-2.4|||ANCOVA|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||LS mean \< 0 favours olaparib||-2.4|-51.9|0.03185
91550076|NCT00753545|182982391|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.47|0.25|<0.00001
91766520|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.3934|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgG-positive class-switched B-cells||||0.3934
91550077|NCT00753545|182982395|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.22|TWO_SIDED|95.0|0.88|1.71|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.71|0.88|0.22
91550078|NCT00753545|182982396|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.75|1.56|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.56|0.75|0.67
91550079|NCT00753545|182982397|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.38|TWO_SIDED|95.0|0.83|1.64|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.64|0.83|0.38
91550080|NCT03839940|182982469|SUPERIORITY||||||<|0.9999|||||||Fisher Exact|||||||< 0.9999
91550081|NCT03839940|182982470|SUPERIORITY|||||||0.3346|||||||Wilcoxon (Mann-Whitney)|||||||0.3346
91550082|NCT03839940|182982486|SUPERIORITY||||||<|0.70361|||||||Fisher Exact|||Female Population.||||< 0.70361
91550083|NCT03839940|182982486|SUPERIORITY||||||<|0.4667|||||||Fisher Exact|||Male population.||||<0.4667
91550084|NCT03839940|182982487|SUPERIORITY||||||<|1|||||||Fisher Exact|||Black or African American population||||<1.0
91550085|NCT03839940|182982487|SUPERIORITY||||||<|1|||||||Fisher Exact|||White population||||<1.0
91550086|NCT03839940|182982488|SUPERIORITY||||||<|1|||||||Fisher Exact|||Not Hispanic or Latino population.||||<1.0
91550087|NCT03839940|182982489|SUPERIORITY||||||<|0.1701|||||||Wilcoxon (Mann-Whitney)|||Female population.||||<0.1701
91766521|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.4196|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgA-positive class-switched B-cells||||0.4196
91550088|NCT03839940|182982489|SUPERIORITY||||||<|0.4811|||||||Wilcoxon (Mann-Whitney)|||Male population.||||<0.4811
91550089|NCT03839940|182982490|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Black or African American Population||||<1.0
91550090|NCT03839940|182982490|SUPERIORITY||||||<|0.5029|||||||Wilcoxon (Mann-Whitney)|||White Population||||<0.5029
91550091|NCT03839940|182982491|SUPERIORITY||||||<|0.295|||||||Wilcoxon (Mann-Whitney)|||Not Hispanic or Latino Population||||<0.2950
91550092|NCT05210608|182982498|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.29|TWO_SIDED|95.0|-0.85|2.18||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the post-treatment assessment.||2.18|-.85|.29
91550093|NCT05210608|182982498|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.45||0.48|TWO_SIDED|95.0|-3.45|5.79||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the 1 month follow up||5.79|-3.45|.48
91550094|NCT05210608|182982499|SUPERIORITY||Mean Difference (Final Values)|37.7|STANDARD_ERROR_OF_MEAN|14.8|=|0.015|TWO_SIDED|95.0|19.9|102.1||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to Post-treatment.||102.10|19.90|=0.015
91550095|NCT05210608|182982499|SUPERIORITY||Mean Difference (Final Values)|17.03|STANDARD_ERROR_OF_MEAN|24.69||0.08|TWO_SIDED|95.0|-14.57|142.57|||t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to 1 month follow-up.||142.57|-14.57|.08
91550096|NCT05210608|182982500|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|3.64||0.9|TWO_SIDED|95.0|-9.86|8.86|||t-test, 2 sided|||We analyzed whether there were significant differences in carbon monoxide ppm from baseline to Post-treatment.||8.86|-9.86|.90
91550097|NCT05210608|182982500|SUPERIORITY||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|11.29||0.32|TWO_SIDED|95.0|-49.42|22.42|||t-test, 2 sided|||We analyzed whether there were significant difference in carbon monoxide ppm from baseline to the 1 month follow-up.||22.42|-49.42|.32
91550098|NCT05210608|182982501|SUPERIORITY||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|4.36||0.18|TWO_SIDED|95.0|-5.1|19.1|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to post-treatment.||19.10|-5.10|.18
91550099|NCT05210608|182982501|SUPERIORITY||Mean Difference (Final Values)|-12.64|STANDARD_ERROR_OF_MEAN|5.14||0.18|TWO_SIDED|95.0|-25.38|7.38|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to the 1 month follow up.||7.38|-25.38|.18
91766522|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.5546|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Double-negative B-cells||||0.5546
91766523|NCT01332994|183421989|SUPERIORITY_OR_OTHER|||||||0.7695|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Plasmablasts||||0.7695
91550100|NCT04963270|182982502|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_DEVIATION|0.44||0.0196|TWO_SIDED|95.0|-1.88|-0.16|||ANCOVA and Conditional Mean Imputation|||||-0.16|-1.88|0.0196
91550101|NCT04963270|182982503|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.41||0.0123|TWO_SIDED|95.0|-1.82|-0.22|||ANCOVA and Conditional Mean Imputation|||||-0.22|-1.82|0.0123
91550102|NCT04963270|182982504|SUPERIORITY||Difference in Response Rate|-12.7||||0.088|TWO_SIDED|95.0|-27.3|1.9|||Cochran-Mantel-Haenszel|||Stratified Analysis||1.9|-27.3|0.088
91550103|NCT04963270|182982505|SUPERIORITY||Difference in Response Rate|-10.5||||0.137|TWO_SIDED|95.0|-24.2|3.3|||Cochran-Mantel-Haenszel|||Stratified Analysis||3.3|-24.2|0.137
91550104|NCT04963270|182982506|SUPERIORITY||Difference in Adjusted Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.6||0.0062|TWO_SIDED|95.0|-2.8|-0.46|||ANCOVA and Conditional Mean Imputation|||||-0.46|-2.80|0.0062
91550105|NCT04963270|182982507|SUPERIORITY||Difference in adjusted Mean|-1.68|STANDARD_ERROR_OF_MEAN|0.57||0.0034|TWO_SIDED|95.0|-2.8|-0.56|||ANCOVA and Conditional Mean Imputation|||||-0.56|-2.80|0.0034
91550106|NCT04963270|182982508|SUPERIORITY||Difference in Adjusted Mean|-1.51|STANDARD_ERROR_OF_MEAN|0.94||0.1094|TWO_SIDED|95.0|-3.36|0.34|||ANCOVA and Conditional Mean Imputation|||||0.34|-3.36|0.1094
91550107|NCT04963270|182982509|SUPERIORITY||Difference in Adjusted Mean|-1.39|STANDARD_ERROR_OF_MEAN|0.85||0.0999|TWO_SIDED|95.0|-3.05|0.27|||ANCOVA and Conditional Mean Imputation|||||0.27|-3.05|0.0999
91550108|NCT04963270|182982510|SUPERIORITY||Difference in Adjusted Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.1||0.0456|TWO_SIDED|95.0|-4.36|-0.04|||ANCOVA and Conditional Mean Imputation|||||-0.04|-4.36|0.0456
91550109|NCT04963270|182982511|SUPERIORITY||Difference in Adjusted Mean|-2.11|STANDARD_ERROR_OF_MEAN|1.02||0.0382|TWO_SIDED|95.0|-4.1|-0.11|||ANCOVA and Conditional Mean Imputation|||||-0.11|-4.10|0.0382
91550110|NCT04963270|182982512|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-18.7||||0.013|TWO_SIDED|95.0|-33.5|-3.9|||Cochran-Mantel-Haenszel|||||-3.9|-33.5|0.013
91550111|NCT04963270|182982513|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-22.0||||0.002|TWO_SIDED|95.0|-36.2|-7.9|||Cochran-Mantel-Haenszel|||||-7.9|-36.2|0.002
91550112|NCT04963270|182982514|SUPERIORITY||Difference in Adjusted Mean|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.57|-1.41|||ANCOVA and Conditional Mean Imputation|||||-1.41|-4.57|0.0002
91550113|NCT04963270|182982515|SUPERIORITY||Difference in Adjusted Mean|-3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-4.47|-1.53|||ANCOVA and Conditional Mean Imputation|||||-1.53|-4.47|<0.0001
91766524|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.6551|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.6551
91766525|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.6905|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.6905
91766526|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.9678|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.9678
91550114|NCT04963270|182982516|SUPERIORITY||Difference in Response Rate|-21.0||||0.004|TWO_SIDED|95.0|-35.4|-6.6|||Cochran-Mantel-Haenszel|||||-6.6|-35.4|0.004
91550115|NCT04963270|182982517|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-19.4||||0.005|TWO_SIDED|95.0|-32.8|-5.9|||Cochran-Mantel-Haenszel|||||-5.9|-32.8|0.005
91766527|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.2080
91766528|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.4778|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.4778
91550116|NCT04963270|182982518|SUPERIORITY||Difference in Response Rate|-1.7||||0.847|TWO_SIDED|95.0|-19.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|-19.4|0.847
91550117|NCT04963270|182982519|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-4.3||||0.441|TWO_SIDED|95.0|-15.4|6.7|||Cochran-Mantel-Haenszel|||||6.7|-15.4|0.441
91550118|NCT04963270|182982520|SUPERIORITY||Difference in Response Rate|8.5||||0.115|TWO_SIDED|95.0|-2.1|19.0|||Cochran-Mantel-Haenszel|||||19|-2.1|0.115
91550119|NCT04963270|182982521|SUPERIORITY|Stratified Analysis|Difference in Response Rate|8.8||||0.077|TWO_SIDED|95.0|-1.0|18.6|||Cochran-Mantel-Haenszel|||||18.6|-1|0.077
91550120|NCT04963270|182982522|SUPERIORITY||Risk Difference|-6.77||||0.1314|TWO_SIDED|95.0|-17.25|3.7|||Cochran-Mantel-Haenszel|||||3.70|-17.25|0.1314
91550121|NCT04963270|182982523|SUPERIORITY|Stratified Analysis|Risk Difference|-5.07||||0.2264|TWO_SIDED|95.0|-14.74|4.61|||Cochran-Mantel-Haenszel|||||4.61|-14.74|0.2264
91550122|NCT04963270|182982524|SUPERIORITY||Difference in Adjusted Mean|3.44|STANDARD_ERROR_OF_MEAN|1.45||0.0179|TWO_SIDED|95.0|0.59|6.29|||ANCOVA and Conditional Mean Imputation|||||6.29|0.59|0.0179
91766529|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.8526|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.8526
91766530|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.7266|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.7266
91766531|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.2011|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.2011
91766532|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.7872|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7872
91766533|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.5377
91550123|NCT04963270|182982525|SUPERIORITY|Stratified Analysis|Difference in Adjusted Mean|3.73|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|1.04|6.42|||ANCOVA and Conditional Mean Imputation|||||6.42|1.04|0.0066
91550124|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.998|TWO_SIDED|95.0|-17.81|17.86|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||17.86|-17.81|0.998
91550125|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.445|TWO_SIDED|95.0|-24.73|10.93||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||10.93|-24.73|0.445
91550126|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.781|TWO_SIDED|95.0|-15.33|20.36||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||20.36|-15.33|0.781
91550127|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.732|TWO_SIDED|95.0|-20.93|14.75||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||14.75|-20.93|0.732
91550128|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.212|TWO_SIDED|95.0|-6.53|29.14||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||29.14|-6.53|0.212
91550129|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-6.44||||0.476|TWO_SIDED|95.0|-24.27|11.39|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||11.39|-24.27|0.476
91550130|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.962|TWO_SIDED|95.0|-17.4|18.26|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||18.26|-17.40|0.962
91550131|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.211|TWO_SIDED|95.0|-6.96|31.16|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||31.16|-6.96|0.211
91550132|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|2.67||||0.782|TWO_SIDED|95.0|-16.4|21.73|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||21.73|-16.40|0.782
91550133|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.129|TWO_SIDED|95.0|-4.34|33.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.78|-4.34|0.129
91550134|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|13.27||||0.171|TWO_SIDED|95.0|-5.8|32.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||32.35|-5.80|0.171
91550135|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|15.56||||0.108|TWO_SIDED|95.0|-3.49|34.62|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||34.62|-3.49|0.108
91550136|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|4.24||||0.661|TWO_SIDED|95.0|-14.83|23.3|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||23.30|-14.83|0.661
91550137|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|14.21||||0.142|TWO_SIDED|95.0|-4.85|33.27|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.27|-4.85|0.142
91550138|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|11.98||||0.216|TWO_SIDED|95.0|-7.08|31.04|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.04|-7.08|0.216
91550139|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|7.38||||0.445|TWO_SIDED|95.0|-11.71|26.48|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||26.48|-11.71|0.445
91550140|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.096|TWO_SIDED|95.0|-2.92|35.19|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||35.19|-2.92|0.096
91550141|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|11.89||||0.22|TWO_SIDED|95.0|-7.19|30.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||30.96|-7.19|0.220
91550142|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|12.71||||0.189|TWO_SIDED|95.0|-6.35|31.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.78|-6.35|0.189
91550143|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-2.67||||0.782|TWO_SIDED|95.0|-21.75|16.41|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||16.41|-21.75|0.782
91550144|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.528|TWO_SIDED|95.0|-12.98|25.18|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||25.18|-12.98|0.528
91550145|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|2.34||||0.795|TWO_SIDED|95.0|-15.45|20.12|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||20.12|-15.45|0.795
91550146|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-6.13||||0.497|TWO_SIDED|95.0|-23.96|11.69|||mean difference|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||11.69|-23.96|0.497
91550147|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|7.44||||0.409|TWO_SIDED|95.0|-10.34|25.21|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.21|-10.34|0.409
91550148|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|7.89||||0.382|TWO_SIDED|95.0|-9.92|25.7|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.70|-9.92|0.382
91550149|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|7.74||||0.39|TWO_SIDED|95.0|-10.05|25.54|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.54|-10.05|0.390
91550150|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-3.72||||0.68|TWO_SIDED|95.0|-21.54|14.1|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||14.10|-21.54|0.680
91550151|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.927|TWO_SIDED|95.0|-16.99|18.65|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||18.65|-16.99|0.927
91550152|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.508|TWO_SIDED|95.0|-11.95|23.98||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 120 minutes post injection||23.98|-11.95|0.508
91550153|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-3.65||||0.688|TWO_SIDED|95.0|-21.66|14.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.35|-21.66|0.688
91550154|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|16.08||||0.079|TWO_SIDED|95.0|-1.88|34.03|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||34.03|-1.88|0.079
91550155|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.323|TWO_SIDED|95.0|-8.96|26.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||26.96|-8.96|0.323
91550156|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|11.23||||0.183|TWO_SIDED|95.0|-5.39|27.85|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||27.85|-5.39|0.183
91550157|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|-2.61||||0.756|TWO_SIDED|95.0|-19.24|14.02|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.02|-19.24|0.756
91766534|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cell compartment||||0.6238
91550158|NCT04802967|182982539|SUPERIORITY||Mean Difference (Final Values)|3.96||||0.638|TWO_SIDED|95.0|-12.68|20.59|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||20.59|-12.68|0.638
91550159|NCT04636528|182982567|EQUIVALENCE|A minimal detectable difference of 11.2 points was selected based on the psychometric properties of the scale. Considering a power of 80%, a 2-sided 0.05 significance level, and a 10% dropout rate, 82 patients would be necessary to detect an 11.2-point difference between the 2 groups.|Median Difference (Net)|-1.8||||0.75|TWO_SIDED|95.0|-13.5|9.8||The threshold for statistical significance was set at 0.05.|quantile mixed-effects model|a robust method on the medians||||9.8|-13.5|0.75
91550160|NCT04636528|182982567|EQUIVALENCE||Odds Ratio (OR)|0.84||||0.71|TWO_SIDED|95.0|0.32|2.16||The threshold for statistical significance was set at 0.05.|Regression, Logistic|||||2.16|0.32|0.71
91766535|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Transitional B-cells||||0.2848
91766536|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cells||||0.6238
91550161|NCT04636528|182982568|EQUIVALENCE||Median Difference (Net)|-0.6||||0.12|TWO_SIDED|95.0|-1.4|-0.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.2|-1.4|0.12
91550162|NCT04636528|182982569|EQUIVALENCE||Median Difference (Net)|-2.2||||0.89|TWO_SIDED|95.0|-34.6|30.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|||||30.2|-34.6|0.89
91550163|NCT04636528|182982570|EQUIVALENCE||Median Difference (Net)|-0.3||||0.51|TWO_SIDED|95.0|-1.0|0.5|||Quantile mixed-effects model|a robust method on the medians||||0.5|-1.0|0.51
91550164|NCT04636528|182982571|EQUIVALENCE||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||<0.001
91550165|NCT04636528|182982572|EQUIVALENCE||Median Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|0.6||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||0.6|-1.5|<.001
91550166|NCT04636528|182982573|EQUIVALENCE||Median Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.5|-1.4|<.001
91550167|NCT04636528|182982574|EQUIVALENCE||Median Difference (Net)|-0.5||||0.27|TWO_SIDED|95.0|-1.3|0.4||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|A robust method on the medians.||||0.4|-1.3|.27
91550168|NCT04636528|182982575|EQUIVALENCE||Difference in proportions|11.8||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
91550169|NCT04636528|182982576|EQUIVALENCE||Mean Difference (Final Values)|12.7|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91550170|NCT04636528|182982577|EQUIVALENCE||Mean Difference (Final Values)|67.7||||0.36|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.36
91550171|NCT04636528|182982578|EQUIVALENCE||Mean Difference (Final Values)|1.62|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91550172|NCT01369355|182982590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.040
91766537|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Pre-switch memory B-cells||||0.2848
91550173|NCT01369355|182982590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.005
91550174|NCT01369355|182982591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.033
91550175|NCT01369355|182982591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.018
91550176|NCT01369355|182982592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.189
91550177|NCT01369355|182982592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.007
91550178|NCT01369355|182982593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.035
91550179|NCT01369355|182982593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.004
91550180|NCT01369355|182982594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.140
91550181|NCT01369355|182982594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.102
91550182|NCT04213872|182982603|OTHER|||||||0.01|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCI 25.4 (14.2) 17.3 (10.5) \*-8.1 (3.7) .01~\*reduction in scores indicate improvement."||||.01
91550183|NCT04213872|182982604|OTHER|||||||0.03|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCA 16.0 (5.1) 19.2 (5.3) 3.2 (0.2) .03||||.03
91550184|NCT04213872|182982605|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogQOL 3.7 (3.8) 1.8 (2.2) \*-1.9 (1.6) .04~\*lower scores signifying better outcomes."||||.04
91766538|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Post-switch memory B-cells||||0.7471
91550185|NCT04213872|182982606|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogOth 1.5 (2.1) 0.2 (0.4) \*-1.3 (1.7) .04~\*lower scores signifying better outcomes."||||.04
91550186|NCT04213872|182982607|OTHER|||||||0.01|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value WAIS-III Letter/Number 10.7 (3.2) 12.7 (2.8) 2.0 (0.4) .01||||.01
91550187|NCT04213872|182982608|OTHER|||||||0.6|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value~WAIS-III Digit Span Forward and Backward 19.2 (4.8) 19.7 (4.4) 0.5 (0.4) .60"||||.60
91550188|NCT04213872|182982609|OTHER|||||||0.03|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value PSQI 1.5 (0.8) 0.9 (0.7) \*-0.6 (0.1) .03~\*Lower scores mean better outcomes."||||.03
91550189|NCT04213872|182982610|OTHER|||||||0.05|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Anxiety 9.2 (7.7) 4.2 (3.7) \*-5.0 (4.0) .05~\*Lower scores mean better outcomes."||||.05
91550190|NCT04213872|182982611|OTHER|||||||0.08|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Depression 4.1 (4.9) 2.0 (3.0) \*-2.1 (1.9) .08~\*Lower scores mean better outcomes."||||.08
91550191|NCT04213872|182982612|OTHER|||||||0.3|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value BDNF 0.11 (0.9) 0.30 (0.7) 0.19 (0.2) .30~Higher scores mean better outcomes."||||.30
91550192|NCT04213872|182982613|OTHER|||||||0.8|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value NF-kB1 171.7 (25.4) 173.7 (21.6) 2.0 (3.8) .80~Higher scores mean better outcomes."||||.80
91550193|NCT04213872|182982614|OTHER|||||||0.61|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value TP53 12.3 (2.7) 13.1 (5.5) 0.8 (2.8) .61||||.61
91550194|NCT03339713|182982615|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.55|1.11|||t-test, 1 sided|||A/Michigan strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.11|0.55|<.001
91550195|NCT03339713|182982615|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.59|1.12|||t-test, 1 sided|||A/Hong Kong strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.12|0.59|<.001
91550196|NCT03339713|182982615|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.77|1.34|||t-test, 1 sided|||B/Brisbane strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.34|0.77|<.001
91550197|NCT03339713|182982615|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.76|1.36|||t-test, 1 sided|||B/Phuket strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.36|0.76|<.001
91550198|NCT05403827|182982625|SUPERIORITY|||||||0.5019|||||||Control-Based Mean Imputation|||||||0.5019
91550199|NCT05403827|182982626|SUPERIORITY|||||||0.2028|||||||Control-Based Mean Imputation|||||||0.2028
91550200|NCT05403827|182982627|SUPERIORITY|||||||0.1914|||||||Control-Based Mean Imputation|||||||0.1914
91550201|NCT05403827|182982628|SUPERIORITY|||||||0.2512|||||||Control-Based Mean Imputation|||||||0.2512
91550202|NCT05403827|182982629|SUPERIORITY|||||||0.7906|||||||Control-Based Mean Imputation|||||||0.7906
91550203|NCT05403827|182982630|SUPERIORITY|||||||0.5343|||||||Control-Based Mean Imputation|||||||0.5343
91550204|NCT05403827|182982631|SUPERIORITY|||||||0.3757|||||||Control-Based Mean Imputation|||||||0.3757
91550205|NCT03381196|182982675|SUPERIORITY|||||||0.0216|||||||Gehan-Wilcoxon test|||||||0.0216
91550206|NCT03628924|182982707|SUPERIORITY||Treatment difference|12.6|||=|0.166|TWO_SIDED|95.0|-4.6|29.8|||Cochran-Mantel-Haenszel|||||29.8|-4.6|= 0.166
91550207|NCT03628924|182982707|SUPERIORITY||Treatment difference|6.6|||=|0.459|TWO_SIDED|95.0|-10.3|23.6|||Cochran-Mantel-Haenszel|||||23.6|-10.3|= 0.459
91550208|NCT01073566|182982729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.24||0.098|TWO_SIDED|95.0|-0.97|0.16|||ANOVA||Finesse versus usual injection device.|A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||0.16|-0.97|0.098
91766539|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgG-positive class-switched B-cells||||0.7471
91766540|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgA-positive class-switched B-cells||||0.3910
91550209|NCT01073566|182982730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.8|-0.17|||ANOVA||Finesse versus usual injection device|This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||-0.17|-0.80|0.004
91550210|NCT01073566|182982731|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.||||<0.001
91550211|NCT05235750|182982743|OTHER||Mean Difference (Net)|0.2||||0.83|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.83
91550212|NCT05235750|182982743|OTHER||Mean Difference (Net)|-0.2||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|||||.91
91550213|NCT05235750|182982744|OTHER||Mean Difference (Net)|-2.1||||0.45|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.45
91550214|NCT05235750|182982744|OTHER||Mean Difference (Net)|-3.3||||0.29|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|||||.29
91550215|NCT05235750|182982744|OTHER||Mean Difference (Net)|0.8||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.46
91550216|NCT05235750|182982744|OTHER||Mean Difference (Net)|0.2||||0.79|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.79
91550217|NCT05235750|182982744|OTHER||Mean Difference (Net)|-2.1||||0.05|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.05
91550218|NCT05235750|182982744|OTHER||Mean Difference (Net)|-2.4||||0.03|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.03
91550219|NCT05235750|182982744|OTHER||Mean Difference (Net)|-0.2||||0.82|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.82
91550220|NCT05235750|182982744|OTHER||Mean Difference (Net)|-0.5||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.58
91550221|NCT05235750|182982744|OTHER||Mean Difference (Net)|-0.8||||0.56|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.56
91550222|NCT05235750|182982744|OTHER||Mean Difference (Net)|-0.7||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.58
91766541|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.8729|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Plasmablasts||||0.8729
91550223|NCT05235750|182982744|OTHER||Mean Difference (Net)|-0.2||||0.58|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.58
91550224|NCT05235750|182982744|OTHER||Mean Difference (Net)|-0.3||||0.34|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\] for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.34
91550225|NCT05235750|182982744|OTHER||Mean Difference (Net)|0.4||||0.27|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.27
91550226|NCT05235750|182982744|OTHER||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.62
91550227|NCT05235750|182982745|OTHER||Mean Difference (Net)|-0.6||||0.76|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.76
91550228|NCT05235750|182982745|OTHER||Mean Difference (Net)|-2.1||||0.19|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|||||.19
91550229|NCT05235750|182982745|OTHER||Mean Difference (Net)|-1.0||||0.35|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.35
91550230|NCT05235750|182982745|OTHER||Mean Difference (Net)|-1.9||||0.99|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.99
91550231|NCT05235750|182982745|OTHER||Mean Difference (Net)|0.4||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.46
91550232|NCT05235750|182982745|OTHER||Mean Difference (Net)|-0.7||||0.24|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.24
91550233|NCT05235750|182982745|OTHER||Mean Difference (Net)|-0.4||||0.55|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.55
91550234|NCT05235750|182982745|OTHER||Mean Difference (Net)|-0.9||||0.8|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.80
91550235|NCT05235750|182982745|OTHER||Mean Difference (Net)|-1.5||||0.34|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.34
91550236|NCT05235750|182982745|OTHER||Mean Difference (Net)|-3.0||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.91
91550237|NCT05235750|182982746|OTHER||Mean Difference (Net)|1.1||||0.14|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.14
91550238|NCT05235750|182982746|OTHER||Mean Difference (Net)|1.2||||0.14|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|||||.14
91550239|NCT05235750|182982746|OTHER||Median Difference (Net)|0.6||||0.32|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.32
91550240|NCT05235750|182982746|OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.20
91550241|NCT03461276|182982784|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|A 1-sided t-test with a significance level of 0.025 was employed.||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)."||||<0.0001
91550242|NCT03461276|182982784|SUPERIORITY|Additional test|||||<|0.0001||||||1-sided|Wilcoxon (Mann-Whitney)|||||||<0.0001
91550243|NCT03461276|182982784|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|2.96|3.34|||ANCOVA|||The average MΔ of anti-Aβ40 antibody signal between the two treatment groups was compared using an ANCOVA model, using the MΔ anti-Aβ40 antibody signal as the dependent variable, baseline anti-Aβ40 antibody signal (OD in ELISA) as covariate and treatment group and amyloid positivity as fixed effects.||3.34|2.96|<0.0001
91550244|NCT03461276|182982784|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|t-test (sensitivity hypothesis). A 1-sided t-test with a significance level of 0.025 was employed.||"1-sided t-test to compare the ABvac40 and placebo groups.~The primary analysis (t-test) was repeated, using the mITT Analysis Set to test the hypothesis:~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) ≤ 1.778~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) \> 1.778 The alternative hypothesis was confirmed."||||<0.0001
91550245|NCT03461276|182982784|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"The change in anti-Aβ40 antibody signal from baseline to each post-baseline efficacy visit was analyzed using a Mixed-Model Repeated Measures (MMRM), using the mITT Analysis Set.~Dependent variable: change from baseline in anti-Aβ40 antibody signal. Fixed effects: treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity. Covariates: baseline anti-Aβ40 antibody signal and baseline age; Repeated measure: measures within-patient at each visit."||||<0.05
91550246|NCT03461276|182982791|OTHER||||||<|0.001|||||||Mixed Models Analysis|||MMRM - Week 50A||||<0.001
91550247|NCT03461276|182982791|OTHER||||||=|0.047|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.047
91550248|NCT03461276|182982792|OTHER||||||=|0.9936|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9936
91550249|NCT03461276|182982792|OTHER||||||=|0.0391||||||MMRM - Week 6A|Mixed Models Analysis|||MMRM - Week 6A||||= 0.0391
91550250|NCT03461276|182982792|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 10A||||< 0.0001
91550251|NCT03461276|182982792|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 14A||||< 0.0001
91550252|NCT03461276|182982792|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
91550253|NCT03461276|182982792|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
91550254|NCT03461276|182982792|OTHER||||||=|0.0299|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0299
91550255|NCT03461276|182982792|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
91550256|NCT03461276|182982792|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
91550257|NCT03461276|182982792|OTHER||||||=|0.1267|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1267
91550258|NCT03461276|182982792|OTHER|MMRM - Week 104A|||||=|0.2477|||||||Mixed Models Analysis|||||||= 0.2477
91550259|NCT03461276|182982793|OTHER||||||=|0.2151|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.2151
91550260|NCT03461276|182982793|OTHER||||||=|0.0169|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.0169
91550261|NCT03461276|182982793|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.0008
91550262|NCT03461276|182982793|OTHER||||||=|0.0002|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0002
91550263|NCT03461276|182982793|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
91550264|NCT03461276|182982793|OTHER||||||=|0.0023|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0023
91550265|NCT03461276|182982793|OTHER||||||=|0.0021|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0021
91550266|NCT03461276|182982793|OTHER||||||=|0.0007|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0007
91550267|NCT03461276|182982793|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.0012
91550268|NCT03461276|182982793|OTHER||||||=|0.0018|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.0018
91550269|NCT03461276|182982793|OTHER||||||=|0.738|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.738
91550270|NCT03461276|182982794|OTHER||||||=|0.7623|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.7623
91550271|NCT03461276|182982794|OTHER||||||=|0.1506|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.1506
91550272|NCT03461276|182982794|OTHER||||||=|0.1071|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.1071
91550273|NCT03461276|182982794|OTHER||||||=|0.0212|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0212
91550274|NCT03461276|182982794|OTHER||||||=|0.0014|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0014
91550275|NCT03461276|182982794|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
91550276|NCT03461276|182982794|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 40A||||< 0.0001
91550277|NCT03461276|182982794|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
91550278|NCT03461276|182982794|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
91550279|NCT03461276|182982794|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 77A||||< 0.0001
91550280|NCT03461276|182982794|OTHER||||||=|0.0251|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0251
91550281|NCT03461276|182982795|OTHER||||||=|0.6515|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.6515
91550282|NCT03461276|182982795|OTHER||||||=|0.7447|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.7447
91550283|NCT03461276|182982795|OTHER||||||=|0.4518|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.4518
91550284|NCT03461276|182982795|OTHER||||||=|0.5416|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.5416
91550285|NCT03461276|182982795|OTHER||||||=|0.3504|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.3504
91550286|NCT03461276|182982795|OTHER||||||=|0.2109|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.2109
91550287|NCT03461276|182982795|OTHER||||||=|0.0049|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0049
91550288|NCT03461276|182982795|OTHER||||||=|0.0498|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0498
91550289|NCT03461276|182982795|OTHER||||||=|0.2181|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2181
91550290|NCT03461276|182982795|OTHER||||||=|0.2087|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2087
91550291|NCT03461276|182982795|OTHER||||||=|0.8599|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8599
91550292|NCT03461276|182982796|OTHER||||||=|0.9469|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9469
91550293|NCT03461276|182982796|OTHER||||||=|0.9063|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.9063
91550294|NCT03461276|182982796|OTHER||||||=|0.3418|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.3418
91550295|NCT03461276|182982796|OTHER||||||=|0.0236|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0236
91550296|NCT03461276|182982796|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0012
91550297|NCT03461276|182982796|OTHER||||||=|0.0004|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0004
91550298|NCT03461276|182982796|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0008
91550299|NCT03461276|182982796|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
91550300|NCT03461276|182982796|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
91550301|NCT03461276|182982796|OTHER||||||=|0.1255|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1255
91550302|NCT03461276|182982796|OTHER||||||=|0.4232|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4232
91550303|NCT03461276|182982797|OTHER||||||=|0.9211|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9211
91550304|NCT03461276|182982797|OTHER||||||=|0.2817|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.2817
91550305|NCT03461276|182982797|OTHER||||||=|0.2984|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.2984
91550306|NCT03461276|182982797|OTHER||||||=|0.8402|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.8402
91550307|NCT03461276|182982797|OTHER||||||=|0.4428|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.4428
91550308|NCT03461276|182982797|OTHER||||||=|0.4156|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.4156
91550309|NCT03461276|182982797|OTHER||||||=|0.8706|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.8706
91550310|NCT03461276|182982797|OTHER||||||=|0.8691|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.8691
91550311|NCT03461276|182982797|OTHER||||||=|0.2188|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2188
91550312|NCT03461276|182982797|OTHER||||||=|0.1448|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1448
91550313|NCT03461276|182982797|OTHER||||||=|0.5004|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5004
91550314|NCT03461276|182982798|OTHER||||||=|0.1058|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1058
91550315|NCT03461276|182982798|OTHER||||||=|0.0922|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0922
91550316|NCT03461276|182982799|OTHER||||||=|0.9313|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.9313
91550317|NCT03461276|182982799|OTHER||||||=|0.2243|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2243
91550318|NCT03461276|182982799|OTHER||||||=|0.0952|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0952
91550319|NCT03461276|182982800|OTHER||||||=|0.3599|||||||Mixed Models Analysis|||MMRM - Week 24A - left||||= 0.3599
91550320|NCT03461276|182982800|OTHER||||||=|0.8913|||||||Mixed Models Analysis|||MMRM - Week 50A - left||||= 0.8913
91550321|NCT03461276|182982800|OTHER||||||=|0.4736|||||||Mixed Models Analysis|||MMRM - Week 104A - left||||= 0.4736
91550322|NCT03461276|182982800|OTHER||||||=|0.9095|||||||Mixed Models Analysis|||MMRM - Week 24A - right||||= 0.9095
91550323|NCT03461276|182982800|OTHER||||||=|0.8744|||||||Mixed Models Analysis|||MMRM - Week 50A - right||||= 0.8744
91550324|NCT03461276|182982800|OTHER||||||=|0.9307|||||||Mixed Models Analysis|||MMRM - Week 104A - right||||= 0.9307
91550325|NCT03461276|182982801|OTHER||||||=|0.3982|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3982
91550326|NCT03461276|182982801|OTHER||||||=|0.7035|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7035
91550327|NCT03461276|182982801|OTHER||||||=|0.6334|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6334
91550328|NCT03461276|182982802|OTHER||||||=|0.2193|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2193
91550329|NCT03461276|182982802|OTHER||||||=|0.5543|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5543
91550330|NCT03461276|182982803|OTHER||||||=|0.7324|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7324
91550331|NCT03461276|182982803|OTHER||||||=|0.1719|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.1719
91550332|NCT03461276|182982804|OTHER||||||=|0.7977|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7977
91550333|NCT03461276|182982804|OTHER||||||=|0.8828|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8828
91550334|NCT03461276|182982805|OTHER||||||=|0.7954|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7954
91550335|NCT03461276|182982805|OTHER||||||=|0.5895|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5895
91550336|NCT03461276|182982806|OTHER||||||=|0.743|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.743
91550337|NCT03461276|182982806|OTHER||||||=|0.832|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.832
91550338|NCT03461276|182982807|OTHER||||||=|0.2283|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2283
91550339|NCT03461276|182982807|OTHER||||||=|0.886|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.886
91550340|NCT03461276|182982808|OTHER||||||=|0.909|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.909
91550341|NCT03461276|182982808|OTHER||||||=|0.8498|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8498
91550342|NCT03461276|182982809|OTHER||||||=|0.8711|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8711
91550343|NCT03461276|182982809|OTHER||||||=|0.1098|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1098
91550344|NCT03461276|182982809|OTHER||||||=|0.6179|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.6179
91550345|NCT03461276|182982809|OTHER||||||=|0.3715|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3715
91550346|NCT03461276|182982810|OTHER||||||=|0.8949|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8949
91550347|NCT03461276|182982810|OTHER||||||=|0.8712|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8712
91550348|NCT03461276|182982810|OTHER||||||=|0.8748|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.8748
91550349|NCT03461276|182982810|OTHER||||||=|0.6402|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6402
91550350|NCT03461276|182982811|OTHER||||||=|0.552|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.552
91550351|NCT03461276|182982811|OTHER||||||=|0.9371|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9371
91550352|NCT03461276|182982811|OTHER||||||=|0.2354|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2354
91550353|NCT03461276|182982811|OTHER||||||=|0.4608|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4608
91550354|NCT03461276|182982812|OTHER||||||=|0.3246|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3246
91550355|NCT03461276|182982812|OTHER||||||=|0.8047|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8047
91550356|NCT03461276|182982812|OTHER||||||=|0.916|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.916
91550357|NCT03461276|182982812|OTHER||||||=|0.9582|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.9582
91550358|NCT03461276|182982813|OTHER||||||=|0.777|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail A||||= 0.777
91550359|NCT03461276|182982813|OTHER||||||=|0.1727|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail A||||= 0.1727
91550360|NCT03461276|182982813|OTHER||||||=|0.0218|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail A||||= 0.0218
91550361|NCT03461276|182982813|OTHER||||||=|0.2789|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail A||||= 0.2789
91550362|NCT03461276|182982813|OTHER||||||=|0.2261|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail B||||= 0.2261
91550363|NCT03461276|182982813|OTHER||||||=|0.9743|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail B||||= 0.9743
91550364|NCT03461276|182982813|OTHER||||||=|0.2556|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail B||||= 0.2556
91550365|NCT03461276|182982813|OTHER||||||=|0.1008|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail B||||= 0.1008
91550366|NCT03461276|182982814|OTHER||||||=|0.6189|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.6189
91550367|NCT03461276|182982814|OTHER||||||=|0.6937|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.6937
91550368|NCT03461276|182982814|OTHER||||||=|0.6981|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6981
91550369|NCT03461276|182982816|OTHER||||||=|0.2863|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2863
91550370|NCT03461276|182982816|OTHER||||||=|0.3703|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3703
91550371|NCT03461276|182982817|OTHER||||||=|0.9663|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9663
91550372|NCT03461276|182982817|OTHER||||||=|0.3843|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3843
91550373|NCT03461276|182982818|SUPERIORITY||||||<|0.0001||||||A 1-sided t-test with a significance level of 0.025 was employed.|t-test, 1 sided|||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)"||||< 0.0001
91550374|NCT03461276|182982818|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91550375|NCT03461276|182982818|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|3.02|3.4|||ANCOVA|||||3.4|3.02|< 0.0001
91550376|NCT05530603|182982828|OTHER|||||||0.009||||||The threshold for statistical significance was p=0.05.|Chi-squared|||||||.009
91550377|NCT05530603|182982829|OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.8||0.73|TWO_SIDED|||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.730
91550378|NCT05530603|182982830|OTHER|||||||0.033||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||.033
91550379|NCT05530603|182982831|OTHER|||||||0.068|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||.068
91550380|NCT05530603|182982832|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|Fisher Exact|||||||.001
91550381|NCT05530603|182982833|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
91550382|NCT05530603|182982834|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
91550383|NCT02043678|182982835|SUPERIORITY||Hazard Ratio (HR)|1.122||||0.2636|TWO_SIDED|95.0|0.917|1.374|||Cox Proportional Hazards Model|||||1.374|0.917|0.2636
91550384|NCT02043678|182982836|SUPERIORITY||Hazard Ratio (HR)|1.151||||0.1194|TWO_SIDED|95.0|0.964|1.374|||Cox Proportional Hazards model|||||1.374|0.964|0.1194
91550385|NCT02043678|182982837|SUPERIORITY||Hazard Ratio (HR)|1.152||||0.1283|TWO_SIDED|95.0|0.96|1.383|||Cox Proportional Hazards Model|||||1.383|0.960|0.1283
91550386|NCT02043678|182982838|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.1669|TWO_SIDED|95.0|0.945|1.389|||Cox Proportional Hazards Model|||||1.389|0.945|0.1669
91550387|NCT02043678|182982839|SUPERIORITY||Hazard Ratio (HR)|1.033||||0.7871|TWO_SIDED|95.0|0.816|1.308|||Cox Proportional Hazards Model|||||1.308|0.816|0.7871
91550388|NCT02043678|182982840|SUPERIORITY||Hazard Ratio (HR)|1.126||||0.2467|TWO_SIDED|95.0|0.921|1.378|||Cox Proportional Hazards Model|||||1.378|0.921|0.2467
91550389|NCT03133546|182982992|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.84|TWO_SIDED|95.0|0.68|1.37||significance level: 5%|Regression, Cox|Univariate Cox for PFS with treatment effect only|The HR for Osimertinib plus Bevacizumab versus Osimertinib alone is provided.|"Assumption: Median PFS with osimertinib 11 months Target: Detect a 36% improvement in PFS (HR=0.64, corresponding to an increase in median PFS to 17.2 months) under osimertinib and bevacizumab (80% power, at one-sided significant level of 5%)~126 events required"||1.37|0.68|0.84
91550390|NCT05034328|182983007|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91550391|NCT05034328|182983008|SUPERIORITY||Hazard Ratio (HR)|1.063||||0.7026|TWO_SIDED|95.0|0.778|1.451|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treament chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.451|0.778|0.7026
91550392|NCT05034328|182983009|SUPERIORITY||Hazard Ratio (HR)|1.078||||0.6322|TWO_SIDED|95.0|0.792|1.469|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.469|0.792|0.6322
91550393|NCT05034328|182983010|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9598|TWO_SIDED|95.0|0.726|1.356|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.356|0.726|0.9598
91550394|NCT05034328|182983011|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1016|TWO_SIDED|95.0|0.945|1.88|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.880|0.945|0.1016
91550395|NCT05034328|182983012|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.3954|TWO_SIDED|95.0|0.83|1.601|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.601|0.830|0.3954
91550396|NCT05034328|182983013|SUPERIORITY||Hazard Ratio (HR)|1.218||||1.218|TWO_SIDED|95.0|0.871|1.703|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.703|0.871|1.218
91550397|NCT05034328|182983014|SUPERIORITY||||||>|0.05|||||||Regression, Logistic|||The impact of the treatment chosen on the risk to develop respiratory complication requiring antibiotic prescription during a 20-day follow-up was analyzed by a multivariate logistic model||||>0.05
91550398|NCT05034328|182983015|SUPERIORITY||Odds Ratio (OR)|0.335||||0.001|TWO_SIDED|95.0|0.174|0.644|||Regression, Logistic|||||0.644|0.174|0.0010
91550399|NCT04898673|182983050|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-6.08|-4.37|||ANOVA|||||-4.37|-6.08|<0.001
91550400|NCT04898673|182983051|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.39||0.67|TWO_SIDED|95.0|-2.31|3.51|||ANOVA|||||3.51|-2.31|0.670
91550401|NCT04898673|182983052|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|1.55||0.026|TWO_SIDED|95.0|-7.0|-0.5|||ANOVA|||||-0.50|-7.00|0.026
91550402|NCT04898673|182983053|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.37||0.411|TWO_SIDED|95.0|-4.02|1.72|||ANOVA|||||1.72|-4.02|0.411
91550403|NCT05239455|182983161|OTHER|The FDA requires one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75%. Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers.|95% Confidence Interval|88.5|||||ONE_SIDED|95.0|72.81||||||A one-sided confidence interval for the proportion of successes was determined using the Clopper-Pearson exact method for a 95% confidence interval.|The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Proportion of successes greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% was calculated.||72.81|
91550404|NCT05239455|182983162|OTHER|The FDA criteria requires LR-RBC mean 24-hour recovery ≥ 75% with standard deviation (SD) ≤ 9%||||||||||||||||The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Mean and standard deviation were calculated.|||
91550405|NCT03701763|182983170|SUPERIORITY||Percentage Adjusted Difference|21.7|||<|0.0001|TWO_SIDED|95.0|11.2|32.1|||Cochran-Mantel-Haenszel|||||32.1|11.2|<0.0001
91550406|NCT03701763|182983171|SUPERIORITY||Percentage Adjusted Difference|29.4|||<|0.0001|TWO_SIDED|95.0|17.8|40.9|||Cochran-Mantel-Haenszel|||||40.9|17.8|<0.0001
91550407|NCT03701763|182983172|SUPERIORITY||Percentage Adjusted Difference|38.4|||<|0.0001|TWO_SIDED|95.0|25.6|51.2|||Cochran-Mantel-Haenszel|||||51.2|25.6|<0.0001
91550408|NCT03701763|182983173|SUPERIORITY||Difference in Least Squares Mean|-26.97|STANDARD_ERROR_OF_MEAN|4.572|<|0.0001|TWO_SIDED|95.0|-35.93|-18.0|||ANCOVA|||||-18.00|-35.93|<0.0001
91550409|NCT03701763|182983174|SUPERIORITY||Difference in Least Squares Mean|-34.77|STANDARD_ERROR_OF_MEAN|6.229|<|0.0001|TWO_SIDED|95.0|-46.99|-22.55|||ANCOVA|||||-22.55|-46.99|< 0.0001
91550410|NCT03701763|182983175|SUPERIORITY||Percentage Adjusted Difference|4.1||||0.5616|TWO_SIDED|95.0|-9.8|18.0|||Cochran-Mantel-Haenszel|||||18.0|-9.8|0.5616
91550411|NCT03701763|182983176|SUPERIORITY||Difference in Least Squares Mean|-1.8||||0.0009|TWO_SIDED|95.0|-2.9|-0.8|||ANCOVA|||||-0.8|-2.9|0.0009
91766542|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.7261|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cell compartment||||0.7261
91550412|NCT02359890|182983207|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with events|2.6|||||TWO_SIDED|95.0|0.7|6.5|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval.|||6.5|0.7|
91766543|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Transitional B-cells||||0.9338
91550413|NCT02359890|182983209|SUPERIORITY_OR_OTHER_LEGACY||Percentage of patient with acute success|96.2|||||TWO_SIDED|95.0|92.0|98.6|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval|||98.6|92.0|
91550414|NCT05260112|182983211|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91550415|NCT05260112|182983212|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91550416|NCT05260112|182983213|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91550417|NCT05260112|182983214|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91550418|NCT05260112|182983215|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91550419|NCT05260112|182983216|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91550420|NCT03031470|182983275|SUPERIORITY|||||||0.688|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.688
91550421|NCT03031470|182983276|SUPERIORITY|||||||0.7|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.700
91550422|NCT03031470|182983277|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Treatment groups were compared for frequency of allograft nonfunction using Fisher exact test||||||>0.999
91550423|NCT03031470|182983278|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
91550424|NCT03031470|182983279|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
91550425|NCT03031470|182983281|SUPERIORITY|||||||0.574|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for degree of allograft steatosis using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.574
91550426|NCT03031470|182983282|SUPERIORITY|||||||0.843|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of cold ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.843
91550427|NCT03031470|182983283|SUPERIORITY|||||||0.701|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of earm ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.701
91550428|NCT03031470|182983293|SUPERIORITY|"General survival and graft survival (graft loss will be qualified as an event for graft survival) within 1 year were presented with Kaplan-Mayer curves and survival time median with 95% CI. Treatment groups will be compared using logrank test."||||||0.416|||||||Log Rank|||||||0.416
91550429|NCT03435614|182983306|OTHER||||||||||||||||||We selected the individual signs and symptoms associated with the presence of OIWS based on a difference of greater than 15 % in the assessments between the group with OIWS and the group not displaying OIWS. This 15 % difference was judged to be of clinical significance. The signs and symptoms which did not meet this difference were not considered (data not available).|||
91550430|NCT02683447|182983308|OTHER|Correlation||||||0.039||||||P \< 0.05 is considered statistically significant.|Pearson correlation|||||||0.039
91550431|NCT02683447|182983309|OTHER|Correlation|||||<|0.01||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS correct score||||<0.01
91550432|NCT02683447|182983309|OTHER|Correlation||||||0.322||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS risk score||||0.322
91550433|NCT03216057|182983358|SUPERIORITY|The sample size was calculated that 130 subjects randomized in a 1:1 fashion between the 2 arms have 85% power to detect a difference of at least 20% in triglyceride percentage changes compared with placebo at week 12, assuming a common standard deviation in percentage change of 35%, a 2-sided α = 0.05, and we add 20% for lost follow-up, finally the number of subjects for each arm was 65.|Mean Difference (Net)|-24.5|||<|0.01|TWO_SIDED|95.0|-32.7|-16.2|||t-test, 2 sided|||||-16.2|-32.7|<0.01
91550434|NCT03216057|182983359|SUPERIORITY||Mean Difference (Net)|-59.9|||<|0.01|TWO_SIDED|95.0|-83.0|-36.8|||t-test, 2 sided|||||-36.8|-83.0|<0.01
91550435|NCT03216057|182983360|SUPERIORITY||Mean Difference (Net)|-9.0||||0.01|TWO_SIDED|95.0|-16.1|-1.9|||t-test, 2 sided|||||-1.9|-16.1|0.01
91766544|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.9074|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cells||||0.9074
91766545|NCT01332994|183421990|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Memory B-cells||||<0.0001
91550436|NCT03216057|182983361|SUPERIORITY||Mean Difference (Net)|-4.9||||0.3|TWO_SIDED|95.0|-15.8|6.05|||t-test, 2 sided|||||6.05|-15.8|0.3
91550437|NCT03216057|182983362|SUPERIORITY||Mean Difference (Net)|-12.4|||<|0.01|TWO_SIDED|95.0|-21.2|-3.5|||t-test, 2 sided|||||-3.5|-21.2|<0.01
91550438|NCT03216057|182983363|SUPERIORITY||Mean Difference (Net)|-2.2||||0.02|TWO_SIDED|95.0|-4.1|-0.3|||t-test, 2 sided|||||-0.3|-4.1|0.02
91550439|NCT03216057|182983364|SUPERIORITY||Mean Difference (Net)|-1.2||||0.6|TWO_SIDED|95.0|-6.3|3.8|||t-test, 2 sided|||||3.8|-6.3|0.6
91550440|NCT03216057|182983365|SUPERIORITY||Mean Difference (Net)|1.9||||0.1|TWO_SIDED|95.0|-0.9|4.9|||t-test, 2 sided|||||4.9|-0.9|0.1
91550441|NCT03216057|182983366|SUPERIORITY||Mean Difference (Net)|13.4|||<|0.01|TWO_SIDED|95.0|5.8|21.0|||t-test, 2 sided|||||21|5.8|<0.01
91550442|NCT03216057|182983367|SUPERIORITY||Mean Difference (Net)|0.8|||<|0.01|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|||||1.2|0.4|<0.01
91550443|NCT03904147|182983380|SUPERIORITY||Win Ratio|1.44||||0.0311|TWO_SIDED||||||Finkelstein-Schoenfeld Method||The Win Ratio provides an estimation of the treatment effect.|||||0.0311
91550444|NCT03904147|182983381|SUPERIORITY|||||||0.0008|||||||exact test|||||||0.0008
91550445|NCT03904147|182983382|SUPERIORITY||||||<|0.0001|||||||Z test|||||||<0.0001
91550446|NCT03904147|182983383|SUPERIORITY||||||<|0.0001|||||||ANCOVA model|||||||<0.0001
91550447|NCT03904147|182983384|SUPERIORITY||||||<|0.0001|||||||Chi-square test|||||||<0.0001
91550448|NCT03904147|182983385|SUPERIORITY|||||||0.2482|||||||ANCOVA model|||||||0.2482
91550449|NCT03904147|182983386|SUPERIORITY||||||<|0.0001|||||||Exact test|||||||<0.0001
91550450|NCT03904147|182983387|SUPERIORITY||||||<|0.0001|||||||Binomial exact method|||||||<0.0001
91550451|NCT03904147|182983388|SUPERIORITY|||||||0.109|||||||normal approximation|||||||0.1090
91550452|NCT03468868|182983397|NON_INFERIORITY|We chose a non-inferiority margin of 10% (or 0.10 feet per second) for this population.|Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|1.1|<|0.01|TWO_SIDED|95.0|-0.14|0.44|||t-test, 2 sided|||||0.44|-0.14|<0.01
91550453|NCT03468868|182983398|SUPERIORITY||Mean Difference (Final Values)|72.46|STANDARD_DEVIATION|384.1||0.16|TWO_SIDED|95.0|-29.56|174.5|||t-test, 2 sided|||||174.5|-29.56|0.16
91550454|NCT03468868|182983399|SUPERIORITY||Mean Difference (Final Values)|-4.71|STANDARD_DEVIATION|24.96||0.13|TWO_SIDED|95.0|-10.84|1.41|||t-test, 2 sided|||||1.41|-10.84|0.13
91550455|NCT03468868|182983400|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_DEVIATION|18.22||0.7|TWO_SIDED|95.0|-3.55|5.32|||t-test, 2 sided|||||5.32|-3.55|0.70
91550456|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|6.71||0.43|TWO_SIDED|95.0|-0.97|2.3|||t-test, 2 sided|||NeuroQOL Anxiety Domain||2.30|-0.97|0.43
91550457|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|6.16||0.75|TWO_SIDED|95.0|-1.26|1.74|||t-test, 2 sided|||NeuroQOL Depression Domain||1.74|-1.26|0.75
91550458|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|7.54||0.35|TWO_SIDED|95.0|-2.71|0.97|||t-test, 2 sided|||NeuroQOL Fatigue Domain||0.97|-2.71|0.35
91550459|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|3.83||0.91|TWO_SIDED|95.0|-0.88|0.99|||t-test, 2 sided|||NeuroQOL Upper Extremity Function Domain||0.99|-0.88|0.91
91550460|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|1.52|STANDARD_DEVIATION|5.44||0.02|TWO_SIDED|95.0|0.2|2.85|||t-test, 2 sided|||NeuroQOL Lower Extremity Function Domain||2.85|0.20|0.02
91550461|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.29|TWO_SIDED|95.0|-2.54|0.76|||t-test, 2 sided|||NeuroQOL Cognitive Function Domain||0.76|-2.54|0.29
91550462|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.11|TWO_SIDED|95.0|-0.26|2.42|||t-test, 2 sided|||NeuroQOL Emotional and Behavioral Dyscontrol Domain||2.42|-0.26|0.11
91550463|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|7.13||0.54|TWO_SIDED|95.0|-1.19|2.28|||t-test, 2 sided|||NeuroQOL Positive Affect and Well-Being Domain||2.28|-1.19|0.54
91550464|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_DEVIATION|5.76||0.41|TWO_SIDED|95.0|-2.0|0.81|||t-test, 2 sided|||NeuroQOL Sleep Disturbance Domain||0.81|-2.00|0.41
91550465|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|6.65||0.63|TWO_SIDED|95.0|-1.22|2.02|||t-test, 2 sided|||NeuroQOL Ability to Participate in Social Roles and Activities Domain||2.02|-1.22|0.63
91550466|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|7.44||0.48|TWO_SIDED|95.0|-1.16|2.47|||t-test, 2 sided|||NeuroQOL Satisfaction with Social Roles and Activities Domain||2.47|-1.16|0.48
91550467|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|5.68||0.92|TWO_SIDED|95.0|-1.32|1.45|||t-test, 2 sided|||NeuroQOL Stigma Domain||1.45|-1.32|0.92
91550468|NCT03468868|182983401|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_DEVIATION|3.45||0.28|TWO_SIDED|95.0|-1.31|0.37|||t-test, 2 sided|||NeuroQOL Communication Domain||0.37|-1.31|0.28
91550469|NCT03468868|182983402|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_DEVIATION|20.63||0.34|TWO_SIDED|95.0|-7.55|2.6|||t-test, 2 sided|||MSIS Physical||2.60|-7.55|0.34
91550470|NCT03468868|182983402|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_DEVIATION|21.37||0.24|TWO_SIDED|95.0|-6.63|3.88|||t-test, 2 sided|||MSIS Psychological||3.88|-6.63|0.24
91550471|NCT03468868|182983403|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_DEVIATION|8.91||0.74|TWO_SIDED|95.0|-1.83|2.56|||t-test, 2 sided|||MFIS Cognitive||2.56|-1.83|0.74
91550472|NCT03468868|182983403|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|8.03||0.04|TWO_SIDED|95.0|-4.07|-0.12|||t-test, 2 sided|||MFIS Physical||-0.12|-4.07|0.04
91550473|NCT03468868|182983403|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|2.17||0.59|TWO_SIDED|95.0|-0.68|0.39|||t-test, 2 sided|||MFIS Psychosocial||0.39|-0.68|0.59
91550474|NCT03468868|182983403|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_DEVIATION|17.0||0.38|TWO_SIDED|95.0|-6.05|2.3|||t-test, 2 sided|||MFIS Total||2.30|-6.05|0.38
91550475|NCT03468868|182983404|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|1.18||0.87|TWO_SIDED|95.0|-0.34|0.29|||t-test, 2 sided|||||0.29|-0.34|0.87
91550476|NCT03468868|182983405|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_DEVIATION|2.21||0.05|TWO_SIDED|95.0|-1.08|0.0|||t-test, 2 sided|||||0.00|-1.08|0.05
91550477|NCT05399459|182983406|SUPERIORITY||Adjusted percentage difference|19.4|||<|0.0001|TWO_SIDED|95.0|12.0|26.8|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||26.8|12.0|<0.0001
91550478|NCT05399459|182983407|SUPERIORITY||Adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.5|30.9|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||30.9|14.5|<0.0001
91550479|NCT05399459|182983408|SUPERIORITY||Adjusted percentage difference|14.8||||0.0011|TWO_SIDED|95.0|5.9|23.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||23.6|5.9|0.0011
91550480|NCT05399459|182983409|SUPERIORITY||Adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|10.1|27.4|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||27.4|10.1|<0.0001
91550481|NCT05399459|182983410|SUPERIORITY||Adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.2|40.3|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||40.3|23.2|<0.0001
91550482|NCT05399459|182983411|SUPERIORITY||Adjusted percentage difference|-19.7|||<|0.0001|TWO_SIDED|95.0|-27.8|-11.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||-11.6|-27.8|<0.0001
91550483|NCT05399459|182983412|SUPERIORITY||Adjusted percentage difference|33.1|||<|0.0001|TWO_SIDED|95.0|24.7|41.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||41.6|24.7|<0.0001
91550484|NCT05399459|182983413|SUPERIORITY||Adjusted percentage difference|10.1||||0.0707|TWO_SIDED|95.0|-0.9|21.1||P-value \> 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||21.1|-0.9|0.0707
91550485|NCT05583578|182983448|SUPERIORITY|||||||0.012||||||The Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.012
91550486|NCT05583578|182983448|OTHER||Cohen's d (effect size)|0.98|||||TWO_SIDED||||||||Effect sizes greater than (d = 0.80) were considered large.|Post-intervention changes in walking speed||||
91550487|NCT05583578|182983449|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.39
91766546|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Pre-switch memory B-cells||||0.9338
91550488|NCT05583578|182983449|SUPERIORITY||Cohen's d (effect size)|0.31|||||TWO_SIDED||||||||Effect sizes ranging from 0.21 to 0.79 were considered moderate, anything ≥0.80 were considered large.|||||
91550489|NCT05825755|182983463|SUPERIORITY|||||||0.252|||||||Wilcoxon (Mann-Whitney)|||||||0.252
91550490|NCT05825755|182983464|SUPERIORITY|||||||1|||||||McNemar|||||||1.0
91550491|NCT05825755|182983465|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||||||0.791
91550492|NCT04103580|182983470|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.005||0.247|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.247
91550493|NCT04103580|182983470|SUPERIORITY||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.004||0.049|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.049
91550494|NCT04103580|182983471|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.004||0.15|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.150
91550495|NCT04103580|182983471|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.635|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.635
91550496|NCT04752709|182983531|OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
91550497|NCT04248725|182983537|SUPERIORITY||Mean Difference (Net)|-2.7||||0.004|TWO_SIDED||||||Mixed Models Analysis|Models were adjusted for sex, baseline severity, and disability condition.||||||0.004
91550498|NCT04248725|182983538|SUPERIORITY||Mean Difference (Net)|0.59|||<|0.001|TWO_SIDED|95.0|0.3|0.88|||Mixed Models Analysis|||||0.88|0.30|<0.001
91550499|NCT04248725|182983539|SUPERIORITY||Mean Difference (Net)|-0.32||||0.29|TWO_SIDED|95.0|-0.61|-0.03|||Mixed Models Analysis|||||-0.03|-0.61|0.29
91766547|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.6515|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Post-switch memory B-cells||||0.6515
91550500|NCT05312008|182983554|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|paired||||||<0.6
91550501|NCT05312008|182983555|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|Paired||||||<0.6
91550502|NCT05312008|182983556|SUPERIORITY||||||<|1|||||||t-test, 2 sided|Paired||||||<1
91550503|NCT05312008|182983557|SUPERIORITY||||||<|0.04|||||||t-test, 2 sided|Paired||||||<0.04
91550504|NCT05312008|182983558|SUPERIORITY||||||<|0.5|||||||t-test, 2 sided|Paired||||||<0.5
91550505|NCT00324805|182983559|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox||Arm II versus Arm I|||1.19|0.82|0.90
91766548|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.8413|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgG-positive class-switched B-cells||||0.8413
91766549|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgA-positive class-switched B-cells||||0.7244
91550506|NCT00324805|182983560|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.86|1.15|||Regression, Cox||Arm II vs. Arm I|||1.15|0.86|0.95
91550507|NCT05698875|182983564|OTHER||Fixed effects parameter|1.0||||0.12|TWO_SIDED|95.0|0.1|1.9||P=0.04 however was adjusted using the Bonferroni correction The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.9|0.1|0.12
91550508|NCT05698875|182983564|OTHER||Fixed effects parameter|-0.58||||0.23|TWO_SIDED|95.0|-1.5|0.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs control meal||0.4|-1.5|0.23
91766550|NCT01332994|183421990|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Double-negative B-cells||||<0.0001
91550509|NCT05698875|182983564|OTHER||Fixed effects parameter|0.24||||0.62|TWO_SIDED|95.0|-0.7|1.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL vs control meal||1.2|-0.7|0.62
91550510|NCT05698875|182983564|OTHER||Fixed effects parameter|1.6||||0.003|TWO_SIDED|95.0|0.7|2.5||Above is adjusted p value using Bonferroni correction. The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs HGLP||2.5|0.7|0.003
91550511|NCT05698875|182983564|OTHER||Fixed effects parameter|0.82||||0.08|TWO_SIDED|95.0|-0.1|1.7||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs MGL meals||1.7|-0.1|0.08
91550512|NCT05698875|182983564|OTHER||Fixed effects parameter|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.2|-1.7|0.12
91550513|NCT05698875|182983565|OTHER||Mean Difference (Final Values)|0.835||||0.08|TWO_SIDED|95.0|-0.1|1.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.8|-0.1|0.08
91550514|NCT05698875|182983565|OTHER||Mean Difference (Final Values)|-0.7||||0.13|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meal vs control meal||0.2|-1.7|0.13
91550515|NCT05698875|182983565|OTHER||Mean Difference (Final Values)|-0.2||||0.68|TWO_SIDED|95.0|-1.2|0.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.8|-1.2|0.68
91550516|NCT05698875|182983565|OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED|95.0|0.7|2.5||The a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||2.5|0.7|<0.01
91550517|NCT05698875|182983565|OTHER||Mean Difference (Final Values)|1.1||||0.06|TWO_SIDED|95.0|0.2|2.0||The a priori threshold for statistical significance p\<0.05 p value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||2.0|0.2|0.06
91550518|NCT05698875|182983565|OTHER||Mean Difference (Final Values)|-0.5||||0.29|TWO_SIDED|95.0|-1.4|0.4||a priori threshold for statistical significance - P\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.4|-1.4|0.29
91550519|NCT05698875|182983566|OTHER||Mean Difference (Final Values)|1.9|||<|0.01|TWO_SIDED|95.0|0.8|3.0||The a priori threshold for statistical significance p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||3.0|0.8|<0.01
91550520|NCT05698875|182983566|OTHER||Mean Difference (Final Values)|-0.3||||0.59|TWO_SIDED|95.0|-1.4|0.8||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.8|-1.4|0.59
91550521|NCT05698875|182983566|OTHER||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.2|1.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.0|-1.2|0.86
91550522|NCT05698875|182983566|OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||3.3|1.2|<0.001
91550523|NCT05698875|182983566|OTHER||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.1||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction did not alter p value|Linear Mixed Model|||HGL vs MGL meals||3.1|1.1|<0.001
91550524|NCT05698875|182983566|OTHER||Mean Difference (Final Values)|-0.1||||0.79|TWO_SIDED|95.0|-1.2|0.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.9|-1.2|0.79
91766551|NCT01332994|183421990|SUPERIORITY_OR_OTHER|||||||0.3848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Plasmablasts||||0.3848
91766552|NCT00731679|183422014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.01
91766553|NCT00731679|183422015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.005
91766554|NCT02412098|183422019|OTHER||Geometric Least Square Mean (GLSM) Ratio|73.54|||||TWO_SIDED|90.0|41.92|129.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||129.01|41.92|
91550525|NCT05698875|182983567|OTHER||Mean Difference (Final Values)|-8.5||||0.31|TWO_SIDED|95.0|-25.0|8.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGL meals vs control meals||8|-25|0.31
91550526|NCT05698875|182983567|OTHER||Mean Difference (Final Values)|-24.4||||0.03|TWO_SIDED|95.0|-41.0|-8.0||A priori threshold for statistical significance is p\<0.05 P adjusted using Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-8|-41|0.03
91550527|NCT05698875|182983567|OTHER||Mean Difference (Final Values)|12.7||||0.14|TWO_SIDED|95.0|-4.1|29.5||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||29.5|-4.1|0.14
91550528|NCT05698875|182983567|OTHER||Mean Difference (Final Values)|17.0||||0.34|TWO_SIDED|95.0|3.1|31.7||A priori threshold P \<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||31.7|3.1|0.34
91550529|NCT05698875|182983567|OTHER||Mean Difference (Final Values)|-19.0||||0.07|TWO_SIDED|95.0|-33.3|-4.7||A priori threshold for statistical significance is p\<0.05 Adjusted P value with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-4.7|-33.3|0.07
91550530|NCT05698875|182983567|OTHER||Mean Difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-51.0|-21.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGLP vs MGL meals||-21.8|-51.0|<0.001
91550531|NCT05698875|182983568|OTHER||Mean Difference (Final Values)|151.0||||0.25|TWO_SIDED|95.0|7.0|294.0||A priori threshold for statistical significance is p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||294|7|0.25
91766555|NCT02412098|183422019|OTHER||GLSM Ratio (%)|127.8|||||TWO_SIDED|90.0|73.57|222.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||222.01|73.57|
91550532|NCT05698875|182983568|OTHER||Mean Difference (Final Values)|-109.0||||0.15|TWO_SIDED|95.0|-256.0|38.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||38|-256|0.15
91550533|NCT05698875|182983568|OTHER||Mean Difference (Final Values)|-30.0||||0.69|TWO_SIDED|95.0|-177.0|117.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||117|-177|0.69
91550534|NCT05698875|182983568|OTHER||Mean Difference (Final Values)|264.0|||<|0.001|TWO_SIDED|95.0|126.0|401.0||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||401|126|<0.001
91550535|NCT05698875|182983568|OTHER||Mean Difference (Final Values)|192.0||||0.02|TWO_SIDED|95.0|56.0|329.0||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||329|56|0.02
91550536|NCT05698875|182983568|OTHER||Mean Difference (Final Values)|-71.0||||0.32|TWO_SIDED|95.0|-211.0|69.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||69|-211|0.32
91550537|NCT05698875|182983569|OTHER||Mean Difference (Final Values)|6.9|||<|0.01|TWO_SIDED|95.0|3.3|10.4||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||10.4|3.3|<0.01
91550538|NCT05698875|182983569|OTHER||Mean Difference (Final Values)|3.5||||0.06|TWO_SIDED|95.0|-0.2|7.2||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||7.2|-0.2|0.06
91550539|NCT05698875|182983569|OTHER||Mean Difference (Final Values)|0.32||||0.86|TWO_SIDED|95.0|-3.3|3.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||3.9|-3.3|0.86
91550540|NCT05698875|182983569|OTHER||Mean Difference (Final Values)|3.4||||0.11|TWO_SIDED|95.0|0.24|6.48||A priori threshold for statistical significance is p\<0.05 P value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||6.48|0.24|0.11
91550541|NCT05698875|182983569|OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.6|9.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs MGL meals||9.8|3.6|<0.001
91550542|NCT05698875|182983569|OTHER||Mean Difference (Final Values)|3.3||||0.13|TWO_SIDED|95.0|0.2|6.5||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGLP vs MGL meals||6.5|0.2|0.13
91550543|NCT05698875|182983570|OTHER||Mean Difference (Final Values)|-34.8||||0.01|TWO_SIDED|95.0|-55.9|-13.6||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meal||-13.6|-55.9|0.01
91550544|NCT05698875|182983570|OTHER||Mean Difference (Final Values)|-1.8||||0.87|TWO_SIDED|95.0|-23.6|19.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||19.9|-23.6|0.87
91550545|NCT05698875|182983570|OTHER||Mean Difference (Final Values)|-4.7||||0.67|TWO_SIDED|95.0|-26.4|17.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||17.0|-26.4|0.67
91550546|NCT05698875|182983570|OTHER||Mean Difference (Final Values)|-33.3||||0.01|TWO_SIDED|95.0|-54.4|-12.2||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||-12.2|-54.4|0.01
91766556|NCT02412098|183422020|OTHER||GLSM Ratio (%)|80.82|||||TWO_SIDED|90.0|45.11|144.79|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.||144.79|45.11|
91550547|NCT05698875|182983570|OTHER||Mean Difference (Final Values)|-31.4||||0.01|TWO_SIDED|95.0|-52.4|-10.4||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-10.4|-52.4|0.01
91550548|NCT05698875|182983570|OTHER||Mean Difference (Final Values)|1.86||||0.87|TWO_SIDED|95.0|-19.7|23.4||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||23.4|-19.7|0.87
91550549|NCT05698875|182983571|OTHER||Mean Difference (Final Values)|34.0||||0.04|TWO_SIDED|95.0|2.0|65.0|||t-test, 2 sided|||Control vs HGL meals||65|2|0.04
91550550|NCT05698875|182983571|OTHER||Mean Difference (Final Values)|6.0||||0.56|TWO_SIDED|95.0|-17.0|30.0|||t-test, 2 sided|||Control vs HGLP meals||30|-17|0.56
91550551|NCT05698875|182983571|OTHER||Mean Difference (Final Values)|12.0||||0.22|TWO_SIDED|95.0|8.0|32.0|||t-test, 2 sided|||Control vs MGL meals||32|8|0.22
91550552|NCT05698875|182983571|OTHER||Mean Difference (Final Values)|38.0||||0.01|TWO_SIDED|95.0|10.0|67.0|||t-test, 2 sided|||HGL vs HGLP meals||67|10|0.01
91550553|NCT05698875|182983571|OTHER||Mean Difference (Final Values)|33.0||||0.03|TWO_SIDED|95.0|4.0|62.0|||t-test, 2 sided|||HGL vs MGL meals||62|4|0.03
91550554|NCT05698875|182983571|OTHER||Mean Difference (Final Values)|-5.0||||0.63|TWO_SIDED|95.0|-29.0|18.0|||t-test, 2 sided|||HGLP vs MGL meals||18|-29|0.63
91550555|NCT05698875|182983572|OTHER||Mean Difference (Final Values)|22.0||||0.16|TWO_SIDED|95.0|10.0|53.0|||t-test, 2 sided|||Control vs HGL meals||53|10|0.16
91550556|NCT05698875|182983572|OTHER||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED|95.0|5.0|46.0|||t-test, 2 sided|||Control vs HGLP meals||46|5|0.11
91766557|NCT02412098|183422020|OTHER||GLSM Ratio (%)|73.52|||||TWO_SIDED|90.0|47.83|113.02||ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.|||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|||113.02|47.83|
91550557|NCT05698875|182983572|OTHER||Mean Difference (Final Values)|19.0||||0.15|TWO_SIDED|95.0|8.0|45.0|||t-test, 2 sided|||Control vs MGL meals||45|8|0.15
91550558|NCT05698875|182983572|OTHER||Mean Difference (Final Values)|44.0|||<|0.01|TWO_SIDED|95.0|16.0|71.0|||t-test, 2 sided|||HGL vs HGLP meals||71|16|<0.01
91550559|NCT05698875|182983572|OTHER||Mean Difference (Final Values)|-7.0||||0.6|TWO_SIDED|95.0|-36.0|21.0|||t-test, 2 sided|||HGL vs MGL meals||21|-36|0.60
91550560|NCT05698875|182983572|OTHER||Mean Difference (Final Values)|29.0||||0.02|TWO_SIDED|95.0|6.0|51.0|||t-test, 2 sided|||HGLP vs MGL meals||51|6|0.02
91550561|NCT05698875|182983573|OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|0.8|2.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal excursion vs Control meal at 30 minutes||2.4|0.8|<0.001
91550562|NCT05698875|182983573|OTHER||Mean Difference (Final Values)|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.2|||Linear Mixed Model|||HGLP meal vs Control meal glucose excursion at 30 minutes||1.2|-0.5|0.38
91550563|NCT05698875|182983573|OTHER||Mean Difference (Final Values)|-0.3||||0.47|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meal excursion vs Control meal at 30 minutes||0.5|-1.1|0.47
91550564|NCT05698875|182983573|OTHER||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.5|2.0||a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meal vs HGLP meal||2.0|0.5|0.01
91550565|NCT05698875|182983573|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.1|2.6||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal vs MGL meals||2.6|1.1|<0.001
91550566|NCT05698875|182983573|OTHER||Mean Difference (Final Values)|0.7||||0.09|TWO_SIDED|95.0|0.1|1.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs MGL meals||1.4|0.1|0.09
91550567|NCT05698875|182983574|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|0.7|3.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||3.0|0.7|<0.001
91550568|NCT05698875|182983574|OTHER||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-1.2|1.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||1.0|-1.2|0.87
91550569|NCT05698875|182983574|OTHER||Mean Difference (Final Values)|-0.4||||0.48|TWO_SIDED|95.0|-1.5|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.7|-1.5|0.48
91550570|NCT05698875|182983574|OTHER||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|1.0|3.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs HGLP meals||3.1|1.0|<0.001
91550571|NCT05698875|182983574|OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||3.4|1.3|<0.001
91550572|NCT05698875|182983574|OTHER||Mean Difference (Final Values)|-0.34||||0.53|TWO_SIDED|95.0|-1.4|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||0.7|-1.4|0.53
91550573|NCT05698875|182983575|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.03|2.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.7|-0.03|0.06
91550574|NCT05698875|182983575|OTHER||Mean Difference (Final Values)|-1.1||||0.13|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.3|-2.5|0.13
91550575|NCT05698875|182983575|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.5|0.82
91550576|NCT05698875|182983575|OTHER||Mean Difference (Final Values)|2.4|||<|0.01|TWO_SIDED|95.0|1.1|3.7||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||3.7|1.1|<0.01
91550577|NCT05698875|182983575|OTHER||Mean Difference (Final Values)|1.5||||0.08|TWO_SIDED|95.0|0.2|2.9||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||2.9|0.2|0.08
91766558|NCT02412098|183422021|OTHER||GLSM Ratio (%)|66.55|||||TWO_SIDED|90.0|53.33|83.04|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||83.04|53.33|
91550578|NCT05698875|182983575|OTHER||Mean Difference (Final Values)|0.9||||0.21|TWO_SIDED|95.0|-0.5|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.5|0.21
91550579|NCT05698875|182983576|OTHER||Mean Difference (Final Values)|0.8||||0.31|TWO_SIDED|95.0|-0.7|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.2|-0.7|0.31
91550580|NCT05698875|182983576|OTHER||Mean Difference (Final Values)|-1.5||||0.05|TWO_SIDED|95.0|-3.0|-0.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||-0.1|-3.0|0.05
91550581|NCT05698875|182983576|OTHER||Mean Difference (Final Values)|0.03||||0.97|TWO_SIDED|95.0|-1.5|1.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.5|-1.5|0.97
91550582|NCT05698875|182983576|OTHER||Mean Difference (Final Values)|2.3|||<|0.01|TWO_SIDED|95.0|1.0|3.6||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||3.6|1.0|<0.01
91550583|NCT05698875|182983576|OTHER||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED|95.0|0.6|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||2.2|0.6|0.27
91550584|NCT05698875|182983576|OTHER||Mean Difference (Final Values)|1.5||||0.12|TWO_SIDED|95.0|0.1|3.0||a priori threshold for statistical significance \<0.05 Adjusted with p value|Linear Mixed Model|||MGL meals vs HGLP meals||3.0|0.1|0.12
91550585|NCT05698875|182983577|OTHER||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.2|-1.5|0.83
91550586|NCT05698875|182983577|OTHER||Mean Difference (Final Values)|-1.5||||0.09|TWO_SIDED|95.0|-2.9|-0.2||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-0.2|-2.9|0.09
91550587|NCT05698875|182983577|OTHER||Mean Difference (Final Values)|-0.2||||0.78|TWO_SIDED|95.0|-1.6|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.6|0.78
91766559|NCT02412098|183422021|OTHER||GLSM Ratio (%)|102.06|||||TWO_SIDED|90.0|83.03|125.45|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||125.45|83.03|
91550588|NCT05698875|182983577|OTHER||Mean Difference (Final Values)|1.4||||0.11|TWO_SIDED|95.0|0.1|2.7||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.7|0.1|0.11
91550589|NCT05698875|182983577|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.1||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGL meals||1.1|-1.5|0.82
91550590|NCT05698875|182983577|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.1|2.6||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.6|-0.1|0.06
91550591|NCT05698875|182983578|OTHER||Mean Difference (Final Values)|0.1||||0.85|TWO_SIDED|95.0|-1.1|1.3||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.3|-1.1|0.85
91550592|NCT05698875|182983578|OTHER||Mean Difference (Final Values)|-1.2||||0.06|TWO_SIDED|95.0|-2.4|0.04||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.04|-2.4|0.06
91550593|NCT05698875|182983578|OTHER||Mean Difference (Final Values)|-0.08||||0.9|TWO_SIDED|95.0|-1.3|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.3|0.90
91550594|NCT05698875|182983578|OTHER||Mean Difference (Final Values)|1.4||||0.05|TWO_SIDED|95.0|0.3|2.5||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.5|0.3|0.05
91550595|NCT05698875|182983578|OTHER||Mean Difference (Final Values)|0.34||||0.55|TWO_SIDED|95.0|-0.8|1.5||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs MGL meals||1.5|-0.8|0.55
91550596|NCT05698875|182983578|OTHER||Mean Difference (Final Values)|1.1||||0.08|TWO_SIDED|95.0|-0.1|2.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.1|0.08
91550597|NCT05977530|182983592|SUPERIORITY||comparison of ranks in Wilcoxon|0.0|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.01
91550598|NCT05692960|182983622|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|FSFI Total, HRI Cohen's d|1.37|||||TWO_SIDED|95.0|0.62|2.1||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for FSFI total, FSFI lubrication, FSFI pain, and FSFI desire subscales. Means and 95% confidence intervals were also calculated.||2.10|.62|
91550599|NCT05692960|182983622|SUPERIORITY||FSFI Total, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.86|2.37||||||||2.37|.86|
91550600|NCT05692960|182983622|SUPERIORITY||FSFI Lubrication, HRI Cohen's d|1.2|||||TWO_SIDED|95.0|0.49|1.87||||||||1.87|.49|
91550601|NCT05692960|182983622|SUPERIORITY||FSFI Lubrication, VVA Cohen's d|1.85|||||TWO_SIDED|95.0|1.02|2.66||||||||2.66|1.02|
91550602|NCT05692960|182983622|SUPERIORITY||FSFI Pain, HRI Cohen's d|0.77|||||TWO_SIDED|95.0|0.16|1.36||||||||1.36|.16|
91550603|NCT05692960|182983622|SUPERIORITY||FSFI Pain, VVA Cohen's d|0.82|||||TWO_SIDED|95.0|0.24|1.38||||||||1.38|.24|
91550604|NCT05692960|182983622|SUPERIORITY||FSFI Desire, HRI Cohen's d|1.15|||||TWO_SIDED|95.0|0.46|1.82||||||||1.82|.46|
91550605|NCT05692960|182983622|SUPERIORITY||FSFI Desire, VVA Cohen's d|1.21|||||TWO_SIDED|95.0|0.55|1.86||||||||1.86|.55|
91550606|NCT05692960|182983623|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|BITS, HRI Cohen's d|1.0|||||TWO_SIDED|95.0|0.34|1.63||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for the BITS. Means and 95% confidence intervals were also calculated.||1.63|.34|
91550607|NCT05692960|182983623|SUPERIORITY||BITS, VVA Cohen's d|0.5|||||TWO_SIDED|95.0|0.03|1.01||||||||1.01|.03|
91766560|NCT02412098|183422022|OTHER||GLSM Ratio (%)|76.24|||||TWO_SIDED|90.0|50.65|114.77|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||114.77|50.65|
91550608|NCT05692960|182983624|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|PROMIS Interest, HRI Cohen's d|1.1|||||TWO_SIDED|95.0|0.41|1.75||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-test for PROMIS interest, lubrication and satisfaction subscales. Means and 95% confidence intervals were also calculated.||1.75|.41|
91550609|NCT05692960|182983624|SUPERIORITY||PROMIS Interest, VVA Cohen's d|0.64|||||TWO_SIDED|95.0|0.09|1.18||||||||1.18|.09|
91550610|NCT05692960|182983624|SUPERIORITY||PROMIS Satisfaction, HRI Cohen's d|1.19|||||TWO_SIDED|95.0|0.45|1.89||||||||1.89|.45|
91550611|NCT05692960|182983624|SUPERIORITY||PROMIS Satisfaction, VVA Cohen's d|0.8|||||TWO_SIDED|95.0|0.13|1.44||||||||1.44|.13|
91550612|NCT05692960|182983624|SUPERIORITY||PROMIS Lubrication, HRI Cohen's d|1.79|||||TWO_SIDED|95.0|0.88|2.67||||||||2.67|.88|
91550613|NCT05692960|182983624|SUPERIORITY||PROMIS Lubrication, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.74|2.5||||||||2.50|.74|
91550614|NCT02675777|182983625|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91550615|NCT02675777|182983626|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
91550616|NCT03819153|182983633|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0001|TWO_SIDED|95.0|0.66|0.88|||Regression, Cox|||Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.||0.88|0.66|0.0001
91550617|NCT00691002|182983655|SUPERIORITY||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.74|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus calcipotriol ointment at Week 8 LOCF (Last Observation Carried Forward).||1.74|0.94|0.11
91550618|NCT00691002|182983655|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.31|2.45|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus hydrocortisone ointment at Week 8 LOCF (Last Observation Carried Forward).||2.45|1.31|<0.001
91766561|NCT02412098|183422022|OTHER||GLSM Ratio (%)|71.06|||||TWO_SIDED|90.0|44.59|113.25|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||113.25|44.59|
91766562|NCT03089580|183422025|SUPERIORITY|Paired, Student's t-test was used to contrast the outcome variable of TBUT in the treated eye versus the sham eye from visit 1 to visit 5. The null hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error probability of 0.05 for the primary outcome assessment. The pattern of change over the 4 treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS version 9.4 statistical software (SAS Institute, Cary, NC) was used.||||||0.3|||||||paired t test|||The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 \& 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.||||0.3
91550619|NCT00691002|182983655|SUPERIORITY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|4.04|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus ointment vehicle at Week 8 LOCF (Last Observation Carried Forward).||4.04|1.80|<0.001
91550620|NCT05778695|182983708|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|-14.0|STANDARD_DEVIATION|22.02||0.875|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.875
91550621|NCT05778695|182983708|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|15.166||0.739|TWO_SIDED|95.0|-16.026|12.026||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|||||12.026|-16.026|0.739
91550622|NCT05778695|182983709|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|0.0|STANDARD_DEVIATION|0.34||0.37|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.37
91550623|NCT04731818|182983718|SUPERIORITY||Mean Difference (Final Values)|0.0001|||<|0.0001|TWO_SIDED|||||analyzed by 1-way repeated measures analysis of variance (ANOVA) with post hoc Tukey multiple comparison test|ANOVA|1 way repeated measures ANOVA||||||<0.0001
91550624|NCT04164888|182983726|SUPERIORITY||Least Square Mean|-84.56|STANDARD_ERROR_OF_MEAN|7.137|<|0.0001|TWO_SIDED|95.0|-98.95|-70.18|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.18|-98.95|<0.0001
91550625|NCT04164888|182983726|SUPERIORITY||Least Square Mean|-80.43|STANDARD_ERROR_OF_MEAN|7.018|<|0.0001|TWO_SIDED|95.0|-94.58|-66.29|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-66.29|-94.58|<0.0001
91550626|NCT04164888|182983726|SUPERIORITY||Least Square Mean|-84.87|STANDARD_ERROR_OF_MEAN|7.009|<|0.0001|TWO_SIDED|95.0|-99.0|-70.75|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.75|-99.00|<0.0001
91550627|NCT04164888|182983727|SUPERIORITY||Least Square Mean|-48.03|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|-63.06|-32.99|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-32.99|-63.06|<0.0001
91550628|NCT04164888|182983727|SUPERIORITY||Least Square Mean|-49.59|STANDARD_ERROR_OF_MEAN|7.396|<|0.0001|TWO_SIDED|95.0|-64.5|34.69|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||34.69|-64.50|<0.0001
91550629|NCT04164888|182983727|SUPERIORITY||Least Square Mean|-51.99|STANDARD_ERROR_OF_MEAN|7.616|<|0.0001|TWO_SIDED|95.0|-67.34|-36.64|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-36.64|-67.34|<0.0001
91550630|NCT05623228|182983735|SUPERIORITY|||||||0||||||"Bonferroni correction p\<.05~F(1.25)=9.17 η=.254 (p\<.05)"|ANOVA|||||||.00
91550631|NCT05623228|182983735|SUPERIORITY|||||||0||||||Bonferroni correction p\<.05 F(2)=7.30 η=.213 (P\<.05)|ANOVA|||||||.00
91766563|NCT03089580|183422026|SUPERIORITY|The p-value results from a test of the hypothesis that the change in OSDI from visit 1 does not differ from zero. Change distributions that met normal distribution test criteria (Shapiro-Wilk p-value \>0.05) were tested with the paired Student's t-test; non-normal change distributions (at visits 2 \& 4) were tested with the non-parametric Wilcoxon signed rank test.||||||0.2026|||||||paired t test|||||||0.2026
91766564|NCT03087513|183422027|SUPERIORITY||||||<|0.01||||||In all cases of motor evoked potential changes, a P-value of 0.05 was considered significant.|Mixed Models Analysis|As the amplitude values were non-normally distributed, the Mann-Whitney U test was performed to compare the two groups.||In total, 40 patients were randomised for the study. Data from 2 patients were excluded as the crossover arm could not be completed due to intraoperative MEP change (n=1) and the equipment malfunction (n=1). The data distributions were tested for normality with the Kolmogorov-Smirnov test.||||<0.01
91766565|NCT03884790|183422052|OTHER|Descriptive statistical analysis|||||||||||||||||Descriptive statistical analysis|||
91766566|NCT04661150|183422084|SUPERIORITY||Treatment difference|23.8||||0.079|TWO_SIDED|90.0|1.3|44.7|||Chi-squared|||||44.7|1.3|0.079
91766567|NCT04661150|183422089|SUPERIORITY||Treatment difference|-4.8||||0.739|TWO_SIDED|90.0|-27.9|18.9|||Chi-squared|||||18.9|-27.9|0.739
91766568|NCT04661150|183422090|SUPERIORITY||Treatment difference|4.8|||>|0.999|TWO_SIDED|90.0|-10.9|21.4|||Fisher Exact|||||21.4|-10.9|>0.999
91766569|NCT00369577|183422096|SUPERIORITY|||||||0.088||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0880
91766570|NCT00369577|183422096|SUPERIORITY|||||||0.0002||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0002
91550632|NCT05623228|182983736|SUPERIORITY|||||||0.04||||||F(2)=3.20, η=.106 Bonferroni Correction p\<.05|ANOVA|||||||.04
91550633|NCT05623228|182983737|SUPERIORITY|||||||0||||||F(1,06)=8,11, η2=.231 Bonferroni correction p\<.05|ANOVA|||||||.00
91550634|NCT05623228|182983738|SUPERIORITY|||||||0.04||||||F(1,19)=4,30, η2=.137 Bonferroni correction p\<0.5|ANOVA|||||||.04
91766571|NCT00369577|183422097|SUPERIORITY|||||||0.0583|||||||Wilcoxon (Mann-Whitney)|||||||0.0583
91766572|NCT00369577|183422097|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91766573|NCT00369577|183422098|SUPERIORITY|||||||0.0067|||||||Wilcoxon (Mann-Whitney)|||||||0.0067
91766574|NCT00369577|183422098|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
91766575|NCT00369577|183422099|SUPERIORITY|||||||0.0076|||||||Fisher Exact|||||||0.0076
91766576|NCT00369577|183422099|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
91766577|NCT04437485|183422121|SUPERIORITY|||||||0.64|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.64
91550635|NCT05623228|182983739|SUPERIORITY|||||||0||||||t (38.70)|t-test, 1 sided|||||||.00
91550636|NCT03365882|182983751|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.44|TWO_SIDED|95.0|0.43|1.45|||Log Rank|||||1.45|0.43|0.44
91550637|NCT03365882|182983753|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
91550638|NCT04828005|182983762|NON_INFERIORITY|Alternative hypothesis: Nalmefene reversal not less than 80% naloxone reversal|||||<|0.0009|||||||Mixed Models Analysis|||||||<0.0009
91550639|NCT05349500|182983845|SUPERIORITY||Mean Difference (Final Values)|-11.0||||0.019|TWO_SIDED|95.0|-20.1|-1.9|||Mixed Models Analysis|||||-1.9|-20.1|0.019
91766578|NCT04437485|183422122|SUPERIORITY|||||||0.046|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.046
91550640|NCT05349500|182983846|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.286|TWO_SIDED|95.0|-14.1|4.3|||Mixed Models Analysis|||||4.3|-14.1|0.286
91550641|NCT05349500|182983847|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.046|TWO_SIDED|95.0|-4.0|0.0|||Mixed Models Analysis|||||-0.0|-4.0|0.046
91550642|NCT05349500|182983848|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.128|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||||0.5|-3.8|0.128
91550643|NCT05349500|182983849|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.031|TWO_SIDED|95.0|-14.3|-0.7|||Mixed Models Analysis|||||-0.7|-14.3|0.031
91766579|NCT04437485|183422123|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.09
91766580|NCT00181363|183422159|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91766581|NCT00181363|183422160|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91766582|NCT00181363|183422161|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91766583|NCT00181363|183422162|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91766584|NCT00181363|183422163|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91766585|NCT01276639|183422169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.46|||<|0.0001|TWO_SIDED|95.0|4.4|15.03||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||15.03|4.40|<0.0001
91766586|NCT01276639|183422169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.45|||<|0.0001|TWO_SIDED|95.0|9.01|31.88||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||31.88|9.01|<0.0001
91766587|NCT01276639|183422169|SUPERIORITY_OR_OTHER||Percent difference|17.29|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|10.11|24.47|||Normal approximation|||||24.47|10.11|<0.0001
91550644|NCT05349500|182983850|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.564|TWO_SIDED|95.0|-8.8|4.9|||Mixed Models Analysis|||||4.9|-8.8|0.564
91550645|NCT05349500|182983851|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.349|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.349
91550646|NCT05349500|182983852|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.303
91550647|NCT05349500|182983853|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.507|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.2|-0.1|0.507
91550648|NCT05349500|182983854|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.729|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||||0.2|-0.2|0.729
91550649|NCT05349500|182983855|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.421|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.421
91550650|NCT05349500|182983856|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.648|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.648
91550651|NCT05349500|182983857|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.034|TWO_SIDED|95.0|0.3|6.5|||Mixed Models Analysis|||||6.5|0.3|0.034
91550652|NCT05349500|182983858|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.315|TWO_SIDED|95.0|-2.1|6.3|||Mixed Models Analysis|||||6.3|-2.1|0.315
91550653|NCT05349500|182983859|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.444|TWO_SIDED|95.0|-21.5|48.2|||Mixed Models Analysis|||||48.2|-21.5|0.444
91550654|NCT05349500|182983860|SUPERIORITY||Mean Difference (Final Values)|9.3||||0.638|TWO_SIDED|95.0|-30.6|49.2|||Mixed Models Analysis|||||49.2|-30.6|0.638
91550655|NCT05349500|182983861|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.688|TWO_SIDED|95.0|-13.4|8.9|||Mixed Models Analysis|||||8.9|-13.4|0.688
91550656|NCT05349500|182983862|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.709|TWO_SIDED|95.0|-2.5|1.7|||Mixed Models Analysis|||||1.7|-2.5|0.709
91550657|NCT05349500|182983863|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.089|TWO_SIDED|95.0|-3.3|0.2|||Mixed Models Analysis|||||0.2|-3.3|0.089
91550658|NCT05349500|182983864|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.066|TWO_SIDED|95.0|-1.0|30.8|||Mixed Models Analysis|||||30.8|-1.0|0.066
91550659|NCT04413708|182983915|SUPERIORITY||Risk Ratio (RR)|1.62||||0.41|TWO_SIDED|95.0|0.5|5.17|||Fisher Exact|||||5.17|0.50|0.41
91550660|NCT04413708|182983916|SUPERIORITY||Risk Ratio (RR)|1.07||||1|TWO_SIDED|95.0|0.61|1.9|||Fisher Exact|||||1.90|0.61|1.0
91550661|NCT06044090|182983922|SUPERIORITY|||||||0.856|||||||t-test, 2 sided|||||||0.856
91550662|NCT06044090|182983922|SUPERIORITY|||||||0.613|||||||t-test, 2 sided|||||||0.613
91550663|NCT06044090|182983923|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91550664|NCT06044090|182983923|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|||||||0.691
91550665|NCT06044090|182983924|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
91550666|NCT06044090|182983924|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
91550667|NCT02969707|182983944|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|2-sample t-test||Examining the Change in sum of positive z-transformed CC.||||0.035
91550668|NCT02969707|182983944|SUPERIORITY|||||||0.7||||||2-sample t-test|t-test, 2 sided|||Examining the change in sum of all z-transformed CC.||||0.7
91550669|NCT02969707|182983944|SUPERIORITY|2-sample t-test||||||0.11|||||||t-test, 2 sided|||Examining the change in sum of negative z-transformed CC.||||0.11
91550670|NCT02969707|182983944|SUPERIORITY||Mean Difference (Net)|61.98||||0.008|TWO_SIDED||||||t-test, 2 sided|One sample(paired) t-test||Examining the change in positive functional connectivity between the L-DLPFC and the dACC within the active group from pre to post TMS.||||0.008
91550671|NCT02969707|182983946|OTHER||Mann-Whitney U statistic|601.0||||0.046|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||0.046
91550672|NCT02969707|182983946|OTHER||Cohen's R|0.25|||||TWO_SIDED||||||||Estimate of effect size|Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||
91550673|NCT02969707|182983947|SUPERIORITY|We assessed the superiority of active over sham.|Mann-Whitney U statistic|702.5|||=|0.412|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Pre- to post-rTMS change in HIS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.412
91550674|NCT02969707|182983950|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|2-sample t-test||||||0.037
91550675|NCT02969707|182983950|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
91550676|NCT02969707|182983950|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
91550677|NCT02969707|182983955|SUPERIORITY|We assessed the superiority of active over sham.|Cohen's d|-0.234||||0.49|TWO_SIDED||||||Mixed-effects model|||We used standard mixed-effects modeling to estimate the change (slope) in pain in our 2\*2 pre- and post-assessment design. Pain ratings were calculated by averaging pain ratings across 5 assessments under four conditions (TMS with hypnosis, TMS without hypnosis, Sham with hypnosis, Sham without hypnosis). Based on these change estimates, we derived the two main effects (TMS, Hypnosis) and their interaction effect on the change in pain from the pre- to post-treatment assessment.||||0.49
91550678|NCT02969707|182983956|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.454|||||||t-test, 2 sided|||Pre- to post-rTMS change in SOARS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.454
91550679|NCT02969707|182983957|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.023|||||||Regression, Linear|(R² = .104, F(2,48) = 2.794, β = .320, p = .023)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to water was assessed.||||0.023
91550680|NCT02969707|182983957|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.043|||||||Regression, Linear|(R² = .081, F(1,49) = 4.315, β = .284, p = .043)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to water was assessed.||||0.043
91550681|NCT02969707|182983957|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.022|||||||Regression, Linear|(R² = .103, F(1,49) = 5.632, β = .321, p = .022)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to creatine was assessed.||||0.022
91550682|NCT02969707|182983957|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.041|||||||Regression, Linear|(R² = .083, F(1,49) = 4.425, β = .288, p = .041)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to creatine was assessed.||||0.041
91550683|NCT02969707|182983963|SUPERIORITY|||||||0.728|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to creatine is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to creatine.||||0.728
91550684|NCT02969707|182983963|SUPERIORITY|||||||0.72|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to water is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to water.||||0.720
91766588|NCT01276639|183422170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.93|||<|0.0001|TWO_SIDED|95.0|5.25|21.84||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||21.84|5.25|<0.0001
91766589|NCT01276639|183422170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.81|||<|0.0001|TWO_SIDED|95.0|11.9|49.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||49.86|11.90|<0.0001
91766590|NCT01276639|183422170|SUPERIORITY_OR_OTHER||Percent difference|19.22|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|12.07|26.37|||Normal approximation|||||26.37|12.07|<0.0001
91766591|NCT01276639|183422171|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-53.56|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-62.08|-45.04||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-45.04|-62.08|<0.0001
91766592|NCT01276639|183422171|SUPERIORITY_OR_OTHER||LS mean difference|-68.82|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-77.33|-60.31||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-60.31|-77.33|<0.0001
91766593|NCT01276639|183422171|SUPERIORITY_OR_OTHER||LS mean difference|-15.26|STANDARD_ERROR_OF_MEAN|3.46|<|0.0001|TWO_SIDED|95.0|-22.04|-8.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-8.48|-22.04|<0.0001
91766594|NCT01276639|183422172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.55|||<|0.0001|TWO_SIDED|95.0|7.46|1786.9||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||1786.9|7.46|<0.0001
91766595|NCT01276639|183422172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|98.05|||<|0.0001|TWO_SIDED|95.0|23.49|5689.8||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||5689.8|23.49|<0.0001
91766596|NCT01276639|183422172|SUPERIORITY_OR_OTHER||Percent difference|19.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|13.1|26.11|||Normal approximation|||||26.11|13.10|<0.0001
91550685|NCT06074172|182983972|OTHER|Linear Mixed Models were done with a compound symmetry covariance structure. This infers that the variances (pooled within-group) and covariances (across subjects) of all of the repeated measures are homogenous.||||||0.008||||||In the Bonferroni corrected Linear Mixed Model for PI Ratio, the p-value for the following interaction was reported: Treatment\*Age.|Linear Mixed Model|"Linear Mixed Model analyses:~1. Factor: Treatment group~2. Covariates: Age, Sex, CBD Use history, and Urine THC~3. Interactions"||||||0.008
91550686|NCT02714257|182983987|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.74|1.14|||Regression, Cox||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.14|0.74|0.43
91550687|NCT02714257|182983988|SUPERIORITY||Incidence Rate Ratio|1.06||||0.5|TWO_SIDED|95.0|0.89|1.28|||Regression, Negative Binomial||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.28|0.89|0.50
91550688|NCT02714257|182983989|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3|TWO_SIDED|95.0|0.72|1.11|||Regression, Logistic|||||1.11|0.72|0.30
91550689|NCT02714257|182983990|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.01|TWO_SIDED|95.0|0.16|0.92|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.92|0.16|<0.01
91550690|NCT02714257|182983991|SUPERIORITY||Odds Ratio (OR)|1.04||||0.73|TWO_SIDED|95.0|0.85|1.27|||Regression, Logistic||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.27|0.85|0.73
91550691|NCT02714257|182983992|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.27|TWO_SIDED|95.0|-0.18|0.62|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.62|-0.18|0.27
91550692|NCT02714257|182983993|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.37|TWO_SIDED|95.0|-0.13|0.34|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.34|-0.13|0.37
91550693|NCT02714257|182983994|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.26|TWO_SIDED|95.0|-0.1|0.38|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.38|-0.10|0.26
91550694|NCT02714257|182983995|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.39|TWO_SIDED|95.0|-0.09|0.22|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.22|-0.09|0.39
91550695|NCT03656510|182984112|OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.382|0.185||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.185|-1.382|
91550696|NCT03656510|182984112|OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-1.19|0.418||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.418|-1.190|
91550697|NCT03656510|182984112|OTHER||Mean Difference (Final Values)|-2.46|||||TWO_SIDED|95.0|-4.674|-0.25||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.250|-4.674|
91550698|NCT03656510|182984112|OTHER||Mean Difference (Final Values)|-2.38|||||TWO_SIDED|95.0|-4.645|-0.114||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.114|-4.645|
91550699|NCT03974178|182984215|OTHER|"The minimal sample size to get a possible rejection of H0 (pdeath = 8.5% or more) in favour of H1 (pdeath \<8.5%) was 34 evaluable patients with stage 2 r-HAT.~The hypothesis was tested with a one-sided exact test for proportions at the 0.05 significance level."|Fatality rate|0.0||||0.0488|TWO_SIDED|90.0|0.0|8.43||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||8.43|0|0.0488
91550700|NCT03974178|182984216|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0405|TWO_SIDED|90.0|0.0|8.43||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||8.43|0|0.0405
91550701|NCT03974178|182984217|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.94||||0.073|TWO_SIDED|90.0|0.15|13.21||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||13.21|0.15|0.0730
91550702|NCT03974178|182984220|OTHER|The hypothesis H0 (pdeath = 8.5% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Fatality rate|0.0||||0.0201|TWO_SIDED|90.0|0.0|6.58||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||6.58|0|0.0201
91550703|NCT03974178|182984221|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0158|TWO_SIDED|90.0|0.0|6.58||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||6.58|0|0.0158
91550704|NCT03974178|182984222|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.27||||0.0253|TWO_SIDED|90.0|0.12|10.34||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||10.34|0.12|0.0253
91550705|NCT03899259|182984226|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|2.79|22.17|||Regression, Logistic|||||22.17|2.79|<0.001
91550706|NCT03899259|182984226|SUPERIORITY||Odds Ratio (OR)|19.72|||<|0.001|TWO_SIDED|95.0|7.3|53.3|||Regression, Logistic|||||53.30|7.30|<0.001
91550707|NCT03899259|182984227|SUPERIORITY||Mean Difference (Final Values)|-25.25|STANDARD_ERROR_OF_MEAN|3.834|<|0.001|TWO_SIDED|95.0|-32.78|-17.72|||ANCOVA|||||-17.72|-32.78|<0.001
91550708|NCT03899259|182984227|SUPERIORITY||Mean Difference (Final Values)|-44.49|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-51.33|-37.65|||ANCOVA|||||-37.65|-51.33|<0.001
91550709|NCT03899259|182984228|SUPERIORITY||Odds Ratio (OR)|4.63||||0.005|TWO_SIDED|95.0|1.58|13.6|||Regression, Logistic|||||13.60|1.58|0.005
91766597|NCT01276639|183422174|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-4.75|-3.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.05|-4.75|<0.0001
91550710|NCT03899259|182984228|SUPERIORITY||Odds Ratio (OR)|12.94|||<|0.001|TWO_SIDED|95.0|4.72|35.44|||Regression, Logistic|||||35.44|4.72|<0.001
91550711|NCT03899259|182984229|SUPERIORITY||Odds Ratio (OR)|4.36||||0.001|TWO_SIDED|95.0|1.77|10.74|||Regression, Logistic|||||10.74|1.77|0.001
91550712|NCT03899259|182984229|SUPERIORITY||Odds Ratio (OR)|13.37|||<|0.001|TWO_SIDED|95.0|5.75|31.1|||Regression, Logistic|||||31.10|5.75|<0.001
91550713|NCT03899259|182984231|SUPERIORITY||Odds Ratio (OR)|2.56||||0.076|TWO_SIDED|95.0|0.91|7.24|||Regression, Logistic|||||7.24|0.91|0.076
91550714|NCT03899259|182984231|SUPERIORITY||Odds Ratio (OR)|10.3|||<|0.001|TWO_SIDED|95.0|4.12|25.77|||Regression, Logistic|||||25.77|4.12|<0.001
91550715|NCT03899259|182984232|SUPERIORITY||Odds Ratio (OR)|1.88||||0.26|TWO_SIDED|95.0|0.63|5.62|||Regression, Logistic|||||5.62|0.63|0.260
91550716|NCT03899259|182984232|SUPERIORITY||Odds Ratio (OR)|8.1|||<|0.001|TWO_SIDED|95.0|3.18|20.66|||Regression, Logistic|||||20.66|3.18|<0.001
91550717|NCT03899259|182984233|SUPERIORITY||Odds Ratio (OR)|3.43||||0.017|TWO_SIDED|95.0|1.25|9.4|||Regression, Logistic|||||9.40|1.25|0.017
91550718|NCT03899259|182984233|SUPERIORITY||Odds Ratio (OR)|10.85|||<|0.001|TWO_SIDED|95.0|4.32|27.25|||Regression, Logistic|||||27.25|4.32|<0.001
91550719|NCT03899259|182984234|SUPERIORITY||Odds Ratio (OR)|14.63||||0.002|TWO_SIDED|95.0|2.73|78.42|||Regression, Logistic|||||78.42|2.73|0.002
91550720|NCT03899259|182984234|SUPERIORITY||Odds Ratio (OR)|30.37|||<|0.001|TWO_SIDED|95.0|5.93|99.99|||Regression, Logistic|||||99.99|5.93|<0.001
91550721|NCT03899259|182984235|SUPERIORITY||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|1.981||0.129|TWO_SIDED|95.0|-6.91|0.88|||ANCOVA|||||0.88|-6.91|0.129
91550722|NCT03899259|182984235|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|1.799||0.02|TWO_SIDED|95.0|-7.75|-0.68|||ANCOVA|||||-0.68|-7.75|0.020
91550723|NCT03899259|182984236|SUPERIORITY||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.017||0.026|TWO_SIDED|95.0|-12.68|-0.82|||ANCOVA|||||-0.82|-12.68|0.026
91550724|NCT03899259|182984236|SUPERIORITY||Mean Difference (Final Values)|-13.42|STANDARD_ERROR_OF_MEAN|2.737|<|0.001|TWO_SIDED|95.0|-18.8|-8.04|||ANCOVA|||||-8.04|-18.80|<0.001
91550725|NCT03899259|182984237|SUPERIORITY||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.68||0.103|TWO_SIDED|95.0|-9.65|0.88|||ANCOVA|||||0.88|-9.65|0.103
91550726|NCT03899259|182984237|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|2.429|<|0.001|TWO_SIDED|95.0|-13.1|-3.56|||ANCOVA|||||-3.56|-13.10|<0.001
91550727|NCT03899259|182984238|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.315||0.518|TWO_SIDED|95.0|-0.82|0.42|||ANCOVA|||||0.42|-0.82|0.518
91550728|NCT03899259|182984238|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.286||0.012|TWO_SIDED|95.0|-1.28|-0.16|||ANCOVA|||||-0.16|-1.28|0.012
91550729|NCT03899259|182984239|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.291||0.083|TWO_SIDED|95.0|-1.08|0.07|||ANCOVA|||||0.07|-1.08|0.083
91550730|NCT03899259|182984239|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.264||0.01|TWO_SIDED|95.0|-1.2|-0.16|||ANCOVA|||||-0.16|-1.20|0.010
91550731|NCT01152450|182984240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.102|0.196|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.196|0.102|<0.0001
91550732|NCT01152450|182984240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.111|0.205|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.205|0.111|<0.0001
91550733|NCT01152450|182984240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.038|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.056|-0.038|
91550734|NCT01152450|182984241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.328|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001||95.0|11.084|31.573|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||31.573|11.084|<0.0001
91550735|NCT01152450|182984241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|5.225|<|0.0001||95.0|12.044|32.67|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||32.670|12.044|<0.0001
91550736|NCT01152450|182984241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|5.242||||95.0|-9.318|11.376|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||11.376|-9.318|
91550737|NCT01152450|182984242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.92|STANDARD_ERROR_OF_MEAN|5.026|<|0.0001||95.0|20.001|39.839|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||39.839|20.001|<0.0001
91550738|NCT01152450|182984242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.657|STANDARD_ERROR_OF_MEAN|5.042|<|0.0001||95.0|18.707|38.606|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||38.606|18.707|<0.0001
91550739|NCT01152450|182984242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.264|STANDARD_ERROR_OF_MEAN|5.056||||95.0|-11.243|8.716|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||8.716|-11.243|
91550740|NCT01152450|182984243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.218|0.120|<0.0001
91550741|NCT01152450|182984243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.136|0.234|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.234|0.136|<0.0001
91550742|NCT01152450|182984243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.025||||95.0|-0.033|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.065|-0.033|
91550743|NCT01152450|182984244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.181|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.181|0.077|<0.0001
91550744|NCT01152450|182984244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.079|0.183|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.183|0.079|<0.0001
91550745|NCT01152450|182984244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.05|0.054|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.054|-0.050|
91550746|NCT01152450|182984245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.179|0.084|<0.0001
91550747|NCT01152450|182984245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.179|0.084|<0.0001
91550748|NCT01152450|182984245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.048|0.047|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.047|-0.048|
91550749|NCT01152450|182984246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.17|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.170|0.053|0.0002
91550750|NCT01152450|182984246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.074|0.191|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.191|0.074|<0.0001
91550751|NCT01152450|182984246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.03||||95.0|-0.037|0.08|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.080|-0.037|
91550752|NCT01152450|182984247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.035||0.0515||95.0|0.0|0.136|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.136|0.000|0.0515
91550753|NCT01152450|182984247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.035||0.1058||95.0|-0.012|0.124|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.124|-0.012|0.1058
91550754|NCT01152450|182984247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.08|0.057|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.057|-0.080|
91550755|NCT01152450|182984248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.177|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.177|0.073|<0.0001
91550756|NCT01152450|182984248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.026||0.0002||95.0|0.048|0.152|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.152|0.048|0.0002
91550757|NCT01152450|182984248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.077|0.027|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.027|-0.077|
91550758|NCT01152450|182984249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.027||0.0051||95.0|0.023|0.129|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.129|0.023|0.0051
91550759|NCT01152450|182984249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.027||0.0123||95.0|0.015|0.12|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.120|0.015|0.0123
91550760|NCT01152450|182984249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.061|0.045|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.045|-0.061|
91550761|NCT01152450|182984250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.027||0.0042||95.0|0.025|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.130|0.025|0.0042
91550762|NCT01152450|182984250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.0747||95.0|-0.005|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.005|0.0747
91550763|NCT01152450|182984250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.082|0.023|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.023|-0.082|
91550764|NCT01152450|182984254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.055|0.147|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.147|0.055|<0.0001
91550765|NCT01152450|182984254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.023||0.0004||95.0|0.038|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.130|0.038|0.0004
91550766|NCT01152450|182984254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.063|0.03|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.030|-0.063|
91550767|NCT01152450|182984255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.242|STANDARD_ERROR_OF_MEAN|4.091|<|0.0001||95.0|22.167|38.317|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||38.317|22.167|<0.0001
91550768|NCT01152450|182984255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.31|STANDARD_ERROR_OF_MEAN|4.089|<|0.0001||95.0|26.24|42.38|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||42.380|26.240|<0.0001
91550769|NCT01152450|182984255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.068|STANDARD_ERROR_OF_MEAN|4.094||||95.0|-4.012|12.148|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||12.148|-4.012|
91550770|NCT01152450|182984256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.769||0.6747||95.0|-1.195|1.841|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||1.841|-1.195|0.6747
91550771|NCT01152450|182984256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.389|STANDARD_ERROR_OF_MEAN|0.774||0.6159||95.0|-1.138|1.916|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||1.916|-1.138|0.6159
91550772|NCT01152450|182984256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.777||||95.0|-1.468|1.599|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||1.599|-1.468|
91766598|NCT01276639|183422174|SUPERIORITY_OR_OTHER||LS mean difference|-4.71|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-5.56|-3.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.86|-5.56|<0.0001
91550773|NCT01152450|182984257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.142||0.5906||95.0|-0.358|0.204|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.204|-0.358|0.5906
91550774|NCT01152450|182984257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.143||0.2208||95.0|-0.458|0.106|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.106|-0.458|0.2208
91550775|NCT01152450|182984257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.143||||95.0|-0.382|0.184|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.184|-0.382|
91550776|NCT01152450|182984258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.082||0.9797||95.0|-0.163|0.159|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.159|-0.163|0.9797
91550777|NCT01152450|182984258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.082||0.4518||95.0|-0.223|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.223|0.4518
91550778|NCT01152450|182984258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.082||||95.0|-0.222|0.102|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.102|-0.222|
91550779|NCT01152450|182984259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.074||0.4089||95.0|-0.207|0.085|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.085|-0.207|0.4089
91550780|NCT01152450|182984259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.074||0.3185||95.0|-0.221|0.072|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.072|-0.221|0.3185
91550781|NCT01152450|182984259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.074||||95.0|-0.16|0.134|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.134|-0.160|
91550782|NCT01152450|182984260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031||0.9626||95.0|-0.059|0.062|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.062|-0.059|0.9626
91550783|NCT01152450|182984260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.031||0.9102||95.0|-0.058|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.065|-0.058|0.9102
91550784|NCT01152450|182984260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.031||||95.0|-0.059|0.063|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.063|-0.059|
91550785|NCT03738852|182984261|SUPERIORITY|||||||0.907|||||||ANOVA|||||||0.907
91550786|NCT04508309|182984278|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.09|||||TWO_SIDED|98.3|0.891|1.327|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.327|0.891|
91550787|NCT04508309|182984278|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.78|||||TWO_SIDED|98.3|1.455|2.176|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% CI was used.||2.176|1.455|
91550788|NCT04508309|182984278|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|2.37|||||TWO_SIDED|98.3|1.942|2.903|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.903|1.942|
91550789|NCT04508309|182984279|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.25|||||TWO_SIDED|98.3|1.022|1.539|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.539|1.022|
91550790|NCT04508309|182984279|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.68|||||TWO_SIDED|98.3|1.372|2.069|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.069|1.372|
91550791|NCT04508309|182984279|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.71|||||TWO_SIDED|98.3|1.389|2.102|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.102|1.389|
91550792|NCT04508309|182984284|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.75|||||TWO_SIDED|95.0|1.476|2.071|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||2.071|1.476|
91550793|NCT04508309|182984285|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.21|||||TWO_SIDED|95.0|1.004|1.451|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.451|1.004|
91550794|NCT04508309|182984286|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.933|1.344|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.344|0.933|
91766599|NCT01276639|183422174|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.35||0.0212|TWO_SIDED|95.0|-1.5|-0.12|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.12|-1.50|0.0212
91550795|NCT04508309|182984287|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.32|||||TWO_SIDED|95.0|1.07|1.635|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.635|1.070|
91550796|NCT06182033|182984319|OTHER|||||||0.84|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.84
91550797|NCT06182033|182984320|OTHER|||||||0.727|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.727
91550798|NCT06182033|182984321|OTHER|||||||0.205|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the assertiveness subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.205
91550799|NCT06182033|182984321|OTHER|||||||0.034|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||This analysis focused specifically on the behavior control subscale. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.034
91550800|NCT06182033|182984321|OTHER|||||||0.099|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the Task Orientation subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.099
91550801|NCT06182033|182984321|OTHER|||||||0.209|||||||Regression, Linear|||This analysis used peer social skills subscale as the outcome in the model. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.209
91550802|NCT06182033|182984322|OTHER|||||||0.82|||||||Multilevel Model|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.82
91550803|NCT06182033|182984323|OTHER|||||||0.67|||||||Multilevel Model|Kenward-Rogers and Restricted Maximum Likelihood adjustments in light of small sample size to reduce error likelihood.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.67
91550804|NCT06182033|182984324|OTHER|||||||0.024|||||||Regression, Linear|Kenward-Rogers and Restricted Maximum Likelihood to account for the small sample size.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.024
91550805|NCT06182033|182984325|OTHER|||||||0.013|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.013
91550806|NCT02151981|182984352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED|95.0|0.23|0.41|||Log Rank||A hazard ratio \<1 favours Osimertinib 80mg|||0.41|0.23|<0.001
91550807|NCT02151981|182984353|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.39|||<|0.001|TWO_SIDED|95.0|3.47|8.48|||Regression, Logistic|adjusted for ethnicity (Asian/non-Asian)|odds ratio \>1.0 favours Osimertinib 80 mg|||8.48|3.47|<0.001
91550808|NCT02151981|182984354|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Expected (DoR)|6.22|||<|0.001|TWO_SIDED|95.0|4.04|9.57|||formulae provided in Ellis S et al 2008|Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients||||9.57|4.04|<0.001
91550809|NCT02151981|182984355|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.76|||<|0.001|TWO_SIDED|95.0|2.64|8.84|||Regression, Logistic||odds ratio \>1.0 favours Osimertinib 80 mg|||8.84|2.64|<0.001
91550810|NCT02151981|182984356|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-21.62|||<|0.001|TWO_SIDED|95.0|-27.71|-15.52|||ANCOVA|Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions|LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg|||-15.52|-27.71|<0.001
91550811|NCT02151981|182984357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.277|TWO_SIDED|95.0|0.67|1.13|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.13|0.67|0.277
91550812|NCT02151981|182984358|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.16|0.28|||Log Rank||A hazard ratio \<1 favors Osimertinib 80mg|||0.28|0.16|<0.001
91550813|NCT02151981|182984359|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||<|0.001|TWO_SIDED|95.0|0.69|1.11|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.11|0.69|<0.001
91550814|NCT01922050|182984372|SUPERIORITY||Rate ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.69|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.69|0.40|<0.001
91550815|NCT01922050|182984372|SUPERIORITY||Rate ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.35|0.61|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.61|0.35|<0.001
91550816|NCT01922050|182984372|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.48|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.48|0.28|<0.001
91550817|NCT01922050|182984372|SUPERIORITY||Rate ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.17|0.66|0.38
91550818|NCT01922050|182984372|SUPERIORITY||Rate ratio|0.69||||0.013|TWO_SIDED|95.0|0.52|0.93|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.93|0.52|0.013
91550819|NCT01922050|182984372|SUPERIORITY||Rate ratio|0.79||||0.13|TWO_SIDED|95.0|0.58|1.07|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.07|0.58|0.13
91550820|NCT01922050|182984373|SUPERIORITY||Ratio of clearance rates|0.74||||0.57|TWO_SIDED|95.0|0.27|2.04|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.04|0.27|0.57
91550821|NCT01922050|182984373|SUPERIORITY||Ratio of clearance rates|1.33||||0.51|TWO_SIDED|95.0|0.56|3.13|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||3.13|0.56|0.51
91550822|NCT01922050|182984373|SUPERIORITY||Ratio of clearance rates|1.9||||0.11|TWO_SIDED|95.0|0.86|4.21|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.21|0.86|0.11
91550823|NCT01922050|182984373|SUPERIORITY||Ratio of clearance rates|1.79||||0.21|TWO_SIDED|95.0|0.72|4.43|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.43|0.72|0.21
91550824|NCT01922050|182984373|SUPERIORITY||Ratio of clearance rates|2.55||||0.031|TWO_SIDED|95.0|1.09|5.98|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||5.98|1.09|0.031
91766600|NCT01276639|183422174|SUPERIORITY_OR_OTHER||LS mean difference|-4.98|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-6.02|-3.95||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.95|-6.02|<0.0001
91766601|NCT01276639|183422174|SUPERIORITY_OR_OTHER||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-8.0|-5.94||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.94|-8.00|<0.0001
91550825|NCT01922050|182984373|SUPERIORITY||Ratio of clearance rates|1.43||||0.29|TWO_SIDED|95.0|0.74|2.75|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.75|0.74|0.29
91550826|NCT01922050|182984374|SUPERIORITY||Ratio of clearance rates|1.69||||0.026|TWO_SIDED|95.0|1.06|2.69|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.69|1.06|0.026
91550827|NCT01922050|182984374|SUPERIORITY||Ratio of clearance rates|1.79||||0.013|TWO_SIDED|95.0|1.13|2.84|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.84|1.13|0.013
91550828|NCT01922050|182984374|SUPERIORITY||Ratio of clearance rates|2.1|||<|0.001|TWO_SIDED|95.0|1.35|3.25|||Log binomial regression|||||3.25|1.35|<0.001
91550829|NCT01922050|182984374|SUPERIORITY||Ratio of clearance rates|1.06||||0.73|TWO_SIDED|95.0|0.76|1.47|||Log binomial regression|||||1.47|0.76|0.73
91550830|NCT01922050|182984374|SUPERIORITY||Ratio of clearance rates|1.24||||0.16|TWO_SIDED|95.0|0.92|1.67|||Log binomial regression|||||1.67|0.92|0.16
91550831|NCT01922050|182984374|SUPERIORITY||Ratio of clearance rates|1.17||||0.3|TWO_SIDED|95.0|0.87|1.57|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||1.57|0.87|0.30
91550832|NCT04642820|182984430|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
91550833|NCT04568434|182984431|SUPERIORITY||LS mean difference|-43.5|||=|0.0009|TWO_SIDED|95.0|-69.085|-17.921||ANCOVA model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-17.921|-69.085|=0.0009
91550834|NCT04568434|182984431|SUPERIORITY||Least squares (LS) mean difference|-22.37|||=|0.0775|TWO_SIDED|95.0|-47.2|2.463||Analysis of covariance (ANCOVA) model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||2.463|-47.200|=0.0775
91550835|NCT04568434|182984432|SUPERIORITY||LS mean difference|-43.81|||=|0.0044|TWO_SIDED|95.0|-73.928|-13.692||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-13.692|-73.928|=0.0044
91550836|NCT04568434|182984432|SUPERIORITY||LS mean difference|-59.39|||=|0.0002|TWO_SIDED|95.0|-90.663|-28.119||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-28.119|-90.663|=0.0002
91550837|NCT04568434|182984433|SUPERIORITY||LS mean difference|-65.48|||<|0.0001|TWO_SIDED|95.0|-82.634|-48.32||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-48.320|-82.634|<0.0001
91550838|NCT04568434|182984433|SUPERIORITY||LS mean difference|-73.69|||<|0.0001|TWO_SIDED|95.0|-94.553|-52.837||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-52.837|-94.553|<0.0001
91550839|NCT04568434|182984433|SUPERIORITY||Ls mean difference|-77.06|||<|0.0001|TWO_SIDED|95.0|-98.938|-55.177||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-55.177|-98.938|<0.0001
91550840|NCT04568434|182984433|SUPERIORITY||LS mean difference|-81.28|||<|0.0001|TWO_SIDED|95.0|-104.656|-57.894||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-57.894|-104.656|<0.0001
91550841|NCT04568434|182984435|SUPERIORITY||LS mean difference|-33.29|||=|0.186|TWO_SIDED|95.0|-82.612|16.041||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||16.041|-82.612|=0.1860
91550842|NCT04568434|182984435|SUPERIORITY||LS mean difference|-83.97|||=|0.0019|TWO_SIDED|95.0|-136.949|-30.982||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||-30.982|-136.949|=0.0019
91550843|NCT04568434|182984435|SUPERIORITY||LS mean difference|-32.9|||=|0.4219|TWO_SIDED|95.0|-113.254|47.459||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||47.459|-113.254|=0.4219
91766602|NCT01276639|183422174|SUPERIORITY_OR_OTHER||LS mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.8|-1.17|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.17|-2.80|<0.0001
91766603|NCT01276639|183422175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.34|||<|0.0001|TWO_SIDED|95.0|3.23|35.12||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.12|3.23|<0.0001
91766604|NCT01276639|183422175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53|||<|0.0001|TWO_SIDED|95.0|5.06|54.42||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||54.42|5.06|<0.0001
91766605|NCT01276639|183422175|SUPERIORITY_OR_OTHER||Percent difference|5.98|STANDARD_ERROR_OF_MEAN|2.97||0.0443|TWO_SIDED|95.0|0.15|11.8|||Normal approximation|||||11.80|0.15|0.0443
91766606|NCT01276639|183422176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.76||||0.0003|TWO_SIDED|95.0|2.11|35.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.77|2.11|0.0003
91766607|NCT01276639|183422176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.64|59.98||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||59.98|3.64|<0.0001
91766608|NCT01276639|183422176|SUPERIORITY_OR_OTHER||Percent difference|5.09|STANDARD_ERROR_OF_MEAN|2.5||0.0415|TWO_SIDED|95.0|0.19|9.98|||Normal approximation|||||9.98|0.19|0.0415
91550844|NCT04568434|182984435|SUPERIORITY||LS mean difference|-75.63|||=|0.056|TWO_SIDED|95.0|-153.195|1.927||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||1.927|-153.195|=0.0560
91550845|NCT04568434|182984436|SUPERIORITY||LS mean difference|-17.69|||=|0.0401|TWO_SIDED|95.0|-34.571|-0.801||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline Month 6||-0.801|-34.571|=0.0401
91550846|NCT04568434|182984436|SUPERIORITY||LS mean difference|-24.2|||=|0.0036|TWO_SIDED|95.0|-40.484|-7.911||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate|ANCOVA|||Percent Change from Baseline Month 6||-7.911|-40.484|=0.0036
91550847|NCT04568434|182984436|SUPERIORITY||LS mean difference|-29.84|||=|0.0134|TWO_SIDED|95.0|-53.49|-6.198||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-6.198|-53.490|=0.0134
91550848|NCT04568434|182984436|SUPERIORITY||LS mean difference|-39.7|||=|0.0009|TWO_SIDED|95.0|-63.108|-16.292||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-16.292|-63.108|=0.0009
91550849|NCT04568434|182984437|SUPERIORITY||Mean Rate Ratio|0.1|||=|0.0052|TWO_SIDED|95.0|0.02|0.506||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.506|0.020|=0.0052
91550850|NCT04568434|182984438|SUPERIORITY||Mean Rate Ratio|0.12|||=|0.0144|TWO_SIDED|95.0|0.022|0.656||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.656|0.022|=0.0144
91766609|NCT01276639|183422177|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|17.6|<|0.0001|TWO_SIDED|95.0|-104.27|-35.13||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-35.13|-104.27|<0.0001
91550851|NCT04568434|182984439|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0174|TWO_SIDED|95.0|0.028|0.709||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.709|0.028|=0.0174
91550852|NCT04568434|182984440|SUPERIORITY||Mean Rate Ratio|0.16|||=|0.0314|TWO_SIDED|95.0|0.031|0.85||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.850|0.031|=0.0314
91766610|NCT01276639|183422177|SUPERIORITY_OR_OTHER||LS mean difference|-97.03|STANDARD_ERROR_OF_MEAN|17.47|<|0.0001|TWO_SIDED|95.0|-131.35|-62.72||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-62.72|-131.35|<0.0001
91766611|NCT01276639|183422177|SUPERIORITY_OR_OTHER||LS mean difference|-27.33|STANDARD_ERROR_OF_MEAN|13.22||0.0391|TWO_SIDED|95.0|-53.29|-1.37|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.37|-53.29|0.0391
91766612|NCT01276639|183422181|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766613|NCT01276639|183422181|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766614|NCT01276639|183422181|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766615|NCT01276639|183422182|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766616|NCT01276639|183422182|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766617|NCT01276639|183422182|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766618|NCT01276639|183422183|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766619|NCT01276639|183422183|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91550853|NCT04568434|182984443|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0137|TWO_SIDED|95.0|0.029|0.669||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable|Negative Binomial Regression Model|||||0.669|0.029|=0.0137
91550854|NCT04568434|182984444|SUPERIORITY||Mean Rate Ratio|0.2|||=|0.048|TWO_SIDED|95.0|0.04|0.986||Regression model:treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.986|0.040|=0.0480
91550855|NCT05693935|182984497|OTHER||LS Mean Difference|-9.75|||<|0.0001|TWO_SIDED|95.0|-13.6|-5.89||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||-5.89|-13.60|<0.0001
91550856|NCT05693935|182984497|OTHER||LS Mean Difference|-11.27|||<|0.0001|TWO_SIDED|95.0|-15.01|-7.53||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||-7.53|-15.01|<0.0001
91550857|NCT05693935|182984497|OTHER||LS Mean Difference|-9.76|||<|0.0001|TWO_SIDED|95.0|-13.5|-6.02||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||-6.02|-13.50|<0.0001
91550858|NCT05693935|182984498|OTHER||LS Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.31||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||-0.31|-0.75|<0.0001
91550859|NCT05693935|182984498|OTHER||LS Mean Difference|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.39||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||-0.39|-0.82|<0.0001
91550860|NCT05693935|182984498|OTHER||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.25||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||-0.25|-0.68|<0.0001
91550861|NCT05693935|182984499|OTHER||LS Mean Difference|4.72||||0.0011|TWO_SIDED|95.0|2.05|7.4||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||7.40|2.05|0.0011
91550862|NCT05693935|182984499|OTHER||LS Mean Difference|3.24||||0.0167|TWO_SIDED|95.0|0.59|5.89||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||5.89|0.59|0.0167
91550863|NCT05693935|182984499|OTHER||LS Mean Difference|5.01||||0.0007|TWO_SIDED|95.0|2.35|7.66||p-value was adjusted for multiple comparisons (using Truncated Hochberg).|Mixed Models Analysis|||Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules.||7.66|2.35|0.0007
91550864|NCT00085735|182984575|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.5|||||ONE_SIDED|80.0||1.9||||||The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.||1.9||
91550865|NCT00085735|182984575|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.0|||||ONE_SIDED|94.0||1.3||||||The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.||1.3||
91550866|NCT01824875|182984595|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.07|||||Hazard ratio of Arm B/Arm A|||1.07|0.46|
91550867|NCT01824875|182984596|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
91766620|NCT01276639|183422183|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
91766621|NCT03170661|183422248|SUPERIORITY|||||||0.94|||||||GEEGLM|Effects of GEEGLM covariates: surgeon, p = 0.24; surgery length, p= 0.73 and body mass index, p= 0.22).||||||0.94
91766622|NCT01217463|183422295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.4109|TWO_SIDED|95.0|0.6|3.43|||Regression, Logistic|||||3.43|0.60|0.4109
91550868|NCT05256017|182984622|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||||3.7|-7.2|
91550869|NCT05256017|182984623|OTHER||Excess rate (ER)|-0.9|||||TWO_SIDED|95.0|-4.1|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|Occurrence and excess rate (95% CI) of any TEAEs (by PT, for PTs reported in ≥1% of participants in either arm) from the investigational product administration (Day 1) to the Month 4 follow-up visit.||1.4|-4.1|
91550870|NCT05256017|182984624|OTHER||Excess rate (ER)|0.4|||||TWO_SIDED|95.0|-1.6|1.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.6|-1.6|
91550871|NCT05256017|182984625|OTHER||Excess rate (ER)|-0.5|||||TWO_SIDED|95.0|-3.2|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.4|-3.2|
91550872|NCT05256017|182984626|OTHER||Excess rate (ER)|-0.6|||||TWO_SIDED|95.0|-2.6|0.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.6|-2.6|
91766623|NCT01217463|183422296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|0.78|2.4|||Regression, Logistic|||||2.4|0.78|
91766624|NCT03609177|183422303|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.05|TWO_SIDED|95.0|2.8|10.8|||binomial regression with identity link|||||10.8|2.8|<0.05
91766625|NCT03609177|183422304|SUPERIORITY||Risk Difference (RD)|-0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.6|||binomial regression with identity link|||||0.6|-0.7|<0.05
91766626|NCT03609177|183422305|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.05|TWO_SIDED|95.0|-0.5|1.9|||binomial regression with identity link|||||1.90|-0.5|<0.05
91766627|NCT03609177|183422306|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.05|TWO_SIDED|95.0|-0.4|1.0|||binomial regression with identity link|||||1.0|-0.4|<0.05
91766628|NCT01126723|183422314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The a priori threshold for statistical significance was set to 0.05.|Fisher Exact|||||||0.15
91766629|NCT00279916|183422335|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
91766630|NCT00279916|183422336|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
91766631|NCT04532034|183422343|OTHER||Mean Difference (Final Values)|0.067||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||.95
91550873|NCT05256017|182984627|OTHER||Excess rate (ER)|-0.2|||||TWO_SIDED|95.0|-2.2|0.8|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.8|-2.2|
91550874|NCT05256017|182984628|OTHER||Excess rate (ER)|-0.3|||||TWO_SIDED|95.0|-2.3|0.7|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.7|-2.3|
91550875|NCT05256017|182984629|OTHER||Excess rate (ER)|3.2|||||TWO_SIDED|95.0|0.3|5.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||5.3|0.3|
91550876|NCT05256017|182984630|OTHER||Excess rate (ER)|-0.1|||||TWO_SIDED|95.0|-2.4|1.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.3|-2.4|
91766632|NCT01598922|183422346|OTHER|Intent-to-treat (ITT) analyses following multiple imputation. Generalized Linear Models (GENLIN) predicting post-treatment HRSD scores in the imputed dataset. Covarying for pre-treatment HRSD scores, age and sex.|Odds Ratio (OR)|6.11|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|2.814|9.403|||GENLIN|||||9.403|2.814|<0.0001
91766633|NCT01598922|183422347|OTHER||Cohen's d measure of effect size|-0.79||||0.024|TWO_SIDED|95.0|-1.25|-0.32||Hierarchical Linear Modeling (HLM) was applied to PHQ-9 data, adjusting for baseline PHQ-9 score. Group x Time interactions tested for between-group differences in slope of improvement of PHQ-9 scores.|hierarchical linear modeling|Age and sex were covariates. Cohen's d effect sizes are reported.||||-0.32|-1.25|.024
91766634|NCT01598922|183422348|OTHER|Hierarchical Linear Modeling (HLM) was applied to K-10 data, adjusting for baseline K-10 score. Group x Time interactions tested for between-group differences in slope of improvement of K-10 scores.|Cohen's d measure of effect size|-0.95||||0.003|TWO_SIDED|95.0|-1.42|-0.48|||HLM|||The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.||-0.48|-1.42|.003
91766635|NCT04184297|183422517|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.76|0.96|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||0.96|0.76|
91766636|NCT04184297|183422518|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|This method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of a hospitalization for community-acquired pneumonia for overall population.||1.07|0.64|
91550877|NCT05256017|182984631|OTHER||Excess rate (ER)|-1.1|||||TWO_SIDED|95.0|-3.5|0.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.3|-3.5|
91550878|NCT05256017|182984632|OTHER||Excess rate (ER)|1.0|||||TWO_SIDED|95.0|-3.7|5.1||||||Occurrence and excess rate (95% CI) of any TEAEs reported during hospitalization.||5.1|-3.7|
91550879|NCT05256017|182984632|OTHER||Excess rate (ER)|-3.3|||||TWO_SIDED|95.0|-8.2|0.9||||||Occurrence and excess rate (95% CI) of any TEAEs reported after the hospitalization period.||0.9|-8.2|
91550880|NCT05256017|182984633|OTHER||Excess rate (ER)|-1.0|||||TWO_SIDED|95.0|-3.1|0.0||||||||0.0|-3.1|
91766637|NCT04184297|183422519|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||1.19|0.91|
91766638|NCT03775486|183422574|OTHER||Hazard Ratio (HR)|0.76||||0.074|TWO_SIDED|95.0|0.57|1.02|||Log Rank|||||1.02|0.57|0.074
91766639|NCT03775486|183422574|OTHER||Median|7.2|||||TWO_SIDED|95.0|5.3|7.9||||||Median progression-free survival (months)||7.9|5.3|
91766640|NCT03775486|183422574|OTHER||Median|5.3|||||TWO_SIDED|95.0|3.7|5.8||||||Median progression-free survival (months)||5.8|3.7|
91550881|NCT05256017|182984634|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||Of note, all AEs reported during this study were TEAEs.||3.7|-7.2|
91550882|NCT05256017|182984652|OTHER||Placebo-corrected change from baseline|-0.4|||||TWO_SIDED|90.0|-2.1|1.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.4|-2.1|
91550883|NCT05256017|182984653|OTHER||Placebo-corrected change from baseline|-0.5|||||TWO_SIDED|90.0|-22.0|21.1||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||21.1|-22.0|
91550884|NCT05256017|182984654|OTHER||Placebo-corrected change from baseline|-1.1|||||TWO_SIDED|90.0|-3.6|1.3||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.3|-3.6|
91550885|NCT05256017|182984655|OTHER||Placebo-corrected change from baseline|-0.7|||||TWO_SIDED|90.0|-1.9|0.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||0.4|-1.9|
91766641|NCT03775486|183422575|OTHER||Hazard Ratio (HR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36|||Log Rank|||||1.36|0.59|0.604
91766642|NCT03775486|183422575|OTHER||Median|17.4|||||TWO_SIDED|95.0|14.1||NA = insufficient number of participants with events|||||Median overall survival (months)|||14.1|
91766643|NCT03775486|183422575|OTHER||Median overall survival (months)|11.8|||||TWO_SIDED|95.0|11.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value|Median overall survival (months)|||11.8|
91766644|NCT03775486|183422577|OTHER|Median duration of response (months)|Median duration of response|6.5|||||TWO_SIDED|95.0|6.5||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||6.5|
91766645|NCT03775486|183422577|OTHER|Median duration of response (months)|Median duration of response|3.8|||||TWO_SIDED|95.0|3.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||3.8|
91766646|NCT03775486|183422578|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.07|2.0||||||||2.00|0.07|
91766647|NCT03775486|183422578|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.7||NA = insufficient number of participants with events|||||Median progression-free survival (months)|||1.7|
91766648|NCT03775486|183422578|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.2|16.6||||||Median progression-free survival (months)||16.6|1.2|
91550886|NCT05256017|182984656|OTHER||Placebo-corrected change from baseline|-10.9|||||TWO_SIDED|90.0|-15.3|-6.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-6.6|-15.3|
91550887|NCT05256017|182984657|OTHER||Placebo-corrected change from baseline|-11.5|||||TWO_SIDED|90.0|-14.4|-8.7||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.7|-14.4|
91550888|NCT05256017|182984658|OTHER||Placebo-corrected change from baseline|-11.7|||||TWO_SIDED|90.0|-14.9|-8.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.6|-14.9|
91766649|NCT03775486|183422580|OTHER||Estimated difference in adjusted mean|-0.51|||||TWO_SIDED|95.0|-4.47|3.46||||||EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.||3.46|-4.47|
91766650|NCT03775486|183422580|OTHER||Estimated difference in adjusted mean|0.95|||||TWO_SIDED|95.0|-4.81|6.71||||||EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.||6.71|-4.81|
91766651|NCT03775486|183422580|OTHER||Estimated difference in adjusted mean|-2.26|||||TWO_SIDED|95.0|-6.39|1.88||||||EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.||1.88|-6.39|
91766652|NCT03775486|183422582|OTHER||Estimated difference in adjusted mean|1.64|||||TWO_SIDED|95.0|-2.2|5.47||||||EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.||5.47|-2.20|
91766653|NCT03775486|183422582|OTHER||Estimated difference in adjusted mean|3.22|||||TWO_SIDED|95.0|-1.46|7.9||||||EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.||7.90|-1.46|
91766654|NCT05214768|183422600|SUPERIORITY||Least Square Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|74.98||0.003|TWO_SIDED|95.0|-370.2|-76.3|||ANCOVA|||||-76.3|-370.2|0.003
91766655|NCT03043872|183422633|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0047|TWO_SIDED|95.0|0.591|0.909||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \<1 favors D + EP to be associated with a longer OS than EP.||0.909|0.591|0.0047
91766656|NCT03043872|183422634|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0032|TWO_SIDED|95.0|0.625|0.91||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP.||0.910|0.625|0.0032
91766657|NCT03043872|183422634|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0451|TWO_SIDED|95.0|0.682|0.995||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|"D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.~HR \<1 favors D + T + EP to be associated with a longer OS than EP."||0.995|0.682|0.0451
91766658|NCT03043872|183422635|OTHER||Hazard Ratio (HR)|0.65||||0.0664|TWO_SIDED|95.0|0.414|1.029||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.029|0.414|0.0664
91766659|NCT03043872|183422636|OTHER||Hazard Ratio (HR)|0.75||||0.1455|TWO_SIDED|95.0|0.504|1.106||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.106|0.504|0.1455
91550889|NCT05256017|182984659|OTHER||Estimate|-10.7|STANDARD_DEVIATION|1.72|||TWO_SIDED|90.0|-13.5|-7.85||||||Estimated ΔΔQTcF (in ms) computed from a concentration-response (C-R) model between dry blood spot concentration of acoziborole and changes from baseline in QTcF parameter||-7.85|-13.5|
91550890|NCT06504862|182984701|OTHER||Ratio of adjusted geometric means [%]|133.98|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|105.52|170.11|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 39.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||170.11|105.52|
91766660|NCT03043872|183422636|OTHER||Hazard Ratio (HR)|0.65||||0.0314|TWO_SIDED|95.0|0.439|0.964||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||0.964|0.439|0.0314
91766661|NCT03043872|183422637|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4352|TWO_SIDED|95.0|0.89|1.309||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP.||1.309|0.890|0.4352
91766662|NCT03043872|183422638|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0157|TWO_SIDED|95.0|0.665|0.959||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP.||0.959|0.665|0.0157
91766663|NCT03043872|183422638|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0568|TWO_SIDED|95.0|0.696|1.005||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP.||1.005|0.696|0.0568
91766664|NCT03043872|183422638|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.235||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP.||1.235|0.857|0.7540
91766665|NCT03043872|183422639|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0177|TWO_SIDED|95.0|1.086|2.401||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP.||2.401|1.086|0.0177
91766666|NCT03043872|183422639|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3611|TWO_SIDED|95.0|0.817|1.746||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP.||1.746|0.817|0.3611
91766667|NCT03043872|183422651|OTHER||Hazard Ratio (HR)|0.86||||0.447|TWO_SIDED|95.0|0.574|1.277||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.277|0.574|0.4470
91550891|NCT06504862|182984702|OTHER||Ratio of adjusted geometric means [%]|124.19|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|96.13|160.43|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 42.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||160.43|96.13|
91550892|NCT06504862|182984703|OTHER||Ratio of adjusted geometric means [%]|230.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|195.68|271.04|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 26.7|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||271.04|195.68|
91550893|NCT06504862|182984704|OTHER||Ratio of adjusted geometric means [%]|301.68|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|90.0|247.19|368.19|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 33.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||368.19|247.19|
91550894|NCT06504862|182984705|OTHER||Ratio of adjusted geometric means [%]|83.02|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|76.48|90.12|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 13.3|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||90.12|76.48|
91766668|NCT03043872|183422652|OTHER||Hazard Ratio (HR)|0.97||||0.8934|TWO_SIDED|95.0|0.661|1.437||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.437|0.661|0.8934
91766669|NCT03043872|183422652|OTHER||Hazard Ratio (HR)|0.72||||0.1035|TWO_SIDED|95.0|0.487|1.068||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.068|0.487|0.1035
91766670|NCT03043872|183422652|OTHER||Hazard Ratio (HR)|0.76||||0.1673|TWO_SIDED|95.0|0.522|1.116||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.116|0.522|0.1673
91766671|NCT03043872|183422653|OTHER||Odds Ratio (OR)|1.39||||0.432|TWO_SIDED|95.0|0.61|3.244||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||3.244|0.610|0.4320
91766672|NCT03043872|183422653|OTHER||Odds Ratio (OR)|2.07||||0.0986|TWO_SIDED|95.0|0.874|5.118||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||5.118|0.874|0.0986
91766673|NCT02777827|183422683|SUPERIORITY||Least square mean|0.2221|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.1324|0.3118|||ANCOVA|||||0.3118|0.1324|<0.0001
91766674|NCT02777827|183422683|SUPERIORITY||Least Square Mean|0.4042|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.3146|0.4938|||ANCOVA|||||0.4938|0.3146|<0.0001
91766675|NCT02777827|183422683|SUPERIORITY||Least Square Mean|0.1056|STANDARD_ERROR_OF_MEAN|0.0451||0.0207|TWO_SIDED|95.0|0.0164|0.1949|||ANCOVA|||||0.1949|0.0164|0.0207
91766676|NCT02777827|183422683|SUPERIORITY||Least Square Mean|0.1701|STANDARD_ERROR_OF_MEAN|0.045||0.0002|TWO_SIDED|95.0|0.081|0.2592|||ANCOVA|||||0.2592|0.0810|0.0002
91766677|NCT02777827|183422683|SUPERIORITY||Least Square Mean|0.4062|STANDARD_ERROR_OF_MEAN|0.0451|<|0.0001|TWO_SIDED|95.0|0.317|0.4955|||ANCOVA|||||0.4955|0.3170|<0.0001
91766678|NCT04551066|183422707|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4224|TWO_SIDED|95.0|0.71|2.26||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||2.26|0.71|0.4224
91550895|NCT06504862|182984706|OTHER||Ratio of adjusted geometric means [%]|75.57|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|68.03|83.95|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 17.1|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||83.95|68.03|
91550896|NCT06504862|182984707|OTHER||Ratio of adjusted geometric means [%]|137.95|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|120.17|158.36|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 22.5|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||158.36|120.17|
91550897|NCT06504862|182984708|OTHER||Ratio of adjusted geometric means [%]|149.8|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|116.12|193.25|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 44.4|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||193.25|116.12|
91550898|NCT06504862|182984709|OTHER||Ratio of adjusted geometric means [%]|134.49|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|105.56|171.34|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 39.5|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||171.34|105.56|
91550899|NCT06504862|182984710|OTHER||Ratio of adjusted geometric means [%]|248.69|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|211.03|293.07|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 27.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||293.07|211.03|
91550900|NCT06504862|182984711|OTHER||Ratio of adjusted geometric means [%]|82.83|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|76.27|89.96|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 13.4|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||89.96|76.27|
91550901|NCT06504862|182984712|OTHER||Ratio of adjusted geometric means [%]|143.49|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|123.78|166.33|||||Ratio \[%\] = (adjusted geometric mean T/adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 24.2|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: participant (considered as random) and treatment (considered as fixed). These quantities were then back-transformed to the original scale.||166.33|123.78|
91766679|NCT04551066|183422708|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5728|TWO_SIDED|95.0|0.46|1.53||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||1.53|0.46|0.5728
91766680|NCT04551066|183422710|SUPERIORITY|||||||0.949||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.9490
91766681|NCT04551066|183422714|SUPERIORITY|||||||0.1085||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.1085
91766682|NCT04551066|183422715|SUPERIORITY|||||||0.6127||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.6127
91550902|NCT01574274|182984713|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91550903|NCT01574274|182984714|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Day 4 NSAA Level||||0.07
91550904|NCT01574274|182984714|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Day 11 NSAA Level||||0.29
91550905|NCT01574274|182984714|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Day 18 NSAA Level||||0.0002
91550906|NCT01574274|182984714|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Day 25 NSAA Level||||<0.0001
91550907|NCT01574274|182984714|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Week 7 NSAA Level||||<0.0001
91550908|NCT01574274|182984714|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Week 13 NSAA Level||||0.87
91550909|NCT01574274|182984714|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Week 19 NSAA Level||||0.83
91766683|NCT04491136|183422716|OTHER||||||>|0.9999|||||||McNemar|||At least one SVT occurred||||>0.9999
91766684|NCT04491136|183422716|OTHER|||||||0.7905|||||||McNemar|||At least one NSVT occurred||||0.7905
91766685|NCT04491136|183422716|OTHER|||||||0.625|||||||McNemar|||At least one PVC occurred||||0.6250
91766686|NCT04491136|183422718|OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.653||0.0008|TWO_SIDED|95.0|1.11|3.7|||Wilcoxon signed-rank|||||3.70|1.11|0.0008
91550910|NCT01574274|182984714|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Week 25 NSAA Level||||0.94
91550911|NCT03020199|182984778|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|5.9|48.3|||Regression, Logistic||Logistic regression model with treatment as an explanatory variable and subset of significant covariates (including Baseline PASI score, age, BMI and their interaction terms with treatment) selected using forward selection method.|Week 52 PASI 90||48.3|5.9|<0.0001
91550912|NCT03020199|182984779|SUPERIORITY||Odds Ratio (OR)|0.8||||0.653|TWO_SIDED|95.0|0.3|2.1|||Regression, Logistic||Exact logistic regression method for Treatment group comparison, without using any covariates.|Week 104 PASI 90||2.1|0.3|0.6530
91550913|NCT03852472|182984794|OTHER||% Difference (Avacopan - Placebo)|-8.4||||0.1321|TWO_SIDED|95.0|-18.7|2.4||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment).|Cochran-Mantel-Haenszel|||||2.4|-18.7|0.1321
91550914|NCT03852472|182984794|OTHER||% Difference (Avacopan - Placebo)|4.3||||0.4503|TWO_SIDED|95.0|-6.9|15.5||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment)|Cochran-Mantel-Haenszel|||||15.5|-6.9|0.4503
91550915|NCT03852472|182984795|OTHER||Least Squares Mean|0.6|STANDARD_ERROR_OF_MEAN|1.17||0.5784|TWO_SIDED|95.0|-1.7|2.9|||Mixed model for repeated measures|||||2.9|-1.7|0.5784
91550916|NCT03852472|182984795|OTHER||Least Squares Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.17||0.2253|TWO_SIDED|95.0|-3.7|0.9|||Mixed effects model for repeated measure|||||0.9|-3.7|0.2253
91550917|NCT05670587|182984826|OTHER||gMean ratio at Week 4|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric Coefficient of variation (gCV) = 84.59%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 4.||1.18|0.76|
91550918|NCT05670587|182984826|OTHER||gMean ratio at Week 8|0.84|||||TWO_SIDED|95.0|0.64|1.11|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 115.62%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 8.||1.11|0.64|
91550919|NCT05670587|182984826|OTHER||gMean ratio at Day 82|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 100.02%."|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Day 82.||1.29|0.75|
91550920|NCT01674140|182984839|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.77|1.14|||Log Rank|||||1.14|0.77|0.52
91550921|NCT01674140|182984840|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.75|1.26|||Log Rank|||||1.26|0.75|0.84
91550922|NCT01674140|182984842|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||||1.10|0.74|0.32
91550923|NCT05139810|182984847|SUPERIORITY||IC HAE attack rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.107|0.351|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used to account for potential over dispersion.||0.351|0.107|<0.001
91550924|NCT05139810|182984847|SUPERIORITY||IC HAE attack rate ratio|0.45|||=|0.004|TWO_SIDED|95.0|0.261|0.777|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential overdispersion.||0.777|0.261|=0.004
91550925|NCT05139810|182984848|SUPERIORITY||IC HAE attack rate ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.062|0.281|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.281|0.062|<0.001
91550926|NCT05139810|182984848|SUPERIORITY||IC HAE attack rate ratio|0.4|||=|0.004|TWO_SIDED|95.0|0.212|0.748|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.748|0.212|=0.004
91550927|NCT05139810|182984849|SUPERIORITY||Odds Ratio (OR)|11.79|||=|0.003|TWO_SIDED|95.0|2.34|59.36|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||59.36|2.34|=0.003
91550928|NCT05139810|182984849|SUPERIORITY||Odds Ratio (OR)|3.23|||=|0.24|TWO_SIDED|95.0|0.46|22.85|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||22.85|0.46|=0.240
91550929|NCT05139810|182984850|SUPERIORITY||IC HAE attack rate ratio|0.11|||<|0.001|TWO_SIDED|95.0|0.035|0.339|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.339|0.035|<0.001
91550930|NCT05139810|182984850|SUPERIORITY||IC HAE attack rate ratio|0.59|||=|0.173|TWO_SIDED|95.0|0.276|1.26|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||1.260|0.276|=0.173
91550931|NCT05139810|182984851|SUPERIORITY||Odds Ratio (OR)|310.35|||<|0.001|TWO_SIDED|95.0|11.63|8279.94|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||8279.94|11.63|<0.001
91550932|NCT05139810|182984851|SUPERIORITY||Odds Ratio (OR)|14.8|||<|0.001|TWO_SIDED|95.0|3.15|69.41|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||69.41|3.15|<0.001
91550933|NCT05139810|182984851|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|7.32|164.87|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||164.87|7.32|<0.001
91550934|NCT05139810|182984851|SUPERIORITY||Odds Ratio (OR)|9.17|||=|0.004|TWO_SIDED|95.0|2.05|41.09|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||41.09|2.05|=0.004
91550935|NCT05139810|182984851|SUPERIORITY||Odds Ratio (OR)|17.04|||<|0.001|TWO_SIDED|95.0|3.36|86.42|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||86.42|3.36|<0.001
91550936|NCT05139810|182984851|SUPERIORITY||Odds Ratio (OR)|8.7|||=|0.014|TWO_SIDED|95.0|1.56|48.52|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||48.52|1.56|=0.014
91550937|NCT05139810|182984852|SUPERIORITY||IC HAE attack rate ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.03|0.234|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.234|0.030|<0.001
91550938|NCT05139810|182984852|SUPERIORITY||IC HAE attack rate ratio|0.33|||=|0.004|TWO_SIDED|95.0|0.155|0.706|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.706|0.155|=0.004
91550939|NCT05139810|182984854|SUPERIORITY||Treatment difference|-18.56|||<|0.001|TWO_SIDED|95.0|-27.673|-9.454|||Mixed model with repeated measures(MMRM)|||||-9.454|-27.673|<0.001
91550940|NCT05139810|182984854|SUPERIORITY||Treatment difference|-13.65|||=|0.01|TWO_SIDED|95.0|-24.024|-3.286|||MMRM|||||-3.286|-24.024|=0.010
91550941|NCT03785964|182984875|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.55|||Log Rank|p-value was from a one-sided stratified log-rank test with placebo as reference.||Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.||0.55|0.15|< 0.001
91550942|NCT03785964|182984876|SUPERIORITY||||||<|0.001||||||Two-sided p-value|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.||||< 0.001
91550943|NCT03785964|182984877|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline Brief Pain Inventory Short Form score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 31 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
91550944|NCT03785964|182984878|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
91550945|NCT03785964|182984879|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 39 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
91766687|NCT04491136|183422719|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.028||0.5733|TWO_SIDED|95.0|-0.07|0.04|||Ridit analysis|||||0.04|-0.07|0.5733
91766688|NCT04491136|183422720|OTHER||Mean Difference (Final Values)|-231.46|STANDARD_ERROR_OF_MEAN|93.03||0.0006|TWO_SIDED|95.0|-415.9|-47.02|||Wilcoxon signed rank test|||||-47.02|-415.90|0.0006
91550946|NCT03785964|182984880|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||0.006
91550947|NCT03785964|182984881|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
91550948|NCT03785964|182984882|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
91550949|NCT03334630|182984883|NON_INFERIORITY|Assuming a Control composite SAE freedom rate of 93.5%, 226 subjects per group yields 80% power to detect a non-inferiority margin of -6.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.0324|||<|0.0001|TWO_SIDED|95.0|-0.0132|0.0779||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.0779|-0.0132|<0.0001
91550950|NCT03334630|182984884|NON_INFERIORITY|Assuming a Control primary effectiveness rate of 65%, 229 subjects per group yields 80% power to detect a non-inferiority margin of -12.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.034|||<|0.0001|TWO_SIDED|95.0|-0.042|0.109||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.4% = 0.034|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.109|-0.042|<0.0001
91550951|NCT03334630|182984885|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-21.2|-14.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-14.6|-21.2|<0.0001
91550952|NCT03334630|182984886|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-11.9|||<|0.0001|TWO_SIDED|95.0|-13.9|-9.8||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-9.8|-13.9|<0.0001
91550953|NCT03334630|182984895|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-14.4|3.1||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.||Since the previous secondary endpoint (Total fluoroscopy time) was non-significant, testing stopped and this secondary endpoint was not tested.|Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||3.1|-14.4|
91766689|NCT04491136|183422722|OTHER||||||>|0.9999|||||||McNemar|||Occurrence of at least one shock||||>0.9999
91766690|NCT04491136|183422722|OTHER|||||||0.0654|||||||McNemar|||Occurrence of at least one ATP event||||0.0654
91766691|NCT01712204|183422744|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_ERROR_OF_MEAN|0.113||0.1356|TWO_SIDED|95.0|0.62|1.07|||Possion regression|||||1.07|0.62|0.1356
91550954|NCT03334630|182984900|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-0.2||||0.8528|TWO_SIDED|95.0|-1.9|1.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||1.6|-1.9|0.8528
91550955|NCT03474107|182984952|SUPERIORITY||Stratified Hazard Ratio|0.702||||0.00142|TWO_SIDED|95.0|0.556|0.886||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.|Stratified Log rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.886|0.556|0.00142
91550956|NCT03474107|182984953|SUPERIORITY||Stratified Hazard Ratio|0.615|||<|1e-05|TWO_SIDED|95.0|0.505|0.748||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.|Stratified Log Rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.748|0.505|<0.00001
91550957|NCT03474107|182984954|SUPERIORITY||||||<|0.001||||||"Stratification factors were ECOG PS, Region and Liver Metastasis."|Stratified Cochran-Mantel-Haenszel|||||||<0.001
91550958|NCT03474107|182984955|SUPERIORITY||||||<|0.001||||||Stratification factors were ECOG PS, Region and Liver Metastasis.|Stratified Cochran-Mantel-Haenszel|||||||<0.001
91550959|NCT03621371|182985054|OTHER||F-test|9.88|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91550960|NCT02723591|182985079|SUPERIORITY||Odds Ratio (OR)|1.115||||0.5777|TWO_SIDED|95.0|0.76|1.636|||Regression, Logistic|||Logistic regression with DSA/IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant calculated panel reactivity antibody (cPRA) as fixed effects, and pooled site as a random effect with standard variance components covariance type.||1.636|0.760|0.5777
91550961|NCT02723591|182985082|SUPERIORITY|||||||0.6618|||||||Fisher Exact|||P-values obtained from a 2x3 Exact Test of treatment by strength levels.||||0.6618
91550962|NCT02723591|182985087|SUPERIORITY||Odds Ratio (OR)|1.038||||0.8518|TWO_SIDED|95.0|0.7|1.539|||Regression, Logistic|||Logistic regression with IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||1.539|0.700|0.8518
91550963|NCT02723591|182985090|SUPERIORITY|||||||1|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||1.0000
91550964|NCT02723591|182985091|SUPERIORITY|||||||0.475|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.4750
91550965|NCT02723591|182985092|SUPERIORITY|||||||0.0939|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.0939
91550966|NCT02723591|182985095|SUPERIORITY||Odds Ratio (OR)|1.431||||0.116|TWO_SIDED|95.0|0.915|2.24|||Regression, Logistic|||Logistic regression with occurrence of eGFR \< 50 by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.240|0.915|0.1160
91550967|NCT02723591|182985096|SUPERIORITY||Odds Ratio (OR)|1.212||||0.4995|TWO_SIDED|95.0|0.693|2.12|||Regression, Logistic|||Logistic regression with occurrence of 5-point eGFR decline by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.120|0.693|0.4995
91550968|NCT02723591|182985114|SUPERIORITY|||||||0.6327|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6327
91550969|NCT02723591|182985115|SUPERIORITY|||||||0.9701|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9701
91550970|NCT02723591|182985116|SUPERIORITY|||||||0.3127|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.3127
91550971|NCT02723591|182985117|SUPERIORITY|||||||0.083|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.0830
91550972|NCT02723591|182985118|SUPERIORITY|||||||0.6022|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6022
91550973|NCT02723591|182985119|SUPERIORITY|P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||||0.9249|||||||Fisher Exact|||||||0.9249
91550974|NCT02723591|182985120|SUPERIORITY|||||||0.9136|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9136
91550975|NCT02723591|182985121|SUPERIORITY|||||||0.8789|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8789
91550976|NCT02723591|182985122|SUPERIORITY|||||||0.5574|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5574
91550977|NCT02723591|182985123|SUPERIORITY|||||||0.815|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8150
91550978|NCT02723591|182985124|SUPERIORITY|||||||0.5673|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5673
91550979|NCT05469464|182985153|SUPERIORITY||Mean Difference (Net)|-4.6|STANDARD_ERROR_OF_MEAN|6.93||0.505|TWO_SIDED|95.0|-18.2|9.0|||ANCOVA|||||9.0|-18.2|0.505
91550980|NCT05469464|182985153|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|7.15||0.812|TWO_SIDED|95.0|-15.8|12.3|||ANCOVA|||||12.3|-15.8|0.812
91766692|NCT01059318|183422749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.0|||||TWO_SIDED|95.0|-45.0|196.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||196|-45|
91766693|NCT01059318|183422750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|186.0|||||TWO_SIDED|95.0|93.0|279.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||279|93|
91766694|NCT02267538|183422762|OTHER||Odds Ratio (OR)|0.62||||0.341|TWO_SIDED|95.0|0.23|1.65|||Regression, Logistic|||||1.65|0.23|0.341
91766695|NCT02267538|183422763|OTHER||Median Difference (Final Values)|0.0||||0.83|TWO_SIDED|||||MMSE|Wilcoxon (Mann-Whitney)|||||||0.830
91766696|NCT02267538|183422763|OTHER||Median Difference (Final Values)|0.0||||0.405|TWO_SIDED|||||m-TICS|Wilcoxon (Mann-Whitney)|||||||0.405
91766697|NCT02267538|183422764|OTHER||Odds Ratio (OR)|0.74||||0.214|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||Incidence of total non-delirium complications within 30 days after surgery||1.19|0.47|0.214
91766698|NCT02267538|183422764|OTHER|stroke|Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08|||Regression, Logistic|||Incidence of stroke within 30 days after surgery||5.08|0.20|0.993
91766699|NCT02267538|183422764|OTHER|New onset arrythmia|Odds Ratio (OR)|0.76||||0.274|TWO_SIDED|95.0|0.46|1.25|||Regression, Logistic|||||1.25|0.46|0.274
91766700|NCT02267538|183422764|OTHER|Pulmonary complications|Odds Ratio (OR)|0.51||||0.05|TWO_SIDED|95.0|0.26|1.0|||Regression, Logistic|||||1.00|0.26|0.050
91766701|NCT02267538|183422764|OTHER||Odds Ratio (OR)|0.5||||0.423|TWO_SIDED|95.0|0.09|2.75||Upper gastrointestinal bleeding|Regression, Logistic|||||2.75|0.09|0.423
91766702|NCT02267538|183422764|OTHER||Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08||Surgical bleeding|Regression, Logistic|||||5.08|0.20|0.993
91766703|NCT02267538|183422764|OTHER||Odds Ratio (OR)|1.63||||0.326|TWO_SIDED|95.0|0.61|4.34||Wound dehiscence or infection|Regression, Logistic|||||4.34|0.61|0.326
91766704|NCT02267538|183422764|OTHER||Odds Ratio (OR)|0.79||||0.378|TWO_SIDED|95.0|0.47|1.33||Acute kidney injur|Regression, Logistic|||||1.33|0.47|0.378
91766705|NCT02267538|183422764|OTHER||Odds Ratio (OR)|0.48||||0.156|TWO_SIDED|95.0|0.18|1.32||IABP assistance|Regression, Logistic|||||1.32|0.18|0.156
91766706|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.596|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL group||0|-1|0.596
91766707|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.743|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL group||0|-1|0.743
91766708|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.282|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group||0|-1|0.282
91766709|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.368|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group||0|0|0.368
91766710|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.397|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group||0|0|0.397
91766711|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.486|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.486
91766712|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.414
91766713|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.187|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.187
91766714|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.127|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.127
91766715|NCT02267538|183422765|OTHER||Median Difference (Final Values)|0.0||||0.378|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group||0|0|0.378
91766716|NCT02267538|183422766|OTHER||Median Difference (Final Values)|0.0||||0.777|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL group||0|0|0.777
91766717|NCT02267538|183422766|OTHER||Median Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL group||1|-1|0.919
91550981|NCT05469464|182985153|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|6.99||0.118|TWO_SIDED|95.0|-24.6|2.8|||ANCOVA|||||2.8|-24.6|0.118
91550982|NCT04068311|182985339|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
91550983|NCT04068311|182985340|SUPERIORITY|||||||0.83||||||unadjusted|Chi-squared|||||||0.83
91550984|NCT04068311|182985341|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
91550985|NCT04068311|182985342|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91550986|NCT03100149|182985407|SUPERIORITY||Difference in Adjusted Means|-2.02|STANDARD_ERROR_OF_MEAN|1.71||0.2385|TWO_SIDED|80.0|-4.21|0.18|||Mixed Models Analysis|||||0.18|-4.21|0.2385
91550987|NCT03100149|182985407|SUPERIORITY||Difference in Adjusted Means|-0.62|STANDARD_ERROR_OF_MEAN|1.71||0.7169|TWO_SIDED|80.0|-2.82|1.58|||Mixed Models Analysis|||||1.58|-2.82|0.7169
91550988|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6116|TWO_SIDED|80.0|-0.3|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.13|-0.30|0.6116
91550989|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6188|TWO_SIDED|80.0|-0.13|0.3||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.30|-0.13|0.6188
91550990|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.04|STANDARD_ERROR_OF_MEAN|0.345||0.9062|TWO_SIDED|80.0|-0.48|0.4||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.40|-0.48|0.9062
91550991|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.347||0.9621|TWO_SIDED|80.0|-0.43|0.46||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.46|-0.43|0.9621
91550992|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.411||0.651|TWO_SIDED|80.0|-0.71|0.34||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.34|-0.71|0.6510
91550993|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.413||0.7709|TWO_SIDED|80.0|-0.41|0.65||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.65|-0.41|0.7709
91550994|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|0.34|STANDARD_ERROR_OF_MEAN|0.523||0.5177|TWO_SIDED|80.0|-0.33|1.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||1.01|-0.33|0.5177
91550995|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.06|STANDARD_ERROR_OF_MEAN|0.523||0.9095|TWO_SIDED|80.0|-0.73|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||0.61|-0.73|0.9095
91550996|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-1.88|STANDARD_ERROR_OF_MEAN|1.255||0.1354|TWO_SIDED|80.0|-3.49|-0.27||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||-0.27|-3.49|0.1354
91550997|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-1.02|STANDARD_ERROR_OF_MEAN|1.262||0.4217|TWO_SIDED|80.0|-2.64|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||0.61|-2.64|0.4217
91550998|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.369||0.8053|TWO_SIDED|80.0|-0.38|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.56|-0.38|0.8053
91550999|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.37||0.497|TWO_SIDED|80.0|-0.22|0.73||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.73|-0.22|0.4970
91551000|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-1.07|STANDARD_ERROR_OF_MEAN|0.779||0.1703|TWO_SIDED|80.0|-2.07|-0.07||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||-0.07|-2.07|0.1703
91551001|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.44|STANDARD_ERROR_OF_MEAN|0.782||0.5729|TWO_SIDED|80.0|-1.45|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||0.56|-1.45|0.5729
91551002|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.61|STANDARD_ERROR_OF_MEAN|0.324||0.0628|TWO_SIDED|80.0|-1.02|-0.19||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||-0.19|-1.02|0.0628
91551003|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.41|STANDARD_ERROR_OF_MEAN|0.325||0.2125|TWO_SIDED|80.0|-0.82|0.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||0.01|-0.82|0.2125
91551004|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4577|TWO_SIDED|80.0|-0.22|0.06||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.06|-0.22|0.4577
91551005|NCT03100149|182985408|SUPERIORITY||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.109||0.9182|TWO_SIDED|80.0|-0.15|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.13|-0.15|0.9182
91551006|NCT03100149|182985409|SUPERIORITY||LS Means Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3582|TWO_SIDED|80.0|-0.05|0.01||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.01|-0.05|0.3582
91551007|NCT03100149|182985409|SUPERIORITY||LS Means Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1955|TWO_SIDED|80.0|-0.06|0.0||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.00|-0.06|0.1955
91551008|NCT03100149|182985410|SUPERIORITY||Difference in Adjusted Means|0.22|STANDARD_ERROR_OF_MEAN|0.245||0.3611|TWO_SIDED|80.0|-0.09|0.54||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.54|-0.09|0.3611
91551009|NCT03100149|182985410|SUPERIORITY||Difference in Adjusted Means|0.44|STANDARD_ERROR_OF_MEAN|0.243||0.0727|TWO_SIDED|80.0|0.13|0.75||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.75|0.13|0.0727
91551010|NCT03100149|182985411|SUPERIORITY||Odds Ratio (OR)|0.77||||0.4265|TWO_SIDED|80.0|0.5|1.18||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.18|0.50|0.4265
91551011|NCT03100149|182985411|SUPERIORITY||Odds Ratio (OR)|0.76||||0.4063|TWO_SIDED|80.0|0.49|1.16||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.16|0.49|0.4063
91551012|NCT03100149|182985412|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3847|TWO_SIDED|80.0|0.48|1.15||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.15|0.48|0.3847
91551013|NCT03100149|182985412|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7055|TWO_SIDED|80.0|0.57|1.36||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.36|0.57|0.7055
91551014|NCT03100149|182985413|SUPERIORITY||Difference in Adjusted Means|-0.73|STANDARD_ERROR_OF_MEAN|0.888||0.4142|TWO_SIDED|80.0|-1.87|0.41||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.41|-1.87|0.4142
91551015|NCT03100149|182985413|SUPERIORITY||Difference in Adjusted Means|-0.67|STANDARD_ERROR_OF_MEAN|0.885||0.4486|TWO_SIDED|80.0|-1.81|0.47||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.47|-1.81|0.4486
91551016|NCT03100149|182985414|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3769|TWO_SIDED|80.0|0.94|1.42||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.42|0.94|0.3769
91551017|NCT03100149|182985414|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1658|TWO_SIDED|80.0|1.02|1.53||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.53|1.02|0.1658
91551018|NCT03100149|182985415|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9542|TWO_SIDED|80.0|0.77|1.33||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.33|0.77|0.9542
91551019|NCT03100149|182985415|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4567|TWO_SIDED|80.0|0.63|1.13||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.13|0.63|0.4567
91551020|NCT02296125|182985476|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.37|0.57|||Log Rank|||||0.57|0.37|<0.0001
91551021|NCT02296125|182985476|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.56||||0.0065|TWO_SIDED|95.0|0.37|0.85|||Log Rank|||||0.85|0.37|0.0065
91551022|NCT02296125|182985478|SUPERIORITY||Odds Ratio (OR)|1.51||||0.036|TWO_SIDED|95.0|1.03|2.22|||Regression, Logistic|||||2.22|1.03|0.036
91551023|NCT02296125|182985478|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.31||||0.485|TWO_SIDED|95.0|0.61|2.84|||Regression, Logistic|||||2.84|0.61|0.485
91551024|NCT02296125|182985479|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|2.48||||0.0133|TWO_SIDED|95.0|1.21|5.09|||Regression, Linear|||||5.09|1.21|0.0133
91551025|NCT02296125|182985479|SUPERIORITY||Mean Difference (Final Values)|2.27|||<|0.0001|TWO_SIDED|95.0|1.68|3.08|||Regression, Linear|||||3.08|1.68|<0.0001
91551026|NCT02296125|182985480|SUPERIORITY||Odds Ratio (OR)|2.78||||0.011|TWO_SIDED|95.0|1.25|6.78|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||6.78|1.25|0.0110
91551027|NCT02296125|182985480|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.67||||0.5772|TWO_SIDED|95.0|0.27|12.98|||Regression, Logistic||An odds ratio \>1 favours osimertinib|||12.98|0.27|0.5772
91551028|NCT02296125|182985481|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0025|TWO_SIDED|95.0|-11.205|-2.403|||Regression, Linear|||||-2.403|-11.205|0.0025
91551029|NCT02296125|182985481|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|-6.59||||0.1348|TWO_SIDED|95.0|-15.246|2.072|||Regression, Linear|||||2.072|-15.246|0.1348
91551030|NCT02296125|182985482|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.0462|TWO_SIDED|95.0|0.6409|0.9963|||Log Rank|||||0.9963|0.6409|0.0462
91551031|NCT02296125|182985482|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.848||||0.4416|TWO_SIDED|95.0|0.5568|1.291|||Log Rank|||||1.2910|0.5568|0.4416
91551032|NCT01733316|182985540|SUPERIORITY|||||||0.0048||||||Paired t-test testing the null hypothesis that the population average difference during the Cystagon® phase is equal to the population average difference during the RP103 phase.|Paired t-test, two-sided|||||||0.0048
91551033|NCT02606422|182985569|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91551034|NCT04625465|182985590|OTHER||Difference in the log odds ratios|0.042||||0.869|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.869
91551035|NCT04625465|182985591|OTHER||Difference in the log odds ratios|-0.32||||0.21|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.210
91551036|NCT05566639|182985600|NON_INFERIORITY|Noninferiority margin = 10%|Relative vaccine efficacy (rVE)|1.7||||0.1715|TWO_SIDED|95.0|-24.1|22.2|||Stratified Cox proportional hazards||rVE = 100 \* (1 - HR) % was defined as the percent reduction in the hazard (mRNA-1010 vs active comparator), where HR was the hazard ratio between mRNA-1010 vs the active comparator.|||22.2|-24.1|0.1715
91551037|NCT03952338|182985685|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.97|TWO_SIDED|95.0|-4.07|3.93|||Mixed Models Analysis|||||3.93|-4.07|0.97
91551038|NCT03952338|182985686|SUPERIORITY||Mean Difference (Final Values)|1.22||||0.57|TWO_SIDED|95.0|-3.0|5.44|||Mixed Models Analysis|||||5.44|-3.00|0.57
91551039|NCT03952338|182985687|SUPERIORITY||Mean Difference (Final Values)|1.96||||0.09|TWO_SIDED|95.0|-0.32|4.23|||Mixed Models Analysis|||||4.23|-0.32|0.09
91551040|NCT03952338|182985688|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.08|TWO_SIDED|95.0|-0.22|4.43|||Mixed Models Analysis|||||4.43|-0.22|0.08
91551041|NCT03952338|182985689|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.09|TWO_SIDED|95.0|-0.17|2.46|||Mixed Models Analysis|||||2.46|-0.17|0.09
91551042|NCT03952338|182985690|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.95|TWO_SIDED|95.0|-1.39|1.3|||Mixed Models Analysis|||||1.30|-1.39|0.95
91551043|NCT03952338|182985691|SUPERIORITY||Odds Ratio (OR)|0.21||||0.01|TWO_SIDED|95.0|0.06|0.7|||Regression, Logistic|||||0.70|0.06|0.01
91551044|NCT03952338|182985692|SUPERIORITY||Odds Ratio (OR)|0.29||||0.04|TWO_SIDED|95.0|0.09|0.96|||Regression, Logistic|||||0.96|0.09|0.04
91551045|NCT03952338|182985693|SUPERIORITY||Odds Ratio (OR)|2.11||||0.236|TWO_SIDED|95.0|0.27|7.23|||Regression, Logistic|||||7.23|0.27|0.236
91551046|NCT03952338|182985694|SUPERIORITY||Odds Ratio (OR)|2.22||||0.22|TWO_SIDED|95.0|0.62|7.97|||Regression, Logistic|||||7.97|0.62|0.220
91551047|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.7|TWO_SIDED|95.0|-0.37|0.55|||Mixed Models Analysis|||Total vegetables||0.55|-0.37|0.70
91551048|NCT03952338|182985695|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.85|TWO_SIDED|95.0|-0.84|0.69|||Mixed Models Analysis|||Greens and beans||0.69|-0.84|0.85
91551049|NCT03952338|182985695|SUPERIORITY|Total fruits|Mean Difference (Final Values)|0.34||||0.29|TWO_SIDED|95.0|-0.29|0.98|||Mixed Models Analysis|||||0.98|-0.29|0.29
91551050|NCT03952338|182985695|SUPERIORITY||Median Difference (Final Values)|0.6||||0.07|TWO_SIDED|95.0|-0.06|1.26|||Mixed Models Analysis|||Whole fruits||1.26|-0.06|0.07
91551051|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.92|TWO_SIDED|95.0|-1.16|1.05|||Mixed Models Analysis|||Whole grains||1.05|-1.16|0.92
91551052|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED|95.0|-1.29|0.89|||Mixed Models Analysis|||Dairy||0.89|-1.29|0.72
91551053|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.15|TWO_SIDED|95.0|-0.12|0.74|||Mixed Models Analysis|||Total protein||0.74|-0.12|0.15
91551054|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.92|TWO_SIDED|95.0|-0.78|0.71|||Mixed Models Analysis|||Seafood and plant proteins||0.71|-0.78|0.92
91551055|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.67|TWO_SIDED|95.0|-1.47|0.94|||Mixed Models Analysis|||Fatty acids||0.94|-1.47|0.67
91551056|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.45|0.84|||Mixed Models Analysis|||Sodium||0.84|-1.45|0.61
91551057|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|-1.15||||0.06|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Analysis|||Refined grains||0.04|-2.34|0.06
91551058|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.32|TWO_SIDED|95.0|-0.51|1.57|||Mixed Models Analysis|||Saturated fats||1.57|-0.51|0.32
91551059|NCT03952338|182985695|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.63|TWO_SIDED|95.0|-0.56|0.92|||Mixed Models Analysis|||Added sugars||0.92|-0.56|0.63
91766718|NCT02267538|183422766|OTHER||Median Difference (Final Values)|0.0||||0.835|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group||0|0|0.835
91766719|NCT02267538|183422766|OTHER||Median Difference (Final Values)|0.0||||0.321|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group||0|0|0.321
91551060|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.85|TWO_SIDED|95.0|-0.61|0.5|||Mixed Models Analysis|||Total vegetables||0.50|-0.61|0.85
91551061|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.82|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Greens and beans||0.70|-0.88|0.82
91551062|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.48|TWO_SIDED|95.0|-0.43|0.93|||Mixed Models Analysis|||Total fruits||0.93|-0.43|0.48
91551063|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.06|TWO_SIDED|95.0|-0.04|1.46|||Mixed Models Analysis|||Whole fruits||1.46|-0.04|0.06
91551064|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.34|TWO_SIDED|95.0|-0.63|1.84|||Mixed Models Analysis|||Whole grains||1.84|-0.63|0.34
91551065|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.01|TWO_SIDED|95.0|0.31|2.62|||Mixed Models Analysis|||Dairy||2.62|0.31|0.01
91551066|NCT03952338|182985696|SUPERIORITY||Median Difference (Final Values)|0.21||||0.39|TWO_SIDED|95.0|-0.27|0.69|||Mixed Models Analysis|||Total protein||0.69|-0.27|0.39
91551067|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.81|TWO_SIDED|95.0|-0.9|0.7|||Mixed Models Analysis|||Seafood and plant proteins||0.70|-0.90|0.81
91551068|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.04|TWO_SIDED|95.0|-2.57|-0.04|||Mixed Models Analysis|||Fatty acids||-0.04|-2.57|0.04
91551069|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.25|TWO_SIDED|95.0|-1.86|0.48|||Mixed Models Analysis|||Sodium||0.48|-1.86|0.25
91551070|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|95.0|-1.25|1.4|||Mixed Models Analysis|||Refined grains||1.40|-1.25|0.91
91551071|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.89|TWO_SIDED|95.0|-0.98|1.13|||Mixed Models Analysis|||Saturated fats||1.13|-0.98|0.89
91551072|NCT03952338|182985696|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.59|TWO_SIDED|95.0|-0.55|0.97|||Mixed Models Analysis|||Added sugars||0.97|-0.55|0.59
91551073|NCT03952338|182985697|SUPERIORITY||Risk Ratio (RR)|0.15||||0.01|TWO_SIDED|95.0|0.03|0.67||Marginal food insecurity|Mixed Models Analysis|Mixed effects multinomial logistic regression||||0.67|0.03|0.01
91551074|NCT03952338|182985697|SUPERIORITY||Risk Ratio (RR)|0.56||||0.34|TWO_SIDED|95.0|0.17|1.82|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||1.82|0.17|0.34
91551075|NCT03952338|182985697|SUPERIORITY||Risk Ratio (RR)|0.16||||0.02|TWO_SIDED|95.0|0.03|0.76|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.76|0.03|0.02
91551076|NCT03952338|182985698|SUPERIORITY||Risk Ratio, log|0.28||||0.1|TWO_SIDED|95.0|0.06|1.29|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Marginal food insecurity||1.29|0.06|0.10
91551077|NCT03952338|182985698|SUPERIORITY||Risk Ratio (RR)|0.68||||0.52|TWO_SIDED|95.0|0.21|2.21|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||2.21|0.21|0.52
91551078|NCT03952338|182985698|SUPERIORITY||Risk Ratio (RR)|0.11||||0.01|TWO_SIDED|95.0|0.02|0.56|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.56|0.02|0.01
91551079|NCT03952338|182985699|SUPERIORITY||Risk Ratio (RR)|2.94||||0.15|TWO_SIDED|95.0|0.68|12.66|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||12.66|0.68|0.15
91551080|NCT03952338|182985699|SUPERIORITY||Risk Ratio (RR)|1.18||||0.86|TWO_SIDED|95.0|0.2|7.13|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||7.13|0.20|0.86
91551081|NCT03952338|182985700|SUPERIORITY||Risk Ratio (RR)|1.28||||0.74|TWO_SIDED|95.0|0.31|5.38|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||5.38|0.31|0.74
91551082|NCT03952338|182985700|SUPERIORITY||Risk Ratio (RR)|5.48||||0.1|TWO_SIDED|95.0|0.73|41.3|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||41.3|0.73|0.10
91551083|NCT03952338|182985701|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.64|TWO_SIDED|95.0|-0.65|0.4|||Mixed Models Analysis|||||0.40|-0.65|0.64
91551084|NCT03952338|182985702|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9|TWO_SIDED|95.0|-0.57|0.5|||Mixed Models Analysis|||||0.50|-0.57|0.90
91551085|NCT03952338|182985703|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.43|TWO_SIDED|95.0|-14.05|5.92||Males|Mixed Models Analysis|||||5.92|-14.05|0.43
91551086|NCT03952338|182985703|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.83|TWO_SIDED|95.0|-3.75|4.66|||Mixed Models Analysis|||Females||4.66|-3.75|0.83
91766720|NCT02267538|183422766|OTHER||Median Difference (Final Values)|0.0||||0.174|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group||0|0|0.174
91766721|NCT02267538|183422767|OTHER||Hazard Ratio (HR)|1.03||||0.788|TWO_SIDED|95.0|0.82|1.31|||Log Rank|||||1.31|0.82|0.788
91551087|NCT03952338|182985704|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.66|TWO_SIDED|95.0|-5.65|3.57||Age 18-59 years|Mixed Models Analysis|||||3.57|-5.65|0.66
91551088|NCT03952338|182985704|SUPERIORITY||Mean Difference (Final Values)|3.28||||0.4|TWO_SIDED|95.0|-4.36|10.93|||Mixed Models Analysis|||Age 60+ years||10.93|-4.36|0.40
91551089|NCT03952338|182985705|SUPERIORITY||Mean Difference (Final Values)|6.25||||0.43|TWO_SIDED|95.0|-9.13|21.63|||Mixed Models Analysis|||Males||21.63|-9.13|0.43
91551090|NCT03952338|182985705|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.62|TWO_SIDED|95.0|-3.23|5.41|||Mixed Models Analysis|||Females||5.41|-3.23|0.62
91551091|NCT03952338|182985706|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.99|TWO_SIDED|95.0|-4.76|4.66|||Mixed Models Analysis|||18-59 years||4.66|-4.76|0.99
91551092|NCT03952338|182985706|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.43|TWO_SIDED|95.0|-5.48|12.8|||Mixed Models Analysis|||60+ years||12.80|-5.48|0.43
91551093|NCT01456949|182985713|SUPERIORITY||Kaplan-Meier (product-limit) estimator|66.9|||<|0.001|TWO_SIDED|95.0|61.6|71.7|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||71.7|61.6|<0.001
91551094|NCT01456949|182985714|SUPERIORITY||Kaplan-Meier (product-limit) estimator|2.3|||<|0.001|TWO_SIDED|95.0|1.1|4.5|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.5|1.1|<0.001
91551095|NCT01456949|182985715|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Freedom from MAFE's was estimated using Kaplan-Meier methods.|||
91551096|NCT01456949|182985716|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Chronic treatment success was estimated at one and two years using Kaplan-Meier methods.|||
91551097|NCT04753697|182985717|SUPERIORITY||Difference in Least Square Mean|-1.91|STANDARD_ERROR_OF_MEAN|0.544||0.0005|TWO_SIDED|95.0|-2.97|-0.84|||ANCOVA|||||-0.84|-2.97|0.0005
91551098|NCT04753697|182985718|SUPERIORITY||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|20.6|32.2|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||32.2|20.6|<0.0001
91551099|NCT04753697|182985719|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|18.4|||<|0.0001|TWO_SIDED|95.0|11.3|25.5|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||25.5|11.3|<0.0001
91551100|NCT04753697|182985719|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|17.0|||<|0.0001|TWO_SIDED|95.0|10.1|24.0||Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.|Cochran-Mantel-Haenszel|||||24.0|10.1|<0.0001
91551101|NCT04753697|182985720|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|40.0|||<|0.0001|TWO_SIDED|95.0|33.3|46.7|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status||||46.7|33.3|<0.0001
91551102|NCT04753697|182985721|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|25.7|||<|0.0001|TWO_SIDED|95.0|17.8|33.6|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||33.6|17.8|<0.0001
91551103|NCT04753697|182985721|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|27.7|||<|0.0001|TWO_SIDED|95.0|19.7|35.7|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||35.7|19.7|<0.0001
91551104|NCT04753697|182985722|SUPERIORITY||DIFFERENCE IN LSM|-2.26|STANDARD_ERROR_OF_MEAN|0.655||0.0006|TWO_SIDED|95.0|-3.55|-0.98|||ANCOVA|||||-0.98|-3.55|0.0006
91551105|NCT04753697|182985722|SUPERIORITY||DIFFERENCE IN LSM|-2.49|STANDARD_ERROR_OF_MEAN|0.657||0.0002||95.0|-3.78|-1.2|||ANCOVA|||||-1.20|-3.78|0.0002
91551106|NCT04753697|182985723|SUPERIORITY||DIFFERENCE IN LSM|-4.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-4.8|-3.2|||ANCOVA|||||-3.2|-4.8|<0.0001
91551107|NCT04753697|182985724|SUPERIORITY||DIFFERENCE IN LSM|-3.5|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.5|-2.4|||ANCOVA|||||-2.4|-4.5|<0.0001
91551108|NCT04753697|182985724|SUPERIORITY||DIFFERENCE IN LSM|-3.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.1|-2.1|||ANCOVA|||||-2.1|-4.1|<0.0001
91766722|NCT02267538|183422768|OTHER||Hazard Ratio (HR)|0.97||||0.826|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||||1.23|0.77|0.826
91766723|NCT01223183|183422776|EQUIVALENCE|alpha=0.05|||||<|0.001|||||||t-test, 2 sided|||Comparing DTPA absorption after hypertonic saline inhalation to DTPA absorption after isotonic saline inhalation||||<0.001
91766724|NCT01223183|183422778|EQUIVALENCE|alpha=0.05||||||0.003|||||||t-test, 2 sided|||Comparing mucociliary clearance after isotonic saline inhalation to mucociliary clearance after hypertonic saline inhalation||||0.003
91766725|NCT01454791|183422780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
91766726|NCT01454791|183422781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.6059|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.6059
91766727|NCT01454791|183422782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.705|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.705
91551109|NCT04753697|182985725|SUPERIORITY||DIFFERENCE IN LSM|-22.51|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|95.0|-25.5|-19.51|||ANCOVA|||||-19.51|-25.50|<0.0001
91551110|NCT04753697|182985726|SUPERIORITY||DIFFERENCE IN LSM|-18.13|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.85|-14.4|||ANCOVA|||||-14.40|-21.85|<0.0001
91551111|NCT04753697|182985726|SUPERIORITY||DIFFERENCE IN LSM|-19.22|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-22.9|-15.53|||ANCOVA|||||-15.53|-22.90|<0.0001
91551112|NCT04753697|182985727|SUPERIORITY||DIFFERENCE IN LSM|-25.4|STANDARD_ERROR_OF_MEAN|1.793|<|0.0001|TWO_SIDED|95.0|-28.92|-21.89|||ANCOVA|||||-21.89|-28.92|<0.0001
91551113|NCT04753697|182985728|SUPERIORITY||DIFFERENCE IN LSM|-20.82|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|-25.17|-18.91|||Cochran-Mantel-Haenszel|||||-18.91|-25.17|<0.0001
91551114|NCT04753697|182985728|SUPERIORITY||DIFFERENCE IN LSM|-23.43|STANDARD_ERROR_OF_MEAN|2.222|<|0.0001|TWO_SIDED|95.0|-27.73|-21.56|||ANCOVA|||||-21.56|-27.73|<0.0001
91551115|NCT04753697|182985729|SUPERIORITY||DIFFERENCE IN LSM|-4.1|STANDARD_ERROR_OF_MEAN|1.174||0.0005|TWO_SIDED|95.0|-6.4|-1.8|||ANCOVA|||||-1.80|-6.40|0.0005
91551116|NCT04753697|182985730|SUPERIORITY||DIFFERENCE IN LSM|-4.35|STANDARD_ERROR_OF_MEAN|1.42||0.0022|TWO_SIDED|95.0|-7.14|-1.57|||ANCOVA|||||-1.57|-7.14|0.0022
91551117|NCT04753697|182985730|SUPERIORITY||Difference in LSM|-5.2|STANDARD_ERROR_OF_MEAN|1.425||0.0003|TWO_SIDED|95.0|-8.0|-2.41|||ANCOVA|||||-2.41|-8.00|0.0003
91551118|NCT04753697|182985731|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|16.9||||0.0016|TWO_SIDED|95.0|6.7|27.2|||ANCOVA|||||27.2|6.7|0.0016
91766728|NCT02719171|183422783|OTHER||Mean Difference (Final Values)|24.0||||0.007|TWO_SIDED|90.0|9.3|38.7|||Cochran-Mantel-Haenszel|||The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.||38.7|9.3|0.007
91551119|NCT01658930|182985750|NON_INFERIORITY|Margin of inferiority in the difference of 3 year pelvic recurrence rates between simple and radical hysterectomy group was 4%.|Mean Difference (Final Values)|0.0035|||||TWO_SIDED|90.0|-0.0162|0.0232|||||Difference between simple and radical hysterectomy groups.|||0.0232|-0.0162|
91551120|NCT01658930|182985751|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.67|||||Hazard ratio of simple to radical hysterectomy.|||2.67|0.47|
91551121|NCT01658930|182985752|SUPERIORITY||Hazard Ratio (HR)|3.82|||||TWO_SIDED|95.0|0.79|18.4|||||Hazard ratio is simple hysterectomy group of radical hysterectomy group.|||18.4|0.79|
91551122|NCT01658930|182985753|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.69|3.45|||||Hazard ratio is simple hysterectomy group to radical hysterectomy group.|||3.45|0.69|
91551123|NCT01658930|182985754|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.38|3.14|||||Hazard ratio of simple to radical hysterectomy.|||3.14|0.38|
91766729|NCT02719171|183422784|OTHER||Mean Difference (Final Values)|12.0||||0.074|TWO_SIDED|90.0|1.0|23.0|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||23.0|1.0|0.074
91551124|NCT05446168|182985846|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-0.08|STANDARD_DEVIATION|0.05||0.005|TWO_SIDED|95.0|-0.12|-0.03||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = -4.05, df = 7||||-0.03|-0.12|0.005
91551125|NCT05446168|182985847|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis.|Mean Difference (Net)|4.33|STANDARD_DEVIATION|12.81||0.27|TWO_SIDED|95.0|-3.81|12.47||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = 1.17, df = 11||||12.47|-3.81|0.27
91551126|NCT01828099|182985848|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.73|||Log Rank|||||0.73|0.42|<0.001
91551127|NCT05875467|182985874|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||.042
91766730|NCT02719171|183422784|OTHER||Mean Difference (Final Values)|19.0||||0.007|TWO_SIDED|90.0|7.4|30.6|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||30.6|7.4|0.007
91551128|NCT05875467|182985875|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||.928
91551129|NCT05875467|182985876|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||.022
91551130|NCT05875467|182985877|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
91551131|NCT06473662|182985899|OTHER||Mean Difference (Final Values)|-0.53||||0.0039|TWO_SIDED||||||t-test, 2 sided|||||||0.0039
91551132|NCT06473662|182985900|OTHER||Mean Difference (Final Values)|-18.8||||0.0166|TWO_SIDED||||||t-test, 2 sided|||||||0.0166
91551133|NCT06473662|182985902|OTHER||Mean Difference (Final Values)|-22.13||||0.0474|TWO_SIDED||||||ANCOVA|||||||0.0474
91551134|NCT02398656|182985903|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.88|1.04||||||||1.04|0.88|
91551135|NCT05602220|182985905|SUPERIORITY||F test|0.054||||0.817|TWO_SIDED||||||ANOVA|||||||0.817
91551136|NCT05602220|182985906|SUPERIORITY||F test|2.162||||0.147|TWO_SIDED||||||ANOVA|||||||0.147
91551137|NCT05602220|182985907|SUPERIORITY||F test|2.88||||0.096|TWO_SIDED||||||ANOVA|||||||0.096
91551138|NCT05602220|182985908|SUPERIORITY||F test|0.449||||0.64|TWO_SIDED||||||ANCOVA|||||||0.640
91551139|NCT05602220|182985909|SUPERIORITY|"Linear mixed-effects model fit to participants' latent performance scores across 10 time bins.~Comparison of performance changes over time between groups."|beta parameter|0.0001419|STANDARD_ERROR_OF_MEAN|0.036816||0.997|TWO_SIDED|95.0|-0.072164|0.072448|||Mixed Models Analysis|||||0.072448|-0.072164|0.997
91551140|NCT05321082|182985929|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0507|TWO_SIDED|95.0|0.61|1.0|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment, baseline intake of AF (nintedanib) treatment, baseline HRCT pattern, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (corrected for hemoglobin) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||1.00|0.61|0.0507
91766731|NCT02719171|183422785|OTHER||Mean Difference (Final Values)|10.3||||0.006|TWO_SIDED|90.0|4.1|16.4|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||16.4|4.1|0.006
91551141|NCT05321082|182985929|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0395|TWO_SIDED|95.0|0.6|0.99|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment, baseline intake of AF (nintedanib) treatment, baseline HRCT pattern, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (corrected for hemoglobin) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||0.99|0.60|0.0395
91551142|NCT05321082|182985930|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0258|TWO_SIDED|95.0|0.51|0.96|||Regression, Cox|||Analysis performed using a Cox proportional hazards model that included baseline antifibrotic therapy (AF group vs non-AF group), baseline HRCT pattern, age, baseline FVC % predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (corrected for Hb) and treatment as covariates.||0.96|0.51|0.0258
91551143|NCT05321082|182985930|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0017|TWO_SIDED|95.0|0.43|0.82|||Regression, Cox|||Analysis performed using a Cox proportional hazards model that included baseline antifibrotic therapy (AF group vs non-AF group), baseline HRCT pattern, age, baseline FVC % predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (corrected for Hb) and treatment as covariates.||0.82|0.43|0.0017
91551144|NCT05321082|182985931|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0237|TWO_SIDED|95.0|0.57|0.96|||Regression, Cox|||Analysis performed using a Cox proportional hazards model that included baseline antifibrotic therapy (AF group vs non-AF group), baseline HRCT pattern, age, baseline FVC % predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (corrected for Hb) and treatment as covariates.||0.96|0.57|0.0237
91551145|NCT05321082|182985931|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0427|TWO_SIDED|95.0|0.59|0.99|||Regression, Cox|||Analysis performed using a Cox proportional hazards model that included baseline antifibrotic therapy (AF group vs non-AF group), baseline HRCT pattern, age, baseline FVC % predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (corrected for Hb) and treatment as covariates.||0.99|0.59|0.0427
91551146|NCT05321082|182985932|SUPERIORITY||Mean Difference (Net)|81.14|||<|0.0001|TWO_SIDED|95.0|45.95|116.32|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nerandomilast 9 mg group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline FVC \[mL\] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||116.32|45.95|<0.0001
91551147|NCT05321082|182985932|SUPERIORITY||Mean Difference (Net)|67.18||||0.0002|TWO_SIDED|95.0|31.91|102.46|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nerandomilast 18 mg group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline FVC \[mL\] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||102.46|31.91|0.0002
91551148|NCT05321082|182985933|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0017|TWO_SIDED|95.0|0.34|0.78|||Regression, Cox|||Analysis performed using a Cox proportional hazards model that included baseline antifibrotic therapy (AF group vs non-AF group), baseline HRCT pattern, age, baseline FVC % predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (corrected for Hb) and treatment as covariates.||0.78|0.34|0.0017
91551149|NCT05321082|182985933|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0018|TWO_SIDED|95.0|0.34|0.78|||Regression, Cox|||Analysis performed using a Cox proportional hazards model that included baseline antifibrotic therapy (AF group vs non-AF group), baseline HRCT pattern, age, baseline FVC % predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted (corrected for Hb) and treatment as covariates.||0.78|0.34|0.0018
91551150|NCT05321082|182985934|SUPERIORITY||Mean Difference (Net)|2.19|||<|0.0001|TWO_SIDED|95.0|1.15|3.23|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in predicted Forced Vital Capacity % between the Nerandomilast 9 mg group and the Placebo group at Week 52.|Based on MMRM, with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline FVC \[% pred\] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||3.23|1.15|<0.0001
91551151|NCT05321082|182985934|SUPERIORITY||Mean Difference (Net)|1.94||||0.0003|TWO_SIDED|95.0|0.9|2.98|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in predicted Forced Vital Capacity % between the Nerandomilast 18 mg group and the Placebo group at Week 52.|Based on MMRM, with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline FVC \[% pred\] at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||2.98|0.90|0.0003
91551152|NCT05321082|182985935|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0018|TWO_SIDED|95.0|0.54|0.87|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), baseline HRCT pattern, age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||0.87|0.54|0.0018
91551153|NCT05321082|182985935|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0038|TWO_SIDED|95.0|0.56|0.89|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), baseline HRCT pattern, age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||0.89|0.56|0.0038
91551154|NCT05321082|182985936|SUPERIORITY||Mean Difference (Net)|-0.9||||0.3793|TWO_SIDED|95.0|-2.9|1.11|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in DLCO \[% pred\] between the Nerandomilast 9 mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline DLCO \[% pred\] at each visit. An unstructured covariance structure was used to model repeated measures within patients. Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form page (CRF), was included as a covariate.||1.11|-2.90|0.3793
91551155|NCT05321082|182985936|SUPERIORITY||Mean Difference (Net)|-0.49||||0.6354|TWO_SIDED|95.0|-2.5|1.53|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in DLCO \[% pred\] between the Nerandomilast 18 mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline DLCO \[% pred\] at each visit. An unstructured covariance structure was used to model repeated measures within patients. Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form page (CRF), was included as a covariate.||1.53|-2.50|0.6354
91551156|NCT05321082|182985937|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2967|TWO_SIDED|95.0|0.65|1.14|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), baseline HRCT pattern, age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.14|0.65|0.2967
91551157|NCT05321082|182985937|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4815|TWO_SIDED|95.0|0.68|1.2|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), baseline HRCT pattern, age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.20|0.68|0.4815
91551158|NCT05321082|182985938|SUPERIORITY||Mean Difference (Net)|-0.88||||0.4748|TWO_SIDED|95.0|-3.3|1.54|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nerandomilast 9mg group and the Placebo group at Week 52.|Analysis was based on a Based on Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline L-PF Dyspnea score at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||1.54|-3.30|0.4748
91551159|NCT05321082|182985938|SUPERIORITY||Mean Difference (Net)|-1.27||||0.3042|TWO_SIDED|95.0|-3.69|1.15|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nerandomilast 18 mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline L-PF Dyspnea score at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||1.15|-3.69|0.3042
91551160|NCT05321082|182985939|SUPERIORITY||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|1.63||0.2506|TWO_SIDED|95.0|-5.08|1.33|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nerandomilast 9 mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline L-PF Cough score at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||1.33|-5.08|0.2506
91551161|NCT05321082|182985939|SUPERIORITY||Mean Difference (Net)|0.14||||0.9311|TWO_SIDED|95.0|-3.07|3.35|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nerandomilast 18 mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline L-PF Cough score at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||3.35|-3.07|0.9311
91551162|NCT05321082|182985940|SUPERIORITY||Mean Difference (Net)|0.05||||0.9668|TWO_SIDED|95.0|-2.46|2.57|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nerandomilast 9mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline L-PF Fatigue score at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||2.57|-2.46|0.9668
91551163|NCT05321082|182985940|SUPERIORITY||Mean Difference (Net)|0.94||||0.4644|TWO_SIDED|95.0|-1.58|3.46|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nerandomilast 18 mg group and the Placebo group at Week 52.|Analysis was based on a Mixed Model for Repeated Measures (MMRM), with fixed, categorical effects of treatment at each visit, baseline antifibrotic therapy at each visit, baseline HRCT pattern at each visit, the fixed continuous effects of baseline L-PF Fatigue score at each visit and unstructured covariance for repeated measures. Baseline antifibrotic therapy and HRCT pattern as entered in the CRF pages were used as covariates.||3.46|-1.58|0.4644
91551164|NCT03532282|182986020|SUPERIORITY||coefficient beta for change trajectory|-0.15||||0.001|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.001
91551165|NCT03532282|182986021|SUPERIORITY||coefficient beta for change trajectory|-0.01||||0.01|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.01
91551166|NCT03532282|182986022|SUPERIORITY||coefficient beta for change trajectory|-0.24||||0.0006|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.0006
91551167|NCT03532282|182986023|SUPERIORITY||coefficient beta for change trajectory|-0.04||||0.05|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.05
91551168|NCT02505984|182986039|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91551169|NCT02505984|182986039|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
91551170|NCT02505984|182986039|SUPERIORITY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
91551171|NCT02505984|182986039|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91551172|NCT02505984|182986040|SUPERIORITY||||||>|0.9|||||||Wilcoxon (Mann-Whitney)|||||||>0.9
91551173|NCT02505984|182986040|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91551174|NCT02505984|182986041|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
91551175|NCT02505984|182986041|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
91551176|NCT02505984|182986042|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
91551177|NCT02505984|182986042|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
91766732|NCT02719171|183422785|OTHER||Mean Difference (Final Values)|15.7|||<|0.001|TWO_SIDED|90.0|8.5|22.9|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||22.9|8.5|<0.001
91551178|NCT02505984|182986042|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91551179|NCT04176601|182986043|SUPERIORITY||Mean Difference (Net)|4.32|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.49|7.15||||||||7.15|1.49|
91551180|NCT04176601|182986044|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|1.26|8.15||||||||8.15|1.26|
91551181|NCT04176601|182986045|SUPERIORITY||Mean Difference (Net)|3.68|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|1.59|6.14||||||||6.14|1.59|
91551182|NCT05764525|182986067|SUPERIORITY||Difference of least squares mean|6.938||||0.0047|TWO_SIDED|95.0|2.145|11.731|||ANOVA|||||11.731|2.145|0.0047
91551183|NCT05093842|182986148|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91551184|NCT05093842|182986149|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91551185|NCT05093842|182986150|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91551186|NCT05093842|182986151|OTHER|Descriptive rates were calculated.|||||||||||||||||Descriptive statistics only|||
91551187|NCT05093842|182986152|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
91551188|NCT05093842|182986153|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
91551189|NCT05093842|182986154|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
91551190|NCT03910478|182986161|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.948||||0.892|TWO_SIDED|95.0|0.438|2.053|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician-recommended CMV monitoring tests in the study period by 1-year after HCT.||2.053|0.438|0.8920
91551191|NCT03910478|182986162|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.66||||0.3008|TWO_SIDED|95.0|0.301|1.45|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician -recommended CMV monitoring tests in the study period by 1-year after HCT.||1.450|0.301|0.3008
91551192|NCT06415292|182986184|SUPERIORITY||||||<|0.001||||||The P-value reported here is the calculated p-value. The p-value theshold for significance was p =0.05|t-test, 2 sided|||||||<0.001
91551193|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-178.789|||<|0.0001|TWO_SIDED|95.0|-204.899|-152.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-152.678|-204.899|<.0001
91551194|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-184.391|||<|0.0001|TWO_SIDED|95.0|-211.184|-157.598|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-157.598|-211.184|<.0001
91551195|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.1|||<|0.0001|TWO_SIDED|95.0|-200.964|-149.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-149.237|-200.964|<.0001
91551196|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-161.576|||<|0.0001|TWO_SIDED|95.0|-187.543|-135.609|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-135.609|-187.543|<.0001
91551197|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-172.983|||<|0.0001|TWO_SIDED|95.0|-192.08|-153.886|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-153.886|-192.080|<.0001
91551198|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-3.585||||0.7781|TWO_SIDED|95.0|-28.572|21.401|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||21.401|-28.572|0.7781
91551199|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-7.764||||0.5457|TWO_SIDED|95.0|-32.993|17.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||17.465|-32.993|0.5457
91551200|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.203|||<|0.0001|TWO_SIDED|95.0|-220.445|-129.961|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-129.961|-220.445|<.0001
91766733|NCT02719171|183422786|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|90.0|-4.0|2.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.5|-4.0|0.690
91766734|NCT02719171|183422786|OTHER||Mean Difference (Final Values)|-2.1||||0.26|TWO_SIDED|90.0|-5.3|1.0|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.0|-5.3|0.260
91766735|NCT02719171|183422787|OTHER||Mean Difference (Final Values)|-0.3||||0.791|TWO_SIDED|90.0|-2.1|1.5|||Cochran-Mantel-Haenszel|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-2.1|0.791
91766736|NCT02719171|183422787|OTHER||Mean Difference (Final Values)|-1.1||||0.32|TWO_SIDED|90.0|-2.8|0.7|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.7|-2.8|0.320
91551201|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-176.627|||<|0.0001|TWO_SIDED|95.0|-222.672|-130.582|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-130.582|-222.672|<.0001
91551202|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-171.515|||<|0.0001|TWO_SIDED|95.0|-216.626|-126.404|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-126.404|-216.626|<.0001
91551203|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.812|||<|0.0001|TWO_SIDED|95.0|-199.27|-108.354|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-108.354|-199.270|<.0001
91551204|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-165.22|||<|0.0001|TWO_SIDED|95.0|-195.898|-134.541|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-134.541|-195.898|<.0001
91551205|NCT04800211|182986274|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.815||||0.2188|TWO_SIDED|95.0|-59.223|13.593|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||13.593|-59.223|0.2188
91551206|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-248.311|||<|0.0001|TWO_SIDED|95.0|-286.423|-210.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-210.199|-286.423|<.0001
91766737|NCT02719171|183422788|OTHER||mixed model repeated measures model|-0.082||||0.341|TWO_SIDED|90.0|-0.225|0.06|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.060|-0.225|0.341
91766738|NCT02719171|183422788|OTHER||Mean Difference (Final Values)|-0.114||||0.181|TWO_SIDED|90.0|-0.254|0.027|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.027|-0.254|0.181
91551207|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-247.572|||<|0.0001|TWO_SIDED|95.0|-280.904|-214.241|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-214.241|-280.904|<.0001
91551208|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-245.868|||<|0.0001|TWO_SIDED|95.0|-284.945|-206.791|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.791|-284.945|<.0001
91551209|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-234.942|||<|0.0001|TWO_SIDED|95.0|-271.603|-198.282|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-198.282|-271.603|<.0001
91551210|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-244.049|||<|0.0001|TWO_SIDED|95.0|-275.269|-212.829|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-212.829|-275.269|<.0001
91551211|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-221.385|||<|0.0001|TWO_SIDED|95.0|-258.371|-184.398|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-184.398|-258.371|<.0001
91551212|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-233.626|||<|0.0001|TWO_SIDED|95.0|-261.113|-206.14|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.140|-261.113|<.0001
91551213|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|26.266||||0.1672|TWO_SIDED|95.0|-11.13|63.661|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||63.661|-11.130|0.1672
91551214|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.051||||0.014|TWO_SIDED|95.0|-71.881|-8.221|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-8.221|-71.881|0.0140
91551215|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.635||||0.0288|TWO_SIDED|95.0|-80.785|-4.484|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-4.484|-80.785|0.0288
91551216|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-274.577|||<|0.0001|TWO_SIDED|95.0|-345.428|-203.726|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-203.726|-345.428|<.0001
91551217|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-207.521|||<|0.0001|TWO_SIDED|95.0|-269.198|-145.844|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-145.844|-269.198|<.0001
91766739|NCT02719171|183422789|OTHER||Mean Difference (Final Values)|1.7||||0.174|TWO_SIDED|90.0|-0.36|3.77|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.77|-0.36|0.174
91766740|NCT02719171|183422789|OTHER||Mean Difference (Final Values)|1.35||||0.284|TWO_SIDED|90.0|-0.73|3.44|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.44|-0.73|0.284
91766741|NCT02719171|183422790|OTHER||Mean Difference (Final Values)|0.59||||0.718|TWO_SIDED|90.0|-2.12|3.3|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.30|-2.12|0.718
91551218|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.233|||<|0.0001|TWO_SIDED|95.0|-275.683|-130.784|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-130.784|-275.683|<.0001
91551219|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-261.208|||<|0.0001|TWO_SIDED|95.0|-330.647|-191.769|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-191.769|-330.647|<.0001
91551220|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.998|||<|0.0001|TWO_SIDED|95.0|-263.396|-144.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.599|-263.396|<.0001
91551221|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-178.75|||<|0.0001|TWO_SIDED|95.0|-249.092|-108.408|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-108.408|-249.092|<.0001
91766742|NCT02719171|183422790|OTHER||Mean Difference (Final Values)|2.06||||0.204|TWO_SIDED|90.0|-0.61|4.74|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||4.74|-0.61|0.204
91766743|NCT02719171|183422791|OTHER||Mean Difference (Final Values)|1.2||||0.243|TWO_SIDED|90.0|-0.5|2.8|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.8|-0.5|0.243
91766744|NCT02719171|183422791|OTHER||Mean Difference (Final Values)|0.1||||0.906|TWO_SIDED|90.0|-1.0|1.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.1|-1.0|0.906
91766745|NCT02719171|183422792|OTHER||Mean Difference (Final Values)|-0.7||||0.325|TWO_SIDED|90.0|-1.8|0.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.5|-1.8|0.325
91766746|NCT02719171|183422792|OTHER||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED|90.0|-2.1|0.2|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.2|-2.1|0.160
91766747|NCT02719171|183422793|OTHER||Mean Difference (Final Values)|-1.2||||0.453|TWO_SIDED|90.0|-4.0|1.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-4.0|0.453
91551222|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-190.992|||<|0.0001|TWO_SIDED|95.0|-237.134|-144.85|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.850|-237.134|<.0001
91551223|NCT04800211|182986275|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-24.483||||0.359|TWO_SIDED|95.0|-77.096|28.13|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||28.130|-77.096|0.3590
91551224|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.287|||<|0.0001|TWO_SIDED|95.0|-2.582|-1.992|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-1.992|-2.582|<.0001
91551225|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.415|||<|0.0001|TWO_SIDED|95.0|-2.722|-2.107|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.107|-2.722|<.0001
91551226|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.382|||<|0.0001|TWO_SIDED|95.0|-2.673|-2.09|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-2.090|-2.673|<.0001
91766748|NCT02719171|183422793|OTHER||Mean Difference (Final Values)|-2.8||||0.111|TWO_SIDED|90.0|-5.7|0.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.1|-5.7|0.111
91766749|NCT02719171|183422794|OTHER||Mean Difference (Final Values)|53.5|||<|0.001|TWO_SIDED|90.0|35.9|71.1|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||71.1|35.9|<0.001
91766750|NCT02719171|183422794|OTHER||Mean Difference (Final Values)|48.8|||<|0.001|TWO_SIDED|90.0|33.1|64.5|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||64.5|33.1|<0.001
91766751|NCT05298202|183422804|SUPERIORITY|time x treatment ANOVA||||||0.284||||||difference between treatment and control|ANOVA|||||||0.284
91766752|NCT05298202|183422805|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||.177
91766753|NCT05298202|183422806|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||.122
91766754|NCT05298202|183422807|SUPERIORITY|||||||0.038|||||||ANOVA|time x treatment anova||||||.038
91766755|NCT05298202|183422808|SUPERIORITY|||||||0.976|||||||ANOVA|||||||.976
91766756|NCT05298202|183422809|SUPERIORITY|||||||0.747|||||||ANOVA|||||||.747
91766757|NCT02796677|183422825|SUPERIORITY||LS mean difference|0.084|||<|0.0001|TWO_SIDED|95.0|0.051|0.117|||Mixed model for repeated measures|||||0.117|0.051|<0.0001
91766758|NCT02796677|183422826|SUPERIORITY||LS mean difference|0.055||||0.0009|TWO_SIDED|95.0|0.023|0.088|||Mixed model for repeated measures|||||0.088|0.023|0.0009
91551227|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.486|||<|0.0001|TWO_SIDED|95.0|-2.782|-2.19|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.190|-2.782|<.0001
91551228|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.668|-2.233|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.233|-2.668|<.0001
91551229|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.466||||0.0012|TWO_SIDED|95.0|0.185|0.747|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.747|0.185|0.0012
91551230|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.099||||0.4957|TWO_SIDED|95.0|-0.187|0.386|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.386|-0.187|0.4957
91551231|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.753|||<|0.0001|TWO_SIDED|95.0|-3.266|-2.239|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.239|-3.266|<.0001
91766759|NCT02796677|183422827|NON_INFERIORITY|Non-inferiority was established by showing that the lower bound of the two-sided 95% confidence interval for change from baseline in morning pre-dose (trough) FEV1 at week 24 when compared AB 400 μg versus TIO 18 μg was higher than -50 mL (non-inferiority limit).|LS mean difference|0.007||||0.6377|TWO_SIDED|95.0|-0.021|0.035|||Mixed model for repeated measures|||||0.035|-0.021|0.6377
91766760|NCT02796677|183422828|SUPERIORITY||LS mean difference|0.075|||<|0.0001|TWO_SIDED|95.0|0.043|0.107|||Mixed model for repeated measures|||||0.107|0.043|<0.0001
91766761|NCT02796677|183422828|SUPERIORITY||LS mean difference|0.087|||<|0.0001|TWO_SIDED|95.0|0.052|0.122|||Mixed model for repeated measures|||||0.122|0.052|<0.0001
91766762|NCT02796677|183422829|SUPERIORITY||Odds ratio|0.96||||0.8714|TWO_SIDED|95.0|0.61|1.51|||Logistic random-effect model|||||1.51|0.61|0.8714
91766763|NCT02796677|183422829|SUPERIORITY||Odds ratio|0.97||||0.8873|TWO_SIDED|95.0|0.59|1.58|||Logistic random-effect model|||||1.58|0.59|0.8873
91766764|NCT03270943|183422871|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
91766765|NCT03270943|183422872|OTHER|within group|Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-6.06|3.84|||||Difference between score at 8 weeks and score at baseline.|||3.84|-6.06|
91766766|NCT03270943|183422872|OTHER|within group|Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-8.7|-0.22|||||Difference between score at 8 weeks and score at baseline.|||-0.22|-8.70|
91766767|NCT03270943|183422873|OTHER|within group change|Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.72|0.2|||||Difference between score at 8 weeks and score at baseline.|||0.2|-2.72|
91766768|NCT03270943|183422873|OTHER|within group change|Mean Difference (Net)|-1.72|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-3.6|0.16|||||Difference between score at 8 weeks and score at baseline.|||0.16|-3.60|
91766769|NCT03270943|183422874|OTHER|Within group change|Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.15|0.61|||||Difference between score at 8 weeks and score at baseline.|||0.61|-0.15|
91766770|NCT03270943|183422874|OTHER|within group change|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.07|0.63|||||Difference between score at 8 weeks and score at baseline.|||0.63|0.07|
91766771|NCT01116401|183422886|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||||||0.007
91551232|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.514|||<|0.0001|TWO_SIDED|95.0|-3.043|-1.986|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-1.986|-3.043|<.0001
91551233|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.848|||<|0.0001|TWO_SIDED|95.0|-3.359|-2.336|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.336|-3.359|<.0001
91551234|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.105|-2.066|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.066|-3.105|<.0001
91766772|NCT01116401|183422887|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||||||<0.01
91766773|NCT00754377|183422891|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
91766774|NCT00754377|183422892|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
91766775|NCT04057807|183422907|SUPERIORITY|||||||0.14|||||||unpaired t-tests (continuous variables)|||||||0.14
91766776|NCT04057807|183422908|SUPERIORITY|||||||0.82|||||||univariate linear regression analysis|two-tailed P value was obtained from a univariate linear regression analysis||||||0.82
91766777|NCT03985761|183422914|SUPERIORITY|||||||0.182|||||||ANOVA|||||||.182
91766778|NCT03985761|183422915|SUPERIORITY|||||||0.296|||||||ANOVA|||||||.296
91766779|NCT03985761|183422916|SUPERIORITY|||||||0.483|||||||ANOVA|||||||.483
91766780|NCT03985761|183422917|SUPERIORITY|||||||0.995|||||||ANOVA|||||||.995
91766781|NCT03985761|183422918|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.220
91766782|NCT03985761|183422919|SUPERIORITY|||||||0.538|||||||ANOVA|||||||.538
91766783|NCT03985761|183422922|SUPERIORITY|||||||0.121|||||||ANOVA|||||||.121
91551235|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.55|||<|0.0001|TWO_SIDED|95.0|-2.901|-2.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.199|-2.901|<.0001
91551236|NCT04800211|182986276|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.071||||0.7372|TWO_SIDED|95.0|-0.346|0.489|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.489|-0.346|0.7372
91766784|NCT00721396|183422982|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence interval of the difference in the percentage of subjects with hSBA titer ≥1:5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 44/76-SL strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
91766785|NCT00721396|183422982|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference %(B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 5/99 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
91766786|NCT00721396|183422982|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|-8.0|||||TWO_SIDED|95.0|-12.0|-4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against NZ98/254 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||-4|-12|
91766787|NCT00721396|183422983|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for diphtheria (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Diphtheria antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-1|
91551237|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.106|||<|0.0001|TWO_SIDED|95.0|-3.502|-2.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.710|-3.502|<.0001
91551238|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.824|||<|0.0001|TWO_SIDED|95.0|-3.235|-2.414|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.414|-3.235|<.0001
91766788|NCT00721396|183422983|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for tetanus toxoid (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Non-inferiority of immune response to Tetanus antigens when routine vaccines are administered concomitantly with rMen+OMV NZ vaccine.||2|-1|
91551239|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.228|||<|0.0001|TWO_SIDED|95.0|-3.553|-2.904|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.904|-3.553|<.0001
91551240|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.839|||<|0.0001|TWO_SIDED|95.0|-3.221|-2.457|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.457|-3.221|<.0001
91766789|NCT00721396|183422988|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-5.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen FHA when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||4|-5|
91766790|NCT00721396|183422988|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen pertactin antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-7|
91766791|NCT00721396|183422988|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen PT when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-4|
91551241|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.449|||<|0.0001|TWO_SIDED|95.0|-2.828|-2.07|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.070|-2.828|<.0001
91551242|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.023|||<|0.0001|TWO_SIDED|95.0|-3.328|-2.718|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.718|-3.328|<.0001
91551243|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.126|||<|0.0001|TWO_SIDED|95.0|-3.354|-2.897|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.897|-3.354|<.0001
91551244|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.908|||<|0.0001|TWO_SIDED|95.0|0.518|1.298|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.298|0.518|<.0001
91551245|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|1.291|||<|0.0001|TWO_SIDED|95.0|0.902|1.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.679|0.902|<.0001
91766792|NCT00430716|183423001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|24.15||||0.011|ONE_SIDED|97.5|3.37||||ANOVA|||An analysis of variance (ANOVA) model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||3.37|0.011
91766793|NCT00430716|183423001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17||||0.545|ONE_SIDED|97.5|-21.48||||ANOVA|||ANOVA model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||-21.48|0.545
91551246|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.174||||0.2772|TWO_SIDED|95.0|-0.142|0.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.490|-0.142|0.2772
91551247|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.014|||<|0.0001|TWO_SIDED|95.0|-4.75|-3.278|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.278|-4.750|<.0001
91551248|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.115|||<|0.0001|TWO_SIDED|95.0|-4.865|-3.365|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.365|-4.865|<.0001
91551249|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.403|||<|0.0001|TWO_SIDED|95.0|-4.005|-2.801|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.801|-4.005|<.0001
91551250|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.747|||<|0.0001|TWO_SIDED|95.0|-4.473|-3.02|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.020|-4.473|<.0001
91766794|NCT00430716|183423002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.51||||0.278|TWO_SIDED|95.0|-7.07|2.05|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used Analysis of Covariance (ANCOVA), with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||2.05|-7.07|0.278
91766795|NCT00430716|183423002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||0.846|TWO_SIDED|95.0|-4.98|4.09|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used ANCOVA, with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||4.09|-4.98|0.846
91551251|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-4.461|-3.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.018|-4.461|<.0001
91551252|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.197|||<|0.0001|TWO_SIDED|95.0|-3.784|-2.61|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.610|-3.784|<.0001
91551253|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.678|-2.921|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.921|-3.678|<.0001
91551254|NCT04800211|182986277|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-0.206||||0.348|TWO_SIDED|95.0|-0.638|0.226|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.226|-0.638|0.3480
91551255|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.716|||<|0.0001|TWO_SIDED|95.0|-0.951|-0.481|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)||-0.481|-0.951|<0.0001
91551256|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.686|||<|0.0001|TWO_SIDED|95.0|-0.966|-0.406|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)||-0.406|-0.966|<0.0001
91551257|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.521|||<|0.0001|TWO_SIDED|95.0|-0.755|-0.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)||-0.288|-0.755|<.0001
91551258|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.342||||0.0131|TWO_SIDED|95.0|-0.612|-0.072|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.072|-0.612|0.0131
91551259|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.514|||<|0.0001|TWO_SIDED|95.0|-0.712|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.316|-0.712|<.0001
91551260|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.231||||0.0435|TWO_SIDED|95.0|-0.455|-0.007|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)||-0.007|-0.455|0.0435
91551261|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|0.111||||0.4012|TWO_SIDED|95.0|-0.149|0.371|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)||0.371|-0.149|0.4012
91551262|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.485||||0.0133|TWO_SIDED|95.0|-0.895|-0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)||-0.074|-0.895|0.0133
91551263|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.797||||0.0002|TWO_SIDED|95.0|-1.277|-0.317|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)||-0.317|-1.277|0.0002
91551264|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.29||||0.2641|TWO_SIDED|95.0|-0.699|0.119|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)||0.119|-0.699|0.2641
91766796|NCT00430716|183423004|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.448|TWO_SIDED|95.0|0.5|4.78|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||4.78|0.50|0.448
91766797|NCT00430716|183423004|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.897|TWO_SIDED|95.0|0.35|3.32|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||3.32|0.35|0.897
91551265|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.453||||0.0639|TWO_SIDED|95.0|-0.924|0.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)||0.018|-0.924|0.0639
91551266|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.625||||0.0001|TWO_SIDED|95.0|-0.945|-0.305|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)||-0.305|-0.945|0.0001
91551267|NCT04800211|182986278|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)|Mean Difference (Net)|-0.344||||0.0776|TWO_SIDED|95.0|-0.725|0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)||0.038|-0.725|0.0776
91551268|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.621||||0.0055|TWO_SIDED|95.0|-1.055|-0.186|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.186|-1.055|0.0055
91551269|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.778||||0.0011|TWO_SIDED|95.0|-1.24|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.316|-1.240|0.0011
91766798|NCT00430716|183423005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-104.8||||0.005|TWO_SIDED|95.0|-177.44|-32.16|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-32.16|-177.44|0.005
91766799|NCT00430716|183423005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.0||||0.496|TWO_SIDED|95.0|-97.5|47.5|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||47.50|-97.50|0.496
91766800|NCT00430716|183423006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-462.12||||0.009|TWO_SIDED|95.0|-807.53|-116.71|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-116.71|-807.53|0.009
91766801|NCT00430716|183423006|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-141.45||||0.414|TWO_SIDED|95.0|-483.48|200.58|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||200.58|-483.48|0.414
91551270|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.54|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.540|-1.260|<.0001
91551271|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.52||||0.015|TWO_SIDED|95.0|-0.938|-0.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.103|-0.938|0.0150
91551272|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.349||||0.1048|TWO_SIDED|95.0|-0.771|0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.074|-0.771|0.1048
91766802|NCT00430716|183423007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.89|TWO_SIDED|95.0|-0.17|0.15|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||0.15|-0.17|0.890
91766803|NCT00430716|183423007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||0.04|-0.29|0.124
91766804|NCT00430716|183423008|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.382|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||0.00|-1.00|0.382
91766805|NCT00430716|183423008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.141|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||1.00|0.00|0.141
91766806|NCT02927392|183423015|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91766807|NCT00064792|183423043|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The primary outcome variable will be the serum cholesterol/total sterol ratio.||||0.002
91766808|NCT00064792|183423044|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
91766809|NCT00291486|183423059|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|||Comparison of CL between initial infusion and therapy infusion||||0.144
91766810|NCT00291486|183423060|SUPERIORITY|||||||0.361|||||||ANOVA|||||||0.361
91766811|NCT01025830|183423109|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.87|1.38||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.38|0.87|
91551273|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.846|||<|0.0001|TWO_SIDED|95.0|-1.185|-0.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.507|-1.185|<.0001
91551274|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.873|||<|0.0001|TWO_SIDED|95.0|-1.127|-0.619|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.619|-1.127|<.0001
91551275|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.247||||0.2525|TWO_SIDED|95.0|-0.178|0.671|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.671|-0.178|0.2525
91551276|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.098||||0.6503|TWO_SIDED|95.0|-0.33|0.527|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.527|-0.330|0.6503
91551277|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.239||||0.1759|TWO_SIDED|95.0|-0.109|0.588|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.588|-0.109|0.1759
91551278|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.867||||0.0293|TWO_SIDED|95.0|-1.674|-0.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.060|-1.674|0.0293
91551279|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.876||||0.0362|TWO_SIDED|95.0|-1.714|-0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.038|-1.714|0.0362
91551280|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.139|||<|0.0001|TWO_SIDED|95.0|-1.809|-0.469|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.469|-1.809|<.0001
91551281|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.767||||0.0621|TWO_SIDED|95.0|-1.559|0.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.025|-1.559|0.0621
91551282|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.447||||0.5259|TWO_SIDED|95.0|-1.246|0.352|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.352|-1.246|0.5259
91551283|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.736|-0.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.435|-1.736|<.0001
91551284|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.112|||<|0.0001|TWO_SIDED|95.0|-1.532|-0.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.693|-1.532|<.0001
91551285|NCT04800211|182986279|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.054||||0.8248|TWO_SIDED|95.0|-0.535|0.427|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.427|-0.535|0.8248
91766812|NCT01025830|183423109|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.31||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.31|0.95|
91766813|NCT01025830|183423109|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|0.8||||||90.0|0.65|0.99||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||0.99|0.65|
91766814|NCT01025830|183423110|NON_INFERIORITY_OR_EQUIVALENCE|same as for AUC|Geometric Mean Ratio|1.3||||||90.0|0.99|1.71||same as for AUC|Non-compartmental model|same as for AUC|same as AUC|Same as for AUC||1.71|0.99|
91766815|NCT01025830|183423110|NON_INFERIORITY_OR_EQUIVALENCE|same for all three drugs.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.23||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||1.23|0.95|
91551286|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.821||||0.0002|TWO_SIDED|95.0|1.369|4.273|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||4.273|1.369|0.0002
91551287|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.468|||<|0.0001|TWO_SIDED|95.0|1.85|5.086|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||5.086|1.850|<.0001
91551288|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.245||||0.0022|TWO_SIDED|95.0|0.812|3.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||3.679|0.812|0.0022
91766816|NCT01025830|183423110|NON_INFERIORITY_OR_EQUIVALENCE|Same for all three drugs.|Geometric Mean Ratio|0.8||||||90.0|0.63|0.98||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||0.98|0.63|
91766817|NCT04177212|183423118|OTHER||||||<|0.0001||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50 percent (%).|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||< 0.0001
91766818|NCT04177212|183423119|OTHER|||||||0.0003||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50%.|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||0.0003
91766819|NCT01279681|183423133|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.93|TWO_SIDED|95.0|0.49|2.17|||Regression, Cox|||||2.17|0.49|0.93
91766820|NCT02831764|183423153|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|-0.7|||||TWO_SIDED|95.0|-4.3|2.9|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 copies per milliliter) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter \[cells/mm\^3\]).|||2.9|-4.3|
91766821|NCT02831764|183423154|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 24 was greater than -10%.|Adjusted difference in proportion|0.1|||||TWO_SIDED|95.0|-3.4|3.6|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||3.6|-3.4|
91766822|NCT02831764|183423155|OTHER||Adjusted difference in proportion|-1.8|||||TWO_SIDED|95.0|-6.4|2.7|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.7|-6.4|
91766823|NCT02831764|183423156|OTHER||Adjusted difference in proportion|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||5.3|-5.3|
91766824|NCT02831764|183423157|OTHER||Hazard Ratio (HR)|1.02||||0.797|TWO_SIDED|95.0|0.88|1.19||The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalised Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.19|0.88|0.797
91766825|NCT02831764|183423161|OTHER||Mean Difference (Net)|25.6||||0.043|TWO_SIDED|95.0|0.8|50.4|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||50.4|0.8|0.043
91551289|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.329|||<|0.0001|TWO_SIDED|95.0|1.768|4.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.891|1.768|<.0001
91766826|NCT02831764|183423161|OTHER||Mean Difference (Net)|8.5||||0.523|TWO_SIDED|95.0|-17.7|34.8|||MMRM||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||34.8|-17.7|0.523
91766827|NCT02831764|183423162|OTHER||Mean Difference (Net)|7.4||||0.635|TWO_SIDED|95.0|-23.2|38.0|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||38.0|-23.2|0.635
91766828|NCT02831764|183423163|OTHER||Mean Difference (Net)|5.1||||0.777|TWO_SIDED|95.0|-29.9|40.0|||MMRM||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||40.0|-29.9|0.777
91766829|NCT02831764|183423174|OTHER||Mean Difference (Net)|-0.03|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||MMRM||Week 24. Serum Cystatin C.|||-0.02|-0.05|<0.001
91766830|NCT02831764|183423174|OTHER||Mean Difference (Net)|-0.02||||0.022|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 48. Serum Cystatin C.|||0.00|-0.03|0.022
91766831|NCT02831764|183423174|OTHER||Mean Difference (Net)|-0.2||||0.797|TWO_SIDED|95.0|-1.4|1.1|||MMRM||Week 24. Serum RBP|||1.1|-1.4|0.797
91766832|NCT02831764|183423174|OTHER||Mean Difference (Net)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||MMRM||Week 48. Serum RBP|||1.9|-0.5|0.258
91766833|NCT02831764|183423175|OTHER||Mean Difference (Net)|-0.02||||0.034|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 96. Serum Cystatin C.|||0.00|-0.03|0.034
91766834|NCT02831764|183423176|OTHER||Mean Difference (Net)|-0.02||||0.006|TWO_SIDED|95.0|-0.04|-0.01|||MMRM||Week 144. Serum Cystatin C.|||-0.01|-0.04|0.006
91766835|NCT02831764|183423179|OTHER||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|5.4|||MMRM||Week 24. GFR Cystatin C adjusted.|||5.4|1.8|<0.001
91766836|NCT02831764|183423179|OTHER||Mean Difference (Net)|1.7||||0.056|TWO_SIDED|95.0|0.0|3.5|||MMRM||Week 48. GFR Cystatin C adjusted.|||3.5|0.0|0.056
91766837|NCT02831764|183423179|OTHER||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|1.7|5.2|||MMRM||Week 24. GFR creatinine adjusted.|||5.2|1.7|<0.001
91766838|NCT02831764|183423179|OTHER||Mean Difference (Net)|3.3|||<|0.001|TWO_SIDED|95.0|1.6|5.0|||MMRM||Week 48. GFR creatinine adjusted.|||5.0|1.6|<0.001
91766839|NCT02831764|183423182|OTHER||Mean Difference (Net)|-3.02|||<|0.001|TWO_SIDED|95.0|-4.49|-1.55|||MMRM||Week 24. Serum or Plasma Creatinine|||-1.55|-4.49|<0.001
91766840|NCT02831764|183423182|OTHER||Mean Difference (Net)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.59|-1.65|||MMRM||Week 48. Serum or Plasma creatinine|||-1.65|-4.59|<0.001
91766841|NCT02831764|183423183|OTHER||Mean Difference (Net)|-3.04|||<|0.001|TWO_SIDED|95.0|-4.56|-1.53|||MMRM||Week 96. Serum or Plasma creatinine|||-1.53|-4.56|<0.001
91766842|NCT02831764|183423184|OTHER||Mean Difference (Net)|-2.86|||<|0.001|TWO_SIDED|95.0|-4.52|-1.19|||MMRM||Week 144. Serum or Plasma creatinine|||-1.19|-4.52|<0.001
91766843|NCT02831764|183423185|OTHER||Ratio of geometric means|0.917|||<|0.001|TWO_SIDED|95.0|0.893|0.941|||MMRM||Week 24. Serum B2M.|||0.941|0.893|<0.001
91766844|NCT02831764|183423185|OTHER||Ratio of geometric means|0.914|||<|0.001|TWO_SIDED|95.0|0.89|0.939|||MMRM||Week 48. Serum B2M.|||0.939|0.890|<0.001
91766845|NCT02831764|183423185|OTHER||Ratio of geometric means|0.748||||0.002|TWO_SIDED|95.0|0.621|0.901|||MMRM||Week 24. Urine B2M.|||0.901|0.621|0.002
91766846|NCT02831764|183423185|OTHER||Ratio of geometric means|0.693||||0.005|TWO_SIDED|95.0|0.538|0.892|||MMRM||Week 48. Urine B2M.|||0.892|0.538|0.005
91766847|NCT02831764|183423185|OTHER||Ratio of geometric means|0.889||||0.036|TWO_SIDED|95.0|0.796|0.992|||MMRM||Week 24. Urine Albumin/Creatinine.|||0.992|0.796|0.036
91766848|NCT02831764|183423185|OTHER||Ratio of geometric means|0.938||||0.308|TWO_SIDED|95.0|0.83|1.061|||MMRM||Week 48. Urine Albumin/Creatinine.|||1.061|0.830|0.308
91766849|NCT02831764|183423185|OTHER||Ratio of geometric means|0.781||||0.007|TWO_SIDED|95.0|0.654|0.934|||MMRM||Week 24. Urine B2M/Urine Creatinine.|||0.934|0.654|0.007
91766850|NCT02831764|183423185|OTHER||Ratio of geometric means|0.742||||0.012|TWO_SIDED|95.0|0.588|0.935|||MMRM||Week 48. Urine B2M/Urine Creatinine.|||0.935|0.588|0.012
91766851|NCT02831764|183423185|OTHER||Ratio of geometric means|0.979||||0.728|TWO_SIDED|95.0|0.868|1.104|||MMRM||Week 24. Urine Phosphate.|||1.104|0.868|0.728
91766852|NCT02831764|183423185|OTHER||Ratio of geometric means|1.062||||0.311|TWO_SIDED|95.0|0.945|1.194|||MMRM||Week 48. Urine Phosphate.|||1.194|0.945|0.311
91766853|NCT02831764|183423185|OTHER||Ratio of geometric means|0.826|||<|0.001|TWO_SIDED|95.0|0.769|0.887|||MMRM||Week 24. Urine Protein/Creatinine.|||0.887|0.769|<0.001
91766854|NCT02831764|183423185|OTHER||Ratio of geometric means|0.86|||<|0.001|TWO_SIDED|95.0|0.795|0.93|||MMRM||Week 48. Urine Protein/Creatinine.|||0.930|0.795|<0.001
91766855|NCT02831764|183423185|OTHER||Ratio of geometric means|0.796||||0.003|TWO_SIDED|95.0|0.683|0.927|||MMRM||Week 24. Urine RBP 4|||0.927|0.683|0.003
91551290|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.399|||<|0.0001|TWO_SIDED|95.0|2.252|4.545|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.545|2.252|<.0001
91551291|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.25||||0.0761|TWO_SIDED|95.0|-0.132|2.633|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||2.633|-0.132|0.0761
91551292|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.778||||0.0211|TWO_SIDED|95.0|0.269|3.286|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||3.286|0.269|0.0211
91551293|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.57||||0.3841|TWO_SIDED|95.0|-0.951|4.092|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||4.092|-0.951|0.3841
91551294|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.69||||0.3934|TWO_SIDED|95.0|-1.084|4.464|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.464|-1.084|0.3934
91551295|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.995||||0.7782|TWO_SIDED|95.0|-1.505|3.494|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||3.494|-1.505|0.7782
91766856|NCT02831764|183423185|OTHER||Ratio of geometric means|0.903||||0.2|TWO_SIDED|95.0|0.773|1.056|||MMRM||Week 48. Urine RBP 4|||1.056|0.773|0.200
91766857|NCT02831764|183423185|OTHER||Ratio of geometric means|0.826||||0.003|TWO_SIDED|95.0|0.728|0.936|||MMRM||Week 24. Urine RBP 4/Urine Creatinine|||0.936|0.728|0.003
91766858|NCT02831764|183423185|OTHER||Ratio of geometric means|0.888||||0.052|TWO_SIDED|95.0|0.787|1.001|||MMRM||Week 48. Urine RBP 4/Urine Creatinine|||1.001|0.787|0.052
91766859|NCT02831764|183423186|OTHER||Ratio of geometric means|0.942||||0.338|TWO_SIDED|95.0|0.833|1.065|||MMRM||Week 96. Urine Albumin/Creatinine.|||1.065|0.833|0.338
91766860|NCT02831764|183423186|OTHER||Ratio of geometric means|0.671|||<|0.001|TWO_SIDED|95.0|0.545|0.826|||MMRM||Week 96. Urine B2M/Urine Creatinine.|||0.826|0.545|<0.001
91766861|NCT02831764|183423186|OTHER||Ratio of geometric means|1.082||||0.174|TWO_SIDED|95.0|0.966|1.213|||MMRM||Week 96. Urine Phosphate.|||1.213|0.966|0.174
91766862|NCT02831764|183423186|OTHER||Ratio of geometric means|0.873|||<|0.001|TWO_SIDED|95.0|0.806|0.946|||MMRM||Week 96. Urine Protein/Creatinine.|||0.946|0.806|<0.001
91551296|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.552||||0.4576|TWO_SIDED|95.0|-1.171|4.274|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.274|-1.171|0.4576
91551297|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.621||||0.0849|TWO_SIDED|95.0|-0.224|3.466|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.466|-0.224|0.0849
91551298|NCT04800211|182986280|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.139||||0.9016|TWO_SIDED|95.0|-2.064|2.341|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||2.341|-2.064|0.9016
91766863|NCT02831764|183423186|OTHER||Ratio of geometric means|0.8|||<|0.001|TWO_SIDED|95.0|0.716|0.894|||MMRM||Week 96. Urine RBP 4/Urine Creatinine|||0.894|0.716|<0.001
91766864|NCT02831764|183423187|OTHER||Ratio of geometric means|0.971||||0.658|TWO_SIDED|95.0|0.852|1.107|||MMRM||Week 144. Urine Albumin/Creatinine.|||1.107|0.852|0.658
91766865|NCT02831764|183423187|OTHER||Ratio of geometric means|0.584|||<|0.001|TWO_SIDED|95.0|0.483|0.706|||MMRM||Week 144. Urine B2M/Urine Creatinine.|||0.706|0.483|<0.001
91766866|NCT02831764|183423187|OTHER||Ratio of geometric means|1.0||||0.993|TWO_SIDED|95.0|0.892|1.12|||MMRM||Week 144. Urine Phosphate.|||1.120|0.892|0.993
91766867|NCT02831764|183423187|OTHER||Ratio of geometric means|0.847|||<|0.001|TWO_SIDED|95.0|0.785|0.913|||MMRM||Week 144. Urine Protein/Creatinine.|||0.913|0.785|<0.001
91766868|NCT02831764|183423187|OTHER||Ratio of geometric means|0.739|||<|0.001|TWO_SIDED|95.0|0.667|0.819|||MMRM||Week 144. Urine RBP 4/Urine Creatinine|||0.819|0.667|<0.001
91766869|NCT02831764|183423188|OTHER||Mean Difference (Net)|-2.66|||<|0.001|TWO_SIDED|95.0|-3.25|-2.08|||MMRM||Week 24, Bone ALP|||-2.08|-3.25|<0.001
91766870|NCT02831764|183423188|OTHER||Mean Difference (Net)|-3.09|||<|0.001|TWO_SIDED|95.0|-3.75|-2.44|||MMRM||Week 48, Bone ALP|||-2.44|-3.75|<0.001
91766871|NCT02831764|183423188|OTHER||Mean Difference (Net)|-4.67|||<|0.001|TWO_SIDED|95.0|-5.63|-3.71|||MMRM||Week 28, Serum Osteocalcin|||-3.71|-5.63|<0.001
91766872|NCT02831764|183423188|OTHER||Mean Difference (Net)|-5.9|||<|0.001|TWO_SIDED|95.0|-6.89|-4.91|||MMRM||Week 48, Serum Osteocalcin|||-4.91|-6.89|<0.001
91766873|NCT02831764|183423188|OTHER||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-16.4|-10.6|||MMRM||Week 24, Serum PINP|||-10.6|-16.4|<0.001
91766874|NCT02831764|183423188|OTHER||Mean Difference (Net)|-12.8|||<|0.001|TWO_SIDED|95.0|-15.4|-10.2|||MMRM||Week 48, Serum PINP|||-10.2|-15.4|<0.001
91766875|NCT02831764|183423188|OTHER||Mean Difference (Net)|-0.127|||<|0.001|TWO_SIDED|95.0|-0.164|-0.09|||MMRM||Week 24, CTX-1|||-0.0900|-0.1640|<0.001
91766876|NCT02831764|183423188|OTHER||Mean Difference (Net)|-0.2043|||<|0.001|TWO_SIDED|95.0|-0.2532|-0.1554|||MMRM||Week 48, CTX-1|||-0.1554|-0.2532|<0.001
91766877|NCT02831764|183423189|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.72|-1.54|||MMRM||Week 96, Bone ALP|||-1.54|-2.72|<0.001
91551299|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.587||||0.0004|TWO_SIDED|95.0|2.511|8.662|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.662|2.511|0.0004
91551300|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.556||||0.1141|TWO_SIDED|95.0|-0.62|5.732|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.732|-0.620|0.1141
91551301|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.536||||0.0007|TWO_SIDED|95.0|2.367|8.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.705|2.367|0.0007
91766878|NCT02831764|183423189|OTHER||Mean Difference (Net)|-3.77|||<|0.001|TWO_SIDED|95.0|-4.69|-2.85|||MMRM||Week 96, Serum Osteocalcin|||-2.85|-4.69|<0.001
91766879|NCT02831764|183423189|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-16.8|-8.3|||MMRM||Week 96, Serum PINP|||-8.3|-16.8|<0.001
91766880|NCT02831764|183423189|OTHER||Mean Difference (Net)|-0.1183|||<|0.001|TWO_SIDED|95.0|-0.1529|-0.0838|||MMRM||Week 96, CTX-1|||-0.0838|-0.1529|<0.001
91766881|NCT02831764|183423190|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.74|-1.53|||MMRM||Week 144, Bone ALP|||-1.53|-2.74|<0.001
91766882|NCT02831764|183423190|OTHER||Mean Difference (Net)|-3.89|||<|0.001|TWO_SIDED|95.0|-4.87|-2.91|||MMRM||Week 144, Serum Osteocalcin|||-2.91|-4.87|<0.001
91766883|NCT02831764|183423190|OTHER||Mean Difference (Net)|-9.5|||<|0.001|TWO_SIDED|95.0|-12.8|-6.2|||MMRM||Week 144, Serum PINP|||-6.2|-12.8|<0.001
91766884|NCT02831764|183423190|OTHER||Mean Difference (Net)|-0.1364|||<|0.001|TWO_SIDED|95.0|-0.1739|-0.0988|||MMRM||Week 144, CTX-1|||-0.0988|-0.1739|<0.001
91766885|NCT02831764|183423191|OTHER||Mean Difference (Net)|-4.2||||0.015|TWO_SIDED|95.0|-7.5|-0.8|||MMRM||Week 24|||-0.8|-7.5|0.015
91766886|NCT02831764|183423191|OTHER||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.8|2.6|||MMRM||Week 48|||2.6|-2.8|0.960
91766887|NCT02831764|183423192|OTHER||Mean Difference (Net)|-3.0||||0.048|TWO_SIDED|95.0|-5.9|0.0|||MMRM||Week 96, Serum Vitamin D|||0.0|-5.9|0.048
91766888|NCT02831764|183423193|OTHER||Mean Difference (Net)|-0.2||||0.887|TWO_SIDED|95.0|-3.6|3.1|||MMRM||Week 144, Serum Vitamin D|||3.1|-3.6|0.887
91766889|NCT02831764|183423200|OTHER||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.5|5.6|||Fisher Exact||Week 24|||5.6|1.5|<0.001
91766890|NCT02831764|183423200|OTHER||Mean Difference (Final Values)|2.8||||0.037|TWO_SIDED|95.0|0.2|5.4|||Fisher Exact||Week 48|||5.4|0.2|0.037
91766891|NCT02831764|183423201|OTHER||Mean Difference (Final Values)|3.1||||0.045|TWO_SIDED|95.0|0.2|6.1|||Fisher Exact||Week 96|||6.1|0.2|0.045
91766892|NCT02831764|183423202|OTHER||Mean Difference (Final Values)|2.6||||0.16|TWO_SIDED|95.0|-0.8|6.0|||Fisher Exact||Week 144|||6.0|-0.8|0.160
91766893|NCT02831764|183423207|OTHER||Mean Difference (Net)|37.8|||||TWO_SIDED|95.0|9.98|65.62|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||65.62|9.98|
91766894|NCT02831764|183423207|OTHER||Mean Difference (Net)|-26.81|||||TWO_SIDED|95.0|-82.72|29.1|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||29.10|-82.72|
91766895|NCT02831764|183423207|OTHER||Mean Difference (Net)|61.72|||||TWO_SIDED|95.0|-26.94|150.39|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||150.39|-26.94|
91551302|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|6.629|||<|0.0001|TWO_SIDED|95.0|3.68|9.577|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.577|3.680|<.0001
91551303|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.083||||0.0072|TWO_SIDED|95.0|1.118|7.047|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.047|1.118|0.0072
91551304|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.688||||0.0023|TWO_SIDED|95.0|1.691|7.686|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.686|1.691|0.0023
91766896|NCT02831764|183423207|OTHER||Mean Difference (Net)|22.57|||||TWO_SIDED|95.0|-3.42|48.55|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||48.55|-3.42|
91766897|NCT02831764|183423207|OTHER||Mean Difference (Net)|38.99|||||TWO_SIDED|95.0|5.88|72.09|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||72.09|5.88|
91766898|NCT02831764|183423207|OTHER||Mean Difference (Net)|-9.9|||||TWO_SIDED|95.0|-53.1|33.3|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||33.30|-53.10|
91766899|NCT02831764|183423207|OTHER||Mean Difference (Net)|65.53|||||TWO_SIDED|95.0|-14.43|145.5|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||145.50|-14.43|
91766900|NCT02831764|183423207|OTHER||Mean Difference (Net)|59.66|||||TWO_SIDED|95.0|-8.62|127.94|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||127.94|-8.62|
91766901|NCT02831764|183423207|OTHER||Mean Difference (Net)|19.23|||||TWO_SIDED|95.0|-7.65|46.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.10|-7.65|
91766902|NCT02831764|183423207|OTHER||Mean Difference (Net)|19.04|||||TWO_SIDED|95.0|-11.06|49.13|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||49.13|-11.06|
91766903|NCT02831764|183423207|OTHER||Mean Difference (Net)|43.25|||||TWO_SIDED|95.0|-30.59|117.09|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||117.09|-30.59|
91551305|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.112|||<|0.0001|TWO_SIDED|95.0|2.874|7.35|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.350|2.874|<.0001
91551306|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.777||||0.603|TWO_SIDED|95.0|-2.165|3.72|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.720|-2.165|0.6030
91551307|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.003||||0.5053|TWO_SIDED|95.0|-1.96|3.967|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.967|-1.960|0.5053
91551308|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.674||||0.6607|TWO_SIDED|95.0|-2.347|3.694|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.694|-2.347|0.6607
91766904|NCT02831764|183423207|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-72.14|97.73|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||97.73|-72.14|
91766905|NCT02831764|183423207|OTHER||Mean Difference (Net)|62.01|||||TWO_SIDED|95.0|-16.09|140.12|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||140.12|-16.09|
91766906|NCT02831764|183423208|OTHER||Mean Difference (Net)|6.9|||||TWO_SIDED|95.0|-22.7|36.6|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||36.6|-22.7|
91766907|NCT02831764|183423208|OTHER||Mean Difference (Net)|13.2|||||TWO_SIDED|95.0|-46.8|73.2|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||73.2|-46.8|
91766908|NCT02831764|183423208|OTHER||Mean Difference (Net)|57.7|||||TWO_SIDED|95.0|-37.2|152.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||152.5|-37.2|
91766909|NCT02831764|183423208|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-23.5|31.7|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||31.7|-23.5|
91766910|NCT02831764|183423208|OTHER||Mean Difference (Net)|32.5|||||TWO_SIDED|95.0|-2.7|67.7|||||Age Group-1,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||67.7|-2.7|
91766911|NCT02831764|183423208|OTHER||Mean Difference (Net)|-31.5|||||TWO_SIDED|95.0|-77.1|14.2|||||Age Group-1,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||14.2|-77.1|
91551309|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.809||||0.1309|TWO_SIDED|95.0|-0.827|10.446|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.446|-0.827|0.1309
91551310|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.553||||0.9776|TWO_SIDED|95.0|-4.212|7.318|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.318|-4.212|0.9776
91766912|NCT02831764|183423208|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-81.4|91.8|||||Age Group-1,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.8|-81.4|
91766913|NCT02831764|183423208|OTHER||Mean Difference (Net)|8.6|||||TWO_SIDED|95.0|-19.4|36.5|||||Age Group-2, \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||36.5|-19.4|
91766914|NCT02831764|183423208|OTHER||Mean Difference (Net)|4.5|||||TWO_SIDED|95.0|-82.3|91.3|||||Age Group-2, \>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.3|-82.3|
91766915|NCT02831764|183423208|OTHER||Mean Difference (Net)|-27.3|||||TWO_SIDED|95.0|-100.8|46.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.1|-100.8|
91766916|NCT02831764|183423208|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-15.7|41.2|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||41.2|-15.7|
91766917|NCT02831764|183423208|OTHER||Mean Difference (Net)|11.3|||||TWO_SIDED|95.0|-20.4|43.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||43.1|-20.4|
91766918|NCT02831764|183423208|OTHER||Mean Difference (Net)|-37.8|||||TWO_SIDED|95.0|-119.6|44.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||44.0|-119.6|
91766919|NCT02831764|183423208|OTHER||Mean Difference (Net)|15.6|||||TWO_SIDED|95.0|-74.4|105.7|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||105.7|-74.4|
91766920|NCT02831764|183423208|OTHER||Mean Difference (Net)|37.6|||||TWO_SIDED|95.0|-45.4|120.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||120.5|-45.4|
91766921|NCT02831764|183423209|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-34.1|35.0|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||35.0|-34.1|
91766922|NCT02831764|183423209|OTHER||Mean Difference (Net)|14.7|||||TWO_SIDED|95.0|-55.6|84.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||84.9|-55.6|
91551311|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.862||||0.1422|TWO_SIDED|95.0|-0.939|10.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.663|-0.939|0.1422
91551312|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.851||||0.0334|TWO_SIDED|95.0|0.307|11.396|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||11.396|0.307|0.0334
91551313|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.08||||0.5622|TWO_SIDED|95.0|-2.501|8.66|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.660|-2.501|0.5622
91551314|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.014||||0.2841|TWO_SIDED|95.0|-1.643|9.672|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.672|-1.643|0.2841
91551315|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.438||||0.0178|TWO_SIDED|95.0|0.774|8.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.103|0.774|0.0178
91766923|NCT02831764|183423209|OTHER||Mean Difference (Net)|26.5|||||TWO_SIDED|95.0|-87.3|140.3|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||140.3|-87.3|
91766924|NCT02831764|183423209|OTHER||Mean Difference (Net)|2.8|||||TWO_SIDED|95.0|-29.4|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-29.4|
91766925|NCT02831764|183423209|OTHER||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|-32.5|49.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.1|-32.5|
91766926|NCT02831764|183423209|OTHER||Mean Difference (Net)|-13.3|||||TWO_SIDED|95.0|-67.6|41.1|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||41.1|-67.6|
91766927|NCT02831764|183423209|OTHER||Mean Difference (Net)|32.7|||||TWO_SIDED|95.0|-68.5|133.9|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||133.9|-68.5|
91551316|NCT04800211|182986281|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.847||||0.6944|TWO_SIDED|95.0|-3.398|5.093|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.093|-3.398|0.6944
91766928|NCT02831764|183423209|OTHER||Mean Difference (Net)|5.1|||||TWO_SIDED|95.0|-80.7|90.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||90.8|-80.7|
91766929|NCT02831764|183423209|OTHER||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-31.1|35.3|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||35.3|-31.1|
91766930|NCT02831764|183423209|OTHER||Mean Difference (Net)|13.7|||||TWO_SIDED|95.0|-23.2|50.6|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||50.6|-23.2|
91766931|NCT02831764|183423209|OTHER||Mean Difference (Net)|-57.4|||||TWO_SIDED|95.0|-155.3|40.4|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||40.4|-155.3|
91766932|NCT02831764|183423209|OTHER||Mean Difference (Net)|-40.1|||||TWO_SIDED|95.0|-144.2|64.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||64.0|-144.2|
91766933|NCT02831764|183423209|OTHER||Mean Difference (Net)|33.1|||||TWO_SIDED|95.0|-63.3|129.6|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.6|-63.3|
91766934|NCT02831764|183423210|OTHER||Mean Difference (Net)|9.1|||||TWO_SIDED|95.0|-31.1|49.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||49.2|-31.1|
91766935|NCT02831764|183423210|OTHER||Mean Difference (Net)|-16.6|||||TWO_SIDED|95.0|-98.9|65.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||65.8|-98.9|
91766936|NCT02831764|183423210|OTHER||Mean Difference (Net)|56.0|||||TWO_SIDED|95.0|-77.2|189.1|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||189.1|-77.2|
91766937|NCT02831764|183423210|OTHER||Mean Difference (Net)|2.4|||||TWO_SIDED|95.0|-35.2|39.9|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||39.9|-35.2|
91766938|NCT02831764|183423210|OTHER||Mean Difference (Net)|25.8|||||TWO_SIDED|95.0|-22.3|74.0|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||74.0|-22.3|
91766939|NCT02831764|183423210|OTHER||Mean Difference (Net)|-36.4|||||TWO_SIDED|95.0|-98.6|25.8|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||25.8|-98.6|
91766940|NCT02831764|183423210|OTHER||Mean Difference (Net)|24.1|||||TWO_SIDED|95.0|-89.0|137.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||137.2|-89.0|
91766941|NCT02831764|183423210|OTHER||Mean Difference (Net)|-26.9|||||TWO_SIDED|95.0|-125.9|72.2|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||72.2|-125.9|
91766942|NCT02831764|183423210|OTHER||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-30.3|46.5|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.5|-30.3|
91766943|NCT02831764|183423210|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-39.4|46.3|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||46.3|-39.4|
91766944|NCT02831764|183423210|OTHER||Mean Difference (Net)|-121.2|||||TWO_SIDED|95.0|-237.2|-5.1|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||-5.1|-237.2|
91766945|NCT02831764|183423210|OTHER||Mean Difference (Net)|13.1|||||TWO_SIDED|95.0|-106.4|132.6|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||132.6|-106.4|
91766946|NCT02831764|183423210|OTHER||Mean Difference (Net)|114.3|||||TWO_SIDED|95.0|4.6|224.0|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||224.0|4.6|
91766947|NCT02831764|183423211|OTHER||Mean Difference (Net)|-0.0019||||0.759|TWO_SIDED|95.0|-0.0137|0.01|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0100|-0.0137|0.759
91551317|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-35.556||||0.0031|TWO_SIDED|95.0|-59.038|-12.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-12.075|-59.038|0.0031
91551318|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-31.35||||0.0371|TWO_SIDED|95.0|-60.818|-1.882|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.882|-60.818|0.0371
91551319|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-34.356||||0.0043|TWO_SIDED|95.0|-57.877|-10.834|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-10.834|-57.877|0.0043
91551320|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-18.096||||0.2091|TWO_SIDED|95.0|-46.375|10.183|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||10.183|-46.375|0.2091
91551321|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-24.723||||0.0197|TWO_SIDED|95.0|-45.473|-3.973|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-3.973|-45.473|0.0197
91766948|NCT02831764|183423211|OTHER||Mean Difference (Net)|0.0003||||0.943|TWO_SIDED|95.0|-0.0088|0.0095|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0095|-0.0088|0.943
91766949|NCT02831764|183423211|OTHER||Mean Difference (Net)|-0.0019||||0.703|TWO_SIDED|95.0|-0.0117|0.0079|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0079|-0.0117|0.703
91766950|NCT02831764|183423212|OTHER||Mean Difference (Net)|-0.0003||||0.957|TWO_SIDED|95.0|-0.011|0.0104|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0104|-0.0110|0.957
91766951|NCT02831764|183423213|OTHER||Mean Difference (Net)|0.0079||||0.162|TWO_SIDED|95.0|-0.0032|0.0189|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0189|-0.0032|0.162
91551322|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-13.595||||0.2353|TWO_SIDED|95.0|-36.08|8.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||8.891|-36.080|0.2353
91551323|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-4.759||||0.7329|TWO_SIDED|95.0|-32.159|22.641|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||22.641|-32.159|0.7329
91551324|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-21.962||||0.542|TWO_SIDED|95.0|-62.989|19.065|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||19.065|-62.989|0.5420
91551325|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.591||||0.5234|TWO_SIDED|95.0|-77.049|23.866|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||23.866|-77.049|0.5234
91551326|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-20.761||||0.5975|TWO_SIDED|95.0|-61.867|20.344|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||20.344|-61.867|0.5975
91766952|NCT02831764|183423214|OTHER||Mean Difference (Net)|-1.3||||0.045|TWO_SIDED|95.0|-2.6|0.0|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0|-2.6|0.045
91766953|NCT02831764|183423214|OTHER||Mean Difference (Net)|-0.6||||0.358|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-1.9|0.358
91766954|NCT02831764|183423214|OTHER||Mean Difference (Net)|-0.6||||0.328|TWO_SIDED|95.0|-1.9|0.6|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.6|-1.9|0.328
91766955|NCT02831764|183423215|OTHER||Mean Difference (Net)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-2.1|0.318
91551327|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.337||||0.9331|TWO_SIDED|95.0|-62.853|36.179|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||36.179|-62.853|0.9331
91551328|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-19.964||||0.2444|TWO_SIDED|95.0|-53.637|13.709|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||13.709|-53.637|0.2444
91551329|NCT04800211|182986282|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.254||||0.5169|TWO_SIDED|95.0|-53.427|26.919|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||26.919|-53.427|0.5169
91551330|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.174||||0.1359|TWO_SIDED|95.0|-93.12|12.772|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||12.772|-93.120|0.1359
91551331|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-71.725||||0.0129|TWO_SIDED|95.0|-127.961|-15.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.490|-127.961|0.0129
91551332|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.308||||0.3262|TWO_SIDED|95.0|-112.293|37.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||37.678|-112.293|0.3262
91551333|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-20.012||||0.4343|TWO_SIDED|95.0|-70.468|30.444|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.444|-70.468|0.4343
91551334|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.657||||0.0967|TWO_SIDED|95.0|-97.481|8.167|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.167|-97.481|0.0967
91551335|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.974||||0.4198|TWO_SIDED|95.0|-99.915|41.966|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||41.966|-99.915|0.4198
91551336|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-33.141||||0.2121|TWO_SIDED|95.0|-85.475|19.193|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||19.193|-85.475|0.2121
91766956|NCT02831764|183423216|OTHER||Mean Difference (Net)|0.3||||0.674|TWO_SIDED|95.0|-1.0|1.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||1.6|-1.0|0.674
91766957|NCT01790594|183423220|SUPERIORITY||Mean Difference (Final Values)|2.088||||0.75|TWO_SIDED|95.0|-11.067|15.242|||Mixed Models Analysis|||The p-value compares Investigational arm and control arm.||15.242|-11.067|0.750
91766958|NCT00669214|183423259|SUPERIORITY_OR_OTHER||Difference in proportion|0.163||||0.1054||95.0|-0.063|0.393|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.393|-0.063|0.1054
91766959|NCT00669214|183423261|SUPERIORITY_OR_OTHER||Difference in proportion|0.155||||0.2404||95.0|-0.072|0.388|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.388|-0.072|0.2404
91766960|NCT00669214|183423263|SUPERIORITY_OR_OTHER||Difference in proportion|0.228||||0.0366||95.0|0.003|0.452|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.452|0.003|0.0366
91766961|NCT00669214|183423265|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|3.33||||0.1816||95.0|-2.811|9.471|||Student T-test|||||9.471|-2.811|0.1816
91766962|NCT00669214|183423267|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|1.19||||0.0435||95.0|-0.161|2.532|||Student T-test|||||2.532|-0.161|0.0435
91766963|NCT00669214|183423269|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Wilcoxon rank sum|||||||0.0224
91766964|NCT00346216|183423277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.|Hazard Ratio (HR)|0.93||||0.0002|TWO_SIDED|95.0|0.76|1.13||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.13|0.76|0.0002
91551337|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|15.799||||0.5445|TWO_SIDED|95.0|-35.614|67.212|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||67.212|-35.614|0.5445
91551338|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.583||||0.9534|TWO_SIDED|95.0|-51.951|55.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||55.116|-51.951|0.9534
91551339|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|7.584||||0.8366|TWO_SIDED|95.0|-65.126|80.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||80.295|-65.126|0.8366
91551340|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-55.973||||0.5437|TWO_SIDED|95.0|-154.862|42.916|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||42.916|-154.862|0.5437
91551341|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-73.308||||0.2974|TWO_SIDED|95.0|-177.224|30.608|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.608|-177.224|0.2974
91766965|NCT00346216|183423277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40|Hazard Ratio (HR)|0.9||||0.0001|TWO_SIDED|95.0|0.72|1.14||Non inferiority P value, α=0.025|Regression, Cox|||MITT Population||1.14|0.72|0.0001
91766966|NCT00346216|183423277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.0|0.7|1.04||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.04|0.70|<0.0001
91551342|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.892||||0.9026|TWO_SIDED|95.0|-181.909|92.126|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||92.126|-181.909|0.9026
91551343|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-35.811||||0.8954|TWO_SIDED|95.0|-132.513|60.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||60.891|-132.513|0.8954
91551344|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-46.239||||0.7485|TWO_SIDED|95.0|-146.766|54.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||54.288|-146.766|0.7485
91551345|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-36.559||||0.9578|TWO_SIDED|95.0|-169.77|96.653|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||96.653|-169.770|0.9578
91766967|NCT00346216|183423277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|0.81|||<|0.0001|TWO_SIDED|95.0|0.64|1.02||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.02|0.64|<0.0001
91766968|NCT00346216|183423277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33|Hazard Ratio (HR)|1.08||||0.0182|TWO_SIDED|95.0|0.89|1.31||Non-inferiority P-value, α=0.025|Regression, Cox|||ITT Population||1.31|0.89|0.0182
91766969|NCT00346216|183423277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|1.12||||0.025|TWO_SIDED|95.0|0.89|1.4||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.40|0.89|0.0250
91766970|NCT00346216|183423278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.6427|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||ITT Population||1.12|0.83|0.6427
91766971|NCT00346216|183423278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.0597|TWO_SIDED|95.0|0.75|1.01|||Regression, Cox|||ITT Population||1.01|0.75|0.0597
91766972|NCT00346216|183423278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11||||0.1481|TWO_SIDED|95.0|0.96|1.29|||Regression, Cox|||ITT Population||1.29|0.96|0.1481
91766973|NCT00346216|183423278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.5758|TWO_SIDED|95.0|0.8|1.13|||Regression, Cox|||MITT Population||1.13|0.80|0.5758
91766974|NCT00346216|183423278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0204|TWO_SIDED|95.0|0.69|0.97|||Regression, Cox|||MITT Population||0.97|0.69|0.0204
91766975|NCT00346216|183423278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.0751|TWO_SIDED|95.0|0.98|1.38|||Regression, Cox|||MITT Population||1.38|0.98|0.0751
91766976|NCT00346216|183423279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8576|TWO_SIDED|95.0|0.67|1.4|||Regression, Cox|||ITT Population||1.40|0.67|0.8576
91551346|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.725||||0.3635|TWO_SIDED|95.0|-129.208|47.757|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||47.757|-129.208|0.3635
91551347|NCT04800211|182986283|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-8.333||||0.8713|TWO_SIDED|95.0|-110.097|93.431|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||93.431|-110.097|0.8713
91551348|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-115.256||||0.0003|TWO_SIDED|95.0|-177.973|-52.539|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-52.539|-177.973|0.0003
91551349|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-74.904||||0.0467|TWO_SIDED|95.0|-148.706|-1.102|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.102|-148.706|0.0467
91551350|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-144.035|||<|0.0001|TWO_SIDED|95.0|-206.668|-81.402|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-81.402|-206.668|<.0001
91551351|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-62.755||||0.0807|TWO_SIDED|95.0|-133.221|7.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||7.710|-133.221|0.0807
91766977|NCT00346216|183423279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.1202|TWO_SIDED|95.0|0.53|1.08|||Regression, Cox|||ITT Population||1.08|0.53|0.1202
91766978|NCT00346216|183423279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.27||||0.1734|TWO_SIDED|95.0|0.9|1.81|||Regression, Cox|||ITT Population||1.81|0.90|0.1734
91766979|NCT00346216|183423279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0041|TWO_SIDED|95.0|0.32|0.81|||Regression, Cox|||MITT Population||0.81|0.32|0.0041
91766980|NCT00346216|183423279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.0003|TWO_SIDED|95.0|0.27|0.68|||Regression, Cox|||MITT Population||0.68|0.27|0.0003
91551352|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-68.83||||0.0095|TWO_SIDED|95.0|-120.753|-16.907|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-16.907|-120.753|0.0095
91551353|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-1.593||||0.9586|TWO_SIDED|95.0|-61.873|58.687|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||58.687|-61.873|0.9586
91551354|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.635||||0.9402|TWO_SIDED|95.0|-71.714|66.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||66.443|-71.714|0.9402
91551355|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-113.663||||0.039|TWO_SIDED|95.0|-223.33|-3.996|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-3.996|-223.330|0.0390
91551356|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-72.269||||0.4543|TWO_SIDED|95.0|-199.091|54.554|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||54.554|-199.091|0.4543
91551357|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-142.442||||0.0051|TWO_SIDED|95.0|-252.08|-32.805|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-32.805|-252.080|0.0051
91551358|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-60.12||||0.6061|TWO_SIDED|95.0|-184.286|64.046|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||64.046|-184.286|0.6061
91766981|NCT00346216|183423279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.4243|TWO_SIDED|95.0|0.8|1.69|||Regression, Cox|||MITT Population||1.69|0.80|0.4243
91551359|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-66.194||||0.1242|TWO_SIDED|95.0|-150.672|18.284|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||18.284|-150.672|0.1242
91551360|NCT04800211|182986284|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-12.149||||0.8117|TWO_SIDED|95.0|-112.35|88.052|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||88.052|-112.350|0.8117
91551361|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.957||||0.0567|TWO_SIDED|95.0|-227.151|3.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.237|-227.151|0.0567
91551362|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-76.728||||0.2103|TWO_SIDED|95.0|-197.025|43.569|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.569|-197.025|0.2103
91551363|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-169.735||||0.0052|TWO_SIDED|95.0|-288.22|-51.251|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-51.251|-288.220|0.0052
91766982|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|1.01|2.53|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||2.53|1.01|<0.0001
91766983|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.39||0.0373|TWO_SIDED|95.0|0.05|1.56|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.56|0.05|0.0373
91766984|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.39||0.0129|TWO_SIDED|95.0|0.2|1.72|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.72|0.20|0.0129
91766985|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.39||0.183|TWO_SIDED|95.0|-0.25|1.29|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.29|-0.25|0.1830
91766986|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.39||0.7777|TWO_SIDED|95.0|-0.88|0.66|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||0.66|-0.88|0.7777
91551364|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-52.505||||0.349|TWO_SIDED|95.0|-162.721|57.711|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||57.711|-162.721|0.3490
91551365|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-11.413||||0.841|TWO_SIDED|95.0|-123.333|100.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||100.507|-123.333|0.8410
91551366|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-53.565||||0.3465|TWO_SIDED|95.0|-165.4|58.27|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||58.270|-165.400|0.3465
91551367|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.65||||0.0087|TWO_SIDED|95.0|-194.865|-28.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-28.435|-194.865|0.0087
91551368|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|63.944||||0.2688|TWO_SIDED|95.0|-49.678|177.565|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||177.565|-49.678|0.2688
91551369|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|151.222||||0.0096|TWO_SIDED|95.0|37.114|265.33|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||265.330|37.114|0.0096
91766987|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.39||0.1072|TWO_SIDED|95.0|-0.14|1.4|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.40|-0.14|0.1072
91551370|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|182.631||||0.0023|TWO_SIDED|95.0|65.754|299.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||299.509|65.754|0.0023
91551371|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-175.901||||0.1612|TWO_SIDED|95.0|-390.865|39.063|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||39.063|-390.865|0.1612
91551372|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-227.95||||0.0396|TWO_SIDED|95.0|-448.725|-7.175|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-7.175|-448.725|0.0396
91551373|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-352.366||||0.0002|TWO_SIDED|95.0|-573.315|-131.418|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-131.418|-573.315|0.0002
91766988|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.12|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.46|-0.12|0.8237
91766989|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||0.70|-0.88|0.8237
91766990|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.4||0.0587|TWO_SIDED|95.0|-0.03|1.55|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.55|-0.03|0.0587
91766991|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.41||0.3129|TWO_SIDED|95.0|-0.39|1.23|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.23|-0.39|0.3129
91766992|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.6526|TWO_SIDED|95.0|-0.63|1.0|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.00|-0.63|0.6526
91766993|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5774|TWO_SIDED|95.0|-0.58|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.05|-0.58|0.5774
91551374|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.449||||0.5616|TWO_SIDED|95.0|-327.445|94.547|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||94.547|-327.445|0.5616
91551375|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-162.635||||0.2176|TWO_SIDED|95.0|-375.57|50.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||50.299|-375.570|0.2176
91551376|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-236.196||||0.0242|TWO_SIDED|95.0|-451.334|-21.059|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-21.059|-451.334|0.0242
91551377|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-294.281|||<|0.0001|TWO_SIDED|95.0|-434.513|-154.05|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-154.050|-434.513|<.0001
91551378|NCT04800211|182986285|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.17||||0.1524|TWO_SIDED|95.0|-275.521|43.18|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.180|-275.521|0.1524
91766994|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.42||0.0632|TWO_SIDED|95.0|-0.04|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.62|-0.04|0.0632
91766995|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.43||0.454|TWO_SIDED|95.0|-0.52|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.15|-0.52|0.4540
91766996|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.43||0.2705|TWO_SIDED|95.0|-0.37|1.3|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.30|-0.37|0.2705
91766997|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.44||0.5225|TWO_SIDED|95.0|-0.58|1.14|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.14|-0.58|0.5225
91551379|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-32.792|||<|0.0001|TWO_SIDED|95.0|-39.375|-26.208|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-26.208|-39.375|<.0001
91551380|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-25.921|||<|0.0001|TWO_SIDED|95.0|-33.398|-18.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-18.443|-33.398|<.0001
91551381|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.484|||<|0.0001|TWO_SIDED|95.0|-31.99|-18.979|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-18.979|-31.990|<.0001
91551382|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.899|||<|0.0001|TWO_SIDED|95.0|-34.135|-19.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-19.663|-34.135|<.0001
91551383|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.41|||<|0.0001|TWO_SIDED|95.0|-31.716|-21.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-21.103|-31.716|<.0001
91551384|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-7.021||||0.028|TWO_SIDED|95.0|-13.278|-0.763|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-0.763|-13.278|0.0280
91551385|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-5.902||||0.0972|TWO_SIDED|95.0|-12.881|1.077|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.077|-12.881|0.0972
91766998|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.44||0.5996|TWO_SIDED|95.0|-1.1|0.63|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||0.63|-1.10|0.5996
91766999|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.44||0.2461|TWO_SIDED|95.0|-0.35|1.38|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.38|-0.35|0.2461
91767000|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.46||0.8127|TWO_SIDED|95.0|-0.79|1.0|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.00|-0.79|0.8127
91551386|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.771|||<|0.0001|TWO_SIDED|95.0|-37.189|-14.353|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-14.353|-37.189|<.0001
91767001|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.46||0.9641|TWO_SIDED|95.0|-0.92|0.87|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||0.87|-0.92|0.9641
91767002|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.46||0.7784|TWO_SIDED|95.0|-0.77|1.03|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.03|-0.77|0.7784
91767003|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.49||0.2105|TWO_SIDED|95.0|-0.34|1.56|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.56|-0.34|0.2105
91551387|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.019||||0.0005|TWO_SIDED|95.0|-32.833|-7.205|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.205|-32.833|0.0005
91551388|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-18.463||||0.0002|TWO_SIDED|95.0|-29.825|-7.101|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-7.101|-29.825|0.0002
91767004|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.2909|TWO_SIDED|95.0|-0.44|1.46|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.46|-0.44|0.2909
91767005|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.49||0.8459|TWO_SIDED|95.0|-0.86|1.05|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.05|-0.86|0.8459
91767006|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.51||0.1116|TWO_SIDED|95.0|-0.19|1.8|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.80|-0.19|0.1116
91767007|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.51||0.9751|TWO_SIDED|95.0|-0.98|1.01|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.01|-0.98|0.9751
91767008|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.51||0.1202|TWO_SIDED|95.0|-0.21|1.79|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.79|-0.21|0.1202
91767009|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.52||0.3767|TWO_SIDED|95.0|-0.56|1.48|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||1.48|-0.56|0.3767
91767010|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1123|TWO_SIDED|95.0|-1.85|0.19|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||0.19|-1.85|0.1123
91767011|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.52||0.0137|TWO_SIDED|95.0|0.26|2.31|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||2.31|0.26|0.0137
91767012|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|1.07|2.47|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||2.47|1.07|<0.0001
91767013|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.36||0.0197|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.54|0.13|0.0197
91767014|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.36||0.0094|TWO_SIDED|95.0|0.23|1.64|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.64|0.23|0.0094
91551389|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.997||||0.0002|TWO_SIDED|95.0|-33.619|-8.375|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-8.375|-33.619|0.0002
91551390|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.508|||<|0.0001|TWO_SIDED|95.0|-29.061|-11.955|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-11.955|-29.061|<.0001
91551391|NCT04800211|182986286|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.978||||0.8504|TWO_SIDED|95.0|-9.216|11.172|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||11.172|-9.216|0.8504
91551392|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.257|||<|0.0001|TWO_SIDED|95.0|-41.957|-20.557|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-20.557|-41.957|<.0001
91551393|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-29.862|||<|0.0001|TWO_SIDED|95.0|-44.234|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-44.234|<.0001
91551394|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.512|||<|0.0001|TWO_SIDED|95.0|-46.971|-16.053|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-16.053|-46.971|<.0001
91767015|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.37||0.1247|TWO_SIDED|95.0|-0.16|1.31|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.31|-0.16|0.1247
91551395|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.197|||<|0.0001|TWO_SIDED|95.0|-47.522|-26.872|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-26.872|-47.522|<.0001
91551396|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.442|||<|0.0001|TWO_SIDED|95.0|-44.96|-17.923|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-17.923|-44.960|<.0001
91551397|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.597||||0.0002|TWO_SIDED|95.0|-43.34|-13.853|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.853|-43.340|0.0002
91551398|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-30.054|||<|0.0001|TWO_SIDED|95.0|-40.943|-19.166|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-19.166|-40.943|<.0001
91551399|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-5.904||||0.2667|TWO_SIDED|95.0|-16.37|4.563|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.563|-16.370|0.2667
91767016|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.37||0.8278|TWO_SIDED|95.0|-0.81|0.65|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||0.65|-0.81|0.8278
91767017|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.0802|TWO_SIDED|95.0|-0.08|1.39|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.39|-0.08|0.0802
91767018|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.39||0.0822|TWO_SIDED|95.0|-0.09|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.46|-0.09|0.0822
91767019|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.39||0.8314|TWO_SIDED|95.0|-0.86|0.69|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||0.69|-0.86|0.8314
91767020|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.39||0.0516|TWO_SIDED|95.0|-0.01|1.54|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.54|-0.01|0.0516
91551400|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|8.767||||0.2085|TWO_SIDED|95.0|-4.95|22.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||22.485|-4.950|0.2085
91551401|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|12.455||||0.1041|TWO_SIDED|95.0|-2.595|27.505|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||27.505|-2.595|0.1041
91551402|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-25.353||||0.0058|TWO_SIDED|95.0|-45.41|-5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-5.295|-45.410|0.0058
91551403|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-38.63||||0.001|TWO_SIDED|95.0|-65.062|-12.197|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-12.197|-65.062|0.0010
91551404|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-43.967||||0.0005|TWO_SIDED|95.0|-72.443|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-72.443|0.0005
91767021|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.42||0.3202|TWO_SIDED|95.0|-0.4|1.24|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.24|-0.40|0.3202
91767022|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5893|TWO_SIDED|95.0|-0.6|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.05|-0.60|0.5893
91767023|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.42||0.651|TWO_SIDED|95.0|-0.63|1.01|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.01|-0.63|0.6510
91767024|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.44||0.0796|TWO_SIDED|95.0|-0.09|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.62|-0.09|0.0796
91551405|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.293||||0.0003|TWO_SIDED|95.0|-51.159|-11.428|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-11.428|-51.159|0.0003
91767025|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.44||0.5061|TWO_SIDED|95.0|-0.57|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.15|-0.57|0.5061
91767026|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.44||0.2796|TWO_SIDED|95.0|-0.38|1.33|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.33|-0.38|0.2796
91551406|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.209||||0.0004|TWO_SIDED|95.0|-65.941|-14.477|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-14.477|-65.941|0.0004
91551407|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-41.052||||0.0011|TWO_SIDED|95.0|-68.965|-13.138|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.138|-68.965|0.0011
91551408|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.509|||<|0.0001|TWO_SIDED|95.0|-60.902|-24.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-24.116|-60.902|<.0001
91767027|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.45||0.6725|TWO_SIDED|95.0|-0.69|1.08|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.08|-0.69|0.6725
91767028|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.45||0.6381|TWO_SIDED|95.0|-1.1|0.67|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||0.67|-1.10|0.6381
91767029|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.45||0.3737|TWO_SIDED|95.0|-0.49|1.29|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.29|-0.49|0.3737
91767030|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9139|TWO_SIDED|95.0|-0.87|0.97|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.97|-0.87|0.9139
91767031|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9998|TWO_SIDED|95.0|-0.92|0.92|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.92|-0.92|0.9998
91767032|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9144|TWO_SIDED|95.0|-0.88|0.98|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.98|-0.88|0.9144
91767033|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.51||0.225|TWO_SIDED|95.0|-0.38|1.61|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.61|-0.38|0.2250
91551409|NCT04800211|182986287|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-2.915||||0.7835|TWO_SIDED|95.0|-23.855|18.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||18.025|-23.855|0.7835
91551410|NCT04800211|182986288|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.769||||0.0002|TWO_SIDED|95.0|-1.228|-0.309|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.309|-1.228|0.0002
91551411|NCT04800211|182986288|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.52||||0.0175|TWO_SIDED|95.0|-0.972|-0.068|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.068|-0.972|0.0175
91551412|NCT04800211|182986289|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|2.408||||0.0362|TWO_SIDED|95.0|0.11|4.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||4.705|0.110|0.0362
91551413|NCT04800211|182986289|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.692||||0.2142|TWO_SIDED|95.0|-0.569|3.953|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.953|-0.569|0.2142
91551414|NCT04800211|182986290|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-39.501||||0.025|TWO_SIDED|95.0|-75.396|-3.605|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-3.605|-75.396|0.0250
91767034|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.2758|TWO_SIDED|95.0|-0.44|1.55|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.55|-0.44|0.2758
91767035|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.51||0.903|TWO_SIDED|95.0|-0.94|1.06|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.06|-0.94|0.9030
91767036|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.53||0.091|TWO_SIDED|95.0|-0.14|1.94|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.94|-0.14|0.0910
91767037|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.53||0.7668|TWO_SIDED|95.0|-0.88|1.2|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.20|-0.88|0.7668
91767038|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.53||0.1653|TWO_SIDED|95.0|-0.31|1.78|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.78|-0.31|0.1653
91551415|NCT04800211|182986290|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.94||||0.9997|TWO_SIDED|95.0|-37.896|32.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||32.016|-37.896|0.9997
91551416|NCT04800211|182986291|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-54.398||||0.6778|TWO_SIDED|95.0|-177.281|68.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||68.485|-177.281|0.6778
91551417|NCT04800211|182986291|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-48.395||||0.7497|TWO_SIDED|95.0|-168.697|71.908|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||71.908|-168.697|0.7497
91767039|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.55||0.4323|TWO_SIDED|95.0|-0.65|1.52|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||1.52|-0.65|0.4323
91767040|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.55||0.1439|TWO_SIDED|95.0|-1.89|0.28|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||0.28|-1.89|0.1439
91767041|NCT00346216|183423280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.55||0.0251|TWO_SIDED|95.0|0.16|2.33|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||2.33|0.16|0.0251
91767042|NCT02163824|183423291|SUPERIORITY||Difference in % of responders|16.1||||0.0024|TWO_SIDED|95.0|5.9|26.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||26.4|5.9|.0024
91767043|NCT02163824|183423291|SUPERIORITY||Difference in % of responders|22.1|||<|0.0001|TWO_SIDED|95.0|11.7|32.6|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||32.6|11.7|<.0001
91767044|NCT02163824|183423292|SUPERIORITY||Difference in % of responders|19.5||||0.0019|TWO_SIDED|95.0|7.4|31.5|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||31.5|7.4|.0019
91551418|NCT04800211|182986292|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.01||||0.0003|TWO_SIDED|95.0|-32.447|-7.573|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.573|-32.447|0.0003
91767045|NCT02163824|183423292|SUPERIORITY||Difference in % of responders|22.5||||0.0003|TWO_SIDED|95.0|10.6|34.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||34.4|10.6|.0003
91767046|NCT02163824|183423293|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0007|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 8.|||||0.0007
91767047|NCT02163824|183423293|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean grade AC at Day 8.|||||0.0440
91767048|NCT02163824|183423294|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0391|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.0391
91551419|NCT04800211|182986292|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.566|||<|0.0001|TWO_SIDED|95.0|-34.837|-10.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-10.295|-34.837|<.0001
91551420|NCT04800211|182986293|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-179.365|||<|0.0001|TWO_SIDED|95.0|-225.708|-133.022|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-133.022|-225.708|<.0001
91767049|NCT02163824|183423294|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1811|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.1811
91767050|NCT02163824|183423295|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1953|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain grade at Day 8.|||||0.1953
91767051|NCT02163824|183423295|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0307|TWO_SIDED||||||ANCOVA||Estimated value is the between group difference of mean ocular pain grade at Day 8.|||||0.0307
91767052|NCT02163824|183423296|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2589|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference on mean ocular pain score at Day 15.|||||0.2589
91767053|NCT02163824|183423296|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2132|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain score at Day 15.|||||0.2132
91767054|NCT01794000|183423312|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.83||||0.117|TWO_SIDED|95.0|0.66|1.05|||Andersen-Gill model||The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.|The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.||1.05|0.66|.117
91767055|NCT01794000|183423313|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.242||||0.912|TWO_SIDED|95.0|-4.564|4.079||Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.079|-4.564|.912
91767056|NCT01794000|183423314|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.0968||||0.365|TWO_SIDED|95.0|-0.1132|0.3068||MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||0.3068|-0.1132|.365
91767057|NCT01794000|183423315|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.82||||0.109|TWO_SIDED|95.0|0.65|1.04||The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.|Andersen-Gill Model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.04|0.65|.109
91767058|NCT01794000|183423316|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.94||||0.759|TWO_SIDED|95.0|0.65|1.37||The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.37|0.65|.759
91551421|NCT04800211|182986293|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.22|||<|0.0001|TWO_SIDED|95.0|-198.93|-107.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-107.509|-198.930|<.0001
91551422|NCT04800211|182986294|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.569|||<|0.0001|TWO_SIDED|95.0|-3.084|-2.054|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.054|-3.084|<.0001
91551423|NCT04800211|182986294|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.092|-2.081|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.081|-3.092|<.0001
91551424|NCT04800211|182986296|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.42||||0.0839|TWO_SIDED|95.0|-0.19|3.04|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.04|-0.19|0.0839
91551425|NCT04800211|182986296|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|2.1||||0.0089|TWO_SIDED|95.0|0.53|3.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.66|0.53|0.0089
91551426|NCT04800211|182986297|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.26||||0.7101|TWO_SIDED|95.0|-1.13|1.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.66|-1.13|0.7101
91551427|NCT04800211|182986297|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.24||||0.7325|TWO_SIDED|95.0|-1.12|1.59|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.59|-1.12|0.7325
91767059|NCT01794000|183423317|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.96||||0.916|TWO_SIDED|95.0|0.48|1.93||The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.93|0.48|.916
91551428|NCT04800211|182986298|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.48||||0.0136|TWO_SIDED|95.0|0.31|2.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.66|0.31|0.0136
91551429|NCT04800211|182986298|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.94||||0.0009|TWO_SIDED|95.0|0.8|3.08|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.08|0.80|0.0009
91551430|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.038||||0.9294|TWO_SIDED|95.0|-0.795|0.87|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.870|-0.795|0.9294
91551431|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.277||||0.529|TWO_SIDED|95.0|-0.587|1.142|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.142|-0.587|0.5290
91551432|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.508||||0.2291|TWO_SIDED|95.0|-1.337|0.321|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.321|-1.337|0.2291
91551433|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.525||||0.2179|TWO_SIDED|95.0|-0.311|1.361|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.361|-0.311|0.2179
91551434|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.401||||0.2002|TWO_SIDED|95.0|-0.213|1.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.016|-0.213|0.2002
91767060|NCT01794000|183423318|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|1.17||||0.544|TWO_SIDED|95.0|0.71|1.91||The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.91|0.71|.544
91551435|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.29||||0.476|TWO_SIDED|95.0|-1.089|0.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.509|-1.089|0.4760
91551436|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.699||||0.0914|TWO_SIDED|95.0|-1.512|0.113|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.113|-1.512|0.0914
91551437|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.328||||0.9705|TWO_SIDED|95.0|-1.122|1.777|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.777|-1.122|0.9705
91551438|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.977||||0.328|TWO_SIDED|95.0|-0.512|2.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.465|-0.512|0.3280
91767061|NCT01794000|183423319|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.513||||0.602|TWO_SIDED|95.0|-4.186|7.213||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||7.213|-4.186|.602
91767062|NCT01794000|183423320|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.272||||0.459|TWO_SIDED|95.0|-2.109|4.652||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.652|-2.109|.459
91767063|NCT01794000|183423322|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.94||||0.662|TWO_SIDED|95.0|-3.31|5.19||The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.|ANCOVA||The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.|||5.19|-3.31|.662
91767064|NCT01794000|183423323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.317|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the First VOC||||.317
91767065|NCT01794000|183423323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the Second VOC||||.133
91767066|NCT01794000|183423324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.638|||||||Fisher Exact|||||||.638
91767067|NCT00796666|183423325|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8616||||0.5416|TWO_SIDED|95.0|0.602|1.233|||Log Rank|||||1.233|0.602|0.5416
91767068|NCT00796666|183423326|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||P-value was based on the analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO Functional Class (FC) as fixed effects and baseline 6 Minute Walk Distance (6MWD) as a covariate.|ANCOVA|||Baseline to Week 12||||0.0049
91767069|NCT00796666|183423327|SUPERIORITY_OR_OTHER|||||||0.8223|TWO_SIDED|||||Missing values at Week 12 and Week 24 were imputed with the last non-missing WHO FC based on the last observation carried forward (LOCF) method.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test used modified ridit scores and the p-value corresponding to the ANCOVA (row mean scores) statistic was reported.||Baseline to Week 12||||0.8223
91551439|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.218||||0.9951|TWO_SIDED|95.0|-1.667|1.23|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.230|-1.667|0.9951
91551440|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.225||||0.1367|TWO_SIDED|95.0|-0.244|2.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.693|-0.244|0.1367
91551441|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.101||||0.0294|TWO_SIDED|95.0|0.111|2.091|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.091|0.111|0.0294
91551442|NCT04800211|182986299|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.248||||0.6792|TWO_SIDED|95.0|-1.424|0.928|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.928|-1.424|0.6792
91551443|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.638||||0.4012|TWO_SIDED|95.0|-0.86|2.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.137|-0.860|0.4012
91767070|NCT00796666|183423328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-3.13|1.2|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||1.20|-3.13|
91767071|NCT00796666|183423328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|0.31|4.36|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||4.36|0.31|
91767072|NCT00796666|183423328|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0094
91767073|NCT00796666|183423329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-3.92|1.2|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||1.20|-3.92|
91551444|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.163||||0.0201|TWO_SIDED|95.0|0.343|3.983|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.983|0.343|0.0201
91551445|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.21||||0.1709|TWO_SIDED|95.0|-0.528|2.948|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.948|-0.528|0.1709
91551446|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.593||||0.0307|TWO_SIDED|95.0|0.15|3.035|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.035|0.150|0.0307
91767074|NCT00796666|183423329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-0.38|4.35|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||4.35|-0.38|
91767075|NCT00796666|183423329|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0244
91767076|NCT00796666|183423330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-3.78|2.04|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||2.04|-3.78|
91767077|NCT00796666|183423330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-0.41|4.9|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||4.90|-0.41|
91767078|NCT00796666|183423330|SUPERIORITY_OR_OTHER|||||||0.0624|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0624
91767079|NCT00796666|183423331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-2.57|2.06|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FCvas fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||2.06|-2.57|
91767080|NCT00796666|183423331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|0.48|4.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||4.82|0.48|
91767081|NCT00796666|183423331|SUPERIORITY_OR_OTHER|||||||0.0324|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0324
91767082|NCT00796666|183423332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-2.1|2.97|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||2.97|-2.10|
91767083|NCT00796666|183423332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|1.74|6.45|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||6.45|1.74|
91551447|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.588||||0.0691|TWO_SIDED|95.0|-0.126|3.302|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.302|-0.126|0.0691
91551448|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.487||||0.0034|TWO_SIDED|95.0|0.838|4.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.137|0.838|0.0034
91551449|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.849||||0.0034|TWO_SIDED|95.0|0.622|3.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.075|0.622|0.0034
91767084|NCT00796666|183423332|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0136
91767085|NCT00796666|183423333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-2.33|3.23|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||3.23|-2.33|
91767086|NCT00796666|183423333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|0.14|5.32|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||5.32|0.14|
91767087|NCT00796666|183423333|SUPERIORITY_OR_OTHER|||||||0.1582|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.1582
91767088|NCT00796666|183423334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|-3.09|3.18|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||3.18|-3.09|
91767089|NCT00796666|183423334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-0.62|5.16|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||5.16|-0.62|
91551450|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.178||||0.8123|TWO_SIDED|95.0|-1.654|1.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.299|-1.654|0.8123
91551451|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.48||||0.5879|TWO_SIDED|95.0|-2.226|1.267|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.267|-2.226|0.5879
91551452|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.596||||0.491|TWO_SIDED|95.0|-2.304|1.111|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.111|-2.304|0.4910
91551453|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.816||||0.9673|TWO_SIDED|95.0|-1.967|3.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.599|-1.967|0.9673
91551454|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.643||||0.1787|TWO_SIDED|95.0|-0.683|5.968|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.968|-0.683|0.1787
91767090|NCT00796666|183423334|SUPERIORITY_OR_OTHER|||||||0.2161|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2161
91767091|NCT00796666|183423335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|-1.61|4.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||4.50|-1.61|
91551455|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.806||||0.5243|TWO_SIDED|95.0|-1.406|5.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.018|-1.406|0.5243
91551456|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.77||||0.3956|TWO_SIDED|95.0|-0.966|4.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.507|-0.966|0.3956
91551457|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.068||||0.381|TWO_SIDED|95.0|-1.16|5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.295|-1.160|0.3810
91551458|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.084||||0.0557|TWO_SIDED|95.0|-0.049|6.216|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||6.216|-0.049|0.0557
91767092|NCT00796666|183423335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.82|6.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||6.50|0.82|
91767093|NCT00796666|183423335|SUPERIORITY_OR_OTHER|||||||0.2087|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2087
91767094|NCT00796666|183423336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|-1.21|3.58|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||3.58|-1.21|
91767095|NCT00796666|183423336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|0.37|5.05|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||5.05|0.37|
91551459|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.445||||0.0195|TWO_SIDED|95.0|0.4|4.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.490|0.400|0.0195
91551460|NCT04800211|182986300|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.277||||0.2817|TWO_SIDED|95.0|-3.615|1.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.060|-3.615|0.2817
91551461|NCT05170841|182986301|SUPERIORITY||||||=|0.566|||||||t-test, 2 sided|||||||=0.566
91551462|NCT05170841|182986302|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
91551463|NCT05170841|182986303|SUPERIORITY||||||=|0.006|||||||t-test, 2 sided|||||||=0.006
91551464|NCT05170841|182986304|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
91551465|NCT05170841|182986305|SUPERIORITY||||||=|0.031|||||||t-test, 2 sided|||||||=0.031
91551466|NCT05170841|182986306|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
91551467|NCT05170841|182986307|SUPERIORITY||||||=|0.011|||||||t-test, 2 sided|||||||=0.011
91551468|NCT05170841|182986308|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||||||=0.007
91551469|NCT05170841|182986309|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
91551470|NCT05170841|182986310|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
91551471|NCT05170841|182986311|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||||||=0.022
91551472|NCT05170841|182986312|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91551473|NCT05170841|182986313|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91551474|NCT05170841|182986314|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
91551475|NCT05170841|182986315|SUPERIORITY||||||=|0.01|||||||t-test, 2 sided|||||||=0.01
91551476|NCT05170841|182986316|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||||||=0.04
91551477|NCT05170841|182986317|SUPERIORITY||||||=|0.016|||||||t-test, 2 sided|||||||=0.016
91551478|NCT05170841|182986318|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
91551479|NCT05170841|182986319|SUPERIORITY||||||=|0.042|||||||t-test, 2 sided|||||||=0.042
91551480|NCT05170841|182986320|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||||||=0.037
91551481|NCT05170841|182986321|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
91551482|NCT05170841|182986322|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
91551483|NCT05170841|182986323|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
91551484|NCT05170841|182986324|SUPERIORITY||||||=|0.035|||||||t-test, 2 sided|||||||=0.035
91551485|NCT05170841|182986325|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
91551486|NCT03643744|182986327|SUPERIORITY|||||||0.53|||||||ANOVA|||||||0.530
91551487|NCT03643744|182986327|SUPERIORITY|||||||0.727|||||||ANOVA|||||||0.727
91551488|NCT03643744|182986328|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91551489|NCT04487860|182986330|SUPERIORITY|||||||0.7905|||||||ANCOVA|||||||0.7905
91551490|NCT04487860|182986330|SUPERIORITY|||||||0.7372|||||||ANCOVA|||||||0.7372
91551491|NCT04487860|182986330|SUPERIORITY|||||||0.2989|||||||ANCOVA|||||||0.2989
91551492|NCT04487860|182986330|SUPERIORITY|||||||0.3328|||||||ANCOVA|||||||0.3328
91551493|NCT04487860|182986331|SUPERIORITY|||||||0.8989|||||||ANCOVA|||||||0.8989
91551494|NCT04487860|182986331|SUPERIORITY|||||||0.6768|||||||ANCOVA|||||||0.6768
91551495|NCT04487860|182986331|SUPERIORITY|||||||0.8209|||||||ANCOVA|||||||0.8209
91767096|NCT00796666|183423336|SUPERIORITY_OR_OTHER|||||||0.2897|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2897
91767097|NCT00796666|183423337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.05|1.38|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||1.38|-2.05|
91551496|NCT04487860|182986331|SUPERIORITY|||||||0.3106|||||||ANCOVA|||||||0.3106
91767098|NCT00796666|183423337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|0.46|3.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||3.82|0.46|
91551497|NCT04487860|182986332|SUPERIORITY|||||||0.8593|||||||ANCOVA|||||||0.8593
91551498|NCT04487860|182986332|SUPERIORITY|||||||0.9594|||||||ANCOVA|||||||0.9594
91551499|NCT04487860|182986332|SUPERIORITY|||||||0.9041|||||||ANCOVA|||||||0.9041
91551500|NCT04487860|182986332|SUPERIORITY|||||||0.7147|||||||ANCOVA|||||||0.7147
91551501|NCT06201559|182986378|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for Cmax following replicate administrations of the comparator product was \> 30%, the acceptance criteria for Cmax was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|98.1|||||TWO_SIDED|90.0|86.79|110.91|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||110.91|86.79|
91551502|NCT06201559|182986379|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for AUC(0-t) following replicate administrations of the comparator product was \> 30%, the acceptance criteria for AUC(0-t) was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|97.6|||||TWO_SIDED|90.0|86.86|109.73|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||109.73|86.86|
91551503|NCT02432261|182986394|SUPERIORITY|We did not statistically power this study.|difference of proportion of subjects|57.6||||0.003|TWO_SIDED||||||Fisher Exact||The difference of proportion = NES/Testosterone - Testosterone|||||0.003
91551504|NCT06122194|182986446|OTHER||Ratio of Adjusted Geometric Means|112.15|||||TWO_SIDED|90.0|93.01|135.22||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90 percent (%) confidence intervals (CIs) were expressed as percentages.||135.22|93.01|
91551505|NCT06122194|182986446|OTHER||Ratio of Adjusted Geometric Means|187.37|||||TWO_SIDED|90.0|155.79|225.35||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||225.35|155.79|
91551506|NCT06122194|182986446|OTHER||Ratio of Adjusted Geometric Means|153.61|||||TWO_SIDED|90.0|127.4|185.21||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||185.21|127.40|
91551507|NCT06122194|182986447|OTHER||Ratio of Adjusted Geometric Means|102.59|||||TWO_SIDED|90.0|91.09|115.54||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||115.54|91.09|
91551508|NCT06122194|182986447|OTHER||Ratio of Adjusted Geometric Means|125.07|||||TWO_SIDED|90.0|110.81|141.17||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||141.17|110.81|
91551509|NCT06122194|182986447|OTHER||Ratio of Adjusted Geometric Means|121.75|||||TWO_SIDED|90.0|108.65|136.43||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||136.43|108.65|
91551510|NCT05218096|182986452|OTHER|Difference|Difference|-7.1||||0.6797|TWO_SIDED|90.0|-28.8|15.0|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||15.0|-28.8|0.6797
91551511|NCT05218096|182986452|OTHER|Difference|Difference|-7.1||||0.7341|TWO_SIDED|90.0|-34.8|19.3|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||19.3|-34.8|0.7341
91767099|NCT00796666|183423337|SUPERIORITY_OR_OTHER|||||||0.0179|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0179
91767100|NCT03367858|183423380|SUPERIORITY|||||||0.0173||||||At 12 month follow up.|ANCOVA|||We conducted a repeated measures ANCOVA of Time (Post-Treatment: 3, 6, 12 months) × Treatment (MI, BAM) with the covariate of pre-treatment problem drinking.||||.0173
91767101|NCT02485561|183423408|SUPERIORITY||F-value|1.019||||0.362|TWO_SIDED||||||ANOVA|||||||.362
91767102|NCT02485561|183423409|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.098||0.024|TWO_SIDED||||||t-test, 2 sided|||||||.024
91551512|NCT04726371|182986462|SUPERIORITY|||||||0.89||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of infections over follow-up.|Test of joint null hypothesis from model|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A Poisson GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline infection incidence, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and for intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||0.89
91551513|NCT04726371|182986463|SUPERIORITY||||||>|0.99||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of scores over follow-up.|Wald test|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline fidelity score, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||>.99
91551514|NCT04726371|182986464|SUPERIORITY||Hazard Ratio (HR)|1.21|||>|0.99|TWO_SIDED|95.0|0.79|1.84||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the combined population of residents with SMI and ID/DD. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.84|0.79|>.99
91551515|NCT04726371|182986465|SUPERIORITY||Hazard Ratio (HR)|0.99|||>|0.99|TWO_SIDED|95.0|0.86|1.15||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the staff population. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.15|0.86|>.99
91551516|NCT03125070|182986474|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.90
91551517|NCT03125070|182986475|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.60
91551518|NCT03125070|182986476|OTHER|||||||0.27||||||The threshold for statistical significance was p=0.05|Chi-squared|||Sex: Female vs. Male||||0.27
91551519|NCT03125070|182986476|OTHER|||||||0.88||||||The threshold for statistical significance was p=0.05|Chi-squared|||Age \<70 vs. \>=70||||0.88
91551520|NCT03125070|182986476|OTHER|||||||0.98||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Race and ethnicity: white AND non-Hispanic versus any other combination of race and ethnicity (BIPOC)||||0.98
91551521|NCT03125070|182986476|OTHER|||||||0.19||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Education: High school or less versus at least some college or vocational/technical program||||0.19
91551522|NCT03125070|182986476|OTHER|||||||0.24||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Income: \<$100,000 annual versus \>=$100,000 annual||||0.24
91551523|NCT03125070|182986476|OTHER|||||||0.28||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||PHQ score at baseline: no depression (\<10), mild depression (10-14), moderate depression (15-19), severe depression (\>=20)||||0.28
91551524|NCT03125070|182986476|OTHER|||||||0.33||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||CTXD score at baseline \<0.9 (not distressed) or \>=0.9 (distressed)||||0.33
91551525|NCT03125070|182986476|OTHER|||||||0.1||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Cardiometabolic Healthcare Utilization (HCU-C) score at baseline: \>.80 versus \<.80||||0.10
91551526|NCT03125070|182986476|OTHER|||||||0.31||||||The threshold for statistical significance was p=0.05|Chi-squared|||Secondary cancer screening healthcare utilization (HCU-SM) at baseline: \>=.80 versus \<.80||||0.31
91551527|NCT03125070|182986477|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
91551528|NCT03125070|182986478|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
91551529|NCT04119843|182986580|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.824|<|0.001|TWO_SIDED|95.0|0.743|1.165|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.165|0.743|<0.001
91551530|NCT04119843|182986580|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|0.892|<|0.001|TWO_SIDED|95.0|0.552|1.043|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.043|0.552|<0.001
91551531|NCT04119843|182986580|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|0.622|<|0.001|TWO_SIDED|95.0|0.494|0.813|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.813|0.494|<0.001
91551532|NCT04119843|182986581|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.98|STANDARD_DEVIATION|0.853|<|0.001|TWO_SIDED|95.0|0.759|1.196|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.196|0.759|<0.001
91767103|NCT02485561|183423409|SUPERIORITY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.074||0.75|TWO_SIDED||||||t-test, 2 sided|||||||.75
91767104|NCT02485561|183423410|SUPERIORITY||F-value|6.482||||0.002|TWO_SIDED||||||ANOVA|||||||.002
91767105|NCT02485561|183423410|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.91|TWO_SIDED||||||t-test, 2 sided|||||||.91
91767106|NCT02485561|183423410|SUPERIORITY||Mean Difference (Final Values)|0.716|STANDARD_ERROR_OF_MEAN|0.182|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
91767107|NCT02485561|183423411|SUPERIORITY||F-value|0.608||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
91767108|NCT02485561|183423412|SUPERIORITY||F-value|16.31|||<|0.001|TWO_SIDED||||||ANOVA|||||||<.001
91767109|NCT02485561|183423412|SUPERIORITY||F-value|2.0||||0.14|TWO_SIDED||||||ANOVA|||||||0.14
91767110|NCT02485561|183423413|SUPERIORITY||F-value|1.68||||0.19|TWO_SIDED||||||ANOVA|||||||.19
91767111|NCT02485561|183423413|SUPERIORITY||F-value|0.021||||0.98|TWO_SIDED||||||ANOVA|||||||.98
91767112|NCT02485561|183423413|SUPERIORITY||F-value|0.312||||0.73|TWO_SIDED||||||ANOVA|||||||.73
91767113|NCT02485561|183423413|SUPERIORITY||F-value|0.702||||0.496|TWO_SIDED||||||ANOVA|||||||.496
91767114|NCT02485561|183423413|SUPERIORITY||F-value|1.88||||0.154|TWO_SIDED||||||ANOVA|||||||.154
91767115|NCT02485561|183423413|SUPERIORITY||F-value|0.667||||0.514|TWO_SIDED||||||ANOVA|||||||.514
91767116|NCT02485561|183423413|SUPERIORITY||F-value|0.666||||0.514|TWO_SIDED||||||ANOVA|||||||.514
91767117|NCT02485561|183423414|SUPERIORITY||F-value|0.59||||0.56|TWO_SIDED||||||ANOVA|||||||.56
91767118|NCT02485561|183423415|SUPERIORITY||F-value|0.18||||0.84|TWO_SIDED||||||ANOVA|||||||.84
91767119|NCT02485561|183423416|SUPERIORITY||F-value|1.16||||0.31|TWO_SIDED||||||ANOVA|||||||.31
91551533|NCT04119843|182986581|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.909|<|0.001|TWO_SIDED|95.0|0.766|1.267|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.267|0.766|<0.001
91551534|NCT04119843|182986581|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.678|<|0.001|TWO_SIDED|95.0|0.638|0.985|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.985|0.638|<0.001
91551535|NCT04119843|182986583|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.805|<|0.001|TWO_SIDED|95.0|0.555|0.971|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||0.971|0.555|<0.001
91551536|NCT04119843|182986583|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|1.059|<|0.001|TWO_SIDED|95.0|0.464|1.054|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.054|0.464|<0.001
91551537|NCT04119843|182986583|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|0.609|<|0.001|TWO_SIDED|95.0|0.429|0.747|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.747|0.429|<0.001
91551538|NCT04119843|182986584|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.852|<|0.001|TWO_SIDED|95.0|0.726|1.166|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||1.166|0.726|<0.001
91551539|NCT04119843|182986584|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|1.261|<|0.001|TWO_SIDED|95.0|0.38|1.082|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.082|0.380|<0.001
91551540|NCT04119843|182986584|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.786|<|0.001|TWO_SIDED|95.0|0.517|0.927|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.927|0.517|<0.001
91551541|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|-1.29||||0.27|TWO_SIDED|95.0|-3.6|1.03|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||1.03|-3.60|0.27
91551542|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|-0.25||||0.83|TWO_SIDED|95.0|-2.53|2.04|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||2.04|-2.53|0.83
91551543|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|-2.01||||0.08|TWO_SIDED|95.0|-4.3|0.28|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.28|-4.30|0.08
91551544|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|-1.56||||0.16|TWO_SIDED|95.0|-3.77|0.65|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.65|-3.77|0.16
91551545|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|-1.65||||0.14|TWO_SIDED|95.0|-3.84|0.54|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.54|-3.84|0.14
91551546|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|-2.46||||0.04|TWO_SIDED|95.0|-4.47|-0.17|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||-0.17|-4.47|0.04
91551547|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|2.46||||0.04|TWO_SIDED|95.0|0.17|4.74|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.74|0.17|0.04
91551548|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|1.17||||0.32|TWO_SIDED|95.0|-1.14|3.48|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.48|-1.14|0.32
91551549|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|2.21||||0.06|TWO_SIDED|95.0|-0.08|4.5|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.50|-0.08|0.06
91551550|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|0.45||||0.7|TWO_SIDED|95.0|-1.84|2.73|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||2.73|-1.84|0.70
91551551|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|0.9||||0.42|TWO_SIDED|95.0|-1.31|3.1|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.10|-1.31|0.42
91551552|NCT01037881|182986614|SUPERIORITY||Difference in least squares mean|0.81||||0.47|TWO_SIDED|95.0|-1.38|3.0|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.00|-1.38|0.47
91551553|NCT04563546|182986635|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
91551554|NCT04563546|182986636|OTHER|||||||0.739|||||||Chi-squared|||||||0.739
91551555|NCT04563546|182986637|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
91551556|NCT04005794|182986766|OTHER|||||||0.004||||||Social latency t = 3.215|t-test, 2 sided|||||||0.004
91551557|NCT04005794|182986767|OTHER|||||||0.213|||||||ANOVA|||||||0.213
91551558|NCT04005794|182986768|OTHER|||||||0.01|||||||ANOVA|||||||0.01
91551559|NCT04005794|182986769|OTHER|||||||0.004|||||||ANOVA|||||||0.004
91551560|NCT04005794|182986770|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91551561|NCT05622812|182986775|SUPERIORITY||Treatment difference|39.0|||<|0.001|TWO_SIDED|95.0|21.6|56.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||56.5|21.6|<0.001
91551562|NCT05622812|182986776|SUPERIORITY||Treatment difference|40.4|||<|0.001|TWO_SIDED|95.0|23.1|57.6||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||57.6|23.1|<0.001
91551563|NCT05622812|182986776|SUPERIORITY||Treatment difference|41.7|||<|0.001|TWO_SIDED|95.0|25.6|57.8||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||57.8|25.6|<0.001
91551564|NCT05622812|182986776|SUPERIORITY||Treatment difference|30.2||||0.003|TWO_SIDED|95.0|13.2|47.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||47.1|13.2|0.003
91551565|NCT05622812|182986777|SUPERIORITY||Treatment difference|99.0|||<|0.001|TWO_SIDED|95.0|97.1|100.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||100.0|97.1|<0.001
91551566|NCT05622812|182986777|SUPERIORITY||Treatment difference|87.6|||<|0.001|TWO_SIDED|95.0|76.9|98.2||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||98.2|76.9|<0.001
91551567|NCT05622812|182986777|SUPERIORITY||Treatment difference|80.5|||<|0.001|TWO_SIDED|95.0|68.6|92.4||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||92.4|68.6|<0.001
91551568|NCT05622812|182986777|SUPERIORITY||Treatment difference|73.7|||<|0.001|TWO_SIDED|95.0|61.9|85.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||85.5|61.9|<0.001
91551569|NCT05622812|182986778|SUPERIORITY||Treatment difference|93.1|||<|0.001|TWO_SIDED|95.0|88.2|98.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||98.0|88.2|<0.001
91551570|NCT05622812|182986778|SUPERIORITY||Treatment difference|87.9|||<|0.001|TWO_SIDED|95.0|81.4|94.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||94.3|81.4|<0.001
91551571|NCT05622812|182986778|SUPERIORITY||Treatment difference|80.4|||<|0.001|TWO_SIDED|95.0|72.7|88.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||88.1|72.7|<0.001
91551572|NCT05622812|182986778|SUPERIORITY||Treatment difference|71.6|||<|0.001|TWO_SIDED|95.0|62.8|80.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||80.3|62.8|<0.001
91551573|NCT03916185|182986779|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-32.0|32.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||32|-32|>0.99
91551574|NCT03916185|182986779|SUPERIORITY||Difference in proportions|-15.0||||0.53|TWO_SIDED|95.0|-46.0|18.0||Statistical significance level of 0.05 used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-46|0.53
91551575|NCT03916185|182986779|SUPERIORITY||Difference in proportions|16.0||||0.66|TWO_SIDED|95.0|-29.0|52.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||52|-29|0.66
91551576|NCT03916185|182986780|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-20.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||20|-20|>0.99
91551577|NCT03916185|182986780|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-25.0|13.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||13|-25|>0.99
91767120|NCT02485561|183423417|SUPERIORITY||F-value|1.17||||0.31|TWO_SIDED||||||ANOVA|||||||.31
91767121|NCT02485561|183423417|SUPERIORITY||F-value|0.056||||0.95|TWO_SIDED||||||ANOVA|||||||.95
91767122|NCT03246789|183423489|SUPERIORITY||Mean Difference (Final Values)|2.15||||0.31|TWO_SIDED|95.0|-2.09|6.39|||t-test, 2 sided|||Week 12||6.39|-2.09|0.31
91551578|NCT03916185|182986780|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-26.0|34.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||34|-26|>0.99
91551579|NCT03916185|182986781|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
91551580|NCT03916185|182986781|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
91551581|NCT03916185|182986781|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-17.0|41.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||41|-17|>0.99
91551582|NCT03916185|182986782|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
91551583|NCT03916185|182986782|SUPERIORITY||Difference in proportions|56.0|||<|0.001|TWO_SIDED|95.0|22.0|79.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Comparison was vaccine arm - placebo.|||79|22|<0.001
91767123|NCT03246789|183423490|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.28|TWO_SIDED|95.0|-4.22|1.28|||t-test, 2 sided|||Domain #1, Week 12||1.28|-4.22|0.28
91767124|NCT03246789|183423490|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.5|TWO_SIDED|95.0|-3.48|1.74|||t-test, 2 sided|||Domain #2, Week 12||1.74|-3.48|0.50
91767125|NCT03246789|183423490|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.02|TWO_SIDED|95.0|-2.88|-0.28|||t-test, 2 sided|||Domain #3, Week 12||-0.28|-2.88|0.02
91767126|NCT03246789|183423490|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.98|TWO_SIDED|95.0|-3.63|3.53|||t-test, 2 sided|||Domain 4, Week 12||3.53|-3.63|0.98
91767127|NCT03246789|183423491|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.92|TWO_SIDED|95.0|-0.64|0.58|||t-test, 2 sided|||Domain #1, Week 12||0.58|-0.64|0.92
91767128|NCT03246789|183423491|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|95.0|-0.69|0.33|||t-test, 2 sided|||Domain #2, Week 12||0.33|-0.69|0.48
91767129|NCT03246789|183423491|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.69|||t-test, 2 sided|||||0.69|-0.33|0.48
91767130|NCT00101686|183423502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.433||||0.0152||95.0|1.09|1.89||p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.|Log Rank||Hazard ratio \[mIRI:FOLFIRI\] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (\<=70 vs \>70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.|||1.89|1.09|0.0152
91551584|NCT03916185|182986782|SUPERIORITY||Difference in proportions|56.0||||0.011|TWO_SIDED|95.0|9.0|86.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments were made for multiple comparisons.|Comparison was vaccine arm - placebo.|||86|9|0.011
91551585|NCT03916185|182986782|SUPERIORITY||Difference in proportions|6.0|||>|0.99|TWO_SIDED|95.0|-25.0|36.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||36|-25|>0.99
91551586|NCT03916185|182986782|SUPERIORITY||Difference in proportions|5.0|||>|0.99|TWO_SIDED|95.0|-31.0|48.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||48|-31|>0.99
91551587|NCT03916185|182986782|SUPERIORITY||Difference in proportions|-1.0|||>|0.99|TWO_SIDED|95.0|-38.0|44.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||44|-38|>0.99
91551588|NCT03916185|182986783|SUPERIORITY||Difference in proportions|73.0|||<|0.001|TWO_SIDED|95.0|44.0|91.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||91|44|<0.001
91551589|NCT03916185|182986783|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
91767131|NCT00101686|183423503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.512||||0.0042||95.0|1.16|1.97|||Log Rank|||||1.97|1.16|0.0042
91767132|NCT00101686|183423503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.368||||0.0156||95.0|1.04|1.8|||Log Rank|||||1.80|1.04|0.0156
91551590|NCT03916185|182986783|SUPERIORITY||Difference in proportions|85.0|||<|0.001|TWO_SIDED|95.0|42.0|97.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||97|42|<0.001
91551591|NCT03916185|182986783|SUPERIORITY||Difference in proportions|12.0||||0.66|TWO_SIDED|95.0|-17.0|40.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||40|-17|0.66
91551592|NCT03916185|182986783|SUPERIORITY||Difference in proportions|-12.0|||>|0.99|TWO_SIDED|95.0|-36.0|30.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||30|-36|>0.99
91551593|NCT03916185|182986783|SUPERIORITY||Difference in proportions|-24.0||||0.28|TWO_SIDED|95.0|-50.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||20|-50|0.28
91551594|NCT03916185|182986784|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91551595|NCT03916185|182986784|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91551596|NCT03916185|182986784|SUPERIORITY||||||<|0.001||||||Statistical significance of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91551597|NCT03916185|182986784|SUPERIORITY|||||||0.95||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.95
91551598|NCT03916185|182986784|SUPERIORITY|||||||0.12||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.12
91551599|NCT03916185|182986784|SUPERIORITY|||||||0.033||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.033
91551600|NCT03916185|182986785|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91551601|NCT03916185|182986785|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91551602|NCT03916185|182986785|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
91551603|NCT03916185|182986785|SUPERIORITY|||||||0.39||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.39
91551604|NCT03916185|182986785|SUPERIORITY|||||||0.15||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.15
91767133|NCT00101686|183423503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.4659||95.0|0.81|1.38|||Log Rank|||||1.38|0.81|0.4659
91767134|NCT00101686|183423504|SUPERIORITY_OR_OTHER||F-distribution method|47.2||||||95.0|38.85|55.71|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||55.71|38.85|
91767135|NCT00101686|183423504|SUPERIORITY_OR_OTHER||F-distribution method|43.3||||||95.0|34.95|51.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||51.86|34.95|
91767136|NCT00101686|183423504|SUPERIORITY_OR_OTHER||F-distribution method|38.6||||||95.0|30.66|47.06|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||47.06|30.66|
91767137|NCT00101686|183423504|SUPERIORITY_OR_OTHER|||||||0.4751|||||||Cochran-Mantel-Haenszel|||||||0.4751
91767138|NCT00101686|183423504|SUPERIORITY_OR_OTHER|||||||0.1591|||||||Cochran-Mantel-Haenszel|||||||0.1591
91767139|NCT00101686|183423504|SUPERIORITY_OR_OTHER|||||||0.4395|||||||Cochran-Mantel-Haenszel|||||||0.4395
91767140|NCT00101686|183423505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.268||||0.0879||95.0|0.96|1.68|||Log Rank|||||1.68|0.96|0.0879
91767141|NCT00101686|183423505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2765||95.0|0.9|1.58|||Log Rank|||||1.58|0.90|0.2765
91551605|NCT03916185|182986785|SUPERIORITY|||||||0.049||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.049
91551606|NCT02844465|182986809|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 5 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Boston Naming Test score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-BNT - BSL-BNT) + δ ≤ 0 Alternate Hypothesis: μ (V-BNT - BSL-BNT) + δ \> 0 Where μ (V-BNT - BSL-BNT) = mean difference in the Boston Naming Test score from baseline to Month 12 post Visualase."||||<0.0001
91551607|NCT02844465|182986810|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 15 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Rey Auditory Verbal Learning Test 5-Trial Total score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ ≤ 0 Alternate Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ \> 0 Where μ (V-RAVLT - BSL-RAVLT) = mean difference in the Rey Auditory Verbal Learning Test 5-Trial Total score from baseline to Month 12 post Visualase."||||<0.0001
91551608|NCT02844465|182986811|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It is hypothesized that the QOLIE-31 score will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) ≤ 0 Alternate Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) \> 0 Where M (V-QOLIE-31 - BSL-QOLIE-31) = sign-test statistic (\[increases-decreases\]/2) in the Quality of Life in Epilepsy inventory from baseline to Month 12 post Visualase."||||<0.0001
91551609|NCT02844465|182986812|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.||||||0.0004|||||||Sign test|||"It is hypothesized that the SF-36 Mental Component Score (MCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) ≤ 0 Alternate Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) \> 0 Where M (V- SF-36-MCS - BSL- SF-36-MCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire MCS from baseline to Month 12 post Visualase."||||0.0004
91767142|NCT00101686|183423505|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.9364||95.0|0.8|1.38|||Log Rank|||||1.38|0.80|0.9364
91767143|NCT00101686|183423507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.7163||95.0|0.86|1.33|||Log Rank|||||1.33|0.86|0.7163
91767144|NCT00101686|183423508|SUPERIORITY_OR_OTHER||F-distribution method|39.4||||||95.0|32.83|46.34|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||46.34|32.83|
91551610|NCT02844465|182986813|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It's hypothesized that the SF-36 Physical Component Score (PCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) ≤ 0 Alternate Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) \> 0 Where M (V-SF-36-PCS - BSL- SF-36-PCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire PCS from baseline to Month 12 post Visualase."||||<0.0001
91767145|NCT00101686|183423508|SUPERIORITY_OR_OTHER||F-distribution method|46.5||||||95.0|39.76|53.42|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||53.42|39.76|
91767146|NCT00101686|183423508|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Cochran-Mantel-Haenszel|||||||0.1559
91551611|NCT02844465|182986814|NON_INFERIORITY|"The hypotheses associated with this endpoint are:~Null Hypothesis: π V - 64% + δ ≤ 0 Alternate Hypothesis: π V - 64% + δ \> 0 Where πV is the proportion of subjects treated with Visualase experiencing no seizures.~An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%."|Proportion of Participants|56.0|||||TWO_SIDED|95.0|46.2|65.8||||||||65.8|46.2|
91767147|NCT00101686|183423509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5316||95.0|0.86|1.36|||Log Rank|||||1.36|0.86|0.5316
91767148|NCT00101686|183423510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.269||||0.2835||95.0|0.75|2.15|||Log Rank|||||2.15|0.75|0.2835
91767149|NCT00101686|183423511|SUPERIORITY_OR_OTHER||F-distribution method|57.9||||||95.0|44.08|70.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||70.86|44.08|
91767150|NCT00101686|183423511|SUPERIORITY_OR_OTHER||F-distribution method|53.3||||||95.0|40.0|66.33|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||66.33|40.00|
91767151|NCT00101686|183423511|SUPERIORITY_OR_OTHER|||||||0.7388|||||||Cochran-Mantel-Haenszel|||||||0.7388
91767152|NCT00101686|183423513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.794||||0.037||95.0|1.12|2.88|||Log Rank|||||2.88|1.12|0.0370
91767153|NCT03101566|183423537|OTHER||||||||||||||||||PFS at 6 months was estimated for this trial using the product-limit method of Kaplan and Meier with 95% confidence intervals calculated using Greenwood's formula. All statistical analyses were completed using the SAS System, v9.4 \[Cary, NC, USA\].|||
91767154|NCT01292187|183423563|SUPERIORITY_OR_OTHER|||||||0.0265|||||||Mixed Models Analysis|||||||0.0265
91767155|NCT01292187|183423564|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||0.0340
91551612|NCT05671653|182986836|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|80.25|98.38||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||98.38|80.25|
91551613|NCT05671653|182986836|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|70.0|||||TWO_SIDED|90.0|55.21|88.76||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||88.76|55.21|
91551614|NCT05671653|182986837|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|57.19|||||TWO_SIDED|90.0|39.27|83.29||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||83.29|39.27|
91551615|NCT05671653|182986837|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|29.68|||||TWO_SIDED|90.0|19.6|44.94||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||44.94|19.60|
91551616|NCT05671653|182986838|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|119.86|||||TWO_SIDED|90.0|108.97|131.85||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||131.85|108.97|
91551617|NCT05671653|182986838|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|185.45|||||TWO_SIDED|90.0|108.0|318.44||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||318.44|108.00|
91551618|NCT05671653|182986839|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|103.17|||||TWO_SIDED|90.0|95.09|111.93||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||111.93|95.09|
91551619|NCT05671653|182986839|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|90.2|||||TWO_SIDED|90.0|60.24|135.06||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||135.06|60.24|
91767156|NCT00113841|183423568|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
91551620|NCT05671653|182986840|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|92.88|||||TWO_SIDED|90.0|79.97|107.87||||||Reference: Cohort 2: Midazolam 2 mg (Period 1). Test: Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3).||107.87|79.97|
91551621|NCT01959607|182986904|OTHER||Geometric LS Mean Ratio|103.5|||||TWO_SIDED|95.0|84.94|126.11|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||126.11|84.94|
91551622|NCT01959607|182986905|OTHER||Geometric LS Mean Ratio|96.34|||||TWO_SIDED|95.0|85.1|109.07|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||109.07|85.10|
91767157|NCT00141102|183423604|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
91767158|NCT00141102|183423605|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
91767159|NCT00141102|183423606|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.4146|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.03|-0.06|0.4146
91551623|NCT02589795|182986960|OTHER|Inequality test|||||>|0.05|||||||Fisher Exact|||The proportions of subjects with primary safety outcomes were compared in a pairwise manner between the three randomised groups, using Fisher's exact tests.||||>0.05
91551624|NCT02589795|182986961|OTHER|Inequality test|||||>|0.05|||||||Kruskal-Wallis|Kruskal-Wallis test with Dunn's correction for multiple comparisons||Kruskal-Wallis test with Dunn's correction for multiple comparisons to compare the levels of antigen-specific serum IgG in the three groups at Week 22.||||>0.05
91551625|NCT03511664|182986996|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|99.2|0.29|0.57|||Log Rank|one-sided stratified log-rank test||||0.57|0.29|< 0.001
91551626|NCT03511664|182986997|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|one-sided stratified log-rank test||Primary OS Analysis||0.74|0.52|<0.001
91551627|NCT03511664|182986997|SUPERIORITY||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification|Final OS analysis||0.81|0.58|
91551628|NCT03511664|182986999|SUPERIORITY||Odds Ratio (OR)|24.99|||<|0.001|TWO_SIDED|95.0|6.05|103.24|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||103.24|6.05|< 0.001
91551629|NCT03511664|182987000|SUPERIORITY||Odds Ratio (OR)|5.79|||<|0.001|TWO_SIDED|95.0|3.18|10.55|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||10.55|3.18|< 0.001
91551630|NCT03511664|182987002|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.62|||Log Rank|Two-sided stratified log-rank test||||0.62|0.40|< 0.001
91551631|NCT03511664|182987003|SUPERIORITY||Cox Proportional Hazard|0.3|||<|0.001|TWO_SIDED|95.0|0.24|0.38|||Log Rank|Two-sided stratified log-rank test||||0.38|0.24|< 0.001
91767160|NCT00141102|183423607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.1132|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.1132
91551632|NCT03511664|182987005|SUPERIORITY||Odds Ratio (OR)|11.19|||<|0.001|TWO_SIDED|95.0|6.3|20.0|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||20.0|6.3|< 0.001
91767161|NCT00141102|183423609|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.0495|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0495
91551633|NCT03511664|182987006|SUPERIORITY||Odds Ratio (OR)|23.6|||<|0.001|TWO_SIDED|95.0|8.6|65.1|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||65.1|8.6|< 0.001
91551634|NCT01928394|182987077|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0309|TWO_SIDED|95.0|1.06|4.26|||Cochran-Mantel-Haenszel|||SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion||4.26|1.06|0.0309
91551635|NCT04299464|182987079|SUPERIORITY||Difference in Adjusted Mean|-0.432||||0.765|TWO_SIDED|80.0|-2.291|1.428|||ANCOVA|||||1.428|-2.291|0.7650
91551636|NCT04299464|182987079|SUPERIORITY||Difference in Adjusted Mean|-0.4444||||0.7517|TWO_SIDED|80.0|-2.25|1.363|||ANCOVA|||||1.363|-2.250|0.7517
91551637|NCT04299464|182987088|SUPERIORITY||Difference in Adjusted Mean|1.741||||0.6082|TWO_SIDED|80.0|-2.631|6.114|||ANCOVA|||||6.114|-2.631|0.6082
91551638|NCT04299464|182987088|SUPERIORITY||Difference in Adjusted Mean|-1.715||||0.6228|TWO_SIDED|80.0|-6.204|2.774|||ANCOVA|||||2.774|-6.204|0.6228
91551639|NCT04299464|182987089|SUPERIORITY||Difference in Adjusted Mean|-2.983||||0.1987|TWO_SIDED|80.0|-5.957|-0.009|||ANCOVA|||||-0.009|-5.957|0.1987
91551640|NCT04299464|182987089|SUPERIORITY||Difference in Adjusted Mean|-4.474||||0.046|TWO_SIDED|80.0|-7.326|-1.622|||ANCOVA|||||-1.622|-7.326|0.0460
91551641|NCT04299464|182987090|SUPERIORITY||Difference in Adjusted Means|1.279||||0.4746|TWO_SIDED|80.0|-1.021|3.578|||ANCOVA|||||3.578|-1.021|0.4746
91551642|NCT04299464|182987090|SUPERIORITY||Difference in Adjusted Means|2.697||||0.1244|TWO_SIDED|80.0|0.453|4.94|||ANCOVA|||||4.940|0.453|0.1244
91551643|NCT05907174|182987094|SUPERIORITY||B|-2.23||||0.023|TWO_SIDED||||||Regression, Linear|||||||0.023
91551644|NCT03916276|182987108|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
91767162|NCT00141102|183423610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.0006|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0006
91767163|NCT00141102|183423611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.36|0.45|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.45|0.36|<0.0001
91767164|NCT00141102|183423612|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.118|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|0.98|1.25|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||1.25|0.98|<0.0001
91767165|NCT00141102|183423613|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.748|||<|0.0001|TWO_SIDED|95.0|1.96|3.84|||Cochran-Mantel-Haenszel|Stratified by history of GD ulceration and by region.||||3.84|1.96|<0.0001
91767166|NCT00141102|183423614|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|3.329|||<|0.0001|TWO_SIDED|95.0|2.156|5.141|||Fisher Exact|||GGT||5.141|2.156|<0.0001
91551645|NCT03916276|182987109|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551646|NCT03916276|182987110|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551647|NCT03916276|182987111|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551648|NCT03916276|182987112|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551649|NCT03916276|182987113|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551650|NCT03916276|182987114|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551651|NCT03916276|182987115|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551652|NCT03916276|182987116|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551653|NCT03916276|182987117|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||<|0.05|||||||ANOVA|||||||<.05
91551654|NCT03916276|182987118|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
91551655|NCT03916276|182987119|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
91767167|NCT00141102|183423614|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|1.509||||0.3809|TWO_SIDED|95.0|0.618|3.684|||Fisher Exact|||AST||3.684|0.618|0.3809
91767168|NCT00141102|183423614|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.089||||0.0264|TWO_SIDED|95.0|1.081|4.038|||Fisher Exact|||ALT||4.038|1.081|0.0264
91551656|NCT03916276|182987120|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551657|NCT03916276|182987121|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551658|NCT03916276|182987122|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551659|NCT03916276|182987123|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551660|NCT03916276|182987124|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91551661|NCT03209973|182987125|OTHER||||||<|0.0001||||||1-sided p-value was based on exact test of BGB-A317 versus historical rate of 0.35|Exact Binomial Test|Comparison with historical control values||||||<0.0001
91551662|NCT05233800|182987138|SUPERIORITY||Mean Difference (Net)|5.83|||<|0.05|TWO_SIDED|95.0|3.84|7.81|||Mixed Models Analysis|||||7.81|3.84|<0.05
91551663|NCT05098158|182987169|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||<0.001
91551664|NCT05098158|182987170|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|5.6||||0.003|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.003
91551665|NCT05098158|182987171|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|3.1||||0.011|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.011
91551666|NCT05098158|182987172|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|1.9||||0.168|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.168
91767169|NCT00141102|183423615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.144|STANDARD_ERROR_OF_MEAN|0.697|<|0.0001|TWO_SIDED|95.0|-11.51|-8.78|||ANCOVA|||GGT||-8.78|-11.51|<0.0001
91767170|NCT00141102|183423615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.391|STANDARD_ERROR_OF_MEAN|0.281|<|0.0001|TWO_SIDED|95.0|-2.94|-1.84|||ANCOVA|||AST||-1.84|-2.94|<0.0001
91767171|NCT00141102|183423615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.364|STANDARD_ERROR_OF_MEAN|0.428|<|0.0001|TWO_SIDED|95.0|-7.2|-5.52|||ANCOVA|||ALT||-5.52|-7.20|<0.0001
91767172|NCT00141102|183423616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.565|STANDARD_ERROR_OF_MEAN|1.366||0.6795|TWO_SIDED|95.0|-2.11|3.24|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.24|-2.11|0.6795
91767173|NCT00141102|183423617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.406|STANDARD_ERROR_OF_MEAN|2.624||0.592|TWO_SIDED|95.0|-6.55|3.74|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.74|-6.55|0.5920
91551667|NCT05098158|182987173|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|1.1||||0.456|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.456
91551668|NCT05098158|182987174|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|0.8||||0.517|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.517
91551669|NCT05098158|182987175|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Net)|3.2||||0.012|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.012
91551670|NCT05098158|182987176|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Net)|0.3||||0.811|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||||||0.811
91767174|NCT00141102|183423618|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.038||0.6819|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.06|-0.09|0.6819
91767175|NCT02756572|183423701|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91767176|NCT02756572|183423702|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91767177|NCT02756572|183423703|OTHER|||||||0.049|||||||Fisher Exact|||||||0.049
91767178|NCT02756572|183423704|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
91767179|NCT03956550|183423718|SUPERIORITY|||||||0.2978|||||||Mixed Models Analysis|||||||0.2978
91767180|NCT03956550|183423718|SUPERIORITY|||||||0.689|||||||Mixed Models Analysis|||||||0.6890
91767181|NCT03956550|183423719|SUPERIORITY|||||||0.1973|||||||Mixed Models Analysis|||||||0.1973
91767182|NCT03956550|183423719|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||0.9420
91767183|NCT03956550|183423720|SUPERIORITY|||||||0.1597|||||||Mixed Models Analysis|||||||0.1597
91767184|NCT03956550|183423720|SUPERIORITY|||||||0.9719|||||||Mixed Models Analysis|||||||0.9719
91767185|NCT03956550|183423721|SUPERIORITY|||||||0.1365|||||||Mixed Models Analysis|||||||0.1365
91767186|NCT03956550|183423721|SUPERIORITY|||||||0.0604|||||||Mixed Models Analysis|||||||0.0604
91551671|NCT05098158|182987177|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|0.1||||0.941|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest dat||||0.941
91551672|NCT05098158|182987178|OTHER|Descriptive statistics to report the percentage of offered telehealth sessions that were attended \[#attended/#offered = % attended\]|percentage|95.8|||||TWO_SIDED|||||||||||||
91767187|NCT03956550|183423722|SUPERIORITY|||||||0.0989|||||||Mixed Models Analysis|||||||0.0989
91767188|NCT03956550|183423722|SUPERIORITY|||||||0.5487|||||||Mixed Models Analysis|||||||0.5487
91767189|NCT03956550|183423723|SUPERIORITY|||||||0.3572|||||||Cochran-Mantel-Haenszel|||||||0.3572
91767190|NCT03956550|183423723|SUPERIORITY|||||||0.5747|||||||Cochran-Mantel-Haenszel|||||||0.5747
91767191|NCT02341235|183423758|SUPERIORITY|||||||0.35|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.35
91767192|NCT02341235|183423759|SUPERIORITY|||||||0.22|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||0.22
91767193|NCT02341235|183423760|SUPERIORITY|||||||0.97|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.97
91767194|NCT02341235|183423761|SUPERIORITY|||||||0.98|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.98
91767195|NCT02341235|183423762|SUPERIORITY|||||||0.83|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.83
91767196|NCT02341235|183423763|SUPERIORITY|||||||0.055|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.055
91767197|NCT02341235|183423764|SUPERIORITY|||||||0.71|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.71
91767198|NCT02341235|183423765|SUPERIORITY|||||||0.33|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.33
91767199|NCT02341235|183423766|SUPERIORITY|||||||0.94|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.94
91767200|NCT02341235|183423767|SUPERIORITY|||||||0.57|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.57
91767201|NCT02341235|183423768|SUPERIORITY|||||||0.3|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.30
91767202|NCT02341235|183423769|SUPERIORITY|||||||0.44|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.44
91767203|NCT02341235|183423770|SUPERIORITY|||||||0.62|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.62
91767204|NCT02341235|183423771|SUPERIORITY|||||||0.7|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.70
91767205|NCT02341235|183423772|SUPERIORITY|||||||0.41|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.41
91767206|NCT02341235|183423773|SUPERIORITY|||||||0.72|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.72
91767207|NCT02341235|183423780|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
91551673|NCT03257410|182987180|SUPERIORITY||Mean Difference (Final Values)|14.828|||||TWO_SIDED|95.0|10.501|19.156|||||Method=ANCOVA|If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is \> 0 then superiority will be demonstrated.||19.156|10.501|
91551674|NCT03257410|182987181|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and Elisio 17H is \> -0.1765 g/dL then non-inferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is \> 0, then superiority may be concluded.|Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.098|0.069|||ANCOVA|||||0.069|-0.098|
91551675|NCT03257410|182987182|OTHER||Mean Difference (Final Values)|19.42|STANDARD_ERROR_OF_MEAN|2.103|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||<0.0001
91551676|NCT03257410|182987182|OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|2.115|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||<0.0001
91551677|NCT03257410|182987183|OTHER||Mean Difference (Final Values)|25.07|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
91767208|NCT02341235|183423782|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.580
91767209|NCT02341235|183423790|SUPERIORITY|||||||0.461|||||||ANCOVA|||||||0.461
91551678|NCT03257410|182987183|OTHER||Mean Difference (Final Values)|23.54|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
91767210|NCT02341235|183423792|SUPERIORITY|||||||0.934|||||||ANCOVA|||||||0.934
91551679|NCT03257410|182987184|OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
91767211|NCT04244253|183423802|SUPERIORITY||Difference of score|-1.1||||0.288|TWO_SIDED|95.0|-3.3|1.0|||Mixed-model repeated measures|MMRM included treatment, visit, treatment-by-visit interaction, baseline, and baseline-by-visit interaction using an unstructured covariance matrix.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||1.0|-3.3|0.288
91767212|NCT04244253|183423803|OTHER||Difference in response rate|5.6||||0.329|TWO_SIDED|95.0|-5.6|16.8|||χ2 test|The MADRS response rate in the OPC-64005 20-mg group and the placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||16.8|-5.6|0.329
91551680|NCT03257410|182987184|OTHER||Mean Difference (Final Values)|15.36|STANDARD_ERROR_OF_MEAN|2.479|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
91551681|NCT03257410|182987185|OTHER||Mean Difference (Final Values)|17.59|STANDARD_ERROR_OF_MEAN|9.583||0.0684|TWO_SIDED||||||MMRM|||Week 4||||0.0684
91551682|NCT03257410|182987185|OTHER||Mean Difference (Final Values)|13.98|STANDARD_ERROR_OF_MEAN|7.937||0.0806|TWO_SIDED||||||MMRM|||Week 24||||0.0806
91551683|NCT03257410|182987190|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.0347|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0347
91551684|NCT03257410|182987190|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.033||0.0036|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.0036
91551685|NCT03257410|182987190|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.129
91551686|NCT03257410|182987190|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.052||0.1149|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.1149
91551687|NCT03257410|182987190|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.044||0.0688|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.0688
91551688|NCT03257410|182987190|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.6097|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.6097
91551689|NCT03257410|182987191|OTHER||Mean Difference (Final Values)|-6.32|STANDARD_ERROR_OF_MEAN|4.336||0.1472|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1472
91551690|NCT03257410|182987191|OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|7.154||0.1207|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1207
91551691|NCT03257410|182987192|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.488||0.9775|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9775
91551692|NCT03257410|182987192|OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|2.905||0.5538|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.5538
91551693|NCT03257410|182987193|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.146||0.11|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.1100
91551694|NCT03257410|182987193|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4607|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.4607
91767213|NCT04244253|183423804|OTHER||Difference of Proportion|1.5||||0.731|TWO_SIDED|95.0|-7.2|10.3|||χ2 test|The MADRS remission rate in the OPC-64005 20-mg group and placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||10.3|-7.2|0.731
91767214|NCT01544920|183423805|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.|Difference in SVR24% in Arm 2 vs. Arm 1|1.7|||||TWO_SIDED|95.0|-3.2|6.5||||||Difference in percentage of participants achieving SVR24||6.5|-3.2|
91767215|NCT01544920|183423806|NON_INFERIORITY_OR_EQUIVALENCE|The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.|Difference in SVR24%|10.3|||||TWO_SIDED|95.0|2.5|18.1||||||||18.1|2.5|
91767216|NCT00411749|183423807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91767217|NCT00411749|183423808|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91767218|NCT00411749|183423809|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91767219|NCT00411749|183423810|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91767220|NCT00411749|183423811|SUPERIORITY_OR_OTHER||Geometric Mean|155.2|||||TWO_SIDED|95.0|126.2|190.9||||||||190.9|126.2|
91551695|NCT03257410|182987194|OTHER||Mean Difference (Final Values)|-0.0787|STANDARD_ERROR_OF_MEAN|0.04454||0.0791|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0791
91551696|NCT03257410|182987194|OTHER||Mean Difference (Final Values)|-0.0027|STANDARD_ERROR_OF_MEAN|0.04302||0.9505|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.9505
91551697|NCT03257410|182987194|OTHER||Mean Difference (Final Values)|-0.0615|STANDARD_ERROR_OF_MEAN|0.04271||0.1521|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1521
91551698|NCT03257410|182987194|OTHER||Mean Difference (Final Values)|0.0538|STANDARD_ERROR_OF_MEAN|0.04652||0.2489|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.2489
91551699|NCT03257410|182987194|OTHER||Mean Difference (Final Values)|-0.0345|STANDARD_ERROR_OF_MEAN|0.05025||0.4936|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.4936
91551700|NCT03257410|182987194|OTHER||Mean Difference (Final Values)|-0.0663|STANDARD_ERROR_OF_MEAN|0.0458||0.1497|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1497
91551701|NCT03257410|182987195|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|2.012||0.9001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9001
91551702|NCT03257410|182987195|OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|2.372||0.3279|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.3279
91551703|NCT03257410|182987196|OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.452||0.6576|TWO_SIDED||||||ANCOVA|||||||0.6576
91551704|NCT03257410|182987197|OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.104||0.0058|TWO_SIDED||||||ANCOVA|||||||0.0058
91551705|NCT03257410|182987198|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.023||0.034|TWO_SIDED||||||ANCOVA|||||||0.034
91767221|NCT00411749|183423811|SUPERIORITY_OR_OTHER||Geometric Mean|198.2|||||TWO_SIDED|95.0|160.9|244.2||||||||244.2|160.9|
91767222|NCT00411749|183423811|SUPERIORITY_OR_OTHER||Geometric Mean|617.1|||||TWO_SIDED|95.0|491.7|774.5||||||||774.5|491.7|
91767223|NCT00411749|183423811|SUPERIORITY_OR_OTHER||Geometric Mean|90.0|||||TWO_SIDED|95.0|68.8|117.8||||||||117.8|68.8|
91551706|NCT03257410|182987199|OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.071||0.0285|TWO_SIDED||||||ANCOVA|||||||0.0285
91551707|NCT03257410|182987200|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.513||0.9069|TWO_SIDED||||||ANCOVA|||||||0.9069
91551708|NCT03257410|182987201|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.443||0.8413|TWO_SIDED||||||ANCOVA|||||||0.8413
91551709|NCT03257410|182987202|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.382||0.0125|TWO_SIDED||||||ANCOVA|||||||0.0125
91551710|NCT03257410|182987203|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.561||0.6891|TWO_SIDED||||||ANCOVA|||||||0.6891
91551711|NCT03257410|182987204|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.047||0.6043|TWO_SIDED||||||ANCOVA|||||||0.6043
91551712|NCT03257410|182987205|OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|2.08||0.5067|TWO_SIDED||||||ANCOVA|||||||0.5067
91551713|NCT03257410|182987206|OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0297|TWO_SIDED||||||ANCOVA|||||||0.0297
91551714|NCT03257410|182987207|OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|2.14||0.1325|TWO_SIDED||||||ANCOVA|||||||0.1325
91551715|NCT03257410|182987208|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2304|TWO_SIDED||||||ANCOVA|||||||0.2304
91551716|NCT03257410|182987209|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.846||0.5785|TWO_SIDED||||||ANCOVA|||||||0.5785
91551717|NCT03257410|182987210|OTHER||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|0.918||0.0067|TWO_SIDED||||||ANCOVA|||||||0.0067
91551718|NCT03257410|182987211|OTHER||Mean Difference (Final Values)|-14.93|STANDARD_ERROR_OF_MEAN|7.314||0.0434|TWO_SIDED||||||ANCOVA|||||||0.0434
91551719|NCT03257410|182987212|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3281|TWO_SIDED||||||ANCOVA|||||||0.3281
91551720|NCT03257410|182987213|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.334||0.0463|TWO_SIDED||||||ANCOVA|||||||0.0463
91551721|NCT03257410|182987214|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1925|TWO_SIDED||||||ANCOVA|||||||0.1925
91551722|NCT03257410|182987215|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.389||0.2569|TWO_SIDED||||||ANCOVA|||||||0.2569
91551723|NCT03257410|182987216|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.104||0.5709|TWO_SIDED||||||ANCOVA|||||||0.5709
91551724|NCT03257410|182987217|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.412||0.217|TWO_SIDED||||||ANCOVA|||||||0.217
91551725|NCT03257410|182987218|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.292||0.2386|TWO_SIDED||||||ANCOVA|||||||0.2386
91551726|NCT03257410|182987219|OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.84||0.1769|TWO_SIDED||||||ANCOVA|||||||0.1769
91551727|NCT03257410|182987220|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8102|TWO_SIDED||||||ANCOVA|||||||0.8102
91551728|NCT03257410|182987221|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.501||0.9672|TWO_SIDED||||||ANCOVA|||||||0.9672
91551729|NCT03257410|182987222|OTHER||Mean Difference (Final Values)|27.34|STANDARD_ERROR_OF_MEAN|24.623||0.2697|TWO_SIDED||||||ANCOVA|||||||0.2697
91551730|NCT03257410|182987225|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.115||0.7189|TWO_SIDED||||||ANCOVA|||||||0.7189
91551731|NCT03257410|182987226|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
91551732|NCT03257410|182987227|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.113||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
91551733|NCT03257410|182987228|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0733|TWO_SIDED||||||ANCOVA|||||||0.0733
91551734|NCT03257410|182987229|OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|5.467||0.5326|TWO_SIDED||||||ANCOVA|||||||0.5326
91767224|NCT03001557|183423820|SUPERIORITY||Least square mean (LSM) difference|3.177||||0.1099|TWO_SIDED|95.0|-0.741|7.096||Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.096|-0.741|0.1099
91767225|NCT03001557|183423820|SUPERIORITY||LSM Difference|2.802||||0.1576|TWO_SIDED|95.0|-1.119|6.723||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.723|-1.119|0.1576
91551735|NCT03257410|182987230|OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.076||0.3042|TWO_SIDED||||||ANCOVA|||||||0.3042
91551736|NCT03257410|182987231|OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.976||0.5534|TWO_SIDED||||||ANCOVA|||||||0.5534
91551737|NCT03257410|182987232|OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.181||0.2958|TWO_SIDED||||||ANCOVA|||||||0.2958
91551738|NCT03257410|182987233|OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0998|TWO_SIDED||||||ANCOVA|||||||0.0998
91767226|NCT03001557|183423820|SUPERIORITY||LSM Difference|-0.96||||0.616|TWO_SIDED|95.0|-4.777|2.857||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.857|-4.777|0.6160
91767227|NCT03001557|183423820|SUPERIORITY||LSM Difference|0.713||||0.7135|TWO_SIDED|95.0|-3.16|4.585||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||4.585|-3.160|0.7135
91767228|NCT03001557|183423824|SUPERIORITY||LSM Difference|-5.098||||0.1582|TWO_SIDED|95.0|-12.24|2.045||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.045|-12.240|0.1582
91767229|NCT03001557|183423824|SUPERIORITY||LSM Difference|-6.105||||0.0961|TWO_SIDED|95.0|-13.332|1.122||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.122|-13.332|0.0961
91767230|NCT03001557|183423824|SUPERIORITY||LSM Difference|0.68||||0.8449|TWO_SIDED|95.0|-6.262|7.623||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.623|-6.262|0.8449
91767231|NCT03001557|183423824|SUPERIORITY||LSM Difference|-3.14||||0.3747|TWO_SIDED|95.0|-10.178|3.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.897|-10.178|0.3747
91767232|NCT03001557|183423828|SUPERIORITY||LSM Difference|1.932||||0.3966|TWO_SIDED|95.0|-2.601|6.465||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.465|-2.601|0.3966
91767233|NCT03001557|183423828|SUPERIORITY||LSM Difference|3.386||||0.1381|TWO_SIDED|95.0|-1.125|7.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.897|-1.125|0.1381
91551739|NCT03257410|182987234|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|3.176||0.9952|TWO_SIDED||||||ANCOVA|||||||0.9952
91551740|NCT03257410|182987235|OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.693||0.3063|TWO_SIDED||||||ANCOVA|||||||0.3063
91767234|NCT03001557|183423828|SUPERIORITY||LSM Difference|1.337||||0.5487|TWO_SIDED|95.0|-3.104|5.778||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||5.778|-3.104|0.5487
91767235|NCT03001557|183423828|SUPERIORITY||LSM Difference|4.32||||0.0581|TWO_SIDED|95.0|-0.153|8.793||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||8.793|-0.153|0.0581
91767236|NCT03001557|183423832|SUPERIORITY||LSM Difference|-3.437||||0.1777|TWO_SIDED|95.0|-8.481|1.608||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.608|-8.481|0.1777
91551741|NCT03257410|182987236|OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.529||0.1098|TWO_SIDED||||||ANCOVA|||||||0.1098
91551742|NCT03257410|182987237|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.797||0.0766|TWO_SIDED||||||ANCOVA|||||||0.0766
91551743|NCT03257410|182987238|OTHER||Mean Difference (Final Values)|-2.58|STANDARD_ERROR_OF_MEAN|2.41||0.2886|TWO_SIDED||||||ANCOVA|||||||0.2886
91551744|NCT03257410|182987239|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.042||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
91551745|NCT03257410|182987240|OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|2.96||0.5992|TWO_SIDED||||||ANCOVA|||||||0.5992
91551746|NCT03257410|182987241|OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.29||0.3836|TWO_SIDED||||||ANCOVA|||||||0.3836
91551747|NCT03257410|182987242|OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|7.284||0.0769|TWO_SIDED||||||ANCOVA|||||||0.0769
91551748|NCT03257410|182987243|OTHER||Mean Difference (Final Values)|-19.56|STANDARD_ERROR_OF_MEAN|5.17||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
91551749|NCT03257410|182987244|OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|1.039||0.1825|TWO_SIDED||||||ANCOVA|||||||0.1825
91551750|NCT03257410|182987245|OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.737||0.0957|TWO_SIDED||||||ANCOVA|||||||0.0957
91551751|NCT03257410|182987246|OTHER||Mean Difference (Final Values)|-34.02|STANDARD_ERROR_OF_MEAN|10.23||0.0012|TWO_SIDED||||||ANCOVA|||||||0.0012
91551752|NCT03257410|182987247|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.859||0.1824|TWO_SIDED||||||ANCOVA|||||||0.1824
91767237|NCT03001557|183423832|SUPERIORITY||LSM Difference|1.458||||0.563|TWO_SIDED|95.0|-3.564|6.479||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.479|-3.564|0.5630
91767238|NCT03001557|183423832|SUPERIORITY||LSM Difference|-4.994||||0.0482|TWO_SIDED|95.0|-9.946|-0.041||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-0.041|-9.946|0.0482
91767239|NCT03001557|183423832|SUPERIORITY||LSM Difference|-2.593||||0.3036|TWO_SIDED|95.0|-7.599|2.413||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.413|-7.599|0.3036
91767240|NCT03001557|183423836|SUPERIORITY||LSM Difference|4.845||||0.1991|TWO_SIDED|95.0|-2.624|12.313||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||12.313|-2.624|0.1991
91767241|NCT03001557|183423836|SUPERIORITY||LSM Difference|-3.872||||0.2982|TWO_SIDED|95.0|-11.263|3.518||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.518|-11.263|0.2982
91767242|NCT03001557|183423836|SUPERIORITY||LSM Difference|6.776||||0.0664|TWO_SIDED|95.0|-0.474|14.025||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||14.025|-0.474|0.0664
91767243|NCT03001557|183423836|SUPERIORITY||LSM Difference|3.017||||0.4148|TWO_SIDED|95.0|-4.344|10.379||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||10.379|-4.344|0.4148
91767244|NCT03001557|183423840|SUPERIORITY||LSM Difference|0.063||||0.9599|TWO_SIDED|95.0|-2.452|2.579||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.579|-2.452|0.9599
91767245|NCT03001557|183423840|SUPERIORITY||LSM Difference|-0.238||||0.8541|TWO_SIDED|95.0|-2.817|2.342||Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.|MMRM|||||2.342|-2.817|0.8541
91767246|NCT03001557|183423840|SUPERIORITY||LSM Difference|-0.293||||0.8117|TWO_SIDED|95.0|-2.745|2.16||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.160|-2.745|0.8117
91767247|NCT03001557|183423840|SUPERIORITY||LSM Difference|-1.557||||0.2274|TWO_SIDED|95.0|-4.113|1.0||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.000|-4.113|0.2274
91767248|NCT03001557|183423844|SUPERIORITY||LSM Difference|0.086||||0.2421|TWO_SIDED|95.0|-0.06|0.232||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.232|-0.060|0.2421
91767249|NCT03001557|183423844|SUPERIORITY||LSM Difference|-0.012||||0.8661|TWO_SIDED|95.0|-0.155|0.131||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.131|-0.155|0.8661
91767250|NCT03001557|183423844|SUPERIORITY||LSM Difference|0.057||||0.4251|TWO_SIDED|95.0|-0.085|0.199||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.199|-0.085|0.4251
91767251|NCT03001557|183423844|SUPERIORITY||LSM Difference|0.025||||0.7248|TWO_SIDED|95.0|-0.116|0.166||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.166|-0.116|0.7248
91767252|NCT03001557|183423848|SUPERIORITY||LSM Difference|-0.032||||0.2991|TWO_SIDED|95.0|-0.094|0.029||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.029|-0.094|0.2991
91767253|NCT03001557|183423848|SUPERIORITY||LSM Difference|0.033||||0.2861|TWO_SIDED|95.0|-0.028|0.095||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.095|-0.028|0.2861
91767254|NCT03001557|183423848|SUPERIORITY||LSM Difference|-0.052||||0.0938|TWO_SIDED|95.0|-0.113|0.009||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.009|-0.113|0.0938
91767255|NCT03001557|183423848|SUPERIORITY||LSM Difference|0.005||||0.8618|TWO_SIDED|95.0|-0.055|0.066||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.066|-0.055|0.8618
91767256|NCT03001557|183423852|SUPERIORITY||LSM Difference|-389.873||||0.0294|TWO_SIDED|95.0|-739.177|-40.569||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-40.569|-739.177|0.0294
91767257|NCT03001557|183423852|SUPERIORITY||LSM Difference|-402.994||||0.0243|TWO_SIDED|95.0|-751.67|-54.319||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-54.319|-751.670|0.0243
91767258|NCT03001557|183423852|SUPERIORITY||LSM Difference|-141.026||||0.4209|TWO_SIDED|95.0|-489.805|207.752||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||207.752|-489.805|0.4209
91767259|NCT03001557|183423852|SUPERIORITY||LSM Difference|-367.845||||0.0398|TWO_SIDED|95.0|-717.87|-17.82||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-17.820|-717.870|0.0398
91767260|NCT03001557|183423856|SUPERIORITY||LSM Difference|-1276.18||||0.1162|TWO_SIDED|95.0|-2878.587|326.226||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||326.226|-2878.587|0.1162
91767261|NCT03001557|183423856|SUPERIORITY||LSM Difference|227.464||||0.7781|TWO_SIDED|95.0|-1382.85|1837.777||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1837.777|-1382.850|0.7781
91767262|NCT03001557|183423856|SUPERIORITY||LSM Difference|-620.581||||0.4255|TWO_SIDED|95.0|-2170.342|929.179||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||929.179|-2170.342|0.4255
91551753|NCT00104676|182987276|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.05|TWO_SIDED|95.0|0.44|1.0|||Log Rank|Adjusted on the stratification factor (treatment centers)||To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.||1.00|0.44|0.05
91551754|NCT00104676|182987277|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.34|TWO_SIDED|95.0|0.46|1.31|||Log Rank|Adjusted on the stratification factor (treatment centers)||||1.31|0.46|0.34
91551755|NCT05196919|182987293|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|8.693||1|TWO_SIDED|95.0|-22.57|30.97|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||30.97|-22.57|1.00
91551756|NCT05196919|182987293|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|8.142||0.99|TWO_SIDED|95.0|-17.12|33.03|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||33.03|-17.12|0.99
91551757|NCT05196919|182987294|SUPERIORITY||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|4.676||0.1933|TWO_SIDED|95.0|-15.49|3.19|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||3.19|-15.49|0.1933
91551758|NCT05196919|182987294|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|4.434||0.2511|TWO_SIDED|95.0|-3.73|14.0|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||14.00|-3.73|0.2511
91551759|NCT03687086|182987306|SUPERIORITY||Odds Ratio (OR)|1.95|STANDARD_ERROR_OF_MEAN|0.63||0.039|TWO_SIDED|95.0|1.03|3.7|||Regression, Logistic|||||3.70|1.03|.039
91551760|NCT03687086|182987307|SUPERIORITY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|0.97||0.155|TWO_SIDED|95.0|-0.52|3.29|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 Weeks vs. baseline)||||3.29|-0.52|0.155
91551761|NCT03687086|182987308|SUPERIORITY||Median Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.04||0.88|TWO_SIDED|95.0|-1.88|2.2|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||2.20|-1.88|0.880
91551762|NCT03687086|182987309|SUPERIORITY||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.228|TWO_SIDED|95.0|-1.25|0.3|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.30|-1.25|0.228
91767263|NCT03001557|183423856|SUPERIORITY||LSM Difference|-577.82||||0.4672|TWO_SIDED|95.0|-2160.337|1004.697||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1004.697|-2160.337|0.4672
91767264|NCT03001557|183423860|SUPERIORITY||LSM Difference|-839.088||||0.2984|TWO_SIDED|95.0|-2440.854|762.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||762.678|-2440.854|0.2984
91551763|NCT03687086|182987310|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.44||0.843|TWO_SIDED|95.0|-0.96|0.78|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.78|-0.96|0.843
91551764|NCT03687086|182987311|SUPERIORITY||Odds Ratio (OR)|3.68|STANDARD_ERROR_OF_MEAN|1.48||0.001|TWO_SIDED|95.0|1.67|8.12|||Regression, Logistic|||||8.12|1.67|0.001
91551765|NCT03687086|182987312|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.42||0.443|TWO_SIDED|95.0|-1.14|0.5|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.50|-1.14|0.443
91767265|NCT03001557|183423860|SUPERIORITY||LSM Difference|651.922||||0.4218|TWO_SIDED|95.0|-962.835|2266.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2266.678|-962.835|0.4218
91551766|NCT03687086|182987313|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.51||0.409|TWO_SIDED|95.0|-1.41|0.58|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.58|-1.41|0.409
91551767|NCT02038777|182987361|OTHER||||||<|0.0001||||||An exact test for a single proportion (1-sided significance level: 0.05) was used.|Exact test for a single proportion|||||||<.0001
91551768|NCT04731129|182987444|SUPERIORITY|||||||0.023||||||threshold for statistical significance \< 0.05|Fisher Exact|||Abnormal tissular architecture||||0.023
91551769|NCT04731129|182987444|SUPERIORITY|||||||0.01||||||Threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell size||||0.01
91551770|NCT04731129|182987444|SUPERIORITY|||||||0.01||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell shape||||0.01
91551771|NCT04731129|182987444|SUPERIORITY|||||||0.013||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell fluorescence||||0.013
91551772|NCT04731129|182987444|SUPERIORITY|||||||0.16||||||threshold for statistical significance \< 0.05|Fisher Exact|||Blood vessel dysplasia||||0.16
91551773|NCT04731129|182987444|SUPERIORITY|||||||0.17||||||threshold for statistical significance \< 0.05|Fisher Exact|||Organized conjunctive fibers||||0.17
91551774|NCT04731129|182987444|SUPERIORITY|||||||0.049||||||threshold for statistical significance \< 0.05|Fisher Exact|||Full chia seed sign||||0.049
91551775|NCT04731129|182987444|SUPERIORITY|||||||0.0041||||||threshold for statistical significance \< 0.05|Fisher Exact|||General physician conclusion||||0.0041
91767266|NCT03001557|183423860|SUPERIORITY||LSM Difference|-447.245||||0.5655|TWO_SIDED|95.0|-1998.44|1103.95||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1103.950|-1998.440|0.5655
91767267|NCT03001557|183423860|SUPERIORITY||LSM Difference|-130.603||||0.8686|TWO_SIDED|95.0|-1706.478|1445.272||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1445.272|-1706.478|0.8686
91551776|NCT03386578|182987456|OTHER||Incidence rate ratio|1.62|||||TWO_SIDED|95.0|0.89|2.94||||||The incidence rate ratio of cumulative maternal adverse events was calculated between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and the PrEP-unexposed (Cohort 2/Step 1) reference group based on incidence per person-time follow-up. Maternal participants in Cohort 2/Step 2 contributed person-time to both Cohort 2/Step 1 and Step 2.||2.94|0.89|
91551777|NCT03386578|182987457|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.52|1.5||||||Odds ratio comparing the proportion of mothers with adverse pregnancy outcomes between the PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group.||1.50|0.52|
91551778|NCT03386578|182987457|OTHER|||||||0.68|||||||Fisher Exact|||Test the differences in the proportion of mothers with adverse pregnancy outcomes between PrEP-exposed (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 2) groups.||||0.68
91551779|NCT03386578|182987458|OTHER||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|0.7|2.38||||||The incidence rate ratio of cumulative infant AEs between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group was based on incidence per person-time follow-up. Cohort 2/Step 2 infants contributed person-time to both Cohort 2/Step 1 and Step 2.||2.38|0.70|
91551780|NCT03386578|182987459|OTHER|||||||0.18|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant whole-body bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.18
91551781|NCT03386578|182987460|OTHER|||||||0.39|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.39
91767268|NCT03001557|183423864|SUPERIORITY||LSM Difference|0.02||||0.4638|TWO_SIDED|95.0|-0.034|0.074||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.074|-0.034|0.4638
91767269|NCT03001557|183423864|SUPERIORITY||LSM Difference|0.06||||0.0322|TWO_SIDED|95.0|0.005|0.115||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.115|0.005|0.0322
91767270|NCT03001557|183423864|SUPERIORITY||LSM Difference|0.003||||0.9144|TWO_SIDED|95.0|-0.051|0.056||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.056|-0.051|0.9144
91551782|NCT03386578|182987461|OTHER|||||||0.12|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.12
91551783|NCT03386578|182987462|OTHER|||||||0.7|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.70
91551784|NCT03386578|182987463|OTHER|||||||0.58|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.58
91551785|NCT03386578|182987464|OTHER|||||||0.08|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.08
91551786|NCT03386578|182987465|OTHER|||||||0.52|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1)||||0.52
91551787|NCT03386578|182987466|OTHER|||||||0.3|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.30
91551788|NCT03386578|182987467|OTHER|||||||0.06|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.06
91551789|NCT03386578|182987468|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91767271|NCT03001557|183423864|SUPERIORITY||LSM Difference|0.057||||0.0364|TWO_SIDED|95.0|0.004|0.11||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction|MMRM|||||0.110|0.004|0.0364
91767272|NCT01272232|183423870|SUPERIORITY_OR_OTHER||Treatment contrast|-3.97|||<|0.0001||95.0|-4.84|-3.11||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-3.11|-4.84|<0.0001
91551790|NCT01868997|182987473|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.001|TWO_SIDED|95.0|3.293|23.825||Odds ratio, 95% confidence interval, and P-value are obtained from a logistic regression model with treatment and smoking status as covariates.|Regression, Logistic|||||23.825|3.293|< 0.001
91551791|NCT01868997|182987474|SUPERIORITY||Difference in Least Squares Mean|10.97|STANDARD_ERROR_OF_MEAN|3.221||0.001|TWO_SIDED|95.0|4.561|17.375|||Mixed-Model Repeated Measures|||||17.375|4.561|0.001
91551792|NCT01868997|182987475|SUPERIORITY||Difference in Least Squares Mean|-2.31|STANDARD_ERROR_OF_MEAN|0.269|<|0.001|TWO_SIDED|95.0|-2.843|-1.772|||Mixed-Model Repeated Measures|||||-1.772|-2.843|< 0.001
91551793|NCT01868997|182987476|SUPERIORITY||Difference in Least Squares Mean|-1.59|STANDARD_ERROR_OF_MEAN|0.245|<|0.001|TWO_SIDED|95.0|-2.073|-1.098|||Mixed-Model Repeated Measures|||||-1.098|-2.073|< 0.001
91551794|NCT01868997|182987477|SUPERIORITY||Difference in Least Squares Mean|14.16|STANDARD_ERROR_OF_MEAN|3.827|<|0.001|TWO_SIDED|95.0|6.549|21.773|||Mixed-Model Repeated Measures|||||21.773|6.549|< 0.001
91551795|NCT01868997|182987478|SUPERIORITY||Difference in Least Squares Mean|6.32|STANDARD_ERROR_OF_MEAN|3.81||0.101|TWO_SIDED|95.0|-1.255|13.901|||Mixed-Model Repeated Measures|||||13.901|-1.255|0.101
91551796|NCT03987022|182987509|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||.16
91551797|NCT03987022|182987510|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91551798|NCT03987022|182987511|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||.01
91551799|NCT03987022|182987512|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91551800|NCT03987022|182987513|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||.58
91551801|NCT03987022|182987514|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
91551802|NCT03987022|182987515|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
91551803|NCT03987022|182987516|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
91551804|NCT03987022|182987517|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91551805|NCT01627574|182987525|SUPERIORITY||Risk Ratio, log|0.281|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|95.0|0.056|1.42|||Chi-squared, Corrected|||||1.42|.056|>.05
91551806|NCT03806790|182987534|SUPERIORITY||Odds Ratio (OR)|5.8||||0.12|TWO_SIDED|95.0|0.68|49.16|||Fisher Exact|||Statistical analysis on the Full Analysis Set (FAS)||49.16|0.68|0.120
91551807|NCT03806790|182987535|SUPERIORITY||Odds Ratio (OR)|2.5||||0.004|TWO_SIDED|95.0|1.36|4.6|||Fisher Exact|||End of Week 1 (FAS)||4.60|1.36|0.004
91551808|NCT03806790|182987535|SUPERIORITY||Odds Ratio (OR)|4.85||||0.003|TWO_SIDED|95.0|1.57|14.97|||Fisher Exact|||End of Week 2 (FAS)||14.97|1.57|0.003
91551809|NCT03806790|182987536|SUPERIORITY||Estimated difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.64|-0.59|||ANOVA|||FAS||-0.59|-1.64|<0.001
91551810|NCT01236781|182987594|EQUIVALENCE|no margin is assumed.||||||0.46||||||1 degree of freedom;|McNemar|Exact test||"To account for the paired nature of the design, McNemar's test will be used to compare the call-back rates.~H0: assumes no difference between the tests (modalities)"||||0.46
91551811|NCT01236781|182987597|EQUIVALENCE|no equivalence margin||||||0.2188||||||Due to the paired nature of the data an exact McNemar's Test is used|McNemar|Exact test||H0: no difference between the 2 modalities||||0.2188
91551812|NCT04028284|182987616|OTHER|Two-sided inferential test||||||0.02||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction. The a priori threshold for statistical significance was P \< 0.05 for the primary outcome.|t-test, 2 sided|||||||0.02
91551813|NCT04028284|182987617|OTHER|Inferential two-sided test||||||0.31|||||||t-test, 2 sided|||||||0.31
91551814|NCT04028284|182987618|OTHER|Inferential two-sided test||||||0.01||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.01
91551815|NCT04028284|182987619|OTHER|Inferential two-sided test||||||0.03||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.03
91551816|NCT04028284|182987620|OTHER|Inferential two-sided test||||||0.56|||||||t-test, 2 sided|||||||0.56
91551817|NCT04028284|182987621|OTHER|Inferential two-sided test||||||0.78|||||||t-test, 2 sided|||||||0.78
91551818|NCT04028284|182987622|OTHER|Inferential two-sided test||||||0.24|||||||Fisher Exact|||||||0.24
91551819|NCT03728608|182987660|SUPERIORITY|||||||0.92|||||||survival analysis|||||||0.92
91551820|NCT03728608|182987661|SUPERIORITY|||||||0.65|||||||survival analysis|||||||0.65
91551821|NCT03728608|182987662|SUPERIORITY|||||||0.96|||||||survival analysis|||||||0.96
91551822|NCT03728608|182987663|SUPERIORITY|||||||0.77|||||||survival analysis|||||||0.77
91551823|NCT03728608|182987664|SUPERIORITY|||||||0.43|||||||Regression, Logistic|||||||0.43
91551824|NCT03728608|182987665|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
91551825|NCT03728608|182987666|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
91551826|NCT03728608|182987667|SUPERIORITY|||||||0.79|||||||Regression, Logistic|||||||0.79
91551827|NCT04587453|182987683|OTHER|No formal testing was performed. Confidence intervals (CIs) are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-11.2|22.5|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||22.5|-11.2|
91551828|NCT04587453|182987684|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-2.9|33.0|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Subjects with 75% reduction in EASI were considered responders. Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||33.0|-2.9|
91551829|NCT04587453|182987685|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-5.1|||||TWO_SIDED|95.0|-12.4|2.3|||||Analysis of covariance (ANCOVA). Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||2.3|-12.4|
91551830|NCT04587453|182987686|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.7|0.5|||||ANCOVA. Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||0.5|-2.7|
91551831|NCT04587453|182987687|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|-3.8|||||TWO_SIDED|95.0|-21.7|14.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least a reduction of 4 in the worst daily pruritus NRS score were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data at Week 16 were imputed as non-responders.||14.2|-21.7|
91551832|NCT04587453|182987688|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-3.0|33.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with a reduction of 90% in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||33.2|-3.0|
91767273|NCT01272232|183423870|SUPERIORITY_OR_OTHER||Treatment contrast|-2.62|||<|0.0001||95.0|-3.63|-1.62||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.62|-3.63|<0.0001
91767274|NCT01272232|183423870|SUPERIORITY_OR_OTHER||Treatment contrast|-1.35||||0.0024||95.0|-2.23|-0.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.48|-2.23|0.0024
91767275|NCT01272232|183423871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.81|||<|0.0001||95.0|4.34|10.68||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||10.68|4.34|<0.0001
91767276|NCT01272232|183423871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69|||<|0.0001||95.0|2.24|6.09||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||6.09|2.24|<0.0001
91767277|NCT01272232|183423871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0008||95.0|1.29|2.64||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.64|1.29|0.0008
91767278|NCT01272232|183423872|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.0001||95.0|3.48|14.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||14.48|3.48|<0.0001
91551833|NCT04587453|182987689|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-9.0|20.3|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least 50% reduction in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||20.3|-9.0|
91551834|NCT04587453|182987690|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-14.9|6.3|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||6.3|-14.9|
91551835|NCT04587453|182987691|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||0.8|-0.7|
91551836|NCT04587453|182987692|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.9|0.6|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 1 change imputed as 0 if no post-baseline assessments.|||0.6|-0.9|
91551837|NCT04587453|182987693|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.6|-0.9|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||-0.9|-5.6|
91551838|NCT04231331|182987756|SUPERIORITY||||||<|0.001||||||P-value \<0.05 was considered statistically significant.|t-test, 2 sided|||Based on our previous study, we assumed a common baseline mean EROA of 0.21 cm2 with a common standard deviation of 0.11 cm2. Given these assumptions, we calculated that a sample size of 204 patients randomly assigned to two groups, would provide 90% power to detect a difference of 0.05 cm2 in the EROA between the ertugliflozin and placebo groups, using a two-sided t test with an alpha level of 0.05.||||<0.001
91551839|NCT03526887|182987793|SUPERIORITY||Median Difference (Net)|9.7||||0.016|TWO_SIDED|95.0|9.4|19.1|||Log Rank|||||19.1|9.4|0.016
91551840|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|2.49||||0.75|TWO_SIDED|90.0|-10.66|15.65|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||15.65|-10.66|0.75
91551841|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-5.37||||0.5|TWO_SIDED|90.0|-18.49|7.76|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||7.76|-18.49|0.50
91551842|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.83|TWO_SIDED|90.0|-11.48|14.84|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||14.84|-11.48|0.83
91551843|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.84|TWO_SIDED|90.0|-7.91|6.15|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||6.15|-7.91|0.84
91551844|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.66|TWO_SIDED|90.0|-5.13|8.9|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||8.90|-5.13|0.66
91551845|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.88|TWO_SIDED|90.0|-6.38|7.68|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||7.68|-6.38|0.88
91551846|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-53.83||||0.54|TWO_SIDED|90.0|-200.7|93.05|||ANOVA|||Ring/CA conc: 3% Type: ROI||93.05|-200.70|0.54
91551847|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-40.51||||0.65|TWO_SIDED|90.0|-187.01|105.98|||ANOVA|||Ring/CA conc: 3% Type: ROI||105.98|-187.01|0.65
91551848|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-52.99||||0.55|TWO_SIDED|90.0|-199.87|93.88|||ANOVA|||Ring/CA conc: 3% Type: ROI||93.88|-199.87|0.55
91551849|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-36.65||||0.18|TWO_SIDED|90.0|-81.85|8.56|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||8.56|-81.85|0.18
91551850|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-22.49||||0.41|TWO_SIDED|90.0|-67.58|22.59|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||22.59|-67.58|0.41
91551851|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-33.86||||0.22|TWO_SIDED|90.0|-79.06|11.34|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||11.34|-79.06|0.22
91551852|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-30.66||||0.74|TWO_SIDED|90.0|-183.08|121.76|||ANOVA|||Ring/CA conc: 10%, Type: ROI||121.76|-183.08|0.74
91551853|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-98.77||||0.28|TWO_SIDED|90.0|-250.79|53.25|||ANOVA|||Ring/CA conc: 10%, Type: ROI||53.25|-250.79|0.28
91551854|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-214.89||||0.02|TWO_SIDED|90.0|-367.31|-62.48|||ANOVA|||Ring/CA conc: 10%, Type: ROI||-62.48|-367.31|0.02
91551855|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.93|TWO_SIDED|90.0|-81.44|73.66|||ANOVA|||Ring/CA conc: 10% , Type: Entire Image||73.66|-81.44|0.93
91551856|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-191.02|||<|0.0001|TWO_SIDED|90.0|-268.37|-113.67|||ANOVA|||Ring/CA conc: 10% , Type: Entire Image||-113.67|-268.37|<.0001
91551857|NCT04183283|182987822|SUPERIORITY||Mean Difference (Final Values)|-252.24|||<|0.0001|TWO_SIDED|90.0|-329.79|-174.68|||ANOVA|||Ring/CA conc: 10%, Type: Entire Image||-174.68|-329.79|<.0001
91551858|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.99|TWO_SIDED|90.0|-8.28|8.15|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||8.15|-8.28|0.99
91551859|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.91|TWO_SIDED|90.0|-8.78|7.6|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||7.60|-8.78|0.91
91551860|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|2.53||||0.61|TWO_SIDED|90.0|-5.69|10.74|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||10.74|-5.69|0.61
91551861|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-1.29||||0.8|TWO_SIDED|90.0|-9.58|7.0|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||7.00|-9.58|0.80
91551862|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.77|TWO_SIDED|90.0|-6.83|9.72|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||9.72|-6.83|0.77
91551863|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|1.85||||0.71|TWO_SIDED|90.0|-6.45|10.14|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||10.14|-6.45|0.71
91551864|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-18.38||||0.38|TWO_SIDED|90.0|-53.27|16.51|||ANOVA|||Ring/CA conc: 3%, Type: ROI||16.51|-53.27|0.38
91551865|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.89|TWO_SIDED|90.0|-37.76|31.83|||ANOVA|||Ring/CA conc: 3%, Type: ROI||31.83|-37.76|0.89
91551866|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-10.12||||0.63|TWO_SIDED|90.0|-45.0|24.77|||ANOVA|||Ring/CA conc: 3%, Type: ROI||24.77|-45.00|0.63
91551867|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-11.31||||0.21|TWO_SIDED|90.0|-26.21|3.58|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||3.58|-26.21|0.21
91551868|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.72|TWO_SIDED|90.0|-18.04|11.67|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||11.67|-18.04|0.72
91551869|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-10.46||||0.25|TWO_SIDED|90.0|-25.35|4.44|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||4.44|-25.35|0.25
91551870|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|7.27||||0.69|TWO_SIDED|90.0|-22.71|37.25|||ANOVA|||Ring/CA conc: 10%, Type: ROI||37.25|-22.71|0.69
91551871|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-20.7||||0.25|TWO_SIDED|90.0|-50.6|9.2|||ANOVA|||Ring/CA conc: 10%, Type: ROI||9.2|-50.60|0.25
91551872|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-34.79||||0.06|TWO_SIDED|90.0|-64.77|-4.81|||ANOVA|||Ring/CA conc: 10%, Type: ROI||-4.81|-64.77|0.06
91551873|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|10.01||||0.51|TWO_SIDED|90.0|-15.4|35.42|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||35.42|-15.4|0.51
91551874|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-53.63|||<|0.001|TWO_SIDED|90.0|-78.98|-28.29|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||-28.29|-78.98|<0.001
91551875|NCT04183283|182987823|SUPERIORITY||Mean Difference (Final Values)|-79.5|||<|0.0001|TWO_SIDED|90.0|-104.91|-54.09|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||-54.09|-104.91|<.0001
91551876|NCT04228042|182987840|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
91551877|NCT04228042|182987840|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91551878|NCT04228042|182987840|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91551879|NCT04228042|182987840|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91551880|NCT04909801|182987857|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9026
91551881|NCT04909801|182987858|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.5824
91551882|NCT04909801|182987859|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534||95.0|0.5|1.3|||Regression, Logistic|||||1.3|0.5|0.3534
91551883|NCT04909801|182987860|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.6140
91551884|NCT04909801|182987862|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4996|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 29||1.4|0.5|0.4996
91551885|NCT04909801|182987862|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.449|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4490
91551886|NCT04909801|182987862|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.809|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 85||1.7|0.5|0.8090
91551887|NCT04909801|182987862|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.9||||0.0739|TWO_SIDED|95.0|0.9|3.6|||Regression, Logistic|||Day 113||3.6|0.9|0.0739
91551888|NCT04909801|182987862|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.4201|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 141||2.6|0.7|0.4201
91551889|NCT04909801|182987862|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7928|TWO_SIDED|95.0|0.6|2.0|||Regression, Logistic|||Day 169||2.0|0.6|0.7928
91551890|NCT04909801|182987863|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2701|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 29||1.3|0.4|0.2701
91551891|NCT04909801|182987863|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4863|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4863
91551892|NCT04909801|182987863|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9513|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.9513
91551893|NCT04909801|182987863|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8536|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 113||1.8|0.6|0.8536
91551894|NCT04909801|182987863|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9223|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 141||1.7|0.6|0.9223
91551895|NCT04909801|182987863|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||Day 169||1.6|0.6|0.9026
91551896|NCT04909801|182987864|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.3411|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||Day 29||1.6|0.2|0.3411
91551897|NCT04909801|182987864|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2546|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 57||1.3|0.4|0.2546
91551898|NCT04909801|182987864|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4558|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 85||1.4|0.5|0.4558
91551899|NCT04909801|182987864|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9544|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 113||1.7|0.6|0.9544
91551900|NCT04909801|182987864|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.545|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 141||1.4|0.5|0.5450
91551901|NCT04909801|182987864|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2227|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 169||1.2|0.4|0.2227
91767279|NCT01272232|183423872|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0008||95.0|1.75|8.41||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||8.41|1.75|0.0008
91767280|NCT01272232|183423872|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0099||95.0|1.16|2.95||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.95|1.16|0.0099
91767281|NCT01272232|183423873|SUPERIORITY_OR_OTHER||Treatment contrast|-0.93|||<|0.0001||95.0|-1.08|-0.78||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.78|-1.08|<0.0001
91767282|NCT01272232|183423873|SUPERIORITY_OR_OTHER||Treatment contrast|-0.74|||<|0.0001||95.0|-0.91|-0.57||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.57|-0.91|<0.0001
91551902|NCT04909801|182987865|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.32|TWO_SIDED|95.0|0.3|1.4|||Regression, Logistic|||Day 29||1.4|0.3|0.3200
91551903|NCT04909801|182987865|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4992|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.4992
91551904|NCT04909801|182987865|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8963|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.8963
91551905|NCT04909801|182987865|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4544|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 113||1.4|0.5|0.4544
91551906|NCT04909801|182987865|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8985|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 141||1.8|0.6|0.8985
91551907|NCT04909801|182987865|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.5824
91551908|NCT04909801|182987866|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.4152|TWO_SIDED|95.0|0.6|4.1|||Regression, Logistic|||Day 29||4.1|0.6|0.4152
91551909|NCT04909801|182987866|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5917|TWO_SIDED|95.0|0.6|2.5|||Regression, Logistic|||Day 57||2.5|0.6|0.5917
91551910|NCT04909801|182987866|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.4||||0.3348|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 85||2.6|0.7|0.3348
91551911|NCT04909801|182987866|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3959|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Day 113||1.4|0.4|0.3959
91551912|NCT04909801|182987866|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6225|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|||Day 141||2.0|0.7|0.6225
91551913|NCT04909801|182987866|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.6140
91551914|NCT04909801|182987867|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8084|TWO_SIDED|95.0|0.4|2.9|||Regression, Logistic|||Day 29||2.9|0.4|0.8084
91551915|NCT04909801|182987867|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.747|TWO_SIDED|95.0|0.5|2.3|||Regression, Logistic|||Day 57||2.3|0.5|0.7470
91551916|NCT04909801|182987867|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5233|TWO_SIDED|95.0|0.7|2.3|||Regression, Logistic|||Day 85||2.3|0.7|0.5233
91551917|NCT04909801|182987867|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7295|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 113||1.6|0.5|0.7295
91551918|NCT04909801|182987867|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7621|TWO_SIDED|95.0|0.6|1.9|||Regression, Logistic|||Day 141||1.9|0.6|0.7621
91551919|NCT04909801|182987867|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.6861|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 169||1.6|0.5|0.6861
91551920|NCT04909801|182987868|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3117|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 29||1.2|0.5|0.3117
91551921|NCT04909801|182987868|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.612|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.6120
91551922|NCT04909801|182987868|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4339|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 85||1.3|0.5|0.4339
91551923|NCT04909801|182987868|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.1963|TWO_SIDED|95.0|0.8|2.6|||Regression, Logistic|||Day 113||2.6|0.8|0.1963
91551924|NCT04909801|182987868|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3275|TWO_SIDED|95.0|0.8|2.3|||Regression, Logistic|||Day 141||2.3|0.8|0.3275
91551925|NCT04909801|182987868|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9113|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 169||1.7|0.6|0.9113
91551926|NCT04909801|182987869|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1247|TWO_SIDED|95.0|0.4|1.1|||Regression, Logistic|||Day 29||1.1|0.4|0.1247
91767283|NCT01272232|183423873|SUPERIORITY_OR_OTHER||Treatment contrast|-0.19||||0.0125||95.0|-0.34|-0.04||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.04|-0.34|0.0125
91767284|NCT01272232|183423874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.79|||<|0.0001||95.0|5.74|13.4||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||13.4|5.74|<0.0001
91767285|NCT01272232|183423874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.71|||<|0.0001||95.0|4.76|12.51||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||12.51|4.76|<0.0001
91551927|NCT04909801|182987869|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5656|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.5656
91551928|NCT04909801|182987869|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.897|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.8970
91551929|NCT04909801|182987869|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9175|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|||Day 113||1.6|0.7|0.9175
91551930|NCT04909801|182987869|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5996|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 141||1.7|0.7|0.5996
91551931|NCT04909801|182987869|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.3534
91551932|NCT04909801|182987870|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1641|TWO_SIDED|95.0|0.2|1.3|||Regression, Logistic|||Day 29||1.3|0.2|0.1641
91551933|NCT04909801|182987870|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5905|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.5905
91551934|NCT04909801|182987870|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7146|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.7146
91551935|NCT04909801|182987870|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7416|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 113||1.7|0.7|0.7416
91551936|NCT04909801|182987870|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 141||1.5|0.6|0.9026
91551937|NCT04909801|182987870|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.2605|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 169||1.2|0.5|0.2605
91551938|NCT04909801|182987871|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1078|TWO_SIDED|95.0|0.3|1.1|||Regression, Logistic|||Day 29||1.1|0.3|0.1078
91767286|NCT01272232|183423874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5319||95.0|0.76|1.71||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||1.71|0.76|0.5319
91551939|NCT04909801|182987871|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1855|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 57||1.2|0.4|0.1855
91551940|NCT04909801|182987871|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5223|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 85||1.4|0.6|0.5223
91551941|NCT04909801|182987871|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4078|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 113||1.3|0.5|0.4078
91551942|NCT04909801|182987871|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5238|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 141||1.8|0.7|0.5238
91551943|NCT04909801|182987871|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.474|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.4740
91551944|NCT04909801|182987872|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6565|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Day 29||2.9|0.5|0.6565
91551945|NCT04909801|182987872|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.701|TWO_SIDED|95.0|0.6|2.1|||Regression, Logistic|||Day 57||2.1|0.6|0.7010
91551946|NCT04909801|182987872|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3683|TWO_SIDED|95.0|0.8|2.1|||Regression, Logistic|||Day 85||2.1|0.8|0.3683
91551947|NCT04909801|182987872|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6372|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 113||1.8|0.7|0.6372
91551948|NCT04909801|182987872|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.2922|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 141||2.0|0.8|0.2922
91551949|NCT04909801|182987872|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8178|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 169||1.7|0.7|0.8178
91551950|NCT04909801|182987873|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9599|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||Day 29||2.2|0.4|0.9599
91551951|NCT04909801|182987873|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7899|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 57||1.7|0.5|0.7899
91551952|NCT04909801|182987873|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6305|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 85||1.9|0.7|0.6305
91551953|NCT04909801|182987873|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3491|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 113||2.0|0.8|0.3491
91551954|NCT04909801|182987873|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.4916|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 141||1.9|0.7|0.4916
91551955|NCT04909801|182987873|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5697|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 169||1.8|0.7|0.5697
91551956|NCT04909801|182987874|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.0977|TWO_SIDED|95.0|0.0|0.5|||longitudinal|||Day 29||0.5|-0.0|0.0977
91551957|NCT04909801|182987874|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.2889|TWO_SIDED|95.0|-0.1|0.5|||longitudinal|||Day 57||0.5|-0.1|0.2889
91551958|NCT04909801|182987874|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.7676|TWO_SIDED|95.0|-0.3|0.4|||longitudinal|||Day 85||0.4|-0.3|0.7676
91551959|NCT04909801|182987874|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.6157|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.6157
91767287|NCT01272232|183423875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|||<|0.0001||95.0|6.05|15.26||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||15.26|6.05|<0.0001
91767288|NCT01272232|183423875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98|||<|0.0001||95.0|3.59|9.97||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||9.97|3.59|<0.0001
91551960|NCT04909801|182987874|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.3904|TWO_SIDED|95.0|-0.4|0.2|||longitudinal|||Day 141||0.2|-0.4|0.3904
91551961|NCT04909801|182987874|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.8359|TWO_SIDED|95.0|-0.4|0.3|||longitudinal|||Day 169||0.3|-0.4|0.8359
91551962|NCT04909801|182987875|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.4||||0.7852|TWO_SIDED|95.0|-2.3|3.1|||longitudinal|||Day 29||3.1|-2.3|0.7852
91551963|NCT04909801|182987875|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6336|TWO_SIDED|95.0|-2.0|3.3|||longitudinal|||Day 57||3.3|-2.0|0.6336
91551964|NCT04909801|182987875|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.9||||0.4879|TWO_SIDED|95.0|-3.5|1.7|||longitudinal|||Day 85||1.7|-3.5|0.4879
91551965|NCT04909801|182987875|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2812|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.2812
91551966|NCT04909801|182987875|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1205|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1205
91551967|NCT04909801|182987875|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||longitudinal|||Day 169||1.3|-4.1|0.3001
91551968|NCT04909801|182987876|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.2||||0.4107|TWO_SIDED|95.0|-1.6|4.0|||longitudinal|||Day 29||4.0|-1.6|0.4107
91551969|NCT04909801|182987876|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.5||||0.6824|TWO_SIDED|95.0|-2.1|3.2|||longitudinal|||Day 57||3.2|-2.1|0.6824
91551970|NCT04909801|182987876|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.7||||0.5793|TWO_SIDED|95.0|-3.4|1.9|||longitudinal|||Day 85||1.9|-3.4|0.5793
91551971|NCT04909801|182987876|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2883|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 113||1.2|-4.2|0.2883
91551972|NCT04909801|182987876|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1285|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1285
91551973|NCT04909801|182987876|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2815|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 169||1.2|-4.2|0.2815
91551974|NCT04909801|182987881|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.3||||0.0099|TWO_SIDED|95.0|0.1|0.5|||longitudinal|||Day 29||0.5|0.1|0.0099
91551975|NCT04909801|182987881|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.1519|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 57||0.4|-0.1|0.1519
91551976|NCT04909801|182987881|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.2505|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 85||0.4|-0.1|0.2505
91551977|NCT04909801|182987881|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.5248|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.5248
91551978|NCT04909801|182987881|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.1778|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 141||0.2|-0.3|0.1778
91551979|NCT04909801|182987881|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.851|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 169||0.2|-0.3|0.8510
91551980|NCT04909801|182987882|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.3||||0.2319|TWO_SIDED|95.0|-0.9|3.5|||longitudinal|||Day 29||3.5|-0.9|0.2319
91551981|NCT04909801|182987882|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.5572|TWO_SIDED|95.0|-1.5|2.7|||longitudinal|||Day 57||2.7|-1.5|0.5572
91551982|NCT04909801|182987882|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.9366|TWO_SIDED|95.0|-2.0|2.1|||longitudinal|||Day 85||2.1|-2.0|0.9366
91551983|NCT04909801|182987882|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1508|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.1508
91551984|NCT04909801|182987882|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0303|TWO_SIDED|95.0|-3.6|-0.2|||longitudinal|||Day 141||-0.2|-3.6|0.0303
91551985|NCT04909801|182987882|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2333|TWO_SIDED|95.0|-3.3|0.8|||longitudinal|||Day 169||0.8|-3.3|0.2333
91551986|NCT04909801|182987883|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.9||||0.0938|TWO_SIDED|95.0|-0.3|4.2|||longitudinal|||Day 29||4.2|-0.3|0.0938
91551987|NCT04909801|182987883|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6053|TWO_SIDED|95.0|-1.6|2.7|||longitudinal|||Day 57||2.7|-1.6|0.6053
91551988|NCT04909801|182987883|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.857|TWO_SIDED|95.0|-1.9|2.3|||longitudinal|||Day 85||2.3|-1.9|0.8570
91551989|NCT04909801|182987883|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1592|TWO_SIDED|95.0|-3.0|0.5|||longitudinal|||Day 113||0.5|-3.0|0.1592
91551990|NCT04909801|182987883|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0319|TWO_SIDED|95.0|-3.7|-0.2|||longitudinal|||Day 141||-0.2|-3.7|0.0319
91551991|NCT04909801|182987883|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.3||||0.2059|TWO_SIDED|95.0|-3.4|0.7|||longitudinal|||Day 169||0.7|-3.4|0.2059
91551992|NCT05274074|182987892|SUPERIORITY||Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.2|||Regression, Linear|||||6.2|-3.4|0.57
91551993|NCT05274074|182987893|SUPERIORITY||Mean Difference (Net)|-0.1||||0.53|TWO_SIDED|95.0|-0.5|0.2|||Regression, Linear|||||0.2|-0.5|0.53
91551994|NCT05274074|182987894|SUPERIORITY||Mean Difference (Net)|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.4|||Regression, Linear|||||1.4|-3.3|0.41
91551995|NCT05274074|182987895|SUPERIORITY||Mean Difference (Net)|-0.9||||0.45|TWO_SIDED|95.0|-3.5|1.6|||Regression, Linear|||||1.6|-3.5|0.45
91551996|NCT05274074|182987896|SUPERIORITY||Mean Difference (Net)|3.3||||0.02|TWO_SIDED|95.0|0.5|6.2|||Regression, Linear|||||6.2|0.5|0.02
91551997|NCT05274074|182987897|SUPERIORITY||Mean Difference (Net)|-0.8||||0.69|TWO_SIDED|95.0|-4.9|3.3|||Regression, Linear|||||3.3|-4.9|0.69
91551998|NCT04117347|182987898|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.022|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.0861723|0.1309519|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for left amygdala.||0.1309519|-0.0861723|
91551999|NCT04117347|182987898|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.068|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.0363877|0.1730965|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for left amygdala.||0.1730965|-0.0363877|
91552000|NCT04117347|182987898|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.043|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.0676154|0.1545869|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for right amygdala.||0.1545869|-0.0676154|
91552001|NCT04117347|182987898|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.018|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.0888691|0.1255146|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for right amygdala.||0.1255146|-0.0888691|
91552002|NCT05194956|182987899|SUPERIORITY||Mean Difference (Net)|8.5||||0.0006|TWO_SIDED|95.0|3.75|13.15|||Two-period two-treatment crossover ANOVA|P-values are calculated taking sequence and period effects into account.|This estimation value assumes period and sequence effects are equal between the treatments.|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)||13.15|3.75|0.0006
91552003|NCT05194956|182987899|SUPERIORITY|Sequence effects||||||0.1984|||||||ANOVA|||||||0.1984
91552004|NCT05194956|182987899|SUPERIORITY|Period effects||||||0.7494|||||||ANOVA|||||||0.7494
91552005|NCT05194956|182987899|SUPERIORITY|Mixed effects modelling|Mean Difference (Net)|-13.31||||0.001|TWO_SIDED|95.0|-21.29|-5.33|||Mixed Models Analysis|||||-5.33|-21.29|0.001
91552006|NCT05194956|182987900|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.123|TWO_SIDED|95.0|-7.71|0.91||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.91|-7.71|0.1230
91552007|NCT05194956|182987900|SUPERIORITY|Sequence effects||||||0.8423|||||||ANOVA|||||||0.8423
91552008|NCT05194956|182987900|SUPERIORITY|Period effects||||||0.9544|||||||ANOVA|||||||0.9544
91552009|NCT05194956|182987901|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.0439|TWO_SIDED|95.0|-6.69|-0.12||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-0.12|-6.69|0.0439
91552010|NCT05194956|182987901|SUPERIORITY|Sequence effects||||||0.3878|||||||ANOVA|||||||0.3878
91552011|NCT05194956|182987901|SUPERIORITY|Period effects||||||0.9772|||||||ANOVA|||||||0.9772
91552012|NCT05194956|182987902|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|9.6||||0.0213|TWO_SIDED|95.0|1.5|17.79||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||17.79|1.50|0.0213
91552013|NCT05194956|182987902|SUPERIORITY|Sequence effects||||||0.1583|||||||ANOVA|||||||0.1583
91552014|NCT05194956|182987902|SUPERIORITY|Period effects||||||0.4709|||||||ANOVA|||||||0.4709
91767289|NCT01272232|183423875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.0142||95.0|1.1|2.34||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.34|1.10|0.0142
91552015|NCT05194956|182987903|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|5.3||||0.0146|TWO_SIDED|95.0|1.09|9.46||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||9.46|1.09|0.0146
91552016|NCT05194956|182987903|SUPERIORITY|Sequence effects||||||0.5911|||||||ANOVA|||||||0.5911
91552017|NCT05194956|182987903|SUPERIORITY|Period effects||||||0.5825|||||||ANOVA|||||||0.5825
91552018|NCT05194956|182987904|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-5.2||||0.0817|TWO_SIDED|95.0|-11.12|0.69||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-11.12|0.0817
91552019|NCT05194956|182987904|SUPERIORITY|Sequence effects||||||0.091|||||||ANOVA|||||||0.0910
91552020|NCT05194956|182987904|SUPERIORITY|Period effects||||||0.2278|||||||ANOVA|||||||0.2278
91552021|NCT05194956|182987905|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-2.2||||0.1347|TWO_SIDED|95.0|-5.17|0.69|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-5.17|0.1347
91552022|NCT05194956|182987905|SUPERIORITY|Sequence effects||||||0.9259|||||||ANOVA|||||||0.9259
91552023|NCT05194956|182987905|SUPERIORITY|Period effects||||||0.8225|||||||ANOVA|||||||0.8225
91552024|NCT05194956|182987906|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Median Difference (Net)|-11.2||||0.02|TWO_SIDED|95.0|-20.47|-1.83||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-1.83|-20.47|0.0200
91552025|NCT05194956|182987906|SUPERIORITY|Sequence effects||||||0.9104|||||||ANOVA|||||||0.9104
91552026|NCT05194956|182987906|SUPERIORITY|Period effects||||||0.5194|||||||ANOVA|||||||0.5194
91552027|NCT05194956|182987907|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-23.2|||<|5e-05|TWO_SIDED|95.0|-30.71|-15.75||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-15.75|-30.71|<0.00005
91767290|NCT01272232|183423876|SUPERIORITY_OR_OTHER||Treatment contrast|-3.22|||<|0.0001||95.0|-4.2|-2.23||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-2.23|-4.20|<0.0001
91552028|NCT05194956|182987907|SUPERIORITY|Sequence effects||||||0.1369|||||||ANOVA|||||||0.1369
91552029|NCT05194956|182987907|SUPERIORITY|Period effects||||||0.3366|||||||ANOVA|||||||0.3366
91552030|NCT05194956|182987908|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-120.0|||<|5e-05|TWO_SIDED|95.0|-149.54|-90.38|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||-90.38|-149.54|<0.00005
91552031|NCT05194956|182987908|SUPERIORITY|Sequence effects||||||0.8509|||||||ANOVA|||||||0.8509
91552032|NCT05194956|182987908|SUPERIORITY|Period effects||||||0.0355|||||||ANOVA|||||||0.0355
91552033|NCT03676192|182987910|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 95% confidence interval (CI) of the difference of ORR from each treatment group was entirely bounded by the interval (-12.5, 12.5).|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-7.02|7.83||||||Logistic regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||7.83|-7.02|
91552034|NCT03676192|182987910|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 90% confidence interval (CI) of the ratio of ORR from each treatment group was entirely bounded by the interval (0.7368, 1.3572).|Risk Ratio (RR)|1.0136|||||TWO_SIDED|90.0|0.8767|1.1719||||||Log-binomial regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||1.1719|0.8767|
91552035|NCT03676192|182987913|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.10|0.77|
91552036|NCT03676192|182987914|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.77|1.19||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.19|0.77|
91552037|NCT04778397|182987936|SUPERIORITY||Stratified Hazard Ratio|1.132||||0.507|TWO_SIDED|95.0|0.783|1.637|||Stratified log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.637|0.783|0.5070
91552038|NCT04778397|182987937|SUPERIORITY||Stratified Hazard Ratio|1.183||||0.3237|TWO_SIDED|95.0|0.845|1.654|||Stratified Log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.654|0.845|0.3237
91552039|NCT04778397|182987938|SUPERIORITY||Stratified Hazard Ratio|1.389||||0.0661|TWO_SIDED|95.0|1.043|1.848|||Stratified Log-rank test|P-value for comparing the event free survival functions from the two treatment groups was from stratified log-rank test, adjusted for randomization.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors: therapy appropriateness, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites).|1.848|1.043|0.0661
91552040|NCT04778397|182987939|SUPERIORITY||Stratified Odds Ratio|0.25|||||TWO_SIDED|95.0|0.123|0.506|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.506|0.123|
91552041|NCT04778397|182987940|SUPERIORITY||Stratified Odds Ratio|0.072|||||TWO_SIDED|95.0|0.009|0.559|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.559|0.009|
91552042|NCT04778397|182987941|SUPERIORITY||Stratified Odds Ratio|0.215|||||TWO_SIDED|95.0|0.108|0.428|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.428|0.108|
91552043|NCT03308877|182987948|OTHER|||||||0.07||||||Covariates include education \& percent days abstinent at baseline.|Regression, Linear|||Hypothesis 1: Affective psychopathy scores will moderate response to a BMI such that individuals with lower scores will benefit relative to controls, but individuals with higher psychopathy scores will not benefit from the intervention in terms of percent days abstinent.||||.07
91552044|NCT03308877|182987948|OTHER|||||||0.02|||||||Regression, Linear|||Sensitivity analysis: proximal follow-up (3 months following BMI or SC)||||.02
91552045|NCT03308877|182987948|OTHER||B|0.063|||<|0.01|TWO_SIDED|95.0|0.007|0.156|||Regression, Linear|bias corrected bootstrap||Increased readiness to change will be associated with decreased substance use.||.156|.007|<.01
91552046|NCT03308877|182987949|OTHER|||||||0.74|||||||Regression, Linear|||||||.74
91552047|NCT03308877|182987950|OTHER|||||||0.88|||||||Regression, Logistic|||||||.88
91552048|NCT03625115|182987972|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley cognitive scores between the groups.||||||0.3|||||||t-test, 2 sided|||||||0.30
91552049|NCT03625115|182987973|SUPERIORITY||Pearson chi square (1)|8.51||||0.004|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who completed a multidisciplinary evaluation (referral completed).||||.004
91552050|NCT03625115|182987974|SUPERIORITY||Pearson chi square (1)|0.05||||0.82|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who began early intervention services.||||.82
91552051|NCT03625115|182987975|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley language scores between the groups.||||||0.69|||||||t-test, 2 sided|||||||0.69
91552052|NCT03625115|182987977|EQUIVALENCE|two tailed t-test to compare the means of factor 1 between groups||||||0.858|||||||t-test, 2 sided|||Analysis of factor 1 items from the parent engagement questionnaire. Factor 1 (Buy-in) I am open to getting EI for my child. EI can help my child. EI can teach me new ways to help my child.||||.858
91552053|NCT03625115|182987977|EQUIVALENCE|two tailed t-test to compare the means of factor 2 between groups||||||0.995|||||||t-test, 2 sided|||"Analysis of factor 2 items from the parent engagement questionnaire.~Factor 2 (early intervention consequences):~EI could have negative consequences for my child. Getting EI for my child reflects negatively on me as a parent."||||.995
91552054|NCT03625115|182987977|EQUIVALENCE|two tailed t-test to compare the means of factor 3 between groups||||||0.049|||||||t-test, 2 sided|||"Analysis of factor 3 items from the parent engagement questionnaire.~Factor 3 (Knowledge/Self-Efficacy):~I know how to get EI for my child. I understand how the EI process works. If I have questions about EI, I know who to call. 12. I know my child's rights to EI under the law."||||.049
91552055|NCT03625115|182987978|SUPERIORITY||Odds Ratio (OR)|1.87||||0.02|TWO_SIDED|95.0|1.09|3.21|||Regression, Logistic|||A logistic regression was run to determine if the intervention arm, adjusted for child sex, income, maternal education, and primary care site, was associated with the completion of early intervention referrals for families with an adverse childhood experience survey score of greater than 2.||3.21|1.09|.02
91552056|NCT03655028|182987985|SUPERIORITY|||||||0.85||||||The co-variate used in the analysis was the 6 minute walk distance at baseline.|ANCOVA|||||||0.85
91767291|NCT01272232|183423876|SUPERIORITY_OR_OTHER||Treatment contrast|-2.06||||0.0004||95.0|-3.2|-0.92||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.92|-3.20|0.0004
91767292|NCT01272232|183423876|SUPERIORITY_OR_OTHER||Treatment contrast|-1.16||||0.0224||95.0|-2.16|-0.16||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.16|-2.16|0.0224
91767293|NCT01272232|183423877|SUPERIORITY_OR_OTHER||Treatment contrast|-2.17||||0.0002||95.0|-3.32|-1.02||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.02|-3.32|0.0002
91767294|NCT01272232|183423877|SUPERIORITY_OR_OTHER||Treatment contrast|-1.2||||0.0725||95.0|-2.51|0.11||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.11|-2.51|0.0725
91552057|NCT03655028|182987986|SUPERIORITY|||||||0.307||||||The co-variant used to adjust the ANCOVA was the baseline step count/day.|ANCOVA|||||||.307
91552058|NCT03655028|182987987|SUPERIORITY|||||||0.106||||||this comparison is made between distance walked during 6MW at 12 weeks and distance walked during 6MW at 24 weeks|ANCOVA|||||||0.106
91552059|NCT03655028|182987988|SUPERIORITY|||||||0.26||||||Baseline PCS score was used at the co-variate|ANCOVA|||||||0.26
91552060|NCT03655028|182987989|SUPERIORITY|||||||0.85||||||Covariate was baseline MCS score|ANCOVA|||||||0.85
91552061|NCT03655028|182987990|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
91767295|NCT01272232|183423877|SUPERIORITY_OR_OTHER||Treatment contrast|-0.97||||0.0717||95.0|-2.02|0.09||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.09|-2.02|0.0717
91552062|NCT05256654|182988018|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|6.92||0.691|TWO_SIDED|95.0|-15.5|11.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (Triglycerides (TG) \<250 milligram per deciliter (mg/dL) or \>=250 mg/dL at screening), and the interaction between treatment and time.|||11.9|-15.5|0.691
91552063|NCT05256654|182988018|SUPERIORITY||Mean Difference (Net)|-14.3|STANDARD_ERROR_OF_MEAN|4.98||0.008|TWO_SIDED|95.0|-23.6|-3.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-3.9|-23.6|0.008
91552064|NCT05256654|182988018|SUPERIORITY||Mean Difference (Net)|-8.3|STANDARD_ERROR_OF_MEAN|5.36||0.14|TWO_SIDED|95.0|-18.3|2.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.9|-18.3|0.140
91552065|NCT05256654|182988019|SUPERIORITY||Mean Difference (Net)|-54.3|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|95.0|-63.3|-43.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.1|-63.3|<.001
91552066|NCT05256654|182988019|SUPERIORITY||Mean Difference (Net)|-69.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-74.8|-63.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-63.9|-74.8|<.001
91767296|NCT01272232|183423879|SUPERIORITY_OR_OTHER||Treatment contrast|-2.49|||<|0.0001||95.0|-3.75|-1.24||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.24|-3.75|<0.0001
91552067|NCT05256654|182988019|SUPERIORITY||Mean Difference (Net)|-76.6|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-80.4|-72.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-72.0|-80.4|<.001
91552068|NCT05256654|182988020|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|7.24||0.854|TWO_SIDED|95.0|-14.6|14.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||14.0|-14.6|0.854
91552069|NCT05256654|182988020|SUPERIORITY||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|4.98||0.002|TWO_SIDED|95.0|-26.0|-6.4|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.4|-26.0|0.002
91552070|NCT05256654|182988020|SUPERIORITY||Mean Difference (Net)|-12.1|STANDARD_ERROR_OF_MEAN|5.28||0.033|TWO_SIDED|95.0|-21.9|-1.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.1|-21.9|0.033
91552071|NCT05256654|182988021|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|4.03||0.143|TWO_SIDED|95.0|-13.8|2.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.2|-13.8|0.143
91552072|NCT05256654|182988021|SUPERIORITY||Mean Difference (Net)|-16.4|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-22.0|-10.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-10.5|-22.0|<.001
91552073|NCT05256654|182988021|SUPERIORITY||Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-27.9|-17.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.2|-27.9|<.001
91552074|NCT05256654|182988022|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.068|TWO_SIDED|95.0|-21.1|0.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||0.9|-21.1|0.068
91552075|NCT05256654|182988022|SUPERIORITY||Mean Difference (Net)|-25.5|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-32.6|-17.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.6|-32.6|<.001
91552076|NCT05256654|182988022|SUPERIORITY||Mean Difference (Net)|-23.8|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-31.1|-15.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-15.7|-31.1|<.001
91552077|NCT05256654|182988023|SUPERIORITY||Mean Difference (Net)|-36.3|STANDARD_ERROR_OF_MEAN|5.21|<|0.001|TWO_SIDED|95.0|-45.8|-25.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-25.1|-45.8|<.001
91552078|NCT05256654|182988023|SUPERIORITY||Mean Difference (Net)|-50.3|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-56.4|-43.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.3|-56.4|<.001
91552079|NCT05256654|182988023|SUPERIORITY||Mean Difference (Net)|-52.5|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-58.4|-45.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-45.9|-58.4|<.001
91552080|NCT05256654|182988024|SUPERIORITY||Mean Difference (Net)|-38.6|STANDARD_ERROR_OF_MEAN|7.76|<|0.001|TWO_SIDED|95.0|-52.2|-21.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-21.2|-52.2|<.001
91552081|NCT05256654|182988024|SUPERIORITY||Mean Difference (Net)|-54.0|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-62.4|-43.8|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.8|-62.4|<.001
91552082|NCT05256654|182988024|SUPERIORITY||Mean Difference (Net)|-63.6|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-70.3|55.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||55.5|-70.3|<.001
91552083|NCT05256654|182988025|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|5.99||0.506|TWO_SIDED|95.0|-15.2|8.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||8.5|-15.2|0.506
91552084|NCT05256654|182988025|SUPERIORITY||Mean Difference (Net)|-19.7|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-27.2|-11.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.3|-27.2|<.001
91552085|NCT05256654|182988025|SUPERIORITY||Mean Difference (Net)|-19.4|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.0|-11.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.0|-27.0|<.001
91552086|NCT05256654|182988026|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|4.16||0.428|TWO_SIDED|95.0|-11.2|5.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||5.2|-11.2|0.428
91552087|NCT05256654|182988026|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_ERROR_OF_MEAN|3.14||0.009|TWO_SIDED|95.0|-14.7|-2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-2.3|-14.7|0.009
91552088|NCT05256654|182988026|SUPERIORITY||Mean Difference (Net)|-12.2|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-18.0|-6.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.0|-18.0|<.001
91552089|NCT05256654|182988027|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|8.1||0.412|TWO_SIDED|95.0|-8.4|23.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||23.7|-8.4|0.412
91552090|NCT05256654|182988027|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|5.52||0.104|TWO_SIDED|95.0|-19.7|2.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.1|-19.7|0.104
91552091|NCT05256654|182988027|SUPERIORITY||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|5.79||0.363|TWO_SIDED|95.0|-16.2|6.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||6.7|-16.2|0.363
91552092|NCT05256654|182988028|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|6.19||0.101|TWO_SIDED|95.0|-22.2|2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.3|-22.2|0.101
91552093|NCT05256654|182988028|SUPERIORITY||Mean Difference (Net)|-11.3|STANDARD_ERROR_OF_MEAN|4.96||0.033|TWO_SIDED|95.0|-20.6|-1.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.0|-20.6|0.033
91552094|NCT05256654|182988028|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|4.98||0.04|TWO_SIDED|95.0|-20.3|-0.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-0.6|-20.3|0.040
91552095|NCT05256654|182988029|SUPERIORITY||Mean Difference (Net)|-28.3|STANDARD_ERROR_OF_MEAN|6.79|<|0.001|TWO_SIDED|95.0|-40.5|-13.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-13.6|-40.5|<.001
91552096|NCT05256654|182988029|SUPERIORITY||Mean Difference (Net)|-42.5|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-50.5|-33.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-33.2|-50.5|<.001
91552097|NCT05256654|182988029|SUPERIORITY||Mean Difference (Net)|-44.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-52.5|-35.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-35.9|-52.5|<.001
91552098|NCT02709161|182988031|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91552099|NCT02709161|182988032|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
91552100|NCT05207982|182988059|OTHER|||||||||||||||||This study utilized a multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling. Separate models were developed for each participant which include the daily weights from the baseline, treatment and follow-up phases. Given the nature of the data, we hypothesized different slopes for the baseline vs treatment phases. Overall weight change was a primary outcome measure.|Multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling.|||
91552101|NCT04089059|182988075|SUPERIORITY|Poisson regression for comparison of incidence rate against performance goal (0.43)|||||<|0.0001|||||||Poisson Regression|||||||<0.0001
91552102|NCT04089059|182988078|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison of HF Hospitalization events 6 months before implant vs 6 months after implant||||<0.0001
91552103|NCT04089059|182988079|SUPERIORITY|Comparison of the incidence rate of HF hospitalizations or emergency department / hospital outpatient IV diuretic visits of Former Control Arm versus Modified Intent to Treat Arm at 6 months post-implant/Subgroup Analysis||||||0.0697|||||||Poisson Regression|||||||0.0697
91552104|NCT04089059|182988082|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.0952|||||||Wilcoxon (Mann-Whitney)|||||||0.0952
91552105|NCT04089059|182988082|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.0090
91552106|NCT04089059|182988082|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91552107|NCT04089059|182988084|SUPERIORITY|Comparison of KCCQ at baseline and at 6 months||||||0.0026|||||||Wilcoxon (Mann-Whitney)|||||||0.0026
91552108|NCT04089059|182988085|OTHER|Test of difference in distribution of NYHA class from baseline (all patients were class III at baseline).|||||<|0.0001|||||||Chi-squared|||The New York Heart Association (NYHA) Classification is a system used to evaluate and classify the severity of heart failure based on symptoms, patient's physical activity, and quality of life. Its scale ranges from class 1 to 4 with class 1 indicating the least severe heart failure symptoms (i.e., the best functionality) and class 4 indicating the most severe heart failure symptoms (i.e., the poorest functionality), with higher classes indicating poorer functioning as relates to heart failure.||||<0.0001
91767297|NCT01272232|183423879|SUPERIORITY_OR_OTHER||Treatment contrast|-1.47||||0.0457||95.0|-2.92|-0.03||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.03|-2.92|0.0457
91767298|NCT01272232|183423879|SUPERIORITY_OR_OTHER||Treatment contrast|-1.02||||0.0961||95.0|-2.22|0.18||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.18|-2.22|0.0961
91767299|NCT00255190|183423931|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.042
91552109|NCT04089059|182988086|SUPERIORITY|Comparison of baseline 6MWT vs 6 month 6MWT.||||||0.1086|||||||Wilcoxon (Mann-Whitney)|||||||0.1086
91767300|NCT00255190|183423932|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.006
91767301|NCT00255190|183423933|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using a one-way analysis of covariance (ANCOVA) model with treatment as the factor and baseline score as the covariate.||||||0.204
91552110|NCT04089059|182988089|SUPERIORITY|Compare NTproBNP at baseline with 6 months||||||0.0628|||||||Wilcoxon (Mann-Whitney)|||||||0.0628
91552111|NCT02800356|182988105|OTHER|||||||0.404|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.404
91552112|NCT02800356|182988106|OTHER|||||||0.232|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.232
91552113|NCT02800356|182988107|OTHER|||||||0.001|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.001
91552114|NCT02800356|182988110|OTHER|||||||0.267|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.267
91552115|NCT03295721|182988138|SUPERIORITY||Least Squares Mean Difference (LSMD)|-122.05|STANDARD_ERROR_OF_MEAN|21.217|<|0.0001|TWO_SIDED|95.0|-163.76|-80.34|||ANOVA|||||-80.34|-163.76|< 0.0001
91552116|NCT03295721|182988139|SUPERIORITY||Least Squares Mean Difference (LSMD)|-70.16|STANDARD_ERROR_OF_MEAN|18.777|=|0.0002|TWO_SIDED|95.0|-107.07|-33.25|||ANOVA|||||-33.25|-107.07|= 0.0002
91552117|NCT03295721|182988140|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
91552118|NCT03295721|182988141|SUPERIORITY||Risk Difference (RD)|0.177||||0.0001|TWO_SIDED|95.0|0.085|0.265|||Fisher Exact|||||.265|.085|0.0001
91552119|NCT03295721|182988142|SUPERIORITY||||||=|0.0022|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0022
91552120|NCT01651403|182988158|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||< 0.001
91552121|NCT01651403|182988158|SUPERIORITY||||||<|0.001|||||||Fisher Exact|Fisher's exact test without adjusting for strata at baseline||||||< 0.001
91552122|NCT01651403|182988159|SUPERIORITY|||||||0.935|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||0.935
91552123|NCT01651403|182988160|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.001
91552124|NCT01651403|182988162|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
91552125|NCT01651403|182988164|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.002
91552126|NCT01651403|182988166|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
91552127|NCT01651403|182988168|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
91552128|NCT01651403|182988170|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
91552129|NCT01651403|182988172|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
91552130|NCT01651403|182988174|SUPERIORITY||||||>|0.999|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||>0.999
91552131|NCT01651403|182988182|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
91552132|NCT01651403|182988183|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
91552133|NCT01651403|182988184|SUPERIORITY|||||||0.007|||||||ANOVA|two-sided superiority test||||||0.007
91552134|NCT01651403|182988186|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
91767302|NCT00255190|183423934|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.109
91767303|NCT00255190|183423935|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
91552135|NCT04070573|182988233|SUPERIORITY||Risk Difference (RD)|0.035||||0.28|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.28
91552136|NCT04070573|182988234|SUPERIORITY||Risk Difference (RD)|0.035||||0.31|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.31
91552137|NCT04070573|182988235|SUPERIORITY||Risk Difference (RD)|0.019||||0.61|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.61
91552138|NCT04070573|182988238|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED||||||t-test, 2 sided|||||||0.72
91552139|NCT04479761|182988273|OTHER|T test derived from a linear mixed effects model|Mean Difference (Final Values)|0.52||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis||we provided the mean difference between the vestibular group and healthy controls for the reported condition.|||||0.005
91552140|NCT04479761|182988274|OTHER|T tests derived from linear mixed effects model|Mean Difference (Final Values)|0.23||||0.008|TWO_SIDED||||||Mixed Models Analysis||we provided the mean difference between the vestibular group and the controls on the reported condition.|||||0.008
91767304|NCT00255190|183423936|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.494
91552141|NCT05309291|182988275|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for λ FLC RR can be expressed as: Ho: μT-μR ≤ -3.783. The alternative hypothesis is expressed as: Ha: μT-μR \> -3.783 where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|16.99|STANDARD_DEVIATION|8.86|<|0.0001|TWO_SIDED|95.0|14.84|19.15|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the λ FLC RR at the mid-week treatment day dialysis session was assessed.||19.15|14.84|<0.0001
91552142|NCT05309291|182988276|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for ß2-MG RR can be expressed as Ho: μT-μR ≤ -7.848. The alternative hypothesis is expressed as: Ha: μT-μR \> -7.848, where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|5.55|<|0.0001|TWO_SIDED|95.0|-2.54|0.16|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the β2-MG RR at the mid-week treatment day dialysis session was assessed.||0.16|-2.54|<0.0001
91552143|NCT05452460|182988318|SUPERIORITY||Mean Difference (Final Values)|0.11|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in RT as the outcome, with Group as the factor, and pre-test condition difference in RT as the covariate.||||||> 0.05
91552144|NCT05452460|182988319|SUPERIORITY||Mean Difference (Final Values)|0.18|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in ACC the outcome, with Group as the factor, and pre-test condition difference in ACC as the covariate.||||||> .05
91552145|NCT05452460|182988320|SUPERIORITY||Mean Difference (Final Values)|0.32|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in N2 the outcome, with Group as the factor, and pre-test condition difference in N2 as the covariate.||||||> 0.05
91552146|NCT05452460|182988321|SUPERIORITY||Mean Difference (Final Values)|0.71|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in P3 the outcome, with Group as the factor, and pre-test condition difference in P3 as the covariate.||||||> 0.05
91552147|NCT05452460|182988322|SUPERIORITY||Mean Difference (Final Values)|13.35|||<|0.01|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in TTE the outcome, with Group as the factor, and pre-test condition difference in TTE as the covariate.|\[F(1, 52) = 13.35, p = .001, ηp2 = .211\]|||||< 0.01
91552148|NCT05452460|182988323|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in VO2max Covariate: Pre-test condition difference in VO2max||||||> 0.05
91552149|NCT05452460|182988324|SUPERIORITY||Mean Difference (Final Values)|38.76|||<|0.01|TWO_SIDED||||||ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 3 (ASSESSMENT TIME) × 2 (Experiment Phase)||||||< 0.01
91552150|NCT05452460|182988325|SUPERIORITY||Mean Difference (Final Values)|9.21|||<|0.01|TWO_SIDED|||||The main effect of the Stroop block on accuracy showed a decrease from the first block to the fifth block.|ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 5 (BLOCK) × 2 (Phase)||||||< 0.01
91552151|NCT05452460|182988326|SUPERIORITY||Mean Difference (Final Values)|7.07|||<|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test mean score Covariate: Pre-test mean score||||||< 0.05
91552152|NCT05452460|182988327|SUPERIORITY||Mean Difference (Final Values)|1.37|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed anger Covariate: Pre-test condition difference in changed anger||||||> 0.05
91552153|NCT05452460|182988328|SUPERIORITY||Mean Difference (Final Values)|2.73|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
91552154|NCT05452460|182988329|SUPERIORITY||Mean Difference (Final Values)|0.07|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed depression Covariate: Pre-test condition difference in changed depression||||||> 0.05
91552155|NCT05452460|182988330|SUPERIORITY||Mean Difference (Final Values)|0.2|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed fatigue Covariate: Pre-test condition difference in changed fatigue||||||> 0.05
91552156|NCT05452460|182988331|SUPERIORITY||Mean Difference (Final Values)|0.01|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
91552157|NCT05452460|182988332|SUPERIORITY||Mean Difference (Final Values)|0.66|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
91552158|NCT04447040|182988335|SUPERIORITY||Least square (LS) Mean Difference|31.48|STANDARD_ERROR_OF_MEAN|5.379|<|0.001|TWO_SIDED|95.0|20.9|42.07|||ANOVA|||||42.07|20.90|<0.001
91552159|NCT04447040|182988335|SUPERIORITY||LS Mean Difference|41.38|STANDARD_ERROR_OF_MEAN|5.267|<|0.001|TWO_SIDED|95.0|31.02|51.75|||ANOVA|||||51.75|31.02|<0.001
91552160|NCT04447040|182988335|SUPERIORITY||LS Mean Difference|46.86|STANDARD_ERROR_OF_MEAN|5.292|<|0.001|TWO_SIDED|95.0|36.44|57.27|||ANOVA|||||57.27|36.44|<0.001
91552161|NCT04447040|182988335|SUPERIORITY||LS Mean Difference|54.04|STANDARD_ERROR_OF_MEAN|5.321|<|0.001|TWO_SIDED|95.0|43.57|64.51|||ANOVA|||||64.51|43.57|<0.001
91552162|NCT04447040|182988335|SUPERIORITY||LS Mean Difference|59.92|STANDARD_ERROR_OF_MEAN|5.468|<|0.001|TWO_SIDED|95.0|49.16|70.68|||ANOVA|||||70.68|49.16|<0.001
91552163|NCT04447040|182988336|SUPERIORITY||LS Mean Difference|35.66|STANDARD_ERROR_OF_MEAN|6.542|<|0.001|TWO_SIDED|95.0|22.79|48.54|||ANOVA|||||48.54|22.79|<0.001
91552164|NCT04447040|182988336|SUPERIORITY||LS Mean Difference|49.04|STANDARD_ERROR_OF_MEAN|6.407|<|0.001|TWO_SIDED|95.0|36.44|61.65|||ANOVA|||||61.65|36.44|<0.001
91552165|NCT04447040|182988336|SUPERIORITY||LS Mean Difference|53.64|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|40.97|66.31|||ANOVA|||||66.31|40.97|<0.001
91552166|NCT04447040|182988336|SUPERIORITY||LS Mean Difference|60.93|STANDARD_ERROR_OF_MEAN|6.472|<|0.001|TWO_SIDED|95.0|48.19|73.67|||ANOVA|||||73.67|48.19|<0.001
91552167|NCT04447040|182988336|SUPERIORITY||LS Mean Difference|67.58|STANDARD_ERROR_OF_MEAN|6.65|<|0.001|TWO_SIDED|95.0|54.49|80.67|||ANOVA|||||80.67|54.49|<0.001
91552168|NCT04447040|182988337|SUPERIORITY||LS mean Difference|12.53|STANDARD_ERROR_OF_MEAN|3.097|<|0.001|TWO_SIDED|95.0|6.44|18.63|||ANOVA|||||18.63|6.44|<0.001
91552169|NCT04447040|182988337|SUPERIORITY||LS MEAN Difference|17.73|STANDARD_ERROR_OF_MEAN|3.032|<|0.001|TWO_SIDED|95.0|11.76|23.7|||ANOVA|||||23.70|11.76|<0.001
91552170|NCT04447040|182988337|SUPERIORITY||LS Mean Difference|21.88|STANDARD_ERROR_OF_MEAN|3.047|<|0.001|TWO_SIDED|95.0|15.89|27.88|||ANOVA|||||27.88|15.89|<0.001
91552171|NCT04447040|182988337|SUPERIORITY||LS Mean Difference|25.01|STANDARD_ERROR_OF_MEAN|3.063|<|0.001|TWO_SIDED|95.0|18.98|31.03|||ANOVA|||||31.03|18.98|<0.001
91552172|NCT04447040|182988337|SUPERIORITY||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|95.0|23.11|35.5|||ANOVA|||||35.50|23.11|<0.001
91552173|NCT04447040|182988338|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
91552174|NCT04447040|182988338|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
91552175|NCT04447040|182988338|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
91552176|NCT04447040|182988338|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
91552177|NCT04447040|182988338|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
91552178|NCT04447040|182988339|SUPERIORITY|||||||0.014|||||||Wald method|||||||0.014
91552179|NCT04447040|182988339|SUPERIORITY|||||||0.002|||||||Wald method|||||||0.002
91552180|NCT04447040|182988339|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
91552181|NCT04447040|182988339|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
91552182|NCT04447040|182988339|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
91552183|NCT01208662|182988340|SUPERIORITY||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.91|||Log Rank|Observed Stratified Log Rank Test (1-sided p-value)||||1.91|1.23|<0.001
91552184|NCT01208662|182988341|SUPERIORITY|||||||0.55|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.55
91552185|NCT01208662|182988342|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
91552186|NCT01208662|182988343|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
91552187|NCT01208662|182988345|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|99.29|1.21|2.27|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||2.27|1.21|<0.001
91552188|NCT01208662|182988346|SUPERIORITY||Hazard Ratio (HR)|1.1|||>|0.99|TWO_SIDED|95.0|0.73|1.65|||Log Rank|||||1.65|0.73|>0.99
91552189|NCT01208662|182988348|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.99|TWO_SIDED|99.29|0.73|1.65|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||1.65|0.73|0.99
91552190|NCT01208662|182988355|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.3|1.01||||||||1.01|0.30|
91552191|NCT04433208|182988364|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91552192|NCT05485779|182988380|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.17||||0.6358|TWO_SIDED|95.0|1.07|1.27|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 30.4. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.27|1.07|0.6358
91552193|NCT05485779|182988380|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.5506|TWO_SIDED|95.0|0.963|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 32.9. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|0.963|0.5506
91552194|NCT05485779|182988381|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.3653|TWO_SIDED|95.0|1.04|1.22|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 25.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.22|1.04|0.3653
91552195|NCT05485779|182988381|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.2933|TWO_SIDED|95.0|1.01|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 27.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|1.01|0.2933
91552196|NCT05485779|182988382|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.46|TWO_SIDED|95.0|0.908|1.41|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 64.3. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.41|0.908|0.4600
91552197|NCT05485779|182988382|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12||||0.3157|TWO_SIDED|95.0|0.795|1.45|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 65.6. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.45|0.795|0.3157
91552198|NCT05485779|182988383|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.2||||0.235|TWO_SIDED|95.0|1.02|1.37|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 54.2. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.37|1.02|0.2350
91552199|NCT05485779|182988383|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.19||||0.1632|TWO_SIDED|95.0|0.88|1.5|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 58.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.50|0.880|0.1632
91767305|NCT00255190|183423937|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.026
91767306|NCT00255190|183423938|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.220
91767307|NCT00255190|183423939|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.843
91552200|NCT05485779|182988384|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.977|||||TWO_SIDED|90.0|0.915|1.04|||||Within-subject geometric coefficient of variation was 5.66. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.04|0.915|
91552201|NCT05485779|182988385|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.805|||||TWO_SIDED|90.0|0.635|1.02|||||Within-subject geometric coefficient of variation was 20.5. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.02|0.635|
91552202|NCT05485779|182988387|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.15||||0.1558|TWO_SIDED|95.0|0.954|1.34|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 28.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.34|0.954|0.1558
91552203|NCT05485779|182988388|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1||||0.5458|TWO_SIDED|95.0|0.946|1.26|||Lack of Fit 2-sided model|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 24.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.26|0.946|0.5458
91552204|NCT05485779|182988389|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.941||||0.4856|TWO_SIDED|95.0|0.602|1.28||Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Lack of fit 2-sided||Between-subject geometric coefficient of variation was 54.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.602|0.4856
91552205|NCT05485779|182988390|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971||||0.1455|TWO_SIDED|95.0|0.666|1.28|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 45.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.666|0.1455
91552206|NCT02010242|182988391|SUPERIORITY|All statistical analyses were performed on a comparison-wise basis without adjustment for multiple comparisons.||||||1|||||||ANCOVA|||Primary efficacy endpoint was analyzed using ANCOVA comparing GKT137831 vs placebo after controlling for the baseline UACR level. The UACR were log-transformed prior to analysis. The model included treatment group and log-transformed baseline UACR value as predicted variables. The results were back-transformed exponentially to calculate geo. mean values and associated 90% CIs and 1-sided p-values. The null hypothesis was that the difference in the adjusted mean logarithm of UACR was equal to 0||||1.000
91552207|NCT05163496|182988515|SUPERIORITY||Mean Difference (Net)|12.0|STANDARD_DEVIATION|0.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that the mean change in MADRS score from the preparation 1 session to day 28 would be the same in both niacin and psilocybin groups. The alternative hypothesis was that the change in the psilocybin group would be greater than the change in the niacin group, with an assumed true effect size of 1.06 SD units based on findings in prior studies. With 15 participants per group, this study had 80% power to observe a statistically significant difference between groups.||||<.001
91552208|NCT04685135|182988531|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Log Rank|HR and CI are from stratified Cox proportional hazard model||||0.76|0.45|<0.0001
91552209|NCT04685135|182988533|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.56|8.56|||Cochran Mantel Haenszel chi-square test|||||8.56|2.56|<0.0001
91552210|NCT02724969|182988568|SUPERIORITY|||||||0.272|||||||Mixed Models Analysis|||||||.272
91552211|NCT02724969|182988569|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||.082
91552212|NCT02724969|182988570|SUPERIORITY|||||||0.355|||||||Mixed Models Analysis|||||||.355
91552213|NCT02724969|182988571|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||.780
91552214|NCT02724969|182988572|SUPERIORITY|||||||0.588|||||||Mixed Models Analysis|||||||.588
91552215|NCT04911296|182988591|OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
91552216|NCT04911296|182988592|OTHER|||||||0.536|||||||Fisher Exact|||||||0.536
91552217|NCT04625725|182988650|SUPERIORITY||Relative Risk Reduction|76.73|||<|0.001|TWO_SIDED|95.0|46.05|89.96|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Primary Analysis||89.96|46.05|<0.001
91767308|NCT00255190|183423940|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.923
91767309|NCT00255190|183423941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
91767310|NCT00255190|183423942|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.758
91552218|NCT04625725|182988650|SUPERIORITY||Relative Risk Reduction|83.04|||<|0.001|TWO_SIDED|95.0|67.26|91.21|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Final Analysis||91.21|67.26|<0.001
91552219|NCT04625725|182988652|SUPERIORITY||Relative Risk Reduction|34.9|||<|0.001|TWO_SIDED|95.0|21.44|46.05|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||46.05|21.44|<0.001
91552220|NCT04625725|182988653|SUPERIORITY||Relative Risk Reduction|91.41||||0.001|TWO_SIDED|95.0|61.31|98.09|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||98.09|61.31|0.001
91552221|NCT04625725|182988654|SUPERIORITY||Relative Risk Reduction|52.43||||0.137|TWO_SIDED|95.0|-26.61|82.13|||Poisson regression|||||82.13|-26.61|0.137
91552222|NCT05086796|182988680|SUPERIORITY||Risk Ratio (RR)|2.1|||||TWO_SIDED|97.5|1.51|2.91|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), prior exposure to MOUD (yes vs. no), and length of hospital stay in days.|2.91|1.51|
91552223|NCT05086796|182988681|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|97.5|1.15|1.93|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who linked to follow-up OUD care by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|1.93|1.15|
91552224|NCT05086796|182988682|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|1.35|2.41|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.41|1.35|
91552225|NCT05086796|182988683|SUPERIORITY||Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|1.23|2.39|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported any post-discharge MOUD utilization between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.39|1.23|
91552226|NCT05086796|182988684|SUPERIORITY||Risk Ratio (RR)|1.89|||||TWO_SIDED|95.0|1.18|3.03|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported receiving any post-discharge outpatient medical care for their OUD between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: site (3 sites), and prior exposure to MOUD (yes vs. no).|3.03|1.18|
91552227|NCT05086796|182988685|SUPERIORITY||Incident rate ratio|1.25|||||TWO_SIDED|95.0|0.64|2.43|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable negative binomial regression with a log link function was used to compare opioid use-days between the two treatment arms by calculating the incident rate ratio (IRR) and 95% confidence interval (CI) with covariates: site (3 sites), prior exposure to MOUD (yes vs. no), and baseline opioid use days.|2.43|0.64|
91552228|NCT00429364|182988686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.08
91552229|NCT00429364|182988687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.20
91552230|NCT00429364|182988688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.15
91552231|NCT00429364|182988689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.30
91767311|NCT00255190|183423943|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.737
91767312|NCT00255190|183423944|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.673
91767313|NCT00255190|183423945|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.817
91767314|NCT00255190|183423946|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.601
91767315|NCT00255190|183423947|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.065
91767316|NCT00255190|183423948|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.319
91767317|NCT00255190|183423949|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.011
91767318|NCT00255190|183423950|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.207
91552232|NCT00429364|182988690|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||<0.001
91552233|NCT00429364|182988691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.002
91552234|NCT00429364|182988692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.29
91552235|NCT00429364|182988693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Regression model adjusted for age at study visit.|Mixed Models Analysis|||||||0.96
91552236|NCT00429364|182988694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
91552237|NCT00429364|182988695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91552238|NCT00429364|182988696|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
91552239|NCT00429364|182988697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
91552240|NCT00429364|182988698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||0.82
91552241|NCT00429364|182988699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
91767319|NCT00255190|183423951|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.286
91552242|NCT00429364|182988700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
91552243|NCT00429364|182988701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
91552244|NCT00429364|182988703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Log Rank|||||||0.16
91552245|NCT00429364|182988705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Log Rank|||||||0.13
91552246|NCT00429364|182988707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|||||||0.32
91552247|NCT00429364|182988709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||Log Rank|||||||0.10
91552248|NCT05873556|182988712|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.97||||0.83|TWO_SIDED|95.0|0.74|1.27|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.27|0.74|0.83
91552249|NCT05873556|182988712|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.07||||0.61|TWO_SIDED|95.0|0.83|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.83|0.61
91552250|NCT05873556|182988713|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.16||||0.45|TWO_SIDED|95.0|0.79|1.72|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.72|0.79|0.45
91552251|NCT05873556|182988713|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.17||||0.46|TWO_SIDED|95.0|0.77|1.79|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.79|0.77|0.46
91552252|NCT05873556|182988714|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.62|TWO_SIDED|95.0|0.77|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.17|0.77|0.62
91552253|NCT05873556|182988714|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.14||||0.34|TWO_SIDED|95.0|0.87|1.48|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.48|0.87|0.34
91767320|NCT00255190|183423952|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.102
91552254|NCT05873556|182988715|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.08||||0.66|TWO_SIDED|95.0|0.76|1.54|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.54|0.76|0.66
91552255|NCT05873556|182988715|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.75|0.92
91552256|NCT04484428|182988716|SUPERIORITY|||||||0.773|||||||ANCOVA|||||||0.773
91552257|NCT04484428|182988717|SUPERIORITY|||||||0.972|||||||ANCOVA|||||||0.972
91552258|NCT04484428|182988718|SUPERIORITY|||||||0.617|||||||ANCOVA|||||||0.617
91552259|NCT04484428|182988719|SUPERIORITY|||||||0.796|||||||ANCOVA|||||||0.796
91552260|NCT04484428|182988720|SUPERIORITY|||||||0.96|||||||ANCOVA|||||||0.960
91552261|NCT04484428|182988721|SUPERIORITY|||||||0.761|||||||ANCOVA|||||||0.761
91552262|NCT04484428|182988722|SUPERIORITY|||||||0.979|||||||ANCOVA|||||||0.979
91552263|NCT04484428|182988723|SUPERIORITY|||||||0.803|||||||ANCOVA|||||||0.803
91552264|NCT00661141|182988726|SUPERIORITY|||||||0.8727||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.8727
91552265|NCT00661141|182988729|SUPERIORITY|||||||0.0023||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.0023
91552266|NCT00661141|182988729|SUPERIORITY|||||||0.386||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort||||0.386
91552267|NCT00661141|182988729|SUPERIORITY|||||||0.0006||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg, 5.0 mg/kg||||0.0006
91552268|NCT00661141|182988729|SUPERIORITY|||||||0.0154||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||3.0 mg/kg, 5.0 mg/kg||||0.0154
91552269|NCT00661141|182988736|SUPERIORITY||ratio of parameter means|115.57|||||TWO_SIDED|90.0|90.45|147.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||147.67|90.45|
91552270|NCT00661141|182988736|SUPERIORITY||ratio of parameter means|126.05|||||TWO_SIDED|90.0|101.94|155.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||155.87|101.94|
91552271|NCT00661141|182988736|SUPERIORITY||ratio of parameter means|137.58|||||TWO_SIDED|90.0|115.66|163.65|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.65|115.66|
91552272|NCT00661141|182988736|SUPERIORITY||ratio of parameter means|82.4|||||TWO_SIDED|90.0|62.83|108.07|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||108.07|62.83|
91552273|NCT00661141|182988736|SUPERIORITY||ratio of parameter means|115.25|||||TWO_SIDED|90.0|91.19|145.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||145.67|91.19|
91552274|NCT00661141|182988736|SUPERIORITY||ratio of parameter means|112.64|||||TWO_SIDED|90.0|96.14|131.98|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||131.98|96.14|
91552275|NCT00661141|182988739|SUPERIORITY||ratio of parameter means|139.63|||||TWO_SIDED|90.0|92.18|211.51|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||211.51|92.18|
91552276|NCT00661141|182988739|SUPERIORITY||ratio of parameter means|120.76|||||TWO_SIDED|90.0|108.8|134.03|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||134.03|108.80|
91552277|NCT00661141|182988739|SUPERIORITY||ratio of parameter means|143.39|||||TWO_SIDED|90.0|107.72|190.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||190.87|107.72|
91552278|NCT00661141|182988739|SUPERIORITY||ratio of parameter means|103.13|||||TWO_SIDED|90.0|84.35|126.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||126.10|84.35|
91552279|NCT00661141|182988739|SUPERIORITY||ratio of parameter means|123.17|||||TWO_SIDED|90.0|108.61|139.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||139.67|108.61|
91552280|NCT00661141|182988739|SUPERIORITY||ratio of parameter means|137.17|||||TWO_SIDED|90.0|123.3|152.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||152.59|123.30|
91552281|NCT00661141|182988741|SUPERIORITY||ratio of parameter means|121.81|||||TWO_SIDED|90.0|108.42|136.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||136.84|108.42|
91552282|NCT00661141|182988741|SUPERIORITY||ratio of parameter means|123.7|||||TWO_SIDED|90.0|93.55|163.56|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.56|93.55|
91552283|NCT00661141|182988741|SUPERIORITY||ratio of parameter means|150.33|||||TWO_SIDED|90.0|93.14|242.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||242.63|93.14|
91552284|NCT00661141|182988741|SUPERIORITY||ratio of parameter means|122.83|||||TWO_SIDED|90.0|82.45|183.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analysis for Cohort 3 where all available data were included.||183.00|82.45|
91552285|NCT00661141|182988747|SUPERIORITY||ratio of parameter means|69.13|||||TWO_SIDED|90.0|48.88|97.78|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||97.78|48.88|
91552286|NCT00661141|182988747|SUPERIORITY||ratio of parameter means|124.46|||||TWO_SIDED|90.0|88.77|174.5|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||174.50|88.77|
91552287|NCT00661141|182988747|SUPERIORITY||ratio of parameter means|105.31|||||TWO_SIDED|90.0|89.24|124.27|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||124.27|89.24|
91552288|NCT00661141|182988747|SUPERIORITY||ratio of parameter means|88.6|||||TWO_SIDED|90.0|56.66|138.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||138.54|56.66|
91552289|NCT00661141|182988747|SUPERIORITY||ratio of parameter means|70.77|||||TWO_SIDED|90.0|34.16|146.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||146.59|34.16|
91552290|NCT00661141|182988747|SUPERIORITY||ratio of parameter means|86.04|||||TWO_SIDED|90.0|55.78|132.73|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||132.73|55.78|
91552291|NCT00661141|182988750|SUPERIORITY||ratio of parameter means|90.2|||||TWO_SIDED|90.0|69.54|117.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||117.00|69.54|
91552292|NCT00661141|182988750|SUPERIORITY||ratio of parameter means|112.28|||||TWO_SIDED|90.0|103.72|121.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||121.54|103.72|
91552293|NCT00661141|182988750|SUPERIORITY||ratio of parameter means|106.08|||||TWO_SIDED|90.0|96.81|116.24|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||116.24|96.81|
91552294|NCT00661141|182988750|SUPERIORITY||ratio of parameter means|104.12|||||TWO_SIDED|90.0|83.5|129.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||129.84|83.50|
91552295|NCT00661141|182988750|SUPERIORITY||ratio of parameter means|100.41|||||TWO_SIDED|90.0|77.86|129.49|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||129.49|77.86|
91552296|NCT00661141|182988750|SUPERIORITY||ratio of parameter means|94.7|||||TWO_SIDED|90.0|82.7|108.42|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||108.42|82.70|
91552297|NCT00661141|182988752|SUPERIORITY||ratio of parameter means|94.15|||||TWO_SIDED|90.0|78.01|1113.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||1113.63|78.01|
91767321|NCT00255190|183423953|SUPERIORITY_OR_OTHER|||||||0.656||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.656
91767322|NCT00255190|183423954|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.176
91552298|NCT00661141|182988752|SUPERIORITY||ratio of parameter means|107.05|||||TWO_SIDED|90.0|87.42|131.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||131.10|87.42|
91552299|NCT00661141|182988752|SUPERIORITY||ratio of parameter means|97.9|||||TWO_SIDED|90.0|84.84|112.97|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||112.97|84.84|
91552300|NCT03221426|182988904|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.01501|TWO_SIDED|95.0|0.67|0.98||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.98|0.67|0.01501
91552301|NCT03221426|182988905|SUPERIORITY||Difference in Percentage|11.4|||<|1e-05|TWO_SIDED|95.0|8.0|15.3|||Stratified Miettinen and Nurminen|Based on Miettinen \& Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)||||15.3|8.0|<0.00001
91552302|NCT03221426|182988906|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07503|TWO_SIDED|95.0|0.71|1.06||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||1.06|0.71|0.07503
91552303|NCT03221426|182988911|OTHER||Hazard Ratio (HR)|0.82||||0.04125|TWO_SIDED|95.0|0.65|1.03||One-sided p-value based on log-rank test with stratification|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification|||1.03|0.65|0.04125
91552304|NCT03221426|182988912|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.04493|TWO_SIDED|95.0|0.71|1.03||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|||1.03|0.71|0.04493
91552305|NCT03221426|182988913|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.00589|TWO_SIDED|95.0|0.67|0.95||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.95|0.67|0.00589
91552306|NCT06262477|182988914|EQUIVALENCE|The natural log (ln)- transformed Cmax was analysed using analysis of covariance (ANCOVA) model, which included actual treatment \& body weight category (\<75 kilograms \[kg\], ≥75 kg) as factors. The ratio of geometric least square means (GLSM), and corresponding confidence interval (CI) was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.05|||||TWO_SIDED|90.3|0.974|1.13||||||||1.13|0.974|
91552307|NCT06262477|182988915|EQUIVALENCE|The natural log (ln)- transformed AUC0-inf was analyzed using ANCOVA model, which included actual treatment \& body weight category (\<75 kg, ≥75 kg) as factors. The ratio of GLSM, and corresponding CI was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.07|||||TWO_SIDED|90.3|0.988|1.15||||||||1.15|0.988|
91552308|NCT06262477|182988916|EQUIVALENCE|The natural log (ln)- transformed AUC0-t was analyzed using ANCOVA model, which included actual treatment \& body weight category (\<75 kg, ≥75 kg) as factors. The ratio of GLSM, and corresponding CI was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.06|||||TWO_SIDED|90.3|0.985|1.15||||||||1.15|0.985|
91552309|NCT05365958|182988933|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
91767323|NCT00255190|183423955|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.030
91767324|NCT00255190|183423956|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.243
91552310|NCT05365958|182988934|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
91552311|NCT05618587|182989039|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91552312|NCT05618587|182989040|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
91552313|NCT05618587|182989041|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
91552314|NCT05618587|182989042|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
91552315|NCT05618587|182989043|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
91552316|NCT05618587|182989044|SUPERIORITY|||||||1|||||||Barnard unconditional exact test|||||||1.0
91552317|NCT05618587|182989045|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
91552318|NCT05618587|182989046|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91552319|NCT05618587|182989047|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91552320|NCT05618587|182989048|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
91552321|NCT05618587|182989049|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
91552322|NCT05618587|182989050|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
91552323|NCT05167864|182989052|SUPERIORITY|||||||0.13519|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.13519
91552324|NCT05167864|182989052|SUPERIORITY|||||||0.8556|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.8556
91552325|NCT05167864|182989052|SUPERIORITY|||||||0.46943|TWO_SIDED|95.0|||||Wilcoxon signed-rank test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.46943
91552326|NCT05167864|182989052|SUPERIORITY|||||||0.0449|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.0449
91552327|NCT05167864|182989052|SUPERIORITY|||||||0.504|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.504
91552328|NCT05167864|182989052|SUPERIORITY|||||||0.772193|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.772193
91552329|NCT05167864|182989052|SUPERIORITY|||||||0.5414|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.5414
91552330|NCT05167864|182989052|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.070
91552331|NCT05167864|182989052|SUPERIORITY|||||||0.546|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.546
91552332|NCT05167864|182989052|SUPERIORITY|||||||0.756|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.756
91552333|NCT05167864|182989052|SUPERIORITY|||||||0.7|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.700
91552334|NCT05167864|182989052|SUPERIORITY|||||||0.397|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.397
91552335|NCT05167864|182989052|SUPERIORITY|||||||0.093|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.093
91552336|NCT05167864|182989052|SUPERIORITY|||||||0.323|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.323
91552337|NCT05167864|182989052|SUPERIORITY|||||||0.182|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement of line in the forehead post injection day 180|||0.182
91552338|NCT05167864|182989052|SUPERIORITY|||||||0.88|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.880
91552339|NCT05167864|182989052|SUPERIORITY|||||||0.496|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement in the forehead post injection day 3|||0.496
91552340|NCT05167864|182989052|SUPERIORITY|||||||0.905|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.905
91552341|NCT05167864|182989052|SUPERIORITY|||||||0.692|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.692
91552342|NCT05167864|182989052|SUPERIORITY|||||||0.262|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.262
91767325|NCT00255190|183423957|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.005
91767326|NCT00255190|183423958|SUPERIORITY_OR_OTHER|||||||0.469||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.469
91767327|NCT00628030|183423961|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||.008
91767328|NCT00628030|183423962|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Chi-squared|||||||.041
91767329|NCT00628030|183423963|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|||||||.61
91552343|NCT05167864|182989052|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.828
91552344|NCT05167864|182989052|SUPERIORITY|||||||0.268|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.268
91552345|NCT05167864|182989052|SUPERIORITY|||||||0.975|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.975
91552346|NCT05167864|182989052|SUPERIORITY|||||||0.499|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.499
91767330|NCT00628030|183423964|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
91552347|NCT05167864|182989052|SUPERIORITY|||||||0.75|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.750
91552348|NCT05167864|182989052|SUPERIORITY|||||||0.433|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.433
91552349|NCT05167864|182989052|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
91552350|NCT05167864|182989052|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
91552351|NCT05167864|182989052|SUPERIORITY|||||||0.526|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.526
91552352|NCT05167864|182989052|SUPERIORITY|||||||0.816|TWO_SIDED|95.0|||||Wilcoxon singed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.816
91767331|NCT00628030|183423965|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||.024
91767332|NCT02366195|183423980|OTHER|||||||0.387|||||||Regression, Logistic|||||||0.387
91552353|NCT05167864|182989052|SUPERIORITY|||||||0.65|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.650
91552354|NCT05167864|182989052|SUPERIORITY|||||||0.095|TWO_SIDED|95.0|||||wilcoxon rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.095
91552355|NCT05167864|182989052|SUPERIORITY|||||||0.618|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.618
91552356|NCT05167864|182989052|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.340
91552357|NCT05167864|182989052|SUPERIORITY|||||||0.15|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.150
91552358|NCT05167864|182989052|SUPERIORITY|||||||0.361|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.361
91552359|NCT05167864|182989052|SUPERIORITY|||||||0.428|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.428
91552360|NCT05167864|182989052|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.834
91552361|NCT05167864|182989052|SUPERIORITY|||||||0.318|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.318
91767333|NCT02366195|183423981|OTHER|Primary completion data.||||||0.056|||||||Regression, Logistic|||||||0.056
91767334|NCT02366195|183423981|OTHER|Final analysis data.||||||0.222|||||||Regression, Logistic|||||||0.222
91552362|NCT05167864|182989052|SUPERIORITY|||||||0.311|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.311
91552363|NCT05167864|182989052|SUPERIORITY|||||||0.885|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.885
91552364|NCT05167864|182989052|SUPERIORITY|||||||0.457|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.457
91552365|NCT05167864|182989052|SUPERIORITY|||||||0.745|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.745
91552366|NCT05167864|182989052|SUPERIORITY|||||||0.757|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.757
91552367|NCT05167864|182989052|SUPERIORITY|||||||0.562|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.562
91767335|NCT02366195|183423982|OTHER|Primary completion data||||||0.335|||||||Cox proportional hazards|||||||0.335
91767336|NCT02366195|183423982|OTHER|Final analysis data||||||0.597|||||||Cox proportional hazards|||||||0.597
91767337|NCT02366195|183423983|OTHER|Primary completion||||||0.82|||||||Fisher's Z transformation|||||||0.82
91767338|NCT02366195|183423983|OTHER|Final analysis data||||||0.9|||||||Fisher's Z transformation|||||||0.90
91767339|NCT02366195|183423984|OTHER|Primary completion data||||||0.66|||||||Regression, Logistic|||||||0.660
91552368|NCT05167864|182989052|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.828
91552369|NCT05167864|182989052|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.005
91552370|NCT05167864|182989052|SUPERIORITY|||||||0.437|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.437
91552371|NCT03314688|182989071|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.69
91552372|NCT03314688|182989072|SUPERIORITY|||||||0.33|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.33
91552373|NCT03314688|182989072|SUPERIORITY|||||||0.44|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.44
91552374|NCT03314688|182989072|SUPERIORITY|||||||0.29|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.29
91767340|NCT02366195|183423984|OTHER|Final analysis data||||||0.881|||||||Regression, Logistic|||||||0.881
91767341|NCT02366195|183423985|OTHER|Primary completion data||||||0.974|||||||Regression, Logistic|||||||0.974
91552375|NCT03314688|182989073|SUPERIORITY|||||||0.69|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.69
91552376|NCT03314688|182989073|SUPERIORITY|||||||0.91|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.91
91552377|NCT03314688|182989073|SUPERIORITY|||||||0.13|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.13
91552378|NCT01828112|182989131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.36|0.67|||Log Rank|||||0.67|0.36|<0.001
91552379|NCT05565820|182989184|SUPERIORITY||difference in proportions|-0.335|STANDARD_ERROR_OF_MEAN|0.149||0.025|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 2.246 Cohen's d: .590|Direction of comparison: Vamousse Day 2 proportion of live lice - Nix Day 2 proportion of live lice|"Null hypothesis: At Day 2 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.025
91552380|NCT05565820|182989184|SUPERIORITY||Difference in proportions|0.348|STANDARD_ERROR_OF_MEAN|0.141||0.014|TWO_SIDED|||||Alpha: .05.|Z-test for difference in proportions|Z 2.469 Cohen's d .660|Direction of comparison: Vamousse Day 7 proportion live lice free - Nix Day 7 proportion live lice free|"Null hypothesis: At Day 7 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.014
91552381|NCT05565820|182989184|SUPERIORITY||Difference in proportions|0.283|STANDARD_ERROR_OF_MEAN|0.147||0.054|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 1.920 Cohen's d: .513|Vamousse Day 14 proportion live lice free - Nix Day 14 proportion live lice free|"Null hypothesis: At Day 14 the proportion of lice-free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.054
91552382|NCT05565820|182989185|SUPERIORITY|"To check on the effect of the non-normality of the change proportions, the nonparametric Mann-Whitney test was also performed.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.1148||0.02|TWO_SIDED|95.0|0.052|0.537||Alpha = .05 t: 2.567 df (adjusted, see comment below): 16.83 Mann-Whitney Z: 2.830 p(2-tailed) of Mann-Whitney Z: .005 Cohen's d = 1.023|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.83|Direction of comparison: Vamousse prop. reduction in live lice count from Day O - Nix prop. reduction in live lice count from Day O|"Null hypothesis: At Day 2 the mean proportion of decrease from Day 0 in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 2 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.537|.052|.020
91767342|NCT02366195|183423985|OTHER|Final analysis data||||||0.612|||||||Regression, Logistic|||||||0.612
91767343|NCT02366195|183423986|OTHER|Primary completion data||||||0.626|||||||Cox proportional hazards|||||||0.626
91767344|NCT02366195|183423986|OTHER|Final analysis data||||||0.579|||||||Cox proportional hazards|||||||0.579
91767345|NCT02366195|183423987|OTHER|Primary completion data||||||0.18|||||||Pearson's correlation coefficient|||||||0.18
91767346|NCT02366195|183423987|OTHER|Final analysis data||||||0.14|||||||Pearson's correlation coefficient|||||||0.14
91767347|NCT02119871|183423995|SUPERIORITY||Median Difference (Final Values)|14.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
91767348|NCT02119871|183423996|SUPERIORITY||Median Difference (Final Values)|10.0||||0.656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.656
91767349|NCT02119871|183423997|SUPERIORITY||Median Difference (Final Values)|4.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
91767350|NCT03324802|183424013|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
91767351|NCT03324802|183424014|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
91767352|NCT03324802|183424016|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.320
91552383|NCT05565820|182989185|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.182||0.334|TWO_SIDED|95.0|-0.187|0.543||Alpha = .05 t: .976 df: 54 Mann-Whitney Z: 3.021 p(2-tailed) of Mann-Whitney Z: .003 Cohen's d = .294|t-test, 2 sided|Levine's test for violation of equality of variances nonsignificant; no df adjustment necessary.||"Null hypothesis: At Day 7 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 7 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on their mean change proportions."||.543|-.187|.334
91552384|NCT05565820|182989185|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Difference between proportions|0.235|STANDARD_ERROR_OF_MEAN|0.1034||0.037|TWO_SIDED|95.0|0.016|0.454||Alpha = .05 t: 2.276 df(adjusted, see comment below): 16.2 Mann-Whitney Z: 2.478 p(2-tailed) of Mann-Whitney Z: .013 Cohen's d = .947|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.2||"Null hypothesis: At Day 14 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 14 change proportion deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.454|.016|.037
91552385|NCT04047602|182989186|EQUIVALENCE|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.|Binomial Proportion|0.083||||0.234|TWO_SIDED|95.0|0.002|0.385||The p-value reported is the one-sided p-value from the exact equivalence binomial test using an alpha value of 0.05.|Exact Binomial Test||The binomial proportion 95% confidence intervals were calculated using the Clopper-Pearson (Exact) method.|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.||0.385|0.002|0.234
91552386|NCT04047602|182989189|OTHER|||||||0.285|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.285
91552387|NCT04047602|182989190|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
91552388|NCT04047602|182989191|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
91552389|NCT04047602|182989194|OTHER|||||||0.248|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.248
91552390|NCT04047602|182989195|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
91552391|NCT04047602|182989196|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
91552392|NCT05828017|182989224|SUPERIORITY||Mean Difference (Final Values)|1.107|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
91552393|NCT05828017|182989224|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.015|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference between Variation #1 and the standard curve in terms of mean preference counts per participant.||||0.015
91552394|NCT05828017|182989225|SUPERIORITY||Mean Difference (Final Values)|1.039|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
91767353|NCT03324802|183424017|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
91767354|NCT03324802|183424018|SUPERIORITY|||||||0.97|||||||Log Rank|||||||0.97
91767355|NCT03324802|183424019|SUPERIORITY|||||||0.5|||||||Gray Test P-value|||||||0.5
91767356|NCT03324802|183424020|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
91767357|NCT02673918|183424039|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91767358|NCT02673918|183424040|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
91767359|NCT01708317|183424052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.001||||||We used a cutoff of P\<0.05 as statistically significant.|Chi-squared|3 degrees of freedom to compare 4 time periods.||We compared testing in the 4 time frames described, including the time frame in which we enrolled patients in the ACASI.||||<.001
91767360|NCT01787461|183424058|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.14||||0.358|TWO_SIDED|95.0|-0.16|0.44|||ANOVA|||Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.44|-0.16|0.358
91552395|NCT05828017|182989225|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.03569|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.03569
91552396|NCT05828017|182989226|SUPERIORITY||Mean Difference (Final Values)|0.365||||0.069|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||0.069
91552397|NCT05828017|182989226|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.6976|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.6976
91552398|NCT05828017|182989227|SUPERIORITY||Mean Difference (Final Values)|0.876|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
91552399|NCT05828017|182989227|SUPERIORITY||Mean Difference (Final Values)|0.728||||0.0013|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.0013
91552400|NCT05828017|182989228|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.522|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.522
91552401|NCT05828017|182989228|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.27|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts between the standard curve and variation #1.||||0.27
91552402|NCT05828017|182989229|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.28|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.28
91552403|NCT05828017|182989229|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.11|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.11
91552404|NCT05828017|182989230|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.52|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.52
91552405|NCT05828017|182989230|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.26|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.26
91552406|NCT05828017|182989231|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.16|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.16
91552407|NCT05828017|182989231|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.37|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.37
91552408|NCT05828017|182989232|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.08
91552409|NCT05828017|182989232|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.31|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.31
91552410|NCT05828017|182989233|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.21|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.21
91767361|NCT01787461|183424059|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.037||||0.568|TWO_SIDED|95.0|-0.19|0.27|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.||0.27|-0.19|0.568
91552411|NCT05828017|182989233|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.085|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.085
91552412|NCT05828017|182989234|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.86
91552413|NCT05828017|182989234|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||1
91552414|NCT05828017|182989235|SUPERIORITY||Mean Difference (Final Values)|0.607||||0.009|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.009
91552415|NCT05828017|182989235|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.61|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.61
91552416|NCT05828017|182989236|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.11|1.0|||ANOVA|||This is to see if there is a difference in mean SRT50 scores between the standard curve, variation #1, and no preference counts.||1.00|0.11|<0.001
91552417|NCT05828017|182989236|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.357|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in SRT 50 scores between the standard curve and variation #1.||1|0|0.357
91767362|NCT01787461|183424060|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.797|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-0.25|0.797
91552418|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.7|||<|0.01|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2, #3, and #4||||<0.01
91552419|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.01||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #3.||||0.94
91552420|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.014||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #4||||0.94
91552421|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.45||||0.017|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2, #3, and #4||||0.017
91552422|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.51||||0.02|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #3.||||0.02
91552423|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.61||||0.006|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #4||||0.006
91552424|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.6|||<|0.0001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2, #3, and #4||||<.0001
91552425|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.38||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #3||||0.08
91552426|NCT05828017|182989237|SUPERIORITY||Total Count - Cramer's V|0.5|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #4||||<0.001
91552427|NCT05419830|182989238|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep time dip in systolic BP. Analysis was adjusted for baseline value of the outcome||||||0.65|||||||ANCOVA|||||||0.65
91552428|NCT05419830|182989239|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in nocturia frequency. Analysis was adjusted for baseline value of the outcome||||||0.66|||||||ANCOVA|||||||0.66
91552429|NCT05419830|182989240|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in NPi. Analysis was adjusted for baseline value of the outcome||||||0.14|||||||ANCOVA|||||||0.14
91552430|NCT05419830|182989241|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in PSQI scores. Analysis was adjusted for baseline value of the outcome||||||0.2|||||||ANCOVA|||||||0.2
91552431|NCT05419830|182989242|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep efficiency. Analysis was adjusted for baseline value of the outcome||||||0.02|||||||ANCOVA|||||||0.02
91552432|NCT05012163|182989243|SUPERIORITY|||||||0.506||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket and patients sent messages offering $1 cash in exchange for vaccination; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent messages offering $1 cash.||||.506
91552433|NCT05012163|182989243|SUPERIORITY|||||||0.378||||||Comments: Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent active control messages.||||0.378
91552434|NCT05012163|182989243|SUPERIORITY||||||<|0.001||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those who were not sent messages.||||<.001
91767363|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.965|TWO_SIDED|95.0|-0.29|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.29|0.965
91767364|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.674|TWO_SIDED|95.0|-0.2|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.20|0.674
91767365|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.916|TWO_SIDED|95.0|-0.35|0.32|||ANOVA|||Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.35|0.916
91767366|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.915|TWO_SIDED|95.0|-0.39|0.35|||ANOVA|||Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.35|-0.39|0.915
91767367|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.672|TWO_SIDED|95.0|-0.4|0.26|||ANOVA|||Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.26|-0.40|0.672
91767368|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.655|TWO_SIDED|95.0|-0.27|0.43|||ANOVA|||Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.27|0.655
91767369|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.23|0.43|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.23|0.561
91767370|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.356|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.40|-0.14|0.356
91767371|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.669|TWO_SIDED|95.0|-0.28|0.43|||ANOVA|||Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.28|0.669
91767372|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.954|TWO_SIDED|95.0|-0.32|0.34|||ANOVA|||Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.34|-0.32|0.954
91552435|NCT05012163|182989243|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent active control messages and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent active control messages compared to those who were not sent messages.||||<.001
91552436|NCT05012163|182989243|SUPERIORITY|Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.||||||0.121|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those sent active control messages.||||.121
91552437|NCT05012163|182989243|SUPERIORITY|||||||0.002||||||Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those who were not sent messages.||||.002
91552438|NCT02567409|182989251|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.69|1.98|||||Hazard ratio relative to arm B.|||1.98|0.69|
91552439|NCT02567409|182989252|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.71|2.48|||||Hazard ratio relative to arm B.|||2.48|0.71|
91552440|NCT02567409|182989253|SUPERIORITY|||||||0.51|||||||Fisher Exact|||||||0.51
91552441|NCT00670241|182989373|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|2.05|5.7|||Cochran-Mantel-Haenszel|||||5.70|2.05|< 0.001
91552442|NCT00670241|182989374|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|98.33|1.46|8.4|||Cochran-Mantel-Haenszel|||||8.40|1.46|<0.001
91767373|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.684|TWO_SIDED|95.0|-0.34|0.22|||ANOVA|||Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.22|-0.34|0.684
91552443|NCT00670241|182989375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|98.33|-22.6|-6.9|||ANOVA|||||-6.90|-22.6|<0.001
91767374|NCT01787461|183424061|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.886|TWO_SIDED|95.0|-0.35|0.3|||ANOVA|||Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.35|0.886
91767375|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.901|TWO_SIDED|95.0|-0.33|0.37|||ANOVA|||Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.37|-0.33|0.901
91552444|NCT03213873|182989430|SUPERIORITY||Interaction effect time x group|0.4||||0.57|TWO_SIDED|95.0|-1.0|1.9|||Mixed Models Analysis|||||1.9|-1.0|0.57
91552445|NCT03213873|182989431|SUPERIORITY||Interaction effect time x group|0.05||||0.25|TWO_SIDED|95.0|-0.03|0.12|||Mixed Models Analysis|||||0.12|-0.03|0.25
91552446|NCT03213873|182989432|SUPERIORITY||Interaction effect time x group|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
91552447|NCT02361216|182989451|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.29|||<|0.001|TWO_SIDED|95.0|2.82|14.0|||Cochran-Mantel-Haenszel|||AKclear100 at Week 8: full analysis set. The null hypothesis was that there is no difference at Week 8 in AKclear100 rates between ingenol mebutate gel 0.027% and vehicle gel. This hypothesis was tested against the 2-sided alternative of a difference between the 2 treatment groups.||14|2.82|<0.001
91552448|NCT02361216|182989452|SUPERIORITY||Ratio of clearance rates|6.81|||<|0.001|TWO_SIDED|95.0|4.16|11.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate (0.027% relative to vehicle), adjusted for pooled sites|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||11.1|4.16|<0.001
91767376|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.399|TWO_SIDED|95.0|-0.19|0.47|||ANOVA|||Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.47|-0.19|0.399
91552449|NCT02361216|182989453|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.53|||<|0.001|TWO_SIDED|95.0|4.04|10.5|||Mantel Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The pre-specified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.5|4.04|<0.001
91552450|NCT02361216|182989454|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance|0.28|||<|0.001|TWO_SIDED|95.0|0.24|0.32||Negative binominal regression with log baseline count as offset variable and treatment group, anatomical location stratum and pooled site as factors.|Cochran-Mantel-Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.24|<0.001
91767377|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.38|0.32|||ANOVA|||Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.38|0.875
91552451|NCT05683340|182989458|SUPERIORITY||Least squares mean difference|-21.78|STANDARD_ERROR_OF_MEAN|2.482||0.001|TWO_SIDED|95.0|-26.71|-16.85|||MMRM||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-16.85|-26.71|0.001
91552452|NCT03505008|182989475|NON_INFERIORITY|Two-sided 90% CI for the intergroup difference in SDAI remission rates to exceed the non-inferiority margin of -15%|Risk Difference (RD)|0.0|||||TWO_SIDED|90.0||||||||||||
91552453|NCT02056834|182989518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.0166
91552454|NCT02056834|182989519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.3785
91552455|NCT02056834|182989520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
91552456|NCT02056834|182989521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
91767378|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.005|TWO_SIDED|95.0|0.13|0.73|||ANOVA|||Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.73|0.13|0.005
91552457|NCT03687762|182989575|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91767379|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.876|TWO_SIDED|95.0|-0.33|0.38|||ANOVA|||Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.33|0.876
91552458|NCT03687762|182989576|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552459|NCT03687762|182989577|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552460|NCT03687762|182989578|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552461|NCT03687762|182989579|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552462|NCT03687762|182989580|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.||||||0.01|||||||ANOVA|||||||0.01
91552463|NCT03687762|182989581|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552464|NCT03687762|182989582|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552465|NCT03687762|182989583|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
91552466|NCT03687762|182989584|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552467|NCT03687762|182989585|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552468|NCT03687762|182989586|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552469|NCT03687762|182989587|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91767380|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.789|TWO_SIDED|95.0|-0.29|0.38|||ANOVA|||Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.29|0.789
91552470|NCT03687762|182989588|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552471|NCT03687762|182989589|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552472|NCT03687762|182989590|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
91552473|NCT03825588|182989608|SUPERIORITY|||||||0.71||||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of actual suicide attempts||||0.71
91552474|NCT03825588|182989608|SUPERIORITY|||||||0.43||||||False Discovery Rate q-vale \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of actual suicide attempts||||0.43
91767381|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.901|TWO_SIDED|95.0|-0.31|0.38|||ANOVA|||Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.31|0.901
91767382|NCT01787461|183424062|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.027|TWO_SIDED|95.0|0.04|0.72|||ANOVA|||Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.72|0.04|0.027
91767383|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.083||||0.688|TWO_SIDED|95.0|-0.1|0.27|||Cochran-Mantel-Haenszel|||Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.27|-0.10|0.688
91767384|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.121||||0.445|TWO_SIDED|95.0|-0.08|0.33|||Cochran-Mantel-Haenszel|||Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.33|-0.08|0.445
91767385|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.318|TWO_SIDED|95.0|0.01|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.01|0.318
91767386|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.012||||0.633|TWO_SIDED|95.0|-0.15|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.15|0.633
91552475|NCT03825588|182989608|SUPERIORITY||Odds Ratio (OR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.66||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.66|0.10|0.21
91767387|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.018||||0.996|TWO_SIDED|95.0|-0.23|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.23|0.996
91552476|NCT03825588|182989608|SUPERIORITY||Odds Ratio (OR)|1.31||||0.57|TWO_SIDED|95.0|0.51|3.34||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of ASAP||3.34|0.51|0.57
91552477|NCT03825588|182989608|SUPERIORITY||Odds Ratio (OR)|1.15||||0.77|TWO_SIDED|95.0|0.44|2.97||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of BRITE.||2.97|0.44|0.77
91552478|NCT03825588|182989608|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.48|1.69||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on time to actual suicide attempt||1.69|0.48|0.74
91767388|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.059||||0.432|TWO_SIDED|95.0|-0.13|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.13|0.432
91767389|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.03||||0.833|TWO_SIDED|95.0|-0.13|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.13|0.833
91767390|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.226||||0.171|TWO_SIDED|95.0|0.06|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.06|0.171
91767391|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.02||||0.796|TWO_SIDED|95.0|-0.16|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.16|0.796
91552479|NCT03825588|182989608|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.45|TWO_SIDED|95.0|0.42|1.48||False Discovery Rate q-vale \> 0.99|Regression, Cox|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the time to actual suicide attempt||1.48|0.42|0.45
91552480|NCT03825588|182989608|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.25|TWO_SIDED|95.0|0.13|1.72||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Interaction effect of ASAP and BRITE||1.72|0.13|0.25
91552481|NCT03825588|182989608|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.62|TWO_SIDED|95.0|0.54|2.87||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.87|0.54|0.62
91552482|NCT03825588|182989608|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.83|TWO_SIDED|95.0|0.47|2.59||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||2.59|0.47|0.83
91552483|NCT03825588|182989609|SUPERIORITY|||||||0.19||||||False Discovery Rate q-value = 0.72|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of suicidal events|We used standard univariate statistics to compare partici- pants' baseline sociodemographics and clinical characteris- tics by arm \[(ASAP vs No ASAP where comparison is 6 www.jaacap.org (ASAP+TAU) and (ASAP+BRITE+TAU) vs (TAU alone) and (BRITE+TAU); and BRITE vs No BRITE where comparison is (ASAP+BRITE+TAU) and (BRITE+TAU) vs (ASAP+TAU) and (TAU Alone)\], site, retention, pre- post-COVID and recruitment venue. We then tested for equality of the 2 cells (ASAP vs no ASAP, BRITE vs no BRITE) or 4 cells (ASAP+BRITE+TAU vs BRITE +TAU vs ASAP+TAU vs TAU Alone) without covariates on the rates of and time to suicidal behavior using the appropriate (t or F, c2, Kaplan-Meier, Cox models) test statistics. We then used mixed-effects regression models with arm (2 and 4 cells), time, and their interaction for continuous data. Presented percentages are based on all observed data.|||0.19
91552484|NCT03825588|182989609|SUPERIORITY|||||||0.89|TWO_SIDED|95.0||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal events||||0.89
91552485|NCT03825588|182989609|SUPERIORITY||Odds Ratio (OR)|0.35||||0.08|TWO_SIDED|95.0|0.11|1.1||False Discovery Rate q-value = 0.72|Regression, Logistic|||Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.10|0.11|0.08
91552486|NCT03825588|182989609|SUPERIORITY||Odds Ratio (OR)|1.14||||0.74|TWO_SIDED|95.0|0.51|2.55||False Discovery Rate q \> 0.99|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.55|0.51|0.74
91552487|NCT03825588|182989609|SUPERIORITY||Odds Ratio (OR)|1.69||||0.19|TWO_SIDED|95.0|0.77|3.69||False Discovery Rate q=0.72|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||3.69|0.77|0.19
91552488|NCT05586490|182989702|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.6375||||0.429|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|Paired samples t-test, df = 7||||||0.429
91552489|NCT05586490|182989703|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|3.75||||0.351|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.351
91552490|NCT05586490|182989704|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.013||||0.937|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.937
91552491|NCT05586490|182989705|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-14.8||||0.044|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.044
91552492|NCT05586490|182989706|SUPERIORITY||Mean Difference (Net)|-0.68||||0.42|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.42
91552493|NCT05586490|182989706|SUPERIORITY||Mean Difference (Net)|0.57||||0.5|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device group and no device group) controlling for pre-trial measurements, gender, and age.||||||0.50
91552494|NCT05586490|182989707|SUPERIORITY||Mean Difference (Net)|-0.03||||0.986|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.986
91552495|NCT05586490|182989707|SUPERIORITY||Mean Difference (Net)|-1.25||||0.479|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.479
91552496|NCT05586490|182989708|SUPERIORITY||Mean Difference (Net)|-0.195||||0.098|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.098
91552497|NCT05586490|182989708|SUPERIORITY||Mean Difference (Net)|-0.039||||0.729|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.729
91552498|NCT05586490|182989709|SUPERIORITY||Mean Difference (Net)|-8.15||||0.058|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.0580
91552499|NCT05586490|182989709|SUPERIORITY||Mean Difference (Net)|-1.54||||0.718|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.718
91552500|NCT05586490|182989711|SUPERIORITY||Mean Difference (Net)|0.063||||0.816|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.816
91552501|NCT05586490|182989711|SUPERIORITY||Mean Difference (Net)|-0.0048||||0.985|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.985
91552502|NCT05586490|182989712|SUPERIORITY||Mean Difference (Net)|6.33||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.59
91552503|NCT05586490|182989712|SUPERIORITY||Mean Difference (Net)|8.16||||0.51|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.51
91552504|NCT05290493|182989749|SUPERIORITY|||||||0.0672|||||||Mixed Models Analysis|||||||0.0672
91552505|NCT05290493|182989750|SUPERIORITY|||||||0.2045|||||||Mixed Models Analysis|||||||0.2045
91552506|NCT05290493|182989751|SUPERIORITY|||||||0.2931|||||||Mixed Models Analysis|||||||0.2931
91552507|NCT05290493|182989752|SUPERIORITY|||||||0.7799|||||||Mixed Models Analysis|||||||0.7799
91552508|NCT05290493|182989753|SUPERIORITY|||||||0.7974|||||||Mixed Models Analysis|||||||0.7974
91552509|NCT05290493|182989754|SUPERIORITY|||||||0.8286|||||||Mixed Models Analysis|||||||0.8286
91552510|NCT05062330|182989763|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.67|4.13|||Generalized estimating equation|||||4.13|1.67|<0.0001
91552511|NCT05280574|182989824|OTHER||Ratio of geometric means|0.75|||<|0.05|TWO_SIDED|95.0|0.51|1.1|||Distinct-effects GEE model||Average relative effect of unblinded versus blinded monitoring across the 5-component composite (SpO2 \<85%, RR \>30/min, RR \<4/min, HR \<45/min, HR \>130/min) of cumulative durations.||We assessed the treatment effect of unblinded versus blinded monitoring across the 5-component primary outcome composite of cumulative durations by estimating the average relative effect on the log-transformed count data (counts of observations beyond a given threshold at 1 Hz). Specifically, we employed a distinct-effects (i.e., separate treatment effect estimated for each component) generalized estimating equation (GEE) model to account for within-subject correlation across components with the vector of the 5 cumulative durations as the dependent variable and treatment as independent. We then averaged the component-specific effects and tested whether the average effect equals zero (on the log scale), and reported results as the ratio of geometric means of unblinded versus blinded monitoring.|1.1|0.51|< 0.05
91552512|NCT05363163|182989827|OTHER|If the mean volume variation was higher than 0 and the p-value of the statistical test lower than 0.05, the H0 hypothesis was rejected, and the primary endpoint demonstrated.|||||<|0.0001||||||p-value of the statistical test lower than 0.05|t-test, 2 sided|||||||<0.0001
91552513|NCT03154190|182989844|SUPERIORITY||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.2|0.47|||Regression, Cox|||||0.47|0.20|
91552514|NCT03154190|182989845|SUPERIORITY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.3|0.75|||Regression, Cox|||||0.75|0.30|
91552515|NCT03154190|182989848|SUPERIORITY||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.33|0.62||||||||0.62|0.33|
91552516|NCT03154190|182989850|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.36|0.7||||||||0.70|0.36|
91552517|NCT03154190|182989855|SUPERIORITY||Odds Ratio (OR)|4.46|||||TWO_SIDED|95.0|1.88|10.55||||||||10.55|1.88|
91552518|NCT03673501|182989858|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3598|TWO_SIDED|95.0|0.66|1.16|||Log Rank|Strata: by intolerance to imatinib treatment||||1.16|0.66|0.3598
91552519|NCT03673501|182989859|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7153|TWO_SIDED|95.0|0.82|1.33||Two-sided P-value|Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||1.33|0.82|0.7153
91552520|NCT03673501|182989860|SUPERIORITY|||||||0.0333|||||||Cochran-Mantel-Haenszel|Strata: intolerance to imatinib treatment||||||0.0333
91552521|NCT03673501|182989861|SUPERIORITY|||||||0.2681|||||||Cochran-Mantel-Haenszel|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||||0.2681
91552522|NCT03673501|182989862|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7733|TWO_SIDED|95.0|0.75|1.48|||Log Rank|Strata: intolerance to imatinib treatment||||1.48|0.75|0.7733
91552523|NCT03673501|182989863|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3928|TWO_SIDED|95.0|0.66|1.18|||Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib||||1.18|0.66|0.3928
91552524|NCT05838027|182989864|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|0.84|12.55||||||||12.55|0.84|
91552525|NCT05838027|182989865|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.24|2.64||||||||2.64|0.24|
91552526|NCT05838027|182989866|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.52|||||TWO_SIDED|95.0|-3.78|4.82||||||||4.82|-3.78|
91552527|NCT05838027|182989867|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.01|1.4||||||||1.40|-1.01|
91767392|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.033||||0.942|TWO_SIDED|95.0|-0.23|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.23|0.942
91552528|NCT05838027|182989868|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-2.71|||||TWO_SIDED|95.0|-7.43|2.0||||||||2.00|-7.43|
91552529|NCT05838027|182989869|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-5.45|4.16||||||||4.16|-5.45|
91552530|NCT05838027|182989870|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|1.12|||||TWO_SIDED|95.0|0.46|2.74||||||||2.74|0.46|
91552531|NCT05838027|182989871|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.75|||||TWO_SIDED|95.0|-1.29|-0.21||||||||-0.21|-1.29|
91552532|NCT05838027|182989874|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.57|||||TWO_SIDED|95.0|-1.9|3.03||||||||3.03|-1.90|
91767393|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.118||||0.405|TWO_SIDED|95.0|-0.05|0.28|||Cochran-Mantel-Haenszel|||Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.28|-0.05|0.405
91767394|NCT01787461|183424063|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.061||||0.687|TWO_SIDED|95.0|-0.14|0.26|||Cochran-Mantel-Haenszel|||Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.26|-0.14|0.687
91767395|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.384||||0.017|TWO_SIDED|95.0|0.23|0.54|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.54|0.23|0.017
91767396|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.248||||0.073|TWO_SIDED|95.0|0.09|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.09|0.073
91552533|NCT05838027|182989875|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.32|0.58||||||||0.58|-0.32|
91552534|NCT05838027|182989876|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|0.62|||||TWO_SIDED|95.0|0.23|1.63||||||||1.63|0.23|
91552535|NCT05838027|182989877|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|1.05|||||TWO_SIDED|95.0|-0.54|2.64||||||||2.64|-0.54|
91767397|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.057||||0.117|TWO_SIDED|95.0|-0.11|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.11|0.117
91767398|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.096||||0.662|TWO_SIDED|95.0|-0.31|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.31|0.662
91552536|NCT05838027|182989878|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.19|5.49||||||||5.49|0.19|
91552537|NCT05838027|182989879|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.64|0.43||||||||0.43|-2.64|
91552538|NCT05838027|182989880|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|2.72|||||TWO_SIDED|95.0|-1.35|6.8||||||||6.80|-1.35|
91552539|NCT05838027|182989881|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.69|||||TWO_SIDED|95.0|-1.74|0.36||||||||0.36|-1.74|
91552540|NCT05237284|182989882|SUPERIORITY|||||||0.6999|||||||Wilcoxon (Mann-Whitney)|||CAFS at Week 24 was analyzed using the Wilcoxon-Mann-Whitney test to compare mean scores between the treatment groups at Week 24.||||0.6999
91552541|NCT05237284|182989885|SUPERIORITY||LS Mean Difference|0.52||||0.2182|TWO_SIDED|95.0|-0.31|1.35|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline NfL, disease duration-by-visit interaction, and baseline ALSFRS-R score-by-visit interaction.||1.350|-0.310|0.2182
91552542|NCT05237284|182989886|SUPERIORITY||LS Mean Difference|0.419||||0.8134|TWO_SIDED|95.0|-3.075|3.914|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline SVC, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction, and baseline SVC-by-visit interaction.||3.914|-3.075|0.8134
91552543|NCT05237284|182989887|SUPERIORITY||Ratio of the LS Geometric Mean Ratios|0.961||||0.2356|TWO_SIDED|95.0|0.899|1.027|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, log transformed baseline NfL, disease duration-by-visit interaction, and log transformed baseline NfL-by-visit interaction.||1.027|0.899|0.2356
91552544|NCT05237284|182989888|SUPERIORITY||LS Mean difference|-0.005||||0.9565|TWO_SIDED|95.0|-0.193|0.183|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline megascore, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline megascore-by-visit interaction.||0.183|-0.193|0.9565
91552545|NCT05237284|182989893|SUPERIORITY||Least Square (LS) Mean Difference|-0.414||||0.5289|TWO_SIDED|95.0|-1.706|0.878|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline serum neurofilament light chain (NfL), disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline ALSFRS-R score-by-visit interaction.||0.878|-1.706|0.5289
91552546|NCT05237284|182989894|SUPERIORITY|||||||0.183|||||||ANCOVA|||Analysis was performed using rank analysis of covariance (ANCOVA) model including treatment group, randomization strata of the geographic region of the study site, ALS onset region (bulbar or other areas), use of riluzole (yes or no), use of edaravone (yes or no), use of the combination of sodium phenylbutyrate and taurursodiol (yes or no), disease duration (from first symptom onset to the screening visit), baseline ALSFRS-R score and baseline NfL.||||0.1830
91552547|NCT06029452|182989967|NON_INFERIORITY|Non-inferiority margin was 0.10.|Sensitivity|0.853|||||ONE_SIDED|95.0|0.815||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.815|
91552548|NCT06029452|182989967|NON_INFERIORITY|Non-inferiority margin was 0.10.|Specificity|0.584|||||ONE_SIDED|95.0|0.539||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.539|
91552549|NCT05552508|182989981|OTHER|||||||0.0327|||||||t-test, 2 sided|||All participants||||0.0327
91552550|NCT05552508|182989981|OTHER|||||||0.0359|||||||t-test, 2 sided|||Participants with \>=4 mucus plugs||||0.0359
91552551|NCT05552508|182989981|OTHER|||||||0.1088|||||||t-test, 2 sided|||Participants with \<4 mucus plugs||||0.1088
91552552|NCT05552508|182989981|OTHER|||||||0.0391|||||||t-test, 2 sided|||Non-OCS-dependent participants||||0.0391
91552553|NCT05552508|182989982|OTHER|||||||0.0423|||||||t-test, 2 sided|||||||0.0423
91552554|NCT05552508|182989983|OTHER|||||||0.9465|||||||t-test, 2 sided|||||||0.9465
91767399|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.1||||0.373|TWO_SIDED|95.0|-0.05|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.05|0.373
91552555|NCT05552508|182989984|OTHER|||||||0.3455|||||||t-test, 2 sided|||||||0.3455
91552556|NCT05552508|182989985|OTHER|||||||0.2484|||||||t-test, 2 sided|||||||0.2484
91552557|NCT05552508|182989986|OTHER|||||||0.9405|||||||t-test, 2 sided|||||||0.9405
91552558|NCT05552508|182989987|OTHER|||||||0.6867|||||||t-test, 2 sided|||||||0.6867
91552559|NCT05552508|182989988|OTHER|||||||0.7554|||||||t-test, 2 sided|||||||0.7554
91552560|NCT03421340|182990045|NON_INFERIORITY|Non-Inferiority Margin of 10%|Risk Difference (RD)|1.8||||0.029|TWO_SIDED||||||exact|||||||0.029
91552561|NCT03421340|182990046|SUPERIORITY|Not powered|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-8.0|4.1||||||||4.1|-8|
91552562|NCT03421340|182990047|SUPERIORITY||Median Difference (Net)|133.0|||||TWO_SIDED|95.0|120.0|143.0||||||||143|120|
91552563|NCT03421340|182990048|SUPERIORITY||Median Difference (Final Values)|-10.2|||||TWO_SIDED|95.0|-11.6|-7.5||||||||-7.5|-11.6|
91552564|NCT01199133|182990049|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01|||>|0.05||95.0|-0.41|0.43|||ANCOVA|||||0.43|-0.41|> 0.05
91552565|NCT02575950|182990050|SUPERIORITY||Mean Difference (Final Values)|-9.34|||<|0.001|TWO_SIDED|95.0|-14.71|-3.96|||ANCOVA|||Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.||-3.96|-14.71|<.001
91552566|NCT03106740|182990098|SUPERIORITY|Because relevant \[11C\]PBR28 PET imaging data were unavailable at the time of trial initiation to inform a power analysis of a treatment effect, we ran a power analysis of the treatment effect on the expected change in pain ratings based on a recent clinical trial using minocycline in subjects with back pain. We computed the sample size required for mixed effects between-subject and within-subject (Time: Pretest/Posttest) repeated measures ANOVA design. Alpha was set at 0.05 (two-tailed test).|Restricted maximum likelihood|0.0||||0.956|TWO_SIDED|95.0|-0.02|0.02||The p-value corresponds to the group-by-time interaction analysis of the primary outcome measure.|Mixed Models Analysis||Estimation parameter: Unstandardized partial regression coefficient (beta)|||0.02|-0.02|0.956
91552567|NCT04797858|182990101|SUPERIORITY||Risk Difference (RD)|0.0077||||0.45|TWO_SIDED|95.0|-0.021|0.056|||Fisher Exact|||||0.056|-0.021|0.45
91552568|NCT04797858|182990102|SUPERIORITY||Risk Difference (RD)|0.015||||0.11|TWO_SIDED|95.0|-0.0004|0.03|||Fisher Exact|||||0.03|-0.0004|0.11
91552569|NCT01880515|182990109|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.17|0.99||||||||0.99|0.17|
91552570|NCT01880515|182990112|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.41
91552571|NCT04359654|182990133|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91552572|NCT04359654|182990134|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91552573|NCT04359654|182990136|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
91552574|NCT04359654|182990137|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|||The reported LS means are antilogs of the LS means estimated on the log scale.||||0.021
91552575|NCT03677141|182990173|SUPERIORITY||Difference in rates|-4.77|||||TWO_SIDED|95.0|-30.61|21.07||||||||21.07|-30.61|
91552576|NCT06193070|182990226|OTHER|A one-tailed paired t-test was run to examine within subject mean difference on the cancer nutrition information beliefs scale pre- and post-game.|||||<|0.001||||||The threshold was set at alpha \< 0.05.|t-test, 1 sided|A paired samples t-test was run on pre- and post-game mean scores within subjects.||All participants were exposed to the intervention, and pre- and post-game scores within subject were examined.||||<.001
91552577|NCT03583333|182990238|NON_INFERIORITY|Non-inferiority margin for the difference in mortality (IMI/REL minus PIP/TAZ) was 12.5%.|Adjusted difference in percentage|5.2||||0.024|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen method||Adjusted differences and the 95% confidence intervals (CIs) are based on Miettinen \& Nurminen method stratified by randomization stratum.|||12.4|-1.5|0.024
91552578|NCT03583333|182990238|SUPERIORITY||Adjusted difference in percentage|5.2||||0.938|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen|Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.||||12.4|-1.5|0.938
91552579|NCT03583333|182990239|OTHER||Adjusted difference in percentage|3.1|||||TWO_SIDED|95.0|-8.7|14.9|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.9|-8.7|
91552580|NCT03583333|182990240|OTHER||Adjusted difference in percentage|2.2|||||TWO_SIDED|95.0|-12.4|16.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||16.8|-12.4|
91552581|NCT03583333|182990241|OTHER||Adjusted difference in percentage|3.4|||||TWO_SIDED|95.0|-7.6|14.3|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.3|-7.6|
91552582|NCT03583333|182990242|OTHER||Adjusted difference in percentage|-4.7|||||TWO_SIDED|95.0|-15.8|6.6|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||6.6|-15.8|
91552583|NCT03583333|182990243|OTHER||Adjusted difference in percentage|-2.4|||||TWO_SIDED|95.0|-17.8|13.1|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||13.1|-17.8|
91552584|NCT03583333|182990244|OTHER||Adjusted difference in percentage|1.4|||||TWO_SIDED|95.0|-16.5|19.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||19.8|-16.5|
91767400|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.031||||0.294|TWO_SIDED|95.0|-0.19|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.19|0.294
91552585|NCT03583333|182990245|OTHER||Adjusted difference in percentage|-3.1|||||TWO_SIDED|95.0|-19.8|14.4|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.4|-19.8|
91767401|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.035||||0.857|TWO_SIDED|95.0|-0.2|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.20|0.857
91767402|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.206||||0.088|TWO_SIDED|95.0|0.02|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.02|0.088
91767403|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.193||||0.11|TWO_SIDED|95.0|-0.02|0.41|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.41|-0.02|0.110
91552586|NCT03583333|182990246|OTHER||Adjusted difference in percentage|2.0|||||TWO_SIDED|95.0|-6.5|10.6|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||10.6|-6.5|
91767404|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.112|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.34|0.07|0.112
91552587|NCT03583333|182990247|OTHER||Adjusted difference in percentage|-4.4|||||TWO_SIDED|95.0|-10.7|1.4|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||1.4|-10.7|
91552588|NCT03926130|182990248|SUPERIORITY||Risk Difference (RD)|28.7|||<|1e-06|TWO_SIDED|95.0|23.0|34.4|||Cochran-Mantel-Haenszel|||||34.4|23.0|<0.000001
91552589|NCT03926130|182990249|SUPERIORITY||Risk Difference (RD)|25.8|||<|1e-06|TWO_SIDED|95.0|18.8|32.7|||Cochran-Mantel-Haenszel|||||32.7|18.8|<0.000001
91767405|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.003||||0.614|TWO_SIDED|95.0|-0.13|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.13|0.614
91767406|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.011||||0.693|TWO_SIDED|95.0|-0.18|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.18|0.693
91552590|NCT03926130|182990250|SUPERIORITY||Risk Difference (RD)|19.7|||<|1e-06|TWO_SIDED|95.0|13.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|13.7|<0.000001
91552591|NCT03926130|182990251|SUPERIORITY||Risk Difference (RD)|39.1|||<|1e-06|TWO_SIDED|95.0|33.4|44.8|||Cochran-Mantel-Haenszel|||||44.8|33.4|<0.000001
91552592|NCT03926130|182990251|SUPERIORITY||Risk Difference (RD)|2.3||||0.513623|TWO_SIDED|95.0|-4.7|9.3|||Cochran-Mantel-Haenszel|||||9.3|-4.7|0.513623
91552593|NCT03926130|182990252|SUPERIORITY||Risk Difference (RD)|12.4||||0.001431|TWO_SIDED|95.0|5.3|19.6|||Cochran-Mantel-Haenszel|||||19.6|5.3|0.001431
91552594|NCT03926130|182990253|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|27.7|41.4|||Cochran-Mantel-Haenszel|||||41.4|27.7|<0.000001
91552595|NCT03926130|182990253|NON_INFERIORITY|The non-inferiority margin is 10%. We do not have power calculation in the SAP for this endpoint.|Risk Difference (RD)|5.7|||<|0.0001|TWO_SIDED|95.0|-1.4|12.8|||Z test|||||12.8|-1.4|<0.0001
91552596|NCT03926130|182990254|SUPERIORITY||Risk Difference (RD)|6.8||||0.003414|TWO_SIDED|95.0|3.2|10.5|||Cochran-Mantel-Haenszel|||||10.5|3.2|0.003414
91552597|NCT03926130|182990255|SUPERIORITY||LSMean Difference (Net)|-0.86||||1.1e-05|TWO_SIDED|95.0|-1.24|-0.48|||ANCOVA|||||-0.48|-1.24|0.000011
91552598|NCT03926130|182990256|SUPERIORITY||LSMean Difference (Net)|-2.01|||<|1e-06|TWO_SIDED|95.0|-2.42|-1.6|||ANCOVA|||||-1.60|-2.42|<0.000001
91552599|NCT03926130|182990257|SUPERIORITY||Risk Difference (RD)|25.7|||<|1e-06|TWO_SIDED|95.0|18.9|32.6|||Cochran-Mantel-Haenszel|||||32.6|18.9|<0.000001
91552600|NCT03926130|182990258|SUPERIORITY||Risk Difference (RD)|13.8|||<|1e-06|TWO_SIDED|95.0|10.2|17.4|||Cochran-Mantel-Haenszel|||||17.4|10.2|<0.000001
91552601|NCT03926130|182990259|SUPERIORITY||Risk Difference (RD)|25.0|||<|1e-06|TWO_SIDED|95.0|18.2|31.8|||Cochran-Mantel-Haenszel|||||31.8|18.2|<0.000001
91552602|NCT03926130|182990260|SUPERIORITY||LSMean Difference (Net)|-0.85|||<|1e-06|TWO_SIDED|95.0|-1.05|-0.65|||ANCOVA|||||-0.65|-1.05|<0.000001
91552603|NCT03926130|182990261|SUPERIORITY||LSMean Difference (Net)|-1.22|||<|1e-06|TWO_SIDED|95.0|-1.48|-0.95|||ANCOVA|||||-0.95|-1.48|<0.000001
91552604|NCT03926130|182990262|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91552605|NCT03926130|182990263|SUPERIORITY||Risk Difference (RD)|4.1||||0.732715|TWO_SIDED|95.0|-18.0|26.1|||Cochran-Mantel-Haenszel|||||26.1|-18.0|0.732715
91552606|NCT03926130|182990264|SUPERIORITY||LSMean Difference (Net)|27.92|||<|1e-06|TWO_SIDED|95.0|22.67|33.18|||ANCOVA|||||33.18|22.67|<0.000001
91552607|NCT03926130|182990266|SUPERIORITY||Risk Difference (RD)|10.6||||0.000213|TWO_SIDED|99.5|4.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|4.1|0.000213
91552608|NCT03926130|182990267|SUPERIORITY||Risk Difference (RD)|19.4|||<|1e-06|TWO_SIDED|99.5|13.1|25.7|||Cochran-Mantel-Haenszel|||||25.7|13.1|<0.000001
91552609|NCT01866163|182990269|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|30.27|||<|0.001|TWO_SIDED|95.0|9.72|94.3|||Mantel Haenszel|||Multiple imputations were used to handle missing data.||94.30|9.72|<0.001
91552610|NCT01866163|182990270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.28|||<|0.001|TWO_SIDED|95.0|-3.9|-2.67|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-2.67|-3.90|<0.001
91552611|NCT01866163|182990271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.76|-0.78|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-0.78|-1.76|<0.001
91552612|NCT03580356|182990288|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|9.029|||<|0.0001|TWO_SIDED|95.0|3.183|25.615|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||25.615|3.183|<.0001
91552613|NCT03580356|182990288|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.926||||0.6646|TWO_SIDED|95.0|0.65|1.319|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.319|0.650|0.6646
91552614|NCT03580356|182990288|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|11.508|||<|0.0001|TWO_SIDED|95.0|4.058|32.638|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||32.638|4.058|<.0001
91552615|NCT03580356|182990288|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|1.181||||0.173|TWO_SIDED|95.0|0.836|1.667|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.667|0.836|0.1730
91552616|NCT03580356|182990289|SUPERIORITY||LS Mean|-9.997|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-12.554|-7.439|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-7.439|-12.554|<.0001
91552617|NCT03580356|182990289|SUPERIORITY||LS mean|0.414|STANDARD_ERROR_OF_MEAN|0.922||0.6735|TWO_SIDED|95.0|-1.392|2.221|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||2.221|-1.392|0.6735
91552618|NCT03580356|182990289|SUPERIORITY||LS Mean|-11.091|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-13.664|-8.518|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-8.518|-13.664|<.0001
91767407|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.079||||0.762|TWO_SIDED|95.0|-0.06|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.06|0.762
91552619|NCT03580356|182990289|SUPERIORITY||LS mean|-0.68|STANDARD_ERROR_OF_MEAN|0.923||0.2305|TWO_SIDED|95.0|-2.489|1.128|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||1.128|-2.489|0.2305
91552620|NCT03580356|182990291|SUPERIORITY||LS Mean|-4.105|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.281|-2.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||-2.929|-5.281|<.0001
91552621|NCT03580356|182990291|SUPERIORITY||LS Mean|0.101|STANDARD_ERROR_OF_MEAN|0.422||0.5943|TWO_SIDED|95.0|-0.727|0.928|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.928|-0.727|0.5943
91552622|NCT03580356|182990291|SUPERIORITY|Adults only|LS Mean|-4.496|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-5.678|-3.314|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-3.314|-5.678|<.0001
91552623|NCT03580356|182990291|SUPERIORITY||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.423||0.2467|TWO_SIDED|95.0|-1.12|0.54|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.540|-1.120|0.2467
91552624|NCT03580356|182990293|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.443|||<|0.0001|TWO_SIDED|95.0|1.955|6.063|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||6.063|1.955|<.0001
91767408|NCT01787461|183424064|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.013||||0.662|TWO_SIDED|95.0|-0.16|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.16|0.662
91767409|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|3.93||||0.587|TWO_SIDED|95.0|-10.32|18.18|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||18.18|-10.32|0.587
91552625|NCT03580356|182990293|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.838||||0.8524|TWO_SIDED|95.0|0.602|1.167|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.167|0.602|0.8524
91552626|NCT03580356|182990293|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|4.542|||<|0.0001|TWO_SIDED|95.0|2.577|8.004|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||8.004|2.577|<.0001
91552627|NCT03580356|182990293|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|1.106||||0.2764|TWO_SIDED|95.0|0.794|1.54|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.540|0.794|0.2764
91552628|NCT03580356|182990294|SUPERIORITY||Risk Ratio (RR)|1.389|||<|0.0001|TWO_SIDED|95.0|1.235|1.561|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.561|1.235|<.0001
91552629|NCT03580356|182990294|SUPERIORITY||Risk Ratio (RR)|1.029||||0.2369|TWO_SIDED|95.0|0.952|1.111|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.111|0.952|0.2369
91552630|NCT03580356|182990294|SUPERIORITY||Risk Ratio (RR)|1.425|||<|0.0001|TWO_SIDED|95.0|1.268|1.603|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.603|1.268|<.0001
91552631|NCT03580356|182990294|SUPERIORITY||Risk Ratio (RR)|1.056||||0.083|TWO_SIDED|95.0|0.978|1.14|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.140|0.978|0.0830
91552632|NCT05715528|182990296|SUPERIORITY||Hazard Ratio (HR)|1.099||||0.0681|TWO_SIDED|95.0|0.997|1.211||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% confidence interval (CI) for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.211|0.997|0.0681
91552633|NCT05715528|182990300|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.5558|TWO_SIDED|95.0|0.935|1.147|||Stratified Log-Rank Test|P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.147|0.935|0.5558
91767410|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.08||||0.814|TWO_SIDED|95.0|-14.49|12.32|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||12.32|-14.49|0.814
91552634|NCT05715528|182990301|SUPERIORITY|||||||0.6469|||||||Fisher's exact test|||||||0.6469
91552635|NCT05715528|182990302|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.5581|TWO_SIDED|95.0|0.045|5.464|||Log-rank test|P value was based on log-rank test.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression.|||5.464|0.045|0.5581
91552636|NCT05715528|182990304|SUPERIORITY||Least Squares Mean|0.02||||0.4254|TWO_SIDED|95.0|-0.03|0.08||p-value was from Mixed-effects model repeated measures (MMRM) with baseline viral load and randomization strata as covariates.|MMRM||95% CI was from MMRM with baseline viral load and randomization strata as covariates.|||0.08|-0.03|0.4254
91552637|NCT05715528|182990305|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.0015|TWO_SIDED|95.0|1.032|1.256||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.256|1.032|0.0015
91552638|NCT05715528|182990306|SUPERIORITY|||||||0.6978|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.6978
91552639|NCT05715528|182990311|SUPERIORITY|||||||0.5707|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.5707
91552640|NCT03331835|182990312|SUPERIORITY||Risk Difference (RD)|42.86|||<|0.001|TWO_SIDED|95.0|30.93|54.79|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg).||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||54.79|30.93|<0.001
91552641|NCT03331835|182990313|SUPERIORITY||Risk Difference (RD)|44.76|||<|0.001|TWO_SIDED|95.0|32.81|56.71|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg)||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||56.71|32.81|<0.001
91552642|NCT03331835|182990314|SUPERIORITY||Risk Difference (RD)|43.81|||<|0.001|TWO_SIDED|95.0|31.78|55.84|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||55.84|31.78|<0.001
91552643|NCT03331835|182990315|SUPERIORITY||Risk Difference (RD)|31.43|||<|0.001|TWO_SIDED|95.0|20.76|42.1|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||42.10|20.76|<0.001
91552644|NCT03331835|182990316|SUPERIORITY||Mean Difference (Net)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.83|-1.33|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-1.33|-4.83|<0.001
91552645|NCT03331835|182990317|SUPERIORITY||Mean Difference (Net)|-16.36|||<|0.001|TWO_SIDED|95.0|-23.03|-9.68|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-9.68|-23.03|<0.001
91552646|NCT03331835|182990318|SUPERIORITY||Mean Difference (Net)|-8.91|||<|0.001|TWO_SIDED|95.0|-13.0|-4.81|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-4.81|-13.00|<0.001
91552647|NCT03331835|182990322|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.001|TWO_SIDED|95.0|-6.31|-3.53|||ANCOVA|||The AUC was analysed using analysis of covariance (ANCOVA) with treatment group, baseline weight group, and the baseline PSI total score as explanatory variables. Treatment groups are defined as randomised treatment.||-3.53|-6.31|<0.001
91552648|NCT03331835|182990323|SUPERIORITY||Mean Difference (Net)|-2.57||||0.004|TWO_SIDED|95.0|-4.32|-0.82|||Mixed Models Analysis|||The endpoint is analysed by using mixed model for repeated measurements (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups are defined as randomised treatment.||-0.82|-4.32|0.004
91552649|NCT03331835|182990324|SUPERIORITY|Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (\<=100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|Risk Difference (RD)|40.95|||<|0.001|TWO_SIDED|95.0|28.75|53.16|||Cochran-Mantel-Haenszel|||||53.16|28.75|<0.001
91552650|NCT03331835|182990325|SUPERIORITY|The endpoint was analysed by using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|Mean Difference (Net)|-1.72||||0.028|TWO_SIDED|95.0|-3.24|-0.19|||Mixed Models Analysis|||||-0.19|-3.24|0.028
91552651|NCT04204083|182990339|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91552652|NCT04204083|182990340|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91552653|NCT04204083|182990341|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
91552654|NCT05736458|182990427|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.66|TWO_SIDED||||||t-test, 2 sided|||Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis. Statistics are from paired 2 tailed t-test comparing pre-rTMS 2-back percent accuracy scores for participant's high and low controllability target.||||0.66
91552655|NCT05736458|182990428|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.43|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from 2-tailed t-test comparing pre-rTMS to post-rTMS 2-back accuracy scores for a high controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||0.43
91767411|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.57||||0.453|TWO_SIDED|95.0|-16.14|8.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||8.99|-16.14|0.453
91767412|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.16||||0.191|TWO_SIDED|95.0|-22.92|4.61|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.61|-22.92|0.191
91767413|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.685|TWO_SIDED|95.0|-10.07|15.28|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.28|-10.07|0.685
91552656|NCT05736458|182990428|SUPERIORITY||Mean Difference (Final Values)|6.36|||<|0.04|TWO_SIDED||||||t-test, 2 sided|df = 20||Statistics are from 2-tailed t-test comparing pre-rTMS and post-rTMS 2-back percent accuracy scores for a low controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||<0.04
91552657|NCT05736458|182990429|SUPERIORITY||Mean Difference (Final Values)|11.54|||<|0.05|TWO_SIDED||||||t-test, 2 sided|df = 11||Statistics are from 2-tailed paired t-test comparing 2-back accuracy score before and after rTMS to a high controllability target. Alternative hypothesis: true mean is not equal to 0.||||<0.05
91552658|NCT05736458|182990430|SUPERIORITY||Mean Difference (Net)|-4.42||||0.27|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from paired 2 tailed t-test comparing 2-back percent changes (Post-rTMS - pre-rTMS) scores for participant's high and low controllability target. Alternative hypothesis: true mean is not equal to 0.||||0.27
91552659|NCT04011644|182990431|SUPERIORITY|||||||0.688|||||||Mixed Models Analysis|Quanbeck,A.et al. A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder. npj Digit. Med.7,248(2024)||||||0.688
91552660|NCT04011644|182990432|SUPERIORITY|||||||0.261|||||||Mixed Models Analysis|||||||0.261
91552661|NCT04011644|182990433|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
91552662|NCT04011644|182990435|SUPERIORITY|||||||0.908|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.908
91552663|NCT04011644|182990437|SUPERIORITY|||||||0.206|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.206
91552664|NCT04011644|182990438|SUPERIORITY|||||||0.104|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.104
91767414|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|5.74||||0.48|TWO_SIDED|95.0|-11.67|23.15|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||23.15|-11.67|0.480
91552665|NCT04011644|182990439|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91552666|NCT04011644|182990440|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||0.025
91552667|NCT04011644|182990441|SUPERIORITY|||||||0.555|||||||Mixed Models Analysis|||||||0.555
91552668|NCT04011644|182990442|SUPERIORITY|||||||0.131|||||||Kruskal-Wallis|||||||0.131
91552669|NCT04011644|182990446|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
91552670|NCT04271046|182990527|OTHER|||||||0.97|||||||Regression, Linear|||||||0.97
91552671|NCT04271046|182990528|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
91552672|NCT04271046|182990529|OTHER|||||||0.26|||||||Regression, Linear|||||||0.26
91552673|NCT04271046|182990530|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
91552674|NCT04271046|182990537|OTHER|||||||0.08|||||||Regression, Linear|||||||0.08
91767415|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.98||||0.299|TWO_SIDED|95.0|-17.29|5.34|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||5.34|-17.29|0.299
91767416|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.07||||0.107|TWO_SIDED|95.0|-20.04|1.9|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.90|-20.04|0.107
91767417|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82||||0.776|TWO_SIDED|95.0|-14.39|10.76|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||10.76|-14.39|0.776
91767418|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.33||||0.603|TWO_SIDED|95.0|-15.96|9.29|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||9.29|-15.96|0.603
91767419|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82||||0.51|TWO_SIDED|95.0|-15.23|7.6|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||7.60|-15.23|0.510
91552675|NCT04271046|182990538|OTHER|||||||0.79|||||||Regression, Linear|||||||0.79
91552676|NCT04271046|182990539|OTHER|||||||0.6|||||||Regression, Linear|||||||0.60
91552677|NCT04271046|182990540|OTHER|||||||0.86|||||||Regression, Linear|||||||0.86
91552678|NCT04271046|182990541|OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
91552679|NCT04271046|182990542|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
91552680|NCT04271046|182990543|OTHER|||||||0.63|||||||Regression, Linear|||||||0.63
91552681|NCT04271046|182990544|OTHER|||||||0.28|||||||Regression, Linear|||||||0.28
91552682|NCT04271046|182990545|OTHER|||||||0.82|||||||Regression, Linear|||||||0.82
91552683|NCT04271046|182990546|OTHER|||||||0.04|||||||Regression, Linear|||||||0.04
91552684|NCT04271046|182990547|OTHER|||||||0.98|||||||Regression, Linear|||||||0.98
91552685|NCT04271046|182990548|OTHER|||||||0.22|||||||Regression, Linear|||||||0.22
91552686|NCT04271046|182990549|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
91552687|NCT04271046|182990550|OTHER|||||||0.8|||||||Regression, Linear|||||||0.80
91552688|NCT01570361|182990589|SUPERIORITY|||||||0.0009||||||Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.|Log Rank|One-sided test||||||0.0009
91552689|NCT01570361|182990590|SUPERIORITY|||||||0.0118||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0118
91552690|NCT01570361|182990591|SUPERIORITY|||||||0.0041||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0041
91552691|NCT05513937|182990617|SUPERIORITY||Mean difference pre vs post|-15.2|STANDARD_DEVIATION|8.32|<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||||||<0.001
91552692|NCT02846545|182990619|SUPERIORITY||Least Square (LS) Mean|-0.178|||=|0.0004|TWO_SIDED|95.0|-0.28|-0.08|||Mixed Models Analysis|||||-0.08|-0.28|= 0.0004
91552693|NCT02846545|182990620|SUPERIORITY||LS Mean|-0.09|||=|0.802|TWO_SIDED|95.0|-0.81|0.63|||Mixed Models Analysis|||||0.63|-0.81|= 0.8020
91552694|NCT02846545|182990621|SUPERIORITY||Ratio of hypoglycemia rates|0.9|||=|0.0036|TWO_SIDED|95.0|0.838|0.966|||Poisson regression model|||Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.||0.966|0.838|= 0.0036
91552695|NCT06468982|182990630|SUPERIORITY|To evaluate whether intra-aortic balloon pump catheter support contributes to a more rapid decrease in troponin levels and faster myocardial recovery, daily troponin levels were analyzed using mixed ANOVA.||||||0.05||||||The p-value was adjusted for multiple comparisons, and the threshold value was set at 0.05.|ANOVA|The hypothesis that IABP causes a rapid increase in troponin levels was analyzed using ANOVA, and the p-value was reported.||After testing for normality, the baseline characteristics of the two groups will be analyzed using the Student's t-test or the Mann-Whitney U-test for continuous variables and the chi-square test or Fisher's exact test for categorical variables. Differences between the intra-aortic balloon pump group and the control group in terms of repeated measurements will be analyzed using mixed ANOVA.||||0.05
91552696|NCT06468982|182990631|OTHER||Hazard Ratio, log|0.55|||<|0.05|TWO_SIDED|95.0|0.38|0.78|||Wilcoxon (Mann-Whitney)|||The prognostic value of risk factors for in-hospital mortality was evaluated by multivariate logistic regression analysis||0.78|0.38|<0.05
91767420|NCT01787461|183424065|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.75||||0.225|TWO_SIDED|95.0|-17.7|4.2|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.20|-17.70|0.225
91767421|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.214|TWO_SIDED|95.0|-0.46|2.02|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.02|-0.46|0.214
91767422|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.027|TWO_SIDED|95.0|0.12|2.09|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.09|0.12|0.027
91552697|NCT04181736|182990632|OTHER||F-statistic|6.621||||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for circuit function, with five repeated measures for each circuit measure defining the cognitive control circuit.||||0.020
91552698|NCT04181736|182990637|OTHER||Cohen's d effect size|1.47|||<|0.001|TWO_SIDED|95.0|0.937|2.002||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to week 2.||2.002|0.937|<0.001
91767423|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99||||0.049|TWO_SIDED|95.0|0.01|1.96|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.96|0.01|0.049
91552699|NCT04181736|182990637|OTHER||Cohen's d effect size|3.152|||<|0.001|TWO_SIDED|95.0|2.757|3.547||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to post-treatment sessions.||3.547|2.757|<0.001
91552700|NCT04181736|182990638|OTHER||Cohen's d effect size|-1.249|||<|0.001|TWO_SIDED|95.0|-1.724|-0.774||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in QIDS-SR depression scores from pre-treatment to post-treatment sessions.||-0.774|-1.724|< 0.001
91552701|NCT04181736|182990639|OTHER||F-statistic|19.362|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for cognitive control function, with six repeated measures for behavioral tests of cognitive control.||||<0.001
91552702|NCT04181736|182990640|OTHER||Cohen's d effect size|0.881||||0.002|TWO_SIDED|95.0|0.324|1.438||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in SWLS scores from pre-treatment to post-treatment sessions.||1.438|0.324|0.002
91767424|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.019|TWO_SIDED|95.0|0.2|2.14|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.14|0.20|0.019
91767425|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.449|TWO_SIDED|95.0|-0.36|0.8|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.36|0.449
91552703|NCT04181736|182990641|OTHER||F-statistic|11.913||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for quality with four repeated measures for domains of quality of life.||||0.003
91552704|NCT04181736|182990642|OTHER||Cohen's d effect size|-0.2||||0.283|TWO_SIDED|95.0|-0.608|0.208||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in C-SSRS scores from pre-treatment to post-treatment sessions.||0.208|-0.608|0.283
91552705|NCT05507333|182990653|OTHER||Proportion of clinically cured patients|0.62|||||TWO_SIDED|95.0|0.4073|0.7909|||||"The proportion of clinically cured patients at Day 7-14 was calculated and presented together with a two-sided 95% CI based on the Wilson score for the proportion of Yes with continuity correction."|"It was assumed that the true clinical cure rate was 54% in the treatment group, therefore a sample size of 24 patients was needed to obtain 80% power to show that the one-sided 95% CI for the clinical cure rate was above 30%. A sample size of 26 was used to account for patients with missing data.~Hypotheses for the primary endpoint:~Null hypothesis: Clinical cure rate is less than or equal to 30%.~Alternative hypothesis (one-sided): Clinical cure rate is above 30%"||0.7909|0.4073|
91552706|NCT05507333|182990654|OTHER||Proportion with cont. clinical response|0.85|||||TWO_SIDED|95.0|0.5366|0.9729|||||"The proportion of participants with continued clinical response at Day 25 (Yes) was calculated and presented together with a two-sided 95% CI. The CI was based on the Wilson score for the proportion of Yes with a continuity correction."|||0.9729|0.5366|
91552707|NCT05507333|182990655|OTHER||Proportion with clin and mycol. cure|0.38|||||TWO_SIDED|95.0|0.2091|0.5927|||||"The proportion of participants with clinical and mycological cure at Day 7-14 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with Yes with a continuity correction."|||0.5927|0.2091|
91767426|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.105|TWO_SIDED|95.0|-0.07|0.8|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.07|0.105
91767427|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.205|TWO_SIDED|95.0|-0.14|0.68|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.68|-0.14|0.205
91552708|NCT05507333|182990656|OTHER||Proportion with mycological cure|0.54|||||TWO_SIDED|95.0|0.3375|0.7286|||||"The proportion of participants with mycological cure at Day 7-14 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with Yes with a continuity correction."|||0.7286|0.3375|
91767428|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1|TWO_SIDED|95.0|-0.06|0.77|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.77|-0.06|0.100
91552709|NCT05507333|182990657|OTHER||Proportion with mycological cure|0.77|||||TWO_SIDED|95.0|0.4598|0.9384|||||"The proportion of participants with mycological cure at Day 25 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants recorded as Yes with a continuity correction."|||0.9384|0.4598|
91552710|NCT05507333|182990658|OTHER||Proportion with absence of Candida|0.58|||||TWO_SIDED|95.0|0.3719|0.7603|||||"The proportion of participants that did not show Candida hyphae in the wet smear (absence of/Yes) at Day 7-14 was calculated and presented together with a 95% CI based on the Wilson score for the proportion of Yes with a continuity correction."|||0.7603|0.3719|
91552711|NCT05507333|182990659|OTHER||Mean Difference (Net)|-4.5|STANDARD_DEVIATION|3.15|||TWO_SIDED|95.0|-5.77|-3.23|||||The mean change in the score for composite vulvovaginal signs and symptoms from Screening to Day 7-14 was calculated and presented together with a 95% CI.|||-3.23|-5.77|
91552712|NCT05507333|182990660|OTHER||Proportion with reduction CVVS score|0.88|||||TWO_SIDED|95.0|0.6872|0.9697|||||"The proportion of participants having a reduction in signs and symptoms (CVVS scores) on Day 7-14 vs. Screening was calculated and presented with a 95% CI based on the Wilson score for the prop. with Yes with a continuity correction."|||0.9697|0.6872|
91552713|NCT01960452|182990665|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2791|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2791
91552714|NCT01960452|182990665|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.9|||||||t-test, 2 sided|||||||0.9
91552715|NCT01960452|182990666|OTHER|Group comparison, for both absolute (spatially z-score normalized across all electrodes for each subject)||||||0.1069|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.1069
91552716|NCT01960452|182990666|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.546|||||||t-test, 2 sided|||||||0.546
91552717|NCT01960452|182990667|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2918|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2918
91552718|NCT01960452|182990667|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.761|||||||t-test, 2 sided|||||||0.761
91552719|NCT04820322|182990699|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
91552720|NCT04820322|182990700|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
91552721|NCT04820322|182990701|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91767429|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.244|TWO_SIDED|95.0|-0.17|0.66|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.66|-0.17|0.244
91552722|NCT04820322|182990702|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
91552723|NCT04820322|182990703|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
91552724|NCT04820322|182990704|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
91552725|NCT04820322|182990705|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
91552726|NCT04820322|182990706|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91552727|NCT04820322|182990707|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
91552728|NCT04820322|182990708|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91552729|NCT04820322|182990709|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
91552730|NCT04934072|182990786|NON_INFERIORITY|Non-inferiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely above -1.45%.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|-0.05|0.96|||||Difference : FKS518 - US-Prolia|||0.96|-0.05|
91552731|NCT04934072|182990786|OTHER|Non-superiority Analysis: Non-superiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely below 1.45%.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|0.19|1.2|||||Difference : FKS518 - US-Prolia|||1.20|0.19|
91552732|NCT05970861|182990917|OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||"Null hypothesis: there is no statistical significance between the mean percentages of microbiota units of the main and control groups after the mare's milk administration.~Alternate hypothesis: statistical significance exists between the mean percentages of microbiota units of the main and control groups after the mare's milk administration."||||<0.05
91552733|NCT05970861|182990917|OTHER||||||<|0.05|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the mean percentages of gut microbiota units.~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the mean percentages of gut microbiota units."||||<0.05
91552734|NCT05970861|182990918|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration."||||>0.05
91552735|NCT05970861|182990919|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between uric acid blood levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between uric acid blood levels before and after the mare's milk administration."||||0.01
91552736|NCT05970861|182990920|OTHER||||||<|0.01|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration."||||<0.01
91552737|NCT05970861|182990920|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group."||||>0.05
91552738|NCT05970861|182990920|OTHER||||||<|0.01|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the scores on the scales (PCS, MCS).~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the scores on the scales (PCS, MCS)."||||<0.01
91552739|NCT02990338|182990926|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.596||||0.0005|TWO_SIDED|95.0|0.436|0.814||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.|Log Rank|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.||0.814|0.436|0.0005
91552740|NCT02990338|182990927|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|||||<|0.0001||||||Threshold for statistical significance at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.||||||<0.0001
91552741|NCT02990338|182990931|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.776||||0.0319|TWO_SIDED|95.0|0.594|1.015||One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.|Log Rank|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|||1.015|0.594|0.0319
91552742|NCT00677365|182990960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.0014|TWO_SIDED|95.0|-1.54|-0.38||Repeated Measure Model|Mixed Models Analysis|||LS Mean Difference||-0.38|-1.54|0.0014
91552743|NCT00677365|182990961|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.0007|TWO_SIDED|95.0|0.09|0.52|||Regression, Cox|||Hazard Ratio for need of anti-pseudomonal antimicrobials; Estimates are obtained from a Cox proportional hazards regression model including terms for treatment, region, baseline P.aeruginosa density (log10 ), highest baseline MIC of levofloxacin against P. aeruginosa (log2 ), and baseline percent predicted FEV1 (quartiles)||0.52|0.09|0.0007
91552744|NCT00677365|182990962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.61||||0.0026|TWO_SIDED|95.0|3.05|14.17|||Mixed Models Analysis|||LS Mean Difference Between MP-376 240 mg and Placebo groups||14.17|3.05|0.0026
91552745|NCT00677365|182990963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.94||||0.0008|TWO_SIDED|95.0|4.63|17.25|||Mixed Models Analysis|||LS Mean Difference Between Placebo and MP-376 240 mg BID groups||17.25|4.63|0.0008
91767430|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.594|TWO_SIDED|95.0|-0.32|0.56|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.56|-0.32|0.594
91767431|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.317|TWO_SIDED|95.0|-0.2|0.63|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.63|-0.20|0.317
91767432|NCT01787461|183424066|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.264|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.64|-0.17|0.264
91767433|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.16||||0.266|TWO_SIDED|95.0|-69.63|19.31|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||19.31|-69.63|0.266
91552746|NCT00677365|182990964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.2174|TWO_SIDED|95.0|-2.68|11.67|||Mixed Models Analysis|||LS Mean Difference from MP-376 240 mg BID to placebo groups||11.67|-2.68|0.2174
91552747|NCT04102111|182990993|OTHER||Least Squares Means|37.4||||0.288|TWO_SIDED|90.0|-21.0|95.8|||Mixed Model for Repeated Measures (MMRM)|||||95.8|-21.0|0.288
91767434|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.79||||0.21|TWO_SIDED|95.0|-73.99|16.41|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||16.41|-73.99|0.210
91552748|NCT03334695|182991000|SUPERIORITY|||||||0.012|||||||Wilcoxon Rank Sum test|||||||0.012
91767435|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.78||||0.753|TWO_SIDED|95.0|-56.55|40.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.99|-56.55|0.753
91767436|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.9||||0.632|TWO_SIDED|95.0|-76.32|46.51|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||46.51|-76.32|0.632
91767437|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.715|TWO_SIDED|95.0|-19.94|29.01|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.01|-19.94|0.715
91767438|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|6.35||||0.648|TWO_SIDED|95.0|-21.04|33.75|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||33.75|-21.04|0.648
91552749|NCT02542631|182991014|NON_INFERIORITY|The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.32|0.14||Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.14|-0.32|<0.0001
91552750|NCT02542631|182991015|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.25||0.26|TWO_SIDED|95.0|0.81|2.14||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||2.14|0.81|0.26
91552751|NCT02542631|182991016|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|3.36||0.38|TWO_SIDED|95.0|-9.63|3.7||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||3.70|-9.63|0.38
91552752|NCT02542631|182991017|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.99|TWO_SIDED|95.0|-0.28|0.28||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.28|-0.28|0.99
91552753|NCT02542631|182991018|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED|95.0|0.64|1.93||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||1.93|0.64|0.71
91552754|NCT02542631|182991019|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.52|TWO_SIDED|95.0|-0.12|0.24||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.||||0.24|-0.12|0.52
91552755|NCT02542631|182991020|SUPERIORITY||Mean Difference (Final Values)|9.16|STANDARD_ERROR_OF_MEAN|2.8||0.001|TWO_SIDED|95.0|3.65|14.67||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||14.67|3.65|0.001
91552756|NCT02542631|182991021|SUPERIORITY||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|2.03||0.03|TWO_SIDED|95.0|0.33|8.32||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||8.32|0.33|0.03
91767439|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.49||||0.315|TWO_SIDED|95.0|-48.81|15.83|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.83|-48.81|0.315
91767440|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|14.42||||0.402|TWO_SIDED|95.0|-19.5|48.34|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||48.34|-19.50|0.402
91552757|NCT02542631|182991022|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
91552758|NCT02641730|182991023|SUPERIORITY||Mean Difference (Final Values)|-7.69|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-11.0|-4.383|||Mixed-Model for Repeated Measures|||||-4.383|-11.000|<0.001
91552759|NCT02641730|182991023|SUPERIORITY||Mean Difference (Final Values)|-4.11|STANDARD_ERROR_OF_MEAN|1.7||0.017|TWO_SIDED|95.0|-7.468|-0.748|||Mixed-Model for Repeated Measures|||||-0.748|-7.468|0.017
91552760|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|2.19||||0.853|TWO_SIDED|95.0|-21.16|25.54||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||25.54|-21.16|0.853
91552761|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|5.04||||0.767|TWO_SIDED|95.0|-28.57|38.65||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.30|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||38.65|-28.57|0.767
91552762|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|2.84||||0.868|TWO_SIDED|95.0|-30.93|36.62||Unadjusted p-value|Mixed Models Analysis|t (df,112) = 0.17|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||36.62|-30.93|0.868
91552763|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.96|TWO_SIDED|95.0|-24.26|25.52||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.05|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||25.52|-24.26|0.960
91767441|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|12.43||||0.381|TWO_SIDED|95.0|-15.49|40.35|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.35|-15.49|0.381
91552764|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|8.42||||0.63|TWO_SIDED|95.0|-25.97|42.82||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.48|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.82|-25.97|0.630
91552765|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|7.79||||0.657|TWO_SIDED|95.0|-26.77|42.36||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.44|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.36|-26.77|0.657
91552766|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|-5.08||||0.627|TWO_SIDED|95.0|-25.72|15.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.56|-25.72|0.627
91552767|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.364|TWO_SIDED|95.0|-42.86|15.86||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.91|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.86|-42.86|0.364
91552768|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|-8.42||||0.574|TWO_SIDED|95.0|-38.0|21.15||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||21.15|-38.00|0.574
91552769|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|-5.51||||0.557|TWO_SIDED|95.0|-23.96|12.94||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.94|-23.96|0.557
91552770|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|-13.65||||0.302|TWO_SIDED|95.0|-39.64|12.35||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -1.03|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.35|-39.64|0.302
91552771|NCT02938923|182991053|SUPERIORITY||Mean Difference (Final Values)|-8.14||||0.541|TWO_SIDED|95.0|-34.33|18.06||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.61|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||18.06|-34.33|0.541
91552772|NCT02938923|182991054|SUPERIORITY||Mean Difference (Final Values)|357.72||||0.336|TWO_SIDED|95.0|-375.75|1091.19||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.97|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1091.19|-375.75|0.336
91767442|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.916|TWO_SIDED|95.0|-26.44|29.43|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.43|-26.44|0.916
91552773|NCT02938923|182991054|SUPERIORITY||Mean Difference (Final Values)|936.93||||0.09|TWO_SIDED|95.0|-147.56|2021.42||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.71|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2021.42|-147.56|0.090
91767443|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.88||||0.566|TWO_SIDED|95.0|-43.81|24.05|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||24.05|-43.81|0.566
91767444|NCT01787461|183424067|SUPERIORITY_OR_OTHER||LS Mean Difference|8.58||||0.667|TWO_SIDED|95.0|-30.78|47.94|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||47.94|-30.78|0.667
91767445|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.458|TWO_SIDED|95.0|-2.21|1.0|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.00|-2.21|0.458
91552774|NCT02938923|182991054|SUPERIORITY||Mean Difference (Final Values)|579.21||||0.297|TWO_SIDED|95.0|-515.36|1673.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.05|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1673.78|-515.36|0.297
91552775|NCT02938923|182991054|SUPERIORITY||Mean Difference (Final Values)|383.36||||0.245|TWO_SIDED|95.0|-266.06|1032.79||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1032.79|-266.06|0.245
91552776|NCT02938923|182991054|SUPERIORITY||Mean Difference (Final Values)|836.64||||0.069|TWO_SIDED|95.0|-67.04|1740.32||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1740.32|-67.04|0.069
91767446|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53||||0.497|TWO_SIDED|95.0|-2.07|1.01|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.01|-2.07|0.497
91767447|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.113|TWO_SIDED|95.0|-3.05|0.33|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-3.05|0.113
91552777|NCT02938923|182991054|SUPERIORITY||Mean Difference (Final Values)|453.28||||0.327|TWO_SIDED|95.0|-459.13|1365.68||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 0.98|Difference between changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1365.68|-459.13|0.327
91552778|NCT02938923|182991055|SUPERIORITY||Mean Difference (Final Values)|17.16||||0.934|TWO_SIDED|95.0|-391.74|426.05||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.08|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||426.05|-391.74|0.934
91552779|NCT02938923|182991055|SUPERIORITY||Mean Difference (Final Values)|562.64||||0.068|TWO_SIDED|95.0|-42.02|1167.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1167.31|-42.02|0.068
91552780|NCT02938923|182991055|SUPERIORITY||Mean Difference (Final Values)|545.49||||0.079|TWO_SIDED|95.0|-64.81|1155.79||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1155.79|-64.81|0.079
91552781|NCT02938923|182991055|SUPERIORITY||Mean Difference (Final Values)|33.73||||0.867|TWO_SIDED|95.0|-365.4|432.86||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 0.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||432.860|-365.40|0.867
91552782|NCT02938923|182991055|SUPERIORITY||Mean Difference (Final Values)|665.75||||0.02|TWO_SIDED|95.0|105.68|1225.81||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.36|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1225.81|105.68|0.020
91552783|NCT02938923|182991055|SUPERIORITY||Mean Difference (Final Values)|632.02||||0.029|TWO_SIDED|95.0|66.38|1197.66||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1197.66|66.38|0.029
91552784|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.946|TWO_SIDED|95.0|-19.61|21.01||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 0.07|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||21.01|-19.61|0.946
91552785|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|24.44||||0.094|TWO_SIDED|95.0|-4.25|53.13||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.69|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||53.13|-4.25|0.094
91552786|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|23.74||||0.107|TWO_SIDED|95.0|-5.19|52.67||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||52.67|-5.19|0.107
91552787|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.627|TWO_SIDED|95.0|-14.68|24.3||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||24.30|-14.68|0.627
91552788|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|24.91||||0.072|TWO_SIDED|95.0|-2.2|52.01||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.81|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||52.01|-2.20|0.072
91552789|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|20.1||||0.149|TWO_SIDED|95.0|-7.29|47.49||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||47.49|-7.29|0.149
91767448|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.708|TWO_SIDED|95.0|-2.11|1.44|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.44|-2.11|0.708
91552790|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|-1.38||||0.849|TWO_SIDED|95.0|-15.71|12.95||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = -0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||12.95|-15.71|0.849
91552791|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|15.47||||0.134|TWO_SIDED|95.0|-4.83|35.78||Unadjusted p-value|Mixed Models Analysis|(df, 110) = 1.15|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||35.78|-4.83|0.134
91552792|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|16.86||||0.107|TWO_SIDED|95.0|-3.68|37.39||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||37.39|-3.68|0.107
91552793|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.973|TWO_SIDED|95.0|-13.64|13.17||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = -0.03|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||13.17|-13.64|0.973
91767449|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.495|TWO_SIDED|95.0|-2.34|4.82|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.82|-2.34|0.495
91552794|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|14.49||||0.135|TWO_SIDED|95.0|-4.56|33.54||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.50|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||33.54|-4.56|0.135
91552795|NCT02938923|182991056|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.134|TWO_SIDED|95.0|-4.55|34.0||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.51|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||34.00|-4.55|0.134
91552796|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.125|TWO_SIDED|95.0|-0.34|2.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.55|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.76|-0.34|0.125
91552797|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.758|TWO_SIDED|95.0|-1.9|2.61||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.61|-1.90|0.758
91552798|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.455|TWO_SIDED|95.0|-3.12|1.41||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.75|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.41|-3.12|0.455
91552799|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.229|TWO_SIDED|95.0|-0.72|3.0||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 1.21|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.00|-0.72|0.229
91552800|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.647|TWO_SIDED|95.0|-1.97|3.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.46|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.16|-1.97|0.647
91552801|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.68|TWO_SIDED|95.0|-3.12|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.41|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.04|-3.12|0.680
91552802|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.052|TWO_SIDED|95.0|-0.02|2.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.96|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.97|-0.02|0.052
91552803|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.754|TWO_SIDED|95.0|-1.79|2.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.46|-1.79|0.754
91552804|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.294|TWO_SIDED|95.0|-3.28|1.0||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.06|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.00|-3.28|0.294
91552805|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.031|TWO_SIDED|95.0|0.13|2.78||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.78|0.13|0.031
91552806|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.56|2.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.32|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.16|-1.56|0.752
91552807|NCT02938923|182991057|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.223|TWO_SIDED|95.0|-3.03|0.71||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||0.71|-3.03|0.223
91552808|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.006|TWO_SIDED|95.0|0.24|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.78|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.46|0.24|0.006
91552809|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.863|TWO_SIDED|95.0|-0.81|0.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.17|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.97|-0.81|0.863
91552810|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.091|TWO_SIDED|95.0|-1.67|0.12||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.71|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.12|-1.67|0.091
91552811|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.21|1.44||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.65|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.44|0.21|0.009
91552812|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.778|TWO_SIDED|95.0|-0.76|1.02||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.28|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.02|-0.76|0.778
91552813|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.124|TWO_SIDED|95.0|-1.59|0.19||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.19|-1.59|0.124
91552814|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.027|TWO_SIDED|95.0|0.08|1.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.24|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.31|0.08|0.027
91552815|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.833|TWO_SIDED|95.0|-0.97|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.78|-0.97|0.833
91552816|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.1||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.10|-1.67|0.080
91552817|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.21|0.14|0.014
91552818|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.834|TWO_SIDED|95.0|-0.84|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.68|-0.84|0.834
91552819|NCT02938923|182991058|SUPERIORITY||Mean Difference (Final Values)|-0.75||||0.054|TWO_SIDED|95.0|-1.52|0.01||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.94|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.01|-1.52|0.054
91552820|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.326|TWO_SIDED|95.0|-0.25|0.74||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.99|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.74|-0.25|0.326
91552821|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.587|TWO_SIDED|95.0|-0.87|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.54|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.49|-0.87|0.587
91552822|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.213|TWO_SIDED|95.0|-1.12|0.25||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.25|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.25|-1.12|0.213
91552823|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.41|TWO_SIDED|95.0|-0.32|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.83|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.78|-0.32|0.410
91552824|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.527|TWO_SIDED|95.0|-0.99|0.51||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.63|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.51|-0.99|0.527
91552825|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.219|TWO_SIDED|95.0|-1.23|0.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.23|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.28|-1.23|0.219
91552826|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.25|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.93|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.69|-0.25|0.355
91552827|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.554|TWO_SIDED|95.0|-0.88|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.59|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.47|-0.88|0.554
91552828|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.219|TWO_SIDED|95.0|-1.1|0.26||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.24|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.26|-1.10|0.219
91767450|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.85||||0.243|TWO_SIDED|95.0|-4.96|1.27|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.27|-4.96|0.243
91767451|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.453|TWO_SIDED|95.0|-4.96|2.23|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.23|-4.96|0.453
91552829|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.345|TWO_SIDED|95.0|-0.24|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.95|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.68|-0.24|0.345
91552830|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.494|TWO_SIDED|95.0|-0.88|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.69|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.43|-0.88|0.494
91552831|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.18|TWO_SIDED|95.0|-1.11|0.21||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.35|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.21|-1.11|0.180
91552832|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.4|Difference between the changes of IADL of EX+T - EX+P|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.50|-0.75|0.693
91552833|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.327|TWO_SIDED|95.0|-1.27|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.98|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.43|-1.27|0.327
91552834|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.493|TWO_SIDED|95.0|-1.15|0.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.69|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.56|-1.15|0.493
91767452|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.745|TWO_SIDED|95.0|-2.79|3.89|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.89|-2.79|0.745
91552835|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.698|TWO_SIDED|95.0|-0.72|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.39|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.49|-0.72|0.698
91552836|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.404|TWO_SIDED|95.0|-1.17|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.84|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.47|-1.17|0.404
91552837|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.585|TWO_SIDED|95.0|-1.06|0.6||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.55|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.60|-1.06|0.585
91552838|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.399|TWO_SIDED|95.0|-0.31|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.85|Difference between IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.31|0.399
91552839|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.554|TWO_SIDED|95.0|-0.53|0.98||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.59|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.98|-0.53|0.554
91767453|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.987|TWO_SIDED|95.0|-2.44|2.48|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.48|-2.44|0.987
91552840|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.76|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.76|0.998
91552841|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.378|TWO_SIDED|95.0|-0.28|0.73||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.88|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.73|-0.28|0.378
91767454|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42||||0.218|TWO_SIDED|95.0|-3.69|0.85|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.85|-3.69|0.218
91552842|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.608|TWO_SIDED|95.0|-0.53|0.91||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.51|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.91|-0.53|0.608
91552843|NCT02938923|182991059|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.915|TWO_SIDED|95.0|-0.76|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.11|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.69|-0.76|0.915
91552844|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.602|TWO_SIDED|95.0|-1.36|2.33||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.52|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||2.33|-1.36|0.602
91552845|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.454|TWO_SIDED|95.0|-3.48|1.56||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.75|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.56|-3.48|0.454
91552846|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-1.45||||0.262|TWO_SIDED|95.0|-3.98|1.09||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.13|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.09|-3.98|0.262
91552847|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.639|TWO_SIDED|95.0|-1.47|2.4||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.47|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.40|-1.47|0.639
91767455|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67||||0.63|TWO_SIDED|95.0|-3.41|2.08|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.08|-3.41|0.630
91552848|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.438|TWO_SIDED|95.0|-3.66|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.78|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-3.66|0.438
91552849|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.265|TWO_SIDED|95.0|-4.14|1.14||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.12|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.14|-4.14|0.265
91552850|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.555|TWO_SIDED|95.0|-1.11|2.07||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.07|-1.11|0.555
91552851|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.917|TWO_SIDED|95.0|-2.39|2.15||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.10|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.15|-2.39|0.917
91767456|NCT01787461|183424068|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.576|TWO_SIDED|95.0|-2.06|3.68|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.68|-2.06|0.576
91767457|NCT03259555|183424069|SUPERIORITY||Treatment difference|0.14|||=|0.8797|TWO_SIDED|95.0|-1.74|2.03|||Mixed-effect Model Repeated Measure|"An unstructured covariance was used."|"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||2.03|-1.74|=0.8797
91552852|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.606|TWO_SIDED|95.0|-2.87|1.68||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.52|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||1.68|-2.87|0.606
91552853|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.549|TWO_SIDED|95.0|-1.09|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.60|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.04|-1.09|0.549
91552854|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.887|TWO_SIDED|95.0|-2.38|2.06||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.14|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.06|-2.38|0.887
91552855|NCT02938923|182991060|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.574|TWO_SIDED|95.0|-2.87|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-2.87|0.574
91552856|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.649|TWO_SIDED|95.0|-3.19|5.11||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.46|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||5.11|-3.19|0.649
91552857|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.389|TWO_SIDED|95.0|-3.22|8.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.23|-3.22|0.389
91552858|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|1.55||||0.598|TWO_SIDED|95.0|-4.22|7.31||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.31|-4.22|0.598
91552859|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.676|TWO_SIDED|95.0|-3.26|5.02||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.42|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||5.02|-3.26|0.676
91552860|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|2.48||||0.394|TWO_SIDED|95.0|-3.24|8.19||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.85|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||8.19|-3.24|0.394
91552861|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.585|TWO_SIDED|95.0|-4.15|7.35||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.35|-4.15|0.585
91767458|NCT00607087|183424080|SUPERIORITY_OR_OTHER|||||||0.039||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.039
91552862|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||4.65|-3.56|0.794
91552863|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|2.27||||0.449|TWO_SIDED|95.0|-3.62|8.16||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.76|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.16|-3.62|0.449
91767459|NCT00607087|183424080|SUPERIORITY_OR_OTHER|||||||0.031||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025.|McNemar|||||||0.031
91767460|NCT00607087|183424081|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
91552864|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.567|TWO_SIDED|95.0|-4.2|7.64||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.57|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.64|-4.20|0.567
91552865|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||4.65|-3.56|0.794
91552866|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.526|TWO_SIDED|95.0|-3.97|7.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.64|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.75|-3.97|0.526
91767461|NCT00607087|183424081|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
91552867|NCT02938923|182991061|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.654|TWO_SIDED|95.0|-4.55|7.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.23|-4.55|0.654
91552868|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.597|TWO_SIDED|95.0|-1.72|2.98||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+T - EX+P) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||2.98|-1.72|0.597
91552869|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.184|TWO_SIDED|95.0|-5.41|1.04||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.33|Difference between the changes (EX+T - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||1.04|-5.41|0.184
91767462|NCT00607087|183424082|SUPERIORITY_OR_OTHER|||||||0.08||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.080
91767463|NCT00607087|183424082|SUPERIORITY_OR_OTHER|||||||0.107||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.107
91767464|NCT00607087|183424083|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
91767465|NCT00607087|183424083|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||<0.001
91767466|NCT00607087|183424084|SUPERIORITY_OR_OTHER|||||||0.079||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.079
91767467|NCT00607087|183424084|SUPERIORITY_OR_OTHER|||||||0.063||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.063
91767468|NCT00607087|183424085|SUPERIORITY_OR_OTHER|||||||0.015||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.015
91552870|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.82||||0.089|TWO_SIDED|95.0|-6.07|0.44||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.71|Difference between the changes (EX+P - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||0.44|-6.07|0.089
91552871|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.635|TWO_SIDED|95.0|-2.01|3.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.47|Difference in the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.28|-2.01|0.635
91552872|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.15||||0.242|TWO_SIDED|95.0|-5.76|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.17|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1.46|-5.76|0.242
91552873|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.79||||0.132|TWO_SIDED|95.0|-6.42|0.85||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.51|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||0.85|-6.42|0.132
91767469|NCT00607087|183424085|SUPERIORITY_OR_OTHER|||||||0.073||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.073
91767470|NCT00607087|183424086|SUPERIORITY_OR_OTHER|||||||0.017||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.017
91767471|NCT00607087|183424086|SUPERIORITY_OR_OTHER|||||||0.032||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.032
91767472|NCT00607087|183424087|SUPERIORITY_OR_OTHER|||||||0.009||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.009
91552874|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.193|TWO_SIDED|95.0|-0.77|3.81||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.31|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.81|-0.77|0.193
91552875|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.39|TWO_SIDED|95.0|-1.86|4.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||4.75|-1.86|0.390
91552876|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.965|TWO_SIDED|95.0|-3.39|3.25||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.04|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.25|-3.39|0.965
91552877|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.195|TWO_SIDED|95.0|-0.79|3.82||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.30|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.82|-0.79|0.195
91767473|NCT00607087|183424087|SUPERIORITY_OR_OTHER|||||||0.019||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.019
91552878|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.418|TWO_SIDED|95.0|-1.93|4.63||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.81|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||4.63|-1.93|0.418
91552879|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.921|TWO_SIDED|95.0|-3.46|3.13||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.10|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.13|-3.46|0.921
91552880|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.078|TWO_SIDED|95.0|-0.26|4.88||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.77|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||4.88|-0.26|0.078
91552881|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.982|TWO_SIDED|95.0|-3.51|3.43||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.02|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.43|-3.51|0.982
91552882|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.35||||0.187|TWO_SIDED|95.0|-5.85|1.15||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.32|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||1.15|-5.85|0.187
91552883|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|2.16||||0.08|TWO_SIDED|95.0|-0.26|4.58||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.76|Difference of the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||4.58|-0.26|0.080
91552884|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.781|TWO_SIDED|95.0|-3.76|2.83||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.28|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.83|-3.76|0.781
91552885|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.121|TWO_SIDED|95.0|-5.94|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.56|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.69|-5.94|0.121
91552886|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.148|TWO_SIDED|95.0|-0.57|3.73||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.45|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.73|-0.57|0.148
91552887|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.699|TWO_SIDED|95.0|-3.64|2.45||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.39|Differences between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||2.45|-3.64|0.699
91767474|NCT00607087|183424088|SUPERIORITY_OR_OTHER|||||||0.008||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.008
91552888|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.163|TWO_SIDED|95.0|-5.24|0.89||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.4|Difference in the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||0.89|-5.24|0.163
91552889|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.137|TWO_SIDED|95.0|-0.51|3.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.49|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||3.69|-0.51|0.137
91552890|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.648|TWO_SIDED|95.0|-3.68|2.29||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.46|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.29|-3.68|0.648
91552891|NCT02938923|182991062|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.135|TWO_SIDED|95.0|-5.29|0.72||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.50|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.72|-5.29|0.135
91552892|NCT02938923|182991063|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.821|TWO_SIDED|95.0|-0.073|0.058||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.23|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.058|-0.073|0.821
91552893|NCT02938923|182991063|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.789|TWO_SIDED|95.0|-0.082|0.108||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.27|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.108|-0.082|0.789
91552894|NCT02938923|182991063|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.672|TWO_SIDED|95.0|-0.075|0.116||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.42|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.116|-0.075|0.672
91552895|NCT02938923|182991063|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.703|TWO_SIDED|95.0|-0.013|0.009||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.38||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EX+P)|0.009|-0.013|0.703
91552896|NCT02938923|182991063|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.803|TWO_SIDED|95.0|-0.017|0.014||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.25||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EUC)|0.014|-0.017|0.803
91552897|NCT02938923|182991063|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.015|0.016||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.01||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+P - EUC)|0.016|-0.015|0.991
91767475|NCT00607087|183424088|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
91767476|NCT00607087|183424089|SUPERIORITY_OR_OTHER|||||||0.563||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.563
91552898|NCT03663205|182991064|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.0054|TWO_SIDED|95.0|0.465|0.912|||One-sided, Log Rank Test||Stratified by stratification factors: disease stage (IIIB or IV) and the level of PD-L1 expression in tumor cells (\>=50%, 1% to 49%, \<1%)|||0.912|0.465|0.0054
91552899|NCT03663205|182991071|OTHER||Least squares mean difference|-2.2|||||TWO_SIDED|95.0|-7.4|3.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 coughing score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in coughing score||3.1|-7.4|
91552900|NCT03663205|182991071|OTHER||Least squares mean difference|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 dyspnea score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in dyspnea score||2.1|-4.4|
91552901|NCT03663205|182991071|OTHER||Least squares mean difference|-3.2|||||TWO_SIDED|95.0|-7.6|1.2|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 chest pain score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in chest pain score||1.2|-7.6|
91552902|NCT03663205|182991072|OTHER||Least squares mean difference|3.9|||||TWO_SIDED|95.0|-0.9|8.7|||||Based on a constrained longitudinal data analysis model with QLQ-LC30 Global Health Status/Quality of Life score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in Global Health Status/Quality of Life score||8.7|-0.9|
91767477|NCT00607087|183424089|SUPERIORITY_OR_OTHER|||||||0.186||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.186
91767478|NCT00607087|183424090|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
91552903|NCT02326974|182991075|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|||By estimating that the overall pCR with T-DM1 plus pertuzumab would be approximately 40%, and 20% of the population classified as heterogeneous, the study would have 80% power with 136 evaluable patients to detect a difference in pCR of 44.9% in the non-heterogenous versus 20.3% in the heterogenous subgroup. The study had a 90% power to detect difference in pCR of 43.4% in the non-heterogenous versus 8.8% in the heterogenous subgroup if the observed prevalence of HER2 heterogeneity was 10%.||||<0.001
91552904|NCT04505410|182991170|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91552905|NCT05654662|182991173|SUPERIORITY|||||||0.0032|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||0.0032
91552906|NCT05654662|182991174|SUPERIORITY||Adjusted Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.03||0.0013|TWO_SIDED|95.0|-10.6|-2.6|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test product minus reference product.|||-2.6|-10.6|0.0013
91552907|NCT05654662|182991175|SUPERIORITY|||||||0.0181|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||0.0181
91552908|NCT05654662|182991175|SUPERIORITY|||||||0.0541|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||0.0541
91552909|NCT05654662|182991176|SUPERIORITY||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.44||0.0091|TWO_SIDED|95.0|-6.7|-1.0|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-1.0|-6.7|0.0091
91552910|NCT05654662|182991176|SUPERIORITY||Adjusted Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.78||0.0031|TWO_SIDED|95.0|-8.8|-1.8|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-1.8|-8.8|0.0031
91552911|NCT05654662|182991177|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
91552912|NCT05654662|182991177|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
91552913|NCT05654662|182991177|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
91552914|NCT05654662|182991178|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.011||0.0051|TWO_SIDED|95.0|-0.05|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.01|-0.05|0.0051
91552915|NCT05654662|182991178|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0034|TWO_SIDED|95.0|-0.07|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.01|-0.07|0.0034
91552916|NCT05654662|182991178|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.015||0.0022|TWO_SIDED|95.0|-0.08|-0.02|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.02|-0.08|0.0022
91552917|NCT05654662|182991179|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
91552918|NCT05654662|182991179|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
91552919|NCT05654662|182991179|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
91552920|NCT05654662|182991180|SUPERIORITY||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.12|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.04|-0.12|<0.0001
91552921|NCT05654662|182991180|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.07|-0.18|<0.0001
91552922|NCT05654662|182991180|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.2|-0.08|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.08|-0.20|<0.0001
91552923|NCT05654662|182991181|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
91552924|NCT05654662|182991181|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
91552925|NCT05654662|182991181|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
91552926|NCT05654662|182991182|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.0012|TWO_SIDED|95.0|-0.25|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.25|0.0012
91552927|NCT05654662|182991182|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.0058|TWO_SIDED|95.0|-0.29|-0.05|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.05|-0.29|0.0058
91552928|NCT05654662|182991182|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.42|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.42|<0.0001
91552929|NCT05654662|182991183|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
91552930|NCT05654662|182991183|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
91552931|NCT05654662|182991183|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
91552932|NCT05654662|182991184|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.051||0.0022|TWO_SIDED|95.0|-0.26|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.26|0.0022
91552933|NCT05654662|182991184|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0099|TWO_SIDED|95.0|-0.3|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.04|-0.30|0.0099
91552934|NCT05654662|182991184|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|-0.45|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.45|<0.0001
91552935|NCT05247034|182991216|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
91552936|NCT05247034|182991216|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91552937|NCT05247034|182991216|OTHER|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||||||0.0125
91552938|NCT05247034|182991217|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||For 1 Hz||||>0.05
91552939|NCT05247034|182991217|OTHER||||||>|0.05|||||||t-test, 2 sided|||5 and 10 Hz||||>0.05
91552940|NCT05247034|182991217|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
91552941|NCT05247034|182991217|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
91552942|NCT05247034|182991218|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552943|NCT05247034|182991218|OTHER|||||||0.042|||||||Friedman|||||||0.042
91552944|NCT05247034|182991218|OTHER|||||||0.015|||||||Friedman|||||||0.015
91552945|NCT05247034|182991219|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
91552946|NCT05247034|182991219|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
91552947|NCT05247034|182991219|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
91552948|NCT05247034|182991220|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552949|NCT05247034|182991220|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552950|NCT05247034|182991220|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552951|NCT05247034|182991221|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
91552952|NCT05247034|182991221|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552953|NCT05247034|182991221|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552954|NCT05247034|182991222|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
91552955|NCT05247034|182991222|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552956|NCT05247034|182991222|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552957|NCT05247034|182991223|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
91552958|NCT05247034|182991223|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552959|NCT05247034|182991223|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552960|NCT05247034|182991224|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552961|NCT05247034|182991224|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552962|NCT05247034|182991224|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
91552963|NCT05247034|182991225|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552964|NCT05247034|182991225|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
91552965|NCT05247034|182991225|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
91552966|NCT05247034|182991226|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552967|NCT05247034|182991226|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552968|NCT05247034|182991226|OTHER|||||||0.0027|||||||Wilcoxon (Mann-Whitney)|||||||0.0027
91552969|NCT05247034|182991227|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552970|NCT05247034|182991227|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552971|NCT05247034|182991227|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.0430
91552972|NCT05247034|182991228|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552973|NCT05247034|182991228|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552974|NCT05247034|182991228|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91552975|NCT05247034|182991229|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
91552976|NCT05247034|182991229|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91552977|NCT05247034|182991229|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552978|NCT05247034|182991230|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552979|NCT05247034|182991230|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552980|NCT05247034|182991230|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91552981|NCT05247034|182991231|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552982|NCT05247034|182991231|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552983|NCT05247034|182991231|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91552984|NCT05247034|182991232|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552985|NCT05247034|182991232|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91552986|NCT05247034|182991232|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91552987|NCT05247034|182991233|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
91552988|NCT05247034|182991233|OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||||||0.0007
91767479|NCT00607087|183424090|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
91767480|NCT00607087|183424091|SUPERIORITY_OR_OTHER|||||||1||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||1.000
91552989|NCT05247034|182991233|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91767481|NCT00607087|183424091|SUPERIORITY_OR_OTHER|||||||0.701||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.701
91767482|NCT00607087|183424094|SUPERIORITY_OR_OTHER|||||||0.078||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c value at the start of the first period||||||0.078
91767483|NCT00607087|183424094|SUPERIORITY_OR_OTHER|||||||0.938||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c level at the start of the first period||||||0.938
91767484|NCT02717494|183424099|OTHER||% with grade 3+ AEs, up to week 4 Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
91767485|NCT02717494|183424099|OTHER||% with grade 3+ AEs, up to week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|7.0|||||Confidence intervals were Exact Clopper-Pearson.|||7|1|
91767486|NCT02717494|183424099|OTHER||% with grade 3+ AEs up to week 4, Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
91767487|NCT02717494|183424099|OTHER||% with grade 4+ AEs after week 4, Step 1|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
91767488|NCT02717494|183424099|OTHER||% with grade 4+ AEs after week 4, Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||||Confidence intervals were Exact Clopper-Pearson.|5|0|
91552990|NCT02668692|182991256|SUPERIORITY||Odds Ratio (OR)|1.96|||=|0.68|TWO_SIDED|95.0|0.35|10.95|||Fisher Exact|||Statistical analysis of the FAS.||10.95|0.35|=0.68
91767489|NCT02717494|183424099|OTHER||% with grade 4+ AEs, after week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
91767490|NCT02717494|183424099|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
91552991|NCT02668692|182991256|SUPERIORITY||Odds Ratio (OR)|1.92|||=|0.68|TWO_SIDED|95.0|0.34|10.72||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||10.72|0.34|=0.68
91552992|NCT02668692|182991257|SUPERIORITY||Odds Ratio (OR)|0.28|||=|0.009|TWO_SIDED|95.0|0.11|0.74|||Fisher Exact|||Statistical analysis for the FAS.||0.74|0.11|=0.009
91552993|NCT02668692|182991257|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.003|TWO_SIDED|95.0|0.08|0.63||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||0.63|0.08|=0.003
91767491|NCT02717494|183424099|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
91767492|NCT02717494|183424099|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
91767493|NCT02717494|183424100|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
91767494|NCT02717494|183424100|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
91767495|NCT02717494|183424101|OTHER||% infants with grade 3+ AEs|21.0|||||TWO_SIDED|90.0|14.0|28.0|||||Confidence intervals were Exact Clopper-Pearson.|||28|14|
91767496|NCT02717494|183424101|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||||Confidence intervals were Exact Clopper-Pearson.|27|14|
91767497|NCT02717494|183424101|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||Confidence intervals were Exact Clopper-Pearson.|||27|14|
91767498|NCT02717494|183424101|OTHER||% infants with congenital anomalies|17.0|||||TWO_SIDED|90.0|11.0|24.0|||||||Confidence intervals were Exact Clopper-Pearson.|24|11|
91767499|NCT02717494|183424101|OTHER||% infants with congenital anomalies|22.0|||||TWO_SIDED|90.0|15.0|29.0|||||||Confidence intervals were Exact Clopper-Pearson.|29|15|
91767500|NCT02717494|183424101|OTHER||% infants with congenital anomalies|13.0|||||TWO_SIDED|90.0|8.0|19.0|||||Confidence intervals were Exact Clopper-Pearson.|||19|8|
91767501|NCT02717494|183424101|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||||Confidence intervals were Exact Clopper-Pearson.|3|0|
91767502|NCT02717494|183424101|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||Confidence intervals were Exact Clopper-Pearson.|||3|0|
91767503|NCT02717494|183424101|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Confidence intervals were Exact Clopper-Pearson.|||2|0|
91767504|NCT02717494|183424101|OTHER||% with pneumonia, meningitis or IPD|4.0|||||TWO_SIDED|90.0|2.0|9.0|||||Confidence intervals were Exact Clopper-Pearson.|||9|2|
91767505|NCT02717494|183424101|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
91767506|NCT02717494|183424101|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
91767507|NCT02717494|183424102|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at day 28.||||||0.44||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.44
91767508|NCT02717494|183424102|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with values \>=0.35ug/mL at day 28.||||||0.49||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.49
91552994|NCT03442309|182991269|NON_INFERIORITY|NI margin for arrest difference of 10%|Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.22|0.01||||||||0.01|-.22|
91552995|NCT03442309|182991270|NON_INFERIORITY|Non-inferiority OR (OR δ, 0.63)|Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||||1.08|0.82|
91552996|NCT04615273|182991287|SUPERIORITY||Estimate of Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-2.94|-1.14|||ANCOVA|||Analysis included treatment arm, region, baseline age group, gender, concomitant oral estrogen, Adult Growth Hormone Deficiency (AGHD) onset as factors \& baseline trunk percent fat as the covariates. Multiple imputation method was used to impute missing data.||-1.14|-2.94|<.0001
91552997|NCT04200313|182991420|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91552998|NCT04200313|182991420|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91552999|NCT04200313|182991421|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553000|NCT04200313|182991421|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553001|NCT04200313|182991422|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553002|NCT04200313|182991422|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553003|NCT04200313|182991423|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553004|NCT04200313|182991423|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553005|NCT04200313|182991424|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553006|NCT04200313|182991424|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91767509|NCT02717494|183424102|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.|||99|91|
91553007|NCT04200313|182991425|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553008|NCT04200313|182991425|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553009|NCT04200313|182991426|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553010|NCT04200313|182991426|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91553011|NCT04200313|182991427|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
91553012|NCT04200313|182991427|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
91553013|NCT03314740|182991509|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.265|TWO_SIDED|90.0|0.5|1.14|||cox model|||||1.14|0.5|0.265
91553014|NCT03314740|182991509|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.904|TWO_SIDED|90.0|0.68|1.55|||cox- model|||||1.55|0.68|0.904
91553015|NCT00971087|182991556|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|3D + s2D will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. That is, our null hypothesis is that the AUC for 3D + s2D is 0.05 less than the AUC for 2D FFDM. A difference of 0.05 is considered a clinically significant difference.||||||0.009|||||||MRMC ROC Analysis|||A multi-reader, multi-case ROC analysis will be used to compare 3D + s2D to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance.||||0.009
91553016|NCT00971087|182991557|NON_INFERIORITY|A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit onesided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05.||||||0.045|||||||MRMC ROC Analysis|||||||0.045
91553017|NCT01447719|182991567|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|92.0|||||TWO_SIDED|95.0|78.0|98.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a positive scan based on majority of 5 blinded readers||98|78|
91553018|NCT01447719|182991568|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|80.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|80|
91553019|NCT01447719|182991569|SUPERIORITY_OR_OTHER_LEGACY||Correlation coefficient|0.76|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|0.62|0.85||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|Asymptotic standard error and 95 percent CI used Fisher z-transformation.||Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.85|0.62|<0.0001
91553020|NCT01447719|182991570|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|96.0|||||TWO_SIDED|95.0|80.0|100.0||||||Proportion of subjects who had a positive scan based on majority of 5 blinded readers||100|80|
91553021|NCT01447719|182991571|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|78.0|100.0||||||Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|78|
91553022|NCT05932407|182991579|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|2.0||||||Crude hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Crude hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||2.0|0.1|
91553023|NCT05932407|182991579|SUPERIORITY|Adjusted hazard ratio was adjusted from crude hazard ratio by covariance 1 (age and gender), and covariance 2 (antithrombotic drug administration, NSAID administration, and hypertension).|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|1.9||||||Adjusted hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Adjusted hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||1.9|0.1|
91553024|NCT03812614|182991591|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.07|TWO_SIDED|95.0|-0.05|1.14|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in HbA1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language.||1.14|-0.05|0.07
91767510|NCT02717494|183424102|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|94|
91767511|NCT02717494|183424102|OTHER||% with >=2 fold increase|6.0|||||TWO_SIDED|95.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
91767512|NCT02717494|183424102|OTHER||% vaccinees with >=0.35ug/mL at day 28|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
91553025|NCT03812614|182991592|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.67|0.64|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in A1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language||0.64|-0.67|0.96
91553026|NCT03812614|182991593|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.55|TWO_SIDED|95.0|-6.4|3.38|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||3.38|-6.40|0.55
91553027|NCT03812614|182991594|SUPERIORITY||Mean Difference (Final Values)|5.74||||0.03|TWO_SIDED|95.0|0.57|10.91|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||10.91|0.57|0.03
91553028|NCT03812614|182991595|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.76|TWO_SIDED|95.0|-2.15|1.58|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.58|-2.15|0.76
91553029|NCT03812614|182991596|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.72|TWO_SIDED|95.0|-2.11|1.46|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.46|-2.11|0.72
91553030|NCT03812614|182991597|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.38|TWO_SIDED|95.0|-0.76|0.29|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient health eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.29|-0.76|0.38
91553031|NCT03812614|182991598|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.11|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient physical activity was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-1.11|0.70
91553032|NCT03812614|182991599|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.75|TWO_SIDED|95.0|-0.53|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-0.53|0.75
91553033|NCT03812614|182991599|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.94|TWO_SIDED|95.0|-0.98|0.91|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.91|-0.98|0.94
91553034|NCT03812614|182991599|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.42|TWO_SIDED|95.0|-1.46|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.46|0.42
91553035|NCT03812614|182991600|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.54|0.52|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient self-efficacy was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.52|-0.54|0.96
91553036|NCT03812614|182991601|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.4|TWO_SIDED|95.0|-3.92|9.78|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||9.78|-3.92|0.40
91553037|NCT03812614|182991602|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.18|1.68|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.68|-0.18|0.11
91553038|NCT03812614|182991603|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.34|TWO_SIDED|95.0|-0.19|0.55|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.55|-0.19|0.34
91553039|NCT03812614|182991605|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.47|TWO_SIDED|95.0|-2.67|1.23|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.23|-2.67|0.47
91553040|NCT03812614|182991606|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.35|TWO_SIDED|95.0|-0.78|0.27|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||0.27|-0.78|0.35
91553041|NCT03812614|182991607|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient healthy eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.01|-1.00|0.06
91553042|NCT03812614|182991608|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.45|TWO_SIDED|95.0|-1.22|0.54|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.54|-1.22|0.45
91553043|NCT03812614|182991609|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4|TWO_SIDED|95.0|-0.86|0.35|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.35|-0.86|0.40
91553044|NCT03812614|182991609|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.9|0.88|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.88|-0.90|0.98
91553045|NCT03812614|182991609|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.43|TWO_SIDED|95.0|-1.42|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.42|0.43
91553046|NCT03812614|182991610|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.01|-1.00|0.06
91553047|NCT03812614|182991611|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.92|TWO_SIDED|95.0|-7.22|6.49|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||6.49|-7.22|0.92
91553048|NCT03812614|182991612|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.02|TWO_SIDED|95.0|0.21|1.99|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.99|0.21|0.02
91553049|NCT03812614|182991613|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.06|TWO_SIDED|95.0|-0.01|0.7|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.70|-0.01|0.06
91553050|NCT03812614|182991614|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.49|TWO_SIDED|95.0|-2.19|4.57|||Mixed Models Analysis|||Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.|Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|4.57|-2.19|0.49
91553051|NCT03812614|182991615|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.08|TWO_SIDED|95.0|-0.09|1.66|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.66|-0.09|0.08
91553052|NCT02518048|182991638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.17|||<|0.001|TWO_SIDED|95.0|-2.58|-1.76||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).|ANOVA|||A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values.||-1.76|-2.58|<0.001
91553053|NCT02518048|182991641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.53|-0.32||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Total Skin Thickness: LEO 90100 vs. Betesil®||-0.32|-0.53|<0.001
91553054|NCT02518048|182991641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.41||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Echo-Poor Band Thickness: LEO 90100 vs. Betesil®||-0.41|-0.69|<0.001
91553055|NCT05123027|182991652|SUPERIORITY||Risk Ratio (RR)|0.7||||0.399|TWO_SIDED|95.0|0.3|1.62||Threshold for significance: p\< 0.05|Mixed Models Analysis|||The primary outcome was analyzed with a longitudinal mixed effects negative binomial model incorporating the total score at earlier time points as well as 180 days. Fixed effect covariates included baseline score, treatment, days, site, stratum, and an interaction between treatment and days. A random effect was included to account for correlation within each participant.||1.62|0.30|0.399
91553056|NCT05123027|182991653|SUPERIORITY||Risk Ratio (RR)|1.09||||0.53|TWO_SIDED|95.0|0.83|1.45||Threshold for significance: p\< 0.05|Mixed Models Analysis|||This was modeled similar to the primary outcome, an over dispersed Poisson regression model with fixed effect covariates for treatment arm, treatment days, site, and stratum with an interaction between treatment arm and treatment days. Note that no baseline score covariate was included as all participants will be considered to have achieved 0 steps at baseline. A random intercept was included for each subject to account for repeated measures.||1.45|0.83|0.53
91553057|NCT05879991|182991663|OTHER||Ratio of adjusted geometric means [%]|76.18|||||TWO_SIDED|90.0|70.21|82.65|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|"Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale.~The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale."||82.65|70.21|
91767513|NCT02717494|183424102|OTHER||% vaccinees with >=0.35ug/mL at day 28|100.0|||||TWO_SIDED|95.0|97.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|97|
91553058|NCT05879991|182991668|OTHER||Ratio of adjusted geometric means [%]|26.1|||||TWO_SIDED|90.0|22.12|30.79|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 16.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||30.79|22.12|
91553059|NCT05879991|182991669|OTHER||Ratio of adjusted geometric means [%]|76.99|||||TWO_SIDED|90.0|70.92|83.59|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||83.59|70.92|
91553060|NCT05464069|182991670|SUPERIORITY|||||||0.16||||||Significant level \< 0.05|t-test, 2 sided|||||||0.160
91553061|NCT05465239|182991678|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for control subjects.|||||<|0.001|||||||t-test, 1 sided|||||||< 0.001
91553062|NCT05465239|182991678|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for subjects with walking disabilities.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91553063|NCT02905331|182991684|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91553064|NCT02905331|182991685|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91553065|NCT02905331|182991690|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91553066|NCT03969563|182991716|EQUIVALENCE|Equivalence based on non-significant difference between MBSR and Brain Health groups.|Mean Difference (Final Values)|0.3||||0.694|TWO_SIDED||||||Mixed Models Analysis|||||||.694
91553067|NCT03969563|182991717|EQUIVALENCE|Equivalence based on non-significant difference between MBSR vs Brain Health group.|Mean Difference (Final Values)|-1.4||||0.837|TWO_SIDED||||||Mixed Models Analysis|||||||.837
91553068|NCT04424316|182991733|OTHER||Vaccine Efficacy|57.6|||||TWO_SIDED|95.0|31.3|74.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|31.3|
91553069|NCT04424316|182991734|OTHER||Vaccine Efficacy|54.5|||||TWO_SIDED|95.0|33.2|69.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||69.5|33.2|
91553070|NCT04424316|182991735|OTHER||Vaccine Efficacy|50.0|||||TWO_SIDED|95.0|30.3|64.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||64.5|30.3|
91553071|NCT04424316|182991736|OTHER||Vaccine Efficacy|49.2|||||TWO_SIDED|95.0|31.4|62.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||62.8|31.4|
91553072|NCT04424316|182991737|OTHER||Vaccine Efficacy|82.4|||||TWO_SIDED|95.0|57.5|93.9||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||93.9|57.5|
91553073|NCT04424316|182991738|OTHER||Vaccine Efficacy|73.5|||||TWO_SIDED|95.0|50.3|86.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.8|50.3|
91553074|NCT04424316|182991739|OTHER||Vaccine Efficacy|70.5|||||TWO_SIDED|95.0|49.4|83.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||83.6|49.4|
91553075|NCT04424316|182991740|OTHER||Vaccine Efficacy|70.0|||||TWO_SIDED|95.0|50.6|82.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||82.5|50.6|
91553076|NCT04424316|182991756|OTHER||Vaccine efficacy|69.7|||||TWO_SIDED|95.0|37.1|86.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.7|37.1|
91553077|NCT04424316|182991756|OTHER||Vaccine efficacy|61.5|||||TWO_SIDED|95.0|28.6|80.3||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||80.3|28.6|
91553078|NCT04424316|182991756|OTHER||Vaccine efficacy|57.1|||||TWO_SIDED|95.0|23.9|76.8||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||76.8|23.9|
91553079|NCT04424316|182991756|OTHER||Vaccine efficacy|55.3|||||TWO_SIDED|95.0|23.8|74.6||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|23.8|
91553080|NCT04424316|182991756|OTHER||Vaccine efficacy|24.2|||||TWO_SIDED|95.0|-11.1|48.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||48.6|-11.1|
91553081|NCT04424316|182991757|OTHER||Vaccine efficacy|9.5|||||TWO_SIDED|95.0|-10.1|25.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||25.7|-10.1|
91767514|NCT02717494|183424102|OTHER||% with >=0.35ug/mL at day 28|94.0|||||TWO_SIDED|95.0|88.0|97.0|||||Confidence intervals were Exact Clopper-Pearson.|||97|88|
91767515|NCT02717494|183424103|SUPERIORITY|||||||0.29||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.29
91767516|NCT02717494|183424104|SUPERIORITY|||||||0.08||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.08
91553082|NCT04424316|182991757|OTHER||Vaccine efficacy|6.7|||||TWO_SIDED|95.0|-9.8|20.7||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.7|-9.8|
91553083|NCT04424316|182991757|OTHER||Vaccine efficacy|7.7|||||TWO_SIDED|95.0|-6.5|20.1||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.1|-6.5|
91553084|NCT04424316|182991757|OTHER||Vaccine efficacy|4.1|||||TWO_SIDED|95.0|-9.5|16.0||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||16.0|-9.5|
91553085|NCT04424316|182991757|OTHER||Vaccine efficacy|4.6|||||TWO_SIDED|95.0|-6.6|14.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||14.6|-6.6|
91553086|NCT04424316|182991758|OTHER||Vaccine efficacy|43.8|||||TWO_SIDED|95.0|25.6|57.7||||||Vaccine efficacy at 210 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||57.7|25.6|
91553087|NCT04424316|182991758|OTHER||Vaccine efficacy|39.7|||||TWO_SIDED|95.0|21.3|54.1||||||Vaccine efficacy at 240 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||54.1|21.3|
91553088|NCT04424316|182991758|OTHER||Vaccine efficacy|35.0|||||TWO_SIDED|95.0|16.1|49.9||||||Vaccine efficacy at 270 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||49.9|16.1|
91553089|NCT04424316|182991758|OTHER||Vaccine efficacy|33.0|||||TWO_SIDED|95.0|15.2|47.1||||||Vaccine efficacy at 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||47.1|15.2|
91553090|NCT01116895|182991781|OTHER||Least square mean difference|-2.2||||0.89|TWO_SIDED|95.0|-32.6|28.2|||ANOVA|||||28.2|-32.6|0.89
91553091|NCT01116895|182991781|OTHER||Least square mean difference|4.5||||0.77|TWO_SIDED|95.0|-26.2|35.3|||ANOVA|||||35.3|-26.2|0.77
91553092|NCT01116895|182991781|OTHER||Least square mean difference|-6.7||||0.65|TWO_SIDED|95.0|-36.2|22.8|||ANOVA|||||22.8|-36.2|0.65
91767517|NCT02717494|183424105|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at labor and delivery.||||||0.37||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.37
91553093|NCT03995979|182991786|SUPERIORITY|||||||0.05||||||The P-value was calculated using a paired t test|Paired t-test|||A compositional analysis with species-level alpha diversity will be performed between the three conditions (Pre-Dietary Restriction, Dietary Restriction, and Post-Dietary Restriction,) with ANOVA testing. Furthermore, a differential abundance analysis will be performed to further identify and confirm prevalent organisms associated with the experimental dietary restriction.||||0.05
91553094|NCT05652010|182991787|OTHER|Comparative study|Odds Ratio (OR)|0.576||||0.164|TWO_SIDED|95.0|0.2634|1.2659||P=0.164 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model. As it was an exploratory study no adjustment for multiple comparison was performed.|P=0.164 for testing the hypothesis that OR=1|||1.2659|0.2634|0.164
91553095|NCT05652010|182991788|OTHER||Binominal|0.9|||<|0.0001|TWO_SIDED|95.0|0.75|0.97|||Exact test in the binomial distribution|Exact test in the binomial distribution tested if the proportion of very satisfied/satisfied was sign. different from 50% when using a 5% test level|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|||0.97|0.75|<0.0001
91553096|NCT05652010|182991789|OTHER|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|Binominal|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.92|||Exact test in the binominal distribution|Exact test in the binomial distribution tested if the proportion of YES was significantly different from 50% when using a 5% test level||||0.92|0.66|<0.0001
91553097|NCT05652010|182991790|OTHER||Odds Ratio (OR)|0.259||||0.027|TWO_SIDED|95.0|0.078|0.855||P=0.027 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model|P=0.027 for testing the hypothesis that OR=1|||0.855|0.078|0.027
91553098|NCT04763772|182991791|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.2|TWO_SIDED|95.0|-14.0|4.8|||Regression, Linear|||||4.8|-14|0.2
91767518|NCT02717494|183424105|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at 24 weeks post partum.||||||0.21|||||||Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.21
91767519|NCT02717494|183424106|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0||The threshold for statistical significance is 0.05.|||Confidence intervals were Exact Clopper-Pearson.|||99|91|
91767520|NCT02717494|183424106|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|89.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|89|
91767521|NCT02717494|183424107|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||||Confidence intervals were Exact Clopper-Pearson.|100|94|
91767522|NCT02717494|183424107|OTHER||% vaccinees with >=2fold increase|100.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
91553099|NCT04564209|182991859|SUPERIORITY|||||||0.455|||||||ANOVA|||||||.455
91553100|NCT04564209|182991860|SUPERIORITY|||||||0.415|||||||ANOVA|||||||.415
91553101|NCT04564209|182991861|SUPERIORITY|||||||0.443|||||||ANOVA|||||||.443
91553102|NCT04564209|182991862|SUPERIORITY|||||||0.457|||||||ANOVA|||||||.457
91553103|NCT04564209|182991863|SUPERIORITY|||||||0.099|||||||ANOVA|||||||.099
91553104|NCT04564209|182991864|SUPERIORITY|||||||0.338|||||||ANOVA|||||||.338
91553105|NCT04564209|182991865|SUPERIORITY|||||||0.723|||||||ANOVA|||||||.723
91553106|NCT04564209|182991867|SUPERIORITY|||||||0.578|||||||t-test, 2 sided|||||||.578
91553107|NCT04564209|182991868|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||.998
91553108|NCT04564209|182991869|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||||||.864
91553109|NCT04099732|182991871|OTHER||Ratio of geometric means (T/R) %|183.36|||||TWO_SIDED|90.0|164.35|204.56|||||Geometric coefficient of variation (gCV) = 16.5.|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.56|164.35|
91553110|NCT04099732|182991872|OTHER||Ratio of geometric means (T/R) %|174.01|||||TWO_SIDED|90.0|154.73|195.68|||||Geometric coefficient of variation (gCV) = 17.7|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||195.68|154.73|
91553111|NCT04099732|182991873|OTHER||Ratio of geometric means (T/R) %|119.1|||||TWO_SIDED|90.0|109.84|129.15|||||Geometric coefficient of variation (gCV) = 11.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||129.15|109.84|
91553112|NCT04099732|182991874|OTHER||Ratio of geometric means (T/R) %|119.2|||||TWO_SIDED|90.0|107.68|131.94|||||Geometric coefficient of variation (gCV) = 13.9.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||131.94|107.68|
91553113|NCT04099732|182991875|OTHER||Ratio of geometric means (T/R) %|186.38|||||TWO_SIDED|90.0|169.7|204.71|||||Geometric coefficient of variation (gCV) = 14.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.71|169.70|
91553114|NCT04099732|182991876|OTHER||Ratio of geometric means (T/R) %|120.11|||||TWO_SIDED|90.0|110.78|130.23|||||Geometric coefficient of variation (gCV) = 11.1|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||130.23|110.78|
91553115|NCT03735979|182991877|SUPERIORITY||Posterior Mean Difference (Final Values)|-1.51|STANDARD_DEVIATION|0.51||0.002|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that argatroban was better than placebo was 0.002."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.002
91553116|NCT03735979|182991877|SUPERIORITY||Posterior Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.29||0.04|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that eptifibitide was better than placebo was 0.04."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.04
91553117|NCT02994927|182991925|NON_INFERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||<|0.0001|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|< 0.0001
91553118|NCT02994927|182991925|SUPERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||=|0.2387|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|= 0.2387
91553119|NCT02994927|182991926|NON_INFERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||<|0.0001|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|< 0.0001
91553120|NCT02994927|182991926|SUPERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||=|0.0066|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|= 0.0066
91767523|NCT02717494|183424108|OTHER||% infants with >=0.35ug/mL at week 16|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
91767524|NCT02717494|183424108|OTHER||% infants with >=0.35ug/mL at week 16|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
91767525|NCT02717494|183424108|OTHER||% infants with >=0.35ug/mL at week 16|97.0|||||TWO_SIDED|95.0|91.0|99.0|||||||Confidence intervals were Exact Clopper-Pearson.|99|91|
91767526|NCT02717494|183424108|OTHER||% infants with >=0.35ug/mL at week 24|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
91553121|NCT03533257|182991955|SUPERIORITY|||||||0.3654|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3654
91553122|NCT03533257|182991956|SUPERIORITY|||||||0.6698|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.6698
91553123|NCT03533257|182991957|SUPERIORITY|||||||0.3086|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3086
91553124|NCT03533257|182991958|SUPERIORITY|||||||0.5552|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.5552
91553125|NCT03533257|182991959|SUPERIORITY|||||||0.0361|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.0361
91767527|NCT02717494|183424108|OTHER||% infants with >=0.35ug/mL at week 24|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
91553126|NCT03533257|182991960|SUPERIORITY|||||||0.3585|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3585
91553127|NCT03533257|182991961|SUPERIORITY|||||||0.8996|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.8996
91553128|NCT05525104|182991975|SUPERIORITY|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||||||0.041
91553129|NCT05525104|182991976|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
91767528|NCT02717494|183424108|OTHER||% infants with >=0.35ug/mL at week 24|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
91767529|NCT01774799|183424115|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.69|1.69||||||||1.69|0.69|
91767530|NCT01774799|183424116|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.66|2.2||||||||2.20|0.66|
91553130|NCT05525104|182991980|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
91553131|NCT06149338|182991985|SUPERIORITY|||||||0.0002||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0002
91553132|NCT06149338|182991985|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91553133|NCT06149338|182991986|SUPERIORITY||||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||< 0.0001
91553134|NCT06149338|182991987|SUPERIORITY|||||||0.0041||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0041
91553135|NCT06149338|182991987|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91553136|NCT06149338|182991988|SUPERIORITY|||||||0.7895||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||0.7895
91553137|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|0.09|STANDARD_ERROR_OF_MEAN|0.127||0.4641|TWO_SIDED|90.0|-0.12|0.3|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.30|-0.12|0.4641
91553138|NCT02865538|182992039|OTHER|Descriptive Analysis|Linear mixed-effects model|0.0|STANDARD_ERROR_OF_MEAN|0.128||0.9894|TWO_SIDED|90.0|-0.21|0.21|||LS means difference||Change from Week -1 to Week 1|||0.21|-0.21|0.9894
91553139|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|-0.31|STANDARD_ERROR_OF_MEAN|0.129||0.0199|TWO_SIDED|90.0|-0.52|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-0.52|0.0199
91553140|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|-0.12|STANDARD_ERROR_OF_MEAN|0.133||0.3907|TWO_SIDED|90.0|-0.34|0.11|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.11|-0.34|0.3907
91553141|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.166||0.5393|TWO_SIDED|90.0|-0.17|0.38|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.38|-0.17|0.5393
91553142|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|-0.04|STANDARD_ERROR_OF_MEAN|0.169||0.7931|TWO_SIDED|90.0|-0.33|0.24|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.24|-0.33|0.7931
91553143|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|-0.63|STANDARD_ERROR_OF_MEAN|0.169||0.0004|TWO_SIDED|90.0|-0.92|-0.35|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.35|-0.92|0.0004
91553144|NCT02865538|182992039|OTHER|Descriptive Analysis|LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.175||0.3739|TWO_SIDED|90.0|-0.45|0.13|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.13|-0.45|0.3739
91553145|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|5.29|STANDARD_ERROR_OF_MEAN|3.077||0.09|TWO_SIDED|90.0|0.16|10.42|||Linear mixed-effects model||Change from Week -1 to Week 1|||10.42|0.16|0.0900
91553146|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|-4.46|STANDARD_ERROR_OF_MEAN|3.053||0.1487|TWO_SIDED|90.0|-9.55|0.63|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.63|-9.55|0.1487
91553147|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|-10.18|STANDARD_ERROR_OF_MEAN|3.015||0.0012|TWO_SIDED|90.0|-15.2|-5.15|||Linear mixed-effects model||Change from Week -1 to Week 1|||-5.15|-15.20|0.0012
91767531|NCT01774799|183424117|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.58|1.58||||||||1.58|0.58|
91767532|NCT01774799|183424118|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.13|2.82||||||||2.82|1.13|
91767533|NCT01774799|183424119|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
91767534|NCT05051579|183424135|SUPERIORITY||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-8.9|-4.2|||Mixed Models Analysis|||||-4.2|-8.9|<0.001
91767535|NCT05051579|183424135|SUPERIORITY||LS Mean difference (Final Values)|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
91767536|NCT05051579|183424135|SUPERIORITY||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.4|-8.0|||Mixed Models Analysis|||||-8.0|-12.4|<0.001
91767537|NCT05051579|183424135|SUPERIORITY||LS Mean difference (Final Values)|-10.6|||<|0.001|TWO_SIDED|95.0|-12.7|-8.4|||Mixed Models Analysis|||||-8.4|-12.7|<0.001
91767538|NCT05051579|183424136|OTHER||LS Mean difference (Final Values)|-7.1|||<|0.001|TWO_SIDED|95.0|-9.9|-4.2|||Mixed Models Analysis|||||-4.2|-9.9|<0.001
91767539|NCT05051579|183424136|OTHER||LS Mean difference (Final Values)|-10.1|||<|0.001|TWO_SIDED|95.0|-12.9|-7.3|||Mixed Models Analysis|||||-7.3|-12.9|<0.001
91553148|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|-6.14|STANDARD_ERROR_OF_MEAN|3.142||0.0548|TWO_SIDED|90.0|-11.37|-0.9|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.90|-11.37|0.0548
91553149|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|6.59|STANDARD_ERROR_OF_MEAN|3.337||0.0522|TWO_SIDED|90.0|1.03|12.15|||Linear mixed-effects model||Change from Week -1 to Week 2|||12.15|1.03|0.0522
91553150|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|-5.07|STANDARD_ERROR_OF_MEAN|3.329||0.1326|TWO_SIDED|90.0|-10.61|0.48|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.48|-10.61|0.1326
91553151|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|-12.28|STANDARD_ERROR_OF_MEAN|3.27||0.0004|TWO_SIDED|90.0|-17.73|-6.83|||Linear mixed-effects model||Change from Week -1 to Week 2|||-6.83|-17.73|0.0004
91553152|NCT02865538|182992040|OTHER|Descriptive Analysis|LS means difference|-7.79|STANDARD_ERROR_OF_MEAN|3.408||0.0253|TWO_SIDED|90.0|-13.47|-2.11|||Linear mixed-effects model||Change from Week -1 to Week 2|||-2.11|-13.47|0.0253
91553153|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.3796|TWO_SIDED|90.0|-1.2|4.0|||Linear mixed-effects model||Day 7 Change from Day -1|||4.0|-1.2|0.3796
91553154|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|-2.3|STANDARD_ERROR_OF_MEAN|1.55||0.1413|TWO_SIDED|90.0|-4.9|0.3|||Linear mixed-effects model||Day 7 Change from Day -1|||0.3|-4.9|0.1413
91553155|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|1.55||0.0007|TWO_SIDED|90.0|-8.1|-2.9|||Linear mixed-effects model||Day 7 Change from Day -1|||-2.9|-8.1|0.0007
91553156|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.62||0.0624|TWO_SIDED|90.0|-5.8|-0.4|||Linear mixed-effects model||Day 7 Change from Day -1|||-0.4|-5.8|0.0624
91553157|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|1.3|STANDARD_ERROR_OF_MEAN|1.21||0.293|TWO_SIDED|90.0|-0.7|3.3|||Linear mixed-effects model||Day 14 Change from Day -1|||3.3|-0.7|0.2930
91553158|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.21||0.0512|TWO_SIDED|90.0|-4.4|-0.4|||Linear mixed-effects model||Day 14 Change from Day -1|||-0.4|-4.4|0.0512
91553159|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-7.0|-3.0|||Linear mixed-effects model||Day 14 Change from Day -1|||-3.0|-7.0|<0.0001
91553160|NCT02865538|182992041|OTHER|Descriptive Analysis|LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.25||0.008|TWO_SIDED|90.0|-5.5|-1.3|||Linear mixed-effects model||Day 14 Change from Day -1|||-1.3|-5.5|0.0080
91553161|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|0.84|STANDARD_ERROR_OF_MEAN|0.574||0.1482|TWO_SIDED|90.0|-0.12|1.8|||Linear mixed-effects model||Change from Week -1 to Week 1|||1.80|-0.12|0.1482
91553162|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|-1.04|STANDARD_ERROR_OF_MEAN|0.571||0.0734|TWO_SIDED|90.0|-1.99|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-1.99|0.0734
91553163|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.565||0.0022|TWO_SIDED|90.0|-2.74|-0.86|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.86|-2.74|0.0022
91553164|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.589||0.066|TWO_SIDED|90.0|-2.08|-0.12|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.12|-2.08|0.0660
91553165|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|1.18|STANDARD_ERROR_OF_MEAN|0.613||0.0593|TWO_SIDED|90.0|0.15|2.2|||Linear mixed-effects model||||Change from Week -1 to Week 2|2.20|0.15|0.0593
91553166|NCT02865538|182992042|OTHER||LS means difference|-0.93|STANDARD_ERROR_OF_MEAN|0.614||0.1354|TWO_SIDED|90.0|-1.95|0.1|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.10|-1.95|0.1354
91553167|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.603||0.0005|TWO_SIDED|90.0|-3.21|-1.2|||Linear mixed-effects model||Change from Week -1 to Week 2|||-1.20|-3.21|0.0005
91553168|NCT02865538|182992042|OTHER|Descriptive Analysis|LS means difference|-1.38|STANDARD_ERROR_OF_MEAN|0.628||0.0309|TWO_SIDED|90.0|-2.43|-0.34|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.34|-2.43|0.0309
91553169|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-9.7|STANDARD_ERROR_OF_MEAN|10.88||0.3768|TWO_SIDED|90.0|-27.8|8.5|||Linear mixed-effects model||Change from Day -1 to Day 1|||8.5|-27.8|0.3768
91553170|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-25.0|STANDARD_ERROR_OF_MEAN|10.89||0.0248|TWO_SIDED|90.0|-43.1|-6.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-6.8|-43.1|0.0248
91553171|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-43.9|STANDARD_ERROR_OF_MEAN|10.9||0.0001|TWO_SIDED|90.0|-62.1|-25.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-25.8|-62.1|0.0001
91553172|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-42.9|STANDARD_ERROR_OF_MEAN|11.43||0.0004|TWO_SIDED|90.0|-61.9|-23.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-23.8|-61.9|0.0004
91553173|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|10.4|STANDARD_ERROR_OF_MEAN|14.76||0.4819|TWO_SIDED|90.0|-14.2|35.1|||Linear mixed-effects model||Change from Day -1 to Day 7|||35.1|-14.2|0.4819
91553174|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|14.77||0.8694|TWO_SIDED|90.0|-27.1|22.2|||Linear mixed-effects model||Change from Day -1 to Day 7|||22.2|-27.1|0.8694
91767540|NCT05051579|183424136|OTHER||LS Mean difference (Final Values)|-11.1|||<|0.001|TWO_SIDED|95.0|-13.8|-8.4|||Mixed Models Analysis|||||-8.4|-13.8|<0.001
91767541|NCT05051579|183424136|OTHER||LS Mean difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-15.0|-9.6|||Mixed Models Analysis|||||-9.6|-15.0|<0.001
91767542|NCT05051579|183424137|OTHER||LS Mean difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.3|-4.4|||Mixed Models Analysis|||||-4.4|-9.3|<0.001
91767543|NCT05051579|183424137|OTHER||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.5|-7.8|||Mixed Models Analysis|||||-7.8|-12.5|<0.001
91767544|NCT05051579|183424137|OTHER||LS Mean difference (Final Values)|-10.8|||<|0.001|TWO_SIDED|95.0|-13.1|-8.5|||Mixed Models Analysis|||||-8.5|-13.1|<0.001
91767545|NCT05051579|183424137|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.9|||Mixed Models Analysis|||||-8.9|-13.5|<0.001
91553175|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-23.9|STANDARD_ERROR_OF_MEAN|14.79||0.1105|TWO_SIDED|90.0|-48.6|0.7|||Linear mixed-effects model||Change from Day -1 to Day 7|||0.7|-48.6|0.1105
91553176|NCT02865538|182992043|OTHER|Descriptive analysis|LS means difference|-18.4|STANDARD_ERROR_OF_MEAN|15.5||0.239|TWO_SIDED|90.0|-44.2|7.4|||Linear mixed-effects model||Change from Day -1 to Day 7|||7.4|-44.2|0.2390
91553177|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.837||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.837
91553178|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.428||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.428
91553179|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.269||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.269
91553180|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.015||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.015
91553181|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.163||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.163
91553182|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.14||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.140
91553183|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.079||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.079
91553184|NCT06946888|182992044|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.151||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.151
91553185|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.63||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.63
91553186|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.608||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.608
91553187|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.244||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.244
91553188|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.052||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.052
91553189|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.229||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.229
91553190|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.184||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.184
91767546|NCT05051579|183424138|OTHER||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-10.4|-4.3|||Mixed Models Analysis|||||-4.3|-10.4|<0.001
91767547|NCT05051579|183424138|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.2|-8.3|||Mixed Models Analysis|||||-8.3|-14.2|<0.001
91767548|NCT05051579|183424138|OTHER||LS Mean difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-14.7|-9.0|||Mixed Models Analysis|||||-9.0|-14.7|<0.001
91553191|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.148||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.148
91553192|NCT06946888|182992045|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.143||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.143
91553193|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.333||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.333
91553194|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.273||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.273
91767549|NCT05051579|183424138|OTHER||LS Mean difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-10.2|||Mixed Models Analysis|||||-10.2|-15.8|<0.001
91767550|NCT05051579|183424139|OTHER||LS Mean difference (Final Values)|-4.4||||0.002|TWO_SIDED|95.0|-7.2|-1.6|||Mixed Models Analysis|||||-1.6|-7.2|0.002
91767551|NCT05051579|183424139|OTHER||LS Mean difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-8.0|-2.4|||Mixed Models Analysis|||||-2.4|-8.0|<0.001
91767552|NCT05051579|183424139|OTHER||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.2|-3.8|||Mixed Models Analysis|||||-3.8|-9.2|<0.001
91767553|NCT05051579|183424139|OTHER||LS Mean difference (Final Values)|-8.7|||<|0.001|TWO_SIDED|95.0|-11.3|-6.0|||Mixed Models Analysis|||||-6.0|-11.3|<0.001
91767554|NCT05051579|183424140|OTHER||LS Mean difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.8|-2.4|||Mixed Models Analysis|||||-2.4|-8.8|<0.001
91767555|NCT05051579|183424140|OTHER||LS Mean difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.3|-4.0|||Mixed Models Analysis|||||-4.0|-10.3|<0.001
91767556|NCT05051579|183424140|OTHER||LS Mean difference (Final Values)|-6.6|||<|0.001|TWO_SIDED|95.0|-9.7|-3.6|||Mixed Models Analysis|||||-3.6|-9.7|<0.001
91767557|NCT05051579|183424140|OTHER||LS Mean difference (Final Values)|-9.6|||<|0.001|TWO_SIDED|95.0|-12.7|-6.6|||Mixed Models Analysis|||||-6.6|-12.7|<0.001
91767558|NCT05051579|183424141|OTHER||LS Mean difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.2|-1.6|||Mixed Models Analysis|||||-1.6|-3.2|<0.001
91767559|NCT05051579|183424141|OTHER||LS Mean difference (Final Values)|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.6|||Mixed Models Analysis|||||-2.6|-4.3|<0.001
91767560|NCT05051579|183424141|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.6|3.0|||Mixed Models Analysis|||||3.0|-4.6|<0.001
91767561|NCT05051579|183424141|OTHER||LS Mean difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.7|-3.1|||Mixed Models Analysis|||||-3.1|-4.7|<0.001
91767562|NCT05051579|183424142|OTHER||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.6|-1.5|||Mixed Models Analysis|||||-1.5|-3.6|<0.001
91767563|NCT05051579|183424142|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.8|-2.8|||Mixed Models Analysis|||||-2.8|-4.8|<0.001
91767564|NCT05051579|183424142|OTHER||LS Mean difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.2|-3.2|||Mixed Models Analysis|||||-3.2|-5.2|<0.001
91767565|NCT05051579|183424142|OTHER||LS Mean difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.6|-3.6|||Mixed Models Analysis|||||-3.6|-5.6|<0.001
91767566|NCT05051579|183424143|OTHER||Odds Ratio (OR)|9.96|||<|0.001|TWO_SIDED|95.0|3.61|27.44|||Regression, Logistic|||||27.44|3.61|<0.001
91767567|NCT05051579|183424143|OTHER||Odds Ratio (OR)|27.97|||<|0.001|TWO_SIDED|95.0|8.15|96.01|||Regression, Logistic|||||96.01|8.15|<0.001
91767568|NCT05051579|183424143|OTHER||Odds Ratio (OR)|27.36|||<|0.001|TWO_SIDED|95.0|8.71|85.91|||Regression, Logistic|||||85.91|8.71|<0.001
91553195|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.424||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.424
91553196|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.482||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.482
91553197|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.627||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.627
91553198|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.806||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.806
91553199|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.786||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.786
91767569|NCT05051579|183424143|OTHER||Odds Ratio (OR)|23.59|||<|0.001|TWO_SIDED|95.0|7.65|72.77|||Regression, Logistic|||||72.77|7.65|<0.001
91767570|NCT05051579|183424144|OTHER||Odds Ratio (OR)|19.93|||<|0.001|TWO_SIDED|95.0|3.47|114.4|||Regression, Logistic|||||114.40|3.47|<0.001
91767571|NCT05051579|183424144|OTHER||Odds Ratio (OR)|39.52|||<|0.001|TWO_SIDED|95.0|6.95|224.83|||Regression, Logistic|||||224.83|6.95|<0.001
91767572|NCT05051579|183424144|OTHER||Odds Ratio (OR)|74.97|||<|0.001|TWO_SIDED|95.0|13.16|427.18|||Regression, Logistic|||||427.18|13.16|<0.001
91767573|NCT05051579|183424144|OTHER||Odds Ratio (OR)|72.23|||<|0.001|TWO_SIDED|95.0|12.62|413.21|||Regression, Logistic|||||413.21|12.62|<0.001
91553200|NCT06946888|182992046|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.497||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.497
91553201|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.857||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.857
91553202|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.684||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.684
91553203|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.333||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.333
91767574|NCT05051579|183424145|OTHER||Odds Ratio (OR)|7.79|||<|0.001|TWO_SIDED|95.0|2.9|20.92|||Regression, Logistic|||||20.92|2.90|<0.001
91767575|NCT05051579|183424145|OTHER||Odds Ratio (OR)|25.07|||<|0.001|TWO_SIDED|95.0|7.49|83.91|||Regression, Logistic|||||83.91|7.49|<0.001
91767576|NCT05051579|183424145|OTHER||Odds Ratio (OR)|34.76|||<|0.001|TWO_SIDED|95.0|8.17|147.86|||Regression, Logistic|||||147.86|8.17|<0.001
91767577|NCT05051579|183424145|OTHER||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|8.15|96.29|||Regression, Logistic|||||96.29|8.15|<0.001
91767578|NCT05051579|183424146|OTHER||Odds Ratio (OR)|8.27|||<|0.001|TWO_SIDED|95.0|2.59|26.45|||Regression, Logistic|||||26.45|2.59|<0.001
91767579|NCT05051579|183424146|OTHER||Odds Ratio (OR)|15.64|||<|0.001|TWO_SIDED|95.0|4.83|50.68|||Regression, Logistic|||||50.68|4.83|<0.001
91767580|NCT05051579|183424146|OTHER||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|8.39|88.38|||Regression, Logistic|||||88.38|8.39|<0.001
91767581|NCT05051579|183424146|OTHER||Odds Ratio (OR)|20.88|||<|0.001|TWO_SIDED|95.0|6.59|66.17|||Regression, Logistic|||||66.17|6.59|<0.001
91767582|NCT00479713|183424154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|1.72|<=|0.001||95.0|-14.1|-7.33|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-7.33|-14.10|<=0.001
91767583|NCT00479713|183424155|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<=|0.001||95.0|1.5|3.0|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 100 mg/dL (2.59 mmol/L)||3.0|1.5|<=0.001
91767584|NCT00479713|183424155|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|||<=|0.001||95.0|1.8|4.4|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 70 mg/dL (1.81 mmol/L)||4.4|1.8|<=0.001
91767585|NCT00479713|183424156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|-9.56|-4.84|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-4.84|-9.56|<=0.001
91767586|NCT00479713|183424157|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.06||||0.056||95.0|-9.56|-0.3|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval (CI) based on Wilcoxon's rank.|||-0.30|-9.56|0.056
91767587|NCT00479713|183424158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|1.17||0.433||95.0|-3.21|1.38|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||1.38|-3.21|0.433
91767588|NCT00479713|183424159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|STANDARD_ERROR_OF_MEAN|1.58|<=|0.001||95.0|-12.5|-6.31|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-6.31|-12.50|<=0.001
91553204|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.09||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.090
91553205|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.545||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.545
91553206|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.251||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.251
91553207|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.701||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.701
91553208|NCT06946888|182992047|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.08||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.080
91553209|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.636||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.636
91553210|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.909||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.909
91553211|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.627||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.627
91553212|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.474||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.474
91553213|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.378||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.378
91553214|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.768||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.768
91767589|NCT00479713|183424160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|1.98|<=|0.001||95.0|-13.49|-5.69|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-5.69|-13.49|<=0.001
91767590|NCT00479713|183424161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|1.44|<=|0.001||95.0|-9.07|-3.43|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-3.43|-9.07|<=0.001
91767591|NCT00479713|183424162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.11|STANDARD_ERROR_OF_MEAN|1.43|<=|0.001||95.0|-10.91|-5.3|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-5.30|-10.91|<=0.001
91767592|NCT00479713|183424163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67||||0.172||95.0|-16.67|2.87|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free CI based on Wilcoxon's rank|||2.87|-16.67|0.172
91767593|NCT05274958|183424178|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Patient measures for both groups were first summarized descriptively with means and standard deviations. To compare the two groups, a t-test was used.||||<0.05
91767594|NCT02679287|183424225|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.0001|TWO_SIDED|95.0|1.2|2.4|||Mixed Models Analysis|||The null hypothesis is that there is no difference in percentage of time \<70 mg/dL in SAP vs. evening-overnight CLC session. Change in HbA1c during study sessions was used as a covariate of the model.||2.4|1.2|<0.0001
91767595|NCT03628976|183424251|SUPERIORITY|||||||0.0096|||||||ANOVA|||||||0.0096
91767596|NCT03628976|183424252|SUPERIORITY|||||||0.764|||||||ANOVA|||||||0.764
91767597|NCT03628976|183424253|SUPERIORITY|||||||0.446|||||||ANOVA|||||||0.446
91767598|NCT00851786|183424255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.45|0.69||The p-value was adjusted for baseline gpELISA titer, measurement time (week 6 vs. week 12), CD4 stratum and age.|Linear mixed effect model|Natural log transformed gpELISA titers after one or two doses of vaccine was modeled.||Null hypothesis: VZV antibody titer measured by gpELISA, after 1 or 2 doses of ZOSTAVAX/placebo is the same between ZOSTAVAX arm and the placebo arm||0.69|0.45|<.001
91767599|NCT01405768|183424282|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
91767600|NCT01405768|183424284|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
91767601|NCT00599872|183424292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.418|||<|0.05|TWO_SIDED|95.0|-1.15|0.48|||ANCOVA|||||0.48|-1.15|<0.05
91767602|NCT00599872|183424293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|||<|0.05|TWO_SIDED|95.0|-1.72|0.63|||ANCOVA|||||0.63|-1.72|<0.05
91553215|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.909||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.909
91553216|NCT06946888|182992048|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.449||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.449
91553217|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.593||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.593
91553218|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.994||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.994
91767603|NCT00387881|183424303|SUPERIORITY_OR_OTHER||Percent difference|18.0|||<|0.001||95.0|10.0|25.0||Endpoints were co-primary and both needed to have p-value of \<0.05 to be considered indicative of efficacy.|Cochran-Mantel-Haenszel||Analysis for Migraine Pain-Free at 2 hours Post-Dose|Pain-Free (2 hours)||25|10|<0.001
91767604|NCT00387881|183424303|SUPERIORITY_OR_OTHER||Percent difference|15.0|||<|0.001||95.0|8.0|22.0|||Cochran-Mantel-Haenszel||Analysis for Sustained Pain Free from 2-24 hours Post-dose|Sustained Pain-Free (2-24 hours)||22|8|<0.001
91767605|NCT00453154|183424313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis|Hazard Ratio (HR)|1.62||||0.02|TWO_SIDED|70.0|1.27|2.08||All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (\< 6 vs 6 cycles)|Log Rank|||||2.08|1.27|0.02
91767606|NCT03629886|183424326|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.15|||||TWO_SIDED|95.0|0.09|0.23||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=1963). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.23|0.09|
91553219|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.959||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.959
91553220|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.946||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.946
91553221|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.715||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.715
91553222|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.422||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.422
91553223|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.379||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.379
91553224|NCT06946888|182992049|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.302||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.302
91767607|NCT03629886|183424326|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88|||||TWO_SIDED|95.0|0.73|1.05||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=1917). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.05|0.73|
91553225|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.913||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.913
91553226|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.802||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.802
91553227|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.605||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.605
91553228|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.35||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized Estimating Equations were used to analyze repeated measures data and to assess the interaction effect between group and time. Potential interfering factors such as age and years of work experience were controlled during the analysis, and the effect size (Cohen's d) and its 95% confidence interval were calculated to assist in interpreting the clinical significance. Statistical analysis was performed using SPSS version XX or R version XX, and the significance level was set at p \< 0.05.||||0.350
91553229|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||1||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||1.000
91553230|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.744||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.744
91767608|NCT03629886|183424326|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.09|||||TWO_SIDED|95.0|0.05|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2356). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.15|0.05|
91553231|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.202||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.202
91553232|NCT06946888|182992050|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.918||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.918
91553233|NCT05423730|182992055|SUPERIORITY||Mean Difference (Final Values)|-11.12|||||TWO_SIDED|95.0|-49.75|57.2|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||57.20|-49.75|
91553234|NCT05423730|182992056|SUPERIORITY||Mean Difference (Final Values)|7.65|||||TWO_SIDED|95.0|-47.96|63.9|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||63.90|-47.96|
91553235|NCT05423730|182992057|SUPERIORITY||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.95|0.67|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||0.67|-1.95|
91553236|NCT05423730|182992058|SUPERIORITY||Mean Difference (Final Values)|13.83|||||TWO_SIDED|95.0|-9.45|43.09|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||43.09|-9.45|
91553237|NCT05423730|182992059|SUPERIORITY||Mean Difference (Final Values)|11.42|||||TWO_SIDED|95.0|-3.31|28.4|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||28.40|-3.31|
91553238|NCT05423730|182992060|SUPERIORITY||Mean Difference (Final Values)|12.57|||||TWO_SIDED|95.0|-0.77|27.69|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||27.69|-0.77|
91553239|NCT05423730|182992061|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-21.92|21.24|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||21.24|-21.92|
91553240|NCT03550170|182992062|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|4.89|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|90.0|0.67|9.11|||||Comparison of teleconference to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||9.11|0.67|
91553241|NCT03550170|182992062|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|6.12|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|90.0|0.98|11.26|||||Comparison of internet to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||11.26|0.98|
91553242|NCT03550170|182992063|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
91553243|NCT05850052|182992069|SUPERIORITY||Odds Ratio (OR)|1.24||||0.26|TWO_SIDED|95.0|0.85|1.79|||proportional-odds cumulative logit model|||||1.79|0.85|0.26
91553244|NCT05850052|182992070|SUPERIORITY||incidence rate ratio|1.02||||0.86|TWO_SIDED|97.5|0.82|1.27|||proportional-odds cumulative logit model|||||1.27|0.82|0.86
91553245|NCT05850052|182992071|SUPERIORITY||Risk Ratio (RR)|3.1||||0.36|TWO_SIDED|95.0|0.32|30.0|||Fisher Exact|||||30|0.32|0.36
91553246|NCT06037668|182992111|SUPERIORITY|||||||0.1134||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1134
91553247|NCT06037668|182992112|SUPERIORITY|||||||0.0031||||||p-values are calculated by independent t-test|Independent t-test|||||||0.003100
91553248|NCT06037668|182992113|SUPERIORITY|||||||0.0503||||||p-values are calculated by independent t-test|Independent t-test|||||||0.050300
91553249|NCT06037668|182992114|SUPERIORITY|||||||0.1178||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1178
91553250|NCT06037668|182992115|SUPERIORITY|||||||0.1003||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1003
91553251|NCT06037668|182992116|SUPERIORITY|||||||0.4832||||||p-values are calculated by independent t-test|Independent t-test|||||||0.4832
91553252|NCT04881461|182992123|SUPERIORITY||Mean Difference (Final Values)|1.88||||0.0036|TWO_SIDED|95.0|0.6|3.17||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand."||3.17|0.60|0.0036
91553253|NCT04881461|182992124|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.1111|TWO_SIDED|95.0|-0.04|0.39||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction.|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand."||0.39|-0.04|0.1111
91553254|NCT04881461|182992125|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.0417|TWO_SIDED|95.0|-0.01|2.67||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.67|-0.01|0.0417
91553255|NCT04881461|182992126|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.4984|TWO_SIDED|95.0|-0.15|0.3||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.30|-0.15|0.4984
91553256|NCT04881461|182992127|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.4438|TWO_SIDED|95.0|-0.12|0.27||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.27|-0.12|0.4438
91553257|NCT04881461|182992128|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.0363|TWO_SIDED|95.0|0.01|0.38||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.38|0.01|0.0363
91553258|NCT04881461|182992129|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.0329|TWO_SIDED|95.0|0.06|2.31||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.."||2.31|0.06|0.0329
91553259|NCT04881461|182992130|SUPERIORITY||Mean Difference (Final Values)|1.73||||0.0016|TWO_SIDED|95.0|0.66|2.79||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.79|0.66|0.0016
91553260|NCT04881461|182992131|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4502|TWO_SIDED|95.0|-0.42|0.92||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.92|-0.42|0.4502
91553261|NCT04881461|182992132|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.1177|TWO_SIDED|95.0|-0.14|1.23||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.23|-0.14|0.1177
91553262|NCT04881461|182992133|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.4604|TWO_SIDED|95.0|-0.37|0.79||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.79|-0.37|0.4604
91553263|NCT04881461|182992134|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.0549|TWO_SIDED|95.0|-0.01|1.15||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.15|-0.01|0.0549
91553264|NCT04881461|182992135|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0049|TWO_SIDED|95.0|0.3|1.93||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.93|0.30|0.0049
91553265|NCT04881461|182992136|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.0004|TWO_SIDED|95.0|0.54|1.95||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.95|0.54|0.0004
91553266|NCT04881461|182992137|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0054|TWO_SIDED|95.0|0.25|1.63||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.63|0.25|0.0054
91553267|NCT04881461|182992138|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0002|TWO_SIDED|95.0|0.52|1.71||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.71|0.52|0.0002
91553268|NCT03988621|182992139|SUPERIORITY||Mean Difference (Net)|-0.65||||0.04|TWO_SIDED|95.0|-1.27|-0.03||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean HSCN scale scores of participants in the intervention group were estimated to decrease by 0.65 (95% CI: -1.27 to -0.03) units more than that of participants in the control group from baseline to 6-months.|||-0.03|-1.27|0.04
91553269|NCT03988621|182992140|SUPERIORITY||Mean Difference (Net)|5.05||||0.01|TWO_SIDED|95.0|1.12|8.98||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Self Care Inventory scale scores of participants in the intervention group were estimated to increase by 5.05 (95% CI: 1.12 to 8.98) units more than that of participants in the control group from baseline to 6-months.|||8.98|1.12|0.01
91553270|NCT03988621|182992141|SUPERIORITY||Mean Difference (Net)|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.48|-2.52||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean PSS scale scores of participants in the intervention group were estimated to decrease by 4.50 (95% CI: -6.48 to -2.52) units more than that of participants in the control group from baseline to 6-months.|||-2.52|-6.48|<0.0001
91767609|NCT03629886|183424326|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.44|||||TWO_SIDED|95.0|0.35|0.56||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2357). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.56|0.35|
91553271|NCT03988621|182992142|SUPERIORITY||Mean Difference (Net)|2.16||||0.099|TWO_SIDED|95.0|-0.41|4.73||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Active Coping Subscale||4.73|-0.41|0.099
91553272|NCT03988621|182992142|SUPERIORITY||Mean Difference (Net)|-0.88||||0.25|TWO_SIDED|95.0|-2.38|0.62||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Estimated difference may not be consistent with difference sample means presented in outcome measure data table.|Avoidance Coping Subscale||0.62|-2.38|0.25
91553273|NCT03988621|182992142|SUPERIORITY|The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mean Difference (Net)|-0.31||||0.68|TWO_SIDED|95.0|-1.81|1.18|||Mixed Models Analysis|||Minimization Coping Subscale||1.18|-1.81|0.68
91553274|NCT03988621|182992143|SUPERIORITY||Mean Difference (Net)|-1.32||||0.27|TWO_SIDED|95.0|-3.68|1.04||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Physical Health Score||1.04|-3.68|0.27
91553275|NCT03988621|182992143|SUPERIORITY||Mean Difference (Net)|3.35||||0.04|TWO_SIDED|95.0|0.17|6.53||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Mental Health scores of participants in the intervention group were estimated to increase by 3.35 (95% CI: 0.17 to 6.53) units more than that of participants in the control group from baseline to 6-months.|Mental Health Score||6.53|0.17|0.04
91553276|NCT03988621|182992146|SUPERIORITY||Mean Difference (Final Values)|1.3472||||0.5433|TWO_SIDED|95.0|0.5153|3.5218|||Regression, zero inflated poisson||Estimation accounts for the zero-inflated distribution of hospitalization count, thus estimate is inconsistent with mean values in the Outcome Measure Data table|||3.5218|0.5153|0.5433
91553277|NCT03988621|182992147|SUPERIORITY||Mean Difference (Final Values)|1.0143||||0.9173|TWO_SIDED|95.0|0.7766|1.3247|||Zero-inflated poisson regression|||||1.3247|0.7766|0.9173
91553278|NCT03988621|182992148|SUPERIORITY|||||||0.6486|||||||Fisher Exact|||||||0.6486
91553279|NCT03988621|182992149|SUPERIORITY|||||||0.6791|||||||t-test, 2 sided|||||||0.6791
91553280|NCT06356285|182992171|EQUIVALENCE|Quasibinominal models were used as the outcomes are bounded count variables. Accepting a two-sided p-value adjusted for 3 comparisons, the study was designed with 80% power to detect a minimal detectable effect size between the trial arms and control for the primary outcome.|Odds Ratio, log|0.05||||0.017|TWO_SIDED|95.0||||A two-sided p-value, as shown in the table, which was adjusted for 3 comparisons|Quasibinominal regression|||||||0.017
91553281|NCT05265065|182992175|NON_INFERIORITY|"Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.~The sample size calculation assumed an estimated seroresponse rate of 95% in both half- and full-dose arms, a non- inferiority margin of -10% (absolute difference), a one-sided significance level of5%, and no loss to follow- up. Under this scenario, a sample size of 100 per arm provides 90% power to compare seroresponse rates between arms under the non-inferiority framework."|Risk Difference (RD)|-2.9|||||TWO_SIDED|95.0|-7.7|2.0|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.||2.0|-7.7|
91553282|NCT05265065|182992177|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-16.1|11.3|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||11.3|-16.1|
91553283|NCT05265065|182992177|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-9.5|3.2|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||3.2|-9.5|
91553284|NCT05265065|182992177|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-17.1|16.1|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||16.1|-17.1|
91553285|NCT05265065|182992178|SUPERIORITY||Geometric Mean Ratio|0.94||||0.228|TWO_SIDED|95.0|0.86|1.04|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.04|0.86|0.228
91553286|NCT05265065|182992179|SUPERIORITY||Geometric Mean Ratio|0.94||||0.537|TWO_SIDED|95.0|0.77|1.15|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.15|0.77|0.537
91553287|NCT05265065|182992179|SUPERIORITY||Geometric Mean Ratio|0.99||||0.922|TWO_SIDED|95.0|0.89|1.11|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.11|0.89|0.922
91553288|NCT05265065|182992179|SUPERIORITY||Geometric Mean Ratio|0.71||||0.014|TWO_SIDED|95.0|0.54|0.93|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||0.93|0.54|0.014
91553289|NCT04778410|182992197|SUPERIORITY|||||||0.1794|||||||One Group Chi-Square test|The p-value was based on one group Chi-Square test for the null hypothesis CR rate was 0.19 at one-sided alpha of 0.1 in Cohort 2.||||||0.1794
91553290|NCT01385202|182992261|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|70.2|||<|0.0001|TWO_SIDED|95.0|60.9|78.4||In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.|Fisher Exact|The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p\<0.0001).|The confidence intervals above are the 95% exact binomial confidence intervals.|The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.||78.4|60.9|<0.0001
91553291|NCT01385202|182992261|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|74.0|||||TWO_SIDED|95.0|66.0|82.0|||||The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.|||82|66|
91553292|NCT01223352|182992301|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.85|||||TWO_SIDED|95.0|0.61|1.2||No statistical test of hypothesis was set for this study. The analysis of PK data was carried out descriptively|||b.i.d. bosentan regimen was taken as reference|||1.20|0.61|
91553293|NCT01223352|182992302|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.71|||||TWO_SIDED|95.0|0.48|1.05||No statistical hypothesis tests were set for this study. The analysis of PK data was carried out descriptively.|||b.i.d. bosentan regimen was taken as reference|||1.05|0.48|
91553294|NCT04068792|182992332|OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|90.0|-4.467|2.416||||||||2.416|-4.467|
91553295|NCT02577354|182992364|SUPERIORITY|||||||0.138||||||The threshold for statistical significance was p=0.05|Wald asymptotic test of proportions|Cui p-value adjustment for sample size re-estimation at interim analysis; Multiple imputation utilized for 3 participants lost to follow-up.||||||0.138
91553296|NCT02577354|182992365|SUPERIORITY|||||||0.032||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.032
91553297|NCT02577354|182992366|SUPERIORITY|||||||0.0499||||||The threshold for significance was p=0.05.|Friedman's regression analysis|Multiple Imputation utilized for 3 participants lost to follow-up.||||||0.0499
91553298|NCT02577354|182992368|SUPERIORITY|||||||0.011||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.011
91553299|NCT02577354|182992369|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.009
91553300|NCT02577354|182992370|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was 0.05|t-test, 2 sided|||||||<0.001
91553301|NCT02577354|182992371|SUPERIORITY|||||||0.003||||||Threshold for statistical significance was p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.003
91553302|NCT02577354|182992372|SUPERIORITY|||||||0.335||||||Threshold for statistical significance was p=0.05.|Chi-squared|||||||0.335
91553303|NCT02577354|182992380|SUPERIORITY|||||||0.048||||||The threshold for statistical significance was p=0.05.|Wald asymptotic test of proportions|Multiple imputation used for three participants lost to follow-up.||||||0.048
91767610|NCT03629886|183424326|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.2|||||TWO_SIDED|95.0|0.14|0.27||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2534). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.27|0.14|
91767611|NCT03629886|183424326|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2547). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.18|0.88|
91553304|NCT02577354|182992381|SUPERIORITY||||||<|0.001||||||"P-value for Satisfied with Treatment. Threshold for statistical significance was p=0.05"|Cochran-Mantel-Haenszel|||||||<0.001
91553305|NCT02577354|182992383|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||<0.001
91553306|NCT04173247|182992390|OTHER|A t-test with 180 degrees of freedom to compare the mean DLQI score over the 6 weeks in arm1 to the mean DLQI score over six weeks in arm2.||||||0.28|||||||t-test, 1 sided|||||||0.28
91553307|NCT04214834|182992402|SUPERIORITY||Mean Difference (Final Values)|2.96|||<|0.001|TWO_SIDED|95.0|1.7|4.29|||Mixed Models Analysis||Given that the model was on the log scale, mean difference and 95% confidence interval were derived from 1,000 bootstrap resamples.|A logarithmic transformation was applied to the outcome, centers were added as random effects to account for variation between them.||4.29|1.70|<0.001
91553308|NCT06097494|182992412|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|1.01|1.15|||||Calculated as the odds of a person diagnosed with vitiligo having with depression versus people not diagnosed with vitiligo|||1.15|1.01|
91553309|NCT06097494|182992413|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.09|1.3|||||Calculated as the odds of people diagnosed with vitiligo having anxiety compared to people not diagnosed with vitilligo.|||1.30|1.09|
91553310|NCT06097494|182992414|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.03|1.17|||||Calculated as the odds of people diagnosed with vitiligo having anxiety or depression compared to people not diagnosed with vitilligo.|||1.17|1.03|
91553311|NCT06097494|182992415|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.26|1.32|||||Adjusted incident rate ratio for increased primary care use was calculated by comparing patients with vitiligo versus matched controls not having vitiligo,using negative binomial regression.|||1.32|1.26|
91553312|NCT06097494|182992417|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.2|||||Hazard ratios for mental health referrals was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.20|0.93|
91553313|NCT06097494|182992418|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.76|1.15|||||Hazard ratios for unemployment was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.15|0.76|
91553314|NCT06097494|182992419|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.06|1.24|||||Hazard ratios for time off work was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.24|1.06|
91553315|NCT06097494|182992420|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.02|1.31|||||Hazard ratios for sleep disturbance was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.31|1.02|
91553316|NCT05683158|182992442|OTHER||Mean Difference (Net)|1.71|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||ANOVA||Mean difference between two groups of movement unit in forward direction|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
91553317|NCT05683158|182992442|OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||ANOVA||Statistics difference among forward, ipsilateral and contralateral directions in within group|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
91553318|NCT04109066|182992456|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0021|TWO_SIDED|95.0|1.29|3.27|||Cochran-Mantel-Haenszel||"Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.~Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method."|Arm A over Arm B||3.27|1.29|0.0021
91553319|NCT04109066|182992456|OTHER||Adjusted Difference of pCR Rates|10.5|||||TWO_SIDED|95.0|4.0|16.9|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||16.9|4.0|
91553320|NCT04109066|182992457|SUPERIORITY||Odds Ratio (OR)|3.11|||||TWO_SIDED|95.0|1.58|6.11|||||Stratified by AC Dose-Frequency. Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.|Arm A over Arm B||6.11|1.58|
91553321|NCT04109066|182992457|OTHER||Adjusted Difference of pCR Rates|24.1|||||TWO_SIDED|95.0|10.7|37.5|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||37.5|10.7|
91553322|NCT04244175|182992518|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.11|||=|0.986|TWO_SIDED|90.0|-10.38|10.61|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||10.61|-10.38|=0.986
91553323|NCT04244175|182992518|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|1.42|||=|0.823|TWO_SIDED|90.0|-9.04|11.87|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||11.87|-9.04|=0.823
91767612|NCT03629886|183424327|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.19|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2818). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.19|
91553324|NCT04244175|182992518|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.76|||=|0.888|TWO_SIDED|90.0|-8.23|9.76|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||9.76|-8.23|=0.888
91553325|NCT04244175|182992519|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|4.9|||||TWO_SIDED|90.0|-12.0|19.3||||||CVL-865 25 mg BID vs Placebo||19.3|-12.0|
91553326|NCT04244175|182992519|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|1.4|||||TWO_SIDED|90.0|-16.1|16.2||||||CVL-865 7.5 mg BID vs Placebo||16.2|-16.1|
91553327|NCT04244175|182992519|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|3.2|||||TWO_SIDED|90.0|-11.4|15.8||||||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||15.8|-11.4|
91553328|NCT04244175|182992520|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.27|||=|0.587|TWO_SIDED|90.0|0.616|2.618|||Regression, Logistic|||CVL-865 25 mg BID vs Placebo||2.618|0.616|=0.587
91553329|NCT04244175|182992520|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.303|||=|0.554|TWO_SIDED|90.0|0.624|2.723|||Regression, Logistic|||CVL-865 7.5 mg BID vs Placebo||2.723|0.624|=0.554
91553330|NCT04244175|182992520|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.286|||=|0.513|TWO_SIDED|90.0|0.684|2.42|||Regression, Logistic|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.420|0.684|=0.513
91553331|NCT04244175|182992521|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||>|0.999|||||||Fisher's exact test|||CVL-865 25 mg BID vs Placebo||||>0.999
91553332|NCT04244175|182992521|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.618|||||||Fisher's exact test|||CVL-865 7.5 mg BID vs Placebo||||=0.618
91553333|NCT04244175|182992521|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.422|||||||Fisher's exact test|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||||=0.422
91553334|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.021|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.1|-0.8|=0.021
91553335|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.342|TWO_SIDED|90.0|-0.5|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.5|=0.342
91553336|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.059|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.0|-0.6|=0.059
91553337|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.04|TWO_SIDED|90.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.1|-0.9|=0.040
91553338|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.152|TWO_SIDED|90.0|-0.8|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.1|-0.8|=0.152
91553339|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.044|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.8|=0.044
91553340|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.199|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.199
91553341|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.171|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.171
91553342|NCT04244175|182992523|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.125|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.125
91553343|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.767|TWO_SIDED|90.0|-0.3|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||0.2|-0.3|=0.767
91553344|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.2|||=|0.178|TWO_SIDED|90.0|0.0|0.5|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.5|0.0|=0.178
91553345|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.542|TWO_SIDED|90.0|-0.1|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.3|-0.1|=0.542
91553346|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.106|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||0.0|-0.6|=0.106
91553347|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.663|TWO_SIDED|90.0|-0.2|0.4|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.4|-0.2|=0.663
91553348|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.488|TWO_SIDED|90.0|-0.4|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||0.2|-0.4|=0.488
91553349|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.1|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.100
91553350|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.969|TWO_SIDED|90.0|-0.3|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.3|-0.3|=0.969
91553351|NCT04244175|182992524|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.344|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.1|-0.4|=0.344
91553352|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.01|TWO_SIDED|90.0|-0.7|-0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.2|-0.7|=0.010
91553353|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.376|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.4|=0.376
91553354|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.044|TWO_SIDED|90.0|-0.5|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||-0.1|-0.5|=0.044
91553355|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.3|-1.0|=0.005
91553356|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.2|-0.5|=0.549
91553357|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.7|=0.048
91553358|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||-0.3|-1.0|=0.005
91553359|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.2|-0.5|=0.549
91553360|NCT04244175|182992525|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||-0.1|-0.7|=0.048
91553361|NCT04244175|182992526|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.49|||=|0.829|TWO_SIDED|90.0|-4.23|3.26|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||3.26|-4.23|=0.829
91553362|NCT04244175|182992526|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.2|||=|0.927|TWO_SIDED|90.0|-3.87|3.46|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||3.46|-3.87|=0.927
91553363|NCT04244175|182992526|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.35|||=|0.859|TWO_SIDED|90.0|-3.57|2.88|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.88|-3.57|=0.859
91553364|NCT04244175|182992527|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.013|||=|0.788|TWO_SIDED|90.0|-0.096|0.069|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-2)|CVL-865 25 mg BID vs Placebo (HUI-2)||0.069|-0.096|=0.788
91553365|NCT04244175|182992527|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.077|||=|0.126|TWO_SIDED|90.0|-0.006|0.16|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID vs Placebo (HUI-2)||0.160|-0.006|=0.126
91553366|NCT04244175|182992527|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.032|||=|0.461|TWO_SIDED|90.0|-0.039|0.103|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-2)||0.103|-0.039|=0.461
91553367|NCT04244175|182992527|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.032|||=|0.661|TWO_SIDED|90.0|-0.154|0.089|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-3)|CVL-865 25 mg BID vs Placebo (HUI-3)||0.089|-0.154|=0.661
91553368|NCT04244175|182992527|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.115|||=|0.124|TWO_SIDED|90.0|-0.008|0.237|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID vs Placebo (HUI-3)||0.237|-0.008|=0.124
91553369|NCT04244175|182992527|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.041|||=|0.518|TWO_SIDED|90.0|-0.064|0.146|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-3)||0.146|-0.064|=0.518
91553370|NCT03636490|182992536|OTHER|We tested an association between change in urinary sodium excretion rate with stress and ratio of awake-to-asleep urinary sodium excretion rate.|unstandardized B coefficients|0.0021||||0.0032||95.0|0.0007|0.0034|||Regression, Linear|Adjusted for age, sex, race, ethnicity, body mass index, mean DBP during the baseline period, and 24-hour creatinine clearance.||||0.0034|0.0007|0.0032
91553371|NCT03636490|182992537|OTHER|We tested an association between ratio of awake-to-asleep urinary sodium excretion rate and SBP dipping.|unstandardized B coefficients|0.8244||||0.037||95.0|0.0487|1.6|||Regression, Linear|Adjusted for age, sex, race, ethnicity, BMI, smoking, alcohol use, glucose, 24-hr sodium and potassium excretion, 24-hr creat clear, and FENa|Data are unstandardized B coefficients (95% CI)|||1.6000|0.0487|0.037
91553372|NCT02997202|182992578|SUPERIORITY||Hazard Ratio (HR)|0.679||||0.0518|TWO_SIDED|95.0|0.459|1.005|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.005|0.459|0.0518
91553373|NCT02997202|182992579|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.4394|TWO_SIDED|95.0|0.554|1.293|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.293|0.554|0.4394
91553374|NCT02997202|182992582|SUPERIORITY||Hazard Ratio (HR)|2.308||||0.0209|TWO_SIDED|95.0|1.1352|4.6922|||Fine-Grays Model|||Based on Fine \& Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||4.6922|1.1352|0.0209
91553375|NCT02997202|182992583|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6417|TWO_SIDED|95.0|0.686|1.261|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.261|0.686|0.6417
91553376|NCT02997202|182992584|SUPERIORITY||Hazard Ratio (HR)|0.8938||||0.641|TWO_SIDED|95.0|0.5574|1.433|||Fine-Grays model|||"aGVHD II to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||1.4330|0.5574|0.6410
91553377|NCT02997202|182992584|SUPERIORITY||Hazard Ratio (HR)|1.4254||||0.4128|TWO_SIDED|95.0|0.6103|3.3289|||Fine-Grays model|||"aGVHD III to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||3.3289|0.6103|0.4128
91553378|NCT02997202|182992585|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
91553379|NCT02997202|182992586|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
91553380|NCT02997202|182992587|SUPERIORITY||Hazard Ratio (HR)|3.4537||||0.2029|TWO_SIDED|95.0|0.5126|23.2687|||Fine-Grays Model|||MRD Eradication||23.2687|0.5126|0.2029
91553381|NCT02997202|182992587|SUPERIORITY||Hazard Ratio (HR)|0.7073||||0.4077|TWO_SIDED|95.0|0.3116|1.6055|||Fine-Grays Model|||MRD 10\^-4 Detection||1.6055|0.3116|0.4077
91553382|NCT02997202|182992588|SUPERIORITY||Hazard Ratio (HR)|0.3729|||<|0.001|TWO_SIDED|95.0|0.2243|0.6199|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||0.6199|0.2243|<0.001
91553383|NCT02997202|182992589|SUPERIORITY||Hazard Ratio (HR)|1.4848||||0.0568|TWO_SIDED|95.0|0.9886|2.23|||Fine-Grays model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||2.2300|0.9886|0.0568
91553384|NCT04084574|182992603|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_DEVIATION|13.5||0.3968|TWO_SIDED|95.0|-16.8|6.9||The threshold for statistical significance is p = 0.05|t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||6.9|-16.8|0.3968
91553385|NCT04084574|182992604|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.5||0.07926|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||0.44|-0.33|0.07926
91553386|NCT04084574|182992606|SUPERIORITY||Mean Difference (Net)|11.7|STANDARD_DEVIATION|59.3||0.0673|TWO_SIDED|95.0|-34.2|58.6|||t-test, 2 sided|||||58.6|-34.2|0.0673
91553387|NCT04084574|182992607|SUPERIORITY||Mean Difference (Net)|-10.7|STANDARD_DEVIATION|189.3||0.8821|TWO_SIDED|95.0|-157.8|136.4|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||136.4|-157.8|0.8821
91553388|NCT04084574|182992608|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|3.3||0.6479|TWO_SIDED|95.0|-2.0|3.1|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||3.1|-2.0|0.6479
91553389|NCT04084574|182992609|SUPERIORITY||Mean Difference (Net)|7.0|STANDARD_DEVIATION|21.8||0.4044|TWO_SIDED|95.0|-10.0|24.0|||t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Behavioral Diet Counseling group minus Standard of Care group.|||24.0|-10.0|0.4044
91553390|NCT04084574|182992610|SUPERIORITY||Mean Difference (Net)|1.34|STANDARD_DEVIATION|2.91||0.2374|TWO_SIDED|95.0|-0.97|3.6|||t-test, 2 sided|||||3.60|-0.97|0.2374
91553391|NCT04084574|182992611|SUPERIORITY||Mean Difference (Net)|-2.69|STANDARD_DEVIATION|13.62||0.6188|TWO_SIDED|95.0|-13.71|8.33|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||8.33|-13.71|0.6188
91553392|NCT04084574|182992612|SUPERIORITY||Mean Difference (Net)|-1.39|STANDARD_DEVIATION|1.79||0.0546|TWO_SIDED|95.0|-2.82|0.03|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.03|-2.82|0.0546
91553393|NCT04084574|182992613|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.2||1|TWO_SIDED|95.0|-0.98|0.98|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.98|-0.98|1.00
91553394|NCT04084574|182992614|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|1.5||1|TWO_SIDED|95.0|-0.89|1.49|||t-test, 2 sided|||||1.49|-0.89|1.00
91553395|NCT04631016|182992641|OTHER||LS Mean Difference|0.024||||0.216|TWO_SIDED|80.0|-0.015|0.063|||Mixed Models Analysis|||||0.063|-0.015|0.216
91553396|NCT04631016|182992644|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.186|TWO_SIDED|80.0|0.57|1.11|||Regression, Cox|||||1.11|0.57|0.186
91553397|NCT04631016|182992665|SUPERIORITY||Least square mean difference|0.067||||0.044|TWO_SIDED|80.0|0.017|0.116||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the mixed model for repeated measures (MMRM) analysis at Week 12.||0.116|0.017|0.044
91553398|NCT04631016|182992665|SUPERIORITY||Least square mean difference|0.07||||0.036|TWO_SIDED|80.0|0.02|0.12||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the MMRM analysis at Week 28.||0.120|0.020|0.036
91553399|NCT04967599|182992680|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||.81
91553400|NCT04967599|182992681|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||||||.46
91553401|NCT04967599|182992682|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
91553402|NCT04967599|182992683|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||.59
91553403|NCT04967599|182992684|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||.29
91553404|NCT04967599|182992685|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||.49
91553405|NCT04704869|182992718|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
91553406|NCT04490109|182992747|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0148|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0148
91553407|NCT04490109|182992747|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0143|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0143
91553408|NCT04490109|182992749|SUPERIORITY|||||||0.0205|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0205
91553409|NCT04490109|182992750|SUPERIORITY|||||||0.0044|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0044
91553410|NCT04490109|182992750|SUPERIORITY|||||||0.0077|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0077
91553411|NCT04490109|182992751|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0400
91553412|NCT04490109|182992751|SUPERIORITY|||||||0.0486|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0486
91553413|NCT04490109|182992753|SUPERIORITY|||||||0.0246|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0246
91553414|NCT04490109|182992753|SUPERIORITY|||||||0.0366|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0366
91553415|NCT04490109|182992754|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0467
91553416|NCT04490109|182992755|SUPERIORITY|||||||0.0293|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0293
91553417|NCT04490109|182992756|SUPERIORITY|||||||0.0045|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0045
91553418|NCT04490109|182992756|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0043
91553419|NCT04490109|182992757|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0026
91553420|NCT04490109|182992757|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0005
91553421|NCT04490109|182992758|SUPERIORITY|||||||0.0348|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0348
91553422|NCT04490109|182992758|SUPERIORITY|||||||0.0173|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0173
91553423|NCT04490109|182992759|SUPERIORITY|||||||0.0228|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0228
91553424|NCT04490109|182992759|SUPERIORITY|||||||0.0015|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0015
91553425|NCT04490109|182992760|SUPERIORITY|||||||0.0003|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0003
91553426|NCT04490109|182992761|SUPERIORITY|||||||0.0195|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0195
91553427|NCT04490109|182992762|SUPERIORITY|||||||0.0365|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0365
91553428|NCT04490109|182992763|SUPERIORITY|||||||0.0086|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0086
91553429|NCT04490109|182992763|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0035
91553430|NCT04490109|182992764|SUPERIORITY|||||||0.0074|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0074
91553431|NCT04490109|182992764|SUPERIORITY|||||||0.0008|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0008
91553432|NCT04163991|182992765|SUPERIORITY||Least Squares (LS) Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.0296|TWO_SIDED|90.0|-1.47|-0.21||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.21|-1.47|0.0296
91553433|NCT04163991|182992765|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0355|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0355
91553434|NCT04163991|182992765|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0364|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0364
91553435|NCT04163991|182992765|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.38||0.0478|TWO_SIDED|90.0|-1.41|-0.13||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.13|-1.41|0.0478
91553436|NCT04163991|182992776|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0584|TWO_SIDED|90.0|0.43|0.94||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.94|0.43|0.0584
91553437|NCT04163991|182992776|OTHER||Ratio of geometric mean versus placebo|0.76||||0.2274|TWO_SIDED|90.0|0.51|1.11||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.11|0.51|0.2274
91553438|NCT04163991|182992776|SUPERIORITY||Ratio of geometric mean versus placebo|0.77||||0.2794|TWO_SIDED|90.0|0.52|1.14||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.14|0.52|0.2794
91553439|NCT04163991|182992776|SUPERIORITY||Ratio of geometric mean versus placebo|0.57||||0.0199|TWO_SIDED|90.0|0.39|0.85||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.85|0.39|0.0199
91553440|NCT04163991|182992777|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0007|TWO_SIDED|90.0|0.52|0.79||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.79|0.52|0.0007
91553441|NCT04163991|182992777|SUPERIORITY||Ratio of geometric mean versus placebo|0.62||||0.0003|TWO_SIDED|90.0|0.5|0.76||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.76|0.50|0.0003
91553442|NCT04163991|182992777|SUPERIORITY||Ratio of geometric mean versus placebo|0.6||||0.0001|TWO_SIDED|90.0|0.48|0.74||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.74|0.48|0.0001
91553443|NCT04163991|182992777|SUPERIORITY||Ratio of geometric mean versus placebo|0.47|||<|0.0001|TWO_SIDED|90.0|0.38|0.59||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.59|0.38|< 0.0001
91553444|NCT04163991|182992778|SUPERIORITY||Odds Ratio (OR)|1.4||||0.775|TWO_SIDED|90.0|0.2|8.0||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||8.0|0.2|0.7750
91553445|NCT04163991|182992778|SUPERIORITY||Odds Ratio (OR)|0.6||||0.6974|TWO_SIDED|90.0|0.1|5.5||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||(Lower limit of 90% CI is \< 0.1.) Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.5|0.1|0.6974
91553446|NCT04163991|182992778|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9318|TWO_SIDED|90.0|0.1|5.7||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.7|0.1|0.9318
91553447|NCT04163991|182992778|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9108|TWO_SIDED|90.0|0.2|5.1||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.1|0.2|0.9108
91767613|NCT03629886|183424327|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.21|||||TWO_SIDED|95.0|1.06|1.37||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2815). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.37|1.06|
91767614|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.17|||||TWO_SIDED|95.0|0.11|0.24||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2718). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.24|0.11|
91767615|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2722). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.99|0.72|
91553448|NCT04163991|182992779|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
91553449|NCT04163991|182992779|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
91553450|NCT04163991|182992779|SUPERIORITY||Hazard Ratio (HR)|3.01||||0.3407|TWO_SIDED|90.0|0.45|20.09||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||20.09|0.45|0.3407
91553451|NCT04163991|182992779|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
91553452|NCT02510235|182992822|NON_INFERIORITY|"To declare non-inferiority between treatments, a change in the SANDE overall score of 12 mm was required, with an estimated standard deviation of 13 (approximately 70% of the mean at 28 ± 4 days after treatment).~The left inferior limits of confidence interval were determined and compared with the non-inferiority limit defined in the testing hypothesis.~Testing Hypothesis:~H0: meanHyaluronic - meanLubricin ≤ - 12~/ H1: meanHyaluronic - meanLubricin \> - 12"|Mean Difference (Final Values)|1.5|||||ONE_SIDED|95.0|-8.87||||Student t-test for unpaired data.|||Values at Day 28 ± 4 (end of treatment) for the SANDE overall VAS score were compared between treatment groups using a Student's t-test for unpaired data.|||-8.87|
91553453|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.8226|TWO_SIDED|95.0|-7.66|6.11|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score||Foreign Body Sensation in the Study Eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||6.11|-7.66|0.8226
91553454|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.3178|TWO_SIDED|95.0|-3.13|9.44|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Burning/Stinging in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||9.44|-3.13|0.3178
91553455|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|6.52||||0.0085|TWO_SIDED|95.0|1.74|11.3|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Itching in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||11.30|1.74|0.0085
91553456|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|3.41||||0.3124|TWO_SIDED|95.0|-3.31|10.13|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Pain in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.13|-3.31|0.3124
91553457|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.0377|TWO_SIDED|95.0|0.4|13.12|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Sticky feeling in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||13.12|0.40|0.0377
91553458|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.5321|TWO_SIDED|95.0|-4.62|8.83|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Blurred vision in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||8.83|-4.62|0.5321
91553459|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|2.32||||0.579|TWO_SIDED|95.0|-6.04|10.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Photophobia in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.68|-6.04|0.5790
91553460|NCT02510235|182992824|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.3383|TWO_SIDED|95.0|-17.41|49.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Total ocular tolerability score in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||49.68|-17.41|0.3383
91553461|NCT02510235|182992825|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.6484|TWO_SIDED|95.0|-5.07|3.19|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||3.19|-5.07|0.6484
91553462|NCT02510235|182992826|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7408|TWO_SIDED|95.0|-0.71|0.51|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.51|-0.71|0.7408
91553463|NCT02510235|182992827|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.8596|TWO_SIDED|95.0|-0.78|0.87|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.87|-0.78|0.8596
91553464|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.7891|TWO_SIDED|95.0|-0.16|0.2|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Meibomian glands in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.20|-0.16|0.7891
91553465|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6075|TWO_SIDED|95.0|-0.24|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Erythema in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.24|0.6075
91767616|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.1|||||TWO_SIDED|95.0|0.06|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.15|0.06|
91767617|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.47||||||95.0|0.38|0.58||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.58|0.38|
91767618|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2786). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
91553466|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.6639|TWO_SIDED|95.0|-0.14|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.14|0.6639
91553467|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3482|TWO_SIDED|95.0|-0.1|0.29|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Erythema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value is not duplicated or triplicated, reflecting the global outcome consistent with repeated measures ANOVA methodology.||0.29|-0.10|0.3482
91553468|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.2422|TWO_SIDED|95.0|-0.34|0.09|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.09|-0.34|0.2422
91553469|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8645|TWO_SIDED|95.0|-0.11|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Lens in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.11|0.8645
91553470|NCT02510235|182992828|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.379|TWO_SIDED|95.0|-0.11|0.04|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Cornea transparency in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.04|-0.11|0.3790
91553471|NCT02510235|182992829|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8363|TWO_SIDED|95.0|-0.26|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.26|0.8363
91553472|NCT02510235|182992830|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.6248|TWO_SIDED|95.0|-0.62|1.02|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||1.02|-0.62|0.6248
91553473|NCT02510235|182992831|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.6153|TWO_SIDED|95.0|-0.82|0.49|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.49|-0.82|0.6153
91553474|NCT00450216|182992832|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||<|0.0001|TWO_SIDED|95.0|4.4|15.3||CMH test stratified by use of low-dose aspirin (yes/no) and prior upper gastrointestinal (UGI) ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The primary efficacy endpoint was the number of participants developing gastric ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 24 weeks. The cumulative number of participants developing gastric ulcers at 24 weeks was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by use of low-dose aspirin and prior UGI ulcer history.||15.3|4.4|<0.0001
91553475|NCT00450216|182992833|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.8|||<|0.0001|TWO_SIDED|95.0|6.1|17.6||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing UGI (i.e., gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative number of participants developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history.||17.6|6.1|<0.0001
91553476|NCT00450216|182992834|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.0006|TWO_SIDED|95.0|1.0|6.8||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing duodenal ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative number of participants developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prio UGI ulcer history at randomization.||6.8|1.0|0.0006
91553477|NCT05541484|182992844|OTHER|Spearman's ρ given non-normal variable distributions|||||<|0.0001||||||Spearman's ρ given non-normal variable distributions|Wilcoxon (Mann-Whitney)|||||||< 0.0001
91553478|NCT04499521|182992870|OTHER||Median Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.27|0.5||||||Mean difference between Gauze and Gel ARM A Bladder D2cc||0.50|-0.27|
91553479|NCT04499521|182992870|OTHER||Median Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||Mean difference between Gauze and Gel ARM B Bladder D2cc||0.96|-0.94|
91553480|NCT04499521|182992870|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.54|0.16||||||Mean difference between Gauze and Gel ARM A Rectum D2cc||0.16|-0.54|
91553481|NCT04499521|182992870|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.67|0.29||||||Mean difference between Gauze and Gel ARM B Rectum D2cc||0.29|-0.67|
91553482|NCT02585323|182992876|SUPERIORITY||Adjusted difference in mean change|13.1||||0.05|TWO_SIDED|95.0|1.6|24.5|||ANCOVA|||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 13 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||24.5|1.6|0.05
91767619|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.48|||||TWO_SIDED|95.0|0.39|0.59||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2782). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.59|0.39|
91767620|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.18|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.18|
91767621|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.41|||||TWO_SIDED|95.0|0.33|0.51||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2784). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.51|0.33|
91767622|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.3|||||TWO_SIDED|95.0|0.23|0.39||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2806). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.39|0.23|
91767623|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.46||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2803). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.46|0.28|
91553483|NCT02585323|182992877|SUPERIORITY||Adjusted difference in mean change|-29.5||||0.05|TWO_SIDED|95.0|-75.8|16.7|||ANCOVA|||||16.7|-75.8|0.05
91553484|NCT02585323|182992878|SUPERIORITY||Adjusted difference in mean change|-1.4||||0.05|TWO_SIDED|95.0|-7.8|4.9|||ANCOVA|||||4.9|-7.8|0.05
91553485|NCT02585323|182992879|SUPERIORITY||Adjusted diff in mean change at T0-T1|2.5||||0.05|TWO_SIDED|95.0|-4.2|9.5|||ANCOVA|||||9.5|-4.2|0.05
91767624|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88||||||95.0|0.75|1.02||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2759). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.02|0.75|
91553486|NCT02585323|182992880|SUPERIORITY||Adjusted diff in mean change at T0-T1|-3.8||||0.05|TWO_SIDED|95.0|-14.9|7.2|||ANCOVA|||||7.2|-14.9|0.05
91553487|NCT02585323|182992881|SUPERIORITY||Adjusted diff in mean change at T0-T1|2.8||||0.05|TWO_SIDED|95.0|-3.3|8.8|||ANCOVA|||||8.8|-3.3|0.05
91553488|NCT02585323|182992882|SUPERIORITY||Adjusted diff in mean change at T0-T1|1.4||||0.05|TWO_SIDED|95.0|-5.0|7.9|||ANCOVA|||||7.9|-5.0|0.05
91553489|NCT02585323|182992883|SUPERIORITY||Adjusted diff in mean change at T0-T1|-0.4||||0.05|TWO_SIDED|95.0|-1.7|0.8|||ANCOVA|||||0.8|-1.7|0.05
91553490|NCT02585323|182992884|SUPERIORITY||Adjusted diff in mean change at T0-T1|-2.3||||0.05|TWO_SIDED|95.0|-6.6|1.9|||ANCOVA|||||1.9|-6.6|0.05
91553491|NCT02585323|182992885|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.7||||0.05|TWO_SIDED|95.0|0.2|1.2|||ANCOVA|||||1.2|0.2|0.05
91767625|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2773). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.93|0.67|
91553492|NCT02585323|182992886|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.7||||0.05|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||||1.1|0.2|0.05
91553493|NCT02585323|182992887|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.3||||0.05|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.05
91553494|NCT02585323|182992888|SUPERIORITY||Adjusted diff in mean change at T0-T1|-0.1||||0.05|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.05
91553495|NCT02585323|182992889|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.2||||0.05|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||||0.5|-0.1|0.05
91553496|NCT02585323|182992890|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.1||||0.05|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||||0.8|-0.6|0.05
91553497|NCT02585323|182992891|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.1||||0.05|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.05
91553498|NCT04734197|182992905|SUPERIORITY|||||||0.004||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||Exploratory Phase 2 Study; the sample size of approximately 280-350 subjects (between 40 and 50 subjects per each of the 7 treatment groups) was based on medical judgement.||||0.0040
91553499|NCT04734197|182992906|SUPERIORITY|||||||0.3111|||||||Fisher Exact|The threshold for statistical significance is p=0.05.||"Mixed Model for Repeated Measures (MMRM) analysis included fixed effects of baseline TBUT, age, treatment, visit, and treatment by visit interaction.~Least squares means (LSMs) of the absolute TBUT change from baseline and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.3111
91553500|NCT04734197|182992907|SUPERIORITY|||||||0.2027||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||"MMRM analysis included fixed effects of baseline Schirmer test score, age, treatment, visit, and treatment by visit interaction.~LSMs of the absolute change from baseline in Schirmer test score and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.2027
91553501|NCT04310423|182992920|OTHER|||||||0.036|||||||Mixed Models Analysis|||Treatment x Time interaction for alcohol cue-induced alcohol craving.||||0.036
91553502|NCT04310423|182992921|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Two-way Treatment x Time interaction||||>0.05
91553503|NCT04310423|182992922|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
91553504|NCT04310423|182992923|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
91553505|NCT04310423|182992924|OTHER||||||<|0.001|||||||ANCOVA|||Main effect of treatment on alcohol cue-elicited brain activation||||<0.001
91553506|NCT03364127|182992931|SUPERIORITY||Mean Difference (Net)|-0.12||||0.702|TWO_SIDED|95.0|-0.76|0.51|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.51|-.76|0.702
91553507|NCT03364127|182992932|SUPERIORITY||Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.58|0.79|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.79|-.58|0.77
91553508|NCT03364127|182992933|SUPERIORITY||Mean Difference (Net)|1.16||||0.436|TWO_SIDED|95.0|-1.76|4.09|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||4.09|-1.76|0.436
91553509|NCT03364127|182992934|SUPERIORITY||Hazard Ratio (HR)|2.72||||0.017|TWO_SIDED|95.0|1.13|6.54||Kaplan-Meier curves by treatment arm were examined to determine the rates of return to baseline over the 12-week follow-up period .|Log Rank|||Goal was to assess duration of effect among those who showed a response to the intervention (1.5 or greater decrease in PIN).||6.54|1.13|0.017
91553510|NCT02278211|182992935|OTHER||Hazard Ratio (HR)|1.25||||0.2|TWO_SIDED|95.0|0.89|1.76|||Log Rank|||||1.76|0.89|0.20
91553511|NCT02278211|182992936|OTHER||Hazard Ratio (HR)|2.43||||0.02|TWO_SIDED|95.0|1.15|5.12|||Log Rank|||||5.12|1.15|0.02
91553512|NCT00303459|182992990|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.2508|TWO_SIDED|97.31|0.582|1.187|||Log Rank|||||1.187|0.582|0.2508
91553513|NCT00303459|182992991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.963||||0.8385|TWO_SIDED|95.0|0.673|1.38|||Log Rank|||||1.380|0.673|0.8385
91553514|NCT00303459|182992992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|21.8||||0.0106|TWO_SIDED|95.0|5.9|37.8|||Wilcoxon (Mann-Whitney)|||||37.8|5.9|0.0106
91553515|NCT00303459|182992993|SUPERIORITY_OR_OTHER_LEGACY||Relative risk of improvement|0.98||||1|TWO_SIDED|95.0|0.6|1.61|||Fisher Exact|||||1.61|0.60|1.0000
91553516|NCT00303459|182992994|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.855||||0.4974|TWO_SIDED|95.0|0.544|1.344|||Log Rank|||||1.344|0.544|0.4974
91767626|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.11|||||TWO_SIDED|95.0|0.07|0.16||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2794). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.16|0.07|
91767627|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2802). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
91553517|NCT00303459|182992995|SUPERIORITY_OR_OTHER_LEGACY||Percentage change over placebo|-23.52||||0.0003|TWO_SIDED|95.0|-33.69|-11.79|||Repeated measures analysis|||||-11.79|-33.69|0.0003
91553518|NCT00303459|182992996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.9566|TWO_SIDED|95.0|-0.42|0.39|||Wilcoxon (Mann-Whitney)|||||0.39|-0.42|0.9566
91553519|NCT00303459|182992997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.02||||0.5571|TWO_SIDED|95.0|-0.036|0.076|||Wilcoxon (Mann-Whitney)|||||0.076|-0.036|0.5571
91553520|NCT00303459|182992998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.4086|TWO_SIDED|95.0|-3.7|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-3.7|0.4086
91553521|NCT02492711|182993031|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0334|TWO_SIDED|95.0|0.593|0.979|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.979|0.593|0.0334
91553522|NCT02492711|182993032|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6204|TWO_SIDED|95.0|0.774|1.165|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||1.165|0.774|0.6204
91553523|NCT02492711|182993034|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.556|0.87|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.870|0.556|0.0014
91553524|NCT01474122|182993037|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.194||||0.434|TWO_SIDED|95.0|0.766|1.861|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 3 mg and in placebo|||1.861|0.766|0.434
91553525|NCT01474122|182993037|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.208||||0.407|TWO_SIDED|95.0|0.773|1.886|||NB-2||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 10 mg and in placebo|||1.886|0.773|0.407
91553526|NCT01474122|182993038|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.831||||0.5668|TWO_SIDED|95.0|0.442|1.564|||Chi-squared|||||1.564|0.442|0.5668
91553527|NCT01474122|182993038|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.789||||0.4624|TWO_SIDED|95.0|0.42|1.484|||Chi-squared|||||1.484|0.420|0.4624
91553528|NCT01474122|182993039|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.216||||0.6117|TWO_SIDED|95.0|0.572|2.582|||Chi-squared|||||2.582|0.572|0.6117
91553529|NCT01474122|182993039|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.9047|TWO_SIDED|95.0|0.485|2.264|||Chi-squared|||||2.264|0.485|0.9047
91553530|NCT01474122|182993040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.347|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.347
91553531|NCT01474122|182993040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.165|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.165
91553532|NCT01474122|182993041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.339|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.339
91553533|NCT01474122|182993041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.312|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.312
91553534|NCT01474122|182993042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.319|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.319
91553535|NCT01474122|182993042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.221|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.221
91553536|NCT02163694|182993070|SUPERIORITY|||||||0.003|||||||Log-rank test|||PFS was compared between the treatment groups using the log-rank test, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive versus ER/PgR negative).||||0.003
91553537|NCT02163694|182993070|SUPERIORITY||Stratified Cox proportional hazards|0.728||||0.003|TWO_SIDED|95.0|0.59|0.9|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||0.900|0.590|0.003
91553538|NCT02163694|182993071|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.410
91553539|NCT02163694|182993071|SUPERIORITY||Stratified Cox proportional hazards|0.914||||0.41|TWO_SIDED|95.0|0.737|1.333|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||1.333|0.737|0.410
91553540|NCT02163694|182993072|SUPERIORITY|||||||0.202||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.202
91553541|NCT02163694|182993073|SUPERIORITY|||||||0.715||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.715
91553542|NCT02163694|182993074|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
91553543|NCT02163694|182993074|SUPERIORITY||Stratified Cox proportional hazards|0.737||||0.004|TWO_SIDED|95.0|0.597|0.908|||Stratified Cox proportional hazards|Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).||||0.908|0.597|0.004
91553544|NCT03884101|182993075|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5550121|TWO_SIDED|95.0|0.83|1.24|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.24|0.83|0.5550121
91553545|NCT03884101|182993076|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1792058|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.10|0.77|0.1792058
91553546|NCT03884101|182993077|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.02||||0.2459875|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.2459875
91553547|NCT03884101|182993077|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5875597|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.5875597
91553548|NCT03884101|182993078|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21552|TWO_SIDED|95.0|0.77|1.12|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.12|0.77|0.21552
91553549|NCT03884101|182993079|OTHER||Difference in Percentage|-4.2||||0.8569|TWO_SIDED|95.0|-11.9|3.5|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||3.5|-11.9|0.8569
91553550|NCT03884101|182993080|OTHER||Difference in Percentage|0.0||||0.4999|TWO_SIDED|95.0|-6.7|6.7|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||6.7|-6.7|0.4999
91553551|NCT03884101|182993081|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-3.77||||0.0302|TWO_SIDED|95.0|-7.17|-0.36|||cLDA model|||||-0.36|-7.17|0.0302
91553552|NCT03884101|182993082|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-2.29||||0.1355|TWO_SIDED|95.0|-5.31|0.72|||cLDA model|||||0.72|-5.31|0.1355
91553553|NCT05061017|182993087|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
91553554|NCT05061017|182993088|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
91553555|NCT00626795|182993143|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|4.56|||||TWO_SIDED|95.0|-1.59|10.71|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||10.71|-1.59|
91553556|NCT00626795|182993143|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|-3.35|||||TWO_SIDED|95.0|-10.28|3.57|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||3.57|-10.28|
91553557|NCT05412004|182993160|SUPERIORITY||LS Mean Change difference|-20.01|||<|0.001|TWO_SIDED|95.0|-25.82|-14.2|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-14.20|-25.82|<0.001
91553558|NCT05412004|182993160|SUPERIORITY||LS Mean Change difference|-23.77|||<|0.001|TWO_SIDED|95.0|-29.61|-17.93|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-17.93|-29.61|<0.001
91553559|NCT05412004|182993161|SUPERIORITY||LS Mean Change difference|-47.65|||<|0.001|TWO_SIDED|95.0|-65.76|-29.55|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-29.55|-65.76|<0.001
91553560|NCT05412004|182993161|SUPERIORITY||LS Mean Change difference|-56.21|||<|0.001|TWO_SIDED|95.0|-73.73|-38.7|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-38.70|-73.73|<0.001
91553561|NCT05412004|182993162|SUPERIORITY||Risk Difference (RD)|42.77|||<|0.001|TWO_SIDED|95.0|30.76|54.79|||Regression, Logistic|||||54.79|30.76|<0.001
91553562|NCT05412004|182993162|SUPERIORITY||Risk Difference (RD)|48.6|||<|0.001|TWO_SIDED|95.0|36.55|60.65|||Regression, Logistic|||||60.65|36.55|<0.001
91553563|NCT05412004|182993163|SUPERIORITY||Risk Difference (RD)|28.74|||<|0.001|TWO_SIDED|95.0|18.27|39.22|||Regression, Logistic|||||39.22|18.27|<.001
91553564|NCT05412004|182993163|SUPERIORITY||Risk Difference (RD)|33.22|||<|0.001|TWO_SIDED|95.0|22.12|44.31|||Regression, Logistic|||||44.31|22.12|<0.001
91553565|NCT05412004|182993164|SUPERIORITY||Median Difference (Net)|-70.13|STANDARD_ERROR_OF_MEAN|10.619|||TWO_SIDED|95.0|-90.94|-49.31||||||||-49.31|-90.94|
91553566|NCT05412004|182993164|SUPERIORITY||Median Difference (Net)|-61.29|STANDARD_ERROR_OF_MEAN|11.921|||TWO_SIDED|95.0|-84.66|-37.93||||||||-37.93|-84.66|
91553567|NCT05412004|182993165|SUPERIORITY||LS Mean Change difference|-2.03||||0.037|TWO_SIDED|95.0|-3.95|-0.12|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-0.12|-3.95|0.037
91553568|NCT05412004|182993165|SUPERIORITY||LS Mean Change difference|-3.43||||0.003|TWO_SIDED|95.0|-5.69|-1.17|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Related Impairment||-1.17|-5.69|0.003
91553569|NCT05412004|182993165|SUPERIORITY||LS Mean Change difference|-3.9|||<|0.001|TWO_SIDED|95.0|-6.21|-1.58|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-1.58|-6.21|<0.001
91553570|NCT05412004|182993165|SUPERIORITY||LS Mean Change difference|-4.26||||0.002|TWO_SIDED|95.0|-6.97|-1.56|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep-Related Impairment||-1.56|-6.97|0.002
91553571|NCT05412004|182993166|SUPERIORITY||LS Mean Change difference|-16.09|||<|0.001|TWO_SIDED|95.0|-17.99|-14.19|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-14.19|-17.99|<0.001
91553572|NCT05412004|182993166|SUPERIORITY||LS Mean Change difference|-17.28|||<|0.001|TWO_SIDED|95.0|-19.29|-15.28|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-15.28|-19.29|<.001
91553573|NCT05412004|182993167|SUPERIORITY||LS Mean Change difference|-0.71|STANDARD_ERROR_OF_MEAN|0.253||0.752|TWO_SIDED|95.0|-1.21|-0.22||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.22|-1.21|0.752
91553574|NCT05412004|182993167|SUPERIORITY||LS Mean Change difference|-1.04|STANDARD_ERROR_OF_MEAN|0.269||0.35|TWO_SIDED|95.0|-1.57|-0.51||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.51|-1.57|0.350
91553575|NCT05412004|182993168|SUPERIORITY||LS Mean Change difference|-7.62|||<|0.001|TWO_SIDED|95.0|-10.48|-4.77|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-4.77|-10.48|<0.001
91553576|NCT05412004|182993168|SUPERIORITY||LS Mean difference|-3.7||||0.017|TWO_SIDED|95.0|-6.75|-0.65|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-0.65|-6.75|0.017
91553577|NCT03781089|182993169|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
91553578|NCT03781089|182993170|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
91553579|NCT02246127|182993194|SUPERIORITY||Odds Ratio (OR)|0.65||||0.229|TWO_SIDED|95.0|0.32|1.32|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.32|0.32|0.229
91553580|NCT02246127|182993195|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.19|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.19|0.90|0.135
91553581|NCT02246127|182993196|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.474|TWO_SIDED|95.0|0.77|1.75|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.75|0.77|0.474
91553582|NCT02246127|182993198|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
91553583|NCT02246127|182993200|SUPERIORITY|||||||0.012|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.012
91553584|NCT02246127|182993201|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
91553585|NCT02246127|182993202|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.168|TWO_SIDED|95.0|0.86|2.37|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.37|0.86|0.168
91553586|NCT02246127|182993204|SUPERIORITY|||||||0.072|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.072
91553587|NCT02246127|182993206|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.079|TWO_SIDED|95.0|0.94|2.73|||Log Rank|||significant differences between both arms is assumed in case p-val \< 0.05||2.73|0.94|0.079
91553588|NCT03279978|182993315|OTHER||Slope|0.7124|STANDARD_ERROR_OF_MEAN|0.0694|||TWO_SIDED|95.0|0.5702|0.8546||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8546|0.5702|
91553589|NCT03279978|182993315|OTHER||Slope|0.5964|STANDARD_ERROR_OF_MEAN|0.0575|||TWO_SIDED|95.0|0.4777|0.7151||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7151|0.4777|
91767628|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2753). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.18|0.88|
91553590|NCT03279978|182993316|OTHER||Slope|0.6445|STANDARD_ERROR_OF_MEAN|0.0649|||TWO_SIDED|95.0|0.5124|0.7766||||||Dose proportionality for Cmax of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7766|0.5124|
91553591|NCT03279978|182993316|OTHER||Slope|0.6223|STANDARD_ERROR_OF_MEAN|0.0715|||TWO_SIDED|95.0|0.4747|0.7699||||||Dose proportionality for Cmax of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7699|0.4747|
91553592|NCT03279978|182993317|OTHER||Slope|0.6401|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|95.0|0.4545|0.8258||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8258|0.4545|
91553593|NCT03279978|182993317|OTHER||Slope|0.5811|STANDARD_ERROR_OF_MEAN|0.0864|||TWO_SIDED|95.0|0.4013|0.7609||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7609|0.4013|
91553594|NCT03279978|182993318|OTHER||Slope|0.6005|STANDARD_ERROR_OF_MEAN|0.0722|||TWO_SIDED|95.0|0.4534|0.7477||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7477|0.4534|
91553595|NCT03279978|182993318|OTHER||Slope|0.5799|STANDARD_ERROR_OF_MEAN|0.0656|||TWO_SIDED|95.0|0.4441|0.7156||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7156|0.4441|
91553596|NCT04159519|182993320|OTHER|Mixed model for repeated measure (MMRM) with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.|Least square mean difference|0.1062|||||TWO_SIDED|95.0|-0.0485|0.2609||||||Comparison with reference arm||0.2609|-0.0485|
91553597|NCT04159519|182993321|OTHER|Comparison|Least square mean difference|-0.0343|||||TWO_SIDED|95.0|-0.2527|0.1841|||Mixed model for repeated measure (MMRM)|MMRM with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.||Comparison with reference arm||0.1841|-0.2527|
91553598|NCT03493542|182993343|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.42|||<|0.0001|TWO_SIDED|95.0|1.28|1.58|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 6||1.58|1.28|<0.0001
91553599|NCT03493542|182993343|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.39|||<|0.0001|TWO_SIDED|95.0|1.25|1.55|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 11||1.55|1.25|<0.0001
91553600|NCT03493542|182993343|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.53|||<|0.0001|TWO_SIDED|95.0|1.37|1.7|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 16||1.70|1.37|<0.0001
91553601|NCT03493542|182993343|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.45|1.9|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 18||1.90|1.45|<0.0001
91553602|NCT03493542|182993364|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 6||1.2|-1.1|<0.0001
91553603|NCT03493542|182993364|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 11||1.2|-1.1|<0.0001
91767629|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.18|||||TWO_SIDED|95.0|1.03|1.34||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2756). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.34|1.03|
91767630|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.67|||||TWO_SIDED|95.0|1.48|1.87||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2666). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.87|1.48|
91553604|NCT03493542|182993364|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 16||1.2|-1.1|<0.0001
91553605|NCT03493542|182993364|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 18||1.2|-1.1|<0.0001
91553606|NCT01651000|182993373|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91553607|NCT01651000|182993374|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91553608|NCT01651000|182993375|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91553609|NCT03734029|182993377|SUPERIORITY||Cox Proportional Hazard|0.5085|||<|0.0001|TWO_SIDED|95.0|0.4012|0.6444||Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.|Log Rank|||||0.6444|0.4012|<0.0001
91553610|NCT03952520|182993418|SUPERIORITY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|26.5|48.1|||||This generalized linear model was adjusted for engagement of site leadership. The Standard Approach is the referent.|||48.1|26.5|
91553611|NCT03952520|182993419|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|2.0|2.1|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.1|2.0|
91553612|NCT03952520|182993421|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||0.4|-0.2|
91553613|NCT03952520|182993422|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.1|2.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.0|-3.1|
91553614|NCT03952520|182993423|SUPERIORITY||Prevalence Difference|15.8|||||TWO_SIDED|95.0|5.0|26.5|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||26.5|5.0|
91553615|NCT03952520|182993424|SUPERIORITY||Prevalence Difference|1.6|||||TWO_SIDED|95.0|-6.9|10.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||10.0|-6.9|
91553616|NCT03952520|182993426|SUPERIORITY||Prevalence Difference|6.2|||||TWO_SIDED|95.0|-1.5|13.8|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||13.8|-1.5|
91553617|NCT03635567|182993428|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.47|0.71||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (hazard ratio \[HR\]) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.71|0.47|<0.0001
91767631|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.8|||||TWO_SIDED|95.0|1.61|2.0||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2663). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.00|1.61|
91767632|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.61|||||TWO_SIDED|95.0|0.5|0.73||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2783). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.73|0.50|
91553618|NCT03635567|182993429|OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.50|<0.0001
91553619|NCT03635567|182993430|OTHER||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.68|0.40|<0.0001
91553620|NCT03635567|182993431|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
91553621|NCT03635567|182993432|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.77||No formal hypothesis testing performed; nominal p-value based on log-rank test provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.77|0.52|<0.0001
91767633|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.76|0.53|
91553622|NCT03635567|182993433|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.78||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.78|0.44|<0.0001
91553623|NCT03635567|182993434|OTHER||Difference in Percentage|14.9||||0.0001|TWO_SIDED|95.0|7.4|22.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Miettinen & Nurminen method|||Treatment comparison was based on Miettinen \& Nurminen method stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||22.3|7.4|0.0001
91553624|NCT03635567|182993437|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
91553625|NCT05157841|182993443|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Mean Difference (Final Values)|-164.0|STANDARD_ERROR_OF_MEAN|27.74|<|1e-05|TWO_SIDED|95.0|-218.3|-109.6|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||-109.6|-218.3|<0.00001
91553626|NCT05157841|182993444|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Least square mean difference|0.39|||<|1e-05|TWO_SIDED|95.0|0.28|0.55|||ANCOVA|||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||0.55|0.28|<0.00001
91553627|NCT05157841|182993445|SUPERIORITY||Odds Ratio (OR)|5.04||||0.0003|TWO_SIDED|95.0|2.01|12.62|||ANCOVA|||||12.62|2.01|0.0003
91767634|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.51|||||TWO_SIDED|95.0|0.42|0.62||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2772). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.62|0.42|
91553628|NCT05157841|182993446|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0089|TWO_SIDED|95.0|0.45|0.93|||Cox proportional hazards model|Cox proportional hazards model with treatment as main effect and site as categorical and age as continuous covariates.||||0.93|0.45|0.0089
91553629|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0296|TWO_SIDED|95.0|-1.7|0.0||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariate of age.||||0.0|-1.7|0.0296
91553630|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|1e-05|TWO_SIDED|95.0|-3.6|-2.1||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.1|-3.6|<0.00001
91553631|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.41|<|1e-05|TWO_SIDED|95.0|-4.1|-2.5||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.5|-4.1|<0.00001
91553632|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|1e-05|TWO_SIDED|95.0|-3.0|-1.3||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-3.0|<0.00001
91553633|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3419|TWO_SIDED|95.0|-0.9|0.6||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.6|-0.9|0.3419
91553634|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.5|-1.3||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-2.5|<0.00001
91553635|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.8|-1.6||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.6|-2.8|<0.00001
91553636|NCT05157841|182993447|SUPERIORITY||Least square mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.1|-0.9||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.9|-2.1|<0.00001
91553637|NCT04757753|182993449|NON_INFERIORITY|"πN = 2-year successful treatment rate of PA1704 πR = 2-year successful treatment rate of BioRoot™ RCS Δ = πN - πR ΔL = non-inferiority margin fixed to 13% or 0.13~Hypotheses are :~H0 : Δ ≤ -ΔL H1 : Δ \> -ΔL The χ2 of Dunnett \& Gent is used to assess the non-inferiority"|Mean Difference (Final Values)|0.006||||0.03|TWO_SIDED|90.0|-0.0074|0.0087||A priori threshold for statistical significance was \< 0.05|Chi-squared, Corrected|||The statistical analysis was done on the proportion difference of the treatment efficacy, defined on loose criteria, at 24 months, in PP population.||0.0087|-0.0074|0.03
91553638|NCT03370913|182993494|SUPERIORITY||% Reduction from Baseline|-77.0|||<|0.0001|TWO_SIDED|||||P-values were for 2-sided test against 0.|t-test, 2 sided|Superiority was tested by1-sample t-test to test null hypothesis that change is \>=0. Only negative changes represent efficacy.|77% reduction|Change from baseline in the ABR for all bleeds (post-baseline EEP value - baseline value)||||<0.0001
91767635|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.65||||||95.0|0.55|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2768). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.55|
91767636|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.31|||||TWO_SIDED|95.0|0.24|0.4||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2814). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.40|0.24|
91767637|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.45||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2797). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.45|0.28|
91767638|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.62|||||TWO_SIDED|95.0|0.51|0.74||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.74|0.51|
91553639|NCT03816397|182993502|SUPERIORITY|A sample size of 118 subjects (59 in each group) provides 88% power to detect a hazard ratio of 2.0 for the time to treatment failure comparing the group randomized to discontinue adalimumab to the group randomized to continue using adalimumab, assuming a median time until treatment failure of 10 weeks in the group that discontinues adalimumab (Arm 1) and of 20 weeks in the group that continues on adalimumab (Arm 2), an equal allocation between groups, and a 10% total loss to follow-up.|Hazard Ratio (HR)|8.7|||<|0.0001|TWO_SIDED|95.0|3.6|21.2||A priori threshold for statistical significance was \<0.05.|Log Rank||For the HR, the numerator is the placebo group (stop adalimumab) and the denominator is the adalimumab group (continue adalimumab).|A Cox proportional hazards regression was used to compare time to treatment failure between the adalimumab and placebo groups up to the primary endpoint of 48 weeks, with country and conventional DMARD use included as fixed effects in the model. The null hypothesis was an hazard ratio (HR) of 1. Hypothesis testing was based on a permutation test of the log hazard ratio (100,000 replicates). The model was checked for the assumption of proportional hazards by assessing Schoenfeld residuals.||21.2|3.6|<0.0001
91553640|NCT04496752|182993519|EQUIVALENCE|Weighted Cohen's kappa statistics were computed between DCTClock-pen and MMSE, and between DCTClock-tablet and MMSE. A TOST (two one-sided test) of equivalence was planned, with a difference in kappa of 0.2 specified a priori as significant.|Difference in Cohen's Kappa|0.07|||||TWO_SIDED|90.0|-0.05|0.19|||||The difference is Cohen's kappa is (tablet - pen). The confidence interval is estimated with a nonparametric bootstrap (5000 samples).|||0.19|-0.05|
91553641|NCT04679389|182993599|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91553642|NCT04679389|182993600|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
91553643|NCT04679389|182993601|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
91553644|NCT04679389|182993602|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91553645|NCT04679389|182993605|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
91553646|NCT04679389|182993606|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91553647|NCT05257603|182993607|OTHER||Mean Difference (Net)|4.82|STANDARD_ERROR_OF_MEAN|0.615|<|0.99|TWO_SIDED|95.0|3.24|5.72|||ANOVA|||||5.72|3.24|<0.99
91553648|NCT05257603|182993608|OTHER||||||<|0.29|||||||Chi-squared|||||||<.29
91553649|NCT05257603|182993609|OTHER||||||<|0.99|||||||ANOVA|||A one-way ANOVA was used to compare the mean difference in key presses from time 1 to time 2 between the intervention (RPCW) and Control conditions.||||<0.99
91553650|NCT05257603|182993610|OTHER||||||<|0.45|||||||ANOVA|||||||<0.45
91553651|NCT05257603|182993611|OTHER||||||<|0.1||||||Given the exploratory nature of the analysis we were looking for a trend in improvement in emotion regulation (i.e., p\<.10) following the intervention condition compared to control.|ANOVA|||||||<.10
91553652|NCT05257603|182993612|OTHER||||||<|0.1|||||||ANOVA|||Repeated measure ANOVA was used to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
91553653|NCT05257603|182993613|OTHER||||||<|0.1||||||A priori threshold for a trend set at p\<.10 for condition effect (intervention v control).|ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
91553654|NCT05257603|182993614|OTHER||||||<|0.098|||||||ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial.||||<.098
91553655|NCT02777593|182993615|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.64, then the the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.751|||||ONE_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.~Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required."||||
91553656|NCT05954546|182993616|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.62|1.72|||||Hazard ratio (HR) was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Encorafenib+Binimetinib (RWD) relative to Encorafenib+Binimetinib (CTD) (reference).||1.72|0.62|
91553657|NCT04780581|182993629|EQUIVALENCE|log-rank statistic test.|Odds Ratio (OR)|1.0||||0.984|TWO_SIDED|95.0|0.2|5.1|||Log Rank|||Null hypothesis of equal survival curves. Estimates of rate and risk ratios are shown with 95% confidence intervals. All the p-values are 2-sided and shown without adjustment for multiple testing, and p \< 0.05 was considered statistically significant. The analyses were performed using IBM SPSS Statistics for Windows, Version 26.0 (Armonk, NY, USA: IBM Corp.).||5.1|0.2|0.984
91553658|NCT04780581|182993629|EQUIVALENCE|Log-rank method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-8.8|9.1||||||||9.1|-8.8|
91553659|NCT04780581|182993630|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.833|TWO_SIDED|95.0|0.4|3.0|||Chi-squared|||||3.0|0.4|0.833
91553660|NCT04780581|182993630|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-14.2|11.5||||||||11.5|-14.2|
91553661|NCT04780581|182993631|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.5||||0.661|TWO_SIDED|95.0|0.2|9.3|||Chi-squared|||non-invasive mechanical ventilation||9.3|0.2|0.661
91553662|NCT04780581|182993631|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-10.2|6.9||||||non-invasive mechanical ventilation||6.9|-10.2|
91553663|NCT04780581|182993631|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.7||||0.549|TWO_SIDED|95.0|0.2|2.2|||Chi-squared|||high-flow oxygen requirements||2.2|0.2|0.549
91553664|NCT04780581|182993631|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-8.2|15.1||||||high-flow oxygen requirements||15.1|-8.2|
91553665|NCT04780581|182993631|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.809|TWO_SIDED|95.0|0.4|3.3|||Chi-squared|||Invasive mechanical ventilation or intubation requirements analysis||3.3|0.4|0.809
91553666|NCT04780581|182993631|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-13.0|11.1||||||Invasive mechanical ventilation or intubation requirements analysis||11.1|-13.0|
91553667|NCT04780581|182993632|EQUIVALENCE|T-test|Risk Difference (RD)|-0.3||||0.908|TWO_SIDED|95.0|-5.0|5.0|||t-test, 1 sided|||||5|-5|0.908
91553668|NCT04780581|182993633|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.8||||0.758|TWO_SIDED|95.0|0.3|2.5|||Chi-squared|||Secondary infections||2.5|0.3|0.758
91553669|NCT04780581|182993633|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-10.1|13.7||||||Secondary infections||13.7|-10.1|
91553670|NCT04780581|182993633|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|4.2||||0.007|TWO_SIDED|95.0|1.4|12.3|||Chi-squared|||Hyperglycaemia||12.3|1.4|0.007
91553671|NCT04780581|182993633|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-18.9|||||TWO_SIDED|95.0|-31.8|-5.6||||||Hyperglycaemia||-5.6|-31.8|
91553672|NCT04780581|182993633|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.6||||0.319|TWO_SIDED|95.0|-8.5|4.4|||Chi-squared|||Psychotic states||4.4|-8.5|0.319
91553673|NCT04780581|182993634|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.0||||0.962|TWO_SIDED|95.0|0.4|2.3|||Chi-squared|||||2.3|0.4|0.962
91553674|NCT04780581|182993634|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-14.2|14.9||||||||14.9|-14.2|
91553675|NCT02765412|182993642|OTHER|multilevel model|Odds Ratio (OR)|0.67||||0.081|TWO_SIDED|95.0|0.58|0.78||Two-sided test; the a priori threshold being 0.05|Regression, Logistic|Adjusts for age, gender, race, comorbidities, implementation group, travel distance, and VAMC indicator|OR corresponding to the interaction between implementation group and lung cancer risk, a ratio of odds ratios. The OR for screening based on lung cancer risk in the SI group versus the OR for screening based on lung cancer risk in the II group|||0.78|0.58|0.081
91553676|NCT02765412|182993643|OTHER||Median Difference (Net)|-0.15||||0.35|TWO_SIDED|95.0|-0.16|0.46||Two-sided test; the a priori threshold being 0.05|t-test, 2 sided||Satisfaction rating on a scale of 0 to 10; Difference is Arm 1 - Arm 2|Simple t-test comparing mean satisfaction ratings between arms||0.46|-0.16|0.35
91553677|NCT03990883|182993647|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.37|||<|0.0001|TWO_SIDED|95.0|-2.96|3.7|||McNemar|||||3.7|-2.96|<0.0001
91553678|NCT03990883|182993648|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.0|||<|0.0001|TWO_SIDED|95.0|-3.71|3.71||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.71|-3.71|<0.0001
91553679|NCT03990883|182993649|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-2.96||||0.025|TWO_SIDED|95.0|-9.99|4.07||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||4.07|-9.99|0.025
91553680|NCT03990883|182993650|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45||||0.009|TWO_SIDED|95.0|-8.42|7.52||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||7.52|-8.42|0.009
91553681|NCT03990883|182993651|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.37|||<|0.0001|TWO_SIDED|95.0|-3.85|3.11||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.11|-3.85|<0.0001
91767639|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2763). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.54|
91767640|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.56||||||95.0|0.46|0.68||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2775). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.68|0.46|
91553682|NCT03990883|182993652|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45|||<|0.0001|TWO_SIDED|95.0|-4.05|3.16||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.16|-4.05|<0.0001
91553683|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.8842|TWO_SIDED|95.0|-7.0|8.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||8|-7|0.8842
91553684|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|18.0|||<|0.0001|TWO_SIDED|95.0|10.0|27.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||27|10|<0.0001
91553685|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|47.0|||<|0.0001||95.0|38.0|56.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||56|38|<0.0001
91553686|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|58.0|||<|0.0001|TWO_SIDED|95.0|46.0|70.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||70|46|<0.0001
91553687|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|59.0|||<|0.0001|TWO_SIDED|95.0|47.0|72.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||72|47|<0.0001
91553688|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|80.0|||<|0.0001|TWO_SIDED|95.0|71.0|89.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||89|71|<0.0001
91553689|NCT00624442|182993723|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)"||||<0.0001
91553690|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.3665|TWO_SIDED|95.0|-1.0|2.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||2|-1|0.3665
91553691|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0|||<|0.0357|TWO_SIDED|95.0|0.0|3.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||3|0|<0.0357
91553692|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0004|TWO_SIDED|95.0|1.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|1|0.0004
91553693|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0086|TWO_SIDED|95.0|1.0|4.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||4|1|0.0086
91553694|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|2.0||||0.032|TWO_SIDED|95.0|0.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|0|0.032
91553695|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|5.0|||<|0.0001|TWO_SIDED|95.0|3.0|6.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||6|3|<0.0001
91553696|NCT00624442|182993724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)"||||<0.0001
91553697|NCT04933474|182993727|OTHER|||||||0.088|||||||Chi-squared|||The primary outcome will be the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dichotomized into if the MCID of 2 is achieved. The between arm difference of achieving the MCID of 2 will be tested using Chi-squared test.||||0.088
91553698|NCT04933474|182993728|OTHER|||||||0.103|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.103
91553699|NCT04933474|182993729|OTHER|||||||0.774|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.774
91767641|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2785). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.71|0.49|
91767642|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.5|||||TWO_SIDED|95.0|0.41|0.61||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.61|0.41|
91767643|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.97|||||TWO_SIDED|95.0|0.84|1.12||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2824). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.12|0.84|
91767644|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.75|||||TWO_SIDED|95.0|0.63|0.88||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.88|0.63|
91553700|NCT04933474|182993730|OTHER|||||||0.005|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.005
91553701|NCT04933474|182993731|OTHER|||||||0.831|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.831
91553702|NCT04933474|182993732|OTHER||Common Odds Ratio|1.44||||0.031|TWO_SIDED|95.0|1.03|2.02||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and week 8) and opioid use (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||2.02|1.03|0.031
91553703|NCT04243759|182993768|SUPERIORITY|||||||0.97|||||||ANOVA|||||||0.97
91553704|NCT04243759|182993769|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_DEVIATION|2.09||0.232|TWO_SIDED|95.0|-0.24|0.95|||t-test, 2 sided|||Within subjects comparison of drinks per drinking day with full intervention app access versus daily assessment via the app only||0.95|-0.24|.232
91553705|NCT04868656|182993770|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.15|TWO_SIDED|95.0|-5.0|0.8|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||0.8|-5.0|0.15
91553706|NCT04868656|182993771|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.34|TWO_SIDED|95.0|-6.0|16.6|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||16.6|-6.0|0.34
91553707|NCT04868656|182993772|SUPERIORITY||Odds Ratio (OR)|0.6||||0.23|TWO_SIDED|95.0|0.1|2.5|||Regression, Logistic|||Model includes the arm indicator variable only; model does not include stratification variables due to potential for overfitting.||2.5|0.1|0.23
91553708|NCT06603766|182993824|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
91553709|NCT06603766|182993825|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
91553710|NCT06603766|182993826|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
91553711|NCT06603766|182993827|SUPERIORITY|||||||0.032|||||||Chi-squared|||||||0.032
91553712|NCT06603766|182993828|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91553713|NCT06603766|182993829|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91553714|NCT05785130|182993836|SUPERIORITY|T0|Mean Difference (Final Values)|-25.07||||0.74|TWO_SIDED|||||T0|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.74
91553715|NCT05785130|182993836|SUPERIORITY||Median Difference (Final Values)|133.57||||0.75|TWO_SIDED|||||T1|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.75
91553716|NCT05785130|182993836|SUPERIORITY|T|Median Difference (Final Values)|235.93|||<|0.01|TWO_SIDED|||||T2|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
91553717|NCT05785130|182993836|SUPERIORITY|T3|Median Difference (Final Values)|214.18|||<|0.01|TWO_SIDED|||||T3|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
91553718|NCT02624050|182993840|SUPERIORITY||Risk Ratio (RR)|1.0||||0.01|TWO_SIDED|||||Threshold for significance was p\<0.05.|log-binomial regression|||||||0.01
91553719|NCT02624050|182993841|SUPERIORITY||Risk Ratio (RR)|1.0||||0.37|TWO_SIDED|||||Threshold of significance was \<0.05|log binomial regression|||||||0.37
91553720|NCT02624050|182993846|SUPERIORITY|||||||0.277||||||"Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.~Threshold for statistical significance was \<0.05"|Ratio of Geometric Means|This p-value is for 15 min after induction of anesthesia||||||0.277
91553721|NCT03547271|182993851|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>1/1.5 for all 4 serogroups.|GMT ratio|0.69|||||TWO_SIDED|95.0|0.565|0.842|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup A||0.842|0.565|
91553722|NCT03547271|182993851|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|4.73|||||TWO_SIDED|95.0|4.0|5.58|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup C||5.58|4.00|
91553723|NCT03547271|182993851|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|Slope|1.54|||||TWO_SIDED|95.0|1.33|1.78|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup W||1.78|1.33|
91553724|NCT03547271|182993851|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|1.78|||||TWO_SIDED|95.0|1.55|2.04|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup Y||2.04|1.55|
91553725|NCT03547271|182993852|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|-12.2|||||TWO_SIDED|95.0|-17.74|-6.56|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup A||-6.56|-17.74|
91553726|NCT03547271|182993852|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|6.89|||||TWO_SIDED|95.0|4.44|9.62|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup C||9.62|4.44|
91553727|NCT03547271|182993852|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|2.07|||||TWO_SIDED|95.0|-0.49|4.7|||||95% CI of the difference was calculated from the Wilson score method without continuity correction|Statistical analysis for Serogroup W||4.70|-0.49|
91553728|NCT03547271|182993852|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|3.01|||||TWO_SIDED|95.0|0.34|5.77|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup Y||5.77|0.34|
91553729|NCT04835363|182993869|SUPERIORITY|||||||0.029|||||||ANOVA|||||||0.029
91553730|NCT04835363|182993870|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
91553731|NCT04835363|182993871|SUPERIORITY|||||||0.012|||||||ANOVA|||||||0.012
91553732|NCT04835363|182993872|SUPERIORITY|||||||0.078|||||||ANOVA|||||||0.078
91553733|NCT04835363|182993873|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
91553734|NCT04835363|182993874|SUPERIORITY|||||||0.797|||||||ANOVA|||||||0.797
91553735|NCT04835363|182993875|SUPERIORITY|||||||0.358|||||||ANOVA|||||||0.358
91553736|NCT04835363|182993876|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
91553737|NCT04835363|182993877|SUPERIORITY|||||||0.496|||||||ANOVA|||||||0.496
91553738|NCT04835363|182993878|SUPERIORITY|||||||0.241|||||||ANOVA|||||||0.241
91553739|NCT04835363|182993879|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
91767645|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|2.11|||||TWO_SIDED|95.0|1.91|2.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.33|1.91|
91767646|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.13|||||TWO_SIDED|95.0|4.79|5.49||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.49|4.79|
91553740|NCT04835363|182993880|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
91553741|NCT04835363|182993881|SUPERIORITY|||||||0.141|||||||ANOVA|||ENGAGEMENT STRATEGIES||||0.141
91553742|NCT04835363|182993881|SUPERIORITY|||||||0.496|||||||ANOVA|||DISENGAGEMENT STRATEGIES||||0.496
91553743|NCT03904576|182993882|OTHER||Difference of least squares means (T-R)|-7.305|STANDARD_ERROR_OF_MEAN|2.082|||TWO_SIDED|90.0|-10.949|-3.661||||||Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||-3.661|-10.949|
91553744|NCT03904576|182993882|OTHER||Difference in %|-24.396|||||||||||||Difference of least squares means in % (ratio to Placebo) (T-R)/R\*100%|Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||||
91553745|NCT01992913|182993884|SUPERIORITY||||||<|0.05||||||"Fisher's exact Test, right-sided probability based on a directional hypothesis."|Fisher Exact|||We conducted a 2 X 2 chi-square analysis of differences in proportion.||||<.05
91553746|NCT01992913|182993884|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.06|TWO_SIDED|95.0|0.97|7.13|||Chi-squared|ChiSq = 3.6562, df = 1|OR, iCBT / TAU in job attainment|Chis Sq: group (iCBT/TAU) X Job attained (Yes/No)||7.13|0.97|<.06
91553747|NCT01992913|182993885|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.91|<|0.33|TWO_SIDED|95.0|-2.67|0.89|||Mixed Models Analysis|df (1, 30) for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 6 month assessment points.||.89|-2.67|<0.33
91553748|NCT01992913|182993885|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.52|STANDARD_ERROR_OF_MEAN|0.85|<|0.54|TWO_SIDED|95.0|-1.14|2.19|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 12 month assessment points.||2.19|-1.14|<.54
91553749|NCT01992913|182993885|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.83|<|0.71|TWO_SIDED|95.0|-1.32|1.73|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 18 month assessment point.||1.73|-1.32|<0.71
91553750|NCT01992913|182993887|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-5.03|STANDARD_ERROR_OF_MEAN|3.82|<|0.19|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.19
91553751|NCT01992913|182993887|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 6 month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|4.42|<|0.99|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.99
91553752|NCT01992913|182993887|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 12 month assessment.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|4.54|<|0.94|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.94
91553753|NCT01992913|182993887|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|4.52|<|0.14|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.14
91553754|NCT04881110|182993888|SUPERIORITY||Mean Difference (Final Values)|11.2|||<|0.001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|14.5|8.0|<0.001
91553755|NCT04881110|182993888|SUPERIORITY||Risk Ratio (RR)|1.91|||<|0.001|TWO_SIDED|95.0|1.26|2.9|||Chi-squared||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.90|1.26|<0.001
91553756|NCT04881110|182993889|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.06|TWO_SIDED|95.0|-0.8|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.8|0.06
91553757|NCT04881110|182993890|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.52|TWO_SIDED|95.0|-14.3|7.4|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|7.4|-14.3|0.52
91553758|NCT04881110|182993891|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.33|TWO_SIDED|95.0|-3.6|1.2|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|1.2|-3.6|0.33
91553759|NCT04881110|182993892|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.1|TWO_SIDED|95.0|-1.7|0.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.1|-1.7|0.10
91553760|NCT04881110|182993893|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.8|3.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|3.5|-2.8|0.81
91553761|NCT04881110|182993894|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-5.8|5.8|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|5.8|-5.8|0.99
91553762|NCT04881110|182993895|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.72|TWO_SIDED|95.0|-32.6|22.9|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|22.9|-32.6|0.72
91767647|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.72|||||TWO_SIDED|95.0|5.36|6.1||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.10|5.36|
91553763|NCT04881110|182993896|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-0.7|-0.07|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|-0.07|-0.7|0.02
91553764|NCT04881110|182993897|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.12|TWO_SIDED|95.0|-0.04|0.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.3|-0.04|0.12
91553765|NCT04881110|182993898|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.25|TWO_SIDED|95.0|-8.5|2.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.3|-8.5|0.25
91553766|NCT04881110|182993899|SUPERIORITY||Mean Difference (Final Values)|87.4|||<|0.001|TWO_SIDED|95.0|59.9|115.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|115.1|59.9|<0.001
91767648|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.29|||||TWO_SIDED|95.0|4.94|5.65||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.65|4.94|
91767649|NCT03629886|183424328|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|6.29|||||TWO_SIDED|95.0|5.91|6.69||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.69|5.91|
91553767|NCT04881110|182993900|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.18|TWO_SIDED|95.0|-0.09|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.09|0.18
91553768|NCT04881110|182993901|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.06|TWO_SIDED|95.0|-0.6|18.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|18.1|-0.6|0.06
91553769|NCT04881110|182993902|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.06|TWO_SIDED|95.0|-0.09|2.6|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.6|-0.09|0.06
91553770|NCT04881110|182993904|SUPERIORITY||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|21.8|28.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|28.3|21.8|<0.001
91553771|NCT05215054|182993905|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.||||||||||||||||Difference of changes from baseline in WSRS score for Gana V versus Sculptra|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.To assess assay sensitivity, the proportion of responders with Gana V®, defined as improvement of ≥1-grade in the WSRS when compared to D0 pre-injection must be ≥50% at the 6 months visit after baseline.|||
91553772|NCT02933489|182993917|EQUIVALENCE|H0: DBT = AB-MR|Wald interval with Bonett-Price Laplace|0.007||||0.002|TWO_SIDED|95.0|0.0022|0.0116|||McNemar||"Wald interval with Bonett-Price Laplace, described in :~Fagerland MW, Lydersen S, Laake P. Recommended tests and confidence intervals for paired binomial proportions. Statist. Med. 2014; 33:2850-75."|The proportion of participants who had an invasive cancer, verified by pathology, detected by each modality (the invasive cancer detection rates) will be made using exact McNemar's test.||0.0116|0.0022|0.002
91553773|NCT02933489|182993918|EQUIVALENCE|PPV DBT = PPV AB-MR||||||0.15||||||"Generalized estimating equation (GEE) regression with the p-value from the resulting score test.~5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance"|Leisenring|Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351||Positive Predictive Value (PPV)||||0.15
91553774|NCT02933489|182993919|EQUIVALENCE|H0: DBT short term follow-up rate = AB-MR short term follow-up rate|||||<|0.0001||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5=0.01 corresponding to the 5 secondary comparisons outlined in the Statistical Analysis Plan (SAP)|McNemar|exact p-value||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR short term follow-up rates||||<0.0001
91553775|NCT02933489|182993919|EQUIVALENCE|H0: DBT additional imaging rate =AB-MR additional imaging rate||||||0.02||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5 = 0.01, corresponding to the 5 secondary comparisons outlined in the SAP|McNemar|exact p-values||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR additional imaging rates||||0.02
91553776|NCT02933489|182993920|EQUIVALENCE|Sensitivity DBT = Sensitivity AB-MR||||||0.001||||||The comparison of the sensitivity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||0.001
91553777|NCT02933489|182993920|EQUIVALENCE|Specificity DBT = Specificity AB-MR|||||<|0.001||||||The comparison of the Specificity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||<0.001
91553778|NCT02720068|182993964|OTHER|Difference in Percentage|Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|22.9|||||Confidence interval based on Miettinen \& Nurminen method|||22.9|-7.3|
91553779|NCT04664881|182993993|SUPERIORITY|||||||0.71|||||||Chi-squared, Corrected|||||||0.71
91553780|NCT04664881|182993994|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiovascular Death||||0.99
91553781|NCT04664881|182993994|SUPERIORITY|||||||0.36|||||||Chi-squared, Corrected|||Hospitalization for Myocardial Infarction||||0.36
91553782|NCT04664881|182993994|SUPERIORITY|||||||0.13|||||||Chi-squared, Corrected|||Arrhythmias||||0.13
91553783|NCT04664881|182993994|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiac Arrest||||0.99
91553784|NCT05275556|182994042|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.0002|TWO_SIDED|95.0|0.07|0.23||Threshold for significance is 0.025.|Poisson Regression|||||0.23|0.07|0.0002
91553785|NCT05275556|182994043|NON_INFERIORITY|Non-inferiority margin is -10%.|Mean Difference (Final Values)|-0.06||||0.09|TWO_SIDED|95.0|-0.15|0.03||Threshold for significance is 0.025.|Resampling based|||||0.03|-0.15|0.09
91553786|NCT05275556|182994044|SUPERIORITY||Difference in percentage|5.5||||0.031|TWO_SIDED|95.0|-0.3|11.2|||Cochran-Mantel-Haenszel|Threshold for significance is 0.025.||||11.2|-0.3|0.031
91553787|NCT05275556|182994045|OTHER||rate|0.58|||||TWO_SIDED|||||||||||||
91553788|NCT05275556|182994046|OTHER|2 sided test for differences between arms|Mean Difference (Final Values)|0.58||||0.169|TWO_SIDED||||||Permutation test|||||||0.169
91553789|NCT05275556|182994047|OTHER||||||||||||||||||Descriptive analysis: 52.4 in Colonoscopy (Standard of Care), 59.6 in CAD-e Device|||
91553790|NCT05275556|182994048|SUPERIORITY||Mean Difference (Net)|4.6||||0.0578|TWO_SIDED|95.0|-0.2|9.4||Nominal p-value.|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.4|-0.2|0.0578
91553791|NCT05275556|182994049|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.7813|TWO_SIDED|95.0|-1.5|2.0||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.0|-1.5|0.7813
91553792|NCT05275556|182994050|SUPERIORITY||Least-squares means|0.11|||||TWO_SIDED|95.0|0.05|0.17||||||||0.17|0.05|
91553793|NCT05275556|182994051|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0004|TWO_SIDED|95.0|3.7|12.9||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||12.9|3.7|0.0004
91553794|NCT05275556|182994052|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1185|TWO_SIDED|95.0|-1.0|9.1||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.1|-1|0.1185
91553795|NCT05275556|182994053|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.0752|TWO_SIDED|95.0|-0.4|9.2||nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.2|-0.4|0.0752
91553796|NCT05275556|182994055|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.8194|TWO_SIDED|95.0|-3.2|2.6||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.6|-3.2|0.8194
91553797|NCT05275556|182994056|OTHER|Test for difference|Incidence Rate Ratio|1.39||||0.0008|TWO_SIDED|95.0|1.14|1.69||Nominal p-value|Exact poisson|||||1.69|1.14|0.0008
91553798|NCT03351998|182994095|SUPERIORITY||Mean Difference (Net)|36.02|STANDARD_DEVIATION|365.55||0.6051|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.6051
91553799|NCT03351998|182994095|SUPERIORITY||Mean Difference (Net)|31.89|STANDARD_DEVIATION|213.0||0.9434|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.9434
91553800|NCT03351998|182994095|SUPERIORITY||Mean Difference (Net)|-3.39|STANDARD_DEVIATION|179.54||0.9408|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.9408
91553801|NCT03351998|182994096|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.23||0.7458|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.7458
91553802|NCT03351998|182994096|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.16||0.4056|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.4056
91553803|NCT03351998|182994096|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.18||0.1932|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.1932
91553804|NCT05485935|182994247|SUPERIORITY||Mean Difference (Final Values)|45.94||||0.001|TWO_SIDED|95.0|19.24|72.64||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||72.64|19.24|0.001
91553805|NCT05485935|182994248|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.07|0.35|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.35|0.07|<0.001
91553806|NCT05485935|182994249|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.13|||<|0.001|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.40|0.04|<0.001
91553807|NCT05485935|182994250|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mean Difference (Final Values)|28.5||||0.004|TWO_SIDED|95.0|9.5|47.6|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||47.6|9.5|0.004
91553808|NCT04093869|182994253|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|5.1||0.4|TWO_SIDED|95.0|-6.0|14.0||Not adjusted for multiple comparisons. Full alpha of 0.05 was allocated to this as the sole primary outcome.|Regression, Linear||A negative mean difference would represent a better outcome in the CSTEX arm compared to the SOC-ED arm.|||14|-6|0.40
91553809|NCT04093869|182994254|SUPERIORITY||Mean Difference (Net)|20.7|STANDARD_ERROR_OF_MEAN|32.6|||TWO_SIDED|95.0|-44.0|85.0|||||A positive value for the estimate represents a greater distance walked for the CSTEX arm compared to the SOC-ED arm.|||85|-44|
91553810|NCT04093869|182994255|SUPERIORITY||Median Difference (Net)|-316.0|STANDARD_ERROR_OF_MEAN|336.0|||TWO_SIDED|95.0|-979.0|346.0|||||A positive value for the estimate would represent more steps per day for the CSTEX arm compared to the SOC-ED arm.|||346|-979|
91553811|NCT04093869|182994256|SUPERIORITY||Mean Difference (Net)|14.7|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-5.0|34.0||||||||34|-5|
91553812|NCT04093869|182994257|SUPERIORITY||Mean Difference (Net)|0.0034|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.1|0.11|||||A negative value for the estimate would represent a better QOL survey score for the CSTEX arm compared to the SOC-ED arm.|||0.11|-0.1|
91553813|NCT04093869|182994258|SUPERIORITY||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.22|0.3|||||A negative value for the estimate would represent a better Frailty index score for the CSTEX arm compared to the SOC-ED arm.|||0.30|-0.22|
91553814|NCT04093869|182994259|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.17||||||||0.17|-0.20|
91553815|NCT04093869|182994260|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.13|0.1||||||||0.10|-0.13|
91553816|NCT04093869|182994261|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.12|0.07||||||||0.07|-0.12|
91553817|NCT04093869|182994262|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.83|1.6|||||A positive value for the estimate represents better self-efficacy for the CSTEX arm compared to the SOC-ED arm.|||1.60|-0.83|
91553818|NCT01499368|182994264|NON_INFERIORITY|Non-inferiority: The Lower limit is not lower than -15%||||||0.05|||||||Chi-squared|||||||0.05
91553819|NCT01499368|182994265|NON_INFERIORITY|Non-Inferiority||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.05
91553820|NCT01527188|182994279|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-198.18||||0.0427|TWO_SIDED|95.0|-389.82|-6.55|||ANCOVA|||||-6.55|-389.82|0.0427
91553821|NCT01527188|182994279|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-171.82||||0.0793||95.0|-363.87|20.24|||ANCOVA|||||20.24|-363.87|0.0793
91553822|NCT01527188|182994279|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-118.43|||||TWO_SIDED|95.0|-305.9|69.04|||ANCOVA|||The statistical test is not applicable due to the step-down approach performed to address the multiplicity issue.||69.04|-305.90|
91553823|NCT01527188|182994280|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-125.61||||0.0323||95.0|-240.53|-10.69|||ANCOVA|||||-10.69|-240.53|0.0323
91553824|NCT01527188|182994280|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-122.23||||0.0376||95.0|-237.38|-7.08|||ANCOVA|||||-7.08|-237.38|0.0376
91553825|NCT01527188|182994280|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-91.18||||0.1119||95.0|-203.74|21.38|||ANCOVA|||||21.38|-203.74|0.1119
91767650|NCT00496015|183424397|SUPERIORITY|Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%.|Difference in percentages|22.18|||||TWO_SIDED|95.0|11.78|32.11||||||||32.11|11.78|
91553826|NCT04518943|182994302|SUPERIORITY||Mean Difference (Net)|-634.0||||0.418|TWO_SIDED|90.0|-1924.0|655.0|||linear mixed model|||This is the results of financial vs non-financial reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignment, linear week with a spline at week 12, and interactions between factors and weeks.||655|-1924|0.418
91553827|NCT04518943|182994302|SUPERIORITY||Mean Difference (Net)|-1697.0||||0.033|TWO_SIDED|90.0|-3000.0|-385.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-385|-3000|0.033
91553828|NCT04518943|182994302|SUPERIORITY||Mean Difference (Net)|820.0||||0.248|TWO_SIDED|90.0|-347.0|1988.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1988|-347|0.248
91553829|NCT04518943|182994302|SUPERIORITY||Mean Difference (Net)|1121.0||||0.125|TWO_SIDED|90.0|82.0|2323.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.|Positive values represent a positive effect of requests for advice on steps compared to no request for advice.|2323|82|0.125
91553830|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.53||0.739|TWO_SIDED|90.0|-1.05|0.7|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.|Positive values represent a positive effect of financial rewards compared to non-financial rewards.|0.70|-1.05|0.739
91553831|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|-0.51||||0.347|TWO_SIDED|90.0|-1.42|0.39|||Mixed Models Analysis||Positive values represent a positive effect of financial rewards compared to non-financial rewards.|This is the results of financial vs non-financial reward factor at week 24. It compares change in efficacy from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.39|-1.42|0.347
91553832|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|0.61||||0.293|TWO_SIDED|90.0|-0.35|1.57|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.57|-0.35|0.293
91553833|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|0.31||||0.599|TWO_SIDED|90.0|-0.67|1.3|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares efficacy at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.30|-0.67|0.599
91553834|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|1.49||||0.007|TWO_SIDED|90.0|0.58|2.4|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for PC to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.40|0.58|0.007
91553835|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|1.78||||0.002|TWO_SIDED|90.0|0.86|2.7|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.70|0.86|0.002
91767651|NCT05552027|183424454|SUPERIORITY||||||<|0.001||||||At the completion of scenario A (a full child safety seat installation), the participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.001
91767652|NCT05552027|183424454|SUPERIORITY||||||<|0.01||||||At the end of scenario B (loose harness straps), participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
91767653|NCT05552027|183424454|SUPERIORITY||||||<|0.01||||||At the end of scenario C (loose attachment at the base), like the other two scenarios, participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
91553836|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|1.02||||0.068|TWO_SIDED|90.0|0.1|1.94|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.94|0.10|0.068
91553837|NCT04518943|182994303|SUPERIORITY||Mean Difference (Net)|0.19||||0.74|TWO_SIDED|90.0|-0.76|1.14|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.14|-0.76|0.740
91553838|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|0.14||||0.481|TWO_SIDED|90.0|-0.19|0.47|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares intrinsic motivation in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator..||0.47|-0.19|0.481
91553839|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|0.18||||0.388|TWO_SIDED|90.0|-0.16|0.52|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares intrinsic motivation in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.52|-0.16|0.388
91553840|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|-0.02||||0.926|TWO_SIDED|90.0|-0.38|0.34|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.34|-0.38|0.926
91553841|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|-0.17||||0.446|TWO_SIDED|90.0|-0.54|0.2|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.20|-0.54|0.446
91767654|NCT01147666|183424474|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
91767655|NCT01147666|183424474|OTHER|||||||0.0698||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.0698
91553842|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|0.08||||0.711|TWO_SIDED|90.0|-0.27|0.42|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.42|-0.27|0.711
91553843|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|-0.2||||0.345|TWO_SIDED|90.0|-0.55|0.15|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.15|-0.55|0.345
91553844|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|0.02||||0.928|TWO_SIDED|90.0|-0.33|0.36|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for advice compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.36|-0.33|0.928
91767656|NCT01147666|183424474|OTHER|||||||0.1534||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.1534
91767657|NCT01147666|183424474|OTHER|||||||0.2657||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.2657
91767658|NCT01147666|183424475|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
91767659|NCT02748863|183424493|SUPERIORITY||Odds Ratio (OR)|717.42|||<|0.0001|TWO_SIDED|95.0|68.0|7569.56|||Regression, Logistic|||||7569.56|68.00|< 0.0001
91767660|NCT02748863|183424494|SUPERIORITY||Odds Ratio (OR)|168.39|||<|0.0001|TWO_SIDED|95.0|21.2|1337.22|||Regression, Logistic|||||1337.22|21.20|< 0.0001
91767661|NCT02748863|183424495|SUPERIORITY||Risk Difference (RD)|38.75|||<|0.0001|TWO_SIDED|95.0|27.41|50.09|||t-test, 2 sided|||||50.09|27.41|< 0.0001
91767662|NCT02748863|183424495|SUPERIORITY||Risk Difference (RD)|36.48|||<|0.0001|TWO_SIDED|95.0|25.19|47.76|||t-test, 2 sided|||||47.76|25.19|< 0.0001
91767663|NCT02748863|183424497|SUPERIORITY||Odds Ratio (OR)|400.58|||<|0.0001|TWO_SIDED|95.0|47.48|3379.99|||Regression, Logistic|||||3379.99|47.48|< 0.0001
91767664|NCT01135134|183424510|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91767665|NCT01135134|183424511|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91767666|NCT03865446|183424540|OTHER||Geometric Means Ratio|130.91|||||TWO_SIDED|90.0|86.03|199.22|||||The model was an analysis of variance (ANOVA) model with unequal variance assumption and hepatic impairment group as fixed effect. Values were back-transformed from the log scale.|||199.22|86.03|
91553845|NCT04518943|182994304|SUPERIORITY||Mean Difference (Net)|-0.19||||0.372|TWO_SIDED|90.0|-0.55|0.16|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.16|-0.55|0.372
91553846|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|0.35||||0.767|TWO_SIDED|90.0|-1.6|2.3|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares phq8 mental health scores in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.3|-1.60|0.767
91553847|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|0.78||||0.5|TWO_SIDED|90.0|-1.12|2.69|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares phq8 mental health scores in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.69|-1.12|0.500
91553848|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|0.59||||0.631|TWO_SIDED|90.0|-1.43|2.61|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||2.61|-1.43|0.631
91553849|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|-0.62||||0.62|TWO_SIDED|90.0|-2.69|1.44|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||1.44|-2.69|0.620
91553850|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|0.17||||0.886|TWO_SIDED|90.0|-1.77|2.12|||Regression, Linear|||This is the results of pre-commitment (PC) vs no PC factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.12|-1.77|0.886
91553851|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|-0.07||||0.95|TWO_SIDED|-2.03|-2.03|1.88|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.88|-2.03|0.950
91767667|NCT03865446|183424541|OTHER||Geometric Means Ratio|104.41|||||TWO_SIDED|90.0|72.12|151.16|||||The model was an ANOVA model with unequal variance assumption and hepatic impairment group as fixed effect. Values are back-transformed from the log scale.|||151.16|72.12|
91553852|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|-1.45||||0.248|TWO_SIDED|90.0|-3.51|0.61|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares phq mental health scores at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.61|-3.51|0.248
91553853|NCT04518943|182994305|SUPERIORITY||Mean Difference (Net)|-1.23||||0.317|TWO_SIDED|90.0|-3.25|0.79|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares phq mental health scores at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.79|-3.25|0.317
91767668|NCT01329978|183424548|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4||||0.77|TWO_SIDED|95.0|-12.2|9.4||The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions.|The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.||9.4|-12.2|0.77
91553854|NCT04518943|182994306|SUPERIORITY||Mean Difference (Net)|-35.0||||0.972|TWO_SIDED|90.0|-1685.0|1616.0|||Mixed Models Analysis|||This is the results of financial vs non-financial reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1616|-1685|0.972
91553855|NCT04518943|182994306|SUPERIORITY||Mean Difference (Net)|-2428.0||||0.019|TWO_SIDED|90.0|-4134.0|-722.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-722|-4134|0.019
91553856|NCT04518943|182994306|SUPERIORITY||Mean Difference (Net)|418.0||||0.627|TWO_SIDED|90.0|-999.0|1836.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1836|-999|0.627
91553857|NCT04518943|182994306|SUPERIORITY||Mean Difference (Net)|195.0||||0.842|TWO_SIDED|90.0|-1417.0|1807.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1807|-1417|0.842
91553858|NCT06408870|182994313|OTHER||Ratio of adjusted geometric means [%]|103.88|||||TWO_SIDED|90.0|101.08|106.75|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual pair geometric coefficient of variation (gCV) \[%\] = 9.0."|The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.||106.75|101.08|
91553859|NCT06408870|182994314|OTHER||Ratio of adjusted geometric means [%]|105.32|||||TWO_SIDED|90.0|100.83|110.01|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual pair geometric coefficient of variation (gCV) \[%\] = 14.5."|The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.||110.01|100.83|
91553860|NCT06408870|182994315|OTHER||Ratio of adjusted geometric means [%]|103.76|||||TWO_SIDED|90.0|100.95|106.65|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual pair geometric coefficient of variation (gCV) \[%\] = 9.1."|The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.||106.65|100.95|
91553861|NCT00412607|182994449|SUPERIORITY_OR_OTHER_LEGACY||Percentage of mortality|13.3|||||ONE_SIDED|95.0||17.5|||Fisher Exact||The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.|"Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05."||17.5||
91553862|NCT03662022|182994455|SUPERIORITY||incidence rate ratio|0.95|||<|0.017|TWO_SIDED|98.3|0.4|2.23||The significance level was determined at 0.017, to account for the fact that we made three comparisons, thus conclusions can be drawn by examining if the 98.3% CI for the incidence rate ratio (IRR) contains the critical value of 1.|Mixed Models Analysis|||||2.23|0.40|<0.017
91553863|NCT03662022|182994455|SUPERIORITY||incidence rate ratio|0.8||||0.017|TWO_SIDED|98.3|0.34|1.87|||Mixed Models Analysis|||||1.87|0.34|0.017
91553864|NCT03662022|182994455|SUPERIORITY||incidence rate ratio|0.58|||<|0.017|TWO_SIDED|98.3|0.22|1.56|||Mixed Models Analysis|||||1.56|0.22|<0.017
91553865|NCT04024059|182994456|SUPERIORITY||Odds Ratio (OR)|1.737|||=|0.22|TWO_SIDED|95.0|0.719|4.195|||Regression, Logistic|||||4.195|0.719|=0.22
91553866|NCT04024059|182994456|SUPERIORITY||Odds Ratio (OR)|1.035|||=|0.938|TWO_SIDED|95.0|0.435|2.461|||Regression, Logistic|||||2.461|0.435|=0.938
91553867|NCT04024059|182994457|SUPERIORITY||Odds Ratio (OR)|1.783|||=|0.202|TWO_SIDED|95.0|0.733|4.336|||Regression, Logistic|||||4.336|0.733|=0.202
91553868|NCT04024059|182994457|SUPERIORITY||Odds Ratio (OR)|1.38|||=|0.474|TWO_SIDED|95.0|0.571|3.336|||Regression, Logistic|||||3.336|0.571|=.474
91553869|NCT04024059|182994458|SUPERIORITY||Odds Ratio (OR)|0.669|||=|0.328|TWO_SIDED|95.0|0.299|1.497|||Regression, Logistic|||||1.497|0.299|=0.328
91553870|NCT04024059|182994458|SUPERIORITY||Odds Ratio (OR)|0.724|||=|0.435|TWO_SIDED|95.0|0.322|1.627|||Regression, Logistic|||||1.627|0.322|=0.435
91553871|NCT02360371|182994459|SUPERIORITY|||||||0.567|||||||Mixed methods|||||||0.567
91553872|NCT02360371|182994460|SUPERIORITY|||||||0.805|||||||Mixed Model|||||||0.805
91553873|NCT04174170|182994507|SUPERIORITY||Treatment Difference|1.03||||0.5165|TWO_SIDED|95.0|-2.09|4.16|||MMRM|||||4.16|-2.09|0.5165
91553874|NCT04174170|182994507|SUPERIORITY||Treatment Difference|-0.71||||0.6593|TWO_SIDED|95.0|-3.88|2.46|||MMRM|||||2.46|-3.88|0.6593
91553875|NCT04174170|182994508|SUPERIORITY||Treatment Difference|0.03||||0.8215|TWO_SIDED|95.0|-0.25|0.31||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.31|-0.25|0.8215
91553876|NCT04174170|182994508|SUPERIORITY||Treatment Difference|-0.03||||0.8584|TWO_SIDED|95.0|-0.31|0.26||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.26|-0.31|0.8584
91553877|NCT04174170|182994509|SUPERIORITY||Treatment Difference|-4.16||||0.2331|TWO_SIDED|95.0|-11.0|2.69||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||2.69|-11.00|0.2331
91553878|NCT04174170|182994509|SUPERIORITY||Treatment Difference|-8.83||||0.0134|TWO_SIDED|95.0|-15.82|-1.85||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||-1.85|-15.82|0.0134
91553879|NCT04602611|182994519|SUPERIORITY||Coefficient of negative binomial model|0.0547||||0.8|TWO_SIDED|95.0|-0.368|0.4773||The a priori threshold for statistical significance was 0.025.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.||0.4773|-0.3680|0.80
91767669|NCT01329978|183424548|SUPERIORITY_OR_OTHER||Difference in proportions|-0.4||||0.93|TWO_SIDED|95.0|-10.8|9.9||The p-value is based on the CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel|The difference in proportions and its 95% CI were calculated based on stratum-adjusted MH proportions.||The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL).||9.9|-10.8|0.93
91767670|NCT00287716|183424584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.||0.95|0.44|0.023
91767671|NCT00287716|183424590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.515|TWO_SIDED|95.0|0.5|1.42|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.||1.42|0.50|0.515
91767672|NCT02294058|183424593|SUPERIORITY||Rate Ratio|0.518|||<|0.0001|TWO_SIDED|95.0|0.405|0.663||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, Baseline age, number of gadolinium enhancing (GdE) lesions and included the natural log transformation of time as an offset term.||||0.663|0.405|<0.0001
91767673|NCT02294058|183424593|SUPERIORITY||Rate Ratio|0.688||||0.0013|TWO_SIDED|95.0|0.547|0.864||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, Baseline age and the number of GdE lesions, and included the natural log transformation of time on study as an offset term.||||0.864|0.547|0.0013
91767674|NCT02294058|183424594|SUPERIORITY||Rate Ratio|0.517|||<|0.0001|TWO_SIDED|95.0|0.427|0.625||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.625|0.427|<0.0001
91767675|NCT02294058|183424594|SUPERIORITY||Rate Ratio|0.754||||0.0032|TWO_SIDED|95.0|0.625|0.91||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.910|0.625|0.0032
91767676|NCT02294058|183424595|SUPERIORITY||Rate Ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.256|0.536||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.536|0.256|<0.0001
91767677|NCT02294058|183424595|SUPERIORITY||Rate Ratio|0.662||||0.0182|TWO_SIDED|95.0|0.471|0.932||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.932|0.471|0.0182
91767678|NCT02294058|183424596|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.3055|TWO_SIDED|95.0|0.34|1.402|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age, and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.402|0.340|0.3055
91767679|NCT02294058|183424596|SUPERIORITY||Hazard Ratio (HR)|0.886||||0.7163|TWO_SIDED|95.0|0.46|1.705|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.705|0.460|0.7163
91767680|NCT02294058|183424597|SUPERIORITY||Hazard Ratio (HR)|1.238||||0.6725|TWO_SIDED|95.0|0.46|3.337|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.337|0.460|0.6725
91767681|NCT02294058|183424597|SUPERIORITY||Hazard Ratio (HR)|1.535||||0.3755|TWO_SIDED|95.0|0.595|3.963|||Cox proportional hazard model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.963|0.595|0.3755
91767682|NCT02294058|183424598|SUPERIORITY||Difference in Percentages|10.88||||0.0006|TWO_SIDED|95.0|4.84|16.92|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per Interactive Voice Response System (IVRS)||||16.92|4.84|0.0006
91767683|NCT02294058|183424598|SUPERIORITY||Difference in Percentages|5.12||||0.113|TWO_SIDED|95.0|-1.07|11.32|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per IVRS.||||11.32|-1.07|0.1130
91767684|NCT02294058|183424599|SUPERIORITY||Difference in Percentages|4.53||||0.118|TWO_SIDED|95.0|-1.19|10.24|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||10.24|-1.19|0.1180
91767685|NCT02294058|183424599|SUPERIORITY||Difference in percentages|2.95||||0.3023|TWO_SIDED|95.0|-2.7|8.6|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||8.60|-2.70|0.3023
91553880|NCT04602611|182994520|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance was 0.025.|Fisher Exact|No adjustments were made in this analysis.||The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.|The proportions of evaluable subjects surviving at 6 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 52/87(60%) evaluable subjects were alive at 6 months and 35/87 (40%) were not. In the ONN + SOC arm, 58/95 (61%) evaluable subjects were alive at 6 months and 37/95 (39%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.88.|||0.88
91553881|NCT04602611|182994521|SUPERIORITY|||||||0.74||||||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Fisher Exact|No adjustments were made in this analysis.|||The proportions of evaluable subjects surviving at 12 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 23/87(26%) evaluable subjects were alive at 12 months and 64/87(74%) were not. In the ONN + SOC arm, 28/95 (29%) evaluable subjects were alive at 6 months and 67/95 (71%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.74.|||0.74
91553882|NCT04602611|182994522|SUPERIORITY||Coefficient of negative binomial model|0.1574||||0.57|TWO_SIDED|95.0|-0.3905|0.7054||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.7054|-0.3905|0.57
91553883|NCT04602611|182994523|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.45|TWO_SIDED|95.0|0.57|1.309||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Log Rank|Unadjusted log-rank test|The estimated hazard ratio was associated with Oncology Nurse Navigation with reference to Standard of Care; the model was estimated without adjustments (the sole covariate was treatment).|||1.309|0.570|0.45
91553884|NCT04602611|182994524|SUPERIORITY||Coefficient of negative binomial model|-0.4194||||0.21|TWO_SIDED|95.0|-1.0763|0.2374||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.2374|-1.0763|0.21
91553885|NCT04602611|182994525|SUPERIORITY||Odds Ratio (OR)|3.28|||<|0.01|TWO_SIDED|95.0|1.75|6.15||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Logistic|Model was estimated without adjustments (the sole covariate was treatment).|The estimated odds ratio was associated with Oncology Nurse Navigation with reference to Standard of Care.|||6.15|1.75|<0.01
91553886|NCT04602611|182994526|SUPERIORITY||Slope|-2.6939||||0.11|TWO_SIDED|95.0|-5.9538|0.5659||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|Model was estimated without adjustments (sole covariate was treatment; slope was the estimated treatment effect) using 180 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.5659|-5.9538|0.11
91553887|NCT04602611|182994527|SUPERIORITY||Slope|0.1197||||0.09|TWO_SIDED|95.0|-0.0315|0.4378||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|This univariate model was not adjusted for other covariates; this model was estimated using 84 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.4378|-0.0315|0.09
91553888|NCT04675034|182994532|SUPERIORITY||Combined estimate for LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.416||0.36|TWO_SIDED|95.0|-0.968|0.67|||ANCOVA|Least Square (LS) mean and treatment group difference with associated 95% confidence intervals (CIs) are modelled using ANCOVA on imputed data.||||0.670|-0.968|0.360
91553889|NCT04675034|182994532|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.418||0.029|TWO_SIDED|95.0|-1.619|0.027|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.027|-1.619|0.029
91767686|NCT02294058|183424600|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and EDSS category per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||<0.0001
91767687|NCT02294058|183424600|SUPERIORITY|||||||0.0615|||||||Rank ANCOVA|Adjusted for region and EDSS Scale per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||0.0615
91767688|NCT02294058|183424601|SUPERIORITY||LS Mean Difference|0.034||||0.129|TWO_SIDED|95.0|-0.01|0.077|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score.||||0.077|-0.010|0.1290
91553890|NCT04675034|182994532|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.413||0.026|TWO_SIDED|95.0|-1.618|0.009|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.009|-1.618|0.026
91767689|NCT02294058|183424601|SUPERIORITY||LS Mean Difference|0.015||||0.4942|TWO_SIDED|95.0|-0.028|0.059|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score||||0.059|-0.028|0.4942
91767690|NCT02294058|183424602|SUPERIORITY||Mean Difference (Final Values)|1.642||||0.0364|TWO_SIDED|95.0|0.104|3.18|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||3.180|0.104|0.0364
91767691|NCT02294058|183424602|SUPERIORITY||Mean Difference (Final Values)|1.024||||0.1905|TWO_SIDED|95.0|-0.51|2.559|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||2.559|-0.510|0.1905
91553891|NCT04675034|182994532|SUPERIORITY||Combined estimate for LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.424||0.083|TWO_SIDED|95.0|-1.423|0.245|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.245|-1.423|0.083
91553892|NCT03839446|182994594|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.777|TWO_SIDED|95.0|0.18|3.65|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.65|0.18|0.777
91553893|NCT03839446|182994594|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.2|TWO_SIDED|95.0|0.96|1.01|||Regression, Cox|||Percent of blasts present in the bone marrow.||1.01|0.96|0.200
91553894|NCT03839446|182994594|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.014|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.014
91553895|NCT03839446|182994595|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.801|TWO_SIDED|95.0|0.17|3.86|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.86|0.17|0.801
91553896|NCT03839446|182994595|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.168|TWO_SIDED|95.0|0.95|1.01|||Regression, Cox|||% bone marrow blasts||1.01|0.95|0.168
91553897|NCT03839446|182994595|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.015|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.015
91553898|NCT03142009|182994603|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Mixed Models Analysis|||||-.04|-.45|.021
91553899|NCT03142009|182994604|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.075|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||||0.15|-.01|.075
91553900|NCT04319887|182994605|OTHER||||||||||||||||||statistical analysis section may be deleted|||
91553901|NCT03982186|182994615|SUPERIORITY||Difference of proportions|-2.3|||=|0.848|TWO_SIDED|90.0|-5.97|1.38|||Mantel Haenszel|||||1.38|-5.97|= 0.848
91553902|NCT03982186|182994615|SUPERIORITY||Difference of proportions|7.4|||=|0.027|TWO_SIDED|90.0|1.07|13.68|||Mantel Haenszel|||||13.68|1.07|= 0.027
91553903|NCT03982186|182994615|SUPERIORITY||Difference of proportions|9.1|||=|0.917|TWO_SIDED|90.0|4.16|14.07|||Mantel Haenszel|||||14.07|4.16|= 0.917
91553904|NCT03982186|182994615|SUPERIORITY||Difference of proportions|-6.7|||=|0.917|TWO_SIDED|90.0|-14.67|1.25|||Mantel Haenszel|||||1.25|-14.67|= 0.917
91553905|NCT03512301|182994712|OTHER||Accuracy|0.6587|||||TWO_SIDED|95.0|0.569|0.7408||||||||0.7408|0.5690|
91553906|NCT03512301|182994712|OTHER||Sensitivity|0.8736|||||TWO_SIDED|||||||||||||
91553907|NCT03512301|182994712|OTHER||Specificity|0.4872|||||TWO_SIDED|||||||||||||
91553908|NCT03512301|182994712|OTHER||Positive Predictive Value|0.7917|||||TWO_SIDED|||||||||||||
91553909|NCT03512301|182994712|OTHER||Negative Predictive Value|0.6333|||||TWO_SIDED|||||||||||||
91553910|NCT03512301|182994712|OTHER||Sensitivity|0.1212|||||TWO_SIDED|||||||||||||
91553911|NCT03512301|182994712|OTHER||Specificity|0.9032|||||TWO_SIDED|||||||||||||
91553912|NCT03512301|182994712|OTHER||Positive Predictive Value|0.3077|||||TWO_SIDED|||||||||||||
91553913|NCT03512301|182994712|OTHER||Negative Predictive Value|0.7434|||||TWO_SIDED|||||||||||||
91553914|NCT03512301|182994712|OTHER||Sensitivity|0.5|||||TWO_SIDED|||||||||||||
91553915|NCT03512301|182994712|OTHER||Specificity|0.8833|||||TWO_SIDED|||||||||||||
91553916|NCT03512301|182994712|OTHER||Positive Predictive Value|0.1765|||||TWO_SIDED|||||||||||||
91553917|NCT03512301|182994712|OTHER||Negative Predictive Value|0.9725|||||TWO_SIDED|||||||||||||
91553918|NCT03512301|182994712|OTHER||Quadratic Weighted Kappa|0.4446|||||TWO_SIDED|95.0|0.2791|0.6101||||||||0.6101|0.2791|
91553919|NCT03512301|182994713|OTHER|Linear Regression. Power calculations for linear regression between CAMCI and MoCA were found to be sufficiently powered with a Pearson's R of at least 0.3 at 80% power and that equated to a test-set size of 98.|Pearson Correlation|0.5073|||||TWO_SIDED|95.0|0.3892|0.6091|||||Linear Regression Equation: \[CAMCI Score\] = -5.42 + 1.40 X \[MoCA Score\]|||0.6091|0.3892|
91553920|NCT03512301|182994713|OTHER||Accuracy|0.5556|||||TWO_SIDED|95.0|0.4644|0.644||||||||0.6440|0.4644|
91553921|NCT03512301|182994713|OTHER||Sensitivity|0.9747|||||TWO_SIDED|||||||||||||
91553922|NCT03512301|182994713|OTHER||Specificity|0.3913|||||TWO_SIDED|||||||||||||
91553923|NCT03512301|182994713|OTHER||Positive Predictive Value|0.5625|||||TWO_SIDED|||||||||||||
91553924|NCT03512301|182994713|OTHER||Negative Predictive Value|0.9|||||TWO_SIDED|||||||||||||
91553925|NCT03512301|182994713|OTHER||Sensitivity|0.1905|||||TWO_SIDED|||||||||||||
91553926|NCT03512301|182994713|OTHER||Specificity|0.9841|||||TWO_SIDED|||||||||||||
91553927|NCT03512301|182994713|OTHER||Positive Predictive Value|0.9231|||||TWO_SIDED|||||||||||||
91553928|NCT03512301|182994713|OTHER||Negative Predictive Value|0.5487|||||TWO_SIDED|||||||||||||
91553929|NCT03512301|182994713|OTHER||Sensitivity|0.6667|||||TWO_SIDED|||||||||||||
91553930|NCT03512301|182994713|OTHER||Specificity|0.8917|||||TWO_SIDED|||||||||||||
91553931|NCT03512301|182994713|OTHER||Positive Predictive Value|0.2353|||||TWO_SIDED|||||||||||||
91553932|NCT03512301|182994713|OTHER||Negative Predictive Value|0.9817|||||TWO_SIDED|||||||||||||
91553933|NCT03512301|182994713|OTHER||Quadratic Weighted Kappa|0.3931|||||TWO_SIDED|95.0|0.2401|0.5461||||||||0.5461|0.2401|
91553934|NCT02231749|182994730|SUPERIORITY||Stratified Difference|16.0|||<|0.0001|TWO_SIDED|95.0|9.8|22.2|||DerSimonian and Laird Test|||||22.2|9.8|<0.0001
91553935|NCT02231749|182994731|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|99.8|0.44|0.89|||Log Rank|||||0.89|0.44|<0.0001
91553936|NCT02231749|182994732|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0331|TWO_SIDED|99.1|0.64|1.05|||Log Rank|||||1.05|0.64|0.0331
91553937|NCT02231749|182994733|SUPERIORITY||Stratified Difference|7.2||||0.0191|TWO_SIDED|95.0|1.8|12.7|||DerSimonian and Laird Test|||||12.7|1.8|0.0191
91553938|NCT02231749|182994734|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0003|TWO_SIDED|99.8|0.49|0.95|||Log Rank|||||0.95|0.49|0.0003
91553939|NCT02231749|182994735|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8498|TWO_SIDED|99.1|0.79|1.23|||Log Rank|||||1.23|0.79|0.8498
91553940|NCT02532621|182994751|NON_INFERIORITY|"Cumulative patency at 6 months was evaluated using the estimated patency from a Kaplan Meier survival analysis. The test statistic took the following form:~Z-test statistic = (P - 0.75) / SE (P) Where, (P) represents the Kaplan Meier estimate of cumulative patency at 6 months, and the standard error SE (P) is estimated using the method of Peto et al (1977)."|Cumulative patency|92.1|||<|0.001|ONE_SIDED|95.0||||A one-sided p-value of 0.025 was considered evidence of statistical significance for the primary study endpoint.|one-sided binomial exact test|||"The primary endpoint was evaluated by comparison with a performance goal of 75% that was determined from medical literature.~The sample size of 158 patients was estimated as follows:~* Kaplan-Meier estimate of cumulative patency rate at 6 months (exact binomial estimation for sample size)~* Type I error (alpha): 0.025 (one-sided)~* 80% Statistical power~* 8% Lost-to-follow up rate"||||<0.001
91553941|NCT00709956|182994771|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-1.5||||0.7883|TWO_SIDED|95.0|-12.3|9.4||If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied|Generalized linear model|Subject (sequence), treatment, and period as fixed effect||With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.||9.4|-12.3|0.7883
91553942|NCT04079517|182994774|NON_INFERIORITY|Comparing mean difference in symptom score (95% confidence intervals). Post hoc analysis. Not powered, but to give an indication of differences between standard dose (20mg) and the non-approved dose (10mg).|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|||||||Post hoc analysis. Not powered, but to give an indication on differences in symptom score between standard dose (20mg) and the non-approved dose (10mg).||Post hoc analysis. Not powered, but to give an indication on differences between standard dose (20mg) and the non-approved dose (10mg).|||
91553943|NCT04940624|182994775|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-15.64|||=|0.061|TWO_SIDED|95.0|-31.3|0.24||The p-value was calculated by Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) were based on the Hodges-Lehmann estimation.|||0.24|-31.30|=0.061
91553944|NCT04940624|182994776|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-14.29|||=|0.089|TWO_SIDED|95.0|-30.51|1.53||The p-value was calculated by the Rank ANCOVA model using treatment group, age stratum (≤6 years, \>6 years), and rank of baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||1.53|-30.51|=0.089
91553945|NCT04940624|182994777|SUPERIORITY||Odds Ratio (OR)|3.22|||=|0.01|TWO_SIDED|95.0|1.3|7.96|||Cochran-Mantel-Haenszel|The p-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by age stratum (≤6 years, \>6 years).||||7.96|1.30|=0.010
91553946|NCT04940624|182994778|SUPERIORITY||Odds Ratio (OR)|3.59|||=|0.008|TWO_SIDED|95.0|1.36|9.49|||Cochran-Mantel-Haenszel|The p-value was based on CMH test stratified by age stratum (≤6 years, \>6 years).||||9.49|1.36|=0.008
91553947|NCT04940624|182994780|SUPERIORITY||Odds Ratio (OR)|2.51|||=|0.004|TWO_SIDED|95.0|1.33|4.72|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.72|1.33|=0.004
91553948|NCT04940624|182994781|SUPERIORITY||Odds Ratio (OR)|2.58|||=|0.003|TWO_SIDED|95.0|1.37|4.87|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.87|1.37|=0.003
91553949|NCT04940624|182994782|SUPERIORITY||Odds Ratio (OR)|1.12|||=|0.741|TWO_SIDED|95.0|0.56|2.26|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Alertness||2.26|0.56|=0.741
91553950|NCT04940624|182994782|SUPERIORITY||Odds Ratio (OR)|1.04|||=|0.901|TWO_SIDED|95.0|0.54|2.02|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Communication||2.02|0.54|=0.901
91767692|NCT02294058|183424602|SUPERIORITY||Mean Difference (Final Values)|0.356||||0.7104|TWO_SIDED|95.0|-1.523|2.234|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||2.234|-1.523|0.7104
91767693|NCT02294058|183424602|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.8587|TWO_SIDED|95.0|-2.045|1.705|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||1.705|-2.045|0.8587
91767694|NCT02586623|183424646|SUPERIORITY||Cox Proportional Hazard|1.04||||0.803|TWO_SIDED|95.0|0.67|1.62|||Log Rank||Droxidopa / Placebo|||1.62|0.67|0.803
91767695|NCT00965250|183424713|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
91553951|NCT04940624|182994782|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.693|TWO_SIDED|95.0|0.58|2.28|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Disruptive Behaviors||2.28|0.58|=0.693
91553952|NCT04940624|182994783|SUPERIORITY||Least Square Mean Difference|-3.03|||=|0.189|TWO_SIDED|95.0|-7.59|1.52||P-value was based on MMRM analysis with change from baseline as outcome and baseline score as fixed continuous effect; treatment group, age stratum, analysis visit, and analysis visit by treatment group interaction as fixed categorical effects.|MMRM|||||1.52|-7.59|=0.189
91553953|NCT04940624|182994784|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.001|TWO_SIDED|95.0|1.87|7.13|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||7.13|1.87|<0.001
91553954|NCT04940624|182994785|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-9.97|||=|0.565|TWO_SIDED|95.0|-29.01|7.87|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||7.87|-29.01|=0.565
91553955|NCT04940624|182994786|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-8.13|||=|0.637|TWO_SIDED|94.0|-26.31|10.13|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||10.13|-26.31|=0.637
91767696|NCT00965250|183424714|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
91767697|NCT06172348|183424732|OTHER||Ratio of Adjusted Geometric Means|21.89|||||TWO_SIDED|90.0|19.31|24.8|||||Ratios (Test/Reference) and 90 percent (%) confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||24.80|19.31|
91553956|NCT04940624|182994787|SUPERIORITY||Least Square Mean Difference|0.79|||||TWO_SIDED|95.0|-3.81|5.4|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||5.40|-3.81|
91767698|NCT06172348|183424732|OTHER||Ratio of Adjusted Geometric Means|12.65|||||TWO_SIDED|90.0|11.21|14.27|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||14.27|11.21|
91553957|NCT04940624|182994788|SUPERIORITY||Least Square Mean Difference|5.6|||||TWO_SIDED|95.0|0.1|11.2||||||||11.2|0.1|
91553958|NCT04940624|182994789|SUPERIORITY||Least Square Mean Difference|-1.1|||||TWO_SIDED|95.0|-3.1|1.0|||||Least square mean difference was estimated using a linear model with treatment group and age stratum as factors.|||1.0|-3.1|
91553959|NCT04479787|182994790|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
91553960|NCT04479787|182994791|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||< 0.0001
91553961|NCT04479787|182994792|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
91553962|NCT04479787|182994793|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
91553963|NCT04479787|182994794|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
91553964|NCT04479787|182994795|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
91553965|NCT04479787|182994796|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
91553966|NCT04479787|182994797|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
91767699|NCT06172348|183424733|OTHER||Ratio of Adjusted Geometric Means|86.49|||||TWO_SIDED|90.0|79.11|94.54|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||94.54|79.11|
91767700|NCT06172348|183424733|OTHER||Ratio of Adjusted Geometric Means|76.99|||||TWO_SIDED|90.0|70.65|83.9|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||83.90|70.65|
91553967|NCT04039113|182994801|SUPERIORITY||Rate Ratio|0.83||||0.1042|TWO_SIDED|90.0|0.64|1.06||1-sided p-value|Negative Binomial|||||1.06|0.64|0.1042
91553968|NCT04039113|182994801|SUPERIORITY||Rate Ratio|0.83||||0.2085|TWO_SIDED|95.0|0.61|1.11||2-sided p-value|Negative Binomial|||||1.11|0.61|0.2085
91553969|NCT00353496|182994813|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||<|0.001|TWO_SIDED|95.0|0.3|0.73||No p-value adjustment for multiple comparisons.|Log Rank|The log rank test was stratified according to progression status at baseline and prior therapy.||||0.73|0.30|<0.001
91553970|NCT02502266|182994928|SUPERIORITY||Hazard Ratio (HR)|0.649|||||TWO_SIDED|95.0|0.424|0.995|||||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||0.995|0.424|
91553971|NCT02502266|182994928|SUPERIORITY||Hazard Ratio (HR)|0.832|||||TWO_SIDED|95.0|0.539|1.284|||||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.284|0.539|
91553972|NCT02502266|182994928|SUPERIORITY||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.745|1.773|||||The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.773|0.745|
91553973|NCT02502266|182994929|SUPERIORITY||Hazard Ratio (HR)|0.796||||0.145|TWO_SIDED|98.0|0.597|1.06||The log rank test was stratified by the factors provided at randomization|Log Rank||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.060|0.597|0.145
91553974|NCT02502266|182994929|SUPERIORITY||Hazard Ratio (HR)|0.972||||1|TWO_SIDED|98.0|0.726|1.0|||Log Rank|The log rank test was stratified by the factors provided at randomization.|The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.00|0.726|1.0
91553975|NCT02502266|182994930|SUPERIORITY||Hazard Ratio (HR)|1.027|||||TWO_SIDED|98.0|0.771|1.368||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.368|0.771|
91553976|NCT02502266|182994930|OTHER|No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|98.0|0.795|1.413||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.413|0.795|
91553977|NCT05030584|182995053|SUPERIORITY||Difference in LS-means|-1.55|||<|0.0001|TWO_SIDED|95.0|-2.04|-1.05||The type I error rate was controlled at a one-sided α=0.025 level.|Mixed model repeated measures (MMRM)|||"For category Change from baseline."||-1.05|-2.04|<0.0001
91553978|NCT00357682|182995058|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.24||||0.068|TWO_SIDED|95.0|0.98|1.57|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in low dose PPI (20mg) patients to high dose PPI (80mg) patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and aspirin randomisation group.||1.57|0.98|0.068
91553979|NCT00357682|182995058|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.27||||0.037|TWO_SIDED|95.0|1.01|1.58|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in aspirin patients to non-aspirin patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and PPI randomisation group.||1.58|1.01|0.037
91553980|NCT00357682|182995059|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.36||||0.039|TWO_SIDED|95.0|1.01|1.82|||Accelerated Failure Time|||All recordings of death, regardless of the cause are used in this analysis and both PPI groups are compared.||1.82|1.01|0.039
91553981|NCT00357682|182995059|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.25||||0.159|TWO_SIDED|95.0|0.92|1.7|||Accelerated Failure Time|||There are 163 deaths in the aspirin comparison with all-cause mortality as the endpoint. Median follow-up is 8.9 years IQR: (8.2 , 10.0) Range: (0 , 11.5)||1.70|0.92|0.159
91553982|NCT00357682|182995060|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.04||||0.864|TWO_SIDED|95.0|0.67|1.61|||Accelerated Failure Time|||There are 81 diagnoses in the PPI dose comparison with adenocarcinoma oesophageal cancer as the endpoint. Median follow-up is 8.7 years IQR: (8.1 , 9.9)||1.61|0.67|0.864
91553983|NCT00357682|182995060|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.02||||0.921|TWO_SIDED|95.0|0.64|1.64|||Accelerated Failure Time|||There are 70 diagnoses of adenocarcinoma in the aspirin comparison. Median follow-up is 8.8 years, IQR: (8.1 , 10), Range: (0 , 11.5)||1.64|0.64|0.921
91553984|NCT00357682|182995061|SUPERIORITY|5% significance level is considered statistically significant.|Time Ratio|1.36||||0.119|TWO_SIDED|95.0|0.92|2.02|||Accelerated Failure Time|||There are 103 such diagnoses in the PPI dose comparison. Median follow-up is 8.7 years IQR: (8.1 , 9.9) Range: (0 , 11.48)||2.02|0.92|0.119
91553985|NCT00357682|182995061|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.51||||0.053|TWO_SIDED|95.0|1.0|2.29|||Accelerated Failure Time|||There are a total of 92 conversions to HGD in the aspirin comparison. Median follow-up is 8.8 years IQR (8.1 , 10.0) Range (0 , 11.5)||2.29|1.00|0.053
91553986|NCT05648890|182995112|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between MMSE and TEGEST test before operation.||||<0.0001
91553987|NCT05648890|182995113|OTHER|Spearman's ran correlation coefficient was used .|||||<|0.001|||||||Spearman's ran correlation coefficient|Spearman's ran correlation coefficient was used for correlation between two quantities.||Correlation between MMSE and TEGEST after operation||||< .001
91767701|NCT06172348|183424734|OTHER||Ratio of Adjusted Geometric Means|123.92|||||TWO_SIDED|90.0|105.16|146.02|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||146.02|105.16|
91553988|NCT05648890|182995114|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and Clock drawing test before operation.|Spearman's rank correlation coefficient was used.|||<0.0001
91553989|NCT05648890|182995115|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and clock drawing test after operation.||||<0.001
91553990|NCT05648890|182995116|OTHER|Spearman's rank correlation coefficient.|||||<|0.001|||||||Spearman's rank correlation coefficien|||Correlation between MMSE and Clock drawing test before operation.||||<0.001
91767702|NCT06172348|183424734|OTHER||Ratio of Adjusted Geometric Means|129.79|||||TWO_SIDED|90.0|111.51|151.06|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||151.06|111.51|
91553991|NCT05648890|182995116|OTHER|Mann-Whitney U test before operation.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Clock drawing before operation.||||0.023
91553992|NCT05648890|182995117|OTHER|Spearman's rank correlation coefficient|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between Clock drawing test and MMSE after operation.||||<0.0001
91553993|NCT05648890|182995118|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with MMSE before operation.||||<0.0001
91553994|NCT05648890|182995118|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with TEGEST before operation.||||<0.0001
91553995|NCT05648890|182995118|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with Clock drawing test before operation.||||<0.0001
91553996|NCT05648890|182995119|OTHER|Mann-Whitney U test.||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Respondents living at a house or in apartment and relationships with Clinical frailty scale.||||.562
91553997|NCT05648890|182995120|OTHER|Mann-Whitney test was used.||||||0.129|||||||Wilcoxon (Mann-Whitney)|||Respondents living with with family or alone and relationship with Clinical frailty scale.||||0.129
91553998|NCT05648890|182995121|OTHER|Mann-Whintney test was used.||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Relationship between respondents living at home with stairs and respondents living at home with an elevator and Clinical frailty scale.||||0.019
91767703|NCT06172348|183424735|OTHER||Ratio of Adjusted Geometric Means|107.48|||||TWO_SIDED|90.0|96.46|119.76|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||119.76|96.46|
91553999|NCT05550636|182995122|OTHER||adjusted gMean Ratio (%)|92.3|||||TWO_SIDED|90.0|79.3|107.4|||||Adjusted gMean ratio of test/reference (T/R). Intra-individual geometric coefficient of variation (gCV) = 23.9%|The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoint was logtransformed (natural logarithm) prior to fitting the ANOVA model. This model includes effects accounting for the sources of variation: treatment. The effect 'subjects' is considered as random, whereas the treatment effect is considered as fixed. Quantities were then back-transformed to the original scale to provide the point estimate and 90% confidence interval.||107.4|79.3|
91554000|NCT05550636|182995123|OTHER||adjusted gmean Ratio (%)|78.0|||||TWO_SIDED|90.0|68.9|88.2|||||Adjusted gMean ratio of test/reference (T/R). Intra-individual geometric coefficient of variation (gCV) = 19.4%|The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoint was logtransformed (natural logarithm) prior to fitting the ANOVA model. This model includes effects accounting for the sources of variation: treatment. The effect 'subjects' is considered as random, whereas the treatment effect is considered as fixed. Quantities were then back-transformed to the original scale to provide the point estimate and 90% confidence interval.||88.2|68.9|
91554001|NCT05550636|182995124|OTHER||adjusted gmean Ratio (%)|89.8|||||TWO_SIDED|90.0|76.9|104.9|||||Adjusted gMean ratio of test/reference (T/R). Intra-individual geometric coefficient of variation (gCV) = 24.4|The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoint was logtransformed (natural logarithm) prior to fitting the ANOVA model. This model includes effects accounting for the sources of variation: treatment. The effect 'subjects' is considered as random, whereas the treatment effect is considered as fixed. Quantities were then back-transformed to the original scale to provide the point estimate and 90% confidence interval.||104.9|76.9|
91554002|NCT06393127|182995235|OTHER||Ratio of adjusted geometric means [%]|105.03|||||TWO_SIDED|90.0|99.07|111.36|||||Ratio \[%\] = (adjusted geometric mean of T / adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.8|"Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: subjects within sequences as random effect, sequence, period and treatment as fixed effects. These quantities were then back-transformed to the original scale."||111.36|99.07|
91554003|NCT06393127|182995236|OTHER||Ratio of adjusted geometric means [%]|113.32|||||TWO_SIDED|90.0|102.7|125.05|||||Ratio \[%\] = (adjusted geometric mean of T / adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 32.8|"Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: subjects within sequences as random effect, sequence, period and treatment as fixed effects. These quantities were then back-transformed to the original scale."||125.05|102.70|
91554004|NCT06393127|182995237|OTHER||Ratio of adjusted geometric means [%]|104.95|||||TWO_SIDED|90.0|99.1|111.14|||||Ratio \[%\] = (adjusted geometric mean of T / adjusted geometric mean R)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.5|"Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: subjects within sequences as random effect, sequence, period and treatment as fixed effects. These quantities were then back-transformed to the original scale."||111.14|99.10|
91554005|NCT02446600|182995238|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.077|TWO_SIDED|95.0|0.663|1.105||The p-value is one-sided. Per the protocol, the statistical significance threshold was \<0.025. Type 1 error was controlled using hierarchical testing strategy.|Log Rank|The log rank test was stratified by the minimization factors provided at randomization|The hazard ratio estimate compares olaparib+cedirinib to chemotherapy. If olaparib+cedirinib is superior, the hazard ratio is \<1.0.|Arm II was suspended for futility at the interim analysis so was not analyzed at the final analysis.||1.105|0.663|0.077
91554006|NCT04955431|182995317|OTHER|We performed a 2-way Repeated Measures ANOVA to compare changes in blood IL-6 levels from baseline to post simulated firefighting on control days (Normal Sleep) and experimental days (Sleep Restriction).|||||<|0.05|||||||ANOVA|||||||<0.05
91554007|NCT04955431|182995318|OTHER|RM-ANOVA|||||>|0.05|||||||ANOVA|||||||>0.05
91554008|NCT02112916|182995335|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.074|TWO_SIDED|95.0|0.561|1.091|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.||1.091|0.561|0.074
91767704|NCT06172348|183424735|OTHER||Ratio of Adjusted Geometric Means|109.63|||||TWO_SIDED|90.0|99.19|121.17|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||121.17|99.19|
91554009|NCT04098575|182995468|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91554010|NCT04098575|182995469|OTHER|||||||0.835|||||||Chi-squared|||||||0.835
91554011|NCT04098575|182995470|OTHER||||||<|0.001|||||||Chi-squared|||Antihypertensive drugs||||<0.001
91554012|NCT04098575|182995470|OTHER||||||<|0.001|||||||Chi-squared|||Lipid-lowering agents||||<0.001
91554013|NCT04098575|182995470|OTHER||||||<|0.001|||||||Chi-squared|||Antiplatelet, anticoagulant drugs||||<0.001
91767705|NCT04037891|183424754|SUPERIORITY||Difference of percentage of participants|16.7|||||TWO_SIDED|95.0|-53.57|72.99||||||||72.99|-53.57|
91767706|NCT04037891|183424754|SUPERIORITY||Difference of percentage of participants|33.3|||||TWO_SIDED|95.0|-25.45|78.39||||||Comparison of incidence of ocular TEAE in all patients receiving rVA576 (part 1 and 2) vs placebo||78.39|-25.45|
91767707|NCT04194944|183424763|SUPERIORITY||Hazard Ratio (HR)|0.465||||0.0002|TWO_SIDED|95.0|0.309|0.699|||Log Rank|||||0.699|0.309|0.0002
91554014|NCT04098575|182995470|OTHER||||||<|0.001|||||||Chi-squared|||Glucose-lowering therapies||||<0.001
91554015|NCT04098575|182995471|OTHER||||||<|0.001|||||||Chi-squared|||Group: \< 65||||<0.001
91554016|NCT04098575|182995471|OTHER|||||||0.001|||||||Chi-squared|||Group: 65 ≤ 75||||0.001
91554017|NCT04098575|182995471|OTHER||||||<|0.001|||||||Chi-squared|||Group: 75 - 80||||<0.001
91554018|NCT04098575|182995471|OTHER||||||<|0.002|||||||Chi-squared|||Group: \> 80||||<0.002
91554019|NCT04098575|182995472|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91554020|NCT04098575|182995473|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91554021|NCT04098575|182995474|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91554022|NCT04098575|182995475|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
91767708|NCT04194944|183424764|SUPERIORITY||Hazard Ratio (HR)|0.482||||0.0001|TWO_SIDED|95.0|0.331|0.7|||Log Rank|||||0.700|0.331|0.0001
91554023|NCT04098575|182995476|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
91554024|NCT04098575|182995477|OTHER||||||<|0.001|||||||Chi-squared|||Insulin||||<0.001
91554025|NCT04098575|182995477|OTHER||||||<|0.001|||||||Chi-squared|||Metformin||||<0.001
91554026|NCT04098575|182995477|OTHER|||||||0.157|||||||Chi-squared|||Acarbose||||0.157
91767709|NCT04194944|183424765|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3996|TWO_SIDED|95.0|0.7|3.4|||Cochran-Mantel-Haenszel|||||3.4|0.7|0.3996
91554027|NCT04098575|182995477|OTHER||||||<|0.001|||||||Chi-squared|||Sulfonylurea||||<0.001
91554028|NCT04098575|182995477|OTHER|||||||0.071|||||||Chi-squared|||Dipeptidyl peptidase-4 (DPP-4) inhibitors||||0.071
91554029|NCT04098575|182995477|OTHER|||||||0.317|||||||Chi-squared|||Glucagon-like peptide-1 (GLP-1) agonists||||0.317
91554030|NCT04098575|182995477|OTHER||||||<|0.001|||||||Chi-squared|||Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin||||<0.001
91554031|NCT04098575|182995478|OTHER||||||<|0.002|||||||Chi-squared|||||||<0.002
91554032|NCT04098575|182995481|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.000
91554033|NCT02567435|182995522|SUPERIORITY||3-Year EFS|65.8||||0.44|TWO_SIDED||||||Log Rank|||||||0.44
91554034|NCT02567435|182995523|SUPERIORITY||3-Year OS|78.2||||0.56|TWO_SIDED||||||Log Rank|||||||0.56
91554035|NCT02166463|182995528|SUPERIORITY|||||||0.0001|||||||Log Rank|Used a one-sided log-rank test between 2 arms||Assuming a 3-year EFS of 82% (5-year EFS of 78.4%, long term EFS of 76%) for standard arm, the study will have approximately 86% power for detecting an 8% improvement in 3-year EFS in the Bv-AVEPC arm (3-year EFS of 90%, 5-year EFS of 88.0%, long term EFS of 86.7%) in log rank test.||||0.0001
91554036|NCT06415045|182995557|OTHER||Ratios of adjusted geometric means [%]|115.21|||||TWO_SIDED|90.0|106.55|124.58|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 13.5|Relative bioavailability of Nerandomilast administered in fed state (Test) compared with Nerandomilast administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||124.58|106.55|
91554037|NCT06415045|182995558|OTHER||Ratios of adjusted geometric means [%]|85.82|||||TWO_SIDED|90.0|68.8|107.06|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 39.4|Relative bioavailability of Nerandomilast administered in fed state (Test) compared with Nerandomilast administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||107.06|68.80|
91554038|NCT06415045|182995559|OTHER||Ratios of adjusted geometric means [%]|115.07|||||TWO_SIDED|90.0|106.38|124.46|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 13.5|Relative bioavailability of Nerandomilast administered in fed state (Test) compared with Nerandomilast administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||124.46|106.38|
91554039|NCT00391443|182995573|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.211|TWO_SIDED|95.0|0.658|1.097|||Log Rank|||||1.097|0.658|0.2110
91554040|NCT00391443|182995574|SUPERIORITY_OR_OTHER_LEGACY||Relative risk reduction|0.17||||0.2542|TWO_SIDED|95.0|-0.13|0.39|||Fisher Exact|||||0.39|-0.13|0.2542
91554041|NCT02890355|182995583|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.28|TWO_SIDED|95.0|0.85|1.78||a priori threshold for statistical significance, one sided p=0.02|Log Rank|||||1.78|0.85|0.28
91554042|NCT02890355|182995585|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.09|TWO_SIDED|95.0|0.96|2.02|||Log Rank|||||2.02|0.96|0.09
91554043|NCT03391466|182995604|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.|Hazard Ratio (HR)|0.398|||<|0.0001|TWO_SIDED|95.0|0.308|0.514||Stratified (randomization factors) log-rank p-value.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% confidence interval (CI)), stratified using randomization stratification factors.|||0.514|0.308|<0.0001
91554044|NCT03391466|182995605|SUPERIORITY|One-sided p-value based on Cochran-Mantel-Haenszel (CMH) test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.|Difference in ORR|33.1|||<|0.0001|TWO_SIDED|95.0|23.2|42.1||Stratified (randomization factor) CMH test p-value.|Cochran-Mantel-Haenszel|Stratified (randomization factor) CMH test.|95% CI for the difference in ORR was from Wilson's score method with continuity correction.|||42.1|23.2|<0.0001
91767710|NCT04194944|183424766|SUPERIORITY||Odds Ratio (OR)|1.7||||0.139|TWO_SIDED|95.0|0.9|3.6|||Cochran-Mantel-Haenszel|||||3.6|0.9|0.1390
91767711|NCT04194944|183424769|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0028|TWO_SIDED|95.0|1.4|5.1|||Cochran-Mantel-Haenszel|||||5.1|1.4|0.0028
91767712|NCT04194944|183424770|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0003|TWO_SIDED|95.0|1.6|5.2|||Cochran-Mantel-Haenszel|||||5.2|1.6|0.0003
91767713|NCT04194944|183424771|SUPERIORITY||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.224|0.633|||Log Rank|||||0.633|0.224|0.0001
91767714|NCT04194944|183424772|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.0004|TWO_SIDED|95.0|0.256|0.684|||Log Rank|||||0.684|0.256|0.0004
91767715|NCT04194944|183424775|SUPERIORITY||Odds Ratio (OR)|3.2||||0.1809|TWO_SIDED|95.0|0.8|12.8|||Cochran-Mantel-Haenszel|||||12.8|0.8|0.1809
91554045|NCT03391466|182995606|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.73||||0.027|TWO_SIDED|95.0|0.53|1.007||Stratified log-rank (randomization factor) p-value.|Log Rank|Stratified (randomization factor) log-rank test.|Stratified Cox regression models were used to estimate hazard ratio and 2-sided CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.||The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.|1.007|0.530|0.027
91554046|NCT03391466|182995607|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.736||||0.0695|TWO_SIDED|95.0|0.488|1.108||Stratified (randomization stratification factors) log-rank test.|Log Rank||Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care.|||1.108|0.488|0.0695
91554047|NCT03391466|182995608|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.29|0.487||One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.|||0.487|0.290|<0.0001
91554048|NCT03391466|182995609|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.327|0.545|||||Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.|||0.545|0.327|
91554049|NCT03391466|182995610|SUPERIORITY||Hazard Ratio (HR)|0.506|||||TWO_SIDED|95.0|0.383|0.669|||||Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.|||0.669|0.383|
91554050|NCT03391466|182995611|SUPERIORITY||Hazard Ratio (HR)|0.412|||||TWO_SIDED|95.0|0.318|0.532|||||Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.|||0.532|0.318|
91767716|NCT04194944|183424776|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0167|TWO_SIDED|95.0|1.4|19.6|||Cochran-Mantel-Haenszel|||||19.6|1.4|0.0167
91767717|NCT03400475|183424788|SUPERIORITY||Mean Difference (Final Values)|-2.088||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
91767718|NCT03400475|183424789|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
91767719|NCT03400475|183424790|SUPERIORITY||Mean Difference (Final Values)|3.596||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
91554051|NCT03391466|182995612|SUPERIORITY||Mixed Model with Repeated Measures|18.1|||<|0.0001|TWO_SIDED|95.0|12.3|23.9||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||23.9|12.3|<0.0001
91554052|NCT03391466|182995612|SUPERIORITY||Mixed Model with Repeated Measures|9.8||||0.0124|TWO_SIDED|95.0|2.6|17.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.0|2.6|0.0124
91767720|NCT03400475|183424791|SUPERIORITY||Mean Difference (Final Values)|-0.083||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
91767721|NCT03400475|183424792|SUPERIORITY||Mean Difference (Final Values)|0.581||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
91767722|NCT03400475|183424793|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
91767723|NCT03400475|183424794|SUPERIORITY||Mean Difference (Final Values)|-64.696||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
91767724|NCT03400475|183424795|SUPERIORITY||Mean Difference (Final Values)|111.03||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
91767725|NCT03400475|183424796|SUPERIORITY||Mean Difference (Final Values)|213.314||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
91554053|NCT03391466|182995612|SUPERIORITY||Mixed Model with Repeated Measures|4.4||||0.2655|TWO_SIDED|95.0|-3.3|12.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Month 9.||12.0|-3.3|0.2655
91554054|NCT03391466|182995613|SUPERIORITY||Mixed Model with Repeated Measures|13.1|||<|0.0001|TWO_SIDED|95.0|8.0|18.2||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||18.2|8.0|<0.0001
91554055|NCT03391466|182995613|SUPERIORITY||Mixed Model with Repeated Measures|5.1||||0.1253|TWO_SIDED|95.0|-0.9|11.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||11.0|-0.9|0.1253
91554056|NCT03391466|182995614|SUPERIORITY||Mixed Model with Repeated Measures|0.081||||0.0112|TWO_SIDED|95.0|0.024|0.138||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||0.138|0.024|0.0112
91554057|NCT03391466|182995614|SUPERIORITY||Mixed Model with Repeated Measures|0.028||||0.3703|TWO_SIDED|95.0|-0.034|0.091||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||0.091|-0.034|0.3703
91767726|NCT03400475|183424797|SUPERIORITY||Mean Difference (Final Values)|37.356||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
91767727|NCT03400475|183424798|SUPERIORITY||Mean Difference (Final Values)|1.6537||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
91767728|NCT03400475|183424799|SUPERIORITY||Mean Difference (Final Values)|1.552||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
91767729|NCT03400475|183424800|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
91767730|NCT03400475|183424801|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
91554058|NCT03391466|182995615|SUPERIORITY||Mixed Model with Repeated Measures|13.7|||<|0.0001|TWO_SIDED|95.0|8.5|18.8||False Discovery Rate Methodology|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Day 100.||18.8|8.5|<0.0001
91554059|NCT03391466|182995615|SUPERIORITY||Mixed Model with Repeated Measures|11.3||||0.0004|TWO_SIDED|95.0|5.4|17.1||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.1|5.4|0.0004
91554060|NCT03391466|182995615|SUPERIORITY||Mixed Model with Repeated Measures|3.8||||0.2549|TWO_SIDED|95.0|-2.3|10.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Month 9.||10.0|-2.3|0.2549
91554061|NCT00220805|182995626|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0|||||ANOVA|||The primary efficacy comparison for the change in LogMAR from baseline to endpoint was a two-way analysis of variance (ANOVA) with treatment group and center as fixed factors (main effect model).||||0.49
91554062|NCT00220805|182995627|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|||||Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|Cochran-Mantel-Haenszel|||||||0.76
91767731|NCT03400475|183424802|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91767732|NCT03400475|183424803|SUPERIORITY|||||||0.062|||||||Fisher Exact|||||||0.062
91767733|NCT03400475|183424804|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
91767734|NCT03400475|183424805|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
91554063|NCT00220805|182995628|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)||||||0.13
91554064|NCT00220805|182995629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED|95.0|-0.21|0.19|||ANOVA|||||0.19|-0.21|0.90
91767735|NCT04290039|183424829|OTHER|Estimation only|Geometric ratio of least-square means|0.579|||||TWO_SIDED|90.0|0.5265|0.636|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6360|0.5265|
91767736|NCT04290039|183424829|OTHER|Estimation only|Geometric ratio of least-square means|0.349|||||TWO_SIDED|90.0|0.3171|0.3839|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3839|0.3171|
91554065|NCT00220805|182995631|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted to centers||||||0.74
91554066|NCT03373916|182995640|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
91554067|NCT03373916|182995641|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91554068|NCT03373916|182995642|OTHER|||||||0.18|||||||Chi-squared|||||||0.18
91554069|NCT03373916|182995643|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91554070|NCT03373916|182995644|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
91554071|NCT01260896|182995693|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.84|||||TWO_SIDED|90.0|100.54|113.54|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.54|100.54|
91554072|NCT01260896|182995694|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.34|||||TWO_SIDED|90.0|100.37|110.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.55|100.37|
91554073|NCT01260896|182995695|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.12|||||TWO_SIDED|90.0|97.8|108.73|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.73|97.80|
91554074|NCT01260896|182995696|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|114.21|||||TWO_SIDED|90.0|109.29|119.35|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||119.35|109.29|
91767737|NCT04290039|183424829|OTHER|Estimation only|Geometric ratio of least-square means|0.603|||||TWO_SIDED|90.0|0.5524|0.6582|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6582|0.5524|
91554075|NCT01260896|182995697|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|108.26|||||TWO_SIDED|90.0|104.84|111.79|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.79|104.84|
91554076|NCT01260896|182995698|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.75|||||TWO_SIDED|90.0|92.92|102.85|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.85|92.92|
91554077|NCT00003222|182995724|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.13
91554078|NCT00003222|182995725|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.004
91554079|NCT02879318|182995811|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.72|TWO_SIDED|90.0|0.71|1.25||a priori threshold for statistical significance was 0.1.|Log Rank|stratified by ECOG performance status and prior adjuvant therapy.||||1.25|0.71|0.72
91554080|NCT02879318|182995812|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.91|TWO_SIDED|90.0|0.75|1.29|||Log Rank|||||1.29|0.75|0.91
91554081|NCT02879318|182995813|SUPERIORITY||Odds Ratio (OR)|1.49||||0.28|TWO_SIDED|90.0|0.81|2.72|||Cochran-Mantel-Haenszel|stratified by ECOG performance status and prior adjuvant chemotherapy||||2.72|0.81|0.28
91767738|NCT04290039|183424830|OTHER|Estimation only|Geometric ratio of least-square means|0.546|||||TWO_SIDED|90.0|0.4971|0.6004|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6004|0.4971|
91554082|NCT02382003|182995814|SUPERIORITY||Mean Difference (Net)|10.73||||0.005|TWO_SIDED|||||=Positive\~No-training, 0.030=Positive\~50/50 training, 0.833=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 7.053=Positive\~50/50 training, 0.366=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.005
91554083|NCT02382003|182995814|SUPERIORITY||Mean Difference (Net)|0.449||||0.799|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.799
91767739|NCT04290039|183424830|OTHER|Estimation only|Geometric ratio of least-square means|0.306|||||TWO_SIDED|90.0|0.2788|0.3367|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3367|0.2788|
91767740|NCT04290039|183424830|OTHER|Estimation only|Geometric ratio of least-square means|0.561|||||TWO_SIDED|90.0|0.5104|0.6164|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6164|0.5104|
91767741|NCT04290039|183424831|OTHER|Estimation only|Geometric ratio of least-square means|0.549|||||TWO_SIDED|90.0|0.4273|0.7118|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.7118|0.4273|
91554084|NCT02382003|182995814|SUPERIORITY||Mean Difference (Net)|9.085||||0.011|TWO_SIDED|||||=No-train+Neut\~Pos+Anx, 0.026=No-train+Neut\~Pos+Neut, 0.094=No-train+Anx\~Pos+Anx, 0.170=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≥ 0.136|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx, 7.328=No-train+Neut\~Pos+Neut, 4.722=No-train+Anx\~Pos+Anx, 3.547=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≤3.988|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.011
91554085|NCT02382003|182995815|SUPERIORITY||Mean Difference (Net)|11.551||||0.003|TWO_SIDED|||||"=Positive\~No-training, 0.130=Positive\~50/50 training, 0.269=50/50\~No-training~Alpha = .05"|Likelihood Ratio Tests|2=Positive\~No-training, 2=Positive\~50/50 training, 2=50/50\~No-training|=Positive\~No-training, 4.075=Positive\~50/50 training, 2.630=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.003
91554086|NCT02382003|182995815|SUPERIORITY||Mean Difference (Net)|3.933||||0.14|TWO_SIDED|||||Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime||Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.140
91554087|NCT02382003|182995815|SUPERIORITY||Mean Difference (Net)|6.018||||0.049|TWO_SIDED|||||=No-train+Neut\~Pos+Anx,0.049=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≥0.198,50/50(all)\~No-train+Anx≥0.104,0.014=No-train+Neut\~50/50+Neut,0.627=No-train+Neut\~50/50+Anx,0.021=Pos+Anx\~50/50+Anx,0.764=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≥0.067|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx,6.041=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≤3.240,50/50(all)\~No-train+Anx≤4.534,8.525=No-train+Neut\~50/50+Neut,0.933=No-train+Neut\~50/50+Anx,7.686=Pos+Anx\~50/50+Anx,0.537=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≤5.395|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.049
91554088|NCT02382003|182995816|SUPERIORITY||Mean Difference (Net)|17.42|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\<0.001, 0.124=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 31.921=Positive\~50/50 training, 4.175=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
91554089|NCT02382003|182995816|SUPERIORITY||Mean Difference (Net)|0.634||||0.728|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.728
91554090|NCT02382003|182995816|SUPERIORITY||Mean Difference (Net)|15.034|||<|0.001|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, 0.026=Pos+Anx\~No-train+Anx, 0.002=Pos+Neut\~No-train+Neut, 0.091=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≥ 0.081, Positive(all)\~50/50(all)\< 0.001|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 7.306=Pos+Anx\~No-train+Anx, 12.672=Pos+Neut\~No-train+Neut, 4.802=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≤5.037, Positive(all)\~50/50(all)≥16.239|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
91554091|NCT02382003|182995817|SUPERIORITY||Mean Difference (Net)|13.924|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\< 0.001, 0.100=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 15.288=Positive\~50/50 training, 4.605=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||< 0.001
91554092|NCT02382003|182995817|SUPERIORITY||Mean Difference (Net)|4.011||||0.135|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.135
91554093|NCT02382003|182995817|SUPERIORITY||Mean Difference (Net)|9.402||||0.009|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, Pos+Anx\~No-train+Anx\<0.048, Pos+Neut\~No-train+Neut\<0.001, 0.055=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≥0.139, 0.034=No-train+Neut\~50/50+Neut, 0.340=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≥ 0.087|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 6.076=Pos+Anx\~No-train+Anx, 14.525=Pos+Neut\~No-train+Neut, 5.811=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≤3.950, 6.770=No-train+Neut\~50/50+Neut, 2.158=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≤4.876|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.009
91554094|NCT05934292|182995822|OTHER||Geometric Mean Ratio|1.5|||||TWO_SIDED|90.0|0.98|2.31|||||Geometric mean ratio (GMR) and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.31|0.98|
91554095|NCT05934292|182995822|OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|0.74|1.74|||Geometric Mean Ratio||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.74|0.74|
91554096|NCT05934292|182995822|OTHER||Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.1|2.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.78|1.10|
91554097|NCT05934292|182995822|OTHER||Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.77|1.77|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.77|0.77|
91554098|NCT05934292|182995823|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.05|2.46|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.46|1.05|
91554099|NCT05934292|182995823|OTHER||Geometric Mean ratio|0.79|||||TWO_SIDED|90.0|0.37|1.72|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.72|0.37|
91554100|NCT05934292|182995823|OTHER||Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|0.8|2.54|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.54|0.80|
91554101|NCT05934292|182995823|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.78|0.78|
91767742|NCT04290039|183424831|OTHER|Estimation only|Geometric ratio of least-square means|0.049|||||TWO_SIDED|90.0|0.0381|0.0641|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.0641|0.0381|
91554102|NCT05934292|182995824|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.71|1.37|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls.|||1.37|0.71|
91554103|NCT05934292|182995824|OTHER||Geometric Mean Ratio|0.6|||||TWO_SIDED|90.0|0.34|1.04|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls.|||1.04|0.34|
91554104|NCT05934292|182995824|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.64|1.27|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls.|||1.27|0.64|
91554105|NCT05934292|182995824|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls.|||1.78|0.78|
91554106|NCT05934292|182995827|OTHER||Geometric Mean Ratio|0.67|||||TWO_SIDED|90.0|0.43|1.02|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.02|0.43|
91554107|NCT05934292|182995827|OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.58|1.35|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.35|0.58|
91554108|NCT05934292|182995827|OTHER||Geomtric Mean ratio|0.57|||||TWO_SIDED|90.0|0.36|0.91|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.91|0.36|
91767743|NCT04290039|183424831|OTHER|Estimation only|Geometric ratio of least-square means|0.09|||||TWO_SIDED|90.0|0.0695|0.1167|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.1167|0.0695|
91767744|NCT03096834|183424866|SUPERIORITY||Odds Ratio (OR)|2.73||||0.002|TWO_SIDED|95.0|1.43|5.19|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response (NRI).||||5.19|1.43|0.002
91554109|NCT05934292|182995827|OTHER||Geomtric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.57|1.29|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.29|0.57|
91554110|NCT05934292|182995828|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.67|0.83|
91767745|NCT03096834|183424867|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|0.55||0.004|TWO_SIDED|95.0|-2.67|-0.51|||Mixed Models Analysis|||Month 3||-0.51|-2.67|0.004
91767746|NCT03096834|183424868|SUPERIORITY||Mean Difference (Final Values)|-3.46|STANDARD_ERROR_OF_MEAN|1.13||0.003|TWO_SIDED|95.0|-5.7|-1.23|||Mixed Models Analysis|||Physical impairment domain||-1.23|-5.70|0.003
91767747|NCT03096834|183424868|SUPERIORITY||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.12|-1.7|||Mixed Models Analysis|||Everyday activities domain||-1.70|-6.12|<0.001
91767748|NCT03096834|183424869|SUPERIORITY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.43|-0.99|||Mixed Models Analysis|||||-0.99|-2.43|<0.001
91767749|NCT03096834|183424870|SUPERIORITY||Odds Ratio (OR)|3.16||||0.025|TWO_SIDED|95.0|1.11|9.01|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response||||9.01|1.11|0.025
91767750|NCT01600326|183424875|OTHER|Pair-wise comparison at Time point 1 compared to baseline|||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|See comments on P value||||||<0.0001
91767751|NCT01600326|183424875|SUPERIORITY||||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison||||<0.0001
91767752|NCT01600326|183424876|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>.99
91767753|NCT02849418|183424880|OTHER||Mean Difference (Net)|-3.02|||||TWO_SIDED|95.0|-5.85|-0.19|||||The analysis method was mixed-model for repeated measures (MMRM) with treatment, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|||-0.19|-5.85|
91767754|NCT01169103|183424967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||95.0|||||t-test, 2 sided|||We assumed that mean decrease in visceral fat in our population would be 0.85\*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.||||0.70
91554111|NCT05934292|182995828|OTHER||Geometric Mean ratio|1.08|||||TWO_SIDED|90.0|0.78|1.5|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.50|0.78|
91554112|NCT05934292|182995828|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.5|0.89|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.89|0.50|
91554113|NCT05934292|182995828|OTHER||Geometric Mean Ratio|1.4|||||TWO_SIDED|90.0|1.0|1.97|||||GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.97|1.00|
91767755|NCT01169103|183424967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||t-test, 2 sided|||Change in SAT p-value||||0.30
91767756|NCT01169103|183424968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.93
91767757|NCT01169103|183424969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||t-test, 2 sided|||Change in Total Cholesterol p-value||||0.03
91767758|NCT01169103|183424969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Change in Triglyceride p-value||||0.57
91767759|NCT01169103|183424969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||t-test, 2 sided|||Change in Low-density lipoprotein p-value||||0.062
91767760|NCT01169103|183424969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||t-test, 2 sided|||Change in High-density lipoprotein p-value||||0.0396
91767761|NCT01169103|183424970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 2 sided|||||||0.58
91767762|NCT01169103|183424971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
91767763|NCT00657046|183424992|SUPERIORITY_OR_OTHER|||||||0.693|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.693
91767764|NCT00657046|183424992|SUPERIORITY_OR_OTHER|||||||0.807|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.807
91767765|NCT00657046|183424993|SUPERIORITY_OR_OTHER|||||||0.212|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.212
91767766|NCT00657046|183424993|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.230
91767767|NCT00657046|183424994|SUPERIORITY_OR_OTHER|||||||0.712|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.712
91767768|NCT00657046|183424994|SUPERIORITY_OR_OTHER|||||||0.607|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.607
91767769|NCT00657046|183424995|SUPERIORITY_OR_OTHER|||||||0.4602|||||||ANCOVA|GLM model with baseline as a covariate||||||0.4602
91767770|NCT00657046|183424995|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|GLM model with baseline as a covariate||||||0.940
91767771|NCT00657046|183424996|SUPERIORITY_OR_OTHER|||||||0.376|||||||ANCOVA|GLM model with baseline as a covariate||||||0.376
91767772|NCT00657046|183424996|SUPERIORITY_OR_OTHER|||||||0.903|||||||ANCOVA|GLM model with baseline as a covariate||||||0.903
91767773|NCT00657046|183424997|SUPERIORITY_OR_OTHER|||||||0.319|||||||ANCOVA|GLM model with baseline as a covariate||||||0.319
91767774|NCT00657046|183424997|SUPERIORITY_OR_OTHER|||||||0.408|||||||ANCOVA|GLM model with baseline as a covariate||||||0.408
91767775|NCT00657046|183424998|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|GLM model with baseline as a covariate||||||0.004
91767776|NCT00657046|183424998|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|GLM model with baseline as a covariate||||||0.030
91554114|NCT05934292|182995833|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
91554115|NCT05934292|182995833|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
91554116|NCT05934292|182995834|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
91554117|NCT05934292|182995834|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
91554118|NCT05934292|182995835|OTHER||Geometric Mean Ratio|0.29|||||TWO_SIDED|90.0|0.16|0.55|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.55|0.16|
91554119|NCT05934292|182995835|OTHER||Geometric Mean Ratio|0.14|||||TWO_SIDED|90.0|0.06|0.36|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.36|0.06|
91554120|NCT05714059|182995843|NON_INFERIORITY|The overall mean change in HbA1c, from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
91554121|NCT05714059|182995843|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 0.4%. A significance level of 0.025 (one-sided) was used|Mean difference from baseline to exit|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.6|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.6|-0.8|<0.001
91767777|NCT00657046|183424999|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|GLM model with baseline as a covariate||||||0.025
91767778|NCT00657046|183424999|SUPERIORITY_OR_OTHER|||||||0.022|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.022
91767779|NCT00657046|183425000|SUPERIORITY_OR_OTHER|||||||0.082|||||||Fisher Exact|||||||0.082
91554122|NCT05714059|182995844|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 65.3% with a margin of 7.5%.|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
91554123|NCT05714059|182995844|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 73.7% with a margin of 7.5%.|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
91554124|NCT05714059|182995845|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.71% with a margin of 2%.|Mean value (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from last 6-7 weeks of 3 month study period was estimated for this endpoint.|||0.4|0.3|<0.001
91554125|NCT05714059|182995845|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.86% with a margin of 2%.|Mean value (Final Values)|0.2|||<|0.001|TWO_SIDED|95.0|0.1|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) were summarized from last 6-7 weeks of 3 month study period for this endpoint|||0.3|0.1|<0.001
91554126|NCT05714059|182995846|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 65.3% by a simple superiority test|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
91554127|NCT05714059|182995846|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 73.7% by a simple superiority test|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
91767780|NCT00657046|183425000|SUPERIORITY_OR_OTHER|||||||0.008|||||||Fisher Exact|||||||0.008
91767781|NCT03827655|183425001|SUPERIORITY||Hazard Ratio (HR)|0.92|||=|0.649|TWO_SIDED|90.0|0.63|1.33||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% confidence intervals (CIs) and associated Wald Chi-square p-values between TAK-954 dose levels and placebo were obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.33|0.63|=0.649
91767782|NCT03827655|183425001|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.505|TWO_SIDED|90.0|0.69|1.43||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.43|0.69|=0.505
91767783|NCT03827655|183425002|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.449|TWO_SIDED|90.0|0.71|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.71|=0.449
91554128|NCT04899674|182995847|OTHER||Ratio of gMeans [%]|94.6|||||TWO_SIDED|90.0|86.3|103.8|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone). Intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.8|86.3|
91554129|NCT04899674|182995848|OTHER||Ratio of gMeans[%]|90.7|||||TWO_SIDED|90.0|74.3|110.7|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Intra-individual geometric coefficient of variation (gCV \[%\])=31.5."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||110.7|74.3|
91554130|NCT04899674|182995849|OTHER||Ratio of gMeans [%]|95.1|||||TWO_SIDED|90.0|86.7|104.3|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA). The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||104.3|86.7|
91554131|NCT02379351|182995853|OTHER|This pilot study is primarily descriptive statistics||||||0.1|||||||Chi-squared|Data analysis will use mostly descriptive statistics - parametric and nonparametric statistics will be used as indicated (Chi-squared)||||||.1
91554132|NCT02379351|182995854|NON_INFERIORITY|Likert Scale of Provider Satisfaction|||||<|0.01|||||||Chi-squared|Data analysis will use mostly descriptive statistics: parametric and nonparametric statistics will be used as indicated.|||Likert Scale of Provider Satisfaction|||<0.01
91554133|NCT01617369|182995882|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists||||<.05
91554134|NCT00945321|182995891|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.93||||0.001|TWO_SIDED|95.0|0.84|1.02||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.02|0.84|0.001
91554135|NCT00945321|182995891|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.96|1.15||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.15|0.96|<0.001
91554136|NCT00945321|182995891|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.47|||||TWO_SIDED|90.0|1.23|1.76||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.76|1.23|
91554137|NCT00945321|182995891|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.08|||||TWO_SIDED|90.0|0.88|1.32||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.32|0.88|
91554138|NCT00945321|182995891|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.22|||||TWO_SIDED|90.0|1.01|1.46||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.46|1.01|
91554139|NCT00945321|182995891|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.43|||||TWO_SIDED|90.0|1.16|1.75||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.75|1.16|
91554140|NCT00945321|182995892|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.56|1.13|
91554141|NCT00945321|182995892|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.86|1.25||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.25|0.86|
91554142|NCT00945321|182995892|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.14|||||TWO_SIDED|90.0|0.96|1.34||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.34|0.96|
91554143|NCT00945321|182995892|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.4|||||TWO_SIDED|90.0|1.16|1.68||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.68|1.16|
91554144|NCT02438137|182995893|SUPERIORITY|In multiple linear regression models, the effect of DMF treatment on mean RDI change (beta-coefficient) was -11.3 respiratory events per hour (p=0.0124).|beta-coefficient for treatment effect|-11.3|STANDARD_ERROR_OF_MEAN|4.3||0.0124|TWO_SIDED||||||Regression, Linear|||Multiple linear regression models were used to calculate treatment effect (DMF or placebo) on mean RDI change, controlling for change in age, gender, BMI, time spent in supine sleep, and time spent in REM sleep.|A mixed effects model, which treated RDI as a repeated measure and used individual ID as random effect, adjusted for age, gender, BMI, time spent in supine sleep, was also conducted. In this model, the effect of DMF compared to placebo, controlling for all other covariates, is a 28% decrease in Month 4 RDI (p=0.033).|||0.0124
91554145|NCT00692913|182995895|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.2|||<|0.001||95.0|0.12|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.||||0.35|0.12|<0.001
91554146|NCT00692913|182995896|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-9.7|||<|0.001||95.0|-14.49|-4.93|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.93|-14.49|<0.001
91554147|NCT00692913|182995897|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-7.07|||<|0.001||95.0|-10.95|-3.2|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.20|-10.95|<0.001
91554148|NCT00692913|182995898|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.21|||<|0.001||95.0|0.13|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||0.35|0.13|<0.001
91554149|NCT00692913|182995899|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.01||||0.047||95.0|0.01|2.0|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.|||2.00|0.01|0.047
91554150|NCT00692913|182995899|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.82||||0.035||95.0|0.06|1.58|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Total Hip.|||1.58|0.06|0.035
91554151|NCT00692913|182995900|SUPERIORITY_OR_OTHER_LEGACY||Difference of falls (falls/patient-year)|0.03|STANDARD_ERROR_OF_MEAN|0.08||0.675||95.0|-0.12|0.19|||Zero-Inflated Poisson Regression|Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).||||0.19|-0.12|0.675
91554152|NCT00692913|182995901|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.35||||0.001||95.0|-13.19|-3.54|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.54|-13.19|0.001
91554153|NCT00692913|182995902|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.07|||<|0.001||95.0|-11.94|-4.21|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.21|-11.94|<0.001
91767784|NCT03827655|183425002|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.507|TWO_SIDED|90.0|0.69|1.44||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.44|0.69|=0.507
91554154|NCT00195403|182995956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in PGA at Month 3 was evaluated using paired t-test.||||<0.0001
91554155|NCT00195403|182995957|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.||||<0.0001
91554156|NCT05288348|182995968|SUPERIORITY||Mean Difference (Final Values)|2.57||||0.56|TWO_SIDED|95.0|-6.19|11.33||unadjusted|Mixed Models Analysis|Mixed methods ANOVA||||11.33|-6.19|0.56
91554157|NCT05288348|182995968|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.92|TWO_SIDED|95.0|-10.5|9.48|||Mixed Models Analysis|Mixed methods ANOVA||Adjusted for age, sex, respiratory rate and injury type||9.48|-10.5|0.92
91554158|NCT05288348|182995969|SUPERIORITY||Mean Difference (Final Values)|-7.14||||0.18|TWO_SIDED|95.0|-17.66|3.37|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60min||3.37|-17.66|0.18
91554159|NCT05288348|182995969|SUPERIORITY||Median Difference (Final Values)|2.92||||0.63|TWO_SIDED|95.0|-9.3|15.1|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60 min Adjusted for sex and injury type||15.10|-9.30|0.63
91554160|NCT05288348|182995969|SUPERIORITY||Mean Difference (Final Values)|-10.59||||0.08|TWO_SIDED|95.0|-22.39|1.21||Unadjusted|Mixed Models Analysis|||VNRS @ 90 min||1.21|-22.39|0.08
91554161|NCT05288348|182995969|SUPERIORITY||Mean Difference (Final Values)|7.36||||0.28|TWO_SIDED|95.0|-6.13|20.8|||Mixed Models Analysis|Mixed Method ANOVA|Adjusted for ISS|VNRS @90min adjusted||20.80|-6.13|0.28
91554162|NCT05288348|182995969|SUPERIORITY||Mean Difference (Final Values)|-9.52||||0.18|TWO_SIDED|95.0|-23.6|4.56|||Mixed Models Analysis|||VNRS @ 120 min||4.56|-23.60|0.18
91554163|NCT05288348|182995969|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.5|TWO_SIDED|95.0|-20.7|10.2|||Mixed Models Analysis|Mixed Method ANOVA||VNRS @ 120min adjusted for sex, HR, RR, and injury type||10.20|-20.70|0.50
91554164|NCT05288348|182995970|SUPERIORITY|||||||0.005||||||PGA @ 30 min|Chi-squared|||||||0.005
91554165|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|1.45||||0.39|TWO_SIDED|95.0|-4.77|1.89|||General Addative Model|||"SPID 30~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||1.89|-4.77|0.39
91767785|NCT03827655|183425003|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.406|TWO_SIDED|90.0|0.73|1.52||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.52|0.73|=0.406
91554166|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|1.72||||0.29|TWO_SIDED|95.0|-1.5|4.95|||General Additive Model|||"SPID 30, Adjusted Analysis~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||4.95|-1.50|0.29
91554167|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|0.08||||0.98|TWO_SIDED|95.0|-6.63|6.47|||Generalized Additive Model|||SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||6.47|-6.63|0.98
91554168|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|0.61||||0.85|TWO_SIDED|95.0|-5.76|6.98|||Generalized Additive Model|||"SPID 60 Adjusted~Last observed carried forward to address missingness"||6.98|-5.76|0.85
91554169|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|-1.26||||0.8|TWO_SIDED|95.0|-8.75|11.28|||Generalized Additive Model|||SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||11.28|-8.75|0.8
91554170|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|-0.44||||0.92|TWO_SIDED|95.0|-10.2|9.92|||Generalized Additive Model|||"SPID 90 min Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||9.92|-10.2|0.92
91554171|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|-3.18||||0.64|TWO_SIDED|95.0|-10.45|16.9|||Generalized Additive Model|||SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||16.90|-10.45|0.64
91554172|NCT05288348|182995971|SUPERIORITY||Odds Ratio (OR)|-2.15||||0.75|TWO_SIDED|95.0|-15.6|11.3|||Generalized Additive Model|||"SPID 120 Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||11.30|-15.60|0.75
91554173|NCT05288348|182995972|SUPERIORITY||z statistic|0.46||||0.64|TWO_SIDED|95.0|-1.96|1.96|||two sided test of proportion|||||1.96|-1.96|0.64
91554174|NCT05288348|182995973|SUPERIORITY||Odds Ratio (OR)|-0.22||||0.61|TWO_SIDED|95.0|-1.11|0.66|||General Additive Models|||||0.66|-1.11|0.61
91554175|NCT05288348|182995973|SUPERIORITY||Odds Ratio (OR)|-0.28||||0.54|TWO_SIDED|95.0|-1.23|0.65|||General Additive Model|||6 item screener adjusted analysis||0.65|-1.23|0.54
91554176|NCT05288348|182995974|SUPERIORITY||Odds Ratio (OR)|2.35||||0.009|TWO_SIDED|95.0|1.24|4.46|||Ordinal Polytomous Logisitic Regression|||Healthcare Professional Global Assessment of method of pain control at 30 min.||4.46|1.24|0.009
91554177|NCT05288348|182995974|SUPERIORITY||Odds Ratio (OR)|2.24||||0.01|TWO_SIDED|95.0|1.18|4.29|||Ordinal polytomous logistic regression|||Healthcare Professional Global Assessment of method of pain control at 30 min. adjusted for ISS and Race||4.29|1.18|0.01
91554178|NCT05288348|182995975|SUPERIORITY||Odds Ratio (OR)|0.97||||0.96|TWO_SIDED|95.0|0.22|4.26|||Regression, Logistic|||||4.26|0.22|0.96
91554179|NCT05288348|182995975|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.17|5.04|||||Adjusted for age, sex and SpO2|||5.04|0.17|
91554180|NCT05288348|182995976|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.04|24.92||||||||24.92|0.04|
91554181|NCT05288348|182995976|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.0|14.28|||||Adjusted for Heart Rate and Injury Severity Score|||14.28|0|
91554182|NCT05288348|182995977|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|0.39|8.37||||||||8.37|0.39|
91554183|NCT05288348|182995977|SUPERIORITY||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.39|8.6|||||Adjusted for SpO2|||8.60|0.39|
91554184|NCT05288348|182995979|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.02|5.12||||||||5.12|0.02|
91554185|NCT05288348|182995979|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.02|4.56|||||Adjusted for heart rate|||4.56|0.02|
91554186|NCT05288348|182995980|SUPERIORITY||difference of proportion|0.135|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
91554187|NCT05288348|182995981|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED|95.0|0.69|1.61|||Regression, Cox|||||1.61|0.69|0.90
91554188|NCT05288348|182995981|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.48|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||Adjusted for Race and ISS||1.81|0.75|0.48
91554189|NCT05288348|182995983|SUPERIORITY||Odds Ratio (OR)|0.0||||0.99|TWO_SIDED|95.0|-0.15|0.15|||Non parametric General Addative Model|||||0.15|-0.15|0.99
91554190|NCT05288348|182995983|SUPERIORITY||Odds Ratio (OR)|0.01||||0.96|TWO_SIDED|95.0|-0.16|0.15|||Non Parametric General Additive Model|||Adjusted||0.15|-0.16|0.96
91554191|NCT05288348|182995984|SUPERIORITY||Odds Ratio (OR)|0.01||||0.84|TWO_SIDED|95.0|-0.17|0.16|||Non Parametric General Additive Model|||||0.16|-0.17|0.84
91554192|NCT05288348|182995984|SUPERIORITY||Odds Ratio (OR)|0.02||||0.84|TWO_SIDED|95.0|-0.19|0.16|||Non Parametric Generalized Additive Mode|||Adjusted||0.16|-0.19|0.84
91554193|NCT05288348|182995985|SUPERIORITY||Odds Ratio (OR)|0.02||||0.81|TWO_SIDED|95.0|-0.17|0.22|||Non Parametric Generalized Additive Mode|||||0.22|-0.17|0.81
91554194|NCT05288348|182995985|SUPERIORITY||Odds Ratio (OR)|0.01||||0.91|TWO_SIDED|95.0|-0.2|0.22|||Non Parametric Generalized Additive Mode|||Adjusted||0.22|-0.20|0.91
91554195|NCT05288348|182995986|SUPERIORITY||Odds Ratio (OR)|0.03||||0.74|TWO_SIDED|95.0|-0.25|0.18|||Non Parametric Generalized Additive Mode|||||0.18|-0.25|0.74
91554196|NCT05288348|182995986|SUPERIORITY||Odds Ratio (OR)|0.05||||0.63|TWO_SIDED|95.0|-0.3|0.18|||Non Parametric Generalized Additive Mode|||Adjusted||0.18|-0.30|0.63
91554197|NCT04121741|182996052|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.42||0.864|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing video intervention compared to control) is shown. Estimates of FMD% for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.864
91767786|NCT03827655|183425003|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.88|TWO_SIDED|90.0|0.54|1.11||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.11|0.54|=0.880
91554198|NCT04121741|182996052|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.42||0.913|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing coach intervention compared to control) is shown. Estimates of FMD% for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.913
91554199|NCT04121741|182996053|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.29|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing video intervention compared to control) is shown. Estimates of RHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.290
91554200|NCT04121741|182996053|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.462|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing coach intervention compared to control) is shown. Estimates of RHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.462
91554201|NCT04121741|182996054|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing video intervention compared to control) is shown. Estimates of fRHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.005
91554202|NCT04121741|182996054|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.18||0.57|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing coach intervention compared to control) is shown. Estimates of fRHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.570
91554203|NCT01084863|182996069|EQUIVALENCE|Pharmacokinetic equivalence was predefined based on acceptance criteria, 80% to 125%.|Geometric Mean Ratio|104.57|||||TWO_SIDED|90.0|93.64|116.78||||||||116.78|93.64|
91554204|NCT03593356|182996118|SUPERIORITY||Slope|-0.427|STANDARD_ERROR_OF_MEAN|1.179||0.717|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.717
91554205|NCT03593356|182996121|SUPERIORITY||Slope|-0.012|STANDARD_ERROR_OF_MEAN|0.043||0.784|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.789.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.784
91554206|NCT03593356|182996122|SUPERIORITY||Slope|0.578|STANDARD_ERROR_OF_MEAN|0.807||0.474|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.474
91554207|NCT03593356|182996129|SUPERIORITY||Slope|0.234|STANDARD_ERROR_OF_MEAN|0.882||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.791.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
91554208|NCT03593356|182996130|SUPERIORITY||Slope|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.646.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
91554209|NCT03593356|182996131|SUPERIORITY||Slope|0.139|STANDARD_ERROR_OF_MEAN|0.86||0.872|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.872
91554210|NCT03593356|182996134|SUPERIORITY||Slope|0.133|STANDARD_ERROR_OF_MEAN|0.1||0.184|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.184
91554211|NCT03593356|182996137|SUPERIORITY||Slope|0.138|STANDARD_ERROR_OF_MEAN|0.173||0.415|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.427.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.415
91554212|NCT03593356|182996138|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.14||0.567|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.541.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.567
91554213|NCT04977583|182996429|SUPERIORITY||Odds Ratio (OR)|1.138|STANDARD_ERROR_OF_MEAN|0.2625||0.6243|TWO_SIDED|95.0|0.679|1.904|||Mixed Models Analysis|||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.904|0.679|0.6243
91554214|NCT04977583|182996429|SUPERIORITY||Odds Ratio (OR)|1.497|STANDARD_ERROR_OF_MEAN|0.2553||0.1146|TWO_SIDED|95.0|0.908|2.469|||Mixed Models Analysis|||This test compares Arm 1 (screening) to arm 3 (assistance)||2.469|0.908|0.1146
91554215|NCT04977583|182996430|SUPERIORITY||Risk Ratio (RR)|0.963|STANDARD_ERROR_OF_MEAN|0.2078||0.856|TWO_SIDED|95.0|0.641|1.447|||Poisson|We used total needs as an offset||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.447|0.641|0.856
91554216|NCT04977583|182996430|SUPERIORITY||Risk Ratio (RR)|1.136|STANDARD_ERROR_OF_MEAN|0.1999||0.5248|TWO_SIDED|95.0|0.768|1.681|||Poisson|||This test is comparing Arm 1 (screening) to Arm 3 (assistance)||1.681|0.768|0.5248
91554217|NCT04977583|182996431|SUPERIORITY||Odds Ratio (OR)|0.866|STANDARD_ERROR_OF_MEAN|0.22||0.5582|TWO_SIDED|95.0|0.536|1.4|||Regression, Logistic|||This is Arm 1 compared to Arm 2||1.400|0.536|.5582
91554218|NCT04977583|182996431|SUPERIORITY||Odds Ratio (OR)|0.854|STANDARD_ERROR_OF_MEAN|0.217||0.5196|TWO_SIDED|95.0|0.528|1.381|||Regression, Logistic|||This is Arm 1 compared to Arm 3||1.381|0.528|0.5196
91554219|NCT04977583|182996432|SUPERIORITY||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.2794||0.2105|TWO_SIDED|95.0|0.821|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.821|0.2105
91554220|NCT04977583|182996432|SUPERIORITY||Odds Ratio (OR)|0.7944|STANDARD_ERROR_OF_MEAN|0.2816||0.4143|TWO_SIDED|95.0|0.4574|1.379|||ANOVA|||This is arm 1 compared to arm 3||1.379|0.4574|.4143
91554221|NCT04977583|182996433|SUPERIORITY||Odds Ratio (OR)|0.9995|STANDARD_ERROR_OF_MEAN|0.0171||0.9775|TWO_SIDED|95.0|0.9665|1.0336|||ANOVA|||This arm 1 compared to arm 2||1.0336|0.9665|0.9775
91554222|NCT04977583|182996433|SUPERIORITY||Odds Ratio (OR)|1.017|STANDARD_ERROR_OF_MEAN|0.0176||0.3194|TWO_SIDED|95.0|0.9832|1.0534|||ANOVA|||This arm 1 compared to arm 3||1.0534|0.9832|0.3194
91554223|NCT04977583|182996434|SUPERIORITY||Odds Ratio (OR)|1.0284|STANDARD_ERROR_OF_MEAN|0.1613||0.8623|TWO_SIDED|95.0|0.7497|1.4107|||ANOVA|||This is arm 1 compared to arm 2||1.4107|0.7497|0.8623
91554224|NCT04977583|182996434|SUPERIORITY||Odds Ratio (OR)|1.3701|STANDARD_ERROR_OF_MEAN|0.1626||0.0534|TWO_SIDED|95.0|0.9962|1.8844|||ANOVA|||This is arm 1 compared to arm 3||1.8844|0.9962|0.0534
91554225|NCT04977583|182996435|SUPERIORITY||Odds Ratio (OR)|2.298|STANDARD_ERROR_OF_MEAN|1.464||0.5701|TWO_SIDED|95.0|0.1304|40.5121|||ANOVA|||This is arm 1 compared to arm 2||40.5121|0.1304|0.5701
91554226|NCT04977583|182996435|SUPERIORITY||Odds Ratio (OR)|4.56|STANDARD_ERROR_OF_MEAN|1.467||0.3016|TWO_SIDED|95.0|0.2571|80.8746|||ANOVA|||This is arm 1 compared to arm 3||80.8746|0.2571|0.3016
91554227|NCT04977583|182996436|SUPERIORITY||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.2438||0.087|TWO_SIDED|95.0|0.944|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.944|0.0870
91554228|NCT04977583|182996436|SUPERIORITY||Odds Ratio (OR)|1.85|STANDARD_ERROR_OF_MEAN|0.2897||0.0354|TWO_SIDED|95.0|1.048|3.264|||ANOVA|||This is arm 1 compared to arm 3||3.264|1.048|0.0354
91554229|NCT04977583|182996437|SUPERIORITY||Odds Ratio (OR)|0.618|STANDARD_ERROR_OF_MEAN|0.333||0.3063|TWO_SIDED|95.0|0.246|1.553|||ANOVA|||This is arm 1 compared to arm 2||1.553|0.246|0.3063
91554230|NCT04977583|182996437|SUPERIORITY||Odds Ratio (OR)|0.679|STANDARD_ERROR_OF_MEAN|0.3946||0.4378|TWO_SIDED|95.0|0.256|1.803|||ANOVA|||This is arm 1 compared to arm 3||1.803|.256|.4378
91554231|NCT04977583|182996438|SUPERIORITY||Odds Ratio (OR)|0.5083|STANDARD_ERROR_OF_MEAN|0.8265||0.4134|TWO_SIDED|95.0|0.1006|2.5687|||ANOVA|||This is arm 1 compared to arm 2||2.5687|0.1006|0.4134
91554232|NCT04977583|182996438|SUPERIORITY||Odds Ratio (OR)|1.819|STANDARD_ERROR_OF_MEAN|0.8283||0.4705|TWO_SIDED|95.0|0.3588|9.223|||ANOVA|||This is arm 1 compared to arm 3||9.2230|0.3588|0.4705
91554233|NCT04977583|182996439|SUPERIORITY||Odds Ratio (OR)|1.765|STANDARD_ERROR_OF_MEAN|0.2684||0.0347|TWO_SIDED|95.0|1.044|2.987|||Mixed Models Analysis||This analysis is arm 1 compared to arm 3. Arm 3 is the numerator and arm 1 is the denominator.|||2.987|1.044|0.0347
91554234|NCT04977583|182996440|SUPERIORITY||Odds Ratio (OR)|1.734|STANDARD_ERROR_OF_MEAN|0.3489||0.116|TWO_SIDED|95.0|0.875|3.436|||Mixed Models Analysis||This analysis compares arm 1 to arm 2. Arm 2 is the numerator and Arm 1 is the denominator|||3.436|0.875|0.1160
91554235|NCT04977583|182996440|SUPERIORITY||Odds Ratio (OR)|2.376|STANDARD_ERROR_OF_MEAN|0.3475||0.0134|TWO_SIDED|95.0|1.202|4.695|||Mixed Models Analysis|||||4.695|1.202|0.0134
91554236|NCT04977583|182996441|SUPERIORITY||Odds Ratio (OR)|5.006|STANDARD_ERROR_OF_MEAN|0.617||0.0094|TWO_SIDED|95.0|1.512|16.57|||Mixed Models Analysis||This analysis is arm 1 compared to compared to arm 3. Arm 3 is the numerator and arm 1 is denominator.|||16.570|1.512|0.0094
91554237|NCT04977583|182996441|SUPERIORITY||Odds Ratio (OR)|1.875|STANDARD_ERROR_OF_MEAN|0.6532||0.3377|TWO_SIDED|95.0|0.521|6.746|||Mixed Models Analysis||This is a comparison of arm 1 and arm 2. Arm 2 is the numerator and arm 1 is the denominator.|||6.746|0.521|0.3377
91554238|NCT00979459|182996444|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the AUC(0 to infinity) geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|0.99||||||||0.99|0.86|
91554239|NCT00979459|182996445|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the Cmax geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|1.07|||||TWO_SIDED|90.0|0.92|1.24||||||||1.24|0.92|
91554240|NCT00786864|182996458|SUPERIORITY_OR_OTHER||||||p=|0||95.0|||||ANCOVA|||||||p=0.001
91554241|NCT00786864|182996459|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
91554242|NCT00786864|182996460|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
91554243|NCT00786864|182996461|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.01
91554244|NCT02422615|182996462|SUPERIORITY||Cox Proportional Hazard|0.593||||4.1e-07|TWO_SIDED|95.0|0.48|0.732|||Log Rank|||||0.732|0.480|0.00000041
91554245|NCT02422615|182996463|SUPERIORITY||Cox Proportional Hazard|0.724||||0.00455|TWO_SIDED|95.0|0.568|0.924|||Log Rank|||||0.924|0.568|0.00455
91554246|NCT02422615|182996464|SUPERIORITY||Cox Proportional Hazard|0.492|||||TWO_SIDED|95.0|0.345|0.703||||||||0.703|0.345|
91767787|NCT03827655|183425004|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.446|TWO_SIDED|90.0|0.72|1.48||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.48|0.72|=0.446
91767788|NCT03827655|183425004|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.892|TWO_SIDED|90.0|0.53|1.09||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.09|0.53|=0.892
91554247|NCT01288443|182996475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 100 mg Q2W versus placebo~4. Alirocumab 200 mg Q4W versus placebo~5. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level"||||<0.0001
91554248|NCT01288443|182996475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
91554249|NCT01288443|182996475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
91554250|NCT01288443|182996475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
91767789|NCT03827655|183425005|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.76|TWO_SIDED|90.0|0.6|1.23||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.23|0.60|=0.760
91767790|NCT03827655|183425005|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.81|TWO_SIDED|90.0|0.58|1.18||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-squared test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.18|0.58|=0.810
91554251|NCT01288443|182996475|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
91554252|NCT04327843|182996484|OTHER|This is a prospective study with a repeated measures design.||||||0.001||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed||||||0.001
91554253|NCT04327843|182996485|OTHER|This is a prospective study with a repeated measures design.||||||0.43||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.43
91554254|NCT04327843|182996486|OTHER|This is a prospective study with a repeated measures design.||||||0.07||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.07
91554255|NCT04327843|182996487|OTHER|This is a prospective study with a repeated measures design.||||||0.1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.10
91554256|NCT04327843|182996488|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
91554257|NCT04327843|182996489|OTHER|This is a prospective study with a repeated measures design.||||||1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||1.00
91554258|NCT04327843|182996491|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
91554259|NCT04327843|182996492|OTHER|This is a prospective study with a repeated measures design.||||||0.14||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.14
91554260|NCT03614663|182996522|SUPERIORITY|||||||0.321|||||||MMRM - Mixed model for repeated measures|||||||0.321
91554261|NCT03614663|182996523|SUPERIORITY|||||||0.149|||||||MMRM - Mixed model for repeated measures|||||||0.149
91554262|NCT03614663|182996524|SUPERIORITY|||||||0.607|||||||MMRM - Mixed model for repeated measures|||||||0.607
91554263|NCT03614663|182996525|SUPERIORITY|||||||0.426|||||||ANOVA|||||||0.426
91554264|NCT03614663|182996526|SUPERIORITY|||||||0.02|||||||MMRM - Mixed model for repeated measures|||||||0.02
91554265|NCT03614663|182996527|SUPERIORITY|||||||0.091|||||||MMRM - Mixed model for repeated measures|||||||0.091
91554266|NCT03614663|182996528|SUPERIORITY|||||||0.135|||||||MMRM - Mixed model for repeated measures|||||||0.135
91767791|NCT03827655|183425006|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.288|TWO_SIDED|90.0|0.78|1.64||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.64|0.78|=0.288
91767792|NCT03827655|183425006|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.453|TWO_SIDED|90.0|0.72|1.47||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.47|0.72|=0.453
91767793|NCT03827655|183425007|SUPERIORITY||Risk Difference (RD)|-0.09|||=|0.046|TWO_SIDED|90.0|-0.17|0.0||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.00|-0.17|=0.046
91554267|NCT03614663|182996529|SUPERIORITY|||||||0.056|||||||MMRM - Mixed model for repeated measures|||||||0.056
91554268|NCT05274321|182996534|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.22||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.22
91554269|NCT05274321|182996535|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval. .||||||0.02||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.02
91554270|NCT05274321|182996536|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.03||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.03
91554271|NCT05274321|182996537|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.25||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.25
91767794|NCT03827655|183425007|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.516|TWO_SIDED|90.0|-0.11|0.11||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.11|-0.11|=0.516
91554272|NCT01105975|182996562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.5|||<|0.001|TWO_SIDED|90.0|64.9|92.1|||mixed model repeated measures (MMRM)|||||92.1|64.9|<0.001
91554273|NCT01105975|182996563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.002|TWO_SIDED|90.0|-21.2|-6.7|||mixed model repeated measures (MMRM)|||||-6.7|-21.2|0.002
91554274|NCT01105975|182996564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|56.7|||<|0.001|TWO_SIDED|90.0|43.6|69.8|||mixed model repeated measures (MMRM)|||||69.8|43.6|<0.001
91554275|NCT01105975|182996564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.6|||<|0.001||90.0|84.5|110.8|||mixed model repeated measures (MMRM)|||||110.8|84.5|<0.001
91554276|NCT01105975|182996564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|131.9|||<|0.001|TWO_SIDED|90.0|118.5|145.2|||mixed model repeated measures (MMRM)|||||145.2|118.5|<0.001
91554277|NCT01105975|182996565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|90.0|-24.6|-10.5|||mixed model repeated measures (MMRM)|||||-10.5|-24.6|<0.001
91554278|NCT01105975|182996565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2|||<|0.001|TWO_SIDED|90.0|-33.2|-19.2|||mixed model repeated measures (MMRM)|||||-19.2|-33.2|<0.001
91554279|NCT01105975|182996565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.8|||<|0.001|TWO_SIDED|90.0|-47.0|-32.7|||mixed model repeated measures (MMRM)|||||-32.7|-47.0|<0.001
91554280|NCT01105975|182996566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.3|||<|0.001||90.0|66.2|92.4|||mixed model repeated measures (MMRM)|||||92.4|66.2|<0.001
91554281|NCT01105975|182996566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.5|||<|0.001|TWO_SIDED|90.0|75.2|101.8|||mixed model repeated measures (MMRM)|||||101.8|75.2|<0.001
91554282|NCT01105975|182996567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2||||0.009|TWO_SIDED|90.0|-18.3|-4.2|||mixed model repeated measures (MMRM)|||||-4.2|-18.3|0.009
91554283|NCT01105975|182996567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5||||0.002|TWO_SIDED|90.0|-20.6|-6.4|||mixed model repeated measures (MMRM)|||||-6.4|-20.6|0.002
91767795|NCT03827655|183425008|SUPERIORITY||Risk Difference (RD)|-0.03|||=|0.296|TWO_SIDED|90.0|-0.12|0.06||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.06|-0.12|=0.296
91767796|NCT03827655|183425008|SUPERIORITY||Risk Difference (RD)|0.03|||=|0.677|TWO_SIDED|90.0|-0.07|0.13||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.13|-0.07|=0.677
91767797|NCT03827655|183425009|SUPERIORITY||Hazard Ratio (HR)|1.1|||=|0.338|TWO_SIDED|90.0|0.76|1.57||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.57|0.76|=0.338
91767798|NCT03827655|183425009|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.422|TWO_SIDED|90.0|0.73|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.73|=0.422
91767799|NCT03318549|183425101|OTHER|||||||0.011|||||||t-test, 2 sided|||||||0.011
91767800|NCT03318549|183425101|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
91767801|NCT03318549|183425102|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
91767802|NCT03318549|183425105|OTHER|||||||0.132|||||||t-test, 2 sided|||||||0.132
91767803|NCT03318549|183425105|OTHER|||||||0.647|||||||t-test, 2 sided|||||||0.647
91767804|NCT00104650|183425109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.28|||<|0.001||95.0|3.35|45.03|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||45.03|3.35|<0.001
91767805|NCT00104650|183425109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33||||0.002||95.0|1.74|16.36|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||16.36|1.74|0.002
91767806|NCT00104650|183425109|SUPERIORITY_OR_OTHER||Percentage of participants|77.8||||||95.0|60.8|89.9||||||||89.9|60.8|
91767807|NCT00104650|183425109|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
91554284|NCT04868617|182996579|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.015|TWO_SIDED|95.0|-0.3|-0.03|||Mixed Models Analysis|||||-0.03|-0.3|=0.015
91554285|NCT04868617|182996580|SUPERIORITY||Mean Difference (Final Values)|-0.8|||=|0.035|TWO_SIDED|95.0|-1.5|-0.1|||Mixed Models Analysis|||||-0.1|-1.5|=0.035
91554286|NCT05495945|182996625|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
91554287|NCT05495945|182996626|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
91554288|NCT05495945|182996627|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
91554289|NCT05495945|182996628|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
91554290|NCT05155306|182996629|OTHER||Geometric mean ratio [%]|89.1|||||TWO_SIDED|90.0|79.5|99.7|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.067.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.7|79.5|
91767808|NCT00104650|183425109|SUPERIORITY_OR_OTHER||Percentage of participants|28.6||||||95.0|14.6|46.3||||||||46.3|14.6|
91767809|NCT00104650|183425110|SUPERIORITY_OR_OTHER||Percentage of participants|63.9||||||95.0|46.2|79.2||||||||79.2|46.2|
91767810|NCT00104650|183425110|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
91554291|NCT05155306|182996629|OTHER||Geometric mean ratio [%]|98.1|||||TWO_SIDED|90.0|94.4|101.9|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.022.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||101.9|94.4|
91554292|NCT05155306|182996629|OTHER||Geometric mean ratio [%]|202.4|||||TWO_SIDED|90.0|180.1|227.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.069.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||227.5|180.1|
91554293|NCT05155306|182996629|OTHER||Geometric mean ratio [%]|173.8|||||TWO_SIDED|90.0|158.3|190.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.055.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||190.8|158.3|
91767811|NCT00104650|183425110|SUPERIORITY_OR_OTHER||Percentage of participants|37.1||||||95.0|21.5|55.1||||||||55.1|21.5|
91767812|NCT00104650|183425111|SUPERIORITY_OR_OTHER|||||||0.388|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.388
91767813|NCT00104650|183425112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.79|||<|0.001||95.0|2.01|7.15|||Regression, Cox|Stratified by cancer type and screening uNTx level||||7.15|2.01|<0.001
91767814|NCT00104650|183425112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.32|||<|0.001||95.0|2.23|8.36|||Regression, Cox|Stratified by cancer type and screening uNTx level||||8.36|2.23|<0.001
91767815|NCT00104650|183425113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.274||||0.006||95.0|0.11|0.687|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.687|0.110|0.006
91554294|NCT05155306|182996630|OTHER||Geometric mean ratio [%]|83.0|||||TWO_SIDED|90.0|69.6|99.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.106.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.0|69.6|
91554295|NCT05155306|182996630|OTHER||Geometric mean ratio [%]|99.7|||||TWO_SIDED|90.0|88.7|112.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.070.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.0|88.7|
91554296|NCT05155306|182996630|OTHER||Geometric mean ratio [%]|153.6|||||TWO_SIDED|90.0|126.0|187.3|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.3|126.0|
91554297|NCT05155306|182996630|OTHER||Geometric mean ratio [%]|121.4|||||TWO_SIDED|90.0|99.6|147.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||147.8|99.6|
91554298|NCT05155306|182996631|OTHER||Geometric mean ratio [%]|89.9|||||TWO_SIDED|90.0|80.4|100.4|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.066.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.4|80.4|
91767816|NCT00104650|183425113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199||||0.001||95.0|0.076|0.523|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.523|0.076|0.001
91767817|NCT00104650|183425114|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.056
91767818|NCT00104650|183425115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.162||||0.105||95.0|0.018|1.465|||Regression, Cox|||||1.465|0.018|0.105
91554299|NCT05155306|182996631|OTHER||Geometric mean ratio [%]|100.4|||||TWO_SIDED|90.0|96.8|104.1|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.021.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.1|96.8|
91554300|NCT05155306|182996631|OTHER||Geometric mean ratio [%]|202.6|||||TWO_SIDED|90.0|179.6|228.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||228.5|179.6|
91554301|NCT05155306|182996631|OTHER||Geometric mean ratio [%]|172.3|||||TWO_SIDED|90.0|158.2|187.7|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.7|158.2|
91767819|NCT00104650|183425115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.43||95.0|0.143|2.289|||Regression, Cox|||||2.289|0.143|0.430
91767820|NCT00104650|183425116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||||95.0|0.05|1.44||||||||1.44|0.05|
91767821|NCT00104650|183425116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||||95.0|0.08|1.76||||||||1.76|0.08|
91767822|NCT03515824|183425124|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
91767823|NCT03515824|183425124|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
91554302|NCT03473223|182996643|SUPERIORITY||Hazard Ratio (HR)|0.925||||0.121|TWO_SIDED|95.0|0.8126|1.0538||1-sided p-value.|Cox proportional hazards regression|||||1.0538|0.8126|0.121
91554303|NCT03473223|182996644|SUPERIORITY||Rate ratio|0.971||||0.341|TWO_SIDED|95.0|0.8442|1.1171||1-sided p-value|Negative binomial regression model|||||1.1171|0.8442|0.341
91554304|NCT03473223|182996645|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.038|TWO_SIDED|95.0|0.8132|1.0106||1-sided p-value.|Cox proportional hazards regression|||||1.0106|0.8132|0.038
91554305|NCT03473223|182996646|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.069|TWO_SIDED|95.0|0.8511|1.0224||1-sided p-value.|Cox proportional hazards regression|||||1.0224|0.8511|0.069
91767824|NCT03515824|183425124|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|15.4|||||TWO_SIDED|80.0|5.8|30.2||||||||30.2|5.8|
91767825|NCT03515824|183425127|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
91767826|NCT03515824|183425127|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|60.2||||||||60.2|0.0|
91767827|NCT03515824|183425127|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|21.8||||||||21.8|0.0|
91767828|NCT03515824|183425128|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|84.2||||||||84.2|0.0|
91767829|NCT03515824|183425128|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
91767830|NCT03515824|183425128|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate )ORR)|0.0|||||TWO_SIDED|95.0|0.0|28.5||||||||28.5|0.0|
91554306|NCT03473223|182996647|SUPERIORITY||Hazard Ratio (HR)|0.827||||0.074|TWO_SIDED|95.0|0.6399|1.0695||1-sided p-value.|Cox proportional hazards regression|||||1.0695|0.6399|0.074
91554307|NCT03473223|182996648|SUPERIORITY||Hazard Ratio (HR)|0.909||||0.113|TWO_SIDED|95.0|0.7801|1.0603||1-sided p-value.|Cox proportional hazards regression|||||1.0603|0.7801|0.113
91554308|NCT03473223|182996649|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.767|TWO_SIDED|95.0|0.7867|1.6886||1-sided p-value.|Cox proportional hazards regression|||||1.6886|0.7867|0.767
91554309|NCT03777657|182996690|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0056|TWO_SIDED|95.0|0.59|0.94||The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.|One-sided Log Rank Test|One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.94|0.59|0.0056
91554310|NCT03777657|182996691|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0011|TWO_SIDED|95.0|0.7|0.92||The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.|One-Sided Log-Rank Test|One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.92|0.70|0.0011
91554311|NCT03777657|182996692|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.56|0.83|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.83|0.56|
91554312|NCT03777657|182996693|OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04|||||Odds ratio between arms weas calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis.|||2.04|1.03|
91554313|NCT03777657|182996694|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.67|0.9|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.90|0.67|
91767831|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.037|TWO_SIDED|95.0|0.003|0.132|||Mixed Models Analysis|||"Comparison groups were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.132|0.003|0.037
91767832|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.116|||<|0.001|TWO_SIDED|95.0|0.051|0.181|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.181|0.051|<0.001
91554314|NCT03777657|182996695|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|1.03|1.72|||||Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.|||1.72|1.03|
91554315|NCT03777657|182996698|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-0.33|3.94|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4||3.94|-0.33|
91554316|NCT03777657|182996698|OTHER||LS Mean Difference|2.52|||||TWO_SIDED|95.0|0.29|4.74|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||4.74|0.29|
91554317|NCT03777657|182996698|OTHER||LS Mean Difference|1.44|||||TWO_SIDED|95.0|-0.27|3.16||||||Analysis of Change from Baseline in Physical Functioning at Cycle 4||3.16|-0.27|
91554318|NCT03777657|182996698|OTHER||LS Mean Difference|2.46|||||TWO_SIDED|95.0|0.49|4.43|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||4.43|0.49|
91554319|NCT03777657|182996699|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.79|1.15|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 4||1.15|-3.79|
91554320|NCT03777657|182996699|OTHER||LS Mean Difference|-3.01|||||TWO_SIDED|95.0|-5.78|-0.24|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 6||-0.24|-5.78|
91554321|NCT03777657|182996700|OTHER||LS Mean Difference|-1.11|||||TWO_SIDED|95.0|-2.53|0.31|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4||0.31|-2.53|
91554322|NCT03777657|182996700|OTHER||LS Mean Difference|-1.62|||||TWO_SIDED|95.0|-3.12|-0.12|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6||-0.12|-3.12|
91554323|NCT03777657|182996700|OTHER||LS Mean Difference|-1.51|||||TWO_SIDED|95.0|-3.13|0.11|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4||0.11|-3.13|
91554324|NCT03777657|182996700|OTHER||LS Mean Difference|-0.77|||||TWO_SIDED|95.0|-2.31|0.76|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6||0.76|-2.31|
91554325|NCT03777657|182996700|OTHER||LS Mean Difference|-2.23|||||TWO_SIDED|95.0|-4.26|-0.2|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4||-0.20|-4.26|
91554326|NCT03777657|182996700|OTHER||LS Mean Difference|-1.88|||||TWO_SIDED|95.0|-4.03|0.27|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6||0.27|-4.03|
91554327|NCT03777657|182996700|OTHER||LS Mean Difference|-0.93|||||TWO_SIDED|95.0|-2.85|0.99|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4||0.99|-2.85|
91554328|NCT03777657|182996700|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.42|0.77|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6||0.77|-3.42|
91554329|NCT03777657|182996700|OTHER||LS Mean Difference|-1.59|||||TWO_SIDED|95.0|-3.28|0.09|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4||0.09|-3.28|
91767833|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.086|0.216|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.216|0.086|<0.001
91767834|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.209|0.081|<0.001
91554330|NCT03777657|182996700|OTHER||LS Mean Difference|-1.74|||||TWO_SIDED|95.0|-3.55|0.06|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6||0.06|-3.55|
91554331|NCT02549352|182996710|SUPERIORITY||Ratio of clearance rates|7.83|||<|0.001|TWO_SIDED|95.0|2.58|23.71|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|||23.71|2.58|<0.001
91554332|NCT02549352|182996711|SUPERIORITY||Ratio of clearance rates|5.91|||<|0.001|TWO_SIDED|95.0|3.32|10.51|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.51|3.32|<0.001
91554333|NCT02549352|182996712|SUPERIORITY||Ratio of clearance rates|7.59|||<|0.001|TWO_SIDED|95.0|3.7|15.61|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||15.61|3.70|<0.001
91554334|NCT02549352|182996713|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.36||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.36|0.25|<0.001
91554335|NCT02760654|182996733|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
91554336|NCT02760654|182996734|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554337|NCT02760654|182996735|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554338|NCT02760654|182996736|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554339|NCT02760654|182996737|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554340|NCT02760654|182996738|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
91554341|NCT02760654|182996739|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554342|NCT02760654|182996740|EQUIVALENCE|Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale|Calculated Mean and Standard Deviation|0.05|||||TWO_SIDED|||||||||||||
91554343|NCT02760654|182996741|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554344|NCT02760654|182996742|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91554345|NCT01574716|182996743|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.6562|TWO_SIDED|95.0|0.77|1.5|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.50|0.77|= 0.6562
91554346|NCT01574716|182996744|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.4469|TWO_SIDED|95.0|0.82|1.57|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.57|0.82|=0.4469
91554347|NCT01574716|182996745|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3153|TWO_SIDED|95.0|0.82|1.83|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.83|0.82|0.3153
91554348|NCT01574716|182996746|SUPERIORITY||Difference|-0.6|||=|1|TWO_SIDED|95.0|-12.0|10.9|||Log Rank|Two-sided log-rank test|Based on Cox PH model|Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.||10.9|-12.0|= 1.000
91554349|NCT05441449|182996760|SUPERIORITY|||||||0.002|||||||ANOVA|||||||0.002
91554350|NCT05441449|182996760|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91554351|NCT05441449|182996760|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91554352|NCT05441449|182996761|SUPERIORITY|||||||0.043|||||||ANOVA|||||||0.043
91554353|NCT05441449|182996761|SUPERIORITY|||||||0.281|||||||ANOVA|||||||0.281
91554354|NCT05441449|182996761|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91554355|NCT05441449|182996762|SUPERIORITY|||||||0.352|||||||ANOVA|||||||0.352
91554356|NCT05441449|182996762|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
91554357|NCT05441449|182996763|SUPERIORITY|||||||0.374|||||||ANOVA|||||||0.374
91554358|NCT05441449|182996763|SUPERIORITY|||||||0.045|||||||ANOVA|||||||0.045
91554359|NCT05441449|182996763|SUPERIORITY|||||||0.196|||||||ANOVA|||||||0.196
91554360|NCT02502526|182996787|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
91554361|NCT02502526|182996788|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
91554362|NCT02502526|182996788|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
91554363|NCT02502526|182996789|SUPERIORITY|||||||0.52|||||||ANCOVA|||||||0.520
91554364|NCT02502526|182996789|SUPERIORITY|||||||0.817|||||||ANCOVA|||||||0.817
91554365|NCT01074294|182996798|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.5845|TWO_SIDED|95.0|-1.8|3.19||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between Least Squares (LS) means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||3.19|-1.80|0.5845
91554366|NCT01074294|182996799|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8832|TWO_SIDED|95.0|-1.37|1.18||The p-value was derived using ANCOVA model with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.18|-1.37|0.8832
91554367|NCT01074294|182996800|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.3864|TWO_SIDED|95.0|-0.72|1.86||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.86|-0.72|0.3864
91554368|NCT01074294|182996801|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.0061|TWO_SIDED|95.0|0.1|0.58||The p value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.58|0.10|0.0061
91554369|NCT01074294|182996802|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6932|TWO_SIDED|95.0|-1.64|2.46||The p-value was derived from ANCOVA model, with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.46|-1.64|0.6932
91554370|NCT01074294|182996803|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.2781|TWO_SIDED|95.0|-0.66|2.28||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.28|-0.66|0.2781
91554371|NCT01074294|182996803|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.4673|TWO_SIDED|95.0|-1.15|2.49||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.49|-1.15|0.4673
91554372|NCT01074294|182996803|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.5719|TWO_SIDED|95.0|-1.54|2.79||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.79|-1.54|0.5719
91554373|NCT01074294|182996803|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.6262|TWO_SIDED|95.0|-1.7|2.83||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||2.83|-1.70|0.6262
91554374|NCT01074294|182996803|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2638|TWO_SIDED|95.0|-1.06|3.87||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.87|-1.06|0.2638
91554375|NCT01074294|182996804|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.3804|TWO_SIDED|95.0|-0.52|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.37|-0.52|0.3804
91554376|NCT01074294|182996804|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.6422|TWO_SIDED|95.0|-0.86|1.39||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.39|-0.86|0.6422
91554377|NCT01074294|182996804|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.6707|TWO_SIDED|95.0|-1.0|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.55|-1.00|0.6707
91554378|NCT01074294|182996804|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.6638|TWO_SIDED|95.0|-1.04|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.64|-1.04|0.6638
91767835|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.211|||<|0.001|TWO_SIDED|95.0|0.159|0.263|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.263|0.159|<0.001
91767836|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.066|TWO_SIDED|95.0|-0.003|0.1|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.100|-0.003|0.066
91767837|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.002|TWO_SIDED|95.0|0.031|0.135|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.135|0.031|0.002
91767838|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.003|TWO_SIDED|95.0|0.026|0.128|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.128|0.026|0.003
91554379|NCT01074294|182996804|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2252|TWO_SIDED|95.0|-0.56|2.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.36|-0.56|0.2252
91554380|NCT01074294|182996804|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.697|TWO_SIDED|95.0|-1.14|1.7||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.70|-1.14|0.6970
91554381|NCT01074294|182996805|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.6008|TWO_SIDED|95.0|-0.64|1.11||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.11|-0.64|0.6008
91554382|NCT01074294|182996805|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.5859|TWO_SIDED|95.0|-0.72|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.27|-0.72|0.5859
91554383|NCT01074294|182996805|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.7406|TWO_SIDED|95.0|-0.96|1.34||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.34|-0.96|0.7406
91554384|NCT01074294|182996805|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8568|TWO_SIDED|95.0|-1.14|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.37|-1.14|0.8568
91554385|NCT01074294|182996805|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6044|TWO_SIDED|95.0|-0.96|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.64|-0.96|0.6044
91554386|NCT01074294|182996805|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.6772|TWO_SIDED|95.0|-1.08|1.66||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.66|-1.08|0.6772
91554387|NCT01074294|182996806|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7881|TWO_SIDED|95.0|-0.87|1.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.15|-0.87|0.7881
91554388|NCT01074294|182996806|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8841|TWO_SIDED|95.0|-1.38|1.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.19|-1.38|0.8841
91554389|NCT01074294|182996806|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.7589|TWO_SIDED|95.0|-1.61|1.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.17|-1.61|0.7589
91554390|NCT01074294|182996806|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.5375|TWO_SIDED|95.0|-1.01|1.93||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.93|-1.01|0.5375
91554391|NCT01074294|182996806|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.4456|TWO_SIDED|95.0|-0.92|2.08||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.08|-0.92|0.4456
91554392|NCT01074294|182996806|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.667|TWO_SIDED|95.0|-1.21|1.89||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.89|-1.21|0.6670
91554393|NCT01074294|182996807|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9708|TWO_SIDED|95.0|-0.97|1.01||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.01|-0.97|0.9708
91554394|NCT01074294|182996807|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.397|TWO_SIDED|95.0|-0.65|1.63||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.63|-0.65|0.3970
91554395|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9568|TWO_SIDED|95.0|0.68|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 7||1.50|0.68|0.9568
91554396|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|0.91||||0.6308|TWO_SIDED|95.0|0.63|1.31||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 9||1.31|0.63|0.6308
91554397|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|0.92||||0.6698|TWO_SIDED|95.0|0.64|1.32||The p-value was derived from CMH general association test controlling for study center|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 11||1.32|0.64|0.6698
91554398|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|0.76||||0.2012|TWO_SIDED|95.0|0.5|1.15||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 7||1.15|0.50|0.2012
91554399|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|0.78||||0.2365|TWO_SIDED|95.0|0.52|1.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 9||1.16|0.52|0.2365
91554400|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 11||0.96|0.44|0.0312
91554401|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6408|TWO_SIDED|95.0|0.69|1.81||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 7||1.81|0.69|0.6408
91554402|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|1.24||||0.3467|TWO_SIDED|95.0|0.79|1.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 9||1.96|0.79|0.3467
91554403|NCT01074294|182996808|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9437|TWO_SIDED|95.0|0.65|1.59||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 11||1.59|0.65|0.9437
91554404|NCT01074294|182996809|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6357|TWO_SIDED|95.0|-1.3|2.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.12|-1.30|0.6357
91554405|NCT01074294|182996809|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.6536|TWO_SIDED|95.0|-1.56|2.48||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.48|-1.56|0.6536
91554406|NCT01074294|182996809|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9475|TWO_SIDED|95.0|-2.2|2.06||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.06|-2.20|0.9475
91554407|NCT01074294|182996809|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.3973|TWO_SIDED|95.0|-1.31|3.29||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||3.29|-1.31|0.3973
91767839|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.189|TWO_SIDED|95.0|-0.017|0.087|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.087|-0.017|0.189
91554408|NCT01074294|182996809|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.2336|TWO_SIDED|95.0|-0.96|3.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.91|-0.96|0.2336
91767840|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.273|TWO_SIDED|95.0|-0.023|0.08|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.080|-0.023|0.273
91554409|NCT01074294|182996809|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.4553|TWO_SIDED|95.0|-1.55|3.44||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||3.44|-1.55|0.4553
91554410|NCT01074294|182996810|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.5647|TWO_SIDED|95.0|-0.7|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.27|-0.70|0.5647
91554411|NCT01074294|182996810|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9739|TWO_SIDED|95.0|-1.15|1.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.12|-1.15|0.9739
91767841|NCT03084796|183425139|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.813|TWO_SIDED|95.0|-0.058|0.045|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.045|-0.058|0.813
91554412|NCT01074294|182996810|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8077|TWO_SIDED|95.0|-1.4|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.09|-1.40|0.8077
91554413|NCT01074294|182996810|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6119|TWO_SIDED|95.0|-0.98|1.65||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.65|-0.98|0.6119
91554414|NCT01074294|182996810|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.5513|TWO_SIDED|95.0|-0.94|1.76||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.76|-0.94|0.5513
91554415|NCT01074294|182996810|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4185|TWO_SIDED|95.0|-0.81|1.95||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.95|-0.81|0.4185
91554416|NCT01074294|182996811|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.7556|TWO_SIDED|95.0|-0.8|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.09|-0.80|0.7556
91554417|NCT01074294|182996811|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.371|TWO_SIDED|95.0|-0.6|1.59||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.59|-0.60|0.3710
91554418|NCT01074294|182996811|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.8464|TWO_SIDED|95.0|-0.99|1.21||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.21|-0.99|0.8464
91554419|NCT01074294|182996811|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.2664|TWO_SIDED|95.0|-0.53|1.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.91|-0.53|0.2664
91767842|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.002|TWO_SIDED|95.0|0.022|0.095|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.095|0.022|0.002
91554420|NCT01074294|182996811|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.0876|TWO_SIDED|95.0|-0.17|2.42||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.42|-0.17|0.0876
91767843|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.04|0.113|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.113|0.040|<0.001
91767844|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.089|0.163|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.163|0.089|<0.001
91554421|NCT01074294|182996811|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.5119|TWO_SIDED|95.0|-0.89|1.77||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.77|-0.89|0.5119
91767845|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.104|0.177|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.177|0.104|<0.001
91554422|NCT01074294|182996812|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8986|TWO_SIDED|95.0|-1.03|1.18||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.18|-1.03|0.8986
91554423|NCT01074294|182996812|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.685|TWO_SIDED|95.0|-1.02|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.55|-1.02|0.6850
91554424|NCT01074294|182996812|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.7108|TWO_SIDED|95.0|-1.61|1.1||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.10|-1.61|0.7108
91554425|NCT01074294|182996812|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9236|TWO_SIDED|95.0|-1.5|1.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.36|-1.50|0.9236
91554426|NCT01074294|182996812|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.8576|TWO_SIDED|95.0|-1.35|1.61||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.61|-1.35|0.8576
91554427|NCT01074294|182996812|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8483|TWO_SIDED|95.0|-1.67|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.37|-1.67|0.8483
91767846|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.147|0.22|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.220|0.147|<0.001
91767847|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.322|TWO_SIDED|95.0|-0.018|0.055|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.055|-0.018|0.322
91767848|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.067|||<|0.001|TWO_SIDED|95.0|0.031|0.104|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.104|0.031|<0.001
91767849|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.045|0.118|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.118|0.045|<0.001
91767850|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.008|TWO_SIDED|95.0|0.013|0.086|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.086|0.013|0.008
91554428|NCT01074294|182996813|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6976|TWO_SIDED|95.0|-0.22|0.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||0.15|-0.22|0.6976
91554429|NCT01074294|182996813|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6986|TWO_SIDED|95.0|-0.25|0.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||0.17|-0.25|0.6986
91554430|NCT01074294|182996813|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6507|TWO_SIDED|95.0|-0.3|0.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||0.19|-0.30|0.6507
91554431|NCT01074294|182996813|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.655|TWO_SIDED|95.0|-0.32|0.2||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||0.20|-0.32|0.6550
91554432|NCT01074294|182996813|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.3959|TWO_SIDED|95.0|-0.15|0.38||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||0.38|-0.15|0.3959
91554433|NCT01074294|182996813|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6763|TWO_SIDED|95.0|-0.23|0.35||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||0.35|-0.23|0.6763
91554434|NCT01074294|182996814|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.4089|TWO_SIDED|95.0|-0.37|0.91||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.91|-0.37|0.4089
91554435|NCT01074294|182996815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2331|TWO_SIDED|95.0|-0.8|0.2||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||Week 11 data is included here. The planned sample size of 225 participants (150 in brexipiprazole arm and 75 in the placebo arm) yielded at least 80% power to detect effects at a 2-tailed significance level of 0.05 using a two-sided z-test.|||0.20|-0.80|0.2331
91554436|NCT01074294|182996816|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.067|TWO_SIDED|95.0|-0.01|0.0||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.00|-0.01|0.0670
91554437|NCT01074294|182996817|SUPERIORITY||Mean Difference (Final Values)|-14.3||||0.0849|TWO_SIDED|95.0|-30.5|1.98||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.98|-30.5|0.0849
91554438|NCT01074294|182996818|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.7663|TWO_SIDED|95.0|-3.52|2.6||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.60|-3.52|0.7663
91554439|NCT01074294|182996819|SUPERIORITY||Mean Difference (Final Values)|17.51||||0.0298|TWO_SIDED|95.0|1.73|33.29||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||33.29|1.73|0.0298
91767851|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.063|||<|0.001|TWO_SIDED|95.0|0.027|0.1|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.100|0.027|<0.001
91554440|NCT01074294|182996820|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.2563|TWO_SIDED|95.0|-0.05|0.01||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.01|-0.05|0.2563
91554441|NCT01074294|182996821|SUPERIORITY||Mean Difference (Final Values)|-5.67||||0.6644|TWO_SIDED|95.0|-31.4|20.06||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||20.06|-31.4|0.6644
91554442|NCT01074294|182996822|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.8418|TWO_SIDED|95.0|-0.56|0.45||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.45|-0.56|0.8418
91767852|NCT03084796|183425140|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.443|TWO_SIDED|95.0|-0.022|0.051|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.051|-0.022|0.443
91767853|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.072|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.105|0.038|<0.001
91554443|NCT01074294|182996823|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2513|TWO_SIDED|95.0|-0.69|0.18||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.18|-0.69|0.2513
91554444|NCT01074294|182996824|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.7037|TWO_SIDED|95.0|-0.48|0.71||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.71|-0.48|0.7037
91554445|NCT01074294|182996825|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7572|TWO_SIDED|95.0|-0.17|0.23||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||0.23|-0.17|0.7572
91554446|NCT01074294|182996825|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6132|TWO_SIDED|95.0|-0.28|0.17||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||0.17|-0.28|0.6132
91554447|NCT01074294|182996825|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9312|TWO_SIDED|95.0|-0.25|0.27||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||0.27|-0.25|0.9312
91554448|NCT01074294|182996825|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.8073|TWO_SIDED|95.0|-0.3|0.24||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||0.24|-0.30|0.8073
91554449|NCT01074294|182996825|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9168|TWO_SIDED|95.0|-0.26|0.29||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||0.29|-0.26|0.9168
91554450|NCT01074294|182996825|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7432|TWO_SIDED|95.0|-0.34|0.25||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||0.25|-0.34|0.7432
91554451|NCT01074294|182996826|SUPERIORITY||Risk Ratio (RR)|1.2||||0.6014|TWO_SIDED|95.0|0.6|2.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.42|0.60|0.6014
91554452|NCT01074294|182996826|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9225|TWO_SIDED|95.0|0.64|1.63||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.63|0.64|0.9225
91554453|NCT01074294|182996826|SUPERIORITY||Risk Ratio (RR)|0.86||||0.4803|TWO_SIDED|95.0|0.58|1.3||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.30|0.58|0.4803
91554454|NCT01074294|182996826|SUPERIORITY||Risk Ratio (RR)|0.91||||0.5876|TWO_SIDED|95.0|0.65|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.27|0.65|0.5876
91554455|NCT01074294|182996826|SUPERIORITY||Risk Ratio (RR)|0.87||||0.3727|TWO_SIDED|95.0|0.64|1.18||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.18|0.64|0.3727
91554456|NCT01074294|182996826|SUPERIORITY||Risk Ratio (RR)|0.93||||0.6265|TWO_SIDED|95.0|0.71|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.71|0.6265
91554457|NCT01074294|182996827|SUPERIORITY||Risk Ratio (RR)|1.1||||0.8586|TWO_SIDED|95.0|0.4|3.03||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.03|0.40|0.8586
91554458|NCT01074294|182996827|SUPERIORITY||Risk Ratio (RR)|0.95||||0.8984|TWO_SIDED|95.0|0.46|1.99||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.99|0.46|0.8984
91554459|NCT01074294|182996827|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9778|TWO_SIDED|95.0|0.57|1.74||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.74|0.57|0.9778
91554460|NCT01074294|182996827|SUPERIORITY||Risk Ratio (RR)|0.92||||0.7315|TWO_SIDED|95.0|0.56|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.50|0.56|0.7315
91554461|NCT01074294|182996827|SUPERIORITY||Risk Ratio (RR)|0.9||||0.6518|TWO_SIDED|95.0|0.57|1.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.42|0.57|0.6518
91554462|NCT01074294|182996827|SUPERIORITY||Risk Ratio (RR)|0.82||||0.3472|TWO_SIDED|95.0|0.55|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.55|0.3472
91554463|NCT01074294|182996828|SUPERIORITY||Risk Ratio (RR)|0.98||||0.9577|TWO_SIDED|95.0|0.44|2.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.16|0.44|0.9577
91554464|NCT01074294|182996828|SUPERIORITY||Risk Ratio (RR)|1.19||||0.5864|TWO_SIDED|95.0|0.63|2.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.27|0.63|0.5864
91554465|NCT01074294|182996828|SUPERIORITY||Risk Ratio (RR)|0.96||||0.8723|TWO_SIDED|95.0|0.57|1.6||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.60|0.57|0.8723
91554466|NCT01074294|182996828|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9872|TWO_SIDED|95.0|0.65|1.52||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.52|0.65|0.9872
91554467|NCT01074294|182996828|SUPERIORITY||Risk Ratio (RR)|0.8||||0.3171|TWO_SIDED|95.0|0.52|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.23|0.52|0.3171
91554468|NCT01074294|182996828|SUPERIORITY||Risk Ratio (RR)|0.87||||0.4782|TWO_SIDED|95.0|0.6|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.27|0.60|0.4782
91554469|NCT01074294|182996829|SUPERIORITY||Risk Ratio (RR)|1.19||||0.7232|TWO_SIDED|95.0|0.45|3.19||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.19|0.45|0.7232
91554470|NCT01074294|182996829|SUPERIORITY||Risk Ratio (RR)|0.99||||0.986|TWO_SIDED|95.0|0.46|2.13||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.13|0.46|0.9860
91554471|NCT01074294|182996829|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9858|TWO_SIDED|95.0|0.52|1.95||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.95|0.52|0.9858
91554472|NCT01074294|182996829|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9466|TWO_SIDED|95.0|0.58|1.78||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.78|0.58|0.9466
91554473|NCT01074294|182996829|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6962|TWO_SIDED|95.0|0.63|2.0||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||2.00|0.63|0.6962
91554474|NCT01074294|182996829|SUPERIORITY||Risk Ratio (RR)|0.93||||0.7637|TWO_SIDED|95.0|0.57|1.51||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.51|0.57|0.7637
91554475|NCT01074294|182996830|SUPERIORITY||Risk Ratio (RR)|1.3||||0.3631|TWO_SIDED|95.0|0.73|2.33||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.33|0.73|0.3631
91554476|NCT01074294|182996830|SUPERIORITY||Risk Ratio (RR)|1.35||||0.2786|TWO_SIDED|95.0|0.78|2.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.35|0.78|0.2786
91554477|NCT01074294|182996830|SUPERIORITY||Risk Ratio (RR)|1.08||||0.7062|TWO_SIDED|95.0|0.72|1.62||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.62|0.72|0.7062
91554478|NCT01074294|182996830|SUPERIORITY||Risk Ratio (RR)|0.95||||0.7844|TWO_SIDED|95.0|0.67|1.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.35|0.67|0.7844
91554479|NCT01074294|182996830|SUPERIORITY||Risk Ratio (RR)|1.07||||0.694|TWO_SIDED|95.0|0.77|1.48||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.48|0.77|0.6940
91554480|NCT01074294|182996830|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8697|TWO_SIDED|95.0|0.76|1.39||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.39|0.76|0.8697
91554481|NCT00112359|182996831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.98||||0.0006|TWO_SIDED|95.0|3.5|12.47||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.||12.47|3.50|0.0006
91554482|NCT00112359|182996832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33||||0.0154|TWO_SIDED|95.0|1.22|11.43||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.||11.43|1.22|0.0154
91554483|NCT00112359|182996835|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.294|||<|0.0001|TWO_SIDED|95.0|6.288|14.299||Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.|ANCOVA|ANCOVA model included treatment, disease severity (FEV1 \>50% or \<=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.||14.299|6.288|<0.0001
91554484|NCT00112359|182996836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.453|||<|0.0001|TWO_SIDED|95.0|-2.115|-0.791||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|ANCOVA|ANCOVA model included terms for treatment and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.||-0.791|-2.115|< 0.0001
91554485|NCT00112359|182996837|SUPERIORITY_OR_OTHER|||||||0.2364||95.0||||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|Fisher Exact|Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||0.2364
91554486|NCT00112359|182996838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.71||||0.0005|TWO_SIDED|95.0|4.31|15.11||"Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~A sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05."||15.11|4.31|0.0005
91554487|NCT00112359|182996839|SUPERIORITY_OR_OTHER|||||||0.064||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.||||0.0640
91554488|NCT00312208|182996841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.978||95.0|0.86|1.16||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.16|0.86|0.978
91554489|NCT00312208|182996842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.371||95.0|0.75|1.11||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.11|0.75|0.371
91554490|NCT04612244|182996844|NON_INFERIORITY|"PT will be deemed to be non-inferior to PC if it can be established that the posterior probability Pr(HA \| data) \> Ψeff, where Ψeff is a pre-specified threshold value that controls the one-sided type I error rate (under simulation) at level 0.05. In the absence of missing data, the posterior distributions for PT and PC would be conjugate Beta distributions."||||||0.05|||||||t-test, 1 sided|||"The primary effectiveness endpoint for this study is Treatment Success, which will be analyzed as a test of non-inferiority of the event rate at 12 months using a noninferiority margin of 15%.~The null and alternative hypotheses are:~H0: PT ≤ PC - 0.15 versus HA: PT \> PC - 0.15 where PT is the Treatment Success rate at 12 months in the Pulsed Field Group and PC is the Treatment Success rate at 12 months in the Thermal (Control) Group."||||0.05
91554491|NCT04612244|182996846|SUPERIORITY|"The null and alternative hypotheses are provided below. H0: PT ≤ PC versus HA: PT \> PC where PT is the Treatment Success rate at 12 months in the Pulsed Field Group, and PC is the Treatment Success rate at 12 months in the Thermal Group.~Modeling will be identical primary endpoint and superiority concluded if the posterior probability Pr(HA \| data) \> Ψeff, sup, where the threshold Ψeff,sup is a pre-specified threshold value that controls the one-sided type I error rate at level 0.025."|Median Difference (Final Values)|0.708||||0.025|ONE_SIDED|97.5|||||t-test, 1 sided|||The secondary effectiveness endpoint for the ADVENT Trial is Treatment Superiority uses the same definition as the primary effectiveness endpoint for Treatment Success, but the test is for superiority between MITT subjects in the PFA and Thermal Groups.||||0.025
91554492|NCT03260569|182996849|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91554493|NCT00712179|182996898|SUPERIORITY_OR_OTHER|||||||0.981|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.||||0.981
91554494|NCT00712179|182996898|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mixed Models Analysis|||Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG pattern||||0.84
91554495|NCT00712179|182996898|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.||||0.16
91554496|NCT00712179|182996898|SUPERIORITY_OR_OTHER|||||||0.073|||||||Mixed Models Analysis|||Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.||||0.073
91554497|NCT00712179|182996898|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.||||<0.001
91554498|NCT00712179|182996898|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.||||0.94
91554499|NCT00246805|182996921|SUPERIORITY_OR_OTHER||Proportions|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0|||Z-test for proportions|||VRS ON vs. VRS OFF||61|36|<0.0001
91554500|NCT01500200|182996933|SUPERIORITY|||||||0.014||||||Hypothesis tests were two-sided with an alpha of 0.5.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2.||||0.014
91554501|NCT01500200|182996933|SUPERIORITY|||||||0.699||||||Hypothesis tests were two-sided with an alpha of 0.05.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.||||0.699
91554502|NCT03066609|182996943|SUPERIORITY||Odds Ratio (OR)|153.94|||<|0.0001|TWO_SIDED|95.0|54.02|438.67|||Regression, Logistic|||PASI 75||438.67|54.02|<0.0001
91554503|NCT03066609|182996943|SUPERIORITY||Odds Ratio (OR)|557.98|||<|0.0001|TWO_SIDED|95.0|187.2|1663.4|||Regression, Logistic|||PASI 75||1663.4|187.2|<0.0001
91767854|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.052|0.119|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.119|0.052|<0.001
91767855|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.143|||<|0.001|TWO_SIDED|95.0|0.109|0.177|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.177|0.109|<0.001
91554504|NCT03066609|182996944|SUPERIORITY||Odds Ratio (OR)|75.82|||<|0.0001|TWO_SIDED|95.0|25.81|222.72|||Regression, Logistic|||IGA||222.72|25.81|<0.0001
91767856|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.127|0.194|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.194|0.127|<0.001
91767857|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.164|||<|0.001|TWO_SIDED|95.0|0.131|0.198|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.198|0.131|<0.001
91554505|NCT03066609|182996944|SUPERIORITY||Odds Ratio (OR)|149.71|||<|0.0001|TWO_SIDED|95.0|51.83|432.42|||Regression, Logistic|||IGA||432.42|51.83|<0.0001
91554506|NCT03066609|182996945|SUPERIORITY||Odds Ratio (OR)|114.85|||<|0.0001|TWO_SIDED|95.0|26.94|489.59|||Regression, Logistic|||PASI 90||489.59|26.94|<0.0001
91554507|NCT03066609|182996945|SUPERIORITY||Odds Ratio (OR)|246.12|||<|0.0001|TWO_SIDED|95.0|58.41|1037.1|||Regression, Logistic|||PASI 90||1037.1|58.41|<0.0001
91554508|NCT04191824|182996960|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.7769|TWO_SIDED|95.0|-2.7|2.1||In order to maintain an overall alpha of 0.05 and account for two interim analyses, a two-sided alpha of 0.0492 was used for assessing the statistical significance in the final analysis of this primary endpoint.|t-test, 2 sided|||||2.1|-2.7|0.7769
91554509|NCT04191824|182996961|SUPERIORITY||Risk Difference (RD)|0.106|||<|0.0001|TWO_SIDED|95.0|0.061|0.151|||Chi-squared|||||0.151|0.061|<0.0001
91554510|NCT04191824|182996962|SUPERIORITY||Risk Difference (RD)|0.057||||0.0753|TWO_SIDED|95.0|-0.006|0.12|||Chi-squared|||||0.120|-0.006|0.0753
91554511|NCT04191824|182996963|SUPERIORITY||Risk Difference (RD)|0.002||||0.8044|TWO_SIDED|95.0|-0.013|0.016|||Chi-squared|||||0.016|-0.013|0.8044
91554512|NCT04191824|182996964|SUPERIORITY||Risk Difference (RD)|-0.052||||0.057|TWO_SIDED|95.0|-0.105|0.002|||Chi-squared|||||0.002|-0.105|0.0570
91554513|NCT04191824|182996965|SUPERIORITY||Risk Difference (RD)|0.045||||0.0012|TWO_SIDED|95.0|0.018|0.072|||Chi-squared|||||0.072|0.018|0.0012
91554514|NCT04191824|182996966|SUPERIORITY||Risk Difference (RD)|-0.006||||0.8483|TWO_SIDED|95.0|-0.066|0.055|||Chi-squared|||||0.055|-0.066|0.8483
91554515|NCT01324310|182996970|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric Mean|124.4|||||TWO_SIDED|90.0|110.2|140.5|||ANOVA||"Geometric means ratio (Romidepsin + Ketoconazole/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||140.5|110.2|
91554516|NCT01324310|182996971|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|123.7|||||TWO_SIDED|90.0|109.6|139.6|||ANOVA|||||139.6|109.6|
91554517|NCT01324310|182996972|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|124.6|||||TWO_SIDED|90.0|109.0|142.4|||ANOVA|||||142.4|109.0|
91554518|NCT01324310|182996973|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|109.5|||||TWO_SIDED|90.0|94.9|126.4|||ANOVA|||||126.4|94.9|
91554519|NCT01324310|182996974|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.7422|TWO_SIDED|90.0|-0.485|0.095|||Wilcoxon signed- rank|||"Note: The median, median difference (romidepsin + ketoconazole minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||0.095|-0.485|0.7422
91554520|NCT03170882|182996979|SUPERIORITY||Hazard Ratio (HR)|0.847|||=|0.477|TWO_SIDED|95.0|0.535|1.341|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age,international staging system(ISS),prior lines of therapy. HR\<1 was deemed to indicate better PFS in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.341|0.535|=0.477
91554521|NCT03170882|182996980|SUPERIORITY||Hazard Ratio (HR)|1.427|||=|0.265|TWO_SIDED|95.0|0.761|2.677|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.|||2.677|0.761|=0.265
91554522|NCT03170882|182996981|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.634|TWO_SIDED|95.0|0.43|1.9|||Cochran-Mantel-Haenszel||OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.90|0.43|=0.634
91554523|NCT03170882|182996983|SUPERIORITY||Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.288|1.073|||||HR was obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS, prior lines of therapy. HR \>1 was deemed to indicate quicker response time in Ixazomib + Dexamethasone arm over Pomalidomide + Dexamethasone arm.|||1.073|0.288|
91554524|NCT03170882|182996984|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.459|TWO_SIDED|95.0|0.506|1.361|||Log Rank||HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.361|0.506|=0.459
91554525|NCT01371994|182996994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1745|TWO_SIDED||||||Log Rank|Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and \> 3).||The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \>3) at a 2-sided significance level of 0.05.||||0.1745
91554526|NCT01371994|182996995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4833|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 4||||0.4833
91554527|NCT01371994|182996995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5761|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 8||||0.5761
91554528|NCT01371994|182996995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0592|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 12||||0.0592
91554529|NCT01371994|182996995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison of end of treatment analysis||||0.0390
91554530|NCT01371994|182996997|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3604|TWO_SIDED|95.0|-0.14|0.38|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 4||0.38|-0.14|0.3604
91554531|NCT01371994|182996997|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0761|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 8||0.52|-0.03|0.0761
91554532|NCT01371994|182996997|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0149|TWO_SIDED|95.0|0.07|0.64|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 12||0.64|0.07|0.0149
91554533|NCT01371994|182996997|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0325|TWO_SIDED|95.0|0.02|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison of end of treatment analysis||0.52|0.02|0.0325
91554534|NCT01371994|182996999|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5186|TWO_SIDED|95.0|-0.6|1.19|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.19|-0.60|0.5186
91554535|NCT01371994|182996999|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.43||0.4521|TWO_SIDED|95.0|-0.52|1.17|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.17|-0.52|0.4521
91554536|NCT01371994|182997001|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1493|TWO_SIDED|95.0|-0.07|0.47|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||0.47|-0.07|0.1493
91554537|NCT01371994|182997001|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1499|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||0.44|-0.07|0.1499
91554538|NCT01371994|182997003|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1279|TWO_SIDED|95.0|-0.16|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.23|-0.16|0.1279
91554539|NCT01371994|182997003|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.1038|TWO_SIDED|95.0|-0.11|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.23|-0.11|0.1038
91554540|NCT01371994|182997005|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.98||0.8876|TWO_SIDED|95.0|-4.19|3.63|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||3.63|-4.19|0.8876
91554541|NCT01371994|182997005|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.86||0.395|TWO_SIDED|95.0|-8.1|3.21|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||3.21|-8.10|0.3950
91554542|NCT01371994|182997007|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.43||0.4126|TWO_SIDED|95.0|-2.82|6.81|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.81|-2.82|0.4126
91554543|NCT01371994|182997007|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.0|STANDARD_ERROR_OF_MEAN|2.47||0.6959|TWO_SIDED|95.0|-3.92|5.85|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.85|-3.92|0.6959
91554544|NCT01371994|182997009|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|3.3|STANDARD_ERROR_OF_MEAN|2.81||0.2402|TWO_SIDED|95.0|-2.26|8.91|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||8.91|-2.26|0.2402
91554545|NCT01371994|182997009|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|STANDARD_ERROR_OF_MEAN|2.83||0.698|TWO_SIDED|95.0|-4.5|6.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||6.70|-4.50|0.6980
91554546|NCT01371994|182997011|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.46||0.4067|TWO_SIDED|95.0|-2.8|6.89|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.89|-2.80|0.4067
91554547|NCT01371994|182997011|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|2.36||0.8507|TWO_SIDED|95.0|-4.21|5.1|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.10|-4.21|0.8507
91767858|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.418|TWO_SIDED|95.0|-0.02|0.048|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.048|-0.020|0.418
91767859|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.071|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.105|0.038|<0.001
91554548|NCT01371994|182997012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center.||||||0.2700
91767860|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.089|||<|0.001|TWO_SIDED|95.0|0.055|0.122|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.122|0.055|<0.001
91767861|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.024|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|0.024|<0.001
91767862|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.041|0.108|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|0.041|<0.001
91554549|NCT03213457|182997015|SUPERIORITY||Odds Ratio (OR)|5.51|||<|0.001|TWO_SIDED|95.0|3.711|8.176||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||8.176|3.711|< 0.001
91554550|NCT03213457|182997015|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.968|6.331||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||6.331|2.968|< 0.001
91554551|NCT03213457|182997016|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.275|2.605||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||2.605|1.275|< 0.001
91554552|NCT03213457|182997016|SUPERIORITY||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.146|2.326||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||2.326|1.146|0.007
91554553|NCT03213457|182997017|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-1.18|-0.809||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|mixed model repeated measures (MMRM)|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.809|-1.180|< 0.001
91554554|NCT03213457|182997018|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.088|<|0.001|TWO_SIDED|95.0|-1.19|-0.845||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.845|-1.190|< 0.001
91554555|NCT03213457|182997019|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-1.156|-0.823||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.823|-1.156|< 0.001
91554556|NCT03213457|182997020|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.073||0.002|TWO_SIDED|95.0|-0.367|-0.08||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.080|-0.367|0.002
91554557|NCT03213457|182997021|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|-0.329|-0.085||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.085|-0.329|< 0.001
91767863|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.308|TWO_SIDED|95.0|-0.016|0.051|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.051|-0.016|0.308
91767864|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.092|||<|0.001|TWO_SIDED|95.0|0.038|0.147|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.147|0.038|<0.001
91767865|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.079|0.188|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.188|0.079|<0.001
91767866|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.12|0.229|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.229|0.120|<0.001
91767867|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.127|0.235|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.127|<0.001
91767868|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.229|||<|0.001|TWO_SIDED|95.0|0.175|0.284|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.284|0.175|<0.001
91554558|NCT03213457|182997022|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED|95.0|-0.27|-0.05||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.050|-0.270|0.004
91554559|NCT03213457|182997023|SUPERIORITY||LS Mean of Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.9||0.005|TWO_SIDED|95.0|-4.283|-0.746||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.746|-4.283|0.005
91554560|NCT03213457|182997024|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.098||0.284|TWO_SIDED|95.0|-0.298|0.088||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.088|-0.298|0.284
91767869|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.141|TWO_SIDED|95.0|-0.013|0.095|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.013|0.141
91767870|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.137|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.137|0.028|0.003
91767871|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.001|TWO_SIDED|95.0|0.035|0.142|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.142|0.035|0.001
91767872|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.137|TWO_SIDED|95.0|-0.013|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.013|0.137
91767873|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.006|0.082
91767874|NCT03084796|183425141|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.823|TWO_SIDED|95.0|-0.048|0.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.060|-0.048|0.823
91767875|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.002|TWO_SIDED|95.0|0.022|0.1|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.100|0.022|0.002
91767876|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.036|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|0.036|<0.001
91767877|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.085|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.085|<0.001
91767878|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.113|0.19|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|0.113|<0.001
91767879|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.124|0.202|||MMRM|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.202|0.124|<0.001
91767880|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.485|TWO_SIDED|95.0|-0.025|0.052|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.052|-0.025|0.485
91554561|NCT03213457|182997025|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.286|TWO_SIDED|95.0|-0.279|0.083||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.083|-0.279|0.286
91554562|NCT03213457|182997026|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.079||0.005|TWO_SIDED|95.0|-0.375|-0.066||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.066|-0.375|0.005
91554563|NCT03213457|182997027|SUPERIORITY||LS Mean of Difference|-2.49|STANDARD_ERROR_OF_MEAN|1.158||0.032|TWO_SIDED|95.0|-4.773|-0.216||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.216|-4.773|0.032
91554564|NCT03213457|182997028|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.774|-0.508||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.508|-1.774|< 0.001
91554565|NCT03213457|182997029|SUPERIORITY||LS Mean of Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.303|<|0.001|TWO_SIDED|95.0|-1.978|-0.788||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.788|-1.978|< 0.001
91554566|NCT03213457|182997030|SUPERIORITY||LS Mean of Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.002|-0.915||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.915|-2.002|< 0.001
91554567|NCT01830595|182997032|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91554568|NCT01830595|182997034|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91554569|NCT01830595|182997035|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
91554570|NCT00747565|182997101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||ETDRS line scores used for statistical comparisons with mean Snellen values reported above.||||<0.0001
91554571|NCT01983683|182997105|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.7|||||TWO_SIDED|95.0|-10.7|1.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||1.3|-10.7|
91554572|NCT01983683|182997105|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-3.6|||||TWO_SIDED|95.0|-9.6|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||2.3|-9.6|
91554573|NCT01983683|182997106|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.9|||||TWO_SIDED|95.0|-10.4|0.6|||||CI for the difference between two proportions are estimated using the Wilson' score method|||0.6|-10.4|
91554574|NCT01983683|182997107|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|1.7|||||TWO_SIDED|95.0|-6.1|9.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|||9.4|-6.1|
91554575|NCT01983683|182997108|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7794|TWO_SIDED|95.0|0.86|1.24||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.24|0.86|0.7794
91554576|NCT01983683|182997109|SUPERIORITY||Least Square Mean difference|-0.044||||0.6871|TWO_SIDED|95.0|-0.26|0.17||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.17|-0.26|0.6871
91554577|NCT01983683|182997109|SUPERIORITY||Least Square Mean difference|0.025||||0.7833|TWO_SIDED|95.0|-0.15|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.20|-0.15|0.7833
91554578|NCT01983683|182997109|SUPERIORITY||Least Square Mean difference|0.061||||0.4145|TWO_SIDED|95.0|-0.09|0.21||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the other symptoms domain scores||0.21|-0.09|0.4145
91554579|NCT01983683|182997110|OTHER||Difference between 2 proportions|-1.1|||||TWO_SIDED|95.0|-6.5|4.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||4.2|-6.5|
91554580|NCT01983683|182997111|OTHER||Difference between 2 proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||3.3|-6.5|
91554581|NCT01983683|182997112|OTHER||Difference between 2 proportions|8.8|||||TWO_SIDED|95.0|1.1|16.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||16.4|1.1|
91554582|NCT01983683|182997113|SUPERIORITY|Sensitivity analysis|Difference between 2 proportions|2.7|||||TWO_SIDED|95.0|-5.5|10.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.9|-5.5|
91554583|NCT02722434|182997121|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
91554584|NCT02722434|182997122|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
91554585|NCT02722434|182997123|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Sensory Subscale||||0.79
91554586|NCT02722434|182997123|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Motor Subscale||||0.43
91554587|NCT02722434|182997123|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Autonomic Subscale||||0.97
91554588|NCT01128595|182997201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.515|||||TWO_SIDED|95.0|0.33|0.701||||||||0.701|0.330|
91554589|NCT01128595|182997201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|||||TWO_SIDED|95.0|0.355|0.73||||||||0.730|0.355|
91554590|NCT01128595|182997201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|||||TWO_SIDED|95.0|0.001|0.388||||||||0.388|0.001|
91554591|NCT01128595|182997201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|||||TWO_SIDED|95.0|-0.198|0.143||||||||0.143|-0.198|
91554592|NCT01128595|182997201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.14|0.501||||||||0.501|0.140|
91554593|NCT01128595|182997204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.332|0.636||||||||0.636|0.332|
91554594|NCT01128595|182997204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.33|0.638||||||||0.638|0.330|
91554595|NCT01128595|182997204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|||||TWO_SIDED|95.0|0.009|0.327||||||||0.327|0.009|
91554596|NCT01128595|182997204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.14|0.14||||||||0.140|-0.140|
91554597|NCT01128595|182997204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|||||TWO_SIDED|95.0|0.168|0.464||||||||0.464|0.168|
91554598|NCT01128595|182997205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|||||TWO_SIDED|95.0|0.031|0.393||||||||0.393|0.031|
91554599|NCT01128595|182997205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|||||TWO_SIDED|95.0|0.147|0.536||||||||0.536|0.147|
91554600|NCT01128595|182997205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477|||||TWO_SIDED|95.0|0.282|0.672||||||||0.672|0.282|
91554601|NCT01128595|182997205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|0.066|0.463||||||||0.463|0.066|
91554602|NCT01128595|182997205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||||TWO_SIDED|95.0|-0.072|0.343||||||||0.343|-0.072|
91554603|NCT01128595|182997206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.037|0.215||||||||0.215|-0.037|
91554604|NCT01128595|182997206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||||TWO_SIDED|95.0|0.101|0.371||||||||0.371|0.101|
91554605|NCT01128595|182997206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|||||TWO_SIDED|95.0|0.127|0.398||||||||0.398|0.127|
91554606|NCT01128595|182997206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|||||TWO_SIDED|95.0|0.036|0.312||||||||0.312|0.036|
91554607|NCT01128595|182997206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||||TWO_SIDED|95.0|-0.118|0.171||||||||0.171|-0.118|
91554608|NCT00336505|182997218|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|2.0||||0.5667|TWO_SIDED|95.0|-4.8|8.9|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||8.9|-4.8|0.5667
91554609|NCT00336505|182997220|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|0.3|||>|0.9999||95.0|-4.5|5.1|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||5.1|-4.5|>0.9999
91554610|NCT00366249|182997222|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railker|-5.5||||||95.0|-11.0|0.1|||||Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score|Analysis provided for Cure||0.1|-11.0|
91554611|NCT00366249|182997224|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.7||||||95.0|-12.3|-1.1|||||Adjusted for PEDIS score|Analysis provided for Cure||-1.1|-12.3|
91554612|NCT00366249|182997226|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.3||||||95.0|-13.6|1.0|||||Adjusted for PEDIS score|||1.0|-13.6|
91554613|NCT01185600|182997251|SUPERIORITY_OR_OTHER|||||||0.142|||||||Fisher Exact|||||||0.142
91554614|NCT01185600|182997252|SUPERIORITY_OR_OTHER|||||||0.0391|||||||Fisher Exact|||||||0.0391
91554615|NCT01185600|182997253|SUPERIORITY_OR_OTHER|||||||0.372|||||||Fisher Exact|||||||0.372
91554616|NCT01185600|182997254|SUPERIORITY_OR_OTHER|||||||0.1007|||||||t-test, 2 sided|||||||0.1007
91554617|NCT01185600|182997255|SUPERIORITY_OR_OTHER|||||||0.0964|||||||t-test, 2 sided|||||||0.0964
91554618|NCT01185600|182997256|SUPERIORITY_OR_OTHER|||||||0.1739|||||||t-test, 2 sided|||||||0.1739
91554619|NCT01185600|182997257|SUPERIORITY_OR_OTHER|||||||0.7205|||||||t-test, 1 sided|||||||0.7205
91554620|NCT01185600|182997258|SUPERIORITY_OR_OTHER||Negative Binomial|1.64||||0.0176|TWO_SIDED|95.0|1.06|2.55|||t-test, 2 sided||"Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:~(# of AE's, Unwashed Group / (# of AE's, Washed Group) = 1.64 95% C.I. = \[1.06 - 2.55\]"|||2.55|1.06|0.0176
91554621|NCT05405244|182997259|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Snack intake||||0.45
91554622|NCT05405244|182997259|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Milkshake intake||||0.28
91554623|NCT05405244|182997260|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Pleasantness||||0.89
91554624|NCT05405244|182997260|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Desire to consume||||<0.001
91554625|NCT03455985|182997281|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.09|TWO_SIDED||||||Regression, Linear|||||||0.09
91554626|NCT03455985|182997282|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
91554627|NCT03455985|182997283|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
91554628|NCT03455985|182997284|SUPERIORITY||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|30.3||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
91554629|NCT03280030|182997318|OTHER|Success criteria is considered based on point estimated Hazard ratio|Hazard Ratio, log|1.326|||||TWO_SIDED|95.0|0.624|2.818||||||||2.818|0.624|
91554630|NCT03275285|182997336|SUPERIORITY|For PFS, the nominal significance levels at primary analysis was determined using alpha-spending function in order to control overall 1-sided type 1 error at 2.5%. The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis (103 PFS events) was 0.005. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.531||||0.0007|TWO_SIDED|99.0|0.318|0.889||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.005.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.||0.889|0.318|0.0007
91554631|NCT03275285|182997337|SUPERIORITY|The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.548||||0.0016|TWO_SIDED|99.2|0.317|0.948||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.||0.948|0.317|0.0016
91554632|NCT03275285|182997338|SUPERIORITY||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.4|0.418|0.792|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.792|0.418|
91554633|NCT03275285|182997339|SUPERIORITY||Hazard Ratio (HR)|0.594|||||TWO_SIDED|95.4|0.424|0.832|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.832|0.424|
91554634|NCT03275285|182997340|SUPERIORITY|A closed test procedure was used to control the Type I error rate from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. No further testing would be performed unless the significance level had been reached on PFS and testing on subsequent endpoints were continued only if the null hypothesis for the previously tested endpoint was rejected.||||||0.193||||||One-sided p-value based on Stratified Cochran-Mantel-Haenszel test. Threshold for statistical significance level at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on randomization factors according to IRT.||Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.||||0.1930
91554635|NCT03275285|182997347|SUPERIORITY||Stratified Hazard Ratio|0.425|||||TWO_SIDED|95.0|0.269|0.672|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.672|0.269|
91554636|NCT03275285|182997348|SUPERIORITY||Stratified Hazard Ratio|0.495|||||TWO_SIDED|95.0|0.324|0.757|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.757|0.324|
91554637|NCT03275285|182997349|SUPERIORITY||Stratified Hazard Ratio|1.143|||||TWO_SIDED|95.0|0.888|1.471|||||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|1.471|0.888|
91554638|NCT03275285|182997350|SUPERIORITY||Stratified Hazard Ratio|0.955|||||TWO_SIDED|95.0|0.74|1.233|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||1.233|0.740|
91554639|NCT03275285|182997351|SUPERIORITY|\[Not specified\]|[Stratified Hazard Ratio]|0.683|||||TWO_SIDED|95.0|0.496|0.941|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.941|0.496|
91554640|NCT03275285|182997352|SUPERIORITY|\[Not specified\]|Stratified Hazard Ratio|0.663|||||TWO_SIDED|95.0|0.491|0.895|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.895|0.491|
91554641|NCT00115934|182997375|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-10.1||||0.013||95.0|-17.8|-2.4|||Fisher Exact||The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.|The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.||-2.4|-17.8|0.013
91554642|NCT00115934|182997376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Log Rank|||||||0.06
91554643|NCT00115934|182997377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
91554644|NCT00115934|182997378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.009
91554645|NCT00115934|182997379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
91554646|NCT00115934|182997380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
91554647|NCT00115934|182997381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test||||0.004
91554648|NCT00115934|182997382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
91554649|NCT00115934|182997383|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91554650|NCT00115934|182997384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
91554651|NCT00115934|182997385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
91554652|NCT00115934|182997386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||95.0|||||t-test, 2 sided|||||||0.54
91554653|NCT00115934|182997387|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91554654|NCT00115934|182997388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Poisson regression|The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.||||||0.003
91554655|NCT00115934|182997389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.20
91554656|NCT00115934|182997390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.002
91554657|NCT00115934|182997391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Poisson regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.03
91554658|NCT03400150|182997414|OTHER|||||||0.025|TWO_SIDED|95.0|||||Farrington-Manning|||||||0.025
91554659|NCT02278185|182997479|SUPERIORITY|||||||0.46|||||||Chi-squared|||The difference between metabolic syndrome and treatment were evaluated with the Chi-square test|This study did not meet it's target accrual goal and thus is underpowered to detect a statistically significant difference between the two groups.|||0.46
91554660|NCT02278185|182997479|SUPERIORITY|||||||0.46|||||||Chi-squared|||Cohort characteristics for Metabolic Syndrome were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|Cohort characteristics for Metabolic Syndrome, the SPPB, the SHIM/FACT-P, and PSA were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. The Wilcoxon signed-rank test was utilized to examine the difference between Month 1 and Month 12 SPPB scores. The Wilcoxon rank-sum test was used to assess the difference of SHIM/FACT-P scores and PSA between arms. These tests were chosen to account for the non-normal distributions of the continuous variables. The difference between PSA progression between arms was examined using the Fisher Exact Test. A heat map of scores ordered by the highest average score was also created. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|||0.46
91554661|NCT02278185|182997490|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||The results are presented in the following format: N Mean (Std Dev) Median (Q1, Q3). In all cases (Overall, Arm 1, and Arm 2) we fail to reject the null hypothesis that the samples come from the same population of scores at Month 1 versus Month 12 at the 0.05 significance level.||||0.5
91554662|NCT02866942|182997545|OTHER|||||||0.26|||||||McNemar|||||||0.26
91554663|NCT00372775|182997552|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|1.6|||||TWO_SIDED|95.0|0.0|8.8|||||Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution|||8.8|0.0|
91554664|NCT00372775|182997554|SUPERIORITY_OR_OTHER||ORR (percent)|4.3|||||TWO_SIDED|95.0|0.1|21.9|||||Two-Sided CI from Exact Method using the F Distribution|||21.9|0.1|
91554665|NCT00372775|182997557|SUPERIORITY_OR_OTHER||Percentage|23.4|||||TWO_SIDED|95.0|14.0|34.3|||||Probability of survival along with the corresponding 2-sided confidence interval for the log \[-log(one-year survival rate)\] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival|||34.3|14.0|
91554666|NCT01561300|182997566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.09|TWO_SIDED|95.0|-2.16|0.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.17|-2.16|0.09
91554667|NCT01561300|182997567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.7|TWO_SIDED|95.0|-2.44|1.66|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea- Control|Null hypothesis: no difference between Tea and Control.||1.66|-2.44|0.70
91554668|NCT01561300|182997568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.15|0.75||Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Mixed Models Analysis||Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.75|-1.15|0.66
91767881|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.001|TWO_SIDED|95.0|0.025|0.102|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.102|0.025|0.001
91767882|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.091|||<|0.001|TWO_SIDED|95.0|0.053|0.13|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|0.053|<0.001
91554669|NCT05230433|182997605|OTHER||Percent Consumed|86.0||||0.15|TWO_SIDED|||||p-value was not adjusted for multiple comparisons|Chi-squared|||High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \>75% of the shake.||||0.15
91554670|NCT05230433|182997606|OTHER|No test vs. control groups.||||||0.65||||||This p-value is not adjusted for multiple comparisons.|Pearson Correlation|||Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.|Pearson Correlation between both secondary outcomes reported: BMI percentile and fold change between acylcarnitine at 60 minutes and 180 minutes post the high fat challenge.|||0.65
91554671|NCT00754065|182997609|SUPERIORITY_OR_OTHER_LEGACY||F-statistic|9.3218||||0.0024||||||Comparison of EV/DNG vs. EE/NGM|ANOVA|||2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors||||0.0024
91554672|NCT04353492|182997728|OTHER|tested by a lower tailed test at 0.05 significance level|||||<|0.0001|||||||negative binomial regresion|||The null hypothesis (H0): ARR \>= 0.18||||<0.0001
91554673|NCT04250194|182997730|NON_INFERIORITY|The noninferiority margin was 10%.|absolute difference in percentage points|5.4||||0.003|TWO_SIDED|95.0|-6.5|17.2||The threshold for statistical significance was p = 0.05. The p value was not adjusted for multiple comparisons.|One-sided two-sample z-test||Difference in diagnostic accuracy = navigational bronchoscopy % - transthoracic biopsy %|||17.2|-6.5|0.003
91554674|NCT00857766|182997769|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.42||||0.065||95.0|-0.88|0.03|||ANCOVA||LS mean difference is calculated as FSC 250/50 minus Placebo and is adjusted for treatment, investigator, sex, smoking status, age, body mass index (BMI), waist circumference, treatment by sex interaction, age by BMI interaction, and baseline value.|||0.03|-0.88|0.065
91554675|NCT00857766|182997770|SUPERIORITY_OR_OTHER||Least squares analysis|-0.6|STANDARD_ERROR_OF_MEAN|0.86||0.469||95.0|-2.3|1.1|||ANCOVA|||||1.1|-2.3|0.469
91554676|NCT00857766|182997771|SUPERIORITY_OR_OTHER||Least squares analysis|127.0|STANDARD_ERROR_OF_MEAN|35.5|<|0.001||95.0|57.0|197.0|||ANCOVA|||||197|57|<0.001
91554677|NCT01961609|182997772|SUPERIORITY_OR_OTHER||Percentage|65.3|||<|0.0001|TWO_SIDED|99.375|52.4|76.7|||two-sided binomial exact test||A Bonferroni adjustment adjusting for 8 analyses have been applied.|||76.7|52.4|<0.0001
91554678|NCT01988402|182997789|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5
91554679|NCT00571649|182997803|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.771||||0.0211||95.0|0.618|0.962||Hochberg procedure: A 2-sided p-value of less than 0.05 would be considered significant, if the 1-sided p-value of the other primary efficacy outcome measure was less than 0.025, elsewise a p-value of less than 0.025 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (91.4% for superiority) with 4% event rate at day 35 for comparator and 40% relative risk reduction.||0.962|0.618|0.0211
91767883|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.012|TWO_SIDED|95.0|0.011|0.088|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.088|0.011|0.012
91767884|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.039|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|0.039|<0.001
91554680|NCT00571649|182997804|NON_INFERIORITY_OR_EQUIVALENCE|Rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI (Confidence Interval) was less than 1.5|Risk Ratio (RR)|0.968||||0.0025||95.0|0.713|1.314||Hochberg procedure: A 1-sided p-value of less than 0.025 would be considered significant, if the 2-sided p-value of the other primary efficacy outcome measure was less than 0.05, elsewise a p-value of less than 0.0125 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (98.6% power for non-inferiority) with 1.8% event rate at day 10 for comparator and 35% relative risk reduction.||1.314|0.713|0.0025
91554681|NCT00571649|182997805|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.931||||0.3758||95.0|0.795|1.091||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the two primary efficacy outcome measures were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.091|0.795|0.3758
91554682|NCT00571649|182997806|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.991||||0.9473||95.0|0.753|1.304||"Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the 2 primary efficacy outcomes and for Composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days were significant."|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.304|0.753|0.9473
91767885|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.157|TWO_SIDED|95.0|-0.011|0.066|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.066|-0.011|0.157
91767886|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.021|TWO_SIDED|95.0|0.011|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.011|0.021
91767887|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.053|0.17|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.053|<0.001
91767888|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.103|0.22|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.220|0.103|<0.001
91767889|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.099|0.215|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.215|0.099|<0.001
91767890|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.154|0.271|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.271|0.154|<0.001
91767891|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.149|TWO_SIDED|95.0|-0.015|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.015|0.149
91767892|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.002|TWO_SIDED|95.0|0.034|0.151|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.151|0.034|0.002
91767893|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.003|TWO_SIDED|95.0|0.031|0.146|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.031|0.003
91767894|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.096|TWO_SIDED|95.0|-0.009|0.108|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|-0.009|0.096
91767895|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.122|TWO_SIDED|95.0|-0.012|0.103|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.103|-0.012|0.122
91767896|NCT03084796|183425142|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.886|TWO_SIDED|95.0|-0.062|0.054|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.054|-0.062|0.886
91554683|NCT00571649|182997815|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.455|||<|0.0001|TWO_SIDED|95.0|1.854|3.251||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||There was no sample size estimation as this was not planed as confirmatory analysis||3.251|1.854|<0.0001
91554684|NCT00571649|182997816|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.272|||<|0.0001|TWO_SIDED|95.0|1.628|3.171||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|||There was no sample size estimation as this was not planed as confirmatory analysis||3.171|1.628|<0.0001
91554685|NCT02397096|182997822|NON_INFERIORITY|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-3.784|||||TWO_SIDED|95.0|-7.877|0.31|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|0.310|-7.877|
91554686|NCT02397096|182997823|OTHER||Treatment Difference|-14.65|||<|0.0001|TWO_SIDED|95.0|-18.92|-10.38|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-10.38|-18.92|<0.0001
91554687|NCT02397096|182997824|OTHER||Treatment Difference|-23.03|||<|0.0001|TWO_SIDED|95.0|-28.0|-18.05|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-18.05|-28.00|<0.0001
91554688|NCT02397096|182997825|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-0.877|||||TWO_SIDED|95.0|-4.706|2.952|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|2.952|-4.706|
91554689|NCT02397096|182997826|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-31.6|23.5|||||95% CIs were calculated based on t-distribution.|||23.5|-31.6|
91767897|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.029|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.141|0.008|0.029
91554690|NCT02397096|182997827|SUPERIORITY||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-41.1|15.4|||||95% Confidence Intervals were based on t-distribution.|||15.4|-41.1|
91554691|NCT02397096|182997828|OTHER||Treatment Difference|-3.556|||||TWO_SIDED|95.0|-7.977|0.864|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||0.864|-7.977|
91554692|NCT02397096|182997829|OTHER||Treatment Difference|-0.427|||||TWO_SIDED|95.0|-4.591|3.738|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||3.738|-4.591|
91554693|NCT02397096|182997830|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.|Treatment Difference|-0.232|||||TWO_SIDED|95.0|-2.529|2.064|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||2.064|-2.529|
91554694|NCT03500549|182997836|SUPERIORITY|The primary endpoint analysis was a between-treatment-group comparison using a mixed effect model for repeated measures (MMRM). The difference between pegcetacoplan and eculizumab LS mean Hb changes from Baseline at Week 16 was calculated along with its 2-sided 95% confidence interval (CI) and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|3.84|||<|0.0001|TWO_SIDED|95.0|2.33|5.34||Superiority was tested at the 5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||5.34|2.33|<0.0001
91554695|NCT03500549|182997837|NON_INFERIORITY|Analysis was based on prespecified non-inferiority margins (NIM) and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of -20%. Stratified Cochran-Mantel Haenszel (CMH) chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified (Miettinen-Nurminen) method.|Risk Difference (RD)|0.6253|||<|0.0001|TWO_SIDED|95.0|0.483|0.7677||Non-inferiority was tested at the 2.5% level.|Miettinen-Nurminen|||||0.7677|0.4830|<0.0001
91554696|NCT03500549|182997838|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 10.|LS mean difference|-163.61|||<|0.0001|TWO_SIDED|95.0|-189.91|-137.3||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-137.30|-189.91|<0.0001
91554697|NCT03500549|182997839|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 20.|LS mean difference|-4.63||||0.9557|TWO_SIDED|95.0|-181.3|172.04||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||172.04|-181.30|0.9557
91554698|NCT03500549|182997840|OTHER|Non-inferiority was not assessed because of the prespecified hierarchical testing. Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.87||||0.0005|TWO_SIDED|95.0|5.49|18.25||MRMM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||18.25|5.49|0.0005
91554699|NCT03500549|182997841|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6745|||||TWO_SIDED|95.0|0.5452|0.8039|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.8039|0.5452|
91554700|NCT03500549|182997842|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6639|||||TWO_SIDED|95.0|0.5309|0.7968|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.7968|0.5309|
91554701|NCT03500549|182997843|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.3043|||||TWO_SIDED|95.0|0.1493|0.4593|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.4593|0.1493|
91554702|NCT03500549|182997844|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-21.93||||0.0002|TWO_SIDED|95.0|-32.49|-11.36||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-11.36|-32.49|0.0002
91554703|NCT03500549|182997845|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.14||||0.0369|TWO_SIDED|95.0|-0.28|-0.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-0.01|-0.28|0.0369
91767898|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.055|0.188|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.188|0.055|<0.001
91767899|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.117|0.25|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.250|0.117|<0.001
91554704|NCT03500549|182997846|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|59.1||||0.0069|TWO_SIDED|95.0|16.88|101.32||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||101.32|16.88|0.0069
91554705|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|18.62||||0.0486|TWO_SIDED|95.0|0.12|37.13||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Global Health Status/QoL: Difference in LS mean||37.13|0.12|0.0486
91554706|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|12.86||||0.0023|TWO_SIDED|95.0|4.86|20.86||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Physical functioning: Difference in LS mean||20.86|4.86|0.0023
91554707|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|24.43||||0.0027|TWO_SIDED|95.0|8.84|40.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Role functioning: Difference in LS mean||40.01|8.84|0.0027
91767900|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.142|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.142|<0.001
91767901|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.227|0.36|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.360|0.227|<0.001
91767902|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.161|TWO_SIDED|95.0|-0.019|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|-0.019|0.161
91554708|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|4.11||||0.6013|TWO_SIDED|95.0|-11.58|19.8||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Emotional functioning: Difference in LS mean||19.80|-11.58|0.6013
91554709|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|9.56||||0.1792|TWO_SIDED|95.0|-4.52|23.64||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Cognitive functioning: Difference in LS mean||23.64|-4.52|0.1792
91554710|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.27||||0.1039|TWO_SIDED|95.0|-2.38|24.92||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Social functioning: Difference in LS mean||24.92|-2.38|0.1039
91767903|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.001|TWO_SIDED|95.0|0.043|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.043|0.001
91767904|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.068|0.201|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.201|0.068|<0.001
91767905|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.066|TWO_SIDED|95.0|-0.004|0.128|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.004|0.066
91767906|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|0.021|0.010
91554711|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-20.74||||0.0062|TWO_SIDED|95.0|-35.29|-6.19||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Fatigue: Difference in LS mean||-6.19|-35.29|0.0062
91554712|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.01||||0.9975|TWO_SIDED|95.0|-8.38|8.35||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Nausea and vomiting: Difference in LS mean||8.35|-8.38|0.9975
91767907|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.465|TWO_SIDED|95.0|-0.042|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.042|0.465
91767908|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.008|TWO_SIDED|95.0|0.03|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.030|0.008
91767909|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.091|0.256|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.256|0.091|<0.001
91767910|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.219|||<|0.001|TWO_SIDED|95.0|0.136|0.302|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.136|<0.001
91767911|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.131|0.295|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.295|0.131|<0.001
91767912|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.326|||<|0.001|TWO_SIDED|95.0|0.244|0.409|||McNemar|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.409|0.244|<0.001
91554713|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-2.76||||0.7554|TWO_SIDED|95.0|-20.36|14.85||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Pain: Difference in LS mean||14.85|-20.36|0.7554
91554714|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-14.57||||0.062|TWO_SIDED|95.0|-29.9|0.76||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Dyspnoea: Difference in LS mean||0.76|-29.90|0.0620
91767913|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.144|TWO_SIDED|95.0|-0.021|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.021|0.144
91767914|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.107||||0.011|TWO_SIDED|95.0|0.024|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.024|0.011
91767915|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.016|TWO_SIDED|95.0|0.019|0.182|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.182|0.019|0.016
91767916|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.28|TWO_SIDED|95.0|-0.037|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.037|0.280
91554715|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|0.32||||0.9686|TWO_SIDED|95.0|-15.67|16.3||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Insomnia: Difference in LS mean||16.30|-15.67|0.9686
91767917|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.342|TWO_SIDED|95.0|-0.042|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|-0.042|0.342
91767918|NCT03084796|183425143|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.886|TWO_SIDED|95.0|-0.088|0.076|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.076|-0.088|0.886
91767919|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.003|TWO_SIDED|95.0|0.032|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.163|0.032|0.003
91767920|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.156|||<|0.001|TWO_SIDED|95.0|0.091|0.221|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.221|0.091|<0.001
91767921|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.143|0.273|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.273|0.143|<0.001
91767922|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.237|||<|0.001|TWO_SIDED|95.0|0.172|0.302|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.172|<0.001
91767923|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.276|||<|0.001|TWO_SIDED|95.0|0.211|0.341|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.341|0.211|<0.001
91767924|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.076|TWO_SIDED|95.0|-0.006|0.124|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.124|-0.006|0.076
91767925|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.046|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.046|<0.001
91767926|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.075|0.205|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.205|0.075|<0.001
91767927|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.116|TWO_SIDED|95.0|-0.013|0.117|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.117|-0.013|0.116
91767928|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.014|TWO_SIDED|95.0|0.016|0.146|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.016|0.014
91767929|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.384|TWO_SIDED|95.0|-0.036|0.094|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.094|-0.036|0.384
91767930|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.236|0.064|<0.001
91767931|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.118|0.29|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.290|0.118|<0.001
91767932|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.248|||<|0.001|TWO_SIDED|95.0|0.162|0.335|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.335|0.162|<0.001
91767933|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.254|||<|0.001|TWO_SIDED|95.0|0.168|0.339|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.339|0.168|<0.001
91767934|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.354|||<|0.001|TWO_SIDED|95.0|0.268|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.268|<0.001
91767935|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.214|TWO_SIDED|95.0|-0.031|0.14|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.140|-0.031|0.214
91767936|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.025|TWO_SIDED|95.0|0.012|0.184|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|0.012|0.025
91767937|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.016|TWO_SIDED|95.0|0.019|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.019|0.016
91767938|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.313|TWO_SIDED|95.0|-0.042|0.13|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|-0.042|0.313
91767939|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.25|TWO_SIDED|95.0|-0.035|0.135|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.135|-0.035|0.250
91767940|NCT03084796|183425144|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.898|TWO_SIDED|95.0|-0.08|0.091|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.080|0.898
91767941|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.006|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.153|0.006|0.035
91767942|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.085|0.232|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.085|<0.001
91767943|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.201|||<|0.001|TWO_SIDED|95.0|0.127|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.127|<0.001
91554716|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.95||||0.3002|TWO_SIDED|95.0|-23.23|7.33||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Appetite loss: Difference in LS mean||7.33|-23.23|0.3002
91554717|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|1.79||||0.8374|TWO_SIDED|95.0|-15.7|19.29||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Constipation: Difference in LS mean||19.29|-15.70|0.8374
91554718|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-1.38||||0.8775|TWO_SIDED|95.0|-19.28|16.52||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Diarrhoea: Difference in LS mean||16.52|-19.28|0.8775
91554719|NCT03500549|182997847|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.4||||0.3066|TWO_SIDED|95.0|-21.76|6.95||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Financial difficulties: Difference in LS mean||6.95|-21.76|0.3066
91554720|NCT03500549|182997848|OTHER|Wilcoxon rank-sum test P-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% CI is constructed using Hodges-Lehmann Estimation of Location Shift.|Median Difference (Final Values)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0|||Wilcoxon rank-sum test|||||4.0|2.0|<0.0001
91554721|NCT06688357|182997869|SUPERIORITY||Cohen's d|0.99||||0.077|TWO_SIDED|||||t (13) = 1.920. Only 1 comparison with 2 means, thus no adjustment necessary|t-test, 2 sided|||Independent sample t-test conducted to examine difference in pre-post intervention change scores for the active vs sham intervention groups. Cohen's d was calculated to determine effect size.||||.077
91554722|NCT06688357|182997870|SUPERIORITY||Cohen's D|0.779||||0.159|TWO_SIDED|||||t(13) = 1.504; only 1 comparison of 2 values, thus no adjustment is necessary|t-test, 2 sided|||independent sample t-test; Cohen's d effect size||||.159
91554723|NCT06688357|182997871|SUPERIORITY||Cohen's D|0.356||||0.503|TWO_SIDED|||||t (13) = 0.688; only 1 comparison, adjustment not necessary|t-test, 2 sided|df = 13||independent samples t-test, cohen's d effect size||||.503
91554724|NCT06688357|182997872|SUPERIORITY||Cohen's D|-0.922||||0.08|TWO_SIDED|||||t(13) = 1.893; only one comparison of 2 scores, thus no adjustment for multiple comparisons was necessary|t-test, 2 sided|df = 13||Independent sample t-test used to examine pre-post intervention change scores in active vs sham groups; Cohen's d was calculated to estimate effect size||||0.08
91554725|NCT06688357|182997873|SUPERIORITY||Cohen's D|0.793||||0.149|TWO_SIDED|||||t (13) = 1.533; only 1 comparison, no adjustment necessary|t-test, 2 sided|||independent sample t-test, Cohen d effect size||||.149
91554726|NCT06688357|182997874|SUPERIORITY||Cohen's D|0.905||||0.104|TWO_SIDED|||||t(13) = 1.749; only 1 comparison with 2 values, thus no adjustment for multiple comparisons|t-test, 2 sided|df = 13||independent sample t-test was used to examine difference in Post-Pre intervention change in the Active vs the Sham groups; Effect size was estimated using Cohen's d.||||.104
91554727|NCT06688357|182997875|SUPERIORITY||Cohen's D|-0.267||||0.614|TWO_SIDED|||||t(13) = -.516; only 1 comparison of 2 means, no adjustment needed|t-test, 2 sided|||independent sample t-tests examining Post-Baseline differences for the Active vs the Sham groups; Effect size computed using Cohen's d score||||.614
91554728|NCT06688357|182997876|SUPERIORITY||Cohen's D|0.652||||0.23|TWO_SIDED|||||t(13) = -1.260; only 1 comparison of 2 values, no need for adjustment|t-test, 2 sided|||independent samples t-test, effect size computation (cohen's d)||||.230
91554729|NCT04440228|182997941|SUPERIORITY|||||||0.088||||||Assumptions of ANOVA were violated, so we conducted a Related-Samples Friedman's Two-Way Analysis of Variance by Ranks|ANOVA|F=6.54, df=3||Repeated measures ANOVA examining change over time across the three partner school districts.||||0.088
91767944|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.168|0.315|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.315|0.168|<0.001
91767945|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.277|||<|0.001|TWO_SIDED|95.0|0.204|0.351|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.351|0.204|<0.001
91767946|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.005|0.152|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.152|0.005|0.035
91767947|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.121||||0.001|TWO_SIDED|95.0|0.048|0.195|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.048|0.001
91767948|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.088|0.235|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.088|<0.001
91767949|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.256|TWO_SIDED|95.0|-0.031|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|-0.031|0.256
91767950|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.027|TWO_SIDED|95.0|0.01|0.156|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.156|0.010|0.027
91767951|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.281|TWO_SIDED|95.0|-0.033|0.114|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.114|-0.033|0.281
91767952|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.003|TWO_SIDED|95.0|0.05|0.232|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.050|0.003
91767953|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.197|||<|0.001|TWO_SIDED|95.0|0.106|0.288|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.288|0.106|<0.001
91767954|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.249|||<|0.001|TWO_SIDED|95.0|0.157|0.34|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.340|0.157|<0.001
91767955|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.245|||<|0.001|TWO_SIDED|95.0|0.155|0.336|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.336|0.155|<0.001
91767956|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.348|||<|0.001|TWO_SIDED|95.0|0.258|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.258|<0.001
91767957|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.222|TWO_SIDED|95.0|-0.034|0.147|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.147|-0.034|0.222
91767958|NCT03084796|183425145|SUPERIORITY||Hazard Ratio, log|0.108||||0.02|TWO_SIDED|95.0|0.017|0.199|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.199|0.017|0.020
91767959|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.022|TWO_SIDED|95.0|0.015|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.015|0.022
91767960|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.262|TWO_SIDED|95.0|-0.039|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.039|0.262
91767961|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.29|TWO_SIDED|95.0|-0.041|0.138|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.041|0.290
91554730|NCT04440228|182997942|SUPERIORITY||Mean Difference (Final Values)|0.204|||<|0.05|TWO_SIDED|95.0|0.036|0.373|||Regression, Linear|||We conducted paired t-tests to evaluate simple pre-to-post changes in the primary outcome measures. We fitted linear mixed-effects regression models for each outcome variable, specifying random intercepts for participant ID to account for repeated measures and within-individual clustering. The core model included a binary post-training indicator as the primary predictor, along with the baseline value of the corresponding outcome as a covariate.||0.373|0.036|<0.05
91554731|NCT04440228|182997943|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.277|TWO_SIDED|95.0|-0.064|0.219|||Regression, Linear|||We conducted paired t-tests to evaluate simple pre-to-post changes in the primary outcome measures. We fitted linear mixed-effects regression models for each outcome variable, specifying random intercepts for participant ID to account for repeated measures and within-individual clustering. The core model included a binary post-training indicator as the primary predictor, along with the baseline value of the corresponding outcome as a covariate.||0.219|-0.064|.277
91554732|NCT04440228|182997944|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.996|TWO_SIDED|95.0|-0.082|0.083|||Regression, Linear|||We conducted paired t-tests to evaluate simple pre-to-post changes in the primary outcome measures. We fitted linear mixed-effects regression models for each outcome variable, specifying random intercepts for participant ID to account for repeated measures and within-individual clustering. The core model included a binary post-training indicator as the primary predictor, along with the baseline value of the corresponding outcome as a covariate.||0.083|-0.082|0.996
91554733|NCT04503681|182997962|SUPERIORITY||Median Difference (Final Values)|0.0||||0.473|TWO_SIDED|95.0|-1.1|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|-1.1|0.473
91554734|NCT04503681|182997963|SUPERIORITY||Median Difference (Final Values)|0.0||||0.338|TWO_SIDED|95.0|-0.8|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.8|0.338
91767962|NCT03084796|183425145|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.938|TWO_SIDED|95.0|-0.094|0.087|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.087|-0.094|0.938
91767963|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.21|2.24|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using Cox proportional hazards model, including treatment, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and baseline FEV1 value as covariate."||2.24|1.21|0.002
91767964|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|2.18|||<|0.001|TWO_SIDED|95.0|1.61|2.94|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.94|1.61|<0.001
91767965|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|2.79|||<|0.001|TWO_SIDED|95.0|2.07|3.78|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.78|2.07|<0.001
91767966|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|3.07|||<|0.001|TWO_SIDED|95.0|2.27|4.15|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.15|2.27|<0.001
91767967|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.17|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.17|2.30|<0.001
91554735|NCT03442777|182997985|SUPERIORITY||Risk Ratio (RR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.99||controlled for type of ward (ICU/Non-ICU)|Cochran-Mantel-Haenszel|||||0.99|0.41|0.04
91554736|NCT00724126|182998031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.03
91554737|NCT00724126|182998032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.02
91554738|NCT03577106|182998036|OTHER||||||<|0.005||||||t(20)=3.3, p\<0.005|paired t-test|||Mean difference using a paired t-test||||<0.005
91767968|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.052|TWO_SIDED|95.0|1.0|1.76|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.76|1.00|0.052
91767969|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.26|1.28|<0.001
91554739|NCT03601715|182998054|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
91554740|NCT03601715|182998055|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
91554741|NCT03601715|182998056|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
91554742|NCT01478594|182998060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.706|TWO_SIDED|95.0|0.693|1.718|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O'Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.||1.718|0.693|0.706
91554743|NCT01478594|182998062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.116||||0.754|TWO_SIDED|95.0|0.561|2.218|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||2.218|0.561|0.754
91554744|NCT01478594|182998063|SUPERIORITY_OR_OTHER|||||||0.718|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).||||||0.718
91554745|NCT01478594|182998064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.389||||0.437|TWO_SIDED|95.0|0.604|3.194|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||3.194|0.604|0.437
91767970|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.87|||<|0.001|TWO_SIDED|95.0|1.41|2.48|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.48|1.41|<0.001
91767971|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.074|TWO_SIDED|95.0|0.98|1.69|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.69|0.98|0.074
91767972|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.013|TWO_SIDED|95.0|1.08|1.85|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.85|1.08|0.013
91767973|NCT03084796|183425146|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.494|TWO_SIDED|95.0|0.84|1.44|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.44|0.84|0.494
91767974|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.017|TWO_SIDED|95.0|0.011|0.107|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.107|0.011|0.017
91767975|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.001|TWO_SIDED|95.0|0.032|0.128|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.032|0.001
91767976|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
91767977|NCT03084796|183425148|SUPERIORITY||Hazard Ratio, log|0.111|||<|0.001|TWO_SIDED|95.0|0.063|0.159|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.159|0.063|<0.001
91767978|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
91554746|NCT01478594|182998065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.967|TWO_SIDED|95.0|0.746|1.358|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||1.358|0.746|0.967
91554747|NCT01478594|182998068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.331|||||TWO_SIDED|95.0|0.746|2.375|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.375|0.746|
91554748|NCT01478594|182998068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.575|||||TWO_SIDED|95.0|0.285|1.16|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.160|0.285|
91554749|NCT01478594|182998069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.608|||||TWO_SIDED|95.0|0.635|4.073|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.073|0.635|
91554750|NCT01478594|182998069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755|||||TWO_SIDED|95.0|0.375|1.521|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.521|0.375|
91554751|NCT01478594|182998070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.366|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.366|
91554752|NCT01478594|182998070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.275|||||TWO_SIDED|95.0|0.614|2.646|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.646|0.614|
91554753|NCT01478594|182998071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.345|1.507|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.507|0.345|
91554754|NCT01478594|182998071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.597|||||TWO_SIDED|95.0|0.672|3.795|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.795|0.672|
91554755|NCT01478594|182998072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.627|||||TWO_SIDED|95.0|0.58|4.564|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.564|0.580|
91554756|NCT01478594|182998072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779|||||TWO_SIDED|95.0|0.397|1.531|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.531|0.397|
91554757|NCT01478594|182998073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.946|||||TWO_SIDED|95.0|0.636|5.956|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||5.956|0.636|
91554758|NCT01478594|182998073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806|||||TWO_SIDED|95.0|0.422|1.538|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.538|0.422|
91554759|NCT01478594|182998074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776|||||TWO_SIDED|95.0|0.303|1.991|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.991|0.303|
91554760|NCT01478594|182998074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.615|2.501|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.501|0.615|
91554761|NCT01478594|182998075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.343|2.63|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.630|0.343|
91554762|NCT01478594|182998075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983|||||TWO_SIDED|95.0|0.503|1.918|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.918|0.503|
91554763|NCT01478594|182998076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.226|||||TWO_SIDED|95.0|0.468|3.214|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.214|0.468|
91554764|NCT01478594|182998076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232|||||TWO_SIDED|95.0|0.447|3.396|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.396|0.447|
91554765|NCT01478594|182998077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|||||TWO_SIDED|95.0|0.307|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.307|
91554766|NCT01478594|182998077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.505|||||TWO_SIDED|95.0|0.585|3.873|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.873|0.585|
91554767|NCT01478594|182998078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.356|2.385|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.385|0.356|
91554768|NCT01478594|182998078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.462|3.22|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.220|0.462|
91554769|NCT01478594|182998079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.334|2.512|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.512|0.334|
91554770|NCT01478594|182998079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.384|||||TWO_SIDED|95.0|0.554|3.455|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.455|0.554|
91554771|NCT01478594|182998080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.538|||||TWO_SIDED|95.0|0.548|4.32|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.320|0.548|
91554772|NCT01478594|182998080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|||||TWO_SIDED|95.0|0.299|1.85|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.850|0.299|
91554773|NCT01970007|182998083|OTHER||Freedom from MAE rate (%)|96.7|||<|0.0001|TWO_SIDED|95.0|93.5|98.6|||One-sided Exact binomial test||One-sided Exact binomial test|||98.6|93.5|<0.0001
91554774|NCT01970007|182998084|OTHER||12-month quantitative patency rate (%)|89.9|||<|0.0001|TWO_SIDED|95.0|85.1|93.4|||Binomial test for one proportion||Binomial test for one proportion|||93.4|85.1|<0.0001
91554775|NCT01970007|182998085|OTHER||Change from Baseline Mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.6||P-value is adjusted for multiplicity|paired t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05.||||-2.6|-3.5|<0.0001
91767979|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.377|TWO_SIDED|95.0|-0.026|0.069|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.069|-0.026|0.377
91554776|NCT01970007|182998086|OTHER||Change from Baseline Mean|-4.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.7||p-value is adjusted for multiplicity.|pair t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05||||-3.7|-4.7|<0.0001
91554777|NCT01759862|182998112|SUPERIORITY|Our calculations showed that by enrolling 50 patients we will be able to detect a 25cc/min absolute difference in eGFR between the two arms with power above 80%, and a two-sided Type I probability error of \<0.05.||||||0.32|||||||t-test, 2 sided|||Intention to treat analysis||||0.32
91554778|NCT01759862|182998113|SUPERIORITY|Enrolling 25 patients in each group will allow us to detect a difference of 200ng/mg cr in urinary NGAL levels between the two groups with a power of 80% and a two-sided type I probability error of 0.05.||||||0.95|||||||Kruskal-Wallis|||||||0.95
91554779|NCT01759862|182998114|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
91554780|NCT01499849|182998119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.7||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.7|1.3|<0.001
91554781|NCT01499849|182998120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.005|TWO_SIDED|95.0|1.2|2.8||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.8|1.2|0.005
91554782|NCT01499849|182998121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.001|TWO_SIDED|95.0|1.3|2.6||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.6|1.3|0.001
91554783|NCT02646618|182998123|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|2.0||||0.0038|TWO_SIDED|95.0|0.6|3.3|||Mixed Models Analysis|||||3.3|0.6|0.0038
91554784|NCT02646618|182998124|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|1.2||||0.1485|TWO_SIDED|95.0|-0.4|2.8|||Mixed Models Analysis|||||2.8|-0.4|0.1485
91554785|NCT02646618|182998126|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.2480
91554786|NCT02646618|182998131|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|93.0||||0.2025|TWO_SIDED|95.0|-50.0|237.0|||Mixed Models Analysis|||||237|-50|0.2025
91554787|NCT02646618|182998132|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|-75.0||||0.3323|TWO_SIDED|95.0|-226.0|77.0|||Mixed Models Analysis|||||77|-226|0.3323
91554788|NCT02646618|182998134|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.3905|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.3905
91554789|NCT02646618|182998135|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.4741|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.4741
91554790|NCT03885232|182998171|SUPERIORITY|We applied a mixed zero-inflated beta regression model that included a fixed binary factor for treatment arm, a random effect for clinic to account for correlation within clinics, and unbalanced parent demographics across study arms.|Incidence Rate Ratio (IRR)|1.04||||0.9|TWO_SIDED|95.0|0.68|1.6|||Generalized linear mixed effects regress|Generalized linear mixed effects regression models||||1.60|0.68|0.9
91554791|NCT03885232|182998172|SUPERIORITY||Other|1.0|||<|0.05|TWO_SIDED||||||Chi-squared|||Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \> or equal to 6; 0 = mean \< 6.||||<0.05
91767980|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.01|TWO_SIDED|95.0|0.015|0.111|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.111|0.015|0.010
91767981|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.031|TWO_SIDED|95.0|0.005|0.1|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.100|0.005|0.031
91767982|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.085|TWO_SIDED|95.0|-0.006|0.089|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.089|-0.006|0.085
91767983|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.199|TWO_SIDED|95.0|-0.016|0.079|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.079|-0.016|0.199
91767984|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.657|TWO_SIDED|95.0|-0.058|0.037|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.037|-0.058|0.657
91767985|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.246|TWO_SIDED|95.0|-0.022|0.086|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.086|-0.022|0.246
91767986|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.046|0.154|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.154|0.046|<0.001
91554792|NCT03885232|182998173|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.05|TWO_SIDED|95.0|0.66|5.64|||Generalized linear mixed effects regress|Adjusted for: study arm, study period (pre vs. post), years in practice, provider type, interaction between study arm and study period||"1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.~2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control."||5.64|0.66|<0.05
91554793|NCT05601882|182998179|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.6|15.5|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||15.5|6.6|<0.0001
91554794|NCT05601882|182998180|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.4|||<|0.0001|TWO_SIDED|95.0|12.5|24.2|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||24.2|12.5|<0.0001
91554795|NCT05601882|182998181|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.7|||<|0.0001|TWO_SIDED|95.0|9.4|20.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||20.0|9.4|<0.0001
91554796|NCT05601882|182998182|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|16.6|||<|0.0001|TWO_SIDED|95.0|10.2|23.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.0|10.2|<0.0001
91554797|NCT05601882|182998183|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|9.6|16.9|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||16.9|9.6|<0.0001
91554798|NCT05601882|182998184|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|6.4|||<|0.0001|TWO_SIDED|95.0|3.8|9.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||9.1|3.8|<0.0001
91554799|NCT05601882|182998185|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.4|18.8|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||18.8|9.4|<0.0001
91554800|NCT05601882|182998186|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.6|||<|0.0001|TWO_SIDED|95.0|13.9|23.3|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.3|13.9|<0.0001
91767987|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.119|||<|0.001|TWO_SIDED|95.0|0.064|0.173|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.173|0.064|<0.001
91554801|NCT05601882|182998187|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.4|13.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||13.1|5.4|<0.0001
91554802|NCT05501600|182998236|SUPERIORITY|||||||0.004|||||||Regression, Linear|||||||0.004
91554803|NCT05501600|182998237|SUPERIORITY|||||||0.081616|||||||t-test, 2 sided|||||||0.081616
91554804|NCT00227266|182998250|SUPERIORITY_OR_OTHER_LEGACY||Spearman's correlation|0.93|||<|0.001|||||||Spearman's correlation|||MHFMS-Extend was not normally distributed at p=0.048. Test-retest reliability of MHFMS-Extend measurements from the first (S1) to the second (S2) screening visit was analyzed using Spearman's correlation.||||<0.001
91554805|NCT05890794|182998259|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|40.85||||0.0005|TWO_SIDED|95.0|22.842|58.858||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PPi.||58.858|22.842|0.0005
91554806|NCT05890794|182998259|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error|Difference in LS Means|-11.17|STANDARD_ERROR_OF_MEAN|2.681|<|0.0001|TWO_SIDED|95.0|-16.52|-5.82||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by a mixed model repeated measures (MMRM) analysis for PPi.||-5.82|-16.52|<0.0001
91554807|NCT05890794|182998260|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|30.89|||<|0.0001|TWO_SIDED|95.0|20.831|40.941||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PLP.||40.941|20.831|<0.0001
91767988|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.088|0.196|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.196|0.088|<0.001
91554808|NCT05890794|182998260|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-22.51|STANDARD_ERROR_OF_MEAN|6.289||0.0024|TWO_SIDED|95.0|-35.81|-9.2||Significant test: two-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PLP.||-9.20|-35.81|0.0024
91554809|NCT05890794|182998261|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-4335.66||||0.0019|TWO_SIDED|95.0|-6652.753|-2018.576||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for ALP activity.||-2018.576|-6652.753|0.0019
91554810|NCT05890794|182998262|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|23.25||||0.0693|TWO_SIDED|95.0|-2.319|48.812||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for urine PEA.||48.812|-2.319|0.0693
91554811|NCT05890794|182998262|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-8.76|STANDARD_ERROR_OF_MEAN|22.986||0.7086|TWO_SIDED|95.0|-57.88|40.35||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for urine PEA.||40.35|-57.88|0.7086
91554812|NCT05890794|182998263|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|187.43||||0.0199|TWO_SIDED|95.0|36.516|338.344||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL.||338.344|36.516|0.0199
91554813|NCT05890794|182998263|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-12.51|STANDARD_ERROR_OF_MEAN|9.767||0.2034|TWO_SIDED|95.0|-31.92|6.89||Significant test: 2-sided; significance level 5%|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PL.||6.89|-31.92|0.2034
91554814|NCT05890794|182998264|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-0.89||||0.5195|TWO_SIDED|95.0|-3.868|2.084||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in fold change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL/PLP ratio.||2.084|-3.868|0.5195
91554815|NCT05890794|182998264|OTHER|The difference between LS Means of fold change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|1.01|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|0.69|1.33||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in fold change form baseline (LS Means) between dose levels of ilofotase alfa by an MMRM analysis for PL/PLP ratio.||1.33|0.69|<0.0001
91554816|NCT04538352|182998266|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.||||||0.009||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||0.009
91767989|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.07|0.178|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.178|0.070|<0.001
91767990|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.014|TWO_SIDED|95.0|0.014|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|0.014|0.014
91767991|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.002|TWO_SIDED|95.0|0.032|0.141|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.141|0.032|0.002
91767992|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.163|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.057|<0.001
91554817|NCT04538352|182998267|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.|||||<|0.001||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||<0.001
91554818|NCT03301467|182998272|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.967|TWO_SIDED|95.0|-1.9|1.8|||ANCOVA|||||1.8|-1.9|0.9670
91554819|NCT03301467|182998273|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.3083|TWO_SIDED||||||Van Elteren's Test||"Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.~SAP=Statistical Analysis Protocol"|||||0.3083
91554820|NCT03301467|182998274|SUPERIORITY|||||||0.4591|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.4591
91554821|NCT03301467|182998275|SUPERIORITY|||||||0.3106|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.3106
91554822|NCT03301467|182998276|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.3368|TWO_SIDED|95.0|-1.5|0.5|||ANCOVA|||||0.5|-1.5|0.3368
91554823|NCT03301467|182998277|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0401|TWO_SIDED|95.0|-1.7|0.0|||ANCOVA|||||-0.0|-1.7|0.0401
91767993|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.493|TWO_SIDED|95.0|-0.035|0.073|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.073|-0.035|0.493
91767994|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.119|TWO_SIDED|95.0|-0.011|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.011|0.119
91767995|NCT03084796|183425148|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.392|TWO_SIDED|95.0|-0.03|0.077|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.030|0.392
91767996|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.023|TWO_SIDED|95.0|0.015|0.203|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.203|0.015|0.023
91767997|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.058|TWO_SIDED|95.0|-0.003|0.184|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|-0.003|0.058
91767998|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.215|TWO_SIDED|95.0|-0.035|0.153|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|-0.035|0.215
91554824|NCT03301467|182998278|SUPERIORITY||Mean Difference (Final Values)|10.84||||0.0534|TWO_SIDED|95.0|-0.16|21.85|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||21.85|-0.16|0.0534
91554825|NCT03301467|182998279|SUPERIORITY||Mean Difference (Final Values)|10.67||||0.0221|TWO_SIDED|95.0|1.56|19.78|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||19.78|1.56|0.0221
91554826|NCT03301467|182998280|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.2638|TWO_SIDED|95.0|-3.08|11.08|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||11.08|-3.08|0.2638
91554827|NCT03301467|182998281|SUPERIORITY||Mean Difference (Final Values)|3.82||||0.2069|TWO_SIDED|95.0|-2.14|9.77|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||9.77|-2.14|0.2069
91554828|NCT03301467|182998282|SUPERIORITY||LSM UPCR Ratio|0.98||||0.9284|TWO_SIDED|95.0|0.67|1.45|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.45|0.67|0.9284
91554829|NCT03301467|182998283|SUPERIORITY||LSM UPCR Ratio|0.86||||0.3778|TWO_SIDED|95.0|0.6|1.21|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.21|0.60|0.3778
91554830|NCT03301467|182998284|SUPERIORITY||LSM MCP-1 Ratio|0.76||||0.081|TWO_SIDED|95.0|0.55|1.04|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.04|0.55|0.0810
91554831|NCT03301467|182998285|SUPERIORITY||LSM MCP-1 Ratio|0.87||||0.3233|TWO_SIDED|95.0|0.66|1.15|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.15|0.66|0.3233
91554832|NCT03301467|182998286|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6025|TWO_SIDED|95.0|-4.6|7.9|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||7.9|-4.6|0.6025
91554833|NCT03301467|182998286|SUPERIORITY||Mean Difference (Final Values)|-0.0422||||0.1797|TWO_SIDED|95.0|-0.1043|0.0198|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0198|-0.1043|0.1797
91554834|NCT03301467|182998287|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.4898|TWO_SIDED|95.0|-7.9|3.8|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||3.8|-7.9|0.4898
91554835|NCT03301467|182998287|SUPERIORITY||Mean Difference (Final Values)|-0.0199||||0.4826|TWO_SIDED|95.0|-0.0757|0.036|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0360|-0.0757|0.4826
91554836|NCT03301467|182998288|SUPERIORITY||Mean Difference (Final Values)|0.4019||||0.8161|TWO_SIDED|95.0|-3.0402|3.844|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.8440|-3.0402|0.8161
91554837|NCT03301467|182998288|SUPERIORITY||Mean Difference (Final Values)|0.0052||||0.9982|TWO_SIDED|95.0|-4.5994|4.6099|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||4.6099|-4.5994|0.9982
91554838|NCT03301467|182998289|SUPERIORITY||Mean Difference (Final Values)|-0.1518||||0.9242|TWO_SIDED|95.0|-3.3192|3.0156|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.0156|-3.3192|0.9242
91554839|NCT03301467|182998289|SUPERIORITY||Mean Difference (Final Values)|1.0283||||0.6534|TWO_SIDED|95.0|-3.4972|5.5537|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||5.5537|-3.4972|0.6534
91554840|NCT02798471|182998292|NON_INFERIORITY|The edoxaban-to-comparator hazard ratio will be computed with 95% confidence interval (CI) (two-sided) based on this model. Edoxaban will be considered non-inferior to comparator if the upper limit of the 95% CI is ≤1.5.|Hazard Ratio (HR)|1.01||||0.9694|TWO_SIDED|95.0|0.594|1.719|||Regression, Cox|||Statistical analysis for the composite primary efficacy endpoint||1.719|0.594|0.9694
91554841|NCT03367156|182998308|OTHER||Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.8|0.7|||Linear Model|||||0.7|-0.8|0.48
91554842|NCT03367156|182998309|OTHER||Mean Difference (Final Values)|0.2|||>|0.99|TWO_SIDED|95.0|-0.7|1.0|||Linear Model|||||1|-0.7|>0.99
91554843|NCT03367156|182998310|OTHER||Mean Difference (Final Values)|0.4||||0.97|TWO_SIDED|95.0|-0.7|1.6|||Linear Model|||||1.6|-0.7|0.97
91554844|NCT03367156|182998311|OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.8|1.0|||Linear Model|||||1.0|-0.8|0.78
91554845|NCT03367156|182998312|OTHER||Mean Difference (Final Values)|-0.5||||0.93|TWO_SIDED|95.0|-10.6|9.6|||Linear Model|||||9.6|-10.6|0.93
91554846|NCT03367156|182998313|OTHER||Mean Difference (Final Values)|0.6||||0.93|TWO_SIDED|95.0|-0.6|1.8|||Linear Model|||||1.8|-0.6|0.93
91554847|NCT03367156|182998314|OTHER||Mean Difference (Final Values)|0.1||||0.82|TWO_SIDED|95.0|-0.9|1.1|||Linear Model|||||1.1|-0.9|0.82
91554848|NCT03367156|182998315|OTHER||Mean Difference (Final Values)|-5.5||||0.38|TWO_SIDED|95.0|-17.9|6.9|||Linear Model|||||6.9|-17.9|0.38
91554849|NCT03762850|182998316|OTHER||Geometric Mean Ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.69|||Mixed Models Analysis|||||0.69|0.51|<0.0001
91554850|NCT03762850|182998317|OTHER||Slope difference|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0582|TWO_SIDED|95.0|-0.03|1.94|||Mixed Models Analysis|||||1.94|-0.03|0.0582
91554851|NCT03762850|182998318|OTHER||Slope difference|1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0369|TWO_SIDED|95.0|0.07|2.12|||Mixed Models Analysis|||||2.12|0.07|0.0369
91554852|NCT00092534|182998325|SUPERIORITY_OR_OTHER_LEGACY||Percent relative risk reduction|96.6||||||95.0|88.2|99.6|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||99.6|88.2|
91554853|NCT02347332|182998438|SUPERIORITY|||||||0.8329|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.8329
91554854|NCT02347332|182998439|SUPERIORITY|||||||0.3576|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.3576
91554855|NCT02347332|182998440|SUPERIORITY|||||||0.467|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.467
91554856|NCT02347332|182998441|SUPERIORITY|||||||0.243|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.243
91554857|NCT02347332|182998442|SUPERIORITY|||||||0.6289|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.6289
91554858|NCT00622700|182998486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.0087|TWO_SIDED|95.0|0.379|0.869||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.869|0.379|0.0087
91554859|NCT00622700|182998486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0271|TWO_SIDED|95.0|0.416|0.949||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.949|0.416|0.0271
91554860|NCT00622700|182998487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651||||0.0003|TWO_SIDED|95.0|0.515|0.822||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.822|0.515|0.0003
91767999|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.051|TWO_SIDED|95.0|-0.001|0.187|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.187|-0.001|0.051
91554861|NCT00622700|182998487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.002|TWO_SIDED|95.0|0.54|0.871||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.871|0.540|0.0020
91554862|NCT03611556|182998507|SUPERIORITY||Rate difference|-8.0||||0.3614|TWO_SIDED|95.0|-27.6|12.1||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -20.9 to 5.2|12.1|-27.6|0.3614
91554863|NCT03611556|182998507|SUPERIORITY||Rate difference|3.8||||0.6503|TWO_SIDED|95.0|-13.2|20.7||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -7.4 to 15.0|20.7|-13.2|0.6503
91554864|NCT03611556|182998514|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.79|1.983|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.983|0.790|
91554865|NCT03611556|182998514|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.498|1.131|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.131|0.498|
91554866|NCT03611556|182998516|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.726|1.837|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.837|0.726|
91768000|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.364|TWO_SIDED|95.0|-0.051|0.138|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.051|0.364
91768001|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.694|TWO_SIDED|95.0|-0.112|0.074|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.074|-0.112|0.694
91554867|NCT03611556|182998516|SUPERIORITY||Hazard Ratio (HR)|0.719|||||TWO_SIDED|95.0|0.468|1.105|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.105|0.468|
91554868|NCT03611556|182998520|SUPERIORITY||Rate difference|-1.7|||||TWO_SIDED|95.0|-25.2|21.9||||||||21.9|-25.2|
91554869|NCT03611556|182998520|SUPERIORITY||Rate difference|7.5|||||TWO_SIDED|95.0|-12.6|27.0||||||||27.0|-12.6|
91554870|NCT03611556|182998520|SUPERIORITY||Rate difference|-25.6|||||TWO_SIDED|95.0|-58.3|13.9||||||||13.9|-58.3|
91554871|NCT03611556|182998520|SUPERIORITY||Rate difference|-6.9|||||TWO_SIDED|95.0|-39.1|26.6||||||||26.6|-39.1|
91554872|NCT03611556|182998521|SUPERIORITY||Hazard Ratio (HR)|1.173|||||TWO_SIDED|95.0|0.676|1.985|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.985|0.676|
91554873|NCT03611556|182998521|SUPERIORITY||Hazard Ratio (HR)|0.605|||||TWO_SIDED|95.0|0.377|0.968|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.968|0.377|
91554874|NCT03611556|182998521|SUPERIORITY||Hazard Ratio (HR)|1.549|||||TWO_SIDED|95.0|0.622|3.917|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.917|0.622|
91554875|NCT03611556|182998521|SUPERIORITY||Hazard Ratio (HR)|1.472|||||TWO_SIDED|95.0|0.638|3.576|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.576|0.638|
91554876|NCT03611556|182998523|SUPERIORITY||Hazard Ratio (HR)|1.004|||||TWO_SIDED|95.0|0.584|1.693|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.693|0.584|
91554877|NCT03611556|182998523|SUPERIORITY||Hazard Ratio (HR)|0.598|||||TWO_SIDED|95.0|0.366|0.973|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.973|0.366|
91554878|NCT03611556|182998523|SUPERIORITY||Hazard Ratio (HR)|1.933|||||TWO_SIDED|95.0|0.716|5.437|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||5.437|0.716|
91554879|NCT03611556|182998523|SUPERIORITY||Hazard Ratio (HR)|1.374|||||TWO_SIDED|95.0|0.55|3.707|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.707|0.550|
91554880|NCT04027439|182998539|OTHER||Contrast Ratio|1.186|||<|0.0001|TWO_SIDED|95.0|1.138|1.235|||ANCOVA|||||1.235|1.138|<0.0001
91768002|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.297|TWO_SIDED|95.0|-0.143|0.044|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.044|-0.143|0.297
91554881|NCT04027439|182998539|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.088|1.181|||ANCOVA|||||1.181|1.088|<0.0001
91554882|NCT04027439|182998539|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.089|1.181|||ANCOVA|||||1.181|1.089|<0.0001
91554883|NCT04027439|182998539|OTHER||Contrast Ratio|1.084||||0.0001|TWO_SIDED|95.0|1.041|1.128|||ANCOVA|||||1.128|1.041|0.0001
91554884|NCT04027439|182998540|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.105|1.365|||ANCOVA|||||1.365|1.105|0.0004
91554885|NCT04027439|182998540|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.104|1.365|||ANCOVA|||||1.365|1.104|0.0004
91554886|NCT04027439|182998540|OTHER||Contrast Ratio|1.196||||0.0012|TWO_SIDED|95.0|1.08|1.326|||ANCOVA|||||1.326|1.080|0.0012
91554887|NCT04027439|182998540|OTHER||Contrast Ratio|1.121||||0.0348|TWO_SIDED|95.0|1.009|1.246|||ANCOVA|||||1.246|1.009|0.0348
91554888|NCT04027439|182998540|OTHER||Contrast Ratio|1.055||||0.3106|TWO_SIDED|95.0|0.949|1.172|||ANCOVA|||||1.172|0.949|0.3106
91554889|NCT04027439|182998541|OTHER||Contrast Ratio|1.154||||0.0208|TWO_SIDED|95.0|1.024|1.301|||ANCOVA|||||1.301|1.024|0.0208
91554890|NCT04027439|182998541|OTHER||Contrast Ratio|1.2||||0.0041|TWO_SIDED|95.0|1.064|1.353|||ANCOVA|||||1.353|1.064|0.0041
91554891|NCT04027439|182998541|OTHER||Contrast Ratio|1.167||||0.0108|TWO_SIDED|95.0|1.039|1.311|||ANCOVA|||||1.311|1.039|0.0108
91554892|NCT04027439|182998541|OTHER||Contrast Ratio|1.087||||0.1641|TWO_SIDED|95.0|0.965|1.225|||ANCOVA|||||1.225|0.965|0.1641
91554893|NCT04027439|182998542|OTHER||Contrast Ratio|1.229||||0.0005|TWO_SIDED|95.0|1.102|1.369|||ANCOVA|||||1.369|1.102|0.0005
91554894|NCT04027439|182998542|OTHER||Contrast Ratio|1.231||||0.0005|TWO_SIDED|95.0|1.104|1.372|||ANCOVA|||||1.372|1.104|0.0005
91768003|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|-0.016||||0.734|TWO_SIDED|95.0|-0.109|0.077|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.109|0.734
91768004|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.514|TWO_SIDED|95.0|-0.124|0.062|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.062|-0.124|0.514
91554895|NCT04027439|182998542|OTHER||Contrast Ratio|1.188||||0.0022|TWO_SIDED|95.0|1.07|1.32|||ANCOVA|||||1.320|1.070|0.0022
91554896|NCT04027439|182998542|OTHER||Contrast Ratio|1.106||||0.0658|TWO_SIDED|95.0|0.993|1.233|||ANCOVA|||||1.233|0.993|0.0658
91554897|NCT04027439|182998550|OTHER||Contrast Ratio|1.183|||<|0.0001|TWO_SIDED|95.0|1.134|1.234|||ANCOVA|||||1.234|1.134|<0.0001
91554898|NCT04027439|182998550|OTHER||Contrast Ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.092|1.19|||ANCOVA|||||1.190|1.092|<0.0001
91554899|NCT04027439|182998550|OTHER||Contrast Ratio|1.131|||<|0.0001|TWO_SIDED|95.0|1.084|1.18|||ANCOVA|||||1.180|1.084|<0.0001
91554900|NCT04027439|182998550|OTHER||Contrast Ratio|1.08||||0.0004|TWO_SIDED|95.0|1.036|1.126|||ANCOVA|||||1.126|1.036|0.0004
91554901|NCT04027439|182998551|OTHER||Contrast Ratio|1.123|||<|0.0001|TWO_SIDED|95.0|1.078|1.169|||ANCOVA|||||1.169|1.078|<0.0001
91554902|NCT04027439|182998551|OTHER||Contrast Ratio|1.078||||0.0004|TWO_SIDED|95.0|1.035|1.122|||ANCOVA|||||1.122|1.035|0.0004
91554903|NCT04027439|182998551|OTHER||Contrast Ratio|1.081||||0.0002|TWO_SIDED|95.0|1.039|1.125|||ANCOVA|||||1.125|1.039|0.0002
91554904|NCT04027439|182998551|OTHER||Contrast Ratio|1.041||||0.0437|TWO_SIDED|95.0|1.001|1.083|||ANCOVA|||||1.083|1.001|0.0437
91554905|NCT04027439|182998552|OTHER||Contrast Ratio|1.087||||0.0006|TWO_SIDED|95.0|1.038|1.139|||ANCOVA|||||1.139|1.038|0.0006
91554906|NCT04027439|182998552|OTHER||Contrast Ratio|1.083||||0.001|TWO_SIDED|95.0|1.034|1.135|||ANCOVA|||||1.135|1.034|0.0010
91554907|NCT04027439|182998552|OTHER||Contrast Ratio|1.096||||0.0002|TWO_SIDED|95.0|1.047|1.149|||ANCOVA|||||1.149|1.047|0.0002
91554908|NCT04027439|182998552|OTHER||Contrast Ratio|1.039||||0.0971|TWO_SIDED|95.0|0.993|1.088|||ANCOVA|||||1.088|0.993|0.0971
91554909|NCT04027439|182998553|OTHER||Contrast Ratio|1.145|||<|0.0001|TWO_SIDED|95.0|1.106|1.185|||ANCOVA|||||1.185|1.106|<0.0001
91554910|NCT04027439|182998553|OTHER||Contrast Ratio|1.148|||<|0.0001|TWO_SIDED|95.0|1.109|1.189|||ANCOVA|||||1.189|1.109|<0.0001
91554911|NCT04027439|182998553|OTHER||Contrast Ratio|1.099|||<|0.0001|TWO_SIDED|95.0|1.062|1.137|||ANCOVA|||||1.137|1.062|<0.0001
91554912|NCT04027439|182998553|OTHER||Contrast Ratio|1.088|||<|0.0001|TWO_SIDED|95.0|1.052|1.126|||ANCOVA|||||1.126|1.052|<0.0001
91554913|NCT04027439|182998554|OTHER||Contrast Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.113|1.189|||ANCOVA|||||1.189|1.113|<0.0001
91554914|NCT04027439|182998554|OTHER||Contrast Ratio|1.146|||<|0.0001|TWO_SIDED|95.0|1.109|1.185|||ANCOVA|||||1.185|1.109|<0.0001
91554915|NCT04027439|182998554|OTHER||Contrast Ratio|1.107|||<|0.0001|TWO_SIDED|95.0|1.071|1.144|||ANCOVA|||||1.144|1.071|<0.0001
91554916|NCT04027439|182998554|OTHER||Contrast Ratio|1.094|||<|0.0001|TWO_SIDED|95.0|1.059|1.13|||ANCOVA|||||1.130|1.059|<0.0001
91554917|NCT04027439|182998555|OTHER||Contrast Ratio|1.103|||<|0.0001|TWO_SIDED|95.0|1.066|1.141|||ANCOVA|||||1.141|1.066|<0.0001
91554918|NCT04027439|182998555|OTHER||Contrast Ratio|1.078|||<|0.0001|TWO_SIDED|95.0|1.042|1.116|||ANCOVA|||||1.116|1.042|<0.0001
91554919|NCT04027439|182998555|OTHER||Contrast Ratio|1.067||||0.0002|TWO_SIDED|95.0|1.032|1.104|||ANCOVA|||||1.104|1.032|0.0002
91554920|NCT04027439|182998555|OTHER||Contrast Ratio|1.048||||0.0066|TWO_SIDED|95.0|1.013|1.084|||ANCOVA|||||1.084|1.013|0.0066
91554921|NCT04035447|182998604|SUPERIORITY|||||||0.519|||||||t-test, 2 sided|||Satisfaction with Therapy (ST)||||0.519
91554922|NCT04035447|182998604|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Satisfaction with Therapist (SWT)||||0.150
91554923|NCT04035447|182998604|SUPERIORITY|||||||0.309|||||||t-test, 2 sided|||Global Improvement (Item 13)||||0.309
91554924|NCT04035447|182998606|SUPERIORITY|||||||0.696|||||||t-test, 2 sided|||||||0.696
91554925|NCT04035447|182998607|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
91554926|NCT04035447|182998608|SUPERIORITY|||||||0.274|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.274
91554927|NCT04035447|182998609|SUPERIORITY|||||||0.6|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.600
91554928|NCT04035447|182998610|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_DEVIATION|8.4||0.1848|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.1848
91554929|NCT04035447|182998611|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.4||0.6153|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.07||||||0.6153
91554930|NCT04035447|182998612|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_DEVIATION|16.1||0.0563|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.28||||||0.0563
91554931|NCT04035447|182998613|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.8||0.0265|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.31||||||0.0265
91554932|NCT04035447|182998613|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_DEVIATION|2.6||0.2084|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.2084
91554933|NCT04035447|182998614|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|9.4||0.3512|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of -0.13||||||0.3512
91554934|NCT05966155|182998636|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.677|TWO_SIDED|95.0|-1.54|1.0|||t-test, 2 sided|||||1.00|-1.54|0.677
91554935|NCT05966155|182998637|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.1264|TWO_SIDED|95.0|-1.4|0.2|||t-test, 2 sided|||||0.2|-1.4|0.1264
91554936|NCT05966155|182998638|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3692|TWO_SIDED|95.0|-0.4|1.1|||t-test, 2 sided||The by-group means and the estimated mean difference are independently rounded to the nearest tenth. As a result, the mean difference it not exactly equivalent to the difference in the two reported means.|||1.1|-0.4|0.3692
91554937|NCT05966155|182998639|SUPERIORITY|||||||0.8492|||||||Chi-squared|||||||0.8492
91768005|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.957|TWO_SIDED|95.0|-0.09|0.095|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.090|0.957
91768006|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.479|TWO_SIDED|95.0|-0.06|0.127|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.127|-0.060|0.479
91768007|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.687|TWO_SIDED|95.0|-0.079|0.12|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.120|-0.079|0.687
91554938|NCT05966155|182998640|SUPERIORITY|||||||0.0246|||||||Chi-squared|||||||0.0246
91554939|NCT05966155|182998641|SUPERIORITY|||||||0.0111|||||||Chi-squared|||||||0.0111
91554940|NCT05966155|182998642|SUPERIORITY|||||||0.0776|||||||Chi-squared|||||||0.0776
91554941|NCT05966155|182998643|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
91554942|NCT00174252|182998739|SUPERIORITY_OR_OTHER||Percentage|86.0|||||TWO_SIDED|95.0|74.2|93.7|||||95% CI was estimated using the F-distribution.|"Applies to no."||93.7|74.2|
91554943|NCT00174252|182998739|SUPERIORITY_OR_OTHER||Percentage|14.0||||||95.0|6.3|25.8|||||95% confidence interval (CI) was estimated using the F-distribution.|"Applies to yes."||25.8|6.3|
91554944|NCT00174252|182998753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.002||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.002
91554945|NCT00174252|182998754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.023||95.0||||Bilateral test multiple comparison threshold for statistical significance = 0.05|ANCOVA|Adjusted for height SD at baseline.||||||0.023
91554946|NCT00174252|182998755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.708||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.708
91554947|NCT00174252|182998756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.325||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.325
91554948|NCT05509816|182998766|SUPERIORITY||Ratio of Geometric least squares mean|0.929|||||TWO_SIDED|90.0|0.849|1.02|||Mixed Models Analysis||The least square means (LSMs) and differences in LSMs were back transformed to produce the geometric least square means (GLSMs) and ratio between GLSMs. These were reported along with the 90% confidence interval (CI) for the ratio.|A mixed effects model was used to estimate drug-drug interaction using the Model: Log(PK) = Treatment + Participant + Random Error, where Participant is fitted as a random effect.||1.02|0.849|
91554949|NCT05509816|182998767|SUPERIORITY||Ratio of Geometric least squares mean|1.07|||||TWO_SIDED|90.0|0.989|1.16|||Mixed Models Analysis||The LSMs and differences in LSMs were back transformed to produce the GLSMs and ratio between GLSMs. These were reported along with the 90% CI for the ratio.|A mixed effects model was used to estimate drug-drug interaction using the Model: Log(PK) = Treatment + Participant + Random Error, where Participant is fitted as a random effect.||1.16|0.989|
91554950|NCT05509816|182998768|SUPERIORITY||Ratio of Geometric least squares mean|0.821|||||TWO_SIDED|90.0|0.777|0.868|||Mixed Models Analysis|||A mixed effects model was used to estimate drug-drug interaction using the Model: Log(PK) = Treatment + Participant + Random Error, where Participant is fitted as a random effect.||0.868|0.777|
91554951|NCT05509816|182998769|SUPERIORITY||Ratio of Geometric least squares mean|0.964|||||TWO_SIDED|90.0|0.828|1.12|||Mixed Models Analysis|||A mixed effects model was used to estimate drug-drug interaction using the Model: Log(PK) = Treatment + Participant + Random Error, where Participant is fitted as a random effect.||1.12|0.828|
91554952|NCT00979121|182998798|SUPERIORITY_OR_OTHER||difference in % of pts alive at 60 days|4.0||||0.21|TWO_SIDED|95.0|-2.3|10.2||The monitoring boundaries were designed to have a low probability of stopping for futility before 750 patients. The maximum sample size was 1000 patients. Efficacy stopping was based on mortality; futility stopping was based on mortality and VFDs.|Proc lifetest|Proc lifetest was used to calculate mortality mean and variance due to one subject lost to follow up who was censored.||Hospital mortality to day 60 was estimated using the Kaplan Meier estimate, with patients discharged home before day 60 considered alive at day 60. The analysis was stratified by co-enrolled treatment assignments for 81 patients also enrolled in a randomized clinical trial of two different nutritional strategies. A maximum of 1000 patients were to be enrolled, providing a 92% probability of rejecting the null hypothesis for the effect on mortality if a true difference in mortality was 9%.||10.2|-2.3|0.21
91554953|NCT00979121|182998799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.96||95.0|-1.6|1.5|||ANCOVA|||Ventilator, ICU free, and organ failure free days were analyzed by analysis of variance, utilizing treatment assignment where applicable.||1.5|-1.6|0.96
91768008|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.195|TWO_SIDED|95.0|-0.034|0.165|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.165|-0.034|0.195
91554954|NCT02130557|182998839|SUPERIORITY||Odds Ratio (OR)|1.547||||0.01|TWO_SIDED|95.0|1.072|2.233||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.025.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|A total sample size of 500 Ph+ participants is required for the study to provide \>= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O'Brien-Fleming analog beta spending function).||2.233|1.072|0.0100
91554955|NCT02130557|182998840|SUPERIORITY||Odds Ratio (OR)|1.418||||0.0303|TWO_SIDED|95.0|0.986|2.037||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.037|0.986|0.0303
91554956|NCT02130557|182998841|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.49|2.44|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||2.44|0.49|
91554957|NCT02130557|182998842|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0037|TWO_SIDED|95.0|1.16|2.61||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.610|1.160|0.0037
91554958|NCT02130557|182998843|SUPERIORITY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.14|1.13|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||1.13|0.14|
91554959|NCT02130557|182998844|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0749|TWO_SIDED|95.0|0.35|1.17||1-sided p-value based on Gray's test for comparing cumulative incidence function between treatment arms stratified by sokal risk group (low, intermediate, high) and region (1-3). Statistical significance threshold: 1-sided 0.0125.|Gray's test||The hazard ratio (95% CIs) are based on the proportional subdistribution hazards model stratified by Sokal risk group and region.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.17|0.35|0.0749
91768009|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.03|TWO_SIDED|95.0|0.011|0.212|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.212|0.011|0.030
91768010|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.112|TWO_SIDED|95.0|-0.019|0.179|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.179|-0.019|0.112
91554960|NCT02130557|182998845|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2827|TWO_SIDED|95.0|0.37|1.73||1-sided p-value based on log-rank test for comparing survival curves between treatment arms stratified by sokal risk group and region. OS was not tested as EFS was not significant.|Log Rank||The hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.73|0.37|0.2827
91554961|NCT01532999|182998858|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks. Data structure involved repeated measures over time nested within participant, who in turn, was nested within a therapy group. Models included a random intercept, a random slope, and fixed effects for treatment condition, time, and the stratification variable (site). Rejection of the null hypothesis of no treatment effect if this interaction was statistically significant (two-tailed α = .05).||||0.5
91554962|NCT01532999|182998859|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.57
91554963|NCT01532999|182998861|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
91554964|NCT01532999|182998862|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.8
91768011|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.147|TWO_SIDED|95.0|-0.026|0.174|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.174|-0.026|0.147
91554965|NCT01532999|182998863|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
91554966|NCT01532999|182998864|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.35
91554967|NCT01532999|182998865|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.3
91554968|NCT01532999|182998866|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.7
91554969|NCT03333109|182998896|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.34||0.002|TWO_SIDED|95.0|-1.77|-0.42|||Mixed Models Analysis|||||-0.42|-1.77|0.002
91554970|NCT03333109|182998896|SUPERIORITY||Median Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.45|-0.93|||Mixed Models Analysis|||||-0.93|-2.45|<0.001
91554971|NCT03333109|182998897|SUPERIORITY||Odds Ratio (OR)|1.52||||0.007|TWO_SIDED|95.0|1.12|2.07|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||2.07|1.12|0.007
91554972|NCT03333109|182998897|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.55|3.15|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||3.15|1.55|<0.001
91768012|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.37|TWO_SIDED|95.0|-0.054|0.144|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.144|-0.054|0.370
91768013|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.074|TWO_SIDED|95.0|-0.009|0.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|-0.009|0.074
91554973|NCT03333109|182998898|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.07|-0.64|||Mixed Models Analysis|||||-0.64|-2.07|<0.001
91554974|NCT03333109|182998898|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.71|-1.09|||Mixed Models Analysis|||||-1.09|-2.71|<0.001
91554975|NCT03333109|182998899|SUPERIORITY||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.62||0.004|TWO_SIDED|95.0|-2.99|-0.56|||Mixed Models Analysis|||||-0.56|-2.99|0.004
91554976|NCT03333109|182998899|SUPERIORITY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-4.07|-1.36|||Mixed Models Analysis|||||-1.36|-4.07|<0.001
91554977|NCT00918203|182998900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2133|TWO_SIDED|95.0|0.86|1.93|||Log Rank|||||1.93|0.86|0.2133
91554978|NCT00918203|182998903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8731|TWO_SIDED|95.0|0.68|1.57|||Log Rank|||||1.57|0.68|0.8731
91554979|NCT00918203|182998904|SUPERIORITY_OR_OTHER|||||||0.4721|||||||Fisher Exact|||||||0.4721
91554980|NCT01447706|182998915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.76|||Log Rank|||||0.76|0.18|0.007
91554981|NCT01447706|182998915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.023|TWO_SIDED|95.0|1.08|2.98|||Log Rank|||||2.98|1.08|0.023
91554982|NCT04066075|182998916|SUPERIORITY|||||||0.73||||||The p-value represents the difference between telerehabilitation and usual care.|Multilevel linear regression model|||Multilevel modeling in linear regression analyses accounted for within-patient correlations for the 3 assessments at baseline, 1-month and 4-months. Rasch analysis using the method of successive dichotomizations was applied to estimate person measures. Power calculation: a matched pairs t-test revealed 18 subjects per group would detect a within-subject mean improvement of 0.14-logits with 0.17-logits standard deviation for the differences, 0.80 power and 0.05 type 1 error probability.||||0.73
91554983|NCT00650078|182998943|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.001|TWO_SIDED|95.0|1.39|3.64||The p-value was based on logistic regression with treatment, geographic region, gender, and median age class as factors.|Regression, Logistic|||||3.64|1.39|0.0010
91554984|NCT00650078|182998944|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.6||||0.0015|TWO_SIDED|95.0|-31.7|-6.1||Wilcoxon Rank Sum Test p-value|Hodges-Lehman method|The difference between the treatment groups was assessed using the median and the 95% CI of the median computed using the Hodges Lehmann method.||||-6.1|-31.7|0.0015
91554985|NCT02678689|182998945|SUPERIORITY|The two-sample T-test with unequal variance was conducted at a significance level of 0.05|||||<|0.0001|||||||t-test, unequal variance|||||||< 0.0001
91554986|NCT02678689|182998946|SUPERIORITY||Hazard Ratio (HR)|0.091|||<|0.0001|TWO_SIDED|95.0|0.021|0.393|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.393|0.021|<.0001
91554987|NCT02678689|182998947|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0032|TWO_SIDED|95.0|0.0|0.0|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.000|0.000|0.0032
91554988|NCT02678689|182998948|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
91554989|NCT02678689|182998949|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
91554990|NCT02678689|182998950|SUPERIORITY||Hazard Ratio (HR)|0.209||||0.0081|TWO_SIDED|95.0|0.059|0.735|||Cox Model Wald Test|The p value is a test that the hazard ratio equal to 1.|"Hazard ratio is based on Cox proportional hazards model with a factor of study group.~Hazard Ratio (HR) 190-203 vs DEM-CHILD."|||0.735|0.059|0.0081
91554991|NCT03244800|182998999|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91554992|NCT03244800|182999000|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91554993|NCT03244800|182999001|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91554994|NCT03244800|182999002|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91554995|NCT03244800|182999003|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
91554996|NCT03244800|182999004|SUPERIORITY||Odds Ratio (OR)|10.76||||0.04|TWO_SIDED|90.0|1.61|72.03|||Regression, Logistic|||||72.03|1.61|0.040
91554997|NCT03983434|182999067|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.62|||||||Kruskal-Wallis|||||||.62
91554998|NCT03983434|182999068|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
91554999|NCT03983434|182999069|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
91555000|NCT03983434|182999070|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.079|||||||Kruskal-Wallis|||||||0.079
91555001|NCT03983434|182999071|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.47|||||||Kruskal-Wallis|||||||0.47
91768014|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.233|TWO_SIDED|95.0|-0.039|0.158|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.158|-0.039|0.233
91555002|NCT03983434|182999073|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.03|||||||Kruskal-Wallis|||||||0.03
91555003|NCT03983434|182999074|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.14|||||||Kruskal-Wallis|||||||0.14
91555004|NCT03983434|182999075|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.074|||||||Kruskal-Wallis|||||||0.074
91555005|NCT03983434|182999076|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
91555006|NCT03983434|182999077|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
91555007|NCT03983434|182999078|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.98|||||||Kruskal-Wallis|||||||0.98
91555008|NCT01536093|182999079|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
91555009|NCT01536093|182999080|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
91555010|NCT01536093|182999081|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91555011|NCT01536093|182999082|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
91555012|NCT01536093|182999083|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
91555013|NCT01536093|182999084|SUPERIORITY_OR_OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
91555014|NCT02195232|182999104|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
91555015|NCT00811941|182999125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.62||0.16|TWO_SIDED|95.0|-2.1|0.35|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. Null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.35|-2.10|0.160
91555016|NCT00811941|182999126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|STANDARD_ERROR_OF_MEAN|2.9||0.232|TWO_SIDED|95.0|-9.17|2.23|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||2.23|-9.17|0.232
91555017|NCT00811941|182999127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.689|TWO_SIDED|95.0|0.59|1.41|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.41|0.59|0.689
91555018|NCT00811941|182999128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.046|TWO_SIDED|95.0|-0.37|0.0|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.00|-0.37|0.046
91555019|NCT00811941|182999129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|95.0|-0.36|0.08|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||0.08|-0.36|0.217
91768015|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.369|TWO_SIDED|95.0|-0.054|0.145|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.145|-0.054|0.369
91768016|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.773|TWO_SIDED|95.0|-0.084|0.112|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.112|-0.084|0.773
91555020|NCT00811941|182999130|SUPERIORITY_OR_OTHER||Ratio to placebo|0.93||||0.273|TWO_SIDED|95.0|0.83|1.05|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 319 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.05|0.83|0.273
91555021|NCT00811941|182999131|SUPERIORITY_OR_OTHER||Ratio to placebo|0.99||||0.916|TWO_SIDED|95.0|0.9|1.1|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 318 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.10|0.90|0.916
91555022|NCT00811941|182999132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.65||0.017|TWO_SIDED|95.0|-2.85|-0.29|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.29|-2.85|0.017
91555023|NCT00811941|182999133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|3.07||0.036|TWO_SIDED|95.0|-12.53|-0.42|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.42|-12.53|0.036
91555024|NCT00811941|182999134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.976|TWO_SIDED|95.0|0.67|1.52|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.52|0.67|0.976
91768017|NCT03084796|183425149|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.536|TWO_SIDED|95.0|-0.13|0.068|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.068|-0.130|0.536
91768018|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.05||||0.848|TWO_SIDED|95.0|0.62|1.77|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||1.77|0.62|0.848
91555025|NCT00811941|182999135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.056|TWO_SIDED|95.0|-0.44|0.01|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||0.01|-0.44|0.056
91555026|NCT00811941|182999136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.029||95.0|-0.5|-0.03|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||-0.03|-0.50|0.029
91555027|NCT00811941|182999137|SUPERIORITY_OR_OTHER||Ratio to placebo|0.78||||0.001|TWO_SIDED|95.0|0.67|0.9|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 98 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.90|0.67|0.001
91555028|NCT00811941|182999138|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.037|TWO_SIDED|95.0|0.79|0.99|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.99|0.79|0.037
91768019|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.35||||0.264|TWO_SIDED|95.0|0.8|2.28|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.28|0.80|0.264
91768020|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.29||||0.343|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.76|0.343
91555029|NCT03802994|182999143|EQUIVALENCE|Differences between groups were compared using the paired t test|||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||Differences between groups were compared using the paired t test||||<0.05
91555030|NCT03802994|182999143|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91555031|NCT03802994|182999143|SUPERIORITY||||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||||||<0.05
91555032|NCT03802994|182999144|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91555033|NCT03802994|182999144|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91555034|NCT03802994|182999145|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91768021|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.98|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.98|1.02|0.042
91555035|NCT03802994|182999146|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91555036|NCT02029235|182999191|OTHER|||||||0.24|||||||t-test, 2 sided|||"Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm."||||0.24
91555037|NCT02029235|182999192|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: No difference between groups||||0.06
91555038|NCT04057820|182999223|SUPERIORITY||Incidence rate ratio (IRR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.65|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.65|0.46|<0.0001
91555039|NCT04057820|182999224|SUPERIORITY||Risk Ratio (RR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.3|0.47|||Mixed-effect Poisson w/ robust err var|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.47|0.30|<0.0001
91555040|NCT04057820|182999225|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-0.4|4.9||||||||4.9|-0.4|
91555041|NCT04057820|182999226|SUPERIORITY||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|8.1|37.9||||||||37.9|8.1|
91555042|NCT04057820|182999227|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.37|1.76||||||||1.76|0.37|
91555043|NCT04057820|182999228|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||||1.0|-0.3|
91555044|NCT04057820|182999229|SUPERIORITY||Risk Ratio (RR)|1.94|||||TWO_SIDED|95.0|0.94|3.99||||||||3.99|0.94|
91768022|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.2||||0.503|TWO_SIDED|95.0|0.71|2.02|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.02|0.71|0.503
91555045|NCT04057820|182999230|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|1.13|2.48||||||||2.48|1.13|
91555046|NCT04057820|182999231|SUPERIORITY||Incidence ratio ratio (IRR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.64|0.49|
91555047|NCT04057820|182999233|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.71|1.47||||||||1.47|0.71|
91555048|NCT03211247|182999270|OTHER||Proportion difference|33.4|||<|0.001|TWO_SIDED|95.0|22.36|44.49|||Wald test||The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.|Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Farrington-Manning 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Farrignton-Manning 95% CI of the difference in response rates ≥15%.||44.49|22.36|<0.001
91555049|NCT02415127|182999276|SUPERIORITY|||||||0.5442||||||From a repeated-measures ANCOVA with fixed effects of treatment, visit, and treatment\*visit with baseline score and investigative site as covariates using an unstructured covariance matrix, testing ACTIMMUNE® vs placebo.|ANCOVA|||The primary and secondary efficacy endpoints were tested in a hierarchical manner. Each endpoint was tested in sequential order and the current endpoint must have shown statistical significance (p \< 0.05) prior to performing testing the next endpoint. The primary endpoint, FARS-mNeuro, was to be tested first, followed by the key secondary endpoint, ADL, followed by the other secondary endpoints, T25FW, FARS-mNeuro responder rate, and FARStot.||||0.5442
91555050|NCT05120856|182999287|SUPERIORITY||Slope|-1.106369|STANDARD_ERROR_OF_MEAN|0.4985347||0.026|TWO_SIDED|95.0|-2.083479|-0.129259||This is the p value for the overall group x time interaction.|Mixed Models Analysis|The model compared groups' change across all time points Time was coded as a continuous variable (i.e., 0, 4, 8, and 16).|This is the effect estimate for the group x time interaction.|||-0.129259|-2.083479|.026
91555051|NCT05120856|182999287|SUPERIORITY||Mean Difference (Final Values)|5.025|STANDARD_ERROR_OF_MEAN|8.737||0.565|TWO_SIDED|95.0|-12.098|22.149|||t-test, 2 sided|||planned between-group post-hoc comparison at 4-week follow-up||22.149|-12.098|.565
91555052|NCT05120856|182999287|SUPERIORITY||Mean Difference (Final Values)|-3.349|STANDARD_ERROR_OF_MEAN|8.891||0.706|TWO_SIDED|95.0|-20.774|14.077|||t-test, 2 sided|||Planned post-hoc comparison between groups at 8-week follow-up||14.077|-20.774|.706
91555053|NCT05120856|182999287|SUPERIORITY||Mean Difference (Final Values)|-6.921|STANDARD_ERROR_OF_MEAN|9.394||0.461|TWO_SIDED|95.0|-25.332|11.491|||t-test, 2 sided|||Planned post-hoc comparison between groups at 16-week follow-up||11.491|-25.332|.461
91555054|NCT05120856|182999287|SUPERIORITY||Slope|-1.0838|STANDARD_ERROR_OF_MEAN|0.4798||0.0252|TWO_SIDED|95.0|-2.0229626|-0.1419329||This is the p value for the group x time interaction|Mixed Models Analysis|||In an additional sensitivity analysis, past-week alcohol use data was excluded if a participant reported having been in residential/inpatient treatment where they could not access alcohol for the whole of the past week at the time of follow-up. This resulted in data for one participant in the ApBM group being excluded at week 8, and 1 control being excluded at week 16.||-0.1419329|-2.0229626|.0252
91555055|NCT05120856|182999288|SUPERIORITY||Slope|-0.016|STANDARD_ERROR_OF_MEAN|0.033||0.633|TWO_SIDED|95.0|-0.08|0.05||This is the p value for the time x group interaction.|Mixed Models Analysis|||This is the test for the overall CEQ-F scores||0.05|-0.08|.633
91768023|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.28||||0.354|TWO_SIDED|95.0|0.76|2.16|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.16|0.76|0.354
91555056|NCT05120856|182999288|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.041||0.411|TWO_SIDED|95.0|-0.11|0.05||This is for the time x group interaction for the intensity subscale|Mixed Models Analysis|||This is for the test of the CEQ-F Intensity subscale score||0.05|-0.11|.411
91555057|NCT05120856|182999288|SUPERIORITY||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.808|TWO_SIDED|95.0|-0.08|0.06||p value for the time x group interaction for Imagery subscale|Mixed Models Analysis|||Analysis of CEQ-F Imagery subscale score||0.06|-0.08|.808
91555058|NCT05120856|182999288|SUPERIORITY||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.041||0.886|TWO_SIDED|95.0|-0.09|0.08||This is the p value for the time x group interaction for the Intrusiveness subscale score|Mixed Models Analysis|||This is for the analysis of the CEQ-F Intrusiveness subscale score||0.08|-0.09|.886
91768024|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.22||||0.447|TWO_SIDED|95.0|0.73|2.07|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.07|0.73|0.447
91555059|NCT05120856|182999289|SUPERIORITY||Slope|0.083|STANDARD_ERROR_OF_MEAN|0.066||0.207|TWO_SIDED|95.0|-0.046|0.212||This is the p value for the time x group interaction|Mixed Models Analysis|||||0.212|-0.046|.207
91555060|NCT05120856|182999290|SUPERIORITY||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.166||0.876|TWO_SIDED|95.0|-0.352|0.3||This is the p value for the group x time interaction.|Mixed Models Analysis|||||0.300|-0.352|.876
91768025|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.66||||0.064|TWO_SIDED|95.0|0.97|2.83|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.83|0.97|0.064
91768026|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|0.96||||0.867|TWO_SIDED|95.0|0.57|1.62|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.62|0.57|0.867
91768027|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.29||||0.347|TWO_SIDED|95.0|0.76|2.22|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.22|0.76|0.347
91768028|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.35||||0.269|TWO_SIDED|95.0|0.79|2.32|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.32|0.79|0.269
91555061|NCT05120856|182999291|SUPERIORITY||Slope|-0.069|STANDARD_ERROR_OF_MEAN|0.037||0.064|TWO_SIDED|95.0|-0.142|0.004||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.004|-0.142|.064
91555062|NCT05120856|182999292|SUPERIORITY||Slope|-0.059|STANDARD_ERROR_OF_MEAN|0.143||0.679|TWO_SIDED|95.0|-0.338|0.22||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.220|-0.338|.679
91555063|NCT05120856|182999294|SUPERIORITY||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.086||0.403|TWO_SIDED|95.0|-0.097|0.24||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.240|-0.097|.403
91555064|NCT05120856|182999295|SUPERIORITY||Slope|-0.052|STANDARD_ERROR_OF_MEAN|0.037||0.161|TWO_SIDED|95.0|-0.126|0.021||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of psychological well-being ratings.||0.021|-0.126|.161
91555065|NCT05120856|182999295|SUPERIORITY||Slope|-0.029|STANDARD_ERROR_OF_MEAN|0.036||0.425|TWO_SIDED|95.0|-0.099|0.042||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of physical well-being ratings||0.042|-0.099|.425
91555066|NCT05120856|182999295|SUPERIORITY||Slope|-0.039|STANDARD_ERROR_OF_MEAN|0.034||0.247|TWO_SIDED|95.0|-0.106|0.027||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of quality of life ratings||0.027|-0.106|.247
91555067|NCT05120856|182999296|SUPERIORITY||Slope|3.645|STANDARD_ERROR_OF_MEAN|10.369||0.725|TWO_SIDED|95.0|-16.68|23.97||This is the p value for the group x time interaction|Mixed Models Analysis|||||23.97|-16.68|.725
91555068|NCT05630833|182999297|OTHER||Lower 10th percentile (%)|48.2|||||||||||||Lower 10th percentile of therapeutic successes was calculated from the predictive distribution.|As defined in Statistical Analysis Plan, consistency with the global studies is demonstrated if the success criterion for gepotidacin is set to require a therapeutic response rate greater than lower 10th percentile value of the predictive distribution.||||
91555069|NCT01958021|182999336|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.556||||3.29e-06|TWO_SIDED|95.0|0.429|0.72|||Log Rank|||||0.720|0.429|0.00000329
91555070|NCT01958021|182999337|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.004|TWO_SIDED|95.0|0.628|0.932|||Log Rank|||||0.932|0.628|0.004
91555071|NCT01958021|182999338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.000155|||||||Cochran-Mantel-Haenszel|||||||0.000155
91555072|NCT01958021|182999339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
91555073|NCT00490139|182999344|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.048|TWO_SIDED|95.0|0.71|1.0|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.00|0.71|0.048
91768029|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.92||||0.018|TWO_SIDED|95.0|1.12|3.3|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||3.30|1.12|0.018
91555074|NCT00490139|182999344|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.81|1.13|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.13|0.81|0.610
91555075|NCT00490139|182999345|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.887|||||TWO_SIDED|95.0|0.77|1.02|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.02|0.77|
91555076|NCT00490139|182999345|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.914|||||TWO_SIDED|95.0|0.8|1.05|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.05|0.80|
91555077|NCT00490139|182999346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.078|TWO_SIDED|95.0|0.62|1.03|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.62|0.078
91555078|NCT00490139|182999346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.433|TWO_SIDED|95.0|0.71|1.16|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.16|0.71|0.433
91555079|NCT00490139|182999347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.853|||||TWO_SIDED|95.0|0.7|1.03|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.70|
91555080|NCT00490139|182999347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.863|||||TWO_SIDED|95.0|0.71|1.04|||||The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.04|0.71|
91768030|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.5|4.49|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.49|1.50|<0.001
91768031|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.75|5.44|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.44|1.75|<0.001
91768032|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.94|6.02|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.02|1.94|<0.001
91555081|NCT00490139|182999348|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.811|||||TWO_SIDED|95.0|0.68|0.96||||||||0.96|0.68|
91555082|NCT00490139|182999348|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1||||||||1.10|0.79|
91555083|NCT00490139|182999349|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.852|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
91555084|NCT00490139|182999349|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.968|||||TWO_SIDED|95.0|0.81|1.16||||||||1.16|0.81|
91555085|NCT00490139|182999350|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.986|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
91555086|NCT00490139|182999350|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
91555087|NCT04640974|182999353|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91555088|NCT04640974|182999354|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91555089|NCT04640974|182999355|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
91555090|NCT02036970|182999359|SUPERIORITY||Mean Difference (Net)|-1.74||||0.8133|TWO_SIDED|95.0|-16.22|12.74||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PAH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated and compared with placebo through 16 weeks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment and visit as fixed factors. A compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 used in the model with the change from baseline at Wk16 as primary endpoint.||12.74|-16.22|0.8133
91768033|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|2.45||||0.001|TWO_SIDED|95.0|1.41|4.26|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.26|1.41|0.001
91555091|NCT02036970|182999359|SUPERIORITY||Mean Difference (Net)|-3.17||||0.759|TWO_SIDED|95.0|-23.54|17.2||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary hypertension (PH)|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated \& compared with placebo through 16 wks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment \& visit as fixed factors. Compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 were used in the model with the change from baseline at Wk 16 as the primary endpoint||17.20|-23.54|0.759
91555092|NCT02298842|182999388|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Binomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
91555093|NCT02298842|182999389|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Bionomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
91555094|NCT02298842|182999390|NON_INFERIORITY|If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|15.099|STANDARD_DEVIATION|5.6367|||ONE_SIDED|97.5||16.738|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selectin's mean difference, Test - 1.25 \* Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.||16.738||
91768034|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.35||||0.284|TWO_SIDED|95.0|0.78|2.35|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.35|0.78|0.284
91768035|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.61||||0.103|TWO_SIDED|95.0|0.91|2.84|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.84|0.91|0.103
91768036|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.78||||0.045|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.14|1.01|0.045
91768037|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.19||||0.557|TWO_SIDED|95.0|0.67|2.12|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.12|0.67|0.557
91768038|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.32||||0.345|TWO_SIDED|95.0|0.74|2.34|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.34|0.74|0.345
91768039|NCT03084796|183425150|SUPERIORITY||Odds Ratio (OR)|1.11||||0.732|TWO_SIDED|95.0|0.61|2.0|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.00|0.61|0.732
91768040|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.666|TWO_SIDED|95.0|-0.52|0.81|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the BDI, BDI by visit interaction as covariates."||0.81|-0.52|0.666
91768041|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.224|TWO_SIDED|95.0|-0.25|1.07|||Mixed Models Analysis|||"week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.07|-0.25|0.224
91768042|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.239|TWO_SIDED|95.0|-0.27|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.27|0.239
91768043|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.019|TWO_SIDED|95.0|0.13|1.46|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.46|0.13|0.019
91768044|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.124|TWO_SIDED|95.0|-0.14|1.19|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.14|0.124
91555095|NCT02298842|182999391|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Median Difference (Final Values)|-0.418|STANDARD_DEVIATION|4.5531|||ONE_SIDED|97.5|-1.544||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-1.544|
91555096|NCT02298842|182999392|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-0.667|STANDARD_DEVIATION|6.7882|||ONE_SIDED|97.5|-2.499||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-2.499|
91555097|NCT02298842|182999393|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|46.1|STANDARD_DEVIATION|23.056|||ONE_SIDED|97.5|40.02||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||40.020|
91555098|NCT02298842|182999394|NON_INFERIORITY|Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|12.314|STANDARD_DEVIATION|6.0422|||ONE_SIDED|97.5||13.981|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selection's mean difference, Test - 1.25 \* Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.||13.981||
91555099|NCT02298842|182999395|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-3.042|STANDARD_DEVIATION|5.422|||ONE_SIDED|97.5|-4.407||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.407|
91555100|NCT02298842|182999396|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-2.389|STANDARD_DEVIATION|9.0544|||ONE_SIDED|97.5|-4.915||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.915|
91768045|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.432|TWO_SIDED|95.0|-0.39|0.92|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.92|-0.39|0.432
91555101|NCT02298842|182999397|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|26.05|||ONE_SIDED|97.5|36.821||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||36.821|
91555102|NCT00065182|182999434|SUPERIORITY||Hazard Ratio (HR)|1.007||||0.946|TWO_SIDED|95.0|0.813|1.248|||Log Rank||Unadjusted hazard ratio.|||1.248|0.813|0.9460
91555103|NCT00065182|182999434|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.788|1.21|||||Adjusted hazard ratio.|||1.210|0.788|
91555104|NCT03801148|182999463|EQUIVALENCE|Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|0.98|||||TWO_SIDED|90.0|0.9171|1.0473||||||||1.0473|0.9171|
91555105|NCT03801148|182999463|EQUIVALENCE|ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|1.0737|||||TWO_SIDED|90.0|1.0025|1.1501||||||||1.1501|1.0025|
91555106|NCT03801148|182999464|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.0455|||||TWO_SIDED|90.0|1.007|1.0855||||||||1.0855|1.0070|
91555107|NCT03801148|182999464|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.061|||||TWO_SIDED|90.0|1.0192|1.1046||||||||1.1046|1.0192|
91555108|NCT03801148|182999465|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|Geometric LSM ratio|1.0553|||||TWO_SIDED|90.0|1.0186|1.0933||||||||1.0933|1.0186|
91555109|NCT03801148|182999465|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|GMR|1.0468|||||TWO_SIDED|90.0|1.0027|1.0929||||||||1.0929|1.0027|
91555110|NCT03801148|182999466|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0555|||||TWO_SIDED|90.0|1.0188|1.0935||||||||1.0935|1.0188|
91555111|NCT03801148|182999466|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0472|||||TWO_SIDED|90.0|1.0029|1.0934||||||||1.0934|1.0029|
91768046|NCT03084796|183425151|SUPERIORITY||Mean Difference (Net)|0.25||||0.454|TWO_SIDED|95.0|-0.41|0.91|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.91|-0.41|0.454
91768047|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.053|TWO_SIDED|95.0|-0.01|1.31|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.31|-0.01|0.053
91768048|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.973|TWO_SIDED|95.0|-0.67|0.65|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.65|-0.67|0.973
91768049|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.247|TWO_SIDED|95.0|-0.27|1.04|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.04|-0.27|0.247
91768050|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
91555112|NCT06212752|182999468|NON_INFERIORITY|Non-inferiority margin is 0.8.|Geometric Mean Ratio (GMR)|1.1|||||TWO_SIDED|95.0|0.95|1.27|||||GMR and associated 96% confidence interval (Cl) were calculated using the Welch's t test. GMR was calculated as geometric mean (GM) of Pembrolizumab Formulated with Berahyaluronidase Alfa to GM of Pembrolizumab.|||1.27|0.95|
91555113|NCT06212752|182999469|NON_INFERIORITY|Non-inferiority margin is 0.8.|GMR|1.46|||||TWO_SIDED|95.0|1.14|1.88|||||GMR and associated 95% CI were calculated using the Welch's t test. GMR was calculated as geometric mean (GM) of Pembrolizumab Formulated with Berahyaluronidase Alfa to GM of Pembrolizumab.|||1.88|1.14|
91555114|NCT04162210|182999480|OTHER||Stratified Hazard Ratio (HR)|1.03||||0.558|TWO_SIDED|95.0|0.72|1.47|||Log Rank|One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.|HR was estimated using the Cox Proportional Hazards. HR stratified log-rank test were adjusted for previous treatment with anti-CD38, international staging system (ISS) staging and number of prior lines of therapy.|||1.47|0.72|0.558
91555115|NCT02568215|182999526|OTHER||Prevention Efficacy (PE)|8.8||||0.7|TWO_SIDED|95.0|-45.1|42.6||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||42.6|-45.1|0.70
91555116|NCT02568215|182999526|OTHER||Prevention Efficacy (PE)|-9.3|||||TWO_SIDED|95.0|-85.3|35.5||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||35.5|-85.3|
91555117|NCT02568215|182999526|OTHER||Prevention Efficacy (PE)|27.0|||||TWO_SIDED|95.0|-30.7|59.3||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||59.3|-30.7|
91555118|NCT02568215|182999528|OTHER||Prevention Efficacy (PE)|78.6|||||TWO_SIDED|95.0|17.3|94.4||||||PE against IC80 of least sensitive variant less than 1||94.4|17.3|
91555119|NCT02568215|182999528|OTHER||Prevention Efficacy (PE)|7.4|||||TWO_SIDED|95.0|-187.5|70.2||||||PE against IC80 of least sensitive variant 1-3||70.2|-187.5|
91555120|NCT02568215|182999528|OTHER||Prevention Efficacy (PE)|-1.9|||||TWO_SIDED|95.0|-83.1|43.3||||||PE against IC80 of least sensitive variant \> 3||43.3|-83.1|
91555121|NCT02941549|182999532|SUPERIORITY||LS Mean Difference|-6.9||||0.5946|TWO_SIDED|95.0|-34.5|20.7|||ANCOVA|||||20.7|-34.5|0.5946
91768051|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.071|TWO_SIDED|95.0|-0.05|1.28|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.28|-0.05|0.071
91555122|NCT02941549|182999532|SUPERIORITY||LS Mean Difference|-10.1||||0.7309|TWO_SIDED|95.0|-36.9|16.8|||ANCOVA|||||16.8|-36.9|0.7309
91555123|NCT02941549|182999533|SUPERIORITY||LS Mean Difference|-1.308||||0.0763|TWO_SIDED|95.0|-2.11|-0.51|||ANCOVA|||||-0.51|-2.11|0.0763
91555124|NCT02941549|182999533|SUPERIORITY||LS Mean Difference|-0.727||||0.0058|TWO_SIDED|95.0|-1.554|0.1|||ANCOVA|||||0.100|-1.554|0.0058
91555125|NCT05580003|182999579|OTHER||Ratio of Adjusted Geometric Means|101.29|||||TWO_SIDED|90.0|95.71|107.18|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||107.18|95.71|
91555126|NCT05580003|182999579|OTHER||Ratio of Adjusted Geometric Means|102.74|||||TWO_SIDED|90.0|97.28|108.5|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||108.50|97.28|
91768052|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.004|TWO_SIDED|95.0|0.32|1.64|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.64|0.32|0.004
91768053|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.003|TWO_SIDED|95.0|0.35|1.68|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.68|0.35|0.003
91555127|NCT05580003|182999579|OTHER||Ratio of Adjusted Geometric Means|97.83|||||TWO_SIDED|90.0|91.32|104.8|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||104.80|91.32|
91555128|NCT05580003|182999579|OTHER||Ratio of Adjusted Geometric Means|102.41|||||TWO_SIDED|90.0|95.6|109.7|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||109.70|95.60|
91555129|NCT05580003|182999580|OTHER||Ratio of Adjusted Geometric Means|67.18|||||TWO_SIDED|90.0|58.13|77.65|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||77.65|58.13|
91555130|NCT05580003|182999580|OTHER||Ratio of Adjusted Geometric Means|74.12|||||TWO_SIDED|90.0|64.14|85.67|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||85.67|64.14|
91555131|NCT05580003|182999616|OTHER||Ratio of Adjusted Geometric Means|72.87|||||TWO_SIDED|90.0|60.98|87.09|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||87.09|60.98|
91555132|NCT05580003|182999616|OTHER||Ratio of Adjusted Geometric Means|76.45|||||TWO_SIDED|90.0|68.35|85.52|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||85.52|68.35|
91555133|NCT05580003|182999616|OTHER||Ratio of Adjusted Geometric Means|73.52|||||TWO_SIDED|90.0|65.7|82.27|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||82.27|65.70|
91555134|NCT05580003|182999616|OTHER||Ratio of Adjusted Geometric Means|75.16|||||TWO_SIDED|90.0|66.36|85.13|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||85.13|66.36|
91555135|NCT05580003|182999617|OTHER||Ratio of Adjusted Geometric Means|76.72|||||TWO_SIDED|90.0|60.21|97.75|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||97.75|60.21|
91555136|NCT05580003|182999617|OTHER||Ratio of Adjusted Geometric Means|70.92|||||TWO_SIDED|90.0|53.7|93.67|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||93.67|53.70|
91555137|NCT02392234|182999670|SUPERIORITY||Least Squares (LS) Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.7|5.8|||Linear Mixed Effects Model|||||5.8|3.7|< 0.0001
91555138|NCT02392234|182999670|SUPERIORITY||LS Mean Difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.7|7.8|||Linear Mixed Effects Model|||||7.8|5.7|< 0.0001
91555139|NCT02392234|182999671|SUPERIORITY||LS Mean Difference|9.7|||<|0.0001|TWO_SIDED|95.0|7.2|12.2|||Linear Mixed Effects Model|||||12.2|7.2|<0.0001
91555140|NCT02392234|182999671|SUPERIORITY||LS Mean Difference|11.1|||<|0.0001|TWO_SIDED|95.0|8.7|13.6|||Linear Mixed Effects Model|||||13.6|8.7|<0.0001
91555141|NCT02392234|182999673|SUPERIORITY||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|6.3|9.9|||Linear Mixed Effects Model|||||9.9|6.3|<0.0001
91555142|NCT02392234|182999673|SUPERIORITY||LS Mean Difference|11.4|||<|0.0001|TWO_SIDED|95.0|9.6|13.2|||Linear Mixed Effects Model|||||13.2|9.6|<0.0001
91555143|NCT02392234|182999674|SUPERIORITY||LS Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.7|-2.3|||Linear Mixed Effects Model|||||-2.3|-6.7|<0.0001
91555144|NCT02392234|182999674|SUPERIORITY||LS Mean Difference|-9.5|||<|0.0001|TWO_SIDED|95.0|-11.7|-7.3|||Linear Mixed Effects Model|||||-7.3|-11.7|<0.0001
91555145|NCT00859781|182999709|SUPERIORITY||proportion difference|0.26||||0.08|TWO_SIDED|95.0|0.008|0.52|||Fisher Exact||Direction = 177Lu-J591 + Ketoconazole proportion free of radiographically evident metastases minus 111ln-J591 + Ketoconazole proportion free of radiographically evident metastases.|||0.52|0.008|0.08
91555146|NCT02307682|182999749|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.0003|TWO_SIDED|95.0|-2.5|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.5|0.0003
91555147|NCT02307682|182999749|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-2.1|1.8||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.8|-2.1|<0.0001
91555148|NCT02307682|182999750|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-2.4|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.4|0.0001
91555149|NCT02307682|182999750|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-1.9|1.9||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.9|-1.9|<0.0001
91555150|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-1.4|0.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||0.9|-1.4|
91768054|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.86|2.18|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.86|<0.001
91768055|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.002|TWO_SIDED|95.0|0.41|1.75|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.75|0.41|0.002
91768056|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.271|TWO_SIDED|95.0|-0.29|1.03|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.03|-0.29|0.271
91555151|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.4|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.1|-1.4|
91555152|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.4|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||1.2|-1.4|
91555153|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.7|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||1.2|-1.7|
91555154|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.8|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||1.2|-1.8|
91555155|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||1.6|-1.5|
91555156|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.8|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||1.5|-1.8|
91555157|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||2.1|-1.1|
91555158|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.2|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||1.0|-2.2|
91555159|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.2|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||1.2|-2.2|
91555160|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.1|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||1.3|-2.1|
91555161|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.9|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||1.6|-1.9|
91555162|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||1.7|-1.9|
91555163|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||2.2|-1.4|
91555164|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.4|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||1.3|-2.4|
91555165|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-1.2|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||2.5|-1.2|
91555166|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.9|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.8|-2.9|
91555167|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.1|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||1.6|-2.1|
91555168|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.2|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||1.6|-2.2|
91555169|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.9|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||2.1|-1.9|
91555170|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||1.9|-2.1|
91555171|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||2.2|-1.8|
91555172|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.3|-2.5|
91555173|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.8|-2.1|
91555174|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.2|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||1.8|-2.2|
91555175|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.9|-2.2|
91555176|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.5|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||1.5|-2.5|
91555177|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.7|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.4|-2.7|
91555178|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||1.9|-2.1|
91555179|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.9|-2.2|
91555180|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.3|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||1.7|-2.3|
91555181|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.9|-2.2|
91555182|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.1|2.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||2.0|-2.1|
91555183|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.9|-2.2|
91555184|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-2.0|2.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||2.3|-2.0|
91555185|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-2.4|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.8|-2.4|
91555186|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||2.4|-1.8|
91555187|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||2.1|-2.1|
91555188|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||2.7|-1.5|
91555189|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.4|2.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||2.8|-1.4|
91555190|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||2.7|-1.5|
91555191|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||2.4|-1.8|
91555192|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||2.5|-1.8|
91555193|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||2.4|-1.9|
91555194|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||2.5|-1.9|
91555195|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||2.5|-1.8|
91555196|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.5|-1.9|
91555197|NCT02307682|182999755|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.6|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||2.7|-1.6|
91768057|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
91768058|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.007|TWO_SIDED|95.0|0.25|1.56|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.56|0.25|0.007
91768059|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.923|TWO_SIDED|95.0|-0.63|0.69|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.69|-0.63|0.923
91768060|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.108|TWO_SIDED|95.0|-0.12|1.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.12|0.108
91768061|NCT03084796|183425151|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.134|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.16|-0.16|0.134
91768062|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|7.88||||0.022|TWO_SIDED|95.0|1.13|14.63|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||14.63|1.13|0.022
91555198|NCT02307682|182999756|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||1.1|-1.9|
91555199|NCT02307682|182999756|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||1.6|-1.5|
91768063|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|6.78||||0.048|TWO_SIDED|95.0|0.07|13.48|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.48|0.07|0.048
91768064|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|6.65||||0.053|TWO_SIDED|95.0|-0.09|13.4|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.40|-0.09|0.053
91768065|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|9.29||||0.007|TWO_SIDED|95.0|2.55|16.04|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.04|2.55|0.007
91768066|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|4.61||||0.191|TWO_SIDED|95.0|-2.31|11.53|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.53|-2.31|0.191
91768067|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.747|TWO_SIDED|95.0|-7.8|5.6|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.60|-7.80|0.747
91768068|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.72|TWO_SIDED|95.0|-7.96|5.5|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.50|-7.96|0.720
91555200|NCT02307682|182999756|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-1.8|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||1.6|-1.8|
91555201|NCT02307682|182999756|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.7|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||1.8|-1.7|
91555202|NCT02307682|182999757|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.0|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 48||1.2|-2.0|
91555203|NCT02307682|182999757|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.6|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||1.8|-1.6|
91555204|NCT02307682|182999757|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 96||1.7|-1.9|
91555205|NCT02307682|182999757|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.7|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 96||1.9|-1.7|
91555206|NCT02307682|182999758|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||2.5|-1.7|
91555207|NCT02307682|182999758|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||2.5|-1.7|
91555208|NCT02307682|182999759|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.2|-4.2|
91555209|NCT02307682|182999759|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.8|-2.8|
91555210|NCT02307682|182999759|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.4|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.9|-4.4|
91555211|NCT02307682|182999759|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-1.2|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||10.0|-1.2|
91555212|NCT02307682|182999759|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-5.9|
91555213|NCT02307682|182999759|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-0.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||11.0|-0.5|
91555214|NCT02307682|182999759|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.0|-3.7|
91555215|NCT02307682|182999759|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.3|-3.8|
91555216|NCT02307682|182999759|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.1|-5.9|
91555217|NCT02307682|182999759|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.4|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.4|
91555218|NCT02307682|182999759|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-4.2|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||7.3|-4.2|
91555219|NCT02307682|182999759|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.8|13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||13.4|0.8|
91555220|NCT02307682|182999759|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.3|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.5|-4.3|
91555221|NCT02307682|182999759|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.4|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.4|-3.4|
91555222|NCT02307682|182999759|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.0|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.2|-5.0|
91555223|NCT02307682|182999759|OTHER||Difference in proportions|7.9|||||TWO_SIDED|95.0|1.5|14.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||14.4|1.5|
91555224|NCT02307682|182999759|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.0|-5.4|
91555225|NCT02307682|182999759|OTHER||Difference in proportions|8.1|||||TWO_SIDED|95.0|2.1|14.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||14.5|2.1|
91555226|NCT02307682|182999759|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-4.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||8.1|-4.4|
91555227|NCT02307682|182999759|OTHER||Difference in proportions|8.3|||||TWO_SIDED|95.0|2.0|15.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||15.1|2.0|
91555228|NCT02307682|182999759|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.1|-5.2|
91555229|NCT02307682|182999759|OTHER||Difference in proportions|7.6|||||TWO_SIDED|95.0|0.7|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.8|0.7|
91555230|NCT02307682|182999759|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-6.8|
91555231|NCT02307682|182999759|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|2.2|15.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||15.0|2.2|
91555232|NCT02307682|182999759|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.9|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||9.2|-3.9|
91555233|NCT02307682|182999759|OTHER||Difference in proportions|4.8|||||TWO_SIDED|95.0|-1.5|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||11.4|-1.5|
91555234|NCT02307682|182999759|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-5.9|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.1|-5.9|
91555235|NCT02307682|182999759|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.1|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||9.7|-3.1|
91555236|NCT02307682|182999759|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-6.5|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.5|-6.5|
91768069|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.68|TWO_SIDED|95.0|-5.31|8.14|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.14|-5.31|0.680
91768070|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.971|TWO_SIDED|95.0|-6.82|6.57|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.57|-6.82|0.971
91555237|NCT02307682|182999759|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-1.3|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.4|-1.3|
91555238|NCT02307682|182999759|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-2.9|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.2|-2.9|
91555239|NCT02307682|182999759|OTHER||Difference in proportions|5.8|||||TWO_SIDED|95.0|-0.4|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||12.3|-0.4|
91555240|NCT02307682|182999759|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.2|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.0|-4.2|
91555241|NCT02307682|182999759|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-0.2|11.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||11.9|-0.2|
91555242|NCT02307682|182999759|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.9|-3.0|
91555243|NCT02307682|182999759|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.1|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||11.4|-1.1|
91555244|NCT02307682|182999759|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-1.5|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||12.8|-1.5|
91555245|NCT02307682|182999759|OTHER||Difference in proportions|5.0|||||TWO_SIDED|95.0|-1.0|11.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||11.6|-1.0|
91555246|NCT02307682|182999759|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.6|-5.1|
91555247|NCT02307682|182999759|OTHER||Difference in proportions|8.8|||||TWO_SIDED|95.0|2.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||15.4|2.7|
91555248|NCT02307682|182999759|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.7|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.4|-3.7|
91555249|NCT02307682|182999759|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.2|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.3|-2.2|
91555250|NCT02307682|182999759|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-3.0|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.9|-3.0|
91555251|NCT02307682|182999759|OTHER||Difference in proportions|8.0|||||TWO_SIDED|95.0|1.9|14.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||14.6|1.9|
91555252|NCT02307682|182999759|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.1|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.1|
91768071|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|2.52||||0.46|TWO_SIDED|95.0|-4.17|9.21|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.21|-4.17|0.460
91768072|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.441|TWO_SIDED|95.0|-4.09|9.37|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.37|-4.09|0.441
91555253|NCT02307682|182999759|OTHER||Difference in proportions|5.9|||||TWO_SIDED|95.0|0.0|12.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.5|-0.0|
91555254|NCT02307682|182999759|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.2|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.3|-1.2|
91555255|NCT02307682|182999759|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|1.4|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||13.8|1.4|
91768073|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.07|TWO_SIDED|95.0|-0.55|14.08|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.08|-0.55|0.070
91768074|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|8.44||||0.023|TWO_SIDED|95.0|1.16|15.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||15.72|1.16|0.023
91768075|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|6.96||||0.064|TWO_SIDED|95.0|-0.4|14.31|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.31|-0.40|0.064
91768076|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|11.08||||0.003|TWO_SIDED|95.0|3.79|18.38|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||18.38|3.79|0.003
91555256|NCT02307682|182999760|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.3|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.9|-4.3|
91768077|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.274|TWO_SIDED|95.0|-3.32|11.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.72|-3.32|0.274
91768078|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.649|TWO_SIDED|95.0|-5.57|8.93|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.93|-5.57|0.649
91768079|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.958|TWO_SIDED|95.0|-7.12|7.51|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||7.51|-7.12|0.958
91768080|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|4.32||||0.242|TWO_SIDED|95.0|-2.93|11.58|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.58|-2.93|0.242
91768081|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.69|TWO_SIDED|95.0|-8.77|5.81|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.81|-8.77|0.690
91555257|NCT02307682|182999760|OTHER||Difference in proportions|6.3|||||TWO_SIDED|95.0|0.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||12.2|0.6|
91555258|NCT02307682|182999760|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.6|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.7|-6.6|
91555259|NCT02307682|182999760|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||8.0|-4.7|
91555260|NCT02307682|182999760|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.1|-6.2|
91555261|NCT02307682|182999760|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||12.7|-0.8|
91555262|NCT02307682|182999760|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.0|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||7.7|-6.0|
91555263|NCT02307682|182999760|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.5|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||12.2|-1.5|
91555264|NCT02307682|182999760|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.5|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.0|-6.5|
91555265|NCT02307682|182999760|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.8|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.2|-1.8|
91555266|NCT02307682|182999760|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.0|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||9.5|-4.0|
91555267|NCT02307682|182999760|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.5|11.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||11.3|-3.5|
91555268|NCT02307682|182999760|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.9|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.2|-5.9|
91768082|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.473|TWO_SIDED|95.0|-4.58|9.87|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.87|-4.58|0.473
91768083|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|4.13||||0.267|TWO_SIDED|95.0|-3.17|11.43|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.43|-3.17|0.267
91768084|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|7.32||||0.032|TWO_SIDED|95.0|0.65|13.99|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.99|0.65|0.032
91555269|NCT02307682|182999760|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.4|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||11.2|-3.4|
91555270|NCT02307682|182999760|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-8.2|
91555271|NCT02307682|182999760|OTHER||Difference in proportions|3.6|||||TWO_SIDED|95.0|-3.2|10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.5|-3.2|
91555272|NCT02307682|182999760|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.3|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-7.3|
91555273|NCT02307682|182999760|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.2|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.6|-5.2|
91555274|NCT02307682|182999760|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.6|-7.8|
91555275|NCT02307682|182999760|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.8|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||10.0|-4.8|
91555276|NCT02307682|182999760|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.4|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.2|-4.4|
91555277|NCT02307682|182999760|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-7.1|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.2|-7.1|
91555278|NCT02307682|182999760|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.9|
91555279|NCT02307682|182999760|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||9.2|-4.5|
91555280|NCT02307682|182999760|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.8|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-6.8|
91555281|NCT02307682|182999760|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.4|-5.8|
91555282|NCT02307682|182999760|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.1|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.2|-6.1|
91555283|NCT02307682|182999760|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.6|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.6|-8.6|
91555284|NCT02307682|182999760|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.0|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||7.1|-7.0|
91555285|NCT02307682|182999760|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.0|-3.5|
91555286|NCT02307682|182999760|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-3.0|10.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.8|-3.0|
91555287|NCT02307682|182999760|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.4|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||13.0|-1.4|
91555288|NCT02307682|182999760|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-4.1|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.5|-4.1|
91555289|NCT02307682|182999760|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.7|-4.8|
91555290|NCT02307682|182999760|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.6|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||12.3|-1.6|
91555291|NCT02307682|182999760|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.4|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.6|-5.4|
91555292|NCT02307682|182999760|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.8|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.4|-4.8|
91555293|NCT02307682|182999760|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.0|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.2|-5.0|
91768085|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|7.61||||0.025|TWO_SIDED|95.0|0.97|14.24|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.24|0.97|0.025
91555294|NCT02307682|182999760|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||7.4|-6.9|
91555295|NCT02307682|182999760|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.5|-5.1|
91555296|NCT02307682|182999760|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.9|10.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.1|-3.9|
91555297|NCT02307682|182999760|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-5.0|9.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.1|-5.0|
91555298|NCT02307682|182999760|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.5|11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||11.8|-2.5|
91555299|NCT02307682|182999760|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.4|10.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.6|-3.4|
91555300|NCT02307682|182999760|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.2|-1.6|
91555301|NCT02307682|182999760|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.0|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.2|-3.0|
91555302|NCT02307682|182999760|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.9|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.7|-1.9|
91555303|NCT02307682|182999760|OTHER||Difference in proportions|5.7|||||TWO_SIDED|95.0|-1.0|12.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.6|-1.0|
91555304|NCT02307682|182999761|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.7|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.0|-7.7|
91555305|NCT02307682|182999761|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.3|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||8.7|-5.3|
91555306|NCT02307682|182999761|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.4|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-7.4|
91555307|NCT02307682|182999761|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-8.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.3|-8.9|
91555308|NCT02307682|182999761|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-8.1|
91555309|NCT02307682|182999761|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||8.8|-4.8|
91555310|NCT02307682|182999761|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.7|-9.8|
91555311|NCT02307682|182999761|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.3|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.6|-5.3|
91555312|NCT02307682|182999761|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.6|-9.7|
91555313|NCT02307682|182999761|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-11.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-11.4|
91555314|NCT02307682|182999761|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.6|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.1|-7.6|
91768086|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.046|TWO_SIDED|95.0|0.12|13.49|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.49|0.12|0.046
91768087|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|10.19||||0.003|TWO_SIDED|95.0|3.52|16.85|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.85|3.52|0.003
91555315|NCT02307682|182999761|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.4|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||10.0|-4.4|
91555316|NCT02307682|182999761|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.9|-7.2|
91555317|NCT02307682|182999761|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-6.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.8|-6.3|
91555318|NCT02307682|182999761|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.7|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||9.2|-4.7|
91555319|NCT02307682|182999761|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.3|-3.9|
91555320|NCT02307682|182999761|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-12.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-12.6|
91555321|NCT02307682|182999761|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.7|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.9|-12.7|
91555322|NCT02307682|182999761|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.1|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.1|
91555323|NCT02307682|182999761|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.2|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||7.9|-6.2|
91555324|NCT02307682|182999761|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.9|-9.6|
91555325|NCT02307682|182999761|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-9.1|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.4|-9.1|
91555326|NCT02307682|182999761|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.1|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.1|-11.1|
91555327|NCT02307682|182999761|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.5|-10.4|
91555328|NCT02307682|182999761|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
91768088|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.207|TWO_SIDED|95.0|-2.45|11.25|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.25|-2.45|0.207
91768089|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.932|TWO_SIDED|95.0|-6.33|6.91|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.91|-6.33|0.932
91555329|NCT02307682|182999761|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-9.7|
91555330|NCT02307682|182999761|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.5|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.9|-5.5|
91555331|NCT02307682|182999761|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.5|-7.2|
91555332|NCT02307682|182999761|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||8.4|-5.8|
91555333|NCT02307682|182999761|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.9|-7.2|
91555334|NCT02307682|182999761|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.5|-7.9|
91555335|NCT02307682|182999761|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.6|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-6.6|
91555336|NCT02307682|182999761|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-9.4|
91768090|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.879|TWO_SIDED|95.0|-7.17|6.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.14|-7.17|0.879
91768091|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.396|TWO_SIDED|95.0|-3.77|9.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.50|-3.77|0.396
91555337|NCT02307682|182999761|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-10.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-10.0|
91555338|NCT02307682|182999761|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-6.2|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.2|-6.2|
91555339|NCT02307682|182999761|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.5|9.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.3|-5.5|
91555340|NCT02307682|182999761|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-5.1|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.6|-5.1|
91768092|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.812|TWO_SIDED|95.0|-7.44|5.83|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.83|-7.44|0.812
91768093|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.444|TWO_SIDED|95.0|-4.03|9.19|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.19|-4.03|0.444
91768094|NCT03084796|183425152|SUPERIORITY||Mean Difference (Final Values)|3.38||||0.319|TWO_SIDED|95.0|-3.27|10.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||10.04|-3.27|0.319
91768095|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.67|-0.18|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.18|-0.67|<0.001
91768096|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.023|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.53|0.023
91768097|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.067|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.02|-0.47|0.067
91555341|NCT02307682|182999761|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.9|-5.0|
91555342|NCT02307682|182999761|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.3|-3.9|
91555343|NCT02307682|182999761|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-6.1|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.1|-6.1|
91555344|NCT02307682|182999761|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.1|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.9|-5.1|
91555345|NCT02307682|182999761|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-5.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.4|-5.9|
91555346|NCT02307682|182999761|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.8|-8.5|
91555347|NCT02307682|182999761|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.7|-9.7|
91555348|NCT02307682|182999761|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.9|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-7.9|
91555349|NCT02307682|182999761|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.1|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-9.1|
91555350|NCT02307682|182999761|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.9|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||11.2|-2.9|
91555351|NCT02307682|182999761|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-6.6|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.0|-6.6|
91555352|NCT02307682|182999762|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-1.4|
91555353|NCT02307682|182999762|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-0.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.0|-0.5|
91555354|NCT02307682|182999762|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.6|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.5|-2.6|
91555355|NCT02307682|182999762|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-1.7|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-1.7|
91555356|NCT02307682|182999762|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-3.3|
91555357|NCT02307682|182999762|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.2|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.7|-3.2|
91555358|NCT02307682|182999762|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.0|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.4|-3.0|
91555359|NCT02307682|182999762|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.1|-2.4|
91555360|NCT02307682|182999762|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-2.2|
91555361|NCT02307682|182999762|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-0.3|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||5.3|-0.3|
91555362|NCT02307682|182999762|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.2|-2.6|
91555363|NCT02307682|182999762|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-1.8|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||4.6|-1.8|
91555364|NCT02307682|182999762|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-2.9|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.3|-2.9|
91555365|NCT02307682|182999762|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.6|-2.3|
91555366|NCT02307682|182999762|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-2.0|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.1|-2.0|
91555367|NCT02307682|182999762|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-1.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.7|-1.0|
91555368|NCT02307682|182999762|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-1.5|
91555369|NCT02307682|182999762|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|0.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.5|0.0|
91555370|NCT02307682|182999762|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.1|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-2.1|
91555371|NCT02307682|182999762|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-0.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.3|-0.7|
91768098|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.66|-0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.66|<0.001
91555372|NCT02307682|182999762|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-2.2|
91768099|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.084|TWO_SIDED|95.0|-0.47|0.03|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.47|0.084
91555373|NCT02307682|182999762|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-1.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.2|-1.4|
91555374|NCT02307682|182999762|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.9|-3.2|
91555375|NCT02307682|182999762|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.7|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.3|-2.7|
91555376|NCT02307682|182999762|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.3|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-3.3|
91555377|NCT02307682|182999762|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-2.5|
91555378|NCT02307682|182999762|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.6|-2.4|
91555379|NCT02307682|182999762|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.5|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.3|-1.5|
91768100|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.243|TWO_SIDED|95.0|-0.1|0.39|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.39|-0.10|0.243
91555380|NCT02307682|182999762|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.6|-3.5|
91555381|NCT02307682|182999762|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.9|-2.9|
91555382|NCT02307682|182999762|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-2.4|
91555383|NCT02307682|182999762|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.7|-1.3|
91555384|NCT02307682|182999762|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-3.1|
91555385|NCT02307682|182999762|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-2.9|
91555386|NCT02307682|182999762|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-2.6|
91555387|NCT02307682|182999762|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.7|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.3|-2.7|
91555388|NCT02307682|182999762|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.1|
91555389|NCT02307682|182999762|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.1|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.0|-2.1|
91555390|NCT02307682|182999762|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-4.8|
91555391|NCT02307682|182999762|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.9|-4.6|
91555392|NCT02307682|182999762|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-2.6|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.4|-2.6|
91555393|NCT02307682|182999762|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-3.7|
91555394|NCT02307682|182999762|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.4|-3.7|
91555395|NCT02307682|182999762|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-4.1|
91555396|NCT02307682|182999762|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-2.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-2.2|
91555397|NCT02307682|182999762|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-3.0|
91555398|NCT02307682|182999762|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.9|-2.9|
91555399|NCT02307682|182999762|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.6|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-3.6|
91555400|NCT02307682|182999763|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.7|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-3.7|
91555401|NCT02307682|182999763|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.4|-2.6|
91555402|NCT02307682|182999763|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.3|-3.3|
91768101|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.112|TWO_SIDED|95.0|-0.05|0.44|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.44|-0.05|0.112
91555403|NCT02307682|182999763|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.0|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-3.0|
91555404|NCT02307682|182999763|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-4.6|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-4.6|
91555405|NCT02307682|182999763|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.6|-3.5|
91555406|NCT02307682|182999763|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.9|-4.2|
91555407|NCT02307682|182999763|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.0|-5.0|
91555408|NCT02307682|182999763|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-4.1|
91555409|NCT02307682|182999763|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.7|-2.3|
91555410|NCT02307682|182999763|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.1|-3.9|
91555411|NCT02307682|182999763|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.2|-1.8|
91768102|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.929|TWO_SIDED|95.0|-0.23|0.26|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.23|0.929
91555412|NCT02307682|182999763|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.7|-3.5|
91555413|NCT02307682|182999763|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.6|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.4|-3.6|
91555414|NCT02307682|182999763|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.6|-3.2|
91555415|NCT02307682|182999763|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-3.2|
91555416|NCT02307682|182999763|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.3|-2.6|
91768103|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.30|-0.19|0.668
91768104|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.281|TWO_SIDED|95.0|-0.38|0.11|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.11|-0.38|0.281
91768105|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.134|TWO_SIDED|95.0|-0.43|0.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.43|0.134
91768106|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.003|TWO_SIDED|95.0|-0.7|-0.14|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.14|-0.70|0.003
91555417|NCT02307682|182999763|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.9|-2.1|
91555418|NCT02307682|182999763|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-4.3|
91768107|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.02|TWO_SIDED|95.0|-0.61|-0.05|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.05|-0.61|0.020
91768108|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.017|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.62|0.017
91555419|NCT02307682|182999763|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.8|-3.6|
91555420|NCT02307682|182999763|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.8|-3.7|
91555421|NCT02307682|182999763|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.7|-3.7|
91768109|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.24|-0.80|<0.001
91555422|NCT02307682|182999763|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-2.2|
91555423|NCT02307682|182999763|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.3|-2.9|
91555424|NCT02307682|182999763|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-3.5|
91555425|NCT02307682|182999763|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-1.6|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.3|-1.6|
91768110|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.115|TWO_SIDED|95.0|-0.52|0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.52|0.115
91768111|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.532|TWO_SIDED|95.0|-0.19|0.36|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.19|0.532
91768112|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.603|TWO_SIDED|95.0|-0.21|0.35|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.35|-0.21|0.603
91555426|NCT02307682|182999763|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.3|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-2.3|
91555427|NCT02307682|182999763|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-2.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.7|-2.2|
91555428|NCT02307682|182999763|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.8|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-4.8|
91555429|NCT02307682|182999763|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.8|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.9|-3.8|
91555430|NCT02307682|182999763|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-3.1|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-3.1|
91555431|NCT02307682|182999763|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.4|-2.8|
91768113|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.46|TWO_SIDED|95.0|-0.38|0.17|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.17|-0.38|0.460
91555432|NCT02307682|182999763|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-3.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-3.4|
91555433|NCT02307682|182999763|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.6|-2.8|
91555434|NCT02307682|182999763|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-6.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.5|-6.6|
91555435|NCT02307682|182999763|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.8|-6.1|
91555436|NCT02307682|182999763|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.6|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.1|-5.6|
91768114|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.921|TWO_SIDED|95.0|-0.29|0.26|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.29|0.921
91768115|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.172|TWO_SIDED|95.0|-0.47|0.08|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.47|0.172
91555437|NCT02307682|182999763|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.9|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.9|-2.9|
91555438|NCT02307682|182999763|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-5.8|
91555439|NCT02307682|182999763|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.5|-3.2|
91555440|NCT02307682|182999763|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.2|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.0|-4.2|
91555441|NCT02307682|182999763|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.7|-3.2|
91555442|NCT02307682|182999763|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-5.8|
91555443|NCT02307682|182999763|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.6|-5.2|
91555444|NCT02307682|182999763|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-5.5|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.1|-5.5|
91555445|NCT02307682|182999763|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-5.3|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.4|-5.3|
91555446|NCT02307682|182999763|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.4|-5.7|
91555447|NCT02307682|182999763|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.3|-3.4|
91768116|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.21|TWO_SIDED|95.0|-0.46|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.10|-0.46|0.210
91768117|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.67|-0.17|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.67|<0.001
91768118|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.016|TWO_SIDED|95.0|-0.55|-0.06|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.55|0.016
91768119|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.025|TWO_SIDED|95.0|-0.54|-0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.54|0.025
91768120|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.22|-0.72|<0.001
91768121|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.083|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.48|0.083
91768122|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.355|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.13|0.355
91555448|NCT02307682|182999764|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.5|-2.4|
91555449|NCT02307682|182999764|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-1.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.8|-1.8|
91555450|NCT02307682|182999764|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.8|-4.1|
91555451|NCT02307682|182999764|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-1.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-1.7|
91555452|NCT02307682|182999764|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.3|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||6.5|-2.3|
91555453|NCT02307682|182999764|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.9|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.9|-0.9|
91768123|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.283|TWO_SIDED|95.0|-0.11|0.38|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.38|-0.11|0.283
91768124|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.712|TWO_SIDED|95.0|-0.29|0.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.20|-0.29|0.712
91555454|NCT02307682|182999764|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.4|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.0|-5.4|
91555455|NCT02307682|182999764|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.2|-6.2|
91555456|NCT02307682|182999764|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-5.4|
91555457|NCT02307682|182999764|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.4|-2.9|
91555458|NCT02307682|182999764|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.9|-5.2|
91768125|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.877|TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.27|-0.23|0.877
91555459|NCT02307682|182999764|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.4|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||8.8|-1.4|
91555460|NCT02307682|182999764|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-6.8|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-6.8|
91555461|NCT02307682|182999764|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.7|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.8|-4.7|
91768126|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.195|TWO_SIDED|95.0|-0.41|0.08|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.41|0.195
91555462|NCT02307682|182999764|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.4|-5.0|
91555463|NCT02307682|182999764|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-6.1|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-6.1|
91555464|NCT02307682|182999764|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.8|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.7|-1.8|
91555465|NCT02307682|182999764|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-2.7|
91555466|NCT02307682|182999764|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.9|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.0|-5.9|
91555467|NCT02307682|182999764|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.9|-4.7|
91555468|NCT02307682|182999764|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.5|-5.7|
91768127|NCT03084796|183425153|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.15|TWO_SIDED|95.0|-0.43|0.07|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.07|-0.43|0.150
91555469|NCT02307682|182999764|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.3|-6.5|
91555470|NCT02307682|182999764|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.9|-2.7|
91555471|NCT02307682|182999764|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.3|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.4|-4.3|
91555472|NCT02307682|182999764|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.3|-4.6|
91555473|NCT02307682|182999764|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.6|-3.9|
91555474|NCT02307682|182999764|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-4.0|
91555475|NCT02307682|182999764|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-3.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-3.8|
91768128|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.967||||0.016|TWO_SIDED|95.0|-1.753|-0.181|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.181|-1.753|0.016
91768129|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.039|TWO_SIDED|95.0|-1.606|-0.043|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.043|-1.606|0.039
91768130|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.227||||0.002|TWO_SIDED|95.0|-2.012|-0.441|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.441|-2.012|0.002
91768131|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.949||||0.018|TWO_SIDED|95.0|-1.733|-0.164|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.164|-1.733|0.018
91555476|NCT02307682|182999764|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.5|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.6|-4.5|
91555477|NCT02307682|182999764|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.8|-3.8|
91768132|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.566||||0.169|TWO_SIDED|95.0|-1.374|0.242|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.242|-1.374|0.169
91555478|NCT02307682|182999764|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-2.9|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.3|-2.9|
91555479|NCT02307682|182999764|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.8|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-2.8|
91555480|NCT02307682|182999764|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-5.5|
91555481|NCT02307682|182999764|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.1|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.3|-5.1|
91555482|NCT02307682|182999764|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||6.7|-4.3|
91555483|NCT02307682|182999764|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-5.2|
91555484|NCT02307682|182999764|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-4.6|
91555485|NCT02307682|182999764|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.3|-4.7|
91555486|NCT02307682|182999764|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
91555487|NCT02307682|182999764|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
91555488|NCT02307682|182999764|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.7|-3.1|
91555489|NCT02307682|182999764|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.9|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.7|-2.9|
91768133|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.72|TWO_SIDED|95.0|-0.638|0.923|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.923|-0.638|0.720
91555490|NCT02307682|182999764|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.5|
91555491|NCT02307682|182999764|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.6|
91555492|NCT02307682|182999764|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.5|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.9|-4.5|
91555493|NCT02307682|182999764|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.4|-4.5|
91555494|NCT02307682|182999764|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.1|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.7|-3.1|
91555495|NCT02307682|182999764|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-4.7|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.2|-4.7|
91555496|NCT02307682|182999765|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-7.7|
91768134|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.515|TWO_SIDED|95.0|-1.043|0.523|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.523|-1.043|0.515
91555497|NCT02307682|182999765|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.8|-8.5|
91555498|NCT02307682|182999765|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.9|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.6|-8.9|
91555499|NCT02307682|182999765|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.6|-7.7|
91555500|NCT02307682|182999765|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.9|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-8.9|
91555501|NCT02307682|182999765|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.0|-10.0|
91555502|NCT02307682|182999765|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.3|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.5|-6.3|
91555503|NCT02307682|182999765|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.4|-6.2|
91555504|NCT02307682|182999765|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.4|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.0|-10.4|
91768135|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.963|TWO_SIDED|95.0|-0.764|0.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.800|-0.764|0.963
91768136|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.311|TWO_SIDED|95.0|-1.182|0.377|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.377|-1.182|0.311
91555505|NCT02307682|182999765|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.4|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-9.4|
91555506|NCT02307682|182999765|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.6|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.9|-4.6|
91555507|NCT02307682|182999765|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||5.7|-6.6|
91555508|NCT02307682|182999765|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.5|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.7|-6.5|
91555509|NCT02307682|182999765|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.4|-4.9|
91555510|NCT02307682|182999765|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.5|-3.9|
91555511|NCT02307682|182999765|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.0|11.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||11.5|-1.0|
91768137|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.754|TWO_SIDED|95.0|-0.903|0.654|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.654|-0.903|0.754
91555512|NCT02307682|182999765|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.4|-8.5|
91555513|NCT02307682|182999765|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-6.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.4|-6.0|
91555514|NCT02307682|182999765|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.4|-5.2|
91555515|NCT02307682|182999765|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.0|-7.4|
91555516|NCT02307682|182999765|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.5|-8.8|
91555517|NCT02307682|182999765|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.4|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-8.4|
91555518|NCT02307682|182999765|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.5|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.3|-9.5|
91555519|NCT02307682|182999765|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.6|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.6|-8.6|
91555520|NCT02307682|182999765|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-8.8|
91555521|NCT02307682|182999765|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.1|-6.8|
91555522|NCT02307682|182999765|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-5.9|
91555523|NCT02307682|182999765|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.0|-6.6|
91555524|NCT02307682|182999765|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-5.7|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.4|-5.7|
91555525|NCT02307682|182999765|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.1|-9.0|
91555526|NCT02307682|182999765|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic|||Week 64||5.5|-7.2|
91555527|NCT02307682|182999765|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-6.6|
91555528|NCT02307682|182999765|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.3|-4.3|
91555529|NCT02307682|182999765|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.3|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.1|-6.3|
91555530|NCT02307682|182999765|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-7.2|
91555531|NCT02307682|182999765|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.5|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-8.5|
91555532|NCT02307682|182999765|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-2.4|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||10.2|-2.4|
91555533|NCT02307682|182999765|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.1|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.8|-5.1|
91555534|NCT02307682|182999765|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-2.5|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.6|-2.5|
91555535|NCT02307682|182999765|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-3.5|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.0|-3.5|
91555536|NCT02307682|182999765|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.0|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.0|-3.0|
91555537|NCT02307682|182999765|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.4|-5.8|
91555538|NCT02307682|182999765|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-6.6|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.5|-6.6|
91555539|NCT02307682|182999765|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.1|-6.0|
91555540|NCT02307682|182999765|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.8|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||9.5|-2.8|
91768138|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.278||||0.485|TWO_SIDED|95.0|-0.503|1.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.060|-0.503|0.485
91768139|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.349||||0.005|TWO_SIDED|95.0|-2.294|-0.403|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.403|-2.294|0.005
91555541|NCT02307682|182999765|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-4.3|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-4.3|
91555542|NCT02307682|182999765|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.8|-4.7|
91555543|NCT02307682|182999765|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||9.0|-3.8|
91555544|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-24.2|8.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||8.4|-24.2|
91768140|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.159||||0.016|TWO_SIDED|95.0|-2.1|-0.218|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.218|-2.100|0.016
91555545|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-31.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-1.1|-31.9|
91555546|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-30.4|3.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||3.0|-30.4|
91555547|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-35.0|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-2.9|-35.0|
91555548|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.3|-3.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||-3.1|-36.3|
91555549|NCT02307682|182999766|OTHER||Least Squares Mean Difference|-24.5|STANDARD_ERROR_OF_MEAN|8.24|||TWO_SIDED|95.0|-40.7|-8.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-8.3|-40.7|
91555550|NCT02307682|182999766|SUPERIORITY||Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|9.24||0.0159|TWO_SIDED|95.0|-38.0|-1.7||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||-1.7|-38.0|0.0159
91555551|NCT02307682|182999766|SUPERIORITY||Least Squares Mean Difference|-27.8|STANDARD_ERROR_OF_MEAN|8.8||0.0008|TWO_SIDED|95.0|-45.1|-10.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-10.5|-45.1|0.0008
91555552|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|8.69|||TWO_SIDED|95.0|-11.8|22.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||22.3|-11.8|
91555553|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-14.1|20.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||20.5|-14.1|
91555554|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-44.3|-7.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||-7.2|-44.3|
91555555|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-29.6|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-47.5|-11.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-11.6|-47.5|
91555556|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.96|||TWO_SIDED|95.0|-29.2|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||5.9|-29.2|
91555557|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|8.98|||TWO_SIDED|95.0|-29.8|5.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||5.5|-29.8|
91555558|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|9.91|||TWO_SIDED|95.0|-39.6|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||-0.7|-39.6|
91768141|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.466||||0.003|TWO_SIDED|95.0|-2.416|-0.516|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.516|-2.416|0.003
91555559|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-42.1|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-4.2|-42.1|
91555560|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-35.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.7|-35.5|
91555561|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|9.14|||TWO_SIDED|95.0|-37.6|-1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-1.7|-37.6|
91555562|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|9.83|||TWO_SIDED|95.0|-46.6|-8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||-8.0|-46.6|
91555563|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-48.2|-10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-10.9|-48.2|
91555564|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|9.27|||TWO_SIDED|95.0|-27.5|8.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||8.9|-27.5|
91555565|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-30.3|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.5|-30.3|
91555566|NCT02307682|182999766|SUPERIORITY||Least Squares Mean Difference|-23.9|STANDARD_ERROR_OF_MEAN|9.79||0.0075|TWO_SIDED|95.0|-43.1|-4.6||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-4.6|-43.1|0.0075
91555567|NCT02307682|182999766|SUPERIORITY||Least Squares Mean Difference|-29.0|STANDARD_ERROR_OF_MEAN|9.47||0.0012|TWO_SIDED|95.0|-47.6|-10.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-10.4|-47.6|0.0012
91768142|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.004|TWO_SIDED|95.0|-2.337|-0.454|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.454|-2.337|0.004
91555568|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|9.17|||TWO_SIDED|95.0|-33.6|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||2.4|-33.6|
91555569|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-33.4|3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||3.3|-33.4|
91555570|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||-1.1|-38.9|
91555571|NCT02307682|182999766|OTHER||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-39.4|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-0.7|-39.4|
91555572|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.0|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||-0.5|-37.0|
91555573|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-31.4|6.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||6.1|-31.4|
91555574|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|95.0|-46.7|-7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||-7.6|-46.7|
91555575|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-22.5|STANDARD_ERROR_OF_MEAN|9.73|||TWO_SIDED|95.0|-41.6|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-3.4|-41.6|
91555576|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-33.8|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||3.9|-33.8|
91555577|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|9.88|||TWO_SIDED|95.0|-32.6|6.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||6.2|-32.6|
91555578|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.89|||TWO_SIDED|95.0|-49.3|-10.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||-10.5|-49.3|
91555579|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-46.0|-6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-6.8|-46.0|
91555580|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.2|-0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||-0.4|-38.2|
91555581|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-35.0|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||3.7|-35.0|
91555582|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.34|||TWO_SIDED|95.0|-45.0|-4.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||-4.5|-45.0|
91555583|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|10.32|||TWO_SIDED|95.0|-43.9|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-3.4|-43.9|
91555584|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.65|||TWO_SIDED|95.0|-38.4|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||-0.5|-38.4|
91555585|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|95.0|-31.5|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||8.0|-31.5|
91555586|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|10.16|||TWO_SIDED|95.0|-47.3|-7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||-7.4|-47.3|
91555587|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|10.22|||TWO_SIDED|95.0|-44.3|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-4.2|-44.3|
91555588|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-34.2|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||3.9|-34.2|
91555589|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-12.5|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-32.1|7.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||7.1|-32.1|
91555590|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-50.6|-11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-11.3|-50.6|
91555591|NCT02307682|182999766|OTHER|Treatment difference|Least Squares Mean Difference|-26.0|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-46.2|-5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-5.9|-46.2|
91555592|NCT02307682|182999767|SUPERIORITY||Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.29||0.0183|TWO_SIDED|95.0|-37.7|-1.2||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-1.2|-37.7|0.0183
91555593|NCT02307682|182999767|SUPERIORITY||Least Squares Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.19||0.0075|TWO_SIDED|95.0|-40.4|-4.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-4.4|-40.4|0.0075
91555594|NCT02307682|182999768|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.76|||TWO_SIDED|95.0|-42.4|-4.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-4.1|-42.4|
91555595|NCT02307682|182999768|OTHER|Treatment difference|Least Squares Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-38.3|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-38.3|
91555596|NCT02307682|182999769|OTHER|Treatment difference|Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-32.6|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||0.7|-32.6|
91555597|NCT02307682|182999769|OTHER|Treatment difference|Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.5|-3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-3.3|-36.5|
91555598|NCT02307682|182999769|OTHER|Treatment difference|Least Squares Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-36.4|-1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||-1.5|-36.4|
91555599|NCT02307682|182999769|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.93|||TWO_SIDED|95.0|-36.9|-1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-1.8|-36.9|
91555600|NCT02307682|182999770|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||0.1|-0.8|
91555601|NCT02307682|182999770|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-0.2|-1.0|
91768143|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.097|TWO_SIDED|95.0|-1.797|0.15|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.150|-1.797|0.097
91768144|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.69|TWO_SIDED|95.0|-0.746|1.126|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.126|-0.746|0.690
91768145|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.117||||0.808|TWO_SIDED|95.0|-1.061|0.827|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.827|-1.061|0.808
91555602|NCT02307682|182999770|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-0.2|-1.1|
91555603|NCT02307682|182999770|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.9|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.0|-0.9|
91555604|NCT02307682|182999770|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.3|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-0.3|-1.3|
91555605|NCT02307682|182999770|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.1|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-0.3|-1.1|
91555606|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-3.3|17.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||17.5|-3.3|
91555607|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-10.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||10.9|-10.2|
91555608|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-8.4|12.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||12.6|-8.4|
91555609|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-12.5|9.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||9.2|-12.5|
91555610|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.38|||TWO_SIDED|95.0|-11.2|10.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||10.0|-11.2|
91555611|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.55|||TWO_SIDED|95.0|-13.9|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||7.9|-13.9|
91555612|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-11.1|11.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||11.4|-11.1|
91768146|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.922|TWO_SIDED|95.0|-0.983|0.889|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.889|-0.983|0.922
91768147|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.307||||0.522|TWO_SIDED|95.0|-1.248|0.634|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.634|-1.248|0.522
91768148|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.237||||0.618|TWO_SIDED|95.0|-1.17|0.696|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.696|-1.170|0.618
91555613|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-16.1|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.5|-16.1|
91555614|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|9.3|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-1.6|20.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||20.3|-1.6|
91768149|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.884|TWO_SIDED|95.0|-0.871|1.012|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.012|-0.871|0.884
91555615|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-3.4|18.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||18.5|-3.4|
91555616|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.68|||TWO_SIDED|95.0|-14.7|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||7.6|-14.7|
91555617|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-17.9|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||5.3|-17.9|
91555618|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|95.0|-8.8|12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||12.9|-8.8|
91768150|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.158||||0.006|TWO_SIDED|95.0|-1.978|-0.337|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.337|-1.978|0.006
91555619|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.7|13.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||13.8|-8.7|
91555620|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.4|14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||14.1|-8.4|
91555621|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.7|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||11.5|-11.7|
91555622|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-8.8|13.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||13.6|-8.8|
91555623|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-12.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||10.9|-12.2|
91555624|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|5.71|||TWO_SIDED|95.0|-10.7|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||11.7|-10.7|
91555625|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-15.0|7.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||7.8|-15.0|
91555626|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62|||TWO_SIDED|95.0|-6.1|15.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||15.9|-6.1|
91555627|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.0|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||13.1|-10.0|
91555628|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-10.5|12.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||12.1|-10.5|
91555629|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.93|||TWO_SIDED|95.0|-12.2|11.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||11.1|-12.2|
91555630|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|5.77|||TWO_SIDED|95.0|-9.5|13.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||13.2|-9.5|
91555631|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-10.6|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||13.1|-10.6|
91555632|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.6|12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||12.4|-10.6|
91555633|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-10.4|13.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||13.5|-10.4|
91555634|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-11.9|11.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||11.2|-11.9|
91555635|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-9.7|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||14.6|-9.7|
91555636|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-11.7|11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||11.3|-11.7|
91555637|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-12.2|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||11.7|-12.2|
91555638|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-9.3|13.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||13.9|-9.3|
91555639|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-9.8|14.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||14.0|-9.8|
91555640|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-14.5|8.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||8.7|-14.5|
91555641|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|-13.7|10.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||10.1|-13.7|
91555642|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-10.0|13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||13.7|-10.0|
91555643|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.13|||TWO_SIDED|95.0|-12.2|11.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||11.8|-12.2|
91555644|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-9.1|14.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||14.7|-9.1|
91555645|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|6.01|||TWO_SIDED|95.0|-11.3|12.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||12.3|-11.3|
91555646|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-11.9|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||11.5|-11.9|
91555647|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-12.0|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||11.7|-12.0|
91555648|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-13.2|9.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||9.8|-13.2|
91555649|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-12.6|11.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||11.0|-12.6|
91555650|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-9.8|13.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||13.3|-9.8|
91555651|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-11.1|12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||12.8|-11.1|
91555652|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-15.6|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||7.6|-15.6|
91555653|NCT02307682|182999771|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-15.8|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||8.0|-15.8|
91555654|NCT02307682|182999772|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.4|-3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-3.3|-16.4|
91555655|NCT02307682|182999772|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-21.3|-7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-7.3|-21.3|
91555656|NCT02307682|182999772|OTHER||Difference in proportions|-8.4|||||TWO_SIDED|95.0|-14.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-14.6|
91555657|NCT02307682|182999772|OTHER||Difference in proportions|-15.0|||||TWO_SIDED|95.0|-20.9|-9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-9.5|-20.9|
91555658|NCT02307682|182999772|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.8|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.4|-13.8|
91555659|NCT02307682|182999772|OTHER||Difference in proportions|-14.0|||||TWO_SIDED|95.0|-18.9|-8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-8.7|-18.9|
91555660|NCT02307682|182999772|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-16.8|-3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-3.7|-16.8|
91555661|NCT02307682|182999772|OTHER||Difference in proportions|-19.7|||||TWO_SIDED|95.0|-25.8|-13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-13.4|-25.8|
91555662|NCT02307682|182999772|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.0|
91555663|NCT02307682|182999772|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.3|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.9|-4.3|
91768151|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.992||||0.017|TWO_SIDED|95.0|-1.808|-0.175|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.175|-1.808|0.017
91555664|NCT02307682|182999772|OTHER||Difference in proportions|-12.7|||||TWO_SIDED|95.0|-19.1|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-6.0|-19.1|
91768152|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.346||||0.001|TWO_SIDED|95.0|-2.168|-0.524|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.524|-2.168|0.001
91555665|NCT02307682|182999772|OTHER||Difference in proportions|-23.4|||||TWO_SIDED|95.0|-29.7|-17.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-17.6|-29.7|
91555666|NCT02307682|182999772|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.4|-8.7|
91555667|NCT02307682|182999772|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-11.2|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.4|-11.2|
91555668|NCT02307682|182999772|OTHER||Difference in proportions|-7.7|||||TWO_SIDED|95.0|-14.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-1.0|-14.3|
91555669|NCT02307682|182999772|OTHER||Difference in proportions|-12.4|||||TWO_SIDED|95.0|-19.3|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-6.2|-19.3|
91555670|NCT02307682|182999772|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.2|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.2|-13.2|
91555671|NCT02307682|182999772|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-15.9|-4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-4.9|-15.9|
91555672|NCT02307682|182999772|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.5|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||0.9|-11.5|
91555673|NCT02307682|182999772|OTHER||Difference in proportions|-11.4|||||TWO_SIDED|95.0|-17.7|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.6|-17.7|
91555674|NCT02307682|182999772|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.1|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.7|-5.1|
91555675|NCT02307682|182999772|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.7|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||2.4|-8.7|
91555676|NCT02307682|182999772|OTHER||Difference in proportions|-11.6|||||TWO_SIDED|95.0|-17.8|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-5.5|-17.8|
91555677|NCT02307682|182999772|OTHER||Difference in proportions|-15.6|||||TWO_SIDED|95.0|-21.2|-9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-9.7|-21.2|
91555678|NCT02307682|182999772|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-8.0|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.0|-8.0|
91555679|NCT02307682|182999772|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-13.7|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||-3.4|-13.7|
91555680|NCT02307682|182999772|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.6|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.7|-12.6|
91555681|NCT02307682|182999772|OTHER||Difference in proportions|-9.6|||||TWO_SIDED|95.0|-16.0|-3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-3.8|-16.0|
91555682|NCT02307682|182999772|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.9|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||0.7|-9.9|
91555683|NCT02307682|182999772|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.9|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-3.4|-13.9|
91555684|NCT02307682|182999772|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-13.1|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.2|-13.1|
91555685|NCT02307682|182999772|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-17.8|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-6.0|-17.8|
91555686|NCT02307682|182999772|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.5|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-2.5|
91555687|NCT02307682|182999772|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-6.7|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.7|-6.7|
91555688|NCT02307682|182999772|OTHER||Difference in proportions|-7.5|||||TWO_SIDED|95.0|-12.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.6|-12.8|
91555689|NCT02307682|182999772|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-18.2|-7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-7.0|-18.2|
91555690|NCT02307682|182999772|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.5|-7.0|
91768153|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-1.172||||0.005|TWO_SIDED|95.0|-1.991|-0.353|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.353|-1.991|0.005
91768154|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.695||||0.107|TWO_SIDED|95.0|-1.539|0.149|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.149|-1.539|0.107
91555691|NCT02307682|182999772|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.7|-11.4|
91555692|NCT02307682|182999772|OTHER||Difference in proportions|-6.1|||||TWO_SIDED|95.0|-11.8|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.1|-11.8|
91555693|NCT02307682|182999772|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.0|-6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-6.4|-17.0|
91555694|NCT02307682|182999772|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.1|-10.1|
91555695|NCT02307682|182999772|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.0|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.0|-10.0|
91555696|NCT02307682|182999772|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.7|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.5|-11.7|
91555697|NCT02307682|182999772|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.3|-6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-6.3|-17.3|
91555698|NCT02307682|182999772|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-4.0|
91555699|NCT02307682|182999772|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-9.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||-0.3|-9.7|
91555700|NCT02307682|182999772|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.1|-11.4|
91555701|NCT02307682|182999772|OTHER||Difference in proportions|-11.1|||||TWO_SIDED|95.0|-16.4|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.2|-16.4|
91555702|NCT02307682|182999773|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-7.9|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.9|
91555703|NCT02307682|182999773|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.1|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||7.4|-4.1|
91768155|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.166||||0.689|TWO_SIDED|95.0|-0.648|0.98|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.980|-0.648|0.689
91555704|NCT02307682|182999773|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-10.0|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.3|-10.0|
91555705|NCT02307682|182999773|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||4.5|-7.7|
91555706|NCT02307682|182999773|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.6|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.3|-7.6|
91555707|NCT02307682|182999773|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.8|-5.4|
91555708|NCT02307682|182999773|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.3|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.6|-8.3|
91768156|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.188||||0.651|TWO_SIDED|95.0|-1.007|0.63|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.630|-1.007|0.651
91768157|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.973|TWO_SIDED|95.0|-0.83|0.801|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.801|-0.830|0.973
91555709|NCT02307682|182999773|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.9|-10.0|
91555710|NCT02307682|182999773|OTHER||Difference in proportions|10.6|||||TWO_SIDED|95.0|5.0|16.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||16.2|5.0|
91555711|NCT02307682|182999773|OTHER||Difference in proportions|10.0|||||TWO_SIDED|95.0|4.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||15.4|4.7|
91555712|NCT02307682|182999773|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.8|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.7|-9.8|
91555713|NCT02307682|182999773|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-14.9|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.0|-14.9|
91555714|NCT02307682|182999773|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.4|-2.1|
91555715|NCT02307682|182999773|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.1|-6.3|
91555716|NCT02307682|182999773|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-5.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||6.1|-5.8|
91555717|NCT02307682|182999773|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-8.4|
91555718|NCT02307682|182999773|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.4|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-6.4|
91555719|NCT02307682|182999773|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.8|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.0|-7.8|
91555720|NCT02307682|182999773|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.6|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.7|-9.6|
91555721|NCT02307682|182999773|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-10.2|
91555722|NCT02307682|182999773|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-1.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.9|-1.0|
91555723|NCT02307682|182999773|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.3|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.5|-3.3|
91768158|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.355||||0.393|TWO_SIDED|95.0|-1.17|0.461|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.461|-1.170|0.393
91768159|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|-0.181||||0.663|TWO_SIDED|95.0|-0.993|0.632|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.632|-0.993|0.663
91555724|NCT02307682|182999773|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.2|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.1|-6.2|
91555725|NCT02307682|182999773|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.5|-6.4|
91555726|NCT02307682|182999773|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.2|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.7|-2.2|
91555727|NCT02307682|182999773|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.4|-3.2|
91555728|NCT02307682|182999773|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.5|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.1|-3.5|
91555729|NCT02307682|182999773|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.8|-5.8|
91555730|NCT02307682|182999773|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-6.6|
91555731|NCT02307682|182999773|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.1|-5.8|
91555732|NCT02307682|182999773|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-6.4|
91768160|NCT03084796|183425154|SUPERIORITY||Mean Difference (Final Values)|0.174||||0.676|TWO_SIDED|95.0|-0.643|0.991|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.991|-0.643|0.676
91555733|NCT02307682|182999773|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.6|-8.7|
91555734|NCT02307682|182999773|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|0.3|10.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||10.7|0.3|
91555735|NCT02307682|182999773|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.2|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.2|-3.2|
91555736|NCT02307682|182999773|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-6.1|
91555737|NCT02307682|182999773|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||1.9|-9.0|
91555738|NCT02307682|182999773|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.9|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.1|-1.9|
91768161|NCT02741245|183425213|OTHER||Difference in M-estimates|-35.9|||<|0.001|TWO_SIDED|95.0|-39.9|-32.0|||Shapiro-Wilk test|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach||||-32.0|-39.9|<0.001
91768162|NCT02741245|183425213|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-14.8|||<|0.001|TWO_SIDED|95.0|-18.0|-11.6|||Shapiro-Wilk test|||||-11.6|-18.0|<0.001
91555739|NCT02307682|182999773|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-3.9|
91555740|NCT02307682|182999773|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.7|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-4.7|
91555741|NCT02307682|182999773|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-5.2|
91555742|NCT02307682|182999773|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.3|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.3|-3.3|
91555743|NCT02307682|182999773|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.8|-5.7|
91555744|NCT02307682|182999773|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-1.7|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||9.7|-1.7|
91555745|NCT02307682|182999773|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.3|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.6|-5.3|
91555746|NCT02307682|182999773|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.3|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.9|-1.3|
91555747|NCT02307682|182999773|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.3|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.0|-4.3|
91555748|NCT02307682|182999773|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.2|-6.4|
91555749|NCT02307682|182999773|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-10.8|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.9|-10.8|
91555750|NCT02307682|182999774|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.7|
91555751|NCT02307682|182999774|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.4|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.4|-11.4|
91555752|NCT02307682|182999774|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.3|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.3|
91555753|NCT02307682|182999774|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-9.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.8|
91555754|NCT02307682|182999774|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.5|-1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.5|-11.5|
91768163|NCT02741245|183425213|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-41.8|||<|0.001|TWO_SIDED|95.0|-45.8|-37.9|||Shapiro-Wilk test|||||-37.9|-45.8|<0.001
91768164|NCT02741245|183425213|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Differecne in M-estimates|-13.3|||<|0.001|TWO_SIDED|95.0|-16.6|-10.1|||Shapiro-Wilk test|||||-10.1|-16.6|<0.001
91768165|NCT03799341|183425235|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||||||0.177
91555755|NCT02307682|182999774|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-12.8|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.3|-12.8|
91555756|NCT02307682|182999774|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.8|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-1.1|-11.8|
91555757|NCT02307682|182999774|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-14.4|-2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.9|-14.4|
91555758|NCT02307682|182999774|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||8.3|-2.8|
91555759|NCT02307682|182999774|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.5|-3.4|
91555760|NCT02307682|182999774|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-9.7|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||0.9|-9.7|
91555761|NCT02307682|182999774|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.3|-1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-1.3|-12.3|
91555762|NCT02307682|182999774|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.2|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.2|-4.2|
91768166|NCT03799341|183425236|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
91768167|NCT03799341|183425237|OTHER|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
91768168|NCT03799341|183425238|OTHER|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
91768169|NCT03799341|183425239|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
91768170|NCT03799341|183425240|OTHER|||||||0.976|||||||Wilcoxon (Mann-Whitney)|||||||0.976
91555763|NCT02307682|182999774|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-8.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||1.7|-8.4|
91555764|NCT02307682|182999774|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-6.2|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.2|-6.2|
91768171|NCT03799341|183425241|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.920
91768172|NCT03799341|183425242|OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||||||0.873
91768173|NCT03799341|183425243|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
91768174|NCT03799341|183425243|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
91768175|NCT03799341|183425243|OTHER|||||||0.022|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.022
91768176|NCT03799341|183425243|OTHER|||||||0.024|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.024
91555765|NCT02307682|182999774|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-7.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.4|-7.5|
91555766|NCT02307682|182999774|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.7|-9.5|
91555767|NCT02307682|182999774|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.6|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.6|-10.6|
91555768|NCT02307682|182999774|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.3|-10.2|
91555769|NCT02307682|182999774|OTHER||Difference in proportions|-6.3|||||TWO_SIDED|95.0|-12.2|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.8|-12.2|
91555770|NCT02307682|182999774|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.6|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.3|-6.6|
91555771|NCT02307682|182999774|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||0.1|-10.0|
91555772|NCT02307682|182999774|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.4|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||1.4|-9.4|
91555773|NCT02307682|182999774|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.6|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-2.7|-13.6|
91555774|NCT02307682|182999774|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-5.1|
91555775|NCT02307682|182999774|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.8|-6.2|
91555776|NCT02307682|182999774|OTHER||Difference in proportions|-4.2|||||TWO_SIDED|95.0|-9.4|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||1.2|-9.4|
91555777|NCT02307682|182999774|OTHER||Difference in proportions|-6.2|||||TWO_SIDED|95.0|-11.5|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.8|-11.5|
91555778|NCT02307682|182999774|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.3|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.0|-7.3|
91555779|NCT02307682|182999774|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.9|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.1|-7.9|
91555780|NCT02307682|182999774|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-10.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.7|-10.5|
91555781|NCT02307682|182999774|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.5|-1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.8|-12.5|
91555782|NCT02307682|182999774|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-6.0|
91555783|NCT02307682|182999774|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.9|-6.3|
91555784|NCT02307682|182999774|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.1|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-0.4|-10.1|
91555785|NCT02307682|182999774|OTHER||Difference in proportions|-7.3|||||TWO_SIDED|95.0|-12.2|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-2.3|-12.2|
91555786|NCT02307682|182999774|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.3|-5.2|
91555787|NCT02307682|182999774|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.5|-5.8|
91555788|NCT02307682|182999774|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-8.4|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.8|-8.4|
91555789|NCT02307682|182999774|OTHER||Difference in proportions|-3.3|||||TWO_SIDED|95.0|-8.5|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.5|-8.5|
91555790|NCT02307682|182999774|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-9.8|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.2|-9.8|
91555791|NCT02307682|182999774|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.7|-10.4|
91555792|NCT02307682|182999774|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-7.4|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.0|-7.4|
91555793|NCT02307682|182999774|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.0|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-1.1|-11.0|
91555794|NCT02307682|182999774|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.9|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-4.9|
91555795|NCT02307682|182999774|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-7.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||1.4|-7.6|
91555796|NCT02307682|182999774|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.1|-5.3|
91555797|NCT02307682|182999774|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-8.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.8|-8.5|
91768177|NCT03799341|183425244|OTHER|||||||0.973|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of Contingency Management session attendance. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.973
91555798|NCT02307682|182999775|OTHER||Difference in proportions|-6.7|||||TWO_SIDED|95.0|-14.1|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.1|
91555799|NCT02307682|182999775|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-15.3|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-15.3|
91555800|NCT02307682|182999775|OTHER||Difference in proportions|-9.3|||||TWO_SIDED|95.0|-16.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-16.6|
91555801|NCT02307682|182999775|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.7|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-5.4|-19.7|
91555802|NCT02307682|182999775|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-14.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.6|-14.8|
91555803|NCT02307682|182999775|OTHER||Difference in proportions|-10.2|||||TWO_SIDED|95.0|-17.4|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-3.9|-17.4|
91555804|NCT02307682|182999775|SUPERIORITY||Difference in proportions|-10.2||||0.003|TWO_SIDED|95.0|-17.3|-2.5||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.5|-17.3|0.0030
91555805|NCT02307682|182999775|SUPERIORITY||Difference in proportions|-18.2|||<|0.0001|TWO_SIDED|95.0|-25.3|-10.9||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-10.9|-25.3|<0.0001
91555806|NCT02307682|182999775|OTHER||Difference in proportions|12.0|||||TWO_SIDED|95.0|5.2|19.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||19.0|5.2|
91555807|NCT02307682|182999775|OTHER||Difference in proportions|11.1|||||TWO_SIDED|95.0|3.8|18.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||18.2|3.8|
91768178|NCT03799341|183425244|OTHER|||||||0.662|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of self-reported cocaine abstinence during the 12-week treatment interval. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.662
91555808|NCT02307682|182999775|OTHER||Difference in proportions|-10.6|||||TWO_SIDED|95.0|-17.7|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-17.7|
91555809|NCT02307682|182999775|OTHER||Difference in proportions|-23.2|||||TWO_SIDED|95.0|-30.5|-16.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-16.1|-30.5|
91555810|NCT02307682|182999775|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.0|-4.8|
91555811|NCT02307682|182999775|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.8|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-11.8|
91555812|NCT02307682|182999775|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-12.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.1|-12.0|
91555813|NCT02307682|182999775|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-18.0|-3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.2|-18.0|
91555814|NCT02307682|182999775|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.8|-12.5|
91555815|NCT02307682|182999775|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-16.2|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.4|-16.2|
91555816|NCT02307682|182999775|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-15.7|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.6|-15.7|
91555817|NCT02307682|182999775|OTHER||Difference in proportions|-13.0|||||TWO_SIDED|95.0|-20.5|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.5|-20.5|
91555818|NCT02307682|182999775|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.0|-0.8|
91555819|NCT02307682|182999775|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.5|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.6|-7.5|
91555820|NCT02307682|182999775|SUPERIORITY||Difference in proportions|-10.5||||0.002|TWO_SIDED|95.0|-17.4|-3.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.3|-17.4|0.0020
91555821|NCT02307682|182999775|SUPERIORITY||Difference in proportions|-13.5||||0.0001|TWO_SIDED|95.0|-20.7|-6.1||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-6.1|-20.7|0.0001
91555822|NCT02307682|182999775|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-5.4|
91555823|NCT02307682|182999775|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||1.2|-11.8|
91768179|NCT03799341|183425245|OTHER|||||||0.878|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of Contingency Management session attendance. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.878
91768180|NCT03799341|183425245|OTHER|||||||0.645|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of self-reported cocaine abstinence during treatment. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.645
91555824|NCT02307682|182999775|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.3|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.7|-10.3|
91555825|NCT02307682|182999775|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.1|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.4|-14.1|
91555826|NCT02307682|182999775|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.3|-10.1|
91555827|NCT02307682|182999775|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-14.0|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.6|-14.0|
91768181|NCT01116648|183425246|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED||||||||Cediranib|||||
91555828|NCT02307682|182999775|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-14.7|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-0.1|-14.7|
91555829|NCT02307682|182999775|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.5|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-5.4|-19.5|
91555830|NCT02307682|182999775|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.3|13.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||13.5|0.3|
91555831|NCT02307682|182999775|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-4.9|
91555832|NCT02307682|182999775|OTHER||Difference in proportions|-8.9|||||TWO_SIDED|95.0|-15.7|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.7|-15.7|
91555833|NCT02307682|182999775|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-19.8|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-5.6|-19.8|
91768182|NCT01116648|183425246|OTHER||Maximum Tolerated Dose (mg BID)|200.0|||||TWO_SIDED||||||||Olaparib|||||
91555834|NCT02307682|182999775|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-5.9|
91555835|NCT02307682|182999775|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||2.6|-9.8|
91555836|NCT02307682|182999775|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-11.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||2.5|-11.2|
91555837|NCT02307682|182999775|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-15.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-1.0|-15.3|
91555838|NCT02307682|182999775|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.9|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.6|-8.9|
91555839|NCT02307682|182999775|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.2|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||1.7|-11.2|
91555840|NCT02307682|182999775|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.8|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.7|-10.8|
91555841|NCT02307682|182999775|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-17.3|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-3.5|-17.3|
91555842|NCT02307682|182999775|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.3|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.0|-2.3|
91768183|NCT01116648|183425248|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.006|TWO_SIDED|95.0|0.3|0.83|||Kaplan-Meier Plot|||||0.83|0.30|0.006
91768184|NCT05579977|183425301|OTHER||LS Mean Difference|-0.95|||<|0.0001|TWO_SIDED|90.0|-1.2|-0.7|||Mixed Models Analysis|||||-0.70|-1.20|<.0001
91768185|NCT05579977|183425301|OTHER||LS Mean Difference|-1.3|||<|0.0001|TWO_SIDED|90.0|-1.55|-1.04|||Mixed Models Analysis|||||-1.04|-1.55|<.0001
91768186|NCT05579977|183425301|OTHER||LS Mean Difference|-1.37|||<|0.0001||90.0|-1.62|-1.11|||Mixed Models Analysis|||||-1.11|-1.62|<.0001
91768187|NCT05579977|183425301|OTHER||LS Mean Difference|-1.26|||<|0.0001|TWO_SIDED|90.0|-1.52|-1.01|||Mixed Models Analysis|||||-1.01|-1.52|<.0001
91768188|NCT05579977|183425301|OTHER||LS Mean Difference|-1.29|||<|0.0001||90.0|-1.55|-1.03|||Mixed Models Analysis|||||-1.03|-1.55|<.0001
91555843|NCT02307682|182999775|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-9.8|
91555844|NCT02307682|182999775|OTHER||Difference in proportions|-6.4|||||TWO_SIDED|95.0|-13.2|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.7|-13.2|
91555845|NCT02307682|182999775|OTHER||Difference in proportions|-12.9|||||TWO_SIDED|95.0|-19.7|-6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.6|-19.7|
91555846|NCT02307682|182999776|SUPERIORITY|||||||0.0574||||||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0574
91555847|NCT02307682|182999776|SUPERIORITY|||||||0.0012||||||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0012
91555848|NCT02307682|182999777|SUPERIORITY||difference in proportions|-6.5||||0.0331|TWO_SIDED|95.0|-13.2|0.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||0.3|-13.2|0.0331
91555849|NCT02307682|182999777|SUPERIORITY||difference in proportions|-10.5||||0.0013|TWO_SIDED|95.0|-17.1|-3.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||-3.5|-17.1|0.0013
91555850|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|0.9|||||TWO_SIDED|95.0|-0.5|2.3||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||2.3|-0.5|
91768189|NCT05579977|183425301|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
91768190|NCT05579977|183425302|OTHER||LS Mean Difference|-2.44||||0.0055|TWO_SIDED|90.0|-3.88|-1.0|||Mixed Models Analysis|||||-1.00|-3.88|0.0055
91768191|NCT05579977|183425302|OTHER||LS Mean Difference|-4.37|||<|0.0001|TWO_SIDED|90.0|-5.84|-2.89|||Mixed Models Analysis|||||-2.89|-5.84|<.0001
91555851|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|0.63|||||TWO_SIDED|95.0|-0.9|2.1||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||2.1|-0.9|
91555852|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|-0.2|||||TWO_SIDED|95.0|-1.8|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.4|-1.8|
91555853|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|-0.26|||||TWO_SIDED|95.0|-1.9|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.4|-1.9|
91555854|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|0.18|||||TWO_SIDED|95.0|-1.6|1.9||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||1.9|-1.6|
91555855|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|-0.12|||||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.7|-1.9|
91555856|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|0.75|||||TWO_SIDED|95.0|-1.2|2.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.7|-1.2|
91555857|NCT02307682|182999778|OTHER|Treatment difference|Least squares mean difference|1.05|||||TWO_SIDED|95.0|-0.9|3.0||Hypothesis testing not pre-specified.|ANCOVA|nalyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||3.0|-0.9|
91768192|NCT05579977|183425302|OTHER||LS Mean Difference|-5.63|||<|0.0001|TWO_SIDED|90.0|-7.07|-4.18|||Mixed Models Analysis|||||-4.18|-7.07|<.0001
91768193|NCT05579977|183425302|OTHER||LS Mean Difference|-5.04|||<|0.0001|TWO_SIDED|90.0|-6.5|-3.58|||Mixed Models Analysis|||||-3.58|-6.50|<.0001
91768194|NCT05579977|183425302|OTHER||LS Mean Difference|-5.42|||<|0.0001|TWO_SIDED|90.0|-6.91|-3.93|||Mixed Models Analysis|||||-3.93|-6.91|<.0001
91768195|NCT05579977|183425305|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
91768196|NCT01420926|183425330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Stratified 1-sided log-rank|||||||0.30
91768197|NCT00932321|183425336|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis tested was the independence (lack of association) of mean number of IB days in Cycles 2-6 across treatment groups.||||||0.311|||||||Cochran-Mantel-Haenszel|Stratified by investigational site.||||||0.311
91768198|NCT04564846|183425337|OTHER||Risk Ratio (RR)|0.974||||0.1628|TWO_SIDED|95.0|0.938|1.011|||Analysis of Covariance||Estimated Difference from Placebo Across All Time Points. Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Comparison to Placebo Across All Time Points||1.011|0.938|0.1628
91555858|NCT03905694|182999792|OTHER|Not applied|Least Squares (LS) Mean|-71.97|||||TWO_SIDED|95.0|-77.52|-66.42|||Mixed model for repeated measures (MMRM)|||Mixed-effect Model Repeated Measures (MMRM) includes scheduled visits (months 3, 4, 5, and 6) and baseline spot urinary oxalate:creatine ratio as fixed effects. Autoregressive (1) was used to model the within-patient error.||-66.42|-77.52|
91555859|NCT03044158|182999821|SUPERIORITY||Rate Ratio (adjusted)|1.56|||||TWO_SIDED|95.0|1.21|2.01||||||||2.01|1.21|
91555860|NCT03044158|182999822|SUPERIORITY||Rate Ratio (adjusted)|1.28|||||TWO_SIDED|95.0|0.99|1.66||||||||1.66|0.99|
91555861|NCT03044158|182999823|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.49|||||TWO_SIDED|95.0|0.39|0.62||||||||0.62|0.39|
91555862|NCT03044158|182999824|SUPERIORITY||Rate Ratio (adjusted)|1.48|||||TWO_SIDED|95.0|1.04|2.12||||||||2.12|1.04|
91555863|NCT03044158|182999825|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.35|||||TWO_SIDED|95.0|0.21|0.56||||||||0.56|0.21|
91555864|NCT03044158|182999826|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.35||||||||1.35|0.44|
91555865|NCT05485805|182999885|OTHER||Geometric LS means|-5.95|||=|0.004|TWO_SIDED|95.0|-9.946|-1.954|||ANCOVA|||||-1.954|-9.946|= 0.004
91555866|NCT05485805|182999885|OTHER||Geometric LS means|6.161|||=|0.003|TWO_SIDED|95.0|2.161|10.161|||ANCOVA|||||10.161|2.161|= 0.003
91555867|NCT05485805|182999885|OTHER||Geometric LS means|25.936|||<|0.001|TWO_SIDED|95.0|20.317|31.556|||ANCOVA|||||31.556|20.317|< 0.001
91555868|NCT05485805|182999885|OTHER||Geometric LS means|-3.476|||=|0.325|TWO_SIDED|95.0|-10.41|3.457|||ANCOVA|||||3.457|-10.41|= 0.325
91555869|NCT05485805|182999885|OTHER||Geometric LS means|0.211|||=|0.918|TWO_SIDED|95.0|-3.798|4.22|||ANCOVA|||||4.22|-3.798|= 0.918
91555870|NCT05485805|182999885|OTHER||Geometric LS means|32.097|||<|0.001|TWO_SIDED|95.0|26.484|37.71|||ANCOVA|||||37.71|26.484|< 0.001
91555871|NCT05485805|182999885|OTHER||Geometric LS means|22.46|||<|0.001|TWO_SIDED|95.0|16.753|28.166|||ANCOVA|||||28.166|16.753|< 0.001
91555872|NCT05485805|182999885|OTHER||Geometric LS means|26.147|||<|0.001|TWO_SIDED|95.0|20.529|31.765|||ANCOVA|||||31.765|20.529|< 0.001
91555873|NCT05485805|182999885|OTHER||Geometric LS means|28.62|||<|0.001|TWO_SIDED|95.0|22.921|34.32|||ANCOVA|||||34.32|22.921|< 0.001
91555874|NCT05485805|182999885|OTHER||Geometric LS means|22.671|||<|0.001|TWO_SIDED|95.0|16.966|28.375|||ANCOVA|||||28.375|16.966|< 0.001
91555875|NCT05485805|182999886|OTHER||Geometric LS means|-1.602|||<|0.001|TWO_SIDED|95.0|-2.548|-0.656|||ANCOVA|||0-2 hours post-dose||-0.656|-2.548|< 0.001
91555876|NCT05485805|182999886|OTHER||Geometric LS means|0.976|||=|0.043|TWO_SIDED|95.0|0.029|1.923|||ANCOVA|||0-2 hours post-dose||1.923|0.029|= 0.043
91555877|NCT05485805|182999886|OTHER||Geometric LS means|6.097|||<|0.001|TWO_SIDED|95.0|4.766|7.427|||ANCOVA|||0-2 hours post-dose||7.427|4.766|< 0.001
91555878|NCT05485805|182999886|OTHER||Geometric LS means|0.31|||=|0.711|TWO_SIDED|95.0|-1.332|1.951|||ANCOVA|||0-2 hours post-dose||1.951|-1.332|= 0.711
91555879|NCT05485805|182999886|OTHER||Geometric LS means|-0.626|||=|0.196|TWO_SIDED|95.0|-1.575|0.323|||ANCOVA|||0-2 hours post-dose||0.323|-1.575|= 0.196
91555880|NCT05485805|182999886|OTHER||Geometric LS means|7.073|||<|0.001|TWO_SIDED|95.0|5.744|8.402|||ANCOVA|||0-2 hours post-dose||8.402|5.744|< 0.001
91555881|NCT05485805|182999886|OTHER||Geometric LS means|6.406|||<|0.001|TWO_SIDED|95.0|5.055|7.757|||ANCOVA|||0-2 hours post-dose||7.757|5.055|< 0.001
91555882|NCT05485805|182999886|OTHER||Geometric LS means|5.471|||<|0.001|TWO_SIDED|95.0|4.141|6.801|||ANCOVA|||0-2 hours post-dose||6.801|4.141|< 0.001
91555883|NCT05485805|182999886|OTHER||Geometric LS means|7.383|||<|0.001|TWO_SIDED|95.0|6.033|8.732|||ANCOVA|||0-2 hours post-dose||8.732|6.033|< 0.001
91555884|NCT05485805|182999886|OTHER||Geometric LS means|5.78|||<|0.001|TWO_SIDED|95.0|4.43|7.131|||ANCOVA|||0-2 hours post-dose||7.131|4.43|< 0.001
91555885|NCT05485805|182999887|OTHER||Geometric LS means|-0.586|||<|0.001|TWO_SIDED|95.0|-0.903|-0.269|||ANCOVA|||0-2 hours post-dose||-0.269|-0.903|< 0.001
91555886|NCT05485805|182999887|OTHER||Geometric LS means|0.454|||=|0.005|TWO_SIDED|95.0|0.136|0.771|||ANCOVA|||0-2 hours post-dose||0.771|0.136|= 0.005
91555887|NCT05485805|182999887|OTHER||Geometric LS means|2.369|||<|0.001|TWO_SIDED|95.0|1.923|2.815|||ANCOVA|||0-2 hours post-dose||2.815|1.923|< 0.001
91555888|NCT05485805|182999887|OTHER||Geometric LS means|-0.169|||=|0.548|TWO_SIDED|95.0|-0.719|0.382|||ANCOVA|||0-2 hours post-dose||0.382|-0.719|= 0.548
91555889|NCT05485805|182999887|OTHER||Geometric LS means|-0.132|||=|0.415|TWO_SIDED|95.0|-0.451|0.186|||ANCOVA|||0-2 hours post-dose||0.186|-0.451|= 0.415
91555890|NCT05485805|182999887|OTHER||Geometric LS means|2.823|||<|0.001|TWO_SIDED|95.0|2.377|3.268|||ANCOVA|||0-2 hours post-dose||3.268|2.377|< 0.001
91555891|NCT05485805|182999887|OTHER||Geometric LS means|2.201|||<|0.001|TWO_SIDED|95.0|1.748|2.654|||ANCOVA|||0-2 hours post-dose||2.654|1.748|< 0.001
91555892|NCT05485805|182999887|OTHER||Geometric LS means|2.237|||<|0.001|TWO_SIDED|95.0|1.791|2.683|||ANCOVA|||0-2 hours post-dose||2.683|1.791|< 0.001
91555893|NCT05485805|182999887|OTHER||Geometric LS means|2.654|||<|0.001|TWO_SIDED|95.0|2.202|3.106|||ANCOVA|||0-2 hours post-dose||3.106|2.202|< 0.001
91555894|NCT05485805|182999887|OTHER||Geometric LS means|2.068|||<|0.001|TWO_SIDED|95.0|1.615|2.521|||ANCOVA|||0-2 hours post-dose||2.521|1.615|< 0.001
91555895|NCT05485805|182999887|OTHER||Geometric LS means|-1.338|||<|0.001|TWO_SIDED|95.0|-2.133|-0.542|||ANCOVA|||0-4 hours post-dose||-0.542|-2.133|< 0.001
91555896|NCT05485805|182999887|OTHER||Geometric LS means|1.016|||=|0.012|TWO_SIDED|95.0|0.22|1.813|||ANCOVA|||0-4 hours post-dose||1.813|0.22|= 0.012
91555897|NCT05485805|182999887|OTHER||Geometric LS means|5.982|||<|0.001|TWO_SIDED|95.0|4.864|7.101|||ANCOVA|||0-4 hours post-dose||7.101|4.864|< 0.001
91555898|NCT05485805|182999887|OTHER||Geometric LS means|-1.048|||=|0.136|TWO_SIDED|95.0|-2.428|0.332|||ANCOVA|||0-4 hours post-dose||0.332|-2.428|= 0.136
91768199|NCT04564846|183425339|OTHER||Risk Ratio (RR)|0.784||||0.0674|TWO_SIDED|95.0|0.605|1.017|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|1.017|0.605|0.0674
91555899|NCT05485805|182999887|OTHER||Geometric LS means|-0.321|||=|0.43|TWO_SIDED|95.0|-1.119|0.477|||ANCOVA|||0-4 hours post-dose||0.477|-1.119|= 0.43
91555900|NCT05485805|182999887|OTHER||Geometric LS means|6.999|||<|0.001|TWO_SIDED|95.0|5.881|8.116|||ANCOVA|||0-4 hours post-dose||8.116|5.881|< 0.001
91555901|NCT05485805|182999887|OTHER||Geometric LS means|4.934|||<|0.001|TWO_SIDED|95.0|3.798|6.07|||ANCOVA|||0-4 hours post-dose||6.07|3.798|< 0.001
91555902|NCT05485805|182999887|OTHER||Geometric LS means|5.661|||<|0.001|TWO_SIDED|95.0|4.543|6.779|||ANCOVA|||0-4 hours post-dose||6.779|4.543|< 0.001
91555903|NCT05485805|182999887|OTHER||Geometric LS means|5.951|||<|0.001|TWO_SIDED|95.0|4.816|7.085|||ANCOVA|||0-4 hours post-dose||7.085|4.816|< 0.001
91768200|NCT04564846|183425340|OTHER|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Risk Ratio, log|1.067||||0.8182|TWO_SIDED|95.0|0.976|1.167|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points.||1.167|0.976|0.8182
91768201|NCT04564846|183425341|OTHER|AUC Parameters analyzed using an Analysis of Covariance model with treatment as the main effect and baseline HbA1c as a covariate.|Risk Ratio, log|1.007||||0.8182|TWO_SIDED|95.0|0.951|1.066|||Analysis of Covariance|||||1.066|0.951|0.8182
91768202|NCT04564846|183425342|OTHER||Analysis of Variance|0.4628|||||TWO_SIDED|||||Parameter analyzed using an Analysis of Variance model with treatment as the main effect.||||||||
91555904|NCT05485805|182999887|OTHER||Geometric LS means|4.613|||<|0.001|TWO_SIDED|95.0|3.478|5.749|||ANCOVA|||0-4 hours post-dose||5.749|3.478|< 0.001
91555905|NCT05485805|182999887|OTHER||Geometric LS means|-1.963|||=|0.003|TWO_SIDED|95.0|-3.254|-0.673|||ANCOVA|||0-6 hours post-dose||-0.673|-3.254|= 0.003
91555906|NCT05485805|182999887|OTHER||Geometric LS means|1.641|||=|0.013|TWO_SIDED|95.0|0.35|2.933|||ANCOVA|||0-6 hours post-dose||2.933|0.35|= 0.013
91555907|NCT05485805|182999887|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.377|11.006|||ANCOVA|||0-6 hours post-dose||11.006|7.377|< 0.001
91555908|NCT05485805|182999887|OTHER||Geometric LS means|-1.642|||=|0.15|TWO_SIDED|95.0|-3.881|0.597|||ANCOVA|||0-6 hours post-dose||0.597|-3.881|= 0.15
91555909|NCT05485805|182999887|OTHER||Geometric LS means|-0.322|||=|0.625|TWO_SIDED|95.0|-1.617|0.972|||ANCOVA|||0-6 hours post-dose||0.972|-1.617|= 0.625
91768203|NCT00762359|183425361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.0989|||<|0.0001|TWO_SIDED|95.0|0.0425|0.23|||Log Rank|||||0.2300|0.0425|<0.0001
91555910|NCT05485805|182999887|OTHER||Geometric LS means|10.833|||<|0.001|TWO_SIDED|95.0|9.02|12.645|||ANCOVA|||0-6 hours post-dose||12.645|9.02|< 0.001
91555911|NCT05485805|182999887|OTHER||Geometric LS means|7.55|||<|0.001|TWO_SIDED|95.0|5.707|9.392|||ANCOVA|||0-6 hours post-dose||9.392|5.707|< 0.001
91555912|NCT05485805|182999887|OTHER||Geometric LS means|8.869|||<|0.001|TWO_SIDED|95.0|7.055|10.683|||ANCOVA|||0-6 hours post-dose||10.683|7.055|< 0.001
91555913|NCT05485805|182999887|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.351|11.031|||ANCOVA|||0-6 hours post-dose||11.031|7.351|< 0.001
91555914|NCT05485805|182999887|OTHER||Geometric LS means|7.228|||<|0.001|TWO_SIDED|95.0|5.386|9.07|||ANCOVA|||0-6 hours post-dose||9.07|5.386|< 0.001
91555915|NCT05485805|182999887|OTHER||Geometric LS means|-2.398|||=|0.009|TWO_SIDED|95.0|-4.185|-0.61|||ANCOVA|||0-8 hours post-dose||-0.61|-4.185|= 0.009
91555916|NCT05485805|182999887|OTHER||Geometric LS means|2.4|||=|0.009|TWO_SIDED|95.0|0.61|4.189|||ANCOVA|||0-8 hours post-dose||4.189|0.61|= 0.009
91555917|NCT05485805|182999887|OTHER||Geometric LS means|11.898|||<|0.001|TWO_SIDED|95.0|9.384|14.412|||ANCOVA|||0-8 hours post-dose||14.412|9.384|< 0.001
91555918|NCT05485805|182999887|OTHER||Geometric LS means|-2.225|||=|0.159|TWO_SIDED|95.0|-5.327|0.877|||ANCOVA|||0-8 hours post-dose||0.877|-5.327|= 0.159
91555919|NCT05485805|182999887|OTHER||Geometric LS means|0.002|||=|0.998|TWO_SIDED|95.0|-1.792|1.795|||ANCOVA|||0-8 hours post-dose||1.795|-1.792|= 0.998
91555920|NCT05485805|182999887|OTHER||Geometric LS means|14.298|||<|0.001|TWO_SIDED|95.0|11.787|16.809|||ANCOVA|||0-8 hours post-dose||16.809|11.787|< 0.001
91555921|NCT05485805|182999887|OTHER||Geometric LS means|9.673|||<|0.001|TWO_SIDED|95.0|7.12|12.226|||ANCOVA|||0-8 hours post-dose||12.226|7.12|< 0.001
91555922|NCT05485805|182999887|OTHER||Geometric LS means|11.9|||<|0.001|TWO_SIDED|95.0|9.387|14.413|||ANCOVA|||0-8 hours post-dose||14.413|9.387|< 0.001
91768204|NCT00762359|183425362|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91768205|NCT00762359|183425363|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91768206|NCT00762359|183425364|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
91768207|NCT00762359|183425365|SUPERIORITY_OR_OTHER|||||||0.0433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0433
91768208|NCT00762359|183425367|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91768209|NCT00762359|183425368|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
91768210|NCT00762359|183425369|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0025
91768211|NCT00762359|183425370|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0010
91768212|NCT00762359|183425372|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
91768213|NCT00762359|183425373|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6148
91768214|NCT00762359|183425374|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8050
91555923|NCT05485805|182999887|OTHER||Geometric LS means|12.073|||<|0.001|TWO_SIDED|95.0|9.523|14.623|||ANCOVA|||0-8 hours post-dose||14.623|9.523|< 0.001
91555924|NCT05485805|182999887|OTHER||Geometric LS means|9.675|||<|0.001|TWO_SIDED|95.0|7.123|12.227|||ANCOVA|||0-8 hours post-dose||12.227|7.123|< 0.001
91555925|NCT05485805|182999887|OTHER||Geometric LS means|-2.949|||=|0.043|TWO_SIDED|95.0|-5.803|-0.095|||ANCOVA|||0-12 hours post-dose||-0.095|-5.803|= 0.043
91555926|NCT05485805|182999887|OTHER||Geometric LS means|3.694|||=|0.011|TWO_SIDED|95.0|0.837|6.55|||ANCOVA|||0-12 hours post-dose||6.55|0.837|= 0.011
91555927|NCT05485805|182999887|OTHER||Geometric LS means|16.504|||<|0.001|TWO_SIDED|95.0|12.49|20.517|||ANCOVA|||0-12 hours post-dose||20.517|12.49|< 0.001
91555928|NCT05485805|182999887|OTHER||Geometric LS means|-3.437|||=|0.173|TWO_SIDED|95.0|-8.389|1.515|||ANCOVA|||0-12 hours post-dose||1.515|-8.389|= 0.173
91555929|NCT05485805|182999887|OTHER||Geometric LS means|0.744|||=|0.61|TWO_SIDED|95.0|-2.119|3.608|||ANCOVA|||0-12 hours post-dose||3.608|-2.119|= 0.61
91555930|NCT05485805|182999887|OTHER||Geometric LS means|20.197|||<|0.001|TWO_SIDED|95.0|16.189|24.206|||ANCOVA|||0-12 hours post-dose||24.206|16.189|< 0.001
91555931|NCT05485805|182999887|OTHER||Geometric LS means|13.067|||<|0.001|TWO_SIDED|95.0|8.992|17.143|||ANCOVA|||0-12 hours post-dose||17.143|8.992|< 0.001
91555932|NCT05485805|182999887|OTHER||Geometric LS means|17.248|||<|0.001|TWO_SIDED|95.0|13.236|21.261|||ANCOVA|||0-12 hours post-dose||21.261|13.236|< 0.001
91555933|NCT05485805|182999887|OTHER||Geometric LS means|16.761|||<|0.001|TWO_SIDED|95.0|12.69|20.831|||ANCOVA|||0-12 hours post-dose||20.831|12.69|< 0.001
91555934|NCT05485805|182999887|OTHER||Geometric LS means|13.812|||<|0.001|TWO_SIDED|95.0|9.738|17.886|||ANCOVA|||0-12 hours post-dose||17.886|9.738|< 0.001
91555935|NCT05485805|182999887|OTHER||Geometric LS means|-2.312|||=|0.473|TWO_SIDED|95.0|-8.635|4.011|||ANCOVA|||0-24 hours post-dose||4.011|-8.635|= 0.473
91768215|NCT00762359|183425375|SUPERIORITY_OR_OTHER|||||||0.8678||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8678
91555936|NCT05485805|182999887|OTHER||Geometric LS means|27.08|||<|0.001|TWO_SIDED|95.0|18.188|35.973|||ANCOVA|||0-24 hours post-dose||35.973|18.188|< 0.001
91768216|NCT00762359|183425376|SUPERIORITY_OR_OTHER|||||||0.2688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2688
91555937|NCT05485805|182999887|OTHER||Geometric LS means|-6.928|||=|0.215|TWO_SIDED|95.0|-17.9|4.044|||ANCOVA|||0-24 hours post-dose||4.044|-17.9|= 0.215
91555938|NCT05485805|182999887|OTHER||Geometric LS means|2.468|||=|0.445|TWO_SIDED|95.0|-3.876|8.813|||ANCOVA|||0-24 hours post-dose||8.813|-3.876|= 0.445
91555939|NCT05485805|182999887|OTHER||Geometric LS means|20.152|||<|0.001|TWO_SIDED|95.0|11.122|29.183|||ANCOVA|||0-24 hours post-dose||29.183|11.122|< 0.001
91555940|NCT05485805|182999887|OTHER||Geometric LS means|24.933|||<|0.001|TWO_SIDED|95.0|15.914|33.952|||ANCOVA|||0-24 hours post-dose||33.952|15.914|< 0.001
91555941|NCT05485805|182999887|OTHER||Geometric LS means|22.621|||<|0.001|TWO_SIDED|95.0|13.594|31.648|||ANCOVA|||0-24 hours post-dose||31.648|13.594|< 0.001
91555942|NCT05485805|182999888|OTHER||||||=|0.963|||||||ANCOVA|||||||= 0.963
91555943|NCT05485805|182999888|OTHER||||||=|0.118|||||||ANCOVA|||||||= 0.118
91555944|NCT05485805|182999888|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555945|NCT05485805|182999888|OTHER||||||=|0.244|||||||ANCOVA|||||||= 0.244
91555946|NCT05485805|182999888|OTHER||||||=|0.139|||||||ANCOVA|||||||= 0.139
91555947|NCT05485805|182999888|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555948|NCT05485805|182999888|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555949|NCT05485805|182999888|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555950|NCT05485805|182999888|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555951|NCT05485805|182999888|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555952|NCT05485805|182999890|OTHER||||||=|0.647|||||||ANCOVA|||||||= 0.647
91555953|NCT05485805|182999890|OTHER||||||=|0.714|||||||ANCOVA|||||||= 0.714
91555954|NCT05485805|182999890|OTHER||||||=|0.065|||||||ANCOVA|||||||= 0.065
91555955|NCT05485805|182999890|OTHER||||||=|0.742|||||||ANCOVA|||||||= 0.742
91555956|NCT05485805|182999890|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555957|NCT05485805|182999890|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555958|NCT05485805|182999890|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555959|NCT05485805|182999890|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555960|NCT05485805|182999890|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555961|NCT05485805|182999891|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
91555962|NCT05485805|182999891|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
91555963|NCT05485805|182999891|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555964|NCT05485805|182999891|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
91555965|NCT05485805|182999891|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555966|NCT05485805|182999891|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555967|NCT05485805|182999891|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555968|NCT05485805|182999891|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555969|NCT05485805|182999891|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555970|NCT05485805|182999892|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
91555971|NCT05485805|182999892|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
91555972|NCT05485805|182999892|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555973|NCT05485805|182999892|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
91555974|NCT05485805|182999892|OTHER||||||=|0.772|||||||ANCOVA|||||||= 0.772
91555975|NCT05485805|182999892|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555976|NCT05485805|182999892|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555977|NCT05485805|182999892|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555978|NCT05485805|182999892|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91555979|NCT05485805|182999892|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91768217|NCT00762359|183425378|SUPERIORITY_OR_OTHER|||||||0.7054||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7054
91768218|NCT00762359|183425379|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3400
91768219|NCT00762359|183425380|SUPERIORITY_OR_OTHER|||||||0.8813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8813
91768220|NCT00762359|183425381|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1862
91768221|NCT00762359|183425383|SUPERIORITY_OR_OTHER|||||||0.8604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8604
91768222|NCT00762359|183425384|SUPERIORITY_OR_OTHER|||||||0.5485||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5485
91768223|NCT00762359|183425385|SUPERIORITY_OR_OTHER|||||||0.7382||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7382
91555980|NCT05485805|182999895|OTHER||geometric LS mean square|-0.14|||=|0.334|TWO_SIDED|95.0|-0.44|0.15|||ANCOVA|||||0.15|-0.44|= 0.334
91555981|NCT05485805|182999895|OTHER||geometric LS mean square|0.04|||=|0.783|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||||0.33|-0.25|= 0.783
91555982|NCT05485805|182999895|OTHER||geometric LS mean square|-0.08|||=|0.687|TWO_SIDED|95.0|-0.5|0.33|||ANCOVA|||||0.33|-0.5|= 0.687
91555983|NCT05485805|182999895|OTHER||geometric LS mean square|-0.02|||=|0.927|TWO_SIDED|95.0|-0.53|0.49|||ANCOVA|||||0.49|-0.53|= 0.927
91555984|NCT05485805|182999895|OTHER||geometric LS mean square|-0.1|||=|0.492|TWO_SIDED|95.0|-0.4|0.19|||ANCOVA|||||0.19|-0.4|= 0.492
91555985|NCT05485805|182999895|OTHER||geometric LS mean square|-0.04|||=|0.836|TWO_SIDED|95.0|-0.46|0.37|||ANCOVA|||||0.37|-0.46|= 0.836
91555986|NCT05485805|182999895|OTHER||geometric LS mean square|-0.11|||=|0.611|TWO_SIDED|95.0|-0.53|0.31|||ANCOVA|||||0.31|-0.53|= 0.611
91555987|NCT05485805|182999895|OTHER||geometric LS mean square|-0.19|||=|0.371|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||||0.22|-0.6|= 0.371
91555988|NCT05485805|182999895|OTHER||geometric LS mean square|-0.07|||=|0.752|TWO_SIDED|95.0|-0.49|0.35|||ANCOVA|||||0.35|-0.49|= 0.752
91555989|NCT05485805|182999895|OTHER||geometric LS mean square|-0.21|||=|0.321|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|= 0.321
91555990|NCT04218357|182999903|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||GEE|Generalized Estimating Equation with standard errors, and an unstructured correlation matrix with medication and time as within-subject factors.||All outcomes were assessed in real-time in the laboratory testing probenecid compared to placebo condition during the alcohol administration procedure.||||0.05
91555991|NCT05048394|182999951|EQUIVALENCE|Equivalence is defined as a difference of 0.|||||<|0.001||||||Threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
91555992|NCT05048394|182999952|EQUIVALENCE|Equivalence is defined as a difference of 0.||||||0.14||||||Threshold for significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.14
91555993|NCT05037513|182999956|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
91555994|NCT05037513|182999957|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
91555995|NCT06140290|182999994|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|108.32|||||TWO_SIDED|90.0|101.2|115.94|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||115.94|101.20|
91768224|NCT00762359|183425386|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7619
91768225|NCT00762359|183425388|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0204
91768226|NCT00762359|183425389|SUPERIORITY_OR_OTHER|||||||0.0046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0046
91768227|NCT00762359|183425390|SUPERIORITY_OR_OTHER|||||||0.0059||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0059
91768228|NCT00762359|183425391|SUPERIORITY_OR_OTHER|||||||0.1229||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1229
91768229|NCT00762359|183425393|SUPERIORITY_OR_OTHER|||||||0.2694||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2694
91768230|NCT00762359|183425394|SUPERIORITY_OR_OTHER|||||||0.0141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0141
91768231|NCT00762359|183425395|SUPERIORITY_OR_OTHER|||||||0.3128||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3128
91768232|NCT00762359|183425396|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1450
91768233|NCT00762359|183425398|SUPERIORITY_OR_OTHER|||||||0.6175||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6175
91768234|NCT00762359|183425399|SUPERIORITY_OR_OTHER|||||||0.4496||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4496
91768235|NCT00762359|183425400|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4718
91768236|NCT00762359|183425401|SUPERIORITY_OR_OTHER|||||||0.4484||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4484
91768237|NCT00762359|183425403|SUPERIORITY_OR_OTHER|||||||0.2604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2604
91768238|NCT00762359|183425404|SUPERIORITY_OR_OTHER|||||||0.6818||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6818
91768239|NCT00762359|183425405|SUPERIORITY_OR_OTHER|||||||0.9015||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9015
91768240|NCT00762359|183425406|SUPERIORITY_OR_OTHER|||||||0.4497||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4497
91768241|NCT04233008|183425433|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91768242|NCT04233008|183425434|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
91768243|NCT04233008|183425435|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91768244|NCT04233008|183425436|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91768245|NCT04233008|183425437|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
91768246|NCT04233008|183425439|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
91768247|NCT00416624|183425445|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.41|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.41
91768248|NCT00416624|183425447|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.|||||>|0.13|TWO_SIDED||||||Fisher Exact|||||||>0.13
91555996|NCT06140290|182999995|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|120.41|||||TWO_SIDED|90.0|108.02|134.22|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||134.22|108.02|
91555997|NCT06140290|182999996|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|115.29|||||TWO_SIDED|90.0|105.17|126.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||126.38|105.17|
91555998|NCT06140290|182999997|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|106.75|||||TWO_SIDED|90.0|99.33|114.73|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||114.73|99.33|
91555999|NCT06140290|182999998|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|91.8|||||TWO_SIDED|90.0|77.76|108.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA (Analysis of variance) model with treatment as a fixed effect.||108.38|77.76|
91768249|NCT00416624|183425449|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.49|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.49
91768250|NCT00416624|183425452|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.|||||>|0.56|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.||||>0.56
91768251|NCT01173016|183425476|OTHER|||||||0.038|||||||Regression, Logistic|||Impact of anti-laronidase antibody status on the change in 6MWT outcome was tested||||0.038
91768252|NCT04245111|183425484|OTHER|No other statistical analysis completed other than percentage of patients completed as reported in the data table section||||||||||||||||No other statistical analysis completed other than percentage of patients completed as reported in the data table section|No other statistical analysis completed other than percentage of patients completed as reported in the data table section|||
91556000|NCT06140290|182999998|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|86.33|122.19|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||122.19|86.33|
91768253|NCT02792231|183425508|SUPERIORITY||rate ratio|0.416|||<|0.001|TWO_SIDED|95.0|0.309|0.56|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.560|0.309|<0.001
91768254|NCT02792231|183425509|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||Pooled data - this study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.863|0.500|0.003
91768255|NCT02792231|183425510|SUPERIORITY||Hazard Ratio (HR)|0.662||||0.038|TWO_SIDED|95.0|0.449|0.977|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.977|0.449|0.038
91768256|NCT02792231|183425511|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.917|0.498|0.012
91768257|NCT02792231|183425512|SUPERIORITY||Hazard Ratio (HR)|0.759||||0.215|TWO_SIDED|95.0|0.49|1.174|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.174|0.490|0.215
91768258|NCT02792231|183425513|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.928|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.928|0.952|0.092
91556001|NCT06140290|182999999|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|86.34|||||TWO_SIDED|90.0|69.42|107.37|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.37|69.42|
91556002|NCT06140290|182999999|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.98|||||TWO_SIDED|90.0|76.99|124.7|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.70|76.99|
91556003|NCT06140290|183000000|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|88.72|||||TWO_SIDED|90.0|73.1|107.68|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.68|73.10|
91556004|NCT06140290|183000000|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.54|||||TWO_SIDED|90.0|78.74|120.83|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||120.83|78.74|
91556005|NCT06140290|183000001|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|94.14|||||TWO_SIDED|90.0|79.01|112.17|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||112.17|79.01|
91556006|NCT06140290|183000001|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|103.36|||||TWO_SIDED|90.0|86.04|124.16|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.16|86.04|
91556007|NCT02232737|183000016|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
91556008|NCT02232737|183000016|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
91556009|NCT03849937|183000017|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91556010|NCT03849937|183000017|SUPERIORITY|||||||0.091||||||Time 1 to Time 2|t-test, 2 sided|||||||.091
91556011|NCT03849937|183000017|SUPERIORITY||||||<|0.001||||||Time 2 to Time 3|t-test, 2 sided|||||||<.001
91556012|NCT03849937|183000018|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Effective Communication||||<.001
91768259|NCT02792231|183425514|SUPERIORITY||Hazard Ratio (HR)|1.523||||0.09|TWO_SIDED|95.0|0.936|2.477|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||2.477|0.936|0.090
91768260|NCT02792231|183425515|SUPERIORITY||rate ratio|0.061|||<|0.001|TWO_SIDED|95.0|0.037|0.101|||negative binomial regression model|||||0.101|0.037|<.001
91556013|NCT03849937|183000018|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Appropriate Communication||||<.001
91556014|NCT03849937|183000018|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes elderspeak||||<.001
91556015|NCT03849937|183000018|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes person-centered communication||||<.001
91768261|NCT02792231|183425516|SUPERIORITY||rate ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.17|0.27|||negative binomial regression model|||Month 12||0.27|0.17|<.001
91768262|NCT02792231|183425516|SUPERIORITY||rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.31|||negative binomial regression model|||Month 24||0.31|0.12|<.001
91768263|NCT02792231|183425516|SUPERIORITY||rate ratio|0.15|||<|0.001|TWO_SIDED|95.0|0.13|0.19|||negative binomial regression model|||End of Study||0.19|0.13|<.001
91556016|NCT00705406|183000069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.222|TWO_SIDED|95.0|0.723|1.188|||Wilcoxon-Gehan test statistic|P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.|||1.188|0.723|0.222
91556017|NCT00705406|183000070|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||van Elteren test|P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.||||||>0.05
91556018|NCT00705406|183000071|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||van Elteren test|P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.||||||0.421
91556019|NCT00705406|183000072|SUPERIORITY_OR_OTHER|||||||0.885|TWO_SIDED||||||Wilcoxon-Gehan test statistic|P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.||||||0.885
91556020|NCT00705406|183000073|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.||||||0.306
91556021|NCT04732000|183000094|OTHER||Median Difference (Final Values)|-0.1373||||0.549|TWO_SIDED|||||The a priori threshold for statistical significance is \< 0.05.|Mann Whitney test, 2-sided|||||||0.5490
91556022|NCT00683800|183000099|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.89|||<|0.001|TWO_SIDED|95.0|-3.8|-1.98|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.98|-3.80|<0.001
91556023|NCT00683800|183000100|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79|||<|0.001|TWO_SIDED|95.0|-3.77|-1.82|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.82|-3.77|<0.001
91556024|NCT00683800|183000101|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.4|-0.16|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.16|-0.40|<0.001
91556025|NCT00683800|183000102|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.18|-0.44|<0.001
91556026|NCT00683800|183000103|SUPERIORITY_OR_OTHER||Wald Formula|-1.07|||||TWO_SIDED|90.0|-2.86|0.72|||||The 90% CI for excess risk was obtained using the Wald Formula.|Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||0.72|-2.86|
91768264|NCT02792231|183425517|SUPERIORITY||Geo-mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.85|0.93|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.93|0.85|<.001
91768265|NCT02792231|183425517|SUPERIORITY||Geo-mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.7|0.79|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.79|0.70|<.001
91768266|NCT02792231|183425517|SUPERIORITY||Geo-mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.71|0.81|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.81|0.71|<.001
91768267|NCT02792231|183425518|SUPERIORITY||Mean Difference (Net)|0.07||||0.128|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.128
91556027|NCT00683800|183000104|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.||||<0.001
91556028|NCT00683800|183000105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.47|||<|0.001|TWO_SIDED|95.0|2.24|5.36|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.36|2.24|<0.001
91556029|NCT00683800|183000105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.1|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||4.10|1.75|<0.001
91556030|NCT00683800|183000106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.47|7.81|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||7.81|2.47|<0.001
91556031|NCT00683800|183000106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.96|5.09|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.09|1.96|<0.001
91768268|NCT02792231|183425521|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.847|0.486|0.002
91768269|NCT02792231|183425522|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.898|0.481|0.008
91768270|NCT00558246|183425549|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|Differences in proportion of successes|0.0||||1|TWO_SIDED|95.0|-5.9|5.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||5.9|-5.9|1.0000
91768271|NCT00558246|183425550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91768272|NCT00558246|183425551|SUPERIORITY_OR_OTHER|||||||1||95.0|||||McNemar|||||||1.0000
91556032|NCT00683800|183000107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||A log-rank test was used to compare the treatment groups.||||<0.001
91556033|NCT00683800|183000108|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-3.07|-1.0|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-1.00|-3.07|<0.001
91556034|NCT00683800|183000108|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.81|||<|0.001|TWO_SIDED|95.0|-4.12|-1.51|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-1.51|-4.12|<0.001
91556035|NCT00683800|183000109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31||||0.002|TWO_SIDED|95.0|-0.51|-0.12|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-0.12|-0.51|0.002
91556036|NCT00683800|183000109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.54|-0.11|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-0.11|-0.54|0.003
91556037|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.05|-1.64|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.64|-3.05|<0.001
91556038|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.51|-0.99|<0.001
91556039|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.45|-0.89|<0.001
91556040|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05||||0.162|TWO_SIDED|95.0|-0.13|0.02|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.02|-0.13|0.162
91556041|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.84|-1.0|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-1.84|<0.001
91556042|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22||||0.066|TWO_SIDED|95.0|-0.46|0.01|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.46|0.066
91768273|NCT00558246|183425552|SUPERIORITY_OR_OTHER|||||||0.2266|||||||McNemar|||||||0.2266
91768274|NCT00558246|183425553|SUPERIORITY_OR_OTHER|||||||0.5078||0.0|||||McNemar|||||||0.5078
91768275|NCT00861705|183425566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0018
91768276|NCT00861705|183425567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0089
91768277|NCT00861705|183425568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.0029
91768278|NCT00861705|183425569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.057
91768279|NCT00861705|183425573|SUPERIORITY||Cox Proportional Hazard|1.19|||||TWO_SIDED|95.0|0.67|2.1||||||||2.10|0.67|
91768280|NCT00861705|183425573|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.82|2.47||||||||2.47|0.82|
91768281|NCT00861705|183425573|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
91768282|NCT00861705|183425574|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.66|1.75||||||||1.75|0.66|
91768283|NCT00861705|183425574|SUPERIORITY||Cox Proportional Hazard|1.2|||||TWO_SIDED|95.0|0.74|1.92||||||||1.92|0.74|
91768284|NCT00861705|183425574|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
91768285|NCT00861705|183425575|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.66|2.03||||||||2.03|0.66|
91768286|NCT00861705|183425575|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.16||||||||2.16|0.72|
91768287|NCT00861705|183425575|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.53|1.7||||||||1.70|0.53|
91556043|NCT00683800|183000110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.79|-0.5|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.50|-0.79|<0.001
91556044|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.87|||<|0.001|TWO_SIDED|95.0|-2.57|-1.18|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.18|-2.57|<0.001
91556045|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.9|-0.41|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.41|-0.90|<0.001
91556046|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.37|-0.80|<0.001
91556047|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04||||0.282|TWO_SIDED|95.0|-0.13|0.04|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.04|-0.13|0.282
91556048|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.66|-0.82|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.82|-1.66|<0.001
91556049|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17||||0.14|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.06|-0.41|0.140
91556050|NCT00683800|183000111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.26|-0.56|<0.001
91556051|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.71|||<|0.001|TWO_SIDED|95.0|-2.42|-1.0|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-2.42|<0.001
91556052|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.81|-0.3|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.30|-0.81|<0.001
91768288|NCT04864249|183425593|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
91556053|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.83|-0.4|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.40|-0.83|<0.001
91768289|NCT04864249|183425594|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
91768290|NCT04864249|183425595|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
91768291|NCT04864249|183425596|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91768292|NCT04864249|183425597|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
91768293|NCT04864249|183425598|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
91768294|NCT04864249|183425599|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
91768295|NCT04864249|183425600|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
91768296|NCT04864249|183425601|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91768297|NCT04864249|183425602|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
91768298|NCT04864249|183425603|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
91768299|NCT04864249|183425604|SUPERIORITY|||||||0.66|||||||Chi-squared|||||||0.66
91556054|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08||||0.082|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.17|0.082
91556055|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.61|-0.75|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.75|-1.61|<0.001
91556056|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02||||0.865|TWO_SIDED|95.0|-0.25|0.21|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.21|-0.25|0.865
91556057|NCT00683800|183000112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.61|-0.29|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.29|-0.61|<0.001
91556058|NCT00683800|183000113|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556059|NCT00683800|183000114|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556060|NCT00683800|183000115|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556061|NCT00683800|183000116|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91768300|NCT04864249|183425605|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91556062|NCT00683800|183000117|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556063|NCT00683800|183000118|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556064|NCT00683800|183000119|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91768301|NCT04864249|183425606|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
91556065|NCT00683800|183000120|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556066|NCT00683800|183000121|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556067|NCT00683800|183000122|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556068|NCT00683800|183000123|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556069|NCT00683800|183000124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
91556070|NCT00683800|183000125|SUPERIORITY_OR_OTHER||Wald Formula|1.11|||||TWO_SIDED|90.0|-0.68|2.9|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||2.9|-0.68|
91556071|NCT00683800|183000127|SUPERIORITY_OR_OTHER||Wald Formula|2.31|||||TWO_SIDED|90.0|-2.08|6.71|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||6.71|-2.08|
91768302|NCT04864249|183425607|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
91768303|NCT04864249|183425608|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
91768304|NCT04864249|183425609|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
91768305|NCT04864249|183425610|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
91768306|NCT04864249|183425611|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
91768307|NCT04864249|183425612|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91768308|NCT04864249|183425613|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
91768309|NCT04864249|183425614|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
91768310|NCT04864249|183425615|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
91556072|NCT00683800|183000128|SUPERIORITY_OR_OTHER||Wald Formula|0.08|||||TWO_SIDED|90.0|-3.51|3.67|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||3.67|-3.51|
91556073|NCT03509909|183000205|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
91556074|NCT03683576|183000213|SUPERIORITY||Odds Ratio (OR)|0.674||||0.1425|TWO_SIDED|95.0|0.398|1.142|||Regression, Logistic||GB001 20 mg vs. Placebo|||1.142|0.398|0.1425
91556075|NCT03683576|183000213|SUPERIORITY||Odds Ratio (OR)|0.677||||0.1482|TWO_SIDED|95.0|0.399|1.149|||Regression, Logistic||GB001 40 mg vs. Placebo|||1.149|0.399|0.1482
91556076|NCT03683576|183000213|SUPERIORITY||Odds Ratio (OR)|0.651||||0.1086|TWO_SIDED|95.0|0.385|1.1|||Regression, Logistic||GB001 60 mg vs. Placebo|||1.100|0.385|0.1086
91556077|NCT03683576|183000214|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1647|TWO_SIDED|95.0|-0.36|0.06|||ANCOVA||GB001 20 mg vs. Placebo|||0.06|-0.36|0.1647
91556078|NCT03683576|183000214|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1737|TWO_SIDED|95.0|-0.37|0.07|||ANCOVA||GB001 40 mg vs. Placebo|||0.07|-0.37|0.1737
91556079|NCT03683576|183000214|SUPERIORITY||Mean Difference (Net)|-0.19||||0.0879|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA||GB001 60 mg vs. Placebo|||0.03|-0.40|0.0879
91556080|NCT03683576|183000215|SUPERIORITY||Mean Difference (Net)|0.016||||0.7718|TWO_SIDED|95.0|-0.091|0.123|||ANCOVA||GB001 20 mg vs. Placebo|||0.123|-0.091|0.7718
91556081|NCT03683576|183000215|SUPERIORITY||Mean Difference (Net)|0.041||||0.4562|TWO_SIDED|95.0|-0.067|0.149|||ANCOVA||GB001 40 mg vs. Placebo|||0.149|-0.067|0.4562
91556082|NCT03683576|183000215|SUPERIORITY||Mean Difference (Net)|0.075||||0.1631|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||GB001 60 mg vs. Placebo|||0.180|-0.030|0.1631
91768311|NCT04864249|183425616|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
91768312|NCT04864249|183425617|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91556083|NCT03683576|183000216|SUPERIORITY||Hazard Ratio (HR)|0.719||||0.0466|TWO_SIDED|95.0|0.519|0.995|||Regression, Cox||GB001 20 mg vs. Placebo|||0.995|0.519|0.0466
91556084|NCT03683576|183000216|SUPERIORITY||Hazard Ratio (HR)|0.773||||0.1222|TWO_SIDED|95.0|0.558|1.071|||Regression, Cox||GB001 40 mg vs. Placebo|||1.071|0.558|0.1222
91556085|NCT03683576|183000216|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0304|TWO_SIDED|95.0|0.505|0.967|||Regression, Cox||GB001 60 mg vs. Placebo|||0.967|0.505|0.0304
91556086|NCT03683576|183000217|SUPERIORITY||Rate ratio|0.797||||0.3382|TWO_SIDED|95.0|0.501|1.268|||Negative binomial regression model||GB001 20 mg vs. Placebo|||1.268|0.501|0.3382
91556087|NCT03683576|183000217|SUPERIORITY||Rate ratio|0.748||||0.2248|TWO_SIDED|95.0|0.469|1.195|||Negative binomial regression model||GB001 40 mg vs. Placebo|||1.195|0.469|0.2248
91556088|NCT03683576|183000217|SUPERIORITY||Rate ratio|0.889||||0.609|TWO_SIDED|95.0|0.565|1.397|||Negative binomial regression model||GB001 60 mg vs. Placebo|||1.397|0.565|0.6090
91556089|NCT03683576|183000218|SUPERIORITY||Mean Difference (Net)|-0.023||||0.6645|TWO_SIDED|95.0|-0.127|0.081|||ANCOVA||GB001 20 mg vs. Placebo|||0.081|-0.127|0.6645
91556090|NCT03683576|183000218|SUPERIORITY||Mean Difference (Net)|0.035||||0.5288|TWO_SIDED|95.0|-0.074|0.144|||ANCOVA||GB001 40 mg vs. Placebo|||0.144|-0.074|0.5288
91556091|NCT03683576|183000218|SUPERIORITY||Mean Difference (Net)|0.079||||0.1362|TWO_SIDED|95.0|-0.025|0.182|||ANCOVA||GB001 60 mg vs. Placebo|||0.182|-0.025|0.1362
91556092|NCT03683576|183000219|SUPERIORITY||Mean Difference (Net)|6.122||||0.3957|TWO_SIDED|95.0|-8.007|20.251|||ANCOVA||GB001 20 mg vs. Placebo|||20.251|-8.007|0.3957
91556093|NCT03683576|183000219|SUPERIORITY||Mean Difference (Net)|13.948||||0.0598|TWO_SIDED|95.0|-0.578|28.474|||ANCOVA||GB001 40 mg vs. Placebo|||28.474|-0.578|0.0598
91556094|NCT03683576|183000219|SUPERIORITY||Mean Difference (Net)|5.588||||0.4376|TWO_SIDED|95.0|-8.522|19.698|||ANCOVA||GB001 60 mg vs. Placebo|||19.698|-8.522|0.4376
91556095|NCT02350634|183000229|OTHER||Correlation coefficient|0.429|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
91556096|NCT02350634|183000230|OTHER||Correlation coefficient|0.681|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
91556097|NCT02350634|183000231|OTHER||Correlation coefficient|0.644||||0.00278|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.00278
91556098|NCT02350634|183000232|OTHER||Correlation coefficient|0.437||||0.12|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.12
91556099|NCT02350634|183000233|OTHER||Correlation coefficient|0.324||||0.0712|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0712
91768313|NCT04864249|183425618|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
91768314|NCT04864249|183425619|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91768315|NCT04864249|183425620|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91768316|NCT04864249|183425621|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
91768317|NCT04864249|183425622|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91768318|NCT04864249|183425623|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
91768319|NCT04864249|183425624|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
91768320|NCT04864249|183425625|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
91768321|NCT04864249|183425626|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
91768322|NCT04864249|183425627|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91556100|NCT02350634|183000234|OTHER||Correlation coefficient|0.564||||0.0958|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0958
91556101|NCT02350634|183000235|OTHER||Correlation coefficient|-0.189||||0.558|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.558
91556102|NCT04241848|183000241|SUPERIORITY||||||=|0.007|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.007
91556103|NCT04241848|183000241|SUPERIORITY||||||=|0.24|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.240
91556104|NCT04241848|183000241|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.04
91768323|NCT04864249|183425628|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91768324|NCT04678115|183425643|OTHER|Power Calculation: Sample size was estimated based on the treatment condition (three-level factor) effect size on the spontaneous blink IPF measurements (0.55) after eight participants had completed the crossover using one-way analysis of variance power calculation. This led to a sample size of 12 participants with power of 0.80 and type II error of alpha 0.05. To account for possible attrition, 16 were enrolled, with 15 completing the crossover.|||||<|0.001||||||a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Linear mixed-effects regression was used to determine the effect of treatment condition on the spontaneous blink and resting state open IPF, with participant as random intercept. Covariates of age, gender, blink sequence, and crossover order were investigated alone, and significant (P \< 0.05) covariates were included in the final model, from which the estimated marginal means and their 95% confidence interval were reported. Hypothesis: MLP allows a more complete spontaneous blink.||||<0.001
91768325|NCT04678115|183425644|OTHER|||||||0.001|||||||Mixed Models Analysis|||Hypothesis was that both devices (MLP and KFTS) would open the eye equally well, and that both would be better than sham treatment.||||0.001
91556105|NCT04241848|183000244|SUPERIORITY|||||||0.129|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.129
91556106|NCT04241848|183000244|SUPERIORITY|||||||0.25|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.250
91556107|NCT04241848|183000244|SUPERIORITY||||||=|0.073|||||||t-test, 2 sided|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.073
91556108|NCT04241848|183000245|SUPERIORITY||||||=|0.091|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.091
91556109|NCT04241848|183000245|SUPERIORITY|||||||0.296|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.296
91556110|NCT04241848|183000245|SUPERIORITY|||||||0.427|||||||t-test, 2 sided|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.427
91556111|NCT04241848|183000246|SUPERIORITY|||||||0.063|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.063
91556112|NCT04241848|183000246|SUPERIORITY|||||||0.447|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.447
91556113|NCT04241848|183000246|SUPERIORITY|||||||0.096|||||||t-test, 2 sided|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.096
91556114|NCT04241848|183000247|SUPERIORITY|||||||0.035|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.035
91556115|NCT04241848|183000247|SUPERIORITY||||||=|0.677|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.677
91556116|NCT04241848|183000247|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.022
91556117|NCT04241848|183000248|SUPERIORITY||||||=|0.098|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.098
91768326|NCT04678115|183425645|OTHER|||||||0.001|||||||test of proportionality|||A test of proportionality was performed to determine the effect of the three treatments on the probability of the eyelid not fully closing.||||0.001
91768327|NCT02552966|183425659|OTHER|||||||0.61|||||||t-test, 2 sided|This t-test was applied to determine if the mean salivary pepsin concentration changed between baseline and 2 week post UESAD measurements.||||||0.61
91768328|NCT02552966|183425660|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91768329|NCT02552966|183425661|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91768330|NCT02552966|183425662|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91768331|NCT03483896|183425685|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
91556118|NCT04241848|183000248|SUPERIORITY|||||||0.666|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.666
91768332|NCT03483896|183425686|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
91768333|NCT02365649|183425687|SUPERIORITY||Adjusted risk difference from placebo|9.9||||0.056|TWO_SIDED|95.0|-0.3|20.1||Statistical significance was prespecified at α = 0.1. Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.1|-0.3|0.056
91768334|NCT02365649|183425687|SUPERIORITY||Adjusted risk difference from placebo|7.4||||0.108|TWO_SIDED|95.0|-1.6|16.4||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.4|-1.6|0.108
91768335|NCT02365649|183425687|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
91768336|NCT02365649|183425687|SUPERIORITY||Adjusted risk difference from placebo|21.0||||0.004|TWO_SIDED|95.0|6.8|35.2||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.2|6.8|0.004
91768337|NCT02365649|183425687|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.025|TWO_SIDED|95.0|1.8|25.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.5|1.8|0.025
91556119|NCT04241848|183000248|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.007
91556120|NCT04241848|183000249|SUPERIORITY||||||=|0.001|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.001
91556121|NCT04241848|183000249|SUPERIORITY||||||=|0.009|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.009
91556122|NCT04241848|183000249|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.018
91556123|NCT02823028|183000304|SUPERIORITY||Odds Ratio (OR)|0.931||||0.779|TWO_SIDED||||||Chi-squared|||||||.779
91768338|NCT02365649|183425688|SUPERIORITY||Adjusted risk difference from placebo|2.5||||0.74|TWO_SIDED|95.0|-12.3|17.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||17.3|-12.3|0.74
91768339|NCT02365649|183425688|SUPERIORITY||Adjusted risk difference from placebo|16.2||||0.082|TWO_SIDED|95.0|-2.0|34.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.3|-2.0|0.082
91556124|NCT03414684|183000334|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.88|TWO_SIDED|95.0|0.49|1.84|||Log Rank|stratified log rank test|Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A|||1.84|0.49|0.88
91556125|NCT03414684|183000335|SUPERIORITY||Odds Ratio (OR)|1.09||||1|TWO_SIDED|95.0|0.29|4.18|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A|||4.18|0.29|1
91768340|NCT02365649|183425688|SUPERIORITY||Adjusted risk difference from placebo|0.5||||0.952|TWO_SIDED|95.0|-14.1|15.0||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.0|-14.1|0.952
91556126|NCT03414684|183000337|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.49|TWO_SIDED|95.0|0.43|1.5|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.50|0.43|0.49
91556127|NCT03414684|183000338|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.32|3.43|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||3.43|0.32|1
91556128|NCT03414684|183000339|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.36|TWO_SIDED|95.0|0.13|2.12|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.12|0.13|0.36
91556129|NCT03414684|183000340|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.68|TWO_SIDED|95.0|0.43|3.43|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.43|0.43|0.68
91556130|NCT03414684|183000341|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.27|TWO_SIDED|95.0|0.18|1.62|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.62|0.18|0.27
91556131|NCT03414684|183000342|SUPERIORITY||Odds Ratio (OR)|0.81||||1|TWO_SIDED|95.0|0.08|7.78|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||7.78|0.08|1
91556132|NCT03414684|183000344|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.61|TWO_SIDED|95.0|0.26|2.16|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.16|0.26|0.61
91556133|NCT03414684|183000345|SUPERIORITY||Odds Ratio (OR)|0.79||||1|TWO_SIDED|95.0|0.1|5.93|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||5.93|0.10|1
91556134|NCT03414684|183000347|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.73|TWO_SIDED|95.0|0.14|3.89|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.89|0.14|0.73
91556135|NCT04038580|183000362|SUPERIORITY|||||||0.553||||||Statistical significance was set a-priori at p\<0.05|ANOVA|||The null hypothesis was that all sockets would have the same SCS||||0.553
91556136|NCT04038580|183000363|SUPERIORITY|Frustration sub-scale||||||0.536|||||||ANOVA|||The null hypothesis was that all sockets would be the same||||0.536
91556137|NCT04038580|183000363|SUPERIORITY|Perceived Response||||||0.598|||||||ANOVA|||||||0.598
91556138|NCT04038580|183000363|SUPERIORITY|Social Burden||||||0.072|||||||ANOVA|||||||0.072
91556139|NCT04038580|183000363|SUPERIORITY|Ambulation Sub-scale||||||0.018|||||||ANOVA|||||||0.018
91556140|NCT04038580|183000363|SUPERIORITY|Prosthesis Utility||||||0.037|||||||ANOVA|||||||0.037
91556141|NCT04038580|183000363|SUPERIORITY|Residual Limb Health||||||0.254|||||||ANOVA|||||||0.254
91556142|NCT04038580|183000363|SUPERIORITY|Appearance||||||0.032|||||||ANOVA|||||||0.032
91556143|NCT04038580|183000363|SUPERIORITY|Sounds||||||0.352|||||||ANOVA|||||||0.352
91556144|NCT04038580|183000363|SUPERIORITY|Well-being||||||0.077|||||||ANOVA|||||||.077
91768341|NCT02365649|183425688|SUPERIORITY||Adjusted risk difference from placebo|11.2||||0.205|TWO_SIDED|95.0|-6.1|28.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.5|-6.1|0.205
91768342|NCT02365649|183425688|SUPERIORITY||Adjusted risk difference from placebo|4.1||||0.607|TWO_SIDED|95.0|-11.5|19.6||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||19.6|-11.5|0.607
91556145|NCT04038580|183000364|SUPERIORITY|||||||0.95|||||||ANOVA|general linear model with socket as fixed factor and participant as random factor||||||0.95
91556146|NCT04038580|183000365|SUPERIORITY|||||||0.853|||||||ANOVA|general linear model with sockets as fixed effect and subjects as random effect||||||.853
91556147|NCT04038580|183000366|SUPERIORITY|||||||0.565|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||0.565
91556148|NCT04038580|183000368|SUPERIORITY|||||||0.374|||||||ANOVA|general linear model with socket as fixed factor and subjects as random factor||||||.374
91556149|NCT04038580|183000370|SUPERIORITY|||||||0.574|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||.574
91556150|NCT00975585|183000442|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.46|-0.058|0.031|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.||0.031|-0.058|
91556151|NCT00975585|183000443|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.25|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|97.46|-0.021|-0.01|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.||-0.010|-0.021|
91556152|NCT00975585|183000444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|97.46|0.117|0.402|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.||0.402|0.117|
91556153|NCT00975585|183000445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|97.46|-0.218|0.098|||Mixed Models Analysis||The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.||0.098|-0.218|
91556154|NCT00975585|183000446|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|98.2|-0.123|-0.051|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.||-0.051|-0.123|
91556155|NCT00975585|183000447|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|98.2|-0.068|0.008|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.||0.008|-0.068|
91556156|NCT00975585|183000448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.411|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|98.2|-0.411|-0.117|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.||-0.117|-0.411|
91556157|NCT03542305|183000478|OTHER||Ratio (%) of Adjusted Geometric Means|104.25|||||TWO_SIDED|90.0|79.73|136.31|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||136.31|79.73|
91556158|NCT03542305|183000478|OTHER||Ratio (%) of Adjusted Geometric Means|118.75|||||TWO_SIDED|90.0|91.43|154.24|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||154.24|91.43|
91556159|NCT03542305|183000478|OTHER||Ratio (%) of Adjusted Geometric Means|141.14|||||TWO_SIDED|90.0|97.82|203.66|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||203.66|97.82|
91556160|NCT03542305|183000479|OTHER||Ratio (%) of Adjusted Geometric Means|100.53|||||TWO_SIDED|90.0|66.48|152.02|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||152.02|66.48|
91556161|NCT03542305|183000479|OTHER||Slope|88.87|||||TWO_SIDED|90.0|64.18|123.06|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||123.06|64.18|
91556162|NCT03542305|183000479|OTHER||Ratio (%) of Adjusted Geometric Means|92.32|||||TWO_SIDED|90.0|56.58|150.63|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||150.63|56.58|
91556163|NCT01619059|183000490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||Tested at alpha=0.05|Mixed Models Analysis|||||-0.18|-0.52|<0.0001
91556164|NCT01619059|183000491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|4.576||0.2014|TWO_SIDED|95.0|-14.9|3.1||Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure|Mixed Models Analysis|||||3.1|-14.9|0.2014
91556165|NCT01619059|183000492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.713|||TWO_SIDED|95.0|-11.0|3.6||||||||3.6|-11.0|
91556166|NCT01619059|183000493|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.504|||TWO_SIDED|95.0|3.4|21.0||||||||21.0|3.4|
91556167|NCT00853593|183000509|SUPERIORITY_OR_OTHER||One sample proportion|0.951|||||ONE_SIDED|95.0|0.906||||||The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).||||.906|
91556168|NCT00853593|183000510|SUPERIORITY_OR_OTHER||One sample mean|1.6|STANDARD_DEVIATION|1.4|||ONE_SIDED|95.0||1.8||||||||1.8||
91768343|NCT02365649|183425689|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.564|TWO_SIDED|95.0|-12.5|22.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.9|-12.5|0.564
91768344|NCT02365649|183425689|SUPERIORITY||Adjusted risk difference from placebo|12.0||||0.221|TWO_SIDED|95.0|-7.2|31.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.2|-7.2|0.221
91768345|NCT02365649|183425689|SUPERIORITY||Adjusted risk difference from placebo|22.2||||0.036|TWO_SIDED|95.0|1.4|43.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43|1.4|0.036
91768346|NCT02365649|183425689|SUPERIORITY||Adjusted risk difference from placebo|13.4||||0.179|TWO_SIDED|95.0|-6.2|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.2|0.179
91768347|NCT02365649|183425689|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.677|TWO_SIDED|95.0|-14.3|22.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22|-14.3|0.677
91556169|NCT00853593|183000511|SUPERIORITY_OR_OTHER||One sample mean|2.3|STANDARD_DEVIATION|2.0|||ONE_SIDED|97.5||2.7||||||||2.7||
91556170|NCT00853593|183000512|SUPERIORITY_OR_OTHER||One sample proportion|0.927|||||TWO_SIDED|95.0|0.887|0.967||||||||.967|.887|
91556171|NCT00853593|183000513|SUPERIORITY_OR_OTHER||One sample proportion|0.969|||||TWO_SIDED|95.0|0.944|0.993||||||||.993|.944|
91556172|NCT00853593|183000514|SUPERIORITY_OR_OTHER||One sample proportion|0.959|||||TWO_SIDED|95.0|0.93|0.987||||||||.987|.930|
91556173|NCT00853593|183000515|SUPERIORITY_OR_OTHER||One sample proportion|0.948|||||TWO_SIDED|95.0|0.917|0.979||||||||.979|.917|
91556174|NCT00853593|183000521|SUPERIORITY_OR_OTHER||One sample mean|2.4|STANDARD_DEVIATION|1.9|||ONE_SIDED|95.0||2.7||||||||2.7||
91556175|NCT03170648|183000547|OTHER|||||||0.02||||||T2 (post) vs.T1(pre)|t-test, 2 sided|||||||0.02
91556176|NCT01367236|183000555|SUPERIORITY|||||||0.68|||||||Regression, Linear|||24 weeks||||0.68
91556177|NCT01367236|183000555|SUPERIORITY|||||||0.43|||||||Regression, Linear|||48 weeks||||0.43
91556178|NCT01367236|183000556|SUPERIORITY|||||||0.0009|||||||Regression, Linear|||||||0.0009
91556179|NCT02628626|183000579|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
91556180|NCT02628626|183000580|SUPERIORITY|||||||0.24|||||||ANCOVA|||Approximately 4 weeks||||0.24
91556181|NCT02628626|183000581|SUPERIORITY|||||||0.44|||||||ANCOVA|||Approximately 4 weeks||||0.44
91556182|NCT02628626|183000582|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
91556183|NCT02628626|183000583|SUPERIORITY|||||||0.56|||||||ANCOVA|||Approximately 4 weeks||||0.56
91556184|NCT02628626|183000584|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
91556185|NCT02628626|183000585|SUPERIORITY|||||||0.11|||||||ANCOVA|||Small (staining only)||||0.11
91556186|NCT02628626|183000585|SUPERIORITY|||||||0.06|||||||ANCOVA|||Moderate (requires change of underwear)||||0.06
91556187|NCT02628626|183000585|SUPERIORITY|||||||0.36|||||||ANCOVA|||Large (requires complete change of clothes)||||0.36
91556188|NCT02628626|183000586|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
91556189|NCT02628626|183000587|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
91556190|NCT02628626|183000588|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
91556191|NCT02628626|183000589|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
91556192|NCT02628626|183000590|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
91556193|NCT02628626|183000591|SUPERIORITY|approximately 4 weeks post-treatment||||||0.12|||||||ANCOVA|||||||0.12
91556194|NCT02628626|183000592|SUPERIORITY|||||||0.67|||||||ANCOVA|||Lifestyle Score||||0.67
91556195|NCT02628626|183000592|SUPERIORITY|||||||0.8|||||||ANCOVA|||Coping Score||||0.80
91768348|NCT02365649|183425690|SUPERIORITY||Adjusted risk difference from placebo|10.4||||0.363|TWO_SIDED|95.0|-12.0|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-12|0.363
91768349|NCT02365649|183425690|SUPERIORITY||Adjusted risk difference from placebo|17.3||||0.137|TWO_SIDED|95.0|-5.5|40.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40|-5.5|0.137
91768350|NCT02365649|183425690|SUPERIORITY||Adjusted risk difference from placebo|7.5||||0.512|TWO_SIDED|95.0|-14.9|29.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.9|-14.9|0.512
91768351|NCT02365649|183425690|SUPERIORITY||Adjusted risk difference from placebo|25.0||||0.035|TWO_SIDED|95.0|-1.8|48.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.2|-1.8|0.035
91556196|NCT02628626|183000592|SUPERIORITY|||||||0.49|||||||ANCOVA|||Depression Score||||0.49
91556197|NCT02628626|183000592|SUPERIORITY|||||||0.6|||||||ANCOVA|||Embarrassment Score||||0.60
91556198|NCT02628626|183000593|SUPERIORITY|||||||0.78|||||||ANCOVA|||Approximately 4 weeks post-treatment||||0.78
91556199|NCT02962102|183000637|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
91556200|NCT02962102|183000637|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
91556201|NCT02962102|183000638|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
91556202|NCT02962102|183000638|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
91556203|NCT02962102|183000639|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
91556204|NCT02962102|183000639|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91556205|NCT01855750|183000649|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.5167|TWO_SIDED|95.0|0.72|1.18|||Log Rank|||||1.180|0.720|0.5167
91556206|NCT01855750|183000650|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.7311|TWO_SIDED|95.0|0.704|1.279|||Log Rank|||||1.279|0.704|0.7311
91556207|NCT01855750|183000651|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.5027|TWO_SIDED|95.0|0.71|1.183|||Log Rank|||||1.183|0.710|0.5027
91556208|NCT01855750|183000652|SUPERIORITY||Odds Ratio (OR)|0.967||||0.8229|TWO_SIDED|95.0|0.722|1.296|||Cochran-Mantel-Haenszel (CMH) Chi-square|||||1.296|0.722|0.8229
91556209|NCT01855750|183000653|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8549|TWO_SIDED|95.0|0.754|1.407|||Log Rank|||||1.407|0.754|0.8549
91556210|NCT01855750|183000654|SUPERIORITY||Hazard Ratio (HR)|1.358||||0.0021|TWO_SIDED|95.0|1.115|1.654|||Log Rank|||||1.654|1.115|0.0021
91556211|NCT03160885|183000704|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|11.1|||<|0.001|TWO_SIDED|95.0|5.8|16.4||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||16.4|5.8|<0.001
91556212|NCT03160885|183000705|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.3||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||27.3|15.8|<0.001
91556213|NCT03160885|183000706|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|10.3|20.9||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders'.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance||20.9|10.3|<0.001
91556214|NCT03160885|183000707|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-14.0|||<|0.001|TWO_SIDED|95.0|-18.0|-10.1||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-10.1|-18.0|<0.001
91556215|NCT03160885|183000708|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-3.9|||<|0.001|TWO_SIDED|95.0|-5.2|-2.6||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-2.6|-5.2|<0.001
91556216|NCT03160885|183000709|SUPERIORITY||Risk Difference (RD)|34.1||||0.004|TWO_SIDED|95.0|13.4|54.9||Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||54.9|13.4|0.004
91556217|NCT03160885|183000709|SUPERIORITY||Risk Difference (RD)|19.9||||0.084|TWO_SIDED|95.0|-1.2|40.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant"|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||40.9|-1.2|0.084
91768352|NCT02365649|183425690|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.29|TWO_SIDED|95.0|-10.7|35.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.6|-10.7|0.29
91768353|NCT02365649|183425691|SUPERIORITY||Adjusted risk difference from placebo|-0.9||||0.896|TWO_SIDED|95.0|-15.0|13.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||13.1|-15.0|0.896
91768354|NCT02365649|183425691|SUPERIORITY||Adjusted risk difference from placebo|18.6||||0.05|TWO_SIDED|95.0|0.0|37.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.3|0.0|0.05
91556218|NCT03160885|183000710|SUPERIORITY||Risk Difference (RD)|33.7|||<|0.001|TWO_SIDED|95.0|17.3|50.0||Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||50.0|17.3|<0.001
91556219|NCT03160885|183000710|SUPERIORITY||Risk Difference (RD)|30.0||||0.001|TWO_SIDED|95.0|13.7|46.4||Test not evaluated for statistical significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||46.4|13.7|0.001
91556220|NCT03160885|183000713|SUPERIORITY||Risk Difference (RD)|29.3|||<|0.001|TWO_SIDED|95.0|22.5|36.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||36.1|22.5|<0.001
91556221|NCT03160885|183000714|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.0||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||17.0|8.3|<0.001
91556222|NCT03160885|183000715|SUPERIORITY||Difference of least square means|-9.9|||<|0.001|TWO_SIDED|95.0|-12.2|-7.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-7.5|-12.2|<0.001
91556223|NCT03160885|183000716|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.001|TWO_SIDED|95.0|4.4|11.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||11.6|4.4|<0.001
91556224|NCT03160885|183000717|SUPERIORITY||Risk Difference (RD)|18.9|||<|0.001|TWO_SIDED|95.0|12.8|25.1||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||25.1|12.8|<0.001
91768355|NCT02365649|183425691|SUPERIORITY||Adjusted risk difference from placebo|3.0||||0.702|TWO_SIDED|95.0|-12.4|18.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||18.4|-12.4|0.702
91556225|NCT03160885|183000718|SUPERIORITY||Difference of least square means|-1.3|||<|0.001|TWO_SIDED|95.0|-1.7|-0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.8|-1.7|<0.001
91556226|NCT03160885|183000719|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.9|26.2||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||26.2|13.9|<0.001
91556227|NCT03160885|183000720|SUPERIORITY||Risk Difference (RD)|28.9|||<|0.001|TWO_SIDED|95.0|21.4|36.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||36.3|21.4|<0.001
91556228|NCT03835754|183000725|OTHER|Confidence internal is 88.8%, upper bound limit 99.2%|Clopper Pearson exact confidence interva|96.0|||||TWO_SIDED|95.0|88.8|99.2||||||||99.2|88.8|
91768356|NCT02365649|183425691|SUPERIORITY||Adjusted risk difference from placebo|14.3||||0.117|TWO_SIDED|95.0|-3.6|32.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.2|-3.6|0.117
91768357|NCT02365649|183425691|SUPERIORITY||Adjusted risk difference from placebo|-2.4||||0.736|TWO_SIDED|95.0|-16.4|11.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||11.6|-16.4|0.736
91768358|NCT02365649|183425692|SUPERIORITY||Adjusted risk difference from placebo|2.9||||0.276|TWO_SIDED|95.0|-2.3|8.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.1|-2.3|0.276
91768359|NCT02365649|183425692|SUPERIORITY||Adjusted risk difference from placebo|4.9||||0.195|TWO_SIDED|95.0|-2.5|12.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.4|-2.5|0.195
91556229|NCT05886777|183000763|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.782|1.249|||||GMRs and 2-sided confidence intervals (CIs) were calculated by exponentiating mean differences of logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.249|0.782|
91556230|NCT05886777|183000764|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.9|||||TWO_SIDED|97.5|0.697|1.162|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.162|0.697|
91556231|NCT05886777|183000765|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.605|1.168|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and corresponding CIs (based on the Student t distribution).|||1.168|0.605|
91556232|NCT05886777|183000766|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.79|||||TWO_SIDED|97.5|0.618|1.014|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.014|0.618|
91556233|NCT05886777|183000767|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.06|||||TWO_SIDED|97.5|0.785|1.423|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.423|0.785|
91768360|NCT02365649|183425692|SUPERIORITY||Adjusted risk difference from placebo|2.6||||0.355|TWO_SIDED|95.0|-2.9|8.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.0|-2.9|0.355
91768361|NCT02365649|183425692|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
91556234|NCT05886777|183000768|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.13|||||TWO_SIDED|97.5|0.909|1.402|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.402|0.909|
91768362|NCT02365649|183425692|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.9|-2.5|0.185
91768363|NCT02365649|183425693|SUPERIORITY||Adjusted risk difference from placebo|13.2||||0.05|TWO_SIDED|95.0|0.0|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|0.0|0.05
91768364|NCT02365649|183425693|SUPERIORITY||Adjusted risk difference from placebo|29.5||||0.001|TWO_SIDED|95.0|11.9|47.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||47.1|11.9|0.001
91556235|NCT05886777|183000769|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.05|||||TWO_SIDED|97.5|0.773|1.434|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.434|0.773|
91556236|NCT05886777|183000770|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.11|||||TWO_SIDED|97.5|0.807|1.515|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.515|0.807|
91556237|NCT05886777|183000771|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.0|||||TWO_SIDED|97.5|0.769|1.288|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.288|0.769|
91556238|NCT05886777|183000772|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.09|||||TWO_SIDED|97.5|0.836|1.429|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.429|0.836|
91556239|NCT05886777|183000773|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.594|1.19|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.190|0.594|
91556240|NCT05886777|183000774|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.632|1.125|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.125|0.632|
91556241|NCT05886777|183000775|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.42|||||TWO_SIDED|97.5|1.123|1.801|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.801|1.123|
91768365|NCT02365649|183425693|SUPERIORITY||Adjusted risk difference from placebo|25.2||||0.003|TWO_SIDED|95.0|8.5|42.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||42.0|8.5|0.003
91768366|NCT02365649|183425693|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|17.6|55.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||55.4|17.6|< 0.001
91768367|NCT02365649|183425693|SUPERIORITY||Adjusted risk difference from placebo|32.0|||<|0.001|TWO_SIDED|95.0|13.9|50.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.2|13.9|< 0.001
91768368|NCT02365649|183425694|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.243|TWO_SIDED|95.0|-7.2|28.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.2|-7.2|0.243
91768369|NCT02365649|183425694|SUPERIORITY||Adjusted risk difference from placebo|29.1||||0.006|TWO_SIDED|95.0|8.3|49.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.9|8.3|0.006
91556242|NCT05886777|183000776|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.27|||||TWO_SIDED|97.5|0.977|1.651|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.651|0.977|
91556243|NCT05886777|183000777|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7,3, respectively.|Geometric mean ratio|0.86|||||TWO_SIDED|97.5|0.61|1.208|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.208|0.610|
91556244|NCT05886777|183000778|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 3, respectively.|Geometric mean ratio|1.01|||||TWO_SIDED|97.5|0.764|1.34|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.340|0.764|
91556245|NCT05886777|183000779|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|2.49|||||TWO_SIDED|97.5|1.914|3.232|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||3.232|1.914|
91556246|NCT05886777|183000780|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.3|||||TWO_SIDED|97.5|1.049|1.612|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.612|1.049|
91556247|NCT05886777|183000781|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.58|||||TWO_SIDED|97.5|1.155|2.165|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||2.165|1.155|
91556248|NCT05886777|183000782|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|3.49|||||TWO_SIDED|97.5|2.64|4.604|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||4.604|2.640|
91556249|NCT05886777|183000783|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.43|||||TWO_SIDED|97.5|1.131|1.808|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.808|1.131|
91556250|NCT05886777|183000784|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.37|||||TWO_SIDED|97.5|1.06|1.773|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.773|1.060|
91556251|NCT05886777|183000785|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.673|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.300|0.673|
91768370|NCT02365649|183425694|SUPERIORITY||Adjusted risk difference from placebo|24.2||||0.017|TWO_SIDED|95.0|4.4|44.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||44.1|4.4|0.017
91556252|NCT05886777|183000786|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.97|||||TWO_SIDED|97.5|0.74|1.281|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.281|0.740|
91556253|NCT00918333|183000825|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|40.0|||||TWO_SIDED|||||||||||||
91556254|NCT01728324|183000882|SUPERIORITY_OR_OTHER||Adjusted response rate|81.1|||<|0.0001|TWO_SIDED|95.0|76.34|85.87|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.|The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).|The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||85.87|76.34|<0.0001
91556255|NCT01728324|183000882|SUPERIORITY_OR_OTHER||Adjusted response rate|75.89||||0.002|TWO_SIDED|95.0|70.63|81.14|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.||The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||81.14|70.63|0.0020
91556256|NCT01728324|183000883|SUPERIORITY_OR_OTHER||SVR12 Rates difference|6.4||||0.0532|TWO_SIDED|95.0|-1.4|14.2|||Koch's method|Adjusted for PegIFN eligibility using Koch's method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||14.2|-1.4|0.0532
91556257|NCT01728324|183000884|SUPERIORITY_OR_OTHER||SVR4 Rates difference|3.6||||0.1671|TWO_SIDED|95.0|-3.7|10.9|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||10.9|-3.7|0.1671
91556258|NCT01728324|183000885|SUPERIORITY_OR_OTHER||SVR24 Rates difference|-6.9||||0.0447|TWO_SIDED|95.0|-14.8|1.1|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||1.1|-14.8|0.0447
91556259|NCT01787032|183000889|SUPERIORITY_OR_OTHER||Ratio|373.66|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|346.029|403.507|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||403.507|346.029|
91556260|NCT01787032|183000889|SUPERIORITY_OR_OTHER||Ratio|266.94|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|243.267|292.914|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.914|243.267|
91768371|NCT02365649|183425694|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|14.8|58.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.1|14.8|< 0.001
91556261|NCT01787032|183000890|SUPERIORITY_OR_OTHER||Ratio|261.34|STANDARD_DEVIATION|37.3|||TWO_SIDED|90.0|211.692|322.633|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||322.633|211.692|
91556262|NCT01787032|183000890|SUPERIORITY_OR_OTHER||Ratio|213.39|STANDARD_DEVIATION|34.1|||TWO_SIDED|90.0|175.783|259.051|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||259.051|175.783|
91556263|NCT01787032|183000891|SUPERIORITY_OR_OTHER||Ratio|372.88|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|345.456|402.477|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||402.477|345.456|
91556264|NCT01787032|183000891|SUPERIORITY_OR_OTHER||Ratio|266.56|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|242.955|292.456|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.456|242.955|
91556265|NCT03229408|183000950|SUPERIORITY||||||<|0.004|||||||Unpaired t-test, 2-Sided|||||||<0.004
91768372|NCT02365649|183425694|SUPERIORITY||Adjusted risk difference from placebo|36.8|||<|0.001|TWO_SIDED|95.0|15.2|58.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.3|15.2|< 0.001
91768373|NCT02365649|183425695|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.353|TWO_SIDED|95.0|-11.7|32.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.7|-11.7|0.353
91556266|NCT03229408|183000951|SUPERIORITY||||||<|0.03|||||||Unpaired T-test, 2-Sided|||||||<0.03
91556267|NCT03229408|183000952|SUPERIORITY|||||||0.18|||||||Unpaired t-test, 2-Sided|||||||0.180
91556268|NCT03229408|183000953|SUPERIORITY||||||<|0.002|||||||Unpaired T-test, 2-Sided|||||||<0.002
91556269|NCT03229408|183000954|SUPERIORITY||||||<|0.04|||||||Unpaired t-test, 2-Sided|||||||<0.04
91556270|NCT03229408|183000955|SUPERIORITY||||||<|0.003|||||||Unpaired t-test, 2-Sided|||||||<0.003
91556271|NCT03229408|183000956|SUPERIORITY||||||<|0.0004|||||||Unpaired t-test, 2-Sided|||||||<0.0004
91768374|NCT02365649|183425695|SUPERIORITY||Adjusted risk difference from placebo|22.7||||0.05|TWO_SIDED|95.0|0.0|45.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||45.5|0.0|0.05
91768375|NCT02365649|183425695|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.268|TWO_SIDED|95.0|-9.6|34.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.6|-9.6|0.268
91768376|NCT02365649|183425695|SUPERIORITY||Adjusted risk difference from placebo|28.0||||0.018|TWO_SIDED|95.0|4.8|51.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||51.2|4.8|0.018
91556272|NCT03229408|183000957|SUPERIORITY||||||<|0.007|||||||Unpaired t-test, 2-Sided|||||||<0.007
91768377|NCT02365649|183425695|SUPERIORITY||Adjusted risk difference from placebo|14.9||||0.204|TWO_SIDED|95.0|-8.1|37.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.8|-8.1|0.204
91556273|NCT06193590|183000960|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
91556274|NCT06193590|183000961|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.1
91556275|NCT06193590|183000963|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
91556276|NCT01706159|183000968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.3056||90.0|0.01|3.05||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher's exact test.||3.05|0.01|0.3056
91556277|NCT05116163|183000984|SUPERIORITY||Mean Difference (Final Values)|7.83|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED||||||t-test, 2 sided||Difference in the mean of percent of quality metrics achieved in the intervention arm minus the control arm.|||||<0.001
91556278|NCT05116163|183000985|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1164|TWO_SIDED||||||t-test, 2 sided|||||||0.1164
91556279|NCT05116163|183000986|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.6781|TWO_SIDED||||||t-test, 2 sided||Intervention group mean - control group mean|||||0.6781
91556280|NCT05116163|183000987|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.4795|TWO_SIDED||||||t-test, 2 sided||Intervention group mean - control group mean|||||0.4795
91556281|NCT05116163|183000988|SUPERIORITY|||||||0.056|||||||Regression, Linear|||Comparison of 3-month vs. baseline adherence scores in patients of providers in the intervention arm vs. control||||0.056
91556282|NCT05116163|183000989|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.017|TWO_SIDED||||||t-test, 2 sided|||||||0.017
91556283|NCT05116163|183000990|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.3957|TWO_SIDED||||||t-test, 2 sided||Mean from intervention arm - control arm.|||||0.3957
91556284|NCT05116163|183000991|SUPERIORITY||Incidence Rate Ratio|1.02|||||TWO_SIDED|95.0|0.63|1.64||||||Comparing the incidence rate of ED visits for the intervention vs. control arms.||1.64|0.63|
91556285|NCT05116163|183000992|SUPERIORITY||Incidence Rate Ratio|1.21|||||TWO_SIDED|95.0|1.07|1.36||||||Incidence rate ratio comparing incidence rates of outpatient visits in the intervention vs. control arms.||1.36|1.07|
91556286|NCT05116163|183000993|SUPERIORITY||Incidence Rate Ratio|4.06|||||TWO_SIDED|95.0|1.69|9.73||||||Incidence rate ratio comparing the incidence rates of hospitalizations in the intervention vs. control arm patients.||9.73|1.69|
91556287|NCT05116163|183000994|SUPERIORITY|||||||0.3882|||||||t-test, 2 sided|||Post vs. pre IAT d-scores comparing the intervention vs. control arms.||||0.3882
91556288|NCT05116163|183000995|SUPERIORITY|||||||0.3615|||||||t-test, 2 sided|||Comparing post vs. pre IAT d-scores between the intervention and control groups.||||0.3615
91556289|NCT05116163|183000996|SUPERIORITY|||||||0.9432|||||||t-test, 2 sided|||Comparing post vs pre IAT d-scores in the intervention vs. control arms.||||0.9432
91556290|NCT05116163|183000997|SUPERIORITY|||||||0.1453|||||||t-test, 2 sided|||Post vs pre IAT d-scores for the intervention vs. control arms.||||0.1453
91556291|NCT05613907|183001044|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.885||0.005|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.005
91556292|NCT05613907|183001044|SUPERIORITY||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|6.512||0.04|TWO_SIDED|95.0|-34.895|-0.705|||ANOVA|||||-0.705|-34.895|0.040
91556293|NCT05613907|183001044|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.668||0.94|TWO_SIDED|95.0|-5.829|13.429|||ANOVA|||||13.429|-5.829|0.940
91556294|NCT05613907|183001045|SUPERIORITY||Z statistic|-0.862||||0.388|TWO_SIDED||||||Wilcoxon Signed Ranks|||The null hypothesis is that there will be no significant difference in the EuroQol 5-D domains at 1 year compared to baseline.||||0.388
91556295|NCT05613907|183001046|SUPERIORITY||Z statistic|-0.033||||0.974|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is that there will be no statistical difference in patient self-reported ability to perform basic self-care||||0.974
91556296|NCT05613907|183001047|SUPERIORITY||Z statistic|-1.564||||0.118|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is no improvement in ability to perform usual activities at 1 year.||||0.118
91556297|NCT05613907|183001048|SUPERIORITY||Z statistic|-2.364||||0.018|TWO_SIDED||||||Wilcoxon signed rank|||||||0.018
91768378|NCT02365649|183425696|SUPERIORITY||Adjusted risk difference from placebo|10.0||||0.421|TWO_SIDED|95.0|-14.4|34.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.4|-14.4|0.421
91768379|NCT02365649|183425696|SUPERIORITY||Adjusted risk difference from placebo|11.5||||0.371|TWO_SIDED|95.0|-13.8|36.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||36.8|-13.8|0.371
91768380|NCT02365649|183425696|SUPERIORITY||Adjusted risk difference from placebo|9.2||||0.445|TWO_SIDED|95.0|-14.4|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-14.4|0.445
91768381|NCT02365649|183425696|SUPERIORITY||Adjusted risk difference from placebo|19.5||||0.198|TWO_SIDED|95.0|-10.2|49.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.3|-10.2|0.198
91556298|NCT05613907|183001049|SUPERIORITY||Z statistic|-1.311||||0.19|TWO_SIDED|||||The null hypothesis is that there will be no difference in anxiety and/or depression compared to the initial visit.|Wilcoxon signed rank|||||||0.190
91556299|NCT05613907|183001050|SUPERIORITY||Mean Difference (Net)|-26.846|STANDARD_ERROR_OF_MEAN|8.604||0.027|TWO_SIDED|95.0|-50.762|-2.39|||ANOVA|||||-2.390|-50.762|0.027
91556300|NCT05613907|183001050|SUPERIORITY||Mean Difference (Net)|-27.615|STANDARD_ERROR_OF_MEAN|8.715||0.024|TWO_SIDED|95.0|-51.837|-3.394|||ANOVA|||||-3.394|-51.837|0.024
91556301|NCT05613907|183001050|SUPERIORITY||Mean Difference (Net)|-0.769|STANDARD_ERROR_OF_MEAN|4.535||1|TWO_SIDED|95.0|-13.374|11.836|||ANOVA|||||11.836|-13.374|1.000
91556302|NCT05613907|183001051|SUPERIORITY||Mean Difference (Net)|-14.27|STANDARD_ERROR_OF_MEAN|4.052||0.048|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.048
91556303|NCT05613907|183001051|SUPERIORITY||Median Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|3.751||1|TWO_SIDED|95.0|-12.893|13.751|||ANOVA|||||13.751|-12.893|1.000
91768382|NCT02365649|183425696|SUPERIORITY||Adjusted risk difference from placebo|5.0||||0.654|TWO_SIDED|95.0|-17.0|27.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||27.0|-17.0|0.654
91556304|NCT05613907|183001051|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|5.186||0.163|TWO_SIDED|95.0|-4.762|29.333|||ANOVA|||||29.333|-4.762|0.163
91768383|NCT02365649|183425697|SUPERIORITY||Adjusted risk difference from placebo|18.7||||0.093|TWO_SIDED|95.0|-3.1|40.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.5|-3.1|0.093
91556305|NCT05080777|183001052|EQUIVALENCE|Group, Time, and Group x Time effect tests were performed using MLM.||||||0.295||||||.P-value shown is based on the Group x Time F statistic used in multilevel modeling (MLM)|Multilevel modeling (MLM)|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.295
91556306|NCT05080777|183001053|EQUIVALENCE|Group, time, and group x time effect tests were performed using multilevel modeling (MLM).||||||0.57||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.570
91556307|NCT05080777|183001054|EQUIVALENCE|Group, time, and time x group effect tests were performed using multilevel modeling (MLM).||||||0.461||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.461
91556308|NCT03789656|183001097|OTHER|||||||0.6285|||||||Wilcoxon Signed Rank test|||The primary efficacy endpoint was completed with the Efficacy Analysis Set (EAS), which included all treated subjects in Group 1. The median (Interquartile range) for change from baseline in IGF-1xULN to Week 13/EoT and p-value from the Wilcoxon signed rank test were presented. Baseline was defined as the mean of all IGF-1xULN values prior to first dose. Last on treatment assessment was used for EoT if subject discontinued before Week 13.||||0.6285
91556309|NCT03789656|183001098|OTHER|||||||0.3877|||||||exact binomial test assuming the null pr|Null proportion = 0.5||||||0.3877
91556310|NCT01586104|183001103|OTHER|With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.|||||<|0.0125||||||The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.|Bonferroni corrected at p<0.0125|||Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.|Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).|||<0.0125
91556311|NCT05256797|183001106|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.66|0.71||||||Hazard ratio||0.71|0.66|
91556312|NCT04484623|183001113|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.73||P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.|Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.|||0.73|0.37|<0.001
91556313|NCT06214052|183001156|OTHER||Emax|-2.69|STANDARD_ERROR_OF_MEAN|5.0||||||||||||||||
91556314|NCT06214052|183001156|OTHER||EC50|1.88|STANDARD_ERROR_OF_MEAN|26.0||||||||||||||||
91768384|NCT02365649|183425697|SUPERIORITY||Adjusted risk difference from placebo|13.5||||0.176|TWO_SIDED|95.0|-6.1|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.1|0.176
91556315|NCT05325294|183001160|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.1||||0.133|TWO_SIDED|95.0|-0.2|0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||0.1|-0.2|0.133
91556316|NCT05325294|183001160|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
91556317|NCT05325294|183001161|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
91556318|NCT05325294|183001161|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
91556319|NCT05325294|183001162|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.5|0.3|<0.001
91768385|NCT02365649|183425697|SUPERIORITY||Adjusted risk difference from placebo|35.9||||0.017|TWO_SIDED|95.0|6.3|65.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||65.5|6.3|0.017
91768386|NCT02365649|183425697|SUPERIORITY||Adjusted risk difference from placebo|26.1||||0.044|TWO_SIDED|95.0|0.7|51.5|||Cochran-Mantel-Haenszel|||||51.5|0.7|0.044
91768387|NCT02365649|183425697|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
91768388|NCT02365649|183425698|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.564|TWO_SIDED|95.0|-8.1|14.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||14.9|-8.1|0.564
91768389|NCT02365649|183425698|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
91556320|NCT05325294|183001162|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.2|||<|0.001|TWO_SIDED|95.0|0.2|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.3|0.2|<0.001
91556321|NCT05325294|183001163|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
91556322|NCT05325294|183001163|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
91556323|NCT04649047|183001164|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-2.92||||0.036|TWO_SIDED|95.0|-5.6|-0.23|||t-test, 2 sided|||||-0.23|-5.6|0.036
91556324|NCT04649047|183001165|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-0.56||||-0.77|TWO_SIDED|95.0|-1.02|-0.1|||t-test, 2 sided|||||-0.10|-1.02|-0.77
91556325|NCT04649047|183001166|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.42||||-0.51|TWO_SIDED|95.0|-7.69|0.85|||t-test, 2 sided|||||0.85|-7.69|-0.51
91556326|NCT04649047|183001167|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|0.85||||0.49|TWO_SIDED|95.0|-0.32|2.03|||t-test, 2 sided|||||2.03|-0.32|0.49
91556327|NCT04649047|183001168|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-8.54||||-0.48|TWO_SIDED|95.0|-19.9|2.82|||t-test, 2 sided|||||2.82|-19.9|-0.48
91556328|NCT04649047|183001169|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|64.46||||0.13|TWO_SIDED|95.0|-256.0|384.7|||t-test, 2 sided|||||384.7|-256|0.13
91768390|NCT02365649|183425698|SUPERIORITY||Adjusted risk difference from placebo|8.7||||0.326|TWO_SIDED|95.0|-8.7|26.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.1|-8.7|0.326
91768391|NCT02365649|183425699|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.195|TWO_SIDED|95.0|-6.2|30.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||30.7|-6.2|0.195
91768392|NCT02365649|183425699|SUPERIORITY||Adjusted risk difference from placebo|17.9||||0.116|TWO_SIDED|95.0|-4.4|40.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.1|-4.4|0.116
91768393|NCT02365649|183425699|SUPERIORITY||Adjusted risk difference from placebo|12.8||||0.178|TWO_SIDED|95.0|-5.8|31.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.5|-5.8|0.178
91556329|NCT04649047|183001170|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.5||||0.88|TWO_SIDED|95.0|0.98|6.02|||t-test, 2 sided|||||6.02|0.98|0.88
91556330|NCT04649047|183001171|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.67||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
91556331|NCT04649047|183001172|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.5||||0.78|TWO_SIDED|95.0|0.82|8.18|||t-test, 2 sided|||||8.18|0.82|0.78
91556332|NCT04649047|183001173|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.42||||0.58|TWO_SIDED|95.0|-0.32|7.16|||t-test, 2 sided|||||7.16|-0.32|0.58
91556333|NCT04649047|183001174|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.42||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
91556334|NCT04649047|183001175|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.83||||0.46|TWO_SIDED|95.0|-1.5|9.16|||t-test, 2 sided|||||9.16|-1.50|0.46
91556335|NCT04649047|183001176|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.08||||0.71|TWO_SIDED|95.0|0.43|7.73|||t-test, 2 sided|||||7.73|0.43|0.71
91556336|NCT04649047|183001177|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.67||||-0.52|TWO_SIDED|95.0|-8.12|0.79|||t-test, 2 sided|||||0.79|-8.12|-0.52
91768394|NCT02365649|183425699|SUPERIORITY||Adjusted risk difference from placebo|30.4||||0.031|TWO_SIDED|95.0|2.8|58.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.0|2.8|0.031
91768395|NCT02365649|183425699|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
91768396|NCT02365649|183425700|SUPERIORITY||Adjusted risk difference from placebo|6.8||||0.392|TWO_SIDED|95.0|-8.7|22.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.2|-8.7|0.392
91556337|NCT04172675|183001207|SUPERIORITY||Hazard Ratio (HR)|0.28|||=|0.0007|TWO_SIDED|95.0|0.13|0.61|||Unstratified Log rank||Hazard ratio and 95% CI were estimated using a Cox proportional hazards regression model.|||0.61|0.13|=0.0007
91556338|NCT00378898|183001214|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
91556339|NCT06307457|183001222|OTHER|||||||0.031|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.031
91556340|NCT06307457|183001223|OTHER|||||||0.012|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.012
91556341|NCT06307457|183001224|OTHER|||||||0.061|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.061
91556342|NCT06307457|183001225|OTHER|||||||0.08|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.080
91556343|NCT06307457|183001226|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.2
91556344|NCT06307457|183001227|OTHER|||||||0.093|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.093
91556345|NCT06307457|183001228|OTHER||||||>|0.9|||||||Log Rank|||Statistical data for participants with cardiac disease comorbidity reported.||||>0.9
91556346|NCT06307457|183001228|OTHER|||||||0.9|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.9
91556347|NCT06307457|183001228|OTHER|||||||0.4|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.4
91556348|NCT06307457|183001229|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants cardiac disease comorbidity reported.||||0.7
91556349|NCT06307457|183001229|OTHER|||||||0.3|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.3
91556350|NCT06307457|183001229|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.7
91556351|NCT06307457|183001230|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
91556352|NCT06307457|183001231|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
91556353|NCT06307457|183001232|OTHER|||||||0.14|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.14
91556354|NCT06307457|183001233|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.2
91556355|NCT06307457|183001234|OTHER|||||||0.047|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.047
91556356|NCT06307457|183001235|OTHER|||||||0.041|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.041
91556357|NCT01613417|183001349|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||0.8516|TWO_SIDED|95.0|-4.6|5.6||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||5.6|-4.6|0.8516
91768397|NCT02365649|183425700|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
91768398|NCT02365649|183425700|SUPERIORITY||Adjusted risk difference from placebo|13.0||||0.199|TWO_SIDED|95.0|-6.8|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-6.8|0.199
91768399|NCT02365649|183425700|SUPERIORITY||Adjusted risk difference from placebo|6.9||||0.439|TWO_SIDED|95.0|-10.6|24.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||24.5|-10.6|0.439
91556358|NCT01613417|183001349|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.0||||1|TWO_SIDED|95.0|-3.8|3.8||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||3.8|-3.8|1.0
91556359|NCT01613417|183001349|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||1|TWO_SIDED|95.0|-0.5|1.5||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||1.5|-0.5|1.0
91556360|NCT01613417|183001350|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556361|NCT01613417|183001350|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556362|NCT01613417|183001350|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556363|NCT01613417|183001351|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91768400|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-103.9||||0.788|TWO_SIDED|95.0|-865.69|657.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||657.87|-865.69|0.788
91768401|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-364.3||||0.325|TWO_SIDED|95.0|-1092.83|364.29||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||364.29|-1092.83|0.325
91556364|NCT01613417|183001351|SUPERIORITY_OR_OTHER|||||||0.6875|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||0.6875
91556365|NCT01613417|183001351|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556366|NCT01613417|183001352|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91768402|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-926.2||||0.015|TWO_SIDED|95.0|-1672.78|-179.63||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-179.63|-1672.78|0.015
91768403|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-763.1||||0.053|TWO_SIDED|95.0|-1534.52|8.39||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||8.39|-1534.52|0.053
91768404|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-359.5||||0.352|TWO_SIDED|95.0|-1119.52|400.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||400.56|-1119.52|0.352
91556367|NCT01613417|183001352|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556368|NCT01613417|183001352|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556369|NCT01613417|183001353|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556370|NCT01613417|183001353|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556371|NCT01613417|183001353|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
91556372|NCT01613417|183001354|SUPERIORITY_OR_OTHER|||||||0.2758|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.2758
91556373|NCT01613417|183001354|SUPERIORITY_OR_OTHER|||||||0.0676|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.0676
91556374|NCT01613417|183001354|SUPERIORITY_OR_OTHER|||||||0.5267|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.5267
91556375|NCT01613417|183001355|SUPERIORITY_OR_OTHER|||||||0.6201|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.6201
91556376|NCT01613417|183001355|SUPERIORITY_OR_OTHER|||||||0.4514|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.4514
91556377|NCT01613417|183001355|SUPERIORITY_OR_OTHER|||||||0.7722|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.7722
91556378|NCT01613417|183001356|SUPERIORITY_OR_OTHER|||||||0.3173|TWO_SIDED||||||McNemar|||||||0.3173
91556379|NCT01613417|183001356|SUPERIORITY_OR_OTHER|||||||0.5637|TWO_SIDED||||||McNemar|||||||0.5637
91556380|NCT01613417|183001356|SUPERIORITY_OR_OTHER|||||||0.0455|TWO_SIDED||||||McNemar|||||||0.0455
91556381|NCT01613417|183001357|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.6949
91768405|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-396.2||||0.503|TWO_SIDED|95.0|-1565.39|772.9||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||772.90|-1565.39|0.503
91556382|NCT01613417|183001357|SUPERIORITY_OR_OTHER|||||||0.1317|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.1317
91556383|NCT01613417|183001357|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.0124
91556384|NCT01429454|183001358|SUPERIORITY||Cox Proportional Hazard|0.36||||0.51|TWO_SIDED||||||Chi-squared|||||||.51
91556385|NCT01429454|183001359|SUPERIORITY||||||>|0.1|||||||Mixed Models Analysis|||||||>0.10
91556386|NCT02000752|183001360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||<|0.001|ONE_SIDED|95.0|7.59||||t-test, 1 sided||||||7.59|<0.001
91556387|NCT02000752|183001361|SUPERIORITY_OR_OTHER||difference in percentage|0.0||||1|TWO_SIDED|95.0|||||t-test, 2 sided|||||||1
91556388|NCT02000752|183001362|SUPERIORITY_OR_OTHER||difference in percentages|2.13||||0.16|ONE_SIDED|95.0|1.01||||t-test, 1 sided||||||1.01|0.16
91556389|NCT02000752|183001363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||0.2|ONE_SIDED|95.0|0.84||||t-test, 2 sided||||||0.84|0.2
91556390|NCT03392194|183001418|OTHER|The purpose of this small pilot randomized control trial (RCT) was to assess feasibility and acceptability of conducting community based sleep hygiene and yoga interventions, to be scaled and tested in a future, larger RCT.|Mean Difference (Net)|-2.02||||0.932|TWO_SIDED|95.0|-46.35|50.39|||t-test, 2 sided|Due to main findings, analysis to explore potential mediators of effect were not pursued, despite original plan to explore explanatory variables.||Null hypothesis: There is no difference in change in sleep duration between the two intervention arms.||50.39|-46.35|0.932
91556391|NCT02927249|183001429|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.91|1.56||||||||1.56|0.91|
91556392|NCT02927249|183001430|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.74|1.69||||||||1.69|0.74|
91556393|NCT02927249|183001431|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.83|1.52||||||||1.52|0.83|
91556394|NCT00229970|183001491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.022||95.0|0.01|0.16|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.16|0.01|0.022
91556395|NCT00229970|183001491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||<|0.001||95.0|0.09|0.24|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.24|0.09|<0.001
91556396|NCT01700205|183001499|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.018|||<|0.05|TWO_SIDED|95.0|-0.0363|-0.0002|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.||||-0.0002|-0.0363|<0.05
91556397|NCT01700205|183001500|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.|Slope|-0.023||||0.001|TWO_SIDED|95.0|-0.0362|-0.0093|||Generalized Estimating Equations|GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.||||-0.0093|-0.0362|0.001
91556398|NCT01700205|183001501|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.02||||0.32|TWO_SIDED|95.0|-0.058|0.019|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction||||0.019|-0.058|0.32
91556399|NCT01700205|183001502|OTHER|ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample|||||<|0.05|||||||Repeated Measures ANOVA|We conducted a ANOVA with group (CMF, EHF) as between-subject factor.||ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.||||<0.05
91556400|NCT01700205|183001503|OTHER|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||||||0.72|||||||Repeated Measure ANOVA|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor||||0.72
91768406|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-364.3||||0.537|TWO_SIDED|95.0|-1531.04|802.44||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||802.44|-1531.04|0.537
91556401|NCT01700205|183001504|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.72|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.72
91556402|NCT01700205|183001505|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.02|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.02
91556403|NCT03335488|183001514|SUPERIORITY||Odds Ratio (OR)|1.1||||1|TWO_SIDED|95.0|0.0|28.1|||Fisher Exact|||||28.1|0.0|1.0000
91556404|NCT03335488|183001516|SUPERIORITY|||||||0.8464|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 1||||0.8464
91556405|NCT03335488|183001516|SUPERIORITY|||||||0.104|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 2||||0.1040
91556406|NCT03335488|183001516|SUPERIORITY|||||||0.0979|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 3||||0.0979
91556407|NCT03335488|183001516|SUPERIORITY|||||||0.9808|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 0 Hr||||0.9808
91556408|NCT03335488|183001516|SUPERIORITY|||||||0.8329|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 4 Hr||||0.8329
91556409|NCT03335488|183001516|SUPERIORITY|||||||0.2544|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 8 Hr||||0.2544
91556410|NCT03335488|183001517|SUPERIORITY|||||||0.8579||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.8579
91556411|NCT03335488|183001518|SUPERIORITY|||||||0.7155||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.7155
91556412|NCT04941482|183001556|SUPERIORITY||Median Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.05|TWO_SIDED|95.0|-1.9|3.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Patient Health Questionnaire-9 score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.2|-1.9|<0.05
91556413|NCT04941482|183001557|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-7.6|2.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Fatigue Severity Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|2.5|-7.6|<0.05
91556414|NCT04941482|183001558|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-5.4|1.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Mini-Mental State Examinationscore before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|1.3|-5.4|<0.05
91556415|NCT04941482|183001559|SUPERIORITY|Over 6 months, the number of patients who losted to follow-up of intervention and control group were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.4|<|0.05|TWO_SIDED|95.0|-14.5|14.7|||t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Barthel Index score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|14.7|-14.5|<0.05
91556416|NCT04941482|183001560|SUPERIORITY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|5.6|<|0.05|TWO_SIDED|95.0|-18.8|3.7||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Physical domain score of Stroke Impact Scale before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.7|-18.8|<0.05
91556417|NCT04941482|183001561|SUPERIORITY||Mean Difference (Net)|-7.8|STANDARD_ERROR_OF_MEAN|-3.7|<|0.05|TWO_SIDED|95.0|-15.2|-0.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Stroke Impact Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|-0.3|-15.2|<0.05
91556418|NCT04200664|183001572|OTHER|Kendall tau b correlation analysis test was performed between the number of cognitive domains affected and the both ears 3-frequency pure tone average (at 0.5/1/2kHz) or both ears 4-frequency pure tone average (at 0.5/1/2/4kHz).|Kendall Tau-b|0.462||||0.176|TWO_SIDED||||||Kendall tau-b|Kendall tau b non-parametric correlation analysis was performed.||||||0.176
91556419|NCT00291694|183001574|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
91556420|NCT00291694|183001575|SUPERIORITY_OR_OTHER|||||||0.053||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Difference between groups, two-sided. Endpoint not specifically powered for effect.||||0.053
91556421|NCT00291694|183001576|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
91556422|NCT00291694|183001577|SUPERIORITY_OR_OTHER|||||||0.39||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.39
91556423|NCT00291694|183001578|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
91556424|NCT03371017|183001587|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.5891|TWO_SIDED|95.0|0.73|1.2|||Log Rank|||||1.20|0.73|0.5891
91556425|NCT03371017|183001588|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6139|TWO_SIDED|95.0|0.76|1.18|||Log Rank|||||1.18|0.76|0.6139
91556426|NCT03371017|183001589|SUPERIORITY||Difference in Event Free Rate|2.69||||0.6264|TWO_SIDED|95.0|-8.14|13.51|||Z-test|||||13.51|-8.14|0.6264
91556427|NCT03371017|183001590|SUPERIORITY||Difference in Event Free Rate|3.76||||0.475|TWO_SIDED|95.0|-6.55|14.07|||Z-test|||||14.07|-6.55|0.4750
91556428|NCT03371017|183001591|SUPERIORITY||Difference in Event Free Rate|1.15||||0.8315|TWO_SIDED|95.0|-9.45|11.75|||Z-test|||||11.75|-9.45|0.8315
91556429|NCT03371017|183001592|SUPERIORITY||Difference in Event Free Rate|1.37||||0.7738|TWO_SIDED|95.0|-7.96|10.69|||Z-test|||||10.69|-7.96|0.7738
91556430|NCT03371017|183001593|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1387|TWO_SIDED|95.0|0.67|1.06|||Log Rank|||||1.06|0.67|0.1387
91556431|NCT03371017|183001594|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7317|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7317
91556432|NCT03371017|183001595|SUPERIORITY||Difference in ORR|11.31||||0.0337|TWO_SIDED|95.0|0.24|22.37|||Cochran-Mantel-Haenszel|||||22.37|0.24|0.0337
91556433|NCT03371017|183001596|SUPERIORITY||Difference in ORR|-1.15||||0.9755|TWO_SIDED|95.0|-11.63|9.34|||Cochran-Mantel-Haenszel|||||9.34|-11.63|0.9755
91556434|NCT03371017|183001597|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1359|TWO_SIDED|95.0|0.48|1.11|||Log Rank|||||1.11|0.48|0.1359
91556435|NCT03371017|183001598|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8225|TWO_SIDED|95.0|0.63|1.43|||Log Rank|||||1.43|0.63|0.8225
91556436|NCT03371017|183001601|SUPERIORITY||Difference in ORR|11.67||||0.0172|TWO_SIDED|95.0|1.47|21.87|||Cochran-Mantel-Haenszel|||||21.87|1.47|0.0172
91556437|NCT03371017|183001602|SUPERIORITY||Difference in ORR|0.18||||0.8679|TWO_SIDED|95.0|-9.41|9.77|||Cochran-Mantel-Haenszel|||Stratified Analysis||9.77|-9.41|0.8679
91556438|NCT03371017|183001603|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2846|TWO_SIDED|95.0|0.46|1.26|||Log Rank|||||1.26|0.46|0.2846
91556439|NCT03371017|183001604|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9853|TWO_SIDED|95.0|0.61|1.61|||Log Rank|||||1.61|0.61|0.9853
91556440|NCT03371017|183001605|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4117|TWO_SIDED|95.0|0.63|1.21|||Log Rank|||Stratified Analysis||1.21|0.63|0.4117
91556441|NCT03371017|183001606|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.7215|TWO_SIDED|95.0|0.68|1.3|||Log Rank|||Stratified Analysis||1.30|0.68|0.7215
91556442|NCT05251363|183001633|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||Ho: SADE-free rate ≤ 87.5% Ha: SADE-free rate \> 87.5% Used an exact binomial test comparing the observed proportion (overall SADE-free rate through 3 months) to the performance goal of 87.5%. The lower, two-sided 95% confidence bound for the overall SADE-free rate must be greater than 87.5% to reject the null hypothesis (Ho), which would demonstrate evidence that the SADE-free rate is significantly higher than 87.5%.||||<0.0001
91556443|NCT05251363|183001634|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||H0: Implant Success Rate ≤ 80% Ha: Implant Success Rate \> 80% Used an exact binomial test comparing the observed proportion (implant success rate) to the performance goal of 80%. The lower, two-sided 95% confidence bound for the overall implant success rate must be greater than 80% to reject the null hypothesis (Ho), which would demonstrate evidence that the rate of successful Solia S LBBA implants is significantly higher than 80.0%.||||< 0.0001
91556444|NCT05251363|183001635|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||H0: Improvement in QOL Physical Function Scale ≤ 2.8 Ha: Improvement in QOL Physical Function Scale \> 2.8 Exact one-sample t-test comparing mean improvement in QOL from baseline to 12-mo post-implant to a goal of +2.8. The lower, two-sided 95% confidence bound for the improvement in QOL must be \> +2.8 to reject H0.||||<0.001
91556445|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.1491|STANDARD_ERROR_OF_MEAN|0.51||0.7695||95.0|-0.856|1.15||Alpha for significance=0.05 for all tests.|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician treatment arm."||1.15|-.856|.7695
91556446|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.5077||0.0878||95.0|-1.88|0.13||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm."||.13|-1.88|.0878
91556447|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.2414|STANDARD_ERROR_OF_MEAN|0.5077||0.635||95.0|-0.76|1.25||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/physician treatment arm."||1.25|-.76|.635
91768407|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-483.2||||0.425|TWO_SIDED|95.0|-1677.87|711.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||711.52|-1677.87|0.425
91768408|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-1025.6||||0.134|TWO_SIDED|95.0|-2373.24|322.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||322.08|-2373.24|0.134
91768409|NCT02365649|183425701|SUPERIORITY||LS Mean Difference|-637.9||||0.293|TWO_SIDED|95.0|-1833.82|557.96||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||557.96|-1833.82|0.293
91768410|NCT02365649|183425702|SUPERIORITY||LS Mean Difference|0.5||||0.921|TWO_SIDED|95.0|-9.02|9.97||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||9.97|-9.02|0.921
91768411|NCT02365649|183425702|SUPERIORITY||LS Mean Difference|-1.6||||0.75|TWO_SIDED|95.0|-11.19|8.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.08|-11.19|0.75
91768412|NCT02365649|183425702|SUPERIORITY||LS Mean Difference|-1.9||||0.7|TWO_SIDED|95.0|-11.7|7.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||7.87|-11.7|0.7
91768413|NCT02365649|183425702|SUPERIORITY||LS Mean Difference|-11.4||||0.024|TWO_SIDED|95.0|-21.38|-1.51||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-1.51|-21.38|0.024
91768414|NCT02365649|183425702|SUPERIORITY||LS Mean Difference|-1.0||||0.845|TWO_SIDED|95.0|-10.72|8.79||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.79|-10.72|0.845
91768415|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|1.7||||0.83|TWO_SIDED|95.0|-13.6|16.92||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||16.92|-13.60|0.830
91768416|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|17.5||||0.027|TWO_SIDED|95.0|2.03|33.0||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||33.00|2.03|0.027
91768417|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|8.9||||0.263|TWO_SIDED|95.0|-6.72|24.47||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.47|-6.72|0.263
91768418|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|21.6||||0.008|TWO_SIDED|95.0|5.68|37.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||37.52|5.68|0.008
91768419|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|8.8||||0.269|TWO_SIDED|95.0|-6.88|24.53||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.53|-6.88|0.269
91768420|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|10.3||||0.231|TWO_SIDED|95.0|-6.63|27.25||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||27.25|-6.63|0.231
91768421|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|27.9||||0.002|TWO_SIDED|95.0|10.68|45.15||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||45.15|10.68|0.002
91768422|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|17.1||||0.057|TWO_SIDED|95.0|-0.51|34.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||34.72|-0.51|0.057
91768423|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|28.8||||0.002|TWO_SIDED|95.0|11.12|46.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||46.56|11.12|0.002
91768424|NCT02365649|183425703|SUPERIORITY||LS Mean Difference|12.3||||0.165|TWO_SIDED|95.0|-5.12|29.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||29.72|-5.12|0.165
91768425|NCT02365649|183425704|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
91768426|NCT02365649|183425704|SUPERIORITY||Adjusted risk difference from placebo|16.7||||0.221|TWO_SIDED|95.0|-10.0|43.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43.3|-10.0|0.221
91768427|NCT02365649|183425704|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.18|TWO_SIDED|95.0|-9.2|49.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.2|-9.2|0.18
91556448|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.06574|STANDARD_ERROR_OF_MEAN|0.5077||0.897||95.0|-1.0709|0.9394||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the older adult treatment arm."||.9394|-1.0709|.897
91556449|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.01126|STANDARD_ERROR_OF_MEAN|0.5077||0.9823||95.0|-1.0164|0.9939||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician/older adult treatment arm."||.9939|-1.0164|.9823
91556450|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.4928|STANDARD_ERROR_OF_MEAN|0.5077||0.3337||95.0|-1.4979|0.5124||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm."||.5124|-1.4979|.3337
91556451|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.2002|STANDARD_ERROR_OF_MEAN|0.5077||0.694||95.0|-0.8049|1.2054||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult/physician treatment arm."||1.2054|-.8049|.694
91556452|NCT04837937|183001667|SUPERIORITY||Actual Intercept value|54.9056|STANDARD_ERROR_OF_MEAN|0.5077|<|0.0001||95.0|53.9003|55.9109||this is the Intercept value for the GLMM evaluating all combinations of treatment and time- in other words, this is the mean well-being t-score across all combinations of tx and time. Estimates in these analyses are deviations from this intercept.|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the intercept (all tx=0).||55.9109|53.9003|<.0001
91768428|NCT02365649|183425704|SUPERIORITY||LS Mean Difference|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
91768429|NCT02365649|183425705|SUPERIORITY||Adjusted risk difference from placebo|5.5||||0.607|TWO_SIDED|95.0|-15.5|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|-15.5|0.607
91768430|NCT02365649|183425705|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.272|TWO_SIDED|95.0|-9.6|33.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.9|-9.6|0.272
91768431|NCT02365649|183425705|SUPERIORITY||Adjusted risk difference from placebo|15.9||||-0.157|TWO_SIDED|95.0|-6.1|37.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.9|-6.1|-0.157
91768432|NCT02365649|183425705|SUPERIORITY||LS Mean Difference|27.7||||0.017|TWO_SIDED|95.0|4.9|50.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.6|4.9|0.017
91768433|NCT02365649|183425705|SUPERIORITY||Adjusted risk difference from placebo|2.8||||0.798|TWO_SIDED|95.0|-18.4|23.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||23.9|-18.4|0.798
91768434|NCT02365649|183425706|SUPERIORITY||Adjusted risk difference from placebo|9.8||||0.119|TWO_SIDED|95.0|-2.5|22.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.1|-2.5|0.119
91768435|NCT02365649|183425706|SUPERIORITY||Adjusted risk difference from placebo|15.4||||0.034|TWO_SIDED|95.0|1.1|29.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.7|1.1|0.034
91768436|NCT02365649|183425706|SUPERIORITY||Adjusted risk difference from placebo|23.2||||0.004|TWO_SIDED|95.0|7.3|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|7.3|0.004
91768437|NCT02365649|183425706|SUPERIORITY||Adjusted risk difference from placebo|32.4|||<|0.001|TWO_SIDED|95.0|14.2|50.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.5|14.2|< 0.001
91768438|NCT02365649|183425706|SUPERIORITY||Adjusted risk difference from placebo|22.9|||<|0.006|TWO_SIDED|95.0|6.6|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|6.6|< 0.006
91768439|NCT02365649|183425707|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.647|TWO_SIDED|95.0|-12.7|20.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.5|-12.7|0.647
91768440|NCT02365649|183425707|SUPERIORITY||Adjusted risk difference from placebo|17.1||||0.093|TWO_SIDED|95.0|-2.9|37.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.1|-2.9|0.093
91768441|NCT02365649|183425707|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.165|TWO_SIDED|95.0|-5.6|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-5.6|0.165
91768442|NCT02365649|183425707|SUPERIORITY||Adjusted risk difference from placebo|24.9||||0.023|TWO_SIDED|95.0|3.4|46.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||46.3|3.4|0.023
91768443|NCT02365649|183425707|SUPERIORITY||Adjusted risk difference from placebo|7.0||||0.448|TWO_SIDED|95.0|-11.0|25.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.0|-11.0|0.448
91556453|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.05579|STANDARD_ERROR_OF_MEAN|0.03516||0.1152||95.0|-0.1254|0.01383||alpha=0.05|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This test evaluates the effect of time (measured as weeks since baseline).||.01383|-.1254|.1152
91556454|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.03261|STANDARD_ERROR_OF_MEAN|0.03516||0.3555||95.0|-0.1022|0.03699|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician treatment arm\*time."||.03699|-.1022|.3555
91556455|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.06825|STANDARD_ERROR_OF_MEAN|0.03516||0.0546||95.0|-0.00136|0.1379||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm\*time."||.1379|-.00136|.0546
91556456|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.02597|STANDARD_ERROR_OF_MEAN|0.03516||0.4616||95.0|-0.04364|0.09557||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Physician treatment arm\*time."||.09557|-.04364|.4616
91556457|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.0498|STANDARD_ERROR_OF_MEAN|0.03516||0.1592||95.0|-0.0198|0.1194||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Older Adult treatment arm\*time."||.1194|-.0198|.1592
91556458|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.02435|STANDARD_ERROR_OF_MEAN|0.03516||0.4899||95.0|-0.09396|0.04526|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician/Older Adult treatment arm\*time."||.04526|-.09396|.4899
91556459|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|0.000697|STANDARD_ERROR_OF_MEAN|0.03516||0.9842||95.0|-0.06891|0.0703||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm\*time."||.0703|-.06891|.9842
91556460|NCT04837937|183001667|SUPERIORITY||Mean Difference (Final Values)|-0.01255|STANDARD_ERROR_OF_MEAN|0.03516||0.7217||95.0|-0.08216|0.05705||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Older Adult/Physician treatment arm\*time."||.05705|-.08216|.7217
91556461|NCT04837937|183001668|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_DEVIATION|6.55||0.21||95.0|-1.9|0.42||Threshold for statistical significance was alpha=0.05.|2-sided paired t-Test|||Univariate ANOVA- analytic variable is change in PROMIS Anxiety score from baseline to T3. Test is a paired T-Test.||.42|-1.90|.21
91556462|NCT04837937|183001669|SUPERIORITY||Mean Difference (Final Values)|-3.24|STANDARD_DEVIATION|11.54||0.0021||95.0|-5.28|-1.2||Threshold for significance was 0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in Zarit Caregiver Burden Score, Baseline to 1-month post-intervention. Test was a 2-sided dependent samples t-test.||-1.20|-5.28|.0021
91556463|NCT04837937|183001670|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|8.1||0.1||95.0|-2.62|0.25||Alpha for statistical significance was 0.05|2-Sided Paired T Test|||Univariate ANOVA- analytic variable is change in PROMIS Fatigue score from baseline to T3. Test is a paired T-Test.||.25|-2.62|.10
91556464|NCT04837937|183001671|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|7.83||0.9754||95.0|-1.36|1.41|||2-sided paired (dependent sample) t-test|||Univariate ANOVA on change in PROMIS short form General Self Efficacy T-Score, baseline to one month post-intervention. Test is a 2-sided paired (dependent sample) t-test.||1.41|-1.36|.9754
91556465|NCT04837937|183001673|SUPERIORITY||Mean Difference (Final Values)|0.1296|STANDARD_DEVIATION|4.91||0.77||95.0|-0.74|1.0||Threshold for significance is 0.05|2-sided Paired T-Test|||Univariate ANOVA on change in T-Score between baseline and 1 month post-intervention. Test is a 2-sided paired t-test.||1.00|-.74|.77
91556466|NCT04837937|183001674|SUPERIORITY||Mean Difference (Final Values)|0.7618|STANDARD_DEVIATION|6.16||0.1694||95.0|-0.33|1.85||alpha threshold for significance was 0.05.|two-sided paired T-Test|||Univariate ANOVA on change in T-score between baseline and one month post-intervention. Test is a two-sided paired t-test.||1.85|-.33|.1694
91556467|NCT04837937|183001679|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|16.44||0.76||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Avoiding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.76
91556468|NCT04837937|183001679|SUPERIORITY||Mean Difference (Final Values)|2.25|STANDARD_DEVIATION|16.33||0.13||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.13
91556469|NCT04837937|183001679|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_DEVIATION|18.76|<|0.0001||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention.||||<.0001
91556470|NCT04837937|183001679|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|15.62||0.86||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.86
91556471|NCT04837937|183001679|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|12.3||0.32||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.32
91556472|NCT04837937|183001680|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_DEVIATION|13.18||0.0012||95.0|||||ANOVA|||Univariate ANOVA on change in total Negotiation Knowledge score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0012
91768444|NCT02365649|183425708|SUPERIORITY||LS Mean Difference|0.4||||0.412|TWO_SIDED|95.0|-0.62|1.5||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.5|-0.62|0.412
91768445|NCT02365649|183425708|SUPERIORITY||LS Mean Difference|-1.4||||0.01|TWO_SIDED|95.0|-2.47|-0.34||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.34|-2.47|0.01
91556473|NCT04837937|183001680|SUPERIORITY||Mean Difference (Final Values)|4.933|STANDARD_DEVIATION|17.33||0.0018||||||alpha=0.05|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0018
91556474|NCT04837937|183001680|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|19.69||0.91||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month.||||.91
91556475|NCT04837937|183001680|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_DEVIATION|22.35||0.11||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month.||||.11
91556476|NCT04837937|183001682|SUPERIORITY||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|5.73|<|0.0001||95.0|-3.09|-1.07||Threshold for significance is alpha=0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in negative affect score, baseline-1 month post-intervention. Test is a 2 sided dependent sample t-test.||-1.07|-3.09|<.0001
91556477|NCT04837937|183001682|SUPERIORITY||Mean Difference (Final Values)|0.344|STANDARD_DEVIATION|4.86||0.4305||95.0|-0.52|1.21|||2-sided dependent sample t-test|||Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test.||1.21|-.52|.4305
91556478|NCT06072170|183001687|OTHER|Proportionality analysis was done using a power model.|Slope|0.829|||||TWO_SIDED|90.0|0.659|0.998||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.998|0.659|
91556479|NCT06072170|183001687|OTHER|Proportionality analysis was done using a power model.|Slope|0.843|||||TWO_SIDED|90.0|0.713|0.973||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.973|0.713|
91556480|NCT06072170|183001687|OTHER|Proportionality analysis was done using a power model.|Slope|0.811|||||TWO_SIDED|90.0|0.637|0.984||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.984|0.637|
91556481|NCT06072170|183001687|OTHER|Proportionality analysis was done using a power model.|Slope|0.814|||||TWO_SIDED|90.0|0.633|0.994||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.994|0.633|
91556482|NCT06072170|183001687|OTHER|Proportionality analysis was done using a power model.|Slope|0.88|||||TWO_SIDED|90.0|0.72|1.039||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.039|0.720|
91768446|NCT02365649|183425708|SUPERIORITY||LS Mean Difference|-1.0||||0.082|TWO_SIDED|95.0|-2.13|0.13||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.13|-2.13|0.082
91556483|NCT06072170|183001689|OTHER|Proportionality analysis was done using a power model.|Slope|0.946|||||TWO_SIDED|90.0|0.768|1.123||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.123|0.768|
91556484|NCT06072170|183001689|OTHER|Proportionality analysis was done using a power model.|Slope|0.978|||||TWO_SIDED|90.0|0.821|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.821|
91556485|NCT06072170|183001689|OTHER|Proportionality analysis was done using a power model.|Slope|1.075|||||TWO_SIDED|90.0|0.901|1.249||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.249|0.901|
91556486|NCT06072170|183001689|OTHER|Proportionality analysis was done using a power model.|Slope|1.046|||||TWO_SIDED|90.0|0.87|1.222||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.222|0.870|
91556487|NCT06072170|183001689|OTHER|Proportionality analysis was done using a power model.|Slope|1.011|||||TWO_SIDED|90.0|0.844|1.178||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.178|0.844|
91556488|NCT06072170|183001690|OTHER|Proportionality analysis was done using a power model.|Slope|0.959|||||TWO_SIDED|90.0|0.775|1.143||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.143|0.775|
91556489|NCT06072170|183001690|OTHER|Proportionality analysis was done using a power model.|Slope|0.974|||||TWO_SIDED|90.0|0.815|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.815|
91556490|NCT06072170|183001690|OTHER|Proportionality analysis was done using a power model.|Slope|1.036|||||TWO_SIDED|90.0|0.866|1.207||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.207|0.866|
91556491|NCT06072170|183001690|OTHER|Proportionality analysis was done using a power model.|Slope|0.967|||||TWO_SIDED|90.0|0.79|1.145||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.145|0.790|
91556492|NCT06072170|183001690|OTHER|Proportionality analysis was done using a power model.|Slope|1.025|||||TWO_SIDED|90.0|0.859|1.191||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.191|0.859|
91556493|NCT06072170|183001694|SUPERIORITY||Least-Square Mean|18.5|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|6.16|30.78||||||||30.78|6.16|
91556494|NCT06072170|183001697|SUPERIORITY||Least-Squared Mean|45.9|STANDARD_ERROR_OF_MEAN|7.74|<|0.001|TWO_SIDED|95.0|30.2|61.67|||ANOVA|||Statistical Analysis for High Visual Analog Scale (Emax)||61.67|30.20|<0.001
91556495|NCT03070392|183001698|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Log Rank|||||0.71|0.37|<0.0001
91556496|NCT03070392|183001700|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0139|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.0139
91556497|NCT03861052|183001716|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.27|-0.9|||Mixed Models Analysis|||||-0.90|-1.27|<0.001
91556498|NCT03861052|183001716|SUPERIORITY||Least Squares Mean Difference|-1.27|||<|0.001|TWO_SIDED|95.0|-1.45|-1.08|||Mixed Models Analysis|||||-1.08|-1.45|<0.001
91556499|NCT03861052|183001716|SUPERIORITY||Least Squares Mean Difference|-1.53|||<|0.001|TWO_SIDED|95.0|-1.71|-1.35|||Mixed Models Analysis|||||-1.35|-1.71|<0.001
91556500|NCT03861052|183001717|SUPERIORITY||Odds Ratio (OR)|9.89|||<|0.001|TWO_SIDED|95.0|4.53|21.55|||Regression, Logistic|||||21.55|4.53|<0.001
91556501|NCT03861052|183001717|SUPERIORITY||Odds Ratio (OR)|20.57|||<|0.001|TWO_SIDED|95.0|7.73|54.71|||Regression, Logistic|||||54.71|7.73|<0.001
91556502|NCT03861052|183001717|SUPERIORITY||Odds Ratio (OR)|85.31|||<|0.001|TWO_SIDED|95.0|15.8|460.58|||Regression, Logistic|||||460.58|15.80|<0.001
91556503|NCT03861052|183001718|SUPERIORITY||Least Squares Mean Difference|-25.9|||<|0.001|TWO_SIDED|95.0|-30.7|-21.1|||Mixed Models Analysis|||||-21.1|-30.7|<0.001
91556504|NCT03861052|183001718|SUPERIORITY||Least Squares Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-37.5|-27.8|||Mixed Models Analysis|||||-27.8|-37.5|<0.001
91556505|NCT03861052|183001718|SUPERIORITY||Least Squares Mean Difference|-35.7|||<|0.001|TWO_SIDED|95.0|-40.6|30.9|||Mixed Models Analysis|||||30.9|-40.6|<0.001
91556506|NCT03861052|183001719|SUPERIORITY||Least Squares Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-21.4|-13.2|||ANCOVA|||||-13.2|-21.4|<0.001
91556507|NCT03861052|183001719|SUPERIORITY||Least Squares Mean Difference|-22.0|||<|0.001|TWO_SIDED|95.0|-26.1|-17.9|||ANCOVA|||||-17.9|-26.1|<0.001
91556508|NCT03861052|183001719|SUPERIORITY||Least Squares Mean Difference|-26.4|||<|0.001|TWO_SIDED|95.0|-30.5|-22.2|||ANCOVA|||||-22.2|-30.5|<0.001
91556509|NCT03861052|183001720|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.4|-4.1|||Mixed Models Analysis|||||-4.1|-6.4|<0.001
91556510|NCT03861052|183001720|SUPERIORITY||Least Squares Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.1|-6.8|||Mixed Models Analysis|||||-6.8|-9.1|<0.001
91556511|NCT03861052|183001720|SUPERIORITY||Least Squares Mean Difference|-10.1|||<|0.001|TWO_SIDED|95.0|-11.3|-9.0|||Mixed Models Analysis|||||-9.0|-11.3|<0.001
91556512|NCT03861052|183001721|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.001|TWO_SIDED|95.0|7.88|26.46|||Regression, Logistic|||||26.46|7.88|<0.001
91556513|NCT03861052|183001721|SUPERIORITY||Odds Ratio (OR)|44.96|||<|0.001|TWO_SIDED|95.0|23.12|87.45|||Regression, Logistic|||||87.45|23.12|<0.001
91556514|NCT03861052|183001721|SUPERIORITY||Odds Ratio (OR)|82.67|||<|0.001|TWO_SIDED|95.0|39.84|171.52|||Regression, Logistic|||||171.52|39.84|<0.001
91556515|NCT03861052|183001722|SUPERIORITY||Least Squares Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.67|-1.28|||Mixed Models Analysis|||||-1.28|-3.67|<0.001
91556516|NCT03861052|183001722|SUPERIORITY||Least Squares Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|0.592|<|0.001|TWO_SIDED|95.0|-4.43|-2.11|||Mixed Models Analysis|||||-2.11|-4.43|<0.001
91556517|NCT03861052|183001722|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-4.55|-2.25|||Mixed Models Analysis|||||-2.25|-4.55|<0.001
91556518|NCT03861052|183001723|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|<0.001
91556519|NCT03861052|183001723|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||Mixed Models Analysis|||||-0.27|-0.53|<0.001
91556520|NCT03861052|183001723|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Models Analysis|||||-0.25|-0.51|<0.001
91556521|NCT03861052|183001724|SUPERIORITY||Least Squares Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|10.7|21.4|||Mixed Models Analysis|||||21.4|10.7|<0.001
91556522|NCT03861052|183001724|SUPERIORITY||Least Squares Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|14.9|26.3|||Mixed Models Analysis|||||26.3|14.9|<0.001
91556523|NCT03861052|183001724|SUPERIORITY||Least Squares Mean Difference|23.9|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|18.1|29.7|||Mixed Models Analysis|||||29.7|18.1|<0.001
91556524|NCT03861052|183001725|SUPERIORITY||Least Squares Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|11.7|28.2|||Mixed Models Analysis|||||28.2|11.7|<0.001
91556525|NCT03861052|183001725|SUPERIORITY||Least Squares Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|18.0|36.0|||Mixed Models Analysis|||||36.0|18.0|<0.001
91556526|NCT03861052|183001725|SUPERIORITY||Least Squares Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|4.68|<|0.001|TWO_SIDED|95.0|22.0|40.4|||Mixed Models Analysis|||||40.4|22.0|<0.001
91556527|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.485|0.939|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.939|0.485|
91556528|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.467|0.911|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.911|0.467|
91556529|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.517|1.051|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||1.051|0.517|
91556530|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.497|1.02|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||1.020|0.497|
91556531|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.567|0.973|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.973|0.567|
91556532|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.547|0.943|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.943|0.547|
91556533|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.353|0.896|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.896|0.353|
91556534|NCT03678688|183001754|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.338|0.871|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.871|0.338|
91556535|NCT03678688|183001794|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.626|3.175|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||3.175|0.626|
91556536|NCT03678688|183001794|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.362|2.151|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.151|0.362|
91556537|NCT03678688|183001794|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.736|2.656|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||2.656|0.736|
91556538|NCT03678688|183001794|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.564|2.206|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.206|0.564|
91556539|NCT02949297|183001844|OTHER|One-sided Clopper-Pearson 95% confidence interval|Clopper-Pearson|80.0|||||ONE_SIDED|95.0||95.0|||||One-sided Clopper-Pearson 95% confidence interval|||95||
91556540|NCT00458783|183001859|SUPERIORITY||Odds Ratio (OR)|0.77||||0.08|TWO_SIDED|95.0|0.5|1.2|||generalized estimating equation (GEE)|Generalized estimating equation (GEE) distinct-effects model||||1.2|0.50|0.08
91556541|NCT00458783|183001860|SUPERIORITY||Odds Ratio, log|0.64|||||TWO_SIDED|95.0|0.25|1.6||||||||1.6|0.25|
91556542|NCT00458783|183001861|SUPERIORITY||Odds Ratio, log|0.72|||||TWO_SIDED|95.0|0.26|2.0||||||||2.0|0.26|
91556543|NCT00458783|183001862|SUPERIORITY||Odds Ratio, log|0.9|||||TWO_SIDED|95.0|0.59|1.4||||||||1.4|0.59|
91556544|NCT00458783|183001863|SUPERIORITY||Odds Ratio, log|0.86|||||TWO_SIDED|95.0|0.43|1.8||||||||1.8|0.43|
91556545|NCT00458783|183001864|SUPERIORITY||Risk Ratio, log|0.81|||||TWO_SIDED|95.0|0.24|2.8||||||||2.8|0.24|
91556546|NCT00458783|183001865|SUPERIORITY||Odds Ratio, log|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||||1.5|0.80|
91556547|NCT00458783|183001866|SUPERIORITY||Odds Ratio, log|0.43|||||TWO_SIDED|95.0|0.16|1.1||||||||1.1|0.16|
91556548|NCT00458783|183001867|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.39|1.7||||||||1.7|0.39|
91556549|NCT00458783|183001868|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.5|1.3||||||||1.3|0.50|
91556550|NCT00458783|183001869|SUPERIORITY||Odds Ratio, log|0.76|||||TWO_SIDED|95.0|0.18|3.2||||||||3.2|0.18|
91556551|NCT00458783|183001870|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox||The 95%CI is interim adjusted.|||1.29|0.94|0.9
91556552|NCT00458783|183001871|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.07|TWO_SIDED|95.0|0.85|1.18|||Regression, Cox||The 95%CI is interim adjusted.|||1.18|0.85|0.07
91556553|NCT01737398|183001872|OTHER||Least Square Mean Difference|-19.73||||4e-08|TWO_SIDED|95.0|-26.43|-13.03|||MMRM|||||-13.03|-26.43|0.00000004
91556554|NCT01737398|183001873|OTHER||Least Square Mean Difference|-11.68||||0.0006|TWO_SIDED|95.0|-18.29|-5.06|||MMRM|||||-5.06|-18.29|0.0006
91556555|NCT00089609|183001898|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
91556556|NCT00357994|183001902|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
91556557|NCT00357994|183001903|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
91768447|NCT02365649|183425708|SUPERIORITY||LS Mean Difference|-1.6||||0.004|TWO_SIDED|95.0|-2.73|-0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.52|-2.73|0.004
91556558|NCT00357994|183001904|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
91556559|NCT00357994|183001905|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
91556560|NCT00357994|183001906|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
91556561|NCT00357994|183001907|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
91556562|NCT00357994|183001908|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
91556563|NCT00357994|183001909|SUPERIORITY_OR_OTHER||Treament Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
91556564|NCT00357994|183001910|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
91556565|NCT00357994|183001911|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
91556566|NCT00357994|183001912|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
91556567|NCT00357994|183001913|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
91768448|NCT02365649|183425708|SUPERIORITY||LS Mean Difference|0.2||||0.766|TWO_SIDED|95.0|-0.93|1.26||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.26|-0.93|0.766
91556568|NCT00357994|183001914|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
91556569|NCT00357994|183001915|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
91556570|NCT00357994|183001916|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
91556571|NCT00357994|183001917|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
91556572|NCT00357994|183001918|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
91768449|NCT02365649|183425709|SUPERIORITY||LS Mean Difference|-0.6||||0.314|TWO_SIDED|95.0|-1.75|0.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.56|-1.75|0.314
91556573|NCT00357994|183001919|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
91556574|NCT00357994|183001920|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
91556575|NCT00357994|183001921|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
91556576|NCT00357994|183001922|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
91556577|NCT00357994|183001923|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
91556578|NCT01354444|183001926|OTHER||Coefficient|1.48||||0.565|TWO_SIDED|95.0|-3.796|6.761|||Regression, Linear|||This analysis compares immediate recall before and after 6 months between the treatment and placebo group.||6.761|-3.796|0.565
91556579|NCT01354444|183001927|OTHER|||||||0.481|||||||Rank sum test|||This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.||||0.481
91556580|NCT01354444|183001927|OTHER|||||||0.0562|||||||Rank sum test|||This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.||||0.0562
91556581|NCT01354444|183001927|OTHER|||||||0.314|||||||Rank sum test|||This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.||||0.314
91556582|NCT01354444|183001927|OTHER|||||||0.438|||||||Rank sum test|||This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.||||0.438
91556583|NCT00982072|183001929|OTHER|||||||0.12|||||||Fisher Exact|||||||0.12
91768450|NCT02365649|183425709|SUPERIORITY||LS Mean Difference|-1.8||||0.002|TWO_SIDED|95.0|-3.01|-0.68||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.68|-3.01|0.002
91556584|NCT03559205|183001936|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.74|0.7|||t-test, 2 sided|||2 Week Analysis||0.70|-0.74|0.96
91556585|NCT03559205|183001937|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.9|TWO_SIDED|95.0|-2.31|2.04|||t-test, 2 sided|||Baseline||2.04|-2.31|0.90
91556586|NCT03559205|183001937|SUPERIORITY||Mean Difference (Final Values)|2.01||||0.21|TWO_SIDED|95.0|-1.17|5.19|||t-test, 2 sided|||2 Week Analysis||5.19|-1.17|0.21
91556587|NCT03559205|183001937|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.63|TWO_SIDED|95.0|-2.95|4.83|||t-test, 2 sided|||3-Month||4.83|-2.95|0.63
91556588|NCT03559205|183001938|SUPERIORITY||Mean Difference (Final Values)|2.63||||0.15|TWO_SIDED|95.0|-1.0|6.26|||t-test, 2 sided|||Baseline||6.26|-1.00|0.15
91556589|NCT03559205|183001938|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3|TWO_SIDED|95.0|-2.02|6.45|||t-test, 2 sided|||Week 2 analysis||6.45|-2.02|0.30
91556590|NCT03559205|183001938|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.85|TWO_SIDED|95.0|-4.89|5.9|||t-test, 2 sided|||3-Month||5.90|-4.89|0.85
91556591|NCT03559205|183001939|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.72|TWO_SIDED|95.0|-0.51|0.74|||t-test, 2 sided|||Care and respect||0.74|-0.51|0.72
91556592|NCT03559205|183001939|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.46|TWO_SIDED|95.0|-0.38|0.83|||t-test, 2 sided|||Understanding \& engagement||0.83|-0.38|0.46
91556593|NCT03559205|183001940|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3|TWO_SIDED|95.0|-0.13|0.42|||t-test, 2 sided|||2-weeks||0.42|-0.13|0.30
91556594|NCT03559205|183001940|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.38|TWO_SIDED|95.0|-0.2|0.52|||t-test, 2 sided|||3-months||0.52|-0.20|0.38
91556595|NCT03559205|183001941|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.48|0.88|||t-test, 2 sided|||||0.88|-1.48|0.61
91556596|NCT00047385|183001954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.733|0.932||P-value is adjusted for multiple comparisons.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||"Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.~Power: 90% for a 20% reduction in lung cancer mortality."||0.932|0.733|0.004
91556597|NCT00047385|183001955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.02|TWO_SIDED|95.0|0.864|0.988||No adjustment for multiple comparisons. Only one analysis performed.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.||0.988|0.864|0.02
91556598|NCT00047385|183001956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.03|1.23|||||Denominator: LDCT Group Numerator: CXR Group|||1.23|1.03|
91556599|NCT02095145|183001984|OTHER|||||||0.19|||||||Wilcoxon rank-sum test|||||||0.190
91556600|NCT02095145|183001984|OTHER|||||||0.211|||||||t-test, 2 sided|||||||0.211
91556601|NCT02095145|183001987|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.948
91556602|NCT02095145|183001987|OTHER|||||||0.711|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.711
91768451|NCT02365649|183425709|SUPERIORITY||LS Mean Difference|-0.7||||0.255|TWO_SIDED|95.0|-1.94|0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.52|-1.94|0.255
91556603|NCT02095145|183001987|OTHER|||||||0.038|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.038
91556604|NCT02095145|183001987|OTHER|||||||0.445|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.445
91556605|NCT02095145|183001988|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.743
91556606|NCT02095145|183001988|OTHER|||||||0.305|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.305
91556607|NCT02095145|183001988|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.111
91556608|NCT02095145|183001988|OTHER|||||||0.395|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.395
91556609|NCT02095145|183001989|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 13||||0.743
91556610|NCT02095145|183001989|OTHER|||||||0.527|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 26||||0.527
91556611|NCT02095145|183001989|OTHER|||||||0.879|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 39||||0.879
91556612|NCT02095145|183001989|OTHER|||||||0.81|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 52||||0.810
91556613|NCT02095145|183001990|OTHER|||||||0.556|||||||Wilcoxon rank-sum test|||Comparison of both arms at baseline||||0.556
91556614|NCT02095145|183001990|OTHER|||||||0.647|||||||Wilcoxon rank-sum test|||comparison of both arms at Week 26||||0.647
91556615|NCT02095145|183001990|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||comparison of both arms at end of study, week 52||||0.948
91556616|NCT02095145|183001991|OTHER|||||||0.58|||||||Wilcoxon rank-sum test|||||||0.580
91556617|NCT02095145|183001992|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Benign core p-value||||0.344
91556618|NCT02095145|183001992|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Adjacent core p-value||||0.371
91556619|NCT02095145|183001992|OTHER|||||||0.766|||||||Wilcoxon rank-sum test|||Tumor core p-value||||0.766
91556620|NCT02095145|183001993|OTHER|||||||0.304|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Nuc)||||0.304
91556621|NCT02095145|183001993|OTHER|||||||0.23|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Nuc)||||0.230
91556622|NCT02095145|183001993|OTHER|||||||0.298|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Nuc)||||0.298
91556623|NCT02095145|183001993|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cyt)||||0.247
91556624|NCT02095145|183001993|OTHER|||||||0.093|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cyt)||||0.093
91556625|NCT02095145|183001993|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cyt)||||0.066
91556626|NCT02095145|183001993|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cell)||||0.247
91556627|NCT02095145|183001993|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cell)||||0.128
91556628|NCT02095145|183001993|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cell)||||0.128
91556629|NCT02095145|183001994|OTHER|||||||0.297|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.297
91556630|NCT02095145|183001994|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.233
91556631|NCT02095145|183001994|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.371
91556632|NCT02095145|183001994|OTHER|||||||0.198|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.198
91556633|NCT02095145|183001994|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.233
91556634|NCT02095145|183001994|OTHER|||||||0.074|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.074
91556635|NCT02095145|183001994|OTHER|||||||0.234|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.234
91556636|NCT02095145|183001994|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.233
91556637|NCT02095145|183001994|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.233
91556638|NCT02095145|183001995|OTHER|||||||0.167|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.167
91556639|NCT02095145|183001995|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.391
91556640|NCT02095145|183001995|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.713
91556641|NCT02095145|183001995|OTHER|||||||0.452|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.452
91556642|NCT02095145|183001995|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.391
91556643|NCT02095145|183001995|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.713
91556644|NCT02095145|183001995|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.344
91556645|NCT02095145|183001995|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.391
91556646|NCT02095145|183001995|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.713
91556647|NCT02095145|183001996|OTHER|||||||0.865|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.865
91556648|NCT02095145|183001996|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||1.000
91556649|NCT02095145|183001996|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.066
91556650|NCT02095145|183001997|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Benign p-value||||1.000
91556651|NCT02095145|183001997|OTHER|||||||0.903|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Adjacent p-value||||0.903
91556652|NCT02095145|183001997|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Tumor p-value||||1.000
91556653|NCT02095145|183001997|OTHER|||||||0.269|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Benign p-value||||0.269
91556654|NCT02095145|183001997|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Adjacent p-value||||0.066
91556655|NCT02095145|183001997|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Tumor p-value||||1.000
91556656|NCT02095145|183001997|OTHER|||||||0.425|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Benign p-value||||0.425
91556657|NCT02095145|183001997|OTHER|||||||0.27|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Adjacent p-value||||0.270
91556658|NCT02095145|183001997|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Tumor p-value||||1.000
91556659|NCT02095145|183001998|OTHER|||||||0.625|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.625
91556660|NCT02095145|183001998|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.128
91556661|NCT02095145|183001998|OTHER|||||||0.045|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.045
91556662|NCT02095145|183001998|OTHER|||||||0.105|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.105
91556663|NCT02095145|183001998|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.066
91556664|NCT02095145|183001998|OTHER|||||||0.005|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.005
91556665|NCT02095145|183001998|OTHER|||||||0.129|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.129
91556666|NCT02095145|183001998|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.066
91556667|NCT02095145|183001998|OTHER|||||||0.013|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.013
91556668|NCT02095145|183001999|OTHER|||||||0.143|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.143
91556669|NCT02095145|183001999|OTHER|||||||0.037|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||0.037
91556670|NCT02095145|183001999|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.111
91556671|NCT02095145|183002000|OTHER|||||||0.068|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||0.068
91556672|NCT02095145|183002000|OTHER|||||||0.004|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.004
91556673|NCT02095145|183002000|OTHER|||||||0.002|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.002
91556674|NCT02095145|183002000|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||<0.001
91556675|NCT02095145|183002001|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||1.000
91556676|NCT02095145|183002001|OTHER|||||||0.18|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.180
91556677|NCT02095145|183002001|OTHER|||||||0.62|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.620
91556678|NCT02095145|183002001|OTHER|||||||0.536|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||0.536
91556679|NCT02095145|183002003|OTHER|||||||0.231|||||||Wilcoxon rank-sum test|||Change in Tumor Volume from baseline to end of study per arm||||0.231
91556680|NCT00853580|183002031|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
91556681|NCT00853580|183002032|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
91556682|NCT00853580|183002033|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
91556683|NCT00853580|183002034|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
91556684|NCT00853580|183002035|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
91556685|NCT00853580|183002036|SUPERIORITY|||||||0.99|||||||ANCOVA|||||||0.99
91556686|NCT00853580|183002037|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||0.90
91556687|NCT00853580|183002038|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
91556688|NCT00853580|183002039|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
91556689|NCT00853580|183002040|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
91556690|NCT00853580|183002041|SUPERIORITY|||||||0.09|||||||ANCOVA|||||||0.09
91556691|NCT00853580|183002042|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
91556692|NCT00853580|183002043|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
91556693|NCT00853580|183002044|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
91556694|NCT00853580|183002045|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
91556695|NCT00853580|183002046|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
91556696|NCT00853580|183002047|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
91556697|NCT00853580|183002048|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
91556698|NCT00853580|183002049|SUPERIORITY|||||||0.3|||||||ANCOVA|||||||0.30
91556699|NCT00853580|183002050|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
91556700|NCT01767467|183002052|NON_INFERIORITY|The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (\>) 3.|Adjusted Geometric Mean Concentration|29.75|||<|0.0001|TWO_SIDED|95.0|21.09|41.96||The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1|Repeated measurement model|||The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.||41.96|21.09|<0.0001
91556701|NCT01335867|183002071|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||.14
91556702|NCT01335867|183002073|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||.24
91556703|NCT01335867|183002074|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||.20
91556704|NCT01335867|183002075|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||.64
91556705|NCT00176202|183002084|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
91556706|NCT00176202|183002084|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
91556707|NCT00176202|183002085|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<.01
91556708|NCT00176202|183002085|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||||||0.01
91556709|NCT00176202|183002086|SUPERIORITY_OR_OTHER||effect size|-1.59|||<|0.01|TWO_SIDED|||||In case of both risperidone and divalproex sodium.|Chi-squared|||||||<0.01
91556710|NCT00176202|183002086|SUPERIORITY_OR_OTHER||Effect size|-1.33|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
91556711|NCT00176202|183002087|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||baseline is compared to LOCF to determine the p value.||||<0.01
91556712|NCT00176202|183002087|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
91556713|NCT04119063|183002127|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.204|||||||t-test, 2 sided|||||||0.204
91556714|NCT04119063|183002128|OTHER|Paired t-test||||||0.049|||||||t-test, 2 sided|||||||0.049
91556715|NCT04119063|183002129|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.039|||||||t-test, 2 sided|||||||0.039
91556716|NCT04119063|183002130|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.242|||||||t-test, 2 sided|||||||0.242
91556717|NCT04119063|183002131|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.014|||||||t-test, 2 sided|||||||.014
91556718|NCT03102034|183002184|OTHER||% vaccine recipients with solicited AEs|76.0|||||TWO_SIDED|90.0|56.0|90.0|||||Confidence intervals were Exact Clopper-Pearson.|||90|56|
91768452|NCT02365649|183425709|SUPERIORITY||LS Mean Difference|-1.4||||0.022|TWO_SIDED|95.0|-2.61|-0.2||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.2|-2.61|0.022
91768453|NCT02365649|183425709|SUPERIORITY||LS Mean Difference|-0.7||||0.239|TWO_SIDED|95.0|-1.92|0.48||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.48|-1.92|0.239
91556719|NCT03102034|183002184|OTHER||% placebo recipients with solicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0|||||Confidence intervals were Exact Clopper-Pearson.|||47|3|
91556720|NCT03102034|183002185|OTHER||% vaccinees with unsolicited AEs|24.0|||||TWO_SIDED|90.0|10.0|44.0|||||Confidence intervals were Exact Clopper-Pearson.|||44|10|
91556721|NCT03102034|183002185|OTHER||% placebo with unsolicited AEs|9.0|||||TWO_SIDED|90.0|0.0|36.0|||||Confidence intervals were Exact Clopper-Pearson.|||36|0|
91556722|NCT03102034|183002190|SUPERIORITY||||||<|0.001||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.001
91556723|NCT03102034|183002191|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
91556724|NCT00145470|183002196|SUPERIORITY|||||||0.0257||||||P-value based on the difference in the least squares (LS) means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0257
91556725|NCT00145470|183002199|SUPERIORITY|||||||0.021||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 42||||0.0210
91556726|NCT00145470|183002200|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0073
91556727|NCT00145470|183002201|SUPERIORITY|||||||0.3928|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3928
91556728|NCT00145470|183002201|SUPERIORITY|||||||0.7923|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.7923
91556729|NCT00145470|183002201|SUPERIORITY|||||||0.0701|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.0701
91556730|NCT00145470|183002201|SUPERIORITY|||||||0.1634|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.1634
91556731|NCT00145470|183002201|SUPERIORITY|||||||0.037|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0370
91556732|NCT00145470|183002201|SUPERIORITY|||||||0.0488|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0488
91556733|NCT00145470|183002201|SUPERIORITY|||||||0.0152|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0152
91556734|NCT00145470|183002202|SUPERIORITY|||||||0.3709|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3709
91556735|NCT00145470|183002202|SUPERIORITY|||||||0.8837|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.8837
91556736|NCT00145470|183002202|SUPERIORITY|||||||0.1153|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.1153
91556737|NCT00145470|183002202|SUPERIORITY|||||||0.0158|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.0158
91556738|NCT00145470|183002202|SUPERIORITY|||||||0.0143|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0143
91556739|NCT00145470|183002202|SUPERIORITY|||||||0.0196|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0196
91556740|NCT00145470|183002202|SUPERIORITY|||||||0.0148|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0148
91556741|NCT00145470|183002203|SUPERIORITY|||||||0.0046||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0046
91556742|NCT00145470|183002204|SUPERIORITY|||||||0.0006||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0006
91556743|NCT00145470|183002205|SUPERIORITY|||||||0.3497||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3497
91556744|NCT00145470|183002206|SUPERIORITY|||||||0.7753||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.7753
91556745|NCT00145470|183002207|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0073
91556746|NCT00145470|183002208|SUPERIORITY|||||||0.0102||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0102
91556747|NCT00145470|183002209|SUPERIORITY|||||||0.3684||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3684
91556748|NCT00145470|183002210|SUPERIORITY|||||||0.937||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9370
91556749|NCT00145470|183002211|SUPERIORITY|||||||0.2492||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.2492
91556750|NCT00145470|183002212|SUPERIORITY|||||||0.4683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4683
91556751|NCT00145470|183002213|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.5683
91768454|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-36.4|21.4||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||21.4|-36.4|1.000
91556752|NCT00145470|183002214|SUPERIORITY|||||||0.9693||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9693
91556753|NCT00145470|183002215|SUPERIORITY|||||||0.6136||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.6136
91556754|NCT00145470|183002216|SUPERIORITY|||||||0.1586||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.1586
91556755|NCT00145470|183002217|SUPERIORITY|||||||0.055||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 21||||0.0550
91556756|NCT00145470|183002217|SUPERIORITY|||||||0.7469||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 21||||0.7469
91768455|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-22.5|32.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||32.5|-22.5|1.000
91768456|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|-20.0||||0.272|TWO_SIDED|95.0|-37.5|-2.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||-2.5|-37.5|0.272
91556757|NCT00145470|183002217|SUPERIORITY|||||||0.3253||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 21||||0.3253
91556758|NCT00145470|183002217|SUPERIORITY|||||||0.3885||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 21||||0.3885
91556759|NCT00145470|183002217|SUPERIORITY|||||||0.5975||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 21||||0.5975
91556760|NCT00145470|183002217|SUPERIORITY|||||||0.069||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 21||||0.0690
91556761|NCT00145470|183002217|SUPERIORITY|||||||0.797||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 21||||0.7970
91556762|NCT00145470|183002217|SUPERIORITY|||||||0.8339||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 21||||0.8339
91556763|NCT00145470|183002217|SUPERIORITY|||||||0.2101||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 21||||0.2101
91768457|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-2.7|8.6||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||8.6|-2.7|1.000
91556764|NCT00145470|183002218|SUPERIORITY|||||||0.6914||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 84||||0.6914
91556765|NCT00145470|183002218|SUPERIORITY|||||||0.8805||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 84||||0.8805
91556766|NCT00145470|183002218|SUPERIORITY|||||||0.4878||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 84||||0.4878
91556767|NCT00145470|183002218|SUPERIORITY|||||||0.8051||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 84||||0.8051
91556768|NCT00145470|183002218|SUPERIORITY|||||||0.1925||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 84||||0.1925
91556769|NCT00145470|183002218|SUPERIORITY|||||||0.0514||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 84||||0.0514
91768458|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|13.0||||0.068|TWO_SIDED|95.0|-0.7|26.8||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||26.8|-0.7|0.068
91768459|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|-5.4||||1|TWO_SIDED|95.0|-23.1|12.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||12.3|-23.1|1.0000
91768460|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-15.7|18.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||18.3|-15.7|1.000
91556770|NCT00145470|183002218|SUPERIORITY|||||||0.9898||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 84||||0.9898
91556771|NCT00145470|183002218|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 84||||0.5683
91556772|NCT00145470|183002218|SUPERIORITY|||||||0.8907||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 84||||0.8907
91556773|NCT00145470|183002219|SUPERIORITY|||||||0.0613|||||||Log Rank|||||||0.0613
91556774|NCT00145470|183002220|SUPERIORITY|||||||0.7493||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.7493
91556775|NCT00145470|183002221|SUPERIORITY|||||||0.4884||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4884
91556776|NCT00145470|183002222|SUPERIORITY|||||||0.128||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 21||||0.1280
91556777|NCT00145470|183002222|SUPERIORITY|||||||0.0215||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 21||||0.0215
91556778|NCT00145470|183002223|SUPERIORITY|||||||0.1331||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 84||||0.1331
91556779|NCT00145470|183002223|SUPERIORITY|||||||0.2024||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 84||||0.2024
91556780|NCT02063659|183002251|SUPERIORITY||Hodges-Lehman estimator of difference|-53.955|||<|0.001|TWO_SIDED|95.0|-84.955|-25.119|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-25.119|-84.955|< 0.001
91556781|NCT02063659|183002251|SUPERIORITY||Hodges-Lehman estimator of difference|-89.662|||<|0.001|TWO_SIDED|95.0|-113.104|-63.863|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-63.863|-113.104|< 0.001
91556782|NCT00989196|183002259|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the comparison of the PK profile of Human-cl rhFVIII with Kogenate, the 90% confidence intervals for the ratio or log-ratio of Human-cl rhFVIII over Kogenate for selected, dose independent or dose adjusted, PK parameters will be presented. In addition a formal statistical procedure will test whether the ratio of mean AUCs is within a 80 to 125% range to show bioequivalence.|Ratio|0.98|||||TWO_SIDED|90.0|0.874|1.107||||||||1.107|0.874|
91556783|NCT04762277|183002269|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-31.7|23.4|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||23.4|-31.7|
91556784|NCT04762277|183002270|OTHER||Mean Difference (Net)|-96.6|||||TWO_SIDED|95.0|-154.5|-38.8|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-38.8|-154.5|
91556785|NCT04762277|183002271|OTHER||Risk Difference (RD)|0.138|||||TWO_SIDED|95.0|-0.129|0.339|||||Risk difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.339|-0.129|
91556786|NCT04762277|183002272|OTHER||Mean Difference (Net)|-13.9|||||TWO_SIDED|95.0|-25.6|-2.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.3|-25.6|
91556787|NCT04762277|183002273|OTHER||Mean Difference (Net)|-19.8|||||TWO_SIDED|95.0|-36.9|-2.7|||||Difference of Least Squares Means was calculated as : Spesolimab- Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.7|-36.9|
91556788|NCT04762277|183002274|OTHER||Risk Difference (RD)|0.057|||||TWO_SIDED|95.0|-0.132|0.186|||||Risk difference was calculated as: Spesolimab-Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.186|-0.132|
91556789|NCT04762277|183002275|OTHER||Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.067|0.338|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.338|-0.067|
91768461|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-16.7|23.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||23.3|-16.7|1.000
91768462|NCT02365649|183425710|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders||13.9|-4.3|1.000
91768463|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-35.5|35.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||35.5|-35.5|1.000
91556790|NCT04762277|183002276|OTHER||Risk Difference (RD)|0.183|||||TWO_SIDED|95.0|-0.079|0.375|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.375|-0.079|
91556791|NCT04762277|183002277|OTHER||Risk Difference (RD)|-0.091|||||TWO_SIDED|95.0|-0.331|0.089|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.089|-0.331|
91556792|NCT04762277|183002278|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-4.4|4.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||4.3|-4.4|
91556793|NCT04762277|183002279|OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-9.5|6.9|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||6.9|-9.5|
91556794|NCT00768716|183002307|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
91556795|NCT00768716|183002308|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
91556796|NCT00768716|183002309|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91556797|NCT00768716|183002311|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91556798|NCT00768716|183002312|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
91556799|NCT00768716|183002313|OTHER|||||||0.003|||||||ANOVA|||||||0.003
91556800|NCT05643885|183002316|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||||||<0.0001
91556801|NCT05643885|183002317|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||||||<0.0001
91556802|NCT05643885|183002318|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||||||<0.0001
91556803|NCT05643885|183002319|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||||||<0.0001
91556804|NCT05643885|183002320|SUPERIORITY||||||=|0.2303|||||||Weighted t-test|||||||=0.2303
91556805|NCT05643885|183002321|SUPERIORITY||||||=|0.7403|||||||Weighted t-test|||||||=0.7403
91556806|NCT05643885|183002322|SUPERIORITY||||||=|0.2414|||||||Weighted t-test|||||||=0.2414
91556807|NCT05643885|183002323|SUPERIORITY||||||=|0.2592|||||||Weighted t-test|||||||=0.2592
91556808|NCT05643885|183002324|SUPERIORITY||||||=|0.4837|||||||Weighted t-test|||||||=0.4837
91556809|NCT05643885|183002325|SUPERIORITY||||||=|0.1355|||||||Weighted t-test|||||||=0.1355
91556810|NCT05643885|183002326|SUPERIORITY||||||=|0.6066|||||||Weighted t-test|||||||=0.6066
91556811|NCT05643885|183002327|SUPERIORITY||||||=|0.3795|||||||Weighted t-test|||||||=0.3795
91556812|NCT05643885|183002328|SUPERIORITY||||||=|0.6618|||||||Weighted t-test|||||||=0.6618
91556813|NCT05643885|183002329|SUPERIORITY||||||=|0.2337|||||||Weighted t-test|||||||=0.2337
91556814|NCT05643885|183002330|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||Physician office visits||||<0.0001
91556815|NCT05643885|183002330|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||ER only visits||||<0.0001
91556816|NCT05643885|183002330|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||laboratory or pathology visits||||<0.0001
91556817|NCT05643885|183002330|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||Radiology||||<0.0001
91556818|NCT05643885|183002330|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||Surgical services||||<0.0001
91556819|NCT05643885|183002330|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||Ancillary/other services||||<0.0001
91556820|NCT05643885|183002331|SUPERIORITY||||||<|0.0001|||||||Weighted t-test|||||||<0.0001
91556821|NCT05643885|183002332|SUPERIORITY||||||=|0.729|||||||Weighted t-test|||||||=0.7290
91556822|NCT05643885|183002333|SUPERIORITY||||||=|0.3686|||||||Weighted t-test|||Physician office visits||||=0.3686
91556823|NCT05643885|183002333|SUPERIORITY||||||=|0.2747|||||||Weighted t-test|||ER only visits||||=0.2747
91556824|NCT05643885|183002333|SUPERIORITY||||||=|0.1049|||||||Weighted t-test|||Laboratory or pathology visits||||=0.1049
91556825|NCT05643885|183002333|SUPERIORITY||||||=|0.8425|||||||Weighted t-test|||Radiology||||=0.8425
91556826|NCT05643885|183002333|SUPERIORITY||||||=|0.9755|||||||Weighted t-test|||Surgical services||||=0.9755
91556827|NCT05643885|183002333|SUPERIORITY||||||=|0.0582|||||||Weighted t-test|||Ancillary or other services||||=0.0582
91556828|NCT05643885|183002334|SUPERIORITY||||||=|0.9796|||||||Weighted t-test|||||||=0.9796
91556829|NCT05643885|183002335|SUPERIORITY||||||=|0.0379|||||||Weighted t-test|||Physician office visits||||=0.0379
91556830|NCT05643885|183002335|SUPERIORITY||||||=|0.9034|||||||Weighted t-test|||ER only visits||||=0.9034
91556831|NCT05643885|183002335|SUPERIORITY||||||=|0.5452|||||||Weighted t-test|||Laboratory or pathology visits||||=0.5452
91556832|NCT05643885|183002335|SUPERIORITY||||||=|0.1644|||||||Weighted t-test|||Radiology||||=0.1644
91556833|NCT05643885|183002335|SUPERIORITY||||||=|0.065|||||||Weighted t-test|||Surgical services||||=0.0650
91556834|NCT05643885|183002335|SUPERIORITY||||||=|0.3866|||||||Weighted t-test|||Ancillary or other services||||=0.3866
91556835|NCT05643885|183002336|SUPERIORITY||||||=|0.566|||||||Weighted t-test|||||||=0.5660
91556836|NCT05643885|183002337|SUPERIORITY||||||=|0.0425|||||||Weighted t-test|||Physician office visits||||=0.0425
91556837|NCT05643885|183002337|SUPERIORITY||||||=|0.8634|||||||Weighted t-test|||ER only visits||||=0.8634
91556838|NCT05643885|183002337|SUPERIORITY||||||=|0.0399|||||||Weighted t-test|||Laboratory or pathology visits||||=0.0399
91556839|NCT05643885|183002337|SUPERIORITY||||||=|0.0996|||||||Weighted t-test|||Radiology||||=0.0996
91556840|NCT05643885|183002337|SUPERIORITY||||||=|0.7655|||||||Weighted t-test|||Surgical services||||=0.7655
91556841|NCT05643885|183002337|SUPERIORITY||||||=|0.1499|||||||Weighted t-test|||Ancillary or other services||||=0.1499
91556842|NCT05349721|183002349|OTHER||Treatment Difference|6.86||||0.516|TWO_SIDED|95.0|-13.86|27.59|||ANCOVA|Estimates were derived from the ANCOVA model (following multiple imputation), where participant ranks served as the response variable.||||27.59|-13.86|0.516
91556843|NCT00799409|183002367|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-35.0|-22.3||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.3|-35.0|<0.0001
91556844|NCT00799409|183002368|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-22.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.2|-34.4|<0.0001
91556845|NCT00799409|183002369|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|||<|0.0001|TWO_SIDED|95.0|4.3|7.4||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||7.4|4.3|<0.0001
91556846|NCT00799409|183002370|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|3.8|6.5||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||6.5|3.8|<0.0001
91556847|NCT00799409|183002371|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|8.7|13.3||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||13.3|8.7|<0.0001
91556848|NCT00799409|183002372|SUPERIORITY_OR_OTHER||LS Means Difference|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.59||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.59|-3.72|<0.0001
91556849|NCT00799409|183002373|SUPERIORITY_OR_OTHER||LS Means Difference|-16.03|||<|0.0001|TWO_SIDED|95.0|-19.99|-12.06||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-12.06|-19.99|<0.0001
91556850|NCT00799409|183002374|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.45|||<|0.0001|TWO_SIDED|95.0|-27.43|-17.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-17.47|-27.43|<0.0001
91556851|NCT00799409|183002375|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.93||||0.18|TWO_SIDED|95.0|-1.69|-0.16||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.16|-1.69|0.1800
91556852|NCT00799409|183002376|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32||||0.0057|TWO_SIDED|95.0|-2.25|-0.4||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.40|-2.25|0.0057
91556853|NCT00799409|183002377|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.1091|TWO_SIDED|95.0|-14.05|1.44||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||1.44|-14.05|0.1091
91556854|NCT00799409|183002378|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.2653|TWO_SIDED|95.0|-0.7|0.2||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.20|-0.70|0.2653
91556855|NCT00799409|183002379|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.49||||0.0038|TWO_SIDED|95.0|-10.81|-2.17||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.17|-10.81|0.0038
91556856|NCT00799409|183002380|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.75||||0.0001|TWO_SIDED|95.0|-6.96|-2.53||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.53|-6.96|0.0001
91556857|NCT00799409|183002381|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76||||0.0092|TWO_SIDED|95.0|-10.04|-1.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-1.47|-10.04|0.0092
91556858|NCT00799409|183002382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9195|TWO_SIDED|95.0|-0.37|0.33||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.33|-0.37|0.9195
91556859|NCT00799409|183002383|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.55||||0.0002|TWO_SIDED|95.0|-59.7|-19.39||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-19.39|-59.70|0.0002
91556860|NCT00799409|183002384|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.0002|TWO_SIDED|95.0|-0.13|-0.04||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.04|-0.13|0.0002
91556861|NCT00799409|183002385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.4625|TWO_SIDED|95.0|-0.07|0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.03|-0.07|0.4625
91556862|NCT00799409|183002386|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.6262|TWO_SIDED|95.0|-0.09|0.05||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.05|-0.09|0.6262
91556863|NCT00799409|183002387|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.998|TWO_SIDED|95.0|-0.08|0.08||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.08|-0.08|0.9980
91556864|NCT00799409|183002388|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.0151|TWO_SIDED|95.0|-0.19|-0.02||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.02|-0.19|0.0151
91556865|NCT00799409|183002389|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.0043|TWO_SIDED|95.0|-0.15|-0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.03|-0.15|0.0043
91556866|NCT00799409|183002390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.0371|TWO_SIDED|95.0|-0.08|0.0||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.00|-0.08|0.0371
91556867|NCT00799409|183002391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.0965|TWO_SIDED|95.0|-0.06|0.01||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.01|-0.06|0.0965
91556868|NCT04323800|183002392|SUPERIORITY||Risk Difference (RD)|0.01||||0.42|ONE_SIDED|95.0||||One-sided p-value|Restricted Mean Survival Test statistic|||||||0.42
91556869|NCT04323800|183002393|SUPERIORITY||Risk Difference (RD)|-5.0||||0.67|TWO_SIDED|95.0|-31.0|19.0|||Chi-squared|||||19|-31|0.67
91556870|NCT04323800|183002394|SUPERIORITY||Risk Difference (RD)|-47.0||||0.06|TWO_SIDED|95.0|-100.0|2.0|||Chi-squared|||||2|-100|0.06
91556871|NCT00731692|183002422|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.544|TWO_SIDED|95.0|0.8|1.12|||Regression, Cox|||||1.12|0.80|0.544
91556872|NCT02372799|183002437|SUPERIORITY||LSMD|-0.4||||0.7662|TWO_SIDED|95.0|-3.08|2.27|||MMRM|||||2.27|-3.08|0.7662
91556873|NCT02372799|183002437|SUPERIORITY||LSMD|-2.39||||0.1433|TWO_SIDED|95.0|-5.6|0.81|||MMRM|||||0.81|-5.60|0.1433
91556874|NCT02372799|183002438|SUPERIORITY||LSMD|-0.04||||0.7387|TWO_SIDED|95.0|-0.31|0.22|||MMRM|||||0.22|-0.31|0.7387
91556875|NCT02372799|183002438|SUPERIORITY||LSMD|-0.2||||0.2158|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||||0.12|-0.52|0.2158
91556876|NCT01767688|183002451|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.79|1.11|||Geometric least-squares mean ratio (GMR)|||||1.11|0.79|
91556877|NCT01767688|183002452|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.81|1.1|||Geometric least-squares mean ratio (GMR)|||||1.10|0.81|
91556878|NCT01767688|183002453|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.81|||||TWO_SIDED|95.0|0.51|1.28|||Geometric least-squares mean ratio (GMR)|||||1.28|0.51|
91556879|NCT01767688|183002454|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|1.03|||||TWO_SIDED|95.0|0.93|1.15|||Geometric least-squares mean ratio (GMR)|||||1.15|0.93|
91556880|NCT01583166|183002486|OTHER|||||||0.837|||||||Fisher Exact|||||||0.837
91556881|NCT03960645|183002514|OTHER||GLSM ratio (%)|41.24|||||TWO_SIDED|90.0|36.71|46.32||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio (%).||46.32|36.71|
91556882|NCT03960645|183002514|OTHER||GLSM ratio (%)|44.65|||||TWO_SIDED|90.0|40.04|49.79||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.79|40.04|
91556883|NCT03960645|183002514|OTHER||GLSM ratio (%)|40.57|||||TWO_SIDED|90.0|36.77|44.76||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||44.76|36.77|
91556884|NCT03960645|183002514|OTHER||GLSM ratio (%)|44.4|||||TWO_SIDED|90.0|39.95|49.34||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.34|39.95|
91556885|NCT03960645|183002515|OTHER||GLSM ratio (%)|67.38|||||TWO_SIDED|90.0|63.45|71.56||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||71.56|63.45|
91556886|NCT03960645|183002515|OTHER||GLSM ratio (%)|64.26|||||TWO_SIDED|90.0|60.95|67.75||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||67.75|60.95|
91556887|NCT03960645|183002515|OTHER||GLSM ratio (%)|69.19|||||TWO_SIDED|90.0|65.88|72.66||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||72.66|65.88|
91556888|NCT03960645|183002515|OTHER||GLSM ratio (%)|65.09|||||TWO_SIDED|90.0|61.79|68.57||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.57|61.79|
91556889|NCT03960645|183002515|OTHER||GLSM ratio (%)|77.62|||||TWO_SIDED|90.0|65.4|92.14||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||92.14|65.40|
91556890|NCT03960645|183002515|OTHER||GLSM ratio (%)|62.5|||||TWO_SIDED|90.0|50.76|76.96||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||76.96|50.76|
91556891|NCT03960645|183002515|OTHER||GLSM ratio (%)|69.67|||||TWO_SIDED|90.0|58.57|82.88||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.88|58.57|
91556892|NCT03960645|183002515|OTHER||GLSM ratio (%)|56.52|||||TWO_SIDED|90.0|46.32|68.96||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.96|46.32|
91556893|NCT03960645|183002517|OTHER||GLSM ratio (%)|51.91|||||TWO_SIDED|90.0|46.48|57.97||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||57.97|46.48|
91556894|NCT03960645|183002517|OTHER||GLSM ratio (%)|57.67|||||TWO_SIDED|90.0|52.48|63.36||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||63.36|52.48|
91556895|NCT03960645|183002517|OTHER||GLSM ratio (%)|48.18|||||TWO_SIDED|90.0|43.03|53.94||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||53.94|43.03|
91556896|NCT03960645|183002517|OTHER||GLSM ratio (%)|54.42|||||TWO_SIDED|90.0|48.39|61.21||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||61.21|48.39|
91556897|NCT03960645|183002517|OTHER||GLSM ratio (%)|75.61|||||TWO_SIDED|90.0|66.7|85.7||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.70|66.70|
91556898|NCT03960645|183002517|OTHER||GLSM ratio (%)|77.81|||||TWO_SIDED|90.0|68.76|88.05||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||88.05|68.76|
91556899|NCT03960645|183002517|OTHER||GLSM ratio (%)|77.45|||||TWO_SIDED|90.0|70.33|85.29||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.29|70.33|
91556900|NCT03960645|183002517|OTHER||GLSM ratio (%)|77.08|||||TWO_SIDED|90.0|69.78|85.15||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.15|69.78|
91556901|NCT03960645|183002517|OTHER||GLSM ratio (%)|69.9|||||TWO_SIDED|90.0|56.16|87.0||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||87.00|56.16|
91768464|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|12.5||||0.483|TWO_SIDED|95.0|-17.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||42.9|-17.9|0.483
91556902|NCT03960645|183002517|OTHER||GLSM ratio (%)|66.55|||||TWO_SIDED|90.0|53.79|82.34||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.34|53.79|
91768465|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|-15.0||||0.633|TWO_SIDED|95.0|-41.6|11.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||11.6|-41.6|0.633
91768466|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|6.9||||0.424|TWO_SIDED|95.0|-12.7|26.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||26.4|-12.7|0.424
91768467|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
91556903|NCT03960645|183002517|OTHER||GLSM ratio (%)|57.14|||||TWO_SIDED|90.0|46.04|70.91||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.91|46.04|
91556904|NCT03960645|183002517|OTHER||GLSM ratio (%)|55.27|||||TWO_SIDED|90.0|44.65|68.42||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.42|44.65|
91556905|NCT03960645|183002518|OTHER||GLSM ratio (%)|26.17|||||TWO_SIDED|90.0|21.45|31.93||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||31.93|21.45|
91556906|NCT03960645|183002518|OTHER||GLSM ratio (%)|26.99|||||TWO_SIDED|90.0|22.23|32.78||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.78|22.23|
91556907|NCT03960645|183002518|OTHER||GLSM ratio (%)|29.03|||||TWO_SIDED|90.0|25.74|32.74||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.74|25.74|
91556908|NCT03960645|183002518|OTHER||GLSM ratio (%)|29.97|||||TWO_SIDED|90.0|26.47|33.93||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||33.93|26.47|
91556909|NCT03960645|183002518|OTHER||GLSM ratio (%)|64.22|||||TWO_SIDED|90.0|54.63|75.49||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||75.49|54.63|
91768468|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|14.3||||0.149|TWO_SIDED|95.0|-2.4|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.9|-2.4|0.149
91556910|NCT03960645|183002518|OTHER||GLSM ratio (%)|42.89|||||TWO_SIDED|90.0|36.55|50.34||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||50.34|36.55|
91556911|NCT03960645|183002518|OTHER||GLSM ratio (%)|64.71|||||TWO_SIDED|90.0|59.3|70.61||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.61|59.30|
91556912|NCT03960645|183002518|OTHER||GLSM ratio (%)|46.92|||||TWO_SIDED|90.0|39.57|55.64||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||55.64|39.57|
91556913|NCT00790699|183002532|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||RM-ANOVA|||The results were evaluated to determine if any statistically significant changes in any of these measures between the first and final visit occurred and if these changes were associated with membership in the treatment or control group.||||>.05
91556914|NCT03732807|183002533|SUPERIORITY||Estimate of difference|29.11|||<|1e-06|TWO_SIDED|95.0|21.17|37.91|||Miettinen and Nurminen method|||||37.91|21.17|<0.000001
91556915|NCT03732807|183002533|SUPERIORITY||Estimate of difference|20.78|||<|1e-06|TWO_SIDED|95.0|13.65|29.18|||Miettinen and Nurminen method|||||29.18|13.65|<0.000001
91556916|NCT03732807|183002533|SUPERIORITY||Estimate of difference|21.85|||<|1e-06|TWO_SIDED|95.0|14.65|30.23|||Miettinen and Nurminen method|||||30.23|14.65|<0.000001
91556917|NCT03732807|183002533|SUPERIORITY||Estimate of difference|12.75||||0.000154|TWO_SIDED|95.0|6.69|20.36|||Miettinen and Nurminen method|||||20.36|6.69|0.000154
91556918|NCT03732807|183002534|SUPERIORITY||Estimate of difference|19.75|||<|1e-06|TWO_SIDED|95.0|11.91|27.59|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||27.59|11.91|<0.000001
91556919|NCT03732807|183002534|SUPERIORITY||Estimate of difference|11.33||||0.000526||95.0|4.93|17.74|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||17.74|4.93|0.000526
91556920|NCT03732807|183002534|SUPERIORITY||Estimate of difference|11.88||||0.000311||95.0|5.42|18.33|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||18.33|5.42|0.000311
91556921|NCT03732807|183002534|SUPERIORITY||Estimate of difference|9.09||||0.002922||95.0|3.1|15.07|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||15.07|3.10|0.002922
91556922|NCT03732807|183002535|SUPERIORITY||Estimate of difference|20.24|||<|1e-06||95.0|13.23|28.49|||Miettinen and Nurminen method|||||28.49|13.23|<0.000001
91556923|NCT03732807|183002535|SUPERIORITY||Estimate of difference|11.68||||0.000337||95.0|5.82|19.07|||Miettinen and Nurminen method|||||19.07|5.82|0.000337
91556924|NCT03732807|183002535|SUPERIORITY||Estimate of difference|12.17||||0.000228||95.0|6.27|19.53|||Miettinen and Nurminen method|||||19.53|6.27|0.000228
91556925|NCT03732807|183002535|SUPERIORITY||Estimate of difference|9.39||||0.001875|TWO_SIDED|95.0|3.86|16.46|||Miettinen and Nurminen method|||||16.46|3.86|0.001875
91556926|NCT03732807|183002536|SUPERIORITY||Estimate of difference|42.96|||<|1e-06|TWO_SIDED|95.0|31.68|54.25|||Miettinen and Nurminen method|||||54.25|31.68|<0.000001
91768469|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|5.8||||0.684|TWO_SIDED|95.0|-19.1|30.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||30.7|-19.1|0.684
91556927|NCT03732807|183002536|SUPERIORITY||Estimate of difference|36.18|||<|1e-06|TWO_SIDED|95.0|25.22|47.14|||Miettinen and Nurminen method|||||47.14|25.22|<0.000001
91556928|NCT03732807|183002536|SUPERIORITY||Estimate of difference|39.96|||<|1e-06|TWO_SIDED|95.0|28.85|51.06|||Miettinen and Nurminen method|||||51.06|28.85|<0.000001
91556929|NCT03732807|183002536|SUPERIORITY||Estimate of difference|32.72|||<|1e-06|TWO_SIDED|95.0|21.95|43.5|||Miettinen and Nurminen method|||||43.50|21.95|<0.000001
91556930|NCT03345979|183002556|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91556931|NCT03345979|183002556|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91556932|NCT00734578|183002567|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.5||||0.002||95.0|-7.5|-1.4||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-1.4|-7.5|0.002
91556933|NCT00734578|183002567|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.3|||<|0.001||95.0|-8.3|-2.3||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-2.3|-8.3|<0.001
91556934|NCT00734578|183002568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.024
91556935|NCT00734578|183002568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.003
91556936|NCT00734578|183002569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.013
91556937|NCT00734578|183002569|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
91556938|NCT00734578|183002570|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-1.7||||0.019||95.0|-3.2|-0.3||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.3|-3.2|0.019
91556939|NCT00734578|183002570|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.6|||<|0.001||95.0|-4.0|-1.1||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.1|-4.0|<0.001
91556940|NCT00734578|183002571|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.002||95.0|-4.0|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-4.0|0.002
91556941|NCT00734578|183002571|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-3.0|||<|0.001||95.0|-4.5|-1.5||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.5|-4.5|<0.001
91556942|NCT00734578|183002572|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
91556943|NCT00734578|183002572|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
91556944|NCT00734578|183002573|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.001||95.0|-3.9|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-3.9|0.001
91556945|NCT00734578|183002573|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.2||||0.003||95.0|-3.6|-0.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.7|-3.6|0.003
91556946|NCT00734578|183002574|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.1|||<|0.001||95.0|-8.0|-2.2||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-2.2|-8.0|<0.001
91556947|NCT00734578|183002574|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.7||||0.002||95.0|-7.6|-1.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.7|-7.6|0.002
91556948|NCT00734578|183002575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.971||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.971
91556949|NCT00734578|183002575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.502||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.502
91556950|NCT01953692|183002581|SUPERIORITY||||||>|0.9999||||||one-sided p value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||>0.9999
91556951|NCT01953692|183002582|SUPERIORITY||||||>|0.9999||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||>0.9999
91556952|NCT01953692|183002583|SUPERIORITY|||||||0.0306||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||0.0306
91556953|NCT01953692|183002584|SUPERIORITY|||||||0.7696||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||0.7696
91556954|NCT00731614|183002629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|||||||Repeated Measure ANOVA|||Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.||||.322
91556955|NCT02157948|183002638|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 - denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||One-sided p-value based on the prespecified non-inferiority margin of -1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
91556956|NCT02157948|183002638|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
91556957|NCT01701401|183002659|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91556958|NCT01701401|183002659|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91556959|NCT01701401|183002659|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91556960|NCT01701401|183002659|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
91556961|NCT05785832|183002684|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-0.8|<0.001
91556962|NCT05785832|183002685|SUPERIORITY||Mean Difference (Net)|14.0|||<|0.001|TWO_SIDED|95.0|11.0|17.0|||Regression, Linear|||Adjusted Difference Between Groups||17|11|<0.001
91768470|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|8.5||||0.404|TWO_SIDED|95.0|-11.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.5|-11.5|0.404
91768471|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|10.7||||0.47|TWO_SIDED|95.0|-12.8|34.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.1|-12.8|0.470
91556963|NCT05785832|183002686|SUPERIORITY||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.0|-15.0|||Regression, Linear|||Adjusted Difference Between Groups||-15|-26|<0.001
91556964|NCT05785832|183002687|SUPERIORITY||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.0|-11.0|||Regression, Linear|||Adjusted Difference Between Groups||-11|-17|<0.001
91556965|NCT05785832|183002688|SUPERIORITY||Mean Difference (Net)|-9.1|||<|0.001|TWO_SIDED|95.0|-11.7|-6.6|||Regression, Linear|||Adjusted Difference Between Groups||-6.6|-11.7|<0.001
91556966|NCT05785832|183002689|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-1.0|<0.001
91556967|NCT05785832|183002690|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||A hierarchical procedure was used to control for the overall type I error. Since the P value for this outcome was more than 0.05, no additional P values are provided for subsequent secondary outcomes.|Regression, Linear|||Adjusted Difference Between Groups||0.1|-0.4|
91556968|NCT05785832|183002691|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04|||Regression, Linear|||Adjusted Difference Between Groups||0.04|-0.09|
91768472|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
91768473|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
91768474|NCT02365649|183425711|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
91768475|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|-16.9||||0.624|TWO_SIDED|95.0|-48.4|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||14.6|-48.4|0.624
91556969|NCT05785832|183002692|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.0|||Regression, Linear|||Adjusted Difference Between Groups||0.0|-0.1|
91556970|NCT05785832|183002693|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||Regression, Linear|||Adjusted Difference Between Groups||1.2|-0.5|
91556971|NCT05785832|183002694|SUPERIORITY||Difference in percent of participants.|12.0|||||TWO_SIDED|95.0|1.0|21.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||21|1|
91556972|NCT05785832|183002695|SUPERIORITY||Difference in percent of participants.|18.0|||||TWO_SIDED|95.0|2.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|2|
91556973|NCT05785832|183002696|SUPERIORITY||Difference in percent of participants.|23.0|||||TWO_SIDED|95.0|12.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|12|
91556974|NCT05785832|183002697|SUPERIORITY||Difference in percent of participants.|25.0|||||TWO_SIDED|95.0|11.0|38.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||38|11|
91768476|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|3.9||||1|TWO_SIDED|95.0|-28.3|36.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||36.1|-28.3|1.000
91556975|NCT05785832|183002698|SUPERIORITY||Difference in percent of participants.|22.0|||||TWO_SIDED|95.0|11.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|11|
91556976|NCT05785832|183002699|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|10.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|10|
91556977|NCT05785832|183002700|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|9.0|31.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||31|9|
91556978|NCT05785832|183002701|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|7.0|12.0||||||Adjusted Difference Between Groups||12|7|
91556979|NCT05785832|183002702|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
91556980|NCT05785832|183002703|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.07|0.01||||||Adjusted Difference Between Groups||0.01|-0.07|
91556981|NCT05785832|183002704|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|95.0|-6.0|-2.7||||||Adjusted Difference Between Groups||-2.7|-6.0|
91556982|NCT05785832|183002705|SUPERIORITY||Mean Difference (Net)|-14.0|||||TWO_SIDED|95.0|-18.0|-10.0||||||Adjusted Difference Between Groups||-10|-18|
91556983|NCT05785832|183002706|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-5.2|-2.7||||||Adjusted Difference Between Groups||-2.7|-5.2|
91556984|NCT05785832|183002707|SUPERIORITY||Difference in percent of participants.|16.0|||||TWO_SIDED|95.0|8.0|24.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||24|8|
91556985|NCT05785832|183002708|SUPERIORITY||Difference in percent of participants.|26.0|||||TWO_SIDED|95.0|12.0|41.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||41|12|
91556986|NCT05785832|183002709|SUPERIORITY||Difference in percent of participants.|34.0|||||TWO_SIDED|95.0|21.0|45.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||45|21|
91556987|NCT05785832|183002712|SUPERIORITY||Difference in percent of participants.|15.0|||||TWO_SIDED|95.0|8.0|22.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||22|8|
91556988|NCT05785832|183002713|SUPERIORITY||Mean Difference (Net)|-10.0|||||TWO_SIDED|95.0|-20.0|0.0||||||Adjusted Difference Between Groups.||0|-20|
91556989|NCT05785832|183002714|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||||||Adjusted Difference Between Groups.||3.4|-4.4|
91556990|NCT05785832|183002715|SUPERIORITY||Median Difference (Net)|1.5|||||TWO_SIDED|95.0|0.5|2.5||||||Adjusted Difference Between Groups.||2.5|0.5|
91556991|NCT05785832|183002716|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.5|4.7||||||Adjusted Difference Between Groups.||4.7|-2.5|
91556992|NCT05785832|183002717|SUPERIORITY||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.7||||||Adjusted Difference Between Groups.||0.7|-3.4|
91556993|NCT05785832|183002718|SUPERIORITY||Median Difference (Net)|2.1|||||TWO_SIDED|95.0|0.5|3.7||||||Adjusted Difference Between Groups.||3.7|0.5|
91556994|NCT05785832|183002719|SUPERIORITY||Mean Difference (Net)|4.9|||||TWO_SIDED|95.0|-1.4|11.1||||||Adjusted Difference Between Groups.||11.1|-1.4|
91556995|NCT05785832|183002720|SUPERIORITY||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-45.0|4.0||||||Adjusted Difference Between Groups.||4|-45|
91556996|NCT00108355|183002730|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Log Rank|||Initial estimation: median time to recurrence of ascites of 38 days in the study group and 20 days in the control group in a fixed duration of 6 months (5% type-I error (2 sided) and an 80% power). However, due to low accrual and based on randomized trials using vasoconstrictors in the prevention of PCD and a study that showed that midodrine leads to a significant improvement in effective arterial blood volume, each of which had sample sizes of 24-25 patients,we decided on a sample size of 30.||||<0.05
91556997|NCT03883724|183002732|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in NPi pre- vs post-intervention comparing between group analysis||||0.3
91556998|NCT03883724|183002733|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome|||||<|0.01||||||Change in nocturia frequency pre- vs post-intervention comparing between groups BBTI vs IC|ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in nocturia frequency pre- vs post-intervention comparing between group analysis||||<.01
91556999|NCT03883724|183002734|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||0.3
91557000|NCT03739866|183002742|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91557001|NCT03739866|183002742|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91557002|NCT03739866|183002742|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91557003|NCT03739866|183002742|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91557004|NCT03739866|183002742|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91768477|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|-19.4||||0.363|TWO_SIDED|95.0|-48.0|9.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||9.1|-48.0|0.363
91557005|NCT01034306|183002769|SUPERIORITY|||||||0.0352||||||normal approximation to the binomial test|t-test, 2 sided|||||||0.0352
91557006|NCT01034306|183002770|SUPERIORITY|||||||0.2472|||||||t-test, 2 sided|||||||.2472
91557007|NCT01034306|183002771|SUPERIORITY|||||||0.1972|||||||t-test, 2 sided|||||||0.1972
91557008|NCT03057600|183002772|SUPERIORITY|||||||0.2252|||||||exact one-sample binomial tests|||||||0.2252
91557009|NCT03057600|183002772|SUPERIORITY|||||||0.9437|||||||exact one-sample binomial tests|||||||0.9437
91557010|NCT03057600|183002772|SUPERIORITY|||||||0.5797|||||||exact one-sample binomial tests|||||||0.5797
91557011|NCT03057600|183002772|SUPERIORITY|||||||0.0243|||||||exact one-sample binomial tests|||||||0.0243
91557012|NCT01604824|183002778|SUPERIORITY||LS Mean Difference|-53.72|STANDARD_ERROR_OF_MEAN|11.486|=|0.0009|TWO_SIDED|95.0|-79.31|-28.12||Threshold for significance ≤ 0.05|ANCOVA|||||-28.12|-79.31|= 0.0009
91557013|NCT01604824|183002778|SUPERIORITY||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|10.965|=|0.0056|TWO_SIDED|95.0|-69.21|17.35||Threshold for significance ≤ 0.05|ANCOVA|||||17.35|-69.21|= 0.0056
91557014|NCT01604824|183002779|SUPERIORITY||LS Mean Difference|-49.55|STANDARD_ERROR_OF_MEAN|12.05|=|0.0021|TWO_SIDED|95.0|-76.39|-22.7||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||-22.7|-76.39|= 0.0021
91557015|NCT01604824|183002779|SUPERIORITY||LS Mean Difference|-44.64|STANDARD_ERROR_OF_MEAN|10.876|=|0.0045|TWO_SIDED|95.0|-70.36|18.92||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||18.92|-70.36|= 0.0045
91557016|NCT01604824|183002780|SUPERIORITY||LS Mean Difference|-49.37|STANDARD_ERROR_OF_MEAN|11.487|=|0.0016|TWO_SIDED|95.0|-74.96|-23.77||Threshold for significance ≤ 0.05|ANCOVA|||||-23.77|-74.96|= 0.0016
91557017|NCT01604824|183002780|SUPERIORITY||LS Mean Difference|-40.36|STANDARD_ERROR_OF_MEAN|10.471|=|0.0063|TWO_SIDED|95.0|-65.12|15.6||Threshold for significance ≤ 0.05|ANCOVA|||||15.60|-65.12|= 0.0063
91557018|NCT01604824|183002781|SUPERIORITY||LS Mean Difference|-30.75|STANDARD_ERROR_OF_MEAN|7.224|=|0.0017|TWO_SIDED|95.0|-46.85|-14.66||Threshold for significance ≤ 0.05|ANCOVA|||||-14.66|-46.85|= 0.0017
91557019|NCT01604824|183002781|SUPERIORITY||LS Mean Difference|-22.23|STANDARD_ERROR_OF_MEAN|6.294|=|0.0096|TWO_SIDED|95.0|-37.11|-7.34||Threshold for significance ≤ 0.05|ANCOVA|||||-7.34|-37.11|= 0.0096
91557020|NCT01604824|183002782|SUPERIORITY||LS Mean Difference|-49.72|STANDARD_ERROR_OF_MEAN|9.867|=|0.0005|TWO_SIDED|95.0|-71.71|-27.74||Threshold for significance ≤ 0.05|ANCOVA|||||-27.74|-71.71|= 0.0005
91557021|NCT01604824|183002782|SUPERIORITY||LS Mean Difference|-49.33|STANDARD_ERROR_OF_MEAN|11.545|=|0.0037|TWO_SIDED|95.0|-76.63|-22.03||Threshold for significance ≤ 0.05|ANCOVA|||||-22.03|-76.63|= 0.0037
91768478|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|6.1||||0.495|TWO_SIDED|95.0|-2.1|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.2|-2.1|0.495
91557022|NCT02502461|183002912|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.04|TWO_SIDED|95.0|0.1|1.7||Bonferroni correction|t-test, 2 sided|||||1.7|0.1|0.04
91557023|NCT02409680|183002929|SUPERIORITY||Risk Ratio (RR)|0.89||||0.012|TWO_SIDED|95.0|0.81|0.98||A-priori threshold for statistical significance at 0.05 was specified.|Cochran-Mantel-Haenszel|||The null hypothesis is there is no treatment effect on preterm delivery.||0.98|0.81|0.012
91557024|NCT02409680|183002930|SUPERIORITY||Risk Ratio (RR)|1.08||||0.299|TWO_SIDED|95.0|0.94|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.94|0.299
91557025|NCT02409680|183002931|SUPERIORITY||Risk Ratio (RR)|0.95||||0.171|TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|0.171
91557026|NCT02409680|183002932|SUPERIORITY||Risk Ratio (RR)|0.86||||0.048|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.048
91557027|NCT02409680|183002933|SUPERIORITY||Risk Ratio (RR)|0.87||||0.125|TWO_SIDED|95.0|0.73|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.73|0.125
91557028|NCT02409680|183002934|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.6|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.60|0.900
91557029|NCT02409680|183002935|SUPERIORITY||Risk Ratio (RR)|1.25||||0.274|TWO_SIDED|95.0|0.84|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.84|0.274
91557030|NCT02409680|183002936|SUPERIORITY||Risk Ratio (RR)|0.75||||0.512|TWO_SIDED|95.0|0.32|1.78|||Cochran-Mantel-Haenszel|||||1.78|0.32|0.512
91768479|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|15.0||||0.066|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.6|-0.6|0.066
91768480|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|-10.7||||0.645|TWO_SIDED|95.0|-30.3|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||8.9|-30.3|0.645
91768481|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|4.4||||0.686|TWO_SIDED|95.0|-16.8|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||25.5|-16.8|0.686
91557031|NCT02409680|183002937|SUPERIORITY||Risk Ratio (RR)|0.77||||0.331|TWO_SIDED|95.0|0.45|1.31|||Cochran-Mantel-Haenszel|||||1.31|0.45|0.331
91557032|NCT02409680|183002939|SUPERIORITY||Risk Ratio (RR)|0.38||||0.015|TWO_SIDED|95.0|0.17|0.85|||Cochran-Mantel-Haenszel|||||0.85|0.17|0.015
91557033|NCT02409680|183002940|SUPERIORITY||Risk Ratio (RR)|0.75||||0.039|TWO_SIDED|95.0|0.61|0.93|||Cochran-Mantel-Haenszel|||||0.93|0.61|0.039
91557034|NCT02409680|183002941|SUPERIORITY||Risk Ratio (RR)|0.93||||0.073|TWO_SIDED|95.0|0.87|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.87|0.073
91557035|NCT02409680|183002942|SUPERIORITY||Risk Ratio (RR)|0.87||||0.084|TWO_SIDED|95.0|0.57|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.57|0.084
91557036|NCT02409680|183002943|SUPERIORITY||Risk Ratio (RR)|0.86||||0.039|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.039
91557037|NCT02409680|183002944|SUPERIORITY||Risk Ratio (RR)|0.88||||0.261|TWO_SIDED|95.0|0.7|1.1|||Cochran-Mantel-Haenszel|||||1.10|0.70|0.261
91557038|NCT02409680|183002945|SUPERIORITY||Risk Ratio (RR)|0.85||||0.141|TWO_SIDED|95.0|0.68|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.68|0.141
91557039|NCT02409680|183002946|SUPERIORITY||Risk Ratio (RR)|1.4||||0.157|TWO_SIDED|95.0|0.88|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.88|0.157
91557040|NCT02921555|183002954|SUPERIORITY||Mean Difference (Final Values)|16.2||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
91557041|NCT02921555|183002954|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91557042|NCT05986617|183002994|SUPERIORITY|||||||0.06429||||||2-tail t-test with non-equivalent variances|t-test, 2 sided|||Power calculation: 2 factor (group, time) ANOVA design with a group\*time interaction term to estimate the proposed sample size. Using a Cohen's effect size estimate for 2 groups with 5 time-points, a sample size of 40 per group will provide \>90% to detect a moderate effect size (0.25) for group, for time and for the group\*time interaction.||||.06429
91557043|NCT04701203|183003003|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||For the primary efficacy endpoint, the Cochran-Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with \>25% (ie, \>7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.||||<0.0001
91557044|NCT04701203|183003004|SUPERIORITY||||||=|0.0038|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0038
91557045|NCT04701203|183003005|SUPERIORITY||||||=|0.0055|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0055
91557046|NCT04701203|183003006|SUPERIORITY||||||=|0.0046|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0046
91557047|NCT04701203|183003007|SUPERIORITY||||||=|0.0061|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0061
91557048|NCT04701203|183003008|SUPERIORITY||||||=|0.0347|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0347
91557049|NCT05293717|183003049|OTHER|This is an open-label study. No power calculation was performed.|||||<|0.001|||||||ANOVA|||||||<0.001
91557050|NCT03147287|183003050|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.62|TWO_SIDED|90.0|0.79|1.55||We reported two-sided p-values corresponding to two-sided α level of 0.10. The test statistic and p-value were taken from the Cox proportional hazards model score test.|Log Rank|The SAP intended stratified tests and models, however one stratum was only 9 patients making implementation of stratification questionable.|We checked the proportional hazards assumption by visually assessing the plot of log( log(survival)) vs log of survival times according to treatment assignment for parallelism. This was done overall and according to stratum.|The primary objective was investigated by comparing the PFS distributions between two treatment arms using a logrank test with one-sided α level of 0.05 (H0: PFS1≤PFS2; HA: PFS1\>PFS2). Hazard ratios were estimated from a Cox PH model (F+P / F, so that HR\<1 indicates reduced hazard of PFS event with F+P), with two sided 90% CIs (Wald) to align with the design and testing.||1.55|0.79|0.62
91768482|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|4.4||||0.721|TWO_SIDED|95.0|-19.5|28.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.2|-19.5|0.721
91768483|NCT02365649|183425712|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.9|-4.3|1.000
91768484|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.5|-47.5|1.000
91557051|NCT03147287|183003051|SUPERIORITY|||||||1||||||P-value is two sided, for hypothesis test with two-sided α=0.10|Fisher Exact|||The objective response was reported with two-sided 90% CI and compared between two treatment arms using a (unstratified) Fisher's exact test;||||1.000
91557052|NCT04921358|183003100|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% Tumor Cells (TC) vs \>=1% TC).|||1.39|0.75|
91557053|NCT04921358|183003101|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.62|1.07|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||1.07|0.62|
91557054|NCT04921358|183003102|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||0.83|0.50|
91768485|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|5.0||||0.765|TWO_SIDED|95.0|-27.8|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||37.8|-27.8|0.765
91768486|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.4|-42.4|1.000
91557055|NCT01256359|183003122|SUPERIORITY||Hazard Ratio (HR)|0.753||||0.13|TWO_SIDED|90.0|0.498|1.138||p value \< 0.1 one-sided considered to be significant.|Regression, Cox||HR is Adjusted for M status, performance status|||1.138|0.498|0.130
91557056|NCT01256359|183003122|SUPERIORITY||Hazard Ratio (HR)|0.723||||0.113|TWO_SIDED|90.0|0.465|1.123|||Regression, Cox||This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status|This is a sensitivity analysis of the primary outcome. This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status||1.123|0.465|0.113
91768487|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||32.5|-47.5|1.000
91768488|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|11.3||||0.502|TWO_SIDED|95.0|-21.4|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||43.9|-21.4|0.502
91768489|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-32.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||42.9|-32.9|1.000
91768490|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-42.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||37.3|-42.3|1.000
91557057|NCT01256359|183003122|SUPERIORITY|||||||0.3016||||||This analysis assesses if allowing for interval censoring is consistent with the primary outcome results.|Generalised log-rank|Generalised log-rank taking into account interval censoring, analysed using SAS package version 9.2. Method by Zhao and Sun, 2004||This is a sensitivity analysis, including all 83 randomised patients. Patients are assessed periodically for the response (progression), the time when the event occurred is not directly observed but is known to take place within some time interval. Progression is known only to have occurred at some time between visits, the exact time is not known. We carried out interval censored analysis to demonstrate if allowing for interval censoring gives a different interpretation of the primary outcome.||||0.3016
91768491|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|22.5||||0.18|TWO_SIDED|95.0|-9.5|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||54.5|-9.5|0.180
91768492|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||25.6|-45.6|0.702
91557058|NCT01256359|183003122|SUPERIORITY||Hazard Ratio (HR)|1.348||||0.305|TWO_SIDED|90.0|0.602|3.016|||Regression, Cox||Adjusted for centre|Sensitivity analysis adjusting for centre. All 83 randomised patients were included in analysis. Centres were the three biggest recruiters and all other 13 centres are combined.||3.016|0.602|0.305
91557059|NCT01256359|183003123|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.187|TWO_SIDED|90.0|-3.4|31.4|||Log Rank||This is the estimated difference in PFS rate i.e. % difference between arms|||31.4|-3.4|0.187
91557060|NCT01256359|183003124|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.169|TWO_SIDED|90.0|0.797|2.369|||Regression, Cox|p value \< 0.1 one-sided considered to be significant.||||2.369|0.797|0.169
91557061|NCT01256359|183003125|SUPERIORITY|||||||0.059|||||||Chi-squared|||Objective response rate calculated as number of patients with CR or PR over all patients randomised.||||0.059
91557062|NCT01256359|183003126|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.318|TWO_SIDED|90.0|0.71|1.84|||Regression, Cox|||Analysis adjusted for with Mstatus and Performance Score||1.84|0.71|0.318
91557063|NCT01256359|183003164|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.468|TWO_SIDED|90.0|0.649|1.612|||Regression, Cox||Analysis Adjusted for M status, performance status|This is a sensitivity analysis of the primary outcome.||1.612|0.649|0.468
91557064|NCT01256359|183003165|SUPERIORITY||Hazard Ratio (HR)|0.721||||0.106|TWO_SIDED|90.0|0.468|1.109|||Regression, Cox||Analysis was adjusted for mstatus, performance status|This is the per-protocol analysis of the primary outcome.||1.109|0.468|0.106
91557065|NCT01256359|183003166|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.824|TWO_SIDED|95.0|0.25|1.53||p-value is for the interaction term|Regression, Cox||HRs (95% CI) between treatment groups are given for Wild type and NRAS mutated separately. The above HR is for WT.|Model with interaction term between NRAS status and treatment group and stratification variables||1.53|0.25|0.824
91557066|NCT01256359|183003167|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.072|TWO_SIDED|95.0|0.16|1.6||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.60|0.16|0.072
91557067|NCT01256359|183003167|SUPERIORITY||Hazard Ratio (HR)|1.97|||||TWO_SIDED|95.0|0.73|5.33|||||HR for NRAS mutated patients|||5.33|0.73|
91557068|NCT01256359|183003169|SUPERIORITY|Adjusted for with Mstatus and Performance Score|Hazard Ratio (HR)|1.12||||0.348|TWO_SIDED|90.0|0.68|1.87|||Regression, Cox|||||1.87|0.68|0.348
91557069|NCT01256359|183003170|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.797|TWO_SIDED|90.0|0.24|1.58||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.58|0.24|0.797
91557070|NCT01256359|183003170|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.35|1.45|||||HR for NRAS mutated patients|||1.45|0.350|
91557071|NCT01256359|183003171|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.12|TWO_SIDED|95.0|0.18|1.97||Model includes interaction term between NRAS status and treatment group and stratification variables. p-value is for interaction term.|Regression, Cox||"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.97|0.18|0.120
91557072|NCT01256359|183003171|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|0.73|5.38|||||HR for NRAS mutated patients|||5.38|0.73|
91557073|NCT03737110|183003184|SUPERIORITY||Hazard Ratio (HR)|0.04|||<|0.0001|TWO_SIDED|95.0|0.01|0.18||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at Run-In Baseline.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.18|0.01|<0.0001
91557074|NCT03737110|183003185|SUPERIORITY||Odds Ratio (OR)|12.727||||0.0002|TWO_SIDED|95.0|2.438|66.428||95% confidence interval (CI) and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||66.428|2.438|0.0002
91557075|NCT03737110|183003185|SUPERIORITY||Difference in percentages|61.0|||||TWO_SIDED|95.0|36.7|85.2|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||85.2|36.7|
91557076|NCT03737110|183003186|SUPERIORITY||Least squares (LS) mean difference|51.2|||<|0.0001|TWO_SIDED|95.0|34.5|68.0||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||68.0|34.5|< 0.0001
91557077|NCT03737110|183003187|SUPERIORITY||Odds Ratio (OR)|10.0||||0.0006|TWO_SIDED|95.0|2.136|46.826||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||46.826|2.136|0.0006
91557078|NCT03737110|183003187|SUPERIORITY||Difference in percentages|56.0|||||TWO_SIDED|95.0|30.6|81.3|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||81.3|30.6|
91557079|NCT03737110|183003188|SUPERIORITY||Odds Ratio (OR)|8.37||||0.0022|TWO_SIDED|95.0|1.317|53.188||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||53.188|1.317|0.0022
91557080|NCT03737110|183003189|SUPERIORITY||Odds Ratio (OR)|10.906|||<|0.0001|TWO_SIDED|95.0|3.051|38.981||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||38.981|3.051|< 0.0001
91557081|NCT03737110|183003190|SUPERIORITY||LS mean difference|51.9|||<|0.0001|TWO_SIDED|95.0|33.8|70.1||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||70.1|33.8|< 0.0001
91557082|NCT03737110|183003191|SUPERIORITY||LS mean difference|40.5|||<|0.0001|TWO_SIDED|95.0|25.3|55.8||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||55.8|25.3|< 0.0001
91557083|NCT03737110|183003192|SUPERIORITY||Odds Ratio (OR)|30.522||||0.0002|TWO_SIDED|95.0|4.262|218.552||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test adjusted by oral corticosteroid use at RI baseline.|Cochran-Mantel-Haenszel|||||218.552|4.262|0.0002
91557084|NCT03737110|183003193|SUPERIORITY||Odds Ratio (OR)|14.432|||<|0.0001|TWO_SIDED|95.0|3.439|60.574||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||60.574|3.439|< 0.0001
91557085|NCT03737110|183003194|SUPERIORITY||Difference|75.7|||<|0.0001|TWO_SIDED|95.0|56.8|94.6|||normal approximation|||||94.6|56.8|< 0.0001
91557086|NCT03737110|183003195|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.32||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.32|0.05|< 0.0001
91557087|NCT03737110|183003196|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.22|0.02|< 0.0001
91557088|NCT03737110|183003197|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.7447|TWO_SIDED|95.0|0.12|4.46||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||4.46|0.12|0.7447
91768493|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-27.5||||0.214|TWO_SIDED|95.0|-58.9|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||3.9|-58.9|0.214
91557089|NCT03737110|183003198|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.2066|TWO_SIDED|95.0|0.07|1.87||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||1.87|0.07|0.2066
91557090|NCT03737110|183003199|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0059|TWO_SIDED|95.0|0.0||Not estimable due to low number of participants with an event.|Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||||||0.00|0.0059
91557091|NCT03737110|183003211|SUPERIORITY||Odds Ratio (OR)|0.015|||<|0.0001|TWO_SIDED|95.0|0.002|0.108||Two-sided p value calculated using a Cochran-Mantel-Haenszel test adjudicated by randomization strata.|Cochran-Mantel-Haenszel|||Participants who used ORT, corticosteroids or bailout rilonacept during the RW Period||0.108|0.002|< 0.0001
91557092|NCT04237792|183003267|OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.29|||Cochran-Mantel-Haenszel|||||0.29|0.03|<0.001
91557093|NCT04237792|183003268|OTHER||Odds Ratio (OR)|0.18||||0.022|TWO_SIDED|95.0|0.04|0.82|||Mantel Haenszel|||||0.82|0.04|0.022
91557094|NCT04237792|183003268|OTHER||Odds Ratio (OR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.26|||Mantel Haenszel|||||0.26|0.01|<0.001
91557095|NCT04237792|183003269|OTHER||Odds Ratio (OR)|0.11||||0.006|TWO_SIDED|95.0|0.02|0.59|||Mantel Haenszel|||||0.59|0.02|0.006
91557096|NCT04237792|183003269|OTHER||Odds Ratio (OR)|1.68||||0.597|TWO_SIDED|95.0|0.25|11.27|||Mantel Haenszel|||||11.27|0.25|0.597
91557097|NCT04237792|183003269|OTHER||Odds Ratio (OR)|0.54||||0.374|TWO_SIDED|95.0|0.14|2.07|||Mantel Haenszel|||||2.07|0.14|0.374
91557098|NCT04237792|183003269|OTHER||Odds Ratio (OR)|0.1||||0.001|TWO_SIDED|95.0|0.02|0.44|||Mantel Haenszel|||||0.44|0.02|0.001
91557099|NCT04237792|183003269|OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.81|||Mantel Haenszel|||||0.81|0.13|0.015
91557100|NCT04237792|183003269|OTHER||Odds Ratio (OR)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.87|||Mantel Haenszel|||||0.87|0.10|0.024
91557101|NCT04237792|183003270|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
91557102|NCT04237792|183003270|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91557103|NCT04237792|183003270|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
91557104|NCT04237792|183003270|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
91557105|NCT04237792|183003270|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91557106|NCT04237792|183003270|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
91557107|NCT04237792|183003270|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91557108|NCT04237792|183003270|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91557109|NCT04237792|183003270|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91557110|NCT04237792|183003271|OTHER|||||||0.016|||||||Log Rank|||||||0.016
91557111|NCT04237792|183003271|OTHER|||||||0.005|||||||Log Rank|||||||0.005
91557112|NCT04237792|183003271|OTHER|||||||0.368|||||||Log Rank|||||||0.368
91557113|NCT04237792|183003271|OTHER|||||||0.358|||||||Log Rank|||||||0.358
91557114|NCT04237792|183003271|OTHER|||||||0|||||||Log Rank|||||||0.000
91557115|NCT04237792|183003271|OTHER|||||||0.001|||||||Log Rank|||||||0.001
91557116|NCT04237792|183003271|OTHER|||||||0.02|||||||Log Rank|||||||0.020
91557117|NCT04237792|183003271|OTHER|||||||0|||||||Log Rank|||||||0.000
91557118|NCT04237792|183003271|OTHER|||||||0.005|||||||Log Rank|||||||0.005
91557119|NCT04237792|183003272|OTHER|||||||0.884|||||||Log Rank|||||||0.884
91557120|NCT04237792|183003272|OTHER|||||||0.662|||||||Log Rank|||||||0.662
91557121|NCT04237792|183003272|OTHER|||||||0.236|||||||Log Rank|||||||0.236
91557122|NCT04237792|183003272|OTHER|||||||0.733|||||||Log Rank|||||||0.733
91557123|NCT04237792|183003272|OTHER|||||||0.128|||||||Log Rank|||||||0.128
91557124|NCT04237792|183003272|OTHER|||||||0.165|||||||Log Rank|||||||0.165
91557125|NCT04237792|183003272|OTHER|||||||0.752|||||||Log Rank|||||||0.752
91557126|NCT04237792|183003272|OTHER|||||||0.139|||||||Log Rank|||||||0.139
91557127|NCT04237792|183003272|OTHER|||||||0.051|||||||Log Rank|||||||0.051
91557128|NCT04237792|183003274|OTHER|||||||0.124|||||||ANOVA|||||||0.124
91557129|NCT04237792|183003274|OTHER|||||||0.186|||||||ANOVA|||||||0.186
91557130|NCT04237792|183003274|OTHER|||||||0.47|||||||ANOVA|||||||0.470
91557131|NCT04237792|183003274|OTHER|||||||0.845|||||||ANOVA|||||||0.845
91557132|NCT04237792|183003274|OTHER|||||||0.621|||||||ANOVA|||||||0.621
91557133|NCT04237792|183003274|OTHER|||||||0.747|||||||ANOVA|||||||0.747
91557134|NCT04237792|183003274|OTHER|||||||0.218|||||||ANOVA|||||||0.218
91557135|NCT04237792|183003274|OTHER|||||||0.181|||||||ANOVA|||||||0.181
91557136|NCT04237792|183003274|OTHER|||||||0.984|||||||ANOVA|||||||0.984
91557137|NCT04237792|183003275|OTHER|||||||0.048|||||||ANOVA|||||||0.048
91557138|NCT04237792|183003275|OTHER|||||||0.106|||||||ANOVA|||||||0.106
91557139|NCT04237792|183003275|OTHER|||||||0.196|||||||ANOVA|||||||0.196
91557140|NCT04237792|183003275|OTHER|||||||0.94|||||||ANOVA|||||||0.940
91557141|NCT04237792|183003275|OTHER|||||||0.824|||||||ANOVA|||||||0.824
91557142|NCT04237792|183003275|OTHER|||||||0.678|||||||ANOVA|||||||0.678
91557143|NCT04237792|183003275|OTHER|||||||0.129|||||||ANOVA|||||||0.129
91557144|NCT04237792|183003275|OTHER|||||||0.16|||||||ANOVA|||||||0.160
91557145|NCT04237792|183003275|OTHER|||||||0.872|||||||ANOVA|||||||0.872
91557146|NCT03052517|183003294|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|1.0|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.00|0.74|
91557147|NCT03052517|183003294|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.72|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.72|
91557148|NCT03052517|183003294|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.09|0.87|
91557149|NCT03052517|183003295|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.02|0.76|
91557150|NCT03052517|183003295|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.99|0.73|
91557151|NCT03052517|183003295|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.08|0.86|
91557152|NCT03052517|183003296|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.51|
91557153|NCT03052517|183003296|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.39|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.39|
91557154|NCT03052517|183003296|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.14|0.54|
91557155|NCT03052517|183003297|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.54|
91557156|NCT03052517|183003297|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.41|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.41|
91557157|NCT03052517|183003297|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.55|1.11|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.11|0.55|
91557158|NCT03052517|183003298|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.47|2.23|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.23|0.47|
91557159|NCT03052517|183003298|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.59|2.64|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.64|0.59|
91557160|NCT03052517|183003298|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||2.10|0.70|
91557161|NCT03052517|183003299|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.56|2.56|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.56|0.56|
91557162|NCT03052517|183003299|OTHER||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.67|2.95|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.95|0.67|
91557163|NCT03052517|183003299|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.7|1.96|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.96|0.70|
91557164|NCT03052517|183003300|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.626|1.047|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.047|0.626|
91557165|NCT03052517|183003300|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.622|1.038|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.038|0.622|
91557166|NCT03052517|183003300|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.821|1.2|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.200|0.821|
91557167|NCT03052517|183003301|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.667|1.125|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.125|0.667|
91557168|NCT03052517|183003301|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.643|1.082|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.082|0.643|
91768494|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.0|-2.5|0.086
91557169|NCT03052517|183003301|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.794|1.167|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.167|0.794|
91557170|NCT00910962|183003331|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.411|TWO_SIDED|95.0|0.46|1.38|||Cox' proportional hazards model|||||1.38|0.46|0.4110
91557171|NCT00910962|183003331|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9318|TWO_SIDED|95.0|0.6|1.74|||Cox' proportional hazards model|||||1.74|0.60|0.9318
91557172|NCT00910962|183003331|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6805|TWO_SIDED|95.0|0.56|1.46|||Cox' proportional hazards model|||||1.46|0.56|0.6805
91557173|NCT00910962|183003332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.299|TWO_SIDED|95.0|0.39|1.34|||Cox' proportional hazards model|||||1.34|0.39|0.2990
91557174|NCT00910962|183003332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.8235|TWO_SIDED|95.0|0.6|1.9|||Cox' proportional hazards model|||||1.90|0.60|0.8235
91557175|NCT00910962|183003332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.659|TWO_SIDED|95.0|0.52|1.51|||Cox' proportional hazards model|||||1.51|0.52|0.6590
91557176|NCT00910962|183003338|SUPERIORITY||test to reference ratio|0.8||||0.151|TWO_SIDED|95.0|0.59|1.09|||Repeated measures ANCOVA|||||1.09|0.59|0.151
91557177|NCT00910962|183003338|SUPERIORITY||test to reference ratio|0.95||||0.744|TWO_SIDED|95.0|0.7|1.29|||Repeated measures ANCOVA|||||1.29|0.70|0.744
91557178|NCT00910962|183003338|SUPERIORITY||test to treatment ratio|0.87||||0.317|TWO_SIDED|95.0|0.66|1.14|||Repeated measures ANCOVA|||||1.14|0.66|0.317
91557179|NCT00910962|183003339|SUPERIORITY||test to reference ratio|1.03||||0.83|TWO_SIDED|95.0|0.8|1.32|||ANCOVA|||||1.32|0.80|0.83
91557180|NCT00910962|183003339|SUPERIORITY||test to reference ratio|1.08||||0.56|TWO_SIDED|95.0|0.84|1.39|||ANCOVA|||||1.39|0.84|0.56
91557181|NCT00910962|183003339|SUPERIORITY||test to reference ratio|1.05||||0.65|TWO_SIDED|95.0|0.84|1.32|||ANCOVA|||||1.32|0.84|0.65
91557182|NCT00910962|183003340|SUPERIORITY||Test to reference ratio|0.77||||0.04|TWO_SIDED|95.0|0.6|0.99|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.99|0.60|0.040
91557183|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.85|0.52|0.001
91557184|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.71||||0.003|TWO_SIDED|95.0|0.57|0.89|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.89|0.57|0.003
91557185|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.78|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 48 hours||0.78|0.40|<0.001
91557186|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 48 hours||0.65|0.33|<0.001
91557187|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.51|||<|0.001|TWO_SIDED|95.0|0.38|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 48 hours||0.69|0.38|<0.001
91557188|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.68||||0.059|TWO_SIDED|95.0|0.45|1.01|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.01|0.45|0.059
91557189|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||0.90|0.40|0.013
91557190|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||0.92|0.45|0.015
91557191|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.7||||0.073|TWO_SIDED|95.0|0.48|1.03|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||1.03|0.48|0.073
91557192|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.7||||0.075|TWO_SIDED|95.0|0.48|1.04|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.04|0.48|0.075
91557193|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.7||||0.044|TWO_SIDED|95.0|0.5|0.99|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||0.99|0.50|0.044
91557194|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.78||||0.157|TWO_SIDED|95.0|0.55|1.1|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 4||1.10|0.55|0.157
91557195|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.9||||0.548|TWO_SIDED|95.0|0.63|1.28|||ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 4||1.28|0.63|0.548
91557196|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.83||||0.253|TWO_SIDED|95.0|0.61|1.14|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 4||1.14|0.61|0.253
91557197|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.8||||0.204|TWO_SIDED|95.0|0.58|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 8||1.13|0.58|0.204
91557198|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.99||||0.965|TWO_SIDED|95.0|0.71|1.39|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 8||1.39|0.71|0.965
91557199|NCT00910962|183003340|SUPERIORITY||test to reference ratio|0.89||||0.457|TWO_SIDED|95.0|0.66|1.2|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 8||1.20|0.66|0.457
91557200|NCT00910962|183003340|SUPERIORITY||test to reference ratio|1.58||||0.008|TWO_SIDED|95.0|1.13|2.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 14||2.22|1.13|0.008
91557201|NCT00910962|183003340|SUPERIORITY||test to reference ratio|1.69||||0.002|TWO_SIDED|95.0|1.21|2.38|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 14||2.38|1.21|0.002
91557202|NCT00910962|183003340|SUPERIORITY||test to reference ratio|1.64||||0.001|TWO_SIDED|95.0|1.21|2.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 14||2.21|1.21|0.001
91557203|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.43|0.69|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.69|0.43|<0.001
91557204|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.5|0.82|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.82|0.50|<0.001
91557205|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.48|0.73|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.73|0.48|<0.001
91557206|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.76||||0.031|TWO_SIDED|95.0|0.59|0.98|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||0.98|0.59|0.031
91557207|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.88||||0.315|TWO_SIDED|95.0|0.68|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.13|0.68|0.315
91557208|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.82||||0.075|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||1.02|0.65|0.075
91557209|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.81||||0.068|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||1.02|0.65|0.068
91557210|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.97||||0.824|TWO_SIDED|95.0|0.78|1.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.22|0.78|0.824
91557211|NCT00910962|183003341|SUPERIORITY||test to reference ratio|0.89||||0.246|TWO_SIDED|95.0|0.73|1.09|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||1.09|0.73|0.246
91557212|NCT00910962|183003342|SUPERIORITY||test to reference ratio|1.04||||0.66|TWO_SIDED|95.0|0.89|1.21|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.21|0.89|0.66
91557213|NCT00910962|183003342|SUPERIORITY||test to reference ratio|1.07||||0.39|TWO_SIDED|95.0|0.92|1.25|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||1.25|0.92|0.39
91557214|NCT00910962|183003342|SUPERIORITY||test to reference ratio|1.05||||0.47|TWO_SIDED|95.0|0.92|1.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||1.21|0.92|0.47
91557215|NCT00910962|183003343|SUPERIORITY||test to reference ratio|0.99||||0.92|TWO_SIDED|95.0|0.78|1.25|||Repeated measures ANCOVA|||||1.25|0.78|0.92
91557216|NCT00910962|183003343|SUPERIORITY||test to reference ratio|1.08||||0.52|TWO_SIDED|95.0|0.85|1.36|||Repeated measures ANCOVA|||||1.36|0.85|0.52
91557217|NCT00910962|183003343|SUPERIORITY||test to reference ratio|1.03||||0.76|TWO_SIDED|95.0|0.84|1.27|||Repeated measures ANCOVA|||||1.27|0.84|0.76
91557218|NCT00910962|183003344|SUPERIORITY||test to reference ratio|0.93||||0.57|TWO_SIDED|95.0|0.72|1.2|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For discharge/early withdrawal||1.20|0.72|0.57
91557219|NCT00910962|183003344|SUPERIORITY||test to reference ratio|0.92||||0.52|TWO_SIDED|95.0|0.72|1.18|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For discharge/early withdrawal||1.18|0.72|0.52
91557220|NCT00910962|183003344|SUPERIORITY||test to reference ratio|0.92||||0.5|TWO_SIDED|95.0|0.74|1.16|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For discharge/early withdrawal||1.16|0.74|0.50
91557221|NCT00910962|183003344|SUPERIORITY||test to reference ratio|0.73||||0.03|TWO_SIDED|95.0|0.55|0.96|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.96|0.55|0.03
91557222|NCT00910962|183003344|SUPERIORITY||test to reference ratio|0.81||||0.14|TWO_SIDED|95.0|0.61|1.07|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.07|0.61|0.14
91557223|NCT00910962|183003344|SUPERIORITY||test to reference ratio|0.76||||0.04|TWO_SIDED|95.0|0.6|0.98|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.98|0.60|0.04
91557224|NCT00910962|183003345|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.254|TWO_SIDED|95.0|-5.25|1.41|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Day 3-5 (visit 1)||1.41|-5.25|0.254
91557225|NCT00910962|183003345|SUPERIORITY||Mean Difference (Final Values)|-2.84||||0.106|TWO_SIDED|95.0|-6.29|0.62|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Day 3-5 (visit 1)||0.62|-6.29|0.106
91557226|NCT00910962|183003345|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.126|TWO_SIDED|95.0|-5.44|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Day 3-5 (visit 1)||0.69|-5.44|0.126
91557227|NCT00910962|183003345|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.184|TWO_SIDED|95.0|-4.74|0.92|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.92|-4.74|0.184
91557228|NCT00910962|183003345|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.093|TWO_SIDED|95.0|-5.37|0.43|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||0.43|-5.37|0.093
91557229|NCT00910962|183003345|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.096|TWO_SIDED|95.0|-4.78|0.4|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.40|-4.78|0.096
91557230|NCT00910962|183003346|SUPERIORITY||Mean Difference (Final Values)|4.22||||0.124|TWO_SIDED|95.0|-1.18|9.62|||Repeated measures ANCOVA|||||9.62|-1.18|0.124
91557231|NCT00910962|183003346|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.029|TWO_SIDED|95.0|0.63|11.47|||Repeated measures ANCOVA|||||11.47|0.63|0.029
91557232|NCT00910962|183003346|SUPERIORITY||Mean Difference (Final Values)|5.14||||0.039|TWO_SIDED|95.0|0.28|10.0|||Repeated measures ANCOVA|||||10.00|0.28|0.039
91557233|NCT00910962|183003347|SUPERIORITY||Mean Difference (Final Values)|-21.53||||0.025|TWO_SIDED|95.0|-40.27|-2.79|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVEDV||-2.79|-40.27|0.025
91557234|NCT00910962|183003347|SUPERIORITY||Mean Difference (Final Values)|-18.65||||0.053|TWO_SIDED|95.0|-37.58|0.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVEDV||0.29|-37.58|0.053
91557235|NCT00910962|183003347|SUPERIORITY||Mean Difference (Final Values)|-20.09||||0.021|TWO_SIDED|95.0|-37.01|-3.18|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVEDV||-3.18|-37.01|0.021
91557236|NCT00910962|183003347|SUPERIORITY||Mean Difference (Final Values)|-15.82||||0.024|TWO_SIDED|95.0|-29.51|-2.14|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVESV||-2.14|-29.51|0.024
91557237|NCT00910962|183003347|SUPERIORITY||Mean Difference (Final Values)|-17.22||||0.016|TWO_SIDED|95.0|-31.14|-3.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVESV||-3.29|-31.14|0.016
91557238|NCT00910962|183003347|SUPERIORITY||Mean Difference (Final Values)|-16.52||||0.01|TWO_SIDED|95.0|-28.91|-4.13|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVESV||-4.13|-28.91|0.010
91557239|NCT00910962|183003348|SUPERIORITY||Mean Difference (Final Values)|-22.21||||0.109|TWO_SIDED|95.0|-49.51|5.09|||Repeated measures ANCOVA|||||5.09|-49.51|0.109
91557240|NCT00910962|183003348|SUPERIORITY||Mean Difference (Final Values)|-7.13||||0.614|TWO_SIDED|95.0|-35.22|20.96|||Repeated measures ANCOVA|||||20.96|-35.22|0.614
91557241|NCT00910962|183003348|SUPERIORITY||Mean Difference (Final Values)|-14.67||||0.243|TWO_SIDED|95.0|-39.52|10.18|||Repeated measures ANCOVA|||||10.18|-39.52|0.243
91557242|NCT00910962|183003349|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.023|TWO_SIDED|95.0|-0.44|-0.03|||Repeated measures ANCOVA|||||-0.03|-0.44|0.023
91557243|NCT00910962|183003349|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Repeated measures ANCOVA|||||-0.04|-0.45|0.021
91557244|NCT00910962|183003349|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.011|TWO_SIDED|95.0|-0.42|-0.06|||Repeated measures ANCOVA|||||-0.06|-0.42|0.011
91557245|NCT00910962|183003350|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.137|TWO_SIDED|95.0|-0.26|0.04|||Repeated measures ANCOVA|||||0.04|-0.26|0.137
91557246|NCT00910962|183003350|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.036|TWO_SIDED|95.0|-0.32|-0.01|||Repeated measures ANCOVA|||||-0.01|-0.32|0.036
91557247|NCT00910962|183003350|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.047|TWO_SIDED|95.0|-0.28|0.0|||Repeated measures ANCOVA|||||-0.00|-0.28|0.047
91557248|NCT00195819|183003351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.1||||0.06||95.0|-0.5|40.7|||Chi-squared|||||40.7|-0.5|0.060
91557249|NCT00195819|183003394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.387||95.0|||||ANCOVA|||||||0.387
91557250|NCT05794191|183003410|SUPERIORITY||Vaccine effectiveness percentage|22.438|||||TWO_SIDED|95.0|5.425|36.391||||||||36.391|5.425|
91557251|NCT05794191|183003411|SUPERIORITY||Vaccine effectiveness percentage|34.985|||||TWO_SIDED|95.0|13.249|51.275||||||||51.275|13.249|
91557252|NCT05794191|183003412|SUPERIORITY||Vaccine effectiveness percentage|-5.284|||||TWO_SIDED|95.0|-50.408|26.302||||||||26.302|-50.408|
91557253|NCT05794191|183003413|SUPERIORITY||Vaccine effectiveness percentage|9.274|||||TWO_SIDED|95.0|-46.883|43.961||||||||43.961|-46.883|
91557254|NCT05794191|183003414|SUPERIORITY||Vaccine effectiveness percentage|17.169|||||TWO_SIDED|95.0|3.994|28.536||||||||28.536|3.994|
91557255|NCT05794191|183003415|SUPERIORITY||Vaccine effectiveness percentage|25.526|||||TWO_SIDED|95.0|9.4|38.781||||||||38.781|9.400|
91557256|NCT05794191|183003416|SUPERIORITY||Vaccine effectiveness percentage|-7.561|||||TWO_SIDED|95.0|-42.076|18.569||||||||18.569|-42.076|
91557257|NCT05794191|183003417|SUPERIORITY||Vaccine effectiveness percentage|11.442|||||TWO_SIDED|95.0|-34.916|41.871||||||||41.871|-34.916|
91557258|NCT05794191|183003418|SUPERIORITY||Vaccine effectiveness percentage|8.435|||||TWO_SIDED|95.0|5.705|11.086||||||||11.086|5.705|
91557259|NCT05794191|183003419|SUPERIORITY||Vaccine effectiveness percentage|11.445|||||TWO_SIDED|95.0|8.089|14.679||||||||14.679|8.089|
91557260|NCT05794191|183003420|SUPERIORITY||Vaccine effectiveness percentage|7.125|||||TWO_SIDED|95.0|1.427|12.493||||||||12.493|1.427|
91557261|NCT05794191|183003421|SUPERIORITY||Vaccine effectiveness percentage|-3.716|||||TWO_SIDED|95.0|-12.626|4.488||||||||4.488|-12.626|
91557262|NCT05794191|183003422|SUPERIORITY||Vaccine effectiveness percentage|13.685|||||TWO_SIDED|95.0|10.213|17.022||||||IPTW\*IPCW + imbalanced variables: 0-3 years||17.022|10.213|
91557263|NCT05794191|183003422|SUPERIORITY||Vaccine effectiveness percentage|7.665|||||TWO_SIDED|95.0|1.707|13.261||||||IPTW\*IPCW + imbalanced variables: 3-5 years||13.261|1.707|
91557264|NCT05794191|183003422|SUPERIORITY||Vaccine effectiveness percentage|-5.792|||||TWO_SIDED|95.0|-15.691|3.26||||||IPTW\*IPCW + imbalanced variables: 5-7 years||3.260|-15.691|
91557265|NCT05794191|183003422|SUPERIORITY||Vaccine effectiveness percentage|9.902|||||TWO_SIDED|95.0|7.056|12.66||||||IPTW\*IPCW + imbalanced variables: overall follow up||12.660|7.056|
91557266|NCT05794191|183003423|SUPERIORITY||Vaccine effectiveness percentage|13.631|||||TWO_SIDED|95.0|10.149|16.978||||||IPTW\*IPCW + imbalanced variables: 0-3 years||16.978|10.149|
91557267|NCT05794191|183003423|SUPERIORITY||Vaccine effectiveness percentage|7.673|||||TWO_SIDED|95.0|1.708|13.276||||||IPTW\*IPCW + imbalanced variables: 3-5 years||13.276|1.708|
91557268|NCT05794191|183003423|SUPERIORITY||Vaccine effectiveness percentage|-5.897|||||TWO_SIDED|95.0|-15.809|3.166||||||IPTW\*IPCW + imbalanced variables: 5-7 years||3.166|-15.809|
91557269|NCT05794191|183003423|SUPERIORITY||Vaccine effectiveness percentage|9.853|||||TWO_SIDED|95.0|7.0|12.617||||||IPTW\*IPCW + imbalanced variables: overall follow up||12.617|7.000|
91557270|NCT01079806|183003437|SUPERIORITY||Difference estimate|20.2||||0.0049|TWO_SIDED|95.0|9.1|31.4|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||31.4|9.1|0.0049
91557271|NCT01079806|183003438|SUPERIORITY||Difference estimate|41.8|||<|0.0001|TWO_SIDED|95.0|29.4|54.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||54.2|29.4|<0.0001
91557272|NCT01079806|183003439|SUPERIORITY||Difference estimate|45.2|||<|0.0001||95.0|29.2|61.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||61.2|29.2|<0.0001
91557273|NCT01079806|183003440|SUPERIORITY||Difference estimate|38.2|||<|0.0001|TWO_SIDED|95.0|25.9|50.5|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||50.5|25.9|<0.0001
91557274|NCT01079806|183003441|SUPERIORITY||Difference estimate|12.1||||0.11|TWO_SIDED|95.0|-1.5|25.7|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||25.7|-1.5|0.11
91557275|NCT03274076|183003473|SUPERIORITY||Rate ratio|1.25|||||TWO_SIDED|90.0|0.19|8.33|||||Tofacitinib represents the numerator, and placebo represents the denominator.|H0: Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Tofacitinib.||8.33|0.19|
91557276|NCT03274076|183003474|SUPERIORITY||Rate ratio|0.65|||||TWO_SIDED|90.0|0.25|1.71|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Tofacitinib||1.71|0.25|
91557277|NCT03274076|183003474|SUPERIORITY||Rate ratio|0.53|||||TWO_SIDED|90.0|0.26|1.07|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Tofacitinib||1.07|0.26|
91557278|NCT03274076|183003474|SUPERIORITY||Rate ratio|0.85|||||TWO_SIDED|90.0|0.49|1.49|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Tofacitinib||1.49|0.49|
91557279|NCT03274076|183003474|SUPERIORITY||Rate ratio|0.89|||||TWO_SIDED|90.0|0.52|1.52|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Tofacitinib||1.52|0.52|
91557280|NCT03274076|183003475|SUPERIORITY||Rate ratio|3.85|||||TWO_SIDED|90.0|0.68|21.77|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 36 in Placebo = Rate of adverse events of special interest throughout week 36 in Tofacitinib||21.77|0.68|
91557281|NCT03274076|183003475|SUPERIORITY||Rate ratio|1.87|||||TWO_SIDED|90.0|0.5169|6.7652|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 48 in Placebo = Rate of adverse events of special interest throughout week 48 in Tofacitinib||6.7652|0.5169|
91557282|NCT03274076|183003476|SUPERIORITY|||||||0.1978|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 12 in placebo = The absolute change in mRSS from week 0 to week 12 in Tofacitinib.||||0.1978
91557283|NCT03274076|183003476|SUPERIORITY|||||||0.4665|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 24 in placebo = The absolute change in mRSS from week 0 to week 24 in Tofacitinib.||||0.4665
91557284|NCT03274076|183003476|SUPERIORITY|||||||0.3063|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 36 in placebo = The absolute change in mRSS from week 0 to week 36 in Tofacitinib.||||0.3063
91557285|NCT03274076|183003476|SUPERIORITY|||||||0.6|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 48 in placebo = The absolute change in mRSS from week 0 to week 48 in Tofacitinib.||||0.6000
91557286|NCT03274076|183003477|SUPERIORITY|||||||0.4535|||||||Exact Wilcoxon|||H0: The CRISS score at week 12 in placebo = The CRISS score at week 12 in Tofacitinib.||||0.4535
91557287|NCT03274076|183003477|SUPERIORITY|||||||0.8392|||||||Exact Wilcoxon|||H0: The CRISS score at week 24 in placebo = The CRISS score at week 24 in Tofacitinib.||||0.8392
91557288|NCT03274076|183003477|SUPERIORITY|||||||0.9212|||||||Exact Wilcoxon|||H0: The CRISS score at week 48 in placebo = The CRISS score at week 48 in Tofacitinib.||||0.9212
91768495|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-37.2|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||37.2|-37.2|1.000
91768496|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|7.5||||1|TWO_SIDED|95.0|-31.6|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||46.6|-31.6|1.000
91557289|NCT02909959|183003495|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|3.03||0.331|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.331
91768497|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|32.5||||0.051|TWO_SIDED|95.0|1.4|63.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.6|1.4|0.051
91557290|NCT02909959|183003496|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.99||0.98|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.98
91557291|NCT02909959|183003497|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-0.774|STANDARD_ERROR_OF_MEAN|2.99||0.797|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.797
91557292|NCT02909959|183003498|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|3.01||0.442|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.442
91557293|NCT02909959|183003499|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.72|STANDARD_ERROR_OF_MEAN|3.05||0.373|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.373
91768498|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||34.8|-34.8|1.000
91557294|NCT00822900|183003564|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.35|TWO_SIDED|95.0|0.85|1.06|||Regression, Generalized linear|Adjusting for injury severity, sex, and age. the binomial distribution with the log link is used to estimate treatment effect as relative risk.|A risk ratio (equivalent to the relative risk) of less than 1.00 indicating fewer favorable outcomes in the progesterone group than in the placebo group.|Test of null hypothesis (equal proportions of subjects with favorable outcome in progesterone and placebo arms) versus alternative hypothesis (unequal proportions of subjects with favorable outcome in progesterone and placebo arms). Standard multiple imputation methods are used to account for missing data. The primary outcome measure is based on the stratified dichotomy approach.||1.06|0.85|0.35
91557295|NCT00822900|183003565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.86|1.63|||||A hazard ratio of more than 1.00 indicating higher hazard of death from the progesterone group than in the placebo group.|The Cox proportional hazards model is used to compare these curves after adjustment for age, sex and injury severity.||1.63|0.86|
91557296|NCT00822900|183003567|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.03|||||TWO_SIDED|95.0|1.96|4.66|||||A risk ratio (equivalent to the relative risk) of more than 1.00 indicating more events in the progesterone group than in the placebo group.|||4.66|1.96|
91557297|NCT01968967|183003586|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-58.3|-54.0|||MMRM|||Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-54.0|-58.3|<0.001
91557298|NCT01968967|183003587|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-36.5|-33.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.5|-36.5|<0.001
91557299|NCT01968967|183003587|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-33.3|-29.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-29.8|-33.3|
91557300|NCT01968967|183003587|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-26.6|-22.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.8|-26.6|
91557301|NCT01968967|183003588|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.8|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.9|-48.8|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.8|-52.9|<0.001
91557302|NCT01968967|183003588|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-48.5|-43.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.8|-48.5|
91557303|NCT01968967|183003588|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-38.6|-33.6||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.6|-38.6|
91557304|NCT01968967|183003589|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.1|-48.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-52.1|<0.001
91557305|NCT01968967|183003589|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|-47.9|-43.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.1|-47.9|
91557306|NCT01968967|183003589|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-38.5|-33.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.3|-38.5|
91557307|NCT01968967|183003590|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-60.2|-55.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.2|-60.2|<0.001
91557308|NCT01968967|183003590|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.1|STANDARD_ERROR_OF_MEAN|1.55|||TWO_SIDED|95.0|-56.1|-50.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-50.0|-56.1|
91557309|NCT01968967|183003590|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.8|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-46.2|-39.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-46.2|
91557310|NCT01968967|183003591|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-55.9|-47.7|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-47.7|-55.9|<0.001
91557311|NCT01968967|183003591|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-49.1|-38.8||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-38.8|-49.1|
91557312|NCT01968967|183003591|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-40.2|-29.0||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-29.0|-40.2|
91557313|NCT01968967|183003592|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-34.4|-22.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.5|-34.4|<0.001
91557314|NCT01968967|183003592|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-40.6|-21.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.5|-40.6|
91557315|NCT01968967|183003592|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-36.8|-13.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.7|-36.8|
91557316|NCT01968967|183003593|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.5|7.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.0|4.5|<0.001
91557317|NCT01968967|183003593|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|4.2|6.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.8|4.2|
91557318|NCT01968967|183003593|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|3.7|6.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.7|3.7|
91557319|NCT01968967|183003594|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.7|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-53.3|-48.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-53.3|
91557320|NCT01968967|183003594|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-43.5|-37.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-37.8|-43.5|
91557321|NCT01968967|183003595|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
91557322|NCT01968967|183003595|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
91557323|NCT01968967|183003595|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
91768499|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||60.0|-5.0|0.075
91557324|NCT01968967|183003596|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|2.4|4.3||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.3|2.4|
91557325|NCT01968967|183003596|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|2.5|4.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.5|2.5|
91557326|NCT01968967|183003596|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|2.7|4.9||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.9|2.7|
91557327|NCT01968967|183003597|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.9|1.4||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||1.4|-0.9|
91557328|NCT01968967|183003597|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-0.1|2.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.3|-0.1|
91557329|NCT01968967|183003597|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|0.3|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|0.3|
91557330|NCT01968967|183003598|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
91557331|NCT01968967|183003598|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
91557332|NCT01968967|183003598|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
91557333|NCT01968967|183003599|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-63.1|-57.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.6|-63.1|
91557334|NCT01968967|183003600|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.8|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-68.3|-57.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.3|-68.3|
91557335|NCT01968967|183003601|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.0|STANDARD_ERROR_OF_MEAN|1.27|||TWO_SIDED|95.0|-63.5|-58.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-58.5|-63.5|
91557336|NCT01968967|183003602|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-66.6|-60.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-60.9|-66.6|
91557337|NCT01968967|183003603|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-69.3|-63.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.6|-69.3|
91557338|NCT01968967|183003604|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-47.7|-43.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.9|-47.7|
91557339|NCT01968967|183003605|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-11.8|-9.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.3|-11.8|
91557340|NCT01968967|183003606|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|2.1|3.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.3|2.1|
91557341|NCT01968967|183003607|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-1.6|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.6|
91557342|NCT01968967|183003607|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.5|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.5|
91557343|NCT01968967|183003607|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.2|-1.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.0|-1.2|
91557344|NCT01968967|183003608|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
91557345|NCT01968967|183003608|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
91557346|NCT01968967|183003608|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.3|
91557347|NCT01968967|183003609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.0|||||TWO_SIDED|95.0|19.21|38.02||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||38.02|19.21|
91557348|NCT01968967|183003609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.9|||||TWO_SIDED|95.0|9.84|16.86||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||16.86|9.84|
91557349|NCT01968967|183003609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||||TWO_SIDED|95.0|4.99|8.06||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||8.06|4.99|
91557350|NCT01968967|183003610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.5|||||TWO_SIDED|95.0|61.74|121.25||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||121.25|61.74|
91557351|NCT01968967|183003610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.9|||||TWO_SIDED|95.0|26.83|47.96||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||47.96|26.83|
91557352|NCT01968967|183003610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.5|||||TWO_SIDED|95.0|18.9|34.47||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||34.47|18.90|
91557353|NCT03758742|183003665|SUPERIORITY||||||<|0.0001|||||||Binomial Test|||||||<0.0001
91557354|NCT03617835|183003699|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.67|||||TWO_SIDED|90.0|78.48|111.8|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||111.80|78.48|
91557355|NCT03617835|183003699|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.95|||||TWO_SIDED|90.0|117.26|167.03|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.03|117.26|
91557356|NCT03617835|183003700|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.84|||||TWO_SIDED|90.0|102.08|145.41|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.41|102.08|
91557357|NCT03617835|183003701|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|99.17|||||TWO_SIDED|90.0|83.77|117.39|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||117.39|83.77|
91557358|NCT03617835|183003701|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|156.2|||||TWO_SIDED|90.0|131.95|184.9|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||184.90|131.95|
91557359|NCT03617835|183003702|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|138.34|||||TWO_SIDED|90.0|116.87|163.77|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||163.77|116.87|
91557360|NCT03617835|183003703|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.58|||||TWO_SIDED|90.0|78.11|112.11|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||112.11|78.11|
91768500|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.2|-18.6|0.705
91557361|NCT03617835|183003703|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.73|||||TWO_SIDED|90.0|116.64|167.4|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.40|116.64|
91557362|NCT03617835|183003704|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.34|||||TWO_SIDED|90.0|101.28|145.37|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.37|101.28|
91557363|NCT02060487|183003710|NON_INFERIORITY|Non-inferiority of sildenafil 20 mg TID versus sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% confidence interval (CI) for hazard ratio (HR) was less than 2.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|99.7|0.31|1.49|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.49|0.31|
91768501|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.4|-20.0|1.000
91557364|NCT02060487|183003710|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% CI for HR was less than 2.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|99.7|0.22|1.21|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.22|
91557365|NCT02060487|183003710|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 20 mg TID was to be concluded if the upper limit of the 99.7% CI for HR is less than 2.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|99.7|0.3|1.84|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.84|0.30|
91557366|NCT02060487|183003711|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.035|TWO_SIDED|99.7|0.33|1.21|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.33|0.035
91557367|NCT02060487|183003711|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|99.7|0.22|0.89|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||0.89|0.22|<0.001
91557368|NCT02060487|183003711|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.195|TWO_SIDED|99.7|0.34|1.52|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.52|0.34|0.195
91557369|NCT02060487|183003712|SUPERIORITY||Least-squares means difference|15.0||||0.0627|TWO_SIDED|95.0|-0.8|30.81|||MMRM|||||30.81|-0.80|0.0627
91557370|NCT02060487|183003712|SUPERIORITY||Least-squares means difference|18.9||||0.0201|TWO_SIDED|95.0|2.99|34.86|||MMRM|||||34.86|2.99|0.0201
91557371|NCT02060487|183003712|SUPERIORITY||Least-squares means difference|3.9||||0.6254|TWO_SIDED|95.0|-11.85|19.68|||MMRM|||||19.68|-11.85|0.6254
91557372|NCT02060487|183003713|SUPERIORITY||Least-squares means difference|21.3||||0.0286|TWO_SIDED|95.0|2.25|40.45|||MMRM|||||40.45|2.25|0.0286
91768502|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||60.0|-5.0|0.075
91768503|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.2|-18.6|0.705
91557373|NCT02060487|183003713|SUPERIORITY||Least-squares means difference|20.5||||0.0364|TWO_SIDED|95.0|1.3|39.65|||MMRM|||||39.65|1.30|0.0364
91557374|NCT02060487|183003713|SUPERIORITY||Least-squares means difference|-0.9||||0.9283|TWO_SIDED|95.0|-19.94|18.19|||MMRM|||||18.19|-19.94|0.9283
91557375|NCT03387189|183003714|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|0.39||||0.031|TWO_SIDED|95.0|0.17|0.91|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||0.91|0.17|0.031
91557376|NCT03387189|183003715|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|1.46||||0.465|TWO_SIDED|95.0|0.53|4.03|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||4.03|0.53|0.465
91557377|NCT03387189|183003716|SUPERIORITY|alpha - 0.05|Mean Difference (Final Values)|-11.4||||0.01|TWO_SIDED|95.0|-20.4|-2.5|||t-test, 2 sided|||||-2.5|-20.4|0.01
91557378|NCT03387189|183003717|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-1.0||||0.75|TWO_SIDED|95.0|-76.0|5.5|||t-test, 2 sided|||||5.5|-76.0|0.75
91557379|NCT03387189|183003718|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||t-test, 2 sided|||||-0.1|-1.0|0.02
91557380|NCT03387189|183003721|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.116||||0.1|TWO_SIDED|95.0|-0.01|0.24|||Fisher Exact|||||0.24|-0.01|0.10
91557381|NCT03387189|183003723|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.028||||0.81|TWO_SIDED|95.0|-0.12|17.8|||Fisher Exact|||||17.8|-0.12|0.81
91557382|NCT03387189|183003724|SUPERIORITY|Alpha - 0.05|Risk Ratio (RR)|0.01||||1|TWO_SIDED|95.0|-0.11|0.13|||Fisher Exact|||||0.13|-0.11|1.0
91557383|NCT03697603|183003726|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0312|TWO_SIDED|95.0|-2.7|-0.1|||MMRM|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||-0.1|-2.7|0.0312
91557384|NCT03697603|183003726|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0089|TWO_SIDED|95.0|-3.0|-0.4|||MMRM|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||-0.4|-3.0|0.0089
91557385|NCT03697603|183003727|OTHER||Diff|5.5||||0.1964|TWO_SIDED|95.0|-2.8|13.8|||Chi-squared|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||13.8|-2.8|0.1964
91557386|NCT03697603|183003727|OTHER||Diff|5.5||||0.1969|TWO_SIDED|95.0|-2.8|13.7|||Chi-squared|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||13.7|-2.8|0.1969
91557387|NCT04218864|183003728|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Linear Mixed regression models (LMM) have been used to identify any difference between the intervention and the control groups over time with regards to the continuous outcomes. Group (intervention vs. control), a 5-category time (baseline, 6 week, 3 month, 6 month, 12 month) and group-by-time interaction are covariates in the model. A random subject intercept is used to account for clustering within subject.||||>0.05
91557388|NCT04218864|183003729|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
91557389|NCT04218864|183003730|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
91557390|NCT04218864|183003731|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for primary outcome.||||>0.05
91557391|NCT04218864|183003732|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical Analysis strategy is identical to that for primary outcome measure.||||>0.05
91557392|NCT02222493|183003740|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|95.0|-9.92|5.11||||||Score statistic method||5.11|-9.92|
91557393|NCT02222493|183003740|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|90.0|-8.75|4.02||||||Score statistic method||4.02|-8.75|
91557394|NCT02542943|183003879|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.13||||0.435|TWO_SIDED|95.0|-0.4|0.134||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.134|-0.400|0.4350
91557395|NCT02542943|183003879|SUPERIORITY_OR_OTHER||LS mean difference|0.07||||0.7605|TWO_SIDED|95.0|-0.192|0.34||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.340|-0.192|0.7605
91557396|NCT02542943|183003880|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.0873|TWO_SIDED|95.0|-0.445|0.031||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.031|-0.445|0.0873
91557397|NCT02542943|183003881|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.4921|TWO_SIDED|95.0|-0.27|0.13||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.130|-0.270|0.4921
91557398|NCT02542943|183003881|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.8728|TWO_SIDED|95.0|-0.183|0.216||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.216|-0.183|0.8728
91557399|NCT02542943|183003881|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.4003|TWO_SIDED|95.0|-0.287|0.115||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.115|-0.287|0.4003
91557400|NCT02542943|183003882|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8106|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8106
91557401|NCT02542943|183003882|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1656|TWO_SIDED|95.0|-5.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.1656
91557402|NCT02542943|183003882|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1419|TWO_SIDED|95.0|0.0|5.0|||Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.1419
91557403|NCT02542943|183003883|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5631|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.5631
91557404|NCT02542943|183003883|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8423|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8423
91557405|NCT02542943|183003883|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.439|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.4390
91557406|NCT02542943|183003884|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.517|TWO_SIDED|95.0|-0.611|0.308||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.308|-0.611|0.5170
91768504|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|0.5||||1|TWO_SIDED|95.0|-17.4|18.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||18.5|-17.4|1.000
91768505|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.8|-20.5|1.000
91768506|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-6.4||||0.348|TWO_SIDED|95.0|-18.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||5.2|-18.0|0.348
91768507|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||20.7|-13.4|0.686
91768508|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|7.5||||0.616|TWO_SIDED|95.0|-19.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||34.8|-19.8|0.616
91768509|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-6.6||||0.42|TWO_SIDED|95.0|-20.5|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.3|-20.5|0.420
91557407|NCT02542943|183003884|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4538|TWO_SIDED|95.0|-0.284|0.633||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.633|-0.284|0.4538
91768510|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||12.4|-20.0|1.000
91768511|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||21.8|-20.5|1.000
91768512|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||13.3|-14.4|1.000
91768513|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.7|-13.4|0.686
91768514|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|9.4||||0.555|TWO_SIDED|95.0|-21.9|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.6|-21.9|0.555
91768515|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-2.7||||0.83|TWO_SIDED|95.0|-27.2|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||21.8|-27.2|0.830
91557408|NCT02542943|183003884|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.1663|TWO_SIDED|95.0|-0.788|0.136||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.136|-0.788|0.1663
91557409|NCT02542943|183003885|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.7137|TWO_SIDED|95.0|-0.661|0.453||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.453|-0.661|0.7137
91557410|NCT02542943|183003885|SUPERIORITY_OR_OTHER||LS mean difference|0.1||||0.7353|TWO_SIDED|95.0|-0.46|0.651||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.651|-0.460|0.7353
91557411|NCT02542943|183003885|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4843|TWO_SIDED|95.0|-0.76|0.361||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.361|-0.760|0.4843
91557412|NCT02434328|183003925|NON_INFERIORITY|The noninferiority margin was 4 letters.|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-2.4|1.0||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-2.4|<0.0001
91557413|NCT02434328|183003926|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-2.8|0.5||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||0.5|-2.8|0.0003
91768516|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-36.0|0.518
91557414|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||0.0|-2.0|
91557415|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.2|0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||0.2|-2.2|
91557416|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.4|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.4|-2.4|
91557417|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.3|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||0.6|-2.3|
91557418|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-3.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||0.0|-3.0|
91768517|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|12.5||||0.428|TWO_SIDED|95.0|-18.6|43.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||43.6|-18.6|0.428
91557419|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-2.5|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||0.6|-2.5|
91557420|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.7|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||0.5|-2.7|
91557421|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-2.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||0.7|-2.5|
91557422|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.9|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||0.4|-2.9|
91557423|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-2.9|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||0.5|-2.9|
91557424|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-3.2|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||0.1|-3.2|
91557425|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.4|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.0|-2.4|
91557426|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.1|-2.5|
91557427|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.1|-2.5|
91557428|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.7|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.0|-2.7|
91768518|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|3.9||||0.757|TWO_SIDED|95.0|-20.7|28.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||28.4|-20.7|0.757
91557429|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.2|-2.5|
91557430|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.2|-2.5|
91557431|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.8|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.1|-2.8|
91557432|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||1.4|-2.5|
91557433|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||1.8|-2.1|
91768519|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|4.6||||0.745|TWO_SIDED|95.0|-23.2|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||32.4|-23.2|0.745
91557434|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||1.1|-2.9|
91557435|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.6|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||1.3|-2.6|
91557436|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-2.4|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||1.6|-2.4|
91557437|NCT02434328|183003931|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||1.6|-2.5|
91557438|NCT02434328|183003932|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.4|0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||0.3|-2.4|
91557439|NCT02434328|183003932|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.4|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||0.7|-2.4|
91557440|NCT02434328|183003933|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.5|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||0.4|-2.5|
91557441|NCT02434328|183003933|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.4|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.||Week 12 to Week 96|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|0.8|-2.4|
91557442|NCT02434328|183003934|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.4|-2.5|
91557443|NCT02434328|183003935|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.1|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.9|-5.1|
91557444|NCT02434328|183003935|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-9.5|1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.0|-9.5|
91557445|NCT02434328|183003935|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-10.5|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||0.3|-10.5|
91557446|NCT02434328|183003935|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-8.4|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.7|-8.4|
91557447|NCT02434328|183003935|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.8|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-8.8|
91557448|NCT02434328|183003935|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.7|-5.2|
91557449|NCT02434328|183003935|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.9|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-9.9|
91557450|NCT02434328|183003935|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.5|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.7|-10.5|
91557451|NCT02434328|183003935|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-11.6|
91557452|NCT02434328|183003935|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-11.5|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-11.5|
91557453|NCT02434328|183003935|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.3|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||1.8|-11.3|
91557454|NCT02434328|183003935|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.1|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.8|-7.1|
91557455|NCT02434328|183003935|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.0|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.5|-7.0|
91557456|NCT02434328|183003935|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.7|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.4|-7.7|
91557457|NCT02434328|183003935|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-8.3|
91557458|NCT02434328|183003935|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.9|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-7.9|
91557459|NCT02434328|183003935|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.1|-9.9|
91557460|NCT02434328|183003935|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-10.2|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.3|-10.2|
91557461|NCT02434328|183003935|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.0|-8.8|
91557462|NCT02434328|183003935|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.0|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.5|-9.0|
91768520|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.8||||1|TWO_SIDED|95.0|-34.6|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.0|-34.6|1.000
91557463|NCT02434328|183003935|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.8|-9.9|
91557464|NCT02434328|183003935|OTHER||Difference in proportions|-5.8|||||TWO_SIDED|95.0|-11.8|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.3|-11.8|
91557465|NCT02434328|183003935|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.5|-7.9|
91557466|NCT02434328|183003935|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.8|
91557467|NCT02434328|183003936|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.8|-7.6|
91557468|NCT02434328|183003936|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-13.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||0.1|-13.0|
91557469|NCT02434328|183003936|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-10.1|
91557470|NCT02434328|183003936|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.3|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.3|-7.3|
91557471|NCT02434328|183003936|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.2|-11.2|
91557472|NCT02434328|183003936|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.0|-10.7|
91557473|NCT02434328|183003936|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.6|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.0|-9.6|
91768521|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|3.6||||0.773|TWO_SIDED|95.0|-20.6|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||27.7|-20.6|0.773
91768522|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-29.4|0.838
91557474|NCT02434328|183003936|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-9.4|
91557475|NCT02434328|183003936|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.1|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.1|-12.1|
91768523|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-12.9||||0.497|TWO_SIDED|95.0|-40.0|14.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||14.1|-40.0|0.497
91557476|NCT02434328|183003936|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.9|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.5|-9.9|
91768524|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||34.9|-14.0|0.404
91768525|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.8|-29.4|0.838
91557477|NCT02434328|183003936|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-10.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-10.3|
91557478|NCT02434328|183003936|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.7|-8.7|
91557479|NCT02434328|183003936|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
91557480|NCT02434328|183003936|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.3|-9.8|
91557481|NCT02434328|183003936|OTHER|Hypothesis testing not pre-specified.|Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.6|4.2|||Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-9.6|
91557482|NCT02434328|183003936|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.8|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-8.8|
91557483|NCT02434328|183003936|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.0|-8.4|
91557484|NCT02434328|183003936|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.4|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.9|-10.4|
91557485|NCT02434328|183003936|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.5|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-6.5|
91557486|NCT02434328|183003936|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.5|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-7.5|
91557487|NCT02434328|183003936|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.1|-10.4|
91557488|NCT02434328|183003936|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-9.6|
91557489|NCT02434328|183003936|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.0|
91557490|NCT02434328|183003936|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.0|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||6.8|-7.0|
91557491|NCT02434328|183003937|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-10.4|
91557492|NCT02434328|183003937|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.2|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-10.2|
91557493|NCT02434328|183003937|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.3|-10.7|
91557494|NCT02434328|183003937|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.4|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.7|-8.4|
91557495|NCT02434328|183003937|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-12.3|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||1.5|-12.3|
91557496|NCT02434328|183003937|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.7|-9.9|
91557497|NCT02434328|183003937|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.8|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.7|-12.8|
91557498|NCT02434328|183003937|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.2|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.8|-8.2|
91557499|NCT02434328|183003937|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-9.2|
91557500|NCT02434328|183003937|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.2|
91557501|NCT02434328|183003937|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-8.5|
91557502|NCT02434328|183003937|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.4|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.4|
91557503|NCT02434328|183003937|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-9.8|
91768526|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|3.6||||1|TWO_SIDED|95.0|-24.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||31.6|-24.4|1.000
91557504|NCT02434328|183003937|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.8|-8.6|
91557505|NCT02434328|183003937|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.1|-7.8|
91557506|NCT02434328|183003937|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||9.2|-4.5|
91557507|NCT02434328|183003937|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.6|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-8.6|
91557508|NCT02434328|183003937|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-5.8|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||7.5|-5.8|
91768527|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|16.4||||0.174|TWO_SIDED|95.0|-7.0|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.8|-7.0|0.174
91557509|NCT02434328|183003937|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-5.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.4|-5.1|
91557510|NCT02434328|183003937|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.8|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.9|-2.8|
91557511|NCT02434328|183003937|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.3|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-9.3|
91557512|NCT02434328|183003937|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||7.7|-6.1|
91557513|NCT02434328|183003937|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.0|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||10.4|-3.0|
91557514|NCT02434328|183003937|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||10.0|-3.9|
91557515|NCT02434328|183003938|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.4|-1.6|
91557516|NCT02434328|183003938|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.1|-2.3|
91557517|NCT02434328|183003938|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.|Week 12||2.2|-1.9|
91557518|NCT02434328|183003938|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.1|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.3|-2.1|
91557519|NCT02434328|183003938|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-2.0|
91557520|NCT02434328|183003938|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.2|-3.0|
91557521|NCT02434328|183003938|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-3.0|
91557522|NCT02434328|183003938|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.5|-3.2|
91557523|NCT02434328|183003938|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-2.3|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.3|-2.3|
91557524|NCT02434328|183003938|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-1.7|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.6|-1.7|
91557525|NCT02434328|183003938|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-2.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.4|-2.7|
91557526|NCT02434328|183003938|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-3.9|
91557527|NCT02434328|183003938|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.3|-4.3|
91557528|NCT02434328|183003938|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.8|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.9|-2.8|
91557529|NCT02434328|183003938|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-2.5|
91557530|NCT02434328|183003938|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.5|-2.7|
91557531|NCT02434328|183003938|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.2|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.6|-4.2|
91557532|NCT02434328|183003938|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-2.5|
91557533|NCT02434328|183003938|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.4|-2.5|
91557534|NCT02434328|183003938|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.6|-2.4|
91557535|NCT02434328|183003938|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-3.1|
91557536|NCT02434328|183003938|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-3.5|
91557537|NCT02434328|183003938|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.3|-3.8|
91557538|NCT02434328|183003938|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.3|-3.8|
91557539|NCT02434328|183003939|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.6|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-2.6|
91557540|NCT02434328|183003939|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.1|-2.2|
91557541|NCT02434328|183003939|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-2.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-2.8|
91557542|NCT02434328|183003939|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-4.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.7|-4.4|
91557543|NCT02434328|183003939|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.9|-1.7|
91557544|NCT02434328|183003939|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.8|-3.9|
91557545|NCT02434328|183003939|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.8|-3.2|
91557546|NCT02434328|183003939|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-3.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-3.8|
91557547|NCT02434328|183003939|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.0|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-3.0|
91557548|NCT02434328|183003939|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.1|-2.4|
91557549|NCT02434328|183003939|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-1.1|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.5|-1.1|
91557550|NCT02434328|183003939|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.3|-4.0|
91557551|NCT02434328|183003939|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.7|-2.8|
91557552|NCT02434328|183003939|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.8|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.5|-2.8|
91557553|NCT02434328|183003939|OTHER||Difference of proportions|1.0|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.7|-2.6|
91768528|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|6.6||||0.611|TWO_SIDED|95.0|-19.1|32.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||32.3|-19.1|0.611
91557554|NCT02434328|183003939|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.3|-4.0|
91557555|NCT02434328|183003939|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.6|-4.2|
91557556|NCT02434328|183003939|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.7|-4.0|
91768529|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
91557557|NCT02434328|183003939|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.7|-3.5|
91557558|NCT02434328|183003939|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.4|-4.5|
91557559|NCT02434328|183003939|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.6|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-3.6|
91557560|NCT02434328|183003939|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-4.5|
91557561|NCT02434328|183003939|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-5.7|
91557562|NCT02434328|183003939|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.2|-4.9|
91557563|NCT02434328|183003940|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-3.5|
91557564|NCT02434328|183003940|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.4|-4.4|
91557565|NCT02434328|183003940|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.1|-5.0|
91557566|NCT02434328|183003940|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-1.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.2|-1.9|
91557567|NCT02434328|183003940|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-0.4|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.8|-0.4|
91557568|NCT02434328|183003940|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Number of subjects with \>=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24||7.8|-1.3|
91557569|NCT02434328|183003940|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.7|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.3|-1.7|
91557570|NCT02434328|183003940|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-3.2|
91557571|NCT02434328|183003940|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.7|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.3|-0.7|
91557572|NCT02434328|183003940|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-3.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-3.8|
91557573|NCT02434328|183003940|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.0|-1.4|
91557574|NCT02434328|183003940|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.7|-5.1|
91557575|NCT02434328|183003940|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.5|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.7|-2.5|
91557576|NCT02434328|183003940|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.4|-2.8|
91557577|NCT02434328|183003940|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.6|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.8|-3.6|
91557578|NCT02434328|183003940|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.0|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-4.0|
91557579|NCT02434328|183003940|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.4|-2.8|
91557580|NCT02434328|183003940|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.3|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.7|-4.3|
91557581|NCT02434328|183003940|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.8|-4.4|
91557582|NCT02434328|183003940|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.0|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.6|-6.0|
91557583|NCT02434328|183003940|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-5.2|
91557584|NCT02434328|183003940|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-5.7|
91557585|NCT02434328|183003940|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.4|-6.5|
91557586|NCT02434328|183003940|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.1|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.8|-5.1|
91557587|NCT02434328|183003941|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.2|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-9.2|
91768530|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|0.488
91557588|NCT02434328|183003941|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-8.1|
91557589|NCT02434328|183003941|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.5|-8.4|
91557590|NCT02434328|183003941|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.7|-5.4|
91557591|NCT02434328|183003941|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.2|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.0|-8.2|
91557592|NCT02434328|183003941|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.3|-9.0|
91557593|NCT02434328|183003941|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.3|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-9.3|
91557594|NCT02434328|183003941|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.6|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.8|-9.6|
91557595|NCT02434328|183003941|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.6|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||2.2|-9.6|
91557596|NCT02434328|183003941|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.6|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.2|-7.6|
91557597|NCT02434328|183003941|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-7.5|
91557598|NCT02434328|183003941|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-5.4|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-5.4|
91557599|NCT02434328|183003941|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-7.7|
91557600|NCT02434328|183003941|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-7.7|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.0|-7.7|
91557601|NCT02434328|183003941|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.8|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.4|-10.8|
91768531|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
91768532|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
91557602|NCT02434328|183003941|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||3.2|-8.9|
91557603|NCT02434328|183003941|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.5|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.9|-9.5|
91557604|NCT02434328|183003941|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-7.9|
91557605|NCT02434328|183003941|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.1|-8.1|
91557606|NCT02434328|183003941|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.6|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-5.6|
91557607|NCT02434328|183003941|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.3|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.8|-8.3|
91557608|NCT02434328|183003941|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-7.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.5|-7.4|
91557609|NCT02434328|183003941|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.8|-6.5|
91557610|NCT02434328|183003941|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.1|
91557611|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-17.7|STANDARD_ERROR_OF_MEAN|7.57|||TWO_SIDED|95.0|-32.6|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-2.9|-32.6|
91557612|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|8.18|||TWO_SIDED|95.0|-45.6|-13.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-13.4|-45.6|
91557613|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-46.9|-13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-13.7|-46.9|
91768533|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|0.488
91557614|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|9.51|||TWO_SIDED|95.0|-58.9|-21.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-21.6|-58.9|
91557615|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|9.12|||TWO_SIDED|95.0|-20.9|15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||15.0|-20.9|
91557616|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-47.8|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|-66.3|-29.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-29.3|-66.3|
91557617|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||-5.4|-42.0|
91557618|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-33.7|STANDARD_ERROR_OF_MEAN|9.54|||TWO_SIDED|95.0|-52.4|-15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-15.0|-52.4|
91557619|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|8.94|||TWO_SIDED|95.0|-48.0|-12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-12.9|-48.0|
91557620|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-44.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|95.0|-63.5|-25.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-25.9|-63.5|
91557621|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-19.2|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-37.3|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||-1.1|-37.3|
91768534|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
91768535|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
91768536|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.0|-13.4|1.000
91768537|NCT02365649|183425713|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
91557622|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-49.9|STANDARD_ERROR_OF_MEAN|9.68|||TWO_SIDED|95.0|-68.9|-30.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-30.9|-68.9|
91557623|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|9.01|||TWO_SIDED|95.0|-45.8|-10.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||-10.4|-45.8|
91557624|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-43.1|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-62.4|-23.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-23.7|-62.4|
91557625|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-49.5|-12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||-12.8|-49.5|
91557626|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-64.9|-26.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-26.8|-64.9|
91557627|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.31|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||-5.4|-42.0|
91557628|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|9.69|||TWO_SIDED|95.0|-66.4|-28.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-28.3|-66.4|
91557629|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-28.0|STANDARD_ERROR_OF_MEAN|9.43|||TWO_SIDED|95.0|-46.5|-9.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||-9.5|-46.5|
91557630|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-40.9|STANDARD_ERROR_OF_MEAN|9.94|||TWO_SIDED|95.0|-60.4|-21.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-21.4|-60.4|
91557631|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|9.48|||TWO_SIDED|95.0|-49.6|-12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||-12.4|-49.6|
91557632|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-61.9|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-23.3|-61.9|
91557633|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-47.9|-10.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||-10.3|-47.9|
91557634|NCT02434328|183003942|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.87|||TWO_SIDED|95.0|-62.0|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-23.3|-62.0|
91557635|NCT02434328|183003943|OTHER|Treatment difference|Least Squares Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-54.0|-18.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-18.1|-54.0|
91557636|NCT02434328|183003944|OTHER|Treatment difference|Least Squares Mean Difference|-36.3|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-55.1|-17.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-17.6|-55.1|
91557637|NCT02434328|183003945|OTHER|Treatment difference|Least Squares Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|8.53|||TWO_SIDED|95.0|-47.6|-14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-14.1|-47.6|
91557638|NCT02434328|183003945|OTHER|Treatment difference|Least Squares Mean Difference|-33.5|STANDARD_ERROR_OF_MEAN|8.84|||TWO_SIDED|95.0|-50.8|-16.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-16.1|-50.8|
91557639|NCT02434328|183003946|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.0|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.7|0.0|
91557640|NCT02434328|183003946|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.1|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.6|-0.1|
91557641|NCT02434328|183003946|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.0|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||0.6|0.0|
91557642|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-11.6|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||7.3|-11.6|
91557643|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-13.6|6.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||6.0|-13.6|
91557644|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-14.3|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||5.3|-14.3|
91557645|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-13.7|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.4|-13.7|
91557646|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|95.0|-5.5|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||14.6|-5.5|
91557647|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-16.3|4.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||4.7|-16.3|
91557648|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|95.0|-13.1|7.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||7.0|-13.1|
91557649|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-12.6|8.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||8.5|-12.6|
91557650|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-15.2|5.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||5.1|-15.2|
91557651|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-17.0|3.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||3.8|-17.0|
91557652|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.4|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.9|-13.4|
91557653|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||3.7|-17.6|
91557654|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-12.9|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||7.5|-12.9|
91557655|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-15.4|5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||5.4|-15.4|
91557656|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-14.3|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||5.9|-14.3|
91557657|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.2|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||6.4|-14.2|
91557658|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.17|||TWO_SIDED|95.0|-10.7|9.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||9.6|-10.7|
91557659|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.8|5.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||5.7|-14.8|
91557660|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.23|||TWO_SIDED|95.0|-13.1|7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||7.4|-13.1|
91557661|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.33|||TWO_SIDED|95.0|-14.1|6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||6.8|-14.1|
91557662|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-13.5|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||7.3|-13.5|
91557663|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|-14.6|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||6.5|-14.6|
91557664|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|95.0|-12.6|8.0|||ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||8.0|-12.6|
91557665|NCT02434328|183003947|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.6|7.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||7.7|-13.6|
91557666|NCT02434328|183003948|OTHER||Difference in proportions|-6.6|||||TWO_SIDED|95.0|-13.2|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-13.2|
91557667|NCT02434328|183003948|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.8|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-3.0|-13.8|
91557668|NCT02434328|183003948|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.2|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.7|-12.2|
91557669|NCT02434328|183003948|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-20.8|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-8.3|-20.8|
91557670|NCT02434328|183003948|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-2.9|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.6|-2.9|
91557671|NCT02434328|183003948|OTHER||Difference in proportions|-19.2|||||TWO_SIDED|95.0|-25.5|-13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.0|-25.5|
91768538|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||45.5|-72.2|1.000
91557672|NCT02434328|183003948|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.6|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||-0.4|-11.6|
91557673|NCT02434328|183003948|OTHER||Difference in proportions|-9.8|||||TWO_SIDED|95.0|-16.5|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.5|-16.5|
91557674|NCT02434328|183003948|OTHER||Difference in proportions|-8.0|||||TWO_SIDED|95.0|-13.6|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.5|-13.6|
91768539|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.1|-50.2|1.000
91557675|NCT02434328|183003948|OTHER||Difference in proportions|-15.4|||||TWO_SIDED|95.0|-21.5|-9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.4|-21.5|
91557676|NCT02434328|183003948|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-3.2|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.4|-3.2|
91557677|NCT02434328|183003948|OTHER||Difference in proportions|-15.9|||||TWO_SIDED|95.0|-22.4|-10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-10.4|-22.4|
91557678|NCT02434328|183003948|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.1|-8.5|
91557679|NCT02434328|183003948|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-15.7|-2.9|||Regression, Logistic|Hypothesis testing not pre-specified.|Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.9|-15.7|
91768540|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||44.8|-4.8|1.000
91768541|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-23.3||||0.423|TWO_SIDED|95.0|-79.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||33.2|-79.8|0.423
91768542|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-32.9||||0.25|TWO_SIDED|95.0|-74.0|8.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||8.2|-74.0|0.250
91557680|NCT02434328|183003948|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-9.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.2|-9.8|
91557681|NCT02434328|183003948|OTHER||Difference in proportions|-15.1|||||TWO_SIDED|95.0|-21.3|-8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.4|-21.3|
91557682|NCT02434328|183003948|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.1|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.2|-6.1|
91557683|NCT02434328|183003948|OTHER||Difference in proportions|-16.6|||||TWO_SIDED|95.0|-22.6|-10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-10.5|-22.6|
91557684|NCT02434328|183003948|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.1|-7.0|
91768543|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-8.6|28.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.6|-8.6|1.000
91557685|NCT02434328|183003948|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-17.4|-5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-5.0|-17.4|
91557686|NCT02434328|183003948|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-11.3|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.7|-11.3|
91557687|NCT02434328|183003948|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-18.9|-5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-5.9|-18.9|
91557688|NCT02434328|183003948|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.0|-11.4|
91557689|NCT02434328|183003948|OTHER||Difference in proportions|-14.5|||||TWO_SIDED|95.0|-20.3|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-8.3|-20.3|
91557690|NCT02434328|183003949|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.4|-2.5|
91557691|NCT02434328|183003949|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.1|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.7|-6.1|
91768544|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.8|-4.8|1.000
91557692|NCT02434328|183003949|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-5.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-5.3|
91768545|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||33.1|-50.2|1.000
91557693|NCT02434328|183003949|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.4|-4.5|
91557694|NCT02434328|183003949|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|3.9|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.8|3.9|
91557695|NCT02434328|183003949|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-7.9|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.2|-7.9|
91557696|NCT02434328|183003949|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.4|-1.0|
91557697|NCT02434328|183003949|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-5.5|
91557698|NCT02434328|183003949|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.6|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.8|-5.6|
91768546|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||45.5|-72.2|1.000
91557699|NCT02434328|183003949|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.1|-6.0|
91557700|NCT02434328|183003949|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.5|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.0|-0.5|
91557701|NCT02434328|183003949|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-6.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-6.2|
91557702|NCT02434328|183003949|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.5|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.1|-2.5|
91557703|NCT02434328|183003949|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.1|-5.9|
91557704|NCT02434328|183003949|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.4|-4.4|
91557705|NCT02434328|183003949|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-6.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.1|-6.2|
91557706|NCT02434328|183003949|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.5|-1.2|
91557707|NCT02434328|183003949|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-4.2|
91557708|NCT02434328|183003949|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.5|
91768547|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-46.7||||0.203|TWO_SIDED|95.0|-100.0|12.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||12.2|-100.0|0.203
91768548|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||33.1|-50.2|1.000
91768549|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||45.5|-72.2|1.000
91768550|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
91557709|NCT02434328|183003949|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-4.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.3|-4.8|
91768551|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|11.4||||1|TWO_SIDED|95.0|-33.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||56.6|-33.8|1.000
91768552|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
91557710|NCT02434328|183003949|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.3|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.2|-3.3|
91557711|NCT02434328|183003949|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.5|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-4.5|
91557712|NCT02434328|183003949|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.1|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-0.1|
91557713|NCT02434328|183003949|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-4.3|
91557714|NCT02434328|183003950|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-8.9|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.5|-8.9|
91557715|NCT02434328|183003950|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-7.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.5|-7.6|
91557716|NCT02434328|183003950|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.7|-6.9|
91557717|NCT02434328|183003950|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.0|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.7|-13.0|
91768553|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
91768554|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
91557718|NCT02434328|183003950|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.6|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.2|-3.6|
91557719|NCT02434328|183003950|OTHER||Difference in proportions|-7.9|||||TWO_SIDED|95.0|-12.6|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-12.6|
91557720|NCT02434328|183003950|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.8|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.7|-6.8|
91557721|NCT02434328|183003950|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-0.3|-10.5|
91557722|NCT02434328|183003950|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.3|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.4|-10.3|
91557723|NCT02434328|183003950|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.2|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.5|-11.2|
91768555|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
91557724|NCT02434328|183003950|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.6|-4.8|
91557725|NCT02434328|183003950|OTHER||Difference in proportions|-9.1|||||TWO_SIDED|95.0|-13.8|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.9|-13.8|
91557726|NCT02434328|183003950|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.1|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.5|-7.1|
91557727|NCT02434328|183003950|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.1|-11.1|
91557728|NCT02434328|183003950|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-10.9|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.5|-10.9|
91557729|NCT02434328|183003950|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.9|0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.6|-10.9|
91557730|NCT02434328|183003950|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.0|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||-0.1|-11.0|
91557731|NCT02434328|183003950|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.5|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.2|-12.5|
91557732|NCT02434328|183003950|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.3|-10.7|
91768556|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
91768557|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||70.8|-100.0|1.000
91557733|NCT02434328|183003950|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-12.4|-0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.9|-12.4|
91557734|NCT02434328|183003950|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-7.0|
91557735|NCT02434328|183003950|OTHER||Difference in proportions|-4.8|||||TWO_SIDED|95.0|-10.5|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||1.3|-10.5|
91557736|NCT02434328|183003950|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.4|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.5|-11.4|
91557737|NCT02434328|183003950|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.3|-11.5|
91768558|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
91557738|NCT02434328|183003951|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.2|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.2|
91557739|NCT02434328|183003951|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-15.5|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.5|-15.5|
91557740|NCT02434328|183003951|OTHER||Difference in proportions|-8.7|||||TWO_SIDED|95.0|-15.0|-2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.6|-15.0|
91557741|NCT02434328|183003951|OTHER||Difference in proportions|-15.7|||||TWO_SIDED|95.0|-22.9|-9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-9.0|-22.9|
91557742|NCT02434328|183003951|OTHER||Difference in proportions|7.7|||||TWO_SIDED|95.0|0.9|14.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||14.8|0.9|
91557743|NCT02434328|183003951|OTHER||Difference in proportions|-20.0|||||TWO_SIDED|95.0|-27.3|-13.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.1|-27.3|
91557744|NCT02434328|183003951|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-10.4|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.4|-10.4|
91557745|NCT02434328|183003951|OTHER||Difference in proportions|-9.7|||||TWO_SIDED|95.0|-16.7|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-2.5|-16.7|
91557746|NCT02434328|183003951|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-15.8|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-3.4|-15.8|
91557747|NCT02434328|183003951|OTHER||Difference in proportions|-16.5|||||TWO_SIDED|95.0|-23.4|-9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.6|-23.4|
91557748|NCT02434328|183003951|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.3|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||10.4|-3.3|
91557749|NCT02434328|183003951|OTHER||Difference in proportions|-18.1|||||TWO_SIDED|95.0|-24.9|-11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-11.8|-24.9|
91557750|NCT02434328|183003951|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-9.2|
91557751|NCT02434328|183003951|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.3|-2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.8|-16.3|
91557752|NCT02434328|183003951|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-12.5|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.1|-12.5|
91557753|NCT02434328|183003951|OTHER||Difference in proportions|-15.5|||||TWO_SIDED|95.0|-21.9|-8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.5|-21.9|
91557754|NCT02434328|183003951|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.5|-5.9|
91557755|NCT02434328|183003951|OTHER||Difference in proportions|-14.9|||||TWO_SIDED|95.0|-21.4|-8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-8.1|-21.4|
91768559|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-100.0|42.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||42.1|-100.0|1.000
91557756|NCT02434328|183003951|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.4|-7.5|
91557757|NCT02434328|183003951|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-17.2|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-3.4|-17.2|
91557758|NCT02434328|183003951|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.4|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.3|-11.4|
91557759|NCT02434328|183003951|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-18.2|-4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-4.1|-18.2|
91557760|NCT02434328|183003951|OTHER||Difference in proportions|-2.9|||||TWO_SIDED|95.0|-9.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.5|-9.4|
91557761|NCT02434328|183003951|OTHER||Difference in proportions|-14.1|||||TWO_SIDED|95.0|-21.3|-7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-7.2|-21.3|
91557762|NCT03137459|183003960|SUPERIORITY||Risk Difference (RD)|0.059|||||TWO_SIDED|95.0|0.014|0.105|||||Analysis performed using GEE to account for clustering of participants within practices.|||.105|.014|
91557763|NCT03137459|183003960|SUPERIORITY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.14|2.93|||||Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior|||2.93|1.14|
91557764|NCT03137459|183003961|SUPERIORITY||Risk Difference (RD)|0.082|||||TWO_SIDED|95.0|0.014|0.15|||||Adjusted for clustering|||.150|.014|
91557765|NCT03137459|183003961|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.96|2.0|||||Accounting for clustering and adjusted for covariates as described in primary outcome|||2.0|.96|
91768560|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
91768561|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
91768562|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||75.4|-75.4|1.000
91557766|NCT03137459|183003962|SUPERIORITY||Risk Difference (RD)|0.133|||||TWO_SIDED|95.0|0.066|0.201|||||Accounting for clustering|||.201|.066|
91557767|NCT03137459|183003962|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.22|2.47|||||Accounting for clustering and adjusted for covariates as presenting for primary outcome|||2.47|1.22|
91557768|NCT03137459|183003963|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.05|0.188||||||||.188|-.05|
91557769|NCT03137459|183003963|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.72|1.85|||||Accounting for clustering and adjusting for covariates as described for primary outcome|||1.85|.72|
91557770|NCT02962284|183004058|SUPERIORITY||||||>|0.1|||||||ANCOVA|||||||>0.1
91557771|NCT01009645|183004112|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.||||<0.05
91557772|NCT01009645|183004112|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.||||<0.05
91557773|NCT01009645|183004112|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.||||<0.05
91557774|NCT01009645|183004113|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||ANOVA|used Scheffe's post-hoc analysis||||||<0.05
91557775|NCT05553366|183004118|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
91557776|NCT05553366|183004119|SUPERIORITY|||||||0.0016|||||||ANCOVA|||||||0.0016
91557777|NCT05553366|183004120|SUPERIORITY|||||||0.0016|||||||Log Rank|||||||0.0016
91557778|NCT05553366|183004121|SUPERIORITY|||||||0.1315|||||||Log Rank|||||||0.1315
91557779|NCT05553366|183004122|SUPERIORITY|||||||0.0343|||||||Cochran-Mantel-Haenszel|||||||0.0343
91557780|NCT05553366|183004123|SUPERIORITY|||||||0.0014|||||||Pearson's chi-squared test|||||||0.0014
91557781|NCT05553366|183004124|SUPERIORITY|||||||0.0032|||||||ANCOVA|||||||0.0032
91557782|NCT05553366|183004125|SUPERIORITY|||||||0.8592|||||||Log Rank|||||||0.8592
91557783|NCT05553366|183004126|SUPERIORITY|||||||0.9143|||||||Cochran-Mantel-Haenszel|||||||0.9143
91557784|NCT05553366|183004127|SUPERIORITY|||||||0.0205|||||||Wilcoxon rank-sum|||||||0.0205
91557785|NCT00659373|183004270|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.71
91557786|NCT00087022|183004291|SUPERIORITY|||||||0.737|||||||Log Rank|||||||0.737
91557787|NCT00087022|183004292|SUPERIORITY|||||||1.012|||||||Log Rank|||||||1.012
91557788|NCT00087022|183004295|SUPERIORITY|||||||0.022|||||||Log Rank|||||||0.022
91557789|NCT04399837|183004312|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.041||||0.002|||||||MCP-Mod linear model fit|Model assumption: Dose effect is linear with the increase of dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
91557790|NCT04399837|183004312|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.033||||0.002|||||||MCP-Mod Emax2 model fit|Model assumption: 95% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
91557791|NCT04399837|183004312|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.088||||0.002|||||||MCP-Mod Emax1 model fit|Model assumption: 70% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
91557792|NCT04399837|183004312|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|2.977||||0.003|||||||MCP-Mod exponential model fit|Model assumption: 35% of the maximum effect is achieved at medium dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.003
91557793|NCT04399837|183004312|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 12 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.468||||0.0269|TWO_SIDED|95.0|0.206|1.064||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: one-sided p-value ≤ 0.01875."|Log Rank||Hazard ratio and its 95% Confidence Interval are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||1.064|0.206|0.0269
91557794|NCT04399837|183004312|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 4 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.157||||0.0005|TWO_SIDED|95.0|0.046|0.541||"One-sided p-value is computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: One-sided p-value ≤0.0125."|Log Rank||Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||0.541|0.046|0.0005
91557795|NCT04399837|183004313|SUPERIORITY|Null hypothesis: The proportion of patients who do not experience a GPP flare up to week 48 on BI 655130 300 mg every 4 weeks ≤ Placebo.|Risk Difference (RD)|-0.39||||0.0013|TWO_SIDED|95.0|-0.621|-0.159||"One-sided p-value was computed from the Cochran-Mantel-Haenszel test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Cochran-Mantel-Haenszel||Risk difference=Spesolimab high dose-Placebo.|||-0.159|-0.621|0.0013
91768563|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
91768564|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
91768565|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||75.4|-75.4|1.000
91768566|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-86.7|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.0|-86.7|1.000
91557796|NCT04399837|183004314|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to first worsening of PSS up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.424||||0.0134|TWO_SIDED|95.0|0.197|0.914||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Log Rank||spesolimab high dose vs. Placebo|Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.||0.914|0.197|0.0134
91557797|NCT04399837|183004315|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to the first worsening of DLQI up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.259||||0.001|TWO_SIDED|95.0|0.109|0.62||One sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.|Log Rank||spesolimab high dose vs. Placebo|"Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"||0.620|0.109|0.0010
91557798|NCT02831816|183004319|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Median Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.221|0.18||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.180|-0.221|
91768567|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
91557799|NCT02831816|183004319|SUPERIORITY||Median Difference (Final Values)|2.45|||||TWO_SIDED|95.0|2.15|2.76||||||Groin 10 minutes Average Treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.76|2.15|
91557800|NCT02831816|183004320|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Mean Difference (Final Values)|-0.0435|||||TWO_SIDED|95.0|-0.2085|0.1215||||||Abdomen 10 minutes average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.1215|-0.2085|
91557801|NCT02831816|183004320|SUPERIORITY||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.7|2.25||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.25|1.70|
91557802|NCT02686658|183004321|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.|Least Squares Mean Difference|0.11||||0.0072|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0072
91557803|NCT02686658|183004321|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.|Least Squares Mean Difference|0.124||||0.0051|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0051
91557804|NCT02686658|183004322|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|1.39||||0.3464|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.3464
91768568|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|6.4||||1|TWO_SIDED|90.0|-31.2|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||44.0|-31.2|1.000
91768569|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-48.6|0.655
91768570|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|23.1||||0.541|TWO_SIDED|95.0|0.2|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.0|0.2|0.541
91768571|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-1.3||||1|TWO_SIDED|95.0|-37.0|34.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||34.4|-37.0|1.000
91557805|NCT02686658|183004322|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-0.28||||0.883|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8830
91557806|NCT02686658|183004323|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|0.38||||0.8405|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8405
91557807|NCT02686658|183004323|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-1.44||||0.5017|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.5017
91557808|NCT02609048|183004368|SUPERIORITY||Difference in LSM|-60.99|STANDARD_ERROR_OF_MEAN|5.814|<|0.0001|TWO_SIDED|95.0|-72.85|-49.13||Difference in mean,p-value, and CIs estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-49.13|-72.85|<0.0001
91557809|NCT02609048|183004368|SUPERIORITY||Difference in Least Squares Mean (LSM)|-51.37|STANDARD_ERROR_OF_MEAN|5.849|<|0.0001|TWO_SIDED|95.0|-63.3|-39.44||Difference in mean,p-value, and confidence intervals (CIs) estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-39.44|-63.30|<0.0001
91557810|NCT02609048|183004368|SUPERIORITY||Difference in Least Squares Mean (LSM)|-9.62|STANDARD_ERROR_OF_MEAN|5.963||0.1167|TWO_SIDED|95.0|-21.79|2.54||Difference in mean,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||2.54|-21.79|0.1167
91557811|NCT02609048|183004369|SUPERIORITY||||||<|0.0001||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||<0.0001
91557812|NCT02609048|183004369|SUPERIORITY|||||||0.0036||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||0.0036
91768572|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-29.1||||0.178|TWO_SIDED|95.0|-67.0|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||8.9|-67.0|0.178
91557813|NCT02609048|183004369|SUPERIORITY|||||||0.1045||||||The p-values were calculated from Fisher's exact test comparing Seladelpar 200mg versus 50 mg.|Fisher Exact|||||||0.1045
91557814|NCT02609048|183004370|SUPERIORITY||Difference in LSM|234.71|STANDARD_ERROR_OF_MEAN|104.647||0.0322|TWO_SIDED|95.0|21.28|448.14||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||448.14|21.28|0.0322
91557815|NCT02609048|183004370|SUPERIORITY||Difference in LSM|132.82|STANDARD_ERROR_OF_MEAN|96.015||0.1764|TWO_SIDED|95.0|-63.0|328.65||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||328.65|-63.00|0.1764
91557816|NCT02609048|183004370|SUPERIORITY||Difference in LSM|101.88|STANDARD_ERROR_OF_MEAN|103.504||0.3326|TWO_SIDED|95.0|-109.21|312.98||Difference between means, p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate, and percent change from baseline in AST as response variable.|ANCOVA|||||312.98|-109.21|0.3326
91557817|NCT02609048|183004371|SUPERIORITY||Difference in LSM|185.78|STANDARD_ERROR_OF_MEAN|104.379||0.0849|TWO_SIDED|95.0|-27.1|398.66||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline ALT assessment as covariate,and percent change from baseline in ALT as response variable.|ANCOVA|||||398.66|-27.10|0.0849
91557818|NCT02609048|183004371|SUPERIORITY||Difference in LSM|116.5|STANDARD_ERROR_OF_MEAN|97.437||0.2409|TWO_SIDED|95.0|-82.22|315.23||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||315.23|-82.22|0.2409
91557819|NCT02609048|183004371|SUPERIORITY||Difference in LSM|69.28|STANDARD_ERROR_OF_MEAN|105.295||0.5154|TWO_SIDED|95.0|-145.47|284.03||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||284.03|-145.47|0.5154
91768573|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|15.4||||1|TWO_SIDED|95.0|-4.2|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.0|-4.2|1.000
91557820|NCT02609048|183004372|SUPERIORITY||Difference in LSM|-45.34|STANDARD_ERROR_OF_MEAN|12.112||0.0007|TWO_SIDED|95.0|-70.04|-20.64||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-20.64|-70.04|0.0007
91557821|NCT02609048|183004372|SUPERIORITY||Difference in LSM|-40.78|STANDARD_ERROR_OF_MEAN|11.033||0.0008|TWO_SIDED|95.0|-63.28|-18.28||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-18.28|-63.28|0.0008
91557822|NCT02609048|183004372|SUPERIORITY||Difference in LSM|-4.56|STANDARD_ERROR_OF_MEAN|12.401||0.7155|TWO_SIDED|95.0|-29.85|20.73||Difference between means, p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||20.73|-29.85|0.7155
91557823|NCT02609048|183004373|SUPERIORITY||Difference in LSM|-34.27|STANDARD_ERROR_OF_MEAN|11.342||0.005|TWO_SIDED|95.0|-57.4|-11.14||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-11.14|-57.40|0.0050
91557824|NCT02609048|183004373|SUPERIORITY||Difference in LSM|-24.84|STANDARD_ERROR_OF_MEAN|10.116||0.0199|TWO_SIDED|95.0|-45.47|-4.21||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-4.21|-45.47|0.0199
91557825|NCT02609048|183004373|SUPERIORITY||Difference in LSM|-9.43|STANDARD_ERROR_OF_MEAN|11.442||0.4161|TWO_SIDED|95.0|-32.77|13.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||13.90|-32.77|0.4161
91557826|NCT02609048|183004374|SUPERIORITY||Difference in LSM|6.2|STANDARD_ERROR_OF_MEAN|8.626||0.478|TWO_SIDED|95.0|-11.4|23.79||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||23.79|-11.40|0.4780
91557827|NCT02609048|183004374|SUPERIORITY||Difference in LSM|-12.0|STANDARD_ERROR_OF_MEAN|8.043||0.1459|TWO_SIDED|95.0|-28.4|4.41||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||4.41|-28.40|0.1459
91557828|NCT02609048|183004374|SUPERIORITY||Difference in LSM|18.19|STANDARD_ERROR_OF_MEAN|8.521||0.0407|TWO_SIDED|95.0|0.82|35.57||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||35.57|0.82|0.0407
91768574|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-54.4|33.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||33.9|-54.4|1.000
91768575|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-48.6|0.655
91768576|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||46.3|-50.1|1.000
91768577|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-26.9||||0.32|TWO_SIDED|95.0|-73.0|19.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||19.2|-73.0|0.320
91768578|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||28.1|-48.6|0.655
91768579|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.3|-50.1|1.000
91768580|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-52.2|44.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.5|-52.2|1.000
91768581|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|1.7||||1|TWO_SIDED|95.0|-40.6|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.0|-40.6|1.000
91768582|NCT02365649|183425714|SUPERIORITY||Risk Difference (RD)|21.2||||0.603|TWO_SIDED|95.0|-29.2|71.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||71.5|-29.2|0.603
91768583|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|15.4||||0.673|TWO_SIDED|95.0|-25.6|56.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||56.5|-25.6|0.673
91768584|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|19.6||||0.265|TWO_SIDED|95.0|-14.0|53.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||53.3|-14.0|0.265
91768585|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|12.9||||0.695|TWO_SIDED|95.0|-25.6|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||51.5|-25.6|0.695
91768586|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-20.6||||0.394|TWO_SIDED|95.0|-61.4|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||20.3|-61.4|0.394
91768587|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-3.9||||1|TWO_SIDED|95.0|-36.1|28.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.3|-36.1|1.000
91768588|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-10.6||||0.683|TWO_SIDED|95.0|-47.9|26.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||26.7|-47.9|0.683
91768589|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|28.7||||0.205|TWO_SIDED|95.0|-4.1|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||61.4|-4.1|0.205
91557829|NCT02609048|183004375|SUPERIORITY||Difference in LSM|31.47|STANDARD_ERROR_OF_MEAN|13.831||0.03|TWO_SIDED|95.0|3.26|59.67||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||59.67|3.26|0.0300
91557830|NCT02609048|183004375|SUPERIORITY||Difference in LSM|-8.84|STANDARD_ERROR_OF_MEAN|12.883||0.4979|TWO_SIDED|95.0|-35.11|17.44||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||17.44|-35.11|0.4979
91557831|NCT02609048|183004375|SUPERIORITY||Difference in LSM|40.3|STANDARD_ERROR_OF_MEAN|13.591||0.0058|TWO_SIDED|95.0|12.58|68.02||Difference between means,p-value,and CIs are estimated for Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||68.02|12.58|0.0058
91557832|NCT02609048|183004376|SUPERIORITY||Difference in LSM|-2.97|STANDARD_ERROR_OF_MEAN|8.362||0.7244|TWO_SIDED|95.0|-20.03|14.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||14.08|-20.03|0.7244
91557833|NCT02609048|183004376|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|7.819||0.08|TWO_SIDED|95.0|-30.1|1.8||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||1.80|-30.10|0.0800
91557834|NCT02609048|183004376|SUPERIORITY||Difference in LSM|11.18|STANDARD_ERROR_OF_MEAN|8.29||0.1874|TWO_SIDED|95.0|-5.73|28.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||28.08|-5.73|0.1874
91557835|NCT02609048|183004377|SUPERIORITY||Difference in LSM|-45.96|STANDARD_ERROR_OF_MEAN|6.638|<|0.0001|TWO_SIDED|95.0|-59.5|-32.42||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-32.42|-59.50|<0.0001
91557836|NCT02609048|183004377|SUPERIORITY||Difference in LSM|-34.66|STANDARD_ERROR_OF_MEAN|6.46|<|0.0001|TWO_SIDED|95.0|-47.83|-21.48||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-21.48|-47.83|<0.0001
91768590|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|14.5||||0.388|TWO_SIDED|95.0|-17.9|46.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||46.9|-17.9|0.388
91768591|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-28.8||||0.236|TWO_SIDED|95.0|-65.6|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||8.0|-65.6|0.236
91557837|NCT02609048|183004377|SUPERIORITY||Difference in LSM|-11.3|STANDARD_ERROR_OF_MEAN|6.508||0.0924|TWO_SIDED|95.0|-24.58|1.97||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||1.97|-24.58|0.0924
91557838|NCT02609048|183004378|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|12.807||0.2777|TWO_SIDED|95.0|-40.27|11.97||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||11.97|-40.27|0.2777
91557839|NCT02609048|183004378|SUPERIORITY||Difference in LSM|-37.31|STANDARD_ERROR_OF_MEAN|11.946||0.0039|TWO_SIDED|95.0|-61.67|-12.95||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||-12.95|-61.67|0.0039
91557840|NCT02609048|183004378|SUPERIORITY||Difference in LSM|23.16|STANDARD_ERROR_OF_MEAN|12.498||0.0734|TWO_SIDED|95.0|-2.33|48.65||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||48.65|-2.33|0.0734
91557841|NCT02609048|183004379|SUPERIORITY||Difference in LSM|-16.12|STANDARD_ERROR_OF_MEAN|4.433||0.001|TWO_SIDED|95.0|-25.16|-7.07||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||-7.07|-25.16|0.0010
91768592|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-9.6||||1|TWO_SIDED|95.0|-50.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-50.6|1.000
91768593|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|26.3||||0.131|TWO_SIDED|95.0|-6.3|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.9|-6.3|0.131
91557842|NCT02609048|183004379|SUPERIORITY||Difference in LSM|-8.13|STANDARD_ERROR_OF_MEAN|3.992||0.0504|TWO_SIDED|95.0|-16.27|0.02||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.02|-16.27|0.0504
91557843|NCT02609048|183004379|SUPERIORITY||Difference in LSM|-7.99|STANDARD_ERROR_OF_MEAN|4.317||0.0738|TWO_SIDED|95.0|-16.8|0.81||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.81|-16.80|0.0738
91557844|NCT02609048|183004380|SUPERIORITY||Difference in LSM|-17.39|STANDARD_ERROR_OF_MEAN|5.848||0.0057|TWO_SIDED|95.0|-29.32|-5.46||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-5.46|-29.32|0.0057
91557845|NCT02609048|183004380|SUPERIORITY||Difference in LSM|-0.89|STANDARD_ERROR_OF_MEAN|5.378||0.8703|TWO_SIDED|95.0|-11.85|10.08||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||10.08|-11.85|0.8703
91557846|NCT02609048|183004380|SUPERIORITY||Difference in LSM|-16.51|STANDARD_ERROR_OF_MEAN|5.781||0.0076|TWO_SIDED|95.0|-28.3|-4.71||Difference between means,p-value,and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-4.71|-28.30|0.0076
91557847|NCT02609048|183004381|SUPERIORITY||Difference in LSM|-14.85|STANDARD_ERROR_OF_MEAN|5.981||0.0186|TWO_SIDED|95.0|-27.05|-2.66||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||-2.66|-27.05|0.0186
91557848|NCT02609048|183004381|SUPERIORITY||Difference in LSM|-10.06|STANDARD_ERROR_OF_MEAN|5.448||0.0745|TWO_SIDED|95.0|-21.17|1.06||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||1.06|-21.17|0.0745
91557849|NCT02609048|183004381|SUPERIORITY||Difference in LSM|-4.8|STANDARD_ERROR_OF_MEAN|5.785||0.4131|TWO_SIDED|95.0|-16.6|7.0||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||7.00|-16.60|0.4131
91557850|NCT02609048|183004382|SUPERIORITY|||||||0.4667||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.4667
91557851|NCT02609048|183004382|SUPERIORITY|||||||0.4667||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.4667
91557852|NCT02609048|183004383|SUPERIORITY|||||||0.0824||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0824
91557853|NCT02609048|183004383|SUPERIORITY|||||||0.0537||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0537
91557854|NCT02609048|183004383|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
91768594|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-7.1||||1|TWO_SIDED|95.0|-45.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-45.6|1.000
91557855|NCT02609048|183004384|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
91557856|NCT02609048|183004384|SUPERIORITY|||||||0.0198||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0198
91557857|NCT02609048|183004384|SUPERIORITY|||||||0.5165||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.5165
91557858|NCT02609048|183004385|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
91557859|NCT02609048|183004385|SUPERIORITY|||||||0.0055||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0055
91557860|NCT02609048|183004385|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
91557861|NCT02609048|183004387|SUPERIORITY||Difference in LSM|-1.1|STANDARD_ERROR_OF_MEAN|1.82||0.5379|TWO_SIDED|95.0|-4.8|2.6||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.6|-4.8|0.5379
91557862|NCT02609048|183004387|SUPERIORITY||Difference in LSM|0.2|STANDARD_ERROR_OF_MEAN|1.7||0.8949|TWO_SIDED|95.0|-3.3|3.7||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||3.7|-3.3|0.8949
91557863|NCT02609048|183004387|SUPERIORITY||Difference in LSM|-1.4|STANDARD_ERROR_OF_MEAN|1.75||0.4431|TWO_SIDED|95.0|-4.9|2.2||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.2|-4.9|0.4431
91768595|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|21.3||||0.411|TWO_SIDED|95.0|-19.6|62.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||62.2|-19.6|0.411
91557864|NCT02609048|183004388|SUPERIORITY||Difference in LSM|-7.4|STANDARD_ERROR_OF_MEAN|10.07||0.4674|TWO_SIDED|95.0|-28.0|13.2||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||13.2|-28.0|0.4674
91557865|NCT02609048|183004388|SUPERIORITY||Difference in LSM|-9.0|STANDARD_ERROR_OF_MEAN|8.99||0.3236|TWO_SIDED|95.0|-27.4|9.4||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||9.4|-27.4|0.3236
91557866|NCT02609048|183004388|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|9.92||0.8723|TWO_SIDED|95.0|-18.7|21.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||21.9|-18.7|0.8723
91557867|NCT02609048|183004389|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|1.25||0.0115|TWO_SIDED|95.0|0.8|6.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||6.0|0.8|0.0115
91557868|NCT02609048|183004389|SUPERIORITY||Difference in LSM|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1256|TWO_SIDED|95.0|-0.5|4.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.0|-0.5|0.1256
91557869|NCT02609048|183004389|SUPERIORITY||Difference in LSM|1.7|STANDARD_ERROR_OF_MEAN|1.22||0.1842|TWO_SIDED|95.0|-0.9|4.2||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.2|-0.9|0.1842
91557870|NCT02609048|183004389|SUPERIORITY||Difference in LSM|3.7|STANDARD_ERROR_OF_MEAN|1.7||0.042|TWO_SIDED|95.0|0.1|7.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||7.2|0.1|0.0420
91557871|NCT02609048|183004389|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|1.54||0.6384|TWO_SIDED|95.0|-2.4|3.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||3.9|-2.4|0.6384
91557872|NCT02609048|183004389|SUPERIORITY||Difference in LSM|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.1035|TWO_SIDED|95.0|-0.6|6.5||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||6.5|-0.6|0.1035
91557873|NCT02609048|183004389|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.96||0.6967|TWO_SIDED|95.0|-1.6|2.4||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.4|-1.6|0.6967
91557874|NCT02609048|183004389|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6164|TWO_SIDED|95.0|-1.3|2.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.2|-1.3|0.6164
91557875|NCT02609048|183004389|SUPERIORITY||Difference in LSM|-0.1|STANDARD_ERROR_OF_MEAN|0.93||0.9548|TWO_SIDED|95.0|-2.0|1.9|||ANCOVA|||Emotional Function Domain Score||1.9|-2.0|0.9548
91768596|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|32.2||||0.067|TWO_SIDED|95.0|-0.2|64.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.5|-0.2|0.067
91557876|NCT02609048|183004389|SUPERIORITY||Difference in LSM|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8286|TWO_SIDED|95.0|-2.4|1.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.9|-2.4|0.8286
91557877|NCT02609048|183004389|SUPERIORITY||Difference in LSM|4.2|STANDARD_ERROR_OF_MEAN|1.74||0.0226|TWO_SIDED|95.0|0.6|7.8||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||7.8|0.6|0.0226
91557878|NCT02609048|183004389|SUPERIORITY||Difference in LSM|-2.6|STANDARD_ERROR_OF_MEAN|1.92||0.1861|TWO_SIDED|95.0|-6.6|1.4||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||1.4|-6.6|0.1861
91557879|NCT02609048|183004389|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4159|TWO_SIDED|95.0|-2.4|5.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||5.7|-2.4|0.4159
91557880|NCT02609048|183004389|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|0.93||0.4848|TWO_SIDED|95.0|-1.3|2.6||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||2.6|-1.3|0.4848
91557881|NCT02609048|183004389|SUPERIORITY||Difference in LSM|-0.9|STANDARD_ERROR_OF_MEAN|1.05||0.4048|TWO_SIDED|95.0|-3.1|1.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.3|-3.1|0.4048
91557882|NCT02609048|183004389|SUPERIORITY||Difference in LSM|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0141|TWO_SIDED|95.0|0.6|4.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.7|0.6|0.0141
91557883|NCT02609048|183004389|SUPERIORITY||Difference in LSM|2.4|STANDARD_ERROR_OF_MEAN|0.9||0.0138|TWO_SIDED|95.0|0.5|4.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.2|0.5|0.0138
91557884|NCT02609048|183004389|SUPERIORITY||Difference in LSM|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7911|TWO_SIDED|95.0|-1.8|2.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||2.3|-1.8|0.7911
91557885|NCT01276509|183004393|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.05|STANDARD_ERROR_OF_MEAN|0.121||0.3393|TWO_SIDED|90.0|-0.149|0.249|||Mixed Models Analysis|||Difference from placebo at Week 8||0.249|-0.149|0.3393
91557886|NCT01276509|183004393|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.117||0.1433|TWO_SIDED|90.0|-0.068|0.316|||Mixed Models Analysis|||Difference from placebo at Week 8||0.316|-0.068|0.1433
91557887|NCT01276509|183004393|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.15|STANDARD_ERROR_OF_MEAN|0.113||0.0922|TWO_SIDED|90.0|-0.036|0.335|||Mixed Models Analysis|||Difference from placebo at Week 8||0.335|-0.036|0.0922
91557888|NCT01276509|183004393|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.034|STANDARD_ERROR_OF_MEAN|0.117||0.3864|TWO_SIDED|90.0|-0.158|0.225|||Mixed Models Analysis|||Difference from placebo at Week 12||0.225|-0.158|0.3864
91768597|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-1.2||||1|TWO_SIDED|95.0|-39.5|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||37.2|-39.5|1.000
91768598|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|26.6||||0.178|TWO_SIDED|95.0|-8.8|62.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||62.0|-8.8|0.178
91557889|NCT01276509|183004393|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.061|STANDARD_ERROR_OF_MEAN|0.117||0.3005|TWO_SIDED|90.0|-0.131|0.253|||Mixed Models Analysis|||Difference from placebo at Week 12||0.253|-0.131|0.3005
91557890|NCT01276509|183004393|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.011|STANDARD_ERROR_OF_MEAN|0.114||0.5385|TWO_SIDED|90.0|-0.198|0.176|||Mixed Models Analysis|||Difference from placebo at Week 12||0.176|-0.198|0.5385
91557891|NCT01276509|183004396|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.107||0.1234|TWO_SIDED|90.0|-0.052|0.299|||Mixed Models Analysis|||Difference from placebo at week 8||0.299|-0.052|0.1234
91557892|NCT01276509|183004396|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.071|STANDARD_ERROR_OF_MEAN|0.099||0.2378|TWO_SIDED|90.0|-0.092|0.234|||Mixed Models Analysis|||Difference from placebo at week 8||0.234|-0.092|0.2378
91557893|NCT01276509|183004396|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.102|STANDARD_ERROR_OF_MEAN|0.1||0.1529|TWO_SIDED|90.0|-0.062|0.266|||Mixed Models Analysis|||Difference from placebo at week 8||0.266|-0.062|0.1529
91557894|NCT01276509|183004396|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.038|STANDARD_ERROR_OF_MEAN|0.112||0.3661|TWO_SIDED|90.0|-0.146|0.222|||Mixed Models Analysis|||Difference from placebo at week 12||0.222|-0.146|0.3661
91557895|NCT01276509|183004396|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.055|STANDARD_ERROR_OF_MEAN|0.116||0.3169|TWO_SIDED|90.0|-0.136|0.246|||Mixed Models Analysis|||Difference from placebo at week 12||0.246|-0.136|0.3169
91557896|NCT01276509|183004396|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.2755|TWO_SIDED|90.0|-0.116|0.248|||Mixed Models Analysis|||Difference from placebo at week 12||0.248|-0.116|0.2755
91768599|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.7||||0.72|TWO_SIDED|95.0|-23.8|12.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.3|-23.8|0.720
91557897|NCT03964974|183004412|SUPERIORITY|2-sided hypothesis tests were utilized to compare ISI score over time in the two treatment conditions.|Median Difference (Final Values)|-4.307|STANDARD_ERROR_OF_MEAN|1.612||0.0041|TWO_SIDED|95.0|-7.51|-1.104||This is the calculated p-value. The threshold for statistical significance was 0.05.|Mixed Models Analysis|||Persons in the CBTI-CB condition were hypothesized as realizing greater reduction in insomnia severity as measured by the Insomnia Severity Index (ISI) over time compared to the Sleep Hygiene Education (SHE) condition. 80% power was estimated to detect a medium or larger effect size (d\>0.52) on sleep- and functioning-related outcomes, even with a more conservative alpha set at 0.017 (i.e., 0.05/3 for the 3 outcomes).|Parameter is estimated difference in final means, CBTi-CB - Control. Minus sign denotes greater decrease for CBTi-CB. Effect size for Time X Condition = 0.81|-1.104|-7.510|0.0041
91557898|NCT03926026|183004460|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0471|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||||0|-1.5|0.0471
91557899|NCT00413283|183004464|SUPERIORITY_OR_OTHER|||||||0.972|||||||Satterthwaite t-test|||||||0.972
91557900|NCT00413283|183004464|SUPERIORITY_OR_OTHER|||||||0.725|||||||Satterthwaite t-test|||||||0.725
91557901|NCT00413283|183004464|SUPERIORITY_OR_OTHER|||||||0.312|||||||Satterthwaite t-test|||||||0.312
91557902|NCT00413283|183004465|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91557903|NCT00413283|183004465|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91557904|NCT00413283|183004465|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91557905|NCT00413283|183004466|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91557906|NCT00413283|183004466|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91557907|NCT00413283|183004466|SUPERIORITY_OR_OTHER|||||||0.342|||||||Fisher Exact|||||||0.342
91557908|NCT00413283|183004467|SUPERIORITY_OR_OTHER|||||||0.454|||||||Satterthwaite t-test|||||||0.454
91557909|NCT00413283|183004467|SUPERIORITY_OR_OTHER|||||||0.101|||||||Satterthwaite t-test|||||||0.101
91557910|NCT00413283|183004467|SUPERIORITY_OR_OTHER|||||||0.199|||||||Satterthwaite t-test|||||||0.199
91557911|NCT00413283|183004468|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
91557912|NCT00413283|183004468|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
91557913|NCT00413283|183004468|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
91557914|NCT02660086|183004472|SUPERIORITY||Mean Difference (Net)|0.2||||0.7|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||||1.0|-0.6|0.70
91557915|NCT02660086|183004473|SUPERIORITY||Mean Difference (Net)|0.6||||0.2|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||||1.4|-0.3|0.20
91557916|NCT02660086|183004474|SUPERIORITY||Mean Difference (Net)|-1.3||||0.24|TWO_SIDED|95.0|-3.6|0.9|||Mixed Models Analysis|||Change in systolic BP at 12 months||0.9|-3.6|0.24
91557917|NCT02660086|183004474|SUPERIORITY||Mean Difference (Net)|1.5||||0.19|TWO_SIDED|95.0|-0.7|3.7|||Mixed Models Analysis|||Change in systolic BP at 24 months||3.7|-0.7|0.19
91557918|NCT02660086|183004474|SUPERIORITY||Mean Difference (Net)|-1.6||||0.07|TWO_SIDED|95.0|-3.2|0.1|||Mixed Models Analysis|||Change in diastolic BP at 12 months||0.1|-3.2|0.07
91557919|NCT02660086|183004474|SUPERIORITY||Mean Difference (Net)|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.6|||Mixed Models Analysis|||Change in diastolic BP at 24 months||1.6|-1.5|0.94
91557920|NCT02660086|183004475|SUPERIORITY||Mean Difference (Net)|-1.3||||0.54|TWO_SIDED|95.0|-5.6|2.9|||Mixed Models Analysis|||Change in total cholesterol at 12 months||2.9|-5.6|0.54
91557921|NCT02660086|183004475|SUPERIORITY||Mean Difference (Net)|1.6||||0.53|TWO_SIDED|95.0|-3.5|6.7|||Mixed Models Analysis|||Change in total cholesterol at 24 months||6.7|-3.5|0.53
91557922|NCT02660086|183004476|SUPERIORITY||Mean Difference (Net)|-1.2||||0.51|TWO_SIDED|95.0|-4.8|2.4|||Mixed Models Analysis|||Change in LDL at 12 months||2.4|-4.8|0.51
91557923|NCT02660086|183004476|SUPERIORITY||Mean Difference (Net)|1.2||||0.6|TWO_SIDED|95.0|-3.4|5.7|||Mixed Models Analysis|||Change in LDL at 24 months||5.7|-3.4|0.60
91557924|NCT02660086|183004477|SUPERIORITY||Mean Difference (Net)|-2.9||||0.48|TWO_SIDED|95.0|-10.8|5.1|||Mixed Models Analysis|||Change in triglycerides at 12 months||5.1|-10.8|0.48
91557925|NCT02660086|183004477|SUPERIORITY||Mean Difference (Net)|4.0||||0.29|TWO_SIDED|95.0|-3.4|11.5|||Mixed Models Analysis|||Change in triglycerides at 24 months||11.5|-3.4|0.29
91557926|NCT02660086|183004478|SUPERIORITY||Mean Difference (Net)|-0.2||||0.8|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Change in HDL at 12 months||1.5|-1.9|0.80
91557927|NCT02660086|183004478|SUPERIORITY||Mean Difference (Net)|-0.3||||0.72|TWO_SIDED|95.0|-1.9|1.3|||Mixed Models Analysis|||Change in HDL at 24 months||1.3|-1.9|0.72
91557928|NCT02660086|183004479|SUPERIORITY||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 12 months||0.1|-0.1|0.62
91557929|NCT02660086|183004479|SUPERIORITY||Mean Difference (Net)|0.0||||0.4|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 24 months||0.1|0.0|0.40
91557930|NCT02660086|183004480|SUPERIORITY||Mean Difference (Net)|7.3|||<|0.001|TWO_SIDED|95.0|5.4|9.3|||Mixed Models Analysis|||Change in green labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||9.3|5.4|<0.001
91557931|NCT02660086|183004480|SUPERIORITY||Mean Difference (Net)|4.8|||<|0.001|TWO_SIDED|95.0|2.9|6.8|||Mixed Models Analysis|||Change in green-labeled purhases during 12 month follow-up (months 13-24) compared to 12 month baseline||6.8|2.9|<0.001
91557932|NCT02660086|183004481|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.7|||Mixed Models Analysis|||Change in red labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||-2.7|-5.0|<0.001
91557933|NCT02660086|183004481|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|||Change in red labeled purchases during 12-month follow up (months 13-24) compared to baseline 12 months||-2.0|-4.3|<0.001
91557934|NCT02660086|183004482|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|4.2|7.0|||Mixed Models Analysis|||Change in healthy purchasing score during 12 month intervention (months 1-12) compared to baseline 12 months||7.0|4.2|<0.001
91557935|NCT02660086|183004482|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.001|TWO_SIDED|95.0|2.6|5.3|||Mixed Models Analysis|||Change in Healthy Purchasing Score during 12 month follow up (months 13-24) compared to baseline 12 months||5.3|2.6|<0.001
91557936|NCT02660086|183004483|SUPERIORITY||Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-0.6|4.1||||||Change in HEI scores at 12 months.||4.1|-0.6|
91557937|NCT02660086|183004483|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-0.7|3.8||||||Change in HEI scores at 24 months||3.8|-0.7|
91557938|NCT01377844|183004484|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||||-0.53|-1.06|< 0.0001
91557939|NCT01377844|183004485|SUPERIORITY||Difference of LS Means|-5.53|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline systolic BP, baseline HbA1c category, site, age category, gender and race||||-3.04|-8.02|< 0.0001
91557940|NCT01377844|183004485|SUPERIORITY||Difference of LS Means|-2.67||||0.0015|TWO_SIDED|95.0|-4.3|-1.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race||||-1.04|-4.30|0.0015
91557941|NCT01377844|183004486|SUPERIORITY||Difference of LS Means|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.52|-0.93||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline weight, baseline HbA1c category, site, age category, gender and race||||-0.93|-2.52|< 0.0001
91557942|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.42|-0.21||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 2||-0.21|-0.42|< 0.0001
91557943|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.41||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 6||-0.41|-0.78|< 0.0001
91557944|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.48||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 12||-0.48|-0.96|< 0.0001
91557945|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.44||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 18||-0.44|-0.97|< 0.0001
91557946|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 24||-0.53|-1.06|< 0.0001
91557947|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.66||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 36||-0.66|-1.21|< 0.0001
91557948|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.7||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 48||-0.70|-1.28|< 0.0001
91557949|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.68||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 60||-0.68|-1.27|< 0.0001
91557950|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.64||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 72||-0.64|-1.22|< 0.0001
91557951|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.69||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 84||-0.69|-1.27|< 0.0001
91557952|NCT01377844|183004487|SUPERIORITY||Difference of LS Means|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.73||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 96||-0.73|-1.31|< 0.0001
91557953|NCT01377844|183004488|SUPERIORITY||Difference of LS Means|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.79|-1.7||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 2, between EGT0001442 and Placebo group.||-1.70|-2.79|< 0.0001
91557954|NCT01377844|183004488|SUPERIORITY||Difference of LS Means|-2.45|||<|0.0001|TWO_SIDED|95.0|-3.09|-1.81||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group.||-1.81|-3.09|< 0.0001
91557955|NCT01377844|183004488|SUPERIORITY||Difference of LS Means|-2.42|||<|0.0001|TWO_SIDED|95.0|-3.06|-1.77||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group.||-1.77|-3.06|< 0.0001
91557956|NCT01377844|183004488|SUPERIORITY||Difference of LS Means|-2.71|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.11||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group.||-2.11|-3.30|< 0.0001
91557957|NCT01377844|183004488|SUPERIORITY||Difference of LS Means|-2.63|||<|0.0001|TWO_SIDED|95.0|-3.24|-2.02||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group.||-2.02|-3.24|< 0.0001
91557958|NCT01653509|183004490|SUPERIORITY_OR_OTHER||Least square mean difference|-911.48||||0.3061|TWO_SIDED|95.0|-2712.65|889.69|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||889.69|-2712.65|0.3061
91557959|NCT01653509|183004490|SUPERIORITY_OR_OTHER||LS Mean Difference|-150.99||||0.4035|TWO_SIDED|95.0|-517.97|215.99|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between treatments for MEV.||215.99|-517.97|0.4035
91557960|NCT01653509|183004491|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48||||0.0486|TWO_SIDED|95.0|0.02|4.93|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).||4.93|0.02|0.0486
91557961|NCT01653509|183004491|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.0799|TWO_SIDED|95.0|-0.05|0.82|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||0.82|-0.05|0.0799
91557962|NCT01653509|183004492|SUPERIORITY_OR_OTHER||LS mean difference|2.14||||0.179|TWO_SIDED|95.0|-1.06|5.35|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||5.35|-1.06|0.1790
91557963|NCT01653509|183004492|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.2446|TWO_SIDED|95.0|-0.27|1.0|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||1.00|-0.27|0.2446
91557964|NCT01214200|183004499|OTHER|For the analysis of differences between pre and post treatment a student's t-test was used and was checked with the Wilcoxon signed rank test. A p\<0.05 was considered statistically significant.||||||0.01|||||||Wilcoxon Signed Ranks Test|||||||0.01
91557965|NCT01823224|183004508|SUPERIORITY_OR_OTHER|||||||0.875|TWO_SIDED||||||Repeated analysis of variance|||||||0.875
91557966|NCT01823224|183004509|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Manova|||||||> 0.05
91557967|NCT01303796|183004526|SUPERIORITY||Hazard Ratio (HR)|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Kaplan-Meier|||The phase III part planned to randomize 485 patients, about 243 per arm (actual 241 patients per arm), over an estimated period of 24 months. Final analysis would occur at approximately 424 deaths, which was expected to be observed about 43 months after the accrual of the first patient. A stratified log rank analysis would have 90% power to detect a 27.5% reduction in the risk of death, i.e., a hazard ratio of 0.725, between Arm A and Arm C.||1.226|0.837|<0.0249
91557968|NCT01303796|183004526|SUPERIORITY||Cox Proportional Hazard|1.08|||<|0.0249|TWO_SIDED|95.0|0.86|1.35||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Presence of antecedent MDS or MPD (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: No (i.e., de novo) vs Presence of antecedent MDS or MPD"||1.35|0.86|<0.0249
91557969|NCT01303796|183004526|SUPERIORITY|Effects of treatments compared in AML patients with baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L|Cox Proportional Hazard|1.57|||<|0.0249|TWO_SIDED|95.0|1.12|2.19||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline peripheral WBC count ≥ 10 x 109/L (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L"||2.19|1.12|<0.0249
91557970|NCT01303796|183004526|SUPERIORITY||Cox Proportional Hazard|1.01|||<|0.0249|TWO_SIDED|95.0|0.77|1.32||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline bone marrow blast percentage ≥ 50% (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline bone marrow blast percentage ≥ 50% vs Blast percentage ≤ 50%"||1.32|0.77|<0.0249
91557971|NCT01303796|183004526|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.0249|TWO_SIDED|95.0|0.94|1.73|||Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Unfavorable cytogenetics risk by SWOG (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Unfavorable cytogenetics vs other"||1.73|0.94|<0.0249
91557972|NCT01303796|183004526|SUPERIORITY||Cox Proportional Hazard|1.222|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Region (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: EU vs US"||||<0.0249
91557973|NCT01303796|183004526|SUPERIORITY||Cox Proportional Hazard|1.071|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Age (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: ≥ 75 years old vs ≤ 75 years old"||||<0.0249
91557974|NCT01303796|183004526|SUPERIORITY||Cox Proportional Hazard|0.956|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Gender (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Male vs Female"||||<0.0249
91557975|NCT01303796|183004526|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): ECOG status (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Status 2 vs \< 2"||||<0.0249
91557976|NCT01303796|183004526|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): HCT-CI score (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: HCT-CI score 0-2 vs HCT-CI score \>2"||||<0.0249
91557977|NCT01303796|183004527|SUPERIORITY||Cox Proportional Hazard|1.34||||0.1468|TWO_SIDED|95.0|0.645|2.782|||Fisher Exact|||||2.782|0.645|0.1468
91557978|NCT01303796|183004532|SUPERIORITY|||||||0.0416|||||||Wilcoxon (Mann-Whitney)|||||||0.0416
91557979|NCT01303796|183004533|SUPERIORITY|||||||0.1568|||||||Wilcoxon (Mann-Whitney)|||||||0.1568
91557980|NCT01303796|183004534|SUPERIORITY||Cox Proportional Hazard|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Log Rank|||||1.226|0.837|<0.0249
91557981|NCT02148705|183004547|SUPERIORITY||Odds Ratio (OR)|288.281|||<|0.0001|TWO_SIDED|95.0|35.549|13984.356|||Fisher Exact|||||13984.356|35.549|<0.0001
91557982|NCT02148705|183004548|SUPERIORITY||Odds Ratio (OR)|0.011|||<|0.0001|TWO_SIDED|95.0|0.003|0.044|||Chi-squared|||||0.044|0.003|<0.0001
91557983|NCT02148705|183004549|SUPERIORITY||Test Statistics|23.1429|||<|0.0001|TWO_SIDED||||||Generalized Wilcoxon-Gehan Test|Analysis is adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs||||||<0.0001
91557984|NCT02148705|183004550|SUPERIORITY||estimate|6505.8|STANDARD_ERROR_OF_MEAN|269.88|<|0.0001|TWO_SIDED|95.0|5974.41|7037.19|||Wilcoxon (Mann-Whitney)|Wilcoxon tests pooled using Rubin´s rule||||7037.19|5974.41|<0.0001
91557985|NCT02310581|183004556|OTHER||LS Mean Difference|104.973|STANDARD_ERROR_OF_MEAN|39.2433||0.012|TWO_SIDED|95.0|25.13|184.81|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||184.81|25.13|0.012
91557986|NCT02310581|183004556|OTHER||LS Mean Difference|86.316|STANDARD_ERROR_OF_MEAN|37.5385||0.028|TWO_SIDED|95.0|9.94|162.69|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||162.69|9.94|0.028
91557987|NCT02310581|183004556|OTHER||LS Mean Difference|64.485|STANDARD_ERROR_OF_MEAN|39.2459||0.11|TWO_SIDED|95.0|-15.36|144.33|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||144.33|-15.36|0.110
91557988|NCT02310581|183004559|OTHER||LS Mean Difference|14.398|STANDARD_ERROR_OF_MEAN|4.739||0.005|TWO_SIDED|95.0|4.76|24.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||24.04|4.76|0.005
91557989|NCT02310581|183004559|OTHER||LS Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|4.5331||0.085|TWO_SIDED|95.0|-1.17|17.28|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||17.28|-1.17|0.085
91557990|NCT02310581|183004559|OTHER||LS Mean Difference|10.063|STANDARD_ERROR_OF_MEAN|4.7393||0.041|TWO_SIDED|95.0|0.42|19.7|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||19.70|0.42|0.041
91557991|NCT02310581|183004560|OTHER||LS Mean Difference|26.665|STANDARD_ERROR_OF_MEAN|8.1991||3|TWO_SIDED|95.0|9.98|43.35|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||43.35|9.98|0003
91557992|NCT02310581|183004560|OTHER||LS Mean Difference|21.605|STANDARD_ERROR_OF_MEAN|7.8429||0.009|TWO_SIDED|95.0|5.65|37.56|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||37.56|5.65|0.009
91557993|NCT02310581|183004560|OTHER||LS Mean Difference|22.143|STANDARD_ERROR_OF_MEAN|8.1997||0.011|TWO_SIDED|95.0|5.46|38.83|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||38.83|5.46|0.011
91557994|NCT02310581|183004561|OTHER||LS Mean Difference|63.881|STANDARD_ERROR_OF_MEAN|18.3971||0.001|TWO_SIDED|95.0|26.45|101.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||101.31|26.45|0.001
91557995|NCT02310581|183004561|OTHER||LS Mean Difference|50.284|STANDARD_ERROR_OF_MEAN|17.5979||0.007|TWO_SIDED|95.0|14.48|86.09|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||86.09|14.48|0.007
91557996|NCT02310581|183004561|OTHER||LS Mean Difference|56.879|STANDARD_ERROR_OF_MEAN|18.3984||0.004|TWO_SIDED|95.0|19.45|94.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||94.31|19.45|0.004
91557997|NCT02824198|183004565|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.34|||||TWO_SIDED|95.0|0.998|1.79||||||Dengue Virus Serotype 1||1.79|0.998|
91557998|NCT02824198|183004565|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.603|||||TWO_SIDED|95.0|0.439|0.829||||||Dengue Virus Serotype 2||0.829|0.439|
91557999|NCT02824198|183004565|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.979|||||TWO_SIDED|95.0|0.746|1.28||||||Dengue Virus Serotype 3||1.28|0.746|
91558000|NCT02824198|183004565|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|1.27|||||TWO_SIDED|95.0|0.918|1.75||||||Dengue Virus Serotype 4||1.75|0.918|
91558001|NCT00887224|183004578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.|Log Rank|||||||<0.001
91558002|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9627|TWO_SIDED|95.0|-0.09|0.08||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.08|-0.09|0.9627
91558003|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.1046|TWO_SIDED|95.0|-0.02|0.21||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.21|-0.02|0.1046
91558004|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.0228|TWO_SIDED|95.0|0.02|0.25||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.25|0.02|0.0228
91558005|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.0064|TWO_SIDED|95.0|0.05|0.29||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||0.29|0.05|0.0064
91558006|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||0.39|0.11|<0.001
91558007|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.43||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||0.43|0.12|<0.001
91558008|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||0.47|0.19|<0.001
91558009|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.17|0.49||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||0.49|0.17|<0.001
91558010|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||<|0.001|TWO_SIDED|95.0|0.25|0.62||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||0.62|0.25|<0.001
91558011|NCT00887224|183004580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||0.61|0.28|<0.001
91558012|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8853|TWO_SIDED|95.0|-0.41|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.47|-0.41|0.8853
91558013|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0081|TWO_SIDED|95.0|0.23|1.52||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||1.52|0.23|0.0081
91558014|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0038|TWO_SIDED|95.0|0.28|1.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||1.47|0.28|0.0038
91558015|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.76|2.03||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||2.03|0.76|<0.001
91558016|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|0.86|2.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||2.39|0.86|<0.001
91558017|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.83|2.54||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||2.54|0.83|<0.001
91558018|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.001|TWO_SIDED|95.0|1.23|2.86||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||2.86|1.23|<0.001
91558019|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|||<|0.001|TWO_SIDED|95.0|1.06|2.84||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||2.84|1.06|<0.001
91558020|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.31|3.3||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||3.30|1.31|<0.001
91558021|NCT00887224|183004581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.39|3.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||3.32|1.39|<0.001
91558022|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9142|TWO_SIDED|95.0|-0.24|0.27||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.27|-0.24|0.9142
91558023|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.0069|TWO_SIDED|95.0|0.15|0.91||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.91|0.15|0.0069
91558024|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0023|TWO_SIDED|95.0|0.21|0.95||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.95|0.21|0.0023
91558025|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|||<|0.001|TWO_SIDED|95.0|0.49|1.28||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||1.28|0.49|<0.001
91558026|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.43|1.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||1.32|0.43|<0.001
91558027|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.58|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||1.58|0.58|<0.001
91558028|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||1.58|0.66|<0.001
91558029|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.76|1.83||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||1.83|0.76|<0.001
91558030|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.001|TWO_SIDED|95.0|0.7|1.76||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||1.76|0.70|<0.001
91558031|NCT00887224|183004582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.75|1.79||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||1.79|0.75|<0.001
91558032|NCT00887224|183004583|SUPERIORITY_OR_OTHER||Adjusted odds ratio|2.85|||<|0.0001|TWO_SIDED|95.0|1.93|4.2||Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.|Regression, Logistic|||Wald 95% CI for adjusted odds ratio.||4.20|1.93|<0.0001
91558033|NCT00887224|183004584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.001|TWO_SIDED|95.0|-3.03|-1.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||-1.24|-3.03|<0.001
91558034|NCT00887224|183004584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|||<|0.001|TWO_SIDED|95.0|-3.29|-1.34||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||-1.34|-3.29|<0.001
91558035|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6772|TWO_SIDED|95.0|-3.82|5.87||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Absenteeism||5.87|-3.82|0.6772
91558036|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.9059|TWO_SIDED|95.0|-5.91|5.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Absenteeism||5.24|-5.91|0.9059
91558037|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.91||||0.0414|TWO_SIDED|95.0|0.27|13.55||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Presenteeism||13.55|0.27|0.0414
91558038|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.24||||0.0129|TWO_SIDED|95.0|1.77|14.71||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Presenteeism||14.71|1.77|0.0129
91558039|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48||||0.0402|TWO_SIDED|95.0|0.34|14.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Work Productivity Loss||14.61|0.34|0.0402
91558040|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48||||0.0187|TWO_SIDED|95.0|1.43|15.53||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Work Productivity Loss||15.53|1.43|0.0187
91558041|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.57|||<|0.001|TWO_SIDED|95.0|3.33|11.8||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Activity Impairment||11.80|3.33|<0.001
91558042|NCT00887224|183004585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.62|||<|0.001|TWO_SIDED|95.0|3.14|12.1||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Activity Impairment||12.10|3.14|<0.001
91558043|NCT03883828|183004586|SUPERIORITY||Multivariable Linear Regression|-0.45||||0.004|TWO_SIDED|95.0|-0.75|-0.15||Two-sided p-values equal to or less than 0.05 were considered statistically significant|Fisher Exact|||||-0.15|-0.75|0.004
91558044|NCT03883828|183004587|SUPERIORITY|||||||0.2||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Symptoms Domain||||||0.20
91558045|NCT03883828|183004587|SUPERIORITY|||||||0.05||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Emotions Domain||||||0.05
91558046|NCT03883828|183004587|SUPERIORITY|||||||0.73||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Functioning Domain||||||0.73
91558047|NCT00403494|183004593|SUPERIORITY|PWT was transformed to the log ratio at Week 24:Baseline for statistical analysis.|Mean Difference (Final Values)|-0.021|STANDARD_DEVIATION|0.379||0.727|TWO_SIDED|95.0|-0.138|0.097|||t-test, 2 sided||Mean difference represents the difference of the means of the natural log-transformed ratios between the 2 treatment groups.|||0.097|-0.138|0.727
91558048|NCT00487240|183004632|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority limit of 0.4% using the upper limit of a two-sided test at a significance level of 0.05 with 90% power assuming a 1.1 Standard Deviations (SD)|Mean Difference (Net)|-0.1||||0.332||95.0|-0.29|0.1|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.||0.10|-0.29|0.332
91558049|NCT00487240|183004633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.718||95.0|-0.22|0.15||P-value for 8 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference=Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.22|0.718
91558050|NCT00487240|183004633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.187||95.0|-0.34|0.07||P-value for 16 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.07|-0.34|0.187
91558051|NCT00487240|183004633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.704||95.0|-0.25|0.17||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.17|-0.25|0.704
91768600|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-7.9||||0.683|TWO_SIDED|95.0|-27.2|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.5|-27.2|0.683
91768601|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|23.0||||0.215|TWO_SIDED|95.0|-12.8|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||58.9|-12.8|0.215
91558052|NCT00487240|183004633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.599||95.0|-0.27|0.15||P-value for 32 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.27|0.599
91558053|NCT00487240|183004634|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c ≤7.0%.|Fisher Exact|||||||1.000
91558054|NCT00487240|183004634|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c \<7.0%|Fisher Exact|||||||1.000
91558055|NCT00487240|183004634|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value for With HbA1c ≤6.5%|Fisher Exact|||||||0.722
91558056|NCT00487240|183004634|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value for With HbA1c \<6.5%|Fisher Exact|||||||0.699
91558057|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-value for Daily Mean 7-Point SMBG.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.259
91558058|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for Daily Mean Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.468
91558059|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||P-value for Daily Mean Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.395
91558060|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value for Daily Mean Morning and Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.414
91558061|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Actual Morning Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.275
91558062|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||P-value for Actual Morning Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.611
91558063|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.763||95.0||||P-value for Actual Midday Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.763
91558064|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||P-value for Actual Midday Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.977
91558065|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.586||95.0||||P-value for Actual Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.586
91558066|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Actual Evening Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.093
91558067|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value for Actual 0300 Hours|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.516
91558068|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value for Actual Morning SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.576
91558069|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||P-value for Midday SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.876
91558070|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for Evening SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.261
91558071|NCT00487240|183004635|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value for Daily Mean SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.567
91558072|NCT00487240|183004636|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.8 mmol/L was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.36||||||95.0|-0.03|0.75|||||Least Squares Mean difference = Insulin Lispro Protamine Suspension - Detemir|If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis \[primary outcome measure\] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.||0.75|-0.03|
91558073|NCT00487240|183004636|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for M-Value|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.132
91558074|NCT00487240|183004636|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value for MODD|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.179
91558075|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Endpoint Hypoglycemic Episodes|Fisher Exact|||||||0.737
91558076|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||P-value for Overall Hypoglycemic Episodes|Fisher Exact|||||||0.724
91558077|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.157
91558078|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-value for Overall Nocturnal Episodes|Fisher Exact|||||||0.287
91558079|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.664
91558080|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.730
91558081|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Endpoint Severe Hypoglycemic Episodes|Fisher Exact|||||||0.053
91558082|NCT00487240|183004637|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value for Overall Severe Hypoglycemic Episodes|Fisher Exact|||||||0.081
91558083|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Endpoint Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.280
91558084|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||P-value for Overall Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.193
91558085|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.042
91558086|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.001
91558087|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.579
91558088|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.531
91558089|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Endpoint Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.017
91558090|NCT00487240|183004638|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Overall Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.038
91558091|NCT00487240|183004640|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 1.5 kg was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.97||||0.003||95.0|0.34|1.6||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.||1.60|0.34|0.003
91558092|NCT00487240|183004641|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.023
91558093|NCT00487240|183004641|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.004
91558094|NCT00487240|183004641|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.282
91558095|NCT00487240|183004642|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.82
91558096|NCT00487240|183004642|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.19
91558097|NCT00487240|183004642|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.416
91558098|NCT02736188|183004644|SUPERIORITY||LS Mean Difference|0.8||||0.4287|TWO_SIDED|95.0|-1.17|2.77||Baseline is fit into the model as a covariate.|generalized estimating equation (GEE)|||Week 8||2.77|-1.17|0.4287
91558099|NCT02736188|183004644|SUPERIORITY||LS Mean Difference|0.36||||0.7031|TWO_SIDED|95.0|-1.49|2.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.21|-1.49|0.7031
91558100|NCT02736188|183004644|SUPERIORITY||LS Mean Difference|-0.91||||0.4253|TWO_SIDED|95.0|-3.14|1.32||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.32|-3.14|0.4253
91558101|NCT02736188|183004644|SUPERIORITY||LS Mean Difference|-0.06||||0.9747|TWO_SIDED|95.0|-3.49|3.38||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.38|-3.49|0.9747
91558102|NCT02736188|183004645|SUPERIORITY||LS Mean Difference|-0.27||||0.4721|TWO_SIDED|95.0|-1.01|0.47||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.47|-1.01|0.4721
91558103|NCT02736188|183004645|SUPERIORITY||LS Mean Difference|-0.19||||0.6611|TWO_SIDED|95.0|-1.02|0.64||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.64|-1.02|0.6611
91558104|NCT02736188|183004645|SUPERIORITY||LS Mean Difference|-0.44||||0.276|TWO_SIDED|95.0|-1.22|0.35|||GEE model|Baseline is fit into the model as a covariate.||Week 24||0.35|-1.22|0.2760
91558105|NCT02736188|183004645|SUPERIORITY||LS Mean Difference|-0.28||||0.6977|TWO_SIDED|95.0|-1.69|1.13||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.13|-1.69|0.6977
91558106|NCT02736188|183004646|SUPERIORITY||Difference in LS Means|0.7||||0.0648|TWO_SIDED|95.0|-0.04|1.45||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.45|-0.04|0.0648
91558107|NCT02736188|183004646|SUPERIORITY||difference in LS means|0.74||||0.0692|TWO_SIDED|95.0|-0.06|1.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.55|-0.06|0.0692
91558108|NCT02736188|183004646|SUPERIORITY||difference in LS means|0.44||||0.4317|TWO_SIDED|95.0|-0.65|1.52||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.52|-0.65|0.4317
91558109|NCT02736188|183004646|SUPERIORITY||difference in LS means|-0.34||||0.6416|TWO_SIDED|95.0|-1.78|1.1||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.10|-1.78|0.6416
91558110|NCT02736188|183004647|SUPERIORITY||difference in LS means|0.78||||0.6546|TWO_SIDED|95.0|-2.65|4.22||Baseline is fit into the model as a covariate.|GEE model|||Week 8||4.22|-2.65|0.6546
91558111|NCT02736188|183004647|SUPERIORITY||difference in LS means|-0.64||||0.7054|TWO_SIDED|95.0|-3.97|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.69|-3.97|0.7054
91558112|NCT02736188|183004647|SUPERIORITY||difference in LS means|-0.5||||0.8441|TWO_SIDED|95.0|-5.45|4.45||Baseline is fit into the model as a covariate.|GEE model|||Week 24||4.45|-5.45|0.8441
91558113|NCT02736188|183004647|SUPERIORITY||difference in LS means|4.15||||0.0864|TWO_SIDED|95.0|-0.59|8.9||Baseline is fit into the model as a covariate.|GEE model|||Week 48||8.90|-0.59|0.0864
91558114|NCT02736188|183004648|SUPERIORITY||difference in LS means|0.06||||0.8603|TWO_SIDED|95.0|-0.65|0.78||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.78|-0.65|0.8603
91558115|NCT02736188|183004648|SUPERIORITY||difference in LS means|-0.18||||0.6154|TWO_SIDED|95.0|-0.86|0.51||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.51|-0.86|0.6154
91558116|NCT02736188|183004648|SUPERIORITY||difference in LS means|0.47||||0.1999|TWO_SIDED|95.0|-0.25|1.2||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.20|-0.25|0.1999
91558117|NCT02736188|183004648|SUPERIORITY||difference in LS means|-0.03||||0.9568|TWO_SIDED|95.0|-1.25|1.18||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.18|-1.25|0.9568
91558118|NCT02736188|183004649|SUPERIORITY||difference in LS means|0.45||||0.5447|TWO_SIDED|95.0|-1.0|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.90|-1.00|0.5447
91558119|NCT02736188|183004649|SUPERIORITY||difference in LS means|-0.56||||0.5051|TWO_SIDED|95.0|-2.22|1.09||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.09|-2.22|0.5051
91558120|NCT02736188|183004649|SUPERIORITY||difference in LS means|0.27||||0.7478|TWO_SIDED|95.0|-1.36|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.90|-1.36|0.7478
91558121|NCT02736188|183004649|SUPERIORITY||difference in LS means|-0.41||||0.7429|TWO_SIDED|95.0|-2.86|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 48||2.04|-2.86|0.7429
91558122|NCT02736188|183004650|SUPERIORITY||difference in LS means|2.0||||0.6434|TWO_SIDED|95.0|-6.48|10.49||Baseline is fit into the model as a covariate.|GEE model|||Week 8||10.49|-6.48|0.6434
91558123|NCT02736188|183004650|SUPERIORITY||difference in LS means|-1.99||||0.7118|TWO_SIDED|95.0|-12.53|8.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||8.55|-12.53|0.7118
91558124|NCT02736188|183004650|SUPERIORITY||difference in LS means|4.15||||0.4399|TWO_SIDED|95.0|-6.39|14.69||Baseline is fit into the model as a covariate.|GEE model|||Week 24||14.69|-6.39|0.4399
91558125|NCT02736188|183004650|SUPERIORITY||difference in LS means|7.98||||0.443|TWO_SIDED|95.0|-12.41|28.37||Baseline is fit into the model as a covariate.|GEE model|||Week 48||28.37|-12.41|0.4430
91558126|NCT02736188|183004651|SUPERIORITY||difference in LS means|0.28||||0.6428|TWO_SIDED|95.0|-0.9|1.46||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.46|-0.90|0.6428
91558127|NCT02736188|183004651|SUPERIORITY||difference in LS means|-0.25||||0.7334|TWO_SIDED|95.0|-1.72|1.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.21|-1.72|0.7334
91558128|NCT02736188|183004651|SUPERIORITY||difference in LS means|0.58||||0.4409|TWO_SIDED|95.0|-0.89|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.04|-0.89|0.4409
91558129|NCT02736188|183004651|SUPERIORITY||difference in LS means|0.99||||0.4687|TWO_SIDED|95.0|-1.69|3.68||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.68|-1.69|0.4687
91558130|NCT02736188|183004652|SUPERIORITY||difference in LS means|1.14||||0.1502|TWO_SIDED|95.0|-0.41|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 8||2.69|-0.41|0.1502
91558131|NCT02736188|183004652|SUPERIORITY||difference in LS means|-0.2||||0.8188|TWO_SIDED|-1.89|-1.89|1.49||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.49|-1.89|0.8188
91558132|NCT02736188|183004652|SUPERIORITY||difference in LS means|0.8||||0.5122|TWO_SIDED|95.0|-1.58|3.17||Baseline is fit into the model as a covariate.|GEE model|||Week 24||3.17|-1.58|0.5122
91558133|NCT02736188|183004652|SUPERIORITY||difference in LS means|0.72||||0.7022|TWO_SIDED|95.0|-2.96|4.4||Baseline is fit into the model as a covariate.|GEE model|||Week 48||4.40|-2.96|0.7022
91558134|NCT02736188|183004653|SUPERIORITY||difference in LS means|0.19||||0.7906|TWO_SIDED|95.0|-1.22|1.6||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.60|-1.22|0.7906
91558135|NCT02736188|183004653|SUPERIORITY||difference in LS means|0.66||||0.3531|TWO_SIDED|95.0|-0.74|2.07||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.07|-0.74|0.3531
91558136|NCT02736188|183004653|SUPERIORITY||difference in LS means|0.15||||0.8846|TWO_SIDED|95.0|-1.92|2.23||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.23|-1.92|0.8846
91558137|NCT02736188|183004653|SUPERIORITY||difference in LS means|2.08||||0.0168|TWO_SIDED|95.0|0.38|3.79||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.79|0.38|0.0168
91558138|NCT00768755|183004733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831||||0.3037|TWO_SIDED|95.0|0.508|1.36|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and gender (male or female). Hazard ratio (HR): the stratified Cox model was fitted, using the same stratification variables as above.||1.360|0.508|0.3037
91558139|NCT00768755|183004733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.3565|TWO_SIDED|95.0|0.58|1.546|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.546|0.580|0.3565
91558140|NCT00768755|183004734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.5785|TWO_SIDED|95.0|0.648|1.69|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.690|0.648|0.5785
91558141|NCT00768755|183004734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.449||||0.9392|TWO_SIDED|95.0|0.919|2.285|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||2.285|0.919|0.9392
91558142|NCT00768755|183004735|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.753||||0.0143|TWO_SIDED|95.0|1.047|2.935|||Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.935|1.047|0.0143
91558143|NCT00768755|183004735|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.512||||0.0665|TWO_SIDED|95.0|0.87|2.626|||Cochran-Mantel-Haenszel|||P-value was calculated using CMH test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.626|0.870|0.0665
91558144|NCT00670488|183004741|OTHER||AUC0-48hr GMR|3.26||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
91558145|NCT00670488|183004741|OTHER||AUC 0-48hr GMR|3.18||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
91558146|NCT00670488|183004742|OTHER||Cmax GMR|2.59||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
91558147|NCT00670488|183004742|OTHER||Cmax GMR|2.67||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
91558148|NCT00670488|183004743|OTHER||C48hr GMR|4.33||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
91558149|NCT00670488|183004743|OTHER||C48hr GMR|3.58||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
91558150|NCT00670488|183004746|OTHER||AUC0-168hr GMR|1.91||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
91558151|NCT00670488|183004746|OTHER||AUC 0-168hr GMR|1.54||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
91558152|NCT00670488|183004747|OTHER||Cmax GMR|1.95||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
91558153|NCT00670488|183004747|OTHER||Cmax GMR|1.33||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
91558154|NCT00670488|183004748|OTHER||C48hr GMR|1.61||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
91558155|NCT00670488|183004748|OTHER||C48hr GMR|1.86||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
91558156|NCT00670488|183004748|OTHER||C48hr GMR|1.49||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
91558157|NCT00670488|183004751|OTHER||GMR|0.133|||||TWO_SIDED|95.0|0.051|0.347||||||"pAkt Geometric Mean Ratio (GMR)~= Day 15 Geometric Mean (GM) ÷ Baseline GM"||0.347|0.051|
91558158|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRP ≥ 1.0 μg/mL||||<0.001
91558159|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-HBsAg ≥10 mIU/mL||||<0.001
91558160|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Diphtheria ≥0.1 IU/mL||||<0.001
91558161|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Tetanus ≥0.1 IU/mL||||<0.001
91558162|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PT seroresponse||||<0.001
91558163|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FHA seroresponse||||<0.001
91558164|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FIM seroresponse||||<0.001
91558165|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRN seroresponse||||<0.001
91558166|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV1 ≥1:8 dilution||||<0.001
91558167|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV2 ≥1:8 dilution||||<0.001
91558168|NCT01480258|183004839|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV3 ≥1:8 dilution||||<0.001
91558169|NCT01480258|183004840|NON_INFERIORITY|If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06||Stratification by country.|Miettinen & Nurminen|||||51.06|41.05|<0.001
91558170|NCT01480258|183004841|SUPERIORITY|If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06|||Miettinen & Nurminen|Stratification by country.||||51.06|41.05|<0.001
91558171|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.27|||<|0.001|TWO_SIDED|95.0|-5.13|2.52|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-inferiority for PRP||2.52|-5.13|<0.001
91558172|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|ifference in percentages|-0.59|||<|0.001|TWO_SIDED|95.0|-2.66|1.35|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for HBsAg||1.35|-2.66|<0.001
91558173|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.21|||<|0.001|TWO_SIDED|95.0|-2.54|-0.22|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Diptheria||-0.22|-2.54|<0.001
91558174|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.95|0.5|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Tetanus||0.50|-0.95|<0.001
91558175|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.54|||<|0.001|TWO_SIDED|95.0|-1.75|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PT||0.49|-1.75|<0.001
91558176|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.73|||<|0.001|TWO_SIDED|95.0|-3.47|-0.26|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for FHA||-0.26|-3.47|<0.001
91558177|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.42|||<|0.001|TWO_SIDED|95.0|-3.42|0.39|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PRN||0.39|-3.42|<0.001
91558178|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.51|||<|0.001|TWO_SIDED|95.0|-1.59|0.34|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV1||0.34|-1.59|<0.001
91558179|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.96|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV2||0.49|-0.96|<0.001
91558180|NCT01480258|183004842|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.16|||<|0.001|TWO_SIDED|95.0|-1.2|0.82|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV3||0.82|-1.20|<0.001
91558181|NCT01480258|183004843|NON_INFERIORITY|The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.|Geometric Mean Titre (GMT) ratio|0.8||||0.011|TWO_SIDED|95.0|0.54|1.2|||ANCOVA|||||1.20|0.54|0.011
91558182|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.7|1.4||||||ISR or systemic AE||1.4|-0.7|
91558183|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8||||||95.0|-0.3|2.0||||||ISR or V-related systemic AE||2.0|-0.3|
91768602|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-12.3||||0.279|TWO_SIDED|95.0|-30.4|5.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||5.8|-30.4|0.279
91768603|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-6.4||||0.716|TWO_SIDED|95.0|-28.2|15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||15.4|-28.2|0.716
91558184|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-0.7|6.0||||||At least 1 ISR||6.0|-0.7|
91558185|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.5|||||TWO_SIDED|95.0|-0.9|5.9||||||At least 1 solicited ISR||5.9|-0.9|
91558186|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.1|1.4||||||At least 1 systemic AE||1.4|-1.1|
91558187|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 vaccine-related systemic AE||2.2|-0.5|
91558188|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 solicited systemic AE||2.2|-0.5|
91558189|NCT01480258|183004844|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.9||||||95.0|-0.4|2.3||||||At least 1 vaccine-related solicited systemic AE||2.3|-0.4|
91558190|NCT01480258|183004845|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|8.2|||||TWO_SIDED|95.0|3.0|13.3||||||Injection-site erythema||13.3|3.0|
91558191|NCT01480258|183004845|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-1.5|8.3||||||Injection-site pain||8.3|-1.5|
91558192|NCT01480258|183004845|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|7.5||||||95.0|2.1|12.9||||||Injection-site swelling||12.9|2.1|
91558193|NCT01480258|183004846|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-2.5|0.3||||||Injection-site bruising||0.3|-2.5|
91558194|NCT01480258|183004846|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.5|1.6||||||Injection-site haemorrhage||1.6|-1.5|
91558195|NCT01480258|183004846|OTHER||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-1.2|6.4||||||Injection-site induration||6.4|-1.2|
91558196|NCT01480258|183004846|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.5||||||Injection-site nodule||1.5|-0.8|
91558197|NCT01480258|183004846|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|1.1||||||95.0|-0.4|2.7||||||Injection-site warmth||2.7|-0.4|
91558198|NCT01480258|183004847|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.3|5.7||||||Crying||5.7|-1.3|
91558199|NCT01480258|183004847|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.6|||||TWO_SIDED|95.0|-1.6|8.8||||||Decreased appetite||8.8|-1.6|
91558200|NCT01480258|183004847|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.0|5.4||||||Irritability||5.4|-1.0|
91558201|NCT01480258|183004847|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|6.4|||||TWO_SIDED|95.0|1.5|11.3||||||Pyrexia||11.3|1.5|
91558202|NCT01480258|183004847|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|5.8|||||TWO_SIDED|95.0|1.7|9.8||||||Somnolence||9.8|1.7|
91558203|NCT01480258|183004847|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.9||||||Vomiting||6.9|-3.2|
91558204|NCT01543204|183004863|SUPERIORITY_OR_OTHER||Difference|10.0||||0.4505|TWO_SIDED|95.0|-15.97|35.97|||Wald asymptotic test|||||35.97|-15.97|0.4505
91558205|NCT02684136|183004893|SUPERIORITY||||||<|0.05|||||||ANCOVA|baseline used as covariate||||||<0.05
91558206|NCT02684136|183004894|SUPERIORITY||||||<|0.05||||||baseline used as covariate|ANCOVA|||||||<0.05
91558207|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Erythema||0.141|-0.216|
91558208|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Swelling||0.141|-0.216|
91558209|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|ALT Increased||0.119|-0.135|
91558210|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Hemoglobin Decreased||0.119|-0.135|
91558211|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.205|0.121|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Leukocytosis||0.121|-0.205|
91558212|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.127|0.111|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|PTT Prolonged||0.111|-0.127|
91558213|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.056|||||TWO_SIDED|95.0|0.022|0.134|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Thrombocytopenia||0.134|0.022|
91558214|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.051|||||TWO_SIDED|95.0|0.018|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fever||0.118|0.018|
91558215|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.203|0.089|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Headache||0.089|-0.203|
91558216|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.166|||||TWO_SIDED|95.0|0.016|0.275|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Rash||0.275|0.016|
91558217|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|0.03|0.126|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Arthralgia||0.126|0.030|
91558218|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.023|||||TWO_SIDED|95.0|-0.155|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fatigue||0.118|-0.155|
91558219|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.041|||||TWO_SIDED|95.0|-0.105|0.105|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Myalgia||0.105|-0.105|
91558220|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.019|||||TWO_SIDED|95.0|-0.16|0.114|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Nausea||0.114|-0.160|
91558221|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Photophobia||0.141|-0.216|
91558222|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.142|0.088|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Retro-orbital Pain||0.088|-0.142|
91558223|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Decrease in Activity||0.141|-0.216|
91558224|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Loss of Appetite||0.141|-0.216|
91558225|NCT02678455|183005010|SUPERIORITY||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.165|0.218|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Vomiting||0.218|-0.165|
91558226|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|76.0|88.0||||||All study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|76|
91558227|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|99.0|||||TWO_SIDED|95.0|96.0|100.0||||||All study participants seropositive to DENV-2 post TV005 Vaccination. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|96|
91558228|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm|percentage seropositive|96.0|||||TWO_SIDED|95.0|92.0|98.0||||||All study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|92|
91558229|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|87.0|||||TWO_SIDED|95.0|81.0|92.0||||||All study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|81|
91558230|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558231|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558232|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558233|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558234|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
91558235|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
91558236|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558237|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558238|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
91558239|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
91558240|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
91558241|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
91558242|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||Young Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
91558243|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Young Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
91558244|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Young Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558245|NCT02678455|183005011|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|82.0|98.0||||||Young Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|82|
91558246|NCT02678455|183005013|SUPERIORITY||||||<|0.001||||||Comparison between experienced vs dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-1 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||<0.001
91558247|NCT02678455|183005013|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-2 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
91558248|NCT02678455|183005013|SUPERIORITY|||||||0.07||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-3 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||0.070
91558249|NCT02678455|183005013|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-4 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
91558250|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
91558251|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adult cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
91558252|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
91558253|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
91558254|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
91558255|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
91558256|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
91558257|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adult cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
91558258|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-2 at stud day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
91558259|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558260|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 180. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
91558261|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
91558262|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558263|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558264|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adult cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
91558265|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
91558266|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558267|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
91558268|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558269|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
91558270|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
91558271|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|20.0|||||TWO_SIDED|95.0|10.0|36.0||||||Adult cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||36|10|
91558272|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adult cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
91558273|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
91558274|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adult cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
91558275|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
91558276|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adult cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
91558277|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|63.0|||||TWO_SIDED|95.0|46.0|77.0||||||Adult cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||77|46|
91558278|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|26.0|||||TWO_SIDED|95.0|14.0|42.0||||||Adolescent cohort: percent seropositive to DENV-1 a study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||42|14|
91558279|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
91558280|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
91558281|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
91558282|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
91558283|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
91558284|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|46.0|||||TWO_SIDED|95.0|30.0|62.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||62|30|
91558285|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|34.0|||||TWO_SIDED|95.0|21.0|51.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||51|21|
91558286|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
91558287|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558288|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558289|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|85.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558290|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
91558291|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
91558292|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|37.0|||||TWO_SIDED|95.0|23.0|54.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|23|
91558293|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
91558294|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
91558295|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
91558296|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
91558297|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
91558298|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
91558299|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|0.0|||||TWO_SIDED|95.0|0.0|10.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||10|0|
91558300|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
91558301|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
91558302|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
91558303|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
91558304|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
91558305|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
91768604|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-27.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.1|-27.5|1.000
91558306|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||Children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
91558307|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
91558308|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|61.0|||||TWO_SIDED|95.0|45.0|75.0||||||Children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||75|45|
91558309|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
91558310|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
91558311|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
91558312|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|54.0||||||Children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|22|
91558313|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|33.0|||||TWO_SIDED|95.0|20.0|50.0||||||Children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||50|20|
91558314|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558315|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||Children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
91558316|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558317|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
91558318|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
91558319|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|58.0|||||TWO_SIDED|95.0|42.0|73.0||||||Children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||73|42|
91558320|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|52.0||||||Children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||52|22|
91558321|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558322|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
91558323|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
91558324|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
91558325|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
91558326|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
91558327|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
91558328|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
91558329|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
91558330|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|44.0|||||TWO_SIDED|95.0|30.0|60.0||||||children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||60|30|
91558331|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
91558332|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||Children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
91558333|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|19.0|||||TWO_SIDED|95.0|10.0|35.0||||||children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||35|10|
91558334|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
91558335|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Young children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
91558336|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||young children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
91558337|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|53.0|||||TWO_SIDED|95.0|37.0|68.0||||||young children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||68|37|
91558338|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
91558339|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
91558340|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
91558341|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
91558342|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Young children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
91558343|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||young children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558344|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Young children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
91558345|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||young children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
91558346|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|Slope|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||young children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
91558347|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Young children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
91558348|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|8.0|||||TWO_SIDED|95.0|3.0|22.0||||||Young children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||22|3|
91558349|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Young children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
91558350|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||young children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
91558351|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|50.0|||||TWO_SIDED|95.0|34.0|66.0||||||young children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||66|34|
91558352|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
91558353|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||young children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
91558354|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
91558355|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|3.0|||||TWO_SIDED|95.0|0.0|14.0||||||young children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||14|0|
91558356|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
91558357|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|56|
91558358|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|47.0|||||TWO_SIDED|95.0|32.0|63.0||||||young children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||63|32|
91558359|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
91558360|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
91558361|NCT02678455|183005014|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|22.0|||||TWO_SIDED|95.0|12.0|38.0||||||young children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||38|12|
91558362|NCT04938453|183005057|OTHER||Ratio of GLSMs (%)|98.47|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|90.87|106.69|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.69|90.87|
91558363|NCT04938453|183005058|OTHER||Ratio of GLSMs (%)|100.29|STANDARD_ERROR_OF_MEAN|29.2|||TWO_SIDED|90.0|85.05|118.24|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||118.24|85.05|
91558364|NCT04938453|183005059|OTHER||Ratio of GLSMs (%)|98.92|STANDARD_ERROR_OF_MEAN|13.8|||TWO_SIDED|90.0|91.35|107.12|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.12|91.35|
91768605|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||7.1|-23.5|0.400
91768606|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-19.6|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.0|-19.6|1.000
91558365|NCT00308308|183005117|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|95.0|0.08|0.4|||ANCOVA|||||0.40|0.08|
91558366|NCT00308308|183005118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-2.7|-1.0|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-1.0|-2.7|<0.0001
91558367|NCT00308308|183005119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|7.41||0.0052|TWO_SIDED|95.0|-35.4|-6.3|||ANCOVA|||||-6.3|-35.4|0.0052
91558368|NCT00308308|183005120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.941||||0.8311|TWO_SIDED|95.0|0.536|1.652|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.652|0.536|0.8311
91558369|NCT00308308|183005121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0124|TWO_SIDED|95.0|0.278|0.856|||Regression, Logistic||Model: Treatment + Site|||0.856|0.278|0.0124
91558370|NCT00308308|183005122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.825||||0.2786|TWO_SIDED|95.0|0.582|1.169|||Regression, Logistic||Model: Treatment + Site|||1.169|0.582|0.2786
91558371|NCT00308308|183005123|SUPERIORITY_OR_OTHER|||||||0.1193|||||||Generalized Estimation Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.1193
91558372|NCT00308308|183005124|SUPERIORITY_OR_OTHER|||||||0.2131|||||||Generalized Estimating Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.2131
91558373|NCT03068312|183005125|OTHER||Least squares mean difference|-0.66|||||TWO_SIDED|95.0|-1.1|-0.21||||||||-0.21|-1.10|
91558374|NCT01852045|183005128|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.276||0.9949|TWO_SIDED|95.0|-0.549|0.545|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.545|-0.549|0.9949
91558375|NCT01852045|183005128|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.321||0.9123|TWO_SIDED|95.0|-0.673|0.602|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.602|-0.673|0.9123
91558376|NCT01852045|183005130|SUPERIORITY||Least Squares Mean Difference|12.97|STANDARD_ERROR_OF_MEAN|19.694||0.5117|TWO_SIDED|95.0|-26.12|52.064|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||52.064|-26.120|0.5117
91558377|NCT01852045|183005130|SUPERIORITY||Least Squares Mean Difference|65.57|STANDARD_ERROR_OF_MEAN|23.101||0.0055|TWO_SIDED|95.0|19.711|111.421|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||111.421|19.711|0.0055
91558378|NCT01852045|183005132|SUPERIORITY||Least Squares Mean Difference|-13.49|STANDARD_ERROR_OF_MEAN|19.673||0.4948|TWO_SIDED|95.0|-52.605|25.626|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||25.626|-52.605|0.4948
91558379|NCT01852045|183005132|SUPERIORITY||Least Squares Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|22.382||0.9471|TWO_SIDED|95.0|-43.012|45.991|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||45.991|-43.012|0.9471
91558380|NCT01852045|183005133|SUPERIORITY||Relative Risk|0.7||||0.2027|TWO_SIDED|95.0|0.45|1.14||P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (\<12 years or \>=12 years), baseline daytime urinary incontinence episodes (\<=6 or \>6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.14|0.45|0.2027
91558381|NCT01852045|183005133|SUPERIORITY||Relative Risk|0.8||||0.1564|TWO_SIDED|95.0|0.4|1.21||P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (\< 12 years or \>= 12 years), baseline daytime urinary incontinence episodes (\<= 6 or \> 6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.21|0.40|0.1564
91558382|NCT01852045|183005134|SUPERIORITY||Least Squares Mean Difference|-4.49|STANDARD_ERROR_OF_MEAN|7.488||0.5524|TWO_SIDED|95.0|-19.648|10.669|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||10.669|-19.648|0.5524
91558383|NCT01852045|183005134|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|10.181||0.8313|TWO_SIDED|95.0|-18.427|22.795|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||22.795|-18.427|0.8313
91558384|NCT01852045|183005135|SUPERIORITY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|5.253||0.1737|TWO_SIDED|95.0|-17.653|3.238|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||3.238|-17.653|0.1737
91558385|NCT01852045|183005135|SUPERIORITY||Least Squares Mean Difference|-14.43|STANDARD_ERROR_OF_MEAN|5.85||0.0157|TWO_SIDED|95.0|-26.061|-2.793|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||-2.793|-26.061|0.0157
91558386|NCT01640288|183005144|OTHER|t-test|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.0349|<|0.0001|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||<0.0001
91558387|NCT01640288|183005145|OTHER|t-test|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91558388|NCT01228734|183005169|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.629|||<|0.001|TWO_SIDED|95.0|0.498|0.794|||Log Rank|||||0.794|0.498|<0.001
91558389|NCT02449902|183005174|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91558390|NCT02449902|183005175|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
91558391|NCT02449902|183005176|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||ANCOVA|||||||0.0017
91558392|NCT02449902|183005177|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
91558393|NCT02449902|183005178|SUPERIORITY_OR_OTHER|||||||0.9951|TWO_SIDED||||||ANOVA|||||||0.9951
91558394|NCT02449902|183005179|SUPERIORITY_OR_OTHER|||||||0.1429|TWO_SIDED||||||Fisher Exact|||||||0.1429
91558395|NCT02449902|183005180|SUPERIORITY_OR_OTHER|||||||0.1945|TWO_SIDED||||||ANCOVA|||||||0.1945
91558396|NCT02449902|183005181|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
91558397|NCT02449902|183005182|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||ANCOVA|||||||0.1820
91558398|NCT02449902|183005183|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||ANCOVA|||||||0.0401
91558399|NCT03162614|183005190|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).||72|27|<.001
91558400|NCT03162614|183005190|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|76.0|||<|0.001|TWO_SIDED|95.0|49.0|89.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).||89|49|<.001
91558401|NCT03162614|183005190|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|64.0|||<|0.001|TWO_SIDED|95.0|37.0|79.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).||79|37|<.001
91558402|NCT03162614|183005190|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).||72|27|<.001
91558403|NCT03162614|183005190|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|29.0||||0.009|TWO_SIDED|95.0|6.0|46.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).||46|6|0.009
91558404|NCT00621842|183005205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.01|TWO_SIDED|95.0|-18.0|-12.9|||t-test, 2 sided|df=53||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-18.0|<.01
91558405|NCT00621842|183005207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.01|TWO_SIDED|95.0|-17.5|-12.9|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-17.5|<.01
91558406|NCT00621842|183005208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.49|TWO_SIDED|95.0|-1.82|0.88|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||.88|-1.82|.49
91558407|NCT00621842|183005209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.01|TWO_SIDED|95.0|-2.43|-1.68|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-1.68|-2.43|<.01
91558408|NCT00621842|183005210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8|TWO_SIDED|95.0|-0.36|0.28|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.28|-.36|.80
91558409|NCT00621842|183005211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.36||95.0|-0.97|2.62|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||2.62|-.97|.36
91558410|NCT00621842|183005213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.09|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.09|-1.67|.08
91558411|NCT00621842|183005214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04||95.0|-1.03|-0.04|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-.04|-1.03|.04
91558412|NCT01989793|183005217|EQUIVALENCE|Equivalence margin=0||||||0.97|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 8||||0.97
91558413|NCT01989793|183005218|EQUIVALENCE|Equivalence margin=0||||||0.48|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 16||||0.48
91558414|NCT01989793|183005219|EQUIVALENCE|Equivalence margin = 0||||||0.59|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 24||||0.59
91558415|NCT01989793|183005220|EQUIVALENCE|Equivalence margin=0||||||0.212|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 8||||0.212
91558416|NCT01989793|183005221|EQUIVALENCE|Equivalence margin=0||||||0.271|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 16||||0.271
91558417|NCT01989793|183005222|EQUIVALENCE|Equivalence margin=0||||||0.203|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 24||||0.203
91558418|NCT01989793|183005223|EQUIVALENCE|Equivalence margin = 0||||||0.82|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.82
91558419|NCT01989793|183005224|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
91558420|NCT01989793|183005225|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
91558421|NCT01957163|183005228|SUPERIORITY_OR_OTHER||Least squared mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.093|0.154|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.154|0.093|< 0.001
91558422|NCT01957163|183005228|SUPERIORITY_OR_OTHER||Least squared mean difference|0.128|||<|0.001|TWO_SIDED|95.0|0.098|0.159|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.159|0.098|<0.001
91558423|NCT01957163|183005229|SUPERIORITY_OR_OTHER||Least squared mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.118|0.187|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.187|0.118|<0.001
91558424|NCT01957163|183005229|SUPERIORITY_OR_OTHER||Least squared mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.106|0.175|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.175|0.106|<0.001
91558425|NCT03822832|183005233|OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|17.4||0.1492|TWO_SIDED|90.0|-54.9|3.7|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||3.7|-54.9|0.1492
91558426|NCT03822832|183005235|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.8613|TWO_SIDED|90.0|-5.7|7.0|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||7.0|-5.7|0.8613
91558427|NCT03822832|183005236|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|14.0||0.8754|TWO_SIDED|90.0|-25.8|21.4|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||21.4|-25.8|0.8754
91558428|NCT03822832|183005237|OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|90.0|-0.254|0.176||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.176|-0.254|
91558429|NCT03822832|183005237|OTHER||Risk Difference (RD)|0.247|||||TWO_SIDED|90.0|0.053|0.396||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.396|0.053|
91558430|NCT03822832|183005238|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.204|0.117||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.117|-0.204|
91558431|NCT03822832|183005238|OTHER||Risk Difference (RD)|0.096|||||TWO_SIDED|90.0|-0.08|0.232||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Pl|Risk difference at week 16||0.232|-0.080|
91558432|NCT03822832|183005239|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.7||0.99|TWO_SIDED|90.0|-14.6|14.8|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||14.8|-14.6|0.9900
91558433|NCT03822832|183005240|OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|12.1||0.2266|TWO_SIDED|90.0|-35.2|5.5|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||5.5|-35.2|0.2266
91558434|NCT03822832|183005241|OTHER||Risk Difference (RD)|0.005|||||TWO_SIDED|90.0|-0.159|0.12||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.120|-0.159|
91558435|NCT03822832|183005241|OTHER||Risk Difference (RD)|0.091|||||TWO_SIDED|90.0|-0.05|0.207||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.207|-0.050|
91558436|NCT01321073|183005251|SUPERIORITY||||||<|0.0001|||||||1-sample exact test for Poisson rate|||The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.||||<0.0001
91768607|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|7.9||||0.62|TWO_SIDED|95.0|-22.2|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||38.0|-22.2|0.620
91768608|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.1|-23.5|0.400
91558437|NCT01638000|183005252|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was \> -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.|least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.124||0.15|TWO_SIDED|95.0|-0.42|0.06||If p\<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.||0.06|-0.42|0.15
91558438|NCT01638000|183005253|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.25||If P \<0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.|Regression, Logistic|Included treatment group, sex, age group (\< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.||Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.||2.25|1.04|0.030
91558439|NCT01638000|183005254|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.117||0.71|TWO_SIDED|95.0|-0.19|0.27||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.27|-0.19|0.71
91558440|NCT01638000|183005254|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.119||0.053|TWO_SIDED|95.0|-0.47|0.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.47|0.053
91558441|NCT01638000|183005254|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.125||0.12|TWO_SIDED|95.0|-0.44|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.44|0.12
91558442|NCT01638000|183005255|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.9||||0.33|TWO_SIDED|95.0|0.73|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron.||1.11|0.73|0.33
91558443|NCT01638000|183005255|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron.||1.10|0.64|0.21
91558444|NCT01638000|183005255|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.83|TWO_SIDED|95.0|0.71|1.32||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron.||1.32|0.71|0.83
91558445|NCT01638000|183005255|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.57|TWO_SIDED|95.0|0.68|1.24||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.24|0.68|0.57
91558446|NCT01638000|183005256|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.089||0.36|TWO_SIDED|95.0|-0.25|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.25|0.36
91558447|NCT01638000|183005256|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.12|TWO_SIDED|95.0|-0.48|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.48|0.12
91558448|NCT01638000|183005256|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.163||0.47|TWO_SIDED|95.0|-0.57|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.07|-0.57|0.47
91558449|NCT01638000|183005257|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.44|TWO_SIDED|95.0|0.74|1.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.14|0.74|0.44
91558450|NCT01638000|183005257|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79||||0.11|TWO_SIDED|95.0|0.6|1.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 8 Rate Ratio vs. Mirabegron||1.06|0.60|0.11
91558451|NCT01638000|183005257|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.78|TWO_SIDED|95.0|0.76|1.45||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron||1.45|0.76|0.78
91558452|NCT01638000|183005257|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.85|TWO_SIDED|95.0|0.71|1.33||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Final Visit Rate Ratio vs. Mirabegron||1.33|0.71|0.85
91558453|NCT01638000|183005258|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.081||0.66|TWO_SIDED|95.0|-0.18|0.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.14|-0.18|0.66
91558454|NCT01638000|183005258|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.17|TWO_SIDED|95.0|-0.31|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.03|-0.31|0.17
91558455|NCT01638000|183005258|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.66|TWO_SIDED|95.0|-0.24|0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.02|-0.24|0.66
91558456|NCT01638000|183005259|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.19|-0.44|0.43
91558457|NCT01638000|183005259|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.157||0.027|TWO_SIDED|95.0|-0.66|-0.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.04|-0.66|0.027
91558458|NCT01638000|183005259|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.164||0.053|TWO_SIDED|95.0|-0.64|0.0|||ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.64|0.053
91558459|NCT01638000|183005259|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.16|TWO_SIDED|95.0|-0.55|0.09||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.09|-0.55|0.16
91558460|NCT01638000|183005260|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.99|TWO_SIDED|95.0|-0.05|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.05|0.99
91558461|NCT01638000|183005260|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027||0.47|TWO_SIDED|95.0|-0.07|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.07|0.47
91558462|NCT01638000|183005260|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.06|0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.06|-0.06|0.99
91768609|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-4.3||||1|TWO_SIDED|95.0|-22.7|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.2|-22.7|1.000
91768610|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|4.0||||1|TWO_SIDED|95.0|-18.7|26.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.6|-18.7|1.000
91558463|NCT01638000|183005260|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.031||0.74|TWO_SIDED|95.0|-0.05|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.07|-0.05|0.74
91558464|NCT01638000|183005261|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.20|0.89|0.67
91558465|NCT01638000|183005261|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.17||||0.073|TWO_SIDED|95.0|0.99|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.39|0.99|0.073
91558466|NCT01638000|183005261|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.12||||0.25|TWO_SIDED|95.0|0.92|1.37||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.37|0.92|0.25
91558467|NCT01638000|183005261|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.08||||0.4|TWO_SIDED|95.0|0.9|1.31||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.31|0.90|0.40
91558468|NCT01638000|183005262|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.115||0.84|TWO_SIDED|95.0|-0.25|0.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.20|-0.25|0.84
91558469|NCT01638000|183005262|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.099||0.63|TWO_SIDED|95.0|-0.24|0.15||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.15|-0.24|0.63
91558470|NCT01638000|183005262|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.59|TWO_SIDED|95.0|-0.28|0.16||if p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.16|-0.28|0.59
91558471|NCT01638000|183005263|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.068|TWO_SIDED|95.0|1.0|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.11|1.00|0.068
91768611|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|5.0||||0.678|TWO_SIDED|95.0|-9.7|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.6|-9.7|0.678
91768612|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|7.9||||0.636|TWO_SIDED|95.0|-10.5|26.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.2|-10.5|0.636
91558472|NCT01638000|183005263|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.04||||0.21|TWO_SIDED|95.0|0.98|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.11|0.98|0.21
91558473|NCT01638000|183005263|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.02||||0.52|TWO_SIDED|95.0|0.95|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.10|0.95|0.52
91558474|NCT01638000|183005263|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.44|TWO_SIDED|95.0|0.96|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.10|0.96|0.44
91558475|NCT01638000|183005264|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.047||0.058|TWO_SIDED|95.0|0.0|0.18||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.18|-0.00|0.058
91558476|NCT01638000|183005264|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.5|TWO_SIDED|95.0|-0.06|0.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.12|-0.06|0.50
91558477|NCT01638000|183005264|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.81|TWO_SIDED|95.0|-0.08|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.08|0.81
91558478|NCT01638000|183005265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.67|TWO_SIDED|95.0|0.85|1.28||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds ratio vs. Mirabegron||1.28|0.85|0.67
91558479|NCT01638000|183005265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.026|TWO_SIDED|95.0|1.03|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds ratio vs. Mirabegron||1.53|1.03|0.026
91558480|NCT01638000|183005265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.11|TWO_SIDED|95.0|0.97|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds ratio vs. Mirabegron||1.44|0.97|0.11
91558481|NCT01638000|183005265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.093|TWO_SIDED|95.0|0.97|1.43||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final Visit Odds ratio vs. Mirabegron||1.43|0.97|0.093
91558482|NCT01638000|183005266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.74|TWO_SIDED|95.0|0.76|1.48||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.48|0.76|0.74
91558483|NCT01638000|183005266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.74|TWO_SIDED|95.0|0.71|1.63||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.63|0.71|0.74
91768613|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|21.4||||0.19|TWO_SIDED|95.0|-9.7|52.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||52.5|-9.7|0.190
91768614|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|9.0||||0.504|TWO_SIDED|95.0|-17.3|35.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||35.3|-17.3|0.504
91768615|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|1.6||||0.916|TWO_SIDED|95.0|-27.8|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||31.0|-27.8|0.916
91558484|NCT01638000|183005266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.29|TWO_SIDED|95.0|0.81|2.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||2.00|0.81|0.29
91558485|NCT01638000|183005266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.29|TWO_SIDED|95.0|0.82|1.9||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.90|0.82|0.29
91558486|NCT01638000|183005267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.2|TWO_SIDED|95.0|0.9|1.67||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.67|0.90|0.20
91558487|NCT01638000|183005267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.57|TWO_SIDED|95.0|0.65|1.26||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.26|0.65|0.57
91558488|NCT01638000|183005267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.92|TWO_SIDED|95.0|0.69|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.39|0.69|0.92
91558489|NCT01638000|183005267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.73|1.42||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.42|0.73|0.90
91558490|NCT01638000|183005288|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.817||0.039|TWO_SIDED|95.0|-3.29|-0.08||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.08|-3.29|0.039
91558491|NCT01638000|183005288|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.849||0.034|TWO_SIDED|95.0|-3.46|-0.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.13|-3.46|0.034
91558492|NCT01638000|183005288|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.917||0.022|TWO_SIDED|95.0|-3.9|-0.3||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.30|-3.90|0.022
91558493|NCT01638000|183005288|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.924||0.043|TWO_SIDED|95.0|-3.68|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-3.68|0.043
91558494|NCT01638000|183005289|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.14|STANDARD_ERROR_OF_MEAN|0.77||0.14|TWO_SIDED|95.0|-0.37|2.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||2.65|-0.37|0.14
91558495|NCT01638000|183005289|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.805||0.055|TWO_SIDED|95.0|-0.03|3.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.13|-0.03|0.055
91558496|NCT01638000|183005289|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.866||0.074|TWO_SIDED|95.0|-0.15|3.25||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.25|-0.15|0.074
91558497|NCT01638000|183005289|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.41|STANDARD_ERROR_OF_MEAN|0.873||0.11|TWO_SIDED|95.0|-0.3|3.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.12|-0.30|0.11
91558498|NCT01638000|183005290|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.07|TWO_SIDED|95.0|-0.19|0.01||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.01|-0.19|0.070
91558499|NCT01638000|183005290|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.054||0.003|TWO_SIDED|95.0|-0.27|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-0.27|0.003
91558500|NCT01638000|183005290|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.015|TWO_SIDED|95.0|-0.26|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.03|-0.26|0.015
91558501|NCT01638000|183005290|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.059||0.021|TWO_SIDED|95.0|-0.25|-0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.02|-0.25|0.021
91558502|NCT01638000|183005291|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.141||0.002|TWO_SIDED|95.0|0.15|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.15|0.002
91558503|NCT01638000|183005291|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|0.14|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.14|0.003
91558504|NCT01638000|183005292|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean diffrence|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|0.02|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.02|0.027
91558505|NCT01638000|183005292|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.071||0.034|TWO_SIDED|95.0|0.01|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.01|0.034
91558506|NCT01638000|183005293|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.01|TWO_SIDED|95.0|1.08|1.81||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.81|1.08|0.010
91558507|NCT01638000|183005293|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|1.07|1.75||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.75|1.07|0.011
91558508|NCT01638000|183005294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.037|TWO_SIDED|95.0|1.02|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.62|1.02|0.037
91768616|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-31.7|31.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||31.7|-31.7|1.000
91558509|NCT01638000|183005294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.045|TWO_SIDED|95.0|1.01|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.57|1.01|0.045
91558510|NCT01638000|183005295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.009|TWO_SIDED|95.0|1.11|2.06||Iif p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥1 point improvement) Odds Rato vs. Mirabegron||2.06|1.11|0.009
91558511|NCT01638000|183005295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.065|TWO_SIDED|95.0|0.99|1.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥2 point improvement) Odds Rato vs. Mirabegron||1.65|0.99|0.065
91558512|NCT01638000|183005295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.051|TWO_SIDED|95.0|1.0|1.55||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥3 point improvement) Odds Rato vs. Mirabegron||1.55|1.00|0.051
91558513|NCT01638000|183005295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.14|TWO_SIDED|95.0|0.95|1.47||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥4 point improvement) Odds Rato vs. Mirabegron||1.47|0.95|0.14
91558514|NCT01638000|183005295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.89|TWO_SIDED|95.0|0.75|1.4||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥5 point improvement) Odds Rato vs. Mirabegron||1.40|0.75|0.89
91558515|NCT01638000|183005295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Week 12 (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
91558516|NCT01638000|183005296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.016|TWO_SIDED|95.0|1.07|1.93||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥1 point improvement) Odds Rato vs. Mirabegron||1.93|1.07|0.016
91558517|NCT01638000|183005296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.063|TWO_SIDED|95.0|0.99|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥2 point improvement) Odds Rato vs. Mirabegron||1.62|0.99|0.063
91558518|NCT01638000|183005296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.054|TWO_SIDED|95.0|1.0|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥3 point improvement) Odds Rato vs. Mirabegron||1.53|1.00|0.054
91558519|NCT01638000|183005296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.46||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥4 point improvement) Odds Rato vs. Mirabegron||1.46|0.95|0.15
91558520|NCT01638000|183005296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.75|TWO_SIDED|95.0|0.77|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥5 point improvement) Odds Rato vs. Mirabegron||1.44|0.77|0.75
91558521|NCT01638000|183005296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Final visit (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
91558522|NCT01638000|183005297|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.082|TWO_SIDED|95.0|0.97|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.57|0.97|0.082
91558523|NCT01638000|183005297|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.15|TWO_SIDED|95.0|0.94|1.49||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.49|0.94|0.15
91558524|NCT01638000|183005298|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.058|TWO_SIDED|95.0|0.99|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.53|0.99|0.058
91558525|NCT01638000|183005298|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.069|TWO_SIDED|95.0|0.99|1.5||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.50|0.99|0.069
91558526|NCT04248803|183005299|NON_INFERIORITY|From the above mentioned non inferiority clinical trial it is hypothesized that GLUMA application will reduce postoperative sensitivity during dental restorative procedures.||||||0.05|||||||Kruskal-Wallis|||The sample size was estimated to be 504 using G Power software with 95% power and alpha value set to 0.05. The participants were randomly divided to 6 groups with randomizer.org. The statistical analysis was carried out using SPSS 23 software to compare the mean pain scores between the six study groups using kruskal Wallis test.||||0.05
91558527|NCT03775213|183005331|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.91|2.58||||||||2.58|.91|
91558528|NCT03775213|183005332|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.88||||||Active Monitoring||1.88|.49|
91558529|NCT03775213|183005332|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.79|1.41||||||Lumpectomy||1.41|.79|
91558530|NCT03775213|183005332|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||Lumpectomy with Radiation||1.30|.62|
91558531|NCT03775213|183005332|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.48|1.47||||||Mastectomy||1.47|.48|
91558532|NCT03775213|183005333|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.59|1.98||||||||1.98|.59|
91558533|NCT03775213|183005334|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.65|1.45||||||||1.45|.65|
91558534|NCT03775213|183005335|SUPERIORITY||Slope|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||||.38|-.20|
91558535|NCT00786188|183005352|SUPERIORITY_OR_OTHER|||||||0.0177||||||Week 4 frequency|Repeated measures analysis|||||||0.0177
91558536|NCT00786188|183005352|SUPERIORITY_OR_OTHER|||||||0.0541||||||Week 8 frequency|Reapeated measures analysis|||||||0.0541
91558537|NCT00786188|183005353|SUPERIORITY_OR_OTHER|||||||0.0644||||||Week 4 severity|Reapeated measures analysis|||||||0.0644
91558538|NCT00786188|183005353|SUPERIORITY_OR_OTHER|||||||0.0364||||||Week 8 severity|Reapeated measures analysis|||||||0.0364
91558539|NCT01000805|183005458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This p-value is for the main effect of treatment.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
91558540|NCT01000805|183005459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.83|-2.24|||Mixed Models Analysis|||||-2.24|-5.83|<0.001
91558541|NCT01000805|183005460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.112|TWO_SIDED|95.0|-1.03|0.11||This is the p-value for the Disrupt Work/School Work score.|Mixed Models Analysis|||||0.11|-1.03|0.112
91558542|NCT01000805|183005460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.005|TWO_SIDED|95.0|-1.24|-0.22||This the p-value for the Disrupt Social Life/Leisure score.|Mixed Models Analysis|||||-0.22|-1.24|0.005
91558543|NCT01000805|183005460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04|TWO_SIDED|95.0|-1.04|-0.02||This is the p-value for the Disrupt Family Life/Home score.|Mixed Models Analysis|||||-0.02|-1.04|0.040
91558544|NCT01000805|183005460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.019|TWO_SIDED|95.0|-3.2|-0.29||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.29|-3.20|0.019
91558545|NCT01000805|183005461|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.001
91558546|NCT01000805|183005462|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||This is the third gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.0082
91558547|NCT01000805|183005463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||<|0.001|TWO_SIDED|95.0|-5.2|-2.11||This is the fourth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-2.11|-5.20|<0.001
91558548|NCT01000805|183005464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||0.001|TWO_SIDED|95.0|-3.5|-0.89||This is the fifth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.89|-3.50|0.001
91558549|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.97|-0.32||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.32|-0.97|<0.001
91558550|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.34||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.34|-0.90|<0.001
91558551|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
91558552|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.06|-0.42||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.42|-1.06|<0.001
91558553|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.03|-0.33||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-1.03|<0.001
91558554|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.09|-0.37||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.37|-1.09|<0.001
91558555|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.009|TWO_SIDED|95.0|-0.79|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.79|0.009
91558556|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002|TWO_SIDED|95.0|-0.91|-0.21||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.21|-0.91|0.002
91558557|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.06|-0.35||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.35|-1.06|<0.001
91558558|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.042|TWO_SIDED|95.0|-0.76|-0.01||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.01|-0.76|0.042
91558559|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.03|-0.31||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.31|-1.03|<0.001
91558560|NCT01000805|183005465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.88|-0.25||This is the p-value for the main effect of treatment for the BPI Mean Pain Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.25|-0.88|<0.001
91558561|NCT01000805|183005466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.71|-0.26||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.26|-0.71|<0.001
91558562|NCT01000805|183005467|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for suicidal ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.293
91558563|NCT01000805|183005468|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.033
91558564|NCT01000805|183005469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.92|||<|0.001|TWO_SIDED|95.0|1.34|4.51||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.51|1.34|<0.001
91558565|NCT01000805|183005469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.001|TWO_SIDED|95.0|0.97|3.83||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.83|0.97|0.001
91558566|NCT01000805|183005470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.083|TWO_SIDED|95.0|-0.25|4.04||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.04|-0.25|0.083
91558567|NCT01000805|183005470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.513|TWO_SIDED|95.0|-0.95|1.9||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||1.90|-0.95|0.513
91558568|NCT01000805|183005470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.124|TWO_SIDED|95.0|-0.42|3.47||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.47|-0.42|0.124
91558569|NCT01000805|183005470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.638|TWO_SIDED|95.0|-0.98|1.6||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||1.60|-0.98|0.638
91558570|NCT01000805|183005471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.54||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.54|-1.37|<0.001
91558571|NCT01000805|183005471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.51|-1.24|<0.001
91558572|NCT03769090|183005520|SUPERIORITY||Hazard Ratio (HR)|0.733|||<|0.001|TWO_SIDED|95.0|0.611|0.879|||Regression, Cox|||H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.||0.879|0.611|<0.001
91558573|NCT03769090|183005520|SUPERIORITY||Hazard Ratio (HR)|0.835||||0.041|TWO_SIDED|95.0|0.702|0.992|||Regression, Cox|||H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.||0.992|0.702|0.041
91558574|NCT03769090|183005521|SUPERIORITY||Rate Ratio|0.76||||0.008|TWO_SIDED|95.0|0.62|0.93|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.93|0.62|0.008
91558575|NCT03769090|183005521|SUPERIORITY||Rate Ratio|0.8||||0.028|TWO_SIDED|95.0|0.66|0.98|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.98|0.66|0.028
91558576|NCT03769090|183005522|SUPERIORITY|||||||0.002|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.002
91558577|NCT03769090|183005522|SUPERIORITY|||||||0.06|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.06
91558578|NCT03769090|183005523|SUPERIORITY||Odds Ratio (OR)|1.221||||0.033|TWO_SIDED|95.0|1.016|1.467|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.467|1.016|0.033
91558579|NCT03769090|183005523|SUPERIORITY||Odds Ratio (OR)|1.132||||0.175|TWO_SIDED|95.0|0.946|1.353|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.353|0.946|0.175
91558580|NCT03769090|183005524|SUPERIORITY||Odds Ratio (OR)|1.228||||0.028|TWO_SIDED|95.0|1.022|1.475|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.475|1.022|0.028
91558581|NCT03769090|183005524|SUPERIORITY||Odds Ratio (OR)|1.111||||0.26|TWO_SIDED|95.0|0.925|1.335|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.335|0.925|0.26
91558582|NCT02786966|183005527|SUPERIORITY||Odds Ratio (OR)|0.4||||0.0007|TWO_SIDED|95.0|0.2|0.6|||Regression, Logistic|Adjusted for age and sex||||0.6|0.2|0.0007
91558583|NCT02786966|183005528|SUPERIORITY||Odds Ratio (OR)|0.61||||0.0007|TWO_SIDED|95.0|0.47|0.8|||Regression, Logistic||||Adjusted for age and sex.|0.80|0.47|0.0007
91558584|NCT02786966|183005529|SUPERIORITY||Odds Ratio (OR)|0.69||||0.0093|TWO_SIDED|95.0|0.52|0.91|||Regression, Logistic|adjusted for age and sex||||0.91|0.52|0.0093
91558585|NCT01277302|183005544|SUPERIORITY_OR_OTHER||Estimated interaction effect|0.071|STANDARD_ERROR_OF_MEAN|0.107||0.5091||||||This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p \< 0.05 (2-sided) was required for significance.|Longitudinal mixed model|The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, \>35 to ≤50, or \>50 letters).||The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.||||0.5091
91558586|NCT01190124|183005593|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline||||<0.001
91768617|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-9.0||||0.504|TWO_SIDED|95.0|-35.3|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-35.3|0.504
91768618|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-7.1||||0.635|TWO_SIDED|95.0|-36.6|22.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||22.3|-36.6|0.635
91768619|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|10.7||||0.513|TWO_SIDED|95.0|-21.1|42.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.5|-21.1|0.513
91558587|NCT01190124|183005596|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline||||<0.001
91558588|NCT01190124|183005609|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24||||0.007
91558589|NCT01190124|183005610|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48||||0.001
91558590|NCT02713594|183005612|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.86|||<|0.0001|TWO_SIDED|95.0|-11.28|-4.5|||Abstinence Risk Difference|||||-4.5|-11.28|<.0001
91558591|NCT02713594|183005613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|Chi-square test value = 196.1, with 5 degrees of freedom.||||||<.0001
91558592|NCT01523392|183005620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.6|STANDARD_ERROR_OF_MEAN|14.68|<|0.001|TWO_SIDED|95.0|-213.9|-153.3||Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence|Mixed Models Analysis||Ticagrelor minus clopidogrel|||-153.3|-213.9|<0.001
91558593|NCT01523392|183005621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.8|STANDARD_ERROR_OF_MEAN|18.79|<|0.001|TWO_SIDED|95.0|-142.5|-65.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 0.5 hours after loading dose||-65.0|-142.5|<0.001
91558594|NCT01523392|183005621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-165.3|STANDARD_ERROR_OF_MEAN|15.45|<|0.001|TWO_SIDED|95.0|-197.4|-133.3|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours after loading dose||-133.3|-197.4|<0.001
91558595|NCT01523392|183005622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.0|STANDARD_ERROR_OF_MEAN|12.35|<|0.001|TWO_SIDED|95.0|-160.4|-109.5|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-109.5|-160.4|<0.001
91558596|NCT01523392|183005622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.1|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|95.0|-143.9|-92.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours on Day 7 after multiple doses||-92.2|-143.9|<0.001
91558597|NCT01523392|183005622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-133.4|STANDARD_ERROR_OF_MEAN|12.77|<|0.001|TWO_SIDED|95.0|-159.7|-107.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at end of dosing interval on Day 8||-107.1|-159.7|<0.001
91558598|NCT01928732|183005629|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|1.0|1.65|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.||1.65|1.00|
91558599|NCT01928732|183005629|SUPERIORITY||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|1.12|1.74|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.||1.74|1.12|
91558600|NCT01928732|183005629|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|1.24|2.0|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.||2.00|1.24|
91558601|NCT01185340|183005637|SUPERIORITY_OR_OTHER|||||||0.751|||||||Mixed Models Analysis|||||||0.751
91558602|NCT01719172|183005656|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper-Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.||||<0.0001
91558603|NCT01719172|183005657|SUPERIORITY_OR_OTHER|||||||0.0214||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper-Pearson) 95% confidence interval for the true percentage was calculated.||||0.0214
91558604|NCT01719172|183005658|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||||ONE_SIDED|95.0||1.0||||||Time to achieve hemostasis was analyzed using the Kaplan-Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer-Crowley confidence interval for the median was computed based on the sign test.||1.0||
91558605|NCT00087516|183005659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-0.96|-0.62|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.62|-0.96|<0.001
91558606|NCT00087516|183005659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-1.11|-0.77|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.77|-1.11|<0.001
91558607|NCT00087516|183005660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.1|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0|-24.1|-10.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-10.1|-24.1|<0.001
91558608|NCT00087516|183005660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0|-28.2|-14.4|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-14.4|-28.2|<0.001
91558609|NCT00087516|183005661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.7|STANDARD_ERROR_OF_MEAN|6.5|<|0.001||95.0|-59.4|-34.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-34.1|-59.4|<0.001
91558610|NCT00087516|183005661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.001||95.0|-66.7|-41.6|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-41.6|-66.7|<0.001
91558611|NCT00246129|183005665|SUPERIORITY|||||||0.467|||||||Log Rank|||||||0.467
91558612|NCT00246129|183005666|SUPERIORITY|||||||0.138|||||||Log Rank|||||||0.138
91558613|NCT02005172|183005684|EQUIVALENCE|The primary analysis used the TOST procedure for equivalence. A difference of less than 10% between devices on the proportion of diagnostic days during the monitoring period was considered to be equivalent. We hypothesized that the percentage of diagnostic days for the ELR and the KM would be 20% and 15%, respectively.||||||||||||||||For the primary endpoint, equivalence testing using the two one-sided test procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence.|"Descriptive statistics (means, standard deviation (SD), percentages) were used to summarize the demographic and clinical characteristics of the patients. The total number of tracings and the percentage of tracings with arrhythmias for each device were also calculated.~For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. Patients were asked to use both devices for the same duration. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence. The primary hypothesis was that the KM"|||
91558614|NCT01711294|183005685|SUPERIORITY|Sample sizes were calculated using two-sample t-test for the primary endpoint and z-test for the secondary endpoint with power of 80% and two-sided alpha of 0.05. Hochberg step up procedure was used to adjust for multiple comparison. A p-value \< 0.05 was considered statistically significant.||||||0.84||||||Hochberg step up procedure was used to adjust for multiple comparison.|Wilcoxon (Mann-Whitney)|Wilcoxon was used instead of t-test because the data was not normally distributed.||Study hypothesizes that aspiration % in the 19G Flex and 19G arms would be superior by at least 10% to 22G arm, and aspiration success rate of 19G Flex would be at least 16% greater than 22G and 19G arms. Sample size calculation was performed based on the above hypotheses reached by a consensus of all collaborators and adjusted a priori.||||0.84
91558615|NCT02605174|183005701|SUPERIORITY||Odds Ratio (OR)|1.5||||0.003|TWO_SIDED|95.0|1.1|1.9|||Regression, Logistic|||||1.9|1.1|0.003
91558616|NCT02605174|183005701|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
91558617|NCT02605174|183005701|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
91558618|NCT02605174|183005702|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.009
91558619|NCT02605174|183005702|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0|||Regression, Logistic|||||2.0|1.2|<0.001
91558620|NCT02605174|183005702|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.4|2.4|||Regression, Logistic|||||2.4|1.4|<0.001
91558621|NCT02605174|183005703|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
91558622|NCT02605174|183005703|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|2.9|||Regression, Logistic|||||2.9|1.7|<0.001
91558623|NCT02605174|183005703|SUPERIORITY||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
91558624|NCT02605174|183005705|SUPERIORITY||Odds Ratio (OR)|0.7||||0.002|TWO_SIDED|95.0|0.5|0.9|||Regression, Logistic|||||0.9|0.5|0.002
91558625|NCT02605174|183005705|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.7|||Regression, Logistic|||||0.7|0.4|<0.001
91558626|NCT02605174|183005705|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Regression, Logistic|||||0.4|0.3|<0.001
91558627|NCT02605174|183005706|SUPERIORITY||Odds Ratio (OR)|1.0||||0.917|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|||||1.5|0.7|0.917
91558628|NCT02605174|183005706|SUPERIORITY||Odds Ratio (OR)|0.7||||0.129|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.129
91558629|NCT02605174|183005706|SUPERIORITY||Odds Ratio (OR)|0.8||||0.456|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|||||1.3|0.6|0.456
91558630|NCT02605174|183005708|SUPERIORITY||Odds Ratio (OR)|0.9||||0.522|TWO_SIDED|95.0|0.7|1.2|||Regression, Logistic|||||1.2|0.7|0.522
91558631|NCT02605174|183005708|SUPERIORITY||Odds Ratio (OR)|1.1||||0.622|TWO_SIDED|95.0|0.8|1.4|||Regression, Logistic|||||1.4|0.8|0.622
91558632|NCT02605174|183005708|SUPERIORITY||Odds Ratio (OR)|1.0||||0.992|TWO_SIDED|95.0|0.8|1.3|||Regression, Logistic|||||1.3|0.8|0.992
91558633|NCT02605174|183005709|SUPERIORITY||Odds Ratio (OR)|1.4||||0.008|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.008
91558634|NCT02605174|183005709|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0|||Regression, Logistic|||||2.0|1.3|<0.001
91558635|NCT02605174|183005709|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
91558636|NCT02605174|183005710|SUPERIORITY||Odds Ratio (OR)|1.4||||0.007|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.007
91558637|NCT02605174|183005710|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
91558638|NCT02605174|183005710|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.4|2.3|||Regression, Logistic|||||2.3|1.4|<0.001
91558639|NCT00770874|183005713|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.125
91558640|NCT00770874|183005714|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.48|0.8|||Log Rank|||||0.80|0.48|<0.001
91558641|NCT01335061|183005729|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||||||<0.0001
91558642|NCT00273052|183005743|SUPERIORITY_OR_OTHER||Median Difference (Net)|-8.026||||0.0141||95.0|-15.35|-0.67|||ANCOVA||Median difference = Coreg CR - Toprol XL|||-0.67|-15.35|0.0141
91558643|NCT00273052|183005744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.6068||95.0|-2.4|3.9|||ANCOVA||Mean difference = Coreg CR - Toprol XL|||3.9|-2.4|0.6068
91558644|NCT00240994|183005757|SUPERIORITY_OR_OTHER||Proportion with graft loss or death|0.057|||||TWO_SIDED|95.0|0.007|0.192|||95% Confidence Interval|95% CI using an exact binomial method||The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.||0.192|0.007|
91558645|NCT01482091|183005798|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
91558646|NCT01482091|183005800|SUPERIORITY_OR_OTHER||||||=|0.05|||||||Fisher Exact|||||||=0.05
91558647|NCT01482091|183005801|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91558648|NCT01482091|183005804|SUPERIORITY_OR_OTHER||||||=|0.68|||||||t-test, 2 sided|||||||=0.68
91558649|NCT01482091|183005805|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91558650|NCT01482091|183005806|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91558651|NCT01482091|183005810|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
91768620|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|1.7||||0.898|TWO_SIDED|95.0|-24.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-24.7|0.898
91768621|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-13.1||||0.379|TWO_SIDED|95.0|-41.7|15.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||15.5|-41.7|0.379
91768622|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-3.6||||0.822|TWO_SIDED|95.0|-34.5|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.4|-34.5|0.822
91558652|NCT03775915|183005811|OTHER||||||>|0.05||||||p-value calculated for interaction between group and day|Linear Mixed Model|Linear mixed effects model adjusted for baseline, F(2,46) = 1.061, p \>0.05||||||>0.05
91558653|NCT03775915|183005812|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
91558654|NCT02234141|183005834|OTHER|Nonparametric pairwise comparison|||||=|0.214||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving {1, 2, or greater than or equal to \[≥\] 3}).||||= 0.214
91558655|NCT02234141|183005834|OTHER|Nonparametric pairwise comparison|||||=|0.27||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.270
91768623|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|8.9||||0.508|TWO_SIDED|95.0|-17.3|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||35.0|-17.3|0.508
91768624|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-6.0||||0.683|TWO_SIDED|95.0|-34.3|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||22.4|-34.3|0.683
91558656|NCT02234141|183005834|OTHER|Nonparametric pairwise comparison|||||=|0.604||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test)|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.604
91558657|NCT02095678|183005857|OTHER|Significance (alpha) set to 0.05||||||0.211|||||||t-test, 2 sided|||||||0.211
91558658|NCT02095678|183005860|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91558659|NCT02095678|183005861|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91768625|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|14.3||||0.49|TWO_SIDED|95.0|-16.6|45.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||45.1|-16.6|0.490
91558660|NCT03418545|183005862|SUPERIORITY||Percentage difference|67.5|||<|0.0001|TWO_SIDED|95.0|52.9|82.0||The p-value and 95% CI are computed by pooling 5 imputed datasets using PROC MIANALYZE in SAS with normal approximation. The p-value and 95% CI for each imputed data set is based on the Fisher's exact test and the Wald test, respectively.|Fisher Exact|||||82.0|52.9|<0.0001
91558661|NCT03418545|183005863|SUPERIORITY||Percentage difference|73.5|||||TWO_SIDED|95.0|60.2|86.8|||||The 95% CI is based on the Wald test.|||86.8|60.2|
91558662|NCT03418545|183005865|SUPERIORITY||||||<|0.0001||||||A 2-sided paired t-test at the 5% level was performed to demonstrate that the mean overall satisfaction score at Month 3 was statistically greater than that at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
91558663|NCT04660799|183005866|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of Ctrough SC versus Ctrough IV.|Ratio Ctrough SC/Ctrough IV|1.52|||||TWO_SIDED|90.0|1.28|1.79||||||Geometric mean ratio of Ctrough SC/Ctrough IV and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.79|1.28|
91558664|NCT04660799|183005867|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of AUCsc versus AUCiv.|Geometric mean ratio of AUCsc/AUCiv|1.25|||||TWO_SIDED|90.0|1.1|1.42||||||Geometric mean ratio of AUCsc/AUCiv and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.42|1.10|
91558665|NCT04660799|183005872|SUPERIORITY||Difference in CRR|18.27|||||TWO_SIDED|95.0|-8.92|45.45||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||45.45|-8.92|
91558666|NCT04660799|183005873|SUPERIORITY||Difference in ORR Investigator|17.63|||||TWO_SIDED|95.0|-6.86|42.11||||||Investigator; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||42.11|-6.86|
91558667|NCT04660799|183005873|SUPERIORITY||Difference in ORR IRC|14.1|||||TWO_SIDED|95.0|-12.68|40.88||||||IRC; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||40.88|-12.68|
91558668|NCT04660799|183005874|SUPERIORITY||Difference in CRR|7.05|||||TWO_SIDED|95.0|-22.49|36.59||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||36.59|-22.49|
91558669|NCT04660799|183005875|SUPERIORITY||Difference in CRR|18.59|||||TWO_SIDED|95.0|-9.55|46.73||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||46.73|-9.55|
91558670|NCT02356198|183005925|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91558671|NCT02356198|183005926|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
91558672|NCT02356198|183005927|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
91558673|NCT02356198|183005928|SUPERIORITY|||||||0.454|||||||Chi-squared|||||||0.454
91558674|NCT02356198|183005929|SUPERIORITY|||||||0.212|||||||Fisher Exact|||||||0.212
91558675|NCT02397707|183005948|OTHER||Geometric Least-Square Mean (GLSM)Ratio%|411.62|||||TWO_SIDED|90.0|214.72|789.08||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||789.08|214.72|
91558676|NCT02397707|183005948|OTHER||GLSM Ratio (%)|644.15|||||TWO_SIDED|90.0|364.67|1137.82||||||An ANOVA appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1137.82|364.67|
91558677|NCT02397707|183005949|OTHER||GLSM Ratio (%)|399.24|||||TWO_SIDED|90.0|210.89|755.81||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||755.81|210.89|
91558678|NCT02397707|183005949|OTHER||GLSM Ratio (%)|599.63|||||TWO_SIDED|90.0|342.36|1050.22||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||1050.22|342.36|
91558679|NCT02397707|183005950|OTHER||GLSM Ratio (%)|338.41|||||TWO_SIDED|90.0|168.96|677.79||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||677.79|168.96|
91558680|NCT02397707|183005950|OTHER||GLSM Ratio (%)|713.92|||||TWO_SIDED|90.0|384.07|1327.06||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1327.06|384.07|
91558681|NCT03212638|183005961|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|1.04|||||TWO_SIDED|95.0|0.946|1.15||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.15|0.946|
91558682|NCT03212638|183005961|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|1.04|||||TWO_SIDED|95.0|0.944|1.14||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.14|0.944|
91558683|NCT03212638|183005961|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.675|||||TWO_SIDED|95.0|0.617|0.74||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||0.740|0.617|
91558684|NCT03212638|183005962|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.996|||||TWO_SIDED|95.0|0.963|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.963|
91558685|NCT03212638|183005962|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.998|||||TWO_SIDED|95.0|0.995|1.03||||||Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.03|0.995|
91558686|NCT03212638|183005962|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.973|||||TWO_SIDED|95.0|0.936|1.01||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.01|0.936|
91558687|NCT03212638|183005963|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.996|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.996|
91558688|NCT03212638|183005963|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.966|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.966|
91558689|NCT03212638|183005963|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.978|||||TWO_SIDED|95.0|0.941|1.02||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.02|0.941|
91558690|NCT03787628|183005977|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.703||||0.41|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of cue-induced craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on the measure of cue-induced craving (degrees of freedom = 1, 67).|||||0.41
91558691|NCT03787628|183005978|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.0||||0.99|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of spontaneous craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on spontaneous craving (degrees of freedom = 1, 550).|||||0.99
91558692|NCT03787628|183005979|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.04||||0.84|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of state anxiety.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on state anxiety (degrees of freedom = 1, 550)|||||0.84
91558693|NCT03787628|183005980|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.27||||0.6|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of negative affect.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on negative affect (degrees of freedom = 1, 550).|||||0.60
91558694|NCT02334215|183005984|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||.32
91558695|NCT02334215|183005984|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.32
91558696|NCT02334215|183005985|SUPERIORITY|||||||0.001|||||||Generalized Linear Mixed Model Analysis|||Contrast of Interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual Conditions||||.001
91558697|NCT02334215|183005985|SUPERIORITY|||||||0.84|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||.84
91558698|NCT02334215|183005986|SUPERIORITY|||||||0.11|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual||||0.11
91558699|NCT02334215|183005986|SUPERIORITY|||||||0.55|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.55
91558700|NCT02334215|183005987|SUPERIORITY|||||||0.55|||||||Regression, Logistic|||||||0.55
91558701|NCT02334215|183005987|SUPERIORITY|||||||0.57|||||||Regression, Logistic|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.57
91558702|NCT02334215|183005988|SUPERIORITY|||||||0.997|||||||Generalized Linear Mixed Model|||Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||.997
91558703|NCT02334215|183005988|SUPERIORITY|||||||0.26|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.26
91558704|NCT02334215|183005989|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||||0.663|||||||Generalized Linear Mixed Model|||||||.663
91558705|NCT02334215|183005989|SUPERIORITY|||||||0.33|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.33
91558706|NCT02334215|183005990|SUPERIORITY|||||||0.007|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||0.007
91558707|NCT02334215|183005990|SUPERIORITY|||||||0.76|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.76
91558708|NCT02334215|183005991|SUPERIORITY|||||||0.6|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||0.60
91558709|NCT02334215|183005991|SUPERIORITY|||||||1|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||1.0
91558710|NCT02334215|183005992|SUPERIORITY|||||||0.09|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.09
91558711|NCT02334215|183005992|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
91558712|NCT02334215|183005993|SUPERIORITY|||||||0.013|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.013
91558713|NCT02334215|183005993|SUPERIORITY|||||||0.71|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.71
91558714|NCT02334215|183005994|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.32|||||||Generalized Linear Mixed Model Analysis|||||||.32
91558715|NCT02334215|183005994|SUPERIORITY|||||||0.85|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.85
91558716|NCT02334215|183005995|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.1|||||||Generalized Linear Mixed Model Analysis|||||||.10
91558717|NCT02334215|183005995|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
91558718|NCT02334215|183005996|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.42|||||||Generalized Linear Mixed Model Analysis|||||||.42
91558719|NCT02334215|183005996|SUPERIORITY|||||||0.42|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.42
91558720|NCT02334215|183005997|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.28|||||||Generalized Linear Mixed Model Analysis|||||||.28
91558721|NCT02334215|183005997|SUPERIORITY|||||||0.44|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.44
91558722|NCT02334215|183005998|SUPERIORITY|||||||0.61|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone combined vs. Enhanced Treatment as Usual||||.61
91558723|NCT02334215|183005998|SUPERIORITY|||||||0.72|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.72
91558724|NCT02334215|183005999|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.71|||||||Generalized Linear Mixed Model Analysis|||||||.71
91558725|NCT02334215|183005999|SUPERIORITY|||||||0.86|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.86
91558726|NCT02746107|183006034|NON_INFERIORITY_OR_EQUIVALENCE|details provided in the protocol. Noninferiority margin=+/-5%|Risk Difference (RD)|0.5||||0.83|TWO_SIDED|95.0|-4.0|5.4|||Chi-squared|||||5.4|-4|0.83
91558727|NCT02746107|183006035|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4||||0.187|TWO_SIDED|95.0|-1.3|8.1|||Chi-squared||(risk on 5y) - (risk on 1y)|details provided in protocol;||8.1|-1.3|0.187
91558728|NCT02746107|183006036|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.4|||<|0.001|TWO_SIDED|95.0|10.8|20.0|||Chi-squared||patient - (physicians themselves)|||20|10.8|<0.001
91558729|NCT02746107|183006036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28|||<|0.001|TWO_SIDED|95.0|2.25|4.78|||Regression, Logistic|adjustment for age, gender, CHA2D2s-VASC score, nr of diagrams, nr of years, presence of someone close with stroke, graduation year, speciality||||4.78|2.25|<0.001
91558730|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3||||0.034|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|CHA2D2S-VASC risk score 1 was reference|positive value means higher proportion of prescription, CHA2D2S-VASC risk score 1 was reference|CHA2D2S-VASC risk score 1 was the reference||17|1.2|0.034
91558731|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.033|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|||||17|1.2|0.033
91558732|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.003|TWO_SIDED|95.0|4.7|20.1|||Chi-squared|||||20.1|4.7|0.003
91558733|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.1||||0.009|TWO_SIDED|95.0|3.2|18.8|||Chi-squared|||||18.8|3.2|0.009
91558734|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.024|TWO_SIDED|95.0|1.08|3.07|||Regression, Logistic|CHA2D2S-VASC risk score 1 was the reference, adjusted for nr diagrams, nr years, age, gender, smb close with stroke, speciality, professional degree||CHA2D2S-VASC risk score 1 was the reference||3.07|1.08|0.024
91558735|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.03|TWO_SIDED|95.0|1.06|2.98|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator: CHADS-VASC 1|||2.98|1.06|0.03
91558736|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.002|TWO_SIDED|95.0|1.37|4.09|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator = CHADS-VASC 1|||4.09|1.37|0.002
91558737|NCT02746107|183006037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.004|TWO_SIDED|95.0|1.14|2.56|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator=CHADS-VASC 1|||2.56|1.14|0.004
91558738|NCT01450007|183006038|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
91558739|NCT01450007|183006039|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
91558740|NCT01450007|183006040|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
91558741|NCT01450007|183006041|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 24 hours.||||0.61
91558742|NCT01450007|183006041|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 48 hours.||||0.13
91558743|NCT01450007|183006041|SUPERIORITY_OR_OTHER|||||||0.25|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 1 week.||||0.25
91558744|NCT01536704|183006069|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.88|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.88|
91558745|NCT01536704|183006069|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05|||Wilcoxon Signed Rank test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.05|0.98|
91558746|NCT01536704|183006070|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.85|
91558747|NCT01536704|183006070|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.02|0.93|
91558748|NCT01536704|183006071|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.92||||||90.0|0.88|0.95|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.95|0.88|
91558749|NCT01536704|183006071|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.06|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.06|0.98|
91558750|NCT01536704|183006072|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0006||||0.1491||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.1491
91558751|NCT01536704|183006072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0005||||0.679||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.6790
91558752|NCT01536704|183006073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0641||||0.5619||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5619
91558753|NCT01536704|183006073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0538||||0.4523||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.4523
91558754|NCT01536704|183006074|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0025||||0.5113||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5113
91558755|NCT01536704|183006074|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.0042||||0.537||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5370
91558756|NCT04658784|183006075|SUPERIORITY||Odds Ratio (OR)|0.51||||0.32|TWO_SIDED|95.0|0.13|1.92||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||1.92|0.13|0.32
91558757|NCT04658784|183006076|SUPERIORITY||Odds Ratio (OR)|0.48||||1|TWO_SIDED|95.0|0.04|5.65||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||5.65|0.04|1.0
91558758|NCT04658784|183006079|SUPERIORITY||Mean Difference (Net)|2.6||||1|TWO_SIDED|95.0|-3.5|8.7||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6- weeks.||8.7|-3.5|1.0
91558759|NCT04658784|183006079|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-5.6|3.2||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6-months.||3.2|-5.6|
91558760|NCT04658784|183006080|SUPERIORITY||Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-6.6|6.9||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-weeks.||6.9|-6.6|1.0
91558761|NCT04658784|183006080|SUPERIORITY|Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-months.|Mean Difference (Net)|2.8||||1|TWO_SIDED|95.0|-3.1|8.6||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||||8.6|-3.1|1
91558762|NCT04658784|183006081|SUPERIORITY||Mean Difference (Net)|-1.6||||1|TWO_SIDED|95.0|-4.4|1.3||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6 months.||1.3|-4.4|1.0
91768626|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|23.3||||0.078|TWO_SIDED|95.0|-1.9|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.5|-1.9|0.078
91768627|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|10.3||||0.466|TWO_SIDED|95.0|-17.7|38.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||38.4|-17.7|0.466
91558763|NCT00704340|183006114|SUPERIORITY_OR_OTHER|||||||0.613|||||||t-test, 2 sided|||The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.||||.613
91558764|NCT00704340|183006115|SUPERIORITY_OR_OTHER|||||||0.681|||||||t-test, 2 sided|||||||.681
91558765|NCT00704340|183006116|SUPERIORITY_OR_OTHER|||||||0.619|||||||t-test, 2 sided|||||||.619
91558766|NCT03316170|183006158|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.44||0.06|TWO_SIDED|95.0|-1.75|0.3|||t-test, 2 sided|||||0.30|-1.75|.06
91558767|NCT02935673|183006165|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.32|||||TWO_SIDED|95.0|-0.89|0.24|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.24|-0.89|
91558768|NCT02935673|183006165|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.36|||||TWO_SIDED|95.0|-1.33|0.62|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.62|-1.33|
91558769|NCT01836523|183006200|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.2|||||TWO_SIDED|95.0|-0.32|-0.07||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.07|-0.32|
91558770|NCT01836523|183006200|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.15|||||TWO_SIDED|95.0|-0.27|-0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.03|-0.27|
91558771|NCT01836523|183006200|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.09|||||TWO_SIDED|95.0|-0.21|0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||0.03|-0.21|
91558772|NCT01836523|183006201|SUPERIORITY_OR_OTHER||Treatment difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-5.65|-4.16|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-4.16|-5.65|<0.0001
91558773|NCT01836523|183006201|SUPERIORITY_OR_OTHER||Treatment difference|-3.55|||<|0.0001|TWO_SIDED|95.0|-4.29|-2.81|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-2.81|-4.29|<0.0001
91558774|NCT01836523|183006201|SUPERIORITY_OR_OTHER||Treatment difference|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.91|-1.47|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-1.47|-2.91|<0.0001
91558775|NCT01836523|183006202|SUPERIORITY_OR_OTHER||Treatment ratio|0.92|||<|0.0001|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.96|0.88|<0.0001
91558776|NCT01836523|183006202|SUPERIORITY_OR_OTHER||Treatment ratio|0.95||||0.0148|TWO_SIDED|95.0|0.91|0.99|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.99|0.91|0.0148
91558777|NCT01836523|183006202|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.9615|TWO_SIDED|95.0|0.96|1.04|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||1.04|0.96|0.9615
91558778|NCT01836523|183006203|SUPERIORITY_OR_OTHER||Rate ratio|1.31||||0.0081|TWO_SIDED|95.0|1.07|1.59|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.59|1.07|0.0081
91558779|NCT01836523|183006203|SUPERIORITY_OR_OTHER||Rate ratio|1.27||||0.0219|TWO_SIDED|95.0|1.03|1.55|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.55|1.03|0.0219
91558780|NCT01836523|183006203|SUPERIORITY_OR_OTHER||Rate ratio|1.17||||0.1079|TWO_SIDED|95.0|0.97|1.43|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.43|0.97|0.1079
91558781|NCT02037568|183006204|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||.96
91558782|NCT02037568|183006205|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
91558783|NCT02037568|183006206|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
91558784|NCT02037568|183006207|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
91558785|NCT02037568|183006208|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.070
91558786|NCT02037568|183006209|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
91558787|NCT02037568|183006210|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
91558788|NCT02037568|183006211|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
91558789|NCT02037568|183006212|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
91558790|NCT00380250|183006213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|||||||van Elteren nonparametric test|Adjusted for center||||||0.117
91558791|NCT00380250|183006214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||van Elteren nonparametric test|Adjusted for center||||||0.006
91558792|NCT00380250|183006215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||van Elteren nonparametric test|Adjusted for center||||||0.050
91558793|NCT00380250|183006216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159|||||||van Elteren nonparametric test|Adjusted for center||||||0.159
91558794|NCT00380250|183006217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.378
91558795|NCT00380250|183006218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588|||||||ANCOVA|Adjusted for clinical site||||||0.588
91558796|NCT00380250|183006219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||90% statistical power to detect 70.6% improvement in response with lubiprostone||||0.029
91558797|NCT00380250|183006220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.028
91558798|NCT00380250|183006221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.069
91558799|NCT00380250|183006222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.098
91558800|NCT00380250|183006223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286|||||||van Elteren nonparametric test|Adjusted for center||||||0.286
91558801|NCT00380250|183006224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.337|||||||van Elteren nonparametric test|Adjusted for center||||||0.337
91558802|NCT00380250|183006225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||van Elteren nonparametric test|Adjusted for center||||||0.334
91558803|NCT00380250|183006226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||van Elteren nonparametric test|Adjusted for center||||||0.242
91558804|NCT00380250|183006227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||van Elteren nonparametric test|Adjusted for center||||||0.030
91558805|NCT00380250|183006228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||van Elteren nonparametric test|Adjusted for center||||||0.130
91558806|NCT00380250|183006229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||van Elteren nonparametric test|Adjusted for center||||||0.049
91558807|NCT00380250|183006230|SUPERIORITY_OR_OTHER_LEGACY|||||||0.348|||||||van Elteren nonparametric test|Adjusted for center||||||0.348
91558808|NCT00380250|183006231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||van Elteren nonparametric test|Adjusted for center||||||0.064
91558809|NCT00380250|183006232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111|||||||van Elteren nonparametric test|||||||0.111
91558810|NCT00380250|183006233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.144
91558811|NCT00380250|183006234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||Cochran-Mantel-Haenszel|Adjusted by pooled center||||||0.168
91558812|NCT00380250|183006235|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|||||||van Elteren nonparametic test|Adjusted for center||||||0.615
91558813|NCT00380250|183006236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108|||||||van Elteren nonparametric test|||||||0.108
91558814|NCT00380250|183006237|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||van Elteren nonparametric test|||||||0.483
91558815|NCT00380250|183006238|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491|||||||van Elteren nonparametric test|||||||0.491
91558816|NCT00380250|183006239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
91558817|NCT00380250|183006240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
91558818|NCT00380250|183006241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
91558819|NCT03652610|183006256|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratio for serogroup A is \> 0.5|GMT ratio|0.88|||||TWO_SIDED|95.0|0.64|1.2|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.20|0.64|
91558820|NCT03652610|183006257|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.84|1.68|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 29||1.68|0.84|
91558821|NCT03652610|183006257|OTHER||GMT ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 29||1.58|0.96|
91558822|NCT03652610|183006257|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.9|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 29||1.58|0.90|
91558823|NCT03652610|183006259|OTHER||Difference in percentage of subjects|-3.87|||||TWO_SIDED|95.0|-9.3|1.52|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||1.52|-9.30|
91558824|NCT03652610|183006259|OTHER||Difference in percentage of subjects|1.87|||||TWO_SIDED|95.0|-4.7|8.43|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||8.43|-4.70|
91558825|NCT03652610|183006259|OTHER||Difference in percentage of subjects|4.54|||||TWO_SIDED|95.0|-1.97|11.01|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||11.01|-1.97|
91558826|NCT03652610|183006259|OTHER||Difference in percentage of subjects|5.25|||||TWO_SIDED|95.0|-1.11|11.57|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||11.57|-1.11|
91558827|NCT03652610|183006260|OTHER||Difference in percentage of subjects|-2.47|||||TWO_SIDED|95.0|-6.47|1.49|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 1||1.49|-6.47|
91558828|NCT03652610|183006260|OTHER||Difference in percentage of subjects|-0.58|||||TWO_SIDED|95.0|-6.99|5.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 1||5.83|-6.99|
91558829|NCT03652610|183006260|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.33|0.47|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 1||0.47|-12.33|
91558830|NCT03652610|183006260|OTHER||Difference in percentage of subjects|-2.78|||||TWO_SIDED|95.0|-8.3|2.76|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 1||2.76|-8.30|
91558831|NCT03652610|183006260|OTHER||Difference in percentage of subjects|-3.69|||||TWO_SIDED|95.0|-8.65|1.21|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 29||1.21|-8.65|
91558832|NCT03652610|183006260|OTHER||Difference in percentage of subjects|-0.4|||||TWO_SIDED|95.0|-6.12|5.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 29||5.33|-6.12|
91558833|NCT03652610|183006260|OTHER||Difference in percentage of subjects|0.26|||||TWO_SIDED|95.0|-5.49|6.02|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 29||6.02|-5.49|
91558834|NCT03652610|183006260|OTHER||Difference in percentage of subjects|1.15|||||TWO_SIDED|95.0|-4.33|6.62|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 29||6.62|-4.33|
91558835|NCT03652610|183006261|OTHER||Difference in percentage of subjects|-2.91|||||TWO_SIDED|95.0|-7.24|1.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||1.37|-7.24|
91558836|NCT03652610|183006261|OTHER||Difference in percentage of subjects|-1.09|||||TWO_SIDED|95.0|-7.34|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||5.16|-7.34|
91558837|NCT03652610|183006261|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.35|0.5|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||0.50|-12.35|
91558838|NCT03652610|183006261|OTHER||Difference in percentage of subjects|-2.55|||||TWO_SIDED|95.0|-8.15|3.06|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||3.06|-8.15|
91558839|NCT03652610|183006261|OTHER||Difference in percentage of subjects|-3.92|||||TWO_SIDED|95.0|-8.87|0.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||0.96|-8.87|
91558840|NCT03652610|183006261|OTHER||Difference in percentage of subjects|0.07|||||TWO_SIDED|95.0|-5.52|5.65|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.65|-5.52|
91558841|NCT03652610|183006261|OTHER||Difference in percentage of subjects|-0.17|||||TWO_SIDED|95.0|-5.92|5.57|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||5.57|-5.92|
91558842|NCT03652610|183006261|OTHER||Difference in percentage of subjects|0.5|||||TWO_SIDED|95.0|-4.89|5.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.90|-4.89|
91558843|NCT01450397|183006267|SUPERIORITY_OR_OTHER||||||<|0.0013|||||||t-test, 2 sided|||||||<0.0013
91558844|NCT04278833|183006279|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
91768628|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
91558845|NCT04278833|183006279|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||<0.001
91558846|NCT04278833|183006279|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||<0.001
91558847|NCT04278833|183006280|OTHER|||||||0.28||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at week 2||||0.280
91558848|NCT04278833|183006280|OTHER|||||||0.07||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 3||||0.070
91558849|NCT04278833|183006280|OTHER|||||||0.851||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 6||||0.851
91558850|NCT04278833|183006281|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
91558851|NCT04278833|183006281|OTHER|||||||0.021||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.021
91558852|NCT04278833|183006281|OTHER|||||||0.044||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.044
91558853|NCT04278833|183006282|OTHER|||||||0.226||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.226
91558854|NCT04278833|183006282|OTHER|||||||0.071||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.071
91768629|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|0.447
91558855|NCT04278833|183006282|OTHER|||||||0.382||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.382
91558856|NCT04278833|183006283|OTHER|||||||0.152||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.152
91558857|NCT04278833|183006283|OTHER|||||||0.261||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3.||||0.261
91558858|NCT04278833|183006283|OTHER|||||||0.437||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6.||||0.437
91558859|NCT04278833|183006284|OTHER|||||||0.128||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.128
91558860|NCT04278833|183006284|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
91558861|NCT04278833|183006285|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.040
91558862|NCT04278833|183006285|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
91558863|NCT05200416|183006299|SUPERIORITY||Mean Difference (Final Values)|11.42|||<|0.001|TWO_SIDED|95.0|7.83|15.01|||Mixed Models Analysis|||||15.01|7.83|<0.001
91558864|NCT05200416|183006300|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.001|TWO_SIDED|95.0|-6.69|-1.63|||Mixed Models Analysis|||||-1.63|-6.69|0.001
91558865|NCT02485925|183006301|OTHER||Proportion of participants|80.7|||||TWO_SIDED|95.0|73.9|86.4|||||||95% confidence interval is based on Clopper-Pearson confidence interval|86.4|73.9|
91558866|NCT02485925|183006302|OTHER||Proportion of participants|99.5|||||TWO_SIDED|95.0|97.2|100.0|||||||95% confidence interval is based on Clopper-Pearson confidence interval|100.0|97.2|
91558867|NCT04181788|183006311|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|231.2|||||TWO_SIDED|90.0|190.09|281.21||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||281.21|190.09|
91558868|NCT04181788|183006312|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|111.48|||||TWO_SIDED|90.0|86.31|143.99||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||143.99|86.31|
91558869|NCT06922643|183006343|OTHER||Odds Ratio (OR)|6.73||||0.008|TWO_SIDED|95.0|1.63|27.8|||Regression, Logistic|||||27.8|1.63|0.008
91558870|NCT06943638|183006358|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91558871|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.72|||||TWO_SIDED|95.0|-0.33|1.77||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.77|-0.33|
91558872|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.46|||||TWO_SIDED|95.0|-0.5|1.43||||||Period AC: Difference varenicline versus placebo.||1.43|-0.50|
91558873|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.92|||||TWO_SIDED|95.0|-0.27|2.11||||||Period AD: Difference varenicline versus placebo.||2.11|-0.27|
91558874|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.52|1.53||||||Period AE: Difference varenicline versus placebo.||1.53|-0.52|
91558875|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.35|0.5|||||Mixed Models Analysis|Period BC: Difference varenicline versus placebo.||0.50|-1.35|
91558876|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-1.18|1.24||||||Period BD: Difference varenicline versus placebo.||1.24|-1.18|
91558877|NCT00749944|183006409|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.37|||||TWO_SIDED|95.0|-1.37|0.63|||||Mixed Models Analysis|Period BE: Difference varenicline versus placebo.||0.63|-1.37|
91558878|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|-0.15|1.39||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.39|-0.15|
91558879|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-0.24|1.07||||||Period AC: Difference varenicline versus placebo.||1.07|-0.24|
91558880|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.26|1.22||||||Period AD: Difference varenicline versus placebo.||1.22|-0.26|
91558881|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.18|1.06||||||Period AE: Difference varenicline versus placebo.||1.06|-0.18|
91558882|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.58|0.78||||||Period BC: Difference varenicline versus placebo.||0.78|-0.58|
91558883|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.48|0.92||||||Period BD: Difference varenicline versus placebo.||0.92|-0.48|
91558884|NCT00749944|183006410|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.26|0.72||||||Period BE: Difference varenicline versus placebo.||0.72|-0.26|
91558885|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|0.0|1.24||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.24|-0.00|
91558886|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.73|||||TWO_SIDED|95.0|0.18|1.29||||||Period AC: Difference varenicline versus placebo.||1.29|0.18|
91558887|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.66|||||TWO_SIDED|95.0|0.02|1.3||||||Period AD: Difference varenicline versus placebo.||1.30|0.02|
91558888|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.43|||||TWO_SIDED|95.0|-0.19|1.05||||||Period AE: Difference varenicline versus placebo.||1.05|-0.19|
91558889|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.09|1.05||||||Period BC: Difference varenicline versus placebo.||1.05|-0.09|
91558890|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.39|||||TWO_SIDED|95.0|-0.28|1.06||||||Period BD: Difference varenicline versus placebo.||1.06|-0.28|
91558891|NCT00749944|183006411|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.47|0.65||||||Period BE: Difference varenicline versus placebo.||0.65|-0.47|
91558892|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|-0.02|1.72|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.72|-0.02|
91558893|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|0.16|1.54|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.54|0.16|
91558894|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.24|||||TWO_SIDED|95.0|0.39|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||2.08|0.39|
91558895|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.83|||||TWO_SIDED|95.0|0.14|1.52|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.52|0.14|
91558896|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.06|1.09|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.09|-0.06|
91558897|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.88|||||TWO_SIDED|95.0|0.05|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||1.70|0.05|
91558898|NCT00749944|183006412|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.38|||||TWO_SIDED|95.0|-0.12|0.88|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.88|-0.12|
91558899|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.82|||||TWO_SIDED|95.0|-3.07|1.43|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.43|-3.07|
91558900|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-2.47|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||2.08|-2.47|
91558901|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-2.15|||||TWO_SIDED|95.0|-5.19|0.89|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.89|-5.19|
91558902|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.98|||||TWO_SIDED|95.0|-3.67|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.70|-3.67|
91558903|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.95|||||TWO_SIDED|95.0|-0.36|4.26|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||4.26|-0.36|
91558904|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-3.32|3.3|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||3.30|-3.32|
91558905|NCT00749944|183006413|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.09|||||TWO_SIDED|95.0|-1.8|3.97|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||3.97|-1.80|
91558906|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.29|1.32|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.32|-0.29|
91768630|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
91768631|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-11.8||||1|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|1.000
91768632|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-11.8||||0.193|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.193
91558907|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.54|||||TWO_SIDED|95.0|-0.17|1.25|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.25|-0.17|
91558908|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.18|||||TWO_SIDED|95.0|-0.55|0.92|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.92|-0.55|
91768633|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-11.8||||0.498|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.498
91558909|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.26|||||TWO_SIDED|95.0|-0.46|0.99|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.99|-0.46|
91558910|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.59|||||TWO_SIDED|95.0|-0.19|1.37|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.37|-0.19|
91558911|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.76|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.76|-0.91|
91558912|NCT00749944|183006414|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.65|0.85|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.85|-0.65|
91558913|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.2|0.65|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.65|-0.20|
91558914|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.17|0.58|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||0.58|-0.17|
91768634|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
91558915|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.23|0.65|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.65|-0.23|
91558916|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.37|0.41|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.41|-0.37|
91558917|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.41|0.59|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||0.59|-0.41|
91558918|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.63|-0.44|
91558919|NCT00749944|183006415|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.12|||||TWO_SIDED|95.0|-0.58|0.34|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.34|-0.58|
91558920|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.66|1.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.10|-0.66|
91558921|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.46|1.35|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.35|-0.46|
91558922|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.22|||||TWO_SIDED|95.0|-1.16|0.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.71|-1.16|
91558923|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.68|0.73|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.73|-0.68|
91558924|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.58|||||TWO_SIDED|95.0|-0.79|1.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.96|-0.79|
91558925|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.69|0.82|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.82|-1.69|
91558926|NCT00749944|183006416|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.09|||||TWO_SIDED|95.0|-0.86|0.68|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.68|-0.86|
91558927|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.27|||||TWO_SIDED|95.0|-0.55|1.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.08|-0.55|
91768635|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|0.447
91558928|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.53|||||TWO_SIDED|95.0|-0.39|1.46|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.46|-0.39|
91558929|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-1.08|1.25|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||1.25|-1.08|
91558930|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.14|||||TWO_SIDED|95.0|-0.62|0.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.90|-0.62|
91558931|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.94|1.95|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.95|-0.94|
91558932|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-1.57|1.51|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.51|-1.57|
91558933|NCT00749944|183006417|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.75|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.75|-0.91|
91558934|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.35|||||TWO_SIDED|95.0|-1.76|1.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.06|-1.76|
91558935|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.11|||||TWO_SIDED|95.0|-0.96|1.17|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.17|-0.96|
91558936|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.49|||||TWO_SIDED|95.0|-1.94|4.91|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||4.91|-1.94|
91558937|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-1.18|2.18|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.18|-1.18|
91558938|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.61|||||TWO_SIDED|95.0|-0.85|2.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||2.07|-0.85|
91558939|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|2.1|||||TWO_SIDED|95.0|-2.6|6.79|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||6.79|-2.60|
91558940|NCT00749944|183006418|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.13|||||TWO_SIDED|95.0|-0.7|2.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||2.96|-0.70|
91558941|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.26|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.27|-0.26|
91558942|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.25|0.29|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.29|-0.25|
91558943|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.37|0.58|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.58|-0.37|
91768636|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
91768637|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
91768638|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|0.447
91558944|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.17|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.34|-0.17|
91768639|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
91768640|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
91768641|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-1.1||||1|TWO_SIDED|95.0|-15.5|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.3|-15.5|1.000
91558945|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.04|||||TWO_SIDED|95.0|-0.4|0.48|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.48|-0.40|
91558946|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.17|||||TWO_SIDED|95.0|-0.44|0.78|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.78|-0.44|
91558947|NCT00749944|183006419|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.13|||||TWO_SIDED|95.0|-0.14|0.4|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.40|-0.14|
91768642|NCT02365649|183425715|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
91768643|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-57.2|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||43.9|-57.2|1.000
91558948|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-1.09|1.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.90|-1.09|
91558949|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-1.54|1.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.71|-1.54|
91558950|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|-2.47|2.6|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||2.60|-2.47|
91558951|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.29|||||TWO_SIDED|95.0|-1.57|2.15|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.15|-1.57|
91558952|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.94|||||TWO_SIDED|95.0|-2.23|0.36|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.36|-2.23|
91558953|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.74|||||TWO_SIDED|95.0|-2.81|1.33|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.33|-2.81|
91558954|NCT00749944|183006422|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.78|0.92|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.92|-1.78|
91768644|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||55.8|-9.2|0.323
91768645|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|33.3||||0.516|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||60.0|6.7|0.516
91558955|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.19|-0.04|
91558956|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.11|
91768646|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-31.7||||0.191|TWO_SIDED|95.0|-77.4|14.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||14.0|-77.4|0.191
91768647|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-26.0|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||22.6|-26.0|1.000
91768648|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||24.0|-7.3|1.000
91558957|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.06|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.09|-0.06|
91558958|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.02|-0.11|
91558959|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.14|||||TWO_SIDED|95.0|-0.27|-0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.01|-0.27|
91558960|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.21|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.01|-0.21|
91558961|NCT00749944|183006423|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.17|-0.03|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||-0.03|-0.17|
91558962|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.03|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.12|-0.03|
91558963|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.09|-0.08|
91558964|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.04|0.11|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.11|-0.04|
91558965|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.08|0.05|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.05|-0.08|
91558966|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.22|0.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.06|-0.22|
91558967|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-0.14|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.09|-0.14|
91558968|NCT00749944|183006424|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.11|
91558969|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.09|-0.20|
91558970|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.12|-0.15|
91558971|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.15|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.04|-0.15|
91558972|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.2|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.20|
91558973|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.17|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.27|-0.17|
91768649|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|33.3||||0.261|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||60.0|6.7|0.261
91768650|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||55.8|-9.2|0.323
91558974|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.21|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.21|
91558975|NCT00749944|183006425|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.07|-0.17|
91558976|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.3|||||TWO_SIDED|95.0|-0.58|-0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||-0.02|-0.58|
91558977|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.44|||||TWO_SIDED|95.0|-0.69|-0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||-0.19|-0.69|
91558978|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.14|||||TWO_SIDED|95.0|-0.47|0.2|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.20|-0.47|
91558979|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.35|||||TWO_SIDED|95.0|-0.61|-0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||-0.09|-0.61|
91558980|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.45|||||TWO_SIDED|95.0|-0.83|-0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.07|-0.83|
91558981|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.08|||||TWO_SIDED|95.0|-0.5|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.34|-0.50|
91558982|NCT00749944|183006426|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.27|||||TWO_SIDED|95.0|-0.57|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.57|
91558983|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.08|-0.12|
91558984|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.12|
91558985|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.14|-0.04|
91558986|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.07|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.07|
91558987|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.15|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.13|-0.15|
91558988|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|0.01|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|0.01|
91558989|NCT00749944|183006427|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.04|-0.08|
91558990|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.12|||||TWO_SIDED|95.0|-0.05|0.28|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.28|-0.05|
91558991|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.19|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.14|-0.19|
91558992|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.29|0.22|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.22|-0.29|
91558993|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.2|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.13|-0.20|
91558994|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-0.4|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.01|-0.40|
91558995|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.16|||||TWO_SIDED|95.0|-0.42|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.42|
91558996|NCT00749944|183006428|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.07|||||TWO_SIDED|95.0|-0.22|8.0|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||008|-0.22|
91558997|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.6|3.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.3|0.6|
91558998|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
91558999|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.1|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.1|0.4|
91559000|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
91559001|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
91559002|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
91559003|NCT00749944|183006429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
91559004|NCT00749944|183006430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.6|10.4|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||10.4|0.6|
91768651|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||58.5|-41.8|1.000
91559005|NCT00749944|183006430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.7|11.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||11.8|0.7|
91559006|NCT00749944|183006430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
91559007|NCT00749944|183006430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.4|7.8|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||7.8|0.4|
91559008|NCT00749944|183006430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.5|9.2|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||9.2|0.5|
91559009|NCT00749944|183006430|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.4|3.2|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.2|0.4|
91559010|NCT00749944|183006431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
91559011|NCT00749944|183006431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|0.7|5.3|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.7|
91559012|NCT00749944|183006431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.7|4.4|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.4|0.7|
91559013|NCT00749944|183006431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|5.0|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.0|0.5|
91559014|NCT00749944|183006431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|0.8|6.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||6.8|0.8|
91559015|NCT00749944|183006431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.8|5.3|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.8|
91559016|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|4.9|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.9|0.5|
91768652|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-26.7||||0.593|TWO_SIDED|95.0|-77.2|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||23.9|-77.2|0.593
91559017|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.0|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.0|0.4|
91559018|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
91559019|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.4|
91559020|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.6|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.3|
91559021|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
91559022|NCT00749944|183006432|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
91559023|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.3|
91559024|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.9|0.4|
91559025|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
91559026|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.5|2.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.6|0.5|
91768653|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.8|-9.2|0.323
91559027|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.3|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.5|
91559028|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.6|2.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.7|0.6|
91559029|NCT00749944|183006433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.5|2.8|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.8|0.5|
91559030|NCT00749944|183006435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
91559031|NCT00749944|183006435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
91559032|NCT00749944|183006435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.6|0.3|
91559033|NCT00749944|183006435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
91559034|NCT00749944|183006435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
91559035|NCT00749944|183006435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.7|0.3|
91559036|NCT00749944|183006436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.2|23.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||23.6|0.2|
91559037|NCT03265132|183006461|SUPERIORITY||Risk Difference (RD)|1.0||||0.0022|TWO_SIDED|95.0|0.42|1.0|||Fisher Exact|||||1.00|0.42|0.0022
91559038|NCT00089791|183006543|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.32|||<|0.0001||95.0|0.26|0.41||Logistic regression was used to generate the p-value|Mantel Haenszel|||||0.41|0.26|<0.0001
91559039|NCT00089791|183006544|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0106||95.0|0.67|0.95|||Regression, Cox|||||0.95|0.67|0.0106
91559040|NCT00089791|183006545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.0362||95.0|0.37|0.97|||Regression, Cox|||||0.97|0.37|0.0362
91559041|NCT02362789|183006557|SUPERIORITY||Mean Difference (Net)|-18.3||||0.0055|TWO_SIDED|95.0|-31.01|-5.59|||ANCOVA|||||-5.59|-31.01|0.0055
91559042|NCT00721734|183006560|SUPERIORITY_OR_OTHER||Slope|-0.607||||0.4114|TWO_SIDED|95.0|-2.129|0.914|||Regression, Linear|||"In order to estimate a possible effect of renal function, the relationship between the clearance of carfilzomib and creatinine clearance (CrCl) was explored using a mixed-effects model that included CrCl.~The slope of the regression of CL as a function of CrCL at Cycle 1, Day 1 was evaluated using a linear regression model that included CrCL as continuous variables (excluding the hemodialysis group)."||0.914|-2.129|0.4114
91559043|NCT05074433|183006591|SUPERIORITY||Hazard Ratio (HR)|0.563|||||TWO_SIDED|95.0|0.093|3.393|||Cox proportional hazard model|||||3.393|0.093|
91559044|NCT05074433|183006591|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.072|2.929|||Cox proportional hazard model|||||2.929|0.072|
91559045|NCT05074433|183006591|SUPERIORITY||Cox Proportional Hazard|0.609|||||TWO_SIDED|95.0|0.101|3.668|||Cox proportional hazard model|||||3.668|0.101|
91559046|NCT04492475|183006638|SUPERIORITY||Cox Proportional Hazard|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13|||Log Rank|||||1.13|0.87|0.880
91559047|NCT04492475|183006655|SUPERIORITY||Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|0.9|13.4||||||||13.4|0.9|
91559048|NCT04492475|183006655|SUPERIORITY||Risk Difference (RD)|23.6|||||TWO_SIDED|95.0|0.0|43.9||||||||43.9|0.0|
91559049|NCT04492475|183006656|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||||6.0|-3.2|
91559050|NCT04492475|183006656|SUPERIORITY||Risk Difference (RD)|35.8|||||TWO_SIDED|95.0|12.3|54.2||||||||54.2|12.3|
91559051|NCT04492475|183006680|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
91559052|NCT04492475|183006680|SUPERIORITY||Cox Proportional Hazard|0.37|||||TWO_SIDED|95.0|0.21|0.66||||||||0.66|0.21|
91559053|NCT04492475|183006681|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
91559054|NCT04492475|183006681|SUPERIORITY||Cox Proportional Hazard|0.44|||||TWO_SIDED|95.0|0.24|0.82||||||||0.82|0.24|
91559055|NCT04492475|183006682|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.93|1.26||||||||1.26|0.93|
91559056|NCT04492475|183006682|SUPERIORITY||Cox Proportional Hazard|0.39|||||TWO_SIDED|95.0|0.21|0.72||||||||0.72|0.21|
91559057|NCT04492475|183006683|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
91559058|NCT04492475|183006684|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.59|1.45||||||This analysis is for Asian participants.||1.45|0.59|
91559059|NCT04492475|183006684|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.66|1.27||||||This analysis is for Black and African American participants.||1.27|0.66|
91559060|NCT04492475|183006684|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||This analysis is for White participants.||1.21|0.86|
91559061|NCT04492475|183006684|SUPERIORITY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.59|1.19||||||This analysis is for Race of Other participants||1.19|0.59|
91559062|NCT04492475|183006685|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.19||||||This analysis is for Not Hispanic or Latino participants.||1.19|0.86|
91559063|NCT04492475|183006685|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.65|1.05||||||This analysis is for Hispanic or Latino participants.||1.05|0.65|
91559064|NCT04492475|183006686|SUPERIORITY||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.78|1.1||||||This analysis is for Male participants.||1.10|0.78|
91559065|NCT04492475|183006686|SUPERIORITY||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||This analysis is for Female participants.||1.29|0.86|
91559066|NCT01235936|183006725|OTHER|The primary endpoint was compared using the Wilcoxon signed-rank test, with an alpha level of 0.05.||||||0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0020
91559067|NCT01235936|183006726|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0156|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0156
91559068|NCT01235936|183006727|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.||||||0.0098|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0098
91559069|NCT01235936|183006728|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0195|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0195
91559070|NCT01235936|183006729|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.8262|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.8262
91559071|NCT01235936|183006735|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0020
91559072|NCT01235936|183006736|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.2383|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.2383
91559073|NCT01235936|183006737|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
91559074|NCT01235936|183006738|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
91559075|NCT05270460|183006749|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level|ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
91559076|NCT05270460|183006750|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
91559077|NCT05270460|183006751|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91559078|NCT05270460|183006752|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91559079|NCT05270460|183006753|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91559080|NCT05270460|183006754|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91559081|NCT05270460|183006755|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91768654|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.5|-41.8|1.000
91559082|NCT05270460|183006756|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
91559083|NCT05270460|183006757|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91559084|NCT05270460|183006758|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
91559085|NCT02833948|183006760|SUPERIORITY|||||||0.01|||||||Fisher Exact|The Fisher's exact probability test was used to compare the percentages of patients with the primary end point between the treatment groups.||||||0.01
91559086|NCT02833948|183006764|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
91559087|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-63.09|60.57|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||60.57|-63.09|
91559088|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|-27.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-91.24|36.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||36.97|-91.24|
91559089|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|43.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|-32.19|119.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||119.62|-32.19|
91559090|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|61.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-6.38|129.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||129.35|-6.38|
91559091|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|125.87|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|60.51|191.23|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||191.23|60.51|
91559092|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|156.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|84.99|227.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||227.45|84.99|
91559093|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|51.42|STANDARD_ERROR_OF_MEAN|33.12|||TWO_SIDED|90.0|-3.57|106.41|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||106.41|-3.57|
91559094|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|142.74|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|82.76|202.72|||||Test (PF-05251749 200 mg PM) Reference (Placebo)|||202.72|82.76|
91559095|NCT02691702|183006807|OTHER|MMRM|Mean Difference (Final Values)|174.9|STANDARD_ERROR_OF_MEAN|36.01|||TWO_SIDED|90.0|115.11|234.69|||||Test (PF-05251749 500 mg PM) Reference (Placebo)|||234.69|115.11|
91768655|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|21.7||||0.6|TWO_SIDED|95.0|-23.1|66.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||66.5|-23.1|0.600
91768656|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|31.7||||0.162|TWO_SIDED|95.0|-1.9|65.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||65.2|-1.9|0.162
91559096|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|-71.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-133.09|-9.43|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||-9.43|-133.09|
91559097|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|-12.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-76.24|51.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||51.97|-76.24|
91559098|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|88.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|12.81|164.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||164.62|12.81|
91559099|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|46.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-21.38|114.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||114.35|-21.38|
91559100|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|87.3|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|21.94|152.66|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||152.66|21.94|
91559101|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|126.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|54.99|197.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||197.45|54.99|
91559102|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|92.36|STANDARD_ERROR_OF_MEAN|35.48|||TWO_SIDED|90.0|33.51|151.21|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||151.21|33.51|
91559103|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|107.29|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|47.31|167.27|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||167.27|47.31|
91559104|NCT02691702|183006808|OTHER|MMRM|Mean Difference (Final Values)|140.61|STANDARD_ERROR_OF_MEAN|37.79|||TWO_SIDED|90.0|77.91|203.3|||||Test (PF-05251749 500 mg AM) Reference (Placebo)|||203.30|77.91|
91559105|NCT05613088|183006821|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.4063|TWO_SIDED|95.0|0.76|2.0|||Log Rank|||||2.00|0.76|0.4063
91559106|NCT03205488|183006826|SUPERIORITY|||||||0.3626|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 150 group to the Placebo group.||||||0.3626
91559107|NCT03205488|183006826|SUPERIORITY|||||||0.3895|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 300 group to the Placebo group.||||||0.3895
91559108|NCT03205488|183006827|EQUIVALENCE|H0 : p1 = p2, where p represents the proportion of SAEs for each group. HA : p1 ≠ p2||||||1|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 150 group and the Placebo group.||||||1.00
91559109|NCT03205488|183006827|EQUIVALENCE|H0 : λ1 = λ2, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ2|Risk Ratio (RR)|0.4977||||0.5689|TWO_SIDED|95.0|0.0451|5.489|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 150 group and the placebo were also compared using a Poisson regression model||||5.489|0.0451|0.5689
91559110|NCT03205488|183006827|EQUIVALENCE|H0 : p1 = p3, where p represents the proportion of SAEs for each group. HA : p1 ≠ p3||||||0.61|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 300 group and the Placebo group.||||||0.61
91559111|NCT03205488|183006827|EQUIVALENCE|H0 : λ1 = λ3, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ3|Risk Ratio (RR)|0.5206||||0.594|TWO_SIDED|95.0|0.0472|5.7409|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 300 group and the placebo were also compared using a Poisson regression model||||5.7409|0.0472|0.5940
91559112|NCT03205488|183006828|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 150 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|1.05||||0.0001|ONE_SIDED|90.0|-0.78||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.78|0.0001
91559113|NCT03205488|183006828|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 300 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|0.93||||0.0001|ONE_SIDED|90.0|-0.89||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.89|0.0001
91559114|NCT03205488|183006828|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 1 month for the three treatment groups.||||||0.031|||||||Mixed Models Analysis|||Additional secondary objective #1 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 1 month.|In order to assess which group may be driving these findings, pairwise comparisons were also utilized (Nilotinib 150 vs PBO at 1 Month, Nilotinib 300 vs PBO at 1 month, Nilotinib 300 vs Nilotinib 150 at 1 month).|||0.031
91768657|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-34.1|67.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||67.4|-34.1|1.000
91559115|NCT03205488|183006828|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. For this analysis, a separate LMM was constructed, modeling the change from final visit on study drug to the 30 and 60 day follow up visits, while adjusting for the MDS-UPDRS Part III ON scores at the final visit on study drug as well as the Levodopa Equivalent Daily Dose (LEDD) at each visit.||||||0.47|||||||Mixed Models Analysis|||Additional secondary objective #2 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between the final visit on study drug and 30 days off study drug.||||0.47
91559116|NCT03205488|183006828|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.077|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 6 months.|Pairwise comparisons were also examined for trends (Active 150 vs PBO at 6 Months, Active 300 vs PBO at 6 months).|||0.077
91559117|NCT03205488|183006828|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using a similar LMM as in the key secondary analysis, except simplified to only include baseline, month 3 and month 6, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.17|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III OFF score between baseline and 6 months.||||0.17
91559118|NCT01742832|183006829|OTHER|Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.||||||0.342||||||P-value for linear regression assessing outcome measure (MADRS score) and treatment group.|Regression, Linear|||||||0.342
91559119|NCT05163353|183006830|SUPERIORITY||Difference in response rates|65.0|||||TWO_SIDED|95.0|45.6|74.4||||||||74.4|45.6|
91559120|NCT00824408|183006849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.045||||0.003|TWO_SIDED|95.0|1.271|3.292|||Log Rank|||Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||3.292|1.271|0.0030
91559121|NCT00824408|183006849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.141||||0.2804|TWO_SIDED|95.0|0.735|1.771|||Log Rank|||Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||1.771|0.735|0.2804
91559122|NCT00824408|183006850|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
91559123|NCT00824408|183006850|SUPERIORITY_OR_OTHER|||||||0.2596|||||||Fisher Exact|||||||0.2596
91559124|NCT00824408|183006851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.8406|TWO_SIDED|95.0|0.538|2.14|||Log Rank|||||2.140|0.538|0.8406
91559125|NCT00824408|183006851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.081||||0.396|TWO_SIDED|95.0|0.599|1.949|||Log Rank|||||1.949|0.599|0.3960
91559126|NCT01263496|183006873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|||||TWO_SIDED|95.0|-0.618|-0.184||||||||-0.184|-0.618|
91559127|NCT01263496|183006873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.548|||||TWO_SIDED|95.0|-0.739|-0.358||||||||-0.358|-0.739|
91559128|NCT01263496|183006873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-0.779|-0.401||||||||-0.401|-0.779|
91559129|NCT01263496|183006873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.708|||||TWO_SIDED|95.0|-0.894|-0.522||||||||-0.522|-0.894|
91559130|NCT01263496|183006874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-0.538|-0.093||||||||-0.093|-0.538|
91559131|NCT01263496|183006874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493|||||TWO_SIDED|95.0|-0.684|-0.302||||||||-0.302|-0.684|
91559132|NCT01263496|183006874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-0.706|-0.314||||||||-0.314|-0.706|
91559133|NCT01263496|183006874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|||||TWO_SIDED|95.0|-0.834|-0.461||||||||-0.461|-0.834|
91559134|NCT01263496|183006875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||||TWO_SIDED|95.0|-0.479|-0.047||||||||-0.047|-0.479|
91559135|NCT01263496|183006875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|||||TWO_SIDED|95.0|-0.598|-0.192||||||||-0.192|-0.598|
91559136|NCT01263496|183006875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.405|||||TWO_SIDED|95.0|-0.616|-0.195||||||||-0.195|-0.616|
91559137|NCT01263496|183006875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.583|||||TWO_SIDED|95.0|-0.78|-0.386||||||||-0.386|-0.780|
91559138|NCT01263496|183006876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||||TWO_SIDED|95.0|-0.41|0.065||||||||0.065|-0.410|
91559139|NCT01263496|183006876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|||||TWO_SIDED|95.0|-0.55|-0.088||||||||-0.088|-0.550|
91559140|NCT01263496|183006876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.601|-0.139||||||||-0.139|-0.601|
91559141|NCT01263496|183006876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|||||TWO_SIDED|95.0|-0.752|-0.314||||||||-0.314|-0.752|
91559142|NCT01263496|183006877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|||||TWO_SIDED|95.0|-0.323|0.166||||||||0.166|-0.323|
91559143|NCT01263496|183006877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|||||TWO_SIDED|95.0|-0.471|-0.011||||||||-0.011|-0.471|
91559144|NCT01263496|183006877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||||TWO_SIDED|95.0|-0.59|-0.124||||||||-0.124|-0.590|
91559145|NCT01263496|183006877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.467|||||TWO_SIDED|95.0|-0.692|-0.242||||||||-0.242|-0.692|
91559146|NCT01263496|183006878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.321|0.162||||||||0.162|-0.321|
91559147|NCT01263496|183006878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.294|||||TWO_SIDED|95.0|-0.542|-0.046||||||||-0.046|-0.542|
91559148|NCT01263496|183006878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.341|||||TWO_SIDED|95.0|-0.579|-0.103||||||||-0.103|-0.579|
91559149|NCT01263496|183006878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.487|||||TWO_SIDED|95.0|-0.722|-0.252||||||||-0.252|-0.722|
91559150|NCT01263496|183006879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.279|0.182||||||||0.182|-0.279|
91559151|NCT01263496|183006879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.234|||||TWO_SIDED|95.0|-0.491|0.023||||||||0.023|-0.491|
91559152|NCT01263496|183006879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375|||||TWO_SIDED|95.0|-0.605|-0.145||||||||-0.145|-0.605|
91559153|NCT01263496|183006879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.488|||||TWO_SIDED|95.0|-0.724|-0.252||||||||-0.252|-0.724|
91559154|NCT01263496|183006880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.27|0.169||||||||0.169|-0.270|
91559155|NCT01263496|183006880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-0.453|0.067||||||||0.067|-0.453|
91559156|NCT01263496|183006880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374|||||TWO_SIDED|95.0|-0.596|-0.152||||||||-0.152|-0.596|
91559157|NCT01263496|183006880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.723|-0.256||||||||-0.256|-0.723|
91559158|NCT01263496|183006881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||||TWO_SIDED|95.0|-0.16|0.289||||||||0.289|-0.160|
91559159|NCT01263496|183006881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.236|||||TWO_SIDED|95.0|-0.477|0.005||||||||0.005|-0.477|
91559160|NCT01263496|183006881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.608|-0.113||||||||-0.113|-0.608|
91559161|NCT01263496|183006881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.435|||||TWO_SIDED|95.0|-0.679|-0.191||||||||-0.191|-0.679|
91559162|NCT01263496|183006882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|||||TWO_SIDED|95.0|-0.262|0.196||||||||0.196|-0.262|
91559163|NCT01263496|183006882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.262|||||TWO_SIDED|95.0|-0.516|-0.008||||||||-0.008|-0.516|
91559164|NCT01263496|183006882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.358|||||TWO_SIDED|95.0|-0.614|-0.103||||||||-0.103|-0.614|
91559165|NCT01263496|183006882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|||||TWO_SIDED|95.0|-0.69|-0.174||||||||-0.174|-0.690|
91559166|NCT01263496|183006883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|||||TWO_SIDED|95.0|-0.346|0.11||||||||0.110|-0.346|
91559167|NCT01263496|183006883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||||TWO_SIDED|95.0|-0.539|-0.015||||||||-0.015|-0.539|
91559168|NCT01263496|183006883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|||||TWO_SIDED|95.0|-0.637|-0.109||||||||-0.109|-0.637|
91559169|NCT01263496|183006883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.477|||||TWO_SIDED|95.0|-0.741|-0.213||||||||-0.213|-0.741|
91559170|NCT01263496|183006884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|||||TWO_SIDED|95.0|-0.416|0.055||||||||0.055|-0.416|
91559171|NCT01263496|183006884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.245|||||TWO_SIDED|95.0|-0.492|0.003||||||||0.003|-0.492|
91559172|NCT01263496|183006884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.408|||||TWO_SIDED|95.0|-0.654|-0.161||||||||-0.161|-0.654|
91559173|NCT01263496|183006884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.638|||||TWO_SIDED|95.0|-0.874|-0.402||||||||-0.402|-0.874|
91559174|NCT01263496|183006885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.51|||||TWO_SIDED|95.0|-17.56|0.54||||||||0.54|-17.56|
91559175|NCT01263496|183006885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|||||TWO_SIDED|95.0|-19.23|-4.18||||||||-4.18|-19.23|
91559176|NCT01263496|183006885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.68|-6.15||||||||-6.15|-20.68|
91559177|NCT01263496|183006885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.38|||||TWO_SIDED|95.0|-26.93|-11.83||||||||-11.83|-26.93|
91559178|NCT01263496|183006886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-12.67|3.8||||||||3.80|-12.67|
91559179|NCT01263496|183006886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.39|||||TWO_SIDED|95.0|-17.48|-1.3||||||||-1.30|-17.48|
91768658|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-50.5|77.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||77.2|-50.5|1.000
91559180|NCT01263496|183006886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.56|||||TWO_SIDED|95.0|-18.58|-2.54||||||||-2.54|-18.58|
91559181|NCT01263496|183006886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||||TWO_SIDED|95.0|-21.44|-3.31||||||||-3.31|-21.44|
91559182|NCT01263496|183006887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-15.66|1.86||||||||1.86|-15.66|
91559183|NCT01263496|183006887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||||TWO_SIDED|95.0|-18.97|-2.49||||||||-2.49|-18.97|
91559184|NCT01263496|183006887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.21|||||TWO_SIDED|95.0|-17.2|-1.23||||||||-1.23|-17.20|
91559185|NCT01263496|183006887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.49|||||TWO_SIDED|95.0|-24.27|-6.72||||||||-6.72|-24.27|
91768659|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
91559186|NCT01263496|183006888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-11.22|6.67||||||||6.67|-11.22|
91559187|NCT01263496|183006888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36|||||TWO_SIDED|95.0|-12.16|5.44||||||||5.44|-12.16|
91559188|NCT01263496|183006888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||||TWO_SIDED|95.0|-13.3|2.44||||||||2.44|-13.30|
91559189|NCT01263496|183006888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||||TWO_SIDED|95.0|-20.74|-3.06||||||||-3.06|-20.74|
91559190|NCT01263496|183006889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-11.97|7.08||||||||7.08|-11.97|
91559191|NCT01263496|183006889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-15.84|3.35||||||||3.35|-15.84|
91559192|NCT01263496|183006889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|||||TWO_SIDED|95.0|-15.28|1.41||||||||1.41|-15.28|
91559193|NCT01263496|183006889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.73|||||TWO_SIDED|95.0|-22.67|-2.78||||||||-2.78|-22.67|
91559194|NCT01263496|183006890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.19|2.31||||||||2.31|-13.19|
91559195|NCT01263496|183006890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||||TWO_SIDED|95.0|-13.53|5.99||||||||5.99|-13.53|
91559196|NCT01263496|183006890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-14.36|2.67||||||||2.67|-14.36|
91559197|NCT01263496|183006890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.22|||||TWO_SIDED|95.0|-20.72|-1.73||||||||-1.73|-20.72|
91559198|NCT01263496|183006891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|||||TWO_SIDED|95.0|-10.42|5.9||||||||5.90|-10.42|
91559199|NCT01263496|183006891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-15.64|3.84||||||||3.84|-15.64|
91559200|NCT01263496|183006891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.47|||||TWO_SIDED|95.0|-16.52|-0.42||||||||-0.42|-16.52|
91559201|NCT01263496|183006891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||||TWO_SIDED|95.0|-22.18|-2.76||||||||-2.76|-22.18|
91559202|NCT01263496|183006892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-7.1|7.77||||||||7.77|-7.10|
91559203|NCT01263496|183006892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||||TWO_SIDED|95.0|-10.16|8.21||||||||8.21|-10.16|
91559204|NCT01263496|183006892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-9.71|5.95||||||||5.95|-9.71|
91559205|NCT01263496|183006892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.59|-0.18||||||||-0.18|-18.59|
91559206|NCT01263496|183006893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||||TWO_SIDED|95.0|-10.2|6.75||||||||6.75|-10.20|
91559207|NCT01263496|183006893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.1|5.7||||||||5.70|-13.10|
91559208|NCT01263496|183006893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97|||||TWO_SIDED|95.0|-12.94|5.0||||||||5.00|-12.94|
91559209|NCT01263496|183006893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.74|||||TWO_SIDED|95.0|-19.4|-0.08||||||||-0.08|-19.40|
91559210|NCT01263496|183006894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-11.0|6.15||||||||6.15|-11.00|
91559211|NCT01263496|183006894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|||||TWO_SIDED|95.0|-16.53|1.94||||||||1.94|-16.53|
91768660|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
91768661|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-40.0||||0.464|TWO_SIDED|95.0|-82.9|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||2.9|-82.9|0.464
91768662|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-50.0||||0.4|TWO_SIDED|95.0|-100.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||19.3|-100.0|0.400
91768663|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-46.7||||0.464|TWO_SIDED|95.0|-100.0|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||17.2|-100.0|0.464
91559212|NCT01263496|183006894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||||TWO_SIDED|95.0|-17.93|-0.67||||||||-0.67|-17.93|
91559213|NCT01263496|183006894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-21.83|-1.93||||||||-1.93|-21.83|
91559214|NCT01263496|183006895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-9.68|7.27||||||||7.27|-9.68|
91559215|NCT01263496|183006895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||||TWO_SIDED|95.0|-16.34|2.24||||||||2.24|-16.34|
91559216|NCT01263496|183006895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||||TWO_SIDED|95.0|-17.47|-0.26||||||||-0.26|-17.47|
91768664|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
91768665|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
91768666|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-26.7||||1|TWO_SIDED|95.0|-95.1|41.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||41.8|-95.1|1.000
91768667|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
91559217|NCT01263496|183006895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-23.12|-3.89||||||||-3.89|-23.12|
91768668|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
91768669|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-77.2|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-77.2|1.000
91559218|NCT01263496|183006896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||||TWO_SIDED|95.0|-10.09|6.8||||||||6.80|-10.09|
91559219|NCT01263496|183006896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.66|2.25||||||||2.25|-15.66|
91559220|NCT01263496|183006896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||||TWO_SIDED|95.0|-16.64|0.07||||||||0.07|-16.64|
91559221|NCT01263496|183006896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.82|||||TWO_SIDED|95.0|-27.39|-10.24||||||||-10.24|-27.39|
91559222|NCT01263496|183006897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.219|0.254||||||||0.254|-0.219|
91559223|NCT01263496|183006897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|0.002|0.451||||||||0.451|0.002|
91559224|NCT01263496|183006897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.008|0.453||||||||0.453|0.008|
91559225|NCT01263496|183006897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|||||TWO_SIDED|95.0|0.041|0.524||||||||0.524|0.041|
91559226|NCT01263496|183006898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-0.173|0.353||||||||0.353|-0.173|
91559227|NCT01263496|183006898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|||||TWO_SIDED|95.0|-0.01|0.467||||||||0.467|-0.010|
91559228|NCT01263496|183006898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|||||TWO_SIDED|95.0|0.095|0.584||||||||0.584|0.095|
91559229|NCT01263496|183006898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|||||TWO_SIDED|95.0|0.184|0.752||||||||0.752|0.184|
91559230|NCT01263496|183006899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|||||TWO_SIDED|95.0|0.064|0.57||||||||0.570|0.064|
91559231|NCT01263496|183006899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.511|||||TWO_SIDED|95.0|0.236|0.786||||||||0.786|0.236|
91768670|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-70.8|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|-70.8|1.000
91768671|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
91768672|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-33.8|40.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.4|-33.8|1.000
91768673|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.5|-15.2|0.408
91768674|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|33.3||||0.266|TWO_SIDED|95.0|9.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.2|9.5|0.266
91768675|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-33.3||||0.121|TWO_SIDED|95.0|-66.2|-0.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||-0.5|-66.2|0.121
91768676|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-10.0||||-10|TWO_SIDED|95.0|-34.6|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||14.6|-34.6|-10.0
91768677|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-6.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.3|-6.0|1.000
91768678|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-45.3|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.9|-45.3|1.000
91768679|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||48.5|-15.2|0.408
91768680|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||55.7|-29.1|1.000
91559232|NCT01263496|183006899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|||||TWO_SIDED|95.0|0.19|0.685||||||||0.685|0.190|
91559233|NCT01263496|183006899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|||||TWO_SIDED|95.0|0.413|1.022||||||||1.022|0.413|
91559234|NCT01263496|183006900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|-0.029|0.481||||||||0.481|-0.029|
91559235|NCT01263496|183006900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|||||TWO_SIDED|95.0|0.104|0.612||||||||0.612|0.104|
91559236|NCT01263496|183006900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|0.076|0.54||||||||0.540|0.076|
91559237|NCT01263496|183006900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|0.098|0.565||||||||0.565|0.098|
91559238|NCT01263496|183006901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.13|0.41||||||||0.410|-0.130|
91559239|NCT01263496|183006901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|||||TWO_SIDED|95.0|-0.026|0.516||||||||0.516|-0.026|
91559240|NCT01263496|183006901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|||||TWO_SIDED|95.0|0.035|0.552||||||||0.552|0.035|
91559241|NCT01263496|183006901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|||||TWO_SIDED|95.0|0.032|0.626||||||||0.626|0.032|
91559242|NCT01263496|183006902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.252|0.349||||||||0.349|-0.252|
91559243|NCT01263496|183006902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|0.138|0.703||||||||0.703|0.138|
91559244|NCT01263496|183006902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|95.0|0.178|0.742||||||||0.742|0.178|
91559245|NCT01263496|183006902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.384|||||TWO_SIDED|95.0|0.085|0.683||||||||0.683|0.085|
91559246|NCT01263496|183006903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.257|0.326||||||||0.326|-0.257|
91559247|NCT01263496|183006903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|||||TWO_SIDED|95.0|-0.043|0.542||||||||0.542|-0.043|
91559248|NCT01263496|183006903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|||||TWO_SIDED|95.0|-0.196|0.417||||||||0.417|-0.196|
91559249|NCT01263496|183006903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||||TWO_SIDED|95.0|0.01|0.656||||||||0.656|0.010|
91559250|NCT01263496|183006904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.268|||||TWO_SIDED|95.0|-0.769|0.233||||||||0.233|-0.769|
91559251|NCT01263496|183006904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349|||||TWO_SIDED|95.0|-0.156|0.855||||||||0.855|-0.156|
91559252|NCT01263496|183006904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.297|0.577||||||||0.577|-0.297|
91559253|NCT01263496|183006904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|-0.075|0.69||||||||0.690|-0.075|
91559254|NCT01263496|183006905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|-0.367|0.928||||||||0.928|-0.367|
91559255|NCT01263496|183006905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.579|||||TWO_SIDED|95.0|-0.035|1.194||||||||1.194|-0.035|
91559256|NCT01263496|183006905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.647|||||TWO_SIDED|95.0|0.054|1.241||||||||1.241|0.054|
91559257|NCT01263496|183006905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|||||TWO_SIDED|95.0|-0.28|0.785||||||||0.785|-0.280|
91559258|NCT01263496|183006906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.246|0.646||||||||0.646|-1.246|
91559259|NCT01263496|183006906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|||||TWO_SIDED|95.0|-0.305|1.591||||||||1.591|-0.305|
91559260|NCT01263496|183006906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.599|0.888||||||||0.888|-0.599|
91559261|NCT01263496|183006906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.673|1.173||||||||1.173|-0.673|
91559262|NCT01263496|183006907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-4.462|2.562||||||||2.562|-4.462|
91559263|NCT01263496|183006907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|||||TWO_SIDED|95.0|-2.712|2.779||||||||2.779|-2.712|
91559264|NCT01263496|183006907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.273|2.073||||||||2.073|-3.273|
91559265|NCT01263496|183006907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.874|2.074||||||||2.074|-2.874|
91559266|NCT01263496|183006908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||||TWO_SIDED|95.0|-0.14|0.458||||||||0.458|-0.140|
91559267|NCT01263496|183006908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.001|0.52||||||||0.520|-0.001|
91559268|NCT01263496|183006908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||||TWO_SIDED|95.0|-0.126|0.398||||||||0.398|-0.126|
91559269|NCT01263496|183006908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.298|||||TWO_SIDED|95.0|0.042|0.553||||||||0.553|0.042|
91559270|NCT01263496|183006909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92|||||TWO_SIDED|95.0|-11.82|7.99||||||||7.99|-11.82|
91559271|NCT01263496|183006909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-12.45|6.4||||||||6.40|-12.45|
91559272|NCT01263496|183006909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||||TWO_SIDED|95.0|-18.77|1.96||||||||1.96|-18.77|
91559273|NCT01263496|183006909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||||TWO_SIDED|95.0|-18.35|0.44||||||||0.44|-18.35|
91559274|NCT01263496|183006910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||||TWO_SIDED|95.0|-3.88|19.19||||||||19.19|-3.88|
91559275|NCT01263496|183006910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-11.41|9.24||||||||9.24|-11.41|
91559276|NCT01263496|183006910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-12.91|10.75||||||||10.75|-12.91|
91559277|NCT01263496|183006910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-11.32|9.99||||||||9.99|-11.32|
91559278|NCT01263496|183006911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-7.09|16.49||||||||16.49|-7.09|
91559279|NCT01263496|183006911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||||TWO_SIDED|95.0|-8.63|11.89||||||||11.89|-8.63|
91559280|NCT01263496|183006911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-13.36|7.98||||||||7.98|-13.36|
91559281|NCT01263496|183006911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.58|2.17||||||||2.17|-20.58|
91559282|NCT01263496|183006912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-11.44|9.84||||||||9.84|-11.44|
91559283|NCT01263496|183006912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||||TWO_SIDED|95.0|-11.74|7.66||||||||7.66|-11.74|
91559284|NCT01263496|183006912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-15.62|4.75||||||||4.75|-15.62|
91559285|NCT01263496|183006912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.28|||||TWO_SIDED|95.0|-23.83|-2.74||||||||-2.74|-23.83|
91559286|NCT01263496|183006913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||||TWO_SIDED|95.0|-28.15|14.1||||||||14.10|-28.15|
91559287|NCT01263496|183006913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-23.93|13.02||||||||13.02|-23.93|
91559288|NCT01263496|183006913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||||TWO_SIDED|95.0|-35.46|-0.13||||||||-0.13|-35.46|
91559289|NCT01263496|183006913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.58|||||TWO_SIDED|95.0|-47.75|-13.41||||||||-13.41|-47.75|
91559290|NCT01263496|183006914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|||||TWO_SIDED|95.0|-5.18|42.09||||||||42.09|-5.18|
91559291|NCT01263496|183006914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.86|||||TWO_SIDED|95.0|-13.56|33.28||||||||33.28|-13.56|
91559292|NCT01263496|183006914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.44|||||TWO_SIDED|95.0|-30.25|15.37||||||||15.37|-30.25|
91559293|NCT01263496|183006914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-34.75|9.15||||||||9.15|-34.75|
91559294|NCT01263496|183006915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.84|||||TWO_SIDED|95.0|-13.9|25.58||||||||25.58|-13.90|
91559295|NCT01263496|183006915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.35|||||TWO_SIDED|95.0|-18.2|24.9||||||||24.90|-18.20|
91559296|NCT01263496|183006915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-26.03|18.74||||||||18.74|-26.03|
91559297|NCT01263496|183006915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.37|||||TWO_SIDED|95.0|-47.08|0.34||||||||0.34|-47.08|
91559298|NCT01263496|183006916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-18.77|24.71||||||||24.71|-18.77|
91559299|NCT01263496|183006916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-21.21|23.94||||||||23.94|-21.21|
91559300|NCT01263496|183006916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||||TWO_SIDED|95.0|-32.69|10.3||||||||10.30|-32.69|
91559301|NCT01263496|183006916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.9|||||TWO_SIDED|95.0|-56.85|-12.96||||||||-12.96|-56.85|
91559302|NCT01263496|183006917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.955|||||TWO_SIDED|95.0|0.375|1.535||||||||1.535|0.375|
91559303|NCT01263496|183006917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.752|1.965||||||||1.965|0.752|
91559304|NCT01263496|183006917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||||TWO_SIDED|95.0|0.724|1.975||||||||1.975|0.724|
91559305|NCT01263496|183006917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|0.804|1.955||||||||1.955|0.804|
91559306|NCT01263496|183006918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.034|||||TWO_SIDED|95.0|0.344|1.723||||||||1.723|0.344|
91559307|NCT01263496|183006918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.448|||||TWO_SIDED|95.0|0.78|2.115||||||||2.115|0.780|
91559308|NCT01263496|183006918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.243|||||TWO_SIDED|95.0|0.616|1.87||||||||1.870|0.616|
91559309|NCT01263496|183006918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.481|||||TWO_SIDED|95.0|0.827|2.136||||||||2.136|0.827|
91559310|NCT01263496|183006919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-4.088|4.188||||||||4.188|-4.088|
91559311|NCT01263496|183006919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.585|||||TWO_SIDED|95.0|-3.476|6.647||||||||6.647|-3.476|
91559312|NCT01263496|183006919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-8.151|9.184||||||||9.184|-8.151|
91559313|NCT01263496|183006919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277|||||TWO_SIDED|95.0|-2.191|4.744||||||||4.744|-2.191|
91559314|NCT01263496|183006920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.841|||||TWO_SIDED|95.0|0.239|1.443||||||||1.443|0.239|
91559315|NCT01263496|183006920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.304|||||TWO_SIDED|95.0|0.679|1.93||||||||1.930|0.679|
91559316|NCT01263496|183006920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.992|||||TWO_SIDED|95.0|0.4|1.585||||||||1.585|0.400|
91559317|NCT01263496|183006920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|||||TWO_SIDED|95.0|0.674|1.853||||||||1.853|0.674|
91559318|NCT01263496|183006921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.891|||||TWO_SIDED|95.0|9.597|22.184||||||||22.184|9.597|
91559319|NCT01263496|183006921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.026|||||TWO_SIDED|95.0|12.466|23.585||||||||23.585|12.466|
91559320|NCT01263496|183006921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.838|||||TWO_SIDED|95.0|14.379|25.297||||||||25.297|14.379|
91559321|NCT01263496|183006921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.368|||||TWO_SIDED|95.0|8.677|22.06||||||||22.060|8.677|
91559322|NCT01263496|183006922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.323|||||TWO_SIDED|95.0|6.567|22.079||||||||22.079|6.567|
91559323|NCT01263496|183006922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.714|||||TWO_SIDED|95.0|14.563|26.864||||||||26.864|14.563|
91559324|NCT01263496|183006922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.063|||||TWO_SIDED|95.0|13.125|25.002||||||||25.002|13.125|
91559325|NCT01263496|183006922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.233|||||TWO_SIDED|95.0|6.618|23.847||||||||23.847|6.618|
91559326|NCT01263496|183006923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.047|||||TWO_SIDED|95.0|1.169|14.924||||||||14.924|1.169|
91559327|NCT01263496|183006923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.95|||||TWO_SIDED|95.0|7.767|20.133||||||||20.133|7.767|
91559328|NCT01263496|183006923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.221|||||TWO_SIDED|95.0|9.191|21.251||||||||21.251|9.191|
91559329|NCT01263496|183006923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.366|||||TWO_SIDED|95.0|5.847|20.885||||||||20.885|5.847|
91559330|NCT01263496|183006924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.719|||||TWO_SIDED|95.0|1.657|13.782||||||||13.782|1.657|
91559331|NCT01263496|183006924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.978|||||TWO_SIDED|95.0|7.556|18.399||||||||18.399|7.556|
91559332|NCT01263496|183006924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.076|||||TWO_SIDED|95.0|9.808|20.345||||||||20.345|9.808|
91559333|NCT01263496|183006924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.087|||||TWO_SIDED|95.0|6.561|19.614||||||||19.614|6.561|
91559334|NCT01263496|183006925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.76|||||TWO_SIDED|95.0|-7.03|20.55||||||||20.55|-7.03|
91559335|NCT01263496|183006925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.85|||||TWO_SIDED|95.0|-1.49|25.19||||||||25.19|-1.49|
91559336|NCT01263496|183006925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.72|||||TWO_SIDED|95.0|-5.12|24.56||||||||24.56|-5.12|
91559337|NCT01263496|183006925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-13.26|14.9||||||||14.90|-13.26|
91559338|NCT01263496|183006926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-11.11|22.91||||||||22.91|-11.11|
91559339|NCT01263496|183006926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||||TWO_SIDED|95.0|-7.21|28.35||||||||28.35|-7.21|
91559340|NCT01263496|183006926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.45|||||TWO_SIDED|95.0|-10.08|26.98||||||||26.98|-10.08|
91559341|NCT01263496|183006926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.82|||||TWO_SIDED|95.0|-10.67|24.3||||||||24.30|-10.67|
91559342|NCT01263496|183006927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||||TWO_SIDED|95.0|-14.95|21.13||||||||21.13|-14.95|
91559343|NCT01263496|183006927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-15.61|20.57||||||||20.57|-15.61|
91559344|NCT01263496|183006927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-21.0|19.68||||||||19.68|-21.00|
91559345|NCT01263496|183006927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||||TWO_SIDED|95.0|-17.47|20.05||||||||20.05|-17.47|
91559346|NCT01263496|183006928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|95.0|-11.7|19.86||||||||19.86|-11.70|
91559347|NCT01263496|183006928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94|||||TWO_SIDED|95.0|-11.14|21.03||||||||21.03|-11.14|
91559348|NCT01263496|183006928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||||TWO_SIDED|95.0|-14.42|21.73||||||||21.73|-14.42|
91768681|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-26.7||||0.241|TWO_SIDED|95.0|-65.3|11.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||11.9|-65.3|0.241
91559349|NCT01263496|183006928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-17.24|15.89||||||||15.89|-17.24|
91559350|NCT02203032|183006930|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
91559351|NCT02203032|183006931|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
91559352|NCT02203032|183006932|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
91559353|NCT02203032|183006933|SUPERIORITY_OR_OTHER||||||=|0.001|||||||Cochran-Mantel-Haenszel|||||||= 0.001
91559354|NCT01836445|183006946|SUPERIORITY||Prevalence Ratio|0.9||||0.2|TWO_SIDED|95.0|0.76|1.06|||Regression, Logistic|||||1.06|0.76|0.20
91559355|NCT01836445|183006947|SUPERIORITY||Prevalence Ratio|0.95||||0.6|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic|||||1.14|0.80|0.60
91559356|NCT01836445|183006948|SUPERIORITY||Prevalence Ratio|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Regression, Logistic|||||0.99|0.70|0.04
91559357|NCT01836445|183006950|SUPERIORITY||Risk Ratio (RR)|0.6||||0.01|TWO_SIDED|95.0|0.38|0.95|||Z-test|||||0.95|0.38|0.01
91559358|NCT01836445|183006951|OTHER|Generalized Linear Mixed Model statistical test used||||||0.15|||||||Regression, Linear|||||||0.150
91559359|NCT01836445|183006952|OTHER|Generalized Linear Mixed Model statistical test used||||||0.374|||||||Regression, Linear|||||||0.374
91559360|NCT01836445|183006953|OTHER|Generalized Linear Mixed Model statistical test used||||||0.919|||||||Regression, Linear|||Analysis for Motivation items||||0.919
91559361|NCT01836445|183006953|OTHER|Generalized Linear Mixed Model statistical test used||||||0.493|||||||Regression, Linear|||Analysis for Social Norms items||||0.493
91559362|NCT01836445|183006953|OTHER|Generalized Linear Mixed Model statistical test used||||||0.002|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.002
91559363|NCT01836445|183006954|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.067
91559364|NCT01836445|183006954|OTHER|Generalized Linear Mixed Model statistical test used||||||0.135|||||||Regression, Linear|||Analysis for Condom Use items||||0.135
91559365|NCT01836445|183006954|OTHER|Generalized Linear Mixed Model statistical test used||||||0.025|||||||Regression, Linear|||Analysis for HIV Testing items||||0.025
91559366|NCT01836445|183006955|OTHER|Generalized Linear Mixed Model statistical test used||||||0.138|||||||Regression, Logistic|||||||0.138
91559367|NCT01836445|183006956|OTHER|Generalized Linear Mixed Model statistical test used||||||0.173|||||||Regression, Linear|||||||0.173
91559368|NCT01836445|183006957|OTHER|Generalized Linear Mixed Model statistical test used||||||0.567|||||||Regression, Linear|||||||0.567
91559369|NCT01836445|183006958|OTHER|Generalized Linear Mixed Model statistical test used||||||0.861|||||||Regression, Linear|||Analysis for motivation items||||0.861
91559370|NCT01836445|183006958|OTHER|Generalized Linear Mixed Model statistical test used||||||0.628|||||||Regression, Linear|||Analysis for social norms items||||0.628
91559371|NCT01836445|183006958|OTHER|Generalized Linear Mixed Model statistical test used||||||0.151|||||||Regression, Linear|||Analysis for behavioral skills items||||0.151
91559372|NCT01836445|183006959|OTHER|Generalized Linear Mixed Model statistical test used||||||0.001|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.001
91559373|NCT01836445|183006959|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Condom Use items||||0.067
91559374|NCT01836445|183006959|OTHER|Generalized Linear Mixed Model statistical test used||||||0.637|||||||Regression, Linear|||Analysis for HIV Testing items||||0.637
91559375|NCT01836445|183006960|OTHER|Generalized Linear Mixed Model statistical test used||||||0.862|||||||Regression, Linear|||||||0.862
91559376|NCT01836445|183006961|OTHER|Generalized Linear Mixed Model statistical test used||||||0.762|||||||Regression, Linear|||||||0.762
91559377|NCT01836445|183006962|SUPERIORITY|||||||0.043|||||||Regression, Linear|||Analysis for Motivation items||||0.043
91559378|NCT01836445|183006962|SUPERIORITY|||||||0.617|||||||Regression, Linear|||Analysis for Social Norm items||||0.617
91559379|NCT01836445|183006962|SUPERIORITY|||||||0.57|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.570
91559380|NCT01836445|183006963|SUPERIORITY|||||||0.036|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.036
91559381|NCT01836445|183006963|SUPERIORITY|||||||0.837|||||||Regression, Linear|||Analysis for Condom Use items||||0.837
91559382|NCT01836445|183006963|SUPERIORITY|||||||0.953|||||||Regression, Linear|||Analysis for HIV Testing items||||0.953
91559383|NCT01836445|183006964|SUPERIORITY|||||||0.719|||||||Regression, Linear|||||||0.719
91559384|NCT00535626|183007006|OTHER|"To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis).~Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients."|Revision or Pending Revision Rate|2.43|||||TWO_SIDED|90.0|1.07|5.46|||||The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.|||5.46|1.07|
91559385|NCT00535626|183007007|OTHER|To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
91559386|NCT00535626|183007008|OTHER|To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
91559387|NCT00535626|183007008|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.||||||0.0139|||||||t-test, 2 sided|Paired t-test||||||0.0139
91559388|NCT00535626|183007008|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.||||||0.0254|||||||t-test, 2 sided|Paired t-test||||||0.0254
91559389|NCT00535626|183007008|OTHER|To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.||||||0.1506|||||||t-test, 2 sided|Paired t-test||||||0.1506
91559390|NCT00535626|183007008|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.||||||0.0936|||||||t-test, 2 sided|Paired t-test||||||0.0936
91559391|NCT00535626|183007008|OTHER|To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.||||||0.0909|||||||t-test, 2 sided|Paired t-test||||||0.0909
91559392|NCT00535626|183007008|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.||||||0.048|||||||t-test, 2 sided|Paired t-test||||||0.048
91559393|NCT00535626|183007011|OTHER|To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.||||||0.0011|||||||t-test, 2 sided|Paired t-test||||||0.0011
91559394|NCT00535626|183007011|OTHER|To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.|||||<|0.0001||||||This p-value applies to pre-op to 1, 2 and 3 year intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
91559395|NCT00535626|183007011|OTHER|To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.||||||0.0002|||||||t-test, 2 sided|Paired t-test||||||0.0002
91559396|NCT00535626|183007011|OTHER|To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.||||||0.0009|||||||t-test, 2 sided|Paired t-test||||||0.0009
91559397|NCT01093690|183007033|SUPERIORITY_OR_OTHER|||||||0.41||||||No adjustment.|Chi-squared|1-sided test||the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)||||0.41
91559398|NCT02236611|183007035|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus glycopyrronium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.|Mean Difference (Final Values)|0.024||||0.1|TWO_SIDED|95.0|-0.005|0.054|||Mixed Models Analysis|||||0.054|-0.005|0.100
91559399|NCT01332266|183007063|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.46||||||||1.46|0.54|
91559400|NCT01332266|183007065|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.61|1.73||||||||1.73|0.61|
91559401|NCT01332266|183007066|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.37||||||||1.37|0.53|
91559402|NCT03302091|183007068|OTHER||Adjusted gMean ratio (T/R)%|198.5|STANDARD_DEVIATION|96.5|||TWO_SIDED|90.0|101.83|386.94|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||386.94|101.83|
91559403|NCT03302091|183007069|OTHER||Adjusted gMean ratio (T/R)%|198.42|STANDARD_DEVIATION|77.5|||TWO_SIDED|90.0|116.56|337.78|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||337.78|116.56|
91559404|NCT03302091|183007070|OTHER||Adjusted gMean ratio (T/R)%|226.29|STANDARD_DEVIATION|47.5|||TWO_SIDED|90.0|156.35|327.53|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||327.53|156.35|
91559405|NCT03302091|183007071|OTHER||Adjusted gMean ratio (T/R)%|140.4|STANDARD_DEVIATION|32.8|||TWO_SIDED|90.0|108.06|182.43|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||182.43|108.06|
91559406|NCT03302091|183007072|OTHER||Adjusted gMean ratio (T/R)%|165.63|STANDARD_DEVIATION|56.6|||TWO_SIDED|90.0|107.51|255.17|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||255.17|107.51|
91559407|NCT03302091|183007073|OTHER||Adjusted gMean ratio (T/R)%|128.44|STANDARD_DEVIATION|31.7|||TWO_SIDED|90.0|99.64|165.57|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||165.57|99.64|
91768682|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||48.5|-15.2|0.408
91768683|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||55.7|-29.1|1.000
91768684|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-43.3|36.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.6|-43.3|1.000
91559408|NCT01686152|183007074|EQUIVALENCE|The test product was determined to be bioequivalent to the reference product if the 90% confidence interval was within -0.20 to 0.20.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.0663|0.0913||||||||0.0913|-0.0663|
91559409|NCT01802333|183007075|OTHER|||||||0.84|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.84
91559410|NCT01802333|183007075|OTHER|||||||0.42|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.42
91559411|NCT01802333|183007076|OTHER||||||<|0.0001|||||||Exact binomial test, 1-sided|||||||<0.0001
91559412|NCT01802333|183007078|OTHER|||||||0.52|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).||||0.52
91559413|NCT02551224|183007086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||<|0.0001|TWO_SIDED|95.0|0.51|0.99|||Wilcoxon (Mann-Whitney)|||||0.99|0.51|<0.0001
91559414|NCT02551224|183007087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.21|0.61|||Wilcoxon (Mann-Whitney)|||||0.61|0.21|<0.0001
91559415|NCT01947491|183007088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91559416|NCT02224755|183007097|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|9.4|||<|0.001|ONE_SIDED|95.0|-2.1||||Farrington-Manning risk difference||||||-2.1|<0.001
91559417|NCT02224755|183007098|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|19.2|||<|0.001|ONE_SIDED|95.0|9.8||||Farrington-Manning risk difference||||||9.8|<0.001
91559418|NCT02224755|183007099|SUPERIORITY||Risk Ratio (RR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Fisher Exact|||Based on data in the Sponsor's device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher's exact test.||.38|.11|<0.001
91559419|NCT01205126|183007115|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.855|TWO_SIDED|95.0|-1.3|1.1||P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|ANCOVA|||||1.1|-1.3|0.855
91559420|NCT01205126|183007116|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.615|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.6|-1.0|0.615
91559421|NCT01205126|183007117|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.621|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.7|-1.1|0.621
91559422|NCT01205126|183007118|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.832|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||||0.832
91559423|NCT01205126|183007119|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.304|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29||||||0.304
91559424|NCT01205126|183007120|SUPERIORITY_OR_OTHER|||||||0.276|||||||rank sum test, 2 sided|||||||0.276
91768685|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|30.0||||0.217|TWO_SIDED|95.0|-2.9|62.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||62.9|-2.9|0.217
91768686|NCT02365649|183425716|SUPERIORITY||Risk Difference (RD)|26.7||||0.603|TWO_SIDED|95.0|-16.5|69.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.9|-16.5|0.603
91559425|NCT00321971|183007201|SUPERIORITY||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.208|0.657|||Mixed Models Analysis|Intention-to-treat model|The CES-D data were log-transformed for analysis|Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.||0.657|0.208|<.05
91559426|NCT00923078|183007245|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.02|<|0.05|TWO_SIDED|95.0|0.17|4.23|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||4.23|0.17|<0.05
91559427|NCT00923078|183007245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|1.02||0.48|TWO_SIDED|95.0|-2.75|1.31|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.31|-2.75|0.48
91559428|NCT00923078|183007245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|1.02|<|0.01|TWO_SIDED|95.0|-4.95|-0.9|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.90|-4.95|<0.01
91559429|NCT00923078|183007246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.295|<|0.05|TWO_SIDED|95.0|0.08|1.25|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.25|0.08|<0.05
91559430|NCT00923078|183007246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.295||0.09|TWO_SIDED|95.0|-0.08|1.09|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.09|-0.08|0.09
91559431|NCT00923078|183007246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.295||0.59|TWO_SIDED|95.0|-0.75|0.43|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.43|-0.75|0.59
91559432|NCT00923078|183007247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03|STANDARD_ERROR_OF_MEAN|0.75|<|0.01|TWO_SIDED|95.0|-3.53|-0.52||Post-test scores following Auditory Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.52|-3.53|<0.01
91559433|NCT00923078|183007247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|0.75||0.01|TWO_SIDED|95.0|-3.95|-0.94||Post-test scores following Visual Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.94|-3.95|0.01
91559434|NCT00923078|183007247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.75||0.58|TWO_SIDED|95.0|-1.93|1.08||Post-test scores following Auditory Cognitive Training as compared to Visual Cognitive Training, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.08|-1.93|0.58
91559435|NCT00923078|183007248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.55||0.06|TWO_SIDED|95.0|-6.02|0.18|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.18|-6.02|0.06
91559436|NCT00923078|183007248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.24|STANDARD_ERROR_OF_MEAN|1.55|<|0.05|TWO_SIDED|95.0|-6.34|-0.14|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.14|-6.34|< 0.05
91559437|NCT00923078|183007248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.55||0.84|TWO_SIDED|95.0|-3.42|2.78|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.78|-3.42|0.84
91559438|NCT00923078|183007249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.04||0.55|TWO_SIDED|95.0|-1.45|2.69|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.69|-1.45|0.55
91559439|NCT00923078|183007249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|1.03||0.98|TWO_SIDED|95.0|-2.02|2.07|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.07|-2.02|0.98
91559440|NCT00923078|183007249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.04||0.57|TWO_SIDED|95.0|-2.66|1.47|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.47|-2.66|0.57
91768687|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||52.6|-27.6|0.686
91559441|NCT00923078|183007250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|1.27||0.63|TWO_SIDED|95.0|-3.14|1.93|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.93|-3.14|0.63
91559442|NCT00923078|183007250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|1.27||0.47|TWO_SIDED|95.0|-3.45|1.61|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.61|-3.45|0.47
91768688|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
91768689|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||27.4|-47.4|0.709
91768690|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|3.7||||1|TWO_SIDED|95.0|-16.6|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.1|-16.6|1.000
91768691|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|8.5||||0.428|TWO_SIDED|95.0|-6.1|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.0|-6.1|0.428
91768692|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|6.8||||0.639|TWO_SIDED|95.0|-9.3|22.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||22.9|-9.3|0.639
91559443|NCT00923078|183007250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.27||0.8|TWO_SIDED|95.0|-2.85|2.22|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.22|-2.85|0.80
91559444|NCT00923078|183007251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.26|TWO_SIDED|95.0|-3.06|0.85|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.85|-3.06|0.26
91559445|NCT00923078|183007251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|0.97||0.13|TWO_SIDED|95.0|-3.41|0.46|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.46|-3.41|0.13
91559446|NCT00923078|183007251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.98||0.71|TWO_SIDED|95.0|-2.32|1.58|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.58|-2.32|0.71
91559447|NCT01072149|183007264|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.233|||<|0.001|TWO_SIDED|95.0|0.179|0.287|||Mixed Models Analysis|||||0.287|0.179|<0.001
91559448|NCT01072149|183007264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|||<|0.001|TWO_SIDED|95.0|0.165|0.275|||Mixed Models Analysis|||||0.275|0.165|<0.001
91559449|NCT01072149|183007264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||<|0.001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|||||0.291|0.181|<0.001
91559450|NCT01102426|183007274|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0054|TWO_SIDED|95.0|0.447|0.885||Cox regression: HR p=0.0062|Log Rank|||||0.885|0.447|=0.0054
91559451|NCT01102426|183007275|SUPERIORITY|||||||0.0618|||||||Normal approximation|||||||0.0618
91559452|NCT01102426|183007276|SUPERIORITY||Hazard Ratio (HR)|0.512|||<|0.0001|TWO_SIDED|95.0|0.382|0.686||Cox regression HR: p\<0.0001|Log Rank|||||0.686|0.382|< 0.0001
91559453|NCT01102426|183007277|SUPERIORITY|||||||0.0002|||||||Normal approximation|||||||0.0002
91559454|NCT01102426|183007278|SUPERIORITY||Hazard Ratio (HR)|0.797|||=|0.1261|TWO_SIDED|95.0|0.596|1.067||Cox regression HR: p=0.1273|Log Rank|||Pre-specified||1.067|0.596|=0.1261
91559455|NCT01102426|183007279|SUPERIORITY|||||||0.3625|||||||Normal approximation|||||||0.3625
91559456|NCT01102426|183007280|SUPERIORITY|||||||0.1037|||||||Normal approximation|||||||0.1037
91559457|NCT01102426|183007281|SUPERIORITY||Hazard Ratio (HR)|0.384|||=|0.1015|TWO_SIDED|95.0|0.113|1.303||Cox regression HR: 0.1247|Log Rank|||||1.303|0.113|=0.1015
91559458|NCT01102426|183007283|SUPERIORITY||Hazard Ratio (HR)|0.043|||=|0.0001|TWO_SIDED|95.0|0.004|0.479||Cox regression HR: 0.0105|Log Rank|||Pre-specified||0.479|0.004|=0.0001
91559459|NCT01102426|183007286|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91559460|NCT01102426|183007287|SUPERIORITY|||||||0.0085|||||||Fisher Exact|||||||0.0085
91559461|NCT01102426|183007289|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
91559462|NCT01102426|183007290|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
91559463|NCT03879538|183007304|SUPERIORITY||Mean Difference (Net)|-0.57||||0.19|TWO_SIDED|95.0|-1.42|0.28||a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of pain score assessed at one-week and one-month follow-up after end of treatment for Nitrous Oxide group equals that assessed at same time points for the Control group.||0.28|-1.42|0.19
91559464|NCT03879538|183007305|SUPERIORITY||Mean Difference (Net)|0.13||||0.36|TWO_SIDED|95.0|-0.16|0.43||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of physical health Z-score between two study groups: mean of physical health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.43|-0.16|0.36
91559465|NCT03879538|183007305|SUPERIORITY||Mean Difference (Net)|0.087||||0.66|TWO_SIDED|95.0|-0.31|0.48||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of mental health Z-score between two study groups: mean of mental health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.48|-0.31|0.66
91559466|NCT03879538|183007306|SUPERIORITY||Mean Difference (Net)|-0.7||||0.23|TWO_SIDED|95.0|-1.85|0.46||a priori threshold for statistical significance is p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of PGIC scale assessed at one-week and one-month follow-up time points for Nitrous Oxide patients is equal to that assessed at the same time points for Control patients.||0.46|-1.85|0.23
91559467|NCT00666705|183007317|SUPERIORITY_OR_OTHER||Ratio (percent)|85.76||||||90.0|79.89|92.07|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).||92.07|79.89|
91559468|NCT00666705|183007318|SUPERIORITY_OR_OTHER||Ratio (percent)|79.48||||||90.0|67.19|94.02|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).||94.02|67.19|
91559469|NCT00666705|183007319|SUPERIORITY_OR_OTHER||Ratio (percent)|63.25||||||90.0|44.27|90.39|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.||90.39|44.27|
91559470|NCT00666705|183007320|SUPERIORITY_OR_OTHER||Ratio (percent)|90.33||||||90.0|85.28|95.68|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.||95.68|85.28|
91559471|NCT00666705|183007321|SUPERIORITY_OR_OTHER||Ratio (percent)|66.77||||||90.0|41.22|108.15|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.||108.15|41.22|
91559472|NCT00666705|183007322|SUPERIORITY_OR_OTHER||ratio (percent)|72.42||||||90.0|57.82|90.71|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|||90.71|57.82|
91559473|NCT01029704|183007332|SUPERIORITY||Difference of LS Means|-16.923||||0.0989|TWO_SIDED|95.0|-37.076|3.23||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.230|-37.076|0.0989
91559474|NCT01029704|183007332|SUPERIORITY||Difference of LS Means|-17.834||||0.0964|TWO_SIDED|95.0|-38.909|3.242||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.242|-38.909|0.0964
91559475|NCT01029704|183007332|SUPERIORITY||Difference of LS Means|-19.991||||0.0465|TWO_SIDED|95.0|-39.67|-0.312||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.312|-39.670|0.0465
91559476|NCT01029704|183007332|SUPERIORITY||Difference of LS Means|-32.01||||0.0015|TWO_SIDED|95.0|-51.487|-12.533||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-12.533|-51.487|0.0015
91559477|NCT01029704|183007334|SUPERIORITY||Difference of LS Means|-1.434||||0.0025|TWO_SIDED|95.0|-2.349|-0.52||P-values are from a two-sided test.|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.520|-2.349|0.0025
91559478|NCT01029704|183007334|SUPERIORITY||Difference of LS Means|-1.037||||0.0269|TWO_SIDED|95.0|-1.952|-0.122||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.122|-1.952|0.0269
91559479|NCT01029704|183007334|SUPERIORITY||Difference of LS Means|-2.054|||<|0.0001|TWO_SIDED|95.0|-2.938|-1.17||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-1.170|-2.938|< 0.0001
91559480|NCT01029704|183007334|SUPERIORITY||Difference of LS Means|-1.172||||0.009|TWO_SIDED|95.0|-2.044|-0.301||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.301|-2.044|0.0090
91559481|NCT01029704|183007335|SUPERIORITY||Difference of LS Means|-0.353||||0.0281|TWO_SIDED|95.0|-0.668|-0.039||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.039|-0.668|0.0281
91559482|NCT01029704|183007335|SUPERIORITY||Difference of LS Means|-0.155||||0.3215|TWO_SIDED|95.0|-0.464|0.154||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.154|-0.464|0.3215
91559483|NCT01029704|183007335|SUPERIORITY||Difference of LS Means|-0.004||||0.9776|TWO_SIDED|95.0|-0.304|0.295||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.295|-0.304|0.9776
91559484|NCT01029704|183007335|SUPERIORITY||Difference of LS Means|-0.344||||0.0242|TWO_SIDED|95.0|-0.642|-0.046||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.046|-0.642|0.0242
91559485|NCT01029704|183007337|SUPERIORITY||Difference of LS Means|17.688||||0.1613|TWO_SIDED|95.0|-7.21|42.587||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||42.587|-7.210|0.1613
91559486|NCT01029704|183007337|SUPERIORITY||Difference of LS Means|17.091||||0.2079|TWO_SIDED|95.0|-9.696|43.877||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||43.877|-9.696|0.2079
91559487|NCT01029704|183007337|SUPERIORITY||Difference of LS Means|24.379||||0.041|TWO_SIDED|95.0|1.028|47.731||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||47.731|1.028|0.0410
91559488|NCT01029704|183007337|SUPERIORITY||Difference of LS Means|20.749||||0.0862|TWO_SIDED|95.0|-3.019|44.518||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||44.518|-3.019|0.0862
91559489|NCT03845517|183007339|SUPERIORITY||Risk Difference (RD)|-7.5||||0.8076|TWO_SIDED|95.0|-24.5|9.5||One sided p-value.|Cochran-Mantel-Haenszel|||||9.5|-24.5|0.8076
91559490|NCT03845517|183007339|SUPERIORITY||Risk Difference (RD)|5.2||||0.2189|TWO_SIDED|95.0|-7.9|18.3||One sided p-value.|Cochran-Mantel-Haenszel|||||18.3|-7.9|0.2189
91559491|NCT03845517|183007339|SUPERIORITY||Risk Difference (RD)|1.7||||0.401|TWO_SIDED|95.0|-11.8|15.3||One sided p-value.|Cochran-Mantel-Haenszel|||||15.3|-11.8|0.4010
91768693|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|8.5||||0.583|TWO_SIDED|95.0|-22.2|39.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.2|-22.2|0.583
91559492|NCT03845517|183007340|SUPERIORITY||Risk Difference (RD)|-2.1||||0.595|TWO_SIDED|95.0|-19.1|14.9||One sided p-value.|Cochran-Mantel-Haenszel|||||14.9|-19.1|0.5950
91559493|NCT03845517|183007340|SUPERIORITY||Risk Difference (RD)|8.6||||0.1125|TWO_SIDED|95.0|-5.3|22.6||One sided p-value.|Cochran-Mantel-Haenszel|||||22.6|-5.3|0.1125
91559494|NCT03845517|183007340|SUPERIORITY||Risk Difference (RD)|9.6||||0.0891|TWO_SIDED|95.0|-4.4|23.6||One sided p-value.|Cochran-Mantel-Haenszel|||||23.6|-4.4|0.0891
91559495|NCT01109979|183007361|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
91559496|NCT02580799|183007363|SUPERIORITY_OR_OTHER||||||=|0.137|TWO_SIDED||||||Chi-squared|||Site A: Site B variability assessment||||=0.137
91559497|NCT02580799|183007363|SUPERIORITY_OR_OTHER||||||=|0.454|TWO_SIDED||||||Chi-squared|||Site A: Site C variability assessment||||=0.454
91559498|NCT02580799|183007363|SUPERIORITY_OR_OTHER||||||=|0.211|TWO_SIDED||||||Chi-squared|||Site A: Site D variability assessment||||=0.211
91559499|NCT02580799|183007363|SUPERIORITY_OR_OTHER||||||=|0.294|TWO_SIDED||||||Chi-squared|||Site A: Site E variability assessment||||=0.294
91559500|NCT02580799|183007365|SUPERIORITY_OR_OTHER||||||=|0.054|TWO_SIDED||||||Chi-squared|||Site B: Site C variability assessment||||=0.054
91559501|NCT02580799|183007365|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Chi-squared|||Site B: Site D variability assessment||||=1.000
91559502|NCT02580799|183007365|SUPERIORITY_OR_OTHER||||||=|0.968|TWO_SIDED||||||Chi-squared|||Site B: Site E variability assessment||||=0.968
91559503|NCT02580799|183007378|SUPERIORITY_OR_OTHER||||||=|0.246|TWO_SIDED||||||Chi-squared|||Site C: Site D variability assessment||||=0.246
91559504|NCT02580799|183007378|SUPERIORITY_OR_OTHER||||||=|0.032|TWO_SIDED||||||Chi-squared|||Site C: Site E variability assessment||||=0.032
91559505|NCT02580799|183007378|SUPERIORITY_OR_OTHER||||||=|0.007|TWO_SIDED||||||Chi-squared|||Site D: Site E variability assessment||||=0.007
91559506|NCT02580799|183007380|SUPERIORITY_OR_OTHER||||||=|0.988|TWO_SIDED||||||Chi-squared|||Abroad: Site A variability assessment||||=0.988
91559507|NCT02580799|183007380|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Chi-squared|||Abroad: Site B variability assessment||||=0.008
91559508|NCT02580799|183007380|SUPERIORITY_OR_OTHER||||||=|0.031|TWO_SIDED||||||Chi-squared|||Abroad: Site C variability assessment||||=0.031
91559509|NCT02580799|183007380|SUPERIORITY_OR_OTHER||||||=|0.554|TWO_SIDED||||||Chi-squared|||Abroad: Site D variability assessment||||=0.554
91559510|NCT02580799|183007380|SUPERIORITY_OR_OTHER||||||=|0.709|TWO_SIDED||||||Chi-squared|||Abroad: Site E variability assessment||||=0.709
91559511|NCT03136861|183007385|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0264|TWO_SIDED|95.0|1.08|3.33|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||Average Spinal Pain Score \<4 at Week 8||3.33|1.08|0.0264
91559512|NCT03136861|183007385|SUPERIORITY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Total Spinal Pain Score \<4 at Week 8||3.10|0.95|0.0720
91559513|NCT03136861|183007385|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0043|TWO_SIDED|95.0|1.31|4.31|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Nocturnal Spinal Pain Score||4.31|1.31|0.0043
91559514|NCT03136861|183007386|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0466|TWO_SIDED|95.0|1.01|3.04|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||BASDAI Score \<4 at Week 8||3.04|1.01|0.0466
91559515|NCT01934452|183007387|SUPERIORITY||Hodges Lehmann estimator|2.8|||<|0.001|TWO_SIDED|95.0|2.2|3.8|||Wilcoxon (Mann-Whitney)|||||3.8|2.2|<0.001
91559516|NCT01934452|183007388|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
91559517|NCT01934452|183007389|SUPERIORITY|||||||1|||||||Fisher Exact|||Extended or partial nephrectomy||||1.000
91559518|NCT01934452|183007389|SUPERIORITY|||||||0.809|||||||Chi-squared|||Nephrectomy with or without adrenalectomy||||0.809
91768694|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|17.3||||0.171|TWO_SIDED|95.0|-7.2|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.9|-7.2|0.171
91768695|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
91768696|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
91768697|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.0|-13.4|1.000
91768698|NCT02365649|183425717|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
91768699|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
91768700|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
91768701|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
91768702|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|-6.3||||1|TWO_SIDED|95.0|-14.6|2.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.1|-14.6|1.000
91768703|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|2.6||||1|TWO_SIDED|95.0|-10.1|15.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.3|-10.1|1.000
91768704|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-11.8|16.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||16.7|-11.8|1.000
91768705|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
91768706|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
91559519|NCT01934452|183007389|SUPERIORITY|||||||0.019|||||||Chi-squared|||Nephrectomy with or without curettage||||0.019
91559520|NCT01934452|183007389|SUPERIORITY|||||||0.734|||||||Fisher Exact|||Open or laparoscopic nephrectomy||||0.734
91559521|NCT01934452|183007390|SUPERIORITY||Hodges Lehmann estimator|-3.7||||0.23|TWO_SIDED|95.0|-13.2|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-13.2|0.230
91559522|NCT01934452|183007391|SUPERIORITY|||||||0.695|||||||Fisher Exact|||Sarcomatoid contingent||||0.695
91559523|NCT01934452|183007392|SUPERIORITY|||||||0.316|||||||Chi-squared|||M class||||0.316
91559524|NCT01934452|183007393|SUPERIORITY||Hodges Lehmann estimator|-2.0||||0.778|TWO_SIDED|95.0|-22.0|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-22.0|0.778
91559525|NCT01934452|183007394|SUPERIORITY|||||||0.812|||||||Fisher Exact|||||||0.812
91559526|NCT01934452|183007395|SUPERIORITY||Odds Ratio (OR)|2.47||||0.077|TWO_SIDED|95.0|0.9|6.77|||Chi-squared|||Presence of necrosis||6.77|0.90|0.077
91559527|NCT01934452|183007395|SUPERIORITY||Odds Ratio (OR)|1.25||||0.673|TWO_SIDED|95.0|0.44|3.52|||Chi-squared|||Vascular embolism||3.52|0.44|0.673
91559528|NCT01934452|183007395|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.27|3.97|||Fisher Exact|||Sarcomatoid component||3.97|0.27|1.000
91559529|NCT01934452|183007396|SUPERIORITY||Hodges Lehmann estimator|-0.2||||0.865|TWO_SIDED|95.0|-1.5|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-1.5|0.865
91559530|NCT01934452|183007397|SUPERIORITY|||||||0.011|||||||Chi-squared|||Lung||||0.011
91559531|NCT01934452|183007397|SUPERIORITY|||||||0.132|||||||Chi-squared|||Bones||||0.132
91559532|NCT01934452|183007397|SUPERIORITY|||||||0.473|||||||Chi-squared|||Liver||||0.473
91559533|NCT01934452|183007397|SUPERIORITY|||||||0.101|||||||Fisher Exact|||Adrenal glands||||0.101
91559534|NCT01934452|183007397|SUPERIORITY|||||||0.445|||||||Fisher Exact|||Pancreas||||0.445
91559535|NCT01934452|183007397|SUPERIORITY|||||||0.04|||||||Chi-squared|||Lymph nodes||||0.040
91559536|NCT01934452|183007398|SUPERIORITY|||||||1|||||||Fisher Exact|||Supradiaphragmatic||||1.000
91559537|NCT01934452|183007398|SUPERIORITY|||||||0.295|||||||Fisher Exact|||Infradiaphragmatic||||0.295
91768707|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|4.3||||0.623|TWO_SIDED|95.0|-11.9|20.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||20.4|-11.9|0.623
91768708|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|1.000
91559538|NCT01934452|183007399|SUPERIORITY|||||||0.042|||||||Fisher Exact|||||||0.042
91559539|NCT01934452|183007400|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
91559540|NCT01934452|183007401|SUPERIORITY||Hodges Lehmann estimator|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|-1.0|||Wilcoxon (Mann-Whitney)|||||-1.0|-1.0|<0.001
91559541|NCT01934452|183007402|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
91559542|NCT03292692|183007454|SUPERIORITY||Slope|0.372|||<|0.001|TWO_SIDED|95.0|0.279|0.465|||Regression, Linear|Multi-level regression|Slope of intervention group compared to slope of the control group|||0.465|0.279|<0.001
91768709|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.7|-18.7|1.000
91559543|NCT03292692|183007455|SUPERIORITY||Slope|0.17|||<|0.001|TWO_SIDED|95.0|0.105|0.235|||Regression, Linear|Multilevel linear modeling|Slope of the intervention group compared to slope of the control group|||0.235|0.105|<0.001
91559544|NCT03292692|183007456|SUPERIORITY||Mean Difference (Final Values)|-2.149|||<|0.001|TWO_SIDED|95.0|-2.974|-1.324|||Regression, Linear|Multilevel linear regression|Multilevel linear modeling, with time modeled as change from pre-post.|||-1.324|-2.974|<0.001
91559545|NCT03292692|183007457|SUPERIORITY||Mean Difference (Final Values)|-1.144||||0.002|TWO_SIDED|95.0|-1.871|-0.417|||Regression, Linear||Multilevel linear modeling, with time modeled as change from pre to post.|||-0.417|-1.871|0.002
91559546|NCT05640167|183007461|OTHER|||||||0.015|||||||t-test, 2 sided|Degrees of freedom 17||||||0.015
91559547|NCT05640167|183007462|OTHER|||||||0.114||||||Positive p = 0.114 Health-directed p = 0.028 Skill and Technique p = 0.013 Constructive attitudes p = 0.003 Self-monitoring \& insight p = 0.001 Health service navigation p = 0.077 Social Integration p = 0.126 Emotional well-being p = 0.093|t-test, 2 sided|||||||0.114
91559548|NCT05640167|183007463|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
91559549|NCT05640167|183007464|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
91559550|NCT05640167|183007465|OTHER|||||||0.309|||||||t-test, 2 sided|||||||0.309
91559551|NCT05640167|183007466|OTHER|||||||0.827|||||||t-test, 2 sided|||||||0.827
91559552|NCT00286325|183007479|SUPERIORITY_OR_OTHER||||||=|0.0156||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon comparing week zero antibody value in units to week 24 antibody value in units||||=0.0156
91559553|NCT00286325|183007480|SUPERIORITY_OR_OTHER||||||=|0.0078|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of B cell number at week 0 to b cell number in participants at week 24||||=0.0078
91559554|NCT00210236|183007488|EQUIVALENCE|The two groups will be considered equivalent if the 5-year survival rate for group B (without lymph node dissection) is not less than 92%. This corresponds to hazard ratio (HR) of less than 1.6.|Hazard Ratio (HR)|3.067||||0.013|TWO_SIDED|95.0|1.4|6.7|||Log Rank|||||6.7|1.4|0.013
91559555|NCT03854734|183007560|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|1.0|1.25|||Regression, Logistic|||Analysis for vaccine intention of Tdap||1.25|1.00|
91559556|NCT03854734|183007560|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|1.0|1.29|||Regression, Logistic|||Analysis for vaccine intention of MCV||1.29|1.00|
91559557|NCT03854734|183007560|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Regression, Logistic|||Analysis for vaccine intention of HPV||1.14|0.96|
91559558|NCT00264576|183007562|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.04|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.04|0.70|
91559559|NCT00264576|183007562|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.46|0.7|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.70|0.46|
91559560|NCT00264576|183007562|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.95|1.36|||ANOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.36|0.95|
91559561|NCT00264576|183007562|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
91559562|NCT00264576|183007562|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.5|0.75|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.75|0.50|
91559563|NCT00264576|183007562|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|1.31|||||TWO_SIDED|95.0|1.09|1.57|||ANOVA|||"The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.57|1.09|
91559564|NCT00264576|183007568|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.03|||ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.03|0.70|
91559565|NCT00264576|183007568|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.52|0.76|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.76|0.52|
91768710|NCT02365649|183425718|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|0.501
91768711|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
91768712|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
91559566|NCT00264576|183007568|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.16|||||TWO_SIDED|95.0|0.98|1.38|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.38|0.98|
91559567|NCT00264576|183007568|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12||To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
91559568|NCT00264576|183007568|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.57|0.83|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.83|0.57|
91559569|NCT00264576|183007568|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.33|||||TWO_SIDED|95.0|1.13|1.58|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.58|1.13|
91559570|NCT00569166|183007633|SUPERIORITY_OR_OTHER|||||||0.3679||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.3679
91559571|NCT00569166|183007633|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.4715
91559572|NCT01853384|183007642|SUPERIORITY_OR_OTHER|||||||0.5348||||||Analysis adjusted for sites, with significance being at P \< 0.05|Cochran-Mantel-Haenszel|||||||.5348
91559573|NCT01853384|183007643|SUPERIORITY_OR_OTHER|||||||0.9456|||||||Regression, Cox|||||||.9456
91559574|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.6194||||||Treatment Week 01|Cochran-Mantel-Haenszel|||||||.6194
91559575|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.793||||||Treatment Week 02|Cochran-Mantel-Haenszel|||||||.7930
91559576|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.3362||||||Treatment Week 03|Cochran-Mantel-Haenszel|||||||0.3362
91559577|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment Week 04|Cochran-Mantel-Haenszel|||||||0.5263
91559578|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.1997||||||Treatment Week 05|Cochran-Mantel-Haenszel|||||||0.1997
91559579|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.1617||||||Treatment Week 06|Cochran-Mantel-Haenszel|||||||0.1617
91559580|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.2611||||||Treatment Week 07|Cochran-Mantel-Haenszel|||||||0.2611
91559581|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.7232||||||Treatment Week 08|Cochran-Mantel-Haenszel|||||||0.7232
91559582|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.4405||||||Treatment Week 09|Cochran-Mantel-Haenszel|||||||0.4405
91559583|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.3516||||||Treatment Week 10|Cochran-Mantel-Haenszel|||||||0.3516
91559584|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.2821||||||Treatment Week 11|Cochran-Mantel-Haenszel|||||||0.2821
91559585|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.3722||||||Treatment Week 12|Cochran-Mantel-Haenszel|||||||0.3722
91559586|NCT01853384|183007645|SUPERIORITY_OR_OTHER|||||||0.5348||||||Week 12 - Primary Endpoint|Cochran-Mantel-Haenszel|||||||0.5348
91559587|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.5909||||||Week 01|ANCOVA|||||||0.5909
91559588|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.8234||||||Week 02|ANCOVA|||||||0.8234
91559589|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.1556||||||Week 03|ANCOVA|||||||0.1556
91559590|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.3487||||||Week 04|ANCOVA|||||||0.3487
91559591|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.1064||||||Week 05|ANCOVA|||||||0.1064
91559592|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.2888||||||Week 06|ANCOVA|||||||0.2888
91559593|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.6095||||||Week 07|ANCOVA|||||||0.6095
91559594|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.1566||||||Week 08|ANCOVA|||||||0.1566
91559595|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.4216||||||Week 09|ANCOVA|||||||0.4216
91559596|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.8166||||||Week10|ANCOVA|||||||0.8166
91559597|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.9114||||||Week 11|ANCOVA|||||||0.9114
91559598|NCT01853384|183007647|SUPERIORITY_OR_OTHER|||||||0.9733||||||Week 12|ANCOVA|||||||0.9733
91559599|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.7439||||||Week 01|ANCOVA|||||||0.7439
91559600|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.6992||||||Week 02|ANCOVA|||||||0.6992
91559601|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.0867||||||Week 03|ANCOVA|||||||0.0867
91559602|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.5739||||||Week 04|ANCOVA|||||||0.5739
91559603|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.6497||||||Week 05|ANCOVA|||||||0.6497
91559604|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.1427||||||Week 06|ANCOVA|||||||0.1427
91559605|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.0682||||||Week 07|ANCOVA|||||||0.0682
91559606|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.0161||||||Week 08|ANCOVA|||||||0.0161
91559607|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.0973||||||Week 09|ANCOVA|||||||0.0973
91559608|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.4661||||||Week 10|ANCOVA|||||||0.4661
91559609|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.601||||||Week 11|ANCOVA|||||||0.6010
91559610|NCT01853384|183007648|SUPERIORITY_OR_OTHER|||||||0.3369||||||Week 12|ANCOVA|||||||0.3369
91559611|NCT00486954|183007660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2088|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||||1.11|0.64|0.2088
91559612|NCT00949234|183007732|OTHER||||||<|0.05|||||||Chi-squared|||There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.||||<0.05
91559613|NCT00508183|183007733|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
91559614|NCT00508183|183007734|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91559615|NCT00508183|183007735|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91559616|NCT00508183|183007737|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
91559617|NCT03785756|183007738|EQUIVALENCE|The primary analysis was based on a two-sided test at the significance level of 0.05. The treatment difference is presented with a 95% confidence interval (CI).|Mean Difference (Final Values)|34.05|||<|0.0001|TWO_SIDED|95.0|26.72|41.38|||ANCOVA|Estimates from an ANCOVA model with SPID12 score as the dependent variable. Terms for treatment and baseline pain score were included as covariates.||The primary efficacy hypothesis was that SPID12 for placebo was equal to SPID12 for ibuprofen 2 × 300 mg PR tablets.||41.38|26.72|<0.0001
91559618|NCT02291861|183007786|SUPERIORITY||LSM difference|-1.9||||0.001|TWO_SIDED|95.0|-3.09|-0.79||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~The primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group."||-0.79|-3.09|0.001
91559619|NCT02291861|183007786|SUPERIORITY||LSM difference|-1.8||||0.003|TWO_SIDED|95.0|-3.0|-0.63||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence."||-0.63|-3.00|0.003
91559620|NCT02291861|183007786|SUPERIORITY||LSM difference|-0.7||||0.217|TWO_SIDED|95.0|-1.84|0.42||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence."||0.42|-1.84|0.217
91559621|NCT02291861|183007787|SUPERIORITY||Odds Ratio (OR)|2.11||||0.059|TWO_SIDED|95.0|0.96|4.645|||Cochran-Mantel-Haenszel|The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence."||4.645|0.960|0.059
91559622|NCT02291861|183007787|SUPERIORITY||Odds Ratio (OR)|2.71||||0.014|TWO_SIDED|95.0|1.211|6.052|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence."||6.052|1.211|0.014
91559623|NCT02291861|183007787|SUPERIORITY||Odds Ratio (OR)|1.15||||0.734|TWO_SIDED|95.0|0.509|2.61|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence."||2.610|0.509|0.734
91559624|NCT02291861|183007788|SUPERIORITY||LSM difference|-3.6||||0.207|TWO_SIDED|95.0|-9.18|2.0||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.00|-9.18|0.207
91559625|NCT02291861|183007788|SUPERIORITY||LSM difference|-3.1||||0.281|TWO_SIDED|95.0|-8.86|2.59||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.59|-8.86|0.281
91559626|NCT02291861|183007788|SUPERIORITY||LSM difference|1.3||||0.627|TWO_SIDED|95.0|-4.1|6.79||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||6.79|-4.10|0.627
91559627|NCT02291861|183007789|SUPERIORITY||Odds Ratio (OR)|1.51||||0.296|TWO_SIDED|95.0|0.694|3.285||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.285|0.694|0.296
91768713|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
91768714|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|-3.1||||1|TWO_SIDED|95.0|-9.2|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.9|-9.2|1.000
91768715|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
91768716|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-9.1|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||11.5|-9.1|1.000
91768717|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
91768718|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
91768719|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-14.1|12.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||12.1|-14.1|1.000
91768720|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
91768721|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
91768722|NCT02365649|183425719|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
91768723|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|15.0||||0.669|TWO_SIDED|95.0|-21.9|51.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||51.9|-21.9|0.669
91768724|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|15.0||||0.343|TWO_SIDED|95.0|-15.2|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||45.2|-15.2|0.343
91768725|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||17.2|-57.2|0.442
91768726|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-23.4|32.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||32.2|-23.4|1.000
91768727|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|5.0||||0.601|TWO_SIDED|95.0|-13.6|23.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.5|-13.6|0.601
91768728|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|1.8||||1|TWO_SIDED|95.0|-18.2|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.7|-18.2|1.000
91559628|NCT02291861|183007789|SUPERIORITY||Odds Ratio (OR)|1.82||||0.134|TWO_SIDED|95.0|0.826|3.994||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.994|0.826|0.134
91559629|NCT02291861|183007789|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.302|1.563||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||1.563|0.302|0.372
91559630|NCT02291861|183007790|SUPERIORITY||Odds Ratio (OR)|3.8||||0.007|TWO_SIDED|95.0|1.395|10.359||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.359|1.395|0.007
91559631|NCT02291861|183007790|SUPERIORITY||Odds Ratio (OR)|3.96||||0.005|TWO_SIDED|95.0|1.46|10.716||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.716|1.460|0.005
91559632|NCT02291861|183007790|SUPERIORITY||Odds Ratio (OR)|1.13||||0.829|TWO_SIDED|95.0|0.383|3.316||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.316|0.383|0.829
91559633|NCT02291861|183007791|SUPERIORITY||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.44|-9.52||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-9.52|-33.44|<0.001
91559634|NCT02291861|183007791|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.001|TWO_SIDED|95.0|-32.57|-7.92||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-7.92|-32.57|0.001
91559635|NCT02291861|183007791|SUPERIORITY||Mean Difference (Final Values)|-8.4||||0.16|TWO_SIDED|95.0|-20.15|3.34||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||3.34|-20.15|0.160
91559636|NCT02336958|183007795|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
91559637|NCT02336958|183007796|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||t-test, 2 sided|||||||0.459
91768729|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|16.5||||0.301|TWO_SIDED|95.0|-14.5|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||47.5|-14.5|0.301
91768730|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.4|-10.3|0.256
91768731|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|1.5||||0.917|TWO_SIDED|95.0|-26.5|29.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.5|-26.5|0.917
91768732|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|-20.2||||1|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|1.000
91559638|NCT03547154|183007797|SUPERIORITY_OR_OTHER|||||||0.322||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||0.322
91559639|NCT03547154|183007798|SUPERIORITY_OR_OTHER||||||>|0.999||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||>0.999
91559640|NCT03547154|183007799|SUPERIORITY_OR_OTHER|||||||0.588||||||Analysis of Complete Response|Fisher Exact|Missing data considered failures||||||0.588
91559641|NCT03547154|183007800|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.859|||||TWO_SIDED|95.0|0.429|1.721|||||Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox's proportional hazards model.|||1.721|0.429|
91559642|NCT01328756|183007861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.||||< 0.001
91559643|NCT00257309|183007865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.21|TWO_SIDED|95.0|0.38|1.23||Unadjusted analysis|Chi-squared|||||1.23|0.38|0.21
91559644|NCT00849485|183007866|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|98.0||||||90.0|94.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.5|
91559645|NCT00849485|183007867|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|99.9||||||90.0|97.6|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|97.6|
91559646|NCT00849485|183007868|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|98.1|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|98.1|
91559647|NCT00186446|183007869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|t(19)= -8.93||||||<.001
91559648|NCT00556478|183007874|SUPERIORITY_OR_OTHER||Ratio (over 3 months/Baseline)|3.05|||<|0.0001|TWO_SIDED|95.0|2.29|4.06|||ANCOVA|||||4.06|2.29|<0.0001
91559649|NCT00556478|183007875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.0001|TWO_SIDED|95.0|3.61|6.34|||ANCOVA|||Analysis of IPE domain ejaculatory control||6.34|3.61|<0.0001
91559650|NCT00556478|183007875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.84|||ANCOVA|||IPE domain sexual satisfaction||5.84|3.30|<0.0001
91559651|NCT00556478|183007875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.86|3.2|||ANCOVA|||IPE domain distress||3.20|1.86|<0.0001
91559652|NCT02233998|183007905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0162|<|0.001|TWO_SIDED|95.0|-0.266|-0.202||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.202|-0.266|<0.001
91559653|NCT02233998|183007905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.197|STANDARD_ERROR_OF_MEAN|0.0161|<|0.001|TWO_SIDED|95.0|-0.228|-0.165||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.165|-0.228|<0.001
91768733|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|-5.7||||0.697|TWO_SIDED|95.0|-28.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.3|-28.8|0.697
91559654|NCT02233998|183007906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.469|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.526|-0.413||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.413|-0.526|<0.001
91559655|NCT02233998|183007906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.379|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.435|-0.322||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.322|-0.435|<0.001
91559656|NCT02233998|183007907|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.006|<|0.001|TWO_SIDED|95.0|-0.042|-0.019||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.019|-0.042|<0.001
91768734|NCT02365649|183425720|SUPERIORITY||Risk Difference (RD)|-20.0||||0.126|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|0.126
91768735|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|10.0||||0.691|TWO_SIDED|95.0|-30.8|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.8|-30.8|0.691
91559657|NCT02233998|183007907|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.026|STANDARD_ERROR_OF_MEAN|0.0059|<|0.001|TWO_SIDED|95.0|-0.038|-0.014||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.014|-0.038|<0.001
91559658|NCT02233998|183007908|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.24|||<|0.001|TWO_SIDED|95.0|20.75|25.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||25.85|20.75|<0.001
91559659|NCT02233998|183007908|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.444|||<|0.001|TWO_SIDED|95.0|17.09|22.22||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||22.22|17.09|<0.001
91559660|NCT02233998|183007909|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
91559661|NCT02233998|183007909|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
91559662|NCT02233998|183007910|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|2.05|||<|0.001|TWO_SIDED|95.0|1.3|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|1.30|<0.001
91559663|NCT02233998|183007910|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.19|||<|0.001|TWO_SIDED|95.0|0.93|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.06|0.93|<0.001
91559664|NCT02233998|183007911|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.316||||0.016|TWO_SIDED|95.0|0.0|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|0.00|0.016
91559665|NCT02233998|183007911|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|0.926||||0.197|TWO_SIDED|95.0|-0.16|1.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||1.85|-0.16|0.197
91559666|NCT02233998|183007912|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.214|||<|0.001|TWO_SIDED|95.0|18.21|28.77||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||28.77|18.21|<0.001
91559667|NCT02233998|183007912|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|18.59|||<|0.001|TWO_SIDED|95.0|13.69|23.81||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||23.81|13.69|<0.001
91559668|NCT02233998|183007913|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
91559669|NCT02233998|183007913|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
91559670|NCT01262456|183007921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001|TWO_SIDED|95.0|-0.61|-0.22||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.22|-0.61|<0.0001
91559671|NCT01262456|183007921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0003|TWO_SIDED|95.0|-0.57|-0.17||A priori threshold for significance was p\<=0.05|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.17|-0.57|0.0003
91559672|NCT01262456|183007922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.38|3.03||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||3.03|1.38|0.0004
91559673|NCT01262456|183007922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0009|TWO_SIDED|95.0|1.32|2.96||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||2.96|1.32|0.0009
91559674|NCT01262456|183007923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0029|TWO_SIDED|95.0|-0.57|-0.12||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.12|-0.57|0.0029
91559675|NCT01262456|183007923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0128|TWO_SIDED|95.0|-0.52|-0.06||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.06|-0.52|0.0128
91559676|NCT01262456|183007924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0233|TWO_SIDED|95.0|1.08|3.02||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||3.02|1.08|0.0233
91559677|NCT01262456|183007924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0386|TWO_SIDED|95.0|1.03|2.87||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||2.87|1.03|0.0386
91559678|NCT01262456|183007925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.76||||0.0026|TWO_SIDED|95.0|15.02|70.51||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||70.51|15.02|0.0026
91559679|NCT01262456|183007925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.95||||0.0064|TWO_SIDED|95.0|11.03|66.88||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||66.88|11.03|0.0064
91559680|NCT01262456|183007926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-86.17||||0.0034|TWO_SIDED|95.0|-143.69|-28.64||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-28.64|-143.69|0.0034
91559681|NCT01262456|183007926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.8||||0.0086|TWO_SIDED|95.0|-135.7|-19.89||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-19.89|-135.70|0.0086
91559682|NCT01262456|183007927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.31||||0.4126|TWO_SIDED|95.0|-153.94|63.32||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||63.32|-153.94|0.4126
91559683|NCT01262456|183007927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.79||||0.7353|TWO_SIDED|95.0|-127.99|90.41||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||90.41|-127.99|0.7353
91768736|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||60.0|-2.5|0.086
91768737|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||25.6|-45.6|0.702
91559684|NCT01213940|183007980|EQUIVALENCE|95% confidence limit from standard deviation of mean|||||<|0.05|||||||ANOVA|||one -way ANOVA was used for the analysis||||<0.05
91559685|NCT03242863|183007996|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91559686|NCT03242863|183007997|SUPERIORITY|||||||0.0015|||||||Mixed Models Analysis|||||||0.0015
91559687|NCT03242863|183007998|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91559688|NCT03242863|183007999|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91559689|NCT03786471|183008023|SUPERIORITY||marginal difference of LS means|0.3||||0.33|TWO_SIDED|97.5|-0.18|0.78||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.78|-0.18|0.33
91768738|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|-12.5||||0.557|TWO_SIDED|95.0|-24.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||-1.0|-24.0|0.557
91768739|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
91768740|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.2|-14.4|0.707
91559690|NCT03786471|183008023|SUPERIORITY||marginal difference of LS means|-0.62||||0.33|TWO_SIDED|97.5|-1.61|0.37||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.37|-1.61|0.33
91768741|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-27.9|28.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.8|-27.9|1.000
91768742|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|16.7||||0.175|TWO_SIDED|95.0|-7.2|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||40.6|-7.2|0.175
91768743|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|8.7||||0.517|TWO_SIDED|95.0|-18.0|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.4|-18.0|0.517
91559691|NCT03786471|183008023|SUPERIORITY||marginal difference of LS means|-0.33||||0.46|TWO_SIDED|97.5|-1.32|0.67||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.67|-1.32|0.46
91559692|NCT03786471|183008030|SUPERIORITY||marginal difference of LS means|0.25||||0.54|TWO_SIDED|97.5|-0.16|0.66||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.66|-0.16|0.54
91559693|NCT03786471|183008030|SUPERIORITY||marginal difference of LS means|-0.1||||0.79|TWO_SIDED|97.5|-0.94|0.74||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.74|-0.94|0.79
91559694|NCT03786471|183008030|SUPERIORITY||marginal difference of LS means|0.14||||0.79|TWO_SIDED|97.5|-0.7|0.99||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.99|-0.70|0.79
91559695|NCT03786471|183008037|SUPERIORITY||marginal difference of LS means|0.52||||0.48|TWO_SIDED|95.0|-0.09|1.13||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.13|-.09|0.48
91559696|NCT03786471|183008037|SUPERIORITY||marginal difference of LS means|-0.81||||0.62|TWO_SIDED|95.0|-2.07|0.45||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||0.45|-2.07|0.62
91559697|NCT03786471|183008037|SUPERIORITY||marginal difference of LS means|-1.33||||0.23|TWO_SIDED|95.0|-2.58|-0.07||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||-0.07|-2.58|0.23
91559698|NCT03786471|183008044|SUPERIORITY||marginal difference of LS means|0.28||||0.23|TWO_SIDED|95.0|0.01|0.54||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||.54|.01|0.23
91559699|NCT03786471|183008044|SUPERIORITY||marginal difference of LS means|0.01||||0.98|TWO_SIDED|95.0|-0.53|0.55||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||.55|-.53|.98
91559700|NCT03786471|183008044|SUPERIORITY||marginal difference of LS means|-0.27||||0.65|TWO_SIDED|95.0|-0.81|0.27||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.27|-0.81|0.65
91559701|NCT03786471|183008049|SUPERIORITY||marginal difference of LS means|-0.16||||0.62|TWO_SIDED|95.0|-0.37|0.06||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.06|-0.37|0.62
91559702|NCT03786471|183008049|SUPERIORITY||marginal difference of LS means|0.7||||0.01|TWO_SIDED|95.0|0.26|1.14||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.14|0.26|0.01
91559703|NCT03786471|183008049|SUPERIORITY||marginal difference of LS means|0.85||||0.001|TWO_SIDED|95.0|0.42|1.29||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.29|0.42|0.001
91559704|NCT03346200|183008072|NON_INFERIORITY|The non-inferiority margin was based on the proportion of responders and was set to 17%. That is, we defined non-inferiority to mean that the proportion of responders in the non-referent study arms is not less than one third of the responders in the 20 mg group (50% minus 33% = 17%)|Median Difference (Final Values)|52.5|||<|0.01|TWO_SIDED|97.5|41.9|100.0|||one-sided Wald tests|P-values were corrected for multiple comparisons using the Holm-Bonferroni method. Non-inferiority p-values were declared if less than a=0.025||||100|41.9|<0.01
91559705|NCT01513447|183008080|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
91559706|NCT01513447|183008081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.0||||0.29|TWO_SIDED|95.0|-230.0|171.0|||Wilcoxon (Mann-Whitney)|||||171|-230|0.29
91559707|NCT03141177|183008082|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.64|||Stratified Log-Rank|||||0.64|0.41|<0.0001
91559708|NCT03141177|183008083|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.6||||0.001|TWO_SIDED|98.89|0.4|0.89|||Stratified Log-Rank|||||0.89|0.40|0.0010
91559709|NCT03141177|183008084|SUPERIORITY|Treatment A over Treatment C|Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.51|4.95|||Stratified Cochran-Mantel-Haenszel|||||4.95|2.51|<0.0001
91768744|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
91768745|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
91768746|NCT02365649|183425721|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
91768747|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-41.0|41.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||41.0|-41.0|1.000
91768748|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
91559710|NCT03141177|183008084|OTHER|Treatment A - Treatment C|Difference of Objective Response Rates|28.6|||||TWO_SIDED|95.0|21.7|35.6|||||Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.|||35.6|21.7|
91559711|NCT00092456|183008096|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
91559712|NCT00092456|183008096|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
91559713|NCT00092456|183008096|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANCOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
91559714|NCT02489799|183008125|EQUIVALENCE|The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05).|Incidence Rate Ratio|1.06||||0.545|TWO_SIDED|95.0|0.87|1.3|||Poisson model using GEE|We fit a Poisson model using generalized estimating equations. No adjustments were made for degrees of freedom.|The incidence rate ratio compares intervention to control.|We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).||1.30|0.87|0.545
91559715|NCT02753075|183008178|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.09||||0.829|TWO_SIDED|95.0|-0.289|0.461||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.461|-0.289|0.8290
91559716|NCT02753075|183008178|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.9993|TWO_SIDED|95.0|-0.372|0.362||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.362|-0.372|0.9993
91559717|NCT02753075|183008179|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.5892|TWO_SIDED|95.0|-0.242|0.424|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.424|-0.242|0.5892
91559718|NCT02753075|183008180|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.2825|TWO_SIDED|95.0|-0.116|0.396|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.396|-0.116|0.2825
91768749|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||15.9|-55.9|0.440
91768750|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-24.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||19.3|-24.3|1.000
91768751|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
91768752|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.9|-55.9|0.440
91768753|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-28.7|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-28.7|1.000
91768754|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.9|-14.0|0.404
91768755|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
91559719|NCT02753075|183008180|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8448|TWO_SIDED|95.0|-0.229|0.28|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.280|-0.229|0.8448
91559720|NCT02753075|183008180|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.3784|TWO_SIDED|95.0|-0.141|0.371|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.371|-0.141|0.3784
91559721|NCT02753075|183008181|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1688|TWO_SIDED|95.0|-10.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-10.00|0.1688
91559722|NCT02753075|183008181|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.438|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.4380
91559723|NCT02753075|183008181|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5693|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.5693
91559724|NCT02753075|183008182|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7789|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7789
91559725|NCT02753075|183008182|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7214|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7214
91559726|NCT02753075|183008182|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.896|TWO_SIDED|95.0|-5.0|5.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|-5.000|0.8960
91559727|NCT02753075|183008183|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.0978|TWO_SIDED|95.0|-0.084|0.987|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.987|-0.084|0.0978
91559728|NCT02753075|183008183|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.4607|TWO_SIDED|95.0|-0.333|0.732|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.732|-0.333|0.4607
91559729|NCT02753075|183008183|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.3542|TWO_SIDED|95.0|-0.283|0.787|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.787|-0.283|0.3542
91559730|NCT02753075|183008184|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.9474|TWO_SIDED|95.0|-0.665|0.711|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.711|-0.665|0.9474
91559731|NCT02753075|183008184|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.7987|TWO_SIDED|95.0|-0.76|0.586|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.586|-0.760|0.7987
91559732|NCT02753075|183008184|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.7525|TWO_SIDED|95.0|-0.578|0.798|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.798|-0.578|0.7525
91559733|NCT01215253|183008212|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Regression, Cox|||||1.05|0.67|0.117
91559734|NCT01215253|183008213|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.891|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox|||||1.26|0.76|0.891
91559735|NCT01215253|183008214|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.028|TWO_SIDED|95.0|0.51|0.96|||Anderson-Gill analysis|||||0.96|0.51|0.028
91559736|NCT01215253|183008215|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.398|TWO_SIDED|95.0|0.38|1.47|||Regression, Cox|||||1.47|0.38|0.398
91559737|NCT01215253|183008216|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.316|TWO_SIDED|95.0|0.91|1.34|||Regression, Cox|||||1.34|0.91|0.316
91559738|NCT01215253|183008217|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.577|TWO_SIDED|95.0|0.84|1.37|||Regression, Cox|||||1.37|0.84|0.577
91559739|NCT01215253|183008218|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.871|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.871
91559740|NCT01215253|183008219|SUPERIORITY|||||||0.508|||||||nonparametric Wilcoxon rank-sum test|||||||0.508
91559741|NCT01215253|183008220|SUPERIORITY|||||||0.948|||||||nonparametric Wilcoxon rank-sum test|||||||0.948
91559742|NCT01215253|183008221|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.038|TWO_SIDED|95.0|0.55|0.98|||Regression, Cox|||||0.98|0.55|0.038
91559743|NCT01215253|183008222|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.947|TWO_SIDED|95.0|0.73|1.41|||Regression, Cox|||||1.41|0.73|0.947
91559744|NCT01215253|183008223|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.414|TWO_SIDED|95.0|0.36|1.52|||Anderdon-Gill analysis|||||1.52|0.36|0.414
91559745|NCT00080119|183008224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.67|1.44||Threshold p-value for significance = 0.0492|Log Rank||Hazard ratio for INH relative to Placebo|||1.44|0.67|0.93
91559746|NCT00080119|183008225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.55|1.3||Threshold p-value for significance = 0.0493|Log Rank||Hazard ratio for INH relative to Placebo|||1.30|0.55|0.43
91559747|NCT04332991|183008256|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.73|1.42|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group.|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.42|0.73|
91559748|NCT04332991|183008257|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.9|1.81|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.81|0.90|
91559749|NCT04332991|183008258|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.84|
91559750|NCT04332991|183008259|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.38|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure is adjusted for : age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.38|0.69|
91559751|NCT04332991|183008260|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.68|3.57|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.57|0.68|
91559752|NCT04332991|183008261|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.54|2.09|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.09|0.54|
91768756|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
91768757|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
91559753|NCT04332991|183008262|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.6|2.14|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.14|0.60|
91559754|NCT04332991|183008263|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.68|1.34|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.34|0.68|
91559755|NCT04332991|183008264|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.76|2.08|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.08|0.76|
91768758|NCT02365649|183425722|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
91768759|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|10.0||||0.606|TWO_SIDED|95.0|-23.8|43.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||43.8|-23.8|0.606
91768760|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|35.0||||0.034|TWO_SIDED|95.0|5.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||64.1|5.9|0.034
91559756|NCT04332991|183008265|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.61|1.72|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.72|0.61|
91559757|NCT04332991|183008266|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.88|0.84|
91559758|NCT04332991|183008267|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.85|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.85|
91559759|NCT04332991|183008268|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||||1.8|-1.0|
91559760|NCT04332991|183008269|SUPERIORITY||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.61|3.02|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.02|0.61|
91559761|NCT04332991|183008270|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
91559762|NCT04332991|183008271|SUPERIORITY||Odds Ratio (OR)|2.51|||||TWO_SIDED|95.0|0.78|8.12|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||8.12|0.78|
91559763|NCT04332991|183008272|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.05|0.45|
91559764|NCT04332991|183008273|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
91559765|NCT04332991|183008274|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.59|1.59|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.59|0.59|
91768761|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|-15.0||||0.532|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||0.6|-30.6|0.532
91559766|NCT04332991|183008275|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.3|1.58|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.58|0.30|
91559767|NCT04332991|183008276|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.48|3.18|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.18|0.48|
91559768|NCT04332991|183008277|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.24|3.96|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.96|0.24|
91559769|NCT04332991|183008278|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.73|1.53|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.53|0.73|
91559770|NCT04332991|183008279|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.92|1.89|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.89|0.92|
91768762|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.8|-20.5|1.000
91768763|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||13.3|-14.4|1.000
91559771|NCT04332991|183008280|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.21|2.94|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.94|0.21|
91559772|NCT04332991|183008281|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.06|15.74|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||15.74|0.06|
91559773|NCT04332991|183008282|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.35|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.35|0.69|
91559774|NCT01762982|183008301|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0654||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0654
91559775|NCT01762982|183008304|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0078||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0078
91559776|NCT01762982|183008305|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0547||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0547
91559777|NCT03692871|183008355|OTHER||Difference in Percentage|7.9|||=|0.003|TWO_SIDED|95.0|2.8|12.8|||Miettinen & Nurminen method|||Injection-site erythema||12.8|2.8|= 0.003
91559778|NCT03692871|183008355|OTHER||Difference in Percentage|-0.3|||=|0.882|TWO_SIDED|95.0|-5.0|4.0|||Miettinen & Nurminen method|||Injection-site induration||4.0|-5.0|= 0.882
91559779|NCT03692871|183008355|OTHER||Difference in Percentage|6.4|||=|0.014|TWO_SIDED|95.0|1.3|11.3|||Miettinen & Nurminen method|||Injection-site pain||11.3|1.3|= 0.014
91559780|NCT03692871|183008355|OTHER||Difference in Percentage|4.6|||=|0.051|TWO_SIDED|95.0|0.0|8.9|||Miettinen & Nurminen method|||Injection-site swelling||8.9|0.0|= 0.051
91559781|NCT03692871|183008356|OTHER||Difference in Percentage|5.5|||=|0.033|TWO_SIDED|95.0|0.4|10.5|||Miettinen & Nurminen method|||Decreased appetite||10.5|0.4|= 0.033
91559782|NCT03692871|183008356|OTHER||Difference in Percentage|5.6|||=|0.016|TWO_SIDED|95.0|1.0|10.5|||Miettinen & Nurminen method|||Irritability||10.5|1.0|= 0.016
91559783|NCT03692871|183008356|OTHER||Difference in Percentage|0.4|||=|0.878|TWO_SIDED|95.0|-4.7|5.6|||Miettinen & Nurminen method|||Somnolence||5.6|-4.7|= 0.878
91559784|NCT03692871|183008356|OTHER||Difference in Percentage|-0.8|||=|0.503|TWO_SIDED|95.0|-3.8|1.5|||Miettinen & Nurminen method|||Urticaria||1.5|-3.8|= 0.503
91559785|NCT03692871|183008357|OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-0.8|0.4||||||Percentage of participants with a vaccine-related SAE||0.4|-0.8|
91559786|NCT00257894|183008369|SUPERIORITY_OR_OTHER|||||||0.57||||||Effect size close to zero (eta squared of .01)|ANOVA|Interaction effect term from group by time ANOVA||||||.57
91559787|NCT00257894|183008370|SUPERIORITY_OR_OTHER|||||||0.6||||||Effect size about zero (eta squared = .01)|ANOVA|Interaction term from a group by time ANOVA||||||.60
91559788|NCT00257894|183008371|SUPERIORITY_OR_OTHER|||||||0.79||||||Effect size (eta squared) = 0|ANOVA|Interaction term of a group by time ANOVA||||||.79
91559789|NCT00257894|183008372|SUPERIORITY_OR_OTHER|||||||0.21||||||For test of drug by time interaction effect|ANOVA|Medium effect size, eta squared = .061||Analysis of variance, group by time (Day 0 vs. Day 10).||||.21
91559790|NCT02852824|183008375|OTHER||Slope|0.9058|STANDARD_ERROR_OF_MEAN|0.0523|||TWO_SIDED|95.0|0.7973|1.0142||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used a statistical method.||1.0142|0.7973|
91559791|NCT02852824|183008376|OTHER||Slope|0.9528|STANDARD_ERROR_OF_MEAN|0.0454|||TWO_SIDED|95.0|0.8581|1.0475||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0475|0.8581|
91559792|NCT02852824|183008377|OTHER||Slope|0.9439|STANDARD_ERROR_OF_MEAN|0.0358|||TWO_SIDED|95.0|0.8697|1.0182||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0182|0.8697|
91559793|NCT02852824|183008378|OTHER||Slope|0.9708|STANDARD_ERROR_OF_MEAN|0.0351|||TWO_SIDED|95.0|0.8975|1.044||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0440|0.8975|
91559794|NCT01316913|183008379|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.377|TWO_SIDED|95.0|-0.027|0.072|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.|||0.072|-0.027|0.377
91768764|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.0|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.6|-16.0|1.000
91768765|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|12.1||||0.35|TWO_SIDED|95.0|-11.7|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.8|-11.7|0.350
91559795|NCT01316913|183008379|SUPERIORITY_OR_OTHER||Least squares mean difference|0.06||||0.018|TWO_SIDED|95.0|0.01|0.109||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.109|0.010|0.018
91559796|NCT01316913|183008379|SUPERIORITY_OR_OTHER||Least squares mean difference|0.037||||0.142|TWO_SIDED|95.0|-0.012|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.087|-0.012|0.142
91559797|NCT01316913|183008379|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.003|TWO_SIDED|95.0|0.025|0.123|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.123|0.025|0.003
91559798|NCT01860079|183008382|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared, Corrected|||Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.||||<0.05
91559799|NCT02102724|183008383|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen's d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.|The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.|||< 0.05
91559800|NCT04821271|183008384|OTHER|Treatment comparison||||||0.91|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.91
91559801|NCT04821271|183008385|OTHER|Treatment comparison||||||0.47|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.47
91559802|NCT04821271|183008386|OTHER|Treatment comparison||||||0.14|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.14
91559803|NCT04821271|183008387|OTHER|Treatment comparison||||||0.12|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.12
91559804|NCT04821271|183008388|OTHER|Treatment comparison||||||0.69|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.69
91559805|NCT04821271|183008389|OTHER|Treatment comparison||||||0.73|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.73
91559806|NCT04821271|183008390|OTHER|Treatment comparison||||||0.28|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.28
91559807|NCT02008916|183008414|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0093|TWO_SIDED|95.0|1.24|4.69|||Regression, Logistic|||||4.69|1.24|0.0093
91559808|NCT02008916|183008414|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0037|TWO_SIDED|95.0|1.38|5.21|||Regression, Logistic|||||5.21|1.38|0.0037
91559809|NCT02008916|183008415|SUPERIORITY||Odds Ratio (OR)|2.59||||0.01|TWO_SIDED|95.0|1.26|5.35|||Regression, Logistic|||||5.35|1.26|0.0100
91559810|NCT02008916|183008415|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0051|TWO_SIDED|95.0|1.36|5.78|||Regression, Logistic|||||5.78|1.36|0.0051
91559811|NCT02008916|183008416|SUPERIORITY||Relative treatment effect|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.68|0.38|<0.0001
91559812|NCT02008916|183008416|SUPERIORITY||Relative treatment effect|0.44|||<|0.0001|TWO_SIDED|95.0|0.33|0.6|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.60|0.33|<0.0001
91559813|NCT02008916|183008417|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0002|TWO_SIDED|95.0|2.01|9.92|||Regression, Logistic|||||9.92|2.01|0.0002
91559814|NCT02008916|183008417|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0004|TWO_SIDED|95.0|1.89|9.38|||Regression, Logistic|||||9.38|1.89|0.0004
91768766|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|21.7||||0.034|TWO_SIDED|95.0|2.0|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.3|2.0|0.034
91559815|NCT02008916|183008418|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.39||0.0347|TWO_SIDED|95.0|-1.6|-0.06|||Mixed Models Analysis|||||-0.06|-1.60|0.0347
91559816|NCT02008916|183008418|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.39||0.0018|TWO_SIDED|95.0|-2.0|-0.46|||Mixed Models Analysis|||||-0.46|-2.00|0.0018
91559817|NCT02008916|183008422|SUPERIORITY||Odds Ratio (OR)|7.71||||0.0593|TWO_SIDED|95.0|0.92|64.42|||Regression, Logistic|||||64.42|0.92|0.0593
91559818|NCT02008916|183008422|SUPERIORITY||Odds Ratio (OR)|19.39||||0.0046|TWO_SIDED|95.0|2.49|150.79|||Regression, Logistic|||||150.79|2.49|0.0046
91559819|NCT01915914|183008431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|13.4993|||<|0.0001|TWO_SIDED|95.0|4.1113|44.325|||Log Rank|||||44.3250|4.1113|<0.0001
91559820|NCT01915914|183008432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.9524|||<|0.0001|TWO_SIDED|95.0|2.4258|10.1105|||Log Rank|||||10.1105|2.4258|<0.0001
91559821|NCT01915914|183008433|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91559822|NCT01915914|183008434|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91559823|NCT01915914|183008436|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91559824|NCT01915914|183008437|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
91559825|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Week 20, CA|Wilcoxon (Mann-Whitney)|||||||0.7010
91559826|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||Week 20, ET/L|Wilcoxon (Mann-Whitney)|||||||0.0042
91559827|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Week 20, AP|Wilcoxon (Mann-Whitney)|||||||0.0810
91559828|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.2799||95.0||||Week 32, CA|Wilcoxon (Mann-Whitney)|||||||0.2799
91559829|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.1375||95.0||||Week 32, ET/L|Wilcoxon (Mann-Whitney)|||||||0.1375
91559830|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Week 32, AP|Wilcoxon (Mann-Whitney)|||||||0.1100
91559831|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.0394||95.0||||Week 20, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.0394
91559832|NCT01915914|183008442|SUPERIORITY_OR_OTHER|||||||0.2237||95.0||||Week 32, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.2237
91559833|NCT03365622|183008480|SUPERIORITY||Mean Difference (Final Values)|6.306|STANDARD_ERROR_OF_MEAN|7.379||0.3938|TWO_SIDED|95.0|-8.242|20.854|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the total opioid dose administered intraoperatively and postoperatively, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||20.854|-8.242|0.3938
91559834|NCT03365622|183008481|SUPERIORITY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.283||0.7051|TWO_SIDED|95.0|-0.451|0.666|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.666|-0.451|0.7051
91559835|NCT03365622|183008482|SUPERIORITY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.317||0.3852|TWO_SIDED|95.0|-0.349|0.901|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.901|-0.349|0.3852
91559836|NCT03365622|183008483|SUPERIORITY||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|2.816||0.8498|TWO_SIDED|95.0|-5.02|6.088|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||6.088|-5.02|0.8498
91559837|NCT03365622|183008484|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.007||0.5839|TWO_SIDED|95.0|-7.579|4.28|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||4.28|-7.579|0.5839
91768767|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-15.9|18.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||18.3|-15.9|1.000
91559838|NCT03365622|183008485|SUPERIORITY||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.344||0.2479|TWO_SIDED|95.0|-0.28|1.078|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.078|-0.280|0.2479
91768768|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
91768769|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
91768770|NCT02365649|183425723|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
91768771|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|15.0||||0.536|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.536
91559839|NCT03365622|183008486|SUPERIORITY||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.335||0.1502|TWO_SIDED|95.0|-0.177|1.145|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.145|-0.177|0.1502
91559840|NCT03365622|183008487|SUPERIORITY||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.313||0.2797|TWO_SIDED|95.0|-0.278|0.955|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op surgical pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.955|-0.278|0.2797
91559841|NCT03365622|183008488|SUPERIORITY||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.739||0.6527|TWO_SIDED|95.0|-1.792|1.125|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to first narcotic use, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.125|-1.792|0.6527
91559842|NCT03365622|183008489|SUPERIORITY||Odds Ratio (OR)|0.465||||0.0499|TWO_SIDED|95.0|0.217|1.0|||Regression, Logistic|Adjusted for age, sex, BMI, type of surgery and TAP block.||A logistic regression model was used to examine the association between treatment assignment and incidence of nausea, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.000|0.217|0.0499
91559843|NCT03365622|183008490|SUPERIORITY||Mean Difference (Final Values)|24.492|STANDARD_ERROR_OF_MEAN|18.165||0.179|TWO_SIDED|95.0|-11.321|60.304|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to discharge from PACU, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||60.304|-11.321|0.179
91559844|NCT03365622|183008491|SUPERIORITY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.253||0.2811|TWO_SIDED|95.0|-0.226|0.773|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to hospital discharge, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.773|-0.226|0.2811
91559845|NCT01241448|183008524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29||||0.094|TWO_SIDED|90.0|-0.58|-0.01||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.01|-0.58|0.094
91559846|NCT01241448|183008524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.62|||<|0.001|TWO_SIDED|90.0|-0.9|-0.34||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.34|-0.90|<0.001
91768772|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|15.0||||0.238|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.238
91559847|NCT01241448|183008524|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.77|||<|0.01|TWO_SIDED|90.0|-1.05|-0.48||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.48|-1.05|<0.01
91768773|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-34.3|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||24.3|-34.3|1.000
91768774|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.0||||0.606|TWO_SIDED|95.0|-43.8|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||23.8|-43.8|0.606
91768775|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-28.5|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||21.0|-28.5|1.000
91559848|NCT02065895|183008549|OTHER|ANOVA was used to first tests the hypothesis that there is a difference among the three groups.|Mean Difference (Final Values)|66.8||||0.0011|TWO_SIDED|95.0|33.4|80.3||The p value was adjusted for multiple comparisons using Sidak's correction. A priori the pimary outcome was defined as blood glucose AUC from 8 am - 12pm; however we used blood glucose AUC from 8am - 2pm to capture the entire meal response.|ANOVA|||Differences among the 3 groups were assessed by repeated measures ANOVA using Sidak's correction for multiple comparisons. All subjects were analyzed as a single group, no comparison group.||80.3|33.4|0.0011
91559849|NCT02065895|183008550|OTHER|||||||0.0059|||||||ANOVA|||||||0.0059
91559850|NCT03740737|183008552|OTHER||Treatment difference|63.0|||<|0.001|TWO_SIDED|95.0|55.5|67.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||67.1|55.5|<0.001
91559851|NCT03740737|183008553|OTHER||Treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|22.5|33.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||33.7|22.5|<0.001
91559852|NCT03740737|183008557|OTHER||Treatment difference|31.8|||<|0.001|TWO_SIDED|95.0|24.7|36.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||36.0|24.7|<0.001
91559853|NCT03740737|183008557|OTHER||Treatment difference|68.2|||<|0.001|TWO_SIDED|95.0|61.2|72.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||72.1|61.2|<0.001
91559854|NCT03740737|183008558|OTHER||Treatment difference|30.5|||<|0.001|TWO_SIDED|95.0|23.4|34.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||34.6|23.4|<0.001
91559855|NCT03740737|183008558|OTHER||Treatment difference|65.1|||<|0.001|TWO_SIDED|95.0|57.5|69.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||69.1|57.5|<0.001
91559856|NCT03740737|183008560|OTHER||Treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|28.1|39.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||39.2|28.1|<0.001
91768776|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||9.2|-59.2|0.181
91768777|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
91768778|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
91559857|NCT03740737|183008560|OTHER||Treatment difference|72.4|||<|0.001|TWO_SIDED|95.0|65.3|76.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||76.2|65.3|<0.001
91559858|NCT03740737|183008572|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91768779|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||11.3|-61.3|0.231
91559859|NCT03740737|183008573|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
91559860|NCT03740737|183008574|OTHER|||||||0.22|||||||Fisher Exact|||||||0.220
91559861|NCT03740737|183008575|OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
91768780|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||69.2|5.8|0.099
91559862|NCT00507429|183008621|SUPERIORITY_OR_OTHER|||||||0.223|||||||Log Rank|||||||0.223
91559863|NCT03034863|183008649|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
91559864|NCT03034863|183008650|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.69
91559865|NCT03034863|183008651|SUPERIORITY|||||||0.49||||||All p-values are two-tailed|Fisher Exact|Compares veterans who reported 1+ attempts at any follow-up wave out of total number of veterans in each group (i.e., 0/19 for SAFER; 2/20 for I-SPI).||||||.49
91559866|NCT03034863|183008652|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
91559867|NCT03034863|183008653|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.87|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.87
91559868|NCT03034863|183008654|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
91559869|NCT03034863|183008655|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.16|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
91559870|NCT03034863|183008656|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.81|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.81
91559871|NCT03034863|183008657|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.62||0.55|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.55
91559872|NCT03034863|183008658|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.64
91768781|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|31.3||||0.052|TWO_SIDED|95.0|2.2|60.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.3|2.2|0.052
91768782|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
91559873|NCT03034863|183008659|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.62|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.62
91559874|NCT03034863|183008660|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.16|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
91559875|NCT03137784|183008661|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.089|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
91559876|NCT03137784|183008661|OTHER||Linear Mixed Model (LMM)|0.09|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
91559877|NCT03137784|183008662|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.165|||<|0.001|TWO_SIDED|95.0|0.127|0.203|||Linear Mixed Model|||||0.203|0.127|<0.001
91559878|NCT03137784|183008662|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.168|||<|0.001|TWO_SIDED|95.0|0.129|0.206|||Linear Mixed Model|||||0.206|0.129|<0.001
91559879|NCT03137784|183008663|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.176|||<|0.001|TWO_SIDED|95.0|0.141|0.212|||Linear Mixed Model|||||0.212|0.141|<0.001
91559880|NCT03137784|183008663|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.179|||<|0.001|TWO_SIDED|95.0|0.144|0.215|||Linear Mixed Model|||||0.215|0.144|<0.001
91559881|NCT03137784|183008664|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.139|||<|0.001|TWO_SIDED|95.0|0.106|0.173|||Linear Mixed Model|||||0.173|0.106|<0.001
91768783|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|32.5||||0.194|TWO_SIDED|95.0|0.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.1|0.9|0.194
91559882|NCT03137784|183008664|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.146|||<|0.001|TWO_SIDED|95.0|0.112|0.179|||Linear Mixed Model|||||0.179|0.112|<0.001
91559883|NCT03137784|183008665|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.164|||<|0.001|TWO_SIDED|95.0|0.127|0.201|||Linear Mixed Model|||||0.201|0.127|<0.001
91559884|NCT03137784|183008665|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.174|||<|0.001|TWO_SIDED|95.0|0.137|0.211|||Linear Mixed Model|||||0.211|0.137|<0.001
91559885|NCT03137784|183008666|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.036||||0.079|TWO_SIDED|95.0|-0.004|0.077|||Linear Mixed Model|||||0.077|-0.004|0.079
91559886|NCT03137784|183008666|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.058||||0.006|TWO_SIDED|95.0|0.017|0.099|||Linear Mixed Model|||||0.099|0.017|0.006
91559887|NCT03137784|183008668|OTHER|Treatment difference|Linear Mixed Model (LMM)|25.51|||<|0.001|TWO_SIDED|95.0|19.22|31.79|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||31.79|19.22|<0.001
91559888|NCT03137784|183008668|OTHER|Treatment difference|Linear Mixed Model (LMM)|24.29|||<|0.001|TWO_SIDED|95.0|17.99|30.59|||Linear Mixed Model|||||30.59|17.99|<0.001
91559889|NCT03137784|183008669|OTHER|Treatment difference|Linear Mixed Model (LMM)|30.95|||<|0.001|TWO_SIDED|95.0|25.07|36.82|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||36.82|25.07|<0.001
91559890|NCT03137784|183008669|OTHER|Treatment difference|Linear Mixed Model (LMM)|29.37|||<|0.001|TWO_SIDED|95.0|23.47|35.26|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||35.26|23.47|<0.001
91559891|NCT03137784|183008670|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Linear Mixed Model|||||0.00|-0.31|0.053
91559892|NCT03137784|183008670|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.11||||0.163|TWO_SIDED|95.0|-0.27|0.05|||Linear Mixed Model|||||0.05|-0.27|0.163
91559893|NCT03331978|183008671|SUPERIORITY||Mean Difference (Net)|6.89|STANDARD_ERROR_OF_MEAN|3.91||0.08|TWO_SIDED|95.0|-0.82|14.61|||Regression, Linear|Model is adjusted for participant sex, which was found to be significantly associated with adherence in a similar repeated measures model.|Values entered are for regression coefficient for intervention indicator (versus control) and represents the adjusted difference across all follow-up time points.|Tested with repeated measures linear regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and continuous adherence measured at baseline. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||14.61|-0.82|.08
91559894|NCT03331978|183008672|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0257|TWO_SIDED|95.0|1.09|3.6||Per above, p-value is from repeated measures logistic regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and baseline dichotomous adherence. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||3.60|1.09|.0257
91559895|NCT03331978|183008673|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.64|5.18||As mentioned above, p-value comes from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention measurements were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for presence of viral suppression data were used. Fixed effects were an intervention indicator and baseline viral suppression. Model included all viral suppression data (a) at baseline and (b) close to either of the two follow-up surveys.||5.18|0.64|.26
91559896|NCT03331978|183008674|SUPERIORITY||Odds Ratio (OR)|0.57||||0.05|TWO_SIDED|95.0|0.32|1.0||As mentioned above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||1.00|0.32|.05
91559897|NCT03331978|183008675|SUPERIORITY||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.091||0.0199|TWO_SIDED|95.0|-0.395|-0.034||As described above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant|Regression, Linear||Estimation parameter is the regression coefficient for intervention indicator (vs. control) and represents the adjusted difference across both follow-up time points.|Tested with repeated measures linear regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||-0.034|-0.395|.0199
91768784|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||45.2|-17.7|0.400
91768785|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.9|32.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||32.9|-42.9|1.000
91559898|NCT04803734|183008680|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed Cmax.|Ratio of geometric least square mean|0.862||||0.0328|TWO_SIDED|90.0|0.807|0.922|||ANOVA|||||0.922|0.807|0.0328
91559899|NCT04803734|183008681|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-t).|Ratio of geometric least square mean|0.941|||<|0.0001|TWO_SIDED|90.0|0.909|0.976|||ANOVA|||||0.976|0.909|<0.0001
91559900|NCT04803734|183008682|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-inf).|Ratio of geometric least square mean|0.942|||<|0.0001|TWO_SIDED|90.0|0.91|0.975|||ANOVA|||||0.975|0.910|<0.0001
91559901|NCT00854594|183008757|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: pre-intervention efficacies will be equal in the two study arms.||||0.26
91559902|NCT00854594|183008758|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: post-intervention efficacies will be equal in the two study arms.||||0.74
91559903|NCT04471805|183008767|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
91559904|NCT04471805|183008768|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
91559905|NCT01393600|183008770|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.3||0.588|TWO_SIDED|95.0|-3.3|1.9|||ANOVA|||||1.9|-3.3|0.5880
91559906|NCT01393600|183008770|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.4184|TWO_SIDED|95.0|-3.8|1.6|||ANOVA|||||1.6|-3.8|0.4184
91559907|NCT01393600|183008772|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6761|TWO_SIDED|95.0|-2.4|1.6|||ANOVA|||||1.6|-2.4|0.6761
91768786|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|16.3||||0.477|TWO_SIDED|95.0|-18.6|51.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||51.1|-18.6|0.477
91559908|NCT01393600|183008772|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0015|TWO_SIDED|95.0|-6.6|-1.8|||ANOVA|||||-1.8|-6.6|0.0015
91559909|NCT04540952|183008777|SUPERIORITY|Power analysis indicated that with a sample size of 34 per arm, would provide 81% power to detect an effect size of 0.7 (0.7\*SD of fluid deficit) with a two-sided, two sample t test (a=0.05).|Mean Difference (Final Values)|11.3||||0.93|TWO_SIDED|95.0|-260.7|283.4|||t-test, 2 sided|||||283.4|-260.7|0.93
91559910|NCT01163214|183008781|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
91768787|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-2.6||||0.833|TWO_SIDED|95.0|-26.4|21.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.3|-26.4|0.833
91559911|NCT01163214|183008781|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
91559912|NCT01163214|183008782|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
91559913|NCT01163214|183008782|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
91559914|NCT01163214|183008783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for intraoperative narcotic use.||||<0.001
91559915|NCT01163214|183008783|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on day of surgery as needed.||||<0.001
91559916|NCT01163214|183008783|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 1 as needed.||||0.17
91559917|NCT01163214|183008783|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 2 as needed.||||0.51
91559918|NCT01163214|183008784|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 morning.||||<0.001
91559919|NCT01163214|183008784|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 afternoon.||||<0.001
91559920|NCT01163214|183008784|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 morning.||||0.002
91559921|NCT01163214|183008784|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 afternoon.||||0.97
91559922|NCT01163214|183008785|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for length of stay in the hospital.||||0.02
91559923|NCT01163214|183008786|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral nerve.||||0.49
91559924|NCT01163214|183008786|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for common peroneal nerve.||||0.01
91559925|NCT01163214|183008786|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for tibial nerve.||||0.62
91559926|NCT01163214|183008786|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral, peroneal, or tibial nerves.||||0.009
91559927|NCT02964234|183008787|SUPERIORITY||Odds Ratio (OR)|10.59||||0.005|TWO_SIDED|95.0|2.01|56.31||We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.|Regression, Logistic|||We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).||56.31|2.01|.005
91559928|NCT02964234|183008788|SUPERIORITY||Slope|-0.19||||0.03|TWO_SIDED|95.0|-0.34|-0.04|||Regression, Linear|With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.||Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.||-0.04|-0.34|0.03
91559929|NCT02964234|183008789|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.82|13.32||Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.|Ordinal regression|||We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).||13.32|2.82|<0.0001
91559930|NCT01799993|183008790|SUPERIORITY||Odds Ratio (OR)|0.841||||0.4263|TWO_SIDED|95.0|0.554|1.277|||Cochran-Mantel-Haenszel|||||1.277|0.554|0.4263
91559931|NCT01799993|183008791|SUPERIORITY|||||||0.6421|||||||Chi-squared|||||||0.6421
91559932|NCT01799993|183008792|SUPERIORITY|||||||0.7984|||||||Chi-squared|||||||0.7984
91559933|NCT01799993|183008793|SUPERIORITY|||||||0.7144|||||||ANOVA|||||||0.7144
91559934|NCT01799993|183008794|SUPERIORITY|||||||0.4278|||||||ANOVA|||||||0.4278
91559935|NCT01263223|183008812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||<|0.0001|TWO_SIDED|95.0|7.4|12.0||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||12.0|7.4|<0.0001
91559936|NCT01263223|183008812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4|||<|0.0001|TWO_SIDED|95.0|17.9|30.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||30.9|17.9|<0.0001
91768788|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-4.6||||0.732|TWO_SIDED|95.0|-30.9|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.7|-30.9|0.732
91768789|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|19.4||||0.468|TWO_SIDED|95.0|-15.4|54.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.2|-15.4|0.468
91559937|NCT01263223|183008813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||8.8|3.9|<0.0001
91559938|NCT01263223|183008813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.0025|TWO_SIDED|95.0|2.6|11.6||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||11.6|2.6|0.0025
91559939|NCT01263223|183008813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51|||<|0.0001|TWO_SIDED|95.0|3.81|7.21||P-value is for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||7.21|3.81|<0.0001
91559940|NCT01263223|183008813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.002|TWO_SIDED|95.0|2.13|9.2||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||9.20|2.13|0.0020
91559941|NCT01263223|183008814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.0224|TWO_SIDED|95.0|0.418|5.38||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||5.38|0.418|0.0224
91559942|NCT01263223|183008814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7||||0.2453|TWO_SIDED|95.0|-1.88|7.29||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||7.29|-1.88|0.2453
91559943|NCT01263223|183008814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.37|6.82||P-value if for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||6.82|3.37|<0.0001
91559944|NCT01263223|183008814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0005|TWO_SIDED|95.0|2.95|10.1||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||10.1|2.95|0.0005
91559945|NCT01263223|183008815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.0001|TWO_SIDED|95.0|8.7|16.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||16.9|8.7|<0.0001
91559946|NCT01263223|183008815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0||||0.0001|TWO_SIDED|95.0|11.4|34.5||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.5|11.4|0.0001
91559947|NCT01263223|183008816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.212|TWO_SIDED|95.0|-1.6|7.2||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||7.2|-1.6|0.2120
91559948|NCT01263223|183008816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6||||0.064|TWO_SIDED|95.0|-0.4|15.5||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||15.5|-0.4|0.0640
91559949|NCT01263223|183008816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.0211|TWO_SIDED|95.0|0.5|6.7||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.7|0.5|0.0211
91768790|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-11.2||||0.339|TWO_SIDED|95.0|-34.1|11.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.7|-34.1|0.339
91559950|NCT01263223|183008816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.8719|TWO_SIDED|95.0|-5.7|6.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.8|-5.7|0.8719
91559951|NCT01263223|183008817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7133|TWO_SIDED|95.0|-5.3|3.7||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||3.7|-5.3|0.7133
91559952|NCT01263223|183008817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.4638|TWO_SIDED|95.0|-17.2|7.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||7.9|-17.2|0.4638
91559953|NCT01263223|183008818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|95.0|11.3|15.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||15.9|11.3|<0.0001
91559954|NCT01263223|183008818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.6|||<|0.0001|TWO_SIDED|95.0|21.1|34.2||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.2|21.1|<0.0001
91559955|NCT01263223|183008819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9609|TWO_SIDED|95.0|-4.9|4.7||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||4.7|-4.9|0.9609
91559956|NCT01263223|183008819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.2731|TWO_SIDED|95.0|-3.9|13.6||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||13.6|-3.9|0.2731
91559957|NCT01263223|183008819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3779|TWO_SIDED|95.0|-4.8|1.8||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||1.8|-4.8|0.3779
91559958|NCT01263223|183008819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0828|TWO_SIDED|95.0|-12.8|0.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||0.8|-12.8|0.0828
91559959|NCT02246647|183008820|OTHER||Mean Difference (Final Values)|0.01||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
91559960|NCT04387773|183008834|SUPERIORITY||Mean Difference (Final Values)|2.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
91559961|NCT04387773|183008835|SUPERIORITY||Mean Difference (Final Values)|14.98|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
91559962|NCT04387773|183008836|SUPERIORITY||Mean Difference (Final Values)|2393.2||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
91559963|NCT04387773|183008837|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.012|TWO_SIDED||||||t-test, 2 sided|||||||0.012
91559964|NCT04387773|183008838|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
91559965|NCT04405180|183008869|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|4.0||0.9017|TWO_SIDED|||||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data|ANCOVA|||||||0.9017
91559966|NCT04405180|183008870|SUPERIORITY||Mean Difference (Net)|0.0342|STANDARD_ERROR_OF_MEAN|0.0417||0.4215|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.4215
91559967|NCT04405180|183008871|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|53.0||0.9024|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||.9024
91559968|NCT04405180|183008872|SUPERIORITY||Mean Difference (Net)|-59.0|STANDARD_ERROR_OF_MEAN|42.0||0.1646|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.1646
91559969|NCT04405180|183008873|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.2||0.9814|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.9814
91559970|NCT04405180|183008874|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6217|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6217
91559971|NCT04405180|183008875|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.7981|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.7981
91559972|NCT04405180|183008876|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6677|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6677
91559973|NCT04405180|183008877|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.1||0.3745|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.3745
91559974|NCT04405180|183008878|SUPERIORITY||Mean Difference (Net)|243.0|STANDARD_ERROR_OF_MEAN|400.0||0.5496|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.5496
91559975|NCT03031782|183008891|SUPERIORITY||Cox Proportional Hazard|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.63|||Log Rank|Hazard ratios and associated 95% confidence intervals are based on a Cox proportional hazards model with treatment and analysis factors||Survival analysis of time to flare - TP2 (FAS2)||0.63|0.13|<0.001
91559976|NCT04867382|183008902|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.27||0.63|TWO_SIDED||||||t-test, 2 sided|||||||.63
91559977|NCT04867382|183008903|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
91559978|NCT04867382|183008904|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.37|TWO_SIDED||||||t-test, 2 sided|||||||.37
91559979|NCT04867382|183008905|SUPERIORITY||Odds Ratio (OR)|1.75||||0.12|TWO_SIDED|95.0|0.86|3.57|||Regression, Logistic|||||3.57|0.86|.12
91559980|NCT01323790|183008917|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.188||||0.202|TWO_SIDED|95.0|0.911|1.548|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.548|0.911|0.202
91559981|NCT01323790|183008917|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.348||||0.021|TWO_SIDED|95.0|1.045|1.739|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.739|1.045|0.021
91559982|NCT01323790|183008918|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.35||||0.074|TWO_SIDED|95.0|0.967|1.884||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||1.884|0.967|0.074
91559983|NCT01323790|183008918|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.489||||0.014|TWO_SIDED|95.0|1.078|2.058||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.058|1.078|0.014
91559984|NCT01323790|183008920|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.01|TWO_SIDED|95.0|0.09|0.69|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.69|0.09|0.010
91559985|NCT01323790|183008920|SUPERIORITY_OR_OTHER||Ls mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.37|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.37|<0.001
91559986|NCT01323790|183008921|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.005|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.06|-0.32|0.005
91559987|NCT01323790|183008921|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.18|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.18|-0.45|<0.001
91559988|NCT01323790|183008922|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.45|0.12|0.001
91559989|NCT01323790|183008922|SUPERIORITY_OR_OTHER||LS mean difference|0.45|||<|0.001|TWO_SIDED|95.0|0.29|0.62|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.62|0.29|<0.001
91559990|NCT01323790|183008923|SUPERIORITY_OR_OTHER||LS mean difference|6.72||||0.002|TWO_SIDED|95.0|2.37|11.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||11.06|2.37|0.002
91559991|NCT01323790|183008923|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|6.03|14.84|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||14.84|6.03|<0.001
91559992|NCT01323790|183008924|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.028|TWO_SIDED|95.0|0.06|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.06|0.028
91559993|NCT01323790|183008924|SUPERIORITY_OR_OTHER||LS mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.58|1.51|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.51|0.58|<0.001
91559994|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.08|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.080
91559995|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.011|TWO_SIDED|95.0|-0.32|-0.04||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.04|-0.32|0.011
91559996|NCT01323790|183008926|SUPERIORITY_OR_OTHER||Slope|0.05||||0.552|TWO_SIDED|95.0|-0.11|0.2||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.20|-0.11|0.552
91559997|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.236|TWO_SIDED|95.0|-0.06|0.25||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.25|-0.06|0.236
91559998|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.095|TWO_SIDED|95.0|-0.24|0.02||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.24|0.095
91559999|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.1||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.37|<0.001
91560000|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.002|TWO_SIDED|95.0|-0.44|-0.1||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.44|0.002
91560001|NCT01323790|183008926|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|||<|0.001|TWO_SIDED|95.0|-0.56|-0.21||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.21|-0.56|<0.001
91560002|NCT01323790|183008927|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.011|TWO_SIDED|95.0|-0.54|-0.07|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.54|0.011
91560003|NCT01323790|183008927|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.73|-0.25|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.25|-0.73|<0.001
91560004|NCT00046475|183008934|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
91768791|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-14.5||||0.263|TWO_SIDED|95.0|-39.3|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.3|0.263
91768792|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
91768793|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
91560005|NCT00046475|183008935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.011
91560006|NCT00046475|183008936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
91560007|NCT00046475|183008936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||0.002
91560008|NCT00046475|183008936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.004
91560009|NCT00046475|183008936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 5 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 5||||0.026
91560010|NCT00046475|183008936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 6 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 6||||0.226
91560011|NCT00046475|183008937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment composite symptom score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.002
91768794|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
91768795|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||37.1|-27.1|1.000
91768796|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|1.5||||0.891|TWO_SIDED|95.0|-19.6|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.6|-19.6|0.891
91560012|NCT00046475|183008938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 1||||<0.001
91560013|NCT00046475|183008938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
91560014|NCT00046475|183008938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||<0.001
91560015|NCT00046475|183008938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.001
91768797|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-3.3||||0.779|TWO_SIDED|95.0|-25.8|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.3|-25.8|0.779
91768798|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
91768799|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
91560016|NCT00046475|183008939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment global daily activity score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
91560017|NCT00046475|183008942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing systolic blood pressure||||0.002
91560018|NCT00046475|183008942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing diastolic blood pressure||||0.010
91560019|NCT00046475|183008943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine systolic blood pressure||||<0.001
91560020|NCT00046475|183008943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine diastolic blood pressure||||0.002
91560021|NCT00046475|183008944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 general health score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of general health||||0.569
91560022|NCT00046475|183008944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 physical functioning score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of physical functioning||||0.578
91560023|NCT00046475|183008948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with mild or moderate disease severity||||0.370
91560024|NCT00046475|183008949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with marked or severe disease severity||||0.007
91560025|NCT02432274|183008983|OTHER||||||=|0.20359|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.20359
91768800|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
91768801|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|21.9||||0.083|TWO_SIDED|95.0|7.6|36.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||36.2|7.6|0.083
91768802|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|15.0||||0.151|TWO_SIDED|95.0|-2.1|32.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.0|-2.1|0.151
91560026|NCT02432274|183008983|OTHER||||||=|0.50068|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.50068
91560027|NCT02432274|183008983|OTHER||||||=|0.05512|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 19 (PFS-4, Yes) vs. C3D1: FGF 19 (PFS-4, No)||||=0.05512
91560028|NCT02432274|183008983|OTHER||||||=|0.50382|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 19 (PFS-4, Yes) vs. C4D1: FGF 19 (PFS-4, No)||||=0.50382
91560029|NCT02432274|183008983|OTHER||||||=|0.0476|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.04760
91560030|NCT02432274|183008983|OTHER||||||=|0.2142|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.21420
91560031|NCT02432274|183008983|OTHER||||||=|0.42542|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 21 (PFS-4, Yes) vs. C3D1: FGF 21 (PFS-4, No)||||=0.42542
91560032|NCT02432274|183008983|OTHER||||||=|0.73573|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 21 (PFS-4, Yes) vs. C4D1: FGF 21 (PFS-4, No)||||=0.73573
91560033|NCT02432274|183008983|OTHER||||||=|0.35754|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.35754
91560034|NCT02432274|183008983|OTHER||||||=|0.59903|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.59903
91560035|NCT02432274|183008983|OTHER||||||=|1|||||||Wilcoxon Rank-Sum Test|||C3D1: VEGF (PFS-4, Yes) vs. C3D1: VEGF (PFS-4, No)||||=1.00000
91560036|NCT01736475|183008988|SUPERIORITY_OR_OTHER_LEGACY||Ratio of means|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.19|||Regression, Negative binomial|||Ratio Annualized Bleeding Rate (ABR) Prophylaxis/On-demand: Prophylaxis treatment w ill be considered to be successful if the upper limit of the 95% CI for the ratio between treatment regimen does not exceed 0.5 (corresponding to a 50% reduction of the mean ABR compared to the on-demand treatment). H01: μ1 ≥0.5\*μ2 Ha1: μ1\<0.5\*μ2 w here μ1 and μ2 are the mean ABRs in on prophylaxis and on-demand, respectively||0.19|0.06|<0.0001
91560037|NCT02144285|183009083|SUPERIORITY_OR_OTHER||Absolute Bioavailability|0.45|||||TWO_SIDED|90.0|0.34|0.6||||||||0.60|0.34|
91560038|NCT02834624|183009142|OTHER||||||<|0.05|||||||t-test, 1 sided|||Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.||||<.05
91560039|NCT02834624|183009144|OTHER|||||||0.63|||||||t-test, 1 sided|||||||0.63
91560040|NCT01250717|183009162|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|0|
91560041|NCT02164578|183009163|SUPERIORITY|||||||0.004|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||The hypothesis H0 is tested against the one-sided alternative hypothesis H1 H0: µ∆FBF,Riva, week 20 ≤ µ∆FBF, ASA, week 20 versus H1: µΔFBF, Riva, week 20 \> µΔFBF, ASA, week 20 by test procedures for continuous data.||||0.004
91560042|NCT02164578|183009164|OTHER|||||||0.07|||||||ANCOVA|||||||0.070
91560043|NCT02164578|183009165|OTHER|||||||0.045|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||||||0.045
91560044|NCT02164578|183009166|OTHER|||||||0.125|||||||ANCOVA|||||||0.125
91560045|NCT02164578|183009167|OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
91560046|NCT02164578|183009168|OTHER|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
91560047|NCT02507297|183009176|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.367
91560048|NCT02507297|183009176|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.48
91560049|NCT02507297|183009177|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.136
91560050|NCT02507297|183009177|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.324
91560051|NCT02507297|183009178|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.916
91560052|NCT02507297|183009178|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.752
91560053|NCT02507297|183009179|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.568
91560054|NCT02507297|183009179|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.568
91560055|NCT02507297|183009180|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||.486
91560056|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.101|||||||ANOVA|||Baseline (AM)||||0.101
91560057|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||ANOVA|||Change at Week 1 (AM)||||0.168
91560058|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||ANOVA|||Change at Week 2 (AM)||||0.930
91560059|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487|||||||ANOVA|||Change at Week 3 (AM)||||0.487
91560060|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.914|||||||ANOVA|||Change at Week 4 (AM)||||0.914
91560061|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|||||||ANOVA|||Change at Final Week (AM)||||0.977
91560062|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|||||||ANOVA|||Baseline (PM)||||0.109
91560063|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|||||||ANOVA|||Change at Week 1 (PM)||||0.291
91560064|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|||||||ANOVA|||Change at Week 2 (PM)||||0.984
91560065|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Change at Week 3 (PM)||||0.373
91560066|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.623|||||||ANOVA|||Change at Week 4 (PM)||||0.623
91560067|NCT00070707|183009196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978|||||||ANOVA|||Change at Final Week (PM)||||0.978
91560068|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Baseline (AM)||||0.023
91560069|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 1 (AM)||||0.693
91768803|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-22.4|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||24.1|-22.4|1.000
91560070|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||ANOVA|||Change at Week 2 (AM)||||0.483
91560071|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|||||||ANOVA|||Change at Week 3 (AM)||||0.088
91560072|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||ANOVA|||Change at Week 4 (AM)||||0.210
91768804|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-25.4|26.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||26.3|-25.4|1.000
91560073|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||ANOVA|||Change at Final Week (AM)||||0.178
91560074|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055|||||||ANOVA|||Baseline (PM)||||0.055
91560075|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Week 1 (PM)||||0.915
91560076|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471|||||||ANOVA|||Change at Week 2 (PM)||||0.471
91560077|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||ANOVA|||Change at Week 3 (PM)||||0.110
91560078|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|||||||ANOVA|||Change at Week 4 (PM)||||0.305
91560079|NCT00070707|183009197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|||||||ANOVA|||Change at Final Week (PM)||||0.461
91560080|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANOVA|||Baseline (AM)||||0.068
91560081|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Change at Week 1 (AM)||||0.116
91560082|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.749|||||||ANOVA|||Change at Week 2 (AM)||||0.749
91560083|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.289|||||||ANOVA|||Change at Week 3 (AM)||||0.289
91560084|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.982|||||||ANOVA|||Change at Week 4 (AM)||||0.982
91560085|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.941|||||||ANOVA|||Change at Final Week (AM)||||0.941
91560086|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|||||||ANOVA|||Baseline (PM)||||0.128
91560087|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|||||||ANOVA|||Change at Week 1 (PM)||||0.484
91560088|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||ANOVA|||Change at Week 2 (PM)||||0.673
91560089|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 3 (PM)||||0.250
91560090|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||Change at Week 4 (PM)||||0.450
91560091|NCT00070707|183009198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.774|||||||ANOVA|||Change at Final Week (PM)||||0.774
91560092|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANOVA|||Baseline (AM)||||0.078
91560093|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492|||||||ANOVA|||Change at Week 1 (AM)||||0.492
91560094|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||ANOVA|||Change at Week 2 (AM)||||0.945
91560095|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||Change at Week 3 (AM)||||0.359
91560096|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.802|||||||ANOVA|||Change at Week 4 (AM)||||0.802
91560097|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|||||||ANOVA|||Change at Final Week (AM)||||0.716
91560098|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||ANOVA|||Baseline (PM)||||0.158
91560099|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.281|||||||ANOVA|||Change at Week 1 (PM)||||0.281
91560100|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.901|||||||ANOVA|||Change at Week 2 (PM)||||0.901
91560101|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.433|||||||ANOVA|||Change at Week 3 (PM)||||0.433
91560102|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||ANOVA|||Change at Week 4 (PM)||||0.730
91560103|NCT00070707|183009199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.819|||||||ANOVA|||Change at Final Week (PM)||||0.819
91560104|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629|||||||ANOVA|||Baseline (AM)||||0.629
91560105|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||ANOVA|||Change at Week 1 (AM)||||0.038
91560106|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.182|||||||ANOVA|||Change at Week 2 (AM)||||0.182
91560107|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 3 (AM)||||0.149
91560108|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||ANOVA|||Change at Week 4 (AM)||||0.035
91560109|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||ANOVA|||Change at Final Week (AM)||||0.056
91560110|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.711|||||||ANOVA|||Baseline (PM)||||0.711
91560111|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098|||||||ANOVA|||Change at Week 1 (PM)||||0.098
91560112|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356|||||||ANOVA|||Change at Week 2 (PM)||||0.356
91560113|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|||||||ANOVA|||Change at Week 3 (PM)||||0.529
91560114|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617|||||||ANOVA|||Change at Week 4 (PM)||||0.617
91560115|NCT00070707|183009200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||ANOVA|||Change at Final Week (PM)||||0.422
91560116|NCT00070707|183009201|SUPERIORITY_OR_OTHER_LEGACY|Baseline||||||0.532|||||||Cochran-Mantel-Haenszel|||||||0.532
91560117|NCT00070707|183009201|SUPERIORITY_OR_OTHER_LEGACY|Day 15||||||0.739|||||||Cochran-Mantel-Haenszel|||||||0.739
91560118|NCT00070707|183009201|SUPERIORITY_OR_OTHER_LEGACY|Day 29||||||0.227|||||||Cochran-Mantel-Haenszel|||||||0.227
91560119|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||ANOVA|||Baseline (AM)||||0.104
91560120|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 1 (AM)||||0.022
91560121|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||Change at Week 2 (AM)||||0.012
91560122|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
91560123|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|||||||ANOVA|||Change at Week 4 (AM)||||0.033
91560124|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||ANOVA|||Change at Final Week (AM)||||0.047
91560125|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269|||||||ANOVA|||Baseline (PM)||||0.269
91560126|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.308|||||||ANOVA|||Change at Week 1 (PM)||||0.308
91560127|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Change at Week 2 (PM)||||0.050
91560128|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 3 (PM)||||0.014
91560129|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||ANOVA|||Change at Week 4 (PM)||||0.100
91560130|NCT00070707|183009202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|||||||ANOVA|||Change at Final Week (PM)||||0.139
91560131|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Baseline (AM)||||0.136
91560132|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.126|||||||ANOVA|||Change at Week 1 (AM)||||0.126
91560133|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107|||||||ANOVA|||Change at Week 2 (AM)||||0.107
91560134|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||ANOVA|||Change at Week 3 (AM)||||0.006
91560135|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||Change at Week 4 (AM)||||0.030
91560136|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|||Change at Final Week (AM)||||0.037
91560137|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||ANOVA|||Baseline (PM)||||0.146
91560138|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|||||||ANOVA|||Change at Week 1 (PM)||||0.426
91560139|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259|||||||ANOVA|||Change at Week 2 (PM)||||0.259
91560140|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||ANOVA|||Change at Week 3 (PM)||||0.026
91560141|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 4 (PM)||||0.022
91560142|NCT00070707|183009203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANOVA|||Change at Final Week (PM)||||0.043
91560143|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||ANOVA|||Baseline (AM)||||0.181
91560144|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
91560145|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
91560146|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|||Change at Week 3 (AM)||||0.002
91560147|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||ANOVA|||Change at Week 4 (AM)||||0.027
91560148|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||ANOVA|||Change at Final Week (AM)||||0.069
91560149|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Baseline (PM)||||0.373
91560150|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||ANOVA|||Change at Week 1 (PM)||||0.148
91560151|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||ANOVA|||Change at Week 2 (PM)||||0.009
91560152|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||ANOVA|||Change at Week 3 (PM)||||0.016
91560153|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Change at Week 4 (PM)||||0.113
91560154|NCT00070707|183009204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173|||||||ANOVA|||Change at Final Week (PM)||||0.173
91560155|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|||||||ANOVA|||Baseline (AM)||||0.089
91560156|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
91560157|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
91560158|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
91560159|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||ANOVA|||Change at Week 4 (AM)||||0.041
91560160|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||ANOVA|||Change at Final Week (AM)||||0.036
91560161|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||ANOVA|||Baseline (PM)||||0.170
91560162|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|||||||ANOVA|||Change at Week 1 (PM)||||0.237
91560163|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||ANOVA|||Change at Week 2 (PM)||||0.019
91560164|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|||Change at Week 3 (PM)||||0.018
91560165|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 4 (PM)||||0.149
91560166|NCT00070707|183009205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||ANOVA|||Change at Final Week (PM)||||0.231
91560167|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.745|||||||ANOVA|||Baseline (AM)||||0.745
91560168|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 1 (AM)||||0.250
91560169|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (AM)||||||0.202|||||||ANOVA|||||||0.202
91560170|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (AM)||||||0.104|||||||ANOVA|||||||0.104
91560171|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (AM)||||||0.348|||||||ANOVA|||||||0.348
91560172|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (AM)||||||0.355|||||||ANOVA|||||||0.355
91560173|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Baseline (PM)||||||0.851|||||||ANOVA|||||||0.851
91560174|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 1 (PM)||||||0.993|||||||ANOVA|||||||0.993
91560175|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (PM)||||||0.476|||||||ANOVA|||||||0.476
91560176|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (PM)||||||0.149|||||||ANOVA|||||||0.149
91560177|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (PM)||||||0.616|||||||ANOVA|||||||0.616
91560178|NCT00070707|183009206|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (PM)||||||0.527|||||||ANOVA|||||||0.527
91560179|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Baseline (AM)||||0.116
91560180|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Week 1 (AM)||||0.994
91560181|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||ANOVA|||Change at Week 2 (AM)||||0.961
91560182|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183|||||||ANOVA|||Change at Week 3 (AM)||||0.183
91560183|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||ANOVA|||Change at Week 4 (AM)||||0.440
91560184|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.838|||||||ANOVA|||Change at Final Week (AM)||||0.838
91560185|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096|||||||ANOVA|||Baseline (PM)||||0.096
91560186|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|||||||ANOVA|||Change at Week 1 (PM)||||0.362
91560187|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 2 (PM)||||0.693
91560188|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603|||||||ANOVA|||Change at Week 3 (PM)||||0.603
91560189|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579|||||||ANOVA|||Change at Week 4 (PM)||||0.579
91560190|NCT00070707|183009207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|||||||ANOVA|||Change at Final Week (PM)||||0.413
91560191|NCT00070707|183009208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
91560192|NCT00070707|183009208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744|||||||ANOVA|||Change at Day 15||||0.744
91560193|NCT00070707|183009208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675|||||||ANOVA|||Change at Day 29||||0.675
91560194|NCT00070707|183009209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Baseline||||0.693
91560195|NCT00070707|183009209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.818|||||||ANOVA|||Change at Day 15||||0.818
91560196|NCT00070707|183009209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Day 29||||0.915
91560197|NCT00070707|183009210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
91560198|NCT00070707|183009210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|||||||ANOVA|||Change at Day 15||||0.202
91560199|NCT00070707|183009210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.199|||||||ANOVA|||Change at Day 29||||0.199
91560200|NCT00070707|183009211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375|||||||ANOVA|||Baseline||||0.375
91560201|NCT00070707|183009211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||ANOVA|||Change at Week 1||||0.710
91560202|NCT00070707|183009211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.597|||||||ANOVA|||Change at Week 2||||0.597
91560203|NCT00070707|183009211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||ANOVA|||Change at Week 3||||0.242
91560204|NCT00070707|183009211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.696|||||||ANOVA|||Change at Week 4||||0.696
91560205|NCT00070707|183009211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||ANOVA|||Change at Final Week||||0.670
91560206|NCT00070707|183009212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865|||||||ANOVA|||Baseline||||0.865
91560207|NCT00070707|183009212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|||||||ANOVA|||Change at Week 1||||0.025
91560208|NCT00070707|183009212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|||||||ANOVA|||Change at Week 2||||0.288
91560209|NCT00070707|183009212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||Change at Week 3||||0.790
91560210|NCT00070707|183009212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.211|||||||ANOVA|||Change at Week 4||||0.211
91560211|NCT00070707|183009212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Change at Final Week||||0.136
91560212|NCT00070707|183009213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667|||||||ANOVA|||Baseline||||0.667
91560213|NCT00070707|183009213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656|||||||ANOVA|||Change at Week 1||||0.656
91560214|NCT00070707|183009213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||ANOVA|||Change at Week 2||||0.458
91560215|NCT00070707|183009213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANOVA|||Change at Week 3||||0.220
91560216|NCT00070707|183009213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|||||||ANOVA|||Change at Week 4||||0.775
91560217|NCT00070707|183009213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Final Week||||0.994
91560218|NCT00070707|183009214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.363|||||||ANOVA|||Baseline||||0.363
91560219|NCT00070707|183009214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||ANOVA|||Change at Week 1||||0.262
91560220|NCT00070707|183009214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386|||||||ANOVA|||Change at Week 2||||0.386
91560221|NCT00070707|183009214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|||||||ANOVA|||Change at Week 3||||0.167
91560222|NCT00070707|183009214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|||||||ANOVA|||Change at Week 4||||0.505
91560223|NCT00070707|183009214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725|||||||ANOVA|||Change at Final Week||||0.725
91560224|NCT00070707|183009215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.954|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 15||||0.954
91560225|NCT00070707|183009215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 29||||0.295
91560226|NCT00070707|183009216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 15||||0.268
91560227|NCT00070707|183009216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 29||||0.154
91560228|NCT01366976|183009223|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Mixed Models Analysis|||We hypothesized that acetaminophen would reduce peak isofuran concentrations by 22 pg/mL (40% reduction from peak concentrations). If the true difference in the acetaminophen and placebo group means is 22 pg/mL (SD=30 pg/mL), we would need to study 30 experimental subjects and 30 control subjects to be able to reject the null hypothesis that the population means of the acetaminophen and placebo groups are equal with probability (power) 0.8.||||0.05
91560229|NCT01366976|183009225|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
91560230|NCT01286311|183009259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.54|1.86|||Generalized Logistic Regression|||||1.86|0.54|0.99
91560231|NCT01286311|183009260|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.27|TWO_SIDED|95.0|0.84|1.85|||Generalized Logistic Regression|||||1.85|0.84|0.27
91560232|NCT01286311|183009261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.038|TWO_SIDED|95.0|1.05|4.32|||Generalized Logistic Regression|||||4.32|1.05|0.038
91560233|NCT01286311|183009262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72||||0.13|TWO_SIDED|95.0|0.73|10.1|||Generalized Logistic Regression|||||10.1|0.73|0.13
91560234|NCT01286311|183009263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.3|TWO_SIDED|95.0|0.5|9.5|||Generalized Logistic Regression|||||9.5|0.50|0.30
91560235|NCT00988429|183009301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||ANCOVA|||||||0.058
91560236|NCT00988429|183009301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
91560237|NCT00988429|183009302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANCOVA|||||||0.068
91560238|NCT00988429|183009302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
91560239|NCT01877720|183009325|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
91560240|NCT01877720|183009326|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Paired t-test|||||||0.001
91560241|NCT01877720|183009327|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Paired t-test|||||||0.74
91560242|NCT01877720|183009328|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
91560243|NCT01877720|183009329|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Paired t-test|||||||0.002
91560244|NCT01877720|183009330|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
91560245|NCT01877720|183009331|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Paired t-test|||||||0.012
91560246|NCT01877720|183009332|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Paired t-test|||||||0.67
91560247|NCT01877720|183009333|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
91560248|NCT01877720|183009334|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
91560249|NCT00267956|183009347|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The study is designed to maintain a Type I error of 0.05 or less for the primary analysis|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by subject's prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.||||<0.001
91560250|NCT00267956|183009348|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between Group II and Group I at a significant level of 0.05.||||0.004
91560251|NCT00267956|183009349|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||0.005
91560252|NCT00267956|183009350|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
91560253|NCT00267956|183009351|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
91560254|NCT00267956|183009352|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.||||<0.001
91560255|NCT01393964|183009357|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.096||||0.704|TWO_SIDED|90.0|86.983|124.576|||ANOVA|||The reference arm is NRF participants.||124.576|86.983|0.704
91560256|NCT01393964|183009357|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.454||||0.965|TWO_SIDED|90.0|84.453|119.488|||ANOVA|||The reference arm is NRF participants.||119.488|84.453|0.965
91560257|NCT01393964|183009358|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|126.596||||0.164|TWO_SIDED|90.0|95.52|167.783|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||167.783|95.52|0.164
91560258|NCT01393964|183009358|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|116.123||||0.355|TWO_SIDED|90.0|88.458|152.439|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||152.439|88.458|0.355
91560259|NCT01393964|183009358|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|129.858||||0.228|TWO_SIDED|90.0|90.366|186.609|||ANOVA|||AUC (INF). The reference arm is NRF participants.||186.609|90.366|0.228
91560260|NCT01393964|183009358|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|110.4||||0.642|TWO_SIDED|90.0|76.825|158.647|||ANOVA|||AUC(INF). The reference arm is NRF participants.||158.647|76.825|0.642
91560261|NCT01918033|183009388|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.09||||0.661|TWO_SIDED|95.0|-0.49|0.31|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.31|-0.49|0.661
91560262|NCT01918033|183009388|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.707|TWO_SIDED|95.0|-0.48|0.32|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.32|-0.48|0.707
91560263|NCT01918033|183009391|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.48||||0.01|TWO_SIDED|95.0|-0.84|-0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.11|-0.84|0.010
91560264|NCT01918033|183009391|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.46||||0.013|TWO_SIDED|95.0|-0.82|-0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.10|-0.82|0.013
91560265|NCT01918033|183009391|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.569|TWO_SIDED|95.0|-0.29|0.53|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.53|-0.29|0.569
91560266|NCT01918033|183009391|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.09||||0.685|TWO_SIDED|95.0|-0.33|0.5|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.50|-0.33|0.685
91560267|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.547|TWO_SIDED|95.0|-0.15|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.08|-0.15|0.547
91560268|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.067|TWO_SIDED|95.0|-0.22|0.01|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.01|-0.22|0.067
91560269|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.895|TWO_SIDED|95.0|-0.15|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.13|-0.15|0.895
91560270|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.627|TWO_SIDED|95.0|-0.1|0.17|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.17|-0.10|0.627
91560271|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.535|TWO_SIDED|95.0|-0.09|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.09|0.535
91560272|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.557|TWO_SIDED|95.0|-0.1|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.10|0.557
91768805|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-9.2||||0.417|TWO_SIDED|95.0|-31.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.9|-31.3|0.417
91560273|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.11||||0.119|TWO_SIDED|95.0|-0.25|0.03|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.03|-0.25|0.119
91560274|NCT01918033|183009392|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.403|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.08|-0.20|0.403
91768806|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-20.2||||0.125|TWO_SIDED|95.0|-46.7|6.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||6.2|-46.7|0.125
91768807|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
91768808|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
91560275|NCT01918033|183009393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.376|TWO_SIDED|95.0|-0.2|0.07|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.07|-0.20|0.376
91560276|NCT01918033|183009393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.714|TWO_SIDED|95.0|-0.16|0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.11|-0.16|0.714
91560277|NCT01918033|183009393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.725|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.725
91560278|NCT01918033|183009393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.708|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.708
91768809|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-18.3||||0.2|TWO_SIDED|95.0|-46.1|9.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||9.6|-46.1|0.200
91768810|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||50.8|-7.9|0.177
91768811|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|22.4||||0.074|TWO_SIDED|95.0|-1.4|46.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.2|-1.4|0.074
91560279|NCT01918033|183009393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.68|TWO_SIDED|95.0|-0.1|0.16|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.16|-0.10|0.680
91560280|NCT01918033|183009393|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.06||||0.373|TWO_SIDED|95.0|-0.07|0.19|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.19|-0.07|0.373
91560281|NCT01918033|183009394|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.849|TWO_SIDED|95.0|-0.14|0.12|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.12|-0.14|0.849
91560282|NCT01918033|183009394|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.26|TWO_SIDED|95.0|-0.2|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.06|-0.20|0.260
91768812|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
91768813|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.8|-7.9|0.177
91560283|NCT01918033|183009395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.826||||0.34|TWO_SIDED|95.0|0.558|1.223|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.223|0.558|0.340
91768814|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|12.1||||0.343|TWO_SIDED|95.0|-12.7|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.8|-12.7|0.343
91560284|NCT01918033|183009395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.755||||0.159|TWO_SIDED|95.0|0.51|1.116|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.116|0.510|0.159
91560285|NCT01918033|183009396|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.705|TWO_SIDED|95.0|-0.09|0.14|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.14|-0.09|0.705
91560286|NCT01918033|183009396|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.02||||0.782|TWO_SIDED|95.0|-0.13|0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.10|-0.13|0.782
91560287|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.175|TWO_SIDED|95.0|-0.24|0.04|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.04|-0.24|0.175
91560288|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.12||||0.098|TWO_SIDED|95.0|-0.26|0.02|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.02|-0.26|0.098
91560289|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.13|TWO_SIDED|95.0|-0.04|0.27|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.27|-0.04|0.130
91560290|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.375|TWO_SIDED|95.0|-0.08|0.22|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.22|-0.08|0.375
91560291|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.08||||0.285|TWO_SIDED|95.0|-0.07|0.24|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.24|-0.07|0.285
91560292|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.05||||0.49|TWO_SIDED|95.0|-0.1|0.21|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.21|-0.10|0.490
91560293|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.345|TWO_SIDED|95.0|-0.23|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.08|-0.23|0.345
91560294|NCT01918033|183009397|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.699|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.13|-0.19|0.699
91560295|NCT01918033|183009398|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.414|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.08|-0.20|0.414
91560296|NCT01918033|183009398|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.281|TWO_SIDED|95.0|-0.22|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.06|-0.22|0.281
91560297|NCT04679675|183009399|SUPERIORITY||Risk Ratio (RR)|1.3||||0.05|TWO_SIDED|95.0|1.23|1.36|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Direct-Mail versus Education analysis.||1.36|1.23|0.05
91560298|NCT04679675|183009399|SUPERIORITY||Risk Ratio (RR)|1.07||||0.05|TWO_SIDED|95.0|1.02|1.12|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Opt-In versus Education analysis.||1.12|1.02|.05
91560299|NCT04679675|183009399|SUPERIORITY||Risk Ratio (RR)|1.9||||0.05|TWO_SIDED|95.0|1.68|2.16|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Overdue (population):Direct-Mail versus Education analysis.||2.16|1.68|.05
91560300|NCT04679675|183009399|SUPERIORITY||Risk Ratio (RR)|1.14||||0.05|TWO_SIDED|95.0|1.03|1.25|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Unknown (population):Opt-In versus Education analysis.||1.25|1.03|.05
91560301|NCT01702259|183009415|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91560302|NCT01702259|183009416|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91560303|NCT01702259|183009417|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91560304|NCT01702259|183009418|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91560305|NCT00687297|183009429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||1||95.0|||||Fisher Exact|||Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.||||1.00
91560306|NCT00687297|183009430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.02|TWO_SIDED|95.0|1.07|2.07||p-value from Wald test|Regression, Cox|The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)||There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.||2.07|1.07|0.02
91560307|NCT01494467|183009433|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91560308|NCT01494467|183009434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.22|||<|0.001|TWO_SIDED|95.0|-10.18|-6.25|||ANCOVA|||||-6.25|-10.18|<0.001
91560309|NCT01494467|183009435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91560310|NCT00700999|183009473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_DEVIATION|0.9||0.001|TWO_SIDED|95.0|-1.38|-0.45|||t-test, 2 sided|||||-0.45|-1.38|.001
91560311|NCT00700999|183009473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|1.78||0.869|TWO_SIDED|95.0|-0.84|0.99|||t-test, 2 sided|||||.99|-.84|.869
91768815|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||20.3|-36.1|0.585
91560312|NCT00244751|183009474|SUPERIORITY_OR_OTHER|||||||0.3608|||||||reduced regression model|||||||0.3608
91560313|NCT00244751|183009474|SUPERIORITY_OR_OTHER|||||||0.3575|||||||reduced regression model|||||||0.3575
91560314|NCT00244751|183009475|SUPERIORITY_OR_OTHER|||||||0.9157|||||||reduced regression model|||||||0.9157
91768816|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-30.0||||0.539|TWO_SIDED|95.0|-50.1|-9.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-9.9|-50.1|0.539
91560315|NCT00244751|183009475|SUPERIORITY_OR_OTHER|||||||0.9501|||||||reduced regression model|||||||0.9501
91560316|NCT00244751|183009476|SUPERIORITY_OR_OTHER|||||||0.6483|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (fibrosis)||||0.6483
91560317|NCT00244751|183009476|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (necrosis)||||0.1776
91560318|NCT02077374|183009502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.0195|TWO_SIDED|95.0|-30.7|-2.5|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo||-2.5|-30.7|0.0195
91560319|NCT02077374|183009504|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.8||||0.8724|TWO_SIDED|95.0|-14.5|11.2|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo||11.2|-14.5|0.8724
91560320|NCT02077374|183009505|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.0||||0.1149|TWO_SIDED|95.0|-336.0|55.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo||55|-336|0.1149
91560321|NCT02077374|183009506|SUPERIORITY_OR_OTHER||Median Difference (Net)|-250.0||||0.1365|TWO_SIDED|95.0|-590.0|63.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo||63|-590|0.1365
91560322|NCT02077374|183009507|SUPERIORITY_OR_OTHER||Median Difference (Net)|-327.0||||0.0471|TWO_SIDED|95.0|-628.0|-7.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo||-7|-628|0.0471
91560323|NCT04604652|183009519|OTHER||||||=|0.077|||||||t-test, 1 sided|||A t-test was performed to test for the percent change from baseline to Week 12. This analysis was based on observed data without imputation. Testing was one sided using a 5% alpha level. No multiplicity adjustment was used, and the p-values reported for the endpoints were descriptive in nature.||||=0.077
91560324|NCT00068107|183009530|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||eGFR measured pre-study was compared to eGFR during the study||||0.01
91560325|NCT00068107|183009530|SUPERIORITY_OR_OTHER||Average Delay in time to ESRD|166.0|||||TWO_SIDED|95.0|8.4|323.8|||||The average delay in end stage renal disease (ESRD) calculated from the eGFR values and represents the estimated difference in time to ESRD between Relagal administered every 2 weeks and Relagal administered weekly. Units = months|||323.8|8.4|
91560326|NCT03989232|183009536|SUPERIORITY||Treatment difference|-0.23||||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.||-0.11|-0.36|0.0003
91560327|NCT03989232|183009536|SUPERIORITY||Treatment difference|-0.18||||0.0098|TWO_SIDED|95.0|-0.31|-0.04|||ANCOVA|||In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.||-0.04|-0.31|0.0098
91560328|NCT01930188|183009547|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.91|||Mixed Models Analysis|Post-baseline responses analysed with mixed model for repeated measurements-treatment \& country (fixed) \& baseline (covariate) all nested within visit||||-0.91|-1.21|<0.0001
91560329|NCT01930188|183009547|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.62|||Mixed Models Analysis|Analysis done with mixed model for repeated measurements (treatment \& country as fixed factors \& baseline value as covariate) all nested within visit||||-0.62|-1.21|<0.0001
91560330|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-0.9|9.2||||||Tx 1 - SBP (Unadjusted)||9.2|-0.9|
91560331|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.4|5.3||||||Tx 1 - DBP (Unadjusted)||5.3|-0.4|
91560332|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.2|5.6||||||Wk 3 - SBP (Unadjusted)||5.6|-6.2|
91560333|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-4.0|3.5||||||Wk 3 - DBP (Unadjusted)||3.5|-4.0|
91560334|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.9|8.9||||||Wk 6 - SBP (Unadjusted)||8.9|-1.9|
91560335|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-2.1|5.0||||||Wk 6 - DBP (Unadjusted)||5.0|-2.1|
91560336|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-0.4|9.8||||||Tx 1 - SBP (Adjusted)||9.8|-0.4|
91560337|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|0.6|6.5||||||Tx 1 - DBP (Adjusted)||6.5|0.6|
91560338|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-5.0|6.9||||||Wk 3 - SBP (Adjusted)||6.9|-5.0|
91560339|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||Wk 3 - DBP (Adjusted)||4.9|-2.8|
91560340|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-0.4|10.0||||||Wk 6 - SBP (Adjusted)||10.0|-0.4|
91560341|NCT01020435|183009566|OTHER||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-1.2|5.8||||||Wk 6 - DBP (Adjusted)||5.8|-1.2|
91560342|NCT00346398|183009569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.28|TWO_SIDED|95.0|0.5|10.5||Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||10.5|0.5|0.28
91560343|NCT00346398|183009570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.2|6.1||Odds Ratios are calculated using unadjusted exact logistic regression with mid p-value to adjust for the discreteness of the distribution|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||6.1|0.2|0.85
91560344|NCT00346398|183009571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.28|TWO_SIDED|95.0|0.6|5.6||P-value is calculated using a log-rank test|Regression, Logistic||Hazard ratio and 95% confidence intervals are calculated using an unadjusted Cox regression|||5.6|0.6|0.28
91560345|NCT02607956|183009572|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-3.5|||||TWO_SIDED|95.002|-7.9|1.0|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.0|-7.9|
91560346|NCT02607956|183009572|SUPERIORITY|||||||0.12|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.12
91560347|NCT02607956|183009573|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-7.9|3.2|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.2|-7.9|
91768817|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-15.7||||0.277|TWO_SIDED|95.0|-40.8|9.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||9.3|-40.8|0.277
91768818|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-15.7||||0.422|TWO_SIDED|95.0|-42.9|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||11.5|-42.9|0.422
91560348|NCT02607956|183009573|OTHER|||||||0.41|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.41
91560349|NCT02607956|183009574|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.8|3.9|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.9|-7.8|
91560350|NCT02607956|183009574|OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.52
91560351|NCT02607956|183009575|OTHER||Difference in Percentages|-3.9|||||TWO_SIDED|95.0|-9.4|1.5|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.5|-9.4|
91560352|NCT02607956|183009575|OTHER|||||||0.16|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.16
91768819|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
91560353|NCT02607956|183009576|OTHER||Difference in Percentages|-2.5|||||TWO_SIDED|95.0|-8.8|3.8|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.8|-8.8|
91560354|NCT02607956|183009576|OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.44
91560355|NCT02607956|183009577|OTHER||Difference in Percentages|-1.1|||||TWO_SIDED|95.0|-7.4|5.3|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.3|-7.4|
91560356|NCT02607956|183009577|OTHER|||||||0.74|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.74
91560357|NCT02607956|183009578|OTHER||Difference in LSM|0.08||||0.081|TWO_SIDED|95.0|-0.01|0.17|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.17|-0.01|0.081
91560358|NCT02607956|183009579|OTHER||Difference in LSM|0.06||||0.18|TWO_SIDED|95.0|-0.03|0.15|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.15|-0.03|0.18
91560359|NCT02607956|183009580|OTHER||Difference in LSM|0.09||||0.054|TWO_SIDED|95.0|0.0|0.18|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.18|0.00|0.054
91560360|NCT02607956|183009581|OTHER||Difference in LSM|-23.0||||0.096|TWO_SIDED|95.0|-49.0|4.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||4|-49|0.096
91560361|NCT02607956|183009582|OTHER||Difference in LSM|-47.0||||0.008|TWO_SIDED|95.0|-81.0|-12.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||-12|-81|0.008
91560362|NCT02607956|183009583|OTHER||Difference in LSM|-14.0||||0.48|TWO_SIDED|95.0|-52.0|25.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||25|-52|0.48
91560363|NCT00960206|183009605|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.0832
91560364|NCT00960206|183009605|SUPERIORITY_OR_OTHER|||||||0.1657|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.1657
91560365|NCT00960206|183009606|SUPERIORITY_OR_OTHER|||||||0.3701|||||||Fisher Exact|||To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have \< 80 for all three arms||||0.3701
91560366|NCT00960206|183009608|SUPERIORITY_OR_OTHER|||||||0.6011|||||||Fisher Exact|||Compare the # of cases at 10 years satisfied with their total hip replacement for all three groups||||0.6011
91560367|NCT00960206|183009608|SUPERIORITY_OR_OTHER|||||||0.206|||||||Fisher Exact|||Compare the # of cases at 10 years for having pain in their hip for all three groups||||0.2060
91560368|NCT01075152|183009609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.73||||0.03|TWO_SIDED|95.0|1.06|2.82||A Lan-DeMets spending function analog of the O'Brien-Fleming boundaries was proposed to control the type-I error resulting from multiple interim analyses.|Regression, Cox||Hazard Ratio describes the risk of earlier HIV therapy in comparison to deferred HIV therapy initiation as the reference group.|"We compared the randomization arms for the primary endpoint of survival using time-to-event methods of Cox proportional hazards models by the intention-to-treat principle, based on two-sided type-I error with alpha=0.05.~The trial was statistically powered to detect a 25% relative survival benefit (15% absolute benefit) with 90% power and overall two-sided alpha=0.05 with an intended sample size of 500 participants. The trial was halted early by the Data and Safety Monitoring Board."||2.82|1.06|0.03
91560369|NCT01075152|183009610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.32
91560370|NCT01075152|183009611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.06
91560371|NCT01075152|183009612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.98
91768820|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
91560372|NCT01075152|183009613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.66||||0.04|TWO_SIDED|95.0|1.03|2.68|||Regression, Cox|||We compared the randomization arms for survival using time-to-event methods of Cox proportional hazards models.||2.68|1.03|0.04
91560373|NCT01075152|183009614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.26
91560374|NCT01075152|183009615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.23
91560375|NCT01075152|183009616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||repeated measure analysis|||The overall change from baseline in Karnofsky performance status scores was compared between groups via a repeated measure analysis, unstructured covariance matrix, adjusted for baseline value.||||0.34
91560376|NCT01075152|183009617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Regression, Linear|a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance||To describe early fungicidal activity, a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance of log10 colony forming units (CFU) of Cryptococcus, per mL of CSF per day, for all participants with \>2 cultures obtained.||||0.44
91560377|NCT01075152|183009618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||This is the interaction p-value for CSF white cell count at randomization (implying there is a statistical difference in the outcome by arm based on this parameter).|Regression, Cox|||Pre-specified subgroups formed by baseline characteristics were compared for 26 week survival with models including an interaction term between treatment arm and subgroup.||||0.02
91768821|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||5.4|-41.1|0.364
91560378|NCT01079949|183009622|SUPERIORITY_OR_OTHER|||||||0.5739||95.0|||||Wilcoxon two sample test|||||||0.5739
91560379|NCT01079949|183009627|SUPERIORITY_OR_OTHER|||||||0.1734||95.0|||||Wilcoxon two sample test|||||||0.1734
91560380|NCT01079949|183009628|SUPERIORITY_OR_OTHER|||||||0.0642||95.0|||||Wilcoxon two sample test|||||||0.0642
91560381|NCT01079949|183009632|SUPERIORITY_OR_OTHER|||||||0.408||95.0|||||Wilcoxon two sample test|||||||0.4080
91560382|NCT01079949|183009635|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Wilcoxon two sample test|||||||0.0648
91560383|NCT01079949|183009636|SUPERIORITY_OR_OTHER|||||||0.6799||95.0|||||ANOVA|||||||0.6799
91560384|NCT01079949|183009637|SUPERIORITY_OR_OTHER|||||||0.0634||95.0|||||Wilcoxon two sample test|||||||0.0634
91560385|NCT01079949|183009639|SUPERIORITY_OR_OTHER|||||||0.0166||95.0|||||Wilcoxon two sample test|||||||0.0166
91560386|NCT01079949|183009640|SUPERIORITY_OR_OTHER|||||||0.8812||95.0|||||ANOVA|||||||0.8812
91560387|NCT05066230|183009641|SUPERIORITY||Difference of weighted percentages|39.7|||<|0.0001|TWO_SIDED|95.02|31.3|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||48.1|31.3|<0.0001
91560388|NCT05066230|183009642|SUPERIORITY||Difference of weighted percentages|-18.7|||<|0.0001|TWO_SIDED|95.02|-26.2|-11.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-11.2|-26.2|<0.0001
91560389|NCT05066230|183009643|SUPERIORITY||Difference of weighted percentages|5.6||||0.0058|TWO_SIDED|95.02|1.6|9.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53), HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||9.5|1.6|0.0058
91560390|NCT05066230|183009644|SUPERIORITY||Difference of weighted percentages|-6.5||||0.0149|TWO_SIDED|95.02|-11.8|-1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-1.3|-11.8|0.0149
91560391|NCT00307489|183009656|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||.544
91560392|NCT00307489|183009657|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.208
91560393|NCT00307489|183009658|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||Controlling for baseline HBeAg and prior lamivudine use.|van Elteren|||||||0.712
91560394|NCT00307489|183009659|SUPERIORITY_OR_OTHER|||||||0.988||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.988
91560395|NCT00307489|183009660|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||Controlling for baseline HBeAg status and prior lamivudine use|Cochran-Mantel-Haenszel|||||||0.423
91560396|NCT00307489|183009661|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.109
91560397|NCT00307489|183009662|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Cochran-Mantel-Haenszel|Controlling for baseline HBeAg and prior lamivudine use.||||||0.952
91560398|NCT00307489|183009663|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.655
91560399|NCT00307489|183009664|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
91560400|NCT00307489|183009665|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
91560401|NCT00307489|183009666|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.103
91560402|NCT00307489|183009667|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.999
91560403|NCT00307489|183009668|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.781
91560404|NCT00307489|183009669|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.936
91560405|NCT00307489|183009670|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.784
91560406|NCT00307489|183009671|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.703
91560407|NCT00307489|183009672|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
91560408|NCT00307489|183009673|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
91560409|NCT00307489|183009674|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|||||||0.878
91560410|NCT01301183|183009752|OTHER|ANCOVA||||||0.109||||||Adjusted for baseline age, height, bone density and 12-month weight change|ANCOVA|||||||.109
91560411|NCT01301183|183009753|OTHER|||||||0.344||||||Adjusted for age, height, baseline trabecular number and change in weight over 12 months|ANCOVA|||||||0.344
91560412|NCT00759681|183009780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.0538||0.05|TWO_SIDED|95.0|0.103|0.314|||Exact binomial confidence limit|Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.||Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.||0.314|0.103|0.05
91560413|NCT00759681|183009781|NON_INFERIORITY_OR_EQUIVALENCE|Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%.|Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.0671||0.05|ONE_SIDED|95.0||-0.003|||Exact binomial confidence limit|Safety: 95% confidence limits of the difference between groups, and ensuring that the upper limit of the difference was less than or equal to 15%.|The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.|The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.||-0.003||0.05
91560414|NCT02410278|183009783|SUPERIORITY||Odds Ratio (OR)|3.931||||0.0617|TWO_SIDED|95.0|0.938|20.832|||weighted logistic regression model|||Odds ratio is the odds of an event in the Montelukast treatment group divided by the odds of an event in the placebo treatment group. P-value is from the likelihood ratio test that the odds ratio is 1. CI = profile likelihood confidence interval.||20.832|0.938|0.0617
91560415|NCT02410278|183009784|SUPERIORITY||adjusted mean difference|0.084||||0.3753|TWO_SIDED|95.0|-0.104|0.273|||ANCOVA|||Results are obtained from an ANCOVA model for comparing average change of the GSRS score in the two treatment groups, adjusted for age, weight and baseline GSRS score. Weights, defined as the proportions of days with GSRS score recorded during the Day 1 - Day 10 period are applied to adjust for missing data.||0.273|-0.104|0.3753
91560416|NCT02410278|183009785|SUPERIORITY||adjusted mean difference|0.081||||0.0376|TWO_SIDED|95.0|0.005|0.158|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Week 10.||0.158|0.005|0.0376
91560417|NCT02410278|183009786|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.7952|TWO_SIDED|95.0|0.554|2.164|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||2.164|0.554|0.7952
91560418|NCT02410278|183009787|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.8328|TWO_SIDED|95.0|0.563|1.589|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||1.589|0.563|0.8328
91560419|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.115||||0.1743|TWO_SIDED|95.0|-0.052|0.283|||Repeated measures model|||Change from Day 1 to Week 1: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.283|-0.052|0.1743
91560420|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.079||||0.2677|TWO_SIDED|95.0|-0.063|0.221|||Repeated measures model|||Change from Day 1 to Week 2: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.221|-0.063|0.2677
91560421|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.085||||0.1788|TWO_SIDED|95.0|-0.04|0.211|||Repeated measures model|||Change from Day 1 to Week 3: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.211|-0.040|0.1788
91560422|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.1||||0.0866|TWO_SIDED|95.0|-0.015|0.216|||Repeated measures model|||Change from Day 1 to Week 4: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.216|-0.015|0.0866
91560423|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.1||||0.0509|TWO_SIDED|95.0|0.0|0.201|||Repeated measures model|||Change from Day 1 to Week 5: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.201|-0.000|0.0509
91560424|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.088||||0.0649|TWO_SIDED|95.0|-0.006|0.182|||Repeated measures model|||Change from Day 1 to Week 6: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.182|-0.006|0.0649
91560425|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.088||||0.0479|TWO_SIDED|95.0|0.001|0.176|||Repeated measures model|||Change from Day 1 to Week 7: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.176|0.001|0.0479
91560426|NCT02410278|183009788|SUPERIORITY||adjusted mean difference|0.082||||0.054|TWO_SIDED|95.0|-0.001|0.166|||Repeated measures model|||Change from Day 1 to Week 8: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.166|-0.001|0.0540
91560427|NCT02410278|183009789|SUPERIORITY||adjusted mean difference|0.129||||0.2469|TWO_SIDED|95.0|-0.092|0.349|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight (kg) and baseline GSRS score, and has unstructured variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Day 3.||0.349|-0.092|0.2469
91560428|NCT02410278|183009790|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
91560429|NCT02410278|183009791|SUPERIORITY|||||||1|||||||Fisher's Exact|||||||1.0000
91560430|NCT02410278|183009792|SUPERIORITY|||||||0.2604|||||||Chi-squared|||||||0.2604
91560431|NCT02584257|183009793|SUPERIORITY||Least Square Means Differences|3.171|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|2.732|3.61||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||3.610|2.732|<0.0001
91560432|NCT02584257|183009793|SUPERIORITY||Least Square Means Differences|3.824|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|3.384|4.263||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.263|3.384|<0.0001
91560433|NCT02584257|183009793|SUPERIORITY||Least Square Means Differences|3.32|STANDARD_ERROR_OF_MEAN|0.241|<|0.0001|TWO_SIDED|95.0|2.876|3.764||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL.||||3.764|2.876|<0.0001
91560434|NCT02584257|183009793|SUPERIORITY||Least Square Means Differences|3.872|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|3.43|4.315||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.315|3.430|<0.0001
91560435|NCT02584257|183009793|EQUIVALENCE|A blinded interim analysis was performed after 60 patients completed all treatment visits which determined that 80 subjects would be sufficient to complete the study with 90% power.|Frel|1.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.93|1.48|||||Frel is the relative bioavailability of the test versus reference product. The CI was a bias corrected and accelerated CI based on a bootstrapping procedure. The FDA acceptable CI was between 0.67 and 1.50.|An Emax model was developed and the 90% confidence interval of Frel was a bias corrected accelerated confidence interval based on a bootstrapping procedure. The bootstrapping procedure used for this analysis was residual resampling. The Per-Protocol population was the primary population for bioequivalence analysis. Patients in the PP population must have completed at least 2 treatment periods with valid PC20FEV1 measurements and had no major protocol deviations within those intervals.||1.48|0.93|
91560436|NCT01137682|183009847|SUPERIORITY||Odds Ratio (OR)|16.63||||0.0006|TWO_SIDED|95.0|3.32||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||3.32|0.0006
91560437|NCT01137682|183009847|SUPERIORITY||Odds Ratio (OR)|23.03|||<|0.0001|TWO_SIDED|95.0|4.72||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||4.72|<0.0001
91560438|NCT02009332|183009862|OTHER||maximum deliverable dose (MDD)|400.0|||||TWO_SIDED||||||||Maximum deliverable dose (MDD) was not reached in the Phase 1 study as no DLTs were observed in any of the dose groups up to ABI-009 400 mg/week.|||||
91560439|NCT03386344|183009887|SUPERIORITY||Difference in Least Squares (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.649|-0.25|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.250|-0.649|<0.0001
91560440|NCT03386344|183009887|SUPERIORITY||Difference in LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.634|-0.235|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.235|-0.634|<0.0001
91560441|NCT03386344|183009888|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.423||0.5707|TWO_SIDED|95.0|-1.07|0.59|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.590|-1.070|0.5707
91560442|NCT03386344|183009888|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.419||0.7247|TWO_SIDED|95.0|-0.969|0.674|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.674|-0.969|0.7247
91560443|NCT03386344|183009889|SUPERIORITY||Difference in LS Means|0.14|STANDARD_ERROR_OF_MEAN|0.308||0.6454|TWO_SIDED|95.0|-0.462|0.745|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.745|-0.462|0.6454
91560444|NCT03386344|183009889|SUPERIORITY||Difference in LS Means|0.19|STANDARD_ERROR_OF_MEAN|0.308||0.5289|TWO_SIDED|95.0|-0.41|0.798|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.798|-0.410|0.5289
91560445|NCT03386344|183009890|SUPERIORITY||Difference in LS Means|0.75|STANDARD_ERROR_OF_MEAN|0.462||0.105|TWO_SIDED|95.0|-0.157|1.654|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.654|-0.157|0.1050
91560446|NCT03386344|183009890|SUPERIORITY||Difference in LS Means|0.32|STANDARD_ERROR_OF_MEAN|0.46||0.4804|TWO_SIDED|95.0|-0.577|1.226|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.226|-0.577|0.4804
91560447|NCT03386344|183009891|SUPERIORITY||Difference in LS Means|-1.91|STANDARD_ERROR_OF_MEAN|0.336|<|0.0001|TWO_SIDED|95.0|-2.568|-1.252|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.252|-2.568|<0.0001
91560448|NCT03386344|183009891|SUPERIORITY||Difference in LS Means|-1.7|STANDARD_ERROR_OF_MEAN|0.335|<|0.0001|TWO_SIDED|95.0|-2.36|-1.046|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.046|-2.360|<0.0001
91560449|NCT03386344|183009892|SUPERIORITY||Difference in LS Means|-18.891|STANDARD_ERROR_OF_MEAN|4.5766|<|0.0001|TWO_SIDED|95.0|-27.8605|-9.9205|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-9.9205|-27.8605|<0.0001
91560450|NCT03386344|183009892|SUPERIORITY||Difference in LS Means|-21.333|STANDARD_ERROR_OF_MEAN|4.5902|<|0.0001|TWO_SIDED|95.0|-30.3294|-12.336|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-12.3360|-30.3294|<0.0001
91560451|NCT03386344|183009893|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|1.48||0.5864|TWO_SIDED|95.0|-3.705|2.095|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||2.095|-3.705|0.5864
91560452|NCT03386344|183009893|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|1.478||0.4315|TWO_SIDED|95.0|-4.058|1.734|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||1.734|-4.058|0.4315
91560453|NCT03386344|183009894|SUPERIORITY||Percentage Difference|10.5||||0.0172|TWO_SIDED|95.0|1.78|19.23|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||19.23|1.78|0.0172
91560454|NCT03386344|183009894|SUPERIORITY||Percentage Difference|12.0||||0.0076|TWO_SIDED|95.0|3.23|20.86|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||20.86|3.23|0.0076
91560455|NCT01077284|183009896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.001
91560456|NCT01077284|183009896|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.003
91560457|NCT01077284|183009897|SUPERIORITY_OR_OTHER|||||||0.13||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.130
91560458|NCT01077284|183009897|SUPERIORITY_OR_OTHER|||||||0.348||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.348
91560459|NCT01077284|183009898|SUPERIORITY_OR_OTHER|||||||0.403||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.403
91560460|NCT01077284|183009898|SUPERIORITY_OR_OTHER|||||||0.413||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.413
91560461|NCT01077284|183009899|SUPERIORITY_OR_OTHER|||||||0.5535||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.5535
91560462|NCT01077284|183009899|SUPERIORITY_OR_OTHER|||||||0.94||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.9400
91560463|NCT02791308|183009900|EQUIVALENCE|Proportion of Subjects with Treatment Success at Visit 4/Day 15|Other|0.407|||||TWO_SIDED|90.0|-15.57|3.53||||||Percentage of Subjects with Treatment Success at Visit 4/Day 15||3.53|-15.57|
91560464|NCT00674765|183009916|SUPERIORITY_OR_OTHER|||||||0.388|||||||t-test, 2 sided|t=.87||||||.388
91768822|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
91768823|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
91768824|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
91768825|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Clinical non-responders, Week 44||3.1|-23.1|1.000
91560465|NCT02379078|183009924|SUPERIORITY|||||||0.0246|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.0246
91560466|NCT02379078|183009925|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
91560467|NCT02379078|183009926|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
91560468|NCT02379078|183009927|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||||||0.468
91560469|NCT02379078|183009928|SUPERIORITY|||||||0.6|||||||ANOVA|||||||0.60
91560470|NCT01133678|183009973|OTHER|||||||0.19||||||A recommendation to stop the trial early was stipulated if the conditional power at the interim analysis (after 50 patients) was \<10% using a stochastic curtailment approach.. This would occur if the interim test statistic is t \< -0.287.|t-test, 2 sided|t-statistic = -1.330, exceeding threshold (\<-0.287, conditional power\<10%) for early termination.||||||0.190
91560471|NCT00424476|183010039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0006||95.0|1.3|2.59||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.59|1.30|0.0006
91560472|NCT00424476|183010039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.0129|TWO_SIDED|95.0|1.1|2.19||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).|Regression, Logistic|Adjusted for baseline stratification factors.||||2.19|1.10|0.0129
91560473|NCT00424476|183010040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.0024|TWO_SIDED|95.0|1.21|2.41|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.41|1.21|0.0024
91560474|NCT00424476|183010040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0189|TWO_SIDED|95.0|1.07|2.14|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.14|1.07|0.0189
91560475|NCT00424476|183010041|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.0003
91560476|NCT00424476|183010041|SUPERIORITY_OR_OTHER|||||||0.2712||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.2712
91768826|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-5.2||||0.606|TWO_SIDED|95.0|-21.2|10.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.8|-21.2|0.606
91560477|NCT00424476|183010042|SUPERIORITY_OR_OTHER|||||||0.887|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8870
91560478|NCT00424476|183010042|SUPERIORITY_OR_OTHER|||||||0.8127|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8127
91560479|NCT00424476|183010043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0526|TWO_SIDED|95.0|0.99|3.08|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.08|0.99|0.0526
91560480|NCT00424476|183010043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0252|TWO_SIDED|95.0|1.08|3.31|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.31|1.08|0.0252
91560481|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.81|0.99|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.99|0.81|
91768827|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-2.9||||1|TWO_SIDED|95.0|-21.7|16.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||16.0|-21.7|1.000
91560482|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.02|||||TWO_SIDED|95.0|0.93|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.93|
91560483|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.14|||||TWO_SIDED|95.0|1.03|1.27|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.27|1.03|
91560484|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.88|||||TWO_SIDED|95.0|0.78|0.98|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.98|0.78|
91768828|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
91768829|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
91768830|NCT02365649|183425724|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
91560485|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.1|0.88|
91560486|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.12|||||TWO_SIDED|95.0|1.0|1.26|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.26|1.0|
91560487|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.04||||||95.0|0.88|1.23|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.88|
91560488|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.96||||||95.0|0.81|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.81|
91560489|NCT00657709|183010054|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.92|||||TWO_SIDED|95.0|0.78|1.08|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||"The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0)."||1.08|0.78|
91768831|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|17.5||||0.633|TWO_SIDED|95.0|-13.0|48.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||48.0|-13.0|0.633
91768832|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|30.0||||0.0024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.0024
91560490|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval \[-10%, 10%\].||1|-1|
91560491|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
91560492|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
91560493|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-1|
91560494|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
91560495|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
91560496|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for NZ98/254 strain.|Percentage group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval \[-10%, 10%\].||8|-2|
91560497|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for NZ 98/254 strain.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0|||Miettinen and Nurminen|The lot-to-lot difference in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval \[-10%, 10%\].||4|-6|
91768833|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||34.8|-34.8|1.000
91560498|NCT00657709|183010056|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided (5% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for NZ98/254 strain.|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-9|
91560499|NCT00657709|183010059|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.84|||||TWO_SIDED|95.0|0.76|0.94|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.94|0.76|
91560500|NCT00657709|183010059|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.77|||||TWO_SIDED|95.0|0.67|0.89|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least square means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.89|0.67|
91560501|NCT00657709|183010059|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.8|||||TWO_SIDED|95.0|0.71|0.91|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIS.||Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.91|0.71|
91560502|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-1|
91560503|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-12|
91560504|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-2|
91560505|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-9|
91560506|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-5|
91560507|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||-1|-11|
91560508|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-4|
91560509|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-5.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%||-1|-5|
91560510|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.||1|-3|
91560511|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.||7|-7|
91560512|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-4.0|0.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.||0|-4|
91560513|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|2.0|||||TWO_SIDED|95.0|-4.0|8.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.||8|-4|
91560514|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa\_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.||1|-2|
91560515|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.||3|-4|
91560516|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.||1|-3|
91560517|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.||4|-3|
91768834|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-39.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.8|-39.8|1.000
91768835|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
91560518|NCT00657709|183010060|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.||2|-8|
91560519|NCT00657709|183010061|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||4|-9|
91560520|NCT00657709|183010061|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-9.0|||||TWO_SIDED|95.0|-16.0|-3.0|||Miettinen and Nurminen|||Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||-3|-16|
91560521|NCT00657709|183010061|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||2|-7|
91560522|NCT03122860|183010065|SUPERIORITY||Median Difference (Final Values)|-0.46||||0.179|TWO_SIDED|95.0|-1.13|0.21|||ANCOVA|||||0.21|-1.13|0.179
91560523|NCT03122860|183010065|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.031|TWO_SIDED|95.0|-1.34|-0.06|||ANCOVA|||||-0.06|-1.34|0.031
91560524|NCT03122860|183010065|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.675|TWO_SIDED|95.0|-0.81|0.52|||ANCOVA|||||0.52|-0.81|0.675
91560525|NCT03122860|183010065|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.022|TWO_SIDED|95.0|-1.51|-0.12|||ANCOVA|||||-0.12|-1.51|0.022
91560526|NCT03122860|183010065|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||ANCOVA|||||0.59|-0.79|0.780
91560527|NCT03122860|183010066|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.612|TWO_SIDED|95.0|-8.32|4.91|||ANCOVA|||||4.91|-8.32|0.612
91560528|NCT03122860|183010066|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.223|TWO_SIDED|95.0|-10.47|2.46|||ANCOVA|||||2.46|-10.47|0.223
91768836|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||15.1|-55.1|0.384
91560529|NCT03122860|183010066|SUPERIORITY||Mean Difference (Final Values)|1.84||||0.59|TWO_SIDED|95.0|-4.89|8.57|||ANCOVA|||||8.57|-4.89|0.590
91560530|NCT03122860|183010066|SUPERIORITY||Mean Difference (Final Values)|-7.36||||0.031|TWO_SIDED|95.0|-14.03|-0.69|||ANCOVA|||||-0.69|-14.03|0.031
91560531|NCT03122860|183010066|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.403|TWO_SIDED|95.0|-9.7|3.92|||ANCOVA|||||3.92|-9.70|0.403
91560532|NCT03122860|183010067|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.432|TWO_SIDED|95.0|-9.04|3.88|||ANCOVA|||||3.88|-9.04|0.432
91560533|NCT03122860|183010067|SUPERIORITY||Mean Difference (Final Values)|-4.34||||0.18|TWO_SIDED|95.0|-10.69|2.02|||ANCOVA|||||2.02|-10.69|0.180
91560534|NCT03122860|183010067|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.718|TWO_SIDED|95.0|-5.33|7.72|||ANCOVA|||||7.72|-5.33|0.718
91560535|NCT03122860|183010067|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.017|TWO_SIDED|95.0|-14.54|-1.45|||ANCOVA|||||-1.45|-14.54|0.017
91560536|NCT03122860|183010067|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.682|TWO_SIDED|95.0|-8.06|5.29|||ANCOVA|||||5.29|-8.06|0.682
91560537|NCT03122860|183010068|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.822|TWO_SIDED|95.0|-0.16|0.21|||ANCOVA|||||0.21|-0.16|0.822
91560538|NCT03122860|183010068|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.162|TWO_SIDED|95.0|-0.27|0.04|||ANCOVA|||||0.04|-0.27|0.162
91560539|NCT03122860|183010068|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.267|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||||0.09|-0.34|0.267
91560540|NCT03122860|183010068|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.685|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.685
91560541|NCT03122860|183010068|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.342|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||||0.24|-0.09|0.342
91560542|NCT03122860|183010069|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5|TWO_SIDED|95.0|-8.36|4.1|||ANCOVA|||||4.10|-8.36|0.500
91560543|NCT03122860|183010069|SUPERIORITY||Mean Difference (Final Values)|-5.54||||0.082|TWO_SIDED|95.0|-11.8|0.72|||ANCOVA|||||0.72|-11.80|0.082
91560544|NCT03122860|183010069|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.552|TWO_SIDED|95.0|-8.36|4.48|||ANCOVA|||||4.48|-8.36|0.552
91560545|NCT03122860|183010069|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.033|TWO_SIDED|95.0|-13.16|-0.56|||ANCOVA|||||-0.56|-13.16|0.033
91560546|NCT03122860|183010069|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.887|TWO_SIDED|95.0|-5.79|6.68|||ANCOVA|||||6.68|-5.79|0.887
91560547|NCT03122860|183010070|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.473|TWO_SIDED|95.0|-7.99|3.72|||ANCOVA|||||3.72|-7.99|0.473
91560548|NCT03122860|183010070|SUPERIORITY||Mean Difference (Final Values)|-6.31||||0.04|TWO_SIDED|95.0|-12.33|-0.29|||ANCOVA|||||-0.29|-12.33|0.040
91560549|NCT03122860|183010070|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.577|TWO_SIDED|95.0|-4.35|7.79|||ANCOVA|||||7.79|-4.35|0.577
91560550|NCT03122860|183010070|SUPERIORITY||Mean Difference (Final Values)|-8.95||||0.003|TWO_SIDED|95.0|-14.9|-3.01|||ANCOVA|||||-3.01|-14.90|0.003
91560551|NCT03122860|183010070|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.947|TWO_SIDED|95.0|-6.37|5.96|||ANCOVA|||||5.96|-6.37|0.947
91560552|NCT03122860|183010071|SUPERIORITY||Mean Difference (Final Values)|-3.05||||0.299|TWO_SIDED|95.0|-8.83|2.73|||ANCOVA|||||2.73|-8.83|0.299
91560553|NCT03122860|183010071|SUPERIORITY||Mean Difference (Final Values)|-7.18||||0.021|TWO_SIDED|95.0|-13.24|-1.12|||ANCOVA|||||-1.12|-13.24|0.021
91560554|NCT03122860|183010071|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.675|TWO_SIDED|95.0|-4.75|7.33|||ANCOVA|||||7.33|-4.75|0.675
91560555|NCT03122860|183010071|SUPERIORITY||Mean Difference (Final Values)|-8.63||||0.006|TWO_SIDED|95.0|-14.7|-2.55|||ANCOVA|||||-2.55|-14.70|0.006
91560556|NCT03122860|183010071|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.925|TWO_SIDED|95.0|-5.99|6.59|||ANCOVA|||||6.59|-5.99|0.925
91560557|NCT03122860|183010072|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.062|TWO_SIDED|95.0|-1.18|0.03|||ANCOVA|||||0.03|-1.18|0.062
91560558|NCT03122860|183010072|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.001|TWO_SIDED|95.0|-1.54|-0.37|||ANCOVA|||||-0.37|-1.54|0.001
91560559|NCT03122860|183010072|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5|||ANCOVA|||||0.50|-0.75|0.693
91560560|NCT03122860|183010072|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.012|TWO_SIDED|95.0|-1.39|-0.17|||ANCOVA|||||-0.17|-1.39|0.012
91560561|NCT03122860|183010072|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.697|TWO_SIDED|95.0|-0.49|0.74|||ANCOVA|||||0.74|-0.49|0.697
91560562|NCT03122860|183010073|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.254|TWO_SIDED|95.0|-9.04|2.4|||ANCOVA|||||2.40|-9.04|0.254
91560563|NCT03122860|183010073|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.031|TWO_SIDED|95.0|-13.1|-0.63|||ANCOVA|||||-0.63|-13.10|0.031
91560564|NCT03122860|183010073|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.616|TWO_SIDED|95.0|-7.2|4.28|||ANCOVA|||||4.28|-7.20|0.616
91560565|NCT03122860|183010073|SUPERIORITY||Mean Difference (Final Values)|-7.62||||0.01|TWO_SIDED|95.0|-13.41|-1.82|||ANCOVA|||||-1.82|-13.41|0.010
91560566|NCT03122860|183010073|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.961|TWO_SIDED|95.0|-5.74|5.46|||ANCOVA|||||5.46|-5.74|0.961
91560567|NCT01138657|183010074|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.70|0.36|<0.001
91560568|NCT01138657|183010074|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.76|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.76|0.40|< 0.001
91560569|NCT01138657|183010075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.29||||0.011|TWO_SIDED|95.0|-0.51|-0.07|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.07|-0.51|0.011
91560570|NCT01138657|183010075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.25||||0.019|TWO_SIDED|95.0|-0.46|-0.04|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.04|-0.46|0.019
91560571|NCT01138657|183010076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.43|-0.11|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.11|-0.43|<0.001
91560572|NCT01138657|183010076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.43|-0.12|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.12|-0.43|<0.001
91560573|NCT01138657|183010077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.07||||0.003|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.11|0.003
91560574|NCT01138657|183010077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.06||||0.008|TWO_SIDED|95.0|-0.1|-0.02|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.10|0.008
91560575|NCT01138657|183010078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.231|TWO_SIDED|95.0|0.39|1.26|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.26|0.39|0.231
91560576|NCT01138657|183010078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.191|TWO_SIDED|95.0|0.38|1.21|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.21|0.38|0.191
91768837|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
91768838|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
91560577|NCT01138657|183010079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-11.4||||0.02|TWO_SIDED|95.0|-20.9|-1.8|||ANOVA|ANOVA with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-1.8|-20.9|0.020
91560578|NCT01138657|183010079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-5.1||||0.428|TWO_SIDED|95.0|-17.7|7.5|||Chi-squared, Corrected|ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.5|-17.7|0.428
91560579|NCT01138657|183010080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.2||||0.01|TWO_SIDED|95.0|1.02|7.38|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.38|1.02|0.010
91768839|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-35.0||||0.108|TWO_SIDED|95.0|-70.8|0.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||0.8|-70.8|0.108
91768840|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||52.6|-27.6|0.686
91560580|NCT01138657|183010080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|3.67||||0.019|TWO_SIDED|95.0|0.62|6.71|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.71|0.62|0.019
91560581|NCT01138657|183010081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.86||||0.346|TWO_SIDED|95.0|-2.03|5.75|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.75|-2.03|0.346
91560582|NCT01138657|183010081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.31||||0.496|TWO_SIDED|95.0|-2.47|5.09|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.09|-2.47|0.496
91560583|NCT01138657|183010082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|5.12||||0.036|TWO_SIDED|95.0|0.34|9.9|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||9.90|0.34|0.036
91560584|NCT01138657|183010082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.14||||0.077|TWO_SIDED|95.0|-0.45|8.72|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||8.72|-0.45|0.077
91560585|NCT01138657|183010083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|10.02|||<|0.001|TWO_SIDED|95.0|4.86|15.19|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||15.19|4.86|<0.001
91768841|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
91560586|NCT01138657|183010083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|8.83|||<|0.001|TWO_SIDED|95.0|3.88|13.79|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%||13.79|3.88|<0.001
91560587|NCT00090519|183010098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.714|0.686|||ANOVA|||||0.686|-0.714|0.969
91560588|NCT00090519|183010099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.015|TWO_SIDED|95.0|0.21|1.97||P-value is for change from baseline.|ANCOVA|||||1.97|0.21|0.015
91560589|NCT00090519|183010100|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||P-value is for first occurrence of focal/grid photocoagulation yes versus no.|Chi-squared|||||||0.577
91560590|NCT00090519|183010101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.041|TWO_SIDED|95.0|0.02|0.87||P-value is for change from baseline.|ANCOVA|||||0.87|0.02|0.041
91560591|NCT00090519|183010102|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression.|Chi-squared|||||||0.475
91560592|NCT00090519|183010103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.211|TWO_SIDED|95.0|-0.87|3.92||P-value is for change from baseline.|ANCOVA|||||3.92|-0.87|0.211
91560593|NCT00090519|183010104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.22||||0.365|TWO_SIDED|95.0|-73.68|200.12||P-value is for change from baseline.|t-test, 2 sided|||||200.12|-73.68|0.365
91560594|NCT00090519|183010105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.009|TWO_SIDED|95.0|0.38|2.66||P-value is for change from baseline.|ANCOVA|||||2.66|0.38|0.009
91560595|NCT00090519|183010107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.081|TWO_SIDED|95.0|0.2|1.12||P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no.|Chi-squared|||||1.12|0.20|0.081
91560596|NCT02725372|183010131|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.87|TWO_SIDED|95.0|-22.47|26.45|||Mixed Models Analysis|||||26.45|-22.47|0.87
91560597|NCT02725372|183010132|SUPERIORITY|||||||0.55|||||||Log Rank|||||||0.55
91560598|NCT02725372|183010134|SUPERIORITY||Mean Difference (Final Values)|-89.1||||0.01|TWO_SIDED|95.0|-156.0|-22.1|||ANCOVA|||||-22.1|-156.0|0.01
91560599|NCT02725372|183010135|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.47|TWO_SIDED|95.0|-0.89|0.41|||ANCOVA|||||0.41|-0.89|0.47
91560600|NCT02725372|183010136|SUPERIORITY||Odds Ratio (OR)|1.05||||0.26|TWO_SIDED|95.0|0.48|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.48|0.26
91560601|NCT02548585|183010137|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.||||||< 0.0001
91560602|NCT02548585|183010138|SUPERIORITY|||||||0.0008|||||||ANCOVA|p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.||||||0.0008
91768842|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
91768843|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.2|5.8|0.099
91768844|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
91560603|NCT03659136|183010168|OTHER||Hazard Ratio (HR)|1.19||||0.6534|TWO_SIDED|95.0|0.55|2.59|||Log-rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior (CDK) 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||2.59|0.55|0.6534
91560604|NCT03659136|183010169|OTHER||Hazard Ratio (HR)|0.5||||0.1797|TWO_SIDED|95.0|0.18|1.4|||Log rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.40|0.18|0.1797
91560605|NCT03659136|183010170|OTHER||Odds Ratio (OR)|1.31||||0.4932|TWO_SIDED|95.0|0.6|2.86|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.86|0.60|0.4932
91560606|NCT03659136|183010172|OTHER||Odds Ratio (OR)|1.2||||0.7759|TWO_SIDED|95.0|0.34|4.43|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||4.43|0.34|0.7759
91560607|NCT03659136|183010173|OTHER||Cox Proportional Hazard|0.97||||0.9279|TWO_SIDED|95.0|0.54|1.76|||Log Rank|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK4/6 inhibitor treatment and menopause status.|Comparison versus Placebo+everolimus+exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.76|0.54|0.9279
91560608|NCT04620733|183010187|SUPERIORITY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|27.7|53.4||Two-sided p-value for pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (baseline ALP level: \< 350 U/L and ≥ 350 U/L; baseline Pruritus NRS: \< 4 and ≥ 4).|Cochran-Mantel-Haenszel|||||53.4|27.7|< 0.0001
91560609|NCT04620733|183010190|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|18.3|33.2|||Cochran-Mantel-Haenszel||Two-sided p-value for pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both stratification variables (baseline ALP level: \< 350 U/L and \>= 350 U/L; baseline pruritus NRS: \< 4 and \>= 4).|||33.2|18.3|< 0.0001
91768845|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-38.0|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||38.0|-38.0|1.000
91560610|NCT04620733|183010191|SUPERIORITY||Least Squares (LS) Mean Difference|-1.5||||0.0047|TWO_SIDED|95.0|-2.5|-0.5|||MMRM|Mixed-Effect Model Repeated Measure (MMRM)||||-0.5|-2.5|0.0047
91560611|NCT02221934|183010192|SUPERIORITY||Risk Difference (RD)|0.176||||0.002|TWO_SIDED|95.0|0.07|0.283|||Regression, Logistic||Difference in Responders between groups presented.|||0.283|0.070|0.002
91560612|NCT00805792|183010233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
91560613|NCT00805792|183010234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
91560614|NCT00805792|183010235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
91560615|NCT01416285|183010237|SUPERIORITY|||||||0.004|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||All-cause death||||0.004
91560616|NCT01416285|183010237|SUPERIORITY|||||||0.003|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||Heart failure-related re-hospitalizations||||0.003
91768846|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|15.6||||0.465|TWO_SIDED|95.0|-19.5|50.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||50.7|-19.5|0.465
91768847|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|3.9||||0.745|TWO_SIDED|95.0|-19.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||27.0|-19.3|0.745
91560617|NCT01416285|183010237|SUPERIORITY||||||<|0.001|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||a composite outcome of both death and heart failure-related re-hospitalizations||||<0.001
91560618|NCT01690000|183010238|SUPERIORITY_OR_OTHER||||||<|0.05||||||The p-value was calculated|t-test, 2 sided|||The p-value was calculated||||<0.05
91560619|NCT04351243|183010240|SUPERIORITY||Risk Difference (RD)|0.05||||0.1885|TWO_SIDED|95.0|-0.06|0.17||one-sided p value|Mantel Haenszel|||||0.17|-0.06|0.1885
91560620|NCT01248715|183010247|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||.460
91560621|NCT01248715|183010248|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
91560622|NCT01248715|183010249|SUPERIORITY|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||.732
91560623|NCT01248715|183010250|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
91560624|NCT01248715|183010251|SUPERIORITY|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
91560625|NCT01248715|183010252|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||.796
91560626|NCT01248715|183010253|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
91560627|NCT00813709|183010254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.555||||0.002|TWO_SIDED|95.0|0.378|0.816|||Log Rank|||||0.816|0.378|0.002
91560628|NCT00813709|183010254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.006|TWO_SIDED|95.0|0.391|0.839|||Log Rank|||||0.839|0.391|0.006
91560629|NCT00813709|183010254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993||||0.941|TWO_SIDED|95.0|0.654|1.51|||Log Rank|||||1.510|0.654|0.941
91560630|NCT00813709|183010255|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Log Rank|||||||0.205
91560631|NCT00813709|183010255|SUPERIORITY_OR_OTHER|||||||0.263||95.0|||||Log Rank|||||||0.263
91768848|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-8.3||||0.512|TWO_SIDED|95.0|-32.6|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||16.1|-32.6|0.512
91768849|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|22.5||||0.281|TWO_SIDED|95.0|-12.2|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||57.2|-12.2|0.281
91768850|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-8.1||||0.486|TWO_SIDED|95.0|-30.8|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||14.6|-30.8|0.486
91768851|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-15.8||||0.212|TWO_SIDED|95.0|-39.5|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||8.0|-39.5|0.212
91768852|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
91560632|NCT00813709|183010255|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||Log Rank|||||||0.629
91560633|NCT01345253|183010298|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99||||0.0001|TWO_SIDED|95.0|1.4|2.82|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).|||2.82|1.40|0.0001
91560634|NCT01345253|183010299|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.0001|TWO_SIDED|95.0|1.41|2.83|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.83|1.41|0.0001
91768853|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
91768854|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
91768855|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||39.9|-23.7|0.678
91560635|NCT01345253|183010300|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.76||||0.0116|TWO_SIDED|95.0|1.13|2.74|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.74|1.13|0.0116
91560636|NCT01345253|183010301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0288|||||||Rank ANCOVA|||||||0.0288
91560637|NCT01345253|183010302|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0004|TWO_SIDED|95.0|0.34|0.73|||Regression, Cox|||||0.73|0.34|0.0004
91560638|NCT01180400|183010349|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.944|TWO_SIDED|95.0|-1.86|1.73||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-1.86|0.944
91560639|NCT01180400|183010350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.974|TWO_SIDED|95.0|0.61|1.66|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.66|0.61|0.974
91560640|NCT01180400|183010351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.41||0.184|TWO_SIDED|95.0|0.84|2.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.53|0.84|0.184
91768856|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|1.7||||0.873|TWO_SIDED|95.0|-18.6|21.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||21.9|-18.6|0.873
91768857|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-0.1||||0.99|TWO_SIDED|95.0|-22.3|22.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.0|-22.3|0.990
91768858|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
91560641|NCT01180400|183010352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.71||0.461|TWO_SIDED|95.0|0.55|3.78|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.78|0.55|0.461
91560642|NCT01180400|183010353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.31||0.689|TWO_SIDED|95.0|0.43|1.75|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.75|0.43|0.689
91560643|NCT01180400|183010354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.44||0.831|TWO_SIDED|95.0|0.35|2.32|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.32|0.35|0.831
91560644|NCT01180400|183010355|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.525|TWO_SIDED|95.0|-0.96|1.89|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.89|-0.96|0.525
91560645|NCT01180400|183010356|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.964||95.0|-0.28|0.26|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.26|-0.28|0.964
91560646|NCT01180400|183010357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.25||0.783|TWO_SIDED|95.0|0.54|1.58|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.58|0.54|0.783
91768859|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
91768860|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
91768861|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|23.2||||0.169|TWO_SIDED|95.0|-1.6|48.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.1|-1.6|0.169
91768862|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|30.6||||0.005|TWO_SIDED|95.0|11.5|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.7|11.5|0.005
91560647|NCT01180400|183010358|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.832|TWO_SIDED|95.0|-0.89|1.11||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-0.89|0.832
91560648|NCT01180400|183010359|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.468|TWO_SIDED|95.0|-0.84|1.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.82|-0.84|0.468
91560649|NCT01180400|183010360|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.77||0.187|TWO_SIDED|95.0|-0.49|2.52|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.52|-0.49|0.187
91560650|NCT01180400|183010361|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.86||0.145|TWO_SIDED|95.0|-0.44|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|-0.44|0.145
91560651|NCT01180400|183010362|SUPERIORITY_OR_OTHER||LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.766||0.956|TWO_SIDED|95.0|-1.549|1.466||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.466|-1.549|0.956
91560652|NCT01180400|183010363|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-0.98|0.21||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.21|-0.98|0.201
91560653|NCT01180400|183010364|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.756|TWO_SIDED|95.0|-0.62|0.45|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.45|-0.62|0.756
91560654|NCT01180400|183010365|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.62|TWO_SIDED|95.0|-0.4|0.68|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.68|-0.40|0.620
91560655|NCT01180400|183010366|SUPERIORITY_OR_OTHER||LS mean|0.15|STANDARD_ERROR_OF_MEAN|1.592||0.924|TWO_SIDED|95.0|-2.981|3.286|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.286|-2.981|0.924
91560656|NCT01180400|183010367|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.345|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.10|-0.30|0.345
91560657|NCT01180400|183010368|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.942|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.19|-0.20|0.942
91560658|NCT01180400|183010369|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0198||0.576|TWO_SIDED|95.0|-0.05|0.0279||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0279|-0.0500|0.576
91560659|NCT01180400|183010369|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|2.11||0.842|TWO_SIDED|95.0|-4.58|3.73||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.73|-4.58|0.842
91560660|NCT00795639|183010370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0||||0.0104|TWO_SIDED|95.0|3.0|26.0||Significance test performed using non-parametric analysis of covariance controlling for Baseline 6MWD and PAH etiology and PAH not secondary to a connective tissue disease (other).|ANCOVA||Missing value at Week 12 assigned as zero if the subject had a predefined clinical worsening event, otherwise, missing value at Week 12 imputed with the last non-missing 6MWD based on LOCF.|||26|3|0.0104
91560661|NCT00795639|183010371|SUPERIORITY_OR_OTHER|||||||0.2908|TWO_SIDED|||||Significance tests of WHO Functional Class performed using the Cochran-Mantel-Haenszel (CMH) test, stratified by Baseline 6MWD (less than 310 meters and greater than or equal to 310 meters) and PAH Etiology (Connective Tissue Disease and others).|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores, and the p-value corresponding to ANCOVA (row mean scores) statistics were used.||Week 12||||0.2908
91560662|NCT00248794|183010381|SUPERIORITY_OR_OTHER||||||<|0.97|||||||ANOVA|||||||<.97
91560663|NCT00248794|183010382|SUPERIORITY_OR_OTHER|||||||0.77|||||||ANOVA|||||||.77
91560664|NCT03449979|183010386|SUPERIORITY|||||||0.0852|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 3.119||Interaction in the effect of tACS on left frontal alpha oscillation in the depressed group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.0852
91768863|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|0.7||||0.963|TWO_SIDED|95.0|-26.8|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-26.8|0.963
91560665|NCT03449979|183010386|SUPERIORITY|||||||0.6676|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 0.187||Interaction in the effect of tACS on left frontal alpha oscillation in the healthy group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.6676
91560666|NCT03449979|183010386|SUPERIORITY|||||||0.929||||||degrees of freedom = (1,41); F-statistic = 0.008|ANOVA|||Main effect of alpha-tACS on session (before and after) on left frontal alpha oscillations across both groups (healthy and patient).||||0.929
91560667|NCT03449979|183010386|SUPERIORITY|||||||0.195|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = -0.08789||Difference in alpha oscillations after versus before in the depressed cohort (one-tailed Student's t-test) with the hypothesis to decrease pathologically elevate left frontal alpha oscillations||||0.1950
91560668|NCT03449979|183010386|SUPERIORITY|||||||0.8603|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = 1.1117||Difference in alpha oscillations after versus before in the healthy cohort (one-tailed Student's t-test) run as a control analysis||||0.8603
91560669|NCT01694199|183010387|SUPERIORITY_OR_OTHER|||||||0.3529|||||||ANCOVA|||||||0.3529
91560670|NCT01694199|183010388|SUPERIORITY_OR_OTHER|||||||0.2766|||||||ANCOVA|||||||0.2766
91560671|NCT01694199|183010389|SUPERIORITY_OR_OTHER|||||||0.1467|||||||ANOVA|||P=0.1467||||0.1467
91768864|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|6.7||||0.729|TWO_SIDED|95.0|-19.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||33.2|-19.8|0.729
91768865|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-2.9||||0.804|TWO_SIDED|95.0|-25.8|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-25.8|0.804
91768866|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-14.0||||0.306|TWO_SIDED|95.0|-41.1|13.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||13.1|-41.1|0.306
91768867|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
91560672|NCT01694199|183010390|SUPERIORITY_OR_OTHER|||||||0.5009|||||||ANOVA|||P = 0.5009||||0.5009
91560673|NCT01694199|183010391|SUPERIORITY_OR_OTHER|||||||0.9038|||||||ANOVA|||||||0.9038
91560674|NCT01124916|183010394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8728.0|STANDARD_ERROR_OF_MEAN|853.129|<|0.001|TWO_SIDED|95.0|7028.846|10427.154|||t-test, 2 sided|||The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.||10427.154|7028.846|<.001
91560675|NCT01124916|183010395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2|STANDARD_ERROR_OF_MEAN|7.846||0.43|TWO_SIDED|95.0|-21.769|9.369|||t-test, 2 sided|||The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.||9.369|-21.769|.43
91560676|NCT02206607|183010396|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.27|||||TWO_SIDED|90.0|28.09|34.8||||||||34.80|28.09|
91560677|NCT02206607|183010396|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|25.56|||||TWO_SIDED|90.0|23.11|28.27||||||||28.27|23.11|
91560678|NCT02206607|183010396|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|32.04|||||TWO_SIDED|90.0|28.93|35.49||||||||35.49|28.93|
91560679|NCT02206607|183010397|SUPERIORITY_OR_OTHER||Least Square Mean|15.72|STANDARD_ERROR_OF_MEAN|3.357||1|TWO_SIDED|80.0|11.39|20.06||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.06|11.39|1.0000
91560680|NCT02206607|183010397|SUPERIORITY_OR_OTHER||Least Square Mean|16.31|STANDARD_ERROR_OF_MEAN|3.399||1|TWO_SIDED|80.0|11.93|20.7||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.70|11.93|1.000
91560681|NCT02206607|183010397|SUPERIORITY_OR_OTHER||Least Square Mean|20.38|STANDARD_ERROR_OF_MEAN|3.291||1|TWO_SIDED|80.0|16.13|24.62||1-sided p-value|Mixed Models Analysis|||||24.62|16.13|1.0000
91560682|NCT02206607|183010398|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|25.21|||||TWO_SIDED|90.0|23.28|27.31||||||||27.31|23.28|
91560683|NCT02206607|183010398|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|26.38|||||TWO_SIDED|90.0|24.36|28.57||||||||28.57|24.36|
91560684|NCT02206607|183010398|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|36.94|||||TWO_SIDED|90.0|34.09|40.02||||||||40.02|34.09|
91560685|NCT02206607|183010404|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.06|||||TWO_SIDED|90.0|28.28|34.1||||||||34.10|28.28|
91560686|NCT02206607|183010404|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|24.96|||||TWO_SIDED|90.0|22.73|27.4||||||||27.40|22.73|
91560687|NCT02206607|183010404|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|31.69|||||TWO_SIDED|90.0|28.86|34.81||||||||34.81|28.86|
91560688|NCT03014726|183010434|OTHER|Recurrence \< 0.5 as defined by an IPSS score of less than or equal to 11. The performance goal is met if the upper limit of the one-sided 95% confidence interval for recurrence is less than 50%.|||||<|0.001|||||||1-sample binomial z-test|||||||<0.001
91560689|NCT02159352|183010442|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.384|||||TWO_SIDED|90.0|0.348|0.423||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.423|0.348|
91560690|NCT02159352|183010442|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.337|||||TWO_SIDED|90.0|0.306|0.371||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.371|0.306|
91560691|NCT02159352|183010443|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.703|||||TWO_SIDED|90.0|0.658|0.75||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.750|0.658|
91560692|NCT02159352|183010443|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.577|||||TWO_SIDED|90.0|0.535|0.622||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.622|0.535|
91560693|NCT02159352|183010446|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.768|||||TWO_SIDED|90.0|0.697|0.846||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.846|0.697|
91560694|NCT02159352|183010446|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.673|||||TWO_SIDED|90.0|0.611|0.742||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.742|0.611|
91560695|NCT02159352|183010447|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.406|||||TWO_SIDED|90.0|1.317|1.501||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.501|1.317|
91560696|NCT02159352|183010447|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.154|||||TWO_SIDED|90.0|1.07|1.244||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.244|1.070|
91560697|NCT00337610|183010470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02|STANDARD_DEVIATION|1.19|<|0.001||95.0|-1.36|-0.67|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic agent (AHA) \[medication\] (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.67|-1.36|<0.001
91560698|NCT00337610|183010471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.5|STANDARD_DEVIATION|42.2|<|0.001||95.0|-37.7|-13.3|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-13.3|-37.7|<0.001
91560699|NCT00337610|183010472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_DEVIATION|63.8|<|0.001||95.0|-74.7|-33.6|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-33.6|-74.7|<0.001
91560700|NCT00337610|183010473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.01|STANDARD_DEVIATION|1.34|<|0.001||95.0|-1.4|-0.62|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.62|-1.40|<0.001
91560701|NCT03979040|183010474|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5||||P value = .025 (one-sided) and sign test below|Sign test|||||||.025
91560702|NCT03979040|183010475|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
91560703|NCT03979040|183010476|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
91560704|NCT04012970|183010480|SUPERIORITY||||||<|0.05|||||||ANOVA|2-way, repeated measures||||||<0.05
91768868|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
91560705|NCT04012970|183010480|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
91768869|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||4.1|-51.2|0.101
91768870|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|7.1||||0.655|TWO_SIDED|95.0|-24.0|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.3|-24.0|0.655
91560706|NCT04012970|183010481|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
91560707|NCT04012970|183010481|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
91768871|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|15.5||||0.221|TWO_SIDED|95.0|-9.0|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||40.0|-9.0|0.221
91560708|NCT04012970|183010482|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
91768872|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
91560709|NCT04012970|183010482|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
91560710|NCT04012970|183010483|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
91560711|NCT04012970|183010483|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
91560712|NCT04012970|183010484|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
91560713|NCT04012970|183010485|SUPERIORITY||||||<|0.001|||||||ANOVA|2-way, repeated measures||||||<0.001
91560714|NCT02978183|183010486|SUPERIORITY|||||||0.0882||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0882
91560715|NCT02978183|183010486|SUPERIORITY|||||||0.8032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 5 Minutes Post-CAC||||0.8032
91560716|NCT02978183|183010486|SUPERIORITY|||||||0.9003||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 7 Minutes Post-CAC||||0.9003
91560717|NCT02978183|183010486|SUPERIORITY|||||||0.9523||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9523
91560718|NCT02978183|183010486|SUPERIORITY|||||||0.9071||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9071
91560719|NCT02978183|183010486|SUPERIORITY|||||||0.7509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7509
91560720|NCT02978183|183010486|SUPERIORITY|||||||0.2824||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.2824
91560721|NCT02978183|183010486|SUPERIORITY|||||||0.4017||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.4017
91560722|NCT02978183|183010486|SUPERIORITY|||||||0.4497||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.4497
91560723|NCT02978183|183010486|SUPERIORITY|||||||0.165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.1650
91560724|NCT02978183|183010486|SUPERIORITY|||||||0.3494||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 5 Minutes Post-CAC||||0.3494
91560725|NCT02978183|183010486|SUPERIORITY|||||||0.4781||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 7 Minutes Post-CAC||||0.4781
91560726|NCT02978183|183010486|SUPERIORITY|||||||0.9847||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.9847
91560727|NCT02978183|183010486|SUPERIORITY|||||||0.9731||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.9731
91560728|NCT02978183|183010486|SUPERIORITY|||||||0.6984||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6984
91560729|NCT02978183|183010486|SUPERIORITY|||||||0.6265||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.6265
91560730|NCT02978183|183010486|SUPERIORITY|||||||0.7848||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7848
91560731|NCT02978183|183010486|SUPERIORITY|||||||0.5789||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.5789
91560732|NCT02978183|183010487|SUPERIORITY|||||||0.8165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8165
91560733|NCT02978183|183010487|SUPERIORITY|||||||0.659||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.6590
91560734|NCT02978183|183010487|SUPERIORITY|||||||0.7455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7455
91560735|NCT02978183|183010487|SUPERIORITY|||||||0.9212||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9212
91560736|NCT02978183|183010487|SUPERIORITY|||||||0.9509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.9509
91560737|NCT02978183|183010487|SUPERIORITY|||||||0.7897||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7897
91560738|NCT02978183|183010487|SUPERIORITY|||||||0.3183||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.3183
91560739|NCT02978183|183010487|SUPERIORITY|||||||0.7604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.7604
91560740|NCT02978183|183010487|SUPERIORITY|||||||0.7343||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7343
91560741|NCT02978183|183010487|SUPERIORITY|||||||0.153||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.1530
91560742|NCT02978183|183010487|SUPERIORITY|||||||0.3307||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.3307
91560743|NCT02978183|183010487|SUPERIORITY|||||||0.3399||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3399
91560744|NCT02978183|183010487|SUPERIORITY|||||||0.5137||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5137
91560745|NCT02978183|183010487|SUPERIORITY|||||||0.9962||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9962
91560746|NCT02978183|183010488|SUPERIORITY|||||||0.3259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3259
91560747|NCT02978183|183010488|SUPERIORITY|||||||0.9785||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9785
91560748|NCT02978183|183010488|SUPERIORITY|||||||0.5112||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5112
91560749|NCT02978183|183010488|SUPERIORITY|||||||0.7771||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7771
91560750|NCT02978183|183010488|SUPERIORITY|||||||0.6232||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.6232
91560751|NCT02978183|183010488|SUPERIORITY|||||||0.8895||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.8895
91560752|NCT02978183|183010488|SUPERIORITY|||||||0.8974||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8974
91560753|NCT02978183|183010488|SUPERIORITY|||||||0.9604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.9604
91560754|NCT02978183|183010488|SUPERIORITY|||||||0.5301||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 minutes Post-CAC||||0.5301
91560755|NCT02978183|183010488|SUPERIORITY|||||||0.0386||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0386
91560756|NCT02978183|183010488|SUPERIORITY|||||||0.1034||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.1034
91560757|NCT02978183|183010488|SUPERIORITY|||||||0.0985||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0985
91560758|NCT02978183|183010488|SUPERIORITY|||||||0.2342||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2342
91560759|NCT02978183|183010488|SUPERIORITY|||||||0.3016||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3016
91560760|NCT02978183|183010489|SUPERIORITY|||||||0.4927||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4927
91560761|NCT02978183|183010489|SUPERIORITY|||||||0.8686||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8686
91560762|NCT02978183|183010489|SUPERIORITY|||||||0.5772||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5772
91560763|NCT02978183|183010489|SUPERIORITY|||||||0.97||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9700
91560764|NCT02978183|183010489|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.7516
91560765|NCT02978183|183010489|SUPERIORITY|||||||0.9532||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9532
91560766|NCT02978183|183010489|SUPERIORITY|||||||0.7522||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.7522
91560767|NCT02978183|183010489|SUPERIORITY|||||||0.6804||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6804
91560768|NCT02978183|183010489|SUPERIORITY|||||||0.6267||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.6267
91560769|NCT02978183|183010489|SUPERIORITY|||||||0.0976||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0976
91560770|NCT02978183|183010489|SUPERIORITY|||||||0.4687|||||||ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4687
91560771|NCT02978183|183010489|SUPERIORITY|||||||0.0421||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0421
91560772|NCT02978183|183010489|SUPERIORITY|||||||0.6085||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.6085
91560773|NCT02978183|183010489|SUPERIORITY|||||||0.9634||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9634
91560774|NCT02978183|183010490|SUPERIORITY|||||||0.3322||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3322
91560775|NCT02978183|183010490|SUPERIORITY|||||||0.8026||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Pre-CAC||||0.8026
91560776|NCT02978183|183010490|SUPERIORITY|||||||0.9981||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Pre-CAC||||0.9981
91560777|NCT02978183|183010490|SUPERIORITY|||||||0.5645||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5645
91560778|NCT02978183|183010490|SUPERIORITY|||||||0.5455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5455
91560779|NCT02978183|183010490|SUPERIORITY|||||||0.698||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6980
91560780|NCT02978183|183010490|SUPERIORITY|||||||0.6115||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6115
91560781|NCT02978183|183010490|SUPERIORITY|||||||0.4528||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.4528
91560782|NCT02978183|183010490|SUPERIORITY|||||||0.7551||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7551
91560783|NCT02978183|183010490|SUPERIORITY|||||||0.5318||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.5318
91560784|NCT02978183|183010490|SUPERIORITY|||||||0.9748||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.9748
91560785|NCT02978183|183010490|SUPERIORITY|||||||0.7706||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7706
91560786|NCT02978183|183010490|SUPERIORITY|||||||0.3414||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.3414
91560787|NCT02978183|183010490|SUPERIORITY|||||||0.4361||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.4361
91560788|NCT02978183|183010491|SUPERIORITY|||||||0.0603||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0603
91560789|NCT02978183|183010491|SUPERIORITY|||||||0.4857||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.4857
91560790|NCT02978183|183010491|SUPERIORITY|||||||0.9815||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9815
91560791|NCT02978183|183010491|SUPERIORITY|||||||0.6213||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.6213
91560792|NCT02978183|183010491|SUPERIORITY|||||||0.1831||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.1831
91560793|NCT02978183|183010491|SUPERIORITY|||||||0.6489||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6489
91560794|NCT02978183|183010491|SUPERIORITY|||||||0.2622||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2622
91560795|NCT02978183|183010491|SUPERIORITY|||||||0.2397||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.2397
91560796|NCT02978183|183010491|SUPERIORITY|||||||0.3202||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.3202
91560797|NCT02978183|183010491|SUPERIORITY|||||||0.2663||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.2663
91560798|NCT02978183|183010491|SUPERIORITY|||||||0.5672||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5672
91560799|NCT02978183|183010491|SUPERIORITY|||||||0.5055||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5055
91560800|NCT02978183|183010491|SUPERIORITY|||||||0.8143||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8143
91560801|NCT02978183|183010491|SUPERIORITY|||||||0.6901||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6901
91560802|NCT02978183|183010492|SUPERIORITY|||||||0.4032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4032
91560803|NCT02978183|183010492|SUPERIORITY|||||||0.2946||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.2946
91560804|NCT02978183|183010492|SUPERIORITY|||||||0.2863||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2863
91560805|NCT02978183|183010492|SUPERIORITY|||||||0.0891||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.0891
91560806|NCT02978183|183010492|SUPERIORITY|||||||0.5347||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5347
91560807|NCT02978183|183010492|SUPERIORITY|||||||0.3733||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.3733
91560808|NCT02978183|183010492|SUPERIORITY|||||||0.2506||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2506
91560809|NCT02978183|183010492|SUPERIORITY|||||||0.8667||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8667
91560810|NCT02978183|183010492|SUPERIORITY|||||||0.764||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7640
91560811|NCT02978183|183010492|SUPERIORITY|||||||0.8008||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8008
91560812|NCT02978183|183010492|SUPERIORITY|||||||0.4729||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4729
91560813|NCT02978183|183010492|SUPERIORITY|||||||0.4742||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.4742
91560814|NCT02978183|183010492|SUPERIORITY|||||||0.2922||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2922
91560815|NCT02978183|183010492|SUPERIORITY|||||||0.3657||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3657
91560816|NCT02978183|183010493|SUPERIORITY|||||||0.66||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.6600
91560817|NCT02978183|183010493|SUPERIORITY|||||||0.6877||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.6877
91560818|NCT02978183|183010493|SUPERIORITY|||||||0.334||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.3340
91560819|NCT02978183|183010493|SUPERIORITY|||||||0.7874||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7874
91560820|NCT02978183|183010493|SUPERIORITY|||||||0.3812||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.3812
91560821|NCT02978183|183010493|SUPERIORITY|||||||0.6987|||||||ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6987
91560822|NCT02978183|183010493|SUPERIORITY|||||||0.6832||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6832
91560823|NCT02978183|183010493|SUPERIORITY|||||||0.8521||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8521
91560824|NCT02978183|183010493|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7516
91560825|NCT02978183|183010493|SUPERIORITY|||||||0.6252||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6252
91560826|NCT02978183|183010493|SUPERIORITY|||||||0.8321||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.8321
91560827|NCT02978183|183010493|SUPERIORITY|||||||0.8173||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.8173
91560828|NCT02978183|183010493|SUPERIORITY|||||||0.5445||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5445
91560829|NCT02978183|183010493|SUPERIORITY|||||||0.681||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6810
91560830|NCT02978183|183010494|SUPERIORITY|||||||0.0111||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0111
91560831|NCT02978183|183010494|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.3391
91560832|NCT02978183|183010494|SUPERIORITY|||||||0.239||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2390
91560833|NCT02978183|183010494|SUPERIORITY|||||||0.3068||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.3068
91560834|NCT02978183|183010494|SUPERIORITY|||||||0.4914||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.4914
91560835|NCT02978183|183010494|SUPERIORITY|||||||0.5185||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.5185
91560836|NCT02978183|183010494|SUPERIORITY|||||||0.5262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.5262
91560837|NCT02978183|183010494|SUPERIORITY|||||||0.6098||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6098
91560838|NCT02978183|183010494|SUPERIORITY|||||||0.8849||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.8849
91560839|NCT02978183|183010494|SUPERIORITY|||||||0.6941||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6941
91560840|NCT02978183|183010494|SUPERIORITY|||||||0.5728||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5728
91560841|NCT02978183|183010494|SUPERIORITY|||||||0.5931||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5931
91560842|NCT02978183|183010494|SUPERIORITY|||||||0.7513||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7513
91560843|NCT02978183|183010494|SUPERIORITY|||||||0.7297||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.7297
91560844|NCT02978183|183010495|SUPERIORITY|||||||0.1259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.1259
91560845|NCT02978183|183010495|SUPERIORITY|||||||0.9234||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9234
91560846|NCT02978183|183010495|SUPERIORITY|||||||0.8816||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.8816
91560847|NCT02978183|183010495|SUPERIORITY|||||||0.5703||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5703
91560848|NCT02978183|183010495|SUPERIORITY|||||||0.5428||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5428
91560849|NCT02978183|183010495|SUPERIORITY|||||||0.7454||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7454
91560850|NCT02978183|183010495|SUPERIORITY|||||||0.8195||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8195
91560851|NCT02978183|183010495|SUPERIORITY|||||||0.0909||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.0909
91560852|NCT02978183|183010495|SUPERIORITY|||||||0.4881||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.4881
91560853|NCT02978183|183010495|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.3391
91560854|NCT02978183|183010495|SUPERIORITY|||||||0.6065||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6065
91560855|NCT02978183|183010495|SUPERIORITY|||||||0.3393||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3393
91560856|NCT02978183|183010495|SUPERIORITY|||||||0.8364||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8364
91560857|NCT02978183|183010495|SUPERIORITY|||||||0.8858||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.8858
91560858|NCT02978183|183010496|SUPERIORITY|||||||0.8818||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8818
91560859|NCT02978183|183010496|SUPERIORITY|||||||0.8679||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8679
91560860|NCT02978183|183010496|SUPERIORITY|||||||0.7856||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7856
91560861|NCT02978183|183010496|SUPERIORITY|||||||0.7507||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7507
91560862|NCT02978183|183010496|SUPERIORITY|||||||0.8189||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.8189
91560863|NCT02978183|183010496|SUPERIORITY|||||||0.9206||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9206
91560864|NCT02978183|183010496|SUPERIORITY|||||||0.9591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.9591
91560865|NCT02978183|183010496|SUPERIORITY|||||||0.5302||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.5302
91560866|NCT02978183|183010496|SUPERIORITY|||||||0.7591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7591
91560867|NCT02978183|183010496|SUPERIORITY|||||||0.8978||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8978
91560868|NCT02978183|183010496|SUPERIORITY|||||||0.7179||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.7179
91560869|NCT02978183|183010496|SUPERIORITY|||||||0.7262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7262
91560870|NCT02978183|183010496|SUPERIORITY|||||||0.8275||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8275
91560871|NCT02978183|183010496|SUPERIORITY|||||||0.618||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6180
91560872|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity were not employed|Fisher Exact|||Day 7: 10 minutes post-CAC||||>0.9999
91560873|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 15 minutes post-CAC||||>0.9999
91560874|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 20 minutes post-CAC||||>0.9999
91560875|NCT02978183|183010497|SUPERIORITY|||||||0.7312||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 25 minutes post-CAC||||0.7312
91560876|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 30 minutes post-CAC||||>0.9999
91560877|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 10 minutes post-CAC||||>0.9999
91560878|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 15 minutes post-CAC||||>0.9999
91560879|NCT02978183|183010497|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 20 minutes post-CAC||||>0.9999
91560880|NCT02978183|183010497|SUPERIORITY|||||||0.4297||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 25 minutes post-CAC||||0.4297
91560881|NCT02978183|183010497|SUPERIORITY|||||||0.4791||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 30 minutes post-CAC||||0.4791
91560882|NCT01326455|183010501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED|95.0|||||Chi-squared|||Lancaster et. al. (2004) quoted the number 30 as a general sample size for a pilot study. Each arm of this study had 25 people (due to time constraints), giving a total of 75 people. The data were analyzed using t-tests for equality of means, a two-way analysis of variance (ANOVA), and chi-square. Significance was set at p \< 0.05.||||0.25
91560883|NCT01326455|183010502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Chi-squared|||||||0.47
91560884|NCT01326455|183010503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
91560885|NCT01326455|183010503|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
91560886|NCT01326455|183010503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||ANOVA|||||||0.144
91560887|NCT01326455|183010504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372|||||||ANOVA|||||||0.372
91560888|NCT01326455|183010505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468|||||||Chi-squared|||||||0.468
91560889|NCT03055988|183010513|SUPERIORITY||Adjusted mean difference|-0.537|STANDARD_ERROR_OF_MEAN|1.12||0.6331|TWO_SIDED|95.0|-2.779|1.705|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|Mixed model repeated measures (MMRM) model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation. H0: Mean change from baseline in LVEDVI for (Tiotropium + Olodaterol) = Mean change from baseline in LVEDVI for (Fluticasone propionate + Salmeterol)||1.705|-2.779|0.6331
91768873|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.9|-4.8|0.124
91768874|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.9|-9.5|0.234
91768875|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-4.8||||0.741|TWO_SIDED|95.0|-32.9|23.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||23.4|-32.9|0.741
91768876|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-25.0||||0.544|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-6.0|-44.0|0.544
91768877|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-15.5||||0.238|TWO_SIDED|95.0|-38.2|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||7.3|-38.2|0.238
91560890|NCT03055988|183010514|SUPERIORITY||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.036||0.9817|TWO_SIDED|95.0|-0.072|0.074|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.074|-0.072|0.9817
91560891|NCT03055988|183010515|SUPERIORITY||Adjusted mean difference|1.28|STANDARD_ERROR_OF_MEAN|1.995||0.5238|TWO_SIDED|95.0|-2.719|5.279|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.279|-2.719|0.5238
91560892|NCT03055988|183010516|SUPERIORITY||Adjusted mean difference|2.069|STANDARD_ERROR_OF_MEAN|1.853||0.2687|TWO_SIDED|95.0|-1.64|5.779|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.779|-1.640|0.2687
91560893|NCT03055988|183010517|SUPERIORITY||Adjusted mean difference|0.409|STANDARD_ERROR_OF_MEAN|1.335||0.7604|TWO_SIDED|95.0|-2.264|3.082|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||3.082|-2.264|0.7604
91560894|NCT03055988|183010518|SUPERIORITY||Adjusted mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.509||0.833|TWO_SIDED|95.0|-3.341|2.702|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||2.702|-3.341|0.8330
91560895|NCT03055988|183010519|SUPERIORITY||Adjusted mean difference|-7.957|STANDARD_ERROR_OF_MEAN|2.452||0.0019|TWO_SIDED|95.0|-12.865|-3.05|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||-3.050|-12.865|0.0019
91560896|NCT03055988|183010520|SUPERIORITY||Adjusted mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.121|0.24|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.240|0.121|<0.0001
91560897|NCT03055988|183010521|SUPERIORITY||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|0.171|0.4|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.400|0.171|<0.0001
91560898|NCT02326220|183010568|SUPERIORITY||H-L estimate of median difference|0.75|||<|0.0001|TWO_SIDED|95.0|0.667|0.833||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|"Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI.~p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS."||0.833|0.667|< 0.0001
91560899|NCT02326220|183010569|SUPERIORITY||Least Square (LS) Mean Difference|-55.3|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|95.0|-63.0|-47.5||Threshold for significance at 0.05 level.|MMRM|MMRM: Mixed-effect model with repeated measures|Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-47.5|-63.0|< 0.0001
91560900|NCT02326220|183010570|SUPERIORITY||H-L estimate of median difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.5|1.0||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.000|0.500|<.0001
91560901|NCT02326220|183010571|SUPERIORITY||LS Mean Difference|-44.0|||<|0.0001|TWO_SIDED|95.0|-51.3|-36.6||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.6|-51.3|< 0.0001
91560902|NCT02326220|183010572|SUPERIORITY||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|95.0|-57.3|-42.7||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.7|-57.3|< 0.0001
91560903|NCT02326220|183010573|SUPERIORITY||LS Mean Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-45.6|-33.2||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.2|-45.6|< 0.0001
91560904|NCT02326220|183010574|SUPERIORITY||LS Mean Difference|4.2||||0.3012|TWO_SIDED|95.0|-3.9|12.3||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.3|-3.9|0.3012
91560905|NCT02699099|183010591|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
91560906|NCT02699099|183010596|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rate of the anti-measles antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|2.05|||||TWO_SIDED|95.0|-1.29|5.89|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||5.89|-1.29|
91560907|NCT02699099|183010599|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rates of the anti-rubella antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.5|||||TWO_SIDED|95.0|-1.29|2.78|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||"Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049."||2.78|-1.29|
91560908|NCT02699099|183010602|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seropositivity rates of the anti-yellow fever antibody , being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.55|||||TWO_SIDED|95.0|-2.3|3.65|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||3.65|-2.30|
91560909|NCT02699099|183010628|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
91560910|NCT01094106|183010630|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.||||0.10
91560911|NCT01094106|183010631|SUPERIORITY|||||||0.08||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 0-6 h||||0.08
91560912|NCT01094106|183010631|SUPERIORITY|||||||0.86||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 6-12 h||||0.86
91560913|NCT01094106|183010631|SUPERIORITY|||||||0.66||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 12-24 h||||0.66
91560914|NCT01094106|183010631|SUPERIORITY|||||||0.79||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 24-36 h||||0.79
91560915|NCT01094106|183010631|SUPERIORITY|||||||0.2||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 36-48 h||||0.20
91560916|NCT01094106|183010631|SUPERIORITY|||||||0.36||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 0-6 h||||0.36
91560917|NCT01094106|183010631|SUPERIORITY|||||||0.43||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 6-12 h||||0.43
91560918|NCT01094106|183010631|SUPERIORITY|||||||0.68||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 12-24 h||||0.68
91560919|NCT01094106|183010631|SUPERIORITY|||||||0.37||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 24-36 h||||0.37
91560920|NCT01094106|183010631|SUPERIORITY|||||||0.06||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 36-48 h||||0.06
91560921|NCT01094106|183010632|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
91560922|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560923|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560924|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560925|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
91560926|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560927|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91560928|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560929|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560930|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|-2.2|||||TWO_SIDED|95.0|-15.7|10.9||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-15.7|
91560931|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560932|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560933|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560934|NCT00824850|183010641|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560935|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|9.0|||||TWO_SIDED|95.0|-5.6|25.5||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||25.5|-5.6|
91560936|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560937|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
91560938|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|5.7|||||TWO_SIDED|95.0|-4.2|19.2||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||19.2|-4.2|
91560939|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
91560940|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91560941|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560942|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
91560943|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|6.9|||||TWO_SIDED|95.0|-7.4|23.4||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||23.4|-7.4|
91560944|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560945|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560946|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560947|NCT00824850|183010642|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560948|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
91560949|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91560950|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91560951|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91560952|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560953|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
91560954|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91560955|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.7|15.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.3|-6.7|
91560956|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560957|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.9|||||TWO_SIDED|95.0|-15.0|17.6||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.6|-15.0|
91560958|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91560959|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91560960|NCT00824850|183010643|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
91560961|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
91560962|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
91560963|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91560964|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
91560965|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91560966|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|-2.8|||||TWO_SIDED|95.0|-16.8|10.1||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-16.8|
91560967|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
91560968|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-7.1|15.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.0|-7.1|
91560969|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
91560970|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|1.2|||||TWO_SIDED|95.0|-14.8|18.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||18.2|-14.8|
91560971|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91560972|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-6.8|15.8||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.8|-6.8|
91560973|NCT00824850|183010644|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
91560974|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|29.47|||||TWO_SIDED|95.0|17.61|49.33|||||Confidence intervals (CI) for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||49.33|17.61|
91560975|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.34|||||TWO_SIDED|95.0|8.49|15.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.13|8.49|
91560976|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.58|||||TWO_SIDED|95.0|4.06|7.67|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.67|4.06|
91560977|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|71.09|||||TWO_SIDED|95.0|40.74|124.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||124.08|40.74|
91560978|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.91|||||TWO_SIDED|95.0|4.92|12.73|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.73|4.92|
91560979|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.56|||||TWO_SIDED|95.0|2.87|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|2.87|
91560980|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.85|||||TWO_SIDED|95.0|4.51|10.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.42|4.51|
91560981|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.98|17.64|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||17.64|6.98|
91768878|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.4|-41.1|0.364
91768879|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
91768880|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
91560982|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.68|||||TWO_SIDED|95.0|1.37|2.07|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.07|1.37|
91560983|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.52|2.9|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.90|1.52|
91560984|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.7|||||TWO_SIDED|95.0|4.77|12.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.42|4.77|
91560985|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.2|||||TWO_SIDED|95.0|4.95|10.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.48|4.95|
91560986|NCT00824850|183010645|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.02|||||TWO_SIDED|95.0|2.23|4.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.10|2.23|
91560987|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.68|||||TWO_SIDED|95.0|9.99|38.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||38.77|9.99|
91560988|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.7|||||TWO_SIDED|95.0|3.9|8.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||8.33|3.90|
91560989|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.78|||||TWO_SIDED|95.0|2.16|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.16|
91560990|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.46|||||TWO_SIDED|95.0|13.17|41.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.79|13.17|
91560991|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.68|||||TWO_SIDED|95.0|8.94|20.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||20.92|8.94|
91560992|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.98|||||TWO_SIDED|95.0|6.21|12.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.97|6.21|
91560993|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|5.91|13.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.72|5.91|
91560994|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.58|||||TWO_SIDED|95.0|5.36|10.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.72|5.36|
91560995|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.56|||||TWO_SIDED|95.0|1.3|1.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.86|1.30|
91560996|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.93|||||TWO_SIDED|95.0|1.43|2.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.60|1.43|
91768881|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-25.0||||0.063|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||-6.0|-44.0|0.063
91560997|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.46|||||TWO_SIDED|95.0|3.09|6.45|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.45|3.09|
91560998|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.32|||||TWO_SIDED|95.0|3.65|7.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.75|3.65|
91560999|NCT00824850|183010646|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.27|||||TWO_SIDED|95.0|2.49|4.28|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.28|2.49|
91561000|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.86|||||TWO_SIDED|95.0|9.16|27.46|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.46|9.16|
91561001|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.01|||||TWO_SIDED|95.0|3.5|7.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.16|3.50|
91561002|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.86|||||TWO_SIDED|95.0|2.93|5.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.09|2.93|
91561003|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.57|||||TWO_SIDED|95.0|11.11|27.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.79|11.11|
91561004|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.22|||||TWO_SIDED|95.0|2.86|6.23|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.23|2.86|
91561005|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.54|||||TWO_SIDED|95.0|1.78|3.62|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.62|1.78|
91561006|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.21|||||TWO_SIDED|95.0|2.86|6.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.19|2.86|
91561007|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.23|||||TWO_SIDED|95.0|2.79|6.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.42|2.79|
91561008|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.63|||||TWO_SIDED|95.0|1.3|2.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.05|1.30|
91561009|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.67|||||TWO_SIDED|95.0|1.3|2.14|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.14|1.30|
91561010|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.39|5.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.42|2.39|
91561011|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.41|||||TWO_SIDED|95.0|2.42|4.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.82|2.42|
91561012|NCT00824850|183010647|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.26|1.60|
91561013|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.36|||||TWO_SIDED|95.0|4.5|15.56|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.56|4.50|
91561014|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.37|||||TWO_SIDED|95.0|1.78|3.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.16|1.78|
91561015|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.02|||||TWO_SIDED|95.0|1.63|2.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.49|1.63|
91561016|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.61|||||TWO_SIDED|95.0|4.31|10.15|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.15|4.31|
91768882|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
91561017|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.92|||||TWO_SIDED|95.0|3.34|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|3.34|
91561018|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.73|||||TWO_SIDED|95.0|2.08|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.08|
91768883|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
91561019|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.82|||||TWO_SIDED|95.0|2.08|3.83|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.83|2.08|
91768884|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
91768885|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
91561020|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.79|||||TWO_SIDED|95.0|2.8|5.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.13|2.80|
91561021|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.32|||||TWO_SIDED|95.0|1.11|1.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.57|1.11|
91561022|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.61|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.61|1.05|
91561023|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.04|||||TWO_SIDED|95.0|1.51|2.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.75|1.51|
91561024|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.87|||||TWO_SIDED|95.0|2.19|3.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.77|2.19|
91561025|NCT00824850|183010648|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.95|||||TWO_SIDED|95.0|1.59|2.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.39|1.59|
91561026|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|201.8|||||TWO_SIDED|95.0|55.11|739.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||739.05|55.11|
91561027|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.7|||||TWO_SIDED|95.0|5.2|26.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||26.10|5.20|
91561028|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|156.4|||||TWO_SIDED|95.0|48.72|501.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||501.86|48.72|
91561029|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.4|||||TWO_SIDED|95.0|13.71|102.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||102.31|13.71|
91561030|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|93.9|||||TWO_SIDED|95.0|30.99|284.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||284.31|30.99|
91561031|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|48.7|||||TWO_SIDED|95.0|23.27|101.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||101.97|23.27|
91561032|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.1|||||TWO_SIDED|95.0|11.99|85.81|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||85.81|11.99|
91561033|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.1|||||TWO_SIDED|95.0|50.42|120.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.94|50.42|
91561034|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|10.3|||||TWO_SIDED|95.0|6.8|15.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.72|6.80|
91561035|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.7|||||TWO_SIDED|95.0|32.75|116.34|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||116.34|32.75|
91561036|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|536.5|||||TWO_SIDED|95.0|212.04|1357.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1357.19|212.04|
91561037|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.9|||||TWO_SIDED|95.0|33.28|410.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||410.33|33.28|
91561038|NCT00824850|183010649|SUPERIORITY_OR_OTHER||geometric mean fold rise|24.6|||||TWO_SIDED|95.0|11.3|53.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||53.42|11.30|
91561039|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|168.8|||||TWO_SIDED|95.0|20.22|1409.76|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1409.76|20.22|
91561040|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|40.3|||||TWO_SIDED|95.0|10.97|148.44|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||148.44|10.97|
91768886|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||13.0|-13.4|1.000
91768887|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|2.1||||1|TWO_SIDED|95.0|-14.4|18.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||18.7|-14.4|1.000
91768888|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
91768889|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
91768890|NCT02365649|183425725|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
91561041|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.9|||||TWO_SIDED|95.0|18.83|203.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.72|18.83|
91768891|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|30.0||||0.155|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.155
91768892|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|30.0||||0.024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.024
91768893|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-40.1|33.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.4|-40.1|1.000
91768894|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-8.6||||0.633|TWO_SIDED|95.0|-46.4|29.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.2|-46.4|0.633
91768895|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
91768896|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-24.4||||0.209|TWO_SIDED|95.0|-61.3|12.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||12.5|-61.3|0.209
91561042|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|26.7|||||TWO_SIDED|95.0|9.67|73.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.84|9.67|
91561043|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|226.9|||||TWO_SIDED|95.0|79.81|645.29|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||645.29|79.81|
91561044|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.8|||||TWO_SIDED|95.0|54.54|250.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||250.13|54.54|
91561045|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|481.0|||||TWO_SIDED|95.0|207.01|1117.69|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1117.69|207.01|
91561046|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|66.5|||||TWO_SIDED|95.0|41.8|105.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||105.75|41.80|
91561047|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.6|||||TWO_SIDED|95.0|5.36|13.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.94|5.36|
91561048|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.2|||||TWO_SIDED|95.0|41.38|147.8|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||147.80|41.38|
91561049|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|438.1|||||TWO_SIDED|95.0|169.52|1132.43|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1132.43|169.52|
91561050|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|80.0|||||TWO_SIDED|95.0|23.28|274.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||274.82|23.28|
91561051|NCT00824850|183010650|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.5|||||TWO_SIDED|95.0|28.73|131.76|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.76|28.73|
91561052|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|281.7|||||TWO_SIDED|95.0|76.65|1035.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1035.49|76.65|
91561053|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|3.47|16.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||16.75|3.47|
91561054|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|151.4|||||TWO_SIDED|95.0|42.01|545.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||545.84|42.01|
91561055|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.7|||||TWO_SIDED|95.0|8.67|64.54|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||64.54|8.67|
91561056|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|102.1|||||TWO_SIDED|95.0|32.0|325.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||325.40|32.00|
91561057|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|31.1|||||TWO_SIDED|95.0|12.71|76.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||76.13|12.71|
91561058|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|18.7|||||TWO_SIDED|95.0|6.82|51.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||51.39|6.82|
91561059|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|64.4|||||TWO_SIDED|95.0|37.33|111.18|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||111.18|37.33|
91561060|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.64|18.52|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||18.52|6.64|
91561061|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|41.2|||||TWO_SIDED|95.0|23.09|73.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.48|23.09|
91561062|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|479.6|||||TWO_SIDED|95.0|171.63|1339.96|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1339.96|171.63|
91561063|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|76.4|||||TWO_SIDED|95.0|21.63|270.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||270.02|21.63|
91561064|NCT00824850|183010651|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.7|||||TWO_SIDED|95.0|7.61|41.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.08|7.61|
91561065|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|170.2|||||TWO_SIDED|95.0|22.24|1301.79|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1301.79|22.24|
91561066|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.8|||||TWO_SIDED|95.0|5.27|59.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||59.91|5.27|
91561067|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|67.8|||||TWO_SIDED|95.0|18.45|249.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||249.02|18.45|
91561068|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.2|||||TWO_SIDED|95.0|7.94|61.88|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||61.88|7.94|
91561069|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|205.5|||||TWO_SIDED|95.0|70.04|602.78|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||602.78|70.04|
91561070|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|90.5|||||TWO_SIDED|95.0|40.28|203.27|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.27|40.28|
91561071|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|91.7|||||TWO_SIDED|95.0|36.25|232.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||232.13|36.25|
91561072|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|75.6|||||TWO_SIDED|95.0|47.32|120.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.91|47.32|
91561073|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.7|||||TWO_SIDED|95.0|5.21|14.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||14.40|5.21|
91561074|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|60.0|||||TWO_SIDED|95.0|31.06|115.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||115.92|31.06|
91561075|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|269.8|||||TWO_SIDED|95.0|105.09|692.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||692.60|105.09|
91561076|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.7|||||TWO_SIDED|95.0|10.85|131.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.09|10.85|
91561077|NCT00824850|183010652|SUPERIORITY_OR_OTHER||geometric mean fold rise|44.8|||||TWO_SIDED|95.0|21.31|94.01|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||94.01|21.31|
91561078|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.97|||||TWO_SIDED|95.0|1.31|2.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.95|1.31|
91768897|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|25.0||||0.283|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.283
91768898|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
91561079|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.95|||||TWO_SIDED|95.0|1.78|4.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.90|1.78|
91768899|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-41.7||||0.048|TWO_SIDED|95.0|-77.8|-5.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-5.5|-77.8|0.048
91561080|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.85|||||TWO_SIDED|95.0|1.25|2.75|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.75|1.25|
91561081|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.24|||||TWO_SIDED|95.0|1.11|4.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.53|1.11|
91561082|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.63|||||TWO_SIDED|95.0|0.38|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.05|0.38|
91561083|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.50|
91561084|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.83|||||TWO_SIDED|95.0|0.48|1.43|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.43|0.48|
91561085|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.00|0.96|
91561086|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.25|||||TWO_SIDED|95.0|0.79|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.96|0.79|
91561087|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.54|1.52|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.52|0.54|
91768900|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|21.4||||0.408|TWO_SIDED|95.0|-18.6|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||61.4|-18.6|0.408
91561088|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.81|||||TWO_SIDED|95.0|0.98|3.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.34|0.98|
91561089|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.72|||||TWO_SIDED|95.0|1.05|2.83|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.83|1.05|
91561090|NCT00824850|183010653|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.67|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.67|
91561091|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.18|||||TWO_SIDED|95.0|1.26|3.79|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.79|1.26|
91561092|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|3.13|||||TWO_SIDED|95.0|1.84|5.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||5.32|1.84|
91768901|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
91768902|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-16.7||||0.454|TWO_SIDED|95.0|-54.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||21.1|-54.5|0.454
91768903|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|35.7||||0.183|TWO_SIDED|95.0|1.8|69.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.7|1.8|0.183
91768904|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
91561093|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.68|||||TWO_SIDED|95.0|1.13|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.51|1.13|
91561094|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.96|||||TWO_SIDED|95.0|0.95|4.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.07|0.95|
91561095|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.51|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.56|0.51|
91561096|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.58|||||TWO_SIDED|95.0|0.93|2.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.66|0.93|
91561097|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.62|||||TWO_SIDED|95.0|0.97|2.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.73|0.97|
91561098|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.41|||||TWO_SIDED|95.0|0.83|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.39|0.83|
91561099|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.44|||||TWO_SIDED|95.0|0.89|2.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.34|0.89|
91561100|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.68|1.64|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.64|0.68|
91561101|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.88|||||TWO_SIDED|95.0|1.05|3.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.35|1.05|
91561102|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.48|||||TWO_SIDED|95.0|0.9|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.90|
91561103|NCT00824850|183010654|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.11|||||TWO_SIDED|95.0|0.75|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.75|
91561104|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.5|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.17|0.50|
91561105|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.73|0.70|
91768905|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-44.7|33.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.6|-44.7|1.000
91768906|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|33.3||||0.307|TWO_SIDED|95.0|-9.7|76.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||76.3|-9.7|0.307
91561106|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.61|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.15|0.61|
91561107|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.56|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.25|0.56|
91561108|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.51|1.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.40|0.51|
91561109|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.32|1.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.12|0.32|
91561110|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.85|0.38|
91561111|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.75|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.22|0.75|
91561112|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.82|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.61|0.82|
91561113|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.36|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.13|0.36|
91561114|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.55|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.39|0.55|
91561115|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.73|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.70|0.73|
91561116|NCT00824850|183010655|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.5|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.63|0.50|
91561117|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.35|1.27|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.27|0.35|
91561118|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.77|2.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.05|0.77|
91561119|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.54|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.44|0.54|
91561120|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.95|0.38|
91561121|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.64|1.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.91|0.64|
91561122|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.28|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.28|
91561123|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.68|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.81|0.68|
91561124|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.53|1.77|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.77|0.53|
91561125|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.69|1.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.81|0.69|
91561126|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.32|1.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.85|0.32|
91561127|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.8|2.36|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.36|0.80|
91561128|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.65|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.65|
91561129|NCT00824850|183010656|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.46|1.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.57|0.46|
91561130|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
91561131|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91561132|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91561133|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91561134|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91561135|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91561136|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91561137|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91561138|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91561139|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
91561140|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91768907|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|33.3||||0.172|TWO_SIDED|95.0|-4.1|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-4.1|0.172
91561141|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91561142|NCT00824850|183010659|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91561143|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
91561144|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
91561145|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91561146|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
91561147|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91561148|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.1|10.5||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.5|-10.1|
91561149|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
91561150|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
91561151|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
91561152|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|3.3|||||TWO_SIDED|95.0|-8.6|17.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.2|-8.6|
91561153|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91561154|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.7|10.6||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-9.7|
91561155|NCT00824850|183010660|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
91561156|NCT03072238|183010668|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0335|TWO_SIDED|95.0|0.61|0.98|||Log Rank|||||0.98|0.61|0.0335
91561157|NCT03072238|183010669|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0431|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||||0.99|0.71|0.0431
91561158|NCT03072238|183010670|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.5698|TWO_SIDED|95.0|0.76|1.17|||Log Rank|||||1.17|0.76|0.5698
91561159|NCT03072238|183010671|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2515|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2515
91561160|NCT03072238|183010672|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.601|TWO_SIDED|95.0|0.58|1.01|||Log Rank|||||1.01|0.58|0.6010
91561161|NCT03072238|183010673|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1723|TWO_SIDED|95.0|0.72|1.06|||Log Rank|||||1.06|0.72|0.1723
91561162|NCT03072238|183010674|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1566|TWO_SIDED|95.0|0.65|1.07|||Log Rank|||||1.07|0.65|0.1566
91561163|NCT03072238|183010675|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0419|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.0419
91561164|NCT03072238|183010676|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3198|TWO_SIDED|95.0|0.89|1.45|||Log Rank|||||1.45|0.89|0.3198
91561165|NCT03072238|183010677|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.0071|TWO_SIDED|95.0|1.06|1.47|||Log Rank|||||1.47|1.06|0.0071
91561166|NCT03072238|183010678|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0045|TWO_SIDED|95.0|0.59|0.91|||Log Rank|||||0.91|0.59|0.0045
91561167|NCT03072238|183010679|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Log Rank|||||0.83|0.61|< 0.0001
91561168|NCT03072238|183010680|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.1359|TWO_SIDED|95.0|0.57|1.08|||Log Rank|||||1.08|0.57|0.1359
91561169|NCT03072238|183010681|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1398|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|0.68|0.1398
91561170|NCT03072238|183010682|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8239|TWO_SIDED|95.0|0.61|1.48|||Log Rank|||||1.48|0.61|0.8239
91561171|NCT03072238|183010683|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6018|TWO_SIDED|95.0|0.66|1.27|||Log Rank|||||1.27|0.66|0.6018
91561172|NCT03072238|183010684|SUPERIORITY||Difference in Overall Response Rate|20.93||||0.003|TWO_SIDED|95.0|6.2|35.65|||Cochran-Mantel-Haenszel|||||35.65|6.20|0.0030
91561173|NCT03072238|183010685|SUPERIORITY||Difference in Overall Response Rate|16.46||||0.0008|TWO_SIDED|95.0|6.66|26.27|||Cochran-Mantel-Haenszel|||||26.27|6.66|0.0008
91561174|NCT03072238|183010688|SUPERIORITY||Difference in Overall Response Rate|11.81||||0.0012|TWO_SIDED|95.0|4.34|19.29|||Cochran-Mantel-Haenszel|||||19.29|4.34|0.0012
91561175|NCT03072238|183010689|SUPERIORITY||Difference in Overall Response Rate|5.87||||0.0178|TWO_SIDED|95.0|0.83|10.9|||Cochran-Mantel-Haenszel|||||10.90|0.83|0.0178
91561176|NCT03072238|183010690|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0246|TWO_SIDED|95.0|0.45|0.95|||Log Rank|||||0.95|0.45|0.0246
91561177|NCT01574105|183010695|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes of 26 in heparin resistant group and 26 in heparin sensitive group achieve 90% power at the 0.025 level of significance to detect a non-inferiority using a one-sided two-sample t-test, assuming a noninferiority margin is 200 milliliters in the postoperative chest tube loss.|||||<|0.1||95.0|||||ANCOVA|||For the analysis of the patient characteristics Wilcoxon, Chi-square and Fischer's exact tests were used. An upper bound of a two-sided 95% confidence interval (CI) of the mean difference between resistant and sensitive groups for all values of chest tube losses was computed by analysis of covariance (ANCOVA), and compared with pre-specified noninferiority limits. Covariates in the ANCOVA model included patient characteristics differing between two groups with a p-value \<0.1.||||<0.1
91561178|NCT00608959|183010697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91|STANDARD_DEVIATION|1.563|<|0.001||95.0|-2.55|-1.26|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.26|-2.55|<0.001
91561179|NCT00608959|183010697|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.656|<|0.001||95.0|-2.57|-1.17|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.17|-2.57|<0.001
91561180|NCT03884478|183010727|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.0001
91561181|NCT03884478|183010727|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.77||0.005|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Control Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.005
91561182|NCT03884478|183010727|OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.82||0.25|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol Only Arm.||||.25
91561183|NCT03884478|183010728|OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.84||0.025|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.025
91561184|NCT03884478|183010728|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.79||0.11|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.11
91561185|NCT03884478|183010728|OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.66
91561186|NCT03884478|183010729|OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
91561187|NCT03884478|183010729|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
91768908|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||55.1|-40.9|1.000
91561188|NCT03884478|183010729|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.88
91768909|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-27.8|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.5|-27.8|1.000
91768910|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-11.7||||0.675|TWO_SIDED|95.0|-51.5|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.1|-51.5|0.675
91768911|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-12.9||||0.644|TWO_SIDED|95.0|-59.2|33.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||33.5|-59.2|0.644
91768912|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-50.6|1.000
91768913|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.0|-33.4|1.000
91768914|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||55.1|-40.9|1.000
91561189|NCT03884478|183010730|OTHER||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.03
91561190|NCT03884478|183010730|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.24||0.059|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.059
91561191|NCT03884478|183010730|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.71|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.71
91561192|NCT03884478|183010731|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
91561193|NCT03884478|183010731|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
91561194|NCT03884478|183010731|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.19||0.87|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.87
91768915|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.6|-50.6|1.000
91768916|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.0|-33.4|1.000
91768917|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||55.1|-40.9|1.000
91768918|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-40.2|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||60.2|-40.2|1.000
91768919|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|18.3||||0.392|TWO_SIDED|95.0|-22.9|59.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||59.6|-22.9|0.392
91768920|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-44.7|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-44.7|1.000
91768921|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|29.0||||0.07|TWO_SIDED|95.0|6.5|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||51.5|6.5|0.070
91561195|NCT03884478|183010732|OTHER||Median Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
91561196|NCT03884478|183010732|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.002
91561197|NCT03884478|183010732|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.43
91561198|NCT00828139|183010813|SUPERIORITY_OR_OTHER||3-month PFS|0.24|||||TWO_SIDED|90.0|0.14|0.37|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier. The 3-month PFS estimated value corresponds to the probability of PFS at month 3.||0.37|0.14|
91561199|NCT00828139|183010813|SUPERIORITY_OR_OTHER||3-month PFS|0.15|||||TWO_SIDED|90.0|0.07|0.27|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.27|0.07|
91561200|NCT00828139|183010813|SUPERIORITY_OR_OTHER||3-month PFS|0.27|||||TWO_SIDED|90.0|0.18|0.39|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.39|0.18|
91561201|NCT00828139|183010813|SUPERIORITY_OR_OTHER||3-month PFS|0.1|||||TWO_SIDED|90.0|0.04|0.2|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.2|0.04|
91561202|NCT00828139|183010813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|90.0|0.91|1.92||||||Hazard Ratio was evaluated using a logrank test.||1.92|0.91|
91561203|NCT00828139|183010813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|90.0|1.08|2.1||||||Hazard Ratio was evaluated using log-rank test.||2.10|1.08|
91561204|NCT01129011|183010858|SUPERIORITY_OR_OTHER||proportions|11.9||||0.001|TWO_SIDED|95.0|7.9|17.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||17.1|7.9|0.001
91768922|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|29.5||||0.007|TWO_SIDED|95.0|9.8|49.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.2|9.8|0.007
91768923|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|3.3||||0.826|TWO_SIDED|95.0|-26.1|32.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.8|-26.1|0.826
91561205|NCT01129011|183010859|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91561206|NCT01129011|183010860|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||||||0.009
91561207|NCT01129011|183010861|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
91561208|NCT01129011|183010862|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91561209|NCT00841321|183010875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1|TWO_SIDED|95.0|-0.5|0.1||Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||PASAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.1|-0.5|.1
91561210|NCT00841321|183010875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.9|-0.1||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||Stroop Exit Z-score least square means difference adjusted for baseline.Positive values indicate a beneficial effect from treatment with Ginkgo.||-0.1|-0.9|0.007
91561211|NCT00841321|183010875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|95.0|-0.2|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||COWAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.2|0.5
91561212|NCT00841321|183010875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.5||95.0|-0.3|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||CVLT-II Delayed Recall Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.3|0.5
91561213|NCT00841321|183010875|SUPERIORITY_OR_OTHER|||||||0.19|||||||MANCOVA|MANCOVA||MANCOVA for all four cognitive tests at exit adjusting for baseline. Individual ANOVAs were to follow if the multivariate test was significant.||||0.19
91561214|NCT00841321|183010876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.4|TWO_SIDED|95.0|-5.7|4.7|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Perceived Deficits Questionnaire||4.7|-5.7|0.4
91561215|NCT00841321|183010876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.0||0.7||95.0|-3.2|4.8|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Multiple Sclerosis Neuropsychological Questionnaire||4.8|-3.2|0.7
91561216|NCT00841321|183010876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.6||0.4||95.0|-1.3|0.8|||ANCOVA|||Community Integration Questionnaire||0.8|-1.3|0.4
91561217|NCT01358175|183010881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.2|6.42|||Regression, Logistic|||||6.42|2.20|<0.0001
91768924|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|0.3||||1|TWO_SIDED|95.0|-27.2|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||27.7|-27.2|1.000
91561218|NCT01358175|183010881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.89|||<|0.0001|TWO_SIDED|95.0|2.28|6.65|||Regression, Logistic|||||6.65|2.28|<0.0001
91561219|NCT04908488|183010889|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Means Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||-0.01|||Mixed effects repeated measures model|Within subject correlation due to eye and the crossover design were accounted for in the model.|Lens difference (P1fA minus AMfA)|||-0.01||
91768925|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-5.2||||0.649|TWO_SIDED|95.0|-27.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-27.8|0.649
91561220|NCT01107912|183010890|NON_INFERIORITY_OR_EQUIVALENCE|The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.|Estimate of the difference|6.0|||||TWO_SIDED|95.0|1.0|9.0||||||||9.00|1.00|
91561221|NCT02432183|183010895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||Kruskal-Wallis|post-hoc comparison with Dunn's multiple comparison test: p=0.0326 between arm 1 and 2; p=0.0147 between arm 1 and 3||||||0.0061
91561222|NCT03875729|183010900|SUPERIORITY||Mean Difference (Net)|0.1253|||<|0.001|TWO_SIDED|95.0|0.0852|0.1653||ITT: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = Teplizumab - Placebo|This study was designed to show a difference of at least a 40% in C-peptide response between teplizumab and placebo. In geometric means, this translates to a value of (1.4×0.28) = 0.392. Consequently, approximately 300 participants were planned for enrollment, assuming 2-sided α=0.05, 90% power, 2:1 randomization, and a 10% dropout rate.||0.1653|0.0852|<0.001
91561223|NCT03875729|183010900|SUPERIORITY||Mean Difference (Net)|0.1385|||<|0.001|TWO_SIDED|95.0|0.0994|0.1776||PP: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = teplizumab - placebo|||0.1776|0.0994|<0.001
91561224|NCT03875729|183010901|SUPERIORITY||Mean Difference (Final Values)|-0.131||||0.085|TWO_SIDED|95.0|-0.28|0.018||ITT: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.018|-0.280|0.085
91561225|NCT03875729|183010901|SUPERIORITY||Mean Difference (Final Values)|-0.167|||<|0.001|TWO_SIDED|95.0|-0.256|-0.078||PP: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||-0.078|-0.256|<0.001
91561226|NCT03875729|183010902|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.606|TWO_SIDED|95.0|-0.42|0.24||ITT: ANCOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA|||||0.24|-0.42|0.606
91561227|NCT03875729|183010902|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.2||PP: ANOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.20|-0.46|0.454
91561228|NCT03875729|183010903|SUPERIORITY||Mean Difference (Final Values)|4.71||||0.151|TWO_SIDED|95.0|-1.72|11.15||ITT: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||11.15|-1.72|0.151
91561229|NCT03875729|183010903|SUPERIORITY||Mean Difference (Final Values)|6.17||||0.045|TWO_SIDED|95.0|0.13|12.22||PP: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||12.22|0.13|0.045
91561230|NCT03875729|183010904|SUPERIORITY||Rate ratio|1.1||||0.634|TWO_SIDED|95.0|0.74|1.64||ITT: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment, age group at randomization, and screening peak C-peptide category as independent variables.|Negative binomial regression model||Rate ratio = teplizumab / placebo.|||1.64|0.74|0.634
91561231|NCT03875729|183010904|SUPERIORITY||Rate ratio|1.09||||0.69|TWO_SIDED|95.0|0.72|1.65||PP: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment age group at randomization, and screening peak C-peptide category as independent variables.|Rate ratio||Rate ratio = teplizumab / placebo.|||1.65|0.72|0.690
91768926|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-16.7||||0.304|TWO_SIDED|95.0|-45.7|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.4|-45.7|0.304
91768927|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|10.3||||0.72|TWO_SIDED|95.0|-18.2|38.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||38.7|-18.2|0.720
91561232|NCT01280656|183010920|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
91768928|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|1.2||||0.923|TWO_SIDED|95.0|-23.0|25.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||25.4|-23.0|0.923
91768929|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-20.0||||0.197|TWO_SIDED|95.0|-50.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||10.4|-50.4|0.197
91768930|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|11.5||||0.486|TWO_SIDED|95.0|-20.4|43.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||43.5|-20.4|0.486
91768931|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|17.9||||0.168|TWO_SIDED|95.0|-7.0|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||42.7|-7.0|0.168
91561233|NCT01280656|183010921|SUPERIORITY_OR_OTHER|||||||0.693|||||||Chi-squared|||||||0.693
91561234|NCT01280656|183010923|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Chi-squared|||||||0.573
91561235|NCT01280656|183010925|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Chi-squared|||Mean at the site||||0.982
91561236|NCT01280656|183010925|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||Mean at home||||0.012
91561237|NCT01280656|183010926|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Responders vs Non-responders||||0.476
91561238|NCT01280656|183010926|SUPERIORITY_OR_OTHER|||||||0.32|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.320
91561239|NCT01280656|183010927|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Chi-squared|||||||0.792
91561240|NCT01280656|183010928|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
91561241|NCT01280656|183010929|SUPERIORITY_OR_OTHER|||||||0.921|TWO_SIDED||||||Chi-squared|||||||0.921
91561242|NCT01280656|183010930|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
91561243|NCT01280656|183010931|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||Chi-squared|||Total||||0.973
91561244|NCT05265247|183010935|EQUIVALENCE|The two formulations were considered to be bioequivalent if the point estimate for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9531|||||TWO_SIDED|90.0|0.851|1.0673||||||||1.0673|0.8510|
91561245|NCT05265247|183010936|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% 2-sided confidence interval (CI) for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9538|||||TWO_SIDED|90.0|0.898|1.0132||||||||1.0132|0.8980|
91561246|NCT02516202|183010944|SUPERIORITY|||||||0.25||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.25
91561247|NCT02516202|183010944|SUPERIORITY|||||||0.31||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.31
91561248|NCT02516202|183010945|SUPERIORITY|||||||0.99||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.99
91561249|NCT02516202|183010945|SUPERIORITY|||||||0.05||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.05
91561250|NCT02516202|183010946|SUPERIORITY|||||||0.64||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.64
91561251|NCT02516202|183010946|SUPERIORITY|||||||0.17||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.17
91561252|NCT02516202|183010948|SUPERIORITY|||||||0.02||||||p-value calculation includes 195 participants with known responses at week 12.|Chi-squared|||||||0.02
91561253|NCT02516202|183010949|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91561254|NCT02516202|183010949|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
91561255|NCT02516202|183010950|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91561256|NCT02516202|183010950|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91561257|NCT02841449|183010951|OTHER|||||||0.886|||||||t-test, 2 sided|paired sample||||||0.886
91561258|NCT02841449|183010951|OTHER|||||||0.43||||||The above is the trial\*time interaction. trial, p = 0.627; time, p \< 0.001|ANOVA|repeated measures||||||0.430
91561259|NCT02841449|183010952|OTHER|||||||0.369|||||||t-test, 2 sided|paired samples||||||0.369
91561260|NCT02841449|183010952|OTHER|||||||0.859||||||The above is the trial\*time interaction. trial p = 0.200; time p \< 0.001|ANOVA|repeated measures||||||0.859
91561261|NCT02841449|183010953|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||<0.001
91561262|NCT02841449|183010953|OTHER|||||||0.261||||||The above is the trial\*time interaction. trial p = 0.002; time p = 0.282|ANOVA|repeated measures||||||0.261
91561263|NCT02841449|183010954|OTHER|||||||0.736|||||||t-test, 2 sided|paired samples||||||0.736
91561264|NCT02841449|183010955|OTHER|||||||0.542|||||||t-test, 2 sided|paired samples||||||0.542
91561265|NCT02841449|183010956|OTHER|||||||0.4|||||||t-test, 2 sided|paired samples||||||0.400
91561266|NCT02841449|183010957|OTHER|||||||0.646|||||||ANOVA|repeated measures||Visual analogue scale for thirst||||0.646
91561267|NCT02841449|183010957|OTHER|||||||0.403|||||||ANOVA|repeated measures||visual analogue scale for desire for savoury||||0.403
91561268|NCT02841449|183010957|OTHER|||||||0.022|||||||ANOVA|repeated measures||visual analogue scale for desire for salt||||0.022
91561269|NCT02841449|183010957|OTHER|||||||0.849|||||||ANOVA|repeated measures||visual analogue scale for hunger||||0.849
91561270|NCT02841449|183010957|OTHER|||||||0.062|||||||ANOVA|repeated measures||visual analogue scale for fullness||||0.062
91561271|NCT02841449|183010957|OTHER|||||||0.549|||||||ANOVA|repeated measures||visual analogue scale for how much participants felt they could eat||||0.549
91561272|NCT02841449|183010957|OTHER|||||||0.402|||||||ANOVA|repeated measures||visual analogue scale for sweet desire||||0.402
91561273|NCT02841449|183010957|OTHER|||||||0.138|||||||ANOVA|repeated measures||visual analogue scale for fatty food desire||||0.138
91561274|NCT02841449|183010958|OTHER|||||||0.055||||||Above is trial\*time effect. trial p = 0.135; time p = 0.011|ANOVA|repeated measures||||||0.055
91561275|NCT02841449|183010959|OTHER|||||||0.226|||||||t-test, 2 sided|paired sample||||||0.226
91561276|NCT02841449|183010960|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||< 0.001
91561277|NCT02707952|183011005|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of -10%, then arm A was considered non-inferior to arm B.|Rate Difference|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||95% CI was calculated using the normal approximation to the binomial distribution.|||0.9|-2.8|
91561278|NCT03015220|183011076|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.5||||0.2963|TWO_SIDED|95.0|0.7|3.2||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.20|0.70|0.2963
91561279|NCT03015220|183011076|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.8||||0.5997|TWO_SIDED|95.0|0.35|1.83||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.83|0.35|0.5997
91561280|NCT03015220|183011076|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.55||||0.1871|TWO_SIDED|95.0|0.23|1.33||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.33|0.23|0.1871
91561281|NCT03015220|183011077|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.9||||0.1672|TWO_SIDED|95.0|0.76|4.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||4.72|0.76|0.1672
91561282|NCT03015220|183011077|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.6||||0.3391|TWO_SIDED|95.0|0.21|1.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.72|0.21|0.3391
91561283|NCT03015220|183011077|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.12||||0.011|TWO_SIDED|95.0|0.02|0.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.62|0.02|0.0110
91561284|NCT02312258|183011097|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.473|TWO_SIDED|95.0|0.861|1.381|||Log Rank||||"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), International Staging System (ISS) stage before initial therapy (stage I or II vs stage III), age (\<75 versus \[vs\] \>=75 years) at randomization, and best response to initial therapy (complete response (CR) or very good partial response (VGPR) vs partial response (PR)).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 versus\[vs\] \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.381|0.861|=0.473
91561285|NCT02312258|183011099|SUPERIORITY||Hazard Ratio (HR)|0.655|||<|0.001|TWO_SIDED|95.0|0.537|0.799|||Log Rank||||"P-value comparing TTP between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.799|0.537|<0.001
91561286|NCT02312258|183011100|SUPERIORITY||Hazard Ratio (HR)|0.984|||=|0.893|TWO_SIDED|95.0|0.777|1.246|||Log Rank||||"P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.246|0.777|=0.893
91561287|NCT02312258|183011101|SUPERIORITY||Hazard Ratio (HR)|0.777|||=|0.018|TWO_SIDED|95.0|0.631|0.957|||Log Rank||||"P-value comparing TTNT between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.957|0.631|=0.018
91561288|NCT02312258|183011102|SUPERIORITY||Hazard Ratio (HR)|1.111|||=|0.462|TWO_SIDED|95.0|0.839|1.47|||Log Rank||||"P-value comparing Time to End of Next Line Therapy between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.470|0.839|=0.462
91561289|NCT02312258|183011103|SUPERIORITY||Hazard Ratio (HR)|1.293|||||TWO_SIDED|95.0|0.968|1.727|||||||Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.|1.727|0.968|
91768932|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|-3.3||||0.833|TWO_SIDED|95.0|-34.3|27.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.6|-34.3|0.833
91768933|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|22.6||||0.173|TWO_SIDED|95.0|-8.2|53.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.4|-8.2|0.173
91768934|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|17.6||||0.178|TWO_SIDED|95.0|-7.6|42.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||42.8|-7.6|0.178
91561290|NCT02312258|183011106|SUPERIORITY||Hazard Ratio (HR)|0.582|||=|0.001|TWO_SIDED|95.0|0.425|0.796|||Log Rank|||PFS for Participants with Known MRD+ at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.796|0.425|=0.001
91561291|NCT02312258|183011106|SUPERIORITY||Hazard Ratio (HR)|1.537|||=|0.398|TWO_SIDED|95.0|0.563|4.194|||Log Rank|||PFS for Participants with Known MRD- at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|4.194|0.563|=0.398
91561292|NCT02312258|183011106|SUPERIORITY||Hazard Ratio (HR)|10.173|||=|0.012|TWO_SIDED|95.0|1.194|86.649|||Log Rank|||OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|86.649|1.194|=0.012
91561293|NCT02312258|183011108|SUPERIORITY||Hazard Ratio (HR)|1.011|||=|0.963|TWO_SIDED|95.0|0.631|1.621|||Log Rank||||"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.621|0.631|=0.963
91561294|NCT02312258|183011112|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.387|0.727|||Log Rank|||PFS Based on Frailty Status of Fit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.727|0.387|<0.001
91561295|NCT02312258|183011112|SUPERIORITY||Hazard Ratio (HR)|0.746|||=|0.098|TWO_SIDED|95.0|0.526|1.058|||Log Rank|||PFS Based on Frailty Status of Unfit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.058|0.526|=0.098
91768935|NCT02365649|183425726|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-30.9|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANCOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||30.9|-30.9|1.000
91768936|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||16.3|-71.9|0.580
91768937|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-6.9||||1|TWO_SIDED|95.0|-53.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||39.7|-53.6|1.000
91768938|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||23.3|-72.2|0.580
91561296|NCT02312258|183011112|SUPERIORITY||Hazard Ratio (HR)|0.733|||=|0.147|TWO_SIDED|95.0|0.481|1.117|||Log Rank|||PFS Based on Frailty Status of Frail|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.117|0.481|=0.147
91561297|NCT02312258|183011112|SUPERIORITY||Hazard Ratio (HR)|0.897|||=|0.714|TWO_SIDED|95.0|0.502|1.602|||Log Rank|||OS Based on Frailty Status of Fit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.602|0.502|=0.714
91561298|NCT02312258|183011112|SUPERIORITY||Hazard Ratio (HR)|1.75|||=|0.124|TWO_SIDED|95.0|0.85|3.601|||Log Rank|||OS Based on Frailty Status of Unfit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|3.601|0.850|=0.124
91561299|NCT02312258|183011112|SUPERIORITY||Hazard Ratio (HR)|0.854|||=|0.63|TWO_SIDED|95.0|0.448|1.627|||Log Rank|||OS Based on Frailty Status of Frail|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.627|0.448|=0.630
91561300|NCT01528605|183011126|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
91561301|NCT01528605|183011127|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
91561302|NCT01528605|183011128|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||"The null hypothesis is no group difference"||||>0.05
91561303|NCT01970527|183011135|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
91561304|NCT01970527|183011137|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
91561305|NCT01974102|183011138|SUPERIORITY||||||<|0.015|||||||t-test, 2 sided|||||||<0.015
91561306|NCT01974102|183011139|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
91561307|NCT00882050|183011144|OTHER|||||||0.05|||||||Regression, Logistic|||logistic regression|Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.|||0.05
91561308|NCT00882050|183011144|SUPERIORITY|Demographic data analyzed with nominal data tested by chi-square, ordinal data by Mann-Whitney, and normal data by t-test. Further, a linear regression analysis to determine the effect of intervention dose on glucose level and typical confounders such as age, weight, and type of surgery was completed. Adverse and SAEs were analyzed by chi-square for occurrence.||||||0.05||||||Due to have 3 trial groups our p value was adjusted for multiple comparisons as a a priori threshold (if a single comparison) was 0.05.|Regression, Logistic|The regression (see above) is a secondary analysis. Groups had been stratified on diabetic (y/n) to balance this potential confounder||Primary t tests of glucose between the 3 groups at 90 minutes post. Secondary MANOVA to determine the effect over time. Change in mean glucose of 20 mg/dl between all groups detectable by 18 subjects per group assuming a SD of 20mg/dl., an 82% power with an alpha of 0.05. Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.||||0.05
91561309|NCT01782209|183011145|OTHER||Incidence|17.3|||||TWO_SIDED|95.0|13.4|21.8|||||95% Clopper-Pearson Confidence Interval|||21.8|13.4|
91561310|NCT00674609|183011198|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.67||||0.014|TWO_SIDED|95.0|-1.21|-0.14|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||-0.14|-1.21|0.014
91561311|NCT00674609|183011198|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.244|TWO_SIDED|95.0|-0.86|0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||0.22|-0.86|0.244
91561312|NCT00674609|183011199|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.31||||0.346|TWO_SIDED|95.0|-0.97|0.34|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.34|-0.97|0.346
91561313|NCT00674609|183011199|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.95|TWO_SIDED|95.0|-0.64|0.68|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.68|-0.64|0.95
91561314|NCT00674609|183011200|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.49||||0.11|TWO_SIDED|95.0|-0.11|1.09|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.09|-0.11|0.11
91561315|NCT00674609|183011200|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.46||||0.126|TWO_SIDED|95.0|-0.13|1.05|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.05|-0.13|0.126
91561316|NCT00674609|183011201|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.65||||0.045|TWO_SIDED|95.0|0.01|1.28|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.28|0.01|0.045
91561317|NCT00674609|183011201|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.62||||0.053|TWO_SIDED|95.0|-0.01|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|-0.01|0.053
91561318|NCT00674609|183011202|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.83||||0.016|TWO_SIDED|95.0|0.16|1.51|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.51|0.16|0.016
91561319|NCT00674609|183011202|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.66||||0.056|TWO_SIDED|95.0|-0.02|1.33|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.33|-0.02|0.056
91561320|NCT00674609|183011203|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.68||||0.021|TWO_SIDED|95.0|0.1|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|0.10|0.021
91768939|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-38.9||||0.287|TWO_SIDED|95.0|-83.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||5.2|-83.0|0.287
91561321|NCT00674609|183011203|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|0.64||||0.028|TWO_SIDED|95.0|0.07|1.22|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.22|0.07|0.028
91768940|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-53.0|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||41.9|-53.0|1.000
91768941|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-15.6||||1|TWO_SIDED|95.0|-69.4|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||38.3|-69.4|1.000
91561322|NCT00674609|183011204|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|2.47||||0.443|TWO_SIDED|95.0|-3.87|8.81|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||8.81|-3.87|0.443
91561323|NCT00674609|183011204|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.84||||0.793|TWO_SIDED|95.0|-5.46|7.13|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||7.13|-5.46|0.793
91561324|NCT00674609|183011205|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.04||||0.619|TWO_SIDED|95.0|-5.23|3.15|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||3.15|-5.23|0.619
91561325|NCT00674609|183011205|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.07||||0.048|TWO_SIDED|95.0|-8.1|-0.05|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||-0.05|-8.10|0.048
91561326|NCT00674609|183011206|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.04||||0.688|TWO_SIDED|95.0|-0.25|0.16|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.16|-0.25|0.688
91561327|NCT00674609|183011206|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.01||||0.899|TWO_SIDED|95.0|-0.19|0.22|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.22|-0.19|0.899
91561328|NCT02301299|183011243|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the early hospital arrival would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG.||The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly early arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
91768942|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||16.3|-71.9|0.580
91768943|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||53.0|-41.9|1.000
91768944|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||23.3|-72.2|0.580
91768945|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-44.4||||0.103|TWO_SIDED|95.0|-76.9|-12.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-12.0|-76.9|0.103
91768946|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||53.0|-41.9|1.000
91768947|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-4.4||||1|TWO_SIDED|95.0|-58.3|49.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||49.4|-58.3|1.000
91768948|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-48.7|48.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||48.7|-48.7|1.000
91768949|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|16.7||||0.637|TWO_SIDED|95.0|-29.7|63.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.0|-29.7|0.637
91768950|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-60.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.3|-60.0|1.000
91768951|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||66.6|-29.4|0.570
91768952|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||10.2|-39.7|0.330
91768953|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-40.0|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||19.4|-40.0|1.000
91768954|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||66.6|-29.4|0.570
91768955|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.7|0.330
91561329|NCT02301299|183011244|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the EMS use would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|||The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
91561330|NCT00476151|183011277|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|95.0|||||ANCOVA|||||||0.083
91561331|NCT02068352|183011280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|11.93||||0.069|TWO_SIDED|95.0|-0.08|23.95||P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||23.95|-0.08|0.0690
91561332|NCT02068352|183011280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|18.23||||0.0165|TWO_SIDED|95.0|4.99|31.46||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||31.46|4.99|0.0165
91561333|NCT02068352|183011280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|12.3||||0.0617|TWO_SIDED|95.0|0.06|24.53||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||24.53|0.06|0.0617
91561334|NCT02068352|183011281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47||||0.0128|TWO_SIDED|95.0|-0.84|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, and interaction of treatment by visit as terms, Baseline score as a covariate.||||-0.10|-0.84|0.0128
91561335|NCT02068352|183011281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46||||0.0134|TWO_SIDED|95.0|-0.81|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.10|-0.81|0.0134
91561336|NCT02068352|183011282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0048|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.85|0.0048
91561337|NCT02068352|183011282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0045|TWO_SIDED|95.0|-0.84|-0.16|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.84|0.0045
91768956|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||35.4|-33.8|1.000
91768957|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-1.4||||1|TWO_SIDED|95.0|-42.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||39.7|-42.6|1.000
91768958|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-21.4||||0.1|TWO_SIDED|95.0|-42.9|0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||0.1|-42.9|0.100
91561338|NCT02068352|183011284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.26||||0.4173|TWO_SIDED|95.0|-8.99|21.52||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||21.52|-8.99|0.4173
91561339|NCT02068352|183011284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.47||||0.4895|TWO_SIDED|95.0|-9.43|20.36||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||20.36|-9.43|0.4895
91561340|NCT02068352|183011284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.19||||0.2677|TWO_SIDED|95.0|-6.74|25.12||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.12|-6.74|0.2677
91561341|NCT02068352|183011284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.12||||0.2319|TWO_SIDED|95.0|-5.63|25.87||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.87|-5.63|0.2319
91561342|NCT02068352|183011285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11||||0.3213|TWO_SIDED|95.0|-3.33|1.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.11|-3.33|0.3213
91561343|NCT02068352|183011285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09||||0.0594|TWO_SIDED|95.0|-4.27|0.08|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.08|-4.27|0.0594
91561344|NCT02068352|183011285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03||||0.396|TWO_SIDED|95.0|-3.43|1.37|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.37|-3.43|0.396
91561345|NCT02068352|183011285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.1135|TWO_SIDED|95.0|-4.26|0.46|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.46|-4.26|0.1135
91561346|NCT02068352|183011286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||0.1703|TWO_SIDED|95.0|-3.63|0.65|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.65|-3.63|0.1703
91561347|NCT02068352|183011286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56||||0.0176|TWO_SIDED|95.0|-4.67|-0.45|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.45|-4.67|0.0176
91561348|NCT02068352|183011286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.41||||0.2381|TWO_SIDED|95.0|-3.78|0.95|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.95|-3.78|0.2381
91561349|NCT02068352|183011286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.36||||0.047|TWO_SIDED|95.0|-4.68|-0.03|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.03|-4.68|0.047
91561350|NCT02068352|183011287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.8196|TWO_SIDED|95.0|-13.5|10.7|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||10.7|-13.5|0.8196
91561351|NCT02068352|183011287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.83||||0.0503|TWO_SIDED|95.0|-23.69|0.02|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.02|-23.69|0.0503
91561352|NCT02068352|183011287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68||||0.5902|TWO_SIDED|95.0|-17.22|9.85|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||9.85|-17.22|0.5902
91561353|NCT02068352|183011287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42||||0.0482|TWO_SIDED|95.0|-26.73|-0.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.11|-26.73|0.0482
91561354|NCT02068352|183011288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.8633|TWO_SIDED|95.0|-12.48|10.48|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.48|-12.48|0.8633
91561355|NCT02068352|183011288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.54||||0.0452|TWO_SIDED|95.0|-22.83|-0.25|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.25|-22.83|0.0452
91561356|NCT02068352|183011288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73||||0.6746|TWO_SIDED|95.0|-15.58|10.12|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.12|-15.58|0.6746
91561357|NCT02068352|183011288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.05||||0.0432|TWO_SIDED|95.0|-25.69|-0.4|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.4|-25.69|0.0432
91561358|NCT01767376|183011291|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.48|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination.||1.48|0.97|
91561359|NCT01767376|183011291|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.12|||||TWO_SIDED|95.0|0.85|1.47|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, one month after Nimenrix vaccination.||1.47|0.85|
91768959|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||35.4|-33.8|1.000
91768960|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|5.7||||1|TWO_SIDED|95.0|-33.8|45.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||45.3|-33.8|1.000
91561360|NCT01767376|183011291|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.86|1.32|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, one month after Nimenrix vaccination.||1.32|0.86|
91768961|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-7.6||||0.598|TWO_SIDED|95.0|-29.9|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.6|-29.9|0.598
91561361|NCT01767376|183011291|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.27|||||TWO_SIDED|95.0|1.02|1.59|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, one month after Nimenrix vaccination.||1.59|1.02|
91561362|NCT01767376|183011292|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-2.14|||||TWO_SIDED|95.0|-7.88|3.53||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.||3.53|-7.88|
91561363|NCT01767376|183011292|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-0.44|||||TWO_SIDED|95.0|-2.48|1.26||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.||1.26|-2.48|
91561364|NCT01767376|183011293|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.||0.89|0.66|
91561365|NCT01767376|183011293|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.||0.65|0.50|
91561366|NCT01767376|183011293|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.88|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.||0.88|0.59|
91561367|NCT03557307|183011307|OTHER||percentage|62.9|||||TWO_SIDED|95.0|58.86|66.76|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieved 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||66.76|58.86|
91561368|NCT03557307|183011308|OTHER||percentage|81.9|||||TWO_SIDED|95.0|78.62|84.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma|||84.94|78.62|
91561369|NCT03557307|183011309|OTHER||percentage|91.5|||||TWO_SIDED|95.0|88.94|93.58|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma|||93.58|88.94|
91561370|NCT03557307|183011310|OTHER||percentage|64.0|||||TWO_SIDED|95.0|60.06|67.9|||Clopper-Pearson Exact CI|One sample Confidence Interval (≥90% reduction)|Percentage of patients who achieve \>=90% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||67.90|60.06|
91561371|NCT03557307|183011310|OTHER||percentage|68.9|||||TWO_SIDED|95.0|65.02|72.59|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=75% reduction)|Percentage of patients who achieve \>=75% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||72.59|65.02|
91561372|NCT03557307|183011310|OTHER||percentage|81.8|||||TWO_SIDED|95.0|78.44|84.79|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=50% reduction)|Percentage of patients who achieve \>=50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||84.79|78.44|
91768962|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-30.7|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||24.3|-30.7|1.000
91768963|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|12.9||||0.468|TWO_SIDED|95.0|-24.7|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52|Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|50.4|-24.7|0.468
91561373|NCT03557307|183011311|OTHER||percentage change from baseline|-76.92|||||TWO_SIDED|95.0|-79.9|-73.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage change from baseline in daily OCS dose at the end of OCS reduction phase|||-73.94|-79.90|
91561374|NCT03745651|183011316|SUPERIORITY||Odds Ratio (OR)|8.84|||<|0.0001|TWO_SIDED|95.0|4.125|21.202||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||21.202|4.125|< 0.0001
91561375|NCT03745651|183011316|SUPERIORITY||Odds Ratio (OR)|15.8|||<|0.0001|TWO_SIDED|95.0|7.354|38.061||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||38.061|7.354|< 0.0001
91561376|NCT03745651|183011317|SUPERIORITY||Odds Ratio (OR)|6.84|||<|0.0001|TWO_SIDED|95.0|3.723|13.184||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.184|3.723|< 0.0001
91561377|NCT03745651|183011317|SUPERIORITY||Odds Ratio (OR)|10.67|||<|0.0001|TWO_SIDED|95.0|5.775|20.732||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||20.732|5.775|< 0.0001
91561378|NCT03745651|183011318|SUPERIORITY||Odds Ratio (OR)|4.17|||<|0.0001|TWO_SIDED|95.0|2.045|9.036||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||9.036|2.045|< 0.0001
91561379|NCT03745651|183011318|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.833|12.657||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||12.657|2.833|< 0.0001
91561380|NCT03745651|183011319|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8553|TWO_SIDED|95.0|0.598|2.094||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.094|0.598|0.8553
91561381|NCT03745651|183011319|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2359|TWO_SIDED|95.0|0.805|2.741||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.741|0.805|0.2359
91561382|NCT03745651|183011320|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1784|TWO_SIDED|95.0|0.827|3.342||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.342|0.827|0.1784
91561383|NCT03745651|183011320|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0472|TWO_SIDED|95.0|1.007|4.0||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.000|1.007|0.0472
91561384|NCT03745651|183011330|SUPERIORITY||Least Squares Mean Difference|-31.91|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|-41.57|-22.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-22.25|-41.57|<0.0001
91561385|NCT03745651|183011330|SUPERIORITY||Least Squares Mean Difference|-35.13|STANDARD_ERROR_OF_MEAN|4.93|<|0.0001|TWO_SIDED|95.0|-44.81|-25.44|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-25.44|-44.81|<0.0001
91561386|NCT03745651|183011330|SUPERIORITY||Least Squares Mean Difference|-44.56|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-53.19|-35.92|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.92|-53.19|<0.0001
91561387|NCT03745651|183011330|SUPERIORITY||Least Squares Mean Difference|-45.91|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-54.55|-37.26|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-37.26|-54.55|<0.0001
91561388|NCT03745651|183011330|SUPERIORITY||Least Squares Mean Difference|-44.53|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-53.08|-35.98|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-35.98|-53.08|<0.0001
91561389|NCT03745651|183011330|SUPERIORITY||Least Squares Mean Difference|-46.0|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-54.51|-37.48|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-37.48|-54.51|<0.0001
91561390|NCT03745651|183011331|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-46.48|-32.38|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-32.38|-46.48|<0.0001
91561391|NCT03745651|183011331|SUPERIORITY||Least Squares Mean Difference|-43.5|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-50.51|-36.53|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-36.53|-50.51|<0.0001
91768964|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|6.2||||1|TWO_SIDED|95.0|-15.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||28.1|-15.7|1.000
91561392|NCT03745651|183011332|SUPERIORITY||Least Squares Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.02|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.01|-2.02|<0.0001
91561393|NCT03745651|183011332|SUPERIORITY||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.24|-1.24|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.24|-2.24|<0.0001
91561394|NCT03745651|183011332|SUPERIORITY||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.36|-1.23|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.23|-2.36|<0.0001
91561395|NCT03745651|183011332|SUPERIORITY||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.53|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.40|-2.53|<0.0001
91561396|NCT03745651|183011332|SUPERIORITY||Least Squares Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.49|-1.29|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.29|-2.49|<0.0001
91768965|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|15.1||||0.538|TWO_SIDED|95.0|-15.2|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.4|-15.2|0.538
91768966|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-11.2||||0.692|TWO_SIDED|95.0|-48.0|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||25.6|-48.0|0.692
91768967|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-46.9|0.388
91561397|NCT03745651|183011332|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.10|-2.30|<0.0001
91561398|NCT03745651|183011334|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.94|-0.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.97|-1.94|<0.0001
91768968|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-19.0||||0.418|TWO_SIDED|95.0|-54.8|16.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||16.9|-54.8|0.418
91768969|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-17.1||||0.448|TWO_SIDED|95.0|-54.1|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-54.1|0.448
91768970|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-13.7||||0.43|TWO_SIDED|95.0|-47.4|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.9|-47.4|0.430
91561399|NCT03745651|183011334|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.72|-0.76|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.76|-1.72|<0.0001
91561400|NCT03745651|183011337|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2903|TWO_SIDED|95.0|-1.71|0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.51|-1.71|0.2903
91768971|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-42.8|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||37.6|-42.8|1.000
91768972|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-21.2||||0.406|TWO_SIDED|95.0|-55.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||12.9|-55.3|0.406
91768973|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.9|0.388
91768974|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-7.8||||1|TWO_SIDED|95.0|-46.5|30.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||30.8|-46.5|1.000
91768975|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-25.3||||0.204|TWO_SIDED|95.0|-54.7|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||4.1|-54.7|0.204
91768976|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-2.0||||0.907|TWO_SIDED|95.0|-34.9|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-34.9|0.907
91768977|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-40.2|36.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||36.3|-40.2|1.000
91768978|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|6.5||||1|TWO_SIDED|95.0|-28.4|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||41.3|-28.4|1.000
91768979|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|16.5||||0.45|TWO_SIDED|95.0|-15.5|48.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.4|-15.5|0.450
91768980|NCT02365649|183425727|SUPERIORITY||Risk Difference (RD)|9.8||||0.661|TWO_SIDED|95.0|-27.0|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.6|-27.0|0.661
91768981|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
91768982|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||70.8|-20.8|0.608
91768983|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
91561401|NCT03745651|183011337|SUPERIORITY||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.57||0.0837|TWO_SIDED|95.0|-2.09|0.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.13|-2.09|0.0837
91768984|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||77.5|-77.5|1.000
91768985|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||49.0|-49.0|1.000
91768986|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-30.0||||0.565|TWO_SIDED|95.0|-79.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||19.3|-79.3|0.565
91561402|NCT03745651|183011337|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6272|TWO_SIDED|95.0|-1.5|0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.91|-1.50|0.6272
91561403|NCT03745651|183011337|SUPERIORITY||Least Squares Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.61||0.1609|TWO_SIDED|95.0|-2.07|0.34|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.34|-2.07|0.1609
91561404|NCT03745651|183011337|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.73||0.3362|TWO_SIDED|95.0|-2.13|0.73|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.73|-2.13|0.3362
91561405|NCT03745651|183011337|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.269|TWO_SIDED|95.0|-2.23|0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.62|-2.23|0.2690
91561406|NCT03745651|183011338|SUPERIORITY||Least Squares Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0482|TWO_SIDED|95.0|-2.13|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.13|0.0482
91561407|NCT03745651|183011338|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54||0.0271|TWO_SIDED|95.0|-2.26|-0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.14|-2.26|0.0271
91561408|NCT03745651|183011338|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.6||0.2091|TWO_SIDED|95.0|-1.94|0.42|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||0.42|-1.94|0.2091
91561409|NCT03745651|183011338|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.6||0.0111|TWO_SIDED|95.0|-2.71|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.71|0.0111
91561410|NCT03745651|183011338|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.68||0.0802|TWO_SIDED|95.0|-2.51|0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.14|-2.51|0.0802
91561411|NCT03745651|183011338|SUPERIORITY||Least Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.67||0.0666|TWO_SIDED|95.0|-2.56|0.09|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.09|-2.56|0.0666
91561412|NCT03745651|183011341|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.84|-2.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.97|-4.84|<0.0001
91768987|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||84.6|15.4|0.467
91561413|NCT03745651|183011341|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-5.47|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-3.63|-5.47|<0.0001
91561414|NCT03745651|183011343|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.38|-4.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.86|-7.38|<0.0001
91561415|NCT03745651|183011343|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.17|-4.67|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.67|-7.17|<0.0001
91768988|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||49.0|-49.0|1.000
91768989|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-15.4|-84.6|0.105
91768990|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||89.5|-64.5|1.000
91561416|NCT03745651|183011345|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.19|-2.32|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.32|-4.19|<0.0001
91561417|NCT03745651|183011345|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.67|-1.83|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-1.83|-3.67|<0.0001
91561418|NCT03745651|183011347|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.55||0.0099|TWO_SIDED|95.0|-7.24|-1.03|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.03|-7.24|0.0099
91561419|NCT03745651|183011347|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.59||0.0542|TWO_SIDED|95.0|-6.3|0.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||0.06|-6.30|0.0542
91768991|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.7|-35.7|1.000
91768992|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
91768993|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||84.6|15.4|0.467
91768994|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||60.7|-35.7|1.000
91561420|NCT03745651|183011351|SUPERIORITY||Odds Ratio (OR)|5.16|||<|0.0001|TWO_SIDED|95.0|2.987|9.049||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||9.049|2.987|<0.0001
91768995|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||-15.4|-84.6|0.105
91768996|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
91768997|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||18.2|-28.2|1.000
91768998|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
91561421|NCT03745651|183011351|SUPERIORITY||Odds Ratio (OR)|7.47|||<|0.0001|TWO_SIDED|95.0|4.23|13.415||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||13.415|4.230|<0.0001
91768999|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
91769000|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
91561422|NCT03745651|183011352|SUPERIORITY||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|1.78||0.015|TWO_SIDED|95.0|0.85|7.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||7.86|0.85|0.0150
91561423|NCT03745651|183011352|SUPERIORITY||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|1.77||0.0044|TWO_SIDED|95.0|1.59|8.54|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.54|1.59|0.0044
91561424|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.81||0.142|TWO_SIDED|95.0|-13.12|1.89|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.89|-13.12|0.1420
91561425|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.82||0.0375|TWO_SIDED|95.0|-15.51|-0.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-0.47|-15.51|0.0375
91561426|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.75||0.0012|TWO_SIDED|95.0|-14.48|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-3.63|-14.48|0.0012
91561427|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.74||0.0095|TWO_SIDED|95.0|-12.58|-1.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-1.77|-12.58|0.0095
91561428|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-22.69|-7.73|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.73|-22.69|<0.0001
91561429|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|3.79||0.001|TWO_SIDED|95.0|-20.1|-5.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.18|-20.10|0.0010
91561430|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-16.18|-7.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.95|-16.18|<0.0001
91561431|NCT03745651|183011353|SUPERIORITY||Least Squares Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.53|-6.37|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.37|-14.53|<0.0001
91769001|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
91769002|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||72.9|-19.6|0.249
91561432|NCT01322347|183011375|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.39||0.011|TWO_SIDED|95.0||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
91561433|NCT04883541|183011394|SUPERIORITY|the t-test in independent groups|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.8|<|0.05|TWO_SIDED|0.05|||||t-test, 2 sided|||||||<0.05
91561434|NCT04239911|183011405|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|0.97||||0.974|TWO_SIDED|95.0|0.14|6.85|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of leaving their current job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||6.85|0.14|0.974
91769003|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||18.2|-28.2|1.000
91769004|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||24.6|-29.0|1.000
91769005|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|13.3||||0.613|TWO_SIDED|95.0|-35.1|61.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||61.8|-35.1|0.613
91769006|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-34.8|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||31.5|-34.8|1.000
91769007|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-15.6||||0.615|TWO_SIDED|95.0|-45.9|14.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.8|-45.9|0.615
91561435|NCT04239911|183011405|EQUIVALENCE|A p\< 0.05 considered the threshold for statistical significance|Odds Ratio (OR)|0.8||||0.846|TWO_SIDED|95.0|0.08|7.72|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of searching for a new job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||7.72|0.08|0.846
91561436|NCT04239911|183011408|EQUIVALENCE|A p\<0.05 was considered the threshold for statistical significance.|Odds Ratio (OR)|0.18||||0.043|TWO_SIDED|95.0|0.03|0.94|||Regression, Logistic||The comparison group is enhanced usual care arm|"Preventable 911 calls if had been able to reach the doctor. Dichotomized into agree, strongly agree, and very strongly vs. all other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||0.94|0.03|0.043
91561437|NCT04239911|183011408|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.22|4.58|||Regression, Logistic|||"Preventable 911 calls if had been able to reach the nurse/supervisor. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||4.58|0.22|0.99
91561438|NCT02137785|183011409|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.||||0.0001
91561439|NCT02137785|183011410|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
91561440|NCT02137785|183011411|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
91561441|NCT02137785|183011412|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||||||0.0001
91769008|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||67.5|-27.5|0.560
91769009|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-26.8|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52||36.8|-26.8|1.000
91561442|NCT03345407|183011472|OTHER||Posterior adjusted median difference|-0.022|||||TWO_SIDED|95.0|-0.143|0.103|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.103|-0.143|
91769010|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.9|-37.7|1.000
91769011|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
91561443|NCT03345407|183011472|OTHER||Posterior adjusted median difference|-0.027|||||TWO_SIDED|95.0|-0.098|0.036|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.036|-0.098|
91561444|NCT03345407|183011472|OTHER||Posterior adjusted median difference|-0.038|||||TWO_SIDED|95.0|-0.102|0.028|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.028|-0.102|
91769012|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.1|-26.1|0.588
91561445|NCT03345407|183011472|OTHER||Posterior adjusted median difference|0.005|||||TWO_SIDED|95.0|-0.064|0.071|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.071|-0.064|
91561446|NCT03345407|183011472|OTHER||Posterior adjusted median difference|-0.003|||||TWO_SIDED|95.0|-0.075|0.061|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.061|-0.075|
91561447|NCT03345407|183011472|OTHER||Posterior adjusted median difference|-0.004|||||TWO_SIDED|95.0|-0.051|0.042|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.042|-0.051|
91561448|NCT03345407|183011473|OTHER||Posterior median exacerbation rate ratio|0.92|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.|||1.40|0.60|
91769013|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
91769014|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|16.7||||0.631|TWO_SIDED|95.0|-29.9|63.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||63.2|-29.9|0.631
91769015|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|9.5||||0.597|TWO_SIDED|95.0|-25.7|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||44.8|-25.7|0.597
91769016|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-46.7|30.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||30.0|-46.7|1.000
91561449|NCT03345407|183011473|OTHER||Posterior median exacerbation rate ratio|0.89|||||TWO_SIDED|95.0|0.57|1.35|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.|||1.35|0.57|
91561450|NCT03345407|183011473|OTHER||Posterior median exacerbation rate ratio|1.01|||||TWO_SIDED|95.0|0.65|1.5|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.|||1.50|0.65|
91561451|NCT03345407|183011473|OTHER||Posterior median exacerbation rate ratio|0.63|||||TWO_SIDED|95.0|0.37|1.02|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.|||1.02|0.37|
91561452|NCT03345407|183011473|OTHER||Posterior median exacerbation rate ratio|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.|||1.52|0.85|
91561453|NCT03345407|183011474|OTHER||Posterior median hazard ratio|0.455|||||TWO_SIDED|95.0|0.054|1.103|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.103|0.054|
91561454|NCT03345407|183011474|OTHER||Posterior median hazard ratio|0.991|||||TWO_SIDED|95.0|0.58|1.5|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.500|0.580|
91561455|NCT03345407|183011474|OTHER||Posterior median hazard ratio|0.975|||||TWO_SIDED|95.0|0.581|1.467|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.467|0.581|
91561456|NCT03345407|183011474|OTHER||Posterior median hazard ratio|1.132|||||TWO_SIDED|95.0|0.682|1.709|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.709|0.682|
91561457|NCT03345407|183011474|OTHER||Posterior median hazard ratio|0.556|||||TWO_SIDED|95.0|0.268|0.902|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||0.902|0.268|
91561458|NCT03345407|183011474|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.8|1.539|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.539|0.800|
91561459|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.01|||||TWO_SIDED|95.0|0.21|2.3|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.30|0.21|
91561460|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.76|2.17|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.76|
91561461|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.99|||||TWO_SIDED|95.0|0.54|1.61|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.61|0.54|
91561462|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.5|1.49|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.50|
91561463|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.75|||||TWO_SIDED|95.0|0.38|1.25|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.25|0.38|
91561464|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.77|1.63|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.63|0.77|
91561465|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.21|||||TWO_SIDED|95.0|0.36|2.69|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.69|0.36|
91561466|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.82|2.33|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.33|0.82|
91561467|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.67|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.67|
91561468|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.74|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.74|0.63|
91561469|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.55|||||TWO_SIDED|95.0|0.28|0.88|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.88|0.28|
91561470|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.72|1.49|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.72|
91561471|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.0|||||TWO_SIDED|95.0|0.3|2.17|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.30|
91561472|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.46|||||TWO_SIDED|95.0|0.84|2.27|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.84|
91561473|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.15|||||TWO_SIDED|95.0|0.65|1.78|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.78|0.65|
91561474|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.09|||||TWO_SIDED|95.0|0.62|1.67|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.67|0.62|
91561475|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.49|||||TWO_SIDED|95.0|0.26|0.77|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.77|0.26|
91561476|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.71|1.42|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.42|0.71|
91561477|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.32|2.38|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.38|0.32|
91561478|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.7|2.0|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.70|
91561479|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.71|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.71|0.63|
91561480|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.55|1.48|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.55|
91561481|NCT03345407|183011477|OTHER||Posterior median odds ratio|0.56|||||TWO_SIDED|95.0|0.31|0.87|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.87|0.31|
91561482|NCT03345407|183011477|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.73|1.47|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.73|
91561483|NCT03345407|183011478|OTHER||Posterior median hazard ratio|1.053|||||TWO_SIDED|95.0|0.477|1.765|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.765|0.477|
91561484|NCT03345407|183011478|OTHER||Posterior median hazard ratio|1.2|||||TWO_SIDED|95.0|0.84|1.597|||||Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.597|0.840|
91769017|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|26.7||||0.361|TWO_SIDED|95.0|-18.5|71.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||71.8|-18.5|0.361
91769018|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.0|-39.6|0.812
91769019|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-27.5||||0.345|TWO_SIDED|95.0|-61.3|6.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||6.3|-61.3|0.345
91769020|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||57.1|-37.1|1.000
91769021|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.1|-26.1|0.588
91561485|NCT03345407|183011478|OTHER||Posterior median hazard ratio|1.06|||||TWO_SIDED|95.0|0.734|1.432|||||Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.432|0.734|
91769022|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
91769023|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|20.0||||0.635|TWO_SIDED|95.0|-25.4|65.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||65.4|-25.4|0.635
91561486|NCT03345407|183011478|OTHER||Posterior median hazard ratio|1.03|||||TWO_SIDED|95.0|0.719|1.413|||||Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.413|0.719|
91561487|NCT03345407|183011478|OTHER||Posterior median hazard ratio|0.751|||||TWO_SIDED|95.0|0.487|1.057|||||Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.057|0.487|
91561488|NCT03345407|183011478|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.899|1.426|||||Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.426|0.899|
91769024|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|10.5||||0.573|TWO_SIDED|95.0|-25.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.7|-25.7|0.573
91561489|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.22|||||TWO_SIDED|95.0|0.35|2.7|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.70|0.35|
91561490|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.63|1.77|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.77|0.63|
91561491|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.41|||||TWO_SIDED|95.0|0.77|2.17|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.77|
91561492|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.28|||||TWO_SIDED|95.0|0.71|2.0|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.71|
91561493|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.61|1.75|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.75|0.61|
91561494|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.7|||||TWO_SIDED|95.0|0.46|0.99|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.99|0.46|
91561495|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.64|||||TWO_SIDED|95.0|0.2|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.20|
91561496|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.84|2.46|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.46|0.84|
91561497|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.53|1.48|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.53|
91561498|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.36|||||TWO_SIDED|95.0|0.74|2.16|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.16|0.74|
91561499|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.76|||||TWO_SIDED|95.0|0.43|1.17|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.43|
91561500|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.93|||||TWO_SIDED|95.0|0.63|1.27|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.27|0.63|
91561501|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.16|1.2|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.20|0.16|
91561502|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.79|2.56|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.56|0.79|
91561503|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.83|||||TWO_SIDED|95.0|0.46|1.3|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.30|0.46|
91561504|NCT03345407|183011480|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.62|1.86|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.86|0.62|
91561505|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.65|||||TWO_SIDED|95.0|0.36|1.02|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.02|0.36|
91561506|NCT03345407|183011480|OTHER||Posterior median odds ratio|0.85|||||TWO_SIDED|95.0|0.57|1.17|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.57|
91561507|NCT03345407|183011481|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-0.5|5.2|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.2|-0.5|
91561508|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.7|||||TWO_SIDED|95.0|-0.8|2.3|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-0.8|
91561509|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.8|2.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.8|
91561510|NCT03345407|183011481|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-2.0|1.2|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.2|-2.0|
91561511|NCT03345407|183011481|OTHER||Posterior adjacent median difference|1.6|||||TWO_SIDED|95.0|0.0|3.3|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.3|0.0|
91561512|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-1.1|
91561513|NCT03345407|183011481|OTHER||Posterior adjusted median difference|2.3|||||TWO_SIDED|95.0|-0.5|5.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.4|-0.5|
91561514|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.4|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.9|
91561515|NCT03345407|183011481|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-1.9|1.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.4|-1.9|
91561516|NCT03345407|183011481|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.0|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-2.3|
91561517|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-1.2|2.2|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.2|-1.2|
91561518|NCT03345407|183011481|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-1.4|
91561519|NCT03345407|183011481|OTHER||Posterior adjusted median difference|1.9|||||TWO_SIDED|95.0|-1.4|5.1|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.1|-1.4|
91561520|NCT03345407|183011481|OTHER||Posterior adjusted median difference|1.1|||||TWO_SIDED|95.0|-0.7|2.8|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.7|
91561521|NCT03345407|183011481|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.|||1.1|-2.3|
91561522|NCT03345407|183011481|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-1.9|1.7|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-1.9|
91561523|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.9|
91561524|NCT03345407|183011481|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-0.8|1.7|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-0.8|
91561525|NCT03345407|183011482|OTHER||Posterior median odds ratio|0.51|||||TWO_SIDED|95.0|0.03|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.03|
91561526|NCT03345407|183011482|OTHER||Posterior median odds ratio|0.87|||||TWO_SIDED|95.0|0.42|1.47|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.42|
91561527|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.69|2.24|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.24|0.69|
91561528|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.78|||||TWO_SIDED|95.0|0.95|2.91|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.91|0.95|
91769025|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-34.2||||0.176|TWO_SIDED|95.0|-68.3|-0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||-0.1|-68.3|0.176
91561529|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.24|||||TWO_SIDED|95.0|0.61|2.08|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.08|0.61|
91561530|NCT03345407|183011482|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.40|0.60|
91561531|NCT03345407|183011482|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.14|1.16|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.16|0.14|
91561532|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.74|1.98|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.98|0.74|
91561533|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.73|1.97|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.97|0.73|
91561534|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.47|||||TWO_SIDED|95.0|0.83|2.27|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.83|
91561535|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.57|1.62|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.62|0.57|
91561536|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.1|||||TWO_SIDED|95.0|0.75|1.5|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.50|0.75|
91561537|NCT03345407|183011482|OTHER||Posterior median odds ratio|0.63|||||TWO_SIDED|95.0|0.17|1.39|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.39|0.17|
91561538|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.72|2.01|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.01|0.72|
91561539|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.13|||||TWO_SIDED|95.0|0.64|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.64|
91769026|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
91561540|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.35|||||TWO_SIDED|95.0|0.75|2.14|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.14|0.75|
91561541|NCT03345407|183011482|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.53|1.45|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.45|0.53|
91561542|NCT03345407|183011482|OTHER||Posterior median odds ratio|1.03|||||TWO_SIDED|95.0|0.71|1.43|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.43|0.71|
91561543|NCT03345407|183011483|OTHER||Posterior adjusted median difference|2.0|||||TWO_SIDED|95.0|-4.8|8.3|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||8.3|-4.8|
91561544|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-4.0|3.1|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.1|-4.0|
91561545|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-2.9|||||TWO_SIDED|95.0|-6.2|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.2|
91561546|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-3.2|||||TWO_SIDED|95.0|-6.7|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-6.7|
91561547|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-4.0|3.5|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.5|-4.0|
91561548|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-2.7|2.3|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-2.7|
91561549|NCT03345407|183011483|OTHER||Posterior adjusted median difference|4.1|||||TWO_SIDED|95.0|-2.5|11.0|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||11.0|-2.5|
91561550|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-1.2|||||TWO_SIDED|95.0|-4.8|2.5|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-4.8|
91561551|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-2.7|||||TWO_SIDED|95.0|-6.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.3|
91561552|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-3.3|||||TWO_SIDED|95.0|-7.3|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-7.3|
91561553|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.0|-4.6|
91769027|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
91561554|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.4|||||TWO_SIDED|95.0|-2.9|2.5|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-2.9|
91561555|NCT03345407|183011483|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-4.8|9.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||9.4|-4.8|
91561556|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-4.1|3.6|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.6|-4.1|
91769028|NCT02365649|183425728|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
91769029|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|1.000
91561557|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-2.3|||||TWO_SIDED|95.0|-6.1|1.8|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.8|-6.1|
91561558|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.3|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-5.7|
91561559|NCT03345407|183011483|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-4.5|3.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.8|-4.5|
91561560|NCT03345407|183011483|OTHER||Posterior adjusted median difference|1.2|||||TWO_SIDED|95.0|-1.7|4.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||4.0|-1.7|
91561561|NCT01584648|183011498|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.59|0.91|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||0.91|0.59|
91561562|NCT01584648|183011499|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||1.02|0.64|
91561563|NCT00065611|183011506|SUPERIORITY_OR_OTHER|||||||0.9074||95.0|||||Chi-squared|||||||0.9074
91561564|NCT00065611|183011507|SUPERIORITY_OR_OTHER|||||||0.4566||95.0|||||ANOVA|||||||0.4566
91561565|NCT00065611|183011508|SUPERIORITY_OR_OTHER|||||||0.3792||95.0|||||ANOVA|||||||0.3792
91561566|NCT03693989|183011509|OTHER|||||||0.065|||||||t-test, 2 sided|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.065
91561567|NCT03693989|183011510|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.223|||||||t-test, 2 sided|||||||0.223
91561568|NCT03693989|183011511|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.621|||||||Chi-squared, Corrected|||||||0.621
91561569|NCT03693989|183011512|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.246|||||||Fisher Exact|||||||0.246
91561570|NCT03693989|183011513|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||||||0.497
91561571|NCT03693989|183011514|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.047|||||||t-test, 2 sided|||||||0.047
91561572|NCT03693989|183011515|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.3|||||||Chi-squared, Corrected|||||||0.300
91561573|NCT03693989|183011516|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.045|||||||t-test, 2 sided|||||||0.045
91561574|NCT03693989|183011517|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.346|||||||Fisher Exact|||burning eyes comparison||||0.346
91561575|NCT03693989|183011517|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.489|||||||Fisher Exact|||Itching eyes comparison||||0.489
91561576|NCT03693989|183011517|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||foreign body sensation eyes comparison||||0.497
91769030|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-32.5|57.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||57.5|-32.5|1.000
91769031|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|0.487
91769032|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ|Non-respoonders||31.6|-9.4|0.375
91561577|NCT03693989|183011517|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||1|||||||Fisher Exact|||blurred vision comparison||||1.000
91769033|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||3.9|-30.5|1.000
91561578|NCT03403153|183011554|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
91561579|NCT03403153|183011555|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
91561580|NCT03403153|183011556|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
91561581|NCT03403153|183011557|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
91561582|NCT03403153|183011558|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
91561583|NCT03403153|183011559|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
91561584|NCT03403153|183011560|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
91561585|NCT00113529|183011563|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|37.1||||||95.0|21.5|55.1|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||55.1|21.5|
91561586|NCT00113529|183011569|SUPERIORITY_OR_OTHER||probability|82.4||||||95.0|64.9|91.7||||||||91.7|64.9|
91561587|NCT00113529|183011578|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.075
91561588|NCT00113529|183011578|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.749
91561589|NCT00113529|183011578|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.834
91561590|NCT00113529|183011578|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
91561591|NCT00113529|183011578|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.332
91561592|NCT00113529|183011579|SUPERIORITY_OR_OTHER|||||||0.473||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.473
91561593|NCT00113529|183011579|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.286
91561594|NCT00113529|183011579|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.277
91561595|NCT00113529|183011579|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.956
91561596|NCT00113529|183011579|SUPERIORITY_OR_OTHER|||||||0.278||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.278
91561597|NCT00113529|183011580|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.275
91561598|NCT00113529|183011580|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.227
91561599|NCT00113529|183011580|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.029
91561600|NCT00113529|183011580|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
91561601|NCT00113529|183011580|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||1.000
91561602|NCT00113529|183011581|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.435
91561603|NCT00113529|183011581|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.722
91561604|NCT00113529|183011581|SUPERIORITY_OR_OTHER|||||||0.645||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.645
91561605|NCT00113529|183011581|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.140
91561606|NCT00113529|183011581|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.046
91561607|NCT00113529|183011582|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
91561608|NCT00113529|183011582|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
91561609|NCT00113529|183011582|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
91769034|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|8.1||||0.651|TWO_SIDED|95.0|-19.4|35.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.6|-19.4|0.651
91769035|NCT02365649|183425729|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||27.8|-29.5|1.000
91769036|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
91561610|NCT00113529|183011582|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
91561611|NCT00113529|183011582|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
91561612|NCT00113529|183011582|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
91561613|NCT00113529|183011583|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
91561614|NCT00113529|183011583|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
91561615|NCT00113529|183011583|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
91561616|NCT00113529|183011583|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
91561617|NCT00113529|183011583|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
91561618|NCT00113529|183011583|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
91561619|NCT00113529|183011584|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
91561620|NCT00113529|183011584|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
91561621|NCT00113529|183011584|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
91561622|NCT00113529|183011584|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
91561623|NCT00113529|183011584|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
91561624|NCT00113529|183011584|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
91561625|NCT00113529|183011585|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
91561626|NCT00113529|183011585|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
91561627|NCT00113529|183011585|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
91561628|NCT00113529|183011585|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
91561629|NCT00113529|183011585|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
91561630|NCT00113529|183011585|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
91561631|NCT00113529|183011586|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
91561632|NCT00113529|183011586|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
91561633|NCT00113529|183011586|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
91561634|NCT00113529|183011586|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
91561635|NCT00113529|183011586|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
91561636|NCT00113529|183011586|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
91561637|NCT00113529|183011587|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
91561638|NCT00113529|183011587|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
91769037|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||49.0|-49.0|1.000
91769038|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
91769039|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||89.5|-64.5|1.000
91769040|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||60.7|-35.7|1.000
91769041|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||31.0|-66.0|1.000
91769042|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|62.5||||0.444|TWO_SIDED|95.0|29.0|96.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||96.0|29.0|0.444
91769043|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||72.4|-22.4|0.619
91769044|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-37.5||||0.231|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-4.0|-71.0|0.231
91769045|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-37.5||||1|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-4.0|-71.0|1.000
91769046|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||72.4|-22.4|0.619
91561639|NCT00113529|183011587|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
91561640|NCT00113529|183011587|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
91561641|NCT00113529|183011587|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
91769047|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
91769048|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|75.0||||0.133|TWO_SIDED|95.0|45.0|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||100.0|45.0|0.133
91769049|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|37.5||||0.315|TWO_SIDED|95.0|-7.5|82.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||82.5|-7.5|0.315
91561642|NCT00113529|183011587|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
91561643|NCT00113529|183011588|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
91561644|NCT00113529|183011588|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
91561645|NCT00113529|183011588|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
91561646|NCT00113529|183011588|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
91561647|NCT00113529|183011588|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
91561648|NCT00113529|183011588|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
91561649|NCT00113529|183011589|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
91561650|NCT00113529|183011589|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
91561651|NCT00113529|183011589|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
91561652|NCT00113529|183011589|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
91561653|NCT00113529|183011589|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
91561654|NCT00113529|183011589|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
91561655|NCT04421456|183011614|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.75|STANDARD_ERROR_OF_MEAN|2.33||0.4528|TWO_SIDED|95.0|-6.35|2.84|||Mixed-effects repeated measures model|||||2.84|-6.35|0.4528
91561656|NCT04421456|183011614|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.96|STANDARD_ERROR_OF_MEAN|2.44||0.4226|TWO_SIDED|95.0|-6.76|2.85|||Mixed-effects repeated measures model|||||2.85|-6.76|0.4226
91561657|NCT04421456|183011615|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.83||0.4479|TWO_SIDED|95.0|-2.25|1.0|||Mixed-effects repeated measures model|||||1.00|-2.25|0.4479
91561658|NCT04421456|183011615|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.87||0.1616|TWO_SIDED|95.0|-2.92|0.49|||Mixed-effects repeated measures model|||||0.49|-2.92|0.1616
91561659|NCT04421456|183011616|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.76||0.6787|TWO_SIDED|95.0|-1.8|1.18|||Mixed-effects repeated measures model|||||1.18|-1.80|0.6787
91561660|NCT04421456|183011616|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.78||0.3351|TWO_SIDED|95.0|-0.79|2.3|||Mixed-effects repeated measures model|||||2.30|-0.79|0.3351
91561661|NCT04421456|183011617|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.45||0.4504|TWO_SIDED|95.0|-3.96|1.76|||Mixed-effects repeated measures model|||||1.76|-3.96|0.4504
91561662|NCT04421456|183011617|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.52||0.4195|TWO_SIDED|95.0|-4.22|1.76|||Mixed-effects repeated measures model|||||1.76|-4.22|0.4195
91769050|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||5.0|-55.0|0.487
91561663|NCT04421456|183011618|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.885|TWO_SIDED|95.0|-0.35|0.3|||Mixed-effects repeated measures model|||||0.30|-0.35|0.8850
91561664|NCT04421456|183011618|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.7808|TWO_SIDED|95.0|-0.36|0.27|||Mixed-effects repeated measures model|||||0.27|-0.36|0.7808
91561665|NCT04421456|183011619|SUPERIORITY||Odds Ratio (OR)|1.412||||0.6707|TWO_SIDED|95.0|0.288|6.924|||Regression, Logistic|||||6.924|0.288|0.6707
91561666|NCT04421456|183011619|SUPERIORITY||Odds Ratio (OR)|0.576||||0.4883|TWO_SIDED|95.0|0.121|2.744|||Regression, Logistic|||||2.744|0.121|0.4883
91561667|NCT00379210|183011630|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha level||||<0.01
91561668|NCT00595959|183011631|SUPERIORITY_OR_OTHER|||||||0.001||||||No adjustments|t-test, 1 sided|||Comparing to an expected value of 20% reduction from initial to post-laser||||0.001
91561669|NCT00886834|183011643|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
91561670|NCT01297595|183011652|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.58|||||TWO_SIDED|90.0|91.08|108.87||||||Natural log transformed AUC (0 - ∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||108.87|91.08|
91561671|NCT01297595|183011654|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.35|||||TWO_SIDED|90.0|90.51|109.07||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||109.07|90.51|
91561672|NCT01297595|183011655|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|96.84|||||TWO_SIDED|90.0|88.22|106.32||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||106.32|88.22|
91561673|NCT01697956|183011670|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of BDP nasal aerosol versus placebo was greater than 0.80.|ratio of BDP nasal aerosol to placebo|0.91|||||TWO_SIDED|95.0|0.81|1.03||||||The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups.||1.03|0.81|
91561674|NCT03060525|183011680|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|1.51||0.026|TWO_SIDED|95.0|-6.32|-0.41|||Mixed Models Analysis|||Difference in weight change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.41|-6.32|0.026
91561675|NCT03060525|183011681|SUPERIORITY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.59||0.03|TWO_SIDED|95.0|-2.42|-0.12|||Mixed Models Analysis|||Difference in Body Mass Index (BMI) change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.12|-2.42|0.03
91561676|NCT03060525|183011682|SUPERIORITY||Median Difference (Net)|247.5||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||||0.63
91561677|NCT01964547|183011683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.|Estimated mean treatment difference|-1.47|STANDARD_ERROR_OF_MEAN|2.492|||ONE_SIDED|97.5|-6.41||||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).|||-6.41|
91561678|NCT01964547|183011684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.|Estimated mean treatment difference|-0.29|STANDARD_ERROR_OF_MEAN|1.323|||ONE_SIDED|97.5||2.33|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||2.33||
91769051|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
91561679|NCT01964547|183011685|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.02||||0.0001|TWO_SIDED|95.0|1.96|8.22|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||8.22|1.96|0.0001
91561680|NCT01964547|183011686|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.0142|TWO_SIDED|95.0|1.23|6.31|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.31|1.23|0.0142
91561681|NCT01964547|183011687|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.0019|TWO_SIDED|95.0|1.51|6.21|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.21|1.51|0.0019
91769052|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-13.3||||0.487|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.487
91561682|NCT01964547|183011688|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.36|STANDARD_ERROR_OF_MEAN|1.88||0.212|TWO_SIDED|95.0|-6.09|1.37|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||1.37|-6.09|0.212
91561683|NCT01964547|183011691|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.88|STANDARD_ERROR_OF_MEAN|8.25||0.556|TWO_SIDED|95.0|-11.51|21.27|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.||21.27|-11.51|0.556
91561684|NCT01964547|183011691|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann median difference|-1.0||||0.088|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon (Mann-Whitney)|||The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.||0|-3|0.088
91561685|NCT01115309|183011694|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
91561686|NCT01115309|183011695|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
91561687|NCT04447287|183011714|OTHER||Geometric LS Mean Ratio|89.72|||||TWO_SIDED|90.0|81.21|99.11||||||||99.11|81.21|
91561688|NCT04447287|183011715|OTHER||Geometric LS Mean Ratio|92.15|||||TWO_SIDED|90.0|80.22|105.86||||||||105.86|80.22|
91561689|NCT04447287|183011716|OTHER||Geometric LS Mean Ratio|109.09|||||TWO_SIDED|90.0|101.1|117.71||||||||117.71|101.10|
91561690|NCT04447287|183011717|OTHER||Geometric LS Mean Ratio|117.77|||||TWO_SIDED|90.0|106.41|130.34||||||||130.34|106.41|
91561691|NCT04447287|183011718|OTHER||Geometric LS Mean Ratio|79.39|||||TWO_SIDED|90.0|68.1|92.55||||||||92.55|68.10|
91561692|NCT04447287|183011719|OTHER||Geometric LS Mean Ratio|74.45|||||TWO_SIDED|90.0|59.28|93.5||||||||93.50|59.28|
91561693|NCT03246724|183011729|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. A 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||As a sensitivity analysis, an ANCOVA model will be fit to the data adjusting for factors that are out of balance following randomization. The mean difference between the adjusted means will be calculated.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Testable hypothesis: Patient satisfaction mean will be non-inferior when given oral triazolam in comparison to IV midazolam during all basic cataracts, retina, cornea, and glaucoma ocular procedures.~Null hypothesis: The null hypothesis is that the oral sedation group will have a primary endpoint mean equal to or less than that of the IV sedation group by the non-inferiority margin or more."||||<0.05
91561694|NCT03246724|183011730|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Surgeon satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean surgeon satisfaction score for oral triazolam will be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: Mean surgeon satisfaction score for oral triazolam will not be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
91561695|NCT03246724|183011731|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Anesthesiologist/CRNA satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean anesthesiologist/CRNA satisfaction score for oral triazolam will be statistically significant in comparison to mean anesthesiologist/CRNA satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:Mean anesthesiologist/CRNA satisfaction score for oral triazolam will not be statistically significant in comparison to mean satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures."||||<0.05
91769053|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
91769054|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
91561696|NCT03246724|183011732|OTHER|Additional anesthesia intervention will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis:The total additional anesthesia interventions for oral triazolam will be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:The total additional anesthesia interventions for oral triazolam will not be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures"||||<0.05
91561697|NCT03246724|183011733|OTHER|Surgical complications will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: The total surgical complications for oral triazolam will be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: The total surgical complications for oral triazolam will not be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
91561698|NCT02978716|183011765|SUPERIORITY||Mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.7048|TWO_SIDED|95.0|-0.8|1.5||A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level.|Analysis of covariance (ANCOVA)|||Duration of SN in Cycle 1 in Group 3 vs Group 1.||1.5|-0.8|0.7048
91561699|NCT02978716|183011765|SUPERIORITY||Mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.71||0.3364|TWO_SIDED|95.0|-0.6|2.3||2-sided p-value was calculated using a ANCOVA with study baseline ANC value as covariate, stratification factors of lines of systemic therapy, liver involvement and treatment as fixed effects.|ANCOVA|||Duration of SN in Cycle 1 in Group 2 vs Group 1.||2.3|-0.6|0.3364
91561700|NCT02978716|183011766|SUPERIORITY||Adjusted rate ratio|0.776|STANDARD_ERROR_OF_MEAN|0.2762||0.7048|TWO_SIDED|95.0|0.386|1.559||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|Modified Poisson method|||Number of participants with SN in Group 3 vs Group 1.||1.559|0.386|0.7048
91561701|NCT02978716|183011766|SUPERIORITY||Adjusted rate ratio|0.961|STANDARD_ERROR_OF_MEAN|0.364||0.9154|TWO_SIDED|95.0|0.457|2.019||The p-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||Number of participants with SN in Group 2 vs Group 1.||2.019|0.457|0.9154
91561702|NCT02978716|183011769|SUPERIORITY||Adjusted hazard ratio (HR)|0.4|STANDARD_ERROR_OF_MEAN|0.125||0.0004|TWO_SIDED|95.0|0.22|0.74||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 3 vs Group 1.||0.74|0.22|0.0004
91561703|NCT02978716|183011769|SUPERIORITY||Adjusted HR|0.31|STANDARD_ERROR_OF_MEAN|0.111||0.0016|TWO_SIDED|95.0|0.15|0.63||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 2 vs Group 1.||0.63|0.15|0.0016
91561704|NCT02978716|183011789|SUPERIORITY||Adjusted HR|0.493|STANDARD_ERROR_OF_MEAN|0.1957||0.7048|TWO_SIDED|95.0|0.226|1.073||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||RBC Transfusions in Group 3 vs Group 1.||1.073|0.226|0.7048
91769055|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
91561705|NCT02978716|183011789|SUPERIORITY||Adjusted rate ratio|0.885|STANDARD_ERROR_OF_MEAN|0.3089||0.7272|TWO_SIDED|95.0|0.447|1.754||P-value was calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as the stratification factors and baseline hemoglobin as a covariate.|Modified Poisson Regression|||RBC Transfusions in Group 2 vs Group 1.||1.754|0.447|0.7272
91561706|NCT02978716|183011790|SUPERIORITY||Adjusted rate ratio|0.988|STANDARD_ERROR_OF_MEAN|0.6105||0.7048|TWO_SIDED|95.0|0.294|3.317||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||Platelet Transfusions in Group 3 vs Group 1.||3.317|0.294|0.7048
91561707|NCT02978716|183011790|SUPERIORITY||Adjusted rate ratio|0.527|STANDARD_ERROR_OF_MEAN|0.4077||0.4078|TWO_SIDED|95.0|0.116|2.399||P-value: calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as stratification factors and baseline platelet count as a covariate.|Modified Poisson Regression|||Platelet Transfusions in Group 2 vs Group 1.||2.399|0.116|0.4078
91561708|NCT02978716|183011791|SUPERIORITY||Adjusted rate ratio|0.645|STANDARD_ERROR_OF_MEAN|0.1902||0.7048|TWO_SIDED|95.0|0.362|1.15||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||G-CSF Administration in Group 3 vs Group 1.||1.150|0.362|0.7048
91769056|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
91561709|NCT02978716|183011791|SUPERIORITY||Adjusted rate ratio|0.936|STANDARD_ERROR_OF_MEAN|0.226||0.7835|TWO_SIDED|95.0|0.583|1.502||P-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||G-CSF Administration in Group 2 vs Group 1.||1.502|0.583|0.7835
91561710|NCT02978716|183011794|SUPERIORITY||Adjusted rate ratio|0.991|STANDARD_ERROR_OF_MEAN|0.3718||0.7048|TWO_SIDED|95.0|0.475|2.067||The 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global family wise error rate across the multiple null hypotheses.|negative binomial regression|||All-cause Dose Reductions in Group 3 vs Group 1.||2.067|0.475|0.7048
91561711|NCT02978716|183011794|SUPERIORITY||Adjusted rate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.2744||0.5541|TWO_SIDED|95.0|0.426|1.58||P-value was calculated using negative binomial method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|negative binomial regression|||All-cause Dose Reductions in Group 2 vs Group 1.||1.580|0.426|0.5541
91561712|NCT00946998|183011801|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
91561713|NCT00946998|183011802|SUPERIORITY|||||||0.28||||||Represents the response outcome.|Mixed Models Analysis|||||||0.28
91561714|NCT00946998|183011802|SUPERIORITY|||||||0.86||||||Represents remission outcome.|Mixed Models Analysis|||||||0.86
91561715|NCT00946998|183011803|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
91561716|NCT00946998|183011804|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
91561717|NCT00946998|183011805|SUPERIORITY||||||>|0.99||||||For death|Chi-squared|||||||>.99
91561718|NCT00946998|183011805|SUPERIORITY|||||||0.77||||||For comparison of dialysis initiation between groups.|Chi-squared|||||||0.77
91561719|NCT00946998|183011805|SUPERIORITY||||||>|0.99||||||Hospitalization other than dialysis initiation|Chi-squared|||||||>0.99
91561720|NCT00946998|183011805|SUPERIORITY|||||||0.5||||||For comparison of acute suicidal intent.|Chi-squared|||||||0.5
91561721|NCT00946998|183011805|SUPERIORITY||||||>|0.99||||||For comparison of bleeding requiring blood transfusion or hospitalization.|Chi-squared|||||||>0.99
91561722|NCT03456856|183011830|SUPERIORITY||least square mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.7||0.013|TWO_SIDED|95.0|-8.0|-1.0|||repeated measures linear model|||The estimated mean treatment difference (95% CI) takes into account a presumed -5 bpm change from baseline heart rate in the absence of ivabradine (as seen in the placebo group in the SHIFT study, (NCT02441218, PMID 20801500).||-1.0|-8.0|0.013
91561723|NCT02469155|183011877|SUPERIORITY||Least Squares Mean Difference|0.1||||0.972|TWO_SIDED|95.0|-3.39|3.51|||Mixed Models for Repeated Measure|||||3.51|-3.39|0.972
91561724|NCT02469155|183011877|SUPERIORITY||Least Squares Mean Difference|0.5||||0.789|TWO_SIDED|95.0|-2.92|3.84|||Mixed Effects Model for Repeated Measure|||||3.84|-2.92|0.789
91561725|NCT02991118|183011879|SUPERIORITY||Difference in LS mean|-17.42|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-20.951|-13.896|||ANCOVA|||||-13.896|-20.951|<0.001
91561726|NCT02991118|183011880|SUPERIORITY||Difference in LS mean|-14.77|STANDARD_ERROR_OF_MEAN|2.418|<|0.001|TWO_SIDED|95.0|-19.504|-10.027|||ANCOVA|||||-10.027|-19.504|<0.001
91561727|NCT02991118|183011881|SUPERIORITY||Difference in LS mean|-13.03|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-16.27|-9.794|||ANCOVA|||||-9.794|-16.270|<0.001
91561728|NCT02991118|183011882|SUPERIORITY||Difference in LS mean|-11.2|STANDARD_ERROR_OF_MEAN|1.224|<|0.001|TWO_SIDED|95.0|-13.599|-8.801|||ANCOVA|||||-8.801|-13.599|<0.001
91561729|NCT02991118|183011883|SUPERIORITY||Difference in LS mean|-13.02|STANDARD_ERROR_OF_MEAN|1.587|<|0.001|TWO_SIDED|95.0|-16.13|-9.907|||ANCOVA|||||-9.907|-16.130|<0.001
91561730|NCT02991118|183011884|SUPERIORITY||Location shift|-8.733|||<|0.039|TWO_SIDED|95.0|-17.238|-0.434|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-0.434|-17.238|<0.039
91561731|NCT02991118|183011887|SUPERIORITY||Difference in LS mean|4.89|STANDARD_ERROR_OF_MEAN|3.258||0.134|TWO_SIDED|95.0|-1.504|11.292|||ANCOVA|||||11.292|-1.504|0.134
91561732|NCT02991118|183011888|SUPERIORITY||Difference in LS mean|-6.13|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-8.369|-3.896|||ANCOVA|||||-3.896|-8.369|<0.001
91561733|NCT02991118|183011889|SUPERIORITY||Difference in LS mean|-12.27|STANDARD_ERROR_OF_MEAN|2.314|<|0.001|TWO_SIDED|95.0|-16.813|-7.722|||ANCOVA|||||-7.722|-16.813|<0.001
91561734|NCT02991118|183011890|SUPERIORITY||Difference in LS mean|-12.63|STANDARD_ERROR_OF_MEAN|2.01|<|0.001|TWO_SIDED|95.0|-16.58|-8.682|||ANCOVA|||||-8.682|-16.580|<0.001
91561735|NCT02991118|183011891|SUPERIORITY||Difference in LS mean|-9.92|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-13.803|-6.037|||ANCOVA|||||-6.037|-13.803|<0.001
91561736|NCT02991118|183011892|SUPERIORITY||Difference in LS mean|-10.77|STANDARD_ERROR_OF_MEAN|1.489|<|0.001|TWO_SIDED|95.0|-13.698|-7.848|||ANCOVA|||||-7.848|-13.698|<0.001
91561737|NCT02991118|183011893|SUPERIORITY||Difference in LS mean|-8.36|STANDARD_ERROR_OF_MEAN|1.458|<|0.001|TWO_SIDED|95.0|-11.223|-5.493|||ANCOVA|||||-5.493|-11.223|<0.001
91561738|NCT02991118|183011894|SUPERIORITY||Difference in LS mean|-13.0|STANDARD_ERROR_OF_MEAN|2.451|<|0.001|TWO_SIDED|95.0|-17.829|-8.175|||ANCOVA|||||-8.175|-17.829|<0.001
91561739|NCT02991118|183011895|SUPERIORITY||Difference in LS mean|-9.58|STANDARD_ERROR_OF_MEAN|1.796|<|0.001|TWO_SIDED|95.0|-13.107|-6.047|||ANCOVA|||||-6.047|-13.107|<0.001
91561740|NCT02991118|183011896|SUPERIORITY||Location shift|-21.278|||<|0.001|TWO_SIDED|95.0|-32.25|-10.034|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-10.034|-32.250|<0.001
91561741|NCT02991118|183011897|SUPERIORITY||Location shift|-7.587||||0.102|TWO_SIDED|95.0|-16.978|1.653|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||1.653|-16.978|0.102
91561742|NCT02991118|183011898|SUPERIORITY||Difference in LS mean|-15.07|STANDARD_ERROR_OF_MEAN|2.641|<|0.001|TWO_SIDED|95.0|-20.26|-9.878|||ANCOVA|||||-9.878|-20.260|<0.001
91769057|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|13.3||||0.447|TWO_SIDED|95.0|-23.9|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-23.9|0.447
91561743|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and confidence intervals (CIs) were estimated from an analysis of covariance (ANCOVA) of natural log transformed values.|Ratio|1.89|||||TWO_SIDED|90.0|1.18|3.03|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as a multiplier in the Modified Diet in Renal Disease Study Group (MDRD) equation.|||3.03|1.18|
91561744|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.27|||||TWO_SIDED|90.0|1.43|3.59|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.59|1.43|
91561745|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.63|||||TWO_SIDED|90.0|1.71|4.06|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.06|1.71|
91561746|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.39|||||TWO_SIDED|90.0|0.888|2.18|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.18|0.888|
91561747|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.94|||||TWO_SIDED|90.0|1.14|3.31|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.31|1.14|
91561748|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.44|||||TWO_SIDED|90.0|1.41|4.22|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.22|1.41|
91561749|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.86|||||TWO_SIDED|90.0|1.74|4.7|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.7|1.74|
91561750|NCT00999336|183011935|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.47|||||TWO_SIDED|90.0|0.944|2.3|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.3|0.944|
91769058|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-19.3|6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||6.0|-19.3|1.000
91561751|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.88|||||TWO_SIDED|90.0|1.05|3.35|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.35|1.05|
91561752|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.32|||||TWO_SIDED|90.0|1.32|4.07|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.07|1.32|
91561753|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.52|||||TWO_SIDED|90.0|1.48|4.29|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.29|1.48|
91561754|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.34|||||TWO_SIDED|90.0|0.772|2.32|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.32|0.772|
91769059|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||28.5|-19.7|1.000
91769060|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||67.5|-27.5|0.560
91561755|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.96|||||TWO_SIDED|90.0|1.01|3.78|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.78|1.01|
91561756|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.38|||||TWO_SIDED|90.0|1.21|4.67|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.67|1.21|
91561757|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.69|||||TWO_SIDED|90.0|1.46|4.96|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.96|1.46|
91561758|NCT00999336|183011936|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.37|||||TWO_SIDED|90.0|0.793|2.38|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.38|0.793|
91561759|NCT01214109|183011944|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|82.62||||||90.0|74.45|91.69|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||91.69|74.45|
91561760|NCT01214109|183011944|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|96.17||||||90.0|69.33|133.42|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||133.42|69.33|
91561761|NCT01214109|183011945|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.01||||||90.0|80.76|95.92|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||95.92|80.76|
91561762|NCT01214109|183011945|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|89.37||||||90.0|81.16|98.42|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||98.42|81.16|
91561763|NCT01214109|183011946|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.82||||||90.0|79.89|98.76|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||98.76|79.89|
91561764|NCT01214109|183011946|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|91.97||||||90.0|60.07|140.25|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||140.25|60.07|
91561765|NCT01214109|183011947|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|92.84||||||90.0|83.8|102.86|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||102.86|83.8|
91561766|NCT01214109|183011947|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|95.05||||||90.0|84.88|106.43|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||106.43|84.88|
91561767|NCT01989156|183011968|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.27|17.05||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS Mean Ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarkers of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||17.05|9.27|<0.001
91561768|NCT01989156|183011969|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|45.77|||<|0.001|TWO_SIDED|95.0|39.22|53.41||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||53.41|39.22|<0.001
91561769|NCT01989156|183011970|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.54|16.58||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.58|9.54|<0.001
91561770|NCT01989156|183011971|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|26.41|||<|0.001|TWO_SIDED|95.0|17.31|40.26||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||40.26|17.31|<0.001
91561771|NCT01989156|183011972|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|38.14|||<|0.001|TWO_SIDED|95.0|34.24|42.47||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||42.47|34.24|<0.001
91561772|NCT00696241|183011995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.75|||<|0.001||95.0|-13.17|-8.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-8.34|-13.17|<0.001
91561773|NCT00696241|183011995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.08|||<|0.001|TWO_SIDED|95.0|-14.48|-9.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.67|-14.48|<0.001
91769061|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-20.0||||0.231|TWO_SIDED|95.0|-40.2|0.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||0.2|-40.2|0.231
91769062|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.9|-37.7|1.000
91769063|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-32.4|45.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.7|-32.4|1.000
91769064|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||18.2|-28.2|1.000
91769065|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||24.6|-29.0|1.000
91769066|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
91769067|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-11.4||||0.7|TWO_SIDED|95.0|-45.7|22.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||22.8|-45.7|0.700
91769068|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
91769069|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||69.2|-22.5|0.354
91769070|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||50.4|-18.1|0.450
91769071|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-39.1|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.8|-39.1|1.000
91769072|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||69.2|-22.5|0.354
91561774|NCT00696241|183011995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|||<|0.001|TWO_SIDED|95.0|-15.62|-10.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-10.81|-15.62|<0.001
91769073|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|9.0||||0.7|TWO_SIDED|95.0|-24.6|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.7|-24.6|0.700
91769074|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.2|0.621
91769075|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-51.8|38.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.5|-51.8|1.000
91561775|NCT00696241|183011995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.687|TWO_SIDED|95.0|-1.55|2.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||2.35|-1.55|0.687
91561776|NCT00696241|183011995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.352|TWO_SIDED|95.0|-2.87|1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||1.02|-2.87|0.352
91561777|NCT00696241|183011995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.038|TWO_SIDED|95.0|-4.0|-0.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.12|-4.00|0.038
91561778|NCT00696241|183011996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.23|||<|0.001|TWO_SIDED|95.0|-15.45|-9.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.00|-15.45|<0.001
91561779|NCT00696241|183011996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.42|||<|0.001|TWO_SIDED|95.0|-15.64|-9.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.20|-15.64|<0.001
91561780|NCT00696241|183011996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.53|||<|0.001|TWO_SIDED|95.0|-18.74|-12.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-12.31|-18.74|<0.001
91561781|NCT00696241|183011996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.662|TWO_SIDED|95.0|-2.05|3.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.22|-2.05|0.662
91561782|NCT00696241|183011996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.768|TWO_SIDED|95.0|-2.24|3.03||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.03|-2.24|0.768
91561783|NCT00696241|183011996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.043|TWO_SIDED|95.0|-5.34|-0.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.09|-5.34|0.043
91561784|NCT00696241|183011997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.34|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.34|<0.001
91561785|NCT00696241|183011997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68|||<|0.001|TWO_SIDED|95.0|-9.24|-6.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.13|-9.24|<0.001
91561786|NCT00696241|183011997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||<|0.001|TWO_SIDED|95.0|-9.47|-6.36||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-9.47|<0.001
91769076|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-39.6|0.812
91561787|NCT00696241|183011997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.679|TWO_SIDED|95.0|-0.99|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-0.99|0.679
91561788|NCT00696241|183011997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.319|TWO_SIDED|95.0|-1.89|0.62||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.62|-1.89|0.319
91561789|NCT00696241|183011997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.172|TWO_SIDED|95.0|-2.13|0.38||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.38|-2.13|0.172
91561790|NCT00696241|183011998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||<|0.001|TWO_SIDED|95.0|-8.83|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.83|<0.001
91561791|NCT00696241|183011998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.07|||<|0.001|TWO_SIDED|95.0|-8.87|-5.27||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.27|-8.87|<0.001
91561792|NCT00696241|183011998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-10.42|-6.82||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.82|-10.42|<0.001
91561793|NCT00696241|183011998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.908|TWO_SIDED|95.0|-1.39|1.56||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.56|-1.39|0.908
91561794|NCT00696241|183011998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.956|TWO_SIDED|95.0|-1.43|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-1.43|0.956
91561795|NCT00696241|183011998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.044|TWO_SIDED|95.0|-2.98|-0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.04|-2.98|0.044
91561796|NCT00696241|183011999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.03|||<|0.001|TWO_SIDED|95.0|-13.59|-8.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.48|-13.59|<0.001
91561797|NCT00696241|183011999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.001|TWO_SIDED|95.0|-14.75|-9.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.65|-14.75|<0.001
91561798|NCT00696241|183011999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||<|0.001|TWO_SIDED|95.0|-15.97|-10.86||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.86|-15.97|<0.001
91561799|NCT00696241|183011999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.879|TWO_SIDED|95.0|-1.9|2.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.22|-1.90|0.879
91561800|NCT00696241|183011999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.334|TWO_SIDED|95.0|-3.07|1.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.04|-3.07|0.334
91561801|NCT00696241|183011999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.034|TWO_SIDED|95.0|-4.28|-0.16||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-4.28|0.034
91561802|NCT00696241|183012000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|||<|0.001|TWO_SIDED|95.0|-8.79|-5.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.45|-8.79|<0.001
91769077|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
91561803|NCT00696241|183012000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.84|||<|0.001|TWO_SIDED|95.0|-9.51|-6.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.18|-9.51|<0.001
91561804|NCT00696241|183012000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||<|0.001|TWO_SIDED|95.0|-9.94|-6.61||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.61|-9.94|<0.001
91769078|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.2|-22.5|0.354
91769079|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.4|-18.1|0.450
91561805|NCT00696241|183012000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.877|TWO_SIDED|95.0|-1.24|1.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.45|-1.24|0.877
91561806|NCT00696241|183012000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.369|TWO_SIDED|95.0|-1.96|0.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.73|-1.96|0.369
91561807|NCT00696241|183012000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.126|TWO_SIDED|95.0|-2.39|0.3||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.30|-2.39|0.126
91561808|NCT00696241|183012001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.13|||<|0.001|TWO_SIDED|95.0|-12.79|-7.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-12.79|<0.001
91561809|NCT00696241|183012001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-14.07|-8.78||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.78|-14.07|<0.001
91561810|NCT00696241|183012001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.03|-9.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.73|-15.03|<0.001
91561811|NCT00696241|183012001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.346|TWO_SIDED|95.0|-1.12|3.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.18|-1.12|0.346
91561812|NCT00696241|183012001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.811|TWO_SIDED|95.0|-2.4|1.88||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.88|-2.40|0.811
91561813|NCT00696241|183012001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.267|TWO_SIDED|95.0|-3.35|0.93||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-3.35|0.267
91561814|NCT00696241|183012002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03|||<|0.001|TWO_SIDED|95.0|-7.84|-4.21||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.21|-7.84|<0.001
91561815|NCT00696241|183012002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.001|TWO_SIDED|95.0|-8.75|-5.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.13|-8.75|<0.001
91561816|NCT00696241|183012002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.65|-5.03||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-8.65|<0.001
91561817|NCT00696241|183012002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.394|TWO_SIDED|95.0|-0.83|2.1||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-0.83|0.394
91561818|NCT00696241|183012002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.712|TWO_SIDED|95.0|-1.74|1.19||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.19|-1.74|0.712
91561819|NCT00696241|183012002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.818|TWO_SIDED|95.0|-1.63|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-1.63|0.818
91561820|NCT00696241|183012003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.35|||<|0.001|TWO_SIDED|95.0|-14.05|-8.64||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.64|-14.05|<0.001
91561821|NCT00696241|183012003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-15.38|-9.98||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.98|-15.38|<0.001
91561822|NCT00696241|183012003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.81|||<|0.001|TWO_SIDED|95.0|-16.51|-11.11||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.11|-16.51|<0.001
91561823|NCT00696241|183012003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.75|TWO_SIDED|95.0|-1.83|2.54||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.54|-1.83|0.750
91561824|NCT00696241|183012003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.378|TWO_SIDED|95.0|-3.16|1.2||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-3.16|0.378
91769080|NCT02365649|183425730|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||17.9|-46.2|0.621
91769081|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20%of the cells have expected cell count \<5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||95.6|-62.2|1.000
91561825|NCT00696241|183012003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.059|TWO_SIDED|95.0|-4.28|0.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.08|-4.28|0.059
91561826|NCT00696241|183012004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.02|-5.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.48|-9.02|<0.001
91561827|NCT00696241|183012004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-9.92|-6.4||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.40|-9.92|<0.001
91561828|NCT00696241|183012004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-10.17|-6.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.65|-10.17|<0.001
91561829|NCT00696241|183012004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.845|TWO_SIDED|95.0|-1.29|1.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.57|-1.29|0.845
91561830|NCT00696241|183012004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.29|TWO_SIDED|95.0|-2.19|0.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.65|-2.19|0.290
91561831|NCT00696241|183012004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.161|TWO_SIDED|95.0|-2.44|0.41||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.41|-2.44|0.161
91561832|NCT00696241|183012005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.94|||<|0.001|TWO_SIDED|95.0|-13.88|-8.0||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.00|-13.88|<0.001
91561833|NCT00696241|183012005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|||<|0.001|TWO_SIDED|95.0|-14.11|-8.24||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.24|-14.11|<0.001
91561834|NCT00696241|183012005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.21|||<|0.001|TWO_SIDED|95.0|-15.15|-9.28||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.28|-15.15|<0.001
91561835|NCT00696241|183012005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.385|TWO_SIDED|95.0|-3.43|1.33||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.33|-3.43|0.385
91561836|NCT00696241|183012005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.285|TWO_SIDED|95.0|-3.66|1.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.08|-3.66|0.285
91561837|NCT00696241|183012005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.054|TWO_SIDED|95.0|-4.7|0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.04|-4.70|0.054
91561838|NCT00696241|183012006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.93|-4.75||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.75|-8.93|<0.001
91561839|NCT00696241|183012006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-8.89|-4.72||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.72|-8.89|<0.001
91561840|NCT00696241|183012006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-9.64|-5.47||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.47|-9.64|<0.001
91561841|NCT00696241|183012006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.642|TWO_SIDED|95.0|-2.09|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-2.09|0.642
91561842|NCT00696241|183012006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.672|TWO_SIDED|95.0|-2.05|1.32||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.32|-2.05|0.672
91561843|NCT00696241|183012006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.57|-2.80|0.196
91561844|NCT00696241|183012007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|2.71|7.39||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.39|2.71|<0.001
91561845|NCT00696241|183012007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.001|TWO_SIDED|95.0|3.01|8.2||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.20|3.01|<0.001
91561846|NCT00696241|183012007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.95|10.79||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||10.79|3.95|<0.001
91561847|NCT00696241|183012007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.173|TWO_SIDED|95.0|0.57|1.11||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.11|0.57|0.173
91561848|NCT00696241|183012007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.449|TWO_SIDED|95.0|0.63|1.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.23|0.63|0.449
91561849|NCT00696241|183012007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.402|TWO_SIDED|95.0|0.83|1.62||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.62|0.83|0.402
91561850|NCT00696241|183012008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.82|4.48||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.48|1.82|<0.001
91561851|NCT00696241|183012008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|2.15|5.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.35|2.15|<0.001
91561852|NCT00696241|183012008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.41|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.41|<0.001
91561853|NCT00696241|183012008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.52|1.13||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.52|0.177
91561854|NCT00696241|183012008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.61|1.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.35|0.61|0.628
91561855|NCT00696241|183012008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.928|TWO_SIDED|95.0|0.68|1.52||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.52|0.68|0.928
91561856|NCT00696241|183012009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.001|TWO_SIDED|95.0|2.66|7.72||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.72|2.66|<0.001
91561857|NCT00696241|183012009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.001|TWO_SIDED|95.0|2.96|8.58||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.58|2.96|<0.001
91561858|NCT00696241|183012009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.75|||<|0.001|TWO_SIDED|95.0|3.96|11.48||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||11.48|3.96|<0.001
91561859|NCT00696241|183012009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.217|TWO_SIDED|95.0|0.58|1.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.58|0.217
91561860|NCT00696241|183012009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.537|TWO_SIDED|95.0|0.64|1.26||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.26|0.64|0.537
91561861|NCT00696241|183012009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.276|TWO_SIDED|95.0|0.86|1.68||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.68|0.86|0.276
91561862|NCT00762853|183012021|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91561863|NCT02429115|183012033|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91561864|NCT02429115|183012034|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91561865|NCT02429115|183012035|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
91561866|NCT01047709|183012091|SUPERIORITY_OR_OTHER||relative % difference|19.5|STANDARD_DEVIATION|23.0||0.011|TWO_SIDED|95.0|4.9|31.9|||GEE||SD of control night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
91561867|NCT01047709|183012091|SUPERIORITY_OR_OTHER||Relative % difference|19.5|STANDARD_DEVIATION|16.0||0.011||95.0|4.9|31.9|||GEE||SD of intervention night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
91561868|NCT02291549|183012092|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.0074|TWO_SIDED|95.0|-0.39|-0.06||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.|ANCOVA|Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.39|0.0074
91561869|NCT02291549|183012093|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.6|-0.09||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.|ANCOVA|ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.||The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.09|-0.60|0.0073
91561870|NCT02291549|183012094|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0004|TWO_SIDED|95.0|1.63|4.44||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted p-value is presented.||Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test||4.44|1.63|0.0004
91561871|NCT02291549|183012095|SUPERIORITY||Mean Difference (Final Values)|-7.96||||0.0007|TWO_SIDED|95.0|-12.1|-3.83||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.||-3.83|-12.10|0.0007
91561872|NCT02291549|183012096|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.0248|TWO_SIDED|95.0|-0.48|-0.07||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.07|-0.48|0.0248
91769082|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||79.6|-21.3|0.592
91561873|NCT02291549|183012097|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.047|TWO_SIDED|95.0|-0.85|-0.06||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|The adjusted p-value is presentenced.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.85|0.0470
91561874|NCT02291549|183012098|SUPERIORITY|||||||0.913||||||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||||0.9130
91561875|NCT02470806|183012134|NON_INFERIORITY|Stepwise regression method - Primary efficacy analysis, difference between treatment groups in percentage change in wound area from baseline visit to end of 12-week treatment period for the PP population.||||||0.001|TWO_SIDED|95.0|||||Stepwise regression|||Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)||||0.001
91561876|NCT00866619|183012139|SUPERIORITY|Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|55.8|||<|0.0001|TWO_SIDED|97.5|50.6|60.4|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[5-17M\] Group (HR1) divided by HR in control VeroRab Comparator \[5-17M\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||60.4|50.6|<0.0001
91561877|NCT00866619|183012140|SUPERIORITY|Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|31.315|||<|0.0001|TWO_SIDED|97.5|23.556|38.286|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[6-12W\] Group (HR1) divided by HR in control Menjugate Comparator \[6-12W\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||38.286|23.556|<0.0001
91561878|NCT01307800|183012216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.994|TWO_SIDED|95.0|-0.5|8.8||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||8.8|-0.5|0.994
91561879|NCT01307800|183012216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.973|TWO_SIDED|95.0|-1.9|7.9||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||7.9|-1.9|0.973
91769083|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||38.2|-64.8|1.000
91561880|NCT01307800|183012216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|2.2||0.896|TWO_SIDED|95.0|-1.6|7.2||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.2|-1.6|0.896
91769084|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-80.0|80.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||80.0|-80.0|1.000
91769085|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||64.7|-39.7|1.000
91769086|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-30.0||||0.545|TWO_SIDED|95.0|-83.2|23.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||23.2|-83.2|0.545
91769087|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|50.0||||0.464|TWO_SIDED|95.0|10.0|90.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||90.0|10.0|0.464
91769088|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||64.7|-39.7|1.000
91769089|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-50.0||||0.182|TWO_SIDED|95.0|-90.0|-10.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-10.0|-90.0|0.182
91769090|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||95.6|-62.2|1.000
91561881|NCT01307800|183012217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.5||0.955|TWO_SIDED|95.0|-0.7|9.3||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||9.3|-0.7|0.955
91561882|NCT01307800|183012217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.912|TWO_SIDED|95.0|-1.6|8.4||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||8.4|-1.6|0.912
91561883|NCT01307800|183012217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.4||0.223|TWO_SIDED|95.0|-1.8|7.7||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.7|-1.8|0.223
91561884|NCT01307800|183012218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.5||0.61|TWO_SIDED|95.0|-3.5|2.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.6|-3.5|0.610
91561885|NCT01307800|183012218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.223|TWO_SIDED|95.0|-2.0|4.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.6|-2.0|0.223
91769091|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||79.6|-21.3|0.592
91769092|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||38.2|-64.8|1.000
91561886|NCT01307800|183012218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.5||0.414|TWO_SIDED|95.0|-4.2|1.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.7|-4.2|0.414
91561887|NCT01307800|183012219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.603|TWO_SIDED|95.0|-3.7|2.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-3.7|0.603
91561888|NCT01307800|183012219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.192|TWO_SIDED|95.0|-1.9|4.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.8|-1.9|0.192
91561889|NCT01307800|183012219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.619|TWO_SIDED|95.0|-3.9|2.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.3|-3.9|0.619
91561890|NCT01307800|183012220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.5|STANDARD_ERROR_OF_MEAN|4.1||0.022|TWO_SIDED|95.0|1.4|17.6||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.6|1.4|0.022
91561891|NCT01307800|183012220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|STANDARD_ERROR_OF_MEAN|4.6||0.061|TWO_SIDED|95.0|-0.4|17.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.8|-0.4|0.061
91561892|NCT01307800|183012220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.2|STANDARD_ERROR_OF_MEAN|4.1||0.304|TWO_SIDED|95.0|-3.9|12.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||12.3|-3.9|0.304
91561893|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|0.8||0.036|TWO_SIDED|95.0|0.1|3.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.1|0.1|0.036
91561894|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.616|TWO_SIDED|95.0|-1.2|2.0||The comparison between 40 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-1.2|0.616
91561895|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.307|TWO_SIDED|95.0|-0.7|2.2||The comparison between 10 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.2|-0.7|0.307
91561896|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.382|TWO_SIDED|95.0|-0.8|2.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.1|-0.8|0.382
91561897|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.107|TWO_SIDED|95.0|-0.3|2.8||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-0.3|0.107
91561898|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.436|TWO_SIDED|95.0|-0.9|2.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-0.9|0.436
91561899|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.073|TWO_SIDED|95.0|-0.2|4.9||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.9|-0.2|0.073
91561900|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.4||0.28|TWO_SIDED|95.0|-1.2|4.2||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.2|-1.2|0.280
91561901|NCT01307800|183012221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.3||0.209|TWO_SIDED|95.0|-0.9|4.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.0|-0.9|0.209
91561902|NCT01307800|183012222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.137||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.137
91561903|NCT01307800|183012222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.824||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.824
91561904|NCT01307800|183012222|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||>0.999
91561905|NCT01307800|183012224|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.34|TWO_SIDED|95.0|-0.13|0.38||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.13|0.340
91561906|NCT01307800|183012224|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.659|TWO_SIDED|95.0|-0.33|0.21||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.21|-0.33|0.659
91561907|NCT01307800|183012224|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.413|TWO_SIDED|95.0|-0.14|0.35||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.35|-0.14|0.413
91561908|NCT01307800|183012225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.5||0.91|TWO_SIDED|95.0|-3.1|2.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.7|-3.1|0.910
91561909|NCT01307800|183012225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.6||0.265|TWO_SIDED|95.0|-4.9|1.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.3|-4.9|0.265
91561910|NCT01307800|183012225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.4||0.531|TWO_SIDED|95.0|-3.7|1.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.9|-3.7|0.531
91561911|NCT01307800|183012226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|2.62||0.983|TWO_SIDED|95.0|-5.21|5.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||5.10|-5.21|0.983
91561912|NCT01307800|183012226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|2.74||0.351|TWO_SIDED|95.0|-7.94|2.83||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||2.83|-7.94|0.351
91561913|NCT01307800|183012226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|2.54||0.403|TWO_SIDED|95.0|-2.86|7.11||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||7.11|-2.86|0.403
91561914|NCT01307800|183012229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.4||0.021|TWO_SIDED|95.0|-10.4|-0.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||-0.8|-10.4|0.021
91561915|NCT01307800|183012229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|2.6||0.487|TWO_SIDED|95.0|-3.3|6.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||6.9|-3.3|0.487
91561916|NCT01307800|183012229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.693|TWO_SIDED|95.0|-5.6|3.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.7|-5.6|0.693
91561917|NCT01307800|183012230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.661|TWO_SIDED|95.0|-0.1|0.06||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.10|0.661
91561918|NCT01307800|183012230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.201|TWO_SIDED|95.0|-0.14|0.03||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.03|-0.14|0.201
91561919|NCT01307800|183012230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.697|TWO_SIDED|95.0|-0.09|0.06||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.09|0.697
91561920|NCT01307800|183012231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.694|TWO_SIDED|95.0|-0.2|0.31||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.31|-0.20|0.694
91561921|NCT01307800|183012231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.596|TWO_SIDED|95.0|-0.34|0.2||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.20|-0.34|0.596
91561922|NCT01307800|183012231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.13||0.055|TWO_SIDED|95.0|0.0|0.49||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.49|0.00|0.055
91561923|NCT01307800|183012232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.929|TWO_SIDED|95.0|-0.27|0.29||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.29|-0.27|0.929
91561924|NCT01307800|183012232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.19|0.38||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.19|0.519
91561925|NCT01307800|183012232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.14||0.323|TWO_SIDED|95.0|-0.13|0.4||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.40|-0.13|0.323
91561926|NCT01307800|183012233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0||||The comparison between 80 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.758
91561927|NCT01307800|183012233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||95.0||||The comparison between 40 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.576
91561928|NCT01307800|183012233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.425||95.0||||The comparison between 10 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.425
91561929|NCT01307800|183012236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.444||95.0||||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) model on rank-transformed change.||||||0.444
91561930|NCT01307800|183012236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.799
91561931|NCT01307800|183012236|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0||||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.073
91561932|NCT01307800|183012237|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.46||0.761|TWO_SIDED|95.0|-0.76|1.04||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.04|-0.76|0.761
91561933|NCT01307800|183012237|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.47||0.761|TWO_SIDED|95.0|-0.78|1.06||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.06|-0.78|0.761
91561934|NCT01307800|183012237|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.489|TWO_SIDED|95.0|-1.17|0.56||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.56|-1.17|0.489
91561935|NCT05062343|183012239|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
91561936|NCT05062343|183012240|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91561937|NCT05062343|183012241|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91561938|NCT05062343|183012242|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
91561939|NCT05062343|183012243|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
91561940|NCT05062343|183012244|SUPERIORITY|||||||0.045|||||||Chi-squared|||||||0.045
91561941|NCT05062343|183012245|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91561942|NCT05062343|183012246|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
91561943|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.77|||||TWO_SIDED|95.0|0.62|0.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||0.97|0.62|
91561944|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.17|||||TWO_SIDED|95.0|0.87|1.57|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.57|0.87|
91561945|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.73|1.07|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.07|0.73|
91561946|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.7|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.70|
91561947|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97|||||TWO_SIDED|95.0|0.79|1.18|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.18|0.79|
91561948|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.71|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.71|
91561949|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.8|1.36|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.36|0.80|
91561950|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|329.44|||||TWO_SIDED|95.0|242.98|446.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||446.67|242.98|
91561951|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|40.79|||||TWO_SIDED|95.0|30.27|54.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||54.97|30.27|
91561952|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|13.12|||||TWO_SIDED|95.0|9.92|17.34|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||17.34|9.92|
91561953|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|9.01|||||TWO_SIDED|95.0|6.46|12.56|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||12.56|6.46|
91561954|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|165.9|||||TWO_SIDED|95.0|122.95|223.85|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||223.85|122.95|
91561955|NCT00689351|183012258|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.24|||||TWO_SIDED|95.0|1.83|2.75|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||2.75|1.83|
91561956|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.78|||||TWO_SIDED|95.0|0.6|1.02|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.60|
91561957|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.11|||||TWO_SIDED|95.0|0.83|1.48|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.48|0.83|
91769093|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|66.7||||0.429|TWO_SIDED|95.0|28.9|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||100.0|28.9|0.429
91769094|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||79.6|-21.3|0.592
91561958|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.95|||||TWO_SIDED|95.0|0.76|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.76|
91561959|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.74|||||TWO_SIDED|95.0|0.57|0.95|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||0.95|0.57|
91561960|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.72|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.72|
91561961|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.45|||||TWO_SIDED|95.0|1.11|1.88|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.88|1.11|
91561962|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.78|1.4|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.40|0.78|
91561963|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|234.33|||||TWO_SIDED|95.0|176.33|311.41|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||311.41|176.33|
91561964|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|16.63|||||TWO_SIDED|95.0|12.19|22.69|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||22.69|12.19|
91561965|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|6.84|||||TWO_SIDED|95.0|5.39|8.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||8.67|5.39|
91561966|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.08|||||TWO_SIDED|95.0|3.07|5.43|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||5.43|3.07|
91561967|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|110.92|||||TWO_SIDED|95.0|77.09|159.59|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||159.59|77.09|
91561968|NCT00689351|183012259|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.25|||||TWO_SIDED|95.0|3.39|5.33|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||5.33|3.39|
91561969|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.862|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.862
91561970|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.157|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.157
91561971|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.550
91561972|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.052
91561973|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.366|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.366
91561974|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.301|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.301
91561975|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.362
91561976|NCT00689351|183012260|SUPERIORITY_OR_OTHER|||||||0.718|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.718
91561977|NCT00689351|183012261|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||>0.99
91561978|NCT00689351|183012261|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.245
91561979|NCT00689351|183012261|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.447
91561980|NCT00689351|183012261|SUPERIORITY_OR_OTHER|||||||0.684|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.684
91561981|NCT00689351|183012261|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||>0.99
91561982|NCT00689351|183012261|SUPERIORITY_OR_OTHER|||||||0.578|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.578
91561983|NCT00689351|183012261|SUPERIORITY_OR_OTHER|||||||0.451|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.451
91561984|NCT00689351|183012261|SUPERIORITY_OR_OTHER|||||||0.712|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.712
91561985|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.681|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.681
91561986|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.482|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.482
91561987|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.683|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.683
91561988|NCT00689351|183012262|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||>0.99
91561989|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.533|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.533
91561990|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.692|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.692
91561991|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.662
91769095|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-33.3||||0.455|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||4.4|-71.1|0.455
91769096|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|31.7||||0.191|TWO_SIDED|95.0|-14.0|77.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||77.4|-14.0|0.191
91561992|NCT00689351|183012262|SUPERIORITY_OR_OTHER|||||||0.331|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.331
91561993|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.409|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.409
91561994|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.617|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.617
91561995|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.807|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.807
91561996|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.527
91561997|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.144|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.144
91561998|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.495|||||||Fisher Exact|||Comparison between treatments for severe swelling.||||0.495
91561999|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.506|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.506
91769097|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||22.1|-22.1|1.000
91562000|NCT00689351|183012263|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild redness.||||>0.99
91562001|NCT00689351|183012263|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.200
91562002|NCT00689351|183012264|SUPERIORITY_OR_OTHER|||||||0.633|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.||||0.633
91562003|NCT00689351|183012264|SUPERIORITY_OR_OTHER|||||||0.721|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.721
91562004|NCT00689351|183012264|SUPERIORITY_OR_OTHER|||||||0.009|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.009
91562005|NCT00689351|183012264|SUPERIORITY_OR_OTHER|||||||0.253|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.253
91562006|NCT00689351|183012264|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.143
91562007|NCT00689351|183012265|SUPERIORITY_OR_OTHER|||||||0.781|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.781
91562008|NCT00689351|183012265|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.060
91562009|NCT00689351|183012265|SUPERIORITY_OR_OTHER|||||||0.159|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.159
91562010|NCT00689351|183012265|SUPERIORITY_OR_OTHER|||||||0.839|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.839
91562011|NCT00689351|183012265|SUPERIORITY_OR_OTHER|||||||0.264|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.264
91562012|NCT00689351|183012266|SUPERIORITY_OR_OTHER|||||||0.563|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.563
91562013|NCT00689351|183012266|SUPERIORITY_OR_OTHER|||||||0.468|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||0.468
91562014|NCT00689351|183012266|SUPERIORITY_OR_OTHER|||||||0.535|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.535
91562015|NCT00689351|183012266|SUPERIORITY_OR_OTHER|||||||0.019|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.019
91562016|NCT00689351|183012266|SUPERIORITY_OR_OTHER|||||||0.398|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.398
91562017|NCT00689351|183012266|SUPERIORITY_OR_OTHER|||||||0.125|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.125
91562018|NCT00689351|183012267|SUPERIORITY_OR_OTHER|||||||0.596|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.596
91769098|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-24.0|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||7.3|-24.0|1.000
91769099|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||71.2|-24.5|0.538
91562019|NCT00689351|183012267|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||>0.99
91562020|NCT00689351|183012267|SUPERIORITY_OR_OTHER|||||||0.663|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.663
91562021|NCT00689351|183012267|SUPERIORITY_OR_OTHER|||||||0.439|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.439
91562022|NCT00689351|183012267|SUPERIORITY_OR_OTHER|||||||0.613|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.613
91562023|NCT00689351|183012267|SUPERIORITY_OR_OTHER|||||||0.138|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.138
91562024|NCT01313663|183012278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|90.0|0.32|2.65|||||HRs were estimated using the Pike estimator. The hazard ratio and p-value from the stratified log-rank test were adjusted for disease stage at Baseline only, due to sparse data.|||2.65|0.32|
91562025|NCT05356130|183012325|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||"We conducted the same two independent planned comparisons: Enhanced BLT Encouragement + Adherence Promotion compared to Minimal BLT Encouragement; Minimal BLT Encouragement and Enhanced BLT Encouragement + Adherence Promotion compared to TAU."||||0.014
91562026|NCT02680314|183012327|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
91562027|NCT00234832|183012358|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.162||||0.015|TWO_SIDED|95.0|1.029|1.311||No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.|Log Rank||The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.|For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.||1.311|1.029|0.015
91562028|NCT00234832|183012358|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.948|TWO_SIDED|95.0|0.738|1.384|||Log Rank|||This analysis included only subjects with DM only in a comparison of sibutramine and placebo.||1.384|0.738|0.948
91562029|NCT00234832|183012358|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.149|TWO_SIDED|95.0|0.916|1.776|||Log Rank|||This analysis included only subjects with CV only in a comparison of sibutramine and placebo.||1.776|0.916|0.149
91562030|NCT00234832|183012358|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.182||||0.022|TWO_SIDED|95.0|1.024|1.365|||Log Rank|||This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.||1.365|1.024|0.022
91562031|NCT00234832|183012359|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.043||||0.543|TWO_SIDED|95.0|0.91|1.196|||Log Rank|||||1.196|0.910|0.543
91562032|NCT00234832|183012360|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.097||||0.051|TWO_SIDED|95.0|0.999|1.204|||Log Rank|||||1.204|0.999|0.051
91562033|NCT00234832|183012361|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.022|TWO_SIDED|95.0|1.036|1.571|||Log Rank|||||1.571|1.036|0.022
91562034|NCT00234832|183012362|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.355||||0.025|TWO_SIDED|95.0|1.038|1.767|||Log Rank|||||1.767|1.038|0.025
91562035|NCT00234832|183012363|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.582||||0.343|TWO_SIDED|95.0|0.613|4.081|||Log Rank|||||4.081|0.613|0.343
91562036|NCT00234832|183012364|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.988||||0.899|TWO_SIDED|95.0|0.822|1.188|||Log Rank|||||1.188|0.822|0.899
91562037|NCT04454125|183012407|SUPERIORITY||Odds Ratio (OR)|0.61||||0.32|TWO_SIDED|95.0|0.23|1.61|||Generalized linear model, repeat measure|Generalized linear model (GLM) fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group arm, visit, interaction term (arm\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.61|0.23|0.32
91769100|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-29.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||29.8|-29.8|1.000
91562038|NCT04454125|183012407|SUPERIORITY||Odds Ratio (OR)|0.31||||0.29|TWO_SIDED|95.0|0.03|2.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||2.76|0.03|0.29
91562039|NCT04454125|183012407|SUPERIORITY||Odds Ratio (OR)|0.51||||0.58|TWO_SIDED|95.0|0.05|5.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link||Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|5.68|0.05|0.58
91562040|NCT04454125|183012407|SUPERIORITY||Odds Ratio (OR)|0.5||||0.02|TWO_SIDED|95.0|0.27|0.91|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.91|0.27|0.02
91562041|NCT04454125|183012407|SUPERIORITY||Odds Ratio (OR)|0.23||||0.03|TWO_SIDED|95.0|0.06|0.86|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.86|0.06|0.03
91562042|NCT04454125|183012407|SUPERIORITY||Odds Ratio (OR)|0.47||||0.3|TWO_SIDED|95.0|0.11|1.95|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.95|0.11|0.30
91562043|NCT04454125|183012408|SUPERIORITY||Mean Difference (Net)|0.17||||0.8|TWO_SIDED|95.0|-1.17|1.51|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||1.51|-1.17|0.80
91562044|NCT04454125|183012408|SUPERIORITY||Mean Difference (Net)|2.02||||0.001|TWO_SIDED|95.0|0.88|3.15|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.15|0.88|0.001
91562045|NCT04454125|183012408|SUPERIORITY||Mean Difference (Net)|1.85||||0.04|TWO_SIDED|95.0|0.09|3.61|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.61|0.09|0.04
91562046|NCT04454125|183012408|SUPERIORITY||Mean Difference (Net)|-0.31||||0.7|TWO_SIDED|95.0|-1.87|1.25|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||1.25|-1.87|0.70
91562047|NCT04454125|183012408|SUPERIORITY||Mean Difference (Net)|3.96||||0.14|TWO_SIDED|95.0|-1.27|9.2|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||9.20|-1.27|0.14
91562048|NCT04454125|183012408|SUPERIORITY||Mean Difference (Net)|4.27||||0.13|TWO_SIDED|95.0|-1.19|9.73|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Scores.||9.73|-1.19|0.13
91562049|NCT04454125|183012409|SUPERIORITY||Mean Difference (Net)|0.25||||0.11|TWO_SIDED|95.0|-0.06|0.55|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.55|-0.06|0.11
91562050|NCT04454125|183012409|SUPERIORITY||Mean Difference (Net)|0.54||||0.002|TWO_SIDED|95.0|0.2|0.88|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.88|0.20|0.002
91562051|NCT04454125|183012409|SUPERIORITY||Mean Difference (Net)|0.3||||0.2|TWO_SIDED|95.0|-0.16|0.75|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.75|-0.16|0.20
91562052|NCT04454125|183012410|SUPERIORITY||Odds Ratio (OR)|0.94||||0.87|TWO_SIDED|95.0|0.45|1.96|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||1.96|0.45|0.87
91562053|NCT04454125|183012410|SUPERIORITY||Odds Ratio (OR)|6.89||||0.004|TWO_SIDED|95.0|1.85|25.6|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||25.6|1.85|0.004
91562054|NCT04454125|183012410|SUPERIORITY||Odds Ratio (OR)|7.31||||0.01|TWO_SIDED|95.0|1.62|32.9|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||32.9|1.62|0.01
91562055|NCT04454125|183012411|SUPERIORITY||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.47|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||1.47|0.08|0.15
91562056|NCT04454125|183012411|SUPERIORITY||Odds Ratio (OR)|0.96||||0.94|TWO_SIDED|95.0|0.35|2.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||2.68|0.35|0.94
91562057|NCT04454125|183012411|SUPERIORITY||Odds Ratio (OR)|2.79||||0.26|TWO_SIDED|95.0|0.47|16.5|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||16.5|0.47|0.26
91562058|NCT04454125|183012412|SUPERIORITY||Odds Ratio (OR)|0.42||||0.004|TWO_SIDED|95.0|0.24|0.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits||0.76|0.24|0.004
91562059|NCT04454125|183012412|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.31|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.31|0.05|<0.0001
91562060|NCT04454125|183012412|SUPERIORITY||Odds Ratio (OR)|0.29||||0.03|TWO_SIDED|95.0|0.1|0.87|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.87|0.10|0.03
91562061|NCT01922102|183012413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2|||<|0.001|TWO_SIDED|95.0|3.3|7.1||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.||7.1|3.3|<0.001
91562062|NCT01922102|183012413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.5|7.6||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|"The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:~H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively."||7.6|3.5|<0.001
91562063|NCT01922102|183012414|NON_INFERIORITY_OR_EQUIVALENCE|"one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I \> -5.~Otherwise, H03 was not to be considered as rejected."|Mean Difference (Net)|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|||2.1|-1.3|<0.001
91562064|NCT01383616|183012482|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups||||0.85
91562065|NCT01383616|183012483|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
91562066|NCT01383616|183012484|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91562067|NCT01383616|183012485|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
91562068|NCT01383616|183012486|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91562069|NCT01383616|183012487|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
91562070|NCT01383616|183012488|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
91562071|NCT01383616|183012489|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
91562072|NCT01383616|183012490|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
91562073|NCT01383616|183012491|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
91769101|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||27.0|-35.3|1.000
91562074|NCT00896389|183012492|OTHER|Association between genotypes and phenotypes were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
91562075|NCT00896389|183012493|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||<|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||||||<0.05
91562076|NCT00896389|183012494|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
91562077|NCT00896389|183012495|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
91562078|NCT00896389|183012496|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
91562079|NCT00896389|183012497|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
91562080|NCT00896389|183012498|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
91562081|NCT00896389|183012499|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
91562082|NCT00896389|183012500|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
91769102|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||50.1|-26.7|0.515
91562083|NCT00896389|183012501|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05|||||||Chi-squared|Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
91562084|NCT03184519|183012509|SUPERIORITY||Area Under Curve|0.79||||0.025|ONE_SIDED||||||t-test, 1 sided|||||||0.025
91562085|NCT02823574|183012515|SUPERIORITY||Odds Ratio (OR)|0.68||||0.2897|TWO_SIDED|95.5|0.33|1.43|||Mantel Haenszel|||Treatment A over Treatment B||1.43|0.33|0.2897
91562086|NCT02823574|183012520|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status|||1.41|0.78|
91562087|NCT02823574|183012521|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.41|0.78|
91562088|NCT02823574|183012522|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.36|0.87|
91562089|NCT02823574|183012523|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.45|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.45|0.81|
91562090|NCT02823574|183012524|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.81|1.61|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.61|0.81|
91562091|NCT02823574|183012549|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.32|1.29|||Mantel Haenszel|||Treatment A over Treatment B||1.29|0.32|
91562092|NCT01580306|183012554|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|113.57|STANDARD_DEVIATION|93.2|||TWO_SIDED|90.0|41.58|310.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||310.17|41.58|
91562093|NCT01580306|183012554|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|178.31|STANDARD_DEVIATION|78.9|||TWO_SIDED|90.0|85.23|373.03|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||373.03|85.23|
91562094|NCT01580306|183012554|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|169.21|STANDARD_DEVIATION|97.7|||TWO_SIDED|90.0|73.19|391.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||391.17|73.19|
91562095|NCT01580306|183012555|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|107.22|STANDARD_DEVIATION|107.7|||TWO_SIDED|90.0|35.16|327.01|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||327.01|35.16|
91562096|NCT01580306|183012555|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|175.52|STANDARD_DEVIATION|70.4|||TWO_SIDED|90.0|89.55|344.06|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||344.06|89.55|
91562097|NCT01580306|183012555|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|120.98|STANDARD_DEVIATION|115.0|||TWO_SIDED|90.0|47.257|309.736|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||309.736|47.257|
91562098|NCT02105688|183012579|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided exact test|||A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value \<0.025 supports a conclusion that the true SVR12 is \>67%.||||<0.001
91562099|NCT02105688|183012580|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-8.3|10.0||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-8.3|
91562100|NCT02105688|183012581|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-5.0|1.9||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||1.9|-5.0|
91562101|NCT00887471|183012586|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance was P\<.05.|Mixed Models Analysis|||The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.||||.590
91562102|NCT00887471|183012586|SUPERIORITY_OR_OTHER|||||||0.022||||||P value for the variances. The a priori threshold for statistical significance was P \< .05.|Mixed Models Analysis|||A mixed linear model was constructed as described above. Variance was estimated separately for each group.||||.022
91562103|NCT00887471|183012587|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.||||1.00
91562104|NCT00636168|183012590|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0013|TWO_SIDED|95.0|0.64|0.9|||Log Rank|stratified 2-sided log-rank test||The hazard ratio, and its 95 % confidence interval was estimated using a Cox proportional hazards model, stratified by stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as indicated at randomization, with treatment as the single covariate.. The analysis was performed after 528 RFS events per IRC were reported. Two-sided, 95% confidence intervals for median RFS were computed by the Brookmeyer and Crowley method using log-log transformation.||0.90|0.64|0.0013
91769103|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||22.1|-22.1|1.000
91562105|NCT00636168|183012593|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0024|TWO_SIDED|95.8|0.64|0.92|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.8% confidence interval are based on a stratified Cox proportional hazards model||0.92|0.64|0.0024
91562106|NCT00636168|183012596|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0013|TWO_SIDED|95.1|0.58|0.88|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model||0.88|0.58|0.0013
91562107|NCT00780741|183012626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.09|TWO_SIDED|95.0|-0.01|0.21|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||0.21|-0.01|0.09
91562108|NCT00780741|183012627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-139.0||||0.24|TWO_SIDED|95.0|-377.0|94.0|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||94|-377|0.24
91562109|NCT00780741|183012628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.8|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||-1.8|-4.0|<0.0001
91562110|NCT00623714|183012649|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.34||||0.011|TWO_SIDED|90.0|0.16|0.7||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.70|0.16|0.011
91769104|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||31.9|-23.6|1.000
91769105|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||71.2|-24.5|0.538
91562111|NCT00623714|183012650|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.4||||0.002|TWO_SIDED|95.0|0.26|0.63||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.63|0.26|0.002
91562112|NCT02367794|183012651|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0006|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0006
91562113|NCT02367794|183012652|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1581|TWO_SIDED|95.0|0.73|1.05|||Log Rank|||||1.05|0.73|0.1581
91562114|NCT02367794|183012653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.876||||0.4451|TWO_SIDED|95.0|0.623|1.231|||Log Rank|||Teff \>=-1.91 in ITT||1.231|0.623|0.4451
91562115|NCT02367794|183012653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.941||||0.7343|TWO_SIDED|95.0|0.664|1.335|||Log Rank|||Teff \>=-1.91 in ITT||1.335|0.664|0.7343
91562116|NCT02367794|183012653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.942||||0.661|TWO_SIDED|95.0|0.72|1.232|||Log Rank|||Teff \<-1.91 Negative in ITT||1.232|0.720|0.6610
91562117|NCT02367794|183012653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.253||||0.0893|TWO_SIDED|95.0|0.965|1.627|||Log Rank|||Teff \<-1.91 Negative in ITT||1.627|0.965|0.0893
91562118|NCT02367794|183012654|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61||||0.0006|TWO_SIDED|95.0|0.46|0.81|||Log Rank|||Teff\>=-1.91||0.81|0.46|0.0006
91562119|NCT02367794|183012654|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\>=-1.91||1.33|0.84|0.630
91562120|NCT02367794|183012654|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.88||||0.258|TWO_SIDED|95.0|0.7|1.1|||Log Rank|||Teff\<-1.91||1.10|0.70|0.258
91562121|NCT02367794|183012654|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\<-1.91||1.33|0.84|0.630
91562122|NCT02367794|183012655|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|||||0.72|0.40|<.0001
91562123|NCT02367794|183012655|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61||||0.0018|TWO_SIDED|95.0|0.45|0.84|||Log Rank|||||0.84|0.45|0.0018
91562124|NCT02367794|183012656|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
91562125|NCT02367794|183012656|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
91562126|NCT02367794|183012657|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.725||||0.0518|TWO_SIDED|95.0|0.524|1.004|||Log Rank|||||1.004|0.524|0.0518
91562127|NCT02367794|183012657|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.832||||0.2841|TWO_SIDED|95.0|0.594|1.165|||Log Rank|||||1.165|0.594|0.2841
91562128|NCT02367794|183012658|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.871||||0.2956|TWO_SIDED|95.0|0.671|1.129|||Log Rank|||||1.129|0.671|0.2956
91562129|NCT02367794|183012658|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.861||||0.2473|TWO_SIDED|95.0|0.668|1.109|||Log Rank|||||1.109|0.668|0.2473
91562130|NCT02367794|183012659|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.0248|TWO_SIDED|95.0|1.04|1.91|||Cochran-Mantel-Haenszel|||||1.91|1.04|0.0248
91562131|NCT02367794|183012659|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.4||||0.0308|TWO_SIDED|95.0|1.03|1.9|||Cochran-Mantel-Haenszel|||||1.90|1.03|0.0308
91562132|NCT02367794|183012660|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.408|0.689|||Log Rank|||||0.689|0.408|<.0001
91562133|NCT02367794|183012660|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.64||||0.0007|TWO_SIDED|95.0|0.493|0.831|||Log Rank|||||0.831|0.493|0.0007
91562134|NCT02367794|183012661|SUPERIORITY||Difference in Event Free Rate|0.06||||0.9871|TWO_SIDED|95.0|-7.48|7.61|||Z-test|||Event Free Rate (%) at Year 1||7.61|-7.48|0.9871
91562135|NCT02367794|183012661|SUPERIORITY||Difference in Event Free Rate|5.93||||0.1133|TWO_SIDED|95.0|-1.41|13.26|||Z-test|||Event Free Rate (%) at Year 2||13.26|-1.41|0.1133
91562136|NCT02367794|183012661|SUPERIORITY||Difference in Event Free Rate|-3.97||||0.3072|TWO_SIDED|95.0|-11.6|3.65|||Z-test|||Event Free Rate (%) at Year 1||3.65|-11.60|0.3072
91562137|NCT02367794|183012661|SUPERIORITY||Difference in Event Free Rate|1.21||||0.743|TWO_SIDED|95.0|-6.01|8.42|||Z-test|||Event Free Rate (%) at Year 2||8.42|-6.01|0.7430
91562138|NCT02367794|183012662|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.797||||0.0461|TWO_SIDED|95.0|0.638|0.996|||Log Rank|||||0.996|0.638|0.0461
91562139|NCT02367794|183012662|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.04||||0.7295|TWO_SIDED|95.0|0.834|1.296|||Log Rank|||||1.296|0.834|0.7295
91562140|NCT02367794|183012663|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.828||||0.0942|TWO_SIDED|95.0|0.663|1.033|||Log Rank|||||1.033|0.663|0.0942
91562141|NCT02367794|183012663|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.968||||0.7709|TWO_SIDED|95.0|0.776|1.207|||Log Rank|||||1.207|0.776|0.7709
91562142|NCT02367794|183012665|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.93||||0.4007|TWO_SIDED|95.0|0.784|1.102|||Log Rank|||||1.102|0.784|0.4007
91562143|NCT02033174|183012696|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.05
91562144|NCT04919499|183012767|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0252|STANDARD_ERROR_OF_MEAN|0.0376|||TWO_SIDED|95.0|-0.1048|0.0545|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0545|-0.1048|
91562145|NCT04919499|183012768|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0101|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.0625|0.0422|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0422|-0.0625|
91562146|NCT04919499|183012769|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.0016|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.0504|0.0536|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0536|-0.0504|
91562147|NCT04919499|183012770|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-4.7|5.0|||||"Calculated as \[high-dose BI 765128\] - \[Sham\]~Results were rounded to one decimal place."|||5.0|-4.7|
91562148|NCT01612221|183012772|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||.65
91562149|NCT01612221|183012773|SUPERIORITY|||||||0.76|||||||ANCOVA|||GCLM Biomarker analysis.||||0.76
91562150|NCT01612221|183012773|SUPERIORITY|||||||0.63|||||||ANCOVA|||SLC1A4 Biomarker analysis.||||0.63
91562151|NCT01612221|183012773|SUPERIORITY|||||||0.27|||||||ANCOVA|||SLC7A11 Biomarker analysis.||||0.27
91769106|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-16.7||||0.478|TWO_SIDED|95.0|-37.8|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||4.4|-37.8|0.478
91562152|NCT01857362|183012774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|Ratio of geomectric means|1.0|||||TWO_SIDED|90.0|0.988|1.045|||ANOVA|||||1.045|0.988|
91562153|NCT01857362|183012775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|ratio of geometric means|0.989|||||TWO_SIDED|90.0|0.945|1.034|||ANOVA|||||1.034|0.945|
91562154|NCT01020487|183012803|SUPERIORITY_OR_OTHER||Difference|27.8||||0.045|TWO_SIDED|95.0|7.5|52.8|||Fisher Exact|||Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.||52.8|7.5|0.045
91562155|NCT01020487|183012804|SUPERIORITY_OR_OTHER|||||||0.128|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.128
91562156|NCT01020487|183012805|SUPERIORITY_OR_OTHER||Differenbce|-72.4|||<|0.001|TWO_SIDED|95.0|-108.05|-36.75|||Mixed Models Analysis|||Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-36.75|-108.05|< 0.001
91562157|NCT01020487|183012805|SUPERIORITY_OR_OTHER||Difference|-62.55||||0.006|TWO_SIDED|95.0|-105.6|-19.49|||Mixed Models Analysis|||Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-19.49|-105.60|0.006
91769107|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||27.0|-35.3|1.000
91562158|NCT01020487|183012805|SUPERIORITY_OR_OTHER||Difference|-68.43||||0.032|TWO_SIDED|95.0|-130.39|-6.47|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-6.47|-130.39|0.032
91562159|NCT01020487|183012805|SUPERIORITY_OR_OTHER||Difference|-70.09||||0.043|TWO_SIDED|95.0|-137.82|-2.37|||Mixed Models Analysis|||Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-2.37|-137.82|0.043
91562160|NCT01020487|183012805|SUPERIORITY_OR_OTHER||Difference|-88.52||||0.002|TWO_SIDED|95.0|-142.04|-35.01|||Mixed Models Analysis|||Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-35.01|-142.04|0.002
91562161|NCT01020487|183012806|SUPERIORITY_OR_OTHER|||||||0.327|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.327
91562162|NCT01020487|183012807|SUPERIORITY_OR_OTHER|||||||0.194|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.194
91562163|NCT01020487|183012808|SUPERIORITY_OR_OTHER||Difference|0.14||||0.469|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.53|-0.25|0.469
91562164|NCT01020487|183012808|SUPERIORITY_OR_OTHER||Difference|-0.01||||0.975|TWO_SIDED|95.0|-0.39|0.37|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||0.37|-0.39|0.975
91562165|NCT01020487|183012808|SUPERIORITY_OR_OTHER||Difference|0.12||||0.567|TWO_SIDED|95.0|-0.32|0.56|||Mixed Models Analysis|||Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.56|-0.32|0.567
91562166|NCT01020487|183012808|SUPERIORITY_OR_OTHER||Difference|0.3||||0.462|TWO_SIDED|95.0|-0.53|1.12|||Mixed Models Analysis|||Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||1.12|-0.53|0.462
91562167|NCT01074229|183012819|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Using Dunns test with Bonferroni conrrection for individual comparisons.||||||.05
91562168|NCT01074229|183012819|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|9.0|37.0|||Dunns test|Bonferonni correction||||37|9|.05
91562169|NCT01074229|183012819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.05|TWO_SIDED|95.0|14.0|42.0|||Dunns Test|Bonferroni correction||||42|14|.05
91562170|NCT01074229|183012820|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|With Dunns test and Bonferonni correction.||||||.05
91562171|NCT01074229|183012820|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003|TWO_SIDED|95.0|3.0|15.0|||Dunns test|||||15|3|0.003
91562172|NCT01074229|183012820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.14|TWO_SIDED|95.0|-1.0|12.0|||Dunns test|||||12|-1|0.14
91562173|NCT00237718|183012821|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91562174|NCT00237718|183012822|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
91562175|NCT00901459|183012826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|0.44||0.014|TWO_SIDED|95.0|0.51|2.43||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=14|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (Frequency control)and the corresponding craving change in the 1Hz sfg condition (active).|A pairwise t-test was performed to contrast the active rTMS condition with the frequency control condition.||2.43|0.51|0.014
91562176|NCT00901459|183012826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.4||0.49|TWO_SIDED|95.0|-0.64|1.22|||t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 1Hz sfg condition (active)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the active rTMS condition with the location control condition.||1.22|-0.64|0.49
91769108|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.1|-26.7|0.515
91769109|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-17.9|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||34.6|-17.9|1.000
91769110|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||31.9|-23.6|1.000
91769111|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||71.9|-21.9|0.344
91562177|NCT00901459|183012826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.44||0.09|TWO_SIDED|95.0|0.52|1.39||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (frequency control)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the location control rTMS condition with the frequency control condition.||1.39|0.52|0.09
91562178|NCT04791917|183012841|SUPERIORITY|||||||0.26|||||||ANCOVA|F(1,41) = 1.32, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.26
91562179|NCT04791917|183012842|SUPERIORITY|||||||0.11|||||||ANCOVA|F(1,43) = 2.60, partial eta squared = .06||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.11
91562180|NCT04791917|183012843|SUPERIORITY|||||||0.17|||||||ANCOVA|F(1,42) = 1.95, partial eta squared = .04||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol Pmax including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.17
91562181|NCT04791917|183012844|SUPERIORITY|||||||0.91|||||||ANCOVA|F(1,43)=.01, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol essential value including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.91
91562182|NCT04791917|183012845|SUPERIORITY|||||||0.14|||||||ANCOVA|F(1,41) = 2.24, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.14
91562183|NCT04791917|183012846|SUPERIORITY|||||||0.83|||||||ANCOVA|F(1,41) = .04, partial eta squared = .001||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.83
91562184|NCT04791917|183012847|SUPERIORITY|||||||0.15|||||||ANCOVA|F(1,41) = 2.20, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.15
91562185|NCT04791917|183012848|SUPERIORITY|||||||0.24|||||||ANCOVA|F(1,41) = 1.41, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.24
91562186|NCT04791917|183012849|SUPERIORITY|||||||0.97|||||||ANCOVA|F(1,41) = .001, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.97
91562187|NCT04791917|183012849|SUPERIORITY|||||||0.03|||||||ANCOVA|F(1,41) = 4.86, partial eta squared = .11||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Time X Group interaction.||||.03
91562188|NCT04791917|183012850|SUPERIORITY|||||||0.04|||||||ANCOVA|F(1,42) = 4.66, partial eta squared = .10||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.04
91562189|NCT04791917|183012850|SUPERIORITY||Slope|0.1||||0.26|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the DOMS group.||||.26
91562190|NCT04791917|183012850|SUPERIORITY||Slope|-0.09||||0.22|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the DOMS group.||||.22
91562191|NCT04791917|183012850|SUPERIORITY||Slope|-0.1||||0.27|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the sham DOMS group.||||.27
91562192|NCT04791917|183012850|SUPERIORITY||Slope|0.06||||0.49|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the sham DOMS group.||||.49
91562193|NCT00850993|183012853|OTHER|Pairwise comparison for each Stannsoporfin treatment group versus placebo.|LS Mean Difference|-13.45|||=|0.04|TWO_SIDED|95.0|-26.27|-0.62|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Least-squares means are from an ANCOVA model for adjusted TSB with treatment and gestational age as fixed effects and baseline adjusted TSB as a covariate. TSB is calculated as \[(TSB - Phototherapy(PT) threshold)/ PT threshold \] X 100%.||-0.62|-26.27|=0.040
91562194|NCT00850993|183012853|OTHER||LS Mean Difference|-10.02|||=|0.117|TWO_SIDED|95.0|-22.61|2.58|||ANCOVA|||||2.58|-22.61|=0.117
91562195|NCT00850993|183012853|OTHER||LS Mean Difference|-14.93|||=|0.057|TWO_SIDED|95.0|-30.31|0.44|||ANCOVA|||||0.44|-30.31|=0.057
91562196|NCT00850993|183012854|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.81|||=|0.061|TWO_SIDED|95.0|-3.71|0.09|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.09|-3.71|=0.061
91562197|NCT00850993|183012854|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.34|||=|0.163|TWO_SIDED|95.0|-3.24|0.56|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.56|-3.24|=0.163
91562198|NCT00850993|183012854|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-2.63|||=|0.028|TWO_SIDED|95.0|-4.97|-0.3|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||-0.3|-4.97|=0.028
91562199|NCT03032965|183012860|SUPERIORITY|||||||0.83|||||||Log Rank|Kaplan Meier log rank||||||.83
91562200|NCT03032965|183012861|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.35
91562201|NCT03032965|183012863|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
91562202|NCT01842360|183012896|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
91562203|NCT01842360|183012897|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Poisson|||||||<0.001
91562204|NCT01842360|183012898|SUPERIORITY|||||||0.0094|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean of health care consumption was 17.5±34.7 points in the placebo group versus 9.2±27.9 points in the MV130 group.||||0.0094
91562205|NCT01842360|183012899|SUPERIORITY|||||||0.3917|TWO_SIDED|95.0|||||Log Rank|||||||0.3917
91562206|NCT01842360|183012900|SUPERIORITY|||||||0.0232|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||As for the previous index the number of days with any of these drugs is used.||||0.0232
91562207|NCT01842360|183012901|SUPERIORITY|||||||0.0319|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0319
91562208|NCT01842360|183012902|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
91562209|NCT01842360|183012903|SUPERIORITY|||||||0.0037|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of emergency room visits was 0.37 (±1.15) for the MV130 group and 0.87 (±1.61) for the placebo group.||||0.0037
91562210|NCT01842360|183012904|SUPERIORITY|||||||0.1008|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of medical consultations was 0.08 (±0.31) for the MV130 group and 0.31 (±0.88) for the placebo group.||||0.1008
91562211|NCT01842360|183012905|SUPERIORITY|||||||0.0367|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.0367
91562212|NCT01842360|183012907|SUPERIORITY|||||||0.3234|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3234
91562213|NCT01842360|183012908|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
91562214|NCT04206501|183012914|SUPERIORITY|||||||0.064||||||The rate of change in HF medications (beta-blocker, diuretic, and Sacubitril/Valsartan) was compared betweenICM Guidedand usual care control group using chi-square analysis.|Chi-squared|||Due to the unexpected low enrollment during COVID pandemic, we aimed to primarily focus the limited analysis/description on the primary endpoint and exploratory analysis related to QOL||||0.064
91562215|NCT02006641|183012936|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.51||1|TWO_SIDED|95.0|-1.1|0.92||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.92|-1.10|1.000
91562216|NCT02006641|183012936|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.52||0.2223|TWO_SIDED|95.0|-0.38|1.65||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.65|-0.38|0.2223
91562217|NCT02006641|183012937|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.65||1|TWO_SIDED|95.0|-1.11|1.46||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.46|-1.11|1.000
91562218|NCT02006641|183012937|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.27|1.33||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.33|-1.27|1.000
91769112|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|17.9||||0.429|TWO_SIDED|95.0|-17.8|53.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||53.5|-17.8|0.429
91562219|NCT02006641|183012938|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||1|TWO_SIDED|95.0|-0.23|0.1||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.10|-0.23|1.000
91562220|NCT02006641|183012938|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.12|0.21||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.21|-0.12|1.000
91562221|NCT00872339|183012947|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
91562222|NCT00872339|183012949|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
91562223|NCT02066389|183012960|SUPERIORITY|||||||0.153||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.153
91562224|NCT02066389|183012960|SUPERIORITY|||||||0.018||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.018
91562225|NCT02066389|183012960|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
91562226|NCT02066389|183012960|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
91562227|NCT02066389|183012960|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
91769113|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||25.0|-46.4|1.000
91562228|NCT02066389|183012961|SUPERIORITY|||||||0.034||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.034
91562229|NCT02066389|183012961|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
91562230|NCT02066389|183012961|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.002
91562231|NCT02066389|183012961|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.010
91562232|NCT02066389|183012961|SUPERIORITY|||||||0.012||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.012
91562233|NCT02066389|183012962|SUPERIORITY|||||||0.023||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.023
91562234|NCT02066389|183012962|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
91562235|NCT02066389|183012962|SUPERIORITY|||||||0.145||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.145
91562236|NCT02066389|183012962|SUPERIORITY|||||||0.007||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.007
91562237|NCT02066389|183012962|SUPERIORITY|||||||0.014||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.014
91562238|NCT02066389|183012963|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.005
91562239|NCT02066389|183012963|SUPERIORITY||||||<|0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||<0.001
91562240|NCT02066389|183012963|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.010
91562241|NCT02066389|183012963|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.002
91562242|NCT02066389|183012963|SUPERIORITY|||||||0.024||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.024
91562243|NCT02066389|183012964|SUPERIORITY|||||||0.015||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.015
91562244|NCT02066389|183012964|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
91562245|NCT02066389|183012964|SUPERIORITY|||||||0.029||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.029
91562246|NCT02066389|183012964|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
91562247|NCT02066389|183012964|SUPERIORITY|||||||0.343||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.343
91562248|NCT02066389|183012965|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
91562249|NCT02066389|183012965|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
91562250|NCT02066389|183012965|SUPERIORITY|||||||0.046||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.046
91562251|NCT02066389|183012965|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.005
91562252|NCT02066389|183012965|SUPERIORITY|||||||0.096||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.096
91562253|NCT02066389|183012966|SUPERIORITY|||||||0.269||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.269
91562254|NCT02066389|183012966|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
91562255|NCT02066389|183012966|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
91562256|NCT02066389|183012966|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
91562257|NCT02066389|183012966|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
91562258|NCT03444298|183013072|SUPERIORITY|||||||0.67||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.67
91562259|NCT03444298|183013073|SUPERIORITY|||||||0.43||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.43
91562260|NCT03444298|183013074|SUPERIORITY|||||||0.27||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.27
91562261|NCT03444298|183013075|SUPERIORITY|||||||0.92||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.92
91562262|NCT03444298|183013076|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.99
91562263|NCT03444298|183013076|SUPERIORITY|||||||0.04||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.04
91562264|NCT03444298|183013077|SUPERIORITY|||||||0.98||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.98
91562265|NCT03444298|183013077|SUPERIORITY|||||||0.02||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.02
91562266|NCT03444298|183013078|SUPERIORITY|||||||0.84||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.84
91562267|NCT03444298|183013079|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.59
91562268|NCT03444298|183013080|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.83
91562269|NCT03444298|183013081|SUPERIORITY|||||||0.51||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.51
91562270|NCT03444298|183013082|SUPERIORITY|||||||0.48||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.48
91562271|NCT03444298|183013083|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.01
91562272|NCT03444298|183013084|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.0001
91562273|NCT02158806|183013092|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Cox Proportional Hazard|0.85|STANDARD_ERROR_OF_MEAN|0.146||0.246|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Placebo group = reference group|Placebo group = reference group||1.13|0.64|0.246
91562274|NCT02158806|183013093|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Risk Ratio (RR)|0.88||||0.073|TWO_SIDED|95.0|0.76|1.01|||Chi-squared|||||1.01|0.76|0.073
91562275|NCT02158806|183013094|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.25|TWO_SIDED|95.0|-1.9|0.5||Adjusted for baseline values.|ANCOVA|One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.|Placebo group = reference group.|||0.5|-1.9|0.25
91562276|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|1.1||||0.714|TWO_SIDED|95.0|-5.0|7.2|||Regression, Linear|Adjusted for baseline values||Change in Physical Functioning||7.2|-5.0|0.714
91562277|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|1.4||||0.768|TWO_SIDED|95.0|-8.0|10.8|||Regression, Linear|Adjusted for baseline values||Change in Role Physical||10.8|-8.0|0.768
91562278|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|2.3||||0.449|TWO_SIDED|95.0|-3.7|8.4|||Regression, Linear|Adjusted for baseline values||Change in Bodily Pain||8.4|-3.7|0.449
91562279|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|-0.3||||0.873|TWO_SIDED|95.0|-4.3|3.6|||Regression, Linear|Adjusted for baseline values||Change in General Health||3.6|-4.3|0.873
91562280|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|4.2||||0.057|TWO_SIDED|95.0|-0.1|8.5|||Regression, Linear|Adjusted for baseline values||Change in Vitality||8.5|-0.1|0.057
91562281|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|1.0||||0.756|TWO_SIDED|95.0|-5.1|7.0|||Regression, Linear|Adjusted for baseline values||Change in Social Functioning||7.0|-5.1|0.756
91562282|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|3.7||||0.4|TWO_SIDED|95.0|-4.9|12.3|||Regression, Linear|Adjusted for baseline values||Change in Role Emotional||12.3|-4.9|0.400
91562283|NCT02158806|183013095|SUPERIORITY||Mean Difference (Net)|-2.3||||0.236|TWO_SIDED|95.0|-6.2|1.5|||Regression, Linear|Adjusted for baseline values||Change in Mental Health||1.5|-6.2|0.236
91562284|NCT02158806|183013096|SUPERIORITY||Mean Difference (Net)|3.4||||0.156|TWO_SIDED|95.0|-1.3|8.0||Adjusted for baseline values|Regression, Linear|||||8.0|-1.3|0.156
91562285|NCT02158806|183013097|SUPERIORITY||Mean Difference (Net)|-1.5||||0.438|TWO_SIDED|95.0|-5.2|2.2|||Regression, Linear|Adjusted for baseline values||Change in social function||2.2|-5.2|0.438
91562286|NCT02158806|183013097|SUPERIORITY||Mean Difference (Net)|-1.3||||0.408|TWO_SIDED|95.0|-4.5|1.9|||Regression, Linear|Adjusted for baseline values||Change in domestic activities||1.9|-4.5|0.408
91562287|NCT02158806|183013097|SUPERIORITY||Mean Difference (Net)|-1.3||||0.568|TWO_SIDED|95.0|-5.6|3.1|||Regression, Linear|Adjusted for baseline values||Change in cosmesis||3.1|-5.6|0.568
91562288|NCT02158806|183013097|SUPERIORITY||Mean Difference (Net)|-3.0||||0.257|TWO_SIDED|95.0|-8.1|2.2|||Regression, Linear|Adjusted for baseline values||Change in emotional status||2.2|-8.1|0.257
91562289|NCT02158806|183013097|SUPERIORITY||Mean Difference (Net)|-1.9||||0.273|TWO_SIDED|95.0|-5.2|1.5|||Regression, Linear|Adjusted for baseline values||||1.5|-5.2|0.273
91562290|NCT02158806|183013098|SUPERIORITY||Risk Ratio (RR)|1.01||||0.917|TWO_SIDED|95.0|0.87|1.17|||Chi-squared|||||1.17|0.87|0.917
91769114|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-40.4|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||57.1|-40.4|1.000
91769115|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|8.3||||0.671|TWO_SIDED|95.0|-29.9|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||46.6|-29.9|0.671
91769116|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-13.1||||0.656|TWO_SIDED|95.0|-56.7|30.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||30.5|-56.7|0.656
91769117|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||64.7|-31.4|0.627
91769118|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|9.5||||0.701|TWO_SIDED|95.0|-27.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||46.7|-27.7|0.701
91769119|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-19.0||||0.603|TWO_SIDED|95.0|-56.2|18.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||18.1|-56.2|0.603
91769120|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||64.7|-31.4|0.627
91769121|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-34.2|39.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||39.0|-34.2|1.000
91562291|NCT02158806|183013099|SUPERIORITY||Incidence Rate Ratio|1.1||||0.71|TWO_SIDED|95.0|0.7|1.7|||IRR test statistic|Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.||||1.7|0.7|0.71
91769122|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-4.8||||1|TWO_SIDED|95.0|-47.6|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||38.0|-47.6|1.000
91769123|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||71.9|-21.9|0.344
91769124|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|25.0||||0.248|TWO_SIDED|95.0|-10.9|60.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||60.9|-10.9|0.248
91769125|NCT02365649|183425731|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||25.0|-46.4|1.000
91769126|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|1.000
91769127|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||70.8|-20.8|0.608
91562292|NCT01898299|183013101|SUPERIORITY||Cohen's d effectsize|0.48||||0.036|TWO_SIDED||||||ANCOVA|Control for Chlopromazine equivalents||||||0.036
91562293|NCT02340806|183013102|SUPERIORITY|||||||0.67|||||||Chi-squared, Corrected|||||||.67
91562294|NCT02340806|183013103|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
91562295|NCT02340806|183013104|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||.21
91562296|NCT02340806|183013105|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
91562297|NCT02340806|183013106|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||.66
91562298|NCT02340806|183013108|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||.92
91562299|NCT02340806|183013109|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||.58
91562300|NCT02340806|183013110|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||.67
91562301|NCT02340806|183013111|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||.99
91562302|NCT02340806|183013112|SUPERIORITY|||||||0.37|||||||Kruskal-Wallis|||||||.37
91562303|NCT02591056|183013115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|t=+7.45; df=26||||||<0.0001
91562304|NCT01159600|183013116|SUPERIORITY_OR_OTHER||Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.17|-1.08||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.08|-2.17|<0.0001
91562305|NCT01159600|183013116|SUPERIORITY_OR_OTHER||Mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.56|-1.46||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.46|-2.56|<0.0001
91562306|NCT01159600|183013116|SUPERIORITY_OR_OTHER||Mean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.25|-1.28||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.28|-2.25|<0.0001
91562307|NCT01159600|183013116|SUPERIORITY_OR_OTHER||Mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.48|-1.5||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.50|-2.48|<0.0001
91562308|NCT01159600|183013117|SUPERIORITY_OR_OTHER||Mean difference|-7.65|STANDARD_ERROR_OF_MEAN|2.74||0.0055|TWO_SIDED|97.5|-13.81|-1.48||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-1.48|-13.81|0.0055
91769128|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|0.487
91769129|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|20.0||||0.25|TWO_SIDED|95.0|-15.1|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||55.1|-15.1|0.250
91769130|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|8.3||||0.444|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||24.0|-7.3|0.444
91769131|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||31.6|-9.4|0.375
91769132|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-31.1|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||37.8|-31.1|1.000
91769133|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|22.4||||0.215|TWO_SIDED|95.0|-8.0|52.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||52.8|-8.0|0.215
91769134|NCT02365649|183425732|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||27.8|-29.5|1.000
91769135|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-15.0||||0.671|TWO_SIDED|95.0|-55.5|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||25.5|-55.5|0.671
91769136|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|10.0||||0.718|TWO_SIDED|95.0|-19.8|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||39.8|-19.8|0.718
91769137|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-15.0||||0.461|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||22.4|-52.4|0.461
91769138|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-50.0||||0.03|TWO_SIDED|95.0|-85.5|-14.5||Statistically significant at 0.05 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||-14.5|-85.5|0.030
91769139|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-12.5||||0.483|TWO_SIDED|95.0|-42.9|17.9|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||17.9|-42.9|0.483
91769140|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-15.0||||0.431|TWO_SIDED|95.0|-50.8|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||20.8|-50.8|0.431
91769141|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-31.1|41.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||41.1|-31.1|1.000
91769142|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-7.5||||0.635|TWO_SIDED|95.0|-38.6|23.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||23.6|-38.6|0.635
91513984|NCT00489970|182899991|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response|-4.76|||||TWO_SIDED|97.5|-14.53|3.18|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||3.18|-14.53|
91562309|NCT01159600|183013117|SUPERIORITY_OR_OTHER||Mean difference|-12.37|STANDARD_ERROR_OF_MEAN|2.75|<|0.0001|TWO_SIDED|97.5|-18.55|-6.19||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.19|-18.55|<0.0001
91562310|NCT01159600|183013117|SUPERIORITY_OR_OTHER||Mean difference|-10.02|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|97.5|-15.72|-4.32||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-4.32|-15.72|<0.0001
91562311|NCT01159600|183013117|SUPERIORITY_OR_OTHER||Mean difference|-13.06|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|97.5|-19.15|-6.98||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.98|-19.15|<0.0001
91562312|NCT01159600|183013118|SUPERIORITY_OR_OTHER||Mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.72|-0.42||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.42|-0.72|<0.0001
91562313|NCT01159600|183013118|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.48||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.48|-0.79|<0.0001
91562314|NCT01159600|183013118|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.49||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.49|-0.79|<0.0001
91562315|NCT01159600|183013118|SUPERIORITY_OR_OTHER||Mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.74|-0.44||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.44|-0.74|<0.0001
91562316|NCT00760877|183013120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.096||||0.1083|TWO_SIDED|95.0|0.766|5.738|||Cochran-Mantel-Haenszel|||||5.738|0.766|0.1083
91562317|NCT02878590|183013128|SUPERIORITY|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
91769143|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-40.0||||0.056|TWO_SIDED|95.0|-74.8|-5.2||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-5.2|-74.8|0.056
91513985|NCT02212028|182900016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.0||||0.022|TWO_SIDED|95.0|10.0|126.0|||ANOVA|||||126|10|0.022
91513986|NCT02212028|182900017|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
91513987|NCT02646423|182900026|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.84|1.05||||||||1.05|0.84|
91513988|NCT02646423|182900027|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.86|1.16||||||||1.16|0.86|
91513989|NCT02646423|182900028|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.16|0.19||||||||0.19|-0.16|
91513990|NCT02646423|182900029|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.81|1.05||||||||1.05|-1.81|
91513991|NCT02646423|182900030|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-1.96|1.27||||||||1.27|-1.96|
91513992|NCT02646423|182900031|SUPERIORITY||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|-0.94|1.66||||||||1.66|-0.94|
91513993|NCT02646423|182900032|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.03||||||||0.03|-0.09|
91513994|NCT02646423|182900033|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.51||||||||1.51|0.46|
91513995|NCT02646423|182900034|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.64|1.56||||||||1.56|0.64|
91513996|NCT02646423|182900035|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.64|2.81||||||||2.81|0.64|
91513997|NCT02646423|182900036|SUPERIORITY||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.6|6.62||||||||6.62|0.60|
91513998|NCT02646423|182900037|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.72|1.35||||||||1.35|0.72|
91513999|NCT02646423|182900038|SUPERIORITY||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.86|1.48||||||||1.48|0.86|
91514000|NCT04564833|182900041|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91514001|NCT04564833|182900041|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91514002|NCT04564833|182900042|SUPERIORITY|||||||0.3954|||||||ANCOVA|||||||0.3954
91514003|NCT04564833|182900042|SUPERIORITY|||||||0.0682|||||||ANCOVA|||||||0.0682
91514004|NCT04564833|182900043|SUPERIORITY|||||||0.6755|||||||Fisher Exact|||||||0.6755
91514005|NCT04564833|182900043|SUPERIORITY|||||||0.6758|||||||Fisher Exact|||||||0.6758
91514006|NCT04564833|182900044|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
91514007|NCT04564833|182900044|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
91514008|NCT00321919|182900062|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.778976||||0.2036|TWO_SIDED|95.0|0.53|1.14|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.||1.14|0.53|0.2036
91514009|NCT00321919|182900063|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.744575||||0.4833|TWO_SIDED|95.0|0.33|1.7|||Regression, Cox||The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.70|0.33|0.4833
91514010|NCT00321919|182900065|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.658259||||0.1391|TWO_SIDED|95.0|0.38|1.15|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.|||1.15|0.38|0.1391
91514011|NCT00321919|182900068|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.804594||||0.4985|TWO_SIDED|95.0|0.43|1.51|||Regression, Cox||The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group|||1.51|0.43|0.4985
91514012|NCT00321919|182900070|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82046||||0.3419|TWO_SIDED|95.0|0.55|1.23|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.23|0.55|0.3419
91514013|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.||||0.0029
91514014|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2||||0.0081
91514015|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1||||0.0005
91514016|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2||||0.0965
91514017|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1||||0.0004
91514018|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.9864|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2||||0.9864
91514019|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1||||0.0097
91514020|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2||||0.1670
91514021|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1||||0.0058
91514022|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.1455|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2||||0.1455
91769144|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.5|-47.5|1.000
91769145|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|17.5||||0.296|TWO_SIDED|95.0|-14.7|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||49.7|-14.7|0.296
91769146|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.4|-42.4|1.000
91769147|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-45.9|35.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||35.9|-45.9|1.000
91769148|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||45.2|-17.7|0.400
91769149|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
91769150|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.6|-12.8|0.259
91769151|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.5||||0.31|TWO_SIDED|95.0|-30.6|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||9.7|-30.6|0.310
91769152|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-19.4||||0.097|TWO_SIDED|95.0|-38.8|-0.1||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||-0.1|-38.8|0.097
91769153|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|24.4||||0.181|TWO_SIDED|95.0|-8.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||57.2|-8.5|0.181
91769154|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|2.0||||0.826|TWO_SIDED|95.0|-15.9|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||20.0|-15.9|0.826
91514023|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1||||0.0009
91562318|NCT02169089|183013175|SUPERIORITY||Median Difference (Final Values)|-7.78||||0.0293|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0293
91514024|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2||||0.0123
91514025|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1||||0.3155
91514026|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.7076|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2||||0.7076
91514027|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.1291|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1||||0.1291
91562319|NCT02169089|183013176|SUPERIORITY||Median Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -3.5 and 2.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||<0.0001
91562320|NCT02169089|183013177|SUPERIORITY||Median Difference (Final Values)|-40.7||||0.0189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -10.3 and 17.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.0189
91562321|NCT02169089|183013178|SUPERIORITY||Median Difference (Final Values)|-7.5||||0.1276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -5.95 and 2 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.1276
91562322|NCT05361304|183013186|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.04|0.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under HLLC.||0.000|-0.040|
91562323|NCT05361304|183013186|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.03|0.02|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC.||0.020|-0.030|
91562324|NCT05361304|183013187|NON_INFERIORITY||Least square Mean (LSM) Difference|0.27|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.46|1.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology.||1.010|-0.460|
91769155|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||16.1|-21.2|1.000
91562325|NCT05361304|183013188|NON_INFERIORITY||LSM Difference|4.0|STANDARD_ERROR_OF_MEAN|4.06|||TWO_SIDED|95.0|-4.1|12.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||12.0|-4.1|
91562326|NCT05361304|183013189|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the confidence interval of the mean difference between Senofilcon A contact lenses made with a novel manufacturing technology and Senofilcon A contact lenses made with the current manufacturing technology is greater than -5.|LSM Differences|-0.3|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.1|6.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||6.5|-7.1|
91562327|NCT03320941|183013190|OTHER|Dose Finding|Mean Difference (Net)|-1.99|||||TWO_SIDED|95.0|-2.92|-0.21||||||||-0.21|-2.92|
91562328|NCT03320941|183013190|OTHER|Dose Finding|Mean Difference (Net)|-3.0|||||TWO_SIDED|95.0|-4.15|-1.7||||||||-1.70|-4.15|
91562329|NCT03320941|183013190|OTHER|Dose Finding|Mean Difference (Net)|-3.54|||||TWO_SIDED|95.0|-4.54|-2.26||||||||-2.26|-4.54|
91562330|NCT03320941|183013190|OTHER|Dose Finding|Mean Difference (Net)|-3.91|||||TWO_SIDED|95.0|-5.01|-2.77||||||||-2.77|-5.01|
91562331|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|2.299||||0.39|TWO_SIDED|95.0|0.344|15.35|||Regression, Logistic|||\>= 3% Percent decrease in body weight||15.350|0.344|0.390
91562332|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|15.78||||0.002|TWO_SIDED|95.0|2.844|87.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight||87.552|2.844|0.002
91562333|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|12.708||||0.002|TWO_SIDED|95.0|2.511|64.32|||Regression, Logistic|||\>= 3% Percent decrease in body weight||64.320|2.511|0.002
91562334|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|16.813|||<|0.001|TWO_SIDED|95.0|3.362|84.085|||Regression, Logistic|||\>= 3% Percent decrease in body weight||84.085|3.362|<0.001
91562335|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|1.697||||0.727|TWO_SIDED|95.0|0.087|33.006|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||33.006|0.087|0.727
91562336|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|28.26||||0.012|TWO_SIDED|95.0|2.066|386.473|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||386.473|2.066|0.012
91562337|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|10.333||||0.059|TWO_SIDED|95.0|0.914|116.82|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||116.820|0.914|0.059
91562338|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|9.456||||0.062|TWO_SIDED|95.0|0.891|100.292|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||100.292|0.891|0.062
91562339|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|3.59||||0.336|TWO_SIDED|95.0|0.265|48.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||48.552|0.265|0.336
91562340|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio, log|9.112||||0.075|TWO_SIDED|95.0|0.799|103.872|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||103.872|0.799|0.075
91562341|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|29.312||||0.006|TWO_SIDED|95.0|2.665|322.412|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||322.412|2.665|0.006
91562342|NCT03320941|183013191|OTHER|Dose Finding|Odds Ratio (OR)|37.949||||0.003|TWO_SIDED|95.0|3.477|414.232|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||414.232|3.477|0.003
91562343|NCT03320941|183013192|OTHER|Dose Finding|Median Difference (Final Values)|-1.84|||||TWO_SIDED|95.0|-3.56|-0.19||||||Dysglycemic||-0.19|-3.56|
91562344|NCT03320941|183013192|OTHER|Dose Finding|Mean Difference (Final Values)|-2.98|||||TWO_SIDED|95.0|-4.56|-1.46||||||Dysglycemic||-1.46|-4.56|
91769156|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|14.4||||0.369|TWO_SIDED|95.0|-16.7|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||45.4|-16.7|0.369
91769157|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-0.9||||1|TWO_SIDED|95.0|-18.2|16.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.4|-18.2|1.000
91769158|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.1|-21.2|1.000
91562345|NCT03320941|183013192|OTHER|Dose Finding|Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-4.71|-1.82||||||Dysglycemic||-1.82|-4.71|
91562346|NCT03320941|183013192|OTHER|Dose Finding|Mean Difference (Final Values)|-3.51|||||TWO_SIDED|95.0|-4.93|-1.74||||||Dysglycemic||-1.74|-4.93|
91562347|NCT03320941|183013192|OTHER|Dose Finding|Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.12|-0.15||||||T2DM||-0.15|-3.12|
91769159|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|11.3||||0.66|TWO_SIDED|95.0|-20.2|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||42.7|-20.2|0.660
91769160|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-1.1||||0.908|TWO_SIDED|95.0|-19.7|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||17.5|-19.7|0.908
91769161|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.1||||0.446|TWO_SIDED|95.0|-27.8|7.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||7.7|-27.8|0.446
91562348|NCT03320941|183013192|OTHER|Dose Finding|Mean Difference (Final Values)|-2.88|||||TWO_SIDED|95.0|-4.37|-0.61||||||T2DM||-0.61|-4.37|
91562349|NCT03320941|183013192|OTHER|Dose Finding|Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-5.2|-1.52||||||T2DM||-1.52|-5.20|
91562350|NCT03320941|183013192|OTHER|Dose Finding|Median Difference (Final Values)|-4.37|||||TWO_SIDED|95.0|-5.93|-2.79||||||T2DM||-2.79|-5.93|
91562351|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.011||0.278|TWO_SIDED|95.0|-3.104|0.9|||ANCOVA|||Overall Study||0.900|-3.104|0.278
91562352|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|1.013||0.216|TWO_SIDED|95.0|-3.265|0.747|||ANCOVA|||Overall Study||0.747|-3.265|0.216
91562353|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.902||0.158|TWO_SIDED|95.0|-3.069|0.504|||ANCOVA|||Overall Study||0.504|-3.069|0.158
91562354|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.89||0.053|TWO_SIDED|95.0|-3.401|0.022|||ANCOVA|||Overall Study||0.022|-3.401|0.053
91562355|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-2.36|STANDARD_ERROR_OF_MEAN|1.534||0.13|TWO_SIDED|95.0|-5.444|0.717|||ANCOVA|||Dysglycemic||0.717|-5.444|0.130
91562356|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-4.08|STANDARD_ERROR_OF_MEAN|1.534||0.011|TWO_SIDED|95.0|-7.156|-0.994|||ANCOVA|||Dysglycemic||-0.994|-7.156|0.011
91769162|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|20.6||||0.135|TWO_SIDED|95.0|-9.5|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.8|-9.5|0.135
91562357|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.325||0.215|TWO_SIDED|95.0|-4.322|0.996|||ANCOVA|||Dysglycemic||0.996|-4.322|0.215
91562358|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|1.346||0.184|TWO_SIDED|95.0|-4.515|0.888|||ANCOVA|||Dysglycemic||0.888|-4.515|0.184
91562359|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|1.292||0.982|TWO_SIDED|95.0|-2.611|2.552|||ANCOVA|||T2DM||2.552|-2.611|0.982
91769163|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|11.2||||0.306|TWO_SIDED|95.0|-5.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||28.1|-5.7|0.306
91769164|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||20.7|-13.4|0.686
91769165|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||35.2|-25.4|0.754
91769166|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-7.7||||0.548|TWO_SIDED|95.0|-32.6|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||17.3|-32.6|0.548
91769167|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-22.5||||0.12|TWO_SIDED|95.0|-50.1|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||5.0|-50.1|0.120
91769168|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-13.4||||0.403|TWO_SIDED|95.0|-44.5|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.7|-44.5|0.403
91769169|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-8.0||||0.533|TWO_SIDED|95.0|-33.0|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.0|-33.0|0.533
91769170|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-8.9||||0.539|TWO_SIDED|95.0|-37.2|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||19.4|-37.2|0.539
91769171|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||35.2|-25.4|0.754
91769172|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-14.5||||0.256|TWO_SIDED|95.0|-39.4|10.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||10.3|-39.4|0.256
91562360|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.304||0.544|TWO_SIDED|95.0|-1.809|3.401|||ANCOVA|||T2DM||3.401|-1.809|0.544
91562361|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.188||0.552|TWO_SIDED|95.0|-3.084|1.663|||ANCOVA|||T2DM||1.663|-3.084|0.552
91769173|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-27.8||||0.055|TWO_SIDED|95.0|-54.7|-0.8||Statistically significant at 0.1 level.|Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||-0.8|-54.7|0.055
91769174|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|2.2||||0.887|TWO_SIDED|95.0|-28.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||33.2|-28.8|0.887
91769175|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.4|-10.3|0.256
91769176|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||17.9|-36.0|0.518
91562362|NCT03320941|183013193|OTHER|Dose Finding|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|1.139||0.143|TWO_SIDED|95.0|-3.964|0.588|||ANCOVA|||T2DM||0.588|-3.964|0.143
91562363|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.086||0.018|TWO_SIDED|95.0|-0.376|-0.035|||ANCOVA|||Overall Study||-0.035|-0.376|0.018
91562364|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.0863||0.002|TWO_SIDED|95.0|-0.447|-0.105|||ANCOVA|||Overall Study||-0.105|-0.447|0.002
91562365|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|95.0|-0.437|-0.136|||ANCOVA|||Overall Study||-0.136|-0.437|<0.001
91562366|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.0747|<|0.001|TWO_SIDED|95.0|-0.486|-0.19|||ANCOVA|||Overall Study||-0.190|-0.486|<0.001
91562367|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.089|STANDARD_ERROR_OF_MEAN|0.0775||0.258|TWO_SIDED|95.0|-0.245|0.067|||ANCOVA|||Dysglycemic||0.067|-0.245|0.258
91562368|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.134|STANDARD_ERROR_OF_MEAN|0.0774||0.088|TWO_SIDED|95.0|-0.29|0.021|||ANCOVA|||Dysglycemic||0.021|-0.290|0.088
91562369|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.0673||0.035|TWO_SIDED|95.0|-0.282|-0.011|||ANCOVA|||Dysglycemic||-0.011|-0.282|0.035
91562370|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.0673||0.1|TWO_SIDED|95.0|-0.248|0.022|||ANCOVA|||Dysglycemic||0.022|-0.248|0.100
91562371|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.1399||0.029|TWO_SIDED|95.0|-0.592|-0.033|||ANCOVA|||T2DM||-0.033|-0.592|0.029
91562372|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.399|STANDARD_ERROR_OF_MEAN|0.1411||0.006|TWO_SIDED|95.0|-0.681|-0.117|||ANCOVA|||T2DM||-0.117|-0.681|0.006
91769177|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|6.3||||0.695|TWO_SIDED|95.0|-25.1|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||37.6|-25.1|0.695
91769178|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|11.4||||0.373|TWO_SIDED|95.0|-13.5|36.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||36.4|-13.5|0.373
91769179|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-6.9||||0.628|TWO_SIDED|95.0|-34.6|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||20.8|-34.6|0.628
91769180|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|1.000
91769181|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||20.9|-22.4|1.000
91769182|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|0.251
91769183|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|1.000
91769184|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||17.7|-18.7|1.000
91769185|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|0.501
91769186|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||22.1|-3.0|0.488
91562373|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.409|STANDARD_ERROR_OF_MEAN|0.1253||0.002|TWO_SIDED|95.0|-0.66|-0.159|||ANCOVA|||T2DM||-0.159|-0.660|0.002
91562374|NCT03320941|183013194|OTHER|Dose Finding|Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.1217|<|0.001|TWO_SIDED|95.0|-0.769|-0.282|||ANCOVA|||T2DM||-0.282|-0.769|<0.001
91562375|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.2094||0.408|TWO_SIDED|95.0|-0.589|0.241|||ANCOVA|||Overall Study||0.241|-0.589|0.408
91562376|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.505|STANDARD_ERROR_OF_MEAN|0.2115||0.018|TWO_SIDED|95.0|-0.924|-0.087|||ANCOVA|||Overall Study||-0.087|-0.924|0.018
91562377|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.587|STANDARD_ERROR_OF_MEAN|0.1866||0.002|TWO_SIDED|95.0|-0.956|-0.217|||ANCOVA|||Overall Study||-0.217|-0.956|0.002
91562378|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.1831|<|0.001|TWO_SIDED|95.0|-1.188|-0.463|||ANCOVA|||Overall Study||-0.463|-1.188|<0.001
91562379|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.2054||0.293|TWO_SIDED|95.0|-0.194|0.631|||ANCOVA|||Dysglycemic||0.631|-0.194|0.293
91562380|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2068||0.665|TWO_SIDED|95.0|-0.325|0.506|||ANCOVA|||Dysglycemic||0.506|-0.325|0.665
91562381|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.1791||0.803|TWO_SIDED|95.0|-0.405|0.315|||ANCOVA|||Dysglycemic||0.315|-0.405|0.803
91562382|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.1787||0.159|TWO_SIDED|95.0|-0.615|0.103|||ANCOVA|||Dysglycemic||0.103|-0.615|0.159
91562383|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-0.527|STANDARD_ERROR_OF_MEAN|0.3249||0.11|TWO_SIDED|95.0|-1.176|0.122|||ANCOVA|||T2DM||0.122|-1.176|0.110
91562384|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-1.032|STANDARD_ERROR_OF_MEAN|0.3296||0.003|TWO_SIDED|95.0|-1.691|-0.373|||ANCOVA|||T2DM||-0.373|-1.691|0.003
91562385|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-1.065|STANDARD_ERROR_OF_MEAN|0.2946|<|0.001|TWO_SIDED|95.0|-1.654|-0.476|||ANCOVA|||T2DM||-0.476|-1.654|<0.001
91562386|NCT03320941|183013195|OTHER|Dose Finding|Mean Difference (Final Values)|-1.298|STANDARD_ERROR_OF_MEAN|0.2855|<|0.001|TWO_SIDED|95.0|-1.869|-0.728|||ANCOVA|||T2DM||-0.728|-1.869|<0.001
91514028|NCT00321919|182900077|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2||||0.5528
91562387|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|2.707||0.865|TWO_SIDED|95.0|-4.898|5.822|||ANCOVA|||Overall Study||5.822|-4.898|0.865
91562388|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.765||0.931|TWO_SIDED|95.0|-5.235|5.716|||ANCOVA|||Overall Study||5.716|-5.235|0.931
91562389|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.433||0.682|TWO_SIDED|95.0|-5.817|3.82|||ANCOVA|||Overall Study||3.820|-5.817|0.682
91562390|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.387||0.508|TWO_SIDED|95.0|-6.312|3.142|||ANCOVA|||Overall Study||3.142|-6.312|0.508
91562391|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|4.206||0.757|TWO_SIDED|95.0|-7.138|9.749|||ANCOVA|||Dysglycemic||9.749|-7.138|0.757
91562392|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|4.267||0.999|TWO_SIDED|95.0|-8.571|8.563|||ANCOVA|||Dysglycemic||8.563|-8.571|0.999
91562393|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|3.668||0.342|TWO_SIDED|95.0|-3.848|10.88|||ANCOVA|||Dysglycemic||10.880|-3.848|0.342
91562394|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|3.673||0.43|TWO_SIDED|95.0|-4.454|10.292|||ANCOVA|||Dysglycemic||10.292|-4.454|0.430
91562395|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.461||0.909|TWO_SIDED|95.0|-7.312|6.52|||ANCOVA|||T2DM||6.520|-7.312|0.909
91562396|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|3.563||0.821|TWO_SIDED|95.0|-6.311|7.93|||ANCOVA|||T2DM||7.930|-6.311|0.821
91562397|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.19||0.132|TWO_SIDED|95.0|-11.24|1.508|||ANCOVA|||T2DM||1.508|-11.240|0.132
91562398|NCT03320941|183013196|OTHER|Dose Finding|Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.07||0.093|TWO_SIDED|95.0|-11.367|0.905|||ANCOVA|||T2DM||0.905|-11.367|0.093
91514029|NCT00996996|182900087|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|90.0|100.0|||||The estimated value represents the percentage of participants with a confirmed response.|||100|90|
91514030|NCT00996996|182900088|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|||||TWO_SIDED|95.0|94.0|100.0|||||The estimated value represents the percentage of participants with a response.|||100|94|
91514031|NCT00996996|182900089|SUPERIORITY_OR_OTHER||Percentage of participants|70.0|||||TWO_SIDED|95.0|59.0|80.0|||||The estimated value represents the percentage of participants with a confirmed CR.|||80|59|
91514032|NCT00996996|182900089|SUPERIORITY_OR_OTHER||Percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|6.0|||||The estimated value represents the percentage of participants with a confirmed CCR.|||6|0|
91514033|NCT00996996|182900089|SUPERIORITY_OR_OTHER||Percentage of participants|75.0|||||TWO_SIDED|95.0|65.0|85.0|||||The estimated value represents the percentage of participants with confirmed CR + confirmed CCR.|||85|65|
91514034|NCT00996996|182900089|SUPERIORITY_OR_OTHER||Percentage of participants|17.0|||||TWO_SIDED|95.0|9.0|26.0|||||The estimated value represents the percentage of participants with a confirmed PR.|||26|9|
91562399|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|2.013||0.769|TWO_SIDED|95.0|-4.579|3.393|||ANCOVA|||Overall Study||3.393|-4.579|0.769
91562400|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.043||0.839|TWO_SIDED|95.0|-4.462|3.63|||ANCOVA|||Overall Study||3.630|-4.462|0.839
91562401|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.807||0.496|TWO_SIDED|95.0|-4.811|2.345|||ANCOVA|||Overall Study||2.345|-4.811|0.496
91562402|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.774||0.237|TWO_SIDED|95.0|-5.622|1.402|||ANCOVA|||Overall Study||1.402|-5.622|0.237
91562403|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|3.2||0.758|TWO_SIDED|95.0|-5.435|7.415|||ANCOVA|||Dysglycemic||7.415|-5.435|0.758
91562404|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|3.23||0.978|TWO_SIDED|95.0|-6.574|6.397|||ANCOVA|||Dysglycemic||6.397|-6.574|0.978
91562405|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|2.79||0.512|TWO_SIDED|95.0|-3.758|7.444|||ANCOVA|||Dysglycemic||7.444|-3.758|0.512
91562406|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.792||0.985|TWO_SIDED|95.0|-5.552|5.657|||ANCOVA|||Dysglycemic||5.657|-5.552|0.985
91562407|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.599||0.428|TWO_SIDED|95.0|-7.268|3.121|||ANCOVA|||T2DM||3.121|-7.268|0.428
91769187|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
91769188|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.0||||0.232|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.232
91769189|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.501
91514035|NCT00996996|182900090|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|64.0|84.0|||||The estimated value represents the percentage of participants with a CR.|||84|64|
91514036|NCT00996996|182900090|SUPERIORITY_OR_OTHER||Percentage of participants|4.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with a CCR.|||8|0|
91514037|NCT00996996|182900090|SUPERIORITY_OR_OTHER||Percentage of participants|78.0|||||TWO_SIDED|95.0|68.0|87.0|||||The estimated value represents the percentage of participants with a CR + CCR.|||87|68|
91562408|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.669||0.846|TWO_SIDED|95.0|-5.853|4.812|||ANCOVA|||T2DM||4.812|-5.853|0.846
91562409|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.388||0.095|TWO_SIDED|95.0|-8.825|0.721|||ANCOVA|||T2DM||0.721|-8.825|0.095
91562410|NCT03320941|183013197|OTHER|Dose Finding|Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.31||0.089|TWO_SIDED|95.0|-8.61|0.623|||ANCOVA|||T2DM||0.623|-8.610|0.089
91562411|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-15.561|STANDARD_ERROR_OF_MEAN|21.4808||0.47|TWO_SIDED|95.0|-58.106|26.985|||ANCOVA|||Overall Study||26.985|-58.106|0.470
91562412|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-6.343|STANDARD_ERROR_OF_MEAN|21.6316||0.77|TWO_SIDED|95.0|-49.187|36.501|||ANCOVA|||Overall Study||36.501|-49.187|0.770
91562413|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|26.527|STANDARD_ERROR_OF_MEAN|19.1803||0.169|TWO_SIDED|95.0|-11.462|64.516|||ANCOVA|||Overall Study||64.516|-11.462|0.169
91562414|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-12.094|STANDARD_ERROR_OF_MEAN|18.8076||0.521|TWO_SIDED|95.0|-49.345|25.157|||ANCOVA|||Overall Study||25.157|-49.345|0.521
91562415|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-22.115|STANDARD_ERROR_OF_MEAN|38.7858||0.571|TWO_SIDED|95.0|-100.058|55.828|||ANCOVA|||Dysglycemic||55.828|-100.058|0.571
91562416|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-22.948|STANDARD_ERROR_OF_MEAN|39.4994||0.564|TWO_SIDED|95.0|-102.325|56.429|||ANCOVA|||Dysglycemic||56.429|-102.325|0.564
91562417|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|31.322|STANDARD_ERROR_OF_MEAN|33.855||0.359|TWO_SIDED|95.0|-36.712|99.356|||ANCOVA|||Dysglycemic||99.356|-36.712|0.359
91562418|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-6.901|STANDARD_ERROR_OF_MEAN|34.4309||0.842|TWO_SIDED|95.0|-76.093|62.29|||ANCOVA|||Dysglycemic||62.290|-76.093|0.842
91562419|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-12.79|STANDARD_ERROR_OF_MEAN|24.3259||0.601|TWO_SIDED|95.0|-61.417|35.836|||ANCOVA|||T2DM||35.836|-61.417|0.601
91562420|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|9.302|STANDARD_ERROR_OF_MEAN|24.422||0.705|TWO_SIDED|95.0|-39.517|58.121|||ANCOVA|||T2DM||58.121|-39.517|0.705
91562421|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|20.94|STANDARD_ERROR_OF_MEAN|22.0444||0.346|TWO_SIDED|95.0|-23.126|65.007|||ANCOVA|||T2DM||65.007|-23.126|0.346
91562422|NCT03320941|183013198|OTHER|Dose Finding|Mean Difference (Final Values)|-13.863|STANDARD_ERROR_OF_MEAN|21.2205||0.516|TWO_SIDED|95.0|-56.283|28.556|||ANCOVA|||T2DM||28.556|-56.283|0.516
91562423|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|0.955|STANDARD_ERROR_OF_MEAN|3.605||0.792|TWO_SIDED|95.0|-6.185|8.095|||ANCOVA|||Overall Study||8.095|-6.185|0.792
91562424|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|-0.739|STANDARD_ERROR_OF_MEAN|3.7167||0.843|TWO_SIDED|95.0|-8.1|6.623|||ANCOVA|||Overall Study||6.623|-8.100|0.843
91562425|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|3.128|STANDARD_ERROR_OF_MEAN|3.2564||0.339|TWO_SIDED|95.0|-3.322|9.578|||ANCOVA|||Overall Study||9.578|-3.322|0.339
91562426|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|2.546|STANDARD_ERROR_OF_MEAN|3.1859||0.426|TWO_SIDED|95.0|-3.764|8.856|||ANCOVA|||Overall Study||8.856|-3.764|0.426
91562427|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|5.8734||0.932|TWO_SIDED|95.0|-11.299|12.307|||ANCOVA|||Dysglycemic||12.307|-11.299|0.932
91562428|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|-2.458|STANDARD_ERROR_OF_MEAN|6.3493||0.7|TWO_SIDED|95.0|-15.217|10.302|||ANCOVA|||Dysglycemic||10.302|-15.217|0.700
91562429|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|7.832|STANDARD_ERROR_OF_MEAN|5.0946||0.131|TWO_SIDED|95.0|-2.406|18.07|||ANCOVA|||Dysglycemic||18.070|-2.406|0.131
91562430|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|5.197||0.727|TWO_SIDED|95.0|-8.619|12.269|||ANCOVA|||Dysglycemic||12.269|-8.619|0.727
91562431|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|0.828|STANDARD_ERROR_OF_MEAN|4.5876||0.857|TWO_SIDED|95.0|-8.342|9.999|||ANCOVA|||T2DM||9.999|-8.342|0.857
91562432|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|-0.696|STANDARD_ERROR_OF_MEAN|4.7173||0.883|TWO_SIDED|95.0|-10.126|8.734|||ANCOVA|||T2DM||8.734|-10.126|0.883
91562433|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|-0.975|STANDARD_ERROR_OF_MEAN|4.2883||0.821|TWO_SIDED|95.0|-9.547|7.597|||ANCOVA|||T2DM||7.597|-9.547|0.821
91514038|NCT00996996|182900090|SUPERIORITY_OR_OTHER||Percentage of participants|20.0|||||TWO_SIDED|95.0|11.0|29.0|||||The estimated value represents the percentage of participants with a PR.|||29|11|
91562434|NCT03320941|183013199|OTHER|Dose Finding|Mean Difference (Final Values)|2.488|STANDARD_ERROR_OF_MEAN|4.1111||0.547|TWO_SIDED|95.0|-5.73|10.706|||ANCOVA|||T2DM||10.706|-5.730|0.547
91562435|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|4.954|STANDARD_ERROR_OF_MEAN|3.4006||0.148|TWO_SIDED|95.0|-1.781|11.689|||ANCOVA|||Overall Study||11.689|-1.781|0.148
91562436|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|0.993|STANDARD_ERROR_OF_MEAN|3.4645||0.775|TWO_SIDED|95.0|-5.869|7.855|||ANCOVA|||Overall Study||7.855|-5.869|0.775
91562437|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|-1.799|STANDARD_ERROR_OF_MEAN|3.0432||0.556|TWO_SIDED|95.0|-7.826|4.229|||ANCOVA|||Overall Study||4.229|-7.826|0.556
91562438|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|3.566|STANDARD_ERROR_OF_MEAN|3.0079||0.238|TWO_SIDED|95.0|-2.391|9.524|||ANCOVA|||Overall Study||9.524|-2.391|0.238
91562439|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|3.811|STANDARD_ERROR_OF_MEAN|5.4552||0.488|TWO_SIDED|95.0|-7.152|14.774|||ANCOVA|||Dysglycemic||14.774|-7.152|0.488
91562440|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|4.659|STANDARD_ERROR_OF_MEAN|5.4845||0.4|TWO_SIDED|95.0|-6.363|15.68|||ANCOVA|||Dysglycemic||15.680|-6.363|0.400
91562441|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|4.7651||0.826|TWO_SIDED|95.0|-8.525|10.626|||ANCOVA|||Dysglycemic||10.626|-8.525|0.826
91514039|NCT01227889|182900116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.6||The p value from a stratified log-rank test was adjusted for disease stage at screening.|Log Rank||HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.|||0.60|0.26|<0.0001
91514040|NCT01227889|182900117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||0.61|0.20|
91562442|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|4.182|STANDARD_ERROR_OF_MEAN|4.7627||0.384|TWO_SIDED|95.0|-5.389|13.753|||ANCOVA|||Dysglycemic||13.753|-5.389|0.384
91562443|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|5.563|STANDARD_ERROR_OF_MEAN|4.4636||0.217|TWO_SIDED|95.0|-3.36|14.486|||ANCOVA|||T2DM||14.486|-3.360|0.217
91562444|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|-2.019|STANDARD_ERROR_OF_MEAN|4.5491||0.659|TWO_SIDED|95.0|-11.112|7.074|||ANCOVA|||T2DM||7.074|-11.112|0.659
91562445|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|-4.316|STANDARD_ERROR_OF_MEAN|4.0556||0.291|TWO_SIDED|95.0|-12.423|3.791|||ANCOVA|||T2DM||3.791|-12.423|0.291
91562446|NCT03320941|183013200|OTHER|Dose Finding|Mean Difference (Final Values)|2.913|STANDARD_ERROR_OF_MEAN|4.0035||0.47|TWO_SIDED|95.0|-5.09|10.916|||ANCOVA|||T2DM||10.916|-5.090|0.470
91514041|NCT01227889|182900118|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.57|1.18|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||1.18|0.57|
91562447|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|1.308|STANDARD_ERROR_OF_MEAN|5.2049||0.802|TWO_SIDED|95.0|-9.001|11.617|||ANCOVA|||Overall Study||11.617|-9.001|0.802
91562448|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|-1.812|STANDARD_ERROR_OF_MEAN|5.4301||0.739|TWO_SIDED|95.0|-12.567|8.943|||ANCOVA|||Overall Study||8.943|-12.567|0.739
91562449|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|4.7125||0.901|TWO_SIDED|95.0|-8.745|9.922|||ANCOVA|||Overall Study||9.922|-8.745|0.901
91562450|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|5.278|STANDARD_ERROR_OF_MEAN|4.6095||0.255|TWO_SIDED|95.0|-3.852|14.407|||ANCOVA|||Overall Study||14.407|-3.852|0.255
91562451|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|8.5585||0.914|TWO_SIDED|95.0|-16.271|18.127|||ANCOVA|||Dysglycemic||18.127|-16.271|0.914
91562452|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|9.2308||0.959|TWO_SIDED|95.0|-19.03|18.07|||ANCOVA|||Dysglycemic||18.070|-19.030|0.959
91562453|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|6.572|STANDARD_ERROR_OF_MEAN|7.422||0.38|TWO_SIDED|95.0|-8.343|21.487|||ANCOVA|||Dysglycemic||21.487|-8.343|0.380
91562454|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|6.121|STANDARD_ERROR_OF_MEAN|7.5174||0.419|TWO_SIDED|95.0|-8.986|21.228|||ANCOVA|||Dysglycemic||21.228|-8.986|0.419
91562455|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|6.6209||0.906|TWO_SIDED|95.0|-12.45|14.02|||ANCOVA|||T2DM||14.020|-12.450|0.906
91562456|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|-4.504|STANDARD_ERROR_OF_MEAN|6.8489||0.513|TWO_SIDED|95.0|-18.195|9.187|||ANCOVA|||T2DM||9.187|-18.195|0.513
91562457|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|-4.237|STANDARD_ERROR_OF_MEAN|6.23||0.499|TWO_SIDED|95.0|-16.691|8.216|||ANCOVA|||T2DM||8.216|-16.691|0.499
91562458|NCT03320941|183013201|OTHER|Dose Finding|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|5.9073||0.516|TWO_SIDED|95.0|-7.948|15.669|||ANCOVA|||T2DM||15.669|-7.948|0.516
91769190|NCT02365649|183425733|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||22.1|-3.0|0.488
91769191|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|20.0||||0.295|TWO_SIDED|95.0|2.5|37.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||37.5|2.5|0.295
91769192|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|13.8||||0.355|TWO_SIDED|95.0|-7.4|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||34.9|-7.4|0.355
91769193|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||15.1|-55.1|0.384
91514042|NCT02203019|182900128|EQUIVALENCE|Outcome comparison used the Mann Whitney U test||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
91514043|NCT02203019|182900129|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
91514044|NCT02203019|182900130|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
91514045|NCT02203019|182900131|EQUIVALENCE|Outcomes were compared using a Chi square test.||||||0.739|||||||Chi-squared|||||||0.739
91514046|NCT01148810|182900132|SUPERIORITY_OR_OTHER||Bayesian analysis|0.96|||||||||||||||Probability that the difference (BAF312-Placebo) is greater than the threshold|||
91514047|NCT02165722|182900143|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
91514048|NCT02165722|182900143|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
91514049|NCT02165722|182900143|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.||||<0.001
91514050|NCT02165722|182900143|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||<0.001
91514051|NCT02165722|182900144|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001
91514052|NCT02165722|182900144|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
91514053|NCT02165722|182900144|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
91514054|NCT02165722|182900144|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
91514055|NCT02731131|182900156|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
91514056|NCT02731131|182900158|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
91514057|NCT02731131|182900159|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
91514058|NCT02731131|182900160|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
91514059|NCT02731131|182900161|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
91514060|NCT02509624|182900178|OTHER||%Geometric least-square mean(GLSM) ratio|105.08|||||TWO_SIDED|90.0|77.08|143.23||||||AUCinf of selonsertib||143.23|77.08|
91514061|NCT02509624|182900178|OTHER||% GLSM ratio|142.65|||||TWO_SIDED|90.0|120.52|168.84||||||AUCinf of selonsertib||168.84|120.52|
91514062|NCT02509624|182900178|OTHER||% GLSM ratio|110.55|||||TWO_SIDED|90.0|86.99|140.49||||||AUCinf of selonsertib||140.49|86.99|
91514063|NCT02509624|182900178|OTHER||% GLSM ratio|62.05|||||TWO_SIDED|90.0|43.84|87.81||||||AUCinf of GS-607509||87.81|43.84|
91514064|NCT02509624|182900178|OTHER||% GLSM ratio|66.44|||||TWO_SIDED|90.0|36.72|120.21||||||AUCinf of GS-607509||120.21|36.72|
91514065|NCT02509624|182900178|OTHER||% GLSM ratio|103.46|||||TWO_SIDED|90.0|51.75|206.83||||||AUCinf of GS-607509||206.83|51.75|
91514066|NCT02509624|182900179|OTHER||% GLSM ratio|99.87|||||TWO_SIDED|90.0|73.38|135.92||||||AUClast of selonsertib||135.92|73.38|
91514067|NCT02509624|182900179|OTHER||% GLSM ratio|141.75|||||TWO_SIDED|90.0|118.5|169.55||||||AUClast of selonsertib||169.55|118.50|
91514068|NCT02509624|182900179|OTHER||% GLSM ratio|112.24|||||TWO_SIDED|90.0|87.69|143.65||||||AUClast of selonsertib||143.65|87.69|
91514069|NCT02509624|182900179|OTHER||% GLSM ratio|61.2|||||TWO_SIDED|90.0|43.06|86.98||||||AUClast of GS-607509||86.98|43.06|
91514070|NCT02509624|182900179|OTHER||% GLSM ratio|61.07|||||TWO_SIDED|90.0|33.62|110.91||||||AUClast of GS-607509||110.91|33.62|
91514071|NCT02509624|182900179|OTHER||% GLSM ratio|96.13|||||TWO_SIDED|90.0|48.47|190.67||||||AUClast of GS-607509||190.67|48.47|
91514072|NCT02509624|182900180|OTHER||% GLSM ratio|88.68|||||TWO_SIDED|90.0|74.83|105.1||||||Cmax of selonsertib||105.10|74.83|
91514073|NCT02509624|182900180|OTHER||% GLSM ratio|91.16|||||TWO_SIDED|90.0|78.76|105.52||||||Cmax of selonsertib||105.52|78.76|
91514074|NCT02509624|182900180|OTHER||% GLSM ratio|100.19|||||TWO_SIDED|90.0|83.73|119.88||||||Cmax of selonsertib||119.88|83.73|
91514075|NCT02509624|182900180|OTHER||% GLSM ratio|71.44|||||TWO_SIDED|90.0|54.58|93.5||||||Cmax of GS-607509||93.50|54.58|
91514076|NCT02509624|182900180|OTHER||% GLSM ratio|46.92|||||TWO_SIDED|90.0|32.59|67.54||||||Cmax of GS-607509||67.54|32.59|
91514077|NCT02509624|182900180|OTHER||% GLSM ratio|93.93|||||TWO_SIDED|90.0|67.6|130.5||||||Cmax of GS-607509||130.50|67.60|
91514078|NCT01055639|182900211|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
91514079|NCT01055639|182900212|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
91514080|NCT01055639|182900213|SUPERIORITY_OR_OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
91514081|NCT01055639|182900214|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
91514082|NCT01055639|182900215|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||||||0.87
91514083|NCT01055639|182900216|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
91514084|NCT01055639|182900217|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||||||0.19
91514085|NCT01055639|182900218|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
91514086|NCT01055639|182900219|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
91514087|NCT02334800|182900281|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|73.6|||||TWO_SIDED|90.0|57.81|93.71||||||||93.71|57.81|
91514088|NCT02334800|182900281|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.3|||||TWO_SIDED|90.0|90.57|146.79||||||||146.79|90.57|
91514089|NCT02334800|182900281|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|133.68|||||TWO_SIDED|90.0|105.0|170.19||||||||170.19|105.00|
91514090|NCT02334800|182900282|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|94.99|||||TWO_SIDED|90.0|69.93|129.03||||||||129.03|69.93|
91514091|NCT02334800|182900282|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|117.75|||||TWO_SIDED|90.0|86.69|159.95||||||||159.95|86.69|
91514092|NCT02334800|182900282|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|129.89|||||TWO_SIDED|90.0|95.63|176.43||||||||176.43|95.63|
91514093|NCT02334800|182900283|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|83.01|||||TWO_SIDED|90.0|65.37|105.43||||||||105.43|65.37|
91514094|NCT02334800|182900283|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.28|||||TWO_SIDED|90.0|105.73|170.53||||||||170.53|105.73|
91514095|NCT02334800|182900283|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|176.88|||||TWO_SIDED|90.0|139.28|224.63||||||||224.63|139.28|
91514096|NCT02334800|182900284|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|72.81|||||TWO_SIDED|90.0|56.43|93.93||||||||93.93|56.43|
91514097|NCT02334800|182900284|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.57|||||TWO_SIDED|90.0|89.58|149.11||||||||149.11|89.58|
91514098|NCT02334800|182900284|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.66|||||TWO_SIDED|90.0|104.38|173.73||||||||173.73|104.38|
91514099|NCT02334800|182900285|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|82.14|||||TWO_SIDED|90.0|63.83|105.71||||||||105.71|63.83|
91514100|NCT02334800|182900285|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.9|||||TWO_SIDED|90.0|104.82|173.6||||||||173.60|104.82|
91514101|NCT02334800|182900285|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|178.39|||||TWO_SIDED|90.0|138.62|229.57||||||||229.57|138.62|
91514102|NCT02334800|182900288|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|107.37|||||TWO_SIDED|90.0|78.06|147.68||||||||147.68|78.06|
91514103|NCT02334800|182900288|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|137.5|||||TWO_SIDED|90.0|99.96|189.12||||||||189.12|99.96|
91514104|NCT02334800|182900288|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|172.27|||||TWO_SIDED|90.0|125.25|236.96||||||||236.96|125.25|
91514105|NCT00575588|182900304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
91514106|NCT00575588|182900305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-28.5||Between group comparison significant after controlling overall alpha of the study|Fisher Exact|||||-28.5|-38.1|<0.0001
91514107|NCT00575588|182900306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001||95.0|-2.7|-1.7||Between group comparison significant after controlling overall alpha of the study|ANCOVA|||||-1.7|-2.7|<0.0001
91514108|NCT00575588|182900307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.04|TWO_SIDED|95.0|-0.0046|-0.0001||Between group comparison significant after controlling overall alpha of the study|Mixed Models Analysis|||||-0.0001|-0.0046|0.040
91514109|NCT00575588|182900308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.06|||Repeated Measures|||||0.06|-0.17|
91514110|NCT00575588|182900309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.9|||||TWO_SIDED|95.0|-39.8|-30.0||||||||-30.0|-39.8|
91514111|NCT00575588|182900310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|95.0|-3.32|-2.2|||Repeated Measures|||||-2.20|-3.32|
91514112|NCT00575588|182900311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0007|||TWO_SIDED|95.0|-0.0048|-0.0022|||Mixed Models Analysis|||||-0.0022|-0.0048|
91514113|NCT02265705|182900312|SUPERIORITY||Odds Ratio (OR)|4.1||||0.001|TWO_SIDED|95.0|2.5|6.9|||Regression, Logistic|||||6.9|2.5|0.001
91514114|NCT02265705|182900313|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.056||0.001|TWO_SIDED|95.0|-0.31|-0.09|||ANCOVA|||||-0.09|-0.31|0.001
91562459|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|44.82||||0.625|TWO_SIDED|95.0|-136.644|226.284|||ANCOVA|||Overall Study||226.284|-136.644|0.625
91562460|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|162.273||||0.079|TWO_SIDED|95.0|-19.326|343.871|||ANCOVA|||Overall Study||343.871|-19.326|0.079
91562461|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|69.062||||0.384|TWO_SIDED|95.0|-87.493|225.617|||ANCOVA|||Overall Study||225.617|-87.493|0.384
91562462|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|37.733||||0.627|TWO_SIDED|95.0|-115.58|191.045|||ANCOVA|||Overall Study||191.045|-115.580|0.627
91562463|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|22.879||||0.797|TWO_SIDED|95.0|-155.244|201.003|||ANCOVA|||Dysglycemic||201.003|-155.244|0.797
91562464|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|12.891||||0.882|TWO_SIDED|95.0|-160.215|185.996|||ANCOVA|||Dysglycemic||185.996|-160.215|0.882
91769194|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-22.5||||0.311|TWO_SIDED|95.0|-59.5|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||14.5|-59.5|0.311
91562465|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|-30.447||||0.675|TWO_SIDED|95.0|-175.796|114.902|||ANCOVA|||Dysglycemic||114.902|-175.796|0.675
91562466|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|-37.264||||0.607|TWO_SIDED|95.0|-182.099|107.571|||ANCOVA|||Dysglycemic||107.571|-182.099|0.607
91769195|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-16.3||||0.422|TWO_SIDED|95.0|-43.8|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||11.3|-43.8|0.422
91769196|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||9.2|-59.2|0.181
91769197|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||44.0|6.0|0.281
91514115|NCT02265705|182900314|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.116||0.001|TWO_SIDED|95.0|-1.25|-0.79|||ANCOVA|||||-0.79|-1.25|0.001
91514116|NCT02265705|182900315|SUPERIORITY||Difference in response rate|1.4|||||TWO_SIDED|95.0|-0.5|3.3||||||||3.3|-0.5|
91514117|NCT02265705|182900316|SUPERIORITY||Median Difference (Final Values)|-12.9||||0.004|TWO_SIDED|95.0|-28.0|-2.9|||Wilcoxon (Mann-Whitney)|||||-2.9|-28.0|0.004
91562467|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|84.822||||0.591|TWO_SIDED|95.0|-229.131|398.775|||ANCOVA|||T2DM||398.775|-229.131|0.591
91562468|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|287.328||||0.066|TWO_SIDED|95.0|-19.533|594.19|||ANCOVA|||T2DM||594.190|-19.533|0.066
91562469|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|156.017||||0.252|TWO_SIDED|95.0|-113.963|425.997|||ANCOVA|||T2DM||425.997|-113.963|0.252
91562470|NCT03320941|183013202|OTHER|Dose Finding|Mean Difference (Final Values)|103.135||||0.431|TWO_SIDED|95.0|-157.287|363.556|||ANCOVA|||T2DM||363.556|-157.287|0.431
91562471|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-65.1|STANDARD_ERROR_OF_MEAN|13.03|<|0.001|TWO_SIDED|95.0|-90.864|-39.251|||ANCOVA|||Overall Study||-39.251|-90.864|<0.001
91562472|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-67.7|STANDARD_ERROR_OF_MEAN|13.21|<|0.001|TWO_SIDED|95.0|-93.848|-41.542|||ANCOVA|||Overall Study||-41.542|-93.848|<0.001
91562473|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-70.8|STANDARD_ERROR_OF_MEAN|11.67|<|0.001|TWO_SIDED|95.0|-93.942|-47.735|||ANCOVA|||Overall Study||-47.735|-93.942|<0.001
91562474|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-74.4|STANDARD_ERROR_OF_MEAN|11.47|<|0.001|TWO_SIDED|95.0|-97.117|-51.704|||ANCOVA|||Overall Study||-51.704|-97.117|<0.001
91562475|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-86.9|STANDARD_ERROR_OF_MEAN|24.35|<|0.001|TWO_SIDED|95.0|-135.78|-38.013|||ANCOVA|||Dysglycemic||-38.013|-135.780|<0.001
91562476|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-86.1|STANDARD_ERROR_OF_MEAN|24.01|<|0.001|TWO_SIDED|95.0|-134.266|-37.874|||ANCOVA|||Dysglycemic||-37.874|-134.266|<0.001
91562477|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-81.1|STANDARD_ERROR_OF_MEAN|21.04|<|0.001|TWO_SIDED|95.0|-123.369|-38.883|||ANCOVA|||Dysglycemic||-38.883|-123.369|<0.001
91562478|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-84.9|STANDARD_ERROR_OF_MEAN|21.03|<|0.001|TWO_SIDED|95.0|-127.104|-42.669|||ANCOVA|||Dysglycemic||-42.669|-127.104|<0.001
91769198|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||28.5|-28.5|1.000
91514118|NCT02265705|182900317|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.002
91514119|NCT02265705|182900318|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|0.001
91562479|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-47.5|STANDARD_ERROR_OF_MEAN|13.52|<|0.001|TWO_SIDED|95.0|-74.493|-20.461|||ANCOVA|||T2DM||-20.461|-74.493|<0.001
91562480|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|13.93|<|0.001|TWO_SIDED|95.0|-80.914|-25.251|||ANCOVA|||T2DM||-25.251|-80.914|<0.001
91562481|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-61.8|STANDARD_ERROR_OF_MEAN|12.43|<|0.001|TWO_SIDED|95.0|-86.627|-36.937|||ANCOVA|||T2DM||-36.937|-86.627|<0.001
91562482|NCT03320941|183013203|OTHER|Dose Finding|Mean Difference (Final Values)|-65.0|STANDARD_ERROR_OF_MEAN|12.15|<|0.001|TWO_SIDED|95.0|-89.291|-40.713|||ANCOVA|||T2DM||-40.713|-89.291|<0.001
91562483|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-0.556|STANDARD_ERROR_OF_MEAN|1.845||0.764|TWO_SIDED|95.0|-4.21|3.098|||ANCOVA|||Overall Study||3.098|-4.210|0.764
91562484|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|1.289|STANDARD_ERROR_OF_MEAN|1.8741||0.493|TWO_SIDED|95.0|-2.423|5.001|||ANCOVA|||Overall Study||5.001|-2.423|0.493
91562485|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-2.621|STANDARD_ERROR_OF_MEAN|1.6596||0.117|TWO_SIDED|95.0|-5.908|0.666|||ANCOVA|||Overall Study||0.666|-5.908|0.117
91562486|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-1.818|STANDARD_ERROR_OF_MEAN|1.6349||0.269|TWO_SIDED|95.0|-5.056|1.421|||ANCOVA|||Overall Study||1.421|-5.056|0.269
91562487|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|1.671|STANDARD_ERROR_OF_MEAN|1.1677||0.159|TWO_SIDED|95.0|-0.676|4.017|||ANCOVA|||Dysglycemic||4.017|-0.676|0.159
91562488|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|5.641|STANDARD_ERROR_OF_MEAN|1.1678|<|0.001|TWO_SIDED|95.0|3.294|7.988|||ANCOVA|||Dysglycemic||7.988|3.294|<0.001
91562489|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|1.155|STANDARD_ERROR_OF_MEAN|1.0371||0.271|TWO_SIDED|95.0|-0.929|3.239|||ANCOVA|||Dysglycemic||3.239|-0.929|0.271
91562490|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|1.019||0.841|TWO_SIDED|95.0|-1.842|2.253|||ANCOVA|||Dysglycemic||2.253|-1.842|0.841
91562491|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-3.725|STANDARD_ERROR_OF_MEAN|2.518||0.144|TWO_SIDED|95.0|-8.758|1.309|||ANCOVA|||T2DM||1.309|-8.758|0.144
91514120|NCT02265705|182900319|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|||||-0.5|-1.3|0.001
91514121|NCT02703844|182900320|SUPERIORITY|||||||0.0089|||||||ANCOVA|||||||0.0089
91514122|NCT00801684|182900338|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The difference between the active treatment was compared to placebo. For a null hypothesis, the difference would equal 0 (zero).||||<0.0001
91562492|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-0.877|STANDARD_ERROR_OF_MEAN|2.5906||0.736|TWO_SIDED|95.0|-6.055|4.302|||ANCOVA|||T2DM||4.302|-6.055|0.736
91562493|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-3.431|STANDARD_ERROR_OF_MEAN|2.3113||0.143|TWO_SIDED|95.0|-8.051|1.19|||ANCOVA|||T2DM||1.190|-8.051|0.143
91562494|NCT03320941|183013204|OTHER|Dose Finding|Mean Difference (Final Values)|-1.991|STANDARD_ERROR_OF_MEAN|2.2659||0.383|TWO_SIDED|95.0|-6.521|2.538|||ANCOVA|||T2DM||2.538|-6.521|0.383
91562495|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|0.654|STANDARD_ERROR_OF_MEAN|1.1543||0.572|TWO_SIDED|95.0|-1.632|2.941|||ANCOVA|||Overall Study||2.941|-1.632|0.572
91562496|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|0.655|STANDARD_ERROR_OF_MEAN|1.1738||0.578|TWO_SIDED|95.0|-1.67|2.98|||ANCOVA|||Overall Study||2.980|-1.670|0.578
91562497|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|-1.048|STANDARD_ERROR_OF_MEAN|1.0479||0.319|TWO_SIDED|95.0|-3.124|1.028|||ANCOVA|||Overall Study||1.028|-3.124|0.319
91562498|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|-0.374|STANDARD_ERROR_OF_MEAN|1.0303||0.717|TWO_SIDED|95.0|-2.416|1.667|||ANCOVA|||Overall Study||1.667|-2.416|0.717
91562499|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.563||0.317|TWO_SIDED|95.0|-0.562|1.701|||ANCOVA|||Dysglycemic||1.701|-0.562|0.317
91562500|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|1.609|STANDARD_ERROR_OF_MEAN|0.5716||0.007|TWO_SIDED|95.0|0.46|2.758|||ANCOVA|||Dysglycemic||2.758|0.460|0.007
91562501|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.5029||0.487|TWO_SIDED|95.0|-0.659|1.362|||ANCOVA|||Dysglycemic||1.362|-0.659|0.487
91562502|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.4917||0.833|TWO_SIDED|95.0|-0.884|1.092|||ANCOVA|||Dysglycemic||1.092|-0.884|0.833
91562503|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|2.073||0.771|TWO_SIDED|95.0|-3.541|4.752|||ANCOVA|||T2DM||4.752|-3.541|0.771
91562504|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|2.1453||0.991|TWO_SIDED|95.0|-4.315|4.267|||ANCOVA|||T2DM||4.267|-4.315|0.991
91562505|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|-2.166|STANDARD_ERROR_OF_MEAN|1.9486||0.271|TWO_SIDED|95.0|-6.064|1.732|||ANCOVA|||T2DM||1.732|-6.064|0.271
91562506|NCT03320941|183013205|OTHER|Dose Finding|Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|1.8889||0.676|TWO_SIDED|95.0|-4.57|2.986|||ANCOVA|||T2DM||2.986|-4.570|0.676
91562507|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.7535||0.968|TWO_SIDED|95.0|-9.603|9.222|||ANCOVA|||Overall Study||9.222|-9.603|0.968
91562508|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-1.883|STANDARD_ERROR_OF_MEAN|4.7545||0.693|TWO_SIDED|95.0|-11.297|7.531|||ANCOVA|||Overall Study||7.531|-11.297|0.693
91562509|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-5.236|STANDARD_ERROR_OF_MEAN|4.2623||0.222|TWO_SIDED|95.0|-13.676|3.203|||ANCOVA|||Overall Study||3.203|-13.676|0.222
91562510|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-7.403|STANDARD_ERROR_OF_MEAN|4.1637||0.078|TWO_SIDED|95.0|-15.648|0.841|||ANCOVA|||Overall Study||0.841|-15.648|0.078
91514123|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.132|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.132
91562511|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-1.142|STANDARD_ERROR_OF_MEAN|6.0033||0.85|TWO_SIDED|95.0|-13.194|10.91|||ANCOVA|||Dysglycemic||10.910|-13.194|0.850
91562512|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-6.048|STANDARD_ERROR_OF_MEAN|5.7919||0.301|TWO_SIDED|95.0|-17.676|5.58|||ANCOVA|||Dysglycemic||5.580|-17.676|0.301
91562513|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-5.587|STANDARD_ERROR_OF_MEAN|5.2598||0.293|TWO_SIDED|95.0|-16.147|4.972|||ANCOVA|||Dysglycemic||4.972|-16.147|0.293
91514124|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.658|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.658
91514125|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.142|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.142
91514126|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.207|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.207
91514127|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.077|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.077
91514128|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.331|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||0.331
91514129|NCT02828111|182900342|OTHER|Pairwise comparison||||||0.117|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of all four patidegib gel treatment groups combined compared with vehicle gel at Week 12.||||0.117
91514130|NCT02828111|182900346|OTHER|Pairwise comparison||||||0.038|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.038
91514131|NCT02828111|182900346|OTHER|Pairwise comparison||||||0.099|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.099
91514132|NCT02828111|182900346|OTHER|Pairwise comparison||||||0.198|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.198
91514133|NCT02828111|182900346|OTHER|Pairwise comparison||||||0.757|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.757
91514134|NCT02828111|182900347|OTHER|Pairwise comparison||||||0.043|||||||Fisher Exact|||at Week 12||||0.043
91514135|NCT02828111|182900347|OTHER|Pairwise comparison||||||0.312|||||||Fisher Exact|||at Week 12||||0.312
91514136|NCT02828111|182900347|OTHER|Pairwise comparison||||||0.353|||||||Fisher Exact|||at Week 12||||0.353
91514137|NCT02828111|182900347|OTHER|Pairwise comparison||||||0.093|||||||Fisher Exact|||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.093
91514138|NCT02828111|182900347|OTHER|Pairwise comparison||||||1|||||||Fisher Exact|||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||1.000
91514139|NCT02828111|182900347|OTHER|Pairwise comparison||||||0.157|||||||Fisher Exact|||This is the analysis of all four patidegib gel treatment groups combined compared with combined vehicle gel at Week 12.||||0.157
91514140|NCT00614939|182900348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.151||0.007|TWO_SIDED|95.0|-0.71|-0.12|||ANCOVA|\*Adjusted for baseline HbA1c||||-0.12|-0.71|0.007
91514141|NCT00614939|182900349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.34|STANDARD_ERROR_OF_MEAN|12.847||0.339||95.0|-37.91|13.22|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||13.22|-37.91|0.339
91514142|NCT00614939|182900350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|16.938||0.798|TWO_SIDED|95.0|-38.65|29.93|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||29.93|-38.65|0.798
91514143|NCT00614939|182900351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.01|STANDARD_ERROR_OF_MEAN|30.815||0.164|TWO_SIDED|95.0|-18.93|106.94|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||106.94|-18.93|0.164
91514144|NCT00614939|182900352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.713|||TWO_SIDED|95.0|-2.1|0.74|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||0.74|-2.10|
91514145|NCT00614939|182900353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.941|||TWO_SIDED|95.0|-2.14|1.67|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.67|-2.14|
91514146|NCT00614939|182900354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-1.05|5.93|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||5.93|-1.05|
91514147|NCT00614939|182900355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|-1.27|-0.37|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=26 for saxagliptin and n=34 for placebo~\*Adjusted for baseline HbA1c"||||-0.37|-1.27|
91514148|NCT00614939|182900356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.98|STANDARD_ERROR_OF_MEAN|18.475|||TWO_SIDED|95.0|-54.28|18.33|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||18.33|-54.28|
91769199|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||11.3|-61.3|0.231
91562514|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-6.943|STANDARD_ERROR_OF_MEAN|5.2191||0.189|TWO_SIDED|95.0|-17.421|3.535|||ANCOVA|||Dysglycemic||3.535|-17.421|0.189
91562515|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|0.676|STANDARD_ERROR_OF_MEAN|7.2441||0.926|TWO_SIDED|95.0|-13.8|15.152|||ANCOVA|||T2DM||15.152|-13.800|0.926
91769200|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|27.5||||0.214|TWO_SIDED|95.0|-3.9|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||58.9|-3.9|0.214
91769201|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|21.3||||0.277|TWO_SIDED|95.0|-7.5|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||50.0|-7.5|0.277
91769202|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||17.2|-57.2|0.442
91769203|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|20.0||||0.419|TWO_SIDED|95.0|-17.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||57.1|-17.1|0.419
91769204|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|20.0||||0.214|TWO_SIDED|95.0|-10.4|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||50.4|-10.4|0.214
91769205|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
91769206|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|23.1||||0.284|TWO_SIDED|95.0|-10.1|56.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.4|-10.1|0.284
91769207|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|0.2||||0.988|TWO_SIDED|95.0|-23.9|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||24.3|-23.9|0.988
91769208|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-12.1||||0.37|TWO_SIDED|95.0|-38.1|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||13.9|-38.1|0.370
91562516|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|1.202|STANDARD_ERROR_OF_MEAN|7.5086||0.873|TWO_SIDED|95.0|-13.802|16.207|||ANCOVA|||T2DM||16.207|-13.802|0.873
91562517|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-5.779|STANDARD_ERROR_OF_MEAN|6.6977||0.391|TWO_SIDED|95.0|-19.164|7.605|||ANCOVA|||T2DM||7.605|-19.164|0.391
91769209|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|25.6||||0.268|TWO_SIDED|95.0|-8.9|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||60.2|-8.9|0.268
91769210|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-5.0||||0.665|TWO_SIDED|95.0|-27.4|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||17.5|-27.4|0.665
91769211|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-3.9||||0.759|TWO_SIDED|95.0|-28.9|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||21.0|-28.9|0.759
91562518|NCT03320941|183013206|OTHER|Dose Finding|Mean Difference (Final Values)|-7.591|STANDARD_ERROR_OF_MEAN|6.3822||0.239|TWO_SIDED|95.0|-20.345|5.163|||ANCOVA|||T2DM||5.163|-20.345|0.239
91562519|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-3.086|STANDARD_ERROR_OF_MEAN|2.8326||0.278|TWO_SIDED|95.0|-8.696|2.525|||ANCOVA|||Overall Study||2.525|-8.696|0.278
91562520|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-0.977|STANDARD_ERROR_OF_MEAN|2.859||0.733|TWO_SIDED|95.0|-6.639|4.686|||ANCOVA|||Overall Study||4.686|-6.639|0.733
91562521|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-4.507|STANDARD_ERROR_OF_MEAN|2.5118||0.075|TWO_SIDED|95.0|-9.482|0.468|||ANCOVA|||Overall Study||0.468|-9.482|0.075
91562522|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-2.268|STANDARD_ERROR_OF_MEAN|2.4659||0.36|TWO_SIDED|95.0|-7.152|2.616|||ANCOVA|||Overall Study||2.616|-7.152|0.360
91562523|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-3.147|STANDARD_ERROR_OF_MEAN|4.1699||0.416|TWO_SIDED|95.0|-11.792|4.959|||ANCOVA|||Dysglycemic||4.959|-11.792|0.416
91562524|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-1.634|STANDARD_ERROR_OF_MEAN|4.1121||0.693|TWO_SIDED|95.0|-9.893|6.625|||ANCOVA|||Dysglycemic||6.625|-9.893|0.693
91562525|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-2.906|STANDARD_ERROR_OF_MEAN|3.6351||0.428|TWO_SIDED|95.0|-10.207|4.396|||ANCOVA|||Dysglycemic||4.396|-10.207|0.428
91562526|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|2.201|STANDARD_ERROR_OF_MEAN|3.6414||0.548|TWO_SIDED|95.0|-5.113|9.515|||ANCOVA|||Dysglycemic||9.515|-5.113|0.548
91562527|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-2.636|STANDARD_ERROR_OF_MEAN|3.8828||0.5|TWO_SIDED|95.0|-10.4|5.128|||ANCOVA|||T2DM||5.128|-10.400|0.500
91562528|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|3.9906||0.837|TWO_SIDED|95.0|-8.805|7.154|||ANCOVA|||T2DM||7.154|-8.805|0.837
91562529|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-5.594|STANDARD_ERROR_OF_MEAN|3.4818||0.113|TWO_SIDED|95.0|-12.556|1.368|||ANCOVA|||T2DM||1.368|-12.556|0.113
91562530|NCT03320941|183013207|OTHER|Dose Finding|Mean Difference (Final Values)|-5.66|STANDARD_ERROR_OF_MEAN|3.3512||0.096|TWO_SIDED|95.0|-12.361|1.041|||ANCOVA|||T2DM||1.041|-12.361|0.096
91769212|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||56.6|-12.8|0.259
91769213|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||19.9|-23.2|0.880
91562531|NCT01114217|183013246|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91562532|NCT01837719|183013253|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (fixed-dose combination \[FDC\] tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC\[0-T\]) and AUC from time 0 to infinity. (AUC\[0-T\])|Geometric mean ratio|1.073|||||TWO_SIDED|90.0|1.012|1.137|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax, with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.137|1.012|
91562533|NCT01837719|183013253|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.423|||||TWO_SIDED|90.0|1.273|1.59|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.590|1.273|
91562534|NCT01837719|183013253|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.137|||||TWO_SIDED|90.0|1.0|1.292|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.292|1.000|
91562535|NCT01837719|183013253|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.862|||||TWO_SIDED|90.0|0.701|1.059|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.059|0.701|
91562536|NCT01837719|183013253|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.643|||||TWO_SIDED|90.0|0.545|0.759|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.759|0.545|
91562537|NCT01837719|183013254|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|Geometric mean ratio|1.065|||||TWO_SIDED|90.0|1.012|1.12|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment B/Treatment A|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).||1.120|1.012|
91562538|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.275|||||TWO_SIDED|90.0|1.166|1.393|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as a random effect was used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.393|1.166|
91562539|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.113|||||TWO_SIDED|90.0|0.993|1.248|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.248|0.993|
91562540|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.804|1.122|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC.||1.122|0.804|
91562541|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.746|||||TWO_SIDED|90.0|0.655|0.849|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.849|0.655|
91562542|NCT01837719|183013254|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|Geometric mean ratio|1.064||||||90.0|1.011|1.12|||Mixed Models Analysis||Geometric mean ration for AUC(INF) is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment period and sequence as fixed effects, and patient (sequence) as a random effect.||1.120|1.011|
91562543|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.28|||||TWO_SIDED|90.0|1.171|1.398|||Mixed Models Analysis||Geometric mean ratio for AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of a light meal and fthe fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.398|1.171|
91562544|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|0.991|1.244|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.244|0.991|
91514149|NCT00614939|182900357|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.73|STANDARD_ERROR_OF_MEAN|25.326|||TWO_SIDED|95.0|-65.77|34.3|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||34.30|-65.77|
91562545|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.956|||||TWO_SIDED|90.0|0.81|1.128|||Mixed Models Analysis||Geometric mean of AUC(INF) was calculated as Treatment E/Treatment D|||1.128|0.810|
91562546|NCT01837719|183013254|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.749|||||TWO_SIDED|90.0|0.658|0.852|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when administered as an FDC.||0.852|0.658|
91562547|NCT01837719|183013259|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.084|||||TWO_SIDED|90.0|1.014|1.158|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.158|1.014|
91562548|NCT01837719|183013259|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.349|||||TWO_SIDED|90.0|1.215|1.498|||Mixed Models Analysis||Geometric mean ratio of C24 was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.498|1.215|
91562549|NCT01837719|183013259|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.144||||||90.0|1.006|1.3|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.300|1.006|
91562550|NCT01837719|183013259|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.231|||||TWO_SIDED|90.0|1.023|1.483|||||Geometric mean ratio was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.483|1.023|
91562551|NCT01837719|183013259|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.912||||||90.0|0.789|1.054|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.054|0.789|
91769214|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||11.2|-32.7|0.355
91769215|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||37.1|-27.1|1.000
91769216|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|4.4||||0.688|TWO_SIDED|95.0|-17.0|25.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||25.9|-17.0|0.688
91769217|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|1.1||||0.927|TWO_SIDED|95.0|-22.3|24.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||24.5|-22.3|0.927
91769218|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||60.0|-5.0|0.075
91769219|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|14.0||||0.154|TWO_SIDED|95.0|-4.8|32.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||32.7|-4.8|0.154
91769220|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||24.2|-14.4|0.707
91514150|NCT00614939|182900358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-38.09|STANDARD_ERROR_OF_MEAN|53.822|||TWO_SIDED|95.0|-144.44|68.26|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||68.26|-144.44|
91514151|NCT00614939|182900359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|95.0|-2.99|1.04|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.04|-2.99|
91514152|NCT00614939|182900360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.405|||TWO_SIDED|95.0|-3.66|1.89|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.89|-3.66|
91514153|NCT00614939|182900361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14|STANDARD_ERROR_OF_MEAN|2.985|||TWO_SIDED|95.0|-8.04|3.76|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||3.76|-8.04|
91514154|NCT02079805|182900376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-0.89|1.78||||||Telmisartan 40 mg, Azilsartan 20 mg||1.78|-0.89|
91514155|NCT00383435|182900392|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91514156|NCT00383435|182900392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||ANCOVA|||||||0.007
91514157|NCT00383435|182900393|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
91514158|NCT00383435|182900393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029|||||||ANCOVA|||||||0.029
91514159|NCT00383435|182900394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||||||0.002
91514160|NCT00383435|182900394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059|||||||ANCOVA|||||||0.059
91518067|NCT02273141|182910399|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|4.43||||0.064|TWO_SIDED|95.0|-4.36|13.1||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||13.10|-4.36|0.064
91769221|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|25.0||||0.085|TWO_SIDED|95.0|10.0|40.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||40.0|10.0|0.085
91769222|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|14.7||||0.137|TWO_SIDED|95.0|-4.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||33.3|-4.0|0.137
91769223|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-11.8||||0.37|TWO_SIDED|95.0|-38.2|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||14.5|-38.2|0.370
91769224|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-3.6||||1|TWO_SIDED|95.0|-31.6|24.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||24.4|-31.6|1.000
91769225|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-16.4||||0.174|TWO_SIDED|95.0|-39.8|7.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||7.0|-39.8|0.174
91769226|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-17.1||||0.203|TWO_SIDED|95.0|-43.9|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||9.7|-43.9|0.203
91769227|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|20.1||||0.286|TWO_SIDED|95.0|-4.5|44.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||44.7|-4.5|0.286
91769228|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-3.6||||0.773|TWO_SIDED|95.0|-27.7|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||20.6|-27.7|0.773
91769229|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||4.1|-51.2|0.101
91769230|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|15.2||||0.332|TWO_SIDED|95.0|-14.1|44.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||44.4|-14.1|0.332
91769231|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|16.2||||0.189|TWO_SIDED|95.0|-7.5|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.8|-7.5|0.189
91518085|NCT06242444|182910452|SUPERIORITY||Geometric Mean Ratio|1.59|||<|0.0001|TWO_SIDED|95.0|1.42|1.78|||Mixed Models Analysis|||At 12 hours of intra-oral exposure||1.78|1.42|<.0001
91769232|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-14.1||||0.329|TWO_SIDED|95.0|-42.2|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||13.9|-42.2|0.329
91518086|NCT06242444|182910453|SUPERIORITY||Adjusted Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.0277|<|0.0001|TWO_SIDED|95.0|0.252|0.362|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||0.362|0.252|<.0001
91518087|NCT06242444|182910453|SUPERIORITY||Adjusted Mean Difference|0.242|STANDARD_ERROR_OF_MEAN|0.0257|<|0.0001|TWO_SIDED|95.0|0.19|0.293|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||0.293|0.190|<.0001
91769233|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||53.9|-4.8|0.124
91769234|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||39.9|-9.5|0.234
91562552|NCT01837719|183013261|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.023|||||TWO_SIDED|90.0|0.991|1.057|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.057|0.991|
91562553|NCT01837719|183013261|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.305|||||TWO_SIDED|90.0|1.215|1.402|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.402|1.215|
91518088|NCT02046980|182910458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.02839|TWO_SIDED|95.0|1.58|7.31|||Regression, Logistic|||||7.31|1.58|0.02839
91518089|NCT02046980|182910458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||0.0366|TWO_SIDED|95.0|1.25|5.67|||Regression, Logistic|||||5.67|1.25|0.0366
91518090|NCT04575467|182910465|SUPERIORITY||Mean absolute fat thickness difference|-4.77|STANDARD_DEVIATION|2.29|<|0.01|TWO_SIDED|95.0|-7.17|-2.37|||Paired t-test|||||-2.37|-7.17|<0.01
91518091|NCT04575467|182910465|SUPERIORITY||Mean absolute fat thickness difference|-4.85|STANDARD_DEVIATION|2.02|<|0.01|TWO_SIDED|95.0|-6.97|-2.73|||Paired t-test|||||-2.73|-6.97|<0.01
91518092|NCT04575467|182910465|SUPERIORITY||Mean absolute fat thickness difference|-2.98|STANDARD_DEVIATION|2.83|<|0.05|TWO_SIDED|95.0|-5.95|-0.01|||Paired t-test|||||-0.01|-5.95|<0.05
91518093|NCT04575467|182910466|SUPERIORITY||Mean absolute fat volume difference|-114.4|STANDARD_DEVIATION|54.88|<|0.01|TWO_SIDED|95.0|-171.99|-56.81|||Paired t-test|||||-56.81|-171.99|<0.01
91518094|NCT04575467|182910466|SUPERIORITY||Mean absolute fat volume difference|-155.2|STANDARD_DEVIATION|64.7|<|0.01|TWO_SIDED|95.0|-223.1|-87.3|||Paired t-test|||||-87.30|-223.10|<0.01
91518095|NCT04575467|182910466|SUPERIORITY||Mean absolute fat volume difference|-119.17|STANDARD_DEVIATION|113.11|<|0.05|TWO_SIDED|95.0|-237.86|-0.47|||Paired t-test|||||-0.47|-237.86|<0.05
91518096|NCT03336619|182910507|SUPERIORITY|||||||0.3765|||||||Gehan-Wilcoxon|Analysis used a Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.3765
91518097|NCT03336619|182910508|SUPERIORITY|||||||0.6331|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.6331
91518098|NCT03336619|182910509|SUPERIORITY|||||||0.7382|||||||Fisher Exact|||||||0.7382
91518099|NCT03336619|182910510|SUPERIORITY|||||||0.3236|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset to enrollment and influenza vaccination status.||||||0.3236
91518100|NCT03336619|182910511|SUPERIORITY|||||||0.0483|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.0483
91518101|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.1||||||95.0|-2.9|2.8||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||2.8|-2.9|
91518102|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|3.5||||||95.0|0.4|6.6||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.6|0.4|
91518103|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.6|9.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||9.7|4.6|
91518104|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|3.6||||||95.0|0.4|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.4|
91518105|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.4|10.0||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||10.0|4.4|
91518106|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|3.7||||||95.0|0.6|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.6|
91518107|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|0.4||||||95.0|-2.1|2.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||2.9|-2.1|
91518108|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.4||||||95.0|-2.7|1.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||1.9|-2.7|
91562554|NCT01837719|183013261|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.085|||||TWO_SIDED|90.0|0.925|1.273|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir cobicistat||1.273|0.925|
91562555|NCT01837719|183013261|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.937|1.154|||||Geometric mean ratio was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.154|0.937|
91562556|NCT01837719|183013261|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.784|||||TWO_SIDED|90.0|0.717|0.858|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||0.858|0.717|
91562557|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.983|1.057|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment A|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.057|0.983|
91562558|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.232||||||90.0|1.141|1.331|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.331|1.141|
91769235|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-10.0||||0.484|TWO_SIDED|95.0|-37.8|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||17.7|-37.8|0.484
91769236|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-57.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||37.3|-57.3|1.000
91562559|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.929|1.307|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.307|0.929|
91562560|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.127||||||90.0|1.017|1.248|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC.||1.248|1.017|
91562561|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.825|0.96|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and a light meal on the natural logarithms of exposure of cobicistat when given as an FDC||0.960|0.825|
91562562|NCT01837719|183013263|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T), and AUC(INF).|Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.982|1.058|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.058|0.982|
91562563|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|1.148|1.34|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.340|1.148|
91518109|NCT01680328|182910564|SUPERIORITY_OR_OTHER||Least Squares Mean|9.0||||||95.0|6.7|11.3||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.||11.3|6.7|
91562564|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.976|||||TWO_SIDED|90.0|0.886|1.075|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.075|0.886|
91562565|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.116|||||TWO_SIDED|90.0|1.012|1.231|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and fasted on the natural logarithms of exposure of cobicistat when given as an FDC.||1.231|1.012|
91562566|NCT01837719|183013263|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.904|||||TWO_SIDED|90.0|0.836|0.978|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and light meal on the natural logarithms of exposure of atazanavir when given as an FDC||0.978|0.836|
91562567|NCT01183013|183013276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1571||95.0|-0.41|0.07||The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.|ANCOVA|||Treatment comparisons are for fixed dose combination versus monotherapy.||0.07|-0.41|0.1571
91562568|NCT01183013|183013276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0016|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.14|-0.60|0.0016
91562569|NCT01183013|183013276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0006|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.18|-0.64|0.0006
91562570|NCT01183013|183013276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0003|TWO_SIDED|95.0|-0.67|-0.2|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.20|-0.67|0.0003
91562571|NCT01183013|183013276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.44|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.44|-0.91|<0.0001
91562572|NCT01183013|183013276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.66|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.66|-1.12|<0.0001
91562573|NCT01183013|183013277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.246||||0.4639||95.0|0.692|2.242|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.242|0.692|0.4639
91562574|NCT01183013|183013277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.746||||0.0546||95.0|0.989|3.083|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.083|0.989|0.0546
91562575|NCT01183013|183013277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.0254||95.0|1.083|3.345|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.345|1.083|0.0254
91562576|NCT01183013|183013277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.804||||0.0009||95.0|1.524|5.159|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.159|1.524|0.0009
91562577|NCT01183013|183013277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.429|||<|0.0001||95.0|2.947|10.001|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.001|2.947|<0.0001
91562578|NCT01183013|183013277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.614|||<|0.0001||95.0|5.187|17.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||17.821|5.187|<0.0001
91562579|NCT01183013|183013278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.126||||0.7359||95.0|0.565|2.243|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.243|0.565|0.7359
91562580|NCT01183013|183013278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.905||||0.0363||95.0|1.042|3.484|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.484|1.042|0.0363
91562581|NCT01183013|183013278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.269||||0.4039||95.0|0.726|2.217|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.217|0.726|0.4039
91562582|NCT01183013|183013278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0345||95.0|1.06|4.649|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.649|1.060|0.0345
91562583|NCT01183013|183013278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001||95.0|2.263|9.266|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||9.266|2.263|<0.0001
91562584|NCT01183013|183013278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.066|||<|0.0001||95.0|2.53|10.145|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.145|2.530|<0.0001
91562585|NCT01183013|183013279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.754||95.0|0.637|1.863|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.863|0.637|0.7540
91562586|NCT01183013|183013279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.707||||0.0506||95.0|0.999|2.918|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.918|0.999|0.0506
91562587|NCT01183013|183013279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.966||||0.0005|TWO_SIDED|95.0|1.604|5.485|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.485|1.604|0.0005
91562588|NCT01183013|183013279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0002||95.0|1.594|4.559|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.559|1.594|0.0002
91562589|NCT01183013|183013279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.017|||<|0.0001||95.0|2.348|6.873|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||6.873|2.348|<0.0001
91562590|NCT01183013|183013279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.521|||<|0.0001||95.0|4.63|15.681|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||15.681|4.630|<0.0001
91562591|NCT01183013|183013281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68||||0.4275|TWO_SIDED|95.0|-12.77|5.42|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.42|-12.77|0.4275
91562592|NCT01183013|183013281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.6839|TWO_SIDED|95.0|-10.69|7.02|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||7.02|-10.69|0.6839
91562593|NCT01183013|183013281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.1466|TWO_SIDED|95.0|-15.29|2.28|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.28|-15.29|0.1466
91562594|NCT01183013|183013281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.38||||0.0002|TWO_SIDED|95.0|-26.35|-8.41|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-8.41|-26.35|0.0002
91562595|NCT01183013|183013281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.87|||<|0.0001|TWO_SIDED|95.0|-34.77|-16.98|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-16.98|-34.77|<0.0001
91562596|NCT01183013|183013281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||<|0.0001|TWO_SIDED|95.0|-42.57|-24.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-24.89|-42.57|<0.0001
91562597|NCT01183013|183013283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.61||||0.0057|TWO_SIDED|95.0|-62.42|-10.8|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-10.80|-62.42|0.0057
91562598|NCT01183013|183013283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.94||||0.7021||95.0|-30.39|20.51|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||20.51|-30.39|0.7021
91562599|NCT01183013|183013283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.8932|TWO_SIDED|95.0|-27.95|24.38|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||24.38|-27.95|0.8932
91562600|NCT01183013|183013283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.2706|TWO_SIDED|95.0|-43.6|12.3|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||12.30|-43.60|0.2706
91562601|NCT01183013|183013283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.33||||0.0126|TWO_SIDED|95.0|-64.78|-7.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-7.89|-64.78|0.0126
91562602|NCT01183013|183013283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.16||||0.0167|TWO_SIDED|95.0|-60.23|-6.08|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-6.08|-60.23|0.0167
91562603|NCT01183013|183013285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.649||||0.3052||95.0|0.284|1.482|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.482|0.284|0.3052
91562604|NCT01183013|183013285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.456||||0.0844|TWO_SIDED|95.0|0.187|1.112|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.112|0.187|0.0844
91562605|NCT01183013|183013285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.443||||0.1561|TWO_SIDED|95.0|0.143|1.365|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.365|0.143|0.1561
91562606|NCT01183013|183013285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.368||||0.0146||95.0|0.165|0.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.821|0.165|0.0146
91562607|NCT01183013|183013285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.238||||0.0009||95.0|0.102|0.557|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.557|0.102|0.0009
91769237|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-11.2||||0.431|TWO_SIDED|95.0|-38.9|16.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||16.5|-38.9|0.431
91769238|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-20.7||||0.25|TWO_SIDED|95.0|-48.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||7.1|-48.5|0.250
91769239|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-40.9|50.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||50.9|-40.9|1.000
91769240|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-25.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||23.3|-25.2|1.000
91769241|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-5.7||||1|TWO_SIDED|95.0|-31.1|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||19.6|-31.1|1.000
91769242|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||55.2|-35.2|0.544
91769243|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||20.9|-22.4|1.000
91769244|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-7.9||||0.627|TWO_SIDED|95.0|-28.5|12.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||12.8|-28.5|0.627
91769245|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
91518110|NCT01680328|182910565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.5|1.4|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.4|0.5|
91562608|NCT01183013|183013285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.0002||95.0|0.05|0.397|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.397|0.050|0.0002
91562609|NCT01951105|183013293|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91769246|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||17.7|-18.7|1.000
91769247|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|4.3||||1|TWO_SIDED|95.0|-18.3|26.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||26.8|-18.3|1.000
91769248|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|14.3||||0.232|TWO_SIDED|95.0|-0.7|29.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||29.3|-0.7|0.232
91518111|NCT01680328|182910565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.2|3.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.5|1.2|
91769249|NCT02365649|183425734|SUPERIORITY||Risk Difference (RD)|7.1||||0.412|TWO_SIDED|95.0|-6.3|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||20.6|-6.3|0.412
91769250|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-745.7||||0.356|TWO_SIDED|95.0|-2369.73|878.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||878.37|-2369.73|0.356
91769251|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-1119.5||||0.158|TWO_SIDED|95.0|-2698.52|459.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||459.50|-2698.52|0.158
91769252|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-1166.0||||0.322|TWO_SIDED|95.0|-3531.3|1199.32||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||1199.32|-3531.30|0.322
91769253|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-828.2||||0.287|TWO_SIDED|95.0|-2387.16|730.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||730.75|-2387.16|0.287
91769254|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-1286.1||||0.088|TWO_SIDED|95.0|-2772.59|200.43||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Responders, Week 52||200.43|-2772.59|0.088
91769255|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-502.2||||0.613|TWO_SIDED|95.0|-2505.74|1501.38||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||1501.38|-2505.74|0.613
91769256|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|283.4||||0.609|TWO_SIDED|95.0|-823.64|1390.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1390.49|-823.64|0.609
91769257|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-78.2||||0.855|TWO_SIDED|95.0|-930.47|774.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||774.16|-930.47|0.855
91769258|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|283.5||||0.584|TWO_SIDED|95.0|-751.66|1318.57||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1318.57|-751.66|0.584
91769259|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|356.6||||0.624|TWO_SIDED|95.0|-1095.03|1808.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1808.19|-1095.03|0.624
91562610|NCT05072795|183013297|OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
91769260|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-135.1||||0.806|TWO_SIDED|95.0|-1233.48|963.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||963.25|-1233.48|0.806
91769261|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|186.2||||0.793|TWO_SIDED|95.0|-1229.59|1602.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1602.06|-1229.59|0.793
91769262|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-304.8||||0.561|TWO_SIDED|95.0|-1350.04|740.44||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||740.44|-1350.04|0.561
91769263|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-1119.0||||0.024|TWO_SIDED|95.0|-2083.81|-154.11||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 28||-154.11|-2083.81|0.024
91769264|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-819.3||||0.156|TWO_SIDED|95.0|-1959.79|321.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||321.21|-1959.79|0.156
91769265|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-346.6||||0.58|TWO_SIDED|95.0|-1592.66|899.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||899.45|-1592.66|0.580
91769266|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-1275.9||||0.029|TWO_SIDED|95.0|-2415.88|-135.92||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 52||-135.92|-2415.88|0.029
91769267|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-534.9||||0.431|TWO_SIDED|95.0|-1883.23|813.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||813.50|-1883.23|0.431
91769268|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|-25.4||||0.965|TWO_SIDED|95.0|-1200.67|1149.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1149.95|-1200.67|0.965
91769269|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|623.6||||0.123|TWO_SIDED|95.0|-183.52|1430.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1430.64|-183.52|0.123
91769270|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|368.2||||0.591|TWO_SIDED|95.0|-1031.23|1767.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1767.60|-1031.23|0.591
91769271|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|192.2||||0.642|TWO_SIDED|95.0|-648.22|1032.68||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1032.68|-648.22|0.642
91769272|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|455.8||||0.093|TWO_SIDED|95.0|-81.37|992.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical non-responders, Week 52||992.95|-81.37|0.093
91769273|NCT02365649|183425735|SUPERIORITY||LS Mean of Difference|463.6||||0.296|TWO_SIDED|95.0|-428.99|1356.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1356.20|-428.99|0.296
91769274|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-2.0||||0.822|TWO_SIDED|95.0|-19.83|15.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||15.83|-19.83|0.822
91769275|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-6.4||||0.386|TWO_SIDED|95.0|-20.97|8.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||8.25|-20.97|0.386
91769276|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|12.9||||0.136|TWO_SIDED|95.0|-4.22|29.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||29.95|-4.22|0.136
91562611|NCT00422162|183013298|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value for Change from Baseline. A priori alpha threshold was 0.05 with no adjustment for multiple testing.|ANCOVA|ANCOVA with stratification factors (country and pretreatment for MDD) and MADRS baseline as covariates and treatment regimen as the main factor.||||||0.88
91562612|NCT00422162|183013308|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
91562613|NCT00422162|183013308|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.001
91562614|NCT00422162|183013308|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
91562615|NCT00422162|183013308|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.28
91562616|NCT02971683|183013338|SUPERIORITY||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.9|3.5|||Regression, Logistic|||||3.5|0.9|0.083
91562617|NCT02907489|183013352|SUPERIORITY|||||||0.083||||||0.083 for 24 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.083
91562618|NCT02907489|183013352|SUPERIORITY|||||||0.041||||||0.041 for 48 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.041
91562619|NCT02907489|183013352|SUPERIORITY|||||||0.063||||||0.063 for 72 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.063
91562620|NCT02907489|183013353|SUPERIORITY|||||||0.982||||||0.982 for S1, Significant at P ≤ 0.05|Chi-squared|||||||0.982
91562621|NCT02907489|183013353|SUPERIORITY|||||||0.467||||||0.467 for S2, Significant at P ≤ 0.05|Chi-squared|||||||0.467
91562622|NCT02907489|183013353|SUPERIORITY|||||||0.01||||||0.01 for S3 Significant at P ≤ 0.05|Chi-squared|||||||0.01
91769277|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|1.0||||0.912|TWO_SIDED|95.0|-17.87|19.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||19.97|-17.87|0.912
91769278|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-12.3||||0.118|TWO_SIDED|95.0|-27.77|3.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||3.25|-27.77|0.118
91769279|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|12.5||||0.171|TWO_SIDED|95.0|-5.61|30.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||30.65|-5.61|0.171
91769280|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-6.9||||0.479|TWO_SIDED|95.0|-26.5|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||12.63|-26.50|0.479
91769281|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-17.1||||0.037|TWO_SIDED|95.0|-33.12|-1.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders, Week 36||-1.04|-33.12|0.037
91769282|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|6.9||||0.463|TWO_SIDED|95.0|-11.86|25.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||25.65|-11.86|0.463
91769283|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-4.6||||0.627|TWO_SIDED|95.0|-23.59|14.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||14.37|-23.59|0.627
91769284|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-12.2||||0.122|TWO_SIDED|95.0|-27.75|3.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||3.37|-27.75|0.122
91769285|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|10.7||||0.243|TWO_SIDED|95.0|-7.49|28.89||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||28.89|-7.49|0.243
91769286|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-4.2||||0.658|TWO_SIDED|95.0|-22.95|14.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||14.63|-22.95|0.658
91769287|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-12.3||||0.115|TWO_SIDED|95.0|-27.69|3.12||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||3.12|-27.69|0.115
91769288|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|10.0||||0.267|TWO_SIDED|95.0|-7.96|28.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||28.06|-7.96|0.267
91769289|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.2||||0.974|TWO_SIDED|95.0|-9.74|10.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||10.06|-9.74|0.974
91769290|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.5||||0.882|TWO_SIDED|95.0|-7.61|6.55||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||6.55|-7.61|0.882
91769291|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.1||||0.982|TWO_SIDED|95.0|-7.92|7.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||7.75|-7.92|0.982
91769292|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|2.2||||0.673|TWO_SIDED|95.0|-8.11|12.51||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||12.51|-8.11|0.673
91769293|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|2.7||||0.467|TWO_SIDED|95.0|-4.64|10.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.04|-4.64|0.467
91518112|NCT01680328|182910565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.4|3.0||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.0|1.4|
91562623|NCT00912964|183013356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.005|TWO_SIDED|95.0|-0.74|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.74|0.005
91562624|NCT00912964|183013356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|95.0|-0.76|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.76|0.001
91562625|NCT00912964|183013357|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.15|TWO_SIDED|95.0|-1.6|10.8||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||10.8|-1.6|0.15
91562626|NCT00912964|183013357|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.4|||<|0.001|TWO_SIDED|95.0|6.3|18.6||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.6|6.3|<0.001
91562627|NCT00912964|183013358|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.82|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.82|0.007
91562628|NCT00912964|183013358|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.015|TWO_SIDED|95.0|-0.76|-0.08||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.08|-0.76|0.015
91562629|NCT00912964|183013359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.039|TWO_SIDED|95.0|-0.68|-0.01||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.01|-0.68|0.039
91562630|NCT00912964|183013359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.85|-0.17||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.17|-0.85|<0.001
91769294|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|2.2||||0.583|TWO_SIDED|95.0|-5.79|10.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.23|-5.79|0.583
91562631|NCT00912964|183013360|SUPERIORITY_OR_OTHER_LEGACY||LS Difference|-0.18||||0.3|TWO_SIDED|95.0|-0.53|0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.16|-0.53|0.30
91562632|NCT00912964|183013360|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.37||||0.035|TWO_SIDED|95.0|-0.71|-0.03||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.03|-0.71|0.035
91562633|NCT00912964|183013361|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.07||||0.083|TWO_SIDED|95.0|-0.15|0.01||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.01|-0.15|0.083
91562634|NCT00912964|183013361|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.22|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.22|<0.001
91562635|NCT00912964|183013362|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36||||0.004|TWO_SIDED|95.0|-0.67|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.67|0.004
91562636|NCT00912964|183013362|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.69|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.69|0.002
91562637|NCT00912964|183013363|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.13|TWO_SIDED|95.0|-0.76|0.1||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.10|-0.76|0.13
91562638|NCT00912964|183013363|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59||||0.007|TWO_SIDED|95.0|-1.01|-0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.16|-1.01|0.007
91562639|NCT03905512|183013400|SUPERIORITY|Statistical significance was tested at a level of 0.05.||||||0.181|||||||Cochran-Mantel-Haenszel|||||||0.181
91562640|NCT03293238|183013419|SUPERIORITY|||||||0.527|||||||ANOVA|||||||0.527
91562641|NCT03293238|183013420|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
91562642|NCT02138838|183013449|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|8.1||||0.48|TWO_SIDED|95.0|-13.7|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||29.9|-13.7|0.48
91769295|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|5.5||||0.564|TWO_SIDED|95.0|-13.33|24.31||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||24.31|-13.33|0.564
91769296|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-2.4||||0.728|TWO_SIDED|95.0|-15.74|11.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||11.04|-15.74|0.728
91562643|NCT02138838|183013450|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-9.9||||0.42|TWO_SIDED|95.0|-33.3|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by baseline age group (6-\<12 years, 12-\<18 years)|SOC+Cinacalcet - SOC|A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm's method at 0.05 (2-sided) should the primary endpoint achieve a significant result.||13.4|-33.3|0.42
91562644|NCT02138838|183013451|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-10.4||||0.25|TWO_SIDED|95.0|-27.7|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||6.8|-27.7|0.25
91562645|NCT02138838|183013452|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.0||||0.23|TWO_SIDED|95.0|-12.5|50.5|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||50.5|-12.5|0.23
91562646|NCT02138838|183013453|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.34||||0.059|TWO_SIDED|95.0|-0.7|0.01|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.||||0.01|-0.70|0.059
91562647|NCT02138838|183013454|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.76||||0.039|TWO_SIDED|95.0|0.04|1.48|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||1.48|0.04|0.039
91562648|NCT01294644|183013460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.52|4.43|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||4.43|1.52|<0.001
91562649|NCT01294644|183013460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.83|5.36|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.36|1.83|<0.001
91562650|NCT01294644|183013461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.02|TWO_SIDED|95.0|1.48|92.67|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||92.67|1.48|0.020
91769297|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|5.5||||0.46|TWO_SIDED|95.0|-9.16|20.08||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||20.08|-9.16|0.460
91562651|NCT01294644|183013461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53||||0.021|TWO_SIDED|95.0|1.46|91.24|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||91.24|1.46|0.021
91562652|NCT01294644|183013462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.37|||<|0.001|TWO_SIDED|95.0|3.06|9.44|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model.|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.44|3.06|<0.001
91562653|NCT01294644|183013462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.001|TWO_SIDED|95.0|2.65|8.04|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.04|2.65|<0.001
91562654|NCT01294644|183013463|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline CR-SMFRS values as covariate.||||-0.19|-0.51|<0.001
91562655|NCT01294644|183013463|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.56|-0.24|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.24|-0.56|<0.001
91562656|NCT01294644|183013464|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.75|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.75|0.97|<0.001
91562657|NCT01294644|183013464|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|||<|0.001|TWO_SIDED|95.0|0.87|1.65|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.65|0.87|<0.001
91562658|NCT01294644|183013465|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.09|TWO_SIDED|95.0|-1.72|0.13|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||0.13|-1.72|0.090
91562659|NCT01294644|183013465|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97||||0.04|TWO_SIDED|95.0|-1.89|-0.05|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.05|-1.89|0.040
91562660|NCT01294644|183013466|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Pearson's chi-square test|||||||0.009
91769298|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|12.0||||0.253|TWO_SIDED|95.0|-8.72|32.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||32.75|-8.72|0.253
91769299|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|1.1||||0.884|TWO_SIDED|95.0|-13.67|15.84||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||15.84|-13.67|0.884
91562661|NCT01294644|183013466|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Pearson's chi-square test|||||||0.001
91562662|NCT04520256|183013478|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91562663|NCT04520256|183013479|SUPERIORITY||Estimated Change|-0.27||||0.693|TWO_SIDED|95.0|-0.54|0.01|||Mixed Models Analysis|||||0.01|-.54|0.693
91562664|NCT04520256|183013479|SUPERIORITY||Estimated Change|0.09||||0.9|TWO_SIDED|95.0|0.01|0.18|||Mixed Models Analysis|||||0.18|0.01|0.900
91562665|NCT04520256|183013479|SUPERIORITY||Estimated Change|-0.03||||0.96|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||||0.01|-0.06|0.960
91562666|NCT04520256|183013479|SUPERIORITY||Estimated Change|0.44||||0.113|TWO_SIDED|95.0|0.01|0.88|||Mixed Models Analysis|||||0.88|0.01|0.113
91562667|NCT04520256|183013479|SUPERIORITY||Estimated Change|0.92||||0.187|TWO_SIDED|95.0|0.01|1.84|||Mixed Models Analysis|||||1.84|0.01|0.187
91562668|NCT04520256|183013480|SUPERIORITY|||||||0.999|||||||Mixed Models Analysis|||||||0.999
91562669|NCT04520256|183013481|SUPERIORITY||Estimated Proportion|0.12||||0.999|TWO_SIDED|95.0|0.0|0.56|||Mixed Models Analysis|||||.56|0|.999
91562670|NCT04520256|183013481|SUPERIORITY||Estimated Proportion|0.15||||0.999|TWO_SIDED|95.0|0.0|0.68|||Mixed Models Analysis|||||.68|0|.999
91562671|NCT04520256|183013481|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.52|||Mixed Models Analysis|||||.52|0|.999
91562672|NCT04520256|183013481|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||||.50|0|.999
91562673|NCT04520256|183013481|SUPERIORITY||Estimated Proportion|0.1||||0.999|TWO_SIDED|95.0|0.0|0.47|||Mixed Models Analysis|||||.47|0|.999
91562674|NCT03512041|183013536|SUPERIORITY|||||||0.172|||||||ANOVA|||||||0.172
91562675|NCT03512041|183013537|SUPERIORITY|||||||0.169|||||||ANOVA|||||||0.169
91769300|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|5.8||||0.474|TWO_SIDED|95.0|-10.28|21.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||21.95|-10.28|0.474
91562676|NCT03512041|183013538|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
91562677|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562678|NCT02069366|183013539|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
91562679|NCT02069366|183013539|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U)||||0.040
91562680|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562681|NCT02069366|183013539|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
91562682|NCT02069366|183013539|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus time factors.||This analysis corresponds to the row 'Extinction Learning CS- vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.040
91562683|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562684|NCT02069366|183013539|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
91562685|NCT02069366|183013539|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
91562686|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562687|NCT02069366|183013539|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
91769301|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|3.6||||0.727|TWO_SIDED|95.0|-17.03|24.3||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||24.30|-17.03|0.727
91562688|NCT02069366|183013539|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
91562689|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562690|NCT02069366|183013539|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
91562691|NCT02069366|183013539|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
91562692|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562693|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Hippocampus- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562694|NCT02069366|183013539|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E vmPFC- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
91562695|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91769302|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|2.1||||0.78|TWO_SIDED|95.0|-12.63|16.78||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||16.78|-12.63|0.780
91562696|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562697|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562698|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562699|NCT02069366|183013539|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
91562700|NCT02069366|183013539|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
91562701|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562702|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562703|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS-Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562704|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562705|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91769303|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|6.5||||0.424|TWO_SIDED|95.0|-9.57|22.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||22.54|-9.57|0.424
91769304|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-1.3||||0.841|TWO_SIDED|95.0|-14.23|11.62||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||11.62|-14.23|0.841
91769305|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-2.1||||0.702|TWO_SIDED|95.0|-12.94|8.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||8.75|-12.94|0.702
91769306|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|5.7||||0.353|TWO_SIDED|95.0|-6.43|17.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||17.83|-6.43|0.353
91769307|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|2.1||||0.77|TWO_SIDED|95.0|-11.89|16.0||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||16.00|-11.89|0.770
91769308|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-5.3||||0.367|TWO_SIDED|95.0|-17.04|6.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||6.37|-17.04|0.367
91769309|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|7.0||||0.291|TWO_SIDED|95.0|-6.09|20.07||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||20.07|-6.09|0.291
91769310|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.7||||0.942|TWO_SIDED|95.0|-20.87|19.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||19.40|-20.87|0.942
91769311|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-12.0||||0.162|TWO_SIDED|95.0|-28.89|4.91||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||4.91|-28.89|0.162
91769312|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|10.9||||0.253|TWO_SIDED|95.0|-7.96|29.82||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||29.82|-7.96|0.253
91769313|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|5.5||||0.617|TWO_SIDED|95.0|-16.25|27.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||27.21|-16.25|0.617
91769314|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-6.0||||0.515|TWO_SIDED|95.0|-24.22|12.24||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||12.24|-24.22|0.515
91769315|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|13.8||||0.18|TWO_SIDED|95.0|-6.53|34.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||34.23|-6.53|0.180
91769316|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.4||||0.972|TWO_SIDED|95.0|-21.86|21.09||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||21.09|-21.86|0.972
91769317|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-4.9||||0.589|TWO_SIDED|95.0|-22.94|13.1||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||13.10|-22.94|0.589
91769318|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|14.1||||0.168|TWO_SIDED|95.0|-6.07|34.22||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||34.22|-6.07|0.168
91769319|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|1.9||||0.712|TWO_SIDED|95.0|-8.5|12.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||12.36|-8.50|0.712
91769320|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-2.3||||0.465|TWO_SIDED|95.0|-8.41|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||3.90|-8.41|0.465
91769321|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.3||||0.924|TWO_SIDED|95.0|-6.83|7.52||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||7.52|-6.83|0.924
91562706|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS- Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562707|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562708|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562709|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Late-Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562710|NCT02069366|183013540|SUPERIORITY|||||||0.04||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Late- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.04
91562711|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562712|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562713|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562714|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562715|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562716|NCT02069366|183013540|SUPERIORITY|||||||0.033||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.033
91562717|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562718|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562719|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562720|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562721|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562722|NCT02069366|183013540|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
91562723|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Pre- Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562724|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Mid-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562725|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Post-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562726|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562727|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562728|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562729|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562730|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91769322|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.4||||0.938|TWO_SIDED|95.0|-8.88|9.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||9.60|-8.88|0.938
91562731|NCT02069366|183013541|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
91562732|NCT00168805|183013552|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-1.3||||0.6648||95.0|-7.3|4.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.6|-7.3|0.6648
91562733|NCT00168805|183013552|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|2.8||||0.3553||95.0|-3.1|8.7||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.7|-3.1|0.3553
91562734|NCT00168805|183013553|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.0||||0.376||95.0|-3.1|1.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.2|-3.1|0.3760
91562735|NCT00168805|183013553|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.8151||95.0|-2.0|2.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.6|-2.0|0.8151
91562736|NCT00168805|183013554|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.4715||95.0|-2.8|1.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.3|-2.8|0.4715
91562737|NCT00168805|183013554|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.9325||95.0|-2.1|2.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.3|-2.1|0.9325
91562738|NCT00168805|183013555|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.4||||0.6463||95.0|-7.3|4.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.5|-7.3|0.6463
91562739|NCT00168805|183013555|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|2.7||||0.374||95.0|-3.2|8.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.6|-3.2|0.3740
91562740|NCT00168805|183013556|SUPERIORITY_OR_OTHER|||||||0.0385||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0385
91562741|NCT00168805|183013556|SUPERIORITY_OR_OTHER|||||||0.1414||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1414
91562742|NCT00168805|183013557|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91562743|NCT00168805|183013557|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91562744|NCT00168805|183013558|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91562745|NCT00168805|183013558|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91562746|NCT00168805|183013560|SUPERIORITY_OR_OTHER|||||||0.8209||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.8209
91562747|NCT00168805|183013560|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
91562748|NCT02995733|183013564|SUPERIORITY|Asthma exacerbation rates during follow-up between two randomized treatment arms are compared using the Andersen-Gill adaptation of time-to-event Cox proportional hazard model with robust standard errors to account for multiple occurrences of the outcome in each patient (Andersen Gill, 1982). This analysis is based on intention-to-treat (ITT) patient population.|Cox Proportional Hazard|0.85||||0.048|TWO_SIDED|95.0|0.72|0.999|||Cox proportional hazard model|Pre-specified baseline covariates are adjusted in the model. A time-dependent covariate for the COVID pandemic is also included in adjustments.||||0.999|0.720|0.048
91769323|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|2.2||||0.41|TWO_SIDED|95.0|-3.17|7.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||7.64|-3.17|0.410
91562749|NCT02995733|183013565|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ACT change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
91562750|NCT02995733|183013566|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ASUI change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.05||||||||0.05|0.02|
91562751|NCT02995733|183013567|SUPERIORITY|Negative binomial regression model is used, with time as an offset to account for differential duration of follow-up. The model adjusts for all the baseline covariates included in the primary analysis.|Rate ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||||0.95|0.67|
91562752|NCT04468633|183013572|OTHER|||||||0.687|||||||t-test, 2 sided|||Baseline||||0.687
91562753|NCT04468633|183013572|OTHER|||||||0.384|||||||t-test, 2 sided|||Day 1||||0.384
91769324|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.2||||0.941|TWO_SIDED|95.0|-5.89|6.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||6.35|-5.89|0.941
91769325|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.7||||0.872|TWO_SIDED|95.0|-8.23|9.67||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||9.67|-8.23|0.872
91562754|NCT04468633|183013572|OTHER|||||||0.597|||||||t-test, 2 sided|||Week 1||||0.597
91562755|NCT04468633|183013572|OTHER|||||||0.86|||||||t-test, 2 sided|||Week 4||||0.860
91769326|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-1.0||||0.692|TWO_SIDED|95.0|-6.27|4.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||4.20|-6.27|0.692
91562756|NCT04468633|183013572|OTHER|||||||0.032|||||||t-test, 2 sided|||Week 6||||0.032
91562757|NCT04468633|183013572|OTHER|||||||0.026|||||||t-test, 2 sided|||Month 3||||0.026
91562758|NCT04468633|183013572|OTHER|||||||0.172|||||||t-test, 2 sided|||Month 6||||0.172
91562759|NCT04468633|183013572|OTHER|||||||0.01|||||||t-test, 2 sided|||Year 1||||0.010
91518113|NCT01680328|182910565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.8|1.4|
91562760|NCT04468633|183013576|OTHER|||||||0.759|||||||Wilcoxon rank sum test|||||||0.759
91562761|NCT04468633|183013577|OTHER|||||||0.603|||||||Wilcoxon rank sum test|||||||0.603
91562762|NCT04468633|183013586|OTHER|||||||0.833|||||||Wilcoxon rank sum test|||||||0.833
91562763|NCT04739306|183013604|EQUIVALENCE|Predefined equivalence margin: -3 letters to +3 letters|Estimated difference in LS means|0.58|||||TWO_SIDED|90.0|-0.52|1.67|||ANCOVA|Analysis conducted for study eye. Primary endpoint as the dependent variable, treatment as a factor, baseline BCVA and country as covariates.||||1.67|-0.52|
91562764|NCT01469819|183013646|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91562765|NCT01469819|183013647|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91562766|NCT01469819|183013648|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91562767|NCT01469819|183013649|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91562768|NCT01403805|183013657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Fisher's test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'|Fisher Exact|||The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||<0.001
91562769|NCT01403805|183013658|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||0.05
91562770|NCT03082196|183013664|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.037|TWO_SIDED|95.0|-1.9|-0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||-0.1|-1.9|0.037
91562771|NCT03082196|183013665|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.062|TWO_SIDED|95.0|-1.5|0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||0.1|-1.5|0.062
91562772|NCT03082196|183013666|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.11|TWO_SIDED|95.0|-0.5|0.1|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a happier response in the test varnish as compared to the standard varnish."|||0.1|-0.5|0.11
91562773|NCT03082196|183013667|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A positive value for the difference indicates an unhappier response in the test varnish as compared to the standard varnish."|||0.3|-0.2|0.74
91769327|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.4||||0.896|TWO_SIDED|95.0|-6.32|5.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||5.54|-6.32|0.896
91562774|NCT01695993|183013668|OTHER|Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.|Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.9||0.05|TWO_SIDED|||||Not adjusted|ANCOVA|||||||.05
91562775|NCT00472199|183013669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0077||95.0|-4.6|-0.7|||ANCOVA|||Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate||-0.7|-4.6|0.0077
91562776|NCT00472199|183013670|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0010
91562777|NCT00472199|183013671|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||Cochran-Mantel-Haenszel|||||||0.0044
91562778|NCT00472199|183013672|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|||||||0.0011
91562779|NCT00472199|183013673|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.0489||95.0|-1.1|-0.9|||Wilcoxon (Mann-Whitney)|||||-0.9|-1.1|0.0489
91518114|NCT01680328|182910565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.6||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.6|1.4|
91562780|NCT00472199|183013674|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0315|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0315
91562781|NCT00472199|183013675|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0735|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0735
91562782|NCT00472199|183013676|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.841|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8410
91562783|NCT00472199|183013677|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9241|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.9241
91562784|NCT00472199|183013678|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8093|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8093
91562785|NCT00472199|183013679|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0583|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0583
91562786|NCT00472199|183013680|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0||||0.0916|TWO_SIDED|95.0|-5.5|-4.5|||Wilcoxon (Mann-Whitney)|||||-4.5|-5.5|0.0916
91562787|NCT00472199|183013681|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.5905|TWO_SIDED|95.0|2.2|2.8|||Wilcoxon (Mann-Whitney)|||||2.8|2.2|0.5905
91562788|NCT00472199|183013682|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.0179|TWO_SIDED|95.0|1.6|2.4|||Wilcoxon (Mann-Whitney)|||||2.4|1.6|0.0179
91562789|NCT00472199|183013683|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.545|TWO_SIDED|95.0|1.7|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|1.7|0.5450
91562790|NCT00472199|183013684|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1456|TWO_SIDED|95.0|-0.3|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-0.3|0.1456
91562791|NCT00472199|183013685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2915|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.2915
91562792|NCT00472199|183013686|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3131|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.3131
91562793|NCT00472199|183013687|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5713|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.5713
91562794|NCT00472199|183013688|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8432|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.8432
91562795|NCT00472199|183013689|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.0206|TWO_SIDED|95.0|5.9|6.6|||Wilcoxon (Mann-Whitney)|||||6.6|5.9|0.0206
91562796|NCT00472199|183013690|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.5602|TWO_SIDED|95.0|0.4|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|0.4|0.5602
91562797|NCT00472199|183013691|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.136|TWO_SIDED|95.0|0.8|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|0.8|0.1360
91562798|NCT00472199|183013693|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Mantel Haenszel|||||||0.0022
91562799|NCT01601821|183013710|SUPERIORITY_OR_OTHER||percent difference|-2.0||||0.341|TWO_SIDED|90.0|-5.5|1.5|||Chi-squared|||Chi-square test was used to test superiority of arm CsA+Rapamune+CS versus arm CsA+MMF+CS.||1.5|-5.5|0.341
91562800|NCT01601821|183013711|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way analysis of variance (ANOVA) was used to test the difference.||||0.870
91562801|NCT01601821|183013711|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.381
91562802|NCT01601821|183013711|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.096
91562803|NCT01601821|183013712|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.979
91562804|NCT01601821|183013712|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.660
91562805|NCT01601821|183013712|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.518
91562806|NCT01601821|183013713|SUPERIORITY_OR_OTHER|||||||0.786|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.786
91562807|NCT01601821|183013713|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.738
91562808|NCT01601821|183013713|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.977
91562809|NCT01601821|183013714|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
91562810|NCT01601821|183013716|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.276
91562811|NCT01601821|183013717|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
91562812|NCT01601821|183013718|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.868
91562813|NCT01601821|183013719|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
91562814|NCT01601821|183013720|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.985
91562815|NCT01601821|183013721|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.172
91562816|NCT01601821|183013722|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.978
91562817|NCT00848198|183013742|SUPERIORITY_OR_OTHER||Sensitivity|87.1|||||TWO_SIDED|95.0|83.2|90.9||||||||90.9|83.2|
91562818|NCT00848198|183013742|SUPERIORITY_OR_OTHER||Specificity|72.0|||||TWO_SIDED|95.0|66.9|77.1||||||||77.1|66.9|
91562819|NCT00848198|183013743|SUPERIORITY_OR_OTHER||Sensitivity|39.7|||||TWO_SIDED|95.0|34.2|45.3||||||||45.3|34.2|
91562820|NCT00848198|183013743|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
91562821|NCT00848198|183013744|SUPERIORITY_OR_OTHER||Sensitivity|71.9|||||TWO_SIDED|95.0|66.8|77.0||||||||77.0|66.8|
91562822|NCT00848198|183013744|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
91562823|NCT00848198|183013745|SUPERIORITY_OR_OTHER||Sensitivity|27.2|||||TWO_SIDED|95.0|22.2|32.3||||||||32.3|22.2|
91562824|NCT00848198|183013745|SUPERIORITY_OR_OTHER||Specificity|98.7|||||TWO_SIDED|95.0|97.4|100.0||||||||100.0|97.4|
91562825|NCT00848198|183013746|SUPERIORITY_OR_OTHER||Sensitivity|51.3|||||TWO_SIDED|95.0|45.7|57.0||||||||57.0|45.7|
91562826|NCT00848198|183013746|SUPERIORITY_OR_OTHER||Specificity|94.7|||||TWO_SIDED|95.0|92.1|97.2||||||||97.2|92.1|
91562827|NCT00848198|183013747|SUPERIORITY_OR_OTHER||Sensitivity|61.2|||||TWO_SIDED|95.0|55.6|66.7||||||||66.7|55.6|
91562828|NCT00848198|183013747|SUPERIORITY_OR_OTHER||Specificity|78.7|||||TWO_SIDED|95.0|74.0|83.3||||||||83.3|74.0|
91562829|NCT00848198|183013748|SUPERIORITY_OR_OTHER||Sensitivity|58.5|||||TWO_SIDED|95.0|52.9|64.1||||||||64.1|52.9|
91562830|NCT00848198|183013748|SUPERIORITY_OR_OTHER||Specificity|73.3|||||TWO_SIDED|95.0|68.3|78.3||||||||78.3|68.3|
91562831|NCT02342275|183013796|NON_INFERIORITY|Assuming that the atenolol on the propranolol response rate does not fall by greater than 15%, the noninferiority margin was selected to be -15%.|Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||Treatment Difference=Propranolol vs Atenolol|The sample size required to compare propranolol and atenolol at month 6 was calculated before enrollment. Assuming the ulceration rate in both groups to be 10%, a sample size of180 patients was required for each group to show the noninferiority ofatenolol treatment with a 2-sidedα level of .05 and approximately 90% power||||<0.05
91562832|NCT02213458|183013802|SUPERIORITY||Slope|0.539||||0.04|TWO_SIDED|95.0|0.259|1.337|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||Linear mixed effects model||1.337|.259|0.04
91562833|NCT02213458|183013803|SUPERIORITY||Slope|-0.138||||0.05|TWO_SIDED|95.0|-0.295|-0.02|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-.020|-.295|.05
91562834|NCT02213458|183013804|SUPERIORITY||Slope|-1.902||||0.07|TWO_SIDED|95.0|-3.885|-0.08|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-0.080|-3.885|0.07
91562835|NCT02213458|183013806|SUPERIORITY||Slope|-1.143||||0.03|TWO_SIDED|95.0|-2.154|-0.132|||Mixed Models Analysis|||||-0.132|-2.154|0.03
91562836|NCT02213458|183013807|SUPERIORITY||Slope|0.635||||0.11|TWO_SIDED|95.0|-0.135|1.405|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||||1.405|-0.135|0.11
91562837|NCT01357564|183013819|SUPERIORITY||Mean Difference (Net)|-0.72||||0.02|TWO_SIDED|95.0|-1.23|-0.13|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.13|-1.23|.02
91518115|NCT01680328|182910565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.7|1.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.5|0.7|
91518116|NCT01680328|182910566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.7|1.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.8|0.7|
91518117|NCT01680328|182910566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||||95.0|0.6|1.2||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.2|0.6|
91518118|NCT01680328|182910567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7||||||95.0|2.4|5.5|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition.||5.5|2.4|
91518119|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
91518120|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.4||||||95.0|-0.8|1.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.6|-0.8|
91518121|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.4|
91518122|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
91518123|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
91518124|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.7|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.7|
91518125|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.3|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.3|
91518126|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.0||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.0|-0.4|
91518127|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.1||||||95.0|-0.1|2.3||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.3|-0.1|
91518128|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||||95.0|1.0|3.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||3.5|1.0|
91518129|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.4||||||95.0|0.2|2.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.6|0.2|
91518130|NCT01680328|182910568|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
91518131|NCT01680328|182910569|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.3||||||95.0|-0.9|1.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||1.5|-0.9|
91518132|NCT01680328|182910569|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.1|-0.4|
91769328|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|1.0||||0.826|TWO_SIDED|95.0|-7.92|9.87||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||9.87|-7.92|0.826
91518133|NCT01680328|182910569|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.6||||||95.0|0.3|2.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.8|0.3|
91518134|NCT01680328|182910569|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.9||||||95.0|3.7|6.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||6.1|3.7|
91518135|NCT01680328|182910569|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.7||||||95.0|0.5|2.9||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.9|0.5|
91518136|NCT00765193|182910586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.01||95.0|2.12|2.62|||Regression, Logistic|||The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSE||2.62|2.12|<0.01
91518137|NCT04370054|182910591|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-3.49|||=|0.004|TWO_SIDED|95.0|-6.06|-0.91||One-sided p-value is reported.|Generalized linear model (GLM)||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-0.91|-6.06|=0.0040
91518138|NCT04370054|182910592|SUPERIORITY||||||=|0.0086||||||One-sided p-value is reported.|One-sided exact binomial proportion test|||||||=0.0086
91518139|NCT04370054|182910593|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-4.01|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.45||One-sided p-value is reported.|Repeated measures GLM||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-2.45|-5.57|<0.0001
91518140|NCT04370054|182910594|SUPERIORITY||Mean Difference (Final Values)|-124.18|||<|0.0001|TWO_SIDED|95.0|-139.47|108.89||One-sided p-value is reported.|Paired t-test||Treatment Difference = (PF-07055480 AIR - FVIII Prophylaxis AIR).|||108.89|-139.47|<0.0001
91518141|NCT04370054|182910596|SUPERIORITY||Mean Difference (Final Values)|-4076.06|||<|0.0001|TWO_SIDED|95.0|-4728.3|-3423.8||One-sided p-value is reported.|Paired t-test||Treatment Difference (FVIII Consumption post-IP Infusion - FVIII Consumption during FVIII Prophylaxis).|||-3423.8|-4728.3|<0.0001
91518142|NCT00710424|182910641|SUPERIORITY_OR_OTHER_LEGACY||estimated treatment effect|-0.12||||0.634|TWO_SIDED|95.0|-0.6|0.36|||ANCOVA||A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.|The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.36|-0.60|0.634
91518143|NCT00710424|182910642|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.37|STANDARD_ERROR_OF_MEAN|2.153||0.865|TWO_SIDED|95.0|-3.87|4.61|||ANCOVA|||The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||4.61|-3.87|0.865
91518144|NCT00710424|182910643|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.45||||0.139|TWO_SIDED|95.0|-1.04|0.15|||ANCOVA|||The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.15|-1.04|0.139
91518145|NCT00710424|182910644|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.301||||0.219|TWO_SIDED|95.0|0.855|1.981|||Regression, Logistic|||In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.||1.981|0.855|0.219
91518146|NCT00710424|182910645|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.05||||0.841|TWO_SIDED|95.0|-0.51|0.42|||ANCOVA|||The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.42|-0.51|0.841
91518147|NCT00710424|182910646|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.523|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.||0.03|-0.06|0.523
91518148|NCT00710424|182910647|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.17||||0.41|TWO_SIDED|95.0|-0.59|0.24|||ANCOVA|||The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.||0.24|-0.59|0.410
91769329|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.4||||0.885|TWO_SIDED|95.0|-4.82|5.58||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.58|-4.82|0.885
91562838|NCT01357564|183013820|SUPERIORITY||Mean Difference (Net)|-0.1||||0.03|TWO_SIDED|95.0|-0.14|-0.01|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.01|-0.14|.03
91562839|NCT02282761|183013829|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.83||0.182|TWO_SIDED|95.0|-6.17|1.05|||Mixed Effects Model for Repeated Measure|||||1.05|-6.17|0.182
91562840|NCT02282761|183013829|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.82||0.045|TWO_SIDED|95.0|-7.75|-0.6|||Mixed Effects Model for Repeated Measure|||||-0.60|-7.75|0.045
91562841|NCT02282761|183013830|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.045|TWO_SIDED|95.0|-0.54|-0.12|||Mixed Effects Model for Repeated Measure|||||-0.12|-0.54|0.045
91562842|NCT06312566|183013831|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 92.016% CI limits for Cmax,ss was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9726|||||TWO_SIDED|92.016|0.9257|1.022|||Linear mixed model analysis|||||1.022|0.9257|
91562843|NCT06312566|183013832|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(tau) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9999|||||TWO_SIDED|92.016|0.9881|1.012||||||||1.012|0.9881|
91562844|NCT04551053|183013836|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.8||||0.2567|TWO_SIDED|95.0|0.65|5.02||CMH test for un-equality stratified by Dynamic International Prognostic Scoring System (DIPSS) category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/Liters \[L\] versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||5.02|0.65|0.2567
91562845|NCT04551053|183013837|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.34||||0.5349|TWO_SIDED|95.0|0.53|3.39||calculated from Cochran Mantel-Haenszel test for un-equality stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/L versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||3.39|0.53|0.5349
91562846|NCT04551053|183013839|SUPERIORITY|||||||0.2224||||||calculated from log-rank test stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 x 10\^9/L versus 50 to \<100 x 10\^9/L inclusive)|Log Rank|||||||0.2224
91562847|NCT00645411|183013897|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.72|1.01|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay||1.01|0.72|
91769330|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.1||||0.964|TWO_SIDED|95.0|-6.03|5.76||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.76|-6.03|0.964
91518149|NCT00710424|182910650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.857||||0.521|TWO_SIDED|95.0|0.537|1.37|||Regression, Logistic|||The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.||1.370|0.537|0.521
91562848|NCT00645411|183013897|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.59|||||TWO_SIDED|95.0|0.49|0.72|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||0.72|0.49|
91562849|NCT00645411|183013897|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.56|||||TWO_SIDED|95.0|0.46|0.68|||ANOVA|||Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.||0.68|0.46|
91562850|NCT00645411|183013897|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.92|||||TWO_SIDED|95.0|0.79|1.08|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||1.08|0.79|
91562851|NCT00645411|183013897|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.65|||||TWO_SIDED|95.0|0.54|0.78|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0.78|0.54|
91769331|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|1.1||||0.806|TWO_SIDED|95.0|-7.59|9.72||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||9.72|-7.59|0.806
91769332|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|0.4||||0.871|TWO_SIDED|95.0|-4.65|5.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.47|-4.65|0.871
91562852|NCT00645411|183013897|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was \>0.667.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.71|1.06|||ANOVA|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||1.06|0.71|
91562853|NCT00645411|183013898|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference in % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-4.0|1.0|||binomial or the method of Miettinen and|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.||1|-4|
91562854|NCT00645411|183013898|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV - eTIV)|-9.0|||||TWO_SIDED|95.0|-13.0|-4.0|||binomial or Miettinen & Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||-4|-13|
91562855|NCT00645411|183013898|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-15.0|||||TWO_SIDED|95.0|-21.0|-9.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.||-9|-21|
91769333|NCT02365649|183425736|SUPERIORITY||LS Mean of Difference|-0.5||||0.85|TWO_SIDED|95.0|-6.28|5.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.19|-6.28|0.850
91562856|NCT00645411|183013898|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%|Difference % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||2|-3|
91562857|NCT00645411|183013898|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-5.0|||||TWO_SIDED|95.0|-9.5|0.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0|-9.5|
91562858|NCT00645411|183013898|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|0.0|||||TWO_SIDED|95.0|-6.0|6.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||6|-6|
91562859|NCT01867307|183013955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-220.0|STANDARD_ERROR_OF_MEAN|55.5|<|0.0001|TWO_SIDED|95.0|-440.6|-202.7||P-value is from a paired t-test.|Paired t- test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-202.7|-440.6|<0.0001
91562860|NCT01867307|183013955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-234.0|STANDARD_ERROR_OF_MEAN|25.8|<|0.0001|TWO_SIDED|95.0|-312.3|-201.5||P-value is from a paired t-test|Paired t-test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-201.5|-312.3|<0.0001
91562861|NCT00091572|183013962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2663||95.0|0.8|1.06|||Log Rank||Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.|||1.06|0.80|0.2663
91562862|NCT00091572|183013963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9999||95.0|0.86|1.17|||Log Rank||Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.|||1.17|0.86|0.9999
91562863|NCT00091572|183013964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.0718||95.0|0.97|2.12|||Cochran-Mantel-Haenszel||Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.|||2.12|0.97|0.0718
91562864|NCT00267774|183013967|OTHER||||||<|0.0001||||||A 2-sided value of P\<0.05 was considered to indicate statistical significance.|t-test, 2 sided|||||||<0.0001
91769334|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|-3.9||||0.792|TWO_SIDED|95.0|-33.73|25.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||25.90|-33.73|0.792
91562865|NCT01044901|183013989|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
91769335|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|18.1||||0.179|TWO_SIDED|95.0|-8.62|44.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||44.75|-8.62|0.179
91562866|NCT01044901|183013990|OTHER||||||<|0.0001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney test).||||<0.0001
91562867|NCT01044901|183013991|OTHER|||||||0.0137|||||||t-test, 2 sided|P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0137
91562868|NCT01044901|183013992|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
91562869|NCT01044901|183013993|OTHER|||||||0.16||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.16
91562870|NCT01044901|183013994|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
91562871|NCT01044901|183013995|OTHER|||||||0.0011||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0011
91562872|NCT01044901|183013996|OTHER|||||||0.1||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.10
91562873|NCT01044901|183013997|OTHER|||||||0.48||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.48
91769336|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|-19.1||||0.23|TWO_SIDED|95.0|-50.87|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||12.63|-50.87|0.230
91562874|NCT01044901|183013998|OTHER|||||||0.08||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.08
91562875|NCT01044901|183013999|OTHER|||||||0.91||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.91
91562876|NCT01044901|183014000|OTHER|||||||0.0038||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0038
91562877|NCT01044901|183014001|OTHER|||||||0.034||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.034
91562878|NCT01044901|183014002|OTHER|||||||0.25||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented was as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.25
91562879|NCT01044901|183014003|OTHER|||||||0.0288||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0288
91562880|NCT01044901|183014004|OTHER|||||||0.14||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.14
91562881|NCT01044901|183014005|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.13
91562882|NCT01044901|183014006|OTHER|||||||0.81||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.81
91769337|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|16.4||||0.337|TWO_SIDED|95.0|-17.54|50.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||50.40|-17.54|0.337
91769338|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|1.1||||0.924|TWO_SIDED|95.0|-21.75|23.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.93|-21.75|0.924
91562883|NCT01044901|183014007|OTHER|||||||0.3||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.30
91562884|NCT03322514|183014009|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
91562885|NCT03322514|183014009|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.04
91562886|NCT03322514|183014009|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.1
91562887|NCT03322514|183014010|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
91562888|NCT03322514|183014010|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
91562889|NCT03322514|183014010|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
91562890|NCT03322514|183014011|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
91562891|NCT03322514|183014011|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.4
91562892|NCT03322514|183014011|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||baseline to 12 weeks||||0.7
91562893|NCT00088452|183014012|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Chi-squared||odds ratio with ethosuximide vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||4.28|1.65|<0.001
91769339|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|-11.7||||0.373|TWO_SIDED|95.0|-37.69|14.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||14.35|-37.69|0.373
91562894|NCT00088452|183014012|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.06|5.42|||Chi-squared||odds ratio with valproic acid vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||5.42|2.06|<0.001
91562895|NCT00088452|183014013|SUPERIORITY||Odds Ratio (OR)|1.95||||0.03|TWO_SIDED|95.0|1.12|3.41|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the ethosuximide group|||3.41|1.12|0.03
91562896|NCT00088452|183014013|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.001|TWO_SIDED|95.0|1.69|5.49|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the lamotrigine group|||5.49|1.69|<0.001
91562897|NCT00088452|183014014|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.81|5.33|||Fisher Exact||Odds ratio for FFF for ethosuximide versus lamotrigine|||5.33|1.81|<0.001
91562898|NCT00088452|183014014|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.68|5.02|||Fisher Exact||odds ratio for FFF for valproic acid versus lamotrigine|||5.02|1.68|<0.001
91562899|NCT02081196|183014021|OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|3.08|4.77|||||Treatment Effect =Control Flank Change-Treated Flank Change such (a positive results indicates treated area had a larger reduction in fat thickness than control area, and a negative result indicates that a greater reduction was seen in control area).|H0: μ(Control - Treated) \< +1 versus H1: μ(Control - Treated) \> +1||4.77|3.08|
91562900|NCT02081196|183014022|OTHER||sucess proportion|0.8476|||||TWO_SIDED|95.0|0.784|0.913|||||||Descriptive statistics (tabulation of Independent Panel Reviewer ratings) were used to analyze data.|.913|.784|
91562901|NCT00097708|183014024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.654|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6540
91562902|NCT00097708|183014024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.0005|TWO_SIDED|95.0|-5.0|-1.4|||ANCOVA|||||-1.4|-5.0|0.0005
91562903|NCT00097708|183014024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5|||ANCOVA|||||4.5|1.1|0.0015
91562904|NCT06091982|183014040|SUPERIORITY||Odds Ratio (OR)|10.6|||<|0.0001|TWO_SIDED|95.0|7.0|16.2|||Chi-squared|||Bivariable analysis of both groups||16.2|7.0|<0.0001
91562905|NCT06091982|183014040|OTHER|Multiple logistic regression|Odds Ratio, log|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|6.1|||Regression, Logistic|||Multivariable analysis||6.1|2.0|<0.0001
91562906|NCT06091982|183014041|SUPERIORITY||Odds Ratio (OR)|12.5|||<|0.0001|TWO_SIDED|95.0|9.1|17.1|||Chi-squared|||||17.1|9.1|<0.0001
91562907|NCT06091982|183014041|SUPERIORITY||Odds Ratio, log|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|7.0|||Regression, Logistic|||||7.0|2.8|<0.0001
91562908|NCT06091982|183014042|SUPERIORITY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|95.0|11.3|21.6|||Chi-squared|||||21.6|11.3|<0.0001
91562909|NCT06091982|183014042|OTHER||Odds Ratio, log|5.2|||<|0.0001|TWO_SIDED|95.0|3.3|8.2|||Regression, Logistic|||||8.2|3.3|<0.0001
91562910|NCT04198428|183014059|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
91562911|NCT04198428|183014060|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
91562912|NCT04198428|183014061|SUPERIORITY||Odds Ratio (OR)|1.43|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
91562913|NCT04198428|183014062|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Zero-inflated negative binomial mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
91769340|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|-3.1||||0.813|TWO_SIDED|95.0|-28.94|22.79||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||22.79|-28.94|0.813
91562914|NCT04198428|183014063|SUPERIORITY||Risk Ratio (RR)|0.93|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
91562915|NCT04198428|183014064|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
91562916|NCT04198428|183014065|SUPERIORITY||Mean Difference (Net)|-1068.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index costs in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
91562917|NCT04198428|183014066|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
91562918|NCT04198428|183014067|SUPERIORITY||Risk Ratio (RR)|1.08|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
91562919|NCT00627523|183014073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|0.82|1.59||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference in the mean change from Baseline after 24 months in height SDS between the Genotropin® and the untreated control groups. The alternative hypothesis was that there was a difference between the treatment groups.||1.59|0.82|<0.001
91562920|NCT00627523|183014074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-0.87|2.42||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||2.42|-0.87|0.348
91562921|NCT00627523|183014075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|0.55|1.23||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||1.23|0.55|<0.001
91562922|NCT00627523|183014076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|1.63|4.85||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.85|1.63|<0.001
91562923|NCT00627523|183014077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|7.19||0.738|TWO_SIDED|95.0|-12.27|17.12||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||17.12|-12.27|0.738
91562924|NCT00627523|183014078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|4.27||0.301|TWO_SIDED|95.0|-13.27|4.26||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.26|-13.27|0.301
91562925|NCT05030467|183014083|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.39|0.31||||||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.31|-0.39|
91562926|NCT05030467|183014084|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|1.0|1.03|||Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and Poisson-distributed errors, adjusting for clinic-level clustering.||1.03|1.00|0.011
91562927|NCT05030467|183014087|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.383|TWO_SIDED|95.0|-0.38|0.15|||Regression, Linear|||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.15|-0.38|0.383
91562928|NCT05129592|183014113|SUPERIORITY||Mean Difference (Final Values)|15.71|STANDARD_ERROR_OF_MEAN|7.3||0.095|TWO_SIDED|95.0|-1.87|33.3||Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective control and Nicotine corrective with both components of coherence|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|||33.30|-1.87|0.095
91769341|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|5.3||||0.651|TWO_SIDED|95.0|-18.02|28.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||28.65|-18.02|0.651
91769342|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|-23.8||||0.065|TWO_SIDED|95.0|-49.12|1.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||1.49|-49.12|0.065
91769343|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|5.3||||0.802|TWO_SIDED|95.0|-37.61|48.28||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||48.28|-37.61|0.802
91562929|NCT05129592|183014113|SUPERIORITY||Mean Difference (Final Values)|18.67|STANDARD_ERROR_OF_MEAN|7.3||0.022|TWO_SIDED|95.0|2.02|35.33||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with causal explanation and Nicotine corrective with both components of coherence||35.33|2.02|0.022
91562930|NCT05129592|183014113|SUPERIORITY||Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|7.3||0.931|TWO_SIDED|95.0|-12.76|20.15||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective with reason for misperception to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with reason for misperception and Nicotine corrective with both components of coherence||20.15|-12.76|0.931
91562931|NCT05129592|183014114|SUPERIORITY||Odds Ratio (OR)|1.54||||0.402|TWO_SIDED|95.0|0.56|4.24|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||4.24|0.56|0.402
91562932|NCT05129592|183014114|SUPERIORITY||Odds Ratio (OR)|1.83||||0.292|TWO_SIDED|95.0|0.59|5.62|||Regression, Logistic||Odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the control condition/odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||5.62|0.59|0.292
91562933|NCT05129592|183014114|SUPERIORITY||Odds Ratio (OR)|0.77||||0.571|TWO_SIDED|95.0|0.3|1.93|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||1.93|0.30|0.571
91562934|NCT05129592|183014114|SUPERIORITY||Odds Ratio (OR)|1.98|STANDARD_ERROR_OF_MEAN|1.44||0.349|TWO_SIDED|95.0|0.47|8.26|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the control condition/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||8.26|0.47|0.349
91562935|NCT05129592|183014114|SUPERIORITY||Odds Ratio (OR)|1.76|STANDARD_ERROR_OF_MEAN|1.07||0.355|TWO_SIDED|95.0|0.53|5.81|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||5.81|0.53|0.355
91562936|NCT05129592|183014114|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.42||0.591|TWO_SIDED|95.0|0.24|2.25|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||2.25|0.24|0.591
91562937|NCT05129592|183014115|SUPERIORITY|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.99||0.98|TWO_SIDED|95.0|0.13|7.27|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|||7.27|0.13|0.980
91562938|NCT05129592|183014115|SUPERIORITY||Odds Ratio (OR)|0.47|STANDARD_ERROR_OF_MEAN|0.41||0.382|TWO_SIDED|95.0|0.09|2.56|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||2.56|0.09|0.382
91562939|NCT05129592|183014115|SUPERIORITY||Odds Ratio, log|0.83|STANDARD_ERROR_OF_MEAN|0.79||0.846|TWO_SIDED|95.0|0.13|5.23|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||5.23|0.13|0.846
91562940|NCT05129592|183014115|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.05||0.99|TWO_SIDED|95.0|0.13|7.74|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||7.74|0.13|0.990
91562941|NCT05129592|183014115|SUPERIORITY||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.46||0.458|TWO_SIDED|95.0|0.09|3.01|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||3.01|0.09|0.458
91562942|NCT05129592|183014115|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.7||0.754|TWO_SIDED|95.0|0.12|4.76|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||4.76|0.12|0.754
91562943|NCT05129592|183014116|SUPERIORITY||Odds Ratio, log|1.69|STANDARD_ERROR_OF_MEAN|0.78||0.256|TWO_SIDED|95.0|0.68|4.15|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||4.15|0.68|0.256
91562944|NCT05129592|183014116|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.43||0.961|TWO_SIDED|95.0|0.45|2.32|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||2.32|0.45|0.961
91562945|NCT05129592|183014116|SUPERIORITY||Odds Ratio (OR)|0.67|STANDARD_ERROR_OF_MEAN|0.28||0.345|TWO_SIDED|95.0|0.3|1.53|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||1.53|0.30|0.345
91562946|NCT05129592|183014116|SUPERIORITY||Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|0.76||0.36|TWO_SIDED|95.0|0.6|4.04|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||4.04|0.60|0.360
91562947|NCT05129592|183014116|SUPERIORITY||Odds Ratio (OR)|1.14|STANDARD_ERROR_OF_MEAN|0.5||0.765|TWO_SIDED|95.0|0.48|2.7|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||2.70|0.48|0.765
91562948|NCT05129592|183014116|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.25|1.43|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||1.43|0.25|0.252
91562949|NCT05129592|183014117|SUPERIORITY||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|0.18|1.09|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||1.09|0.18|0.077
91562950|NCT05129592|183014117|SUPERIORITY||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.4||0.853|TWO_SIDED|95.0|0.4|2.15|||Regression, Logistic|||Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs|Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|2.15|0.40|0.853
91562951|NCT05129592|183014117|SUPERIORITY||Odds Ratio, log|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|0.18|0.95|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with both components of coherence/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||0.95|0.18|0.037
91562952|NCT05129592|183014117|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.33||0.349|TWO_SIDED|95.0|0.21|1.75|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.75|0.21|0.349
91562953|NCT05129592|183014117|SUPERIORITY||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.74||0.464|TWO_SIDED|95.0|0.54|3.93|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||3.93|0.54|0.464
91562954|NCT05129592|183014117|SUPERIORITY||Odds Ratio (OR)|0.5|STANDARD_ERROR_OF_MEAN|0.26||0.187|TWO_SIDED|95.0|0.18|1.4|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.40|0.18|0.187
91562955|NCT05129592|183014118|SUPERIORITY||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.66||0.925|TWO_SIDED|95.0|0.31|3.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||3.62|0.31|0.925
91562956|NCT05129592|183014118|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.43||0.525|TWO_SIDED|95.0|0.19|2.35|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.35|0.19|0.525
91562957|NCT05129592|183014118|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.44||0.586|TWO_SIDED|95.0|0.21|2.4|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.40|0.21|0.586
91562958|NCT05129592|183014118|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.71||0.883|TWO_SIDED|95.0|0.31|3.9|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||3.90|0.31|0.883
91562959|NCT05129592|183014118|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.44||0.534|TWO_SIDED|95.0|0.18|2.41|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.41|0.18|0.534
91562960|NCT05129592|183014118|SUPERIORITY||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.48||0.661|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.62|0.22|0.661
91562961|NCT05129592|183014119|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|4.66||0.965|TWO_SIDED|95.0|-9.25|13.19|||ANCOVA|Sidak's adjusted p-value (df=4)|Nicotine corrective control - Nicotine corrective with both components of coherence|ANCOVA adjusted for baseline consideration of switching||13.19|-9.25|0.965
91562962|NCT05129592|183014119|SUPERIORITY||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|4.44||0.979|TWO_SIDED|95.0|-9.13|12.27|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with causal explanation - Nicotine corrective with both components of coherence|12.27|-9.13|0.979
91562963|NCT05129592|183014119|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|4.37||0.73|TWO_SIDED|95.0|-6.46|14.59|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with reason for misperception - Nicotine corrective with both components of coherence|14.59|-6.46|0.73
91562964|NCT00331799|183014136|SUPERIORITY_OR_OTHER|||||||0.00365|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.||||0.00365
91562965|NCT02889809|183014137|OTHER||Least Square (LS) Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.462|0.142|||||Analysis was performed using an analysis of covariance (ANCOVA) model adjusting for Baseline growth velocity, age at Visit 1, gender and country.|||0.142|-0.462|
91562966|NCT02889809|183014140|OTHER||LS Mean Difference|0.059|||||TWO_SIDED|95.0|-0.455|0.572|||||Analysis was performed using an ANCOVA model adjusting for Baseline growth velocity, age at Visit 1(wk -16), gender and country|||0.572|-0.455|
91562967|NCT04694300|183014144|SUPERIORITY|Lower the maximum pain intensity score the more effective the analgesic|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91562968|NCT04694300|183014145|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91562969|NCT04694300|183014146|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
91562970|NCT04694300|183014147|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91562971|NCT04694300|183014150|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
91562972|NCT04694300|183014151|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91562973|NCT04694300|183014152|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|Higher percentage inhibition relates to greater selectivity for COX-2||||||0.59
91562974|NCT04694300|183014153|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
91562975|NCT00113880|183014163|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.||||0.01
91562976|NCT00113880|183014163|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.01
91562977|NCT00113880|183014163|SUPERIORITY_OR_OTHER|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
91562978|NCT00113880|183014163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|0.64|3.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||3.92|0.64|0.02
91562979|NCT00113880|183014163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.35||||0.01|TWO_SIDED|95.0|2.2|24.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.54|2.20|0.01
91562980|NCT00113880|183014163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.17||||0.01|TWO_SIDED|95.0|2.13|24.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.13|2.13|0.01
91562981|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.03|TWO_SIDED|95.0|0.0|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.79|0.00|0.03
91562982|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13||||0.05|TWO_SIDED|95.0|0.02|1.0||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||1.00|0.02|0.05
91562983|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11||||0.04|TWO_SIDED|95.0|0.01|0.86||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.86|0.01|0.04
91562984|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.2|0.7||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.70|0.20|0.01
91562985|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.01|TWO_SIDED|95.0|0.22|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the all ages combined group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.74|0.22|0.01
91562986|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.01|TWO_SIDED|95.0|0.03|0.08||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age and the all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.08|0.03|0.01
91562987|NCT00113880|183014164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02||||0.01|TWO_SIDED|95.0|0.01|0.03|||Regression, Cox||Population was the 18-49 year age and all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.03|0.01|0.01
91562988|NCT00113880|183014165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.04|TWO_SIDED|95.0|1.02|4.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Urticaria event rates were presented per 1,000 person-months.||4.13|1.02|0.04
91562989|NCT00113880|183014167|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.89||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.89|0.56|0.01
91562990|NCT00113880|183014167|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.59||||0.01|TWO_SIDED|95.0|0.41|0.83||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.83|0.41|0.01
91562991|NCT00113880|183014167|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.04|TWO_SIDED|95.0|0.46|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.46|0.04
91562992|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.33||||0.01|TWO_SIDED|95.0|0.27|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.41|0.27|0.01
91562993|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.01|TWO_SIDED|95.0|0.22|0.42||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.42|0.22|0.01
91562994|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34||||0.01|TWO_SIDED|95.0|0.24|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.47|0.24|0.01
91769344|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|0.6||||0.955|TWO_SIDED|95.0|-20.46|21.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.63|-20.46|0.955
91769345|NCT02365649|183425737|SUPERIORITY||LS Mean of Difference|-10.6||||0.395|TWO_SIDED|95.0|-35.73|14.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||14.47|-35.73|0.395
91562995|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.23|0.75||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.75|0.23|0.01
91562996|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.01|TWO_SIDED|95.0|0.33|0.44||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.44|0.33|0.01
91562997|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.01|TWO_SIDED|95.0|0.32|0.5||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.50|0.32|0.01
91562998|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36||||0.01|TWO_SIDED|95.0|0.28|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.45|0.28|0.01
91562999|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41||||0.01|TWO_SIDED|95.0|0.27|0.6||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.60|0.27|0.01
91769346|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|-0.0082||||0.893|TWO_SIDED|95.0|-0.1299|0.1136||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1136|-0.1299|0.893
91769347|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0685||||0.182|TWO_SIDED|95.0|-0.0334|0.1705||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1705|-0.0334|0.182
91769348|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|-0.1323||||0.036|TWO_SIDED|95.0|-0.2552|-0.0093||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||-0.0093|-0.2552|0.036
91769349|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0768||||0.316|TWO_SIDED|95.0|-0.0749|0.2286||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.2286|-0.0749|0.316
91769350|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0573||||0.277|TWO_SIDED|95.0|-0.0471|0.1617||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1617|-0.0471|0.277
91769351|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0428||||0.467|TWO_SIDED|95.0|-0.0741|0.1597||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1597|-0.0741|0.467
91563000|NCT00113880|183014168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.05|TWO_SIDED|95.0|0.21|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years, PD2 within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.21|0.05
91563001|NCT00113880|183014169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.01|TWO_SIDED|95.0|0.86|0.98||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.98|0.86|0.01
91563002|NCT00113880|183014169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.01|TWO_SIDED|95.0|0.75|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs., within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.92|0.75|0.01
91563003|NCT00113880|183014169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.01|TWO_SIDED|95.0|0.81|0.94||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: All ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.94|0.81|0.01
91563004|NCT00113880|183014169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.01|TWO_SIDED|95.0|0.7|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.88|0.70|0.01
91563005|NCT00113880|183014169|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.29|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.79|0.29|0.01
91563006|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.01|TWO_SIDED|95.0|0.45|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.51|0.45|0.01
91563007|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.47|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.56|0.47|0.01
91769352|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|-0.036||||0.464|TWO_SIDED|95.0|-0.1336|0.0616||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.0616|-0.1336|0.464
91769353|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0404||||0.345|TWO_SIDED|95.0|-0.0444|0.1252||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.1252|-0.0444|0.345
91563008|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.46||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.46|0.38|0.01
91563009|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.01|TWO_SIDED|95.0|0.49|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.49|0.01
91563010|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.33|0.76||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.76|0.33|0.01
91563011|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.39|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates event rates were presented per 1,000 person-months.||0.45|0.39|0.01
91563012|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.47|0.38|0.01
91563013|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.01|TWO_SIDED|95.0|0.34|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.41|0.34|0.01
91563014|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.58||||0.05|TWO_SIDED|95.0|0.49|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.68|0.49|0.05
91563015|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28||||0.01|TWO_SIDED|95.0|0.15|0.52||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/Rad event rates were presented per 1,000 person-months.||0.52|0.15|0.01
91563016|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.66|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.85|0.66|0.01
91563017|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.02|TWO_SIDED|95.0|0.7|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.97|0.70|0.02
91769354|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|-0.0873||||0.071|TWO_SIDED|95.0|-0.1822|0.0076||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||0.0076|-0.1822|0.071
91769355|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.1109||||0.317|TWO_SIDED|95.0|-0.1109|0.3326||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.3326|-0.1109|0.317
91563018|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.88|0.58|0.01
91769356|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0848||||0.125|TWO_SIDED|95.0|-0.0248|0.1945||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1945|-0.0248|0.125
91769357|NCT02365649|183425738|SUPERIORITY||LS Mean of Difference|0.0559||||0.39|TWO_SIDED|95.0|-0.0745|0.1864||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1864|-0.0745|0.390
91563019|NCT00113880|183014170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.27|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.78|0.27|0.01
91563020|NCT00113880|183014171|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.04|TWO_SIDED|95.0|0.0|0.82||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Encephalitis/encephalopathy event rates were presented per 1,000 person-months.||0.82|0.00|0.04
91563021|NCT00113880|183014172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
91563022|NCT00113880|183014172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
91563023|NCT00113880|183014172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
91563024|NCT00113880|183014172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
91563025|NCT00113880|183014173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
91563026|NCT00113880|183014173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
91563027|NCT00113880|183014173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
91563028|NCT00113880|183014173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
91563029|NCT00113880|183014174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.57|0.73||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.73|0.57|0.01
91563030|NCT00113880|183014174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.36|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.51|0.36|0.01
91563031|NCT00113880|183014175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.01|TWO_SIDED|95.0|0.26|0.33||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.33|0.26|0.01
91563032|NCT00113880|183014175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.01|TWO_SIDED|95.0|0.13|0.18||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.18|0.13|0.01
91563033|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.04|TWO_SIDED|95.0|0.03|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||0.93|0.03|0.04
91563034|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.4|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.92|0.40|0.02
91563035|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.28|0.84||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.84|0.28|0.01
91563036|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.1|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.78|0.10|0.02
91563037|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.02|TWO_SIDED|95.0|0.63|0.96||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.96|0.63|0.02
91563038|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69||||0.03|TWO_SIDED|95.0|0.5|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.97|0.50|0.03
91563039|NCT00113880|183014176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01||95.0|0.21|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.79|0.21|0.01
91563040|NCT00113880|183014177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.95||||0.02|TWO_SIDED|95.0|1.14|3.34||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||3.34|1.14|0.02
91563041|NCT00113880|183014177|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
91563042|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.15|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.57|0.15|0.01
91563043|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.03|TWO_SIDED|95.0|0.12|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.92|0.12|0.03
91769358|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|8.7||||0.263|TWO_SIDED|95.0|-6.79|24.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||24.16|-6.79|0.263
91563044|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.13|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.74|0.13|0.01
91563045|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.04|TWO_SIDED|95.0|0.55|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.99|0.55|0.04
91563046|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.04|TWO_SIDED|95.0|0.14|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.93|0.14|0.04
91563047|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.02|TWO_SIDED|95.0|0.71|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.97|0.71|0.02
91563048|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.01|TWO_SIDED|95.0|0.57|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.92|0.57|0.01
91563049|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.01|TWO_SIDED|95.0|0.22|0.61||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.61|0.22|0.01
91563050|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.16|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.68|0.16|0.01
91563051|NCT00113880|183014178|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.03|TWO_SIDED|95.0|0.0|0.82|||Fisher Exact||Population: 18-49, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.82|0.00|0.03
91563052|NCT00113880|183014179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.58|0.01
91563053|NCT00113880|183014179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.49|0.01
91563054|NCT00113880|183014179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.01|TWO_SIDED|95.0|0.61|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.92|0.61|0.01
91563055|NCT00113880|183014179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.91|0.52|0.01
91563056|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01|TWO_SIDED|95.0|0.33|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.51|0.33|0.01
91563057|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.26|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.55|0.26|0.01
91563058|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.01|TWO_SIDED|95.0|0.31|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.56|0.31|0.01
91563059|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.26|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.26|0.02
91563060|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01||95.0|0.37|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.55|0.37|0.01
91563061|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.01|TWO_SIDED|95.0|0.35|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.35|0.01
91563062|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.33|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.56|0.33|0.01
91563063|NCT00113880|183014180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||0.01|TWO_SIDED|95.0|0.25|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.85|0.25|0.01
91563064|NCT00113880|183014181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.01|TWO_SIDED|95.0|0.32|0.69||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.69|0.32|0.01
91563065|NCT00113880|183014181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.17|0.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.54|0.17|0.01
91563066|NCT02592434|183014189|SUPERIORITY||Difference in percentage|-23.69||||0.0031|TWO_SIDED|95.0|-39.41|-7.97||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||-7.97|-39.41|0.0031
91563067|NCT02592434|183014190|SUPERIORITY||Difference in percentage|19.52||||0.0166|TWO_SIDED|95.0|3.55|35.5||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||35.50|3.55|0.0166
91563068|NCT02592434|183014191|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||39.41|7.97|0.0031
91563069|NCT02592434|183014192|SUPERIORITY||Difference in percentage|17.02||||0.0387|TWO_SIDED|95.0|0.88|33.17||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||33.17|0.88|0.0387
91769359|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|15.2||||0.031|TWO_SIDED|95.0|1.47|28.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||28.93|1.47|0.031
91769360|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|-12.0||||0.135|TWO_SIDED|95.0|-27.93|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||3.90|-27.93|0.135
91769361|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|6.3||||0.458|TWO_SIDED|95.0|-10.61|23.27||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.27|-10.61|0.458
91563070|NCT02592434|183014193|SUPERIORITY||Ls mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01||Threshold for significance at 0.05 level.|Mixed Model for Repeated Measures (MMRM)|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.01|-0.22|0.0292
91563071|NCT02592434|183014195|SUPERIORITY||Difference in percentage|-1.71||||0.741|TWO_SIDED|95.0|-11.82|8.41|||Normal approximation to the binomial|||at Week 20||8.41|-11.82|0.7410
91563072|NCT02592434|183014195|SUPERIORITY||Difference in percentage|-18.93||||0.0052|TWO_SIDED|95.0|-32.22|-5.64|||Normal approximation to the binomial|||at Week 24||-5.64|-32.22|0.0052
91563073|NCT02592434|183014195|SUPERIORITY||Difference in percentage|-19.09||||0.0093|TWO_SIDED|95.0|-33.48|-4.7|||Normal approximation to the binomial|||at Week 28||-4.70|-33.48|0.0093
91563074|NCT02592434|183014195|SUPERIORITY||Difference in percentage|-22.1||||0.0045|TWO_SIDED|95.0|-37.35|-6.86|||Normal approximation to the binomial|||at Week 32||-6.86|-37.35|0.0045
91563075|NCT02592434|183014195|SUPERIORITY||Difference in percentage|-23.57||||0.0027|TWO_SIDED|95.0|-38.97|-8.17|||Normal approximation to the binomial|||at Week 36||-8.17|-38.97|0.0027
91563076|NCT02592434|183014195|SUPERIORITY||Difference in percentage|-25.08||||0.0016|TWO_SIDED|95.0|-40.69|-9.47|||Normal approximation to the binomial|||at Week 40||-9.47|-40.69|0.0016
91563077|NCT02592434|183014199|SUPERIORITY||Difference in percentage|6.03||||0.301|TWO_SIDED|95.0|-5.4|17.46|||Normal approximation to the binomial|||at Week 20||17.46|-5.40|0.3010
91563078|NCT02592434|183014199|SUPERIORITY||Difference in percentage|17.54||||0.0108|TWO_SIDED|95.0|4.05|31.03|||Normal approximation to the binomial|||at Week 24||31.03|4.05|0.0108
91563079|NCT02592434|183014199|SUPERIORITY||Difference in percentage|19.13||||0.0103|TWO_SIDED|95.0|4.51|33.74|||Normal approximation to the binomial|||at Week 28||33.74|4.51|0.0103
91563080|NCT02592434|183014199|SUPERIORITY||Difference in percentage|23.53||||0.0025|TWO_SIDED|95.0|8.27|38.8|||Normal approximation to the binomial|||at Week 32||38.80|8.27|0.0025
91563081|NCT02592434|183014199|SUPERIORITY||Difference in percentage|25.04||||0.0016|TWO_SIDED|95.0|9.52|40.56|||Normal approximation to the binomial|||at Week 36||40.56|9.52|0.0016
91563082|NCT02592434|183014199|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41|||Normal approximation to the binomial|||at Week 40||39.41|7.97|0.0031
91563083|NCT02592434|183014201|SUPERIORITY||Difference in percentage|-1.15||||0.8119|TWO_SIDED|95.0|-10.63|8.33|||Normal approximation for binomial|||Double Blind Baseline (Week 18)||8.33|-10.63|0.8119
91563084|NCT02592434|183014201|SUPERIORITY||Difference in percentage|7.66||||0.2682|TWO_SIDED|95.0|-5.9|21.21|||Normal approximation for binomial|||Week 20||21.21|-5.90|0.2682
91563085|NCT02592434|183014201|SUPERIORITY||Difference in percentage|21.98||||0.0034|TWO_SIDED|95.0|7.26|36.71|||Normal approximation for binomial|||Week 24||36.71|7.26|0.0034
91563086|NCT02592434|183014201|SUPERIORITY||Difference in percentage|17.9||||0.0233|TWO_SIDED|95.0|2.44|33.36|||Normal approximation for binomial|||Week 28||33.36|2.44|0.0233
91563087|NCT02592434|183014201|SUPERIORITY||Difference in percentage|25.16||||0.0018|TWO_SIDED|95.0|9.39|40.93|||Normal approximation for binomial|||Week 32||40.93|9.39|0.0018
91563088|NCT02592434|183014201|SUPERIORITY||Difference in percentage|20.91||||0.0099|TWO_SIDED|95.0|5.01|36.81|||Normal approximation for binomial|||Week 36||36.81|5.01|0.0099
91563089|NCT02592434|183014201|SUPERIORITY||Difference in percentage|22.34||||0.0058|TWO_SIDED|95.0|6.46|38.22|||Normal approximation for binomial|||Week 40||38.22|6.46|0.0058
91563090|NCT02592434|183014203|SUPERIORITY||Difference in percentage|3.77||||0.6348|TWO_SIDED|95.0|-11.79|19.33|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||19.33|-11.79|0.6348
91563091|NCT02592434|183014203|SUPERIORITY||Difference in percentage|2.62||||0.7525|TWO_SIDED|95.0|-13.66|18.9|||Normal approximation to the binomial|||Week 20||18.90|-13.66|0.7525
91563092|NCT02592434|183014203|SUPERIORITY||Difference in percentage|14.05||||0.0908|TWO_SIDED|95.0|-2.23|30.33|||Normal approximation to the binomial|||Week 24||30.33|-2.23|0.0908
91563093|NCT02592434|183014203|SUPERIORITY||Difference in percentage|7.02||||0.4026|TWO_SIDED|95.0|-9.38|23.43|||Normal approximation to the binomial|||Week 28||23.43|-9.38|0.4026
91563094|NCT02592434|183014203|SUPERIORITY||Difference in percentage|18.37||||0.0258|TWO_SIDED|95.0|2.22|34.52|||Normal approximation to the binomial|||Week 32||34.52|2.22|0.0258
91563095|NCT02592434|183014203|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 36||35.88|3.88|0.0149
91563096|NCT02592434|183014203|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 40||35.88|3.88|0.0149
91563097|NCT02592434|183014205|SUPERIORITY||Difference in percentage|-5.24||||0.515|TWO_SIDED|95.0|-21.0|10.53|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||10.53|-21.00|0.5150
91563098|NCT02592434|183014205|SUPERIORITY||Difference in percentage|9.01||||0.24||95.0|-6.02|24.03|||Normal approximation to the binomial|||Week 20||24.03|-6.02|0.2400
91563099|NCT02592434|183014205|SUPERIORITY||Difference in percentage|8.93||||0.2557|TWO_SIDED|95.0|-6.47|24.33|||Normal approximation to the binomial|||Week 24||24.33|-6.47|0.2557
91563100|NCT02592434|183014205|SUPERIORITY||Difference in percentage|8.97||||0.2481|TWO_SIDED|95.0|-6.25|24.19|||Normal approximation to the binomial|||Week 28||24.19|-6.25|0.2481
91563101|NCT02592434|183014205|SUPERIORITY||Difference in percentage|16.03||||0.0356|TWO_SIDED|95.0|1.08|30.98|||Normal approximation to the binomial|||Week 32||30.98|1.08|0.0356
91563102|NCT02592434|183014205|SUPERIORITY||Difference in percentage|18.89||||0.0115|TWO_SIDED|95.0|4.24|33.54|||Normal approximation to the binomial|||Week 36||33.54|4.24|0.0115
91563103|NCT02592434|183014205|SUPERIORITY||Difference in percentage|11.87||||0.115|TWO_SIDED|95.0|-2.89|26.62|||Normal approximation to the binomial|||Week 40||26.62|-2.89|0.1150
91563104|NCT02592434|183014205|SUPERIORITY||Difference in percentage|13.29||||0.0744|TWO_SIDED|95.0|-1.31|27.9|||Normal approximation to the binomial|||Week 44||27.90|-1.31|0.0744
91563105|NCT02592434|183014207|SUPERIORITY||Difference in percentage|-16.15||||0.0207|TWO_SIDED|95.0|-29.84|-2.46|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||-2.46|-29.84|0.0207
91563106|NCT02592434|183014207|SUPERIORITY||Difference in percentage|10.63||||0.1254|TWO_SIDED|95.0|-2.97|24.24|||Normal approximation to the binomial|||Week 20||24.24|-2.97|0.1254
91563107|NCT02592434|183014207|SUPERIORITY||Difference in percentage|3.49||||0.635|TWO_SIDED|95.0|-10.93|17.91|||Normal approximation to the binomial|||Week 24||17.91|-10.93|0.6350
91563108|NCT02592434|183014207|SUPERIORITY||Difference in percentage|2.1||||0.7732|TWO_SIDED|95.0|-12.2|16.41|||Normal approximation to the binomial|||Week 28||16.41|-12.20|0.7732
91563109|NCT02592434|183014207|SUPERIORITY||Difference in percentage|6.35||||0.3782|TWO_SIDED|95.0|-7.77|20.47|||Normal approximation to the binomial|||Week 32||20.47|-7.77|0.3782
91563110|NCT02592434|183014207|SUPERIORITY||Difference in percentage|11.98||||0.0936|TWO_SIDED|95.0|-2.02|25.99|||Normal approximation to the binomial|||Week 36||25.99|-2.02|0.0936
91563111|NCT02592434|183014207|SUPERIORITY||Difference in percentage|9.17||||0.2017|TWO_SIDED|95.0|-4.91|23.24|||Normal approximation to the binomial|||Week 40||23.24|-4.91|0.2017
91563112|NCT02592434|183014207|SUPERIORITY||Difference in percentage|12.02||||0.0858|TWO_SIDED|95.0|-1.69|25.74|||Normal approximation to the binomial|||Week 44||25.74|-1.69|0.0858
91563113|NCT02592434|183014209|SUPERIORITY||LS mean difference|-2.07|STANDARD_ERROR_OF_MEAN|0.78||0.0088|TWO_SIDED|95.0|-3.6|-0.53|||MMRM|||Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.53|-3.60|0.0088
91563114|NCT02592434|183014209|SUPERIORITY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|1.28||0.0054|TWO_SIDED|95.0|-6.17|-1.1|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.10|-6.17|0.0054
91563115|NCT02592434|183014209|SUPERIORITY||LS mean difference|-3.85|STANDARD_ERROR_OF_MEAN|1.25||0.0039|TWO_SIDED|95.0|-6.38|-1.32|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.32|-6.38|0.0039
91563116|NCT02592434|183014209|SUPERIORITY||LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.98||0.0022|TWO_SIDED|95.0|-5.3|-1.29|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.29|-5.30|0.0022
91563117|NCT02592434|183014209|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.57||0.0005|TWO_SIDED|95.0|-9.42|-3.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-3.00|-9.42|0.0005
91563118|NCT02592434|183014209|SUPERIORITY||LS mean difference|-6.26|STANDARD_ERROR_OF_MEAN|1.63||0.0006|TWO_SIDED|95.0|-9.6|-2.92|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-2.92|-9.60|0.0006
91563119|NCT02592434|183014209|SUPERIORITY||LS mean difference|-4.36|STANDARD_ERROR_OF_MEAN|1.27||0.0027|TWO_SIDED|95.0|-7.02|-1.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.71|-7.02|0.0027
91563120|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.76||0.0172|TWO_SIDED|95.0|-3.32|-0.33|||MMRM|||Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.33|-3.32|0.0172
91563121|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.21||0.0057|TWO_SIDED|95.0|-5.81|-1.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.01|-5.81|0.0057
91563122|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0038|TWO_SIDED|95.0|-5.94|-1.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.23|-5.94|0.0038
91563123|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.01||0.002|TWO_SIDED|95.0|-5.47|-1.36|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.36|-5.47|0.0020
91563124|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-5.66|STANDARD_ERROR_OF_MEAN|1.52||0.0007|TWO_SIDED|95.0|-8.74|-2.57|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.57|-8.74|0.0007
91563125|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|1.49||0.0007|TWO_SIDED|95.0|-8.66|-2.58|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.58|-8.66|0.0007
91563126|NCT02592434|183014211|SUPERIORITY||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|1.25||0.0018|TWO_SIDED|95.0|-6.99|-1.82|||MMRM|||Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.82|-6.99|0.0018
91563127|NCT02592434|183014213|SUPERIORITY||Difference in percentage|1.47||||0.861|TWO_SIDED|95.0|-14.96|17.9|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||17.90|-14.96|0.8610
91563128|NCT02592434|183014213|SUPERIORITY||Difference in percentage|10.12||||0.2173|TWO_SIDED|95.0|-5.96|26.2|||Normal approximation to the binomial|||Week 20||26.20|-5.96|0.2173
91563129|NCT02592434|183014213|SUPERIORITY||Difference in percentage|12.94||||0.1135|TWO_SIDED|95.0|-3.08|28.96|||Normal approximation to the binomial|||Week 24||28.96|-3.08|0.1135
91563130|NCT02592434|183014213|SUPERIORITY||Difference in percentage|11.51||||0.161|TWO_SIDED|95.0|-4.58|27.6|||Normal approximation to the binomial|||Week 28||27.60|-4.58|0.1610
91563131|NCT02592434|183014213|SUPERIORITY||Difference in percentage|7.42||||0.3571|TWO_SIDED|95.0|-8.37|23.21|||Normal approximation to the binomial|||Week 32||23.21|-8.37|0.3571
91563132|NCT02592434|183014213|SUPERIORITY||Difference in percentage|14.44||||0.0716|TWO_SIDED|95.0|-1.27|30.16|||Normal approximation to the binomial|||Week 36||30.16|-1.27|0.0716
91563133|NCT02592434|183014213|SUPERIORITY||Difference in percentage|14.4||||0.0746|TWO_SIDED|95.0|-1.43|30.24|||Normal approximation to the binomial|||Week 40||30.24|-1.43|0.0746
91563134|NCT02592434|183014213|SUPERIORITY||Difference in percentage|14.37||||0.0773|TWO_SIDED|95.0|-1.57|30.3|||Normal approximation to the binomial|||Week 44||30.30|-1.57|0.0773
91563135|NCT02592434|183014215|SUPERIORITY||Difference in percentage|-3.06||||0.5131|TWO_SIDED|95.0|-12.21|6.1|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||6.10|-12.21|0.5131
91563136|NCT02592434|183014215|SUPERIORITY||Difference in percentage|6.87||||0.0876|TWO_SIDED|95.0|-1.01|14.74|||Normal approximation to the binomial|||Week 20||14.74|-1.01|0.0876
91563137|NCT02592434|183014215|SUPERIORITY||Difference in percentage|6.79||||0.1561|TWO_SIDED|95.0|-2.59|16.16|||Normal approximation to the binomial|||Week 24||16.16|-2.59|0.1561
91563138|NCT02592434|183014215|SUPERIORITY||Difference in percentage|2.58||||0.5795|TWO_SIDED|95.0|-6.54|11.7|||Normal approximation to the binomial|||Week 28||11.70|-6.54|0.5795
91563139|NCT02592434|183014215|SUPERIORITY||Difference in percentage|5.4||||0.2435|TWO_SIDED|95.0|-3.67|14.47|||Normal approximation to the binomial|||Week 32||14.47|-3.67|0.2435
91563140|NCT02592434|183014215|SUPERIORITY||Difference in percentage|9.52||||0.0758|TWO_SIDED|95.0|-0.99|20.04|||Normal approximation to the binomial|||Week 36||20.04|-0.99|0.0758
91563141|NCT02592434|183014215|SUPERIORITY||Difference in percentage|10.91||||0.0464|TWO_SIDED|95.0|0.17|21.65|||Normal approximation to the binomial|||Week 40||21.65|0.17|0.0464
91563142|NCT02592434|183014215|SUPERIORITY||Difference in percentage|8.06||||0.1634|TWO_SIDED|95.0|-3.27|19.38|||Normal approximation to the binomial|||Week 44||19.38|-3.27|0.1634
91563143|NCT02592434|183014216|SUPERIORITY||Difference in percentage|-17.42||||0.0062|TWO_SIDED|95.0|-29.88|-4.96|||Normal approximation to the binomial|||Double Blind baseline (Week 18)||-4.96|-29.88|0.0062
91563144|NCT02592434|183014216|SUPERIORITY||Difference in percentage|-0.44||||0.9427|TWO_SIDED|95.0|-12.34|11.47|||Normal approximation to the binomial|||Week 20||11.47|-12.34|0.9427
91563145|NCT02592434|183014216|SUPERIORITY||Difference in percentage|-0.6||||0.9308|TWO_SIDED|95.0|-14.03|12.84|||Normal approximation to the binomial|||Week 24||12.84|-14.03|0.9308
91563146|NCT02592434|183014216|SUPERIORITY||Difference in percentage|0.87||||0.8945|TWO_SIDED|95.0|-12.03|13.78|||Normal approximation to the binomial|||Week 28||13.78|-12.03|0.8945
91563147|NCT02592434|183014216|SUPERIORITY||Difference in percentage|2.22||||0.7455|TWO_SIDED|95.0|-11.2|15.64|||Normal approximation to the binomial|||Week 32||15.64|-11.20|0.7455
91563148|NCT02592434|183014216|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 36||22.72|-4.23|0.1787
91563149|NCT02592434|183014216|SUPERIORITY||Difference in percentage|12.1||||0.0695|TWO_SIDED|95.0|-0.97|25.17|||Normal approximation to the binomial|||Week 40||25.17|-0.97|0.0695
91563150|NCT02592434|183014216|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 44||22.72|-4.23|0.1787
91563151|NCT02592434|183014217|SUPERIORITY||Difference in percentage|-0.12||||0.9719|TWO_SIDED|95.0|-6.74|6.5|||Normal approximation to the binomial|||||6.50|-6.74|0.9719
91563152|NCT02592434|183014219|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.61||0.1595|TWO_SIDED|95.0|-2.08|0.35|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.35|-2.08|0.1595
91563153|NCT02592434|183014219|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.96||0.1421|TWO_SIDED|95.0|-3.32|0.48|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.48|-3.32|0.1421
91563154|NCT02592434|183014219|SUPERIORITY||LS Mean difference|-1.66|STANDARD_ERROR_OF_MEAN|0.83||0.0552|TWO_SIDED|95.0|-3.37|0.04|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-3.37|0.0552
91563155|NCT02592434|183014219|SUPERIORITY||LS Mean difference|-1.17|STANDARD_ERROR_OF_MEAN|0.63||0.0822|TWO_SIDED|95.0|-2.5|0.17|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.17|-2.50|0.0822
91563156|NCT02592434|183014219|SUPERIORITY||LS Mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.22||0.0041|TWO_SIDED|95.0|-6.53|-1.43|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.43|-6.53|0.0041
91563157|NCT02592434|183014219|SUPERIORITY||LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|1.22||0.0085|TWO_SIDED|95.0|-6.12|-1.02|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.02|-6.12|0.0085
91563158|NCT02592434|183014219|SUPERIORITY||LS Mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.03||0.0384|TWO_SIDED|95.0|-4.36|-0.13|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-4.36|0.0384
91563159|NCT02592434|183014221|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.2595|TWO_SIDED|95.0|-0.72|0.19|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.19|-0.72|0.2595
91563160|NCT02592434|183014221|SUPERIORITY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.0674|TWO_SIDED|95.0|-1.42|0.05|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.42|0.0674
91563161|NCT02592434|183014221|SUPERIORITY||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.49||0.058|TWO_SIDED|95.0|-1.93|0.03|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.93|0.0580
91563162|NCT02592434|183014221|SUPERIORITY||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.44||0.0751|TWO_SIDED|95.0|-1.67|0.08|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.08|-1.67|0.0751
91563163|NCT02592434|183014221|SUPERIORITY||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.0251|TWO_SIDED|95.0|-1.88|-0.13|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-1.88|0.0251
91563164|NCT02592434|183014221|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.49||0.0331|TWO_SIDED|95.0|-2.07|-0.09|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.09|-2.07|0.0331
91563165|NCT02592434|183014221|SUPERIORITY||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.42||0.0549|TWO_SIDED|95.0|-1.66|0.02|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-1.66|0.0549
91563166|NCT02592434|183014223|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.0353|TWO_SIDED|95.0|-1.04|-0.04|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.04|-1.04|0.0353
91563167|NCT02592434|183014223|SUPERIORITY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.32||0.0094|TWO_SIDED|95.0|-1.47|-0.21|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.21|-1.47|0.0094
91563168|NCT02592434|183014223|SUPERIORITY||LS Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0065|TWO_SIDED|95.0|-1.36|-0.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.23|-1.36|0.0065
91563169|NCT02592434|183014223|SUPERIORITY||LS Mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27||0.0018|TWO_SIDED|95.0|-1.43|-0.34|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.43|0.0018
91563170|NCT02592434|183014223|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|-2.24|-0.61|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.61|-2.24|0.0010
91563171|NCT02592434|183014223|SUPERIORITY||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.4||0.0002|TWO_SIDED|95.0|-2.42|-0.81|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.81|-2.42|0.0002
91563172|NCT02592434|183014223|SUPERIORITY||LS Mean difference|-1.58|STANDARD_ERROR_OF_MEAN|0.43||0.0007|TWO_SIDED|95.0|-2.44|-0.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.71|-2.44|0.0007
91563173|NCT02592434|183014225|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0398|TWO_SIDED|95.0|-0.83|-0.02|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.02|-0.83|0.0398
91563174|NCT02592434|183014225|SUPERIORITY||LS Mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.28||0.0011|TWO_SIDED|95.0|-1.49|-0.39|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.39|-1.49|0.0011
91563175|NCT02592434|183014225|SUPERIORITY||LS mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0131|TWO_SIDED|95.0|-1.47|-0.18|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.47|0.0131
91563176|NCT02592434|183014225|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.0039|TWO_SIDED|95.0|-1.62|-0.33|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.33|-1.62|0.0039
91563177|NCT02592434|183014225|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.29||0.0711|TWO_SIDED|95.0|-1.1|0.05|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.10|0.0711
91563178|NCT02592434|183014225|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0658|TWO_SIDED|95.0|-1.3|0.04|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-1.30|0.0658
91563179|NCT02592434|183014225|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.29||0.0154|TWO_SIDED|95.0|-1.31|-0.15|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.15|-1.31|0.0154
91563180|NCT02592434|183014227|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4777|TWO_SIDED|95.0|-0.12|0.06|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.06|-0.12|0.4777
91563181|NCT02592434|183014227|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0779|TWO_SIDED|95.0|-0.16|0.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.16|0.0779
91563182|NCT02592434|183014227|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0324|TWO_SIDED|95.0|-0.19|-0.01|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.19|0.0324
91563183|NCT02592434|183014227|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.1061|TWO_SIDED|95.0|-0.2|0.02|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-0.20|0.1061
91563184|NCT02592434|183014227|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0572|TWO_SIDED|95.0|-0.24|0.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.00|-0.24|0.0572
91563185|NCT02592434|183014227|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.0689|TWO_SIDED|95.0|-0.24|0.01|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.24|0.0689
91563186|NCT02592434|183014227|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.22|0.0292
91563187|NCT02592434|183014229|SUPERIORITY||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|3.77||0.3179|TWO_SIDED|95.0|-3.72|11.31|||MMRM|||Global Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.31|-3.72|0.3179
91563188|NCT02592434|183014229|SUPERIORITY||LS mean difference|3.28|STANDARD_ERROR_OF_MEAN|4.27||0.4452|TWO_SIDED|95.0|-5.23|11.78|||MMRM|||Physical Functioning: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.78|-5.23|0.4452
91563189|NCT02592434|183014229|SUPERIORITY||LS mean difference|5.47|STANDARD_ERROR_OF_MEAN|4.76||0.2539|TWO_SIDED|95.0|-4.01|14.95|||MMRM|||Social Limitations: Emotional: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||14.95|-4.01|0.2539
91563190|NCT02592434|183014229|SUPERIORITY||LS mean difference|7.22|STANDARD_ERROR_OF_MEAN|5.56||0.1981|TWO_SIDED|95.0|-3.86|18.3|||MMRM|||Social Limitations: Physical Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||18.30|-3.86|0.1981
91563191|NCT02592434|183014229|SUPERIORITY||LS mean difference|8.26|STANDARD_ERROR_OF_MEAN|4.36||0.062|TWO_SIDED|95.0|-0.43|16.94|||MMRM|||Bodily Pain: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||16.94|-0.43|0.0620
91563192|NCT02592434|183014229|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.83||0.2291|TWO_SIDED|95.0|-9.06|2.2|||MMRM|||Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.20|-9.06|0.2291
91563193|NCT02592434|183014229|SUPERIORITY||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|3.9||0.353|TWO_SIDED|95.0|-11.43|4.13|||MMRM|||Global Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||4.13|-11.43|0.3530
91563194|NCT02592434|183014229|SUPERIORITY||LS mean difference|-3.47|STANDARD_ERROR_OF_MEAN|3.41||0.3114|TWO_SIDED|95.0|-10.26|3.32|||MMRM|||Mental Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||3.32|-10.26|0.3114
91563195|NCT02592434|183014229|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|4.46||0.8736|TWO_SIDED|95.0|-8.18|9.61|||MMRM|||Self Esteem: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||9.61|-8.18|0.8736
91563196|NCT02592434|183014229|SUPERIORITY||LS mean difference|1.77|STANDARD_ERROR_OF_MEAN|2.48||0.4778|TWO_SIDED|95.0|-3.18|6.72|||MMRM|||General Health Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||6.72|-3.18|0.4778
91563197|NCT02592434|183014229|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8909|TWO_SIDED|95.0|-0.28|0.25|||MMRM|||Change in Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||0.25|-0.28|0.8909
91563198|NCT02592434|183014229|SUPERIORITY||LS mean difference|8.97|STANDARD_ERROR_OF_MEAN|5.81||0.127|TWO_SIDED|95.0|-2.61|20.55|||MMRM|||Emotional Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||20.55|-2.61|0.1270
91563199|NCT02592434|183014229|SUPERIORITY||LS mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.96||0.0944|TWO_SIDED|95.0|-14.62|1.18|||MMRM|||Time Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||1.18|-14.62|0.0944
91563200|NCT02592434|183014229|SUPERIORITY||LS mean difference|-8.6|STANDARD_ERROR_OF_MEAN|3.23||0.0095|TWO_SIDED|95.0|-15.03|-2.17|||MMRM|||Family Activities: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.17|-15.03|0.0095
91563201|NCT02592434|183014229|SUPERIORITY||LS mean difference|2.59|STANDARD_ERROR_OF_MEAN|4.29||0.5474|TWO_SIDED|95.0|-5.96|11.14|||MMRM|||Family Cohesion: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.14|-5.96|0.5474
91563202|NCT02592434|183014229|SUPERIORITY||LS mean difference|3.48|STANDARD_ERROR_OF_MEAN|2.03||0.0902|TWO_SIDED|95.0|-0.56|7.52|||MMRM|||Physical Health Summary: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||7.52|-0.56|0.0902
91563203|NCT02592434|183014229|SUPERIORITY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|1.67||0.6539|TWO_SIDED|95.0|-4.07|2.57|||MMRM|||Psychosocial Health Summary : Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.57|-4.07|0.6539
91563204|NCT02592434|183014231|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.1894|TWO_SIDED|95.0|-0.8|0.16|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.16|-0.80|0.1894
91563205|NCT02592434|183014231|SUPERIORITY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.31||0.0026|TWO_SIDED|95.0|-1.56|-0.34|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.56|0.0026
91563206|NCT02592434|183014231|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.31||0.0067|TWO_SIDED|95.0|-1.5|-0.25|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.50|0.0067
91563207|NCT02592434|183014231|SUPERIORITY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.37||0.0091|TWO_SIDED|95.0|-1.73|-0.25|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.73|0.0091
91563208|NCT02592434|183014231|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.0632|TWO_SIDED|95.0|-1.09|0.03|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.09|0.0632
91563209|NCT02592434|183014231|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.32||0.0306|TWO_SIDED|95.0|-1.35|-0.07|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.07|-1.35|0.0306
91563210|NCT02592434|183014231|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0118|TWO_SIDED|95.0|-1.41|-0.18|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.41|0.0118
91563211|NCT00147745|183014261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5499||95.0|-0.1|0.19|||ANCOVA|||||0.19|-0.10|0.5499
91563212|NCT00147745|183014261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5723||95.0|-0.23|0.13|||ANCOVA|||||0.13|-0.23|0.5723
91563213|NCT00147745|183014261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.091||0.3138||95.0|-0.09|0.28|||ANCOVA|||||0.28|-0.09|0.3138
91563214|NCT00147745|183014262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.065||0.2042||95.0|-0.05|0.22|||ANCOVA|||||0.22|-0.05|0.2042
91563215|NCT00147745|183014262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.083||0.6855||95.0|-0.2|0.14|||ANCOVA|||||0.14|-0.20|0.6855
91769362|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|1.9||||0.738|TWO_SIDED|95.0|-9.59|13.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||13.45|-9.59|0.738
91769363|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|-5.4||||0.412|TWO_SIDED|95.0|-18.32|7.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||7.60|-18.32|0.412
91769364|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|3.9||||0.534|TWO_SIDED|95.0|-8.56|16.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||16.36|-8.56|0.534
91769365|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|11.0||||0.052|TWO_SIDED|95.0|-0.1|22.01||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||22.01|-0.10|0.052
91769366|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|-13.9||||0.027|TWO_SIDED|95.0|-26.15|-1.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders||-1.63|-26.15|0.027
91769367|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|-1.0||||0.928|TWO_SIDED|95.0|-24.02|21.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.97|-24.02|0.928
91769368|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|-2.5||||0.658|TWO_SIDED|95.0|-13.72|8.77||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||8.77|-13.72|0.658
91563216|NCT00147745|183014262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085||0.1727||95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|0.1727
91769369|NCT02365649|183425739|SUPERIORITY||LS Mean of Difference|-3.5||||0.601|TWO_SIDED|95.0|-16.96|9.96||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||9.96|-16.96|0.601
91769370|NCT02365649|183425741|SUPERIORITY||Risk Difference (RD)|-50.0||||1|TWO_SIDED|95.0|-99.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-1.0|-99.0|1.000
91769371|NCT02365649|183425741|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
91769372|NCT02365649|183425741|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
91769373|NCT02365649|183425741|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
91769374|NCT02365649|183425742|SUPERIORITY||Risk Difference (RD)|-66.7||||1|TWO_SIDED|95.0|-100.0|-13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-13.3|-100.0|1.000
91563217|NCT00147745|183014263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.4|STANDARD_ERROR_OF_MEAN|53.17||0.4104||95.0|-152.8|64.1|||ANCOVA|||||64.1|-152.8|0.4104
91563218|NCT00147745|183014263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|69.98||0.8857||95.0|-132.6|152.9|||ANCOVA|||||152.9|-132.6|0.8857
91563219|NCT00147745|183014263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.5|STANDARD_ERROR_OF_MEAN|67.08||0.4226||95.0|-191.3|82.3|||ANCOVA|||||82.3|-191.3|0.4226
91563220|NCT00147745|183014264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.366||0.2286||95.0|-1.2|0.3|||ANCOVA|||||0.30|-1.20|0.2286
91563221|NCT00147745|183014264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.515||0.3184||95.0|-0.53|1.57|||ANCOVA|||||1.57|-0.53|0.3184
91563222|NCT00147745|183014264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0613||95.0|-1.99|0.05|||ANCOVA|||||0.05|-1.99|0.0613
91563223|NCT00147745|183014265|SUPERIORITY_OR_OTHER|||||||0.0362||95.0|||||t-test, 2 sided|||||||0.0362
91563224|NCT02100189|183014276|SUPERIORITY_OR_OTHER||Sensitivity|13.3|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|3.76|30.72|||Sensitivity||Exact Binomial confidence interval.|||30.72|3.76|
91563225|NCT02100189|183014277|SUPERIORITY_OR_OTHER||Specificity|94.7|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|73.97|99.87|||Specificity||Exact binomial confidence interval|||99.87|73.97|
91563226|NCT00515281|183014350|SUPERIORITY|||||||0.017|||||||Chi-squared|||||||0.017
91563227|NCT00515281|183014351|SUPERIORITY|||||||0.288|||||||Chi-squared|||||||0.288
91563228|NCT00515281|183014352|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
91563229|NCT00515281|183014353|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
91563230|NCT00515281|183014354|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
91563231|NCT00515281|183014355|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91563232|NCT00515281|183014356|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
91563233|NCT04016415|183014381|SUPERIORITY|Two-sided tests with the null hypothesis of no difference in chg from Baseline to 6MO between the two arms. The power calculation assumed a clinically meaningful diff of 0.5% and standard deviation of 0.9%. Assuming an avg class cohort size of 18 pts and an intraclass correlation coefficient estimate of 0.08 for correlation within cohorts yielded a design effect that inflated the sample size by 1+((18-1) multiplied by 0.08)=2.36. A 15% dropout rate was assumed. 145 pts per arm yielded 80% power.|Mean Difference (Net)|-0.01||||0.96|TWO_SIDED|95.0|-0.36|0.34||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.34|-0.36|0.96
91563234|NCT04016415|183014382|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|-0.07||||0.68|TWO_SIDED|95.0|-0.38|0.25||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.25|-0.38|0.68
91563235|NCT04016415|183014383|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|0.06||||0.41|TWO_SIDED|95.0|-0.09|0.21||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.21|-0.09|0.41
91563236|NCT04016415|183014384|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.22|0.12||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.12|-0.22|0.59
91563237|NCT04016415|183014385|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|1.57||||0.04|TWO_SIDED|95.0|0.07|3.06||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||3.06|0.07|0.04
91563238|NCT04016415|183014386|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|0.83||||0.3|TWO_SIDED|95.0|-0.74|2.4||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||2.40|-0.74|0.30
91769375|NCT02365649|183425742|SUPERIORITY||Risk Difference (RD)|33.3||||0.25|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||86.7|-20.0|0.250
91563239|NCT00828178|183014387|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.||||0.87
91563240|NCT00828178|183014388|SUPERIORITY_OR_OTHER|||||||0.1801||||||This Statistical Analysis applies category SELENA-SLEDAI|t-test, 2 sided|||||||0.1801
91563241|NCT01885559|183014390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.58|TWO_SIDED|95.0|0.82|1.42|||Regression, Cox|Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site|ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)|||1.42|0.82|0.58
91563242|NCT01885559|183014391|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.88|TWO_SIDED|95.0|-3.2|2.8|||shared parameter model|shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint||||2.8|-3.2|0.88
91563243|NCT01885559|183014392|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.17|TWO_SIDED|95.0|-3.9|0.7||controlling for age, sex, race, and clinical site|Mixed Models Analysis||ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change|||0.7|-3.9|0.17
91563244|NCT01885559|183014393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.85|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|adjusting for age, sex, race, and clinical site and recurrent events|Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo|||1.32|0.80|0.85
91563245|NCT01885559|183014394|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.57|TWO_SIDED|95.0|0.42|1.6|||Regression, Cox|adjusting for age, sex, race, and clinical site and accounting for recurrent events|Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo|||1.6|0.42|0.57
91563246|NCT01885559|183014395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.032||||0.75|TWO_SIDED|95.0|-0.23|0.16|||shared parameter model|Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.||||0.16|-0.23|0.75
91563247|NCT01885559|183014396|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.66|TWO_SIDED|95.0|-0.26|0.16|||shared parameter model|Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.||||0.16|-0.26|0.66
91563248|NCT01885559|183014397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||0.64|TWO_SIDED|95.0|0.99|1.01|||Mixed Models Analysis|Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.|"Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.~ACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01)."|||1.01|0.99|0.64
91563249|NCT02168855|183014403|SUPERIORITY||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.29|||Regression, Logistic|This is a logistic regression model of the active versus placebo arm, while controlling for age and cigarettes smoked per day at enrollment.|The active arm is the numerator and the placebo arm is the denominator of the odds ratio|||3.29|0.58|0.46
91563250|NCT02168855|183014404|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.0001|TWO_SIDED|95.0|1.83|1.98|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in craving. Temptations are the numerator and background is the denominator.|||1.98|1.83|<0.0001
91563251|NCT02168855|183014405|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.0001|TWO_SIDED|95.0|1.51|1.83|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in negative affect T-score. Temptations are the numerator and background is the denominator.|||1.83|1.51|<0.0001
91563252|NCT02168855|183014406|SUPERIORITY||Odds Ratio (OR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.14|0.21|||Regression, Logistic|Includes random subject intercept effect|Odds ratio where temptations are the numerator and background is the denominator, that no smoking cues were seen.|||0.21|0.14|<0.0001
91769376|NCT02365649|183425742|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||95.6|-62.2|1.000
91563253|NCT02168855|183014407|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.23|||Regression, Logistic||Odds ratio where temptations are the numerator and background is the denominator, that no other people were seen smoking nearby.|||0.23|0.15|<0.0001
91563254|NCT03000829|183014408|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
91563255|NCT03000829|183014409|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
91563256|NCT03000829|183014410|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
91563257|NCT03000829|183014411|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
91563258|NCT03000829|183014412|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
91563259|NCT03000829|183014413|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
91769377|NCT02365649|183425742|SUPERIORITY||Risk Difference (RD)|-33.3||||0.5|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|0.500
91563260|NCT03000829|183014414|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91563261|NCT03000829|183014415|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
91563262|NCT03000829|183014418|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
91563263|NCT03677986|183014428|SUPERIORITY||Odds Ratio (OR)|0.92||||0.914|TWO_SIDED|95.0|0.21|4.14|||GEE|||||4.14|.21|0.914
91563264|NCT00424502|183014430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.017|STANDARD_DEVIATION|1.34|<|0.0001|TWO_SIDED|95.0|1.39|2.64|||t-test, 2 sided|||Change from Baseline to Week 24||2.64|1.39|<0.0001
91563265|NCT00424502|183014431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_DEVIATION|0.259|<|0.0001|TWO_SIDED|95.0|0.151|0.401|||t-test, 2 sided|||Change from baseline to Week 24||0.401|0.151|<0.0001
91563266|NCT00424502|183014434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|STANDARD_DEVIATION|23.24||0.012|TWO_SIDED|95.0|3.52|25.28|||t-test, 2 sided|||Change from baseline to Week 24||25.28|3.52|0.012
91563267|NCT00424502|183014435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_DEVIATION|8.21||0.337|TWO_SIDED|95.0|-2.03|5.65|||t-test, 2 sided|||Change from baseline to Week 24||5.65|-2.03|0.337
91563268|NCT00635609|183014442|SUPERIORITY_OR_OTHER|||||||0.765||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.765
91563269|NCT00635609|183014443|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.290
91563270|NCT00635609|183014444|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.033
91563271|NCT01232569|183014498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.5|||<|0.001|TWO_SIDED|95.0|22.0|37.0|||Cochran-Mantel-Haenszel|Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).||||37.0|22.0|<0.001
91563272|NCT04044352|183014516|OTHER|Likelihood ratio test was the statistical test.|Odds Ratio (OR)|0.81||||0.126|TWO_SIDED|95.0|0.62|1.06|||Wald Chi-Square||A two-fold increase in HAI pre-challenge titer (i.e. one unit increase in log-2 titer) corresponds to a 19% decrease in the odds of developing MMID during the study challenge period (Day 2 through Day 8).|Pre-challenge (baseline) HAI geometric mean titer was log-2 transformed and treated as a continuous variable in the model.||1.06|0.62|0.126
91563273|NCT02123797|183014594|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0007|TWO_SIDED|95.0|1.35|3.06||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive stage confirmation (numerator=108/70) to Serial Care patients with and without invasive stage confirmation (denominator=168/180) after adjustment for matched study.|||3.06|1.35|0.0007
91563274|NCT02123797|183014595|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0022|TWO_SIDED|95.0|1.25|2.8||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive mediastinal staging (numerator=91/87) to Serial Care patients with and without mediastinal invasive staging (denominator=126/222) after adjustment for matched study.|||2.80|1.25|0.0022
91563275|NCT02123797|183014596|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0004|TWO_SIDED|95.0|1.67|5.85||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients with and without bi-modal staging (denominator=267/81) after adjustment for matched study design.|||5.85|1.67|0.0004
91563276|NCT02123797|183014597|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.5|3.36||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients with and without tri-modal staging (denominator=132/216) after adjustment for matched study design.|||3.36|1.50|<0.0001
91769378|NCT02365649|183425742|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|1.000
91769379|NCT01506271|183425743|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|1.1|||<|0.001|TWO_SIDED|95.0|-6.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|MK-7655 250 mg - Placebo: Percentage Difference||8.6|-6.2|< 0.001
91563277|NCT02123797|183014598|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0366|TWO_SIDED|95.0|1.665|3.996||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive staging (numerator=108/70) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||3.996|1.665|0.0366
91563278|NCT02123797|183014598|SUPERIORITY||Odds Ratio (OR)|2.621||||0.0779|TWO_SIDED|95.0|1.473|4.665||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without invasive staging (numerator=46/30) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||4.665|1.473|0.0779
91563279|NCT02123797|183014599|SUPERIORITY||Odds Ratio (OR)|2.358||||0.0703|TWO_SIDED|95.0|1.536|3.621||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without mediastinal staging (numerator=91/87) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||3.621|1.536|0.0703
91769380|NCT01506271|183425743|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|3.7|||<|0.001|TWO_SIDED|95.0|-2.0|10.8|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.8|-2.0|< 0.001
91769381|NCT01506271|183425744|OTHER|Test for a non-zero difference.|Percentage Difference|0.0||||0.979|TWO_SIDED|95.0|-4.7|4.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.5|-4.7|0.979
91769382|NCT01506271|183425744|OTHER|Test for a non-zero difference.|Percentage Difference|-1.8||||0.153|TWO_SIDED|95.0|-6.2|1.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||1.5|-6.2|0.153
91769383|NCT01506271|183425745|OTHER|Test for a non-zero difference.|Percentage Difference|0.9||||0.324|TWO_SIDED|95.0|-2.4|4.7|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.7|-2.4|0.324
91769384|NCT01506271|183425745|OTHER|Test for a non-zero difference|Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.3|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||3.2|-3.3|> 0.999
91769385|NCT01506271|183425746|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|7.5|||||TWO_SIDED|95.0|-5.4|20.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||20.1|-5.4|
91769386|NCT01506271|183425746|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|6.2|||||TWO_SIDED|95.0|-6.7|18.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||18.8|-6.7|
91769387|NCT01506271|183425747|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-10.3|2.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.4|-10.3|
91769388|NCT01506271|183425747|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-5.0|10.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.1|-5.0|
91769389|NCT01506271|183425748|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.0|||||TWO_SIDED|95.0|-4.5|12.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||12.7|-4.5|
91769390|NCT01506271|183425748|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-4.4|12.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||12.8|-4.4|
91769391|NCT01506271|183425749|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.0|3.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||3.9|-4.0|
91769392|NCT01506271|183425749|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.8|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-4.8|
91769393|NCT01506271|183425750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.3|-6.7|
91769394|NCT01506271|183425750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||7.4|-3.7|
91769395|NCT01506271|183425751|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.6|||||TWO_SIDED|95.0|-7.5|0.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0.6|-7.5|
91769396|NCT01506271|183425751|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-6.7|
91769397|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.7|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Diarrhoea||8.1|-4.7|
91769398|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.6|8.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Diarrhoea||8.2|-4.6|
91769399|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nausea||6.9|-7.3|
91769400|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nausea||8.0|-6.5|
91769401|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|3.4|||||TWO_SIDED|95.0|-2.3|9.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vomiting||9.6|-2.3|
91769402|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.1|||||TWO_SIDED|95.0|-0.7|11.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vomiting||11.8|-0.7|
91769403|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.6|3.5|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Postoperative Infection||3.5|-7.6|
91769404|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Postoperative Infection||2.2|-8.4|
91769405|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.9|||||TWO_SIDED|95.0|-2.4|4.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Seroma||4.7|-2.4|
91769406|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.3|||||TWO_SIDED|95.0|1.0|9.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Seroma||9.7|1.0|
91769407|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-5.0|6.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - ALT increased||6.6|-5.0|
91769408|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.9|6.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - ALT increased||6.7|-4.9|
91563280|NCT02123797|183014599|SUPERIORITY||Odds Ratio (OR)|2.535||||0.0631|TWO_SIDED|95.0|1.446|4.444||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without mediastinal staging (numerator=40/36) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||4.444|1.446|0.0631
91563281|NCT02123797|183014600|SUPERIORITY||Odds Ratio (OR)|3.191||||0.001|TWO_SIDED|95.0|1.671|6.093||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||6.093|1.671|0.0010
91563282|NCT02123797|183014600|SUPERIORITY||Odds Ratio (OR)|1.103||||0.1972|TWO_SIDED|95.0|0.526|2.314||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without bi-modal staging (numerator=62/14) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||2.314|0.526|0.1972
91563283|NCT02123797|183014601|SUPERIORITY||Odds Ratio (OR)|2.739||||0.0055|TWO_SIDED|95.0|1.785|4.203|||Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||4.203|1.785|0.0055
91563284|NCT02123797|183014601|SUPERIORITY||Odds Ratio (OR)|2.242||||0.2572|TWO_SIDED|95.0|1.287|3.905||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without tri-modal staging (numerator=39/37) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||3.905|1.287|0.2572
91563285|NCT02123797|183014602|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0045|TWO_SIDED|95.0|1.24|3.25||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients with and without stage appropriate treatment (denominator=232/106) after adjustment for matched study.|||3.25|1.24|0.0045
91563286|NCT02123797|183014603|SUPERIORITY||Odds Ratio (OR)|2.249||||0.0474|TWO_SIDED|95.0|1.368|3.699||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|We examined treatment selection practices with or without MD care in a single healthcare system.||3.699|1.368|0.0474
91563287|NCT02123797|183014603|SUPERIORITY||Odds Ratio (OR)|1.751||||0.6353|TWO_SIDED|95.0|0.91|3.37||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing SC patients in conference with and without stage appropriate treatment (numerator=58/15) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|||3.370|0.910|0.6353
91563288|NCT02123797|183014605|SUPERIORITY||Odds Ratio (OR)|2.955||||0.0014|TWO_SIDED|95.0|1.52|5.747||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=140/37) to SC conference patients with and without concordance to recommendations (denominator=45/30) after adjustment for matched study design.|||5.747|1.520|0.0014
91769409|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-3.7|7.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - AST increased||7.3|-3.7|
91563289|NCT02123797|183014606|SUPERIORITY||Odds Ratio (OR)|3.093||||0.0019|TWO_SIDED|95.0|1.519|6.299||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=145/32) to SC conference patients with and without concordance to recommendations (denominator=49/26) after adjustment for matched study design.|||6.299|1.519|0.0019
91563290|NCT02123797|183014607|SUPERIORITY||Odds Ratio (OR)|40.892||||0.0499|TWO_SIDED|95.0|1.002|999.999||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=174/3) to SC conference patients with and without concordance to recommendations (denominator=71/4) after adjustment for matched study design.|||999.999|1.002|0.0499
91563291|NCT02123797|183014608|SUPERIORITY||Odds Ratio (OR)|2.663||||0.0263|TWO_SIDED|95.0|1.123|6.319||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=158/19) to SC conference patients with and without concordance to recommendations (denominator=60/15) after adjustment for matched study design.|||6.319|1.123|0.0263
91563292|NCT02123797|183014609|SUPERIORITY||Odds Ratio (OR)|2.566||||0.1503|TWO_SIDED|95.0|0.711|9.269||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=87/14) to SC conference patients with and without concordance to recommendations (denominator=38/8) after adjustment for matched study design.|||9.269|0.711|0.1503
91563293|NCT02123797|183014622|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0042
91563294|NCT02123797|183014622|SUPERIORITY|||||||0.0805|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.0805
91769410|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - AST increased||7.4|-3.7|
91769411|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.5|4.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Lipase increased||4.2|-6.5|
91563295|NCT02123797|183014622|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0073
91563296|NCT02123797|183014622|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0579
91563297|NCT02123797|183014623|SUPERIORITY|||||||0.0146|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0146
91563298|NCT02123797|183014623|SUPERIORITY|||||||0.16|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.16
91769412|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Lipase increased||3.0|-7.2|
91769413|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.5|||||TWO_SIDED|95.0|-8.7|-0.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Hypertension||-0.3|-8.7|
91563299|NCT02123797|183014623|SUPERIORITY|||||||0.0014|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0014
91563300|NCT02123797|183014623|SUPERIORITY|||||||0.0037|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0037
91563301|NCT02123797|183014630|SUPERIORITY|||||||0.7506|||||||Log Rank|||||||0.7506
91563302|NCT02123797|183014630|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.54|TWO_SIDED|95.0|0.85|1.36|||Regression, Cox||Comparison is Multidisciplinary/Serial Care.|||1.36|0.85|0.54
91563303|NCT02123797|183014631|SUPERIORITY|||||||0.4847|||||||Log Rank|||||||0.4847
91563304|NCT02123797|183014631|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.87|1.43|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.43|0.87|0.51
91563305|NCT02123797|183014631|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.51|TWO_SIDED|95.0|0.84|1.67|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.67|0.84|0.51
91563306|NCT02123797|183014632|SUPERIORITY|||||||0.9874|||||||Log Rank|||||||0.9874
91563307|NCT02123797|183014632|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8|TWO_SIDED|95.0|0.82|1.29|||Regression, Cox||Comparison is Multidisciplinary/Serial Care|||1.29|0.82|0.80
91563308|NCT02123797|183014633|SUPERIORITY|||||||0.5377|||||||Log Rank|||||||0.5377
91563309|NCT02123797|183014633|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.83|1.34|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.34|0.83|0.73
91563310|NCT02123797|183014633|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.73|TWO_SIDED|95.0|0.82|1.57|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.57|0.82|0.73
91563311|NCT01375777|183014643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.23|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-54.52|-39.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-39.93|-54.52|<0.001
91563312|NCT01375777|183014643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.17|STANDARD_ERROR_OF_MEAN|3.66|<|0.001||95.0|-47.38|-32.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-32.95|-47.38|<0.001
91563313|NCT01375777|183014643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.27|STANDARD_ERROR_OF_MEAN|3.68|<|0.001|TWO_SIDED|95.0|-44.53|-30.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-30.02|-44.53|<0.001
91769414|NCT01506271|183425752|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.4|4.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Hypertension||4.3|-6.4|
91769415|NCT01506271|183425753|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0|0|> 0.999
91769416|NCT01506271|183425753|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||0|0|> 0.999
91563314|NCT01375777|183014643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.53|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-59.67|-45.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-45.38|-59.67|<0.001
91563315|NCT01375777|183014643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-54.89|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-40.60|-54.89|<0.001
91563316|NCT01375777|183014643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.57|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-50.71|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.42|-50.71|<0.001
91563317|NCT01375777|183014644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.9|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|-76.3|-55.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-55.6|-76.3|<0.001
91563318|NCT01375777|183014644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001||95.0|-73.2|-52.2||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-52.2|-73.2|<0.001
91769417|NCT01506271|183425754|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.4||||0.001|TWO_SIDED|95.0|-9.1|6.0|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.0|-9.1|0.001
91563319|NCT01375777|183014644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.3|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-62.7|-41.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-41.9|-62.7|<0.001
91563320|NCT01375777|183014644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-72.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-82.2|-62.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-62.4|-82.2|<0.001
91769418|NCT01506271|183425754|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-2.1||||0.002|TWO_SIDED|95.0|-9.7|5.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||5.3|-9.7|0.002
91769419|NCT01506271|183425755|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-6.3|6.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.2|-6.3|< 0.001
91563321|NCT01375777|183014644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-63.9|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-73.9|-54.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-54.0|-73.9|<0.001
91563322|NCT01375777|183014644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-70.7|-50.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-50.9|-70.7|<0.001
91563323|NCT01375777|183014645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.15|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.72|-38.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.58|-51.72|<0.001
91563324|NCT01375777|183014645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.79|STANDARD_ERROR_OF_MEAN|3.29|<|0.001||95.0|-43.29|-30.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.29|-43.29|<0.001
91563325|NCT01375777|183014645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.06|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-41.59|-28.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.52|-41.59|<0.001
91563326|NCT01375777|183014645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.11|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-53.33|-40.89||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-40.89|-53.33|<0.001
91563327|NCT01375777|183014645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.89|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-48.11|-35.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-35.67|-48.11|<0.001
91563328|NCT01375777|183014645|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.7|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-43.92|-31.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.47|-43.92|<0.001
91769420|NCT01506271|183425755|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|2.4|||<|0.001|TWO_SIDED|95.0|-2.0|8.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.3|-2.0|< 0.001
91769421|NCT01506271|183425756|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.7|6.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.4|-6.7|< 0.001
91563329|NCT01375777|183014646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.19|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-50.45|-37.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-37.94|-50.45|<0.001
91563330|NCT01375777|183014646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.87|STANDARD_ERROR_OF_MEAN|3.13|<|0.001||95.0|-42.06|-29.69||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.69|-42.06|<0.001
91563331|NCT01375777|183014646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.33|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-38.55|-26.11||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.11|-38.55|<0.001
91563332|NCT01375777|183014646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.48|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-48.63|-36.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-36.32|-48.63|<0.001
91563333|NCT01375777|183014646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-44.07|-31.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.76|-44.07|<0.001
91563334|NCT01375777|183014646|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.22|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-39.38|-27.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-27.07|-39.38|<0.001
91563335|NCT01375777|183014647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.49|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-43.43|-31.54||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.54|-43.43|<0.001
91563336|NCT01375777|183014647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.92|STANDARD_ERROR_OF_MEAN|2.98|<|0.001||95.0|-37.79|-26.04||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.04|-37.79|<0.001
91563337|NCT01375777|183014647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.86|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-34.77|-22.95||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.95|-34.77|<0.001
91563338|NCT01375777|183014647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.58|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-42.29|-30.88||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.88|-42.29|<0.001
91563339|NCT01375777|183014647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-36.92|-25.51||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-25.51|-36.92|<0.001
91563340|NCT01375777|183014647|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.69|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-34.39|-22.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.98|-34.39|<0.001
91563341|NCT01375777|183014648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.16|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-56.75|-43.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-43.58|-56.75|<0.001
91563342|NCT01375777|183014648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|3.3|<|0.001||95.0|-46.84|-33.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.82|-46.84|<0.001
91563343|NCT01375777|183014648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.83|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-41.38|-28.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.28|-41.38|<0.001
91563344|NCT01375777|183014648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.47|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-52.12|-38.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.82|-52.12|<0.001
91769422|NCT01506271|183425756|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.1|||<|0.001|TWO_SIDED|95.0|-6.3|6.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||6.5|-6.3|< 0.001
91769423|NCT01506271|183425757|NON_INFERIORITY|Non-inferiority test based on Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.3||||0.002|TWO_SIDED|95.0|-9.6|6.9|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.9|-9.6|0.002
91769424|NCT01506271|183425757|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-7.2|8.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.2|-7.2|< 0.001
91563345|NCT01375777|183014648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.57|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-47.22|-33.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.92|-47.22|<0.001
91563346|NCT01375777|183014648|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.25|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-42.9|-29.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.60|-42.90|<0.001
91769425|NCT01506271|183425758|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-7.4|7.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||7.4|-7.4|< 0.001
91563347|NCT00376935|183014659|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-9.0||||0.1996|ONE_SIDED|98.4||14.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.||14||0.1996
91563348|NCT00376935|183014659|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3135|ONE_SIDED|98.4||17.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.||17||0.3135
91563349|NCT00376935|183014659|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3662|ONE_SIDED|98.4||22.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.||22||0.3662
91563350|NCT03602053|183014669|NON_INFERIORITY|If the lower limit of the 95% CI of the ratio of GMCs between the ROTAVAC 5D® and ROTAVAC® groups was larger than 1/2 (i.e. \> 0.5), ROTAVAC 5D® would be considered non-inferior to ROTAVAC®.|GMC ratio|1.294|||||TWO_SIDED|95.0|0.862|1.924|||t-test, 2 sided|||||1.924|0.862|
91563351|NCT01234675|183014690|SUPERIORITY||Paired difference|4.6||||0.424|TWO_SIDED|95.0|-7.3|16.6|||Paired T test|||||16.6|-7.3|0.424
91563352|NCT01234675|183014691|SUPERIORITY||Paired difference|-6.1||||0.049|TWO_SIDED|95.0|-12.2|-0.04|||Paired T test|||||-0.04|-12.2|0.049
91563353|NCT01234675|183014692|SUPERIORITY||Paired difference|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Paired T test|||||45.8|-0.6|0.056
91563354|NCT01234675|183014693|SUPERIORITY||Paired difference|-6.1||||0.683|TWO_SIDED|95.0|-12.5|18.5|||Paired T test|||||18.5|-12.5|0.683
91563355|NCT01234675|183014694|SUPERIORITY||Paired difference|-1.502||||0.155|TWO_SIDED|95.0|-59.1|10.4|||Paired T test|||||10.4|-59.1|0.155
91563356|NCT01234675|183014695|SUPERIORITY||Paired difference|-1.0||||0.805|TWO_SIDED|95.0|-9.8|7.8|||Paired T test|||||7.8|-9.8|0.805
91563357|NCT01234675|183014696|SUPERIORITY||Paired difference|-1.0||||0.844|TWO_SIDED|95.0|-11.6|9.6|||Paired T test|||||9.6|-11.6|0.844
91563358|NCT01234675|183014697|SUPERIORITY||Paired difference|2.9||||0.509|TWO_SIDED|95.0|-6.4|12.2|||Paired T test|||||12.2|-6.4|0.509
91563359|NCT01234675|183014698|SUPERIORITY||Paired difference|0.32||||0.3|TWO_SIDED|95.0|-0.3|0.6|||Paired T test|||||0.6|-0.3|0.3
91563360|NCT01234675|183014699|SUPERIORITY||Paired difference|-1.03||||0.685|TWO_SIDED|95.0|-8.2|5.6|||Paired T test|||||5.6|-8.2|0.685
91563361|NCT01234675|183014700|SUPERIORITY||Paired difference|-5.3||||0.349|TWO_SIDED|95.0|-17.0|6.4|||Paired T test|||||6.4|-17.0|0.349
91563362|NCT01234675|183014701|SUPERIORITY||Paired difference|-0.6||||0.305|TWO_SIDED|95.0|-1.8|5.6|||Paired T test|||||5.6|-1.8|0.305
91563363|NCT01234675|183014702|SUPERIORITY||Paired difference|-0.5||||0.425|TWO_SIDED|95.0|-1.8|0.8|||Paired T test|||||0.8|-1.8|0.425
91769426|NCT01506271|183425758|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|1.4|||<|0.001|TWO_SIDED|95.0|-5.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.6|-5.2|< 0.001
91563364|NCT01838499|183014708|SUPERIORITY_OR_OTHER||Difference in proportions|0.051|||>|0.05|TWO_SIDED|80.0|-0.067|0.169|||Mixed Models Analysis||MEDI8968 - placebo|Analysis of proportion of Responders for Physician's Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.169|-0.067|>0.05
91563365|NCT01838499|183014709|SUPERIORITY_OR_OTHER||Difference in proportions|-0.065|||>|0.05|TWO_SIDED|80.0|-0.205|0.076|||Mixed Models Analysis|||Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.076|-0.205|>0.05
91769427|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Blood, lymphatic||5.1|-7.3|
91769428|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.3|0.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Blood, lymphatic||0.1|-10.3|
91769429|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-5.2|5.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Cardiac disorder||5.0|-5.2|
91769430|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Cardiac disorder||6.3|-4.5|
91563366|NCT01838499|183014710|SUPERIORITY_OR_OTHER||Change from baseline (at week 12)|-0.03||||0.945|TWO_SIDED|80.0|-0.63|0.57|||ANCOVA||MEDI8968 - Placebo|Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate||0.57|-0.63|0.945
91563367|NCT03614923|183014711|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints would be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|Least Squares (LS) Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.319||0.2364|TWO_SIDED|95.0|-1.01|0.25||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.25|-1.01|0.2364
91563368|NCT03614923|183014711|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.316||0.2024|TWO_SIDED|95.0|-1.03|0.22||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.22|-1.03|0.2024
91563369|NCT03614923|183014712|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|4.383||0.133|TWO_SIDED|95.0|-15.34|2.06||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||2.06|-15.34|0.1330
91563370|NCT03614923|183014712|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|4.375||0.6464|TWO_SIDED|95.0|-10.7|6.67||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||6.67|-10.70|0.6464
91563371|NCT01136733|183014716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0005|TWO_SIDED|95.0|0.24|0.68|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.||0.68|0.24|=0.0005
91563372|NCT01136733|183014716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0479|TWO_SIDED|95.0|0.38|0.98|||Log Rank|||||0.98|0.38|0.0479
91563373|NCT01136733|183014716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.1209|TWO_SIDED|95.0|0.39|1.1|||Log Rank|||||1.10|0.39|0.1209
91563374|NCT01136733|183014717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.514|||=|0.0242|TWO_SIDED|95.0|0.299|0.884|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.||0.884|0.299|=0.0242
91769431|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.6|||||TWO_SIDED|95.0|-3.9|15.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - GI disorders||15.3|-3.9|
91563375|NCT01136733|183014717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.684|||=|0.1181|TWO_SIDED|95.0|0.411|1.138|||Log Rank|||||1.138|0.411|=0.1181
91563376|NCT01136733|183014717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751|||=|0.3157|TWO_SIDED|95.0|0.433|1.301|||Log Rank|||||1.301|0.433|=0.3157
91563377|NCT01136733|183014718|SUPERIORITY_OR_OTHER||Rate ratio|7.2|||<|0.0001|TWO_SIDED|95.0|2.3|22.5||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact||Rate ratio was based on the normal approximation.|||22.5|2.3|<0.0001
91563378|NCT01136733|183014718|SUPERIORITY_OR_OTHER||Rate ratio|4.5||||0.0067|TWO_SIDED|95.0|1.4|14.7||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||14.7|1.4|0.0067
91563379|NCT01136733|183014718|SUPERIORITY_OR_OTHER||Rate ratio|1.6|||=|0.1007|TWO_SIDED|95.0|0.9|2.8||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||2.8|0.9|=0.1007
91769432|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-5.4|13.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - GI disorders||13.6|-5.4|
91769433|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.2|||||TWO_SIDED|95.0|-2.0|11.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Gen. dis \& admin.||11.0|-2.0|
91769434|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-4.2|7.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Gen. dis \& admin.||7.8|-4.2|
91563380|NCT01882088|183014731|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-06|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.000002
91563381|NCT01882088|183014732|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.2
91563382|NCT01882088|183014733|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.002415|||||||Wilcoxon (Mann-Whitney)|||||||0.002415
91563383|NCT01882088|183014734|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.000438|||||||Wilcoxon (Mann-Whitney)|||||||0.000438
91563384|NCT01882088|183014735|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
91563385|NCT01882088|183014736|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91769435|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-3.6|12.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Infect. \& Infest.||12.0|-3.6|
91769436|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Infect. \& Infest.||8.0|-6.5|
91769437|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Injury, poison.||5.1|-7.3|
91769438|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-5.0|8.5|||||Relebactam minus Placebo|Relebactam 1250mg - Placebo: Percentage Difference - Injury, poison.||8.5|-5.0|
91769439|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-9.8|7.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Investigations||7.4|-9.8|
91769440|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.9|||||TWO_SIDED|95.0|-10.5|6.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Investigations||6.5|-10.5|
91563386|NCT01882088|183014737|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91563387|NCT01882088|183014738|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
91563388|NCT01882088|183014739|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
91563389|NCT01882088|183014740|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00002
91563390|NCT02186015|183014741|SUPERIORITY|A Wilcoxon signed rank test was performed.|||||<|0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in serum 25(OH)D from week 0 to week 8.||||<0.01
91563391|NCT02186015|183014742|SUPERIORITY|A Wilcoxon signed rank test was performed.||||||0.24|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in worst pain rating from week 0 to week 8.||||0.24
91563392|NCT02186015|183014743|SUPERIORITY|||||||0.09|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in fatigue score from week 0 to week 8.||||0.09
91563393|NCT02186015|183014744|SUPERIORITY|||||||0.17|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in mood score from week 0 to week 8.||||0.17
91769441|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
91563394|NCT02186015|183014745|SUPERIORITY|||||||0.5|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in dominant handgrip strength from week 0 to week 8.||||0.50
91563395|NCT02186015|183014746|SUPERIORITY|||||||0.16|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in sleep quality assessment from week 0 to week 8.||||0.16
91563396|NCT02186015|183014747|SUPERIORITY|||||||0.75|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-breast score from week 0 to week 8.||||0.75
91769442|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
91563397|NCT02186015|183014748|SUPERIORITY|||||||0.19|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-endocrine score from week 0 to week 8.||||0.19
91563398|NCT00125619|183014749|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.||||0.72
91563399|NCT00125619|183014749|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Robot (Lokomat) training.||||<.05
91769443|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Psychiatric disorders||5.4|-5.7|
91769444|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Psychiatric disorders||5.5|-5.7|
91563400|NCT00125619|183014749|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.||||>.05
91563401|NCT00125619|183014750|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of Robot vs. Manual training.||||>0.05
91563402|NCT00125619|183014750|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.||||>.05
91563403|NCT00125619|183014750|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.||||<.05
91563404|NCT00125619|183014751|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of robot vs. manual training.||||>.05
91563405|NCT00125619|183014751|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects for manual training.||||>.05
91563406|NCT00125619|183014751|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon signed ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||>.05
91563407|NCT00125619|183014752|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of effects of robot vs. manual training.||||>.05
91563408|NCT00125619|183014752|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison of pre- vs. post-treatment effects of manual training.||||>.05
91563409|NCT00125619|183014752|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of robot training.||||<.05
91563410|NCT00125619|183014753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
91563411|NCT00125619|183014753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within groups comparison for pre- vs. post-training effects of manual training.||||>.05
91769445|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
91563412|NCT00125619|183014753|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within group comparison for pre- vs. post-training effects of robot training.||||>.05
91563413|NCT00125619|183014754|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
91563414|NCT00125619|183014754|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||>.05
91563415|NCT00125619|183014754|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
91563416|NCT00125619|183014755|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
91563417|NCT00125619|183014755|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||<.05
91563418|NCT00125619|183014755|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
91563419|NCT01533181|183014756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.9||||0.0001|TWO_SIDED|95.0|1.9|8.1|||Kaplan-Meier|||||8.1|1.9|0.0001
91563420|NCT01533181|183014759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.71|TWO_SIDED|95.0|0.6|2.2|||Kaplan-Meier|||||2.2|0.6|0.71
91563421|NCT02720198|183014761|SUPERIORITY||Mean Difference (Final Values)|1.159|STANDARD_ERROR_OF_MEAN|1.834||0.53|TWO_SIDED|95.0|-2.518|4.836|||t-test, 2 sided|||||4.836|-2.518|0.53
91563422|NCT02720198|183014762|SUPERIORITY||Odds Ratio (OR)|0.492|STANDARD_ERROR_OF_MEAN|0.806||0.428|TWO_SIDED|95.0|0.101|2.388|||Mantel Haenszel|||||2.388|0.101|0.428
91563423|NCT02720198|183014763|SUPERIORITY||Odds Ratio (OR)|0.451|STANDARD_ERROR_OF_MEAN|0.724||0.272|TWO_SIDED|95.0|0.109|1.866|||Mantel Haenszel|||||1.866|0.109|0.272
91563424|NCT02720198|183014764|SUPERIORITY||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|1.428||0.664|TWO_SIDED|95.0|-3.484|2.236|||t-test, 2 sided|||||2.236|-3.484|0.664
91563425|NCT02720198|183014765|SUPERIORITY||Mean Difference (Final Values)|2.34|STANDARD_ERROR_OF_MEAN|2.199||0.292|TWO_SIDED|95.0|-2.07|6.75|||t-test, 2 sided|||||6.750|-2.070|0.292
91563426|NCT02720198|183014766|SUPERIORITY||Odds Ratio (OR)|1.063|STANDARD_ERROR_OF_MEAN|0.525||0.884|TWO_SIDED|95.0|0.38|2.971|||Mantel Haenszel|||||2.971|0.380|0.884
91563427|NCT02720198|183014767|SUPERIORITY||Odds Ratio (OR)|0.875|STANDARD_ERROR_OF_MEAN|0.65||0.905|TWO_SIDED|95.0|0.245|3.129|||Mantel Haenszel|||||3.129|0.245|0.905
91563428|NCT02720198|183014768|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.423||0.254|TWO_SIDED|95.0|-1.211|4.492|||t-test, 2 sided|||||4.492|-1.211|0.254
91563429|NCT02720198|183014769|SUPERIORITY||Mean Difference (Final Values)|-3.693|STANDARD_ERROR_OF_MEAN|1.91||0.058|TWO_SIDED|95.0|-7.52|0.134|||t-test, 2 sided|||||0.134|-7.520|0.058
91563430|NCT02720198|183014770|SUPERIORITY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|2.158||0.913|TWO_SIDED|95.0|-4.559|4.088|||t-test, 2 sided|||||4.088|-4.559|0.913
91563431|NCT02720198|183014771|SUPERIORITY||Mean Difference (Final Values)|-0.459|STANDARD_ERROR_OF_MEAN|1.035||0.66|TWO_SIDED|95.0|-2.54|1.623|||t-test, 2 sided|||||1.623|-2.540|0.660
91563432|NCT03897075|183014772|SUPERIORITY|||||||0.00311|||||||Cochran-Mantel-Haenszel|||||||0.00311
91563433|NCT03897075|183014773|SUPERIORITY|||||||0.00079|||||||Cochran-Mantel-Haenszel|||||||0.00079
91563434|NCT03897075|183014774|SUPERIORITY|||||||0.09892|||||||Cochran-Mantel-Haenszel|||||||0.09892
91563435|NCT00385697|183014797|SUPERIORITY||Odds Ratio (OR)|0.963||||0.904|TWO_SIDED|95.0|0.521|1.779|||Mantel Haenszel|||||1.779|0.521|0.904
91563436|NCT00385697|183014797|SUPERIORITY||Odds Ratio (OR)|0.629||||0.222|TWO_SIDED|95.0|0.297|1.33|||Mantel Haenszel|||||1.330|0.297|0.222
91563437|NCT00385697|183014797|SUPERIORITY||Odds Ratio (OR)|1.054||||0.885|TWO_SIDED|95.0|0.521|2.129|||Mantel Haenszel|||||2.129|0.521|0.885
91563438|NCT00385697|183014799|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.814|TWO_SIDED|95.0|-0.45|0.572|||ANCOVA|||||0.572|-0.450|0.814
91563439|NCT00385697|183014799|SUPERIORITY||Mean Difference (Final Values)|0.161||||0.593|TWO_SIDED|95.0|-0.433|0.755|||ANCOVA|||||0.755|-0.433|0.593
91563440|NCT00385697|183014799|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-0.594|0.513|||ANCOVA|||||0.513|-0.594|0.886
91563441|NCT00385697|183014801|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.049|TWO_SIDED|95.0|0.0|0.093|||ANCOVA|||||0.093|0.000|0.049
91563442|NCT00385697|183014801|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.937|TWO_SIDED|95.0|-0.061|0.056|||ANCOVA|||||0.056|-0.061|0.937
91563443|NCT00385697|183014801|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.382|TWO_SIDED|95.0|-0.032|0.084|||ANCOVA|||||0.084|-0.032|0.382
91563444|NCT00385697|183014803|SUPERIORITY||Odds Ratio (OR)|0.881||||0.775|TWO_SIDED|95.0|0.372|2.089|||Mantel Haenszel|||||2.089|0.372|0.775
91563445|NCT00385697|183014803|SUPERIORITY||Odds Ratio (OR)|0.628||||0.402|TWO_SIDED|95.0|0.212|1.861|||Mantel Haenszel|||||1.861|0.212|0.402
91563446|NCT00385697|183014803|SUPERIORITY||Odds Ratio (OR)|1.093||||0.859|TWO_SIDED|95.0|0.41|2.912|||Mantel Haenszel|||||2.912|0.410|0.859
91563447|NCT00385697|183014805|SUPERIORITY||Odds Ratio (OR)|1.265||||0.404|TWO_SIDED|95.0|0.727|2.2|||Mantel Haenszel|||||2.200|0.727|0.404
91563448|NCT00385697|183014805|SUPERIORITY||Odds Ratio (OR)|0.805||||0.528|TWO_SIDED|95.0|0.412|1.576|||Mantel Haenszel|||||1.576|0.412|0.528
91563449|NCT00385697|183014805|SUPERIORITY||Odds Ratio (OR)|1.133||||0.706|TWO_SIDED|95.0|0.594|2.164|||Mantel Haenszel|||||2.164|0.594|0.706
91563450|NCT00385697|183014807|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.872|TWO_SIDED|95.0|-0.455|0.536|||ANCOVA|||||0.536|-0.455|0.872
91563451|NCT00385697|183014807|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.979|TWO_SIDED|95.0|-0.581|0.556|||ANCOVA|||||0.556|-0.581|0.979
91563452|NCT00385697|183014807|SUPERIORITY||Mean Difference (Final Values)|-0.225||||0.4|TWO_SIDED|95.0|-0.75|0.301|||ANCOVA|||||0.301|-0.750|0.400
91563453|NCT02790788|183014835|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|4.3||0.44|TWO_SIDED|95.0|-5.2|11.8|||t-test, 2 sided|||Independent Samples t-test||11.8|-5.2|0.44
91563454|NCT02790788|183014837|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.6||0.17|TWO_SIDED|95.0|-2.2|12.2|||t-test, 2 sided|||||12.2|-2.2|0.17
91563455|NCT02790788|183014838|SUPERIORITY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.0||0.043|TWO_SIDED|95.0|0.4|20.8|||t-test, 2 sided|||||20.8|0.4|0.043
91563456|NCT02790788|183014839|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.7||0.59|TWO_SIDED|95.0|-9.3|5.3|||t-test, 2 sided|||||5.3|-9.3|0.59
91563457|NCT02790788|183014840|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.0||0.64|TWO_SIDED|95.0|-3.1|5.0|||t-test, 2 sided|||||5.0|-3.1|0.64
91563458|NCT02790788|183014841|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|3.0||0.2|TWO_SIDED|95.0|-10.1|2.1|||t-test, 2 sided|||||2.1|-10.1|0.20
91563459|NCT02790788|183014842|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.14|TWO_SIDED|95.0|-0.9|6.6|||t-test, 2 sided|||||6.6|-0.9|0.14
91563460|NCT02790788|183014843|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.4||0.9|TWO_SIDED|95.0|-6.4|7.3|||t-test, 2 sided|||||7.3|-6.4|0.90
91769446|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
91563461|NCT02790788|183014844|SUPERIORITY||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.2||0.33|TWO_SIDED|95.0|-2.2|6.4|||t-test, 2 sided|||||6.4|-2.2|0.33
91563462|NCT02790788|183014845|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|2.8||0.92|TWO_SIDED|95.0|-5.3|5.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA WITHIN 12 HOURS AFTER ROSC||5.8|-5.3|0.92
91563463|NCT02790788|183014845|SUPERIORITY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED|95.0|-3.4|1.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA WITHIN 12 HOURS AFTER ROSC||1.8|-3.4|0.54
91563464|NCT02790788|183014845|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_ERROR_OF_MEAN|2.17||0.048|TWO_SIDED|95.0|0.04|9.15|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA AT 72 HOURS AFTER ROSC||9.15|0.04|0.048
91563465|NCT02790788|183014845|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.4||0.18|TWO_SIDED|95.0|-1.0|4.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA AT 72 HOURS AFTER ROSC||4.7|-1.0|0.18
91563466|NCT02790788|183014846|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|3.6||0.32|TWO_SIDED|95.0|-10.9|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF WITHIN 12 HOURS AFTER ROSC||3.7|-10.9|0.32
91563467|NCT02790788|183014846|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.1||0.76|TWO_SIDED|95.0|-7.2|5.3|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 12 HOURS AFTER ROSC||5.3|-7.2|0.76
91769447|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.7|0.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Resp. \& chest||0.7|-10.7|
91563468|NCT02790788|183014846|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|4.2||0.25|TWO_SIDED|95.0|-13.5|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF AT 72 HOURS AFTER ROSC||3.7|-13.5|0.25
91563469|NCT02790788|183014846|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|3.5||0.61|TWO_SIDED|95.0|-9.1|5.5|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 72 HOURS AFTER ROSC||5.5|-9.1|0.61
91563470|NCT02790788|183014847|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.25|0.11|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI WITHIN 12 HOURS OF ROSC.||0.11|-0.25|0.41
91563471|NCT02790788|183014847|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED|95.0|-0.26|0.1|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI WITHIN 12 HOURS AFTER ROSC.||0.10|-0.26|0.38
91563472|NCT02790788|183014847|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.46|TWO_SIDED|95.0|-0.29|0.14|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.14|-0.29|0.46
91563473|NCT02790788|183014847|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.33|0.12|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.12|-0.33|0.34
91563474|NCT02790788|183014848|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.65||0.9|TWO_SIDED|95.0|-1.5|1.3|||t-test, 2 sided|||||1.3|-1.5|0.90
91563475|NCT02790788|183014849|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.37||0.59|TWO_SIDED|95.0|-0.54|0.94|||t-test, 2 sided|||||0.94|-0.54|0.59
91563476|NCT02790788|183014850|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.38||0.67|TWO_SIDED|95.0|-0.6|0.93|||t-test, 2 sided|||||0.93|-0.60|0.67
91563477|NCT02790788|183014851|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.65|TWO_SIDED|95.0|-0.64|1.02|||t-test, 2 sided|||||1.02|-0.64|0.65
91563478|NCT02790788|183014852|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.41|TWO_SIDED|95.0|-1.2|2.8||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 0-6 HOURS AFTER ROSC.|t-test, 2 sided|||||2.8|-1.2|0.41
91563479|NCT02790788|183014852|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|95.0|-0.92|0.19|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.19|-0.92|0.20
91563480|NCT02790788|183014852|SUPERIORITY||Median Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-1.0|0.04|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.04|-1.00|0.07
91563481|NCT02790788|183014852|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.29||0.36|TWO_SIDED|95.0|-0.85|0.31|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 18-24 HOURS AFTER ROSC.||0.31|-0.85|0.36
91769448|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-8.4|4.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Resp. \& chest||4.4|-8.4|
91769449|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-2.4|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Skin \& subcutan.||8.1|-2.4|
91769450|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.7|4.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Skin \& subcutan.||4.5|-4.7|
91563482|NCT02790788|183014852|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.25||0.54|TWO_SIDED|95.0|-0.66|0.35|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 24-30 HOURS AFTER ROSC.||0.35|-0.66|0.54
91563483|NCT02790788|183014852|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|95.0|-0.69|0.42|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 30-36 HOURS AFTER ROSC.||0.42|-0.69|0.62
91563484|NCT02790788|183014852|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.71|0.41|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 36-42 HOURS AFTER ROSC.||0.41|-0.71|0.60
91563485|NCT02790788|183014852|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.69|0.36|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 42-48 HOURS AFTER ROSC.||0.36|-0.69|0.54
91563486|NCT02790788|183014853|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.87||0.42|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||1.1|-2.5|0.42
91563487|NCT02790788|183014853|SUPERIORITY||Median Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|0.79||0.4|TWO_SIDED|95.0|-0.94|2.3|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 96.0 MMHG||2.30|-0.94|0.40
91563488|NCT02790788|183014853|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.15||0.44|TWO_SIDED|95.0|-1.49|3.28|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||3.28|-1.49|0.44
91769451|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-9.9|2.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vascular disorders||2.0|-9.9|
91769452|NCT01506271|183425760|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-6.9|6.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vascular disorders||6.6|-6.9|
91769453|NCT00539994|183425780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91563489|NCT02790788|183014853|SUPERIORITY||Median Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|1.23||0.36|TWO_SIDED|95.0|-1.4|3.7|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 97.0 MMHG||3.70|-1.40|0.36
91563490|NCT02790788|183014854|SUPERIORITY|||||||0.84|||||||Mann Whitney|||||||0.84
91563491|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.144||0.86|TWO_SIDED|95.0|-0.311|0.262|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 4 HOURS AFTER ROSC||0.262|-0.311|0.86
91563492|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.111||0.56|TWO_SIDED|95.0|-0.287|0.158|||t-test, 2 sided|||RESULTS CORRESPOND TO TNF-α AT 4 HOURS AFTER ROSC||0.158|-0.287|0.56
91769454|NCT00539994|183425780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
91563493|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.034|STANDARD_ERROR_OF_MEAN|0.053||0.52|TWO_SIDED|95.0|-0.071|0.139|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 4 HOURS AFTER ROSC||0.139|-0.071|0.52
91563494|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.107||0.7|TWO_SIDED|95.0|-0.254|0.172|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 4 HOURS AFTER ROSC||0.172|-0.254|0.70
91563495|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.167||0.97|TWO_SIDED|95.0|-0.326|0.34|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 4 HOURS AFTER ROSC||0.340|-0.326|0.97
91563496|NCT02790788|183014855|SUPERIORITY||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.129||0.61|TWO_SIDED|95.0|-0.192|0.326|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 24 HOURS AFTER ROSC||0.326|-0.192|0.61
91563497|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.126||0.91|TWO_SIDED|95.0|-0.238|0.267|||t-test, 2 sided|||RESULTS CORRESPOND TO TNFα AT 24 HOURS AFTER ROSC||0.267|-0.238|0.91
91563498|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.19|TWO_SIDED|95.0|-0.1|0.021|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 24 HOURS AFTER ROSC||0.021|-0.100|0.19
91563499|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.111||0.85|TWO_SIDED|95.0|-0.244|0.201|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 24 HOURS AFTER ROSC||0.201|-0.244|0.85
91563500|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.162||0.37|TWO_SIDED|95.0|-0.179|0.473|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 24 HOURS AFTER ROSC||0.473|-0.179|0.37
91563501|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.127||0.74|TWO_SIDED|95.0|-0.298|0.212|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 48 HOURS AFTER ROSC||0.212|-0.298|0.74
91563502|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.246|0.318|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 48 HOURS AFTER ROSC||0.318|-0.246|0.80
91563503|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.056|STANDARD_ERROR_OF_MEAN|0.043||0.2|TWO_SIDED|95.0|-0.03|0.142|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 48 HOURS AFTER ROSC||0.142|-0.030|0.20
91769455|NCT01928927|183425823|SUPERIORITY||Theta statistic|0.5||||0.97|TWO_SIDED|95.0|0.26|0.73||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.73|0.26|0.97
91769456|NCT01928927|183425824|SUPERIORITY||Theta statistic|0.57||||0.61|TWO_SIDED|95.0|0.31|0.83||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.83|0.31|0.61
91769457|NCT01604291|183425891|OTHER|||||||0.9109||||||The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|Chi-squared|||Correlation between SVR 24 and Gender||||0.9109
91769458|NCT01604291|183425891|OTHER|||||||0.1163||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Age||||0.1163
91769459|NCT01604291|183425891|OTHER|||||||0.9269||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Height||||0.9269
91769460|NCT01604291|183425891|OTHER|||||||0.3376||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Weight||||0.3376
91563504|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.111||0.83|TWO_SIDED|95.0|-0.246|0.198|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 48 HOURS AFTER ROSC||0.198|-0.246|0.83
91563505|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.124||0.83|TWO_SIDED|95.0|-0.223|0.276|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 48 HOURS AFTER ROSC||0.276|-0.223|0.83
91563506|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.161||0.85|TWO_SIDED|95.0|-0.294|0.354|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 72 HOURS AFTER ROSC||0.354|-0.294|0.85
91563507|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.048|STANDARD_ERROR_OF_MEAN|0.145||0.74|TWO_SIDED|95.0|-0.243|0.339|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 72 HOURS AFTER ROSC||0.339|-0.243|0.74
91563508|NCT02790788|183014855|SUPERIORITY||Median Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.039||0.75|TWO_SIDED|95.0|-0.066|0.091|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 72 HOURS AFTER ROSC||0.091|-0.066|0.75
91563509|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.096||0.64|TWO_SIDED|95.0|-0.238|0.149|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 72 HOURS AFTER ROSC||0.149|-0.238|0.64
91769461|NCT01604291|183425891|OTHER|||||||0.4618||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Body mass index.||||0.4618
91563510|NCT02790788|183014855|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.147||0.23|TWO_SIDED|95.0|-0.116|0.475|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 72 HOURS AFTER ROSC||0.475|-0.116|0.23
91563511|NCT02790788|183014856|SUPERIORITY||Percent Difference|4.9||||0.45|TWO_SIDED|95.0|-4.8|14.6|||Fisher Exact|||||14.6|-4.8|0.45
91769462|NCT01604291|183425904|OTHER||phi-coefficient|-0.0835||||0.0463|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables|Correlation with dose modification for Peginterferon alfa-2a.||||0.0463
91563512|NCT02790788|183014857|SUPERIORITY||Mann-Whitney U|50903.5||||0.68|TWO_SIDED||||||Mann Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERGLYCEMIA||||0.68
91563513|NCT02790788|183014857|SUPERIORITY||Mann Whitney U|52188.5||||0.68|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERNATREMIA||||0.68
91563514|NCT02790788|183014857|SUPERIORITY||Mann-Whitney U|1128.5||||0.37|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF INFECTION||||0.37
91563515|NCT01721109|183014866|EQUIVALENCE|A sample size of 14 participants was estimated to provide over 95% power to show pharmacokinetic equivalence between adult and adolescent participants. EVG population PK from historical adult data was used for comparison. The inter-subject standard deviation (natural log scale) of EVG AUCtau observed in the population PK data was 0.31 (historical data).|Geometric least squares mean ratio|1.3029|||||TWO_SIDED|90.0|1.0479|1.62||||||||1.6200|1.0479|
91563516|NCT00134056|183014877|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.64|TWO_SIDED|95.0|0.9|1.19|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.19|0.90|0.64
91563517|NCT00134056|183014878|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.81|TWO_SIDED|95.0|0.89|1.16|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.16|0.89|0.81
91563518|NCT02267746|183014908|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.93|||||TWO_SIDED|90.0|0.86|1.02|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.02|0.86|
91563519|NCT02267746|183014909|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.96|||||TWO_SIDED|90.0|0.89|1.04|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.04|0.89|
91769463|NCT01604291|183425904|OTHER||phi-coefficient|0.0666||||0.2052|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Ribavirin.||||0.2052
91769464|NCT01604291|183425904|OTHER||phi-coefficient|-0.1672||||0.0033|||||||Fisher Exact|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Telaprevir/boceprevir.||||0.0033
91769465|NCT02775916|183425926|SUPERIORITY||Mean Difference (Net)|-0.69|STANDARD_DEVIATION|1.332|||TWO_SIDED|95.0|-3.343|1.937||||||||1.937|-3.343|
91563520|NCT02267746|183014910|EQUIVALENCE|Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for PP population.|Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.15|0.004|||||Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for the PP population.|Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.||0.004|-0.150|
91563521|NCT00348283|183014918|SUPERIORITY_OR_OTHER|||||||0.056||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|Because of the hierarchical testing scheme used for testing the ranked secondary endpoints, alpha level of 0.05 was used at each stage of testing.||ITT population: all subjects randomized at Week 4 who had at least 1 dose of blinded therapy. The sample-size (placebo = 65 subjects; adalimumab = 65 subjects) for the primary efficacy analysis was calculated using 88% power at 0.05 alpha level based on the assumption that 25% and 5% of subjects were without mucosal ulceration at Week 12 in adalimumab 40 mg eow and placebo groups, respectively. However, subjects without mucosal ulceration at Screening were excluded from the primary analysis.||||0.056
91563522|NCT00348283|183014919|SUPERIORITY_OR_OTHER|||||||0.021||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||0.021
91563523|NCT00348283|183014920|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at Week 52 in the two treatment groups.||||<0.001
91563524|NCT00348283|183014921|SUPERIORITY_OR_OTHER|||||||0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 52 in the two treatment groups.||||0.001
91563525|NCT00348283|183014922|SUPERIORITY_OR_OTHER|||||||0.15||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at both Week 12 and Week 52 in the two treatment groups.||||0.150
91563526|NCT00348283|183014923|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||<0.001
91563527|NCT05878522|183014953|OTHER||LS Mean difference|11.73|||||TWO_SIDED|90.0|8.89|14.58||||||3- hours post-dose||14.58|8.89|
91563528|NCT05878522|183014953|OTHER||LS Mean difference|11.35|||||TWO_SIDED|90.0|8.5|14.2||||||4-hours post-dose||14.20|8.50|
91563529|NCT05878522|183014953|OTHER||LS Mean difference|8.35||||||90.0|5.51|11.2||||||5-hours post-dose||11.20|5.51|
91563530|NCT02009865|183015010|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-14.2||||0.017|TWO_SIDED|95.0|-26.2|-2.8|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-26.2|0.017
91563531|NCT02009865|183015011|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.3||||0.0008|TWO_SIDED|95.0|-40.5|-11.5|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Main analysis with missing values imputed using probabilities of missing estimated from logistic regression||-11.5|-40.5|0.0008
91563532|NCT02009865|183015012|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.0||||0.018|TWO_SIDED|95.0|-14.8|-2.8||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-14.8|0.0180
91563533|NCT02009865|183015013|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.3||||0.7117|TWO_SIDED|95.0|-3.5|4.9||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||4.9|-3.5|0.7117
91563534|NCT02009865|183015014|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.3||||0.3034|TWO_SIDED|95.0|-23.9|3.5||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||3.5|-23.9|0.3034
91563535|NCT01178281|183015053|OTHER|||||||1|||||||Fisher Exact|||||||1.000
91563536|NCT01178281|183015055|OTHER|||||||0.929|||||||Log Rank|||||||0.929
91769466|NCT02775916|183425927|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-2.52|3.55||||||||3.55|-2.52|
91563537|NCT03722485|183015063|SUPERIORITY|||||||0.292||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Regression, Linear|Test of treatment effect using a generalized linear model with treatment arm, baseline values, and clinical site as factors.||||||0.2920
91563538|NCT03722485|183015064|SUPERIORITY|||||||0.0213||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.0213
91563539|NCT03722485|183015065|SUPERIORITY|||||||0.7422||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.7422
91563540|NCT03722485|183015066|SUPERIORITY|||||||0.6322|||||||Fisher Exact|||||||0.6322
91769467|NCT02775916|183425928|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.119|||TWO_SIDED|95.0|-6.08|6.89||||||||6.89|-6.08|
91769468|NCT02775916|183425928|SUPERIORITY||Mean Difference (Net)|4.33|STANDARD_ERROR_OF_MEAN|4.615|||TWO_SIDED|95.0|-5.27|13.93||||||||13.93|-5.27|
91563541|NCT01636258|183015143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.1||0.72|TWO_SIDED|95.0|-1.4|2.0||P-value less than 0.05 considered statistically significant a priori. No multiple comparison adjustment made.|t-test, 2 sided|||No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||2.0|-1.4|0.72
91563542|NCT01636258|183015144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||||0.31
91563543|NCT01636258|183015145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
91563544|NCT01636258|183015146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91563545|NCT03034772|183015168|SUPERIORITY|||||||0.04|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.04
91563546|NCT03034772|183015169|SUPERIORITY|||||||0.11|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.11
91563547|NCT03034772|183015170|SUPERIORITY|||||||0.01|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.01
91563548|NCT03034772|183015171|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.78
91563549|NCT03034772|183015172|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.24
91563550|NCT00116584|183015173|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
91563551|NCT00116584|183015174|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91563552|NCT00116584|183015175|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91563553|NCT04879823|183015242|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||Null hypothesis: Average pain scores before medication will not be lower in the dexamethasone group compared with the placebo group.||||0.03
91563554|NCT04879823|183015243|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care (at least 1 time) post-operatively between dexamethasone and placebo groups.||||0.07
91563555|NCT04879823|183015244|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: Average pain scores after medication will not be lower in the dexamethasone group compared with the placebo group.||||0.98
91563556|NCT02137239|183015263|SUPERIORITY||Incidence of Change|-1.7|||||TWO_SIDED|95.0|-18.9|16.7||||||Change in Incidence of Treatment A as compared to Treatment B at 6 Months||16.7|-18.9|
91563557|NCT02137239|183015263|SUPERIORITY||Incidence of Change|-1.0|||||TWO_SIDED|95.0|-19.2|18.9||||||Change in Incidence of Treatment A as compared to Treatment B at 12 Months||18.9|-19.2|
91563558|NCT02137239|183015263|SUPERIORITY||Incidence of Change|2.9|||||TWO_SIDED|95.0|-16.1|23.9||||||Change in Incidence of Treatment A as compared to Treatment B at 24 Months||23.9|-16.1|
91563559|NCT04057937|183015290|SUPERIORITY||Percentage Difference:Apremilast-Placebo|37.4||||0.0003|TWO_SIDED|95.0|18.6|56.1||Two-sided 0.10 significant level|Chi-squared||Confidence Intervals calculated using the Wald method (normal approximation).|||56.1|18.6|0.0003
91563560|NCT01072396|183015341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0087||95.0|0.02|0.11||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - crossover design||0.11|0.02|0.0087
91563561|NCT01072396|183015342|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.0685||||0.067||95.0|0.9953|1.147||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||1.1470|0.9953|0.0670
91563562|NCT01072396|183015343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2059||||0.2417||95.0|-0.5527|0.1408||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||0.1408|-0.5527|0.2417
91563563|NCT02446912|183015344|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-4.2||||0.412|TWO_SIDED|95.0|-14.2|5.8||Nominal p-value|Cochran-Mantel-Haenszel|||||5.8|-14.2|0.412
91563564|NCT02446912|183015344|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-14.7|9.6||||||||9.6|-14.7|
91563565|NCT02446912|183015345|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.9||||0.455|TWO_SIDED|95.0|-6.3|14.1||Nominal p-value|Cochran-Mantel-Haenszel|||||14.1|-6.3|0.455
91563566|NCT02446912|183015345|SUPERIORITY||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-6.7|17.8||||||||17.8|-6.7|
91563567|NCT02446912|183015346|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-3.4||||0.549|TWO_SIDED|95.0|-14.4|7.6||Nominal p-value|Cochran-Mantel-Haenszel|||||7.6|-14.4|0.549
91769469|NCT02775916|183425929|SUPERIORITY||Mean Difference (Net)|-6.55|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|-21.76|8.66||||||||8.66|-21.76|
91769470|NCT02775916|183425930|SUPERIORITY||Mean Difference (Net)|-10.97|STANDARD_ERROR_OF_MEAN|9.626|||TWO_SIDED|95.0|-30.94|9.0||||||||9.00|-30.94|
91769471|NCT02775916|183425931|SUPERIORITY||Mean Difference (Net)|-7.69|STANDARD_ERROR_OF_MEAN|10.595|||TWO_SIDED|95.0|-29.75|14.37||||||||14.37|-29.75|
91563568|NCT02446912|183015347|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|6.4||||0.261|TWO_SIDED|95.0|-4.8|17.7||Nominal p-value|Cochran-Mantel-Haenszel|||||17.7|-4.8|0.261
91563569|NCT02446912|183015348|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|8.9||||0.18|TWO_SIDED|95.0|-4.1|21.9||Nominal p-value|Cochran-Mantel-Haenszel|||||21.9|-4.1|0.180
91563570|NCT02446912|183015349|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.7||||0.013|TWO_SIDED|95.0|3.5|29.8||Nominal p-value|Cochran-Mantel-Haenszel|||||29.8|3.5|0.013
91563571|NCT02446912|183015350|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|17.0||||0.054|TWO_SIDED|95.0|-0.3|34.3||Nominal p-value|Cochran-Mantel-Haenszel|||||34.3|-0.3|0.054
91563572|NCT02446912|183015351|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|18.7||||0.034|TWO_SIDED|95.0|1.4|36.0||Nominal p-value|Cochran-Mantel-Haenszel|||||36.0|1.4|0.034
91563573|NCT02446912|183015352|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|0.6||||0.905|TWO_SIDED|95.0|-9.4|10.6||Nominal p-value|Cochran-Mantel-Haenszel|||||10.6|-9.4|0.905
91563574|NCT02446912|183015353|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.3||||0.515|TWO_SIDED|95.0|-6.7|13.4||Nominal p-value|Cochran-Mantel-Haenszel|||||13.4|-6.7|0.515
91563575|NCT02446912|183015354|SUPERIORITY|Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.|Rate Ratio|0.83||||0.258|TWO_SIDED|95.0|0.6|1.14||Nominal p-value|Negative binomial regression|||||1.14|0.60|0.258
91563576|NCT02446912|183015355|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|0.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|0.6|
91563577|NCT02446912|183015356|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.4|||||TWO_SIDED|95.0|6.7|26.2|||Cochran-Mantel-Haenszel|||||26.2|6.7|
91563578|NCT01106586|183015372|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.0|||||TWO_SIDED|95.2|-1.9|7.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.||7.8|-1.9|
91563579|NCT04864236|183015388|EQUIVALENCE|We compared particle number counts between intervention and control groups using the Wilcoxon test. Analyses were conducted using IBM SPSS V28 and p-values \<0.05 were considered statistically significant.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91563580|NCT04864236|183015389|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.073|||||||t-test, 1 sided|||||||0.073
91563581|NCT04864236|183015390|EQUIVALENCE|Patient characteristics and study variables were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.67|||||||t-test, 1 sided|||||||0.670
91563582|NCT04864236|183015391|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.167|||||||t-test, 1 sided|||||||0.167
91563583|NCT04864236|183015392|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.198|||||||t-test, 1 sided|||||||0.198
91563584|NCT04864236|183015393|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.442|||||||t-test, 1 sided|||||||0.442
91563585|NCT02991456|183015396|OTHER|||||||0.2734|||||||Chi-squared|||||||0.2734
91563586|NCT02991456|183015397|OTHER|||||||0.7091|||||||Chi-squared|||||||0.7091
91563587|NCT02991456|183015398|EQUIVALENCE|This was tested as patients who preferred rolapitant + ondansetron vs. patients who did not prefer rolapitant + ondansetron. Patients who reported no preference and preference to Ondansetron were combined.||||||0.0004|||||||Exact Binomial|||||||0.0004
91563588|NCT02991456|183015398|EQUIVALENCE|Three outcomes tested by sequence.||||||0.5207|||||||Fisher Exact|||||||0.5207
91563589|NCT02991456|183015399|EQUIVALENCE|Effectiveness during weeks 1-3 between sequences.||||||0.0406|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.0406
91563590|NCT02991456|183015400|EQUIVALENCE|Convenience during weeks 1-3 between sequences.||||||0.0541|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0541
91563591|NCT02991456|183015401|EQUIVALENCE|Overall satisfaction during weeks 1-3 between sequences.||||||0.0781|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0781
91563592|NCT02991456|183015402|EQUIVALENCE|Effectiveness during weeks 4-6 between sequences.||||||0.4146|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.4146
91563593|NCT02991456|183015403|EQUIVALENCE|Convenience during weeks 4-6 between sequences.||||||0.2214|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.2214
91563594|NCT02991456|183015404|EQUIVALENCE|Overall satisfaction during weeks 4-6 between sequences.||||||0.2028|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.2028
91563595|NCT00936065|183015429|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Fisher Exact|||Overall treatment difference||||0.0672
91563596|NCT00936065|183015430|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 2||||1.0000
91563597|NCT00936065|183015430|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 4||||0.0229
91563598|NCT00936065|183015430|SUPERIORITY_OR_OTHER|||||||0.0256|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 8||||0.0256
91563599|NCT00936065|183015430|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 12||||0.0004
91563600|NCT00936065|183015430|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 18||||0.0105
91563601|NCT00936065|183015430|SUPERIORITY_OR_OTHER|||||||0.0366|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 24||||0.0366
91563602|NCT00936065|183015431|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||1.0000
91563603|NCT00936065|183015431|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.3230
91563604|NCT00936065|183015431|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||1.0000
91563605|NCT00936065|183015431|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||1.0000
91563606|NCT00936065|183015432|SUPERIORITY_OR_OTHER|||||||0.3103|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.3103
91563607|NCT00936065|183015432|SUPERIORITY_OR_OTHER|||||||0.4763|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.4763
91563608|NCT00936065|183015432|SUPERIORITY_OR_OTHER|||||||0.1961|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1961
91563609|NCT00936065|183015432|SUPERIORITY_OR_OTHER|||||||0.0272|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0272
91563610|NCT00936065|183015432|SUPERIORITY_OR_OTHER|||||||0.5038|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.5038
91563611|NCT00936065|183015432|SUPERIORITY_OR_OTHER|||||||0.0374|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0374
91563612|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.6061|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.6061
91563613|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.2971|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.2971
91563614|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.1119|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.1119
91563615|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.1081|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1081
91563616|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0063
91563617|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.0055|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0055
91563618|NCT00936065|183015433|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0031
91563619|NCT00936065|183015434|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0033
91563620|NCT00936065|183015435|SUPERIORITY_OR_OTHER|||||||0.0448|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0448
91563621|NCT00936065|183015436|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0041
91563622|NCT00936065|183015437|SUPERIORITY_OR_OTHER|||||||0.3536|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.3536
91563623|NCT00936065|183015438|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0203
91563624|NCT00936065|183015438|SUPERIORITY_OR_OTHER|||||||0.0102|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0102
91563625|NCT00936065|183015438|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0056
91563626|NCT00936065|183015438|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0006
91563627|NCT00936065|183015438|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0066
91563628|NCT00936065|183015438|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0058
91563629|NCT00936065|183015439|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0329
91563630|NCT00936065|183015439|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0003
91563631|NCT00936065|183015439|SUPERIORITY_OR_OTHER|||||||0.0598|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0598
91563632|NCT00936065|183015439|SUPERIORITY_OR_OTHER|||||||0.0241|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0241
91563633|NCT00936065|183015439|SUPERIORITY_OR_OTHER|||||||0.0543|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0543
91563634|NCT00936065|183015439|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.1205
91563635|NCT00936065|183015440|SUPERIORITY_OR_OTHER|||||||0.1385|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1385
91563636|NCT00936065|183015440|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0019
91563637|NCT00936065|183015440|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0442
91563638|NCT00936065|183015440|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0034
91563639|NCT00936065|183015440|SUPERIORITY_OR_OTHER|||||||0.0454|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0454
91563640|NCT00936065|183015440|SUPERIORITY_OR_OTHER|||||||0.0539|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0539
91563641|NCT00936065|183015441|SUPERIORITY_OR_OTHER|||||||0.1723|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1723
91563642|NCT00936065|183015441|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0292
91563643|NCT00936065|183015441|SUPERIORITY_OR_OTHER|||||||0.0908|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0908
91563644|NCT00936065|183015441|SUPERIORITY_OR_OTHER|||||||0.5678|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.5678
91563645|NCT00936065|183015441|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.4820
91563646|NCT00936065|183015441|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0394
91563647|NCT00936065|183015442|SUPERIORITY_OR_OTHER|||||||0.1079|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1079
91563648|NCT00936065|183015442|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0004
91563649|NCT00936065|183015442|SUPERIORITY_OR_OTHER|||||||0.0146|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0146
91563650|NCT00936065|183015442|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0019
91563651|NCT00936065|183015442|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0062
91563652|NCT00936065|183015442|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0197
91563653|NCT00936065|183015443|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1229
91563654|NCT00936065|183015443|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0136
91563655|NCT00936065|183015443|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.1578
91563656|NCT00936065|183015443|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0565
91563657|NCT00936065|183015443|SUPERIORITY_OR_OTHER|||||||0.0685|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0685
91563658|NCT00936065|183015443|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0493
91563659|NCT00936065|183015444|SUPERIORITY_OR_OTHER|||||||0.3112|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3112
91563660|NCT00936065|183015444|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0196
91563661|NCT00936065|183015444|SUPERIORITY_OR_OTHER|||||||0.0109|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0109
91563662|NCT00936065|183015444|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0035
91563663|NCT00936065|183015444|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0603
91563664|NCT00936065|183015444|SUPERIORITY_OR_OTHER|||||||0.2184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2184
91563665|NCT00936065|183015445|SUPERIORITY_OR_OTHER|||||||0.1774|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1774
91563666|NCT00936065|183015445|SUPERIORITY_OR_OTHER|||||||0.1195|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1195
91563667|NCT00936065|183015445|SUPERIORITY_OR_OTHER|||||||0.0606|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0606
91563668|NCT00936065|183015445|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0030
91563669|NCT00936065|183015445|SUPERIORITY_OR_OTHER|||||||0.1567|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1567
91563670|NCT00936065|183015445|SUPERIORITY_OR_OTHER|||||||0.2094|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2094
91563671|NCT00936065|183015446|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0302
91563672|NCT00936065|183015446|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0980
91563673|NCT00936065|183015446|SUPERIORITY_OR_OTHER|||||||0.0711|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0711
91563674|NCT00936065|183015446|SUPERIORITY_OR_OTHER|||||||0.0077|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0077
91563675|NCT00936065|183015446|SUPERIORITY_OR_OTHER|||||||0.1553|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1553
91563676|NCT00936065|183015446|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
91563677|NCT00936065|183015447|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0060
91563678|NCT00936065|183015447|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0058
91563679|NCT00936065|183015447|SUPERIORITY_OR_OTHER|||||||0.0127|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0127
91563680|NCT00936065|183015447|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0068
91563681|NCT00936065|183015447|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0096
91563682|NCT00936065|183015447|SUPERIORITY_OR_OTHER|||||||0.0132|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0132
91563683|NCT00936065|183015448|SUPERIORITY_OR_OTHER|||||||0.6904|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.6904
91563684|NCT00936065|183015448|SUPERIORITY_OR_OTHER|||||||0.7021|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.7021
91563685|NCT00936065|183015448|SUPERIORITY_OR_OTHER|||||||0.2199|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2199
91563686|NCT00936065|183015448|SUPERIORITY_OR_OTHER|||||||0.5071|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5071
91563687|NCT00936065|183015448|SUPERIORITY_OR_OTHER|||||||0.4765|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4765
91563688|NCT00936065|183015448|SUPERIORITY_OR_OTHER|||||||0.8662|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.8662
91563689|NCT00936065|183015449|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1144
91563690|NCT00936065|183015449|SUPERIORITY_OR_OTHER|||||||0.4509|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4509
91563691|NCT00936065|183015449|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4350
91563692|NCT00936065|183015449|SUPERIORITY_OR_OTHER|||||||0.6085|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6085
91563693|NCT00936065|183015449|SUPERIORITY_OR_OTHER|||||||0.2582|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2582
91563694|NCT00936065|183015449|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.5490
91563695|NCT00936065|183015450|SUPERIORITY_OR_OTHER|||||||0.3287|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3287
91563696|NCT00936065|183015450|SUPERIORITY_OR_OTHER|||||||0.4149|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4149
91563697|NCT00936065|183015450|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.3837
91563698|NCT00936065|183015450|SUPERIORITY_OR_OTHER|||||||0.6777|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6777
91563699|NCT00936065|183015450|SUPERIORITY_OR_OTHER|||||||0.4976|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4976
91563700|NCT00936065|183015450|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.4189
91563701|NCT00936065|183015451|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4760
91563702|NCT00936065|183015451|SUPERIORITY_OR_OTHER|||||||0.404|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4040
91563703|NCT00936065|183015451|SUPERIORITY_OR_OTHER|||||||0.4753|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4753
91563704|NCT00936065|183015451|SUPERIORITY_OR_OTHER|||||||0.5084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5084
91563705|NCT00936065|183015451|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2293
91563706|NCT00936065|183015451|SUPERIORITY_OR_OTHER|||||||0.3822|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3822
91563707|NCT00936065|183015452|SUPERIORITY_OR_OTHER|||||||0.2691|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.2691
91563708|NCT00936065|183015452|SUPERIORITY_OR_OTHER|||||||0.0142|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0142
91563709|NCT00936065|183015452|SUPERIORITY_OR_OTHER|||||||0.0383|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0383
91563710|NCT00936065|183015452|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0026
91563711|NCT00936065|183015452|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0475
91563712|NCT00936065|183015452|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0205
91563713|NCT00936065|183015453|SUPERIORITY_OR_OTHER|||||||0.0512|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0512
91563714|NCT00936065|183015453|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0024
91563715|NCT00936065|183015453|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0946
91563716|NCT00936065|183015453|SUPERIORITY_OR_OTHER|||||||0.0935|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0935
91563717|NCT00936065|183015453|SUPERIORITY_OR_OTHER|||||||0.2073|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2073
91563718|NCT00936065|183015453|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
91563719|NCT00936065|183015454|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0202
91563720|NCT00936065|183015454|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0090
91563721|NCT00936065|183015454|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0742
91563722|NCT00936065|183015454|SUPERIORITY_OR_OTHER|||||||0.0445|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0445
91563723|NCT00936065|183015454|SUPERIORITY_OR_OTHER|||||||0.2211|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2211
91563724|NCT00936065|183015454|SUPERIORITY_OR_OTHER|||||||0.1982|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.1982
91563725|NCT00936065|183015455|SUPERIORITY_OR_OTHER|||||||0.0409|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0409
91563726|NCT00936065|183015455|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1450
91563727|NCT00936065|183015455|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2010
91563728|NCT00936065|183015455|SUPERIORITY_OR_OTHER|||||||0.0424|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0424
91563729|NCT00936065|183015455|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0090
91563730|NCT00936065|183015455|SUPERIORITY_OR_OTHER|||||||0.0116|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0116
91563731|NCT00936065|183015456|SUPERIORITY_OR_OTHER|||||||0.3355|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3355
91563732|NCT00936065|183015456|SUPERIORITY_OR_OTHER|||||||0.0341|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0341
91563733|NCT00936065|183015456|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0899
91563734|NCT00936065|183015456|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0062
91563735|NCT00936065|183015456|SUPERIORITY_OR_OTHER|||||||0.1241|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1241
91563736|NCT00936065|183015456|SUPERIORITY_OR_OTHER|||||||0.0393|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0393
91563737|NCT00936065|183015457|SUPERIORITY_OR_OTHER|||||||0.3402|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3402
91563738|NCT00936065|183015457|SUPERIORITY_OR_OTHER|||||||0.1184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1184
91563739|NCT00936065|183015457|SUPERIORITY_OR_OTHER|||||||0.0104|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0104
91563740|NCT00936065|183015457|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0010
91563741|NCT00936065|183015457|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0250
91563742|NCT00936065|183015457|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
91563743|NCT00936065|183015458|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0894
91563744|NCT00936065|183015458|SUPERIORITY_OR_OTHER|||||||0.0084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0084
91563745|NCT00936065|183015458|SUPERIORITY_OR_OTHER|||||||0.0727|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0727
91563746|NCT00936065|183015458|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0337
91563747|NCT00936065|183015458|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1380
91563748|NCT00936065|183015458|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
91563749|NCT00936065|183015459|SUPERIORITY_OR_OTHER|||||||0.4407|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4407
91563750|NCT00936065|183015459|SUPERIORITY_OR_OTHER|||||||0.1768|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1768
91563751|NCT00936065|183015459|SUPERIORITY_OR_OTHER|||||||0.4636|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4636
91563752|NCT00936065|183015459|SUPERIORITY_OR_OTHER|||||||0.334|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.3340
91563753|NCT00936065|183015459|SUPERIORITY_OR_OTHER|||||||0.1785|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1785
91563754|NCT00936065|183015459|SUPERIORITY_OR_OTHER|||||||0.7428|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.7428
91563755|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.5377
91563756|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.1419|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.1419
91563757|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.5391|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.5391
91563758|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.2589
91563759|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0635
91563760|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.1172|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.1172
91563761|NCT00936065|183015460|SUPERIORITY_OR_OTHER|||||||0.1247|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.1247
91563762|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.9429|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.9429
91563763|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.0927
91563764|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.0151
91563765|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.1124|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1124
91563766|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.0242|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0242
91563767|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0237
91563768|NCT00936065|183015461|SUPERIORITY_OR_OTHER|||||||0.0176|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0176
91563769|NCT00738400|183015489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|||<|0.0001||95.0|-9.03|-4.49|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-4.49|-9.03|<0.0001
91563770|NCT00738400|183015490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|||<|0.0001||95.0|-30.66|-10.76|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-10.76|-30.66|<0.0001
91563771|NCT00738400|183015491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|||<|0.0001||95.0|-37.48|-14.83|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-14.83|-37.48|<0.0001
91563772|NCT00738400|183015492|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mantel Haenszel|||Mantel-Haenszel Test||||0.0004
91563773|NCT00738400|183015493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.57||||0.0003||95.0|-23.8|-7.34|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-7.34|-23.80|0.0003
91563774|NCT00738400|183015494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.33|||<|0.0001||95.0|-37.24|-17.43|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-17.43|-37.24|<0.0001
91563775|NCT02255474|183015496|SUPERIORITY||Mean Difference (Final Values)|-1.01|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons, treatment group p-value|Mixed Models Analysis|||Both eyes used in analysis adjusting for correlation.||||<0.01
91563776|NCT02255474|183015497|SUPERIORITY||quadratic coefficient|0.02||||0.05|TWO_SIDED||||||Mixed Models Analysis|||Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.||||0.05
91563777|NCT02255474|183015498|SUPERIORITY||regression coefficient|-0.12||||0.05|TWO_SIDED||||||Regression, Linear|Models control for age, sex, axial length at baseline, race, treatment group, treatment group by race interaction.||This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in place||||0.05
91563778|NCT02255474|183015499|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.05|TWO_SIDED|||||Adjusted for multiple comparisons|Mixed Models Analysis|||Both eyes used in the analysis controlling for the correlation.||||0.05
91563779|NCT01082159|183015511|SUPERIORITY_OR_OTHER||change from baseline|3.59|STANDARD_DEVIATION|2.87|<|0.0001|TWO_SIDED|95.0|2.76|4.42|||t-test, 2 sided|||||4.42|2.76|<0.0001
91563780|NCT01082159|183015512|SUPERIORITY_OR_OTHER||Change from Baseline|12.17|STANDARD_DEVIATION|19.14|<|0.0001|TWO_SIDED|95.0|6.64|17.71|||t-test, 2 sided|||||17.71|6.64|<0.0001
91563781|NCT01542502|183015514|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
91563782|NCT01542502|183015515|SUPERIORITY_OR_OTHER|||||||0.87|||||||ANOVA|||||||0.87
91563783|NCT01154699|183015554|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||The difference in the change in asthma control during the Usual care and the Bilevel PAP period were compared.||||0.8
91563784|NCT01154699|183015555|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change in PC20 between the two arms||||0.20
91563785|NCT01154699|183015556|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
91563786|NCT01154699|183015557|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
91563787|NCT01154699|183015558|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
91563788|NCT01154699|183015559|SUPERIORITY_OR_OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
91563789|NCT01755598|183015560|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, is to be above 0%.|Vaccine efficacy rate|49.7||||0.043|TWO_SIDED|90.0|12.1|71.2|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, as compared to placebo.||71.2|12.1|0.0430
91563790|NCT01755598|183015561|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. If the primary objective is met, this secondary objective is to be analysed using the following success criterion: The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV infection, meeting the case definition 2, is to be above 0%.|Vaccine efficacy rate|61.67||||0.021|TWO_SIDED|90.0|24.084|80.647|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite Xpert MTB/Rif positive pulmonary TB disease not associated with HIV-infection, meeting the case definition 2, as compared to placebo.||80.647|24.084|0.0210
91563791|NCT02819141|183015599|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< 0.05.|Generalized estimating equations|Controlling for age, daily sequential organ failure assessment (SOFA) score, sedation intensity, and time of day of assessment||We estimated the power for multilevel models approximating our study design. A sample size of 95 patients per arm, 190 total (at a minimum 7 data collection points for each, resulting in \~1,050 observations) will have greater than 80% power to detect small to moderate effects (i.e., 0.11 or greater) in between-group differences in anxiety, delirium, and duration of mechanical ventilation at alpha = .05 for all proposed models.||||0.30
91563792|NCT02819141|183015599|SUPERIORITY|Controlling for time of day, study day, age, sex, illness severity, and sedation frequency||||||0.9858|||||||Generalized Estimating equations|||||||0.9858
91563793|NCT02819141|183015600|SUPERIORITY|||||||0.02||||||a priori threshold for significance p \< 0.05.|t-test, 1 sided|||||||0.02
91563794|NCT02819141|183015601|SUPERIORITY|||||||0.97|||||||Generalized estimating equations|Controlling for sedation intensity, age, daily Sequential Organ Failure Assessment (SOFA) score, study day, and time of day assessment||||||0.97
91563795|NCT02819141|183015601|SUPERIORITY|||||||0.5647|||||||Generalized estimating equations|Controlling for sedation frequency, age, sex, illness severity, study day, and time of day assessment.||||||0.5647
91563796|NCT02819141|183015602|SUPERIORITY|||||||0.39|||||||Generalized estimating equation|controlling for age, daily Sequential Organ Failure Assessment (SOFA) score, time of day of assessment||||||0.39
91563797|NCT02819141|183015603|SUPERIORITY|||||||0.37|||||||GEE|||||||0.37
91563798|NCT02819141|183015604|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
91563799|NCT02819141|183015604|SUPERIORITY|||||||0.81|||||||t-test, 1 sided|||||||0.81
91563800|NCT02819141|183015605|SUPERIORITY|||||||0.47|||||||t-test, 1 sided|||||||0.47
91563801|NCT02819141|183015605|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
91563802|NCT02819141|183015606|SUPERIORITY|||||||0.164|||||||t-test, 1 sided|||3 months after ICU discharge||||0.164
91563803|NCT02819141|183015606|SUPERIORITY|||||||0.84|||||||t-test, 1 sided|||6 months after ICU discharge||||0.84
91563804|NCT02819141|183015607|SUPERIORITY|||||||0.26|||||||t-test, 1 sided|||||||0.26
91563805|NCT02819141|183015608|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
91563806|NCT02819141|183015609|SUPERIORITY|||||||0.018|||||||t-test, 1 sided|||||||0.018
91563807|NCT02819141|183015610|SUPERIORITY|||||||0.66|||||||t-test, 1 sided|||||||0.66
91563808|NCT02819141|183015611|SUPERIORITY|||||||0.63|||||||t-test, 1 sided|||||||0.63
91563809|NCT02819141|183015612|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||||||0.41
91563810|NCT02819141|183015613|SUPERIORITY|||||||0.06|||||||t-test, 1 sided|||||||0.06
91563811|NCT02819141|183015614|SUPERIORITY|||||||0.93|||||||t-test, 1 sided|||||||0.93
91563812|NCT02819141|183015615|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.43
91563813|NCT02819141|183015616|SUPERIORITY|||||||0.69|||||||t-test, 1 sided|||||||0.69
91563814|NCT02819141|183015617|SUPERIORITY|||||||0.94|||||||t-test, 1 sided|||||||0.94
91563815|NCT02819141|183015618|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|||||||0.50
91563816|NCT02819141|183015619|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
91563817|NCT02819141|183015620|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
91563818|NCT02819141|183015621|SUPERIORITY|||||||0.85|||||||t-test, 1 sided|||||||0.85
91563819|NCT02819141|183015622|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
91563820|NCT01184859|183015658|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.211
91563821|NCT01184859|183015658|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.010
91563822|NCT01184859|183015658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
91563823|NCT01184859|183015658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
91563824|NCT01184859|183015659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.272||||0.194|TWO_SIDED|95.0|-0.685|-0.141||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.141|-0.685|0.194
91563825|NCT01184859|183015659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.547||||0.015|TWO_SIDED|95.0|-0.985|-0.108||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.108|-0.985|0.015
91563826|NCT01184859|183015659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||<|0.001|TWO_SIDED|95.0|-1.317|-0.391||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.391|-1.317|<0.001
91563827|NCT01184859|183015659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.888||||0.001|TWO_SIDED|95.0|-1.426|-0.351||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.351|-1.426|0.001
91563828|NCT01537120|183015748|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.85|0.96||||||||0.96|0.85|
91563829|NCT01537120|183015749|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|||||TWO_SIDED|90.0|-0.36|-0.23||||||||-0.23|-0.36|
91563830|NCT01537120|183015750|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46|||||TWO_SIDED|90.0|-0.62|-0.3||||||||-0.30|-0.62|
91563831|NCT00644332|183015799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in angina frequency from Baseline to Week 4||||
91563832|NCT00644332|183015800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in NTG use from Baseline to Week 4||||
91563833|NCT00644332|183015801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|0.8||||||||||||||||
91563834|NCT00409006|183015806|SUPERIORITY_OR_OTHER|||||||0.0618||95.0|||||Log Rank|||||||0.0618
91563835|NCT00409006|183015807|SUPERIORITY_OR_OTHER|||||||0.369||95.0|||||Regression, Logistic|Used the Wald Chi-squared statistic from a logistic regression analysis.||||||0.369
91563836|NCT03050372|183015811|EQUIVALENCE|Significance level alpha=0.05; CI=95%.||||||0.329|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ"||||0.329
91563837|NCT03050372|183015811|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.321|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.321
91563838|NCT03050372|183015811|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.687|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.687
91563839|NCT03050372|183015812|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.925|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ"||||0.925
91563840|NCT03050372|183015812|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.08|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.08
91563841|NCT03050372|183015812|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.221|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.221
91563842|NCT03050372|183015813|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.197|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ"||||0.197
91563843|NCT03050372|183015813|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.586|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.586
91563844|NCT03050372|183015813|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.298|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.298
91563845|NCT03050372|183015814|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.424|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ"||||0.424
91563846|NCT03050372|183015814|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.21|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.210
91563847|NCT03050372|183015814|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.19|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.190
91563848|NCT03050372|183015815|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.535|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ"||||0.535
91563849|NCT03050372|183015815|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.196|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.196
91563850|NCT03050372|183015815|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.092|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.092
91563851|NCT03050372|183015816|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||1|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ"||||1.00
91563852|NCT03050372|183015816|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.004|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.004
91563853|NCT03050372|183015816|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.042|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.042
91563854|NCT03050372|183015817|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.05|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ"||||0.05
91563855|NCT03050372|183015817|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.379|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.379
91563856|NCT03050372|183015817|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.284|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.284
91563857|NCT03050372|183015818|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.226|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ"||||0.226
91563858|NCT03050372|183015818|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.156|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.156
91563859|NCT03050372|183015818|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.117|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.117
91563860|NCT03050372|183015819|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.13|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ"||||0.130
91563861|NCT03050372|183015819|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.249|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.249
91563862|NCT03050372|183015819|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.114|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.114
91563863|NCT00443755|183015823|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91563864|NCT00443755|183015824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91563865|NCT00443755|183015825|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
91563866|NCT00443755|183015826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91563867|NCT00443755|183015827|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in triglyceride levels.||||0.03
91563868|NCT00443755|183015827|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in HDL-C levels.||||0.06
91563869|NCT00443755|183015827|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of mean change in non-HDL-C levels.||||0.06
91563870|NCT00443755|183015828|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
91563871|NCT00443755|183015829|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91563872|NCT00443755|183015830|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.13
91563873|NCT00443755|183015831|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
91563874|NCT00443755|183015832|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
91563875|NCT00443755|183015833|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
91563876|NCT00443755|183015834|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.006
91563877|NCT00443755|183015835|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
91563878|NCT00443755|183015836|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
91563879|NCT02706834|183015839|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.43|||||TWO_SIDED|90.0|0.38|0.487|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.||0.487|0.380|
91563880|NCT02706834|183015846|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.896|||||TWO_SIDED|90.0|0.833|0.964|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.||0.964|0.833|
91563881|NCT05065918|183015897|SUPERIORITY||Slope|-0.536||||0.448|TWO_SIDED|95.0|-1.929|0.857|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.857|-1.929|0.448
91563882|NCT05065918|183015898|SUPERIORITY||Slope|0.99||||0.969|TWO_SIDED|95.0|-1.152|1.108|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.108|-1.152|0.969
91563883|NCT05065918|183015899|SUPERIORITY||Slope|-0.5||||0.231|TWO_SIDED|95.0|-1.322|0.322|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.322|-1.322|0.231
91563884|NCT05065918|183015900|SUPERIORITY||Slope|-0.319||||0.398|TWO_SIDED|95.0|-1.064|0.425|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.425|-1.064|0.398
91563885|NCT05065918|183015901|SUPERIORITY||Slope|0.284||||0.382|TWO_SIDED|95.0|-0.356|0.924|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.924|-.356|0.382
91563886|NCT05065918|183015902|SUPERIORITY||Slope|0.382||||0.266|TWO_SIDED|95.0|-0.284|1.025|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.025|-.284|0.266
91563887|NCT05065918|183015903|SUPERIORITY||Slope|0.53||||0.019|TWO_SIDED|95.0|0.089|0.97|||Regression, Linear|||||.970|0.089|0.019
91563888|NCT05065918|183015904|SUPERIORITY||Slope|0.277||||0.284|TWO_SIDED|95.0|-0.232|0.787|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.787|-.232|0.284
91563889|NCT05065918|183015905|SUPERIORITY||Slope|0.709||||0.076|TWO_SIDED|95.0|-0.076|1.494|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.494|-.076|0.076
91563890|NCT05065918|183015906|SUPERIORITY||Slope|0.625||||0.136|TWO_SIDED|95.0|-0.199|1.449|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.449|-.199|0.136
91563891|NCT03149887|183015907|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
91563892|NCT03149887|183015908|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
91563893|NCT03149887|183015909|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
91563894|NCT03149887|183015910|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
91563895|NCT03149887|183015911|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
91563896|NCT03149887|183015912|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
91563897|NCT03149887|183015913|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
91563898|NCT03149887|183015914|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
91563899|NCT03327051|183015919|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.||||||0.04|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||0.04
91563900|NCT03327051|183015919|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.|||||>|0.99|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||>0.99
91563901|NCT00724750|183015972|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.||||||0.6|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.|Mixed Models Analysis|||||||0.60
91563902|NCT00724750|183015973|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day.||||||0.19|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.|Mixed Models Analysis|||||||0.19
91563903|NCT00724750|183015975|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91563904|NCT00724750|183015976|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
91563905|NCT00724750|183015977|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91563906|NCT01014013|183015978|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint was based on the proportion of patients who had a favorable microbiological response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-0.8|STANDARD_DEVIATION|10.9||||95.0|-11.7|10.2||||||||10.2|-11.7|
91563907|NCT01014013|183015980|NON_INFERIORITY_OR_EQUIVALENCE|The secondary efficacy endpoint was based on the proportion of patients who had a favorable clinical response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-1.7|STANDARD_ERROR_OF_MEAN|4.9||||95.0|-6.6|3.2||||||||3.2|-6.6|
91563908|NCT05319756|183015981|SUPERIORITY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|ONE_SIDED|95.0|26.1||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||26.1|<.0001
91563909|NCT05319756|183015981|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|4.46||0.1041|ONE_SIDED|95.0||1.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||1.7||0.1041
91563910|NCT05319756|183015981|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|4.46||0.3373|ONE_SIDED|95.0||5.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||5.5||0.3373
91563911|NCT05319756|183015981|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|ONE_SIDED|95.0||-6.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-6.3||<.0001
91563912|NCT05319756|183015981|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|ONE_SIDED|95.0||-0.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-0.6||<0.0001
91563913|NCT05319756|183015981|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|4.0||0.0232|ONE_SIDED|95.0||9.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11"||9.6||0.0232
91563914|NCT05319756|183015981|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.01||0.2767|ONE_SIDED|95.0||15.2|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11."||15.2||0.2767
91563915|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|267.1|STANDARD_ERROR_OF_MEAN|83.688||0.0016|TWO_SIDED|90.0|128.8|405.4|||Mixed Models Analysis|||||405.4|128.8|0.0016
91563916|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|29.19|STANDARD_ERROR_OF_MEAN|83.688||0.7276|TWO_SIDED|90.0|-109.0|167.5|||Mixed Models Analysis|||||167.5|-109|0.7276
91563917|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|50.41|STANDARD_ERROR_OF_MEAN|83.785||0.5481|TWO_SIDED|90.0|-88.0|188.9|||Mixed Models Analysis|||||188.9|-88.0|0.5481
91563918|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|350.7|STANDARD_ERROR_OF_MEAN|84.023|<|0.0001|TWO_SIDED|90.0|211.8|489.5|||Mixed Models Analysis|||||489.5|211.8|<0.0001
91563919|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|364.4|STANDARD_ERROR_OF_MEAN|83.785|<|0.0001|TWO_SIDED|90.0|225.9|502.8|||Mixed Models Analysis|||||502.8|225.9|<0.0001
91563920|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|-238.0|STANDARD_ERROR_OF_MEAN|83.785||0.005|TWO_SIDED|90.0|-376.0|-99.4|||Mixed Models Analysis|||||-99.4|-376|0.0050
91563921|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|-217.0|STANDARD_ERROR_OF_MEAN|84.023||0.0106|TWO_SIDED|90.0|-356.0|-77.8|||Mixed Models Analysis|||||-77.8|-356|0.0106
91563922|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|83.6|STANDARD_ERROR_OF_MEAN|83.785||0.3196|TWO_SIDED|90.0|-54.9|222.1|||Mixed Models Analysis|||||222.1|-54.9|0.3196
91563923|NCT05319756|183015983|OTHER||Mean Difference (Final Values)|97.29|STANDARD_ERROR_OF_MEAN|83.688||0.2464|TWO_SIDED|90.0|-41.0|235.6|||Mixed Models Analysis|||||235.6|-41.0|0.2464
91563924|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|64.67|STANDARD_ERROR_OF_MEAN|7.581|<|0.0001|TWO_SIDED|90.0|52.15|77.2|||Mixed Models Analysis|||||77.20|52.15|<.0001
91563925|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|7.581||0.0546|TWO_SIDED|90.0|2.13|27.1|||Mixed Models Analysis|||||27.1|2.13|0.0546
91563926|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|11.58|STANDARD_ERROR_OF_MEAN|7.589||0.1286|TWO_SIDED|90.0|-0.96|24.12|||Mixed Models Analysis|||||24.12|-0.96|0.1286
91563927|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|68.99|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|56.42|81.57|||Mixed Models Analysis|||||81.57|56.42|<.0001
91563928|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|76.37|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|63.83|88.91|||Mixed Models Analysis|||||88.91|63.83|<.0001
91563929|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|-62.6|-37.5|||Mixed Models Analysis|||||-37.5|-62.6|<.0001
91563930|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|-65.7|-40.5|||Mixed Models Analysis|||||-40.5|-65.7|<.0001
91563931|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|7.589||0.5699|TWO_SIDED|90.0|-8.22|16.86|||Mixed Models Analysis|||||16.86|-8.22|0.5699
91563932|NCT05319756|183015989|OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|7.581||0.1243|TWO_SIDED|90.0|-0.83|24.23|||Mixed Models Analysis|||||24.23|-0.83|0.1243
91563933|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|286.7|STANDARD_ERROR_OF_MEAN|50.879|<|0.0001|TWO_SIDED|90.0|202.6|370.8|||Mixed Models Analysis|||||370.8|202.6|<.0001
91563934|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|53.85|STANDARD_ERROR_OF_MEAN|50.879||0.2912|TWO_SIDED|90.0|-30.2|137.9|||Mixed Models Analysis|||||137.9|-30.2|0.2912
91563935|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|97.8|STANDARD_ERROR_OF_MEAN|50.938||0.0563|TWO_SIDED|90.0|13.62|182.0|||Mixed Models Analysis|||||182.0|13.62|0.0563
91563936|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|484.5|STANDARD_ERROR_OF_MEAN|51.083|<|0.0001|TWO_SIDED|90.0|400.1|569.0|||Mixed Models Analysis|||||569.0|400.1|<.0001
91563937|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|396.6|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|312.4|480.8|||Mixed Models Analysis|||||480.8|312.4|<.0001
91563938|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|-233.0|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|-317.0|-149.0|||Mixed Models Analysis|||||-149|-317|<.0001
91563939|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|-189.0|STANDARD_ERROR_OF_MEAN|51.083||0.0003|TWO_SIDED|90.0|-273.0|-105.0|||Mixed Models Analysis|||||-105|-273|0.0003
91563940|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|197.8|STANDARD_ERROR_OF_MEAN|50.938||0.0001|TWO_SIDED|90.0|113.7|282.0|||Mixed Models Analysis|||||282.0|113.7|0.0001
91563941|NCT05319756|183015991|OTHER||Mean Difference (Final Values)|109.9|STANDARD_ERROR_OF_MEAN|50.879||0.032|TWO_SIDED|90.0|25.8|194.0|||Mixed Models Analysis|||||194.0|25.80|0.0320
91563942|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|18.73|STANDARD_ERROR_OF_MEAN|2.276|<|0.0001|TWO_SIDED|90.0|14.98|22.48|||Mixed Models Analysis|||||22.48|14.98|<0.0001
91563943|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.302||0.5056|TWO_SIDED|90.0|-2.03|5.56|||Mixed Models Analysis|||||5.56|-2.03|0.5056
91563944|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|4.62|STANDARD_ERROR_OF_MEAN|2.307||0.076|TWO_SIDED|90.0|0.82|8.42|||Mixed Models Analysis|||||8.42|0.82|0.0760
91563945|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|25.73|STANDARD_ERROR_OF_MEAN|2.315|<|0.0001|TWO_SIDED|90.0|21.92|29.54|||Mixed Models Analysis|||||29.54|21.92|<0.0001
91563946|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|24.42|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|90.0|20.68|28.16|||Mixed Models Analysis|||||28.16|20.68|<0.0001
91563947|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|-17.0|STANDARD_ERROR_OF_MEAN|2.297|<|0.0001|TWO_SIDED|90.0|-20.8|-13.2|||Mixed Models Analysis|||||-13.2|-20.8|<0.0001
91563948|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|90.0|-17.9|-10.3|||Mixed Models Analysis|||||-10.3|-17.9|<0.0001
91563949|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.298||0.0024|TWO_SIDED|90.0|3.22|10.79|||Mixed Models Analysis|||||10.79|3.22|0.0024
91563950|NCT05319756|183015992|OTHER||Mean Difference (Final Values)|5.69|STANDARD_ERROR_OF_MEAN|2.255||0.0118|TWO_SIDED|90.0|1.98|9.41|||Mixed Models Analysis|||||9.41|1.98|0.0118
91563951|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|20.31|STANDARD_ERROR_OF_MEAN|2.246|<|0.0001|TWO_SIDED|90.0|16.61|24.01|||Mixed Models Analysis|||||24.01|16.61|<0.0001
91563952|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|2.271||0.2439|TWO_SIDED|90.0|-1.09|6.39|||Mixed Models Analysis|||||6.39|-1.09|0.2439
91563953|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|2.276||0.0044|TWO_SIDED|90.0|2.75|10.25|||Mixed Models Analysis|||||10.25|2.75|0.0044
91563954|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|24.15|STANDARD_ERROR_OF_MEAN|2.284|<|0.0001|TWO_SIDED|90.0|20.39|27.91|||Mixed Models Analysis|||||27.91|20.39|<0.0001
91563955|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|28.19|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|24.5|31.88|||Mixed Models Analysis|||||31.88|24.50|<0.0001
91563956|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.266|<|0.0001|TWO_SIDED|90.0|-21.4|-13.9|||Mixed Models Analysis|||||-13.9|-21.4|<0.0001
91563957|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|2.268|<|0.0001|TWO_SIDED|90.0|-17.5|-10.1|||Mixed Models Analysis|||||-10.1|-17.5|<0.0001
91563958|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|2.267||0.0907|TWO_SIDED|90.0|0.11|7.57|||Mixed Models Analysis|||||7.57|0.11|0.0907
91563959|NCT05319756|183015993|OTHER||Mean Difference (Final Values)|7.88|STANDARD_ERROR_OF_MEAN|2.225||0.0004|TWO_SIDED|90.0|4.22|11.55|||Mixed Models Analysis|||||11.55|4.22|0.0004
91563960|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|25.37|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|90.0|22.86|27.88|||Mixed Models Analysis|||||27.88|22.86|<0.0001
91563961|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.529||0.0189|TWO_SIDED|90.0|1.08|6.11|||Mixed Models Analysis|||||6.11|1.08|0.0189
91563962|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|3.66|8.71|||Mixed Models Analysis|||||8.71|3.66|<0.0001
91563963|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|32.18|STANDARD_ERROR_OF_MEAN|1.537|<|0.0001|TWO_SIDED|90.0|29.65|34.71|||Mixed Models Analysis|||||34.71|29.65|<0.0001
91563964|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|30.17|STANDARD_ERROR_OF_MEAN|1.525|<|0.0001|TWO_SIDED|90.0|27.66|32.68|||Mixed Models Analysis|||||32.68|27.66|<0.0001
91563965|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.522|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<0.0001
91563966|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|90.0|-21.7|-16.7|||Mixed Models Analysis|||||-16.7|-21.7|<0.0001
91563967|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|6.81|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|4.3|9.31|||Mixed Models Analysis|||||9.31|4.30|<0.0001
91563968|NCT05319756|183015994|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.514||0.0015|TWO_SIDED|90.0|2.31|7.29|||Mixed Models Analysis|||||7.29|2.31|0.0015
91563969|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001|TWO_SIDED|90.0|3.01|5.45|||Mixed Models Analysis|||||5.45|3.01|<.0001
91563970|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.743||0.3933|TWO_SIDED|90.0|-0.59|1.86|||Mixed Models Analysis|||||1.86|-0.59|0.3933
91563971|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.747||0.2916|TWO_SIDED|90.0|-0.44|2.02|||Mixed Models Analysis|||||2.02|-0.44|0.2916
91563972|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|0.748|<|0.0001|TWO_SIDED|90.0|2.69|5.15|||Mixed Models Analysis|||||5.15|2.69|<.0001
91563973|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001|TWO_SIDED|90.0|2.0|4.44|||Mixed Models Analysis|||||4.44|2.00|<.0001
91563974|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|0.74|<|0.0001|TWO_SIDED|90.0|-4.81|-2.38|||Mixed Models Analysis|||||-2.38|-4.81|<.0001
91563975|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|90.0|-4.66|-2.22|||Mixed Models Analysis|||||-2.22|-4.66|<.0001
91563976|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.741||0.6765|TWO_SIDED|90.0|-1.53|0.91|||Mixed Models Analysis|||||0.91|-1.53|0.6765
91563977|NCT05319756|183015995|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.737||0.1712|TWO_SIDED|90.0|-2.22|0.2|||Mixed Models Analysis|||||0.20|-2.22|0.1712
91563978|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|1.526|<|0.0001|TWO_SIDED|90.0|22.19|27.21|||Mixed Models Analysis|||||27.21|22.19|<.0001
91563979|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|1.527||0.0606|TWO_SIDED|90.0|0.35|5.38|||Mixed Models Analysis|||||5.38|0.35|0.0606
91563980|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|1.534||0.0074|TWO_SIDED|90.0|1.59|6.64|||Mixed Models Analysis|||||6.64|1.59|0.0074
91563981|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|30.58|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|28.05|33.1|||Mixed Models Analysis|||||33.10|28.05|<.0001
91563982|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|29.99|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|27.48|32.5|||Mixed Models Analysis|||||32.50|27.48|<.0001
91563983|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.521|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<.0001
91563984|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|1.529|<|0.0001|TWO_SIDED|90.0|-23.1|-18.1|||Mixed Models Analysis|||||-18.1|-23.1|<.0001
91563985|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|1.523||0.0001|TWO_SIDED|90.0|3.37|8.38|||Mixed Models Analysis|||||8.38|3.37|0.0001
91563986|NCT05319756|183015996|OTHER||Mean Difference (Final Values)|5.29|STANDARD_ERROR_OF_MEAN|1.513||0.0005|TWO_SIDED|90.0|2.8|7.78|||Mixed Models Analysis|||||7.78|2.80|0.0005
91563987|NCT00442559|183016007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.015|TWO_SIDED|95.0|-0.29|-0.03|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.03|-0.29|0.015
91563988|NCT00442559|183016007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.027|TWO_SIDED|95.0|-0.3|-0.02|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.02|-0.3|0.027
91563989|NCT00442559|183016008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.006|TWO_SIDED|95.0|-0.36|-0.07|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.07|-0.36|0.006
91563990|NCT00442559|183016008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12||||0.032|TWO_SIDED|95.0|-0.24|-0.01|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.01|-0.24|0.032
91563991|NCT03906240|183016012|SUPERIORITY||Cohen's d|1.44|||<|0.001|TWO_SIDED|95.0|1.0|2.49|||t-test, 2 sided|t = 5.78||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||2.49|1.00|<.001
91563992|NCT03906240|183016012|SUPERIORITY||Cohen's d|0.78||||0.002|TWO_SIDED|95.0|0.35|1.38|||t-test, 2 sided|t = 3.48||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.38|0.35|.002
91563993|NCT03906240|183016013|SUPERIORITY||Cohen's d|0.01||||0.957|TWO_SIDED|95.0|-0.45|0.91|||t-test, 2 sided|t = 0.06||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.91|-0.45|.957
91563994|NCT03906240|183016013|SUPERIORITY||Cohen's d|0.51||||0.033|TWO_SIDED|95.0|0.08|1.25|||t-test, 2 sided|t = 2.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.25|0.08|.033
91563995|NCT03906240|183016014|SUPERIORITY||Cohen's d|0.71||||0.015|TWO_SIDED|95.0|0.32|1.31|||t-test, 2 sided|t = 2.76||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.31|0.32|.015
91563996|NCT03906240|183016014|SUPERIORITY||Cohen's d|0.74||||0.012|TWO_SIDED|95.0|0.26|1.55|||t-test, 2 sided|t = 2.87||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.55|0.26|.012
91563997|NCT03906240|183016014|SUPERIORITY||Cohen's d|0.02||||0.941|TWO_SIDED|95.0|-0.43|0.55|||t-test, 2 sided|t = 0.08||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.55|-0.43|.941
91563998|NCT03906240|183016014|SUPERIORITY||Cohen's d|0.25||||0.27|TWO_SIDED|95.0|-0.17|0.79|||t-test, 2 sided|t = 1.14||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.79|-0.17|.270
91563999|NCT03906240|183016015|SUPERIORITY||Cohen's d|0.08||||0.768|TWO_SIDED|95.0|-0.45|0.71|||t-test, 2 sided|t = 0.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.71|-0.45|.768
91564000|NCT03906240|183016015|SUPERIORITY||Cohen's d|0.01||||0.975|TWO_SIDED|95.0|-0.53|0.42|||t-test, 2 sided|t = 0.05||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.42|-0.53|.975
91564001|NCT03575572|183016021|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
91564002|NCT03575572|183016021|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91564003|NCT03575572|183016023|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91564004|NCT03575572|183016023|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
91564005|NCT03647709|183016028|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.9|1.2|||||Represents patients pain score post operative day 1 best with rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||1.2|0.9|
91564006|NCT03647709|183016028|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 1 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||2.6|2.2|
91564007|NCT03647709|183016028|OTHER||mean score|2.9|||||TWO_SIDED|95.0|2.7|3.1|||||Represents patients reported pain score post operative day 1 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.1|2.7|
91564008|NCT03647709|183016028|OTHER||mean score|4.6|||||TWO_SIDED|95.0|4.4|4.8|||||Represents patients reported pain score post operative day 1 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.8|4.4|
91564009|NCT03647709|183016028|OTHER||mean score|1.8|||||TWO_SIDED|95.0|1.6|2.0|||||Represents patients reported pain score post operative day 2 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.6|
91564010|NCT03647709|183016028|OTHER||mean score|3.4|||||TWO_SIDED|95.0|3.2|3.6|||||Represents patients reported pain score post operative day 2 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.6|3.2|
91564011|NCT03647709|183016028|OTHER||mean score|4.2|||||TWO_SIDED|95.0|4.0|4.4|||||Represents patients reported pain score post operative day 2 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.4|4.0|
91564012|NCT03647709|183016028|OTHER||mean score|5.9|||||TWO_SIDED|95.0|5.7|6.1|||||Represents patients reported pain score post operative day 2 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||6.1|5.7|
91564013|NCT03647709|183016028|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||Represents patients reported pain score post operative day 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.2|0.8|
91564014|NCT03647709|183016028|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.6|2.2|
91564015|NCT03647709|183016028|OTHER||mean score|3.3|||||TWO_SIDED|95.0|3.1|3.5|||||Represents patients reported pain score post operative day 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.5|3.1|
91564016|NCT03647709|183016028|OTHER||mean score|5.0|||||TWO_SIDED|95.0|4.8|5.2|||||Represents patients reported pain score post operative day 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||5.2|4.8|
91564017|NCT03647709|183016028|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative days 10-14 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
91564018|NCT03647709|183016028|OTHER||mean score|2.1|||||TWO_SIDED|95.0|1.9|2.3|||||Represents patients reported pain score post operative days 10-14 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.3|1.9|
91564019|NCT03647709|183016028|OTHER||mean score|2.0|||||TWO_SIDED|95.0|1.8|2.2|||||Represents patients reported pain score post operative days 10-14 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.2|1.8|
91564020|NCT03647709|183016028|OTHER||mean score|4.0|||||TWO_SIDED|95.0|3.8|4.2|||||Represents patients reported pain score post operative days 10-14 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.2|3.8|
91564021|NCT03647709|183016028|OTHER||mean score|0.3|||||TWO_SIDED|95.0|0.2|0.4|||||Represents patients reported pain score post operative week 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.4|0.2|
91564022|NCT03647709|183016028|OTHER||mean score|1.5|||||TWO_SIDED|95.0|1.3|1.7|||||Represents patients reported pain score post operative week 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.7|1.3|
91564023|NCT03647709|183016028|OTHER||mean score|1.3|||||TWO_SIDED|95.0|1.2|1.5|||||Represents patients reported pain score post operative week 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.5|1.2|
91564024|NCT03647709|183016028|OTHER||mean score|3.1|||||TWO_SIDED|95.0|2.9|3.3|||||Represents patients reported pain score post operative week 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.3|2.9|
91564025|NCT03647709|183016028|OTHER||mean score|0.1|||||TWO_SIDED|95.0|0.0|0.2|||||Represents patients reported pain score post operative week 6 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.0|
91564026|NCT03647709|183016028|OTHER||mean score|0.7|||||TWO_SIDED|95.0|0.5|0.8|||||Represents patients reported pain score post operative week 6 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.8|0.5|
91564027|NCT03647709|183016028|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||Represents patients reported pain score post operative week 6 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.6|0.4|
91564028|NCT03647709|183016028|OTHER||mean score|1.9|||||TWO_SIDED|95.0|1.7|2.0|||||Represents patients reported pain score post operative week 6 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.7|
91564029|NCT03647709|183016028|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Represents patients reported pain score post operative week 12 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.0|-0.0|
91564030|NCT03647709|183016028|OTHER||mean score|0.2|||||TWO_SIDED|95.0|0.1|0.2|||||Represents patients reported pain score post operative week 12 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.1|
91564031|NCT03647709|183016028|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.1|||||Represents patients reported pain score post operative week 12 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.1|-0.0|
91564032|NCT03647709|183016028|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative week 12 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
91564033|NCT03647709|183016031|OTHER|||||||0.0015|||||||Fisher Exact|||||||0.0015
91564034|NCT03647709|183016032|OTHER|||||||0.6398|||||||Fisher Exact|||||||.6398
91564035|NCT03647709|183016033|OTHER|||||||0.0658|||||||Fisher Exact|||||||.0658
91564036|NCT03647709|183016034|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91564037|NCT01426217|183016048|OTHER|Efficacy|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.63|0.98||||||||0.98|0.63|
91564038|NCT01426217|183016049|OTHER|Efficacy|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.62|1.35||||||||1.35|0.62|
91564039|NCT04799587|183016107|SUPERIORITY|Sample size for the study was determined by assuming a baseline rate of 33% of IONV and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD. A two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100. Statistical analyses were two-sided, and a P\<0.05 was required to reject the null hypothesis.||||||0.94|||||||Chi-squared|||The incidence of nausea and vomiting and the number of episodes between the P6 acupressure and sham acupressure groups were compared using a chi-square statistic (nominal data) or the Wilcoxon test (continuous data).||||.94
91564040|NCT04799587|183016108|SUPERIORITY|||||||0.95|||||||Chi-squared|||The sample size for the study was determined by assuming a baseline rate of 33% of intraoperative nausea and vomiting and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD.20 Using a two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100||||.95
91564041|NCT01075815|183016165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0235||||0.8762|TWO_SIDED|95.0|-0.1546|0.1568|||Wilcoxon two sample test|||||0.1568|-0.1546|0.8762
91564042|NCT01075815|183016166|SUPERIORITY_OR_OTHER|||||||0.3589||95.0|||||ANOVA|||||||0.3589
91564043|NCT01075815|183016167|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Wilcoxon two sample test|||||||0.0629
91564044|NCT01075815|183016168|SUPERIORITY_OR_OTHER|||||||0.4728||95.0|||||ANOVA|||||||0.4728
91564045|NCT01075815|183016169|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Fisher Exact|||||||0.0950
91564046|NCT01075815|183016171|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9625||||0.9179|TWO_SIDED|95.0|0.4655|1.99|||Chi-squared|||||1.9900|0.4655|0.9179
91564047|NCT01075815|183016172|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.875||||0.7271|TWO_SIDED|95.0|0.4133|1.8524|||Chi-squared|||||1.8524|0.4133|0.7271
91564048|NCT01075815|183016173|SUPERIORITY_OR_OTHER|||||||0.3267||95.0|||||Wilcoxon two sample test|||||||0.3267
91564049|NCT01075815|183016174|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||Wilcoxon two sample test|||||||0.4164
91564050|NCT01075815|183016175|SUPERIORITY_OR_OTHER|||||||0.5952||95.0|||||Wilcoxon two sample test|||||||0.5952
91564051|NCT01075815|183016177|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9444||||0.8852|TWO_SIDED|95.0|0.4347|2.0518|||Chi-squared|||||2.0518|0.4347|0.8852
91564052|NCT00763919|183016183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
91564053|NCT00763919|183016184|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.01
91564054|NCT00763919|183016185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
91564055|NCT00763919|183016186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<.001
91564056|NCT00763919|183016187|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
91564057|NCT00763919|183016188|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.042
91564058|NCT00763919|183016189|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.044
91564059|NCT00763919|183016190|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
91564060|NCT00763919|183016191|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.001
91564061|NCT00763919|183016192|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
91564062|NCT00763919|183016193|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
91564063|NCT00763919|183016194|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.827
91564064|NCT00763919|183016195|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
91564065|NCT00763919|183016196|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.246
91564066|NCT00763919|183016197|SUPERIORITY_OR_OTHER|||||||0.101||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.101
91564067|NCT00763919|183016198|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.003
91564068|NCT00763919|183016199|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.096
91564069|NCT00763919|183016200|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.072
91564070|NCT00763919|183016201|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
91564071|NCT00763919|183016202|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.078
91564072|NCT00763919|183016203|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.002
91564073|NCT00763919|183016204|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.562
91564074|NCT00763919|183016205|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.12
91564075|NCT00925288|183016206|NON_INFERIORITY_OR_EQUIVALENCE|Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.|||||>|0.2||95.0|||||Regression, Logistic|||The null hypothesis is that both schedules will provide an equivalent antibody response.||||>0.20
91564076|NCT00925288|183016207|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||Completion rates compared in the 2 study arms||||0.60
91564077|NCT00925288|183016208|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||comparison of differences in HPV DNA prevalence by study arm.||||0.53
91564078|NCT00635570|183016210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|Yates's chi-squared test with 1 degree of freedom was used for analysis||The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.||||0.05
91564079|NCT00635570|183016211|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|0.0|||||Chi-squared, Corrected|||||||>0.05
91564080|NCT00635570|183016212|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91564081|NCT00635570|183016213|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
91564082|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|0.1||||0.1524|TWO_SIDED|95.0|-0.04|0.23|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.23|-0.04|0.1524
91564083|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|0.03||||0.7086|TWO_SIDED|95.0|-0.11|0.16|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.16|-0.11|0.7086
91564084|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|-0.13||||0.0651|TWO_SIDED|95.0|-0.26|0.01|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.01|-0.26|0.0651
91564085|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|0.02||||0.7937|TWO_SIDED|95.0|-0.12|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.12|0.7937
91564086|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|-0.04||||0.5587|TWO_SIDED|95.0|-0.18|0.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.10|-0.18|0.5587
91564087|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|-0.02||||0.7285|TWO_SIDED|95.0|-0.13|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.09|-0.13|0.7285
91564088|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|0.03||||0.5802|TWO_SIDED|95.0|-0.09|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.09|0.5802
91564089|NCT02255435|183016237|SUPERIORITY||LS Mean difference (Net)|0.0||||0.9698|TWO_SIDED|95.0|-0.08|0.08|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.08|-0.08|0.9698
91564090|NCT02255435|183016238|SUPERIORITY||LS Mean difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|0.956||0.0141|TWO_SIDED|95.0|-4.31|-0.5|||Mixed Models Analysis|Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS|Difference is omaveloxolone - placebo.|||-0.50|-4.31|0.0141
91564091|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-1.81||||0.231|TWO_SIDED|95.0|-4.8|1.18|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.18|-4.80|0.2310
91564092|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-0.52||||0.7298|TWO_SIDED|95.0|-3.51|2.47|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.47|-3.51|0.7298
91564093|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-0.99||||0.5102|TWO_SIDED|95.0|-3.99|2.0|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.00|-3.99|0.5102
91564094|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-0.95||||0.5281|TWO_SIDED|95.0|-3.94|2.04|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.04|-3.94|0.5281
91564095|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-1.42||||0.3458|TWO_SIDED|95.0|-4.42|1.57|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.57|-4.42|0.3458
91564096|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-2.3||||0.0587|TWO_SIDED|95.0|-4.68|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||0.09|-4.68|0.0587
91564097|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|0.58||||0.648|TWO_SIDED|95.0|-1.94|3.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||3.10|-1.94|0.6480
91564098|NCT02255435|183016239|SUPERIORITY||LS Mean difference (Net)|-1.1||||0.2174|TWO_SIDED|95.0|-2.87|0.66|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.66|-2.87|0.2174
91564099|NCT02151643|183016240|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).||||||0.784|||||||F-test|||"ITT population - statistical analysis of linear model fit using an F-test at the 0.05 level.~It was determined that 150 subjects randomised at a ratio of 8:8:8:13:13 (low dose to high dose, placebo) would have \>90% power to detect either a statistically significant slope for the dose-response relationship, or, if the relationship was not linear, a statistically significant difference between the highest-dose group and the placebo group, using a two-sided 0.05 significance level."||||0.784
91564100|NCT02151643|183016240|OTHER|Sensitivity analysis of ITT primary analysis using baseline observation carried forward (BOCF) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.905|||||||F-test|||"ITT population sensitivity analysis using baseline observation carried forward (BOCF) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.905
91564101|NCT02151643|183016240|OTHER|Sensitivity analysis of ITT primary analysis using multiple imputation (MI) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.976|||||||F-test|||"ITT population sensitivity analysis using multiple imputation (MI) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.976
91564102|NCT02151643|183016240|OTHER|Sensitivity analysis of the primary ITT analysis using the Per Protocol (PP) population.||||||0.914|||||||F-test|||"Per protocol (PP) population sensitivity analysis to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.914
91564103|NCT02151643|183016240|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).|Slope|-0.329|||<|0.001|TWO_SIDED||||||linear model - log (dose) - response|||ITT population - statistical analysis of the linear model log(PT20 dose)-response relationship to examine whether the linear trend of the change in phosphate level as a function of the log-transformed dose was statistically significant.||||<0.001
91564104|NCT02151643|183016240|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group||||<0.001
91564105|NCT02151643|183016240|OTHER|||||||0.436|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - visit||||0.436
91564106|NCT02151643|183016240|OTHER|||||||0.959|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group versus Visit interaction||||0.959
91564107|NCT02151643|183016240|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration||||<0.001
91564108|NCT02151643|183016240|OTHER|||||||0.144|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration versus Visit interaction||||0.144
91564109|NCT02151643|183016240|OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.2847|||ONE_SIDED|97.5||0.761||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.761||
91564110|NCT02151643|183016240|OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.2881|||ONE_SIDED|97.5||0.659||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.659||
91564111|NCT02151643|183016240|OTHER||Mean Difference (Final Values)|-0.705|STANDARD_ERROR_OF_MEAN|0.2891|||ONE_SIDED|97.5||-0.05||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.05||
91564112|NCT02151643|183016240|OTHER||Mean Difference (Final Values)|-1.195|STANDARD_ERROR_OF_MEAN|0.255|||ONE_SIDED|97.5||-0.618||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.618||
91564113|NCT02151643|183016241|OTHER|||||||0.497|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by PT20 dose group.||||0.497
91564114|NCT02151643|183016241|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by baseline hemoglobin.||||<0.001
91564115|NCT02151643|183016242|OTHER|||||||0.243|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by PT20 dose group.||||0.243
91564116|NCT02151643|183016242|OTHER|||||||0.867|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by Visit.||||0.867
91564117|NCT02151643|183016242|OTHER|||||||0.186|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration||||0.186
91564118|NCT02151643|183016243|OTHER|||||||0.068|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by PT20 dose group.||||0.068
91564119|NCT02151643|183016243|OTHER|||||||0.013|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Visit.||||0.013
91564120|NCT02151643|183016243|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation.||||<0.001
91564121|NCT02151643|183016244|OTHER|||||||0.004|||||||ANCOVA|||Repeated measures ANCOVA for change in Calcium x Phosphate Product from Baseline by PT20 dose group.||||0.004
91564122|NCT02151643|183016244|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Calcium x Phosphate Product.||||<0.001
91564123|NCT02151643|183016245|OTHER|||||||0.292|||||||paired z-test|||||||0.292
91564124|NCT02151643|183016245|OTHER|||||||0.047|||||||paired z-test|||||||0.047
91564125|NCT02151643|183016245|OTHER|||||||0.872|||||||paired z-test|||||||0.872
91564126|NCT02151643|183016245|OTHER|||||||0.288|||||||paired z-test|||||||0.288
91564127|NCT04307134|183016262|OTHER||Odds Ratio (OR)|999.99|||=|0.9509|TWO_SIDED|95.0|0.01|999.99||Statistical data presented based on Multiple logistic regression including Allergic history as factor and was performed to assess whether allergic history status influenced occurrence of AEs. This model produced one effect estimate for association.|Regression, Logistic|||||999.99|0.01|=0.9509
91564128|NCT04307134|183016269|OTHER||Odds Ratio (OR)|1.03|||=|0.1488|TWO_SIDED|95.0|0.99|1.07||Multiple logistic regression including age as factor.|Regression, Logistic|||Statistical data for this outcome measure is combined for all age groups in accordance with local regulations.||1.07|0.99|=0.1488
91564129|NCT01809691|183016280|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.08|TWO_SIDED|95.0|0.72|1.02|||Regression, Cox|||||1.02|0.72|.080
91564130|NCT01809691|183016281|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.51|0.67|||Regression, Cox|||||0.67|0.51|<0.001
91564131|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.0011|TWO_SIDED|||||p-values of \<0.05 are considered significant.|Wilcoxon Signed Rank Test|||Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0011
91564132|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.1152|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.1152
91564133|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.0552|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0552
91564134|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.039|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.039
91564135|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.0223|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0223
91564136|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.4664|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.4664
91564137|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.0001|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0001
91564138|NCT03694210|183016291|SUPERIORITY||Mean Difference (Net)|0.0||||0.0639|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0639
91564139|NCT04908800|183016353|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.88|||||TWO_SIDED|90.0|1.74|2.04|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 10.7."|||2.04|1.74|
91564140|NCT04908800|183016354|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.68|||||TWO_SIDED|90.0|1.57|1.79|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 9.01."|||1.79|1.57|
91564141|NCT04908800|183016355|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.15|||||TWO_SIDED|90.0|1.09|1.21|||||Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect. Within-subject coefficient of variation was 7.18.|||1.21|1.09|
91564142|NCT04908800|183016360|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971|||||TWO_SIDED|95.0|0.882|1.06|||||Between-subject geometric coefficient of variation was 26.1. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.882|
91564143|NCT04908800|183016360|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.01|||||TWO_SIDED|95.0|0.926|1.11|||||Geometric least squares mean was 600 (fasted) and 607 (fed). Within-subject coefficient of variation was 6.01. Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect.|Food Effect Assessment||1.11|0.926|
91564144|NCT04908800|183016360|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.06|||||TWO_SIDED|95.0|0.701|1.59|||||Geometric least squares mean was 600 (fasted male) and 634 (fasted female). Between subject coefficient of variation was 32.7. Data were analyzed using an ANOVA model which included actual treatment as a factor.|Sex Effect Assessment||1.59|0.701|
91564145|NCT04908800|183016361|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.977|||||TWO_SIDED|95.0|0.891|1.06|||||Between-subject geometric coefficient of variation was 25.4. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.891|
91564146|NCT04908800|183016361|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.0|||||TWO_SIDED|95.0|0.905|1.12|||||"Geometric least squares mean was 575 (fasted) and 578 (fed). Within-subject coefficient of variation was 7.05.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.12|0.905|
91564147|NCT04908800|183016361|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.04|||||TWO_SIDED|95.0|0.707|1.54|||||"Geometric least squares mean was 575 (fasted male) and 600 (fasted female). Between subject coefficient of variation was 31.1.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.54|0.707|
91564148|NCT04908800|183016362|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.989|||||TWO_SIDED|95.0|0.909|1.07|||||Between-subject geometric coefficient of variation was 23.0. Data were analyzed using a power model.|Dose Proportionality Assessment||1.07|0.909|
91564149|NCT04908800|183016362|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.948|||||TWO_SIDED|95.0|0.824|1.09|||||"Geometric least squares mean was 31.6 (fasted) and 30.0 (fed). Within-subject coefficient of variation was 9.44.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.09|0.824|
91564150|NCT04908800|183016362|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.23|||||TWO_SIDED|95.0|0.928|1.62|||||"Geometric least squares mean was 31.6 (fasted male) and 38.8 (fasted female). Between subject coefficient of variation was 22.0.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.62|0.928|
91564151|NCT04908800|183016367|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.11|||||TWO_SIDED|95.0|0.966|1.26|||||Between-subject geometric coefficient of variation was 26.9. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.26|0.966|
91564152|NCT04908800|183016369|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12|||||TWO_SIDED|95.0|0.945|1.29|||||Between-subject geometric coefficient of variation was 32.1. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.29|0.945|
91564153|NCT04908800|183016370|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1|||||TWO_SIDED|95.0|0.971|1.23|||||Between-subject geometric of coefficient variation was 23.2. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.23|0.971|
91564154|NCT03751280|183016379|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|90.0|-1.4|2.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||2.6|-1.4|
91564155|NCT03751280|183016379|OTHER||Comparison of adjusted least square mean|0.8|STANDARD_ERROR_OF_MEAN|1.279|||TWO_SIDED|90.0|-1.3|2.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||2.9|-1.3|
91564156|NCT03751280|183016379|OTHER||Comparison of adjusted least square mean|2.73|STANDARD_ERROR_OF_MEAN|1.611||0.0931|TWO_SIDED|90.0|0.1|5.4|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||5.4|0.1|0.0931
91564157|NCT03751280|183016381|OTHER||Comparison of adjusted least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-0.6|1.0|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1|-0.6|
91564158|NCT03751280|183016381|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-0.3|1.5|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.5|-0.3|
91564159|NCT03751280|183016381|OTHER||Comparison of adjusted least square mean|0.82|STANDARD_ERROR_OF_MEAN|0.648||0.2069|TWO_SIDED|90.0|-0.3|1.9|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||1.9|-0.3|0.2069
91564160|NCT03751280|183016382|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.849|||TWO_SIDED|90.0|-0.9|1.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.9|-0.9|
91564161|NCT03751280|183016382|OTHER||Comparison of adjusted least square mean|0.12|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|-1.4|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.6|-1.4|
91564162|NCT03751280|183016382|OTHER||Comparison of adjusted least square mean|1.61|STANDARD_ERROR_OF_MEAN|1.071||0.1368|TWO_SIDED|90.0|-0.2|3.4|||t-test, 2 sided|||Day 85||3.4|-0.2|0.1368
91564163|NCT03751280|183016383|OTHER||Comparison of adjusted least square mean|-0.13|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.8|0.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||0.6|-0.8|
91564164|NCT03751280|183016383|OTHER||Comparison of adjusted least square mean|0.15|STANDARD_ERROR_OF_MEAN|0.453|||TWO_SIDED|90.0|-0.6|0.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||0.9|-0.6|
91564165|NCT03751280|183016383|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.581||0.3798|TWO_SIDED|90.0|-0.5|1.5|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|||1.5|-0.5|0.3798
91564166|NCT03751280|183016384|OTHER||Comparison of adjusted least square mean|-0.79|STANDARD_ERROR_OF_MEAN|-0.79|||TWO_SIDED|90.0|-3.2|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.6|-3.2|
91564167|NCT03751280|183016384|OTHER||Comparison of adjusted least square mean|-1.6|STANDARD_ERROR_OF_MEAN|2.006|||TWO_SIDED|90.0|-4.9|1.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.7|-4.9|
91564168|NCT03751280|183016384|OTHER||Comparison of adjusted least square mean|-4.07|STANDARD_ERROR_OF_MEAN|1.78||0.0245|TWO_SIDED|90.0|-7.0|-1.1|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||-1.1|-7.0|0.0245
91564169|NCT03751280|183016385|OTHER||Comparison of adjusted least square mean|-0.18|STANDARD_ERROR_OF_MEAN|0.516|||TWO_SIDED|90.0|-1.0|0.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29-Domain 1||0.7|-1.0|
91564170|NCT02162771|183016444|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|102.25|||||TWO_SIDED|90.0|94.05|111.17|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in AUCtau between CT-P10 and Rituxan||111.17|94.05|
91564171|NCT02162771|183016445|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|100.67|||||TWO_SIDED|90.0|93.84|108.0|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in Cmax,ss between CT-P10 and Rituxan||108.00|93.84|
91564172|NCT02162771|183016446|NON_INFERIORITY|Non-inferiority margin of -7% was predefined.|Point estimate difference|4.3|||||TWO_SIDED|||||||||||||
91564173|NCT05045638|183016509|OTHER||Ratio of GLSMs|1.6999|||||TWO_SIDED|90.0|1.186|2.4363||||||The ratios of geometric least squares means (GLSMs) and confidence intervals (CIs) were obtained by taking the exponential of the corresponding differences and CIs on the natural-log (ln) scale.||2.4363|1.1860|
91564174|NCT05045638|183016510|OTHER||Ratio of GLSMs|1.3389|||||TWO_SIDED|90.0|1.0334|1.7347||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.7347|1.0334|
91564175|NCT05045638|183016511|OTHER||Ratio of GLSMs|1.3382|||||TWO_SIDED|90.0|0.9856|1.8169||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.8169|0.9856|
91564176|NCT02849509|183016527|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
91564177|NCT02849509|183016527|OTHER|||||||0.0174||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0174
91564178|NCT02849509|183016528|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
91564179|NCT02849509|183016528|OTHER|||||||0.0004||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0004
91564180|NCT02849509|183016529|OTHER|||||||0.0423||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0423
91564181|NCT02849509|183016529|OTHER|||||||0.2226||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.2226
91564182|NCT02849509|183016530|OTHER|||||||0.0287||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0287
91564183|NCT02849509|183016530|OTHER|||||||0.03||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0300
91564184|NCT02849509|183016536|OTHER|||||||0.1234||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.1234
91564185|NCT02849509|183016536|OTHER|||||||0.974||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.9740
91564186|NCT01292005|183016541|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.62
91564187|NCT01292005|183016541|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||1.0
91564188|NCT01292005|183016542|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.72
91564189|NCT01292005|183016542|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.50
91564190|NCT01292005|183016543|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.58
91564191|NCT01292005|183016543|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.80
91564192|NCT01292005|183016544|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.90
91564193|NCT01292005|183016544|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.56
91564194|NCT01292005|183016545|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.09
91564195|NCT01292005|183016546|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.22
91564196|NCT01292005|183016547|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Comparison between arms for length of hospitalization \> 4 days. P \< 0.05 was considered statistically significant.||||0.04
91564197|NCT01292005|183016547|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Comparison was for length of hospitalization \>10 days. P \< 0.05 was considered statistically significant.||||0.03
91564198|NCT01292005|183016548|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||P \< 0.05 was considered statistically significant.||||0.06
91564199|NCT01292005|183016549|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.03
91564200|NCT01292005|183016550|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.04
91564201|NCT05431543|183016563|SUPERIORITY||Odds Ratio (OR)|83.988|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
91564202|NCT05431543|183016563|SUPERIORITY||Odds Ratio (OR)|102.093|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
91564203|NCT02924051|183016564|EQUIVALENCE|With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.|Mean Difference (Final Values)|1.12||||0.26|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.26
91564204|NCT02924051|183016566|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.||||0.36
91564205|NCT00914732|183016570|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|97.5|-1.23|-0.25||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.25|-1.23|
91564206|NCT00914732|183016571|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.83|||||TWO_SIDED|97.5|-1.32|-0.33||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.33|-1.32|
91564207|NCT00914732|183016572|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|97.5|-0.43|0.52||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.52|-0.43|
91564208|NCT00914732|183016573|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.27|||||TWO_SIDED|97.5|-0.77|0.23||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.23|-0.77|
91564209|NCT00914732|183016576|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.34|||||TWO_SIDED|97.5|-0.3|0.71||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.71|-0.3|
91564210|NCT00914732|183016577|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.02|||||TWO_SIDED|97.5|-0.31|0.35||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.35|-0.31|
91564211|NCT00914732|183016578|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|97.5|-0.74|0.04||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.04|-0.74|
91564212|NCT00914732|183016579|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x108 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x108 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Lyophilized SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|97.5|-0.81|-0.12||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||-0.12|-0.81|
91564213|NCT03005106|183016586|OTHER|Difference between treatment and control sites|Mean Difference (Final Values)|97.77|||<|0.0001|TWO_SIDED|||||Difference is (percent area of Autograft treatment site requiring autografting by Month 3) - (percent area of StrataGraft treatment site requiring autografting by Month 3).|one-sided Wilcoxin Signed RankTtest|||||||<0.0001
91564214|NCT03005106|183016587|OTHER||Percentage of participants|83.1|||||TWO_SIDED|95.0|74.4|91.8|||||95% confidence interval is derived using the normal approximation to the binomial distribution|||91.8|74.4|
91564215|NCT03005106|183016588|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|2.4|||<|0.0001|TWO_SIDED||||||1-sided, paired t-test|p-value from 1-sided, paired t-test on the mean difference(Autograft - StrataGraft)||||||<0.0001
91564216|NCT03005106|183016589|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|||||Missing total score data were imputed using a multiple imputation analysis assuming a monotone missing data pattern. A linear regression model with ethnicity, race and age as predictive variables was used in the imputation.|1-sided, paired t-test|p-value from 1-sided, paired t-test on the difference (Autograft - StrataGraft)||||||<0.0001
91564217|NCT03163472|183016590|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564218|NCT03163472|183016591|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91564219|NCT03163472|183016592|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
91564220|NCT03163472|183016593|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91564221|NCT00321672|183016596|SUPERIORITY_OR_OTHER|||||||0.0967||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group \[1.57 (90% CI: 1.12-2.35)\] was \> than the pre-specified equivalence margin ratio of 80-125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.||||0.0967
91564222|NCT00321672|183016596|SUPERIORITY_OR_OTHER|||||||0.4884||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4884
91564223|NCT00321672|183016596|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.1031
91564224|NCT00321672|183016597|SUPERIORITY_OR_OTHER|||||||0.0831||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."||||0.0831
91564225|NCT00321672|183016597|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4680
91564226|NCT00321672|183016597|SUPERIORITY_OR_OTHER|||||||0.0896||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.0896
91564227|NCT00321672|183016598|SUPERIORITY_OR_OTHER|||||||0.0662||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours NPRS Score From Baseline During Weeks 2 to 12."||||0.0662
91564228|NCT00321672|183016598|SUPERIORITY_OR_OTHER|||||||0.5582||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.5582
91564229|NCT00321672|183016598|SUPERIORITY_OR_OTHER|||||||0.0553||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.0553
91564230|NCT02389894|183016608|SUPERIORITY||Risk Difference (RD)|6.9||||0.22|TWO_SIDED|95.0|-4.2|17.9|||Chi-squared|The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||17.9|-4.2|0.22
91564231|NCT02389894|183016608|SUPERIORITY||Risk Difference (RD)|1.3||||0.84|TWO_SIDED|95.0|-11.2|13.8||The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|Chi-squared||The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||13.8|-11.2|0.84
91564232|NCT02389894|183016609|SUPERIORITY||Risk Difference (RD)|9.7||||0.08|TWO_SIDED|95.0|-1.2|20.5|||Chi-squared||The absolute difference was computed as Embol-x minus control|||20.5|-1.2|0.08
91564233|NCT02389894|183016609|SUPERIORITY||Risk Difference (RD)|-2.8||||0.61|TWO_SIDED|95.0|-13.5|7.9|||Chi-squared||The absolute difference was computed as Cardiogard minus control|||7.9|-13.5|0.61
91564234|NCT00145496|183016629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7177||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in NSA Scale total score between asenapine and olanzapine at Day 182.||||0.7177
91564235|NCT00145496|183016630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0565||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in QLS total score between asenapine and olanzapine at Day 182.||||0.0565
91564236|NCT00145496|183016631|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in body weight between asenapine and olanzapine at Day 182.||||<0.0001
91564237|NCT00924833|183016691|SUPERIORITY_OR_OTHER|||||||0.01||||||"Within subjects effects. Time: P \< 0.01. Time \* treatment: P=0.25~Bonferroni correction. Within the placebo, carvedilol and nebivolol group, p \< 0.01 for Time 3 - Time 1, and Time 3 - Time 2."|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.01
91564238|NCT00924833|183016692|SUPERIORITY_OR_OTHER||||||<|0.05||||||P \< 0.05. Bonferroni correction: p \< 0.05 nebivolol versus carvedilol|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
91564239|NCT00924833|183016693|SUPERIORITY_OR_OTHER|||||||0.93||||||Within subjects effects. Time: p = 0.03. Time \* treatment: p = 0.12.|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.93
91564240|NCT00924833|183016696|SUPERIORITY_OR_OTHER||||||<|0.05||||||ANOVA with unpaired Student's t-test, Bonferroni correction. Bonferroni correction. p = 0.05.|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
91564241|NCT06466655|183016723|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91564242|NCT06466655|183016724|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91564243|NCT03594266|183016791|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
91564244|NCT03594266|183016791|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
91564245|NCT03594266|183016792|OTHER|||||||0.5482|||||||two-sample t-test, 2-sided|||||||0.5482
91564246|NCT00449033|183016803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.401||95.0|0.83|1.16|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.||1.16|0.83|0.401
91564247|NCT00449033|183016804|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.563||95.0|0.87|1.18|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.||||1.18|0.87|0.563
91564248|NCT00449033|183016806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.008||95.0|0.71|0.97|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.97|0.71|0.008
91564249|NCT00449033|183016807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0004||95.0|0.6|0.88|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.88|0.60|0.0004
91564250|NCT00449033|183016808|SUPERIORITY_OR_OTHER||Difference in Tumour Response (CR+PR)|-1.92||||0.2733||95.0|-8.19|4.34|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||4.34|-8.19|0.2733
91564251|NCT00449033|183016809|SUPERIORITY_OR_OTHER||Difference in Disease Control|0.97||||0.3902||95.0|-5.87|7.81|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||7.81|-5.87|0.3902
91564252|NCT02032420|183016828|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated-measures MANOVA|The reported p value is for the effect of group assignment across three iterations of the assigned task.||||||<0.001
91564253|NCT02032420|183016829|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Repeated-measures MANOVA|The p value is for the effect of group assignment across three iterations of the assigned task.||||||0.004
91564254|NCT02032420|183016830|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.038
91564255|NCT02032420|183016831|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
91564256|NCT01261793|183017068|SUPERIORITY||Odds Ratio (OR)|1.024|||=|0.899|TWO_SIDED|95.0|0.71|1.477||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.477|0.710|=0.899
91564257|NCT01261793|183017068|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.716|TWO_SIDED|95.0|0.743|1.539||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.539|0.743|=0.716
91564258|NCT03305458|183017077|SUPERIORITY||||||||||||||||||To determine if child and caregiver engagement is affected by overall SPARK use, a 2-level MLM (level-1 child, level-2 provider) will be used. Engagement scores will be calculated per child and caregiver participant. An aggregate engagement score will determine if there are differences across conditions (SPARK + TF CBT vs standard TF-CBT) while accounting for the nesting providers.|||
91564259|NCT03305458|183017078|SUPERIORITY||||||||||||||||||To determine if provider fidelity is affected by overall SPARK use, a 2-level MLM (level-1 child; level-2 provider) will be used. Fidelity will be measured by the TF-CBT TPOCS-S. Providers' overall use of the toolkit will be calculated per child participant and averaged across toolkit content. Fidelity scores will be calculated per child participant such that each provider will have three ratings. An aggregate fidelity score will determine if there are differences across conditions (SPARK + TF-CBT vs. standard TF-CBT) while accounting for the nesting of providers.|||
91564260|NCT03305458|183017079|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-to provider.|||
91564261|NCT03305458|183017080|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564262|NCT03305458|183017081|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564263|NCT03305458|183017082|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564264|NCT03305458|183017083|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564265|NCT03305458|183017084|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564266|NCT03305458|183017085|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
91564267|NCT03305458|183017086|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
91564268|NCT03305458|183017087|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
91564269|NCT03305458|183017088|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564270|NCT03305458|183017089|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564271|NCT03305458|183017090|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564272|NCT03305458|183017091|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564273|NCT03305458|183017092|SUPERIORITY||||||||||||||||||response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
91564274|NCT03305458|183017093|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564275|NCT03305458|183017094|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564276|NCT03305458|183017095|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564277|NCT03305458|183017096|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564278|NCT03305458|183017097|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
91564279|NCT05615870|183017108|SUPERIORITY||Mean Difference (Final Values)|5.41||||0.537|TWO_SIDED|95.0|-11.77|22.6|||Mixed Models Analysis|||Null hypothesis: mean of SFDs in the HEPA filtration home intervention group will not differ from the mean of SFDs in the control group||22.60|-11.77|0.537
91564280|NCT05615870|183017109|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.205|TWO_SIDED|95.0|-0.07|0.3|||Mixed Models Analysis|||Null hypothesis: mean of counts of hospitalizations for respiratory symptoms in the intervention group will not differ from the mean of counts of hospitalizations for respiratory symptoms in the control group||0.30|-0.07|0.205
91564281|NCT05615870|183017109|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.35|0.35|||Mixed Models Analysis|||Null hypothesis: mean of counts of emergency department or urgent care visits for respiratory symptoms in the intervention group will not differ from the mean of counts of emergency department or urgent care visits for respiratory symptoms in the control group||0.35|-0.35|0.992
91564282|NCT05615870|183017109|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.172|TWO_SIDED|95.0|-0.9|0.16|||Mixed Models Analysis|||Null hypothesis: mean of counts of other unscheduled healthcare visits for respiratory symptoms in the intervention group will not differ from the mean of counts of other unscheduled healthcare visits for respiratory symptoms in the control group||0.16|-0.90|0.172
91564283|NCT05615870|183017109|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.53|TWO_SIDED|95.0|-1.02|0.52|||Mixed Models Analysis|||Null hypothesis: mean of counts (or total counts) of visits of all metrics for respiratory symptoms in the intervention group will not differ from the mean of counts of visits of all metrics for respiratory symptoms in the control group||0.52|-1.02|0.530
91564284|NCT05615870|183017110|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.598|TWO_SIDED|95.0|-3.75|2.16|||Mixed Models Analysis|||Null hypothesis: mean of the Child QOL score in the HEPA intervention group will not differ from the mean of Child QOL score in the control group||2.16|-3.75|0.598
91564285|NCT05615870|183017111|SUPERIORITY||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.98|-3.42|||Mixed Models Analysis||The results were based on the average PM2.5 level of common room and sleep space.|Null hypothesis: the mean of the PM2.5 level of the common room and sleep space in the intervention group will not differ from the mean of the PM2.5 level in the control group||-3.42|-10.98|<0.001
91564286|NCT03926117|183017137|SUPERIORITY||Median Difference (Final Values)|-66.2|||<|0.0001|TWO_SIDED|95.0|-86.15|-49.12|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (greater than or equal to (\>=) 11 or less than (\<) 11 grams per deciliter (g/dL)) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-49.12|-86.15|<0.0001
91564287|NCT03926117|183017137|SUPERIORITY||Median Difference (Final Values)|-77.71|||<|0.0001|TWO_SIDED|95.0|-94.98|-62.97|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-62.97|-94.98|<0.0001
91564288|NCT03926117|183017137|SUPERIORITY||Median Difference (Final Values)|-87.76|||<|0.0001|TWO_SIDED|95.0|-101.0|-70.54|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-70.54|-101.00|<0.0001
91564289|NCT03247985|183017163|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Comparison between groups for bilateral operative time.||||0.17
91564290|NCT03247985|183017163|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Comparison between groups for unilateral operative time.||||0.09
91564291|NCT03247985|183017166|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||A p-value of 0.05 was considered statistically significant.||||0.02
91564292|NCT02577315|183017168|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.1|||||TWO_SIDED|90.0|97.466|102.804|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.804|97.466|
91564293|NCT02577315|183017169|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|95.51|||||TWO_SIDED|90.0|89.29|102.16|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.16|89.29|
91564294|NCT02577315|183017170|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|102.71|||||TWO_SIDED|90.0|97.309|108.413|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||108.413|97.309|
91564295|NCT02577315|183017171|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|101.07|||||TWO_SIDED|90.0|95.565|106.902|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||106.902|95.565|
91564296|NCT02577315|183017172|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.3|||||TWO_SIDED|90.0|97.532|103.149|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||103.149|97.532|
91564297|NCT02577315|183017173|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|93.55|||||TWO_SIDED|90.0|82.86|105.61|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||105.61|82.86|
91564298|NCT01245699|183017175|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91564299|NCT01245699|183017176|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91564300|NCT01245699|183017177|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
91564301|NCT01245699|183017178|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
91564302|NCT01636778|183017181|SUPERIORITY_OR_OTHER||Percentage|88.0|||||TWO_SIDED|95.0|74.0|96.0||||||||96|74|
91564303|NCT03530345|183017244|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.404||0.0111|TWO_SIDED|95.0|-1.89|-0.26||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||-0.26|-1.89|0.0111
91564304|NCT00748098|183017263|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-26.0|||<|0.0001|TWO_SIDED|95.0|-35.64|-16.36|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-16.36|-35.64|<0.0001
91564305|NCT00748098|183017264|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-3.07||||0.002|TWO_SIDED|95.0|-5.04|-1.1|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-1.10|-5.04|0.002
91564306|NCT02938520|183017293|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB - ABC/DTG/3TC) is less than 6%.|Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-2.8|2.1|||||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|2.1|-2.8|
91564307|NCT02938520|183017294|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - ABC/DTG/3TC) is more than -10%|Adjusted difference in proportion|0.4|||||TWO_SIDED|95.0|-3.7|4.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|||4.5|-3.7|
91564308|NCT02938520|183017347|OTHER||||||<|0.001||||||Week 41/48 was compared with the 1st visit (Week 5) based on Wilcoxon signed-rank test, respectively. p-values are derived for 'Acceptance' only and not adjusted for multiple testing.|Wilcoxon (Mann-Whitney)|||||||<0.001
91564309|NCT02938520|183017349|OTHER||Adjusted difference|1.2||||0.307|TWO_SIDED|95.0|-1.1|3.6|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.6|-1.1|0.307
91564310|NCT02938520|183017349|OTHER||Adjusted difference|0.9||||0.472|TWO_SIDED|95.0|-1.5|3.2|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.2|-1.5|0.472
91564311|NCT02938520|183017350|OTHER||Adjusted difference|1.8||||0.116|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.9|-0.4|0.116
91564312|NCT02938520|183017350|OTHER||Adjusted difference|0.1||||0.944|TWO_SIDED|95.0|-2.3|2.5|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.5|-2.3|0.944
91564313|NCT02938520|183017351|OTHER||Adjusted difference|-1.3||||0.552|TWO_SIDED|95.0|-5.7|3.0|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.0|-5.7|0.552
91564314|NCT02938520|183017351|OTHER||Adjusted difference|-4.6||||0.033|TWO_SIDED|95.0|-8.9|-0.4|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||-0.4|-8.9|0.033
91564315|NCT02938520|183017352|OTHER||Adjusted difference|1.021||||0.122|TWO_SIDED|95.0|-0.275|2.318|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.318|-0.275|0.122
91564316|NCT02938520|183017352|OTHER||Adjusted difference|1.103||||0.109|TWO_SIDED|95.0|-0.248|2.453|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.453|-0.248|0.109
91564317|NCT02938520|183017352|OTHER||Adjusted difference|0.182||||0.645|TWO_SIDED|95.0|-0.594|0.958|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.958|-0.594|0.645
91564318|NCT02938520|183017352|OTHER||Adjusted difference|-0.169||||0.689|TWO_SIDED|95.0|-0.994|0.657|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.657|-0.994|0.689
91564319|NCT02938520|183017353|OTHER||Adjusted difference|2.2|||<|0.001|TWO_SIDED|95.0|1.0|3.4|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.4|1.0|<0.001
91564320|NCT02938520|183017353|OTHER||Adjusted difference|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||1.9|-0.4|0.217
91564321|NCT02938520|183017354|OTHER||Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.8|5.5|||ANOVA||Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.5|2.8|<0.001
91564322|NCT02938520|183017356|OTHER||Adjusted difference|2.2||||0.232|TWO_SIDED|95.0|-1.4|5.7|||ANCOVA||Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.7|-1.4|0.232
91564323|NCT02938520|183017356|OTHER||Adjusted difference|2.7||||0.154|TWO_SIDED|95.0|-1.0|6.4|||ANCOVA||Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||6.4|-1.0|0.154
91564324|NCT02938520|183017356|OTHER||Adjusted difference|2.2||||0.236|TWO_SIDED|95.0|-1.4|5.8|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.8|-1.4|0.236
91564325|NCT04448561|183017376|OTHER||Geometric Least square (LS) mean ratio|100.64|||||TWO_SIDED|90.0|98.37|102.96|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||102.96|98.37|
91564326|NCT04448561|183017377|OTHER||Geometric LS mean ratio|94.28|||||TWO_SIDED|90.0|89.29|99.54|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||99.54|89.29|
91564327|NCT04448561|183017379|OTHER||Geometric LS mean ratio|100.79|||||TWO_SIDED|90.0|83.35|121.88|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||121.88|83.35|
91564328|NCT04448561|183017380|OTHER||Geometric LS mean ratio|100.58|||||TWO_SIDED|90.0|81.35|124.36|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||124.36|81.35|
91564329|NCT04448561|183017382|OTHER||Geometric LS mean ratio|89.08|||||TWO_SIDED|90.0|79.58|99.71|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||99.71|79.58|
91564330|NCT04448561|183017383|OTHER||Geometric LS mean ratio|96.11|||||TWO_SIDED|90.0|83.03|111.25|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||111.25|83.03|
91564331|NCT04448561|183017385|OTHER||Geometric LS mean ratio|86.54|||||TWO_SIDED|90.0|76.01|98.52|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||98.52|76.01|
91564332|NCT04448561|183017386|OTHER||Geometric LS mean ratio|95.1|||||TWO_SIDED|90.0|82.52|109.6|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||109.60|82.52|
91564333|NCT05492786|183017402|SUPERIORITY|||||||0.517||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts with information about their risk status (patients randomized to the High-risk Alert or High-risk Alert with Risk Factors arms) compared with those whose clinicians were shown the standard alert. Alternative hypothesis: patients in the High-risk Alert and High-risk Alert with Risk Factors arms will exhibit improved flu vaccination rates compared with those in the standard Alert arm.||||0.517
91564334|NCT05492786|183017402|SUPERIORITY|||||||0.226||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts the factors that contributed to a patient's high risk (High-risk Alert with Risk Factors arm) compared with those whose clinicians were shown the alert with risk level only (High-risk Alert arm). Alternative hypothesis: patients in the High-risk Alert with Risk Factors arm will exhibit improved flu vaccination rates compared with those in the High-risk Alert arm.||||0.226
91564335|NCT00197106|183017449|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).|Adjusted difference|2.6||||0.63||95.0|-8.1|13.4|||Repeated Measurements Anal. of Variance|Anal. = Analysis||||13.4|-8.1|0.63
91564336|NCT00609245|183017497|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||||||0.016
91564337|NCT02236598|183017498|SUPERIORITY|||||||0.5582|||||||ANCOVA|||||||0.5582
91564338|NCT02236598|183017499|SUPERIORITY|Change in Fasting Glucose||||||0.0963|||||||ANCOVA|||||||0.0963
91564339|NCT02236598|183017499|SUPERIORITY|Change in 1-hour Glucose||||||0.6671|||||||ANCOVA|||||||0.6671
91564340|NCT02236598|183017499|SUPERIORITY|Change in 2-hour Glucose||||||0.7913|||||||ANCOVA|||||||0.7913
91564341|NCT02236598|183017500|SUPERIORITY|||||||0.5294|||||||ANCOVA|||||||0.5294
91564342|NCT02236598|183017501|SUPERIORITY|||||||0.1604|||||||ANCOVA|||||||0.1604
91564343|NCT01614899|183017549|SUPERIORITY||LS Mean difference|-4.8||||0.05|TWO_SIDED|95.0|-9.52|0.0|||Mixed Model for Repeated Measures|||||0.00|-9.52|0.050
91564344|NCT01614899|183017549|SUPERIORITY||LS Mean difference|-4.2||||0.08|TWO_SIDED|95.0|-8.91|0.5|||Mixed Model for Repeated Measures|||||0.50|-8.91|0.080
91564345|NCT01614899|183017550|SUPERIORITY||LS Mean difference|-0.08||||0.594|TWO_SIDED|95.0|-0.354|0.203|||Mixed Model for Repeated Measures|||||0.203|-0.354|0.594
91564346|NCT01614899|183017550|SUPERIORITY||LS Mean difference|-0.18||||0.199|TWO_SIDED|95.0|-0.453|0.095|||Mixed Model for Repeated Measures|||||0.095|-0.453|0.199
91564347|NCT01614899|183017551|SUPERIORITY||LS Mean difference|-1.1||||0.143|TWO_SIDED|95.0|-2.6|0.38|||Mixed Model for Repeated Measures|||||0.38|-2.60|0.143
91564348|NCT01614899|183017551|SUPERIORITY||LS Mean difference|-1.9||||0.01|TWO_SIDED|95.0|-3.4|-0.46|||Mixed Model for Repeated Measures|||||-0.46|-3.40|0.010
91564349|NCT01614899|183017552|SUPERIORITY||LS Mean difference|-1.0||||0.116|TWO_SIDED|95.0|-2.27|0.25|||Mixed Model for Repeated Measures|||||0.25|-2.27|0.116
91564350|NCT01614899|183017552|SUPERIORITY||LS Mean difference|-0.5||||0.388|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model for Repeated Measures|||||0.70|-1.80|0.388
91564351|NCT01614899|183017553|SUPERIORITY||LS Mean difference|-2.5||||0.036|TWO_SIDED|95.0|-4.87|-0.17|||Mixed Model for Repeated Measures|||||-0.17|-4.87|0.036
91564352|NCT01614899|183017553|SUPERIORITY||LS Mean difference|-1.6||||0.174|TWO_SIDED|95.0|-3.93|0.72|||Mixed Model for Repeated Measures|||||0.72|-3.93|0.174
91564353|NCT00980954|183017623|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.56|TWO_SIDED|90.0|0.65|1.68||One-sided significance level = 0.05.|Log Rank||Reference level = Arm I|Sample size calculations are based on the primary hypothesis that 4 additional cycles of carboplatin and paclitaxel following concurrent radiation and weekly cisplatin will increase 4-year DFS from 80% to 90% for patients with cervical carcinoma with positive nodes and/or positive margins after a radical hysterectomy. One-sided alpha=0.05, statistical power=80%, 5.5 years of accrual with 4 years of follow-up, 2 interim significance tests. 50 DFS events are required to trigger this analysis.||1.68|0.65|0.56
91564354|NCT00980954|183017624|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.4|TWO_SIDED|90.0|0.49|1.69||One-sided significance level = 0.05.|Log Rank|||The 4-year overall survival rate for the control arm is expected to be approximately 85%. The overall survival will be compared between the two arms. The final targeted sample size of 235 patients with the longer accrual time, will provide 64% and 78% power to detect an increase in overall survival to 92% and 93% respectively, with a 1- sided alpha of 0.05.||1.69|0.49|0.40
91564355|NCT04803214|183017655|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
91564356|NCT04803214|183017656|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91564357|NCT04803214|183017657|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91564358|NCT00581009|183017658|EQUIVALENCE|repeated measure ANOVA|t-value|3.34|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
91564359|NCT02256488|183017659|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.||1.5|0.667|
91564360|NCT02256488|183017659|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22||1.5|0.667|
91564361|NCT02256488|183017659|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.12|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22||1.5|0.667|
91564362|NCT04150250|183017711|SUPERIORITY||Difference in Median|-7.1||||0.2254|TWO_SIDED|95.0|-30.9|28.6||The threshold to define success on the primary efficacy endpoint at the final analysis is one-sided alpha = 0.0238.|Van Elteren test|Stratified by blood type group (O vs. Non-O)||||28.6|-30.9|0.2254
91564363|NCT04150250|183017712|SUPERIORITY||Difference in Median|-3.8||||0.2751|TWO_SIDED|95.0|-26.3|27.4|||Van Elteren test|Stratified by blood type group||||27.4|-26.3|0.2751
91564364|NCT04150250|183017714|SUPERIORITY||Difference|-11.3||||0.5145|TWO_SIDED|95.0|-44.1|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||21.6|-44.1|0.5145
91564365|NCT04150250|183017715|SUPERIORITY||Difference|-6.3||||0.2636|TWO_SIDED|95.0|-18.1|5.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||5.6|-18.1|0.2636
91564366|NCT04150250|183017716|SUPERIORITY||Difference in Median|1.1||||0.5992|TWO_SIDED|95.0|-4.5|7.8|||Van Elteren test|Stratified by blood type group||||7.8|-4.5|0.5992
91564367|NCT04150250|183017718|SUPERIORITY|||||||0.6527|||||||Log Rank|Stratified by blood type group||||||0.6527
91564368|NCT04150250|183017719|SUPERIORITY||Difference in Median|1.5||||0.5377|TWO_SIDED|95.0|-7.0|5.5|||Van Elteren test|Stratified by blood type group||||5.5|-7.0|0.5377
91564369|NCT04150250|183017720|SUPERIORITY||Difference|1.3||||0.8705|TWO_SIDED|95.0|-14.0|16.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||16.5|-14.0|0.8705
91564370|NCT04150250|183017721|SUPERIORITY||Difference|-18.8||||0.1404|TWO_SIDED|95.0|-41.1|3.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group||||3.6|-41.1|0.1404
91564371|NCT01436045|183017724|SUPERIORITY_OR_OTHER||Percent Change|-15.7|STANDARD_ERROR_OF_MEAN|7.0|<|0.05|TWO_SIDED|||||RBANS Line Orientation|t-test, 2 sided||Response to intranasal Insulin Glulisine \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%|Response to intranasal Insulin Gluiline \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%||||<0.05
91564372|NCT01436045|183017727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Difference in errors \[result post-insulin - result post-placebo\]||||<0.05
91564373|NCT05379023|183017754|OTHER|Intraclass correlation coefficient (ICC)|IntraClassCorrelation|0.67|||||TWO_SIDED|95.0|0.5|0.78||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Memory, CVLT delayed recall shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Memory: CVLT shown below."||0.78|0.50|
91564374|NCT05379023|183017754|OTHER|Intraclass correlation coefficient (ICC)|Intraclass Correlation|0.74|||||TWO_SIDED|95.0|0.71|0.84||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Memory, RBANS delayed recall shown|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Memory: RBANS shown below."||0.84|0.71|
91564375|NCT05379023|183017754|OTHER|Intraclass correlation coefficient (ICC)|Intraclass correlation|0.85|||||TWO_SIDED|95.0|0.76|0.9||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Language, BNT-15 shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Memory: BNT-15 shown below."||0.90|0.76|
91564376|NCT05379023|183017754|OTHER|Intraclass correlation coefficient (ICC)|intraclass correlation|0.76|||||TWO_SIDED|95.0|0.63|0.85||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Language, Category Fluency shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Lang8age: Category Fluency shown below."||0.85|0.63|
91564377|NCT05379023|183017754|OTHER|Intraclass correlation coefficient (ICC)|Intraclass correlation|0.62|||||TWO_SIDED|95.0|0.45|0.75||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Spatial, JoLO-15 item shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Spatial: JoLO 15-item Total"||0.75|0.45|
91564378|NCT05379023|183017754|OTHER|Intraclass correlation|Intraclass correlation|0.57|||||TWO_SIDED|95.0|0.38|0.72||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Spatial, RBANS Figure Copy shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Spatial: RBANS Figure Copy shown below."||0.72|0.38|
91564379|NCT05379023|183017755|OTHER|Cohen's Kappa|Cohen's Kappa|0.74|||||TWO_SIDED|95.0|0.6|0.88||Not applicable, Cohen's Kappa with level of agreement between neuropsychologists used.||||"We constructed 3x3 tables for the diagnostic considerations by core battery and syndrome impression by condition. Agreement between each question and impression category was determined using Cohen's kappa (unweighted). Kappa values were interpreted using the agreement categories as follows: 0-.20 as None, .21-.39 as Minimal, .40-.59"||0.88|0.60|
91564380|NCT05379023|183017756|OTHER|Cohen's Kappa|Cohen's Kappa|0.89|||||TWO_SIDED|95.0|0.79|0.99||Not applicable, Cohen's Kappa with level of agreement between neuropsychologists used.||||"We constructed 3x3 tables for the diagnostic considerations by core battery and severity impression by condition. Agreement between each question and impression category was determined using Cohen's kappa (unweighted). Kappa values were interpreted using the agreement categories as follows: 0-.20 as None, .21-.39 as Minimal, .40-.59"||0.99|0.79|
91564381|NCT05379023|183017759|OTHER|Intraclass correlation coefficient (ICC)|Intraclass correlation|0.82|||||TWO_SIDED|95.0|0.71|0.89||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Executive Functions, DKEFS Color Word-Inhibition shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Executive Functions: DKEFS Color Word Inhibition shown below."||0.89|0.71|
91564382|NCT05379023|183017759|OTHER|Intraclass correlation coefficient (ICC)|Intraclass correlation|0.88|||||TWO_SIDED|95.0|0.81|0.93||"ICC estimates and 95% CIs were interpreted as agreement across condition type, where estimates of 0-\<0.50 are considered poor, 0.50≤-\<0.75 moderate, 0.75≤-\<0.90 good, and 0.90≤-1 excellent.~ICCs were adjusted for age and sex."||Not applicable, ICC level of agreements interpreted.|ICC with 95% CI for Executive Functions, Oral Trail Making Test B shown.|"Unadjusted intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated for each outcome measure to assess the reliability of measures across condition type based on a single-rating, absolute-agreement, two-way random-effects model.~Results for Executive Functions:Oral Trail Making Test B shown below."||0.93|0.81|
91564383|NCT03602859|183017769|OTHER||Hazard Ratio (HR)|0.85||||0.0351|TWO_SIDED|95.0|0.73|0.99|||Stratified log-rank test||Hazard ratio and p-value from the stratified Cox proportional hazards model and log-rank test (2-sided) are adjusted for the randomization stratification factors: concurrent bevacizumab use and homologous recombinant repair (HRR) mutation status.|||0.99|0.73|0.0351
91564384|NCT00377312|183017795|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
91564385|NCT00377312|183017796|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
91564386|NCT00377312|183017797|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
91564387|NCT00377312|183017798|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
91564388|NCT00377312|183017799|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.05
91564389|NCT00377312|183017800|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
91564390|NCT00377312|183017802|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.61
91564391|NCT00377312|183017803|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
91564392|NCT00377312|183017803|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
91564393|NCT00377312|183017804|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
91564394|NCT00377312|183017804|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
91564395|NCT00377312|183017805|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
91564396|NCT00377312|183017805|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups||||||.01
91564397|NCT00377312|183017806|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
91564398|NCT00382408|183017810|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|99.31|||||TWO_SIDED|95.0|96.02|99.88||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.88|96.02|
91564399|NCT00382408|183017815|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|98.46|||||TWO_SIDED|95.0|95.39|99.49||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.49|95.39|
91564400|NCT03924947|183017820|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|Least Squares (LS) Mean of Difference|0.94|STANDARD_ERROR_OF_MEAN|1.176|||TWO_SIDED|99.0|-2.37|4.259|||||LS mean (standard error \[SE\]) and LS mean confidence interval (CI) are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon MP||4.259|-2.370|
91564401|NCT03924947|183017821|OTHER|Descriptive|LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-2.456|2.392|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||2.392|-2.456|
91564402|NCT03924947|183017821|OTHER|Descriptive|LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.035|||TWO_SIDED|95.0|-3.005|1.345|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon AAPIS||1.345|-3.005|
91564403|NCT03924947|183017822|OTHER|Descriptive|LS Mean of Difference|-3.36|STANDARD_ERROR_OF_MEAN|3.541|||TWO_SIDED|95.0|-10.699|3.987|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||3.987|-10.699|
91564404|NCT03924947|183017822|OTHER|Descriptive|LS Mean of Difference|3.27|STANDARD_ERROR_OF_MEAN|4.016|||TWO_SIDED|95.0|-5.172|11.702|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||11.702|-5.172|
91564405|NCT03924947|183017823|OTHER|Descriptive|LS Mean of Difference|34.68|STANDARD_ERROR_OF_MEAN|62.253|||TWO_SIDED|95.0|-94.424|163.786|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||163.786|-94.424|
91564406|NCT03924947|183017823|OTHER|Descriptive|LS Mean of Difference|-16.56|STANDARD_ERROR_OF_MEAN|60.858|||TWO_SIDED|95.0|-144.418|111.298|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||111.298|-144.418|
91564407|NCT03924947|183017824|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|LS Mean of Difference|-1.15|STANDARD_ERROR_OF_MEAN|1.302|||TWO_SIDED|99.0|-4.892|2.602|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon AAPIS||2.602|-4.892|
91564408|NCT03451292|183017845|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.17|TWO_SIDED|95.0|0.58|1.1|||Cox Proportional- Hazards (PH) model|||Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).||1.10|0.58|0.17
91564409|NCT01090076|183017909|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||t-test, 2 sided|||||||0.023
91564410|NCT01090076|183017910|SUPERIORITY_OR_OTHER|||||||0.877||95.0|||||t-test, 2 sided|||||||0.877
91564411|NCT01090076|183017911|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
91564412|NCT02253147|183017931|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.34|-0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||-0.11|-0.34|
91564413|NCT00694564|183017976|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was calculated as this was a pilot study to determine such parameters.||||||0.004||95.0|||||MANOVA|||||||0.004
91564414|NCT02402465|183017978|SUPERIORITY||Mean Difference (Final Values)|37.0|||>|0.05|TWO_SIDED||||||ANOVA||Mean difference is related to albumin levels in nasal lavages: Unit= ng/ml|||||>0.05
91564415|NCT02402465|183017979|SUPERIORITY||Friedman's Q|14.2||||0.001|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately yielding alpha=0.05/3.|Friedman|Non-parametric repeated measures ANOVA||||||0.001
91564416|NCT02402465|183017979|SUPERIORITY||Median Difference (Net)|24.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
91564417|NCT02402465|183017979|SUPERIORITY||Median Difference (Net)|4.5||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
91564418|NCT02402465|183017979|SUPERIORITY||Median Difference (Net)|48.5||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.53
91564419|NCT02402465|183017980|SUPERIORITY||Friedman's Q|5.22||||0.07|TWO_SIDED|||||Alpha=0.05/3 since 3 days are compared|Friedman's Test|||We used Friedman test to compare the distribution of total nasal symptom scores among three treatment groups (Placebo, Fluticasone propionate, Dymista) in each of the three days (day 1, day 2, and day 3).||||0.07
91564420|NCT02402465|183017981|SUPERIORITY||Friedman's Q|5.06||||0.08|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.08
91564421|NCT02402465|183017983|SUPERIORITY||Friedman's Q|6.53||||0.04|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.04
91564422|NCT02402465|183017984|SUPERIORITY||Friedman's Q|0.53|||>|0.05|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||>0.05
91564423|NCT02402465|183017985|SUPERIORITY||Friedman's Q|0.33||||0.85|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.85
91564424|NCT01284634|183017986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89|STANDARD_ERROR_OF_MEAN|5.454||0.222|TWO_SIDED|90.0|-16.35|2.56|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||2.56|-16.35|0.222
91564425|NCT01284634|183017986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.35|STANDARD_ERROR_OF_MEAN|5.943||0.133|TWO_SIDED|90.0|-19.66|0.95|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||0.95|-19.66|0.133
91564426|NCT01284634|183017986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|6.158||0.302|TWO_SIDED|90.0|-17.22|4.14|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||4.14|-17.22|0.302
91564427|NCT03807700|183017992|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.58||0.4769|TWO_SIDED|95.0|-1.56|0.74|||ANCOVA|Analysis was performed using ANCOVA model with study product as a fixed effect and Baseline overall score as a covariate.|Difference is experimental adhesive minus no adhesive.|||0.74|-1.56|0.4769
91564428|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||5.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000559
91564429|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||7.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2812338||||0.00000766
91564430|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs10824875||||0.00000982
91564431|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||1.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000127
91564432|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||3.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs10851257||||0.00000396
91564433|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||6.48e-06|TWO_SIDED||||||t-test, 2 sided|||rs6492344||||0.00000648
91564434|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs12584550||||0.00000221
91564435|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||9.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs9555773||||0.00000902
91564436|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000077
91564437|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000048
91564438|NCT01855997|183018038|SUPERIORITY_OR_OTHER|||||||3.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000037
91564439|NCT01855997|183018039|SUPERIORITY_OR_OTHER|||||||9.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000987
91564440|NCT01855997|183018039|SUPERIORITY_OR_OTHER|||||||6.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs7753766||||0.00000605
91564441|NCT01855997|183018039|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs604241||||0.00000946
91564442|NCT01855997|183018039|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000077
91564443|NCT01855997|183018039|SUPERIORITY_OR_OTHER|||||||1.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000197
91564444|NCT01855997|183018040|SUPERIORITY_OR_OTHER|||||||6.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000677
91564445|NCT01855997|183018040|SUPERIORITY_OR_OTHER|||||||7.98e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000798
91564446|NCT01855997|183018040|SUPERIORITY_OR_OTHER|||||||5.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000512
91564447|NCT01855997|183018040|SUPERIORITY_OR_OTHER|||||||3.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000345
91564448|NCT01855997|183018040|SUPERIORITY_OR_OTHER|||||||3.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000372
91564449|NCT01855997|183018041|SUPERIORITY_OR_OTHER|||||||4.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000459
91564450|NCT01855997|183018041|SUPERIORITY_OR_OTHER|||||||9.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs1411283||||0.00000925
91564451|NCT01855997|183018041|SUPERIORITY_OR_OTHER|||||||7.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000772
91564452|NCT01855997|183018042|SUPERIORITY_OR_OTHER|||||||4.7e-06|TWO_SIDED||||||t-test, 2 sided|||rs11163805||||0.00000470
91564453|NCT01855997|183018042|SUPERIORITY_OR_OTHER|||||||6.74e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000674
91564454|NCT01855997|183018042|SUPERIORITY_OR_OTHER|||||||9.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000952
91564455|NCT01855997|183018042|SUPERIORITY_OR_OTHER|||||||6.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000608
91564456|NCT01855997|183018042|SUPERIORITY_OR_OTHER|||||||4.04e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000404
91564457|NCT01855997|183018042|SUPERIORITY_OR_OTHER|||||||4.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000407
91564458|NCT01855997|183018043|SUPERIORITY_OR_OTHER|||||||6.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000666
91564459|NCT01855997|183018043|SUPERIORITY_OR_OTHER|||||||8.44e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000844
91564460|NCT01855997|183018043|SUPERIORITY_OR_OTHER|||||||7.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000794
91564461|NCT01855997|183018043|SUPERIORITY_OR_OTHER|||||||3.1e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000310
91564462|NCT01855997|183018044|SUPERIORITY_OR_OTHER|||||||2.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000207
91564463|NCT01855997|183018044|SUPERIORITY_OR_OTHER|||||||8.99e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000899
91564464|NCT01855997|183018045|SUPERIORITY_OR_OTHER|||||||5.73e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000573
91564465|NCT01855997|183018045|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000946
91564466|NCT01855997|183018045|SUPERIORITY_OR_OTHER|||||||7.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000731
91564467|NCT01855997|183018045|SUPERIORITY_OR_OTHER|||||||9.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs646097||||0.00000945
91564468|NCT01855997|183018046|SUPERIORITY_OR_OTHER|||||||1.6e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000016
91564469|NCT01855997|183018047|SUPERIORITY_OR_OTHER|||||||8.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000088
91564470|NCT01855997|183018048|SUPERIORITY_OR_OTHER|||||||8.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs2464266||||0.00000879
91564471|NCT01855997|183018049|SUPERIORITY_OR_OTHER|||||||4.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs9496139||||0.00000452
91564472|NCT01855997|183018049|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2014238||||0.00000497
91564473|NCT01855997|183018049|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2980231||||0.00000497
91564474|NCT01855997|183018050|SUPERIORITY_OR_OTHER|||||||7.48e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000748
91564475|NCT01855997|183018050|SUPERIORITY_OR_OTHER|||||||7.3e-07|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000073
91564476|NCT01855997|183018050|SUPERIORITY_OR_OTHER|||||||2.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs2899723||||0.00000289
91564477|NCT01855997|183018050|SUPERIORITY_OR_OTHER|||||||9.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs8027115||||0.00000912
91564478|NCT01855997|183018050|SUPERIORITY_OR_OTHER|||||||4.94e-06|TWO_SIDED||||||t-test, 2 sided|||exm2267780||||0.00000494
91564479|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||6.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs9973954||||0.00000627
91564480|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||6.96e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000696
91564481|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||4.26e-06|TWO_SIDED||||||t-test, 2 sided|||rs1040084||||0.00000426
91564482|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||4.35e-06|TWO_SIDED||||||t-test, 2 sided|||rs1913484||||0.00000435
91564483|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000221
91564484|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||5.23e-06|TWO_SIDED||||||t-test, 2 sided|||exm1010813||||0.00000523
91564485|NCT01855997|183018051|SUPERIORITY_OR_OTHER|||||||7.57e-06|TWO_SIDED||||||t-test, 2 sided|||rs6576456||||0.00000757
91564486|NCT01855997|183018052|SUPERIORITY_OR_OTHER|||||||1.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000153
91564487|NCT01855997|183018052|SUPERIORITY_OR_OTHER|||||||7.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs10475403||||0.00000708
91564488|NCT01855997|183018052|SUPERIORITY_OR_OTHER|||||||7.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000727
91564489|NCT01855997|183018053|SUPERIORITY_OR_OTHER|||||||3.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000397
91564490|NCT01855997|183018054|SUPERIORITY_OR_OTHER|||||||6.86e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000686
91564491|NCT01855997|183018054|SUPERIORITY_OR_OTHER|||||||5.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000596
91564492|NCT01855997|183018054|SUPERIORITY_OR_OTHER|||||||4.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000489
91564493|NCT01855997|183018055|SUPERIORITY_OR_OTHER|||||||8.34e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000834
91564494|NCT01855997|183018055|SUPERIORITY_OR_OTHER|||||||4.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000487
91564495|NCT01855997|183018055|SUPERIORITY_OR_OTHER|||||||9.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000918
91564496|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||1.37e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000137
91564497|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||3.39e-06|TWO_SIDED||||||t-test, 2 sided|||rs2803073||||0.00000339
91564498|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||9.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1937590||||0.00000927
91564499|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||1.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000166
91564500|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||4.55e-06|TWO_SIDED||||||t-test, 2 sided|||rs1997894||||0.00000455
91564501|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||5.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs1495471||||0.00000568
91564502|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||1.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000125
91564503|NCT01855997|183018056|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs1152537||||0.00000982
91564504|NCT01855997|183018057|SUPERIORITY_OR_OTHER|||||||8.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs10236906||||0.00000846
91564505|NCT01855997|183018057|SUPERIORITY_OR_OTHER|||||||5.62e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000562
91564506|NCT01855997|183018057|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs7042473||||0.00000497
91564507|NCT01855997|183018057|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2077415||||0.00000997
91564508|NCT01855997|183018057|SUPERIORITY_OR_OTHER|||||||8.64e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000864
91564509|NCT01855997|183018058|SUPERIORITY_OR_OTHER|||||||3.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000368
91564510|NCT01855997|183018058|SUPERIORITY_OR_OTHER|||||||5.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000577
91564511|NCT01855997|183018059|SUPERIORITY_OR_OTHER|||||||9.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs2302503||||0.00000950
91564512|NCT01855997|183018059|SUPERIORITY_OR_OTHER|||||||7.41e-06|TWO_SIDED||||||t-test, 2 sided|||rs6015181||||0.00000741
91564513|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||8.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550116||||0.00000805
91564514|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550115||||0.00000702
91564515|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2082881||||0.00000702
91564516|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||7.43e-06|TWO_SIDED||||||t-test, 2 sided|||exm2265462||||0.00000743
91564517|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||7.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000078
91564518|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||8.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1403069||||0.00000894
91564519|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||5.71e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000571
91564520|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||7.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs8012912||||0.00000729
91564521|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||8.28e-06|TWO_SIDED||||||t-test, 2 sided|||rs11158827||||0.00000828
91564522|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||8.85e-06|TWO_SIDED||||||t-test, 2 sided|||rs11870323||||0.00000885
91564523|NCT01855997|183018060|SUPERIORITY_OR_OTHER|||||||7.17e-06|TWO_SIDED||||||t-test, 2 sided|||rs4821558||||0.00000717
91564524|NCT01855997|183018061|SUPERIORITY_OR_OTHER|||||||6.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000629
91564525|NCT01855997|183018061|SUPERIORITY_OR_OTHER|||||||5.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692421||||0.00000579
91564526|NCT01855997|183018061|SUPERIORITY_OR_OTHER|||||||5.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692423||||0.00000553
91564527|NCT01855997|183018061|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000946
91564528|NCT01855997|183018061|SUPERIORITY_OR_OTHER|||||||4.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000450
91564529|NCT01855997|183018062|SUPERIORITY_OR_OTHER|||||||1.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000118
91564530|NCT01855997|183018062|SUPERIORITY_OR_OTHER|||||||5.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs216312||||0.00000531
91564531|NCT01855997|183018063|SUPERIORITY_OR_OTHER|||||||5.93e-06|TWO_SIDED||||||t-test, 2 sided|||rs993147||||0.00000593
91564532|NCT01855997|183018063|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs10978436||||0.00000997
91564533|NCT01855997|183018063|SUPERIORITY_OR_OTHER|||||||5.81e-06|TWO_SIDED||||||t-test, 2 sided|||rs2370220||||0.00000581
91564534|NCT01855997|183018063|SUPERIORITY_OR_OTHER|||||||8.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2279519||||0.00000802
91564535|NCT01855997|183018064|SUPERIORITY_OR_OTHER|||||||5.58e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000558
91564536|NCT01855997|183018065|SUPERIORITY_OR_OTHER|||||||9.9e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000990
91564537|NCT01855997|183018066|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
91564538|NCT01855997|183018067|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
91564539|NCT01855997|183018068|SUPERIORITY_OR_OTHER|||||||7.38e-06|TWO_SIDED||||||t-test, 2 sided|||rs10814834||||0.00000738
91564540|NCT01855997|183018068|SUPERIORITY_OR_OTHER|||||||4.51e-06|TWO_SIDED||||||t-test, 2 sided|||rs10491723||||0.00000451
91564541|NCT01855997|183018068|SUPERIORITY_OR_OTHER|||||||8.78e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000878
91564542|NCT01855997|183018068|SUPERIORITY_OR_OTHER|||||||5.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16943470||||0.00000521
91564543|NCT01855997|183018069|SUPERIORITY_OR_OTHER|||||||7.2e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000720
91564544|NCT04736472|183018117|SUPERIORITY|||||||0.224|||||||Fisher Exact|||Severe TRAEs||||.224
91564545|NCT04736472|183018117|SUPERIORITY|||||||0.025|||||||Fisher Exact|||Severe TRAEs||||.025
91564546|NCT02268526|183018118|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.891|||||TWO_SIDED|90.0|0.606|1.305||||||||1.305|0.606|
91564547|NCT02268526|183018118|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.941|||||TWO_SIDED|90.0|0.639|1.377||||||||1.377|0.639|
91564548|NCT02332824|183018130|SUPERIORITY_OR_OTHER||LS Mean difference|-0.325|||<|0.0001|TWO_SIDED|95.0|-0.4845|-0.1649||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 5 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.1649|-0.4845|<0.0001
91564549|NCT02332824|183018130|SUPERIORITY_OR_OTHER||LS Mean difference|-0.469|||<|0.0001|TWO_SIDED|95.0|-0.6251|-0.3132||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 20 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3132|-0.6251|<0.0001
91564550|NCT02332824|183018130|SUPERIORITY_OR_OTHER||LS Mean difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.7897|-0.4711||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 40 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4711|-0.7897|<0.0001
91564551|NCT02332824|183018130|SUPERIORITY_OR_OTHER||LS Mean difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.8083|-0.4908||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 80 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4908|-0.8083|<0.0001
91564552|NCT02332824|183018130|SUPERIORITY_OR_OTHER||LS Mean difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.6874|-0.3719||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (Candesartan cilexetil 8 mg -placebo group) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3719|-0.6874|<0.0001
91564553|NCT01052714|183018140|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91564554|NCT01052714|183018141|SUPERIORITY|||||||0.718|||||||Mixed Models Analysis|||||||0.718
91564555|NCT01052714|183018142|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91564556|NCT01052714|183018143|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||||||0.676
91564557|NCT01052714|183018144|SUPERIORITY|||||||0.141|||||||Mixed Models Analysis|||||||0.141
91564558|NCT01052714|183018145|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
91564559|NCT01052714|183018146|SUPERIORITY|||||||0.322|||||||Mixed Models Analysis|||||||0.322
91564560|NCT01052714|183018147|SUPERIORITY|||||||0.652|||||||Mixed Models Analysis|||||||0.652
91564561|NCT01052714|183018148|SUPERIORITY|||||||0.663|||||||Mixed Models Analysis|||||||0.663
91564562|NCT01052714|183018149|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
91564563|NCT01052714|183018150|SUPERIORITY|||||||0.415|||||||Mixed Models Analysis|||||||0.415
91564564|NCT01052714|183018151|SUPERIORITY|||||||0.687|||||||Mixed Models Analysis|||||||0.687
91564565|NCT01052714|183018152|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
91564566|NCT01052714|183018153|SUPERIORITY|||||||0.059|||||||Mixed Models Analysis|||||||0.059
91564567|NCT01052714|183018154|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
91564568|NCT01052714|183018155|SUPERIORITY|||||||0.146|||||||Mixed Models Analysis|||||||0.146
91564569|NCT01052714|183018156|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91564570|NCT01052714|183018157|SUPERIORITY|||||||0.763|||||||Mixed Models Analysis|||||||0.763
91564571|NCT00417989|183018164|NON_INFERIORITY_OR_EQUIVALENCE|Superiority test with margin of 0.35|Mean Difference (Final Values)|0.35|STANDARD_DEVIATION|1.2||0.05|TWO_SIDED|95.0|0.24|0.46||Confidence Interval 95%|ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)||Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.||0.46|0.24|0.05
91564572|NCT00417989|183018166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_DEVIATION|2.0||0.84|TWO_SIDED|95.0|0.64|2.41|||Mantel Haenszel|||||2.41|0.64|0.84
91564573|NCT00417989|183018167|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
91564574|NCT00417989|183018168|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
91564575|NCT00417989|183018169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|16.0|<|0.001||95.0|-9.76|-3.273|||ANCOVA|||||-3.273|-9.760|< 0.001
91564576|NCT00417989|183018171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.75|||||||||Mean difference|||||||
91564577|NCT00417989|183018172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|STANDARD_DEVIATION|25.53|||TWO_SIDED||||||Mean Difference|||||||
91564578|NCT01184755|183018173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.561256|STANDARD_ERROR_OF_MEAN|0.216403||0.01|TWO_SIDED|95.0|-0.987999|-0.134513||This is an intention-to-treat analysis|Mixed effects regression analysis|||This is the change in Systolic BP at 8 weeks||-.134513|-.987999|.01
91564579|NCT01184755|183018173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.391195|STANDARD_ERROR_OF_MEAN|0.140034||0.006|TWO_SIDED|95.0|-0.667312|-0.115079|||mixed effects regression analysis|||This is the analysis of change in diastolic BP from Ambulatory BP monitoring.||-.115079|-.667312|.006
91564580|NCT02951052|183018210|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB - current ART) is not more than 6%.|Adjusted difference in proportion|0.6|||||TWO_SIDED|95.0|-1.2|2.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||2.5|-1.2|
91564581|NCT02951052|183018211|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.|Adjusted difference in proportion|-3.0|||||TWO_SIDED|95.0|-6.7|0.7|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||0.7|-6.7|
91564582|NCT02951052|183018285|OTHER||Adjusted difference|-0.1||||0.944|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||2.2|-2.4|0.944
91564583|NCT02951052|183018285|OTHER||Adjusted difference|1.0||||0.385|TWO_SIDED|95.0|-1.3|3.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||3.4|-1.3|0.385
91564584|NCT02951052|183018286|OTHER||Adjusted difference|4.9|||<|0.001|TWO_SIDED|95.0|2.8|7.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||7.1|2.8|<0.001
91564585|NCT02951052|183018286|OTHER||Adjusted difference|6.4|||<|0.001|TWO_SIDED|95.0|4.0|8.8|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||8.8|4.0|<0.001
91564586|NCT02951052|183018287|OTHER||Adjusted difference|5.3||||0.008|TWO_SIDED|95.0|1.4|9.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||9.1|1.4|0.008
91564587|NCT02951052|183018287|OTHER||Adjusted difference|2.0||||0.347|TWO_SIDED|95.0|-2.2|6.2|||ANCOVA||||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|6.2|-2.2|0.347
91564588|NCT02951052|183018288|OTHER||Adjusted difference|0.2||||0.344|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA||Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||0.7|-0.2|0.344
91564589|NCT02951052|183018288|OTHER||Adjusted difference|-0.1||||0.785|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA||Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||0.4|-0.6|0.785
91564590|NCT02951052|183018288|OTHER||Adjusted difference|0.676||||0.282|TWO_SIDED|95.0|-0.557|1.909|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.909|-0.557|0.282
91564591|NCT02951052|183018288|OTHER||Adjusted difference|0.635||||0.327|TWO_SIDED|95.0|-0.637|1.907|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.907|-0.637|0.327
91564592|NCT02951052|183018288|OTHER||Adjusted difference|0.697||||0.086|TWO_SIDED|95.0|-0.1|1.494|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.494|-0.100|0.086
91564593|NCT02951052|183018288|OTHER||Adjusted difference|0.696||||0.092|TWO_SIDED|95.0|-0.113|1.505|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.505|-0.113|0.092
91564594|NCT02951052|183018291|OTHER||Adjusted difference|7.9|||<|0.001|TWO_SIDED|95.0|4.1|11.7|||ANCOVA||Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.|||11.7|4.1|<0.001
91564595|NCT02951052|183018291|OTHER||Adjusted difference|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.4|||ANCOVA||Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||10.4|3.3|<0.001
91564596|NCT02951052|183018291|OTHER||Adjusted difference|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||14.4|7.1|<0.001
91564597|NCT02924350|183018295|OTHER||Least square (LS) mean difference|-0.924|||<|0.0001|TWO_SIDED|95.0|-1.0547|-0.7927|||ANCOVA|ANCOVA: change from baseline in Schiff sensitivity score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||-0.7927|-1.0547|<.0001
91564598|NCT01589523|183018324|EQUIVALENCE|paired t-test||||||0.342|||||||t-test, 2 sided|||||||0.342
91564599|NCT01589523|183018325|EQUIVALENCE|paired t-test||||||0.116|||||||t-test, 2 sided|||||||0.116
91564600|NCT01589523|183018326|EQUIVALENCE|paired t-test||||||0.065|||||||t-test, 2 sided|vitamin D||||||0.065
91564601|NCT00332488|183018328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.42|TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||0.27|-0.11|0.420
91564602|NCT00332488|183018329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||<|0.001|TWO_SIDED|95.0|0.69|1.14|||ANCOVA|Type III||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||1.14|0.69|< 0.001
91564603|NCT03721978|183018332|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|28.6||||0.115|TWO_SIDED|95.0|-24.6|50.4|||Miettinen and Nurminen method|||||50.4|-24.6|0.115
91564604|NCT03721978|183018337|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|18.9||||0.001|TWO_SIDED|95.0|7.8|28.6|||Miettinen and Nurminen method|||||28.6|7.8|0.001
91564605|NCT03721978|183018338|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
91564606|NCT03721978|183018339|OTHER||Difference in Percentage|12.6|||||TWO_SIDED|95.0|-0.8|24.5||||||||24.5|-0.8|
91564607|NCT03721978|183018340|OTHER||Difference in Percentage|38.1|||||TWO_SIDED|95.0|-15.7|59.5||||||||59.5|-15.7|
91564608|NCT03721978|183018341|OTHER||Difference in Percentage|27.9|||||TWO_SIDED|95.0|16.0|38.2||||||||38.2|16.0|
91564609|NCT03721978|183018342|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
91564610|NCT03721978|183018343|OTHER||Difference in Percentage|17.6|||||TWO_SIDED|95.0|5.2|28.5||||||||28.5|5.2|
91564611|NCT03721978|183018344|OTHER||Difference in Percentage|28.6|||||TWO_SIDED|95.0|-24.6|50.4||||||||50.4|-24.6|
91564612|NCT03721978|183018345|OTHER||Difference in Percentage|20.3|||||TWO_SIDED|95.0|10.1|29.5||||||||29.5|10.1|
91564613|NCT03721978|183018346|OTHER||Difference in Percentage|1.2|||||TWO_SIDED|95.0|-31.2|50.5||||||||50.5|-31.2|
91564614|NCT03721978|183018347|OTHER||Difference in Percentage|5.3|||||TWO_SIDED|95.0|-6.0|17.9||||||||17.9|-6.0|
91564615|NCT03721978|183018348|OTHER||Difference in Percentage|-6.0|||||TWO_SIDED|95.0|-54.7|25.8||||||||25.8|-54.7|
91564616|NCT03721978|183018349|OTHER||Difference in Percentage|12.2|||||TWO_SIDED|95.0|1.1|21.9||||||||21.9|1.1|
91564617|NCT03721978|183018350|OTHER||Location Shift|449.0|||||TWO_SIDED|95.0|0.0|18224.0||||||Week 15: HPV-16 E7||18224.0|0.0|
91564618|NCT03721978|183018350|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|-18224.0|674.0||||||Week 36: HPV-16 E7||674.0|-18224.0|
91564619|NCT03721978|183018350|OTHER||Location Shift|4049.0|||||TWO_SIDED|95.0|224.0|18224.0||||||Week 15: HPV-18 E7||18224.0|224.0|
91564620|NCT03721978|183018350|OTHER||Location Shift|74.0|||||TWO_SIDED|95.0|-18000.0|6074.0||||||Week 36: HPV-18 E7||6074.0|-18000.0|
91564621|NCT03721978|183018351|OTHER||Location Shift|224.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 15: HPV-16 E7||674.0|224.0|
91564622|NCT03721978|183018351|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|0.0|24.0||||||Week 36: HPV-16 E7||24.0|0.0|
91564623|NCT03721978|183018351|OTHER||Location Shift|2024.0|||||TWO_SIDED|95.0|2024.0|6074.0||||||Week 15: HPV-18 E7||6074.0|2024.0|
91564624|NCT03721978|183018351|OTHER||Location Shift|674.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 36: HPV-18 E7||674.0|224.0|
91564625|NCT03721978|183018352|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|0.0|73.33||||||HPV-16 E6: Week 15||73.33|0.00|
91564626|NCT03721978|183018352|OTHER||Location Shift|15.0|||||TWO_SIDED|95.0|0.0|38.33||||||HPV-16 E6: Week 36||38.33|0.00|
91564627|NCT03721978|183018352|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|0.0|85.0||||||HPV-16 E7: Week 15||85.00|0.00|
91564628|NCT03721978|183018352|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|0.0|36.67||||||HPV-16 E7: Week 36||36.67|0.00|
91564629|NCT03721978|183018352|OTHER||Location Shift|26.67|||||TWO_SIDED|95.0|0.0|181.67||||||HPV-18 E6: Week 15||181.67|0.00|
91564630|NCT03721978|183018352|OTHER||Location Shift|11.67|||||TWO_SIDED|95.0|0.0|31.67||||||HPV-18 E6: Week 36||31.67|0.00|
91564631|NCT03721978|183018352|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|0.0|46.67||||||HPV-18 E7: Week 15||46.67|0.00|
91564632|NCT03721978|183018352|OTHER||Location Shift|4.17|||||TWO_SIDED|95.0|0.0|20.0||||||HPV-18 E7: Week 36||20.00|0.00|
91564633|NCT03721978|183018353|OTHER||Location Shift|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 15||11.67|3.33|
91564634|NCT03721978|183018353|OTHER||Location Shift|5.83|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
91564635|NCT03721978|183018353|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|1.67|11.67||||||HPV-16 E7: Week 15||11.67|1.67|
91564636|NCT03721978|183018353|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|5.0||||||HPV-16 E7: Week 36||5.00|0.00|
91564637|NCT03721978|183018353|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|15.0|40.0||||||HPV-18 E6: Week 15||40.00|15.00|
91564638|NCT03721978|183018353|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|10.0|28.33||||||HPV-18 E6: Week 36||28.33|10.00|
91564639|NCT03721978|183018353|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|1.67|6.67||||||HPV-18 E7: Week 15||6.67|1.67|
91564640|NCT03721978|183018353|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|3.33||||||HPV-18 E7: Week 36||3.33|0.00|
91564641|NCT03721978|183018354|OTHER||Location Shift|0.033|||||TWO_SIDED|95.0|-0.004|0.325||||||Parameter: CD8+CD137+Perforin+||0.325|-0.004|
91564642|NCT03721978|183018354|OTHER||Location Shift|0.005|||||TWO_SIDED|95.0|0.0|0.208||||||Parameter: CD8+CD38+Perforin+||0.208|0.000|
91564643|NCT03721978|183018354|OTHER||Location Shift|0.014|||||TWO_SIDED|95.0|-0.055|0.31||||||Parameter: CD8+CD69+Perforin+||0.310|-0.055|
91564644|NCT03721978|183018355|OTHER||Location Shift|0.041|||||TWO_SIDED|95.0|0.004|0.077||||||Parameter: CD8+CD137+Perforin+||0.077|0.004|
91564645|NCT03721978|183018355|OTHER||Location Shift|0.011|||||TWO_SIDED|95.0|0.003|0.028||||||Parameter: CD8+CD38+Perforin+||0.028|0.003|
91564646|NCT03721978|183018355|OTHER||Location Shift|0.034|||||TWO_SIDED|95.0|0.022|0.053||||||Parameter: CD8+CD69+Perforin+||0.053|0.022|
91564647|NCT05244226|183018356|SUPERIORITY|||||||0.045|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.045
91564648|NCT05244226|183018356|SUPERIORITY|||||||0.023|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.023
91564649|NCT05244226|183018360|SUPERIORITY|||||||0.144|||||||Kruskal-Wallis|||||||0.144
91564650|NCT05244226|183018360|SUPERIORITY|||||||0.322|||||||Kruskal-Wallis|||||||0.322
91564651|NCT05244226|183018361|SUPERIORITY|||||||0.061|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.061
91564652|NCT05244226|183018361|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.021
91564653|NCT02675998|183018362|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
91564654|NCT02675998|183018363|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91564655|NCT02675998|183018363|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91564656|NCT02675998|183018363|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
91564657|NCT02552810|183018364|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation, 30 (effect size: 0.5, alpha error: 0.05, power: 0.80).|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91564658|NCT02097849|183018370|SUPERIORITY_OR_OTHER||Difference in proportion|-0.04||||0.692|TWO_SIDED|95.0|-0.27|0.19|||Clopper-Pearson Exact|||||0.19|-0.27|0.692
91564659|NCT02097849|183018371|SUPERIORITY_OR_OTHER||Difference in proportion|-0.19||||0.12|TWO_SIDED|95.0|-0.41|0.05|||Clopper-Pearson Exact|||Responders at Day 28||0.05|-0.41|0.120
91564660|NCT02097849|183018372|SUPERIORITY_OR_OTHER||Difference in proportions|-0.13||||0.225|TWO_SIDED|95.0|-0.35|0.1|||Clopper-Pearson Exact|||||0.10|-0.35|0.225
91564661|NCT02097849|183018373|SUPERIORITY_OR_OTHER||Difference in proportions|-0.22||||0.057|TWO_SIDED|95.0|-0.44|0.01|||Clopper-Pearson Exact|||||0.01|-0.44|0.057
91564662|NCT02097849|183018374|SUPERIORITY_OR_OTHER||Difference in proportions|0.07||||0.3|TWO_SIDED|95.0|-0.16|0.3|||Clopper-Pearson Exact|||||0.30|-0.16|0.300
91564663|NCT02097849|183018375|SUPERIORITY_OR_OTHER||Difference in proportions|-0.03||||0.714|TWO_SIDED|95.0|-0.26|0.2|||Clopper-Pearson Exact|||||0.20|-0.26|0.714
91564664|NCT02097849|183018376|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.967|TWO_SIDED|95.0|-0.24|0.23|||Clopper-Pearson Exact|||||0.23|-0.24|0.967
91564665|NCT02097849|183018377|SUPERIORITY_OR_OTHER||Difference in proportions|-0.01||||0.955|TWO_SIDED|95.0|-0.24|0.22|||Clopper-Pearson Exact|||||0.22|-0.24|0.955
91564666|NCT02561078|183018389|NON_INFERIORITY|The test for the primary objective of noninferiority was performed at the 0.05 significance level using the LS Mean estimate of the difference in change in HbA1c between the 2 treatments at Week 26. Noninferiority was established if the upper limit of a 2-sided 95% confidence interval (CI) for the difference (U 500R CSII minus U 500R MDI) was below the noninferiority margin (NIM) of 0.4%.|Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.62|-0.22|||Mixed Models Analysis|||||-0.22|-0.62|<0.001
91564667|NCT02561078|183018390|SUPERIORITY||Mean Difference (Net)|-35.6|||<|0.001|TWO_SIDED|95.0|-49.4|-21.7|||Mixed Models Analysis|||||-21.7|-49.4|<0.001
91564668|NCT02561078|183018391|SUPERIORITY||Odds Ratio (OR)|1.97||||0.015|TWO_SIDED|95.0|1.14|3.39|||Regression, Logistic|||||3.39|1.14|0.015
91564669|NCT02561078|183018392|SUPERIORITY||Odds Ratio (OR)|1.94||||0.005|TWO_SIDED|95.0|1.23|3.07|||Regression, Logistic|||||3.07|1.23|0.005
91564670|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|-22.5|||<|0.001|TWO_SIDED|95.0|-32.1|-12.8|||Mixed Models Analysis|||Pre Morning Meal||-12.8|-32.1|<0.001
91564671|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|-17.2||||0.008|TWO_SIDED|95.0|-29.9|-4.6|||Mixed Models Analysis|||2 Hours Post Morning Meal||-4.6|-29.9|0.008
91564672|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|-8.9||||0.138|TWO_SIDED|95.0|-20.6|2.9|||Mixed Models Analysis|||Pre Mid-Day Meal||2.9|-20.6|0.138
91564673|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|8.3||||0.16|TWO_SIDED|95.0|-3.3|19.8|||Mixed Models Analysis|||2 Hours Post Mid-Day Meal||19.8|-3.3|0.160
91564674|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|9.1||||0.113|TWO_SIDED|95.0|-2.2|20.4|||Mixed Models Analysis|||Pre Evening Meal||20.4|-2.2|0.113
91564675|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|16.7||||0.004|TWO_SIDED|95.0|5.3|28.2|||Mixed Models Analysis|||2 Hours Post Evening Meal||28.2|5.3|0.004
91564676|NCT02561078|183018393|SUPERIORITY||Mean Difference (Net)|0.6||||0.905|TWO_SIDED|95.0|-9.5|10.8|||Mixed Models Analysis|||Overnight (3:00 AM)||10.8|-9.5|0.905
91564677|NCT02561078|183018394|SUPERIORITY||Mean Difference (Net)|-48.4|||<|0.001|TWO_SIDED|95.0|-74.1|-22.8|||Mixed Models Analysis|||||-22.8|-74.1|<0.001
91564678|NCT02561078|183018395|SUPERIORITY||Odds Ratio (OR)|1.05||||0.919|TWO_SIDED|95.0|0.39|2.86|||Regression, Logistic|||||2.86|0.39|0.919
91564679|NCT02561078|183018396|SUPERIORITY||Relative Rate|1.21||||0.025|TWO_SIDED|95.0|1.02|1.42|||Negative binomial regression|||||1.42|1.02|0.025
91564680|NCT02561078|183018397|SUPERIORITY||Mean Difference (Net)|0.8||||0.1|TWO_SIDED|95.0|-0.2|1.8|||Mixed Models Analysis|||||1.8|-0.2|0.100
91564681|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.87|||<|0.001||95.0|4.59|7.16|||ANCOVA|||||7.16|4.59|<0.001
91564682|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|5.01|7.65|||ANCOVA|||||7.65|5.01|<0.001
91564683|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|||<|0.001||95.0|4.07|6.64|||ANCOVA|||||6.64|4.07|<0.001
91564684|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001||95.0|2.6|5.07|||ANCOVA|||||5.07|2.60|<0.001
91564685|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||<|0.001||95.0|6.13|8.87|||ANCOVA|||||8.87|6.13|<0.001
91564686|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.52|||<|0.001||95.0|4.19|6.85|||ANCOVA|||||6.85|4.19|<0.001
91564687|NCT00043186|183018405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||<|0.001||95.0|3.88|6.55|||ANCOVA|||||6.55|3.88|<0.001
91564688|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564689|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564690|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564691|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564692|NCT00043186|183018406|SUPERIORITY_OR_OTHER|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
91564693|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564694|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564695|NCT00043186|183018406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564696|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564697|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564698|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564699|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564700|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564701|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564702|NCT00043186|183018407|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91564703|NCT00043186|183018407|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564704|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.34|||<|0.001||95.0|5.56|9.12|||ANCOVA|||||9.12|5.56|<0.001
91564705|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.11|||<|0.001||95.0|7.31|10.91|||ANCOVA|||||10.91|7.31|<0.001
91564706|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.56|||<|0.001||95.0|6.71|10.41|||ANCOVA|||||10.41|6.71|<0.001
91564707|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.44|||<|0.001||95.0|6.69|10.19|||ANCOVA|||||10.19|6.69|<0.001
91564708|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|3.43|6.94|||ANCOVA|||||6.94|3.43|<0.001
91564709|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001||95.0|8.14|12.01|||ANCOVA|||||12.01|8.14|<0.001
91564710|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.46|||<|0.001||95.0|6.62|10.3|||ANCOVA|||||10.30|6.62|<0.001
91564711|NCT00043186|183018409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.66|||<|0.001||95.0|6.8|10.53|||ANCOVA|||||10.53|6.80|<0.001
91564712|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|4.32|8.67|||ANCOVA|||||8.67|4.32|<0.001
91564713|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.013||95.0|0.55|4.75|||ANCOVA|||||4.75|0.55|0.013
91564714|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.43|||<|0.001||95.0|10.19|14.68|||ANCOVA|||||14.68|10.19|<0.001
91564715|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|||<|0.001||95.0|8.74|12.94|||ANCOVA|||||12.94|8.74|<0.001
91564716|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|||<|0.001||95.0|7.69|11.89|||ANCOVA|||||11.89|7.69|<0.001
91564717|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.37|6.12|||ANCOVA|||||6.12|1.37|<0.001
91564718|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.97|||<|0.001||95.0|8.63|13.32|||ANCOVA|||||13.32|8.63|<0.001
91564719|NCT00043186|183018410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.37|||<|0.001||95.0|8.16|12.59|||ANCOVA|||||12.59|8.16|<0.001
91564720|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.02||95.0|0.89|9.95|||ANCOVA|||||9.95|0.89|0.02
91564721|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.992||95.0|-5.07|5.02|||ANCOVA|||||5.02|-5.07|0.992
91564722|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9||||0.004||95.0|3.72|14.09|||ANCOVA|||||14.09|3.72|0.004
91564723|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5||||0.001||95.0|4.15|12.86|||ANCOVA|||||12.86|4.15|0.001
91564724|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37||||0.001||95.0|4.11|12.63|||ANCOVA|||||12.63|4.11|0.001
91564725|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98||||0.292||95.0|-1.42|9.37|||ANCOVA|||||9.37|-1.42|0.292
91564726|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.95||||0.004||95.0|3.94|13.96|||ANCOVA|||||13.96|3.94|0.004
91564727|NCT00043186|183018411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.12||||0.094||95.0|0.57|11.67|||ANCOVA|||||11.67|0.57|0.094
91564728|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.93|||<|0.001||95.0|3.97|9.89|||ANCOVA|||||9.89|3.97|<0.001
91564729|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.89|||<|0.001||95.0|1.92|7.85|||ANCOVA|||||7.85|1.92|<0.001
91564730|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.15|||<|0.001||95.0|11.08|17.21|||ANCOVA|||||17.21|11.08|<0.001
91564731|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73|||<|0.001||95.0|9.94|15.52|||ANCOVA|||||15.52|9.94|<0.001
91564732|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.49|||<|0.001||95.0|9.66|15.32|||ANCOVA|||||15.32|9.66|<0.001
91564733|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.42|||<|0.001||95.0|8.12|14.73|||ANCOVA|||||14.73|8.12|<0.001
91564734|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.32|||<|0.001||95.0|9.15|15.49|||ANCOVA|||||15.49|9.15|<0.001
91564735|NCT00043186|183018412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|||<|0.001||95.0|8.72|14.76|||ANCOVA|||||14.76|8.72|<0.001
91564736|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564737|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564738|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564739|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564740|NCT00043186|183018413|SUPERIORITY_OR_OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
91564741|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564742|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564743|NCT00043186|183018413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564744|NCT00043186|183018414|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91564745|NCT00043186|183018414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564746|NCT00043186|183018414|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
91564747|NCT00043186|183018414|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91564748|NCT00043186|183018414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564749|NCT00043186|183018414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564750|NCT00043186|183018414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564751|NCT00043186|183018414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564752|NCT00043186|183018415|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564753|NCT00043186|183018415|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91564754|NCT00043186|183018415|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91564755|NCT00043186|183018415|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91564756|NCT00043186|183018415|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91564757|NCT00043186|183018415|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
91564758|NCT00043186|183018415|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
91564759|NCT00043186|183018415|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564760|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
91564761|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
91564762|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
91564763|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91564764|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91564765|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
91564766|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
91564767|NCT00043186|183018416|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
91564768|NCT00043186|183018417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564769|NCT00043186|183018417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564770|NCT00043186|183018417|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91564771|NCT00043186|183018417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564772|NCT00043186|183018417|SUPERIORITY_OR_OTHER|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
91564773|NCT00043186|183018417|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564774|NCT00043186|183018417|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91564775|NCT00043186|183018417|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91564776|NCT00043186|183018418|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
91564777|NCT00043186|183018418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564778|NCT00043186|183018418|SUPERIORITY_OR_OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
91564779|NCT00043186|183018418|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91564780|NCT00043186|183018418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564781|NCT00043186|183018418|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91564782|NCT00043186|183018418|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91564783|NCT00043186|183018418|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91564784|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
91564785|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
91564786|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
91564787|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
91564788|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
91564789|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
91564790|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91564791|NCT00043186|183018419|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
91564792|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
91564793|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
91564794|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
91564795|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
91564796|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
91564797|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
91564798|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
91564799|NCT00043186|183018420|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
91564800|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001||95.0|1.7|3.64|||ANCOVA|||||3.64|1.70|<0.001
91564801|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.001||95.0|1.9|3.89|||ANCOVA|||||3.89|1.90|<0.001
91564802|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001||95.0|2.07|4.11|||ANCOVA|||||4.11|2.07|<0.001
91564803|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12|||<|0.001||95.0|3.13|5.11|||ANCOVA|||||5.11|3.13|<0.001
91564804|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001||95.0|1.55|3.46|||ANCOVA|||||3.46|1.55|<0.001
91564805|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||<|0.001||95.0|2.83|4.95|||ANCOVA|||||4.95|2.83|<0.001
91564806|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||<|0.001||95.0|1.99|4.04|||ANCOVA|||||4.04|1.99|<0.001
91564807|NCT00043186|183018421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.46|||<|0.001||95.0|2.43|4.48|||ANCOVA|||||4.48|2.43|<0.001
91564808|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|4.04|6.34|||ANCOVA|||||6.34|4.04|<0.001
91564809|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|||<|0.001||95.0|4.93|7.27|||ANCOVA|||||7.27|4.93|<0.001
91564810|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|||<|0.001||95.0|4.4|6.78|||ANCOVA|||||6.78|4.40|<0.001
91564811|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.89|||<|0.001||95.0|5.76|8.01|||ANCOVA|||||8.01|5.76|<0.001
91564812|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|||<|0.001||95.0|3.41|5.67|||ANCOVA|||||5.67|3.41|<0.001
91564813|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95|||<|0.001||95.0|5.69|8.21|||ANCOVA|||||8.21|5.69|<0.001
91564814|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|||<|0.001||95.0|4.29|6.67|||ANCOVA|||||6.67|4.29|<0.001
91564815|NCT00043186|183018422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|4.76|7.17|||ANCOVA|||||7.17|4.76|<0.001
91564816|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.78|||<|0.001||95.0|2.19|5.36|||ANCOVA|||||5.36|2.19|<0.001
91564817|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41||||0.07||95.0|-0.12|2.94|||ANCOVA|||||2.94|-0.12|0.07
91564818|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.17|||<|0.001||95.0|5.54|8.8|||ANCOVA|||||8.80|5.54|<0.001
91564819|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|||<|0.001||95.0|7.13|10.21|||ANCOVA|||||10.21|7.13|<0.001
91564820|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.15|||<|0.001||95.0|5.62|8.69|||ANCOVA|||||8.69|5.62|<0.001
91564821|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.07||95.0|-0.12|3.35|||ANCOVA|||||3.35|-0.12|0.07
91564822|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.26|||<|0.001||95.0|5.56|8.95|||ANCOVA|||||8.95|5.56|<0.001
91564823|NCT00043186|183018423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63|||<|0.001||95.0|6.02|9.24|||ANCOVA|||||9.24|6.02|<0.001
91564824|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94||||0.002||95.0|1.86|8.02|||ANCOVA|||||8.02|1.86|0.002
91564825|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.677||95.0|-4.1|2.68|||ANCOVA|||||2.68|-4.10|0.677
91564826|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.66||||0.001||95.0|3.14|10.18|||ANCOVA|||||10.18|3.14|0.001
91564827|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.29|||<|0.001||95.0|5.26|11.33|||ANCOVA|||||11.33|5.26|<0.001
91564828|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|3.59|9.41|||ANCOVA|||||9.41|3.59|<0.001
91564829|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.047||95.0|0.61|8.05|||ANCOVA|||||8.05|0.61|0.047
91564830|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.94||||0.003||95.0|2.53|9.36|||ANCOVA|||||9.36|2.53|0.003
91564831|NCT00043186|183018424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.97||||0.001||95.0|3.28|10.66|||ANCOVA|||||10.66|3.28|0.001
91564832|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.69|||<|0.001||95.0|2.97|6.41|||ANCOVA|||||6.41|2.97|<0.001
91564833|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.015||95.0|0.43|3.89|||ANCOVA|||||3.89|0.43|0.015
91564834|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.52|||<|0.001||95.0|6.74|10.3|||ANCOVA|||||10.30|6.74|<0.001
91564835|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58|||<|0.001||95.0|7.95|11.21|||ANCOVA|||||11.21|7.95|<0.001
91564836|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.34|||<|0.001||95.0|6.7|9.99|||ANCOVA|||||9.99|6.70|<0.001
91564837|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38|||<|0.001||95.0|5.45|9.31|||ANCOVA|||||9.31|5.45|<0.001
91564838|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.55|||<|0.001||95.0|5.72|9.38|||ANCOVA|||||9.38|5.72|<0.001
91564839|NCT00043186|183018425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.97|||<|0.001||95.0|7.23|10.72|||ANCOVA|||||10.72|7.23|<0.001
91564840|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.033||95.0|0.11|2.76|||ANCOVA|||||2.76|0.11|0.033
91564841|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|||<|0.001||95.0|1.69|4.42|||ANCOVA|||||4.42|1.69|<0.001
91564842|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.04|||<|0.001||95.0|1.68|4.4|||ANCOVA|||||4.40|1.68|<0.001
91564843|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001||95.0|1.94|4.57|||ANCOVA|||||4.57|1.94|<0.001
91564844|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.91|||<|0.001||95.0|1.6|4.21|||ANCOVA|||||4.21|1.60|<0.001
91564845|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07|||<|0.001||95.0|1.65|4.49|||ANCOVA|||||4.49|1.65|<0.001
91564846|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001||95.0|0.99|3.76|||ANCOVA|||||3.76|0.99|<0.001
91564847|NCT00043186|183018426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.001||95.0|1.47|4.24|||ANCOVA|||||4.24|1.47|<0.001
91564848|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99||||0.009||95.0|0.49|3.49|||ANCOVA|||||3.49|0.49|0.009
91564849|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.58|||<|0.001||95.0|2.06|5.1|||ANCOVA|||||5.10|2.06|<0.001
91564850|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.001||95.0|2.73|5.78|||ANCOVA|||||5.78|2.73|<0.001
91564851|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001||95.0|2.55|5.62|||ANCOVA|||||5.62|2.55|<0.001
91564852|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||<|0.001||95.0|3.23|6.11|||ANCOVA|||||6.11|3.23|<0.001
91564853|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||<|0.001||95.0|3.78|6.73|||ANCOVA|||||6.73|3.78|<0.001
91564854|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001||95.0|2.48|5.68|||ANCOVA|||||5.68|2.48|<0.001
91564855|NCT00043186|183018427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|||<|0.001||95.0|1.86|4.93|||ANCOVA|||||4.93|1.86|<0.001
91564856|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69||||0.002||95.0|1.01|4.38|||ANCOVA|||||4.38|1.01|0.002
91564857|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77|||<|0.001||95.0|2.14|5.39|||ANCOVA|||||5.39|2.14|<0.001
91564858|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||<|0.001||95.0|3.87|7.26|||ANCOVA|||||7.26|3.87|<0.001
91564859|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|4.75|7.92|||ANCOVA|||||7.92|4.75|<0.001
91564860|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73|||<|0.001||95.0|4.12|7.33|||ANCOVA|||||7.33|4.12|<0.001
91564861|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.89|6.5|||ANCOVA|||||6.50|2.89|<0.001
91564862|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.92|6.49|||ANCOVA|||||6.49|2.92|<0.001
91564863|NCT00043186|183018428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|||<|0.001||95.0|3.96|7.3|||ANCOVA|||||7.30|3.96|<0.001
91564864|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||0.496||95.0|-7.16|13.7|||ANCOVA|||||13.7|-7.16|0.496
91564865|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6||||0.527||95.0|-6.38|19.59|||ANCOVA|||||19.59|-6.38|0.527
91564866|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72||||0.503||95.0|-2.9|14.33|||ANCOVA|||||14.33|-2.90|0.503
91564867|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||0.527||95.0|-6.54|11.89|||ANCOVA|||||11.89|-6.54|0.527
91564868|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41||||0.503||95.0|-2.19|17.01|||ANCOVA|||||17.01|-2.19|0.503
91564869|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.59||||0.503||95.0|-1.85|17.03|||ANCOVA|||||17.03|-1.85|0.503
91564870|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.18||||0.503||95.0|-2.45|16.81|||ANCOVA|||||16.81|-2.45|0.503
91564871|NCT00043186|183018429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.233||95.0|0.78|14.97|||ANCOVA|||||14.97|0.78|0.233
91564872|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.41|||<|0.001||95.0|4.48|8.34|||ANCOVA|||||8.34|4.48|<0.001
91564873|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44|||<|0.001||95.0|4.19|8.7|||ANCOVA|||||8.70|4.19|<0.001
91564874|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|3.91|8.26|||ANCOVA|||||8.26|3.91|<0.001
91564875|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|||<|0.001||95.0|3.7|7.73|||ANCOVA|||||7.73|3.70|<0.001
91564876|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.054||95.0|-0.04|4.04|||ANCOVA|||||4.04|-0.04|0.054
91564877|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.71|5.77|||ANCOVA|||||5.77|1.71|<0.001
91564878|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.05|||<|0.001||95.0|4.0|8.1|||ANCOVA|||||8.10|4.00|<0.001
91564879|NCT00043186|183018430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39|||<|0.001||95.0|4.49|8.28|||ANCOVA|||||8.28|4.49|<0.001
91564880|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.001||95.0|1.09|3.51|||ANCOVA|||||3.51|1.09|0.001
91564881|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73||||0.005||95.0|0.52|2.93|||ANCOVA|||||2.93|0.52|0.005
91564882|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.004||95.0|0.74|3.25|||ANCOVA|||||3.25|0.74|0.004
91564883|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001||95.0|1.54|3.91|||ANCOVA|||||3.91|1.54|<0.001
91564884|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.202||95.0|-0.41|1.95|||ANCOVA|||||1.95|-0.41|0.202
91564885|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95|||<|0.001||95.0|1.65|4.26|||ANCOVA|||||4.26|1.65|<0.001
91564886|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.004||95.0|0.78|3.26|||ANCOVA|||||3.26|0.78|0.004
91564887|NCT00043186|183018431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.004||95.0|0.8|3.27|||ANCOVA|||||3.27|0.80|0.004
91564888|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.14|||<|0.001||95.0|1.71|4.56|||ANCOVA|||||4.56|1.71|<0.001
91564889|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|||<|0.001||95.0|2.95|5.84|||ANCOVA|||||5.84|2.95|<0.001
91564890|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.64|||<|0.001||95.0|3.19|6.09|||ANCOVA|||||6.09|3.19|<0.001
91564891|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|||<|0.001||95.0|2.85|5.58|||ANCOVA|||||5.58|2.85|<0.001
91564892|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.53|||<|0.001||95.0|1.13|3.94|||ANCOVA|||||3.94|1.13|<0.001
91564893|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|4.53|7.64|||ANCOVA|||||7.64|4.53|<0.001
91564894|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.55|||<|0.001||95.0|3.12|5.98|||ANCOVA|||||5.98|3.12|<0.001
91564895|NCT00043186|183018432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|||<|0.001||95.0|2.76|5.69|||ANCOVA|||||5.69|2.76|<0.001
91564896|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|||<|0.001||95.0|3.63|8.68|||ANCOVA|||||8.68|3.63|<0.001
91564897|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.275||95.0|-1.06|3.7|||ANCOVA|||||3.7|-1.06|0.275
91564898|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.005||95.0|1.65|6.75|||ANCOVA|||||6.75|1.65|0.005
91564899|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.41||||0.002||95.0|2.07|6.75|||ANCOVA|||||6.75|2.07|0.002
91564900|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.009||95.0|1.25|6.05|||ANCOVA|||||6.05|1.25|0.009
91564901|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95||||0.009||95.0|1.22|6.68|||ANCOVA|||||6.68|1.22|0.009
91564902|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.003||95.0|2.05|7.24|||ANCOVA|||||7.24|2.05|0.003
91564903|NCT00043186|183018433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.001||95.0|2.28|7.22|||ANCOVA|||||7.22|2.28|0.001
91564904|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.18||||0.949||95.0|-8.73|13.1|||ANCOVA|||||13.10|-8.73|0.949
91564905|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.949||95.0|-2.7|9.31|||ANCOVA|||||9.31|-2.70|0.949
91564906|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.709||95.0|-6.81|9.29|||ANCOVA|||||9.29|-6.81|0.709
91564907|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.949||95.0|-8.55|3.83|||ANCOVA|||||3.83|-8.55|0.949
91564908|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.949||95.0|-4.51|8.72|||ANCOVA|||||8.72|-4.51|0.949
91564909|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.23||||0.484||95.0|-0.83|15.3|||ANCOVA|||||15.3|-0.83|0.484
91564910|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.949||95.0|-3.77|8.66|||ANCOVA|||||8.66|-3.77|0.949
91564911|NCT00043186|183018434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.949||95.0|-10.82|11.4|||ANCOVA|||||11.40|-10.82|0.949
91564912|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.02|||<|0.001||95.0|4.35|9.69|||ANCOVA|||||9.69|4.35|<0.001
91564913|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.092||95.0|-0.37|4.87|||ANCOVA|||||4.87|-0.37|0.092
91564914|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.5|8.94|||ANCOVA|||||8.94|3.50|<0.001
91564915|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|3.51|8.43|||ANCOVA|||||8.43|3.51|<0.001
91564916|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|||<|0.001||95.0|3.44|8.48|||ANCOVA|||||8.48|3.44|<0.001
91564917|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.29|||<|0.001||95.0|3.25|9.34|||ANCOVA|||||9.34|3.25|<0.001
91564918|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001||95.0|3.13|8.7|||ANCOVA|||||8.70|3.13|<0.001
91564919|NCT00043186|183018435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.58|8.87|||ANCOVA|||||8.87|3.58|<0.001
91564920|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564921|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564922|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564923|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564924|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564925|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564926|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564927|NCT00043186|183018436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564928|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564929|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564930|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564931|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564932|NCT00043186|183018437|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91564933|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564934|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564935|NCT00043186|183018437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564936|NCT00043186|183018438|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
91564937|NCT00043186|183018438|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91564938|NCT00043186|183018438|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564939|NCT00043186|183018438|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564940|NCT00043186|183018438|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564941|NCT00043186|183018438|SUPERIORITY_OR_OTHER|||||||0.146|||||||Wilcoxon (Mann-Whitney)|||||||0.146
91564942|NCT00043186|183018438|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91564943|NCT00043186|183018438|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564944|NCT00043186|183018439|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
91564945|NCT00043186|183018439|SUPERIORITY_OR_OTHER|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
91564946|NCT00043186|183018439|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91564947|NCT00043186|183018439|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564948|NCT00043186|183018439|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564949|NCT00043186|183018439|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91564950|NCT00043186|183018439|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91564951|NCT00043186|183018439|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
91564952|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
91564953|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.218|||||||Wilcoxon (Mann-Whitney)|||||||0.218
91564954|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
91564955|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
91564956|NCT00043186|183018440|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91564957|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
91564958|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91564959|NCT00043186|183018440|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91564960|NCT04050722|183018455|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.08|-0.04||Analysis was performed using ANCOVA model with study product group, gender, and baseline MGI stratification (low/high) as factors and the baseline value as covariate.|ANCOVA|||||-0.04|-0.08|<0.0001
91564961|NCT02469077|183018480|SUPERIORITY|||||||0.12|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.12
91564962|NCT02469077|183018481|SUPERIORITY|||||||0.04|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.04
91564963|NCT02469077|183018482|SUPERIORITY|||||||0.03|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.03
91564964|NCT02469077|183018483|SUPERIORITY|||||||0.17|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.17
91564965|NCT02469077|183018484|SUPERIORITY|||||||0.13|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.13
91564966|NCT02469077|183018485|SUPERIORITY|||||||0.98|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.98
91564967|NCT02469077|183018486|SUPERIORITY|||||||0.52|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.52
91564968|NCT02469077|183018487|SUPERIORITY|||||||0.65|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.65
91564969|NCT02469077|183018488|SUPERIORITY|||||||0.1|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.1
91564970|NCT02469077|183018489|SUPERIORITY|||||||0.046|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.046
91564971|NCT02469077|183018490|SUPERIORITY|||||||0.61|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.61
91564972|NCT02469077|183018491|SUPERIORITY|||||||0.4|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.4
91564973|NCT02469077|183018492|SUPERIORITY|||||||0.57|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.57
91564974|NCT02973477|183018493|OTHER|Mixed effects model|Coefficient|0.28||||0.28|TWO_SIDED|95.0|-0.24|0.8||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted mixed models analysis for both periods, both arms, comparing each treatment's change.||0.8|-0.24|0.28
91564975|NCT02973477|183018494|OTHER||Coefficient|-0.003||||0.97|TWO_SIDED|95.0|-0.16|0.15||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for SDNN.||0.15|-0.16|0.97
91564976|NCT02973477|183018494|OTHER||Coefficient|-0.02||||0.79|TWO_SIDED|95.0|-0.21|0.16||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for rmsSD.||0.16|-0.21|0.79
91564977|NCT02973477|183018495|OTHER||Coefficient|0.01||||0.58|TWO_SIDED|95.0|-0.02|0.04||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of EI ratio.||0.04|-0.02|0.58
91564978|NCT02973477|183018495|OTHER||Coefficient|0.02||||0.58|TWO_SIDED|95.0|-0.05|0.09||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for Valsalva ratio.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis for both periods, both arms, comparing each treatment's change of Valsalva ratio.||0.09|-0.05|0.58
91564979|NCT02973477|183018495|OTHER||Coefficient|-0.01||||0.56|TWO_SIDED|95.0|-0.05|0.03||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for 30:15 ratio.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of 30:15 ratio.||0.03|-0.05|0.56
91564980|NCT02973477|183018496|OTHER||Coefficient|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of BNP.||0.25|-0.23|0.92
91564981|NCT02720081|183018499|SUPERIORITY||Difference in least squares means|-4.775||||0.352|TWO_SIDED|95.0|-14.92|5.37|||ANOVA|Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||5.370|-14.92|0.352
91564982|NCT02720081|183018500|OTHER||Difference in percentages|-0.4|||||TWO_SIDED|95.0|-15.0|14.3|||||Based on Miettinen \& Nurminen|||14.3|-15.0|
91564983|NCT02720081|183018501|OTHER||Difference in percentages|-4.3|||||TWO_SIDED|95.0|-12.1|1.0|||||Based on Miettinen \& Nurminen|||1.0|-12.1|
91564984|NCT02720081|183018523|SUPERIORITY||Difference in least squares means|0.107||||0.023|TWO_SIDED|95.0|0.015|0.199|||Constrained longitudinal data analysis|Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||0.199|0.015|0.023
91564985|NCT03334747|183018529|OTHER|||||||0.391|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||0.391
91564986|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564987|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564988|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564989|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564990|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564991|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564992|NCT03334747|183018529|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
91564993|NCT03303521|183018543|SUPERIORITY||Odds Ratio (OR)|68.77|||<|0.001|TWO_SIDED|95.0|10.85|2810.85|||Fisher Exact|||||2810.85|10.85|<0.001
91564994|NCT03303521|183018545|SUPERIORITY||Odds Ratio (OR)|35.51|||<|0.001|TWO_SIDED|95.0|8.53|309.48|||Fisher Exact|||||309.48|8.53|<0.001
91564995|NCT04086576|183018560|SUPERIORITY||||||<|0.0001||||||Yes, used Tukey Kramer pairwise comparisons to adjust for multiple comparisons|ANOVA|ANOVA in repeated measures||Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).||||<.0001
91564996|NCT04748445|183018566|OTHER||Slope|0.065|||<|0.0001|TWO_SIDED|90.0|0.046|0.083|||Mixed Models Analysis|||Chills||0.083|0.046|<.0001
91564997|NCT04748445|183018566|OTHER||Slope|0.281|||<|0.0001|TWO_SIDED|90.0|0.221|0.341|||Mixed Models Analysis|||Cough||0.341|0.221|<.0001
91564998|NCT04748445|183018566|OTHER||Slope|0.036|||<|0.0001|TWO_SIDED|90.0|0.023|0.048|||Mixed Models Analysis|||Diarrhea||0.048|0.023|<.0001
91564999|NCT04748445|183018566|OTHER||Slope|0.113|||<|0.0001|TWO_SIDED|90.0|0.069|0.156|||Mixed Models Analysis|||Difficulty breathing||0.156|0.069|<.0001
91565000|NCT04748445|183018566|OTHER||Slope|0.259|||<|0.0001|TWO_SIDED|90.0|0.206|0.312|||Mixed Models Analysis|||Fatigue||0.312|0.206|<.0001
91565001|NCT04748445|183018566|OTHER||Slope|0.029|||<|0.0001|TWO_SIDED|90.0|0.02|0.037|||Mixed Models Analysis|||Fever||0.037|0.020|<.0001
91565002|NCT04748445|183018566|OTHER||Slope|0.194|||<|0.0001|TWO_SIDED|90.0|0.148|0.241|||Mixed Models Analysis|||Headache||0.241|0.148|<.0001
91565003|NCT04748445|183018566|OTHER||Slope|0.103||||0.0002|TWO_SIDED|90.0|0.059|0.148|||Mixed Models Analysis|||Loss of taste or smell||0.148|0.059|0.0002
91565004|NCT04748445|183018566|OTHER||Slope|0.181|||<|0.0001|TWO_SIDED|90.0|0.137|0.226|||Mixed Models Analysis|||Muscle pain||0.226|0.137|<.0001
91565005|NCT04748445|183018566|OTHER||Slope|0.044|||<|0.0001|TWO_SIDED|90.0|0.028|0.06|||Mixed Models Analysis|||Nausea||0.060|0.028|<.0001
91565006|NCT04748445|183018566|OTHER||Slope|0.03||||0.0007|TWO_SIDED|90.0|0.016|0.044|||Mixed Models Analysis|||Rigors||0.044|0.016|0.0007
91565007|NCT04748445|183018566|OTHER||Slope|0.159|||<|0.0001|TWO_SIDED|90.0|0.123|0.195|||Mixed Models Analysis|||Runny nose||0.195|0.123|<.0001
91565008|NCT04748445|183018566|OTHER||Slope|0.222|||<|0.0001|TWO_SIDED|90.0|0.168|0.277|||Mixed Models Analysis|||Sore throat||0.277|0.168|<.0001
91565009|NCT04748445|183018566|OTHER||Slope|0.337|||<|0.0001|TWO_SIDED|90.0|0.264|0.411|||Mixed Models Analysis|||Stuffy/blocked nose||0.411|0.264|<.0001
91565010|NCT04748445|183018566|OTHER||Slope|0.005||||0.0053|TWO_SIDED|90.0|0.002|0.007|||Mixed Models Analysis|||Vomiting||0.007|0.002|0.0053
91565011|NCT04748445|183018566|OTHER||Slope|0.049||||0.0057|TWO_SIDED|90.0|0.02|0.078|||Mixed Models Analysis|||Wheezing||0.078|0.020|0.0057
91565012|NCT04748445|183018566|OTHER||Slope|2.644|||<|0.0001|TWO_SIDED|90.0|2.101|3.188|||Mixed Models Analysis|||Mean of daily total symptom score||3.188|2.101|<.0001
91565013|NCT04748445|183018567|OTHER||Slope|-1.519|STANDARD_ERROR_OF_MEAN|2.769|<|0.0001|TWO_SIDED|90.0|-1.978|-1.06|||Mixed Models Analysis|||AHH\_Max Phonation Time (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.060|-1.978|<.0001
91565014|NCT04748445|183018567|OTHER||Slope|6.899|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||EE\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-8).||||<.0001
91565015|NCT04748445|183018567|OTHER||Slope|-1.743|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||MM\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-7).||||<.0001
91565016|NCT04748445|183018568|OTHER||Slope|-1.326|STANDARD_ERROR_OF_MEAN|1.174||0.9103|TWO_SIDED|90.0|-2.079|1.814|||Mixed Models Analysis|||EE\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||1.814|-2.079|0.9103
91565017|NCT04748445|183018568|OTHER||Slope|0.007667|STANDARD_ERROR_OF_MEAN|1.741||0.6605|TWO_SIDED|90.0|-0.02119|0.03653|||Mixed Models Analysis|||EE\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03653|-0.02119|0.6605
91565018|NCT04748445|183018568|OTHER||Slope|1.268|STANDARD_ERROR_OF_MEAN|2.82|<|0.0001|TWO_SIDED|90.0|0.8012|1.736|||Mixed Models Analysis|||EE\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.736|0.8012|<.0001
91565019|NCT04748445|183018568|OTHER||Slope|-1.752|STANDARD_ERROR_OF_MEAN|2.127||0.4117|TWO_SIDED|90.0|-5.276|1.773|||Mixed Models Analysis|||EE\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-1).||1.773|-5.276|0.4117
91565020|NCT04748445|183018568|OTHER||Slope|1.39|STANDARD_ERROR_OF_MEAN|1.262||0.2728|TWO_SIDED|90.0|-7.012|3.482|||Mixed Models Analysis|||EE\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.482|-7.012|0.2728
91565021|NCT04748445|183018568|OTHER||Slope|-1.407|STANDARD_ERROR_OF_MEAN|1.194||0.2411|TWO_SIDED|90.0|-3.385|5.724|||Mixed Models Analysis|||EE\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||5.724|-3.385|0.2411
91565022|NCT04748445|183018568|OTHER||Slope|-0.004466|STANDARD_ERROR_OF_MEAN|8.869||0.9599|TWO_SIDED|90.0|-0.1514|0.1425|||Mixed Models Analysis|||EE\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1425|-0.1514|0.9599
91565023|NCT04748445|183018568|OTHER||Slope|-0.1572|STANDARD_ERROR_OF_MEAN|9.127||0.0875|TWO_SIDED|90.0|-0.3084|-0.005942|||Mixed Models Analysis|||EE\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.005942|-0.3084|0.0875
91565024|NCT04748445|183018568|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|7.598||0.1029|TWO_SIDED|90.0|-1.072|2.507|||Mixed Models Analysis|||EE\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2 and for lower limit it was 10\^-3).||2.507|-1.072|0.1029
91565025|NCT04748445|183018568|OTHER||Slope|-1.054|STANDARD_ERROR_OF_MEAN|7.218||0.1468|TWO_SIDED|90.0|-2.25|1.423|||Mixed Models Analysis|||EE\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-1. For upper limit and dispersion value it was 10\^-2).||1.423|-2.250|0.1468
91565026|NCT04748445|183018568|OTHER||Slope|0.05944|STANDARD_ERROR_OF_MEAN|6.536||0.3649|TWO_SIDED|90.0|-0.04887|0.1678|||Mixed Models Analysis|||EE\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1678|-0.04887|0.3649
91565027|NCT04748445|183018568|OTHER||Slope|-0.03115|STANDARD_ERROR_OF_MEAN|6.007||0.605|TWO_SIDED|90.0|-0.1307|0.06839|||Mixed Models Analysis|||EE\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06839|-0.1307|0.6050
91565028|NCT04748445|183018568|OTHER||Slope|-0.01908|STANDARD_ERROR_OF_MEAN|5.932||0.7483|TWO_SIDED|90.0|-0.1174|0.07922|||Mixed Models Analysis|||EE\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.07922|-0.1174|0.7483
91565029|NCT04748445|183018568|OTHER||Slope|-6.574|STANDARD_ERROR_OF_MEAN|5.105||0.9897|TWO_SIDED|90.0|-8.526|8.394|||Mixed Models Analysis|||EE\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-4).||8.394|-8.526|0.9897
91565030|NCT04748445|183018568|OTHER||Slope|5.026|STANDARD_ERROR_OF_MEAN|5.176||0.9228|TWO_SIDED|90.0|-8.074|9.08|||Mixed Models Analysis|||EE\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||9.080|-8.074|0.9228
91565031|NCT04748445|183018568|OTHER||Slope|0.08365|STANDARD_ERROR_OF_MEAN|2.873||0.0043|TWO_SIDED|90.0|0.03604|0.1313|||Mixed Models Analysis|||EE\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1313|0.03604|0.0043
91565032|NCT04748445|183018568|OTHER||Slope|0.02906|STANDARD_ERROR_OF_MEAN|1.181||0.0153|TWO_SIDED|90.0|0.009486|0.04863|||Mixed Models Analysis|||EE\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.04863|0.009486|0.0153
91565033|NCT04748445|183018568|OTHER||Slope|3.96|STANDARD_ERROR_OF_MEAN|1.447||0.0071|TWO_SIDED|90.0|1.563|6.357|||Mixed Models Analysis|||EE\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.357|1.563|0.0071
91565034|NCT04748445|183018568|OTHER||Slope|2.816|STANDARD_ERROR_OF_MEAN|1.026||0.007|TWO_SIDED|90.0|1.115|4.516|||Mixed Models Analysis|||EE\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.516|1.115|0.0070
91565035|NCT04748445|183018568|OTHER||Slope|0.007814|STANDARD_ERROR_OF_MEAN|1.034||0.4513|TWO_SIDED|90.0|-0.009323|0.02495|||Mixed Models Analysis|||EE\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02495|-0.009323|0.4513
91565036|NCT04748445|183018568|OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|8.443||0.1753|TWO_SIDED|90.0|-2.483|2.55|||Mixed Models Analysis|||EE\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.550|-2.483|0.1753
91565037|NCT04748445|183018568|OTHER||Slope|2.528|STANDARD_ERROR_OF_MEAN|8.228||0.0026|TWO_SIDED|90.0|1.164|3.891|||Mixed Models Analysis|||EE\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion it was 10\^-3).||3.891|1.164|0.0026
91565038|NCT04748445|183018568|OTHER||Slope|0.01755|STANDARD_ERROR_OF_MEAN|7.204||0.0162|TWO_SIDED|90.0|0.005616|0.02949|||Mixed Models Analysis|||EE\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02949|0.005616|0.0162
91565039|NCT04748445|183018568|OTHER||Slope|2.673|STANDARD_ERROR_OF_MEAN|5.892|<|0.0001|TWO_SIDED|90.0|1.697|3.65|||Mixed Models Analysis|||EE\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.650|1.697|<.0001
91565040|NCT04748445|183018568|OTHER||Slope|0.01394|STANDARD_ERROR_OF_MEAN|5.642||0.0148|TWO_SIDED|90.0|0.004595|0.02329|||Mixed Models Analysis|||EE\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02329|0.004595|0.0148
91565041|NCT04748445|183018568|OTHER||Slope|0.01547|STANDARD_ERROR_OF_MEAN|6.666||0.0219|TWO_SIDED|90.0|0.004425|0.02652|||Mixed Models Analysis|||EE\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02652|0.004425|0.0219
91565042|NCT04748445|183018568|OTHER||Slope|1.118|STANDARD_ERROR_OF_MEAN|6.122||0.0703|TWO_SIDED|90.0|1.032|2.132|||Mixed Models Analysis|||EE\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.132|1.032|0.0703
91565043|NCT04748445|183018568|OTHER||Slope|0.0116|STANDARD_ERROR_OF_MEAN|5.226||0.0282|TWO_SIDED|90.0|0.00294|0.02026|||Mixed Models Analysis|||EE\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02026|0.002940|0.0282
91565044|NCT04748445|183018568|OTHER||Slope|0.04771|STANDARD_ERROR_OF_MEAN|3.351||0.157|TWO_SIDED|90.0|-0.007823|0.1032|||Mixed Models Analysis|||EE\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1032|-0.007823|0.1570
91565045|NCT04748445|183018568|OTHER||Slope|0.0008053|STANDARD_ERROR_OF_MEAN|9.807||0.4131|TWO_SIDED|90.0|-0.0008199|0.002431|||Mixed Models Analysis|||EE\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002431|-0.0008199|0.4131
91565046|NCT04748445|183018568|OTHER||Slope|-0.03945|STANDARD_ERROR_OF_MEAN|1.892||0.0391|TWO_SIDED|90.0|-0.0708|-0.008096|||Mixed Models Analysis|||EE\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008096|-0.07080|0.0391
91565047|NCT04748445|183018568|OTHER||Slope|-0.07075|STANDARD_ERROR_OF_MEAN|8.409||0.4018|TWO_SIDED|90.0|-0.2101|0.0686|||Mixed Models Analysis|||EE\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06860|-0.2101|0.4018
91565048|NCT04748445|183018568|OTHER||Slope|1.658|STANDARD_ERROR_OF_MEAN|3.607||0.6466|TWO_SIDED|90.0|-4.319|7.635|||Mixed Models Analysis|||EE\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.635|-4.319|0.6466
91565049|NCT04748445|183018568|OTHER||Slope|1.172|STANDARD_ERROR_OF_MEAN|1.423||0.4118|TWO_SIDED|90.0|-1.186|3.53|||Mixed Models Analysis|||MM\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||3.530|-1.186|0.4118
91565050|NCT04748445|183018568|OTHER||Slope|-1.282|STANDARD_ERROR_OF_MEAN|1.965||0.9481|TWO_SIDED|90.0|-3.385|3.129|||Mixed Models Analysis|||MM\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||3.129|-3.385|0.9481
91565051|NCT04748445|183018568|OTHER||Slope|0.9159|STANDARD_ERROR_OF_MEAN|2.641||0.0007|TWO_SIDED|90.0|0.4783|1.354|||Mixed Models Analysis|||MM\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.354|0.4783|0.0007
91565052|NCT04748445|183018568|OTHER||Slope|-2.18|STANDARD_ERROR_OF_MEAN|1.894||0.2519|TWO_SIDED|90.0|-5.319|9.585|||Mixed Models Analysis|||MM\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||9.585|-5.319|0.2519
91565053|NCT04748445|183018568|OTHER||Slope|1.821|STANDARD_ERROR_OF_MEAN|1.028||0.0791|TWO_SIDED|90.0|1.166|3.524|||Mixed Models Analysis|||MM\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.524|1.166|0.0791
91565054|NCT04748445|183018568|OTHER||Slope|-0.2064|STANDARD_ERROR_OF_MEAN|8.474||0.0163|TWO_SIDED|90.0|-0.3468|-0.06599|||Mixed Models Analysis|||MM\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.06599|-0.3468|0.0163
91565055|NCT04748445|183018568|OTHER||Slope|-1.265|STANDARD_ERROR_OF_MEAN|9.67||0.1932|TWO_SIDED|90.0|-2.867|3.375|||Mixed Models Analysis|||MM\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and dispersion value it was 10\^-2. For lower limit and estimated value it was 10\^-1).||3.375|-2.867|0.1932
91565056|NCT04748445|183018568|OTHER||Slope|0.02851|STANDARD_ERROR_OF_MEAN|9.96||0.7752|TWO_SIDED|90.0|-0.1365|0.1936|||Mixed Models Analysis|||MM\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1936|-0.1365|0.7752
91565057|NCT04748445|183018568|OTHER||Slope|1.209|STANDARD_ERROR_OF_MEAN|7.569||0.1126|TWO_SIDED|90.0|-4.48|2.464|||Mixed Models Analysis|||MM\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For lower limit it was 10\^-3. For dispersion value it was 10\^-2).||2.464|-4.480|0.1126
91565058|NCT04748445|183018568|OTHER||Slope|-0.2215|STANDARD_ERROR_OF_MEAN|8.498||0.0102|TWO_SIDED|90.0|-0.3624|-0.08072|||Mixed Models Analysis|||MM\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.08072|-0.3624|0.0102
91565059|NCT04748445|183018568|OTHER||Slope|0.0556|STANDARD_ERROR_OF_MEAN|7.072||0.4332|TWO_SIDED|90.0|-0.06159|0.1728|||Mixed Models Analysis|||MM\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1728|-0.06159|0.4332
91565060|NCT04748445|183018568|OTHER||Slope|0.01214|STANDARD_ERROR_OF_MEAN|6.19||0.8448|TWO_SIDED|90.0|-0.09044|0.1147|||Mixed Models Analysis|||MM\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1147|-0.09044|0.8448
91565061|NCT04748445|183018568|OTHER||Slope|-0.1106|STANDARD_ERROR_OF_MEAN|4.852||0.0244|TWO_SIDED|90.0|-0.191|-0.03016|||Mixed Models Analysis|||MM\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03016|-0.1910|0.0244
91565062|NCT04748445|183018568|OTHER||Slope|-0.04884|STANDARD_ERROR_OF_MEAN|4.827||0.3136|TWO_SIDED|90.0|-0.1288|0.03115|||Mixed Models Analysis|||MM\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03115|-0.1288|0.3136
91565063|NCT04748445|183018568|OTHER||Slope|0.036|STANDARD_ERROR_OF_MEAN|5.634||0.524|TWO_SIDED|90.0|-0.05736|0.1294|||Mixed Models Analysis|||MM\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1294|-0.05736|0.5240
91565064|NCT04748445|183018568|OTHER||Slope|2.909|STANDARD_ERROR_OF_MEAN|3.096||0.3493|TWO_SIDED|90.0|-2.222|8.039|||Mixed Models Analysis|||MM\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||8.039|-2.222|0.3493
91565065|NCT04748445|183018568|OTHER||Slope|1.72|STANDARD_ERROR_OF_MEAN|2.595||0.5087|TWO_SIDED|90.0|-2.58|6.019|||Mixed Models Analysis|||MM\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.019|-2.580|0.5087
91565066|NCT04748445|183018568|OTHER||Slope|0.004403|STANDARD_ERROR_OF_MEAN|1.503||0.7701|TWO_SIDED|90.0|-0.02051|0.02931|||Mixed Models Analysis|||MM\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02931|-0.02051|0.7701
91565067|NCT04748445|183018568|OTHER||Slope|0.007542|STANDARD_ERROR_OF_MEAN|1.639||0.6461|TWO_SIDED|90.0|-0.01961|0.0347|||Mixed Models Analysis|||MM\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03470|-0.01961|0.6461
91565068|NCT04748445|183018568|OTHER||Slope|2.386|STANDARD_ERROR_OF_MEAN|8.233||0.0044|TWO_SIDED|90.0|1.022|3.75|||Mixed Models Analysis|||MM\_MFCC std 05 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.750|1.022|0.0044
91565069|NCT04748445|183018568|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.243||0.2022|TWO_SIDED|90.0|-4.663|3.652|||Mixed Models Analysis|||MM\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.652|-4.663|0.2022
91565070|NCT04748445|183018568|OTHER||Slope|0.002902|STANDARD_ERROR_OF_MEAN|1.082||0.789|TWO_SIDED|90.0|-0.01503|0.02084|||Mixed Models Analysis|||MM\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02084|-0.01503|0.7890
91565071|NCT04748445|183018568|OTHER||Slope|1.615|STANDARD_ERROR_OF_MEAN|1.118||0.151|TWO_SIDED|90.0|-2.371|3.467|||Mixed Models Analysis|||MM\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.467|-2.371|0.1510
91565072|NCT04748445|183018568|OTHER||Slope|1.116|STANDARD_ERROR_OF_MEAN|1.104||0.3138|TWO_SIDED|90.0|-7.126|2.945|||Mixed Models Analysis|||MM\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||2.945|-7.126|0.3138
91565073|NCT04748445|183018568|OTHER||Slope|-0.002168|STANDARD_ERROR_OF_MEAN|9.632||0.8223|TWO_SIDED|90.0|-0.01813|0.01379|||Mixed Models Analysis|||MM\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01379|-0.01813|0.8223
91565074|NCT04748445|183018568|OTHER||Slope|1.394|STANDARD_ERROR_OF_MEAN|1.081||0.1997|TWO_SIDED|90.0|-3.978|3.185|||Mixed Models Analysis|||MM\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.185|-3.978|0.1997
91565075|NCT04748445|183018568|OTHER||Slope|0.01375|STANDARD_ERROR_OF_MEAN|6.622||0.0398|TWO_SIDED|90.0|0.00278|0.02473|||Mixed Models Analysis|||MM\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02473|0.002780|0.0398
91565076|NCT04748445|183018568|OTHER||Slope|-0.002892|STANDARD_ERROR_OF_MEAN|1.205||0.8107|TWO_SIDED|90.0|-0.02286|0.01707|||Mixed Models Analysis|||MM\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01707|-0.02286|0.8107
91565077|NCT04748445|183018568|OTHER||Slope|-3.105|STANDARD_ERROR_OF_MEAN|3.256||0.9242|TWO_SIDED|90.0|-5.706|5.085|||Mixed Models Analysis|||MM\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.085|-5.706|0.9242
91565078|NCT04748445|183018568|OTHER||Slope|0.0006145|STANDARD_ERROR_OF_MEAN|9.704||0.5277|TWO_SIDED|90.0|-0.0009936|0.002223|||Mixed Models Analysis|||MM\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002223|-0.0009936|0.5277
91565079|NCT04748445|183018568|OTHER||Slope|-2.911|STANDARD_ERROR_OF_MEAN|1.969||0.1418|TWO_SIDED|90.0|-6.174|3.522|||Mixed Models Analysis|||MM\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||3.522|-6.174|0.1418
91565080|NCT04748445|183018568|OTHER||Slope|-0.1487|STANDARD_ERROR_OF_MEAN|8.77||0.0924|TWO_SIDED|90.0|-0.294|-0.003375|||Mixed Models Analysis|||MM\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.003375|-0.2940|0.0924
91565081|NCT04748445|183018568|OTHER||Slope|3.089|STANDARD_ERROR_OF_MEAN|3.396||0.9277|TWO_SIDED|90.0|-5.318|5.936|||Mixed Models Analysis|||MM\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.936|-5.318|0.9277
91565082|NCT04748445|183018568|OTHER||Slope|0.8362|STANDARD_ERROR_OF_MEAN|2.077|<|0.0001|TWO_SIDED|90.0|0.492|1.18|||Mixed Models Analysis|||READ\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.180|0.4920|<.0001
91565083|NCT04748445|183018568|OTHER||Slope|0.03559|STANDARD_ERROR_OF_MEAN|1.147||0.7568|TWO_SIDED|90.0|-0.1545|0.2256|||Mixed Models Analysis|||READ\_MFCC mean 02 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.2256|-0.1545|0.7568
91565084|NCT04748445|183018568|OTHER||Slope|0.2043|STANDARD_ERROR_OF_MEAN|7.752||0.0095|TWO_SIDED|90.0|0.07585|0.3328|||Mixed Models Analysis|||READ\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.3328|0.07585|0.0095
91565085|NCT04748445|183018568|OTHER||Slope|-0.0828|STANDARD_ERROR_OF_MEAN|6.413||0.1991|TWO_SIDED|90.0|-0.1891|0.02348|||Mixed Models Analysis|||READ\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02348|-0.1891|0.1991
91565086|NCT04748445|183018568|OTHER||Slope|-0.02415|STANDARD_ERROR_OF_MEAN|5.26||0.6469|TWO_SIDED|90.0|-0.1113|0.06301|||Mixed Models Analysis|||READ\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06301|-0.1113|0.6469
91565087|NCT04748445|183018568|OTHER||Slope|-0.1209|STANDARD_ERROR_OF_MEAN|4.904||0.015|TWO_SIDED|90.0|-0.2022|-0.03967|||Mixed Models Analysis|||READ\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03967|-0.2022|0.0150
91565088|NCT04748445|183018568|OTHER||Slope|0.02617|STANDARD_ERROR_OF_MEAN|4.639||0.5736|TWO_SIDED|90.0|-0.0507|0.103|||Mixed Models Analysis|||READ\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1030|-0.05070|0.5736
91565089|NCT04748445|183018568|OTHER||Slope|-0.07305|STANDARD_ERROR_OF_MEAN|4.267||0.0894|TWO_SIDED|90.0|-0.1438|-0.002335|||Mixed Models Analysis|||READ\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002335|-0.1438|0.0894
91565090|NCT04748445|183018568|OTHER||Slope|-2.369|STANDARD_ERROR_OF_MEAN|4.428||0.5936|TWO_SIDED|90.0|-9.706|4.968|||Mixed Models Analysis|||READ\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.968|-9.706|0.5936
91565091|NCT04748445|183018568|OTHER||Slope|-0.07377|STANDARD_ERROR_OF_MEAN|3.339||0.029|TWO_SIDED|90.0|-0.1291|-0.01844|||Mixed Models Analysis|||READ\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01844|-0.1291|0.0290
91565092|NCT04748445|183018568|OTHER||Slope|0.008703|STANDARD_ERROR_OF_MEAN|3.665||0.8127|TWO_SIDED|90.0|-0.05203|0.06944|||Mixed Models Analysis|||READ\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06944|-0.05203|0.8127
91565093|NCT04748445|183018568|OTHER||Slope|-0.07414|STANDARD_ERROR_OF_MEAN|3.294||0.0262|TWO_SIDED|90.0|-0.1287|-0.01955|||Mixed Models Analysis|||READ\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01955|-0.1287|0.0262
91565094|NCT04748445|183018568|OTHER||Slope|2.929|STANDARD_ERROR_OF_MEAN|2.705||0.2809|TWO_SIDED|90.0|-1.553|7.412|||Mixed Models Analysis|||READ\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.412|-1.553|0.2809
91565095|NCT04748445|183018568|OTHER||Slope|-2.717|STANDARD_ERROR_OF_MEAN|6.612|<|0.0001|TWO_SIDED|90.0|-3.812|-1.621|||Mixed Models Analysis|||READ\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.621|-3.812|<.0001
91565096|NCT04748445|183018568|OTHER||Slope|-0.05798|STANDARD_ERROR_OF_MEAN|2.961||0.0524|TWO_SIDED|90.0|-0.107|-0.008915|||Mixed Models Analysis|||READ\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008915|-0.1070|0.0524
91565097|NCT04748445|183018568|OTHER||Slope|-1.008|STANDARD_ERROR_OF_MEAN|1.778||0.5716|TWO_SIDED|90.0|-3.955|1.938|||Mixed Models Analysis|||READ\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||1.938|-3.955|0.5716
91565098|NCT04748445|183018568|OTHER||Slope|-0.0223|STANDARD_ERROR_OF_MEAN|1.193||0.064|TWO_SIDED|90.0|-0.04208|-0.002526|||Mixed Models Analysis|||READ\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002526|-0.04208|0.0640
91565099|NCT04748445|183018568|OTHER||Slope|-1.336|STANDARD_ERROR_OF_MEAN|1.176||0.2584|TWO_SIDED|90.0|-3.285|6.138|||Mixed Models Analysis|||READ\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||6.138|-3.285|0.2584
91565100|NCT04748445|183018568|OTHER||Slope|-0.006497|STANDARD_ERROR_OF_MEAN|1.413||0.6465|TWO_SIDED|90.0|-0.02992|0.01692|||Mixed Models Analysis|||READ\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01692|-0.02992|0.6465
91565101|NCT04748445|183018568|OTHER||Slope|-1.213|STANDARD_ERROR_OF_MEAN|7.7||0.1177|TWO_SIDED|90.0|-2.489|6.297|||Mixed Models Analysis|||READ\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3 and for upper limit it was 10\^-4).||6.297|-2.489|0.1177
91565102|NCT04748445|183018568|OTHER||Slope|-0.007959|STANDARD_ERROR_OF_MEAN|9.743||0.4155|TWO_SIDED|90.0|-0.02411|0.008187|||Mixed Models Analysis|||READ\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.008187|-0.02411|0.4155
91565103|NCT04748445|183018568|OTHER||Slope|-0.004137|STANDARD_ERROR_OF_MEAN|8.017||0.6067|TWO_SIDED|90.0|-0.01742|0.009148|||Mixed Models Analysis|||READ\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.009148|-0.01742|0.6067
91565104|NCT04748445|183018568|OTHER||Slope|0.000376|STANDARD_ERROR_OF_MEAN|7.531||0.9603|TWO_SIDED|90.0|-0.0121|0.01286|||Mixed Models Analysis|||READ\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01286|-0.01210|0.9603
91565105|NCT04748445|183018568|OTHER||Slope|-0.002185|STANDARD_ERROR_OF_MEAN|5.703||0.7022|TWO_SIDED|90.0|-0.01164|0.007265|||Mixed Models Analysis|||READ\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.007265|-0.01164|0.7022
91565106|NCT04748445|183018568|OTHER||Slope|0.007716|STANDARD_ERROR_OF_MEAN|5.746||0.1818|TWO_SIDED|90.0|-0.001806|0.01724|||Mixed Models Analysis|||READ\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01724|-0.001806|0.1818
91565107|NCT04748445|183018568|OTHER||Slope|-0.004019|STANDARD_ERROR_OF_MEAN|6.419||0.5324|TWO_SIDED|90.0|-0.01466|0.006618|||Mixed Models Analysis|||READ\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.006618|-0.01466|0.5324
91565108|NCT04748445|183018568|OTHER||Slope|0.005103|STANDARD_ERROR_OF_MEAN|2.737||0.8524|TWO_SIDED|90.0|-0.04025|0.05046|||Mixed Models Analysis|||READ\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.05046|-0.04025|0.8524
91565109|NCT04748445|183018569|OTHER||Slope|2.975|STANDARD_ERROR_OF_MEAN|3.383||0.3809|TWO_SIDED|90.0|-2.631|8.58|||Mixed Models Analysis|||EE\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4.||8.580|-2.631|0.3809
91565110|NCT04748445|183018569|OTHER||Slope|-0.005601|STANDARD_ERROR_OF_MEAN|2.751||0.0438|TWO_SIDED|90.0|-0.01016|-0.001043|||Mixed Models Analysis|||EE\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3.||-0.001043|-0.01016|0.0438
91565111|NCT04748445|183018569|OTHER||Slope|4.12|STANDARD_ERROR_OF_MEAN|1.464||0.0057|TWO_SIDED|90.0|1.694|6.546|||Mixed Models Analysis|||EE\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||6.546|1.694|0.0057
91565112|NCT04748445|183018569|OTHER||Slope|-3.067|STANDARD_ERROR_OF_MEAN|1.053||0.0042|TWO_SIDED|90.0|-4.811|-1.323|||Mixed Models Analysis|||EE\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||-1.323|-4.811|0.0042
91565113|NCT04748445|183018569|OTHER||Slope|2.78|STANDARD_ERROR_OF_MEAN|9.751||0.0051|TWO_SIDED|90.0|1.164|4.396|||Mixed Models Analysis|||EE\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-3. For dispersion value it was 10\^-4).||4.396|1.164|0.0051
91565114|NCT04748445|183018569|OTHER||Slope|-1.324|STANDARD_ERROR_OF_MEAN|8.289||0.1128|TWO_SIDED|90.0|-2.698|4.973|||Mixed Models Analysis|||EE\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-3. For upper limit it was 10\^-5 and for dispersion value it was 10\^-4).||4.973|-2.698|0.1128
91565115|NCT04748445|183018569|OTHER||Slope|-0.0002606|STANDARD_ERROR_OF_MEAN|9.707||0.7888|TWO_SIDED|90.0|-0.001869|0.001348|||Mixed Models Analysis|||EE\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001348|-0.001869|0.7888
91565116|NCT04748445|183018569|OTHER||Slope|-0.0005071|STANDARD_ERROR_OF_MEAN|7.593||0.5055|TWO_SIDED|90.0|-0.001765|0.0007512|||Mixed Models Analysis|||EE\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007512|-0.001765|0.5055
91565117|NCT04748445|183018569|OTHER||Slope|0.0003067|STANDARD_ERROR_OF_MEAN|6.273||0.6257|TWO_SIDED|90.0|-0.0007328|0.001346|||Mixed Models Analysis|||EE\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001346|-0.0007328|0.6257
91565118|NCT04748445|183018569|OTHER||Slope|-0.001649|STANDARD_ERROR_OF_MEAN|7.998||0.0413|TWO_SIDED|90.0|-0.002974|-0.0003238|||Mixed Models Analysis|||EE\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0003238|-0.002974|0.0413
91565119|NCT04748445|183018569|OTHER||Slope|0.0008236|STANDARD_ERROR_OF_MEAN|7.053||0.2451|TWO_SIDED|90.0|-0.0003452|0.001992|||Mixed Models Analysis|||EE\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001992|-0.0003452|0.2451
91565120|NCT04748445|183018569|OTHER||Slope|-0.000292|STANDARD_ERROR_OF_MEAN|6.839||0.6702|TWO_SIDED|90.0|-0.001425|0.0008413|||Mixed Models Analysis|||EE\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008413|-0.001425|0.6702
91565121|NCT04748445|183018569|OTHER||Slope|-0.0003363|STANDARD_ERROR_OF_MEAN|6.312||0.5951|TWO_SIDED|90.0|-0.001382|0.0007097|||Mixed Models Analysis|||EE\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007097|-0.001382|0.5951
91565122|NCT04748445|183018569|OTHER||Slope|0.0007281|STANDARD_ERROR_OF_MEAN|5.677||0.202|TWO_SIDED|90.0|-0.0002126|0.001669|||Mixed Models Analysis|||EE\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001669|-0.0002126|0.2020
91565123|NCT04748445|183018569|OTHER||Slope|0.0005153|STANDARD_ERROR_OF_MEAN|1.523||0.7356|TWO_SIDED|90.0|-0.002008|0.003038|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003038|-0.002008|0.7356
91565124|NCT04748445|183018569|OTHER||Slope|-0.00133|STANDARD_ERROR_OF_MEAN|6.782||0.0522|TWO_SIDED|90.0|-0.002453|-0.0002057|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002057|-0.002453|0.0522
91565125|NCT04748445|183018569|OTHER||Slope|-0.000156|STANDARD_ERROR_OF_MEAN|6.763||0.818|TWO_SIDED|90.0|-0.001277|0.0009647|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0009647|-0.001277|0.8180
91565126|NCT04748445|183018569|OTHER||Slope|-0.0000971|STANDARD_ERROR_OF_MEAN|6.18||0.8754|TWO_SIDED|90.0|-0.001121|0.000927|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4.||0.0009270|-0.001121|0.8754
91565127|NCT04748445|183018569|OTHER||Slope|0.000452|STANDARD_ERROR_OF_MEAN|5.576||0.4192|TWO_SIDED|90.0|-0.0004721|0.001376|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001376|-0.0004721|0.4192
91565128|NCT04748445|183018569|OTHER||Slope|-0.0001528|STANDARD_ERROR_OF_MEAN|5.586||0.7849|TWO_SIDED|90.0|-0.001079|0.0007729|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007729|-0.001079|0.7849
91565129|NCT04748445|183018569|OTHER||Slope|-5.254|STANDARD_ERROR_OF_MEAN|4.217||0.901|TWO_SIDED|90.0|-7.513|6.463|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-4. For estimated value it was 10\^-5).||6.463|-7.513|0.9010
91565130|NCT04748445|183018569|OTHER||Slope|-0.0004591|STANDARD_ERROR_OF_MEAN|3.83||0.2329|TWO_SIDED|90.0|-0.001094|0.0001755|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001755|-0.001094|0.2329
91565131|NCT04748445|183018569|OTHER||Slope|0.0007046|STANDARD_ERROR_OF_MEAN|3.687||0.0583|TWO_SIDED|90.0|0.00009366|0.001315|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|0.00009366|0.0583
91565132|NCT04748445|183018569|OTHER||Slope|-1.564|STANDARD_ERROR_OF_MEAN|3.606||0.6654|TWO_SIDED|90.0|-7.54|4.413|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||4.413|-7.540|0.6654
91565133|NCT04748445|183018569|OTHER||Slope|0.00006573|STANDARD_ERROR_OF_MEAN|2.81||0.8154|TWO_SIDED|90.0|-0.0003998|0.0005313|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005313|-0.0003998|0.8154
91565134|NCT04748445|183018569|OTHER||Slope|-0.0004071|STANDARD_ERROR_OF_MEAN|3.664||0.2687|TWO_SIDED|90.0|-0.001014|0.0002001|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002001|-0.001014|0.2687
91565135|NCT04748445|183018569|OTHER||Slope|2.799|STANDARD_ERROR_OF_MEAN|3.317||0.4005|TWO_SIDED|90.0|-2.698|8.296|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.296|-2.698|0.4005
91565136|NCT04748445|183018569|OTHER||Slope|1.123|STANDARD_ERROR_OF_MEAN|1.676||0.504|TWO_SIDED|90.0|-1.654|3.901|||Mixed Models Analysis|||MM\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.901|-1.654|0.5040
91565137|NCT04748445|183018569|OTHER||Slope|0.00007586|STANDARD_ERROR_OF_MEAN|2.882||0.979|TWO_SIDED|90.0|-0.004701|0.004852|||Mixed Models Analysis|||MM\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.004852|-0.004701|0.9790
91565138|NCT04748445|183018569|OTHER||Slope|0.0008249|STANDARD_ERROR_OF_MEAN|1.815||0.6503|TWO_SIDED|90.0|-0.002183|0.003833|||Mixed Models Analysis|||MM\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003833|-0.002183|0.6503
91565139|NCT04748445|183018569|OTHER||Slope|-1.188|STANDARD_ERROR_OF_MEAN|1.322||0.3705|TWO_SIDED|90.0|-3.379|1.003|||Mixed Models Analysis|||MM\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||1.003|-3.379|0.3705
91565140|NCT04748445|183018569|OTHER||Slope|-0.0007258|STANDARD_ERROR_OF_MEAN|1.101||0.5111|TWO_SIDED|90.0|-0.002551|0.001099|||Mixed Models Analysis|||MM\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.001099|-0.002551|0.5111
91565141|NCT04748445|183018569|OTHER||Slope|-0.001326|STANDARD_ERROR_OF_MEAN|7.555||0.0816|TWO_SIDED|90.0|-0.002578|-0.0000744|||Mixed Models Analysis|||MM\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0000744|-0.002578|0.0816
91565142|NCT04748445|183018569|OTHER||Slope|0.0005502|STANDARD_ERROR_OF_MEAN|1.056||0.6034|TWO_SIDED|90.0|-0.0012|0.002301|||Mixed Models Analysis|||MM\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.002301|-0.001200|0.6034
91565143|NCT04748445|183018569|OTHER||Slope|-0.0004691|STANDARD_ERROR_OF_MEAN|7.305||0.522|TWO_SIDED|90.0|-0.00168|0.0007415|||Mixed Models Analysis|||MM\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007415|-0.001680|0.5220
91565144|NCT04748445|183018569|OTHER||Slope|-0.00153|STANDARD_ERROR_OF_MEAN|7.82||0.0526|TWO_SIDED|90.0|-0.002826|-0.0002344|||Mixed Models Analysis|||MM\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002344|-0.002826|0.0526
91565145|NCT04748445|183018569|OTHER||Slope|0.0004166|STANDARD_ERROR_OF_MEAN|7.294||0.5689|TWO_SIDED|90.0|-0.000792|0.001625|||Mixed Models Analysis|||MM\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001625|-0.0007920|0.5689
91565146|NCT04748445|183018569|OTHER||Slope|-0.002112|STANDARD_ERROR_OF_MEAN|7.299||0.0045|TWO_SIDED|90.0|-0.003321|-0.000902|||Mixed Models Analysis|||MM\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0009020|-0.003321|0.0045
91565147|NCT04748445|183018569|OTHER||Slope|-0.0007706|STANDARD_ERROR_OF_MEAN|7.494||0.3058|TWO_SIDED|90.0|-0.002013|0.0004713|||Mixed Models Analysis|||MM\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0004713|-0.002013|0.3058
91565148|NCT04748445|183018569|OTHER||Slope|0.0002388|STANDARD_ERROR_OF_MEAN|6.494||0.7137|TWO_SIDED|90.0|-0.0008374|0.001315|||Mixed Models Analysis|||MM\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|-0.0008374|0.7137
91565149|NCT04748445|183018569|OTHER||Slope|0.0002121|STANDARD_ERROR_OF_MEAN|6.877||0.7583|TWO_SIDED|90.0|-0.0009275|0.001352|||Mixed Models Analysis|||MM\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001352|-0.0009275|0.7583
91565150|NCT04748445|183018569|OTHER||Slope|-2.784|STANDARD_ERROR_OF_MEAN|1.667||0.0974|TWO_SIDED|90.0|-5.547|-2.155|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit it was 10\^-5. For lower limit, estimated value and dispersion value it was 10\^-3).||-2.155|-5.547|0.0974
91565151|NCT04748445|183018569|OTHER||Slope|-1.368|STANDARD_ERROR_OF_MEAN|9.117||0.881|TWO_SIDED|90.0|-1.648|1.374|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and lower limit it was 10\^-3. For estimated value and dispersion value it was 10\^-4).||1.374|-1.648|0.8810
91565152|NCT04748445|183018569|OTHER||Slope|-0.001551|STANDARD_ERROR_OF_MEAN|6.294||0.0151|TWO_SIDED|90.0|-0.002594|-0.0005077|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0005077|-0.002594|0.0151
91565153|NCT04748445|183018569|OTHER||Slope|0.00184|STANDARD_ERROR_OF_MEAN|7.343||0.0135|TWO_SIDED|90.0|0.0006233|0.003057|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.003057|0.0006233|0.0135
91565154|NCT04748445|183018569|OTHER||Slope|0.00129|STANDARD_ERROR_OF_MEAN|5.029||0.0115|TWO_SIDED|90.0|0.0004563|0.002123|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002123|0.0004563|0.0115
91565155|NCT04748445|183018569|OTHER||Slope|-0.0001473|STANDARD_ERROR_OF_MEAN|5.891||0.8029|TWO_SIDED|90.0|-0.001123|0.0008288|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008288|-0.001123|0.8029
91565156|NCT04748445|183018569|OTHER||Slope|-0.0005556|STANDARD_ERROR_OF_MEAN|4.647||0.2342|TWO_SIDED|90.0|-0.001326|0.0002146|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002146|-0.001326|0.2342
91565157|NCT04748445|183018569|OTHER||Slope|0.001128|STANDARD_ERROR_OF_MEAN|5.339||0.0366|TWO_SIDED|90.0|0.0002436|0.002013|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002013|0.0002436|0.0366
91565158|NCT04748445|183018569|OTHER||Slope|-0.0003297|STANDARD_ERROR_OF_MEAN|5.134||0.522|TWO_SIDED|90.0|-0.00118|0.0005212|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005212|-0.001180|0.5220
91565159|NCT04748445|183018569|OTHER||Slope|-2.104|STANDARD_ERROR_OF_MEAN|3.528||0.552|TWO_SIDED|90.0|-7.95|3.742|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.742|-7.950|0.5520
91565160|NCT04748445|183018569|OTHER||Slope|0.0005126|STANDARD_ERROR_OF_MEAN|4.289||0.2343|TWO_SIDED|90.0|-0.0001981|0.001223|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For ldispersion value it was 10\^-4).||0.001223|-0.0001981|0.2343
91565161|NCT04748445|183018569|OTHER||Slope|2.703|STANDARD_ERROR_OF_MEAN|4.094||0.5103|TWO_SIDED|90.0|-4.081|9.487|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||9.487|-4.081|0.5103
91565162|NCT04748445|183018569|OTHER||Slope|-0.000202|STANDARD_ERROR_OF_MEAN|5.334||0.7056|TWO_SIDED|90.0|-0.001086|0.0006819|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006819|-0.001086|0.7056
91565163|NCT04748445|183018569|OTHER||Slope|-2.66|STANDARD_ERROR_OF_MEAN|9.22||0.0046|TWO_SIDED|90.0|-4.188|-1.132|||Mixed Models Analysis|||READ\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||-1.132|-4.188|0.0046
91565164|NCT04748445|183018569|OTHER||Slope|0.000649|STANDARD_ERROR_OF_MEAN|4.448||0.1471|TWO_SIDED|90.0|-0.0000881|0.001386|||Mixed Models Analysis|||READ\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001386|-0.0000881|0.1471
91565165|NCT04748445|183018569|OTHER||Slope|1.355|STANDARD_ERROR_OF_MEAN|3.323||0.6842|TWO_SIDED|90.0|-4.152|6.862|||Mixed Models Analysis|||READ\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.862|-4.152|0.6842
91565166|NCT04748445|183018569|OTHER||Slope|0.00007664|STANDARD_ERROR_OF_MEAN|2.574||0.7664|TWO_SIDED|90.0|-0.0003499|0.0005032|||Mixed Models Analysis|||READ\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005032|-0.0003499|0.7664
91565167|NCT04748445|183018569|OTHER||Slope|-1.708|STANDARD_ERROR_OF_MEAN|2.028||0.4015|TWO_SIDED|90.0|-5.069|1.654|||Mixed Models Analysis|||READ\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||1.654|-5.069|0.4015
91565168|NCT04748445|183018569|OTHER||Slope|2.51|STANDARD_ERROR_OF_MEAN|1.904||0.1897|TWO_SIDED|90.0|-6.446|5.665|||Mixed Models Analysis|||READ\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.665|-6.446|0.1897
91565169|NCT04748445|183018569|OTHER||Slope|2.393|STANDARD_ERROR_OF_MEAN|1.627||0.1439|TWO_SIDED|90.0|-3.035|5.09|||Mixed Models Analysis|||READ\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.090|-3.035|0.1439
91565170|NCT04748445|183018569|OTHER||Slope|4.111|STANDARD_ERROR_OF_MEAN|1.553||0.0092|TWO_SIDED|90.0|1.537|6.685|||Mixed Models Analysis|||READ\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.685|1.537|0.0092
91565171|NCT04748445|183018569|OTHER||Slope|-0.0000415|STANDARD_ERROR_OF_MEAN|1.134||0.715|TWO_SIDED|90.0|-0.0002294|0.0001464|||Mixed Models Analysis|||READ\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001464|-0.0002294|0.7150
91565172|NCT04748445|183018569|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.291||0.2194|TWO_SIDED|90.0|-5.457|3.731|||Mixed Models Analysis|||READ\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.731|-5.457|0.2194
91565173|NCT04748445|183018569|OTHER||Slope|0.0001893|STANDARD_ERROR_OF_MEAN|9.442||0.0471|TWO_SIDED|90.0|0.00003283|0.0003458|||Mixed Models Analysis|||READ\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003458|0.00003283|0.0471
91565174|NCT04748445|183018569|OTHER||Slope|0.000138|STANDARD_ERROR_OF_MEAN|6.614||0.039|TWO_SIDED|90.0|0.0000284|0.0002476|||Mixed Models Analysis|||READ\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002476|0.00002840|0.0390
91565175|NCT04748445|183018569|OTHER||Slope|1.166|STANDARD_ERROR_OF_MEAN|1.04||0.2645|TWO_SIDED|90.0|-5.579|2.89|||Mixed Models Analysis|||READ\_MFCC 1st order delta 13 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||2.890|-5.579|0.2645
91565176|NCT04748445|183018569|OTHER||Slope|-0.00119|STANDARD_ERROR_OF_MEAN|5.79||0.042|TWO_SIDED|90.0|-0.002149|-0.0002303|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002303|-0.002149|0.0420
91565177|NCT04748445|183018569|OTHER||Slope|-4.504|STANDARD_ERROR_OF_MEAN|3.04||0.141|TWO_SIDED|90.0|-9.542|5.341|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-5).||5.341|-9.542|0.1410
91565178|NCT04748445|183018569|OTHER||Slope|2.968|STANDARD_ERROR_OF_MEAN|3.334||0.3751|TWO_SIDED|90.0|-2.557|8.492|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.492|-2.557|0.3751
91565179|NCT04748445|183018569|OTHER||Slope|-0.0000796|STANDARD_ERROR_OF_MEAN|2.101||0.7053|TWO_SIDED|90.0|-0.0004277|0.0002685|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002685|-0.0004277|0.7053
91565180|NCT04748445|183018569|OTHER||Slope|5.075|STANDARD_ERROR_OF_MEAN|1.878||0.0078|TWO_SIDED|90.0|1.964|8.187|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.187|1.964|0.0078
91565181|NCT04748445|183018569|OTHER||Slope|-1.88|STANDARD_ERROR_OF_MEAN|1.174||0.1119|TWO_SIDED|90.0|-3.826|6.611|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-6).||6.611|-3.826|0.1119
91565182|NCT04748445|183018569|OTHER||Slope|1.667|STANDARD_ERROR_OF_MEAN|1.164||0.1545|TWO_SIDED|90.0|-2.615|3.596|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.596|-2.615|0.1545
91565183|NCT04748445|183018569|OTHER||Slope|1.531|STANDARD_ERROR_OF_MEAN|9.552||0.1114|TWO_SIDED|90.0|-5.164|3.114|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-4. For lower limit it was 10\^-6 and for dispersion value it was 10\^-5).||3.114|-5.164|0.1114
91565184|NCT04748445|183018569|OTHER||Slope|0.0001989|STANDARD_ERROR_OF_MEAN|1.076||0.0668|TWO_SIDED|90.0|0.00002067|0.0003772|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0003772|0.00002067|0.0668
91565185|NCT04748445|183018569|OTHER||Slope|0.00005573|STANDARD_ERROR_OF_MEAN|9.318||0.5509|TWO_SIDED|90.0|-0.0000986|0.0002101|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002101|-0.0000986|0.5509
91565186|NCT04748445|183018569|OTHER||Slope|0.00001774|STANDARD_ERROR_OF_MEAN|8.677||0.8383|TWO_SIDED|90.0|-0.000126|0.0001615|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001615|-0.0001260|0.8383
91565187|NCT04748445|183018569|OTHER||Slope|0.00007327|STANDARD_ERROR_OF_MEAN|6.63||0.2713|TWO_SIDED|90.0|-0.0000366|0.0001831|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001831|-0.0000366|0.2713
91565188|NCT04748445|183018569|OTHER||Slope|0.0001534|STANDARD_ERROR_OF_MEAN|9.067||0.0931|TWO_SIDED|90.0|0.00000317|0.0003037|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003037|0.00000317|0.0931
91565189|NCT04748445|183018570|OTHER||Slope|-1.931|STANDARD_ERROR_OF_MEAN|3.554||0.5878|TWO_SIDED|90.0|-7.82|3.958|||Mixed Models Analysis|||EE\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||3.958|-7.820|0.5878
91565190|NCT04748445|183018570|OTHER||Slope|-1.479|STANDARD_ERROR_OF_MEAN|2.847||0.9587|TWO_SIDED|90.0|-4.866|4.57|||Mixed Models Analysis|||MM\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-4. For dispersion value, lower limit and upper limit it was 10\^-3).||4.570|-4.866|0.9587
91565191|NCT04748445|183018571|OTHER||Slope|-3.262|STANDARD_ERROR_OF_MEAN|4.487||0.9421|TWO_SIDED|90.0|-7.761|7.109|||Mixed Models Analysis|||EE\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-1. For estimated value it was 10\^-2).||7.109|-7.761|0.9421
91565192|NCT04748445|183018571|OTHER||Slope|-0.06912|STANDARD_ERROR_OF_MEAN|5.997||0.9084|TWO_SIDED|90.0|-1.063|0.9247|||Mixed Models Analysis|||EE\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.9247|-1.063|0.9084
91565193|NCT04748445|183018571|OTHER||Slope|1.985|STANDARD_ERROR_OF_MEAN|1.23||0.8721|TWO_SIDED|90.0|-1.841|2.238|||Mixed Models Analysis|||EE\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^0. For estimated value it was 10\^-1).||2.238|-1.841|0.8721
91565194|NCT04748445|183018571|OTHER||Slope|0.6573|STANDARD_ERROR_OF_MEAN|2.191||0.7647|TWO_SIDED|90.0|-2.974|4.288|||Mixed Models Analysis|||EE\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.288|-2.974|0.7647
91565195|NCT04748445|183018571|OTHER||Slope|0.6504|STANDARD_ERROR_OF_MEAN|8.958||0.4692|TWO_SIDED|90.0|-0.8341|2.135|||Mixed Models Analysis|||EE\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.135|-0.8341|0.4692
91565196|NCT04748445|183018571|OTHER||Slope|-0.09459|STANDARD_ERROR_OF_MEAN|1.255||0.94|TWO_SIDED|90.0|-2.174|1.985|||Mixed Models Analysis|||EE\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.985|-2.174|0.9400
91565197|NCT04748445|183018571|OTHER||Slope|0.6945|STANDARD_ERROR_OF_MEAN|7.972||0.3853|TWO_SIDED|90.0|-0.6265|2.015|||Mixed Models Analysis|||MM\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.015|-0.6265|0.3853
91565198|NCT04748445|183018571|OTHER||Slope|0.02424|STANDARD_ERROR_OF_MEAN|1.021||0.9811|TWO_SIDED|90.0|-1.667|1.716|||Mixed Models Analysis|||MM\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.716|-1.667|0.9811
91565199|NCT04748445|183018571|OTHER||Slope|-0.9256|STANDARD_ERROR_OF_MEAN|1.083||0.3944|TWO_SIDED|90.0|-2.72|0.869|||Mixed Models Analysis|||MM\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||0.8690|-2.720|0.3944
91565200|NCT04748445|183018571|OTHER||Slope|0.935|STANDARD_ERROR_OF_MEAN|1.289||0.4696|TWO_SIDED|90.0|-1.201|3.071|||Mixed Models Analysis|||MM\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||3.071|-1.201|0.4696
91565201|NCT04748445|183018571|OTHER||Slope|2.105|STANDARD_ERROR_OF_MEAN|1.231||0.0896|TWO_SIDED|90.0|0.06596|4.145|||Mixed Models Analysis|||MM\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.145|0.06596|0.0896
91565202|NCT04748445|183018571|OTHER||Slope|1.664|STANDARD_ERROR_OF_MEAN|1.358||0.2227|TWO_SIDED|90.0|-5.864|3.915|||Mixed Models Analysis|||MM\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^0. For lower limit it was 10\^-1).||3.915|-5.864|0.2227
91565203|NCT04748445|183018572|OTHER||Slope|-4.024|STANDARD_ERROR_OF_MEAN|3.122||0.8977|TWO_SIDED|90.0|-5.577|4.772|||Mixed Models Analysis|||EE\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||4.772|-5.577|0.8977
91565204|NCT04748445|183018572|OTHER||Slope|-0.0006624|STANDARD_ERROR_OF_MEAN|7.961||0.407|TWO_SIDED|90.0|-0.001982|0.0006569|||Mixed Models Analysis|||MM\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006569|-0.001982|0.4070
91565205|NCT04748445|183018573|OTHER||Slope|0.0008654|STANDARD_ERROR_OF_MEAN|1.441||0.5491|TWO_SIDED|90.0|-0.001522|0.003253|||Mixed Models Analysis|||EE\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003253|-0.001522|0.5491
91565206|NCT04748445|183018573|OTHER||Slope|-2.206|STANDARD_ERROR_OF_MEAN|3.176||0.9447|TWO_SIDED|90.0|-5.483|5.042|||Mixed Models Analysis|||MM\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||5.042|-5.483|0.9447
91565207|NCT04748445|183018574|OTHER||Slope|0.007567|STANDARD_ERROR_OF_MEAN|1.12||0.5004|TWO_SIDED|90.0|-0.01099|0.02612|||Mixed Models Analysis|||EE\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02612|-0.01099|0.5004
91565208|NCT04748445|183018574|OTHER||Slope|0.00606|STANDARD_ERROR_OF_MEAN|1.101||0.5831|TWO_SIDED|90.0|-0.01219|0.02431|||Mixed Models Analysis|||MM\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02431|-0.01219|0.5831
91565209|NCT04748445|183018575|OTHER||Slope|2.13|STANDARD_ERROR_OF_MEAN|3.211|<|0.0001|TWO_SIDED|90.0|1.598|2.662|||Mixed Models Analysis|||READ\_Speaking Rate (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||2.662|1.598|<.0001
91565210|NCT00938041|183018609|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
91565211|NCT00938041|183018609|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with confirmed complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
91565212|NCT03042559|183018628|SUPERIORITY|||||||||||||a priori threshold for statistical significance is \<0.05.|Wilcoxon (Mann-Whitney)|||Data analysis was performed using SPSS Statistics Software version 24.0. We compared mean age (years), Body Mass Index (kg/m2) (BMI), pain duration, and the outcome measures at baseline in both groups at baseline using independent t-test when the distribution of the variable was approximately normal and Mann-Whitney test when the distribution was not normal. The distribution of qualitative variables (gender, affected leg) by group type was examined using Chi Square test.|a priori threshold for statistical significance is \<0.05.|||
91565213|NCT03042559|183018635|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91565214|NCT01485991|183018664|SUPERIORITY_OR_OTHER||Difference in proportions|-1.1||||0.001|TWO_SIDED|95.0|-7.8|5.5||based on the asymptotic distribution of the generalized Cochran-Mantel-Haenszel statistic controlling for stratification factors, using a non-inferiority margin of 12 percent|Stratified Cochran-Mantel-Haenszel|||||5.5|-7.8|0.001
91565215|NCT04474691|183018668|SUPERIORITY||Mean Difference (Final Values)|21.1||||0.67|TWO_SIDED||||||t-test, 1 sided|df = 7|Traditional treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower acoustic values, a positive difference would indicate an advantage for biofeedback.|||||.67
91565216|NCT01370564|183018676|OTHER|There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.|Rao-Scott estimator for clustered data|72.0|||||TWO_SIDED|95.0|65.0|78.0||||||||78|65|
91565217|NCT03740919|183018688|NON_INFERIORITY|Noninferiority margin \[NIM\]=0.4% for HbA1c|Least Squares (LS) Mean Difference|-0.02||||0.783|TWO_SIDED|95.0|-0.17|0.13|||Mixed Models Analysis|||||0.13|-0.17|0.783
91565218|NCT03740919|183018689|NON_INFERIORITY|NIM of 0.4%|LS Mean Difference|-0.02||||0.867|TWO_SIDED|95.0|-0.2|0.17|||Mixed Models Analysis|||||0.17|-0.20|0.867
91565219|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|1.61||||0.008|TWO_SIDED|95.0|1.13|2.3|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||2.30|1.13|0.008
91565220|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|1.17||||0.487|TWO_SIDED|95.0|0.75|1.83|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.83|0.75|0.487
91565221|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|0.73||||0.153|TWO_SIDED|95.0|0.47|1.13|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.13|0.47|0.153
91565222|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|1.49||||0.02|TWO_SIDED|95.0|1.06|2.08|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||2.08|1.06|0.020
91565223|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|1.17||||0.455|TWO_SIDED|95.0|0.78|1.76|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.76|0.78|0.455
91565224|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|0.79||||0.259|TWO_SIDED|95.0|0.52|1.19|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.19|0.52|0.259
91565225|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.29|2.51|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||2.51|1.29|<0.001
91565226|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||1.43|0.64|0.822
91565227|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|0.53||||0.003|TWO_SIDED|95.0|0.35|0.8|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||0.80|0.35|0.003
91565228|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|1.42||||0.092|TWO_SIDED|95.0|0.94|2.14|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||2.14|0.94|0.092
91565229|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|0.71||||0.133|TWO_SIDED|95.0|0.45|1.11|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||1.11|0.45|0.133
91565230|NCT03740919|183018690|SUPERIORITY||Odds Ratio (OR)|0.5||||0.004|TWO_SIDED|95.0|0.31|0.8|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||0.80|0.31|0.004
91565231|NCT03740919|183018691|SUPERIORITY|||||||0.22|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.220
91565232|NCT03740919|183018691|SUPERIORITY|||||||0.599|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.599
91565233|NCT03740919|183018691|SUPERIORITY|||||||0.112|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.112
91565234|NCT03740919|183018691|SUPERIORITY|||||||0.034|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.034
91565235|NCT03740919|183018691|SUPERIORITY|||||||0.055|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.055
91565236|NCT03740919|183018691|SUPERIORITY|||||||0.814|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.814
91565237|NCT03740919|183018691|SUPERIORITY|||||||0.194|||||||Negative binomial regression|||≤70 mg/dL 1 hour post-dose||||0.194
91565238|NCT03740919|183018691|SUPERIORITY|||||||0.428|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.428
91565239|NCT03740919|183018691|SUPERIORITY|||||||0.057|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.057
91565240|NCT03740919|183018691|SUPERIORITY|||||||0.056|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model||≤70 mg/dL 2 hour post-dose||||0.056
91565241|NCT03740919|183018691|SUPERIORITY|||||||0.435|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.435
91565242|NCT03740919|183018691|SUPERIORITY|||||||0.404|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.404
91565243|NCT03740919|183018692|SUPERIORITY||Odds Ratio (OR)|1.04||||0.864|TWO_SIDED|95.0|0.68|1.57|||Regression, Logistic|||\<54 mg/dL||1.57|0.68|0.864
91565244|NCT03740919|183018692|SUPERIORITY||Odds Ratio (OR)|0.69||||0.132|TWO_SIDED|95.0|0.43|1.12|||Regression, Logistic|||\<54 mg/dL||1.12|0.43|0.132
91565245|NCT03740919|183018692|SUPERIORITY||Odds Ratio (OR)|0.67||||0.104|TWO_SIDED|95.0|0.41|1.09|||Regression, Logistic|||||1.09|0.41|0.104
91565246|NCT03740919|183018692|SUPERIORITY||Odds Ratio (OR)|0.8||||0.489|TWO_SIDED|95.0|0.42|1.52|||Regression, Logistic|||≤70 mg/dL||1.52|0.42|0.489
91565247|NCT03740919|183018692|SUPERIORITY||Odds Ratio (OR)|0.45||||0.025|TWO_SIDED|95.0|0.23|0.9|||Regression, Logistic|||≤70 mg/dL||0.90|0.23|0.025
91565248|NCT03740919|183018692|SUPERIORITY||Odds Ratio (OR)|0.57||||0.099|TWO_SIDED|95.0|0.29|1.11|||Regression, Logistic|||≤70 mg/dL||1.11|0.29|0.099
91565249|NCT03740919|183018693|SUPERIORITY|||||||0.732|||||||Negative binomial regression|||\< 54 mg/dL||||0.732
91565250|NCT03740919|183018693|SUPERIORITY|||||||0.638|||||||Negative binomial regression|||\< 54 mg/dL||||0.638
91565251|NCT03740919|183018693|SUPERIORITY|||||||0.462|||||||Negative binomial regression|||\<54 mg/dL||||0.462
91565252|NCT03740919|183018693|SUPERIORITY|||||||0.632|||||||Negative binomial regression|||≤ 70 mg/dL||||0.632
91565253|NCT03740919|183018693|SUPERIORITY|||||||0.8|||||||Negative binomial regression|||≤ 70 mg/dL||||0.800
91565254|NCT03740919|183018693|SUPERIORITY|||||||0.889|||||||Negative binomial regression|||≤ 70 mg/dL||||0.889
91565255|NCT03740919|183018695|SUPERIORITY||LS Mean Difference|0.6||||0.13|TWO_SIDED|95.0|-0.2|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.2|0.130
91565256|NCT03740919|183018695|SUPERIORITY||LS Mean Difference|0.4||||0.404|TWO_SIDED|95.0|-0.5|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.5|0.404
91565257|NCT03740919|183018695|SUPERIORITY||LS Mean Difference|-0.2||||0.693|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||Total Daily Basal Insulin||0.8|-1.2|0.693
91565258|NCT03740919|183018695|SUPERIORITY||LS Mean Difference|0.5||||0.625|TWO_SIDED|95.0|-1.4|2.3|||Mixed Models Analysis|||Total Daily Insulin Dose||2.3|-1.4|0.625
91565259|NCT03740919|183018695|SUPERIORITY||LS Mean Difference|-0.4||||0.758|TWO_SIDED|95.0|-2.6|1.9|||Mixed Models Analysis|||Total Daily Insulin Dose||1.9|-2.6|0.758
91565260|NCT03740919|183018695|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.485|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Total Daily Insulin Dose||1.5|-3.1|0.485
91565261|NCT03740919|183018696|SUPERIORITY||Odds Ratio (OR)|1.23||||0.396|TWO_SIDED|95.0|0.76|2.0|||Regression, Logistic|||HbA1c \< 7%||2.00|0.76|0.396
91565262|NCT03740919|183018696|SUPERIORITY||Odds Ratio (OR)|0.93||||0.814|TWO_SIDED|95.0|0.49|1.75|||Regression, Logistic|||HbA1c \< 7%||1.75|0.49|0.814
91565263|NCT03740919|183018696|SUPERIORITY||Odds Ratio (OR)|0.75||||0.384|TWO_SIDED|95.0|0.39|1.43|||Regression, Logistic|||HbA1c \< 7%||1.43|0.39|0.384
91565264|NCT03740919|183018696|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4|TWO_SIDED|95.0|0.55|1.27|||Regression, Logistic|||HbA1c \< 7.5%||1.27|0.55|0.400
91565265|NCT03740919|183018696|SUPERIORITY||Odds Ratio (OR)|0.62||||0.094|TWO_SIDED|95.0|0.36|1.08|||Regression, Logistic|||HbA1c \< 7.5%||1.08|0.36|0.094
91565266|NCT03740919|183018696|SUPERIORITY||Odds Ratio (OR)|0.75||||0.306|TWO_SIDED|95.0|0.43|1.31|||Regression, Logistic|||HbA1c \< 7.5%||1.31|0.43|0.306
91565267|NCT01207453|183018705|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed rank tests.||||0.42
91565268|NCT01207453|183018705|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.37
91565269|NCT01207453|183018706|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using the Wilcoxon signed-rank tests.||||0.39
91565270|NCT01207453|183018706|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.96
91565271|NCT01207453|183018707|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
91565272|NCT01207453|183018707|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.83
91565273|NCT01207453|183018708|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.04
91565274|NCT01207453|183018708|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.04
91565275|NCT01207453|183018709|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
91565276|NCT01207453|183018709|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.44
91565277|NCT01207453|183018710|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.35
91565278|NCT01207453|183018710|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.34
91565279|NCT01207453|183018711|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.72
91565280|NCT01207453|183018711|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.82
91565281|NCT02680145|183018746|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
91565282|NCT02680145|183018747|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
91565283|NCT02680145|183018748|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.005
91565284|NCT02329223|183018752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.31|-2.098|||Mixed Model with repeated measures(MMRM)|||||-2.098|-5.310|<0.001
91565285|NCT02329223|183018752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.29|STANDARD_ERROR_OF_MEAN|0.828||0.006|TWO_SIDED|95.0|-3.921|-0.654|||Mixed Model with repeated measures(MMRM)|||||-0.654|-3.921|0.006
91565286|NCT03443063|183018763|OTHER||Percent (%) ratio of geometric means|104.83|||||TWO_SIDED|90.0|77.41|141.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||141.97|77.41|
91565287|NCT03443063|183018764|OTHER||Percent (%) ratio of geometric means|133.03|||||TWO_SIDED|90.0|107.3|164.93|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||164.93|107.30|
91565288|NCT03443063|183018765|OTHER||Percent (%) ratio of geometric means|150.53|||||TWO_SIDED|90.0|113.16|200.26|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||200.26|113.16|
91565289|NCT03443063|183018766|OTHER||Percent (%) ratio of geometric means|149.84|||||TWO_SIDED|90.0|113.06|198.58|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||198.58|113.06|
91565290|NCT03443063|183018767|OTHER||Percent (%) ratio of geometric means|80.09|||||TWO_SIDED|90.0|56.07|114.4|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||114.40|56.07|
91565291|NCT03443063|183018767|OTHER||Percent (%) ratio of geometric means|79.51|||||TWO_SIDED|90.0|54.48|116.03|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||116.03|54.48|
91565292|NCT03443063|183018767|OTHER||Percent (%) ratio of geometric means|72.49|||||TWO_SIDED|90.0|48.08|109.29|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||109.29|48.08|
91565293|NCT03443063|183018769|OTHER||Percent (%) ratio of geometric mean|111.25|||||TWO_SIDED|90.0|91.69|134.99|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||134.99|91.69|
91565294|NCT03443063|183018769|OTHER||Percent (%) ratio of geometric means|80.28|||||TWO_SIDED|90.0|56.81|113.46|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||113.46|56.81|
91565295|NCT03443063|183018769|OTHER||Percent (%) ratio of geometric means|86.71|||||TWO_SIDED|90.0|64.92|115.81|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||115.81|64.92|
91565296|NCT03443063|183018769|OTHER||Percent (%) ratio of geometric means|65.38|||||TWO_SIDED|90.0|41.08|104.04|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||104.04|41.08|
91565297|NCT03443063|183018770|OTHER||Percent (%) ratio of geometric means|114.69|||||TWO_SIDED|90.0|94.45|139.28|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||139.28|94.45|
91565298|NCT03443063|183018770|OTHER||Percent (%) ratio of geometric means|124.94|||||TWO_SIDED|90.0|100.27|155.67|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||155.67|100.27|
91565299|NCT03443063|183018770|OTHER||Percent (%) ratio of geometric means|92.05|||||TWO_SIDED|90.0|66.87|126.71|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||126.71|66.87|
91565300|NCT03443063|183018771|OTHER||Percent (%) ratio of geometric means|136.28|||||TWO_SIDED|90.0|105.62|175.85|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||175.85|105.62|
91565301|NCT03443063|183018771|OTHER||Percent (%) ratio of geometric means|154.29|||||TWO_SIDED|90.0|117.53|202.57|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||202.57|117.53|
91565302|NCT03443063|183018771|OTHER||Percent (%) ratio of geometric means|118.54|||||TWO_SIDED|90.0|87.84|159.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||159.97|87.84|
91565303|NCT03443063|183018772|OTHER||Percent (%) ratio of geometric means|138.62|||||TWO_SIDED|90.0|109.1|176.14|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||176.14|109.10|
91565304|NCT03443063|183018772|OTHER||Percent (%) ratio of geometric means|147.03|||||TWO_SIDED|90.0|109.06|198.22|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||198.22|109.06|
91565305|NCT03443063|183018772|OTHER||Percent (%) ratio of geometric means|136.42|||||TWO_SIDED|90.0|98.19|189.54|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||189.54|98.19|
91565306|NCT03443063|183018773|OTHER||Percent (%) ratio of geometric means|141.07|||||TWO_SIDED|90.0|103.79|191.73|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||191.73|103.79|
91565307|NCT03443063|183018773|OTHER||Percent (%) ratio of geometric means|124.48|||||TWO_SIDED|90.0|100.58|154.06|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||154.06|100.58|
91565308|NCT03443063|183018773|OTHER||Percent (%) ratio of geometric means|143.31|||||TWO_SIDED|90.0|107.72|190.65|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||190.65|107.72|
91565309|NCT03443063|183018773|OTHER||Percent (%) ratio of geometric means|140.2|||||TWO_SIDED|90.0|98.11|200.35|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||200.35|98.11|
91565310|NCT00552513|183018786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.15|TWO_SIDED|95.0|0.68|1.06|||Regression, Logistic|||||1.06|0.68|0.15
91565311|NCT00552513|183018787|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Regression, Logistic|||||0.89|0.58|0.003
91565312|NCT00552513|183018788|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.71|0.99|||Regression, Logistic|||||0.99|0.71|0.04
91565313|NCT02507687|183018795|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0231|TWO_SIDED|95.0|-1.03|-0.08|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||-0.08|-1.03|0.0231
91565314|NCT02507687|183018796|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1615|TWO_SIDED|95.0|-1.04|0.18|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.18|-1.04|0.1615
91565315|NCT02507687|183018797|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1673|TWO_SIDED|95.0|-0.97|0.17|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.17|-0.97|0.1673
91565316|NCT03619889|183018801|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91565317|NCT03619889|183018801|OTHER||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91565318|NCT03619889|183018808|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91565319|NCT03619889|183018808|OTHER||Mean Difference (Net)|-0.65|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91565320|NCT05012280|183018814|SUPERIORITY||Odds Ratio (OR)|1.221||||0.115|TWO_SIDED|95.0|0.953|1.564||only one primary endpoint, p value not adjusted for multiple comparisons. A priori treshold or statistical significance: p=0.05|Regression, Logistic|conditional logistic regression for matched case control||||1.564|0.953|0.1150
91565321|NCT05012280|183018814|SUPERIORITY||Odds Ratio (OR)|1.221||||0.12|TWO_SIDED|95.0|0.953|1.564|||Regression, Logistic|conditional logistic regression for matched case control study.||||1.564|0.953|0.12
91565322|NCT00871143|183018860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.001
91565323|NCT00871143|183018860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.001
91565324|NCT00871143|183018860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of Type 1 error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between between baseline and 1 month follow up||||< .001
91565325|NCT00871143|183018860|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.01
91565326|NCT00871143|183018860|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and 1 month follow up||||< 0.05
91565327|NCT00871143|183018861|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.05
91565328|NCT00871143|183018861|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week measures||||<0.01
91565329|NCT00871143|183018861|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were implemented to adjust for type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up.||||< 0.001
91565330|NCT00871143|183018861|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.||||>0.05
91565331|NCT00871143|183018861|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up measures.||||>0.05
91565332|NCT00871143|183018862|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.||||>0.05
91565333|NCT00871143|183018862|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||<0.01
91565334|NCT00871143|183018862|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferonni corrections used to reduce risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||>0.05
91565335|NCT00871143|183018862|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||>0.05
91565336|NCT00871143|183018862|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||> 0.05
91565337|NCT00871143|183018863|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.||||<0.05
91565338|NCT00871143|183018863|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were applied to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.001
91565339|NCT00871143|183018863|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||< 0.001
91565340|NCT00871143|183018863|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni Correction was used in an attempt to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.05
91565341|NCT00871143|183018863|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to adjust for type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||>0.05
91565342|NCT00871143|183018864|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.||||>0.05
91565343|NCT00871143|183018864|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||<0.05
91565344|NCT00871143|183018864|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
91565345|NCT00871143|183018864|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||>0.05
91565346|NCT00871143|183018864|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
91565347|NCT00871143|183018865|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.||||<0.05
91565348|NCT00871143|183018865|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||<0.01
91565349|NCT00871143|183018865|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were implemented to reduce the risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
91565350|NCT00871143|183018865|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||>0.05
91565351|NCT00871143|183018865|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
91565352|NCT00871143|183018866|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.||||<0.05
91565353|NCT00871143|183018866|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||<0.05
91565354|NCT00871143|183018866|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||< 0.05
91565355|NCT00871143|183018866|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||>0.05
91565356|NCT00871143|183018866|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||> 0.05
91565357|NCT03930238|183018869|SUPERIORITY||Group effect from Bayesian linear mixed|1646.0|||||TWO_SIDED|||||We did perform a Bayesian analysis which provided a posterior probability of 99.76% that the daily mean steps in the intervention group exceeded the daily mean steps in the comparison group.|Bayesian linear mixed effects regression||Posterior standard deviation = 578. We have 95% credible intervals - the interval that contains 95% of the posterior probability distribution of the parameter of interest - which ranges from 511 to 2781.|||||
91565358|NCT03930238|183018870|OTHER||Percentage|53.3|||||TWO_SIDED|||||||||||||
91565359|NCT03341312|183018884|SUPERIORITY||ratio of LS Means|0.75|||||TWO_SIDED|95.0|0.42|1.16||||||||1.16|0.42|
91565360|NCT03341312|183018884|SUPERIORITY||ratio of LS Means|0.74|||||TWO_SIDED|95.0|0.49|1.01||||||||1.01|0.49|
91565361|NCT01212952|183018888|OTHER||Maximum Tolerated Dose (MTD) (mg/m^2)|1.3|||||TWO_SIDED||||||||Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).|||||
91565362|NCT05372913|183018894|NON_INFERIORITY|The non-inferiority (NI) test for the secondary outcome (i.e., PHQ-8 Week 4 EOT score) was assessed using the pre-specified NI margin of 2.0. NI of W-GenZD to CBT-Lite was declared if the upper bound of the one-sided 97.5% confidence interval (CI) was less than 2.|Mean Difference (Net)|-0.67|||||TWO_SIDED|95.0|-2.3|0.96||||||||0.96|-2.30|
91565363|NCT05135156|183018896|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|3.0|25.0|||Regression, Linear||Difference = intervention - control|||25|3|0.02
91565364|NCT05135156|183018897|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.15|TWO_SIDED|95.0|-1.0|6.6|||Regression, Linear||Difference = intervention - control|||6.6|-1.0|0.15
91565365|NCT05135156|183018898|SUPERIORITY||Mean Difference (Net)|-1.2||||0.81|TWO_SIDED|95.0|-10.9|8.5|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||8.5|-10.9|0.81
91565366|NCT05135156|183018899|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.15|TWO_SIDED|95.0|-0.1|0.8|||Regression, Linear||Difference = intervention - control|||0.8|-0.1|0.15
91565367|NCT05135156|183018900|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.54|TWO_SIDED|95.0|-2.0|3.7|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.7|-2.0|0.54
91565368|NCT05135156|183018902|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.82|TWO_SIDED|95.0|-2.1|2.7|||Regression, Linear||Difference = intervention - control|||2.7|-2.1|0.82
91565369|NCT05135156|183018904|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.44|TWO_SIDED|95.0|-15.0|7.0|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||7|-15|0.44
91565370|NCT05135156|183018905|SUPERIORITY||Mean Difference (Net)|1.3||||0.31|TWO_SIDED|95.0|-1.3|3.9|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.9|-1.3|0.31
91565371|NCT05135156|183018906|SUPERIORITY||Mean Difference (Net)|5.0||||0.42|TWO_SIDED|95.0|-7.4|17.4|||Regression, Linear||Difference = intervention - control||Estimation parameter is regression parameter comparing intervention to control|17.4|-7.4|0.42
91565372|NCT05135156|183018907|OTHER|Pearson's chi-squared test of independence||||||0.39||||||p=0.39 at baseline, 0.39 at 2 weeks and 0.23 at 4 weeks|Chi-squared|||||||0.39
91565373|NCT05135156|183018908|SUPERIORITY||Mean Difference (Net)|0.05||||0.91|TWO_SIDED|95.0|-0.84|0.94|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit||0.94|-0.84|0.91
91565374|NCT05135156|183018908|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.16|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visit||0.16|-0.08|0.53
91565375|NCT05135156|183018908|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.4|-0.3|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Decisional Conflict Scale from baseline to 2-week study visit||-0.3|-8.4|0.04
91565376|NCT05135156|183018908|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.74|TWO_SIDED|95.0|-3.6|5.0||Outcome = mean PrepDM Scale at 2-weeks|Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|||5.0|-3.6|0.74
91565377|NCT02389725|183018917|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
91565378|NCT02389725|183018918|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
91565379|NCT02389725|183018919|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
91565380|NCT02389725|183018920|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
91565381|NCT00404547|183018921|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.||||<0.0001
91565382|NCT00475735|183018930|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.341
91565383|NCT00475735|183018930|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.001
91565384|NCT01187407|183018938|SUPERIORITY_OR_OTHER|||||||0.997||||||Primary comparison.|Mixed Models Analysis|||||||0.997
91565385|NCT01187407|183018938|SUPERIORITY_OR_OTHER|||||||0.769||||||Secondary comparison.|Mixed Models Analysis|||||||0.769
91565386|NCT00125853|183018980|OTHER|"Linear Mixed effect Modelling, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) = 0.05 (0.09)"||||||0.6|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on ISI||||0.60
91565387|NCT00125853|183018981|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -2.59 (1.34)"||||||0.06|||||||Linear Mixed effect Model, adjusted for|||Comparing treatment effects on ABPM||||0.06
91565388|NCT00125853|183018982|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0/09 (0.14)"||||||0.51|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on total cholesterol||||0.51
91565389|NCT00125853|183018983|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) =0.02 (0.03)"||||||0.48|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on HbA1c||||0.48
91565390|NCT00125853|183018984|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0.21(0.13)"||||||0.09|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on BMI||||0.09
91565391|NCT02350127|183018985|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|1.22||0.14|TWO_SIDED|95.0|-0.59|4.18|||Mixed Models Analysis|||adjusted for participant baseline MOCA, robust VCE||4.18|-0.59|0.14
91565392|NCT02350127|183018985|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.4||0.03|TWO_SIDED|95.0|0.2|5.6|||Mixed Models Analysis|||restricted to completers||5.6|0.2|0.03
91565393|NCT02350127|183018986|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.52||0.68|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||Adjusting for baseline participant MOCA scores, robust vce.|||0.80|-1.23|0.68
91565394|NCT02350127|183018987|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.32||0.7|TWO_SIDED|95.0|-3.09|2.08|||Mixed Models Analysis|||adjusting for baseline participant MOCA, robust VCE||2.08|-3.09|0.70
91565395|NCT02350127|183018988|SUPERIORITY||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|2.2||0.02|TWO_SIDED|95.0|0.8|9.4|||Mixed Models Analysis|||||9.4|0.8|0.02
91565396|NCT02350127|183018989|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.3||0.47|TWO_SIDED|95.0|-5.4|11.6|||Mixed Models Analysis|||||11.6|-5.4|0.47
91565397|NCT02350127|183018990|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.99|TWO_SIDED|95.0|-1.1|1.1|||Mixed Models Analysis|||||1.1|-1.1|0.99
91565398|NCT02350127|183018991|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.7||0.98|TWO_SIDED|95.0|-7.4|7.2|||Mixed Models Analysis|||||7.2|-7.4|0.98
91565399|NCT02350127|183018992|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.5||0.8|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||||3.3|-2.5|0.80
91565400|NCT02350127|183018993|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.1||0.38|TWO_SIDED|95.0|-3.1|1.2|||Mixed Models Analysis|||||1.2|-3.1|0.38
91565401|NCT02350127|183018994|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.45||0.075|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.075
91565402|NCT02350127|183018995|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.7||0.35|TWO_SIDED|95.0|-1.7|5.0|||Mixed Models Analysis|||||5.0|-1.7|0.35
91565403|NCT02350127|183018996|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.35|TWO_SIDED|95.0|-6.1|2.1|||Mixed Models Analysis|||||2.1|-6.1|0.35
91565404|NCT02350127|183018997|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.54|TWO_SIDED|95.0|-0.4|0.8|||Mixed Models Analysis|||||0.8|-0.4|0.54
91565405|NCT02350127|183018998|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.69|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|||||2.2|-1.5|0.69
91565406|NCT02350127|183018999|SUPERIORITY||Median Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.2||0.88|TWO_SIDED|95.0|-10.9|9.3|||Mixed Models Analysis|||||9.3|-10.9|0.88
91565407|NCT02350127|183019000|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.26|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.26
91565408|NCT02350127|183019001|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.1||0.08|TWO_SIDED|95.0|-3.9|0.2|||Mixed Models Analysis|||||0.2|-3.9|0.08
91565409|NCT00157209|183019004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.745||||0.045|TWO_SIDED|95.0|0.533|1.042|||Log Rank|||||1.042|0.533|0.045
91565410|NCT00024102|183019010|NON_INFERIORITY_OR_EQUIVALENCE|The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)|Hazard Ratio (HR)|2.09|||<|0.001|TWO_SIDED|95.0|1.38|3.17||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones|Regression, Cox|||||3.17|1.38|<0.001
91565411|NCT00024102|183019011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.02|TWO_SIDED|95.0|1.11|3.08||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.|Regression, Cox|||||3.08|1.11|0.02
91565412|NCT03418701|183019085|SUPERIORITY||Mean Difference (Final Values)|2.67|||<|0.05|TWO_SIDED|95.0|0.93|4.4|||t-test, 2 sided|||||4.40|0.93|<0.05
91565413|NCT03418701|183019086|SUPERIORITY||Odds Ratio, log|0.47|||<|0.05|TWO_SIDED|95.0|0.22|1.15|||Mixed Models Analysis|A multilevel logistic regression with participants nested within clinic.||||1.15|0.22|<0.05
91565414|NCT04754594|183019096|OTHER||Geometric mean ratio|0.67|||||TWO_SIDED|95.0|0.5|0.9||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||0.90|0.50|
91565415|NCT04754594|183019097|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|95.0|0.91|1.77||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.77|0.91|
91565416|NCT04754594|183019097|OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.69|1.3||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.30|0.69|
91565417|NCT04754594|183019098|OTHER|Vaccine efficacy was estimated by 100\*(1 - illness rate ratio \[IRR\]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|3.8|||||TWO_SIDED|95.0|-1227.8|93.0||||||||93.0|-1227.8|
91565418|NCT04754594|183019099|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|35.1|||||TWO_SIDED|95.0|-466.5|94.6||||||||94.6|-466.5|
91565419|NCT04754594|183019100|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|40.9|||||TWO_SIDED|95.0|-104.9|86.5||||||||86.5|-104.9|
91565420|NCT00577096|183019129|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.||||<0.025
91565421|NCT00577096|183019130|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.||||<0.025
91565422|NCT00577096|183019131|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared test to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|Analysis included short and long term participants.||||||<0.025
91565423|NCT00577096|183019132|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
91565424|NCT00577096|183019133|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||||||<0.025
91565425|NCT00577096|183019134|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.||||<0.025
91565426|NCT00577096|183019135|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
91565427|NCT00577096|183019136|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
91565428|NCT00577096|183019137|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
91565429|NCT00832650|183019139|SUPERIORITY_OR_OTHER||LS Mean difference|0.051|||||TWO_SIDED|95.0|-0.334|0.436|||ANCOVA||Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.|Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.||0.436|-0.334|
91565430|NCT04382053|183019207|SUPERIORITY||Least squares mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.297||0.467|TWO_SIDED|90.0|-2.0|2.3|||ANCOVA|||||2.3|-2.0|0.467
91565431|NCT04382053|183019208|SUPERIORITY|||||||0.237||||||One-sided|Mixed Models Analysis|p-value reported is for the treatment factor across all time points||||||0.237
91565432|NCT04572997|183019293|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-rank test||||||< 0.0001
91565433|NCT04572997|183019298|OTHER||||||<|0.001|||||||Wilcoxon Signed-rank test|||||||< 0.001
91565434|NCT00275301|183019344|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.||||<0.05
91565435|NCT04357964|183019345|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups at baseline in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.|||||<|0.01||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||<0.01
91565436|NCT04357964|183019346|EQUIVALENCE|Statistical significance was defined as p \< 0.05. There was no intervention in this study, so there is no true equivalence margin.|||||<|0.01|||||||Pearson correlation|||||||<0.01
91565437|NCT04357964|183019347|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.||||||0.52||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||0.52
91565438|NCT00733226|183019348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.52||0.05|TWO_SIDED|95.0|-3.2|-1.1||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The sample size was computed to prove that a 30% decrease of the rate of virus provoked wheezing attacks in the OM-85 group compared with placebo is statistically significant. Approximately 29 analyzable participants in each group were required, with α=0.05 and β=0.10 (ie, with a power of 90%), respectively. The difference of 30% was taken from both pilot study and clinical experience. Sample size estimation was performed by using NCSS and PASS 2000 software.||-1.10|-3.20|0.05
91565439|NCT00733226|183019349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-3.06|-1.01||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||-1.01|-3.06|<0.001
91565440|NCT00733226|183019350|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.94|-1.27|||Wilcoxon (Mann-Whitney)|P value was not need to adjusted for multiple comparisons||||-1.27|-2.94|<0.001
91565441|NCT00733226|183019351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|-0.77|0.11||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.11|-0.77|0.110
91565442|NCT00733226|183019352|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14||0.195|TWO_SIDED|95.0|-0.55|0.03||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.03|-0.55|0.195
91565443|NCT00733226|183019353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.82||0.452|TWO_SIDED|95.0|-2.87|0.42||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.42|-2.87|0.452
91565444|NCT01540162|183019355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||0.05|TWO_SIDED|95.0|0.05|0.73|||Chi-squared|||||0.73|0.05|0.05
91565445|NCT02288364|183019360|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Chi-squared|||||||0.30
91565446|NCT02288364|183019361|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Chi-squared|||||||0.08
91565447|NCT02288364|183019362|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Chi-squared|||||||0.29
91565448|NCT00821119|183019384|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||"Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.~The analysis was performed according to the intention-to-treat principle."||1.14|0.48|<0.05
91565449|NCT00821119|183019385|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16||0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||1.14|0.48|0.05
91565450|NCT00821119|183019386|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|0.62|1.78|||risk ratio (RR)|||The study was not powered for this outcome. However this analysis was done with this limitation||1.78|0.62|< 0.05
91565451|NCT03511378|183019387|NON_INFERIORITY|Non-inferiority was assessed using a margin of -0.10|Difference in proportions|-0.0296||||0.007|ONE_SIDED|95.0|-0.076||||Difference in proportion|Binomial proportion used to present difference in proportion in treatments||Analysis population : ITT|||-0.076|0.007
91565452|NCT03511378|183019388|NON_INFERIORITY|Noninferiority is assessed using a margin of 10 percentage points.|Difference in proportions|0.0145|||<|0.001|ONE_SIDED|95.0|-0.0092||||Difference in proportion||Difference of proportion analysed with one sided 95% confidence interval|Analysis population: ITT|||-0.0092|<0.001
91565453|NCT03009019|183019407|SUPERIORITY||Odds Ratio (OR)|1.4||||0.075|TWO_SIDED|95.0|0.97|2.03|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.03|0.97|0.075
91565454|NCT03009019|183019407|SUPERIORITY||Odds Ratio (OR)|1.47||||0.055|TWO_SIDED|95.0|1.0|2.14|||Fisher Exact|||Observed cases (OC)||2.14|1.00|0.055
91565455|NCT03009019|183019408|SUPERIORITY||Odds Ratio (OR)|1.75||||0.003|TWO_SIDED|95.0|1.22|2.52|||Regression, Logistic|||||2.52|1.22|0.003
91565456|NCT03009019|183019408|SUPERIORITY||Odds Ratio (OR)|1.76||||0.003|TWO_SIDED|95.0|1.22|2.55|||Regression, Logistic|||||2.55|1.22|0.003
91565457|NCT01812707|183019430|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 75 mg Q2W versus placebo~3. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||<0.0001
91565458|NCT01812707|183019430|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
91565459|NCT01812707|183019430|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
91565460|NCT01697592|183019442|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.93|||<|0.001|TWO_SIDED|95.0|-1.1|-0.75|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.75|-1.10|<0.001
91565461|NCT01697592|183019442|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.37|-0.6|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.60|-1.37|<0.001
91565462|NCT01697592|183019442|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.92|||<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.56|-1.29|<0.001
91565463|NCT01697592|183019442|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.45|-0.88|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.88|-1.45|<0.001
91565464|NCT01697592|183019442|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.06|-0.54|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.54|-1.06|<0.001
91565465|NCT03861429|183019518|SUPERIORITY||Odds Ratio (OR)|3.32||||0.105|TWO_SIDED|95.0|0.78|14.15|||Mixed Models Analysis|||Multilevel logistic regression (generalized estimating equations \[GEE\] with an autoregressive (1) working correlation matrix, logit link function) were fitted to assess the primary hypotheses. The models account for the repeated measures (3 or 4 time points), correlated, data structure per person. An additive model was conducted with contrast coding for each time point, treatment, and follow-up effects.||14.15|.78|.105
91565466|NCT03861429|183019519|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.022|1.178|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||1.178|.022|.04
91565467|NCT03861429|183019520|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.001|TWO_SIDED|95.0|0.12|0.46|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.46|.12|.001
91565468|NCT03861429|183019521|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.001|TWO_SIDED|95.0|0.21|0.48|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.48|.21|.001
91565469|NCT03861429|183019522|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.081|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||||.19|-.01|.081
91565470|NCT03861429|183019523|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.033|TWO_SIDED|95.0|0.11|0.3|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.3|.11|.033
91565471|NCT01763346|183019528|SUPERIORITY|||||||0.05||||||35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.|General Linear Models|Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.||We selected a sample size that would allow detection of an effect size of \~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.||||0.05
91565472|NCT01797822|183019532|OTHER|Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P\<0.05) in change in corneal staining pre and post low humidity challenge.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
91565473|NCT00396097|183019613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.033||0.5762|ONE_SIDED|97.5|-0.071||||ANCOVA|||The null hypothesis was that the individualized treatment arm was not superior to the standard treatment arm; alternative hypothesis that the individualized treatment arm was superior to the standard treatment arm with respect to the mean 24-month AOTD. Using a 2:1 randomization, a two sided sample t-test comparing the root AOTD between the 2 treatment arms with 80% power at a 5% level required 260 subjects. Assuming a 20% attrition rate, approximately 312 subjects were needed for this study.|||-0.071|0.5762
91565474|NCT00396097|183019614|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||ANOVA (Levene's Test)|||||||0.627
91565475|NCT00396097|183019615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.8016|TWO_SIDED|95.0|0.802|1.33|||Regression, Cox|||||1.330|0.802|0.8016
91565476|NCT00396097|183019616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.822|STANDARD_ERROR_OF_MEAN|2.25||0.0101|TWO_SIDED|95.0|1.395|10.249|||ANCOVA|||||10.249|1.395|0.0101
91565477|NCT00396097|183019616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.281|STANDARD_ERROR_OF_MEAN|2.471||0.0002|TWO_SIDED|95.0|4.417|14.145|||ANCOVA|||||14.145|4.417|0.0002
91565478|NCT00396097|183019616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.204|STANDARD_ERROR_OF_MEAN|2.495||0.2001|TWO_SIDED|95.0|-1.707|8.114|||ANCOVA|||||8.114|-1.707|0.2001
91565479|NCT00396097|183019617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.899|STANDARD_ERROR_OF_MEAN|3.414|<|0.0001|TWO_SIDED|95.0|30.181|43.618|||ANCOVA|||||43.618|30.181|<0.0001
91565480|NCT00396097|183019617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.517|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|42.054|54.98|||ANCOVA|||||54.980|42.054|<.0001
91565481|NCT00396097|183019617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.443|STANDARD_ERROR_OF_MEAN|3.306|<|0.0001|TWO_SIDED|95.0|27.936|40.951|||ANCOVA|||||40.951|27.936|<.0001
91565482|NCT00396097|183019618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.081||0.2618|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|||||0.249|-0.068|0.2618
91565483|NCT00396097|183019618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.094||0.8926|TWO_SIDED|95.0|-0.172|0.198|||ANCOVA|||||0.198|-0.172|0.8926
91565484|NCT00396097|183019618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.095||0.9566|TWO_SIDED|95.0|-0.192|0.181|||ANCOVA|||||0.181|-0.192|0.9566
91565485|NCT03209050|183019619|OTHER|||||||0.5|||||||Clopper-Pearson 95% CI|||||||0.5
91565486|NCT02642159|183019633|SUPERIORITY||LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|97.5|-38.1|-27.0||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Alirocumab group was compared to usual care group using an appropriate contrast statement.||-27.0|-38.1|<0.0001
91565487|NCT02642159|183019634|SUPERIORITY||LS Mean Difference|-33.3|||<|0.0001|TWO_SIDED|97.5|-46.6|-19.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.||-19.9|-46.6|<0.0001
91565488|NCT02642159|183019635|SUPERIORITY||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.7|-36.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-36.3|-49.7|<0.0001
91565489|NCT02642159|183019636|SUPERIORITY||LS Mean Difference|-55.7|||<|0.0001|TWO_SIDED|97.5|-71.8|-39.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-39.6|-71.8|<0.0001
91565490|NCT02642159|183019637|SUPERIORITY||LS Mean Difference|-26.1|||<|0.0001|TWO_SIDED|97.5|-31.5|-20.7||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.7|-31.5|<0.0001
91565491|NCT02642159|183019638|SUPERIORITY||LS Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-40.0|-14.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-14.8|-40.0|<0.0001
91565492|NCT02642159|183019639|SUPERIORITY||LS Mean Difference|-34.7|||<|0.0001|TWO_SIDED|97.5|-40.8|-28.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-28.6|-40.8|<0.0001
91565493|NCT02642159|183019640|SUPERIORITY||LS Mean Difference|-49.7|||<|0.0001|TWO_SIDED|97.5|-63.7|-35.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-35.8|-63.7|<0.0001
91565494|NCT02642159|183019641|SUPERIORITY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|97.5|-37.3|-27.2||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-27.2|-37.3|<0.0001
91565495|NCT02642159|183019642|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|97.5|-47.4|-22.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-22.9|-47.4|<0.0001
91565496|NCT02642159|183019643|SUPERIORITY||LS Mean Difference|-24.6|||<|0.0001|TWO_SIDED|97.5|-28.8|-20.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.3|-28.8|<0.0001
91565497|NCT02642159|183019644|SUPERIORITY||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|97.5|-35.4|-15.1||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-15.1|-35.4|<0.0001
91565498|NCT02642159|183019645|SUPERIORITY||Adjusted Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-34.6|-20.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.1|-34.6|<0.0001
91565499|NCT02642159|183019646|SUPERIORITY||Adjusted Mean Difference|-22.8||||0.004|TWO_SIDED|97.5|-40.6|-5.0||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-5.0|-40.6|0.0040
91565500|NCT02642159|183019647|SUPERIORITY||Adjusted Mean Difference|-4.2||||0.2191|TWO_SIDED|97.5|-11.8|3.4||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||3.4|-11.8|0.2191
91565501|NCT02642159|183019648|SUPERIORITY||Adjusted Mean Difference|9.0||||0.2651|TWO_SIDED|97.5|-9.1|27.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|27.1|-9.1|0.2651
91565502|NCT02864147|183019666|SUPERIORITY|||||||0.043||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.043
91565503|NCT02864147|183019666|SUPERIORITY|||||||0.384||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.384
91565504|NCT02864147|183019667|SUPERIORITY|||||||0.177||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.177
91565505|NCT02864147|183019667|SUPERIORITY|||||||0.592||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.592
91565506|NCT02269917|183019668|NON_INFERIORITY|4|Difference in percentage|0.4|||<|0.001|TWO_SIDED|95.0|-1.5|2.2|||Stratum-adjusted Mantel-Haenszel (MH)|||||2.2|-1.5|<0.001
91565507|NCT02269917|183019673|OTHER||Least Square (LS) Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.623|=|0.58|TWO_SIDED|95.0|-0.88|1.57|||ANCOVA|||Change at Week 24||1.57|-0.88|=0.580
91565508|NCT02269917|183019673|OTHER||Least Square (LS) Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.646|=|0.34|TWO_SIDED|95.0|-0.65|1.88|||ANCOVA|||Change at Week 48||1.88|-0.65|=0.340
91565509|NCT02269917|183019674|OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.874|=|0.506|TWO_SIDED|95.0|-2.3|1.13|||ANCOVA|||Change at Week 24||1.13|-2.30|=0.506
91565510|NCT02269917|183019674|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.862|=|0.392|TWO_SIDED|95.0|-2.43|0.95|||ANCOVA|||Change Week 48||0.95|-2.43|=0.392
91565511|NCT02269917|183019675|OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.624|=|0.143|TWO_SIDED|95.0|-2.14|0.31|||ANCOVA|||Change at Week 24||0.31|-2.14|=0.143
91565512|NCT02269917|183019675|OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.646|=|0.092|TWO_SIDED|95.0|-2.36|0.18|||ANCOVA|||Change at Week 48||0.18|-2.36|=0.092
91565513|NCT02269917|183019676|OTHER||LS Mean Difference|1.14|STANDARD_ERROR_OF_MEAN|0.59|=|0.054|TWO_SIDED|95.0|-0.02|2.29|||ANCOVA|||Change at Week 24||2.29|-0.02|=0.054
91565514|NCT02269917|183019676|OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.63|=|0.034|TWO_SIDED|95.0|0.1|2.57|||ANCOVA|||Change at Week 48||2.57|0.10|=0.034
91565515|NCT02269917|183019677|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 24||||<0.001
91565516|NCT02269917|183019677|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 48||||<0.001
91565517|NCT02269917|183019677|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 24||||<0.001
91565518|NCT02269917|183019677|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 48||||<0.001
91565519|NCT02269917|183019678|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 24||||<0.001
91565520|NCT02269917|183019678|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 48||||<0.001
91565521|NCT02269917|183019678|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 24||||<0.001
91565522|NCT02269917|183019678|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 48||||<0.001
91565523|NCT02269917|183019679|OTHER||||||=|0.288|||||||Van Elteren Test|||FEPO4 - Change at Week 24||||=0.288
91565524|NCT02269917|183019679|OTHER||||||=|0.148|||||||Van Elteren Test|||FEPO4 - Change at Week 48||||=0.148
91565525|NCT02269917|183019690|OTHER||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.697|2.037|||ANCOVA|||Spine BMD: Percent change at Week 24||2.037|0.697|<0.001
91565526|NCT02269917|183019690|OTHER||LS Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.277|2.814|||ANCOVA|||Spine BMD: Percent change at Week 48||2.814|1.277|<0.001
91565527|NCT02269917|183019690|OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.272|=|0.001|TWO_SIDED|95.0|0.366|1.436|||ANCOVA|||Hip BMD: Percent change at Week 24||1.436|0.366|=0.001
91565528|NCT02269917|183019690|OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|1.144|2.248|||ANCOVA|||Hip BMD: Percent change at Week 48||2.248|1.144|<0.001
91565529|NCT01770509|183019725|SUPERIORITY_OR_OTHER|||||||0.652|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.652
91565530|NCT01770509|183019726|SUPERIORITY_OR_OTHER|||||||0.645|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.645
91565531|NCT00985621|183019748|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.44|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.44|-1.49|<0.001
91565532|NCT00985621|183019748|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.50|<0.001
91565533|NCT00985621|183019749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.45|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.45|-1.49|<0.001
91565534|NCT00985621|183019749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.27||0.018|TWO_SIDED|95.0|-1.16|-0.11|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.11|-1.16|0.018
91565535|NCT00985621|183019749|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.7|TWO_SIDED|95.0|-0.43|0.65|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.65|-0.43|0.700
91565536|NCT00985621|183019750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.177|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.14|-0.78|0.177
91565537|NCT00985621|183019750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.24||0.416|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.28|-0.66|0.416
91565538|NCT00985621|183019750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.46|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.46|-1.50|<0.001
91565539|NCT00985621|183019750|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.48|-0.43|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.48|<0.001
91565540|NCT00985621|183019751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.319|TWO_SIDED|95.0|-0.69|0.22|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.22|-0.69|0.319
91565541|NCT00985621|183019751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.23||0.916|TWO_SIDED|95.0|-0.43|0.48|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.48|-0.43|0.916
91565542|NCT00985621|183019751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.526|TWO_SIDED|95.0|-0.63|0.32|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.32|-0.63|0.526
91565543|NCT00985621|183019751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.26||0.004|TWO_SIDED|95.0|-1.26|-0.24|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.24|-1.26|0.004
91565544|NCT00985621|183019751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.26||0.134|TWO_SIDED|95.0|-0.9|0.12|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.12|-0.90|0.134
91565545|NCT00985621|183019751|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.27||0.497|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.35|-0.71|0.497
91565546|NCT02418819|183019837|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-1.9|STANDARD_ERROR_OF_MEAN|2.032||0.8243|ONE_SIDED|92.0|-4.78||||ANCOVA|One(1)-sided P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-4.78|0.8243
91565547|NCT02418819|183019837|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-2.14|STANDARD_ERROR_OF_MEAN|2.252||0.8277|ONE_SIDED|92.0|-5.33||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-5.33|0.8277
91565548|NCT02418819|183019837|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-4.01|STANDARD_ERROR_OF_MEAN|1.902||0.981|ONE_SIDED|92.0|-6.7||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-6.70|0.9810
91565549|NCT02418819|183019838|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0129|STANDARD_ERROR_OF_MEAN|0.286||0.4821|ONE_SIDED|99.0|-0.6682||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.6682|0.4821
91565550|NCT02418819|183019838|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-0.2974|STANDARD_ERROR_OF_MEAN|0.276||0.8576|ONE_SIDED|99.0|-0.9547||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.9547|0.8576
91565551|NCT02418819|183019838|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0498|STANDARD_ERROR_OF_MEAN|0.2403||0.4182|ONE_SIDED|99.0|-0.5226||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.5226|0.4182
91565552|NCT01332318|183019841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.08|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 2 minus Arm 1.|||0.42|0.08|
91565553|NCT01332318|183019841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.41|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 3 minus Arm 1.|||0.41|0.09|
91565554|NCT01332318|183019841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 4 minus Arm 1.|||0.42|0.09|
91565555|NCT00676663|183019877|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.06|TWO_SIDED|95.0|0.49|1.09|||Log Rank|P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.||||1.09|0.49|0.06
91565556|NCT00676663|183019881|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.018|TWO_SIDED|95.0|0.36|0.97||P-value is stratified by the randomization stratification factors and is 1-sided.|Log Rank||Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.|||0.97|0.36|0.018
91565557|NCT02168153|183019884|SUPERIORITY||Mean Difference (Final Values)|-3.49||||0.76|TWO_SIDED|95.0|-25.75|18.77|||ANCOVA|adjusted for age||Between group differences||18.77|-25.75|0.76
91565558|NCT02168153|183019885|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.92|TWO_SIDED|95.0|-18.04|19.98|||ANCOVA|adjusted for age||Between group differences||19.98|-18.04|0.92
91565559|NCT02168153|183019886|SUPERIORITY||Mean Difference (Final Values)|3.49||||0.7|TWO_SIDED|95.0|-14.4|21.39|||ANCOVA|adjusted for age||Between group differences||21.39|-14.4|0.70
91565560|NCT02168153|183019887|SUPERIORITY||Mean Difference (Final Values)|0.988||||0.15|TWO_SIDED|95.0|-0.373|2.349|||ANCOVA|adjusted for age||Between group differences||2.349|-0.373|0.15
91565561|NCT02168153|183019888|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.32|TWO_SIDED|95.0|-1.24|0.41|||ANCOVA|adjusted for age||Between group differences||0.41|-1.24|0.32
91565562|NCT00513292|183019893|SUPERIORITY_OR_OTHER||difference in percentages between arms|2.3||||0.7|TWO_SIDED|95.0|-9.3|13.9|||Chi-squared|||The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy||13.9|-9.3|.7
91565563|NCT00714688|183019911|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-2.7|STANDARD_ERROR_OF_MEAN|1.51||0.136||95.0|-6.04|0.67||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||0.67|-6.04|0.136
91565564|NCT00714688|183019911|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.9|STANDARD_ERROR_OF_MEAN|1.5||0.002||95.0|-8.22|-1.55||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||-1.55|-8.22|0.002
91565565|NCT00714688|183019912|SUPERIORITY_OR_OTHER|||||||0.216||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model was performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.216
91565566|NCT00714688|183019912|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||<0.001
91565567|NCT00714688|183019913|SUPERIORITY_OR_OTHER|||||||0.052||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.052
91565568|NCT00714688|183019913|SUPERIORITY_OR_OTHER|||||||0.002||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.002
91565569|NCT00714688|183019914|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.2|STANDARD_ERROR_OF_MEAN|1.86||0.023||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.023
91565570|NCT00714688|183019914|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.4|STANDARD_ERROR_OF_MEAN|1.83||0.016||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.016
91565571|NCT00318591|183019918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.|Hazard Ratio (HR)|1.502||||0.0383|TWO_SIDED|95.0|1.022|2.207||p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.|Kaplan-Meier|||The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.||2.207|1.022|0.0383
91565572|NCT00318591|183019920|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA analysis. Limit of significant difference \<0.05||||||0.767||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.7670
91565573|NCT00318591|183019921|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA. Level of significant difference \<0.05||||||0.0074||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.0074
91565574|NCT01524887|183019925|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.4||||0.243||95.0|-1.0|3.9|||Mixed Models Analysis|||||3.9|-1.0|0.243
91565575|NCT01524887|183019925|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.0||||0.37||95.0|-1.2|3.3|||Mixed Models Analysis|||||3.3|-1.2|0.370
91565576|NCT01524887|183019926|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-3.9||||0.033||95.0|-7.4|-0.3|||Mixed Models Analysis|||||-0.3|-7.4|0.033
91565577|NCT01524887|183019926|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.9||||0.586||95.0|-4.2|2.4|||Mixed Models Analysis|||||2.4|-4.2|0.586
91565578|NCT01524887|183019927|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.2||||0.501||95.0|-1.0|0.5|||Mixed Models Analysis|||||0.5|-1.0|0.501
91565579|NCT01524887|183019927|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.1||||0.783||95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.783
91565580|NCT01524887|183019928|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.1||||0.571||95.0|-2.6|4.7|||Mixed Models Analysis|||||4.7|-2.6|0.571
91565581|NCT01524887|183019928|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|3.7||||0.032||95.0|0.3|7.1|||Mixed Models Analysis|||||7.1|0.3|0.032
91565582|NCT01524887|183019929|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.00026||||0.593||95.0|-0.00126|0.00073|||ANCOVA|||||0.00073|-0.00126|0.593
91565583|NCT01524887|183019929|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.00003||||0.94||95.0|-0.0008|0.00086|||ANCOVA|||||0.00086|-0.00080|0.940
91565584|NCT01524887|183019930|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.5||||0.633||95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.633
91565585|NCT01524887|183019930|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.0||||0.981||95.0|-2.0|2.0|||Mixed Models Analysis|||||2.0|-2.0|0.981
91565586|NCT01967719|183019941|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|56.57|||||TWO_SIDED|95.0|44.21|72.39|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||72.39|44.21|
91565587|NCT01967719|183019942|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|55.64|||||TWO_SIDED|95.0|43.3|71.5|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||71.50|43.30|
91565588|NCT02229396|183019972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.129||0.003|TWO_SIDED|95.0|-0.63|-0.13|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.13|-0.63|0.003
91565589|NCT02229396|183019972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.84|-0.34|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.34|-0.84|<0.001
91565590|NCT02229396|183019973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.406|<|0.001|TWO_SIDED|95.0|-2.79|-1.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-1.20|-2.79|<0.001
91565591|NCT02229396|183019973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.12|-0.55|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.55|-2.12|<0.001
91565592|NCT02229396|183019974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.08|STANDARD_ERROR_OF_MEAN|4.007|<|0.001|TWO_SIDED|95.0|-27.95|-12.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-12.20|-27.95|<0.001
91565593|NCT02229396|183019974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.64|STANDARD_ERROR_OF_MEAN|3.947|<|0.001|TWO_SIDED|95.0|-24.39|-8.89|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.89|-24.39|<0.001
91565594|NCT02229396|183019975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.74|STANDARD_ERROR_OF_MEAN|5.168|<|0.001|TWO_SIDED|95.0|-37.89|-17.59|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-17.59|-37.89|<0.001
91565595|NCT02229396|183019975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.78|STANDARD_ERROR_OF_MEAN|5.09|<|0.001|TWO_SIDED|95.0|-36.78|-16.78|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-16.78|-36.78|<0.001
91565596|NCT02229396|183019976|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
91565597|NCT02229396|183019976|SUPERIORITY_OR_OTHER||Difference in percentages|13.3||||0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||0.001
91565598|NCT02229396|183019977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.26|STANDARD_ERROR_OF_MEAN|3.494|<|0.001|TWO_SIDED|95.0|-27.12|-13.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-13.40|-27.12|<0.001
91565599|NCT02229396|183019977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.03|STANDARD_ERROR_OF_MEAN|3.477|<|0.001|TWO_SIDED|95.0|-21.85|-8.2||This is a nominal p-value.|Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.20|-21.85|<0.001
91565600|NCT02229396|183019978|SUPERIORITY_OR_OTHER||Difference in percentages|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
91565601|NCT02229396|183019978|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
91565602|NCT02229396|183019979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.08||0.005|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.9|-5.2|0.005
91565603|NCT02229396|183019979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.06||0.022|TWO_SIDED|95.0|-4.5|-0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.4|-4.5|0.022
91565604|NCT02679079|183019986|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|2.1||0.89|TWO_SIDED|95.0|-4.4|3.8||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||3.8|-4.4|0.89
91565605|NCT02679079|183019986|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|2.1||0.47|TWO_SIDED|95.0|-2.6|5.6||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||5.6|-2.6|0.47
91565606|NCT02679079|183019987|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.21|TWO_SIDED|95.0|-1.0|0.2||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.2|-1.0|0.21
91565607|NCT02679079|183019987|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.67|TWO_SIDED|95.0|-0.5|0.8||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.8|-0.5|0.67
91565608|NCT02679079|183019988|SUPERIORITY||Risk Difference (RD)|13.9||||0.24|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years)|Risk difference expressed as percentage.|||||0.24
91565609|NCT02679079|183019988|SUPERIORITY||Risk Difference (RD)|-4.5||||0.71|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.71
91565610|NCT02679079|183019989|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.9||0.52|TWO_SIDED|95.0|-7.7|3.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.9|-7.7|0.52
91565611|NCT02679079|183019989|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|2.9||0.64|TWO_SIDED|95.0|-4.5|7.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||7.2|-4.5|0.64
91565612|NCT02679079|183019990|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|4.5||0.6|TWO_SIDED|95.0|-11.2|6.5||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||6.5|-11.2|0.60
91565613|NCT02679079|183019990|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|4.5||0.54|TWO_SIDED|95.0|-6.1|11.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||11.7|-6.1|0.54
91565614|NCT02679079|183019991|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.64|TWO_SIDED|95.0|-2.6|1.6||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.6|-2.6|0.64
91565615|NCT02679079|183019991|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|95.0|-2.5|1.9||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.9|-2.5|0.77
91565616|NCT02679079|183019992|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-1.4|3.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.2|-1.4|0.45
91565617|NCT02679079|183019992|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.2||0.72|TWO_SIDED|95.0|-2.7|1.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.9|-2.7|0.72
91565618|NCT02679079|183019993|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.41|TWO_SIDED|95.0|-0.3|0.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||0.7|-0.3|0.41
91565619|NCT02679079|183019993|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|0.2|1.1||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.1|0.2|0.01
91565620|NCT02679079|183019994|SUPERIORITY||Risk Difference (RD)|14.8||||0.18|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.18
91565621|NCT02679079|183019994|SUPERIORITY||Risk Difference (RD)|-0.7||||0.95|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.95
91565622|NCT01066897|183020015|OTHER|||||||0.002|||||||Chi-squared|||||||.002
91565623|NCT01066897|183020016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.368|STANDARD_DEVIATION|0.44||0.067|TWO_SIDED||||||t-test, 2 sided|One sample t-test to determine if the % change in HAMD was different from 0||For the 2 dropouts, used LOCF.||||.067
91565624|NCT00265096|183020026|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided \>98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.||||<0.001
91565625|NCT00265096|183020026|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
91565626|NCT00265096|183020026|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
91565627|NCT00265096|183020027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
91565628|NCT00265096|183020027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
91565629|NCT00265096|183020027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
91565630|NCT00265096|183020028|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline Methotrexate (MTX) usage)||||||<0.001
91565631|NCT00265096|183020028|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
91565632|NCT00265096|183020028|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
91565633|NCT00265096|183020029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline Methotrexate (MTX) usage)||||||<0.001
91565634|NCT00265096|183020029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (with treatment and subject's baseline MTX usage)||||||<0.001
91565635|NCT00265096|183020029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline MTX usage)||||||<0.001
91565636|NCT00265096|183020030|SUPERIORITY_OR_OTHER|||||||0.015||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant.|ANOVA|Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage||Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided \>93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX||||0.015
91565637|NCT00265096|183020030|SUPERIORITY_OR_OTHER|||||||0.011||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.011
91565638|NCT00265096|183020030|SUPERIORITY_OR_OTHER|||||||0.086||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.086
91565639|NCT00265096|183020031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)||||||<0.001
91565640|NCT00265096|183020031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
91565641|NCT00265096|183020031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
91565642|NCT00666835|183020043|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Point estimate of difference (ANCOVA)|0.084|||||TWO_SIDED|95.0|-0.17|0.338||||||||0.338|-0.170|
91565643|NCT00666835|183020044|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Difference LSM of Epo Hexal & Erypo|0.189|||||TWO_SIDED|95.0|-0.039|0.418||||||||0.418|-0.039|
91565644|NCT02959177|183020103|SUPERIORITY||LSMean Difference|-3.01|||<|0.001|TWO_SIDED|95.0|-3.8|-2.22|||Mixed Models Analysis|||||-2.22|-3.80|<0.001
91565645|NCT02959177|183020103|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.53|-1.94|||Mixed Models Analysis|||||-1.94|-3.53|<0.001
91565646|NCT02959177|183020104|SUPERIORITY||Odds Ratio (OR)|3.89|||||TWO_SIDED|95.0|2.71|5.57||||||||5.57|2.71|
91565647|NCT02959177|183020104|SUPERIORITY||Odds Ratio (OR)|3.664|||||TWO_SIDED|95.0|2.54|5.23||||||||5.23|2.54|
91565648|NCT02959177|183020105|SUPERIORITY||Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|2.14|4.89||||||||4.89|2.14|
91565649|NCT02959177|183020105|SUPERIORITY||Odds Ratio (OR)|3.16|||||TWO_SIDED|95.0|2.08|4.8||||||||4.80|2.08|
91565650|NCT02959177|183020106|SUPERIORITY||Odds Ratio (OR)|3.47|||||TWO_SIDED|95.0|2.03|5.93||||||||5.93|2.03|
91565651|NCT02959177|183020106|SUPERIORITY||Odds Ratio (OR)|3.13|||||TWO_SIDED|95.0|1.79|5.44||||||||5.44|1.79|
91565652|NCT02959177|183020107|SUPERIORITY||LSMean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.54|9.46|||Mixed Models Analysis|||||9.46|4.54|<0.001
91565653|NCT02959177|183020107|SUPERIORITY||Mean Difference (Final Values)|5.79|||<|0.01|TWO_SIDED|95.0|3.33|8.24|||Mixed Models Analysis|||||8.24|3.33|<0.01
91565654|NCT02959177|183020108|SUPERIORITY||LSMean difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.61|-2.19|||Mixed Models Analysis|||||-2.19|-3.61|<0.001
91565655|NCT02959177|183020108|SUPERIORITY||LSMean difference|-2.7|||<|0.001|TWO_SIDED|95.0|-3.41|-1.99|||Mixed Models Analysis|||||-1.99|-3.41|<0.001
91565656|NCT02959177|183020110|SUPERIORITY||LSMean Difference|-11.82|||<|0.001|TWO_SIDED|95.0|-16.14|-7.51|||Mixed Models Analysis|||||-7.51|-16.14|<0.001
91565657|NCT02959177|183020110|SUPERIORITY||LSMean difference|-13.73|||<|0.001|TWO_SIDED|95.0|-18.05|-9.4|||Mixed Models Analysis|||||-9.40|-18.05|<0.001
91565658|NCT02959177|183020111|SUPERIORITY||LSMean Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-8.06|-1.73|||Mixed Models Analysis|||||-1.73|-8.06|<0.001
91565659|NCT02959177|183020111|SUPERIORITY||LSMean Difference|-2.97|||<|0.001|TWO_SIDED|95.0|-6.08|0.14|||Mixed Models Analysis|||||0.14|-6.08|<.001
91565660|NCT03544229|183020118|SUPERIORITY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.25|=|0.618|TWO_SIDED|90.0|-0.34|0.49||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.49|-0.34|=0.618
91565661|NCT03544229|183020118|SUPERIORITY||Least Square Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17|=|0.533|TWO_SIDED|90.0|-0.27|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.27|=0.533
91565662|NCT03544229|183020118|SUPERIORITY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.167|=|0.447|TWO_SIDED|90.0|-0.3|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.30|=0.447
91565663|NCT03544229|183020119|SUPERIORITY||Odds Ratio (OR)|0.87|||=|0.607|TWO_SIDED|90.0|0.39|1.96|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.96|0.39|=0.607
91565664|NCT03544229|183020119|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.283|TWO_SIDED|90.0|0.7|2.1|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||2.10|0.70|=0.283
91565665|NCT03544229|183020119|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.527|TWO_SIDED|90.0|0.56|1.69|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.69|0.56|=0.527
91565666|NCT03544229|183020120|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.279|=|0.584|TWO_SIDED|90.0|-0.4|0.52||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.52|-0.40|=0.584
91565667|NCT03544229|183020120|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.625|TWO_SIDED|90.0|-0.25|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.25|=0.625
91565668|NCT03544229|183020120|SUPERIORITY||Least-Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.187|=|0.54|TWO_SIDED|90.0|-0.29|0.33||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.33|-0.29|=0.540
91565669|NCT03544229|183020121|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.283|=|0.51|TWO_SIDED|90.0|-0.46|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.46|=0.510
91565670|NCT03544229|183020121|SUPERIORITY||Least-Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.192|=|0.674|TWO_SIDED|90.0|-0.23|0.4||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.40|-0.23|=0.674
91565671|NCT03544229|183020121|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.367|TWO_SIDED|90.0|-0.38|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.38|=0.367
91565672|NCT03544229|183020122|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.289|=|0.587|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.587
91565673|NCT03544229|183020122|SUPERIORITY||Least-Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.196|=|0.6|TWO_SIDED|90.0|-0.27|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.27|=0.600
91565674|NCT03544229|183020122|SUPERIORITY||Least-Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193|=|0.446|TWO_SIDED|90.0|-0.34|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.34|=0.446
91565675|NCT03544229|183020123|SUPERIORITY||Least-Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.245|=|0.562|TWO_SIDED|90.0|-0.37|0.44||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.44|-0.37|=0.562
91565676|NCT03544229|183020123|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.166|=|0.138|TWO_SIDED|90.0|-0.46|0.09||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.46|=0.138
91565677|NCT03544229|183020123|SUPERIORITY||Least-Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164|=|0.394|TWO_SIDED|90.0|-0.32|0.23||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.23|-0.32|=0.394
91565678|NCT03544229|183020124|SUPERIORITY||Least-Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.484|=|0.709|TWO_SIDED|90.0|-0.53|1.07||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||1.07|-0.53|=0.709
91565679|NCT03544229|183020124|SUPERIORITY||Least-Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.332|=|0.76|TWO_SIDED|90.0|-0.31|0.78||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.78|-0.31|=0.760
91565680|NCT03544229|183020124|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.33|=|0.591|TWO_SIDED|90.0|-0.47|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.47|=0.591
91565681|NCT03544229|183020125|SUPERIORITY||Least-Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.27|=|0.742|TWO_SIDED|90.0|-0.27|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.27|=0.742
91565682|NCT03544229|183020125|SUPERIORITY||Least-Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.183|=|0.461|TWO_SIDED|90.0|-0.32|0.28||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.28|-0.32|=0.461
91565683|NCT03544229|183020125|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.181|=|0.376|TWO_SIDED|90.0|-0.36|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.36|=0.376
91565684|NCT03544229|183020126|SUPERIORITY||Least-Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.286|=|0.591|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.591
91565685|NCT03544229|183020126|SUPERIORITY||Least-Squares mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.193|=|0.291|TWO_SIDED|90.0|-0.43|0.21||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.21|-0.43|=0.291
91565686|NCT03544229|183020126|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191|=|0.476|TWO_SIDED|90.0|-0.33|0.3||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.30|-0.33|=0.476
91565687|NCT03544229|183020127|SUPERIORITY||Least-Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.224|=|0.675|TWO_SIDED|90.0|-0.27|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.27|=0.675
91565688|NCT03544229|183020127|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.152|=|0.531|TWO_SIDED|90.0|-0.24|0.26||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.26|-0.24|=0.531
91565689|NCT03544229|183020127|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|=|0.473|TWO_SIDED|90.0|-0.26|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.26|=0.473
91565690|NCT03544229|183020128|SUPERIORITY||Least-Squares Mean Difference|-8.47|STANDARD_ERROR_OF_MEAN|9.71|=|0.192|TWO_SIDED|90.0|-24.5|7.57||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 -Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.57|-24.50|=0.192
91565691|NCT03544229|183020128|SUPERIORITY||Least-Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|6.736|=|0.236|TWO_SIDED|90.0|-15.98|6.27||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||6.27|-15.98|=0.236
91565692|NCT03544229|183020128|SUPERIORITY||Least-Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|6.689|=|0.297|TWO_SIDED|90.0|-14.62|7.47||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.47|-14.62|=0.297
91565693|NCT03544229|183020129|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.3|=|0.601|TWO_SIDED|90.0|-0.42|0.57||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.57|-0.42|=0.601
91565694|NCT03544229|183020129|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2|=|0.181|TWO_SIDED|90.0|-0.51|0.15||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.15|-0.51|=0.181
91565695|NCT03544229|183020129|SUPERIORITY||Least-Squares Mean Diferrence|-0.24|STANDARD_ERROR_OF_MEAN|0.196|=|0.114|TWO_SIDED|90.0|-0.56|0.09||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.56|=0.114
91565696|NCT02460562|183020130|SUPERIORITY||||||<|0.05||||||Mean salivary fluoride concentrations (part per million) between groups were assessed at different time points using repeated measures analysis of variance. Saliva fluoride concentration from each groups were compared with baseline using a t-test.|ANOVA|||Mean saliva fluoride concentration (part per million) collected at different time points was compared in order to assess the change in capacity for fluoride release and recharge from the resin denture base and to assess differences between the control and the intervention group.||||<0.05
91565697|NCT02460562|183020131|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Caries assessments were performed to examine the difference in mean number of surface caries (DMFS) ± standard deviation between the control and the intervention groups at baseline and at 1.5 years.The transition (∆Q) of developed new caries surfaces (ICDAS score 1-3) from baseline to 1.5 years of follow-up for the two groups was analyzed with respect to arrest or progress rates. Numbers of new caries surfaces were compared by independent t-test, Pearson chi-square and correlation coefficient.||||<0.05
91565698|NCT01061775|183020132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.05
91565699|NCT01061775|183020133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91565700|NCT01061775|183020134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91565701|NCT01061775|183020135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91565702|NCT01954771|183020160|SUPERIORITY_OR_OTHER||Correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
91565703|NCT01954771|183020160|SUPERIORITY_OR_OTHER||Correlation coefficient|0.522||||0.004|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||0.004
91565704|NCT01954771|183020160|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.784|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
91565705|NCT01954771|183020160|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.533||||0.011|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.011
91565706|NCT01954771|183020160|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.479||||0.009|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.009
91565707|NCT01954771|183020160|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.801|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||<0.001
91565708|NCT02498418|183020179|EQUIVALENCE|Bioequivalence was demonstrated if 90% confidence interval (CI) of percentage difference between generic rifaximin 200 mg tablets and xifaxan 200 mg tablets was within the equivalence range (-20%, +20%).|Difference in percentage of participants|-0.0193|||||TWO_SIDED|90.0|-0.11|0.07||||||Bioequivalence was evaluated based on the PP analysis set using Z-test with Yates correction.||0.07|-0.11|
91565709|NCT02498418|183020182|SUPERIORITY||Difference in percentage of participants|-0.0195||||0.7899|TWO_SIDED|95.0|-0.09|0.13||Threshold of significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.13|-0.09|0.7899
91565710|NCT02498418|183020182|SUPERIORITY||Difference in percentage of participants|0.033||||0.5987|TWO_SIDED|95.0|-0.07|0.14||Threshold for significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.14|-0.07|0.5987
91565711|NCT00999141|183020241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||two-sided paired t-test|alpha = 5%||||||<0.0001
91565712|NCT00999141|183020244|SUPERIORITY_OR_OTHER||Difference in Proportions|0.04||||0.257||95.0|-0.039|0.125|||McNemar|alpha = 5%|Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||0.125|-0.039|0.257
91565713|NCT00999141|183020245|SUPERIORITY_OR_OTHER||Difference in proportions|-0.373|||<|0.001||95.0|-0.524|-0.193|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.193|-0.524|<0.001
91565714|NCT00999141|183020246|SUPERIORITY_OR_OTHER||Difference in proportions|-0.387|||<|0.001||95.0|-0.538|-0.205|||McNemar||Difference in Proportions = SoC - FS VH S/D 4 s-apr|||-0.205|-0.538|<0.001
91565715|NCT00999141|183020247|SUPERIORITY_OR_OTHER||Difference in proportions|-0.356||||0.001||95.0|-0.521|-0.161|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.161|-0.521|0.001
91565716|NCT00999141|183020248|SUPERIORITY_OR_OTHER||Difference in proportions|-0.189||||0.027||95.0|-0.342|-0.023|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.023|-0.342|0.027
91565717|NCT00999141|183020251|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.413||||||95.0|-0.577|-0.213|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.213|-0.577|
91565718|NCT00999141|183020252|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.227||||||95.0|-0.413|-0.02|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.020|-0.413|
91565719|NCT00999141|183020253|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.347||||||95.0|-0.518|-0.145|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.145|-0.518|
91565720|NCT00999141|183020254|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.365||||||95.0|-0.528|-0.171|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.171|-0.528|
91565721|NCT03638258|183020338|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||<0.001
91565722|NCT03638258|183020338|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpolation was not computationally possible.||||||0.004|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||0.004
91565723|NCT03638258|183020339|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.015
91565724|NCT03638258|183020339|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.174|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from placebo at Week 4||||0.174
91565725|NCT03638258|183020339|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
91565726|NCT03638258|183020339|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.001
91565727|NCT03638258|183020339|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||<0.001
91565728|NCT03638258|183020339|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.008
91565729|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
91565730|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
91565731|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
91565732|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
91565733|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.x|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
91565734|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
91565735|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
91565736|NCT03638258|183020340|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
91565737|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream on Week 4||||<0.001
91565738|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 4||||<0.001
91565739|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
91565740|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
91565741|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 8||||<0.001
91565742|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 8||||<0.001
91565743|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 12||||<0.001
91565744|NCT03638258|183020341|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 12||||<0.001
91565745|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.116|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.116
91565746|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.423|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.423
91565747|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.002
91565748|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.038|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.038
91565749|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
91565750|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.005|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.005
91565751|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.002
91565752|NCT03638258|183020342|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.013
91565753|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.086|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference form vehicle cream at Week 4||||0.086
91565754|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.123|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 4||||0.123
91565755|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.017|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.017
91565756|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.415|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.415
91565757|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.007|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.007
91565758|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.175|||||||Regression, Linear|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.175
91565759|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle at Week 12||||0.001
91565760|NCT03638258|183020343|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.619|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 12||||0.619
91565761|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||<0.001
91565762|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
91565763|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
91565764|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
91565765|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
91565766|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
91565767|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
91565768|NCT03638258|183020344|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
91565769|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
91565770|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.203|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.203
91565771|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.034|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.034
91565772|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.012|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.012
91565773|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.010
91565774|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.075|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.075
91565775|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
91565776|NCT03638258|183020345|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
91565777|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.527|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.527
91565778|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.444|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.444
91565779|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.006|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.006
91565780|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.013
91565781|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.002
91565782|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.064|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.064
91565783|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.002
91565784|NCT03638258|183020346|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
91565785|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.188|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.188
91565786|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.577|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.577
91565787|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.008
91565788|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.664|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.664
91565789|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.015
91565790|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.666|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.666
91565791|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
91565792|NCT03638258|183020347|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.163|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.163
91565793|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||||||0.002|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream on Week 4||||0.002
91565794|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 4||||0.002
91565795|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 6||||<0.001
91565796|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 6||||<0.001
91565797|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 8||||<0.001
91565798|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 8||||<0.001
91565799|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
91565800|NCT03638258|183020348|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
91565801|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.184|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score.||Difference from vehicle cream at Week 4||||0.184
91565802|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.207|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from placebo at Week 4||||0.207
91565803|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.004|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.004
91565804|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.022|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.022
91565805|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||0.003
91565806|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||<0.001
91565807|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 12||||0.003
91565808|NCT03638258|183020349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01||||||ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.|ANCOVA|||Difference from vehicle cream at Week 12||||0.01
91565809|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.255|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 4||||0.255
91565810|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.687|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream on Week 4||||0.687
91565811|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.045|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.045
91565812|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.059|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.059
91565813|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.051|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.051
91565814|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.013
91565815|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.036|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.036
91565816|NCT03638258|183020350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.001
91565817|NCT04405089|183020370|OTHER||Linear regression|0.03|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus Binge Eating Scale score at baseline).||||
91565818|NCT04405089|183020371|OTHER||Linear regression|-0.33|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Flanker score at baseline).||||
91565819|NCT04405089|183020372|OTHER||Linear regression|0.04|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Set Shifting score at baseline).||||
91565820|NCT00179478|183020373|SUPERIORITY|||||||0.001||||||Based on adjusted Hazard Ratio (HR)|Regression, Cox|HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions||||||0.001
91565821|NCT00179478|183020374|SUPERIORITY|||||||0.02||||||a priori threshold for statistical significance was a p value less than 0.01|Wilcoxon (Mann-Whitney)|||||||0.02
91565822|NCT00179478|183020375|SUPERIORITY|||||||0.61||||||a priori threshold for statistical significance was a p value \< 0.01|Fisher Exact|||||||0.61
91565823|NCT00179478|183020376|SUPERIORITY|||||||0.5||||||a priori threshold for statistical significant was a p value less than 0.01|Fisher Exact|||||||0.50
91565824|NCT00603278|183020413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|||<|0.001|TWO_SIDED|95.0|0.096|0.318|||ANCOVA|||||0.318|0.096|<0.001
91565825|NCT00603278|183020413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.127|0.349|||ANCOVA|||||0.349|0.127|<0.001
91565826|NCT00603278|183020413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.182|0.404|||ANCOVA|||||0.404|0.182|<0.001
91565827|NCT00603278|183020413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279|||<|0.001|TWO_SIDED|95.0|0.167|0.392|||ANCOVA|||||0.392|0.167|<0.001
91565828|NCT00603278|183020413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.114|0.337|||ANCOVA|||||0.337|0.114|<0.001
91565829|NCT04853394|183020439|SUPERIORITY||Risk Ratio (RR)|0.33|||<|0.01|TWO_SIDED|95.0|0.21|0.51|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.51|.21|<.01
91565830|NCT04853394|183020440|SUPERIORITY||Risk Ratio (RR)|0.67||||0.01|TWO_SIDED|95.0|0.46|0.97|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.97|.46|.01
91565831|NCT04853394|183020441|SUPERIORITY||Risk Ratio (RR)|0.86||||0.01|TWO_SIDED|95.0|0.77|0.95|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 6-month follow-up|||.95|.77|.01
91565832|NCT04853394|183020441|SUPERIORITY||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|0.98|1.45|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||1.45|.98|.01
91565833|NCT04853394|183020444|SUPERIORITY||Risk Ratio (RR)|0.12||||0.01|TWO_SIDED|95.0|0.07|0.19|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.19|.07|.01
91565834|NCT01772147|183020466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.089|0.164|||Mixed Models Analysis|||||0.164|0.089|<0.001
91565835|NCT01772147|183020466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|||<|0.001|TWO_SIDED|95.0|0.111|0.185|||Mixed Models Analysis|||||0.185|0.111|<0.001
91565836|NCT00796614|183020470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5388|TWO_SIDED|95.0|0.5|3.8|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.80|0.50|0.5388
91565837|NCT00796614|183020470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.343|TWO_SIDED|95.0|0.2|1.76|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||1.76|0.20|0.3430
91565838|NCT00796614|183020470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.5209|TWO_SIDED|95.0|0.5|3.97|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.97|0.50|0.5209
91565839|NCT00796614|183020470|SUPERIORITY_OR_OTHER|||||||0.9436|||||||Cochran-Armitage trend test|||A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran-Armitage trend test.||||0.9436
91565840|NCT00796614|183020471|SUPERIORITY_OR_OTHER|||||||0.3097|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.3097
91565841|NCT00796614|183020471|SUPERIORITY_OR_OTHER|||||||0.2676|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.2676
91565842|NCT00796614|183020471|SUPERIORITY_OR_OTHER|||||||0.6265|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6265
91565843|NCT00796614|183020472|SUPERIORITY_OR_OTHER|||||||0.4359|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.4359
91565844|NCT00796614|183020472|SUPERIORITY_OR_OTHER|||||||0.0658|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.0658
91565845|NCT00796614|183020472|SUPERIORITY_OR_OTHER|||||||0.6709|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6709
91565846|NCT00796614|183020473|SUPERIORITY_OR_OTHER|||||||0.5672|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5672
91565847|NCT00796614|183020473|SUPERIORITY_OR_OTHER|||||||0.8724|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8724
91565848|NCT00796614|183020473|SUPERIORITY_OR_OTHER|||||||0.7674|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7674
91565849|NCT00796614|183020473|SUPERIORITY_OR_OTHER|||||||0.5545|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5545
91565850|NCT00796614|183020473|SUPERIORITY_OR_OTHER|||||||0.4774|||||||Regression, Logistic|||Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.4774
91565851|NCT00796614|183020473|SUPERIORITY_OR_OTHER|||||||0.8626|||||||Regression, Logistic|||Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8626
91565852|NCT00796614|183020474|SUPERIORITY_OR_OTHER|||||||0.9669|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9669
91565853|NCT00796614|183020474|SUPERIORITY_OR_OTHER|||||||0.9231|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9231
91565854|NCT00796614|183020474|SUPERIORITY_OR_OTHER|||||||0.636|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.6360
91565855|NCT00796614|183020474|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||1.0000
91565856|NCT00796614|183020474|SUPERIORITY_OR_OTHER|||||||0.4925|||||||Fisher Exact|||Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4925
91565857|NCT00796614|183020474|SUPERIORITY_OR_OTHER|||||||0.4977|||||||Fisher Exact|||Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4977
91565858|NCT00796614|183020475|SUPERIORITY_OR_OTHER|||||||0.1373|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.1373
91565859|NCT00796614|183020475|SUPERIORITY_OR_OTHER|||||||0.744|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7440
91565860|NCT00796614|183020475|SUPERIORITY_OR_OTHER|||||||0.7703|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7703
91565861|NCT00796614|183020476|SUPERIORITY_OR_OTHER|||||||0.0808|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.0808
91565862|NCT00796614|183020476|SUPERIORITY_OR_OTHER|||||||0.8244|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8244
91565863|NCT00796614|183020476|SUPERIORITY_OR_OTHER|||||||0.5045|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5045
91565864|NCT00993798|183020480|SUPERIORITY||LS Mean Difference|-1.27|STANDARD_DEVIATION|0.5||0.012|TWO_SIDED|95.0|-2.25|-0.28|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||-0.28|-2.25|0.012
91565865|NCT00993798|183020481|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.01|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.0|-12.0|0.010
91565866|NCT00993798|183020482|SUPERIORITY|||||||0.014|||||||Log Rank|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||||0.014
91565867|NCT00993798|183020483|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||0.773|TWO_SIDED|95.0|-0.18|0.14|||ANOVA|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.14|-0.18|0.773
91565868|NCT02983877|183020484|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
91565869|NCT02983877|183020485|SUPERIORITY||||||<|0.001|||||||ANOVA|3 degrees of freedom||||||<0.001
91565870|NCT02983877|183020486|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
91565871|NCT02983877|183020487|SUPERIORITY|||||||0.89|||||||ANOVA|2 degrees of freedom||||||0.89
91565872|NCT02762500|183020496|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
91565873|NCT02762500|183020497|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
91565874|NCT02762500|183020498|SUPERIORITY||Risk Difference (RD)|-6.5||||0.235|TWO_SIDED|90.0|-21.1|8.2||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||8.2|-21.1|0.235
91565875|NCT02762500|183020499|SUPERIORITY||Risk Difference (RD)|-9.7||||0.14|TWO_SIDED|90.0|-24.3|5.0||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||5.0|-24.3|0.140
91565876|NCT02762500|183020500|SUPERIORITY||Mean Difference (Final Values)|-44.59||||0.032|TWO_SIDED|90.0|-78.66|-10.53|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.||-10.53|-78.66|0.032
91565877|NCT02762500|183020501|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.708|TWO_SIDED|90.0|-0.6|0.95|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||||0.95|-0.60|0.708
91565878|NCT00632931|183020537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||||90.0|-0.28|6.28||||||||6.28|-0.28|
91565879|NCT00632931|183020538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||||90.0|-1.38|4.72||||||||4.72|-1.38|
91565880|NCT00632931|183020539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07||||||90.0|-0.17|6.31||||||||6.31|-0.17|
91565881|NCT00632931|183020540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||||90.0|-0.4|6.08||||||||6.08|-0.40|
91565882|NCT00632931|183020541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44||||||90.0|3.21|9.68||||||||9.68|3.21|
91565883|NCT00632931|183020542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||||90.0|1.05|7.6||||||||7.60|1.05|
91565884|NCT00632931|183020543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||||90.0|-0.7|6.02||||||||6.02|-0.70|
91565885|NCT00632931|183020544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51||||||90.0|3.19|9.82||||||||9.82|3.19|
91565886|NCT01057888|183020545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||<|0.05|TWO_SIDED|95.0|1.0|1.7|||Regression, Cox|It is a robust, clustered stratified Cox regression model|The control group serves as the denominator. The telephone reminder group serves as the numerator.|The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.||1.7|1.0|<0.05
91565887|NCT01057888|183020545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||<|0.01|TWO_SIDED|95.0|1.3|2.1|||Regression, Cox|We used a robust, clustered, stratified Cox regression model.|The control group represents the denominator. The letter reminder group represents the numerator.|||2.1|1.3|<0.01
91565888|NCT01057888|183020545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.075|TWO_SIDED|95.0|1.0|1.6|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator.|The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder arms||1.6|1.0|0.075
91565889|NCT01057888|183020546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||<|0.01|TWO_SIDED|95.0|1.1|1.3|||Regression, Cox||The control group represents the denominator and the mailed reminder group represents the numerator.|The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control group||1.3|1.1|<0.01
91565890|NCT01057888|183020546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||<|0.05|TWO_SIDED|95.0|1.0|1.3|||Regression, Cox||The control group represents the denominator and the telephone reminder group represents the numerator|The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control group||1.3|1.0|<0.05
91565891|NCT01057888|183020546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.234|TWO_SIDED|95.0|1.0|1.2|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator|The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the intervention||1.2|1.0|0.234
91565892|NCT03319719|183020560|SUPERIORITY||Mean Difference (Net)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.42|-2.33||p-value from paired two-sided t-tests of no difference between test and control groups.|t-test, 2 sided|||||-2.33|-3.42|<0.0001
91565893|NCT00991029|183020574|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.02|TWO_SIDED|95.0|0.59|0.95|||Log Rank|||||0.95|0.59|0.02
91565894|NCT00991029|183020575|SUPERIORITY||Hazard Ratio (HR)|2.32||||0.02|TWO_SIDED|95.0|1.1|4.87|||Log Rank|||||4.87|1.10|0.02
91565895|NCT00991029|183020576|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.01
91565896|NCT00991029|183020577|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.46|TWO_SIDED|95.0|0.55|3.78|||Log Rank|||||3.78|0.55|0.46
91565897|NCT00991029|183020578|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.52|TWO_SIDED|95.0|0.43|5.35|||Log Rank|||||5.35|0.43|0.52
91565898|NCT00991029|183020579|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.01|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.01
91565899|NCT00991029|183020580|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.13|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.13
91565900|NCT00991029|183020581|SUPERIORITY||Hazard Ratio (HR)|1.68||||0.47|TWO_SIDED|95.0|0.4|7.03|||Log Rank|||||7.03|0.4|0.47
91565901|NCT00991029|183020582|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.14|7.14|||Log Rank|||||7.14|0.14|0.99
91565902|NCT00991029|183020583|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
91565903|NCT00991029|183020584|SUPERIORITY||Hazard Ratio (HR)|2.45||||0.04|TWO_SIDED|95.0|1.01|5.9|||Log Rank|||||5.9|1.01|0.04
91565904|NCT00991029|183020585|SUPERIORITY||Hazard Ratio (HR)|3.12|||<|0.001|TWO_SIDED|95.0|1.67|5.83|||Log Rank|||||5.83|1.67|<0.001
91565905|NCT00991029|183020586|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.27|TWO_SIDED|95.0|0.73|3.13|||Log Rank|||||3.13|0.73|0.27
91565906|NCT02853305|183020610|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0033|TWO_SIDED|95.0|0.65|0.93|||Stratified Log-Rank|The treatment difference in PFS was assessed by the stratified log-rank test.||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the chemo arm to address the first primary hypothesis (superiority to chemo). The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||0.93|0.65|0.0033
91565907|NCT02853305|183020611|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0407|TWO_SIDED|95.0|0.72|1.02|||Stratified Log-Rank|The treatment difference in OS was assessed by the stratified log-rank test.||OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.02|0.72|0.0407
91565908|NCT02853305|183020612|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.77|1.32||No formal hypothesis testing was performed.||||OS in CPS≥10 participants of the pembro arm was compared to OS in CPS≥10 participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) at baseline.||1.32|0.77|
91565909|NCT02853305|183020613|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.11||No formal hypothesis testing was performed.||||OS in all participants of the pembro arm was compared to OS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.11|0.77|
91565910|NCT02853305|183020614|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|1.09|1.58||No formal hypothesis testing was performed.||||PFS in all participants of the pembro arm was compared to PFS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.58|1.09|
91565911|NCT02853305|183020617|OTHER||Difference in Percentage|9.8|||||TWO_SIDED|95.0|2.4|17.1||No formal hypothesis testing was performed.||||ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||17.1|2.4|
91565912|NCT02853305|183020619|OTHER||Difference in Percentage|4.5|||||TWO_SIDED|95.0|-1.6|10.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro combo arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||10.6|-1.6|
91565913|NCT02853305|183020620|SUPERIORITY||Difference in Percentage|-14.8|||||TWO_SIDED|95.0|-22.0|-7.4||No formal hypothesis testing was performed.||||ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-7.4|-22.0|
91565914|NCT02853305|183020622|OTHER||Difference in Percentage|-28.9|||||TWO_SIDED|95.0|-35.9|-21.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-21.6|-35.9|
91565915|NCT02853305|183020626|OTHER||Difference in LS Means|2.68|||||TWO_SIDED|95.0|-0.76|6.12||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||6.12|-0.76|
91565916|NCT02853305|183020627|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|1.0||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.00|0.62|
91565917|NCT02853305|183020628|OTHER||Difference in LS Means|-0.94|||||TWO_SIDED|95.0|-5.06|3.18||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on cLDA model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||3.18|-5.06|
91565918|NCT02853305|183020629|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.93|1.49||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.49|0.93|
91565919|NCT01947153|183020638|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
91565920|NCT01947153|183020639|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.14|STANDARD_ERROR_OF_MEAN|1.032|<|0.0001|TWO_SIDED|90.0|99.645|110.941||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.941|99.645|<0.0001
91565921|NCT01947153|183020640|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|109.05|STANDARD_ERROR_OF_MEAN|1.063||0.0014|TWO_SIDED|90.0|98.299|120.968||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||120.968|98.299|0.0014
91565922|NCT01947153|183020641|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.81|STANDARD_ERROR_OF_MEAN|1.043|<|0.0001|TWO_SIDED|90.0|98.471|113.692||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||113.692|98.471|<0.0001
91565923|NCT01947153|183020642|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.48|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.177|105.208||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||105.208|92.177|<0.0001
91565924|NCT01947153|183020643|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|104.62|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.274|110.254||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.254|99.274|<0.0001
91565925|NCT01947153|183020644|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
91565926|NCT02381652|183020645|OTHER|Statistical test to see if there is a difference||||||0.3108|||||||Fisher Exact|||||||0.3108
91565927|NCT01163955|183020671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.92|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in the floor.||9|0|<.0005
91565928|NCT01163955|183020671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|1.99|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in a chair.||9|0|<.0005
91565929|NCT00784277|183020672|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|55.1|STANDARD_ERROR_OF_MEAN|20.37||0.007||95.0|15.11|95.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||95.13|15.11|0.007
91565930|NCT00784277|183020672|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|63.4|STANDARD_ERROR_OF_MEAN|20.23||0.004||95.0|23.67|103.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||103.13|23.67|0.004
91565931|NCT00784277|183020673|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|2.22|4.01||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||4.01|2.22|<0.001
91565932|NCT00784277|183020673|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|2.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|1.34|3.12||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||3.12|1.34|<0.001
91565933|NCT00784277|183020673|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|1.6|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|0.72|2.5||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||2.50|0.72|<0.001
91565934|NCT02567227|183020688|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.54|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.||1.54|-3.60|
91565935|NCT02567227|183020688|SUPERIORITY||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.59|3.76||P-values from linear mixed effects models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status|||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.||3.76|-2.59|
91565936|NCT02567227|183020689|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.49|0.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.||0.20|-0.49|
91565937|NCT02567227|183020690|SUPERIORITY||Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.13|3.79|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.||3.79|-2.13|
91565938|NCT02567227|183020690|SUPERIORITY||Mean Difference (Net)|-1.95|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED||||||||Estimates with standard errors are from linear mixed effect models.|Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.||||
91565939|NCT02567227|183020691|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.91|0.43|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.||0.43|-0.91|
91565940|NCT02567227|183020691|SUPERIORITY||Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.16|0.27|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.||0.27|-1.16|
91565941|NCT02567227|183020692|SUPERIORITY||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.51|0.19|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.||0.19|-0.51|
91565942|NCT02567227|183020692|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.2|0.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.||0.41|-0.20|
91565943|NCT02567227|183020692|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.53|0.32|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.||0.32|-0.53|
91565944|NCT02567227|183020692|SUPERIORITY||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.27|0.56|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.||0.56|-0.27|
91565945|NCT02567227|183020692|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.48|0.45|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.||0.45|-0.48|
91565946|NCT02567227|183020692|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.4|0.35|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.||0.35|-0.40|
91565947|NCT02567227|183020693|SUPERIORITY||Odds Ratio (OR)|0.925|||||TWO_SIDED|95.0|0.369|2.319||||||Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||2.319|0.369|
91565948|NCT02567227|183020693|SUPERIORITY||Odds Ratio (OR)|0.961|||||TWO_SIDED|95.0|0.516|1.789||||||Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||1.789|0.516|
91565949|NCT02567227|183020694|SUPERIORITY||Mean Difference (Net)|-7.52|STANDARD_ERROR_OF_MEAN|14.17|||TWO_SIDED|95.0|-35.45|20.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.||20.41|-35.45|
91565950|NCT02567227|183020695|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-0.3|2.31|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.||2.31|-0.30|
91565951|NCT02567227|183020696|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.||||
91565952|NCT02567227|183020697|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.07|0.06|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.||0.06|-0.07|
91565953|NCT02567227|183020698|SUPERIORITY||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.86|2.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.||2.20|-0.86|
91565954|NCT02567227|183020701|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-1.65|3.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.||3.91|-1.65|
91565955|NCT02567227|183020701|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-2.12|4.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.||4.91|-2.12|
91565956|NCT02567227|183020702|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.||||
91565957|NCT02567227|183020703|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.||||
91565958|NCT02567227|183020704|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.4|0.93|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.||0.93|-0.40|
91565959|NCT02567227|183020706|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.38|2.16|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.||2.16|-1.38|
91565960|NCT02567227|183020707|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.46|1.04|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.||1.04|-1.46|
91565961|NCT02567227|183020707|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.04|1.85|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.||1.85|-1.04|
91565962|NCT00187135|183020713|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
91565963|NCT00187135|183020713|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.||||0.5
91565964|NCT00187135|183020714|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
91565965|NCT00187135|183020715|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.||||0.87
91565966|NCT00187135|183020716|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.||||0.67
91565967|NCT00187135|183020717|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.||||0.52
91565968|NCT00187135|183020718|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.||||0.99
91565969|NCT03866434|183020749|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LSmeans|64.225|||||TWO_SIDED|90.0|53.212|77.516|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the least squares (LS) mean difference in the log-transformed parameters back transformed to the original scale) and their 90 percent (%) confidence intervals (CI) were calculated.||77.516|53.212|
91565970|NCT03866434|183020750|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|%ratio of Geometric LeastSquare(LS)means|82.203|||||TWO_SIDED|90.0|71.501|94.507|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||94.507|71.501|
91565971|NCT03866434|183020751|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.705|||||TWO_SIDED|90.0|64.555|84.152|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||84.152|64.555|
91565972|NCT03866434|183020752|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|85.527|||||TWO_SIDED|90.0|78.163|93.584|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||93.584|78.163|
91565973|NCT03866434|183020753|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.007|||||TWO_SIDED|90.0|62.528|85.243|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||85.243|62.528|
91565974|NCT03866434|183020754|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|86.504|||||TWO_SIDED|90.0|78.462|95.371|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||95.371|78.462|
91565975|NCT03280108|183020769|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.|Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0103|||ONE_SIDED|95.0||0.041||||||||0.041||
91565976|NCT03280108|183020770|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91565977|NCT03280108|183020776|SUPERIORITY||Least Squares Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.0153|<|0.001|TWO_SIDED|95.0|-0.287|-0.227|||Mixed Models Analysis|||||-0.227|-0.287|<0.001
91565978|NCT03280108|183020777|SUPERIORITY||Mantel-Haenszel common difference|71.2|||||TWO_SIDED|95.0|61.87|80.46||||||||80.46|61.87|
91565979|NCT00139659|183020813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.08|0.011|||longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||0.011|-0.080|
91565980|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.065|0.015|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.015|-0.065|
91565981|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.073|0.006|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.006|-0.073|
91565982|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.016|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.016|-0.063|
91565983|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.004|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.075|
91565984|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.067|0.012|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.012|-0.067|
91565985|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.073|0.008|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.008|-0.073|
91565986|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.059|0.023|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.059|
91565987|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.052|0.031|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.031|-0.052|
91565988|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.068|0.017|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.068|
91565989|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.117|-0.029|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.029|-0.117|
91565990|NCT00139659|183020814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.108|-0.015|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.015|-0.108|
91565991|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.214||||90.0|-0.679|0.026|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.679|
91565992|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.729|-0.027|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.027|-0.729|
91565993|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.696|0.004|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.696|
91565994|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.847|-0.145|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.145|-0.847|
91565995|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.96|-0.26|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.260|-0.960|
91565996|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-0.721|0.001|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.001|-0.721|
91565997|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.221||||90.0|-0.655|0.073|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.073|-0.655|
91565998|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.224||||90.0|-0.788|-0.052|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.052|-0.788|
91565999|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.337|STANDARD_ERROR_OF_MEAN|0.231||||90.0|-0.717|0.042|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.042|-0.717|
91566000|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.181|-0.397|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.397|-1.181|
91566001|NCT00139659|183020815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.178|-0.393|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.393|-1.178|
91566002|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.066|0.023|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.066|
91566003|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.044|0.044|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.044|-0.044|
91566004|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.056|0.032|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.032|-0.056|
91566005|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.048|0.041|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.048|
91566006|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.089|-0.001|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.001|-0.089|
91566007|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.035|0.056|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.056|-0.035|
91566008|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.028|0.064|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.064|-0.028|
91566009|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.051|0.041|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.051|
91566010|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.029||||90.0|-0.07|0.026|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.070|
91566011|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.064|0.034|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.034|-0.064|
91566012|NCT00139659|183020818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.031||||90.0|-0.067|0.037|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.037|-0.067|
91566013|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.632|STANDARD_ERROR_OF_MEAN|0.697||||90.0|-1.778|0.514|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.514|-1.778|
91566014|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-1.079|1.12|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.120|-1.079|
91566015|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.679||||90.0|-0.535|1.7|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.700|-0.535|
91566016|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.687||||90.0|-1.184|1.077|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.077|-1.184|
91566017|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.535|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.677|0.608|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.608|-1.677|
91566018|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.905|STANDARD_ERROR_OF_MEAN|0.674||||90.0|-2.014|0.203|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.203|-2.014|
91566019|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.675||||90.0|-0.899|1.323|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.323|-0.899|
91566020|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.683||||90.0|-1.08|1.169|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.169|-1.080|
91566021|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.382|0.902|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.902|-1.382|
91566022|NCT00139659|183020819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.711||||90.0|-1.673|0.668|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.668|-1.673|
91566023|NCT00139659|183020833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.216||||90.0|-0.858|-0.148|||Longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||-0.148|-0.858|
91566024|NCT00139659|183020837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.1||||90.0|-0.06|0.28|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.28|-0.06|
91566025|NCT00139659|183020837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1||||90.0|0.04|0.38|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.38|0.04|
91566026|NCT00139659|183020837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.01|0.34|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.34|-0.01|
91566027|NCT00139659|183020837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.03|0.32|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.32|-0.03|
91566028|NCT00139659|183020837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.12|0.24|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.24|-0.12|
91566029|NCT00139659|183020837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.19|0.22|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.22|-0.19|
91566030|NCT00139659|183020838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.615|STANDARD_ERROR_OF_MEAN|7.874||||90.0|-2.351|23.581|||Mixed Models Analysis|Confidence interval for the LS mean of that particular treatment.||Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||23.581|-2.351|
91566031|NCT00139659|183020838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.942|STANDARD_ERROR_OF_MEAN|7.804||||90.0|-19.79|5.909|||Mixed Models Analysis|||Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||5.909|-19.79|
91566032|NCT00139659|183020838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.622|STANDARD_ERROR_OF_MEAN|7.897||||90.0|-17.63|8.382|||Mixed Models Analysis|||Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||8.382|-17.63|
91566033|NCT00139659|183020838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.828|STANDARD_ERROR_OF_MEAN|7.888||||90.0|-11.16|14.817|||Mixed Models Analysis|||Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.817|-11.16|
91566034|NCT00139659|183020838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.149|STANDARD_ERROR_OF_MEAN|7.991||||90.0|-12.01|14.307|||Mixed Models Analysis|||Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.307|-12.01|
91566035|NCT00139659|183020838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.247|STANDARD_ERROR_OF_MEAN|7.816||||90.0|-8.664|17.157|||Mixed Models Analysis|||Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||17.157|-8.664|
91566036|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.455||||90.0|-1.829|-0.331|||Mixed Models Analysis|||Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.331|-1.829|
91566037|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.475|STANDARD_ERROR_OF_MEAN|0.461||||90.0|-1.233|0.284|||Mixed Models Analysis|||Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.284|-1.233|
91566038|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.185|STANDARD_ERROR_OF_MEAN|0.454||||90.0|-0.931|0.562|||Mixed Models Analysis|||Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.562|-0.931|
91566039|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189|STANDARD_ERROR_OF_MEAN|0.449||||90.0|-0.929|0.55|||Mixed Models Analysis|||Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.550|-0.929|
91566040|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.447||||90.0|-1.294|0.178|||Mixed Models Analysis|||Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.178|-1.294|
91566041|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.748|STANDARD_ERROR_OF_MEAN|0.467||||90.0|-1.517|0.022|||Mixed Models Analysis|||Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.022|-1.517|
91566042|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|STANDARD_ERROR_OF_MEAN|0.886||||90.0|-2.51|0.405|||Mixed Models Analysis|||Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.405|-2.510|
91566043|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.891|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.634|-0.149|||Mixed Models Analysis|||Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.149|-1.634|
91566044|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.453||||90.0|-1.725|-0.234|||Mixed Models Analysis|||Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.234|-1.725|
91566045|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.663|STANDARD_ERROR_OF_MEAN|0.448||||90.0|-1.4|0.075|||Mixed Models Analysis|||Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.075|-1.400|
91566046|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.537|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.279|0.205|||Mixed Models Analysis|||Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.205|-1.279|
91566047|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322|STANDARD_ERROR_OF_MEAN|1.027||||90.0|-3.012|0.369|||Mixed Models Analysis|||Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.369|-3.012|
91566048|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.552||||90.0|-0.847|0.972|||Mixed Models Analysis|||Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.972|-0.847|
91566049|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|STANDARD_ERROR_OF_MEAN|0.469||||90.0|-0.964|0.579|||Mixed Models Analysis|||Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.579|-0.964|
91566050|NCT00139659|183020839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.526||||90.0|-1.298|0.438|||Mixed Models Analysis|||Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.438|-1.298|
91566051|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.079|0.0|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.000|-0.079|
91566052|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.068|0.01|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.010|-0.068|
91566053|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.084|-0.006|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.006|-0.084|
91566054|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
91566055|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
91566056|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.017|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.063|
91566057|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.062|0.02|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.020|-0.062|
91566058|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.055|0.027|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.027|-0.055|
91566059|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.085|0.0|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.000|-0.085|
91566060|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.109|-0.022|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.022|-0.109|
91566061|NCT00139659|183020847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.097|-0.003|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.003|-0.097|
91566062|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.199||||90.0|-0.606|0.048|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.048|-0.606|
91566063|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.661|-0.011|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.011|-0.661|
91566064|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.384|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.707|-0.061|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.061|-0.707|
91566065|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.842|-0.191|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.191|-0.842|
91566066|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.474|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.797|-0.152|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.152|-0.797|
91566067|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.866|-0.2|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.200|-0.866|
91566068|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.509|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.845|-0.174|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.174|-0.845|
91566069|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.749|-0.076|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.076|-0.749|
91566070|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.707|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.056|-0.358|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.358|-1.056|
91566071|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-1.04|-0.32|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.320|-1.040|
91566072|NCT00139659|183020848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.116|-0.415|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.415|-1.116|
91566073|NCT01209936|183020890|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
91566074|NCT01209936|183020891|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91566075|NCT01209936|183020892|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91566076|NCT02391116|183020900|OTHER||Percentage Difference|2.2|||||TWO_SIDED|90.0|-28.7|32.9|||Exact confidence intervals (CI)||ORR difference in FAS (N=54): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||32.9|-28.7|
91566077|NCT02391116|183020900|OTHER||Percentage Difference|0.0|||||TWO_SIDED|90.0|-33.5|33.5|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||33.5|-33.5|
91566078|NCT02391116|183020901|OTHER||Percentage Difference|16.4|||||TWO_SIDED|90.0|-7.2|39.1|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||39.1|-7.2|
91566079|NCT02391116|183020901|OTHER||Percentage Difference|20.8|||||TWO_SIDED|90.0|-6.8|46.2|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||46.2|-6.8|
91566080|NCT02391116|183020901|OTHER||Percentage Difference|-18.5|||||TWO_SIDED|90.0|-40.1|4.6|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||4.6|-40.1|
91566081|NCT02391116|183020901|OTHER||Percentage Difference|-25.3|||||TWO_SIDED|90.0|-49.1|1.1|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||1.1|-49.1|
91566082|NCT02391116|183020901|OTHER||Percentage Difference|12.9|||||TWO_SIDED|90.0|-42.4|63.2|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||63.2|-42.4|
91566083|NCT02391116|183020901|OTHER||Percentage Difference|26.3|||||TWO_SIDED|90.0|-44.3|77.6|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||77.6|-44.3|
91566084|NCT01747629|183020921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|0.59|1.24||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.24|0.59|<0.0001
91566085|NCT01747629|183020922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.56|1.55||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.55|0.56|<0.0001
91566086|NCT01747629|183020923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.212||0.0004|TWO_SIDED|95.0|0.35|1.19||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.19|0.35|0.0004
91566087|NCT01747629|183020924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|0.57|1.28||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.28|0.57|<0.0001
91566088|NCT00607789|183020935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_DEVIATION|1.7|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods||||<0.05
91566089|NCT04089332|183020993|OTHER||Slope|-0.4465||||0.162|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs HOMA-IR|Adjusted R-squared = 0.117|||0.162
91566090|NCT04089332|183020993|OTHER||Slope|0.6704||||0.082|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs HOMA-IR|Adjusted R-squared = 0.221|||0.082
91566091|NCT04089332|183020993|OTHER||Slope|-0.8486||||0.286|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs HOMA-IR|Adjusted R-squared = 0.0503|||0.286
91566092|NCT04089332|183020993|OTHER||Slope|-0.0266||||0.635|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs HOMA-IR|Adjusted R-squared = 0|||0.635
91566093|NCT04089332|183020993|OTHER||Slope|-0.1588||||0.061|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs HOMA-IR|Adjusted R-squared = 0.381|||0.061
91566094|NCT04089332|183020993|OTHER||Slope|0.099||||0.479|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. HOMA-IR|Adjusted R-squared = 0|||0.479
91566095|NCT04089332|183020993|OTHER||Slope|0.0676||||0.965|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. HOMA-IR|Adjusted R-squared = 0|||0.965
91566096|NCT04089332|183020993|OTHER||Slope|-0.0091||||0.039|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. HOMA-IR|Adjusted R-squared = 0.324|||0.039
91566097|NCT04089332|183020993|OTHER||Slope|-4.2085||||0.018|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. HOMA-IR|Adjusted R-squared = 0.0423|||0.018
91566098|NCT04089332|183020994|OTHER||Slope|-1.1138||||0.558|TWO_SIDED||||||Regression, Linear|||Change in Gray Matter Perfusion vs. HOMA-IR|Adjusted R-square = 0|||0.558
91566099|NCT04089332|183020994|OTHER||Slope|-5.8089||||0.057|TWO_SIDED||||||Regression, Linear|||Baseline Gray Matter vs. HOMA-IR|Adjusted R-squared = 0.18|||0.057
91566100|NCT04089332|183020995|OTHER||Slope|-0.4465||||0.377|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.377
91566101|NCT04089332|183020995|OTHER||Slope|0.6704||||0.402|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.402
91566102|NCT04089332|183020995|OTHER||Slope|-0.8486||||0.203|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs. Cerebral Blood Flow|Adjusted R-squared = 0.207|||0.203
91566103|NCT04089332|183020995|OTHER||Slope|-0.0266||||0.967|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.967
91566104|NCT04089332|183020995|OTHER||Slope|-0.1588||||0.616|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.616
91566105|NCT04089332|183020995|OTHER||Slope|0.099||||0.287|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. Cerebral Blood Flow|Adjusted R-squared = 0.0497|||0.287
91566106|NCT04089332|183020995|OTHER||Slope|0.0676||||0.225|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. Cerebral Blood Flow|Adjusted R-squared = 0.106|||0.225
91566107|NCT04089332|183020995|OTHER||Slope|-0.0091||||0.872|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.872
91566108|NCT04089332|183020995|OTHER||Slope|-4.2085||||0.66|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.66
91566109|NCT05401149|183021002|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.35|2.59|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.59|1.35|<0.001
91566110|NCT05401149|183021003|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.43||||0.054|TWO_SIDED|95.0|0.99|2.06|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.06|0.99|0.054
91566111|NCT05401149|183021004|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.07||||0.097|TWO_SIDED|95.0|0.88|4.86|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||4.86|0.88|0.097
91566112|NCT05401149|183021005|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.48|2.75|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.75|1.48|<0.001
91566113|NCT05401149|183021006|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the ordinal logistic regression models with adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|0.77||||0.007|TWO_SIDED|95.0|0.64|0.93|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||0.93|0.64|0.007
91566114|NCT05401149|183021007|OTHER|Hazard ratio (HR) (95% Confidence Interval) and P values were derived from the cox proportional hazards models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Hazard Ratio (HR)|1.26||||0.077|TWO_SIDED|95.0|0.98|1.64|||Regression, Cox||IV rt-PA cohort/Non-reperfusion cohort|||1.64|0.98|0.077
91566115|NCT04281875|183021014|SUPERIORITY|||||||0.6905|||||||t-test, 2 sided|||||||0.6905
91566116|NCT01231464|183021037|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.498|||<|0.0001|TWO_SIDED|95.0|-1.897|-1.009|||ANCOVA||Besides treatment, the ANCOVA analysis also adjusted for baseline, center, gender, age, and classification of AR (Intermittent Allergic Rhinitis \[IAR\] or Persistent Allergic Rhinitis \[PER\]).|||-1.009|-1.897|<0.0001
91566117|NCT03245762|183021108|SUPERIORITY||Odds Ratio (OR)|0.9||||0.93|TWO_SIDED||||||Ordinal Categorical Analysis|||||||0.930
91566118|NCT00637247|183021109|SUPERIORITY_OR_OTHER|||||||0.2|||||||Log Rank|||The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.||||0.2
91566119|NCT01907113|183021113|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.24|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.17|145.38|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||145.38|96.17|
91566120|NCT01907113|183021113|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|119.94|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.25|149.47|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||149.47|96.25|
91566121|NCT01907113|183021113|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|166.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|134.44|205.68|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||205.68|134.44|
91566122|NCT01907113|183021113|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|148.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|119.89|183.42|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||183.42|119.89|
91566123|NCT01907113|183021114|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.83|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|93.62|150.84|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||150.84|93.62|
91566124|NCT01907113|183021114|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|102.27|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|79.33|131.85|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||131.85|79.33|
91566125|NCT01907113|183021114|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|120.68|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|94.42|154.25|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||154.25|94.42|
91566126|NCT01907113|183021114|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|103.75|STANDARD_DEVIATION|29.7|||TWO_SIDED|95.0|81.18|132.61|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||132.61|81.18|
91566127|NCT00922441|183021145|OTHER|Efficacy, Safety|||||<|0.05|||||||ANOVA|comparison between the groups||||||<0.05
91566128|NCT00843115|183021187|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
91566129|NCT00843115|183021188|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
91566130|NCT00843115|183021189|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566131|NCT00843115|183021190|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566132|NCT00843115|183021191|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566133|NCT00843115|183021192|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566134|NCT00843115|183021193|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566135|NCT00843115|183021194|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566136|NCT00843115|183021195|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566137|NCT00843115|183021196|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566138|NCT00843115|183021197|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566139|NCT00843115|183021198|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566140|NCT00843115|183021199|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566141|NCT00843115|183021200|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566142|NCT00843115|183021201|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566143|NCT00843115|183021202|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566144|NCT00843115|183021203|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566145|NCT00843115|183021204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566146|NCT00843115|183021205|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566147|NCT00843115|183021206|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566148|NCT00843115|183021207|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
91566149|NCT00843115|183021208|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||Change from baseline in total score at Week 12||||<0.0001
91566150|NCT00843115|183021209|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||Change from baseline in total score at Week 12 Last Observation Carried Forward||||<0.0001
91566151|NCT00843115|183021210|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|P value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
91566152|NCT00843115|183021211|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
91566153|NCT00843115|183021212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
91566154|NCT00843115|183021213|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||<0.0001
91566155|NCT00843115|183021214|SUPERIORITY_OR_OTHER|||||||0.0713|||||||correlation coefficient|||||||0.0713
91566156|NCT00843115|183021215|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Correlation coefficient|||||||0.0225
91566157|NCT00843115|183021216|SUPERIORITY_OR_OTHER|||||||0.0152|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||0.0152
91566158|NCT00843115|183021217|SUPERIORITY_OR_OTHER|||||||0.0229|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||0.0229
91566159|NCT00843115|183021218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
91566160|NCT00843115|183021219|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
91566161|NCT00843115|183021220|SUPERIORITY_OR_OTHER|||||||0.7963|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12."||||||0.7963
91566162|NCT00843115|183021221|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||1.0000
91566163|NCT00843115|183021222|SUPERIORITY_OR_OTHER|||||||0.0719|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0719
91566164|NCT00843115|183021223|SUPERIORITY_OR_OTHER|||||||0.1779|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||0.1779
91566165|NCT00843115|183021224|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
91566166|NCT00843115|183021225|SUPERIORITY_OR_OTHER|||||||0.8575|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.8575
91566167|NCT00843115|183021226|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
91566168|NCT00843115|183021227|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||1.0000
91566169|NCT00843115|183021228|SUPERIORITY_OR_OTHER|||||||0.0131|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0131
91566170|NCT00843115|183021229|SUPERIORITY_OR_OTHER|||||||0.0078|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.0078
91566171|NCT02005029|183021230|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
91566172|NCT02005029|183021231|SUPERIORITY_OR_OTHER||Erythromycin:Placebo AUC ratio|1.07|STANDARD_DEVIATION|0.43|||TWO_SIDED|||||||||||||
91566173|NCT02005029|183021232|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
91566174|NCT02005029|183021233|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
91566175|NCT02005029|183021234|SUPERIORITY_OR_OTHER|||||||0.4405|||||||t-test, 2 sided|||||||0.4405
91566176|NCT02005029|183021235|SUPERIORITY_OR_OTHER|||||||0.6011|||||||t-test, 2 sided|||||||0.6011
91566177|NCT02005029|183021236|SUPERIORITY_OR_OTHER|||||||0.8923|||||||t-test, 2 sided|||||||0.8923
91566178|NCT02005029|183021237|SUPERIORITY_OR_OTHER|||||||0.832|||||||t-test, 2 sided|||||||0.832
91566179|NCT02005029|183021238|SUPERIORITY_OR_OTHER|||||||0.1546|||||||t-test, 2 sided|||||||0.1546
91566180|NCT02005029|183021239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|STANDARD_DEVIATION|5.0||0.0314|TWO_SIDED||||||t-test, 2 sided||"Mean difference in on score versus off score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on score versus off score on day of placebo."|||||0.0314
91566181|NCT02005029|183021240|SUPERIORITY_OR_OTHER||Erythromycin:Placebo Cmax ratio|0.83|STANDARD_DEVIATION|0.24|||TWO_SIDED|||||||||||||
91566182|NCT02621047|183021241|SUPERIORITY_OR_OTHER||Geometric Mean Ratio Percentage (%)|128.0|||||TWO_SIDED|90.0|86.5|188.0||||||||188|86.5|
91566183|NCT02621047|183021241|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|100.0|||||TWO_SIDED|90.0|55.1|183.0||||||||183|55.1|
91566184|NCT02621047|183021242|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|148.0|||||TWO_SIDED|90.0|106.0|208.0||||||||208|106|
91566185|NCT02621047|183021242|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|130.0|||||TWO_SIDED|90.0|75.4|225.0||||||||225|75.4|
91566186|NCT02621047|183021243|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|160.0||||||90.0|105.0|243.0||||||||243|105|
91566187|NCT02621047|183021243|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|220.0||||||90.0|131.0|369.0||||||||369|131|
91566188|NCT02621047|183021244|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|186.0||||||90.0|122.0|281.0||||||||281|122|
91566189|NCT02621047|183021244|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|285.0||||||90.0|175.0|466.0||||||||466|175|
91566190|NCT02621047|183021245|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|162.0|||||TWO_SIDED|90.0|104.0|254.0||||||||254|104|
91566191|NCT02621047|183021245|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|228.0||||||90.0|129.0|403.0||||||||403|129|
91566192|NCT02621047|183021246|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|189.0||||||90.0|121.0|293.0||||||||293|121|
91566193|NCT02621047|183021246|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|296.0|||||TWO_SIDED|90.0|174.0|506.0||||||||506|174|
91566194|NCT02621047|183021247|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|64.6||||||90.0|36.2|115.0||||||||115|36.2|
91566195|NCT02621047|183021247|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|60.8|||||TWO_SIDED|90.0|26.6|139.0||||||||139|26.6|
91566196|NCT02621047|183021248|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|85.1||||||90.0|55.5|130.0||||||||130|55.5|
91566197|NCT02621047|183021248|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|59.0||||||90.0|34.2|102.0||||||||102|34.2|
91566198|NCT02621047|183021249|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|116.0||||||90.0|78.6|172.0||||||||172|78.6|
91566199|NCT02621047|183021249|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|98.1||||||90.0|51.7|186.0||||||||186|51.7|
91566200|NCT02621047|183021250|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|115.0|||||TWO_SIDED|90.0|85.2|154.0||||||||154|85.2|
91566201|NCT02621047|183021250|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6|||||TWO_SIDED|90.0|55.6|168.0||||||||168|55.6|
91566202|NCT02621047|183021251|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|80.6||||||90.0|50.2|130.0||||||||130|50.2|
91566203|NCT02621047|183021251|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|65.6|||||TWO_SIDED|90.0|26.9|160.0||||||||160|26.9|
91566204|NCT02621047|183021252|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|104.0||||||90.0|76.8|141.0||||||||141|76.8|
91566205|NCT02621047|183021252|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|63.7|||||TWO_SIDED|90.0|34.0|119.0||||||||119|34.0|
91566206|NCT02621047|183021253|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|136.0|||||TWO_SIDED|90.0|94.7|196.0||||||||196|94.7|
91566207|NCT02621047|183021253|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|176.0||||||90.0|98.4|315.0||||||||315|98.4|
91566208|NCT02621047|183021254|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|134.0||||||90.0|99.6|181.0||||||||181|99.6|
91566209|NCT02621047|183021254|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|157.0|||||TWO_SIDED|90.0|91.8|268.0||||||||268|91.8|
91566210|NCT02621047|183021255|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|73.3|||||TWO_SIDED|90.0|46.2|116.0||||||||116|46.2|
91566211|NCT02621047|183021255|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|57.5|||||TWO_SIDED|90.0|20.0|165.0||||||||165|20.0|
91566212|NCT02621047|183021256|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6||||||90.0|69.9|134.0||||||||134|69.9|
91566213|NCT02621047|183021256|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|55.8||||||90.0|26.0|120.0||||||||120|26.0|
91566214|NCT02621047|183021257|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|139.0|||||TWO_SIDED|90.0|94.8|203.0||||||||203|94.8|
91566215|NCT02621047|183021257|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|180.0||||||90.0|97.2|334.0||||||||334|97.2|
91566216|NCT02621047|183021258|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|137.0|||||TWO_SIDED|90.0|100.0|186.0||||||||186|100|
91566217|NCT02621047|183021258|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|158.0|||||TWO_SIDED|90.0|91.2|274.0||||||||274|91.2|
91566218|NCT02109107|183021312|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|t=21.33; df=53||||||<.0001
91566219|NCT02109107|183021313|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|t=2.95; df=53||||||<0.05
91566220|NCT02109107|183021314|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||t-test, 2 sided|t+3.34; df=53||||||<0.005
91566221|NCT02264353|183021322|SUPERIORITY|||||||0.576|||||||t-test, 2 sided|||||||0.576
91566222|NCT02264353|183021323|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||0.394
91566223|NCT02264353|183021324|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
91566224|NCT02963922|183021404|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised participants regardless of premature discontinuation of trial product.|Treatment difference|-4.32|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.48|-3.16|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.||-3.16|-5.48|< .0001
91566225|NCT02963922|183021404|SUPERIORITY|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised participants assuming that all participants remained on trial product (on-treatment principle).|Treatment difference|-5.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-6.3|-3.91|||MMRM||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.||-3.91|-6.30|< .0001
91566226|NCT02963922|183021405|SUPERIORITY||Odds Ratio (OR)|3.41|||<|0.0001|TWO_SIDED|95.0|2.19|5.31|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.||5.31|2.19|<.0001
91566227|NCT02963922|183021405|SUPERIORITY||Odds Ratio (OR)|4.73|||<|0.0001|TWO_SIDED|95.0|3.04|7.36|||Mixed model for repeated measurements||Liraglutide 3.0 mg/Placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||7.36|3.04|<.0001
91566228|NCT02181400|183021459|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
91566229|NCT02181400|183021460|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
91566230|NCT02181400|183021461|OTHER|||||||0.12|||||||ANCOVA|||||||0.12
91566231|NCT02181400|183021462|OTHER|||||||0.32|||||||ANCOVA|||||||0.32
91566232|NCT02181400|183021463|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
91566233|NCT02181400|183021464|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
91566234|NCT03873038|183021493|OTHER|Geometric mean ratio (GMR) was derived using the geometric mean (GM) for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.8|||||TWO_SIDED|90.0|0.54|1.18|||||GMR=GM ESRD/GM Healthy|||1.18|0.54|
91566235|NCT03873038|183021493|OTHER|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.53|||||TWO_SIDED|90.0|0.37|0.76|||||GMR=GM ESRD/GM Healthy|||0.76|0.37|
91566236|NCT03873038|183021493|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.55|1.21|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.21|0.55|
91566237|NCT03873038|183021494|OTHER||GMR|1.41|||||TWO_SIDED|90.0|1.07|1.85|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.85|1.07|
91566238|NCT03873038|183021494|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.67|1.11|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001)||1.11|0.67|
91566239|NCT03873038|183021494|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.62|1.08|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.08|0.62|
91566240|NCT03873038|183021495|OTHER||GMR|1.11|||||TWO_SIDED|90.0|0.84|1.46|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.46|0.84|
91566241|NCT03873038|183021495|OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.52|0.87|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||0.87|0.52|
91566242|NCT03873038|183021495|OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.6|1.03|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.03|0.60|
91566243|NCT03873038|183021496|OTHER||GMR|1.5|||||TWO_SIDED|90.0|1.05|2.14|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||2.14|1.05|
91566244|NCT03873038|183021496|OTHER||GMR|0.91|||||TWO_SIDED|90.0|0.67|1.25|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.25|0.67|
91566245|NCT03873038|183021496|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.62|1.2|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.20|0.62|
91566246|NCT00595764|183021511|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|||||ANOVA|||With an effect size of 0.46, a sample size of 140 will provide a power of \>.84 with p\<.05 to detect overall differences between the two treatments on the primary outcome measures.||||.91
91566247|NCT00595764|183021513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.32||0.29|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.29
91566248|NCT00595764|183021514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.029||0.58|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.58
91566249|NCT00595764|183021515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|3.63||0.24|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.24
91566250|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6409||||||Hochberg's adjustment was used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6409
91566251|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0140
91566252|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4840
91566253|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4444||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4444
91566254|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8129||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8129
91566255|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.1105
91566256|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9582||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9582
91566257|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1893||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1893
91566258|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2924||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Hochberg's adjustment used for multiple comparisons adjustment||Week 5||||0.2924
91566259|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1897||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.1897
91566260|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6608||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.6608
91566261|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2148||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.2148
91566262|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.5290
91566263|NCT00141271|183021522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0811||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.0811
91566264|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2287
91566265|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4734||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week1||||0.4734
91566266|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7401||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7401
91566267|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7904||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7904
91566268|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5274||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.5274
91566269|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1059||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.1059
91566270|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8871||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8871
91566271|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6939|||||||Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.6939
91566272|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1044||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.1044
91566273|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3132||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.3132
91566274|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6978
91566275|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3228
91566276|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6432
91566277|NCT00141271|183021523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5989||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.5989
91566278|NCT00141271|183021524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8921||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.8921
91566279|NCT00141271|183021524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4350
91566280|NCT00141271|183021524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.562||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5620
91566281|NCT00141271|183021524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6959||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6959
91566282|NCT00141271|183021524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7865||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7865
91566283|NCT00141271|183021524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7564
91566284|NCT00141271|183021525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4327||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4327
91566285|NCT00141271|183021525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7041||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7041
91566286|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2076||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2076
91566287|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7449||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.7449
91566288|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4399||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.4399
91566289|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7107||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7107
91566290|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4765||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4765
91566291|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2564
91566292|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8063||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8063
91566293|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9855||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.9855
91566294|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0599||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0599
91566295|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7364||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.7364
91566296|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.3048
91566297|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5139||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.5139
91566298|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9356||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9356
91566299|NCT00141271|183021526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9428
91566300|NCT00141271|183021527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3888
91566301|NCT00141271|183021527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3122||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3122
91566302|NCT00141271|183021527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3323
91566303|NCT00141271|183021527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8781||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.8781
91566304|NCT00141271|183021527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9485||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9485
91566305|NCT00141271|183021527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7331||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7331
91566306|NCT00141271|183021528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.4869
91566307|NCT00141271|183021528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5813||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.5813
91566308|NCT00141271|183021528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.3303
91566309|NCT00141271|183021528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1546||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.1546
91566310|NCT00141271|183021528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8982||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.8982
91566311|NCT00141271|183021528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3586
91566312|NCT00141271|183021529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0896||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.0896
91566313|NCT00141271|183021529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6534||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6534
91566314|NCT00141271|183021529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.3270
91566315|NCT00141271|183021529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4099
91566316|NCT00141271|183021529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6104||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6104
91566317|NCT00141271|183021529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9359||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9359
91566318|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6924||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6924
91566319|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0800
91566320|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4238||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4238
91566321|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7714||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.7714
91566322|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8731||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8731
91566323|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8926
91566324|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2072||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.2072
91566325|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1042
91566326|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2695||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.2695
91566327|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3245
91566328|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7791||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.7791
91566329|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0999||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.0999
91566330|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9543||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.9543
91566331|NCT00141271|183021530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3153
91566332|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2878||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.2878
91566333|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4481||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.4481
91566334|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4099
91566335|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5093||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 2||||0.5093
91566336|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 3||||0.8048
91566337|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0552
91566338|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9795||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9795
91566339|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5073||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.5073
91566340|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4882
91566341|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3967||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3967
91566342|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8276||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8276
91566343|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8502||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8502
91566344|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6343||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6343
91566345|NCT00141271|183021531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3082
91566346|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6932
91566347|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0287
91566348|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2128||95.0||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.2128
91566349|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1118||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.1118
91566350|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.6144
91566351|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0899
91566352|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8819||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8819
91566353|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8374
91566354|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3925||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3925
91566355|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4182||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4182
91566356|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8586
91566357|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.5490
91566358|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6292||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6292
91566359|NCT00141271|183021532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1473||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.1473
91566360|NCT00141271|183021533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.2058
91566361|NCT00141271|183021533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9254||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.9254
91566362|NCT00141271|183021533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5071||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.5071
91566363|NCT00141271|183021533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2858||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2858
91566364|NCT00141271|183021533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6298||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6298
91566365|NCT00141271|183021533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6034
91566366|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1454||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.1454
91566367|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2672||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 1||||0.2672
91566368|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2614||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 2||||0.2614
91566369|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.2143
91566370|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.6997
91566371|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0128
91566372|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1144
91566373|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1483
91566374|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0674||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0674
91566375|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.2900
91566376|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5482||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5482
91566377|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.0303
91566378|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6143
91566379|NCT00141271|183021534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3385||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.3385
91566380|NCT00141271|183021535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3299||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3299
91566381|NCT00141271|183021535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1915||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1915
91566382|NCT00141271|183021536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5407||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5407
91566383|NCT00141271|183021536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6079||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6079
91566384|NCT00141271|183021537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8464
91566385|NCT00141271|183021537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.4023
91566386|NCT00141271|183021537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2870
91566387|NCT00141271|183021537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2537
91566388|NCT00141271|183021537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7909||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7909
91566389|NCT00141271|183021537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3308||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3308
91566390|NCT00141271|183021538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3355||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.3355
91566391|NCT00141271|183021538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8447||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8447
91566392|NCT00141271|183021538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8959||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.8959
91566393|NCT00141271|183021538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4826||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4826
91566394|NCT00141271|183021538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4178||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4178
91566395|NCT00141271|183021538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8277||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8277
91566396|NCT00141271|183021539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7758||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.7758
91566397|NCT00141271|183021539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8737
91566398|NCT00141271|183021539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1151
91566399|NCT00141271|183021539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1290
91566400|NCT00141271|183021539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4432
91566401|NCT00141271|183021539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2988||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2988
91566402|NCT00141271|183021540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8598||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8598
91566403|NCT00141271|183021540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6513||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6513
91566404|NCT00141271|183021540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6272||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6272
91566405|NCT00141271|183021540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6467||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6467
91566406|NCT00141271|183021540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8049||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8049
91566407|NCT00141271|183021540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9411||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.9411
91566408|NCT00141271|183021541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9260
91566409|NCT00141271|183021541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7100
91566410|NCT00141271|183021542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1836||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1836
91566411|NCT00141271|183021542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1374
91566412|NCT00141271|183021543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9237||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9237
91566413|NCT00141271|183021543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3786||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3786
91566414|NCT00141271|183021544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4624||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4624
91566415|NCT00141271|183021544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5971|||||||ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5971
91566416|NCT00141271|183021545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1378
91566417|NCT00141271|183021545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7665
91566418|NCT00141271|183021546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4767||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.4767
91566419|NCT00141271|183021546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2066||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2066
91566420|NCT00141271|183021547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1667||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1667
91566421|NCT00141271|183021547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6727||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6727
91566422|NCT00141271|183021548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7019||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7019
91566423|NCT00141271|183021548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1020
91566424|NCT00141271|183021549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4749||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4749
91566425|NCT00141271|183021549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4491||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4491
91566426|NCT00141271|183021550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4398||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4398
91566427|NCT00141271|183021550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3331
91566428|NCT00141271|183021551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2763||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2763
91566429|NCT00141271|183021551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2048||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2048
91566430|NCT00141271|183021552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4340
91566431|NCT00141271|183021552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.7774
91566432|NCT00141271|183021553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.5195
91566433|NCT00141271|183021553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.0153
91566434|NCT00141271|183021554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2847||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2847
91566435|NCT00141271|183021554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1958||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1958
91566436|NCT00141271|183021555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1652||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1652
91566437|NCT00141271|183021555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5997
91566438|NCT00141271|183021556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.0082
91566439|NCT00141271|183021556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7037||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7037
91566440|NCT00141271|183021557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2718||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2718
91566441|NCT00141271|183021557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7077||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7077
91566442|NCT00141271|183021558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5057
91566443|NCT00141271|183021558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3654
91566444|NCT00141271|183021559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6227||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6227
91566445|NCT00141271|183021559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7737||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7737
91566446|NCT00390806|183021567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.1862|TWO_SIDED|95.0|0.73|1.07||p-value from a stratified log-rank test is adjusted for Recursive Partitioning Analysis (RPA) class and the number of brain lesions at Screening.|Log Rank||The hazard ratio is estimated using a Pike estimator. The hazard ratio from a stratified log-rank test is adjusted for RPA class and the number of brain lesions at Screening.|||1.07|0.73|0.1862
91566447|NCT04783519|183021610|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.127|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-0.127|-0.650|.004
91566448|NCT04783519|183021610|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.21||||0.118|TWO_SIDED|95.0|-0.482|0.054|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||.054|-.482|.118
91566449|NCT04783519|183021610|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.41||||0.003|TWO_SIDED|95.0|-0.674|-0.142|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||-0.142|-0.674|.003
91566450|NCT04783519|183021610|SUPERIORITY||beta coefficient|-0.16||||0.24|TWO_SIDED|95.0|-0.428|0.107|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.107|-0.428|.240
91566451|NCT04783519|183021611|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.88||||0.003|TWO_SIDED|95.0|-8.1|-1.65|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-1.65|-8.10|.003
91566452|NCT04783519|183021611|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-1.71||||0.308|TWO_SIDED|95.0|-4.98|1.57|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||1.57|-4.98|.308
91566453|NCT04783519|183021611|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.52||||0.007|TWO_SIDED|95.0|-7.8|-1.25|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to 3 Month for BASICS+SLEEP vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||-1.25|-7.8|.007
91566454|NCT04783519|183021611|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.83||||0.621|TWO_SIDED|95.0|-4.12|2.46|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month for BASICS vs. AOC reported in this section. Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/ )||2.46|-4.12|.621
91566455|NCT04783519|183021612|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.802||||0.054|TWO_SIDED|95.0|0.641|1.003|||Mixed Models Analysis|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.003|0.641|.054
91566456|NCT04783519|183021612|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.75||||0.015|TWO_SIDED|95.0|0.6|0.946|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.946|0.600|.015
91566457|NCT04783519|183021612|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.736||||0.013|TWO_SIDED|95.0|0.578|0.937|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.937|0.578|.013
91566458|NCT04783519|183021612|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.658||||0.001|TWO_SIDED|95.0|0.513|0.844|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.844|0.513|.001
91566459|NCT04783519|183021613|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.992||||0.96|TWO_SIDED|95.0|0.716|1.374|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.374|0.716|.960
91566460|NCT04783519|183021613|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.782||||0.152|TWO_SIDED|95.0|0.506|1.094|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.094|0.506|.152
91566461|NCT04783519|183021613|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.887||||0.482|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.240|0.634|.482
91566462|NCT04783519|183021613|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.67||||0.02|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||1.240|0.634|.020
91566463|NCT04783519|183021614|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.724||||0.032|TWO_SIDED|95.0|0.54|0.973|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.973|0.540|.032
91566464|NCT04783519|183021614|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.588|||<|0.001|TWO_SIDED|95.0|0.432|0.8|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.800|0.432|<.001
91566465|NCT04783519|183021615|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.699||||0.009|TWO_SIDED|95.0|0.535|0.914|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.914|0.535|.009
91566466|NCT04783519|183021615|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.675||||0.005|TWO_SIDED|95.0|0.512|0.888|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.888|0.512|.005
91566467|NCT04783519|183021615|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.698||||0.013|TWO_SIDED|95.0|0.526|0.928|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.928|0.526|.013
91566468|NCT04783519|183021615|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.525|||<|0.001|TWO_SIDED|95.0|0.385|0.715|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.715|0.385|<.001
91566469|NCT04783519|183021616|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.598||||0.01|TWO_SIDED|95.0|0.404|0.885|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.885|0.404|.010
91566470|NCT04783519|183021616|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.502||||0.001|TWO_SIDED|95.0|0.331|0.76|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.760|0.331|.001
91566471|NCT04783519|183021616|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.516||||0.002|TWO_SIDED|95.0|0.337|0.79|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.790|0.337|.002
91566472|NCT04783519|183021616|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.506||||0.002|TWO_SIDED|95.0|0.33|0.774|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.774|0.330|.002
91566473|NCT04783519|183021617|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.628||||0.003|TWO_SIDED|95.0|0.462|0.853|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.853|0.462|.003
91566474|NCT04783519|183021617|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.744||||0.073|TWO_SIDED|95.0|0.538|1.028|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.028|0.538|.073
91566475|NCT04783519|183021617|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.764||||0.09|TWO_SIDED|95.0|0.559|1.043|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.043|0.559|.090
91566476|NCT04783519|183021617|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.656||||0.013|TWO_SIDED|95.0|0.469|0.916|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.916|0.469|.013
91566477|NCT04783519|183021618|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.753||||0.087|TWO_SIDED|95.0|0.546|1.041|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.041|0.546|.087
91566478|NCT04783519|183021618|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.739||||0.078|TWO_SIDED|95.0|0.528|1.034|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.034|0.528|.078
91566479|NCT04783519|183021618|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.773||||0.099|TWO_SIDED|95.0|0.569|1.05|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.050|0.569|.099
91566480|NCT04783519|183021618|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.704||||0.031|TWO_SIDED|95.0|0.512|0.969|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.969|0.512|.031
91566481|NCT04341584|183021626|SUPERIORITY||Median posterior HR|0.97|||||TWO_SIDED|90.0|0.62|1.52|||Bayesian Cox model|adjusted for age and centre|% Confidence Interval is % Credible Interval here|||1.52|0.62|
91566482|NCT04341584|183021627|SUPERIORITY||Median posterior absolute risk differenc|-2.5|||||TWO_SIDED|90.0|-17.1|12.0|||Bayesian analysis||% Confidence Interval is % Credible Interval here|||12|-17.1|
91566483|NCT04341584|183021628|SUPERIORITY||Median posterior HR|1.26|||||TWO_SIDED|90.0|0.59|2.81||adjusted for age and centre|Bayesian Fine and Gray analysis||% Confidence interval is % Credible Interval here|||2.81|0.59|
91566484|NCT04341584|183021629|SUPERIORITY||Median posterior absolute risk differenc|24.0|||||TWO_SIDED|90.0|3.9|43.5|||Bayesian analysis||% Confidence interval is % Credible interval here|||43.5|3.9|
91566485|NCT04341584|183021630|SUPERIORITY||Median posterior OR|0.8|||||TWO_SIDED|95.0|0.38|1.68|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 4||1.68|0.38|
91566486|NCT04341584|183021630|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.33|1.43|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 14||1.43|0.33|
91566487|NCT04341584|183021630|SUPERIORITY||Median posterior OR|0.7|||||TWO_SIDED|95.0|0.35|1.38|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 28||1.38|0.35|
91566488|NCT04341584|183021630|SUPERIORITY||Median posterior OR|0.72|||||TWO_SIDED|95.0|0.22|2.39|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 4||2.39|0.22|
91566489|NCT04341584|183021630|SUPERIORITY||Median posterior HR|0.89|||||TWO_SIDED|95.0|0.28|2.8|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 7||2.80|0.28|
91566490|NCT04341584|183021630|SUPERIORITY||Median posterior HR|0.57|||||TWO_SIDED|95.0|0.18|1.75||Day 14|Bayesian Proportionnal odds model|Adjusted for afe and centre|% Confidence Interval is % Credible interval here|||1.75|0.18|
91566491|NCT04341584|183021631|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.23|1.29|||Regression, Cox|adjusted for age and centre||14 days||1.29|0.23|
91566492|NCT04341584|183021631|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.33|1.77|||Regression, Cox|Adjusted for age and centre||28 days||1.77|0.33|
91566493|NCT04341584|183021631|SUPERIORITY|90 days|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.46|2.04|||Regression, Cox|adjusted on age and centre|% Confidence interval is % Credible interval here|||2.04|0.46|
91566494|NCT04341584|183021631|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.11|3.86|||Regression, Cox|adjusted on age and centre||||3.86|0.11|
91566495|NCT04341584|183021631|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||Regression, Cox|adjusted on age and centre||||4.68|0.19|
91566496|NCT04341584|183021631|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.31|4.87|||Regression, Cox|adjusted on age and centre||||4.87|0.31|
91566497|NCT04341584|183021632|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-8.3|6.4||||adjusted on age and centre||||6.4|-8.3|
91566498|NCT04341584|183021634|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.61|||Fine-Gray model|Adjusted for age and centre||||1.61|0.64|
91566499|NCT04341584|183021634|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.58|3.07||Adjusted for age and centre|Fine-Gray model|Adjusted for age and centre||||3.07|0.58|
91566500|NCT04341584|183021635|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.56|1.48|||Fine-Gray model|adjusted on age and centre||||1.48|0.56|
91566501|NCT04341584|183021635|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.35|2.34||adjusted on age and centre|Fine-Gray model|||||2.34|0.35|
91566502|NCT04341584|183021636|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.43|2.32||adjusted on age and centre|Fine-Gray model|||Day 28||2.32|0.43|
91566503|NCT04341584|183021636|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.52|2.29||adjusted on age and centre|Fine-Gray model|||Day 90||2.29|0.52|
91566504|NCT01990313|183021682|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||||||0.038
91566505|NCT00510198|183021717|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Log Rank|||This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.||||0.23
91566506|NCT00510198|183021718|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 7.5%|Risk Difference (RD)|4.7||||0.36|TWO_SIDED|95.0|-10.9|20.3||The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Two-sample test of proportions||The risk difference estimate is the difference between the Access Arm and Control arm.|||20.3|-10.9|0.36
91566507|NCT00307164|183021738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Stratified Wilcoxon rank-sum test|Treatment groups were compared for change in limb fat using a two-sided stratified Wilcoxon rank-sum test (stratified by ARV used)||||||0.64
91566508|NCT00307164|183021739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Log Rank|||||||0.17
91566509|NCT00307164|183021741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.25
91566510|NCT00307164|183021743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.88
91566511|NCT00307164|183021744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.60
91566512|NCT00307164|183021745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.13
91566513|NCT00307164|183021746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
91566514|NCT00307164|183021747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.034
91566515|NCT00307164|183021748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.76
91566516|NCT00307164|183021749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.10
91566517|NCT00307164|183021750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.43
91566518|NCT00307164|183021751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
91566519|NCT00307164|183021752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.80
91566520|NCT00307164|183021753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.42
91566521|NCT03972137|183021763|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline (BL) to Quit Day.|Mean Difference (Final Values)|11.42|STANDARD_DEVIATION|6.08||0.003|TWO_SIDED|95.0|5.79|17.05||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and Quit Date (Mean CPD at Baseline - Mean CPD at Quit Date).|||17.05|5.79|.003
91566522|NCT03972137|183021763|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU).|Mean Difference (Final Values)|11.9|STANDARD_DEVIATION|8.45||0.067|TWO_SIDED|95.0|-1.55|25.35||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||25.35|-1.55|.067
91566523|NCT03972137|183021764|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total score from baseline (BL) to 2-weeks post-quit (2W).|Mean Difference (Final Values)|19.67|STANDARD_DEVIATION|11.91||0.01|TWO_SIDED|95.0|7.17|32.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 2-weeks post-quit. Estimated value reported is reflective of the n=6 participants that attended the 2-weeks post quit session.|||32.17|7.17|.010
91566524|NCT03972137|183021764|OTHER|A paired-samples t-test was conducted to examine the difference in DASS-21 Total scores from baseline (BL) to 1-month post-quit (1M).|Mean Difference (Final Values)|31.2|STANDARD_DEVIATION|20.4||0.027|TWO_SIDED|95.0|5.88|56.52||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 1-month post-quit. Estimated value reported is reflective of the n=5 participants that attended the 1-month post-quit session.|||56.52|5.88|.027
91566525|NCT03972137|183021764|OTHER|A paired-samples t-test was conducted to evaluate the difference in DASS-21 total scores from baseline (BL) to 3-month follow up (3MFU).|Mean Difference (Final Values)|25.75|STANDARD_DEVIATION|15.5||0.045|TWO_SIDED|95.0|1.09|50.41||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||50.41|1.09|.045
91566526|NCT02747121|183021777|OTHER|The intervention was external inspections. This is an organizational level intervention and it does not replace any existing intervention.|Odds Ratio (OR)|1.25||||0.24|TWO_SIDED|95.0|0.86|1.8||We used calculated P-values, however only confidence intervals were reported in the published article.|Mixed Models Analysis|||||1.80|0.86|0.24
91566527|NCT03029234|183021779|OTHER|The prespecified threshold that the primary endpoint would be met was if the lower limit of the 95% confidence interval (CI) was greater than 18%.|Overall response rate|35.8|||||TWO_SIDED|95.0|27.3|44.9||||||||44.9|27.3|
91566528|NCT03214250|183021877|SUPERIORITY|One-sided|probability|0.577||||0.006|ONE_SIDED|95.0|0.417|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.417|0.006
91566529|NCT03214250|183021877|SUPERIORITY|One-sided|probability|0.481||||0.062|ONE_SIDED|95.0|0.337|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.337|0.062
91566530|NCT03214250|183021877|SUPERIORITY|One-sided|probability|0.413||||0.233|ONE_SIDED|95.0|0.27|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.270|0.233
91566531|NCT02487251|183021884|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.15||||0.34|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in BMIz is p = .34.|Mixed Models Analysis||The reported estimation parameter is the effect size (cohen's d) for the change in BMIz (particularly in the Phase 2 sample)|We tested change in BMIz for each of the four study arms/groups.||||.34
91566532|NCT02487251|183021885|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|-0.07||||0.62|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed fruit intake is p = .62.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in observed fruit intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups.||||.62
91566533|NCT02487251|183021886|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed vegetable intake is p = .009.|Mixed Models Analysis|||We tested pre to post change in observed vegetable intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups. Positive Observed dietary quality data was not collected in Phase 1.||||.009
91566534|NCT02487251|183021887|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.15||||0.21|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported fruit is p = .21.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested pre to post change in parent reported child fruit intake for each of the four study arms/groups.||||.21
91566535|NCT02487251|183021888|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.07||||0.55|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported vegetables is p = .55.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in vegetable intake for each of the four study arms/groups.||||.55
91566536|NCT02487251|183021889|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.02||||0.84|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in mealtime frequency is p = .84.|Mixed Models Analysis|||We tested change in frequency of family mealtimes for each of the four study arms/groups.||||.84
91566537|NCT02845375|183021892|SUPERIORITY|||||||0.299|||||||ANCOVA|||||||0.299
91566538|NCT01951261|183021906|NON_INFERIORITY|sample size calculation was made, considering it appropriate to set a limit of non-inferiority with respect to the main variable of 1.2 months (36 days), the study being lower if it will have exacerbation before this period of time, with a follow-up of 6 months, It was required to include a sample of 58 patients per group for a potency of 80% and a significance level of 5%.|||||<|0.05||||||The reported p-value was calculated.Statistical analysis of the main variable was performed using the Kaplan-Meier method and log-rank test|Log Rank|||||||<0.05
91566539|NCT01287416|183021936|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of SIRI scores across the three time points. We used linear mixed models to determine whether scores were different between the two groups over time.||||0.61
91566540|NCT01287416|183021937|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.95
91566541|NCT01287416|183021938|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in terms of self-reported skill level across the three time points.||||0.33
91566542|NCT01287416|183021939|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.05.|Mixed Models Analysis|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.03
91566543|NCT01287416|183021940|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ on level of self-reported preparedness to help a suicidal person.||||0.63
91566544|NCT01287416|183021941|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for significance set to p\<.05.|ANCOVA|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ on their level of distress across the two time points.||||0.21
91566545|NCT01287416|183021942|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||A priori threshold for significance set at p\<.05.|ANCOVA|Model was adjusted for differences in educational attainment at baseline.||Null hypothesis was that the groups would not differ in terms of alcohol use across the two time points.||||0.46
91566546|NCT01287416|183021943|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||The a priori threshold for statistical significance was set at p\<.05.|ANCOVA|Model is adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in resiliency scores across the follow-up period.||||0.28
91566547|NCT01287416|183021944|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.33
91566548|NCT01287416|183021945|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.62
91566549|NCT01287416|183021946|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
91566550|NCT01287416|183021947|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
91566551|NCT01287416|183021948|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||0.064
91566552|NCT01287416|183021950|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||a priori threshold for significance set a p\<.05.|Fisher Exact|unadjusted model||Null hypothesis was that the groups would not differ in terms of their gatekeeper behaviours||||0.14
91566553|NCT01287416|183021951|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|Unadjusted model||Null hypothesis was that the groups would not differ on gatekeeper behaviours.||||0.41
91566554|NCT01180790|183021974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||||||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg, 400 mg, and 800 mg ACH-0141625.|exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of participants achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.||||0.003
91566555|NCT01180790|183021974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
91566556|NCT01180790|183021974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
91566557|NCT01180790|183021974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
91566558|NCT01180790|183021976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||||||To control for multiplicity, the proportion of participants in each treatment group achieving cEVR is analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625.|Exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of participants achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.||||0.34
91566559|NCT04167085|183021989|SUPERIORITY|||||||0.16||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.16
91566560|NCT04167085|183021990|SUPERIORITY|||||||0.05||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.05
91566561|NCT04167085|183021991|SUPERIORITY|||||||0.19||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.19
91566562|NCT04167085|183021992|SUPERIORITY|||||||0.24||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Physical||||0.24
91566563|NCT04167085|183021992|SUPERIORITY|||||||0.35||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Mental||||0.35
91566564|NCT04167085|183021993|SUPERIORITY|||||||0.5||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.50
91566565|NCT04167085|183021994|SUPERIORITY|||||||0.3||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.30
91566566|NCT04167085|183021995|SUPERIORITY|||||||1||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||1.00
91566567|NCT03840148|183021997|NON_INFERIORITY|If the lower limit of the 95% CI for the difference in response is greater than or equal to the non-inferiority margin of -15%, non-inferiority will be concluded. Further, if non-inferiority is concluded, superiority will be concluded if the lower limit of the 95% CI for the difference in response is greater than or equal to zero.|Miettinen and Nurminen|12.6||||0.0088|TWO_SIDED|95.0|3.1|22.2||P-value for superiority since the lower confidence interval is greater than 0 for the primary endpoint analysis.|Cochran-Mantel-Haenszel|||||22.2|3.1|0.0088
91566568|NCT03840148|183021998|OTHER||Miettinen and Nurminen|11.7|||||TWO_SIDED|95.0|2.9|21.0||||||||21.0|2.9|
91566569|NCT03840148|183021999|OTHER||Miettinen and Nurminen|4.5|||||TWO_SIDED|95.0|-2.6|12.6||||||||12.6|-2.6|
91566570|NCT03840148|183022000|OTHER||Miettinen and Nurminen|12.3|||||TWO_SIDED|95.0|3.0|21.8||||||||21.8|3.0|
91566571|NCT03840148|183022001|OTHER||Miettinen and Nurminen|3.1|||||TWO_SIDED|95.0|-3.2|10.4||||||||10.4|-3.2|
91566572|NCT03840148|183022002|OTHER||Miettinen and Nurminen|-0.3|||||TWO_SIDED|95.0|-3.5|4.1||||||||4.1|-3.5|
91566573|NCT03840148|183022003|OTHER||Miettinen and Nurminen|1.6|||||TWO_SIDED|95.0|-4.1|8.5||||||||8.5|-4.1|
91566574|NCT03840148|183022004|OTHER||Miettinen and Nurminen|12.1|||||TWO_SIDED|95.0|2.2|21.9||||||||21.9|2.2|
91566575|NCT03840148|183022005|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.6|17.3||||||||17.3|-1.6|
91566576|NCT03840148|183022006|OTHER||Miettinen and Nurminen|9.9|||||TWO_SIDED|95.0|1.5|18.8||||||||18.8|1.5|
91566577|NCT03840148|183022007|OTHER||Miettinen and Nurminen|3.0|||||TWO_SIDED|95.0|-2.4|9.6||||||||9.6|-2.4|
91566578|NCT03840148|183022017|OTHER||Miettinen and Nurminen|3.5|||||TWO_SIDED|95.0|-2.3|10.5||||||||10.5|-2.3|
91566579|NCT03840148|183022018|OTHER||Miettinen and Nurminen|-1.1|||||TWO_SIDED|95.0|-3.1|1.7||||||||1.7|-3.1|
91566580|NCT03840148|183022019|OTHER||Miettinen and Nurminen|14.9|||||TWO_SIDED|95.0|5.0|24.9||||||||24.9|5.0|
91566581|NCT03840148|183022020|OTHER||Miettinen and Nurminen|12.7|||||TWO_SIDED|95.0|3.7|22.3||||||||22.3|3.7|
91566582|NCT03840148|183022021|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
91566583|NCT03840148|183022022|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.9|17.7||||||||17.7|-1.9|
91566584|NCT03840148|183022027|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
91566585|NCT03840148|183022029|OTHER||Miettinen and Nurminen|1.7|||||TWO_SIDED|95.0|-3.1|7.3||||||||7.3|-3.1|
91566586|NCT03840148|183022030|OTHER||Miettinen and Nurminen|4.8|||||TWO_SIDED|95.0|-1.1|11.5||||||||11.5|-1.1|
91566587|NCT03840148|183022031|OTHER||Miettinen and Nurminen|8.2|||||TWO_SIDED|95.0|1.2|15.7||||||||15.7|1.2|
91566588|NCT00257556|183022052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||||95.0|-0.17|0.26|||||A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation|||0.260|-0.170|
91566589|NCT04839289|183022080|OTHER||||||>|0.05||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||>0.05
91566590|NCT04839289|183022080|OTHER||||||<|0.0167||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.0167
91566591|NCT04839289|183022083|OTHER||||||<|0.01666667||||||When p-value is adjusted for multiple comparisons, the value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
91566592|NCT04839289|183022083|OTHER||||||<|0.01666667||||||When adjusted for multiple comparisons, the p-value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
91566593|NCT01350388|183022098|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
91566594|NCT01350388|183022099|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANCOVA|||||||0.73
91566595|NCT01350388|183022100|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||||||0.23
91566596|NCT01350388|183022101|SUPERIORITY_OR_OTHER|||||||0.88|||||||ANCOVA|||||||0.88
91566597|NCT01350388|183022102|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
91566598|NCT01350388|183022103|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
91566599|NCT00580047|183022105|OTHER||||||||||||||||||The intervention groups were compared for compliance to either having annual IV zoledronic acid, taking weekly oral alendronate, and taking calcium/vitamin D supplementation.|||
91566600|NCT02820298|183022106|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|131.41|||||TWO_SIDED|90.0|117.03|147.56|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||147.56|117.03|
91566601|NCT02820298|183022108|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|110.29|||||TWO_SIDED|90.0|103.91|117.06|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||117.06|103.91|
91566602|NCT02820298|183022109|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|108.34|||||TWO_SIDED|90.0|102.48|114.54|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||114.54|102.48|
91566603|NCT01780584|183022111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|1.0|3.0||Repeated Anova was used to determine whether there was difference of FT3 levels between groups|ANOVA|||Null hypothesis: no difference of free T3 (FT3) levels will be found between placebo, low dose and high dose group. We anticipated a difference of 2 pg/ml in FT3 with a standard deviation of 0.8 pg/ml between groups. For a statistical power of 80% to identify a treatment effect and at a level significance of 0.05 (2-sided).||3|1|<0.05
91566604|NCT01780584|183022113|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0||||0.31||95.0|3.0|10.0||Kruskal Wallis test was used to determine any difference of time of extubation between groups.|Kruskal-Wallis|||Null hypothesis: no difference of time to extubation between group. Statistical power 80% and level of significance 0.05||10|3|0.31
91566605|NCT01780584|183022114|SUPERIORITY_OR_OTHER||Median Difference (Net)|50.0||||0.4||95.0|40.0|60.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of length of stay in Intensive Care Unit. Statistical power 80% and level of significance 0.05.||60|40|0.4
91566606|NCT01780584|183022115|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.06||95.0|5.0|15.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of postoperative hospital length of stay between groups. Statistical power 80% and level of significance 0.05.||15|5|0.06
91566607|NCT02825849|183022117|SUPERIORITY|||||||0.824|||||||Chi-squared|||||||.824
91566608|NCT00546884|183022118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.16|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
91566609|NCT02273180|183022131|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure:if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested, demonstrated if lower bound of 2-sided 95%CI of difference between SAR342434 \& Humalog was \>-0.3%.|Least Square (LS) Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.084|0.197|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.197|-0.084|
91566610|NCT01878383|183022169|OTHER|Sensitivity is the percent of non-pregnant women positive for shedding HSV by culture method in which GeneXpert test results is positive. Units equals percent non-pregnant women positive.|Sensitivity|100.0|||||TWO_SIDED|95.0|90.8|100.0|||||95% Clopper-Pearson Exact Confidence Interval|||100|90.8|
91566611|NCT01878383|183022170|OTHER|Positive percent agreement is the percent of pregnant women with positive routine PCR results in which GeneXpert test results is positive. Units equal percent of pregnant women positive.|Positive percent agreement|80.0|||||TWO_SIDED|95.0|73.7|86.3|||||95% large sample confidence interval|||86.3|73.7|
91566612|NCT01878383|183022171|OTHER|Negative percent agreement is the percent of pregnant women with negative routine PCR results in which GeneXpert test results is negative. Units equal percent of pregnant women negative.|Negative percent agreement|99.2|||||TWO_SIDED|95.0|99.0|99.5|||||95% large sample confidence interval|||99.5|99|
91566613|NCT03449134|183022180|OTHER||Estimated Percent Change Difference|-18.45||||0.041|TWO_SIDED|95.0|-32.92|-0.86||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||-0.86|-32.92|0.041
91566614|NCT03449134|183022180|OTHER||Estimated Percent Change Difference|1.56||||0.874|TWO_SIDED|95.0|-16.13|22.99||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||22.99|-16.13|0.874
91566615|NCT03449134|183022183|OTHER||Estimated Percent Change Difference|-17.68||||0.056|TWO_SIDED|95.0|-32.57|0.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||0.50|-32.57|0.056
91566616|NCT03449134|183022183|OTHER||Estimated Percent Change Difference|2.95||||0.77|TWO_SIDED|95.0|-15.33|25.19||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||25.19|-15.33|0.770
91566617|NCT03449134|183022184|OTHER||Odds Ratio (OR)|1.2||||0.416|TWO_SIDED|95.0|0.77|1.86|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.86|0.77|0.416
91566618|NCT03449134|183022184|OTHER||Odds Ratio (OR)|1.01||||0.948|TWO_SIDED|95.0|0.66|1.55|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.55|0.66|0.948
91566619|NCT03449134|183022185|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.94|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.05|0.94|
91566620|NCT03449134|183022185|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.01|2.18||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.18|1.01|
91566621|NCT03449134|183022186|OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.11|2.54||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.54|1.11|
91566622|NCT03449134|183022186|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.01|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.01|
91566623|NCT03449134|183022187|OTHER||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.03|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.03|
91566624|NCT03449134|183022187|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.89||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.89|0.86|
91566625|NCT03449134|183022188|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.85|1.98||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.98|0.85|
91566626|NCT03449134|183022188|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.92|2.12||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.12|0.92|
91566627|NCT00835510|183022189|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Fisher Exact|two-sided||||||0.0127
91566628|NCT00835510|183022189|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|two-sided||||||<0.0001
91566629|NCT00835510|183022194|NON_INFERIORITY_OR_EQUIVALENCE|The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.|Cure rate difference|-19.78||||||90.0|-30.27|-9.29||||||||-9.29|-30.27|
91566630|NCT01960348|183022201|SUPERIORITY||Least Squares Mean Difference|-33.99|STANDARD_ERROR_OF_MEAN|2.974|<|1e-07|TWO_SIDED|95.0|-39.86|-28.13||P=9.262E-24|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mNIS+7. The model includes baseline mNIS+7 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-28.13|-39.86|<0.0000001
91566631|NCT01960348|183022202|SUPERIORITY||Least Squares Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|3.1|<|1e-07|TWO_SIDED|95.0|-27.2|-15.0||P=1.103E-10|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in Norfolk QOL-DN total score. The model includes baseline Norfolk QOL-DN score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-15.0|-27.2|<0.0000001
91566632|NCT01960348|183022203|SUPERIORITY||Least Squares Mean Difference|-17.87|STANDARD_ERROR_OF_MEAN|2.254|<|1e-07|TWO_SIDED|95.0|-22.32|-13.43||P=1.404E-13|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in NIS-W. The model includes baseline NIS-W score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-13.43|-22.32|<0.0000001
91566633|NCT01960348|183022204|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.01|<|1e-07|TWO_SIDED|95.0|7.0|10.9||P=4.066E-16|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in R-ODS value. The model includes baseline R-ODS score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||10.9|7.0|<0.0000001
91566634|NCT01960348|183022205|SUPERIORITY||Least Squares Mean Difference|0.311|STANDARD_ERROR_OF_MEAN|0.0415|<|1e-07|TWO_SIDED|95.0|0.23|0.393||P=1.875E-12|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in 10-meter walk test result. The model includes baseline 10-meter walk test result as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||0.393|0.230|<0.0000001
91566635|NCT01960348|183022206|SUPERIORITY||Least Squares Mean Difference|115.7|STANDARD_ERROR_OF_MEAN|16.91|<|1e-07|TWO_SIDED|95.0|82.4|149.0||P=8.832E-11|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mBMI. The model includes baseline mBMI as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||149.0|82.4|<0.0000001
91566636|NCT01960348|183022207|SUPERIORITY||Least Squares Mean Difference|-7.53|STANDARD_ERROR_OF_MEAN|2.213||0.0008|TWO_SIDED|95.0|-11.89|-3.16|||Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in COMPASS-31 total score. The model includes baseline COMPASS-31 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-3.16|-11.89|0.0008
91566637|NCT02412111|183022231|SUPERIORITY||Least Square (LS) mean difference|0.3|||=|0.5846|TWO_SIDED|95.0|-0.8|1.4|||Mixed Model for Repeated Measures (MMRM)|||||1.4|-0.8|= 0.5846
91566638|NCT02412111|183022232|SUPERIORITY||Least square mean difference|0.8|||=|0.386|TWO_SIDED|95.0|-1.0|2.6|||Mixed models Repeated Measures (MMRM)|||||2.6|-1.0|= 0.3860
91566639|NCT02412111|183022233|SUPERIORITY||Least square mean difference|2.8|||=|0.1236|TWO_SIDED|95.0|-0.8|6.4|||Mixed models Repeated Measures (MMRM)|||||6.4|-0.8|= 0.1236
91566640|NCT02412111|183022234|SUPERIORITY||Least square mean difference|-5.8|||=|0.0216|TWO_SIDED|95.0|-10.7|-0.9|||Mixed models Repeated Measures (MMRM)|||||-0.9|-10.7|= 0.0216
91566641|NCT03935932|183022352|OTHER|||||||0.11|||||||Wilcoxon signed-rank|||||||0.11
91566642|NCT03935932|183022353|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91566643|NCT03935932|183022354|OTHER|||||||0.35|||||||Wilcoxon signed-rank|||||||0.35
91566644|NCT00352053|183022371|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.55
91566645|NCT00352053|183022372|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.40
91566646|NCT00352053|183022373|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.58
91566647|NCT00352053|183022374|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.37
91566648|NCT00352053|183022381|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.71
91566649|NCT00352053|183022382|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.47
91566650|NCT00352053|183022389|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.26
91566651|NCT00352053|183022390|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.63
91566652|NCT00352053|183022397|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
91566653|NCT00352053|183022398|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
91566654|NCT00352053|183022405|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||1.00
91566655|NCT00352053|183022406|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.38
91566656|NCT00352053|183022413|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||0.22
91566657|NCT00352053|183022414|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.48
91566658|NCT00352053|183022421|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||No adjustments for multiple comparisons were made.|Log Rank|No adjustments were made.||Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).||||0.29
91566659|NCT01490359|183022428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.008|TWO_SIDED|95.0|1.03|1.71||The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.|generalized estimating equations (GEE)||Estimate is odds ratio (intervention vs. health control).|Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.||1.71|1.03|.008
91566660|NCT04150341|183022436|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.881|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.881
91566661|NCT04150341|183022436|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.575|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||||0.1|-0.17|0.575
91566662|NCT00405912|183022510|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.51
91566663|NCT00405912|183022510|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.25
91566664|NCT00405912|183022511|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Fisher Exact|1 sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.52
91566665|NCT00405912|183022511|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.73
91566666|NCT03730662|183022512|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|97.5|-1.13|-0.86|||Mixed Models Analysis|||||-0.86|-1.13|<0.001
91566667|NCT03730662|183022512|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-1.14|||<|0.001|TWO_SIDED|97.5|-1.28|-1.0|||Mixed Models Analysis|||||-1.00|-1.28|<0.001
91566668|NCT03730662|183022513|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|97.5|-0.93|-0.66|||Mixed Models Analysis|||||-0.66|-0.93|<0.001
91566669|NCT03730662|183022514|SUPERIORITY||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-9.8|-8.3|||Mixed Models Analysis|||||-8.3|-9.8|<0.001
91566670|NCT03730662|183022514|SUPERIORITY||Mean Difference (Net)|-11.4|||<|0.001|TWO_SIDED|95.0|-12.1|-10.6|||Mixed Models Analysis|||||-10.6|-12.1|<0.001
91566671|NCT03730662|183022514|SUPERIORITY||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.3|-12.8|||Mixed Models Analysis|||||-12.8|-14.3|<0.001
91566672|NCT03730662|183022515|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.001|TWO_SIDED|95.0|3.47|6.58|||Regression, Logistic|||||6.58|3.47|<0.001
91566673|NCT03730662|183022515|SUPERIORITY||Odds Ratio (OR)|9.23|||<|0.001|TWO_SIDED|95.0|6.31|13.49|||Regression, Logistic|||||13.49|6.31|<0.001
91566674|NCT03730662|183022515|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|7.88|17.89|||Regression, Logistic|||||17.89|7.88|<0.001
91566675|NCT03730662|183022516|SUPERIORITY||Mean Difference (Net)|1.0||||0.672|TWO_SIDED|95.0|-3.7|5.7|||Mixed Models Analysis|||||5.7|-3.7|0.672
91566676|NCT03730662|183022516|SUPERIORITY||Mean Difference (Net)|-3.6||||0.134|TWO_SIDED|95.0|-8.2|1.1|||Mixed Models Analysis|||||1.1|-8.2|0.134
91566677|NCT03730662|183022516|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.001|TWO_SIDED|95.0|-12.6|-3.4|||Mixed Models Analysis|||||-3.4|-12.6|<0.001
91566678|NCT00833898|183022520|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.020
91566679|NCT00833898|183022521|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||0.15
91566680|NCT00833898|183022522|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Mixed Models Analysis|||||||0.029
91566681|NCT00833898|183022523|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
91566682|NCT00833898|183022524|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Mixed Models Analysis|||||||0.012
91566683|NCT00833898|183022525|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
91566684|NCT00833898|183022526|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
91566685|NCT00833898|183022527|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Mixed Models Analysis|||||||0.75
91566686|NCT00833898|183022528|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
91566687|NCT00833898|183022529|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
91566688|NCT00833898|183022530|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Mixed Models Analysis|||||||0.55
91566689|NCT00833898|183022531|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
91566690|NCT00833898|183022532|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
91566691|NCT00833898|183022533|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
91566692|NCT00833898|183022534|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
91566693|NCT00833898|183022535|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
91566694|NCT00833898|183022536|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.58
91566695|NCT00833898|183022536|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.33
91566696|NCT00833898|183022537|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
91566697|NCT00833898|183022538|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.18
91566698|NCT00833898|183022538|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||1.00
91566699|NCT00833898|183022539|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
91566700|NCT00833898|183022539|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
91566701|NCT00833898|183022540|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
91566702|NCT00833898|183022540|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
91566703|NCT03712449|183022558|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0009|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0009
91566704|NCT03712449|183022558|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
91566705|NCT03712449|183022559|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.7878|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.7878
91566706|NCT03712449|183022559|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0349|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0349
91566707|NCT03712449|183022560|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0043|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0043
91566708|NCT03712449|183022560|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
91566709|NCT03712449|183022561|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0017|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0017
91566710|NCT03712449|183022561|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
91566711|NCT03712449|183022562|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0105|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0105
91566712|NCT03712449|183022562|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
91566713|NCT03712449|183022563|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0004|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0004
91566714|NCT03712449|183022563|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<.0001
91566715|NCT03712449|183022568|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0005|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0005
91566716|NCT03712449|183022568|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
91566717|NCT01960114|183022590|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|25.241|STANDARD_ERROR_OF_MEAN|2.8344|<|0.001|TWO_SIDED|95.0|19.669|30.813||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||30.813|19.669|<0.001
91566718|NCT01960114|183022591|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91566719|NCT01960114|183022592|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
91566720|NCT01960114|183022593|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.||||<0.001
91566721|NCT01960114|183022594|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
91566722|NCT00225277|183022603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.886||||0.002||95.0|-1.448|-0.325|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way analysis of covariance (ANCOVA), treatment and center effects with baseline value as covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||-0.3250|-1.4480|0.002
91566723|NCT00225277|183022604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.048||||0.064||95.0|-8.3336|0.2374|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way ANCOVA, treatment and center effects with baseline value as covariate. LS mean of the treatment difference reported.||0.2374|-8.3336|0.064
91566724|NCT00225277|183022605|SUPERIORITY_OR_OTHER|||||||0.744||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.744
91566725|NCT00225277|183022606|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.883
91566726|NCT00225277|183022607|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.663
91566727|NCT01340300|183022629|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||<0.0001
91566728|NCT01340300|183022629|SUPERIORITY|||||||0.003||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.003
91566729|NCT01340300|183022629|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.01
91566730|NCT01340300|183022629|SUPERIORITY|||||||0.03||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.||||0.03
91566731|NCT01340300|183022630|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.||||0.0002
91566732|NCT01340300|183022630|SUPERIORITY|||||||0.002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.002
91566733|NCT01340300|183022630|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.02
91566734|NCT01340300|183022630|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.0002
91566735|NCT01340300|183022630|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.02
91566736|NCT01340300|183022631|SUPERIORITY|||||||0.0004||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.0004
91566737|NCT01340300|183022631|SUPERIORITY|||||||0.007||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.007
91566738|NCT01340300|183022632|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
91566739|NCT01340300|183022632|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
91566740|NCT01340300|183022632|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||0.01
91566741|NCT01340300|183022633|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
91566742|NCT01340300|183022633|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
91566743|NCT01340300|183022633|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||0.02
91566744|NCT01340300|183022634|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.||||0.01
91566745|NCT04098497|183022641|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.74, df = 28||baseline to day 42 comparison||||0.09
91566746|NCT04098497|183022642|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.75, df = 28||baseline to day 42||||0.09
91566747|NCT04098497|183022643|SUPERIORITY|||||||0.13|||||||Regression, Linear|β = 0.14, z = 1.51||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.13
91566748|NCT04098497|183022644|SUPERIORITY|||||||0.007|||||||Regression, Linear|β = 0.38, z = 2.71||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.007
91566749|NCT04098497|183022645|SUPERIORITY|||||||0.57|||||||Regression, Linear|β = 0.03, z = 0.58||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.57
91566750|NCT04098497|183022646|SUPERIORITY|||||||0.25|||||||Regression, Linear|β = 0.06, z = 1.15||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.25
91566751|NCT03455218|183022647|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
91566752|NCT03455218|183022649|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
91566753|NCT03455218|183022650|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
91566754|NCT03455218|183022651|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
91566755|NCT03455218|183022652|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91566756|NCT03455218|183022653|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
91566757|NCT03455218|183022654|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
91566758|NCT03455218|183022656|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
91566759|NCT03455218|183022657|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
91566760|NCT03455218|183022658|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
91566761|NCT03455218|183022659|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
91566762|NCT03455218|183022660|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
91566763|NCT03455218|183022661|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
91566764|NCT03455218|183022662|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
91566765|NCT03569475|183022670|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.41||0.2215|TWO_SIDED|95.0|-4.49|1.04|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||1.04|-4.49|0.2215
91566766|NCT03569475|183022670|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.41||0.1964|TWO_SIDED|95.0|-4.59|0.95|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.95|-4.59|0.1964
91566767|NCT03569475|183022671|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.6789|TWO_SIDED|95.0|-0.32|0.21|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.21|-0.32|0.6789
91566768|NCT03569475|183022671|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1126|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures|||||0.05|-0.48|0.1126
91566769|NCT02630706|183022672|SUPERIORITY|Constrained longitudinal data analysis (cLDA)|Difference in the LSM vs. placebo|-0.69|||<|0.001|TWO_SIDED|95.0|-0.85|-0.52||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|Least squares means = LSM||The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo.||-0.52|-0.85|<0.001
91566770|NCT02630706|183022672|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.8|||<|0.001|TWO_SIDED|95.0|-0.97|-0.63|||cLDA|||The primary hypothesis of the study was the mean change from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo.||-0.63|-0.97|<0.001
91566771|NCT02630706|183022673|SUPERIORITY||Difference in the LSM vs. placebo|-0.68|||<|0.001|TWO_SIDED|95.0|-0.86|-0.5||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|||||-0.50|-0.86|<0.001
91566772|NCT02630706|183022673|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|||||-0.58|-0.95|<0.001
91566773|NCT02630706|183022674|OTHER||Difference in % vs. Placebo|-6.0|||||TWO_SIDED|95.0|-16.5|4.6|||||||Miettinen-Nurminen method|4.6|-16.5|
91566774|NCT02630706|183022674|OTHER||Difference in % vs. Placebo|-2.8|||||TWO_SIDED|95.0|-13.3|7.7|||||||Miettinen-Nurminen method|7.7|-13.3|
91566775|NCT02630706|183022675|OTHER||Difference in % vs. Placebo|-8.9|||||TWO_SIDED|95.0|-20.5|3.0|||||||Miettinen-Nurminen method|3.0|-20.5|
91566776|NCT02630706|183022675|OTHER||Difference in % vs. Placebo|-4.8|||||TWO_SIDED|95.0|-16.5|6.9|||||||Miettinen-Nurminen method|6.9|-16.5|
91566777|NCT02630706|183022678|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-27.78|||<|0.001|TWO_SIDED|95.0|-33.85|-21.7|||cLDA|||||-21.70|-33.85|<0.001
91566778|NCT02630706|183022678|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-30.4|||<|0.001|TWO_SIDED|95.0|-36.45|-24.35|||cLDA|||||-24.35|-36.45|<0.001
91566779|NCT02630706|183022679|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-26.21|||<|0.001|TWO_SIDED|95.0|-32.41|-20.01|||cLDA|||||-20.01|-32.41|<0.001
91566780|NCT02630706|183022679|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-28.55|||<|0.001|TWO_SIDED|95.0|-34.67|-22.43|||cLDA|||||-22.43|-34.67|<0.001
91566781|NCT02630706|183022680|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.0|||<|0.001|TWO_SIDED|95.0|-2.51|-1.5|||cLDA|||||-1.50|-2.51|<0.001
91566782|NCT02630706|183022680|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.78|||<|0.001|TWO_SIDED|95.0|-2.28|-1.28|||cLDA|||||-1.28|-2.28|<0.001
91566783|NCT02630706|183022681|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.05|||<|0.001|TWO_SIDED|95.0|-2.63|-1.21|||cLDA|||||-1.21|-2.63|<0.001
91566784|NCT02630706|183022681|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.79|||<|0.001|TWO_SIDED|95.0|-2.36|-1.21|||cLDA|||||-1.21|-2.36|<0.001
91566785|NCT02630706|183022682|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.56|||<|0.001|TWO_SIDED|95.0|2.49|8.35|||Logistic regression model|||||8.35|2.49|<0.001
91566786|NCT02630706|183022682|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.59|||<|0.001|TWO_SIDED|95.0|2.52|8.36|||Logistic regression model|||||8.36|2.52|<0.001
91566787|NCT02630706|183022683|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.49|||<|0.001|TWO_SIDED|95.0|2.32|8.68|||Logistic regression model|||||8.68|2.32|<0.001
91566788|NCT02630706|183022683|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|3.47|||<|0.001|TWO_SIDED|95.0|1.77|6.8|||Logistic regression model|||||6.80|1.77|<0.001
91566789|NCT02630706|183022684|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.09|||<|0.001|TWO_SIDED|95.0|-6.48|-1.69|||cLDA|||||-1.69|-6.48|<0.001
91566790|NCT02630706|183022684|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-5.3|||<|0.001|TWO_SIDED|95.0|-7.68|-2.92|||cLDA|||||-2.92|-7.68|<0.001
91566791|NCT02630706|183022685|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-2.64||||0.058|TWO_SIDED|95.0|-5.36|0.09|||cLDA|||||0.09|-5.36|0.058
91566792|NCT02630706|183022685|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.08||||0.003|TWO_SIDED|95.0|-6.78|-1.39|||cLDA|||||-1.39|-6.78|0.003
91566793|NCT02630706|183022686|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.4||||0.086|TWO_SIDED|95.0|-3.0|0.2|||cLDA|||||0.20|-3.00|0.086
91566794|NCT02630706|183022686|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.42||||0.081|TWO_SIDED|95.0|-3.01|0.17|||cLDA|||||0.17|-3.01|0.081
91566795|NCT02630706|183022687|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-0.95||||0.315|TWO_SIDED|95.0|-2.8|0.9|||cLDA|||||0.90|-2.80|0.315
91566796|NCT02630706|183022687|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.0||||0.282|TWO_SIDED|95.0|-2.83|0.83|||cLDA|||||0.83|-2.83|0.282
91566797|NCT02630706|183022688|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.9||||0.001|TWO_SIDED|95.0|2.46|32.22||Nominal p-values were provided.|Logistic regression model|||||32.22|2.46|0.001
91566798|NCT02630706|183022688|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|10.69|||<|0.001|TWO_SIDED|95.0|2.95|38.71||Nominal p-values were provided.|Logistic regression model|||||38.71|2.95|<0.001
91566799|NCT02630706|183022689|SUPERIORITY|Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.34|||<|0.001|TWO_SIDED|95.0|2.52|27.6||Nominal p-values were provided.|Logistic regression model|||||27.60|2.52|<0.001
91566800|NCT02630706|183022689|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.29|||<|0.001|TWO_SIDED|95.0|2.44|28.11||Nominal p-values were provided.|Logistic regression model|||||28.11|2.44|<0.001
91566801|NCT02630706|183022690|OTHER||Difference in % (Ert. 15 mg. - placebo)|-9.0|||<|0.001||95.0|-14.5|-5.0|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-5.0|-14.5|<0.001
91566802|NCT02630706|183022690|OTHER||Difference in % (Ert. 5 mg. - placebo)|-8.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.4|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-4.4|-14.0|<0.001
91566803|NCT02630706|183022691|OTHER||Difference in % (Ert. 15 mg. - placebo)|-8.9||||0.001||95.0|-15.1|-4.2|||Miettinen & Nurminen method|||||-4.2|-15.1|0.001
91566804|NCT02630706|183022691|OTHER||Difference in % (Ert. 5 mg. - placebo)|-9.6|||<|0.001|TWO_SIDED|95.0|-15.8|-5.7|||Miettinen & Nurminen method|||||-5.7|-15.8|<0.001
91566805|NCT00702273|183022708|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -8%|Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.6|7.4||||||Treatment groups were compared with a generalized linear model including covariates treatment group, age class and region.||7.4|-2.6|
91566806|NCT01894256|183022717|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.15|||||TWO_SIDED|90.0|1.04|1.27|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.27|1.04|
91566807|NCT01894256|183022717|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.26|||||TWO_SIDED|90.0|1.06|1.48|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.48|1.06|
91566808|NCT01894256|183022718|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.24|||||TWO_SIDED|90.0|1.06|1.47|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.47|1.06|
91566809|NCT01894256|183022718|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.44|||||TWO_SIDED|90.0|1.1|1.89|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.89|1.10|
91566810|NCT00645099|183022734|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||Based on available data it was estimated that in the paliperidone ER group the TG:HDL ratio would decrease with 0.15 and that the TG:HDL ratio would increase with 0.25 in the olanzapine group. The common SD of the change was estimated to be 1.4. A sample size of 205 patients in each treatment arm had 80% power to detect a difference of 0.4 in change of TG:HDL ratio after 6 months of treatment in favor of paliperidone ER treatment (Wilcoxon two-sample test with 0.05 two-sided significance level).||||< 0.0001
91566811|NCT00645099|183022734|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group comparison of the change from baseline at end point.||||0.4718
91566812|NCT00645099|183022734|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline at end point.||||< 0.0001
91566813|NCT00645099|183022735|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
91566814|NCT00645099|183022735|SUPERIORITY_OR_OTHER|||||||0.9143||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.9143
91566815|NCT00645099|183022735|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
91566816|NCT00645099|183022736|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0050
91566817|NCT00645099|183022736|SUPERIORITY_OR_OTHER|||||||0.4454||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.4454
91566818|NCT00645099|183022736|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0018
91566819|NCT00645099|183022737|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
91566820|NCT00645099|183022738|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0004
91566821|NCT00645099|183022739|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0272
91566822|NCT00645099|183022740|SUPERIORITY_OR_OTHER|||||||0.1892||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1892
91566823|NCT00645099|183022741|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0325
91566824|NCT00645099|183022742|SUPERIORITY_OR_OTHER|||||||0.1117||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1117
91566825|NCT00645099|183022743|SUPERIORITY_OR_OTHER|||||||0.6346||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6346
91566826|NCT00645099|183022744|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||1.0000
91566827|NCT00645099|183022745|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6770
91566828|NCT00645099|183022746|SUPERIORITY_OR_OTHER|||||||0.1308||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1308
91566829|NCT00645099|183022747|SUPERIORITY_OR_OTHER|||||||0.3358||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.3358
91566830|NCT00645099|183022748|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
91566831|NCT00645099|183022748|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0001
91566832|NCT00645099|183022748|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||< 0.0001
91566833|NCT00645099|183022749|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
91566834|NCT00645099|183022750|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
91566835|NCT00645099|183022751|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.0230
91566836|NCT00645099|183022752|NON_INFERIORITY_OR_EQUIVALENCE|Testing non-inferiority of the paliperidone ER treatment group compared to the olanzapine treatment group, with regard to change versus baseline at end point of the total PANSS was done by means of Schuirmann's test. A difference of 6 points in change versus baseline on the total PANSS was considered to be a minimum clinically relevant difference.The null hypothesis is that there is no difference between paliperidone and olanzapine in change in TG:HDL ratio from baseline to endpoint.||||||0.0242||95.0|||||Schuirmann|The null hypothesis of non-equivalence was rejected and equivalence to within the specified equivalence bounds could be claimed.||||||0.0242
91566837|NCT00645099|183022752|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
91566838|NCT00645099|183022752|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
91566839|NCT01201915|183022753|SUPERIORITY_OR_OTHER|||||||0.8463|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.8463
91566840|NCT01201915|183022753|SUPERIORITY_OR_OTHER|||||||0.9668|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.||||0.9668
91566841|NCT01201915|183022753|SUPERIORITY_OR_OTHER|||||||0.7878|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.7878
91566842|NCT00663923|183022778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.1|<|0.05|TWO_SIDED|95.0|-0.62|-0.001||two - tailed p value \<0.05 were considered statistically significant.|t-test, 2 sided|in this study degrees of freedom is sample size - 1||||-.001|-.62|<0.05
91566843|NCT03859622|183022787|OTHER|Frequencies and percentages for categorical data.||||||||||||Standard methods are used for the description of data (frequencies and percentages for categorical data)||||Standard methods are used for the description of data (frequencies and percentages for categorical data)|Standard methods are used for the description of data (frequencies and percentages for categorical data)|||
91566844|NCT00092521|183022822|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|95.1|100.0|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||100|95.1|
91566845|NCT00092521|183022823|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|94.9|100.0|||||CI based on binomial tail probabilities and not from a dispersion parameter|||100|94.9|
91566846|NCT00113269|183022848|SUPERIORITY_OR_OTHER||differences in event rates|-3.3||||0.4889|TWO_SIDED|95.305|-12.7|6.1|||Normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||6.1|-12.7|0.4889
91566847|NCT00113269|183022848|SUPERIORITY_OR_OTHER||differences in event rates|-15.7|||<|0.0001|TWO_SIDED|95.305|-21.9|-9.4|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||-9.4|-21.9|<0.0001
91566848|NCT00113269|183022849|SUPERIORITY_OR_OTHER||differences in event rates|2.7||||0.6533|TWO_SIDED|95.0|-9.0|14.3|||normal approximation|||||14.3|-9.0|0.6533
91566849|NCT00113269|183022849|SUPERIORITY_OR_OTHER||differences in event rates|-11.9||||0.0024|TWO_SIDED|95.0|-19.5|-4.2|||normal approximation|||||-4.2|-19.5|0.0024
91566850|NCT00113269|183022850|SUPERIORITY_OR_OTHER||differences in event rates|-6.1||||0.4087|TWO_SIDED|95.0|-20.7|8.4|||normal approximation|||||8.4|-20.7|0.4087
91566851|NCT00113269|183022850|SUPERIORITY_OR_OTHER||differences in event rates|-8.7||||0.0456|TWO_SIDED|95.0|-17.2|-0.2|||normal approximation|||||-0.2|-17.2|0.0456
91566852|NCT00113269|183022851|SUPERIORITY_OR_OTHER||differences in event rates|1.1||||0.8742|TWO_SIDED|95.0|-12.7|15.0|||normal approximation|||||15.0|-12.7|0.8742
91566853|NCT00113269|183022851|SUPERIORITY_OR_OTHER||differences in event rates|-14.1||||0.001|TWO_SIDED|95.0|-22.5|-5.7|||normal approximation|||||-5.7|-22.5|0.0010
91566854|NCT00113269|183022853|SUPERIORITY_OR_OTHER||differences in event rates|3.5||||0.4134|TWO_SIDED|95.0|-4.8|11.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||11.7|-4.8|0.4134
91566855|NCT00113269|183022853|SUPERIORITY_OR_OTHER||differences in event rates|2.4||||0.2459|TWO_SIDED|95.0|-1.7|6.5|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.5|-1.7|0.2459
91566856|NCT00113269|183022854|SUPERIORITY_OR_OTHER||differences in event rates|6.0||||0.3155|TWO_SIDED|95.0|-5.7|17.6|||normal approximation|||||17.6|-5.7|0.3155
91566857|NCT00113269|183022854|SUPERIORITY_OR_OTHER||differences in event rates|-0.4||||0.9045|TWO_SIDED|95.0|-6.5|5.7|||normal approximation|||||5.7|-6.5|0.9045
91566858|NCT00113269|183022855|SUPERIORITY_OR_OTHER||differences in event rates|1.6||||0.5265|TWO_SIDED|95.0|-3.4|6.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.7|-3.4|0.5265
91566859|NCT00113269|183022855|SUPERIORITY_OR_OTHER||differences in event rates|-0.6||||0.682|TWO_SIDED|95.0|-3.4|2.2|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||2.2|-3.4|0.6820
91566860|NCT00113269|183022856|SUPERIORITY_OR_OTHER||differences in event rates|5.9||||0.1797|TWO_SIDED|95.0|-2.7|14.4|||normal approximation|||||14.4|-2.7|0.1797
91566861|NCT00113269|183022856|SUPERIORITY_OR_OTHER||differences in event rates|-1.4||||0.5655|TWO_SIDED|95.0|-6.3|3.4|||normal approximation|||||3.4|-6.3|0.5655
91566862|NCT00113269|183022857|SUPERIORITY_OR_OTHER|||||||0.4735||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.4735
91566863|NCT00113269|183022857|SUPERIORITY_OR_OTHER|||||||0.1186||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1186
91566864|NCT00113269|183022858|SUPERIORITY_OR_OTHER|||||||0.5231||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.5231
91566865|NCT00113269|183022858|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1220
91566866|NCT01580995|183022910|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
91566867|NCT01268098|183022939|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|5.0|||>|0.999|TWO_SIDED|95.0|-20.6|30.7||All hypothesis testings in this study were based on type I error of 0.05. Adjustment for multiplicity was not applied.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between the two dose arms.|The 2-sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis corresponding to the primary efficacy endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms. This sample size for this study was not based on the statistical considerations.||30.7|-20.6|>0.999
91566868|NCT01268098|183022940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258|TWO_SIDED||||||Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference betweenthe two dose arms.||The null hypothesis corresponding to this endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms.||||0.258
91566869|NCT02416713|183022943|SUPERIORITY||relative change from baseline|0.66||||0.12|TWO_SIDED|95.0|-0.18|1.51|||Mixed Models Analysis|||||1.51|-0.18|0.12
91566870|NCT02416713|183022943|SUPERIORITY||relative change from baseline|-0.3||||0.49|TWO_SIDED|95.0|-1.17|0.57|||Mixed Models Analysis|||||0.57|-1.17|0.49
91566871|NCT02416713|183022943|SUPERIORITY||Slope|-0.16||||0.7|TWO_SIDED|95.0|-1.0|0.69|||Mixed Models Analysis|||||0.69|-1.00|0.70
91566872|NCT01644188|183022964|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-34.4|-25.3||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-25.3|-34.4|<0.0001
91566873|NCT01644188|183022965|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.6|||<|0.0001|TWO_SIDED|95.0|-34.9|-26.2||Threshold for significance ≤0.05|Mixed Models Analysis||Alirocumab vs. ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.2|-34.9|<0.0001
91566874|NCT01644188|183022966|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.4|||<|0.0001|TWO_SIDED|95.0|-33.7|-25.1||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.1|-33.7|<0.0001
91566875|NCT01644188|183022967|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.7|||<|0.0001|TWO_SIDED|95.0|-33.8|-25.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.6|-33.8|<0.0001
91566876|NCT01644188|183022968|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-26.0|-18.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.8|-26|<0.0001
91566877|NCT01644188|183022969|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-26.5|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-26.5|<0.0001
91566878|NCT01644188|183022970|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-26.9|-18.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.9|-26.9|<0.0001
91566879|NCT01644188|183022971|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.5|||<|0.0001|TWO_SIDED|95.0|-27.2|-19.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.7|-27.2|<0.0001
91566880|NCT01644188|183022972|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.7|||<|0.0001|TWO_SIDED|95.0|-17.7|-11.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.7|-17.7|<0.0001
91566881|NCT01644188|183022973|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|95.0|-25.7|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-25.7|<0.0001
91566882|NCT01644188|183022974|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-25.6|-18.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.3|-25.6|<0.0001
91566883|NCT01644188|183022975|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|||<|0.0001|TWO_SIDED|95.0|-17.1|-11.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.6|-17.1|<0.0001
91566884|NCT01644188|183022976|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|||<|0.0001|TWO_SIDED|95.0|-36.3|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.1|-36.3|<0.0001
91566885|NCT01644188|183022977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.7|7.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by Logistic regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|3.7|<0.0001
91566886|NCT01644188|183022978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.8|3.9|<0.0001
91566887|NCT01644188|183022979|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.7|||<|0.0001|TWO_SIDED|95.0|-26.4|-17.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17|-26.4|<0.0001
91566888|NCT01644188|183022980|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|5.4|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.7|5.4|<0.0001
91566889|NCT01644188|183022981|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3||||0.9117|TWO_SIDED|95.0|-5.1|4.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.6|-5.1|0.9117
91566890|NCT04333732|183022994|SUPERIORITY||Risk Difference (RD)|0.3||||0.52|TWO_SIDED|95.0|-0.5|1.1|||Regression, Logistic|||The primary endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.1|-0.5|0.52
91566891|NCT04333732|183022995|SUPERIORITY||Risk Difference (RD)|0.04||||0.95|TWO_SIDED|95.0|-1.4|1.3|||Regression, Logistic|difference, 0·04%, 95% CI, -1·4% to 1·3%, p=0·95).||The endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.3|-1.4|0.95
91566892|NCT01699698|183023010|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91566893|NCT00004146|183023030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.65|1.12|||t-test, 1 sided|||the study design is to detect 30% reduction in hazard of deaths with 78% power at one side alpha level of 0.10. Overall survial time was calculated from time of histological diagnosis until time of death from any event.||1.12|0.65|0.10
91566894|NCT00526097|183023033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|2.6|4.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.0|2.6|<0.0001
91566895|NCT00526097|183023034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|3.5|5.2||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.2|3.5|<0.0001
91566896|NCT00526097|183023035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.7|4.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.3|2.7|<0.0001
91566897|NCT00526097|183023036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001||95.0|2.0|3.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.6|2.0|<0.0001
91566898|NCT00526097|183023037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|1.8|3.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.4|1.8|<0.0001
91566899|NCT00526097|183023038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|4.1|5.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.8|4.1|<0.0001
91566900|NCT00526097|183023039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001||95.0|5.8|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|5.8|<0.0001
91566901|NCT00526097|183023040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001||95.0|3.8|5.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.6|3.8|<0.0001
91566902|NCT00526097|183023041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001||95.0|2.9|4.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.7|2.9|<0.0001
91566903|NCT00526097|183023042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.9|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|2.9|<0.0001
91566904|NCT00526097|183023043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.||||<0.0001
91566905|NCT00526097|183023044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001||95.0|1.62|2.57|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.57|1.62|<0.0001
91566906|NCT00526097|183023045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|||<|0.0001||95.0|1.44|2.13|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.13|1.44|<0.0001
91566907|NCT00526097|183023046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.0001||95.0|1.62|2.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.66|1.62|<0.0001
91566908|NCT00526097|183023047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.0001||95.0|1.37|2.11|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.11|1.37|<0.0001
91566909|NCT00526097|183023048|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|||<|0.0001||95.0|1.24|1.88|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||1.88|1.24|<0.0001
91566910|NCT00526097|183023049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.13|||<|0.0001||95.0|4.28|68.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||68.66|4.28|<0.0001
91566911|NCT00526097|183023050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.0001||95.0|1.81|3.35|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.35|1.81|<0.0001
91566912|NCT00526097|183023051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.0025||95.0|1.32|4.74|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||4.74|1.32|0.0025
91566913|NCT00526097|183023052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.08||||0.0105||95.0|1.26|13.24|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||13.24|1.26|0.0105
91566914|NCT00526097|183023053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4002||95.0|0.52|6.47|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||6.47|0.52|0.4002
91566915|NCT00526097|183023054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||1||95.0|0.37|3.77|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.77|0.37|1.0000
91566916|NCT00526097|183023055|SUPERIORITY_OR_OTHER|||||||0.0951|||||||Fisher Exact|||||||0.0951
91566917|NCT00526097|183023056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.09|0.41|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.41|0.09|<0.0001
91566918|NCT00526097|183023057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.2524||95.0|0.02|2.67|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.67|0.02|0.2524
91566919|NCT00526097|183023058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.0035||95.0|0.06|0.63|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.63|0.06|0.0035
91566920|NCT00526097|183023059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06||||0.0004||95.0|0.01|0.46|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.46|0.01|0.0004
91566921|NCT00526097|183023060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0086||95.0|0.1|0.69|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.69|0.10|0.0086
91566922|NCT00526097|183023061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-1.2|-0.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.9|-1.2|<0.0001
91566923|NCT00526097|183023062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.2|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.2|<0.0001
91566924|NCT00526097|183023063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.1|<0.0001
91566925|NCT00526097|183023064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
91566926|NCT00526097|183023065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.4|2.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.9|2.4|<0.0001
91566927|NCT00526097|183023066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.1|2.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.7|2.1|<0.0001
91566928|NCT00526097|183023067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|2.0|2.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.5|2.0|<0.0001
91566929|NCT00526097|183023068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|1.7|2.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.3|1.7|<0.0001
91566930|NCT00526097|183023069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0002||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0002
91566931|NCT00526097|183023070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0003||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0003
91566932|NCT00526097|183023071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0127||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0127
91566933|NCT00526097|183023072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0064||95.0|-0.3|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.3|0.0064
91566934|NCT00526097|183023073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.9|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-0.9|<0.0001
91566935|NCT00526097|183023074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-1.0|<0.0001
91566936|NCT00526097|183023075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
91566937|NCT00526097|183023076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
91566938|NCT00526097|183023077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
91566939|NCT00526097|183023078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|<0.0001
91566940|NCT00526097|183023079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
91566941|NCT00526097|183023080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0018
91566942|NCT00526097|183023081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566943|NCT00526097|183023082|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566944|NCT00526097|183023083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566945|NCT00526097|183023084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566946|NCT00526097|183023085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566947|NCT00526097|183023086|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566948|NCT00526097|183023087|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566949|NCT00526097|183023088|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566950|NCT00526097|183023089|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566951|NCT00526097|183023090|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566952|NCT00526097|183023091|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566953|NCT00526097|183023092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
91566954|NCT00526097|183023093|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.6773
91566955|NCT00526097|183023094|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0002
91566956|NCT00526097|183023095|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0001
91566957|NCT00526097|183023096|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0005
91566958|NCT00526097|183023097|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
91566959|NCT00526097|183023098|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
91566960|NCT00526097|183023099|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
91566961|NCT00526097|183023100|SUPERIORITY_OR_OTHER|||||||0.0058||||||Exact p-value|Wilcoxon rank sum test|||||||0.0058
91566962|NCT00526097|183023101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|2.01||0.798||95.0|-3.4|4.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.5|-3.4|0.7980
91566963|NCT00526097|183023102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|2.05||0.6129||95.0|-3.0|5.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.1|-3.0|0.6129
91566964|NCT00526097|183023103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.31||0.3567||95.0|-2.4|6.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.7|-2.4|0.3567
91566965|NCT00526097|183023104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|1.34||0.1407||95.0|-0.7|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|-0.7|0.1407
91566966|NCT00526097|183023105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|1.74||0.013||95.0|0.9|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|0.9|0.0130
91566967|NCT00526097|183023106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.14||0.5849||95.0|-3.0|5.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.3|-3.0|0.5849
91566968|NCT00526097|183023107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.7543||95.0|-3.2|4.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.4|-3.2|0.7543
91566969|NCT00526097|183023108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.58||0.0273||95.0|0.4|6.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.6|0.4|0.0273
91566970|NCT00526097|183023109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.87||0.129||95.0|-0.4|3.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.0|-0.4|0.1290
91566971|NCT00526097|183023110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.378||95.0|-0.8|2.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.0|-0.8|0.3780
91566972|NCT00526097|183023111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.6|-0.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.3|-0.6|<0.0001
91566973|NCT00526097|183023112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.7|-1.0|<0.0001
91566974|NCT00526097|183023113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0070
91566975|NCT00526097|183023114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.5|-1.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-1.0|-1.5|<0.0001
91566976|NCT00526097|183023115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
91566977|NCT03713281|183023153|SUPERIORITY||Least-square mean|-0.131|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.208|-0.054|||Linear Mixed Model|Kenward and Roger modethod for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.||-0.054|-0.208|
91566978|NCT03713281|183023154|SUPERIORITY||Least-square means|0.06|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.017|0.137|||Linear Mixed Model|Kenward and Roger method for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.||0.137|-0.017|
91566979|NCT05109117|183023169|SUPERIORITY||Adjusted Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||3.9|1.7|<0.0001
91566980|NCT05109117|183023169|SUPERIORITY||Adjusted Mean Difference|1.5||||0.0077|TWO_SIDED|95.0|0.4|2.7|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment||2.7|0.4|0.0077
91566981|NCT05109117|183023169|SUPERIORITY||Adjusted Mean Difference|1.8||||0.0019|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment||2.9|0.7|0.0019
91566982|NCT05109117|183023169|SUPERIORITY||Adjusted Mean Difference|1.0||||0.0707|TWO_SIDED|95.0|-0.1|2.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment||2.2|-0.1|0.0707
91566983|NCT03897049|183023171|SUPERIORITY||Odds Ratio (OR)|0.961||||0.914|TWO_SIDED|95.0|0.463|1.994|||Regression, Logistic|||||1.994|0.463|0.914
91566984|NCT03897049|183023172|SUPERIORITY||Odds Ratio (OR)|0.979||||0.99|TWO_SIDED|95.0|0.473|2.074|||Regression, Logistic|||||2.074|0.473|0.990
91566985|NCT03897049|183023173|SUPERIORITY||Odds Ratio (OR)|1.434||||0.167|TWO_SIDED|95.0|0.861|2.39|||Regression, Logistic|||||2.390|0.861|0.167
91566986|NCT03897049|183023174|SUPERIORITY||Odds Ratio (OR)|1.492||||0.118|TWO_SIDED|95.0|0.903|2.466|||Regression, Logistic|||||2.466|0.903|0.118
91566987|NCT03897049|183023175|SUPERIORITY||Odds Ratio (OR)|1.335||||0.265|TWO_SIDED|95.0|0.803|2.221|||Regression, Logistic|||||2.221|0.803|0.265
91566988|NCT03897049|183023176|SUPERIORITY||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.593|1.654|||Regression, Logistic|||||1.654|0.593|0.971
91566989|NCT03897049|183023177|SUPERIORITY||Mean Difference (Net)|-0.27||||0.942|TWO_SIDED||||||Regression, Linear|||||||0.942
91566990|NCT03897049|183023178|SUPERIORITY||Mean Difference (Net)|0.02||||0.741|TWO_SIDED||||||Regression, Linear|||||||0.741
91566991|NCT03897049|183023179|SUPERIORITY||Mean Difference (Net)|0.07||||0.494|TWO_SIDED||||||Regression, Linear|||||||0.494
91566992|NCT03897049|183023180|SUPERIORITY||Mean Difference (Net)|0.15||||0.651|TWO_SIDED||||||Regression, Linear|||||||0.651
91566993|NCT03897049|183023181|SUPERIORITY||Mean Difference (Net)|0.3||||0.022|TWO_SIDED||||||Regression, Linear|||||||0.022
91566994|NCT03897049|183023182|SUPERIORITY||Mean Difference (Net)|2.85||||0.189|TWO_SIDED||||||Regression, Linear|||||||0.189
91566995|NCT03897049|183023183|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.218|TWO_SIDED||||||Regression, Linear|||||||0.218
91566996|NCT03897049|183023184|SUPERIORITY||Odds Ratio (OR)|0.479||||0.149|TWO_SIDED|95.0|0.173|1.305|||Regression, Logistic|||||1.305|0.173|0.149
91566997|NCT03897049|183023185|SUPERIORITY||Odds Ratio (OR)|1.111||||0.839|TWO_SIDED|95.0|0.403|3.063|||Regression, Logistic|||||3.063|0.403|0.839
91566998|NCT03897049|183023186|SUPERIORITY||Odds Ratio (OR)|3.302||||0.063|TWO_SIDED|95.0|0.937|11.641|||Regression, Logistic|||||11.641|0.937|0.063
91566999|NCT03897049|183023187|SUPERIORITY||Mean Difference (Net)|-0.08||||0.65|TWO_SIDED||||||Regression, Linear|||||||0.650
91567000|NCT03897049|183023188|SUPERIORITY||Mean Difference (Net)|0.09||||0.531|TWO_SIDED||||||Regression, Linear|||||||0.531
91567001|NCT03897049|183023189|SUPERIORITY||Mean Difference (Net)|-0.03||||0.761|TWO_SIDED||||||Regression, Linear|||||||0.761
91567002|NCT03897049|183023190|SUPERIORITY||Mean Difference (Net)|0.11||||0.503|TWO_SIDED||||||Regression, Linear|||||||0.503
91567003|NCT03897049|183023191|SUPERIORITY||Mean Difference (Net)|0.01||||0.541|TWO_SIDED||||||Regression, Linear|||||||0.541
91567004|NCT03897049|183023192|SUPERIORITY||Mean Difference (Net)|-0.02||||0.537|TWO_SIDED||||||Regression, Linear|||||||0.537
91567005|NCT03897049|183023193|SUPERIORITY||Mean Difference (Net)|0.19||||0.057|TWO_SIDED||||||Regression, Linear|||||||0.057
91567006|NCT03897049|183023194|SUPERIORITY||Mean Difference (Net)|0.1||||0.402|TWO_SIDED||||||Regression, Linear|||||||0.402
91567007|NCT03897049|183023195|SUPERIORITY||Mean Difference (Net)|0.15||||0.308|TWO_SIDED||||||Regression, Linear|||||||0.308
91567008|NCT03897049|183023196|SUPERIORITY||Mean Difference (Net)|0.48||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
91567009|NCT02166047|183023201|SUPERIORITY||Least Squares (LS) Mean Difference|0.023||||0.59|TWO_SIDED|95.0|-0.061|0.108||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.108|-0.061|0.590
91567010|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.068||||0.12|TWO_SIDED|95.0|-0.018|0.154||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.154|-0.018|0.120
91567011|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.017||||0.701|TWO_SIDED|95.0|-0.069|0.102||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.102|-0.069|0.701
91567012|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.082||||0.21|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.210
91567013|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.082||||0.207|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.207
91567014|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.081||||0.216|TWO_SIDED|95.0|-0.048|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.048|0.216
91567015|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|-0.015||||0.652|TWO_SIDED|95.0|-0.081|0.051||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.051|-0.081|0.652
91567016|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.0||||0.994|TWO_SIDED|95.0|-0.066|0.065||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.065|-0.066|0.994
91567017|NCT02166047|183023201|SUPERIORITY||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.069|0.069||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.069|-0.069|0.996
91567018|NCT00451555|183023214|SUPERIORITY|||||||0.6238|||||||Fisher Exact|||||||0.6238
91567019|NCT00451555|183023214|SUPERIORITY|||||||0.6282|||||||Fisher Exact|||||||0.6282
91567020|NCT00451555|183023214|SUPERIORITY|||||||0.6242|||||||Fisher Exact|||||||0.6242
91567021|NCT00451555|183023215|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.6390
91567022|NCT00451555|183023215|SUPERIORITY|||||||0.6721|||||||Fisher Exact|||||||0.6721
91567023|NCT00451555|183023215|SUPERIORITY|||||||0.6349|||||||Fisher Exact|||||||0.6349
91567024|NCT00451555|183023216|SUPERIORITY|||||||0.8582|||||||Log Rank|||||||0.8582
91567025|NCT00451555|183023216|SUPERIORITY|||||||0.7307|||||||Log Rank|||||||0.7307
91567026|NCT00451555|183023216|SUPERIORITY|||||||0.9798|||||||Log Rank|||||||0.9798
91567027|NCT00451555|183023217|SUPERIORITY|||||||0.5887|||||||Log Rank|||||||0.5887
91567028|NCT00451555|183023217|SUPERIORITY|||||||0.4516|||||||Log Rank|||||||0.4516
91567029|NCT00451555|183023217|SUPERIORITY|||||||0.7965|||||||Log Rank|||||||0.7965
91567030|NCT01376050|183023222|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
91567031|NCT01376050|183023223|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
91567032|NCT00619983|183023230|SUPERIORITY|||||||0.69|||||||ANOVA|Repeated measures ANOVA||Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit \< 30% of the number of subjects required in our power analysis.||||0.69
91567033|NCT01177137|183023233|SUPERIORITY||Slope|-2.35|STANDARD_ERROR_OF_MEAN|3.27||0.47|TWO_SIDED|95.0|-8.77|4.07||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.07|-8.77|0.47
91567034|NCT01177137|183023233|SUPERIORITY||Slope|-2.8|STANDARD_ERROR_OF_MEAN|2.78||0.31|TWO_SIDED|95.0|-8.27|2.65||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.65|-8.27|0.31
91567035|NCT01177137|183023234|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|2.63||0.96|TWO_SIDED|95.0|-5.3|5.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.02|-5.30|0.96
91567036|NCT01177137|183023234|SUPERIORITY||Slope|2.74|STANDARD_ERROR_OF_MEAN|2.53||0.28|TWO_SIDED|95.0|-2.21|7.7||The a priori threshold for statistical significance was \<0.025 to adjust for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.70|-2.21|0.28
91567037|NCT01177137|183023235|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|-0.55|1.77||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.77|-0.55|0.30
91567038|NCT01177137|183023235|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
91567039|NCT01177137|183023237|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|1.37||0.77|TWO_SIDED|95.0|-3.08|2.29||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.29|-3.08|0.77
91567040|NCT01177137|183023237|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.65|TWO_SIDED|95.0|-3.16|1.96||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.96|-3.16|0.65
91567041|NCT01177137|183023238|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.52||0.5|TWO_SIDED|95.0|-1.38|0.67||The a priori threshold for statistical significance was set at \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.67|-1.38|0.50
91567042|NCT01177137|183023238|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.52||0.82|TWO_SIDED|95.0|-1.14|0.9||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.90|-1.14|0.82
91567043|NCT01177137|183023239|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.46|TWO_SIDED|95.0|-1.37|0.62||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation.|||0.62|-1.37|0.46
91567044|NCT01177137|183023239|SUPERIORITY|The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.51||0.48|TWO_SIDED|95.0|-1.35|0.64|||repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.64|-1.35|0.48
91567045|NCT01177137|183023240|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.75|TWO_SIDED|95.0|-0.74|0.53||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.53|-0.74|0.75
91567046|NCT01177137|183023240|SUPERIORITY||Slope|-0.87|STANDARD_ERROR_OF_MEAN|0.35||0.015|TWO_SIDED|95.0|-1.56|-0.17||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.17|-1.56|0.015
91567047|NCT01177137|183023241|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.83|0.69||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.69|-0.83|0.85
91567048|NCT01177137|183023241|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.55|TWO_SIDED|95.0|-0.86|0.46||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.46|-0.86|0.55
91567049|NCT01177137|183023242|SUPERIORITY||Slope|-3.19|STANDARD_ERROR_OF_MEAN|3.1||0.3|TWO_SIDED|95.0|-9.27|2.88||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.88|-9.27|0.30
91567050|NCT01177137|183023242|SUPERIORITY||Slope|-0.91|STANDARD_ERROR_OF_MEAN|2.98||0.76|TWO_SIDED|95.0|-6.75|4.93||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.93|-6.75|0.76
91567051|NCT01177137|183023243|SUPERIORITY||Slope|3.12|STANDARD_ERROR_OF_MEAN|3.34||0.35|TWO_SIDED|95.0|-3.44|9.68||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.68|-3.44|0.35
91567052|NCT01177137|183023243|SUPERIORITY||Slope|3.29|STANDARD_ERROR_OF_MEAN|3.19||0.3|TWO_SIDED|95.0|-2.96|9.54||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.54|-2.96|0.30
91567053|NCT01177137|183023244|SUPERIORITY||Slope|1.41|STANDARD_ERROR_OF_MEAN|3.37||0.68|TWO_SIDED|95.0|-5.2|8.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||8.02|-5.20|0.68
91567054|NCT01177137|183023244|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|3.26||0.77|TWO_SIDED|95.0|-5.44|7.33||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.33|-5.44|0.77
91567055|NCT01177137|183023245|SUPERIORITY||Slope|-3.53|STANDARD_ERROR_OF_MEAN|4.47||0.43|TWO_SIDED|95.0|-12.3|5.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.23|-12.30|0.43
91567056|NCT01177137|183023245|SUPERIORITY||Slope|-13.7|STANDARD_ERROR_OF_MEAN|4.24||0.001|TWO_SIDED|95.0|-22.02|-5.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-5.38|-22.02|0.001
91567057|NCT01177137|183023246|SUPERIORITY||Slope|3.71|STANDARD_ERROR_OF_MEAN|3.91||0.34|TWO_SIDED|95.0|-3.96|11.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||11.38|-3.96|0.34
91567058|NCT01177137|183023246|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|3.82||0.95|TWO_SIDED|95.0|-7.72|7.26||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.26|-7.72|0.95
91567059|NCT01177137|183023247|SUPERIORITY||Slope|-1.85|STANDARD_ERROR_OF_MEAN|3.69||0.62|TWO_SIDED|95.0|-9.07|5.38||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.38|-9.07|0.62
91567060|NCT01177137|183023247|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|3.58||0.21|TWO_SIDED|95.0|-11.48|2.55||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.55|-11.48|0.21
91567061|NCT01177137|183023248|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|3.39||0.97|TWO_SIDED|95.0|-6.78|6.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||6.52|-6.78|0.97
91567062|NCT01177137|183023248|SUPERIORITY||Slope|-3.02|STANDARD_ERROR_OF_MEAN|3.27||0.36|TWO_SIDED|95.0|-9.43|3.4||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||3.40|-9.43|0.36
91567063|NCT01177137|183023249|SUPERIORITY||Slope|1.24|STANDARD_ERROR_OF_MEAN|3.01||0.68|TWO_SIDED|95.0|-4.67|7.14||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.14|-4.67|0.68
91567064|NCT01177137|183023249|SUPERIORITY||Slope|-3.52|STANDARD_ERROR_OF_MEAN|2.93||0.23|TWO_SIDED|95.0|-9.26|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-9.26|0.23
91567065|NCT01177137|183023250|SUPERIORITY||Slope|-0.82|STANDARD_ERROR_OF_MEAN|1.27||0.52|TWO_SIDED|95.0|-3.3|1.66||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.66|-3.30|0.52
91567066|NCT01177137|183023250|SUPERIORITY||Slope|-2.81|STANDARD_ERROR_OF_MEAN|1.22||0.022|TWO_SIDED|95.0|-5.21|-0.41||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.41|-5.21|0.022
91567067|NCT01177137|183023251|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.96||0.72|TWO_SIDED|95.0|-1.54|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-1.54|0.72
91567068|NCT01177137|183023251|SUPERIORITY||Slope|-1.04|STANDARD_ERROR_OF_MEAN|0.91||0.26|TWO_SIDED|95.0|-2.83|0.75||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.75|-2.83|0.26
91567069|NCT01177137|183023252|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|0.55|1.78||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.78|0.55|0.30
91567070|NCT01177137|183023252|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
91567071|NCT00297778|183023253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0103||95.0|-3.4|-0.5|||ANCOVA|||||-0.5|-3.4|0.0103
91567072|NCT00297778|183023254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.758||||0.0535||95.0|0.992|3.115|||Regression, Logistic|||||3.115|0.992|0.0535
91567073|NCT00297778|183023255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0346||95.0|-1.5|-0.1|||ANCOVA|||||-0.1|-1.5|0.0346
91567074|NCT00297778|183023256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.5244||95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-1|0.5244
91567075|NCT00297778|183023257|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.141||95.0|0.0|0.0|||van Elteren (country stratification)|||||0|0|0.141
91567076|NCT00297778|183023258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.003||95.0|-1.9|-0.4|||ANCOVA|||||-0.4|-1.9|0.003
91567077|NCT00297778|183023259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0034||95.0|-3.7|-0.7|||ANCOVA|||||-0.7|-3.7|0.0034
91567078|NCT00297778|183023260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.0007||95.0|-5.4|-1.5|||ANCOVA|||||-1.5|-5.4|0.0007
91567079|NCT00297778|183023261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.821||||0.006||95.0|1.187|2.794|||Regression, Logistic|||||2.794|1.187|0.006
91567080|NCT00297778|183023262|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.3||||0.1925||95.0|-3.3|0.8|||van Elteren (country stratification)|||||0.8|-3.3|0.1925
91567081|NCT00297778|183023263|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.04||||0.0337||95.0|0.0|0.09|||Wilcoxon rank sum (Van Elteren's test)|||||0.09|0|0.0337
91567082|NCT00297778|183023264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.8471||95.0|-5.6|4.6|||ANCOVA|||||4.6|-5.6|0.8471
91567083|NCT00297778|183023265|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.0||||0.141|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank sum (Van Elteren's test)||95% Confidence interval is Distribution-free Confidence Interval (Moses).|N's exclude patients from the analysis set with incomplete data||0.0|0.0|0.1410
91567084|NCT00297778|183023266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5231|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||N's exclude patients from the analysis set with incomplete data||0.2|-0.5|0.5231
91567085|NCT02551692|183023302|OTHER||Partial sum of squares|855.65||||0.534|TWO_SIDED||||||ANOVA|||||||0.534
91567086|NCT02551692|183023303|OTHER||Partial sum of squares|29602.69||||0.26|TWO_SIDED||||||ANOVA|||||||0.26
91567087|NCT02551692|183023304|OTHER||Partial sum of squares|101.69||||0.318|TWO_SIDED||||||ANCOVA|||||||0.318
91567088|NCT00230971|183023334|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.6||||||95.0|-6.4|9.6|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||9.6|-6.4|
91567089|NCT00230971|183023335|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.8||||0.001||95.0|-8.8|12.5|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||12.5|-8.8|0.001
91567090|NCT00230971|183023336|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.7||||||95.0|-7.9|13.3|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|Group comparison of eradication + presumed eradication||13.3|-7.9|
91567091|NCT00230971|183023337|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|Treatment as a factor||Overall inpatient hospitalization||||0.750
91567092|NCT00230971|183023337|SUPERIORITY_OR_OTHER|||||||0.655|||||||ANOVA|Treatment as a factor||Primary inpatient hospitalization||||0.655
91567093|NCT00230971|183023337|SUPERIORITY_OR_OTHER|||||||0.191|||||||ANOVA|Treatment as a factor||ICU treatment||||0.191
91567094|NCT00230971|183023337|SUPERIORITY_OR_OTHER|||||||0.717|||||||ANOVA|Treatment as a factor||Inpatient hospitalization, non-ICU||||0.717
91567095|NCT01222533|183023409|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for Cmax,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|80.66|STANDARD_DEVIATION|43.4||0.4423||90.0|73.49|88.52||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||88.52|73.49|0.4423
91567096|NCT01222533|183023410|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for AUC0-6,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|75.99|STANDARD_DEVIATION|34.1||0.8683||90.0|70.44|81.98||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||81.98|70.44|0.8683
91567097|NCT01222533|183023411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.06|0.114|||||Tio R1.25-Placebo|||0.114|0.060|
91567098|NCT01222533|183023411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.074|0.128|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.128|0.074|<0.0001
91567099|NCT01222533|183023411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.094|0.148|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.148|0.094|<0.0001
91567100|NCT01222533|183023412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.012||||95.0|0.141|0.189|||||Tio R1.25-Placebo.|||0.189|0.141|
91567101|NCT01222533|183023412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.161|0.209|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.209|0.161|<0.0001
91567102|NCT01222533|183023412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.167|0.216|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.216|0.167|<0.0001
91567103|NCT01222533|183023413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.013||||95.0|0.13|0.18|||||Tio R1.25-Placebo|||0.180|0.130|
91567104|NCT01222533|183023413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.155|0.205|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.205|0.155|<0.0001
91567105|NCT01222533|183023413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.162|0.211|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.211|0.162|<0.0001
91567106|NCT01222533|183023414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.028||||95.0|0.083|0.194|||||Tio R1.25-Placebo|||0.194|0.083|
91567107|NCT01222533|183023414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.133|0.244|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.244|0.133|<0.0001
91567108|NCT01222533|183023414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.18|0.292|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.292|0.180|<0.0001
91567109|NCT01222533|183023415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.022||||95.0|0.241|0.326|||||Tio R1.25-Placebo|||0.326|0.241|
91567110|NCT01222533|183023415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.276|0.362|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.362|0.276|<0.0001
91567111|NCT01222533|183023415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.292|0.378|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.378|0.292|<0.0001
91567112|NCT01222533|183023416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.023||||95.0|0.236|0.325|||||Tio R1.25-Placebo|||0.325|0.236|
91567113|NCT01222533|183023416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.279|0.369|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.369|0.279|<0.0001
91567114|NCT01222533|183023416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.294|0.384|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.384|0.294|<0.0001
91567115|NCT00460564|183023445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.83|||<|0.001||95.0|-10.567|-3.093|||t-test, 2 sided|||||-3.093|-10.567|<0.001
91567116|NCT01936324|183023468|OTHER|||||||0.0003|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center.||||||0.0003
91567117|NCT01936324|183023469|OTHER|||||||0.0032|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center||||||0.0032
91567118|NCT01936324|183023470|OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study center||||||0.0070
91567119|NCT03226106|183023475|SUPERIORITY||Mean Difference (Final Values)|930.51||||0.024|TWO_SIDED|95.0|41.65|1819.36||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1819.36|41.65|0.024
91567120|NCT03226106|183023476|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.584|TWO_SIDED|95.0|-0.67|2.07||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.07|-0.67|0.584
91567121|NCT03226106|183023477|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.724|TWO_SIDED|95.0|-1.4|1.32||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1.32|-1.40|0.724
91567122|NCT03226106|183023478|SUPERIORITY||Mean Difference (Final Values)|7.49||||0.547|TWO_SIDED|95.0|-18.9|33.89||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||33.89|-18.90|0.547
91567123|NCT03226106|183023479|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.716|TWO_SIDED|95.0|-21.67|31.54||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||31.54|-21.67|0.716
91567124|NCT03226106|183023480|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.946|TWO_SIDED|95.0|-0.88|0.82||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.82|-0.88|0.946
91567125|NCT03226106|183023481|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.906|TWO_SIDED|95.0|-1.08|0.52||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.52|-1.08|0.906
91567126|NCT03226106|183023482|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.873|TWO_SIDED|95.0|-7.59|4.49||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.49|-7.59|0.873
91567127|NCT03226106|183023483|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.241|TWO_SIDED|95.0|-12.48|-0.04||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||-0.04|-12.48|0.241
91567128|NCT03226106|183023484|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.223|TWO_SIDED|95.0|-0.39|6.12||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||6.12|-0.39|0.223
91567129|NCT03226106|183023485|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.388|TWO_SIDED|95.0|-2.19|4.53||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.53|-2.19|0.388
91567130|NCT03226106|183023486|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.88|TWO_SIDED|95.0|-4.08|2.68||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.68|-4.08|0.88
91567131|NCT03226106|183023487|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.85|TWO_SIDED|95.0|-2.63|4.17||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.17|-2.63|0.85
91567132|NCT03226106|183023488|SUPERIORITY||Mean Difference (Final Values)|559.81||||0.101|TWO_SIDED|95.0|-405.01|1524.62||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1524.62|-405.01|0.101
91567133|NCT04349644|183023489|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent vari- ables.||||||0.016|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.016
91567134|NCT04349644|183023489|OTHER|"A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each depen- dent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate.~Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables."||||||0.288|||||||ANCOVA|Follow-up ANCOVA while controlling Pretest.||||||0.288
91567135|NCT04349644|183023490|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.932|||||||ANCOVA|Posttest ANCOVA controlling pretest value for CASS Vocal Expressiveness.||||||0.932
91567136|NCT04349644|183023490|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.221|||||||ANCOVA|Posttest ANCOVA controlling for pretest for CASS Quality of Rapport.||||||0.221
91567137|NCT04349644|183023490|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.873|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Vocal Expressiveness.||||||0.873
91567138|NCT04349644|183023490|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.512|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Quality of Rapport.||||||0.512
91567139|NCT04349644|183023491|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.05|||||||ANCOVA|Posttest ANCOVA controlling for Pretest.||||||0.05
91567140|NCT04349644|183023491|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.393|||||||ANCOVA|Follow-up ANCOVA controlling for Pretest.||||||0.393
91567141|NCT04349644|183023492|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.917|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.917
91567142|NCT04349644|183023492|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.963|||||||ANCOVA|Follow-up ANCOVA while controlling for pretest.||||||0.963
91567143|NCT00702650|183023501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||One-Sample Binomial (Wald) test, 2-sided|||||||<0.001
91567144|NCT00702650|183023506|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
91567145|NCT00702650|183023506|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
91567146|NCT00702650|183023506|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
91567147|NCT00702650|183023506|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
91567148|NCT00702650|183023506|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
91567149|NCT00702650|183023507|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||0.0254
91567150|NCT00702650|183023507|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||<0.0001
91567151|NCT01309243|183023516|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL (response rate, as defined by the snapshot analysis algorithm) at Week 48.~Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL at Week 48."|Difference in the response rates|4.1|||||TWO_SIDED|95.0|-1.1|9.2|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|"The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI \> -12%).~700 subjects allocated 1:1 to either treatment arm was predicted to give \> 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48."||9.2|-1.1|
91567152|NCT01309243|183023517|SUPERIORITY_OR_OTHER||Difference in the response rates|5.5|||||TWO_SIDED|95.0|-0.6|11.5|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|||11.5|-0.6|
91567153|NCT01309243|183023518|SUPERIORITY_OR_OTHER||Difference in LSM|11.0||||0.34|TWO_SIDED|95.0|-11.0|32.0||The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||32|-11|0.34
91567154|NCT01309243|183023519|SUPERIORITY_OR_OTHER||Difference in LSM|20.0||||0.17|TWO_SIDED|95.0|-9.0|49.0||The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||49|-9|0.17
91567155|NCT01309243|183023520|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
91567156|NCT01309243|183023521|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
91567157|NCT01309243|183023522|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
91567158|NCT01309243|183023523|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
91567159|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67.|GMT ratio|1.9|||<|0.001|TWO_SIDED|95.0|1.7|2.14||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.14|1.70|< 0.001
91567160|NCT00943722|183023527|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.63|2.06||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.06|1.63|< 0.001
91567161|NCT00943722|183023527|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.77|2.22||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.22|1.77|< 0.001
91567162|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.13|2.8||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||2.80|2.13|< 0.001
91567163|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.21|2.85||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||2.85|2.21|< 0.001
91567164|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.87|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.36|1.87|< 0.001
91567165|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.27|3.03||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.03|2.27|< 0.001
91567166|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.22|||<|0.001|TWO_SIDED|95.0|1.97|2.51||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.51|1.97|< 0.001
91567167|NCT00943722|183023527|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.18|||<|0.001|TWO_SIDED|95.0|1.93|2.45||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.45|1.93|< 0.001
91567168|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.31|||<|0.001|TWO_SIDED|95.0|2.07|2.59||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.59|2.07|< 0.001
91567169|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.88|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.36|1.88|< 0.001
91567170|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.19|2.74||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.74|2.19|< 0.001
91567171|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.2|||<|0.001|TWO_SIDED|95.0|2.8|3.65||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||3.65|2.80|< 0.001
91567172|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.95|||<|0.001|TWO_SIDED|95.0|2.6|3.34||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||3.34|2.60|< 0.001
91567173|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.57|||<|0.001|TWO_SIDED|95.0|2.29|2.88||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.88|2.29|< 0.001
91567174|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.33|||<|0.001|TWO_SIDED|95.0|2.89|3.84||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.84|2.89|< 0.001
91567175|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.47|||<|0.001|TWO_SIDED|95.0|2.19|2.79||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.79|2.19|< 0.001
91567176|NCT00943722|183023528|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.66|||<|0.001|TWO_SIDED|95.0|2.37|2.98||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.98|2.37|< 0.001
91567177|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||1.08|0.88|
91567178|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.03|||||TWO_SIDED|95.0|0.93|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.16|0.93|
91567179|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.06|||||TWO_SIDED|95.0|0.95|1.19|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.19|0.95|
91567180|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||1.11|0.90|
91567181|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
91567182|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
91567183|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||1.06|0.86|
91567184|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.12|0.90|
91567185|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.17|0.94|
91567186|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||1.14|0.89|
91567187|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.98|
91567188|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.97|
91567189|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||1.13|0.89|
91567190|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.91|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.16|0.91|
91567191|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.15|0.90|
91567192|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||1.16|0.94|
91567193|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.17|0.94|
91567194|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.12|0.90|
91567195|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.84|||||TWO_SIDED|95.0|0.73|0.95|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.95|0.73|
91567196|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.04|||||TWO_SIDED|95.0|0.91|1.18|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.18|0.91|
91567197|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.42|1.08|
91567198|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||1.03|0.83|
91567199|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.85|1.07|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.07|0.85|
91567200|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.03|||||TWO_SIDED|95.0|0.92|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.16|0.92|
91567201|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||1.06|0.86|
91567202|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.07|||||TWO_SIDED|95.0|0.96|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.20|0.96|
91567203|NCT00943722|183023529|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.12|||||TWO_SIDED|95.0|1.0|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.26|1.00|
91567204|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.8|< 0.001
91567205|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
91567206|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
91567207|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.5|-0.8|< 0.001
91567208|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
91567209|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
91567210|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.8|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||1.8|-0.6|< 0.001
91567211|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
91567212|NCT00943722|183023533|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
91567213|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.7|< 0.001
91567214|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
91567215|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
91567216|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.6|-0.4|< 0.001
91567217|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
91567218|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
91567219|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.1|2.0|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||2.0|-0.1|< 0.001
91567220|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
91567221|NCT00943722|183023534|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
91567222|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||0.9|-0.9|
91567223|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.5|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
91567224|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.6|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
91567225|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||0.7|-0.7|
91567226|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
91567227|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
91567228|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||0.7|-0.7|
91567229|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
91567230|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
91567231|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||0.5|-1.1|
91567232|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.1|-0.7|
91567233|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.3|-0.4|
91567234|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||0.7|-0.7|
91567235|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.6|
91567236|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.5|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.5|
91567237|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||0.7|-0.7|
91567238|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
91567239|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
91567240|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.5|-1.1|
91567241|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.1|-0.7|
91567242|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.3|-0.4|
91567243|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||0.7|-0.7|
91567244|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.3|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
91567245|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
91567246|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||0.7|-0.7|
91567247|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
91567248|NCT00943722|183023535|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
91567249|NCT01772823|183023551|OTHER|||||||0.7513||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Size of the Pill) differ between intervention arms."|Chi-squared|||||||0.7513
91567250|NCT01772823|183023552|OTHER|||||||0.8281||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Taste of the Pill) differ between intervention arms."|Chi-squared|Pearson Chi-Square||||||0.8281
91567251|NCT01772823|183023553|OTHER|||||||0.3761||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Color of the Pill) differ between intervention arms."|Chi-squared|||||||0.3761
91567252|NCT01772823|183023554|OTHER|||||||0.4359||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking the pill every day) differ between intervention arms."|Chi-squared|||||||0.4359
91567253|NCT01772823|183023555|OTHER|||||||0.3801||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking part in the study) differ between intervention arms."|Chi-squared|||||||0.3801
91567254|NCT01772823|183023556|OTHER|||||||0.1968||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on HIV test at every visit) differ between intervention arms."|Chi-squared|||||||0.1968
91567255|NCT01772823|183023557|OTHER|||||||0.1226||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Risk Reduction counseling at every visit) differ between intervention arms."|Chi-squared|||||||0.1226
91567256|NCT01772823|183023558|OTHER|||||||0.0994||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Questions about sexual behavior) differ between intervention arms."|Chi-squared|||||||0.0994
91567257|NCT01772823|183023559|OTHER|||||||0.5285||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Physician exam) differ between intervention arms."|Chi-squared|||||||0.5285
91567258|NCT01772823|183023563|OTHER|||||||0.0001||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0001
91567259|NCT01772823|183023564|OTHER|||||||0.0098||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0098
91567260|NCT01772823|183023565|OTHER|||||||0.0766||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0766
91567261|NCT01772823|183023566|OTHER|||||||0.1581||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1581
91567262|NCT01772823|183023567|OTHER|||||||0.43||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.4300
91567263|NCT01772823|183023568|OTHER|||||||0.1201||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1201
91567264|NCT01772823|183023569|OTHER|||||||0.1682||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1682
91567265|NCT01772823|183023570|OTHER|||||||0.2747||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.2747
91567266|NCT01772823|183023571|OTHER|||||||0.0046||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0046
91567267|NCT01772823|183023572|OTHER|||||||0.029||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0290
91567268|NCT01772823|183023573|OTHER|||||||0.107|||||||Kruskal-Wallis|||||||0.1070
91567269|NCT01772823|183023575|OTHER|||||||0.2991||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.2991
91567270|NCT01772823|183023576|OTHER|||||||0.0298||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.0298
91567271|NCT01772823|183023577|OTHER|||||||0.8643||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.8643
91567272|NCT01772823|183023578|OTHER|||||||0.9037||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.9037
91567273|NCT01772823|183023579|OTHER|||||||0.5279|||||||Kruskal-Wallis|||||||0.5279
91567274|NCT01772823|183023580|OTHER|||||||0.5369||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.5369
91567275|NCT01772823|183023583|OTHER|||||||0.2193||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2193
91567276|NCT01772823|183023584|OTHER|||||||0.1255||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1255
91567277|NCT01772823|183023585|OTHER|||||||0.0706||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0706
91567278|NCT01772823|183023586|OTHER|||||||0.0088||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0088
91567279|NCT01772823|183023587|OTHER|||||||0.2482||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2482
91567280|NCT01772823|183023588|OTHER|||||||0.1647||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1647
91567281|NCT01772823|183023589|OTHER|||||||0.688||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.6880
91567282|NCT01772823|183023590|OTHER|||||||0.2881||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2881
91567283|NCT01772823|183023591|OTHER|||||||0.2223||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2223
91567284|NCT01772823|183023592|OTHER|||||||0.0617||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0617
91567285|NCT01772823|183023593|OTHER|||||||0.0868||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0868
91567286|NCT01772823|183023594|OTHER|||||||0.1847||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1847
91567287|NCT01772823|183023595|OTHER|||||||0.0226||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0226
91567288|NCT01037413|183023599|SUPERIORITY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|95.0|-21.3|-8.1|||t-test, 2 sided|||Comparison within the participant between EXC 001 and placebo.||-8.1|-21.3|<0.001
91567289|NCT01037413|183023600|SUPERIORITY||Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-21.2|-8.3|||t-test, 2 sided|||Week 8: Comparison within the participant between EXC 001 and placebo.||-8.3|-21.2|<0.001
91567290|NCT01037413|183023600|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-34.3|-17.7|||t-test, 2 sided|||Week 24: Comparison within the participant between EXC 001 and placebo.||-17.7|-34.3|<0.001
91567291|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.033|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.033
91567292|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.003|TWO_SIDED|95.0|-1.9|-0.4|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.9|0.003
91567293|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.5|<0.001
91567294|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.7|-1.0|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-1.0|-2.7|<0.001
91567295|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.012|TWO_SIDED|95.0|-1.9|-0.3|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.9|0.012
91567296|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.003|TWO_SIDED|95.0|-2.4|-0.5|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||-0.5|-2.4|0.003
91567297|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.6|-1.1|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.1|-2.6|<0.001
91567298|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|-12.7|-4.0|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-4.0|-12.7|<0.001
91567299|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.2|-1.4|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||-1.4|-3.2|<0.001
91567300|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.9|-0.9|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.9|-2.9|<0.001
91567301|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.001|TWO_SIDED|95.0|-2.8|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.8|0.001
91567302|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.6|-1.3|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||-1.3|-3.6|<0.001
91567303|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.005|TWO_SIDED|95.0|-3.2|-0.7|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.7|-3.2|0.005
91567304|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.1|-1.2|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||-1.2|-3.1|<0.001
91567305|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.5|-3.3|<0.001
91567306|NCT01037413|183023601|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-17.7|-7.4|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-7.4|-17.7|<0.001
91567307|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.067|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.067
91567308|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.413|TWO_SIDED|95.0|-1.2|0.5|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.5|-1.2|0.413
91567309|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.401|TWO_SIDED|95.0|-1.6|0.7|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.7|-1.6|0.401
91567310|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.083|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-2.4|0.083
91567311|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.052|TWO_SIDED|95.0|-2.3|0.0|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.0|-2.3|0.052
91567312|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.036|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.036
91567313|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.045|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-2.1|0.045
91567314|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.054|TWO_SIDED|95.0|-9.9|0.1|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.1|-9.9|0.054
91567315|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.065|TWO_SIDED|95.0|-8.2|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-8.2|0.065
91567316|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.079|TWO_SIDED|95.0|-2.0|0.1|||t-test, 2 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.1|-2.0|0.079
91567317|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.158|TWO_SIDED|95.0|-1.5|0.3|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.3|-1.5|0.158
91567318|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.01|TWO_SIDED|95.0|-3.0|-0.5|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||-0.5|-3.0|0.010
91567319|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.003|TWO_SIDED|95.0|-3.5|-0.8|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||-0.8|-3.5|0.003
91567320|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.005|TWO_SIDED|95.0|-4.0|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-4.0|0.005
91567321|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.032|TWO_SIDED|95.0|-3.5|-0.2|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.2|-3.5|0.032
91567322|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.003|TWO_SIDED|95.0|-3.8|-0.9|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.9|-3.8|0.003
91567323|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.006|TWO_SIDED|95.0|-16.4|-3.1|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.1|-16.4|0.006
91567324|NCT01037413|183023602|SUPERIORITY||Mean Difference (Final Values)|-8.2||||0.004|TWO_SIDED|95.0|-13.4|-3.0|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.0|-13.4|0.004
91567325|NCT02367105|183023625|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.58|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariate||||||0.58
91567326|NCT02367105|183023626|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
91567327|NCT02367105|183023627|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||.97
91567328|NCT02367105|183023628|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.56|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.56
91567329|NCT02367105|183023629|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
91567330|NCT02367105|183023630|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
91567331|NCT02367105|183023631|SUPERIORITY||Mean Difference (Final Values)|-42.0||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
91567332|NCT02367105|183023632|SUPERIORITY||Mean Difference (Final Values)|-29.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.67
91567333|NCT02367105|183023633|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.003|TWO_SIDED||||||Mixed Models Analysis|Baseline valued adjusted||||||0.003
91567334|NCT02367105|183023634|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
91567335|NCT02367105|183023635|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.94|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.94
91567336|NCT02367105|183023636|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.41
91567337|NCT02367105|183023637|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.46|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.46
91567338|NCT02367105|183023638|SUPERIORITY|Baseline value adjusted|Mean Difference (Final Values)|0.6||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
91567339|NCT02367105|183023639|SUPERIORITY||Mean Difference (Final Values)|-0.284||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||.003
91567340|NCT02367105|183023640|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years of education as covariates||||||.16
91567341|NCT02367105|183023641|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.21|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.21
91567342|NCT02367105|183023642|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.41
91567343|NCT02367105|183023643|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years if education as covariates||||||.03
91567344|NCT02367105|183023644|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.03
91567345|NCT02367105|183023645|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.18|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.18
91567346|NCT02367105|183023646|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.1|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.10
91567347|NCT02367105|183023647|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.65
91567348|NCT02367105|183023648|SUPERIORITY||Mean Difference (Final Values)|0.553||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
91567349|NCT02367105|183023649|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
91567350|NCT02367105|183023650|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.35|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.35
91567351|NCT02367105|183023651|SUPERIORITY||Median Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.65
91567352|NCT02367105|183023652|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.27|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.27
91567353|NCT02367105|183023653|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.39|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.39
91567354|NCT02367105|183023654|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
91567355|NCT02367105|183023655|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.90
91567356|NCT02367105|183023656|SUPERIORITY||Mean Difference (Final Values)|-252.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||<0.001
91567357|NCT02367105|183023657|SUPERIORITY||Mean Difference (Final Values)|-24.9|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value as covariates||||||<0.001
91567358|NCT02367105|183023658|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||<0.001
91567359|NCT02367105|183023659|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.31|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.31
91567360|NCT02367105|183023660|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.42|TWO_SIDED|||||Baseline values as covariates|Mixed Models Analysis|||||||0.42
91567361|NCT02367105|183023661|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
91567362|NCT02367105|183023662|SUPERIORITY||Mean Difference (Final Values)|-13.1||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.23
91567363|NCT02367105|183023663|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
91567364|NCT02367105|183023664|SUPERIORITY||Mean Difference (Net)|-1.0||||0.36|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.36
91567365|NCT02367105|183023665|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.23
91567366|NCT02367105|183023666|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline values adjusted||||||0.69
91567367|NCT02367105|183023667|SUPERIORITY||Number of participants|0.0|||>|0.05|TWO_SIDED|||||A priori threshold = voxel p\<.001, cluster p\<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.|t-test, 2 sided|||||||>.05
91567368|NCT02367105|183023668|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.|t-test, 2 sided|||6 months vs Baseline||||0.37
91567369|NCT02367105|183023668|SUPERIORITY||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate|t-test, 2 sided|||6 months vs Baseline||||.02
91567370|NCT02367105|183023669|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.05|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||.05
91567371|NCT02367105|183023669|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.3|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||0.3
91567372|NCT01182103|183023679|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91567373|NCT01182103|183023680|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91567374|NCT01182103|183023681|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
91567375|NCT00812838|183023694|SUPERIORITY|||||||0.5154||||||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|t-test, 2 sided|||||||0.5154
91567376|NCT00812838|183023695|SUPERIORITY|||||||0.3009||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||"This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.~This analysis pertains to both categories"||||0.3009
91567377|NCT00812838|183023696|SUPERIORITY|||||||0.0166||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0166
91567378|NCT00812838|183023697|SUPERIORITY|||||||0.8566||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||.8566
91567379|NCT00812838|183023698|SUPERIORITY|||||||0.0286||||||Threshold for statistical significance is \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0286
91567380|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-79.33|||<|0.001|TWO_SIDED|95.0|-87.54|-65.73|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-65.73|-87.54|< 0.001
91567381|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-71.16|||<|0.001|TWO_SIDED|95.0|-82.67|-52.0|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.00|-82.67|< 0.001
91567382|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-79.52|||<|0.001|TWO_SIDED|95.0|-88.29|-64.17|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.17|-88.29|< 0.001
91567383|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-72.34|||<|0.001|TWO_SIDED|95.0|-83.32|-54.13|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-54.13|-83.32|< 0.001
91567384|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-73.03|||<|0.001|TWO_SIDED|95.0|-83.79|-55.11|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-55.11|-83.79|< 0.001
91567385|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-71.88|||<|0.001|TWO_SIDED|95.0|-83.93|-50.82|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-50.82|-83.93|< 0.001
91567386|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-68.51|||<|0.001|TWO_SIDED|95.0|-81.01|-47.78|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-47.78|-81.01|< 0.001
91567387|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-81.06|||<|0.001|TWO_SIDED|95.0|-88.62|-68.49|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-68.49|-88.62|< 0.001
91567388|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-79.04|||<|0.001|TWO_SIDED|95.0|-88.02|-63.34|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-63.34|-88.02|< 0.001
91567389|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-32.7||||0.25|TWO_SIDED|95.0|-65.71|32.1|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||32.10|-65.71|0.25
91567390|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|3.44||||0.9|TWO_SIDED|95.0|-40.78|80.66|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||80.66|-40.78|0.90
91567391|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-40.53||||0.091|TWO_SIDED|95.0|-67.5|8.82|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||8.82|-67.50|0.091
91567392|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|13.33||||0.73|TWO_SIDED|95.0|-44.39|130.94|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||130.94|-44.39|0.73
91567393|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-80.02||||0.001|TWO_SIDED|95.0|-91.53|-52.87|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.87|-91.53|0.001
91567394|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-87.6|||<|0.001|TWO_SIDED|95.0|-94.53|-71.88|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-71.88|-94.53|< 0.001
91567395|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Rratio|-79.81||||0.001|TWO_SIDED|95.0|-91.44|-52.37|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.37|-91.44|0.001
91567396|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-83.66|||<|0.001|TWO_SIDED|95.0|-92.79|-62.95|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-62.95|-92.79|< 0.001
91567397|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-81.97|||<|0.001|TWO_SIDED|95.0|-92.35|-57.46|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-57.46|-92.35|< 0.001
91567398|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-84.39|||<|0.001|TWO_SIDED|95.0|-93.12|-64.6|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.60|-93.12|< 0.001
91567399|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|43.1||||0.47|TWO_SIDED|95.0|-47.06|286.83|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||286.83|-47.06|0.47
91567400|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-68.58||||0.02|TWO_SIDED|95.0|-88.02|-17.63|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-17.63|-88.02|0.020
91567401|NCT01723514|183023706|SUPERIORITY||LS Geometric Mean Ratio|-54.32||||0.11|TWO_SIDED|95.0|-82.58|19.75|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||19.75|-82.58|0.11
91567402|NCT00802438|183023720|OTHER||||||<|0.0001||||||A two-sided p-value\<0.05 was considered significant. Analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC.).|t-test, 2 sided|||Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||<0.0001
91567403|NCT00802438|183023721|OTHER|Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||||0.01|||||||t-test, 2 sided|||||||0.01
91567404|NCT02101268|183023735|SUPERIORITY||Proportion Difference - Stratified CMH|0.01||||0.9|TWO_SIDED|95.0|-0.09|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.09|0.90
91567405|NCT02101268|183023736|SUPERIORITY||Proportion Difference - Stratified CMH|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||||0.32|0.09|< 0.001
91567406|NCT02101268|183023737|SUPERIORITY||Rate ratio|0.8||||0.38|TWO_SIDED|95.0|0.49|1.31|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||1.31|0.49|0.38
91567407|NCT02101268|183023738|SUPERIORITY||Proportion Difference - Stratified CMH|0.23||||0.001|TWO_SIDED|95.0|0.09|0.37|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.37|0.09|0.001
91567408|NCT02101268|183023739|SUPERIORITY||Proportion Difference - Stratified CMH|-0.13||||0.1|TWO_SIDED|95.0|-0.29|0.03|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||0.03|-0.29|0.10
91567409|NCT00740870|183023740|SUPERIORITY||Kaplan-Meier Rate|74.2|||<|0.0001|ONE_SIDED|95.0|67.1||||Z test||||||67.1|<0.0001
91567410|NCT02831998|183023767|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.188|0.083||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.083|-0.188|
91567411|NCT02831998|183023767|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Median Difference (Final Values)|2.627|||||TWO_SIDED|95.0|2.396|2.858||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.858|2.396|
91567412|NCT02831998|183023768|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.102|0.065||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.065|-0.102|
91567413|NCT02831998|183023768|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.909|||||TWO_SIDED|95.0|1.766|2.053||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.053|1.766|
91567414|NCT00839332|183023773|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.333|||||TWO_SIDED||||||||Inference about survival was made using a Bayesian posterior probability. The combination treatment would have been considered superior to gemcitabine alone if the posterior probability of superiority exceeded 0.8.|||||
91567415|NCT01196741|183023872|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.57|TWO_SIDED|95.0|0.65|1.23|||Regression, Cox|||||1.23|0.65|0.57
91567416|NCT01196741|183023873|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Cox|||||||0.81
91567417|NCT01196741|183023876|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
91567418|NCT01196741|183023878|SUPERIORITY_OR_OTHER|||||||0.99|||||||Regression, Cox|||||||0.99
91567419|NCT01064856|183023904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Pearson's chi-square|||||||0.006
91567420|NCT01064856|183023906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||<0.001
91567421|NCT01064856|183023907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.003
91567422|NCT01064856|183023908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.051
91567423|NCT05329402|183023921|NON_INFERIORITY|"The non-inferiority hypothesis is tenable if the lower limit of 95% confidence interval of the difference in the primary effectiveness evaluation indicator device cutting and anastomosis success rate between the test group and the control group is greater than the non-inferiority critical value (-10%)."|Mean Difference (Final Values)|0.0||||0.9727|TWO_SIDED|95.0|-0.0285|0.0273|||Wald|||||0.0273|-0.0285|0.9727
91567424|NCT01679613|183023922|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|160.48|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|148.245|173.736||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %).~The standard deviation is actually the geometric coefficient of variation (gCV)."|||173.736|148.245|1.0000
91567425|NCT01679613|183023923|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|179.62|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|157.557|204.779||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV (in %).~Ratio calculated as nintedanib+ketoconazole divided by nintedanib"|||204.779|157.557|1.0000
91567426|NCT01679613|183023924|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|168.09|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|155.252|181.981||p-value for ratio outside interval 0.8 to 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV.~Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %)."|||181.981|155.252|1.000
91567427|NCT02799745|183023958|SUPERIORITY||Hazard Ratio (HR)|0.542||||0.016|TWO_SIDED|95.0|0.33|0.892||P-value was from a 2-sided stratified log-rank test.|Log Rank||HR, 95% CI for HR:based on a Cox regression model assuming proportional hazards with treatment, prostate cancer risk,type of biopsy,baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.892|0.330|0.016
91567428|NCT02799745|183023960|SUPERIORITY||Odds Ratio (OR)|3.5||||0|TWO_SIDED|95.0|1.76|6.92||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 12||6.92|1.76|0.00
91567429|NCT02799745|183023960|SUPERIORITY||Odds Ratio (OR)|1.6||||0.289|TWO_SIDED|95.0|0.66|4.0||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 24||4.00|0.66|0.289
91567430|NCT02799745|183023961|SUPERIORITY||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|2.398|<|0.001|TWO_SIDED|95.0|-14.79|-5.34||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|Mixed model repeated measure(MMRM) with treatment group, prostate cancer risk(low/intermediate), type of biopsy(mpMRI-targeted/non-mpMRI-targeted), visit, visit-by-treatment, baseline scores as fixed factors, site and participants as random factors.|Change at month 12||-5.34|-14.79|<0.001
91567431|NCT02799745|183023961|SUPERIORITY||LS mean difference|-5.15|STANDARD_ERROR_OF_MEAN|3.174||0.1063|TWO_SIDED|95.0|-11.4|1.11||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|MMRM with treatment group, prostate cancer risk (low vs. intermediate), type of biopsy (mpMRI targeted vs. non mpMRI targeted), visit, visit-by-treatment and baseline scores were the fixed factors, and site and participants were the random factors.|Change at month 24||1.11|-11.40|0.1063
91567432|NCT02799745|183023962|SUPERIORITY||Hazard Ratio (HR)|0.714||||0.032|TWO_SIDED|95.0|0.525|0.972||P-value: from a 2-sided, stratified log-rank test.|Log Rank||HR and 95% CI for HR:based on Cox regression model assuming proportional hazards with treatment, prostate cancer risk, type of biopsy, baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.972|0.525|0.032
91567433|NCT02799745|183023963|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.08|0.26||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR:from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 12||0.26|0.08|0.000
91567434|NCT02799745|183023963|SUPERIORITY||Odds Ratio (OR)|1.1||||0.807|TWO_SIDED|95.0|0.37|3.53||P-value: based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 24||3.53|0.37|0.807
91567435|NCT02799745|183023963|SUPERIORITY||Odds Ratio (OR)|1.0||||0.931|TWO_SIDED|95.0|0.5|2.15||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of study||2.15|0.50|0.931
91567436|NCT03469492|183023998|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
91567437|NCT03469492|183024002|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
91567438|NCT03469492|183024005|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91567439|NCT03469492|183024006|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91567440|NCT01726049|183024008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.5|-0.3||||||||-0.3|-4.5|
91567441|NCT01726049|183024008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-7.1|-2.3||||||||-2.3|-7.1|
91567442|NCT01726049|183024009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.9|1.4||||||||1.4|-0.9|
91567443|NCT01726049|183024009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-0.3|1.6||||||||1.6|-0.3|
91567444|NCT01726049|183024010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||||0.1|-0.9|
91567445|NCT01726049|183024010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||||0.1|-0.5|
91567446|NCT01726049|183024011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.9|1.0||||||||1.0|-1.9|
91567447|NCT01726049|183024011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|||||TWO_SIDED|95.0|-5.2|-1.8||||||||-1.8|-5.2|
91567448|NCT02161406|183024026|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
91567449|NCT02161406|183024027|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
91567450|NCT02161406|183024028|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
91567451|NCT02161406|183024029|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91567452|NCT02161406|183024030|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
91567453|NCT02161406|183024031|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
91567454|NCT02161406|183024032|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
91567455|NCT02161406|183024033|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
91567456|NCT02161406|183024034|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91567457|NCT02161406|183024035|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
91567458|NCT02161406|183024036|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
91567459|NCT02161406|183024037|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
91567460|NCT02161406|183024038|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
91567461|NCT02161406|183024039|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
91567462|NCT02161406|183024040|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
91567463|NCT02161406|183024041|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||||||0.81
91567464|NCT02161406|183024042|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
91567465|NCT02161406|183024043|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
91567466|NCT02161406|183024044|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
91567467|NCT02161406|183024045|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
91567468|NCT02161406|183024046|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
91567469|NCT02161406|183024047|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
91567470|NCT02161406|183024048|SUPERIORITY|||||||0.03|||||||van Elteren test|The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.||||||0.03
91567471|NCT02161406|183024049|SUPERIORITY|||||||0.1769|||||||Mixed Models Analysis|||||||0.1769
91567472|NCT02161406|183024050|SUPERIORITY|||||||0.9075|||||||Mixed Models Analysis|||||||0.9075
91567473|NCT02161406|183024051|SUPERIORITY|||||||0.5831|||||||Mixed Models Analysis|||||||0.5831
91567474|NCT02161406|183024052|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|||||||0.0193
91567475|NCT02161406|183024053|SUPERIORITY|||||||0.0097|||||||Mixed Models Analysis|||||||0.0097
91567476|NCT02161406|183024054|SUPERIORITY|||||||0.0751|||||||Mixed Models Analysis|||||||0.0751
91567477|NCT02161406|183024055|SUPERIORITY|||||||0.4927|||||||Mixed Models Analysis|||||||0.4927
91567478|NCT02161406|183024056|SUPERIORITY|||||||0.1604|||||||Mixed Models Analysis|||||||0.1604
91567479|NCT02161406|183024057|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
91567480|NCT02161406|183024058|SUPERIORITY|||||||0.1679|||||||Mixed Models Analysis|||||||0.1679
91567481|NCT02161406|183024059|SUPERIORITY|||||||0.2906|||||||Mixed Models Analysis|||||||0.2906
91567482|NCT01929876|183024060|SUPERIORITY_OR_OTHER||Ratio of least squares means|316.6|||||TWO_SIDED|90.0|268.1|374.0|||||LS means from analysis of variance (ANOVA), calculated by transforming the natural log means back to the linear scale (that is, geometric LS mean).|Ratio of Least squares (LS) means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent).||374.0|268.1|
91567483|NCT01929876|183024061|SUPERIORITY_OR_OTHER||Ratio of LS means|672.3|||||TWO_SIDED|90.0|563.7|801.9|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|Only participants with PK parameter data from both Period 1 Day 1 and Period 2 Day 4 (n=11) were included for statistical analyses.||801.9|563.7|
91567484|NCT01929876|183024063|SUPERIORITY_OR_OTHER||Ratio of LS means|583.9|||||TWO_SIDED|90.0|488.2|698.2|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|||698.2|488.2|
91567485|NCT01343251|183024070|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Chi-squared|||||||0.48
91567486|NCT01343251|183024071|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
91567487|NCT01343251|183024072|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||SF-36 Test 1 Total Score|t-test, 2 sided|||||||0.49
91567488|NCT01343251|183024072|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||SF-36 Test 2 Total Score|t-test, 2 sided|||||||0.91
91567489|NCT01343251|183024072|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||SF-36 Test 3 Total Score|t-test, 2 sided|||||||0.67
91567490|NCT01343251|183024072|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SF-36 Test 4 Total Score|t-test, 2 sided|||||||<0.001
91567491|NCT01343251|183024073|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||||||0.04
91567492|NCT01343251|183024074|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Chi-squared|||||||0.90
91567493|NCT01468077|183024075|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0164|||||TWO_SIDED|95.0|-0.2685|0.2988|||||The CI (confidence interval) is calculated by Exact method based on binomial distribution.|||0.2988|-0.2685|
91567494|NCT03024996|183024095|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.495|TWO_SIDED|95.0|0.75|1.15|||Log Rank|||||1.15|0.75|0.4950
91567495|NCT03024996|183024096|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8868||95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8868
91567496|NCT03024996|183024097|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.201|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||||1.10|0.63|0.2010
91567497|NCT03024996|183024098|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2811|TWO_SIDED|95.0|0.69|1.12|||Log Rank|||||1.12|0.69|0.2811
91567498|NCT03024996|183024099|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0735|TWO_SIDED|95.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.0735
91567499|NCT03024996|183024100|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1396|TWO_SIDED|95.0|0.67|1.06|||Log Rank|||||1.06|0.67|0.1396
91567500|NCT03024996|183024101|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4762|TWO_SIDED|95.0|0.55|1.33|||Log Rank|||||1.33|0.55|0.4762
91567501|NCT03024996|183024102|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.5111|TWO_SIDED|95.0|0.74|1.16|||Log Rank|||||1.16|0.74|0.5111
91567502|NCT03119688|183024176|NON_INFERIORITY|The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.|Mean Difference (Net)|-0.077||||0.1769|TWO_SIDED|90.0|-0.1707|0.0169||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.||0.0169|-0.1707|0.1769
91567503|NCT03119688|183024176|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.35|||<|0.0001|TWO_SIDED|90.0|0.2565|0.4441||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.4441|0.2565|<.0001
91567504|NCT03119688|183024176|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.427|||<|0.0001|TWO_SIDED|90.0|0.3333|0.5211||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.5211|0.3333|<.0001
91567505|NCT03119688|183024176|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.065||||0.2518|TWO_SIDED|90.0|-0.0287|0.1592||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.1592|-0.0287|0.2518
91567506|NCT01084239|183024205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|Result for index hospitalization||||||<0.001
91567507|NCT02705625|183024224|SUPERIORITY|"For the primary endpoint, the Type I error for the tests of the two doses was protected by performing a fixed-sequence multiple-testing procedure in the following order:~Step 1: 200 mg versus placebo Step 2: 100 mg versus placebo The second step was only considered as confirmatory provided the previous step was significant at a one-sided 5%-level (p\<0.05).~If the previous step was not significant, the analysis of the following step was considered descriptive."|Mean Difference (Final Values)|-0.0761||||0.4055|TWO_SIDED|95.0|-0.703|0.55||The p-values reported is from Step 1 (comparing 200 mg versus placebo). The corresponding p-value from Step 2 (comparing 100 mg versus placebo) was 0.1458.|Mixed Models Analysis|||A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment by time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline NRS was included as a covariate for adjustment. An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model.||0.55|-0.703|0.4055
91567508|NCT02705625|183024225|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-14.7||||0.0036|TWO_SIDED|95.0|-25.3|-4.02||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.02|-25.3|0.0036
91567509|NCT02705625|183024225|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-15.4||||0.0023|TWO_SIDED|95.0|-26.0|-4.83||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.83|-26|0.0023
91567510|NCT02705625|183024226|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0436||||0.1253|TWO_SIDED|95.0|-0.031|0.118||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.118|-0.031|0.1253
91567511|NCT02705625|183024226|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0761||||0.0225|TWO_SIDED|95.0|0.00173|0.15||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.15|0.00173|0.0225
91567512|NCT02705625|183024227|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-1.77||||0.2887|TWO_SIDED|95.0|-8.02|4.48||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time,baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.48|-8.02|0.2887
91567513|NCT02705625|183024227|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-4.55||||0.0753|TWO_SIDED|95.0|-10.8|1.67||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||1.67|-10.8|0.0753
91567514|NCT02705625|183024228|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-1.84||||0.2898|TWO_SIDED|95.0|-8.38|4.7||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.7|-8.38|0.2898
91567515|NCT02705625|183024228|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-3.78||||0.1262|TWO_SIDED|95.0|-10.3|2.72||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.72|-10.3|0.1262
91567516|NCT02705625|183024229|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-3.07||||0.2|TWO_SIDED|95.0|-10.2|4.1||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.1|-10.2|0.2
91567517|NCT02705625|183024229|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-4.95||||0.0861|TWO_SIDED|95.0|-12.1|2.17||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.17|-12.1|0.0861
91567518|NCT02705625|183024230|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.254|||<|0.0001|TWO_SIDED|95.0|-0.302|-0.206||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.206|-0.302|<0.0001
91567519|NCT02705625|183024230|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.145|||<|0.0001|TWO_SIDED|95.0|-0.193|-0.0983||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.0983|-0.193|<0.0001
91567520|NCT02705625|183024231|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-270.0|||<|0.0001|TWO_SIDED|95.0|-339.0|-201.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-201|-339|<0.0001
91567521|NCT02705625|183024231|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-193.0|||<|0.0001|TWO_SIDED|95.0|-262.0|-124.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by- time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-124|-262|<0.0001
91567522|NCT00863798|183024232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.175|TWO_SIDED|95.0|-0.38|2.1||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||2.10|-0.38|0.175
91567523|NCT00863798|183024232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.421|TWO_SIDED|95.0|-0.73|1.75||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||1.75|-0.73|0.421
91567524|NCT00863798|183024233|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.076
91567525|NCT00863798|183024233|SUPERIORITY_OR_OTHER|||||||0.204|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.204
91567526|NCT00863798|183024234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.13|TWO_SIDED|95.0|-0.04|0.35|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.35|-0.04|0.130
91567527|NCT00863798|183024234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.757|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-0.16|0.757
91567528|NCT00863798|183024235|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.41||||0.114|TWO_SIDED|95.0|-0.34|3.16|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.16|-0.34|0.114
91567529|NCT00863798|183024235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.316|TWO_SIDED|95.0|-0.85|2.64|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.64|-0.85|0.316
91567530|NCT00863798|183024236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.054|TWO_SIDED|95.0|-0.01|1.5|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.50|-0.01|0.054
91567531|NCT00863798|183024236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.253|TWO_SIDED|95.0|-0.32|1.2|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.20|-0.32|0.253
91567532|NCT00863798|183024237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.254||||0.2415|TWO_SIDED|95.0|0.86|1.83|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.83|0.86|0.2415
91567533|NCT00863798|183024237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.102||||0.6169|TWO_SIDED|95.0|0.75|1.61|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.61|0.75|0.6169
91567534|NCT00863798|183024238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.236||||0.3667|TWO_SIDED|95.0|0.78|1.96|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.96|0.78|0.3667
91567535|NCT00863798|183024238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.6509|TWO_SIDED|95.0|0.55|1.45|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.45|0.55|0.6509
91567536|NCT00863798|183024239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.3893|TWO_SIDED|95.0|0.81|1.73|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.73|0.81|0.3893
91567537|NCT00863798|183024239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.551|TWO_SIDED|95.0|0.77|1.65|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.65|0.77|0.5510
91567538|NCT00863798|183024240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.442||||0.0536|TWO_SIDED|95.0|0.99|2.09|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||2.09|0.99|0.0536
91567539|NCT00863798|183024240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.085||||0.6679|TWO_SIDED|95.0|0.75|1.57|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||1.57|0.75|0.6679
91567540|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.033|TWO_SIDED|95.0|0.12|2.79|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.79|0.12|0.033
91567541|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.096|TWO_SIDED|95.0|-0.2|2.49|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.49|-0.20|0.096
91567542|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||0.95|0.02|0.043
91567543|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.027|TWO_SIDED|95.0|0.06|1.0|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||1.00|0.06|0.027
91567544|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.045|TWO_SIDED|95.0|0.01|0.98|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.98|0.01|0.045
91567545|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.277|TWO_SIDED|95.0|-0.22|0.76|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.76|-0.22|0.277
91567546|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.056|TWO_SIDED|95.0|-0.01|0.91|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.91|-0.01|0.056
91567547|NCT00863798|183024242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.68|-0.24|0.355
91567548|NCT00863798|183024243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.53|-0.56|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||-0.56|-2.53|0.002
91567549|NCT00863798|183024243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.129|TWO_SIDED|95.0|-1.75|0.22|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.22|-1.75|0.129
91567550|NCT00863798|183024244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3097|TWO_SIDED|95.0|0.52|1.23|||Regression, Linear|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.23|0.52|0.3097
91567551|NCT00863798|183024244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.272||||0.2794|TWO_SIDED|95.0|0.82|1.97|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.97|0.82|0.2794
91567552|NCT00863798|183024246|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
91567553|NCT00863798|183024246|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.805
91567554|NCT00863798|183024246|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.978
91567555|NCT00863798|183024246|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Regression, Logistic|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
91567556|NCT00863798|183024246|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.154
91567557|NCT00863798|183024246|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.805
91567558|NCT01917006|183024293|SUPERIORITY||Least square mean difference|0.11||||0.393||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.|ANCOVA|||||||0.393
91567559|NCT01917006|183024293|SUPERIORITY||Least Square Mean Difference|0.25||||0.263||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.263
91567560|NCT01917006|183024293|SUPERIORITY||Least square mean difference|-0.39||||0.861||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.861
91567561|NCT01917006|183024293|SUPERIORITY||Least square mean difference|-0.14||||0.647||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.647
91567562|NCT01917006|183024293|SUPERIORITY||Least square mean difference|-0.13||||0.645||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.645
91567563|NCT01917006|183024293|SUPERIORITY||Least square mean difference|0.15||||0.343||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.343
91567564|NCT01917006|183024294|SUPERIORITY||Least square mean difference|55.33||||0.184||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2||||0.184
91567565|NCT01917006|183024294|SUPERIORITY||Least square mean difference|170.21||||0.002||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.002
91567566|NCT01917006|183024294|SUPERIORITY||Least square mean difference|12.73||||0.404||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.404
91567567|NCT01917006|183024294|SUPERIORITY||Least square mean difference|24.23||||0.328||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.328
91567568|NCT01917006|183024294|SUPERIORITY||Least square mean difference|18.48||||0.362||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.362
91567569|NCT01917006|183024294|SUPERIORITY||Least square mean difference|45.42||||0.203||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.203
91567570|NCT01917006|183024294|SUPERIORITY||Least square mean difference|33.05||||0.322||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.322
91567571|NCT01917006|183024294|SUPERIORITY||Least square mean difference|148.86||||0.015||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.015
91567572|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-6.2||||0.541||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.541
91567573|NCT01917006|183024294|SUPERIORITY||Least square mean difference|6.47||||0.459||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.459
91567574|NCT01917006|183024294|SUPERIORITY||Least square mean difference|1.32||||0.491||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.491
91567575|NCT01917006|183024294|SUPERIORITY||Least square mean difference|36.8||||0.281||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.281
91567576|NCT01917006|183024294|SUPERIORITY||Least square mean difference|14.12||||0.424||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.424
91567577|NCT01917006|183024294|SUPERIORITY||Least square mean difference|136.96||||0.026||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.026
91567578|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-27.62||||0.67||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.670
91567579|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-10.06||||0.561||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.561
91567580|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-16.58||||0.604||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.604
91567581|NCT01917006|183024294|SUPERIORITY||Least square mean difference|17.76||||0.394||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.394
91567582|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-5.94||||0.532||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.532
91567583|NCT01917006|183024294|SUPERIORITY||Least square mean difference|111.27||||0.058||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.058
91567584|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-48.65||||0.778||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.778
91567585|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-27.74||||0.662||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.662
91567586|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-35.72||||0.712||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.712
91567587|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-0.18||||0.501||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.501
91567588|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-12.14||||0.565||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.565
91567589|NCT01917006|183024294|SUPERIORITY||Least square mean difference|102.44||||0.071||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.071
91567590|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-52.81||||0.799||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.799
91567591|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-30.81||||0.681||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.681
91567592|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-40.68||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.741
91567593|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-4.33||||0.526||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.526
91567594|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-14.76||||0.584||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 12||||0.584
91567595|NCT01917006|183024294|SUPERIORITY||Least square mean difference|84.09||||0.101||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 12||||0.101
91567596|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-55.14||||0.823||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 12||||0.823
91567597|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-40.18||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 12||||0.741
91567598|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-41.31||||0.756||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 12||||0.756
91567599|NCT01917006|183024294|SUPERIORITY||Least square mean difference|-2.57||||0.517||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 12||||0.517
91567600|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.59||||0.079||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 2||||0.079
91567601|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.77||||0.025||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.025
91567602|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.07||||0.417||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.417
91567603|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.16||||0.33||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.330
91567604|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.3||||0.199||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.199
91567605|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.45||||0.113||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.113
91567606|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.5||||0.127||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.127
91567607|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.56||||0.087||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.087
91567608|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.04||||0.543||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.543
91567609|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.12||||0.377||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.377
91567610|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.17||||0.321||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.321
91567611|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.4||||0.149||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.149
91567612|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.35||||0.215||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.215
91567613|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.47||||0.126||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.126
91567614|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.28||||0.774||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.774
91567615|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.01||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.495
91567616|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.0||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.495
91567617|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.23||||0.274||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.274
91567618|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.22||||0.308||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.308
91567619|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.34||||0.205||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.205
91567620|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.39||||0.849||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.849
91567621|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.07||||0.571||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.571
91567622|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.09||||0.592||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.592
91567623|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.16||||0.34||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.340
91567624|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.16||||0.36||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.360
91567625|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.35||||0.192||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.192
91567626|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.37||||0.843||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.843
91567627|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.07||||0.572||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.572
91567628|NCT01917006|183024295|SUPERIORITY||Least square mean difference|-0.12||||0.628||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.628
91567629|NCT01917006|183024295|SUPERIORITY||Least square mean difference|0.12||||0.38||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.380
91567630|NCT03677245|183024324|OTHER|Wilcoxon signed ranks test used to compared pre-intervention to post-intervention means of the Pediatric Balance Scale. No power calculation performed or utilized.|Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91567631|NCT02509312|183024343|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
91567632|NCT02509312|183024344|SUPERIORITY|||||||0.257|||||||Chi-squared|||||||.257
91567633|NCT02509312|183024345|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
91567634|NCT02509312|183024346|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||||||0.164
91567635|NCT02509312|183024347|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91567636|NCT02509312|183024348|SUPERIORITY||Risk Difference (RD)|-0.27||||0.0367|TWO_SIDED|95.0|-0.52|-0.03|||Chi-squared|||||-0.03|-0.52|0.0367
91567637|NCT02509312|183024349|SUPERIORITY|||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||||||0.0231
91567638|NCT02509312|183024350|SUPERIORITY|||||||0.467|||||||Wilcoxon (Mann-Whitney)|||||||0.467
91567639|NCT02509312|183024351|SUPERIORITY|||||||0.273|||||||Wilcoxon (Mann-Whitney)|||||||0.273
91567640|NCT02509312|183024352|SUPERIORITY|||||||0.0162||||||p-value for 12 hours post-op between-group comparison.|t-test, 2 sided|||||||0.0162
91567641|NCT02509312|183024354|SUPERIORITY|||||||0.048||||||p-value for 6 hours post-op between-group comparison.|Wilcoxon (Mann-Whitney)|||||||0.048
91567642|NCT01850823|183024398|EQUIVALENCE|Equivalence based on Test/Reference Ratio and 90% confidence interval (as per OGD guidance)|Ratio Test/Reference LS Mean|114.723|||||TWO_SIDED|90.0|99.077|134.286||||||Conducted on Per Protocol Population||134.286|99.077|
91567643|NCT01850823|183024399|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||<0.0001
91567644|NCT01850823|183024399|SUPERIORITY|||||||0.0002|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||0.0002
91567645|NCT03247738|183024458|SUPERIORITY|The primary end point of our study was the comparison of platelet reactivity measured by VerifyNow PRU between cangrelor and placebo at 30 minutes after drugs were administered at the start of PCI. Assuming a common standard deviation of 70 PRU, a sample size of 20 patients per group would allow detection of a 70 PRU difference between groups with 85% power and a two-sided α = 0.05. Considering the 2 arms and a possible 25% rate of invalid PD results we planned to randomize up to 50 patients.|Mean Difference (Net)|152.0|||<|0.001|TWO_SIDED|95.0|108.0|195.0|||ANCOVA|the baseline value of platelet reactivity used as a covariate||||195|108|<0.001
91567646|NCT00413634|183024490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||ANOVA|||||||0.092
91567647|NCT00413634|183024493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.857||95.0|||||ANOVA|||||||0.857
91567648|NCT00413634|183024494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
91567649|NCT00413634|183024495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378||95.0|||||ANOVA|||||||0.378
91567650|NCT00413634|183024496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
91567651|NCT00413634|183024497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANOVA|||||||0.035
91567652|NCT00413634|183024498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0|||||ANOVA|||||||0.023
91567653|NCT00413634|183024499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||ANOVA|||||||0.557
91567654|NCT00413634|183024500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
91567655|NCT00413634|183024501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANOVA|||||||0.007
91567656|NCT00413634|183024502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
91567657|NCT00413634|183024503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0|||||ANOVA|||||||0.011
91567658|NCT00527514|183024512|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
91567659|NCT00527514|183024513|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||Statistical analysis parameters apply to both the daytime and nighttime rows.||||<0.0001
91567660|NCT00527514|183024514|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
91567661|NCT00527514|183024515|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
91567662|NCT00527514|183024516|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
91567663|NCT00527514|183024517|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
91567664|NCT04148521|183024518|SUPERIORITY||Odds Ratio (OR)|1.15||||0.27|TWO_SIDED|95.0|0.9|1.47|||Mixed Models Analysis|||||1.47|0.90|0.27
91567665|NCT04148521|183024519|SUPERIORITY||Odds Ratio (OR)|1.04||||0.83|TWO_SIDED|95.0|0.75|1.43|||Mixed Models Analysis|||||1.43|0.75|0.83
91567666|NCT04148521|183024520|SUPERIORITY||Odds Ratio (OR)|1.43||||0.12|TWO_SIDED|95.0|0.91|2.26|||Mixed Models Analysis|||||2.26|0.91|0.12
91567667|NCT04148521|183024521|SUPERIORITY||Odds Ratio (OR)|1.17||||0.51|TWO_SIDED|95.0|0.73|1.86|||Mixed Models Analysis|||||1.86|0.73|0.51
91567668|NCT02287883|183024527|OTHER|Clustered two-sample t-test||||||0.8|||||||t-test, 2 sided|||||||0.80
91567669|NCT02287883|183024528|OTHER|Clustered two-sample t-test||||||0.48|||||||t-test, 2 sided|||||||0.48
91567670|NCT02287883|183024529|OTHER|Clustered two-sample t-test||||||0.05|||||||t-test, 2 sided|||||||0.05
91567671|NCT04414397|183024530|SUPERIORITY||Rate Difference|66.9|||<|0.0001|TWO_SIDED|95.0|54.9|78.8||Analysis was performed using the SAS procedure MIANALYZE with normal approximation to generate an associated p-value for the comparison of responder rates between groups.|Multiple imputation regression|||JUVÉDERM® VOLUMA® XC Treatment vs No-treatment control||78.8|54.9|<0.0001
91567672|NCT04414397|183024534|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 visit is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
91567673|NCT04414397|183024535|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
91567674|NCT01387815|183024575|OTHER||||||<|0.001|||||||Chi-squared|||Comparison does not include missing.||||<0.001
91567675|NCT01387815|183024576|OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
91567676|NCT01387815|183024577|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91567677|NCT01387815|183024578|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91567678|NCT01387815|183024579|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91567679|NCT01387815|183024580|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91567680|NCT01387815|183024581|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91567681|NCT01387815|183024582|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
91567682|NCT01387815|183024583|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.060
91567683|NCT01387815|183024584|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
91567684|NCT01387815|183024585|OTHER|||||||0.755|||||||t-test, 2 sided|||||||0.755
91567685|NCT01387815|183024586|OTHER|||||||0.091|||||||t-test, 2 sided|||||||0.091
91567686|NCT01387815|183024587|OTHER|||||||0.106|||||||t-test, 2 sided|||||||0.106
91567687|NCT01387815|183024588|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91567688|NCT01387815|183024589|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
91567689|NCT01387815|183024590|OTHER|||||||0.083|||||||t-test, 2 sided|||||||0.083
91567690|NCT01387815|183024591|OTHER|||||||0.495|||||||t-test, 2 sided|||||||0.495
91567691|NCT01387815|183024592|OTHER|||||||0.097|||||||t-test, 2 sided|||||||0.097
91567692|NCT01387815|183024593|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
91567693|NCT01387815|183024594|OTHER|||||||0.037|||||||t-test, 2 sided|||||||0.037
91567694|NCT01387815|183024595|OTHER|||||||0.084|||||||t-test, 2 sided|||||||0.084
91567695|NCT01387815|183024596|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.090
91567696|NCT01387815|183024597|OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
91567697|NCT01387815|183024598|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
91567698|NCT01387815|183024599|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
91567699|NCT01387815|183024600|OTHER|||||||0.002|||||||Log Rank|||||||0.002
91567700|NCT01387815|183024601|OTHER|||||||0.002|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.002
91567701|NCT01387815|183024602|OTHER|"Comparison does not include the Missing category."||||||0.017|||||||Chi-squared|||||||0.017
91567702|NCT01387815|183024603|OTHER|||||||0.01||||||"Comparison does not include the Missing category."|Chi-squared|||||||0.010
91567703|NCT01387815|183024604|OTHER|||||||0.015|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.015
91567704|NCT01387815|183024605|OTHER|||||||0.06|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.060
91567705|NCT01387815|183024606|OTHER|||||||0.501|||||||t-test, 2 sided|||||||0.501
91567706|NCT01387815|183024607|OTHER|||||||0.807|||||||t-test, 2 sided|||||||0.807
91567707|NCT01387815|183024608|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
91567708|NCT01387815|183024609|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
91567709|NCT01387815|183024610|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
91567710|NCT01387815|183024611|OTHER|||||||0.367|||||||t-test, 2 sided|||||||0.367
91567711|NCT01387815|183024612|OTHER|||||||0.521|||||||t-test, 2 sided|||||||0.521
91567712|NCT01387815|183024613|OTHER|||||||0.793|||||||t-test, 2 sided|||||||0.793
91567713|NCT01387815|183024614|OTHER|||||||0.442|||||||t-test, 2 sided|||||||0.442
91567714|NCT01387815|183024615|OTHER|||||||0.434|||||||t-test, 2 sided|||||||0.434
91567715|NCT01387815|183024616|OTHER|||||||0.752|||||||t-test, 2 sided|||||||0.752
91567716|NCT01387815|183024617|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
91567717|NCT01387815|183024618|OTHER|||||||0.419|||||||t-test, 2 sided|||||||0.419
91567718|NCT01387815|183024619|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
91567719|NCT01387815|183024620|OTHER|||||||0.452|||||||t-test, 2 sided|||||||0.452
91567720|NCT01387815|183024621|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
91567721|NCT01387815|183024622|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
91567722|NCT01387815|183024623|OTHER|||||||0.252|||||||t-test, 2 sided|||||||0.252
91567723|NCT01387815|183024627|OTHER|||||||0.143|||||||Chi-squared|||||||0.143
91567724|NCT01387815|183024628|OTHER|||||||0.415|||||||Chi-squared|||||||0.415
91567725|NCT01387815|183024629|OTHER|||||||0.604|||||||Chi-squared|||||||0.604
91567726|NCT01387815|183024630|OTHER|||||||0.504|||||||Fisher Exact|||||||0.504
91567727|NCT01387815|183024631|OTHER|||||||0.92|||||||Chi-squared|||||||0.920
91567728|NCT01387815|183024632|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91567729|NCT01387815|183024633|OTHER|||||||0.575|||||||Chi-squared|||||||0.575
91567730|NCT01387815|183024636|OTHER|||||||0.856|||||||Chi-squared|||||||0.856
91567731|NCT01387815|183024637|OTHER|||||||0.623|||||||Chi-squared|||||||0.623
91567732|NCT01387815|183024638|OTHER|||||||0.732|||||||Chi-squared|||||||0.732
91567733|NCT01387815|183024639|OTHER|||||||0.896|||||||t-test, 2 sided|||||||0.896
91567734|NCT01387815|183024640|OTHER|||||||0.879|||||||t-test, 2 sided|||||||0.879
91567735|NCT01387815|183024641|OTHER|||||||0.763|||||||t-test, 2 sided|||||||0.763
91567736|NCT01387815|183024642|OTHER|||||||0.657|||||||Chi-squared|||||||0.657
91567737|NCT01387815|183024643|OTHER|||||||0.987|||||||Chi-squared|||||||0.987
91567738|NCT01387815|183024644|OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
91567739|NCT01387815|183024645|OTHER|||||||0.351|||||||t-test, 2 sided|||||||0.351
91567740|NCT01387815|183024646|OTHER|||||||0.835|||||||t-test, 2 sided|||||||0.835
91567741|NCT01387815|183024648|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
91567742|NCT01387815|183024649|OTHER|||||||0.737|||||||Fisher Exact|||||||0.737
91567743|NCT01387815|183024650|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91567744|NCT01387815|183024654|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91567745|NCT01387815|183024655|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91567746|NCT01387815|183024657|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
91567747|NCT01387815|183024658|OTHER|||||||0.747|||||||Fisher Exact|||||||0.747
91567748|NCT01387815|183024659|OTHER|||||||0.495|||||||Fisher Exact|||||||0.495
91567749|NCT01387815|183024663|OTHER|||||||0.364|||||||Fisher Exact|||||||0.364
91567750|NCT01387815|183024664|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
91567751|NCT01387815|183024665|OTHER|||||||0.723|||||||Fisher Exact|||||||0.723
91567752|NCT01387815|183024672|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
91567753|NCT01387815|183024673|OTHER|||||||0.672|||||||t-test, 2 sided|||||||0.672
91567754|NCT01387815|183024674|OTHER|||||||0.482|||||||t-test, 2 sided|||||||0.482
91567755|NCT01387815|183024675|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
91567756|NCT01387815|183024676|OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
91567757|NCT01387815|183024677|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
91567758|NCT01387815|183024678|OTHER|||||||0.808|||||||t-test, 2 sided|||||||0.808
91567759|NCT01387815|183024679|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
91567760|NCT01387815|183024680|OTHER|||||||0.184|||||||t-test, 2 sided|||||||0.184
91567761|NCT01387815|183024681|OTHER|||||||0.305|||||||t-test, 2 sided|||||||0.305
91567762|NCT01387815|183024683|OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
91567763|NCT01387815|183024684|OTHER|||||||0.321|||||||t-test, 2 sided|||||||0.321
91567764|NCT01387815|183024685|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
91567765|NCT01387815|183024686|OTHER|||||||0.395|||||||t-test, 2 sided|||||||0.395
91567766|NCT01387815|183024688|OTHER|||||||0.739|||||||t-test, 2 sided|||||||0.739
91567767|NCT01387815|183024689|OTHER|||||||0.291|||||||t-test, 2 sided|||||||0.291
91567768|NCT01649297|183024729|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.16|0.13||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.13|-0.16|<0.0001
91567769|NCT01649297|183024729|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.26|0.03||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.03|-0.26|<0.0001
91567770|NCT01649297|183024729|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.79|-0.44|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.44|-0.79|<0.0001
91567771|NCT01649297|183024729|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.68|-0.32|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.32|-0.68|<0.0001
91567772|NCT01649297|183024729|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.62|-0.27|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.27|-0.62|<0.0001
91567773|NCT01649297|183024729|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.25|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.25|-0.60|<0.0001
91567774|NCT01649297|183024730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-9.0|1.8|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||1.8|-9.0|
91567775|NCT01649297|183024730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-10.4|0.5||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||0.5|-10.4|
91567776|NCT01649297|183024730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-34.2|-20.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-20.9|-34.2|<0.0001
91567777|NCT01649297|183024730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-29.2|-15.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-15.9|-29.2|<0.0001
91567778|NCT01649297|183024730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.1|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.7|-14.4|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-14.4|-27.7|<0.0001
91567779|NCT01649297|183024730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-24.1|-10.8|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-10.8|-24.1|<0.0001
91567780|NCT01685047|183024731|OTHER|There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.|||||<|0.05||||||All events with p \<0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.|t-test, 2 sided|||There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.||||<0.05
91567781|NCT02847637|183024740|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.02|0.075||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.075|0.020|<0.0001
91567782|NCT02847637|183024740|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.017|0.066||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.066|0.017|<0.0001
91567783|NCT02847637|183024741|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.099||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.099|0.028|<0.0001
91567784|NCT02847637|183024741|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.103||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.103|0.030|<0.0001
91567785|NCT02847637|183024742|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.019|0.085||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.085|0.019|<0.0001
91567786|NCT02847637|183024742|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.015|0.07||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.070|0.015|<0.0001
91567787|NCT02847637|183024743|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.025|0.151||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.151|0.025|<0.0001
91567788|NCT02847637|183024743|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.056||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.056|0.006|<0.0001
91567789|NCT02847637|183024744|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.143||Not controlled for type I error|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.143|0.016|<0.0001
91567790|NCT02847637|183024744|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.018|0.147||Not controlled for type I error|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.147|0.018|<0.0001
91567791|NCT02847637|183024745|SUPERIORITY||ABR Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.195|0.514||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.514|0.195|<0.0001
91567792|NCT02847637|183024746|SUPERIORITY||ABR Ratio|0.37||||0.0002|TWO_SIDED|95.0|0.22|0.626||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.626|0.220|0.0002
91567793|NCT02847637|183024747|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.014|0.067||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.067|0.014|<0.0001
91567794|NCT02847637|183024748|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.023|0.068||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.068|0.023|<0.0001
91567795|NCT02847637|183024749|SUPERIORITY||Mean Difference (Final Values)|12.51||||0.0891|TWO_SIDED|95.0|-1.96|26.98||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||26.98|-1.96|0.0891
91567796|NCT02847637|183024749|SUPERIORITY||Mean Difference (Final Values)|15.97||||0.0349|TWO_SIDED|95.0|1.16|30.78||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||30.78|1.16|0.0349
91567797|NCT02847637|183024750|SUPERIORITY||Mean Difference (Final Values)|5.91||||0.1269|TWO_SIDED|95.0|-1.72|13.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||13.55|-1.72|0.1269
91567798|NCT02847637|183024750|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0317|TWO_SIDED|95.0|0.77|16.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||16.35|0.77|0.0317
91567799|NCT02847637|183024751|SUPERIORITY||Mean Difference (Final Values)|-4.04||||0.3402|TWO_SIDED|95.0|-12.43|4.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||4.35|-12.43|0.3402
91567800|NCT02847637|183024751|SUPERIORITY||Mean Difference (Final Values)|-9.15||||0.0373|TWO_SIDED|95.0|-17.74|-0.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.55|-17.74|0.0373
91567801|NCT02847637|183024752|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.006|TWO_SIDED|95.0|-0.22|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||-0.04|-0.22|0.0060
91567802|NCT02847637|183024752|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.0059|TWO_SIDED|95.0|-0.23|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.04|-0.23|0.0059
91567803|NCT03036150|183024796|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001||95.0|0.51|0.72|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.72|0.51|< 0.0001
91567804|NCT03036150|183024797|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.45|0.68|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.68|0.45|< 0.0001
91567805|NCT03036150|183024798|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0089||95.0|0.55|0.92|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.92|0.55|0.0089
91567806|NCT03036150|183024799|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0035||95.0|0.53|0.88|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.88|0.53|0.0035
91567807|NCT01318538|183024801|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED|95.0|||||loglinear (negative binomial) regression|Analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (relative changes i.e. % change)||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).||||0.821
91567808|NCT01318538|183024802|SUPERIORITY_OR_OTHER|||||||0.519|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).||||0.519
91567809|NCT01318538|183024803|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.253
91567810|NCT01318538|183024804|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.667
91567811|NCT01318538|183024806|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91567812|NCT01318538|183024807|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91567813|NCT01318538|183024808|SUPERIORITY_OR_OTHER|||||||0.464|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p\<0.05) but not for GDC (1.5 day reduction; p\>0.01).||||0.464
91567814|NCT01318538|183024809|SUPERIORITY_OR_OTHER|||||||0.904|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).||||0.904
91567815|NCT01318538|183024810|SUPERIORITY_OR_OTHER|||||||0.799|||||||linear mixed effect model|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p\<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).||||0.799
91567816|NCT00496626|183024816|SUPERIORITY_OR_OTHER||GMT ratio|101.6|||<=|0.05|TWO_SIDED|95.0|88.1|117.2||The ANCOVA models showed the lower bounds of two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] were greater than 1 for each HPV type, so the null hypothesis was rejected. The CI reported is for HPV18, the type with the smallest CI lower bound.|ANCOVA||Superiority of GARDASIL™ to placebo was claimed if, for each of the four HPV types, the lower bound of the two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] being \>1, or equivalently, the two-sided p-value \<0.05.|An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.||117.2|88.1|<=0.05
91567817|NCT00496626|183024817|SUPERIORITY_OR_OTHER||Seroconversion Rate|96.65|||<=|0.05||95.0|93.74|98.46||The lower bound of the 95% CI for the seroconversion rate was greater than 90% for each type so the null hypothesis was rejected. The CI reported is for HPV6, the type with the smallest lower bound.|Exact Binomial CI|||The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.||98.46|93.74|<=0.05
91567818|NCT00570921|183024819|SUPERIORITY_OR_OTHER||Median Time to Progression|7.4|||||TWO_SIDED|95.0|1.9|12.1||||||We hypothesized that median time to progression (TTP) in our trial will increase from 3.7 months for the historical fulvestrant-only control to 7.0 months on the combination of fulvestrant and everolimus in the current trial. A sample of 40 evaluable patients was calculated to show the increase in TTP with 80% power and 5% significance level based on a two sided test of differences in survival times between historical controls and treated group.||12.1|1.9|
91567819|NCT00570921|183024820|SUPERIORITY_OR_OTHER||Response Rate Percentage|12.9|||||TWO_SIDED|95.0|3.63|29.83|||||Percentage of Patients with a complete or partial response with 95% exact binomial proportion confidence interval|||29.83|3.63|
91567820|NCT00570921|183024821|SUPERIORITY_OR_OTHER||Percentage with clinical benefit|48.39|||||TWO_SIDED|95.0|30.15|66.94|||||Percentage of patients that had a complete response, partial response, or stable disease for 24 weeks or more as defined by RECIST v1.0.|||66.94|30.15|
91567821|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-0.791||||0.0002|TWO_SIDED|95.0|-1.203|-0.378|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.378|-1.203|0.0002
91567822|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-0.851|||<|0.0001|TWO_SIDED|95.0|-1.263|-0.439|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.439|-1.263|<.0001
91567823|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-1.545|||<|0.0001|TWO_SIDED|95.0|-1.954|-1.135|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-1.135|-1.954|<.0001
91567824|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-1.208|||<|0.0001|TWO_SIDED|95.0|-1.639|-0.778|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.778|-1.639|<.0001
91567825|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-1.245|||<|0.0001|TWO_SIDED|95.0|-1.679|-0.811|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.811|-1.679|<.0001
91567826|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-1.846|||<|0.0001|TWO_SIDED|95.0|-2.273|-1.418|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-1.418|-2.273|<.0001
91567827|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-1.696|||<|0.0001|TWO_SIDED|95.0|-2.08|-1.312|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.312|-2.080|<.0001
91567828|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-1.617|||<|0.0001|TWO_SIDED|95.0|-2.001|-1.232|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.232|-2.001|<.0001
91567829|NCT03231969|183024859|SUPERIORITY||Mean Difference (Final Values)|-2.009|||<|0.0001|TWO_SIDED|95.0|-2.387|-1.63|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.630|-2.387|<.0001
91567830|NCT01670188|183024916|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
91567831|NCT00241969|183024917|SUPERIORITY|Some data were missing for energy intake (n=3 baseline, n=13 post-treatment), thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measure factor.|maximum likelihood estimation|431.0|||<|0.001|TWO_SIDED|95.0|282.0|581.0|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Some data were missing for energy intake (N = 3 baseline; 13 post treatment), and thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measures factor, no group main effect at baseline for energy intake, and sex, baseline Pseudomonas aeruginosa status, and treatment modality as covariates in the statistical model. This model is similar to an analysis of covariance model with baseline energy intake included as an additional covariate, but the PROC MIXED model employs maximum likelihood estimation and consequently allows for data to be missing at random. The test of the time by group interaction within this PROC MIXED model indicated whether the behavioral and nutrition treatment was efficacious relative to our control treatment.|581|282|<0.001
91567832|NCT00241969|183024918|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.09||||0.25|TWO_SIDED|95.0|-0.06|0.24|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.24|-0.06|0.25
91567833|NCT00241969|183024919|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.14||||0.049|TWO_SIDED|95.0|0.001|0.27|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ and HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.27|0.001|0.049
91567834|NCT00874497|183024957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0824||||0.1761|TWO_SIDED|95.0|-0.0378|0.2025||P-values are based on Analysis of Covariance (ANCOVA) model of the change FEV1 from baseline to the specified study week using treatment group and current smoking status as fixed effects and the baseline FEV1 value as a covariate.|ANCOVA|||Statistical analysis at Week 104.||0.2025|-0.0378|0.1761
91567835|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.904||||0.139|TWO_SIDED|95.0|-6.77|0.97|||ANCOVA|||Statistical analysis of Right Upper region of the lung at Week 104.||0.97|-6.77|0.139
91567836|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.46|TWO_SIDED|95.0|-4.46|2.04|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||2.04|-4.46|0.460
91567837|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.176||||0.457|TWO_SIDED|95.0|-7.98|3.63|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||3.63|-7.98|0.457
91567838|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.167||||0.362|TWO_SIDED|95.0|-6.88|2.54|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||2.54|-6.88|0.362
91567839|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.225||||0.67|TWO_SIDED|95.0|-6.94|4.48|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||4.48|-6.94|0.670
91567840|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.218||||0.244|TWO_SIDED|95.0|-5.98|1.55|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||1.55|-5.98|0.244
91567841|NCT00874497|183024958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.374||||0.574|TWO_SIDED|95.0|-6.23|3.48|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||3.48|-6.23|0.574
91567842|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.436|TWO_SIDED|95.0|-1.53|3.47|||ANCOVA|||Statistical analysis of Right Upper region of the Lung at Week 104.||3.47|-1.53|0.436
91567843|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.067|TWO_SIDED|95.0|-0.17|4.79|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||4.79|-0.17|0.067
91567844|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97||||0.163|TWO_SIDED|95.0|-0.83|4.77|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||4.77|-0.83|0.163
91567845|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.102|TWO_SIDED|95.0|-0.48|5.02|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||5.02|-0.48|0.102
91567846|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11||||0.162|TWO_SIDED|95.0|-0.89|5.12|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||5.12|-0.89|0.162
91567847|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.16|TWO_SIDED|95.0|-0.73|4.29|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||4.29|-0.73|0.160
91567848|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.08||||0.122|TWO_SIDED|95.0|-0.58|4.75|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||4.75|-0.58|0.122
91567849|NCT00874497|183024960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05||||0.106|TWO_SIDED|95.0|-0.46|4.56|||ANCOVA|||Statistical analysis of Whole Lung region of the Lung at Week 104.||4.56|-0.46|0.106
91567850|NCT00874497|183024961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.423||||0.469|TWO_SIDED|95.0|-5.32|2.48|||ANCOVA|||LS Mean Difference between Tetomilast and Placebo at Week 104.||2.48|-5.32|0.469
91567851|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.519|TWO_SIDED|95.0|-4.42|2.27|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||2.27|-4.42|0.519
91567852|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.463|TWO_SIDED|95.0|-3.92|1.82|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104.||1.82|-3.92|0.463
91567853|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.598|TWO_SIDED|95.0|-6.74|3.94|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104.||3.94|-6.74|0.598
91567854|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.142|TWO_SIDED|95.0|-6.92|1.03|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||1.03|-6.92|0.142
91567855|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.757|TWO_SIDED|95.0|-6.26|4.59|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||4.59|-6.26|0.757
91567856|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.5|TWO_SIDED|95.0|-5.03|2.5|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||2.50|-5.03|0.500
91567857|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.353|TWO_SIDED|95.0|-6.09|2.23|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||2.23|-6.09|0.353
91567858|NCT00874497|183024962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.438|TWO_SIDED|95.0|-5.43|2.4|||ANCOVA|||Statistical analysis of whole region of the lung at Week 104.||2.40|-5.43|0.438
91567859|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|351487.0||||0.22|TWO_SIDED|95.0|-219976.0|922951.0|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||922951|-219976|0.220
91567860|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|103036.0||||0.146|TWO_SIDED|95.0|-37651.0|243723.0|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104||243723|-37651|0.146
91567861|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|247358.0||||0.322|TWO_SIDED|95.0|-252728.0|747444.0|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104||747444|-252728|0.322
91567862|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|362384.0||||0.141|TWO_SIDED|95.0|-126518.0|851286.0|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||851286|-126518|0.141
91567863|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|294202.0||||0.325|TWO_SIDED|95.0|-303329.0|891733.0|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||891733|-303329|0.325
91567864|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|575882.0||||0.258|TWO_SIDED|95.0|-439692.0|1591457.0|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||1591457|-439692|0.258
91567865|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|589373.0||||0.247|TWO_SIDED|95.0|-426928.0|1605673.0|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||1605673|-426928|0.247
91567866|NCT00874497|183024963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1156318.0||||0.251|TWO_SIDED|95.0|-855009.0|3167645.0|||ANCOVA|||Statistical analysis of whole lung region of the lung at Week 104.||3167645|-855009|0.251
91567867|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.9||||0.181|TWO_SIDED|95.0|-38.0|193.8|||ANCOVA|||Statistical analysis of right upper lung region (RV) at Week 104.||193.8|-38.0|0.181
91567868|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.781|TWO_SIDED|95.0|-48.8|36.9|||ANCOVA|||Statistical analysis of right middle lung region (RV) at Week 104.||36.9|-48.8|0.781
91567869|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.7||||0.445|TWO_SIDED|95.0|-77.8|173.2|||ANCOVA|||Statistical analysis of right lower lung region (RV) at Week 104.||173.2|-77.8|0.445
91567870|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.6||||0.259|TWO_SIDED|95.0|-48.1|173.2|||ANCOVA|||Statistical analysis of left upper lung region (RV) at Week 104.||173.2|-48.1|0.259
91567871|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.639|TWO_SIDED|95.0|-105.6|169.6|||ANCOVA|||Statistical analysis of left lower lung region (RV) at Week 104.||169.6|-105.6|0.639
91567872|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.3||||0.408|TWO_SIDED|95.0|-145.9|350.5|||ANCOVA|||Statistical analysis of right whole lung region (RV) at Week 104.||350.5|-145.9|0.408
91567873|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.2||||0.445|TWO_SIDED|95.0|-138.8|309.2|||ANCOVA|||Statistical analysis of left whole lung region (RV) at Week 104.||309.2|-138.8|0.445
91567874|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|187.6||||0.421|TWO_SIDED|95.0|-279.6|654.8|||ANCOVA|||Statistical analysis of whole lung region (RV) at Week 104.||654.8|-279.6|0.421
91567875|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7||||0.353|TWO_SIDED|95.0|-58.5|159.9|||ANCOVA|||Statistical analysis of right upper lung region (TLC) at Week 104.||159.9|-58.5|0.353
91567876|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.66|TWO_SIDED|95.0|-35.3|55.0|||ANCOVA|||Statistical analysis of right middle lung region (TLC) at Week 104.||55.0|-35.3|0.660
91567877|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7||||0.859|TWO_SIDED|95.0|-110.7|132.1|||ANCOVA|||Statistical analysis of right lower lung region (TLC) at Week 104.||132.1|-110.7|0.859
91567878|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.5||||0.253|TWO_SIDED|95.0|-38.4|141.4|||ANCOVA|||Statistical analysis of left upper lung region (TLC)at Week 104.||141.4|-38.4|0.253
91567879|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.3||||0.754|TWO_SIDED|95.0|-126.0|172.6|||ANCOVA|||Statistical analysis of left lower lung region (TLC) at Week 104.||172.6|-126.0|0.754
91567880|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.2||||0.546|TWO_SIDED|95.0|-145.1|269.5|||ANCOVA|||Statistical analysis of right whole lung region (TLC) at Week 104.||269.5|-145.1|0.546
91567881|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.9||||0.554|TWO_SIDED|95.0|-155.5|285.3|||ANCOVA|||Statistical analysis of left whole lung region (TLC) at Week 104.||285.3|-155.5|0.554
91567882|NCT00874497|183024964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.2||||0.524|TWO_SIDED|95.0|-284.9|549.4|||ANCOVA|||Statistical analysis of whole lung region (TLC) at Week 104.||549.4|-284.9|0.524
91567883|NCT00874497|183024965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5843|TWO_SIDED|95.0|-0.07|0.04|||ANCOVA|||||0.04|-0.07|0.5843
91567884|NCT00874497|183024966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249||||0.1252|TWO_SIDED|95.0|-0.073|0.571|||ANCOVA|||||0.571|-0.073|0.1252
91567885|NCT00874497|183024967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1835||||0.4661|TWO_SIDED|95.0|-0.6892|0.3221|||ANCOVA|||||0.3221|-0.6892|0.4661
91567886|NCT00874497|183024968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.134|TWO_SIDED|95.0|-0.19|1.4|||ANCOVA|||||1.40|-0.19|0.134
91567887|NCT00874497|183024969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.074|TWO_SIDED|95.0|-1.5|0.07|||ANCOVA|||Statistical analysis for sRaw||0.07|-1.50|0.074
91567888|NCT00874497|183024969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.155|TWO_SIDED|95.0|-0.09|0.52|||ANCOVA|||Statistical analysis for sGaw||0.52|-0.09|0.155
91567889|NCT00874497|183024970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.845|TWO_SIDED|95.0|-0.77|0.64|||ANCOVA|||Statistical analysis for mean prior daily breath symptoms||0.64|-0.77|0.845
91567890|NCT00874497|183024970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.549|TWO_SIDED|95.0|-0.52|0.94|||ANCOVA|||Statistical analysis for mean prior daily cough symptoms||0.94|-0.52|0.549
91567891|NCT00874497|183024970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.717|TWO_SIDED|95.0|-0.93|0.65|||ANCOVA|||Statistical analysis for mean prior daily sputum symptoms||0.65|-0.93|0.717
91567892|NCT00874497|183024972|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level I (self management) at week 104.||||1.000
91567893|NCT00874497|183024972|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level II (physician visit) at week 104.||||1.0000
91567894|NCT00874497|183024972|SUPERIORITY_OR_OTHER|||||||0.5092|||||||Fisher Exact|||Statistical analysis for level III (hospital visit) at week 104.||||0.5092
91567895|NCT00874497|183024973|SUPERIORITY_OR_OTHER|||||||0.63||||||Fisher's Exact test was used to determine whether the tetomilast and placebo groups differ in the proportion of participants who experienced Level 2 or higher COPD exacerbations during the study.|Fisher Exact|||Statistical analysis at Week 104||||0.630
91567896|NCT01013740|183024979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||||95.0|0.53|1.35|||||The Pike estimator of the treatment HR was based on the log rank test.|||1.35|0.53|
91567897|NCT01013740|183024984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.63|3.58||||||||3.58|0.63|
91567898|NCT00510146|183025045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.018|TWO_SIDED|95.0|-3.93|-0.36||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in MADRS total score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.36|-3.93|0.018
91567899|NCT00510146|183025046|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic response at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.050
91567900|NCT00510146|183025047|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic remission at any time from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.367
91567901|NCT00510146|183025048|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.11||||0.008|TWO_SIDED|95.0|-0.2|-0.03||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Mania score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.03|-0.20|0.008
91567902|NCT00510146|183025048|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24||||0.037|TWO_SIDED|95.0|-0.47|-0.01||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.01|-0.47|0.037
91567903|NCT00510146|183025048|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.008|TWO_SIDED|95.0|-0.53|-0.08||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.08|-0.53|0.008
91567904|NCT00510146|183025049|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with recovery from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.156
91567905|NCT00510146|183025050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.56|-0.43||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.43|-1.56|<0.001
91567906|NCT00510146|183025051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.002|TWO_SIDED|95.0|-3.61|-0.81||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.81|-3.61|0.002
91567907|NCT00510146|183025052|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.297
91567908|NCT00510146|183025052|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.264
91567909|NCT00510146|183025053|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current hypomanic episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.195
91567910|NCT00510146|183025054|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current psychotic disorders from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.163
91567911|NCT00510146|183025054|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.442
91567912|NCT00510146|183025055|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol dependence from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||1.00
91567913|NCT00510146|183025055|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.324
91567914|NCT00510146|183025057|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with emergence of mania at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.031
91567915|NCT00510146|183025058|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (akathisia) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.269
91567916|NCT00510146|183025058|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.736
91567917|NCT00510146|183025059|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
91567918|NCT00510146|183025059|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.249
91567919|NCT00510146|183025059|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
91567920|NCT00510146|183025059|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.271
91567921|NCT00510146|183025059|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.284
91567922|NCT00510146|183025059|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.067
91567923|NCT00510146|183025060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in weight from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
91567924|NCT00510146|183025061|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in fasting glucose from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.179
91567925|NCT00510146|183025061|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
91567926|NCT00510146|183025061|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.003
91567927|NCT00510146|183025061|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
91567928|NCT00510146|183025061|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.095
91567929|NCT00510146|183025062|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in albumin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
91567930|NCT00510146|183025063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in ALT/SGPT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567931|NCT00510146|183025063|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
91567932|NCT00510146|183025063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567933|NCT00510146|183025064|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in direct bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567934|NCT00510146|183025064|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567935|NCT00510146|183025064|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567936|NCT00510146|183025065|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in erythrocyte count from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.003
91567937|NCT00510146|183025066|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hematocrit from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
91567938|NCT00510146|183025067|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin A1c from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.009
91567939|NCT00510146|183025068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567940|NCT00510146|183025069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in prolactin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567941|NCT00510146|183025070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in urinalysis-specific gravity from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567942|NCT00510146|183025071|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcF interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.104
91567943|NCT00510146|183025071|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.006
91567944|NCT00510146|183025072|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in heart rate from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.035
91567945|NCT00510146|183025073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.943|TWO_SIDED|95.0|-0.59|0.64||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint for MINI Suicidality Total Score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||0.64|-0.59|0.943
91567946|NCT00510146|183025081|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents change from baseline to endpoint-standing diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.736
91567947|NCT00510146|183025081|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.944
91567948|NCT00510146|183025081|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.080
91567949|NCT00510146|183025081|SUPERIORITY_OR_OTHER|||||||0.612||95.0||||p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.612
91567950|NCT00510146|183025081|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.640
91567951|NCT00510146|183025081|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.122
91567952|NCT00510146|183025082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for weight from t-tests on change.|t-test, 2 sided|||||||<0.001
91567953|NCT00510146|183025083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for albumin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567954|NCT00510146|183025083|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
91567955|NCT00510146|183025084|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for alkaline phosphatase from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
91567956|NCT00510146|183025084|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
91567957|NCT00510146|183025084|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.354
91567958|NCT00510146|183025085|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for chlorine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
91567959|NCT00510146|183025086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for creatinine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567960|NCT00510146|183025087|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p-value represents change from baseline to endpoint for erythrocyte count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.021
91567961|NCT00510146|183025088|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents change from baseline to endpoint for hemoglobin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.035
91567962|NCT00510146|183025089|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value represents change from baseline to endpoint for platelet count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.024
91567963|NCT00510146|183025090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for prolactin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567964|NCT00510146|183025091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for uric acid from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
91567965|NCT00510146|183025092|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value represents change from baseline to endpoint for fasting glucose from t-tests on change.|t-test, 2 sided|||||||0.047
91567966|NCT00510146|183025092|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||p-value represents change from baseline to endpoint for cholesterol from t-tests on change.|t-test, 2 sided|||||||0.130
91567967|NCT00510146|183025092|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||p-value represents change from baseline to endpoint for triglycerides from t-tests on change.|t-test, 2 sided|||||||0.055
91567968|NCT00510146|183025092|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change.|t-test, 2 sided|||||||0.049
91567969|NCT00510146|183025092|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change.|t-test, 2 sided|||||||<0.001
91567970|NCT00510146|183025093|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||p-value represents change from baseline to endpoint for QTcF from t-test.|t-test, 2 sided|||||||0.023
91567971|NCT00510146|183025093|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value represents change from baseline to endpoint for QTcB from t-test.|t-test, 2 sided|||||||0.044
91567972|NCT00510146|183025094|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||p-value represents change from baseline to endpoint for heart rate from t-test.|t-test, 2 sided|||||||0.919
91567973|NCT00776984|183025134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.091|0.217||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.091|<0.0001
91567974|NCT00776984|183025135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.169||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.169|0.053|0.0002
91567975|NCT00776984|183025136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
91567976|NCT00776984|183025137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0275||95.0|0.01|0.177||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.177|0.010|0.0275
91567977|NCT00776984|183025138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.041||0.0099||95.0|0.025|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|0.025|0.0099
91567978|NCT00776984|183025139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.084|0.202||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.202|0.084|<0.0001
91567979|NCT00776984|183025140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.187||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.187|0.031|0.0063
91567980|NCT00776984|183025141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.087|0.217||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.087|<0.0001
91567981|NCT00776984|183025142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.03||0.0026||95.0|0.032|0.151||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.151|0.032|0.0026
91567982|NCT00776984|183025143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.078|0.199||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.078|<0.0001
91567983|NCT00776984|183025144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0088||95.0|0.029|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.029|0.0088
91567984|NCT00776984|183025145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.042||0.0933||95.0|-0.012|0.153||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.153|-0.012|0.0933
91567985|NCT00776984|183025146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0074||95.0|0.029|0.189||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.189|0.029|0.0074
91567986|NCT00776984|183025147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.654|STANDARD_ERROR_OF_MEAN|4.807|<|0.0001||95.0|11.199|30.108||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||30.108|11.199|<0.0001
91567987|NCT00776984|183025148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.453|STANDARD_ERROR_OF_MEAN|5.044|<|0.0001||95.0|22.532|42.374||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||42.374|22.532|<0.0001
91567988|NCT00776984|183025149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0027||95.0|0.031|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.031|0.0027
91567989|NCT00776984|183025150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.074|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.074|<0.0001
91567990|NCT00776984|183025151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.197|STANDARD_ERROR_OF_MEAN|0.741||0.1073||95.0|-0.261|2.655||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||2.655|-0.261|0.1073
91567991|NCT00776984|183025152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4788||95.0|0.65|1.23||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.23|0.65|0.4788
91567992|NCT00776984|183025153|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|STANDARD_ERROR_OF_MEAN|0.11||0.1007||95.0|0.61|1.04||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.04|0.61|0.1007
91567993|NCT00776984|183025154|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|STANDARD_ERROR_OF_MEAN|0.15||0.7906||95.0|0.71|1.3||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.30|0.71|0.7906
91567994|NCT00776984|183025155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.004||95.0|0.38|0.84||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.84|0.38|0.0040
91567995|NCT00776984|183025156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5481||95.0|0.58|1.32||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.32|0.58|0.5481
91567996|NCT00776984|183025157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.7188||95.0|0.33|2.14||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||2.14|0.33|0.7188
91567997|NCT00776984|183025158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.23||0.8503||95.0|0.59|1.54||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo.|||1.54|0.59|0.8503
91567998|NCT00776984|183025159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.8129||95.0|0.29|2.46||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.46|0.29|0.8129
91567999|NCT00776984|183025160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.078||0.0225||95.0|0.025|0.331||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.331|0.025|0.0225
91568000|NCT00776984|183025161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.0803||95.0|-0.017|0.296||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.296|-0.017|0.0803
91568001|NCT00776984|183025162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.199|STANDARD_ERROR_OF_MEAN|0.067||0.003||95.0|-0.33|-0.068||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||-0.068|-0.330|0.0030
91568002|NCT00776984|183025163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.069||0.0533||95.0|-0.267|0.002||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.002|-0.267|0.0533
91568003|NCT00776984|183025164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.028||0.6632||95.0|-0.043|0.067||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.067|-0.043|0.6632
91568004|NCT00776984|183025165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|STANDARD_ERROR_OF_MEAN|0.189||0.1664||95.0|-0.635|0.11||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.110|-0.635|0.1664
91568005|NCT00776984|183025166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
91568006|NCT00776984|183025166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
91568007|NCT03790878|183025167|OTHER|||||||0.018|||||||ANCOVA|||||||0.018
91568008|NCT03790878|183025168|OTHER|||||||0.396|||||||Multilevel modeling|||||||0.396
91568009|NCT03790878|183025169|OTHER|||||||0.002|||||||Multilevel modeling|||||||0.002
91568010|NCT03640754|183025189|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91568011|NCT03640754|183025189|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91568012|NCT03640754|183025190|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91568013|NCT03640754|183025190|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91568014|NCT03640754|183025191|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91568015|NCT03640754|183025191|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
91568016|NCT03640754|183025192|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|||||||0.199
91568017|NCT03640754|183025192|SUPERIORITY|||||||0.189|||||||t-test, 1 sided|||||||0.189
91568018|NCT03640754|183025193|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.398|||||||Mixed Models Analysis|||||||0.398
91568019|NCT03640754|183025193|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.391|||||||Mixed Models Analysis|||||||0.391
91568020|NCT03640754|183025194|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.232
91568021|NCT03640754|183025194|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.085
91568022|NCT03640754|183025195|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|||||||0.501
91568023|NCT03640754|183025195|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.370
91568024|NCT03640754|183025196|SUPERIORITY|||||||0.333|||||||Mixed Models Analysis|||||||0.333
91568025|NCT03640754|183025196|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
91568026|NCT03640754|183025197|SUPERIORITY|||||||0.124|||||||Mixed Models Analysis|||||||0.124
91568027|NCT03640754|183025197|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|||||||0.175
91568028|NCT03640754|183025198|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
91568029|NCT03640754|183025198|SUPERIORITY|||||||0.077|||||||Mixed Models Analysis|||||||0.077
91568030|NCT03640754|183025202|SUPERIORITY|||||||0.047|||||||t-test, 1 sided|||||||0.047
91568031|NCT03640754|183025202|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|||||||0.139
91568032|NCT03640754|183025202|SUPERIORITY|||||||0.395|||||||t-test, 1 sided|||||||0.395
91568033|NCT03640754|183025203|SUPERIORITY|||||||0.147|||||||t-test, 1 sided|||||||0.147
91568034|NCT03640754|183025203|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.160
91568035|NCT03640754|183025203|SUPERIORITY|||||||0.152|||||||t-test, 1 sided|||||||0.152
91568036|NCT03640754|183025204|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|||||||0.286
91568037|NCT03640754|183025204|SUPERIORITY|||||||0.107|||||||t-test, 1 sided|||||||0.107
91568038|NCT03640754|183025205|SUPERIORITY|||||||0.289|||||||t-test, 1 sided|||||||0.289
91568039|NCT03640754|183025205|SUPERIORITY|||||||0.338|||||||t-test, 1 sided|||||||0.338
91568040|NCT03640754|183025206|SUPERIORITY|||||||0.393|||||||t-test, 1 sided|||||||0.393
91568041|NCT03640754|183025206|SUPERIORITY|||||||0.365|||||||t-test, 1 sided|||||||0.365
91568042|NCT03640754|183025207|SUPERIORITY|||||||0.406|||||||t-test, 1 sided|||||||0.406
91568043|NCT03640754|183025207|SUPERIORITY|||||||0.494|||||||t-test, 1 sided|||||||0.494
91568044|NCT00276016|183025209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0|||||ANOVA|||For endpoint||||0.561
91568045|NCT00276016|183025210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||For endpoint||||<.001
91568046|NCT04380688|183025219|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.553|||||TWO_SIDED|90.0|0.145|1.952||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.952|0.145|
91568047|NCT04380688|183025227|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|1.314|||||TWO_SIDED|90.0|0.794|2.183||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||2.183|0.794|
91568048|NCT05294328|183025253|SUPERIORITY||Odds Ratio (OR)|34.262|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
91568049|NCT05294328|183025253|SUPERIORITY||Odds Ratio (OR)|73.443|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
91568050|NCT02056873|183025254|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.05|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||"At 6 months post-surgery the YGTSS scores of each subjects is statistically tested against their baseline scores.~A decrease in this tic severity scale means that the severity of the tics have reduced.~Hence, we performed a superiority test, which statistically verifies if the reduction in the tic severity scale was meaningful."||||0.05
91568051|NCT01751165|183025298|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.98|1.39|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.||1.39|0.98|
91568052|NCT01751165|183025298|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.19|||||TWO_SIDED|97.5|0.93|1.53|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.||1.53|0.93|
91568053|NCT01036165|183025309|SUPERIORITY_OR_OTHER||Mean positive response|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower limit of the 95% confidence interval was \>0.50.|||0.86|0.70|
91568054|NCT01475461|183025311|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.5206|TWO_SIDED|80.0|-0.21|0.23||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.23|-0.21|0.5206
91568055|NCT01475461|183025311|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.178||0.1645|TWO_SIDED|80.0|-0.4|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo||0.05|-0.40|0.1645
91568056|NCT01475461|183025311|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.172||0.1592|TWO_SIDED|80.0|-0.39|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.05|-0.39|0.1592
91568057|NCT01475461|183025311|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0049|TWO_SIDED|80.0|-0.68|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.23|-0.68|0.0049
91568058|NCT01475461|183025311|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.173||0.0068|TWO_SIDED|80.0|-0.65|-0.21||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.21|-0.65|0.0068
91568059|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.3434|TWO_SIDED|80.0|-0.16|0.09||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.09|-0.16|0.3434
91568060|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.0892|TWO_SIDED|80.0|-0.27|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.27|0.0892
91568061|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.097||0.0826|TWO_SIDED|80.0|-0.26|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.26|0.0826
91568062|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.098||0.0031|TWO_SIDED|80.0|-0.4|-0.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.15|-0.40|0.0031
91568063|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.098||0.0005|TWO_SIDED|80.0|-0.45|-0.2||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0005
91568064|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.5133|TWO_SIDED|80.0|-0.18|0.19||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-0.18|0.5133
91568065|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.1873|TWO_SIDED|80.0|-0.33|0.06||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.33|0.1873
91568066|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.212|TWO_SIDED|80.0|-0.3|0.07||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.07|-0.30|0.2120
91568067|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.146||0.0001|TWO_SIDED|80.0|-0.73|-0.35||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.35|-0.73|0.0001
91568068|NCT01475461|183025312|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.0021|TWO_SIDED|80.0|-0.61|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.23|-0.61|0.0021
91568069|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|4.823||0.724|TWO_SIDED|80.0|-3.32|9.07||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.07|-3.32|0.7240
91568070|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77|STANDARD_ERROR_OF_MEAN|4.952||0.3608|TWO_SIDED|80.0|-8.13|4.59||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.59|-8.13|0.3608
91568071|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|4.816||0.2511|TWO_SIDED|80.0|-9.42|2.95||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.95|-9.42|0.2511
91568072|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.28|STANDARD_ERROR_OF_MEAN|4.851||0.0673|TWO_SIDED|80.0|-13.51|-1.05||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-1.05|-13.51|0.0673
91568073|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|4.843||0.0106|TWO_SIDED|80.0|-17.44|-5.0||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.00|-17.44|0.0106
91568074|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|5.138||0.4127|TWO_SIDED|80.0|-7.73|5.47||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.47|-7.73|0.4127
91568075|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|5.261||0.3604|TWO_SIDED|80.0|-8.64|4.87||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.87|-8.64|0.3604
91568076|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|5.147||0.077|TWO_SIDED|80.0|-13.96|-0.74||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.74|-13.96|0.0770
91568077|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|5.171||0.0451|TWO_SIDED|80.0|-15.43|-2.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.15|-15.43|0.0451
91568078|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|5.191||0.0001|TWO_SIDED|80.0|-26.57|-13.23||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-13.23|-26.57|0.0001
91568079|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|5.599||0.5783|TWO_SIDED|80.0|-6.08|8.3||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.30|-6.08|0.5783
91568080|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|5.785||0.3604|TWO_SIDED|80.0|-9.5|5.36||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.50|0.3604
91568081|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.12|STANDARD_ERROR_OF_MEAN|5.636||0.0161|TWO_SIDED|80.0|-19.36|-4.88||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.88|-19.36|0.0161
91568082|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|5.663||0.2185|TWO_SIDED|80.0|-11.68|2.87||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.87|-11.68|0.2185
91568083|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.41|STANDARD_ERROR_OF_MEAN|5.649||0.0034|TWO_SIDED|80.0|-22.67|-8.16||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.16|-22.67|0.0034
91568084|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|6.387||0.5727|TWO_SIDED|80.0|-7.03|9.37||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.37|-7.03|0.5727
91568085|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|6.578||0.4961|TWO_SIDED|80.0|-8.51|8.38||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.38|-8.51|0.4961
91568086|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.411||0.2616|TWO_SIDED|80.0|-12.33|4.14||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.14|-12.33|0.2616
91568087|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|6.441||0.9197|TWO_SIDED|80.0|0.79|17.34||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||17.34|0.79|0.9197
91568088|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|6.398||0.086|TWO_SIDED|80.0|-16.98|-0.54||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.54|-16.98|0.0860
91568089|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|6.476||0.5132|TWO_SIDED|80.0|-8.1|8.53||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.53|-8.10|0.5132
91568090|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|6.676||0.656|TWO_SIDED|80.0|-5.89|11.26||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.26|-5.89|0.6560
91568091|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|6.17|STANDARD_ERROR_OF_MEAN|6.496||0.8285|TWO_SIDED|80.0|-2.17|14.52||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.52|-2.17|0.8285
91568092|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|15.98|STANDARD_ERROR_OF_MEAN|6.527||0.9925|TWO_SIDED|80.0|7.59|24.36||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||24.36|7.59|0.9925
91568093|NCT01475461|183025313|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|6.487||0.601|TWO_SIDED|80.0|-6.67|10.0||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.00|-6.67|0.6010
91568094|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|0.449||0.0913|TWO_SIDED|80.0|0.18|1.34||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.34|0.18|0.0913
91568095|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.461||0.5236|TWO_SIDED|80.0|-0.3|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.30|0.5236
91568096|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.447||0.9244|TWO_SIDED|80.0|-0.53|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.53|0.9244
91568097|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.452||0.5066|TWO_SIDED|80.0|-0.28|0.88||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.88|-0.28|0.5066
91568098|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.449||0.8947|TWO_SIDED|80.0|-0.64|0.52||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.64|0.8947
91568099|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.478||0.0577|TWO_SIDED|80.0|0.3|1.52||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.52|0.30|0.0577
91568100|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.3012|TWO_SIDED|80.0|-0.12|1.14||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.14|-0.12|0.3012
91568101|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.476||0.3165|TWO_SIDED|80.0|-0.13|1.09||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.09|-0.13|0.3165
91568102|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.481||0.5191|TWO_SIDED|80.0|-0.31|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.31|0.5191
91568103|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.479||0.5107|TWO_SIDED|80.0|-0.3|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.30|0.5107
91568104|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.488||0.1054|TWO_SIDED|80.0|0.17|1.42||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.42|0.17|0.1054
91568105|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.502||0.5341|TWO_SIDED|80.0|-0.33|0.96||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.96|-0.33|0.5341
91568106|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.487||0.2782|TWO_SIDED|80.0|-0.1|1.15||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.15|-0.10|0.2782
91568107|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.492||0.5331|TWO_SIDED|80.0|-0.32|0.94||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.32|0.5331
91568108|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.489||0.907|TWO_SIDED|80.0|-0.57|0.68||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.68|-0.57|0.9070
91568109|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.512||0.1757|TWO_SIDED|80.0|0.04|1.35||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.35|0.04|0.1757
91568110|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.527||0.4083|TWO_SIDED|80.0|-0.24|1.11||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.11|-0.24|0.4083
91568111|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.511||0.315|TWO_SIDED|80.0|-0.14|1.17||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.17|-0.14|0.3150
91568112|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.516||0.6631|TWO_SIDED|80.0|-0.44|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.44|0.6631
91568113|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.512||0.8694|TWO_SIDED|80.0|-0.74|0.57||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-0.74|0.8694
91568114|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.545||0.2031|TWO_SIDED|80.0|0.0|1.4||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.40|0.00|0.2031
91568115|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.563||0.7137|TWO_SIDED|80.0|-0.52|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.52|0.7137
91568116|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.545||0.681|TWO_SIDED|80.0|-0.48|0.92||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.48|0.6810
91568117|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.55||0.6921|TWO_SIDED|80.0|-0.92|0.49||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.49|-0.92|0.6921
91568118|NCT01475461|183025320|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.545||0.3702|TWO_SIDED|80.0|-1.19|0.21||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.21|-1.19|0.3702
91568119|NCT01049984|183025331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.012|TWO_SIDED|95.0|-4.3|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-4.3|0.012
91568120|NCT01049984|183025332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.301|TWO_SIDED|95.0|-1.1|0.3||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||0.3|-1.1|0.301
91568121|NCT01049984|183025333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.007|TWO_SIDED|95.0|-3.1|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-3.1|0.007
91568122|NCT01049984|183025334|SUPERIORITY_OR_OTHER|||||||0.255||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.255
91568123|NCT01049984|183025335|SUPERIORITY_OR_OTHER|||||||0.996||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.996
91568124|NCT01049984|183025336|SUPERIORITY_OR_OTHER|||||||0.967||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment, pooled center, and baseline value as strata.||||||0.967
91568125|NCT00553605|183025337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.|Least-squares (LS) mean difference|-1.12|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.53|4.3||||||LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.||4.30|-6.53|
91568126|NCT00553605|183025338|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|2.52||0.972|TWO_SIDED|95.0|-5.04|4.86|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||4.86|-5.04|0.972
91568127|NCT00553605|183025340|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|2.56||0.768|TWO_SIDED|95.0|-4.28|5.79|||ANCOVA|||Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.79|-4.28|0.768
91568128|NCT00553605|183025340|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|2.91||0.866|TWO_SIDED|95.0|-6.22|5.24|||ANCOVA|||Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.24|-6.22|0.866
91568129|NCT00553605|183025340|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|2.7||0.729|TWO_SIDED|95.0|-4.38|6.26|||ANCOVA|||Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.26|-4.38|0.729
91568130|NCT00553605|183025340|SUPERIORITY_OR_OTHER||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.47||0.29|TWO_SIDED|95.0|-2.24|7.48|||ANCOVA|||Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||7.48|-2.24|0.290
91568131|NCT00553605|183025340|SUPERIORITY_OR_OTHER||LS mean difference|2.16|STANDARD_ERROR_OF_MEAN|2.14||0.314|TWO_SIDED|95.0|-2.05|6.37|||ANCOVA|||Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.37|-2.05|0.314
91568132|NCT00553605|183025340|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|1.72||0.926|TWO_SIDED|95.0|-3.23|3.55|||ANCOVA|||Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||3.55|-3.23|0.926
91568133|NCT00553605|183025341|SUPERIORITY_OR_OTHER||LS mean difference|10.13|STANDARD_ERROR_OF_MEAN|13.43||0.451|TWO_SIDED|95.0|-16.3|36.54|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.||36.54|-16.3|0.451
91568134|NCT00553605|183025342|SUPERIORITY_OR_OTHER|||||||0.3982|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.3982
91568135|NCT00553605|183025342|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.5552
91568136|NCT00553605|183025343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.007||||0.9785|TWO_SIDED|95.0|0.6|1.69|||Regression, Logistic|||p-value was based on logistic regression model with terms for treatment group and baseline as covariates.||1.69|0.60|0.9785
91568137|NCT00553605|183025344|SUPERIORITY_OR_OTHER|||||||0.2482|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.2482
91568138|NCT00553605|183025344|SUPERIORITY_OR_OTHER|||||||0.7659|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.7659
91568139|NCT00553605|183025345|SUPERIORITY_OR_OTHER|||||||0.9783|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.9783
91568140|NCT00553605|183025345|SUPERIORITY_OR_OTHER|||||||0.6847|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.6847
91568141|NCT00553605|183025346|SUPERIORITY_OR_OTHER|||||||0.9645|TWO_SIDED||||||Log Rank|||||||0.9645
91568142|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.016|0.092|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.092|0.016|
91568143|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.027|0.103|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.103|0.027|
91568144|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.046|0.122|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.122|0.046|
91568145|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.027|0.049|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.049|-0.027|
91568146|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.008|0.069|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.069|-0.008|
91568147|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.058|-0.019|
91568148|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.013|0.089|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.089|0.013|
91568149|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.045|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.122|0.045|
91568150|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.042|0.119|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.119|0.042|
91568151|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.071|-0.006|
91568152|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.009|0.068|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.068|-0.009|
91568153|NCT01040403|183025358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.041|0.035|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.035|-0.041|
91568154|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.04|0.159|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.159|0.040|
91568155|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.061|0.179|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.179|0.061|
91568156|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.041|0.16|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.160|0.041|
91568157|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.039|0.079|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.079|-0.039|
91568158|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.061|-0.059|
91568159|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.04|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.040|-0.079|
91568160|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.071|0.19|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.190|0.071|
91568161|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.191|0.072|
91568162|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.067|0.187|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.187|0.067|
91568163|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.061|-0.059|
91568164|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.063|0.056|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.056|-0.063|
91568165|NCT01040403|183025359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.064|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.064|
91568166|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.035|0.114|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.114|0.035|
91568167|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.137|0.057|
91568168|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.079|0.159|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.159|0.079|
91568169|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.017|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.062|-0.017|
91568170|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.021|||TWO_SIDED|95.0|0.004|0.085|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.085|0.004|
91568171|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.018|0.062|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.062|-0.018|
91568172|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.137|0.057|
91568173|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.088|0.168|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.168|0.088|
91568174|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.103|0.183|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.183|0.103|
91568175|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.071|-0.009|
91568176|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.086|0.006|
91568177|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.025|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.055|-0.025|
91568178|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.04|0.117|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.117|0.040|
91568179|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.06|0.137|||Mixed Models Analysis||difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.137|0.060|
91568180|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.08|0.157|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.157|0.080|
91568181|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.018|0.058|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.058|-0.018|
91568182|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.001|0.079|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.079|0.001|
91568183|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.058|-0.019|
91568184|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.06|0.136|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.136|0.060|
91568185|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.083|0.159|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.159|0.083|
91568186|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.105|0.182|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.182|0.105|
91568187|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.062|-0.016|
91568188|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.007|0.084|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.084|0.007|
91568189|NCT01040403|183025360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.061|-0.016|
91568190|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.058|0.012|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.012|-0.058|
91568191|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.040|-0.029|
91568192|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.034|0.036|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.036|-0.034|
91568193|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.006|0.063|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.063|-0.006|
91568194|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.011|0.059|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.059|-0.011|
91568195|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.039|0.031|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.031|-0.039|
91568196|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.004|0.073|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.073|0.004|
91568197|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.004|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.066|-0.004|
91568198|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.006|0.076|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.076|0.006|
91568199|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.043|0.027|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.027|-0.043|
91568200|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.032|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.037|-0.032|
91568201|NCT01040403|183025361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.025|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.045|-0.025|
91568202|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.041|0.138|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.138|0.041|
91568203|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.043|0.139|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.139|0.043|
91568204|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.066|0.164|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.164|0.066|
91568205|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.046|0.05|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.050|-0.046|
91568206|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.023|0.074|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.074|-0.023|
91568207|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.025|0.072|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.072|-0.025|
91568208|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.059|0.156|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.156|0.059|
91568209|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.084|0.181|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.181|0.084|
91568210|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.096|0.193|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.193|0.096|
91568211|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.024|0.074|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.074|-0.024|
91568212|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.01|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.086|-0.010|
91568213|NCT01040403|183025362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.036|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.061|-0.036|
91568214|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.059|0.02|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.020|-0.059|
91568215|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.026|0.053|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.053|-0.026|
91568216|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.028|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.051|-0.028|
91568217|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.072|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.072|-0.006|
91568218|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.071|-0.009|
91568219|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.041|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.037|-0.041|
91568220|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.015|0.093|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.093|0.015|
91568221|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.084|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.084|0.006|
91568222|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.008|0.087|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.087|0.008|
91568223|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.049|0.031|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.031|-0.049|
91568224|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.046|0.033|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.033|-0.046|
91568225|NCT01040403|183025363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.037|0.042|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.042|-0.037|
91568226|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.084|0.202|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.202|0.084|
91568227|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.092|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.210|0.092|
91568228|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.191|0.072|
91568229|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.051|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.066|-0.051|
91568230|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.071|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.048|-0.071|
91568231|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.039|-0.079|
91568232|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.234|0.116|
91568233|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.234|0.116|
91568234|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.14|0.259|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.259|0.140|
91568235|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.06|0.059|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.059|-0.060|
91568236|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.083|-0.035|
91568237|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.083|-0.035|
91568238|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.081|0.197|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.197|0.081|
91568239|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.092|0.207|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.207|0.092|
91568240|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.073|0.189|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.189|0.073|
91568241|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.047|0.068|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.068|-0.047|
91568242|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.066|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.051|-0.066|
91568243|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.076|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.039|-0.076|
91568244|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.131|0.247|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.247|0.131|
91568245|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.121|0.236|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.236|0.121|
91568246|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.155|0.271|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.271|0.155|
91568247|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.069|0.048|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.048|-0.069|
91568248|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.033|0.082|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.082|-0.033|
91568249|NCT01040403|183025364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.023|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.092|-0.023|
91568250|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.106|0.01|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.010|-0.106|
91568251|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.051|-0.065|
91568252|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.072|0.044|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.044|-0.072|
91568253|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.017|0.099|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.099|-0.017|
91568254|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.024|0.093|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.093|-0.024|
91568255|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.051|-0.065|
91568256|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.032|0.148|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.148|0.032|
91568257|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.001|0.118|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.118|0.001|
91568258|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.002|0.114|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.114|-0.002|
91568259|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.089|0.028|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.028|-0.089|
91568260|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.092|0.024|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.024|-0.092|
91568261|NCT01040403|183025365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.062|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.062|
91568262|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.087|0.223|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.223|0.087|
91568263|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.079|0.215|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.215|0.079|
91568264|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.058|0.195|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.195|0.058|
91568265|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.075|0.06|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.060|-0.075|
91568266|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.097|0.041|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.041|-0.097|
91568267|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.089|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.048|-0.089|
91568268|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.106|0.242|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.242|0.106|
91568269|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.113|0.25|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.250|0.113|
91568270|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.135|0.272|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.272|0.135|
91568271|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.061|0.076|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.076|-0.061|
91568272|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.038|0.098|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.098|-0.038|
91568273|NCT01040403|183025366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.046|0.09|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.090|-0.046|
91568274|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.114|0.013|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.013|-0.114|
91568275|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.055|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.071|-0.055|
91568276|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.074|0.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.053|-0.074|
91568277|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.004|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.122|-0.004|
91568278|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.024|0.104|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.104|-0.024|
91568279|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.082|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus +O 2.5/5|||0.045|-0.082|
91568280|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.047|0.174|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.174|0.047|
91568281|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.017|0.144|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.144|0.017|
91568282|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.005|0.132|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.132|0.005|
91568283|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.094|0.034|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.034|-0.094|
91568284|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.105|0.021|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.021|-0.105|
91568285|NCT01040403|183025367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.075|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.052|-0.075|
91568286|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.759|STANDARD_ERROR_OF_MEAN|4.189|||TWO_SIDED|95.0|10.533|26.985|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||26.985|10.533|
91568287|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.157|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|16.962|33.351|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||33.351|16.962|
91568288|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.804|STANDARD_ERROR_OF_MEAN|4.216|||TWO_SIDED|95.0|21.526|38.082|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||38.082|21.526|
91568289|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.398|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|-1.796|14.592|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||14.592|-1.796|
91568290|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.046|STANDARD_ERROR_OF_MEAN|4.239|||TWO_SIDED|95.0|2.721|19.37|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||19.370|2.721|
91568291|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.648|STANDARD_ERROR_OF_MEAN|4.204|||TWO_SIDED|95.0|-3.608|12.903|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||12.903|-3.608|
91568292|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.318|STANDARD_ERROR_OF_MEAN|4.201|||TWO_SIDED|95.0|10.068|26.568|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||26.568|10.068|
91568293|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.511|STANDARD_ERROR_OF_MEAN|4.197|||TWO_SIDED|95.0|15.27|31.752|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||31.752|15.270|
91568294|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.817|STANDARD_ERROR_OF_MEAN|4.214|||TWO_SIDED|95.0|14.543|31.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||31.092|14.543|
91568295|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.193|STANDARD_ERROR_OF_MEAN|4.23|||TWO_SIDED|95.0|-3.115|13.5|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||13.500|-3.115|
91568296|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.499|STANDARD_ERROR_OF_MEAN|4.185|||TWO_SIDED|95.0|-3.719|12.717|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||12.717|-3.719|
91568297|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.694|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-8.941|7.554|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||7.554|-8.941|
91568298|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.751|STANDARD_ERROR_OF_MEAN|4.013|||TWO_SIDED|95.0|10.87|26.632|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||26.632|10.870|
91568299|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.009|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|18.158|33.86|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||33.860|18.158|
91568300|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.347|STANDARD_ERROR_OF_MEAN|4.039|||TWO_SIDED|95.0|21.416|37.278|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||37.278|21.416|
91568301|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.259|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|-0.592|15.109|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||15.109|-0.592|
91568302|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.596|STANDARD_ERROR_OF_MEAN|4.061|||TWO_SIDED|95.0|2.621|18.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||18.571|2.621|
91568303|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.337|STANDARD_ERROR_OF_MEAN|4.028|||TWO_SIDED|95.0|-4.572|11.247|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||11.247|-4.572|
91568304|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.654|STANDARD_ERROR_OF_MEAN|4.025|||TWO_SIDED|95.0|11.75|27.558|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||27.558|11.750|
91568305|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.762|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|14.866|30.659|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||30.659|14.866|
91568306|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.536|STANDARD_ERROR_OF_MEAN|4.038|||TWO_SIDED|95.0|17.607|33.464|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||33.464|17.607|
91568307|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.108|STANDARD_ERROR_OF_MEAN|4.053|||TWO_SIDED|95.0|-4.852|11.067|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||11.067|-4.852|
91568308|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.881|STANDARD_ERROR_OF_MEAN|4.009|||TWO_SIDED|95.0|-1.991|13.754|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||13.754|-1.991|
91568309|NCT01040403|183025368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.773|STANDARD_ERROR_OF_MEAN|4.024|||TWO_SIDED|95.0|-5.129|10.675|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||10.675|-5.129|
91568310|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.316|STANDARD_ERROR_OF_MEAN|4.371|||TWO_SIDED|95.0|-6.268|10.9|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.900|-6.268|
91568311|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.478|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-4.088|13.044|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.044|-4.088|
91568312|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.668|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-3.978|13.314|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||13.314|-3.978|
91568313|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.162|STANDARD_ERROR_OF_MEAN|4.349|||TWO_SIDED|95.0|-6.379|10.702|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||10.702|-6.379|
91568314|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.352|STANDARD_ERROR_OF_MEAN|4.419|||TWO_SIDED|95.0|-6.326|11.029|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||11.029|-6.326|
91568315|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|-8.43|8.81|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||8.810|-8.430|
91568316|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.488|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-7.136|10.113|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||10.113|-7.136|
91568317|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.262|STANDARD_ERROR_OF_MEAN|4.386|||TWO_SIDED|95.0|-5.35|11.875|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||11.875|-5.350|
91568318|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.121|STANDARD_ERROR_OF_MEAN|4.408|||TWO_SIDED|95.0|-1.535|15.778|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||15.778|-1.535|
91568319|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.774|STANDARD_ERROR_OF_MEAN|4.423|||TWO_SIDED|95.0|-6.91|10.458|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||10.458|-6.910|
91568320|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.663|STANDARD_ERROR_OF_MEAN|4.381|||TWO_SIDED|95.0|-2.97|14.236|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||14.236|-2.970|
91568321|NCT01040403|183025369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-4.786|12.504|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.504|-4.786|
91568322|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.682|STANDARD_ERROR_OF_MEAN|4.849|||TWO_SIDED|95.0|9.161|28.204|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||28.204|9.161|
91568323|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.599|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|14.116|33.083|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||33.083|14.116|
91568324|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.097|STANDARD_ERROR_OF_MEAN|4.879|||TWO_SIDED|95.0|20.517|39.677|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||39.677|20.517|
91568325|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.917|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-4.568|14.402|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||14.402|-4.568|
91568326|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.415|STANDARD_ERROR_OF_MEAN|4.907|||TWO_SIDED|95.0|1.78|21.05|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||21.050|1.780|
91568327|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.498|STANDARD_ERROR_OF_MEAN|4.866|||TWO_SIDED|95.0|-3.057|16.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||16.053|-3.057|
91568328|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.742|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|8.194|27.29|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||27.290|8.194|
91568329|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.115|STANDARD_ERROR_OF_MEAN|4.856|||TWO_SIDED|95.0|14.58|33.651|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||33.651|14.580|
91568330|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.095|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|15.52|34.67|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||34.670|15.520|
91568331|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.373|STANDARD_ERROR_OF_MEAN|4.896|||TWO_SIDED|95.0|-3.24|15.986|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||15.986|-3.240|
91568332|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.353|STANDARD_ERROR_OF_MEAN|4.845|||TWO_SIDED|95.0|-2.161|16.866|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||16.866|-2.161|
91568333|NCT01040403|183025370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|4.861|||TWO_SIDED|95.0|-8.566|10.525|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||10.525|-8.566|
91568334|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_ERROR_OF_MEAN|4.853|||TWO_SIDED|95.0|-8.36|10.699|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.699|-8.360|
91568335|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.436|STANDARD_ERROR_OF_MEAN|4.843|||TWO_SIDED|95.0|-5.073|13.945|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.945|-5.073|
91568336|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.189|STANDARD_ERROR_OF_MEAN|4.887|||TWO_SIDED|95.0|-4.407|14.785|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||14.785|-4.407|
91568337|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-6.214|12.747|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||12.747|-6.214|
91568338|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|4.904|||TWO_SIDED|95.0|-5.61|13.65|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||13.650|-5.610|
91568339|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753|STANDARD_ERROR_OF_MEAN|4.873|||TWO_SIDED|95.0|-8.816|10.322|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||10.322|-8.816|
91568340|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.986|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|-6.589|12.561|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||12.561|-6.589|
91568341|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.916|STANDARD_ERROR_OF_MEAN|4.868|||TWO_SIDED|95.0|-4.643|14.475|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||14.475|-4.643|
91568342|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.432|STANDARD_ERROR_OF_MEAN|4.882|||TWO_SIDED|95.0|-2.154|17.019|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||17.019|-2.154|
91568343|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_ERROR_OF_MEAN|4.909|||TWO_SIDED|95.0|-7.708|11.568|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||11.568|-7.708|
91568344|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.446|STANDARD_ERROR_OF_MEAN|4.854|||TWO_SIDED|95.0|-5.085|13.978|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||13.978|-5.085|
91568345|NCT01040403|183025371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|95.0|-7.046|12.079|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.079|-7.046|
91568346|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.212|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|95.0|-0.523|0.099|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 1||0.099|-0.523|
91568347|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.634|-0.004|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 1||-0.004|-0.634|
91568348|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.379|0.249|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 1||0.249|-0.379|
91568349|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.107|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.42|0.206|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 1||0.206|-0.420|
91568350|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.168|0.462|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 1||0.462|-0.168|
91568351|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|95.0|-0.062|0.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 1||0.571|-0.062|
91568352|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.271|0.355|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 1||0.355|-0.271|
91568353|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.564|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 1||0.062|-0.564|
91568354|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.492|0.135|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 1||0.135|-0.492|
91568355|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.611|0.024|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 1||0.024|-0.611|
91568356|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.533|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 1||0.092|-0.533|
91568357|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.242|0.388|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 1||0.388|-0.242|
91568358|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.241|0.462|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 4||0.462|-0.241|
91568359|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.445|0.261|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 4||0.261|-0.445|
91568360|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.301|0.406|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 4||0.406|-0.301|
91568361|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.555|0.15|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 4||0.150|-0.555|
91568362|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.411|0.296|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 4||0.296|-0.411|
91568363|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.208|0.496|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 4||0.496|-0.208|
91568364|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.217|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.568|0.135|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 4||0.135|-0.568|
91568365|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.714|-0.012|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 4||-0.012|-0.714|
91568366|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.246|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.598|0.106|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 4||0.106|-0.598|
91568367|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|95.0|-0.503|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 4||0.210|-0.503|
91568368|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.178|||TWO_SIDED|95.0|-0.379|0.321|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 4||0.321|-0.379|
91568369|NCT01040403|183025375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.235|0.47|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 4||0.470|-0.235|
91568370|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.223|0.25|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Day 1||0.250|-0.223|
91568371|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.37|0.104|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 1||0.104|-0.370|
91568372|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.278|0.199|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 1||0.199|-0.278|
91568373|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.382|0.088|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 1||0.088|-0.382|
91568374|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.291|0.186|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 1||0.186|-0.291|
91568375|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.144|0.332|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 1||0.332|-0.144|
91568376|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.519|-0.045|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 1||-0.045|-0.519|
91568377|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.35|0.124|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 1||0.124|-0.350|
91568378|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.293|0.18|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 1||0.180|-0.293|
91568379|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.069|0.408|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 1||0.408|-0.069|
91568380|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.461|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 1||0.461|-0.010|
91568381|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.18|0.293|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 1||0.293|-0.180|
91568382|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.067|0.387|||Mixed Models Analysis||Difference calculated as T+O 1.25/ minus Olo 5|Day 29||0.387|-0.067|
91568383|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.034|0.491|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 29||0.491|0.034|
91568384|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.148|0.316|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 29||0.316|-0.148|
91568385|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|-0.124|0.328|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 29||0.328|-0.124|
91568386|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.306|0.154|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 29||0.154|-0.306|
91568387|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.408|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 29||0.052|-0.408|
91568388|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.056|0.4|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 29||0.400|-0.056|
91568389|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.171|0.285|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 29||0.285|-0.171|
91568390|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.11|0.346|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 29||0.346|-0.110|
91568391|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.345|0.115|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 29||0.115|-0.345|
91568392|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.281|0.173|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 29||0.173|-0.281|
91568393|NCT01040403|183025376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.166|0.289|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 29||0.289|-0.166|
91568394|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.481|0.037|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.037|-0.481|
91568395|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.7|-0.182|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||-0.182|-0.700|
91568396|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.409|0.111|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.111|-0.409|
91568397|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.478|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.040|-0.478|
91568398|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.189|0.335|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.335|-0.189|
91568399|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.031|0.553|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.553|0.031|
91568400|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.641|-0.123|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||-0.123|-0.641|
91568401|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.132|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.39|0.127|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.127|-0.390|
91568402|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.585|-0.067|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||-0.067|-0.585|
91568403|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.01|0.511|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.511|-0.010|
91568404|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.202|0.314|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.314|-0.202|
91568405|NCT01040403|183025377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.453|0.065|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.065|-0.453|
91568406|NCT05694533|183025380|OTHER|Descriptive only.|Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.76|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.76|
91568407|NCT05694533|183025380|OTHER|Descriptive only.|Geometric Mean Ratio|0.8|||||TWO_SIDED|90.0|0.69|0.93||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.93|0.69|
91568408|NCT05694533|183025381|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.78|
91568409|NCT05694533|183025381|OTHER|Descriptive only.|Geometric Mean Ratio|0.81|||||TWO_SIDED|90.0|0.74|0.89||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.89|0.74|
91568410|NCT05694533|183025382|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.91||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.91|0.78|
91568411|NCT05694533|183025382|OTHER|Descriptive only.|Geometric Mean Ratio|0.87|||||TWO_SIDED|90.0|0.78|0.97||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.97|0.78|
91568412|NCT02005393|183025385|NON_INFERIORITY_OR_EQUIVALENCE|Image settings were considered non-inferior if scores overlapped within 1 SD of mean.||||||||||||||||All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).|The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.|||
91568413|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.89|1.33||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.33|0.89|
91568414|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.92|||||TWO_SIDED|95.0|0.75|1.12||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.12|0.75|
91568415|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.03|||||TWO_SIDED|95.0|0.85|1.26||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.26|0.85|
91568416|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.12|||||TWO_SIDED|95.0|0.78|1.61||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.61|0.78|
91568417|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.88|
91568418|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.88|||||TWO_SIDED|95.0|0.69|1.13||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.13|0.69|
91568419|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.73|1.31||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.31|0.73|
91568420|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.08|||||TWO_SIDED|95.0|0.86|1.37||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.37|0.86|
91568421|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.78|
91568422|NCT02447432|183025415|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.28|||||TWO_SIDED|95.0|0.92|1.8||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.80|0.92|
91568423|NCT02561806|183025540|NON_INFERIORITY|Non-inferiority margin was -12.6% for 97.5% confidence interval|Risk Difference (RD)|0.321|||<|0.001|TWO_SIDED|97.5|0.198|0.445|||Regression, Logistic|||||0.445|0.198|<0.001
91568424|NCT02561806|183025541|SUPERIORITY||Risk Ratio (RR)|1.285|||<|0.001|TWO_SIDED|95.0|1.13|1.439|||Regression, Logistic|||||1.439|1.130|<0.001
91568425|NCT02561806|183025542|SUPERIORITY||Risk Ratio (RR)|2.699||||0.009|TWO_SIDED|95.0|1.423|3.975|||Regression, Logistic|||||3.975|1.423|0.009
91568426|NCT02561806|183025543|SUPERIORITY||Risk Ratio (RR)|1.469|||<|0.001|TWO_SIDED|95.0|1.244|1.695|||Regression, Logistic|||||1.695|1.244|<0.001
91568427|NCT02561806|183025544|SUPERIORITY||Risk Ratio (RR)|3.421||||0.021|TWO_SIDED|95.0|1.353|5.488|||Regression, Logistic|||||5.488|1.353|0.021
91568428|NCT02561806|183025551|SUPERIORITY||Risk Ratio (RR)|1.391||||0.012|TWO_SIDED|95.0|1.085|1.698|||Regression, Logistic|||||1.698|1.085|0.012
91568429|NCT04358068|183025696|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.51||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.51
91568430|NCT04358068|183025697|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.79||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.79
91568431|NCT04358068|183025698|SUPERIORITY|Participant specific AUCs were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.53||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.53
91568432|NCT04358068|183025699|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.83||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.83
91568433|NCT01193218|183025703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.57||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 5mg minus placebo||-0.57|-0.87|<0.0001
91568434|NCT01193218|183025703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 10mg minus placebo||-0.55|-0.85|<0.0001
91568435|NCT01193218|183025703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 25mg minus placebo||-0.80|-1.10|<0.0001
91568436|NCT01193218|183025703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 50mg minus placebo||-0.76|-1.06|<0.0001
91568437|NCT01193218|183025704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.367|||<|0.0001|TWO_SIDED|95.0|5.34|70.236|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo||70.236|5.340|<0.0001
91568438|NCT01193218|183025704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.889||||0.0003|TWO_SIDED|95.0|2.942|40.301|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo||40.301|2.942|0.0003
91568439|NCT01193218|183025704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.624|||<|0.0001|TWO_SIDED|95.0|7.601|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo||99.99|7.601|<0.0001
91568440|NCT01193218|183025704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.906|||<|0.0001|TWO_SIDED|95.0|12.12|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo||99.99|12.120|<0.0001
91568441|NCT01193218|183025705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.7|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-31.61|-21.8|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 5mg minus placebo||-21.80|-31.61|<0.0001
91568442|NCT01193218|183025705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.34|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-34.25|-24.42|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 10mg minus placebo||-24.42|-34.25|<0.0001
91568443|NCT01193218|183025705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.75|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-42.66|-32.84|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 25mg minus placebo||-32.84|-42.66|<0.0001
91568444|NCT01193218|183025705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-41.51|-31.69|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 50mg minus placebo||-31.69|-41.51|<0.0001
91568445|NCT00665223|183025709|SUPERIORITY|This analysis compared ACR16 45 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.36||||0.456|TWO_SIDED|97.5|-1.44|0.72|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.72|-1.44|0.456
91568446|NCT00665223|183025709|SUPERIORITY|This analysis compared ACR16 90 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.99||||0.042|TWO_SIDED|97.5|-2.08|0.1|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.10|-2.08|0.042
91568447|NCT00002597|183025722|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.0309|TWO_SIDED|95.0|1.01|1.35|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.||1.35|1.01|0.0309
91568448|NCT00002597|183025723|SUPERIORITY||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.27|2.74|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.74|1.27|0.001
91568449|NCT00002597|183025724|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0013|TWO_SIDED|95.0|1.17|1.93|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.93|1.17|0.0013
91568450|NCT00002597|183025725|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.035|TWO_SIDED|95.0|1.03|2.06|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.06|1.03|0.035
91568451|NCT00002597|183025726|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.48|2.04|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.04|1.48|<0.001
91568452|NCT00002597|183025727|SUPERIORITY||Hazard Ratio (HR)|1.5|||<|0.001|TWO_SIDED|95.0|1.21|1.85|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.85|1.21|<0.001
91568453|NCT00002597|183025728|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.001|TWO_SIDED|95.0|1.34|3.16|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||3.16|1.34|<0.001
91568454|NCT00002597|183025729|SUPERIORITY||Hazard Ratio (HR)|1.38|||<|0.001|TWO_SIDED|95.0|1.22|1.56|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Treatment arms were compared using the log-rank test (one-sided significance level of 0.025).||1.56|1.22|<0.001
91568455|NCT00002597|183025730|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91568456|NCT05324007|183025744|EQUIVALENCE|Estimated effect size was based on Liberman et al. (2017) that found a partial eta squared of .478 for the interaction between different-language and same-language conditions. Using G\*power using an alpha of .05, our target sample size of 30 per condition should provide 99.73% power to detect the main effect in the White-White and Black-Black condition and 99.99% power to detect the main effect in the Black-White condition.|partial eta squared|0.062|||<|0.05|TWO_SIDED||||||ANOVA|||We will examine whether looking time at affiliation will be greater when looking at Black-White interactions than at White-White or Black-Black interactions. That is, we will test if infants will be more surprised (look longer) by affiliation between different-race people interacting than same race people interacting. We will conduct a mixed ANOVA with conditions (Black-White, White-White, Black-Black) as a between-subject and test type (affiliation vs. disengagement) as within-subject factors.||||<.05
91568457|NCT02573883|183025772|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
91568458|NCT02573883|183025773|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
91568459|NCT02573883|183025775|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
91568460|NCT02573883|183025777|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
91568461|NCT00582114|183025788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.001|TWO_SIDED|95.0|1.36|4.23|||Mixed Models Analysis|||Cardiovascular events were counted by subject and included the following: myocardial infarction, stroke, hospitalization for congestive heart failure, hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||4.23|1.36|0.001
91568462|NCT00582114|183025788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.29||||0.02|TWO_SIDED|95.0|1.07|5.21|||Mixed Models Analysis|||As a post hoc analysis, we determined the narrower definition of cardiovascular events per group that included myocardial infarction, stroke, congestive heart failure or cardiovascular death. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||5.21|1.07|0.02
91568463|NCT00582114|183025788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.13||||0.02|TWO_SIDED|95.0|1.08|10.99|||Mixed Models Analysis|||Hospitalization for congestive heart failure between groups was analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||10.99|1.08|0.02
91568464|NCT00582114|183025788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.002|TWO_SIDED|95.0|1.18|2.19|||Mixed Models Analysis|||All-cause hospitalizations between groups were analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||2.19|1.18|0.002
91568465|NCT00130728|183025804|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7583||95.0|0.799|1.177||relative to placebo arm|Log Rank||Stratified analysis; Hazard ratio is relative to placebo arm.|||1.177|0.799|0.7583
91568466|NCT00130728|183025805|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.623|||<|0.0001||95.0|0.519|0.748||relative to placebo arm|Log Rank||Stratified analysis; hazard ratio is relative to placebo arm.|||0.748|0.519|<.0001
91568467|NCT00130728|183025806|SUPERIORITY_OR_OTHER_LEGACY||Percentage difference|6.4||||0.0068||95.0|1.8|11.3||Relative to placebo arm|Mantel Haenszel||Difference in objective response rates relative to placebo arm|||11.3|1.8|0.0068
91568468|NCT02341599|183025814|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.29|||||TWO_SIDED|90.0|1.06|1.58|||||LS mean ratio was calculated from analysis of variance (ANOVA) model.|||1.58|1.06|
91568469|NCT02341599|183025814|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|1.08|||||TWO_SIDED|90.0|0.889|1.32|||||LS mean ratio was calculated from ANOVA model.|||1.32|0.889|
91568470|NCT02341599|183025814|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|2.51|||||TWO_SIDED|90.0|2.06|3.06|||||LS mean ratio was calculated from ANOVA model.|||3.06|2.06|
91568471|NCT02341599|183025814|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.989|||||TWO_SIDED|90.0|0.806|1.21|||||LS mean ratio was calculated from ANOVA model.|||1.21|0.806|
91568472|NCT02341599|183025814|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|3.27|||||TWO_SIDED|90.0|2.67|4.02|||||LS mean ratio was calculated from ANOVA model.|||4.02|2.67|
91568473|NCT02341599|183025814|OTHER|LS mean ratio of Group E: Period 1/Group E: Period 2|LS mean ratio|0.299|||||TWO_SIDED|90.0|0.236|0.378|||||LS mean ratio was calculated from ANOVA model.|||0.378|0.236|
91568474|NCT02341599|183025815|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.04|||||TWO_SIDED|90.0|0.846|1.27|||||LS mean ratio was calculated from ANOVA model.|||1.27|0.846|
91568475|NCT02341599|183025815|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|0.524|||||TWO_SIDED|90.0|0.428|0.641|||||LS mean ratio was calculated from ANOVA model.|||0.641|0.428|
91568476|NCT02341599|183025815|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|0.678|||||TWO_SIDED|90.0|0.554|0.831|||||LS mean ratio was calculated from ANOVA model.|||0.831|0.554|
91568477|NCT02341599|183025815|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.273|||||TWO_SIDED|90.0|0.221|0.336|||||LS mean ratio was calculated from ANOVA model.|||0.336|0.221|
91568478|NCT02341599|183025815|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|0.326|||||TWO_SIDED|90.0|0.265|0.402|||||LS mean ratio was calculated from ANOVA model.|||0.402|0.265|
91568479|NCT02341599|183025815|OTHER|LS mean ratio of Group E: Period 2/Group E: Period 1|LS mean ratio|0.808|||||TWO_SIDED|90.0|0.65|1.0|||||LS mean ratio was calculated from ANOVA model.|||1.00|0.650|
91568480|NCT00519285|183025824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.3802|TWO_SIDED|95.6|0.822|1.08||A priori threshold for statistical significance was set to 0.044 using the O'Brien-Fleming alpha spending function to account for two interim analyses.|Log Rank|Log rank test stratified on ECOG Performance Status|Hazard ratio (HR) aflibercept versus placebo estimated from a Cox proportional hazard model stratified on ECOG Performance Status|"Null hypothesis: No difference between aflibercept and placebo~The study was designed to provide 90% power to detect a 1.25-fold increase in median survival with aflibercept compared to placebo at a overall one-sided significance level of 0.025 with 873 deaths."||1.08|0.822|0.3802
91568481|NCT02970305|183025835|SUPERIORITY||Difference in MMRM LSMs|-1.9|STANDARD_ERROR_OF_MEAN|0.95||0.0434|TWO_SIDED|95.0|-3.8|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-3.8|0.0434
91568482|NCT01355471|183025916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimation Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
91568483|NCT02979613|183025923|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|2.0|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.||2.0|-1.9|
91568484|NCT02979613|183025924|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|1.9|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||1.9|-1.9|
91568485|NCT02979613|183025924|SUPERIORITY|||||||0.9953||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.9953
91568486|NCT02979613|183025925|NON_INFERIORITY|Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-3.7|3.7|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||3.7|-3.7|
91568487|NCT02979613|183025925|SUPERIORITY|||||||0.98||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.98
91568488|NCT02979613|183025927|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.9|||||TWO_SIDED|95.0|-3.5|5.2|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||5.2|-3.5|
91568489|NCT02979613|183025927|SUPERIORITY|||||||0.6863||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.6863
91568490|NCT02979613|183025929|SUPERIORITY||Difference in the Percentages|1.4||||0.7258|TWO_SIDED|95.0|-7.2|10.1||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||10.1|-7.2|0.7258
91568491|NCT02979613|183025930|SUPERIORITY||Difference in the Percentages|2.7||||0.1348|TWO_SIDED|95.0|-2.3|7.7||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||7.7|-2.3|0.1348
91568492|NCT02979613|183025931|SUPERIORITY||Difference in the Percentages|9.0||||0.1005|TWO_SIDED|95.0|-2.0|20.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||20.1|-2.0|0.1005
91568493|NCT02979613|183025932|SUPERIORITY||Difference in the Percentages|2.5||||0.4154|TWO_SIDED|95.0|-4.5|9.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||9.5|-4.5|0.4154
91568494|NCT02979613|183025933|SUPERIORITY||Difference in the Percentages|-2.0||||0.0281|TWO_SIDED|95.0|-4.4|0.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||0.3|-4.4|0.0281
91568495|NCT02979613|183025935|SUPERIORITY||Difference in the Percentages|-0.8||||0.5373|TWO_SIDED|95.0|-3.7|2.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.1|-3.7|0.5373
91568496|NCT02979613|183025936|SUPERIORITY||Difference in the Percentages|0.4||||0.5845|TWO_SIDED|95.0|-1.7|2.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.5|-1.7|0.5845
91568497|NCT02979613|183025937|SUPERIORITY||Difference in the Percentages|4.5||||0.1405|TWO_SIDED|95.0|-1.6|10.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||10.6|-1.6|0.1405
91568498|NCT02979613|183025937|SUPERIORITY||Difference in the Percentages|3.8||||0.3133|TWO_SIDED|95.0|-3.7|11.4||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||11.4|-3.7|0.3133
91568499|NCT02979613|183025938|SUPERIORITY||Difference in the Percentages|14.1||||0.3381|TWO_SIDED|95.0|-16.4|44.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory criteria||44.6|-16.4|0.3381
91568500|NCT02979613|183025938|SUPERIORITY||Difference in the Percentages|23.8||||0.0136|TWO_SIDED|95.0|5.3|42.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||42.3|5.3|0.0136
91568501|NCT02979613|183025939|SUPERIORITY||Difference in the Percentages|-2.9||||0.2803|TWO_SIDED|95.0|-8.4|2.6||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||2.6|-8.4|0.2803
91568502|NCT02979613|183025939|SUPERIORITY||Difference in the Percentages|-5.9||||0.0788|TWO_SIDED|95.0|-12.6|0.7||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.7|-12.6|0.0788
91568503|NCT02979613|183025940|SUPERIORITY||Difference in the Percentages|-23.9||||0.088|TWO_SIDED|95.0|-51.2|3.4||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||3.4|-51.2|0.0880
91568504|NCT02979613|183025940|SUPERIORITY||Difference in the Percentages|-18.6||||0.051|TWO_SIDED|95.0|-37.4|0.2||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.2|-37.4|0.0510
91568505|NCT02979613|183025941|SUPERIORITY||Difference in LSM|-0.02||||0.0186|TWO_SIDED|95.0|-0.03|0.0|||ANOVA|||P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (\< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.00|-0.03|0.0186
91568506|NCT02979613|183025942|SUPERIORITY||Difference in LSM|0.0||||0.6956|TWO_SIDED|95.0|-0.02|0.01|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.01|-0.02|0.6956
91568507|NCT02979613|183025943|SUPERIORITY||Difference in LSM|1.167|||<|0.0001|TWO_SIDED|95.0|0.797|1.536|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.536|0.797|< 0.0001
91568508|NCT02979613|183025944|SUPERIORITY||Difference in LSM|0.977||||0.0002|TWO_SIDED|95.0|0.465|1.49|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.490|0.465|0.0002
91568509|NCT02979613|183025945|SUPERIORITY||Difference in LSM|1.881|||<|0.0001|TWO_SIDED|95.0|1.275|2.486|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||2.486|1.275|< 0.0001
91568510|NCT02979613|183025946|SUPERIORITY||Difference in LSM|0.604||||0.097|TWO_SIDED|95.0|-0.11|1.317|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.317|-0.110|0.0970
91568511|NCT02979613|183025947|SUPERIORITY||||||<|0.0001||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||< 0.0001
91568512|NCT02979613|183025948|SUPERIORITY|||||||0.7535||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||0.7535
91568513|NCT02820597|183026011|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.||Null hypothesis is that the within-participant change from baseline in rTNSS is 0.||||<0.001
91568514|NCT02820597|183026012|SUPERIORITY||||||<|0.001||||||Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.|t-test, 2 sided|||Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.||||<0.001
91568515|NCT00337285|183026069|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
91568516|NCT00337285|183026071|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
91568517|NCT01983553|183026076|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.93|||||TWO_SIDED|95.0|0.64|1.36|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Any of the 4 Serotypes||1.36|0.64|
91568518|NCT01983553|183026076|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.96|||||TWO_SIDED|95.0|0.44|2.21|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 1||2.21|0.44|
91568519|NCT01983553|183026076|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.326|||||TWO_SIDED|95.0|0.64|2.94|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 2||2.94|0.64|
91568520|NCT01983553|183026076|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.056|||||TWO_SIDED|95.0|0.48|2.51|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 3||2.51|0.48|
91568521|NCT01983553|183026076|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.629|||||TWO_SIDED|95.0|0.27|1.47|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 4||1.47|0.27|
91568522|NCT01983553|183026076|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|1.22|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Unserotyped||1.22|0.00|
91568523|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.411|||||TWO_SIDED|95.0|0.64|3.42|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Any Serotype||3.42|0.64|
91568524|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.807|||||TWO_SIDED|95.0|0.53|1.25|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Any Serotype||1.25|0.53|
91568525|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|4.885|||||TWO_SIDED|95.0|0.7|212.02|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 1||212.02|0.70|
91568526|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.557|||||TWO_SIDED|95.0|0.21|1.46|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 1||1.46|0.21|
91568527|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|2.931|||||TWO_SIDED|95.0|0.36|134.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 2||134.83|0.36|
91568528|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.165|||||TWO_SIDED|95.0|0.53|2.74|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 2||2.74|0.53|
91568529|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.221|||||TWO_SIDED|95.0|0.2|12.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 3||12.83|0.20|
91568530|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.013|||||TWO_SIDED|95.0|0.41|2.73|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 3||2.73|0.41|
91568531|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.977|||||TWO_SIDED|95.0|0.21|6.04|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 4||6.04|0.21|
91568532|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.506|||||TWO_SIDED|95.0|0.18|1.44|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 4||1.44|0.18|
91568533|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.6|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Unserotyped||2.60|0.00|
91568534|NCT01983553|183026079|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.75|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Unserotyped||19.75|0.00|
91568535|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.174|||||TWO_SIDED|95.0|0.27|7.03|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Any grade||7.03|0.27|
91568536|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade I||4.83|0.00|
91568537|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|2.012|||||TWO_SIDED|95.0|0.2|99.1|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade II||99.10|0.20|
91568538|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Any grade||39.49|0.01|
91568539|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Grade I||39.49|0.01|
91568540|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Any grade||4.83|0.00|
91568541|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.62|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade I||19.62|0.00|
91568542|NCT01983553|183026087|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade II||39.49|0.01|
91568543|NCT00594178|183026090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-250.8||||0.318|TWO_SIDED|95.0|-778.87|277.21|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.||277.21|-778.87|.318
91568544|NCT00594178|183026091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0645||||0.011|TWO_SIDED|95.0|0.01827|0.11073|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.||.11073|.01827|.011
91568545|NCT05215418|183026092|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.001|||||||ANCOVA|||||||< 0.001
91568546|NCT05215418|183026092|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0059|||||||ANCOVA|||||||0.0059
91568547|NCT05215418|183026092|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.1867|||||||ANCOVA|||||||0.1867
91568548|NCT05215418|183026093|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0277|||||||ANCOVA|||||||0.0277
91568549|NCT05215418|183026093|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0852|||||||ANCOVA|||||||0.0852
91568550|NCT05215418|183026093|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.0001|||||||ANCOVA|||||||<.0001
91568551|NCT05215418|183026094|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0109|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0109
91568552|NCT05215418|183026094|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0339|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0339
91568553|NCT05215418|183026094|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.6769|||||||ANCOVA|||In-clinic systolic blood pressure||||0.6769
91568554|NCT05215418|183026094|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0082|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0082
91568555|NCT05215418|183026094|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.8131|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.8131
91568556|NCT05215418|183026094|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.015|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0150
91568557|NCT02971228|183026188|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-6.9||||0.2518|TWO_SIDED|95.0|-19.63|5.84|||t-test, 2 sided||The estimated mean difference is based on the difference between the mean values for 10 patients in the ZP4207 group (12.78) and the matching 10 patients in the Lilly glucagon group (19.67)|A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||5.84|-19.63|0.2518
91568558|NCT02971228|183026188|OTHER||Median Difference (Final Values)|-8.02||||0.25|TWO_SIDED|95.0|-25.85|10.68|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||10.68|-25.85|0.2500
91568559|NCT02971228|183026189|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-0.28||||0.8508|TWO_SIDED|95.0|-3.55|2.99|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||2.99|-3.55|0.8508
91568560|NCT02971228|183026189|OTHER||Median Difference (Final Values)|0.03|||>|0.9999|TWO_SIDED|95.0|-4.12|3.13|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.13|-4.12|>0.9999
91568561|NCT02971228|183026190|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|0.63||||0.1847|TWO_SIDED|95.0|-0.36|1.62|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||1.62|-0.36|0.1847
91568562|NCT02971228|183026190|OTHER||Median Difference (Final Values)|0.02||||0.0781|TWO_SIDED|95.0|-0.01|3.09|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.09|-0.01|0.0781
91568563|NCT00726713|183026205|SUPERIORITY_OR_OTHER||||||=|0.013|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.013
91568564|NCT00726713|183026205|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 24||||=0.033
91568565|NCT00726713|183026206|SUPERIORITY_OR_OTHER||||||=|0.027|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.027
91568566|NCT00726713|183026207|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 16||||=0.0001
91568567|NCT00726713|183026207|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 24||||=0.0001
91568568|NCT00726713|183026207|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from Baseline Week 16||||=0.0001
91568569|NCT00726713|183026207|SUPERIORITY_OR_OTHER||||||=|0.0008|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from BL, Week 24||||=0.0008
91568570|NCT00726713|183026207|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Homocysteine, Change from BL, Week 16||||=0.0001
91568571|NCT00726713|183026207|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total Homocysteine, Change from BL, Week 24||||=0.0001
91568572|NCT00726713|183026208|SUPERIORITY_OR_OTHER||||||=|0.0306||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||SF-36 MCS, Change from BL, Week 24||||=0.0306
91568573|NCT00726713|183026211|SUPERIORITY_OR_OTHER||||||=|0.054|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||HADS Depression, Change from BL, Week 24||||=0.054
91568574|NCT00129649|183026230|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
91568575|NCT02547441|183026232|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
91568576|NCT02547441|183026233|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.019
91568577|NCT01322009|183026239|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Analysis run over study period but data entered only for the 6 h time point||||||>0.05
91568578|NCT01657877|183026242|NON_INFERIORITY_OR_EQUIVALENCE|The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be \<= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice.|Adjusted mean difference|-2.23||||0.2601|TWO_SIDED|95.0|-6.11|1.66|||ANOVA|Based on the mixed effects ANOVA considering treatment and study period as factors, and subject as random effect|Difference is 1500 ppm fluoride as SMFP and 0 % CSP minus 1500 ppm fluoride as SMFP and 5 % CSP such that a positive difference favors 1500 ppm fluoride as SMFP and 0 % CSP|The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.||1.66|-6.11|0.2601
91568579|NCT00846768|183026288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3011||95.0|-0.014|0.044|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.044|-0.014|0.3011
91568580|NCT00846768|183026288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.015||0.1582||95.0|-0.008|0.05|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.050|-0.008|0.1582
91568581|NCT00846768|183026288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.015||0.0003||95.0|0.025|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.083|0.025|0.0003
91568582|NCT00846768|183026288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.7046||95.0|-0.034|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.023|-0.034|0.7046
91568583|NCT00846768|183026288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.015||0.0248||95.0|0.004|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.063|0.004|0.0248
91568584|NCT00846768|183026289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.015||0.0006||95.0|-0.081|-0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.023|-0.081|0.0006
91568585|NCT00846768|183026289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.015||0.0019||95.0|-0.076|-0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.017|-0.076|0.0019
91568586|NCT00846768|183026289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.015||0.4111||95.0|-0.041|0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.017|-0.041|0.4111
91568587|NCT00846768|183026289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.709||95.0|-0.035|0.024|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.024|-0.035|0.7090
91568588|NCT00846768|183026289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.015||0.0211||95.0|0.005|0.064|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.064|0.005|0.0211
91568589|NCT00846768|183026290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.014||0.1753||95.0|-0.045|0.008|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.008|-0.045|0.1753
91568590|NCT00846768|183026290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.014||0.3444||95.0|-0.04|0.014|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.014|-0.040|0.3444
91568591|NCT00846768|183026290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.014||0.1161||95.0|-0.005|0.049|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.049|-0.005|0.1161
91568592|NCT00846768|183026290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.014||0.6789||95.0|-0.033|0.021|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.021|-0.033|0.6789
91568593|NCT00846768|183026290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.014||0.0129||95.0|0.007|0.062|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.062|0.007|0.0129
91568594|NCT00846768|183026291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.017||0.4931||95.0|-0.023|0.047|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.047|-0.023|0.4931
91568595|NCT00846768|183026291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.2597||95.0|-0.015|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.054|-0.015|0.2597
91568596|NCT00846768|183026291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.018||0.0006||95.0|0.027|0.097|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.097|0.027|0.0006
91568597|NCT00846768|183026291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6578||95.0|-0.042|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.027|-0.042|0.6578
91568598|NCT00846768|183026291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.0175||95.0|0.008|0.077|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.077|0.008|0.0175
91568599|NCT00846768|183026292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.02||0.0353||95.0|-0.081|-0.003|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.003|-0.081|0.0353
91568600|NCT00846768|183026292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2875||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.018|-0.060|0.2875
91568601|NCT00846768|183026292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02||0.4553||95.0|-0.024|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.054|-0.024|0.4553
91568602|NCT00846768|183026292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2902||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.018|-0.060|0.2902
91568603|NCT00846768|183026292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.02||0.0731||95.0|-0.003|0.075|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.075|-0.003|0.0731
91568604|NCT00846768|183026293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.027||0.0917||95.0|-0.008|0.099|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.099|-0.008|0.0917
91568605|NCT00846768|183026293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.027||0.1273||95.0|-0.012|0.095|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.095|-0.012|0.1273
91568606|NCT00846768|183026293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.027||0.008||95.0|0.019|0.127|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.127|0.019|0.0080
91568607|NCT00846768|183026293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8683||95.0|-0.049|0.058|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.058|-0.049|0.8683
91568608|NCT00846768|183026293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.027||0.2444||95.0|-0.022|0.086|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.086|-0.022|0.2444
91568609|NCT00846768|183026294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.032||0.0023||95.0|-0.162|-0.036|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.036|-0.162|0.0023
91568610|NCT00846768|183026294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.032||0.0015||95.0|-0.165|-0.04|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.040|-0.165|0.0015
91568611|NCT00846768|183026294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.032||0.4508||95.0|-0.087|0.039|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.039|-0.087|0.4508
91568612|NCT00846768|183026294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||0.9087||95.0|-0.059|0.066|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.066|-0.059|0.9087
91568613|NCT00846768|183026294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.032||0.0146||95.0|0.016|0.142|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.142|0.016|0.0146
91568614|NCT00846768|183026295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3291||95.0|-0.08|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.027|-0.080|0.3291
91568615|NCT00846768|183026295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.027||0.2638||95.0|-0.084|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.023|-0.084|0.2638
91568616|NCT00846768|183026295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3386||95.0|-0.028|0.08|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.080|-0.028|0.3386
91568617|NCT00846768|183026295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8877||95.0|-0.05|0.057|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.057|-0.050|0.8877
91568618|NCT00846768|183026295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0402||95.0|0.003|0.111|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.111|0.003|0.0402
91568619|NCT00846768|183026296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.034||0.0133||95.0|0.018|0.151|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.151|0.018|0.0133
91568620|NCT00846768|183026296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.034||0.045||95.0|0.002|0.135|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.135|0.002|0.0450
91568621|NCT00846768|183026296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0078||95.0|0.025|0.159|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.159|0.025|0.0078
91568622|NCT00846768|183026296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.034||0.6268||95.0|-0.05|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.083|-0.050|0.6268
91568623|NCT00846768|183026296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.034||0.4891||95.0|-0.044|0.091|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.091|-0.044|0.4891
91568624|NCT00846768|183026297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6259||95.0|-0.097|0.059|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.059|-0.097|0.6259
91568625|NCT00846768|183026297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.039||0.919||95.0|-0.082|0.074|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.074|-0.082|0.9190
91568626|NCT00846768|183026297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.04||0.0985||95.0|-0.012|0.145|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.145|-0.012|0.0985
91568627|NCT00846768|183026297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.039||0.6991||95.0|-0.093|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.063|-0.093|0.6991
91568628|NCT00846768|183026297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0802||95.0|-0.009|0.149|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.149|-0.009|0.0802
91568629|NCT04353817|183026333|SUPERIORITY||Least Squares (LS) Mean Difference|-2.26|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.81|||Mixed-effects Model for Repeated Measure|||||-1.81|-2.71|<0.0001
91568630|NCT04353817|183026334|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-47.1||This is the nominal p-value without multiplicity controlled.|Mixed-effects Model for Repeated Measure|||||-47.1|-55.3|<0.0001
91568631|NCT02143063|183026341|SUPERIORITY||comparison of rank sum|3752.0||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
91568632|NCT02143063|183026341|SUPERIORITY||comparison of rank sum|5287.5||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
91568633|NCT02143063|183026342|SUPERIORITY||comparison of rank sum|3675.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Primary Aim 1: Compare the standard care and standard care plus traditional CM conditions||||.02
91568634|NCT02143063|183026342|SUPERIORITY||comparison of rank sum|5189.5||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.61
91568635|NCT00859976|183026384|SUPERIORITY|A superiority test was used to calculate the number of patients that are needed in order to show a difference between the bone mineral density surrounding BoneMaster coated cups compared to plasma HA sprayed cups.||||||0.457|||||||Wilcoxon (Mann-Whitney)|Change in bone mineral density, normalised to baseline levels.||||||0.4570
91568636|NCT02864342|183026399|OTHER||||||<|0.001|||||||Satterthwaite t-test|||The effect of medication reminders on Symbicort adherence was evaluated using a t-test. The equality of variances was also tested and as the variances were not equal, the Satterthwaite-t test was reported.||||<0.001
91568637|NCT01161628|183026425|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: p (CR rate) is 0.5 or less versus... Alternative hypothesis: p \>0.5 A sample size of 25 patients gives 90% power with an alpha = 0.05||||<0.5
91568638|NCT01125566|183026438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4224||95.0|0.87|1.41||Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|||1.41|0.87|0.4224
91568639|NCT01125566|183026439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.024|TWO_SIDED|95.0|1.03|1.63||Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.63|1.03|0.0240
91568640|NCT01125566|183026440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6431||95.0|0.756|1.572|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.572|0.756|0.6431
91568641|NCT01125566|183026441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.029||||0.8829||95.0|0.707|1.496|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.496|0.707|0.8829
91568642|NCT01424189|183026447|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.013|||ONE_SIDED|95.0||0.03||||||||0.030||
91568643|NCT01424189|183026448|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.015|||ONE_SIDED|95.0||-0.017||||||||-0.017||
91568644|NCT00513461|183026453|SUPERIORITY||Mean Difference (Net)|7.78||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.160
91568645|NCT00513461|183026466|SUPERIORITY||Mean Difference (Net)|0.43||||0.878|TWO_SIDED||||||Two-Group t-test|||||||0.878
91568646|NCT00513461|183026467|SUPERIORITY||Mean Difference (Net)|-3.66||||0.212|TWO_SIDED||||||Two-Group t-test|||||||0.212
91568647|NCT00312845|183026476|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
91568648|NCT00312845|183026477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91568649|NCT01123512|183026503|NON_INFERIORITY_OR_EQUIVALENCE|"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|% Probability of Equivalence = 99.92|99.92|||||TWO_SIDED|||||"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|Bayesian test of proportions|||||||
91568650|NCT00496834|183026515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -1.5m/s|Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|1.43|||TWO_SIDED|95.0|-0.83|0.01|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).||0.01|-0.83|
91568651|NCT00496834|183026516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin=-1.5m/s|Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|1.4|||TWO_SIDED|95.0|-0.86|0.15|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||0.15|-0.86|
91568652|NCT00496834|183026517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9032||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test.||||||0.9032
91568653|NCT00496834|183026518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test||||||0.6574
91568654|NCT01227928|183026531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.595|1.626|||||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.|||1.626|0.595|
91568655|NCT01227928|183026532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811||||0.5901|TWO_SIDED|95.0|0.376|1.751|||Log Rank||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.|||1.751|0.376|0.5901
91568656|NCT01042145|183026546|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
91568657|NCT01042145|183026547|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.63
91568658|NCT01042145|183026549|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.51
91568659|NCT01042145|183026550|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
91568660|NCT01042145|183026551|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
91568661|NCT04088136|183026552|EQUIVALENCE|A one-tailed independent samples t-test was conducted. A p-value of .05 was used to determine statistical significance.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.67|TWO_SIDED|95.0|-0.42|0.55|||t-test, 2 sided|Use of pooled error term, df = 60.|Negative number reflects fewer errors in EMMI group, as predicted.|||0.55|-0.42|.67
91568662|NCT04088136|183026553|SUPERIORITY|Everyday Metacognitive Memory group predicted to have superior scores to Memory Strategy Control|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.47|TWO_SIDED||||||t-test, 1 sided||pooled error term, equal variance assumption, df = 60|||||<.47
91568663|NCT04088136|183026554|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.0|<|0.13|TWO_SIDED|95.0|-3.7|7.6|||t-test, 1 sided|||||7.6|-3.7|< .13
91568664|NCT04088136|183026555|EQUIVALENCE|Directional hypothesis of fewer errors in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.8||0.57|TWO_SIDED|95.0|-4.8|2.6||A p-value of .05 was used to determine statistical significance.|t-test, 2 sided|Pooled error term, df = 51||||2.6|-4.8|.57
91568665|NCT04088136|183026556|EQUIVALENCE|Two-tailed test of hypothesis of fewer errors in EMMI group|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.3||0.72|TWO_SIDED|95.0|-3.8|5.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Pooled error term, df = 49||||5.5|-3.8|.72
91568666|NCT04088136|183026557|OTHER|Test of Group X Time interaction|||||<|0.69|||||||Mixed Models Analysis|pooled df = 59||"We ran a 2 X 2 (Group X Time) mixed model analysis with repeated measures on Time (pretest, posttest).~Hypothesis was that Memory Strategy Control group would show greater improvements from pretest to posttest in recall scores"||||< .69
91568667|NCT04088136|183026558|OTHER|One-tailed test of Group X Time interaction|||||<|0.037|||||||Mixed Models Analysis|||"We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest).~Predicted hypothesis was greater pretest-posttest improvement in the Memory Strategy Contol group"||||< .037
91568668|NCT04088136|183026559|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|9.9||0.69|TWO_SIDED|95.0|-4.0|8.4|||t-test, 2 sided||one instance of missing data due to computer failure during testing. Pooled error term resulting in df = 59|||8.4|-4.0|.69
91568669|NCT04088136|183026560|EQUIVALENCE|Directional hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|103.3||0.63|TWO_SIDED|95.0|-257.4|157.4||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, DF = 51||||157.4|-257.4|.63
91568670|NCT04088136|183026561|EQUIVALENCE|Two-tailed test of hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|43.8||0.81|TWO_SIDED|95.0|-77.4|98.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, df = 49||||98.5|-77.4|.81
91568671|NCT04088136|183026562|OTHER||||||<|0.14|||||||Mixed Models Analysis|mixed procedure with unrestricted error covariance matrix. Pooled df for MSWithin = 60||We conducted a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater reduction in memory complaints from pretest to posttest in EMMI group||||< .14
91568672|NCT04088136|183026563|OTHER|||||||0.037|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest)||||.037
91568673|NCT04088136|183026564|OTHER|Hypothesis was greater increase in memory self-efficacy for Everyday Metacognitive Memory group|||||<|0.33|||||||Mixed Models Analysis|mixed model specified unrestricted residual (error) covariance matrix. Pooled df in MS Error = 60||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest).||||< .33
91568674|NCT04088136|183026565|OTHER||||||<|0.2|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater increase in memory control in EMMI group||||< .20
91568675|NCT04088136|183026566|OTHER|Hypothesis was greater increase in use of external mnemonics in EMMI group|||||<|0.2|||||||Mixed Models Analysis|||||||< .20
91568676|NCT01494298|183026567|SUPERIORITY_OR_OTHER||||||=|0.002||95.0||||The control group average age was 6 years lower(P=0.001). Results were adjusted via a logistic regression and presented as age-adjusted means and SE. The unadjusted differences had similar results.|t-test, 2 sided|||Hypothesis - There will be differences in ApoB between AA with T2DM and those without. To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05. Continuous data were compared using a Students t-test and categorical data were compared using test.||||=0.002
91568677|NCT01494298|183026569|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 2 sided|||||||0.84
91568678|NCT04159805|183026571|SUPERIORITY||Difference in Least Square (LS) Mean|0.29|||=|0.772|TWO_SIDED|95.0|-1.72|2.3||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.30|-1.72|=0.772
91568679|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|1.01|||=|0.299|TWO_SIDED|95.0|-0.94|2.97||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.97|-0.94|=0.299
91568680|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|-0.11|||=|0.924|TWO_SIDED|95.0|-2.34|2.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.13|-2.34|=0.924
91568681|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|1.86|||=|0.091|TWO_SIDED|95.0|-0.32|4.04||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.04|-0.32|=0.091
91568682|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|-0.18|||=|0.887|TWO_SIDED|95.0|-2.82|2.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-2.82|=0.887
91568683|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|1.8|||=|0.162|TWO_SIDED|95.0|-0.76|4.36||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.36|-0.76|=0.162
91568684|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|-0.36|||=|0.784|TWO_SIDED|95.0|-3.01|2.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||2.29|-3.01|=0.784
91568685|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|1.79|||=|0.166|TWO_SIDED|95.0|-0.79|4.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||4.37|-0.79|=0.166
91568686|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|0.42|||=|0.724|TWO_SIDED|95.0|-1.98|2.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.82|-1.98|=0.724
91568687|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|1.81|||=|0.124|TWO_SIDED|95.0|-0.52|4.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.14|-0.52|=0.124
91568688|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|0.29|||=|0.856|TWO_SIDED|95.0|-2.91|3.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||3.48|-2.91|=0.856
91568689|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|1.64|||=|0.292|TWO_SIDED|95.0|-1.48|4.76||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.76|-1.48|=0.292
91568690|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|0.11|||=|0.944|TWO_SIDED|95.0|-3.14|3.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.37|-3.14|=0.944
91568691|NCT04159805|183026571|SUPERIORITY||Difference in LS Mean|0.85|||=|0.589|TWO_SIDED|95.0|-2.33|4.02||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||4.02|-2.33|=0.589
91568692|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-0.93|||=|0.406|TWO_SIDED|95.0|-3.17|1.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||1.31|-3.17|=0.406
91568693|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|0.9|||=|0.418|TWO_SIDED|95.0|-1.34|3.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.14|-1.34|=0.418
91568694|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.463|TWO_SIDED|95.0|-3.53|1.65||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||1.65|-3.53|=0.463
91568695|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-0.1|||=|0.936|TWO_SIDED|95.0|-2.7|2.49||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.49|-2.70|=0.936
91568696|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-1.8|||=|0.17|TWO_SIDED|95.0|-4.41|0.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||0.82|-4.41|=0.170
91568697|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|0.52|||=|0.687|TWO_SIDED|95.0|-2.1|3.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.13|-2.10|=0.687
91568698|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-1.24|||=|0.374|TWO_SIDED|95.0|-4.05|1.57||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||1.57|-4.05|=0.374
91568699|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|0.99|||=|0.478|TWO_SIDED|95.0|-1.82|3.8||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.80|-1.82|=0.478
91568700|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-0.51|||=|0.69|TWO_SIDED|95.0|-3.12|2.09||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.09|-3.12|=0.690
91568701|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|2.12|||=|0.106|TWO_SIDED|95.0|-0.48|4.71||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.71|-0.48|=0.106
91568702|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-0.89|||=|0.547|TWO_SIDED|95.0|-3.89|2.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||2.12|-3.89|=0.547
91568703|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|2.19|||=|0.144|TWO_SIDED|95.0|-0.81|5.18||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.18|-0.81|=0.144
91568704|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|-1.37|||=|0.431|TWO_SIDED|95.0|-4.91|2.17||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||2.17|-4.91|=0.431
91568705|NCT04159805|183026572|SUPERIORITY||Difference in LS Mean|1.2|||=|0.488|TWO_SIDED|95.0|-2.34|4.74|||MMRM|||Change From Baseline at Week 16||4.74|-2.34|=0.488
91568706|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|-0.34|||=|0.855|TWO_SIDED|95.0|-4.14|3.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.45|-4.14|=0.855
91568707|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|3.19|||=|0.093|TWO_SIDED|95.0|-0.56|6.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||6.95|-0.56|=0.093
91568708|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|1.8|||=|0.41|TWO_SIDED|95.0|-2.61|6.2||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.20|-2.61|=0.410
91568709|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|3.13|||=|0.154|TWO_SIDED|95.0|-1.25|7.5||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||7.50|-1.25|=0.154
91568710|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.662|TWO_SIDED|95.0|-5.29|3.41||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.41|-5.29|=0.662
91568711|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|3.26|||=|0.13|TWO_SIDED|95.0|-1.02|7.54||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||7.54|-1.02|=0.130
91568712|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|1.27|||=|0.586|TWO_SIDED|95.0|-3.44|5.98||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||5.98|-3.44|=0.586
91568713|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|4.93|||=|0.039|TWO_SIDED|95.0|0.26|9.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||9.60|0.26|=0.039
91568714|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|-0.22|||=|0.909|TWO_SIDED|95.0|-4.03|3.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.60|-4.03|=0.909
91568715|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|2.65|||=|0.158|TWO_SIDED|95.0|-1.09|6.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||6.40|-1.09|=0.158
91568716|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|-0.88|||=|0.764|TWO_SIDED|95.0|-6.8|5.05||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.05|-6.80|=0.764
91568717|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|5.2|||=|0.08|TWO_SIDED|95.0|-0.67|11.06||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||11.06|-0.67|=0.080
91568718|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|-1.01|||=|0.677|TWO_SIDED|95.0|-5.98|3.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.95|-5.98|=0.677
91568719|NCT04159805|183026573|SUPERIORITY||Difference in LS Mean|4.81|||=|0.055|TWO_SIDED|95.0|-0.1|9.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||9.73|-0.10|=0.055
91568720|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|0.52|||=|0.78|TWO_SIDED|95.0|-3.23|4.27||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.27|-3.23|=0.780
91568721|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|0.5|||=|0.771|TWO_SIDED|95.0|-2.99|3.99||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.99|-2.99|=0.771
91568722|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-0.04|||=|0.984|TWO_SIDED|95.0|-4.22|4.14||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.14|-4.22|=0.984
91568723|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|2.44|||=|0.213|TWO_SIDED|95.0|-1.47|6.35||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.35|-1.47|=0.213
91568724|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-1.97|||=|0.371|TWO_SIDED|95.0|-6.4|2.45||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-6.40|=0.371
91568725|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|0.11|||=|0.956|TWO_SIDED|95.0|-4.01|4.23||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.23|-4.01|=0.956
91568726|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-1.06|||=|0.641|TWO_SIDED|95.0|-5.65|3.53||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.53|-5.65|=0.641
91568727|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-0.33|||=|0.876|TWO_SIDED|95.0|-4.61|3.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.95|-4.61|=0.876
91568728|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-1.86|||=|0.458|TWO_SIDED|95.0|-6.91|3.18||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.18|-6.91|=0.458
91568729|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-0.68|||=|0.769|TWO_SIDED|95.0|-5.37|4.0||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.00|-5.37|=0.769
91568730|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|-1.14|||=|0.699|TWO_SIDED|95.0|-7.07|4.8||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.80|-7.07|=0.699
91568731|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|1.1|||=|0.687|TWO_SIDED|95.0|-4.41|6.62||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||6.62|-4.41|=0.687
91568732|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|0.2|||=|0.944|TWO_SIDED|95.0|-5.55|5.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||5.95|-5.55|=0.944
91568733|NCT04159805|183026574|SUPERIORITY||Difference in LS Mean|2.48|||=|0.351|TWO_SIDED|95.0|-2.87|7.83||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||7.83|-2.87|=0.351
91568734|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-27.9|||=|0.09|TWO_SIDED|95.0|-60.18|4.38||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||4.38|-60.18|=0.090
91568735|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-15.77|||=|0.328|TWO_SIDED|95.0|-47.5|15.96||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||15.96|-47.50|=0.328
91568736|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-12.65|||=|0.441|TWO_SIDED|95.0|-44.94|19.63||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||19.63|-44.94|=0.441
91568737|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|1.39|||=|0.931|TWO_SIDED|95.0|-30.33|33.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||33.12|-30.33|=0.931
91568738|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-28.18|||=|0.087|TWO_SIDED|95.0|-60.46|4.11||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.11|-60.46|=0.087
91568739|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|4.44|||=|0.783|TWO_SIDED|95.0|-27.29|36.16||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||36.16|-27.29|=0.783
91568740|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-29.08|||=|0.077|TWO_SIDED|95.0|-61.36|3.21||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||3.21|-61.36|=0.077
91568741|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-15.72|||=|0.33|TWO_SIDED|95.0|-47.45|16.0||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||16.00|-47.45|=0.330
91568742|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-14.14|||=|0.4|TWO_SIDED|95.0|-47.19|18.91||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||18.91|-47.19|=0.400
91568743|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|0.0|||=|1|TWO_SIDED|95.0|-32.18|32.19||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||32.19|-32.18|=1.000
91568744|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-26.47|||=|0.117|TWO_SIDED|95.0|-59.64|6.69||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||6.69|-59.64|=0.117
91568745|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-12.75|||=|0.436|TWO_SIDED|95.0|-44.94|19.44||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||19.44|-44.94|=0.436
91568746|NCT04159805|183026575|SUPERIORITY|From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|Difference in LS Mean|-47.91|||=|0.005|TWO_SIDED|95.0|-81.54|-14.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||-14.29|-81.54|=0.005
91568747|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-20.48|||=|0.215|TWO_SIDED|95.0|-52.92|11.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||11.95|-52.92|=0.215
91568748|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-3.97|||=|0.815|TWO_SIDED|95.0|-37.34|29.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||29.40|-37.34|=0.815
91568749|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-4.31|||=|0.794|TWO_SIDED|95.0|-36.84|28.22||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||28.22|-36.84|=0.794
91568750|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-36.78|||=|0.033|TWO_SIDED|95.0|-70.48|-3.08||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||-3.08|-70.48|=0.033
91568751|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-10.79|||=|0.513|TWO_SIDED|95.0|-43.26|21.67||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 12||21.67|-43.26|=0.513
91568752|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-56.21|||=|0.002|TWO_SIDED|95.0|-91.69|-20.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-20.73|-91.69|=0.002
91568753|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-36.94|||=|0.036|TWO_SIDED|95.0|-71.39|-2.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-2.48|-71.39|=0.036
91568754|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-62.98|||=|0.001|TWO_SIDED|95.0|-100.64|-25.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||-25.31|-100.64|=0.001
91568755|NCT04159805|183026575|SUPERIORITY||Difference in LS Mean|-28.81|||=|0.13|TWO_SIDED|95.0|-66.12|8.51||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||8.51|-66.12|=0.130
91568756|NCT02930837|183026580|SUPERIORITY||Percentage of patients|63.3|||<|0.0001|TWO_SIDED|95.0|54.42|71.42|||One-sample test||Percentage of patients with Favourable outcome|A null hypothesis of p ≤40% versus the alternative hypothesis of p \>40% was tested using a one sample test at two-sided significance level of 0.05, where p denoted the response rate in Chinese patients who were treated within 3-4.5 h after stroke onset.||71.42|54.42|<0.0001
91568757|NCT01393613|183026587|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.||||0.0093
91568758|NCT01393613|183026587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47||||0.0022|TWO_SIDED|95.0|-10.6|-2.35|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-2.35|-10.6|0.0022
91568759|NCT01393613|183026587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.1448|TWO_SIDED|95.0|-7.23|1.07|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.07|-7.23|0.1448
91568760|NCT01393613|183026587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.37||||0.1588|TWO_SIDED|95.0|-8.06|1.32|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.||1.32|-8.06|0.1588
91568761|NCT01393613|183026588|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6.||||0.0069
91568762|NCT01393613|183026588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0015|TWO_SIDED|95.0|-0.62|-0.15|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. The analysis of this key secondary endpoint was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Because only the comparison of brexpiprazole 4 mg/day vs placebo met the threshold in the primary analysis, the following analysis is not part of the formal statistical testing and is descriptive only.||-0.15|-0.62|0.0015
91568763|NCT01393613|183026588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1269|TWO_SIDED|95.0|-0.42|-0.05|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.05|-0.42|0.1269
91568764|NCT01393613|183026588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.16|-0.37|0.4449
91568765|NCT01393613|183026589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.59||||0.0005|TWO_SIDED|95.0|2.02|7.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||7.17|2.02|0.0005
91568766|NCT01393613|183026589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1286|TWO_SIDED|95.0|-0.58|4.59|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||4.59|-0.58|0.1286
91568767|NCT01393613|183026589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0332|TWO_SIDED|95.0|0.26|6.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||6.16|0.26|0.0332
91568768|NCT01393613|183026590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.0166|TWO_SIDED|95.0|-3.08|-0.31|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.31|-3.08|0.0166
91568769|NCT01393613|183026590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.5101|TWO_SIDED|95.0|-1.86|0.93|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.93|-1.86|0.5101
91568770|NCT01393613|183026590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.3938|TWO_SIDED|95.0|-2.26|0.89|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.89|-2.26|0.3938
91568771|NCT01393613|183026591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0231|TWO_SIDED|95.0|-2.28|-0.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.17|-2.28|0.0231
91568772|NCT01393613|183026591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.1547|TWO_SIDED|95.0|-1.83|0.29|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.29|-1.83|0.1547
91568773|NCT01393613|183026591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2004|TWO_SIDED|95.0|-1.98|0.42|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.42|-1.98|0.2004
91568774|NCT01393613|183026592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0009|TWO_SIDED|95.0|-0.78|-0.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-0.78|0.0009
91568775|NCT01393613|183026592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0422|TWO_SIDED|95.0|-0.6|-0.01|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.01|-0.60|0.0422
91568776|NCT01393613|183026592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.1358|TWO_SIDED|95.0|-0.56|0.08|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.08|-0.56|0.1358
91568777|NCT01393613|183026593|SUPERIORITY_OR_OTHER||Relative Risk|1.54||||0.0006|TWO_SIDED|95.0|1.2|2.0|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||2.00|1.20|0.0006
91568778|NCT01393613|183026593|SUPERIORITY_OR_OTHER||Relative Risk|1.22||||0.168|TWO_SIDED|95.0|0.92|1.62|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.62|0.92|0.1680
91568779|NCT01393613|183026593|SUPERIORITY_OR_OTHER||Relative Risk|1.35||||0.0433|TWO_SIDED|95.0|1.02|1.79|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.79|1.02|0.0433
91568780|NCT01393613|183026594|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.5202|TWO_SIDED|95.0|0.44|1.51|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||1.51|0.44|0.5202
91568781|NCT01393613|183026594|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.9894|TWO_SIDED|95.0|0.55|1.85|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.85|0.55|0.9894
91568782|NCT01393613|183026594|SUPERIORITY_OR_OTHER||Relative Risk|0.76||||0.4586|TWO_SIDED|95.0|0.36|1.59|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.59|0.36|0.4586
91568783|NCT01393613|183026595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0029|TWO_SIDED|95.0|-2.3|-0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.48|-2.30|0.0029
91568784|NCT01393613|183026595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.3559|TWO_SIDED|95.0|-1.34|0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.48|-1.34|0.3559
91568785|NCT01393613|183026595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.3646|TWO_SIDED|95.0|-1.51|0.56|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.56|-1.51|0.3646
91568786|NCT01393613|183026596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1273|TWO_SIDED|95.0|-2.61|0.33|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||0.33|-2.61|0.1273
91568787|NCT01393613|183026596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.64|TWO_SIDED|95.0|-1.83|1.12|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.12|-1.83|0.6400
91568788|NCT01393613|183026596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4423|TWO_SIDED|95.0|-2.32|1.01|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.01|-2.32|0.4423
91568789|NCT01393613|183026597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0194|TWO_SIDED|95.0|-2.36|-0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.21|-2.36|0.0194
91568790|NCT01393613|183026597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0754|TWO_SIDED|95.0|-2.06|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.10|-2.06|0.0754
91568791|NCT01393613|183026597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.108|TWO_SIDED|95.0|-2.22|0.22|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.22|-2.22|0.1080
91568792|NCT01393613|183026598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0045|TWO_SIDED|95.0|-2.34|-0.43|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.||-0.43|-2.34|0.0045
91568793|NCT01393613|183026598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4753|TWO_SIDED|95.0|-1.31|0.61|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.61|-1.31|0.4753
91568794|NCT01393613|183026598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.115|TWO_SIDED|95.0|-1.96|0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.21|-1.96|0.1150
91568795|NCT01393613|183026599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0021|TWO_SIDED|95.0|-2.05|-0.46|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.46|-2.05|0.0021
91568796|NCT01393613|183026599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.6792|TWO_SIDED|95.0|-0.97|0.63|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.63|-0.97|0.6792
91568797|NCT01393613|183026599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.5752|TWO_SIDED|95.0|-1.16|0.65|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.65|-1.16|0.5752
91568798|NCT01393613|183026600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0104|TWO_SIDED|95.0|-1.51|-0.2|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-1.51|0.0104
91568799|NCT01393613|183026600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0373|TWO_SIDED|95.0|-1.35|-0.04|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.04|-1.35|0.0373
91568800|NCT01393613|183026600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.089|TWO_SIDED|95.0|-1.39|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.10|-1.39|0.0890
91568801|NCT00497874|183026653|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.003||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(145) = 2.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.003
91568802|NCT00497874|183026654|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.002||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(181) = 2.9||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.002
91568803|NCT00497874|183026655|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.04||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(153) = 1.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.04
91568804|NCT00497874|183026656|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.07||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(57) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.07
91568805|NCT00497874|183026657|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.05||95.0|||||t-test, 1 sided|t(94) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.05
91568806|NCT00497874|183026658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.13||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(123) = 1.2||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.13
91568807|NCT01664923|183026690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.181|0.32||P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.320|0.181|<0.0001
91568808|NCT01664923|183026691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.137|0.264||P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.264|0.137|<0.0001
91568809|NCT01664923|183026692|SUPERIORITY_OR_OTHER||Difference in rates|50.0|||<|0.0001|TWO_SIDED|95.0|41.4|58.5|||Cochran-Mantel-Haenszel|Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.|Enzalutamide response rate minus bicalutamide response rate.|||58.5|41.4|<0.0001
91568810|NCT01664923|183026693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.0001|TWO_SIDED|95.0|0.211|0.497|||Log Rank|P-value is based on an unstratified log-rank test.|Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.497|0.211|<0.0001
91568811|NCT01664923|183026694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.4945|TWO_SIDED|95.0|0.695|1.192||This secondary endpoint was not adjusted for multiple comparisons.|Log Rank|P-value is based on a log-rank test stratified by disease stage at study entry.|Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||1.192|0.695|0.4945
91568812|NCT01664923|183026695|SUPERIORITY_OR_OTHER||Difference in objective response rate|46.05|||<|0.0001|TWO_SIDED|95.0|26.79|65.3||This secondary endpoint was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Based on unstratified Cochran-Mantel-Haenszel mean score test.||||65.30|26.79|<0.0001
91568813|NCT03398421|183026697|SUPERIORITY||Ratio of adjusted geometric mean|2.005|||||TWO_SIDED|90.0|1.807|2.224||||||||2.224|1.807|
91568814|NCT03398421|183026704|SUPERIORITY||Ratio of adjusted geometric mean|0.802|||||TWO_SIDED|90.0|0.69|0.933||||||||0.933|0.690|
91568815|NCT00878553|183026773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.606|STANDARD_ERROR_OF_MEAN|2.42||0.0118|TWO_SIDED|95.0|-15.284|-1.927||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-1.927|-15.284|0.0118
91568816|NCT00878553|183026773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.98|STANDARD_ERROR_OF_MEAN|2.421||0.0037|TWO_SIDED|95.0|-16.685|-3.275||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-3.275|-16.685|0.0037
91568817|NCT00878553|183026773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.153|STANDARD_ERROR_OF_MEAN|2.422||0.0077|TWO_SIDED|95.0|-15.857|-2.448||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo.|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05.|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 20-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||-2.448|-15.857|0.0077
91568818|NCT00878553|183026774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.604|STANDARD_ERROR_OF_MEAN|2.755||0.1476|TWO_SIDED|95.0|-13.208|2.0||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.000|-13.208|0.1476
91568819|NCT00878553|183026774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.912|STANDARD_ERROR_OF_MEAN|2.757||0.0757|TWO_SIDED|95.0|-14.546|0.722||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||0.722|-14.546|0.0757
91568820|NCT00878553|183026774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.521|STANDARD_ERROR_OF_MEAN|2.757||0.1553|TWO_SIDED|95.0|-13.154|2.113||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.113|-13.154|0.1553
91568821|NCT00878553|183026775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.831|STANDARD_ERROR_OF_MEAN|2.4||0.0092|TWO_SIDED|95.0|2.208|15.454||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||15.454|2.208|0.0092
91568822|NCT00878553|183026775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.425|STANDARD_ERROR_OF_MEAN|2.402||0.0023|TWO_SIDED|95.0|3.775|17.075||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||17.075|3.775|0.0023
91568823|NCT00878553|183026775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.147|STANDARD_ERROR_OF_MEAN|2.402||0.003|TWO_SIDED|95.0|3.498|16.796||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||16.796|3.498|0.0030
91568824|NCT00878553|183026776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.562|STANDARD_ERROR_OF_MEAN|0.244||0.1005|TWO_SIDED|95.0|-1.235|0.11||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||0.110|-1.235|0.1005
91568825|NCT00878553|183026776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.037|STANDARD_ERROR_OF_MEAN|0.244||0.0028|TWO_SIDED|95.0|-1.712|-0.362||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.362|-1.712|0.0028
91568826|NCT00878553|183026776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.793|STANDARD_ERROR_OF_MEAN|0.244||0.0216|TWO_SIDED|95.0|-1.467|-0.118||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustments for multiple testing were made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.118|-1.467|0.0216
91568827|NCT00878553|183026777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.452|STANDARD_ERROR_OF_MEAN|0.219||0.219|TWO_SIDED|95.0|-21.98|5.077||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||5.077|-21.980|0.2190
91568828|NCT00878553|183026777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.365|STANDARD_ERROR_OF_MEAN|4.937||0.8441|TWO_SIDED|95.0|-12.327|15.056||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A positive mean change from baseline indicates a worsening.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||15.056|-12.327|0.8441
91568829|NCT00878553|183026777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.84|STANDARD_ERROR_OF_MEAN|4.936||0.0894|TWO_SIDED|95.0|-25.522|1.842||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||1.842|-25.522|0.0894
91568830|NCT00878553|183026778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.469||0.6433|TWO_SIDED|95.0|-1.823|2.943||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||2.943|-1.823|0.6433
91568831|NCT00878553|183026778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.912|STANDARD_ERROR_OF_MEAN|1.523||0.1167|TWO_SIDED|95.0|-4.304|0.481||Analysis included effects for patient, period, sequence and treatment|Mixed Models Analysis||A negative mean difference from baseline indicates a worsening.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||0.481|-4.304|0.1167
91568832|NCT00878553|183026778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|1.626||0.2385|TWO_SIDED|95.0|-0.958|3.826||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||3.826|-0.958|0.2385
91568833|NCT00878553|183026779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.256||0.0914|TWO_SIDED|95.0|-0.073|0.972|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.972|-0.073|0.0914
91568834|NCT00878553|183026779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.165|STANDARD_ERROR_OF_MEAN|0.259||0.536|TWO_SIDED|95.0|-0.36|0.69|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.690|-0.360|0.5360
91568835|NCT00878553|183026779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|STANDARD_ERROR_OF_MEAN|0.237||0.3254|TWO_SIDED|95.0|-0.787|0.263|||Mixed Models Analysis||A negative mean change from baseline indicates a worsening.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.263|-0.787|0.3254
91568836|NCT00878553|183026780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.818||0.719|TWO_SIDED|95.0|-3.175|4.595||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates improvement.|||4.595|-3.175|0.7190
91568837|NCT00878553|183026780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821|STANDARD_ERROR_OF_MEAN|2.422||0.6784|TWO_SIDED|95.0|-3.08|4.722||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||4.722|-3.080|0.6784
91568838|NCT00878553|183026780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.314|STANDARD_ERROR_OF_MEAN|2.058||0.2433|TWO_SIDED|95.0|-1.586|6.214||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||6.214|-1.586|0.2433
91568839|NCT00878553|183026781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39||||0.0009|TWO_SIDED||||||ANOVA|F-test 2 degrees of freedom||Cmax(ng/mL) \[Maximum plasma zaleplon concentration\]||||0.0009
91568840|NCT00878553|183026782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.9142||95.0|||||ANOVA|F-test two degrees of freedom||Cmax normalized per dose||||0.9142
91568841|NCT00878553|183026783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.24||||0.1193||95.0|||||ANOVA|F-test 2 degrees of freedom||Time (hour)post-dose of maximum plasma zaleplon concentration||||0.1193
91568842|NCT00878553|183026784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.85||||0.0003||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC ng\*h/mL)||||0.0003
91568843|NCT00878553|183026785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.28||||0.2281||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC/Dose (ng\*h/mL/mg)||||0.2281
91568844|NCT00878553|183026786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.4835||95.0|||||ANOVA|2 degrees of freedom F-test||Half-Life (t1/2 in hours) of plasma zaleplon from each of 3 doses of SKP-1041||||0.4835
91568845|NCT00909532|183026793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.6|12.6||The primary and key secondary endpoints were analyzed using Hochberg's step-up procedure: test 1, primary (α=0.05); test 2, CFQ-R resp domain (Wk24) and sweat chloride (Wk24)(α=0.05).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline values of age and percent predicted FEV1.||12.6|8.6|<0.0001
91568846|NCT00909532|183026794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.5|12.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||Analysis of this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were obtained from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for the continuous baseline values of age and percent predicted forced expiratory volume in 1 second (FEV1),using unstructured covariance matrix.||12.5|8.5|<0.0001
91568847|NCT00909532|183026795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|4.7|11.4||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||Through Week 24: Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, domain score, and percent predicted FEV1, using unstructured covariance matrix.||11.4|4.7|<0.0001
91568848|NCT00909532|183026795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|5.3|11.9||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for the CFQ-R respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age,sweat chloride, and percent predicted FEV1,using unstructured covariance matrix.||11.9|5.3|<0.0001
91568849|NCT00909532|183026796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.3|-44.5||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.5|-51.3|<0.0001
91568850|NCT00909532|183026796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.5|-44.7||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.7|-51.5|<0.0001
91568851|NCT00909532|183026797|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at Week 24|0.4||||0.0016|TWO_SIDED|95.0|0.23|0.71||There was no adjustment for multiple comparisons.|Regression, Cox|||Time to first pulmonary exacerbation through Week 24 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.71|0.23|0.0016
91568852|NCT00909532|183026797|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at 48 Weeks|0.46||||0.0012|TWO_SIDED|95.0|0.28|0.73||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Regression, Cox|||Time to first pulmonary exacerbation through Week 48 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.73|0.28|0.0012
91568853|NCT00909532|183026798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed Models Analysis|There was no adjustment for multiple comparisons.||At Week 24: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect, and intercept, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||3.7|1.8|<0.0001
91568854|NCT00909532|183026798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.7||0.0001|TWO_SIDED|95.0|1.3|4.1||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect and visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.1|1.3|0.0001
91568855|NCT00118703|183026817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094||||0.604|TWO_SIDED|95.0|-0.26|0.45|||ANCOVA|The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.||||0.45|-0.26|0.604
91568856|NCT00118703|183026818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.729|TWO_SIDED|95.0|-0.29|0.41|||ANCOVA|The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.||||0.41|-0.29|0.729
91568857|NCT00118703|183026819|SUPERIORITY_OR_OTHER|||||||0.064|||||||Regression, Logistic|Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen||||||0.064
91568858|NCT00461123|183026820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.5248||95.0|-4.18|8.05|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of least squares (LS) means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||8.05|-4.18|0.5248
91568859|NCT00461123|183026821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.87||95.0|-3.58|3.04|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||3.04|-3.58|0.8700
91568860|NCT00461123|183026822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.57||||0.4162||95.0|-8.21|19.35|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||19.35|-8.21|0.4162
91568861|NCT00461123|183026823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0588||95.0|-13.25|0.26|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||0.26|-13.25|0.0588
91568862|NCT00461123|183026824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.7878||95.0|-22.03|16.82|||ANCOVA|Analysis of variance (ANOVA), treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group||16.82|-22.03|0.7878
91568863|NCT00984698|183026833|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
91568864|NCT00984698|183026834|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
91568865|NCT00746356|183026836|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0066|STANDARD_DEVIATION|0.3103|<|0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|<0.0001
91568866|NCT00746356|183026837|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0625|STANDARD_DEVIATION|0.0948||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
91568867|NCT00746356|183026838|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0556|STANDARD_DEVIATION|0.0824||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
91568868|NCT00746356|183026839|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0028|STANDARD_DEVIATION|0.2852||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
91568869|NCT00983892|183026872|SUPERIORITY_OR_OTHER||Slope|-1.56||||0.03|TWO_SIDED|95.0|-2.97|-0.15|||GEE|Adjusting for baseline symptom severity, caregiver type, week number, and cancer site.||||-0.15|-2.97|0.030
91568870|NCT03181282|183026878|SUPERIORITY||Slope|0.0529|STANDARD_ERROR_OF_MEAN|0.0194||0.0194|TWO_SIDED|95.0|0.0132|0.0925|||Mixed Models Analysis|Mixed model analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.0925|0.0132|0.0194
91568871|NCT03181282|183026878|SUPERIORITY||Slope|0.0718|STANDARD_ERROR_OF_MEAN|0.0231||0.004625|TWO_SIDED|95.0|0.0242|0.1194|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation Condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.1194|0.0242|0.004625
91568872|NCT03181282|183026879|SUPERIORITY||Slope|10.5248|STANDARD_ERROR_OF_MEAN|4.8439||0.038389|TWO_SIDED|95.0|0.6038|20.4459|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||20.4459|0.6038|0.038389
91568873|NCT03181282|183026879|SUPERIORITY||Slope|7.7233|STANDARD_ERROR_OF_MEAN|4.668||0.109873|TWO_SIDED|95.0|-1.8652|17.3117|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||17.3117|-1.8652|0.109873
91568874|NCT02484547|183026898|SUPERIORITY||Difference|-0.26||||0.0901|TWO_SIDED|95.0|-0.569|0.041|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.041|-0.569|0.0901
91568875|NCT02484547|183026898|SUPERIORITY||Difference|-0.39||||0.012|TWO_SIDED|95.0|-0.694|-0.086|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit.||-0.086|-0.694|0.0120
91568876|NCT02484547|183026899|SUPERIORITY||Difference|-0.1||||0.7578|TWO_SIDED|95.0|-0.65|0.48|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.48|-0.65|0.7578
91568877|NCT02484547|183026899|SUPERIORITY||Difference|0.6||||0.0493|TWO_SIDED|95.0|0.0|1.13|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.13|0.00|0.0493
91568878|NCT02484547|183026900|SUPERIORITY||Difference|-0.701||||0.1962|TWO_SIDED|95.0|-1.7649|0.3627|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||0.3627|-1.7649|0.1962
91568879|NCT02484547|183026900|SUPERIORITY||Difference|-1.4||||0.0097|TWO_SIDED|95.0|-2.4596|-0.3396|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||-0.3396|-2.4596|0.0097
91568880|NCT02484547|183026901|SUPERIORITY||Difference|0.7||||0.1515|TWO_SIDED|95.0|-0.27|1.73|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.73|-0.27|0.1515
91568881|NCT02484547|183026901|SUPERIORITY||Difference|1.7||||0.0006|TWO_SIDED|95.0|0.75|2.74|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||2.74|0.75|0.0006
91568882|NCT03448536|183026920|SUPERIORITY||LS Means Difference|4.31|||<|0.001|TWO_SIDED|95.0|2.06|6.56|||ANCOVA|||||6.56|2.06|< 0.001
91568883|NCT03448536|183026921|SUPERIORITY||LS Means Difference|9.8|||<|0.001|TWO_SIDED|95.0|5.75|13.85|||ANCOVA|||||13.85|5.75|< 0.001
91568884|NCT03448536|183026922|SUPERIORITY||LS Means Difference|1.52|||=|0.129|TWO_SIDED|95.0|-0.45|3.49|||ANCOVA|||||3.49|-0.45|= 0.129
91568885|NCT03448536|183026923|SUPERIORITY||LS Means Difference|8.27|||<|0.001|TWO_SIDED|95.0|5.76|10.78|||ANCOVA|||||10.78|5.76|< 0.001
91568886|NCT03448536|183026924|SUPERIORITY||LS Means Difference|0.56|||=|0.307|TWO_SIDED|95.0|-0.52|1.64|||ANCOVA|||||1.64|-0.52|= 0.307
91568887|NCT03448536|183026925|SUPERIORITY||LS Means Difference|3.75|||<|0.001|TWO_SIDED|95.0|2.34|5.16|||ANCOVA|||||5.16|2.34|< 0.001
91568888|NCT03448536|183026926|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
91568889|NCT03448536|183026928|SUPERIORITY||||||=|0.002|||||||Cochran-Mantel-Haenszel|||||||= 0.002
91568890|NCT00988117|183026982|SUPERIORITY_OR_OTHER||Tscore|5.19|||<|0.01||95.0||||t-tests were statistically thresholded using the joint probability distribution method to correct for multiple comparisons, p \< 0.01 for voxel height and p \< 0.05 for cluster extent|t-test, 2 sided|A mask included only those regions where the patients showed abnormally low fALFF at either timepoint relative to a sample of 15 age-matched controls.||"Each voxel's BOLD signal time series was detrended and transformed to the frequency domain. We divided the sum of the square roots across the 0.01-0.08 Hz range by that across the entire frequency range (0-0.25 Hz).~fALFF group comparisons were evaluated using t-tests corrected for multiple comparisons. To determine if there were treatment-associated changes in brain activity, we compared voxel-wise fALFF in the patients at baseline to post-treatment."||||<0.01
91568891|NCT00988117|183026983|SUPERIORITY_OR_OTHER||pearson's r correlation coefficient|-0.82|||<|0.01||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left inferior frontal gyrus / premotor falff change||||<.01
91568892|NCT00988117|183026983|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|-0.35||||0.36||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.36
91568893|NCT00988117|183026984|SUPERIORITY_OR_OTHER||pearson's r correlation|0.18||||0.58||95.0|||||Regression, Linear|||correlation with left premotor / inferior frontal gyri falff change||||.58
91568894|NCT00988117|183026984|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|0.26||||0.41||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.41
91568895|NCT05400226|183026985|OTHER|Summary statistics of quantitative data, one-sided exact binomial test for null hypothesis, Clopper-Pearson method for 95% exact confidence intervals|Proportion|0.425|||<|0.0001|TWO_SIDED|95.0|0.27|0.591|||Exact Binomial Test||The Parameter Dispersion Value is the asymptotic standard error of the proportion.|Single arm open-label||0.591|0.270|< .0001
91568896|NCT05400226|183026986|OTHER||Proportion|0.85|||||TWO_SIDED|95.0|0.675|0.939||||||||0.939|0.675|
91568897|NCT05400226|183026987|OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.202|0.733||||||||0.733|0.202|
91568898|NCT05400226|183026988|OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.126|0.633||||||||0.633|0.126|
91568899|NCT05400226|183026989|OTHER||Proportion|0.773|||||TWO_SIDED|95.0|0.65|0.862||||||||0.862|0.650|
91568900|NCT01077622|183026991|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||SERC assessment|||93.3|34.8|
91568901|NCT01077622|183026991|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||Investigator assessment|||93.3|34.8|
91568902|NCT00424177|183027033|SUPERIORITY_OR_OTHER||Proportion of subjects in Cycle 2 or 3|0.87||||||95.0|0.74|0.94||||||||0.94|0.74|
91568903|NCT00562484|183027062|SUPERIORITY_OR_OTHER||Vaccine Efficacy|42.0|||||TWO_SIDED|95.0|30.0|52.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||52|30|
91568904|NCT00562484|183027063|SUPERIORITY_OR_OTHER||Vaccine efficacy|60.0|||||TWO_SIDED|95.0|44.0|72.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||72|44|
91568905|NCT02811302|183027081|OTHER|A simple count and percentage of the population were calculated based on the number of patients adjudicated as having Respiratory Depression.|||||||||||||||||To determine the risk assessment score, first the number of patients with Respiratory Depression (RD) had to be identified. Per the rules established for the Clinical Endpoint Committee, 655 (43.6%) patients were identified as having RD.|||
91568906|NCT02811302|183027082|OTHER|Multivariable model for (Multivariate logistic regression) Respiratory Depression, followed by validation with Harrell's Optimism using a bootstrap sampling method.|Area Under the Curve|0.76|||||TWO_SIDED|95.0|0.73|0.79|||||The model was performed using stepwise selection including all potential predictors and interactions terms (medical history and baseline characteristics).|A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.|The model derived from the logistic regression was assessed by the Hosmer-Lemshow goodness of fit test (P = 0.831). The derived model was validated by Harrell's Optimism using a Bootstrap sampling method (500 samples from the modified dataset, 1335) with replacement. The logistic regression model with stepwise selection was performed for each bootstrap sample, and AUC calculated. The optimism calculated by Harrell's algorithm was 0.02. The model was then checked for the quartiles of the effective monitoring and for geography used as a random effect. The performance measurement of the final model was adjusted according the Harrell's Optimism for a final adjusted AUC of 0.74.|0.79|0.73|
91568907|NCT02598934|183027088|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.002|TWO_SIDED|95.0|6.1|27.7||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate was effective in treating osteoporosis|Chi-squared, Corrected|||||27.7|6.1|0.002
91568908|NCT02598934|183027088|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.009|TWO_SIDED|95.0|4.0|25.8||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate reduces risk of breaking bone.|Chi-squared, Corrected|||||25.8|4.0|0.009
91568909|NCT02598934|183027088|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.001|TWO_SIDED|95.0|6.3|27.5|||Chi-squared, Corrected|P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis or reduces risk of breaking bone.||||27.5|6.3|0.001
91568910|NCT02598934|183027088|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.01|TWO_SIDED|95.0|3.9|25.9||P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis and reduces risk of breaking bone.|Chi-squared, Corrected|||||25.9|3.9|0.010
91568911|NCT02154347|183027094|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.95|-0.37|||t-test, 2 sided|||||-0.37|-0.95|<0.001
91568912|NCT02250183|183027123|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.|McNemar|McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.|2-sided|Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).||||1.00
91568913|NCT02250183|183027124|SUPERIORITY||Mean Difference (Final Values)|3.615|STANDARD_ERROR_OF_MEAN|0.79||0.003|TWO_SIDED|95.0|1.149|4.565||The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.|t-test, 2 sided|df = 13||A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.||4.565|1.149|.003
91568914|NCT03282799|183027126|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
91568915|NCT03282799|183027127|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
91568916|NCT03282799|183027128|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
91568917|NCT03282799|183027129|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
91568918|NCT03282799|183027130|OTHER|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
91568919|NCT03282799|183027131|OTHER|||||||0.784|||||||Wilcoxon (Mann-Whitney)|||||||.784
91568920|NCT03282799|183027132|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||||||.587
91568921|NCT03282799|183027133|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||.394
91568922|NCT03282799|183027134|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||.660
91568923|NCT03282799|183027135|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.290
91568924|NCT04702893|183027266|OTHER|No formal hypotheses were tested.||||||0.1185|||||||Z-test of correlation|||||||0.1185
91568925|NCT04702893|183027267|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Z-test of correlation|||||||0.5135
91568926|NCT04702893|183027268|OTHER|No formal hypotheses were tested.||||||0.0764|||||||Z-test of correlation|||||||0.0764
91568927|NCT04702893|183027269|OTHER|No formal hypotheses were tested.||||||0.3478|||||||Z-test of correlation|||||||0.3478
91568928|NCT01114139|183027276|SUPERIORITY|The 95% confidence interval was calculated using the large sample assumption.|Treatment Difference|75.59|||<|0.0001|TWO_SIDED|95.0|71.15|80.02|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - placebo) was expressed as a percentage.|Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.||80.02|71.15|<0.0001
91568929|NCT00477464|183027292|SUPERIORITY_OR_OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|44.2|72.4|||||The estimated value represents the percentage of participants who achieved a best overall response of complete response, partial response, or stable disease.|||72.4|44.2|
91568930|NCT03568812|183027312|SUPERIORITY||Mean Difference (Net)|111.8||||0.02|TWO_SIDED|95.0|40.9|182.7||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted CD4 level||182.7|40.9|0.02
91568931|NCT03568812|183027312|SUPERIORITY||Mean Difference (Net)|73.4||||0.03|TWO_SIDED|95.0|5.9|140.8||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted CD4 level||140.8|5.9|0.03
91568932|NCT03568812|183027313|SUPERIORITY||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.5|1.0||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of unadjusted Th17 change after intervention||1.0|-0.5|0.55
91568933|NCT03568812|183027313|SUPERIORITY||Mean Difference (Net)|0.1||||0.79|TWO_SIDED|95.0|-0.7|0.9||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of adjusted Th17 change after intervention||0.9|-0.7|0.79
91568934|NCT03568812|183027315|SUPERIORITY||Mean Difference (Net)|-12.7||||0.03|TWO_SIDED|95.0|-23.9|-1.5||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted Fecal Calprotectin Level change after intervention||-1.5|-23.9|0.03
91568935|NCT03568812|183027315|SUPERIORITY||Mean Difference (Net)|-15.6||||0.01|TWO_SIDED|95.0|-27.6|-3.6||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted Fecal Calprotectin Level change after intervention||-3.6|-27.6|0.01
91568936|NCT03568812|183027317|SUPERIORITY|||||||0.551||||||The threshold for statistical significance was p = 0.05|Chi-squared|||The statistical analysis of food frequency change after intervention (12 weeks)||||0.551
91568937|NCT00634842|183027325|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \< 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|1.86||||0.0411||95.0|1.03|3.37|||Test for Difference in Proportions|||To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.||3.37|1.03|0.0411
91568938|NCT00634842|183027326|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \<= 6.5% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|2.34||||0.0064||95.0|1.27|4.3|||Regression, Logistic|||||4.30|1.27|0.0064
91568939|NCT00634842|183027327|SUPERIORITY_OR_OTHER||LSMean|-0.271||||0.0019||95.0|-0.441|-0.101|||ANCOVA|The analyses for HbA1c were adjusted for baseline HbA1c values.||||-0.101|-0.441|0.0019
91568940|NCT03954223|183027346|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||ANOVA|||||||0.4
91568941|NCT03954223|183027347|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.2|TWO_SIDED|95.0|||||Regression, Linear|Mixed-effects generalized linear model of the glycemic profile change extracted from CGM data.||||||0.2
91568942|NCT01086384|183027382|SUPERIORITY_OR_OTHER||Regression Cox|0.795|||||TWO_SIDED|95.0|0.642|0.985|||||The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|||0.985|0.642|
91568943|NCT01086384|183027382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|15.9||||0.036|TWO_SIDED|95.0|13.5|18.2||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||18.2|13.5|0.036
91568944|NCT01086384|183027382|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.8||||0.036|TWO_SIDED|95.0|10.7|14.9||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||14.9|10.7|0.036
91568945|NCT02586415|183027385|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.63|4.7||Criteria to assess superiority was a two-sided P value of \<0.05. The study was terminated early because the pre-specified stopping boundary of P \<0.0025 was crossed at the first interim analysis (N=182)|Cochran-Mantel-Haenszel|||||4.70|1.63|<0.001
91568946|NCT00832000|183027393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_DEVIATION|1.24|<|0.001|TWO_SIDED|95.0|-2.66|-0.706|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.706|-2.66|<0.001
91568947|NCT00832000|183027393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_DEVIATION|1.24||0.04||95.0|-3.85|-0.139|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.139|-3.85|0.04
91568948|NCT00832000|183027394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_DEVIATION|1.19|<|0.001|TWO_SIDED|95.0|-2.0|-1.26|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.26|-2.00|<0.001
91568949|NCT00832000|183027395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_DEVIATION|1.27|<|0.001|TWO_SIDED|95.0|-1.67|-0.861|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.861|-1.67|<0.001
91568950|NCT00832000|183027396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.918|STANDARD_DEVIATION|1.29|<|0.001|TWO_SIDED|95.0|-1.3|-0.532|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.532|-1.30|<0.001
91568951|NCT00832000|183027397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.109|STANDARD_DEVIATION|0.563|<|0.001|TWO_SIDED|95.0|-0.177|-0.056|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.056|-0.177|<0.001
91568952|NCT00832000|183027398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_DEVIATION|13.1||0.09|TWO_SIDED|95.0|-0.68|9.75|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||9.75|-0.680|0.09
91568953|NCT00832000|183027399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.568|STANDARD_DEVIATION|0.6|<|0.001|TWO_SIDED|95.0|-0.812|-0.325|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.325|-0.812|<0.001
91568954|NCT00832000|183027400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|1.083|<|0.001|TWO_SIDED|95.0|-0.633|-0.142|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.142|-0.633|<0.001
91568955|NCT00832000|183027401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_DEVIATION|0.889|<|0.001|TWO_SIDED|95.0|-0.602|-0.149|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.149|-0.602|<0.001
91568956|NCT00832000|183027402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_DEVIATION|0.516|<|0.001|TWO_SIDED|95.0|-0.675|-0.254|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.254|-0.675|<0.001
91568957|NCT00832000|183027403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|12.6||0.5|TWO_SIDED|95.0|-3.34|6.73|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||6.73|-3.34|0.50
91568958|NCT00832000|183027404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_DEVIATION|3.44|<|0.001|TWO_SIDED|95.0|-4.07|-1.3|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.30|-4.07|<0.001
91568959|NCT00832000|183027405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.58|STANDARD_DEVIATION|5.35|<|0.001|TWO_SIDED|95.0|3.44|7.72|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||7.72|3.44|<0.001
91568960|NCT00832000|183027406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_DEVIATION|6.5||0.9|TWO_SIDED|95.0|-5.87|5.17|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||5.17|-5.87|0.90
91568961|NCT00832000|183027406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|6.5||0.03|TWO_SIDED|95.0|0.941|20.6|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||20.6|0.941|0.03
91568962|NCT03974100|183027407|EQUIVALENCE|Equivalence criteria (analysis set PPS): 95% CI for difference in means contained in \[-1.45%, 1.45%\]|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.3325|||TWO_SIDED|95.0|-0.798|0.509|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.509|-0.798|
91568963|NCT03974100|183027408|EQUIVALENCE|Equivalence criteria (analysis set TP1 FAS): 95% CI for difference in means contained in \[-1.45%, 1.45%\] (criteria 1) or in \[-2.00%, 2.00%\] (criteria 2)|Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.3321|||TWO_SIDED|95.0|-0.83|0.475|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.475|-0.830|
91568964|NCT03974100|183027409|EQUIVALENCE|Equivalence criteria (analysis set PDS): 95% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
91568965|NCT03974100|183027409|EQUIVALENCE|Equivalence criteria (analysis set PDS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
91568966|NCT03974100|183027410|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.92|1.03|||ANCOVA|ANCOVA was performed on log-transformed Cmax including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.03|0.92|
91568967|NCT03974100|183027411|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05|||ANCOVA|ANCOVA was performed on log-transformed AUCinf including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.05|0.93|
91568968|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.58|-1.4|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-1.40|-4.58|0.0002
91568969|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-3.78|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.38|-2.17|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-2.17|-5.38|<.0001
91568970|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-6.07|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-7.77|-4.36|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.36|-7.77|<.0001
91568971|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-6.68|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.28|-5.09|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-5.09|-8.28|<.0001
91568972|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-7.79|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-9.42|-6.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-6.16|-9.42|<.0001
91568973|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-5.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-7.61|-4.35|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.35|-7.61|<.0001
91568974|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|2.99|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|1.38|4.6|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||4.60|1.38|0.0003
91568975|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|2.2|STANDARD_ERROR_OF_MEAN|0.83||0.0082|TWO_SIDED|95.0|0.57|3.84|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||3.84|0.57|0.0082
91568976|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-0.09|STANDARD_ERROR_OF_MEAN|0.88||0.9209|TWO_SIDED|95.0|-1.82|1.64|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||1.64|-1.82|0.9209
91568977|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-0.7|STANDARD_ERROR_OF_MEAN|0.83||0.396|TWO_SIDED|95.0|-2.33|0.92|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||0.92|-2.33|0.3960
91568978|NCT03856047|183027447|SUPERIORITY||Treatment difference (%-points)|-1.81|STANDARD_ERROR_OF_MEAN|0.84||0.0316|TWO_SIDED|95.0|-3.46|-0.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-0.16|-3.46|0.0316
91568979|NCT00338949|183027474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.228|||||||t-test, 2 sided|||||||0.228
91568980|NCT00338949|183027475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|||||||t-test, 2 sided|||||||0.958
91568981|NCT02271230|183027512|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.78|1.11||||||||1.11|0.78|
91568982|NCT02271230|183027512|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.8|1.14||||||||1.14|0.80|
91568983|NCT02271230|183027513|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
91568984|NCT02271230|183027513|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|0.998||||||||0.998|0.74|
91568985|NCT02601209|183027545|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED|||||||||||||
91568986|NCT02601209|183027546|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1419|ONE_SIDED|85.0||1.7|||Log Rank|1-sided statistical test and p-value||||1.70||0.1419
91568987|NCT02024750|183027561|OTHER||Mean Difference (Net)|0.005||||0.72|TWO_SIDED|95.0|-0.021|0.03||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.030|-0.021|0.72
91568988|NCT02024750|183027561|OTHER||Mean Difference (Net)|-0.01||||0.38|TWO_SIDED|95.0|-0.034|0.013||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.013|-0.034|0.38
91568989|NCT02024750|183027562|OTHER||Mean Difference (Net)|0.023||||0.87|TWO_SIDED|95.0|-0.249|0.295||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.295|-0.249|0.87
91568990|NCT02024750|183027562|OTHER||Mean Difference (Net)|-0.074||||0.74|TWO_SIDED|95.0|-0.517|0.369||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.369|-0.517|0.74
91568991|NCT02024750|183027563|OTHER||Mean Difference (Net)|-0.037||||0.79|TWO_SIDED|95.0|-0.312|0.237||The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.237|-0.312|0.79
91568992|NCT02024750|183027563|OTHER||Mean Difference (Net)|-0.009||||0.97|TWO_SIDED|95.0|-0.467|0.448||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.448|-0.467|0.97
91568993|NCT02024750|183027564|OTHER||Mean Difference (Net)|0.134||||0.3|TWO_SIDED|95.0|-0.121|0.388||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.388|-0.121|0.30
91568994|NCT02024750|183027564|OTHER||Mean Difference (Net)|-0.006||||0.98|TWO_SIDED|95.0|-0.384|0.373||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.373|-0.384|0.98
91568995|NCT03029819|183027611|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||.52
91568996|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.13||0.23|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.23
91568997|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.07
91568998|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.99|TWO_SIDED||||||Regression, Linear|||Orienting. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.99
91568999|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED||||||Regression, Linear|||Fidget. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.005
91569000|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.01
91569001|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.04|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.04
91569002|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.06|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.06
91569003|NCT03605368|183027619|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.14||0.09|TWO_SIDED||||||Regression, Linear|||||||.09
91569004|NCT03605368|183027620|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|2.67||0.55|TWO_SIDED||||||Regression, Linear|||||||.55
91569005|NCT03605368|183027620|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|2.73||0.05|TWO_SIDED||||||Regression, Linear|||||||.05
91569006|NCT01149876|183027622|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
91569007|NCT01149876|183027622|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
91569008|NCT01149876|183027622|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||.48
91569009|NCT01817712|183027657|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.46|3.14|||Regression, Logistic|||||3.14|1.46|<0.001
91569010|NCT01817712|183027658|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|Site used as strata||||||0.004
91569011|NCT01817712|183027659|OTHER|Longitudinal analysis of PCL-5 (change from baseline)|Mean Difference (Net)|-1.9||||0.07|TWO_SIDED|95.0|-3.91|0.12|||Mixed Models Analysis|||||0.12|-3.91|0.07
91569012|NCT03302559|183027734|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||<0.001
91569013|NCT03302559|183027735|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.005||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.005
91569014|NCT03302559|183027735|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.02
91569015|NCT03302559|183027735|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||0.0006
91569016|NCT03302559|183027735|OTHER|Testing hypothesis is that the mean change from baseline is zero||||||0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.001
91569017|NCT03302559|183027736|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.02
91569018|NCT03302559|183027736|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.006
91569019|NCT03302559|183027736|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||<0.001
91569020|NCT03302559|183027736|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.5||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.5
91569021|NCT03302559|183027737|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.002||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.002
91569022|NCT03302559|183027738|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0008||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.0008
91569023|NCT03302559|183027739|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.02
91569024|NCT03302559|183027744|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.3||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Normal Skin)||||0.3
91569025|NCT03302559|183027744|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.4||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Target Lesion)||||0.4
91569026|NCT02080403|183027751|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.1159|TWO_SIDED|95.0|-0.4|0.04|||Mixed Models Analysis|||||0.04|-0.40|0.1159
91569027|NCT01171183|183027779|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.52|STANDARD_DEVIATION|37.64||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91569028|NCT01171183|183027780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_DEVIATION|4.54||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
91569029|NCT04260464|183027781|OTHER||Test/Reference Ratio|110.15|||||TWO_SIDED|95.0|83.76|144.86||||||Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||144.86|83.76|
91569030|NCT04260464|183027781|OTHER||Test/Reference Ratio|94.58|||||TWO_SIDED|90.0|55.84|160.19||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||160.19|55.84|
91569031|NCT04260464|183027781|OTHER||Test/Reference Ratio|124.2|||||TWO_SIDED|90.0|100.24|153.89||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||153.89|100.24|
91569032|NCT04260464|183027782|OTHER||Test/Reference Ratio|112.08|||||TWO_SIDED|95.0|60.85|206.45||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||206.45|60.85|
91569033|NCT04260464|183027782|OTHER||Test/Reference Ratio|70.97|||||TWO_SIDED|90.0|27.6|182.49||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||182.49|27.60|
91569034|NCT04260464|183027782|OTHER||Test/Reference Ratio|147.7|||||TWO_SIDED|90.0|75.17|290.21||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||290.21|75.17|
91569035|NCT04260464|183027783|OTHER||Test/Reference Ratio|177.53|||||TWO_SIDED|95.0|135.82|232.04||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||232.04|135.82|
91569036|NCT04260464|183027783|OTHER||Test/Reference Ratio|132.69|||||TWO_SIDED|90.0|95.08|185.17||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.17|95.08|
91569037|NCT04260464|183027783|OTHER||Test/Reference Ratio|122.04|||||TWO_SIDED|90.0|84.47|176.3||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||176.30|84.47|
91569038|NCT04260464|183027784|OTHER||Test/Reference Ratio|445.99|||||TWO_SIDED|95.0|326.55|609.13||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||609.13|326.55|
91569039|NCT04260464|183027784|OTHER||Test/Reference Ratio|144.63|||||TWO_SIDED|90.0|112.76|185.5||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.50|112.76|
91569040|NCT04260464|183027784|OTHER||Test/Reference Ratio|229.12|||||TWO_SIDED|90.0|189.97|276.35||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||276.35|189.97|
91569041|NCT02806505|183027798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.6746|TWO_SIDED|95.0|0.49|3.06||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.06|0.49|0.6746
91569042|NCT02806505|183027799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3923|TWO_SIDED|95.0|0.6|3.76||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.76|0.60|0.3923
91569043|NCT02806505|183027800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8843|TWO_SIDED|95.0|0.43|2.68||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 12: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.68|0.43|0.8843
91569044|NCT02806505|183027800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5866|TWO_SIDED|95.0|0.28|2.04||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 24: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.04|0.28|0.5866
91569045|NCT03898700|183027815|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
91569046|NCT03898700|183027815|OTHER||Median Difference (Net)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
91569047|NCT00511836|183027842|SUPERIORITY_OR_OTHER||||||<|2e-05|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0.||||<0.00002
91569048|NCT00511836|183027845|SUPERIORITY_OR_OTHER||||||<|0.013|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||<0.013
91569049|NCT00511836|183027846|SUPERIORITY_OR_OTHER|||||||0.245|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||0.245
91569050|NCT00362375|183027883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.05|TWO_SIDED|95.0|1.28|4.5|||Generalized Estimating Equation|||GEE cluster-adjusted odds ratio||4.50|1.28|<0.05
91569051|NCT00362375|183027884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||<|0.05|TWO_SIDED|95.0|0.2|1.16|||GEE|||||1.16|0.20|<0.05
91569052|NCT00362375|183027885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39|||<|0.05|TWO_SIDED|95.0|0.99|1.95|||GEE|||||1.95|0.99|<0.05
91569053|NCT00362375|183027886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|||<|0.05|TWO_SIDED|95.0|0.8|1.44|||GEE|GEE incident rate ratio||||1.44|0.80|<0.05
91569054|NCT00362375|183027887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||<|0.05|TWO_SIDED|95.0|0.76|2.71|||GEE|||||2.71|0.76|<0.05
91569055|NCT02106195|183027892|SUPERIORITY|Change from Baseline to Day 28|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|3.04||0.324|TWO_SIDED|95.0|-3.7|1.4|||t-test, 2 sided|||||1.4|-3.7|0.324
91569056|NCT01101997|183027944|SUPERIORITY||sucess proportion|0.853|||<|0.001|TWO_SIDED|95.0|0.773|0.91|||Chi-squared|||H0: p= 0.6 and Ha: p ≠ 0.6||.910|.773|<0.001
91569057|NCT01101997|183027945|OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|2.49|||TWO_SIDED|||||||||||||
91569058|NCT00469456|183027966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.07||95.0|-0.1|2.8|||ANCOVA|||The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||2.8|-0.1|0.070
91569059|NCT00469456|183027967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.022||95.0|0.9|10.9|||ANCOVA|||The secondary efficacy parameter was change from Baseline at Week 12 in the total score of the Social Communication subscale and Communication of Basic Needs subscale of the ASHA FACS. Missing scores at week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||10.9|0.9|0.022
91569060|NCT00704171|183027983|SUPERIORITY_OR_OTHER|||||||0.257|||||||Fisher Exact|||Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).||||0.257
91569061|NCT00704171|183027984|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|two-sided||||||<0.001
91569062|NCT00704171|183027985|SUPERIORITY_OR_OTHER|||||||0.79|||||||Kaplan-Meier|Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.||||||0.790
91569063|NCT00704171|183027986|SUPERIORITY_OR_OTHER|||||||0.559|||||||2-sample t-test|||||||0.559
91569064|NCT00704171|183027987|SUPERIORITY_OR_OTHER|||||||0.292|||||||2-sample t-test|||||||0.292
91569065|NCT00704171|183027988|SUPERIORITY_OR_OTHER|||||||0.53||||||For subgroup with pre-randomization air leak grade of 1|Fisher Exact|||||||0.53
91569066|NCT00704171|183027988|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||For subgroup with pre-randomization air leak grade of 2 or 3|Fisher Exact|||||||.013
91569067|NCT00913068|183027989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Chi-squared|||||||0.0012
91569068|NCT04269434|183027996|NON_INFERIORITY|"The No Screening Arm is considered non-inferior if the upper limit of the 95% Confidence Interval is less than 1.25"|Incidence rate ratio|1.318|||||TWO_SIDED|95.0|1.068|1.627||||||Compared to screening group||1.627|1.068|
91569069|NCT04269434|183027997|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.788|||||TWO_SIDED|95.0|0.719|0.863||||||For Azithromycin. Compared to screening group||0.863|0.719|
91569070|NCT04269434|183027997|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.561|||||TWO_SIDED|95.0|0.426|0.739||||||For Ceftriaxone. Compared to screening group||0.739|0.426|
91569071|NCT04269434|183027997|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.515|0.588||||||For Doxycycline. Compared to screening group||0.588|0.515|
91569072|NCT04269434|183027998|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.373|||||TWO_SIDED|95.0|0.963|1.956||||||Compared to screening group||1.956|0.963|
91569073|NCT04269434|183027999|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.471|||||TWO_SIDED|95.0|0.943|2.299||||||Compared to screening group||2.299|0.943|
91569074|NCT01772563|183028000|OTHER||Geometric mean ratio (GMR) [%]|93.63|||||TWO_SIDED|90.0|82.07|106.81|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=25.1.|"Statistical analysis of Volasertib:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||106.81|82.07|
91569075|NCT01772563|183028000|OTHER||Geometric mean ratio (GMR) [%]|75.77|||||TWO_SIDED|90.0|67.83|84.632|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=21.0.|"Statistical analysis of CD 10899:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||84.632|67.830|
91569076|NCT01772563|183028001|OTHER||Geometric mean ratio (GMR) [%]|79.4|||||TWO_SIDED|90.0|64.896|97.137|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=39.3.|"Statistical analysis of volasertib:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||97.137|64.896|
91569077|NCT01772563|183028001|OTHER||Geometric mean ratio (GMR) [%]|63.48|||||TWO_SIDED|90.0|55.372|72.775|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=26.1.|"Statistical analysis of CD 10899:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||72.775|55.372|
91569078|NCT01772563|183028002|OTHER||Geometric mean ratio (GMR) [%]|97.85|||||TWO_SIDED|90.0|87.09|109.94|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.7.|"Statistical analysis of volasertib:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||109.94|87.09|
91569079|NCT01772563|183028002|OTHER||Geometric mean ratio (GMR) [%]|77.42|||||TWO_SIDED|90.0|69.001|86.871|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.5.|"Statistical analysis of CD 10899:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||86.871|69.001|
91569080|NCT01196819|183028004|NON_INFERIORITY|Non-inferiority margin is 0.13mm, if the two-sided upper 95% confidence bound is \<Δ, the Firehawk Stent being tested will be considered non-inferior to the control. This corresponds to a P value \<0.05 from a two-sided Student t-test comparing the difference between FirehawkStent and Xience stent to delta.|Mean Difference (Final Values)|0.17||||0.94|TWO_SIDED|95.0|0.0|0.29|||ANCOVA|||H0: Pe - Pc≥ ∆, H1: Pe - Pc \< ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .||0.29|0|0.94
91569081|NCT01196819|183028005|NON_INFERIORITY|Assume the in-stent percent diameter stenosis of both FIREHAWK and XIENCE V are 16 ± 16%, the non-inferiority value is 5%, the level of statistical significance is 0.05 (bilateral test), the power is 85%.||||||0.69|||||||Mixed Models Analysis|||||||0.69
91569082|NCT01196819|183028006|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91569083|NCT01196819|183028007|OTHER|||||||0.76|||||||Fisher Exact|||||||0.76
91569084|NCT01196819|183028008|OTHER|||||||0.77|||||||Fisher Exact|||||||0.77
91569085|NCT01196819|183028009|OTHER|||||||1|||||||Fisher Exact|||||||1.0
91569086|NCT01438840|183028061|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91569087|NCT02604342|183028064|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Stratified log-rank test||Estimated hazard ratio obtained from stratified Cox model with treatment group as covariate.|||0.33|0.12|<0.001
91569088|NCT02604342|183028065|SUPERIORITY||Difference in C-ORR|0.667|||<|0.001|TWO_SIDED|95.0|0.39|0.86|||Chi-squared|||95% confidence interval of the difference (alectinib - chemotherapy) computed using Hauck-Anderson approach.||0.86|0.39|<0.001
91569089|NCT01702519|183028088|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25|Treatment Ratio|0.946|||||TWO_SIDED|90.0|0.912|0.982|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the two treatments.||0.982|0.912|
91569090|NCT01702519|183028089|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25.|Treatment Ratio|0.962|||||TWO_SIDED|90.0|0.92|1.0|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the treatments.||1.00|0.92|
91569091|NCT02920021|183028114|SUPERIORITY||Least Squares (LS) Mean Difference|60.046|STANDARD_ERROR_OF_MEAN|79.918||0.463|TWO_SIDED|95.0|-108.566|228.657|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||228.657|-108.566|0.463
91569092|NCT02920021|183028115|SUPERIORITY||LS Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.016||0.962|TWO_SIDED|95.0|-0.031|0.032|||ANCOVA|ANCOVA model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||0.032|-0.031|0.962
91569093|NCT02166476|183028161|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Noninferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference for overall success at EOIVT was \>-15%.|Treatment difference|4.5|||||TWO_SIDED|95.0|0.7|9.1|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||9.1|0.7|
91569094|NCT02166476|183028162|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the m-MITT Population.|Treatment difference|9.0|||||TWO_SIDED|95.0|-0.9|18.7|||||Treatment difference is the estimate of the difference in the Eradication rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||18.7|-0.9|
91569095|NCT02166476|183028163|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the ME Population.|Treatment Difference|5.9|||||TWO_SIDED|95.0|-4.2|16.0|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the ME population||16.0|-4.2|
91569096|NCT04469465|183028207|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Interim Efficacy Analysis||||0.0007
91569097|NCT04469465|183028207|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Full Analysis||||0.0007
91569098|NCT04469465|183028207|SUPERIORITY||LS Mean Difference|24.44|STANDARD_ERROR_OF_MEAN|3.751|<|0.0001|TWO_SIDED|95.0|16.9|31.99|||Mixed Models Analysis|||Interim Efficacy Analysis||31.99|16.90|<0.0001
91569099|NCT04469465|183028207|SUPERIORITY||Difference|23.46|STANDARD_ERROR_OF_MEAN|3.585|<|0.0001|TWO_SIDED|95.0|16.31|30.61|||Mixed Models Analysis|||Full Analysis||30.61|16.31|<0.0001
91569100|NCT01642147|183028254|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||0.554
91569101|NCT01642147|183028255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
91569102|NCT01642147|183028256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
91569103|NCT01642147|183028257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
91569104|NCT01642147|183028258|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
91569105|NCT01642147|183028259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
91569106|NCT01844726|183028292|SUPERIORITY||Mean Difference (Net)|0.05||||0.1|TWO_SIDED||||||t-test, 2 sided|||Change in BOLD signal activation across task derived learning circuit were compared between GLYX-13 and placebo groups using an independent group t-test.||||.10
91569107|NCT01844726|183028293|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||.57
91569108|NCT02229578|183028294|SUPERIORITY||Mean Difference (Final Values)|0.45|||<|0.05|TWO_SIDED|95.0|-1.2|2.1|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||2.1|-1.2|<0.05
91569109|NCT02229578|183028295|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.79|<|0.05|TWO_SIDED|95.0|-1.77|1.49|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||1.49|-1.77|<0.05
91569110|NCT02229578|183028296|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|3.61|<|0.05|TWO_SIDED|95.0|-9.62|6.09|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop hydromorphone on 24 hour hydromorphone. This allows patient to serve as own control for intial values.||6.09|-9.62|<0.05
91569111|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.05||||0.8916|TWO_SIDED|95.0|-0.81|0.7|||ANCOVA|||||0.70|-0.81|0.8916
91569112|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.22||||0.5569|TWO_SIDED|95.0|-0.95|0.51|||ANCOVA|||||0.51|-0.95|0.5569
91569113|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.53||||0.1544|TWO_SIDED|95.0|-1.25|0.2|||ANCOVA|||||0.20|-1.25|0.1544
91569114|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.94||||0.0137|TWO_SIDED|95.0|-1.69|-0.19|||ANCOVA|||||-0.19|-1.69|0.0137
91569115|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.88||||0.0171|TWO_SIDED|95.0|-1.61|0.16|||ANCOVA|||||0.16|-1.61|0.0171
91569116|NCT01496365|183028308|SUPERIORITY||Least square means|-1.01||||0.006|TWO_SIDED|95.0|-1.74|-0.29|||ANCOVA|||||-0.29|-1.74|0.0060
91569117|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.17||||0.7051|TWO_SIDED|95.0|-1.03|0.69|||ANCOVA|||||0.69|-1.03|0.7051
91569118|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.47||||0.2772|TWO_SIDED|95.0|-1.33|0.38|||ANCOVA|||||0.38|-1.33|0.2772
91569119|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.89||||0.0458|TWO_SIDED|95.0|-1.77|-0.02|||ANCOVA|||||-0.02|-1.77|0.0458
91569120|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.83||||0.0569|TWO_SIDED|95.0|-1.69|0.02|||ANCOVA|||||0.02|-1.69|0.0569
91569121|NCT01496365|183028308|SUPERIORITY||Least squares mean|-0.96||||0.0271|TWO_SIDED|95.0|-1.81|-0.11|||ANCOVA|||||-0.11|-1.81|0.0271
91569122|NCT01015677|183028321|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.28||||0.488|TWO_SIDED|95.0|-24.2|11.64|||Longitudinal Data Analysis (LDA)|LDA model terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||11.64|-24.20|0.488
91569123|NCT01015677|183028321|SUPERIORITY_OR_OTHER||Difference in the least squares means|-17.45||||0.069|TWO_SIDED|95.0|-36.28|1.38|||Longitudinal Data Analysis|LDA model with terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||1.38|-36.28|0.069
91569124|NCT01015677|183028324|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.05||||0.529|TWO_SIDED|95.0|-25.06|12.96|||Longitudinal Data Analysis (LDA)|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||12.96|-25.06|0.529
91569125|NCT01015677|183028324|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.22||||0.264|TWO_SIDED|95.0|-31.03|8.59|||Longitudinal Data Analysis|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||8.59|-31.03|0.264
91569126|NCT01015677|183028325|SUPERIORITY_OR_OTHER||Difference in LS means|0.94||||0.827|TWO_SIDED|90.0|-6.19|8.07|||ANCOVA|Analysis of covariance (ANCOVA) with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||8.07|-6.19|0.827
91569127|NCT01015677|183028325|SUPERIORITY_OR_OTHER||Difference in the LS means|-14.52||||0.001|TWO_SIDED|90.0|-21.73|-7.32|||ANCOVA|ANCOVA with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||-7.32|-21.73|0.001
91569128|NCT01660256|183028326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91569129|NCT01660256|183028327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91569130|NCT01646385|183028331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.084|TWO_SIDED|95.0|0.683|1.025|||Regression, Cox|||Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis.||1.025|0.683|0.084
91569131|NCT01646385|183028332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.512||||0.035|TWO_SIDED|95.0|0.276|0.952|||Regression, Cox|||Cox proportional hazards model adjusted for age was used for analysis.||0.952|0.276|0.035
91569132|NCT01646385|183028333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.019||||0.855|TWO_SIDED|95.0|0.831|1.251|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, baseline DMARDs, methotrexate, disease activity score based on 28-joints count (DAS28), and smoking history was used for analysis.||1.251|0.831|0.855
91569133|NCT01646385|183028334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.564|0.87|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, and baseline health assessment questionnaire (HAQ) score was used for analysis.||0.870|0.564|0.001
91569134|NCT01646385|183028335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717||||0.024|TWO_SIDED|95.0|0.537|0.958|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, baseline HAQ score, Charlson index, smoking history, and body mass index was used for analysis.||0.958|0.537|0.024
91569135|NCT01646385|183028338|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91569136|NCT01646385|183028339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with Analysis of Covariance (ANCOVA) using the General Linear Model (GLM) method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
91569137|NCT01646385|183028339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
91569138|NCT01646385|183028339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
91569139|NCT01646385|183028339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 4: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
91569140|NCT01646385|183028339|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Change at Year 5: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||0.01
91569141|NCT01646385|183028342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91569142|NCT01646385|183028343|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
91569143|NCT01646385|183028343|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
91569144|NCT01646385|183028343|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
91569145|NCT03603639|183028358|SUPERIORITY||LS Mean difference|1.38|||||TWO_SIDED|90.0|-0.72|3.48||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.48|-0.72|
91569146|NCT03603639|183028358|SUPERIORITY||LS Mean difference|1.07|||||TWO_SIDED|90.0|-0.49|2.63||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.63|-0.49|
91569147|NCT03603639|183028359|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|90.0|-0.75|1.54||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.54|-0.75|
91569148|NCT03603639|183028359|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|90.0|-0.6|1.21||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.21|-0.60|
91569149|NCT03603639|183028359|SUPERIORITY||LS Mean Difference|1.62|||||TWO_SIDED|90.0|-1.16|4.39||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||4.39|-1.16|
91569150|NCT03603639|183028359|SUPERIORITY||LS Mean Difference|1.05|||||TWO_SIDED|90.0|-0.89|2.98||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.98|-0.89|
91569151|NCT03603639|183028359|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|90.0|-1.87|2.28||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.28|-1.87|
91569152|NCT03603639|183028359|SUPERIORITY||LS Mean Difference|1.27|||||TWO_SIDED|90.0|-0.57|3.11||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.11|-0.57|
91569153|NCT00858247|183028382|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
91569154|NCT00858247|183028383|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||||||0.80
91569155|NCT00858247|183028384|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANCOVA|||||||0.65
91569156|NCT00858247|183028385|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||||||0.68
91569157|NCT00858247|183028386|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANCOVA|||||||0.40
91569158|NCT00858247|183028387|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANCOVA|||||||0.47
91569159|NCT02165397|183028400|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.148|0.42||The treatment effect was tested with a stratified log rank test.|Log Rank||The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.|||0.420|0.148|< 0.0001
91569160|NCT02165397|183028401|SUPERIORITY||Rate Ratio|2.526|||<|0.0001|TWO_SIDED|95.0|1.753|3.639||Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.|Cochran-Mantel-Haenszel|||||3.639|1.753|< 0.0001
91569161|NCT02165397|183028402|SUPERIORITY||Hazard Ratio (HR)|0.102|||<|0.0001|TWO_SIDED|95.0|0.049|0.212||P-value is from a stratified log-rank test.|Log Rank||Hazard ratio is estimated using a stratified Cox regression model.|||0.212|0.049|< 0.0001
91569162|NCT02165397|183028403|SUPERIORITY||Rate Ratio|1.813|||<|0.0001|TWO_SIDED|95.0|1.357|2.421|||Chi-squared|||||2.421|1.357|< 0.0001
91569163|NCT02165397|183028404|SUPERIORITY||Rate Ratio|1.238||||0.1059|TWO_SIDED|95.0|0.955|1.603||CMH chi squared test|Cochran-Mantel-Haenszel|||||1.603|0.955|0.1059
91569164|NCT02165397|183028405|SUPERIORITY||Hazard Ratio (HR)|0.808||||0.643|TWO_SIDED|95.0|0.328|1.99||P-value is from unstratified log rank test.|Log Rank||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|Data cutoff 18 December 2019||1.99|0.328|0.643
91569165|NCT03463577|183028416|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.38|||||TWO_SIDED|98.75|1.21|1.58|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted relative risk (RR) for pre-eclampsia and eclampsia in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.58|1.21|
91569166|NCT03463577|183028416|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.28|||||TWO_SIDED|98.75|1.12|1.47|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for intra-uterine infections (chorioamnionitis and endometritis) in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.47|1.12|
91569167|NCT03463577|183028417|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|0.71|||||TWO_SIDED|98.75|0.64|0.78|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for preterm delivery in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||0.78|0.64|
91569168|NCT03463577|183028418|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.04|||||TWO_SIDED|98.75|0.94|1.16|||||Adjusted RR with 98.75% CI-Poisson regression model|Demonstration of adjusted RR for small for gestational age in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was less than 2 (non-inferiority testing).||1.16|0.94|
91569169|NCT03463577|183028419|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.7|0.98|||||Adjusted RR with 95% CI -Poisson regression model|Assessment of adjusted RR for poor fetal growth in the Exposed pregnant women cohort (on or after 1st day of 27th week of pregnancy) compared to the Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.98|0.70|
91569170|NCT03463577|183028419|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.99|1.72|||||Adjusted RR with 95% CI - Poisson regression model|Assessment of adjusted RR for placental abortion in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.72|0.99|
91569171|NCT03463577|183028419|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.64|0.91|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for preterm pre-labor rupture of membranes in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.91|0.64|
91569172|NCT03463577|183028420|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR =1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.38|||||TWO_SIDED|95.0|0.22|0.67|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for stillbirth/fetal death in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.67|0.22|
91569173|NCT03463577|183028420|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for transfusion during delivery hospitalization in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.33|0.86|
91569174|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.38|1.73|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for neonatal death in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.73|0.38|
91569175|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.81|2.24|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of nervous system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.24|0.81|
91569176|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.06|1.29|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of eye in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.29|1.06|
91569177|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|2.02|||||TWO_SIDED|95.0|1.59|2.55|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of ear, face or neck in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||2.55|1.59|
91569178|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.96|1.31|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of cardiovascular system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infant cohort was 1 or differed from 1 (superiority testing).||1.31|0.96|
91569179|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.34|||||TWO_SIDED|95.0|1.07|1.68|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of respiratory system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was1 or differed from 1 (superiority testing).||1.68|1.07|
91569180|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.41||||||95.0|0.78|2.57|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for clefts in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.57|0.78|
91569181|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.75|||||TWO_SIDED|95.0|1.57|1.95|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of upper gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.95|1.57|
91569182|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of lower gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.12|0.36|
91569183|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|1.01|1.42|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of genital organs in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.42|1.01|
91569184|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|1.04|1.88|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of renal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||1.88|1.04|
91569185|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.5||||||95.0|1.21|1.86|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of musculoskeletal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.86|1.21|
91569186|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of limb in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.52|0.85|
91569187|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.98|||||TWO_SIDED|95.0|1.76|2.23|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of integument in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.23|1.76|
91569188|NCT03463577|183028421|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.64|1.85|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for other and unspecified congenital anomalies in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.85|0.64|
91569189|NCT00236184|183028429|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||<0.001
91569190|NCT01841697|183028430|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.|Difference in least squares mean|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||Difference is omarigliptin minus sitagliptin.|Constrained longitudinal data analysis||0.08|-0.15|
91569191|NCT01841697|183028431|SUPERIORITY_OR_OTHER||Difference in percent|-4.3|||||TWO_SIDED|95.0|-11.8|3.2|||||Difference is omarigliptin minus sitagliptin.|||3.2|-11.8|
91569192|NCT01841697|183028432|SUPERIORITY_OR_OTHER||Difference in percent|-1.3|||||TWO_SIDED|95.0|-3.6|0.8|||||Difference is omarigliptin minus sitagliptin.|||0.8|-3.6|
91569193|NCT01841697|183028433|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.2||||0.089|TWO_SIDED|95.0|-9.0|0.6|||Constrained logitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|Difference is omarigliptin minus sitagliptin.|||0.6|-9.0|0.089
91569194|NCT01841697|183028434|SUPERIORITY_OR_OTHER||Between-group rate difference|2.0||||0.619|TWO_SIDED|95.0|-5.9|9.9|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||9.9|-5.9|0.619
91569195|NCT01841697|183028435|SUPERIORITY_OR_OTHER||Between-group rate difference|4.4||||0.212|TWO_SIDED|95.0|-2.5|11.4|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||11.4|-2.5|0.212
91569196|NCT01898442|183028443|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANCOVA|||||||0.017
91569197|NCT00935259|183028459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_DEVIATION|52.1||0.455||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||||||0.455
91569198|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.7||||0.014||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 16:00||||0.014
91569199|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 18:3n3||||<0.001
91569200|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.217||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n6||||0.217
91569201|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.666||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n9||||0.666
91569202|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.776||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:5n6||||0.776
91569203|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.018||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:6n3||||0.018
91569204|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.152||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Lysophosphatidylcholine 20:4n6||||0.152
91569205|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.1||||0.007||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 18:2n6||||0.007
91569206|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8||||0.325||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:3n6||||0.325
91569207|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.3||||0.419||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:4n6||||0.419
91569208|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.07||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n3||||0.070
91569209|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.769||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n6||||0.769
91569210|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylethanolamine 18:2n6||||<0.001
91569211|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-240.8||||0.016||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 16:00||||0.016
91569212|NCT00935259|183028460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.833||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 20:3n9||||0.833
91569213|NCT00935259|183028461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.027||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fasted||||0.027
91569214|NCT00935259|183028461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fed||||<0.001
91569215|NCT00935259|183028463|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:4n6 / c20:3n6||||0.247
91569216|NCT00935259|183028463|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:5n3 / c20:4n3||||0.151
91569217|NCT01721746|183028477|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.08|||||From stratified cox proportional hazard model with treatment group as a single covariate, stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (IVRS source)|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.08|0.68|
91569218|NCT01721746|183028478|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.1|0.78|1.36|||||Stratified Cox proportional hazard model.|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.36|0.78|
91569219|NCT01721746|183028479|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.44|3.16||||||For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||3.16|0.44|
91569220|NCT01721746|183028479|SUPERIORITY||Odds Ratio (OR)|5.49|||||TWO_SIDED|95.0|1.92|19.08||||||For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||19.08|1.92|
91569221|NCT01721746|183028480|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.5|1.01|||||From unstratified Cox proportional hazard model|PD-L1 Positive||1.01|0.50|
91569222|NCT01721746|183028481|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.75|1.41|||||From unstratified Cox proportional hazard model|PD-L1 Negative||1.41|0.75|
91569223|NCT03121612|183028483|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.65||||||Threshold for superiority p\<0.05; primary outcome, so not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.65
91569224|NCT03121612|183028483|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 28-33 gestational weeks (n=41). No adjustment for multiple comparisons.||||0.64
91569225|NCT03121612|183028483|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 34-36 gestational weeks (n=10). No adjustment for multiple comparisons.||||1.0
91569226|NCT03121612|183028484|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.8||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution not normal by visual examination, so non-parametric test (Wilcoxon) used."||||0.80
91569227|NCT03121612|183028485|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.86||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.86
91569228|NCT03121612|183028489|SUPERIORITY|||||||1||||||Not adjusted for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
91569229|NCT03121612|183028490|SUPERIORITY|||||||0.33||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational group.||||||0.33
91569230|NCT03121612|183028491|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational age-group.||||||0.31
91569231|NCT03121612|183028492|SUPERIORITY|||||||0.81||||||Not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||||||0.81
91569232|NCT03121612|183028493|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
91569233|NCT03121612|183028499|SUPERIORITY|||||||1||||||No adjustment for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
91569234|NCT03121612|183028501|SUPERIORITY|||||||1|||||||Fisher Exact|No adjustment for multiple comparisons||||||1.0
91569235|NCT01841112|183028503|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3712|||||TWO_SIDED|95.0|0.7272|2.0151|||||The standard error of slope estimate = 0.3038.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||2.0151|0.7272|
91569236|NCT01841112|183028503|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3652|||||TWO_SIDED|95.0|1.0421|1.6883|||||The standard error of slope estimate = 0.1516.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.6883|1.0421|
91569237|NCT01841112|183028504|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1998|||||TWO_SIDED|95.0|0.4794|1.9202|||||The standard error of slope estimate = 0.3380.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.9202|0.4794|
91569238|NCT01841112|183028504|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0299|||||TWO_SIDED|95.0|0.7131|1.3466|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3466|0.7131|
91569239|NCT01841112|183028505|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2015|||||TWO_SIDED|95.0|0.5078|1.8952|||||The standard error of slope estimate = 0.3272.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.8952|0.5078|
91569240|NCT01841112|183028505|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0301|||||TWO_SIDED|95.0|0.7133|1.3469|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3469|0.7133|
91569241|NCT01062269|183028515|SUPERIORITY_OR_OTHER||||||<|0.05||||||Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p\>0.05),then it was removed from the final model.|measures analysis of variance|Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.||"The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an Importance of Acceptability questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations."||||<0.05
91569242|NCT00702546|183028526|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.4|||||TWO_SIDED|95.0|-19.5|0.7||||||Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (\< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).||0.7|-19.5|
91569243|NCT02725008|183028533|SUPERIORITY||Odds Ratio (OR)|2.32||||0.3|TWO_SIDED|95.0|0.54|10.07|||Chi-squared|||||10.07|0.54|0.3
91569244|NCT02725008|183028534|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
91569245|NCT00097669|183028538|SUPERIORITY|"We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.~We used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups."|Risk Ratio (RR)|0.91||||0.05|TWO_SIDED|95.0|0.82|1.0|||Log Rank|||||1.00|0.82|0.05
91569246|NCT00097669|183028538|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.81|1.0|||Regression, Cox|Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.00|0.81|<0.05
91569247|NCT00097669|183028538|SUPERIORITY||Hazard Ratio (HR)|0.91|||<|0.05|TWO_SIDED|95.0|0.81|1.03|||Regression, Cox|Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.03|0.81|<0.05
91569248|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS X axis||||0.098
91569249|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Y axis||||0.389
91569250|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Z axis||||0.780
91569251|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.054
91569252|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point Y axis||||0.323
91569253|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.371
91569254|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level X axis||||0.011
91569255|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.426|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Y axis||||0.426
91569256|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.621|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Z axis||||0.621
91569257|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.275|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale X axis||||0.275
91569258|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Y axis||||0.361
91569259|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Z axis||||0.284
91569260|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale X axis||||0.119
91569261|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Y axis||||0.019
91569262|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Z axis||||0.034
91569263|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious X axis||||0.422
91569264|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Y axis||||0.177
91569265|NCT01473745|183028584|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Z axis||||0.133
91569266|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Intercanthal distance||||0.218
91569267|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance.||nasal height||||0.336
91569268|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance||||||0.192
91569269|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal tip protrusion||||0.135
91569270|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal width||||0.277
91569271|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.505|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.505
91569272|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.299
91569273|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.738
91569274|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.008
91569275|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneious height of upper lip||||0.116
91569276|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.528|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.528
91569277|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.123
91569278|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.250
91569279|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.706
91569280|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.804|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.804
91569281|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.114|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.114
91569282|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal length||||0.457
91569283|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.565|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal tip protrusion||||0.565
91569284|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.781
91569285|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.164
91569286|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.554
91569287|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.508
91569288|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.358
91569289|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.049
91569290|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
91569291|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.062
91569292|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.029
91569293|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.011
91569294|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.211|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.211
91569295|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.102
91569296|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal length||||0.136
91569297|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal tip protrusion||||0.113
91569298|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.115
91569299|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.535
91569300|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.850
91569301|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.891|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.891
91569302|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.262
91569303|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.344|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.344
91569304|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
91569305|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.995
91569306|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.440
91569307|NCT01473745|183028585|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.078
91569308|NCT01473745|183028586|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED|||||intergroup difference of conventional group|t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.104
91569309|NCT01473745|183028586|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||Intergroup difference of modified group|t-test, 2 sided|P value \<0.05 was set as statistical significance.||||||0.043
91569310|NCT01473745|183028586|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.888
91569311|NCT02330276|183028587|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
91569312|NCT02330276|183028588|OTHER|one way ANOVA between groups|Mean Difference (Final Values)|77.9|STANDARD_DEVIATION|11.9|<|0.05|TWO_SIDED|95.0|70.3|85.5||for change in heart rate at 24 hr post-dosing from baseline between the 3 doses|ANOVA|||Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.||85.5|70.3|<0.05
91569313|NCT02330276|183028589|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
91569314|NCT02330276|183028590|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
91569315|NCT02330276|183028591|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
91569316|NCT02034162|183028592|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
91569317|NCT02034162|183028593|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
91569318|NCT02034162|183028595|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91569319|NCT02034162|183028596|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
91569320|NCT00760513|183028602|SUPERIORITY||Mean Difference (Net)|-1.7||||0.48|TWO_SIDED|95.0|-6.3|3.0||The a priori threshold for statistical significance = P\</=0.05|Regression, Linear|Adjusted for baseline value of liver fat percentage||We estimated that a 20% decrease in liver fat with Omacor treatment, assuming a sigma of 0.3, and an alpha of 0.05; with 91 participants completing our trial, we had 86% power to detect a 20% change in liver fat (two tailed test) (see HEPATOLOGY 2014;60:1211-1221).||3.0|-6.3|0.48
91569321|NCT00760513|183028603|SUPERIORITY||Mean Difference (Net)|-0.001||||1|TWO_SIDED|95.0|-0.3|0.3||A priori p value threshold \</=0.5|Regression, Linear|Adjusted for baseline||Based on the available evidence at the time, we assumed that a 0.6-1.0 unit change in fibrosis score might be clinically significant (Hepatology 2008 Feb;47(2):455-460). Consequently, to detect a minimum 0.6 unit change in score (e.g. 9.0 at baseline and 8.4 at the end of the study) with an SD of 1.0, 100 participants would provide \>80% power at the 5% significance level, and with a 15% drop out of participants there would also be \>80% power to detect this effect.||0.3|-0.3|1.0
91569322|NCT00760513|183028604|SUPERIORITY||Mean Difference (Net)|-0.03||||0.9|TWO_SIDED|95.0|-0.4|0.3||A priori threshold for statistical significance p \</=0.05|Regression, Linear|Adjusted for baseline measurement.||There was no power calculation for this end point.||0.3|-0.4|0.9
91569323|NCT00158197|183028605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98|||<|0.01|TWO_SIDED||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
91569324|NCT00158197|183028605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
91569325|NCT00158197|183028605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
91569326|NCT00158197|183028606|SUPERIORITY_OR_OTHER|||||||0.02||||||Yes, the a priori plan to handle post hoc multiple comparisons was to use the method of Bonferroni adjustment. Thus, the new alpha level for these comparisons was \<0.0125.|ANOVA|||||||0.02
91569327|NCT00158197|183028606|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91569328|NCT00158197|183028606|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91569329|NCT00158197|183028606|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
91569330|NCT00158197|183028607|SUPERIORITY_OR_OTHER|||||||0.78|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.78
91569331|NCT00158197|183028607|SUPERIORITY_OR_OTHER|||||||0.68|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.68
91569332|NCT00158197|183028607|SUPERIORITY_OR_OTHER|||||||0.2|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.20
91569333|NCT02808975|183028608|SUPERIORITY||||||=|0.049|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.049
91569334|NCT02808975|183028609|SUPERIORITY||||||=|0.067|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.067
91569335|NCT02808975|183028610|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.003
91569336|NCT02808975|183028611|SUPERIORITY||||||=|0.313|||||||ANCOVA|Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.||||||=0.313
91569337|NCT02808975|183028612|SUPERIORITY||||||=|0.746|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.746
91569338|NCT04367480|183028620|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.81||0.199|TWO_SIDED|95.0|-0.56|2.67|||ANCOVA|||"Missing data were accounted for using multiple imputation (MI) with the fully conditional specification (FCS) method. 100 replicates were imputed.~ANCOVA analysis was applied within each replicate. SAS PROC MI and MIANALYZE were used to calculate the reported estimates. (N: Active TENS=71, Placebo TENS=70)"||2.67|-0.56|0.199
91569339|NCT04367480|183028621|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.302|TWO_SIDED|95.0|-0.34|1.08|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.08|-0.34|0.302
91569340|NCT04367480|183028621|SUPERIORITY||Mean Difference (Final Values)|1.37|STANDARD_ERROR_OF_MEAN|0.85||0.112|TWO_SIDED|95.0|-0.33|3.08|||ANCOVA|||Subgroup analysis on participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22)||3.08|-0.33|0.112
91569341|NCT04367480|183028622|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.35||0.351|TWO_SIDED|95.0|-0.37|1.02|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.02|-0.37|0.351
91569342|NCT04367480|183028622|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.78||0.128|TWO_SIDED|95.0|-0.36|2.79|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)||2.79|-0.36|0.128
91569343|NCT04367480|183028623|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.38||0.166|TWO_SIDED|95.0|-0.22|1.27|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.27|-0.22|0.166
91569344|NCT04367480|183028623|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.39||0.492|TWO_SIDED|95.0|-0.51|1.05|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)||1.05|-0.51|0.492
91569345|NCT04367480|183028624|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.38||0.622|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||0.94|-0.56|0.622
91569346|NCT04367480|183028624|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.43||0.587|TWO_SIDED|95.0|-0.61|1.08|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)||1.08|-0.61|0.587
91569347|NCT04367480|183028625|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-0.02|1.31|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.31|-0.02|0.058
91569348|NCT04367480|183028625|SUPERIORITY||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|0.82||0.11|TWO_SIDED|95.0|-0.32|3.02|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)||3.02|-0.32|0.110
91569349|NCT03382561|183028626|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.17|TWO_SIDED|95.0|0.55|1.11|||Log Rank||Hazard ratio: Arm A (CEN)/Arm B (CE)|||1.11|0.55|0.17
91569350|NCT01076244|183028632|SUPERIORITY_OR_OTHER||change from baseline|13.43|STANDARD_DEVIATION|16.55|<|0.0001|TWO_SIDED|95.0|8.42|18.43|||t-test, 2 sided|||||18.43|8.42|<0.0001
91569351|NCT01076244|183028634|SUPERIORITY_OR_OTHER||change from baseline|2.17|STANDARD_DEVIATION|3.29|<|0.0001|TWO_SIDED|95.0|1.17|3.16|||t-test, 2 sided|||||3.16|1.17|<0.0001
91569352|NCT02641587|183028650|OTHER|"The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|85.01|||<|0.001|TWO_SIDED|95.0|82.06|87.47||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.||87.47|82.06|<0.001
91569353|NCT02641587|183028651|OTHER|"The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|40.2|||<|0.001|TWO_SIDED|95.0|30.25|48.73||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.||48.73|30.25|<0.001
91569354|NCT02641587|183028652|OTHER|"The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|83.9|||<|0.001|TWO_SIDED|95.0|81.61|85.9||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.||85.90|81.61|<0.001
91569355|NCT02641587|183028653|OTHER|"The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|55.74|||<|0.001|TWO_SIDED|95.0|49.03|61.56||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.||61.56|49.03|<0.001
91569356|NCT02641587|183028654|OTHER|"The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|79.36|||<|0.001|TWO_SIDED|95.0|72.73|84.39||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.||84.39|72.73|<0.001
91569357|NCT01150045|183028657|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.12|TWO_SIDED|95.0|0.76|1.03|||Log Rank|||||1.03|0.76|0.12
91569358|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.9|5.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.6|-3.9|
91569359|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|3.3||||||95.0|-7.3|13.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||13.8|-7.3|
91569360|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|2.3||||||95.0|-2.1|7.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.3|-2.1|
91569361|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|-1.6||||||95.0|-8.2|4.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.7|-8.2|
91569362|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|-2.8|9.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-2.8|
91569363|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.5|5.1||||||For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.1|-3.5|
91569364|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|1.1||||||95.0|-8.4|10.6||||||For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||10.6|-8.4|
91569365|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-4.8|9.2||||||For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-4.8|
91569366|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|-1.7||||||95.0|-7.9|4.2||||||For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.2|-7.9|
91569367|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-5.6|9.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.9|-5.6|
91569368|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-9.9|7.6||||||For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.6|-9.9|
91569369|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.0|2.8||||||For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||2.8|-3.0|
91569370|NCT00464945|183028677|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.6|3.5||||||For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||3.5|-3.6|
91569371|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|1.35||||||95.0|1.1|1.65||||||For serotype 4 the GMC ratio was calculated||1.65|1.10|
91569372|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.7|1.31||||||For serotype 6B the GMC ratio was calculated||1.31|0.70|
91569373|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|1.05||||||95.0|0.89|1.24||||||For serotype 9V the GMC ratio was calculated||1.24|0.89|
91569374|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.71|1.22||||||For serotype 14 the GMC ratio was calculated||1.22|0.71|
91569375|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|1.06||||||95.0|0.86|1.3||||||For serotype 18C the GMC ratio was calculated||1.30|0.86|
91569376|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.98||||||95.0|0.81|1.17||||||For serotype 19F the GMC ratio was calculated||1.17|0.81|
91569377|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.9||||||95.0|0.7|1.15||||||For serotype 23F the GMC ratio was calculated||1.15|0.70|
91569378|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|1.1||||||95.0|0.88|1.37||||||For serotype 1 the GMC ratio was calculated||1.37|0.88|
91569379|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|1.0||||||95.0|0.83|1.2||||||For serotype 3 the GMC ratio was calculated||1.20|0.83|
91569380|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.16||||||For serotype 5 the GMC ratio was calculated||1.16|0.79|
91569381|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.66|1.05||||||For serotype 6A the GMC ratio was calculated||1.05|0.66|
91569382|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.79|1.11||||||For serotype 7F the GMC ratio was calculated||1.11|0.79|
91569383|NCT00464945|183028681|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.13||||||For serotype 19A the GMC ratio was calculated||1.13|0.79|
91569384|NCT03831854|183028682|SUPERIORITY||Median Difference (Final Values)|0.0||||0.08|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.08
91569385|NCT03831854|183028683|SUPERIORITY|||||||0.11|||||||Fisher Exact|The relative risk could not be assessed due to zero incidence in the treatment group||||||0.11
91569386|NCT03831854|183028684|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.63|TWO_SIDED|98.5|-9.5|5.0|||Wilcoxon (Mann-Whitney)|||||5.0|-9.5|0.63
91569387|NCT03831854|183028685|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.58|TWO_SIDED|98.3|-1.7|2.6|||t-test, 2 sided|||||2.6|-1.7|0.58
91569388|NCT03831854|183028686|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|98.3|0.3|3.8|||Chi-squared|||||3.8|0.3|1.0
91569389|NCT02094898|183028692|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569390|NCT02094898|183028692|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
91569391|NCT02094898|183028693|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
91569392|NCT02094898|183028694|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569393|NCT02094898|183028694|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569394|NCT02094898|183028694|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
91569395|NCT02094898|183028695|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
91569396|NCT02094898|183028696|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569397|NCT02094898|183028696|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
91569398|NCT02094898|183028697|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569399|NCT02094898|183028698|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569400|NCT02094898|183028698|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569401|NCT02094898|183028699|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569402|NCT02094898|183028700|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
91569403|NCT02094898|183028700|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
91569404|NCT02094898|183028701|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
91569405|NCT02094898|183028702|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
91569406|NCT02094898|183028702|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
91569407|NCT02094898|183028703|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
91569408|NCT02094898|183028704|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569409|NCT02094898|183028704|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
91569410|NCT03520075|183028716|SUPERIORITY||Geometric Least Squares Mean (Geo LSM)|27.8|||||TWO_SIDED|90.0|8.5|91.2|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||91.2|8.50|
91569411|NCT03520075|183028716|SUPERIORITY||Geo LSM|38.8|||||TWO_SIDED|90.0|11.4|132.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||132|11.4|
91569412|NCT03520075|183028716|SUPERIORITY||Geo LSM|58.9|||||TWO_SIDED|90.0|15.7|222.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||222|15.7|
91569413|NCT03520075|183028716|SUPERIORITY||Geo LSM|47.2|||||TWO_SIDED|90.0|20.7|108.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||108|20.7|
91569414|NCT03520075|183028717|SUPERIORITY||Geo LSM|18.1|||||TWO_SIDED|90.0|5.28|61.9|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||61.9|5.28|
91569415|NCT03520075|183028717|SUPERIORITY||Geo LSM|44.1|||||TWO_SIDED|90.0|8.32|234.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||234|8.32|
91569416|NCT03520075|183028717|SUPERIORITY||Geo LSM|58.7|||||TWO_SIDED|90.0|15.7|220.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||220|15.7|
91569417|NCT03520075|183028717|SUPERIORITY||Geo LSM|40.2|||||TWO_SIDED|90.0|14.3|113.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||113|14.3|
91569418|NCT03520075|183028718|SUPERIORITY||Geo LSM|17.5|||||TWO_SIDED|90.0|5.62|54.3|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||54.3|5.62|
91569419|NCT03520075|183028718|SUPERIORITY||Geo LSM|34.5|||||TWO_SIDED|90.0|12.0|99.4|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||99.4|12.0|
91569420|NCT03520075|183028718|SUPERIORITY||Geo LSM|72.6|||||TWO_SIDED|90.0|17.6|299.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||299|17.6|
91569421|NCT03520075|183028718|SUPERIORITY||Geo LSM|72.5|||||TWO_SIDED|90.0|29.1|181.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||181|29.1|
91569422|NCT03520075|183028719|SUPERIORITY||Hodges-Lehmann Estimator|-2.275||||0.0388671|TWO_SIDED|90.0|-5.216|-0.083|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% confidence interval (CI) was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||-0.0830|-5.2160|0.0388671
91569423|NCT03520075|183028719|SUPERIORITY||Hodges-Lehmann Estimator|1.45||||0.4795001|TWO_SIDED|90.0|-0.917|5.15|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||5.1500|-0.9170|0.4795001
91569424|NCT03520075|183028719|SUPERIORITY||Hodges-Lehmann Estimator|-0.45||||0.8272593|TWO_SIDED|90.0|-2.467|0.95|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||0.9500|-2.4670|0.8272593
91569425|NCT03520075|183028719|SUPERIORITY||Hodges-Lehmann Estimator|0.583||||0.5126908|TWO_SIDED|90.0|-6.45|3.5|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||3.5000|-6.4500|0.5126908
91569426|NCT03305809|183028739|SUPERIORITY||Posterior Mean Difference|-0.89|||||TWO_SIDED|95.0|-2.776|0.969|||||Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.|||0.969|-2.776|
91569427|NCT03305809|183028739|SUPERIORITY||Posterior Mean Difference|-0.08|||||TWO_SIDED|95.0|-1.996|1.879|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.879|-1.996|
91569428|NCT03305809|183028739|SUPERIORITY||Posterior Mean Difference|-0.78|||||TWO_SIDED|95.0|-2.873|1.277|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.277|-2.873|
91569429|NCT03305809|183028740|SUPERIORITY||Mean Difference (Net)|-0.2||||0.273|TWO_SIDED|95.0|-0.54|0.15|||Mixed Models Analysis|||||0.15|-0.54|0.273
91569430|NCT03305809|183028740|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||Mixed Models Analysis|||||-0.30|-1.02|<0.001
91569431|NCT03305809|183028740|SUPERIORITY||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.29|-0.53|||Mixed Models Analysis|||||-0.53|-1.29|< 0.001
91569432|NCT03305809|183028741|SUPERIORITY||Mean Difference (Net)|-70.71|STANDARD_ERROR_OF_MEAN|68.495||0.303|TWO_SIDED|95.0|-205.53|64.11|||Mixed Models Analysis|||||64.11|-205.53|0.303
91569433|NCT03305809|183028741|SUPERIORITY||Median Difference (Net)|-107.02|STANDARD_ERROR_OF_MEAN|69.647||0.125|TWO_SIDED|95.0|-244.09|30.06|||Mixed Models Analysis|||||30.06|-244.09|0.125
91569434|NCT03305809|183028741|SUPERIORITY||Mean Difference (Net)|-123.72|STANDARD_ERROR_OF_MEAN|72.892||0.091|TWO_SIDED|95.0|-267.18|19.74|||Mixed Models Analysis|||||19.74|-267.18|0.091
91569435|NCT03305809|183028742|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.985||0.686|TWO_SIDED|95.0|-2.34|1.54|||Mixed Models Analysis|||||1.54|-2.34|0.686
91569436|NCT03305809|183028742|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.011||0.485|TWO_SIDED|95.0|-2.7|1.28|||Mixed Models Analysis|||||1.28|-2.70|0.485
91569437|NCT03305809|183028742|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.064||0.406|TWO_SIDED|95.0|-2.98|1.21|||Mixed Models Analysis|||||1.21|-2.98|0.406
91569438|NCT03305809|183028743|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.603||0.464|TWO_SIDED|95.0|-0.74|1.63|||Mixed Models Analysis|||||1.63|-0.74|0.464
91569439|NCT03305809|183028743|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.623||0.72|TWO_SIDED|95.0|-1.0|1.45|||Mixed Models Analysis|||||1.45|-1.00|0.720
91569440|NCT03305809|183028743|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.655||0.149|TWO_SIDED|95.0|-0.34|2.24|||Mixed Models Analysis|||||2.24|-0.34|0.149
91569441|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.213||0.607|TWO_SIDED|95.0|-3.01|1.76|||Mixed Models Analysis|||Total Score||1.76|-3.01|0.607
91569442|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.265||0.18|TWO_SIDED|95.0|-4.19|0.79|||Mixed Models Analysis|||Total Score||0.79|-4.19|0.180
91569443|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.75|STANDARD_ERROR_OF_MEAN|1.325||0.572|TWO_SIDED|95.0|-3.36|1.86|||Mixed Models Analysis|||Total Score||1.86|-3.36|0.572
91569444|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.173||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||Delusions||0.17|-0.51|0.320
91569445|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|-0.73|-0.02|||Mixed Models Analysis|||Delusions||-0.02|-0.73|0.037
91569446|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.558|TWO_SIDED|95.0|-0.49|0.26|||Mixed Models Analysis|||Delusions||0.26|-0.49|0.558
91569447|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.182||0.924|TWO_SIDED|95.0|-0.38|0.34|||Mixed Models Analysis|||Hallucinations||0.34|-0.38|0.924
91569448|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.189||0.061|TWO_SIDED|95.0|-0.73|0.02|||Mixed Models Analysis|||Hallucinations||0.02|-0.73|0.061
91569449|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.199||0.148|TWO_SIDED|95.0|-0.68|0.1|||Mixed Models Analysis|||Hallucinations||0.10|-0.68|0.148
91569450|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.552|TWO_SIDED|95.0|-0.46|0.25|||Mixed Models Analysis|||Agitation/Aggression||0.25|-0.46|0.552
91569451|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.188||0.735|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Agitation/Aggression||0.31|-0.43|0.735
91569452|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.197||0.224|TWO_SIDED|95.0|-0.63|0.15|||Mixed Models Analysis|||Agitation/Aggression||0.15|-0.63|0.224
91569453|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.216||0.783|TWO_SIDED|95.0|-0.37|0.48|||Mixed Models Analysis|||Depression/Dysphoria||0.48|-0.37|0.783
91569454|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.226||0.64|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.55|0.640
91569455|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.236||0.592|TWO_SIDED|95.0|-0.59|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.59|0.592
91569456|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.197||0.993|TWO_SIDED|95.0|-0.39|0.39|||Mixed Models Analysis|||Anxiety||0.39|-0.39|0.993
91569457|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.205||0.29|TWO_SIDED|95.0|-0.19|0.62|||Mixed Models Analysis|||Anxiety||0.62|-0.19|0.290
91569458|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.215||0.722|TWO_SIDED|95.0|-0.5|0.35|||Mixed Models Analysis|||Anxiety||0.35|-0.50|0.722
91569459|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.246|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||Elation/Euphoria||0.08|-0.30|0.246
91569460|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.175|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||Elation/Euphoria||0.06|-0.34|0.175
91569461|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.106||0.482|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|||Elation/Euphoria||0.13|-0.28|0.482
91569462|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.266||0.091|TWO_SIDED|95.0|-0.97|0.07|||Mixed Models Analysis|||Apathy/Indifference||0.07|-0.97|0.091
91569463|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.278||0.248|TWO_SIDED|95.0|-0.87|0.23|||Mixed Models Analysis|||Apathy/Indifference||0.23|-0.87|0.248
91569464|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.29||0.516|TWO_SIDED|95.0|-0.76|0.38|||Mixed Models Analysis|||Apathy/Indifference||0.38|-0.76|0.516
91569465|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.114||0.875|TWO_SIDED|95.0|-0.21|0.24|||Mixed Models Analysis|||Disinhibition||0.24|-0.21|0.875
91569466|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.119||0.005|TWO_SIDED|95.0|0.1|0.57|||Mixed Models Analysis|||Disinhibition||0.57|0.10|0.005
91569467|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.125||0.761|TWO_SIDED|95.0|-0.21|0.28|||Mixed Models Analysis|||Disinhibition||0.28|-0.21|0.761
91569468|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.181||0.183|TWO_SIDED|95.0|-0.6|0.12|||Mixed Models Analysis|||Irritability/Lability||0.12|-0.60|0.183
91569469|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.189||0.765|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Irritability/Lability||0.31|-0.43|0.765
91569470|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.198||0.279|TWO_SIDED|95.0|-0.18|0.61|||Mixed Models Analysis|||Irritability/Lability||0.61|-0.18|0.279
91569471|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.147||0.252|TWO_SIDED|95.0|-0.12|0.46|||Mixed Models Analysis|||Aberrant Motor Behavior||0.46|-0.12|0.252
91569472|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.526|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Aberrant Motor Behavior||0.20|-0.40|0.526
91569473|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.161||0.8|TWO_SIDED|95.0|-0.28|0.36|||Mixed Models Analysis|||Aberrant Motor Behavior||0.36|-0.28|0.800
91569474|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.623|TWO_SIDED|95.0|-0.59|0.98|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.98|-0.59|0.623
91569475|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.418||0.354|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.44|-1.21|0.354
91569476|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.437||0.809|TWO_SIDED|95.0|-0.97|0.75|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.75|-0.97|0.809
91569477|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.376||0.79|TWO_SIDED|95.0|-0.84|0.64|||Mixed Models Analysis|||Appetite/Eating Disorders||0.64|-0.84|0.790
91569478|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.392||0.28|TWO_SIDED|95.0|-1.2|0.35|||Mixed Models Analysis|||Appetite/Eating Disorders||0.35|-1.20|0.280
91569479|NCT03305809|183028744|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.412||0.797|TWO_SIDED|95.0|-0.7|0.92|||Mixed Models Analysis|||Appetite/Eating Disorders||0.92|-0.70|0.797
91569480|NCT03305809|183028745|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.247|TWO_SIDED|95.0|-1.91|0.49|||Mixed Models Analysis|||||0.49|-1.91|0.247
91569481|NCT03305809|183028745|SUPERIORITY||Mean Difference (Net)|-0.88|STANDARD_ERROR_OF_MEAN|0.631||0.164|TWO_SIDED|95.0|-2.12|0.36|||Mixed Models Analysis|||||0.36|-2.12|0.164
91569482|NCT03305809|183028745|SUPERIORITY||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|0.663||0.017|TWO_SIDED|95.0|-2.9|-0.29|||Mixed Models Analysis|||||-0.29|-2.90|0.017
91569483|NCT03305809|183028746|SUPERIORITY||Mean Difference (Net)|-6.41|STANDARD_ERROR_OF_MEAN|2.86||0.026|TWO_SIDED|95.0|-12.04|-0.77|||Mixed Models Analysis|||||-0.77|-12.04|0.026
91569484|NCT03305809|183028746|SUPERIORITY||Mean Difference (Net)|-7.39|STANDARD_ERROR_OF_MEAN|2.969||0.014|TWO_SIDED|95.0|-13.24|-1.53|||Mixed Models Analysis|||||-1.53|-13.24|0.014
91569485|NCT03305809|183028746|SUPERIORITY||Mean Difference (Net)|-10.6|STANDARD_ERROR_OF_MEAN|3.104|<|0.001|TWO_SIDED|95.0|-16.72|-4.48|||Mixed Models Analysis|||||-4.48|-16.72|<0.001
91569486|NCT03305809|183028747|SUPERIORITY||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.362||0.683|TWO_SIDED|95.0|-2.13|3.24|||Mixed Models Analysis|||||3.24|-2.13|0.683
91569487|NCT03305809|183028747|SUPERIORITY||Mean Difference (Net)|2.41|STANDARD_ERROR_OF_MEAN|1.413||0.089|TWO_SIDED|95.0|-0.37|5.19|||Mixed Models Analysis|||||5.19|-0.37|0.089
91569488|NCT03305809|183028747|SUPERIORITY||Mean Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|1.489||0.294|TWO_SIDED|95.0|-1.37|4.49|||Mixed Models Analysis|||||4.49|-1.37|0.294
91569489|NCT03305809|183028748|SUPERIORITY||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.389||0.105|TWO_SIDED|95.0|-0.13|1.4|||Mixed Models Analysis|||||1.40|-0.13|0.105
91569490|NCT03305809|183028748|SUPERIORITY||Mean Difference (Net)|1.07|STANDARD_ERROR_OF_MEAN|0.406||0.009|TWO_SIDED|95.0|0.27|1.87|||Mixed Models Analysis|||||1.87|0.27|0.009
91569491|NCT03305809|183028748|SUPERIORITY||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|0.428||0.253|TWO_SIDED|95.0|-0.35|1.33|||Mixed Models Analysis|||||1.33|-0.35|0.253
91569492|NCT03305809|183028749|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_ERROR_OF_MEAN|0.923||0.061|TWO_SIDED|95.0|-3.56|0.08|||Mixed Models Analysis|||Motor Experiences of Daily Living||0.08|-3.56|0.061
91569493|NCT03305809|183028749|SUPERIORITY||Mean Difference (Net)|-2.37|STANDARD_ERROR_OF_MEAN|0.96||0.014|TWO_SIDED|95.0|-4.26|-0.47|||Mixed Models Analysis|||Motor Experiences of Daily Living||-0.47|-4.26|0.014
91569494|NCT03305809|183028749|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|1.013|<|0.001|TWO_SIDED|95.0|-5.5|-1.51|||Mixed Models Analysis|||Motor Experiences of Daily Living||-1.51|-5.50|<0.001
91569495|NCT03305809|183028749|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.822||0.074|TWO_SIDED|95.0|-6.86|0.32|||Mixed Models Analysis|||Motor Exam||0.32|-6.86|0.074
91569496|NCT03305809|183028749|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.891||0.085|TWO_SIDED|95.0|-7.0|0.45|||Mixed Models Analysis|||Motor Exam||0.45|-7.00|0.085
91569497|NCT03305809|183028749|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|1.959||0.032|TWO_SIDED|95.0|-8.09|-0.37|||Mixed Models Analysis|||Motor Exam||-0.37|-8.09|0.032
91569498|NCT03305809|183028751|SUPERIORITY||Mean Difference (Net)|0.3||||0.898|TWO_SIDED|95.0|-4.92|5.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.61|-4.92|0.898
91569499|NCT03305809|183028751|SUPERIORITY||Mean Difference (Net)|0.6||||0.821|TWO_SIDED|95.0|-4.71|5.94|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.94|-4.71|0.821
91569500|NCT03305809|183028751|SUPERIORITY||Mean Difference (Net)|9.4|||<|0.001|TWO_SIDED|95.0|4.11|14.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||14.61|4.11|<0.001
91569501|NCT03305809|183028751|SUPERIORITY||Mean Difference (Net)|0.3||||0.805|TWO_SIDED|95.0|-2.4|3.08|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.08|-2.40|0.805
91569502|NCT03305809|183028751|SUPERIORITY||Mean Difference (Net)|0.9||||0.513|TWO_SIDED|95.0|-1.85|3.69|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.69|-1.85|0.513
91569503|NCT03305809|183028751|SUPERIORITY||Mean Difference (Net)|3.6||||0.011|TWO_SIDED|95.0|0.83|6.28|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||6.28|0.83|0.011
91569504|NCT03305809|183028752|SUPERIORITY||Mean Difference (Net)|2.5||||0.065|TWO_SIDED|95.0|-0.16|5.08|||Mixed Models Analysis|||||5.08|-0.16|0.065
91569505|NCT03305809|183028752|SUPERIORITY||Mean Difference (Net)|3.6||||0.008|TWO_SIDED|95.0|0.93|6.21|||Mixed Models Analysis|||||6.21|0.93|0.008
91569506|NCT03305809|183028752|SUPERIORITY||Mean Difference (Net)|8.7|||<|0.001|TWO_SIDED|95.0|6.06|11.27|||Mixed Models Analysis|||||11.27|6.06|<0.001
91569507|NCT03305809|183028753|SUPERIORITY||Mean Difference (Net)|1.6||||0.339|TWO_SIDED|95.0|-1.72|4.99|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.99|-1.72|0.339
91569508|NCT03305809|183028753|SUPERIORITY||Mean Difference (Net)|1.2||||0.486|TWO_SIDED|95.0|-2.26|4.73|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.73|-2.26|0.486
91569509|NCT03305809|183028753|SUPERIORITY||Mean Difference (Net)|4.2||||0.024|TWO_SIDED|95.0|0.56|7.81|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||7.81|0.56|0.024
91569510|NCT03305809|183028753|SUPERIORITY||Mean Difference (Net)|-0.1||||0.935|TWO_SIDED|95.0|-2.04|1.88|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.88|-2.04|0.935
91569511|NCT03305809|183028753|SUPERIORITY||Mean Difference (Net)|0.7||||0.505|TWO_SIDED|95.0|-1.34|2.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||2.72|-1.34|0.505
91569512|NCT03305809|183028753|SUPERIORITY||Mean Difference (Net)|1.22||||0.266|TWO_SIDED|95.0|-0.91|3.3|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.30|-0.91|0.266
91569513|NCT03305809|183028754|SUPERIORITY||Mean Difference (Net)|0.6||||0.55|TWO_SIDED|95.0|-1.28|2.41|||Mixed Models Analysis|||||2.41|-1.28|0.550
91569514|NCT03305809|183028754|SUPERIORITY||Mean Difference (Net)|1.8||||0.069|TWO_SIDED|95.0|-0.14|3.68|||Mixed Models Analysis|||||3.68|-0.14|0.069
91569515|NCT03305809|183028754|SUPERIORITY||Mean Difference (Net)|2.9||||0.005|TWO_SIDED|95.0|0.89|4.83|||Mixed Models Analysis|||||4.83|0.89|0.005
91569516|NCT03305809|183028755|SUPERIORITY||Mean Difference (Net)|-7.0||||0.045|TWO_SIDED|95.0|-13.92|-0.15|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||-0.15|-13.92|0.045
91569517|NCT03305809|183028755|SUPERIORITY||Mean Difference (Net)|3.1||||0.39|TWO_SIDED|95.0|-4.05|10.32|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||10.32|-4.05|0.390
91569518|NCT03305809|183028755|SUPERIORITY||Mean Difference (Net)|-1.1||||0.768|TWO_SIDED|95.0|-8.32|6.16|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||6.16|-8.32|0.768
91569519|NCT03305809|183028755|SUPERIORITY||Mean Difference (Net)|-4.3||||0.041|TWO_SIDED|95.0|-8.48|-0.17|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||-0.17|-8.48|0.041
91569520|NCT03305809|183028755|SUPERIORITY||Mean Difference (Net)|-0.5||||0.802|TWO_SIDED|95.0|-4.81|3.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.72|-4.81|0.802
91569521|NCT03305809|183028755|SUPERIORITY||Mean Difference (Net)|-2.4||||0.284|TWO_SIDED|95.0|-6.67|1.97|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.97|-6.67|0.284
91569522|NCT03305809|183028756|SUPERIORITY||Mean Difference (Net)|0.0||||0.996|TWO_SIDED|95.0|-4.17|4.19|||Mixed Models Analysis|||||4.19|-4.17|0.996
91569523|NCT03305809|183028756|SUPERIORITY||Mean Difference (Net)|-0.7||||0.767|TWO_SIDED|95.0|-4.99|3.69|||Mixed Models Analysis|||||3.69|-4.99|0.767
91569524|NCT03305809|183028756|SUPERIORITY||Mean Difference (Net)|-0.6||||0.791|TWO_SIDED|95.0|-4.96|3.79|||Mixed Models Analysis|||||3.79|-4.96|0.791
91569525|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|0.98||||0.312|TWO_SIDED|95.0|-0.93|2.88|||ANCOVA|||Week 12||2.88|-0.93|0.312
91569526|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|1.03||||0.289|TWO_SIDED|95.0|-0.89|2.95|||ANCOVA|||Week 12||2.95|-0.89|0.289
91569527|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|1.56||||0.141|TWO_SIDED|95.0|-0.53|3.65|||ANCOVA|||Week 12||3.65|-0.53|0.141
91569528|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|0.06||||0.954|TWO_SIDED|95.0|-1.89|2.01|||ANCOVA|||Week 12||2.01|-1.89|0.954
91569529|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|0.59||||0.584|TWO_SIDED|95.0|-1.53|2.7|||ANCOVA|||||2.70|-1.53|0.584
91569530|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|0.53||||0.623|TWO_SIDED|95.0|-1.59|2.65|||ANCOVA|||Week 12||2.65|-1.59|0.623
91569531|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|1.39||||0.256|TWO_SIDED|95.0|-1.02|3.79|||ANCOVA|||Follow-up||3.79|-1.02|0.256
91569532|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|1.41||||0.258|TWO_SIDED|95.0|-1.04|3.86|||ANCOVA|||Follow-up||3.86|-1.04|0.258
91569533|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|4.59|||<|0.001|TWO_SIDED|95.0|1.93|7.25|||ANCOVA|||Follow-up||7.25|1.93|<0.001
91569534|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|0.02||||0.988|TWO_SIDED|95.0|-2.47|2.51|||ANCOVA|||Follow-up||2.51|-2.47|0.988
91569535|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|3.2||||0.02|TWO_SIDED|95.0|0.51|5.9|||ANCOVA|||Follow-up||5.90|0.51|0.020
91569536|NCT03305809|183028757|SUPERIORITY||Mean Difference (Net)|3.18||||0.022|TWO_SIDED|95.0|0.46|5.91|||ANCOVA|||Follow-up||5.91|0.46|0.022
91569537|NCT05146206|183028759|OTHER||||||<|0.001|||||||ANOVA|||||||<.001
91569538|NCT05146206|183028760|OTHER||||||<|0.001|||||||MANOVA|||||||<0.001
91569539|NCT00816556|183028761|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||Dryness severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.42
91569540|NCT00816556|183028761|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Dryness bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.22
91569541|NCT00816556|183028761|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANOVA|||Itching severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.37
91569542|NCT00816556|183028761|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||Itching bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.27
91569543|NCT00816556|183028761|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Burning severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.46
91569544|NCT00816556|183028761|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|||Burning bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.67
91569545|NCT00816556|183028762|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.33
91569546|NCT00816556|183028762|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.99
91569547|NCT00816556|183028762|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.58
91569548|NCT00816556|183028763|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.007
91569549|NCT00816556|183028763|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.32
91569550|NCT00816556|183028763|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.02
91569551|NCT02007200|183028764|SUPERIORITY_OR_OTHER||||||<|0.005|||||||Linear Repeated Measures Model|||||||<0.005
91569552|NCT01657799|183028770|SUPERIORITY|||||||0.933|||||||Log Rank|Log-rank test stratified by graded prognostic assessment (GPA) score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.933
91569553|NCT01657799|183028770|SUPERIORITY|||||||0.909|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.909
91569554|NCT01657799|183028770|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.927|TWO_SIDED|95.0|0.716|1.355|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.355|0.716|0.927
91569555|NCT01657799|183028770|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.906|TWO_SIDED|95.0|0.71|1.354|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.354|0.710|0.906
91569556|NCT01657799|183028771|SUPERIORITY|||||||0.535|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.535
91569557|NCT01657799|183028771|SUPERIORITY|||||||0.898|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.898
91569558|NCT01657799|183028772|SUPERIORITY|||||||0.314|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.314
91569559|NCT01657799|183028772|SUPERIORITY|||||||0.536|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.536
91569560|NCT01657799|183028772|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.313|TWO_SIDED|95.0|0.78|2.168|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.168|0.780|0.313
91569561|NCT01657799|183028772|SUPERIORITY||Hazard Ratio (HR)|1.181||||0.534|TWO_SIDED|95.0|0.698|1.999|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.999|0.698|0.534
91569562|NCT01657799|183028773|SUPERIORITY|||||||0.864|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.864
91569563|NCT01657799|183028773|SUPERIORITY|||||||0.301|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.301
91569564|NCT01657799|183028773|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.86|TWO_SIDED|95.0|0.626|1.754|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.754|0.626|0.860
91569565|NCT01657799|183028773|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.289|TWO_SIDED|95.0|0.803|2.086|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.086|0.803|0.289
91569566|NCT04962698|183028786|SUPERIORITY||||||>|0.00238||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||>0.00238
91569567|NCT04962698|183028787|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was 0.05.|ANOVA|||||||<0.001
91569568|NCT04962698|183028788|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was 0.05.|ANOVA|||||||0.028
91569569|NCT04962698|183028789|SUPERIORITY||||||<|0.00231||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.00231
91569570|NCT04962698|183028790|SUPERIORITY||||||<|0.002||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.0020
91569571|NCT00364377|183028795|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student's two-tailed t-test for paired samples. Between-group comparisons were made using Student's two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose||||>0.05
91569572|NCT01121913|183028816|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
91569573|NCT01121913|183028816|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|105.0|||||TWO_SIDED|90.0|93.9|117.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||117|93.9|
91569574|NCT01121913|183028816|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|95.3|||||TWO_SIDED|90.0|85.5|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.5|
91569575|NCT01121913|183028816|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|97.7|||||TWO_SIDED|90.0|87.7|109.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||109|87.7|
91569576|NCT01121913|183028817|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
91569577|NCT01121913|183028817|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|106.0|||||TWO_SIDED|90.0|95.1|118.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||118|95.1|
91569578|NCT01121913|183028817|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|94.9|||||TWO_SIDED|90.0|85.1|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.1|
91569579|NCT01121913|183028817|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|98.4|||||TWO_SIDED|90.0|88.3|110.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||110|88.3|
91569580|NCT01121913|183028818|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|73.3|||||TWO_SIDED|90.0|63.2|85.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||85|63.2|
91569581|NCT01121913|183028818|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|59.8|||||TWO_SIDED|90.0|51.5|69.4|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||69.4|51.5|
91569582|NCT01121913|183028818|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|83.0|||||TWO_SIDED|90.0|71.5|96.4|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||96.4|71.5|
91569583|NCT01121913|183028818|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|67.7|||||TWO_SIDED|90.0|58.4|78.5|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||78.5|58.4|
91569584|NCT05043883|183028823|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome specificity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage (%)|87.0||||0.006|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the specificity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Specificity is the ability to correctly detect true negative values of the ground-truth negative EGM classifications. The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that specificity is lower or equal to the superiority limit 80%.||||0.006
91569585|NCT05043883|183028823|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome Sensitivity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage|86.0||||0.004|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the sensitivity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Sensitivity of the PVI analyzer is determined by the capability to detect true positive among all ground-truth positive EGM classifications.The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that sensitivity is lower or equal to the superiority limit 80%.||||0.004
91569586|NCT05043883|183028824|OTHER|Descriptive|Percentage|0.99|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.02|5.39|||||Only one AE was reported for one subject ( which was considered moderate in severity and not related to the device, but related to the SOC procedure.|A descriptive analysis was performed to evaluate the AEs and device deficiencies, estimating the percentages and 95% CI on each category.||5.39|0.02|
91569587|NCT05043883|183028825|SUPERIORITY||Percentage (%)|94.0||||2e-05|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.00002
91569588|NCT05043883|183028825|SUPERIORITY||Percentage (%)|82.0||||0.32|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.32
91569589|NCT05043883|183028825|SUPERIORITY||Percentage (%)|79.0||||0.66|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.66
91569590|NCT05043883|183028825|SUPERIORITY||Percentage (%)|92.0||||0.0008|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.0008
91569591|NCT05043883|183028826|SUPERIORITY||Percentage (%)|96.0||||5e-06|TWO_SIDED|||||To compute the proportional agreement between two non-overlapping samples, a one-sample Z-test was performed with the alternative hypothesis that agreement was above 90%, which was considered sufficient for a real-time assessment.|Z-test|||This endpoint used the same EGMs extracted for the primary endpoint, including only EGMs from T Baseline and T Final measurements from patients in sinus rhythm.||||0.000005
91569592|NCT05043883|183028827|SUPERIORITY||Percentage (%)|54.0||||1|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the specificity are below 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||1
91569593|NCT05043883|183028827|SUPERIORITY||Percentage (%)|100.0||||0.0007|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the sensitivity are below 80% and an alternative hypothesis that sensitivity is at or above 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||0.0007
91569594|NCT05043883|183028828|SUPERIORITY||Percentage (%)|87.0||||0.04|TWO_SIDED||||||Z-test|The estimate was done using a one-sample Z-test with a null hypothesis that sensitivity is at or below 80% and a 95% significance level.||This secondary endpoint aimed to determine the sensitivity of the PVI Analyzer at the time of isolation, which requires the EGMs at the T PVI. A Z-test for sensitivity was performed to assess the sensitivity of the PVI Analyzer analysis to identify expert-defined isolation during the PVI ablation.||||0.04
91569595|NCT05043883|183028829|OTHER|||||||0.0002||||||McNemar test assumes as a null hypothesis that the two datasets cause the PVI Analyzer to have a similar proportion of errors.|McNemars test|A paired McNemars test with an alpha value of 0.05, was applied to analyze the differences in classification performance.||A paired McNemar's Chi-Square test was performed to analyze the differences in classification performances||||0.0002
91569596|NCT03559829|183028865|OTHER|||||||0.025|||||||paired t-test|||||||0.025
91569597|NCT03559829|183028866|OTHER|||||||0.01|||||||paired t-test|||||||0.01
91569598|NCT03559829|183028867|OTHER|||||||0.3|||||||paired t-test|||||||0.3
91569599|NCT03559829|183028868|OTHER|||||||0.098|||||||paired t-test|||||||0.098
91569600|NCT03559829|183028869|OTHER|||||||0.2|||||||paired t-test|||||||0.2
91569601|NCT03559829|183028870|OTHER|||||||0.07|||||||paired t-test|||||||0.07
91569602|NCT03506347|183028872|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
91569603|NCT03506347|183028873|SUPERIORITY|||||||0.009|||||||ANOVA|||||||0.009
91569604|NCT03783546|183028874|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
91569605|NCT03783546|183028876|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
91569606|NCT04522778|183028967|OTHER|||||||0.029|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.029
91569607|NCT04522778|183028968|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.35
91569608|NCT04522778|183028969|SUPERIORITY|||||||0.334|||||||t-test, 1 sided|||||||.334
91569609|NCT04522778|183028970|SUPERIORITY||Odds Ratio (OR)|38.26|STANDARD_ERROR_OF_MEAN|50.195||0.005|TWO_SIDED|95.0|2.926154|500.4402|||Chi-squared|||||500.4402|2.926154|.005
91569610|NCT04522778|183028971|SUPERIORITY||Odds Ratio (OR)|30.975|STANDARD_ERROR_OF_MEAN|35.73483||0.003|TWO_SIDED|95.0|3.22|297.17|||Chi-squared|||||297.17|3.22|.003
91569611|NCT04522778|183028972|SUPERIORITY||Odds Ratio (OR)|27.36|STANDARD_ERROR_OF_MEAN|31.72||0.004|TWO_SIDED|95.0|2.82|265.45|||Chi-squared|||||265.45|2.82|.004
91569612|NCT04522778|183028973|SUPERIORITY||Odds Ratio (OR)|10.93|STANDARD_ERROR_OF_MEAN|10.345||0.011|TWO_SIDED|95.0|1.71|69.82|||Chi-squared|||||69.82|1.71|.011
91569613|NCT04522778|183028974|SUPERIORITY||Odds Ratio (OR)|0.298|STANDARD_ERROR_OF_MEAN|0.2189||0.099|TWO_SIDED|95.0|0.0706|1.258|||Chi-squared|||||1.258|.0706|.099
91569614|NCT04522778|183028975|SUPERIORITY||Odds Ratio (OR)|1.201|STANDARD_ERROR_OF_MEAN|1.201||0.312|TWO_SIDED|95.0|0.549|6.562|||Chi-squared|||||6.562|.549|.312
91569615|NCT04522778|183028976|SUPERIORITY||Odds Ratio (OR)|1.519|STANDARD_ERROR_OF_MEAN|2.022||0.753|TWO_SIDED|95.0|0.112|20.623|||Chi-squared|||||20.623|.112|.753
91569616|NCT04522778|183028977|SUPERIORITY||Odds Ratio (OR)|0.321|STANDARD_ERROR_OF_MEAN|0.257||0.156|TWO_SIDED|95.0|0.067|1.541|||Chi-squared|||||1.541|.067|.156
91569617|NCT04522778|183028978|SUPERIORITY||Odds Ratio (OR)|0.458|STANDARD_ERROR_OF_MEAN|0.358||0.318|TWO_SIDED|95.0|0.099|2.122|||Chi-squared|||||2.122|.099|.318
91569618|NCT04522778|183028979|SUPERIORITY||Odds Ratio (OR)|0.449|STANDARD_ERROR_OF_MEAN|0.882||0.684|TWO_SIDED|95.0|0.009|21.003|||Chi-squared|||||21.003|.009|.684
91569619|NCT04522778|183028980|SUPERIORITY||Odds Ratio (OR)|2.335|STANDARD_ERROR_OF_MEAN|2.683||0.46|TWO_SIDED|95.0|0.246|22.194|||Chi-squared|||||22.194|.246|.460
91569620|NCT04522778|183028981|SUPERIORITY||Odds Ratio (OR)|2.299|STANDARD_ERROR_OF_MEAN|2.47293||0.439|TWO_SIDED|95.0|0.279|18.927|||Chi-squared|||||18.927|.279|.439
91569621|NCT04522778|183028982|SUPERIORITY||Odds Ratio (OR)|1.634|STANDARD_ERROR_OF_MEAN|2.187||0.714|TWO_SIDED|95.0|0.119|22.514|||Chi-squared|||||22.514|.119|.714
91569622|NCT04522778|183028983|SUPERIORITY||Odds Ratio (OR)|0.379|STANDARD_ERROR_OF_MEAN|0.448||0.412|TWO_SIDED|95.0|0.037|3.842|||Chi-squared|||||3.842|.037|.412
91569623|NCT04522778|183028984|SUPERIORITY||Odds Ratio (OR)|0.579|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|0.094|3.582|||Chi-squared|||||3.582|.094|.558
91569624|NCT04522778|183028985|SUPERIORITY||Odds Ratio (OR)|0.688|STANDARD_ERROR_OF_MEAN|0.609||0.673|TWO_SIDED|95.0|0.121|3.9|||Chi-squared|||||3.90|.121|.673
91569625|NCT04522778|183028986|SUPERIORITY||Odds Ratio (OR)|0.674|STANDARD_ERROR_OF_MEAN|0.438||0.544|TWO_SIDED|95.0|0.189|2.406|||Chi-squared|||||2.406|.189|.544
91569626|NCT04522778|183028987|SUPERIORITY||Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.631||0.464|TWO_SIDED|95.0|0.345|10.278|||Chi-squared|||||10.278|.345|.464
91569627|NCT04522778|183028988|SUPERIORITY||Odds Ratio (OR)|5.595|STANDARD_ERROR_OF_MEAN|5.675||0.09|TWO_SIDED|95.0|0.766|40.854|||Chi-squared|||||40.854|.766|.090
91569628|NCT04522778|183028989|SUPERIORITY||Odds Ratio (OR)|0.987|STANDARD_ERROR_OF_MEAN|1.119||0.991|TWO_SIDED|95.0|0.107|9.114|||Chi-squared|||||9.114|.107|.991
91569629|NCT04522778|183028990|SUPERIORITY||Odds Ratio (OR)|4.239|STANDARD_ERROR_OF_MEAN|5.027||0.223|TWO_SIDED|95.0|0.415|43.326|||Chi-squared|||||43.326|.415|.223
91569630|NCT04522778|183028991|SUPERIORITY||Odds Ratio (OR)|2.199|STANDARD_ERROR_OF_MEAN|2.496||0.488|TWO_SIDED|95.0|0.238|20.348|||Chi-squared|||||20.348|.238|.488
91569631|NCT04522778|183028992|SUPERIORITY||Odds Ratio (OR)|0.177|STANDARD_ERROR_OF_MEAN|0.129||0.018|TWO_SIDED|95.0|0.0424|0.743|||Chi-squared|||||.743|.0424|.018
91569632|NCT04522778|183028993|SUPERIORITY||Odds Ratio (OR)|3.688|STANDARD_ERROR_OF_MEAN|4.358||0.269|TWO_SIDED|95.0|0.364|37.379|||Chi-squared|||||37.379|.364|.269
91569633|NCT04522778|183028994|SUPERIORITY||Odds Ratio (OR)|4.251|STANDARD_ERROR_OF_MEAN|3.829||0.108|TWO_SIDED|95.0|0.728|24.84|||Chi-squared|||||24.84|.728|.108
91569634|NCT04522778|183028995|SUPERIORITY||Odds Ratio (OR)|3.658|STANDARD_ERROR_OF_MEAN|2.99||0.113|TWO_SIDED|95.0|0.737|18.157|||Chi-squared|||||18.157|.737|.113
91569635|NCT04522778|183028996|SUPERIORITY||Odds Ratio (OR)|2.495|STANDARD_ERROR_OF_MEAN|1.156||0.049|TWO_SIDED|95.0|1.004|6.202|||Chi-squared|||||6.202|1.004|.049
91569636|NCT00953199|183029047|SUPERIORITY_OR_OTHER|||||||0.45||||||.05 was set as level of significance|Chi-squared|||We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.||||.45
91569637|NCT01024036|183029049|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0012|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0012
91569638|NCT01024036|183029049|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0004|TWO_SIDED|95.0|11.1|54.8|||Fisher Exact|Without adjusting for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0004
91569639|NCT01024036|183029051|SUPERIORITY_OR_OTHER||Difference in overall response rates|33.9||||0.0022|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|||||54.8|11.1|0.0022
91569640|NCT01024036|183029053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.0084|TWO_SIDED|95.0|0.214|0.815|||Log Rank||Hazard ratio and 95% CI from a Cox proportional hazards model|||0.815|0.214|0.0084
91569641|NCT01024036|183029054|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|61.3||||0.0002|TWO_SIDED|95.0|28.3|85.1|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||85.1|28.3|0.0002
91569642|NCT01024036|183029055|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|41.9||||0.0195|TWO_SIDED|95.0|7.8|70.7|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||70.7|7.8|0.0195
91569643|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.||||0.377
91569644|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.||||0.051
91569645|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.||||0.282
91569646|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.||||0.277
91569647|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.||||0.308
91569648|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.211
91569649|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.004
91569650|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.||||0.221
91569651|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.||||0.796
91569652|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.||||0.463
91569653|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.118
91569654|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.0001
91569655|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.||||0.0001
91569656|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.||||0.0001
91569657|NCT02672514|183029084|SUPERIORITY_OR_OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.||||0.171
91569658|NCT00942188|183029086|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.854|||||TWO_SIDED|95.0|-1.94|0.23|||ANCOVA|||||0.23|-1.94|
91569659|NCT00942188|183029086|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.252|||||TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-0.03|-2.48|
91569660|NCT00942188|183029086|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||TWO_SIDED|95.0|-1.76|0.54|||ANCOVA|||||0.54|-1.76|
91569661|NCT00942188|183029087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.995|||||TWO_SIDED|95.0|-9.82|3.83|||ANCOVA|||||3.83|-9.82|
91569662|NCT00942188|183029087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.324|||||TWO_SIDED|95.0|-10.21|5.56|||ANCOVA|||||5.56|-10.21|
91569663|NCT00942188|183029087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.635|||||TWO_SIDED|95.0|-9.16|5.89|||ANCOVA|||||5.89|-9.16|
91569664|NCT00942188|183029089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.59|0.05||This is the estimated value for week 10 HbA1c.|ANCOVA|||||0.05|-0.59|
91569665|NCT00942188|183029089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.369|||||TWO_SIDED|95.0|-0.74|0.0||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.00|-0.74|
91569666|NCT00942188|183029089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.227|||||TWO_SIDED|95.0|-0.59|0.13||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.13|-0.59|
91569667|NCT00942188|183029089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.267|||||TWO_SIDED|95.0|-0.61|0.08||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.08|-0.61|
91569668|NCT00942188|183029089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.396|||||TWO_SIDED|95.0|-0.79|0.0||This is the estimated value for HbA1c at Week 12.|ANCOVA|||||0.00|-0.79|
91569669|NCT00942188|183029089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.221|||||TWO_SIDED|95.0|-0.59|0.15||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.15|-0.59|
91569670|NCT00143598|183029100|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.58|TWO_SIDED|95.0|0.73|1.76|||Regression, Cox|Adjusted for centre||||1.76|.73|.58
91569671|NCT00730015|183029131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.72|||<|0.0001|TWO_SIDED|95.0|3.41|17.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be at least 90% based on study NCT00402337(MCP-103-201) data.||17.47|3.41|<0.0001
91569672|NCT00730015|183029131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.21|||<|0.0001|TWO_SIDED|95.0|3.14|16.59||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be greater than 96% based on study NCT00402337(MCP-103-201) data.||16.59|3.14|<0.0001
91569673|NCT02053610|183029159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.41|0.58|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.58|0.41|<0.0001
91569674|NCT02053610|183029161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.54|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|Stratified by Binet stage at Baseline.|||0.54|0.33|<0.0001
91569675|NCT02053610|183029163|SUPERIORITY_OR_OTHER||Difference in Response Rates|13.22||||0.0001|TWO_SIDED|95.0|6.3|20.1|||Chi-squared|||Includes participants with EOTR: CR, CRi, PR or nPR.||20.1|6.3|0.0001
91569676|NCT02053610|183029164|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.92||||0.0002|TWO_SIDED|95.0|6.1|19.8|||Chi-squared|||Includes participants with best overall response: CR, CRi, PR or nPR.||19.8|6.1|0.0002
91569677|NCT02053610|183029165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.43|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.43|<0.0001
91569678|NCT02053610|183029166|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.76||||0.0245|TWO_SIDED|95.0|0.6|0.97|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.97|0.60|0.0245
91569679|NCT02053610|183029167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.41|<0.0001
91569680|NCT02053610|183029169|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.73|0.46|<0.0001
91569681|NCT01165177|183029172|OTHER|Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|96.6|||<|0.0001|TWO_SIDED|95.0|89.6|99.3||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||99.3|89.6|<0.0001
91569682|NCT01165177|183029172|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.4|||<|0.0001|TWO_SIDED|95.0|90.1|99.7||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group||99.7|90.1|<0.0001
91569683|NCT01165177|183029172|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.9||||0.0001|TWO_SIDED|95.0|87.9|100.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|87.9|0.0001
91569684|NCT01165177|183029172|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.2|||<|0.0001|TWO_SIDED|95.0|93.7|99.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group||99|93.7|<0.0001
91569685|NCT01165177|183029173|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.9|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||100|40.9|0.0081
91569686|NCT01165177|183029173|OTHER|Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.8|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group||100|-442.8|0.5097
91569687|NCT01165177|183029173|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0078|TWO_SIDED|95.0|41.4|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|41.4|0.0078
91569688|NCT01165177|183029173|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0001|TWO_SIDED|95.0|77.1|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group||100|77.1|<0.0001
91569689|NCT05499130|183029194|OTHER||Difference in Response Rate|15.7||||||||||||||||||
91569690|NCT05499130|183029194|OTHER||Posterior Probability|0.949|||||||||||||A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.|||||
91569691|NCT05499130|183029194|OTHER||Difference in Response Rate|27.4||||||||||||||||||
91569692|NCT05499130|183029194|OTHER||Posterior Probability|0.997|||||||||||||A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.|||||
91569693|NCT05499130|183029195|OTHER||Difference in Response Rate|13.0||||||||||||||||||
91569694|NCT05499130|183029195|OTHER||Posterior Probability|0.939|||||||||||||A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.|||||
91569695|NCT05499130|183029195|OTHER||Difference in Response Rate|34.8||||||||||||||||||
91569696|NCT05499130|183029195|OTHER||Posterior Probability|1.0|||||||||||||A beta-binomial model was employed to obtain this posterior probability using a non-informative prior to assess superior efficacy compared to placebo.|||||
91569697|NCT00781937|183029213|SUPERIORITY_OR_OTHER||Treatment Contrast|-6.06|||<|0.0001||95.0|-7.5|-4.62||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||-4.62|-7.50|<0.0001
91569698|NCT00781937|183029214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.82|||<|0.0001||95.0|3.01|7.71||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||7.71|3.01|<0.0001
91569699|NCT00781937|183029215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.44|6.09||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||6.09|2.44|<0.0001
91569700|NCT00781937|183029216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3|||<|0.0001||95.0|2.79|10.08||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.08|2.79|<0.0001
91569701|NCT00781937|183029217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.0001||95.0|0.03|0.26||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||0.26|0.03|<0.0001
91569702|NCT00781937|183029219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.86|||<|0.0001||95.0|3.12|10.98||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.98|3.12|<0.0001
91569703|NCT00781937|183029220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.02|||<|0.0001||95.0|3.65|9.92||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||9.92|3.65|<0.0001
91569704|NCT00781937|183029221|SUPERIORITY_OR_OTHER||Treatment Contrast|-5.86|||<|0.0001||95.0|-7.3|-4.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-4.43|-7.30|<0.0001
91569705|NCT00781937|183029222|SUPERIORITY_OR_OTHER||Treatment Contrast|-4.23|||<|0.0001||95.0|-6.04|-2.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.43|-6.04|<0.0001
91569706|NCT00781937|183029223|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.72||||0.0068||95.0|-4.69|-0.76||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in systolic blood pressure.||-0.76|-4.69|0.0068
91569707|NCT00781937|183029223|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.34||||0.6386||95.0|-1.74|1.07||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in diastolic blood pressure.||1.07|-1.74|0.6386
91569708|NCT00781937|183029224|SUPERIORITY_OR_OTHER||Treatment Contrast|0.97||||0.1968||95.0|-0.51|2.45||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||2.45|-0.51|0.1968
91569709|NCT00781937|183029225|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.031||95.0|-0.2|-0.01||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.01|-0.20|0.0310
91569710|NCT00781937|183029226|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.09||||0.1098||95.0|-0.2|0.02||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.02|-0.20|0.1098
91569711|NCT00781937|183029227|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.1149||95.0|-0.24|0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.03|-0.24|0.1149
91569712|NCT00781937|183029228|SUPERIORITY_OR_OTHER||Treatment Contrast|-13.01||||0.0141||95.0|-23.4|-2.64||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.64|-23.40|0.0141
91569713|NCT00781937|183029229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.1199||95.0|0.36|1.12||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.||||1.12|0.36|0.1199
91569714|NCT00781937|183029230|SUPERIORITY_OR_OTHER||Treatment Contrast|-3.5|||<|0.0001||95.0|-4.84|-2.15||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.15|-4.84|<0.0001
91569715|NCT00781937|183029231|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.05|||<|0.0001||95.0|-2.53|-1.57||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-1.57|-2.53|<0.0001
91569716|NCT00781937|183029232|SUPERIORITY_OR_OTHER||Treatment Contrast|2.35||||0.3689||95.0|-2.79|7.49||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||7.49|-2.79|0.3689
91569717|NCT00781937|183029233|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.1||||0.0053||95.0|-0.16|-0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.03|-0.16|0.0053
91569718|NCT00781937|183029234|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.38|||<|0.0001||95.0|-0.5|-0.26||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.26|-0.50|<0.0001
91569719|NCT00781937|183029235|SUPERIORITY_OR_OTHER||Treatment Contrast|-1.85||||0.0147||95.0|-3.34|-0.37||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.37|-3.34|0.0147
91569720|NCT00781937|183029236|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.27|||<|0.0001||95.0|-0.33|-0.21||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.21|-0.33|<0.0001
91569721|NCT00013611|183029239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.47|TWO_SIDED|95.0|0.7|1.18|||Regression, Cox|Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.||Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.||1.18|0.70|0.47
91569722|NCT00013611|183029240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.77|1.44|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.44|0.77|0.73
91569723|NCT00013611|183029241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1|TWO_SIDED|95.0|0.51|1.06|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.06|0.51|0.10
91569724|NCT00013611|183029242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.35|TWO_SIDED|95.0|0.9|1.34|||Regression, Cox|||||1.34|0.90|0.35
91569725|NCT00013611|183029243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.001|TWO_SIDED|95.0|40.3|65.7|||Mixed Models Analysis|||||65.7|40.3|< 0.001
91569726|NCT01663506|183029258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 3||||<0.01
91569727|NCT01663506|183029258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
91569728|NCT01663506|183029258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
91569729|NCT01663506|183029260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
91569730|NCT01663506|183029260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
91569731|NCT01663506|183029261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
91569732|NCT01663506|183029261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
91569733|NCT01663506|183029263|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
91569734|NCT01663506|183029263|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
91569735|NCT01663506|183029264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
91569736|NCT01663506|183029266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
91569737|NCT01663506|183029266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
91569738|NCT01663506|183029267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
91569739|NCT01663506|183029267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
91569740|NCT01663506|183029269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 6||||<0.01
91569741|NCT01663506|183029269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 6||||<0.01
91569742|NCT01663506|183029269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 12||||<0.001
91569743|NCT01663506|183029269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 12||||<0.01
91569744|NCT01663506|183029270|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
91569745|NCT01663506|183029270|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
91569746|NCT01663506|183029271|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
91569747|NCT01663506|183029271|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
91569748|NCT02431052|183029278|OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0006
91569749|NCT02431052|183029279|OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0002
91569750|NCT02431052|183029280|OTHER|||||||0.0055|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).||||||0.0055
91569751|NCT03546816|183029291|SUPERIORITY|||||||0.229||||||P-value from a Cochran-Mantel-Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.229
91569752|NCT03546816|183029292|SUPERIORITY|||||||0.013||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.013
91569753|NCT03546816|183029293|SUPERIORITY|||||||0.236||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.236
91569754|NCT03546816|183029294|SUPERIORITY|||||||0.083||||||P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.083
91569755|NCT03546816|183029294|SUPERIORITY|||||||0.049||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.049
91569756|NCT03546816|183029294|SUPERIORITY|||||||0.081||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 6||||0.081
91569757|NCT03546816|183029294|SUPERIORITY|||||||0.157||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.157
91569758|NCT03546816|183029295|SUPERIORITY|||||||0.151||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.151
91569759|NCT03546816|183029295|SUPERIORITY|||||||0.052||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.052
91569760|NCT03546816|183029295|SUPERIORITY|||||||0.175||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.175
91569761|NCT03546816|183029296|SUPERIORITY|||||||0.475||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.475
91569762|NCT03546816|183029296|SUPERIORITY|||||||0.02||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.020
91569763|NCT03546816|183029296|SUPERIORITY|||||||0.492||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.492
91569764|NCT03546816|183029297|SUPERIORITY|||||||0.175||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.175
91569765|NCT03546816|183029297|SUPERIORITY|||||||0.169||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.169
91569766|NCT03546816|183029297|SUPERIORITY|||||||0.516||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.516
91569767|NCT03546816|183029298|SUPERIORITY|||||||0.814||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.814
91569768|NCT03546816|183029299|SUPERIORITY|||||||0.113||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.113
91569769|NCT01161446|183029301|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91569770|NCT01161446|183029302|NON_INFERIORITY|Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.61|1.9|||Regression, Logistic|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.90|0.61|
91569771|NCT01161446|183029303|NON_INFERIORITY|Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.|Difference in proportions|-0.068|||||TWO_SIDED|95.0|-0.16|0.016||||||||0.016|-0.16|
91569772|NCT01161446|183029304|NON_INFERIORITY|Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.|Incidence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.33|||Poisson regression|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.33|0.64|
91569773|NCT02270671|183029307|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
91569774|NCT02270671|183029308|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.026|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
91569775|NCT02270671|183029309|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
91569776|NCT02270671|183029310|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \<.0001|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
91569777|NCT02270671|183029311|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.007|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
91569778|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-2.6||||0.887|TWO_SIDED|90.0|-6.2|1.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||1.0|-6.2|0.887
91569779|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.431|TWO_SIDED|90.0|-2.6|3.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||3.2|-2.6|0.431
91569780|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-1.0||||0.647|TWO_SIDED|90.0|-5.4|3.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||3.4|-5.4|0.647
91569781|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|2.4||||0.13|TWO_SIDED|90.0|-1.1|6.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||6.0|-1.1|0.130
91569782|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-2.5||||0.818|TWO_SIDED|90.0|-6.9|2.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||2.0|-6.9|0.818
91569783|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.457|TWO_SIDED|90.0|-3.6|4.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||4.1|-3.6|0.457
91569784|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-3.1||||0.906|TWO_SIDED|90.0|-6.9|0.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||0.8|-6.9|0.906
91569785|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-0.4||||0.566|TWO_SIDED|90.0|-4.1|3.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||3.3|-4.1|0.566
91569786|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-1.3||||0.686|TWO_SIDED|90.0|-5.6|3.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||3.1|-5.6|0.686
91569787|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|1.4||||0.28|TWO_SIDED|90.0|-2.5|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||5.2|-2.5|0.280
91569788|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-2.4||||0.849|TWO_SIDED|90.0|-6.3|1.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.4|-6.3|0.849
91569789|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|1.5||||0.254|TWO_SIDED|90.0|-2.2|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||5.2|-2.2|0.254
91569790|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|-2.7||||0.866|TWO_SIDED|90.0|-6.6|1.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.3|-6.6|0.866
91569791|NCT03927690|183029332|SUPERIORITY||Difference (Test vs Reference)|2.0||||0.198|TWO_SIDED|90.0|-1.9|5.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||5.8|-1.9|0.198
91569792|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.2||||0.998|TWO_SIDED|90.0|1.08|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.33|1.08|0.998
91569793|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.0||||0.527|TWO_SIDED|90.0|0.92|1.09|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.09|0.92|0.527
91569794|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.21||||0.999|TWO_SIDED|90.0|1.1|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||1.33|1.10|0.999
91569795|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.03||||0.716|TWO_SIDED|90.0|0.95|1.12|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||1.12|0.95|0.716
91569796|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.21||||1|TWO_SIDED|90.0|1.13|1.31|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.31|1.13|1.000
91569797|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|0.98||||0.281|TWO_SIDED|90.0|0.91|1.05|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.05|0.91|0.281
91569798|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.32||||1|TWO_SIDED|90.0|1.2|1.46|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.46|1.20|1.000
91569799|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|0.96||||0.2|TWO_SIDED|90.0|0.88|1.04|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.04|0.88|0.200
91569800|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|1.18||||1|TWO_SIDED|90.0|1.09|1.28|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.28|1.09|1.000
91569801|NCT03927690|183029338|SUPERIORITY||Ratio (Test vs Reference)|0.94||||0.083|TWO_SIDED|90.0|0.87|1.01|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.01|0.87|0.083
91569802|NCT03927690|183029338|SUPERIORITY||Ratio(Test vs Reference)|1.26||||1|TWO_SIDED|90.0|1.14|1.38|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.38|1.14|1.000
91569803|NCT03927690|183029338|SUPERIORITY||Ratio(Test vs Reference)|0.96||||0.254|TWO_SIDED|90.0|0.88|1.06|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.06|0.88|0.254
91569804|NCT04182113|183029386|SUPERIORITY||Mean Difference (Net)|-0.042||||0.32|TWO_SIDED|95.0|-0.129|0.044||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing Target vs. Foil activity following 1Hz rTMS to Target vs. Foil activity following 20 Hz rTMS stimulation.||0.044|-0.129|0.32
91569805|NCT04182113|183029386|SUPERIORITY||Mean Difference (Net)|0.043||||0.25|TWO_SIDED|95.0|-0.03|0.12||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activation following 1 Hz rTMS and Target vs. Foil activation following Sham stimulation..||0.12|-0.03|0.25
91569806|NCT04182113|183029386|SUPERIORITY||Mean Difference (Net)|0.078||||0.13|TWO_SIDED|95.0|-0.024|0.181||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activity following 20 Hz rTMS and Target vs. Foil activity following Sham stimulation.||0.181|-0.024|0.13
91569807|NCT04182113|183029387|SUPERIORITY||Mean Difference (Net)|0.018||||0.038|TWO_SIDED|95.0|0.001|0.034||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.034|0.001|0.038
91569808|NCT04182113|183029387|SUPERIORITY||Mean Difference (Net)|0.009||||0.44|TWO_SIDED|95.0|-0.015|0.033|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.033|-0.015|0.44
91569809|NCT04182113|183029387|SUPERIORITY||Mean Difference (Net)|-0.012||||0.25|TWO_SIDED|95.0|-0.032|0.009|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 20Hz rTMS to precuneus connectivity following sham stimulation.||0.009|-0.032|0.25
91569810|NCT04182113|183029388|SUPERIORITY||Mean Difference (Net)|2.7||||0.2|TWO_SIDED|95.0|-1.6|6.9||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following 20 Hz rTMS.||6.9|-1.6|0.20
91569811|NCT04182113|183029388|SUPERIORITY||Mean Difference (Net)|4.0||||0.17|TWO_SIDED|95.0|-1.9|9.9||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following sham rTMS.||9.9|-1.9|0.17
91569812|NCT04182113|183029388|SUPERIORITY||Mean Difference (Net)|-1.3||||0.77|TWO_SIDED|95.0|-10.8|8.2||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 20Hz rTMS to accuracy following 20 Hz rTMS.||8.2|-10.8|0.77
91569813|NCT03539068|183029396|SUPERIORITY||||||<|1e-05|||||||Chi-squared|||||||<0.00001
91569814|NCT00551135|183029399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0668|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0668
91569815|NCT00551135|183029399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0334|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0334
91569816|NCT00551135|183029399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
91569817|NCT00551135|183029399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
91569818|NCT00551135|183029399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6932
91569819|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4471
91569820|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7248|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7248
91569821|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7556|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7556
91569822|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0571|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0571
91569823|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0197
91569824|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2398|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2398
91569825|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0709|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0709
91569826|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9902|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9902
91569827|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0018
91569828|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4639|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4639
91569829|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4845|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4845
91569830|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1641|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1641
91569831|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1025|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1025
91569832|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5615
91569833|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2904|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2904
91569834|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6017|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6017
91569835|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8549|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8549
91569836|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3386|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3386
91569837|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
91569838|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5244|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5244
91569839|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4245|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4245
91569840|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8624
91569841|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7552|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7552
91569842|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7329|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7329
91569843|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3053|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3053
91569844|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5290
91569845|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7951|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7951
91569846|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7150
91569847|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4566|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4566
91569848|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7750
91569849|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9241|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9241
91569850|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8994|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8994
91569851|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2088|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2088
91569852|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2152|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2152
91569853|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7662|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7662
91569854|NCT00551135|183029400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7579|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7579
91569855|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6896|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6896
91569856|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1934|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1934
91569857|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6034
91569858|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7992|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7992
91569859|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4770
91569860|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
91569861|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2000
91569862|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5059|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5059
91569863|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
91569864|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3815|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3815
91569865|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4716|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4716
91569866|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1063
91569867|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3884|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3884
91569868|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3787|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3787
91569869|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2537
91569870|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0952|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0952
91569871|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7725|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7725
91569872|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0660
91569873|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3657|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3657
91569874|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7717|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7717
91569875|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5849|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5849
91569876|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9580
91569877|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9884|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9884
91569878|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6743
91569879|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2689|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2689
91569880|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6907|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6907
91569881|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4798|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4798
91569882|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5609
91569883|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9834
91569884|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8339|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8339
91569885|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
91569886|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6327|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6327
91569887|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3986|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3986
91569888|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6370
91569889|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9869
91569890|NCT00551135|183029401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7550
91569891|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2912
91569892|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3723
91569893|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6116|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6116
91569894|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0835|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0835
91569895|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1497|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1497
91569896|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3950
91569897|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5892|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5892
91569898|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6143
91569899|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0104
91569900|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5666|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5666
91569901|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9008|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9008
91569902|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0967|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0967
91569903|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8353|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8353
91569904|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4530
91569905|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7297|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7297
91569906|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0692
91569907|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6333|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6333
91569908|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0325
91569909|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5788|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5788
91569910|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9224|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9224
91569911|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5527|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5527
91569912|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2624
91569913|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3263|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3263
91569914|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3746|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3746
91569915|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0050
91569916|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0493|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0493
91569917|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0773|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0773
91569918|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0547
91569919|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1976
91569920|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3832|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3832
91569921|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4216|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4216
91569922|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5852|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5852
91569923|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7336|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7336
91569924|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1647|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1647
91569925|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2813|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2813
91569926|NCT00551135|183029402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8423|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8423
91569927|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.397|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.3970
91569928|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.764|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7640
91569929|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5064|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5064
91569930|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1318|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1318
91569931|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9367
91569932|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1259|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1259
91569933|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1812|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1812
91569934|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9600
91569935|NCT00551135|183029403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1050
91569936|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2818|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2818
91569937|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8631|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8631
91569938|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5074
91569939|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0401|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0401
91569940|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5509|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5509
91569941|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0004
91569942|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
91569943|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.384|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3840
91569944|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2732|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2732
91569945|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4418|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4418
91569946|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8379
91569947|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5944|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5944
91569948|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8139|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8139
91569949|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9709|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9709
91569950|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9666|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9666
91569951|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3204|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3204
91569952|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0869|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0869
91569953|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9386|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9386
91569954|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4352|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4352
91569955|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4522|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4522
91569956|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6606|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6606
91569957|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1733|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1733
91569958|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8788|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8788
91569959|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8474|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8474
91569960|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2938|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2938
91569961|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7602
91569962|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6881|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6881
91569963|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7883|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7883
91569964|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5374|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5374
91569965|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9774|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9774
91569966|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3082
91569967|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4373|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4373
91569968|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.654|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6540
91569969|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0002
91569970|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0696
91569971|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0029
91569972|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3695|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3695
91569973|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9346|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9346
91569974|NCT00551135|183029404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9631|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9631
91569975|NCT00551135|183029405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9025|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9025
91569976|NCT00551135|183029405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5652|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5652
91569977|NCT00551135|183029405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7920
91569978|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6679|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6679
91569979|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7308|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7308
91569980|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6781|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6781
91569981|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0930
91569982|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3751|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3751
91569983|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0111|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0111
91569984|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6811|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6811
91569985|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7426|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7426
91569986|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1619|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1619
91569987|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1132|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1132
91569988|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9822|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9822
91569989|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1883|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1883
91569990|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9391|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9391
91569991|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9664|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9664
91569992|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0747|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0747
91569993|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9681|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9681
91569994|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3246|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3246
91569995|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7984|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7984
91569996|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8581|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8581
91569997|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9677|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9677
91569998|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7104
91569999|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8978|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8978
91570000|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.626|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6260
91570001|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4047
91570002|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4461
91570003|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9099|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9099
91570004|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8805|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8805
91570005|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2348|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2348
91570006|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4445|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4445
91570007|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8849|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8849
91570008|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2796|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2796
91570009|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5225|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5225
91570010|NCT00551135|183029406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7015|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7015
91570011|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3332|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3332
91570012|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0933
91570013|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0031
91570014|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9451|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9451
91570015|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7312|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7312
91570016|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
91570017|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8936|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8936
91570018|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7672|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7672
91570019|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4285|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4285
91570020|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0785|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0785
91570021|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3348|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3348
91570022|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1366|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1366
91570023|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3338|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3338
91570024|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4460
91570025|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1078|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1078
91570026|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8273|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8273
91570027|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6140
91570028|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1684|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1684
91570029|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
91570030|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2640
91570031|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8956
91570032|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0058
91570033|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9929|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9929
91570034|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0473|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0473
91570035|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2426|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2426
91570036|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3478|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3478
91570037|NCT00551135|183029410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1694|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1694
91570038|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0630
91570039|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
91570040|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0024
91570041|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0767|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0767
91570042|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1327|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1327
91570043|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0078
91570044|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0694
91570045|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2173|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2173
91570046|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0193
91570047|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0673|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0673
91570048|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2629|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2629
91570049|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0388|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0388
91570050|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0651|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0651
91570051|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3242|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3242
91570052|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0345|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0345
91570053|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0487|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0487
91570054|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3384
91570055|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0467|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0467
91570056|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
91570057|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3086|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3086
91570058|NCT00551135|183029411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0406|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0406
91570059|NCT00551135|183029412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4177|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4177
91570060|NCT00551135|183029412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4410
91570061|NCT00551135|183029412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.556|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5560
91570062|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
91570063|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
91570064|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
91570065|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5272|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5272
91570066|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4257|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4257
91570067|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1428|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1428
91570068|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2316|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2316
91570069|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3468|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3468
91570070|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5367|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5367
91570071|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0549|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0549
91570072|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1351
91570073|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9599|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9599
91570074|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
91570075|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
91570076|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
91570077|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2869|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2869
91570078|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9905
91570079|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9381|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9381
91570080|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2158|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2158
91570081|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7887|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7887
91570082|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.925|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9250
91570083|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1472|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1472
91570084|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5383|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5383
91570085|NCT00551135|183029413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8869|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8869
91570086|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.4024
91570087|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9766|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9766
91570088|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9975|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9975
91570089|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9038|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9038
91570090|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9370
91570091|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2134|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.2134
91570092|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2482
91570093|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2207
91570094|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.9191
91570095|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0686
91570096|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0746
91570097|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0512|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0512
91570098|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7118|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.7118
91570099|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9883|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9883
91570100|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9770
91570101|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5457|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.5457
91570102|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2579|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.2579
91570103|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.1232
91570104|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.2880
91570105|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0894|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.0894
91570106|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1979|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.1979
91570107|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0686
91570108|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0746
91570109|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4669|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.4669
91570110|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.5533
91570111|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
91570112|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
91570113|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.4793
91570114|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.3533
91570115|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8852|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.8852
91570116|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
91570117|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
91570118|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8864|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.8864
91570119|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8084|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.8084
91570120|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.3173
91570121|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.2207
91570122|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.3747
91570123|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.1450
91570124|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2054|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.2054
91570125|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4106|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.4106
91570126|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2199
91570127|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2896|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2896
91570128|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||1.0000
91570129|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3173
91570130|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3943
91570131|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1703|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.1703
91570132|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0807|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.0807
91570133|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7728|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.7728
91570134|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.4770
91570135|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3625|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.3625
91570136|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0617|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.0617
91570137|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3061|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 72 h PS;||||0.3061
91570138|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.2207
91570139|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.3173
91570140|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.9191
91570141|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.3173
91570142|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.2207
91570143|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6692|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6692
91570144|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.7793
91570145|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6065|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6065
91570146|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.357|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.3570
91570147|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.9690
91570148|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5299|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.5299
91570149|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4821|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.4821
91570150|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.8295
91570151|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3304|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.3304
91570152|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 3 h PS;||||0.2482
91570153|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2482
91570154|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2207
91570155|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8055|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.8055
91570156|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.9191
91570157|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8488|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.8488
91570158|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.2482
91570159|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
91570160|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2207
91570161|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
91570162|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.3291
91570163|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.1391
91570164|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6318|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.6318
91570165|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6319|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.6319
91570166|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8149|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.8149
91570167|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5795|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.5795
91570168|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.1750
91570169|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0676|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.0676
91570170|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.2943
91570171|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0719|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.0719
91570172|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9283|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9283
91570173|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9024
91570174|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7655|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.7655
91570175|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||1.0000
91570176|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.846|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.8460
91570177|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6419|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.6419
91570178|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9522|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.9522
91570179|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.5800
91570180|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7675|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.7675
91570181|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1672|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1672
91570182|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9634|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.9634
91570183|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1161|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1161
91570184|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0754|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0754
91570185|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
91570186|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
91570187|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
91570188|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8091|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.8091
91570189|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
91570190|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
91570191|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
91570192|NCT00551135|183029414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4386|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.4386
91570193|NCT00551135|183029415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1723
91570194|NCT00551135|183029415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0639|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS||||0.0639
91570195|NCT00551135|183029415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.0021
91570196|NCT00551135|183029415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1127|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.1127
91570197|NCT00551135|183029415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0703
91570198|NCT00551135|183029415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0012
91570199|NCT00551135|183029417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1927|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1927
91570200|NCT00551135|183029417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3865|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS||||0.3865
91570201|NCT00551135|183029417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.9869
91570202|NCT00551135|183029417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4354|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.4354
91570203|NCT00551135|183029417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.8061
91570204|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1682|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1682
91570205|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2821|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2821
91570206|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4781|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4781
91570207|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0557|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0557
91570208|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6098
91570209|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1821|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1821
91570210|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1628|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1628
91570211|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8999
91570212|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
91570213|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2665|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2665
91570214|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4885|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4885
91570215|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6415|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6415
91570216|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2269|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2269
91570217|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3228
91570218|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1808
91570219|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3282|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3282
91570220|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0342
91570221|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4198|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4198
91570222|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9049
91570223|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0456
91570224|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2463|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2463
91570225|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8231|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8231
91570226|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0221|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0221
91570227|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6974|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6974
91570228|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7461
91570229|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1198|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1198
91570230|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8031|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8031
91570231|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8515|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8515
91570232|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
91570233|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5561|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5561
91570234|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6858|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6858
91570235|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0693|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0693
91570236|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5547|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5547
91570237|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4610
91570238|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.664|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6640
91570239|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6158|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6158
91570240|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1632
91570241|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1770
91570242|NCT00551135|183029418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4882
91570243|NCT00551135|183029419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7936|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7936
91570244|NCT00551135|183029419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5092|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5092
91570245|NCT00551135|183029419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4233|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4233
91570246|NCT00551135|183029419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2033
91570247|NCT00551135|183029419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2142|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2142
91570248|NCT00551135|183029419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1218|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1218
91570249|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0830
91570250|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2339|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2339
91570251|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0629
91570252|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5721|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5721
91570253|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9713|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9713
91570254|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4809|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4809
91570255|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1561|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1561
91570256|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5267|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5267
91570257|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1125|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1125
91570258|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2965|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2965
91570259|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7774
91570260|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
91570261|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4465|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4465
91570262|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4385|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4385
91570263|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2265|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2265
91570264|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5985|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5985
91570265|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2146|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2146
91570266|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3382|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3382
91570267|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0430
91570268|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1128|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1128
91570269|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0632|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0632
91570270|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8667|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8667
91570271|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6365|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6365
91570272|NCT00551135|183029420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9275|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9275
91570273|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2136
91570274|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0094
91570275|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2131|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2131
91570276|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3245
91570277|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.4070
91570278|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3490
91570279|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1122|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1122
91570280|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1380
91570281|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2023|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2023
91570282|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2639|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2639
91570283|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2524|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2524
91570284|NCT00551135|183029422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0832|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0832
91570285|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2371|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.2371
91570286|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4435|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.4435
91570287|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1692|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.1692
91570288|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8169|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.8169
91570289|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.5592
91570290|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4453|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.4453
91570291|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4795|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.4795
91570292|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2733|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.2733
91570293|NCT00551135|183029423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.3173
91570294|NCT04599855|183029426|SUPERIORITY||least square (LS) means difference|-5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|95.0|-7.91|-2.33|||Mixed model for repeated measures|||||-2.33|-7.91|<0.001
91570295|NCT04599855|183029426|SUPERIORITY||LS means difference|-6.8|STANDARD_ERROR_OF_MEAN|1.38|<|0.001|TWO_SIDED|95.0|-9.48|-4.07|||Mixed model for repeated measures|||||-4.07|-9.48|<0.001
91570296|NCT04599855|183029427|SUPERIORITY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.29|=|0.004|TWO_SIDED|95.0|-6.29|-1.22|||Mixed model for repeated measures|||||-1.22|-6.29|=0.004
91570297|NCT04599855|183029427|SUPERIORITY||LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.24|=|0.006|TWO_SIDED|95.0|-5.89|-1.0|||Mixed model for repeated measures|||||-1.00|-5.89|=0.006
91570298|NCT04294667|183029428|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|14.6||||0.011|TWO_SIDED|95.0|3.3|25.8|||Cochran-Mantel-Haenszel|||||25.8|3.3|0.0110
91570299|NCT04294667|183029429|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.9||||0.1776|TWO_SIDED|95.0|-3.6|19.4|||Cochran-Mantel-Haenszel|||||19.4|-3.6|0.1776
91570300|NCT04294667|183029430|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|10.8||||0.0518|TWO_SIDED|95.0|-0.1|21.7|||Cochran-Mantel-Haenszel|||||21.7|-0.1|0.0518
91570301|NCT04294667|183029431|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|11.5||||0.0257|TWO_SIDED|95.0|1.4|21.6|||Cochran-Mantel-Haenszel|||||21.6|1.4|0.0257
91570302|NCT04294667|183029432|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.2||||0.1042|TWO_SIDED|95.0|-1.5|16.0|||Cochran-Mantel-Haenszel|||||16.0|-1.5|0.1042
91570303|NCT04294667|183029433|SUPERIORITY||Difference of Change(DZP+SOC vs PBO+SOC)|-1.8||||0.0001|TWO_SIDED|95.0|-2.7|-0.9|||MMRM|The Least Squares (LS) Mean, the difference (DZP+SOC versus PBO+SOC), and the 95% CIs was computed from the MMRM.||||-0.9|-2.7|0.0001
91570304|NCT04294667|183029438|SUPERIORITY|||||||0.0111|||||||Log Rank|||||||0.0111
91570305|NCT04294667|183029439|SUPERIORITY|||||||0.0228|||||||Log Rank|||||||0.0228
91570306|NCT02312206|183029505|SUPERIORITY||Hazard Ratio (HR)|0.826||||0.3028|TWO_SIDED|95.0|0.5735|1.1889|||Log Rank|||||1.1889|0.5735|0.3028
91570307|NCT01006616|183029508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031||||0.325|TWO_SIDED|95.0|-0.03|0.091|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and inhaled corticosteroid (ICS) use (yes/no)||||0.091|-0.030|0.325
91570308|NCT01006616|183029508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.029||||0.37|TWO_SIDED|95.0|-0.091|0.034|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.034|-0.091|0.370
91570309|NCT01006616|183029508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.037|TWO_SIDED|95.0|0.004|0.131|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.131|0.004|0.037
91570310|NCT01006616|183029509|SUPERIORITY_OR_OTHER||Difference in percentages|2.6||||0.096|TWO_SIDED|95.0|-0.6|6.9|||Miettinen and Nurminen||Analysis of Week 26 data|||6.9|-0.6|0.096
91570311|NCT01006616|183029509|SUPERIORITY_OR_OTHER||Difference in percentages|12.2|||<|0.001|TWO_SIDED|95.0|7.4|18.4|||Miettinen and Nurminen||Analysis of Week 26 data|||18.4|7.4|<0.001
91570312|NCT01006616|183029509|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|TWO_SIDED|95.0|13.8|26.9|||Miettinen and Nurminen||Analysis of Week 26 data|||26.9|13.8|<0.001
91570313|NCT03672175|183029540|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6638|TWO_SIDED|95.0|-2.0|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Mixed effect model for repeated measures (MMRM)||1.3|-2.0|0.6638
91570314|NCT03672175|183029540|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1158|TWO_SIDED|95.0|-3.1|0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||||0.3|-3.1|0.1158
91570315|NCT03672175|183029541|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6905|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.2|-0.4|0.6905
91570316|NCT03672175|183029541|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1082|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.1|-0.5|0.1082
91570317|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.65||0.5725|TWO_SIDED|95.0|-1.7|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||0.9|-1.7|0.5725
91570318|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|-2.8|-0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||-0.3|-2.8|0.0160
91570319|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.75||0.445|TWO_SIDED|95.0|-2.1|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||0.9|-2.1|0.4450
91570320|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0081|TWO_SIDED|95.0|-3.6|-0.5||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||-0.5|-3.6|0.0081
91570321|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8219|TWO_SIDED|95.0|-1.6|2.1||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||2.1|-1.6|0.8219
91570322|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.92||0.8166|TWO_SIDED|95.0|-2.0|1.6||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||1.6|-2.0|0.8166
91570323|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9|TWO_SIDED|95.0|-2.3|2.0||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||2.0|-2.3|0.9000
91570324|NCT03672175|183029542|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.03||0.5004|TWO_SIDED|95.0|-2.7|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||1.3|-2.7|0.5004
91570325|NCT03672175|183029543|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8903|TWO_SIDED|95.0|0.65|1.63||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15: Generalized estimating equation (GEE)||1.63|0.65|0.8903
91570326|NCT03672175|183029543|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1207|TWO_SIDED|95.0|0.91|2.25||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.25|0.91|0.1207
91570327|NCT03672175|183029543|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7897|TWO_SIDED|95.0|0.67|1.7||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.70|0.67|0.7897
91570328|NCT03672175|183029543|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6837|TWO_SIDED|95.0|0.69|1.76||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.76|0.69|0.6837
91570329|NCT03672175|183029543|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6602|TWO_SIDED|95.0|0.51|1.53||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.53|0.51|0.6602
91570330|NCT03672175|183029543|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9268|TWO_SIDED|95.0|0.56|1.69||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.69|0.56|0.9268
91570331|NCT03672175|183029544|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8245|TWO_SIDED|95.0|0.62|1.83||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.83|0.62|0.8245
91570332|NCT03672175|183029544|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0756|TWO_SIDED|95.0|0.95|2.67||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.67|0.95|0.0756
91570333|NCT03672175|183029544|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5309|TWO_SIDED|95.0|0.7|2.01||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||2.01|0.70|0.5309
91570334|NCT03672175|183029544|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9085|TWO_SIDED|95.0|0.56|1.66||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.66|0.56|0.9085
91570335|NCT03672175|183029544|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3476|TWO_SIDED|95.0|0.73|2.44||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.44|0.73|0.3476
91570336|NCT03672175|183029544|SUPERIORITY||Odds Ratio (OR)|1.45||||0.206|TWO_SIDED|95.0|0.82|2.57||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.57|0.82|0.2060
91570337|NCT03672175|183029545|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8303|TWO_SIDED|95.0|0.67|1.65||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||1.65|0.67|0.8303
91570338|NCT03672175|183029545|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1199|TWO_SIDED|95.0|0.91|2.24||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||2.24|0.91|0.1199
91570339|NCT03672175|183029546|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.71||0.5021|TWO_SIDED|95.0|-1.9|0.9||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.9|-1.9|0.5021
91570340|NCT03672175|183029546|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.2868|TWO_SIDED|95.0|-2.1|0.6||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.6|-2.1|0.2868
91570341|NCT03672175|183029547|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.35||0.5987|TWO_SIDED|95.0|-3.4|1.9||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||1.9|-3.4|0.5987
91570342|NCT03672175|183029547|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.36||0.1443|TWO_SIDED|95.0|-4.7|0.7||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.7|-4.7|0.1443
91570343|NCT03672175|183029548|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.87||0.8499|TWO_SIDED|95.0|-3.3|4.0||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.0|-3.3|0.8499
91570344|NCT03672175|183029548|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.88||0.6265|TWO_SIDED|95.0|-4.6|2.8||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.8|-4.6|0.6265
91570345|NCT03672175|183029548|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.97||0.7418|TWO_SIDED|95.0|-3.2|4.5||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.5|-3.2|0.7418
91570346|NCT03672175|183029548|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.94||0.7837|TWO_SIDED|95.0|-4.3|3.3||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.3|-4.3|0.7837
91570347|NCT03672175|183029549|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.74||0.6848|TWO_SIDED|95.0|-4.1|2.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.7|-4.1|0.6848
91570348|NCT03672175|183029549|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.11|TWO_SIDED|95.0|-6.1|0.6||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.6|-6.1|0.1100
91570349|NCT03672175|183029549|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.86||0.509|TWO_SIDED|95.0|-2.4|4.9||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.9|-2.4|0.5090
91570350|NCT03672175|183029549|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.77||0.8948|TWO_SIDED|95.0|-3.2|3.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.7|-3.2|0.8948
91570351|NCT03672175|183029550|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.25||0.9591|TWO_SIDED|95.0|-4.5|4.3||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.3|-4.5|0.9591
91570352|NCT03672175|183029550|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.28||0.2713|TWO_SIDED|95.0|-7.0|2.0||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.0|-7.0|0.2713
91570353|NCT03672175|183029550|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.43||0.8048|TWO_SIDED|95.0|-4.2|5.4||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||5.4|-4.2|0.8048
91570354|NCT03672175|183029550|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.35||0.7665|TWO_SIDED|95.0|-5.3|3.9||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.9|-5.3|0.7665
91570355|NCT03672175|183029551|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.91||0.8575|TWO_SIDED|95.0|-3.4|4.1||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.1|-3.4|0.8575
91570356|NCT03672175|183029551|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.94||0.1978|TWO_SIDED|95.0|-6.3|1.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||1.3|-6.3|0.1978
91570357|NCT03672175|183029551|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.08||0.9298|TWO_SIDED|95.0|-3.9|4.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.3|-3.9|0.9298
91570358|NCT03672175|183029551|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.03||0.5487|TWO_SIDED|95.0|-5.2|2.8||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.8|-5.2|0.5487
91570359|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.627|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.3|-0.2|0.6270
91570360|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5463|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.2|-0.4|0.5463
91570361|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.8716|TWO_SIDED|95.0|-0.3|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.3|-0.3|0.8716
91570362|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4383|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.2|-0.4|0.4383
91570363|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4794|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.3|-0.1|0.4794
91570364|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9717|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.2|-0.2|0.9717
91570365|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3701|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3701
91570366|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3972|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3972
91570367|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.5761|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.5761
91570368|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.4379|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.4379
91570369|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.6087|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.6087
91570370|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9791|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.9791
91570371|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2093|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.2093
91570372|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5189|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.5189
91570373|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6617|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.2|-0.2|0.6617
91570374|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2632|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.3|-0.1|0.2632
91570375|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.274|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.1|-0.3|0.2740
91570376|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1185|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.0|-0.3|0.1185
91570377|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.945|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.2|-0.2|0.9450
91570378|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6343|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.1|-0.2|0.6343
91570379|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3169|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.1|-0.3|0.3169
91570380|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.0178|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.0|-0.4|0.0178
91570381|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8504|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.2|-0.2|0.8504
91570382|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5647|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.1|-0.2|0.5647
91570383|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5914|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.3|0.5914
91570384|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4603|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.4|0.4603
91570385|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5637|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.5637
91570386|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4638|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.4638
91570387|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1846|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|0.0|0.1846
91570388|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4837|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|-0.1|0.4837
91570389|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1178|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.2|0.0|0.1178
91570390|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7888|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.1|-0.1|0.7888
91570391|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9496|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.1|-0.1|0.9496
91570392|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0497|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.0|-0.3|0.0497
91570393|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4189|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.1|-0.2|0.4189
91570394|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1342|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.0|-0.3|0.1342
91570395|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9202|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.2|-0.3|0.9202
91570396|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.026|TWO_SIDED|95.0|-0.5|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.0|-0.5|0.0260
91570397|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.937|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.9370
91570398|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.844|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.8440
91570399|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.448|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.3|-0.1|0.4480
91570400|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6345|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.2|-0.1|0.6345
91570401|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4123|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.3|-0.1|0.4123
91570402|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7523|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.2|-0.2|0.7523
91570403|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6505|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6505
91570404|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3674|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.3|0.3674
91570405|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.836|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.2|-0.2|0.8360
91570406|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.687|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6870
91570407|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1364|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1364
91570408|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1578|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1578
91570409|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9062|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.9062
91570410|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.8596|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.8596
91570411|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9488|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.2|-0.2|0.9488
91570412|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1514|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.0|-0.3|0.1514
91570413|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.5796|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.2|0.5796
91570414|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4739|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.3|0.4739
91570415|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9439|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.1|0.9439
91570416|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3891|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.2|0.3891
91570417|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0308
91570418|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0620
91570419|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.7744|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.1|-0.2|0.7744
91570420|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9312|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.2|-0.1|0.9312
91570421|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3105|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.1|-0.2|0.3105
91570422|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8406|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.2|-0.1|0.8406
91570423|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.4834|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.4834
91570424|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.0961|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.0961
91570425|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.829|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.8290
91570426|NCT03672175|183029552|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9546|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.9546
91570427|NCT03672175|183029553|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.78||0.1308|TWO_SIDED|95.0|-2.7|0.4||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.4|-2.7|0.1308
91570428|NCT03672175|183029553|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.77||0.0096|TWO_SIDED|95.0|-3.5|-0.5||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||-0.5|-3.5|0.0096
91570429|NCT03672175|183029553|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.2674|TWO_SIDED|95.0|-0.7|2.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.7|-0.7|0.2674
91570430|NCT03672175|183029553|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9771|TWO_SIDED|95.0|-1.7|1.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||1.7|-1.7|0.9771
91570431|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|4.42||0.611|TWO_SIDED|95.0|-10.9|6.4||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||6.4|-10.9|0.6110
91570432|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|4.19||0.0581|TWO_SIDED|95.0|-16.2|0.3||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||0.3|-16.2|0.0581
91570433|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|5.68||0.4493|TWO_SIDED|95.0|-15.5|6.9||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||6.9|-15.5|0.4493
91570434|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|6.25||0.5587|TWO_SIDED|95.0|-16.0|8.6||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||8.6|-16.0|0.5587
91570435|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.06||0.5976|TWO_SIDED|95.0|-10.1|5.8||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||5.8|-10.1|0.5976
91570436|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.05||0.9421|TWO_SIDED|95.0|-9.6|10.3||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||10.3|-9.6|0.9421
91570437|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.86||0.5581|TWO_SIDED|95.0|-6.7|12.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||12.4|-6.7|0.5581
91570438|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|5.82||0.4997|TWO_SIDED|95.0|-7.5|15.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||15.4|-7.5|0.4997
91570439|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|24.0|STANDARD_ERROR_OF_MEAN|10.5||0.0224|TWO_SIDED|95.0|3.4|44.7||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||44.7|3.4|0.0224
91570440|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|17.4|STANDARD_ERROR_OF_MEAN|10.93||0.1117|TWO_SIDED|95.0|-4.1|38.9||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||38.9|-4.1|0.1117
91570441|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|14.1|STANDARD_ERROR_OF_MEAN|14.18||0.3208|TWO_SIDED|95.0|-13.8|42.0||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||42.0|-13.8|0.3208
91570442|NCT03672175|183029554|SUPERIORITY||LS Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|13.4||0.444|TWO_SIDED|95.0|-16.1|36.6||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||36.6|-16.1|0.4440
91570443|NCT03672175|183029555|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4737|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.1|-0.3|0.4737
91570444|NCT03672175|183029555|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0138|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.0|-0.4|0.0138
91570445|NCT03672175|183029555|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1098|TWO_SIDED|95.0|0.0|0.4||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.4|0.0|0.1098
91570446|NCT03672175|183029555|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6234|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.3|-0.2|0.6234
91570447|NCT03672175|183029556|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6741|TWO_SIDED|95.0|0.52|1.53||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.53|0.52|0.6741
91570448|NCT03672175|183029556|SUPERIORITY||Odds Ratio (OR)|0.79||||0.3924|TWO_SIDED|95.0|0.46|1.36||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.36|0.46|0.3924
91570449|NCT03672175|183029556|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7307|TWO_SIDED|95.0|0.51|1.6||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.60|0.51|0.7307
91570450|NCT03672175|183029556|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8358|TWO_SIDED|95.0|0.52|1.7||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.70|0.52|0.8358
91570451|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.72||0.7375|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.2|-1.6|0.7375
91570452|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.74||0.5144|TWO_SIDED|95.0|-1.9|1.0||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.0|-1.9|0.5144
91570453|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.8343|TWO_SIDED|95.0|-1.7|1.4||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||1.4|-1.7|0.8343
91570454|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4569|TWO_SIDED|95.0|-1.0|2.3||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||2.3|-1.0|0.4569
91570455|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.63||0.4663|TWO_SIDED|95.0|-2.0|4.4||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||4.4|-2.0|0.4663
91570456|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.68||0.1138|TWO_SIDED|95.0|-0.6|6.0||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||6.0|-0.6|0.1138
91570457|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.74||0.7901|TWO_SIDED|95.0|-3.0|3.9||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||3.9|-3.0|0.7901
91570458|NCT03672175|183029557|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.71||0.3955|TWO_SIDED|95.0|-1.9|4.8||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||4.8|-1.9|0.3955
91570459|NCT03672175|183029558|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.8821|TWO_SIDED|95.0|-1.8|1.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||1.5|-1.8|0.8821
91570460|NCT03672175|183029558|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.83||0.151|TWO_SIDED|95.0|-2.8|0.4||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||0.4|-2.8|0.1510
91570461|NCT03672175|183029558|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.84||0.2926|TWO_SIDED|95.0|-0.8|2.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||2.5|-0.8|0.2926
91570462|NCT03672175|183029558|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83||0.4785|TWO_SIDED|95.0|-2.2|1.0||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||1.0|-2.2|0.4785
91570463|NCT00736125|183029580|EQUIVALENCE|nonparametric data were analyzed using Mann Whitney U Tests|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91570464|NCT00736125|183029581|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
91570465|NCT03124550|183029582|OTHER|||||||0.0008|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly average steps over the 6-week intervention.||||.0008
91570466|NCT03124550|183029583|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.01
91570467|NCT03124550|183029584|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.94
91570468|NCT03124550|183029585|OTHER|||||||0.0007|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly number of social contact over the 6-week intervention.||||.0007
91570469|NCT00014222|183029618|SUPERIORITY|||||||0.0007|||||||Log Rank|||||||0.0007
91570470|NCT00014222|183029619|SUPERIORITY|||||||0.084|||||||Log Rank|||||||0.084
91570471|NCT03269695|183029643|SUPERIORITY||Treatment difference|1.8||||1|TWO_SIDED|95.0|-41.0|47.2|||Chan and Zhang (1999)|||||47.2|-41.0|1.0000
91570472|NCT03269695|183029644|SUPERIORITY||Treatment difference|0.0||||1|TWO_SIDED|95.0|-37.0|37.0|||Chan and Zhang (1999)|||||37.0|-37.0|1.0000
91570473|NCT03269695|183029645|SUPERIORITY||Treatment difference|14.3||||0.47|TWO_SIDED|95.0|-23.8|57.9|||Chan and Zhang (1999)|||||57.9|-23.8|0.4700
91570474|NCT03269695|183029646|SUPERIORITY||Treatment difference|10.0||||0.5221|TWO_SIDED|95.0|-20.7|45.6|||Chan and Zhang (1999)|||||45.6|-20.7|0.5221
91570475|NCT03269695|183029647|SUPERIORITY||Treatment difference|32.1||||0.3166|TWO_SIDED|95.0|-23.7|74.1|||Chan and Zhang (1999)|||||74.1|-23.7|0.3166
91570476|NCT03269695|183029648|SUPERIORITY||Treatment difference|20.0||||0.5234|TWO_SIDED|95.0|-22.9|58.5|||Chan and Zhang (1999)|||||58.5|-22.9|0.5234
91570477|NCT03269695|183029649|SUPERIORITY||Treatment difference|-25.0||||0.7393|TWO_SIDED|95.0|-69.6|29.1|||Chan and Zhang (1999)|||||29.1|-69.6|0.7393
91570478|NCT03269695|183029650|SUPERIORITY||Least squares mean difference|5.8||||0.2705|TWO_SIDED|95.0|-5.08|16.67|||ANCOVA|||||16.67|-5.08|0.2705
91570479|NCT03269695|183029651|SUPERIORITY||Treatment difference|48.2||||0.0732|TWO_SIDED|95.0|-4.4|84.7|||Chan and Zhang (1999)|||||84.7|-4.4|0.0732
91570480|NCT03269695|183029652|SUPERIORITY||Treatment difference|30.0||||0.2633|TWO_SIDED|95.0|-18.4|69.2|||Chan and Zhang (1999)|||||69.2|-18.4|0.2633
91570481|NCT03269695|183029653|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.15|6.54|||Generalized Linear Mixed Model|||At Week 2||6.54|0.15|1.0000
91570482|NCT03269695|183029653|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6691|TWO_SIDED|95.0|0.23|10.0|||Generalized Linear Mixed Model|||At Week 4||10.00|0.23|0.6691
91570483|NCT03269695|183029653|SUPERIORITY||Odds Ratio (OR)|0.62||||0.6248|TWO_SIDED|95.0|0.09|4.4|||Generalized Linear Mixed Model|||At Week 8||4.40|0.09|0.6248
91570484|NCT03269695|183029653|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9965|TWO_SIDED|95.0|0.12|8.3|||Generalized Linear Mixed Model|||At Week 12||8.30|0.12|0.9965
91570485|NCT01313624|183029661|SUPERIORITY_OR_OTHER||Difference in least squares mean|0.8||||0.68|TWO_SIDED|95.0|-3.1|4.7||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||4.7|-3.1|0.68
91570486|NCT01313624|183029662|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.3||||0.56|TWO_SIDED|95.0|-3.0|5.6||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.6|-3.0|0.56
91570487|NCT00239681|183029665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.46|0.69|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.69|0.46|<0.0001
91570488|NCT00239681|183029666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.021||95.0|0.67|0.97|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.97|0.67|<0.021
91570489|NCT00239681|183029667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.172||95.0|0.65|1.08|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.08|0.65|<0.172
91570490|NCT00239681|183029668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27|||<|0.015||95.0|1.05|1.53|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.53|1.05|<0.015
91570491|NCT00239681|183029669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.018||95.0|0.35|0.91|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.91|0.35|0.018
91570492|NCT00239681|183029670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.548||95.0|0.88|1.28|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.28|0.88|0.548
91570493|NCT00905359|183029676|NON_INFERIORITY_OR_EQUIVALENCE|t-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if \<0.025 or the upper limit of the CI is less than 10%.||||||0.172|||||||t-test, 1 sided|||||||0.172
91570494|NCT02654132|183029691|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0043|TWO_SIDED|95.0|0.32|0.82|||Log Rank|||||0.82|0.32|0.0043
91570495|NCT02654132|183029692|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0002|TWO_SIDED|95.0|2.05|10.43|||Cochran-Mantel-Haenszel|||||10.43|2.05|0.0002
91570496|NCT02654132|183029693|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0217|TWO_SIDED|95.0|0.37|0.93|||Log Rank|||||0.93|0.37|0.0217
91570497|NCT00623363|183029694|SUPERIORITY|||||||0.503|||||||Monte Carlo estimates|||Baseline (Day -7)||||0.503
91570498|NCT00623363|183029694|SUPERIORITY||Least Squares (LS) Mean|20.6|||||TWO_SIDED|95.0|1.82|39.37||||||Average of Days 1 and 2||39.37|1.82|
91570499|NCT00623363|183029694|SUPERIORITY||Least Squares (LS) Mean|3.6|||||TWO_SIDED|95.0|-15.18|22.37||||||Change from Baseline||22.37|-15.18|
91570500|NCT00623363|183029694|SUPERIORITY||Least Squares (LS) Mean|36.59|||||TWO_SIDED|95.0|24.04|49.14||||||Average of Days 1 and 2||49.14|24.04|
91570501|NCT00623363|183029694|SUPERIORITY||Least Squares (LS) Mean|19.59||||0.16|TWO_SIDED|95.0|7.04|32.14|||ANCOVA|||Change from Baseline||32.14|7.04|0.160
91570502|NCT04706793|183029710|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
91570503|NCT04706793|183029711|OTHER||Risk Difference (RD)|28.57|||||TWO_SIDED|95.0|6.28|50.86||||||||50.86|6.28|
91570504|NCT04706793|183029712|OTHER||Risk Difference (RD)|32.14|||||TWO_SIDED|95.0|9.58|54.71||||||||54.71|9.58|
91570505|NCT04706793|183029713|OTHER||Risk Difference (RD)|21.43|||||TWO_SIDED|95.0|-0.07|42.92||||||||42.92|-0.07|
91570506|NCT04706793|183029714|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
91570507|NCT04706793|183029715|OTHER||Risk Difference (RD)|7.14|||||TWO_SIDED|95.0|-2.4|16.68||||||||16.68|-2.40|
91570508|NCT03713320|183029716|SUPERIORITY|||||||0.9539|||||||Cochran-Mantel-Haenszel|||Comparison of the treatment groups is based on a Cochran-Mantel-Haenzel test controlling for the number of tumors at screening (at least one tumor at screening versus no tumors at screening) and number of prognostic factors (0-1 versus 2 prognostic factors). Prognostic factors include age at diagnosis \> 60 years and lactate dehydrogenase level \> upper limit of normal at diagnosis. Number of subjects achieving ORR4 and exact binomial (Clopper-Pearson) confidence intervals are presented.||||.9539
91570509|NCT03713320|183029717|SUPERIORITY|||||||0.011|||||||Regression, Cox|||Hazard ratio (cobomarsen/vorinostat) and p-value comparing the treatment groups is based on a Cox proportional hazards model. A hazard ratio \< 1 favors cobomarsen over vorinostat.||||0.011
91570510|NCT02725528|183029731|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570511|NCT02725528|183029732|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570512|NCT02725528|183029733|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570513|NCT02725528|183029734|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570514|NCT02725528|183029735|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570515|NCT02725528|183029736|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570516|NCT02725528|183029737|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570517|NCT02725528|183029738|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570518|NCT02725528|183029739|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
91570519|NCT02706847|183029775|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||46.2|26.2|<0.001
91570520|NCT02706847|183029775|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|17.8|38.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.1|17.8|<0.001
91570521|NCT02706847|183029776|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|19.9|38.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.3|19.9|<0.001
91570522|NCT02706847|183029776|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.0|37.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||37.4|19.0|<0.001
91570523|NCT02706847|183029777|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.57|-1.01||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.01|-1.57|<0.001
91570524|NCT02706847|183029777|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.28|||<|0.001|TWO_SIDED|95.0|-1.56|-0.99||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.99|-1.56|<0.001
91570525|NCT02706847|183029778|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.34|-0.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.10|-0.34|<0.001
91570526|NCT02706847|183029778|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.13||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.13|-0.38|<0.001
91570527|NCT02706847|183029779|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean DIfference|3.44|||<|0.001|TWO_SIDED|95.0|1.72|5.15||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|1.72|<0.001
91570528|NCT02706847|183029779|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.63|||<|0.001|TWO_SIDED|95.0|2.89|6.36||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.36|2.89|<0.001
91570529|NCT02706847|183029780|SUPERIORITY||Response Rate Difference|22.3|||<|0.001|TWO_SIDED|95.0|13.6|31.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||31.1|13.6|<0.001
91570530|NCT02706847|183029780|SUPERIORITY||Response Rate Difference|23.9|||<|0.001|TWO_SIDED|95.0|15.1|32.7||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||32.7|15.1|<0.001
91570531|NCT02706847|183029781|SUPERIORITY||Response Rate Difference|5.1||||0.11|TWO_SIDED|95.0|-1.1|11.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||11.2|-1.1|0.110
91570532|NCT02706847|183029781|SUPERIORITY||Response Rate Difference|16.5|||<|0.001|TWO_SIDED|95.0|9.1|23.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||23.9|9.1|<0.001
91570533|NCT02706847|183029782|SUPERIORITY||Response Rate Difference|16.8|||<|0.001|TWO_SIDED|95.0|8.5|25.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||25.1|8.5|<0.001
91570534|NCT02706847|183029782|SUPERIORITY||Response Rate Difference|14.2|||<|0.001|TWO_SIDED|95.0|6.1|22.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||22.3|6.1|<0.001
91570535|NCT01174264|183029783|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.75||||0.003|TWO_SIDED|90.0|1.3|2.34|||t-test, 2 sided|Performed on log-transformed data.||||2.34|1.30|0.003
91570536|NCT01174264|183029783|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.08||||0.65|TWO_SIDED|90.0|0.81|1.44||Performed on log-transformed data.|t-test, 2 sided|||||1.44|0.81|0.65
91570537|NCT01174264|183029784|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.74||||0.008|TWO_SIDED|90.0|1.25|2.42|||t-test, 2 sided|Performed on log-transformed data.||||2.42|1.25|0.008
91570538|NCT01174264|183029784|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12||||0.51|TWO_SIDED|90.0|0.84|1.49|||t-test, 2 sided|Performed on log-transformed data.||||1.49|0.84|0.51
91570539|NCT01174264|183029786|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
91570540|NCT01174264|183029786|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
91570541|NCT01174264|183029787|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91570542|NCT01174264|183029787|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
91570543|NCT01174264|183029788|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.16||||0.17|TWO_SIDED|90.0|0.97|1.38|||t-test, 2 sided|Performed on log-transformed data.||||1.38|0.97|0.17
91570544|NCT01174264|183029789|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.13||||0.25|TWO_SIDED|90.0|0.95|1.35|||t-test, 2 sided|Performed on log-transformed data.||||1.35|0.95|0.25
91570545|NCT01174264|183029790|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.22||||0.096|TWO_SIDED|90.0|1.0|1.48||Performed on log-transformed data.|t-test, 2 sided|||||1.48|1.00|0.096
91570546|NCT01174264|183029791|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
91570547|NCT03432390|183029792|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
91570548|NCT01185171|183029849|NON_INFERIORITY|The power of the study was conducted as a two-stage, non-inferiority phase II trial with a total sample size of 59 patients to detect a 15% lower rate than 80% achieved with TFHX, with alpha = 0.05 and beta = 0.20. In the first stage, 25 patients were recruited, with a plan to terminate if 16 or less complete responses (CR) were observed. Otherwise, additional 34 patients would be recruited and the treatment would be deemed not inferior to historical if more than 45 CRs were observed.|proportion|0.88|||<|0.01|TWO_SIDED|95.0|0.77|0.95||Ho: CR rate = 0.65 vs Ha: CR rate \> 0.65|Binomial test for a proportion|||||0.95|0.77|< 0.01
91570549|NCT01482429|183029853|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||binomial test|||||||0.03
91570550|NCT01482429|183029854|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91570551|NCT01502371|183029858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.87||||0.019|TWO_SIDED|95.0|0.64|7.09||Constrained longitudinal data analysis (cLDA) model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. Placebo||7.09|0.64|0.019
91570552|NCT01502371|183029858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.29|||<|0.001|TWO_SIDED|95.0|3.05|9.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo||9.53|3.05|<0.001
91570553|NCT01502371|183029858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.34||||0.001|TWO_SIDED|95.0|2.07|8.61||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo||8.61|2.07|0.001
91570554|NCT01502371|183029859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.15||||0.045|TWO_SIDED|95.0|0.43|37.87||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||37.87|0.43|0.045
91570555|NCT01502371|183029859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.35||||0.004|TWO_SIDED|95.0|8.63|46.08||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||46.08|8.63|0.004
91570556|NCT01502371|183029859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.01||||0.057|TWO_SIDED|95.0|-0.51|36.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||36.53|-0.51|0.057
91570557|NCT01502371|183029860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.28|TWO_SIDED|95.0|-0.08|0.27||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.27|-0.08|0.280
91570558|NCT01502371|183029860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.178|TWO_SIDED|95.0|-0.06|0.3||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.30|-0.06|0.178
91570559|NCT01502371|183029860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18||||0.045|TWO_SIDED|95.0|0.0|0.36||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.36|0.00|0.045
91570560|NCT01502371|183029861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39||||0.368|TWO_SIDED|95.0|-1.65|4.44||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. MF DPI 100 mcg QD. Only participants who received MF MDI 50 mcg BID or MF DPI 100 mcg QD were included in the statistical analysis.||4.44|-1.65|0.368
91570561|NCT02188784|183029863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.03||||0.457|TWO_SIDED|95.0|-34.38|76.43|||Regression, Linear|||||76.43|-34.38|0.4570
91570562|NCT02188784|183029864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77||||0.9487|TWO_SIDED|95.0|-24.12|22.59|||Regression, Linear|||Change from Baseline to Week 8||22.59|-24.12|0.9487
91570563|NCT02188784|183029864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.67||||0.1921|TWO_SIDED|95.0|-31.71|6.37|||Regression, Linear|||Change from Baseline to Week 16||6.37|-31.71|0.1921
91570564|NCT02188784|183029865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|182.43||||0.4296|TWO_SIDED|95.0|-272.14|637.0|||Regression, Linear|||||637.0|-272.14|0.4296
91570565|NCT02188784|183029866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.0722|TWO_SIDED|95.0|-0.33|7.52|||Regression, Linear|||Change from baseline to week 8||7.52|-0.33|0.0722
91570566|NCT02188784|183029866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.6927|TWO_SIDED|95.0|-2.83|4.24|||Regression, Linear|||Change from baseline to week 16||4.24|-2.83|0.6927
91570567|NCT02188784|183029867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.0643|TWO_SIDED|95.0|-0.21|7.33|||Regression, Linear|||||7.33|-0.21|0.0643
91570568|NCT02188784|183029868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.4006|TWO_SIDED|95.0|-1.04|2.58|||Regression, Linear|||||2.58|-1.04|0.4006
91570569|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||12.9|-30.8|
91570570|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
91570571|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||12.9|-30.8|
91570572|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||25.5|-16.4|
91570573|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||1.3|-41.7|
91570574|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||18.7|-23.3|
91570575|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||8.3|-35.2|
91570576|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||32.2|-9.5|
91570577|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||12.9|-30.8|
91570578|NCT01568112|183029878|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||25.5|-16.4|
91570579|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||8.3|-35.2|
91570580|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||32.2|-9.5|
91570581|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-39.6|3.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||3.7|-39.6|
91570582|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||27.8|-14.1|
91570583|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||1.3|-41.7|
91570584|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||27.8|-14.1|
91570585|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|-33.0|||||TWO_SIDED|95.0|-52.2|-10.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-10.6|-52.2|
91570586|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-21.0|21.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||21.0|-21.0|
91570587|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||1.3|-41.7|
91570588|NCT01568112|183029879|SUPERIORITY_OR_OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|-2.4|38.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||38.8|-2.4|
91570589|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.2|-35.6|
91570590|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||21.7|-24.7|
91570591|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||9.2|-35.6|
91570592|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.9|23.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||23.7|-22.9|
91570593|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-33.0|11.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||11.9|-33.0|
91570594|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-5.0|||||TWO_SIDED|95.0|-27.5|18.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||18.8|-27.5|
91570595|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-17.0|||||TWO_SIDED|95.0|-38.1|6.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||6.5|-38.1|
91570596|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-34.2|12.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||12.2|-34.2|
91570597|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||3.8|-40.6|
91570598|NCT01568112|183029880|SUPERIORITY_OR_OTHER||Difference in percentage|-18.0|||||TWO_SIDED|95.0|-40.2|5.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||5.5|-40.2|
91570599|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-3.0|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||-0.9|-3.0|
91570600|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|0.2|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||2.3|0.2|
91570601|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-3.2|-1.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||-1.2|-3.2|
91570602|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|0.1|2.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||2.5|0.1|
91570603|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.8|-0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||-0.7|-2.8|
91570604|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|0.1|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||2.3|0.1|
91570605|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.7|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.9|-2.7|
91570606|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.4|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||1.6|-0.4|
91570607|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.8|-1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-1.0|-2.8|
91570608|NCT01568112|183029881|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|0.2|2.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||2.2|0.2|
91570609|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.8|-1.7|
91570610|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.8|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.4|-1.8|
91570611|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.6|-2.0|
91570612|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.5|-1.9|
91570613|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.0|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.4|-2.0|
91570614|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.1|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.2|-2.1|
91570615|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.2|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||0.1|-2.2|
91570616|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.2|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.0|-2.2|
91570617|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||0.4|-2.1|
91570618|NCT01568112|183029882|SUPERIORITY_OR_OTHER||Mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.4|-0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-0.1|-2.4|
91570619|NCT01568112|183029883|SUPERIORITY_OR_OTHER||Difference in percentage|-12.0|||||TWO_SIDED|95.0|-32.2|9.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.5|-32.2|
91570620|NCT01568112|183029883|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
91570621|NCT01568112|183029884|SUPERIORITY_OR_OTHER||Difference in percentage|-22.0|||||TWO_SIDED|95.0|-41.0|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||0.1|-41.0|
91570622|NCT01568112|183029884|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
91570623|NCT01568112|183029885|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||3.8|-40.6|
91570624|NCT01568112|183029885|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-24.7|
91570625|NCT01568112|183029886|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.0|22.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||22.0|-22.0|
91570626|NCT01568112|183029886|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.5|-16.4|
91570627|NCT01568112|183029887|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.2|19.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||19.7|-24.2|
91570628|NCT01568112|183029887|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.7|-23.3|
91570629|NCT01568112|183029888|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-29.4|17.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||17.1|-29.4|
91570630|NCT01568112|183029888|SUPERIORITY_OR_OTHER||Difference in percentage|1.0|||||TWO_SIDED|95.0|-22.1|24.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||24.5|-22.1|
91570631|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.1|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||1.1|-1.1|
91570632|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.1|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.9|-1.1|
91570633|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.4|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.8|-1.4|
91570634|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.1|-1.7|
91570635|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-0.5|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.6|-0.5|
91570636|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.3|-0.7|
91570637|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.0|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.9|-1.0|
91570638|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.1|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.8|-1.1|
91570639|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.7|-0.6|
91570640|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.6|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.5|-0.6|
91570641|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.0|0.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.3|-1.0|
91570642|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.8|-0.8|
91570643|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-1.0|
91570644|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.9|-0.8|
91570645|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.7|1.1||||||Bloating||1.1|-0.7|
91570646|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.9|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.9|
91570647|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.9|-0.8|
91570648|NCT01568112|183029889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-0.7|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||1.1|-0.7|
91570649|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.0|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-1.0|
91570650|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-0.8|
91570651|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.7|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.4|-1.7|
91570652|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.2|-1.7|
91570653|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.7|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.6|-0.7|
91570654|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.8|-0.7|
91570655|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.7|-0.6|
91570656|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.2|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||1.3|-0.2|
91570657|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.4|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.4|-0.4|
91570658|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.2|-0.4|
91570659|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.6|-0.6|
91570660|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.7|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.5|-0.7|
91570661|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.1|1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||1.0|-0.1|
91570662|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.2|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-0.2|
91570663|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.8|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.8|
91570664|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.8|-0.7|
91570665|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-1.6|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||-0.0|-1.6|
91570666|NCT01568112|183029890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.5|-1.2|
91570667|NCT01568112|183029891|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
91570668|NCT01568112|183029891|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
91570669|NCT01568112|183029892|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-18.8|23.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.3|-18.8|
91570670|NCT01568112|183029892|SUPERIORITY_OR_OTHER||Difference in percentage|6.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
91570671|NCT01568112|183029893|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-32.1|14.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||14.3|-32.1|
91570672|NCT01568112|183029893|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-25.0|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-25.0|
91570673|NCT01568112|183029900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-20.9|34.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||34.1|-20.9|
91570674|NCT01568112|183029900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|10.03|||TWO_SIDED|95.0|-14.2|25.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.7|-14.2|
91570675|NCT01568112|183029901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.2|STANDARD_ERROR_OF_MEAN|24.4|||TWO_SIDED|95.0|-26.5|70.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||70.9|-26.5|
91570676|NCT01568112|183029901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|11.08|||TWO_SIDED|95.0|-20.5|23.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.6|-20.5|
91570677|NCT01568112|183029902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.5|STANDARD_ERROR_OF_MEAN|13.32|||TWO_SIDED|95.0|-9.2|44.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||44.2|-9.2|
91570678|NCT01568112|183029902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-17.2|18.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.0|-17.2|
91570679|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|4.601|||TWO_SIDED|95.0|-6.34|12.26|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||12.26|-6.34|
91570680|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-8.81|0.67|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.67|-8.81|
91570681|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|STANDARD_ERROR_OF_MEAN|7.335|||TWO_SIDED|95.0|-3.15|26.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||26.63|-3.15|
91570682|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|95.0|-2.67|6.77|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||6.77|-2.67|
91570683|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.21|STANDARD_ERROR_OF_MEAN|7.812|||TWO_SIDED|95.0|-6.72|25.14|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||25.14|-6.72|
91570684|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.152|||TWO_SIDED|95.0|-11.31|5.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||5.63|-11.31|
91570685|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|7.516|||TWO_SIDED|95.0|-18.36|12.19|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||12.19|-18.36|
91570686|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|7.141|||TWO_SIDED|95.0|-20.71|8.35|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.35|-20.71|
91570687|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|5.292|||TWO_SIDED|95.0|-22.9|6.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||6.49|-22.90|
91570688|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.33|STANDARD_ERROR_OF_MEAN|6.536|||TWO_SIDED|95.0|-30.13|11.47|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||11.47|-30.13|
91570689|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.69|STANDARD_ERROR_OF_MEAN|8.376|||TWO_SIDED|95.0|-30.02|4.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||4.63|-30.02|
91570690|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|STANDARD_ERROR_OF_MEAN|8.654|||TWO_SIDED|95.0|-29.48|6.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.32|-29.48|
91570691|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|10.274|||TWO_SIDED|95.0|-35.44|7.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||7.57|-35.44|
91570692|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|12.369|||TWO_SIDED|95.0|-33.39|18.81|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||18.81|-33.39|
91570693|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|6.472|||TWO_SIDED|95.0|-20.4|5.93|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||5.93|-20.40|
91570694|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.33|STANDARD_ERROR_OF_MEAN|34.455|||TWO_SIDED|95.0|-10.78|131.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||131.4|-10.78|
91570695|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|59.87|STANDARD_ERROR_OF_MEAN|65.007|||TWO_SIDED|95.0|-71.51|191.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||191.2|-71.51|
91570696|NCT01568112|183029903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.78|STANDARD_ERROR_OF_MEAN|40.44|||TWO_SIDED|95.0|-27.09|136.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||136.6|-27.09|
91570697|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|5.281|||TWO_SIDED|95.0|-6.79|14.68|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||14.68|-6.79|
91570698|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.563|||TWO_SIDED|95.0|-9.57|0.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.83|-9.57|
91570699|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.51|STANDARD_ERROR_OF_MEAN|8.024|||TWO_SIDED|95.0|-2.84|29.86|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||29.86|-2.84|
91570700|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-2.41|7.29|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||7.29|-2.41|
91570701|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|STANDARD_ERROR_OF_MEAN|8.143|||TWO_SIDED|95.0|-5.81|27.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||27.50|-5.81|
91570702|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-12.08|7.09|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||7.09|-12.08|
91570703|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|8.488|||TWO_SIDED|95.0|-19.03|15.64|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||15.64|-19.03|
91570704|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|STANDARD_ERROR_OF_MEAN|7.832|||TWO_SIDED|95.0|-23.93|8.11|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.11|-23.93|
91570705|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.811|||TWO_SIDED|95.0|-23.8|17.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||17.60|-23.80|
91570706|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|4.155|||TWO_SIDED|95.0|-22.75|13.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||13.00|-22.75|
91570707|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.08|STANDARD_ERROR_OF_MEAN|16.243|||TWO_SIDED|95.0|-59.2|9.05|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||9.05|-59.20|
91570708|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.95|STANDARD_ERROR_OF_MEAN|14.83|||TWO_SIDED|95.0|-54.89|6.98|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.98|-54.89|
91570709|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.49|STANDARD_ERROR_OF_MEAN|10.847|||TWO_SIDED|95.0|-35.38|10.39|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||10.39|-35.38|
91570710|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|12.542|||TWO_SIDED|95.0|-32.79|20.13|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||20.13|-32.79|
91570711|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|6.442|||TWO_SIDED|95.0|-15.87|10.41|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||10.41|-15.87|
91570712|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.89|STANDARD_ERROR_OF_MEAN|50.239|||TWO_SIDED|95.0|-22.04|185.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||185.8|-22.04|
91570713|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.52|STANDARD_ERROR_OF_MEAN|32.896|||TWO_SIDED|95.0|-40.13|93.18|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||93.18|-40.13|
91570714|NCT01568112|183029904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.78|STANDARD_ERROR_OF_MEAN|41.055|||TWO_SIDED|95.0|-31.65|135.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||135.2|-31.65|
91570715|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.626|||TWO_SIDED|95.0|-7.35|3.99|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||3.99|-7.35|
91570716|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-6.62|2.62|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||2.62|-6.62|
91570717|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|5.717|||TWO_SIDED|95.0|-11.64|12.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||12.49|-11.64|
91570718|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.48|STANDARD_ERROR_OF_MEAN|4.597|||TWO_SIDED|95.0|-14.11|5.14||||||Diarrhea||5.14|-14.11|
91570719|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.794|||TWO_SIDED|95.0|-1.1|2.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.57|-1.10|
91570720|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.775|||TWO_SIDED|95.0|-1.17|2.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.40|-1.17|
91570721|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-5.08|2.79|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||2.79|-5.08|
91570722|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|27.886|||TWO_SIDED|95.0|-42.19|79.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||79.32|-42.19|
91570723|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|2.801|||TWO_SIDED|95.0|-3.65|8.56|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||8.56|-3.65|
91570724|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.242|||TWO_SIDED|95.0|-3.71|1.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||1.83|-3.71|
91570725|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|19.649|||TWO_SIDED|95.0|-48.73|60.38|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||60.38|-48.73|
91570726|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|11.219|||TWO_SIDED|95.0|-28.38|33.91|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||33.91|-28.38|
91570727|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.36|STANDARD_ERROR_OF_MEAN|9.811|||TWO_SIDED|95.0|-35.56|6.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||6.83|-35.56|
91570728|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.12|STANDARD_ERROR_OF_MEAN|41.961|||TWO_SIDED|95.0|-22.88|157.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||157.1|-22.88|
91570729|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|98.65|STANDARD_ERROR_OF_MEAN|74.566|||TWO_SIDED|95.0|-58.01|255.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||255.3|-58.01|
91570730|NCT01568112|183029905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.27|STANDARD_ERROR_OF_MEAN|7.928|||TWO_SIDED|95.0|-5.22|27.76|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||27.76|-5.22|
91570731|NCT02366143|183029936|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|||ITT-WT population||0.74|0.52|<0.0001
91570732|NCT02366143|183029936|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Log Rank|||Teff-high WT Population||0.68|0.38|<0.0001
91570733|NCT02366143|183029937|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Log Rank|||||0.96|0.64|0.0164
91570734|NCT02366143|183029938|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.842||||0.0528|TWO_SIDED|95.0|0.707|1.002|||Log Rank|||||1.002|0.707|0.0528
91570735|NCT02366143|183029939|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||ITT-WT population||0.85|0.59|0.0002
91570736|NCT02366143|183029939|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.564||||0.0001|TWO_SIDED|95.0|0.418|0.76|||Log Rank|||Teff-high WT Population||0.760|0.418|0.0001
91570737|NCT02366143|183029940|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.492|||<|0.0001|TWO_SIDED|95.0|0.374|0.649|||Log Rank|||Teff-high Population||0.649|0.374|<.0001
91570738|NCT02366143|183029940|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.517|0.72|||Log Rank|||ITT Population||0.720|0.517|<.0001
91570739|NCT02366143|183029942|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.471|||<|0.0001|TWO_SIDED|95.0|0.352|0.647|||Log Rank|||TC2/3 or IC2/3 Subgroup||0.647|0.352|<.0001
91570740|NCT02366143|183029942|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.386|0.639|||Log Rank|||TC1/2/3 or IC1/2/3 Subgroup||0.639|0.386|<.0001
91570741|NCT02366143|183029943|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.824||||0.2765|TWO_SIDED|95.0|0.58|1.169|||Log Rank|||TC2/3 or IC2/3, WT ITT||1.169|0.580|0.2765
91570742|NCT02366143|183029943|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.771||||0.0829|TWO_SIDED|95.0|0.575|1.035|||Log Rank|||TC1/2/3 or IC1/2/3, WT ITT||1.035|0.575|0.0829
91570743|NCT02366143|183029944|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.709||||0.0073|TWO_SIDED|95.0|0.551|0.913|||Log Rank|||TC1/2/3 or IC1/2/3 ITT-WT||0.913|0.551|0.0073
91570744|NCT02366143|183029944|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.662||||0.0097|TWO_SIDED|95.0|0.484|0.907|||Log Rank|||TC2/3 or IC2/3 Population||0.907|0.484|0.0097
91570745|NCT02366143|183029945|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.831||||0.2843|TWO_SIDED|95.0|0.592|1.167|||Log Rank|||Teff high-WT||1.167|0.592|0.2843
91570746|NCT02366143|183029945|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.802||||0.1861|TWO_SIDED|95.0|0.579|1.113|||Log Rank|||Teff high||1.113|0.579|0.1861
91570747|NCT02366143|183029945|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.764||||0.006|TWO_SIDED|95.0|0.63|0.926|||Log Rank|||ITT||0.926|0.630|0.0060
91570748|NCT02366143|183029946|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.786||||0.0894|TWO_SIDED|95.0|0.595|1.038|||Log Rank|||Teff high-WT||1.038|0.595|0.0894
91570749|NCT02366143|183029946|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.815||||0.1276|TWO_SIDED|95.0|0.626|1.061|||Log Rank|||Teff high||1.061|0.626|0.1276
91514161|NCT02347761|182900400|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mea Difference (SE)|0.1036|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0663|0.1409||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|MMixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint|standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1409|0.0663|<0.0001
91570750|NCT02366143|183029946|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.861||||0.0681|TWO_SIDED|95.0|0.733|1.011|||Log Rank|||ITT||1.011|0.733|0.0681
91570751|NCT02366143|183029947|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.901||||0.4599|TWO_SIDED|95.0|0.683|1.188|||Log Rank|||Teff high-WT ITT||1.188|0.683|0.4599
91570752|NCT02366143|183029948|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.523|||<|0.0001|TWO_SIDED|95.0|0.406|0.675|||Log Rank|||ITT-WT||0.675|0.406|<.0001
91570753|NCT02366143|183029948|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.283|0.624|||Log Rank|||Teff-high WT||0.624|0.283|<.0001
91570754|NCT02366143|183029950|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|6.68||||0.0697|TWO_SIDED|95.0|-0.54|13.9|||Z-test|||1-Year ITT-WT Population||13.90|-0.54|0.0697
91570755|NCT02366143|183029950|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.71||||0.0347|TWO_SIDED|95.0|0.7|18.73|||Z-test|||2-Year ITT-WT Population||18.73|0.70|0.0347
91570756|NCT02366143|183029950|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.89||||0.089|TWO_SIDED|95.0|-1.51|21.29|||Z-test|||1-Year Teff-high WT Population||21.29|-1.51|0.0890
91570757|NCT02366143|183029950|OTHER|Stratified Analysis|Difference in Event Free Rate|10.34||||0.1336|TWO_SIDED|95.0|-3.17|23.84|||Z-test|||2-Year Teff-high WT Population||23.84|-3.17|0.1336
91570758|NCT02366143|183029951|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|4.18||||0.2624|TWO_SIDED|95.0|-3.13|11.48|||Z-test|||1-Year ITT-WT Population||11.48|-3.13|0.2624
91570759|NCT02366143|183029951|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.67||||0.0088|TWO_SIDED|95.0|2.43|16.9|||Z-test|||2-Year ITT-WT Population||16.90|2.43|0.0088
91570760|NCT02366143|183029951|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|10.56||||0.0649|TWO_SIDED|95.0|-0.65|21.77|||Z-test|||1-Year Teff-high WT Population||21.77|-0.65|0.0649
91570761|NCT02366143|183029951|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|7.27||||0.212|TWO_SIDED|95.0|-4.15|18.69|||Z-test|||2-Year Teff-high WT Population||18.69|-4.15|0.2120
91570762|NCT02366143|183029952|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.909||||0.6899|TWO_SIDED|95.0|0.571|1.45|||Log Rank|||Teff-high WT Population||1.450|0.571|0.6899
91570763|NCT02366143|183029952|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.671||||0.1043|TWO_SIDED|95.0|0.413|1.089|||Log Rank|||Teff-high WT Population||1.089|0.413|0.1043
91570764|NCT02366143|183029952|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.232||||0.173||95.0|0.912|1.665|||Log Rank|||ITT WT||1.665|0.912|0.1730
91570765|NCT02366143|183029952|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.084||||0.6145|TWO_SIDED|95.0|0.792|1.483|||Log Rank|||ITT WT||1.483|0.792|0.6145
91570766|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.8816|TWO_SIDED|95.0|0.614|1.763|||Log Rank|||Cough for Teff-high WT ITT population||1.763|0.614|0.8816
91570767|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.741||||0.2995|TWO_SIDED|95.0|0.419|1.309|||Log Rank|||Cough for Teff-high WT ITT Population||1.309|0.419|0.2995
91570768|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.936||||0.7578|TWO_SIDED|95.0|0.616|1.422|||Log Rank|||Dyspnea in Teff-high WT Population||1.422|0.616|0.7578
91570769|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.847|TWO_SIDED|95.0|0.694|1.56|||Log Rank|||Dyspnea in Teff-high WT Population||1.560|0.694|0.8470
91570770|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.659||||0.1289|TWO_SIDED|95.0|0.383|1.133|||Log Rank|||Pain in Chest in Teff-high WT Population||1.133|0.383|0.1289
91570771|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.729||||0.2381|TWO_SIDED|95.0|0.43|1.235|||Log Rank|||Pain in Chest in Teff-high WT Population||1.235|0.430|0.2381
91570772|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.09||||0.7163|TWO_SIDED|95.0|0.685|1.732|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.732|0.685|0.7163
91570773|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.693||||0.1502|TWO_SIDED|95.0|0.42|1.145|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.145|0.420|0.1502
91570774|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.01||||0.9568|TWO_SIDED|95.0|0.713|1.43|||Log Rank|||Cough in ITT-WT Population||1.430|0.713|0.9568
91570775|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.891||||0.5377|TWO_SIDED|95.0|0.619|1.284|||Log Rank|||Cough in ITT-WT Population||1.284|0.619|0.5377
91570776|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.4012|TWO_SIDED|95.0|0.685|1.163|||Log Rank|||Dyspnea in ITT-WT Population||1.163|0.685|0.4012
91570777|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.05||||0.7149|TWO_SIDED|95.0|0.809|1.363|||Log Rank|||Dyspnea in ITT-WT Population||1.363|0.809|0.7149
91570778|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.057||||0.7126|TWO_SIDED|95.0|0.786|1.422|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.422|0.786|0.7126
91570779|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.921||||0.6053|TWO_SIDED|95.0|0.675|1.258|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.258|0.675|0.6053
91570780|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.829||||0.3134|TWO_SIDED|95.0|0.576|1.194|||Log Rank|||Pain in Chest in ITT-WT Population||1.194|0.576|0.3134
91570781|NCT02366143|183029953|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.91||||0.6115|TWO_SIDED|95.0|0.633|1.309|||Log Rank|||Pain in Chest in ITT-WT Population||1.309|0.633|0.6115
91570782|NCT00575042|183029990|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Sample size calculation estimated that with 20 patients, and assuming a 10% drop-out rate, the study would have 80% power to detect a response rate in 35% or more of the study patients. A two-sided p value\<0.05 was considered statistically significant.||||<0.0001
91570783|NCT01458522|183030010|OTHER|||||||0.512|||||||Poisson regression model|||||||0.512
91570784|NCT01777126|183030066|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.||||<0.001
91570785|NCT01777126|183030069|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were \< 0.05.||||<0.01
91570786|NCT01777126|183030070|SUPERIORITY_OR_OTHER||proportion|||||0.487||95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher's Exact Test. Results were considered statistically significant if p-values were \< 0.05.||||0.487
91570787|NCT01777126|183030071|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.302
91570788|NCT01777126|183030072|SUPERIORITY_OR_OTHER||Proportion|||||0.117|TWO_SIDED|95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher's Exact Test. The result was considered statistically significant if p-values were \< 0.05.||||0.117
91570789|NCT01777126|183030073|SUPERIORITY_OR_OTHER||Proportion|||||0.049||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.049
91570790|NCT01777126|183030074|SUPERIORITY_OR_OTHER||proportion|||||0.698||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.698
91570791|NCT02706951|183030082|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|26.5|||<|0.001|TWO_SIDED|95.0|17.5|35.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||35.6|17.5|<0.001
91570792|NCT02706951|183030082|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|30.0|||<|0.001|TWO_SIDED|95.0|21.0|38.9||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||38.9|21.0|<0.001
91570793|NCT02706951|183030083|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|16.8|33.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||33.7|16.8|<0.001
91570794|NCT02706951|183030083|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|33.6|||<|0.001|TWO_SIDED|95.0|25.1|42.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||42.1|25.1|<0.001
91570795|NCT02706951|183030084|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Least Squares (LS) Mean Difference|-1.08|||<|0.001|TWO_SIDED|95.0|-1.32|-0.85||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.85|-1.32|<0.001
91570796|NCT02706951|183030084|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.64|-1.17||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-1.17|-1.64|<0.001
91570797|NCT02706951|183030085|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.22||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.22|-0.43|<0.001
91570798|NCT02706951|183030085|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.51|-0.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.30|-0.51|<0.001
91570799|NCT02706951|183030086|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|3.97|||<|0.001|TWO_SIDED|95.0|2.52|5.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||5.42|2.52|<0.001
91570800|NCT02706951|183030086|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|5.87|||<|0.001|TWO_SIDED|95.0|4.42|7.32||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||7.32|4.42|<0.001
91570801|NCT02706951|183030087|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.8|26.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||26.8|12.8|<0.001
91570802|NCT02706951|183030087|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|32.1|||<|0.001|TWO_SIDED|95.0|24.6|39.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||39.7|24.6|<0.001
91570803|NCT02706951|183030088|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-41.53||||0.001|TWO_SIDED|95.0|-66.56|-16.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-16.50|-66.56|0.001
91570804|NCT02706951|183030088|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-49.31|||<|0.001|TWO_SIDED|95.0|-74.23|-24.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-24.40|-74.23|<0.001
91570805|NCT02706951|183030089|SUPERIORITY||Response Rate Difference|26.7|||<|0.001|TWO_SIDED|95.0|18.5|34.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||34.8|18.5|<0.001
91570806|NCT02706951|183030089|SUPERIORITY||Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|28.6|45.0||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||45.0|28.6|<0.001
91570807|NCT02706951|183030090|SUPERIORITY||Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.8|25.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||25.8|13.8|<0.001
91570808|NCT02706951|183030090|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|23.6|36.9||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||36.9|23.6|<0.001
91570809|NCT03491215|183030091|OTHER|Comparison|GMR|0.801|||||TWO_SIDED|90.0|0.49|1.311||||||Group 3 vs Group 2||1.311|0.490|
91570810|NCT03491215|183030091|OTHER|Comparison|GMR|0.991|||||TWO_SIDED|90.0|0.532|1.846||||||Group 3 vs. Group 1||1.846|0.532|
91570811|NCT03491215|183030091|OTHER|Comparison|GMR|1.237|||||TWO_SIDED|90.0|0.639|2.394||||||Group 2 vs. Group 1||2.394|0.639|
91570812|NCT03491215|183030092|OTHER|Comparison|GMR|0.709|||||TWO_SIDED|90.0|0.425|1.184||||||Group 3 vs. Group 2||1.184|0.425|
91570813|NCT03491215|183030092|OTHER|Comparison|GMR|0.968|||||TWO_SIDED|90.0|0.506|1.851||||||Group 3 vs. Group 1||1.851|0.506|
91570814|NCT03491215|183030092|OTHER|Comparison|GMR|1.365|||||TWO_SIDED|90.0|0.686|2.714||||||Group 2 vs. Group 1||2.714|0.686|
91570815|NCT03491215|183030094|OTHER|Comparison|GMR|0.759|||||TWO_SIDED|90.0|0.245|2.352||||||Group 3 vs. Group 2||2.352|0.245|
91570816|NCT03491215|183030094|OTHER|Comparison|GMR|0.516|||||TWO_SIDED|90.0|0.15|1.784||||||Group 3 vs. Group 1||1.784|0.150|
91570817|NCT03491215|183030094|OTHER|Comparison|GMR|0.681|||||TWO_SIDED|90.0|0.178|2.597||||||Group 2 vs. Group 1||2.597|0.178|
91570818|NCT03491215|183030102|SUPERIORITY||Odds Ratio (OR)|0.976|||||TWO_SIDED|95.0|0.858|1.109||||||||1.109|0.858|
91570819|NCT03491215|183030102|SUPERIORITY||Odds Ratio (OR)|0.951|||||TWO_SIDED|95.0|0.735|1.232||||||||1.232|0.735|
91570820|NCT03491215|183030103|SUPERIORITY||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.921|1.115||||||||1.115|0.921|
91570821|NCT03491215|183030103|SUPERIORITY||Hazard Ratio (HR)|1.029|||||TWO_SIDED|95.0|0.841|1.258||||||||1.258|0.841|
91570822|NCT03491215|183030104|SUPERIORITY||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|1.012|1.117||||||||1.117|1.012|
91570823|NCT03491215|183030104|SUPERIORITY||Hazard Ratio (HR)|1.132|||||TWO_SIDED|95.0|1.025|1.25||||||||1.25|1.025|
91570824|NCT02489734|183030124|SUPERIORITY||Relative risk (RR)|3.4||||0.003|TWO_SIDED|95.0|1.4|8.1|||Chi-squared|||||8.1|1.4|0.003
91570825|NCT00424554|183030134|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
91570826|NCT03634839|183030185|SUPERIORITY||Mean Difference (Final Values)|-5.184||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
91570827|NCT03634839|183030186|SUPERIORITY||Mean Difference (Final Values)|-1.881||||0.187|TWO_SIDED||||||t-test, 2 sided|||Outcome analyses will be intent-to-treat and using mixed-effects models with flavor as a within-subject factor. A significant main effect of flavor with greater liking of sweet plus cooling flavor than sweet minus cooling flavor will be considered supportive of our hypotheses.||||0.187
91570828|NCT03634839|183030187|SUPERIORITY||Mean Difference (Final Values)|-0.286||||0.135|TWO_SIDED||||||t-test, 2 sided|||||||0.135
91570829|NCT03634839|183030188|SUPERIORITY||Mean Difference (Final Values)|1.942||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.210
91570830|NCT04198948|183030189|EQUIVALENCE|Sample size calculation was performed using SAS Proc Power procedure for equivalence test in 2x2 crossover design. For an equivalence range of 80-125%, the within-subject coefficient of variation for the AUC values for gliclazide of 7.8% based on previous PK studies, and expected test/reference geometric mean ratios between 87-115%, 14 volunteers (7 individuals per sequence) are required to show the lack of interaction with 85% power.|Geometric least square mean ratio|1.13|||||TWO_SIDED|90.0|0.86|1.48|||||The TOST (two one-sided test) test of equivalence showed that the geometric mean ratio and 90% CI for gliclazide AUC(0-24) between omeprazole and placebo phase was 1.13 (0.86-1.48), with upper confidence limit above the usual 1.25 boundary.|The main evaluated outcome was systemic exposure to gliclazide, expressed as AUC(0-t). The geometric mean was calculated for gliclazide AUC(0-24). The ratio of the geometric means with 90% CIs was assessed by linear mixed models between the two treatment assignments: gliclazide and omeprazole co-administration to that of gliclazide and placebo. The obtained 90% CI was compared with the equivalence 0.8-1.25 range.||1.48|0.86|
91570831|NCT04198948|183030190|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
91570832|NCT04198948|183030191|SUPERIORITY|||||||0.055|||||||t-test, 2 sided|||||||0.055
91570833|NCT04593823|183030228|SUPERIORITY||Win Ratio|1.11|||||TWO_SIDED|95.0|0.48|2.5|||||A win ratio parameter signifies the percentage of wins that a treatment group has achieved when compared against a comparator.|||2.50|0.48|
91570834|NCT04593823|183030229|SUPERIORITY||Mean Difference (Final Values)|2.9|||>|0.999|TWO_SIDED|95.0|-17.0|15.9|||Chi-squared|||||15.9|-17.0|>0.999
91570835|NCT04593823|183030230|SUPERIORITY||Median Difference (Final Values)|-8.8||||0.459|TWO_SIDED|95.0|-36.4|13.6|||Chi-squared|||||13.6|-36.4|0.459
91570836|NCT04593823|183030232|SUPERIORITY||Least Squares Mean Difference|8.887||||0.547|TWO_SIDED|95.0|-20.01|37.784|||ANOVA|Repeated measures analysis||||37.784|-20.010|0.547
91570837|NCT04593823|183030233|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
91570838|NCT04974723|183030244|NON_INFERIORITY|Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.1||||||||1.10|0.81|
91570839|NCT04974723|183030245|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.89|1.3||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.30|0.89|
91570840|NCT04974723|183030246|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.95|1.22||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.22|0.95|
91570841|NCT03311269|183030273|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.2|-2.3||This p-value corresponds to the change from Baseline to Week 12 for both treatment groups (ClariVein RES 1% Injection and ClariVein RES 3% Injection) combined.|t-test, 2 sided|One-Sample||Continuous variables summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum and maximum. Categorical variables summarized using frequencies and percentages. All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. For efficacy analyses, missing post-treatment data will be imputed using last observation carried forward (LOCF). Missing safety data will not be imputed.||-2.3|-6.2|<0.001
91570842|NCT03311269|183030273|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-3.4||||0.011|TWO_SIDED|95.0|-5.8|-1.0||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.0|-5.8|0.011
91570843|NCT03311269|183030273|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-5.1||||0.01|TWO_SIDED|95.0|-8.7|-1.6||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.6|-8.7|0.010
91570844|NCT03311269|183030273|OTHER|An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate|Least-Squares Mean Difference|-1.2||||0.531|TWO_SIDED|95.0|-3.7|1.3||This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection).|ANCOVA|||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||1.3|-3.7|0.531
91570845|NCT03311269|183030274|OTHER||Descriptive (Percentage)|94.4|||||TWO_SIDED|95.0|72.7|99.9|||||The count of the combined treatment group for the elimination of saphenous vein reflux at Week 12 posttreatment is 17/18 (94.4%).|The secondary efficacy endpoint, the elimination of saphenous vein reflux at Week 12 posttreatment, will be summarized for both treatments combined using the count and percentage, together with a 95% Wilson (score) confidence interval for the proportion.||99.9|72.7|
91570846|NCT03311269|183030274|OTHER||Percentage Difference|11.1||||1|TWO_SIDED|95.0|-20.5|42.8||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.|Chi-squared|||For elimination of saphenous vein reflux at Week 12 posttreatment, the treatment difference for ClariVein RES 1% Injection versus ClariVein RES 3% Injection for the proportion was assessed by a chi-square test together with a 95% Wilson (score) confidence interval for the treatment difference.||42.8|-20.5|1.000
91570847|NCT00409409|183030281|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||||||0.0010
91570848|NCT03599622|183030282|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|4.3||||0.5812|TWO_SIDED|95.0|-11.0|19.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.5|-11.0|0.5812
91570849|NCT03599622|183030282|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.2||||0.5812|TWO_SIDED|95.0|0.6|2.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.5|0.6|0.5812
91570850|NCT03599622|183030282|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-6.3||||0.372|TWO_SIDED|95.0|-20.2|7.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||7.6|-20.2|0.3720
91570851|NCT03599622|183030282|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.7||||0.372|TWO_SIDED|95.0|0.3|1.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.5|0.3|0.3720
91570852|NCT03599622|183030283|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|15.0||||0.0198|TWO_SIDED|95.0|3.7|26.3||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||26.3|3.7|0.0198
91570853|NCT03599622|183030283|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|3.4||||0.0198|TWO_SIDED|95.0|1.2|9.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.8|1.2|0.0198
91570854|NCT03599622|183030283|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.2||||0.1584|TWO_SIDED|95.0|-2.6|19.0||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.0|-2.6|0.1584
91570855|NCT03599622|183030283|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|2.1||||0.1584|TWO_SIDED|95.0|0.7|6.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||6.1|0.7|0.1584
91570856|NCT03599622|183030284|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|7.7||||0.3464|TWO_SIDED|95.0|-8.2|23.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||23.6|-8.2|0.3464
91570857|NCT03599622|183030284|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.4||||0.3464|TWO_SIDED|95.0|0.7|2.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.8|0.7|0.3464
91570858|NCT03599622|183030284|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-1.2||||0.8857|TWO_SIDED|95.0|-17.0|14.7||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||14.7|-17.0|0.8857
91570859|NCT03599622|183030284|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.0||||0.8857|TWO_SIDED|95.0|0.5|1.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.9|0.5|0.8857
91570860|NCT03599622|183030285|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.1||||0.2841|TWO_SIDED|95.0|-6.7|22.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||22.9|-6.7|0.2841
91570861|NCT03599622|183030285|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.5||||0.2841|TWO_SIDED|95.0|0.7|3.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||3.1|0.7|0.2841
91570862|NCT03599622|183030285|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-4.2||||0.5417|TWO_SIDED|95.0|-17.6|9.2||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.2|-17.6|0.5417
91570863|NCT03599622|183030285|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.8||||0.5417|TWO_SIDED|95.0|0.3|1.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.8|0.3|0.5417
91570864|NCT03599622|183030286|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.3|-1.8|||ANCOVA|||||-1.8|-4.3|
91570865|NCT03599622|183030286|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0428|TWO_SIDED|95.0|-3.7|-0.1||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.1|-3.7|0.0428
91570866|NCT03599622|183030286|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.8|-2.0|||ANCOVA|||||-2.0|-4.8|
91570867|NCT03599622|183030286|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.95||0.0177|TWO_SIDED|95.0|-4.1|-0.4||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.4|-4.1|0.0177
91570868|NCT03599622|183030286|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.6|0.3||||||||0.3|-2.6|
91570869|NCT03599622|183030286|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-9.7|-2.3|||ANCOVA|||||-2.3|-9.7|
91570870|NCT02485899|183030287|OTHER||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.06|0.33|||Cox Proportional Hazards model|||||0.33|0.06|<0.0001
91570871|NCT02485899|183030288|OTHER||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED||||||Cox Proportional Hazards model|||||||<0.0001
91570872|NCT00823836|183030302|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of ropinirole PR/XR tablets to ropinirole IR tablets was assessed with a non-inferiority margin of 2.5.|Median Difference (Net)|0.34||||0.702|TWO_SIDED|95.0|-1.41|2.09||Analysis of covariance (ANCOVA) model: value of change from Week 0 at Week 24 = treatment group + Week 0 value|ANCOVA|||||2.09|-1.41|0.702
91570873|NCT01130168|183030364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0005|TWO_SIDED|95.0|-15.3|-10.9|||ANOVA|||||-10.9|-15.3|<0.0005
91570874|NCT01130168|183030364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.016|TWO_SIDED|95.0|-4.9|-0.6|||ANOVA|||||-0.6|-4.9|0.016
91570875|NCT01130168|183030365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.407|TWO_SIDED|95.0|-1.7|4.3|||ANOVA|||||4.3|-1.7|0.407
91570876|NCT01130168|183030365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.0005|TWO_SIDED|95.0|-8.9|-2.9|||ANOVA|||||-2.9|-8.9|<0.0005
91570877|NCT01130168|183030366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.0005|TWO_SIDED|95.0|-21.2|-10.1|||ANOVA|||||-10.1|-21.2|<0.0005
91570878|NCT01130168|183030366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.001|TWO_SIDED|95.0|-17.4|-6.3|||ANOVA|||||-6.3|-17.4|0.001
91570879|NCT01130168|183030367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.186|TWO_SIDED|95.0|-9.5|1.8|||ANOVA|||||1.8|-9.5|0.186
91570880|NCT01130168|183030367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|||<|0.0005|TWO_SIDED|95.0|-21.7|-10.5|||ANOVA|||||-10.5|-21.7|<0.0005
91570881|NCT01130168|183030368|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.2|||<|0.0005|TWO_SIDED|95.0|-12.1|-6.4|||ANOVA|||||-6.4|-12.1|<0.0005
91570882|NCT01130168|183030368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.035|TWO_SIDED|95.0|-6.0|-0.3|||ANOVA|||||-0.3|-6.0|0.035
91570883|NCT01130168|183030369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.428|TWO_SIDED|95.0|-6.1|2.6|||ANOVA|||||2.6|-6.1|0.428
91570884|NCT01130168|183030369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.0005|TWO_SIDED|95.0|-13.1|-4.5|||ANOVA|||||-4.5|-13.1|<0.0005
91570885|NCT01130168|183030370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0005|TWO_SIDED|95.0|-17.5|-10.0|||ANOVA|||||-10.0|-17.5|<0.0005
91570886|NCT01130168|183030370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.015|TWO_SIDED|95.0|-8.5|-1.0|||ANOVA|||||-1.0|-8.5|0.015
91570887|NCT01130168|183030371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.112|TWO_SIDED|95.0|-9.9|1.0|||ANOVA|||||1.0|-9.9|0.112
91570888|NCT01130168|183030371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|||<|0.0005|TWO_SIDED|95.0|-20.7|-9.8|||ANOVA|||||-9.8|-20.7|<0.0005
91570889|NCT01130168|183030372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.0005|TWO_SIDED|95.0|-11.8|-6.2|||ANOVA|||||-6.2|-11.8|<0.0005
91570890|NCT01130168|183030372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.039|TWO_SIDED|95.0|-5.8|-0.2|||ANOVA|||||-0.2|-5.8|0.039
91570891|NCT01130168|183030373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.267|TWO_SIDED|95.0|-6.6|1.8|||ANOVA|||||1.8|-6.6|0.267
91570892|NCT01130168|183030373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0005|TWO_SIDED|95.0|-12.7|-4.3|||ANOVA|||||-4.3|-12.7|<0.0005
91570893|NCT02635386|183030374|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measure||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
91570894|NCT02635386|183030375|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570895|NCT02635386|183030376|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570896|NCT02635386|183030377|SUPERIORITY||||||<|0.0001|||||||ANOVA|one way with Bonferroni contrast||One way ANOVA with Bonferroni test to compare differences between groups if significant||||<0.0001
91570897|NCT02635386|183030378|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570898|NCT02635386|183030379|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measure design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
91570899|NCT02635386|183030380|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570900|NCT02635386|183030381|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570901|NCT02635386|183030382|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570902|NCT02635386|183030383|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.01
91570903|NCT02635386|183030384|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
91570904|NCT02635386|183030385|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570905|NCT02635386|183030386|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
91570906|NCT02635386|183030387|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
91570907|NCT02635386|183030388|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570908|NCT02635386|183030389|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
91570909|NCT02635386|183030390|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||>0.05
91570910|NCT02635386|183030391|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
91570911|NCT02635386|183030392|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
91570912|NCT02635386|183030393|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
91570913|NCT02635386|183030394|SUPERIORITY||||||<|0.001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.001
91570914|NCT02635386|183030395|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
91570915|NCT02635386|183030396|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
91570916|NCT00745498|183030399|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||With study power of 80%, a significance level of 0.05, and the assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated.||||<0.05
91570917|NCT02804399|183030406|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|14.74|||||TWO_SIDED|90.0|12.78|17.01||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||17.01|12.78|
91570918|NCT02804399|183030407|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|23.88|||||TWO_SIDED|90.0|21.58|26.43||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||26.43|21.58|
91570919|NCT02804399|183030408|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|13.96|||||TWO_SIDED|90.0|12.09|16.12||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||16.12|12.09|
91570920|NCT00691678|183030567|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.004|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.||||0.004
91570921|NCT05896696|183030611|OTHER||Mean Difference (Final Values)|-1.87|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.26|||Paired sample t-test|||||-1.26|-2.49|<0.0001
91570922|NCT05896696|183030612|OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.73|||paired sample t-test|||||-0.73|-1.70|<0.0001
91570923|NCT01536587|183030638|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||paired t-Test, 2-sided|||||||0.5062
91570924|NCT02666664|183030685|SUPERIORITY||Difference in LS mean|-18.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-20.0|-16.1|||ANCOVA|||||-16.1|-20|<0.001
91570925|NCT02666664|183030687|SUPERIORITY||Difference in LS mean|-16.1|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|-18.2|-14.0|||ANCOVA|||||-14|-18.2|<0.001
91570926|NCT02666664|183030688|SUPERIORITY||Difference in LS mean|-13.3|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-15.1|-11.6|||ANCOVA|||||-11.6|-15.1|<0.001
91570927|NCT02666664|183030689|SUPERIORITY||Difference in LS mean|-11.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-12.5|-9.8|||ANCOVA|||||-9.8|-12.5|<0.001
91570928|NCT02666664|183030690|SUPERIORITY||Difference in LS mean|-11.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-13.6|-10.2|||ANCOVA|||||-10.2|-13.6|<0.001
91570929|NCT02666664|183030691|SUPERIORITY||Location shift|-21.5|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-26.96|-16.0|||Wilcoxon (Mann-Whitney)|||||-16|-26.96|<0.001
91570930|NCT02666664|183030692|SUPERIORITY||Difference in LS mean|-13.6|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-15.8|-11.3|||ANCOVA|||||-11.3|-15.8|<0.001
91570931|NCT02666664|183030701|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
91570932|NCT00476242|183030713|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||||||.047
91570933|NCT01667406|183030721|OTHER|Fishers exact conditional test was used to confirm significance|Mean Difference (Final Values)|6.0|||||ONE_SIDED|95.0||||||||Data presented using descriptive statistics. Confidence intervals were derived for the difference between the means of different doses.||||
91570934|NCT01667406|183030721|OTHER||||||<|0.05|||||||Fisher Exact|||Phase 2||||<0.05
91570935|NCT01667406|183030721|OTHER||Odds Ratio (OR)|0.05|||<|0.05|ONE_SIDED|95.0|||||Regression, Logistic||Estimate of difference in success rates and estimate of odds ratio for success were derived, with P value comparing 2 treatment groups, 95% conﬁdence intervals.|Phase 3||||<0.05
91570936|NCT01667406|183030722|OTHER|secondary outcomes were analysed using descriptive statistics.||||||||||||||||Study data were summarised using standard descriptive methods. Continuous variables following a normal distribution have been summarised using mean and SD.|secondary outcomes were analysed using descriptive statistics.|||
91570937|NCT03865953|183030727|SUPERIORITY|Analysis used a two-period two-treatment crossover design|Mean Difference (Net)|-0.14||||0.67|TWO_SIDED|95.0|-0.76|0.49|||Mixed Models Analysis|||Subject numbers gave a 90% power to demonstrate a statistically significant difference in the mean change from baseline NPRS for the active treatment compared with placebo of at least 1 unit, with a two sided test at a 5% level of significance||0.49|-0.76|0.67
91570938|NCT02232399|183030749|OTHER|||||||0.45||||||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.|Mixed Models Analysis|Unstructured covariance pattern was assumed.||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.||||0.45
91570939|NCT02232399|183030750|OTHER|||||||0.7|||||||Regression, Logistic|||||||0.70
91570940|NCT02309346|183030758|NON_INFERIORITY|The non-inferiority margin was defined as a 2% difference. The sample size calculation aimed for 90% power at a 5% one-sided significance level, assuming clinical cure rates of 99% (standard arm) and 100% (experimental arm). This required 95 patients per arm, with a target enrollment of 100 per arm to account for potential dropouts.|Difference between 2 proportions|-0.02||||0.06|ONE_SIDED|95.0|-0.02||||Chi-squared|The 95% confidence interval for the difference in proportions between the two arms was calculated.||The null hypothesis (H₀) was that the treatment success rate of the once-daily clindamycin regimen is inferior to that of the thrice-daily regimen by a pre-specified non-inferiority margin (delta) of 2%. To achieve 90% power with a one-sided significance level (alpha) of 0.05 to reject the null hypothesis, a sample size of approximately 95 patients per group was required.|||-0.02|0.06
91570941|NCT01777334|183030761|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001|TWO_SIDED|95.0|0.081|0.144|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.144|0.081|<0.001
91570942|NCT00107978|183030818|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|2.5||||||95.0|-2.9|7.9||p-values were not calculated in deference to confidence intervals.|2-sided 95% confidence interval|2-sided 95% confidence interval calculated on the difference in cure rates between treatment groups.||||7.9|-2.9|
91570943|NCT02669407|183030820|OTHER|Single group|||||<|0.001|||||||Tukey's method|||||||<0.001
91570944|NCT02669407|183030821|OTHER|Single group||||||0.001|||||||Tukey's method|||Baseline, 30 minutes||||0.001
91570945|NCT02669407|183030822|OTHER|Single group||||||0.007|||||||Tukey's method|||baseline, 30 minutes||||0.007
91570946|NCT02669407|183030826|OTHER|Single group||||||0.237|||||||t-test, 2 sided|||Change in left ventricular end diastolic dimension||||0.237
91570947|NCT02669407|183030826|OTHER|Single group||||||0.586|||||||t-test, 2 sided|||Change in left ventricular end systolic dimension||||0.586
91570948|NCT02669407|183030827|OTHER|Single group||||||0.175|||||||t-test, 2 sided|||||||0.175
91570949|NCT02669407|183030829|OTHER|Single group||||||0.061|||||||t-test, 2 sided|||||||0.061
91570950|NCT02669407|183030830|OTHER|Single group||||||0.787|||||||t-test, 2 sided|||||||0.787
91570951|NCT02669407|183030832|OTHER|Single group||||||0.606|||||||t-test, 2 sided|||Baseline, 90 minutes||||0.606
91570952|NCT02669407|183030832|OTHER|Single group||||||0.045|||||||t-test, 2 sided|||Baseline, 24 hours||||0.045
91570953|NCT00458393|183030863|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|STANDARD_ERROR_OF_MEAN|0.105||0.002|TWO_SIDED|95.0|0.404|0.824||secondary p-value given.|Log Rank|stratified by site|Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100\*(1-HR)|Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.||.824|.404|0.002
91570954|NCT00458393|183030864|SUPERIORITY||Risk Ratio (RR)|1.33||||0.28|TWO_SIDED|95.0|0.79|2.25||p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p \< 0.05|Fisher Exact||||Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/|2.25|0.79|0.28
91570955|NCT00458393|183030865|SUPERIORITY||Risk Ratio (RR)|1.3||||0.54|TWO_SIDED|95.0|0.57|2.96|||Fisher Exact|||||2.96|.57|0.54
91570956|NCT00458393|183030866|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5|TWO_SIDED|95.0|0.65|1.23|||Log Rank|||||1.23|0.65|0.50
91570957|NCT00458393|183030867|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.92|TWO_SIDED|95.0|0.79|1.23|||Log Rank|||||1.23|0.79|0.92
91570958|NCT00458393|183030868|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Null hypothesis of no difference||||1.00
91570959|NCT00458393|183030868|SUPERIORITY|Desc|Risk Difference (RD)|0.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
91570960|NCT00458393|183030869|SUPERIORITY||Mean Difference (Net)|-0.91||||0.001|TWO_SIDED|||||\< 0.05 for statistical significance. no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.001
91570961|NCT00458393|183030870|SUPERIORITY||Median Difference (Net)|-3.8||||0.009|TWO_SIDED|95.0|-6.6|-0.95|||median regression|||||-0.95|-6.6|0.009
91570962|NCT00458393|183030871|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|-9.3|9.3|||median regression|||||9.3|-9.3|1.00
91570963|NCT00458393|183030872|SUPERIORITY||Median Difference (Net)|-2.2||||0.19|TWO_SIDED|95.0|-5.5|1.1|||median regression|||||1.1|-5.5|0.19
91570964|NCT00458393|183030873|SUPERIORITY||Mean Difference (Net)|0.08||||0.56|TWO_SIDED|95.0|-0.18|0.33|||t-test, 2 sided|||||0.33|-.18|0.56
91570965|NCT00458393|183030874|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||Null hypothesis is the proportion of mutations is identical.|Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/|||1.00
91570966|NCT00458393|183030875|SUPERIORITY||Mean Difference (Net)|-7.0||||0.32|TWO_SIDED|95.0|-69.0|54.0|||Mixed Models Analysis|||||54|-69|0.32
91570967|NCT00458393|183030876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.005||||0.53|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||Null hypothesis is equal proportion of pills returned||0.01|-0.02|0.53
91570968|NCT00458393|183030877|SUPERIORITY||Mean Difference (Net)|0.25||||0.7|TWO_SIDED|95.0|-1.1|1.6|||t-test, 2 sided||||Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/|1.6|-1.1|0.70
91570969|NCT00458393|183030878|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|||||Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
91570970|NCT00458393|183030879|SUPERIORITY||Median Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.42|0.42||Not adjusted for multiple comparisons, a priori threshold for statistical significance, p \< 0.05|Wilcoxon (Mann-Whitney)||||Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497|.42|-.42|0.76
91570971|NCT00458393|183030880|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.008||||0.68|TWO_SIDED|95.0|-0.047|0.03|||Chi-squared|||Null is no difference between arms||0.030|-0.047|0.68
91570972|NCT00458393|183030881|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||Null hypothesis of no difference between the arms||1.43|0.89|0.30
91570973|NCT00458393|183030882|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.41|TWO_SIDED|95.0|0.8|1.7|||Log Rank||||Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/|1.7|0.8|0.41
91570974|NCT00458393|183030883|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.34|1.09|||Log Rank|||||1.09|0.34|0.09
91570975|NCT05178979|183030887|SUPERIORITY||Wald Chi-Square|1.94||||0.38|TWO_SIDED|||||Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.38
91570976|NCT05178979|183030887|SUPERIORITY||unstandardized beta|0.93|STANDARD_ERROR_OF_MEAN|4.63||0.84|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.84
91570977|NCT05178979|183030887|SUPERIORITY||unstandardized beta|-2.62|STANDARD_ERROR_OF_MEAN|3.87||0.5|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.50
91570978|NCT05178979|183030888|SUPERIORITY||Wald Chi-square|2.0||||0.37|TWO_SIDED|||||Models control for clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.37
91570979|NCT05178979|183030888|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 6-month follow-up|Regression, Linear|Model controls for clinic||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.18
91570980|NCT05178979|183030888|SUPERIORITY||unstandardized beta|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.19|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 12-month follow-up|Regression, Linear|Model controls for clinic|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.19
91570981|NCT05178979|183030889|SUPERIORITY||Wald Chi-square|10.84||||0.004|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
91570982|NCT05178979|183030889|SUPERIORITY||unstandardized beta|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||<0.001
91570983|NCT05178979|183030889|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.86|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.86
91570984|NCT05178979|183030890|SUPERIORITY||Wald Chi-square|21.42|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Logistic||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
91570985|NCT05178979|183030890|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||0.81
91570986|NCT05178979|183030890|SUPERIORITY||unstandardized beta|-0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||<0.001
91570987|NCT05178979|183030891|SUPERIORITY||Wald Chi-square|150.43|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
91570988|NCT05178979|183030891|SUPERIORITY||unstandardized beta|0.17|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|||||||0.002
91570989|NCT05178979|183030891|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|||||||0.03
91570990|NCT05178979|183030892|SUPERIORITY||Wald Chi-square|8.72||||0.01|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
91570991|NCT05178979|183030892|SUPERIORITY||unstandardized beta|0.42|STANDARD_ERROR_OF_MEAN|0.29||0.15|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.15
91570992|NCT05178979|183030892|SUPERIORITY||unstandardized beta|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.008
91570993|NCT05178979|183030893|SUPERIORITY||Wald Chi-square|172.52|||<|0.001|TWO_SIDED|||||Models control for clinic and income and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
91570994|NCT05178979|183030893|SUPERIORITY||unstandardized beta|0.14|STANDARD_ERROR_OF_MEAN|0.34||0.68|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||0.68
91570995|NCT05178979|183030893|SUPERIORITY||unstandardized beta|-0.83|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||<0.001
91570996|NCT05178979|183030894|SUPERIORITY|Models control for clinic, income, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|25.27|||<|0.001|TWO_SIDED||||||Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
91570997|NCT05178979|183030894|SUPERIORITY||unstandardized beta|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.1|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points.||||||0.10
91570998|NCT05178979|183030894|SUPERIORITY||unstandardized beta|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.54|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 12-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points||||||0.54
91570999|NCT05178979|183030895|SUPERIORITY|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|36.04|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
91571000|NCT05178979|183030895|SUPERIORITY||unstandardized beta|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.97|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||0.97
91571001|NCT05178979|183030895|SUPERIORITY||unstandardized beta|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||<0.001
91571002|NCT05178979|183030896|SUPERIORITY||Wald Chi-square|9.46||||0.01|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
91571003|NCT05178979|183030896|SUPERIORITY||unstandardized beta|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.81
91571004|NCT05178979|183030896|SUPERIORITY||unstandardized beta|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.04
91571005|NCT05178979|183030897|SUPERIORITY||Wald Chi-square|14.77|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
91571006|NCT05178979|183030897|SUPERIORITY||unstandardized beta|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.45|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.45
91571007|NCT05178979|183030897|SUPERIORITY||unstandardized beta|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.02|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.02
91571008|NCT05178979|183030898|SUPERIORITY||Wald Chi-square|11.06||||0.004|TWO_SIDED|||||Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
91571009|NCT05178979|183030898|SUPERIORITY||unstandardized beta|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.35|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.35
91571010|NCT05178979|183030898|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.04
91571011|NCT05178979|183030899|SUPERIORITY||Wald Chi-square|2.84||||0.24|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.24
91571012|NCT05178979|183030899|SUPERIORITY||unstandardized beta|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.92|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.92
91571013|NCT05178979|183030899|SUPERIORITY||unstandardized beta|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.21|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.21
91571014|NCT00817336|183030903|SUPERIORITY_OR_OTHER||Cohen's d|0.8||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
91571015|NCT00817336|183030904|SUPERIORITY||Cohen's d|2.3||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
91571016|NCT00817336|183030905|SUPERIORITY_OR_OTHER||Cohen's d|0.41||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||.31
91571017|NCT00817336|183030906|SUPERIORITY||Cohen's d|0.41||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||.41
91571018|NCT01182181|183030930|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.6|||||TWO_SIDED|90.0|92.34|98.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.95|92.34|
91571019|NCT01182181|183030931|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.3|||||TWO_SIDED|90.0|93.14|99.57|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.57|93.14|
91571020|NCT00511797|183030932|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.49|-0.34||Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.|t-test, 1 sided|||Three null hypotheses were sequentially tested. H01: DRSP 3 mg \>= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg \< Placebo (Active is greater in decrease of score), H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo, H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.34|-1.49|<0.001
91571021|NCT00511797|183030932|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.001||95.0|-1.64|-0.55|||t-test, 1 sided|||Second null hypothesis was tested. H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo.||-0.55|-1.64|<0.001
91571022|NCT00511797|183030932|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.28|<|0.001||95.0|-2.0|-0.89|||t-test, 1 sided|||Third null hypotheses was tested. H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.89|-2.00|<0.001
91571023|NCT00511797|183030933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.74|-0.46|||t-test, 1 sided|||Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.||-0.46|-1.74|<0.001
91571024|NCT00511797|183030933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.306|<|0.001||95.0|-1.95|-0.73|||t-test, 1 sided|||||-0.73|-1.95|<0.001
91571025|NCT00511797|183030933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.317|<|0.001||95.0|-2.16|-0.9|||t-test, 1 sided|||||-0.90|-2.16|<0.001
91571026|NCT03845075|183030962|SUPERIORITY||LS Mean Difference|3.6||||0.4671|TWO_SIDED|95.0|-6.58|13.78||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||13.78|-6.58|0.4671
91571027|NCT03845075|183030962|SUPERIORITY||LS Mean Difference|10.11||||0.1808|TWO_SIDED|95.0|-5.14|25.36||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||25.36|-5.14|0.1808
91571028|NCT03845075|183030962|SUPERIORITY||LS Mean Difference|4.63||||0.4171|TWO_SIDED|95.0|-7.08|16.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||16.33|-7.08|0.4171
91571029|NCT03845075|183030962|SUPERIORITY||LS Mean Difference|5.33||||0.3116|TWO_SIDED|95.0|-5.43|16.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||16.10|-5.43|0.3116
91571030|NCT03845075|183030962|SUPERIORITY||LS Mean Difference|5.8||||0.2353|TWO_SIDED|95.0|-4.12|15.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||15.72|-4.12|0.2353
91571031|NCT03845075|183030962|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||17.48|-5.76|0.3037
91571032|NCT03845075|183030963|SUPERIORITY||LS Mean Difference|-1.31||||0.6543|TWO_SIDED|95.0|-7.33|4.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||4.72|-7.33|0.6543
91571033|NCT03845075|183030963|SUPERIORITY||LS Mean Difference|0.94||||0.7941|TWO_SIDED|95.0|-6.5|8.38||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||8.38|-6.50|0.7941
91571034|NCT03845075|183030963|SUPERIORITY||LS Mean Difference|-2.0||||0.5937|TWO_SIDED|95.0|-9.72|5.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||5.73|-9.72|0.5937
91571035|NCT03845075|183030963|SUPERIORITY||LS Mean Difference|2.56||||0.5423|TWO_SIDED|95.0|-6.11|11.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||11.23|-6.11|0.5423
91571036|NCT03845075|183030963|SUPERIORITY||LS Mean Difference|1.2||||0.7226|TWO_SIDED|95.0|-5.77|8.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||8.16|-5.77|0.7226
91571037|NCT03845075|183030963|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||10.16|-7.85|0.7912
91571038|NCT03845075|183030964|SUPERIORITY||LS Mean Difference|-1.35||||0.7023|TWO_SIDED|95.0|-8.67|5.97||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||5.97|-8.67|0.7023
91571039|NCT03845075|183030964|SUPERIORITY||LS Mean Difference|-0.48||||0.9012|TWO_SIDED|95.0|-8.58|7.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||7.61|-8.58|0.9012
91571040|NCT03845075|183030964|SUPERIORITY||LS Mean Difference|2.14||||0.6138|TWO_SIDED|95.0|-6.63|10.92||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||10.92|-6.63|0.6138
91571041|NCT03845075|183030964|SUPERIORITY||LS Mean Difference|1.23||||0.7889|TWO_SIDED|95.0|-8.26|10.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||10.72|-8.26|0.7889
91571042|NCT03845075|183030964|SUPERIORITY||LS Mean Difference|0.3||||0.9536|TWO_SIDED|95.0|-10.34|10.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||10.94|-10.34|0.9536
91571043|NCT03845075|183030964|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||12.12|-6.72|0.5551
91571044|NCT03845075|183030968|SUPERIORITY||LS Mean Difference|-2.52||||0.7782|TWO_SIDED|95.0|-21.23|16.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||16.20|-21.23|0.7782
91571045|NCT03845075|183030968|SUPERIORITY||LS Mean Difference|-7.26||||0.313|TWO_SIDED|95.0|-22.09|7.56||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||7.56|-22.09|0.3130
91571046|NCT03845075|183030968|SUPERIORITY||LS Mean Difference|-5.73||||0.4033|TWO_SIDED|95.0|-19.92|8.47||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48||8.47|-19.92|0.4033
91571047|NCT03845075|183030969|SUPERIORITY||LS Mean Difference|-7.5||||0.0325|TWO_SIDED|95.0|-14.29|-0.71||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||-0.71|-14.29|0.0325
91571048|NCT03845075|183030969|SUPERIORITY||LS Mean Difference|-0.32||||0.9394|TWO_SIDED|95.0|-9.04|8.4||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||8.40|-9.04|0.9394
91571049|NCT03845075|183030969|SUPERIORITY||LS Mean Difference|6.91||||0.0135|TWO_SIDED|95.0|1.65|12.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 28||12.18|1.65|0.0135
91571050|NCT03845075|183030970|SUPERIORITY||LS Mean Difference|-4.17||||0.1048|TWO_SIDED|95.0|-9.31|0.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed.||0.98|-9.31|0.1048
91571051|NCT03845075|183030970|SUPERIORITY||LS Mean Difference|-0.99||||0.7189|TWO_SIDED|95.0|-6.75|4.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT observed.||4.77|-6.75|0.7189
91571052|NCT03845075|183030970|SUPERIORITY||LS Mean Difference|3.09||||0.1053|TWO_SIDED|95.0|-0.73|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT observed.||6.91|-0.73|0.1053
91571053|NCT03845075|183030971|SUPERIORITY||LS Mean Difference|-3.12||||0.0033|TWO_SIDED|95.0|-5.02|-1.21||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||-1.21|-5.02|0.0033
91571054|NCT03845075|183030971|SUPERIORITY||LS Mean Difference|0.58||||0.6663|TWO_SIDED|95.0|-2.24|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||3.41|-2.24|0.6663
91571055|NCT03845075|183030971|SUPERIORITY||LS Mean Difference|3.59||||0.0058|TWO_SIDED|95.0|1.21|5.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||5.98|1.21|0.0058
91571056|NCT03845075|183030972|SUPERIORITY||LS Mean Difference|-3.02||||0.0713|TWO_SIDED|95.0|-6.34|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||0.30|-6.34|0.0713
91571057|NCT03845075|183030972|SUPERIORITY||LS Mean Difference|-2.48||||0.1457|TWO_SIDED|95.0|-5.92|0.96||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.96|-5.92|0.1457
91571058|NCT03845075|183030972|SUPERIORITY||LS Mean Difference|0.85||||0.1837|TWO_SIDED|95.0|-0.45|2.15||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||2.15|-0.45|0.1837
91571059|NCT03845075|183030973|SUPERIORITY||LS Mean Difference|-0.05||||0.7926|TWO_SIDED|95.0|-0.42|0.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT LOCF||0.33|-0.42|0.7926
91571060|NCT03845075|183030973|SUPERIORITY||LS Mean Difference|-0.27||||0.2124|TWO_SIDED|95.0|-0.72|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.17|-0.72|0.2124
91571061|NCT03845075|183030973|SUPERIORITY||LS Mean Difference|-0.14||||0.6084|TWO_SIDED|95.0|-0.72|0.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||0.43|-0.72|0.6084
91571062|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|16.0||||0.0905|TWO_SIDED|95.0|-2.85|34.85||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to week 24; mITT observed. (Like to eat something fatty)||34.85|-2.85|0.0905
91571063|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|6.65||||0.6285|TWO_SIDED|95.0|-22.05|35.36||P-value from ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Like some meat/fish)||35.36|-22.05|0.6285
91571064|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-6.81||||0.5884|TWO_SIDED|95.0|-33.05|19.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something salty).||19.43|-33.05|0.5884
91571065|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|2.98||||0.8533|TWO_SIDED|95.0|-30.73|36.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something sweet).||36.68|-30.73|0.8533
91571066|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-17.33||||0.1529|TWO_SIDED|95.0|-41.87|7.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like to eat something fatty).||7.20|-41.87|0.1529
91571067|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-11.75||||0.3399|TWO_SIDED|95.0|-37.15|13.65||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like some meat/fish).||13.65|-37.15|0.3399
91571068|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-23.95||||0.0673|TWO_SIDED|95.0|-49.84|1.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something salty).||1.93|-49.84|0.0673
91571069|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-22.6||||0.1657|TWO_SIDED|95.0|-55.65|10.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something sweet).||10.46|-55.65|0.1657
91571070|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-30.18||||0.0108|TWO_SIDED|95.0|-52.31|-8.06||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like to eat something fatty).||-8.06|-52.31|0.0108
91571071|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-14.79||||0.171|TWO_SIDED|95.0|-36.71|7.13||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like some meat/fish).||7.13|-36.71|0.1710
91571072|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-19.86||||0.0083|TWO_SIDED|95.0|-33.8|-5.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something salty).||-5.93|-33.80|0.0083
91571073|NCT03845075|183030974|SUPERIORITY||LS Mean Difference|-22.98||||0.0631|TWO_SIDED|95.0|-47.39|1.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something sweet).||1.43|-47.39|0.0631
91571074|NCT03845075|183030975|SUPERIORITY||LS Mean Difference|-2.56||||0.8082|TWO_SIDED|95.0|-24.65|19.53||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed.||19.53|-24.65|0.8082
91571075|NCT03845075|183030975|SUPERIORITY||LS Mean Difference|-1.42||||0.9034|TWO_SIDED|95.0|-25.94|23.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||23.10|-25.94|0.9034
91571076|NCT03845075|183030975|SUPERIORITY||LS Mean Difference|-7.0||||0.4658|TWO_SIDED|95.0|-26.93|12.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||12.93|-26.93|0.4658
91571077|NCT03845075|183030976|SUPERIORITY||LS Mean Difference|-5.68||||0.0537|TWO_SIDED|95.0|-11.46|0.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT LOCF.||0.10|-11.46|0.0537
91571078|NCT03845075|183030976|SUPERIORITY||LS Mean Difference|-2.69||||0.3772|TWO_SIDED|95.0|-8.98|3.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||3.61|-8.98|0.3772
91571079|NCT03845075|183030976|SUPERIORITY||LS Mean Difference|3.03||||0.1171|TWO_SIDED|95.0|-0.85|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||6.91|-0.85|0.1171
91571080|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|-0.05||||0.8623|TWO_SIDED|95.0|-0.59|0.5||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in total cholesterol)||0.50|-0.59|0.8623
91571081|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.03||||0.8327|TWO_SIDED|95.0|-0.25|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in HDL cholesterol)||0.30|-0.25|0.8327
91571082|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|-0.06||||0.808|TWO_SIDED|95.0|-0.53|0.42||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in LDL cholesterol)||0.42|-0.53|0.8080
91571083|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.22||||0.5791|TWO_SIDED|95.0|-0.62|1.07|||ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in triglycerides)||1.07|-0.62|0.5791
91571084|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.03||||0.9337|TWO_SIDED|95.0|-0.71|0.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in cholesterol)||0.77|-0.71|0.9337
91571085|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.01||||0.9305|TWO_SIDED|95.0|-0.21|0.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in HDL cholesterol)||0.23|-0.21|0.9305
91571086|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.09||||0.691|TWO_SIDED|95.0|-0.4|0.59||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in LDL cholesterol)||0.59|-0.40|0.6910
91571087|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.35||||0.2688|TWO_SIDED|95.0|-0.3|1.01||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in triglycerides)||1.01|-0.30|0.2688
91571088|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.06||||0.8262|TWO_SIDED|95.0|-0.54|0.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in cholesterol)||0.67|-0.54|0.8262
91571089|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|-0.02||||0.8293|TWO_SIDED|95.0|-0.2|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in HDL cholesterol)||0.17|-0.20|0.8293
91571090|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.11||||0.5486|TWO_SIDED|95.0|-0.27|0.49||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in LDL cholesterol)||0.49|-0.27|0.5486
91571091|NCT03845075|183030977|SUPERIORITY||LS Mean Difference|0.24||||0.3226|TWO_SIDED|95.0|-0.26|0.75||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in triglycerides)||0.75|-0.26|0.3226
91571092|NCT03845075|183030978|SUPERIORITY||LS Mean Difference|0.59||||0.842|TWO_SIDED|95.0|-5.55|6.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Physical component score)||6.73|-5.55|0.8420
91571093|NCT03845075|183030978|SUPERIORITY||LS Mean Difference|-1.74||||0.6693|TWO_SIDED|95.0|-10.15|6.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Mental component score)||6.67|-10.15|0.6693
91571094|NCT03845075|183030978|SUPERIORITY||LS Mean Difference|-1.83||||0.5444|TWO_SIDED|95.0|-8.12|4.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Physical component score)||4.46|-8.12|0.5444
91571095|NCT03845075|183030978|SUPERIORITY||LS Mean Difference|-1.85||||0.5595|TWO_SIDED|95.0|-8.47|4.76||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Mental component score)||4.76|-8.47|0.5595
91571096|NCT03845075|183030978|SUPERIORITY||LS Mean Difference|-2.07||||0.4331|TWO_SIDED|95.0|-7.54|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Physical component score)||3.41|-7.54|0.4331
91571097|NCT03845075|183030978|SUPERIORITY||LS Mean Difference|-1.44||||0.6427|TWO_SIDED|95.0|-7.9|5.03||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Mental component score)||5.03|-7.90|0.6427
91571098|NCT03845075|183030980|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in systolic blood pressure)||17.48|-5.76|0.3037
91571099|NCT03845075|183030980|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in diastolic blood pressure)||10.16|-7.85|0.7912
91571100|NCT03845075|183030980|SUPERIORITY||LS Mean Difference|10.29||||0.1773|TWO_SIDED|95.0|-5.25|25.83||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in systolic blood pressure)||25.83|-5.25|0.1773
91571101|NCT03845075|183030980|SUPERIORITY||LS Mean Difference|1.32||||0.798|TWO_SIDED|95.0|-9.55|12.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in diastolic blood pressure)||12.20|-9.55|0.7980
91571102|NCT03845075|183030980|SUPERIORITY||LS Mean Difference|7.77||||0.158|TWO_SIDED|95.0|-3.4|18.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in systolic blood pressure)||18.94|-3.40|0.1580
91571103|NCT03845075|183030980|SUPERIORITY||LS Mean Difference|1.64||||0.7021|TWO_SIDED|95.0|-7.36|10.64||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in diastolic blood pressure)||10.64|-7.36|0.7021
91571104|NCT03845075|183030981|SUPERIORITY||LS Mean Difference|1.5||||0.8728|TWO_SIDED|95.0|-18.17|21.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in systolic blood pressure mean)||21.18|-18.17|0.8728
91571105|NCT03845075|183030981|SUPERIORITY||LS Mean Difference|2.46||||0.5714|TWO_SIDED|95.0|-6.61|11.54||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in diastolic blood pressure mean)||11.54|-6.61|0.5714
91571106|NCT03845075|183030981|SUPERIORITY||LS Mean Difference|-10.15||||0.2322|TWO_SIDED|95.0|-27.51|7.22||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in systolic blood pressure mean)||7.22|-27.51|0.2322
91571107|NCT03845075|183030981|SUPERIORITY||LS Mean Difference|-3.46||||0.4321|TWO_SIDED|95.0|-12.61|5.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in diastolic blood pressure mean)||5.68|-12.61|0.4321
91571108|NCT03845075|183030984|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in heart rate)||12.12|-6.72|0.5551
91571109|NCT03845075|183030984|SUPERIORITY||LS Mean Difference|-2.13||||0.7256|TWO_SIDED|95.0|-14.88|10.63||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in heart rate)||10.63|-14.88|0.7256
91571110|NCT03845075|183030984|SUPERIORITY||LS Mean Difference|-3.29||||0.4822|TWO_SIDED|95.0|-13.05|6.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in heart rate)||6.48|-13.05|0.4822
91571111|NCT01586975|183031008|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED|||||p-value is not adjusted, and no a priori threshold was used|Kruskal-Wallis|||Kruskal-Wallis non-parametric ANOVA test||||0.0742
91571112|NCT02138253|183031009|SUPERIORITY|For the primary efficacy analysis based on the Month 24 biopsy, subjects with a missing Month 24 biopsy had their Ishak fibrosis score imputed. Imputation of missing Ishak fibrosis scores was conducted using multiple imputation (MI). Results were imputed based on age, gender, baseline Ishak fibrosis score, and the Month 12 Ishak fibrosis score.|Risk Difference (RD)|2.9||||0.73|TWO_SIDED|95.0|-20.5|26.4||Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).|Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||26.4|-20.5|0.73
91571113|NCT02138253|183031010|SUPERIORITY||Risk Difference (RD)|4.4||||0.658|TWO_SIDED|95.0|-20.0|28.9|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||28.9|-20.0|0.658
91571114|NCT02138253|183031011|SUPERIORITY||Risk Difference (RD)|-7.9||||0.421|TWO_SIDED|95.0|-28.8|13.1|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||13.1|-28.8|0.421
91571115|NCT03802617|183031056|OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.38||0.77|TWO_SIDED|95.0|-0.85|0.63|||MMRM|||||0.63|-0.85|0.770
91571116|NCT03802617|183031056|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.038|TWO_SIDED|95.0|-1.55|-0.04|||MMRM|||||-0.04|-1.55|0.038
91571117|NCT03802617|183031056|OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.38||0.041|TWO_SIDED|95.0|-1.54|-0.03|||MMRM|||||-0.03|-1.54|0.041
91571118|NCT00267098|183031071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.729||||0.999|TWO_SIDED|95.0|0.592|0.889||BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.||0.889|0.592|0.9990
91571119|NCT00267098|183031072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.865|TWO_SIDED|95.0|0.632|1.142||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.||1.142|0.632|0.865
91571120|NCT00267098|183031073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.781||||0.9785|TWO_SIDED|95.0|0.615|0.991||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.||0.991|0.615|0.9785
91571121|NCT00267098|183031074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.9886|TWO_SIDED|95.0|0.558|0.866||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing."||0.866|0.558|0.9886
91571122|NCT00267098|183031075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.9904|TWO_SIDED|95.0|0.522|0.947||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.||0.947|0.522|0.9904
91571123|NCT00267098|183031076|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-1.8||||0.637||||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Difference in Average Ranks|The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.|The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.||||0.637
91571124|NCT00267098|183031077|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.012||||0.591|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.591
91571125|NCT00267098|183031077|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.126||||0.986|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.986
91571126|NCT00267098|183031077|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.039||||0.726|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.726
91571127|NCT00267098|183031077|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.035||||0.701|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.701
91571128|NCT00267098|183031078|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.002||||0.534|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.534
91571129|NCT00267098|183031078|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.026||||0.825|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.825
91571130|NCT00267098|183031078|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.01||||0.651|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote that the BiV arm had better outcomes over time than the RV arm.|Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.651
91571131|NCT00267098|183031078|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-0.006||||0.425|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.425
91571132|NCT00267098|183031082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.9976|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing."||||0.9976
91571133|NCT00267098|183031083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.9641|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing."||||0.9641
91571134|NCT00267098|183031084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.8416|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing."||||0.8416
91571135|NCT00267098|183031085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing."||||0.7270
91571136|NCT00267098|183031086|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.334|||||TWO_SIDED|95.0|1.886|4.815||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 6 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing."||4.815|1.886|
91571137|NCT00267098|183031087|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.232|||||TWO_SIDED|95.0|1.618|4.839||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 12 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.||4.839|1.618|
91571138|NCT00267098|183031088|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|2.24|||||TWO_SIDED|95.0|0.419|4.066||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF at 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.||4.066|0.419|
91571139|NCT00267098|183031089|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.623|||||TWO_SIDED|95.0|1.623|5.604||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 24 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.||5.604|1.623|
91571140|NCT00267098|183031090|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.204|||||TWO_SIDED|95.0|-10.12|-4.214||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing."||-4.214|-10.12|
91571141|NCT00267098|183031091|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.255|||||TWO_SIDED|95.0|-10.59|-3.829||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.||-3.829|-10.590|
91571142|NCT00267098|183031092|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.242|||||TWO_SIDED|95.0|-11.86|-4.574||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.||-4.574|-11.860|
91571143|NCT00267098|183031093|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.268|||||TWO_SIDED|95.0|-11.69|-2.846||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.||-2.846|-11.690|
91571144|NCT00267098|183031094|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.858|||||TWO_SIDED|95.0|-9.085|-2.562||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.||-2.562|-9.085|
91571145|NCT00267098|183031095|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.807|||||TWO_SIDED|95.0|-9.467|-2.038||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing."||-2.038|-9.467|
91571146|NCT00267098|183031096|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.844|||||TWO_SIDED|95.0|-12.91|-4.681||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing."||-4.681|-12.910|
91571147|NCT00267098|183031097|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-6.615|||||TWO_SIDED|95.0|-11.37|-1.736||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.||-1.736|-11.370|
91571148|NCT00267098|183031098|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-3.894|||||TWO_SIDED|95.0|-12.13|3.953||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||3.953|-12.130|
91571149|NCT00267098|183031099|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-10.16|||||TWO_SIDED|95.0|-19.33|-0.857||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||-0.857|-19.330|
91571150|NCT00267098|183031100|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.316|||||TWO_SIDED|95.0|-18.19|1.623||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||1.623|-18.190|
91571151|NCT00267098|183031101|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-11.08|||||TWO_SIDED|95.0|-21.11|-0.956||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||-0.956|-21.110|
91571152|NCT00267098|183031102|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.235|-0.014||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.014|-0.235|
91571153|NCT00267098|183031103|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.162|||||TWO_SIDED|95.0|-0.287|-0.035||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.035|-0.287|
91571154|NCT00267098|183031104|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.163|||||TWO_SIDED|95.0|-0.293|-0.03||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.030|-0.293|
91571155|NCT00267098|183031105|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.245|||||TWO_SIDED|95.0|-0.39|-0.097||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.097|-0.390|
91571156|NCT00267098|183031106|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.066|||||TWO_SIDED|95.0|-0.185|0.055||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.055|-0.185|
91571157|NCT00267098|183031107|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.104|||||TWO_SIDED|95.0|-0.236|0.029||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.029|-0.236|
91571158|NCT00267098|183031108|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.204|0.087||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.087|-0.204|
91571159|NCT00267098|183031109|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.18|||||TWO_SIDED|95.0|-0.339|-0.018||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.||-0.018|-0.339|
91571160|NCT00267098|183031110|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.683|||||TWO_SIDED|95.0|-2.828|1.506||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||1.506|-2.828|
91571161|NCT00267098|183031111|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.564|||||TWO_SIDED|95.0|-2.843|1.773||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||1.773|-2.843|
91571162|NCT00267098|183031112|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.016|||||TWO_SIDED|95.0|-2.379|2.425||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||2.425|-2.379|
91571163|NCT00267098|183031113|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.653|||||TWO_SIDED|95.0|-3.337|2.046||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||2.046|-3.337|
91571164|NCT00267098|183031114|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.08|||||TWO_SIDED|95.0|-0.031|0.195||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.195|-0.031|
91571165|NCT00267098|183031115|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.086|||||TWO_SIDED|95.0|-0.022|0.198||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.198|-0.022|
91571166|NCT00267098|183031116|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.081|||||TWO_SIDED|95.0|-0.218|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.058|-0.218|
91571167|NCT00267098|183031117|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.047|||||TWO_SIDED|95.0|-0.095|0.192||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.192|-0.095|
91571168|NCT00267098|183031118|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|29.3|||||TWO_SIDED|95.0|10.04|48.64||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.||48.640|10.040|
91571169|NCT00267098|183031119|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|21.83|||||TWO_SIDED|95.0|2.841|40.87||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.||40.870|2.841|
91571170|NCT00267098|183031120|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|26.53|||||TWO_SIDED|95.0|6.247|47.19||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.||47.190|6.247|
91571171|NCT00267098|183031121|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|23.32|||||TWO_SIDED|95.0|1.999|44.53||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.||44.530|1.999|
91571172|NCT00267098|183031122|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.047|||||TWO_SIDED|95.0|-0.18|0.089||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.089|-0.180|
91571173|NCT00267098|183031123|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.117|||||TWO_SIDED|95.0|-0.287|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.058|-0.287|
91571174|NCT00267098|183031124|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.041|||||TWO_SIDED|95.0|-0.136|0.22||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.220|-0.136|
91571175|NCT00267098|183031125|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.11|||||TWO_SIDED|95.0|-0.085|0.311||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.311|-0.085|
91571176|NCT00267098|183031126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1841||||0.9985||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9985
91571177|NCT00267098|183031127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2503||||0.9999||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9999
91571178|NCT00267098|183031128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1978||||0.9978||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9978
91571179|NCT00267098|183031129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2069||||0.9983||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9983
91571180|NCT00267098|183031131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.189|TWO_SIDED|95.0|0.78|2.01||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.||2.01|0.78|0.189
91571181|NCT04211389|183031135|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.17|13.7||Stratification by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||13.70|3.17|<0.0001
91571182|NCT04211389|183031136|SUPERIORITY||Hazard Ratio (HR)|4.207|||<|0.0001|TWO_SIDED|95.0|3.029|5.844|||Log Rank|Unstratified log-rank test|HR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to Achieve PASI-50||5.844|3.029|<0.0001
91571183|NCT04211389|183031137|SUPERIORITY||Odds Ratio (OR)|10.42|||<|0.0001|TWO_SIDED|95.0|4.49|24.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||24.19|4.49|<0.0001
91571184|NCT04211389|183031138|SUPERIORITY||Odds Ratio (OR)|8.51||||0.0002|TWO_SIDED|95.0|2.45|28.86|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||28.86|2.45|0.0002
91571185|NCT04211389|183031139|SUPERIORITY||Odds Ratio (OR)|11.18||||0.0004|TWO_SIDED|95.0|2.33|53.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||53.68|2.33|0.0004
91571186|NCT04211389|183031140|SUPERIORITY||Odds Ratio (OR)|15.27||||0.0002|TWO_SIDED|95.0|3.1|75.35|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||75.35|3.10|0.0002
91571187|NCT04211389|183031141|SUPERIORITY|WI-NRS Success at Week 2 Odds Ratio|Odds Ratio (OR)|2.56||||0.0026|TWO_SIDED|95.0|1.43|4.58|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||4.58|1.43|0.0026
91571188|NCT04211389|183031141|SUPERIORITY|WI-NRS Success at Week 4 Odds Ratio|Odds Ratio (OR)|4.93|||<|0.0001|TWO_SIDED|95.0|2.65|9.18|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||9.18|2.65|<0.0001
91571189|NCT04211389|183031141|SUPERIORITY|WI-NRS Success at Week 8 Odds Ratio|Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.07|6.23|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||6.23|2.07|<0.0001
91571190|NCT04211389|183031142|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.0001|TWO_SIDED|95.0|-31.9|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 4||-20.0|-31.9|<0.0001
91571191|NCT04211389|183031142|SUPERIORITY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-33.2|-19.7|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 8||-19.7|-33.2|<0.0001
91571192|NCT01182207|183031152|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.74|||||TWO_SIDED|90.0|86.82|107.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.79|86.82|
91571193|NCT01182207|183031153|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.16|||||TWO_SIDED|90.0|101.1|105.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.27|101.10|
91571194|NCT01182207|183031154|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.72|||||TWO_SIDED|90.0|100.67|104.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.80|100.67|
91571195|NCT01182207|183031155|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|89.45|106.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.50|89.45|
91571196|NCT01182207|183031156|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.88|||||TWO_SIDED|90.0|95.62|102.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.25|95.62|
91571197|NCT01182207|183031157|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.2|||||TWO_SIDED|90.0|95.36|101.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.12|95.36|
91571198|NCT01427738|183031158|SUPERIORITY_OR_OTHER||Difference in proportion with clinical e|0.044|||||TWO_SIDED|95.1|-0.077|0.166||||||Repeated confidence intervals (RCIs) were used to control type I error.A interim analysis was conducted by a 99.7% CI. The final analyses use a 95.1% CI, based on the Lan-DeMets error-spending function corresponding to the O'Brien-Fleming boundary.76% of 100 participant in arm GV had cure or improvement of OC after 14 days of treatment, and 71.6% of 102 in arm nystatin had cure or improvement of OC. Difference in clinical efficacy rates between GV and nystatin 95.1% CI is 0.044 (-0.077, 0.166).||0.166|-0.077|
91571199|NCT00727506|183031181|SUPERIORITY_OR_OTHER|||||||0.148||95.0||||P-value is from an approximate normal test for the 6 month time point.|z-test|||||||0.148
91571200|NCT00727506|183031181|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value is an approximate normal test for the six month time point.|z-test|||||||0.008
91571201|NCT00727506|183031183|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
91571202|NCT00727506|183031183|SUPERIORITY_OR_OTHER|||||||0.1954||95.0|||||Fisher Exact|||||||0.1954
91571203|NCT00727506|183031184|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.78||||0.032|TWO_SIDED|95.0|1.088|2.912|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline Karnofsky Performance Scale (KPS) score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.912|1.088|0.0320
91571204|NCT00727506|183031184|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.392||||0.2044|TWO_SIDED|95.0|0.841|2.301|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline KPS score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.301|0.841|0.2044
91571205|NCT01214421|183031221|SUPERIORITY||Ratio of geometric means (final values)|0.99||||0.358|TWO_SIDED|95.0|0.96|1.02|||Mixed Models Analysis||||Derived from the least squares (LS) mean difference between the treatment groups at each visit using MMRM model with factors of treatment, visit, region, baseline, baseline hypertensive status, baseline renal volume status, baseline creatinine clearance status, interaction of treatment and visit, and interaction of baseline and visit.|1.02|0.96|0.358
91571206|NCT01214421|183031222|SUPERIORITY||LS mean difference (final values)|3.15||||0.0003|TWO_SIDED|95.0|1.462|4.836|||Mixed Models Analysis||||Derived from MMRM analysis with fixed factors of treatment, visit, treatment visit interaction, hypertensive status, renal volume status and creatinine clearance status at baseline, region, baseline value, and baseline visit interaction as covariates, and with a heterogeneous toeplitz variance covariance matrix.|4.836|1.462|0.0003
91571207|NCT01214421|183031223|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|1.011||||0.0462|TWO_SIDED|95.0|1.0|1.023|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|1.023|1.000|0.0462
91571208|NCT01214421|183031224|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|-0.113||||0.7259|TWO_SIDED|95.0|-0.746|0.52|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|0.520|-0.746|0.7259
91571209|NCT01214421|183031225|SUPERIORITY||Ratio of geometric means (final values)|0.992||||0.108|TWO_SIDED|95.0|0.982|1.002|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|1.002|0.982|0.1080
91571210|NCT01214421|183031226|SUPERIORITY||Ratio of geometric means (final values)|0.361||||0.2265|TWO_SIDED|95.0|-0.224|0.946|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|0.946|-0.224|0.2265
91571211|NCT04590404|183031242|SUPERIORITY||Odds Ratio (OR)|1.18||||0.461|TWO_SIDED|95.0|0.76|1.82|||Regression, Logistic|Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \& plan to quit after discharge||The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).||1.82|0.76|0.461
91571212|NCT04590404|183031243|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.64|1.54||Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \& plan to quit after discharge|Regression, Logistic|||The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 12 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).||1.54|0.64|0.99
91571213|NCT03912532|183031246|OTHER|The Multiple Comparison Procedure-Modelling (MCP-Mod) is a 2-stage procedure in which dose-response models are selected at the design stage. These candidate models are used for both dose-response testing (MCP step) and estimation (Mod step). The dose-response testing is performed using a multiple comparison method to account for the multiplicity issue associated with the multiple candidate models. Missing responses were imputed using multiple imputation under the assumption of missing at random.||||||0.5534|||||||Multiple comparison procedure step|||||||0.5534
91571214|NCT03522389|183031266|SUPERIORITY|||||||0.003|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.003
91571215|NCT03522389|183031266|SUPERIORITY||||||<|0.001|||||||ANOVA|||1-month follow up - Baseline (T3-T1)||||<0.001
91571216|NCT03522389|183031266|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91571217|NCT03522389|183031266|SUPERIORITY|||||||0.006|||||||ANOVA|||Within group comparison||||0.006
91571218|NCT03522389|183031266|SUPERIORITY|||||||0.793|||||||ANOVA|||Within group comparison||||0.793
91571219|NCT03522389|183031267|SUPERIORITY||||||<|0.001|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||<0.001
91571220|NCT03522389|183031267|SUPERIORITY|||||||0.039|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.039
91571221|NCT03522389|183031267|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91571222|NCT03522389|183031267|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
91571223|NCT03522389|183031267|SUPERIORITY|||||||0.117|||||||ANOVA|||Within group comparison||||0.117
91571224|NCT03522389|183031268|SUPERIORITY|||||||0.924|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.924
91571225|NCT03522389|183031268|SUPERIORITY|||||||0.855|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.855
91571226|NCT03522389|183031268|SUPERIORITY|||||||0.937|||||||ANOVA|||Within group comparison||||0.937
91571227|NCT03522389|183031268|SUPERIORITY|||||||0.97|||||||ANOVA|||Within group comparison||||0.970
91571228|NCT03522389|183031268|SUPERIORITY|||||||0.242|||||||ANOVA|||Within group comparison||||0.242
91571229|NCT03522389|183031269|SUPERIORITY|||||||0.161|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.161
91571230|NCT03522389|183031269|SUPERIORITY|||||||0.161|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.161
91571231|NCT03522389|183031269|SUPERIORITY|||||||0.076|||||||ANOVA|||Within group comparison||||0.076
91571232|NCT03522389|183031269|SUPERIORITY|||||||0.211|||||||ANOVA|||Within group comparison||||0.211
91571233|NCT03522389|183031269|SUPERIORITY|||||||0.573|||||||ANOVA|||Within group comparison||||0.573
91571234|NCT03522389|183031270|SUPERIORITY|||||||0.445|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.445
91571235|NCT03522389|183031270|SUPERIORITY|||||||0.046|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.046
91571236|NCT03522389|183031270|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
91571237|NCT03522389|183031270|SUPERIORITY|||||||0.028|||||||ANOVA|||Within group comparison||||0.028
91571238|NCT03522389|183031270|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
91571239|NCT03459612|183031271|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in Least Square (LS) means \< 4.4.|Difference in LS Means|0.98|||<|0.0001|TWO_SIDED|95.0|-0.43|2.39|||Mixed Models Analysis|||||2.39|-0.43|<0.0001
91571240|NCT03459612|183031271|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|0.32|3.2|||Mixed Models Analysis|||||3.20|0.32|<0.0001
91571241|NCT03459612|183031271|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|4.98|||<|0.0001|TWO_SIDED|95.0|3.58|6.38|||Mixed Models Analysis|||||6.38|3.58|<0.0001
91571242|NCT03459612|183031272|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.12|||<|0.0001|TWO_SIDED|95.0|-1.28|1.04|||Mixed Models Analysis|||||1.04|-1.28|<0.0001
91571243|NCT03459612|183031272|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-1.51|0.88|||Mixed Models Analysis|||||0.88|-1.51|<0.0001
91571244|NCT03459612|183031272|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.31|||<|0.0001|TWO_SIDED|95.0|3.17|5.45|||Mixed Models Analysis|||||5.45|3.17|<0.0001
91571245|NCT03459612|183031273|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Differnce in LS Means|-0.97|||<|0.0001|TWO_SIDED|95.0|-2.3|0.36|||Mixed Models Analysis|||||0.36|-2.30|<0.0001
91571246|NCT03459612|183031273|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-1.04|||<|0.0001|TWO_SIDED|95.0|-2.4|0.32|||Mixed Models Analysis|||||0.32|-2.40|<0.0001
91571247|NCT03459612|183031273|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.05|||<|0.0001|TWO_SIDED|95.0|2.73|5.38|||Mixed Models Analysis|||||5.38|2.73|<0.0001
91571248|NCT03459612|183031274|SUPERIORITY||Differences of Least Square Mean|0.28|||||TWO_SIDED|95.0|-0.15|0.7||||||||0.70|-0.15|
91571249|NCT03459612|183031274|SUPERIORITY||Difference of Least Square Means|0.66|||||TWO_SIDED|95.0|0.22|1.1||||||||1.10|0.22|
91571250|NCT03459612|183031274|SUPERIORITY||Difference of Least Square Means|0.81|||||TWO_SIDED|95.0|0.39|1.24||||||||1.24|0.39|
91571251|NCT03459612|183031275|SUPERIORITY||Difference of Least Square Means|0.48|||||TWO_SIDED|95.0|0.0|0.96||||||||0.96|0.00|
91571252|NCT03459612|183031275|SUPERIORITY||Differnce of Least Square Means|0.34|||||TWO_SIDED|95.0|-0.14|0.82||||||||0.82|-0.14|
91571253|NCT03459612|183031275|SUPERIORITY||Difference of Least Square Means|1.29|||||TWO_SIDED|95.0|0.81|1.78||||||||1.78|0.81|
91571254|NCT03459612|183031276|SUPERIORITY||Difference of Least Square Means|-0.58|||||TWO_SIDED|95.0|-1.1|-0.06||||||||-0.06|-1.10|
91571255|NCT03459612|183031276|SUPERIORITY||Difference of Least Square Means|-0.4|||||TWO_SIDED|95.0|-0.89|0.09||||||||0.09|-0.89|
91571256|NCT03459612|183031276|SUPERIORITY||Difference of Least Square Means|0.44|||||TWO_SIDED|95.0|-0.09|0.96||||||||0.96|-0.09|
91571257|NCT03459612|183031277|SUPERIORITY||Difference in Least Square Means|0.0|||||TWO_SIDED|95.0|-1.61|1.62||||||||1.62|-1.61|
91571258|NCT03459612|183031277|SUPERIORITY||Difference in Lease Square Means|-0.74|||||TWO_SIDED|95.0|-2.49|1.01||||||||1.01|-2.49|
91571259|NCT03459612|183031277|SUPERIORITY||Difference in Least Square Means|-0.72|||||TWO_SIDED|95.0|-2.32|0.89||||||||0.89|-2.32|
91571260|NCT03459612|183031278|SUPERIORITY||Difference of Least Square Means|-1.79|||||TWO_SIDED|95.0|-3.52|-0.06||||||||-0.06|-3.52|
91571261|NCT03459612|183031278|SUPERIORITY||Difference in Least Square Means|-0.29|||||TWO_SIDED|95.0|-2.0|1.42||||||||1.42|-2.00|
91571262|NCT03459612|183031278|SUPERIORITY||Difference in Least Square Means|-3.81|||||TWO_SIDED|95.0|-5.53|-2.08||||||||-2.08|-5.53|
91571263|NCT03459612|183031279|SUPERIORITY||Difference of Least Square Means|-0.28|||||TWO_SIDED|95.0|-1.71|1.15||||||||1.15|-1.71|
91571264|NCT03459612|183031279|SUPERIORITY||Difference of Least Square Means|-0.31|||||TWO_SIDED|95.0|-1.71|1.08||||||||1.08|-1.71|
91571265|NCT03459612|183031279|SUPERIORITY||Difference of Least Square Means|-2.7|||||TWO_SIDED|95.0|-4.13|-1.27||||||||-1.27|-4.13|
91571266|NCT03459612|183031280|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.3||0.6875|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.6875
91571267|NCT03459612|183031280|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.27||0.375|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.3750
91571268|NCT03459612|183031280|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|1.0||0.0115|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0115
91571269|NCT03459612|183031281|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.42||0.1563|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1563
91571270|NCT03459612|183031281|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.44||0.5938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5938
91571271|NCT03459612|183031281|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|0.54||0.0938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0938
91571272|NCT03459612|183031282|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.56||0.125|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1250
91571273|NCT03459612|183031282|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.94||0.959|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9590
91571274|NCT03459612|183031282|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_DEVIATION|1.76||0.0097|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0097
91571275|NCT02242643|183031299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|Seroconversion rate (SCR) Difference (%)|-6.32|||||TWO_SIDED|95.0|-10.34|-2.27|||||For A/California/7/2009 (H1N1) vaccine strain.|||-2.27|-10.34|
91571276|NCT02242643|183031299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-6.74|||||TWO_SIDED|95.0|-10.68|-2.8|||||For A/Texas/50/2012 (H3N2) vaccine strain|||-2.80|-10.68|
91571277|NCT02242643|183031299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-16.38|||||TWO_SIDED|95.0|-20.68|-12.02|||||For B/Massachusetts/2/2012 (Yamagata) vaccine strain|||-12.02|-20.68|
91571278|NCT02242643|183031299|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-11.75|||||TWO_SIDED|95.0|-15.28|-8.21|||||For B/Brisbane/60/2008 (Victoria) vaccine strain.|||-8.21|-15.28|
91571279|NCT02242643|183031300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.95|0.77|
91571280|NCT02242643|183031300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.94|0.77|
91571281|NCT02242643|183031300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.65|||||TWO_SIDED|95.0|0.59|0.71|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.71|0.59|
91571282|NCT02242643|183031300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.62|||||TWO_SIDED|95.0|0.56|0.69|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.69|0.56|
91571283|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.008|||||TWO_SIDED|95.0|0.258|3.94|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]||3.940|0.258|
91571284|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.497|2.177|||||"Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]||2.177|0.497|
91571285|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.084|||||TWO_SIDED|95.0|0.317|3.71|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||3.710|0.317|
91571286|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.212|||||TWO_SIDED|95.0|0.536|2.74|||||"Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]||2.740|0.536|
91571287|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.091|||||TWO_SIDED|95.0|0.247|4.827|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]||4.827|0.247|
91571288|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.137|||||TWO_SIDED|95.0|0.461|2.801|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||2.801|0.461|
91571289|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.409|||||TWO_SIDED|95.0|0.493|4.03|||||"Risk Ratio of hepatic impairment present to absent"|Subgroup analyses of hepatic impairment||4.030|0.493|
91571290|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.096|||||TWO_SIDED|95.0|0.301|3.994|||||"Risk Ratio of past medical history - Hepatitis or hepatic disease present to absent"|Subgroup analyses of past medical history - Hepatitis or hepatic disease||3.994|0.301|
91571291|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.409|||||TWO_SIDED|95.0|0.493|4.03|||||"Risk Ratio of present medical history - Hepatitis or hepatic disease present to absent"|Subgroup analyses of present medical history - Hepatitis or hepatic disease||4.030|0.493|
91571292|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|2.954|||||TWO_SIDED|95.0|1.172|7.445|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||7.445|1.172|
91571293|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.152|||||TWO_SIDED|95.0|0.299|4.432|||||"Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|Subgroup analyses of ECOG PS before the start of this drug||4.432|0.299|
91571294|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|0.873|||||TWO_SIDED|95.0|0.113|6.743|||||"Risk Ratio of ECOG PS before the start of this drug not performed to 1"|Subgroup analyses of ECOG PS before the start of this drug||6.743|0.113|
91571295|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.158|||||TWO_SIDED|95.0|0.545|2.461|||||"Risk Ratio of AST and ALT levels immediately before the start of this drug either \> 1.5 × the institutional upper limit normal range (IULN) to ≤ 1.5 × IULN"|Subgroup analyses of AST and ALT levels immediately before the start of this drug||2.461|0.545|
91571296|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|0.59|||||TWO_SIDED|95.0|0.28|1.244|||||"Risk Ratio of γ-GTP level immediately before the start of this drug \> 50 IU/L to ≤ 50 IU/L"|Subgroup analyses of γ-GTP level immediately before the start of this drug||1.244|0.280|
91571297|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|0.267|||||TWO_SIDED|95.0|0.038|1.862|||||"Risk Ratio of γ-GTP level immediately before the start of this drug not performed to ≤ 50 IU/L"|Subgroup analyses of γ-GTP level immediately before the start of this drug||1.862|0.038|
91571298|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|0.413|||||TWO_SIDED|95.0|0.201|0.849|||||"Risk Ratio of platelet count immediately before the start of this drug \< 10 × 10⁴/μL to ≥ 10 × 10⁴/μL"|Subgroup analyses of platelet count immediately before the start of this drug||0.849|0.201|
91571299|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|0.299|||||TWO_SIDED|95.0|0.075|1.194|||||"Risk Ratio of peripheral blast count immediately before the start of this drug \> 1000 /μL to ≤ 1000 /μL"|Subgroup analyses of peripheral blast count immediately before the start of this drug||1.194|0.075|
91571300|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|2.415|||||TWO_SIDED|95.0|0.917|6.362|||||"Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||6.362|0.917|
91571301|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|1.688|||||TWO_SIDED|95.0|0.612|4.655|||||"Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||4.655|0.612|
91571302|NCT05923112|183031338|OTHER|Estimation|Risk Ratio (RR)|0.901|||||TWO_SIDED|95.0|0.408|1.99|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||1.990|0.408|
91571303|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.616|||||TWO_SIDED|95.0|0.086|4.391|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]||4.391|0.086|
91571304|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.188|1.491|||||"Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]||1.491|0.188|
91571305|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|1.012|||||TWO_SIDED|95.0|0.217|4.723|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||4.723|0.217|
91571306|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.905|||||TWO_SIDED|95.0|0.316|2.594|||||"Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]||2.594|0.316|
91571307|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.682|||||TWO_SIDED|95.0|0.085|5.455|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]||5.455|0.085|
91571308|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.789|||||TWO_SIDED|95.0|0.267|2.335|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||2.335|0.267|
91571309|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|2.583|||||TWO_SIDED|95.0|0.845|7.9|||||"Risk Ratio of hepatic impairment present to absent"|Subgroup analyses of hepatic impairment||7.900|0.845|
91571310|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.131|6.163|||||"Risk Ratio of past medical history - Hepatitis or hepatic disease present to absent"|Subgroup analyses of past medical history - Hepatitis or hepatic disease||6.163|0.131|
91571311|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|2.583|||||TWO_SIDED|95.0|0.845|7.9|||||"Risk Ratio of present medical history - Hepatitis or hepatic disease present to absent"|Subgroup analyses of present medical history - Hepatitis or hepatic disease||7.900|0.845|
91571312|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|2.769|||||TWO_SIDED|95.0|0.796|9.63|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||9.630|0.796|
91571313|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.418|8.827|||||"Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|Subgroup analyses of ECOG PS before the start of this drug||8.827|0.418|
91571314|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of ECOG PS before the start of this drug|"Regarding Risk Ratio of ECOG PS before the start of this drug not performed to 1"|||
91571315|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.615|||||TWO_SIDED|95.0|0.184|2.062|||||"Risk Ratio of AST and ALT levels immediately before the start of this drug either \> 1.5 × the institutional upper limit normal range (IULN) to ≤ 1.5 ×IULN"|Subgroup analyses of AST and ALT levels immediately before the start of this drug||2.062|0.184|
91571316|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.656|||||TWO_SIDED|95.0|0.249|1.729|||||"Risk Ratio of γ-GTP level immediately before the start of this drug \> 50 IU/L to ≤ 50 IU/L"|Subgroup analyses of γ-GTP level immediately before the start of this drug||1.729|0.249|
91571317|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of γ-GTP level immediately before the start of this drug|"Regarding Risk Ratio of γ-GTP level immediately before the start of this drug not performed to ≤ 50 IU/L"|||
91571318|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.707|||||TWO_SIDED|95.0|0.273|1.836|||||"Risk Ratio of platelet count immediately before the start of this drug \< 10 × 10⁴/μL to ≥ 10 × 10⁴/μL"|Subgroup analyses of platelet count immediately before the start of this drug||1.836|0.273|
91571319|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|0.245|||||TWO_SIDED|95.0|0.034|1.79|||||"Risk Ratio of peripheral blast count immediately before the start of this drug \> 1000 /μL to ≤ 1000 /μL"|Subgroup analyses of peripheral blast count immediately before the start of this drug||1.790|0.034|
91571320|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|2.927|||||TWO_SIDED|95.0|0.832|10.294|||||"Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||10.294|0.832|
91571321|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.296|5.279|||||"Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||5.279|0.296|
91571322|NCT05923112|183031339|OTHER|Estimation|Risk Ratio (RR)|1.545|||||TWO_SIDED|95.0|0.588|4.058|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||4.058|0.588|
91571323|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.528|||||TWO_SIDED|95.0|0.144|1.939|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]||1.939|0.144|
91571324|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.316|||||TWO_SIDED|95.0|0.849|2.041|||||"Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]||2.041|0.849|
91571325|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.084|||||TWO_SIDED|95.0|0.5|2.351|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||2.351|0.500|
91571326|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.293|||||TWO_SIDED|95.0|0.781|2.142|||||"Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]||2.142|0.781|
91571327|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.455|||||TWO_SIDED|95.0|0.12|1.715|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]||1.715|0.120|
91571328|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.605|1.653|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||1.653|0.605|
91571329|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.099|||||TWO_SIDED|95.0|0.542|2.228|||||"Risk Ratio of hepatic impairment present to absent"|Subgroup analyses of hepatic impairment||2.228|0.542|
91571330|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.069|||||TWO_SIDED|95.0|0.667|1.714|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.714|0.667|
91571331|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.909|||||TWO_SIDED|95.0|0.485|1.705|||||"Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.705|0.485|
91571332|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.459|||||TWO_SIDED|95.0|0.125|1.688|||||"Risk Ratio of ECOG PS before the start of this drug not performed to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.688|0.125|
91571333|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.889|||||TWO_SIDED|95.0|0.58|1.362|||||"Risk Ratio of white blood cell count immediately before the start of this drug ≥ 4000/mm³ to \< 4000/mm³"|Subgroup analyses of white blood cell count immediately before the start of this drug||1.362|0.580|
91571334|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.121|||||TWO_SIDED|95.0|0.728|1.725|||||"Risk Ratio of neutrophil count immediately before the start of this drug ≥ 2000/mm³ to \< 2000/mm³"|Subgroup analyses of neutrophil count immediately before the start of this drug||1.725|0.728|
91571335|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.639|1.536|||||"Risk Ratio of platelet count immediately before the start of this drug \< 10 × 10⁴/μL to ≥ 10 × 10⁴/μL"|Subgroup analyses of platelet count immediately before the start of this drug||1.536|0.639|
91571336|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.996|||||TWO_SIDED|95.0|1.093|3.643|||||"Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||3.643|1.093|
91571337|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.977|3.279|||||"Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||3.279|0.977|
91571338|NCT05923112|183031340|OTHER|Estimation|Risk Ratio (RR)|0.772|||||TWO_SIDED|95.0|0.464|1.286|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||1.286|0.464|
91571339|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.584|||||TWO_SIDED|95.0|0.158|2.159|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]||2.159|0.158|
91571340|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|1.104|||||TWO_SIDED|95.0|0.667|1.826|||||"Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]||1.826|0.667|
91571341|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.973|||||TWO_SIDED|95.0|0.41|2.311|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||2.311|0.410|
91571342|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|1.088|||||TWO_SIDED|95.0|0.624|1.897|||||"Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]||1.897|0.624|
91571343|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.545|||||TWO_SIDED|95.0|0.141|2.108|||||"Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]||2.108|0.141|
91571344|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.979|||||TWO_SIDED|95.0|0.547|1.753|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||1.753|0.547|
91571345|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.662|2.793|||||"Risk Ratio of hepatic impairment present to absent"|Subgroup analyses of hepatic impairment||2.793|0.662|
91571346|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.769|||||TWO_SIDED|95.0|0.439|1.349|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.349|0.439|
91571347|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.507|1.816|||||"Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.816|0.507|
91571348|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.242|||||TWO_SIDED|95.0|0.036|1.627|||||"Risk Ratio of ECOG PS before the start of this drug not performed to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.627|0.036|
91571349|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.848|||||TWO_SIDED|95.0|0.518|1.391|||||"Risk Ratio of white blood cell count immediately before the start of this drug ≥ 4000/mm³ to \< 4000/mm³"|Subgroup analyses of white blood cell count immediately before the start of this drug||1.391|0.518|
91571350|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|0.945|||||TWO_SIDED|95.0|0.578|1.547|||||"Risk Ratio of neutrophil count immediately before the start of this drug ≥ 2000/mm³ to \< 2000/mm³"|Subgroup analyses of neutrophil count immediately before the start of this drug||1.547|0.578|
91571351|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|1.156|||||TWO_SIDED|95.0|0.685|1.95|||||"Risk Ratio of platelet count immediately before the start of this drug \< 10 × 10⁴/μL to ≥ 10 × 10⁴/μL"|Subgroup analyses of platelet count immediately before the start of this drug||1.950|0.685|
91571352|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|2.195|||||TWO_SIDED|95.0|1.113|4.329|||||"Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||4.329|1.113|
91571353|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|1.667|||||TWO_SIDED|95.0|0.821|3.384|||||"Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||3.384|0.821|
91571354|NCT05923112|183031341|OTHER|Estimation|Risk Ratio (RR)|1.004|||||TWO_SIDED|95.0|0.586|1.719|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||1.719|0.586|
91571355|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]|"Regarding Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years"|||
91571356|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|2.383|||||TWO_SIDED|95.0|0.48|11.824|||||"Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]||11.824|0.480|
91571357|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|2.529|||||TWO_SIDED|95.0|0.168|38.18|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||38.180|0.168|
91571358|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|2.829|||||TWO_SIDED|95.0|0.342|23.432|||||"Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]||23.432|0.342|
91571359|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]|"Regarding Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years"|||
91571360|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.789|||||TWO_SIDED|95.0|0.161|3.862|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||3.862|0.161|
91571361|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of hepatic impairment|"Regarding Risk Ratio of hepatic impairment present to absent"|||
91571362|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.923|||||TWO_SIDED|95.0|0.196|4.355|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||4.355|0.196|
91571363|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.07|5.84|||||"Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|Subgroup analyses of ECOG PS before the start of this drug||5.840|0.070|
91571364|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of ECOG PS before the start of this drug|"Regarding Risk Ratio of ECOG PS before the start of this drug not performed to 1"|||
91571365|NCT05923112|183031342|OTHER|Estimation|Risk Ratio (RR)|0.386|||||TWO_SIDED|95.0|0.048|3.107|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||3.107|0.048|
91571366|NCT05923112|183031342|OTHER|Estimation||||||||||||||||Subgroup analyses of salvage line of the induction treatment with this drug|"Regarding Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571367|NCT05923112|183031342|OTHER|Estimation||||||||||||||||Subgroup analyses of salvage line of the induction treatment with this drug|"Regarding Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571368|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]|"Regarding Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years"|||
91571369|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.953|||||TWO_SIDED|95.0|0.139|6.556|||||"Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years"|Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]||6.556|0.139|
91571370|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|2.529|||||TWO_SIDED|95.0|0.168|38.18|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||38.180|0.168|
91571371|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|1.132|||||TWO_SIDED|95.0|0.106|12.119|||||"Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]||12.119|0.106|
91571372|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]|"Regarding Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years"|||
91571373|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.316|||||TWO_SIDED|95.0|0.046|2.146|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||2.146|0.046|
91571374|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of hepatic impairment|"Regarding Risk Ratio of hepatic impairment present to absent"|||
91571375|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.462|||||TWO_SIDED|95.0|0.043|4.928|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||4.928|0.043|
91571376|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.091|10.079|||||"Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|Subgroup analyses of ECOG PS before the start of this drug||10.079|0.091|
91571377|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of ECOG PS before the start of this drug|"Regarding Risk Ratio of ECOG PS before the start of this drug not performed to 1"|||
91571378|NCT05923112|183031343|OTHER|Estimation|Risk Ratio (RR)|0.772|||||TWO_SIDED|95.0|0.083|7.207|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||7.207|0.083|
91571379|NCT05923112|183031343|OTHER|Estimation||||||||||||||||Subgroup analyses of salvage line of the induction treatment with this drug|"Regarding Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571380|NCT05923112|183031343|OTHER|Estimation||||||||||||||||Subgroup analyses of salvage line of the induction treatment with this drug|"Regarding Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571381|NCT05923112|183031344|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of hepatic impairment|"Regarding Risk Ratio of hepatic impairment present to absent"|||
91571382|NCT05923112|183031344|OTHER|Estimation|Risk Ratio (RR)|0.923|||||TWO_SIDED|95.0|0.059|14.352|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||14.352|0.059|
91571383|NCT05923112|183031344|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of ECOG PS before the start of this drug|"Regarding Risk Ratio of ECOG PS before the start of this drug ≥ 2 to 1"|||
91571384|NCT05923112|183031344|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of ECOG PS before the start of this drug|"Regarding Risk Ratio of ECOG PS before the start of this drug not performed to 1"|||
91571385|NCT05923112|183031344|OTHER|Estimation|Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|||||||The risk ratio was reported as participants in this group are related to Category(A).|Subgroup analyses of HSCT before the start of this drug|"Regarding Risk Ratio of HSCT before the start of this drug performed to not performed"|||
91571386|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 65 years\]|"Regarding Risk Ratio of age \< 15 years to ≥ 15 to \< 65 years, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571387|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of age \[≥ 65 years, ≥ 15 to \< 65 years\]|"Regarding Risk Ratio of age ≥ 65 years to ≥ 15 to \< 65 years, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571388|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]|"Regarding Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571389|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of age \[≥ 55 years, ≥ 18 to \< 55 years\]|"Regarding Risk Ratio of age ≥ 55 years to ≥ 18 to \< 55 years, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571390|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of age \[\< 15 years, ≥ 15 to \< 40 years\]|"Regarding Risk Ratio of age \< 15 years to ≥ 15 to \< 40 years, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571391|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]|"Regarding Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571392|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of salvage line of the induction treatment with this drug|"Regarding Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571393|NCT05923112|183031344|OTHER|Estimation||||||||||||||||Subgroup analyses of salvage line of the induction treatment with this drug|"Regarding Risk Ratio of salvage line of the induction treatment with this drug 3rd or later to 1st, the risk ratio was reported as participants in this group are related to Category(B)."|||
91571394|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.333|||||TWO_SIDED|95.0|0.046|2.405|||||"Risk Ratio of age \< 18 years to ≥ 18 to \< 55 years"|Subgroup analyses of age \[\< 18 years, ≥ 18 to \< 55 years\]||2.405|0.046|
91571395|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.34|3.56|||||"Risk Ratio of age ≥ 40 years to ≥ 15 to \< 40 years"|Subgroup analyses of age \[≥ 40 years, ≥ 15 to \< 40 years\]||3.560|0.340|
91571396|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|1.227|||||TWO_SIDED|95.0|0.371|4.056|||||"Risk Ratio of chromosome karyotype Philadelphia chromosome positive to negative"|Subgroup analyses of chromosome karyotype||4.056|0.371|
91571397|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.183|1.966|||||"Risk Ratio of ECOG PS before the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before the start of this drug||1.966|0.183|
91571398|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.284|2.481|||||"Risk Ratio of hemoglobin level immediately before the start of this drug \< 10 g/dL to ≥ 10 g/dL"|Subgroup analyses of hemoglobin level immediately before the start of this drug||2.481|0.284|
91571399|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.604|6.621|||||"Risk Ratio of platelet count immediately before the start of this drug \< 10 × 10⁴/μL to ≥ 10 × 10⁴/μL"|Subgroup analyses of platelet count immediately before the start of this drug||6.621|0.604|
91571400|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.917|||||TWO_SIDED|95.0|0.278|3.026|||||"Risk Ratio of myeloblast count immediately before the start of this drug \> 50% to ≤ 50%"|Subgroup analyses of myeloblast count immediately before the start of this drug||3.026|0.278|
91571401|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.264|||||TWO_SIDED|95.0|0.036|1.93|||||"Risk Ratio of salvage line of the induction treatment with this drug 2nd to 1st"|Subgroup analyses of salvage line of the induction treatment with this drug||1.930|0.036|
91571402|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|1.438|||||TWO_SIDED|95.0|0.497|4.161|||||"Risk Ratio of HSCT before the start of this drug performed to not performed"|Subgroup analyses of HSCT before the start of this drug||4.161|0.497|
91571403|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.616|||||TWO_SIDED|95.0|0.187|2.03|||||"Risk Ratio of type of the first HSCT after the start of this drug allogeneic hematopoietic stem cell transplant with myeloablative conditioning to allogeneic hematopoietic stem cell transplant with nonmyeloablative conditioning"|Subgroup analyses of type of the first HSCT after the start of this drug||2.030|0.187|
91571404|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|0.583|||||TWO_SIDED|95.0|0.155|2.192|||||"Risk Ratio of ECOG PS before conditioning for the first HSCT after the start of this drug 0 to 1"|Subgroup analyses of ECOG PS before conditioning for the first HSCT after the start of this drug||2.192|0.155|
91571405|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|2.545|||||TWO_SIDED|95.0|0.63|10.293|||||"Risk Ratio of hemoglobin level before conditioning for the first HSCT after the start of this drug \< 10 g/dL to ≥ 10 g/dL"|Subgroup analyses of hemoglobin level before conditioning for the first HSCT after the start of this drug||10.293|0.630|
91571406|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|1.179|||||TWO_SIDED|95.0|0.237|5.87|||||"Risk Ratio of time from the date of final dose of this drug to the date of the first HSCT after the start of this drug ≥ 4 weeks to \< 8 weeks to \< 4 weeks"|Subgroup analyses of time from the date of final dose of this drug to the date of the first HSCT after the start of this drug||5.870|0.237|
91571407|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|2.182|||||TWO_SIDED|95.0|0.665|7.158|||||"Risk Ratio of best overall response progression or relapse to complete remission (CR) or complete remission with incomplete hematologic recovery (CRi)"|Subgroup analyses of best overall response||7.158|0.665|
91571408|NCT05923112|183031346|OTHER|Estimation|Risk Ratio (RR)|1.538|||||TWO_SIDED|95.0|0.392|6.037|||||"Risk Ratio of MRD test not performed to negativity achieved"|Subgroup analyses of minimal residual disease (MRD)||6.037|0.392|
91571409|NCT05781750|183031367|OTHER|Trial was early terminated.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|3.3||||||Time to complete renal response for zetomipzomib 30 mg + standard-of-care versus placebo + standard-of-care||3.3|0.2|
91571410|NCT05781750|183031367|OTHER|Trial was early terminated.|Hazard Ratio (HR)|2.1|||||TWO_SIDED|95.0|0.7|6.7||||||Time to complete renal response for zetomipzomib 60 mg + standard-of-care versus placebo + standard-of-care||6.7|0.7|
91571411|NCT05781750|183031367|OTHER|Trial was early terminated.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.5|3.0||||||Time to partial renal response for zetomipzomib 30 mg + standard-of-care versus placebo + standard-of-care||3.0|0.5|
91571412|NCT05781750|183031367|OTHER|Trial was early terminated.|Hazard Ratio (HR)|2.6|||||TWO_SIDED|95.0|1.1|5.9||||||Time to partial renal response zetomipzomib 60 mg + standard-of-care versus placebo + standard-of-care||5.9|1.1|
91571413|NCT00992992|183031381|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|56.0|||||TWO_SIDED|95.0|37.0|75.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response (CR).|||75|37|
91571414|NCT00992992|183031381|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|19.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response unconfirmed (CRu).|||19|0|
91571415|NCT00992992|183031381|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|20.0|||||TWO_SIDED|95.0|4.0|36.0|||||The estimated value reflects the percentage of participants with unconfirmed partial response.|||36|4|
91571416|NCT01390441|183031436|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.87|1.16|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.16|0.87|
91571417|NCT01390441|183031438|SUPERIORITY_OR_OTHER||Percent difference|-17.2|||||TWO_SIDED|95.0|-38.6|3.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m\^2 - Part A: MabThera 500 mg/m\^2) when \>=4 participants in an arm experienced an event.||3.6|-38.6|
91571418|NCT01390441|183031438|SUPERIORITY_OR_OTHER||Percent difference|-17.5|||||TWO_SIDED|95.0|-44.4|10.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when \>=4 participants in an arm experienced an event.||10.9|-44.4|
91571419|NCT01390441|183031438|SUPERIORITY_OR_OTHER||Percent difference|-5.6|||||TWO_SIDED|95.0|-34.9|24.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||24.6|-34.9|
91571420|NCT01390441|183031438|SUPERIORITY_OR_OTHER||Percent differnce|12.0|||||TWO_SIDED|95.0|-15.6|38.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||38.9|-15.6|
91571421|NCT01390441|183031440|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.87|1.1|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.1|0.87|
91571422|NCT01390441|183031444|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 6 weeks.||0.5|-0.9|
91571423|NCT01390441|183031444|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 12 weeks.||1.2|-0.4|
91571424|NCT02446613|183031447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.41|5.43|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1071.|||5.43|-1.41|
91571425|NCT02446613|183031448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.98|3.75|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2417.|||3.75|-1.98|
91571426|NCT02446613|183031449|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.08|1.87|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2876.|||1.87|-1.08|
91571427|NCT02446613|183031450|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.9|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-1.86|5.34|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1453.|||5.34|-1.86|
91571428|NCT02446613|183031451|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.6|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-10.7|19.71|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2665.|||19.71|-10.70|
91571429|NCT02446613|183031452|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.3|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-14.97|24.38|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.3266|||24.38|-14.97|
91571430|NCT02446613|183031453|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.1|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-17.47|19.2|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.4528|||19.20|-17.47|
91571431|NCT02446613|183031454|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.6|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-13.69|28.04|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2525|||28.04|-13.69|
91571432|NCT04788511|183031456|SUPERIORITY||Estimated Treatment Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.8|10.9|||ANCOVA|||The responses at week 52 were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline KCCQ-CSS as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||10.9|4.8|<0.0001
91571433|NCT04788511|183031457|SUPERIORITY||Estimated Treatment Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-11.9|-9.4|||ANCOVA|||The responses were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline body weight (kg) as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||-9.4|-11.9|<0.0001
91571434|NCT03178045|183031478|OTHER|Multivariable Logistic Regression|Estimated Increase|0.23|||||TWO_SIDED|95.0|-3.1|3.6||||||||3.6|-3.1|
91571435|NCT03178045|183031479|OTHER|Multivariable logistic regression|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.69|1.31||||||||1.31|0.69|
91571436|NCT03178045|183031480|OTHER|Longitudinal mixed effects regression|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.6|1.32||||||||1.32|0.60|
91571437|NCT04069585|183031509|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0002||||||One-sided paired t-test|t-test, 1 sided|||||||<0.0002
91571438|NCT00087555|183031536|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||Chi-squared|||||||0.052
91571439|NCT00087555|183031536|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Chi-squared|||||||0.024
91571440|NCT00087555|183031536|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
91571441|NCT01062971|183031537|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91571442|NCT01062971|183031538|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%.|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91571443|NCT03738397|183031552|SUPERIORITY||Adjusted Response Rate Difference|9.7||||0.007|TWO_SIDED|95.0|2.6|16.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||16.7|2.6|0.007
91571444|NCT03738397|183031553|SUPERIORITY||Least Squares (LS) Mean Difference|-18.21|STANDARD_ERROR_OF_MEAN|2.753|<|0.001|TWO_SIDED|95.0|-23.61|-12.8||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-12.80|-23.61|<0.001
91571445|NCT03738397|183031554|SUPERIORITY||Adjusted Response Rate Difference|20.4|||<|0.001|TWO_SIDED|95.0|14.8|26.0||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||26.0|14.8|<0.001
91571446|NCT03738397|183031555|SUPERIORITY||Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.8|28.6||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||28.6|13.8|<0.001
91571447|NCT03738397|183031556|SUPERIORITY||LS Mean Difference|-28.02|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|95.0|-34.25|-21.78||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-21.78|-34.25|<0.001
91571448|NCT03738397|183031557|SUPERIORITY||Adjusted Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.3|32.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||32.7|19.3|<0.001
91571449|NCT03738397|183031558|SUPERIORITY||LS Mean Difference|-23.02|STANDARD_ERROR_OF_MEAN|2.548|<|0.001|TWO_SIDED|95.0|-28.03|-18.02||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-18.02|-28.03|<0.001
91571450|NCT03738397|183031559|SUPERIORITY||Adjusted Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.4|27.3||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||27.3|12.4|<0.001
91571451|NCT01795859|183031560|SUPERIORITY_OR_OTHER||LSMean Difference|-2.49|||<|0.0001|TWO_SIDED|95.0|-3.69|-1.29|||ANCOVA|||||-1.29|-3.69|<0.0001
91571452|NCT01795859|183031561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.002|TWO_SIDED|95.0|12.4|49.8|||Difference of proportions|||||49.8|12.4|0.0020
91571453|NCT01795859|183031562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9||||0.0022|TWO_SIDED|95.0|11.4|46.4|||Difference of proportions|||||46.4|11.4|0.0022
91571454|NCT01795859|183031563|SUPERIORITY_OR_OTHER||LSMean Difference|4.34||||0.0308|TWO_SIDED|95.0|0.41|8.27|||Mixed Models Analysis|||||8.27|0.41|0.0308
91571455|NCT01795859|183031564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.1415|TWO_SIDED|95.0|-0.3|2.3|||Mixed Models Analysis|||||2.3|-0.3|0.1415
91571456|NCT02165826|183031599|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.017|TWO_SIDED|95.0|0.47|0.93||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.93|0.47|0.017
91571457|NCT02165826|183031599|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.51|0.92|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||0.92|0.51|
91571458|NCT02165826|183031599|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.114|TWO_SIDED|95.0|0.55|1.07||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.07|0.55|0.114
91571459|NCT02165826|183031599|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.77|||||TWO_SIDED|95.0|0.58|1.02|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||1.02|0.58|
91571460|NCT02165826|183031600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.001|TWO_SIDED|95.0|0.47|0.83||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.83|0.47|0.001
91571461|NCT02165826|183031600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.59|1.04||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.04|0.59|0.091
91571462|NCT04887506|183031617|EQUIVALENCE|If the 90% confidence interval (CI) fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|||||||The 90% CIs for the geometric mean ratio (GMR) were not evaluable.|Primary analysis of equivalence of TAVT 45 and R AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10).||||
91571463|NCT04887506|183031618|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.975|||||TWO_SIDED|90.0|0.944|1.007||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the CS-ITT population.||1.007|0.944|
91571464|NCT04887506|183031619|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.978|1.002||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the mITT population.||1.002|0.978|
91571465|NCT04887506|183031620|EQUIVALENCE|Odds ratio generated using the Wald method.|Odds Ratio (OR)|1.69||||0.3408|TWO_SIDED|95.0|0.574|4.979|||Regression, Logistic|||||4.979|0.574|0.3408
91571466|NCT01963169|183031621|SUPERIORITY||Effect size|0.54|||<|0.001|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for Knowledge outcome using the revised Osteoporosis Knowledge Test.|At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.||||< 0.001
91571467|NCT01963169|183031621|SUPERIORITY||Effect size|0.33|||<|0.001|TWO_SIDED|||||\<0.05 (threshold)|Mixed Models Analysis||The above values are for the exercise behavior variable assessed by the 9-item Self-Efficacy for Exercise scale.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||<0.001
91571468|NCT01963169|183031621|SUPERIORITY||Effect size|0.2||||0.009|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for calcium outcome expectation..|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.009
91571469|NCT01963169|183031621|SUPERIORITY||Effect Size|0.18||||0.002|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise self-efficacy.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.002
91571470|NCT01963169|183031621|SUPERIORITY||Effect size|0.14||||0.032|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise outcome expectation.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.032
91571471|NCT05238103|183031660|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
91571472|NCT05238103|183031661|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||For systolic blood pressure||||0.40
91571473|NCT05238103|183031661|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||For diastolic blood pressure||||0.25
91571474|NCT05238103|183031662|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.27
91571475|NCT05238103|183031663|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
91571476|NCT05238103|183031664|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
91571477|NCT05238103|183031665|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||For: Global physical health score||||0.16
91571478|NCT05238103|183031665|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||For: Global mental health score||||0.71
91571479|NCT05238103|183031666|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
91571480|NCT05238103|183031667|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
91571481|NCT05238103|183031668|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
91571482|NCT05238103|183031669|SUPERIORITY|||||||0.09|||||||Chi-squared|||||||0.09
91571483|NCT05238103|183031670|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
91571484|NCT05238103|183031671|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
91571485|NCT05238103|183031672|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
91571486|NCT05238103|183031673|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
91571487|NCT05238103|183031679|NON_INFERIORITY|The non-inferiority margin of 12.5 meters was chosen to represent about 40% of the minimum important difference of 30 meters in the 6 minute walk test as identified in previous studies. For sample size calculation, to allow for an attrition rate of 20% during follow up after randomization, a total of 200 (100 per group) participants were needed to be recruited and then randomized in a 1:1 ration to Intervention vs. Control groups.|Mean Difference (Final Values)|16.3||||0.04|ONE_SIDED|95.0|-9.1||||t-test, 1 sided|||Significance testing: Generalized regression model|||-9.1|0.04
91571488|NCT05739994|183031681|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.55|TWO_SIDED|||||Pairwise p-values were calculated using independent-samples t-tests on final values because model-based pairwise contrasts were not available. These values do not reflect the full repeated-measures mixed-model structure.|t-test, 2 sided|||||||0.55
91571489|NCT05739994|183031681|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.18|TWO_SIDED|||||Pairwise p-values were calculated using independent-samples t-tests on final values because model-based pairwise contrasts were not available. These values do not reflect the full repeated-measures mixed-model structure.|t-test, 2 sided|||||||0.18
91571490|NCT05739994|183031682|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.1|TWO_SIDED|||||Pairwise p-values were calculated using independent-samples t-tests on final values because model-based pairwise contrasts were not available. These values do not reflect the full repeated-measures mixed-model structure.|t-test, 2 sided|||||||0.1
91571491|NCT05739994|183031682|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.79|TWO_SIDED|||||Pairwise p-values were calculated using independent-samples t-tests on final values because model-based pairwise contrasts were not available. These values do not reflect the full repeated-measures mixed-model structure.|t-test, 2 sided|||||||0.79
91571492|NCT04750577|183031688|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0245|||||||MCP-Mod exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0245
91571493|NCT04750577|183031688|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0294|||||||MCP-Mod linear model fit|Model assumption: No assumption was needed.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0294
91571494|NCT04750577|183031688|OTHER|A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||||0.0468||||||MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.|MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||||||0.0468
91571495|NCT04750577|183031688|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0586|||||||MCP-Mod Emax model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0586
91571496|NCT04750577|183031688|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0659|||||||MCP-Mod Sigmoid emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0659
91571497|NCT04750577|183031688|OTHER||Mean Difference (Net)|-0.103||||0.3224|TWO_SIDED|95.0|-0.309|0.102|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean ofPlacebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.102|-0.309|0.3224
91571498|NCT04750577|183031688|OTHER||Mean Difference (Net)|-0.063||||0.5616|TWO_SIDED|95.0|-0.275|0.15|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.150|-0.275|0.5616
91571499|NCT04750577|183031688|OTHER||Mean Difference (Net)|-0.251||||0.0183|TWO_SIDED|95.0|-0.459|-0.043|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.043|-0.459|0.0183
91571500|NCT04750577|183031689|OTHER||Mean Difference (Net)|-0.211||||0.0396|TWO_SIDED|0.95|-0.413|-0.01|||Mixed Models Analysis||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.010|-0.413|0.0396
91571501|NCT04750577|183031689|OTHER||Mean Difference (Net)|-0.12||||0.2568|TWO_SIDED|0.95|-0.327|0.088|||Mixed Models Analysis||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.088|-0.327|0.2568
91571502|NCT04750577|183031689|OTHER||Mean Difference (Net)|-0.357||||0.0006|TWO_SIDED|0.95|-0.56|-0.154|||Mixed Models Analysis||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.154|-0.560|0.0006
91571503|NCT04750577|183031690|OTHER||Odds Ratio (OR)|2.25||||0.0519|TWO_SIDED|95.0|0.99|5.1|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||5.10|0.99|0.0519
91571504|NCT04750577|183031690|OTHER||Odds Ratio (OR)|1.43||||0.4159|TWO_SIDED|95.0|0.61|3.36|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.36|0.61|0.4159
91571505|NCT04750577|183031690|OTHER||Odds Ratio (OR)|2.9||||0.0106|TWO_SIDED|95.0|1.28|6.55|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.55|1.28|0.0106
91571506|NCT04750577|183031691|OTHER||Odds Ratio (OR)|2.79||||0.0176|TWO_SIDED|95.0|1.2|6.53|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.53|1.20|0.0176
91571507|NCT04750577|183031691|OTHER||Odds Ratio (OR)|1.32||||0.5467|TWO_SIDED|95.0|0.53|3.29|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.29|0.53|0.5467
91571508|NCT04750577|183031691|OTHER||Odds Ratio (OR)|4.46||||0.0005|TWO_SIDED|95.0|1.91|10.39|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||10.39|1.91|0.0005
91571509|NCT02473042|183031693|SUPERIORITY|||||||0.2787|||||||Chi-squared|||||||0.2787
91571510|NCT02473042|183031696|SUPERIORITY|||||||0.8252|||||||Wilcoxon (Mann-Whitney)|||||||0.8252
91571511|NCT02473042|183031697|SUPERIORITY|||||||0.8277|||||||Wilcoxon (Mann-Whitney)|||||||0.8277
91571512|NCT02473042|183031698|SUPERIORITY|||||||0.3908|||||||Chi-squared|||Response to ASES\_Coping question (Re-categorized)||||0.3908
91571513|NCT02473042|183031698|SUPERIORITY|||||||0.6029|||||||Chi-squared|||Response to ASES\_Nausea question||||0.6029
91571514|NCT02473042|183031698|SUPERIORITY|||||||0.7785|||||||Chi-squared|||Response to ASES\_Pain question||||0.7785
91571515|NCT02473042|183031698|SUPERIORITY|||||||0.8434|||||||Chi-squared|||Response to ASES\_Recovery question (Re-categorized)||||0.8434
91571516|NCT02473042|183031699|OTHER|||||||0.2742|||||||Chi-squared|||Response to ASES\_Coping question (Re-categorized) and P6 stimulation outcome||||0.2742
91571517|NCT02473042|183031699|OTHER|||||||0.2747|||||||Chi-squared|||Response to ASES\_Nausea question (Re-categorized) and P6 stimulation outcome||||0.2747
91571518|NCT02473042|183031699|OTHER|||||||0.5608|||||||Chi-squared|||Response to ASES\_Pain question (Re-categorized) and P6 stimulation outcome||||0.5608
91571519|NCT02473042|183031699|OTHER|||||||0.1014||||||There is no statistically significant association between expectancy and complete PONV control.|Chi-squared|||Response to ASES\_Recovery question (Re-categorized) and P6 stimulation outcome||||0.1014
91571520|NCT05093504|183031752|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91571521|NCT03151551|183031761|SUPERIORITY||Rate Difference|8.1||||0.036|TWO_SIDED|95.0|0.5|15.8|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||15.8|0.5|0.036
91571522|NCT03151551|183031762|NON_INFERIORITY|If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.|Rate Difference|3.9|||||TWO_SIDED|95.0|-4.3|12.1||||||||12.1|-4.3|
91571523|NCT03151551|183031763|SUPERIORITY||Rate Difference|13.4||||0.001|TWO_SIDED|95.0|5.3|21.6|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||21.6|5.3|0.001
91571524|NCT03151551|183031764|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.725||0.155|TWO_SIDED|95.0|-2.46|0.39|||Mixed Models Analysis|||||0.39|-2.46|0.155
91571525|NCT03151551|183031765|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.249||0.823|TWO_SIDED|95.0|-0.54|0.43|||Mixed Models Analysis|||||0.43|-0.54|0.823
91571526|NCT03151551|183031766|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|2.104||0.752|TWO_SIDED|95.0|-4.8|3.47|||Mixed Models Analysis|||||3.47|-4.80|0.752
91571527|NCT03151551|183031767|SUPERIORITY||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|2.06||0.177|TWO_SIDED|95.0|-6.83|1.26|||Mixed Models Analysis|||||1.26|-6.83|0.177
91571528|NCT03151551|183031768|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.391||0.332|TWO_SIDED|95.0|-4.08|1.38|||Mixed Models Analysis|||||1.38|-4.08|0.332
91571529|NCT03151551|183031769|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.599||0.592|TWO_SIDED|95.0|-0.86|1.5|||Mixed Models Analysis|||||1.50|-0.86|0.592
91571530|NCT03151551|183031770|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.176|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|||||0.03|-0.15|0.176
91571531|NCT03151551|183031771|SUPERIORITY||Rate Difference|13.1|||<|0.001|TWO_SIDED|95.0|5.4|20.7|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 52.||20.7|5.4|<0.001
91571532|NCT03151551|183031772|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.091||0.368|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|0.368
91571533|NCT03151551|183031773|SUPERIORITY||Rate Difference|6.4||||0.108|TWO_SIDED|95.0|-1.8|14.5|||Regression, Logistic|||MDA-18 Entheseal Points||14.5|-1.8|0.108
91571534|NCT03151551|183031773|SUPERIORITY||Rate Difference|5.3||||0.179|TWO_SIDED|95.0|-2.9|13.5|||Regression, Logistic|||MDA-6 Entheseal Points||13.5|-2.9|0.179
91571535|NCT03151551|183031774|SUPERIORITY||Rate Difference|-1.1||||0.846|TWO_SIDED|95.0|-8.9|6.7|||Regression, Logistic|||||6.7|-8.9|0.846
91571536|NCT03151551|183031775|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.83|-0.16|||Mixed Models Analysis|||||-0.16|-0.83|0.004
91571537|NCT03151551|183031776|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.305||0.687|TWO_SIDED|95.0|-0.48|0.72|||Mixed Models Analysis|||||0.72|-0.48|0.687
91571538|NCT03151551|183031777|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.507|TWO_SIDED|95.0|-0.19|0.38|||Mixed Models Analysis|||||0.38|-0.19|0.507
91571539|NCT03151551|183031778|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|14.951||0.82|TWO_SIDED|95.0|-32.78|25.99|||Mixed Models Analysis|||||25.99|-32.78|0.820
91571540|NCT03151551|183031779|SUPERIORITY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.79||0.052|TWO_SIDED|95.0|-3.09|0.02|||Mixed Models Analysis|||||0.02|-3.09|0.052
91571541|NCT03151551|183031780|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.949||0.005|TWO_SIDED|95.0|-4.57|-0.84|||Mixed Models Analysis|||||-0.84|-4.57|0.005
91571542|NCT03151551|183031781|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.158|TWO_SIDED|95.0|-0.68|0.11|||Mixed Models Analysis|||||0.11|-0.68|0.158
91571543|NCT03151551|183031782|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.711|TWO_SIDED|95.0|-0.49|0.33|||Mixed Models Analysis|||||0.33|-0.49|0.711
91571544|NCT03151551|183031783|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.674||0.439|TWO_SIDED|95.0|-0.8|1.85|||Mixed Models Analysis|||||1.85|-0.80|0.439
91571545|NCT03151551|183031784|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.86||0.594|TWO_SIDED|95.0|-1.23|2.15|||Mixed Models Analysis|||||2.15|-1.23|0.594
91571546|NCT03151551|183031785|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.979|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||||0.03|-0.03|0.979
91571547|NCT03151551|183031786|SUPERIORITY||Mean Difference (Final Values)|4.78|STANDARD_ERROR_OF_MEAN|1.782||0.008|TWO_SIDED|95.0|1.28|8.28|||Mixed Models Analysis|||||8.28|1.28|0.008
91571548|NCT03151551|183031787|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.335|<|0.001|TWO_SIDED|95.0|-1.78|-0.46|||Mixed Models Analysis|||||-0.46|-1.78|<0.001
91571549|NCT03151551|183031788|SUPERIORITY||Rate Difference|5.7||||0.165|TWO_SIDED|95.0|-2.4|13.7|||Regression, Logistic|||Effectiveness of Medication||13.7|-2.4|0.165
91571550|NCT03151551|183031788|SUPERIORITY||Rate Difference|6.7||||0.098|TWO_SIDED|95.0|-1.4|14.8|||Regression, Logistic|||Effectiveness over Time of Medication||14.8|-1.4|0.098
91571551|NCT03151551|183031788|SUPERIORITY||Rate Difference|4.6||||0.241|TWO_SIDED|95.0|-3.4|12.6|||Regression, Logistic|||Long Term Safety of Medication||12.6|-3.4|0.241
91571552|NCT03151551|183031788|SUPERIORITY||Rate Difference|4.9||||0.215|TWO_SIDED|95.0|-3.1|13.0|||Regression, Logistic|||Overall Satisfaction with Medication||13.0|-3.1|0.215
91571553|NCT03151551|183031788|SUPERIORITY||Rate Difference|2.1||||0.561|TWO_SIDED|95.0|-5.5|9.7|||Regression, Logistic|||Mostly Satisfied to any Questions||9.7|-5.5|0.561
91571554|NCT01867047|183031810|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for intraoperative mild hypotension||||0.140
91571555|NCT01867047|183031810|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Statistical analysis for postoperative mild hypotension||||1.000
91571556|NCT01867047|183031812|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||Analysis for number of participants given vasopressors intraoperatively||||0.102
91571557|NCT01867047|183031815|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.700
91571558|NCT01867047|183031816|SUPERIORITY|||||||0.702|||||||t-test, 2 sided|||||||0.702
91571559|NCT02825251|183031883|NON_INFERIORITY|Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.|Treatment difference|0.09|||||TWO_SIDED|95.0|0.01|0.17|||ANOVA|||Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.||0.17|0.01|
91571560|NCT01641653|183031974|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.||||0.87
91571561|NCT01641653|183031975|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||percent change in glucose levels from preoperative level to maximum perioperative measurement level||||0.56
91571562|NCT01641653|183031976|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||Chi-square with continuity correction|Chi-squared, Corrected|||||||0.12
91571563|NCT00349466|183031977|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
91571564|NCT00349466|183031978|SUPERIORITY|||||||0.083|||||||ANCOVA|||||||0.083
91571565|NCT00349466|183031979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||||||0.028
91571566|NCT00349466|183031980|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
91571567|NCT00349466|183031981|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
91571568|NCT00349466|183031982|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
91571569|NCT00349466|183031983|SUPERIORITY|||||||0.807|||||||ANCOVA|||||||.807
91571570|NCT05064488|183032011|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters AUC0-inf based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates digoxin.|Ratio|118.49|||||TWO_SIDED|90.0|111.89|125.47||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||125.47|111.89|
91571571|NCT05064488|183032012|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters AUC0-inf based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates metformin.|Ratio|208.95|||||TWO_SIDED|90.0|155.48|280.82||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||280.82|155.48|
91571572|NCT05064488|183032013|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters AUC0-inf based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates rosuvastatin.|Ratio|99.05|||||TWO_SIDED|90.0|80.49|121.89||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||121.89|80.49|
91571573|NCT05064488|183032014|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters AUC0-inf based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates sumatriptan.|Ratio|89.35||||||90.0|82.7|96.54||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||96.54|82.70|
91571574|NCT05064488|183032015|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters Cmax based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates digoxin.|Ratio|100.64|||||TWO_SIDED|90.0|85.99|117.79||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||117.79|85.99|
91571575|NCT05064488|183032016|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters Cmax based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates metformin.|Ratio|203.08|||||TWO_SIDED|90.0|152.93|269.68||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||269.68|152.93|
91571576|NCT05064488|183032017|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters Cmax based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates rosuvastatin.|Ratio|91.74|||||TWO_SIDED|90.0|76.98|109.33||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||109.33|76.98|
91571577|NCT05064488|183032018|OTHER|A general linear model with a fixed effect for treatment and a random effect for participant was applied to log-transformed PK parameters Cmax based on the PK analysis set to assess the effect of multiple doses of evobrutinib on the PK of the transporter substrates sumatriptan.|Ratio|81.02|||||TWO_SIDED|90.0|74.23|88.42||||||Treatment differences on the log scale of transporter substrates with evobrutinib vs substrates alone.||88.42|74.23|
91571578|NCT05064488|183032032|OTHER||Ratio|106.83|||||TWO_SIDED|90.0|102.11|111.76||||||||111.76|102.11|
91571579|NCT05064488|183032033|OTHER||Ratio|211.42|||||TWO_SIDED|90.0|156.34|285.91||||||||285.91|156.34|
91571580|NCT05064488|183032034|OTHER||Ratio|99.57|||||TWO_SIDED|90.0|79.69|124.42||||||||124.42|79.69|
91571581|NCT05064488|183032035|OTHER||Ratio|88.83|||||TWO_SIDED|90.0|82.04|96.19||||||||96.19|82.04|
91571582|NCT03616964|183032049|SUPERIORITY||Odds Ratio (OR)|1.07||||0.711|TWO_SIDED|95.0|0.75|1.53|||Regression, Logistic|||||1.53|0.75|0.711
91571583|NCT03616964|183032050|SUPERIORITY||Odds Ratio (OR)|1.05||||0.789|TWO_SIDED|95.0|0.73|1.5|||Regression, Logistic|||||1.50|0.73|0.789
91571584|NCT03616964|183032051|SUPERIORITY||Odds Ratio (OR)|1.1||||0.673|TWO_SIDED|95.0|0.72|1.68|||Regression, Logistic|||||1.68|0.72|0.673
91571585|NCT03616964|183032051|SUPERIORITY||Odds Ratio (OR)|1.15||||0.528|TWO_SIDED|95.0|0.75|1.75|||Regression, Logistic|||||1.75|0.75|0.528
91571586|NCT03616964|183032053|SUPERIORITY||Odds Ratio (OR)|0.91||||0.761|TWO_SIDED|95.0|0.51|1.64|||Regression, Logistic|||||1.64|0.51|0.761
91571587|NCT03616964|183032053|SUPERIORITY||Odds Ratio (OR)|1.17||||0.611|TWO_SIDED|95.0|0.65|2.1|||Regression, Logistic|||||2.10|0.65|0.611
91571588|NCT03616964|183032054|SUPERIORITY||LS Mean difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.698|TWO_SIDED|95.0|-0.47|0.32|||Mixed Models Analysis|||||0.32|-0.47|0.698
91571589|NCT03616964|183032054|SUPERIORITY||LS Mean difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.744|TWO_SIDED|95.0|-0.46|0.33|||Mixed Models Analysis|||||0.33|-0.46|0.744
91571590|NCT03616964|183032055|SUPERIORITY||LS Mean difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.84||0.665|TWO_SIDED|95.0|-2.0|1.28|||Mixed Models Analysis|||||1.28|-2.00|0.665
91571591|NCT03616964|183032055|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.84||0.723|TWO_SIDED|95.0|-1.95|1.35|||Mixed Models Analysis|||||1.35|-1.95|0.723
91571592|NCT03616964|183032056|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.31|1.55|||Regression, Logistic|||||1.55|0.31|0.372
91571593|NCT03616964|183032056|SUPERIORITY||Odds Ratio (OR)|0.78||||0.555|TWO_SIDED|95.0|0.34|1.78|||Regression, Logistic|||||1.78|0.34|0.555
91571594|NCT03616964|183032057|SUPERIORITY||LS Mean difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.422||0.251|TWO_SIDED|95.0|-1.31|0.34|||Mixed Models Analysis|||||0.34|-1.31|0.251
91571595|NCT03616964|183032057|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.425||0.333|TWO_SIDED|95.0|-1.74|-0.07|||Mixed Models Analysis|||||-0.07|-1.74|0.333
91571596|NCT03616964|183032058|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.282||0.284|TWO_SIDED|95.0|-0.86|0.25|||Mixed Models Analysis|||||0.25|-0.86|0.284
91571597|NCT03616964|183032058|SUPERIORITY||LS Mean difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.284||0.069|TWO_SIDED|95.0|-1.08|0.04|||Mixed Models Analysis|||||0.04|-1.08|0.069
91571598|NCT02783573|183032081|SUPERIORITY||LS Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.64||0.129|TWO_SIDED|95.0|-0.752|5.776|||Mixed Models Analysis|||||5.776|-0.752|0.129
91571599|NCT02783573|183032081|SUPERIORITY||LS Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.76||0.903|TWO_SIDED|95.0|-3.725|3.296|||Mixed Models Analysis|||||3.296|-3.725|0.903
91571600|NCT02783573|183032082|SUPERIORITY||LS Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|1.78||0.1|TWO_SIDED|95.0|-6.488|0.58|||Mixed Models Analysis|||||0.580|-6.488|0.100
91571601|NCT02783573|183032082|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|1.86||0.092|TWO_SIDED|95.0|-6.876|0.525|||Mixed Models Analysis|||||0.525|-6.876|0.092
91571602|NCT02783573|183032083|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.14||0.285|TWO_SIDED|95.0|-1.045|3.499|||Mixed Models Analysis|||||3.499|-1.045|0.285
91571603|NCT02783573|183032083|SUPERIORITY||LS Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.19||0.661|TWO_SIDED|95.0|-2.889|1.843|||Mixed Models Analysis|||||1.843|-2.889|0.661
91571604|NCT02783573|183032084|SUPERIORITY||LS Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|2.69||0.079|TWO_SIDED|95.0|-10.103|0.56|||Mixed Models Analysis|||||0.56|-10.103|0.079
91571605|NCT02783573|183032084|SUPERIORITY||LS Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|2.82||0.486|TWO_SIDED|95.0|-7.573|3.62|||Mixed Models Analysis|||||3.62|-7.573|0.486
91571606|NCT02783573|183032085|SUPERIORITY||LS Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.57||0.663|TWO_SIDED|95.0|-0.89|1.391|||Mixed Models Analysis|||||1.391|-0.890|0.663
91571607|NCT02783573|183032085|SUPERIORITY||LS Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.6||0.717|TWO_SIDED|95.0|-1.423|0.983|||Mixed Models Analysis|||||0.983|-1.423|0.717
91571608|NCT02783573|183032087|SUPERIORITY||LS Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.34||0.899|TWO_SIDED|95.0|-4.297|4.889|||Mixed Models Analysis|||||4.889|-4.297|0.899
91571609|NCT02783573|183032087|SUPERIORITY||LS Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.16||0.164|TWO_SIDED|95.0|-7.267|1.238|||Mixed Models Analysis|||||1.238|-7.267|0.164
91571610|NCT02783573|183032088|SUPERIORITY||LS Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.82||0.126|TWO_SIDED|95.0|-2.891|0.362|||Mixed Models Analysis|||||0.362|-2.891|0.126
91571611|NCT02783573|183032088|SUPERIORITY||LS Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.862|TWO_SIDED|95.0|-1.867|1.566|||Mixed Models Analysis|||||1.566|-1.867|0.862
91571612|NCT02783573|183032089|SUPERIORITY||LS Mean Difference (Final Values)|-37.55|STANDARD_ERROR_OF_MEAN|37.49||0.343|TWO_SIDED|95.0|-122.35|47.26|||ANCOVA|||||47.26|-122.35|0.343
91571613|NCT02783573|183032089|SUPERIORITY||LS Mean Difference (Final Values)|-40.72|STANDARD_ERROR_OF_MEAN|35.12||0.276|TWO_SIDED|95.0|-120.17|38.73|||ANCOVA|||||38.73|-120.17|0.276
91571614|NCT02783573|183032090|SUPERIORITY||LS Mean Difference (Final Values)|-61.94|STANDARD_ERROR_OF_MEAN|31.3||0.079|TWO_SIDED|95.0|-132.75|8.87|||ANCOVA|||||8.87|-132.75|0.079
91571615|NCT02783573|183032090|SUPERIORITY||LS Mean Difference (Final Values)|-34.15|STANDARD_ERROR_OF_MEAN|31.27||0.303|TWO_SIDED|95.0|-104.88|36.59|||ANCOVA|||||36.59|-104.88|0.303
91571616|NCT02783573|183032091|SUPERIORITY||LS Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|14.29||0.283|TWO_SIDED|95.0|-16.015|48.659|||ANCOVA|||||48.659|-16.015|0.283
91571617|NCT02783573|183032091|SUPERIORITY||LS Mean Difference (Final Values)|-13.05|STANDARD_ERROR_OF_MEAN|13.21||0.349|TWO_SIDED|95.0|-42.929|16.82|||ANCOVA|||||16.820|-42.929|0.349
91571618|NCT02783573|183032092|SUPERIORITY||LS Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.23||0.494|TWO_SIDED|95.0|-3.457|6.64|||ANCOVA|||||6.640|-3.457|0.494
91571619|NCT02783573|183032092|SUPERIORITY||LS Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|2.04||0.323|TWO_SIDED|95.0|-6.743|2.481|||ANCOVA|||||2.481|-6.743|0.323
91571620|NCT02783573|183032093|SUPERIORITY||LS Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|13.76||0.873|TWO_SIDED|95.0|-26.569|31.017|||ANCOVA|||||31.017|-26.569|0.873
91571621|NCT02783573|183032093|SUPERIORITY||LS Mean Difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|15.43||0.337|TWO_SIDED|95.0|-47.488|17.096|||ANCOVA|||||17.096|-47.488|0.337
91571622|NCT02783573|183032094|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.927|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.927
91571623|NCT02783573|183032094|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.93|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.930
91571624|NCT02783573|183032095|SUPERIORITY||LS Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|1.06||0.127|TWO_SIDED|95.0|-3.708|0.464|||ANCOVA|||||0.464|-3.708|0.127
91571625|NCT02783573|183032095|SUPERIORITY||LS Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.06||0.004|TWO_SIDED|95.0|-5.172|-0.991|||ANCOVA|||||-0.991|-5.172|0.004
91571626|NCT00656201|183032099|NON_INFERIORITY_OR_EQUIVALENCE|This was an equivalence comparison. The study was designed to detect a 14% pregnancy difference between the arms with 80% power and one interim analysis using O'Brien-Fleming parameters and an experiment-wise alpha level of 5%.|Odds Ratio (OR)|1.2|||<|0.05|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)||Crinone is the numerator and IM Progesterone is the denominator.|||1.8|0.8|<0.05
91571627|NCT01434680|183032100|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.82|||<|0.05|TWO_SIDED|95.0|0.67|1.0|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.00|0.67|<0.05
91571628|NCT01434680|183032100|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|1.14|||<|0.05|TWO_SIDED|95.0|0.92|1.41|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.41|0.92|<0.05
91571629|NCT01434680|183032101|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.72|||<|0.05|TWO_SIDED|95.0|0.58|0.89|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).||0.89|0.58|<0.05
91571630|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|3.4||||95.0|17.2|17.3||||||IOP 1 year (n=11602)||17.3|17.2|
91571631|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|2.9||||95.0|16.8|17.0||||||IOP 1 year (n=4450)||17.0|16.8|
91571632|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.3|STANDARD_DEVIATION|2.2||||95.0|17.1|17.5||||||IOP 1 year (n=357)||17.5|17.1|
91571633|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.2||||95.0|16.4|17.3||||||IOP 1 year (n=220)||17.3|16.4|
91571634|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.6|STANDARD_DEVIATION|4.1||||95.0|17.5|17.8||||||IOP 1 year (n=3277)||17.8|17.5|
91571635|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|17.0|17.1||||||IOP 2 years (n=8051)||17.1|17.0|
91571636|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|2.9||||95.0|16.7|16.9||||||IOP 2 years (n=2808)||16.9|16.7|
91571637|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|1.8||||95.0|17.0|17.5||||||IOP 2 years (n=175)||17.5|17.0|
91571638|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.6|STANDARD_DEVIATION|2.8||||95.0|15.9|17.2||||||IOP 2 years (n=83)||17.2|15.9|
91571639|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.1|STANDARD_DEVIATION|3.7||||95.0|16.9|17.2||||||IOP 2 years (n=2002)||17.2|16.9|
91571640|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|16.9|17.1||||||IOP 3 years (n=5469)||17.1|16.9|
91571641|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|3.2||||95.0|16.7|17.0||||||IOP 3 years (n=1932)||17.0|16.7|
91571642|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.5|STANDARD_DEVIATION|2.5||||95.0|16.9|18.1||||||IOP 3 years (n=64)||18.1|16.9|
91571643|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.5|STANDARD_DEVIATION|2.8||||95.0|15.7|17.4||||||IOP 3 years (n=44)||17.4|15.7|
91571644|NCT01012245|183032103|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.6||||95.0|16.7|17.1||||||IOP 3 years (n=1251)||17.1|16.7|
91571645|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 1 year (n=11966)||0.47|0.46|
91571646|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.44|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Vertical C/D ratio 1 year (n=4944)||0.44|0.43|
91571647|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.19||||95.0|0.35|0.43||||||Vertical C/D ratio 1 year (n=88)||0.43|0.35|
91571648|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.24||||95.0|0.47|0.53||||||Vertical C/D ratio 1 year (n=241)||0.53|0.47|
91571649|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Vertical C/D ratio 1 year (n=2949)||0.52|0.50|
91571650|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 2 years (n=8783)||0.47|0.46|
91571651|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.23||||95.0|0.42|0.44||||||Vertical C/D ratio 2 years (n=3396)||0.44|0.42|
91571652|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.16||||95.0|0.33|0.45||||||Vertical C/D ratio 2 years (n=31)||0.45|0.33|
91571653|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.24||||95.0|0.44|0.54||||||Vertical C/D ratio 2 years (n=95)||0.54|0.44|
91571654|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.53||||||Vertical C/D ratio 2 years (n=1934)||0.53|0.50|
91571655|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.24||||95.0|0.44|0.45||||||Vertical C/D ratio 3 years (n=6344)||0.45|0.44|
91571656|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.22||||95.0|0.41|0.43||||||Vertical C/D ratio 3 years (n=2372)||0.43|0.41|
91571657|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.33|STANDARD_DEVIATION|0.14||||95.0|0.27|0.39||||||Vertical C/D ratio 3 years (n=25)||0.39|0.27|
91571658|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.47|STANDARD_DEVIATION|0.18||||95.0|0.41|0.53||||||Vertical C/D ratio 3 years (n=36)||0.53|0.41|
91571659|NCT01012245|183032105|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.26||||95.0|0.48|0.51||||||Vertical C/D ratio 3 years (n=1283)||0.51|0.48|
91571660|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.45|0.46||||||Horizontal C/D ratio 1 year (n=11433)||0.46|0.45|
91571661|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.23||||95.0|0.42|0.43||||||Horizontal C/D ratio 1 year (n=4810)||0.43|0.42|
91571662|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.37|STANDARD_DEVIATION|0.19||||95.0|0.33|0.42||||||Horizontal C/D ratio 1 year (n=87)||0.42|0.33|
91571663|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.47|0.53||||||Horizontal C/D ratio 1 year (n=232)||0.53|0.47|
91571664|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Horizontal C/D ratio 1 year (n=2703)||0.52|0.50|
91571665|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.44|0.45||||||Horizontal C/D ratio 2 years (n=8427)||0.45|0.44|
91571666|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.41|STANDARD_DEVIATION|0.23||||95.0|0.4|0.42||||||Horizontal C/D ratio 2 years (n=3276)||0.42|0.40|
91571667|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.38|STANDARD_DEVIATION|0.19||||95.0|0.31|0.45||||||Horizontal C/D ratio 2 years (n=31)||0.45|0.31|
91571668|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.45|0.56||||||Horizontal C/D ratio 2 years (n=92)||0.56|0.45|
91571669|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.49|0.52||||||Horizontal C/D ratio 2 years (n=1812)||0.52|0.49|
91571670|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Horizontal C/D ratio 3 years (n=6102)||0.44|0.43|
91571671|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.4|STANDARD_DEVIATION|0.22||||95.0|0.39|0.41||||||Horizontal C/D ratio 3 years (n=2289)||0.41|0.39|
91571672|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.31|STANDARD_DEVIATION|0.15||||95.0|0.25|0.38||||||Horizontal C/D ratio 3 years (n=25)||0.38|0.25|
91571673|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.21||||95.0|0.42|0.57||||||Horizontal C/D ratio 3 years (n=35)||0.57|0.42|
91571674|NCT01012245|183032106|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.48|STANDARD_DEVIATION|0.26||||95.0|0.47|0.5||||||Horizontal C/D ratio 3 years (n=1204)||0.50|0.47|
91571675|NCT04836559|183032123|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3571|TWO_SIDED|95.0|0.41|1.38|||t-test, 1 sided|||||1.38|0.41|0.3571
91571676|NCT04836559|183032123|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6306|TWO_SIDED|95.0|0.4|1.75|||t-test, 1 sided|||||1.75|0.40|0.6306
91571677|NCT01952847|183032146|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
91571678|NCT01952847|183032147|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
91571679|NCT01952847|183032150|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91571680|NCT01952847|183032151|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
91571681|NCT01952847|183032152|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
91571682|NCT01952847|183032153|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91571683|NCT01952847|183032154|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
91571684|NCT01952847|183032155|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
91571685|NCT01952847|183032156|SUPERIORITY|||||||0.57|||||||Log Rank|||||||0.57
91571686|NCT01952847|183032160|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
91571687|NCT01952847|183032161|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
91571688|NCT02577003|183032168|SUPERIORITY||Difference in least squares means|-0.77|||<|0.001|TWO_SIDED|95.0|-0.98|-0.57|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.57|-0.98|<0.001
91571689|NCT02577003|183032171|SUPERIORITY||Difference in least squares means|-28.1|||<|0.001|TWO_SIDED|95.0|-34.8|-21.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-21.5|-34.8|<0.001
91571690|NCT02577003|183032172|SUPERIORITY||Difference in least squares means|-48.5|||<|0.001|TWO_SIDED|95.0|-59.6|-37.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-37.5|-59.6|<0.001
91571691|NCT02577003|183032173|SUPERIORITY||Difference in least squares means|-84.6|||<|0.001|TWO_SIDED|95.0|-102.6|-66.6|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-66.6|-102.6|<0.001
91571692|NCT02577003|183032174|SUPERIORITY||Difference in least squares means|-1.8|||<|0.001|TWO_SIDED|95.0|-2.5|-1.1|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-1.1|-2.5|<0.001
91571693|NCT01234883|183032177|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
91571694|NCT01013961|183032178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|TWO_SIDED||||||Fisher Exact|||||||0.722
91571695|NCT01013961|183032179|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
91571696|NCT01271504|183032202|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.5||||||||1.50|0.56|
91571697|NCT01271504|183032203|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.57|1.5||||||||1.50|0.57|
91571698|NCT01271504|183032205|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.62||||||||1.62|0.60|
91571699|NCT02768597|183032207|SUPERIORITY|||||||0.552|||||||ANOVA|||||||.552
91571700|NCT02768597|183032208|SUPERIORITY|||||||0.558|||||||ANOVA|||||||.558
91571701|NCT02768597|183032209|SUPERIORITY|||||||0.274|||||||Kruskal-Wallis|||||||.274
91571702|NCT02768597|183032210|SUPERIORITY|||||||0.539|||||||Kruskal-Wallis|||||||.539
91571703|NCT02768597|183032211|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||.478
91571704|NCT02768597|183032212|SUPERIORITY|||||||0.527|||||||ANOVA|||||||.527
91571705|NCT02768597|183032213|SUPERIORITY|||||||0.823|||||||ANOVA|||||||.823
91571706|NCT02768597|183032214|SUPERIORITY|||||||0.231|||||||ANOVA|||||||.231
91571707|NCT02768597|183032215|SUPERIORITY|||||||0.595|||||||Kruskal-Wallis|||||||.595
91571708|NCT02768597|183032216|SUPERIORITY|||||||0.789|||||||Kruskal-Wallis|||||||.789
91571709|NCT02402322|183032256|NON_INFERIORITY_OR_EQUIVALENCE|In the preliminary analysis, we studied the possible group differences in demographic data and pretreatment measures with chi-square tests and analysis of variance (ANOVA).||||||0.05|TWO_SIDED||||||ANOVA|||The participants' pre- and posttreatment scores were studied with repeated measures ANOVA. Within- and between-group effect sizes were calculated using the pooled standard deviation, Cohen's d.||||0.05
91571710|NCT02818998|183032265|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.01|||<|0.0001|TWO_SIDED|95.0|-1.46|1.47||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.47|-1.46|<0.0001
91571711|NCT02818998|183032265|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.95|||<|0.0001|TWO_SIDED|95.0|-0.52|2.42||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||2.42|-0.52|<0.0001
91571712|NCT02818998|183032266|OTHER||Least Square mean difference|14.38||||0.0105|TWO_SIDED|95.0|3.39|25.37|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||25.37|3.39|0.0105
91571713|NCT02818998|183032266|OTHER||Least Square mean difference|21.22||||0.0023|TWO_SIDED|95.0|7.65|34.8|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||34.80|7.65|0.0023
91571714|NCT02818998|183032267|OTHER||Treatment Difference|0.68|||||TWO_SIDED|95.0|-3.14|4.49|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.49|-3.14|
91571715|NCT02818998|183032267|OTHER||Treatment Difference|2.66|||||TWO_SIDED|95.0|-3.4|8.73|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||8.73|-3.40|
91571716|NCT02818998|183032267|OTHER||Treatment Difference|-0.66|||||TWO_SIDED|95.0|-1.94|0.63|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.63|-1.94|
91571717|NCT02818998|183032267|OTHER||Treatment Difference|-0.13|||||TWO_SIDED|95.0|-3.68|3.41|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||3.41|-3.68|
91571718|NCT02818998|183032267|OTHER||Treatment Difference|1.72|||||TWO_SIDED|95.0|-4.1|7.54|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||7.54|-4.10|
91571719|NCT02818998|183032267|OTHER||Treatment Difference|-0.68|||||TWO_SIDED|95.0|-2.0|0.65|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.65|-2.00|
91571720|NCT02818998|183032268|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-2.13|1.52|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.52|-2.13|<0.0001
91571721|NCT02818998|183032268|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|1.39|||<|0.0001|TWO_SIDED|95.0|-0.4|3.19|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||3.19|-0.40|<0.0001
91571722|NCT02818998|183032269|OTHER||Least Square mean difference|16.14||||0.0416|TWO_SIDED|95.0|0.62|31.66|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||31.66|0.62|0.0416
91571723|NCT02818998|183032269|OTHER||Least Square mean difference|4.12||||0.5524|TWO_SIDED|95.0|-9.52|17.77|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||17.77|-9.52|0.5524
91571724|NCT02818998|183032270|OTHER||Treatment Difference|0.67|||||TWO_SIDED|95.0|-2.72|4.05|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.05|-2.72|
91571725|NCT02818998|183032270|OTHER||Treatment Difference|4.63|||||TWO_SIDED|95.0|-1.73|10.98|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||10.98|-1.73|
91571726|NCT02818998|183032270|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-1.56|2.87|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.87|-1.56|
91571727|NCT02818998|183032270|OTHER||Treatment Difference|1.9|||||TWO_SIDED|95.0|-1.89|5.69|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||5.69|-1.89|
91571728|NCT02818998|183032270|OTHER||Treatment Difference|7.54|||||TWO_SIDED|95.0|0.81|14.28|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||14.28|0.81|
91571729|NCT02818998|183032270|OTHER||Treatment Difference|0.63|||||TWO_SIDED|95.0|-1.61|2.88|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.88|-1.61|
91571730|NCT02472145|183032273|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4747|TWO_SIDED|95.0|0.8|2.8|||Chi-squared|||Statistical Analysis 1||2.8|0.8|0.4747
91571731|NCT02472145|183032274|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7817|TWO_SIDED|95.0|0.79|1.37|||Log Rank|||Statistical Analysis 1||1.37|0.79|0.7817
91571732|NCT00632021|183032285|EQUIVALENCE|In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.|Incidence Rate Ratio (IRR)|0.92|||||TWO_SIDED|95.0|0.77|1.09||||||||1.09|0.77|
91571733|NCT00632021|183032286|EQUIVALENCE|The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.|Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.63|1.28||||||||1.28|0.63|
91571734|NCT03563313|183032287|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91571735|NCT03563313|183032288|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91571736|NCT03563313|183032289|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91571737|NCT03563313|183032290|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
91571738|NCT03563313|183032291|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91571739|NCT03563313|183032292|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
91571740|NCT02250534|183032336|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
91571741|NCT02250534|183032336|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 6.07 CPD between the 0.8 mg and 0.03 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
91571742|NCT01587118|183032352|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||<.0001
91571743|NCT01587118|183032353|SUPERIORITY_OR_OTHER|||||||0.0006||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||.0006
91571744|NCT00537329|183032354|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.1||||||95.0|70.5|95.3||||||Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.||95.3|70.5|
91571745|NCT00537329|183032355|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.2||||||95.0|74.6|97.0||||||EOIT||97.0|74.6|
91571746|NCT00537329|183032355|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|82.8||||||95.0|64.2|94.2||||||2 Wks post EOT||94.2|64.2|
91571747|NCT00537329|183032355|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.5||||||95.0|66.9|98.7||||||6 Wks post EOT||98.7|66.9|
91571748|NCT00537329|183032355|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.7||||||95.0|49.8|89.3||||||12 Wks post baseline||89.3|49.8|
91571749|NCT00537329|183032356|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOIT: success (cure/improvement)||99.9|85.1|
91571750|NCT00537329|183032356|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.1||||||95.0|80.3|99.3||||||EOT: success (cure/improvement)||99.3|80.3|
91571751|NCT00537329|183032356|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|92.9||||||95.0|76.5|99.1||||||2 Wks post EOT: success (cure/improvement)||99.1|76.5|
91571752|NCT00537329|183032356|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (cure/improvement)||99.9|72.7|
91571753|NCT00537329|183032356|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|85.0||||||95.0|62.1|96.8||||||12 Wks post baseline: success (cure/improvement)||96.8|62.1|
91571754|NCT00537329|183032357|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.3||||||95.0|85.8|99.9||||||EOIT: success (erad/presumed erad)||99.9|85.8|
91571755|NCT00537329|183032357|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOT: success (erad/presumed erad)||99.9|85.1|
91571756|NCT00537329|183032357|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.2||||||95.0|68.3|96.1||||||2 Wks post EOT: success (erad/presumed erad)||96.1|68.3|
91571757|NCT00537329|183032357|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (erad/presumed erad)||99.9|72.7|
91571758|NCT00537329|183032357|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.2||||||95.0|60.4|96.6||||||12 Wks post baseline: success (erad/presumed erad)||96.6|60.4|
91571759|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|50.0||||||95.0|1.3|98.7||||||Neutropenic status: ANC ≤ 500/cmm||98.7|1.3|
91571760|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|75.7||||||95.0|58.8|88.2||||||Neutropenic status: ANC \> 500/cmm||88.2|58.8|
91571761|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|41.9|91.6||||||Baseline pathogen: Candida albicans||91.6|41.9|
91571762|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|66.7||||||95.0|22.3|95.7||||||Baseline pathogen: Candida glabrata||95.7|22.3|
91571763|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|39.8|100.0||||||Baseline pathogen: Candida parapsilosis||100.0|39.8|
91571764|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|2.5|100.0||||||Baseline pathogen: Candida rugosa||100.0|2.5|
91571765|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.2||||||95.0|46.5|90.3||||||Baseline pathogen: Candida tropicalis||90.3|46.5|
91571766|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.6||||||95.0|54.6|98.1||||||Previous surgery: Any surgery||98.1|54.6|
91571767|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|87.5||||||95.0|47.3|99.7||||||Previous surgery: Abdominal surgery||99.7|47.3|
91571768|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|58.8||||||95.0|32.9|81.6||||||Elderly: Age ≥ 65 years||81.6|32.9|
91571769|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|54.5||||||95.0|23.4|83.3||||||Renal insufficiency (CCC \< 30 mL/min)||83.3|23.4|
91571770|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|81.0||||||95.0|58.1|94.6||||||Use of Central venous catheter = Yes||94.6|58.1|
91571771|NCT00537329|183032364|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|29.0|96.3||||||Receiving chemotherapy = Yes||96.3|29.0|
91571772|NCT01653210|183032365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||||||0.023
91571773|NCT00243022|183032367|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.9
91571774|NCT00243022|183032368|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
91571775|NCT00243022|183032369|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.8
91571776|NCT03042299|183032388|EQUIVALENCE|The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0731|||||TWO_SIDED|90.0|-0.1088|-0.0373||||||||-0.0373|-0.1088|
91571777|NCT03042299|183032389|EQUIVALENCE|The difference in the LS means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0909|||||TWO_SIDED|90.0|-0.1573|-0.0244||||||||-0.0244|-0.1573|
91571778|NCT02353871|183032411|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
91571779|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 8 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
91571780|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 15 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
91571781|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 57 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
91571782|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 85 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
91571783|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 113 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
91571784|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 148 - BTX-A-HAC NG solution (50 U) versus placebo||||0.0035
91571785|NCT02353871|183032412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0441||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 183 (End of Study) - BTX-A-HAC NG solution (50 U) versus placebo||||0.0441
91571786|NCT02353871|183032413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2422||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 57 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.2422
91571787|NCT02353871|183032413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 85 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.0917
91571788|NCT02353871|183032413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7064||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 113 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7064
91571789|NCT02353871|183032413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 148 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7010
91571790|NCT02353871|183032413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7894||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 183 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7894
91571791|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
91571792|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
91571793|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
91571794|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
91571795|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
91571796|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
91571797|NCT02353871|183032414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0015
91571798|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
91571799|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
91571800|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
91571801|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
91571802|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||0.0008
91571803|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||0.0065
91571804|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0643||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0643
91571805|NCT02353871|183032415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.3670
91571806|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
91571807|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
91571808|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
91571809|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
91571810|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - Dysport 50 U versus Placebo at Day 85||||<0.0001
91571811|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
91571812|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0011
91571813|NCT02353871|183032416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0036||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0036
91571814|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
91571815|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
91571816|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
91571817|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
91571818|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
91571819|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
91571820|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||<0.0001
91571821|NCT02353871|183032417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||<0.0001
91571822|NCT02353871|183032418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus Placebo||||<0.0001
91571823|NCT02353871|183032418|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.561|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|Centre, gender and ILA baseline severity score used as covariates.||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
91571824|NCT02554383|183032428|SUPERIORITY|||||||0.02||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (2).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of pathogens in the nasopharynx at enrollment, i.e., there is no significant interaction between treatment and pathogens in the nasopharynx.||||0.02
91571825|NCT02554383|183032428|SUPERIORITY||Difference of least-squares means|-1.95|||||TWO_SIDED|95.0|-2.4|-1.51|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of one or more pathogens in the nasopharynx at enrollment.||-1.51|-2.40|
91571826|NCT02554383|183032428|SUPERIORITY||Difference of least-squares means|-0.88|||||TWO_SIDED|95.0|-1.63|-0.12|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of one or more pathogens in the nasopharynx at enrollment.||-0.12|-1.63|
91571827|NCT02554383|183032429|SUPERIORITY|||||||0.37||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (1).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of colored nasal discharge at enrollment, i.e., there is no significant interaction between treatment and colored nasal discharge.||||0.37
91571828|NCT02554383|183032429|SUPERIORITY||Difference of least-squares means|-1.62|||||TWO_SIDED|95.0|-2.09|-1.16|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of colored nasal discharge at enrollment.||-1.16|-2.09|
91571829|NCT02554383|183032429|SUPERIORITY||Difference of least-squares means|-1.7|||||TWO_SIDED|95.0|-2.38|-1.03|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of colored nasal discharge at enrollment.||-1.03|-2.38|
91571830|NCT02554383|183032430|SUPERIORITY|||||||0.003|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children experiencing treatment failure.||||0.003
91571831|NCT02554383|183032431|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Null hypothesis: There is no difference between the treatment groups in the proportion of children developing AOM over the first 10 days of follow-up.||||.007
91571832|NCT02554383|183032432|SUPERIORITY||||||<|0.001|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children receiving a systemic antibiotic over the first 10 days of follow-up.||||<0.001
91571833|NCT02554383|183032433|SUPERIORITY|||||||0.004|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children for whom diarrhea or generalized rash was reported.||||0.004
91571834|NCT02554383|183032434|SUPERIORITY|||||||0.75|||||||Log-binomial regression|The p-value is adjusted for presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children compliant with study product.||||0.75
91571835|NCT02554383|183032435|SUPERIORITY|||||||0.63|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children with a nonsusceptible pathogen at the follow-up visit.||||0.63
91571836|NCT02911805|183032468|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91571837|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.99|||||TWO_SIDED|95.0|0.65|1.52||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.52|0.65|
91571838|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|2.11|||||TWO_SIDED|95.0|1.5|2.98||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.98|1.5|
91571839|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.68|||||TWO_SIDED|95.0|0.43|1.06||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.06|0.43|
91571840|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.87|0.58|
91571841|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.0|||||TWO_SIDED|95.0|0.92|1.08||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.08|0.92|
91571842|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||1.01|0.6|
91571843|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.27|||||TWO_SIDED|95.0|0.83|1.96||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.96|0.83|
91571844|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|1.6|||||TWO_SIDED|95.0|1.13|2.28||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.28|1.13|
91571845|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.52|||||TWO_SIDED|95.0|0.33|0.81||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||0.81|0.33|
91571846|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.78|0.52|
91571847|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.04|0.89|
91571848|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.49|0.84||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.84|0.49|
91571849|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.02|||||TWO_SIDED|95.0|0.66|1.58||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.58|0.66|
91571850|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|1.62|||||TWO_SIDED|95.0|1.14|2.3||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.3|1.14|
91571851|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.74|||||TWO_SIDED|95.0|0.47|1.17||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.17|0.47|
91571852|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.46|||||TWO_SIDED|95.0|0.38|0.57||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.57|0.38|
91571853|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.94|||||TWO_SIDED|95.0|0.87|1.02||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.02|0.87|
91571854|NCT02035696|183032479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.57|||||TWO_SIDED|95.0|0.44|0.75||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.75|0.44|
91571855|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|0.0|18.9||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||18.9|0|
91571856|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||8|-4|
91571857|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-11.0|||||TWO_SIDED|95.0|-21.1|-1.5||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1.5|-21.1|
91571858|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|7.0|||||TWO_SIDED|95.0|-2.5|16.8||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||16.8|-2.5|
91571859|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-3.0|||||TWO_SIDED|95.0|-9.5|4.1||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||4.1|-9.5|
91571860|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-20.5|-1.0||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1|-20.5|
91571861|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|6.0|||||TWO_SIDED|95.0|-4.2|15.4||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||15.4|-4.2|
91571862|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-6.0|||||TWO_SIDED|95.0|-13.4|1.3||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||1.3|-13.4|
91571863|NCT02035696|183032480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-18.0|||||TWO_SIDED|95.0|-27.8|-7.2||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-7.2|-27.8|
91571864|NCT02035696|183032481|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
91571865|NCT02035696|183032481|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
91571866|NCT02035696|183032481|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
91571867|NCT00379769|183032491|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication|Hazard Ratio (HR)|0.99||||||95.0|0.85|1.16||||||||1.16|0.85|
91571868|NCT00379769|183032515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||||95.0|0.68|1.08||||||||1.08|0.68|
91571869|NCT00379769|183032516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.78|1.17||||||||1.17|0.78|
91571870|NCT00379769|183032517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.79|1.18||||||||1.18|0.79|
91571871|NCT00379769|183032518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
91571872|NCT00379769|183032519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
91571873|NCT00379769|183032520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||||95.0|0.8|1.59||||||||1.59|0.80|
91571874|NCT00379769|183032521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||||95.0|0.82|1.62||||||||1.62|0.82|
91571875|NCT00379769|183032522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||||95.0|0.54|1.14||||||||1.14|0.54|
91571876|NCT00379769|183032523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.57|1.18||||||||1.18|0.57|
91571877|NCT04546217|183032554|SUPERIORITY|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
91571878|NCT04546217|183032555|OTHER|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
91571879|NCT04546217|183032556|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
91571880|NCT04546217|183032557|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
91571881|NCT04546217|183032558|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
91571882|NCT04546217|183032559|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
91571883|NCT03121820|183032593|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|93.8||||0.05|TWO_SIDED|90.0|88.25|99.77|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||99.77|88.25|0.05
91571884|NCT03121820|183032594|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|92.3||||0.05|TWO_SIDED|90.0|86.37|98.55|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||98.55|86.37|0.05
91571885|NCT01245140|183032595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5731||||0.9705|TWO_SIDED|95.0|-30.9738|32.12|||ANCOVA|||||32.1200|-30.9738|0.9705
91571886|NCT01245140|183032596|SUPERIORITY_OR_OTHER|||||||0.4564||95.0||||PPPASI 50 response|Fisher Exact|||||||0.4564
91571887|NCT01245140|183032596|SUPERIORITY_OR_OTHER|||||||0.6595||95.0||||PPPASI 75 response|Fisher Exact|||||||0.6595
91571888|NCT01245140|183032598|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||Change in Total Pustule Count: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.51
91571889|NCT01245140|183032599|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Relative change in mPASI score: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.12
91571890|NCT01245140|183032600|SUPERIORITY_OR_OTHER||Least squared estimation|49.4927||||0.2358|TWO_SIDED|95.0|-49.083|148.07|||ANCOVA|||||148.07|-49.0830|0.2358
91571891|NCT01245140|183032601|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 50 response|Fisher Exact|||||||0.1667
91571892|NCT01245140|183032601|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 75 response|Fisher Exact|||||||0.1667
91571893|NCT04082429|183032631|SUPERIORITY|Bleeding endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as offset with treatment and bleeding frequency prior to screening as factors.|ABR ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.07|0.29|||Negative binomial regression|||||0.29|0.07|<0.001
91571894|NCT04082429|183032632|SUPERIORITY|Bleeding endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as offset with treatment and bleeding frequency prior to screening as factors.|ABR ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.45|||Negative binomial regression|||||0.45|0.10|<0.001
91571895|NCT03118050|183032658|OTHER||||||<|0.01||||||Main effect of bed rest.|ANOVA|||||||<0.01
91571896|NCT03118050|183032659|OTHER||||||<|0.01||||||Main effect of bed rest|ANOVA|||||||<0.01
91571897|NCT02980523|183032691|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.002|||||||Chi-squared|||||||0.002
91571898|NCT02980523|183032692|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.372|||||||Chi-squared, Corrected|||||||0.372
91571899|NCT02980523|183032693|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.341|||||||Chi-squared, Corrected|||||||0.341
91571900|NCT02980523|183032694|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.001|||||||Chi-squared, Corrected|||||||0.001
91571901|NCT02980523|183032695|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.003|||||||Chi-squared, Corrected|||||||0.003
91571902|NCT02980523|183032696|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.216|||||||Chi-squared, Corrected|||||||0.216
91571903|NCT02980523|183032697|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.829|||||||Chi-squared, Corrected|||||||0.829
91571904|NCT04560374|183032743|EQUIVALENCE|Power analysis was performed after the completion of the study. 98% power was obtained.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91571905|NCT00420784|183032780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.23|||<|0.001|TWO_SIDED|95.0|4.14|16.36|||Regression, Logistic|||||16.36|4.14|<0.001
91571906|NCT00420784|183032780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.52|||<|0.001|TWO_SIDED|95.0|4.72|19.2|||Regression, Logistic|||||19.20|4.72|<0.001
91571907|NCT00420784|183032780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31||||0.024|TWO_SIDED|95.0|1.12|4.75|||Regression, Logistic|||||4.75|1.12|0.024
91571908|NCT00420784|183032782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|3.41|12.96|||Regression, Logistic|||||12.96|3.41|<0.001
91571909|NCT00420784|183032782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.72|||<|0.001|TWO_SIDED|95.0|2.91|11.27|||Regression, Logistic|||||11.27|2.91|<0.001
91571910|NCT00420784|183032782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.067|TWO_SIDED|95.0|0.95|4.0|||Regression, Logistic|||||4.00|0.95|0.067
91571911|NCT00443209|183032792|SUPERIORITY_OR_OTHER||Treatment Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-10.4|-2.6|||Miettenen and Nurminen method||Treatment Difference was compared using the Miettinen and Nurminen (MN) method.|||-2.6|-10.4|<0.001
91571912|NCT00443209|183032793|SUPERIORITY_OR_OTHER||Treatment Difference|-5.2|||||TWO_SIDED|95.0|-11.7|1.4|||||Treatment Difference was compared using the MN method.|||1.4|-11.7|
91571913|NCT00443209|183032794|SUPERIORITY_OR_OTHER||Treatment Difference|0.3|||||TWO_SIDED|95.0|-2.0|2.0|||||Treatment Difference was compared using the MN method.|||2.0|-2.0|
91571914|NCT00443209|183032796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||Based on mixed logistic regression model with a fixed effect term for treatment, baseline pain severity and a random effect term for participant, with the random effect following a normal distribution. An odds ratio \>1 is in favor of telcagepant.|||0.75|0.45|
91571915|NCT03636373|183032842|NON_INFERIORITY|On a 10 point Likert Pain Scale, non-inferiority margin for the difference is 1.04. Using a Student t-test, there was 80% power for the difference in pain levels to exceed -1.04.||||||1|||||||t-test, 1 sided|||Mean Outcome measure Etanercept arm { ( 8 + 0 + 7)/3 = 5} Triamcinolone Arm { (3+0) /2 = 1.5 }||||1.00
91571916|NCT03636373|183032843|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
91571917|NCT03636373|183032844|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91571918|NCT03636373|183032845|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91571919|NCT03636373|183032846|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
91571920|NCT03636373|183032847|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91571921|NCT01575873|183032848|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -1.1 percentage points for the glucocorticoid-initiating subpopulation.|LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.|ANCOVA||Least Squares (LS) Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction."||3.9|2.0|< 0.001
91571922|NCT01575873|183032848|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -0.7 percentage points for the glucocorticoid-continuing subpopulation.|LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
91571923|NCT01575873|183032849|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.0|< 0.001
91571924|NCT01575873|183032849|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
91571925|NCT01575873|183032850|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|0.8|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||2.1|0.8|< 0.001
91571926|NCT01575873|183032850|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|1.0|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||2.1|1.0|< 0.001
91571927|NCT01575873|183032851|SUPERIORITY||LS Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|3.2|5.8||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||5.8|3.2|< 0.001
91571928|NCT01575873|183032851|SUPERIORITY||LS Mean Difference|3.2|||<|0.001|TWO_SIDED|95.0|2.0|4.3||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||4.3|2.0|< 0.001
91571929|NCT01575873|183032852|SUPERIORITY||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.2|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.2|< 0.001
91571930|NCT01575873|183032852|SUPERIORITY||LS Mean Difference|2.5|||<|0.001|TWO_SIDED|95.0|1.7|3.2||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.2|1.7|< 0.001
91571931|NCT03698019|183032877|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.004|TWO_SIDED||||||Log Rank|||||||0.004
91571932|NCT02647645|183032882|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.02||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = 1.78).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.||||0.02
91571933|NCT02647645|183032883|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.34||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .71).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.34
91571934|NCT02647645|183032884|SUPERIORITY|Power calculation was based on the investigators' estimate of the impact of cognitive training with transcranial direct current stimulation (tDCS) on subjective cognitive problems, as similar studies were not available to develop effect size estimates.||||||0.33||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .63).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.33
91571935|NCT04599907|183032894|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
91571936|NCT04599907|183032895|SUPERIORITY||Mean Difference (Final Values)|-0.91|||<|0.05|TWO_SIDED|95.0|-1.42|-0.04|||Mixed Models Analysis|||"This is the data for the Level of Botherstatistical analysis"||-0.040|-1.42|<0.05
91571937|NCT04599907|183032895|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.05|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||"This is the data for the Level of Impact on Daily Activities Statistical Analysis"||-0.40|-1.35|<0.05
91571938|NCT02272244|183032932|SUPERIORITY||Odds Ratio (OR)|4.83|||<|0.001|TWO_SIDED|95.0|3.08|7.58|||Regression, Logistic|Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage||||7.58|3.08|<0.001
91571939|NCT02272244|183032933|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.55|9.47|||Regression, Logistic|Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.||||9.47|2.55|<0.001
91571940|NCT02272244|183032934|SUPERIORITY||||||<|0.001|||||||Regression, Multinomial|Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.|||<0.001
91571941|NCT02272244|183032934|SUPERIORITY||Odds Ratio (OR)|4.2||||0.001|TWO_SIDED|95.0|2.63|6.7|||Odds Ratio (OR)|Stool Blood Test vs None||||6.70|2.63|0.001
91571942|NCT02272244|183032934|SUPERIORITY|Colonscopy vs None|Odds Ratio (OR)|8.79||||0.001|TWO_SIDED|95.0|4.13|18.74|||Odds Ratio (OR)|||||18.74|4.13|0.001
91571943|NCT02272244|183032935|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.862|TWO_SIDED|95.0|-0.15|0.13|||Regression, Linear|Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.|Model compares DSNI to SI.|||0.13|-0.15|0.862
91571944|NCT02272244|183032935|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.47|0.55|||Regression, Linear|Model of knowledge test score adjusts for all baseline covariates|Model compares DSNI to SI.|||.55|-.47|0.880
91571945|NCT03733899|183032949|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|4.96|||TWO_SIDED|95.0|-7.3|12.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||12.4|-7.3|
91571946|NCT03733899|183032949|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-9.6|11.5|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||11.5|-9.6|
91571947|NCT03733899|183032949|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-8.2|9.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||9.8|-8.2|
91571948|NCT03733899|183032949|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-6.5|12.2|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||12.2|-6.5|
91571949|NCT03733899|183032949|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|4.37|||TWO_SIDED|95.0|-5.7|11.7|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||11.7|-5.7|
91571950|NCT03733899|183032949|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-1.4|16.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||16.8|-1.4|
91571951|NCT03733899|183032950|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|95.0|-10.3|14.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||14.4|-10.3|
91571952|NCT03733899|183032950|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.1|12.9|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||12.9|-12.1|
91571953|NCT03733899|183032950|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.4|12.1|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||12.1|-11.4|
91571954|NCT03733899|183032950|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-9.2|14.0|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||14.0|-9.2|
91571955|NCT03733899|183032950|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-8.5|14.3|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||14.3|-8.5|
91571956|NCT03733899|183032950|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-3.7|18.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||18.8|-3.7|
91571957|NCT03733899|183032951|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.61|||TWO_SIDED|95.0|-13.2|5.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|5.1|-13.2|
91571958|NCT03733899|183032951|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|4.85|||TWO_SIDED|95.0|-13.9|5.3|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|5.3|-13.9|
91571959|NCT03733899|183032951|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|4.04|||TWO_SIDED|95.0|-24.4|-8.3|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-8.3|-24.4|
91571960|NCT03733899|183032951|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-17.8|-1.4|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|-1.4|-17.8|
91571961|NCT03733899|183032951|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-20.6|-4.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-4.1|-20.6|
91571962|NCT03733899|183032951|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-16.7|0.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|0.2|-16.7|
91571963|NCT03733899|183032952|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.07|||TWO_SIDED|95.0|-8.7|11.6|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|11.6|-8.7|
91571964|NCT03733899|183032952|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|18.0|-1.0|
91571965|NCT03733899|183032952|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-3.5|17.0|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|17.0|-3.5|
91571966|NCT03733899|183032952|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|4.82|||TWO_SIDED|95.0|1.6|20.8|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|20.8|1.6|
91571967|NCT03733899|183032953|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|6.12|||TWO_SIDED|95.0|-11.4|12.9|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 10-mintues post treatment - Pre Treatment.|12.9|-11.4|
91571968|NCT03733899|183032953|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-4.9|19.9|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 5-mintues post treatment - Pre Treatment.|19.9|-4.9|
91571969|NCT03733899|183032953|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.19|||TWO_SIDED|95.0|-9.3|15.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 10-mintues post treatment - Pre Treatment.|15.2|-9.3|
91571970|NCT03733899|183032953|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-4.9|19.6|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 5-mintues post treatment - Pre Treatment.|19.6|-4.9|
91571971|NCT03733899|183032954|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|-12.4|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-20.9|-3.9|||Mixed Models Analysis||||mean difference was calculated as postremoval minus pre-insertion with Test and corneal region.|-3.9|-20.9|
91571972|NCT00667459|183032967|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.032||||0.995|TWO_SIDED|95.0|-0.07|0.134||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.134|-0.070|0.995
91571973|NCT00667459|183032967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.736
91571974|NCT00667459|183032968|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.048||||1|TWO_SIDED|95.0|-0.02|0.118||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint."||0.118|-0.020|1.0
91571975|NCT00667459|183032968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.912
91571976|NCT00667459|183032969|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.099||||1|TWO_SIDED|95.0|0.038|0.161||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.161|0.038|1.0
91571977|NCT00667459|183032969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.999
91571978|NCT00667459|183032970|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.034||||0.992|TWO_SIDED|95.0|-0.085|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.085|0.992
91571979|NCT00667459|183032970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.097||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.097
91571980|NCT00667459|183032971|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.043|0.023||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.023|-0.043|1.0
91571981|NCT00667459|183032971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.273
91571982|NCT00667459|183032972|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.019||||1|TWO_SIDED|95.0|-0.018|0.058||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.058|-0.018|1.0
91571983|NCT00667459|183032972|SUPERIORITY_OR_OTHER_LEGACY|||||||0.845||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.845
91571984|NCT00667459|183032973|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.047||||0.936|TWO_SIDED|95.0|-0.113|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.113|0.936
91571985|NCT00667459|183032974|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.105||||1|TWO_SIDED|95.0|0.02|0.19||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.190|0.020|1.0
91571986|NCT00667459|183032974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.992
91571987|NCT00667459|183032976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the operative time in two treatment groups was assessed.||||0.013
91571988|NCT00667459|183032977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.769||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the blood loss in two treatment groups was assessed.||||0.769
91571989|NCT00667459|183032978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the hospital stay in two treatment groups was assessed.||||0.273
91571990|NCT00078377|183032991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0024||95.0|1.02|4.61|||ANCOVA|The corresponding baseline value as a covariate.||Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group||4.61|1.02|0.0024
91571991|NCT00078377|183032992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91571992|NCT00581893|183032993|SUPERIORITY|||||||0.5|||||||McNemar|||||||0.50
91571993|NCT01381575|183032994|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.08|0.78||||||Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.78|-1.08|
91571994|NCT01381575|183032994|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.0|0.77||||||Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.77|-1.00|
91571995|NCT01381575|183032995|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|1.09|||||TWO_SIDED|95.0|0.97|1.22||||||Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||1.22|0.97|
91571996|NCT01381575|183032995|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.76|0.95||||||Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.95|0.76|
91571997|NCT01920932|183033036|SUPERIORITY||Binomial proportions|31.25|||||TWO_SIDED|90.0||||The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.||||In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.||||
91571998|NCT01920932|183033038|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).||||0.004
91571999|NCT01920932|183033039|SUPERIORITY|||||||0.0008|||||||Log Rank|||The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.||||0.0008
91572000|NCT01920932|183033044|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
91572001|NCT01920932|183033044|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.002
91572002|NCT01920932|183033044|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.067
91572003|NCT01920932|183033044|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.115
91572004|NCT01920932|183033044|SUPERIORITY|||||||0.455|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.455
91572005|NCT01920932|183033044|SUPERIORITY|||||||0.636|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T4, completion of radiation (approximately 8 months)||||0.636
91572006|NCT01920932|183033044|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
91572007|NCT01920932|183033044|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
91572008|NCT01920932|183033044|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T4, completion of radiation (approximately 8 months)||||0.006
91572009|NCT01920932|183033044|SUPERIORITY|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.099
91572010|NCT01920932|183033044|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.050
91572011|NCT01920932|183033044|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T4, completion of radiation (approximately 8 months)||||0.520
91572012|NCT01920932|183033044|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.024
91572013|NCT01920932|183033044|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.011
91572014|NCT01920932|183033044|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T4, completion of radiation (approximately 8 months)||||0.009
91572015|NCT01920932|183033044|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
91572016|NCT01920932|183033044|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
91572017|NCT01920932|183033044|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T4, completion of radiation (approximately 8 months)||||0.035
91572018|NCT01920932|183033044|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.037
91572019|NCT01920932|183033044|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.043
91572020|NCT01920932|183033044|SUPERIORITY|||||||0.044|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T4, completion of radiation (approximately 8 months)||||0.044
91572021|NCT01920932|183033044|SUPERIORITY|||||||0.091|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.091
91572022|NCT01920932|183033044|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.248
91572023|NCT01920932|183033044|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T4, completion of radiation (approximately 8 months)||||0.069
91572024|NCT01920932|183033044|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.010
91572025|NCT01920932|183033044|SUPERIORITY|||||||0.292|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.292
91572026|NCT01920932|183033044|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T4, completion of radiation (approximately 8 months)||||0.429
91572027|NCT01920932|183033045|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)||||0.975
91572028|NCT01920932|183033045|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.032
91572029|NCT01920932|183033045|SUPERIORITY|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.497
91572030|NCT01920932|183033045|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.399
91572031|NCT01920932|183033045|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)||||0.451
91572032|NCT01920932|183033045|SUPERIORITY|||||||0.198|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.198
91572033|NCT01920932|183033045|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.967
91572034|NCT01920932|183033045|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)||||0.647
91572035|NCT01920932|183033045|SUPERIORITY|||||||0.145|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)||||0.145
91572036|NCT01920932|183033045|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
91572037|NCT01920932|183033045|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.073
91572038|NCT01920932|183033045|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)||||0.156
91572039|NCT01920932|183033045|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T1, At Diagnosis (baseline)||||0.844
91572040|NCT01920932|183033045|SUPERIORITY|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.206
91572041|NCT01920932|183033045|SUPERIORITY|||||||0.491|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.491
91572042|NCT01920932|183033045|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T4, completion of radiation (approximately 8 months)||||0.906
91572043|NCT01920932|183033045|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T1, At Diagnosis (baseline)||||0.580
91572044|NCT01920932|183033045|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.012
91572045|NCT01920932|183033045|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.010
91572046|NCT01920932|183033045|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T4, completion of radiation (approximately 8 months)||||0.005
91572047|NCT04486313|183033066|SUPERIORITY|||||||0.8786|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.8786
91572048|NCT04486313|183033067|SUPERIORITY|||||||0.074||||||Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness|Cochran-Mantel-Haenszel|||||||0.0740
91572049|NCT04486313|183033068|SUPERIORITY|||||||0.4479|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 4||||0.4479
91572050|NCT04486313|183033068|SUPERIORITY|||||||0.2814|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 10||||0.2814
91572051|NCT04486313|183033069|SUPERIORITY|||||||0.0665|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 4||||0.0665
91572052|NCT04486313|183033069|SUPERIORITY|||||||0.4974|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 10||||0.4974
91572053|NCT04486313|183033070|SUPERIORITY|||||||0.1771|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.1771
91572054|NCT04486313|183033071|SUPERIORITY|||||||0.2399|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.2399
91572055|NCT04486313|183033072|SUPERIORITY|||||||0.09|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.09
91572056|NCT04486313|183033073|SUPERIORITY|||||||0.0077|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.0077
91572057|NCT04486313|183033074|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
91572058|NCT04486313|183033075|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
91572059|NCT04486313|183033076|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.08
91572060|NCT01375751|183033108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.82|STANDARD_ERROR_OF_MEAN|3.92|<|0.001|TWO_SIDED|95.0|-51.56|-36.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference.|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-36.09|-51.56|<0.001
91572061|NCT01375751|183033108|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.36|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-64.06|-48.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-48.67|-64.06|<0.001
91572062|NCT01375751|183033109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-79.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-51.4|-79.6|<0.001
91572063|NCT01375751|183033109|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-84.7|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-98.8|-70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-70.7|-98.8|<0.001
91572064|NCT01375751|183033110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.79|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-49.32|-34.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-34.26|-49.32|<0.001
91572065|NCT01375751|183033110|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.46|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-60.95|-45.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-45.97|-60.95|<0.001
91572066|NCT01375751|183033111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|3.55|<|0.001|TWO_SIDED|95.0|-41.77|-27.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.74|-41.77|<0.001
91572067|NCT01375751|183033111|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.2|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-53.18|-39.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-39.23|-53.18|<0.001
91572068|NCT01375751|183033112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.66|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-44.01|-29.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placbo is the reference|||-29.32|-44.01|<0.001
91572069|NCT01375751|183033112|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.01|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-52.32|-37.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.70|-52.32|<0.001
91572070|NCT01375751|183033113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.92|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-40.72|-27.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.11|-40.72|<0.001
91572071|NCT01375751|183033113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.64|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-51.41|-37.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.86|-51.41|<0.001
91572072|NCT00882115|183033123|OTHER||||||<|0.001|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.||||<0.001
91572073|NCT00882115|183033123|OTHER||||||<|0.01|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.||||<0.01
91572074|NCT02552147|183033124|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||.44
91572075|NCT02552147|183033125|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.38
91572076|NCT02552147|183033129|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
91572077|NCT02552147|183033130|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
91572078|NCT02552147|183033131|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.50
91572079|NCT02552147|183033132|SUPERIORITY|||||||1||||||P value was calculated to \>0.99 and thus rounded to 1.0.|Wilcoxon (Mann-Whitney)|Two-tailed||||||1.0
91572080|NCT02552147|183033133|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.25
91572081|NCT02552147|183033134|SUPERIORITY|||||||0.69|||||||Binomial test|||||||0.69
91572082|NCT00940875|183033136|SUPERIORITY_OR_OTHER||Difference in Response Rates|-3.3|||||TWO_SIDED|95.0|-17.5|10.9|||||The 95% CI for the difference of 2 rates was estimated using the Hauck-Anderson method.|||10.9|-17.5|
91572083|NCT00940875|183033137|SUPERIORITY_OR_OTHER|||||||0.4798|TWO_SIDED||||||Log Rank|||Difference between treatment groups in PFS||||0.4798
91572084|NCT00940875|183033137|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.3||||0.4805|TWO_SIDED|95.0|0.63|2.68|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), disease stage, histology, and smoking status.|||2.68|0.63|0.4805
91572085|NCT00940875|183033138|SUPERIORITY_OR_OTHER||Difference in Response Rates|-11.54|||||TWO_SIDED|95.0|-40.3|17.2|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 8||17.2|-40.3|
91572086|NCT00940875|183033138|SUPERIORITY_OR_OTHER||Difference in Response Rates|-13.46|||||TWO_SIDED|95.0|-36.0|9.0|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 16||9.0|-36.0|
91572087|NCT00940875|183033140|SUPERIORITY_OR_OTHER|||||||0.5393|TWO_SIDED||||||Log Rank|||Difference between treatment groups in OS||||0.5393
91572088|NCT00940875|183033140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.5399|TWO_SIDED|95.0|0.38|1.66|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by ECOG PS, disease stage, histology, and smoking status.|||1.66|0.38|0.5399
91572089|NCT05186311|183033162|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit (CAL).||||||||||||||||One hundred (100) participants (with paired numerical data) per each analyte provide \> 90% power to ensure that mean biases and confidence intervals are within the clinical acceptance limit (CAL), at medically relevant points, assuming no true bias between the tube types, residual standard deviation (SD) or coefficient of variation (CV) = CAL and collected data cover medically relevant points.|"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572090|NCT05186311|183033163|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572091|NCT05186311|183033164|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572092|NCT05186311|183033165|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572093|NCT05186311|183033166|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572094|NCT05186311|183033167|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572095|NCT05186311|183033168|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572096|NCT05186311|183033169|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572097|NCT05186311|183033170|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572098|NCT05186311|183033171|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572099|NCT05186311|183033172|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572100|NCT05186311|183033173|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
91572101|NCT01607879|183033208|SUPERIORITY|||||||0.1497|||||||t-test, 1 sided|||||||0.1497
91572102|NCT01607879|183033209|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
91572103|NCT01607879|183033210|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
91572104|NCT01607879|183033211|SUPERIORITY|||||||0.925|||||||Wilcoxon (Mann-Whitney)|||||||0.925
91572105|NCT01607879|183033212|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
91572106|NCT00513747|183033278|SUPERIORITY|||||||0.1521|||||||Log Rank|||||||0.1521
91572107|NCT00513747|183033279|SUPERIORITY|||||||0.0097|||||||Log Rank|||||||0.0097
91572108|NCT00513747|183033280|SUPERIORITY|||||||0.4645|||||||Log Rank|||||||0.4645
91572109|NCT00855413|183033318|OTHER|one sided ANOVA.|Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|0.15||0.03|TWO_SIDED|||||The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.|ANOVA|||An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.||||0.03
91572110|NCT00855413|183033320|OTHER|Spearman correlation|spearman correlation|-0.82|||<|0.005|TWO_SIDED|||||R = -0.82|Spearman correlation|||Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|||<.005
91572111|NCT01536197|183033336|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).||||||0.19
91572112|NCT01999777|183033338|SUPERIORITY|||||||0.1972|||||||Wald asymptotic|P-value based on a standard Wald asymptotic test for equality without a continuity correction.||Assumptions included that the proportion of seizures occurring within 6 hours after placebo administration was \~65% and a relative reduction of 50% would result in a reduction of ≥ 32.5 percentage points. Based on a 2-sided 95% confidence interval (CI) for the differences in proportions, a sample size of 62 analyzable subjects was chosen to detect a 0.35 difference between group. Sample size estimations were based on nQuery Version 7.0 using the table for CIs for differences in 2 proportions.||||0.1972
91572113|NCT01999777|183033339|SUPERIORITY|||||||0.1388|||||||Log Rank|||||||0.1388
91572114|NCT03735121|183033363|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.88|1.24||||||||1.24|0.88|
91572115|NCT03735121|183033364|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.83|0.92||||||||0.92|0.83|
91572116|NCT03735121|183033374|SUPERIORITY||Difference in ORR|0.54||||0.8757|TWO_SIDED|95.0|-6.56|7.63|||Cochran-Mantel-Haenszel|||||7.63|-6.56|0.8757
91572117|NCT03735121|183033375|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6906|TWO_SIDED|95.0|0.83|1.33|||Log Rank|||||1.33|0.83|0.6906
91572118|NCT03735121|183033376|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9766|TWO_SIDED|95.0|0.78|1.27|||Log Rank|||||1.27|0.78|0.9766
91572119|NCT03735121|183033377|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.8375|TWO_SIDED|95.0|0.34|2.42|||Log Rank|||||2.42|0.34|0.8375
91572120|NCT02176863|183033391|SUPERIORITY|||||||0.0469||||||The overall adjusted p-value for the selected dose of Flebogamma® 5% DIF vs placebo was calculated from the p-values of both Stage 1 and Stage 2 by Posch \& Bauer for testing the equality of means between the selected dose and placebo.|Posch and Bauer Method|||||||0.0469
91572121|NCT02176863|183033392|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|3.65||0.8897|TWO_SIDED|95.0|-7.7|6.7||MMRM include change from baseline in VAS as dependent variable;treatment,protocol-specified visit,treatment-by-visit interaction,main part affected(fixed effect);baseline as covariate \& measures within-participants at each visit(repeated measure).|Mixed-effect Model Repeated Measures|||||6.7|-7.7|0.8897
91572122|NCT02176863|183033393|SUPERIORITY||LS Mean Difference|1.98|STANDARD_ERROR_OF_MEAN|1.41||0.1615|TWO_SIDED|95.0|-0.8|4.8||MMRM include change from baseline in SF-36PCS as dependent variable;treatment protocol-specified visit,treatment-by-visit interaction,main part affected(fixed effect);baseline measure as covariate \& within-participant at each visit(repeated measure).|Mixed-effect Model Repeated Measures|||||4.8|-0.8|0.1615
91572123|NCT02176863|183033394|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|10.112||0.1205|TWO_SIDED|95.0|-4.19|35.79||MMRM include change from baseline in 6MWD as dependent variable;treatment,protocol-specified visit,treatment-by-visit interaction,main part affected(fixed effect);baseline as covariate \& measures within-participants at each visit(repeated measure).|Mixed-effect Model Repeated Measures|||||35.79|-4.19|0.1205
91572124|NCT02037256|183033396|OTHER||percentage|0.24|||||TWO_SIDED|95.0|0.07|0.5||||||Median time to engraftment||0.50|0.07|
91572125|NCT01527162|183033397|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
91572126|NCT01527162|183033398|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.14
91572127|NCT01527162|183033399|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon Sign Rank TEst||||>.54
91572128|NCT01527162|183033399|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.20
91572129|NCT01310699|183033401|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
91572130|NCT01310699|183033402|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
91572131|NCT03670277|183033495|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|-0.013|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.081|0.056|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.056|-0.081|
91572132|NCT03670277|183033496|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|0.031|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.037|0.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.100|-0.037|
91572133|NCT03670277|183033497|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.403|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|2.557|4.248|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At -30°||4.248|2.557|
91572134|NCT03670277|183033497|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|2.431|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|1.585|3.277|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At +30°||3.277|1.585|
91572135|NCT03670277|183033498|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.039|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|1.854|4.225|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At -30°||4.225|1.854|
91572136|NCT03670277|183033498|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|1.414|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|0.228|2.599|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At +30°||2.599|0.228|
91572137|NCT02660112|183033499|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
91572138|NCT02358668|183033517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.57|TWO_SIDED|95.0|-6.28|11.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.20|-6.28|0.57
91572139|NCT02358668|183033517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.57||||0.72|TWO_SIDED|95.0|-10.3|7.11||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||7.11|-10.3|0.72
91572140|NCT02358668|183033518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.66|TWO_SIDED|95.0|-0.91|1.42||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.42|-0.91|0.66
91572141|NCT02358668|183033518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9|TWO_SIDED|95.0|-1.03|1.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.18|-1.03|0.90
91572142|NCT02358668|183033519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.86|TWO_SIDED|95.0|-0.5|0.59||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.59|-0.50|0.86
91572143|NCT02358668|183033519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.59|TWO_SIDED|95.0|-0.66|0.38||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.38|-0.66|0.59
91572144|NCT02358668|183033520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.62|TWO_SIDED|95.0|-0.44|0.73||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.73|-0.44|0.62
91572145|NCT02358668|183033520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.97|TWO_SIDED|95.0|-0.52|0.55||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.55|-0.52|0.97
91572146|NCT02358668|183033521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.4|TWO_SIDED|95.0|-0.2|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-0.20|0.40
91572147|NCT02358668|183033521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.49|TWO_SIDED|95.0|-0.21|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.21|0.49
91572148|NCT02358668|183033522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.41|TWO_SIDED|95.0|-2.88|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-2.88|0.41
91572149|NCT02358668|183033522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.34||||0.15|TWO_SIDED|95.0|-3.18|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-3.18|0.15
91572150|NCT02358668|183033523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.64|TWO_SIDED|95.0|-0.29|0.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.18|-0.29|0.64
91572151|NCT02358668|183033523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.12|-0.30|0.41
91572152|NCT02358668|183033524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.19||||0.46|TWO_SIDED|95.0|-4.43|2.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.05|-4.43|0.46
91572153|NCT02358668|183033524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75||||0.24|TWO_SIDED|95.0|-4.72|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-4.72|0.24
91572154|NCT02358668|183033525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.13|0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.10|-0.13|0.83
91572155|NCT02358668|183033525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.48|TWO_SIDED|95.0|-0.16|0.08||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.08|-0.16|0.48
91572156|NCT02358668|183033526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.14||||0.83|TWO_SIDED|95.0|-9.17|11.45||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.45|-9.17|0.83
91572157|NCT02358668|183033526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.86|TWO_SIDED|95.0|-11.1|9.27||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||9.27|-11.1|0.86
91572158|NCT02358668|183033527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.75|TWO_SIDED|95.0|-99.6|72.3||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||72.3|-99.6|0.75
91572159|NCT02358668|183033527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.0||||0.34|TWO_SIDED|95.0|-43.9|123.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||123.9|-43.9|0.34
91572160|NCT02358668|183033528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-980.0||||0.23|TWO_SIDED|95.0|-2604.0|643.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||643.8|-2604|0.23
91572161|NCT02358668|183033528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|323.9||||0.68|TWO_SIDED|95.0|-1269.0|1916.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1916.6|-1269|0.68
91572162|NCT02358668|183033529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.79|TWO_SIDED|95.0|-99.6|129.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||129.6|-99.6|0.79
91572163|NCT02358668|183033529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.1||||0.29|TWO_SIDED|95.0|-52.5|172.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||172.6|-52.5|0.29
91572164|NCT02358668|183033530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-120.2||||0.37|TWO_SIDED|95.0|-385.3|144.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||144.9|-385.3|0.37
91572165|NCT02358668|183033530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.69|TWO_SIDED|95.0|-198.1|296.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||296.2|-198.1|0.69
91572166|NCT02358668|183033532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.57|TWO_SIDED|95.0|-9.8|5.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||5.5|-9.8|0.57
91572167|NCT02358668|183033532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.79|TWO_SIDED|95.0|-6.6|8.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||8.6|-6.6|0.79
91572168|NCT02358668|183033533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.54|TWO_SIDED|95.0|-3.4|1.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.8|-3.4|0.54
91572169|NCT02358668|183033533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.68|TWO_SIDED|95.0|-2.0|3.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.1|-2.0|0.68
91572170|NCT02358668|183033534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.03|TWO_SIDED|95.0|-3.2|-0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||-0.1|-3.2|0.03
91572171|NCT02358668|183033534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.86|TWO_SIDED|95.0|-1.7|1.4||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.4|-1.7|0.86
91572172|NCT02358668|183033535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9|TWO_SIDED|95.0|-0.39|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.39|0.90
91572173|NCT02358668|183033535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.3|TWO_SIDED|95.0|-0.63|0.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.20|-0.63|0.30
91572174|NCT02358668|183033536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.52|TWO_SIDED|95.0|-1.32|2.57||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.57|-1.32|0.52
91572175|NCT02358668|183033536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.24|TWO_SIDED|95.0|-0.75|3.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.05|-0.75|0.24
91572176|NCT02358668|183033537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.93|TWO_SIDED|95.0|-0.035|0.038||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.038|-0.035|0.93
91572177|NCT02358668|183033537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.4|TWO_SIDED|95.0|-0.021|0.051||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.051|-0.021|0.40
91572178|NCT02358668|183033538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.36|TWO_SIDED|95.0|-1.2|0.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.5|-1.2|0.36
91572179|NCT02358668|183033538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.36|TWO_SIDED|95.0|-0.4|1.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.2|-0.4|0.36
91572180|NCT02358668|183033539|SUPERIORITY_OR_OTHER|||||||0.09||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.09
91572181|NCT02358668|183033539|SUPERIORITY_OR_OTHER|||||||0.82||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.82
91572182|NCT02358668|183033540|SUPERIORITY_OR_OTHER|||||||0.68||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.68
91572183|NCT02358668|183033540|SUPERIORITY_OR_OTHER|||||||0.26||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.26
91572184|NCT02358668|183033541|SUPERIORITY_OR_OTHER|||||||0.67||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.67
91572185|NCT02358668|183033541|SUPERIORITY_OR_OTHER|||||||0.3||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.30
91572186|NCT02358668|183033542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.01|TWO_SIDED|95.0|-0.48|-0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.11|-0.48|<0.01
91572187|NCT02358668|183033542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.13|TWO_SIDED|95.0|-0.32|0.04||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.04|-0.32|0.13
91572188|NCT02358668|183033543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.01|TWO_SIDED|95.0|-1.01|-0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.18|-1.01|0.01
91572189|NCT02358668|183033543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.42|TWO_SIDED|95.0|-0.57|0.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.24|-0.57|0.42
91572190|NCT02358668|183033544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.02|TWO_SIDED|95.0|-1.35|-0.14||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.14|-1.35|0.02
91572191|NCT02358668|183033544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.57|TWO_SIDED|95.0|-0.75|0.42||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.42|-0.75|0.57
91572192|NCT02358668|183033545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|||<|0.01|TWO_SIDED|95.0|-0.52|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.52|<0.01
91572193|NCT02358668|183033545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.14|TWO_SIDED|95.0|-0.34|0.05||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.05|-0.34|0.14
91572194|NCT02358668|183033546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|||<|0.01|TWO_SIDED|95.0|-0.52|-0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.10|-0.52|<0.01
91572195|NCT02358668|183033546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.38|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.12|-0.30|0.38
91572196|NCT02358668|183033547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.01|TWO_SIDED|95.0|-0.48|-0.07||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.07|-0.48|0.01
91572197|NCT02358668|183033547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.41|TWO_SIDED|95.0|-0.28|0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.11|-0.28|0.41
91572198|NCT02358668|183033548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.40|0.08
91572199|NCT02358668|183033548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.1|TWO_SIDED|95.0|-0.38|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.38|0.10
91572200|NCT02358668|183033549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.01|TWO_SIDED|95.0|-0.67|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.67|0.01
91572201|NCT02358668|183033549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.54|TWO_SIDED|95.0|-0.35|0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.18|-0.35|0.54
91572202|NCT02358668|183033550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.03|TWO_SIDED|95.0|-0.81|-0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.03|-0.81|0.03
91572203|NCT02358668|183033550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.63|TWO_SIDED|95.0|-0.48|0.29||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.29|-0.48|0.63
91572204|NCT02358668|183033551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.18|TWO_SIDED|95.0|-0.13|0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.02|-0.13|0.18
91572205|NCT02358668|183033551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.73|TWO_SIDED|95.0|-0.06|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-0.06|0.73
91572206|NCT02358668|183033552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
91572207|NCT02358668|183033552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
91572208|NCT02358668|183033553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
91572209|NCT02358668|183033553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
91572210|NCT02358668|183033554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.03|TWO_SIDED|95.0|-0.31|-0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.02|-0.31|0.03
91572211|NCT02358668|183033554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.87|TWO_SIDED|95.0|-0.13|0.15||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.15|-0.13|0.87
91572212|NCT02358668|183033555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.34|TWO_SIDED|95.0|-1.46|0.5||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.50|-1.46|0.34
91572213|NCT02358668|183033555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.64|TWO_SIDED|95.0|-0.73|1.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.18|-0.73|0.64
91572214|NCT02358668|183033556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.17|TWO_SIDED|95.0|-1.5|0.26||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.26|-1.50|0.17
91572215|NCT02358668|183033556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.37|TWO_SIDED|95.0|-0.46|1.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.24|-0.46|0.37
91572216|NCT02358668|183033557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.18|TWO_SIDED|95.0|-1.62|0.31||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.31|-1.62|0.18
91572217|NCT02358668|183033557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.37|TWO_SIDED|95.0|-0.51|1.36||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.36|-0.51|0.37
91572218|NCT02358668|183033558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14||||0.06|TWO_SIDED|95.0|-4.36|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-4.36|0.06
91572219|NCT02358668|183033558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.69|TWO_SIDED|95.0|-1.71|2.58||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||2.58|-1.71|0.69
91572220|NCT02358668|183033559|SUPERIORITY_OR_OTHER|||||||0.29||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.29
91572221|NCT02358668|183033559|SUPERIORITY_OR_OTHER|||||||0.22||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.22
91572222|NCT02358668|183033560|SUPERIORITY_OR_OTHER|||||||0.41||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.41
91572223|NCT02358668|183033560|SUPERIORITY_OR_OTHER|||||||0.48||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.48
91572224|NCT02358668|183033561|SUPERIORITY_OR_OTHER|||||||0.61||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.61
91572225|NCT02358668|183033561|SUPERIORITY_OR_OTHER|||||||0.89||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.89
91572226|NCT02104505|183033562|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.04|TWO_SIDED||||||Mixed Models Analysis||Comparison of change in sputum %PMNs during active treatment vs placebo (crossover design).|||||0.04
91572227|NCT02104505|183033563|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
91572228|NCT02104505|183033564|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.6
91572229|NCT02104505|183033565|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.34|TWO_SIDED||||||Mixed Models Analysis|||||||0.34
91572230|NCT01730950|183033567|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.7|1.38|||Log Rank|Two-side significance level = 0.05|Reference level = Bevacizumab|Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.||1.38|0.70|0.46
91572231|NCT01730950|183033568|SUPERIORITY|||||||0.18|||||||Chi-squared|Two-sided significance level = 0.05||||||0.18
91572232|NCT01730950|183033569|SUPERIORITY|||||||0.001|||||||Chi-squared|Two-sided significance level = 0.05||||||0.001
91572233|NCT01730950|183033570|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.53|1.0|||Log Rank|Two-sided significance level = 0.05|Reference level = Bevacizumab|||1.00|0.53|0.05
91572234|NCT05224843|183033608|OTHER||Percentage of enrolled from eligible|82.5|||||TWO_SIDED|95.0|73.7|88.8||||||||88.8|73.7|
91572235|NCT05224843|183033609|OTHER||Percentage of enrolled from eligible|100.0|||||TWO_SIDED|95.0|95.4|100.0||||||||100|95.4|
91572236|NCT05224843|183033611|OTHER||Percentage screened positive for EM|7.5|||||TWO_SIDED|95.0|3.5|15.4||||||||15.4|3.5|
91572237|NCT05224843|183033613|OTHER||Percentage who changed after BNI|25.0|||||TWO_SIDED|95.0|4.6|69.9||||||||69.9|4.6|
91572238|NCT05224843|183033614|OTHER||Percentage reported APS from EM positive|20.0|||||TWO_SIDED|95.0|3.6|62.4||||||||62.4|3.6|
91572239|NCT05274750|183033618|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.3|-1.1|<0.001
91572240|NCT05274750|183033619|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.23||||0.047|TWO_SIDED|95.0|-0.46|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||0.00|-0.46|0.047
91572241|NCT05274750|183033620|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5 percent (%) reference level.|Difference in Least Square Means|-0.22||||0.074|TWO_SIDED|95.0|-0.46|0.02|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.02|-0.46|0.074
91572242|NCT05274750|183033621|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.19||||0.055|TWO_SIDED|95.0|-0.39|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.00|-0.39|0.055
91572243|NCT05274750|183033622|OTHER|Analysis performed using an analysis of covariance model (ANCOVA) with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region and previous surgery for nasal polyps. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-2.0||||0.002|TWO_SIDED|95.0|-3.3|-0.8|||ANCOVA|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.8|-3.3|0.002
91572244|NCT05274750|183033623|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-6.8||||0.113|TWO_SIDED|95.0|-15.2|1.6|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||1.6|-15.2|0.113
91572245|NCT05274750|183033624|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.17||||0.094|TWO_SIDED|95.0|-0.37|0.03|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 21 to Week 24 in participants with a diagnosis of CRSwNP||0.03|-0.37|0.094
91572246|NCT05274750|183033625|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 26 in participants with a diagnosis of CRSwNP||-0.4|-1.1|<0.001
91572247|NCT05274750|183033626|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.735||||0.128|TWO_SIDED|95.0|0.495|1.092|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.092|0.495|0.128
91572248|NCT05274750|183033627|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.713||||0.146|TWO_SIDED|95.0|0.453|1.124|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.124|0.453|0.146
91572249|NCT05274750|183033628|OTHER|Logistic regression with covariates of treatment, number of courses of systemic CS in 12 months prior to screening for NP (0, 1, \>1), log(e) baseline blood eosinophil count, baseline total endoscopic NP score, baseline nasal obstruction score (VRS), region, study and previous surgery for NPs. The study covariate is removed for individual study analyses. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Odds Ratio (OR)|0.58||||0.006|TWO_SIDED|95.0|0.4|0.86|||Regression, Logistic|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||0.86|0.40|0.006
91572250|NCT05274750|183033629|OTHER|The pooled statistical analyses will be performed using a Mixed Models Repeated Measures (MMRM) model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, study, visit and interaction terms for visit by baseline score and visit by treatment group. If the hierarchy is broken, subsequent endpoints will be evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|-0.75||||0.004|TWO_SIDED|95.0|-1.26|-0.25|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||-0.25|-1.26|0.004
91572251|NCT04328623|183033634|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91572252|NCT02312557|183033643|OTHER||Proportion|0.19|||<|0.01|TWO_SIDED|95.0|0.09|0.29|||One-sample binomial test of proportion|||||0.29|0.09|<0.01
91572253|NCT02330094|183033661|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
91572254|NCT02330094|183033662|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
91572255|NCT02330094|183033663|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
91572256|NCT03721172|183033668|SUPERIORITY||Adjusted difference|17.5|||<|0.0001|TWO_SIDED|95.0|12.2|22.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||22.8|12.2|<0.0001
91572257|NCT03721172|183033669|SUPERIORITY||Adjusted difference|25.6|||<|0.0001|TWO_SIDED|95.0|19.1|32.1|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.1|19.1|<0.0001
91572258|NCT03721172|183033670|SUPERIORITY||Least squares mean difference|-3.38|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-4.04|-2.73|||Mixed-effect model for repeated measures|||||-2.73|-4.04|<0.0001
91572259|NCT03721172|183033671|SUPERIORITY||Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.47|-2.39|||Mixed-effect model for repeated measures|||||-2.39|-3.47|<0.0001
91572260|NCT03721172|183033672|SUPERIORITY||Adjusted difference|38.0|||<|0.0001|TWO_SIDED|95.0|29.7|46.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||46.3|29.7|<0.0001
91572261|NCT03721172|183033673|SUPERIORITY||Adjusted difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.5|32.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.8|16.5|<0.0001
91572262|NCT03721172|183033674|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|18.6|36.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||36.3|18.6|<0.0001
91572263|NCT03721172|183033675|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.7|-2.1|||Mixed-effect model for repeated measures|||||-2.1|-3.7|<0.0001
91572264|NCT00607672|183033702|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Mixed Models Analysis|||||||0.28
91572265|NCT00607672|183033703|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Mixed Models Analysis|||||||0.84
91572266|NCT00607672|183033704|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Kruskal-Wallis|||||||0.67
91572267|NCT00607672|183033705|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
91572268|NCT00607672|183033706|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||For plasma transfusion comparison. Ramipril and Candesartan versus placebo|Chi-squared|||||||0.04
91572269|NCT00607672|183033707|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||Comparison for norepinephrine use|Chi-squared|||||||0.27
91572270|NCT00607672|183033708|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
91572271|NCT00607672|183033709|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|||||||0.51
91572272|NCT00607672|183033710|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Chi-squared|||||||0.87
91572273|NCT00607672|183033711|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|||||||0.04
91572274|NCT00607672|183033712|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Mixed Models Analysis|||||||0.69
91572275|NCT00607672|183033713|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||||||0.97
91572276|NCT00607672|183033714|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Mixed Models Analysis|||||||0.46
91572277|NCT00825305|183033760|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean|-0.2|||||TWO_SIDED|95.0|-0.81|0.4|||ANOVA||Ratio of log2 mean (Zagreb/Essen) on day 14|||0.4|-0.81|
91572278|NCT00825305|183033761|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day7)|-0.21|||||TWO_SIDED|95.0|-0.77|0.35|||ANOVA||Ratio of log2 means (Zagreb/Essen) on day 7|||0.35|-0.77|
91572279|NCT00825305|183033761|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day 42)|-0.07|||||TWO_SIDED|95.0|-0.72|0.58|||ANOVA||Ratio of log2 mean (Zagreb/(Essen) on day 42|||0.58|-0.72|
91572280|NCT03617289|183033769|SUPERIORITY|||||||0.771||||||Threshold for statistical significance set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.771
91572281|NCT03617289|183033770|SUPERIORITY||||||<|0.046||||||Threshold for statistical significance was set at p\<0.05|Chi-squared|||||||<0.046
91572282|NCT03332784|183033814|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
91572283|NCT03332784|183033814|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
91572284|NCT03332784|183033814|SUPERIORITY|||||||0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||0.0001
91572285|NCT00763451|183033836|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.583|-0.232||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.232|-0.583|<0.0001
91572286|NCT00763451|183033836|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.317||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.317|-0.670|<0.0001
91572287|NCT01827046|183033844|SUPERIORITY||Risk Difference (RD)|2.0||||0.73|TWO_SIDED|95.0|-6.8|10.7|||Chi-squared|||||10.7|-6.8|0.73
91572288|NCT01827046|183033844|SUPERIORITY||Risk Difference (RD)|4.0||||0.33|TWO_SIDED|95.0|-4.0|12.0|||Multivariate logit model|||Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location||12|-4|0.33
91572289|NCT01827046|183033845|SUPERIORITY||Risk Difference (RD)|0.03||||0.55|TWO_SIDED|95.0|-0.06|0.11|||Chi-squared|||||0.11|-0.06|0.55
91572290|NCT01827046|183033845|SUPERIORITY||Risk Difference (RD)|1.26||||0.27|TWO_SIDED|95.0|0.82|1.97|||Multivariate logit model|Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location||||1.97|0.82|0.27
91572291|NCT01827046|183033846|SUPERIORITY|||||||0.08|TWO_SIDED|95.0|||||Log Rank|||||||0.08
91572292|NCT01827046|183033846|SUPERIORITY||Cox Proportional Hazard|0.67||||0.037|TWO_SIDED|95.0|0.45|0.98|||Adjusted Cox proportional Hazard|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.||||0.98|0.45|0.037
91572293|NCT01827046|183033847|SUPERIORITY||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.62|0.8|||Logit model|||||0.80|0.62|<0.001
91572294|NCT01827046|183033847|SUPERIORITY||Odds Ratio (OR)|0.68|||<|0.001|TWO_SIDED|95.0|0.59|0.78|||Multivariate logit model|Adjusted for age, GCS, stability IVH volume, and ICH deep location||||0.78|0.59|<0.001
91572295|NCT01827046|183033848|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91572296|NCT01827046|183033849|SUPERIORITY||Risk Difference (RD)|0.04||||0.34|TWO_SIDED|95.0|-0.04|0.11|||Chi-squared|||||0.11|-0.04|0.34
91572297|NCT01827046|183033850|SUPERIORITY||Risk Difference (RD)|-0.01||||0.76|TWO_SIDED|95.0|-0.1|0.07|||Chi-squared|||||0.07|-0.10|0.76
91572298|NCT01827046|183033850|SUPERIORITY||Odds Ratio (OR)|1.25||||0.31|TWO_SIDED|95.0|0.81|1.94|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.94|0.81|0.31
91572299|NCT01827046|183033851|SUPERIORITY||Risk Difference (RD)|0.01||||0.79|TWO_SIDED|95.0|-0.07|0.09|||Chi-squared|||||0.09|-0.07|0.79
91572300|NCT01827046|183033851|SUPERIORITY||Odds Ratio (OR)|1.24||||0.35|TWO_SIDED|95.0|0.79|1.97|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.97|0.79|0.35
91572301|NCT01827046|183033852|SUPERIORITY|||||||0.46|||||||Median test|||||||0.46
91572302|NCT01827046|183033853|SUPERIORITY|||||||0.75|||||||Median test|||||||0.75
91572303|NCT01827046|183033854|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
91572304|NCT01827046|183033855|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
91572305|NCT01827046|183033856|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
91572306|NCT01827046|183033857|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91572307|NCT01827046|183033858|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
91572308|NCT01827046|183033859|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
91572309|NCT01827046|183033860|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91572310|NCT02357264|183033866|OTHER|||||||0.162|||||||Fisher Exact|||||||.162
91572311|NCT05594589|183033867|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.377||||0.0133|TWO_SIDED|95.0|0.175|0.81|||ANCOVA|P-value was based on analysis of covariance (ANCOVA) model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 5 mg/Placebo.|||0.810|0.175|0.0133
91572312|NCT05594589|183033868|SUPERIORITY||LSGM Ratio|0.48||||0.0619|TWO_SIDED|95.0|0.222|1.038|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 10 mg/Placebo.|||1.038|0.222|0.0619
91572313|NCT05594589|183033869|SUPERIORITY||Least Square Mean (LSM) Difference|7.38||||0.0689|TWO_SIDED|95.0|-0.59|15.35|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 5 mg - Placebo.|||15.35|-0.59|0.0689
91572314|NCT05594589|183033870|SUPERIORITY||LSM Difference|8.16||||0.0439|TWO_SIDED|95.0|0.23|16.09|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 10 mg - Placebo.|||16.09|0.23|0.0439
91572315|NCT00715117|183033906|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
91572316|NCT00715117|183033906|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
91572317|NCT00715117|183033907|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Bowel symptoms||||>0.05
91572318|NCT00715117|183033907|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Social well-being||||0.035
91572319|NCT00715117|183033907|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Emotional well-being||||>0.05
91572320|NCT00715117|183033907|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|95.0||||Systemic symptoms|t-test, 2 sided|||||||0.035
91572321|NCT00715117|183033907|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Body Image||||>0.05
91572322|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sleep disturbance||||1.0
91572323|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||Unusual dreams||||0.45
91572324|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Twitching||||1.0
91572325|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Headaches||||1.0
91572326|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Decreased appetite||||1.0
91572327|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Nausea||||1.0
91572328|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Hair loss||||1.0
91572329|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Fatigue||||1.0
91572330|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Flushed ears||||1.0
91572331|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Papules, rash||||1.0
91572332|NCT00715117|183033908|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Double vision||||1.0
91572333|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|2.39|||||TWO_SIDED|95.0|1.39|4.1|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||4.1|1.39|
91572334|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.71|||||TWO_SIDED|95.0|0.42|1.2|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||1.2|0.42|
91572335|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|1.68|||||TWO_SIDED|95.0|0.98|2.9|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||2.9|0.98|
91572336|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|1.31|||||TWO_SIDED|95.0|0.59|2.91|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||2.91|0.59|
91572337|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|11.0|52.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||52|11|
91572338|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|31.0|||||TWO_SIDED|95.0|14.0|69.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||69|14|
91572339|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|1.3|||||TWO_SIDED|95.0|0.7|2.42|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||2.42|0.7|
91572340|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|5.56|||||TWO_SIDED|95.0|3.01|10.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||10|3.01|
91572341|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|7.22|||||TWO_SIDED|95.0|3.86|13.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||13|3.86|
91572342|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|2.64|||||TWO_SIDED|95.0|1.4|4.99|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||4.99|1.4|
91572343|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|1.05|||||TWO_SIDED|95.0|0.56|1.97|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||1.97|0.56|
91572344|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|2.78|||||TWO_SIDED|95.0|1.47|5.27|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||5.27|1.47|
91572345|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.52|||||TWO_SIDED|95.0|0.23|1.13|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||1.13|0.23|
91572346|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|45.0|||||TWO_SIDED|95.0|21.0|97.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||97|21|
91572347|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|23.0|||||TWO_SIDED|95.0|10.0|51.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||51|10|
91572348|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.4|||||TWO_SIDED|95.0|0.2|0.82|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||0.82|0.2|
91572349|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|12.0|48.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||48|12|
91572350|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|9.61|||||TWO_SIDED|95.0|4.69|20.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||20|4.69|
91572351|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|1.11|||||TWO_SIDED|95.0|0.55|2.21|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||2.21|0.55|
91572352|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|2.51|||||TWO_SIDED|95.0|1.27|4.96|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||4.96|1.27|
91572353|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|2.77|||||TWO_SIDED|95.0|1.38|5.57|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||5.57|1.38|
91572354|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.54|||||TWO_SIDED|95.0|0.28|1.04|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.28|
91572355|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|50.0|||||TWO_SIDED|95.0|26.0|94.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||94|26|
91572356|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|27.0|||||TWO_SIDED|95.0|14.0|52.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||52|14|
91572357|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.6|||||TWO_SIDED|95.0|0.34|1.04|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.34|
91572358|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|35.0|||||TWO_SIDED|95.0|20.0|60.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||60|20|
91572359|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|21.0|||||TWO_SIDED|95.0|12.0|36.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||36|12|
91572360|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.9|||||TWO_SIDED|95.0|0.48|1.69|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||1.69|0.48|
91572361|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|3.61|||||TWO_SIDED|95.0|1.94|6.74||||||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.74|1.94|
91572362|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|3.24|||||TWO_SIDED|95.0|1.71|6.13|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.13|1.71|
91572363|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.33|||||TWO_SIDED|95.0|0.16|0.66|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||0.66|0.16|
91572364|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|121.0|||||TWO_SIDED|95.0|61.0|241.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||241|61|
91572365|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|40.0|||||TWO_SIDED|95.0|20.0|80.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||80|20|
91572366|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|0.58|||||TWO_SIDED|95.0|0.32|1.05|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||1.05|0.32|
91572367|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|33.0|||||TWO_SIDED|95.0|18.0|60.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||60|18|
91572368|NCT01018732|183033923|SUPERIORITY_OR_OTHER||ratio of titer|19.0|||||TWO_SIDED|95.0|10.0|35.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||35|10|
91572369|NCT01262092|183033933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2887||||0.035||95.0||||p values \<0.05 considered statistically significant|Mixed Models Analysis|Used proc GLIMMIX to model group by time (6 study visits)||"test null hypothesis that gbp and pla did not differ in terms of opioid-positive urines during the buprenorphine detox.~For the analysis, data from 2 participants in the GBP groups were excluded due to evidence of medication diversion (N=1) and not being maintained on the 1600 mg/day dose of GBP (N=1)."||||0.035
91572370|NCT03784820|183033934|SUPERIORITY||Odds Ratio (OR)|0.35||||0.36|TWO_SIDED|95.0|0.04|3.27||Comparison of Patients at Post (T2) \[CBT-E is the reference\]|Mixed Models Analysis|||||3.27|0.04|0.36
91572371|NCT03784820|183033934|SUPERIORITY||Odds Ratio (OR)|0.29||||0.38|TWO_SIDED|95.0|0.02|4.6||Comparison of Patients at 3 Month Fup (T3) \[CBT-E is the reference\]|Mixed Models Analysis|||||4.60|0.02|0.38
91572372|NCT03784820|183033934|SUPERIORITY||Odds Ratio (OR)|2.2||||0.54|TWO_SIDED|95.0|0.18|27.39||Comparison of Patients at 6 Month Fup (T4) \[CBT-E is the reference\]|Mixed Models Analysis|||||27.39|0.18|0.54
91572373|NCT03784820|183033935|SUPERIORITY||LS mean difference|0.51||||0.52|TWO_SIDED|95.0|-1.06|2.09||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.09|-1.06|0.52
91572374|NCT03784820|183033935|SUPERIORITY||LS mean difference|0.04||||0.97|TWO_SIDED|95.0|-1.99|2.07||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.07|-1.99|0.97
91572375|NCT03784820|183033935|SUPERIORITY||LS mean difference|0.62||||0.59|TWO_SIDED|95.0|-1.66|2.89||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.89|-1.66|0.59
91572376|NCT03784820|183033936|SUPERIORITY||LS mean difference|0.05||||0.86|TWO_SIDED|95.0|-0.45|0.54||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.54|-0.45|0.86
91572377|NCT03784820|183033936|SUPERIORITY||LS mean difference|0.3||||0.44|TWO_SIDED|95.0|-0.46|1.06||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||1.06|-0.46|0.44
91572378|NCT03784820|183033936|SUPERIORITY||LS mean difference|0.31||||0.36|TWO_SIDED|95.0|-0.36|0.98||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.98|-0.36|0.36
91572379|NCT03784820|183033937|SUPERIORITY||LS mean difference|2.47||||0.33|TWO_SIDED|95.0|-2.54|7.49||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||7.49|-2.54|0.33
91572380|NCT03784820|183033937|SUPERIORITY||LS mean difference|2.18||||0.46|TWO_SIDED|95.0|-3.59|7.95||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-3.59|0.46
91572381|NCT03784820|183033937|SUPERIORITY||LS mean difference|3.83||||0.27|TWO_SIDED|95.0|-2.94|10.6||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||10.60|-2.94|0.27
91572382|NCT03784820|183033938|SUPERIORITY||LS mean difference|1.06||||0.62|TWO_SIDED|95.0|-3.14|5.25||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||5.25|-3.14|0.62
91572383|NCT03784820|183033938|SUPERIORITY||LS mean difference|1.83||||0.54|TWO_SIDED|95.0|-4.07|7.73||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||7.73|-4.07|0.54
91572384|NCT03784820|183033939|SUPERIORITY||LS mean difference|4.8||||0.1|TWO_SIDED|95.0|-0.91|10.51||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||10.51|-0.91|0.10
91572385|NCT03784820|183033939|SUPERIORITY||LS mean difference|1.08||||0.76|TWO_SIDED|95.0|-5.97|8.13||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.13|-5.97|0.76
91572386|NCT03784820|183033939|SUPERIORITY||LS mean difference|3.26||||0.23|TWO_SIDED|95.0|-2.03|8.55||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||8.55|-2.03|0.23
91572387|NCT03784820|183033939|SUPERIORITY||LS mean difference|-0.25||||0.94|TWO_SIDED|95.0|-6.63|6.14||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||6.14|-6.63|0.94
91572388|NCT03784820|183033939|SUPERIORITY||LS mean difference|-1.46||||0.68|TWO_SIDED|95.0|-8.38|5.46||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||5.46|-8.38|0.68
91572389|NCT03784820|183033939|SUPERIORITY||LS mean difference|-0.61||||0.89|TWO_SIDED|95.0|-9.06|7.84||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||7.84|-9.06|0.89
91572390|NCT03784820|183033940|SUPERIORITY||LS mean difference|-0.41||||0.91|TWO_SIDED|95.0|-7.61|6.79||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.79|-7.61|0.91
91572391|NCT03784820|183033940|SUPERIORITY||LS mean difference|4.72||||0.2|TWO_SIDED|95.0|-2.49|11.93||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||11.93|-2.49|0.20
91572392|NCT03784820|183033940|SUPERIORITY||LS mean difference|4.78||||0.14|TWO_SIDED|95.0|-1.63|11.2||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||11.20|-1.63|0.14
91572393|NCT03784820|183033940|SUPERIORITY||LS mean difference|3.86||||0.25|TWO_SIDED|95.0|-2.76|10.49||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||10.49|-2.76|0.25
91572394|NCT03784820|183033940|SUPERIORITY||LS mean difference|4.22||||0.14|TWO_SIDED|95.0|-1.45|9.89||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||9.89|-1.45|0.14
91572395|NCT03784820|183033940|SUPERIORITY||LS mean difference|3.15||||0.28|TWO_SIDED|95.0|-2.58|8.87||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||8.87|-2.58|0.28
91572396|NCT03784820|183033941|SUPERIORITY||LS mean difference|1.73||||0.85|TWO_SIDED|95.0|-16.73|20.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||20.19|-16.73|0.85
91572397|NCT03784820|183033941|SUPERIORITY||LS mean difference|7.94||||0.47|TWO_SIDED|95.0|-13.59|29.48||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||29.48|-13.59|0.47
91572398|NCT03784820|183033941|SUPERIORITY||LS mean difference|9.79||||0.37|TWO_SIDED|95.0|-11.5|31.08||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||31.08|-11.50|0.37
91572399|NCT03784820|183033941|SUPERIORITY||LS mean difference|0.36||||0.97|TWO_SIDED|95.0|-19.31|20.03||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||20.03|-19.31|0.97
91572400|NCT03784820|183033941|SUPERIORITY||LS mean difference|-5.88||||0.52|TWO_SIDED|95.0|-23.85|12.09||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||12.09|-23.85|0.52
91572401|NCT03784820|183033941|SUPERIORITY||LS mean difference|-3.55||||0.68|TWO_SIDED|95.0|-20.33|13.23||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||13.23|-20.33|0.68
91572402|NCT03784820|183033942|SUPERIORITY||LS mean difference|-0.27||||0.91|TWO_SIDED|95.0|-5.02|4.47||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.47|-5.02|0.91
91572403|NCT03784820|183033942|SUPERIORITY||LS mean difference|4.73||||0.07|TWO_SIDED|95.0|-0.36|9.81||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||9.81|-0.36|0.07
91572404|NCT03784820|183033942|SUPERIORITY||LS mean difference|1.75||||0.65|TWO_SIDED|95.0|-5.73|9.23||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.23|-5.73|0.65
91572405|NCT03784820|183033942|SUPERIORITY||LS mean difference|-2.05||||0.52|TWO_SIDED|95.0|-8.21|4.12|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||4.12|-8.21|0.52
91572406|NCT03784820|183033942|SUPERIORITY||LS mean difference|-6.62||||0.07|TWO_SIDED|95.0|-13.74|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-13.74|0.07
91572407|NCT03784820|183033942|SUPERIORITY||LS mean difference|-6.64||||0.03|TWO_SIDED|95.0|-12.73|-0.56||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.56|-12.73|0.03
91572408|NCT03784820|183033943|SUPERIORITY||LS mean difference|0.88||||0.9|TWO_SIDED|95.0|-13.43|15.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||15.19|-13.43|0.90
91572409|NCT03784820|183033943|SUPERIORITY||LS mean difference|-0.64||||0.95|TWO_SIDED|95.0|-18.95|17.66||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||17.66|-18.95|0.95
91572410|NCT03784820|183033943|SUPERIORITY||LS mean difference|1.37||||0.89|TWO_SIDED|95.0|-17.17|19.9||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||19.90|-17.17|0.89
91572411|NCT03784820|183033943|SUPERIORITY||LS mean difference|5.81||||0.39|TWO_SIDED|95.0|-7.37|18.98|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||18.98|-7.37|0.39
91572412|NCT03784820|183033943|SUPERIORITY||LS mean difference|6.29||||0.36|TWO_SIDED|95.0|-7.26|19.84||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||19.84|-7.26|0.36
91572413|NCT03784820|183033943|SUPERIORITY||LS mean difference|-1.55||||0.87|TWO_SIDED|95.0|-20.0|16.91||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||16.91|-20.00|0.87
91572414|NCT03784820|183033944|SUPERIORITY||LS mean difference|0.27||||0.84|TWO_SIDED|95.0|-2.29|2.83||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.83|-2.29|0.84
91572415|NCT03784820|183033944|SUPERIORITY||LS mean difference|-0.82||||0.57|TWO_SIDED|95.0|-3.66|2.01||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.01|-3.66|0.57
91572416|NCT03784820|183033944|SUPERIORITY||LS mean difference|0.6||||0.67|TWO_SIDED|95.0|-2.15|3.35||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.35|-2.15|0.67
91572417|NCT03784820|183033944|SUPERIORITY||LS mean difference|0.46||||0.63|TWO_SIDED|95.0|-1.43|2.35||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.35|-1.43|0.63
91572418|NCT03784820|183033944|SUPERIORITY||LS mean difference|1.44||||0.21|TWO_SIDED|95.0|-0.82|3.7||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||3.70|-0.82|0.21
91572419|NCT03784820|183033944|SUPERIORITY||LS mean difference|1.07||||0.34|TWO_SIDED|95.0|-1.14|3.28||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||3.28|-1.14|0.34
91572420|NCT03784820|183033945|SUPERIORITY||LS mean difference|-3.42||||0.5|TWO_SIDED|95.0|-13.36|6.52||Demand/Withdraw score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.52|-13.36|0.50
91572421|NCT03784820|183033945|SUPERIORITY||LS mean difference|-0.47||||0.89|TWO_SIDED|95.0|-7.49|6.54||Demand/Withdraw Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||6.54|-7.49|0.89
91572422|NCT03784820|183033945|SUPERIORITY||LS mean difference|-0.63||||0.86|TWO_SIDED|95.0|-7.56|6.3||Demand/Withdraw Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||6.30|-7.56|0.86
91572423|NCT03784820|183033945|SUPERIORITY||LS mean difference|2.55||||0.25|TWO_SIDED|95.0|-1.83|6.93||Constructive Communication Score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.93|-1.83|0.25
91572424|NCT03784820|183033945|SUPERIORITY||LS mean difference|2.05||||0.56|TWO_SIDED|95.0|-4.83|8.92||Constructive Communication Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.92|-4.83|0.56
91572425|NCT03784820|183033945|SUPERIORITY||LS mean difference|3.13||||0.34|TWO_SIDED|95.0|-3.27|9.54||Constructive Communication Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.54|-3.27|0.34
91572426|NCT03784820|183033945|SUPERIORITY||LS mean difference|-10.24||||0.02|TWO_SIDED|95.0|-19.05|-1.42||Demand/Withdraw score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||-1.42|-19.05|0.02
91572427|NCT03784820|183033945|SUPERIORITY||LS mean difference|-0.12||||0.98|TWO_SIDED|95.0|-8.18|7.95||Demand/Withdraw score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-8.18|0.98
91572428|NCT03784820|183033945|SUPERIORITY||LS mean difference|-2.2||||0.59|TWO_SIDED|95.0|-10.1|5.7||Demand/Withdraw score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||5.70|-10.10|0.59
91572429|NCT03784820|183033945|SUPERIORITY||LS mean difference|2.41||||0.16|TWO_SIDED|95.0|-0.99|5.82||Constructive Communication Score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||5.82|-0.99|0.16
91572430|NCT03784820|183033945|SUPERIORITY||LS mean difference|3.94||||0.12|TWO_SIDED|95.0|-1.05|8.93||Constructive Communication Score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||8.93|-1.05|0.12
91572431|NCT03784820|183033945|SUPERIORITY||LS mean difference|2.26||||0.34|TWO_SIDED|95.0|-2.35|6.87||Constructive Communication Score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||6.87|-2.35|0.34
91572432|NCT03784820|183033946|SUPERIORITY||LS mean difference|0.09||||0.7|TWO_SIDED|95.0|-0.35|0.53||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.53|-0.35|0.70
91572433|NCT03784820|183033946|SUPERIORITY||LS mean difference|-0.03||||0.9|TWO_SIDED|95.0|-0.48|0.42||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||0.42|-0.48|0.90
91572434|NCT03784820|183033946|SUPERIORITY||LS mean difference|0.25||||0.38|TWO_SIDED|95.0|-0.31|0.82||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.82|-0.31|0.38
91572435|NCT03784820|183033947|SUPERIORITY||LS mean difference|-0.33||||0.89|TWO_SIDED|95.0|-5.1|4.43||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.43|-5.10|0.89
91572436|NCT03784820|183033947|SUPERIORITY||LS mean difference|0.45||||0.85|TWO_SIDED|95.0|-4.14|5.04||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||5.04|-4.14|0.85
91572437|NCT03784820|183033947|SUPERIORITY||LS mean difference|-0.85||||0.72|TWO_SIDED|95.0|-5.54|3.85||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.85|-5.54|0.72
91572438|NCT03784820|183033947|SUPERIORITY||LS mean difference|-3.05||||0.29|TWO_SIDED|95.0|-8.73|2.63||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.63|-8.73|0.29
91572439|NCT03784820|183033947|SUPERIORITY||LS mean difference|-4.69||||0.08|TWO_SIDED|95.0|-9.9|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-9.90|0.08
91572440|NCT03784820|183033947|SUPERIORITY||LS mean difference|-3.29||||0.19|TWO_SIDED|95.0|-8.23|1.65||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||1.65|-8.23|0.19
91572441|NCT03784820|183033948|SUPERIORITY||LS mean difference|-1.2||||0.41|TWO_SIDED|95.0|-4.08|1.67||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||1.67|-4.08|0.41
91572442|NCT03784820|183033948|SUPERIORITY||LS mean difference|0.33||||0.84|TWO_SIDED|95.0|-2.87|3.54||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||3.54|-2.87|0.84
91572443|NCT03784820|183033948|SUPERIORITY||LS mean difference|-1.21||||0.5|TWO_SIDED|95.0|-4.76|2.34||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.34|-4.76|0.50
91572444|NCT03784820|183033948|SUPERIORITY||LS mean difference|-1.09||||0.52|TWO_SIDED|95.0|-4.43|2.24||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.24|-4.43|0.52
91572445|NCT03784820|183033948|SUPERIORITY||LS mean difference|-1.38||||0.3|TWO_SIDED|95.0|-3.96|1.21||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||1.21|-3.96|0.30
91572446|NCT03784820|183033948|SUPERIORITY||LS mean difference|-2.52||||0.03|TWO_SIDED|95.0|-4.78|-0.25||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.25|-4.78|0.03
91572447|NCT03784820|183033949|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.79|TWO_SIDED|95.0|-3.66|4.72||Comparison of Patients at Post (T2)|t-test, 2 sided|||||4.72|-3.66|0.79
91572448|NCT00356811|183033962|SUPERIORITY_OR_OTHER||percentage of participants|50.9|||||TWO_SIDED|95.0|37.3|64.4|||||The estimated value represents the percentage of participants with a confirmed CR or PR.|||64.4|37.3|
91572449|NCT02201901|183033990|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
91572450|NCT02201901|183033990|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
91572451|NCT02201901|183033990|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
91572452|NCT01385748|183034047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.165|TWO_SIDED|95.0|0.387|1.186|||Log Rank|The log rank test at 5% significance level was used.||||1.186|0.387|0.165
91572453|NCT01385748|183034047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.421|TWO_SIDED|95.0|0.495|1.35|||Log Rank|The log rank test at 5% significance level was used.||||1.35|0.495|0.421
91572454|NCT01385748|183034047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.211|TWO_SIDED|95.0|0.484|1.175|||Log Rank|The log rank test at 5% significance level was used.||||1.175|0.484|0.211
91572455|NCT01385748|183034050|SUPERIORITY_OR_OTHER|||||||0.807||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.807
91572456|NCT01385748|183034050|SUPERIORITY_OR_OTHER|||||||0.971||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.971
91572457|NCT01385748|183034052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.698||||0.199|TWO_SIDED|95.0|0.398|1.223||Significance threshold = 5%|Log Rank|||||1.223|0.398|0.199
91572458|NCT01385748|183034052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.424|TWO_SIDED|95.0|0.493|1.353|||Log Rank|Significance threshold = 5%||||1.353|0.493|0.424
91572459|NCT01385748|183034052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.235|TWO_SIDED|95.0|0.489|1.193|||Log Rank|Significance threshold = 5%||||1.193|0.489|0.235
91572460|NCT01385748|183034053|SUPERIORITY_OR_OTHER|||||||0.176|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.176
91572461|NCT01385748|183034053|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.61
91572462|NCT01385748|183034053|SUPERIORITY_OR_OTHER|||||||0.295|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.295
91572463|NCT01385748|183034054|SUPERIORITY_OR_OTHER|||||||0.063||||||Significance threshold = 5%|Chi-squared|||||||0.063
91572464|NCT01385748|183034054|SUPERIORITY_OR_OTHER|||||||0.169|||||||Chi-squared|||||||0.169
91572465|NCT01385748|183034054|SUPERIORITY_OR_OTHER|||||||0.064|||||||Chi-squared|Significance threshold = 5%||||||0.064
91572466|NCT01385748|183034055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.388|TWO_SIDED|95.0|0.484|1.401|||Log Rank|Significance threshold = 5%||||1.401|0.484|0.388
91572467|NCT01385748|183034055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.054|TWO_SIDED|95.0|0.357|1.012|||Log Rank|Significance threshold = 5%||||1.012|0.357|0.054
91572468|NCT01385748|183034055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.102|TWO_SIDED|95.0|0.444|1.078|||Log Rank|Significance threshold = 5%||||1.078|0.444|0.102
91572469|NCT00159263|183034057|OTHER|Friedman ANOVA followed Dunn's pairwise comparisons||||||0.04|||||||ANOVA|||||||0.04
91572470|NCT00159263|183034058|OTHER|Friedman Anova||||||0.01|||||||ANOVA|||||||0.01
91572471|NCT00159263|183034059|OTHER|Friedman Anova||||||0.04|||||||ANOVA|||||||0.04
91572472|NCT02869867|183034153|SUPERIORITY||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.09|4.31|||Mixed Models Analysis|||||4.31|2.09|<0.001
91572473|NCT00820664|183034156|SUPERIORITY_OR_OTHER||Least Squares Mean|0.49|||<|0.001||95.0|0.31|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.31|<0.001
91572474|NCT00820664|183034156|SUPERIORITY_OR_OTHER||Least Squares Mean|0.19||||0.032||95.0|0.02|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.02|0.032
91572475|NCT01667549|183034182|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).||||||0.02||||||Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.|planned comparison|Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||0.02
91572476|NCT01667549|183034183|OTHER||||||<|0.02|||||||ANOVA|||Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor||||<0.02
91572477|NCT01667549|183034184|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).|||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.|planned comparison|a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
91572478|NCT01667549|183034185|OTHER||||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P\<0.02 were considered significant.|planned comparison|A Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
91572479|NCT01667549|183034186|OTHER||||||<|0.05|||||||ANOVA|||General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.||||<0.05
91572480|NCT01407276|183034187|SUPERIORITY_OR_OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.8|1.11|||Geometric mean ratio (GMR)|GMR of Panel A:Panel B||||1.11|0.80|
91572481|NCT01407276|183034187|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.34|||||TWO_SIDED|90.0|1.12|1.61|||GMR of Panel C:Panel D|||||1.61|1.12|
91572482|NCT01407276|183034187|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.56|||||TWO_SIDED|90.0|1.32|1.85|||GMR of Panel E:Panel F|||||1.85|1.32|
91572483|NCT01407276|183034187|SUPERIORITY_OR_OTHER||GMR or Panel G:Panel H|1.89|||||TWO_SIDED|90.0|1.4|2.55|||GMR of Panel G:Panel H|||||2.55|1.40|
91572484|NCT01407276|183034187|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.97|||||TWO_SIDED|90.0|1.46|2.66|||GMR of Panel G:Panel H|||||2.66|1.46|
91572485|NCT01407276|183034188|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.94|||||TWO_SIDED|90.0|0.79|1.12|||GMR of Panel A:Panel B|||||1.12|0.79|
91572486|NCT01407276|183034188|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.13|||||TWO_SIDED|90.0|0.91|1.41|||GMR of Panel C:Panel D|||||1.41|0.91|
91572487|NCT01407276|183034188|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.9|||||TWO_SIDED|90.0|0.66|1.23|||GMR of Panel E:Panel F|||||1.23|0.66|
91572488|NCT01407276|183034188|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.74|||||TWO_SIDED|90.0|0.57|0.96|||GMR of Panel E:Panel F|||||0.96|0.57|
91572489|NCT01407276|183034188|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.73|||||TWO_SIDED|90.0|0.56|0.95|||GMR of Panel E:Panel F|||||0.95|0.56|
91572490|NCT01407276|183034189|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.81|1.05|||GMR of Panel A:Panel B|||||1.05|0.81|
91572491|NCT01407276|183034189|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.33||||||90.0|1.07|1.65|||GMR of Panel C:Panel D|||||1.65|1.07|
91572492|NCT01407276|183034189|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.37|||||TWO_SIDED|90.0|1.13|1.65|||GMR of Panel E:Panel F|||||1.65|1.13|
91572493|NCT01407276|183034189|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.38|||||TWO_SIDED|90.0|1.06|1.79|||GMR of Panel G:Panel H|||||1.79|1.06|
91572494|NCT01407276|183034189|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.3|||||TWO_SIDED|90.0|1.0|1.68|||GMR of Panel G:Panel H|||||1.68|1.00|
91572495|NCT01407276|183034190|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.75|1.12|||GMR of Panel A:Panel B|||||1.12|0.75|
91572496|NCT01407276|183034190|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.45|||||TWO_SIDED|90.0|1.19|1.76|||GMR of Panel C:Panel D|||||1.76|1.19|
91572497|NCT01407276|183034190|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.83|||||TWO_SIDED|90.0|1.49|2.24|||GMR of Panel E:Panel F|||||2.24|1.49|
91572498|NCT01407276|183034190|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.9|||||TWO_SIDED|90.0|1.41|2.54|||GMR of Panel G:Panel H|||||2.54|1.41|
91572499|NCT01407276|183034190|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.88|||||TWO_SIDED|90.0|1.4|2.52|||GMR of Panel G:Panel H|||||2.52|1.40|
91572500|NCT01407276|183034191|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.11|||||TWO_SIDED|90.0|0.87|1.42|||GMR of Panel A:Panel B|||||1.42|0.87|
91572501|NCT01407276|183034191|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.53|1.07|||GMR of Panel C:Panel D|||||1.07|0.53|
91572502|NCT01407276|183034191|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.68|||||TWO_SIDED|90.0|0.51|0.92|||GMR of Panel E:Panel F|||||0.92|0.51|
91572503|NCT01407276|183034191|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.7|||||TWO_SIDED|90.0|0.5|0.98|||GMR of Panel G:Panel H|||||0.98|0.50|
91572504|NCT01407276|183034191|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.8|||||TWO_SIDED|90.0|0.57|1.12|||GMR of Panel G:Panel H|||||1.12|0.57|
91572505|NCT01407276|183034192|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.06|||||TWO_SIDED|90.0|0.9|1.25|||GMR of Panel A:Panel B|||||1.25|0.90|
91572506|NCT01407276|183034192|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.62|0.89|||GMR of Panel C:Panel D|||||0.89|0.62|
91572507|NCT01407276|183034192|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.64|||||TWO_SIDED|90.0|0.54|0.76|||GMR of Panel E:Panel F|||||0.76|0.54|
91572508|NCT01407276|183034192|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.53|||||TWO_SIDED|90.0|0.39|0.71|||GMR of Panel G:Panel H|||||0.71|0.39|
91572509|NCT01407276|183034192|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.51|||||TWO_SIDED|90.0|0.38|0.68|||GMR of Panel G:Panel H|||||0.68|0.38|
91572510|NCT01407276|183034193|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.93|||||TWO_SIDED|90.0|0.74|1.18|||GMR of Panel A:Panel B|||||1.18|0.74|
91572511|NCT01407276|183034193|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.73|||||TWO_SIDED|90.0|0.55|0.96|||GMR of Panel C:Panel D|||||0.96|0.55|
91572512|NCT01407276|183034193|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.42|||||TWO_SIDED|90.0|0.33|0.54|||GMR of Panel E:Panel F|||||0.54|0.33|
91572513|NCT01407276|183034194|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
91572514|NCT01407276|183034194|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
91572515|NCT01407276|183034194|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
91572516|NCT01407276|183034195|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
91572517|NCT01407276|183034195|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
91572518|NCT01407276|183034195|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
91572519|NCT04092452|183034209|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|9.69||0.4696|TWO_SIDED|90.0|-15.2|16.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||16.7|-15.2|0.4696
91572520|NCT04092452|183034209|SUPERIORITY||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|9.71||0.0298|TWO_SIDED|90.0|2.7|34.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||34.6|2.7|0.0298
91572521|NCT04092452|183034209|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.79||0.3606|TWO_SIDED|90.0|-12.6|19.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||19.6|-12.6|0.3606
91572522|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|90.0|-15.6|8.0||||||Week 1||8.0|-15.6|
91572523|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|7.28|||TWO_SIDED|90.0|-12.9|11.1||||||Week 1||11.1|-12.9|
91572524|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|90.0|-8.5|17.8||||||Week 1||17.8|-8.5|
91572525|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|7.9|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|90.0|-6.9|22.8||||||Week 2||22.8|-6.9|
91572526|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|8.91|||TWO_SIDED|90.0|-7.1|22.2||||||Week 2||22.2|-7.1|
91572527|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|-11.3|18.3||||||Week 2||18.3|-11.3|
91572528|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|9.0|STANDARD_ERROR_OF_MEAN|9.79|||TWO_SIDED|90.0|-7.1|25.1||||||Week 4||25.1|-7.1|
91572529|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|90.0|-8.0|23.5||||||Week 4||23.5|-8.0|
91572530|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|9.37|||TWO_SIDED|90.0|-19.4|11.4||||||Week 4||11.4|-19.4|
91572531|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|0.8|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|-15.6|17.2||||||Week 6||17.2|-15.6|
91572532|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|6.7|STANDARD_ERROR_OF_MEAN|9.81|||TWO_SIDED|90.0|-9.4|22.9||||||Week 6||22.9|-9.4|
91572533|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|3.7|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|90.0|-12.8|20.2||||||Week 6||20.2|-12.8|
91572534|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-7.8|STANDARD_ERROR_OF_MEAN|9.98||0.7798|TWO_SIDED|90.0|-24.2|8.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||8.7|-24.2|0.7798
91572535|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|9.92||0.4819|TWO_SIDED|90.0|-15.9|16.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||16.8|-15.9|0.4819
91572536|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|10.19||0.5933|TWO_SIDED|90.0|-19.2|14.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||14.4|-19.2|0.5933
91572537|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-9.9|STANDARD_ERROR_OF_MEAN|9.81||0.8421|TWO_SIDED|90.0|-26.1|6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||6.2|-26.1|0.8421
91572538|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|8.0|STANDARD_ERROR_OF_MEAN|9.85||0.209|TWO_SIDED|90.0|-8.2|24.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||24.2|-8.2|0.2090
91572539|NCT04092452|183034210|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|10.12||0.5183|TWO_SIDED|90.0|-17.1|16.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.2|-17.1|0.5183
91572540|NCT04092452|183034211|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|7.54||0.515|TWO_SIDED|90.0|-12.7|12.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||12.1|-12.7|0.5150
91572541|NCT04092452|183034211|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|8.28||0.0737|TWO_SIDED|90.0|-1.4|25.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||25.8|-1.4|0.0737
91572542|NCT04092452|183034211|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|8.11||0.2081|TWO_SIDED|90.0|-6.7|20.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||20.0|-6.7|0.2081
91572543|NCT04092452|183034211|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|8.9||0.2957|TWO_SIDED|90.0|-9.9|19.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||19.4|-9.9|0.2957
91572544|NCT04092452|183034211|SUPERIORITY||Risk Difference (RD)|15.6|STANDARD_ERROR_OF_MEAN|9.07||0.0456|TWO_SIDED|90.0|0.7|30.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||30.5|0.7|0.0456
91572545|NCT04092452|183034211|SUPERIORITY||Risk Difference (RD)|9.2|STANDARD_ERROR_OF_MEAN|9.05||0.1558|TWO_SIDED|90.0|-5.7|24.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||24.1|-5.7|0.1558
91572546|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-11.98|STANDARD_ERROR_OF_MEAN|8.622|||TWO_SIDED|90.0|-26.16|2.2||||||Week 1||2.20|-26.16|
91572547|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|8.526|||TWO_SIDED|90.0|-29.09|-1.04||||||Week 1||-1.04|-29.09|
91572548|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-17.45|STANDARD_ERROR_OF_MEAN|8.758|||TWO_SIDED|90.0|-31.86|-3.05||||||Week 1||-3.05|-31.86|
91572549|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|9.465|||TWO_SIDED|90.0|-28.09|3.05||||||Week 2||3.05|-28.09|
91572550|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-2.86|STANDARD_ERROR_OF_MEAN|9.338|||TWO_SIDED|90.0|-18.22|12.5||||||Week 2||12.50|-18.22|
91572551|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-5.5|STANDARD_ERROR_OF_MEAN|9.438|||TWO_SIDED|90.0|-21.02|10.03||||||Week 2||10.03|-21.02|
91572552|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-4.52|STANDARD_ERROR_OF_MEAN|11.214|||TWO_SIDED|90.0|-22.96|13.93||||||Week 4||13.93|-22.96|
91572553|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-17.54|STANDARD_ERROR_OF_MEAN|11.131|||TWO_SIDED|90.0|-35.84|0.77||||||Week 4||0.77|-35.84|
91572554|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-3.92|STANDARD_ERROR_OF_MEAN|11.507|||TWO_SIDED|90.0|-22.85|15.0||||||Week 4||15.00|-22.85|
91572555|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|7.09|STANDARD_ERROR_OF_MEAN|13.452|||TWO_SIDED|90.0|-15.04|29.22||||||Week 6||29.22|-15.04|
91572556|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-14.57|STANDARD_ERROR_OF_MEAN|13.688|||TWO_SIDED|90.0|-37.08|7.95||||||Week 6||7.95|-37.08|
91572557|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-8.95|STANDARD_ERROR_OF_MEAN|13.808|||TWO_SIDED|90.0|-31.66|13.76||||||Week 6||13.76|-31.66|
91572558|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|13.057||0.8108|TWO_SIDED|90.0|-9.98|32.98||One-sided p-value|ANCOVA|||Week 8||32.98|-9.98|0.8108
91572559|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-16.15|STANDARD_ERROR_OF_MEAN|12.845||0.1043|TWO_SIDED|90.0|-37.28|4.98||One-sided p-value|ANCOVA|||Week 8||4.98|-37.28|0.1043
91572560|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|13.355||0.1296|TWO_SIDED|90.0|-37.04|6.9||One-sided p-value|ANCOVA|||Week 8||6.90|-37.04|0.1296
91572561|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-6.54|STANDARD_ERROR_OF_MEAN|16.384||0.345|TWO_SIDED|90.0|-33.49|20.42||One-sided p-value|ANCOVA|||Week 12||20.42|-33.49|0.3450
91572562|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-17.18|STANDARD_ERROR_OF_MEAN|14.116||0.1119|TWO_SIDED|90.0|-40.4|6.04||One-sided p-value|ANCOVA|||Week 12||6.04|-40.40|0.1119
91572563|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-19.99|STANDARD_ERROR_OF_MEAN|14.806||0.0885|TWO_SIDED|90.0|-44.34|4.37||One-sided p-value|ANCOVA|||Week 12||4.37|-44.34|0.0885
91572564|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|10.85|STANDARD_ERROR_OF_MEAN|20.14||0.705|TWO_SIDED|90.0|-22.28|43.98||One-sided p-value|ANCOVA|||Week 16||43.98|-22.28|0.7050
91572565|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-17.62|STANDARD_ERROR_OF_MEAN|19.519||0.1833|TWO_SIDED|90.0|-49.73|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-49.73|0.1833
91572566|NCT04092452|183034212|SUPERIORITY||Risk Difference (RD)|-9.41|STANDARD_ERROR_OF_MEAN|20.277||0.3213|TWO_SIDED|90.0|-42.76|23.94||One-sided p-value|ANCOVA|||Week 16||23.94|-42.76|0.3213
91572567|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
91572568|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|90.0|-6.3|2.2||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.2|-6.3|
91572569|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
91572570|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|90.0|-5.2|3.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||3.3|-5.2|
91572571|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|-4.3|4.1||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.1|-4.3|
91572572|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|90.0|-4.3|4.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.3|-4.3|
91572573|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|90.0|-4.5|3.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||3.8|-4.5|
91572574|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|90.0|-5.4|2.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||2.8|-5.4|
91572575|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-4.5|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|90.0|-8.8|-0.3||||||Week 4 - Statistical Analysis (MI) - Absolute Score||-0.3|-8.8|
91572576|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-1.6|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-6.5|3.3||||||Week 6 - Statistical Analysis (MI) - Absolute Score||3.3|-6.5|
91572577|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-4.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|90.0|-9.5|0.1||||||Week 6 - Statistical Analysis (MI) - Absolute Score||0.1|-9.5|
91572578|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-5.4|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|90.0|-10.5|-0.4||||||Week 6 - Statistical Analysis (MI) - Absolute Score||-0.4|-10.5|
91572579|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|1.0|STANDARD_ERROR_OF_MEAN|2.78||0.6393|TWO_SIDED|90.0|-3.6|5.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||5.6|-3.6|0.6393
91572580|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|2.72||0.5178|TWO_SIDED|90.0|-4.4|4.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||4.6|-4.4|0.5178
91572581|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|2.82||0.0864|TWO_SIDED|90.0|-8.5|0.8||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||0.8|-8.5|0.0864
91572582|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|2.61||0.3172|TWO_SIDED|90.0|-5.5|3.1||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||3.1|-5.5|0.3172
91572583|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-2.7|STANDARD_ERROR_OF_MEAN|2.51||0.1384|TWO_SIDED|90.0|-6.8|1.4||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.4|-6.8|0.1384
91572584|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|2.66||0.1427|TWO_SIDED|90.0|-7.2|1.5||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.5|-7.2|0.1427
91572585|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-2.5|STANDARD_ERROR_OF_MEAN|2.99||0.1975|TWO_SIDED|90.0|-7.5|2.4||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.4|-7.5|0.1975
91572586|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|2.76||0.0755|TWO_SIDED|90.0|-8.5|0.6||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||0.6|-8.5|0.0755
91572587|NCT04092452|183034213|SUPERIORITY||Risk Difference (RD)|-2.6|STANDARD_ERROR_OF_MEAN|2.89||0.1869|TWO_SIDED|90.0|-7.3|2.2||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.2|-7.3|0.1869
91572588|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-3.65|STANDARD_ERROR_OF_MEAN|8.659|||TWO_SIDED|90.0|-17.9|10.59||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||10.59|-17.90|
91572589|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-13.77|STANDARD_ERROR_OF_MEAN|8.749|||TWO_SIDED|90.0|-28.16|0.62||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||0.62|-28.16|
91572590|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-17.51|STANDARD_ERROR_OF_MEAN|8.752|||TWO_SIDED|90.0|-31.91|-3.12||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||-3.12|-31.91|
91572591|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-4.29|STANDARD_ERROR_OF_MEAN|10.103|||TWO_SIDED|90.0|-20.91|12.33||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||12.33|-20.91|
91572592|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-2.05|STANDARD_ERROR_OF_MEAN|9.904|||TWO_SIDED|90.0|-18.34|14.24||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||14.24|-18.34|
91572593|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|10.039|||TWO_SIDED|90.0|-16.34|16.68||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||16.68|-16.34|
91572594|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|10.227|||TWO_SIDED|90.0|-17.29|16.36||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||16.36|-17.29|
91572595|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-8.07|STANDARD_ERROR_OF_MEAN|10.155|||TWO_SIDED|90.0|-24.77|8.63||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||8.63|-24.77|
91572596|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-6.06|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|90.0|-23.35|11.22||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||11.22|-23.35|
91572597|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-3.54|STANDARD_ERROR_OF_MEAN|12.262|||TWO_SIDED|90.0|-23.71|16.63||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||16.63|-23.71|
91572598|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-16.26|STANDARD_ERROR_OF_MEAN|12.51|||TWO_SIDED|90.0|-36.84|4.32||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||4.32|-36.84|
91572599|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|12.61|||TWO_SIDED|90.0|-33.27|8.22||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||8.22|-33.27|
91572600|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|5.79|STANDARD_ERROR_OF_MEAN|11.045||0.7|TWO_SIDED|90.0|-12.38|23.96||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||23.96|-12.38|0.7000
91572601|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-5.81|STANDARD_ERROR_OF_MEAN|10.876||0.2965|TWO_SIDED|90.0|-23.7|12.08||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||12.08|-23.70|0.2965
91572602|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-11.33|STANDARD_ERROR_OF_MEAN|11.247||0.1568|TWO_SIDED|90.0|-29.83|7.17||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||7.17|-29.83|0.1568
91572603|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-6.78|STANDARD_ERROR_OF_MEAN|10.912||0.2672|TWO_SIDED|90.0|-24.73|11.17||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||11.17|-24.73|0.2672
91572604|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-16.57|STANDARD_ERROR_OF_MEAN|10.517||0.0576|TWO_SIDED|90.0|-33.87|0.73||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||0.73|-33.87|0.0576
91572605|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-13.65|STANDARD_ERROR_OF_MEAN|11.603||0.1197|TWO_SIDED|90.0|-32.74|5.44||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||5.44|-32.74|0.1197
91572606|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-5.63|STANDARD_ERROR_OF_MEAN|13.545||0.3388|TWO_SIDED|90.0|-27.91|16.65||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||16.65|-27.91|0.3388
91572607|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-14.8|STANDARD_ERROR_OF_MEAN|13.567||0.1376|TWO_SIDED|90.0|-37.12|7.51||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||7.51|-37.12|0.1376
91572608|NCT04092452|183034214|SUPERIORITY||Risk Difference (RD)|-8.32|STANDARD_ERROR_OF_MEAN|13.86||0.2741|TWO_SIDED|90.0|-31.12|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-31.12|0.2741
91572609|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|7.06|||TWO_SIDED|90.0|-13.0|10.3||||||Week 4||10.3|-13.0|
91572610|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|90.0|-18.7|1.8||||||Week 4||1.8|-18.7|
91572611|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|7.55|||TWO_SIDED|90.0|-10.7|14.1||||||Week 4||14.1|-10.7|
91572612|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|6.8||0.8372|TWO_SIDED|90.0|-4.6|17.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||17.7|-4.6|0.8372
91572613|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-6.4|STANDARD_ERROR_OF_MEAN|4.68||0.0819|TWO_SIDED|90.0|-14.1|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||1.3|-14.1|0.0819
91572614|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|4.34||0.0242|TWO_SIDED|90.0|-15.2|-0.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||-0.9|-15.2|0.0242
91572615|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-12.7|STANDARD_ERROR_OF_MEAN|6.33||0.0264|TWO_SIDED|90.0|-23.1|-2.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-2.3|-23.1|0.0264
91572616|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-14.5|STANDARD_ERROR_OF_MEAN|6.47||0.0127|TWO_SIDED|90.0|-25.1|-3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-3.9|-25.1|0.0127
91572617|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-16.6|STANDARD_ERROR_OF_MEAN|6.33||0.0059|TWO_SIDED|90.0|-27.0|-6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-6.2|-27.0|0.0059
91572618|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-9.6|STANDARD_ERROR_OF_MEAN|7.97||0.1185|TWO_SIDED|90.0|-22.7|3.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||3.5|-22.7|0.1185
91572619|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|6.39||0.004|TWO_SIDED|90.0|-26.6|-5.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-5.6|-26.6|0.0040
91572620|NCT04092452|183034215|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|7.09||0.0418|TWO_SIDED|90.0|-24.5|-1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-1.1|-24.5|0.0418
91572621|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|12.1|STANDARD_ERROR_OF_MEAN|7.75||0.0559|TWO_SIDED|90.0|-0.7|24.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||24.8|-0.7|0.0559
91572622|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|9.8|STANDARD_ERROR_OF_MEAN|7.09||0.0758|TWO_SIDED|90.0|-1.9|21.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||21.4|-1.9|0.0758
91572623|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.21||0.0637|TWO_SIDED|90.0|-0.6|23.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||23.2|-0.6|0.0637
91572624|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|4.2|STANDARD_ERROR_OF_MEAN|8.84||0.3179|TWO_SIDED|90.0|-10.3|18.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||18.8|-10.3|0.3179
91572625|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|11.0|STANDARD_ERROR_OF_MEAN|8.82||0.1078|TWO_SIDED|90.0|-3.5|25.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||25.5|-3.5|0.1078
91572626|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|8.86||0.1976|TWO_SIDED|90.0|-7.0|22.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||22.2|-7.0|0.1976
91572627|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-18.9|STANDARD_ERROR_OF_MEAN|9.32||0.9738|TWO_SIDED|90.0|-34.3|-3.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||-3.6|-34.3|0.9738
91572628|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|10.4||0.2925|TWO_SIDED|90.0|-11.3|22.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||22.9|-11.3|0.2925
91572629|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-3.1|STANDARD_ERROR_OF_MEAN|10.18||0.6178|TWO_SIDED|90.0|-19.8|13.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||13.7|-19.8|0.6178
91572630|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-20.9|STANDARD_ERROR_OF_MEAN|10.04||0.9769|TWO_SIDED|90.0|-37.4|-4.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||-4.4|-37.4|0.9769
91572631|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-4.2|STANDARD_ERROR_OF_MEAN|10.57||0.6529|TWO_SIDED|90.0|-21.6|13.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||13.2|-21.6|0.6529
91572632|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|10.36||0.8878|TWO_SIDED|90.0|-29.8|4.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||4.3|-29.8|0.8878
91572633|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-6.2|STANDARD_ERROR_OF_MEAN|10.11||0.7259|TWO_SIDED|90.0|-22.9|10.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||10.4|-22.9|0.7259
91572634|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|14.8|STANDARD_ERROR_OF_MEAN|10.24||0.0826|TWO_SIDED|90.0|-2.1|31.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||31.6|-2.1|0.0826
91572635|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|9.75||0.7884|TWO_SIDED|90.0|-24.1|8.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||8.0|-24.1|0.7884
91572636|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|10.43||0.9326|TWO_SIDED|90.0|-33.2|1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||1.1|-33.2|0.9326
91572637|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-4.9|STANDARD_ERROR_OF_MEAN|10.41||0.681|TWO_SIDED|90.0|-22.1|12.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||12.2|-22.1|0.6810
91572638|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.52||0.8308|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||7.0|-27.6|0.8308
91572639|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|9.71||0.8063|TWO_SIDED|90.0|-24.5|7.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||7.4|-24.5|0.8063
91572640|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|10.27||0.2649|TWO_SIDED|90.0|-10.4|23.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||23.4|-10.4|0.2649
91572641|NCT04092452|183034216|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|10.35||0.3029|TWO_SIDED|90.0|-11.7|22.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||22.4|-11.7|0.3029
91572642|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|8.2||0.1687|TWO_SIDED|90.0|-5.7|21.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||21.2|-5.7|0.1687
91572643|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|13.8|STANDARD_ERROR_OF_MEAN|8.03||0.0376|TWO_SIDED|90.0|0.6|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||27.0|0.6|0.0376
91572644|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|6.9||0.5883|TWO_SIDED|90.0|-12.9|9.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||9.8|-12.9|0.5883
91572645|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|9.07||0.3829|TWO_SIDED|90.0|-12.2|17.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||17.6|-12.2|0.3829
91572646|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|9.54||0.0316|TWO_SIDED|90.0|2.5|33.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||33.9|2.5|0.0316
91572647|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|9.17||0.3072|TWO_SIDED|90.0|-10.5|19.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||19.7|-10.5|0.3072
91572648|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-13.1|STANDARD_ERROR_OF_MEAN|10.18||0.8952|TWO_SIDED|90.0|-29.8|3.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||3.7|-29.8|0.8952
91572649|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|10.76||0.1157|TWO_SIDED|90.0|-4.6|30.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||30.8|-4.6|0.1157
91572650|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|10.93||0.4672|TWO_SIDED|90.0|-17.1|18.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||18.9|-17.1|0.4672
91572651|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-16.9|STANDARD_ERROR_OF_MEAN|11.29||0.9287|TWO_SIDED|90.0|-35.5|1.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||1.6|-35.5|0.9287
91572652|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|10.85||0.4984|TWO_SIDED|90.0|-17.8|17.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||17.9|-17.8|0.4984
91572653|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-14.7|STANDARD_ERROR_OF_MEAN|11.27||0.9001|TWO_SIDED|90.0|-33.2|3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||3.9|-33.2|0.9001
91572654|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.53||0.8319|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||7.0|-27.6|0.8319
91572655|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|19.7|STANDARD_ERROR_OF_MEAN|10.55||0.034|TWO_SIDED|90.0|2.3|37.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||37.0|2.3|0.0340
91572656|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-6.8|STANDARD_ERROR_OF_MEAN|10.7||0.7359|TWO_SIDED|90.0|-24.4|10.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||10.8|-24.4|0.7359
91572657|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-16.0|STANDARD_ERROR_OF_MEAN|10.51||0.9291|TWO_SIDED|90.0|-33.3|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||1.3|-33.3|0.9291
91572658|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|10.44||0.5087|TWO_SIDED|90.0|-17.4|16.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||16.9|-17.4|0.5087
91572659|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-9.5|STANDARD_ERROR_OF_MEAN|10.74||0.8098|TWO_SIDED|90.0|-27.2|8.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||8.1|-27.2|0.8098
91572660|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|-8.8|STANDARD_ERROR_OF_MEAN|9.76||0.8114|TWO_SIDED|90.0|-24.8|7.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||7.2|-24.8|0.8114
91572661|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|10.8|STANDARD_ERROR_OF_MEAN|10.44||0.1531|TWO_SIDED|90.0|-6.4|28.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||28.0|-6.4|0.1531
91572662|NCT04092452|183034217|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|10.58||0.3784|TWO_SIDED|90.0|-14.1|20.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||20.7|-14.1|0.3784
91572663|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-7.44|STANDARD_ERROR_OF_MEAN|6.661||0.1321|TWO_SIDED|90.0|-18.39|3.52||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||3.52|-18.39|0.1321
91572664|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-10.52|STANDARD_ERROR_OF_MEAN|6.308||0.0477|TWO_SIDED|90.0|-20.9|-0.14||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-0.14|-20.90|0.0477
91572665|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-14.13|STANDARD_ERROR_OF_MEAN|6.379||0.0134|TWO_SIDED|90.0|-24.62|-3.63||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-3.63|-24.62|0.0134
91572666|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-5.66|STANDARD_ERROR_OF_MEAN|8.38||0.2496|TWO_SIDED|90.0|-19.45|8.12||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||8.12|-19.45|0.2496
91572667|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-11.92|STANDARD_ERROR_OF_MEAN|7.972||0.0675|TWO_SIDED|90.0|-25.03|1.2||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.20|-25.03|0.0675
91572668|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-11.71|STANDARD_ERROR_OF_MEAN|8.054||0.073|TWO_SIDED|90.0|-24.96|1.54||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.54|-24.96|0.0730
91572669|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|3.25|STANDARD_ERROR_OF_MEAN|8.892||0.6426|TWO_SIDED|90.0|-11.38|17.88||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||17.88|-11.38|0.6426
91572670|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-7.82|STANDARD_ERROR_OF_MEAN|8.457||0.1776|TWO_SIDED|90.0|-21.73|6.09||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||6.09|-21.73|0.1776
91572671|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-1.17|STANDARD_ERROR_OF_MEAN|8.579||0.4458|TWO_SIDED|90.0|-15.28|12.94||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||12.94|-15.28|0.4458
91572672|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|7.94|STANDARD_ERROR_OF_MEAN|9.566||0.7969|TWO_SIDED|90.0|-7.79|23.68||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||23.68|-7.79|0.7969
91572673|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-11.09|STANDARD_ERROR_OF_MEAN|9.12||0.112|TWO_SIDED|90.0|-26.09|3.91||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||3.91|-26.09|0.1120
91572674|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|9.188||0.5021|TWO_SIDED|90.0|-15.06|15.16||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||15.16|-15.06|0.5021
91572675|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|2.83|STANDARD_ERROR_OF_MEAN|9.296||0.6197|TWO_SIDED|90.0|-12.46|18.12||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||18.12|-12.46|0.6197
91572676|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-11.3|STANDARD_ERROR_OF_MEAN|8.825||0.1003|TWO_SIDED|90.0|-25.81|3.22||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||3.22|-25.81|0.1003
91572677|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|8.908||0.507|TWO_SIDED|90.0|-14.5|14.81||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||14.81|-14.50|0.5070
91572678|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|0.67|STANDARD_ERROR_OF_MEAN|9.368||0.5283|TWO_SIDED|90.0|-14.74|16.08||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||16.08|-14.74|0.5283
91572679|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-15.31|STANDARD_ERROR_OF_MEAN|8.921||0.0431|TWO_SIDED|90.0|-29.98|-0.63||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||-0.63|-29.98|0.0431
91572680|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-6.39|STANDARD_ERROR_OF_MEAN|9.02||0.2395|TWO_SIDED|90.0|-21.22|8.45||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||8.45|-21.22|0.2395
91572681|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|2.57|STANDARD_ERROR_OF_MEAN|9.617||0.6054|TWO_SIDED|90.0|-13.25|18.39||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||18.39|-13.25|0.6054
91572682|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-21.54|STANDARD_ERROR_OF_MEAN|9.344||0.0106|TWO_SIDED|90.0|-36.91|-6.17||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-6.17|-36.91|0.0106
91572683|NCT04092452|183034218|SUPERIORITY||Risk Difference (RD)|-12.54|STANDARD_ERROR_OF_MEAN|9.305||0.089|TWO_SIDED|90.0|-27.84|2.77||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||2.77|-27.84|0.0890
91572684|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-6.17|STANDARD_ERROR_OF_MEAN|5.963||0.1505|TWO_SIDED|90.0|-15.98|3.64||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.64|-15.98|0.1505
91572685|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-11.06|STANDARD_ERROR_OF_MEAN|5.555||0.0233|TWO_SIDED|90.0|-20.19|-1.92||One-sided p-value|ANCOVA|||Week 1 Average Pain||-1.92|-20.19|0.0233
91572686|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-6.34|STANDARD_ERROR_OF_MEAN|5.926||0.1423|TWO_SIDED|90.0|-16.09|3.41||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.41|-16.09|0.1423
91572687|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-2.15|STANDARD_ERROR_OF_MEAN|7.202||0.3827|TWO_SIDED|90.0|-14.0|9.7||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.70|-14.00|0.3827
91572688|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-10.35|STANDARD_ERROR_OF_MEAN|6.741||0.0624|TWO_SIDED|90.0|-21.44|0.74||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.74|-21.44|0.0624
91572689|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-2.25|STANDARD_ERROR_OF_MEAN|7.171||0.3771|TWO_SIDED|90.0|-14.04|9.55||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.55|-14.04|0.3771
91572690|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|8.04|STANDARD_ERROR_OF_MEAN|8.614||0.8247|TWO_SIDED|90.0|-6.13|22.21||One-sided p-value|ANCOVA|||Week 4 Average Pain||22.21|-6.13|0.8247
91572691|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-8.97|STANDARD_ERROR_OF_MEAN|8.09||0.1337|TWO_SIDED|90.0|-22.28|4.33||One-sided p-value|ANCOVA|||Week 4 Average Pain||4.33|-22.28|0.1337
91572692|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|5.37|STANDARD_ERROR_OF_MEAN|8.523||0.7357|TWO_SIDED|90.0|-8.65|19.39||One-sided p-value|ANCOVA|||Week 4 Average Pain||19.39|-8.65|0.7357
91572693|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|13.78|STANDARD_ERROR_OF_MEAN|8.977||0.9377|TWO_SIDED|90.0|-0.98|28.55||One-sided p-value|ANCOVA|||Week 6 Average Pain||28.55|-0.98|0.9377
91572694|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-9.39|STANDARD_ERROR_OF_MEAN|8.45||0.1332|TWO_SIDED|90.0|-23.29|4.51||One-sided p-value|ANCOVA|||Week 6 Average Pain||4.51|-23.29|0.1332
91572695|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|6.05|STANDARD_ERROR_OF_MEAN|8.907||0.7514|TWO_SIDED|90.0|-8.6|20.7||One-sided p-value|ANCOVA|||Week 6 Average Pain||20.70|-8.60|0.7514
91572696|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|8.97|STANDARD_ERROR_OF_MEAN|8.902||0.8433|TWO_SIDED|90.0|-5.67|23.62||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.62|-5.67|0.8433
91572697|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-8.84|STANDARD_ERROR_OF_MEAN|8.392||0.1461|TWO_SIDED|90.0|-22.64|4.96||One-sided p-value|ANCOVA|||Week 8 Average Pain||4.96|-22.64|0.1461
91572698|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|8.64|STANDARD_ERROR_OF_MEAN|8.818||0.8364|TWO_SIDED|90.0|-5.86|23.15||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.15|-5.86|0.8364
91572699|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|2.35|STANDARD_ERROR_OF_MEAN|8.527||0.6085|TWO_SIDED|90.0|-11.68|16.37||One-sided p-value|ANCOVA|||Week 12 Average Pain||16.37|-11.68|0.6085
91572700|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-14.38|STANDARD_ERROR_OF_MEAN|8.022||0.0365|TWO_SIDED|90.0|-27.58|-1.19||One-sided p-value|ANCOVA|||Week 12 Average Pain||-1.19|-27.58|0.0365
91572701|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|8.469||0.5201|TWO_SIDED|90.0|-13.5|14.36||One-sided p-value|ANCOVA|||Week 12 Average Pain||14.36|-13.50|0.5201
91572702|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|4.04|STANDARD_ERROR_OF_MEAN|8.564||0.6813|TWO_SIDED|90.0|-10.05|18.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||18.12|-10.05|0.6813
91572703|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-18.38|STANDARD_ERROR_OF_MEAN|8.23||0.0128|TWO_SIDED|90.0|-31.91|-4.84||One-sided p-value|ANCOVA|||Week 16 Average Pain||-4.84|-31.91|0.0128
91572704|NCT04092452|183034219|SUPERIORITY||Risk Difference (RD)|-4.09|STANDARD_ERROR_OF_MEAN|8.639||0.3181|TWO_SIDED|90.0|-18.3|10.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||10.12|-18.30|0.3181
91572705|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.301||0.1536|TWO_SIDED|90.0|-0.8|0.19||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.19|-0.80|0.1536
91572706|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.289||0.0581|TWO_SIDED|90.0|-0.93|0.02||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.02|-0.93|0.0581
91572707|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.3||0.0532|TWO_SIDED|90.0|-0.98|0.01||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.01|-0.98|0.0532
91572708|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.383||0.2007|TWO_SIDED|90.0|-0.95|0.31||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.31|-0.95|0.2007
91572709|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.55|STANDARD_ERROR_OF_MEAN|0.37||0.0694|TWO_SIDED|90.0|-1.16|0.06||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.06|-1.16|0.0694
91572710|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.382||0.1509|TWO_SIDED|90.0|-1.02|0.23||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.23|-1.02|0.1509
91572711|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.431||0.5663|TWO_SIDED|90.0|-0.64|0.78||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.78|-0.64|0.5663
91572712|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.416||0.1396|TWO_SIDED|90.0|-1.13|0.23||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.23|-1.13|0.1396
91572713|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.432||0.5227|TWO_SIDED|90.0|-0.69|0.74||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.74|-0.69|0.5227
91572714|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8656|TWO_SIDED|90.0|-0.24|1.24||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||1.24|-0.24|0.8656
91572715|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.434||0.1671|TWO_SIDED|90.0|-1.13|0.29||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.29|-1.13|0.1671
91572716|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.45||0.6063|TWO_SIDED|90.0|-0.62|0.86||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.86|-0.62|0.6063
91572717|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.458||0.6402|TWO_SIDED|90.0|-0.59|0.92||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.92|-0.59|0.6402
91572718|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.38|STANDARD_ERROR_OF_MEAN|0.441||0.1916|TWO_SIDED|90.0|-1.11|0.34||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.34|-1.11|0.1916
91572719|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.456||0.6119|TWO_SIDED|90.0|-0.62|0.88||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.88|-0.62|0.6119
91572720|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.45||0.5568|TWO_SIDED|90.0|-0.68|0.8||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.80|-0.68|0.5568
91572721|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.433||0.0976|TWO_SIDED|90.0|-1.27|0.15||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.15|-1.27|0.0976
91572722|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.451||0.5001|TWO_SIDED|90.0|-0.74|0.74||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.74|-0.74|0.5001
91572723|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.451||0.581|TWO_SIDED|90.0|-0.65|0.83||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.83|-0.65|0.5810
91572724|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-1.07|STANDARD_ERROR_OF_MEAN|0.442||0.0079|TWO_SIDED|90.0|-1.8|-0.34||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-0.34|-1.80|0.0079
91572725|NCT04092452|183034220|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.455||0.1068|TWO_SIDED|90.0|-1.31|0.18||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.18|-1.31|0.1068
91572726|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.284||0.1898|TWO_SIDED|90.0|-0.72|0.22||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.22|-0.72|0.1898
91572727|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.273||0.0562|TWO_SIDED|90.0|-0.88|0.02||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.02|-0.88|0.0562
91572728|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.284||0.1382|TWO_SIDED|90.0|-0.78|0.16||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.16|-0.78|0.1382
91572729|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.343||0.2039|TWO_SIDED|90.0|-0.85|0.28||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.28|-0.85|0.2039
91572730|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.332||0.0855|TWO_SIDED|90.0|-1.0|0.09||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.09|-1.00|0.0855
91572731|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.344||0.3089|TWO_SIDED|90.0|-0.74|0.39||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.39|-0.74|0.3089
91572732|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.407||0.6124|TWO_SIDED|90.0|-0.55|0.79||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.79|-0.55|0.6124
91572733|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|0.395||0.1003|TWO_SIDED|90.0|-1.15|0.14||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.14|-1.15|0.1003
91572734|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.408||0.6875|TWO_SIDED|90.0|-0.47|0.87||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.87|-0.47|0.6875
91572735|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.51|STANDARD_ERROR_OF_MEAN|0.427||0.8833|TWO_SIDED|90.0|-0.19|1.21||One-sided p-value|ANCOVA|||Week 6 Average Pain||1.21|-0.19|0.8833
91572736|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.413||0.1502|TWO_SIDED|90.0|-1.11|0.25||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.25|-1.11|0.1502
91572737|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.428||0.6788|TWO_SIDED|90.0|-0.5|0.9||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.90|-0.50|0.6788
91572738|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.441||0.6835|TWO_SIDED|90.0|-0.51|0.94||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.94|-0.51|0.6835
91572739|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.425||0.2237|TWO_SIDED|90.0|-1.02|0.38||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.38|-1.02|0.2237
91572740|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.439||0.7234|TWO_SIDED|90.0|-0.46|0.98||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.98|-0.46|0.7234
91572741|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.424||0.4773|TWO_SIDED|90.0|-0.72|0.67||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.67|-0.72|0.4773
91572742|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.41||0.0818|TWO_SIDED|90.0|-1.25|0.1||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.10|-1.25|0.0818
91572743|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.424||0.6397|TWO_SIDED|90.0|-0.55|0.85||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.85|-0.55|0.6397
91572744|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.428||0.5321|TWO_SIDED|90.0|-0.67|0.74||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.74|-0.67|0.5321
91572745|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.89|STANDARD_ERROR_OF_MEAN|0.42||0.0167|TWO_SIDED|90.0|-1.59|-0.2||One-sided p-value|ANCOVA|||Week 16 Average Pain||-0.20|-1.59|0.0167
91572746|NCT04092452|183034221|SUPERIORITY||Risk Difference (RD)|-0.37|STANDARD_ERROR_OF_MEAN|0.434||0.1963|TWO_SIDED|90.0|-1.09|0.34||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.34|-1.09|0.1963
91572747|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|90.0|-10.3|6.0||||||Week 1||6.0|-10.3|
91572748|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|2.0|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-7.3|11.3||||||Week 1||11.3|-7.3|
91572749|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|6.8|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-3.9|17.4||||||Week 1||17.4|-3.9|
91572750|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|10.7|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-2.0|23.4||||||Week 2||23.4|-2.0|
91572751|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|7.34|||TWO_SIDED|90.0|-4.5|19.7||||||Week 2||19.7|-4.5|
91572752|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|7.36|||TWO_SIDED|90.0|-4.6|19.6||||||Week 2||19.6|-4.6|
91572753|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|7.4|STANDARD_ERROR_OF_MEAN|7.95|||TWO_SIDED|90.0|-5.7|20.5||||||Week 4||20.5|-5.7|
91572754|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|15.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|90.0|1.4|28.7||||||Week 4||28.7|1.4|
91572755|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-8.0|17.5||||||Week 4||17.5|-8.0|
91572756|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|14.3|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|0.7|28.0||||||Week 6||28.0|0.7|
91572757|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|7.96|||TWO_SIDED|90.0|-2.2|24.0||||||Week 6||24.0|-2.2|
91572758|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|10.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|90.0|-2.6|23.9||||||Week 6||23.9|-2.6|
91572759|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|10.1|STANDARD_ERROR_OF_MEAN|8.38||0.1162|TWO_SIDED|90.0|-3.6|23.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||23.9|-3.6|0.1162
91572760|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|8.43||0.0642|TWO_SIDED|90.0|-0.8|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||27.0|-0.8|0.0642
91572761|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|8.1|STANDARD_ERROR_OF_MEAN|8.36||0.1664|TWO_SIDED|90.0|-5.7|21.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||21.8|-5.7|0.1664
91572762|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|8.1||0.1882|TWO_SIDED|90.0|-6.1|20.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||20.5|-6.1|0.1882
91572763|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.43||0.0423|TWO_SIDED|90.0|1.1|28.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||28.8|1.1|0.0423
91572764|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|7.9||0.3396|TWO_SIDED|90.0|-9.7|16.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.3|-9.7|0.3396
91572765|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|7.35||0.3584|TWO_SIDED|90.0|-9.4|14.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||14.8|-9.4|0.3584
91572766|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.17||0.0367|TWO_SIDED|90.0|1.5|28.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||28.3|1.5|0.0367
91572767|NCT04092452|183034222|SUPERIORITY||Risk Difference (RD)|5.2|STANDARD_ERROR_OF_MEAN|7.65||0.2486|TWO_SIDED|90.0|-7.4|17.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||17.8|-7.4|0.2486
91572768|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
91572769|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
91572770|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
91572771|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
91572772|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
91572773|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
91572774|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
91572775|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
91572776|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
91572777|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
91572778|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
91572779|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
91572780|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
91572781|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
91572782|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
91572783|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
91572784|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
91572785|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
91572786|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
91572787|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
91572788|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
91572789|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
91572790|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
91572791|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
91572792|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
91572793|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
91572794|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
91572795|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
91572796|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
91572797|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
91572798|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
91572799|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
91572800|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
91572801|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
91572802|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
91572803|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
91572804|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
91572805|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
91572806|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
91572807|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
91572808|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
91572809|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
91572810|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
91572811|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
91572812|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
91572813|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
91572814|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
91572815|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
91572816|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
91572817|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
91572818|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
91572819|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
91572820|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
91572821|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
91572822|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
91572823|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
91572824|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
91572825|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
91572826|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
91572827|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
91572828|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
91572829|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
91572830|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
91572831|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
91572832|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
91572833|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
91572834|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
91572835|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
91572836|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
91572837|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
91572838|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
91572839|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
91572840|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
91572841|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
91572842|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
91572843|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
91572844|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
91572845|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
91572846|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
91572847|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
91572848|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
91572849|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
91572850|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
91572851|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
91572852|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
91572853|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
91572854|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
91572855|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
91572856|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
91572857|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
91572858|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
91572859|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
91572860|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
91572861|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
91572862|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
91572863|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
91572864|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
91572865|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
91572866|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
91572867|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
91572868|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
91572869|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
91572870|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
91572871|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
91572872|NCT04092452|183034228|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
91572873|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
91572874|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
91572875|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
91572876|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
91572877|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
91572878|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
91572879|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
91572880|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
91572881|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
91572882|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
91572883|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
91572884|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
91572885|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
91572886|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
91572887|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
91572888|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
91572889|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
91572890|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
91572891|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
91572892|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
91572893|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
91572894|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
91572895|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
91572896|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
91572897|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
91572898|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
91572899|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
91572900|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
91572901|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
91572902|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
91572903|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
91572904|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
91572905|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
91572906|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
91572907|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
91572908|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
91572909|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
91572910|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
91572911|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
91572912|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
91572913|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
91572914|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
91572915|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
91572916|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
91572917|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
91572918|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
91572919|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
91572920|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
91572921|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
91572922|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
91572923|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
91572924|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
91572925|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
91572926|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
91572927|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
91572928|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
91572929|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
91572930|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
91572931|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
91572932|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
91572933|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
91572934|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
91572935|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
91572936|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
91572937|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
91572938|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
91572939|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
91572940|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
91572941|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
91572942|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
91572943|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
91572944|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
91572945|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
91572946|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
91572947|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
91572948|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
91572949|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
91572950|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
91572951|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
91572952|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
91572953|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
91572954|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
91572955|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
91572956|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
91572957|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
91572958|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
91572959|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
91572960|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
91572961|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
91572962|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
91572963|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
91572964|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
91572965|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
91572966|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
91572967|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
91572968|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
91572969|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
91572970|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
91572971|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
91572972|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
91572973|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
91572974|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
91572975|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
91572976|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
91572977|NCT04092452|183034229|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
91572978|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
91572979|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
91572980|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
91572981|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
91572982|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
91572983|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
91572984|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
91572985|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
91572986|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
91572987|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
91572988|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
91572989|NCT04092452|183034230|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
91572990|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
91572991|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
91572992|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
91572993|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
91572994|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
91572995|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
91572996|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
91572997|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
91572998|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
91572999|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
91573000|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
91573001|NCT04092452|183034231|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
91573002|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-9.1|9.5||||||Week 4||9.5|-9.1|
91573003|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|90.0|-7.4|9.8||||||Week 4||9.8|-7.4|
91573004|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|90.0|-11.4|3.4||||||Week 4||3.4|-11.4|
91573005|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|4.3|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|90.0|-3.3|11.8||||||Week 8||11.8|-3.3|
91573006|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|6.2|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|90.0|-1.8|14.2||||||Week 8||14.2|-1.8|
91573007|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|2.5|STANDARD_DEVIATION|4.42|||TWO_SIDED|90.0|-4.8|9.8||||||Week 8||9.8|-4.8|
91573008|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.43|||TWO_SIDED|90.0|-1.3|16.5||||||Week 12||16.5|-1.3|
91573009|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|6.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-2.0|15.7||||||Week 12||15.7|-2.0|
91573010|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|2.9|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|90.0|-5.5|11.3||||||Week 12||11.3|-5.5|
91573011|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.88|||TWO_SIDED|90.0|-6.3|6.4||||||Week 16||6.4|-6.3|
91573012|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-2.8|15.7||||||Week 16||15.7|-2.8|
91573013|NCT04092452|183034232|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-1.6|16.9||||||Week 16||16.9|-1.6|
91573014|NCT02127125|183034238|SUPERIORITY||||||<|0.025||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||<0.025
91573015|NCT02127125|183034238|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
91573016|NCT02127125|183034239|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
91573017|NCT02127125|183034239|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
91573018|NCT02127125|183034240|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
91573019|NCT02127125|183034240|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
91573020|NCT01255761|183034252|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.|Difference in proportion|-0.119|||||TWO_SIDED|95.0|-0.184|-0.053||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||-0.053|-0.184|
91573021|NCT01255761|183034253|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.|Difference in proportion|-0.013|||||TWO_SIDED|95.0|-0.093|0.066||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||0.066|-0.093|
91573022|NCT00658606|183034302|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.032
91573023|NCT00658606|183034303|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||No adjustments were made to multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.037
91573024|NCT00658606|183034304|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to 'Change from Baseline'||||0.001
91573025|NCT00658606|183034305|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.382
91573026|NCT00658606|183034306|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.052
91573027|NCT00658606|183034307|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.026
91573028|NCT00658606|183034308|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'PASI 90 = Yes'||||0.147
91573029|NCT00658606|183034309|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.566
91573030|NCT00658606|183034310|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.001
91573031|NCT00658606|183034311|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.007
91573032|NCT00658606|183034312|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.539
91573033|NCT03786744|183034317|SUPERIORITY||Mean Difference (Net)|9.0||||0.049367|TWO_SIDED|||||Alternative hypothesis: can be changed of speech, language, communication skills for Cord Blood versus Placebo groups in 2-month Threshold \<0.05|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.049367
91573034|NCT03786744|183034317|SUPERIORITY||Median Difference (Net)|9.0||||0.004072|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Health/Physical Development/Behaviour for Cord Blood versus Control groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.004072
91573035|NCT03786744|183034317|SUPERIORITY||Mean Difference (Net)|9.0||||0.017258|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Health/Physical Development/Behaviour for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.017258
91573036|NCT03786744|183034317|SUPERIORITY||Mean Difference (Net)|10.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 1-month of total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
91573037|NCT03786744|183034317|SUPERIORITY||Mean Difference (Net)|24.0||||0.00194|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.001940
91573038|NCT03786744|183034317|SUPERIORITY||Mean Difference (Net)|15.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 6-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
91573039|NCT03786744|183034317|SUPERIORITY||Mean Difference (Net)|16.0||||0.01133|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.011330
91573040|NCT00569127|183034327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.55|TWO_SIDED|95.0|0.73|1.18||Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.|Regression, Cox||The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.|According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.||1.18|0.73|0.55
91573041|NCT06314438|183034358|EQUIVALENCE|paired samples t test with significance set at 0.05 p value||||||0.34|||||||t-test, 2 sided|||||||0.34
91573042|NCT06314438|183034359|EQUIVALENCE|paired samples t test with significance level at 0.05||||||0.05|||||||t-test, 2 sided|||||||0.05
91573043|NCT06314438|183034360|EQUIVALENCE|paired samples t test with significance set at 0.05 p value|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
91573044|NCT03494985|183034391|OTHER||Least square mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.9||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.4|<0.0001
91573045|NCT03494985|183034391|OTHER||LS mean difference|0.9|||<|0.0001|TWO_SIDED|95.0|0.6|1.2||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||1.2|0.6|<0.0001
91573046|NCT03494985|183034391|OTHER||LS mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.3|0.9||p-value was adjusted using Dunnett's method for multiple comparisons.|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.3|<0.0001
91573047|NCT03459846|183034405|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.789|TWO_SIDED|95.0|0.641|1.387|||Regression, Cox|||||1.387|0.641|0.789
91573048|NCT03459846|183034406|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.728|TWO_SIDED|95.0|0.719|1.606|||Regression, Cox|||||1.606|0.719|0.728
91573049|NCT03459846|183034407|SUPERIORITY||Odds Ratio (OR)|1.76||||0.142|TWO_SIDED|95.0|0.821|3.778|||Regression, Logistic|||||3.778|0.821|0.142
91573050|NCT00310180|183034420|SUPERIORITY|Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.|Hazard Ratio (HR)|1.08||||0.13|TWO_SIDED|95.0|0.94|1.24||One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.|Regression, Cox|||This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.||1.24|0.94|0.13
91573051|NCT00310180|183034424|OTHER|Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis||||||0.004|||||||Regression, Cox|||Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C||||0.004
91573052|NCT01443403|183034464|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.605||0.0003|TWO_SIDED|95.0|1.02|3.41|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.||||3.41|1.02|0.0003
91573053|NCT01443403|183034464|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.604||0.0014|TWO_SIDED|95.0|0.76|3.14|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.14|0.76|0.0014
91573054|NCT01443403|183034464|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|0.599||0.3504|TWO_SIDED|95.0|-0.62|1.74|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.74|-0.62|0.3504
91573055|NCT01443403|183034466|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|0.568||0.0008|TWO_SIDED|95.0|0.81|3.05|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.05|0.81|0.0008
91573056|NCT01443403|183034466|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.569||0.0009|TWO_SIDED|95.0|0.79|3.04|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.04|0.79|0.0009
91573057|NCT01443403|183034466|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.558||0.2572|TWO_SIDED|95.0|-0.47|1.73|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.73|-0.47|0.2572
91573058|NCT01443403|183034468|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.484||0.0065|TWO_SIDED|95.0|0.38|2.28|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.28|0.38|0.0065
91573059|NCT01443403|183034468|SUPERIORITY_OR_OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.482||0.0008|TWO_SIDED|95.0|0.69|2.58|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.58|0.69|0.0008
91573060|NCT01443403|183034468|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.476||0.2921|TWO_SIDED|95.0|-0.43|1.44|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.44|-0.43|0.2921
91573061|NCT01443403|183034470|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|STANDARD_ERROR_OF_MEAN|0.495||0.0039|TWO_SIDED|95.0|0.47|2.42|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.42|0.47|0.0039
91573062|NCT01443403|183034470|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.492||0.0007|TWO_SIDED|95.0|0.73|2.67|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.67|0.73|0.0007
91573063|NCT01443403|183034470|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.488||0.3077|TWO_SIDED|95.0|-0.46|1.46|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.46|-0.46|0.3077
91573064|NCT01443403|183034472|SUPERIORITY_OR_OTHER||Difference|27.3||||0.003|TWO_SIDED|95.0|10.0|44.6|||Chi-squared|||||44.6|10.0|0.0030
91573065|NCT01443403|183034472|SUPERIORITY_OR_OTHER||Difference|31.8||||0.0005|TWO_SIDED|95.0|15.0|48.7|||Chi-squared|||||48.7|15.0|0.0005
91573066|NCT01443403|183034472|SUPERIORITY_OR_OTHER||Difference|13.1||||0.1461|TWO_SIDED|95.0|-4.4|30.6|||Chi-squared|||||30.6|-4.4|0.1461
91573067|NCT01443403|183034474|SUPERIORITY_OR_OTHER||Difference|24.3||||0.005|TWO_SIDED|95.0|7.8|40.8|||Chi-squared|||||40.8|7.8|0.0050
91573068|NCT01443403|183034474|SUPERIORITY_OR_OTHER||Difference|24.5||||0.0045|TWO_SIDED|95.0|8.1|40.8|||Chi-squared|||||40.8|8.1|0.0045
91573069|NCT01443403|183034474|SUPERIORITY_OR_OTHER||Difference|8.2||||0.2984|TWO_SIDED|95.0|-7.2|23.6|||Chi-squared|||||23.6|-7.2|0.2984
91573070|NCT01443403|183034476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.9|2.17|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.17|0.90|<0.0001
91573071|NCT01443403|183034476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.32||0.0002|TWO_SIDED|95.0|0.59|1.85|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.85|0.59|0.0002
91573072|NCT01443403|183034476|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.317||0.0698|TWO_SIDED|95.0|-0.05|1.2|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.20|-0.05|0.0698
91573073|NCT01443403|183034478|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.307||0.0001|TWO_SIDED|95.0|0.58|1.79|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.79|0.58|0.0001
91573074|NCT01443403|183034478|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.305||0.0004|TWO_SIDED|95.0|0.49|1.7|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.70|0.49|0.0004
91573075|NCT01443403|183034478|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.302||0.1648|TWO_SIDED|95.0|-0.17|1.02|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.02|-0.17|0.1648
91573076|NCT01443403|183034480|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
91573077|NCT01443403|183034480|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91573078|NCT01443403|183034480|SUPERIORITY_OR_OTHER|||||||0.0118||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0118
91573079|NCT01443403|183034481|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91573080|NCT01443403|183034481|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0011
91573081|NCT01443403|183034481|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
91573082|NCT01443403|183034484|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.358||0.0003|TWO_SIDED|95.0|0.62|2.03|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.03|0.62|0.0003
91573083|NCT01443403|183034484|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|0.359|<|0.0001|TWO_SIDED|95.0|0.8|2.22|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.22|0.80|<0.0001
91573084|NCT01443403|183034484|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.352||0.1211|TWO_SIDED|95.0|-0.15|1.24|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.24|-0.15|0.1211
91573085|NCT01443403|183034486|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|STANDARD_ERROR_OF_MEAN|0.551|<|0.0001|TWO_SIDED|95.0|1.28|3.45|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.45|1.28|<0.0001
91573086|NCT01443403|183034486|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.549||0.0002|TWO_SIDED|95.0|0.99|3.15|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.15|0.99|0.0002
91573087|NCT01443403|183034486|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.542||0.2022|TWO_SIDED|95.0|-0.37|1.76|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.76|-0.37|0.2022
91573088|NCT01443403|183034489|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0272
91573089|NCT01443403|183034489|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1355
91573090|NCT01443403|183034489|SUPERIORITY_OR_OTHER|||||||0.3689||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3689
91573091|NCT01443403|183034491|SUPERIORITY_OR_OTHER|||||||0.2126||95.0|||||Welch's t-test|||||||0.2126
91573092|NCT01443403|183034491|SUPERIORITY_OR_OTHER|||||||0.2799||95.0|||||Welch's t-test|||||||0.2799
91573093|NCT01443403|183034491|SUPERIORITY_OR_OTHER|||||||0.6466||95.0|||||Welch's t-test|||||||0.6466
91573094|NCT01443403|183034493|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Welch's t-test|||||||0.9826
91573095|NCT01443403|183034493|SUPERIORITY_OR_OTHER|||||||0.5188||95.0|||||Welch's t-test|||||||0.5188
91573096|NCT01443403|183034493|SUPERIORITY_OR_OTHER|||||||0.5029||95.0|||||Welch's t-test|||||||0.5029
91573097|NCT03607422|183034526|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|59.6|||<|0.001|TWO_SIDED|95.0|53.1|66.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||66.2|53.1|<0.001
91573098|NCT03607422|183034526|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|46.9|||<|0.001|TWO_SIDED|95.0|39.9|53.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.9|39.9|<0.001
91573099|NCT03607422|183034527|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.4|||<|0.001|TWO_SIDED|95.0|41.0|53.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.7|41.0|<0.001
91573100|NCT03607422|183034527|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.0|||<|0.001|TWO_SIDED|95.0|27.8|40.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.2|27.8|<0.001
91573101|NCT03607422|183034528|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.4|||<|0.001|TWO_SIDED|95.0|43.8|57.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.1|43.8|<0.001
91514162|NCT02347761|182900400|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mean Difference (SE)|0.0961|STANDARD_ERROR_OF_MEAN|0.01896|<|0.0001|TWO_SIDED|95.0|0.0589|0.1334||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|Mixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.|Standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1334|0.0589|<0.0001
91573102|NCT03607422|183034528|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|32.6|||<|0.001|TWO_SIDED|95.0|25.8|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.4|25.8|<0.001
91573103|NCT03607422|183034529|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|46.7|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|46.7|<0.001
91573104|NCT03607422|183034529|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.9|||<|0.001|TWO_SIDED|95.0|30.6|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|30.6|<0.001
91573105|NCT03607422|183034530|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.0|||<|0.001|TWO_SIDED|95.0|50.9|63.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.0|50.9|<0.001
91573106|NCT03607422|183034530|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|38.9|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.4|38.9|<0.001
91573107|NCT03607422|183034531|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.4|||<|0.001|TWO_SIDED|95.0|34.2|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|34.2|<0.001
91573108|NCT03607422|183034531|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.4|||<|0.001|TWO_SIDED|95.0|23.5|35.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||35.3|23.5|<0.001
91573109|NCT03607422|183034532|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|10.6|19.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.3|10.6|<0.001
91573110|NCT03607422|183034532|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|6.7|||<|0.001|TWO_SIDED|95.0|3.4|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.0|3.4|<0.001
91573111|NCT03607422|183034533|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|7.2|||<|0.001|TWO_SIDED|95.0|3.8|10.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.5|3.8|<0.001
91573112|NCT03607422|183034534|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.6|||<|0.001|TWO_SIDED|95.0|4.3|12.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.9|4.3|<0.001
91573113|NCT03607422|183034535|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-23.1|||<|0.001|TWO_SIDED|95.0|-28.4|-17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-17.8|-28.4|<0.001
91573114|NCT03607422|183034535|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-22.4|||<|0.001|TWO_SIDED|95.0|-27.8|-16.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-16.9|-27.8|<0.001
91573115|NCT03607422|183034536|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.8|||<|0.001|TWO_SIDED|95.0|42.2|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|42.2|<0.001
91573116|NCT03607422|183034536|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|30.1|45.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.8|30.1|<0.001
91573117|NCT03607422|183034537|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|51.8|||<|0.001|TWO_SIDED|95.0|44.4|59.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.1|44.4|<0.001
91573118|NCT03607422|183034537|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|28.2|43.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.5|28.2|<0.001
91573119|NCT03607422|183034538|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.0|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|46.0|<0.001
91573120|NCT03607422|183034538|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.7|48.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.0|32.7|<0.001
91573121|NCT03607422|183034539|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|47.2|62.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||62.3|47.2|<0.001
91573122|NCT03607422|183034539|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.3|32.3|<0.001
91573123|NCT03607422|183034540|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|42.8|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||58.5|42.8|<0.001
91573124|NCT03607422|183034540|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.5|46.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.3|29.5|<0.001
91573125|NCT03607422|183034541|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|18.1|||<|0.0001|TWO_SIDED|95.0|13.5|22.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||22.7|13.5|<0.0001
91573126|NCT03607422|183034541|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.4|||<|0.001|TWO_SIDED|95.0|9.2|17.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.6|9.2|<0.001
91573127|NCT03607422|183034542|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-49.45|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|95.0|-56.05|-42.84|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-42.84|-56.05|<0.001
91573128|NCT03607422|183034542|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-34.16|STANDARD_ERROR_OF_MEAN|3.386|<|0.001|TWO_SIDED|95.0|-40.81|-27.51|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.51|-40.81|<0.001
91573129|NCT03607422|183034543|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-50.14|STANDARD_ERROR_OF_MEAN|3.127|<|0.001|TWO_SIDED|95.0|-56.28|-44.0|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-44.00|-56.28|<0.001
91573130|NCT03607422|183034543|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.62|STANDARD_ERROR_OF_MEAN|3.139|<|0.001|TWO_SIDED|95.0|-45.79|-33.46|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.46|-45.79|<0.001
91573131|NCT03607422|183034544|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|47.7|61.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.7|47.7|<0.001
91573132|NCT03607422|183034544|SUPERIORITY||Adjusted Response Rate Difference|42.1|||<|0.001|TWO_SIDED|95.0|34.5|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||49.8|34.5|<0.001
91573133|NCT03607422|183034545|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|41.4|56.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.5|41.4|<0.001
91573134|NCT03607422|183034545|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|42.8||||0.002|TWO_SIDED|95.0|35.0|50.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.6|35.0|0.002
91573135|NCT03607422|183034546|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.949|<|0.001|TWO_SIDED|95.0|-45.8|-34.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.22|-45.80|<0.001
91573136|NCT03607422|183034546|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-29.47|STANDARD_ERROR_OF_MEAN|2.941|<|0.001|TWO_SIDED|95.0|-35.24|-23.69|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.||||-23.69|-35.24|<0.001
91573137|NCT03607422|183034547|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|44.5|||<|0.001|TWO_SIDED|95.0|35.0|54.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.1|35.0|<0.001
91573138|NCT03607422|183034547|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.4|||<|0.001|TWO_SIDED|95.0|24.7|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.2|24.7|<0.001
91573139|NCT03607422|183034548|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|33.3|||<|0.001|TWO_SIDED|95.0|26.9|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.8|26.9|<0.001
91573140|NCT03607422|183034548|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|19.1|||<|0.001|TWO_SIDED|95.0|13.3|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||24.9|13.3|<0.001
91573141|NCT03607422|183034549|SUPERIORITY||Adjusted Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|45.9|73.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||73.8|45.9|<0.001
91573142|NCT03607422|183034549|SUPERIORITY||Adjusted Response Rate Difference|55.8|||<|0.001|TWO_SIDED|95.0|41.1|70.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.4|41.1|<0.001
91573143|NCT03607422|183034550|SUPERIORITY||Adjusted Response Rate Difference|53.9|||<|0.001|TWO_SIDED|95.0|40.6|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.3|40.6|<0.001
91573144|NCT03607422|183034550|SUPERIORITY||Adjusted Response Rate Difference|39.4|||<|0.001|TWO_SIDED|95.0|25.7|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|25.7|<0.001
91573145|NCT03607422|183034551|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|40.0|66.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.1|40.0|<0.001
91573146|NCT03607422|183034551|SUPERIORITY||Adjusted Response Rate Difference|35.0|||<|0.001|TWO_SIDED|95.0|21.8|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|21.8|<0.001
91573147|NCT03607422|183034552|SUPERIORITY||Adjusted Response Rate Difference|60.2|||<|0.001|TWO_SIDED|95.0|47.5|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|47.5|<0.001
91573148|NCT03607422|183034552|SUPERIORITY||Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|33.4|59.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.9|33.4|<0.001
91573149|NCT03607422|183034553|SUPERIORITY||Adjusted Response Rate Difference|46.4|||<|0.001|TWO_SIDED|95.0|33.2|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.6|33.2|<0.001
91573150|NCT03607422|183034553|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|21.4|48.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.4|21.4|<0.001
91573151|NCT03607422|183034554|SUPERIORITY||Adjusted Response Rate Difference|46.2|||<|0.001|TWO_SIDED|95.0|32.4|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.0|32.4|<0.001
91573152|NCT03607422|183034554|SUPERIORITY||Adjusted Response Rate Difference|31.3|||<|0.001|TWO_SIDED|95.0|17.3|45.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.3|17.3|<0.001
91573153|NCT03607422|183034555|SUPERIORITY||Adjusted Response Rate Difference|5.0||||0.075|TWO_SIDED|95.0|-0.5|10.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||10.6|-0.5|0.075
91573154|NCT03607422|183034555|SUPERIORITY||Adjusted Response Rate Difference|12.7||||0.005|TWO_SIDED|95.0|3.9|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|3.9|0.005
91573155|NCT03607422|183034556|SUPERIORITY||Adjusted Response Rate Difference|3.2||||0.151|TWO_SIDED|95.0|-1.2|7.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||7.6|-1.2|0.151
91573156|NCT03607422|183034557|SUPERIORITY||Adjusted Response Rate Difference|12.9||||0.008|TWO_SIDED|95.0|3.4|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||22.3|3.4|0.008
91573157|NCT03607422|183034558|SUPERIORITY||Adjusted Response Rate Difference|-18.0|||<|0.001|TWO_SIDED|95.0|-28.0|-8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-8.0|-28.0|<0.001
91573158|NCT03607422|183034558|SUPERIORITY||Adjusted Response Rate Difference|-17.9||||0.001|TWO_SIDED|95.0|-28.1|-7.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-7.7|-28.1|0.001
91573159|NCT03607422|183034559|SUPERIORITY||Adjusted Response Rate Difference|51.5|||<|0.001|TWO_SIDED|95.0|34.8|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.3|34.8|<0.001
91573160|NCT03607422|183034559|SUPERIORITY||Adjusted Response Rate Difference|29.2||||0.001|TWO_SIDED|95.0|11.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.6|11.8|0.001
91573161|NCT03607422|183034560|SUPERIORITY||Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|38.4|68.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.0|38.4|<0.001
91573162|NCT03607422|183034560|SUPERIORITY||Adjusted Response Rate Difference|31.8|||<|0.001|TWO_SIDED|95.0|16.5|47.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||47.1|16.5|<0.001
91573163|NCT03607422|183034561|SUPERIORITY||Adjusted Response Rate Difference|48.9|||<|0.001|TWO_SIDED|95.0|33.8|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.1|33.8|<0.001
91573164|NCT03607422|183034561|SUPERIORITY||Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|21.1|53.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.6|21.1|<0.001
91573165|NCT03607422|183034562|SUPERIORITY||Adjusted Response Rate Difference|53.8|||<|0.001|TWO_SIDED|95.0|37.4|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|37.4|<0.001
91573166|NCT03607422|183034562|SUPERIORITY||Adjusted Response Rate Difference|42.0|||<|0.001|TWO_SIDED|95.0|24.3|59.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.7|24.3|<0.001
91573167|NCT03607422|183034563|SUPERIORITY||Adjusted Response Rate Difference|45.3|||<|0.001|TWO_SIDED|95.0|28.0|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.7|28.0|<0.001
91573168|NCT03607422|183034563|SUPERIORITY||Adjusted Response Rate Difference|29.8||||0.002|TWO_SIDED|95.0|10.7|48.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.8|10.7|0.002
91573169|NCT03607422|183034564|SUPERIORITY||Adjusted Response Rate Difference|17.1|||<|0.001|TWO_SIDED|95.0|7.5|26.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||26.7|7.5|<0.001
91573170|NCT03607422|183034564|SUPERIORITY||Adjusted Response Rate Difference|13.7||||0.006|TWO_SIDED|95.0|3.9|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.5|3.9|0.006
91573171|NCT03607422|183034565|SUPERIORITY||LS Mean Difference|-55.93|STANDARD_ERROR_OF_MEAN|7.284|<|0.001|TWO_SIDED|95.0|-70.32|-41.55|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-41.55|-70.32|<0.001
91573172|NCT03607422|183034565|SUPERIORITY||LS Mean Difference|-36.54|STANDARD_ERROR_OF_MEAN|7.384|<|0.001|TWO_SIDED|95.0|-51.12|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-21.96|-51.12|<0.001
91573173|NCT03607422|183034566|SUPERIORITY||LS Mean Difference|-42.62|STANDARD_ERROR_OF_MEAN|6.432|<|0.001|TWO_SIDED|95.0|-55.34|-29.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-29.90|-55.34|<0.001
91573174|NCT03607422|183034566|SUPERIORITY||LS Mean Difference|-35.66|STANDARD_ERROR_OF_MEAN|6.447|<|0.001|TWO_SIDED|95.0|-48.41|-22.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-22.90|-48.41|<0.001
91573175|NCT03607422|183034567|SUPERIORITY||Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|36.9|68.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.1|36.9|<0.001
91573176|NCT03607422|183034567|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|21.2|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||54.9|21.2|<0.001
91573177|NCT03607422|183034568|SUPERIORITY||Adjusted Response Rate Difference|55.9|||<|0.001|TWO_SIDED|95.0|35.5|76.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||76.3|35.5|<0.001
91573178|NCT03607422|183034568|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.3|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|26.3|<0.001
91573179|NCT03607422|183034569|SUPERIORITY||LS Mean Difference|-44.9|STANDARD_ERROR_OF_MEAN|6.492|<|0.001|TWO_SIDED|95.0|-57.74|-32.06|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-32.06|-57.74|<0.001
91573180|NCT03607422|183034569|SUPERIORITY||LS Mean Difference|-29.98|STANDARD_ERROR_OF_MEAN|6.383|<|0.001|TWO_SIDED|95.0|-42.6|-17.36|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-17.36|-42.60|<0.001
91573181|NCT03607422|183034570|SUPERIORITY||Adjusted Response Rate Difference|27.8||||0.016|TWO_SIDED|95.0|5.2|50.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||50.4|5.2|0.016
91573182|NCT03607422|183034570|SUPERIORITY||Adjusted Response Rate Difference|22.3||||0.062|TWO_SIDED|95.0|-1.1|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.7|-1.1|0.062
91573183|NCT03607422|183034571|SUPERIORITY||Adjusted Response Rate Difference|38.9|||<|0.001|TWO_SIDED|95.0|18.4|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.4|18.4|<0.001
91573184|NCT03607422|183034571|SUPERIORITY||Adjusted Response Rate Difference|5.9||||0.51|TWO_SIDED|95.0|-11.7|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.6|-11.7|0.510
91573185|NCT03258723|183034583|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
91573186|NCT03258723|183034584|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0005
91573187|NCT03258723|183034585|SUPERIORITY|||||||0.1809|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.1809
91573188|NCT03258723|183034586|SUPERIORITY|||||||0.0973|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0973
91573189|NCT03258723|183034588|SUPERIORITY|||||||0.1992|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.1992
91573190|NCT03258723|183034589|SUPERIORITY|||||||0.7017|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.7017
91573191|NCT03258723|183034590|SUPERIORITY|||||||0.1573|||||||McNemar|||Within group change from baseline assessed on matched cases in low activity group at baseline.||||0.1573
91573192|NCT03258723|183034590|SUPERIORITY|||||||0.4328|||||||McNemar|||Within group change from baseline assessed on matched cases in medium activity group at baseline.||||0.4328
91573193|NCT03258723|183034590|SUPERIORITY|||||||0.6698|||||||McNemar|||Within group change from baseline assessed on matched cases in high activity group at baseline.||||0.6698
91573194|NCT03258723|183034591|SUPERIORITY|||||||0.5271|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.5271
91573195|NCT03258723|183034592|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
91573196|NCT04832971|183034593|SUPERIORITY||Difference vs. Placebo at Week 24|-51.22|||<|0.0001|TWO_SIDED|95.0|-61.73|-40.7||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-40.70|-61.73|<.0001
91573197|NCT04832971|183034593|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
91573198|NCT04832971|183034593|SUPERIORITY||Difference vs Placebo at Week 24|-56.56|||<|0.0001|TWO_SIDED|95.0|-67.09|-46.04||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-46.04|-67.09|<.0001
91573199|NCT04832971|183034593|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
91573200|NCT04832971|183034593|SUPERIORITY||Difference vs. Placebo at Week 24|-63.11|||<|0.0001|TWO_SIDED|95.0|-73.56|-52.66||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model with Repeated Measures|||||-52.66|-73.56|<.0001
91573201|NCT04832971|183034593|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
91573202|NCT04832971|183034594|SUPERIORITY||Difference|-48.52|||<|0.0001|TWO_SIDED|95.0|-58.53|-38.51||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-38.51|-58.53|<.0001
91573203|NCT04832971|183034594|SUPERIORITY||Difference|-59.21|||<|0.0001|TWO_SIDED|95.0|-69.3|-49.12||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-49.12|-69.30|<.0001
91573204|NCT04832971|183034594|SUPERIORITY||Difference|-63.21|||<|0.0001|TWO_SIDED|95.0|-73.24|-53.18||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-53.18|-73.24|<.0001
91573205|NCT04832971|183034594|SUPERIORITY||Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-66.31|-42.89||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|m|||Week 8||-42.89|-66.31|<.0001
91573206|NCT04832971|183034594|SUPERIORITY||Difference|-61.31|||<|0.0001|TWO_SIDED|95.0|-73.07|-49.55||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-49.55|-73.07|<.0001
91573207|NCT04832971|183034594|SUPERIORITY||Difference|-66.13|||<|0.0001|TWO_SIDED|95.0|-77.9|-54.37||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-54.37|-77.90|<.0001
91573208|NCT04832971|183034594|SUPERIORITY||Difference|-44.96|||<|0.0001|TWO_SIDED|95.0|-56.91|-33.01||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-33.01|-56.91|<.0001
91573209|NCT04832971|183034594|SUPERIORITY||Difference|-43.87|||<|0.0001|TWO_SIDED|95.0|-55.83|-31.92||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-31.92|-55.83|<.0001
91573210|NCT04832971|183034594|SUPERIORITY||Difference|-52.0|||<|0.0001|TWO_SIDED|95.0|-63.83|-40.18||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-40.18|-63.83|<.0001
91573211|NCT04832971|183034594|SUPERIORITY||Difference|-65.66|||<|0.0001|TWO_SIDED|95.0|-85.04|-46.29||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-46.29|-85.04|<.0001
91573212|NCT04832971|183034594|SUPERIORITY||Difference|-69.17|||<|0.0001|TWO_SIDED|95.0|-88.54|-49.8||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-49.80|-88.54|<.0001
91573213|NCT04832971|183034594|SUPERIORITY||Difference|-75.91|||<|0.0001|TWO_SIDED|95.0|-95.11|-56.71||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-56.71|-95.11|<.0001
91573214|NCT04832971|183034594|SUPERIORITY||Difference|-60.24|||<|0.0001|TWO_SIDED|95.0|-76.78|-43.71||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-43.71|-76.78|<.0001
91573215|NCT04832971|183034594|SUPERIORITY||Difference|-64.27|||<|0.0001|TWO_SIDED|95.0|-80.83|-47.72||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-47.72|-80.83|<.0001
91573216|NCT04832971|183034594|SUPERIORITY||Difference|-69.52|||<|0.0001|TWO_SIDED|95.0|-85.85|-53.18||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-53.18|-85.85|<.0001
91573217|NCT04832971|183034594|SUPERIORITY||Difference|-51.22|||<|0.0001|TWO_SIDED|95.0|-61.73|-40.7||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-40.70|-61.73|<.0001
91573218|NCT04832971|183034594|SUPERIORITY||Difference|-56.56|||<|0.0001|TWO_SIDED|95.0|-67.09|-46.04||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-46.04|-67.09|<.0001
91573219|NCT04832971|183034594|SUPERIORITY||Difference|-63.11|||<|0.0001|TWO_SIDED|95.0|-73.56|-52.66||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-52.66|-73.56|<.0001
91573220|NCT04832971|183034594|SUPERIORITY||Difference|-48.62|||<|0.0001|TWO_SIDED|95.0|-59.66|-37.59||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-37.59|-59.66|<.0001
91573221|NCT04832971|183034594|SUPERIORITY||Difference|-51.19|||<|0.0001|TWO_SIDED|95.0|-62.32|-40.05||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-40.05|-62.32|<.0001
91573222|NCT04832971|183034594|SUPERIORITY||Difference|-61.63|||<|0.0001|TWO_SIDED|95.0|-72.6|-50.67||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-50.67|-72.60|<.0001
91573223|NCT04832971|183034594|SUPERIORITY||Difference|-34.06|||<|0.0001|TWO_SIDED|95.0|-44.65|-23.46||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-23.46|-44.65|<.0001
91573224|NCT04832971|183034594|SUPERIORITY||Difference|-37.9|||<|0.0001|TWO_SIDED|95.0|-48.56|-27.25||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-27.25|-48.56|<.0001
91573225|NCT04832971|183034594|SUPERIORITY||Difference|-51.19|||<|0.0001|TWO_SIDED|95.0|-61.71|-40.68||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-40.68|-61.71|<.0001
91573226|NCT04832971|183034595|SUPERIORITY||Difference vs. Placebo at Week 24|-29.2|||<|0.0001|TWO_SIDED|95.0|-38.5|-20.0||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-20.0|-38.5|<.0001
91573227|NCT04832971|183034595|SUPERIORITY||Difference vs. Placebo at Week 24|-28.7|||<|0.0001|TWO_SIDED|95.0|-37.9|-19.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-19.5|-37.9|<.0001
91573228|NCT04832971|183034595|SUPERIORITY||Difference vs. Placebo at Week 24|-36.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-27.2||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-27.2|-45.5|<.0001
91573229|NCT04832971|183034596|SUPERIORITY||Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.7|-21.7||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-21.7|-35.7|<.0001
91573230|NCT04832971|183034596|SUPERIORITY||Difference|-30.5|||<|0.0001|TWO_SIDED|95.0|-37.5|-23.4||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-23.4|-37.5|<.0001
91573231|NCT04832971|183034596|SUPERIORITY||Difference|-38.1|||<|0.0001|TWO_SIDED|95.0|-45.1|-31.2||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-31.2|-45.1|<.0001
91573232|NCT04832971|183034596|SUPERIORITY||Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-36.6|-19.7||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-19.7|-36.6|<.0001
91573233|NCT04832971|183034596|SUPERIORITY||Difference|-26.6|||<|0.0001|TWO_SIDED|95.0|-35.0|-18.1||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-18.1|-35.0|<.0001
91573234|NCT04832971|183034596|SUPERIORITY||Difference|-34.0|||<|0.0001|TWO_SIDED|95.0|-42.4|-25.6||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-25.6|-42.4|<.0001
91573235|NCT04832971|183034596|SUPERIORITY||Difference|-26.1|||<|0.0001|TWO_SIDED|95.0|-34.6|-17.6||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-17.6|-34.6|<.0001
91573236|NCT04832971|183034596|SUPERIORITY||Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-30.3|-13.3||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-13.3|-30.3|<.0001
91573237|NCT04832971|183034596|SUPERIORITY||Difference|-31.5|||<|0.0001|TWO_SIDED|95.0|-39.9|-23.1||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-23.1|-39.9|<.0001
91573238|NCT04832971|183034596|SUPERIORITY||Difference|-29.3|||<|0.0001|TWO_SIDED|95.0|-37.3|-21.4||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-21.4|-37.3|<.0001
91573239|NCT04832971|183034596|SUPERIORITY||Difference|-30.8|||<|0.0001|TWO_SIDED|95.0|-38.8|-22.9||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-22.9|-38.8|<.0001
91573240|NCT04832971|183034596|OTHER||Difference|-39.5|||<|0.0001|TWO_SIDED|95.0|-47.4|-31.6||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-31.6|-47.4|<.0001
91573241|NCT04832971|183034596|SUPERIORITY||Difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-36.4|-21.4||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-21.4|-36.4|<.0001
91573242|NCT04832971|183034596|SUPERIORITY||Difference|-27.2|||<|0.0001|TWO_SIDED|95.0|-34.8|-19.7||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-19.7|-34.8|<.0001
91573243|NCT04832971|183034596|SUPERIORITY||Difference|-34.8|||<|0.0001|TWO_SIDED|95.0|-42.3|-27.4||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-27.4|-42.3|<.0001
91573244|NCT04832971|183034596|SUPERIORITY||Difference|-29.2|||<|0.0001|TWO_SIDED|95.0|-38.5|-20.0||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-20.0|-38.5|<.0001
91573245|NCT04832971|183034596|SUPERIORITY||Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-37.9|-19.5||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-19.5|-37.9|<.0001
91573246|NCT04832971|183034596|SUPERIORITY||Difference|-36.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-27.2||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-27.2|-45.5|<.0001
91573247|NCT04832971|183034596|SUPERIORITY||Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-32.7|-15.9||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-15.9|-32.7|<.0001
91573248|NCT04832971|183034596|SUPERIORITY||Difference|-23.5|||<|0.0001|TWO_SIDED|95.0|-31.9|-15.1||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-15.1|-31.9|<.0001
91573249|NCT04832971|183034596|SUPERIORITY||Difference|-31.2|||<|0.0001|TWO_SIDED|95.0|-39.5|-22.9||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-22.9|-39.5|<.0001
91573250|NCT04832971|183034596|SUPERIORITY||Difference|-18.6|||<|0.0001|TWO_SIDED|95.0|-27.6|-9.7||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-9.7|-27.6|<.0001
91573251|NCT04832971|183034596|SUPERIORITY||Difference|-15.8||||0.0006|TWO_SIDED|95.0|-24.7|-6.8||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-6.8|-24.7|0.0006
91573252|NCT04832971|183034596|SUPERIORITY||Difference|-22.6|||<|0.0001|TWO_SIDED|95.0|-31.4|-13.8||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-13.8|-31.4|<.0001
91573253|NCT04832971|183034597|SUPERIORITY||Difference vs. Placebo at Week 24|-18.66|||<|0.0001|TWO_SIDED|95.0|-26.53|-10.8||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-10.80|-26.53|<.0001
91573254|NCT04832971|183034597|SUPERIORITY||Difference vs. Placebo at Week 24|-15.18||||0.0002|TWO_SIDED|95.0|-23.0|-7.36||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-7.36|-23.00|0.0002
91573255|NCT04832971|183034597|SUPERIORITY||Difference vs. Placebo at Week 24|-21.9|||<|0.0001|TWO_SIDED|95.0|-29.69|-14.12||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-14.12|-29.69|<.0001
91573256|NCT04832971|183034598|SUPERIORITY||Difference|-16.57|||<|0.0001|TWO_SIDED|95.0|-22.41|-10.74||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-10.74|-22.41|<.0001
91573257|NCT04832971|183034598|SUPERIORITY||Difference|-14.28|||<|0.0001|TWO_SIDED|95.0|-20.08|-8.48||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-8.48|-20.08|<.0001
91573258|NCT04832971|183034598|SUPERIORITY||Difference|-21.04|||<|0.0001|TWO_SIDED|95.0|-26.85|-15.23||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-15.23|-26.85|<.0001
91573259|NCT04832971|183034598|SUPERIORITY||Difference|-17.35|||<|0.0001|TWO_SIDED|95.0|-24.42|-10.29||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-10.29|-24.42|<.0001
91573260|NCT04832971|183034598|SUPERIORITY||Difference|-12.16||||0.0008|TWO_SIDED|95.0|-19.19|-5.13||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-5.13|-19.19|0.0008
91573261|NCT04832971|183034598|SUPERIORITY||Difference|-16.56|||<|0.0001|TWO_SIDED|95.0|-23.62|-9.5||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-9.50|-23.62|<.0001
91573262|NCT04832971|183034598|SUPERIORITY||Difference|-17.21|||<|0.0001|TWO_SIDED|95.0|-24.61|-9.81||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-9.81|-24.61|<.0001
91573263|NCT04832971|183034598|SUPERIORITY||Difference|-9.95||||0.0082|TWO_SIDED|95.0|-17.3|-2.6||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-2.60|-17.30|0.0082
91573264|NCT04832971|183034598|SUPERIORITY||Difference|-17.35|||<|0.0001|TWO_SIDED|95.0|-24.68|-10.03||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-10.03|-24.68|<.0001
91573265|NCT04832971|183034598|SUPERIORITY||Difference|-14.36|||<|0.0001|TWO_SIDED|95.0|-21.42|-7.3||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-7.30|-21.42|<.0001
91573266|NCT04832971|183034598|SUPERIORITY||Difference|-12.97||||0.0003|TWO_SIDED|95.0|-19.98|-5.95||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-5.95|-19.98|0.0003
91573267|NCT04832971|183034598|OTHER||Difference|-20.3|||<|0.0001|TWO_SIDED|95.0|-27.3|-13.29||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-13.29|-27.30|<.0001
91573268|NCT04832971|183034598|SUPERIORITY||Difference|-17.71|||<|0.0001|TWO_SIDED|95.0|-24.29|-11.13||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-11.13|-24.29|<.0001
91573269|NCT04832971|183034598|SUPERIORITY||Difference|-14.23|||<|0.0001|TWO_SIDED|95.0|-20.75|-7.72||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-7.72|-20.75|<.0001
91573270|NCT04832971|183034598|SUPERIORITY||Difference|-18.3|||<|0.0001|TWO_SIDED|95.0|-24.8|-11.79||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-11.79|-24.80|<.0001
91573271|NCT04832971|183034598|SUPERIORITY||Difference|-18.66|||<|0.0001|TWO_SIDED|95.0|-26.53|-10.8||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-10.80|-26.53|<.0001
91573272|NCT04832971|183034598|SUPERIORITY||Difference|-15.18||||0.0002|TWO_SIDED|95.0|-23.0|-7.36||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-7.36|-23.00|0.0002
91573273|NCT04832971|183034598|SUPERIORITY||Difference|-21.9|||<|0.0001|TWO_SIDED|95.0|-29.69|-14.12||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-14.12|-29.69|<.0001
91573274|NCT04832971|183034598|SUPERIORITY||Difference|-15.9|||<|0.0001|TWO_SIDED|95.0|-23.44|-8.35||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-8.35|-23.44|<.0001
91573275|NCT04832971|183034598|SUPERIORITY||Difference|-12.98||||0.0008|TWO_SIDED|95.0|-20.49|-5.46||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-5.46|-20.49|0.0008
91573276|NCT04832971|183034598|SUPERIORITY||Difference|-17.54|||<|0.0001|TWO_SIDED|95.0|-25.01|-10.07||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-10.07|-25.01|<.0001
91573277|NCT04832971|183034598|SUPERIORITY||Difference|-10.55||||0.0081|TWO_SIDED|95.0|-18.32|-2.77||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-2.77|-18.32|0.0081
91573278|NCT04832971|183034598|SUPERIORITY||Difference|-6.76||||0.0871|TWO_SIDED|95.0|-14.52|0.99||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||0.99|-14.52|0.0871
91573279|NCT04832971|183034598|SUPERIORITY||Difference|-10.91||||0.0058|TWO_SIDED|95.0|-18.61|-3.2||MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-3.20|-18.61|0.0058
91573280|NCT04832971|183034599|SUPERIORITY||Difference vs. Placebo at Week 24|-16.0||||0.0138|TWO_SIDED|95.0|-28.7|-3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.3|-28.7|0.0138
91573281|NCT04832971|183034599|SUPERIORITY||Difference vs Placebo at Week 24|-9.3||||0.148|TWO_SIDED|95.0|-22.0|3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repated Measures|||||3.3|-22.0|0.1480
91573282|NCT04832971|183034599|SUPERIORITY||Difference vs Placebo at Week 24|-20.2||||0.0019|TWO_SIDED|95.0|-32.8|-7.5||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mxed Models Repeated Measures|||||-7.5|-32.8|0.0019
91573283|NCT04832971|183034600|SUPERIORITY||Difference|-13.3||||0.0192|TWO_SIDED|95.0|-24.5|-2.2||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-2.2|-24.5|0.0192
91573284|NCT04832971|183034600|SUPERIORITY||Difference|-8.4||||0.1362|TWO_SIDED|95.0|-19.6|2.7||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||2.7|-19.6|0.1362
91573285|NCT04832971|183034600|SUPERIORITY||Difference|-18.7||||0.001|TWO_SIDED|95.0|-29.8|-7.7||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-7.7|-29.8|0.0010
91573286|NCT04832971|183034600|SUPERIORITY||Difference|-13.9||||0.0428|TWO_SIDED|95.0|-27.3|-0.5||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-0.5|-27.3|0.0428
91573287|NCT04832971|183034600|SUPERIORITY||Difference|-4.5||||0.5122|TWO_SIDED|95.0|-17.9|8.9||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||8.9|-17.9|0.5122
91573288|NCT04832971|183034600|SUPERIORITY||Difference|-14.6||||0.0331|TWO_SIDED|95.0|-27.9|-1.2||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-1.2|-27.9|0.0331
91573289|NCT04832971|183034600|SUPERIORITY||Difference|-15.4||||0.14|TWO_SIDED|95.0|-35.8|5.1||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||5.1|-35.8|0.1400
91573290|NCT04832971|183034600|SUPERIORITY||Difference|0.2||||0.9854|TWO_SIDED|95.0|-20.2|20.6||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||20.6|-20.2|0.9854
91573291|NCT04832971|183034600|SUPERIORITY||Difference|-19.8||||0.0552|TWO_SIDED|95.0|-40.1|0.4||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||0.4|-40.1|0.0552
91573292|NCT04832971|183034600|SUPERIORITY||Difference|-13.1||||0.043|TWO_SIDED|95.0|-25.7|-0.4||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-0.4|-25.7|0.0430
91573293|NCT04832971|183034600|SUPERIORITY||Difference|-11.0||||0.0871|TWO_SIDED|95.0|-23.6|1.6||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||1.6|-23.6|0.0871
91573294|NCT04832971|183034600|SUPERIORITY||Difference|-23.1||||0.0004|TWO_SIDED|95.0|-35.7|-10.6||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-10.6|-35.7|0.0004
91573295|NCT04832971|183034600|SUPERIORITY||Difference|-14.0||||0.0219|TWO_SIDED|95.0|-25.9|-2.0||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-2.0|-25.9|0.0219
91573296|NCT04832971|183034600|SUPERIORITY||Difference|-8.7||||0.1526|TWO_SIDED|95.0|-20.6|3.2||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||3.2|-20.6|0.1526
91573297|NCT04832971|183034600|SUPERIORITY||Difference|-17.0||||0.0049|TWO_SIDED|95.0|-28.9|-5.2||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-5.2|-28.9|0.0049
91573298|NCT04832971|183034600|SUPERIORITY||Difference|-16.0||||0.0138|TWO_SIDED|95.0|-28.7|-3.3||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-3.3|-28.7|0.0138
91573299|NCT04832971|183034600|SUPERIORITY||Difference|-9.3||||0.148|TWO_SIDED|95.0|-22.0|3.3||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||3.3|-22.0|0.1480
91573300|NCT04832971|183034600|SUPERIORITY||Difference|-20.2||||0.0019|TWO_SIDED|95.0|-32.8|-7.5||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-7.5|-32.8|0.0019
91573301|NCT04832971|183034600|SUPERIORITY||Difference|-9.3||||0.166|TWO_SIDED|95.0|-22.4|3.9||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||3.9|-22.4|0.1660
91573302|NCT04832971|183034600|SUPERIORITY||Difference|-2.6||||0.6964|TWO_SIDED|95.0|-15.7|10.5||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||10.5|-15.7|0.6964
91573303|NCT04832971|183034600|SUPERIORITY||Difference|-11.5||||0.0831|TWO_SIDED|95.0|-24.5|1.5||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||1.5|-24.5|0.0831
91573304|NCT04832971|183034600|SUPERIORITY||Difference|-12.0||||0.1425|TWO_SIDED|95.0|-28.2|4.1||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||4.1|-28.2|0.1425
91573305|NCT04832971|183034600|SUPERIORITY||Difference|0.5||||0.9494|TWO_SIDED|95.0|-15.6|16.6||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||16.6|-15.6|0.9494
91573306|NCT04832971|183034600|SUPERIORITY||Difference|-7.5||||0.3535|TWO_SIDED|95.0|-23.5|8.4||MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||8.4|-23.5|0.3535
91573307|NCT04832971|183034601|SUPERIORITY||Difference vs Placebo|-54.26|||<|0.0001|TWO_SIDED|95.0|-62.11|-46.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|mixed Models Repeated Measures|||||-46.40|-62.11|<.0001
91573308|NCT04832971|183034601|SUPERIORITY||Difference vs Placebo at Week 24|-69.76|||<|0.0001|TWO_SIDED|95.0|-77.58|-61.95||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-61.95|-77.58|<.0001
91573309|NCT04832971|183034601|SUPERIORITY||Difference vs Placebo at Week 24|-73.69|||<|0.0001|TWO_SIDED|95.0|-81.44|-65.93||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-65.93|-81.44|<.0001
91573310|NCT04832971|183034602|SUPERIORITY||Difference|-67.65|||<|0.0001|TWO_SIDED|95.0|-74.26|-61.04||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-61.04|-74.26|<.0001
91573311|NCT04832971|183034602|SUPERIORITY||Difference|-80.8|||<|0.0001|TWO_SIDED|95.0|-87.42|-74.17||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-74.17|-87.42|<.0001
91573312|NCT04832971|183034602|SUPERIORITY||Difference|-84.69|||<|0.0001|TWO_SIDED|95.0|-91.27|-78.12||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-78.12|-91.27|<.0001
91573313|NCT04832971|183034602|SUPERIORITY||Difference|-59.07|||<|0.0001|TWO_SIDED|95.0|-67.57|-50.57||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-50.57|-67.57|<.0001
91573314|NCT04832971|183034602|SUPERIORITY||Difference|-71.98|||<|0.0001|TWO_SIDED|95.0|-80.47|-63.5||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-63.50|-80.47|<.0001
91573315|NCT04832971|183034602|SUPERIORITY||Difference|-76.44|||<|0.0001|TWO_SIDED|95.0|-84.9|-67.99||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-67.99|-84.90|<.0001
91573316|NCT04832971|183034602|SUPERIORITY||Difference|-55.1|||<|0.0001|TWO_SIDED|95.0|-65.18|-45.01||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-45.01|-65.18|<.0001
91573317|NCT04832971|183034602|SUPERIORITY||Difference|-70.55|||<|0.0001|TWO_SIDED|95.0|-80.6|-60.51||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-60.51|-80.60|<.0001
91573318|NCT04832971|183034602|SUPERIORITY||Difference|-74.0|||<|0.0001|TWO_SIDED|95.0|-83.95|-64.04||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-64.04|-83.95|<.0001
91573319|NCT04832971|183034602|SUPERIORITY||Difference|-72.22|||<|0.0001|TWO_SIDED|95.0|-78.88|-65.56||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-65.56|-78.88|<.0001
91573320|NCT04832971|183034602|SUPERIORITY||Difference|-84.09|||<|0.0001|TWO_SIDED|95.0|-90.72|-77.46||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-77.46|-90.72|<.0001
91573321|NCT04832971|183034602|SUPERIORITY||Difference|-89.0|||<|0.0001|TWO_SIDED|95.0|-95.59|-82.42||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-82.42|-95.59|<.0001
91573322|NCT04832971|183034602|SUPERIORITY||Difference|-64.86|||<|0.0001|TWO_SIDED|95.0|-71.4|-58.31||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-58.31|-71.40|<.0001
91573323|NCT04832971|183034602|SUPERIORITY||Difference|-77.45|||<|0.0001|TWO_SIDED|95.0|-83.98|-70.93||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-70.93|-83.98|<.0001
91573324|NCT04832971|183034602|SUPERIORITY||Difference|-80.6|||<|0.0001|TWO_SIDED|95.0|-87.06|-74.14||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-74.14|-87.06|<.0001
91573325|NCT04832971|183034602|SUPERIORITY||Difference|-54.26|||<|0.0001|TWO_SIDED|95.0|-62.11|-46.4||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-46.40|-62.11|<.0001
91573326|NCT04832971|183034602|SUPERIORITY||Difference|-69.76|||<|0.0001|TWO_SIDED|95.0|-77.58|-61.95||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-61.95|-77.58|<.0001
91573327|NCT04832971|183034602|SUPERIORITY||Difference|-73.69|||<|0.0001|TWO_SIDED|95.0|-81.44|-65.93||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-65.93|-81.44|<.0001
91573328|NCT04832971|183034602|SUPERIORITY||Difference|-54.75|||<|0.0001|TWO_SIDED|95.0|-62.84|-46.67||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-46.67|-62.84|<.0001
91573329|NCT04832971|183034602|SUPERIORITY||Difference|-66.6|||<|0.0001|TWO_SIDED|95.0|-74.69|-58.52||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-58.52|-74.69|<.0001
91573330|NCT04832971|183034602|SUPERIORITY||Difference|-73.37|||<|0.0001|TWO_SIDED|95.0|-81.36|-65.38||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-65.38|-81.36|<.0001
91573331|NCT04832971|183034602|SUPERIORITY||Difference|-45.43|||<|0.0001|TWO_SIDED|95.0|-54.17|-36.69||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-36.69|-54.17|<.0001
91573332|NCT04832971|183034602|SUPERIORITY||Difference|-57.15|||<|0.0001|TWO_SIDED|95.0|-65.88|-48.41||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-48.41|-65.88|<.0001
91573333|NCT04832971|183034602|SUPERIORITY||Difference|-63.58|||<|0.0001|TWO_SIDED|95.0|-72.19|-54.97||Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-54.97|-72.19|<.0001
91573334|NCT04832971|183034603|SUPERIORITY||Difference vs Placebo at Week 24|-12.0||||0.0039|TWO_SIDED|95.0|-20.2|-3.9||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.9|-20.2|0.0039
91573335|NCT04832971|183034603|SUPERIORITY||Difference vs Placebo at Week 24|-21.6|||<|0.0001|TWO_SIDED|95.0|-29.8|-13.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-13.4|-29.8|<.0001
91573336|NCT04832971|183034603|SUPERIORITY||Differeence vs Placebo at week 24|-24.5|||<|0.0001|TWO_SIDED|95.0|-32.6|-16.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-16.5|-32.6|<.0001
91573337|NCT04832971|183034604|SUPERIORITY||Difference|-13.7||||0.0003|TWO_SIDED|95.0|-20.9|-6.4||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-6.4|-20.9|0.0003
91573338|NCT04832971|183034604|SUPERIORITY||Difference|-25.3|||<|0.0001|TWO_SIDED|95.0|-32.6|-17.9||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-17.9|-32.6|<.0001
91573339|NCT04832971|183034604|SUPERIORITY||Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-31.8|-17.3||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 4||-17.3|-31.8|<.0001
91573340|NCT04832971|183034604|SUPERIORITY||Difference|-15.0||||0.0001|TWO_SIDED|95.0|-22.4|-7.5||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-7.5|-22.4|0.0001
91573341|NCT04832971|183034604|SUPERIORITY||Difference|-25.4|||<|0.0001|TWO_SIDED|95.0|-33.0|-17.9||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-17.9|-33.0|<.0001
91573342|NCT04832971|183034604|SUPERIORITY||Difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-33.7|-18.7||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 8||-18.7|-33.7|<.0001
91573343|NCT04832971|183034604|SUPERIORITY||Difference|-8.9||||0.0429|TWO_SIDED|95.0|-17.6|-0.3||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-0.3|-17.6|0.0429
91573344|NCT04832971|183034604|SUPERIORITY||Difference|-20.7|||<|0.0001|TWO_SIDED|95.0|-29.4|-12.0||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-12.0|-29.4|<.0001
91573345|NCT04832971|183034604|SUPERIORITY||Difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-28.7|-11.6||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 12||-11.6|-28.7|<.0001
91573346|NCT04832971|183034604|SUPERIORITY||Difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-26.2|-9.5||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-9.5|-26.2|<.0001
91573347|NCT04832971|183034604|SUPERIORITY||Difference|-30.6|||<|0.0001|TWO_SIDED|95.0|-39.0|-22.2||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-22.2|-39.0|<.0001
91573348|NCT04832971|183034604|SUPERIORITY||Difference|-32.3|||<|0.0001|TWO_SIDED|95.0|-40.5|-24.0||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 16||-24.0|-40.5|<.0001
91573349|NCT04832971|183034604|SUPERIORITY||Difference|-14.6||||0.0005|TWO_SIDED|95.0|-22.7|-6.5||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-6.5|-22.7|0.0005
91573350|NCT04832971|183034604|OTHER||Difference|-28.4|||<|0.0001|TWO_SIDED|95.0|-36.6|-20.3||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-20.3|-36.6|<.0001
91573351|NCT04832971|183034604|SUPERIORITY||Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-38.4|-22.4||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 20||-22.4|-38.4|<.0001
91573352|NCT04832971|183034604|SUPERIORITY||Difference|-12.0||||0.0039|TWO_SIDED|95.0|-20.2|-3.9||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-3.9|-20.2|0.0039
91573353|NCT04832971|183034604|SUPERIORITY||Difference|-21.6|||<|0.0001|TWO_SIDED|95.0|-29.8|-13.4||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-13.4|-29.8|<.0001
91573354|NCT04832971|183034604|SUPERIORITY||Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-32.6|-16.5||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 24||-16.5|-32.6|<.0001
91573355|NCT04832971|183034604|SUPERIORITY||Difference|-8.4||||0.0343|TWO_SIDED|95.0|-16.2|-0.6||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-0.6|-16.2|0.0343
91573356|NCT04832971|183034604|SUPERIORITY||Difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-25.6|-9.8||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-9.8|-25.6|<.0001
91573357|NCT04832971|183034604|SUPERIORITY||Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-29.3|-13.8||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 28||-13.8|-29.3|<.0001
91573358|NCT04832971|183034604|SUPERIORITY||Difference|-7.8||||0.0501|TWO_SIDED|95.0|-15.6|0.0||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||0.0|-15.6|0.0501
91573359|NCT04832971|183034604|SUPERIORITY||Difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-27.9|-12.2||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-12.2|-27.9|<.0001
91573360|NCT04832971|183034604|SUPERIORITY||Difference|-15.8|||<|0.0001|TWO_SIDED|95.0|-23.5|-8.1||Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening \[≥100 mg/dL versus \<100 mg/dL\]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model Repeated Measures (MMRM)|||Week 36||-8.1|-23.5|<.0001
91573361|NCT01107899|183034619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.|Regression, Linear|||||||<0.001
91573362|NCT01107899|183034621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
91573363|NCT01107899|183034621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
91573364|NCT01107899|183034621|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||0.025
91573365|NCT03584152|183034629|NON_INFERIORITY|The null hypothesis stated that the combination of treatment arm B is worse than the combination of treatment arm A by more than -Δ, where -Δ is the 'non-inferiority margin.'||||||0.156||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.156
91573366|NCT03584152|183034630|OTHER|||||||0.112||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.112
91573367|NCT03584152|183034631|OTHER|||||||0.803||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.803
91573368|NCT03584152|183034632|OTHER|||||||0.403||||||The a priori threshold for statistical significance was \< 0.05.|Chi-squared|||||||0.403
91573369|NCT03584152|183034633|OTHER|||||||0.405||||||The a priori threshold for statistical significance was \< 0.05.|Chi-squared|||Difference between-groups in nausea||||0.405
91573370|NCT03584152|183034633|OTHER|||||||0.001||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||Difference between-groups in itchiness||||0.001
91573371|NCT03584152|183034633|OTHER|||||||0.571||||||The a priori threshold for statistical significance was \< 0.05.|Chi-squared|||Difference between-groups in constipation||||0.571
91573372|NCT03584152|183034633|OTHER|||||||0.078||||||The a priori threshold for statistical significance was \< 0.05.|Chi-squared|||Difference between-groups in dizziness||||0.078
91573373|NCT03584152|183034633|OTHER|||||||0.724||||||The a priori threshold for statistical significance was \< 0.05.|Chi-squared|||Difference between-groups in bleeding||||0.724
91573374|NCT03584152|183034633|OTHER|||||||0.795||||||The a priori threshold for statistical significance was \< 0.05.|Chi-squared|||Difference between-groups in headache||||0.795
91573375|NCT03584152|183034633|OTHER|||||||0.188||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||"Difference between-groups in other side effects"||||0.188
91573376|NCT03584152|183034634|OTHER|||||||0.7318||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Difference in change in SCHNOS-O||||0.7318
91573377|NCT03584152|183034634|OTHER|||||||0.5267||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Difference in change in SCHNOS-C||||0.5267
91573378|NCT03584152|183034635|OTHER|||||||0.9158||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Difference in change in VAS-F||||0.9158
91573379|NCT03584152|183034636|OTHER|||||||0.5351||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||Difference in change in VAS-A||||0.5351
91573380|NCT03584152|183034637|OTHER|||||||0.378||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.378
91573381|NCT03584152|183034638|OTHER|||||||0.195||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.195
91573382|NCT03584152|183034639|OTHER|||||||0.682|||||||Wilcoxon (Mann-Whitney)|||||||0.682
91573383|NCT04024462|183034640|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.99|1.15|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm B SC dose is inferior to the pertuzumab Arm A IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.15|0.99|
91573384|NCT04024462|183034641|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.55|||||TWO_SIDED|90.0|1.44|1.67|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.67|1.44|
91573385|NCT04024462|183034642|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|-0.88|||||TWO_SIDED|95.0|-15.21|13.45|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||13.45|-15.21|
91573386|NCT01351805|183034652|OTHER|Test of change from baseline as above.|Percent change in geometric means|8.19||||0.02|TWO_SIDED|95.0|1.52|15.31||IL-6 from baseline to one year: overall % change= 8.19% (95%CI 1.52-15.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||15.31|1.52|0.02
91573387|NCT01351805|183034652|OTHER|Test of change from baseline as above.|Percent change in geometric means|-0.73||||0.97|TWO_SIDED|95.0|-6.87|5.81||4\. IL-6 from baseline to one year: overall % change= -0.73% (95%CI -6.87 to 5.81).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||5.81|-6.87|0.97
91573388|NCT01351805|183034652|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1,p for interaction between strata.||||||0.12||||||Test of multiplicative interaction between the effects of the two supplements|p for interaction|||Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year||||0.12
91573389|NCT01351805|183034653|OTHER|Test of change from baseline as above.|Percent change in geometric means|7.12||||0.16|TWO_SIDED|95.0|-1.81|16.87||3\. HsCRP from baseline to one year: overall % change= 7.12% (95%CI -1.81-16.78).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||16.87|-1.81|0.16
91573390|NCT01351805|183034653|OTHER|Test of change from baseline as above.|Percent change in geometric means|-3.89||||0.44|TWO_SIDED|95.0|-11.92|4.86||6\. HsCRP from baseline to one year: overall % change= -3.89% (95%CI -11.92-4.86).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||4.86|-11.92|0.44
91573391|NCT01351805|183034653|SUPERIORITY|||||||0.38|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.38
91573392|NCT01351805|183034654|OTHER|Test of change from baseline as above.|Percent change in geometric means|0.63||||0.57|TWO_SIDED|95.0|-1.03|2.31||2\. TNFR2 from baseline to one year: overall % change= 0.63% (95%CI -1.03 to 2.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||2.31|-1.03|0.57
91573393|NCT01351805|183034654|OTHER|Test of change from baseline as above.|Percent change in geometric means|-1.27||||0.13|TWO_SIDED|95.0|-2.89|0.39||5\. TNFR2 from baseline to one year: overall % change= -1.27% (95%CI -2.89 to 0.39).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||0.39|-2.89|0.13
91573394|NCT01351805|183034654|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1 with p for interaction between strata.||||||0.74|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.74
91573395|NCT01351805|183034655|OTHER||Cox Proportional Hazard|0.78||||0.05|TWO_SIDED|95.0|0.61|0.99|||Regression, Cox|||||0.99|0.61|0.05
91573396|NCT01351805|183034655|SUPERIORITY||Cox Proportional Hazard|0.85||||0.19|TWO_SIDED|95.0|0.67|1.08|||Regression, Cox|||||1.08|0.67|0.19
91573397|NCT01351805|183034655|SUPERIORITY|||||||0.2|||||||P for interaction|p multiplicative interaction between effects of vitamin D and n-3 fa supplements||Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.||||0.20
91573398|NCT01351805|183034656|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to omega-3 fatty acids or omega-3 fatty acid placebo, regardless of vitamin D randomization status.||||||0.77||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Repeated measures model with censoring for total knee replacement.||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.||||0.77
91573399|NCT01351805|183034656|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to vitamin D or vitamin D placebo, regardless of omega-3 fatty acid randomization status.||||||0.41||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Linear time by treatment interaction (comparing change in WOMAC pain over time in two randomized groups)||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.|We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).|||0.41
91573400|NCT01351805|183034656|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.42|TWO_SIDED||||||Regression, Linear|||Active n3fa vs placebo n3fa among those on placebo vitamin D.||||0.42
91573401|NCT01351805|183034656|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.8||0.18|TWO_SIDED||||||Regression, Linear|||Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.||||0.18
91573402|NCT01351805|183034656|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|1.89||0.84|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.||||0.84
91573403|NCT01351805|183034656|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.8||0.76|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.||||0.76
91573404|NCT01351805|183034657|SUPERIORITY||Hazard Ratio (HR)|1.0|||<|0.05|TWO_SIDED|95.0||||HR with 95%CI|Regression, Cox|||HR for incident autoimmune disease in intervention groups vs. placebo (ref=1.0) using Cox models with 95% confidence intervals||||<0.05
91573405|NCT04292470|183034660|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
91573406|NCT04292470|183034661|SUPERIORITY|||||||0.09|||||||ANOVA|||For statistical testing, we used a general linear model of change in GERD symptoms from baseline to 8 weeks adjusted for the natural log of the index value (of the ratio of the change in skin conductance between patient and physician at baseline) and randomization assignment.||||0.09
91573407|NCT02906020|183034676|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.87|=|0.1679|TWO_SIDED|95.0|-1.1|6.27||The threshold for statistical significance was 0.05.|MMRM|||Least-squares (LS) mean, standard errors (SE) and p-value were estimated from mixed-effect model with repeated measures (MMRM) analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||6.27|-1.10|=0.1679
91573408|NCT02906020|183034677|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.85|=|0.5996|TWO_SIDED|95.0|-4.63|2.68||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||2.68|-4.63|=0.5996
91573409|NCT02906020|183034678|SUPERIORITY||LS mean difference|4.13|STANDARD_ERROR_OF_MEAN|2.13|=|0.0535|TWO_SIDED|95.0|-0.06|8.32||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction||8.32|-0.06|=0.0535
91573410|NCT02906020|183034679|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.08|=|0.74|TWO_SIDED|95.0|-0.12|0.17||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value: estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction.||0.17|-0.12|=0.7400
91573411|NCT02701062|183034683|SUPERIORITY|||||||0.2593|||||||Fisher Exact|||||||0.2593
91573412|NCT02701062|183034684|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91573413|NCT02701062|183034685|SUPERIORITY|||||||0.1238|||||||Fisher Exact|||||||0.1238
91573414|NCT02701062|183034686|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||LOS (Total)||||0.6603
91573415|NCT02701062|183034686|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
91573416|NCT02701062|183034686|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
91573417|NCT02701062|183034687|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||||||0.6603
91573418|NCT02701062|183034687|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
91573419|NCT02701062|183034687|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
91573420|NCT02701062|183034688|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Reoperation||||0.5442
91573421|NCT02701062|183034688|SUPERIORITY|||||||0.2598|||||||Fisher Exact|||ED Visit||||0.2598
91573422|NCT02701062|183034688|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Neurologic Consult||||0.5442
91573423|NCT02701062|183034688|SUPERIORITY|||||||0.2921|||||||Fisher Exact|||Hospital Readmission (per subject)||||0.2921
91573424|NCT06193967|183034692|OTHER||||||>|0.05|||||||ANOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM frequency (number of days with tracking). A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573425|NCT06193967|183034692|OTHER||||||>|0.05|||||||ANOVA||||To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM frequency (number of days with tracking). A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573426|NCT06193967|183034693|OTHER||||||<|0.001|||||||ANOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|"Linear mixed-factor ANOVA was used with between-subject factors of praise and gamification status, a within-subject factor of time (week), and a dependent variable of DSM frequency.~Results reflect outcomes for main effect of time."|||<0.001
91573427|NCT06193967|183034694|SUPERIORITY||||||>|0.05|||||||ANOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (proportion of items tracked on day of intake). A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573428|NCT06193967|183034694|OTHER||||||>|0.05|||||||ANOVA||||To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (proportion of items tracked on day of intake). A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573429|NCT06193967|183034695|OTHER|||||||0.01|||||||ANOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|"Linear mixed-factor ANOVA was used with between-subject factors of praise and gamification status, a within-subject factor of time (week), and a dependent variable of DSM timing (Proportion of Items Tracked on Day of Intake).~Results reflect outcomes for main effect of time."|||0.01
91573430|NCT06193967|183034696|OTHER||||||>|0.05|||||||ANOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (number of logging sessions). A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573431|NCT06193967|183034696|OTHER||||||>|0.05|||||||ANOVA||||To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial ANOVA was conducted with gamification and caregiver praise status as the independent variables and a dependent variable of DSM timing (number of logging sessions). A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573432|NCT06193967|183034697|OTHER||||||<|0.0001|||||||ANOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|"Linear mixed-factor ANOVA was used with between-subject factors of praise and gamification status, a within-subject factor of time (week), and a dependent variable of DSM timing (number of loging sessions).~Results reflect outcomes for main effect of time."|||<0.0001
91573433|NCT06193967|183034698|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of intrinsic motivation at follow-up, and a covariate of intrinsic motivation at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573434|NCT06193967|183034698|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of intrinsic motivation at follow-up, and a covariate of intrinsic motivation at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573435|NCT06193967|183034699|OTHER||||||>|0.05|||||||ANCOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of scores for child motivation to change eating behaviors at follow-up, and a covariate of baseline scores. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573436|NCT06193967|183034699|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on motivation, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dependent variable of scores for child motivation to change eating behaviors at follow-up, and a covariate of baseline scores. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573437|NCT06193967|183034700|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573438|NCT06193967|183034700|OTHER||||||>|0.05|||||||ANCOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573439|NCT06193967|183034701|OTHER||||||>|0.05|||||||ANCOVA|||A standard alpha level of ≥ 0.05 was used to determine statistical significance.|To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573440|NCT06193967|183034701|OTHER|||||||0.03|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||0.03
91573441|NCT06193967|183034702|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573442|NCT06193967|183034702|OTHER|||||||0.02|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||0.02
91573443|NCT06193967|183034703|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573444|NCT06193967|183034703|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573445|NCT06193967|183034704|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573446|NCT06193967|183034704|OTHER||||||>|0.05|||||||ANCOVA||||To determine the main effects of positive reinforcement on dietary intake, a 2x2 factorial ANCOVA was conducted with gamification and caregiver praise status as the independent variables, a dietary intake at follow-up, and a covariate of dietary intake at baseline. A gamification\*caregiver praise interaction term was also included in the model to test for interactive effects.|||>0.05
91573447|NCT01124097|183034743|SUPERIORITY_OR_OTHER|||||||0.9321|||||||Dunnett's test|||||||0.9321
91573448|NCT01124097|183034743|SUPERIORITY_OR_OTHER|||||||0.261|||||||Dunnett's test|||||||0.2610
91573449|NCT01124097|183034743|SUPERIORITY_OR_OTHER|||||||0.4764|||||||Dunnett's test|||||||0.4764
91573450|NCT05878873|183034798|OTHER||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.027||0.007|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44.|This estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.007
91573451|NCT05878873|183034798|OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.032||0.008|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in healthy controls.||||0.008
91573452|NCT05878873|183034799|OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0141||0.014|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|This estimate calculation is TENS ON - TENS OFF at Visit 2.|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.014
91573453|NCT05878873|183034799|OTHER||Mean Difference (Net)|-0.0058|STANDARD_ERROR_OF_MEAN|0.167||0.878|TWO_SIDED|||||This value was corrected with false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF at Visit 2|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in healthy controls.||||0.878
91573454|NCT05878873|183034800|OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.018||0.898|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.898
91573455|NCT05878873|183034800|OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.698|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in healthy controls.||||0.698
91573456|NCT00559377|183034837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.42|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO Hypoxic Volume to overall survival||||.42
91573457|NCT00559377|183034837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.87|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO T:Bmax to overall survival||||.87
91573458|NCT00559377|183034838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.58|TWO_SIDED||||||Regression, Cox|||This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival||||.58
91573459|NCT00559377|183034838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED||||||Regression, Cox|||This outcome is for comarison of FMISO T:Bmax to progression-free survival||||.98
91573460|NCT00559377|183034839|SUPERIORITY_OR_OTHER||Spearman Correlation|0.004|||<|0.05|TWO_SIDED||||||Spearman Correlation|||The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.||||<0.05
91573461|NCT00203047|183034862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.11820976||0.8023|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA|||||0.20|-0.26|0.8023
91573462|NCT02229227|183034866|NON_INFERIORITY|If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17||Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.|t-test, 2 sided||Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.|||0.17|-0.05|<0.0001
91573463|NCT02229227|183034868|OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.31|0.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||0.60|0.31|<0.0001
91573464|NCT02229227|183034869|SUPERIORITY||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-3.82|-4.93|<0.0001
91573465|NCT02229227|183034870|OTHER||Mean Difference (Net)|-1.21|||||TWO_SIDED|95.0|-1.43|-1.0|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.|Week 4||-1.00|-1.43|
91573466|NCT02229227|183034870|OTHER||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-2.05|-1.55|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.|Week 5||-1.55|-2.05|
91573467|NCT02229227|183034870|OTHER||Mean Difference (Net)|-3.17|||||TWO_SIDED|95.0|-3.51|-2.82|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.|Week 10||-2.82|-3.51|
91573468|NCT02229227|183034870|OTHER||Mean Difference (Net)|-4.01|||||TWO_SIDED|95.0|-4.48|-3.54|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.|Week 18||-3.54|-4.48|
91573469|NCT02229227|183034870|OTHER||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.|Week 26||-3.82|-4.93|<0.0001
91573470|NCT02229227|183034871|SUPERIORITY||Mean Difference (Final Values)|-60.83|||<|0.0001|TWO_SIDED|95.0|-66.57|-55.1|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-55.10|-66.57|<0.0001
91573471|NCT02229227|183034872|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.12|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.07|-0.18|<0.0001
91573472|NCT02229227|183034872|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.02|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||-0.02|-0.15|<0.0001
91573473|NCT02229227|183034872|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.01|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.17|-0.01|<0.0001
91573474|NCT02229227|183034872|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.11|||<|0.0001|TWO_SIDED|95.0|0.01|0.21|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||0.21|0.01|<0.0001
91573475|NCT02229227|183034872|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||0.17|-0.05|<0.0001
91573476|NCT02229227|183034873|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-0.25|-0.86|0.0004
91573477|NCT02229227|183034874|OTHER||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.84|-0.24|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.24|-0.84|
91573478|NCT02229227|183034874|OTHER||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.51|0.13|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||0.13|-0.51|
91573479|NCT02229227|183034874|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-0.85|-0.22|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-0.22|-0.85|
91573480|NCT02229227|183034874|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||-0.25|-0.86|0.0004
91573481|NCT02229227|183034875|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.31|0.71|0.7026
91573482|NCT02229227|183034876|OTHER||Odds Ratio (OR)|1.17||||0.2883|TWO_SIDED|95.0|0.84|1.64||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4|Week 4||1.64|0.84|0.2883
91573483|NCT02229227|183034876|OTHER||Odds Ratio (OR)|0.82||||0.3034|TWO_SIDED|95.0|0.59|1.15||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.15|0.59|0.3034
91573484|NCT02229227|183034876|OTHER||Odds Ratio (OR)|0.71||||0.0151|TWO_SIDED|95.0|0.52|0.98||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.98|0.52|0.0151
91573485|NCT02229227|183034876|OTHER||Odds Ratio (OR)|0.75||||0.0518|TWO_SIDED|95.0|0.54|1.03||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.03|0.54|0.0518
91573486|NCT02229227|183034876|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.31|0.71|0.7026
91573487|NCT02229227|183034877|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.17|0.63|0.2298
91573488|NCT02229227|183034878|OTHER||Odds Ratio (OR)|1.32||||0.2143|TWO_SIDED|95.0|0.78|2.23||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||2.23|0.78|0.2143
91573489|NCT02229227|183034878|OTHER||Odds Ratio (OR)|1.24||||0.4703|TWO_SIDED|95.0|0.8|1.91||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.91|0.80|0.4703
91573490|NCT02229227|183034878|OTHER||Odds Ratio (OR)|0.81||||0.2139|TWO_SIDED|95.0|0.58|1.14||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||1.14|0.58|0.2139
91573491|NCT02229227|183034878|OTHER||Odds Ratio (OR)|0.81||||0.079|TWO_SIDED|95.0|0.59|1.11||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.11|0.59|0.0790
91573492|NCT02229227|183034878|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.17|0.63|0.2298
91573493|NCT02229227|183034879|OTHER||Odds Ratio (OR)|1.08||||0.8292|TWO_SIDED|95.0|0.24|4.77||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.77|0.24|0.8292
91573494|NCT02229227|183034881|OTHER||Mean Difference (Final Values)|-56.38|||||TWO_SIDED|95.0|-59.19|-53.57|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.57|-59.19|
91573495|NCT02229227|183034881|OTHER||Mean Difference (Final Values)|-63.7|||||TWO_SIDED|95.0|-67.78|-59.62|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-59.62|-67.78|
91573496|NCT02229227|183034881|OTHER||Mean Difference (Final Values)|-62.0|||||TWO_SIDED|95.0|-67.29|-56.7|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-56.70|-67.29|
91573497|NCT02229227|183034882|SUPERIORITY||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-2.25|0.3|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||0.30|-2.25|
91573498|NCT02229227|183034882|OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.64|2.33|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||2.33|-1.64|
91573499|NCT02229227|183034882|OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-2.21|2.69|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||2.69|-2.21|
91573500|NCT02229227|183034882|OTHER||Mean Difference (Final Values)|0.39||||0.7699|TWO_SIDED|95.0|-2.25|3.04|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||3.04|-2.25|0.7699
91573501|NCT02229227|183034883|OTHER||Mean Difference (Final Values)|-56.05|||||TWO_SIDED|95.0|-58.17|-53.94|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.94|-58.17|
91573502|NCT02229227|183034883|OTHER||Mean Difference (Final Values)|-64.76|||||TWO_SIDED|95.0|-67.68|-61.85|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-61.85|-67.68|
91573503|NCT02229227|183034883|OTHER||Mean Difference (Final Values)|-62.92|||||TWO_SIDED|95.0|-66.69|-59.15|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-59.15|-66.69|
91573504|NCT02229227|183034883|SUPERIORITY||Mean Difference (Final Values)|-61.83|||<|0.0001|TWO_SIDED|95.0|-65.85|-57.81|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|week 26||-57.81|-65.85|<0.0001
91573505|NCT02229227|183034885|OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.52|4.86||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.86|2.52|<0.0001
91573506|NCT02229227|183034886|OTHER||Odds Ratio (OR)|2.36|||<|0.0001|TWO_SIDED|95.0|1.54|3.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||3.60|1.54|<0.0001
91573507|NCT02229227|183034887|OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.21|6.48||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||6.48|2.21|<0.0001
91573508|NCT00340704|183034926|SUPERIORITY_OR_OTHER||Slope|1.0039|STANDARD_ERROR_OF_MEAN|0.1725||||95.0|0.6499|1.3579|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality for Cmax,ss was explored based on the regression model.||1.3579|0.6499|
91573509|NCT00340704|183034930|SUPERIORITY_OR_OTHER||Slope|0.98|STANDARD_ERROR_OF_MEAN|0.1884||||95.0|0.5934|1.3666|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.|Dose proportionality for AUCτ,ss was explored based on the regression model.||1.3666|0.5934|
91573510|NCT00121667|183034938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.53|-0.92|<.0001
91573511|NCT00121667|183034938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.02|-0.63||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.63|-1.02|<.0001
91573512|NCT00121667|183034938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.52||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.52|-0.91|<.0001
91573513|NCT00121667|183034939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.55|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-22.55|-8.55||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-8.55|-22.55|<.0001
91573514|NCT00121667|183034939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.28|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-30.29|-16.27||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-16.27|-30.29|<.0001
91573515|NCT00121667|183034939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.74|STANDARD_ERROR_OF_MEAN|3.6|<|0.0001|TWO_SIDED|95.0|-28.81|-14.68||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-14.68|-28.81|<.0001
91573516|NCT00121667|183034940|SUPERIORITY_OR_OTHER||Difference in Proportions|20.5|||<|0.0001|TWO_SIDED|95.0|10.6|30.5||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||30.5|10.6|<.0001
91573517|NCT00121667|183034940|SUPERIORITY_OR_OTHER||Difference in Proportions|27.0|||<|0.0001|TWO_SIDED|95.0|17.0|36.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||36.7|17.0|<.0001
91573518|NCT00121667|183034940|SUPERIORITY_OR_OTHER||Difference in Proportions|27.9|||<|0.0001|TWO_SIDED|95.0|17.7|37.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||37.7|17.7|<.0001
91573519|NCT00121667|183034941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5599.0|STANDARD_ERROR_OF_MEAN|1168.2|<|0.0001|TWO_SIDED|95.0|-7894.0|-3305.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3305|-7894|<.0001
91573520|NCT00121667|183034941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6294.0|STANDARD_ERROR_OF_MEAN|1176.8|<|0.0001|TWO_SIDED|95.0|-8606.0|-3983.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3983|-8606|<.0001
91573521|NCT00121667|183034941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4845.0|STANDARD_ERROR_OF_MEAN|1175.1|<|0.0001|TWO_SIDED|95.0|-7153.0|-2537.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-2537|-7153|<.0001
91573522|NCT01453023|183034973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||||TWO_SIDED|95.0|-8.8|0.4|||||Day 1 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||0.4|-8.8|
91573523|NCT01453023|183034973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-1.1|8.5|||||Day 14 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||8.5|-1.1|
91573524|NCT01453023|183034974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-4.4|6.7|||||Day 1 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||6.7|-4.4|
91573525|NCT01453023|183034974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.0|5.5|||||Day 14 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||5.5|-6.0|
91573526|NCT03178344|183034992|EQUIVALENCE|ANOVA||||||0.7||||||P value threshold is 0.05|ANOVA|||||||0.70
91573527|NCT03178344|183034993|EQUIVALENCE|ANOVA||||||0.71||||||P value threshold is 0.05.|ANOVA|||||||0.71
91573528|NCT04937920|183035060|OTHER||Mean Paired Change from Baseline|-29620.0||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.2
91573529|NCT04937920|183035060|OTHER||Mean Paired Change from Baseline|127195.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
91573530|NCT04937920|183035060|OTHER||Mean Paired Change from Baseline|-41659.0||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.6
91573531|NCT04937920|183035060|OTHER||Mean Paired Change from Baseline|-483.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
91573532|NCT01056263|183035063|SUPERIORITY_OR_OTHER||Five year survival probability|20.6|||||TWO_SIDED|95.0|10.94|32.38||||||Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.||32.38|10.94|
91573533|NCT04556305|183035074|SUPERIORITY|||||||0.409|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.409
91573534|NCT04556305|183035074|SUPERIORITY|||||||0.456|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.456
91573535|NCT04556305|183035074|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.692
91573536|NCT04556305|183035075|SUPERIORITY|||||||0.179|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.179
91573537|NCT04556305|183035075|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.910
91573538|NCT04556305|183035075|SUPERIORITY|||||||0.159|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.159
91573539|NCT04556305|183035076|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
91573540|NCT04556305|183035076|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
91573541|NCT04556305|183035076|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
91573542|NCT04556305|183035077|SUPERIORITY|||||||0.772|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.772
91573543|NCT04556305|183035077|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.107
91573544|NCT04556305|183035077|SUPERIORITY|||||||0.915|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.915
91573545|NCT04556305|183035078|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
91573546|NCT04556305|183035078|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
91573547|NCT04556305|183035078|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
91573548|NCT04556305|183035079|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.487
91573549|NCT04556305|183035079|SUPERIORITY|||||||0.827|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.827
91573550|NCT04556305|183035079|SUPERIORITY|||||||0.908|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.908
91573551|NCT04556305|183035080|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.371
91573552|NCT04556305|183035080|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.633
91573553|NCT04556305|183035080|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.230
91573554|NCT04556305|183035081|SUPERIORITY|||||||0.798|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.798
91573555|NCT04556305|183035081|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.461
91573556|NCT04556305|183035081|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.419
91573557|NCT04556305|183035082|SUPERIORITY|||||||0.619|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.619
91573558|NCT04556305|183035082|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.468
91573559|NCT04556305|183035082|SUPERIORITY|||||||0.387|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.387
91573560|NCT04556305|183035083|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.380
91573561|NCT04556305|183035083|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.759
91573562|NCT04556305|183035083|SUPERIORITY|||||||0.219|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.219
91573563|NCT04556305|183035084|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.995
91573564|NCT04556305|183035084|SUPERIORITY|||||||0.946|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.946
91573565|NCT04556305|183035084|SUPERIORITY|||||||0.593|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.593
91573566|NCT04556305|183035085|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.092
91573567|NCT04556305|183035085|SUPERIORITY|||||||0.245|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.245
91573568|NCT04556305|183035085|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.107
91573569|NCT04556305|183035086|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.244
91573570|NCT04556305|183035086|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.085
91573571|NCT04556305|183035086|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.710
91573572|NCT04556305|183035087|SUPERIORITY|||||||0.491|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.491
91573573|NCT04556305|183035087|SUPERIORITY|||||||0.444|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.444
91573574|NCT04556305|183035087|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.279
91573575|NCT03170518|183035095|SUPERIORITY|Imputed datasets were analyzed using analysis of covariance (ANCOVA) with terms for treatment, stratification factors (antihyperglycemic agent background and age group), and baseline HbA1c.|Least square mean difference|-0.76|||=|0.002|TWO_SIDED|95.0|-1.25|-0.27|||ANCOVA|||||-0.27|-1.25|= 0.002
91573576|NCT03512197|183035130|SUPERIORITY||Hazard Ratio (HR)|1.0239|||||TWO_SIDED|95.0|0.8|1.31||||||||1.31|0.8|
91573577|NCT03512197|183035131|SUPERIORITY||Hazard Ratio (HR)|0.8728|||||TWO_SIDED|95.0|0.59|1.29||||||||1.29|0.59|
91573578|NCT03512197|183035136|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.6|1.63||||||||1.63|0.60|
91573579|NCT03512197|183035137|SUPERIORITY||Hazard Ratio (HR)|1.5866|||||TWO_SIDED|95.0|0.88|2.87||||||||2.87|0.88|
91573580|NCT03512197|183035138|SUPERIORITY||Hazard Ratio (HR)|0.7937|||||TWO_SIDED|95.0|0.41|1.54||||||||1.54|0.41|
91573581|NCT03512197|183035140|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.16||||||partial neutrophil recovery||1.16|0.75|
91573582|NCT03512197|183035140|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.72|1.14||||||full neutrophil recovery||1.14|0.72|
91573583|NCT03512197|183035141|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||partial platelet recovery||1.52|0.87|
91573584|NCT03512197|183035141|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.67|1.0||||||full platelet recovery||1.00|0.67|
91573585|NCT01948076|183035160|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
91573586|NCT01948076|183035161|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|95.0|||||McNemar|||||||0.043
91573587|NCT01431950|183035201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077||||||95.0|-0.039|0.192||||||||0.192|-0.039|
91573588|NCT01210651|183035211|SUPERIORITY_OR_OTHER|||||||0.034||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value \< 0.05 required a priori to reject the null hypothesis.|Regression, Generalized Least Squares|||A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.||||0.034
91573589|NCT01210651|183035212|SUPERIORITY_OR_OTHER|||||||0.02||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.||||0.02
91573590|NCT01210651|183035213|SUPERIORITY_OR_OTHER|||||||0.018||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value \< 0.05 required a priori to reject the null hypothesis.|Fisher Exact|||Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.||||0.018
91573591|NCT01210651|183035214|SUPERIORITY_OR_OTHER|||||||0.5||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.||||0.50
91573592|NCT01210651|183035215|SUPERIORITY_OR_OTHER|||||||0.053||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.||||0.053
91573593|NCT02559310|183035216|NON_INFERIORITY|Non-inferiority Margin = 12.5%.|Treatment Difference (Lef - Mox)|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic.|||2.8|-8.5|
91573594|NCT02559310|183035217|NON_INFERIORITY|Non-inferiority Margin = 10%.|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-8.9|3.9|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.9|-8.9|
91573595|NCT02559310|183035217|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-9.2|4.1|||||Difference in percentage of Success for IACR at test of cure visit. CI computed using continuity-corrected Z-statistic.|||4.1|-9.2|
91573596|NCT02559310|183035218|NON_INFERIORITY|Non-Inferiority Margin = 10%.|Treatment Difference|-2.5|||||TWO_SIDED|95.0|-8.4|3.4|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.4|-8.4|
91573597|NCT02559310|183035218|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.5|||||TWO_SIDED|95.0|-8.7|3.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic|||3.7|-8.7|
91573598|NCT04596540|183035219|SUPERIORITY||Risk Difference (RD)|0.29||||0.0008|TWO_SIDED|97.5|0.1|0.48|||Mantel Haenszel|||||0.48|0.10|0.0008
91573599|NCT04596540|183035219|SUPERIORITY||Risk Difference (RD)|0.35||||0.0002|TWO_SIDED|97.5|0.14|0.56|||Mantel Haenszel|||||0.56|0.14|0.0002
91573600|NCT04596540|183035220|SUPERIORITY||Least Squares (LS) Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|97.5|-5.07|-1.55|||ANCOVA|||||-1.55|-5.07|<0.001
91573601|NCT04596540|183035220|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|97.5|-6.24|-2.66|||ANCOVA|||||-2.66|-6.24|<0.001
91573602|NCT04596540|183035221|SUPERIORITY||LS Mean Difference|-40.1|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|97.5|-60.96|-19.27|||ANCOVA|||||-19.27|-60.96|<.001
91573603|NCT04596540|183035221|SUPERIORITY||LS Mean Difference|-53.6|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|97.5|-74.49|-32.66|||ANCOVA|||||-32.66|-74.49|<.001
91573604|NCT04596540|183035222|SUPERIORITY||LS Mean Difference|6.6|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|97.5|2.52|10.66|||Mixed Models Analysis|||||10.66|2.52|<.001
91573605|NCT04596540|183035222|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.8||0.011|TWO_SIDED|97.5|0.54|8.59|||Mixed Models Analysis|||||8.59|0.54|0.011
91573606|NCT04596540|183035223|SUPERIORITY||Difference|0.3||||0.047|TWO_SIDED|97.5|-0.02|0.62|||Chi-squared|||||0.62|-0.02|0.0470
91573607|NCT04596540|183035223|SUPERIORITY||Difference|0.39||||0.0022|TWO_SIDED|97.5|0.12|0.66|||Chi-squared|||||0.66|0.12|0.0022
91573608|NCT04596540|183035224|SUPERIORITY||Difference|0.28||||0.0096|TWO_SIDED|97.5|0.05|0.51|||Chi-squared|||||0.51|0.05|0.0096
91573609|NCT04596540|183035224|SUPERIORITY||Difference|0.35||||0.0028|TWO_SIDED|97.5|0.1|0.6|||Chi-squared|||||0.60|0.10|0.0028
91573610|NCT04596540|183035225|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|97.5|-7.55|-1.98|||Mixed Models Analysis|||||-1.98|-7.55|<.001
91573611|NCT04596540|183035225|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2||0.003|TWO_SIDED|97.5|-6.42|-0.91|||Mixed Models Analysis|||||-0.91|-6.42|0.003
91573612|NCT04596540|183035226|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|97.5|-0.46|-0.01|||Mixed Models Analysis|||||-0.01|-0.46|0.018
91573613|NCT04596540|183035226|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.785|TWO_SIDED|97.5|-0.25|0.2|||Mixed Models Analysis|||||0.20|-0.25|0.785
91573614|NCT04596540|183035227|SUPERIORITY||LS Mean Difference|0.0||||0.5|TWO_SIDED|97.5|-0.15|0.08|||ANOVA|||||0.08|-0.15|0.500
91573615|NCT04596540|183035227|SUPERIORITY||LS Mean Difference|0.0||||0.421|TWO_SIDED|97.5|-0.15|0.07|||ANOVA|||||0.07|-0.15|0.421
91573616|NCT04596540|183035228|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.634|TWO_SIDED|97.5|-0.22|0.14|||ANOVA|||Treatment Periods 1-3 (Months 1-3)||0.14|-0.22|0.634
91573617|NCT04596540|183035228|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.907|TWO_SIDED|97.5|-0.17|0.19|||ANOVA|||Treatment Periods 1-3 (Month 1-3)||0.19|-0.17|0.907
91573618|NCT01515943|183035264|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.56|TWO_SIDED|97.5|-19.0|11.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Biniomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||11|-19|0.56
91573619|NCT01515943|183035265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.52|TWO_SIDED|97.5|-12.0|22.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Binomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||22|-12|0.52
91573620|NCT01515943|183035271|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||<|0.01|TWO_SIDED|95.0|-27.0|17.0|||Bernard's exact test|A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.||For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.||17|-27|<0.01
91573621|NCT00433511|183035285|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|The primary objective of this trial was to determine whether the addition of bevacizumab improved IDFS. A two-step hierarchical approach was used. In the 1st step, Arm C was to be compared to Arm A. If Arm C significantly improved IDFS relative to Arm A, then in the 2nd step, a comparison of Arm B to Arm A was to be performed. If the treatment in both Arm C and Arm B significantly improved IDFS relative to Arm A, then a comparison of Arm C to Arm B was to be performed with respect to IDFS.||1.06|0.71|0.17
91573622|NCT00433511|183035286|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.41|TWO_SIDED|95.0|0.68|1.17||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|||1.17|0.68|0.41
91573623|NCT00433511|183035286|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.77|1.33||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm B/Arm A|||1.33|0.77|0.92
91573624|NCT00433511|183035286|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.36|TWO_SIDED|95.0|0.72|1.13||Two-sided; based on stratified test using stratification factors at randomization|Regression, Cox||Hazard ratio: Arm C/Arm B|||1.13|0.72|0.36
91573625|NCT02349152|183035288|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.|Risk Ratio (RR)|1.9||||0.001|TWO_SIDED|95.0|1.3|3.0|||Chi-squared|||The null hypothesis that there was no difference in the percentage of patients with two or more blood glucose values greater than 180mg/dl between the two groups. Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%.||3.0|1.3|0.001
91573626|NCT02349152|183035289|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||||||0.004
91573627|NCT02349152|183035290|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.||||||0.01|||||||Fisher Exact|||||||0.01
91573628|NCT02349152|183035291|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0001|||||||t-test, 2 sided|||Mean Intraoperative Blood Glucose||||0.0001
91573629|NCT02349152|183035291|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0003|||||||t-test, 2 sided|||Peak Intraoperative Blood Glucose||||0.0003
91573630|NCT02349152|183035291|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.98|||||||t-test, 2 sided|||Lowest Intraoperative Blood Glucose||||0.98
91573631|NCT02349152|183035292|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.14|||||||t-test, 2 sided|||Mean post-operative glucose||||0.14
91573632|NCT02349152|183035292|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.25|||||||t-test, 2 sided|||Peak Postoperative Blood Glucose||||0.25
91573633|NCT02349152|183035293|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.49|||||||t-test, 2 sided|||||||0.49
91573634|NCT02349152|183035295|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.401|||||||t-test, 2 sided|||Prebypass||||0.401
91573635|NCT02349152|183035295|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||30 minutes after the start of CPB||||<0.0001
91573636|NCT02349152|183035295|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of CPB||||<0.0001
91573637|NCT02349152|183035295|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of Surgery||||<0.0001
91573638|NCT02349152|183035295|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.021|||||||t-test, 2 sided|||Postoperative (8 hours)||||0.021
91573639|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.58|||||||t-test, 2 sided|||Analyzing the IL-1b Pre bypass||||0.580
91573640|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.815|||||||t-test, 2 sided|||Analyzing the IL-1b CPB-30||||0.815
91573641|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.715|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.715
91573642|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.33|||||||t-test, 2 sided|||Analyzing the IL-1b post-bypass||||0.330
91573643|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.651|||||||t-test, 2 sided|||Analyzing the IL-1b 8 HR||||0.651
91573644|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.439|||||||t-test, 2 sided|||Analyzing the IL-6 Pre bypass||||0.439
91573645|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.284|||||||t-test, 2 sided|||Analyzing the IL-6 CPB-30||||0.284
91573646|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.779|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.779
91573647|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.274|||||||t-test, 2 sided|||Analyzing the IL-6 post-bypass||||0.274
91573648|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.601|||||||t-test, 2 sided|||Analyzing the IL-6 8HR||||0.601
91573649|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.315|||||||t-test, 2 sided|||Analyzing the TNFa Pre-bypass||||0.315
91573650|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the TNFa CPB-30||||0.062
91573651|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.09|||||||t-test, 2 sided|||Analyzing the TNFa CPB-END||||0.090
91573652|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||Analyzing the TNFa- post-bypass||||0.004
91573653|NCT02349152|183035296|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.074|||||||t-test, 2 sided|||Analyzing the TNFa-8HR||||0.074
91573654|NCT02349152|183035297|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.74|||||||t-test, 2 sided|||Analyzing the ACTH Pre-bypass group||||0.740
91573655|NCT02349152|183035297|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-30 group.||||<0.0001
91573656|NCT02349152|183035297|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-END||||<0.0001
91573657|NCT02349152|183035297|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH post-bypass||||<0.0001
91573658|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.014|||||||t-test, 2 sided|||Analyzing the ACTH 8-hr||||0.014
91573659|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.1|||||||t-test, 2 sided|||Analyzing the GH- Pre-bypass||||0.100
91573660|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||GH-CPB-30||||<0.0001
91573661|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.009|||||||t-test, 2 sided|||Analyzing the GH-CPB-END||||0.009
91573662|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.046|||||||t-test, 2 sided|||GH-Post-bypass||||0.046
91573663|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.695|||||||t-test, 2 sided|||Analyzing the GH-8-hr||||0.695
91573664|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.455|||||||t-test, 2 sided|||Analyzing the Glucagon Pre Bypass||||0.455
91573665|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.059|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-30||||0.059
91573666|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.175|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-END||||0.175
91573667|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the Glucagon Post-bypass||||0.062
91573668|NCT02349152|183035297|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.261|||||||t-test, 2 sided|||Analyzing the Glucagon 8-hr||||0.261
91573669|NCT02349152|183035298|SUPERIORITY|||||||0.06|||||||Chi-squared|||30-day mortality||||0.06
91573670|NCT02349152|183035298|SUPERIORITY|||||||0.03|||||||Chi-squared|||30-day readmission||||0.03
91573671|NCT02349152|183035298|SUPERIORITY|||||||0.24|||||||Chi-squared|||Cerebral Vascular Accident||||0.24
91573672|NCT02349152|183035298|SUPERIORITY|||||||0.93|||||||Chi-squared|||Prolonged Mechanical Ventilation||||0.93
91573673|NCT02349152|183035298|SUPERIORITY|||||||1|||||||Chi-squared|||Renal Failure||||1
91573674|NCT02349152|183035298|SUPERIORITY|||||||0.1|||||||Chi-squared|||Atrial Fibrillation||||0.10
91573675|NCT02349152|183035298|SUPERIORITY|||||||1|||||||Chi-squared|||cardiac arrest||||1
91573676|NCT02349152|183035299|SUPERIORITY|||||||0.205|||||||t-test, 2 sided|||Hrs 0-6||||0.205
91573677|NCT02349152|183035299|SUPERIORITY|||||||0.339|||||||t-test, 2 sided|||Hrs 7-12||||0.339
91573678|NCT02349152|183035299|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Hrs 13-18||||0.006
91573679|NCT02349152|183035299|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||Hrs 19-24||||0.747
91573680|NCT02349152|183035299|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Hrs 25-30||||0.568
91573681|NCT02349152|183035299|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||Hrs 31-36||||0.924
91573682|NCT02349152|183035299|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Hrs 37-42||||0.501
91573683|NCT02349152|183035299|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||Hrs 43-48||||0.977
91573684|NCT02349152|183035303|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
91573685|NCT01732549|183035321|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0315||||||Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.|Log Rank|||Stratified\[a\]||||=0.0315
91573686|NCT01732549|183035321|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0344|||||||Log Rank|||Unstratified\[b\]||||=0.0344
91573687|NCT01732549|183035322|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.443|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.4430
91573688|NCT01732549|183035323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||0.5219
91573689|NCT01732549|183035324|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.5442|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.5442
91573690|NCT01732549|183035325|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.1120
91573691|NCT01732549|183035326|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2491|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) \& region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.2491
91573692|NCT03994731|183035329|SUPERIORITY||Stratified difference in proportions|32.31|STANDARD_ERROR_OF_MEAN|8.157|<|0.0001|TWO_SIDED|95.0|16.3|48.3||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (Pegloticase+MTX - Pegloticase+Placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tophi presence at baseline: yes, no) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||48.3|16.3|< 0.0001
91573693|NCT03994731|183035330|SUPERIORITY||response rate difference|29.05|STANDARD_ERROR_OF_MEAN|8.084||0.0003|TWO_SIDED|95.0|13.2|44.9||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||response rate difference (Peg+MTX - Peg+Placebo)|||44.9|13.2|0.0003
91573694|NCT03994731|183035331|SUPERIORITY||Difference|22.8||||0.0482|TWO_SIDED|95.0|1.2|44.4||The comparison of complete response between groups is performed using an unstratified chi-squared test.|Chi-squared||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||44.4|1.2|0.0482
91573695|NCT03994731|183035332|SUPERIORITY||Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.084||0.6287|TWO_SIDED|95.0|-0.21|0.13||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||0.13|-0.21|0.6287
91573696|NCT03994731|183035333|SUPERIORITY||Difference|-8.43|STANDARD_ERROR_OF_MEAN|3.766||0.0272|TWO_SIDED|95.0|-15.88|-0.97||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-0.97|-15.88|0.0272
91573697|NCT03994731|183035334|SUPERIORITY||Difference|-10.16|STANDARD_ERROR_OF_MEAN|2.531||0.0222|TWO_SIDED|95.0|-18.84|-1.48||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-1.48|-18.84|0.0222
91573698|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|1.1||||0.9998|TWO_SIDED|95.0|0.2|4.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||4.9|0.2|0.9998
91573699|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9345|TWO_SIDED|95.0|0.3|7.5|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.5|0.3|0.9345
91573700|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|0.5||||0.5836|TWO_SIDED|95.0|0.1|2.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||2.1|0.1|0.5836
91573701|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|2.4||||0.4844|TWO_SIDED|95.0|0.5|10.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||10.6|0.5|0.4844
91573702|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|1.4||||0.9725|TWO_SIDED|95.0|0.3|6.8|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||6.8|0.3|0.9725
91573703|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|0.4||||0.4715|TWO_SIDED|95.0|0.1|1.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.9|0.1|0.4715
91573704|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|2.2||||0.5969|TWO_SIDED|95.0|0.5|9.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||9.6|0.5|0.5969
91573705|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|0.3||||0.2043|TWO_SIDED|95.0|0.1|1.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.4|0.1|0.2043
91573706|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9388|TWO_SIDED|95.0|0.3|7.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.4|0.3|0.9388
91573707|NCT03635086|183035375|OTHER||Geometric Mean Ratio Estimate|5.2||||0.0251|TWO_SIDED|95.0|1.2|23.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||23.1|1.2|0.0251
91573708|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.6||||0.5263|TWO_SIDED|95.0|0.2|1.6|||ANOVA|||Day 0||1.6|0.2|0.5263
91573709|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
91573710|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
91573711|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
91573712|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.55|TWO_SIDED|95.0|0.6|4.7|||ANOVA|||Day 0||4.7|0.6|0.5500
91573713|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
91573714|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
91573715|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
91573716|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
91573717|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
91573718|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5321|TWO_SIDED|95.0|0.2|1.7|||ANOVA|||Day 28||1.7|0.2|0.5321
91573719|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9983|TWO_SIDED|95.0|0.3|3.9|||ANOVA|||Day 28||3.9|0.3|0.9983
91573720|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8234|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 28||2.1|0.2|0.8234
91573721|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9882|TWO_SIDED|95.0|0.2|2.7|||ANOVA|||Day 28||2.7|0.2|0.9882
91573722|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.3778|TWO_SIDED|95.0|0.6|7.6|||ANOVA|||Day 28||7.6|0.6|0.3778
91573723|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9878|TWO_SIDED|95.0|0.4|4.1|||ANOVA|||Day 28||4.1|0.4|0.9878
91573724|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.8213|TWO_SIDED|95.0|0.5|5.3|||ANOVA|||Day 28||5.3|0.5|0.8213
91573725|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.6716|TWO_SIDED|95.0|0.2|1.9|||ANOVA|||Day 28||1.9|0.2|0.6716
91573726|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.938|TWO_SIDED|95.0|0.2|2.5|||ANOVA|||Day 28||2.5|0.2|0.9380
91573727|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9777|TWO_SIDED|95.0|0.4|4.3|||ANOVA|||Day 28||4.3|0.4|0.9777
91573728|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9997|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 56||4.7|0.3|0.9997
91573729|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9287|TWO_SIDED|95.0|0.3|7.2|||ANOVA|||Day 56||7.2|0.3|0.9287
91573730|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5598|TWO_SIDED|95.0|0.1|2.0|||ANOVA|||Day 56||2.0|0.1|0.5598
91573731|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|3.0||||0.2117|TWO_SIDED|95.0|0.7|13.1|||ANOVA|||Day 56||13.1|0.7|0.2117
91573732|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9699|TWO_SIDED|95.0|0.3|6.6|||ANOVA|||Day 56||6.6|0.3|0.9699
91573733|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.4||||0.446|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.4460
91573734|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.8||||0.292|TWO_SIDED|95.0|0.6|11.9|||ANOVA|||Day 56||11.9|0.6|0.2920
91573735|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.184|TWO_SIDED|95.0|0.1|1.4|||ANOVA|||Day 56||1.4|0.1|0.1840
91573736|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7229|TWO_SIDED|95.0|0.4|9.2|||ANOVA|||Day 56||9.2|0.4|0.7229
91573737|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|6.6||||0.0052|TWO_SIDED|95.0|1.5|28.6|||ANOVA|||Day 56||28.6|1.5|0.0052
91573738|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9777|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 182||3.0|0.2|0.9777
91573739|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9812|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 182||5.3|0.3|0.9812
91573740|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9979|TWO_SIDED|95.0|0.3|4.5|||ANOVA|||Day 182||4.5|0.3|0.9979
91573741|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.588|TWO_SIDED|95.0|0.5|7.9|||ANOVA|||Day 182||7.9|0.5|0.5880
91573742|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7973|TWO_SIDED|95.0|0.4|7.0|||ANOVA|||Day 182||7.0|0.4|0.7973
91573743|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.8992|TWO_SIDED|95.0|0.4|6.0|||ANOVA|||Day 182||6.0|0.4|0.8992
91573744|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.7||||0.2602|TWO_SIDED|95.0|0.7|10.4|||ANOVA|||Day 182||10.4|0.7|0.2602
91573745|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.9991|TWO_SIDED|95.0|0.2|3.6|||ANOVA|||Day 182||3.6|0.2|0.9991
91573746|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9028|TWO_SIDED|95.0|0.4|6.2|||ANOVA|||Day 182||6.2|0.4|0.9028
91573747|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7761|TWO_SIDED|95.0|0.4|6.8|||ANOVA|||Day 182||6.8|0.4|0.7761
91573748|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.7833|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 365||2.1|0.2|0.7833
91573749|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9915|TWO_SIDED|95.0|0.2|2.9|||ANOVA|||Day 365||2.9|0.2|0.9915
91573750|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.998|TWO_SIDED|95.0|0.3|3.0|||ANOVA|||Day 365||3.0|0.3|0.9980
91573751|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.909|TWO_SIDED|95.0|0.4|4.9|||ANOVA|||Day 365||4.9|0.4|0.9090
91573752|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9651|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9651
91573753|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9112|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9112
91573754|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.4||||0.257|TWO_SIDED|95.0|0.7|7.8|||ANOVA|||Day 365||7.8|0.7|0.2570
91573755|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|3.8|||ANOVA|||Day 365||3.8|0.3|0.9999
91573756|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.8||||0.6953|TWO_SIDED|95.0|0.5|6.2|||ANOVA|||Day 365||6.2|0.5|0.6953
91573757|NCT03635086|183035378|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7523|TWO_SIDED|95.0|0.5|5.4|||ANOVA|||Day 365||5.4|0.5|0.7523
91573758|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.5||||0.5263|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 0||1.7|0.1|0.5263
91573759|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
91573760|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
91573761|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
91573762|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.55|TWO_SIDED|95.0|0.6|7.0|||ANOVA|||Day 0||7.0|0.6|0.5500
91573763|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
91573764|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
91573765|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
91573766|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
91573767|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
91573768|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7708|TWO_SIDED|95.0|0.1|2.4|||ANOVA|||Day 28||2.4|0.1|0.7708
91573769|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9966|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9966
91573770|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9503|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 28||3.0|0.2|0.9503
91573771|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9791|TWO_SIDED|95.0|0.2|3.2|||ANOVA|||Day 28||3.2|0.2|0.9791
91573772|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.5739|TWO_SIDED|95.0|0.5|9.8|||ANOVA|||Day 28||9.8|0.5|0.5739
91573773|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9918|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9918
91573774|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9748|TWO_SIDED|95.0|0.3|5.9|||ANOVA|||Day 28||5.9|0.3|0.9748
91573775|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.827|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 28||2.6|0.1|0.8270
91573776|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.893|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 28||2.8|0.1|0.8930
91573777|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 28||4.7|0.3|0.9999
91573778|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9105|TWO_SIDED|95.0|0.1|3.2|||ANOVA|||Day 56||3.2|0.1|0.9105
91573779|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 56||5.5|0.2|1.0000
91573780|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3047|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 56||1.7|0.1|0.3047
91573781|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|5.5||||0.0423|TWO_SIDED|95.0|1.0|29.2|||ANOVA|||Day 56||29.2|1.0|0.0423
91573782|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9213|TWO_SIDED|95.0|0.3|9.1|||ANOVA|||Day 56||9.1|0.3|0.9213
91573783|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.8092|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 56||2.8|0.1|0.8092
91573784|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|9.1||||0.004|TWO_SIDED|95.0|1.7|48.5|||ANOVA|||Day 56||48.5|1.7|0.0040
91573785|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3347|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.3347
91573786|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|5.6||||0.0488|TWO_SIDED|95.0|1.0|30.7|||ANOVA|||Day 56||30.7|1.0|0.0488
91573787|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|17.4||||0.0001|TWO_SIDED|95.0|3.3|92.2|||ANOVA|||Day 56||92.2|3.3|0.0001
91573788|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8831|TWO_SIDED|95.0|0.1|3.0|||ANOVA|||Day 182||3.0|0.1|0.8831
91573789|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
91573790|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8916|TWO_SIDED|95.0|0.1|3.1|||ANOVA|||Day 182||3.1|0.1|0.8916
91573791|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.9||||0.794|TWO_SIDED|95.0|0.4|9.9|||ANOVA|||Day 182||9.9|0.4|0.7940
91573792|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9169|TWO_SIDED|95.0|0.3|8.9|||ANOVA|||Day 182||8.9|0.3|0.9169
91573793|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
91573794|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2563|TWO_SIDED|95.0|0.6|17.1|||ANOVA|||Day 182||17.1|0.6|0.2563
91573795|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9237|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 182||3.3|0.1|0.9237
91573796|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7708|TWO_SIDED|95.0|0.4|10.8|||ANOVA|||Day 182||10.8|0.4|0.7708
91573797|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2661|TWO_SIDED|95.0|0.6|16.9|||ANOVA|||Day 182||16.9|0.6|0.2661
91573798|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7614|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 365||2.6|0.1|0.7614
91573799|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9905|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||Day 365||4.3|0.1|0.9905
91573800|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.933|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 365||3.3|0.1|0.9330
91573801|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9945|TWO_SIDED|95.0|0.2|6.7|||ANOVA|||Day 365||6.7|0.2|0.9945
91573802|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9599|TWO_SIDED|95.0|0.3|8.4|||ANOVA|||Day 365||8.4|0.3|0.9599
91573803|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9942|TWO_SIDED|95.0|0.2|6.4|||ANOVA|||Day 365||6.4|0.2|0.9942
91573804|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.5||||0.4932|TWO_SIDED|95.0|0.5|12.9|||ANOVA|||Day 365||12.9|0.5|0.4932
91573805|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9983|TWO_SIDED|95.0|0.2|4.6|||ANOVA|||Day 365||4.6|0.2|0.9983
91573806|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.9112|TWO_SIDED|95.0|0.3|9.3|||ANOVA|||Day 365||9.3|0.3|0.9112
91573807|NCT03635086|183035387|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7431|TWO_SIDED|95.0|0.4|10.2|||ANOVA|||Day 365||10.2|0.4|0.7431
91573808|NCT02844777|183035440|OTHER|||||||0.9518|||||||ANCOVA|||||||0.9518
91573809|NCT02844777|183035440|OTHER|||||||0.2458|||||||ANCOVA|||||||0.2458
91573810|NCT02844777|183035441|OTHER|||||||0.6201|||||||Fisher Exact|||||||0.6201
91573811|NCT02844777|183035441|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91573812|NCT02844777|183035442|OTHER|||||||0.2912|||||||ANCOVA|||||||0.2912
91573813|NCT02844777|183035442|OTHER|||||||0.4168|||||||ANCOVA|||||||0.4168
91573814|NCT02844777|183035443|OTHER|||||||0.6458|||||||ANCOVA|||||||0.6458
91573815|NCT02844777|183035443|OTHER|||||||0.0721|||||||ANCOVA|||||||0.0721
91573816|NCT02844777|183035444|OTHER|||||||0.42|||||||ANCOVA|||||||0.4200
91573817|NCT02844777|183035444|OTHER|||||||0.0241|||||||ANCOVA|||||||0.0241
91573818|NCT00150618|183035454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||ANCOVA|||||||0.0041
91573819|NCT00150618|183035454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0|||||ANCOVA|||||||0.0176
91573820|NCT00150618|183035454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||ANCOVA|||||||0.0016
91573821|NCT00150618|183035454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
91573822|NCT00150618|183035455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.0010
91573823|NCT00150618|183035455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||ANCOVA|||||||0.0468
91573824|NCT00150618|183035455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
91573825|NCT00150618|183035455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237||95.0|||||ANCOVA|||||||0.0237
91573826|NCT00150618|183035456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074||95.0|||||Cochran-Mantel-Haenszel|||||||0.0074
91573827|NCT00150618|183035456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0|||||Cochran-Mantel-Haenszel|||||||0.1404
91573828|NCT00150618|183035456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0055||95.0|||||Cochran-Mantel-Haenszel|||||||0.0055
91573829|NCT00150618|183035456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||Cochran-Mantel-Haenszel|||||||0.0041
91573830|NCT00150618|183035457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|||||||0.0303
91573831|NCT00150618|183035457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4982||95.0|||||Cochran-Mantel-Haenszel|||||||0.4982
91573832|NCT00150618|183035457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||||||0.0017
91573833|NCT00150618|183035457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
91573834|NCT00150618|183035458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0383||95.0|||||ANCOVA|||Psychosocial category||||0.0383
91573835|NCT00150618|183035458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5859||95.0|||||ANCOVA|||Psychosocial category||||0.5859
91573836|NCT00150618|183035458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136||95.0|||||ANCOVA|||Psychosocial category||||0.2136
91573837|NCT00150618|183035458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||95.0|||||ANCOVA|||Psychosocial category||||0.1483
91573838|NCT03434028|183035464|SUPERIORITY||difference in mortality rate|-0.9||||0.61|TWO_SIDED|95.0|-4.4|2.6|||Z-test|||||2.6|-4.4|0.61
91573839|NCT03434028|183035465|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||The mean values is an estimate from the Kaplan-Meier curve, thus it is correct as reported.|||1.2|-0.5|
91573840|NCT03434028|183035466|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6||||||||1.6|-0.4|
91573841|NCT03434028|183035467|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.2||||||||1.2|-0.8|
91573842|NCT03434028|183035468|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.5|1.3||||||||1.3|-0.5|
91573843|NCT03434028|183035469|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.8|1.0||||||||1.0|-0.8|
91573844|NCT03434028|183035470|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||||1.9|-0.3|
91573845|NCT03434028|183035471|SUPERIORITY||Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-5.1|1.7||||||||1.7|-5.1|
91573846|NCT03434028|183035472|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
91573847|NCT03434028|183035473|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
91573848|NCT03434028|183035474|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||||0.4|-0.3|
91573849|NCT03434028|183035475|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-1.7|1.5||||||||1.5|-1.7|
91573850|NCT03434028|183035476|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-3.7|1.7||||||||1.7|-3.7|
91573851|NCT03434028|183035477|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-3.6|4.7||||||||4.7|-3.6|
91573852|NCT02037776|183035478|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups in Rikkunshito Placebo and Rikkunshito, based on the count of participants categorized in 1 (Significantly improved) through 7 (Much worse), using the Wilcoxon (Mann-Whitney).||||0.038
91573853|NCT02037776|183035479|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in all symptoms of modified FSSG||||0.027
91573854|NCT02037776|183035479|SUPERIORITY|||||||0.089|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in GERD symptoms of modified FSSG||||0.089
91573855|NCT02037776|183035479|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in dyspeptic symptoms of modified FSSG||||0.148
91573856|NCT02037776|183035480|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in total score of PAGI-SYM||||0.051
91573857|NCT02037776|183035480|SUPERIORITY|||||||0.947|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Heartburn/Regurgitation of PAGI-SYM||||0.947
91573858|NCT02037776|183035480|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Nausea/Vomiting of PAGI-SYM||||0.157
91573859|NCT02037776|183035480|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM||||0.004
91573860|NCT02037776|183035480|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Bloating of PAGI-SYM||||0.011
91573861|NCT02037776|183035480|SUPERIORITY|||||||0.245|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Upper Abdominal Pain of PAGI-SYM||||0.245
91573862|NCT02037776|183035480|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Lower Abdominal Pain of PAGI-SYM||||0.387
91573863|NCT02037776|183035481|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
91573864|NCT02037776|183035482|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in PCS of SF-8||||0.270
91573865|NCT02037776|183035482|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in MCS of SF-8||||0.342
91573866|NCT02037776|183035483|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in overall point score of HAD||||0.036
91573867|NCT02037776|183035483|SUPERIORITY|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in depression point score of HAD||||0.084
91573868|NCT02037776|183035483|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in anxiety point score of HAD||||0.022
91573869|NCT02296892|183035484|SUPERIORITY||Difference in Rates|0.7588|||<|0.0001|TWO_SIDED|95.0|0.6903|0.8274|||Cochran-Mantel-Haenszel|||||0.8274|0.6903|<0.0001
91573870|NCT04147858|183035505|SUPERIORITY|||||||0.539|||||||t-test, 2 sided|||||||0.539
91573871|NCT04147858|183035505|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
91573872|NCT04147858|183035506|SUPERIORITY|||||||0.824|||||||t-test, 2 sided|||||||0.824
91573873|NCT04147858|183035506|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91573874|NCT04147858|183035507|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
91573875|NCT04147858|183035507|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||||||0.603
91573876|NCT04147858|183035508|SUPERIORITY|||||||0.871|||||||t-test, 2 sided|||||||0.871
91573877|NCT04147858|183035508|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
91573878|NCT04147858|183035509|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91573879|NCT04147858|183035509|SUPERIORITY|||||||0.626|||||||t-test, 2 sided|||||||0.626
91573880|NCT04147858|183035510|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
91573881|NCT04147858|183035510|SUPERIORITY|||||||0.726|||||||t-test, 2 sided|||||||0.726
91573882|NCT04147858|183035511|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||||||0.888
91573883|NCT04147858|183035511|SUPERIORITY|||||||0.832|||||||t-test, 2 sided|||||||0.832
91573884|NCT04147858|183035512|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||0.536
91573885|NCT04147858|183035512|SUPERIORITY|||||||0.982|||||||t-test, 2 sided|||||||0.982
91573886|NCT04147858|183035513|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.190
91573887|NCT04147858|183035513|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
91573888|NCT04147858|183035514|SUPERIORITY|||||||0.097|||||||t-test, 2 sided|||||||0.097
91573889|NCT04147858|183035514|SUPERIORITY|||||||0.849|||||||t-test, 2 sided|||||||0.849
91573890|NCT04121897|183035525|OTHER|||||||0.024|||||||t-test, 2 sided|||||||0.024
91573891|NCT03375320|183035542|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
91573892|NCT03375320|183035542|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
91573893|NCT03375320|183035543|SUPERIORITY|||||||0.2438|||||||One-sided stratified log-rank|||||||0.2438
91573894|NCT03375320|183035543|SUPERIORITY|||||||0.4426|||||||One-sided stratified log-rank|||||||0.4426
91573895|NCT03375320|183035545|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
91573896|NCT03375320|183035545|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
91573897|NCT03358238|183035549|OTHER||Proportion|0.404|||||TWO_SIDED|95.0|0.264|0.557|||||Type of confidence interval = Clopper-Pearson|||0.557|0.264|
91573898|NCT03358238|183035550|SUPERIORITY||Difference in Average Proportions|0.0017||||0.99|TWO_SIDED|95.0|-0.1774|0.1807||Statistical significance was an alpha level of 0.05.|t-test, 2 sided|Two-sample t test. Degrees of freedom = 45.|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates of self-reporting between arms was zero.||0.1807|-0.1774|0.99
91573899|NCT03358238|183035551|SUPERIORITY||Risk Difference (RD)|-0.0189||||0.85|TWO_SIDED|95.0|-0.2215|0.1837||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|Two-sample t-test. Degrees of freedom = 45|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates to activity tracking between arms was zero.||0.1837|-0.2215|0.85
91573900|NCT03358238|183035552|OTHER||Proportion|0.5385|||||TWO_SIDED|95.0|0.3718|0.6991|||||Type of confidence interval = Clopper-Pearson|Estimating proportion of individuals with higher adherence rates for self-report over activity tracking among individuals with unequal adherence rates||0.6991|0.3718|
91573901|NCT03358238|183035552|SUPERIORITY|||||||0.0828|||||||Chi-squared|Degrees of freedom = 1||Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm.||||0.0828
91573902|NCT03358238|183035553|OTHER||Mean Difference (Net)|0.79||||0.2|TWO_SIDED|95.0|-0.42|1.99||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t-test. Degrees of freedom = 46.|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~One-sample t confidence intervals."|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~Null hypothesis was that the average change in total scores was zero."||1.99|-0.42|0.20
91573903|NCT03358238|183035554|OTHER||Mean Difference (Net)|0.89||||0.32|TWO_SIDED|95.0|-0.91|2.7||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t test. Degrees of freedom = 46|One-sample t confidence intervals|Null hypothesis was that average change in scores on the structured interview guide for the Hamilton rating scale for depression is zero.||2.70|-0.91|0.32
91573904|NCT02633397|183035555|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.19
91573905|NCT02633397|183035556|SUPERIORITY|||||||0.42|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.42
91573906|NCT02633397|183035557|SUPERIORITY|||||||0.52|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.52
91573907|NCT02633397|183035559|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.69|TWO_SIDED|90.0|-0.7|0.42|||ANCOVA|||ANCOVA model adjusted for clinic site||0.42|-0.70|0.69
91573908|NCT02633397|183035560|SUPERIORITY||Mean Difference (Final Values)|-39.51||||0.4|TWO_SIDED|90.0|-117.05|38.02|||ANCOVA|||ANCOVA model adjusted for clinic site||38.02|-117.05|0.40
91573909|NCT02633397|183035561|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.23|TWO_SIDED|90.0|-0.11|0.73|||Regression, Linear|||Linear regression model adjusted for clinic site||0.73|-0.11|0.23
91573910|NCT02633397|183035562|SUPERIORITY||Mean Difference (Final Values)|-0.08||||-0.8|TWO_SIDED|90.0|-0.62|0.46|||ANCOVA|||ANCOVA model adjusted for clinic site||0.46|-0.62|-0.80
91573911|NCT02633397|183035563|SUPERIORITY||Mean Difference (Final Values)|-6.96|||<|0.001|TWO_SIDED|90.0|-10.22|-3.69|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in MAP as a function of time, the interaction between time and study arm, and clinic site.||-3.69|-10.22|<0.001
91573912|NCT02633397|183035564|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.15|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|||ANCOVA model adjusted for clinic site||0.02|-0.31|0.15
91573913|NCT02633397|183035565|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.003|TWO_SIDED|90.0|-10.28|-3.12|||ANCOVA|||ANCOVA model adjusted for clinic site||-3.12|-10.28|0.003
91573914|NCT02633397|183035566|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|90.0|2.0|5.04|||ANCOVA|||ANCOVA model adjusted for clinic site||5.04|2.00|<0.001
91573915|NCT02633397|183035567|SUPERIORITY||Mean Difference (Final Values)|286.56||||0.51|TWO_SIDED|90.0|-429.86|1002.99|||Regression, Linear|||Linear regression model adjusted for clinic site||1002.99|-429.86|0.51
91573916|NCT02633397|183035568|SUPERIORITY||Mean Difference (Final Values)|-82.18||||0.14|TWO_SIDED|90.0|-173.69|9.32|||Regression, Linear|||Linear regression model adjusted for clinic site||9.32|-173.69|0.14
91573917|NCT02633397|183035569|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare microalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.78
91573918|NCT02633397|183035570|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare macroalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.30
91573919|NCT02633397|183035571|SUPERIORITY||Mean Difference (Final Values)|-4.91||||0.06|TWO_SIDED|90.0|-9.21|-0.62|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GFR as a function of time, the interaction between time and study arm, and clinic site.||-0.62|-9.21|0.06
91573920|NCT02633397|183035572|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare CKD stage frequency as a function of time and the interaction between time and study arm.||||0.56
91573921|NCT02633397|183035573|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.15|TWO_SIDED|90.0|-0.52|0.03|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in hemoglobin as a function of time, the interaction between time and study arm, and clinic site.||0.03|-0.52|0.15
91573922|NCT02633397|183035574|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.05|TWO_SIDED|90.0|0.22|2.72|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in reticulocyte count as a function of time, the interaction between time and study arm, and clinic site.||2.72|0.22|0.05
91573923|NCT02633397|183035575|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.75|TWO_SIDED|90.0|-0.93|0.63|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||0.63|-0.93|0.75
91573924|NCT02633397|183035576|SUPERIORITY||Mean Difference (Final Values)|-29.28||||0.17|TWO_SIDED|90.0|-64.63|6.08|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||6.08|-64.63|0.17
91573925|NCT02633397|183035577|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.07|TWO_SIDED|90.0|-3.13|-0.15|||Regression, Linear|||Linear regression model adjusted for clinic site||-0.15|-3.13|0.07
91573926|NCT03036124|183035581|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
91573927|NCT03036124|183035582|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
91573928|NCT03036124|183035583|SUPERIORITY||Rate Ratio (RR)|0.75||||0.0002||95.0|0.65|0.88|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.88|0.65|0.0002
91573929|NCT03036124|183035584|SUPERIORITY||Win Ratio (WR)|1.18|||<|0.0001||95.0|1.11|1.26||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in total symptom score at 8 months, or death before 8 months.|||1.26|1.11|<0.0001
91573930|NCT03036124|183035585|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.1681||95.0|0.44|1.16|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.||||1.16|0.44|0.1681
91573931|NCT03036124|183035586|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0217||95.0|0.71|0.97|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||||0.97|0.71|0.0217
91573932|NCT05101993|183035594|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
91573933|NCT04526665|183035608|OTHER||Odds Ratio (OR)|37.562|||<|0.0001|TWO_SIDED|95.0|7.641|302.247|||Exact Cochran-Mantel-Haenszel test|Exact Cochran-Mantel-Haenszel test stratified by the randomization factors (ALP \>3xULN or TB\>ULN:Yes/No, and Baseline PBC Worst Itch NRS ≥ 4: Yes/No)||||302.247|7.641|<0.0001
91573934|NCT04526665|183035610|OTHER||Least square mean difference|-0.784||||0.197|TWO_SIDED|95.0|-1.986|0.418|||mixed model for repeated measures (MMRM)|||||0.418|-1.986|0.1970
91573935|NCT04526665|183035611|OTHER||Least square mean difference|-0.343||||0.5522|TWO_SIDED|95.0|-1.489|0.803|||MMRM|MMRM with treatment, 4-week period and treatment by 4-week period interaction as fixed factors and adjusting for baseline and stratification factors.||||0.803|-1.489|0.5522
91573936|NCT01888874|183035690|SUPERIORITY||Difference in percentage rates|11.9||||0.1236|TWO_SIDED|95.0|-3.1|26.9|||Regression, Logistic|P-value has been corrected for multiplicity according to Hommel's closed-testing method.||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||26.9|-3.1|0.1236
91573937|NCT01888874|183035690|SUPERIORITY||Difference in percentage rates|19.3||||0.0435|TWO_SIDED|95.0|4.7|34.0||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||34|4.7|0.0435
91573938|NCT01888874|183035690|SUPERIORITY||Difference in percentage rates|24.4||||0.0068|TWO_SIDED|95.0|10.1|38.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||38.8|10.1|0.0068
91573939|NCT01888874|183035690|SUPERIORITY||Difference in percentage rates|12.8||||0.1236|TWO_SIDED|95.0|-2.0|27.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||27.6|-2|0.1236
91573940|NCT01888874|183035690|SUPERIORITY||Difference in percentage rates|15.8||||0.1056|TWO_SIDED|95.0|1.0|30.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||30.6|1|0.1056
91573941|NCT01888874|183035690|SUPERIORITY||Difference in percentage rates|34.4|||<|0.0001|TWO_SIDED|95.0|20.7|48.1||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||48.1|20.7|< 0.0001
91573942|NCT01020877|183035724|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test\[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.0|||||TWO_SIDED|90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
91573943|NCT01020877|183035725|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|98.2|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|98.2|
91573944|NCT01020877|183035726|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|97.6|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|97.6|
91573945|NCT00709228|183035734|SUPERIORITY_OR_OTHER||simple proportion|0.097|||||TWO_SIDED|95.0|0.06|0.15||||||||0.15|0.06|
91573946|NCT02179177|183035735|OTHER||Mean Difference (Net)|1.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
91573947|NCT01516749|183035751|SUPERIORITY_OR_OTHER|||||||0.024||||||significance was accepted at p\<0.05|t-test, 2 sided|||Significance of decrease in modified Sartorius score from Baseline to 8 weeks||||0.024
91573948|NCT01516749|183035752|SUPERIORITY_OR_OTHER|||||||0.006||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy||||0.006
91573949|NCT01516749|183035752|SUPERIORITY_OR_OTHER|||||||0.019||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy||||0.019
91573950|NCT02493946|183035805|SUPERIORITY||Treatment difference|80.8|||<|0.0001|TWO_SIDED|95.0|73.7|88.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders.||88.0|73.7|<0.0001
91573951|NCT02493946|183035806|SUPERIORITY||Treatment difference|75.0|||<|0.0001|TWO_SIDED|95.0|67.1|82.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||82.8|67.1|<0.0001
91573952|NCT02493946|183035806|SUPERIORITY||Treatment difference|74.1|||<|0.0001|TWO_SIDED|95.0|66.2|82.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||82.1|66.2|<0.0001
91573953|NCT02493946|183035806|SUPERIORITY||Treatment difference|53.6|||<|0.0001|TWO_SIDED|95.0|44.2|63.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||63.1|44.2|<0.0001
91573954|NCT02493946|183035808|SUPERIORITY||Treatment difference|58.0|||<|0.0001|TWO_SIDED|95.0|44.5|71.6||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||71.6|44.5|<0.0001
91573955|NCT02493946|183035808|SUPERIORITY||Treatment difference|56.8|||<|0.0001|TWO_SIDED|95.0|44.5|69.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||69.0|44.5|<0.0001
91573956|NCT02493946|183035808|SUPERIORITY||Treatment difference|62.5|||<|0.0001|TWO_SIDED|95.0|52.1|72.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||72.9|52.1|<0.0001
91573957|NCT02493946|183035808|SUPERIORITY||Treatment difference|42.6|||<|0.0001|TWO_SIDED|95.0|29.5|55.7||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||55.7|29.5|<0.0001
91573958|NCT02493946|183035809|SUPERIORITY||Treatment difference|61.1|||<|0.0001|TWO_SIDED|95.0|51.9|70.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||70.3|51.9|<0.0001
91573959|NCT02493946|183035809|SUPERIORITY||Treatment difference|65.8|||<|0.0001|TWO_SIDED|95.0|56.8|74.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||74.8|56.8|<0.0001
91573960|NCT02493946|183035809|SUPERIORITY||Treatment difference|70.5|||<|0.0001|TWO_SIDED|95.0|62.2|78.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||78.8|62.2|<0.0001
91573961|NCT02493946|183035809|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|24.0|42.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||42.0|24.0|<0.0001
91573962|NCT02493946|183035810|SUPERIORITY||Treatment difference|68.2|||<|0.0001|TWO_SIDED|95.0|58.2|78.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Linear|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||78.3|58.2|<0.0001
91573963|NCT02493946|183035810|SUPERIORITY||Treatment difference|77.4|||<|0.0001|TWO_SIDED|95.0|68.6|86.2||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||86.2|68.6|<0.0001
91573964|NCT02493946|183035810|SUPERIORITY||Treatment difference|74.4|||<|0.0001|TWO_SIDED|95.0|65.7|83.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||83.1|65.7|<0.0001
91573965|NCT02493946|183035810|SUPERIORITY||Treatment difference|51.0|||<|0.0001|TWO_SIDED|95.0|42.0|59.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||59.9|42.0|<0.0001
91573966|NCT02493946|183035811|SUPERIORITY||Hazard Ratio (HR)|15.296|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|The cox proportional hazard model used centre, gender and ILA baseline severity score as covariates.||Treatment difference in median time to onset of treatment response.||||<0.0001
91573967|NCT02493946|183035812|SUPERIORITY||Treatment difference|8.6|||<|0.0001|TWO_SIDED|95.0|5.2|12.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference ( BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||12.0|5.2|<0.0001
91573968|NCT02493946|183035812|SUPERIORITY||Treatment difference|11.1|||<|0.0001|TWO_SIDED|95.0|7.4|14.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||14.8|7.4|<0.0001
91573969|NCT02493946|183035812|SUPERIORITY||Treatment difference|10.4|||<|0.0001|TWO_SIDED|95.0|6.8|14.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||14.0|6.8|<0.0001
91573970|NCT02493946|183035812|SUPERIORITY||Treatment difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.9|13.3||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||13.3|5.9|<0.0001
91573971|NCT02493946|183035813|SUPERIORITY||Treatment difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.0|13.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||13.6|5.0|<0.0001
91573972|NCT02493946|183035813|SUPERIORITY||Treatment difference|11.4|||<|0.0001|TWO_SIDED|95.0|6.7|16.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||16.0|6.7|<0.0001
91573973|NCT02493946|183035813|SUPERIORITY||Treatment difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.4|15.9||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||15.9|6.4|<0.0001
91573974|NCT02493946|183035813|SUPERIORITY||Treatment difference|8.1||||0.0004|TWO_SIDED|95.0|3.7|12.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||12.6|3.7|0.0004
91573975|NCT02493946|183035814|SUPERIORITY||Treatment difference|-0.6||||0.0174|TWO_SIDED|95.0|-1.1|-0.1||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||-0.1|-1.1|0.0174
91573976|NCT02493946|183035814|SUPERIORITY||Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||-0.6|-1.7|<0.0001
91573977|NCT02493946|183035814|SUPERIORITY||Treatment difference|-1.4||||0.0001|TWO_SIDED|95.0|-2.0|-0.7||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||-0.7|-2.0|0.0001
91573978|NCT02493946|183035814|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||-0.8|-2.1|<0.0001
91573979|NCT00965497|183035823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|95.0||||0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.||||0.01
91573980|NCT03274895|183035862|NON_INFERIORITY|Non-inferiority margin= 0.20|difference in proportion of resolution r|-0.036|||||TWO_SIDED|95.0|-0.154|0.081||||||||0.081|-0.154|
91573981|NCT03274895|183035863|OTHER|||||||0.042|||||||Log Rank|||||||0.042
91573982|NCT03274895|183035864|OTHER|||||||0.577|||||||ANCOVA|||||||0.577
91573983|NCT01055704|183035870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.389||0.902|TWO_SIDED|95.0|-0.835|0.739|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.739|-0.835|0.902
91573984|NCT01055704|183035870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.351||0.709|TWO_SIDED|95.0|-0.578|0.841|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.841|-0.578|0.709
91573985|NCT01055704|183035871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.971|STANDARD_ERROR_OF_MEAN|4.669||0.675|TWO_SIDED|95.0|-11.415|7.472|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||7.472|-11.415|0.675
91573986|NCT01055704|183035871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|4.208||0.591|TWO_SIDED|95.0|-10.792|6.233|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||6.233|-10.792|0.591
91573987|NCT01055704|183035872|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-34.425|STANDARD_ERROR_OF_MEAN|14.67||0.024|TWO_SIDED|95.0|-64.097|-4.753|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||-4.753|-64.097|0.024
91573988|NCT01055704|183035872|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|13.24||0.989|TWO_SIDED|95.0|-26.962|26.598|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||26.598|-26.962|0.989
91573989|NCT01055704|183035873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|STANDARD_ERROR_OF_MEAN|0.211||0.064|TWO_SIDED|95.0|-0.827|0.025|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.025|-0.827|0.064
91573990|NCT01055704|183035873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.19||0.61|TWO_SIDED|95.0|-0.287|0.482|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.482|-0.287|0.610
91573991|NCT01055704|183035874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.728|STANDARD_ERROR_OF_MEAN|0.497||0.151|TWO_SIDED|95.0|-0.278|1.734|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.734|-0.278|0.151
91573992|NCT01055704|183035874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.448||0.806|TWO_SIDED|95.0|-0.795|1.017|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.017|-0.795|0.806
91573993|NCT01055704|183035875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.772|STANDARD_ERROR_OF_MEAN|12.583||0.889|TWO_SIDED|95.0|-23.678|27.223|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates||27.223|-23.678|0.889
91573994|NCT01055704|183035875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.607|STANDARD_ERROR_OF_MEAN|11.356||0.274|TWO_SIDED|95.0|-10.362|35.577|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||35.577|-10.362|0.274
91573995|NCT01055704|183035876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.178||0.236|TWO_SIDED|95.0|-0.572|0.145|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.145|-0.572|0.236
91573996|NCT01055704|183035876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.19||0.885|TWO_SIDED|95.0|-0.412|0.357|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.357|-0.412|0.885
91573997|NCT01055704|183035877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497|STANDARD_ERROR_OF_MEAN|0.374||0.192|TWO_SIDED|95.0|-1.255|0.261|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.261|-1.255|0.192
91573998|NCT01055704|183035877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.342||0.855|TWO_SIDED|95.0|-0.756|0.63|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.630|-0.756|0.855
91573999|NCT01814072|183035995|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
91574000|NCT01814072|183035996|SUPERIORITY||Estimated Change|0.1244||||0.567|TWO_SIDED|95.0|-0.3026|0.5513|||Mixed Models Analysis|||||.5513|-.3026|0.567
91574001|NCT01814072|183035996|SUPERIORITY||Estimated Change|-0.0226||||0.917|TWO_SIDED|95.0|-0.4495|0.4044|||Mixed Models Analysis|||||.4044|-.4495|0.917
91574002|NCT01814072|183035996|SUPERIORITY||Estimated Change|0.084||||0.699|TWO_SIDED|95.0|-0.3429|0.5109|||Mixed Models Analysis|||||.5109|-.3429|0.699
91574003|NCT01814072|183035996|SUPERIORITY||Estimated Change|0.1081||||0.619|TWO_SIDED|95.0|-0.3188|0.535|||Mixed Models Analysis|||||.5350|-.3188|0.619
91574004|NCT01814072|183035996|SUPERIORITY||Estimated Change|-0.4353||||0.046|TWO_SIDED|95.0|-0.8622|-0.0084|||Mixed Models Analysis|||||-.0084|-.8622|0.046
91574005|NCT01814072|183035997|OTHER||Estimated Change|0.424||||0.051|TWO_SIDED|95.0|-0.002|0.85|||Mixed Models Analysis|||Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.||0.850|-0.002|0.051
91574006|NCT02781311|183036004|SUPERIORITY||Least-squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|4.45||0.9239|TWO_SIDED|95.0|-8.38|9.23||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.|ANCOVA|||||9.23|-8.38|0.9239
91574007|NCT02781311|183036005|SUPERIORITY||Least-squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.42|0.37||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.|ANCOVA|||||0.37|-0.42|0.9101
91574008|NCT01936467|183036040|OTHER||Sensitivity|93.7|||||TWO_SIDED|||||||||||||
91574009|NCT01936467|183036040|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
91574010|NCT01936467|183036041|OTHER||Sensitivity|88.6|||||TWO_SIDED|||||||||||||
91574011|NCT01936467|183036041|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
91574012|NCT01936467|183036042|OTHER|||||||0.47|||||||Chi-squared|||||||0.47
91574013|NCT01936467|183036043|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
91574014|NCT01936467|183036044|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
91574015|NCT01936467|183036045|SUPERIORITY_OR_OTHER|||||||0.46|||||||Chi-squared|||||||0.46
91574016|NCT00250432|183036046|NON_INFERIORITY_OR_EQUIVALENCE|Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).|Rate Difference|1.1|STANDARD_ERROR_OF_MEAN|5.6||||95.0|-4.1|6.8|||||The confidence interval computation was based on the method by Miettinen and Nurminen.|A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.||6.8|-4.1|
91574017|NCT00250432|183036047|SUPERIORITY_OR_OTHER||Rate Difference|6.3|STANDARD_ERROR_OF_MEAN|12.1||||95.0|-5.9|18.4|||||The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.|There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.||18.4|-5.9|
91574018|NCT01011868|183036048|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.78|-0.33||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo~* H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo"||-0.33|-0.78|<0.0001
91574019|NCT01011868|183036048|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.93|-0.47||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo~* H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo"||-0.47|-0.93|<0.0001
91574020|NCT01011868|183036049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.518|||<|0.0001|TWO_SIDED|95.0|3.262|9.334|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c.||Empagliflozin 10 mg vs Placebo at 18 weeks||9.334|3.262|<0.0001
91574021|NCT01011868|183036049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.883|||<|0.0001|TWO_SIDED|95.0|2.859|8.338|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||8.338|2.859|<0.0001
91574022|NCT01011868|183036049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.471|||<|0.0001|TWO_SIDED|95.0|2.077|5.802|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||5.802|2.077|<0.0001
91574023|NCT01011868|183036049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.825|||<|0.0001|TWO_SIDED|95.0|2.268|6.451|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||6.451|2.268|<0.0001
91574024|NCT01011868|183036049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.802||||0.0002|TWO_SIDED|95.0|1.639|4.789|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.789|1.639|0.0002
91574025|NCT01011868|183036049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.527|||<|0.0001|TWO_SIDED|95.0|2.051|6.066|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.066|2.051|<0.0001
91574026|NCT01011868|183036050|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.4|STANDARD_ERROR_OF_MEAN|4.65|<|0.0001|TWO_SIDED|95.0|-37.54|-19.27|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-19.27|-37.54|<0.0001
91574027|NCT01011868|183036050|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.21|STANDARD_ERROR_OF_MEAN|4.81|<|0.0001|TWO_SIDED|95.0|-43.67|-24.76|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks||-24.76|-43.67|<0.0001
91574028|NCT01011868|183036050|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.75|STANDARD_ERROR_OF_MEAN|5.02||0.0328|TWO_SIDED|95.0|-20.62|-0.89|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks||-0.89|-20.62|0.0328
91574029|NCT01011868|183036050|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.16|STANDARD_ERROR_OF_MEAN|5.16||0.0002|TWO_SIDED|95.0|-29.31|-9.01|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-9.01|-29.31|0.0002
91574030|NCT01011868|183036050|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.03|STANDARD_ERROR_OF_MEAN|5.07||0.3216|TWO_SIDED|95.0|-15.01|4.94|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||4.94|-15.01|0.3216
91574031|NCT01011868|183036050|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.95|STANDARD_ERROR_OF_MEAN|5.23||0.0229|TWO_SIDED|95.0|-22.24|-1.67|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-1.67|-22.24|0.0229
91574032|NCT01011868|183036051|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.12|STANDARD_ERROR_OF_MEAN|5.22|<|0.0001|TWO_SIDED|95.0|-35.38|-14.86|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-14.86|-35.38|<0.0001
91574033|NCT01011868|183036051|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.01|||<|0.0001|TWO_SIDED|95.0|-41.62|-20.39|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||-20.39|-41.62|<0.0001
91574034|NCT01011868|183036051|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|5.15|<|0.0484|TWO_SIDED|95.0|-20.33|-0.07|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.07|-20.33|<0.0484
91574035|NCT01011868|183036051|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.42|STANDARD_ERROR_OF_MEAN|5.3||0.0003|TWO_SIDED|95.0|-29.84|-8.99|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-8.99|-29.84|0.0003
91574036|NCT01011868|183036051|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.73|STANDARD_ERROR_OF_MEAN|5.07||0.3517||95.0|-14.71|5.25|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||5.25|-14.71|0.3517
91574037|NCT01011868|183036051|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.39|STANDARD_ERROR_OF_MEAN|5.23||0.0185|TWO_SIDED|95.0|-22.69|-2.1|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-2.10|-22.69|0.0185
91574038|NCT01011868|183036052|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.58|STANDARD_ERROR_OF_MEAN|2.4||0.0213|TWO_SIDED|95.0|-10.32|-0.84|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.|Empagliflozin versus Placebo 10 mg at 54 weeks||-0.84|-10.32|0.0213
91574039|NCT01011868|183036052|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.69|STANDARD_ERROR_OF_MEAN|2.49||0.0237|TWO_SIDED|95.0|-10.62|-0.77|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Empagliflozin versus Placebo 25 mg at 54 weeks||-0.77|-10.62|0.0237
91574040|NCT01011868|183036052|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.18||0.0024|TWO_SIDED|97.5|-11.56|-1.77||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 10 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo"||-1.77|-11.56|0.0024
91574041|NCT01011868|183036052|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.92|STANDARD_ERROR_OF_MEAN|2.25||0.009|TWO_SIDED|97.5|-11.0|-0.85||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 25 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo"||-0.85|-11.00|0.0090
91574042|NCT01011868|183036053|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|0.95||0.032|TWO_SIDED|95.0|-3.9|-0.18|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-0.18|-3.90|0.0320
91574043|NCT01011868|183036053|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.99||0.3818|TWO_SIDED|95.0|-2.81|1.08|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||1.08|-2.81|0.3818
91574044|NCT01011868|183036053|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-2.89|-1.05|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-1.05|-2.89|<0.0001
91574045|NCT01011868|183036053|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.17|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-3.13|-1.22|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-1.22|-3.13|<0.0001
91574046|NCT01011868|183036053|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.63|STANDARD_ERROR_OF_MEAN|1.1||0.0012|TWO_SIDED|95.0|-5.81|-1.45|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||-1.45|-5.81|0.0012
91574047|NCT01011868|183036053|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.12|STANDARD_ERROR_OF_MEAN|1.15||0.0073|TWO_SIDED|95.0|-5.39|-0.85|||Mixed Models Analysis|Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects|Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-0.85|-5.39|0.0073
91574048|NCT01011868|183036055|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.68|-0.26|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.26|-0.68|<0.0001
91574049|NCT01011868|183036055|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.95|-0.52|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-0.52|-0.95|<0.0001
91574050|NCT01011868|183036055|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|97.5|-0.73|-0.19||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 10 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo \<0.3%"||-0.19|-0.73|0.0001
91574051|NCT01011868|183036055|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|97.5|-0.9|-0.34||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 25 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo \<0.3%"||-0.34|-0.90|<0.0001
91574052|NCT01011868|183036057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.096||||0.0005|TWO_SIDED|95.0|1.846|9.088|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 18 weeks||9.088|1.846|0.0005
91574053|NCT01011868|183036057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.636||||0.0002|TWO_SIDED|95.0|2.083|10.321|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||10.321|2.083|0.0002
91574054|NCT01011868|183036057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.1248|TWO_SIDED|95.0|0.856|3.575|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||3.575|0.856|0.1248
91574055|NCT01011868|183036057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.423||||0.0132|TWO_SIDED|95.0|1.203|4.879|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||4.879|1.203|0.0132
91574056|NCT01011868|183036057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.939||||0.0986|TWO_SIDED|95.0|0.884|4.256|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.256|0.884|0.0986
91574057|NCT01011868|183036057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.239||||0.0024|TWO_SIDED|95.0|1.518|6.911|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.911|1.518|0.0024
91574058|NCT02615938|183036058|SUPERIORITY|||||||1|||||||Fisher Exact|No estimated value can be calculated if in any group no responder exists (i.e. no odds exists for independent groups)||||||1
91574059|NCT02615938|183036058|OTHER|McNemar test for paired samples was not calculated as in any group no responder exists (i.e. no odds exists for independent groups or no discordant pairs could be determined for dependent groups).|||||||||||||||||No estimated OR value can be calculated if in any group no responder exists (i.e. no odds exists for independent groups) and no P values can be calculated as in any group no responder existed (i.e. no odds exists for independent groups or no disconcordant pairs could be determined for dependent groups)|||
91574060|NCT02615938|183036058|SUPERIORITY|||||||1|||||||Fisher Exact|No estimated value can be calculated if in any group no responder exists (i.e. no odds exists for independent groups)||||||1.0
91574061|NCT02615938|183036058|OTHER|McNemar test for paired samples was not calculated as in any group no responder exists (i.e. no odds exists for independent groups or no discordant pairs could be determined for dependent groups).|||||||||||||||||No estimated OR value can be calculated if in any group no responder exists (i.e. no odds exists for independent groups) and no P values can be calculated as in any group no responder existed (i.e. no odds exists for independent groups or no disconcordant pairs could be determined for dependent groups)|||
91574062|NCT02615938|183036059|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|1.1|0.079|15.16|||Fisher Exact|||||15.16|0.079|1.0
91574063|NCT02615938|183036059|SUPERIORITY||Odds Ratio (OR)|-0.2||||1|TWO_SIDED|95.0|-0.34|0.008|||McNemar|||||0.008|-0.340|1.0
91574064|NCT02615938|183036059|SUPERIORITY|||||||0.196|||||||Fisher Exact|No estimated value can be calculated if in any group no responder exists (i.e. no odds exists for independent groups)||||||0.196
91574065|NCT02615938|183036059|OTHER|McNemar test for paired samples was not calculated as in any group no responder exists (i.e. no odds exists for independent groups or no discordant pairs could be determined for dependent groups).|||||||||||||||||No estimated OR value can be calculated if in any group no responder exists (i.e. no odds exists for independent groups) and no P values can be calculated as in any group no responder existed (i.e. no odds exists for independent groups or no disconcordant pairs could be determined for dependent groups)|||
91574066|NCT02615938|183036060|SUPERIORITY||Mean Difference (Net)|-0.2||||0.757|TWO_SIDED|95.0|-1.2|0.8|||t-test, 2 sided|||||0.8|-1.2|0.757
91574067|NCT02615938|183036060|SUPERIORITY||Mean Difference (Net)|0.6||||0.229|TWO_SIDED|95.0|-0.2|1.1|||t-test, 2 sided|||||1.1|-0.2|0.229
91574068|NCT02615938|183036060|SUPERIORITY||Mean Difference (Net)|-1.2||||0.097|TWO_SIDED|95.0|-2.7|0.4|||t-test, 2 sided|||||0.4|-2.7|0.097
91574069|NCT02615938|183036060|SUPERIORITY||Mean Difference (Net)|-0.9||||0.427|TWO_SIDED|95.0|-2.5|0.8|||t-test, 2 sided|||||0.8|-2.5|0.427
91574070|NCT02615938|183036061|SUPERIORITY||Mean Difference (Net)|-0.2||||0.543|TWO_SIDED|95.0|-1.2|0.8|||t-test, 2 sided|||||0.8|-1.2|0.543
91574071|NCT02615938|183036061|SUPERIORITY||Mean Difference (Net)|-0.5||||0.421|TWO_SIDED|95.0|-1.2|0.3|||t-test, 2 sided|||||0.3|-1.2|0.421
91574072|NCT02615938|183036061|SUPERIORITY||Mean Difference (Net)|-0.4||||0.553|TWO_SIDED|95.0|-1.8|1.1|||t-test, 2 sided|||||1.1|-1.8|0.553
91574073|NCT02615938|183036061|SUPERIORITY||Mean Difference (Net)|-2.8||||0.102|TWO_SIDED|95.0|-5.0|-0.5|||t-test, 2 sided|||||-0.5|-5|0.1020
91574074|NCT02615938|183036062|SUPERIORITY||Mean Difference (Net)|-0.8||||0.178|TWO_SIDED|95.0|-2.4|0.9|||t-test, 2 sided|||||0.9|-2.4|0.178
91574075|NCT02615938|183036062|SUPERIORITY||Mean Difference (Net)|-1.3||||0.11|TWO_SIDED|95.0|-2.6|-0.1|||t-test, 2 sided|||||-0.1|-2.6|0.110
91574076|NCT02615938|183036062|SUPERIORITY||Mean Difference (Net)|1.6||||0.338|TWO_SIDED|95.0|-0.6|3.9|||t-test, 2 sided|||||3.9|-0.6|0.338
91574077|NCT02615938|183036062|SUPERIORITY||Mean Difference (Net)|-1.0||||0.3979|TWO_SIDED|95.0|-3.0|1.1|||t-test, 2 sided|||||1.1|-3|0.3979
91574078|NCT02615938|183036063|SUPERIORITY||Mean Difference (Net)|0.0||||0.965|TWO_SIDED|95.0|-1.6|1.6|||t-test, 2 sided|||||1.6|-1.6|0.965
91574079|NCT02615938|183036063|SUPERIORITY||Mean Difference (Net)|0.8||||0.374|TWO_SIDED|95.0|-0.4|1.9|||t-test, 2 sided|||||1.9|-0.4|0.374
91574080|NCT02615938|183036063|SUPERIORITY||Mean Difference (Net)|-2.6||||0.149|TWO_SIDED|95.0|-5.2|0.1|||t-test, 2 sided|||||0.1|-5.2|0.149
91574081|NCT02615938|183036063|SUPERIORITY||Mean Difference (Net)|2.6||||0.2963|TWO_SIDED|95.0|0.0|5.3|||t-test, 2 sided|||||5.3|0|0.2963
91574082|NCT02615938|183036064|SUPERIORITY||Mean Difference (Net)|-0.9||||0.024|TWO_SIDED|95.0|-1.9|0.0|||t-test, 2 sided|||||0|-1.9|0.024
91574083|NCT02615938|183036064|SUPERIORITY||Mean Difference (Net)|-0.9||||0.045|TWO_SIDED|95.0|-1.7|-0.1|||t-test, 2 sided|||||-0.1|-1.7|0.045
91574084|NCT02615938|183036064|SUPERIORITY||Mean Difference (Net)|0.5||||0.458|TWO_SIDED|95.0|-0.9|2.0|||t-test, 2 sided|||||2.0|-0.9|0.458
91574085|NCT02615938|183036064|SUPERIORITY||Mean Difference (Net)|-1.1||||0.4216|TWO_SIDED|95.0|-2.8|0.7|||t-test, 2 sided|||||0.7|-2.8|0.4216
91574086|NCT02615938|183036065|SUPERIORITY||Mean Difference (Net)|1.3||||0.063|TWO_SIDED|95.0|0.1|2.5|||t-test, 2 sided|||||2.5|0.1|0.063
91574087|NCT02615938|183036065|SUPERIORITY||Mean Difference (Net)|0.6||||0.41|TWO_SIDED|95.0|-0.3|1.6|||t-test, 2 sided|||||1.6|-0.3|0.410
91574088|NCT02615938|183036065|SUPERIORITY||Mean Difference (Net)|-0.5||||0.574|TWO_SIDED|95.0|-2.3|1.3|||t-test, 2 sided|||||1.3|-2.3|0.574
91574089|NCT02615938|183036066|SUPERIORITY||Mean Difference (Net)|0.3||||0.73|TWO_SIDED|95.0|-0.9|1.5|||t-test, 2 sided|||||1.5|-0.9|0.730
91574090|NCT02615938|183036066|SUPERIORITY||Mean Difference (Net)|0.7||||0.17|TWO_SIDED|95.0|-0.3|1.8|||t-test, 2 sided|||||1.8|-0.3|0.170
91574091|NCT02615938|183036066|SUPERIORITY||Mean Difference (Net)|-0.3||||0.724|TWO_SIDED|95.0|-2.1|1.5|||t-test, 2 sided|||||1.5|-2.1|0.724
91574092|NCT02615938|183036066|SUPERIORITY||Mean Difference (Net)|-0.6||||0.487|TWO_SIDED|95.0|-2.2|1.1|||t-test, 2 sided|||||1.1|-2.2|0.487
91574093|NCT02615938|183036067|SUPERIORITY||Mean Difference (Net)|0.2||||0.85|TWO_SIDED|95.0|-1.0|1.4|||t-test, 2 sided|||||1.4|-1|0.850
91574094|NCT02615938|183036067|SUPERIORITY||Mean Difference (Net)|0.6||||0.258|TWO_SIDED|95.0|-0.4|1.6|||t-test, 2 sided|||||1.6|-0.4|0.258
91574095|NCT02615938|183036067|SUPERIORITY||Mean Difference (Net)|-0.1||||0.862|TWO_SIDED|95.0|-1.9|1.7|||t-test, 2 sided|||||1.7|-1.9|0.862
91574096|NCT02615938|183036067|SUPERIORITY||Mean Difference (Net)|-0.2||||0.84|TWO_SIDED|95.0|-1.8|1.4|||t-test, 2 sided|||||1.4|-1.8|0.840
91574097|NCT02615938|183036068|SUPERIORITY||Mean Difference (Net)|-1.3||||0.01|TWO_SIDED|95.0|-2.6|0.0|||t-test, 2 sided|||||0|-2.6|0.010
91574098|NCT02615938|183036068|SUPERIORITY||Mean Difference (Net)|-0.5||||0.533|TWO_SIDED|95.0|-1.5|0.5|||t-test, 2 sided|||||0.5|-1.5|0.533
91574099|NCT02615938|183036068|SUPERIORITY||Mean Difference (Net)|0.1||||0.858|TWO_SIDED|95.0|-1.6|1.9|||t-test, 2 sided|||||1.9|-1.6|0.858
91574100|NCT02615938|183036068|SUPERIORITY||Mean Difference (Net)|0.2||||0.661|TWO_SIDED|95.0|-1.4|1.8|||t-test, 2 sided|||||1.8|-1.4|0.661
91574101|NCT02615938|183036069|SUPERIORITY|Due to missing values no statistical test resulting in a P was calculated|Mean Difference (Net)|-8.4|||||TWO_SIDED|95.0|-14.0|-2.7||||||||-2.7|-14|
91574102|NCT02615938|183036069|SUPERIORITY||Mean Difference (Net)|0.5||||0.576|TWO_SIDED|95.0|-0.9|2.0|||t-test, 2 sided|||||2|-0.9|0.576
91574103|NCT02615938|183036069|SUPERIORITY||Mean Difference (Net)|-0.1||||0.884|TWO_SIDED|95.0|-1.9|1.7|||t-test, 2 sided|||||1.7|-1.9|0.884
91574104|NCT02615938|183036069|SUPERIORITY||Mean Difference (Net)|0.8||||0.563|TWO_SIDED|95.0|-2.4|0.9|||t-test, 2 sided|||||0.9|-2.4|0.563
91574105|NCT04683510|183036080|SUPERIORITY||Odds Ratio (OR)|1.647||||0.2345|TWO_SIDED|95.0|0.724|3.746|||Regression, Logistic|||||3.746|0.724|0.2345
91574106|NCT04683510|183036080|SUPERIORITY||Odds Ratio (OR)|1.897||||0.124|TWO_SIDED|95.0|0.839|4.291|||Regression, Logistic|||||4.291|0.839|0.124
91574107|NCT04683510|183036081|SUPERIORITY||Odds Ratio (OR)|0.905||||0.2352|TWO_SIDED|95.0|0.768|1.067|||Regression, Logistic|||||1.067|0.768|0.2352
91574108|NCT04683510|183036081|SUPERIORITY||Odds Ratio (OR)|0.924||||0.3418|TWO_SIDED|95.0|0.785|1.088|||Regression, Logistic|||||1.088|0.785|0.3418
91574109|NCT04683510|183036082|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1653|TWO_SIDED|95.0|0.921|1.615|||Regression, Logistic|||||1.615|0.921|0.1653
91574110|NCT04683510|183036082|SUPERIORITY||Odds Ratio (OR)|1.213||||0.181|TWO_SIDED|95.0|0.914|1.609|||Regression, Logistic|||||1.609|0.914|0.181
91574111|NCT03771638|183036083|SUPERIORITY|Minimum detectable effects: Under assumptions of the adherence of DBS TFV-DP levels \>=700 fmol/punch in the control condition as 60% and intraclass correlation of repeated binary measures of DBS TFV-DP of 0.69, and retention of 80% of participants at 24 weeks, we will have 80% power in 2-sided tests with a type-1 error rate of 5% to detect average between-group differences in adherence of 23 percentage points.|Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.75|1.36||GEE poisson models with robust standard errors were used to assess DBS adherence rates, averaged across visits.|GEE Poisson models|||Null hypothesis: no difference in PrEP adherence levels between DOT Diary Intervention and Control arms||1.36|0.75|0.94
91574112|NCT03771638|183036084|OTHER||Kappa statistic|0.49|||||TWO_SIDED|95.0|0.36|0.62|||Kappa|||Kappa statistic to assess concordance between DBS measurement and self-reported PrEP use||0.62|0.36|
91574113|NCT02353312|183036088|EQUIVALENCE|Pairwise comparisons of VO2 max means with equal variances between participant on and off treatment.||||||0.823|||||||t-test, 2 sided|||||||0.823
91574114|NCT01151423|183036141|SUPERIORITY||Hazard Ratio (HR)|2.2|||=|0.005|TWO_SIDED|95.0|1.28|3.78||Caplacizumab was compared to placebo using a one-sided log-rank test in order to assess superiority at 2.5% significance level.|Stratified log-rank test||The HR was estimated from a Cox proportional Hazards regression model with presence (yes) / absence (no) of 1 PE session prior to randomization as covariate.|The primary analysis consisted of a Kaplan-Meier analysis with time-to-response as endpoint and treatment group as the independent variable and stratified for absence/presence of one PE session prior to randomization.||3.78|1.28|= 0.005
91574115|NCT01227616|183036169|NON_INFERIORITY|The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non-inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.|Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED||||||ANCOVA|Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.||||||<0.05
91574116|NCT02065882|183036431|OTHER|Confirmatory t-test testing of the MCF difference (1 h post-dose minus pre-dose)|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91574117|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (CI) of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
91574118|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.07||||||Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.07|-1.14|
91574119|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.08||||||Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.08|-1.14|
91574120|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
91574121|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.15|2.09||||||Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.09|-1.15|
91574122|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
91574123|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.56|||||TWO_SIDED|95.0|-3.93|2.69||||||Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.69|-3.93|
91574124|NCT01411241|183036447|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.36|||||TWO_SIDED|95.0|-4.87|4.06||||||Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||4.06|-4.87|
91574125|NCT04052425|183036461|SUPERIORITY||Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.341|11.903||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||11.903|2.341|< 0.0001
91574126|NCT04052425|183036462|SUPERIORITY||Odds Ratio (OR)|5.18|||<|0.0001|TWO_SIDED|95.0|2.831|9.482||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.482|2.831|< 0.0001
91574127|NCT04052425|183036463|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0038|TWO_SIDED|95.0|1.997|36.048||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||36.048|1.997|0.0038
91574128|NCT04052425|183036464|SUPERIORITY||Odds Ratio (OR)|4.93||||0.002|TWO_SIDED|95.0|1.795|13.566||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||13.566|1.795|0.0020
91574129|NCT04052425|183036465|SUPERIORITY||Odds Ratio (OR)|9.53||||0.0002|TWO_SIDED|95.0|2.9|31.29||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||31.290|2.900|0.0002
91574130|NCT04052425|183036466|SUPERIORITY||least squares mean difference|-19.3|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-27.05|-11.64||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-11.64|-27.05|< 0.0001
91574131|NCT04052425|183036469|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.0001|TWO_SIDED|95.0|3.226|9.578||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.578|3.226|< 0.0001
91574132|NCT04052425|183036471|SUPERIORITY||least squares mean difference|-30.61|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|-39.03|-22.19|||mixed-effect model; repeated measurement|||||-22.19|-39.03|<0.0001
91574133|NCT04052425|183036474|SUPERIORITY||least squares mean difference|-16.98|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001|TWO_SIDED|95.0|-23.28|-10.68|||mixed-effect model; repeated measurement|||||-10.68|-23.28|<0.0001
91574134|NCT04052425|183036476|SUPERIORITY||least squares mean difference|-9.07|STANDARD_ERROR_OF_MEAN|2.49||0.0003|TWO_SIDED|95.0|-13.96|-4.18|||mixed-effect model; repeated measurement|||||-4.18|-13.96|0.0003
91574135|NCT04052425|183036478|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.746|5.307||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||5.307|1.746|< 0.0001
91574136|NCT04052425|183036478|SUPERIORITY||Odds Ratio (OR)|2.3||||0.2921|TWO_SIDED|95.0|0.489|10.823||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||10.823|0.489|0.2921
91574137|NCT04052425|183036478|SUPERIORITY||Odds Ratio (OR)|0.49||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
91574138|NCT04052425|183036481|SUPERIORITY||least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.497|TWO_SIDED|95.0|-1.26|0.62|||mixed-effect model; repeated measurement|||||0.62|-1.26|0.4970
91574139|NCT01189110|183036485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|STANDARD_ERROR_OF_MEAN|0.42||0.74|TWO_SIDED|95.0|0.23|2.83|||Chi-squared|||A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.||2.83|0.23|0.74
91574140|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|3.959||0.9779|TWO_SIDED|90.0|-6.49|6.71|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.71|-6.49|0.9779
91574141|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|3.815||0.8801|TWO_SIDED|90.0|-5.79|6.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.94|-5.79|0.8801
91574142|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|3.845||0.9412|TWO_SIDED|90.0|-6.13|6.7|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.70|-6.13|0.9412
91574143|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|4.223||0.7486|TWO_SIDED|90.0|-8.38|5.66|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||5.66|-8.38|0.7486
91574144|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|8.18|STANDARD_ERROR_OF_MEAN|4.171||0.0534|TWO_SIDED|90.0|1.24|15.12|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.12|1.24|0.0534
91574145|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|3.776||0.998|TWO_SIDED|90.0|-6.29|6.31|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.31|-6.29|0.9980
91574146|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|3.35|STANDARD_ERROR_OF_MEAN|3.958||0.4004|TWO_SIDED|90.0|-3.25|9.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||9.94|-3.25|0.4004
91574147|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|4.214||0.6685|TWO_SIDED|90.0|-5.2|8.82|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||8.82|-5.20|0.6685
91574148|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|4.522||0.2968|TWO_SIDED|90.0|-2.77|12.25|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.25|-2.77|0.2968
91574149|NCT00945672|183036536|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|4.494||0.772|TWO_SIDED|90.0|-8.77|6.16|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.16|-8.77|0.7720
91574150|NCT00945672|183036537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.789||0.8205|TWO_SIDED|90.0|-12.68|16.69|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||16.69|-12.68|0.8205
91574151|NCT00945672|183036537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.37|STANDARD_ERROR_OF_MEAN|8.789||0.2007|TWO_SIDED|90.0|-3.31|26.06|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||26.06|-3.31|0.2007
91574152|NCT00945672|183036537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|8.9|STANDARD_ERROR_OF_MEAN|0.8789||0.3152|TWO_SIDED|90.0|-5.78|23.59|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||23.59|-5.78|0.3152
91574153|NCT00945672|183036537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|8.964||0.8071|TWO_SIDED|90.0|-17.18|12.79|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.79|-17.18|0.8071
91574154|NCT00945672|183036537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|9.354||0.9918|TWO_SIDED|90.0|-15.72|15.52|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.52|-15.72|0.9918
91574155|NCT00945672|183036537|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|9.415||0.7498|TWO_SIDED|90.0|-18.73|12.7|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.70|-18.73|0.7498
91574156|NCT00945672|183036538|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|1.91||0.4855|TWO_SIDED|90.0|-1.9|4.6|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||4.60|-1.90|0.4855
91574157|NCT00945672|183036538|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.185||0.5132|TWO_SIDED|90.0|-2.27|5.16|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||5.16|-2.27|0.5132
91574158|NCT01150461|183036547|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.02
91574159|NCT01150461|183036548|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.06
91574160|NCT01681992|183036549|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-5.48|||||TWO_SIDED|97.5|-7.65|-3.43|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-3.43|-7.65|
91574161|NCT01681992|183036549|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-2.08|||||TWO_SIDED|97.5|-3.96|-0.27|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-0.27|-3.96|
91574162|NCT01681992|183036550|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.42|||||TWO_SIDED|97.5|-1.91|1.04|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||1.04|-1.91|
91574163|NCT01681992|183036550|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.58|||||TWO_SIDED|97.5|-2.11|0.91|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||0.91|-2.11|
91574164|NCT01681992|183036551|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-9.41|||||TWO_SIDED|97.5|-13.2|-5.62|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-5.62|-13.20|
91574165|NCT01681992|183036551|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-7.22|||||TWO_SIDED|97.5|-10.94|-3.49|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-3.49|-10.94|
91574166|NCT01681992|183036552|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.71|||||TWO_SIDED|97.5|-3.11|-0.42|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||-0.42|-3.11|
91574167|NCT01681992|183036552|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.18|||||TWO_SIDED|97.5|-2.5|0.05|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||0.05|-2.50|
91574168|NCT01681992|183036553|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.79|||||TWO_SIDED|97.5|0.72|0.88|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||0.88|0.72|
91574169|NCT01681992|183036553|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.01|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||1.01|0.83|
91574170|NCT01681992|183036554|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.82|||||TWO_SIDED|97.5|0.76|0.89|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.89|0.76|
91574171|NCT01681992|183036554|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.84|||||TWO_SIDED|97.5|0.78|0.91|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.91|0.78|
91574172|NCT01681992|183036555|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.6|||||TWO_SIDED|97.5|0.53|0.68|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.68|0.53|
91574173|NCT01681992|183036555|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.65|||||TWO_SIDED|97.5|0.57|0.74|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.74|0.57|
91574174|NCT01681992|183036556|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.89|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
91574175|NCT01681992|183036556|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.88|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
91574176|NCT00447590|183036576|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided Exact Binomial Test|||p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.||||<0.0001
91574177|NCT04148989|183036588|SUPERIORITY||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-18.6|-7.0|||Regression, gamma||Change in emergency department door-to-antibiotic time (minutes) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||-7.0|-18.6|<0.001
91574178|NCT04148989|183036589|SUPERIORITY||Odds Ratio (OR)|0.89||||0.45|TWO_SIDED|95.0|0.68|1.19|||Regression, Logistic||Change in all-cause 30-day mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.19|0.68|0.45
91574179|NCT04148989|183036590|SUPERIORITY||Odds Ratio (OR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Logistic||Change in all-cause 1-year mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.04|0.67|0.10
91574180|NCT04148989|183036591|SUPERIORITY||Odds Ratio (OR)|0.77||||0.15|TWO_SIDED|95.0|0.53|1.1|||Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Change in all-cause in-hospital mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|1.10|0.53|0.15
91574181|NCT04148989|183036592|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.71|TWO_SIDED|95.0|-1.4|2.1|||Regression, gamma||Change in hospital charges ($1000s) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.1|-1.4|0.71
91574182|NCT04148989|183036593|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.19|TWO_SIDED|95.0|-0.4|0.1|||Regression, gamma||Change in hospital length of stay (days) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.1|-0.4|0.19
91574183|NCT04148989|183036594|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.1||||0.005|TWO_SIDED|95.0|1.03|1.17||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic||Change in antimicrobial treatment risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.17|1.03|0.005
91574184|NCT04148989|183036595|SUPERIORITY||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.68|1.75|||Regression, Logistic||Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.75|0.68|0.73
91574185|NCT04148989|183036596|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.78|1.33||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.|Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|1.33|0.78|0.90
91574186|NCT04148989|183036597|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.49|2.17|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.17|0.49|0.94
91574187|NCT04148989|183036598|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.14|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||2.14|0.93|0.10
91574188|NCT04148989|183036599|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.1% of eligible patients.|Odds Ratio (OR)|1.15||||0.59|TWO_SIDED|95.0|0.69|1.93|||Regression, Logistic||Change in risk for antimicrobial administration in the ED associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.93|0.69|0.59
91574189|NCT04148989|183036600|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.02|TWO_SIDED|95.0|0.06|0.58|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable ??? regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.58|0.06|0.02
91574190|NCT04148989|183036601|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 2.0% of eligible patients.|Mean Difference (Final Values)|0.17||||0.02|TWO_SIDED|95.0|0.03|0.31|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable linear regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||0.31|0.03|0.02
91574191|NCT03812029|183036602|SUPERIORITY|||||||0.0015||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0015
91574192|NCT03812029|183036602|SUPERIORITY|||||||0.0121||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0121
91574193|NCT03812029|183036602|SUPERIORITY|||||||0.0371||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0371
91574194|NCT03812029|183036603|SUPERIORITY|||||||0.003||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.003
91574195|NCT03812029|183036603|SUPERIORITY|||||||0.04||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.04
91574196|NCT03812029|183036604|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0017
91574197|NCT03812029|183036604|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
91574198|NCT03812029|183036604|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.13
91574199|NCT03812029|183036605|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.001
91574200|NCT03812029|183036605|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.002
91574201|NCT03812029|183036605|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
91574202|NCT03812029|183036606|SUPERIORITY|||||||0.09||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.09
91574203|NCT03812029|183036606|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.47
91574204|NCT03812029|183036606|SUPERIORITY|||||||0.14||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.14
91574205|NCT03812029|183036607|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
91574206|NCT03812029|183036607|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
91574207|NCT03812029|183036607|SUPERIORITY|||||||0.0002||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0002
91574208|NCT03812029|183036608|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.017
91574209|NCT03812029|183036608|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0006
91574210|NCT03812029|183036608|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.006
91574211|NCT03812029|183036609|SUPERIORITY|||||||0.16||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.16
91574212|NCT03812029|183036609|SUPERIORITY|||||||0.01||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.01
91574213|NCT03812029|183036609|SUPERIORITY|||||||0.57||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.57
91574214|NCT03812029|183036610|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0017
91574215|NCT03812029|183036610|SUPERIORITY|||||||0.0093||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0093
91574216|NCT01080300|183036617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.311||0.0003|TWO_SIDED|95.0|-2.31|-1.09||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Eltereen|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 4."||-1.09|-2.31|0.0003
91574217|NCT01080300|183036617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.335||0.1|TWO_SIDED|95.0|-1.8|-0.48||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12."||-0.48|-1.80|0.1000
91574218|NCT01080300|183036618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.31|-0.1||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 4."||-0.10|-0.31|<0.0001
91574219|NCT01080300|183036618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.072||0.0004|TWO_SIDED|95.0|-0.33|-0.04||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 12."||-0.04|-0.33|0.0004
91574220|NCT01080300|183036619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|0.453||0.151|TWO_SIDED|95.0|-1.98|-0.19|||Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily number of moderate to severe hot flashes at Week 24."||-0.19|-1.98|0.1510
91574221|NCT01080300|183036620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0004|TWO_SIDED|95.0|-0.44|0.0|||Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily severity score of moderate to severe hot flashes at Week 24."||-0.00|-0.44|0.0004
91574222|NCT01080300|183036621|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.6||||0.0008|TWO_SIDED|95.0|5.7|21.6|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the PGIC score at week 12.."||21.6|5.7|0.0008
91574223|NCT01080300|183036621|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||0.0009|TWO_SIDED|95.0|5.5|21.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 24."||21.3|5.5|0.0009
91574224|NCT01080300|183036622|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4|||<|0.0001|TWO_SIDED|95.0|8.4|24.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the CGIC score at week 12."||24.3|8.4|<0.0001
91574225|NCT01080300|183036622|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.007|TWO_SIDED|95.0|3.0|19.0|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||19.0|3.0|0.0070
91574226|NCT01080300|183036623|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.5||||0.0609|TWO_SIDED|95.0|-0.3|15.2|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||15.2|-0.3|0.0609
91574227|NCT01080300|183036623|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.3||||0.072|TWO_SIDED|95.0|-0.7|15.3|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||15.3|-0.7|0.0720
91574228|NCT01080300|183036624|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.1825|TWO_SIDED|95.0|-1.8|9.4|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||9.4|-1.8|0.1825
91574229|NCT01080300|183036624|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.4||||0.1662|TWO_SIDED|95.0|-1.8|10.7|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||10.7|-1.8|0.1662
91574230|NCT01080300|183036625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.75|-0.97||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily sleep interference rating.||-0.97|-1.75|<0.0001
91574231|NCT01080300|183036625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|-1.36|-0.47||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily sleep interference rating.||-0.47|-1.36|<0.0001
91574232|NCT01080300|183036625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-1.42|-0.49||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily sleep interference rating.||-0.49|-1.42|<0.0001
91574233|NCT01080300|183036626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.62|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-3.67|-1.56||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily insomnia severity index (ISI) rating.||-1.56|-3.67|<0.0001
91574234|NCT01080300|183036626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.543||0.0007|TWO_SIDED|95.0|-2.92|-0.78||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily insomnia severity index (ISI) rating.||-0.78|-2.92|0.0007
91574235|NCT01080300|183036626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|0.548||0.0014|TWO_SIDED|95.0|-2.84|-0.69|||ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily insomnia severity index (ISI) rating.||-0.69|-2.84|0.0014
91574236|NCT01080300|183036627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.084||0.0137|TWO_SIDED|95.0|-0.37|-0.04||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 4||-0.04|-0.37|0.0137
91574237|NCT01080300|183036627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.084||0.0872|TWO_SIDED|95.0|-0.31|0.02||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 12||0.02|-0.31|0.0872
91574238|NCT01080300|183036627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.091||0.5607|TWO_SIDED|95.0|-0.23|0.13||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 24||0.13|-0.23|0.5607
91574239|NCT02269423|183036651|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
91574240|NCT02269423|183036651|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
91574241|NCT02269423|183036651|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
91574242|NCT02269423|183036651|OTHER|||||||0.161||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.161
91574243|NCT02269423|183036651|OTHER|||||||0.008||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.008
91574244|NCT02269423|183036651|OTHER|||||||0.173||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.173
91574245|NCT02269423|183036652|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
91574246|NCT02269423|183036652|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
91574247|NCT02269423|183036652|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
91574248|NCT02269423|183036652|OTHER|||||||0.102||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.102
91574249|NCT02269423|183036652|OTHER|||||||0.124||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.124
91574250|NCT02269423|183036652|OTHER|||||||0.918||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.918
91574251|NCT01782690|183036706|SUPERIORITY_OR_OTHER|||||||0.2361|||||||Log Rank|||Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm||||0.2361
91574252|NCT01637077|183036728|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
91574253|NCT01637077|183036729|SUPERIORITY|||||||0.48|||||||Kruskal-Wallis|||||||0.48
91574254|NCT01637077|183036730|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Worst pain over the past 24 hours||||0.62
91574255|NCT01637077|183036730|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||Average pain over the past 24 hours||||0.22
91574256|NCT01637077|183036730|SUPERIORITY|||||||0.07|||||||Kruskal-Wallis|||Least pain over the past 24 hours||||0.07
91574257|NCT01637077|183036732|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
91574258|NCT01637077|183036733|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
91574259|NCT01637077|183036734|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
91574260|NCT01637077|183036735|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||0.12
91574261|NCT01637077|183036736|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||0.78
91574262|NCT01637077|183036737|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
91574263|NCT01637077|183036738|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Sensory neuropathy||||0.46
91574264|NCT01637077|183036738|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||Autonomic neuropathy||||0.86
91574265|NCT01637077|183036738|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Motor neuropathy||||0.40
91574266|NCT03023423|183036752|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.03|1.92||||||||1.92|0.03|
91574267|NCT05723263|183036806|OTHER||Proportional difference|94.5|||<|0.001|TWO_SIDED|95.0|94.2|94.8||The threshold for statistical significance was p\<0.05.|Generalized Estimating Equations|||It was calculated that 12 clinic sites with 1200 participants randomized in a 1:1:1 ratio between the three arms would have at least 90% power to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control group participants, using a two-sided, two-sample t-test (α=0.05), assuming a 0.25\~0.31 cluster coefficient of variation, a \<5% lost-to-follow-up rate, and an intra-class correlation of 0.016.||94.8|94.2|<0.001
91574268|NCT05723263|183036806|OTHER||Proportional difference|87.2|||<|0.001|TWO_SIDED|95.0|86.5|88.0||The threshold for statistical significance was p\<0.05.|Generalized Estimating Equations|||It was estimated that 12 clinic sites with 1200 participants randomized in a 1:1:1 ratio between the three arms would have at least 90% power to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control group participants, using a two-sided, two-sample t-test (α=0.05), assuming a 0.25\~0.31 cluster coefficient of variation, a \<5% lost-to-follow-up rate, and an intra-class correlation of 0.016.||88.0|86.5|<0.001
91574269|NCT05723263|183036806|OTHER||Proportional difference|7.3|||>|0.05|TWO_SIDED|95.0|6.6|7.9|||Generalized Estimating Equations|||Using a binary outcome and cluster RCT design, we estimated that 12 clinic clusters (two per city) and 1200 participants (100 per cluster) were needed to achieve a 90% power and allow for a 0.05 type-I error to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control arm participants and a \<5% lost-to-follow-up rate. We anticipated a test uptake of 65% in the community-engaged pay-it-forward arm, 45% in the standard pay-it-forward arm, and 20% in control.||7.9|6.6|>0.05
91574270|NCT05723263|183036807|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91574271|NCT05723263|183036808|OTHER|||||||0.0059|||||||Chi-squared|||||||0.0059
91574272|NCT05723263|183036809|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
91574273|NCT05723263|183036811|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91574274|NCT05723263|183036812|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
91574275|NCT05723263|183036813|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91574276|NCT05723263|183036814|OTHER|||||||0.727|||||||t-test, 2 sided|||||||0.727
91574277|NCT05723263|183036815|OTHER||Difference in Probability Difference|-0.047||||0.005|TWO_SIDED|95.0|-0.08|-0.014|||Generalized Estimating Equations||Absolute proportional difference in gonorrhea and chlamydia test uptake rate among community-led clinic participants across the three intervention arms|We anticipated a test uptake of 65% in the community-engaged pay-it-forward arm, 45% in the standard pay-it-forward arm, and 20% in the control between community-led and public STI clinic participants.||-0.014|-0.080|0.005
91574278|NCT05723263|183036816|OTHER||Difference in Probability Difference|-0.04||||0.015||95.0|-0.073|-0.008|||Generalized Estimating Equations|||We anticipated a test uptake of 65% in the community-engaged pay-it-forward arm, 45% in the standard pay-it-forward arm, and 20% in the control among MSM and non-MSM participants.||-0.008|-0.073|0.015
91574279|NCT05723263|183036817|OTHER||Difference in Probability Difference|0.015||||0.384||95.0|-0.019|0.049|||Generalized Estimating Equations|||We anticipated a test uptake of 65% in the community-engaged pay-it-forward arm, 45% in the standard pay-it-forward arm, and 20% in the control among participants 30 years and below and those above 30 years.||0.049|-0.019|0.384
91574280|NCT03974022|183036833|SUPERIORITY||||||<|0.0001|||||||binomial exact test against H0|||||||<0.0001
91574281|NCT03974022|183036833|SUPERIORITY||||||<|0.0001|||||||binomial exact test against H0|||||||<0.0001
91574282|NCT03811002|183036850|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5819|TWO_SIDED|95.0|0.82|1.34|||Log Rank|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). 1-sided significance level 0.025.|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|Assuming exponentially distributed survival times, 480 eligible patients accrued uniformly over 48 months months) with 26 months additional follow-up after the last accrued patient would provide at least 85% power to detect a hazard ratio of 0.71 (median survival times of 38 months \[Arm I\] vs. 27 months \[Arm II\]) at a one-sided significance level of 0.025, after adjusting for type 1 error using group sequential methods for two interim analyses.||1.34|0.82|0.5819
91574283|NCT03811002|183036851|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||Log Rank||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.21|0.80|
91574284|NCT03811002|183036854|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Cause-specific hazard ratio stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.41|0.52|
91574285|NCT03811002|183036855|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm I.|||1.20|0.76|
91574286|NCT05032066|183036874|SUPERIORITY||Least Squares (LS) Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.46||0.4388|TWO_SIDED|90.0|-3.56|1.29|||Mixed Model for Repeated Measures (MMRM)|||The primary analysis was based on a mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model using observed change in FVC % predicted values from all planned post-baseline assessments (Weeks 4, 16, 28, 40 and 52) with covariates of treatment group (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), prior use of IPF therapy \[yes or no\], FVC% predicted at baseline \[≥ 70, \<70\], visit week, and treatment by visit week interaction.||1.29|-3.56|0.4388
91574287|NCT05032066|183036874|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|1.493||0.7959|TWO_SIDED|90.0|-2.86|2.09|||MMRM|||The primary analysis was based on a mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model using observed change in FVC % predicted values from all planned post-baseline assessments (Weeks 4, 16, 28, 40 and 52) with covariates of treatment group (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), prior use of IPF therapy \[yes or no\], FVC% predicted at baseline \[≥ 70, \<70\], visit week, and treatment by visit week interaction.||2.09|-2.86|0.7959
91574288|NCT05032066|183036876|SUPERIORITY||Odds Ratio (OR)|0.854||||0.7179|TWO_SIDED|90.0|0.417|1.75|||Stratified logistic regression|||The percentage of participants with a decrease in FVC% predicted ≥10% from baseline at Week 52 were analyzed with observed data using a stratified logistic regression model. Baseline value and treatment were considered as factors in the model and prior use of approved IPF therapy \[yes or no\], FVC% predicted at baseline \[≥ 70, \<70\] were considered as stratification factors.||1.750|0.417|0.7179
91574289|NCT05032066|183036876|SUPERIORITY||Odds Ratio (OR)|0.469||||0.0706|TWO_SIDED|90.0|0.236|0.934|||Stratified logistic regression|||The percentage of participants with a decrease in FVC% predicted ≥10% from baseline at Week 52 were analyzed with observed data using a stratified logistic regression model. Baseline value and treatment were considered as factors in the model and prior use of approved IPF therapy \[yes or no\], FVC% predicted at baseline \[≥ 70, \<70\] were considered as stratification factors.||0.934|0.236|0.0706
91574290|NCT05032066|183036877|SUPERIORITY||LS Mean Difference|16.71|STANDARD_ERROR_OF_MEAN|18.109||0.3579|TWO_SIDED|90.0|-13.3|46.73|||MMRM|||Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\], as used in IRT randomization), visit week, and treatment by visit week interaction.||46.73|-13.30|0.3579
91574291|NCT05032066|183036877|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|18.173||0.946|TWO_SIDED|90.0|-31.35|28.88|||MMRM|||Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\], as used in IRT randomization), visit week, and treatment by visit week interaction.||28.88|-31.35|0.9460
91574292|NCT05032066|183036878|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.3||0.6091|TWO_SIDED|90.0|-5.0|2.6|||MMRM|||Estimated from a MMRM with unstructured variance-covariance matrix, that included treatment group, time point, treatment by timepoint interaction, and stratification factors as covariates.||2.6|-5.0|0.6091
91574293|NCT05032066|183036878|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.31||0.6374|TWO_SIDED|90.0|-4.9|2.7|||MMRM|||Estimated from a MMRM with unstructured variance-covariance matrix, that included treatment group, time point, treatment by timepoint interaction, and stratification factors as covariates.||2.7|-4.9|0.6374
91574294|NCT05032066|183036879|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|2.69||0.1526|TWO_SIDED|90.0|-0.6|8.3|||MMRM|||Impact Total Score Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors baseline FVC% predicted, treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\]), visit week, and treatment by visit week interaction.||8.3|-0.6|0.1526
91574295|NCT05032066|183036879|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.72||0.4421|TWO_SIDED|90.0|-2.4|6.6|||MMRM|||Impact Total Score Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors baseline FVC% predicted, treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\]), visit week, and treatment by visit week interaction.||6.6|-2.4|0.4421
91574296|NCT05032066|183036879|SUPERIORITY||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.98||0.0936|TWO_SIDED|90.0|0.1|6.6|||MMRM|||Symptoms Total Score Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors baseline FVC% predicted, treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\]), visit week, and treatment by visit week interaction.||6.6|0.1|0.0936
91574297|NCT05032066|183036879|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.3129|TWO_SIDED|90.0|-1.3|5.3|||MMRM|||Symptoms Total Score Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors baseline FVC% predicted, treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\]), visit week, and treatment by visit week interaction.||5.3|-1.3|0.3129
91574298|NCT05032066|183036880|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.644||0.5832|TWO_SIDED|90.0|-1.42|0.71|||MMRM|||Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors baseline FVC% predicted, treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\]), visit week, and treatment by visit week interaction.||0.71|-1.42|0.5832
91574299|NCT05032066|183036880|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.648||0.1297|TWO_SIDED|90.0|-2.06|0.09|||MMRM|||Estimated from a mixed effect repeated measurement analysis with unstructured variance-covariance matrix, that included factors baseline FVC% predicted, treatment (300 mg HZN-825 QD, 300 mg HZN-825 BID, placebo), the Baseline factors used for stratifying randomization as covariates (prior use of approved IPF therapy \[yes/no\] and Baseline FVC% Predicted \[\>=70, \<70\]), visit week, and treatment by visit week interaction.||0.09|-2.06|0.1297
91574300|NCT05032066|183036881|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9996|TWO_SIDED|90.0|0.34|2.9|||Regression, Cox|||Estimated from a stratified Cox proportional hazards regression model stratified by prior use of approved IPF therapy \[yes or no\] and FVC% predicted at baseline \[= 70, \<70\] and treatment group as factor. Placebo group is the reference group for the analysis.||2.90|0.34|0.9996
91574301|NCT05032066|183036881|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.3721|TWO_SIDED|90.0|0.66|4.48|||Regression, Cox|||Estimated from a stratified Cox proportional hazards regression model stratified by prior use of approved IPF therapy \[yes or no\] and FVC% predicted at baseline \[= 70, \<70\] and treatment group as factor. Placebo group is the reference group for the analysis.||4.48|0.66|0.3721
91574302|NCT05032066|183036882|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.4778|TWO_SIDED|90.0|0.63|3.32|||Regression, Cox|||Estimated from a stratified Cox proportional hazards regression model stratified by prior use of approved IPF therapy \[yes or no\] and FVC% predicted at baseline \[= 70, \<70\] and treatment group as factor. Placebo group is the reference group for the analysis.||3.32|0.63|0.4778
91574303|NCT05032066|183036882|SUPERIORITY||Hazard Ratio (HR)|2.52||||0.0438|TWO_SIDED|90.0|1.22|5.61|||Regression, Cox|||Estimated from a stratified Cox proportional hazards regression model stratified by prior use of approved IPF therapy \[yes or no\] and FVC% predicted at baseline \[= 70, \<70\] and treatment group as factor. Placebo group is the reference group for the analysis.||5.61|1.22|0.0438
91574304|NCT01124838|183036885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.004|TWO_SIDED|95.0|0.39|0.84|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.84|0.39|0.004
91574305|NCT01124838|183036885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.74|0.37|<0.001
91574306|NCT01124838|183036886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.14||||0.218|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|From ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.08|-0.37|0.218
91574307|NCT01124838|183036886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.15||||0.164|TWO_SIDED|95.0|-0.36|0.06|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.06|-0.36|0.164
91574308|NCT01124838|183036887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.13||||0.07|TWO_SIDED|95.0|-0.28|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.28|0.070
91574309|NCT01124838|183036887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.17||||0.016|TWO_SIDED|95.0|-0.31|-0.03|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.03|-0.31|0.016
91574310|NCT01124838|183036888|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.096|TWO_SIDED|95.0|-0.08|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.08|0.096
91574311|NCT01124838|183036888|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.044|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.00|-0.09|0.044
91574312|NCT01124838|183036889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.491|TWO_SIDED|95.0|0.34|1.69|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.69|0.34|0.491
91574313|NCT01124838|183036889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.185|TWO_SIDED|95.0|0.28|1.28|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.28|0.28|0.185
91574314|NCT01124838|183036890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-2.3||||0.451|TWO_SIDED|95.0|-8.5|3.8|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.8|-8.5|0.451
91574315|NCT01124838|183036890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-3.9||||0.174|TWO_SIDED|95.0|-9.7|1.8|||ANOVA|From ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.8|-9.7|0.174
91574316|NCT01124838|183036891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.12||||0.16|TWO_SIDED|95.0|-0.84|5.08|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.08|-0.84|0.160
91574317|NCT01124838|183036891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.77||||0.205|TWO_SIDED|95.0|-0.97|4.52|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.52|-0.97|0.205
91574318|NCT01124838|183036892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.88||||0.401|TWO_SIDED|95.0|-2.53|6.29|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.29|-2.53|0.401
91514163|NCT02347761|182900401|SUPERIORITY||Least Squares Mean (SE)|0.1264|STANDARD_ERROR_OF_MEAN|0.02076|<|0.0001|TWO_SIDED|95.0|0.0856|0.1672||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least squares mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1672|0.0856|<0.0001
91514164|NCT02347761|182900401|SUPERIORITY|In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|LS mean (SE)|0.1052|STANDARD_ERROR_OF_MEAN|0.0206|<|0.0001|TWO_SIDED|95.0|0.0647|0.1457|||LS mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1457|0.0647|<0.0001
91514165|NCT01255358|182900421|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-4.0|STANDARD_DEVIATION|7.5||0.02|TWO_SIDED|95.0|-7.1|-0.9|||Wilcoxon (Mann-Whitney)|||The primary analysis on ICARS Total score has been conducted on the ITT Population employing carry-forward and carry-backward procedures for missing data imputation, in order to evaluate all enrolled patients.||-0.9|-7.1|0.02
91514166|NCT01255358|182900422|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-5.2|STANDARD_DEVIATION|7.0||0.0031|TWO_SIDED|95.0|-8.4|-2.0|||Wilcoxon (Mann-Whitney)|||Overall analysis on the PP Population||-2|-8.4|0.0031
91574319|NCT01124838|183036892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.36||||0.256|TWO_SIDED|95.0|-1.73|6.45|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.45|-1.73|0.256
91574320|NCT01124838|183036893|SUPERIORITY_OR_OTHER_LEGACY||Mena Difference|-0.1||||0.967|TWO_SIDED|95.0|-4.81|4.61|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.61|-4.81|0.967
91574321|NCT01124838|183036893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.87||||0.714|TWO_SIDED|95.0|-5.53|3.79|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.79|-5.53|0.714
91574322|NCT01124838|183036894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|0.56||||0.83|TWO_SIDED|95.0|-4.56|5.68|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.68|-4.56|0.830
91574323|NCT01124838|183036894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.49||||0.842|TWO_SIDED|95.0|-5.32|4.34|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.34|-5.32|0.842
91574324|NCT03660826|183036941|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.93|TWO_SIDED|95.0|0.91|2.3||Comparing Arm II vs Arm I (reference group)|Log Rank||||Comparing Arm II vs Arm I (reference group)|2.30|0.91|0.93
91574325|NCT03660826|183036941|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.06|TWO_SIDED|95.0|0.43|1.14|||Log Rank|||Comparing Arm III vs Arm I||1.14|0.43|0.06
91574326|NCT03660826|183036941|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.62|TWO_SIDED|95.0|0.67|1.7|||Log Rank|||Comparing Arm IV vs Arm VII||1.70|0.67|0.62
91574327|NCT03660826|183036941|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|95.0|0.58|1.46|||Log Rank|||Comparing Arm V vs Arm VII||1.46|0.58|0.36
91574328|NCT03660826|183036941|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.49|1.25|||Log Rank|||Comparing Arm VI vs VII||1.25|0.49|0.14
91574329|NCT03931746|183036947|SUPERIORITY||Hodges-Lehmann median difference|-3.5||||0.04|TWO_SIDED|95.0|-8.0|-0.5|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||-0.5|-8.0|0.04
91574330|NCT03931746|183036948|SUPERIORITY||Hodges-Lehmann median difference|-2.5||||0.75|TWO_SIDED|95.0|-9.0|12.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft minus No Porcine Xenograft.|||12|-9|0.75
91574331|NCT03931746|183036949|SUPERIORITY||Hodges-Lehmann median difference|1.0||||1|TWO_SIDED|95.0|-19.0|20.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||20.0|-19.0|1
91574332|NCT03931746|183036950|SUPERIORITY||Hodges-Lehmann median difference|0.01||||1|TWO_SIDED|95.0|-0.26|0.33|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft vs. No Porcine Xenograft.|||0.33|-0.26|1
91574333|NCT03931746|183036951|SUPERIORITY||Hodges-Lehmann median difference|0.0||||1|TWO_SIDED|95.0|-6.0|4.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||4|-6|1
91574334|NCT03931746|183036952|SUPERIORITY||Hodges-Lehmann median difference|0.5||||0.54|TWO_SIDED|95.0|-1.0|2.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||2|-1|0.54
91574335|NCT03931746|183036953|SUPERIORITY||Odds Ratio (OR)|0.69||||1|TWO_SIDED|95.0|0.03|13.3|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||13.3|0.03|1
91574336|NCT03931746|183036954|SUPERIORITY||Risk Difference (RD)|-0.167||||0.43|TWO_SIDED|95.0|-0.564|0.185|||Fisher Exact||"The risk difference is calculated as the outcome risk in the Porcine Xenograft group minus the outcome risk in the No Porcine Xenograft group. The confidence interval for the risk difference was calculated using the Newcombe hybrid score method."|||0.185|-0.564|0.43
91574337|NCT03931746|183036955|SUPERIORITY||Odds Ratio (OR)|0.6||||1|TWO_SIDED|95.0|0.006|55.9|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||55.9|0.006|1
91574338|NCT01183390|183036957|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.6|||||TWO_SIDED|90.0|95.1|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.28|95.10|
91574339|NCT01183390|183036958|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|96.99|101.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.80|96.99|
91574340|NCT04057573|183036964|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0004|TWO_SIDED|95.0|1.737|6.835||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.835|1.737|0.0004
91574341|NCT04057573|183036965|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.296|6.949||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.949|2.296|< 0.0001
91574342|NCT04057573|183036966|SUPERIORITY||Odds Ratio (OR)|15.29||||0.0065|TWO_SIDED|95.0|2.15|108.739||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||108.739|2.150|0.0065
91574343|NCT04057573|183036967|SUPERIORITY||Odds Ratio (OR)|4.29||||0.0006|TWO_SIDED|95.0|1.865|9.853||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.853|1.865|0.0006
91574344|NCT04057573|183036968|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0013|TWO_SIDED|95.0|1.851|12.755||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||12.755|1.851|0.0013
91574345|NCT04057573|183036969|SUPERIORITY||Least squares mean difference|-19.5|STANDARD_ERROR_OF_MEAN|4.59|<|0.0001|TWO_SIDED|95.0|-28.46|-10.45||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-10.45|-28.46|< 0.0001
91574346|NCT04057573|183036972|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.267|6.246||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.246|2.267|< 0.0001
91574347|NCT04057573|183036974|SUPERIORITY||Least squares mean difference|-28.59|STANDARD_ERROR_OF_MEAN|4.94|<|0.0001|TWO_SIDED|95.0|-38.33|-18.86|||mixed-effect model; repeated measurement|||||-18.86|-38.33|<0.0001
91574348|NCT04057573|183036977|SUPERIORITY||least squares mean difference|-19.85|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-26.55|-13.16|||mixed-effect model; repeated measurement|||||-13.16|-26.55|<0.0001
91574349|NCT04057573|183036979|SUPERIORITY||least squares mean difference|-11.95|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-17.23|-6.67|||mixed-effect model; repeated measurement|||||-6.67|-17.23|<0.0001
91574350|NCT04057573|183036981|SUPERIORITY||Odds Ratio (OR)|3.75|||<|0.0001|TWO_SIDED|95.0|2.121|6.63||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||6.630|2.121|< 0.0001
91574351|NCT04057573|183036981|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0436|TWO_SIDED|95.0|1.045|20.192||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||20.192|1.045|0.0436
91574352|NCT04057573|183036981|SUPERIORITY||Odds Ratio (OR)|1.35||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
91574353|NCT04057573|183036984|SUPERIORITY||least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.235|TWO_SIDED|95.0|-1.6|0.39|||mixed-effect model; repeated measurement|||||0.39|-1.60|0.2350
91574354|NCT04991753|183036988|SUPERIORITY||Least square mean difference|-0.45|||=|0.224|TWO_SIDED|95.0|-1.17|0.28|||ANCOVA|||||0.28|-1.17|=0.224
91574355|NCT00233480|183037001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED|95.0|||||paired t test|||||||0.025
91574356|NCT01475305|183037007|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|||2.05|0.00|
91574357|NCT01475305|183037008|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by quantitative real-time RT-PCR||6.24|0.16|
91574358|NCT01475305|183037008|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by DFA||2.05|0.00|
91574359|NCT01475305|183037008|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by Any Method||6.24|0.16|
91574360|NCT04486625|183037037|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% confidence intervals (CIs) for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|79.48|||||TWO_SIDED|90.0|66.52|94.96||||||||94.96|66.52|
91574361|NCT04486625|183037038|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|75.58|||||TWO_SIDED|90.0|66.1|86.43||||||||86.43|66.10|
91574362|NCT04486625|183037039|OTHER|ANOVA was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of of adjusted geometric means|124.19|||||TWO_SIDED|90.0|100.18|153.97||||||||153.97|100.18|
91574363|NCT04486625|183037040|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|102.42|||||TWO_SIDED|90.0|87.55|119.83||||||||119.83|87.55|
91574364|NCT00725270|183037066|SUPERIORITY_OR_OTHER|||||||0.812|||||||Mixed Models Analysis|||Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication \* time interaction.||||.812
91574365|NCT00725270|183037067|SUPERIORITY_OR_OTHER||eta sq|0.157||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||.203
91574366|NCT02980042|183037068|SUPERIORITY||Risk Ratio (RR)|0.6616||||0.1996|TWO_SIDED|95.0|0.3666|1.1942|||Generalized estimating equations|GEE was necessary because there are repeated measures on subjects.|This is comparing the Switching group to the Comparator group|||1.1942|.3666|0.1996
91574367|NCT02980042|183037069|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.5299|1.8872|||Generalized estimating equations|GEE was used because there are repeated measures on subjects|Comparing Switching group Day 1 to combined Comparator group|||1.8872|.5299|1.0000
91574368|NCT02980042|183037069|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0053|TWO_SIDED|95.0|0.1006|0.8114|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|Switching group Day 15 was compared to combined Comparator group.|||.8114|.1006|0.0053
91574369|NCT02980042|183037069|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.6474|TWO_SIDED|95.0|0.4385|1.6753|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.6753|.4385|0.6474
91574370|NCT02980042|183037073|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0075|TWO_SIDED|95.0|0.1072|0.7613|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||.7613|.1072|0.0075
91574371|NCT02980042|183037073|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.593|TWO_SIDED|95.0|0.4868|1.5093|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.5093|.4868|0.5930
91574372|NCT02980042|183037073|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0209|TWO_SIDED|95.0|1.126|7.9932|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||7.9932|1.1260|0.0209
91574373|NCT02980042|183037078|OTHER||Mean Difference (Net)|0.0||||0.005|TWO_SIDED|95.0|-27.05|-5.01||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.01|-27.05|0.005
91574374|NCT02980042|183037079|OTHER||Mean Difference (Net)|2.55|||<|0.0001|TWO_SIDED|95.0|1.54|3.56||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||3.56|1.54|<0.0001
91574375|NCT02980042|183037080|OTHER||Median Difference (Net)|8.58|||<|0.0001|TWO_SIDED|95.0|6.33|10.82||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||10.82|6.33|<0.0001
91574376|NCT02980042|183037081|OTHER||Mean Difference (Net)|-7.37|||<|0.0001|TWO_SIDED|95.0|-10.19|-4.55||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.55|-10.19|<0.0001
91574377|NCT02980042|183037082|OTHER||Mean Difference (Net)|44.32|||<|0.0001|TWO_SIDED|95.0|29.59|59.05||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||59.05|29.59|<0.0001
91574378|NCT02980042|183037083|OTHER||Mean Difference (Net)|353.35||||0.0002|TWO_SIDED|95.0|175.23|531.46||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||531.46|175.23|0.0002
91574379|NCT02980042|183037084|OTHER||Mean Difference (Net)|176.9|||<|0.0001|TWO_SIDED|95.0|124.5|229.31||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||229.31|124.50|<0.0001
91574380|NCT02980042|183037085|OTHER||Mean Difference (Net)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.32||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.32|0.07|0.0020
91574381|NCT02980042|183037086|OTHER||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.32|0.77||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.77|0.32|<0.0001
91574382|NCT02980042|183037087|OTHER||Mean Difference (Net)|-46.16||||0.0091|TWO_SIDED|95.0|-80.61|-11.72||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-11.72|-80.61|0.0091
91574383|NCT02980042|183037088|OTHER||Mean Difference (Net)|55.26||||0.0002|TWO_SIDED|95.0|27.0|83.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||83.52|27.00|0.0002
91574384|NCT02980042|183037089|OTHER||Mean Difference (Net)|-17.24||||0.0044|TWO_SIDED|95.0|-28.96|-5.51||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.51|-28.96|0.0044
91574385|NCT02980042|183037090|OTHER||Mean Difference (Net)|16.01|||<|0.0001|TWO_SIDED|95.0|9.75|22.28||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||22.28|9.75|<0.0001
91574386|NCT02980042|183037091|OTHER||Mean Difference (Net)|429.08|||<|0.0001|TWO_SIDED|95.0|296.07|562.1||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||562.10|296.07|<0.0001
91574387|NCT02980042|183037092|OTHER||Mean Difference (Net)|1.23||||0.0101|TWO_SIDED|95.0|0.3|2.16||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.16|0.30|0.0101
91574388|NCT02980042|183037093|OTHER||Mean Difference (Net)|8.69|||<|0.0001|TWO_SIDED|95.0|4.87|12.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||12.52|4.87|<0.0001
91574389|NCT02980042|183037094|OTHER||Mean Difference (Net)|1.53|||<|0.0001|TWO_SIDED|95.0|1.04|2.03||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.03|1.04|<0.0001
91574390|NCT02980042|183037095|OTHER||Mean Difference (Net)|-33.17|||<|0.0001|TWO_SIDED|95.0|-38.91|-27.44||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-27.44|-38.91|<0.0001
91574391|NCT02980042|183037096|OTHER||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.26|-0.98|0.0008
91574392|NCT02980042|183037097|OTHER||Mean Difference (Net)|2.01|||<|0.0001|TWO_SIDED|95.0|1.23|2.79||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.79|1.23|<0.0001
91574393|NCT02980042|183037098|OTHER||Mean Difference (Net)|-7.84|||<|0.0001|TWO_SIDED|95.0|-9.87|-5.81||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.81|-9.87|<0.0001
91574394|NCT02980042|183037099|OTHER||Mean Difference (Net)|-14.2||||0.0022|TWO_SIDED|95.0|-23.15|-5.25||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.25|-23.15|0.0022
91574395|NCT02980042|183037100|OTHER||Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.43|0.17|<0.0001
91574396|NCT02980042|183037101|OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.22|0.61||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.61|0.22|<0.0001
91574397|NCT02980042|183037102|OTHER||Mean Difference (Net)|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.5||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.50|-0.95|<0.0001
91574398|NCT02980042|183037103|OTHER||Mean Difference (Net)|-19.31|||<|0.0001|TWO_SIDED|95.0|-22.64|-15.98||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-15.98|-22.64|<0.0001
91574399|NCT02980042|183037104|OTHER||Mean Difference (Net)|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.85|-4.08||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.08|-9.85|<0.0001
91574400|NCT02980042|183037105|OTHER||Mean Difference (Net)|-23.22||||0.0061|TWO_SIDED|95.0|-39.66|-6.78||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-6.78|-39.66|0.0061
91514167|NCT01255358|182900427|OTHER|VABS Total score and subscales have been analyzed with a RMANOVA design, using age as covariate (dichotomized as Low- or High-, using median age as threshold).|Median Difference (Final Values)|1.3|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)|||VABS total score at V7||1.8|0.8|<0.0001
91514168|NCT01255358|182900428|OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.1|<|0.0001|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|1|<0.0001
91514169|NCT04079933|182900462|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-12.6||||0.2347|TWO_SIDED|95.0|-33.5|8.27|||t-test, 2 sided||"Difference in Least Square (LS) means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||8.27|-33.5|0.2347
91574401|NCT02980042|183037106|OTHER||Mean Difference (Net)|-5.69|||<|0.0001|TWO_SIDED|95.0|-7.24|-4.14||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.14|-7.24|<0.0001
91574402|NCT02980042|183037107|OTHER||Mean Difference (Net)|-0.84||||0.0077|TWO_SIDED|95.0|-1.45|-0.23||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.23|-1.45|0.0077
91574403|NCT02980042|183037108|OTHER||Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.27||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.27|-0.37|<0.0001
91574404|NCT02356705|183037110|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91574405|NCT02356705|183037111|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
91574406|NCT02356705|183037112|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
91574407|NCT02356705|183037114|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
91574408|NCT02356705|183037115|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
91574409|NCT00592293|183037178|OTHER||Cumulative incidence|17.0|||||TWO_SIDED|95.0|9.1|27.6||||||||27.6|9.1|
91574410|NCT00592293|183037179|OTHER||Percent Survival, Local Control|87.1|||||TWO_SIDED|95.0|78.1|93.7||||||||93.7|78.1|
91574411|NCT01606319|183037184|SUPERIORITY_OR_OTHER||relative rate|0.94||||0.67|TWO_SIDED|95.0|0.69|1.28|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.28|.69|0.67
91574412|NCT01606319|183037185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5|TWO_SIDED|95.0|-0.039|0.0019|||ANCOVA|||||.0019|-0.039|0.5
91574413|NCT01606319|183037186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.69|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||||0.6|-0.9|0.69
91574414|NCT01606319|183037187|SUPERIORITY_OR_OTHER||relative rate|0.99||||0.94|TWO_SIDED|95.0|0.72|1.37|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.37|0.72|.94
91574415|NCT01270828|183037188|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
91574416|NCT01270828|183037189|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
91574417|NCT01270828|183037190|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
91574418|NCT01270828|183037191|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
91574419|NCT01270828|183037192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.26|-0.62|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.62|-1.26|<0.0001
91574420|NCT01270828|183037192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.21|-0.61|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.61|-1.21|<0.0001
91574421|NCT01270828|183037193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.75|-1.47|<0.0001
91574422|NCT01270828|183037193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.65|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.65|-1.34|<0.0001
91574423|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0324|TWO_SIDED|95.0|-6.1|-0.3|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-6.1|0.0324
91574424|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0223|TWO_SIDED|95.0|-6.1|-0.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.5|-6.1|0.0223
91574425|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.0098|TWO_SIDED|95.0|-6.6|-0.9|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-0.9|-6.6|0.0098
91574426|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0033|TWO_SIDED|95.0|-6.7|-1.4|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-1.4|-6.7|0.0033
91574427|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.1|-3.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.5|-11.1|0.0002
91574428|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.2|-5.2|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-5.2|-12.2|<0.0001
91574429|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.5264|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|||This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.6|-2.8|0.5264
91574430|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.452|TWO_SIDED|95.0|-5.2|2.3|||ANCOVA|||This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.3|-5.2|0.4520
91574431|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.3714|TWO_SIDED|95.0|-4.7|1.8|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||1.8|-4.7|0.3714
91574432|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.5639|TWO_SIDED|95.0|-4.2|2.3|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||2.3|-4.2|0.5639
91574433|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.3223|TWO_SIDED|95.0|-2.4|7.3|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.3|-2.4|0.3223
91574434|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7||||0.2742|TWO_SIDED|95.0|-2.2|7.6|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.6|-2.2|0.2742
91574435|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9816|TWO_SIDED|95.0|-3.2|3.1|||ANCOVA|||This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.1|-3.2|0.9816
91574436|NCT01270828|183037194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9282|TWO_SIDED|95.0|-2.9|3.2|||ANCOVA|||This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.2|-2.9|0.9282
91574437|NCT01270828|183037195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.1635|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.4|-0.1|0.1635
91574438|NCT01270828|183037195|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.0363||95.0|0.0|0.5|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.5|0.0|0.0363
91574439|NCT01270828|183037196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432|||||||Chi-squared|||This analysis is for Week 6||||0.432
91574440|NCT01270828|183037196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987|||||||Chi-squared|||This analysis is for Week 19||||0.987
91574441|NCT01270828|183037197|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.65|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.||2.65|1.30|0.0007
91574442|NCT01270828|183037197|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.32||||0.0009|TWO_SIDED|95.0|1.41|3.81|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.||3.81|1.41|0.0009
91574443|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4||||0.0003|TWO_SIDED|95.0|3.4|11.5|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.5|3.4|0.0003
91574444|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|||<|0.0001|TWO_SIDED|95.0|4.0|11.3|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.3|4.0|<0.0001
91574445|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.0275|TWO_SIDED|95.0|0.4|6.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||6.0|0.4|0.0275
91574446|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.0001|TWO_SIDED|95.0|2.8|8.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||8.0|2.8|<0.0001
91574447|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0735|TWO_SIDED|95.0|-0.3|6.4|||ANCOVA|||This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.3|0.0735
91574448|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0684|TWO_SIDED|95.0|-0.2|6.2|||ANCOVA|||This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.2|-0.2|0.0684
91574449|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1197|TWO_SIDED|95.0|-0.7|6.4|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.7|0.1197
91574450|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.221|TWO_SIDED|95.0|-1.3|5.5|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.5|-1.3|0.2210
91574451|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.0847|TWO_SIDED|95.0|-0.5|7.1|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.1|-0.5|0.0847
91574452|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.0365|TWO_SIDED|95.0|0.3|7.8|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.8|0.3|0.0365
91574453|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.2749|TWO_SIDED|95.0|-1.2|4.3|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||4.3|-1.2|0.2749
91574454|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0806|TWO_SIDED|95.0|-0.3|5.2|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.2|-0.3|0.0806
91574455|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0||||0.0082|TWO_SIDED|95.0|0.5|3.4|||ANCOVA|||This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.4|0.5|0.0082
91574456|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.0008|TWO_SIDED|95.0|1.0|3.7|||ANCOVA|||This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.7|1.0|0.0008
91574457|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.2097|TWO_SIDED|95.0|-0.8|2.5|||ANCOVA|||This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.5|-0.8|0.2097
91574458|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.1669|TWO_SIDED|95.0|-0.5|2.8|||ANCOVA|||This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.8|-0.5|0.1669
91574459|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1466|TWO_SIDED|95.0|-1.0|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|-1.0|0.1466
91574460|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4||||0.0439|TWO_SIDED|95.0|0.1|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|0.1|0.0439
91574461|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.025|TWO_SIDED|95.0|0.6|9.3|||ANCOVA|||This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.3|0.6|0.0250
91574462|NCT01270828|183037198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.0107|TWO_SIDED|95.0|1.3|9.5|||ANCOVA|||This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.5|1.3|0.0107
91574463|NCT01270828|183037199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.64|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.64|-1.23|<0.0001
91574464|NCT01270828|183037199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.58|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.58|-1.12|<0.0001
91574465|NCT01270828|183037200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0154|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0154
91574466|NCT01270828|183037200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0027|TWO_SIDED|95.0|-1.3|-0.3|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-1.3|0.0027
91574467|NCT01270828|183037200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0166|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0166
91574468|NCT01270828|183037200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0217|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.1|0.0217
91574469|NCT01270828|183037201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.5|-3.0|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.0|-5.5|<0.0001
91574470|NCT01270828|183037201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.7|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-2.7|-5.0|<0.0001
91574471|NCT01270828|183037201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.5|-2.7|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.7|-6.5|<0.0001
91574472|NCT01270828|183037201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-6.0|-2.4|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.4|-6.0|<0.0001
91574473|NCT01270828|183037202|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.77||||0.0161|TWO_SIDED|95.0|1.34|17.0|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||17.00|1.34|0.0161
91574474|NCT01270828|183037202|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0378|TWO_SIDED|95.0|1.05|5.85|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||5.85|1.05|0.0378
91574475|NCT01270828|183037202|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0901|TWO_SIDED|95.0|0.93|2.81|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||2.81|0.93|0.0901
91574476|NCT02870972|183037213|SUPERIORITY||Difference in Least Square Means|-0.458|||<|0.001|TWO_SIDED|95.0|-0.703|-0.214|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.214|-0.703|<0.001
91574477|NCT02870972|183037213|SUPERIORITY||Difference in Least Square Means|-0.433||||0.006|TWO_SIDED|95.0|-0.74|-0.127|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.127|-0.740|0.006
91574478|NCT02870972|183037213|SUPERIORITY||Difference in Least Square Means|-0.425||||0.012|TWO_SIDED|95.0|-0.755|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.095|-0.755|0.012
91574479|NCT02870972|183037213|SUPERIORITY||Difference in Least Square Means|-0.703|||<|0.001|TWO_SIDED|95.0|-1.033|0.373|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.373|-1.033|<0.001
91574480|NCT02870972|183037213|SUPERIORITY||Difference in Least Square Means|-0.1||||0.639|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.32|-0.52|0.639
91574481|NCT02870972|183037214|SUPERIORITY||Difference vs placebo (%)|17.7||||0.155|TWO_SIDED|95.0|-3.4|38.8|||Fisher Exact|||||38.8|-3.4|0.155
91574482|NCT02870972|183037214|SUPERIORITY||Difference vs placebo (%)|16.9||||0.277|TWO_SIDED|95.0|-6.3|40.1|||Fisher Exact|||||40.1|-6.3|0.277
91574483|NCT02870972|183037214|SUPERIORITY||Difference vs placebo (%)|24.0||||0.064|TWO_SIDED|95.0|-1.2|49.2|||Fisher Exact|||||49.2|-1.2|0.064
91574484|NCT02870972|183037214|SUPERIORITY||Difference vs placebo (%)|-4.5||||1|TWO_SIDED|95.0|-13.2|4.2|||Fisher Exact|||||4.2|-13.2|1.000
91574485|NCT02870972|183037214|SUPERIORITY||Difference vs placebo (%)|-16.2||||0.097|TWO_SIDED|95.0|-30.2|-2.2|||Fisher Exact|||||-2.2|-30.2|0.097
91574486|NCT02870972|183037215|SUPERIORITY||Difference in Least Square Means|-0.061||||0.439|TWO_SIDED|95.0|-0.216|0.094|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.094|-0.216|0.439
91574487|NCT02870972|183037215|SUPERIORITY||Difference in Least Square Means|-0.004||||0.968|TWO_SIDED|95.0|-0.198|0.19|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.190|-0.198|0.968
91574488|NCT02870972|183037215|SUPERIORITY||Difference in Least Square Means|-0.045||||0.667|TWO_SIDED|95.0|-0.254|0.164|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.164|-0.254|0.667
91574489|NCT02870972|183037215|SUPERIORITY||Difference in Least Square Means|-0.197||||0.065|TWO_SIDED|95.0|-0.406|0.012|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.012|-0.406|0.065
91574490|NCT02870972|183037215|SUPERIORITY||Difference in Least Square Means|0.035||||0.797|TWO_SIDED|95.0|-0.232|0.301|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.301|-0.232|0.797
91574491|NCT02870972|183037216|SUPERIORITY||Difference in Least Square Means|-0.364|||<|0.001|TWO_SIDED|95.0|-0.547|-0.181|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.181|-0.547|<0.001
91574492|NCT02870972|183037216|SUPERIORITY||Difference in Least Square Means|-0.384||||0.001|TWO_SIDED|95.0|-0.613|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.613|0.001
91574493|NCT02870972|183037216|SUPERIORITY||Difference in Least Square Means|-0.401||||0.002|TWO_SIDED|95.0|-0.647|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.647|0.002
91574494|NCT02870972|183037216|SUPERIORITY||Difference in Least Square Means|-0.445|||<|0.001|TWO_SIDED|95.0|-0.692|-0.198|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.198|-0.692|<0.001
91574495|NCT02870972|183037216|SUPERIORITY||Difference in Least Square Means|-0.08||||0.614|TWO_SIDED|95.0|-0.394|0.234|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.234|-0.394|0.614
91574496|NCT02870972|183037217|SUPERIORITY||Difference in Least Square Means|-0.326||||0.006|TWO_SIDED|95.0|-0.557|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.095|-0.557|0.006
91574497|NCT02870972|183037217|SUPERIORITY||Difference in Least Square Means|-0.293||||0.047|TWO_SIDED|95.0|-0.582|0.004|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.004|-0.582|0.047
91574498|NCT02870972|183037217|SUPERIORITY||Difference in Least Square Means|-0.327||||0.04|TWO_SIDED|95.0|-0.638|-0.016|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.016|-0.638|0.040
91574499|NCT02870972|183037217|SUPERIORITY||Difference in Least Square Means|-0.558|||<|0.001|TWO_SIDED|95.0|-0.87|-0.247|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.247|-0.870|<0.001
91574500|NCT02870972|183037217|SUPERIORITY||Difference in Least Square Means|0.057||||0.775|TWO_SIDED|95.0|-0.339|0.454|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.454|-0.339|0.775
91574501|NCT02870972|183037218|SUPERIORITY||Difference in Least Square Means|-4.449||||0.209|TWO_SIDED|95.0|-11.453|2.555|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.555|-11.453|0.209
91574502|NCT02870972|183037218|SUPERIORITY||Difference in Least Square Means|-9.103||||0.019|TWO_SIDED|95.0|-16.639|-1.567|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-1.567|-16.639|0.019
91574503|NCT02870972|183037218|SUPERIORITY||Difference in Least Square Means|-11.263||||0.004|TWO_SIDED|95.0|-18.808|-3.718|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-3.718|-18.808|0.004
91574504|NCT02870972|183037218|SUPERIORITY||Difference in Least Square Means|4.04||||0.405|TWO_SIDED|95.0|-5.586|13.665|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||13.665|-5.586|0.405
91574505|NCT02870972|183037219|SUPERIORITY||Difference in Least Square Means|-8.12||||0.135|TWO_SIDED|95.0|-18.826|2.584|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.584|-18.826|0.135
91574506|NCT02870972|183037219|SUPERIORITY||Difference in Least Square Means|-8.92||||0.121|TWO_SIDED|95.0|-20.26|2.41|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.410|-20.260|0.121
91574507|NCT02870972|183037219|SUPERIORITY||Difference in Least Square Means|-24.49|||<|0.001|TWO_SIDED|95.0|-35.834|-13.137|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-13.137|-35.834|<0.001
91574508|NCT02870972|183037219|SUPERIORITY||Difference in Least Square Means|-7.84||||0.284|TWO_SIDED|95.0|-22.316|6.64|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||6.640|-22.316|0.284
91574509|NCT02870972|183037220|SUPERIORITY||Difference in Least Square Means|-8.27||||0.067|TWO_SIDED|95.0|-17.132|0.592|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.592|-17.132|0.067
91574510|NCT02870972|183037220|SUPERIORITY||Difference in Least Square Means|-7.073||||0.136|TWO_SIDED|95.0|-16.432|2.287|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.287|-16.432|0.136
91574511|NCT02870972|183037220|SUPERIORITY||Difference in Least Square Means|-11.484||||0.015|TWO_SIDED|95.0|-20.642|-2.325|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-2.325|-20.642|0.015
91574512|NCT02870972|183037220|SUPERIORITY||Difference in Least Square Means|-9.785||||0.114|TWO_SIDED|95.0|-22.001|2.431|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.431|-22.001|0.114
91574513|NCT01634269|183037221|SUPERIORITY_OR_OTHER_LEGACY||Proportion of IF implanted subjects|87.5||||0.002|TWO_SIDED|95.0|61.7|98.4|||Exact binomial|||||98.4|61.7|0.002
91574514|NCT00584077|183037270|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)||||<0.01
91574515|NCT00584077|183037271|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value was adjusted for multiple comparisons using Bonferroni test|ANOVA|||For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.||||<0.01
91574516|NCT04079634|183037284|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
91574517|NCT00479882|183037285|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least squares mean|2.4|||||TWO_SIDED|95.0|1.3|3.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||3.4|1.3|
91574518|NCT00479882|183037285|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least Squares Mean|1.4|||||TWO_SIDED|95.0|0.4|2.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||2.4|0.4|
91574519|NCT00479882|183037286|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||1.0|-1.4|
91574520|NCT00479882|183037286|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.8|||||TWO_SIDED|95.0|-1.9|0.2|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||0.2|-1.9|
91574521|NCT00479882|183037287|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.685|TWO_SIDED|95.0|-1.2|0.8|||Fisher Exact||Wilson's Method|Periods I/II||0.8|-1.2|0.685
91574522|NCT00479882|183037287|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||Wilson's Method|Period III||1.1|-1.8|
91574523|NCT00479882|183037287|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.753|TWO_SIDED|95.0|-1.6|0.9|||Fisher Exact||Wilson's Method|Periods I/II||0.9|-1.6|0.753
91574524|NCT00479882|183037287|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.8|1.4|||||Wilson's Method|Period III||1.4|-0.8|
91574525|NCT00479882|183037288|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
91574526|NCT00479882|183037288|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-0.5|1.5|||||Wilson's Method|Period III||1.5|-0.5|
91574527|NCT00479882|183037288|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.617|TWO_SIDED|95.0|-0.6|1.1|||Fisher Exact||Wilson's Method|Periods I/II||1.1|-0.6|0.617
91574528|NCT00479882|183037288|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
91574529|NCT00479882|183037289|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
91574530|NCT00479882|183037289|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
91574531|NCT00479882|183037289|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
91574532|NCT00479882|183037289|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
91574533|NCT00479882|183037290|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
91574534|NCT00479882|183037290|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
91574535|NCT00479882|183037290|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
91574536|NCT00479882|183037290|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
91574537|NCT00479882|183037291|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.497|TWO_SIDED|95.0|-0.9|0.5|||Fisher Exact|||Periods I/II||0.5|-0.9|0.497
91574538|NCT00479882|183037292|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.449|TWO_SIDED|95.0|-1.4|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-1.4|0.449
91574539|NCT00479882|183037292|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
91574540|NCT00479882|183037292|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.685|TWO_SIDED|95.0|-0.8|1.2|||Fisher Exact||Wilson's Method|Period I/II||1.2|-0.8|0.685
91574541|NCT00479882|183037292|SUPERIORITY_OR_OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-1.0|1.6|||||Wilson's Method|Period III||1.6|-1.0|
91574542|NCT00479882|183037293|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.2||||0.02|TWO_SIDED|95.0|-2.4|-0.2|||Fisher Exact||Wilson's Method|Periods I/II||-0.2|-2.4|0.020
91574543|NCT00479882|183037293|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
91574544|NCT00479882|183037293|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5||||0.452|TWO_SIDED|95.0|-1.6|0.5|||Fisher Exact||Wilson's Method|Periods I/II||0.5|-1.6|0.452
91574545|NCT00479882|183037293|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||TWO_SIDED|95.0|-1.9|1.0|||||Wilson's Method|Period III||1.0|-1.9|
91574546|NCT00479882|183037294|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Wilson's Method|Periods I/II||0.6|-0.6|
91574547|NCT00479882|183037294|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.7|1.2|||||Wilson's Method|Period III||1.2|-0.7|
91574548|NCT00479882|183037294|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Method|Periods I/II||0.9|-0.5|
91574549|NCT00479882|183037294|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.6|1.3|||||Wilson's Method|Period III||1.3|-0.6|
91574550|NCT00479882|183037295|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.4|||||TWO_SIDED|95.0|-6.6|3.8|||||Wilson's Score Method|Periods I/II||3.8|-6.6|
91574551|NCT00479882|183037295|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-8.1|4.3|||||Wilson's Score Method|Period III||4.3|-8.1|
91574552|NCT00479882|183037295|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-5.2|5.3|||||Wilson's Score Method|Periods I/II||5.3|-5.2|
91574553|NCT00479882|183037295|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-8.9|3.4|||||Wilson's Score Method|Period III||3.4|-8.9|
91574554|NCT00479882|183037296|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-2.5|2.1|||||Wilson's Score Method|Periods I/II||2.1|-2.5|
91574555|NCT00479882|183037296|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-0.5|5.2|||||Wilson's Score Method|Period III||5.2|-0.5|
91574556|NCT00479882|183037296|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-1.0|4.2|||||Wilson's Score Method|Periods I/II||4.2|-1.0|
91574557|NCT00479882|183037296|SUPERIORITY_OR_OTHER||Difference in Percentage|2.0|||||TWO_SIDED|95.0|-0.8|5.0|||||Wilson's Score Method|Period III||5.0|-0.8|
91574558|NCT00479882|183037299|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Score Method|Periods I/II||0.9|-0.5|
91574559|NCT00479882|183037299|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Wilson's Score Method|Periods I/II||0.5|-0.9|
91574560|NCT00479882|183037300|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.0||||0.341|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Factors for treatment, country and gender||||3.1|-1.1|0.341
91574561|NCT00479882|183037300|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.7||||0.004|TWO_SIDED|95.0|1.2|6.1|||ANOVA|Factors for treatment, country and gender.||||6.1|1.2|0.004
91574562|NCT00479882|183037301|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANOVA|Factors for treatment, country and gender||||1.5|-2.3|0.690
91574563|NCT00479882|183037301|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.2||||0.879|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Factors for treatment, country and gender||||2.3|-1.9|0.879
91574564|NCT02362503|183037352|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.441||Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.|ANCOVA||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||-0.441|-0.810|<0.0001
91574565|NCT02362503|183037353|OTHER||Mean Difference (Net)|45.69|||||TWO_SIDED|95.0|32.95|55.45|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>0.5 log10 c/mL.|||55.45|32.95|
91574566|NCT02362503|183037353|OTHER||Mean Difference (Net)|35.67|||||TWO_SIDED|95.0|24.16|44.25|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>1.0 log10 c/mL.|||44.25|24.16|
91574567|NCT02362503|183037359|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-16.8|16.0|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||16.0|-16.8|
91574568|NCT02362503|183037360|OTHER||Mean Difference (Net)|0.617|||||TWO_SIDED|95.0|0.082|1.151|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||1.151|0.082|
91574569|NCT00762476|183037366|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
91574570|NCT00762476|183037367|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
91574571|NCT00762476|183037368|SUPERIORITY_OR_OTHER|||||||0.3451|TWO_SIDED|95.0|||||Poisson regression|||||||0.3451
91574572|NCT01430468|183037384|EQUIVALENCE|With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.||||||0.11||||||P-value was calculated. Threshold for statistical significance (p\<0.05)|t-test, 2 sided|||The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p \< 0.05.||||0.11
91574573|NCT01281839|183037386|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|43.8|||<|0.001|TWO_SIDED|95.0|34.6|53.0|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||53.0|34.6|<0.001
91574574|NCT01281839|183037387|SUPERIORITY_OR_OTHER||Difference in proportions of SVR72|43.3|||<|0.001|TWO_SIDED|95.0|34.1|52.5|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR72 between the treatment groups.||52.5|34.1|<0.001
91574575|NCT01281839|183037388|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|44.1|||<|0.001|TWO_SIDED|95.0|34.9|53.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||53.2|34.9|<0.001
91574576|NCT01281839|183037389|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|41.0|||<|0.001|TWO_SIDED|95.0|32.1|49.9|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||49.9|32.1|<0.001
91574577|NCT04547023|183037422|OTHER||Mean Difference (Final Values)|18.7||||0.002|TWO_SIDED|95.0|7.2|30.1|||Fisher Exact|||||30.1|7.2|0.002
91574578|NCT02614183|183037512|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.48|-1.37|||Mixed Models Analysis|||||-1.37|-2.48|<.001
91574579|NCT02614183|183037512|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.31|-1.2|||Mixed Models Analysis|||||-1.20|-2.31|<.001
91574580|NCT02614183|183037513|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|2.05|3.37||||||Reduction from Baseline ≥50%||3.37|2.05|
91574581|NCT02614183|183037513|SUPERIORITY||Odds Ratio (OR)|2.48|||||TWO_SIDED|95.0|1.94|3.18||||||Reduction from Baseline ≥50%||3.18|1.94|
91574582|NCT02614183|183037513|SUPERIORITY||Odds Ratio (OR)|2.65|||||TWO_SIDED|95.0|2.04|3.45||||||Reduction from Baseline ≥75%||3.45|2.04|
91574583|NCT02614183|183037513|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|2.01|3.41||||||Reduction from Baseline ≥75%||3.41|2.01|
91574584|NCT02614183|183037513|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.96|4.01||||||Reduction from Baseline = 100%||4.01|1.96|
91574585|NCT02614183|183037513|SUPERIORITY||Odds Ratio (OR)|2.61|||||TWO_SIDED|95.0|1.81|3.75||||||Reduction from Baseline = 100%||3.75|1.81|
91574586|NCT02614183|183037514|SUPERIORITY||Mean Difference (Final Values)|7.74|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|5.2|10.28|||Mixed Models Analysis|||||10.28|5.20|<.001
91574587|NCT02614183|183037514|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|4.83|9.97|||Mixed Models Analysis|||||9.97|4.83|<.001
91574588|NCT02614183|183037515|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.28|-1.33|||Mixed Models Analysis|||||-1.33|-2.28|<.001
91574589|NCT02614183|183037515|SUPERIORITY||Odds Ratio (OR)|-1.61|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.09|-1.14|||Mixed Models Analysis|||||-1.14|-2.09|<.001
91574590|NCT02614183|183037516|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.12|||Mixed Models Analysis|||||-0.12|-0.52|<.001
91574591|NCT02614183|183037516|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.48|-0.07|||Mixed Models Analysis|||||-0.07|-0.48|<.001
91574592|NCT02614183|183037517|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-18.99|-8.97|||Mixed Models Analysis|||||-8.97|-18.99|<.001
91574593|NCT02614183|183037517|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-18.68|-8.6|||Mixed Models Analysis|||||-8.60|-18.68|<.001
91574594|NCT02614183|183037518|SUPERIORITY||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|-9.45|-3.13|||Mixed Models Analysis|||||-3.13|-9.45|<.001
91574595|NCT02614183|183037518|SUPERIORITY||Mean Difference (Final Values)|-5.19|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-8.39|-1.98|||Mixed Models Analysis|||||-1.98|-8.39|<.001
91574596|NCT02614183|183037519|SUPERIORITY||||||<|0.16|||||||Fisher Exact|||TE ADA Positive.||||<.160
91574597|NCT02614183|183037519|SUPERIORITY|||||||0.02|||||||Fisher Exact|||TE ADA Positive.||||.020
91574598|NCT02614183|183037519|SUPERIORITY|||||||0.131|||||||Fisher Exact|||Neutralizing Antibodies.||||.131
91574599|NCT02614183|183037519|SUPERIORITY|||||||0.009|||||||Fisher Exact|||Neutralizing Antibodies.||||.009
91574600|NCT00217737|183037522|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.63|1.11|||||Hazard ratio: Arm B/Arm A|||1.11|0.63|
91574601|NCT00474526|183037537|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.53|||||TWO_SIDED|95.0|3.04|6.74|||ANOVA||A (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||6.74|3.04|
91574602|NCT00474526|183037537|SUPERIORITY_OR_OTHER||Ratio of GMTs|6.39|||||TWO_SIDED|95.0|4.16|9.79|||ANOVA||C (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||9.79|4.16|
91574603|NCT00474526|183037537|SUPERIORITY_OR_OTHER||Ratio of GMTs|37.0|||||TWO_SIDED|95.0|24.0|58.0|||ANOVA||W (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||58|24|
91574604|NCT00474526|183037537|SUPERIORITY_OR_OTHER||Ratio of GMTs|38.0|||||TWO_SIDED|95.0|24.0|60.0|||ANOVA||Y (Post-vaccination GMT; group ratio US1A:US2)|"Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.~Ratio of GMTs"||60|24|
91574605|NCT00474526|183037546|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.55|0.95|||ANOVA|||Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)||0.95|0.55|
91574606|NCT00474526|183037546|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANOVA|||Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)||1.31|0.81|
91574607|NCT00474526|183037546|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.42|||||TWO_SIDED|95.0|1.18|1.72|||ANOVA|||Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)||1.72|1.18|
91574608|NCT00474526|183037546|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.27|||||TWO_SIDED|95.0|1.02|1.58|||ANOVA|||Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)||1.58|1.02|
91574609|NCT00474526|183037549|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-15.0|||||TWO_SIDED|95.0|-21.2|-8.5|||ANOVA|||Serogroup A (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||-8.5|-21.2|
91574610|NCT00474526|183037549|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.3|||ANOVA|||Serogroup C (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||0.3|-7|
91574611|NCT00474526|183037549|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|1.0|||||TWO_SIDED|95.0|-1.3|3.1|||ANOVA|||Serogroup W (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||3.1|-1.3|
91574612|NCT00474526|183037549|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.7|||ANOVA|||Serogroup Y (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||1.7|-4|
91574613|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.74|1.04|||ANOVA|||Diphtheria (Post-vaccination GMT; group ratio US1:US2)||1.04|0.74|
91574614|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.08|||||TWO_SIDED|95.0|0.92|1.28|||ANOVA|||Tetanus (Post-vaccination GMT; group ratio US1:US2)||1.28|0.92|
91574615|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.79|1.26|||ANOVA|||PT (Post-vaccination GMT; group ratio US1:US2)||1.26|0.79|
91574616|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||FHA (Post-vaccination GMT; group ratio US1:US2)||1.25|0.85|
91574617|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.04|||||TWO_SIDED|95.0|0.83|1.32|||ANOVA|||Pertactin (Post-vaccination GMT; group ratio US1:US2||1.32|0.83|
91574618|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.96|||||TWO_SIDED|95.0|0.75|1.23|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)||1.23|0.75|
91574619|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.93|1.55|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)||1.55|0.93|
91574620|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.15|||||TWO_SIDED|95.0|0.85|1.56|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)||1.56|0.85|
91574621|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.88||||||95.0|0.65|1.2|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio US1:US2)||1.2|0.65|
91574622|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.31|||||TWO_SIDED|95.0|0.97|1.77|||ANOVA|||HIb (Post-vaccination GMT; group ratio US1:US2)||1.77|0.97|
91574623|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.84|||||TWO_SIDED|95.0|0.7|1.0|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio US1:US2)||1|0.7|
91574624|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.56|1.03|||ANOVA|||PnC 6B (Post-vaccination GMT; group ratio US1:US2)||1.03|0.56|
91574625|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.85||||||95.0|0.7|1.04|||ANOVA|||PnC 9V (Post-vaccination GMT; group ratio US1:US2)||1.04|0.7|
91574626|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26|||ANOVA|||PnC 14 (Post-vaccination GMT; group ratio US1:US2)||1.26|0.84|
91574627|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.77|||||TWO_SIDED|95.0|0.64|0.93|||ANOVA|||PnC 18C (Post-vaccination GMT; group ratio US1:US2)||0.93|0.64|
91574628|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.82|||||TWO_SIDED|95.0|0.69|0.97|||ANOVA|||PnC 19F (Post-vaccination GMT; group ratio US1:US2)||0.97|0.69|
91574629|NCT00474526|183037551|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.79|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 23F (Post-vaccination GMT; group ratio US1:US2)||1.02|0.62|
91574630|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Diphtheria (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
91574631|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Tetanus (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
91574632|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-7.0|12.0|||ANOVA|||PT (Seroconversion percentage difference (PUS1 - PUS2))||12|-7|
91574633|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|6.0|||||TWO_SIDED|95.0|-4.0|17.0|||ANOVA|||FHA(Seroconversion percentage difference (PUS1 - PUS2))||17|-4|
91574634|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-12.0|10.0|||ANOVA|||Pertactin (Seroconversion percentage difference (PUS1 - PUS2))||10|-12|
91574635|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
91574636|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
91574637|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
91574638|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
91574639|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
91574640|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|5.0|||||TWO_SIDED|95.0|-3.0|14.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||14|-3|
91574641|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.0|2.0|||ANOVA|||PnC 4(Seroconversion percentage difference (PUS1 - PUS2))||2|-5|
91574642|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-8.0|||||TWO_SIDED|95.0|-14.0|-1.0|||ANOVA|||PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))||-1|-14|
91574643|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-4.0|5.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PUS1 - PUS2))||5|-4|
91574644|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Diphtheria (Seroconversion percentage di|1.0|||||TWO_SIDED|95.0|-1.0|5.0|||ANOVA|||PnC 14 (Seroconversion percentage difference (PUS1 - PUS2))||5|-1|
91574645|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-6.0|1.0|||ANOVA|||PnC 18C (Seroconversion percentage difference (PUS1 - PUS2))||1|-6|
91574646|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||PnC 19F (Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
91574647|NCT00474526|183037552|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PUS1 - PUS2))||5|-8|
91574648|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.16|||||TWO_SIDED|95.0|0.96|1.4|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.96|
91574649|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.1|||||TWO_SIDED|95.0|0.96|1.27|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.96|
91574650|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||PT (Post-vaccination GMC; group ratio LA1:LA2)||1.25|0.87|
91574651|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.89|1.23|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA1:LA2)||1.23|0.89|
91574652|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.81|1.21|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA1:LA2)||1.21|0.81|
91574653|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.68|1.17|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)||1.17|0.68|
91574654|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.73|1.28|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)||1.28|0.73|
91574655|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.95||||||95.0|0.69|1.31|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)||1.31|0.69|
91574656|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.88|
91574657|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.27|||||TWO_SIDED|95.0|0.98|1.65|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA1:LA2)||1.65|0.98|
91574658|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.92|||||TWO_SIDED|95.0|0.78|1.09|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)||1.09|0.78|
91574659|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.74|1.27|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.74|
91574660|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.71|1.04|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)||1.04|0.71|
91574661|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.72|1.14|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)||1.14|0.72|
91574662|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.74|1.08|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)||1.08|0.74|
91574663|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)||1.1|0.74|
91574664|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.6|0.99|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)||0.99|0.6|
91574665|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.69|0.99|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)||0.99|0.69|
91574666|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.83|1.09|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3:LA4)||1.09|0.83|
91574667|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.93||||||95.0|0.78|1.1|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.78|
91574668|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.75|1.03|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3:LA4)||1.03|0.75|
91574669|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3:LA4||0.97|0.66|
91574670|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.78|||||TWO_SIDED|95.0|0.6|1.02|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)||1.02|0.6|
91574671|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.63|1.09|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)||1.09|0.63|
91574672|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.59|1.11|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)||1.11|0.59|
91574673|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.76|1.19|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)||1.19|0.76|
91574674|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.83|1.37|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA3:LA4)||1.37|0.83|
91574675|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.68|0.95|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)||0.95|0.68|
91574676|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.87|||||TWO_SIDED|95.0|0.67|1.14|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)||1.14|0.67|
91574677|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.83|||||TWO_SIDED|95.0|0.69|1.0|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)||1|0.69|
91574678|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.84||||||95.0|0.67|1.05|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)||1.05|0.67|
91574679|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.62|0.9|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)||0.9|0.62|
91574680|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.75|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.75|
91574681|NCT00474526|183037553|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.69|1.12|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)||1.12|0.69|
91574682|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.2|4.4|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))||4.4|-2.2|
91574683|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.9|2.6|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA1 - PLA2))||2.6|-1.9|
91574684|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-7.7|7.1|||ANOVA|||PT (Seroconversion percentage difference (PLA1 - PLA2))||7.1|-7.7|
91574685|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.2|5.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA1 - PLA2))||5.8|-9.2|
91574686|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-6.0||||||95.0|-12.9|2.2|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA1 - PLA2))||2.2|-12.9|
91574687|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|1.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))||1.0|-4.8|
91574688|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.6|2.3|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))||2.3|-4.6|
91574689|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.2|5.1|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))||5.1|-3.2|
91574690|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.5|3.5|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))||3.5|-1.5|
91574691|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|5.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||5|-1.1|
91574692|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0||||||95.0|-2.8|7.7|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||7.7|-2.8|
91574693|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.3|||ANOVA|||PnC 4(Seroconversion percentage difference (PLA1 - PLA2))||3.3|-3|
91574694|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|4.0|||||TWO_SIDED|95.0|-2.2|12.3|||ANOVA|||PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))||12.3|-2.2|
91574695|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))||3.6|-3.9|
91574696|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|6.2|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))||6.2|-1.1|
91574697|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
91574698|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
91574699|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-4.0|||||TWO_SIDED|95.0|-8.0|1.9|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))||1.9|-8|
91574700|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|3.8|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))||3.8|-2.3|
91574701|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0||||||95.0|-1.3|2.7|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-1.3|
91574702|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.8|10.7|||Seroconversion Percentage difference|||PT (Seroconversion percentage difference (PLA3 - PLA4))||10.7|-4.8|
91574703|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-7.1|8.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA3 - PLA4))||8.8|-7.1|
91574704|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.7|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA3 - PLA4))||5.7|-8|
91574705|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.7|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))||4.7|-2|
91574706|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.8|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))||4.8|-3|
91574707|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.4|4.5|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))||4.5|-4.4|
91574708|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|2.7|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-2.3|
91574709|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.3|1.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||1|-5.3|
91574710|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0||||||95.0|-6.6|3.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||3|-6.6|
91574711|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.2|3.0|||ANOVA|||PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))||3|-4.2|
91574712|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.0|9.0|||ANOVA|||PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))||9|-4|
91574713|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-2.8|6.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))||6|-2.8|
91574714|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|3.4|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))||3.4|-3.7|
91574715|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-7.2|0.8|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))||0.8|-7.2|
91574716|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-0.8|7.5|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))||7.5|-0.8|
91574717|NCT00474526|183037554|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0||||||95.0|-3.7|7.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))||7|-3.7|
91574718|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
91574719|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)||1.02|0.62|
91574720|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
91574721|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.03|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)||1.03|0.63|
91574722|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.78|1.34|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.78|
91574723|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.04||||||95.0|0.81|1.34|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.81|
91574724|NCT00474526|183037569|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.69|1.29|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)||1.29|0.69|
91574725|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|1.0|||||TWO_SIDED|95.0|-8.0|10.0|||ANOVA|||PnC 4 (percentage difference (US1A - US1B))||10|-8|
91574726|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||PnC 6B (percentage difference (US1A - US1B))||10|0|
91574727|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-4.0|||||TWO_SIDED|95.0|-13.0|5.0|||ANOVA|||PnC 9V (percentage difference (US1A - US1B))||5|-13|
91574728|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||ANOVA|||PnC 14 (percentage difference (US1A - US1B))||3|-6|
91574729|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-6.0|||||TWO_SIDED|95.0|-15.0|3.0|||ANOVA|||PnC 18C (percentage difference (US1A:US1B))||3|-15|
91574730|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|-4.0|11.0|||ANOVA|||PnC 19F (percentage difference (US1A:US1B))||11|-4|
91574731|NCT00474526|183037570|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||PnC 239F (percentage difference (US1A:US1B))||5|-10|
91574732|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)||1.02|0.61|
91574733|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.54|1.2|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)||1.2|0.54|
91574734|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.58|0.94|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)||0.94|0.58|
91574735|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.51|0.82|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)||0.82|0.51|
91574736|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.6|1.01|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.6|
91574737|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.56|1.04|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.04|0.56|
91574738|NCT00474526|183037571|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.54|1.01|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.54|
91574739|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.6|5.2|||ANOVA|||PnC 4 (percentage difference (LA1A - LA1B))||5.2|-9.6|
91574740|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-11.9|7.3|||ANOVA|||PnC 6B (percentage difference (LA1A - LA1B))||7.3|-11.9|
91574741|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.9|4.3|||ANOVA|||PnC 9V (percentage difference (LA1A - LA1B))||4.3|-10.9|
91574742|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-5.6|2.7|||ANOVA|||PnC 14 (percentage difference (LA1A - LA1B))||2.7|-5.6|
91574743|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-14.0|||||TWO_SIDED|95.0|-24.1|-5.6|||ANOVA|||PnC 18C (percentage difference (LA1A - LA1B))||-5.6|-24.1|
91574744|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-11.6|5.2|||ANOVA|||PnC 19F (percentage difference (LA1A - LA1B))||5.2|-11.6|
91574745|NCT00474526|183037572|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||ANOVA|||PnC 23F (percentage difference (LA1A - LA1B))||7|-7|
91574746|NCT00474526|183037573|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.86|1.27|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)||1.27|0.86|
91574747|NCT00474526|183037573|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)||1.18|0.75|
91574748|NCT00474526|183037573|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3A:LA3B)||1.4|0.88|
91574749|NCT00474526|183037573|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.9|1.44|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3A:LA3B)||1.44|0.9|
91574750|NCT00474526|183037573|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.21|||||TWO_SIDED|95.0|0.92|1.59|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B||1.59|0.92|
91574751|NCT00474526|183037573|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.63|1.16|||ANOVA|||Hib (Post-vaccination GMC; group ratio LA3A:LA3B)||1.16|0.63|
91574752|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0||||||95.0|-4.2|5.4|||ANOVA|||Diphtheria (percentage difference (LA3A - LA3B))||5.4|-4.2|
91574753|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-4.2|5.4|||ANOVA|||Tetanus (percentage difference (LA3A - LA3B))||5.4|-4.2|
91574754|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|6.0||||||95.0|-3.6|15.2|||ANOVA|||PT (percentage difference (LA3A - LA3B))||15.2|-3.6|
91574755|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|-1.0|||||TWO_SIDED|95.0|-10.2|8.2|||ANOVA|||FHA (percentage difference (LA3A - LA3B))||8.2|-10.2|
91574756|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|2.0|||||TWO_SIDED|95.0|-7.2|10.6|||ANOVA|||Pertactin (percentage difference (LA3A - LA3B))||10.6|-7.2|
91574757|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.1|3.6|||ANOVA|||Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))||3.6|-3.1|
91574758|NCT00474526|183037574|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.2|5.3|||ANOVA|||Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))||5.3|-2.2|
91574759|NCT00132678|183037577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.001||95.0|0.27|0.59|||Log Rank|Adjusting for country|RISPERDAL CONSTA hazard in numerator, placebo hazard in denominator.|||0.59|0.27|<0.001
91574760|NCT00132678|183037578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.09|<|0.001||95.0|-8.08|-3.79|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-3.79|-8.08|<0.001
91574761|NCT00132678|183037579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.02||95.0|-3.75|-0.32|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-0.32|-3.75|0.020
91574762|NCT00953147|183037580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||1.04|0.35|<0.0001
91574763|NCT00953147|183037580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54||||0.0005|TWO_SIDED|95.0|0.24|0.84||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||0.84|0.24|0.0005
91574764|NCT00953147|183037581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0014|TWO_SIDED|95.0|0.25|0.92|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.92|0.25|0.0014
91574765|NCT00953147|183037581|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.42||||0.0122|TWO_SIDED|95.0|0.12|0.72|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.72|0.12|0.0122
91574766|NCT01251770|183037598|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Serum Sodium difference at the beginning||||0.030
91574767|NCT01251770|183037598|SUPERIORITY_OR_OTHER|||||||0.871||95.0|||||t-test, 2 sided|||Serum Sodium at the end of the study||||0.871
91574768|NCT01251770|183037599|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.895
91574769|NCT03299049|183037611|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.|Adjusted difference|0.8|||||TWO_SIDED|95.0|-0.6|2.2|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \>=50 c/mL between each treatment group (Q8W - Q4W) and corresponding 95% CI is presented.|||2.2|-0.6|
91574770|NCT03299049|183037612|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%|Adjusted difference|0.8|||||TWO_SIDED|95.0|-2.1|3.7|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \<50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.|||3.7|-2.1|
91574771|NCT01901419|183037659|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||||||0.618
91574772|NCT01901419|183037660|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.410
91574773|NCT01901419|183037661|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
91574774|NCT01901419|183037662|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
91574775|NCT01901419|183037663|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||||||0.512
91574776|NCT01901419|183037664|SUPERIORITY|||||||0.144|||||||t-test, 2 sided|||||||0.144
91574777|NCT01901419|183037665|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
91574778|NCT01901419|183037666|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
91574779|NCT01901419|183037667|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
91574780|NCT01901419|183037668|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
91574781|NCT01901419|183037669|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91574782|NCT01901419|183037670|SUPERIORITY|||||||0.227|||||||t-test, 2 sided|||||||0.227
91574783|NCT01901419|183037671|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
91574784|NCT01901419|183037672|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91574785|NCT01901419|183037673|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
91574786|NCT01901419|183037674|SUPERIORITY|||||||0.948|||||||t-test, 2 sided|||||||0.948
91574787|NCT01901419|183037675|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||||||0.682
91574788|NCT01901419|183037676|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||0.928
91574789|NCT01901419|183037677|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
91574790|NCT01901419|183037678|SUPERIORITY|||||||0.894|||||||t-test, 2 sided|||||||0.894
91574791|NCT01901419|183037679|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
91574792|NCT01901419|183037680|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||0.038
91574793|NCT01901419|183037681|SUPERIORITY|||||||0.852|||||||t-test, 2 sided|||||||0.852
91574794|NCT01901419|183037682|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||||||0.454
91574795|NCT01901419|183037683|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||||||0.663
91574796|NCT01901419|183037684|SUPERIORITY|||||||0.872|||||||t-test, 2 sided|||||||0.872
91574797|NCT01901419|183037685|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|||||||0.318
91574798|NCT01901419|183037686|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|||||||0.365
91574799|NCT01901419|183037687|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||||||0.077
91574800|NCT01901419|183037688|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.640
91574801|NCT00475644|183037693|SUPERIORITY||Odds Ratio (OR)|0.031|||||TWO_SIDED|95.0|0.001|0.86||||||||0.860|0.001|
91574802|NCT00790400|183037701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
91574803|NCT02412735|183037731|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2072.|||
91574804|NCT02412735|183037731|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.6427.|||
91574805|NCT02412735|183037732|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2754.|||
91574806|NCT02412735|183037732|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.9087.|||
91574807|NCT02412735|183037733|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2835.|||
91574808|NCT02412735|183037733|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.4739.|||
91574809|NCT02412735|183037734|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2650.|||
91574810|NCT02412735|183037734|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.7004.|||
91574811|NCT02412735|183037735|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1945.|||
91574812|NCT02412735|183037735|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.8093.|||
91574813|NCT02412735|183037736|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7842|TWO_SIDED|95.0|0.5|2.46|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% confidence interval (CI) were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.46|0.50|0.7842
91574814|NCT02412735|183037736|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8754|TWO_SIDED|95.0|0.41|2.14|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% CI were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.14|0.41|0.8754
91574815|NCT02412735|183037737|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2309.|||
91574816|NCT02412735|183037737|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1241.|||
91574817|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.08||0.9072|TWO_SIDED|95.0|-5.71|6.43|||Mixed Model for Repeated Measures (MMRM)|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||6.43|-5.71|0.9072
91574818|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|3.14||0.2883|TWO_SIDED|95.0|-9.51|2.83|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||2.83|-9.51|0.2883
91574819|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|3.23||0.6314|TWO_SIDED|95.0|-7.9|4.8|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||4.80|-7.90|0.6314
91574820|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.29||0.1366|TWO_SIDED|95.0|-11.37|1.56|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||1.56|-11.37|0.1366
91574821|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.34||0.2497|TWO_SIDED|95.0|-10.43|2.72|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||2.72|-10.43|0.2497
91574822|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|3.42||0.0666|TWO_SIDED|95.0|-13.0|0.43|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||0.43|-13.00|0.0666
91574823|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.4||0.2147|TWO_SIDED|95.0|-10.91|2.46|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||2.46|-10.91|0.2147
91574824|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.47||0.0162|TWO_SIDED|95.0|-15.19|-1.55|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||-1.55|-15.19|0.0162
91574825|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|3.67||0.223|TWO_SIDED|95.0|-11.69|2.74|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||2.74|-11.69|0.2230
91574826|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.74||0.1152|TWO_SIDED|95.0|-13.27|1.45|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||1.45|-13.27|0.1152
91574827|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|3.66||0.4884|TWO_SIDED|95.0|-9.75|4.67|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||4.67|-9.75|0.4884
91574828|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.74||0.0426|TWO_SIDED|95.0|-14.98|-0.25|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||-0.25|-14.98|0.0426
91574829|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.77||0.3056|TWO_SIDED|95.0|-11.27|3.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||3.54|-11.27|0.3056
91574830|NCT02412735|183037738|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.85||0.1184|TWO_SIDED|95.0|-13.59|1.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||1.54|-13.59|0.1184
91574831|NCT01006980|183037745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.55|||Log Rank||The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.|The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.||0.55|0.26|<0.0001
91574832|NCT01006980|183037746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.33|||Log Rank||Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.|The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).||0.33|0.20|<.0001
91574833|NCT00078338|183037753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.943||||0.643|TWO_SIDED|95.0|0.74|1.21|||Cox proportional hazards model|||||1.21|0.74|0.643
91574834|NCT03445533|183037785|SUPERIORITY|||||||0.9394||||||p-value was calculated for percentage difference (B-A) using a Cochran-Mantel-Haenszel (CMH) test stratified by metastasis stage and BRAF mutation.|Cochran-Mantel-Haenszel|ORR and OS comprise a primary endpoint family; both have a priori hypotheses and were tested for statistical significance.||The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.||||0.9394
91574835|NCT03445533|183037786|SUPERIORITY||Cox Proportional Hazard|0.955||||0.6775|TWO_SIDED|95.0|0.77|1.186||The p-value was calculated using the log rank test stratified by metastasis stage and BRAF mutation.|Log Rank|ORR and OS comprise a primary endpoint family; both have a priori hypotheses. ORR will be tested first followed by OS.|Hazard ratio and 95% CI (B/A) are estimated using a Cox proportional hazards model stratified by metastasis stage and BRAF mutation.|||1.186|0.770|0.6775
91574836|NCT03334253|183037792|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.02|||||TWO_SIDED|95.0|-0.19|0.15|||||Atropine - Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.15|-0.19|
91574837|NCT03334253|183037793|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||||Atropine-Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.17|-0.25|
91574838|NCT01294397|183037826|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.96|||||TWO_SIDED|90.0|0.85|1.08|||||Two one-sided tests|Log-transformed AUC0-168 was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.08|0.85|
91574839|NCT01294397|183037827|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.92|||||TWO_SIDED|90.0|0.81|1.05|||||Two one-sided tests|Log-transformed Cmax was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.05|0.81|
91574840|NCT01762904|183037831|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91574841|NCT01762904|183037832|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91574842|NCT01762904|183037833|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91574843|NCT00609947|183037835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|21.8|<|0.001|ONE_SIDED|95.0||||"The null and alternative hypotheses were:~H0: µSVS ≥µM H1: µSVS \< µM where µSVS was the mean in-segment 8-month percent diameter stenosis for the SVS study and µM was the mean in-segment 6-month percent diameter stenosis for Micro-Driver."|t-test, 2 sided|The sample size was not reduced below 158 evaluable subjects in order to support the analysis of the primary safety endpoint.||The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.||||<0.001
91574844|NCT00609947|183037836|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.0041|ONE_SIDED|95.0||20.0|||t-test, 1 sided|||"The null and alternative hypotheses of interest are:~H0: xSVS \>= 20% vs. H1: xSVS \< 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%."||20||0.0041
91574845|NCT00422734|183037899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
91574846|NCT00422734|183037900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
91574847|NCT00422734|183037900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
91574848|NCT00422734|183037901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574849|NCT00422734|183037902|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574850|NCT00422734|183037903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for subject scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
91574851|NCT00422734|183037903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for partner scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
91574852|NCT00422734|183037904|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
91574853|NCT00422734|183037904|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
91574854|NCT00422734|183037905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 4|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574855|NCT00422734|183037905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 5|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574856|NCT00422734|183037906|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574857|NCT00422734|183037907|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574858|NCT00422734|183037908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
91574859|NCT00422734|183037908|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
91574860|NCT00422734|183037909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
91574861|NCT00422734|183037909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
91574862|NCT00422734|183037910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 1|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574863|NCT00422734|183037910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 2|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574864|NCT00422734|183037911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Total Score|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574865|NCT00422734|183037911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Sexual Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574866|NCT00422734|183037911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Confidence|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574867|NCT00422734|183037912|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Self-Esteem|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574868|NCT00422734|183037912|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Overall Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
91574869|NCT02097303|183037917|OTHER||||||<|1e-05||||||Comparison of ALP levels before and after treatment|t-test, 2 sided|||||||<.00001
91574870|NCT02097303|183037917|OTHER|||||||0.487||||||Comparison of PSA levels before and after treatment|t-test, 2 sided|||||||0.4870
91574871|NCT02975102|183037931|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-101 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.2|0.3|||||Treatment difference : CBL-101 - Vismed Multi|||0.3|-1.2|
91574872|NCT02975102|183037932|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574873|NCT02975102|183037933|SUPERIORITY|||||||0.0002||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0002
91574874|NCT02975102|183037934|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574875|NCT02975102|183037935|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574876|NCT02975102|183037936|SUPERIORITY|||||||0.0186||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0186
91574877|NCT02975102|183037937|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574878|NCT02975102|183037938|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574879|NCT02975102|183037939|SUPERIORITY|||||||0.0011||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0011
91574880|NCT02975102|183037940|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574881|NCT02975102|183037941|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
91574882|NCT02975102|183037942|SUPERIORITY|||||||0.005||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.005
91574883|NCT02975102|183037943|SUPERIORITY|||||||0.0008||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0008
91574884|NCT02975102|183037944|SUPERIORITY|||||||0.0026||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0026
91574885|NCT02975102|183037945|SUPERIORITY|||||||0.077||||||Significance level of 0.05 . P-Value result provided only for Global Question|ANCOVA|Adjustment for baseline||||||0.077
91574886|NCT02975102|183037946|SUPERIORITY|||||||0.6097||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.6097
91574887|NCT02975102|183037947|SUPERIORITY|||||||0.231||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.231
91574888|NCT02975102|183037948|SUPERIORITY|||||||0.0135||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0135
91574889|NCT02975102|183037949|SUPERIORITY|||||||0.575||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.575
91574890|NCT05262751|183037972|OTHER||gMean Ratio|16.69|||||TWO_SIDED|90.0|7.28|38.24|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.24|7.28|
91574891|NCT05262751|183037972|OTHER||gMean Ratio|13.54|||||TWO_SIDED|90.0|8.1|22.64|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||22.64|8.10|
91574892|NCT05262751|183037972|OTHER||gMean Ratio|41.8|||||TWO_SIDED|90.0|34.24|51.04|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||51.04|34.24|
91574893|NCT05262751|183037972|OTHER||gMean Ratio|42.91|||||TWO_SIDED|90.0|34.9|52.76|||||gMean Ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||52.76|34.90|
91574894|NCT05262751|183037973|OTHER||gMean Ratio|9.36|||||TWO_SIDED|90.0|5.91|14.8|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||14.80|5.91|
91574895|NCT05262751|183037973|OTHER||gMean Ratio|12.41|||||TWO_SIDED|90.0|7.93|19.43|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||19.43|7.93|
91574896|NCT05262751|183037973|OTHER||gMean Ratio|37.9|||||TWO_SIDED|90.0|29.25|49.11|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||49.11|29.25|
91574897|NCT05262751|183037973|OTHER||gMean Ratio|35.89|||||TWO_SIDED|90.0|27.66|46.55|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||46.55|27.66|
91574898|NCT05262751|183037974|OTHER||gMean Ratio|12.09|||||TWO_SIDED|90.0|6.73|21.71|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||21.71|6.73|
91574899|NCT05262751|183037974|OTHER||gMean Ratio|23.94|||||TWO_SIDED|90.0|13.51|42.42|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||42.42|13.51|
91574900|NCT05262751|183037974|OTHER||gMean Ratio|68.55|||||TWO_SIDED|90.0|50.07|93.86|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||93.86|50.07|
91574901|NCT05262751|183037974|OTHER||gMean Ratio|66.85|||||TWO_SIDED|90.0|48.77|91.64|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||91.64|48.77|
91574902|NCT05262751|183037975|OTHER||gMean Ratio|11.96|||||TWO_SIDED|90.0|8.88|16.11|||||gMean ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||16.11|8.88|
91574903|NCT05262751|183037975|OTHER||gMean Ratio|13.98|||||TWO_SIDED|90.0|10.59|18.46|||||gMean ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||18.46|10.59|
91574904|NCT05262751|183037975|OTHER||gMean Ratio|32.13|||||TWO_SIDED|90.0|26.46|39.01|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||39.01|26.46|
91574905|NCT05262751|183037975|OTHER||gMean Ratio|31.38|||||TWO_SIDED|90.0|25.71|38.3|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.30|25.71|
91574906|NCT00594022|183037976|SUPERIORITY_OR_OTHER|||||||0.1275|||||||t-test, 1 sided|||||||.1275
91574907|NCT03519204|183038010|SUPERIORITY||Responder Rate Difference|84.7|||<|0.0001|TWO_SIDED|95.0|68.2|94.2||P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.|Fisher Exact|||||94.2|68.2|<0.0001
91574908|NCT03519204|183038012|SUPERIORITY||Median Difference|0.558|STANDARD_ERROR_OF_MEAN|0.109492|<|0.0001|TWO_SIDED|95.0|0.3447|0.7739||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||0.77390|0.34470|<0.0001
91574909|NCT03519204|183038013|SUPERIORITY||Median Difference|13.04|STANDARD_ERROR_OF_MEAN|2.122|<|0.0001|TWO_SIDED|95.0|8.861|17.18||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||17.180|8.861|<0.0001
91574910|NCT03392168|183038021|SUPERIORITY||Least squares mean difference|-28.5||||0.0007|TWO_SIDED|95.0|-44.6|-12.4|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-12.4|-44.6|0.0007
91574911|NCT03392168|183038021|SUPERIORITY||Least squares mean difference|-27.8||||0.0011|TWO_SIDED|95.0|-44.2|-11.5|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-11.5|-44.2|0.0011
91574912|NCT03392168|183038022|SUPERIORITY||Least squares mean difference|-3.2||||0.5493|TWO_SIDED|95.0|-13.7|7.3|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.3|-13.7|0.5493
91574913|NCT03392168|183038022|SUPERIORITY||Least squares mean difference|-4.9||||0.365|TWO_SIDED|95.0|-15.7|5.9|||Mixed Models Analysis|||At week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.9|-15.7|0.3650
91574914|NCT03392168|183038022|SUPERIORITY||Least squares mean difference|-18.3||||0.0064|TWO_SIDED|95.0|-31.3|-5.3|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-5.3|-31.3|0.0064
91574915|NCT03392168|183038022|SUPERIORITY||Least squares mean difference|-19.8||||0.0039|TWO_SIDED|95.0|-33.0|-6.5|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.5|-33.0|0.0039
91574916|NCT03392168|183038022|SUPERIORITY||Least squares mean difference|-28.9||||0.0001|TWO_SIDED|95.0|-42.9|-14.8|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-14.8|-42.9|0.0001
91574917|NCT03392168|183038022|SUPERIORITY||Least squares mean difference|-23.0||||0.0019|TWO_SIDED|95.0|-37.3|-8.7|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-8.7|-37.3|0.0019
91574918|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-4.3||||0.3626|TWO_SIDED|95.0|-13.6|5.0|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.0|-13.6|0.3626
91574919|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-8.1||||0.1011|TWO_SIDED|95.0|-17.8|1.6|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||1.6|-17.8|0.1011
91574920|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-15.5||||0.0017|TWO_SIDED|95.0|-25.1|-6.0|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.0|-25.1|0.0017
91574921|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-19.3||||0.0002|TWO_SIDED|95.0|-29.1|-9.4|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-9.4|-29.1|0.0002
91574922|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-21.3||||0.0003|TWO_SIDED|95.0|-32.4|-10.2|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.2|-32.4|0.0003
91574923|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-21.8||||0.0003|TWO_SIDED|95.0|-33.2|-10.4|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.4|-33.2|0.0003
91574924|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-18.7||||0.001|TWO_SIDED|95.0|-29.5|-7.8|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-7.8|-29.5|0.0010
91574925|NCT03392168|183038023|SUPERIORITY||Least squares mean difference|-21.8||||0.0002|TWO_SIDED|95.0|-32.9|-10.6|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.6|-32.9|0.0002
91574926|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|2.67||||0.3209|TWO_SIDED|95.0|-2.65|7.99|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.99|-2.65|0.3209
91574927|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|3.6||||0.1947|TWO_SIDED|95.0|-1.88|9.08|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||9.08|-1.88|0.1947
91574928|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|-4.58||||0.3561|TWO_SIDED|95.0|-14.4|5.24|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.24|-14.40|0.3561
91574929|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|-5.82||||0.249|TWO_SIDED|95.0|-15.79|4.16|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.16|-15.79|0.2490
91574930|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|-12.68||||0.0276|TWO_SIDED|95.0|-23.992|-1.44|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.44|-23.992|0.0276
91574931|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|-7.04||||0.2223|TWO_SIDED|95.0|-18.44|4.36|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.36|-18.44|0.2223
91574932|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|-20.27||||0.0108|TWO_SIDED|95.0|-35.72|-4.82|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-4.82|-35.72|0.0108
91574933|NCT03392168|183038024|SUPERIORITY||Least squares mean difference|-16.67||||0.0372|TWO_SIDED|95.0|-32.34|-1.01|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.01|-32.34|0.0372
91574934|NCT01441635|183038025|SUPERIORITY||LS Mean Difference|-205.9|STANDARD_ERROR_OF_MEAN|45.1|<|0.001|TWO_SIDED|95.0|-295.77|-116.01|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-116.01|-295.77|< 0.001
91574935|NCT01441635|183038025|SUPERIORITY||LS Mean Difference|-189.9|STANDARD_ERROR_OF_MEAN|44.36|<|0.001|TWO_SIDED|95.0|-278.33|-101.53|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-101.53|-278.33|< 0.001
91574936|NCT01441635|183038025|SUPERIORITY||LS Mean Difference|-138.0|STANDARD_ERROR_OF_MEAN|40.86||0.001|TWO_SIDED|95.0|-220.18|-55.76|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-55.76|-220.18|0.001
91574937|NCT01441635|183038025|SUPERIORITY||LS Mean Difference|-130.6|STANDARD_ERROR_OF_MEAN|37.68||0.001|TWO_SIDED|95.0|-206.7|-54.6|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-54.60|-206.70|0.001
91574938|NCT01441635|183038026|SUPERIORITY||LS Mean Difference|-75.6|STANDARD_ERROR_OF_MEAN|13.71|<|0.001|TWO_SIDED|95.0|-102.93|-48.28|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-48.28|-102.93|< 0.001
91574939|NCT01441635|183038026|SUPERIORITY||LS Mean Difference|-64.27|STANDARD_ERROR_OF_MEAN|13.48|<|0.001|TWO_SIDED|95.0|-91.14|-37.39|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-37.39|-91.14|< 0.001
91574940|NCT01441635|183038026|SUPERIORITY||LS Mean Difference|-67.67|STANDARD_ERROR_OF_MEAN|22.73||0.005|TWO_SIDED|95.0|-113.39|-21.96|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-21.96|-113.39|0.005
91574941|NCT01441635|183038026|SUPERIORITY||LS mean Difference|-56.84|STANDARD_ERROR_OF_MEAN|8.12|<|0.001|TWO_SIDED|95.0|-73.24|-40.45|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-40.45|-73.24|< 0.001
91574942|NCT01441635|183038027|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574943|NCT01441635|183038027|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574944|NCT01441635|183038027|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574945|NCT01441635|183038027|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574946|NCT01441635|183038028|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574947|NCT01441635|183038028|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574948|NCT01441635|183038028|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574949|NCT01441635|183038028|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574950|NCT01441635|183038029|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574951|NCT01441635|183038029|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574952|NCT01441635|183038029|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574953|NCT01441635|183038029|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574954|NCT01441635|183038031|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.97|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|0.97|< 0.001
91574955|NCT01441635|183038031|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.0|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|1.00|< 0.001
91574956|NCT01441635|183038031|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.4||0.024|TWO_SIDED|95.0|0.13|1.75|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.75|0.13|0.024
91574957|NCT01441635|183038031|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.28|1.51|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.51|0.28|0.005
91574958|NCT01441635|183038032|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.14||0.011|TWO_SIDED|95.0|-0.63|-0.08|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.08|-0.63|0.011
91574959|NCT01441635|183038032|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.03|-0.59|0.030
91574960|NCT01441635|183038032|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.109|TWO_SIDED|95.0|-0.59|0.06|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||0.06|-0.59|0.109
91574961|NCT01441635|183038032|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.002|TWO_SIDED|95.0|-0.8|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-0.80|0.002
91574962|NCT01441635|183038033|SUPERIORITY||LS Mean Difference|-10.29|STANDARD_ERROR_OF_MEAN|4.32||0.02|TWO_SIDED|95.0|-18.9|-1.67|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.67|-18.90|0.020
91574963|NCT01441635|183038033|SUPERIORITY||LS Mean Difference|-7.62|STANDARD_ERROR_OF_MEAN|4.39||0.087|TWO_SIDED|95.0|-16.36|1.13|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.13|-16.36|0.087
91574964|NCT01441635|183038033|SUPERIORITY||LS Mean Difference|-8.81|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.43|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-17.43|0.045
91574965|NCT01441635|183038033|SUPERIORITY||LS Mean Difference|-13.69|STANDARD_ERROR_OF_MEAN|4.14||0.002|TWO_SIDED|95.0|-22.06|-5.32|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-5.32|-22.06|0.002
91574966|NCT01441635|183038034|SUPERIORITY||LS Mean Difference|-5.51|STANDARD_ERROR_OF_MEAN|2.03||0.008|TWO_SIDED|95.0|-9.56|-1.47|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.47|-9.56|0.008
91574967|NCT01441635|183038034|SUPERIORITY||LS Mean Difference|-4.95|STANDARD_ERROR_OF_MEAN|2.08||0.02|TWO_SIDED|95.0|-9.11|-0.8|||ANCOVA|||||-0.80|-9.11|0.020
91574968|NCT01441635|183038034|SUPERIORITY||LS Mean Difference|-3.63|STANDARD_ERROR_OF_MEAN|2.75||0.194|TWO_SIDED|95.0|-9.18|1.91|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.91|-9.18|0.194
91574969|NCT01441635|183038034|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-11.33|-3.07|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-3.07|-11.33|0.001
91574970|NCT01441635|183038037|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
91574971|NCT01441635|183038037|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
91574972|NCT01441635|183038037|SUPERIORITY|||||||0.052|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.052
91574973|NCT01441635|183038037|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
91574974|NCT01441635|183038038|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
91574975|NCT01441635|183038038|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
91574976|NCT01441635|183038038|SUPERIORITY|||||||0.012|||||||Fisher Exact|||||||0.012
91574977|NCT01441635|183038038|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
91574978|NCT01441635|183038039|SUPERIORITY|||||||0.161|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor||||||0.161
91574979|NCT01441635|183038039|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.173
91574980|NCT01441635|183038039|SUPERIORITY|||||||0.072|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.072
91574981|NCT01441635|183038039|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.003
91574982|NCT01441635|183038040|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
91574983|NCT01441635|183038040|SUPERIORITY|||||||0.342|||||||Fisher Exact|||||||0.342
91574984|NCT01441635|183038040|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||0.038
91574985|NCT01441635|183038040|SUPERIORITY|||||||0.111|||||||Fisher Exact|||||||0.111
91574986|NCT02627118|183038045|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
91574987|NCT01154140|183038049|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.454|||<|0.0001|TWO_SIDED|95.0|0.346|0.596||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group performance status (ECOG PS),race,brain metastases. 1-sided log-rank test at 0.0247 level of significance was used to compare PFS between the 2 arms.|Log Rank|||||0.596|0.346|<0.0001
91574988|NCT01154140|183038050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0489|TWO_SIDED|95.0|0.548|1.053||P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.|Log Rank||HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.|||1.053|0.548|0.0489
91574989|NCT01154140|183038052|SUPERIORITY_OR_OTHER||Difference in Percentage|29.4|||<|0.0001|TWO_SIDED|95.0|19.5|39.3||P-value was obtained from a Pearson chi-square test.|Pearson chi-square test||95% CI was calculated based on normal distribution.|If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.||39.3|19.5|<0.0001
91574990|NCT01154140|183038055|SUPERIORITY_OR_OTHER||Difference in Percentage|10.067||||0.0381|TWO_SIDED|95.0|0.8|19.4|||Pearson chi-square test|||The confidence interval for the difference in percentage was based on normal distribution.||19.4|0.8|0.0381
91574991|NCT01154140|183038056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.335|0.582||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR \<1 indicated a reduction in hazard rate in favor of Crizotinib.||0.582|0.335|<0.0001
91574992|NCT01154140|183038057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.0347|TWO_SIDED|95.0|0.338|1.048||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||1.048|0.338|0.0347
91574993|NCT01154140|183038058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.286|0.524||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||0.524|0.286|<0.0001
91574994|NCT01154140|183038065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.591||||0.0002|TWO_SIDED|95.0|0.452|0.773||Two-sided p-value from the unstratified log rank test was used.|Log Rank|||HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.||0.773|0.452|0.0002
91574995|NCT01154140|183038066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.8303|||<|0.0001|TWO_SIDED|95.0|10.74|16.92|||Mixed Models Analysis|||QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.92|10.74|<0.0001
91574996|NCT01154140|183038066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3532||||0.017|TWO_SIDED|95.0|0.6|6.11|||Mixed Models Analysis|||QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||6.11|0.60|0.0170
91574997|NCT01154140|183038066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5165|||<|0.0001|TWO_SIDED|95.0|4.57|10.46|||Mixed Models Analysis|||QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||10.46|4.57|<0.0001
91574998|NCT01154140|183038066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4035|||<|0.0001|TWO_SIDED|95.0|7.48|13.32|||Mixed Models Analysis|||QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||13.32|7.48|<0.0001
91574999|NCT01154140|183038066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.5513|||<|0.0001|TWO_SIDED|95.0|11.29|19.81|||Mixed Models Analysis|||QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||19.81|11.29|<0.0001
91575000|NCT01154140|183038066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7641|||<|0.0001|TWO_SIDED|95.0|4.69|12.84|||Mixed Models Analysis|||QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||12.84|4.69|<0.0001
91575001|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.4976|||<|0.0001|TWO_SIDED|95.0|-18.03|-8.97|||Mixed Models Analysis|||QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-8.97|-18.03|<0.0001
91575002|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4336||||0.057|TWO_SIDED|95.0|-9.0|0.13|||Mixed Models Analysis|||QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||0.13|-9.00|0.0570
91575003|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4906|||<|0.0001|TWO_SIDED|95.0|8.98|16.0|||Mixed Models Analysis|||QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.00|8.98|<0.0001
91575004|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.4622|||<|0.0001|TWO_SIDED|95.0|-17.2|-9.73|||Mixed Models Analysis|||QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-9.73|-17.20|<0.0001
91575005|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9987|||<|0.0001|TWO_SIDED|95.0|-18.52|-11.48|||Mixed Models Analysis|||QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-11.48|-18.52|<0.0001
91575006|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8186||||0.6681|TWO_SIDED|95.0|-4.56|2.92|||Mixed Models Analysis|||QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||2.92|-4.56|0.6681
91575007|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.043|||<|0.0001|TWO_SIDED|95.0|-14.22|-5.87|||Mixed Models Analysis|||QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-5.87|-14.22|<0.0001
91575008|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4446||||0.0468|TWO_SIDED|95.0|-6.84|-0.05|||Mixed Models Analysis|||QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-0.05|-6.84|0.0468
91575009|NCT01154140|183038067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.9277|||<|0.0001|TWO_SIDED|95.0|-13.23|-6.62|||Mixed Models Analysis|||QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-6.62|-13.23|<0.0001
91575010|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8149||||0.0108|TWO_SIDED|95.0|-8.52|-1.11|||Mixed Models Analysis|||QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-1.11|-8.52|0.0108
91575011|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.3926|||<|0.0001|TWO_SIDED|95.0|-12.06|-4.72|||Mixed Models Analysis|||QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.72|-12.06|<0.0001
91575012|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6651||||0.5938|TWO_SIDED|95.0|-1.78|3.11|||Mixed Models Analysis|||QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||3.11|-1.78|0.5938
91575013|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.008|||<|0.0001|TWO_SIDED|95.0|-11.96|-6.06|||Mixed Models Analysis|||QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-6.06|-11.96|<0.0001
91575014|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8828||||0.0656|TWO_SIDED|95.0|-1.82|0.06|||Mixed Models Analysis|||QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.06|-1.82|0.0656
91575015|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0475||||0.0002|TWO_SIDED|95.0|-9.22|-2.88|||Mixed Models Analysis|||QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-2.88|-9.22|0.0002
91575016|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0959|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.84|||Mixed Models Analysis|||QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.84|-11.35|<0.0001
91575017|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7717||||0.0001|TWO_SIDED|95.0|-10.24|-3.31|||Mixed Models Analysis|||QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-3.31|-10.24|0.0001
91575018|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3521||||0.0427|TWO_SIDED|95.0|0.11|6.59|||Mixed Models Analysis|||QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||6.59|0.11|0.0427
91575019|NCT01154140|183038068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1521||||0.1382|TWO_SIDED|95.0|-5.0|0.69|||Mixed Models Analysis|||QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.69|-5.00|0.1382
91575020|NCT01154140|183038069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9908||||0.0139|TWO_SIDED|95.0|0.81|7.17|||Mixed Models Analysis|||Analysis was based on a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EQ-5D VAS subscale baseline score (intercept and time from first dose were included as random effects).||7.17|0.81|0.0139
91575021|NCT00358644|183038073|SUPERIORITY_OR_OTHER||Percentage of Participants|23.6||||||95.0|13.2|37.0||||||||37.0|13.2|
91575022|NCT00401258|183038092|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
91575023|NCT00401258|183038093|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain severity statistical analysis||||<.001
91575024|NCT00401258|183038093|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain interference statistical analysis||||<.001
91575025|NCT00401258|183038094|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
91575026|NCT00401258|183038095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91575027|NCT00401258|183038097|SUPERIORITY_OR_OTHER|||||||0.031|||||||Mixed Models Analysis|||||||0.031
91575028|NCT00401258|183038098|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
91575029|NCT00401258|183038099|SUPERIORITY_OR_OTHER|||||||0.004||||||Refers to work/school sub-scale|Mixed Models Analysis|||||||0.004
91575030|NCT00401258|183038099|SUPERIORITY_OR_OTHER|||||||0.087||||||Refers to social sub scale|Mixed Models Analysis|||||||0.087
91575031|NCT00401258|183038099|SUPERIORITY_OR_OTHER|||||||0.006||||||Refers to family sub scale|Mixed Models Analysis|||||||0.006
91575032|NCT04944290|183038148|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.71|0.51||||||||0.51|-0.71|
91575033|NCT04944290|183038148|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.86|0.26||||||10AM Day 14||0.26|-0.86|
91575034|NCT04944290|183038148|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.58|0.58||||||||0.58|-0.58|
91575035|NCT04944290|183038148|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.7|0.47||||||||0.47|-0.70|
91575036|NCT01483144|183038212|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.121|TWO_SIDED|95.0|0.4|1.3||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and sulindac plus eflornithine placebo is the denominator.|Intent to treat population with all FAP-related events||1.3|0.4|0.1210
91575037|NCT01483144|183038212|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1076|TWO_SIDED|95.0|0.4|1.2||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and eflornithine plus sulindac placebo is the denominator.|Intent to treat population with all FAP-related events||1.2|0.4|0.1076
91575038|NCT01483144|183038212|SUPERIORITY||Hazard Ratio (HR)|0.2||||0.0201|TWO_SIDED|95.0|0.0|0.8||Threshold for statistical significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and sulindac and eflornithine placebo is the denominator. Reduction in relative risk for FAP-related events with the combination.|Lower GI population||0.8|0.0|0.0201
91575039|NCT01483144|183038212|SUPERIORITY||Hazard Ratio (HR)|0.17||||0.0101|TWO_SIDED|95.0|0.0|0.7||Threshold of significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and eflornithine and sulindac placebo is the denominator.|Lower GI population||0.7|0|0.0101
91575040|NCT01483144|183038213|SUPERIORITY|||||||0.8127||||||The threshold of significance was p=0.05|Mantel Haenszel|||||||0.8127
91575041|NCT01483144|183038213|SUPERIORITY|||||||0.8133||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.8133
91575042|NCT01483144|183038214|SUPERIORITY|||||||0.999||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.999
91575043|NCT01483144|183038214|SUPERIORITY|||||||0.2152||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.2152
91575044|NCT04307940|183038226|SUPERIORITY||LS Mean Difference|14.81||||0.001|TWO_SIDED|95.0|6.1|23.51||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||23.51|6.10|0.001
91575045|NCT04307940|183038226|SUPERIORITY||LS Mean Difference|39.63|||<|0.001|TWO_SIDED|95.0|29.08|50.18||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||50.18|29.08|<0.001
91575046|NCT04307940|183038226|SUPERIORITY||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|14.26|35.39||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||35.39|14.26|<0.001
91575047|NCT04624243|183038239|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-2.8||||0.241|TWO_SIDED|97.5|-8.3|2.6|||ANCOVA|||||2.6|-8.3|0.241
91575048|NCT04624243|183038239|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-0.7||||0.784|TWO_SIDED|97.5|-6.3|4.9|||ANCOVA|||||4.9|-6.3|0.784
91575049|NCT04624243|183038241|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.3||||0.096|TWO_SIDED|97.5|-3.1|0.5|||ANCOVA|||||0.5|-3.1|0.096
91575050|NCT04624243|183038241|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.4||||0.094|TWO_SIDED|97.5|-3.2|0.5|||ANCOVA|||||0.5|-3.2|0.094
91575051|NCT04624243|183038242|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|-0.2||||0.254|TWO_SIDED|97.5|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.254
91575052|NCT04624243|183038242|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|0.0||||0.959|TWO_SIDED|97.5|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.959
91575053|NCT04624243|183038246|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|97.5|-10.4|-6.5|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-6.5|-10.4|<0.001
91575054|NCT04624243|183038246|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-7.3|||<|0.001|TWO_SIDED|97.5|-9.3|-5.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-5.2|-9.3|<0.001
91575055|NCT04624243|183038247|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|97.5|-7.4|-4.6|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.6|-7.4|<0.001
91575056|NCT04624243|183038247|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.0|-4.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.2|-7.0|<0.001
91575057|NCT04896008|183038306|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.43||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||HR and associated 95% confidence interval were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.43|0.13|<0.0001
91575058|NCT04896008|183038307|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0313|TWO_SIDED|95.0|0.17|1.07||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||1.07|0.17|0.0313
91575059|NCT04896008|183038308|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0039|TWO_SIDED|95.0|0.15|0.78||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.78|0.15|0.0039
91575060|NCT04896008|183038309|SUPERIORITY||Treatment Difference|-7.29||||0.135|TWO_SIDED|95.0|-17.65|2.41||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype)|||2.41|-17.65|0.135
91575061|NCT04896008|183038310|SUPERIORITY||Treatment Difference|-3.1|||<|0.001|TWO_SIDED|95.0|-4.25|-1.88||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|||-1.88|-4.25|<0.001
91575062|NCT04896008|183038311|SUPERIORITY||Treatment Difference|33.05|||<|0.001|TWO_SIDED|95.0|18.41|46.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by a randomization stratification factor (PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by a randomization stratification factors (PAH subtype).|||46.98|18.41|<0.001
91575063|NCT04896008|183038312|SUPERIORITY||Treatment Difference|-2339.1|||<|0.001|TWO_SIDED|95.0|-3378.74|-1299.44||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-1299.44|-3378.74|<0.001
91575064|NCT04896008|183038313|SUPERIORITY||Treatment Difference|-21.2|||<|0.001|TWO_SIDED|95.0|-27.78|-14.59||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-14.59|-27.78|<0.001
91575065|NCT04896008|183038314|SUPERIORITY||Treatment Difference|-339.6|||<|0.001|TWO_SIDED|95.0|-511.09|-168.06||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-168.06|-511.09|<0.001
91575066|NCT04896008|183038315|SUPERIORITY||Treatment Difference|27.41|||<|0.001|TWO_SIDED|95.0|12.85|40.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||40.98|12.85|<0.001
91575067|NCT04896008|183038316|SUPERIORITY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|23.22|102.73||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||102.73|23.22|<0.001
91575068|NCT04896008|183038317|SUPERIORITY||Treatment Difference|0.5||||0.119|TWO_SIDED|95.0|-0.18|1.16||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype)|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||1.16|-0.18|0.119
91575069|NCT01810939|183038330|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||||0.81|0.7|
91575070|NCT01810939|183038331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L||||<0.001
91575071|NCT01810939|183038332|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L||||<0.001
91575072|NCT01810939|183038333|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Longitudinal mixed models|Test that the mean change is significantly different from zero.||Estimation of mean change in serum potassium from Part A Baseline to Part A Week 4 and test mean change different from zero.||||<0.001
91575073|NCT01810939|183038334|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Test for difference between treatment groups in serum potassium change in Part B||||< 0.001
91575074|NCT05646719|183038373|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.01|TWO_SIDED|95.0|1.23|4.2|||t-test, 2 sided|||||4.20|1.23|<0.01
91575075|NCT05646719|183038373|SUPERIORITY||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0||||||||||||
91575076|NCT03322540|183038374|SUPERIORITY||Difference in Percentages|-6.5||||0.8|TWO_SIDED|95.0|-21.5|8.7|||Stratified Miettinen and Nurminen method|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Point estimate was assessed based on Miettinen \& Nurminen method stratified by predominant tumor histology (squamous vs non-squamous).|||8.7|-21.5|0.8000
91575077|NCT03926195|183038407|OTHER||Difference in Percentage|5.8|||||TWO_SIDED|95.0|-7.5|19.2|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||19.2|-7.5|
91575078|NCT03926195|183038409|OTHER||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-6.4|3.5|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||3.5|-6.4|
91575079|NCT03926195|183038411|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-37.1|36.8|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||36.8|-37.1|
91575080|NCT03926195|183038413|OTHER||Median Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-6.0|20.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||20.8|-6.0|
91575081|NCT03926195|183038415|OTHER||Median Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.6|0.1|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.1|-0.6|
91575082|NCT03926195|183038417|OTHER||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1|-3|
91575083|NCT03054337|183038419|SUPERIORITY||Least squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.301||0.0045|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|The analysis of covariance (ANCOVA) model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.51|0.29|0.0045
91575084|NCT03054337|183038419|SUPERIORITY||Least squares mean difference|1.59|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|0.98|2.21|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.21|0.98|<0.0001
91575085|NCT03054337|183038419|SUPERIORITY||Least squares mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.49|2.7|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.70|1.49|<0.0001
91575086|NCT03054337|183038425|SUPERIORITY||Least squares mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.103||0.0018|TWO_SIDED|95.0|0.13|0.55|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.55|0.13|0.0018
91575087|NCT03054337|183038425|SUPERIORITY||Least squares mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.103|<|0.0001|TWO_SIDED|95.0|0.3|0.72|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.72|0.30|<0.0001
91575088|NCT03054337|183038425|SUPERIORITY||Least squares mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|0.45|0.86|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.86|0.45|<0.0001
91575089|NCT03054337|183038425|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.005||0.7804|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.01|-0.01|0.7804
91575090|NCT03054337|183038425|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0986|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.0986
91575091|NCT03054337|183038425|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.1661|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.1661
91575092|NCT03054337|183038427|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.942||0.001|TWO_SIDED|95.0|1.4|5.2|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.20|1.40|0.0010
91575093|NCT03054337|183038427|SUPERIORITY||Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|0.953|<|0.0001|TWO_SIDED|95.0|3.38|7.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.22|3.38|<0.0001
91575094|NCT03054337|183038427|SUPERIORITY||Least squares mean difference|7.24|STANDARD_ERROR_OF_MEAN|0.93|<|0.0001|TWO_SIDED|95.0|5.37|9.11|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||9.11|5.37|<0.0001
91575095|NCT03054337|183038427|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.152||0.5889|TWO_SIDED|95.0|-0.39|0.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.22|-0.39|0.5889
91575096|NCT03054337|183038427|SUPERIORITY||Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.151||0.8074|TWO_SIDED|95.0|-0.27|0.34|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.34|-0.27|0.8074
91575097|NCT03054337|183038427|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.36|0.24|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.24|-0.36|0.6952
91575098|NCT03054337|183038429|SUPERIORITY|||||||0.3702|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.3702
91575099|NCT03054337|183038429|SUPERIORITY|||||||0.5524|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.5524
91575100|NCT03054337|183038429|SUPERIORITY|||||||0.1589|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.1589
91575101|NCT03054337|183038429|SUPERIORITY|||||||0.0092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0092
91575102|NCT03054337|183038429|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
91575103|NCT03054337|183038429|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
91575104|NCT03054337|183038431|SUPERIORITY|||||||0.9092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.9092
91575105|NCT03054337|183038431|SUPERIORITY|||||||0.1484|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1484
91575106|NCT03054337|183038431|SUPERIORITY|||||||0.1313|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1313
91575107|NCT03054337|183038433|SUPERIORITY|||||||0.108|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.1080
91575108|NCT03054337|183038433|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0002
91575109|NCT03054337|183038433|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
91575110|NCT03054337|183038433|SUPERIORITY|||||||0.0672|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0672
91575111|NCT03054337|183038433|SUPERIORITY|||||||0.0004|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0004
91575112|NCT03054337|183038433|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||<0.0001
91575113|NCT03054337|183038440|SUPERIORITY|||||||0.0895|||||||Fisher Exact|||||||0.0895
91575114|NCT03054337|183038440|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91575115|NCT03054337|183038440|SUPERIORITY|||||||0.3845|||||||Fisher Exact|||||||0.3845
91575116|NCT02838979|183038452|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.34||0.15|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.15
91575117|NCT02838979|183038453|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_DEVIATION|22.18||0.86|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.86
91575118|NCT02838979|183038454|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_DEVIATION|1.04||0.44|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.44
91575119|NCT02838979|183038455|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.21||0.36|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.36
91575120|NCT02838979|183038456|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|7.87||0.6|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.60
91575121|NCT00874731|183038469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|90.0|-2.8|3.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.76|-2.80|
91575122|NCT00874731|183038472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-3.83|2.74|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.74|-3.83|
91575123|NCT00874731|183038473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-4.5|2.14|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.14|-4.50|
91575124|NCT00874731|183038474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-2.85|3.79|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.79|-2.85|
91575125|NCT00874731|183038475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||||TWO_SIDED|95.0|-2.1|4.47|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|4.47|-2.10|
91575126|NCT00874731|183038476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||||TWO_SIDED|95.0|-0.79|5.78|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.78|-0.79|
91575127|NCT00874731|183038477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-0.8|5.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.76|-0.80|
91575128|NCT00874731|183038478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||||TWO_SIDED|95.0|0.6|7.17|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|7.17|0.60|
91575129|NCT00874731|183038479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-4.85|1.86|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|1.86|-4.85|
91575130|NCT00790205|183038503|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.09|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.09|0.88|<0.001
91575131|NCT00790205|183038504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.08|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.08|0.89|<0.001
91575132|NCT00790205|183038505|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.11|0.89|<0.001
91575133|NCT00790205|183038506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.1|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.10|0.89|<0.001
91575134|NCT00790205|183038507|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.435|TWO_SIDED|95.0|0.91|1.24|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.24|0.91|0.435
91575135|NCT00790205|183038508|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.875|TWO_SIDED|95.0|0.9|1.14|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.14|0.90|0.875
91575136|NCT00790205|183038509|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.81|1.19|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.19|0.81|0.858
91575137|NCT00790205|183038510|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.983|TWO_SIDED|95.0|0.83|1.2|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.20|0.83|0.983
91575138|NCT00790205|183038517|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.001|TWO_SIDED|95.0|0.61|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.61|<0.001
91575139|NCT00790205|183038518|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.79|0.63|<0.001
91575140|NCT00790205|183038519|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.75|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.75|0.65|<0.001
91575141|NCT00790205|183038520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.68|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.68|<0.001
91575142|NCT01993849|183038538|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.69|TWO_SIDED|95.0|-3.81|2.59||The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||||2.59|-3.81|0.69
91575143|NCT00848484|183038576|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.277
91575144|NCT00848484|183038577|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
91575145|NCT00848484|183038578|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.933
91575146|NCT00848484|183038579|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
91575147|NCT00848484|183038580|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|Wilcoxon (Mann-Whitney)|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
91575148|NCT00848484|183038581|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
91575149|NCT02567708|183038583|OTHER||Posterior median difference.|0.007|STANDARD_DEVIATION|0.0468||0.57|TWO_SIDED|95.0|-0.083|0.102||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.102|-0.083|0.57
91575150|NCT02567708|183038584|OTHER||Posterior median difference.|0.013|STANDARD_DEVIATION|0.0501||0.61|TWO_SIDED|95.0|-0.084|0.113||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.113|-0.084|0.61
91575151|NCT02567708|183038585|OTHER|The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Posterior median difference|0.05|STANDARD_DEVIATION|0.0818||0.731|TWO_SIDED|95.0|-0.111|0.21|||Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.210|-0.111|0.731
91575152|NCT02567708|183038586|OTHER||Posterior median difference|-0.009|STANDARD_DEVIATION|0.0712||0.44|TWO_SIDED|95.0|-0.151|0.131||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.131|-0.151|0.44
91575153|NCT02567708|183038586|OTHER||Posterior median difference|0.024|STANDARD_DEVIATION|0.057||0.66|TWO_SIDED|95.0|-0.087|0.137||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.137|-0.087|0.66
91575154|NCT02567708|183038587|OTHER||Posterior median difference|-0.021|STANDARD_DEVIATION|0.0609||0.35|TWO_SIDED|95.0|-0.14|0.099||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.099|-0.140|0.35
91575155|NCT02567708|183038587|OTHER||Posterior median difference|0.04|STANDARD_DEVIATION|0.0578||0.76|TWO_SIDED|95.0|-0.071|0.156||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.156|-0.071|0.76
91575156|NCT02567708|183038587|OTHER||Posterior median difference|0.038|STANDARD_DEVIATION|0.0559||0.76|TWO_SIDED|95.0|-0.073|0.148||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.148|-0.073|0.76
91575157|NCT02567708|183038588|OTHER||Posterior median difference|0.083|STANDARD_DEVIATION|0.6175||0.56|TWO_SIDED|95.0|-1.102|1.346||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.346|-1.102|0.56
91575158|NCT02567708|183038588|OTHER||Posterior median difference|0.014|STANDARD_DEVIATION|0.6672||0.51|TWO_SIDED|95.0|-1.271|1.341||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.341|-1.271|0.51
91575159|NCT02567708|183038588|OTHER||Posterior median difference|-0.113|STANDARD_DEVIATION|0.5148||0.41|TWO_SIDED|95.0|-1.125|0.908||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo..|||0.908|-1.125|0.41
91575160|NCT02567708|183038589|OTHER||Posterior median difference|0.5|STANDARD_DEVIATION|0.59||0.81|TWO_SIDED|95.0|-0.6|1.7||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.7|-0.6|0.81
91575161|NCT02567708|183038592|OTHER||Posterior median ratio|0.89|STANDARD_DEVIATION|0.063||0.97|TWO_SIDED|95.0|0.78|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.00|0.78|0.97
91575162|NCT02567708|183038592|OTHER||Posterior median ratio|0.95|STANDARD_DEVIATION|0.071||0.76|TWO_SIDED|95.0|0.83|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.09|0.83|0.76
91575163|NCT02567708|183038592|OTHER||Posterior median ratio|1.0|STANDARD_DEVIATION|0.085||0.51|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than one.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.18|0.84|0.51
91575164|NCT00706654|183038601|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.|Mean Difference (Final Values)|-0.64||||0.7871|TWO_SIDED|95.0|-5.26|3.99|||z-statistics||The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.|Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.||3.99|-5.26|0.7871
91575165|NCT00706654|183038601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.68||||0.0006|TWO_SIDED|95.0|-23.09|-6.27||Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).|z-statistics|The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.||For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.||-6.27|-23.09|0.0006
91575166|NCT00706654|183038603|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||z-statistics|||||||0.8750
91575167|NCT00706654|183038603|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||z-statistics|||||||0.0001
91575168|NCT00706654|183038604|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||z-statistics|||||||0.3700
91575169|NCT00706654|183038604|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||z-statistics|||||||0.1097
91575170|NCT01151215|183038611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.485|TWO_SIDED|95.0|0.77|1.75||Statistical significance threshold at this interim analysis was 5%|Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \<1 favours AZD8931 40mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||1.75|0.77|0.485
91575171|NCT01151215|183038611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.135|TWO_SIDED|95.0|0.91|2.06|||Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \< 1 favours AZD8931 20mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||2.06|0.91|0.135
91575172|NCT01727505|183038642|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon signed rank test|||||||0.44
91575173|NCT01727505|183038643|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon signed rank test|||||||.75
91575174|NCT01727505|183038644|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
91575175|NCT01727505|183038645|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
91575176|NCT01727505|183038646|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon signed rank test|||||||.049
91575177|NCT01727505|183038647|SUPERIORITY_OR_OTHER|||||||0.006|||||||Paired t-test|||||||0.006
91575178|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575179|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575180|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575181|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575182|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575183|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575184|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575185|NCT01299480|183038671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575186|NCT01299480|183038673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575187|NCT01299480|183038673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575188|NCT01299480|183038673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575189|NCT01299480|183038673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
91575190|NCT04297618|183038720|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91575191|NCT04297618|183038721|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
91575192|NCT03838731|183038724|SUPERIORITY||Hazard Ratio (HR)|0.36|||=|0.0083|TWO_SIDED|95.0|0.17|0.77|||Cox Proportional Hazard|||||0.77|0.17|= 0.0083
91575193|NCT03838731|183038725|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.12|0.48|||Cox Hazard Model|||Day 29||0.48|0.12|< 0.0001
91575194|NCT03838731|183038725|SUPERIORITY||Hazard Ratio (HR)|0.45|||=|0.0222||95.0|0.22|0.89|||Cox Hazard Model|||Day 57||0.89|0.22|= 0.0222
91575195|NCT03838731|183038725|SUPERIORITY||Hazard Ratio (HR)|0.27|||=|0.0003||95.0|0.13|0.56|||Cox Hazard Model|||Day 85||0.56|0.13|= 0.0003
91575196|NCT03838731|183038726|SUPERIORITY|Day 8|LS Mean Difference|13.56|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|6.35|20.77|||MMRM|||||20.77|6.35|<0.001
91575197|NCT03838731|183038726|SUPERIORITY|Day 29|LS Mean Difference|16.21|STANDARD_ERROR_OF_MEAN|4.97|=|0.002|TWO_SIDED|95.0|6.18|26.24|||MMRM|||||26.24|6.18|= 0.002
91575198|NCT03838731|183038726|SUPERIORITY|Day 57|LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.94|=|0.016|TWO_SIDED|95.0|2.4|22.2|||MMRM|||||22.20|2.40|= 0.016
91575199|NCT03838731|183038726|SUPERIORITY|Day 85|LS Mean Difference|12.54|STANDARD_ERROR_OF_MEAN|4.54|=|0.008|TWO_SIDED|95.0|3.43|21.65|||MMRM|||||21.65|3.43|= 0.008
91575200|NCT03838731|183038727|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.21|0.53|||MMRM|||Day 8||0.53|0.21|< 0.001
91575201|NCT03838731|183038727|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.23|0.68|||MMRM|||Day 29||0.68|0.23|<0.001
91575202|NCT03838731|183038727|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.13|0.55|||MMRM|||Day 57||0.55|0.13|= 0.002
91575203|NCT03838731|183038727|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.15|0.47|||MMRM|||Day 85||0.47|0.15|= 0.002
91575204|NCT03838731|183038728|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.53|=|0.675|TWO_SIDED|95.0|-0.85|1.29|||MMRM|||Day 8||1.29|-0.85|= 0.675
91575205|NCT03838731|183038728|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.51|=|0.182|TWO_SIDED|95.0|-1.7|0.33|||MMRM|||Day 29||0.33|-1.70|= 0.182
91575206|NCT03838731|183038728|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61|=|0.866|TWO_SIDED|95.0|-1.12|1.32|||MMRM|||Day 57||1.32|-1.12|= 0.866
91575207|NCT03838731|183038728|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.6|=|0.146|TWO_SIDED|95.0|-2.08|0.32|||MMRM|||Day 85||0.32|-2.08|= 0.146
91575208|NCT03838731|183038729|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.24|=|0.572|TWO_SIDED|95.0|-0.35|0.63|||MMRM|||Day 8||0.63|-0.35|= 0.572
91575209|NCT03838731|183038729|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|=|0.997|TWO_SIDED|95.0|-0.41|0.41|||MMRM|||Day 29||0.41|-0.41|= 0.997
91575210|NCT03838731|183038729|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.21|=|0.756|TWO_SIDED|95.0|-0.36|0.49|||MMRM|||Day 57||0.49|-0.36|= 0.756
91575211|NCT03838731|183038729|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15|=|0.333|TWO_SIDED|95.0|-0.46|0.16|||MMRM|||Day 85||0.16|-0.46|= 0.333
91575212|NCT03838731|183038730|SUPERIORITY||LS Mean Difference|39.5|STANDARD_ERROR_OF_MEAN|12.5|=|0.003|TWO_SIDED|95.0|14.36|64.65|||MMRM|||Day 8||64.65|14.36|= 0.003
91575213|NCT03838731|183038730|SUPERIORITY||LS Mean Difference|54.07|STANDARD_ERROR_OF_MEAN|11.97|<|0.001|TWO_SIDED|95.0|30.01|78.12|||MMRM|||Day 29||78.12|30.01|< 0.001
91575214|NCT03838731|183038730|SUPERIORITY||LS Mean Difference|33.44|STANDARD_ERROR_OF_MEAN|14.28|=|0.023|TWO_SIDED|95.0|4.79|62.08|||MMRM|||Day 57||62.08|4.79|= 0.023
91575215|NCT03838731|183038730|SUPERIORITY||LS Mean Difference|41.1|STANDARD_ERROR_OF_MEAN|12.92|=|0.003|TWO_SIDED|95.0|15.1|67.09|||MMRM|||Day 85||67.09|15.10|= 0.003
91575216|NCT03838731|183038731|SUPERIORITY||LS Mean Difference|205.43|STANDARD_ERROR_OF_MEAN|102.09|=|0.049|TWO_SIDED|95.0|0.69|410.17|||MMRM|||Day 8||410.17|0.69|= 0.049
91575217|NCT03838731|183038731|SUPERIORITY||LS Mean Difference|244.6|STANDARD_ERROR_OF_MEAN|99.05|=|0.017|TWO_SIDED|95.0|45.6|443.59|||MMRM|||Day 29||443.59|45.60|= 0.017
91575218|NCT03838731|183038731|SUPERIORITY||LS Mean Difference|183.03|STANDARD_ERROR_OF_MEAN|96.91|=|0.064|TWO_SIDED|95.0|-11.29|377.35|||MMRM|||Day 57||377.35|-11.29|= 0.064
91575219|NCT03838731|183038731|SUPERIORITY||LS Mean Difference|241.01|STANDARD_ERROR_OF_MEAN|114.0|=|0.039|TWO_SIDED|95.0|12.44|469.57|||MMRM|||Day 85||469.57|12.44|= 0.039
91575220|NCT00789360|183038771|OTHER||Maximum LS mean change difference|0.0917|||||TWO_SIDED|90.0|-0.028|0.212|||||Maximum difference occurred at 10 hours|The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry||0.212|-0.028|
91575221|NCT00789360|183038772|OTHER||Maximum LS mean change difference|-0.154|||||TWO_SIDED|90.0|-0.29|-0.019|||||Greatest difference occurred at 9 hours after Dose 1|||-0.019|-0.290|
91575222|NCT03559062|183038773|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
91575223|NCT03559062|183038774|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
91575224|NCT03559062|183038775|OTHER|||||||0.0546|||||||Mixed-effects model for repeated measure|||||||0.0546
91575225|NCT01757197|183038777|OTHER|Not evaluable.|Other|0.0|||||TWO_SIDED|||||Not evaluable.||||Not evaluable.|Not evaluable.|||
91575226|NCT01677299|183038795|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-22.5|||<|0.05|TWO_SIDED|95.0|-37.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment A.||||-8|-37|<0.05
91575227|NCT01677299|183038795|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-20.0|||<|0.05|TWO_SIDED|95.0|-30.0|-9.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment B.||||-9|-30|<0.05
91575228|NCT01677299|183038795|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-16.0|||<|0.05|TWO_SIDED|95.0|-24.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment C.||||-8|-24|<0.05
91575229|NCT01677299|183038795|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-21.0|||<|0.05|TWO_SIDED|95.0|-31.0|-11.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment D.||||-11|-31|<0.05
91575230|NCT01677299|183038796|SUPERIORITY_OR_OTHER||Geometric LS mean ration|1.6|||<|0.05|TWO_SIDED|95.0|1.4|1.9|||Mixed Models Analysis|||||1.9|1.4|<0.05
91575231|NCT01677299|183038796|SUPERIORITY_OR_OTHER||Geo LSmean ratio of (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
91575232|NCT01677299|183038796|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.7|||<|0.05|TWO_SIDED|95.0|1.4|2.0|||Mixed Models Analysis|||||2.0|1.4|<0.05
91575233|NCT01677299|183038796|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
91575234|NCT01677299|183038797|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.8|||Mixed Models Analysis|||||1.8|1.4|<0.05
91575235|NCT01677299|183038797|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.4|||<|0.05|TWO_SIDED|95.0|1.2|1.6|||Mixed Models Analysis|||||1.6|1.2|<0.05
91575236|NCT01677299|183038797|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.3|1.6|||Mixed Models Analysis|||||1.6|1.3|<0.05
91575237|NCT01677299|183038797|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.6|||Mixed Models Analysis|||||1.6|1.4|<0.05
91575238|NCT00955708|183038816|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|95.3|||||ONE_SIDED|95.0|94.0||||||The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.|The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.|||94.0|
91575239|NCT00955708|183038816|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|100.0|||||ONE_SIDED|95.0|100.0|||||||The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.|||100|
91575240|NCT01735175|183038841|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|The difference between LA-EP2006 and reference pegfilgrastim was 0.07 days (95% CI \[-0.12, 0.26\]). 95% CIs were within the predefined margin of ±1 day confirming equivalence.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
91575241|NCT01735175|183038841|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
91575242|NCT00755417|183038849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.38||0.0117|TWO_SIDED|97.5|-1.81|-0.11||Based on F test of type III analysis for pairwise comparison at 0.025 level.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4||-0.11|-1.81|0.0117
91575243|NCT00755417|183038849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|97.5|-2.35|-0.66||Based on F test of type III analysis|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4.||-0.66|-2.35|<0.0001
91575244|NCT00755417|183038850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.42||0.183|TWO_SIDED|97.5|-1.49|0.38||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12||0.38|-1.49|0.1830
91575245|NCT00755417|183038850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.41||0.1975|TWO_SIDED|97.5|-1.46|0.4||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12.||0.40|-1.46|0.1975
91575246|NCT00755417|183038851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.0016|TWO_SIDED|97.5|-0.44|-0.08||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.08|-0.44|0.0016
91575247|NCT00755417|183038851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.51|-0.14||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.14|-0.51|<0.0001
91575248|NCT00755417|183038852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0433|TWO_SIDED|97.5|-0.43|0.02||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.02|-0.43|0.0433
91575249|NCT00755417|183038852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0468|TWO_SIDED|97.5|-0.42|0.03||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.03|-0.42|0.0468
91575250|NCT03443414|183038853|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.139|||<|0.001|TWO_SIDED|95.0|0.069|0.21|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.210|0.069|<0.001
91575251|NCT03443414|183038853|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.2|||<|0.001|TWO_SIDED|95.0|0.131|0.27|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.270|0.131|<0.001
91575252|NCT03443414|183038853|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.083|0.222|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.222|0.083|<0.001
91575253|NCT03443414|183038853|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.146|||<|0.001|TWO_SIDED|95.0|0.075|0.216|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.216|0.075|<0.001
91575254|NCT03443414|183038854|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.002|||=|0.953|TWO_SIDED|95.0|-0.061|0.065|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.065|-0.061|=0.953
91575255|NCT03443414|183038854|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.068|||=|0.032|TWO_SIDED|95.0|0.006|0.13|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.130|0.006|=0.032
91575256|NCT03443414|183038854|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.009|||=|0.773|TWO_SIDED|95.0|-0.053|0.072|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.072|-0.053|=0.773
91575257|NCT03443414|183038854|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.035|||=|0.272|TWO_SIDED|95.0|-0.028|0.099|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.099|-0.028|=0.272
91575258|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.087|||<|0.001|TWO_SIDED|95.0|0.045|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Day 1.||0.129|0.045|<0.001
91575259|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.053|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Day 1.||0.137|0.053|<0.001
91575260|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.07|||=|0.001|TWO_SIDED|95.0|0.028|0.112|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Day 1.||0.112|0.028|=0.001
91575261|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.038|0.122|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Day 1.||0.122|0.038|<0.001
91575262|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.065|||=|0.048|TWO_SIDED|95.0|0.001|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Week 4.||0.129|0.001|=0.048
91575263|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.119|||<|0.001|TWO_SIDED|95.0|0.055|0.183|||LS mean difference|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Week 4.||0.183|0.055|<0.001
91575264|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.085|||=|0.008|TWO_SIDED|95.0|0.022|0.149|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Week 4.||0.149|0.022|=0.008
91575265|NCT03443414|183038855|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.072|||=|0.028|TWO_SIDED|95.0|0.008|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Week 4.||0.137|0.008|=0.028
91575266|NCT02103114|183038861|EQUIVALENCE|T1 (Baseline)||||||0.982|||||||t-test, 2 sided|||||||0.982
91575267|NCT02103114|183038861|EQUIVALENCE|T2 (30 minutes after study drug)|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91575268|NCT02103114|183038861|EQUIVALENCE|T3 (30 minutes on CPB)||||||0.001|||||||t-test, 2 sided|||||||0.001
91575269|NCT02103114|183038861|EQUIVALENCE|T5 (Arrival in ICU)||||||0.003|||||||t-test, 2 sided|||||||0.003
91575270|NCT02103114|183038861|EQUIVALENCE|T6 (POD 2)||||||0.84|||||||t-test, 2 sided|||||||0.840
91575271|NCT02103114|183038861|EQUIVALENCE|T7 (POD 4)||||||0.475|||||||t-test, 2 sided|||||||0.475
91575272|NCT02103114|183038862|EQUIVALENCE|T4 (just prior to coming off of CPB)||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
91575273|NCT02103114|183038863|EQUIVALENCE|T1 (Baseline)||||||0.855|||||||Wilcoxon (Mann-Whitney)|||||||0.855
91575274|NCT02103114|183038863|EQUIVALENCE|T5 (Arrival in ICU)||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
91575275|NCT02103114|183038863|EQUIVALENCE|T6 (POD 2)||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
91575276|NCT02103114|183038863|EQUIVALENCE|T7 (POD 4)||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
91575277|NCT02103114|183038866|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.056|||||||Wilcoxon (Mann-Whitney)|||||||0.056
91575278|NCT02103114|183038867|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.545|||||||Wilcoxon (Mann-Whitney)|||||||0.545
91575279|NCT02103114|183038869|EQUIVALENCE|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||||0.757|||||||Wilcoxon (Mann-Whitney)|||||||0.757
91575280|NCT02103114|183038872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2741|||||||t-test, 2 sided|24 hour postop Fresh Frozen Plasma exposures||||||0.2741
91575281|NCT02103114|183038872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0351|||||||t-test, 2 sided|24 hour postop Platelet exposures||||||0.0351
91575282|NCT02103114|183038872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||t-test, 2 sided|24 hour postop Cryoprecipitate exposures||||||0.073
91575283|NCT02103114|183038872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||t-test, 2 sided|24 hour postop Red Blood Cell exposures||||||0.0196
91575284|NCT02103114|183038873|EQUIVALENCE|protamine time plus 24 hours||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
91575285|NCT02103114|183038875|EQUIVALENCE|24 Hours Post-Operatively||||||0.0004|||||||Fisher Exact|||||||0.0004
91575286|NCT02103114|183038876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927|||||||t-test, 2 sided|||||||0.927
91575287|NCT02103114|183038877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738|||||||t-test, 2 sided|||||||0.738
91575288|NCT02103114|183038878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||Fisher Exact|||||||0.231
91575289|NCT02103114|183038879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.661|||||||Fisher Exact|||||||0.661
91575290|NCT02103114|183038881|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||||||1.0
91575291|NCT02103114|183038882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342|||||||Fisher Exact|||||||0.342
91575292|NCT02103114|183038883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||t-test, 2 sided|||||||0.961
91575293|NCT03933462|183038884|SUPERIORITY|"Categorical preference endpoints that answered at the final visit (e.g., Which device do you prefer?) were analyzed with a One-sample Binomial Test that compared the observed proportion to a 50/50 split."|||||<|0.001|||||||One Sample Binomial|||||||<0.001
91575294|NCT01266161|183038907|SUPERIORITY||Mean Difference (Final Values)|23.76|||<|0.001|TWO_SIDED|95.0|16.45|31.07||p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||31.07|16.45|<0.001
91575295|NCT01266161|183038908|SUPERIORITY||Mean Difference (Final Values)|8.42|||<|0.001|TWO_SIDED|95.0|4.13|12.71||p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||12.71|4.13|<0.001
91575296|NCT01266161|183038909|SUPERIORITY||Least-squares means|8.95|||<|0.001|TWO_SIDED|95.0|5.94|11.95||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-12.||11.95|5.94|<0.001
91575297|NCT01266161|183038909|SUPERIORITY||Least-squares means|3.15|||<|0.001|TWO_SIDED|95.0|1.45|4.85||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 8-12.||4.85|1.45|<0.001
91575298|NCT01266161|183038909|SUPERIORITY||Least-squares means|6.56|||<|0.001|TWO_SIDED|95.0|2.84|10.27||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 12-24.||10.27|2.84|<0.001
91575299|NCT01266161|183038909|SUPERIORITY||Least-squares means|2.02||||0.091|TWO_SIDED|95.0|-0.33|4.37||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 20-24.||4.37|-0.33|0.091
91575300|NCT01266161|183038909|SUPERIORITY||Least-squares means|14.95|||<|0.001|TWO_SIDED|95.0|9.12|20.79||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-24.||20.79|9.12|<0.001
91575301|NCT01266161|183038909|SUPERIORITY||Least-squares means|5.87||||0.01|TWO_SIDED|95.0|1.42|10.33||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-36.||10.33|1.42|0.010
91575302|NCT01266161|183038909|SUPERIORITY||Least-squares means|3.48||||0.004|TWO_SIDED|95.0|1.13|5.83||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 32-36.||5.83|1.13|0.004
91575303|NCT01266161|183038909|SUPERIORITY||Least-squares means|6.09||||0.006|TWO_SIDED|95.0|1.82|10.36||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 36-48.||10.36|1.82|0.006
91575304|NCT01266161|183038909|SUPERIORITY||Least-squares means|2.41||||0.042|TWO_SIDED|95.0|0.09|4.73||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 44-48.||4.73|0.09|0.042
91575305|NCT01266161|183038909|SUPERIORITY||Least-squares means|10.97||||0.004|TWO_SIDED|95.0|3.49|18.45||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-48.||18.45|3.49|0.004
91575306|NCT01266161|183038910|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001||95.0|0.1|0.34|||proportional hazards model|||||0.34|0.10|<0.001
91575307|NCT01266161|183038911|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.46|-31.56||p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the first dosing interval (0 to 12 hours).||-31.56|-64.46|<0.001
91575308|NCT01266161|183038911|SUPERIORITY||Treatment Difference|-25.53|||<|0.001||95.0|-39.78|-11.28||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the second dosing interval (12 to 24 hours).||-11.28|-39.78|<0.001
91575309|NCT01266161|183038911|SUPERIORITY||Treatment Difference|-24.05||||0.002||95.0|-38.93|-9.18||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the third dosing interval (24 to 36 hours).||-9.18|-38.93|0.002
91575310|NCT01266161|183038911|SUPERIORITY||Treatment Difference|-13.6||||0.035||95.0|-26.41|-0.79||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the fourth dosing interval (36 to 48 hours).||-0.79|-26.41|0.035
91575311|NCT01266161|183038911|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.42|-31.6||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the study overall (0 to 48 hours).||-31.60|-64.42|<0.001
91575312|NCT01266161|183038911|SUPERIORITY||Cox proportional hazard models|0.086||||0.011|TWO_SIDED|95.0|0.01|0.57|||Andersen-Gill (AG)|||Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)||0.57|0.01|0.011
91575313|NCT01266161|183038912|SUPERIORITY||Least squares means|0.84|||<|0.001||95.0|0.5|1.19||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.19|0.50|<0.001
91575314|NCT01266161|183038912|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|1.11|1.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.94|1.11|<0.001
91575315|NCT01266161|183038912|SUPERIORITY||Least squares means|2.0|||<|0.001||95.0|1.56|2.44||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||2.44|1.56|<0.001
91575316|NCT01266161|183038912|SUPERIORITY||Least squares means|2.29|||<|0.001||95.0|1.86|2.73||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||2.73|1.86|<0.001
91575317|NCT01266161|183038912|SUPERIORITY||Least squares means|2.18|||<|0.001||95.0|1.69|2.68||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||2.68|1.69|<0.001
91575318|NCT01266161|183038912|SUPERIORITY||Least squares means|0.92|||<|0.001||95.0|0.46|1.38||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.|Ibuprofen versus placebo at 6 hours.||1.38|0.46|<0.001
91575319|NCT01266161|183038912|SUPERIORITY||Least squares means|1.04|||<|0.001||95.0|0.54|1.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||1.54|0.54|<0.001
91575320|NCT01266161|183038912|SUPERIORITY||Least squares means|1.1|||<|0.001||95.0|0.59|1.6||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||1.60|0.59|<0.001
91575321|NCT01266161|183038912|SUPERIORITY||Least squares means|0.5||||0.052||95.0|0.0|1.01||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.01|-0.00|0.052
91575322|NCT01266161|183038913|SUPERIORITY||Least squares means|0.37|||<|0.001||95.0|0.16|0.59||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||0.59|0.16|<0.001
91575323|NCT01266161|183038913|SUPERIORITY||Least squares means|0.9|||<|0.001||95.0|0.63|1.18||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.18|0.63|<0.001
91575324|NCT01266161|183038913|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.91|1.52||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||1.52|0.91|<0.001
91575325|NCT01266161|183038913|SUPERIORITY||Least squares means|1.4|||<|0.001||95.0|1.1|1.71||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||1.71|1.10|<0.001
91575326|NCT01266161|183038913|SUPERIORITY||Least squares means|1.32|||<|0.001||95.0|0.97|1.67||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||1.67|0.97|<0.001
91575327|NCT01266161|183038913|SUPERIORITY||Least squares means|0.61|||<|0.001||95.0|0.3|0.91||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||0.91|0.30|<0.001
91575328|NCT01266161|183038913|SUPERIORITY||Least squares means|0.64|||<|0.001||95.0|0.31|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||0.97|0.31|<0.001
91575329|NCT01266161|183038913|SUPERIORITY||Least squares means|0.66|||<|0.001||95.0|0.36|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||0.97|0.36|<0.001
91575330|NCT01266161|183038913|SUPERIORITY||Least squares means|0.27||||0.089||95.0|-0.04|0.59||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||0.59|-0.04|0.089
91575331|NCT01266161|183038913|SUPERIORITY||Least squares means|1.0|||<|0.001||95.0|0.7|1.29||Ibuprofen versus placebo at 0.5 hours.|ANOVA|||Ibuprofen versus placebo at 16 hours.||1.29|0.70|<0.001
91575332|NCT01266161|183038913|SUPERIORITY||Least squares means|0.47||||0.004||95.0|0.15|0.78||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 20 hours.||0.78|0.15|0.004
91575333|NCT01266161|183038913|SUPERIORITY||Least squares means|0.04||||0.821||95.0|-0.28|0.35||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 24 hours.||0.35|-0.28|0.821
91575334|NCT01266161|183038913|SUPERIORITY||Least squares means|0.56||||0.001||95.0|0.23|0.9||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 28 hours.||0.90|0.23|0.001
91575335|NCT01266161|183038913|SUPERIORITY||Least squares means|0.62|||<|0.001||95.0|0.3|0.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 32 hours.||0.94|0.30|<0.001
91575336|NCT01266161|183038913|SUPERIORITY||Least squares means|0.25||||0.127||95.0|-0.07|0.57||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 36 hours.||0.57|-0.07|0.127
91575337|NCT01266161|183038913|SUPERIORITY||Least squares means|0.67|||<|0.001||95.0|0.35|1.0||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 40 hours.||1.00|0.35|<0.001
91575338|NCT01266161|183038913|SUPERIORITY||Least squares means|0.34||||0.036||95.0|0.02|0.67||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 44 hours.||0.67|0.02|0.036
91575339|NCT01266161|183038913|SUPERIORITY||Least squares means|0.26||||0.091||95.0|-0.04|0.56||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 48 hours.||0.56|-0.04|0.091
91575340|NCT01266161|183038914|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.69|1.74||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.74|0.69|<0.001
91575341|NCT01266161|183038914|SUPERIORITY||Least squares means|2.43|||<|0.001||95.0|1.77|3.09||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||3.09|1.77|<0.001
91575342|NCT01266161|183038914|SUPERIORITY||Least squares means|3.22|||<|0.001||95.0|2.49|3.95||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||3.95|2.49|<0.001
91575343|NCT01266161|183038914|SUPERIORITY||Least squares means|3.7|||<|0.001||95.0|2.98|4.42||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||4.42|2.98|<0.001
91575344|NCT01266161|183038914|SUPERIORITY||Least squares means|3.5|||<|0.001||95.0|2.67|4.33||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||4.33|2.67|<0.001
91575345|NCT01266161|183038914|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|0.79|2.27||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||2.27|0.79|<0.001
91575346|NCT01266161|183038914|SUPERIORITY||Least squares means|1.67|||<|0.001||95.0|0.87|2.48||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||2.48|0.87|<0.001
91575347|NCT01266161|183038914|SUPERIORITY||Least squares means|1.76|||<|0.001||95.0|0.97|2.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||2.54|0.97|<0.001
91575348|NCT01266161|183038914|SUPERIORITY||Least squares means|0.78||||0.056||95.0|-0.02|1.58||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.58|-0.02|0.056
91575349|NCT01266161|183038915|SUPERIORITY||Least squares means|14.82|||<|0.001|TWO_SIDED|95.0|10.38|19.25||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0 to 12 hours.||19.25|10.38|<0.001
91575350|NCT01266161|183038915|SUPERIORITY||Least squares means|5.27|||<|0.001|TWO_SIDED|95.0|2.57|7.98||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo from 8 to 12 hours.||7.98|2.57|<0.001
91575351|NCT01266161|183038916|SUPERIORITY||CMH-adjusted proportion|-0.73|||<|0.001|TWO_SIDED|95.0|-0.91|-0.55||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the first dosing interval.||-0.55|-0.91|<0.001
91575352|NCT01266161|183038916|SUPERIORITY||CMH-adjusted proportions|-0.72|||<|0.001|TWO_SIDED|95.0|-1.05|-0.4||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.|Cochran-Mantel-Haenszel|||For the second dosing interval.||-0.40|-1.05|<0.001
91575353|NCT01266161|183038916|SUPERIORITY||CMH-adjusted proportions|-0.48||||0.002|TWO_SIDED|95.0|-0.9|-0.06||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the third dosing interval.||-0.06|-0.90|0.002
91575354|NCT01266161|183038916|SUPERIORITY||CMH-adjusted proportion|-0.68||||0.021|TWO_SIDED|95.0|-1.02|-0.35||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the fourth dosing interval.||-0.35|-1.02|0.021
91575355|NCT01266161|183038916|SUPERIORITY||CMH-adjusted proportion|-0.7|||<|0.001|TWO_SIDED|95.0|-0.89|-0.51||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the overall study duration.||-0.51|-0.89|<0.001
91575356|NCT01266161|183038919|SUPERIORITY||Gamma statistic|0.85|||<|0.001|TWO_SIDED|95.0|0.74|0.95||p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.|Cochran-Mantel-Haenszel|||Ibuprofen versus placebo at 24 hours||0.95|0.74|<0.001
91575357|NCT01266161|183038919|SUPERIORITY||Gamma statistic|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.92|||Cochran-Mantel-Haenszel|p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.||Ibuprofen versus placebo at 48 hours||0.92|0.66|<0.001
91575358|NCT04692467|183038920|SUPERIORITY||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.77|-3.01|||Mixed Models Analysis||The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).|||-3.01|-8.77|<0.0001
91575359|NCT03355209|183038933|SUPERIORITY||Median Difference (A-P)|-19.88||||0.0008|TWO_SIDED|95.0|-31.02|-8.74|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||-8.74|-31.02|0.0008
91575360|NCT03355209|183038936|SUPERIORITY||Median Difference (A-P)|-10.5||||0.146|TWO_SIDED|95.0|-24.99|3.99|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||3.99|-24.99|0.1460
91575361|NCT03355209|183038937|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0051|TWO_SIDED|95.0|1.43|7.59|||Regression, Logistic|||||7.59|1.43|0.0051
91575362|NCT03355209|183038937|SUPERIORITY||Odds Ratio (OR)|2.87||||0.015|TWO_SIDED|95.0|1.23|6.7|||Regression, Logistic|||||6.70|1.23|0.0150
91575363|NCT03355209|183038938|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1565|TWO_SIDED|95.0|0.84|2.97|||Cochran-Mantel-Haenszel|||Visit 12||2.97|0.84|0.1565
91575364|NCT03355209|183038938|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0567|TWO_SIDED|95.0|0.98|3.52|||Cochran-Mantel-Haenszel|||Visit 12||3.52|0.98|0.0567
91575365|NCT01621776|183038978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.1|STANDARD_DEVIATION|78.04||0.971||95.0|129.73|160.47|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||160.47|129.73|.971
91575366|NCT01621776|183038979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|161.09|STANDARD_DEVIATION|62.67||0.698|TWO_SIDED|95.0|144.91|177.28|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||177.28|144.91|.698
91575367|NCT01621776|183038980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|220.46|STANDARD_DEVIATION|89.97||0.806|TWO_SIDED|95.0|197.22|243.71|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||243.71|197.22|.806
91575368|NCT04916730|183038997|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91575369|NCT02078492|183039019|NON_INFERIORITY_OR_EQUIVALENCE|We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.||||||0.783|||||||ANOVA|2 degrees of freedom||The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.||||.783
91575370|NCT05672771|183039020|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.355|TWO_SIDED||||||ANOVA|||||||0.355
91575371|NCT05672771|183039021|SUPERIORITY||Mean Difference (Final Values)|0.56|||<|0.02|TWO_SIDED||||||ANOVA||This is the difference between the Different Mixed and Placebo Control conditions.|||||<.02
91575372|NCT05672771|183039022|OTHER||||||<|0.05||||||for contrasts of DM, DS, and ST groups relative to the PC group.|Mixed Models Analysis|||||||<.05
91575373|NCT00760747|183039025|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|-0.7|STANDARD_ERROR_OF_MEAN|1.7||0.692|TWO_SIDED|95.0|-4.0|2.6|||Mixed Models Analysis|||||2.6|-4.0|0.692
91575374|NCT00760747|183039026|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.456|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.456
91575375|NCT00760747|183039027|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.517|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.517
91575376|NCT00760747|183039028|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.526|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.526
91575377|NCT00760747|183039029|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.898|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||||0.4|-0.4|0.898
91575378|NCT00760747|183039034|SUPERIORITY_OR_OTHER||Least square mean differences at week 2|-0.1|STANDARD_ERROR_OF_MEAN|1.4||0.927|TWO_SIDED|95.0|-2.9|2.6|||Mixed Models Analysis|||||2.6|-2.9|0.927
91575379|NCT00402051|183039068|SUPERIORITY_OR_OTHER||6-Month PFS Rate|52.8|||||TWO_SIDED|95.0|40.3|65.3||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||65.3|40.3|
91575380|NCT00402051|183039068|SUPERIORITY_OR_OTHER||6-Month PFS Rate|39.3|||||TWO_SIDED|95.0|27.8|50.8||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||50.8|27.8|
91575381|NCT00402051|183039070|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|32.3||||||95.0|21.2|45.1||||||Response rates were evaluated separately for each treatment arm||45.1|21.2|
91575382|NCT00402051|183039070|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|20.0||||||95.0|11.1|31.8||||||Response rates were evaluated separately for each treatment arm||31.8|11.1|
91575383|NCT05472740|183039109|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
91575384|NCT05131477|183039136|SUPERIORITY||LS Mean Difference|-32.1|STANDARD_ERROR_OF_MEAN|6.01|<|0.0001|TWO_SIDED|95.0|-43.9|-20.3|||ANCOVA||LS Mean Difference|||-20.3|-43.9|<0.0001
91575385|NCT05131477|183039136|SUPERIORITY||LS Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|5.98|<|0.0001|TWO_SIDED|95.0|-39.1|-15.6|||ANCOVA||LS Mean Difference|||-15.6|-39.1|<0.0001
91575386|NCT05131477|183039136|SUPERIORITY||LS Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.01||0.0002|TWO_SIDED|95.0|-34.0|-10.4|||ANCOVA||LS Mean Difference|||-10.4|-34.0|0.0002
91575387|NCT05131477|183039136|SUPERIORITY||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|5.95|<|0.0001|TWO_SIDED|95.0|-41.9|-18.5|||ANCOVA|||||-18.5|-41.9|<0.0001
91575388|NCT05131477|183039137|SUPERIORITY||LS Mean Difference|-36.8|STANDARD_ERROR_OF_MEAN|6.62|<|0.0001|TWO_SIDED|95.0|-49.8|-23.8|||ANCOVA||LS Mean Difference|||-23.8|-49.8|<0.0001
91575389|NCT05131477|183039137|SUPERIORITY||LS Mean Difference|-24.6|STANDARD_ERROR_OF_MEAN|6.67||0.0002|TWO_SIDED|95.0|-37.7|-11.6|||ANCOVA||LS Mean Difference|||-11.6|-37.7|0.0002
91575390|NCT05131477|183039137|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.2|-13.1|||ANCOVA||LS Mean Difference|||-13.1|-39.2|<0.0001
91575391|NCT05131477|183039137|SUPERIORITY||LS Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|-39.7|-13.9|||ANCOVA||LS Mean Difference|||-13.9|-39.7|<0.0001
91575392|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|< 0.0001
91575393|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.4|||Cochran-Mantel-Haenszel|||Week 16||0.40|0.14|< 0.0001
91575394|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.44|||Cochran-Mantel-Haenszel|||Week 16||0.44|0.18|<0.0001
91575395|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|<0.0001
91575396|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.5|||Cochran-Mantel-Haenszel|||Week 24||0.5|0.23|<0.0001
91575397|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.21||||0.004|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.07|0.0040
91575398|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.17|0.45|||Cochran-Mantel-Haenszel|||||0.45|0.17|<0.0001
91575399|NCT05131477|183039138|SUPERIORITY||Proportion Difference|0.23||||0.0016|TWO_SIDED|95.0|0.09|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.09|0.0016
91575400|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.17||||0.0022|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||Week 16||0.27|0.06|0.0022
91575401|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.09||||0.0562|TWO_SIDED|95.0|0.0|0.18|||Cochran-Mantel-Haenszel|||Week 16||0.18|0|0.0562
91575402|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.14||||0.0054|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0054
91575403|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.2||||0.0003|TWO_SIDED|95.0|0.1|0.31|||Cochran-Mantel-Haenszel|||Week 16||0.31|0.1|0.0003
91575404|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||Cochran-Mantel-Haenszel|||Week 24||0.47|0.21|<0.0001
91575405|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.22||||0.0008|TWO_SIDED|95.0|0.1|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.1|0.0008
91575406|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.41|||Cochran-Mantel-Haenszel|||Week 24||0.41|0.16|<0.0001
91575407|NCT05131477|183039139|SUPERIORITY||Proportion Difference|0.18||||0.0046|TWO_SIDED|95.0|0.06|0.3|||Cochran-Mantel-Haenszel|||Week 24||0.3|0.06|0.0046
91575408|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.19||||0.0006|TWO_SIDED|95.0|0.09|0.3|||Cochran-Mantel-Haenszel|||Week 16||0.3|0.09|0.0006
91575409|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.14||||0.0057|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0057
91575410|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.16||||0.0038|TWO_SIDED|95.0|0.05|0.26|||Cochran-Mantel-Haenszel|||Week 16||0.26|0.05|0.0038
91575411|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.18||||0.0011|TWO_SIDED|95.0|0.07|0.28|||Cochran-Mantel-Haenszel|||Week 16||0.28|0.07|0.0011
91575412|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.23||||0.0002|TWO_SIDED|95.0|0.11|0.35|||Cochran-Mantel-Haenszel|||Week 24||0.35|0.11|0.0002
91575413|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.17||||0.0038|TWO_SIDED|95.0|0.06|0.28|||Cochran-Mantel-Haenszel|||Week 24||0.28|0.06|0.0038
91575414|NCT05131477|183039140|SUPERIORITY||Proportion Difference|0.21||||0.0006|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||Week 24||0.32|0.09|0.0006
91575415|NCT05131477|183039140|SUPERIORITY||Proportion Difference|20.0||||0.0008|TWO_SIDED|95.0|9.0|32.0|||Cochran-Mantel-Haenszel|||Week 24||32|9|0.0008
91575416|NCT02726945|183039229|SUPERIORITY|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.023
91575417|NCT02726945|183039229|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.043
91575418|NCT01681277|183039241|SUPERIORITY_OR_OTHER||Slope|1.2208|STANDARD_ERROR_OF_MEAN|0.1386|||TWO_SIDED|95.0|0.9354|1.5062|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.||1.5062|0.9354|
91575419|NCT01681277|183039243|SUPERIORITY_OR_OTHER||Slope|1.3135|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|1.0652|1.5618|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.||1.5618|1.0652|
91575420|NCT01128270|183039296|SUPERIORITY_OR_OTHER||Mean of one group (2A)|1.64|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|1.31|1.97||||Analysis applies only to Arm 2A. (Period 3)|Only arm 2A is relevant to this variable. There is no intended statistical comparison, but the point estimate for the mean level and 95% confidence interval are provided.|No comparison is relevant. The statistical method is how we obtained the point estimate and confidence interval. No test was intended.||1.97|1.31|
91575421|NCT01128270|183039297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2432.0|STANDARD_DEVIATION|1403.0||0.0017|TWO_SIDED|95.0|1260.0|3606.0|||t-test, 2 sided|||Only relevant to Arm 2B.||3606|1260|0.0017
91575422|NCT01128270|183039298|SUPERIORITY_OR_OTHER||Mean|0.38|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|0.24|0.51||||||Only relevant for arm 2B||0.51|0.24|
91575423|NCT01825577|183039347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||.55
91575424|NCT01825577|183039348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||.67
91575425|NCT03518567|183039423|SUPERIORITY||Slope|0.78||||4e-08|TWO_SIDED||||||Regression, Linear|"hits purchased on the MPT predicting hits actually purchased and smoked in the laboratory.~covariate: baseline total individual income"||||||.00000004
91575426|NCT03518567|183039424|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_DEVIATION|1.09||9e-09|TWO_SIDED||||||t-test, 2 sided|||||||.000000009
91514170|NCT04079933|182900462|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-11.9||||0.2905|TWO_SIDED|95.0|-33.9|10.2|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||10.2|-33.9|0.2905
91575427|NCT03518567|183039425|SUPERIORITY||correlation|0.02||||0.87|TWO_SIDED||||||correlation|Correlation between puffs on the topography device and grams of cannabis used per week.||||||.87
91575428|NCT03321253|183039428|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
91575429|NCT01791972|183039455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|STANDARD_ERROR_OF_MEAN|1.982|<|0.0001|TWO_SIDED|95.0|-20.19|-12.14||Significance level is 0.05.|mixed-effect analysis of covariance|Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.||||-12.14|-20.19|<0.0001
91575430|NCT01791972|183039456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|0.53|0.84||Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.|Regression, Logistic|||||0.84|0.53|<0.0001
91575431|NCT02209181|183039480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.38|STANDARD_ERROR_OF_MEAN|2.522|<|0.001|TWO_SIDED|95.0|11.42|21.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.35|11.42|<0.001
91575432|NCT02209181|183039480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|2.503||0.068|TWO_SIDED|95.0|-0.35|9.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||9.51|-0.35|0.068
91575433|NCT02209181|183039480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.2|STANDARD_ERROR_OF_MEAN|2.531|<|0.001|TWO_SIDED|95.0|11.21|21.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.18|11.21|<0.001
91575434|NCT02209181|183039480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.81|STANDARD_ERROR_OF_MEAN|2.503|<|0.001|TWO_SIDED|95.0|-16.73|-6.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-6.88|-16.73|<0.001
91575435|NCT02209181|183039480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.531||0.941|TWO_SIDED|95.0|-5.17|4.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.80|-5.17|0.941
91575436|NCT02209181|183039481|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.448|TWO_SIDED|95.0|-0.19|0.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.19|0.448
91575437|NCT02209181|183039481|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.15||0.618|TWO_SIDED|95.0|-0.38|0.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.38|0.618
91575438|NCT02209181|183039481|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.621|TWO_SIDED|95.0|-0.23|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.23|0.621
91575439|NCT02209181|183039481|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.207|TWO_SIDED|95.0|-0.49|0.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.11|-0.49|0.207
91575440|NCT02209181|183039481|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.794|TWO_SIDED|95.0|-0.34|0.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.26|-0.34|0.794
91575441|NCT02209181|183039482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.82|1.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.86|0.82|<0.001
91575442|NCT02209181|183039482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.26||0.42|TWO_SIDED|95.0|-0.3|0.72||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.72|-0.30|0.420
91575443|NCT02209181|183039482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.083|TWO_SIDED|95.0|-0.06|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.06|0.083
91575444|NCT02209181|183039482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.64|-0.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.62|-1.64|<0.001
91575445|NCT02209181|183039482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.4|-0.37||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.37|-1.40|<0.001
91575446|NCT02209181|183039483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.93|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|2.28|3.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.59|2.28|<0.001
91575447|NCT02209181|183039483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.33||0.058|TWO_SIDED|95.0|-0.02|1.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.29|-0.02|0.058
91575448|NCT02209181|183039483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.23|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.57|1.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.89|0.57|<0.001
91575449|NCT02209181|183039483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-2.96|-1.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.65|-2.96|<0.001
91575450|NCT02209181|183039483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.37|-1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.04|-2.37|<0.001
91575451|NCT02209181|183039484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|3.01|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|3.01|<0.001
91575452|NCT02209181|183039484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.36||0.035|TWO_SIDED|95.0|0.06|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|0.06|0.035
91575453|NCT02209181|183039484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.21|2.67||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.67|1.21|<0.001
91575454|NCT02209181|183039484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.68|-2.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.24|-3.68|<0.001
91575455|NCT02209181|183039484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.52|-1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.07|-2.52|<0.001
91575456|NCT02209181|183039485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|3.21|4.77||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.77|3.21|<0.001
91575457|NCT02209181|183039485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.39||0.028|TWO_SIDED|95.0|0.09|1.64||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.64|0.09|0.028
91575458|NCT02209181|183039485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.7|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|1.70|<0.001
91575459|NCT02209181|183039485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.9|-2.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.35|-3.90|<0.001
91575460|NCT02209181|183039485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.29|-0.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.73|-2.29|<0.001
91575461|NCT02209181|183039486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.92|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.92|<0.001
91575462|NCT02209181|183039486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|0.16|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|0.16|0.021
91575463|NCT02209181|183039486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.19|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|2.19|<0.001
91575464|NCT02209181|183039486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.63|-1.91||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.91|-3.63|<0.001
91575465|NCT02209181|183039486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.44||0.104|TWO_SIDED|95.0|-1.59|0.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.15|-1.59|0.104
91575466|NCT02209181|183039487|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.18|4.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.07|2.18|<0.001
91575467|NCT02209181|183039487|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.98|STANDARD_ERROR_OF_MEAN|0.48||0.041|TWO_SIDED|95.0|0.04|1.92||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.92|0.04|0.041
91575468|NCT02209181|183039487|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.19|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|2.19|<0.001
91575469|NCT02209181|183039487|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.09|-1.21||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.21|-3.09|<0.001
91575470|NCT02209181|183039487|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.48||0.973|TWO_SIDED|95.0|-0.93|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.93|0.973
91575471|NCT02209181|183039488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.87|3.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.87|1.87|<0.001
91575472|NCT02209181|183039488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.5||0.079|TWO_SIDED|95.0|-0.1|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|-0.10|0.079
91575473|NCT02209181|183039488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|2.27|4.27||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.27|2.27|<0.001
91575474|NCT02209181|183039488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.98|-1.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.00|-2.98|<0.001
91575475|NCT02209181|183039488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.51||0.44|TWO_SIDED|95.0|-0.61|1.4||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.40|-0.61|0.440
91575476|NCT02209181|183039489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.52|3.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.57|1.52|<0.001
91575477|NCT02209181|183039489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.118|TWO_SIDED|95.0|-0.21|1.83||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.83|-0.21|0.118
91575478|NCT02209181|183039489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.16|2.10|<0.001
91575479|NCT02209181|183039489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.75|-0.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.71|-2.75|<0.001
91575480|NCT02209181|183039489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.262|TWO_SIDED|95.0|-0.44|1.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.62|-0.44|0.262
91575481|NCT02209181|183039490|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|0.88|2.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.96|0.88|<0.001
91575482|NCT02209181|183039490|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.52||0.271|TWO_SIDED|95.0|-0.45|1.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.61|-0.45|0.271
91575483|NCT02209181|183039490|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.95|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.91|3.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.99|1.91|<0.001
91575484|NCT02209181|183039490|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.52||0.011|TWO_SIDED|95.0|-2.37|-0.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.32|-2.37|0.011
91575485|NCT02209181|183039490|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.53||0.052|TWO_SIDED|95.0|-0.01|2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.07|-0.01|0.052
91575486|NCT02209181|183039491|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|0.21|2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.29|0.21|0.018
91575487|NCT02209181|183039491|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.52||0.31|TWO_SIDED|95.0|-0.5|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.50|0.310
91575488|NCT02209181|183039491|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.76|3.85||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.85|1.76|<0.001
91575489|NCT02209181|183039491|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.52||0.172|TWO_SIDED|95.0|-1.75|0.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.75|0.172
91575490|NCT02209181|183039491|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.55|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|0.51|2.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.60|0.51|0.004
91575491|NCT02209181|183039492|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.51||0.102|TWO_SIDED|95.0|-0.17|1.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.84|-0.17|0.102
91575492|NCT02209181|183039492|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.51||0.479|TWO_SIDED|95.0|-0.64|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.64|0.479
91575493|NCT02209181|183039492|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.85|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.85|<0.001
91575494|NCT02209181|183039492|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.51||0.345|TWO_SIDED|95.0|-1.47|0.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-1.47|0.345
91575495|NCT02209181|183039492|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.01|3.02||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.02|1.01|<0.001
91575496|NCT02209181|183039493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.338|TWO_SIDED|95.0|-0.52|1.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.51|-0.52|0.338
91575497|NCT02209181|183039493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.51||0.299|TWO_SIDED|95.0|-0.47|1.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.54|-0.47|0.299
91575498|NCT02209181|183039493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.7|3.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.73|1.70|<0.001
91575499|NCT02209181|183039493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.942|TWO_SIDED|95.0|-0.97|1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.04|-0.97|0.942
91575500|NCT02209181|183039493|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.21|3.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.24|1.21|<0.001
91575501|NCT02209181|183039494|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.51||0.306|TWO_SIDED|95.0|-0.48|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.48|0.306
91575502|NCT02209181|183039494|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.335|TWO_SIDED|95.0|-0.51|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|-0.51|0.335
91575503|NCT02209181|183039494|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.78|3.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.80|1.78|<0.001
91575504|NCT02209181|183039494|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.51||0.946|TWO_SIDED|95.0|-1.03|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-1.03|0.946
91575505|NCT02209181|183039494|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.25|3.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.28|1.25|<0.001
91575506|NCT02209181|183039495|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.279|TWO_SIDED|95.0|-0.45|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.45|0.279
91575507|NCT02209181|183039495|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.51||0.292|TWO_SIDED|95.0|-0.46|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.46|0.292
91575508|NCT02209181|183039495|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.66|3.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.68|1.66|<0.001
91575509|NCT02209181|183039495|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.51||0.971|TWO_SIDED|95.0|-1.02|0.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.98|-1.02|0.971
91575510|NCT02209181|183039495|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.11|3.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.12|1.11|<0.001
91575511|NCT02209181|183039496|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.329|TWO_SIDED|95.0|-0.5|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-0.50|0.329
91575512|NCT02209181|183039496|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.5||0.531|TWO_SIDED|95.0|-0.68|1.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.31|-0.68|0.531
91575513|NCT02209181|183039496|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.53|3.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.54|1.53|<0.001
91575514|NCT02209181|183039496|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.5||0.722|TWO_SIDED|95.0|-1.17|0.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.81|-1.17|0.722
91575515|NCT02209181|183039496|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.03|3.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.04|1.03|<0.001
91575516|NCT02209181|183039497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.5||0.38|TWO_SIDED|95.0|-0.54|1.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.42|-0.54|0.380
91575517|NCT02209181|183039497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.49||0.767|TWO_SIDED|95.0|-0.83|1.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.12|-0.83|0.767
91575518|NCT02209181|183039497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.52|3.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.49|1.52|<0.001
91575519|NCT02209181|183039497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.49||0.557|TWO_SIDED|95.0|-1.27|0.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.68|-1.27|0.557
91575520|NCT02209181|183039497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.08|3.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.05|1.08|<0.001
91575521|NCT02209181|183039498|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.55||0.64|TWO_SIDED|95.0|-0.83|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.83|0.640
91575522|NCT02209181|183039498|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.55||0.798|TWO_SIDED|95.0|-0.94|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-0.94|0.798
91575523|NCT02209181|183039498|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.32|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.23|3.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.42|1.23|<0.001
91575524|NCT02209181|183039498|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.55||0.829|TWO_SIDED|95.0|-1.2|0.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-1.20|0.829
91575525|NCT02209181|183039498|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|0.97|3.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.16|0.97|<0.001
91575526|NCT02209181|183039499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.16||0.117|TWO_SIDED|95.0|-0.06|0.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.06|0.117
91575527|NCT02209181|183039499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.687|TWO_SIDED|95.0|-0.25|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.25|0.687
91575528|NCT02209181|183039499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.497|TWO_SIDED|95.0|-0.21|0.43||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.21|0.497
91575529|NCT02209181|183039499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.239|TWO_SIDED|95.0|-0.51|0.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.13|-0.51|0.239
91575530|NCT02209181|183039499|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.376|TWO_SIDED|95.0|-0.46|0.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.18|-0.46|0.376
91575531|NCT02209181|183039500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.78|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|1.14|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|1.14|<0.001
91575532|NCT02209181|183039500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.32||0.35|TWO_SIDED|95.0|-0.33|0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.94|-0.33|0.350
91575533|NCT02209181|183039500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.183|TWO_SIDED|95.0|-0.21|1.08||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.08|-0.21|0.183
91575534|NCT02209181|183039500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.11|-0.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.84|-2.11|<0.001
91575535|NCT02209181|183039500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.98|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.70|-1.98|<0.001
91575536|NCT02209181|183039501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|2.94|4.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.61|2.94|<0.001
91575537|NCT02209181|183039501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.42||0.037|TWO_SIDED|95.0|0.05|1.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.71|0.05|0.037
91575538|NCT02209181|183039501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.63|2.3||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.30|0.63|<0.001
91575539|NCT02209181|183039501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.73|-2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.07|-3.73|<0.001
91575540|NCT02209181|183039501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.15|-1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.47|-3.15|<0.001
91575541|NCT02209181|183039502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|3.43|5.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.25|3.43|<0.001
91575542|NCT02209181|183039502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.46||0.067|TWO_SIDED|95.0|-0.06|1.75||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.75|-0.06|0.067
91575543|NCT02209181|183039502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.26|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|1.34|3.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.17|1.34|<0.001
91575544|NCT02209181|183039502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.49|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.4|-2.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.59|-4.40|<0.001
91575545|NCT02209181|183039502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-3.0|-1.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.17|-3.00|<0.001
91575546|NCT02209181|183039503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.87|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|3.9|5.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.84|3.90|<0.001
91575547|NCT02209181|183039503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.49||0.023|TWO_SIDED|95.0|0.16|2.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.09|0.16|0.023
91575548|NCT02209181|183039503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.96|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.98|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|1.98|<0.001
91575549|NCT02209181|183039503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-4.71|-2.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.78|-4.71|<0.001
91575550|NCT02209181|183039503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.89|-0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.94|-2.89|<0.001
91575551|NCT02209181|183039504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.71|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|3.64|5.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.78|3.64|<0.001
91575552|NCT02209181|183039504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.54||0.012|TWO_SIDED|95.0|0.3|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|0.30|0.012
91575553|NCT02209181|183039504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.66|4.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.81|2.66|<0.001
91575554|NCT02209181|183039504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|-4.41|-2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.29|-4.41|<0.001
91575555|NCT02209181|183039504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.54||0.074|TWO_SIDED|95.0|-2.05|0.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.09|-2.05|0.074
91575556|NCT02209181|183039505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|2.63|4.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.97|2.63|<0.001
91575557|NCT02209181|183039505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.026|TWO_SIDED|95.0|0.16|2.48||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.48|0.16|0.026
91575558|NCT02209181|183039505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.82|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|2.64|4.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.99|2.64|<0.001
91575559|NCT02209181|183039505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.64|-1.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.32|-3.64|<0.001
91575560|NCT02209181|183039505|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.6||0.978|TWO_SIDED|95.0|-1.16|1.19||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.19|-1.16|0.978
91575561|NCT02209181|183039506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.18|4.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.62|2.18|<0.001
91575562|NCT02209181|183039506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.61||0.081|TWO_SIDED|95.0|-0.13|2.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.28|-0.13|0.081
91575563|NCT02209181|183039506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.69|5.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.14|2.69|<0.001
91575564|NCT02209181|183039506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.53|-1.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.11|-3.53|<0.001
91575565|NCT02209181|183039506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.62||0.407|TWO_SIDED|95.0|-0.71|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.71|0.407
91575566|NCT02209181|183039507|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.56|4.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.10|1.56|<0.001
91575567|NCT02209181|183039507|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.64||0.17|TWO_SIDED|95.0|-0.38|2.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.14|-0.38|0.170
91575568|NCT02209181|183039507|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.33|4.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.87|2.33|<0.001
91575569|NCT02209181|183039507|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.64||0.002|TWO_SIDED|95.0|-3.21|-0.69||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.69|-3.21|0.002
91575570|NCT02209181|183039507|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.65||0.235|TWO_SIDED|95.0|-0.5|2.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.04|-0.50|0.235
91575571|NCT02209181|183039508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.65||0.001|TWO_SIDED|95.0|0.82|3.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.39|0.82|0.001
91575572|NCT02209181|183039508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.65||0.355|TWO_SIDED|95.0|-0.68|1.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.87|-0.68|0.355
91575573|NCT02209181|183039508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.36|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.07|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.07|<0.001
91575574|NCT02209181|183039508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.65||0.021|TWO_SIDED|95.0|-2.78|-0.23||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.23|-2.78|0.021
91575575|NCT02209181|183039508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.65||0.056|TWO_SIDED|95.0|-0.03|2.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.55|-0.03|0.056
91575576|NCT02209181|183039509|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|0.66||0.067|TWO_SIDED|95.0|-0.09|2.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.50|-0.09|0.067
91575577|NCT02209181|183039509|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.65||0.547|TWO_SIDED|95.0|-0.89|1.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.68|-0.89|0.547
91575578|NCT02209181|183039509|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.16|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|1.86|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|1.86|<0.001
91575579|NCT02209181|183039509|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.65||0.214|TWO_SIDED|95.0|-2.1|0.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.47|-2.10|0.214
91575580|NCT02209181|183039509|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96|STANDARD_ERROR_OF_MEAN|0.66||0.003|TWO_SIDED|95.0|0.66|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|0.66|0.003
91575581|NCT02209181|183039510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.64||0.281|TWO_SIDED|95.0|-0.57|1.95||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.95|-0.57|0.281
91575582|NCT02209181|183039510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.63||0.729|TWO_SIDED|95.0|-1.03|1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.47|-1.03|0.729
91575583|NCT02209181|183039510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.21|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.95|4.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.47|1.95|<0.001
91575584|NCT02209181|183039510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.63||0.459|TWO_SIDED|95.0|-1.72|0.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-1.72|0.459
91575585|NCT02209181|183039510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.26|3.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.78|1.26|<0.001
91575586|NCT02209181|183039511|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.65||0.674|TWO_SIDED|95.0|-1.0|1.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.55|-1.00|0.674
91575587|NCT02209181|183039511|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.64||0.417|TWO_SIDED|95.0|-0.74|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.74|0.417
91575588|NCT02209181|183039511|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.77|4.33||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.33|1.77|<0.001
91575589|NCT02209181|183039511|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.64||0.698|TWO_SIDED|95.0|-1.02|1.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.52|-1.02|0.698
91575590|NCT02209181|183039511|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.49|4.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.05|1.49|<0.001
91575591|NCT02209181|183039512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.64||0.541|TWO_SIDED|95.0|-0.87|1.66||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.66|-0.87|0.541
91575592|NCT02209181|183039512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.64||0.409|TWO_SIDED|95.0|-0.73|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.73|0.409
91575593|NCT02209181|183039512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.12|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.85|4.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.39|1.85|<0.001
91575594|NCT02209181|183039512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.64||0.834|TWO_SIDED|95.0|-1.12|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.12|0.834
91575595|NCT02209181|183039512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.45|4.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.00|1.45|<0.001
91575596|NCT02209181|183039513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.573|TWO_SIDED|95.0|-0.9|1.63||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.63|-0.90|0.573
91575597|NCT02209181|183039513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.448|TWO_SIDED|95.0|-0.77|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.77|0.448
91575598|NCT02209181|183039513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.98|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.71|4.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.25|1.71|<0.001
91575599|NCT02209181|183039513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.64||0.848|TWO_SIDED|95.0|-1.13|1.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.38|-1.13|0.848
91575600|NCT02209181|183039513|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.35|3.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.89|1.35|<0.001
91575601|NCT02209181|183039514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.64||0.72|TWO_SIDED|95.0|-1.04|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.04|0.720
91575602|NCT02209181|183039514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.64||0.763|TWO_SIDED|95.0|-1.07|1.45||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.45|-1.07|0.763
91575603|NCT02209181|183039514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.82|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.55|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|1.55|<0.001
91575604|NCT02209181|183039514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.64||0.952|TWO_SIDED|95.0|-1.3|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.30|0.952
91575605|NCT02209181|183039514|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.59|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.31|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.31|<0.001
91575606|NCT02209181|183039515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.63||0.821|TWO_SIDED|95.0|-1.1|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.10|0.821
91575607|NCT02209181|183039515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.63||0.978|TWO_SIDED|95.0|-1.25|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.25|0.978
91575608|NCT02209181|183039515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.63|4.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.13|1.63|<0.001
91575609|NCT02209181|183039515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.63||0.799|TWO_SIDED|95.0|-1.39|1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.07|-1.39|0.799
91575610|NCT02209181|183039515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.49|3.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.98|1.49|<0.001
91575611|NCT02209181|183039516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.7||0.726|TWO_SIDED|95.0|-1.62|1.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.13|-1.62|0.726
91575612|NCT02209181|183039516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.69||0.869|TWO_SIDED|95.0|-1.48|1.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.25|-1.48|0.869
91575613|NCT02209181|183039516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.13|3.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.90|1.13|<0.001
91575614|NCT02209181|183039516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.69||0.851|TWO_SIDED|95.0|-1.24|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.24|0.851
91575615|NCT02209181|183039516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.76|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.38|4.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.15|1.38|<0.001
91575616|NCT02209181|183039517|SUPERIORITY_OR_OTHER|||||||0.042||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.042
91575617|NCT02209181|183039517|SUPERIORITY_OR_OTHER|||||||0.779||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.779
91575618|NCT02209181|183039517|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||<0.001
91575619|NCT02209181|183039517|SUPERIORITY_OR_OTHER|||||||0.196||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.196
91575620|NCT02209181|183039517|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.006
91575621|NCT02209181|183039518|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|1.1|1.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.9|1.1|<0.001
91575622|NCT02209181|183039518|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.077|TWO_SIDED|95.0|0.0|0.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.8|-0.0|0.077
91575623|NCT02209181|183039518|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|0.8|1.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.6|0.8|<0.001
91575624|NCT02209181|183039518|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.6|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.7|-1.6|<0.001
91575625|NCT02209181|183039518|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.148|TWO_SIDED|95.0|-0.7|0.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.1|-0.7|0.148
91575626|NCT05239598|183039553|SUPERIORITY||Mean Difference (Net)|4.5||||0.287|TWO_SIDED|95.0|-4.0|13.0|||t-test, 2 sided|||||13.0|-4.0|0.287
91575627|NCT05239598|183039554|SUPERIORITY||Mean Difference (Net)|1.7||||0.625|TWO_SIDED|95.0|-5.2|8.6|||t-test, 2 sided|||5 minutes post intervention||8.6|-5.2|0.625
91575628|NCT05239598|183039554|SUPERIORITY||Mean Difference (Net)|2.5||||0.526|TWO_SIDED|95.0|-5.5|10.5|||t-test, 2 sided|||30 minutes post intervention||10.5|-5.5|0.526
91575629|NCT05239598|183039555|SUPERIORITY||Median Difference (Net)|0.04||||0.511|TWO_SIDED|95.0|-4.2|8.1|||Signed Rank|||Povidone-iodine: 5 minutes Post-Intervention||8.1|-4.2|0.511
91575630|NCT05239598|183039555|SUPERIORITY||Median Difference (Net)|5.4||||0.408|TWO_SIDED|95.0|-10.7|18.6|||Signed Rank|||Povidone-iodine: 30 minutes post-intervention||18.6|-10.7|0.408
91575631|NCT05239598|183039555|SUPERIORITY||Median Difference (Net)|-4.9||||0.907|TWO_SIDED|95.0|-15.2|17.5|||Signed Rank|||Povidone-iodine: 60 minutes post-intervention||17.5|-15.2|0.907
91575632|NCT05239598|183039555|SUPERIORITY||Median Difference (Net)|-2.4||||0.008|TWO_SIDED|95.0|-6.5|-0.9|||Signed Rank|||Placebo: 5 minutes post intervention||-0.9|-6.5|0.008
91575633|NCT05239598|183039555|SUPERIORITY||Median Difference (Net)|-6.6||||0.08|TWO_SIDED|95.0|-10.1|-2.2|||Signed Rank|||Placebo: 30 minutes post-intervention||-2.2|-10.1|0.080
91575634|NCT05239598|183039555|SUPERIORITY||Median Difference (Net)|-8.6||||0.001|TWO_SIDED|95.0|-22.3|-3.9|||Signed Rank|||Placebo: 60 minutes post-intervention||-3.9|-22.3|0.001
91575635|NCT05239598|183039556|SUPERIORITY||Median Difference (Net)|3.1||||0.212|TWO_SIDED|95.0|-2.2|5.8|||Signed Rank|||Povidone-iodine 5 minutes post-intervention||5.8|-2.2|0.212
91575636|NCT05239598|183039556|SUPERIORITY||Median Difference (Net)|1.8||||0.334|TWO_SIDED|95.0|-2.3|6.9|||Signed Rank|||Povidone-iodine 30 minutes post-intervention||6.9|-2.3|0.334
91575637|NCT05239598|183039556|SUPERIORITY||Median Difference (Net)|1.5||||0.269|TWO_SIDED|95.0|-3.1|6.8|||Signed Rank|||Povidone-iodine 60 minutes post-intervention||6.8|-3.1|0.269
91575638|NCT05239598|183039556|SUPERIORITY||Median Difference (Net)|-4.1||||0.026|TWO_SIDED|95.0|-7.1|-0.7|||Signed Rank|||Placebo 5 minutes post-intervention||-0.7|-7.1|0.026
91575639|NCT05239598|183039556|SUPERIORITY||Median Difference (Net)|-0.7||||0.182|TWO_SIDED|95.0|-9.4|2.0|||Signed Rank|||Placebo 30 minutes post-intervention||2.0|-9.4|0.182
91575640|NCT05239598|183039556|SUPERIORITY||Median Difference (Net)|-3.6||||0.353|TWO_SIDED|95.0|-7.7|4.0|||Signed Rank|||Placebo 60 minutes post-intervention||4.0|-7.7|0.353
91575641|NCT04855734|183039582|SUPERIORITY||Mean ratio|0.962||||0.835|TWO_SIDED|95.0|0.661|1.396||Threshold for significance was \<0.05.|Mixed Models Analysis|||||1.396|0.661|0.835
91575642|NCT04855734|183039583|SUPERIORITY||Mean ratio|0.826||||0.032|TWO_SIDED|95.0|0.75|0.986||\<0.05 was threshold for significance level.|Mixed Models Analysis|||Meaning/Peace subscale which was a primary outcome.||0.986|0.75|0.032
91575643|NCT04855734|183039589|SUPERIORITY||Mean ratio|1.052||||0.284|TWO_SIDED|95.0|0.959|1.157||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver strain subscale scores at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||1.157|0.959|0.284
91575644|NCT04855734|183039589|SUPERIORITY||Mean ratioj|0.931||||0.228|TWO_SIDED|95.0|0.827|1.048||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver distress subscale controlling for baseline levels.||1.048|0.827|0.228
91575645|NCT04855734|183039589|SUPERIORITY||Mean ratio|0.984||||0.504|TWO_SIDED|95.0|0.94|1.032||\<0.05 significance level.|Mixed Models Analysis|||Family well-being subscale controlling for baseline levels.||1.032|0.94|0.504
91575646|NCT04855734|183039589|SUPERIORITY||Mean ratio|0.995||||0.741|TWO_SIDED|95.0|0.967|1.024||\<0.05 significance level.|Mixed Models Analysis|||Positive Caregiving Appraisals subscale at 3 month follow up, controlling for baseline levels.||1.024|0.967|0.741
91575647|NCT03832595|183039597|EQUIVALENCE|We determined that 1,653 patients provide 80% power to detect a hazard ratio of 0.64, or a 5% absolute risk reduction in intervention arm, assuming a primary end-point rate of 15% in the usual care group at 24 months, 20% loss to follow-up, α = 0.05, and within-practice intra-class correlation of 0.01|Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38|||Mixed Models Analysis|||||1.38|0.67|0.82
91575648|NCT03832595|183039598|EQUIVALENCE|α = 0.05|Slope difference|0.011|||||TWO_SIDED|95.0|-0.008|0.029||||||||0.029|-0.008|
91575649|NCT03832595|183039599|EQUIVALENCE|α = 0.05|Rate ratio|1.21|||||TWO_SIDED|95.0|1.02|1.43||||||||1.43|1.02|
91575650|NCT03832595|183039600|EQUIVALENCE|α = 0.05|Rate ratio|0.8|||||TWO_SIDED|95.0|0.51|1.25||||||||1.25|0.51|
91575651|NCT03832595|183039601|EQUIVALENCE|α = 0.05|Rate ratio|1.18|||||TWO_SIDED|95.0|0.03|53.78||||||||53.78|0.03|
91575652|NCT03832595|183039602|EQUIVALENCE|α = 0.05|Rate ratio|1.12|||||TWO_SIDED|95.0|0.12|9.96||||||||9.96|0.12|
91575653|NCT03939689|183039632|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test with adjustment for stratification factor (prostate cancer risk factor at Screening) was carried out by using complete cases for the FAS population (missing data were not imputed for this analysis). Intermediate risk at Screening: hemoglobin (Hgb) ≥11 g/dL and LDH \<262 IU/L and ALP \<414 IU/L. High-risk at Screening: Hgb \<11 g/dL or LDH ≥262 IU/L or ALP ≥414 IU/L.||||0.0025
91575654|NCT03939689|183039633|SUPERIORITY|||||||0.806||||||The p-value is based on the chi-squared test of the difference in proportions between treatment groups if expected cell frequencies are all greater than 5; otherwise, the p-value is from the Fisher's exact test.|Chi-squared|||||||0.8060
91575655|NCT03939689|183039634|SUPERIORITY|||||||0.5924||||||Log-rank test of no difference between treatment groups, stratified by prostate cancer risk groups.|Log Rank|||Kaplan-Meier analysis and Greenwood formula used for estimating event-free rates and 95% confidence intervals.||||.5924
91575656|NCT03939689|183039635|SUPERIORITY|||||||0.5924||||||Log-rank test of no difference between treatment groups, stratified by prostate cancer risk groups.|Log Rank|||Kaplan-Meier analysis and Greenwood formula used for estimating event-free rates and 95% confidence intervals.||||0.5924
91575657|NCT03939689|183039636|SUPERIORITY|||||||0.6199||||||P value from the log-rank test of no difference between treatment groups, stratified by prostate cancer risk group at Screening.|Log Rank|||Event-free rates and 95% CI were estimated by using Kaplan-Meier method and Greenwood formula.||||0.6199
91575658|NCT03939689|183039637|SUPERIORITY|||||||0.1823||||||P-value from the log-rank test of no difference between treatment groups, stratified by prostate cancer risk group at Screening.|Log Rank|||Event free rates and 95% CI were estimated by using Kaplan-Meier method and Greenwood formula.||||.1823
91575659|NCT03939689|183039638|SUPERIORITY|||||||0.0006||||||P-value from the log-rank test of no difference between treatment groups, stratified by prostate cancer risk group at Screening.|Log Rank|||Event-free rates and 95% CI were estimated by using Kaplan-Meier method and Greenwood formula.||||0.0006
91575660|NCT02473965|183039654|SUPERIORITY||Odds Ratio (OR)|0.868|||=|1|TWO_SIDED|95.0|0.27|2.787||The statistical inference was tested as 2-sided with alpha=0.05.|Fisher Exact|||An unstratified analysis using Fisher's exact test was used for treatment comparison without adjustment for stratified baseline prednisone equivalent dose level due to the small cell size. The odds ratio and confidence intervals are calculated overall (i.e. all mITT subjects).||2.787|0.270|=1.00
91575661|NCT02473965|183039655|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|12.536|=|0.9|TWO_SIDED|95.0|-23.52|26.68|||ANCOVA|||Treatment comparison of percent change in daily CS dose from baseline to Week 39. The Analysis of Covariance model included the percent change from baseline in daily CS dose as the dependent variable, treatment as a fixed effect and baseline daily CS dose as covariate.||26.68|-23.52|=0.900
91575662|NCT02271984|183039677|SUPERIORITY_OR_OTHER||Ratio (%)|39.9|||||TWO_SIDED|90.0|34.7|46.0|||||Percentage of Geometric Least Squares (LS) Mean Ratio (Treatment A/Treatment B) is reported.|||46.0|34.7|
91575663|NCT02271984|183039677|SUPERIORITY_OR_OTHER||Ratio (%)|27.3|||||TWO_SIDED|90.0|22.5|33.2|||||Percentage of Geometric LS Mean Ratio (Treatment C1/Treatment A) is reported.|||33.2|22.5|
91575664|NCT02271984|183039677|SUPERIORITY_OR_OTHER||Ratio (%)|260.2|||||TWO_SIDED|90.0|214.0|316.4|||||Percentage of Geometric LS Mean Ratio (Treatment C2/Treatment A) is reported.|||316.4|214.0|
91575665|NCT02271984|183039677|SUPERIORITY_OR_OTHER||Ratio (%)|167.1|||||TWO_SIDED|90.0|143.9|194.0|||||Percentage of Geometric LS Mean Ratio (Treatment A/Treatment D) is reported.|||194.0|143.9|
91575666|NCT02271984|183039677|SUPERIORITY_OR_OTHER||Ratio (%)|115.7|||||TWO_SIDED|90.0|99.8|134.1|||||Percentage of Geometric LS Mean Ratio (Treatment E/Treatment A) is reported.|||134.1|99.8|
91575667|NCT01088984|183039692|SUPERIORITY_OR_OTHER|||||||1||||||1-sided p-value is calculated against the null hypothesis of a response rate of 5%.|binomial parameter exact method|||||||1.0000
91575668|NCT02304705|183039705|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||.052
91575669|NCT00770029|183039710|SUPERIORITY_OR_OTHER||Difference response rate|0.6|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|0.52|0.68|||Fisher Exact|||The efficacy of the treatment was confirmed if H0 was rejected at a given α of 5%, that means if the two sided p-value was ≤0.05. Power of 90%||0.68|0.52|<0.0001
91575670|NCT05620108|183039716|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
91575671|NCT05602727|183039717|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|2.1||||0.186|TWO_SIDED|97.5|-1.6|5.8|||Longitudinal ANCOVA|||||5.8|-1.6|0.186
91575672|NCT05602727|183039717|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|-1.4||||0.4|TWO_SIDED|97.5|-5.2|2.4|||Longitudinal ANCOVA|||||2.4|-5.2|0.400
91575673|NCT05602727|183039721|SUPERIORITY|Difference in LS Means|LS Mean Difference|-2.9||||0.196|TWO_SIDED|97.5|-8.0|2.2|||Longitudinal ANCOVA|||||2.2|-8.0|0.196
91575674|NCT05602727|183039721|SUPERIORITY|Difference in LS Means|LS Mean Difference|-4.2||||0.081|TWO_SIDED|97.5|-9.6|1.3|||Longitudinal ANCOVA|||||1.3|-9.6|0.081
91575675|NCT02038842|183039725|OTHER|The co-primary immunogenicity endpoint is analysed per arm, in a frequentist framework, in all randomised participants having received at least one vaccine administration and still HIV-negative at W30.|||||=|0.02||||||One-sided test for the observed proportion being superior to the theoretical decision threshold of 50%.|Binomial|||Trial was designed to compare the observed proportion of responders at week 30 within each group to a predefined minimum immunogenicity level of 50%.||||=0.02
91575676|NCT05504954|183039728|SUPERIORITY||Odds Ratio (OR)|0.26||||0.15|TWO_SIDED|95.0|0.04|1.59|||Regression, Logistic|||||1.59|0.04|0.15
91575677|NCT05504954|183039730|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1|TWO_SIDED|95.0|0.81|9.89|||Regression, Logistic|||||9.89|0.81|0.10
91575678|NCT05504954|183039731|SUPERIORITY||beta coefficient|5.0||||0.65|TWO_SIDED|95.0|-17.78|27.78|||Regression, Linear|||||27.78|-17.78|0.65
91575679|NCT05504954|183039732|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
91575680|NCT05504954|183039733|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||.70
91575681|NCT05504954|183039734|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
91575682|NCT05504954|183039735|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
91575683|NCT03412773|183039748|NON_INFERIORITY|"Overall survival (OS) was compared between the tislelizumab group (Arm A) and the sorafenib group (Arm B) by testing the null hypothesis of noninferiority: the null hypothesis assumes the hazard ratio (HR) for tislelizumab versus sorafenib is greater than or equal to 1.08, while the alternative hypothesis assumes the hazard ratio is less than 1.08.~Noninferiority was declared if the upper limit of the 95.003% confidence interval (CI) for the HR was less than 1.08"|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.003|0.712|1.019|||||The hazard ratio is based on a Cox regression model with treatment, geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG (0 vs. 1) as covariates.|||1.019|0.712|
91575684|NCT03412773|183039748|SUPERIORITY|Superiority of tislelizumab over sorafenib was tested for OS using a stratified log-rank test in the ITT analysis set only when noninferiority was demonstrated. Superiority was declared if the one-sided p-value crosses the boundary of 0.0223 (1-sided p-value \< 0.0223) in favor of Arm A in the stratified log-rank test.|Hazard Ratio (HR)|0.85||||0.0398|TWO_SIDED|95.0|0.712|1.019||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|Log Rank||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.019|0.712|0.0398
91575685|NCT03412773|183039749|OTHER||Cochran-Mantel-Haenszel ORR difference|8.28||||0.0003|TWO_SIDED|95.0|3.85|12.7||The nominal P-value from the Cochran-Mantel-Haenszel chi-square test, conducted at a 0.05 significance level, was stratified by geography, macrovascular invasion/extrahepatic spread, etiology, and ECOG.|Cochran-Mantel-Haenszel|||The null hypothesis assumed that ORR is equal in both groups, while the alternative hypothesis assumed ORR is higher in the tislelizumab group (Arm A).||12.70|3.85|0.0003
91575686|NCT03412773|183039750|OTHER||Cochran-Mantel-Haenszel ORR difference|9.24|||<|0.0001|TWO_SIDED|95.0|4.71|13.78||The nominal P-value from the Cochran-Mantel-Haenszel chi-square test, conducted at a 0.05 significance level, was stratified by geography, macrovascular invasion/extrahepatic spread, etiology, and ECOG.|Cochran-Mantel-Haenszel|||||13.78|4.71|<0.0001
91575687|NCT03412773|183039751|OTHER||Hazard Ratio (HR)|1.11||||0.1364|TWO_SIDED|95.0|0.92|1.33||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.33|0.92|0.1364
91575688|NCT03412773|183039752|OTHER||Hazard Ratio (HR)|1.06||||0.2622|TWO_SIDED|95.0|0.9|1.26||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.26|0.90|0.2622
91575689|NCT03412773|183039755|OTHER||Hazard Ratio (HR)|1.14||||0.0859|TWO_SIDED|95.0|0.94|1.38||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.38|0.94|0.0859
91575690|NCT03412773|183039756|OTHER||Hazard Ratio (HR)|1.12||||0.1182|TWO_SIDED|95.0|0.94|1.34||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.34|0.94|0.1182
91575691|NCT03412773|183039762|OTHER||Least Squares (LS) Mean Difference|-2.3||||0.0033|TWO_SIDED|95.0|-3.8|-0.8||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||-0.8|-3.8|0.0033
91575692|NCT03412773|183039763|OTHER||LS Mean Difference|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||-0.7|-4.7|0.0096
91575693|NCT03412773|183039764|OTHER||LS Mean Difference|4.3||||0.0037|TWO_SIDED|95.0|1.4|7.3||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||7.3|1.4|0.0037
91575694|NCT03412773|183039765|OTHER||LS Mean Difference|5.0||||0.0022|TWO_SIDED|95.0|1.8|8.2||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||8.2|1.8|0.0022
91575695|NCT00847626|183039788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-9.5||Tested at 5% significance level.|ANCOVA|||Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-9.5|-15.8|<0.001
91575696|NCT00847626|183039788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.7|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.9|-16.7|<0.001
91575697|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|||<|0.001|TWO_SIDED|95.0|-16.2|-9.2||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.2|-16.2|<0.001
91575698|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.001|TWO_SIDED|95.0|-13.4|-6.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-6.4|-13.4|<0.001
91575699|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|||<|0.001|TWO_SIDED|95.0|-19.2|-12.1||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.1|-19.2|<0.001
91575700|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.001|TWO_SIDED|95.0|-15.8|-8.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.9|-15.8|<0.001
91575701|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|||<|0.001|TWO_SIDED|95.0|-19.3|-12.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.3|-19.3|<0.001
91575702|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-16.5|-9.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.5|-16.5|<0.001
91575703|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.5|-10.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.5|-17.5|<0.001
91575704|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-20.6|-13.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.7|-20.6|<0.001
91575705|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5|||<|0.001|TWO_SIDED|95.0|-17.0|-9.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.9|-17.0|<0.001
91575706|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||<|0.001|TWO_SIDED|95.0|-19.7|-12.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.7|-19.7|<0.001
91575707|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.3|-9.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.3|-16.3|<0.001
91575708|NCT00847626|183039789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-19.4|-12.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.6|-19.4|<0.001
91575709|NCT00847626|183039790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.255|TWO_SIDED|95.0|-13.0|3.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||3.5|-13.0|0.255
91575710|NCT00847626|183039790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-25.9|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.6|-25.9|<0.001
91575711|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.6|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.6|< 0.001
91575712|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.7|<0.001
91575713|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-15.1|-8.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.4|-15.1|<0.001
91575714|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|||<|0.001|TWO_SIDED|95.0|-17.3|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.6|-17.3|<0.001
91575715|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-17.1|-10.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.3|-17.1|<0.001
91575716|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|||<|0.001|TWO_SIDED|95.0|-15.4|-8.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.7|-15.4|<0.001
91575717|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-14.2|-7.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.6|-14.2|<0.001
91575718|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.001|TWO_SIDED|95.0|-17.6|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.9|-17.6|<0.001
91575719|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-15.0|-8.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.3|-15.0|<0.001
91575720|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-20.4|-13.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.6|-20.4|<0.001
91575721|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.7|-7.8||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.8|-14.7|<0.001
91575722|NCT00847626|183039803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.2|-9.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.4|-16.2|<0.001
91575723|NCT02942004|183039815|SUPERIORITY||Least Square (LS) Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|1.664||0.0013|TWO_SIDED|95.0|-8.8|-2.2|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.20|-8.80|0.0013
91575724|NCT02942004|183039815|SUPERIORITY||LS mean difference|-3.68|STANDARD_ERROR_OF_MEAN|1.622||0.0252|TWO_SIDED|95.0|-6.9|-0.47|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.47|-6.90|0.0252
91575725|NCT02942004|183039816|SUPERIORITY||LS mean difference|-5.63|STANDARD_ERROR_OF_MEAN|1.936||0.0044|TWO_SIDED|95.0|-9.46|-1.79|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.79|-9.46|0.0044
91575726|NCT02942004|183039816|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.899||0.0481|TWO_SIDED|95.0|-7.56|-0.03|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-7.56|0.0481
91575727|NCT02942004|183039817|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.951||0.9591|TWO_SIDED|95.0|-1.83|1.93|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.93|-1.83|0.9591
91575728|NCT02942004|183039817|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.917||0.8677|TWO_SIDED|95.0|-1.66|1.97|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-1.66|0.8677
91575729|NCT02942004|183039817|SUPERIORITY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|1.208||0.0827|TWO_SIDED|95.0|-4.51|0.28|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-4.51|0.0827
91575730|NCT02942004|183039817|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.172||0.7968|TWO_SIDED|95.0|-2.62|2.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.02|-2.62|0.7968
91575731|NCT02942004|183039817|SUPERIORITY||LS mean difference|-2.04|STANDARD_ERROR_OF_MEAN|1.336||0.1292|TWO_SIDED|95.0|-4.69|0.61|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.61|-4.69|0.1292
91575732|NCT02942004|183039817|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.299||0.7801|TWO_SIDED|95.0|-2.94|2.21|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.21|-2.94|0.7801
91575733|NCT02942004|183039817|SUPERIORITY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|1.436||0.384|TWO_SIDED|95.0|-4.1|1.59|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.59|-4.10|0.3840
91575734|NCT02942004|183039817|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.395||0.6097|TWO_SIDED|0.71|-2.05|3.48|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.48|-2.05|0.6097
91575735|NCT02942004|183039817|SUPERIORITY||LS mean difference|-4.28|STANDARD_ERROR_OF_MEAN|1.622||0.0094|TWO_SIDED|95.0|-7.5|-1.07|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.07|-7.50|0.0094
91575736|NCT02942004|183039817|SUPERIORITY||LS mean difference|-2.32|STANDARD_ERROR_OF_MEAN|1.577||0.144|TWO_SIDED|95.0|-5.45|0.8|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.80|-5.45|0.1440
91575737|NCT02942004|183039817|SUPERIORITY||LS mean difference|-5.12|STANDARD_ERROR_OF_MEAN|1.62||0.002|TWO_SIDED|95.0|-8.33|-1.91|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.91|-8.33|0.0020
91575738|NCT02942004|183039817|SUPERIORITY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.572||0.3906|TWO_SIDED|95.0|-4.47|1.76|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.76|-4.47|0.3906
91575739|NCT02942004|183039817|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.735||0.011|TWO_SIDED|95.0|-7.93|-1.05|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.05|-7.93|0.0110
91575740|NCT02942004|183039817|SUPERIORITY||LS mean difference|-3.33|STANDARD_ERROR_OF_MEAN|1.69||0.0511|TWO_SIDED|95.0|-6.68|0.02|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-6.68|0.0511
91575741|NCT02942004|183039817|SUPERIORITY||LS mean difference|-5.02|STANDARD_ERROR_OF_MEAN|1.738||0.0046|TWO_SIDED|95.0|-8.47|-1.58|||MMRM|||Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.58|-8.47|0.0046
91575742|NCT02942004|183039817|SUPERIORITY||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|1.694||0.1389|TWO_SIDED|95.0|-5.88|0.83|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-5.88|0.1389
91575743|NCT02942004|183039817|SUPERIORITY||LS mean difference|-4.07|STANDARD_ERROR_OF_MEAN|1.837||0.0288|TWO_SIDED|95.0|-7.71|-0.43|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.43|-7.71|0.0288
91575744|NCT02942004|183039817|SUPERIORITY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.797||0.3799|TWO_SIDED|95.0|-5.15|1.98|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.98|-5.15|0.3799
91575745|NCT02942004|183039817|SUPERIORITY||LS mean difference|-2.92|STANDARD_ERROR_OF_MEAN|2.139||0.1747|TWO_SIDED|95.0|-7.16|1.32|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.32|-7.16|0.1747
91575746|NCT02942004|183039817|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|2.08||0.631|TWO_SIDED|95.0|-5.13|3.12|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.12|-5.13|0.6310
91575747|NCT02942004|183039817|SUPERIORITY||LS mean difference|-4.92|STANDARD_ERROR_OF_MEAN|2.045||0.0178|TWO_SIDED|95.0|-8.98|-0.87|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.87|-8.98|0.0178
91575748|NCT02942004|183039817|SUPERIORITY||LS mean difference|-3.51|STANDARD_ERROR_OF_MEAN|1.976||0.0786|TWO_SIDED|95.0|-7.43|0.41|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-7.43|0.0786
91575749|NCT02942004|183039818|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0052|TWO_SIDED|95.0|1.7|17.4|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.4|1.7|0.0052
91575750|NCT02942004|183039818|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0493|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.9|1.0|0.0493
91575751|NCT02942004|183039818|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0572|TWO_SIDED|95.0|1.0|6.5|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.5|1.0|0.0572
91575752|NCT02942004|183039818|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6768|TWO_SIDED|95.0|0.5|3.0|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.0|0.5|0.6768
91575753|NCT02942004|183039818|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0035|TWO_SIDED|95.0|1.7|16.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||16.8|1.7|0.0035
91575754|NCT02942004|183039818|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0347|TWO_SIDED|95.0|1.1|7.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.8|1.1|0.0347
91575755|NCT02942004|183039819|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0011|TWO_SIDED|95.0|2.1|17.8|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.8|2.1|0.0011
91575756|NCT02942004|183039819|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0828|TWO_SIDED|95.0|0.9|7.6|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.6|0.9|0.0828
91575757|NCT02942004|183039819|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7749|TWO_SIDED|95.0|0.4|3.1|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.1|0.4|0.7749
91575758|NCT02942004|183039819|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3401|TWO_SIDED|95.0|0.2|1.7|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||1.7|0.2|0.3401
91575759|NCT02942004|183039819|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1052|TWO_SIDED|95.0|0.8|6.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.0|0.8|0.1052
91575760|NCT02942004|183039819|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3507|TWO_SIDED|95.0|0.6|4.2|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||4.2|0.6|0.3507
91575761|NCT02942004|183039820|SUPERIORITY||LS mean difference|-12.07|STANDARD_ERROR_OF_MEAN|4.294||0.0058|TWO_SIDED|95.0|-20.58|-3.56|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-3.56|-20.58|0.0058
91575762|NCT02942004|183039820|SUPERIORITY||LS mean difference|-5.89|STANDARD_ERROR_OF_MEAN|4.188||0.1622|TWO_SIDED|95.0|-14.19|2.41|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||2.41|-14.19|0.1622
91575763|NCT02942004|183039820|SUPERIORITY||LS mean difference|-9.09|STANDARD_ERROR_OF_MEAN|4.51||0.0462|TWO_SIDED|95.0|-18.02|-0.16|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-0.16|-18.02|0.0462
91575764|NCT02942004|183039820|SUPERIORITY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|4.41||0.6124|TWO_SIDED|95.0|-10.97|6.49|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||6.49|-10.97|0.6124
91575765|NCT02942004|183039820|SUPERIORITY||LS mean difference|-11.68|STANDARD_ERROR_OF_MEAN|4.556||0.0116|TWO_SIDED|95.0|-20.71|-2.66|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-2.66|-20.71|0.0116
91575766|NCT02942004|183039820|SUPERIORITY||LS mean difference|-8.26|STANDARD_ERROR_OF_MEAN|4.464||0.0667|TWO_SIDED|95.0|-17.1|0.58|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||0.58|-17.10|0.0667
91575767|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191||0.9681|TWO_SIDED|95.0|-0.39|0.37|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.39|0.9681
91575768|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.185||0.6337|TWO_SIDED|95.0|-0.28|0.46|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.28|0.6337
91575769|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.469|TWO_SIDED|95.0|-0.64|0.3|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.64|0.4690
91575770|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.232||0.9905|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.46|0.9905
91575771|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3984|TWO_SIDED|95.0|-0.68|0.27|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.68|0.3984
91575772|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.234||0.7042|TWO_SIDED|95.0|-0.37|0.55|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.37|0.7042
91575773|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.247||0.4941|TWO_SIDED|95.0|-0.66|0.32|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.66|0.4941
91575774|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24||0.4572|TWO_SIDED|95.0|-0.3|0.65|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.65|-0.30|0.4572
91575775|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.236||0.9866|TWO_SIDED|95.0|-0.47|0.46|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.47|0.9866
91575776|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.229||0.749|TWO_SIDED|95.0|-0.53|0.38|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.53|0.7490
91575777|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.247||0.0235|TWO_SIDED|95.0|-1.06|-0.08|||MMRM|||Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-1.06|0.0235
91575778|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.239||0.9286|TWO_SIDED|95.0|-0.5|0.45|||MMRM|||Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.50|0.9286
91575779|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.251||0.0544|TWO_SIDED|95.0|-0.99|0.01|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.99|0.0544
91575780|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.244||0.2903|TWO_SIDED|95.0|-0.74|0.22|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.74|0.2903
91575781|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.244||0.0044|TWO_SIDED|95.0|-1.19|-0.23|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.19|0.0044
91575782|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.238||0.1339|TWO_SIDED|95.0|-0.83|0.11|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.83|0.1339
91575783|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.234||0.0149|TWO_SIDED|95.0|-1.04|-0.11|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-1.04|0.0149
91575784|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3213|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3213
91575785|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.246||0.0703|TWO_SIDED|95.0|-0.94|0.04|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.94|0.0703
91575786|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.8152|TWO_SIDED|95.0|-0.53|0.42|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.53|0.8152
91575787|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.301||0.0805|TWO_SIDED|95.0|-1.13|0.07|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-1.13|0.0805
91575788|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.291||0.6964|TWO_SIDED|95.0|-0.69|0.46|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.69|0.6964
91575789|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.304||0.2998|TWO_SIDED|95.0|-0.92|0.29|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.92|0.2998
91575790|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.291||0.3448|TWO_SIDED|95.0|-0.85|0.3|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.85|0.3448
91575791|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.248||0.0089|TWO_SIDED|95.0|-1.15|-0.17|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.15|0.0089
91575792|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.244||0.0772|TWO_SIDED|95.0|-0.92|0.05|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.92|0.0772
91575793|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.191||0.6809|TWO_SIDED|95.0|-0.46|0.3|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.46|0.6809
91575794|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.185||0.7297|TWO_SIDED|95.0|-0.3|0.43|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.30|0.7297
91575795|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0626|TWO_SIDED|95.0|-0.87|0.02|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.87|0.0626
91575796|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5196|TWO_SIDED|95.0|-0.58|0.29|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.58|0.5196
91575797|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.234||0.0772|TWO_SIDED|95.0|-0.88|0.05|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.88|0.0772
91575798|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.228||0.661|TWO_SIDED|95.0|-0.55|0.35|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.55|0.6610
91575799|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.239||0.4007|TWO_SIDED|95.0|-0.67|0.27|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.67|0.4007
91575800|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.232||0.2292|TWO_SIDED|95.0|-0.18|0.74|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.74|-0.18|0.2292
91575801|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.234||0.054|TWO_SIDED|95.0|-0.92|0.01|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.92|0.0540
91575802|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.227||0.959|TWO_SIDED|95.0|-0.44|0.46|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.44|0.9590
91575803|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.218||0.1048|TWO_SIDED|95.0|-0.79|0.08|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.79|0.1048
91575804|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8979|TWO_SIDED|95.0|-0.44|0.39|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.44|0.8979
91575805|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.219||0.0819|TWO_SIDED|95.0|-0.82|0.05|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.82|0.0819
91575806|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.213||0.1099|TWO_SIDED|95.0|-0.77|0.08|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.77|0.1099
91575807|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0373|TWO_SIDED|95.0|-0.88|-0.03|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.88|0.0373
91575808|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.209||0.0577|TWO_SIDED|95.0|-0.81|0.01|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.81|0.0577
91575809|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2023|TWO_SIDED|95.0|-0.69|0.15|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.69|0.2023
91575810|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.204||0.4444|TWO_SIDED|95.0|-0.56|0.25|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.56|0.4444
91575811|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3645|TWO_SIDED|95.0|-0.64|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.64|0.3645
91575812|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.214||0.4035|TWO_SIDED|95.0|-0.6|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.60|0.4035
91575813|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.232||0.4877|TWO_SIDED|95.0|-0.62|0.3|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.62|0.4877
91575814|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.226||0.3134|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3134
91575815|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.24||0.0922|TWO_SIDED|95.0|-0.89|0.07|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.89|0.0922
91575816|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.23||0.0761|TWO_SIDED|95.0|-0.87|0.04|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.87|0.0761
91575817|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3275|TWO_SIDED|95.0|-0.64|0.22|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.64|0.3275
91575818|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.213||0.3041|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3041
91575819|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.045|TWO_SIDED|95.0|-0.59|-0.01|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.59|0.0450
91575820|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.5351|TWO_SIDED|95.0|-0.19|0.37|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.19|0.5351
91575821|NCT02942004|183039821|SUPERIORITY||LS men difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0525|TWO_SIDED|95.0|-0.56|0.0|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.56|0.0525
91575822|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.139||0.7932|TWO_SIDED|95.0|-0.24|0.31|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.24|0.7932
91575823|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.128||0.13|TWO_SIDED|95.0|-0.45|0.06|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.45|0.1300
91575824|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.125||0.1631|TWO_SIDED|95.0|-0.07|0.42|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.07|0.1631
91575825|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.129||0.8215|TWO_SIDED|95.0|-0.23|0.29|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.23|0.8215
91575826|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.126||0.038|TWO_SIDED|95.0|0.01|0.51|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|0.01|0.0380
91575827|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.124||0.507|TWO_SIDED|95.0|-0.33|0.16|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.33|0.5070
91575828|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1094|TWO_SIDED|95.0|-0.04|0.43|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.04|0.1094
91575829|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.3112|TWO_SIDED|95.0|-0.3|0.1|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.30|0.3112
91575830|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.096||0.1345|TWO_SIDED|95.0|-0.05|0.33|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.05|0.1345
91575831|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.5148|TWO_SIDED|95.0|-0.24|0.12|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.24|0.5148
91575832|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.088||0.3863|TWO_SIDED|95.0|-0.25|0.1|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.25|0.3863
91575833|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0209|TWO_SIDED|95.0|-0.41|-0.03|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.41|0.0209
91575834|NCT02942004|183039821|SUPERIORITY||LS men difference|-0.17|STANDARD_ERROR_OF_MEAN|0.092||0.0616|TWO_SIDED|95.0|-0.35|0.01|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.35|0.0616
91575835|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.099||0.186|TWO_SIDED|95.0|-0.33|0.06|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.33|0.1860
91575836|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.095||0.773|TWO_SIDED|95.0|-0.22|0.16|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.22|0.7730
91575837|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1593|TWO_SIDED|95.0|-0.44|0.07|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.44|0.1593
91575838|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6371|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6371
91575839|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.5655|TWO_SIDED|95.0|-0.32|0.18|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.32|0.5655
91575840|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.121||0.3326|TWO_SIDED|95.0|-0.12|0.36|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.12|0.3326
91575841|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.201||0.3577|TWO_SIDED|95.0|-0.59|0.22|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.59|0.3577
91575842|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.1646|TWO_SIDED|95.0|-0.66|0.11|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.66|0.1646
91575843|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.118||0.0545|TWO_SIDED|95.0|-0.46|0.0|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.46|0.0545
91575844|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.115||0.2903|TWO_SIDED|95.0|-0.35|0.11|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.35|0.2903
91575845|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.112||0.0395|TWO_SIDED|95.0|0.01|0.45|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|0.01|0.0395
91575846|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.108||0.469|TWO_SIDED|95.0|-0.14|0.29|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.14|0.4690
91575847|NCT02942004|183039821|SUPERIORITY||LS difference|0.07|STANDARD_ERROR_OF_MEAN|0.139||0.6066|TWO_SIDED|95.0|-0.2|0.35|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.20|0.6066
91575848|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.136||0.9737|TWO_SIDED|95.0|-0.26|0.27|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.26|0.9737
91575849|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.148||0.403|TWO_SIDED|95.0|-0.17|0.42|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.17|0.4030
91575850|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.145||0.6357|TWO_SIDED|95.0|-0.36|0.22|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.36|0.6357
91575851|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8605|TWO_SIDED|95.0|-0.29|0.24|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.29|0.8605
91575852|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7534|TWO_SIDED|95.0|-0.3|0.22|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.30|0.7534
91575853|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.201||0.0021|TWO_SIDED|95.0|-1.03|-0.23|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.03|0.0021
91575854|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.196||0.0394|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0394
91575855|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.208||0.0039|TWO_SIDED|95.0|-1.03|-0.2|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.03|0.0039
91575856|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.1591|TWO_SIDED|95.0|-0.69|0.11|||MMRM|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.69|0.1591
91575857|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.1402|TWO_SIDED|95.0|-0.73|0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.73|0.1402
91575858|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.205||0.0143|TWO_SIDED|95.0|-0.91|-0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.91|0.0143
91575859|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.204||0.2293|TWO_SIDED|95.0|-0.65|0.16|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.65|0.2293
91575860|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0884|TWO_SIDED|95.0|-0.74|0.05|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.74|0.0884
91575861|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.207||0.0622|TWO_SIDED|95.0|-0.8|0.02|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.80|0.0622
91575862|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0955|TWO_SIDED|95.0|-0.74|0.06|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.74|0.0955
91575863|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0173|TWO_SIDED|95.0|-0.92|-0.09|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.92|0.0173
91575864|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.206||0.1687|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1687
91575865|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.258||0.3861|TWO_SIDED|95.0|-0.74|0.29|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.74|0.3861
91575866|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.249||0.706|TWO_SIDED|95.0|-0.59|0.4|||MMRM|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.59|0.7060
91575867|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0112|TWO_SIDED|95.0|-1.05|-0.14|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-1.05|0.0112
91575868|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.219||0.057|TWO_SIDED|95.0|-0.86|0.01|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.86|0.0570
91575869|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.208||0.0018|TWO_SIDED|95.0|-1.08|-0.26|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-1.08|0.0018
91575870|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.205||0.0443|TWO_SIDED|95.0|-0.83|-0.01|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.83|0.0443
91575871|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.104||0.1197|TWO_SIDED|95.0|-0.04|0.37|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.04|0.1197
91575872|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.101||0.7171|TWO_SIDED|95.0|-0.24|0.16|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.24|0.7171
91575873|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7151|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7151
91575874|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.521|TWO_SIDED|95.0|-0.35|0.18|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.35|0.5210
91575875|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.142||0.7332|TWO_SIDED|95.0|-0.23|0.33|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.23|0.7332
91575876|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.4163|TWO_SIDED|95.0|-0.39|0.16|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.39|0.4163
91575877|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.132||0.8625|TWO_SIDED|95.0|-0.28|0.24|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.28|0.8625
91575878|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6196|TWO_SIDED|95.0|-0.32|0.19|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.32|0.6196
91575879|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.197||0.0373|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0373
91575880|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.191||0.0644|TWO_SIDED|95.0|-0.74|0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.74|0.0644
91575881|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.191||0.1347|TWO_SIDED|95.0|-0.66|0.09|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.66|0.1347
91575882|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.185||0.1269|TWO_SIDED|95.0|-0.65|0.08|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.65|0.1269
91575883|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.165|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1650
91575884|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1291|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1291
91575885|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.189||0.0402|TWO_SIDED|95.0|-0.77|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.77|0.0402
91575886|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.185||0.0342|TWO_SIDED|95.0|-0.76|-0.03|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.76|0.0342
91575887|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.193||0.1269|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1269
91575888|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.188||0.3945|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3945
91575889|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.185||0.5828|TWO_SIDED|95.0|-0.47|0.26|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.47|0.5828
91575890|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.182||0.6625|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6625
91575891|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.07|-0.21|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.07|0.0041
91575892|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.2222|TWO_SIDED|95.0|-0.67|0.16|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.67|0.2222
91575893|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.218||0.0245|TWO_SIDED|95.0|-0.93|-0.07|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.93|0.0245
91575894|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.209||0.5119|TWO_SIDED|95.0|-0.55|0.28|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.55|0.5119
91575895|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.197||0.0299|TWO_SIDED|95.0|-0.82|-0.04|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.82|0.0299
91575896|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.195||0.2824|TWO_SIDED|95.0|-0.6|0.18|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.60|0.2824
91575897|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1768|TWO_SIDED|95.0|-0.08|0.43|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.08|0.1768
91575898|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6498|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6498
91575899|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.7689|TWO_SIDED|95.0|-0.25|0.34|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.25|0.7689
91575900|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.146||0.2236|TWO_SIDED|95.0|-0.47|0.11|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.47|0.2236
91575901|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.35|0.23|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.35|0.6952
91575902|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.144||0.1184|TWO_SIDED|95.0|-0.51|0.06|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.51|0.1184
91575903|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.149||0.3031|TWO_SIDED|95.0|-0.14|0.45|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.14|0.3031
91575904|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.145||0.3091|TWO_SIDED|95.0|-0.44|0.14|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.44|0.3091
91575905|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.179||0.1525|TWO_SIDED|95.0|-0.61|0.1|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.61|0.1525
91575906|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.174||0.1214|TWO_SIDED|95.0|-0.62|0.07|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.62|0.1214
91575907|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3811|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3811
91575908|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3851|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3851
91575909|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.182||0.1373|TWO_SIDED|95.0|-0.63|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.63|0.1373
91575910|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.136|TWO_SIDED|95.0|-0.62|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.62|0.1360
91575911|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.176||0.1264|TWO_SIDED|95.0|-0.62|0.08|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.62|0.1264
91575912|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.172||0.0567|TWO_SIDED|95.0|-0.67|0.01|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.67|0.0567
91575913|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.176||0.7447|TWO_SIDED|95.0|-0.41|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.41|0.7447
91575914|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.172||0.7727|TWO_SIDED|95.0|-0.39|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.39|0.7727
91575915|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.183||0.659|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6590
91575916|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.3951|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3951
91575917|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4576|TWO_SIDED|95.0|-0.63|0.28|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.63|0.4576
91575918|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.223||0.7609|TWO_SIDED|95.0|-0.51|0.37|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.51|0.7609
91575919|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.234||0.622|TWO_SIDED|95.0|-0.58|0.35|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.58|0.6220
91575920|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.9081|TWO_SIDED|95.0|-0.42|0.47|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.42|0.9081
91575921|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.191||0.1668|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1668
91575922|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.189||0.0935|TWO_SIDED|95.0|-0.69|0.05|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.69|0.0935
91575923|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.4038|TWO_SIDED|95.0|-0.42|0.17|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.42|0.4038
91575924|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.145||0.7559|TWO_SIDED|95.0|-0.24|0.33|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.24|0.7559
91575925|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.181||0.2006|TWO_SIDED|95.0|-0.59|0.13|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.59|0.2006
91575926|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.175||0.6334|TWO_SIDED|95.0|-0.26|0.43|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.26|0.6334
91575927|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.5431|TWO_SIDED|95.0|-0.6|0.32|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.60|0.5431
91575928|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.225||0.5278|TWO_SIDED|95.0|-0.3|0.59|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-0.30|0.5278
91575929|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4312|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4312
91575930|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.225||0.3947|TWO_SIDED|95.0|-0.25|0.64|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.64|-0.25|0.3947
91575931|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.244||0.6081|TWO_SIDED|95.0|-0.61|0.36|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.61|0.6081
91575932|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.238||0.8949|TWO_SIDED|95.0|-0.44|0.5|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.44|0.8949
91575933|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.236||0.112|TWO_SIDED|95.0|-0.84|0.09|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.84|0.1120
91575934|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.228||0.1842|TWO_SIDED|95.0|-0.15|0.76|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.15|0.1842
91575935|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.2646|TWO_SIDED|95.0|-0.81|0.22|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.81|0.2646
91575936|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.253||0.8101|TWO_SIDED|95.0|-0.56|0.44|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.56|0.8101
91575937|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.248||0.0215|TWO_SIDED|95.0|-1.07|-0.09|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-1.07|0.0215
91575938|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.242||0.3226|TWO_SIDED|95.0|-0.72|0.24|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.72|0.3226
91575939|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.238||0.0339|TWO_SIDED|95.0|-0.98|-0.04|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.98|0.0339
91575940|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9824|TWO_SIDED|95.0|-0.46|0.47|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.46|0.9824
91575941|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.254||0.095|TWO_SIDED|95.0|-0.93|0.08|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.93|0.0950
91575942|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.249||0.4865|TWO_SIDED|95.0|-0.67|0.32|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.67|0.4865
91575943|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.292||0.9861|TWO_SIDED|95.0|-0.57|0.58|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.57|0.9861
91575944|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.283||0.9266|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.54|-0.59|0.9266
91575945|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.285||0.036|TWO_SIDED|95.0|-1.17|-0.04|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-1.17|0.0360
91575946|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.273||0.0583|TWO_SIDED|95.0|-1.06|0.02|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-1.06|0.0583
91575947|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0404|TWO_SIDED|95.0|-1.03|-0.02|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-1.03|0.0404
91575948|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.249||0.1352|TWO_SIDED|95.0|-0.87|0.12|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.87|0.1352
91575949|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.121||0.0056|TWO_SIDED|95.0|0.1|0.58|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.10|0.0056
91575950|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1537|TWO_SIDED|95.0|-0.06|0.4|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.06|0.1537
91575951|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.129||0.0142|TWO_SIDED|95.0|0.07|0.58|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.07|0.0142
91575952|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.126||0.0159|TWO_SIDED|95.0|0.06|0.56|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.56|0.06|0.0159
91575953|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.132||0.2255|TWO_SIDED|95.0|-0.1|0.42|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.10|0.2255
91575954|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1069|TWO_SIDED|95.0|-0.05|0.46|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.05|0.1069
91575955|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.4932|TWO_SIDED|95.0|-0.19|0.39|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.19|0.4932
91575956|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2634|TWO_SIDED|95.0|-0.12|0.43|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.12|0.2634
91575957|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.133||0.9284|TWO_SIDED|95.0|-0.25|0.28|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.25|0.9284
91575958|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9459|TWO_SIDED|95.0|-0.25|0.26|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.25|0.9459
91575959|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2908|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2908
91575960|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.146||0.6834|TWO_SIDED|95.0|-0.23|0.35|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.23|0.6834
91575961|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.142||0.3579|TWO_SIDED|95.0|-0.41|0.15|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.41|0.3579
91575962|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.138||0.827|TWO_SIDED|95.0|-0.3|0.24|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.30|0.8270
91575963|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5292|TWO_SIDED|95.0|-0.34|0.18|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.34|0.5292
91575964|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.127||0.879|TWO_SIDED|95.0|-0.23|0.27|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.23|0.8790
91575965|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.1347|TWO_SIDED|95.0|-0.46|0.06|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.46|0.1347
91575966|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.129||0.2874|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2874
91575967|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.0086|TWO_SIDED|95.0|-0.61|-0.09|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.61|0.0086
91575968|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.7864|TWO_SIDED|95.0|-0.29|0.22|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.29|0.7864
91575969|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4383|TWO_SIDED|95.0|-0.48|0.21|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.48|0.4383
91575970|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.167||0.8767|TWO_SIDED|95.0|-0.36|0.31|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.36|0.8767
91575971|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.153||0.0341|TWO_SIDED|95.0|-0.63|-0.03|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.63|0.0341
91575972|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.147||0.5629|TWO_SIDED|95.0|-0.38|0.21|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.38|0.5629
91575973|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.129||0.0016|TWO_SIDED|95.0|-0.67|-0.16|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.16|-0.67|0.0016
91575974|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0495|TWO_SIDED|95.0|-0.5|0.0|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.50|0.0495
91575975|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.155||0.7177|TWO_SIDED|95.0|-0.36|0.25|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.36|0.7177
91575976|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.151||0.9401|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9401
91575977|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.3201|TWO_SIDED|95.0|-0.44|0.15|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.44|0.3201
91575978|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.144||0.8286|TWO_SIDED|95.0|-0.25|0.32|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.25|0.8286
91575979|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.162||0.3022|TWO_SIDED|95.0|-0.49|0.15|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.49|0.3022
91575980|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.158||0.8022|TWO_SIDED|95.0|-0.35|0.27|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.35|0.8022
91575981|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.165||0.5665|TWO_SIDED|95.0|-0.42|0.23|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.42|0.5665
91575982|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.161||0.817|TWO_SIDED|95.0|-0.36|0.28|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.36|0.8170
91575983|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.155||0.0404|TWO_SIDED|95.0|-0.63|-0.01|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.63|0.0404
91575984|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3128|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3128
91575985|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.162||0.24|TWO_SIDED|95.0|-0.51|0.13|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.51|0.2400
91575986|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.157||0.484|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4840
91575987|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.141||0.7768|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.32|0.7768
91575988|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7713|TWO_SIDED|95.0|-0.31|0.23|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.31|0.7713
91575989|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.151||0.0716|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0716
91575990|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.148||0.4317|TWO_SIDED|95.0|-0.41|0.18|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.41|0.4317
91575991|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2115|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.52|0.2115
91575992|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.158||0.2818|TWO_SIDED|95.0|-0.48|0.14|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.48|0.2818
91575993|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2018|TWO_SIDED|95.0|-0.46|0.1|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.46|0.2018
91575994|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.137||0.6554|TWO_SIDED|95.0|-0.33|0.21|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.33|0.6554
91575995|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.168||0.4754|TWO_SIDED|95.0|-0.21|0.46|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.21|0.4754
91575996|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.163||0.7776|TWO_SIDED|95.0|-0.28|0.37|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.28|0.7776
91575997|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.213||0.7172|TWO_SIDED|95.0|-0.5|0.35|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.50|0.7172
91575998|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.203||0.4791|TWO_SIDED|95.0|-0.55|0.26|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.55|0.4791
91575999|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.164||0.3562|TWO_SIDED|95.0|-0.48|0.17|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.48|0.3562
91576000|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.162||0.8859|TWO_SIDED|95.0|-0.3|0.34|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.30|0.8859
91576001|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.192||0.5888|TWO_SIDED|95.0|-0.49|0.28|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.49|0.5888
91576002|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3992|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3992
91576003|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.227||0.1212|TWO_SIDED|95.0|-0.8|0.1|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.80|0.1212
91576004|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.221||0.3185|TWO_SIDED|95.0|-0.66|0.22|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.66|0.3185
91576005|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.231||0.4809|TWO_SIDED|95.0|-0.62|0.29|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.62|0.4809
91576006|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.8953|TWO_SIDED|95.0|-0.42|0.48|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.48|-0.42|0.8953
91576007|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.223||0.5616|TWO_SIDED|95.0|-0.57|0.31|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.57|0.5616
91576008|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.216||0.8571|TWO_SIDED|95.0|-0.39|0.47|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.39|0.8571
91576009|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.213||0.0037|TWO_SIDED|95.0|-1.05|-0.21|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.05|0.0037
91576010|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.206||0.0386|TWO_SIDED|95.0|-0.84|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.84|0.0386
91576011|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0044|TWO_SIDED|95.0|-1.05|-0.2|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.05|0.0044
91576012|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.208||0.8308|TWO_SIDED|95.0|-0.46|0.37|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.46|0.8308
91576013|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0388|TWO_SIDED|95.0|-0.87|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.87|0.0388
91576014|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.209||0.1622|TWO_SIDED|95.0|-0.71|0.12|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.71|0.1622
91576015|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.204||0.0179|TWO_SIDED|95.0|-0.89|-0.09|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.89|0.0179
91576016|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.198||0.4283|TWO_SIDED|95.0|-0.55|0.24|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.55|0.4283
91576017|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.1899|TWO_SIDED|95.0|-0.72|0.15|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.72|0.1899
91576018|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.213||0.8022|TWO_SIDED|95.0|-0.48|0.37|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.48|0.8022
91576019|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.215||0.378|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3780
91576020|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.21||0.811|TWO_SIDED|95.0|-0.47|0.36|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.47|0.8110
91576021|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.272||0.8908|TWO_SIDED|95.0|-0.58|0.5|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.58|0.8908
91576022|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.263||0.3596|TWO_SIDED|95.0|-0.28|0.76|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.28|0.3596
91576023|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.293||0.7617|TWO_SIDED|95.0|-0.67|0.49|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.67|0.7617
91576024|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.281||0.5498|TWO_SIDED|95.0|-0.73|0.39|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.73|0.5498
91576025|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.235||0.2066|TWO_SIDED|95.0|-0.76|0.17|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.76|0.2066
91576026|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2321|TWO_SIDED|95.0|-0.73|0.18|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.73|0.2321
91576027|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.191||0.5582|TWO_SIDED|95.0|-0.49|0.27|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.49|0.5582
91576028|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.186||0.2945|TWO_SIDED|95.0|-0.56|0.17|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.56|0.2945
91576029|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.208||0.2684|TWO_SIDED|95.0|-0.64|0.18|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.64|0.2684
91576030|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.202||0.9396|TWO_SIDED|95.0|-0.42|0.39|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.42|0.9396
91576031|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.195||0.0283|TWO_SIDED|95.0|-0.82|-0.05|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.82|0.0283
91576032|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.189||0.1794|TWO_SIDED|95.0|-0.63|0.12|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.63|0.1794
91576033|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.188||0.1091|TWO_SIDED|95.0|-0.68|0.07|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.68|0.1091
91576034|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.182||0.7921|TWO_SIDED|95.0|-0.41|0.31|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.41|0.7921
91576035|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.166||0.0055|TWO_SIDED|95.0|-0.8|-0.14|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.80|0.0055
91576036|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.161||0.03|TWO_SIDED|95.0|-0.67|-0.03|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.67|0.0300
91576037|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.185||0.0118|TWO_SIDED|95.0|-0.84|-0.11|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.84|0.0118
91576038|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.178||0.2266|TWO_SIDED|95.0|-0.57|0.14|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.57|0.2266
91576039|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.0025|TWO_SIDED|95.0|-0.92|-0.2|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-0.92|0.0025
91576040|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.176||0.0555|TWO_SIDED|95.0|-0.69|0.01|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.69|0.0555
91576041|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.176||0.0013|TWO_SIDED|95.0|-0.93|-0.23|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-0.93|0.0013
91576042|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.171||0.0775|TWO_SIDED|95.0|-0.64|0.03|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.64|0.0775
91576043|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.19||0.0006|TWO_SIDED|95.0|-1.05|-0.3|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.30|-1.05|0.0006
91576044|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0415|TWO_SIDED|95.0|-0.75|-0.01|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.75|0.0415
91576045|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0581|TWO_SIDED|95.0|-0.75|0.01|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.75|0.0581
91576046|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.188||0.6826|TWO_SIDED|95.0|-0.45|0.3|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.45|0.6826
91576047|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.226||0.0912|TWO_SIDED|95.0|-0.83|0.06|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.83|0.0912
91576048|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3988|TWO_SIDED|95.0|-0.62|0.25|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.62|0.3988
91576049|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.231||0.0504|TWO_SIDED|95.0|-0.91|0.0|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.91|0.0504
91576050|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.22||0.6019|TWO_SIDED|95.0|-0.55|0.32|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.55|0.6019
91576051|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.222||0.007|TWO_SIDED|95.0|-1.05|-0.17|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.05|0.0070
91576052|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3785|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3785
91576053|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.9609|TWO_SIDED|95.0|-0.32|0.31|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.32|0.9609
91576054|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.154||0.9183|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9183
91576055|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.149||0.071|TWO_SIDED|95.0|-0.57|0.02|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.57|0.0710
91576056|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.2607|TWO_SIDED|95.0|-0.45|0.12|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.45|0.2607
91576057|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.158||0.2466|TWO_SIDED|95.0|-0.5|0.13|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.50|0.2466
91576058|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.153||0.3461|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3461
91576059|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0919|TWO_SIDED|95.0|-0.6|0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.60|0.0919
91576060|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.157||0.7554|TWO_SIDED|95.0|-0.36|0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.36|0.7554
91576061|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.166||0.015|TWO_SIDED|95.0|-0.74|-0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.74|0.0150
91576062|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.16||0.0482|TWO_SIDED|95.0|-0.64|0.0|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.64|0.0482
91576063|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.163||0.0003|TWO_SIDED|95.0|-0.93|-0.28|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.28|-0.93|0.0003
91576064|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.156||0.1182|TWO_SIDED|95.0|-0.56|0.06|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.56|0.1182
91576065|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.159||0.0008|TWO_SIDED|95.0|-0.87|-0.24|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.24|-0.87|0.0008
91576066|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.154||0.1379|TWO_SIDED|95.0|-0.54|0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.54|0.1379
91576067|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.145||0.004|TWO_SIDED|95.0|-0.71|-0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.71|0.0040
91576068|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.14||0.31|TWO_SIDED|95.0|-0.42|0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.42|0.3100
91576069|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.148||0.0003|TWO_SIDED|95.0|-0.85|-0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-0.85|0.0003
91576070|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.143||0.0223|TWO_SIDED|95.0|-0.61|-0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.61|0.0223
91576071|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.166||0.0276|TWO_SIDED|95.0|-0.7|-0.04|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.70|0.0276
91576072|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.161||0.8516|TWO_SIDED|95.0|-0.35|0.29|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.35|0.8516
91576073|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.186||0.1669|TWO_SIDED|95.0|-0.63|0.11|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.63|0.1669
91576074|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4935|TWO_SIDED|95.0|-0.48|0.23|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.48|0.4935
91576075|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.197||0.0202|TWO_SIDED|95.0|-0.86|-0.07|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.86|0.0202
91576076|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.188||0.2683|TWO_SIDED|95.0|-0.58|0.16|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.58|0.2683
91576077|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165||0.0531|TWO_SIDED|95.0|-0.65|0.0|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.65|0.0531
91576078|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5609|TWO_SIDED|95.0|-0.41|0.22|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.41|0.5609
91576079|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.123||0.6779|TWO_SIDED|95.0|-0.3|0.19|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.30|0.6779
91576080|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.119||0.4559|TWO_SIDED|95.0|-0.15|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.15|0.4559
91576081|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.133||0.2254|TWO_SIDED|95.0|-0.43|0.1|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.43|0.2254
91576082|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.129||0.6437|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6437
91576083|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.133||0.6678|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6678
91576084|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9321|TWO_SIDED|95.0|-0.27|0.24|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.27|0.9321
91576085|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.157||0.9778|TWO_SIDED|95.0|-0.31|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.31|0.9778
91576086|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.152||0.9307|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9307
91576087|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.172||0.6791|TWO_SIDED|95.0|-0.41|0.27|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.41|0.6791
91576088|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.167||0.7769|TWO_SIDED|95.0|-0.28|0.38|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.28|0.7769
91576089|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.163||0.7206|TWO_SIDED|95.0|-0.38|0.26|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.38|0.7206
91576090|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.156||0.3549|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3549
91576091|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.164||0.0231|TWO_SIDED|95.0|-0.7|-0.05|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.70|0.0231
91576092|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.159||0.145|TWO_SIDED|95.0|-0.55|0.08|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.55|0.1450
91576093|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0855|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0855
91576094|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.157||0.3068|TWO_SIDED|95.0|-0.47|0.15|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.47|0.3068
91576095|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.164||0.0069|TWO_SIDED|95.0|-0.77|-0.13|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.77|0.0069
91576096|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.159||0.2174|TWO_SIDED|95.0|-0.51|0.12|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.51|0.2174
91576097|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.174||0.102|TWO_SIDED|95.0|-0.63|0.06|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.63|0.1020
91576098|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9587|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9587
91576099|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.203||0.169|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1690
91576100|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.197||0.7919|TWO_SIDED|95.0|-0.34|0.44|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.34|0.7919
91576101|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.205||0.0192|TWO_SIDED|95.0|-0.89|-0.08|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.89|0.0192
91576102|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.196||0.3887|TWO_SIDED|95.0|-0.56|0.22|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.56|0.3887
91576103|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0719|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0719
91576104|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.185||0.1195|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1195
91576105|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.079||0.9552|TWO_SIDED|95.0|-0.16|0.15|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.16|0.9552
91576106|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.076||0.0384|TWO_SIDED|95.0|-0.31|-0.01|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.31|0.0384
91576107|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.2582|TWO_SIDED|95.0|-0.3|0.08|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.30|0.2582
91576108|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.094||0.1511|TWO_SIDED|95.0|-0.32|0.05|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.32|0.1511
91576109|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126||0.4631|TWO_SIDED|95.0|-0.34|0.16|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.34|0.4631
91576110|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.123||0.4628|TWO_SIDED|95.0|-0.33|0.15|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.33|0.4628
91576111|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9005|TWO_SIDED|95.0|-0.23|0.2|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.23|0.9005
91576112|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.107||0.1121|TWO_SIDED|95.0|-0.38|0.04|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.38|0.1121
91576113|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.4167|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4167
91576114|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4071|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4071
91576115|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1278|TWO_SIDED|95.0|-0.53|0.07|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.53|0.1278
91576116|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.145||0.0573|TWO_SIDED|95.0|-0.57|0.01|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.57|0.0573
91576117|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.156||0.4842|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4842
91576118|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.152||0.0692|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0692
91576119|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.157||0.4028|TWO_SIDED|95.0|-0.44|0.18|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.44|0.4028
91576120|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.154||0.0354|TWO_SIDED|95.0|-0.63|-0.02|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.63|0.0354
91576121|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.156||0.1228|TWO_SIDED|95.0|-0.55|0.07|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.55|0.1228
91576122|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.152||0.0099|TWO_SIDED|95.0|-0.7|-0.1|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.70|0.0099
91576123|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.2174|TWO_SIDED|95.0|-0.53|0.12|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.53|0.2174
91576124|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.161||0.082|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0820
91576125|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.194||0.2642|TWO_SIDED|95.0|-0.6|0.17|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.60|0.2642
91576126|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0718|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0718
91576127|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.212||0.3055|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3055
91576128|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.202||0.3533|TWO_SIDED|95.0|-0.59|0.21|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.59|0.3533
91576129|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.193||0.4514|TWO_SIDED|95.0|-0.53|0.24|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.53|0.4514
91576130|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.191||0.4907|TWO_SIDED|95.0|-0.51|0.25|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.51|0.4907
91576131|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.6949|TWO_SIDED|95.0|-0.36|0.24|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.36|0.6949
91576132|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.147||0.467|TWO_SIDED|95.0|-0.4|0.18|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.40|0.4670
91576133|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6556|TWO_SIDED|95.0|-0.39|0.25|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.39|0.6556
91576134|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9272|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9272
91576135|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.164||0.1395|TWO_SIDED|95.0|-0.57|0.08|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.57|0.1395
91576136|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.159||0.2601|TWO_SIDED|95.0|-0.5|0.14|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.50|0.2601
91576137|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.158||0.5626|TWO_SIDED|95.0|-0.4|0.22|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.40|0.5626
91576138|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4622|TWO_SIDED|95.0|-0.42|0.19|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.42|0.4622
91576139|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2858|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2858
91576140|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.146||0.5369|TWO_SIDED|95.0|-0.38|0.2|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.38|0.5369
91576141|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.151|TWO_SIDED|95.0|-0.52|0.08|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.52|0.1510
91576142|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.146||0.5107|TWO_SIDED|95.0|-0.38|0.19|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.38|0.5107
91576143|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3301|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3301
91576144|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5139|TWO_SIDED|95.0|-0.39|0.19|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.39|0.5139
91576145|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.144||0.4073|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4073
91576146|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4649|TWO_SIDED|95.0|-0.38|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.38|0.4649
91576147|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.141||0.6926|TWO_SIDED|95.0|-0.34|0.22|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.34|0.6926
91576148|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.137||0.726|TWO_SIDED|95.0|-0.22|0.32|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.22|0.7260
91576149|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.1486|TWO_SIDED|95.0|-0.47|0.07|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.47|0.1486
91576150|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.133||0.48|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.36|0.4800
91576151|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.177||0.7792|TWO_SIDED|95.0|-0.4|0.3|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.40|0.7792
91576152|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.171||0.8644|TWO_SIDED|95.0|-0.31|0.37|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.31|0.8644
91576153|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.158||0.7994|TWO_SIDED|95.0|-0.27|0.35|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.27|0.7994
91576154|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.152||0.0811|TWO_SIDED|95.0|-0.03|0.57|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.57|-0.03|0.0811
91576155|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.144||0.6978|TWO_SIDED|95.0|-0.34|0.23|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.34|0.6978
91576156|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.9749|TWO_SIDED|95.0|-0.28|0.28|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.28|0.9749
91576157|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.081||0.3158|TWO_SIDED|95.0|-0.08|0.24|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.08|0.3158
91576158|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1901|TWO_SIDED|95.0|-0.05|0.26|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.05|0.1901
91576159|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.073||0.7229|TWO_SIDED|95.0|-0.12|0.17|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.12|0.7229
91576160|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.071||0.2715|TWO_SIDED|95.0|-0.06|0.22|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.06|0.2715
91576161|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.5421|TWO_SIDED|95.0|-0.12|0.22|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.12|0.5421
91576162|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.083||0.7215|TWO_SIDED|95.0|-0.14|0.19|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.14|0.7215
91576163|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.098||0.2246|TWO_SIDED|95.0|-0.07|0.31|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.07|0.2246
91576164|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.096||0.9671|TWO_SIDED|95.0|-0.19|0.19|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.19|0.9671
91576165|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.121||0.6527|TWO_SIDED|95.0|-0.29|0.19|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.29|0.6527
91576166|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1647|TWO_SIDED|95.0|-0.4|0.07|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.40|0.1647
91576167|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7093|TWO_SIDED|95.0|-0.18|0.26|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.18|0.7093
91576168|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.6333|TWO_SIDED|95.0|-0.26|0.16|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.26|0.6333
91576169|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.5238|TWO_SIDED|95.0|-0.31|0.16|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.31|0.5238
91576170|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.117||0.0782|TWO_SIDED|95.0|-0.44|0.02|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.44|0.0782
91576171|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.2346|TWO_SIDED|95.0|-0.44|0.11|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.44|0.2346
91576172|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.134||0.0631|TWO_SIDED|95.0|-0.52|0.01|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.52|0.0631
91576173|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.131||0.6274|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6274
91576174|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.128||0.3589|TWO_SIDED|95.0|-0.37|0.14|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.37|0.3589
91576175|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7604|TWO_SIDED|95.0|-0.43|0.31|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.43|0.7604
91576176|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.185||0.1106|TWO_SIDED|95.0|-0.66|0.07|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.66|0.1106
91576177|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.222||0.9776|TWO_SIDED|95.0|-0.43|0.45|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.43|0.9776
91576178|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3239|TWO_SIDED|95.0|-0.65|0.22|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.65|0.3239
91576179|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.238||0.6736|TWO_SIDED|95.0|-0.57|0.37|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.57|0.6736
91576180|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6136|TWO_SIDED|95.0|-0.58|0.34|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.58|0.6136
91576181|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.195||0.1141|TWO_SIDED|95.0|-0.7|0.08|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.70|0.1141
91576182|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.194||0.2185|TWO_SIDED|95.0|-0.62|0.14|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.62|0.2185
91576183|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.054||0.6191|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6191
91576184|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.6169|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6169
91576185|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9911|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9911
91576186|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.336|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3360
91576187|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9638|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9638
91576188|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.053||0.161|TWO_SIDED|95.0|-0.03|0.18|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.03|0.1610
91576189|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.054||0.5763|TWO_SIDED|95.0|-0.14|0.08|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.14|0.5763
91576190|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.053||0.0599|TWO_SIDED|95.0|0.0|0.2|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|0.00|0.0599
91576191|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3916|TWO_SIDED|95.0|-0.15|0.06|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.15|0.3916
91576192|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9602|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.10|0.9602
91576193|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.9676|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9676
91576194|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6397|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6397
91576195|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.34|TWO_SIDED|95.0|-0.05|0.16|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.05|0.3400
91576196|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.3472|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3472
91576197|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.916|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9160
91576198|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5948|TWO_SIDED|95.0|-0.13|0.08|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.13|0.5948
91576199|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3755|TWO_SIDED|95.0|-0.06|0.16|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.06|0.3755
91576200|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9752|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9752
91576201|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.9188|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9188
91576202|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6379|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6379
91576203|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.061||0.4967|TWO_SIDED|95.0|-0.16|0.08|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.16|0.4967
91576204|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.3492|TWO_SIDED|95.0|-0.17|0.06|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.17|0.3492
91576205|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.062||0.7136|TWO_SIDED|95.0|-0.1|0.14|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.10|0.7136
91576206|NCT02942004|183039821|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8163|TWO_SIDED|95.0|-0.1|0.13|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.10|0.8163
91576207|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.2825|TWO_SIDED|95.0|-0.17|0.05|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.17|0.2825
91576208|NCT02942004|183039821|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.054||0.1603|TWO_SIDED|95.0|-0.18|0.03|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.18|0.1603
91576209|NCT02942004|183039822|SUPERIORITY||LS mean difference|-6.85|STANDARD_ERROR_OF_MEAN|2.414||0.0054|TWO_SIDED|95.0|-11.64|-2.07|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.07|-11.64|0.0054
91576210|NCT02942004|183039822|SUPERIORITY||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|2.35||0.0763|TWO_SIDED|95.0|-8.86|0.45|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-8.86|0.0763
91576211|NCT02942004|183039822|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.673||0.1101|TWO_SIDED|95.0|-9.6|0.99|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.99|-9.60|0.1101
91576212|NCT02942004|183039822|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.618||0.6167|TWO_SIDED|95.0|-6.5|3.87|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.87|-6.50|0.6167
91576213|NCT02942004|183039822|SUPERIORITY||LS mean difference|-5.64|STANDARD_ERROR_OF_MEAN|2.777||0.0447|TWO_SIDED|95.0|-11.14|-0.14|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-11.14|0.0447
91576214|NCT02942004|183039822|SUPERIORITY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|2.726||0.1908|TWO_SIDED|95.0|-8.99|1.81|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.81|-8.99|0.1908
91576215|NCT02942004|183039823|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0131|TWO_SIDED|95.0|1.3|11.7|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.7|1.3|0.0131
91576216|NCT02942004|183039823|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0095|TWO_SIDED|95.0|1.4|11.6|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.6|1.4|0.0095
91576217|NCT02942004|183039823|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0323|TWO_SIDED|95.0|1.1|7.5|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.5|1.1|0.0323
91576218|NCT02942004|183039823|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0931|TWO_SIDED|95.0|0.9|5.3|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||5.3|0.9|0.0931
91576219|NCT02942004|183039823|SUPERIORITY||Odds Ratio (OR)|3.6||||0.0139|TWO_SIDED|95.0|1.3|10.0|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||10.0|1.3|0.0139
91576220|NCT02942004|183039823|SUPERIORITY||Odds Ratio (OR)|2.6||||0.046|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||6.9|1.0|0.0460
91576221|NCT02942004|183039824|SUPERIORITY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.454||0.4389|TWO_SIDED|95.0|-4.01|1.75|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.75|-4.01|0.4389
91576222|NCT02942004|183039824|SUPERIORITY||LS mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.427||0.4645|TWO_SIDED|95.0|-3.88|1.78|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.78|-3.88|0.4645
91576223|NCT02942004|183039824|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.356||0.0622|TWO_SIDED|95.0|-5.24|0.13|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-5.24|0.0622
91576224|NCT02942004|183039824|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|1.338||0.8495|TWO_SIDED|95.0|-2.4|2.91|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.91|-2.40|0.8495
91576225|NCT02942004|183039824|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.59||0.7063|TWO_SIDED|95.0|-3.75|2.55|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.55|-3.75|0.7063
91576226|NCT02942004|183039824|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|1.552||0.9434|TWO_SIDED|95.0|-3.19|2.97|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.97|-3.19|0.9434
91576227|NCT02942004|183039824|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|1.608||0.9701|TWO_SIDED|95.0|-3.25|3.13|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.13|-3.25|0.9701
91576228|NCT02942004|183039824|SUPERIORITY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.566||0.6307|TWO_SIDED|95.0|-3.86|2.35|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.35|-3.86|0.6307
91576229|NCT02942004|183039824|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|1.488||0.1767|TWO_SIDED|95.0|-4.97|0.93|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.93|-4.97|0.1767
91576230|NCT02942004|183039824|SUPERIORITY||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.468||0.3236|TWO_SIDED|95.0|-4.37|1.45|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.45|-4.37|0.3236
91576231|NCT01028677|183039889|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 1 sided|||Analysis of fear emotion||||.61
91576232|NCT01028677|183039890|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||Positive Symptoms||||0.008
91576233|NCT01028677|183039890|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Negative Symptoms||||0.002
91576234|NCT01028677|183039890|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||General Symptoms||||0.04
91576235|NCT01028677|183039890|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Positive Symptoms||||0.05
91576236|NCT01028677|183039890|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Negative Symptoms||||0.08
91576237|NCT01028677|183039890|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||General Symptoms||||0.025
91576238|NCT01028677|183039892|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.03
91576239|NCT01028677|183039894|SUPERIORITY_OR_OTHER|||||||0.784|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||IRI-total||||.784
91576240|NCT01028677|183039894|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||Distress analysis||||1.00
91576241|NCT01028677|183039894|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Perspective-Taking||||.03
91576242|NCT01028677|183039894|SUPERIORITY_OR_OTHER|||||||0.135|||||||t-test, 2 sided|||Emotional empathy analysis||||.135
91576243|NCT01028677|183039894|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED||||||t-test, 2 sided|||Fantasy Analysis||||.681
91576244|NCT01028677|183039894|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||Distress analysis||||1.00
91576245|NCT01016262|183039938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between MAX-002 and placebo during the DB phase with respect to the primary outcome measure was the single pre-specified primary analysis, and the null hypothesis was that the percentages were equal between the two groups.||||0.0047
91576246|NCT01016262|183039938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0346||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between Canasa® and placebo during the DB phase with respect to the primary outcome measure was a pre-specified tertiary analysis only.||||0.0346
91576247|NCT03738475|183039943|SUPERIORITY|||||||0.0056||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0056
91576248|NCT03738475|183039947|SUPERIORITY|||||||0.0799||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0799
91576249|NCT03738475|183039949|SUPERIORITY|||||||0.289||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.2890
91576250|NCT02224703|183039967|SUPERIORITY||Treatment Ratio|0.743||||0.0299|TWO_SIDED|95.0|0.568|0.971|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.971|0.568|0.0299
91576251|NCT02224703|183039967|SUPERIORITY||Treatment Ratio|0.702||||0.0095|TWO_SIDED|95.0|0.538|0.916|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.916|0.538|0.0095
91576252|NCT02224703|183039968|SUPERIORITY||Treatment Ratio|0.749||||0.0255|TWO_SIDED|95.0|0.581|0.965|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.965|0.581|0.0255
91576253|NCT02224703|183039968|SUPERIORITY||Treatment Ratio|0.62||||0.0003|TWO_SIDED|95.0|0.481|0.799|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.799|0.481|0.0003
91576254|NCT02224703|183039969|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0069|TWO_SIDED|95.0|1.32|5.7|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||5.70|1.32|0.0069
91576255|NCT02224703|183039969|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0332|TWO_SIDED|95.0|1.06|4.62|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||4.62|1.06|0.0332
91576256|NCT02224703|183039970|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0279|TWO_SIDED|95.0|1.08|3.78|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||3.78|1.08|0.0279
91576257|NCT02224703|183039970|SUPERIORITY||Odds Ratio (OR)|2.93||||0.0009|TWO_SIDED|95.0|1.56|5.53|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||5.53|1.56|0.0009
91576258|NCT01304498|183040005|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.11|0.85|<0.001
91576259|NCT01304498|183040005|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.29|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.29|0.91|<0.001
91576260|NCT03325777|183040013|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.29|=|0.014|TWO_SIDED|95.0|0.14|1.27||a priori threshold is p\<.05|Mixed Models Analysis|Generalized Linear Mixed Models||||1.27|.14|=.014
91576261|NCT03325777|183040014|SUPERIORITY||Mean Difference (Final Values)|172.0|STANDARD_ERROR_OF_MEAN|33.2|<|0.001|TWO_SIDED|95.0|106.0|238.0||a priori threshold for significance was p\<.05|Mixed Models Analysis|||||238|106|<.001
91576262|NCT03004404|183040017|OTHER||Slope|0.748|STANDARD_ERROR_OF_MEAN|0.0743|||TWO_SIDED|95.0|0.5959|0.9001|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.9001|0.5959|
91576263|NCT03004404|183040017|OTHER||Ratio T/R|118.71|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|94.57|149.03|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.||149.03|94.57|
91576264|NCT03004404|183040017|OTHER||Geometric mean ratio T1/R (%)|124.79|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|116.858|133.255|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|133.255|116.858|
91576265|NCT03004404|183040017|OTHER||Geometric mean ratio T2/R (%)|125.17|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|112.89|138.8|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|138.80|112.89|
91576266|NCT03004404|183040018|OTHER||Slope|0.7065|STANDARD_ERROR_OF_MEAN|0.0587|||TWO_SIDED|95.0|0.5863|0.8267|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1|In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.8267|0.5863|
91576267|NCT03004404|183040018|OTHER||Ratio T/R|151.22|STANDARD_ERROR_OF_MEAN|1.107|||TWO_SIDED|90.0|122.781|186.248|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.||186.248|122.781|
91576268|NCT03004404|183040018|OTHER||Geometric mean ratio T1/R (%)|293.21|STANDARD_ERROR_OF_MEAN|1.069|||TWO_SIDED|90.0|259.044|331.891|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|331.891|259.044|
91576269|NCT03004404|183040018|OTHER||Geometric mean ratio T2/R (%)|180.53|STANDARD_ERROR_OF_MEAN|1.059|||TWO_SIDED|90.0|162.369|200.732|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|200.732|162.369|
91576270|NCT01937975|183040019|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.87|1.09|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.09|0.87|
91576271|NCT01937975|183040019|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.58|1.25|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.25|0.58|
91576272|NCT01937975|183040019|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.83|||||TWO_SIDED|90.0|0.56|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.22|0.56|
91576273|NCT01937975|183040019|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.65|||||TWO_SIDED|90.0|1.09|2.49|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.49|1.09|
91576274|NCT01937975|183040020|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.81|1.19|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.19|0.81|
91576275|NCT01937975|183040020|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.54|1.16|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.16|0.54|
91576276|NCT01937975|183040020|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.78|||||TWO_SIDED|90.0|0.53|1.14|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.14|0.53|
91576277|NCT01937975|183040020|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.6|||||TWO_SIDED|90.0|1.06|2.42|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.42|1.06|
91576278|NCT01937975|183040021|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.75|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.22|0.75|
91576279|NCT01937975|183040021|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.57|1.48|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.48|0.57|
91576280|NCT01937975|183040021|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.54|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.42|0.54|
91576281|NCT01937975|183040021|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|0.99|2.77|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.77|0.99|
91576282|NCT01937975|183040024|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.92|1.15|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.15|0.92|
91576283|NCT01937975|183040024|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.8|1.73|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.73|0.80|
91576284|NCT01937975|183040024|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|0.82|1.78|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.78|0.82|
91576285|NCT01937975|183040024|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.4|0.92|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.92|0.40|
91576286|NCT01937975|183040025|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.63|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.42|0.63|
91576287|NCT01937975|183040025|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.39|0.94|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.94|0.39|
91576288|NCT01937975|183040026|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|1.08|1.21|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.21|1.08|
91576289|NCT01937975|183040026|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.65|1.14|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.14|0.65|
91576290|NCT01937975|183040026|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.75|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.30|0.75|
91576291|NCT01937975|183040026|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.86|||||TWO_SIDED|90.0|1.38|2.51|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.51|1.38|
91576292|NCT01937975|183040027|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.24|||||TWO_SIDED|90.0|1.17|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.32|1.17|
91576293|NCT01937975|183040027|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.56|1.06|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.06|0.56|
91576294|NCT01937975|183040027|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.69|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.32|0.69|
91576295|NCT01937975|183040027|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.07|||||TWO_SIDED|90.0|1.46|2.93|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.93|1.46|
91576296|NCT01937975|183040028|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.0|1.26|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.26|1.00|
91576297|NCT01937975|183040028|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.62|1.13|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.13|0.62|
91576298|NCT01937975|183040028|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.7|1.27|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.27|0.70|
91576299|NCT01937975|183040028|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.21|2.28|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.28|1.21|
91576300|NCT01937975|183040031|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.83|0.92|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||0.92|0.83|
91576301|NCT01937975|183040031|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.16|||||TWO_SIDED|90.0|0.88|1.53|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.53|0.88|
91576302|NCT01937975|183040031|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.77|1.34|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.34|0.77|
91576303|NCT01937975|183040031|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|90.0|0.4|0.72|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.72|0.40|
91576304|NCT01937975|183040032|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.7|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.30|0.70|
91576305|NCT01937975|183040032|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.45|0.89|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.89|0.45|
91576306|NCT01602510|183040047|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.438|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Treatment Group as covariate|||1.25|0.59|=0.438
91576307|NCT01602510|183040047|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.212|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Site as covariate|||1.25|0.59|=0.212
91576308|NCT01602510|183040047|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.724|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.25|0.59|=0.724
91576309|NCT01602510|183040048|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.869|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Treatment Group as covariate|||1.66|0.55|=0.869
91576310|NCT01602510|183040048|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.061|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Site as covariate|||1.66|0.55|=0.061
91576311|NCT01602510|183040048|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.505|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.66|0.55|=0.505
91576312|NCT01602510|183040049|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.369|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Treatment Group as covariate|||1.32|0.48|=0.369
91576313|NCT01602510|183040049|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.955|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Site as covariate|||1.32|0.48|=0.955
91576314|NCT01602510|183040049|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.874|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.32|0.48|=0.874
91576315|NCT01602510|183040050|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.927|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Treatment Group as covariate|||1.40|0.73|=0.927
91576316|NCT01602510|183040050|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.036|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Site as covariate|||1.40|0.73|=0.036
91576317|NCT01602510|183040050|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.509|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.40|0.73|=0.509
91576318|NCT01602510|183040051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||=|0.833|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||||0.5|-0.4|=0.833
91576319|NCT01602510|183040052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||=|0.245|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.245
91576320|NCT01602510|183040053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.155|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|=0.155
91576321|NCT01602510|183040054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.661|TWO_SIDED|95.0|-1.4|2.2|||ANCOVA|||||2.2|-1.4|= 0.661
91576322|NCT01602510|183040055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.945|TWO_SIDED|95.0|-3.7|3.5|||ANCOVA|||||3.5|-3.7|= 0.945
91576323|NCT01602510|183040056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||=|0.047|TWO_SIDED|95.0|-1.66|-0.01|||ANCOVA|||||-0.01|-1.66|=0.047
91576324|NCT01721954|183040058|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.43|TWO_SIDED|95.0|||||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.||||0.43
91576325|NCT01721954|183040059|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED||||||Log Rank|||A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||<0.05
91576326|NCT02278484|183040064|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91576327|NCT01346072|183040072|SUPERIORITY|||||||0.853|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.853
91576328|NCT01346072|183040073|SUPERIORITY|||||||0.035|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.035
91576329|NCT01711853|183040085|SUPERIORITY_OR_OTHER|||||||0.5186|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.5186
91576330|NCT01711853|183040085|SUPERIORITY_OR_OTHER|||||||0.9883|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9883
91576331|NCT01711853|183040085|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.7853
91576332|NCT01711853|183040086|SUPERIORITY_OR_OTHER|||||||0.4692|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.4692
91576333|NCT01711853|183040086|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9734
91576334|NCT01711853|183040086|SUPERIORITY_OR_OTHER|||||||0.9201|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.9201
91576335|NCT00630734|183040121|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Threshold of significance was P\<0.05.|ANOVA|||Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).||||0.43
91576336|NCT00630734|183040122|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
91576337|NCT00630734|183040123|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
91576338|NCT00630734|183040124|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
91576339|NCT00630734|183040125|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
91576340|NCT00630734|183040126|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
91576341|NCT00630734|183040127|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
91576342|NCT00630734|183040128|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
91576343|NCT00630734|183040129|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||||||0.006
91576344|NCT00630734|183040130|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
91576345|NCT01040169|183040182|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91576346|NCT01040169|183040183|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
91576347|NCT04535544|183040229|SUPERIORITY||Difference of percentage|23.7||||0.011|TWO_SIDED|95.0|3.52|43.96|||Mantel-Haenszel|||Stratum-adjusted Mantel-Haenszel (MH) test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||43.96|3.52|0.011
91576348|NCT04535544|183040230|SUPERIORITY||Difference of percentage|26.8||||0.003|TWO_SIDED|95.0|7.38|46.21|||Mantel-Haenszel|||Stratum-adjusted MH test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||46.21|7.38|0.003
91576349|NCT01182441|183040240|SUPERIORITY|Success for this endpoint was achieved if the probability of experiencing an event was statistically less than the performance goal, defined as 2.67%, with an upper bound of the one-sided 95% credible interval less than the performance goal.|probability of experiencing an event|2.2|||||ONE_SIDED|95.0||2.652||||||Bayesian calculations were used to incorporate the data from PROTECT AF CAP Registry through a conjugate beta-binomial model. A one-sided upper 95% credible interval for the event rate was calculated based off this posterior distribution.||2.652||
91576350|NCT01182441|183040241|NON_INFERIORITY|This endpoint is met if the 95% Credible Interval for the rate ratio of WATCHMAN versus Warfarin is entirely less than 1.75.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.57|1.89||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval model were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately by treatment group and event type. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||1.89|0.57|
91576351|NCT01182441|183040242|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Difference (RD)|0.0053|||||TWO_SIDED|95.0|-0.019|0.0273||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||0.0273|-0.0190|
91576352|NCT01182441|183040242|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Ratio (RR)|1.6|||||TWO_SIDED|95.0|0.5|4.2||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||4.2|0.5|
91576353|NCT03317990|183040296|SUPERIORITY||Mean Difference (Final Values)|3.18|||<|0.0001|TWO_SIDED|95.0|1.62|4.75|||Regression, Linear|||Normal linear regression model adjusted for recruitment site, participant's age, and IIEF-5 at baseline, in participants with available data||4.75|1.62|<0.0001
91576354|NCT03317990|183040297|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Regression, Linear|||||-0.41|-2.42|0.006
91576355|NCT05332912|183040348|SUPERIORITY||||||=|0.066|||||||t-test, 1 sided|df = 26||Null Hypothesis: Participants with Down Syndrome will exhibit no change in number of correct items in Mental Rotation performance following 8 weeks of experiential training.||||=.066
91576356|NCT05332912|183040348|SUPERIORITY||||||=|0.056|||||||t-test, 1 sided|||Null Hypothesis: Amount of change in Mental Rotation performance following 8 weeks of experiential training will not differ for participants with Down Syndrome who received 8 weeks of experiential intervention and Typically Developing Children in the Delayed Intervention who had not received 8 weeks of intervention.||||=.056
91576357|NCT05332912|183040348|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|df = 55||Null Hypothesis: Amount of change in Mental Rotation performance following 8 weeks of experiential training will not differ for Typically Developing Children Immediate Intervention and Down Syndrome Participants Immediate intervention.||||=.65
91576358|NCT05332912|183040349|SUPERIORITY||||||=|0.039|||||||t-test, 1 sided|||Null Hypothesis: Participants with Down Syndrome will exhibit no change in number of correct items in Mental Rotation performance following 16 weeks of experiential training.||||=.039
91576359|NCT05332912|183040349|SUPERIORITY||||||=|0.32|||||||t-test, 2 sided|df = 48||Null Hypothesis: Participants with Down Syndrome in the Immediate Intervention condition and received 16 weeks of experiential training in Mental Rotation will exhibit a similar change in performance as Typically Developing Children in the Delayed Intervention condition who received only 8 weeks of experiential training.||||= .32
91576360|NCT05332912|183040349|SUPERIORITY||||||=|0.73||||||df = 55|t-test, 2 sided|||Null Hypothesis: Amount of change in Mental Rotation performance following 16 weeks of experiential training will not differ for Typically Developing Children Immediate Intervention and Down Syndrome Participants Immediate intervention.||||=.73
91576361|NCT05332912|183040350|SUPERIORITY||||||=|0.023|||||||t-test, 1 sided|df = 26||Null Hypothesis: Participants with Down Syndrome will exhibit no change in Perspective Taking performance following 8 weeks of experiential training.||||=.023
91576362|NCT05332912|183040350|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|df = 48||Null Hypothesis: Amount of change in Perspective Taking performance following 8 weeks of experiential training will not differ for participants with Down Syndrome who received 8 weeks of experiential intervention and Typically Developing Children in the Delayed Intervention who had not received 8 weeks of intervention.||||.23
91576363|NCT05332912|183040350|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|df = 55||Null Hypothesis: Amount of change in Mental Rotation will not differ for participants with Down Syndrome in the Immediate Intervention Condition who received 8 weeks of experiential intervention and Typically Developing Children in the Immediate Intervention who also received 8 weeks of intervention.||||.42
91576364|NCT05332912|183040351|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|df = 26||Null Hypothesis: Participants with Down Syndrome will exhibit no change in Perspective Taking performance following 16 weeks of experiential training.||||=.01
91576365|NCT05332912|183040351|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|df = 48||Null Hypothesis: Amount of change in Perspective Taking will not differ for participants with Down Syndrome in the Immediate Intervention Condition who received16 weeks of experiential intervention and Typically Developing Children in the Delayed Intervention condition who received 8 weeks of intervention.||||=.28
91576366|NCT05332912|183040351|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|df = 55||Null Hypothesis: Amount of change in Perspective Taking will not differ for participants with Down Syndrome in the Immediate Intervention Condition who received16 weeks of experiential intervention and Typically Developing Children in the Immediate Intervention who also received 16 weeks of intervention.||||.23
91576367|NCT01174446|183040352|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence will be established if 90% C.I. of ratio is contained completely in the margins of equivalence of 0.8 to 1.25.|Ratio of Geometric Means|1.063|||||TWO_SIDED|90.0|1.03|1.09||||||||1.09|1.03|
91576368|NCT01174446|183040379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779||95.0|||||Paired t-test|||||||0.7790
91576369|NCT01174446|183040379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999||95.0|||||Paired t-test|||||||0.8999
91576370|NCT01174446|183040380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||Paired t-test|||||||0.0056
91576371|NCT01174446|183040380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413||95.0|||||Paired t-test|||||||0.4130
91576372|NCT01174446|183040381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9059||95.0|||||Paired t-test|||||||0.9059
91576373|NCT01174446|183040381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4098||95.0|||||Paired t-test|||||||0.4098
91576374|NCT01174446|183040382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0189||95.0|||||Paired t-test|||||||0.0189
91576375|NCT01174446|183040382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2974||95.0|||||Paired t-test|||||||0.2974
91576376|NCT01174446|183040383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2009||95.0|||||Paired t-test|||||||0.2009
91576377|NCT01174446|183040383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3552||95.0|||||Paired t-test|||||||0.3552
91576378|NCT01174446|183040384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5143||95.0|||||Paired t-test|||||||0.5143
91576379|NCT01174446|183040384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9223||95.0|||||Paired t-test|||||||0.9223
91576380|NCT01174446|183040385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0162||95.0|||||Paired t-test|||||||0.0162
91576381|NCT01174446|183040385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3176||95.0|||||Paired t-test|||||||0.3176
91576382|NCT01174446|183040386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.821||95.0|||||Paired t-test|||||||0.8210
91576383|NCT01174446|183040386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5565||95.0|||||Paired t-test|||||||0.5565
91576384|NCT01174446|183040387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||Paired t-test|||||||0.0146
91576385|NCT01174446|183040387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4048||95.0|||||Paired t-test|||||||0.4048
91576386|NCT01174446|183040388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1258||95.0|||||Paired t-test|||||||0.1258
91576387|NCT01174446|183040388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2567||95.0|||||Paired t-test|||||||0.2567
91576388|NCT01174446|183040389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1048||95.0|||||Paired t-test|||||||0.1048
91576389|NCT01174446|183040389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||95.0|||||Paired t-test|||||||0.6410
91576390|NCT01174446|183040390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||95.0|||||Paired t-test|||||||0.0663
91576391|NCT01174446|183040390|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0|||||Paired t-test|||||||0.4890
91576392|NCT01174446|183040391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0562||95.0|||||Paired t-test|||||||0.0562
91576393|NCT01174446|183040391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3864||95.0|||||Paired t-test|||||||0.3864
91576394|NCT01174446|183040392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5792||95.0|||||Paired t-test|||||||0.5792
91576395|NCT01174446|183040393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4208||95.0|||||Paired t-test|||||||0.4208
91576396|NCT01174446|183040394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Paired t-test|||||||0.5000
91576397|NCT01174446|183040395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633||95.0|||||Paired t-test|||||||0.0633
91576398|NCT01174446|183040395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363||95.0|||||Paired t-test|||||||0.9363
91576399|NCT03301155|183040402|SUPERIORITY|||||||0.001|||||||Regression, Logistic|Comparison performed on the regression parameters scale. Estimates for mean time obtained under assumption of exponentially distributed time-to-event.||||||0.001
91576400|NCT03301155|183040402|SUPERIORITY|superiority margin for hazard ratio was prespecified as 0.846. Lower hazard is better thus the upper confidence limit of HR expected to be lesser than margin|Hazard Ratio (HR)|0.645||||0.0218|TWO_SIDED|95.0|0.496|0.839|||Regression, Cox||Lower HR is better|||0.839|0.496|0.0218
91576401|NCT03301155|183040403|SUPERIORITY|||||||0.0003||||||Adjusted with Holm method for multiple comparrisons|Fisher Exact|||Comparison between groups on week 4||||0.0003
91576402|NCT03301155|183040403|SUPERIORITY|Adjusted with Holm method for multiple comparrisons||||||0.0003|||||||Fisher Exact|||Comparison between groups on week 8||||0.0003
91576403|NCT03301155|183040403|SUPERIORITY|||||||0.0021|||||||Fisher Exact|||Comparison between groups on week 12||||0.0021
91576404|NCT03301155|183040404|SUPERIORITY|||||||0.1372|||||||Fisher Exact|||||||0.1372
91576405|NCT03301155|183040405|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91576406|NCT03301155|183040406|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
91576407|NCT00384189|183040427|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.3||0.0116|TWO_SIDED|95.0|1.4|18.3|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||18.3|1.4|0.0116
91576408|NCT00384189|183040427|SUPERIORITY_OR_OTHER||Least Square Means Difference|9.4|STANDARD_ERROR_OF_MEAN|4.3||0.0148|TWO_SIDED|95.0|0.9|17.8|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||17.8|0.9|0.0148
91576409|NCT00384189|183040427|SUPERIORITY_OR_OTHER||Least Squares Means Difference|12.0|STANDARD_ERROR_OF_MEAN|4.3||0.0028|TWO_SIDED|95.0|3.5|20.4|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||20.4|3.5|0.0028
91576410|NCT00384189|183040428|SUPERIORITY_OR_OTHER|||||||0.1362||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1362
91576411|NCT00384189|183040428|SUPERIORITY_OR_OTHER|||||||0.0891||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.0891
91576412|NCT00384189|183040428|SUPERIORITY_OR_OTHER|||||||0.1574||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1574
91576413|NCT00384189|183040429|SUPERIORITY_OR_OTHER|||||||0.001||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0010
91576414|NCT00384189|183040429|SUPERIORITY_OR_OTHER|||||||0.0006||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0006
91576415|NCT00384189|183040429|SUPERIORITY_OR_OTHER|||||||0.0002||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0002
91576416|NCT01370655|183040455|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is~≤0 mmHg"|Difference in Least square (LS) means|-7.4|||||TWO_SIDED|80.0|-10.6|-4.1|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||-4.1|-10.6|
91576417|NCT01370655|183040455|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the upper bound of the two-sided 90% CI (equivalent to a one-sided upper 95% CI) for the difference ≤ 3.8 mmHg.|Difference in LS means|-5.4|||||TWO_SIDED|90.0|-9.2|-1.6|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|Type I error rate of alpha=0.05 (1-sided) is specified for testing of the hypothesis.||-1.6|-9.2|
91576418|NCT01370655|183040455|SUPERIORITY_OR_OTHER||Difference in LS means|-4.8|||||TWO_SIDED|90.0|-9.0|-0.5|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.5|-9.0|
91576419|NCT01370655|183040455|SUPERIORITY_OR_OTHER||Difference in LS Means|-6.7|||||TWO_SIDED|90.0|-11.2|-2.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-2.2|-11.2|
91576420|NCT01370655|183040455|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9|||||TWO_SIDED|90.0|-6.2|2.3|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.3|-6.2|
91576421|NCT01370655|183040456|SUPERIORITY_OR_OTHER||Difference in LS means|-3.2|||||TWO_SIDED|90.0|-6.1|-0.3|||||MK-7145 6 mg LS mean minus Placebo LS mean|||-0.3|-6.1|
91576422|NCT01370655|183040456|SUPERIORITY_OR_OTHER||Difference in LS means|-2.9|||||TWO_SIDED|90.0|-5.5|-0.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||-0.2|-5.5|
91576423|NCT01370655|183040456|SUPERIORITY_OR_OTHER||Difference in LS means|-3.0|||||TWO_SIDED|90.0|-6.0|-0.1|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.1|-6.0|
91576424|NCT01370655|183040456|SUPERIORITY_OR_OTHER||Difference in LS means|-3.4|||||TWO_SIDED|90.0|-6.5|-0.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-0.2|-6.5|
91576425|NCT01370655|183040456|SUPERIORITY_OR_OTHER||Difference in LS means|-0.3|||||TWO_SIDED|90.0|-3.3|2.7|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.7|-3.3|
91576426|NCT01370655|183040457|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the lower bound of the two-sided 80% CI (equivalent to a one-sided lower 90% CI) is \> 89.0 mmol/day.|Difference in LS means|76.5|||||TWO_SIDED|80.0|49.2|103.8|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||103.8|49.2|
91576427|NCT01370655|183040457|SUPERIORITY_OR_OTHER||Difference in LS means|-63.7|||||TWO_SIDED|90.0|-100.8|-26.7|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-26.7|-100.8|
91576428|NCT01370655|183040457|SUPERIORITY_OR_OTHER||Difference in LS means|-18.1|||||TWO_SIDED|90.0|-49.1|12.9|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||12.9|-49.1|
91576429|NCT01370655|183040457|SUPERIORITY_OR_OTHER||Difference in LS means|30.9|||||TWO_SIDED|90.0|-7.0|68.7|||||MK-7145 3 mg LS mean minus Placebo LS mean|||68.7|-7.0|
91576430|NCT01370655|183040457|SUPERIORITY_OR_OTHER||Difference in LS means|94.6|||||TWO_SIDED|90.0|58.8|130.4|||||HCTZ 25 mg LS mean minus Placebo LS mean|||130.4|58.8|
91576431|NCT01370655|183040461|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|7.9|||||TWO_SIDED|80.0|-2.3|18.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||18.2|-2.3|
91576432|NCT01370655|183040461|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|1.1|||||TWO_SIDED|80.0|-8.5|10.7|||||MK-7145 6 mg LS mean minus Placebo LS mean|||10.7|-8.5|
91576433|NCT01370655|183040461|SUPERIORITY_OR_OTHER||Difference in LS means|3.0|||||TWO_SIDED|90.0|-9.6|15.6|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||15.6|-9.6|
91576434|NCT01370655|183040461|SUPERIORITY_OR_OTHER||Difference in LS means|-3.9|||||TWO_SIDED|90.0|-15.0|7.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||7.2|-15.0|
91576435|NCT01370655|183040461|SUPERIORITY_OR_OTHER||Difference in LS means|5.0|||||TWO_SIDED|90.0|-7.7|17.6|||||HCTZ 25 mg LS mean minus Placebo LS mean|||17.6|-7.7|
91576436|NCT03119233|183040506|OTHER||Lower 97.5% Exact Confidence Limit|68.1|||||ONE_SIDED|97.5|60.9|||||||"The primary effectiveness endpoint is defined as primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR)~≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. The primary effectiveness endpoint hypotheses are:~* H0: 12-month success rate of the PQ Bypass System ≤60.4%~* HA: 12-month success rate of the PQ Bypass System \>60.4%"|||60.9|
91576437|NCT03119233|183040507|OTHER|The rate of freedom from 30-day MAE is expected to be no less than 92%. Based on a PG of 84% and an estimated 30-day freedom from MAE rate of 92% for the PQ Bypass System, a sample size of 169 evaluable subjects provides 88% power to test the primary safety hypothesis at the one-sided alpha level of 0.025. The Exact Test Method and Commercial software PASS14 was used to determine the sample size.|Lower 97.5% Exact Confidence Limit|93.0|||||ONE_SIDED|97.5|88.5|||||||"The primary safety endpoint hypotheses are:~* H0: 30-day Freedom from MAE rate of the PQ Bypass System~  ≤84%~* HA: 30-day Freedom from MAE rate of the PQ Bypass System \>84%"|||88.5|
91576438|NCT02057575|183040511|SUPERIORITY||||||<|0.0001||||||PG324 0.01% vs netarsudil|t-test, 2 sided|||||||<0.0001
91576439|NCT02057575|183040511|SUPERIORITY||||||<|0.0001||||||PG324 0.02% vs. netarsudil|t-test, 2 sided|||||||<0.0001
91576440|NCT02057575|183040511|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.01% vs. latanoprost||||||<0.0001
91576441|NCT02057575|183040511|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.02% vs. latanoprost||||||<0.0001
91576442|NCT01254552|183040517|OTHER||rate|0.071|||||TWO_SIDED|95.0|0.043|0.1||||||||0.100|0.043|
91576443|NCT02579135|183040550|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.32|TWO_SIDED||||||Regression, Linear|||Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||.32
91576444|NCT02579135|183040551|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|8.31|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED||||||Regression, Linear|||We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||<.001
91576445|NCT01146600|183040552|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|ANOVA, comparing baseline, clarithromycin, and placebo||||||0.47
91576446|NCT01146600|183040553|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.63
91576447|NCT01146600|183040554|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.64
91576448|NCT01146600|183040555|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
91576449|NCT01146600|183040556|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
91576450|NCT01146600|183040557|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.01
91576451|NCT01146600|183040558|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.76
91576452|NCT00659880|183040559|SUPERIORITY_OR_OTHER|||||||0.06|||||||Friedman|||||||0.06
91576453|NCT02964325|183040584|NON_INFERIORITY|An NI analysis was carried out to assess the primary efficacy endpoint with the null hypothesis being the MIRASOL group is inferior to the CONTROL group and the alternative hypothesis being the MIRASOL group is non-inferior to the CONTROL group. In this study, the NI margin was 1.6.|Relative Rate|2.79|||||TWO_SIDED|95.0|1.67|4.67|||||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative rate. For days during off-protocol intervals, bleeding data were simulated using an estimate of the individual-specific bleeding rate.|The MIRASOL and CONTROL groups were compared with respect to the number of days of WHO ≥ Grade 2 bleeding. This was carried out by fitting a negative binomial regression model with an offset defined as the natural logarithm (LN) of the number of days that bleeding was assessed in order to account for the fact that subjects had different numbers of bleeding assessment days.||4.67|1.67|
91576454|NCT02964325|183040586|NON_INFERIORITY|A non-inferiority margin of 1.2 was used to evaluated this endpoint.|Relative Risk|1.32||||0.7274|TWO_SIDED|95.0|0.97|1.81|||Wald Non-inferiority Test||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative risk.|The null hypothesis was H0: pt/pc \> 1.2 (ie, MIRASOL had more than a 20% higher probability of a patient experiencing at least one WHO ≥ Grade 2 bleed compared to CONTROL).||1.81|0.97|0.7274
91576455|NCT02964325|183040587|OTHER|||||||0.07|||||||Log-rank test|||||||0.07
91576456|NCT02964325|183040588|OTHER|||||||0.1649|||||||Fisher Exact|||||||0.1649
91576457|NCT02964325|183040589|OTHER||Risk Ratio (RR)|2.15||||0.0015|TWO_SIDED|95.0|1.32|3.49|||Fisher Exact|||||3.49|1.32|0.0015
91576458|NCT03596762|183040592|SUPERIORITY||Difference in LS means|-1.52|||=|0.1946|TWO_SIDED|95.0|-3.83|0.78|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.78|-3.83|= 0.1946
91576459|NCT03596762|183040592|SUPERIORITY||Difference in LS means|1.29|||=|0.3682|TWO_SIDED|95.0|-4.11|1.53|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||1.53|-4.11|= 0.3682
91576460|NCT03596762|183040592|SUPERIORITY||Difference in LS means|-3.93|||=|0.0002|TWO_SIDED|95.0|-5.94|-1.92|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-1.92|-5.94|= 0.0002
91576461|NCT03596762|183040592|SUPERIORITY||Difference in LS means|-2.63|||=|0.0115|TWO_SIDED|95.0|-4.66|-0.6|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-0.6|-4.66|= 0.0115
91576462|NCT03596762|183040593|SUPERIORITY||Difference in LS means|-1.67|||=|0.2097|TWO_SIDED|95.0|-4.28|-0.95|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.95|-4.28|= 0.2097
91576463|NCT03596762|183040593|SUPERIORITY||Difference in LS means|-0.77|||=|0.6369|TWO_SIDED|95.0|-3.97|2.44|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||2.44|-3.97|= 0.6369
91576464|NCT03596762|183040593|SUPERIORITY||Difference in LS means|-2.95|||=|0.0116|TWO_SIDED|95.0|-5.22|-0.67|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.67|-5.22|= 0.0116
91576465|NCT03596762|183040593|SUPERIORITY||Difference in LS means|-1.78|||=|0.1346|TWO_SIDED|95.0|-4.12|0.56|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.56|-4.12|= 0.1346
91576466|NCT03596762|183040594|SUPERIORITY||Difference in LS means|-0.05|||=|0.7033|TWO_SIDED|95.0|-0.3|0.2|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.2|-0.3|= 0.7033
91576467|NCT03596762|183040594|SUPERIORITY||Difference in LS means|-0.14|||=|0.3724|TWO_SIDED|95.0|-0.45|0.17|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.17|-0.45|= 0.3724
91576468|NCT03596762|183040594|SUPERIORITY||Difference in LS means|-0.19|||=|0.0896|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.0896
91576469|NCT03596762|183040594|SUPERIORITY||Difference in LS means|-0.19|||=|0.09|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.09
91576470|NCT03596762|183040595|SUPERIORITY||Difference in LS means|-0.09|||=|0.5511|TWO_SIDED|95.0|-0.39|0.21|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.21|-0.39|= 0.5511
91576471|NCT03596762|183040595|SUPERIORITY||Difference in LS means|0.16|||=|0.3822|TWO_SIDED|95.0|-0.2|0.52|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.52|-0.2|= 0.3822
91576472|NCT03596762|183040595|SUPERIORITY||Difference in LS means|-0.15|||=|0.2606|TWO_SIDED|95.0|-0.41|0.11|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.11|-0.41|= 0.2606
91576473|NCT03596762|183040595|SUPERIORITY||Difference in LS means|-0.27|||=|0.0479|TWO_SIDED|95.0|-0.53|0.0|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0|-0.53|= 0.0479
91576474|NCT01512797|183040714|OTHER|||||||0.028||||||P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.|t-test, 2 sided|||Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120' post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power \> 90%.||||0.028
91576475|NCT00895895|183040800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.424|TWO_SIDED|95.0|-1.0|2.3|||Mixed Models Analysis|Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(\*)visit visit treatment treatment\*visit.||Analysis of adjusted difference in change from baseline.||2.3|-1.0|0.424
91576476|NCT00895895|183040800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.849|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-1.8|0.849
91576477|NCT00895895|183040800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.2|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.2|0.520
91576478|NCT00895895|183040800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.258|TWO_SIDED|95.0|-2.6|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-2.6|0.258
91576479|NCT00895895|183040801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.367|TWO_SIDED|95.0|-5.2|1.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.9|-5.2|0.367
91576480|NCT00895895|183040801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.91|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.7|-3.3|0.910
91576481|NCT00895895|183040801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.16|TWO_SIDED|95.0|-1.0|6.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.0|-1.0|0.160
91576482|NCT00895895|183040801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.06|TWO_SIDED|95.0|-0.1|6.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.9|-0.1|0.060
91576483|NCT00895895|183040802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.931|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.1|-2.8|0.931
91576484|NCT00895895|183040802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.054|TWO_SIDED|95.0|-5.8|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-5.8|0.054
91576485|NCT00895895|183040802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.246|TWO_SIDED|95.0|-4.6|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.6|0.246
91576486|NCT00895895|183040802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.426|TWO_SIDED|95.0|-4.1|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-4.1|0.426
91576487|NCT00895895|183040803|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.265
91576488|NCT00895895|183040803|SUPERIORITY_OR_OTHER|||||||0.682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.682
91576489|NCT00895895|183040803|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.532
91576490|NCT00895895|183040803|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.087
91576491|NCT00895895|183040803|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.751
91576492|NCT00895895|183040804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.553|TWO_SIDED|95.0|-3.9|7.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.3|-3.9|0.553
91576493|NCT00895895|183040804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-6.0|5.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||5.2|-6.0|0.886
91576494|NCT00895895|183040804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.712|TWO_SIDED|95.0|-6.6|4.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||4.5|-6.6|0.712
91576495|NCT00895895|183040804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.785|TWO_SIDED|95.0|-4.8|6.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.4|-4.8|0.785
91576496|NCT00895895|183040805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-0.5|0.251
91576497|NCT00895895|183040805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-0.3|0.993
91576498|NCT00895895|183040805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.553|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.553
91576499|NCT00895895|183040805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.611
91576500|NCT00895895|183040806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-1.5|0.340
91576501|NCT00895895|183040806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.63|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.630
91576502|NCT00895895|183040806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.678|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.678
91576503|NCT00895895|183040806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.518|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.3|0.518
91576504|NCT00895895|183040807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.953|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-0.7|0.953
91576505|NCT00895895|183040807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.956|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.6|-0.7|0.956
91576506|NCT00895895|183040807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.216|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.1|0.216
91576507|NCT00895895|183040807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.665|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-0.8|0.665
91576508|NCT00895895|183040808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.373|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.6|0.373
91576509|NCT00895895|183040808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.781|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.3|-1.0|0.781
91576510|NCT00895895|183040808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.417|TWO_SIDED|95.0|-0.7|1.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.6|-0.7|0.417
91576511|NCT00895895|183040808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.853|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.0|-1.3|0.853
91576512|NCT00895895|183040809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.428|TWO_SIDED|95.0|-2.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.6|0.428
91576513|NCT00895895|183040809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.763|TWO_SIDED|95.0|-2.1|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-2.1|0.763
91576514|NCT00895895|183040809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.312|TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.9|-2.7|0.312
91576515|NCT00895895|183040809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.215|TWO_SIDED|95.0|-3.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-3.0|0.215
91576516|NCT00895895|183040810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.956|TWO_SIDED|95.0|-2.7|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.7|0.956
91576517|NCT00895895|183040810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.6|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.6|0.988
91576518|NCT00895895|183040810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.89|TWO_SIDED|95.0|-2.7|2.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.4|-2.7|0.890
91576519|NCT00895895|183040810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.28|TWO_SIDED|95.0|-4.0|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.0|0.280
91576520|NCT00895895|183040811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.154|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.5|0.154
91576521|NCT00895895|183040811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-1.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.0|0.740
91576522|NCT00895895|183040811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.179|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-1.4|0.179
91576523|NCT00895895|183040811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.543|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-0.6|0.543
91576524|NCT00895895|183040812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.4||||0.861|TWO_SIDED|95.0|-739.7|618.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||618.8|-739.7|0.861
91576525|NCT00895895|183040812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-926.6||||0.007|TWO_SIDED|95.0|-1596.9|-256.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-256.3|-1596.9|0.007
91576526|NCT00895895|183040812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.3||||0.676|TWO_SIDED|95.0|-522.1|804.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||804.6|-522.1|0.676
91576527|NCT00895895|183040812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|230.6||||0.505|TWO_SIDED|95.0|-449.7|910.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||910.9|-449.7|0.505
91576528|NCT00895895|183040813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.267|TWO_SIDED|95.0|-2.2|7.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.8|-2.2|0.267
91576529|NCT00895895|183040813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.145|TWO_SIDED|95.0|-1.3|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.3|0.145
91576530|NCT00895895|183040813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.139|TWO_SIDED|95.0|-1.2|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.2|0.139
91576531|NCT00895895|183040813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.386|TWO_SIDED|95.0|-2.8|7.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.2|-2.8|0.386
91576532|NCT00895895|183040814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-0.1|-2.3|0.032
91576533|NCT00895895|183040814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.264|TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.5|0.264
91576534|NCT00895895|183040814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.893|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-1.0|0.893
91576535|NCT00895895|183040814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.525|TWO_SIDED|95.0|-0.7|1.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.4|-0.7|0.525
91576536|NCT00895895|183040815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.9||||0.056|TWO_SIDED|95.0|-1.6|123.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||123.5|-1.6|0.056
91576537|NCT00895895|183040815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.8||||0.488|TWO_SIDED|95.0|-40.0|83.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||83.5|-40.0|0.488
91576538|NCT00895895|183040815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.783|TWO_SIDED|95.0|-52.6|69.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||69.8|-52.6|0.783
91576539|NCT00895895|183040815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.578|TWO_SIDED|95.0|-44.6|79.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||79.8|-44.6|0.578
91576540|NCT00895895|183040816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.175|TWO_SIDED|95.0|-13.9|76.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||76.1|-13.9|0.175
91576541|NCT00895895|183040816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.352|TWO_SIDED|95.0|-23.3|65.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.4|-23.3|0.352
91576542|NCT00895895|183040816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.797|TWO_SIDED|95.0|-38.1|49.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||49.6|-38.1|0.797
91576543|NCT00895895|183040816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.633|TWO_SIDED|95.0|-55.6|33.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||33.9|-55.6|0.633
91576544|NCT00895895|183040817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.2||||0.066|TWO_SIDED|95.0|-4.7|147.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||147.0|-4.7|0.066
91576545|NCT00895895|183040817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.598|TWO_SIDED|95.0|-54.6|94.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||94.7|-54.6|0.598
91576546|NCT00895895|183040817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.766|TWO_SIDED|95.0|-62.9|85.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.3|-62.9|0.766
91576547|NCT00895895|183040817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.8||||0.378|TWO_SIDED|95.0|-41.5|109.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||109.1|-41.5|0.378
91576548|NCT00895895|183040818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5||||0.481|TWO_SIDED|95.0|-40.2|85.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.2|-40.2|0.481
91576549|NCT00895895|183040818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.894|TWO_SIDED|95.0|-57.5|65.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.9|-57.5|0.894
91576550|NCT00895895|183040818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.991|TWO_SIDED|95.0|-61.5|60.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||60.8|-61.5|0.991
91576551|NCT00895895|183040818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5||||0.422|TWO_SIDED|95.0|-87.9|36.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||36.9|-87.9|0.422
91576552|NCT00895895|183040819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.581|TWO_SIDED|95.0|0.24|2.22|||Regression, Logistic|||||2.22|0.24|0.581
91576553|NCT00895895|183040819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.77|TWO_SIDED|95.0|0.42|3.19|||Regression, Logistic|||||3.19|0.42|0.770
91576554|NCT00895895|183040819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.216|TWO_SIDED|95.0|0.71|4.55|||Regression, Logistic|||||4.55|0.71|0.216
91576555|NCT00895895|183040819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.037|TWO_SIDED|95.0|1.06|6.42|||Regression, Logistic|||||6.42|1.06|0.037
91576556|NCT02514551|183040905|SUPERIORITY||Hazard Ratio (HR)|0.617|||||TWO_SIDED|95.0|0.447|0.853|||||Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)|"This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)"||0.853|0.447|
91576557|NCT02514551|183040906|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.727|1.274|||||Unstratified cox proportional hazards model.|||1.274|0.727|
91576558|NCT03197766|183041005|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analysis for the primary endpoint.|ANCOVA|Two subjects in the BMN 111 group discontinued from the study before Week 52. The values for these 2 subjects were imputed for this analysis.||||||< 0.0001
91576559|NCT03197766|183041006|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||< 0.0001
91576560|NCT03197766|183041007|SUPERIORITY||||||=|0.506||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||= 0.506
91576561|NCT00305344|183041009|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Fisher Exact|||Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion||||>0.05
91576562|NCT01123070|183041039|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.93||||0.4265|TWO_SIDED|90.0|0.797|1.084|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator and MabThera arm is the denominator|||1.084|0.797|0.4265
91576563|NCT01123070|183041040|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.862||||0.0368|TWO_SIDED|90.0|0.768|0.968|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|||0.968|0.768|0.0368
91576564|NCT01123070|183041042|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.909||||0.1484|TWO_SIDED|90.0|0.814|1.014|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax1||1.014|0.814|0.1484
91576565|NCT01123070|183041042|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.766||||0.0241|TWO_SIDED|90.0|0.633|0.927|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax2||0.927|0.633|0.0241
91576566|NCT01123070|183041043|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.969||||0.652|TWO_SIDED|90.0|0.863|1.088|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|AUC1||1.088|0.863|0.6520
91576567|NCT01123070|183041043|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.961||||0.7835|TWO_SIDED|90.0|0.757|1.222|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|AUC2||1.222|0.757|0.7835
91576568|NCT00918879|183041069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.139||0.0011||95.0|-0.73|-0.18|||ANCOVA|\* adjusted for baseline HbA1c||||-0.18|-0.73|0.0011
91576569|NCT00918879|183041070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|5.438||0.0623||95.0|-20.91|0.53|||ANCOVA|\* Adjusted for baseline FPG||||0.53|-20.91|0.0623
91576570|NCT00918879|183041071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.302||0.0623||95.0|-1.17|0.02|||ANCOVA|\* Adjusted for baseline FPG||||0.02|-1.17|0.0623
91576571|NCT00918879|183041072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||||95.0|-1.7|19.3|||Fisher Exact|||||19.3|-1.7|
91576572|NCT00384774|183041084|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Headache Response||||1.0000
91576573|NCT00384774|183041084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0991|||||||Fisher Exact|||Headache Response||||0.0991
91576574|NCT00384774|183041084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4851|||||||Chi-squared|||Headache Response||||0.4851
91576575|NCT00384774|183041084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1178|||||||Chi-squared|||Headache Response||||0.1178
91576576|NCT00384774|183041084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1093|||||||Chi-squared|||Headache Response||||0.1093
91576577|NCT00384774|183041084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364|||||||Fisher Exact|||Headache Response||||0.3364
91576578|NCT05262517|183041098|OTHER||Least square (LS) mean difference|-0.15|||||TWO_SIDED|95.0|-1.78|1.48||||||LS means and CIs were estimated by an analysis of covariance (ANCOVA) model, using restricted maximum likelihood (REML) with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||1.48|-1.78|
91576579|NCT05262517|183041099|OTHER||LS mean difference|5.12|||||TWO_SIDED|95.0|-21.35|31.59||||||LS means and CIs were estimated by an analysis of covariance model using REML with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||31.59|-21.35|
91576580|NCT05262517|183041100|OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.99|1.41||||||LS means, and CIs were based on a generalized linear mixed effect model (GLMEM) that included the baseline value as a covariate and fixed effects for treatment group, stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms; yes or no), scheduled time point, and time point by-treatment group interaction.||1.41|-0.99|
91576581|NCT05262517|183041101|OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-21.3|10.9||||||Stratified by use of daily medications/ oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenzsel weighting.||10.9|-21.3|
91576582|NCT05262517|183041104|OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.7|16.6||||||Stratified by use of daily medications/oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenszel weighting.||16.6|-8.7|
91576583|NCT00186017|183041105|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
91576584|NCT00186017|183041106|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
91576585|NCT00186017|183041107|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
91576586|NCT03296800|183041110|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|118.66|||||TWO_SIDED|90.0|111.12|126.72|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||126.72|111.12|
91576587|NCT03296800|183041110|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|119.62|||||TWO_SIDED|90.0|94.39|151.59||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|151.59|94.39|
91576588|NCT03296800|183041110|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|106.05|||||TWO_SIDED|90.0|88.81|126.65||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|126.65|88.81|
91576589|NCT03296800|183041113|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|140.98|||||TWO_SIDED|90.0|131.39|151.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||151.26|131.39|
91576590|NCT03296800|183041113|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|86.12|||||TWO_SIDED|90.0|70.24|105.59|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||105.59|70.24|
91576591|NCT03296800|183041113|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|97.93|||||TWO_SIDED|90.0|90.26|106.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||106.26|90.26|
91576592|NCT00478192|183041222|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.028
91576593|NCT00478192|183041222|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.019
91576594|NCT00478192|183041222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||<0.001
91576595|NCT00478192|183041227|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
91576596|NCT00477490|183041236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9303|TWO_SIDED|95.0|-0.221|0.242||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.242|-0.221|0.9303
91576597|NCT00477490|183041236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3104|TWO_SIDED|95.0|-0.353|0.112||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.112|-0.353|0.3104
91576598|NCT00477490|183041236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277||||0.0207|TWO_SIDED|95.0|-0.511|-0.042||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.042|-0.511|0.0207
91576599|NCT00477490|183041236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.848|-0.378||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.378|-0.848|<0.0001
91576600|NCT00477490|183041237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.017||||0.942|TWO_SIDED|95.0|0.647|1.598||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids||||1.598|0.647|0.9420
91576601|NCT00477490|183041237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.147||||0.5527|TWO_SIDED|95.0|0.729|1.807||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||1.807|0.729|0.5527
91576602|NCT00477490|183041237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.296||||0.2662|TWO_SIDED|95.0|0.821|2.05||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||2.050|0.821|0.2662
91576603|NCT00477490|183041237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.893|||<|0.0001|TWO_SIDED|95.0|1.795|4.715||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||4.715|1.795|<0.0001
91576604|NCT00137969|183041248|SUPERIORITY_OR_OTHER|||||||0.4875||||||One-sided p-value.|Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.4875
91576605|NCT00137969|183041249|SUPERIORITY_OR_OTHER|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.8230
91576606|NCT00137969|183041250|SUPERIORITY_OR_OTHER|||||||0.4318|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.4318
91576607|NCT00137969|183041251|SUPERIORITY_OR_OTHER|||||||0.9069|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.9069
91576608|NCT00137969|183041252|SUPERIORITY_OR_OTHER|||||||0.5602|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.5602
91576609|NCT00137969|183041253|SUPERIORITY_OR_OTHER|||||||0.8979|||||||Log Rank|||Stratified by randomization factors (race and initial prednisone dose)||||0.8979
91576610|NCT00137969|183041254|SUPERIORITY_OR_OTHER|||||||0.1277|||||||ANCOVA|||Stratified by randomization factors (race and initial prednisone dose)||||0.1277
91576611|NCT00137969|183041255|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.6202
91576612|NCT01465763|183041256|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||16.3|4.3|0.0070
91576613|NCT01465763|183041257|SUPERIORITY_OR_OTHER||Percent Difference|15.7||||0.0005|TWO_SIDED|95.0|8.1|23.4|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.4|8.1|0.0005
91576614|NCT01465763|183041258|SUPERIORITY_OR_OTHER||Percent Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.7|36.5|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.5|17.7|<0.0001
91576615|NCT01465763|183041259|SUPERIORITY_OR_OTHER||Percent Difference|5.1||||0.0345|TWO_SIDED|95.0|1.9|8.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.3|1.9|0.0345
91576616|NCT01465763|183041260|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.3|4.3|0.0070
91576617|NCT01465763|183041261|SUPERIORITY_OR_OTHER||Percent Difference|6.0||||0.0601|TWO_SIDED|95.0|1.0|11.1|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.1|1.0|0.0601
91576618|NCT01465763|183041262|SUPERIORITY_OR_OTHER||Percent Difference|6.5||||0.0043|TWO_SIDED|95.0|4.3|8.7|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.7|4.3|0.0043
91576619|NCT01465763|183041264|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed-Effects Model|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.5|-1.3|<0.0001
91576620|NCT01465763|183041264|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed-Effects Model|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.7|-1.5|<0.0001
91576621|NCT01465763|183041264|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.9|-1.1|||Mixed-Effects Model|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-1.1|-1.9|<0.0001
91576622|NCT01465763|183041265|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.5|-1.4|||ANCOVA|||The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.4|-2.5|<0.0001
91576623|NCT01646177|183041266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576624|NCT01646177|183041266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576625|NCT01646177|183041266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576626|NCT01646177|183041267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576627|NCT01646177|183041267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576628|NCT01646177|183041267|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576629|NCT01646177|183041268|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576630|NCT01646177|183041268|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576631|NCT01646177|183041268|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576632|NCT01646177|183041269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576633|NCT01646177|183041269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576634|NCT01646177|183041269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576635|NCT01646177|183041270|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576636|NCT01646177|183041270|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576637|NCT01646177|183041270|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576638|NCT01646177|183041271|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576639|NCT01646177|183041271|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576640|NCT01646177|183041271|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576641|NCT01646177|183041272|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576642|NCT01646177|183041272|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576643|NCT01646177|183041272|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576644|NCT01646177|183041273|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576645|NCT01646177|183041273|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576646|NCT01646177|183041273|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576647|NCT01646177|183041274|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576648|NCT01646177|183041274|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576649|NCT01646177|183041274|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576650|NCT01646177|183041275|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576651|NCT01646177|183041275|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576652|NCT01646177|183041275|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576653|NCT01646177|183041276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473|TWO_SIDED||||||ANCOVA|||||||0.473
91576654|NCT01646177|183041276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||ANCOVA|||||||0.015
91576655|NCT01646177|183041276|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
91576656|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.006
91576657|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.045
91576658|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.012
91576659|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
91576660|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
91576661|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
91576662|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
91576663|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
91576664|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
91576665|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
91576666|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
91576667|NCT01646177|183041277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
91576668|NCT01646177|183041278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
91576669|NCT01646177|183041278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
91576670|NCT01646177|183041278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
91576671|NCT01646177|183041278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||0.031
91576672|NCT01646177|183041278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
91576673|NCT01646177|183041278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
91576674|NCT01646177|183041279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576675|NCT01646177|183041279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576676|NCT01646177|183041279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
91576677|NCT01646177|183041280|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576678|NCT01646177|183041280|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576679|NCT01646177|183041280|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576680|NCT01646177|183041281|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576681|NCT01646177|183041281|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576682|NCT01646177|183041281|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576683|NCT01646177|183041282|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576684|NCT01646177|183041282|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576685|NCT01646177|183041282|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
91576686|NCT01038427|183041286|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|106.644|||||TWO_SIDED|90.0|91.86|123.997||||||||123.997|91.860|
91576687|NCT01038427|183041287|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91576688|NCT01038427|183041287|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
91576689|NCT01038427|183041288|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|109.716|||||TWO_SIDED|90.0|93.316|129.159||||||||129.159|93.316|
91576690|NCT01038427|183041289|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91576691|NCT01038427|183041289|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91576692|NCT01038427|183041290|SUPERIORITY|||||||0.2655|||||||Cochran-Mantel-Haenszel|||||||0.2655
91576693|NCT01038427|183041290|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||||||0.0009
91576694|NCT01038427|183041290|SUPERIORITY|||||||0.1093|||||||Cochran-Mantel-Haenszel|||||||0.1093
91576695|NCT01038427|183041291|SUPERIORITY|||||||0.9915|||||||Cochran-Mantel-Haenszel|||||||0.9915
91576696|NCT01038427|183041291|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
91576697|NCT01038427|183041291|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
91576698|NCT02992691|183041292|OTHER||Mean Difference (Net)|-0.01||||0.6674|TWO_SIDED|95.0|-0.06|0.04||From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.|ANCOVA|||This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments||0.04|-0.06|0.6674
91576699|NCT00588692|183041295|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For 25-49% Ejection Fraction Subgroup||||<0.05
91576700|NCT00588692|183041295|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||35-49% Ejection Fraction Subgroup||||<0.05
91576701|NCT00588692|183041297|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
91576702|NCT00588692|183041298|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||||||0.5
91576703|NCT00588692|183041298|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576704|NCT00588692|183041298|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576705|NCT00588692|183041299|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
91576706|NCT00588692|183041299|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576707|NCT00588692|183041299|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576708|NCT00588692|183041300|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
91576709|NCT00588692|183041301|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
91576710|NCT00588692|183041301|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576711|NCT00588692|183041301|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576712|NCT00588692|183041302|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
91576713|NCT00588692|183041303|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
91576714|NCT00588692|183041304|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||||||0.3
91576715|NCT00588692|183041305|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
91576716|NCT00588692|183041305|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576717|NCT00588692|183041305|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
91576718|NCT00588692|183041306|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||||||0.6
91576719|NCT00588692|183041307|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
91576720|NCT00588692|183041307|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576721|NCT00588692|183041307|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576722|NCT00588692|183041308|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||||||0.11
91576723|NCT00588692|183041308|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576724|NCT00588692|183041308|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
91576725|NCT00588692|183041309|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
91576726|NCT00588692|183041309|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576727|NCT00588692|183041309|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576728|NCT00588692|183041310|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
91576729|NCT00588692|183041310|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576730|NCT00588692|183041310|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
91576731|NCT00755105|183041327|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||< 0.05
91576732|NCT03995316|183041328|SUPERIORITY||Slope|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.003
91576733|NCT03995316|183041329|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.283|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.283
91576734|NCT03995316|183041330|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.22||0.019|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.019
91576735|NCT03995316|183041331|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.44||0.44|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.440
91576736|NCT03995316|183041332|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.055|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.055
91576737|NCT03995316|183041333|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.041|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.041
91576738|NCT03651700|183041371|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91576739|NCT03651700|183041372|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91576740|NCT05479734|183041374|SUPERIORITY|Expected Outcomes: greater number of activities while receiving parenting tips.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported when significant.||Null hypothesis is the number of positive activities engaged in with the child will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean activity counts on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.01
91576741|NCT05479734|183041375|SUPERIORITY||||||<|1||||||Test was performed with a significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. A randomization group difference over time is reported if significant.||Null hypothesis is that the mean positive parenting subscale score would not change from the baseline to the post-intervention assessment. Mixed effects models were performed regressing mean subscale scores on a timeframe (baseline vs post) indicator and a randomization group (early vs late app-delivered parenting tips) indicator. A randomization group difference over time was evaluated. This interaction effect was not included in the final statistical model unless statistically significant.||||<1.00
91576742|NCT05479734|183041376|SUPERIORITY||||||<|0.14||||||Test was performed with a significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported when significant.||Null hypothesis is that the number of hours spent with the child will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean number of hours on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.14
91576743|NCT05479734|183041377|OTHER|The model tested the significance of a non-zero location of the data. Effects significantly greater than zero reflect endorsement of app helpfulness.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis was that the app was only slightly helpful (scored 0). A Wilcoxon signed rank test was first performed to evaluate potential differences across randomization groups (early vs late app-delivered parenting tips). When the test of a randomization group difference was not significant, the analysis continued with a one-sample Wilcoxon signed rank test.||||<0.01
91576744|NCT05479734|183041378|OTHER|The model tested the significance of a non-zero location of the data. Effects significantly greater than zero reflect endorsement of future app use.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there would only be slight interest (scored 0) in using the app in the future. A Wilcoxon signed rank test was, first, performed to evaluate potential differences across randomization groups (early vs late app-delivered parenting tips). When the test of a randomization group difference was not significant, the analysis continued with a one-sample Wilcoxon signed rank test.||||<0.01
91576745|NCT05479734|183041379|OTHER|The model tested the significance of a non-zero location of the data. Effects significantly greater than zero reflect a desire to recommend the app.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis was that the participant was neither likely nor unlikely (scored 0) to recommend the app to friends. A Wilcoxon signed rank test was, first, performed to evaluate potential differences across randomization groups (early vs late app-delivered parenting tips). When the test of a randomization group difference was not significant, the analysis continued with a one-sample Wilcoxon signed rank test.||||<0.01
91576746|NCT05479734|183041380|SUPERIORITY||||||<|0.54||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. A randomization group difference over time is reported if significant.||Null hypothesis is that the mean general development scale score would not change from the baseline to the post-intervention assessment. Mixed effects models were performed regressing mean scale scores on a timeframe (baseline vs post) indicator and a randomization group (early vs late app-delivered parenting tips) indicator.||||<0.54
91576747|NCT05479734|183041381|SUPERIORITY||||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported if significant.||Null hypothesis is that the number of challenging child behaviors will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean behavior counts on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.01
91576748|NCT05479734|183041382|SUPERIORITY|Expected Outcomes: greater number of behaviors while receiving parenting tips.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported if significant.||Null hypothesis is that the daily number of positive child behaviors will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean behavior counts on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.01
91576749|NCT03168542|183041389|SUPERIORITY|Superiority was concluded if the lower 95% of the confidence limit of the proportion of subjects who require no more than one modification was greater than 50%.|Proportion|0.952|||||TWO_SIDED|95.0|0.756|1.0|||Agresti-Coull confidence interval|Agresti-Coull method was used to estimate the confidence interval of the binomial proportions.||||1.000|0.756|
91576750|NCT00455741|183041402|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||effect of age on estrogen negative feedback ( nadir LH as % of baseline LH)||||0.90
91576751|NCT00455741|183041402|SUPERIORITY||||||<|0.03||||||a priori threshold for significance is p\<0.05|ANOVA|||positive feedback||||<0.03
91576752|NCT00455741|183041403|SUPERIORITY||||||=|0.03||||||a priori significance level p\<0.05|ANOVA|||||||=0.03
91576753|NCT00455741|183041404|SUPERIORITY|||||||0.49||||||threshold for significance p\<0.05|t-test, 2 sided|||||||0.49
91576754|NCT00455741|183041405|SUPERIORITY||||||<|0.02||||||a priori threshold for significance p\<0.05|t-test, 2 sided|||||||<0.02
91576755|NCT00455741|183041406|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
91576756|NCT00455741|183041407|SUPERIORITY|||||||0.07||||||a priori significance set at p\<0.05|t-test, 2 sided|||||||0.07
91576757|NCT00203268|183041408|SUPERIORITY_OR_OTHER|||||||0.3025|||||||clustered survival analysis|||||||.3025
91576758|NCT00664534|183041410|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm|Least squares mean difference|-0.14|||||TWO_SIDED|95.0|-0.42|0.13|||||Least squares mean difference = (Premix insulin Lispro -Glargine)|||0.13|-0.42|
91576759|NCT00664534|183041412|SUPERIORITY_OR_OTHER||Least squares mean difference|0.05|||||TWO_SIDED|95.0|-0.18|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks|||0.29|-0.18|
91576760|NCT00664534|183041412|SUPERIORITY_OR_OTHER||Least squares mean difference|0.04|||||TWO_SIDED|95.0|-0.22|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks|||0.29|-0.22|
91576761|NCT00664534|183041412|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.08|||||TWO_SIDED|95.0|-0.33|0.18|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks|||0.18|-0.33|
91576762|NCT00664534|183041413|SUPERIORITY_OR_OTHER|||||||0.2127||95.0||||P-value is for Week 16 HbA1c \<=7.0%.|Chi-squared|||||||0.2127
91576763|NCT00664534|183041413|SUPERIORITY_OR_OTHER|||||||0.3281||95.0||||P-value is for Week 16 HbA1c \<=6.5%|Chi-squared|||||||0.3281
91576764|NCT00664534|183041413|SUPERIORITY_OR_OTHER|||||||0.2812||95.0||||P-value is for Week 32 HbA1c \<=7.0%|Chi-squared|||||||0.2812
91576765|NCT00664534|183041413|SUPERIORITY_OR_OTHER|||||||0.6963||95.0||||P-value is for Week 32 HbA1c \<=6.5%|Chi-squared|||||||0.6963
91576766|NCT00664534|183041413|SUPERIORITY_OR_OTHER|||||||0.0643||95.0||||P-value is for Week 48 HbA1c \<=7.0%|Chi-squared|||||||0.0643
91576767|NCT00664534|183041413|SUPERIORITY_OR_OTHER|||||||0.2524||95.0||||P-value is for Week 48 HbA1c \<=6.5%|Chi-squared|||||||0.2524
91576768|NCT00664534|183041415|SUPERIORITY_OR_OTHER|||||||0.6615||95.0||||P-value for Baseline|Wilcoxon (Mann-Whitney)|||||||0.6615
91576769|NCT00664534|183041415|SUPERIORITY_OR_OTHER|||||||0.9798||95.0||||P-value is for Week 16|Wilcoxon (Mann-Whitney)|||||||0.9798
91576770|NCT00664534|183041415|SUPERIORITY_OR_OTHER|||||||0.6169||95.0||||P-value for Week 32|Wilcoxon (Mann-Whitney)|||||||0.6169
91576771|NCT00664534|183041415|SUPERIORITY_OR_OTHER|||||||0.7834||95.0||||P-value for Week 48|Wilcoxon (Mann-Whitney)|||||||0.7834
91576772|NCT00664534|183041417|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.89|0.7|||||Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.|||0.70|-0.89|
91576773|NCT00664534|183041418|SUPERIORITY_OR_OTHER|||||||0.4935||95.0|||||Fisher Exact|||||||0.4935
91576774|NCT03041792|183041439|SUPERIORITY||Least Square Mean Difference|-235.75|STANDARD_ERROR_OF_MEAN|43.13||0|TWO_SIDED|95.0|-322.25|-149.25||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-149.25|-322.25|0.0000
91576775|NCT03041792|183041439|SUPERIORITY||Least Square Mean Difference|-243.63|STANDARD_ERROR_OF_MEAN|47.6||0|TWO_SIDED|95.0|-339.1|-148.15||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-148.15|-339.10|0.0000
91576776|NCT03041792|183041444|SUPERIORITY||Least Square Mean Difference|-859.58|STANDARD_ERROR_OF_MEAN|167.76||0|TWO_SIDED|95.0|-1196.1|-523.1||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-523.10|-1196.1|0.0000
91576777|NCT03041792|183041444|SUPERIORITY||Least Square Mean Difference|-928.56|STANDARD_ERROR_OF_MEAN|193.8||0|TWO_SIDED|95.0|-1317.3|-539.86||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-539.86|-1317.3|0.0000
91576778|NCT03041792|183041445|SUPERIORITY||Least Square Mean Difference|4.95|STANDARD_ERROR_OF_MEAN|2.16||0.0263|TWO_SIDED|95.0|0.61|9.29|||Mixed Models Analysis|||Visit 4||9.29|0.61|0.0263
91576779|NCT03041792|183041445|SUPERIORITY||Least Square Mean Difference|5.35|STANDARD_ERROR_OF_MEAN|2.06||0.0121|TWO_SIDED|95.0|1.22|9.48|||Mixed Models Analysis|||Visit 5||9.48|1.22|0.0121
91576780|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|3.98|STANDARD_ERROR_OF_MEAN|2.91||0.1768|TWO_SIDED|95.0|-1.85|9.82|||Mixed Models Analysis|||Satiety (Visit 4)||9.82|-1.85|0.1768
91576781|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|2.13||0.1137|TWO_SIDED|95.0|-0.85|7.7|||Mixed Models Analysis|||Satiety (Visit 5)||7.70|-0.85|0.1137
91576782|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|2.12||0.1858|TWO_SIDED|95.0|-1.41|7.11|||Mixed Models Analysis|||Fullness (Visit 4)||7.11|-1.41|0.1858
91576783|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|1.41|STANDARD_ERROR_OF_MEAN|2.22||0.5288|TWO_SIDED|95.0|-3.05|5.86|||Mixed Models Analysis|||Fullness (Visit 5)||5.86|-3.05|0.5288
91576784|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|-8.46|STANDARD_ERROR_OF_MEAN|2.91||0.0054|TWO_SIDED|95.0|-14.3|-2.61|||Mixed Models Analysis|||Prospective food consumption (Visit 4)||-2.61|-14.30|0.0054
91576785|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|-9.78|STANDARD_ERROR_OF_MEAN|3.75||0.0117|TWO_SIDED|95.0|-17.29|-2.27|||Mixed Models Analysis|||Prospective food consumption (Visit 5)||-2.27|-17.29|0.0117
91576786|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|2.44||0.0093|TWO_SIDED|95.0|-11.48|-1.69|||Mixed Models Analysis|||Hunger (Visit 4)||-1.69|-11.48|0.0093
91576787|NCT03041792|183041446|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.86||0.0296|TWO_SIDED|95.0|-12.12|-0.66|||Mixed Models Analysis|||Hunger (Visit 5)||-0.66|-12.12|0.0296
91576788|NCT03041792|183041447|SUPERIORITY||Least Square Mean Difference|35.56|STANDARD_ERROR_OF_MEAN|52.46||0.5008|TWO_SIDED|95.0|-69.64|140.76|||Mixed Models Analysis|||AUC0-60min (Visit 4)||140.76|-69.64|0.5008
91576789|NCT03041792|183041447|SUPERIORITY||Least Square Mean Difference|106.15|STANDARD_ERROR_OF_MEAN|48.95||0.0348|TWO_SIDED|95.0|7.86|204.44|||Mixed Models Analysis|||AUC0-60min (Visit 5)||204.44|7.86|0.0348
91576790|NCT03041792|183041447|SUPERIORITY||Least Square Mean Difference|214.24|STANDARD_ERROR_OF_MEAN|129.48||0.104|TWO_SIDED|95.0|-45.59|474.07|||Mixed Models Analysis|||AUC0-300min (Visit 4)||474.07|-45.59|0.1040
91576791|NCT03041792|183041447|SUPERIORITY||Least Square Mean Difference|348.43|STANDARD_ERROR_OF_MEAN|138.29||0.0152|TWO_SIDED|95.0|70.2|626.66|||Mixed Models Analysis|||AUC0-300min (Visit 5)||626.66|70.20|0.0152
91576792|NCT00935532|183041454|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\<8.5%, \>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.|Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.59|-0.26||No adjustments for multiplicity will be performed|ANCOVA|||The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).||-0.26|-0.59|<.001
91576793|NCT00935532|183041455|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
91576794|NCT00935532|183041456|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
91576795|NCT00935532|183041457|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.28|STANDARD_ERROR_OF_MEAN|3.23||0.103|TWO_SIDED|95.0|-11.62|1.07|||ANCOVA|||Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.||1.07|-11.62|0.103
91576796|NCT00935532|183041458|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.46|-1.56|||ANCOVA|||Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.||-1.56|-2.46|<.001
91576797|NCT00935532|183041459|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-12.33|-3.45|||ANCOVA|||Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.||-3.45|-12.33|<.001
91576798|NCT00935532|183041460|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.69||0.689|TWO_SIDED|95.0|-1.64|1.09|||ANCOVA|||Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.||1.09|-1.64|0.689
91576799|NCT00935532|183041461|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.03||0.99|TWO_SIDED|95.0|0.94|1.06|||ANCOVA|||Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.||1.06|0.94|0.990
91576800|NCT01460225|183041485|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.003|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal||||0.003
91576801|NCT01460225|183041485|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.122|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal||||0.122
91576802|NCT03083665|183041489|SUPERIORITY||Percent reduction over Placebo|24.5||||0.0005|TWO_SIDED|95.0|11.7|35.5||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||35.5|11.7|0.0005
91576803|NCT03083665|183041489|SUPERIORITY||Percent reduction over Placebo|33.4|||<|0.0001|TWO_SIDED|95.0|21.9|43.1||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||43.1|21.9|<0.0001
91576804|NCT04103892|183041544|SUPERIORITY||Least square (LS) mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.69||0.46|TWO_SIDED|95.0|-4.6|2.09|||Mixed Models Repeated Measures (MMRM|||||2.09|-4.60|0.46
91576805|NCT04103892|183041545|SUPERIORITY||Least square (LS) mean difference|-5.28|STANDARD_ERROR_OF_MEAN|2.34||0.03|TWO_SIDED|95.0|-9.91|-0.65|||Mixed Models Repeated Measures (MMRM)|||||-0.65|-9.91|0.03
91576806|NCT05576662|183041546|OTHER||Pooled treatment coefficient|0.026||||0.903|TWO_SIDED|||||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Nonparametric permutation test||Weighted average of treatment coefficients. A pooled treatment coefficient \< 0 favors nirmatrelvir plus ritonavir; a pooled treatment coefficient \> 0 favors placebo plus ritonavir.|A proportional odds logistic regression model was fit for severity of each core symptom at week 10, adjusting for baseline severity of the corresponding symptom and fit using only those who experienced the symptom at baseline. A test statistic for overall efficacy was calculated as the weighted average of the treatment coefficient in the proportional odds model for each symptom with inverse variance weighting. The p-value was obtained by a nonparametric permutation test.||||0.903
91576807|NCT05576662|183041547|OTHER||Odds Ratio (OR)|1.55||||0.174|TWO_SIDED|95.0|0.82|2.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of fatigue score at day 15||2.94|0.82|0.174
91576808|NCT05576662|183041547|OTHER||Odds Ratio (OR)|1.21||||0.548|TWO_SIDED|95.0|0.65|2.25||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of brain fog score at day 15||2.25|0.65|0.548
91576809|NCT05576662|183041547|OTHER||Odds Ratio (OR)|0.62||||0.134|TWO_SIDED|95.0|0.33|1.16||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of dyspnea score at day 15||1.16|0.33|0.134
91576810|NCT05576662|183041547|OTHER||Odds Ratio (OR)|1.45||||0.241|TWO_SIDED|95.0|0.78|2.69||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of body aches score at day 15||2.69|0.78|0.241
91576811|NCT05576662|183041547|OTHER||Odds Ratio (OR)|1.03||||0.922|TWO_SIDED|95.0|0.55|1.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of gastrointestinal symptoms score at day 15||1.92|0.55|0.922
91576812|NCT05576662|183041547|OTHER||Odds Ratio (OR)|0.5||||0.032|TWO_SIDED|95.0|0.26|0.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of cardiovascular symptoms score at day 15||0.94|0.26|0.032
91576813|NCT05576662|183041548|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.09||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||1.09|0.27|0.09
91576814|NCT05576662|183041549|OTHER||Odds Ratio (OR)|0.72||||0.6|TWO_SIDED|95.0|0.21|2.44||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||2.44|0.21|.60
91576815|NCT05576662|183041550|OTHER||Odds Ratio (OR)|1.62||||0.156|TWO_SIDED|95.0|0.83|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 5||3.15|0.83|0.156
91576816|NCT05576662|183041550|OTHER||Odds Ratio (OR)|1.99||||0.03|TWO_SIDED|95.0|1.06|3.72||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 10||3.72|1.06|0.03
91576817|NCT05576662|183041550|OTHER||Odds Ratio (OR)|2.42||||0.01|TWO_SIDED|95.0|1.27|4.6||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 15||4.60|1.27|0.01
91576818|NCT05576662|183041551|OTHER||Hazard Ratio (HR)|0.9||||0.744|TWO_SIDED|95.0|0.45|1.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - fatigue"||1.77|0.45|0.744
91576819|NCT05576662|183041551|OTHER||Hazard Ratio (HR)|0.67||||0.259|TWO_SIDED|95.0|0.32|1.37||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - brain fog"||1.37|0.32|0.259
91576820|NCT05576662|183041551|OTHER||Hazard Ratio (HR)|1.61||||0.286|TWO_SIDED|95.0|0.65|3.99||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - body aches"||3.99|0.65|0.286
91576821|NCT05576662|183041551|OTHER||Hazard Ratio (HR)|0.92||||0.846|TWO_SIDED|95.0|0.38|2.24||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - cardiovascular symptoms"||2.24|0.38|0.846
91576822|NCT05576662|183041551|OTHER||Hazard Ratio (HR)|1.56||||0.41|TWO_SIDED|95.0|0.51|4.73||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test|A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.||"Analysis of data for Time to relief - shortness of breath"||4.73|0.51|0.410
91576823|NCT05576662|183041551|OTHER||Hazard Ratio (HR)|0.94||||0.88|TWO_SIDED|95.0|0.42|2.11||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - gastrointestinal symptoms"||2.11|0.42|0.880
91576824|NCT05576662|183041552|OTHER||Hazard Ratio (HR)|0.74||||0.33|TWO_SIDED|95.0|0.4|1.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|||1.38|0.40|0.33
91576825|NCT05576662|183041553|OTHER||Mean Difference (Net)|0.57||||0.66|TWO_SIDED|95.0|-1.96|3.1||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.10|-1.96|.66
91576826|NCT05576662|183041554|OTHER||Mean Difference (Net)|0.38||||0.79|TWO_SIDED|95.0|-2.4|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.15|-2.40|0.79
91576827|NCT05576662|183041555|OTHER||Mean Difference (Net)|0.6||||0.7|TWO_SIDED|95.0|-2.55|3.75||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.75|-2.55|.70
91576828|NCT05576662|183041556|OTHER||Mean Difference (Net)|0.03||||0.98|TWO_SIDED|95.0|-3.21|3.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.28|-3.21|.98
91576829|NCT05576662|183041557|OTHER||Mean Difference (Net)|1.73||||0.555|TWO_SIDED|95.0|-4.06|7.53||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of systolic blood pressure||7.53|-4.06|0.555
91576830|NCT05576662|183041557|OTHER||Mean Difference (Net)|-0.68||||0.764|TWO_SIDED|95.0|-5.15|3.79||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of diastolic blood pressure||3.79|-5.15|0.764
91576831|NCT05576662|183041558|OTHER||Mean Difference (Net)|-0.51||||0.856|TWO_SIDED|95.0|-6.15|5.12||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||5.12|-6.15|0.856
91576832|NCT05576662|183041559|OTHER||Mean Difference (Net)|-0.41||||0.833|TWO_SIDED|95.0|-4.24|3.42||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.42|-4.24|0.833
91576833|NCT05576662|183041560|OTHER||Mean Difference (Final Values)|0.32||||0.096|TWO_SIDED|95.0|-0.06|0.7||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.70|-0.06|0.096
91576834|NCT05576662|183041560|OTHER||Mean Difference (Final Values)|0.22||||0.293|TWO_SIDED|95.0|-0.2|0.64||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.64|-0.20|0.293
91576835|NCT05576662|183041560|OTHER||Mean Difference (Final Values)|0.19||||0.396|TWO_SIDED|95.0|-0.25|0.62||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.62|-0.25|0.396
91576836|NCT05576662|183041560|OTHER||Mean Difference (Final Values)|0.37||||0.064|TWO_SIDED|95.0|-0.02|0.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.77|-0.02|0.064
91576837|NCT05576662|183041561|OTHER||Mean Difference (Final Values)|0.19||||0.444|TWO_SIDED|95.0|-0.3|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.67|-0.30|0.444
91576838|NCT05576662|183041561|OTHER||Mean Difference (Final Values)|-0.25||||0.346|TWO_SIDED|95.0|-0.78|0.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.28|-0.78|0.346
91576839|NCT05576662|183041561|OTHER||Mean Difference (Final Values)|0.1||||0.738|TWO_SIDED|95.0|-0.48|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.67|-0.48|0.738
91576840|NCT05576662|183041561|OTHER||Mean Difference (Final Values)|0.17||||0.578|TWO_SIDED|95.0|-0.43|0.76||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.76|-0.43|0.578
91576841|NCT05576662|183041562|OTHER||Mean Difference (Final Values)|-0.19||||0.758|TWO_SIDED|95.0|-1.41|1.03||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||1.03|-1.41|0.758
91576842|NCT05576662|183041562|OTHER||Mean Difference (Final Values)|-0.24||||0.693|TWO_SIDED|95.0|-1.46|0.97||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.97|-1.46|0.693
91576843|NCT05576662|183041562|OTHER||Mean Difference (Final Values)|0.37||||0.558|TWO_SIDED|95.0|-0.87|1.61||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||1.61|-0.87|0.558
91576844|NCT05576662|183041563|OTHER||Odds Ratio (OR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of fatigue data||0.92|0.33|0.02
91576845|NCT05576662|183041563|OTHER||Odds Ratio (OR)|0.5||||0.01|TWO_SIDED|95.0|0.31|0.82||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of brain fog data||0.82|0.31|0.01
91576846|NCT05576662|183041563|OTHER||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.74|2.33||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of body aches data||2.33|0.74|0.34
91576847|NCT05576662|183041563|OTHER||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.76|2.48||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of cardiovascular symptoms data||2.48|0.76|0.29
91576848|NCT05576662|183041563|OTHER||Odds Ratio (OR)|1.32||||0.35|TWO_SIDED|95.0|0.73|2.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of shortness of breath data||2.38|0.73|0.35
91576849|NCT05576662|183041563|OTHER||Odds Ratio (OR)|1.4||||0.25|TWO_SIDED|95.0|0.79|2.47||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of gastrointestinal symptoms data||2.47|0.79|0.25
91576850|NCT03008005|183041575|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
91576851|NCT03008005|183041576|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
91576852|NCT02755129|183041577|OTHER||||||||||||||||||"To assess the similarity between the Reveal LINQ measures and those from the reference system, correlation coefficients were used.~The correlation coefficient was calculated over windows of 4 seconds and averaged for each exercise. Then, the average correlation coefficient over all patients and exercise was calculated."|||
91576853|NCT00475228|183041578|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
91576854|NCT04854850|183041609|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91576855|NCT04092530|183041613|OTHER||Risk Ratio (RR)|0.82||||0.12|TWO_SIDED|95.0|0.64|1.05|||Mixed Models Analysis|Adjusted for time; clustering by clinical site accounted for with random intercept||Please note that there were only 7 units (community health clinics) analyzed at Level 2 of this multilevel study, but due to the crossover design of the study, they were each observed under both the Control and Intervention conditions. Therefore, the Units Analyzed entered above reflect the 7 clinics under both conditions and should not be summed to 14.||1.05|0.64|0.12
91576856|NCT04092530|183041614|OTHER||Risk Ratio (RR)|0.89||||0.33|TWO_SIDED|95.0|0.7|1.13|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||1.13|0.70|0.33
91576857|NCT04092530|183041615|OTHER||Risk Ratio (RR)|1.1||||0.88|TWO_SIDED|95.0|0.33|3.73|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||3.73|0.33|0.88
91576858|NCT00288639|183041666|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.72|STANDARD_DEVIATION|55.232||||95.0|-34.16|-11.28|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-11.28|-34.16|
91576859|NCT00288639|183041667|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-17.26|STANDARD_DEVIATION|48.797||||95.0|-27.36|-7.15|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-7.15|-27.36|
91576860|NCT00288639|183041668|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.43|STANDARD_DEVIATION|56.615||||95.0|-34.16|-10.71|||||1-28 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts.Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-10.71|-34.16|
91576861|NCT00288639|183041668|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.83|STANDARD_DEVIATION|57.543||||95.0|-34.74|-10.91|||||29-56 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-10.91|-34.74|
91576862|NCT00288639|183041668|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-27.18|STANDARD_DEVIATION|59.323||||95.0|-39.9|-14.46|||||57-84 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. .|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-14.46|-39.90|
91576863|NCT00288639|183041668|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-30.75|STANDARD_DEVIATION|58.11||||95.0|-43.44|-18.06|||||85-112 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-18.06|-43.44|
91576864|NCT00288639|183041668|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-38.75|STANDARD_DEVIATION|59.368||||95.0|-51.79|-25.7|||||113-140 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-25.70|-51.79|
91576865|NCT00288639|183041668|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-44.24|STANDARD_DEVIATION|62.703||||95.0|-58.47|-30.01|||||\>140 Days. Response ratio= 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-30.01|-58.47|
91576866|NCT00288639|183041669|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|7.19|STANDARD_DEVIATION|84.425||||95.0|-17.6|31.98|||||Simple Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||31.98|-17.60|
91576867|NCT00288639|183041669|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.24|STANDARD_DEVIATION|68.058||||95.0|-37.8|-6.69|||||Complex Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.69|-37.80|
91576868|NCT00288639|183041669|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-23.85|STANDARD_DEVIATION|84.313||||95.0|-55.33|7.64|||||Evolved to Generalized. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||7.64|-55.33|
91576869|NCT00288639|183041673|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-24.93|STANDARD_DEVIATION|60.867||||95.0|-43.66|-6.2|||||Seizure freq. ≤3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.20|-43.66|
91576870|NCT00288639|183041673|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-20.78|STANDARD_DEVIATION|50.334||||95.0|-35.24|-6.33|||||Seizure freq. \>3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.33|-35.24|
91576871|NCT04421950|183041772|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
91576872|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference :|-13.5|||||TWO_SIDED|95.0|-18.3|-8.7|||||2-Sided 95% CIs were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1||-8.7|-18.3|
91576873|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-17.9|||||TWO_SIDED|95.0|-23.2|-12.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-12.4|-23.2|
91576874|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-11.0|||||TWO_SIDED|95.0|-16.0|-5.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||-5.9|-16.0|
91576875|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-12.6|||||TWO_SIDED|95.0|-17.8|-7.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||-7.2|-17.8|
91576876|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.1|||||TWO_SIDED|95.0|-19.5|-8.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||-8.6|-19.5|
91576877|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-15.8|||||TWO_SIDED|95.0|-21.0|-10.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||-10.6|-21.0|
91576878|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-2.6|||||TWO_SIDED|95.0|-6.3|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||1.1|-6.3|
91576879|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.3|||||TWO_SIDED|95.0|-19.7|-8.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||-8.9|-19.7|
91576880|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-3.3|||||TWO_SIDED|95.0|-7.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||1.4|-7.9|
91576881|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-5.5|||||TWO_SIDED|95.0|-10.6|-0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||-0.4|-10.6|
91576882|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.7|||||TWO_SIDED|95.0|-4.8|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.3|-4.8|
91576883|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.4|||||TWO_SIDED|95.0|-4.0|1.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.2|-4.0|
91576884|NCT04546425|183041783|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-18.3|||||TWO_SIDED|95.0|-23.6|-12.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||-12.9|-23.6|
91576885|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|59.9|||||TWO_SIDED|95.0|55.6|64.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||64.1|55.6|
91576886|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-7.6|||||TWO_SIDED|95.0|-13.1|-2.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 10A||-2.1|-13.1|
91576887|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.6|||||TWO_SIDED|95.0|53.1|61.9|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 11A||61.9|53.1|
91576888|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-6.2|||||TWO_SIDED|95.0|-11.7|-0.7|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 12F||-0.7|-11.7|
91576889|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 15B||62.1|53.3|
91576890|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 22F||62.1|53.3|
91576891|NCT04546425|183041783|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|10.3|||||TWO_SIDED|95.0|4.5|16.0|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 33F||16.0|4.5|
91576892|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.69|0.54|
91576893|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.79|0.64|
91576894|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.69|0.52|
91576895|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.70|0.52|
91576896|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.45|0.65|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.65|0.45|
91576897|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.51|||||TWO_SIDED|95.0|0.43|0.61|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.61|0.43|
91576898|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.64|
91576899|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.5|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.69|0.50|
91576900|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.96|0.70|
91576901|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.92|0.67|
91576902|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.69|0.51|
91576903|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.82|0.64|
91576904|NCT04546425|183041784|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.52|||||TWO_SIDED|95.0|0.44|0.62|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.62|0.44|
91576905|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.55|||||TWO_SIDED|95.0|22.98|30.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||30.67|22.98|
91576906|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.67|||||TWO_SIDED|95.0|2.25|3.17|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||3.17|2.25|
91576907|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|22.95|30.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||30.82|22.95|
91576908|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.48|||||TWO_SIDED|95.0|2.08|2.97|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||2.97|2.08|
91576909|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|54.6|||||TWO_SIDED|95.0|46.35|64.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||64.30|46.35|
91576910|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|36.8|||||TWO_SIDED|95.0|31.57|42.89|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||42.89|31.57|
91576911|NCT04546425|183041784|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.03|||||TWO_SIDED|95.0|4.27|5.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||5.92|4.27|
91576912|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.67|||||TWO_SIDED|95.0|0.6|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.75|0.60|
91576913|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.59|0.73|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.73|0.59|
91576914|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.87|0.68|
91576915|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.81|0.64|
91576916|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.75|0.57|
91576917|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.48|0.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.67|0.48|
91576918|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.67|
91576919|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.66|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.81|0.66|
91576920|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.92|0.69|
91576921|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.75|||||TWO_SIDED|95.0|0.67|0.84|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.84|0.67|
91576922|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.93|0.72|
91576923|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.87|0.68|
91576924|NCT04546425|183041785|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.69|0.52|
91576925|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.48|||||TWO_SIDED|95.0|1.32|1.66|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||1.66|1.32|
91576926|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.02|||||TWO_SIDED|95.0|1.77|2.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||2.30|1.77|
91576927|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||1.75|1.37|
91576928|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||0.87|0.68|
91576929|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.42|||||TWO_SIDED|95.0|4.82|6.1|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||6.10|4.82|
91576930|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|3.84|||||TWO_SIDED|95.0|3.4|4.34|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||4.34|3.40|
91576931|NCT04546425|183041785|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.64|||||TWO_SIDED|95.0|2.33|2.99|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||2.99|2.33|
91576932|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|-0.2|||||TWO_SIDED|95.0|-1.3|0.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Diphtheria||0.8|-1.3|
91576933|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-0.6|||||TWO_SIDED|95.0|-1.8|0.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Tetanus||0.2|-1.8|
91576934|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-2.3|||||TWO_SIDED|95.0|-5.3|0.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PT||0.7|-5.3|
91576935|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.2|||||TWO_SIDED|95.0|-2.6|2.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|FHA||2.9|-2.6|
91576936|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.6|||||TWO_SIDED|95.0|-0.9|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PRN||4.2|-0.9|
91576937|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.1|||||TWO_SIDED|95.0|-1.1|4.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hepatitis B||4.0|-1.1|
91576938|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 1||4.2|-4.6|
91576939|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 2||4.2|-4.6|
91576940|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 3||4.2|-4.6|
91576941|NCT04546425|183041786|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hib||2.2|-2.0|
91576942|NCT04546425|183041787|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.79|1.42|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Measles||1.42|0.79|
91576943|NCT04546425|183041788|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Mumps||1.44|0.76|
91576944|NCT04546425|183041789|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Rubella||1.10|0.63|
91576945|NCT04546425|183041790|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|0.98|1.57|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Varicella||1.57|0.98|
91576946|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.0|||||TWO_SIDED|95.0|-3.1|0.9|||||2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1 \\||0.9|-3.1|
91576947|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-10.6|||||TWO_SIDED|95.0|-14.7|-6.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-6.7|-14.7|
91576948|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||1.3|-1.4|
91576949|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.4|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||2.2|-1.4|
91576950|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||1.5|-1.6|
91576951|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||2.7|-1.1|
91576952|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||0.4|-1.5|
91576953|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.0|1.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||1.9|-1.0|
91576954|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.5|||||TWO_SIDED|95.0|-3.7|0.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||0.6|-3.7|
91576955|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|1.0|||||TWO_SIDED|95.0|-0.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||2.7|-0.5|
91576956|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.1|-1.1|
91576957|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.2|||||TWO_SIDED|95.0|-0.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.4|-0.9|
91576958|NCT04546425|183041804|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.9|||||TWO_SIDED|95.0|-3.2|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||1.4|-3.2|
91576959|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||3.9|0.4|
91576960|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 10A||2.7|-1.5|
91576961|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.2|||||TWO_SIDED|95.0|-0.7|3.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 11A||3.2|-0.7|
91576962|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|-0.6|||||TWO_SIDED|95.0|-2.9|1.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 12F||1.6|-2.9|
91576963|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.2|||||TWO_SIDED|95.0|0.7|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 15B||4.1|0.7|
91576964|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 22F||3.9|0.4|
91576965|NCT04546425|183041804|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.4|||||TWO_SIDED|95.0|-0.4|3.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 33F||3.4|-0.4|
91576966|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.5|||||TWO_SIDED|95.0|-11.2|2.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Diphtheria||2.1|-11.2|
91576967|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Tetanus||0.4|-7.0|
91576968|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-0.5|||||TWO_SIDED|95.0|-5.2|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PT||4.1|-5.2|
91576969|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|FHA||3.3|-6.4|
91576970|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PRN||3.3|-6.4|
91576971|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.3|||||TWO_SIDED|95.0|-10.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 1||2.2|-10.0|
91576972|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-2.8|||||TWO_SIDED|95.0|-11.8|5.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 2||5.8|-11.8|
91576973|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.2|||||TWO_SIDED|95.0|-10.2|-0.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 3||-0.5|-10.2|
91576974|NCT04546425|183041808|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|0.0|||||TWO_SIDED|95.0|-1.8|2.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Hib||2.0|-1.8|
91576975|NCT00672737|183041938|SUPERIORITY_OR_OTHER||Slope|0.0025|||<|0.05|TWO_SIDED|95.0|0.0009|0.0041|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level the cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0041|0.0009|<0.05
91576976|NCT00672737|183041938|SUPERIORITY_OR_OTHER||Slope|-0.9694||||0.05|TWO_SIDED|95.0|-1.9127|-0.0261|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2 the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0261|-1.9127|0.05
91576977|NCT00672737|183041939|SUPERIORITY_OR_OTHER||Slope|-0.0001|||<|0.05|TWO_SIDED|95.0|-0.0001|-0.0001|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0001|-0.0001|<0.05
91576978|NCT00672737|183041939|SUPERIORITY_OR_OTHER||Slope|-0.0172|||<|0.05|TWO_SIDED|95.0|-0.018|0.0556|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0556|-0.018|<0.05
91576979|NCT02193490|183041962|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91576980|NCT02193490|183041963|OTHER|||||||0.078|||||||Kruskal-Wallis|||||||0.078
91576981|NCT02193490|183041964|OTHER||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
91576982|NCT02299414|183041965|SUPERIORITY||Risk Ratio (RR)|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92|||Chi-squared|||||.92|.73|<0.001
91576983|NCT02299414|183041965|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.7|0.9||||||||.90|.70|
91576984|NCT02299414|183041965|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.6|0.89||||||||.89|.60|
91576985|NCT02299414|183041965|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.49|1.64||||||||1.64|.49|
91576986|NCT02299414|183041965|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.54|1.21||||||||1.21|.54|
91576987|NCT02299414|183041966|SUPERIORITY||Risk Ratio (RR)|1.07||||0.56|TWO_SIDED|95.0|0.85|1.36|||Chi-squared|||||1.36|0.85|0.56
91576988|NCT02299414|183041967|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.45|1.26||||||||1.26|.45|
91576989|NCT02299414|183041968|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.77|0.91||||||||0.91|0.77|
91576990|NCT02299414|183041969|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||||.99|.77|
91576991|NCT02299414|183041970|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.45|1.3||||||||1.3|.45|
91576992|NCT02299414|183041971|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||||1.18|.98|
91576993|NCT02299414|183041972|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.69|0.89||||||||.89|.69|
91576994|NCT02299414|183041973|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.68|1.04||||||||1.04|0.68|
91576995|NCT02299414|183041974|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||||.90|.74|
91576996|NCT02299414|183041975|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|.93|
91576997|NCT02299414|183041976|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.27||||||||1.27|.59|
91576998|NCT02299414|183041977|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.81|1.02||||||||1.02|.81|
91576999|NCT02299414|183041978|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.71|0.97||||||||.97|.71|
91577000|NCT02299414|183041979|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.11|0.43||||||||0.43|-0.11|
91577001|NCT02299414|183041980|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.05|0.56||||||||0.56|0.05|
91577002|NCT02299414|183041981|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-17.6|20.9||||||||20.9|-17.6|
91577003|NCT02299414|183041982|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|.81|
91577004|NCT02299414|183041983|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.55|1.42||||||||1.42|.55|
91577005|NCT02299414|183041984|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.18|1.05||||||||1.05|.18|
91577006|NCT02299414|183041985|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.71|1.06||||||||1.06|.71|
91577007|NCT02299414|183041986|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|.24|
91577008|NCT02299414|183041987|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.85|1.12||||||||1.12|.85|
91577009|NCT02299414|183041988|SUPERIORITY||Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.37||||||||1.37|0.30|
91577010|NCT02299414|183041989|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.14|7.06||||||||7.06|.14|
91577011|NCT02299414|183041990|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.81|1.08||||||||1.08|.81|
91577012|NCT02299414|183041991|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.62|1.16||||||||1.16|0.62|
91577013|NCT02299414|183041992|SUPERIORITY||Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.36|1.05||||||||1.05|.36|
91577014|NCT02299414|183041993|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.2|0.03||||||||0.03|-0.2|
91577015|NCT02299414|183041994|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
91577016|NCT02299414|183041995|SUPERIORITY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.12|0.002||||||||0.002|-0.12|
91577017|NCT02299414|183041996|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
91577018|NCT02299414|183041997|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.9|1.06||||||||1.06|0.90|
91577019|NCT04954326|183042022|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for AUCinf should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|102.8||||0.05|TWO_SIDED|90.0|91.4|115.6|||ANOVA|||AUCinf was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||115.6|91.4|0.05
91577020|NCT04954326|183042023|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cmax should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|93.5||||0.05|TWO_SIDED|90.0|82.9|105.5|||ANOVA|||Cmax was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||105.5|82.9|0.05
91577021|NCT04954326|183042024|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cday14 should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|121.5||||0.05|TWO_SIDED|90.0|98.7|149.6|||ANOVA|||Cday14 was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||149.6|98.7|0.05
91577022|NCT01310231|183042027|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.71|TWO_SIDED|95.0|0.63|2.31||One-sided p-value for group-effect obtained from Cox model. The prespecified threshold was 0.20 (one-sided).|Regression, Cox|Cox model for PFS with metf/plac and the two randomization stratification variables line of chemotherapy and hormone receptor status.|Ratio of hazard of progression in the Metformin group relative to hazard in the Placebo group|Power: Final study plan called for 40 progression events, giving 80% power to detect a hazard ratio (HR) of 0.58 for PFS with a one-sided type I error of 20%, where the relatively high type I error reflects the Phase II status of the trial||2.31|0.63|0.71
91577023|NCT01310231|183042028|SUPERIORITY||Odds Ratio (OR)|1.77||||0.41|TWO_SIDED|95.0|0.45|6.99||Two-side p-value from a logistic regression model.|Regression, Logistic|Logistic regression model included metf/plac and the two stratification variables line of chemotherapy and hormone receptor status.||||6.99|0.45|0.41
91577024|NCT01495598|183042038|OTHER|Other = Kaplan Meier||||||0.43|||||||Log Rank|||||||0.43
91577025|NCT01495598|183042048|OTHER|\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.19||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.19
91577026|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.72||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.72
91577027|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
91577028|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
91577029|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
91577030|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
91577031|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
91577032|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.06
91577033|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
91577034|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0003||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0003
91577035|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0002
91577036|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.01||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.01
91577037|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
91577038|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.91||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.91
91577039|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.64||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.64
91577040|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.7||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.70
91577041|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.59||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.59
91577042|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.26||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.26
91577043|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0008||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0008
91577044|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
91577045|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
91577046|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
91577047|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
91577048|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
91577049|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.42||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.42
91577050|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.85||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.85
91577051|NCT01495598|183042048|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.16||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.16
91577052|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.07||||||The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.07
91577053|NCT01495598|183042049|NON_INFERIORITY|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.13
91577054|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.15||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.15
91577055|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.03
91577056|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.06
91577057|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.79||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon rank sum test|||||||0.79
91577058|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.03
91577059|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.008||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.008
91577060|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.12||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.12
91577061|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
91577062|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
91577063|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.36
91577064|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.002
91577065|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.0002
91577066|NCT01495598|183042049|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||<0.0001
91577067|NCT01495598|183042050|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13|||||||Wilcoxon signed rank test|||||||0.13
91577068|NCT01495598|183042050|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
91577069|NCT01495598|183042050|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.32|||||||Wilcoxon signed rank test|||||||0.32
91577070|NCT01495598|183042050|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06|||||||Wilcoxon signed rank test|||||||0.06
91577071|NCT01495598|183042050|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007|||||||Wilcoxon signed rank test|||||||0.007
91577072|NCT01495598|183042051|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
91577073|NCT01495598|183042051|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
91577074|NCT01495598|183042051|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
91577075|NCT03635099|183042077|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
91577076|NCT03635099|183042077|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
91577077|NCT03635099|183042077|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
91577078|NCT03635099|183042077|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
91577079|NCT03635099|183042077|OTHER||Risk Difference (RD)|25.6|||||TWO_SIDED|95.0|12.5|38.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||38.6|12.5|
91577080|NCT03635099|183042077|OTHER||Risk Difference (RD)|23.8|||||TWO_SIDED|95.0|10.9|36.7|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.7|10.9|
91577081|NCT03635099|183042077|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0004
91577082|NCT03635099|183042077|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0012||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0012
91577083|NCT03635099|183042077|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0008||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0008
91577084|NCT03635099|183042077|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0217||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0217
91577085|NCT03635099|183042077|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
91577086|NCT03635099|183042078|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
91577087|NCT03635099|183042078|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
91577088|NCT03635099|183042078|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
91577089|NCT03635099|183042078|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
91577090|NCT03635099|183042078|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0007||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0007
91577091|NCT03635099|183042078|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0023||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0023
91514171|NCT04079933|182900463|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL|Mean Difference (Net)|-3.72||||0.9433|TWO_SIDED|95.0|-107.0|99.4|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL||99.4|-107|0.9433
91577092|NCT03635099|183042078|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0018||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0018
91577093|NCT03635099|183042078|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0386||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0386
91577094|NCT03635099|183042078|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
91577095|NCT03635099|183042079|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-11.7|11.7|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.7|-11.7|1.0000
91577096|NCT03635099|183042079|OTHER||Risk Difference (RD)|20.6||||0.054|TWO_SIDED|95.0|3.9|37.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||37.3|3.9|0.0540
91577097|NCT03635099|183042079|OTHER||Risk Difference (RD)|15.5||||0.1167|TWO_SIDED|95.0|-0.4|31.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||31.4|-0.4|0.1167
91577098|NCT03635099|183042079|OTHER||Risk Difference (RD)|45.0||||0.0006|TWO_SIDED|95.0|26.8|63.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||63.2|26.8|0.0006
91577099|NCT03635099|183042079|OTHER||Risk Difference (RD)|45.8|||||TWO_SIDED|95.0|22.0|69.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||69.6|22.0|
91577100|NCT03635099|183042079|OTHER||Risk Difference (RD)|35.2|||||TWO_SIDED|95.0|11.3|59.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||59.2|11.3|
91577101|NCT03635099|183042080|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
91577102|NCT03635099|183042080|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
91577103|NCT03635099|183042080|OTHER||Risk Difference (RD)|17.5||||0.0465|TWO_SIDED|95.0|5.7|29.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||29.3|5.7|0.0465
91577104|NCT03635099|183042080|OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|0.6|18.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||18.0|0.6|
91577105|NCT03635099|183042080|OTHER||Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-1.7|11.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||11.2|-1.7|
91577106|NCT03635099|183042081|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
91577107|NCT03635099|183042081|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
91577108|NCT03635099|183042081|OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-2.2|6.8|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||6.8|-2.2|
91577109|NCT03635099|183042081|OTHER||Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.2|7.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||7.0|-2.2|
91577110|NCT03635099|183042082|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
91577111|NCT03635099|183042082|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
91577112|NCT03635099|183042082|OTHER||Risk Difference (RD)|12.8||||0.0942|TWO_SIDED|95.0|2.3|23.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||23.3|2.3|0.0942
91577113|NCT03635099|183042082|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
91577114|NCT03635099|183042082|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
91577115|NCT03635099|183042082|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
91577116|NCT03635099|183042082|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
91577117|NCT03635099|183042082|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
91577118|NCT03635099|183042082|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
91577119|NCT03635099|183042082|OTHER||Risk Difference (RD)|35.0||||0.0025|TWO_SIDED|95.0|20.2|49.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||49.8|20.2|0.0025
91577120|NCT03635099|183042083|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
91577121|NCT03635099|183042083|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
91577122|NCT03635099|183042084|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
91577123|NCT03635099|183042084|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
91577124|NCT03635099|183042084|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
91577125|NCT03635099|183042084|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
91577126|NCT03635099|183042084|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
91577127|NCT03635099|183042084|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
91577128|NCT03635099|183042084|OTHER||Risk Difference (RD)|25.0||||0.0143|TWO_SIDED|95.0|11.6|38.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||38.4|11.6|0.0143
91577129|NCT03635099|183042084|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
91577130|NCT03635099|183042084|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
91577131|NCT03635099|183042084|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
91577132|NCT03635099|183042085|OTHER||Adjusted mean|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7008|TWO_SIDED|95.0|-1.9|2.8|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||2.8|-1.9|0.7008
91577133|NCT03635099|183042085|OTHER||Adjusted mean|0.6|STANDARD_ERROR_OF_MEAN|1.2||0.6268|TWO_SIDED|95.0|-1.8|3.0|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||3.0|-1.8|0.6268
91577134|NCT03635099|183042085|OTHER||Adjusted mean|2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0266|TWO_SIDED|95.0|0.3|5.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.1|0.3|0.0266
91577135|NCT03635099|183042085|OTHER||Adjusted mean|4.0|STANDARD_ERROR_OF_MEAN|1.2||0.0009|TWO_SIDED|95.0|1.7|6.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||6.3|1.7|0.0009
91577136|NCT03635099|183042085|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
91577137|NCT03635099|183042085|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
91577138|NCT03635099|183042086|OTHER||Risk Difference (RD)|2.5||||0.7144|TWO_SIDED|95.0|-10.1|15.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.1|-10.1|0.7144
91577139|NCT03635099|183042086|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
91577140|NCT03635099|183042086|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
91577141|NCT03635099|183042086|OTHER||Risk Difference (RD)|15.0||||0.125|TWO_SIDED|95.0|-0.6|30.6|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||30.6|-0.6|0.1250
91577142|NCT03635099|183042086|OTHER||Risk Difference (RD)|7.9|||||TWO_SIDED|95.0|-20.3|36.1|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.1|-20.3|
91577143|NCT03635099|183042086|OTHER||Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-21.9|34.3|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||34.3|-21.9|
91577144|NCT05292586|183042119|SUPERIORITY||Adjusted mean difference|0.104|||<|0.001|TWO_SIDED|95.0|0.061|0.148|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.148|0.061|<0.001
91577145|NCT05292586|183042120|SUPERIORITY||Adjusted mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.076|0.173|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.173|0.076|<0.001
91577146|NCT05292586|183042121|SUPERIORITY||Adjusted mean difference|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.139|0.063|<0.001
91577147|NCT05292586|183042122|SUPERIORITY||Adjusted mean difference|0.113|||<|0.001|TWO_SIDED|95.0|0.071|0.154|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.154|0.071|<0.001
91577148|NCT05292586|183042123|SUPERIORITY||Adjusted mean difference|0.069||||0.003|TWO_SIDED|95.0|0.023|0.115|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.115|0.023|0.003
91577149|NCT05292586|183042124|SUPERIORITY||Adjusted mean difference|0.044||||0.05|TWO_SIDED|95.0|0.0|0.088|||ANCOVA|||"1\_Change from baseline -- Week 4~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.088|0.000|0.050
91577150|NCT05292586|183042124|SUPERIORITY||Adjusted mean difference|0.041||||0.098|TWO_SIDED|95.0|-0.007|0.089|||ANCOVA|||"2\_Change from baseline -- Week 8~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.089|-0.007|0.098
91577151|NCT05292586|183042124|SUPERIORITY||Adjusted mean difference|0.043||||0.056|TWO_SIDED|95.0|-0.001|0.086|||ANCOVA|||"3\_Change from baseline -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.086|-0.001|0.056
91577152|NCT05292586|183042125|SUPERIORITY||Odds Ratio (OR)|1.327||||0.098|TWO_SIDED|95.0|0.949|1.855|||Logistic regression model|||1\_Responders at Week 4||1.855|0.949|0.098
91577153|NCT05292586|183042125|SUPERIORITY||Odds Ratio (OR)|1.262||||0.18|TWO_SIDED|95.0|0.898|1.772|||Logistic regression model|||2\_Responders at Week 8||1.772|0.898|0.180
91577154|NCT05292586|183042125|SUPERIORITY||Odds Ratio (OR)|1.568||||0.009|TWO_SIDED|95.0|1.117|2.203|||Logistic regression model|||3\_Responders at Week 12||2.203|1.117|0.009
91577155|NCT05292586|183042126|SUPERIORITY||Odds Ratio (OR)|1.822|||<|0.001|TWO_SIDED|95.0|1.284|2.587|||Logistic regression model|||1\_Responders at Week 12||2.587|1.284|<0.001
91577156|NCT05292586|183042127|SUPERIORITY||Adjusted mean difference|8.78||||0.002|TWO_SIDED|95.0|3.3|14.27|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.27|3.30|0.002
91577157|NCT05292586|183042128|SUPERIORITY||Adjusted mean difference|8.73||||0.002|TWO_SIDED|95.0|3.32|14.14|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.14|3.32|0.002
91577158|NCT05292586|183042129|SUPERIORITY||Adjusted mean difference|-0.112||||0.026|TWO_SIDED|95.0|-0.211|-0.013|||ANCOVA|||"1\_Change From Baseline in ACQ-7 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||-0.013|-0.211|0.026
91577159|NCT05292586|183042129|SUPERIORITY||Adjusted mean difference|0.02||||0.686|TWO_SIDED|95.0|-0.077|0.118|||ANCOVA|||"2\_Change from baseline in ACQ-5 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.118|-0.077|0.686
91577160|NCT05292586|183042130|SUPERIORITY||Adjusted mean difference|3.82||||0.033|TWO_SIDED|95.0|0.31|7.33|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.330|0.310|0.033
91577161|NCT05292586|183042131|SUPERIORITY||Adjusted mean difference|3.78||||0.078|TWO_SIDED|95.0|-0.425|7.985|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.985|-0.425|0.078
91577162|NCT02367040|183042138|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.52||||2e-06|TWO_SIDED|95.0|0.393|0.688||1-sided p-value|Log Rank|||At primary completion date||0.688|0.393|0.000002
91577163|NCT02367040|183042138|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.557||||3e-06|TWO_SIDED|95.0|0.431|0.722||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.722|0.431|0.000003
91577164|NCT02367040|183042138|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.643||||0.000199|TWO_SIDED|95.0|0.502|0.823||1-sided p-value|Log Rank|||At final analysis||0.823|0.502|0.000199
91577165|NCT02367040|183042139|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|32.99|||<|1e-06|TWO_SIDED|95.0|23.95|42.03||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||42.03|23.95|<0.000001
91577166|NCT02367040|183042139|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|30.67|||<|1e-06|TWO_SIDED|95.0|21.63|39.72||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||39.72|21.63|<0.000001
91577167|NCT02367040|183042140|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|19.27|||<|1e-06|TWO_SIDED|95.0|11.57|26.96||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||26.96|11.57|<0.000001
91577168|NCT02367040|183042140|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|18.92||||1e-06|TWO_SIDED|95.0|11.11|26.73||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||26.73|11.11|0.000001
91577169|NCT02367040|183042141|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Kaplan-Meier estimates|0.7||||0.030371|TWO_SIDED|95.0|0.481|1.018||1-sided p-value|Log Rank|||At primary completion date||1.018|0.481|0.030371
91577170|NCT02367040|183042141|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.761||||0.051976|TWO_SIDED|95.0|0.547|1.059||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.059|0.547|0.051976
91577171|NCT02367040|183042142|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||11.12|-2.26|0.097339
91577172|NCT02367040|183042142|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||11.12|-2.26|0.097339
91577173|NCT02367040|183042143|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.476|||<|1e-06|TWO_SIDED|95.0|0.357|0.635||1-sided p-value|Log Rank|||At primary completion date||0.635|0.357|<.000001
91577174|NCT02367040|183042143|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.505|||<|1e-06|TWO_SIDED|95.0|0.387|0.659||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.659|0.387|<.000001
91577175|NCT02367040|183042144|SUPERIORITY|OS was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.972||||0.436458|TWO_SIDED|95.0|0.691|1.368||1-sided p-value|Log Rank|||||1.368|0.691|0.436458
91577176|NCT02367040|183042145|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.06||||0.69261|TWO_SIDED|95.0|0.843|1.331||1-sided p-value|Log Rank|||At primary completion date||1.331|0.843|0.692610
91577177|NCT02367040|183042145|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.047||||0.661145|TWO_SIDED|95.0|0.841|1.302||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.302|0.841|0.661145
91577178|NCT02367040|183042146|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.996||||0.510038|TWO_SIDED|95.0|0.732|1.355||1-sided p-value|Log Rank|||At primary completion date||1.355|0.732|0.510038
91577179|NCT02367040|183042146|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.036||||0.40597|TWO_SIDED|95.0|0.768|1.398||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.398|0.768|0.405970
91577180|NCT02477618|183042150|SUPERIORITY||Odds Ratio (OR)|1.056||||0.878|TWO_SIDED|95.0|0.527|2.118|||Regression, Logistic|||||2.118|0.527|0.878
91577181|NCT02477618|183042151|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.636|TWO_SIDED|95.0|0.222|2.507|||Regression, Cox|||||2.507|0.222|0.636
91577182|NCT02477618|183042152|SUPERIORITY||Odds Ratio (OR)|0.623||||0.199|TWO_SIDED|95.0|0.303|1.282|||Regression, Logistic|||||1.282|0.303|0.199
91577183|NCT02477618|183042153|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.328|TWO_SIDED|95.0|0.318|1.466|||Regression, Cox|||||1.466|0.318|0.328
91577184|NCT02477618|183042155|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.339|TWO_SIDED|95.0|0.193|1.763|||Regression, Cox|||||1.763|0.193|0.339
91577185|NCT02477618|183042156|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.817|TWO_SIDED|95.0|0.539|2.189|||Regression, Cox|||||2.189|0.539|0.817
91577186|NCT02477618|183042157|SUPERIORITY||LS Mean Difference|-0.2||||0.567|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.567
91577187|NCT02284009|183042179|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|0.0|0.24|||||Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide - Placebo) \>= 0.2 nmol/L = 0.097.|||0.24|0.00|
91577188|NCT03841526|183042212|OTHER|Parameters that did not meet normality criterion were analyzed non-parametrically. Overall treatment effect was assessed using Friedman's test.||||||0.0002|||||||ANOVA|||The primary efficacy analysis was analyzed by analysis of variance (ANOVA) comparing the mean incidence rates among the 3 treatment groups in the Outpatient Phase. If the performed Friedman's test yielded an overall p-value less than 0.05, post-hoc analysis of groups means were conducted to statistically determine which group means differed.||||0.0002
91577189|NCT03841526|183042212|OTHER||||||<|0.0001|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||<0.0001
91577190|NCT03841526|183042212|OTHER|||||||0.0032|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.0032
91577191|NCT03841526|183042212|OTHER|||||||0.2072|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.2072
91577192|NCT03841526|183042215|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91577193|NCT03841526|183042216|OTHER|||||||0.859|||||||Chi-squared|||||||0.8590
91577194|NCT07025837|183042238|SUPERIORITY||||||>|0.9999||||||Week 2 compared to the baseline.|ANOVA|||||||>0.9999
91577195|NCT07025837|183042238|SUPERIORITY||||||>|0.9999||||||Week 4 compared to baseline.|ANOVA|||||||>0.9999
91577196|NCT07025837|183042238|SUPERIORITY|||||||0.6342||||||Week 6 compared to baseline.|ANOVA|||||||0.6342
91577197|NCT07025837|183042238|SUPERIORITY|||||||0.0231||||||Week 8 compared to baseline.|ANOVA|||||||0.0231
91577198|NCT07025837|183042238|SUPERIORITY|||||||0.0862||||||Week 10 compared to baseline.|ANOVA|||||||0.0862
91577199|NCT07025837|183042238|SUPERIORITY|||||||0.0033||||||Week 12 compared to baseline.|ANOVA|||||||0.0033
91577200|NCT07025837|183042239|SUPERIORITY|||||||0.1176||||||Week 2 compared to baseline|ANOVA|||||||0.1176
91577201|NCT07025837|183042239|SUPERIORITY|||||||0.003||||||Week 4 compared to baseline.|ANOVA|||||||0.0030
91577202|NCT07025837|183042239|SUPERIORITY|||||||0.0001||||||Week 6 compared to baseline.|ANOVA|||||||0.0001
91577203|NCT07025837|183042239|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577204|NCT07025837|183042239|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577205|NCT07025837|183042240|SUPERIORITY|||||||0.9751||||||Week 2 compared to baseline.|ANOVA|||||||0.9751
91577206|NCT07025837|183042240|SUPERIORITY|||||||0.0078||||||Week 4 compared to baseline.|ANOVA|||||||0.0078
91577207|NCT07025837|183042240|SUPERIORITY|||||||0.0003||||||Week 6 compared to baseline.|ANOVA|||||||0.0003
91577208|NCT07025837|183042240|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577209|NCT07025837|183042240|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577210|NCT07025837|183042240|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577211|NCT07025837|183042241|SUPERIORITY|||||||0.0544||||||Week 2 compared to baseline.|ANOVA|||||||0.0544
91577212|NCT07025837|183042241|SUPERIORITY|||||||0.0036||||||Week 4 compared to baseline.|ANOVA|||||||0.0036
91577213|NCT07025837|183042241|SUPERIORITY|||||||0.0001||||||Week 6 compared to baseline.|ANOVA|||||||0.0001
91577214|NCT07025837|183042241|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577215|NCT07025837|183042241|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577216|NCT07025837|183042241|SUPERIORITY||||||<|0.0001||||||Week 12 compared to Baseline|ANOVA|||||||<0.0001
91577217|NCT07025837|183042242|SUPERIORITY|||||||0.0001||||||Week 2 compared to baseline.|ANOVA|||||||0.0001
91577218|NCT07025837|183042242|SUPERIORITY||||||<|0.0001||||||Week 4 compared to baseline.|ANOVA|||||||<0.0001
91577219|NCT07025837|183042242|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
91577220|NCT07025837|183042242|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577221|NCT07025837|183042242|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577222|NCT07025837|183042242|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577223|NCT07025837|183042243|SUPERIORITY|||||||0.1438||||||Week 2 compared to baseline.|ANOVA|||||||0.1438
91577224|NCT07025837|183042243|SUPERIORITY|||||||0.0092||||||Week 4 compared to baseline.|ANOVA|||||||0.0092
91577225|NCT07025837|183042243|SUPERIORITY|||||||0.0003||||||Week 6 compared to baseline.|ANOVA|||||||0.0003
91577226|NCT07025837|183042243|SUPERIORITY|||||||0.0015||||||Week 8 compared to baseline.|ANOVA|||||||0.0015
91577227|NCT07025837|183042243|SUPERIORITY|||||||0.0001||||||Week 10 compared to baseline.|ANOVA|||||||0.0001
91577228|NCT07025837|183042243|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577229|NCT07025837|183042244|SUPERIORITY|||||||0.0041||||||Week 2 compared to baseline.|ANOVA|||||||0.0041
91577230|NCT07025837|183042244|SUPERIORITY|||||||0.0001||||||Week 4 compared to baseline.|ANOVA|||||||0.0001
91577231|NCT07025837|183042244|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
91577232|NCT07025837|183042244|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577233|NCT07025837|183042244|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577234|NCT07025837|183042244|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577235|NCT07025837|183042245|SUPERIORITY|||||||0.0249||||||Week 2 compared to baseline.|ANOVA|||||||0.0249
91577236|NCT07025837|183042245|SUPERIORITY||||||<|0.0001||||||Week 4 compared to baseline.|ANOVA|||||||<0.0001
91577237|NCT07025837|183042245|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
91577238|NCT07025837|183042245|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577239|NCT07025837|183042245|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577240|NCT07025837|183042245|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577241|NCT07025837|183042246|SUPERIORITY||||||>|0.9999||||||Week 2 compared to baseline.|ANOVA|||||||>0.9999
91577242|NCT07025837|183042246|SUPERIORITY|||||||0.7453||||||Week 4 compared to baseline|ANOVA|||||||0.7453
91577243|NCT07025837|183042246|SUPERIORITY|||||||0.2118||||||Week 6 compared to baseline.|ANOVA|||||||0.2118
91577244|NCT07025837|183042246|SUPERIORITY|||||||0.0111||||||Week 8 compared to baseline.|ANOVA|||||||0.0111
91577245|NCT07025837|183042246|SUPERIORITY|||||||0.015||||||Week 10 compared to baseline.|ANOVA|||||||0.0150
91577246|NCT07025837|183042246|SUPERIORITY|||||||0.0003||||||Week 12 compared to baseline.|ANOVA|||||||0.0003
91577247|NCT07025837|183042247|SUPERIORITY|||||||0.0199||||||Week 2 compared to baseline.|ANOVA|||||||0.0199
91577248|NCT07025837|183042247|SUPERIORITY||||||<|0.0001||||||Week 4 compared to baseline.|ANOVA|||||||<0.0001
91577249|NCT07025837|183042247|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
91577250|NCT07025837|183042247|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577251|NCT07025837|183042247|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline|ANOVA|||||||<0.0001
91577252|NCT07025837|183042247|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577253|NCT07025837|183042248|SUPERIORITY|||||||0.4438||||||Week 2 compared to baseline.|ANOVA|||||||0.4438
91577254|NCT07025837|183042248|SUPERIORITY|||||||0.0412||||||Week 4 compared to baseline.|ANOVA|||||||0.0412
91577255|NCT07025837|183042248|SUPERIORITY|||||||0.0943||||||Week 6 compared to baseline|ANOVA|||||||0.0943
91577256|NCT07025837|183042248|SUPERIORITY|||||||0.0017||||||Week 8 compared to baseline.|ANOVA|||||||0.0017
91577257|NCT07025837|183042248|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577258|NCT07025837|183042248|SUPERIORITY|||||||0.0007||||||Week 12 compared to baseline.|ANOVA|||||||0.0007
91577259|NCT07025837|183042249|SUPERIORITY|||||||0.6148||||||Week 2 compared to baseline.|ANOVA|||||||0.6148
91577260|NCT07025837|183042249|SUPERIORITY|||||||0.7953||||||Week 4 compared to baseline.|ANOVA|||||||0.7953
91577261|NCT07025837|183042249|SUPERIORITY|||||||0.0019||||||Week 6 compared to baseline.|ANOVA|||||||0.0019
91577262|NCT07025837|183042249|SUPERIORITY|||||||0.0008||||||Week 8 compared to baseline.|ANOVA|||||||0.0008
91577263|NCT07025837|183042249|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577264|NCT07025837|183042249|SUPERIORITY|||||||0.0002||||||Week 12 compared to baseline.|ANOVA|||||||0.0002
91577265|NCT07025837|183042250|SUPERIORITY|||||||0.0067||||||Week 2 compared to baseline.|ANOVA|||||||0.0067
91577266|NCT07025837|183042250|SUPERIORITY|||||||0.0055||||||Week 4 compared to baseline.|ANOVA|||||||0.0055
91577267|NCT07025837|183042250|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
91577268|NCT07025837|183042250|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577269|NCT07025837|183042250|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577270|NCT07025837|183042250|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577271|NCT07025837|183042251|SUPERIORITY|||||||0.1476||||||Week 2 compared to baseline.|ANOVA|||||||0.1476
91577272|NCT07025837|183042251|SUPERIORITY|||||||0.0106||||||Week 4 compared to baseline.|ANOVA|||||||0.0106
91577273|NCT07025837|183042251|SUPERIORITY|||||||0.0002||||||Week 6 compared to baseline.|ANOVA|||||||0.0002
91577274|NCT07025837|183042251|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline|ANOVA|||||||<0.0001
91577275|NCT07025837|183042251|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577276|NCT07025837|183042251|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577277|NCT07025837|183042252|SUPERIORITY|||||||0.3224||||||Week 2 compared to baseline.|ANOVA|||||||0.3224
91577278|NCT07025837|183042252|SUPERIORITY|||||||0.0426||||||Week 4 compared to baseline.|ANOVA|||||||0.0426
91577279|NCT07025837|183042252|SUPERIORITY|||||||0.0039||||||Week 6 compared to baseline.|ANOVA|||||||0.0039
91577280|NCT07025837|183042252|SUPERIORITY|||||||0.004||||||Week 8 compared to baseline.|ANOVA|||||||0.0040
91577281|NCT07025837|183042252|SUPERIORITY|||||||0.0013||||||Week 10 compared to baseline.|ANOVA|||||||0.0013
91577282|NCT07025837|183042252|SUPERIORITY|||||||0.0005||||||Week 12 compared to baseline.|ANOVA|||||||0.0005
91577283|NCT07025837|183042253|SUPERIORITY|||||||0.3032||||||Week 2 compared to baseline.|ANOVA|||||||0.3032
91577284|NCT07025837|183042253|SUPERIORITY|||||||0.0237||||||Week 4 compared to baseline.|ANOVA|||||||0.0237
91577285|NCT07025837|183042253|SUPERIORITY|||||||0.001||||||Week 6 compared to baseline.|ANOVA|||||||0.0010
91577286|NCT07025837|183042253|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577287|NCT07025837|183042253|SUPERIORITY|||||||0.0002||||||Week 10 compared to baseline.|ANOVA|||||||0.0002
91577288|NCT07025837|183042253|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577289|NCT07025837|183042254|SUPERIORITY||||||>|0.9999||||||Week 2 compared to baseline.|ANOVA|||||||>0.9999
91577290|NCT07025837|183042254|SUPERIORITY|||||||0.1147||||||Week 4 compared to baseline|ANOVA|||||||0.1147
91577291|NCT07025837|183042254|SUPERIORITY|||||||0.0016||||||Week 6 compared to baseline.|ANOVA|||||||0.0016
91577292|NCT07025837|183042254|SUPERIORITY|||||||0.0048||||||Week 8 compared to baseline.|ANOVA|||||||0.0048
91577293|NCT07025837|183042254|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577294|NCT07025837|183042254|SUPERIORITY|||||||0.0005||||||Week 12 compared to baseline.|ANOVA|||||||0.0005
91577295|NCT07025837|183042255|SUPERIORITY|||||||0.0461||||||Week 2 compared to baseline.|ANOVA|||||||0.0461
91577296|NCT07025837|183042255|SUPERIORITY|||||||0.002||||||Week 4 compared to baseline.|ANOVA|||||||0.002
91577297|NCT07025837|183042255|SUPERIORITY|||||||0.0002||||||Week 6 compared to baseline.|ANOVA|||||||0.0002
91577298|NCT07025837|183042255|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
91577299|NCT07025837|183042255|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
91577300|NCT07025837|183042255|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
91577301|NCT01424813|183042278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.128|<|0.0001|TWO_SIDED|95.0|0.57|1.08||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.08|0.57|<0.0001
91577302|NCT01424813|183042279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|0.68|1.46||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.46|0.68|<0.0001
91577303|NCT01424813|183042294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|0.41|1.06||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.06|0.41|<0.0001
91577304|NCT01424813|183042295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|0.38|0.99||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||0.99|0.38|<0.0001
91577305|NCT00515671|183042315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8868|TWO_SIDED||||||Mixed Models Analysis|||||||.8868
91577306|NCT00515671|183042316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3328|TWO_SIDED||||||Mixed Models Analysis|||||||.3328
91577307|NCT02683772|183042332|NON_INFERIORITY|The method proposed for this analysis was a one-sided paired t-test using a significance level of 0.05 and a non-inferiority margin of 2 events/hour|Mean Difference (Final Values)|-4.45|STANDARD_DEVIATION|17.23||0.0134|TWO_SIDED||||||t-test, 1 sided|||||||0.0134
91577308|NCT01498887|183042340|SUPERIORITY_OR_OTHER|||||||0.3118|||||||Wilcoxon (Mann-Whitney)|||||||0.3118
91577309|NCT02993406|183042347|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.004|TWO_SIDED|95.0|0.79|0.96|||Log Rank|||||0.96|0.79|0.004
91577310|NCT02993406|183042348|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0058|TWO_SIDED|95.0|0.76|0.96|||Log Rank|||||0.96|0.76|0.0058
91577311|NCT02993406|183042349|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0016|TWO_SIDED|95.0|0.66|0.91|||Log Rank|||||0.91|0.66|0.0016
91577312|NCT02993406|183042350|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0013|TWO_SIDED|95.0|0.72|0.92|||Log Rank|||||0.92|0.72|0.0013
91577313|NCT02993406|183042351|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1593|TWO_SIDED|95.0|0.67|1.07|||Log Rank|||||1.07|0.67|0.1593
91577314|NCT02993406|183042352|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6227|TWO_SIDED|95.0|0.88|1.24|||Log Rank|||||1.24|0.88|0.6227
91577315|NCT02993406|183042353|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6608|TWO_SIDED|95.0|0.9|1.18|||Log Rank|||||1.18|0.90|0.6608
91577316|NCT04325282|183042361|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after active rTMS (post-rTMS compared to pre-rTMS).||||0.04
91577317|NCT04325282|183042361|OTHER|||||||0.46||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after sham rTMS (post-rTMS compared to pre-rTMS).||||0.46
91577318|NCT04325282|183042361|OTHER|||||||0.12||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Between-group analysis of change induced by active rTMS versus sham rTMS||||0.12
91577319|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed-rank test|||Within-group analysis of change in cF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
91577320|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
91577321|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iT connectivity induced by active versus sham rTMS.||||<0.0001
91577322|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
91577323|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.43||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.43
91577324|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-iT connectivity induced by active versus sham rTMS.||||<0.0001
91577325|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
91577326|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.54||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.54
91577327|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.007||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cM connectivity induced by active versus sham rTMS.||||0.007
91577328|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
91577329|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.32||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.32
91577330|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iT connectivity induced by active versus sham rTMS.||||0.01
91577331|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
91577332|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.29||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.29
91577333|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cF connectivity induced by active versus sham rTMS.||||0.02
91577334|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
91577335|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.66||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.66
91577336|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.008||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cT connectivity induced by active versus sham rTMS.||||0.008
91577337|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.005||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.005
91577338|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.87||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.87
91577339|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.11||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cT connectivity induced by active versus sham rTMS.||||0.11
91577340|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.012||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.012
91577341|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.46||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.46
91577342|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iM connectivity induced by active versus sham rTMS.||||0.02
91577343|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
91577344|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.99||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.99
91577345|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iT-cT connectivity induced by active versus sham rTMS.||||0.04
91577346|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
91577347|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.31||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.31
91577348|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cT connectivity induced by active versus sham rTMS.||||0.05
91577349|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.03|||||||Wilcoxon signed rank test|The threshold for statistical significance was p \< 0.0076.||Within-group analysis of change in cF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.03
91577350|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.2||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.20
91577351|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cM connectivity induced by active versus sham rTMS.||||0.04
91577352|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.05
91577353|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.59||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.59
91577354|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iM connectivity induced by active versus sham rTMS.||||0.12
91577355|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.1||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.10
91577356|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.57||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.57
91577357|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.06||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-iT connectivity induced by active versus sham rTMS.||||0.06
91577358|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
91577359|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
91577360|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.14||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-cT connectivity induced by active versus sham rTMS.||||0.14
91577361|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
91577362|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.6||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.60
91577363|NCT04325282|183042362|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cM connectivity induced by active versus sham rTMS.||||0.04
91577364|NCT04020185|183042377|OTHER||maximum tolerated dose (monotherapy)|1200.0|||||TWO_SIDED|||||||||||||
91577365|NCT00527787|183042382|SUPERIORITY_OR_OTHER||proportions|4.1||||0.001|TWO_SIDED|95.0|1.9|7.7|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||7.7|1.9|0.001
91577366|NCT00527787|183042383|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91577367|NCT00527787|183042384|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91577368|NCT00527787|183042385|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|||||||0.003
91577369|NCT00527787|183042386|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91577370|NCT02783027|183042391|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|Two sample t-test on the change in sleep quality from baseline to 4 months.||||||0.76
91577371|NCT02783027|183042392|SUPERIORITY||||||<|0.0001||||||Test for group\*time interaction.|Mixed Models Analysis|||||||<0.0001
91577372|NCT02783027|183042393|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
91577373|NCT02783027|183042394|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
91577374|NCT02783027|183042395|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|Two sample t-test for change in Occupational Fatigue Exhaustion Recovery (OFER) inter-shift recovery between groups||||||0.91
91577375|NCT02175641|183042472|OTHER|Generalized linear mixed-effects models with a logistic link|Odds Ratio (OR)|1.07|||>|0.05|TWO_SIDED|95.0|0.62|1.84|||Regression, Logistic|||||1.84|0.62|>0.05
91577376|NCT02175641|183042473|OTHER|Mixed effect models controlling for study site.|Time by treatment interaction coefficien|0.15|STANDARD_ERROR_OF_MEAN|0.59||0.804|TWO_SIDED||||||Mixed Models Analysis|||||||0.804
91577377|NCT02175641|183042474|OTHER||Time*treatment interaction coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
91577378|NCT02175641|183042475|OTHER|Mixed effect models controlling for study site.|time*treatment interaction coefficient|-0.34|STANDARD_ERROR_OF_MEAN|0.74||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
91577379|NCT02175641|183042476|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
91577380|NCT02175641|183042477|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
91577381|NCT02175641|183042478|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.37||0.52|TWO_SIDED||||||Mixed Models Analysis|||||||0.52
91577382|NCT02175641|183042479|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|3.83|STANDARD_ERROR_OF_MEAN|3.28||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
91577383|NCT03031496|183042513|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|91.52|||||TWO_SIDED|90.0|87.77|95.43|||||Comparison of AUC (0-t) of hydrochlorothiazide for test and reference product has been presented.|||95.43|87.77|
91577384|NCT03031496|183042513|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|102.42|||||TWO_SIDED|90.0|98.12|106.91|||||Comparison of AUC (0-t) of amiloride for test and reference product has been presented.|||106.91|98.12|
91577385|NCT03031496|183042514|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|82.86|||||TWO_SIDED|90.0|77.37|88.74|||||Comparison of Cmax of hydrochlorothiazide for test and reference product has been presented.|||88.74|77.37|
91577386|NCT03031496|183042514|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|103.92|||||TWO_SIDED|90.0|97.42|110.86|||||Comparison of Cmax of amiloride for test and reference product has been presented.|||110.86|97.42|
91514172|NCT04079933|182900463|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL|Mean Difference (Net)|-12.2||||0.8264|TWO_SIDED|95.0|-122.0|97.5|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL||97.5|-122|0.8264
91577387|NCT03031496|183042515|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|92.37|||||TWO_SIDED|90.0|88.75|96.12|||||Comparison of Tmax of hydrochlorothiazide for test and reference product has been presented.|||96.12|88.75|
91577388|NCT03031496|183042515|OTHER||Least square mean ratio|101.47|||||TWO_SIDED|90.0|97.84|105.23|||||Comparison of Tmax of amiloride for test and reference product has been presented.|||105.23|97.84|
91577389|NCT01399697|183042534|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANCOVA|||||||0.700
91577390|NCT01399697|183042535|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Chi-squared|||||||0.328
91577391|NCT01399697|183042536|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Chi-squared|||||||0.518
91577392|NCT01399697|183042537|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||Chi-squared|||||||0.358
91577393|NCT01399697|183042538|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|0.032||||0.674|TWO_SIDED|95.0|-0.119|0.184|||ANCOVA||Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.|||0.184|-0.119|0.674
91577394|NCT01399697|183042539|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.873||||0.204|TWO_SIDED|95.0|-4.775|1.03|||ANCOVA||ANCOVA model with treatment as factor and mental component score (MCS) as covariate.|||1.030|-4.775|0.204
91577395|NCT01399697|183042540|SUPERIORITY_OR_OTHER||Difference in LS Mean|3.376||||0.015|TWO_SIDED|95.0|0.676|6.076|||ANCOVA||ANCOVA model with treatment as factor and physical component score (PCS) as covariate.|||6.076|0.676|0.015
91577396|NCT01399697|183042541|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.969||||0.769|TWO_SIDED|95.0|-5.526|7.464|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.|||7.464|-5.526|0.769
91577397|NCT01399697|183042542|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.216||||0.655|TWO_SIDED|95.0|-6.573|4.141|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.|||4.141|-6.573|0.655
91577398|NCT01712061|183042557|SUPERIORITY_OR_OTHER||Ratio of geometric mean changes|0.92|||||TWO_SIDED|95.0|0.75|1.09|||ANCOVA|Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).||||1.09|0.75|
91577399|NCT00504777|183042579|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91577400|NCT00504777|183042582|SUPERIORITY_OR_OTHER|||||||0.0054|||||||t-test, 2 sided|||||||0.0054
91577401|NCT01572740|183042594|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.3|||<|0.0001||95.0|-1.47|-1.13|||ANCOVA|||||-1.13|-1.47|<0.0001
91577402|NCT01572740|183042595|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.81|||<|0.0001||95.0|-0.99|-0.63|||ANCOVA|||||-0.63|-0.99|<0.0001
91577403|NCT01572740|183042596|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.83|||<|0.0006||95.0|-1.3|-0.36|||ANCOVA|||||-0.36|-1.30|<0.0006
91577404|NCT01572740|183042597|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.26||||0.2511||95.0|-0.7|0.18|||ANCOVA|||||0.18|-0.70|0.2511
91577405|NCT01572740|183042598|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.87|||<|0.0001||95.0|-2.37|-1.38|||ANCOVA|||||-1.38|-2.37|<0.0001
91577406|NCT01572740|183042599|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.28|||<|0.0001||95.0|-1.73|-0.83|||ANCOVA|||||-0.83|-1.73|<0.0001
91577407|NCT01572740|183042600|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.73||||0.0023||95.0|-1.2|-0.26|||ANCOVA|||||-0.26|-1.20|0.0023
91577408|NCT01572740|183042601|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.39||||0.1787||95.0|-0.97|0.18|||ANCOVA|||||0.18|-0.97|0.1787
91577409|NCT01572740|183042602|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.14||||0.4806||95.0|-0.54|0.25|||ANCOVA|||||0.25|-0.54|0.4806
91577410|NCT01572740|183042603|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.35||||0.2074||95.0|-0.91|0.2|||ANCOVA|||||0.20|-0.91|0.2074
91577411|NCT01401153|183042606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation based on parallel group design --\> revealed that 68 children are needed to detect a difference of 45ms in the mean reaction time between the groups, with α=.05 and a power of 0.8.||||||0.79|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||Power calculation had been performed.||||0.79
91577412|NCT01401153|183042607|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.07|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.07
91577413|NCT01401153|183042608|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.61|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.61
91577414|NCT01401153|183042609|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been perfomed based on this measure||||||0.03|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.03
91577415|NCT01401153|183042610|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.25|||||||Generalized linear models|The fixed statement considered treatment, test day and the interaction between treatment and test day||||||0.25
91577416|NCT01401153|183042611|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.7|||||||Generalized linear models|||||||0.70
91577417|NCT01401153|183042612|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.33|||||||Generalized linear models|||||||0.33
91577418|NCT01401153|183042613|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.63|||||||Generalized linear models|||||||0.63
91577419|NCT01401153|183042614|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.62|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.62
91577420|NCT01401153|183042615|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.11|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.11
91577421|NCT01401153|183042616|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.45|||||||t-test, 2 sided|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.45
91577422|NCT01401153|183042617|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.13
91577423|NCT01401153|183042618|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.68|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.68
91577424|NCT01401153|183042619|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.67|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.67
91577425|NCT04662060|183042690|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
91577426|NCT04662060|183042691|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
91577427|NCT04662060|183042693|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
91577428|NCT04662060|183042694|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
91577429|NCT04662060|183042695|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
91577430|NCT05140915|183042698|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||.77
91577431|NCT03238963|183042762|OTHER||Risk Difference (RD)|0.057|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|-0.053|0.192|||Chan and Zhang method|95% confidence interval was calculating using the Chan and Zhang method.|Risk difference of BI 1467335 10 milligram (mg) group minus Placebo group.|||0.192|-0.053|
91577432|NCT05718466|183042768|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
91577433|NCT05718466|183042769|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
91577434|NCT01882543|183042770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.061|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||A sample size of 28 subjects per group had 80% power to detect a 1.5-point difference in the change from baseline pain score between AQX-1125 and placebo assuming a between-subject SD of 2.0 and a 2-sided 5% significance level. Average daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the primary efficacy end point of average daily pain score||0.0|-2.1|0.061
91577435|NCT01882543|183042771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.03|TWO_SIDED|95.0|-2.5|-0.1|||ANCOVA|||E-diary maximum daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the secondary efficacy variable of maximum daily pain score||-0.1|-2.5|0.030
91577436|NCT01882543|183042772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.008|TWO_SIDED|95.0|-2.8|-0.5|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-2.8|0.008
91577437|NCT01882543|183042773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.028|TWO_SIDED|95.0|-3.0|-0.2|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.2|-3.0|0.028
91577438|NCT01882543|183042774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.011|TWO_SIDED|95.0|-9.5|-1.3|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.3|-9.5|0.011
91577439|NCT01882543|183042775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.007|TWO_SIDED|95.0|-8.8|-1.4||ICSI/PI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.4|-8.8|0.007
91577440|NCT01882543|183042775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.005|TWO_SIDED|95.0|-4.6|-0.9||ICSI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.9|-4.6|0.005
91577441|NCT01882543|183042775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.014|TWO_SIDED|95.0|-4.5|-0.5||ICPI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-4.5|0.014
91577442|NCT01882543|183042776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.592|TWO_SIDED|95.0|-6.3|3.6||Mental Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||3.6|-6.3|0.592
91577443|NCT01882543|183042776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.221|TWO_SIDED|95.0|-1.6|6.7||Physical Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||6.7|-1.6|0.221
91577444|NCT01882543|183042777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.04|TWO_SIDED|95.0|-5.5|-0.1|||ANOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.1|-5.5|0.040
91577445|NCT01253135|183042779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.7||0.3393|TWO_SIDED|95.0|-3.08|0.84|||Prentice-Wilcoxon test||The Confidence Interval was based on a t-distribution|||0.84|-3.08|.3393
91577446|NCT01253135|183042780|SUPERIORITY_OR_OTHER|||||||0.4771|TWO_SIDED||||||Log Rank|Testing was by a Log Rank test with significance being at P \< 0.05||||||.4771
91577447|NCT00264303|183042829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.005||95.0|0.08|0.43|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.||||0.43|0.08|0.005
91577448|NCT00264303|183042830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.041||95.0|0.01|0.34|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate||||0.34|0.01|0.041
91577449|NCT00264303|183042831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.004||95.0|0.04|0.22|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.||||0.22|0.04|0.004
91577450|NCT00264303|183042832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.002||95.0|0.06|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.||||0.26|0.06|0.002
91577451|NCT00264303|183042833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.009||95.0|0.03|0.22|||ANCOVA|ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.||||0.22|0.03|0.009
91577452|NCT00264303|183042834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|||<|0.001||95.0|0.07|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline severity as covariate.||The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg||0.26|0.07|<0.001
91577453|NCT02815579|183042835|SUPERIORITY||Difference in log odds|-0.08||||0.86|TWO_SIDED|95.0|-1.0|0.84|||Mixed Models Analysis|||The investigators produced a difference-in-difference estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.84|-1.0|0.86
91577454|NCT02815579|183042836|SUPERIORITY||Difference in log odds|0.32||||0.23|TWO_SIDED|95.0|-0.28|0.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.92|-0.28|0.23
91577455|NCT02815579|183042837|SUPERIORITY||Mean Difference (Net)|1.39||||0.26|TWO_SIDED|95.0|-1.01|3.78|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||3.78|-1.01|0.26
91577456|NCT02815579|183042838|SUPERIORITY||Difference in log odds|0.84||||0.31|TWO_SIDED|95.0|-0.79|2.47|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||2.47|-0.79|0.31
91577457|NCT02815579|183042839|SUPERIORITY||Difference in log odds|-0.34||||0.44|TWO_SIDED|95.0|-1.22|0.53|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.53|-1.22|0.44
91577458|NCT02815579|183042840|SUPERIORITY||Mean Difference (Net)|-3.54|||<|0.001|TWO_SIDED|95.0|-4.16|-2.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-2.92|-4.16|<0.001
91577459|NCT02815579|183042841|SUPERIORITY||Mean Difference (Net)|-0.21||||0.02|TWO_SIDED|95.0|-0.39|-0.04|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.04|-0.39|0.02
91577460|NCT02815579|183042842|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|95.0|-0.82|0.84|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||0.84|-0.82|0.98
91577461|NCT02815579|183042843|SUPERIORITY||Mean Difference (Net)|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.15|-0.59|0.001
91577462|NCT02815579|183042844|SUPERIORITY||Difference in log odds|-0.83||||0.001|TWO_SIDED|95.0|-1.45|-0.2|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||-0.20|-1.45|0.001
91577463|NCT02815579|183042845|SUPERIORITY||Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.52|-0.31|||Mixed Models Analysis|||||-0.31|-0.52|<0.001
91577464|NCT02389452|183042846|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
91577465|NCT02311673|183042864|OTHER||Least Squares (LS) Mean Difference|-0.3||||0.42|TWO_SIDED|95.0|-3.1|2.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-3.1|0.420
91577466|NCT02311673|183042864|OTHER||LS Mean Difference|-0.4||||0.348|TWO_SIDED|95.0|-2.3|1.6|||Longitudinal mixed analysis of variance|One sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.348
91577467|NCT02311673|183042864|OTHER||LS Mean Difference|0.8||||0.779|TWO_SIDED|95.0|-1.3|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-1.3|0.779
91577468|NCT02311673|183042866|OTHER||LS Mean Difference|21.5||||0.901|TWO_SIDED|95.0|-11.8|54.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.8|-11.8|0.901
91577469|NCT02311673|183042866|OTHER||LS Mean Difference|-3.9||||0.362|TWO_SIDED|95.0|-26.3|18.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.5|-26.3|0.362
91577470|NCT02311673|183042866|OTHER||LS Mean Difference|-3.7||||0.378|TWO_SIDED|95.0|-28.0|20.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||20.5|-28.0|0.378
91577471|NCT02311673|183042867|OTHER||LS Mean Difference|20.6||||0.84|TWO_SIDED|95.0|-20.9|62.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||62.2|-20.9|0.840
91577472|NCT02311673|183042867|OTHER||LS Mean Difference|-10.2||||0.236|TWO_SIDED|95.0|-38.7|18.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.4|-38.7|0.236
91577473|NCT02311673|183042867|OTHER||LS Mean Difference|-13.4||||0.191|TWO_SIDED|95.0|-44.2|17.4|||Longitudinal mixed analysis of variance|One sided p-value.||||17.4|-44.2|0.191
91577474|NCT02311673|183042868|OTHER||LS Mean Difference|19.5||||0.812|TWO_SIDED|95.0|-24.8|63.8||One sided p-value.|Longitudinal mixed analysis of variance||||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|63.8|-24.8|0.812
91577475|NCT02311673|183042868|OTHER||LS Mean Difference|-1.3||||0.464|TWO_SIDED|95.0|-29.9|27.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.4|-29.9|0.464
91577476|NCT02311673|183042868|OTHER||LS Mean Difference|-2.6||||0.432|TWO_SIDED|95.0|-33.6|28.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||28.4|-33.6|0.432
91577477|NCT02311673|183042869|OTHER||LS Mean Difference|49.9||||0.988|TWO_SIDED|95.0|6.7|93.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||93.2|6.7|0.988
91577478|NCT02311673|183042869|OTHER||LS Mean Difference|16.0||||0.859|TWO_SIDED|95.0|-13.7|45.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||45.6|-13.7|0.859
91577479|NCT02311673|183042869|OTHER||LS Mean Difference|22.2||||0.916|TWO_SIDED|95.0|-9.8|54.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.3|-9.8|0.916
91577480|NCT02311673|183042870|OTHER||LS Mean Difference|32.7||||0.943|TWO_SIDED|95.0|-8.4|73.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||73.8|-8.4|0.943
91577481|NCT02311673|183042870|OTHER||LS Mean Difference|-4.2||||0.339|TWO_SIDED|95.0|-24.4|16.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||16.1|-24.4|0.339
91577482|NCT02311673|183042870|OTHER||LS Mean Difference|1.1||||0.533|TWO_SIDED|95.0|-25.0|27.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.2|-25.0|0.533
91577483|NCT02311673|183042878|OTHER||LS Mean Difference|-0.2||||0.439|TWO_SIDED|95.0|-3.0|2.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.6|-3.0|0.439
91577484|NCT02311673|183042878|OTHER||LS Mean Difference|-0.3||||0.366|TWO_SIDED|95.0|-2.3|1.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.366
91577485|NCT02311673|183042878|OTHER||LS Mean Difference|0.7||||0.744|TWO_SIDED|95.0|-1.4|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-1.4|0.744
91577486|NCT02311673|183042879|OTHER||LS Mean Difference|1.0||||0.883|TWO_SIDED|95.0|-0.7|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-0.7|0.883
91577487|NCT02311673|183042879|OTHER||LS Mean Difference|-0.2||||0.338|TWO_SIDED|95.0|-1.3|0.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||0.9|-1.3|0.338
91577488|NCT02311673|183042879|OTHER||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-1.6|1.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.2|-1.6|0.381
91577489|NCT02311673|183042881|OTHER||LS Mean Difference|1.3||||0.679|TWO_SIDED|95.0|-4.5|7.0||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||7.0|-4.5|0.679
91577490|NCT02311673|183042881|OTHER||LS Mean Difference|0.7||||0.641|TWO_SIDED|95.0|-3.3|4.7||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||4.7|-3.3|0.641
91577491|NCT02311673|183042881|OTHER||LS Mean Difference|1.9||||0.809|TWO_SIDED|95.0|-2.6|6.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||6.4|-2.6|0.809
91577492|NCT02311673|183042882|OTHER||LS Mean Difference|0.5||||0.633|TWO_SIDED|95.0|-2.6|3.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.6|-2.6|0.633
91577493|NCT02311673|183042882|OTHER||LS Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-2.1|2.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.3|-2.1|0.528
91577494|NCT02311673|183042882|OTHER||LS Mean Difference|0.5||||0.648|TWO_SIDED|95.0|-2.0|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-2.0|0.648
91577495|NCT02311673|183042884|OTHER||LS Mean Difference|0.7||||0.712|TWO_SIDED|95.0|-1.8|3.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.1|-1.8|0.712
91577496|NCT02311673|183042884|OTHER||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-1.9|1.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.5|-1.9|0.414
91577497|NCT02311673|183042884|OTHER||LS Mean Difference|0.6||||0.732|TWO_SIDED|95.0|-1.3|2.5||One sided p-value|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-1.3|0.732
91577498|NCT01006252|183042886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.121
91577499|NCT01006252|183042887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.048||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|Analysis adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group||||||0.048
91577500|NCT01006252|183042888|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates||||||0.396
91577501|NCT01006252|183042890|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates.||||||0.483
91577502|NCT01006252|183042891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.505||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.505
91577503|NCT01006252|183042892|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
91577504|NCT01006252|183042892|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
91577505|NCT01006252|183042894|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
91577506|NCT01006252|183042894|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Overall Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
91577507|NCT01006252|183042895|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
91577508|NCT01006252|183042895|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
91577509|NCT01006252|183042897|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
91577510|NCT01006252|183042897|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
91577511|NCT00414908|183042907|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||<0.0001
91577512|NCT00414908|183042908|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||0.0002
91577513|NCT00414908|183042909|SUPERIORITY_OR_OTHER||LS Means difference|-112.45|||<|0.0001||95.0|-147.04|-77.87|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool fat at baseline as a covariate."||-77.87|-147.04|<0.0001
91577514|NCT00414908|183042910|SUPERIORITY_OR_OTHER||LS Means difference|-11.68|||<|0.0001||95.0|-17.3|-6.06|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo. For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool nitrogen at baseline as a covariate."||-6.06|-17.30|<0.0001
91577515|NCT00414908|183042911|SUPERIORITY_OR_OTHER||LS Means difference|-0.76||||0.005||95.0|-1.27|-0.24|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal). The hypothesis was to show superior efficacy of pancrelipase capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool frequency at baseline as a covariate."||-0.24|-1.27|0.005
91577516|NCT00414908|183042915|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|Mean difference based on all subjects combined using the paired t-test between baseline and visit 8 or early termination||||||<0.001
91577517|NCT00225017|183042916|NON_INFERIORITY_OR_EQUIVALENCE|25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%|Mean Difference (Net)|-0.384|STANDARD_DEVIATION|1.0||0.601|TWO_SIDED|95.0|-2.08|1.312|||Wilcoxon (Mann-Whitney)|||||1.312|-2.080|0.601
91577518|NCT00225017|183042917|SUPERIORITY_OR_OTHER||||||<|0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.009
91577519|NCT00225017|183042918|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.141
91577520|NCT03079297|183042932|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.5||0.4128|TWO_SIDED|95.0|-3.56|7.56|||t-test, 2 sided|||||7.56|-3.56|0.4128
91577521|NCT03079297|183042933|SUPERIORITY|||||||0.4286|||||||Fisher Exact|||||||0.4286
91577522|NCT03079297|183042934|SUPERIORITY|||||||0.999|||||||Fisher Exact|||||||.999
91577523|NCT03079297|183042935|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
91577524|NCT03079297|183042935|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
91577525|NCT03079297|183042935|SUPERIORITY|||||||0.2242||||||P-value for Adverse effect burden 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2242
91577526|NCT03079297|183042936|SUPERIORITY|||||||0.7282||||||P-value for General fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7282
91577527|NCT03079297|183042936|SUPERIORITY|||||||0.8781||||||P-value for General fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.8781
91577528|NCT03079297|183042936|SUPERIORITY|||||||0.226||||||P-value for General fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.226
91577529|NCT03079297|183042936|SUPERIORITY|||||||0.2158||||||P-value for Mental fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2158
91577530|NCT03079297|183042936|SUPERIORITY|||||||0.0081||||||P-value for Mental fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0081
91577531|NCT03079297|183042936|SUPERIORITY|||||||0.6768||||||P-value for Mental fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6768
91577532|NCT03079297|183042936|SUPERIORITY|||||||0.0076||||||P-value for Physical fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0076
91577533|NCT03079297|183042936|SUPERIORITY|||||||0.0858||||||P-value for Physical fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0858
91577534|NCT03079297|183042936|SUPERIORITY|||||||0.2065||||||P-value for Physical fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2065
91577535|NCT03079297|183042936|SUPERIORITY|||||||0.9712||||||P-value for Reduced motivation 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9712
91577536|NCT03079297|183042936|SUPERIORITY|||||||0.7572||||||P-value for Reduced motivation 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7572
91577537|NCT03079297|183042936|SUPERIORITY|||||||0.0588||||||P-value for Reduced motivation 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0588
91577538|NCT03079297|183042936|SUPERIORITY|||||||0.1857||||||P-value for Reduced activity 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.1857
91577539|NCT03079297|183042936|SUPERIORITY|||||||0.9225||||||P-value for Reduced activity 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9225
91577540|NCT03079297|183042936|SUPERIORITY|||||||0.0414||||||P-value for Reduced activity 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0414
91577541|NCT03079297|183042937|SUPERIORITY|||||||0.4603||||||P-value for Psychosocial function 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.4603
91577542|NCT03079297|183042937|SUPERIORITY|||||||0.2521||||||P-value for Psychosocial function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2521
91577543|NCT03079297|183042937|SUPERIORITY|||||||0.6635||||||P-value for Psychosocial function 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6635
91577544|NCT03079297|183042938|SUPERIORITY|||||||0.7839||||||P-value for Anhedonia 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7839
91577545|NCT03079297|183042938|SUPERIORITY|||||||0.0248||||||P-value for Anhedonia function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0248
91577546|NCT03079297|183042938|SUPERIORITY|||||||0.0199||||||P-value for Anhedonia 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0199
91577547|NCT01145898|183042984|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANCOVA|||There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.||||.6261
91577548|NCT01145898|183042985|SUPERIORITY_OR_OTHER|||||||0.6081||95.0|||||ANCOVA|||||||.6081
91577549|NCT01145898|183042986|SUPERIORITY_OR_OTHER|||||||0.1822||95.0|||||ANCOVA|||||||.1822
91577550|NCT01145898|183042987|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
91577551|NCT01145898|183042988|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
91577552|NCT01145898|183042989|SUPERIORITY_OR_OTHER|||||||0.1564||95.0|||||ANCOVA|||||||.1564
91577553|NCT01145898|183042990|SUPERIORITY_OR_OTHER|||||||0.2265||95.0|||||ANCOVA|||||||.2265
91577554|NCT01145898|183042991|SUPERIORITY_OR_OTHER|||||||0.4645||95.0|||||ANCOVA|||||||.4645
91577555|NCT01145898|183042992|SUPERIORITY_OR_OTHER|||||||0.5998||95.0|||||ANCOVA|||||||.5998
91577556|NCT01145898|183042993|SUPERIORITY_OR_OTHER|||||||0.8119||95.0|||||ANCOVA|||||||.8119
91577557|NCT01145898|183042994|SUPERIORITY_OR_OTHER|||||||0.1319||95.0|||||ANCOVA|||||||.1319
91577558|NCT01145898|183042995|SUPERIORITY_OR_OTHER|||||||0.0199||95.0|||||ANCOVA|||||||.0199
91577559|NCT01145898|183042996|SUPERIORITY_OR_OTHER|||||||0.7597||95.0|||||ANCOVA|||||||.7597
91577560|NCT01145898|183042997|SUPERIORITY_OR_OTHER|||||||0.2528||95.0|||||ANCOVA|||||||.2528
91577561|NCT00392925|183043009|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|||Based on an Analysis of Covariance model including factors for treatment group, sex, enrollment body mass index (BMI) category, lead-in body weight loss category, and baseline (Day 1) weight as a covariate. The p-value is for testing the null hypothesis of no difference between treatments. Analysis performed two-sided at a 5% significance level to compare treatment groups.||||0.0004
91577562|NCT04145700|183043035|SUPERIORITY||Posterior Mean Hazard Ratio|2.62||||0.051|TWO_SIDED|80.0|1.19|4.46|||Bayesian hierarchical model|||To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.||4.46|1.19|0.051
91577563|NCT01840410|183043055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.94|STANDARD_ERROR_OF_MEAN|1.502|<|0.001|TWO_SIDED|95.0|6.97|12.91|||Mixed Models Analysis|||||12.91|6.97|<0.001
91577564|NCT02206061|183043069|OTHER|Repeated measure analyses testing the overall treatment effect were performed by fitting the Generalized Estimating Equation (GEE) with SFD at the three follow-up time points (3, 5, 7 months) as the dependent variable and treatment as independent variable. Normal error and identity link was specified and standard error was calculated using Sandwich estimator. Baseline SFDs, poverty level, and the presence of smokers in the home were controlled in the regression model.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|2.6|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
91577565|NCT04608773|183043091|SUPERIORITY||||||<|0.501|||||||ANCOVA|||Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)||||<0.501
91577566|NCT04608773|183043092|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||.109
91577567|NCT04608773|183043093|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||.107
91577568|NCT04608773|183043094|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||.489
91577569|NCT04608773|183043095|SUPERIORITY|||||||0.213|||||||ANCOVA|||||||.213
91577570|NCT04608773|183043096|SUPERIORITY|||||||0.486|||||||ANCOVA|||||||.486
91577571|NCT02833077|183043098|SUPERIORITY||Responder Rate Difference|28.85||||0.0019|TWO_SIDED|95.0|11.16|45.6||If the 2-sided p-value is \< 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.|Fisher's exact test|||Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.||45.60|11.16|0.0019
91577572|NCT02833077|183043099|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.|Two sided paired t-test|||||||<.0001
91577573|NCT01077518|183043115|SUPERIORITY||Stratified Cox propor.hazards regression|0.82||||0.139|TWO_SIDED|95.0|0.62|1.07|||Stratified Log-Rank|||||1.07|0.62|0.1390
91577574|NCT01077518|183043116|OTHER||Stratified Cox propor.hazards regression|0.76||||0.1076|TWO_SIDED|95.0|0.55|1.06|||Stratified Log-Rank|||||1.06|0.55|0.1076
91577575|NCT01077518|183043117|OTHER|||||||0.8003|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for All participants||||0.8003
91577576|NCT01077518|183043118|OTHER|||||||0.613|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for Follicular Lymphoma (FL) participants||||0.6130
91577577|NCT01077518|183043119|OTHER||Hazard Ratio (HR)|0.87||||0.4046|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|||for All patients||1.21|0.62|0.4046
91577578|NCT01077518|183043120|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3768|TWO_SIDED|95.0|0.55|1.25|||Stratified Log Rank|||for FL participants||1.25|0.55|0.3768
91577579|NCT00972322|183043143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|8.7||0.083|TWO_SIDED|90.0|-29.87|-0.82|||Least Squares Means Difference||Placebo - MK-8245 on Day 28|||-0.82|-29.87|0.083
91577580|NCT00316017|183043154|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.||||0.91
91577581|NCT00316017|183043155|SUPERIORITY_OR_OTHER|||||||0.94||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.||||0.94
91577582|NCT00316017|183043156|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.73
91577583|NCT00316017|183043157|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.||||0.8
91577584|NCT00316017|183043158|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.69
91577585|NCT00316017|183043159|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.||||0.57
91577586|NCT00316017|183043160|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.66
91577587|NCT00316017|183043161|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.||||0.82
91577588|NCT00316017|183043162|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.||||0.98
91577589|NCT00316017|183043163|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.||||0.85
91577590|NCT00316017|183043164|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.||||0.48
91577591|NCT00316017|183043165|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.||||<0.01
91577592|NCT00316017|183043166|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.||||<0.02
91577593|NCT00316017|183043167|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.||||<0.01
91577594|NCT00316017|183043168|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.||||0.51
91577595|NCT00316017|183043169|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.||||0.73
91577596|NCT00316017|183043170|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.||||0.83
91577597|NCT00316017|183043171|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.||||0.31
91577598|NCT00316017|183043172|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.||||0.97
91577599|NCT00316017|183043174|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.||||0.35
91577600|NCT00316017|183043175|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.||||0.34
91577601|NCT04157400|183043176|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
91577602|NCT04157400|183043177|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91577603|NCT04157400|183043178|OTHER||||||||||||||||||Segments of EMG recorded during walking at self-selected walking speed were used to investigate complexity of muscle synergies using a nonnegative matrix factorization (NNMF) algorithm (MATLAB®, Mathworks, Natick, MA). The approach involves calculation of an mxt matrix of the original EMG data (EMG0), where m represents the number of muscles being measured and t represents a time base normalized to percentage of gait cycle. The algorithm also calculates two surrogate matrices, mxn and nxt, where n is the amplitude of muscle activation. The product of the surrogate matrices are considered a reconstruction of EMG (EMGr). EMGr for each module is then compared to EMG0 by finding the variability accounted for (VAF). A threshold necessary for module classification was chosen to be 90% for all conditions (8 muscles + 6 phases of gait) based on similar studies in the literature. Classifications were not increased unless the higher module VAF was at least 5% higher than the preceding module.|||
91577604|NCT00422812|183043179|SUPERIORITY|||||||0.0012||||||Overall effect at 2 hr (by Cochran-Mantel-Haenszel) for TREATMENT|Cochran-Mantel-Haenszel|||||||0.0012
91577605|NCT00422812|183043180|SUPERIORITY|||||||0.281|||||||Fisher Exact|||||||0.281
91577606|NCT00422812|183043180|SUPERIORITY|||||||0.0226|||||||Fisher Exact|||||||0.0226
91577607|NCT00422812|183043180|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
91577608|NCT00422812|183043181|SUPERIORITY|||||||0.0007||||||Overall effect (0-4 hr) for TREATMENT by Log-rank p-value|Log Rank|There was no adjustment for multiple comparisons.||||||0.0007
91577609|NCT00422812|183043181|SUPERIORITY|||||||0.0008|||||||Log Rank|No adjustments were made for multiple comparisons||||||0.0008
91577610|NCT00422812|183043181|SUPERIORITY|||||||0.0008||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0008
91577611|NCT00422812|183043181|SUPERIORITY|||||||0.0003||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0003
91577612|NCT02671500|183043192|SUPERIORITY||||||<|0.001|||||||2-sided 1 sample exact binomial test|||A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.||||<0.001
91577613|NCT03852719|183043235|OTHER||Difference in percentages|46.0|||<|0.0001|TWO_SIDED|96.0|30.5|61.4||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||61.4|30.5|<0.0001
91577614|NCT03852719|183043235|OTHER||Difference in percentages|42.9|||<|0.0001|TWO_SIDED|96.0|27.0|58.5||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||58.5|27.0|<0.0001
91577615|NCT03852719|183043236|OTHER||Difference in percentages|7.8||||0.4139|TWO_SIDED|96.0|-8.5|24.3||Fisher's exact test was used for the comparison of bulevirtide 10 mg versus bulevirtide 2 mg using a significance level of 0.04 at Week 48.|Fisher Exact|||||24.3|-8.5|0.4139
91577616|NCT03852719|183043237|OTHER||Difference in percentages|39.3|||<|0.0001|TWO_SIDED|95.0|20.0|55.8||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||55.8|20.0|<0.0001
91577617|NCT03852719|183043237|OTHER||Difference in percentage|44.2|||<|0.0001|TWO_SIDED|95.0|25.8|59.9||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||59.9|25.8|<0.0001
91577618|NCT03852719|183043238|OTHER||Difference in LS Mean|-4.02||||0.001|TWO_SIDED|95.0|-6.39|-1.65|||ANCOVA|||||-1.65|-6.39|0.0010
91577619|NCT03852719|183043238|OTHER||Difference in LS Mean|-3.93||||0.0009|TWO_SIDED|95.0|-6.23|-1.63|||ANCOVA|||||-1.63|-6.23|0.0009
91577620|NCT03852719|183043239|OTHER||Difference in Least Square (LS) Mean|0.57||||0.5156|TWO_SIDED|95.0|-1.16|2.3|||MMRM|||||2.30|-1.16|0.5156
91577621|NCT03852719|183043240|OTHER||Difference in Least Square (LS) Mean|-1.21||||0.2977|TWO_SIDED|95.0|-3.5|1.08|||MMRM|||||1.08|-3.50|0.2977
91577622|NCT03852719|183043241|SUPERIORITY||LS-Mean of Diffrence|-0.04||||0.9719|TWO_SIDED|95.0|-2.23|2.15||P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||2.15|-2.23|0.9719
91577623|NCT03852719|183043242|SUPERIORITY|P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|LS-Mean of Difference|2.11||||0.2369|TWO_SIDED|95.0|-1.41|5.63|||MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||5.63|-1.41|0.2369
91577624|NCT03852719|183043243|SUPERIORITY||Response Rate Difference|7.6||||0.4695|TWO_SIDED|95.0|-9.6|24.4||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||24.4|-9.6|0.4695
91577625|NCT03852719|183043243|SUPERIORITY||Response Rate Difference|-0.4||||1|TWO_SIDED|95.0|-16.3|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||15.5|-16.3|1.0000
91577626|NCT03852719|183043244|SUPERIORITY||Response Rate Difference|7.7||||0.4539|TWO_SIDED|95.0|-8.8|24.0||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||24.0|-8.8|0.4539
91577627|NCT03852719|183043244|SUPERIORITY||Response Rate Difference|-0.3||||1|TWO_SIDED|95.0|-15.6|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||15.5|-15.6|1.0000
91577628|NCT04201262|183043258|OTHER||Hazard Ratio (HR)|0.014|||<|0.0001|TWO_SIDED|95.0|0.0|0.103|||Log Rank||HR based on a Cox proportional hazards model, with Firth's adjustment. Confidence interval (CI)= Wald CI or Profile Likelihood CI Limits. HR for ravulizumab compared with placebo presented a 98.6% reduction in risk of relapse, 95% CI (89.7%, 100.0%).|||0.103|0.000|< 0.0001
91577629|NCT04201262|183043260|OTHER|||||||0.0122||||||Proportional Odds p-value|Univariate models|||The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.||||0.0122
91577630|NCT01647542|183043273|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.27|-0.78||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.78|-1.27|<0.001
91577631|NCT01647542|183043273|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.07|-0.57||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.57|-1.07|<0.001
91577632|NCT01647542|183043274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.001|TWO_SIDED|95.0|2.99|10.72||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||10.72|2.99|<0.001
91577633|NCT01647542|183043274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.81|6.49||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||6.49|1.81|<0.001
91577634|NCT01647542|183043275|SUPERIORITY_OR_OTHER||Least squares mean difference|-35.6|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.2|-26.9||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value covariate.||||-26.9|-44.2|<0.001
91577635|NCT01647542|183043275|SUPERIORITY_OR_OTHER||Least Squares mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.3|-27.1||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||||-27.1|-44.3|<0.001
91577636|NCT01647542|183043276|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|29.72||0.846|TWO_SIDED|95.0|-57.9|69.6||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||69.6|-57.9|0.846
91577637|NCT01647542|183043276|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|30.4||0.427|TWO_SIDED|95.0|-90.1|40.3||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||40.3|-90.1|0.427
91577638|NCT02819024|183043277|OTHER|||||||0.087|||||||t-test, 2 sided|||||||0.087
91577639|NCT03548220|183043312|SUPERIORITY||||||<|0.0001||||||2-sided p-value|Exact Cochran-Mantel-Haenszel|||||||<0.0001
91577640|NCT03548220|183043313|SUPERIORITY||LS Mean Difference|18.21|||<|0.0001|TWO_SIDED|95.0|12.41|24.01|||Mixed-effect Model Repeated Measure||Standard error = 2.913|||24.01|12.41|<0.0001
91577641|NCT03548220|183043316|SUPERIORITY||LS Mean Difference|-26.26|||<|0.0001|TWO_SIDED|95.0|-37.82|-14.7|||Mixed-effect Model Repeated Measure||Standard error = 5.788|||-14.70|-37.82|<0.0001
91577642|NCT03548220|183043317|SUPERIORITY||LS Mean Difference|-70.81||||0.0027|TWO_SIDED|95.0|-115.88|-25.74|||Mixed-effect Model Repeated Measure||Standard error = 22.488|||-25.74|-115.88|0.0027
91577643|NCT03548220|183043318|SUPERIORITY||LS Mean Difference|0.158||||0.0079|TWO_SIDED|95.0|0.043|0.273|||Mixed-effect Model Repeated Measure||Standard error = 0.0578|||0.273|0.043|0.0079
91577644|NCT03548220|183043319|SUPERIORITY||LS Mean Difference|-0.1011|||<|0.0001|TWO_SIDED|95.0|-0.1391|-0.0632|||Mixed-effect Model Repeated Measure||Standard error = 0.01904|||-0.0632|-0.1391|<0.0001
91577645|NCT03548220|183043320|SUPERIORITY||LS Mean Difference|-3.11||||0.0247|TWO_SIDED|95.0|-5.8|-0.41|||Mixed-effect Model Repeated Measure||Standard error = 1.352|||-0.41|-5.80|0.0247
91577646|NCT03548220|183043321|SUPERIORITY||LS Mean Difference|-3.25||||0.0421|TWO_SIDED|95.0|-6.39|-0.12|||Mixed-effect Model Repeated Measure||Standard error = 1.574|||-0.12|-6.39|0.0421
91577647|NCT04143945|183043401|OTHER|Comparison|Estimated treatment difference|2.6||||0.0395|TWO_SIDED|95.0|0.1|5.1|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||5.1|0.1|0.0395
91577648|NCT02187159|183043410|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.183||0.0008|TWO_SIDED|95.0|-0.97|-0.25|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.25|-0.97|0.0008
91577649|NCT02187159|183043410|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.183||0.0392|TWO_SIDED|95.0|-0.74|-0.02|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.02|-0.74|0.0392
91577650|NCT02187159|183043410|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.183||0.2192|TWO_SIDED|95.0|-0.58|0.13|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.13|-0.58|0.2192
91577651|NCT02187159|183043410|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.184||0.2095|TWO_SIDED|95.0|-0.13|0.59|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.59|-0.13|0.2095
91577652|NCT02187159|183043410|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0381|TWO_SIDED|95.0|0.02|0.75|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.75|0.02|0.0381
91577653|NCT02187159|183043412|SUPERIORITY||Mean Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|-10.71|-4.44|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-4.44|-10.71|<0.0001
91577654|NCT02187159|183043412|SUPERIORITY||Mean Difference (Final Values)|-3.52|STANDARD_ERROR_OF_MEAN|1.613||0.0289|TWO_SIDED|95.0|-6.68|-0.36|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.36|-6.68|0.0289
91577655|NCT02187159|183043412|SUPERIORITY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.625||0.1148|TWO_SIDED|95.0|-5.75|0.62|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.62|-5.75|0.1148
91577656|NCT02187159|183043412|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.621||0.0125|TWO_SIDED|95.0|0.87|7.23|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||7.23|0.87|0.0125
91577657|NCT02187159|183043412|SUPERIORITY||Mean Difference (Final Values)|5.01|STANDARD_ERROR_OF_MEAN|1.647||0.0023|TWO_SIDED|95.0|1.78|8.24|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||8.24|1.78|0.0023
91577658|NCT02187159|183043414|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-1.8|-0.7|||ANCOVA|||||-0.7|-1.8|<0.0001
91577659|NCT02187159|183043414|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0247|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||||-0.1|-1.2|0.0247
91577660|NCT02187159|183043414|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0411|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||-0.0|-1.1|0.0411
91577661|NCT02187159|183043414|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0352|TWO_SIDED|95.0|0.0|1.2|||ANCOVA|||||1.2|0.0|0.0352
91577662|NCT02187159|183043414|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0214|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||||1.2|0.1|0.0214
91577663|NCT02187159|183043415|SUPERIORITY||Difference of least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.26||0.0003|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||-0.4|-1.5|0.0003
91577664|NCT02187159|183043415|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5066|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.3|-0.7|0.5066
91577665|NCT02187159|183043415|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.1462|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.1|-0.9|0.1462
91577666|NCT02187159|183043415|SUPERIORITY||Difference of least squares means|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.0035|TWO_SIDED|95.0|0.3|1.3|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.3|0.3|0.0035
91577667|NCT02187159|183043415|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.0338|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.1|0.0|0.0338
91577668|NCT02187159|183043415|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0116|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||-0.2|-1.3|0.0116
91577669|NCT02187159|183043415|SUPERIORITY||Difference of least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7085|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.7085
91577670|NCT02187159|183043415|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9392|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.5|0.9392
91577671|NCT02187159|183043415|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0311|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.2|0.1|0.0311
91577672|NCT02187159|183043415|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0094|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.3|0.2|0.0094
91577673|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|1.256|STANDARD_ERROR_OF_MEAN|0.6027||0.0373|TWO_SIDED|95.0|0.074|2.439|||ANCOVA|||Physical Component: Placebo vs Pregabalin||2.439|0.074|0.0373
91577674|NCT02187159|183043416|SUPERIORITY||Difference of least squares means|0.364|STANDARD_ERROR_OF_MEAN|0.602||0.5458|TWO_SIDED|95.0|-0.817|1.545|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||1.545|-0.817|0.5458
91577675|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|0.235|STANDARD_ERROR_OF_MEAN|0.6038||0.6968|TWO_SIDED|95.0|-0.949|1.42|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||1.420|-0.949|0.6968
91577676|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|-0.893|STANDARD_ERROR_OF_MEAN|0.6014||0.1379|TWO_SIDED|95.0|-2.073|0.287|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg QD||0.287|-2.073|0.1379
91577677|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|-1.021|STANDARD_ERROR_OF_MEAN|0.6033||0.0908|TWO_SIDED|95.0|-2.205|0.163|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg BID||0.163|-2.205|0.0908
91577678|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|1.89|STANDARD_ERROR_OF_MEAN|0.6965||0.0068|TWO_SIDED|95.0|0.523|3.256|||ANCOVA|||Mental Component: Placebo vs Pregabalin||3.256|0.523|0.0068
91577679|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|0.406|STANDARD_ERROR_OF_MEAN|0.6956||0.5594|TWO_SIDED|95.0|-0.959|1.771|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.771|-0.959|0.5594
91577680|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|0.023|STANDARD_ERROR_OF_MEAN|0.6979||0.9736|TWO_SIDED|95.0|-1.346|1.392|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.392|-1.346|0.9736
91577681|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|-1.484|STANDARD_ERROR_OF_MEAN|0.6953||0.0331|TWO_SIDED|95.0|-2.848|-0.119|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg QD||-0.119|-2.848|0.0331
91577682|NCT02187159|183043416|SUPERIORITY||Difference in least squares means|-1.867|STANDARD_ERROR_OF_MEAN|0.6976||0.0076|TWO_SIDED|95.0|-3.235|-0.498|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg BID||-0.498|-3.235|0.0076
91577683|NCT02187159|183043417|SUPERIORITY||Difference in least squares means|0.0309|STANDARD_ERROR_OF_MEAN|0.01328||0.0201|TWO_SIDED|95.0|0.0048|0.057|||ANCOVA|||||0.0570|0.0048|0.0201
91577684|NCT02187159|183043417|SUPERIORITY||Difference of least squares means|0.0178|STANDARD_ERROR_OF_MEAN|0.01324||0.1798|TWO_SIDED|95.0|-0.0082|0.0438|||ANCOVA|||||0.0438|-0.0082|0.1798
91577685|NCT02187159|183043417|SUPERIORITY||Difference of least squares means|0.0071|STANDARD_ERROR_OF_MEAN|0.01329||0.5922|TWO_SIDED|95.0|-0.0189|0.0332|||ANCOVA|||||0.0332|-0.0189|0.5922
91577686|NCT02187159|183043417|SUPERIORITY||Difference in least squares means|-0.0131|STANDARD_ERROR_OF_MEAN|0.01326||0.3221|TWO_SIDED|95.0|-0.0392|0.0129|||ANCOVA|||||0.0129|-0.0392|0.3221
91577687|NCT02187159|183043417|SUPERIORITY||Difference in least squares means|-0.0238|STANDARD_ERROR_OF_MEAN|0.0133||0.0739|TWO_SIDED|95.0|-0.0499|0.0023|||ANCOVA|||||0.0023|-0.0499|0.0739
91577688|NCT02187159|183043418|SUPERIORITY||Difference in least squares means|-0.49|STANDARD_ERROR_OF_MEAN|0.153||0.0015|TWO_SIDED|95.0|-0.79|-0.19|||Mixed Models Analysis|||||-0.19|-0.79|0.0015
91577689|NCT02187159|183043418|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.153||0.0003|TWO_SIDED|95.0|-0.86|-0.26|||Mixed Models Analysis|||||-0.26|-0.86|0.0003
91577690|NCT02187159|183043418|SUPERIORITY||Difference in least squares means|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0008|TWO_SIDED|95.0|-0.81|-0.21|||Mixed Models Analysis|||||-0.21|-0.81|0.0008
91577691|NCT02187159|183043418|SUPERIORITY||Difference in least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.154||0.6464|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|||||0.23|-0.37|0.6464
91577692|NCT02187159|183043418|SUPERIORITY||Difference in least squares means|-0.03|STANDARD_ERROR_OF_MEAN|0.154||0.8543|TWO_SIDED|95.0|-0.33|0.27|||Mixed Models Analysis|||||0.27|-0.33|0.8543
91577693|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0014|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.2|-1.0|0.0014
91577694|NCT02187159|183043420|SUPERIORITY||Difference of least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1285|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1285
91577695|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6595|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6595
91577696|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0938|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0938
91577697|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0061|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0061
91577698|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0235|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.1|-0.8|0.0235
91577699|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3652|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3652
91577700|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.6885|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.3|-0.4|0.6885
91577701|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1726|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1726
91577702|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.0|0.0627
91577703|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0026|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.2|-0.8|0.0026
91577704|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1362|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.1362
91577705|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4344|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.4|0.4344
91577706|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1264|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1264
91577707|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.16||0.026|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|0.0|0.0260
91577708|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|0.0002
91577709|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0597|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0597
91577710|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1198|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.1|-0.7|0.1198
91577711|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.563|STANDARD_ERROR_OF_MEAN|0.1644||0.0006|TWO_SIDED|95.0|-0.885|-0.24|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.240|-0.885|0.0006
91577712|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.261|STANDARD_ERROR_OF_MEAN|0.164||0.1118|TWO_SIDED|95.0|-0.583|0.061|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.061|-0.583|0.1118
91577713|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.142|STANDARD_ERROR_OF_MEAN|0.1646||0.387|TWO_SIDED|95.0|-0.465|0.18|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.180|-0.465|0.3870
91577714|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.302|STANDARD_ERROR_OF_MEAN|0.1642||0.0633|TWO_SIDED|95.0|-0.02|0.624|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.624|-0.020|0.0633
91577715|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.42|STANDARD_ERROR_OF_MEAN|0.1647||0.0108|TWO_SIDED|95.0|0.097|0.744|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.744|0.097|0.0108
91577716|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|7.5|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|2.7|12.2|||ANCOVA|||Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID||12.2|2.7|0.0020
91577717|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|3.0|STANDARD_ERROR_OF_MEAN|2.41||0.2188|TWO_SIDED|95.0|-1.8|7.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg QD||7.7|-1.8|0.2188
91577718|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|4.0|STANDARD_ERROR_OF_MEAN|2.41||0.0991|TWO_SIDED|95.0|-0.8|8.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg BID||8.7|-0.8|0.0991
91577719|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-4.5|STANDARD_ERROR_OF_MEAN|2.41||0.0611|TWO_SIDED|95.0|-9.2|0.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.2|-9.2|0.0611
91577720|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-3.5|STANDARD_ERROR_OF_MEAN|2.41||0.1489|TWO_SIDED|95.0|-8.2|1.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.2|-8.2|0.1489
91577721|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-6.04|STANDARD_ERROR_OF_MEAN|1.751||0.0006|TWO_SIDED|95.0|-9.47|-2.6|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-2.60|-9.47|0.0006
91577722|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-4.09|STANDARD_ERROR_OF_MEAN|1.747||0.0193|TWO_SIDED|95.0|-7.52|-0.67|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||-0.67|-7.52|0.0193
91577723|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.752||0.3506|TWO_SIDED|95.0|-5.07|1.8|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.80|-5.07|0.3506
91577724|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|1.94|STANDARD_ERROR_OF_MEAN|1.748||0.266|TWO_SIDED|95.0|-1.48|5.37|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.37|-1.48|0.2660
91577725|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|4.4|STANDARD_ERROR_OF_MEAN|1.754||0.0122|TWO_SIDED|95.0|0.96|7.84|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||7.84|0.96|0.0122
91577726|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0119|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0119
91577727|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0659|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0659
91577728|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5104|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5104
91577729|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4934|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.4934
91577730|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0634|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0634
91577731|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0007|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.3|-1.1|0.0007
91577732|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0837|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0837
91577733|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2379|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.7|0.2379
91577734|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.098|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.0980
91577735|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0283|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0283
91577736|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2179|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2179
91577737|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6683|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6683
91577738|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2247|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.7|-0.2|0.2247
91577739|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4198|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.2|0.4198
91577740|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0146|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0146
91577741|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0662|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.0|-0.8|0.0662
91577742|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2282|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.2|-0.7|0.2282
91577743|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7336|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.7336
91577744|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.524|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.5240
91577745|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1349|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1349
91577746|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0464|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0464
91577747|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0975|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.0975
91577748|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6088|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.5|-0.3|0.6088
91577749|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7341|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.7341
91577750|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0125|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0125
91577751|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.5|-1.4|<0.0001
91577752|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||-0.4|-1.3|0.0003
91577753|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.2|-1.1|0.0040
91577754|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5801|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5801
91577755|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1869|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1869
91577756|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||-0.4|-1.3|0.0002
91577757|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0271|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||-0.1|-0.9|0.0271
91577758|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.1123|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.1|-0.8|0.1123
91577759|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1183|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1183
91577760|NCT02187159|183043420|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0299|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0299
91577761|NCT02187159|183043421|SUPERIORITY||Difference in least squares means|-0.015|STANDARD_ERROR_OF_MEAN|0.0249||0.5578|TWO_SIDED|95.0|-0.063|0.034|||ANCOVA|||||0.034|-0.063|0.5578
91577762|NCT02187159|183043421|SUPERIORITY||Difference in least squares means|-0.009|STANDARD_ERROR_OF_MEAN|0.0248||0.7034|TWO_SIDED|95.0|-0.058|0.039|||ANCOVA|||||0.039|-0.058|0.7034
91577763|NCT02187159|183043421|SUPERIORITY||Difference in least squares means|-0.02|STANDARD_ERROR_OF_MEAN|0.0249||0.4143|TWO_SIDED|95.0|-0.069|0.028|||ANCOVA|||||0.028|-0.069|0.4143
91577764|NCT02187159|183043421|SUPERIORITY||Difference in least squares means|0.005|STANDARD_ERROR_OF_MEAN|0.0249||0.8365|TWO_SIDED|95.0|-0.044|0.054|||ANCOVA|||||0.054|-0.044|0.8365
91577765|NCT02187159|183043421|SUPERIORITY||Difference in least squares means|-0.006|STANDARD_ERROR_OF_MEAN|0.0249||0.8189|TWO_SIDED|95.0|-0.055|0.043|||ANCOVA|||||0.043|-0.055|0.8189
91577766|NCT04833127|183043426|EQUIVALENCE|Null hypothesis: no difference between the groups|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.8||generalized linear models (GLM) and generalized estimating equations (GEE) for clustering within recruitment chain|GLM (logit link) with GEE|||||1.80|0.56|1.0
91577767|NCT04833127|183043426|EQUIVALENCE|Null H: No difference between the groups|Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.07||GLM with GEE to account for clustering by recruitment chain.|GLM (logit link) with GEE|Adjusted for age, education, if has a main male partner, which differed between the two groups at baseline.||||2.07|0.62|0.69
91577768|NCT04833127|183043427|EQUIVALENCE|Null hypothesis: No difference between the groups.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.35|2.85|||GLM with GEE|GLM with GEE accounting for clustering by recruitment chain||||2.85|0.35|1.00
91577769|NCT04833127|183043427|EQUIVALENCE|Null H: No difference between the 2 groups|Odds Ratio (OR)|0.95||||0.927|TWO_SIDED|95.0|0.31|2.9||GLM (logit link) with GEE to account for clustering by recruitment chain|GLM (logit link) with GEE|adjusted for baseline differences in age, educational status, and whether has a primary male partner.||||2.90|0.31|0.927
91577770|NCT04833127|183043428|EQUIVALENCE|Null Hypothesis: No difference between the groups|Odds Ratio (OR)|1.72||||0.215|TWO_SIDED|95.0|0.73|4.04|||GLM (logit link) with GEE|Used GEE to account for clustering by recruitment chain.||||4.04|0.73|0.215
91577771|NCT04833127|183043428|EQUIVALENCE|Null hypothesis: No difference between the groups|Odds Ratio (OR)|1.64||||0.295|TWO_SIDED|95.0|0.65|4.13|||GLM (logit link) with GEE|GEE used to account for clustering by recruitment chain|adjusted for baseline differences in age, education, and whether has a main male partner.|||4.13|0.65|0.295
91577772|NCT01240915|183043470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.223||0.96|TWO_SIDED|80.0|0.12|0.69||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||0.69|0.12|0.96
91577773|NCT01240915|183043471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.161||0.54|TWO_SIDED|80.0|-0.19|0.22||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 4)||0.22|-0.19|0.54
91577774|NCT01240915|183043472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.67|TWO_SIDED|80.0|-0.15|0.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 8)||0.30|-0.15|0.67
91577775|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02||||0.53|TWO_SIDED|80.0|0.73|1.42||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.42|0.73|0.53
91577776|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.48||||0.91|TWO_SIDED|80.0|1.02|2.14||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||2.14|1.02|0.91
91577777|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.38||||0.81|TWO_SIDED|80.0|0.86|2.23||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.23|0.86|0.81
91577778|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94||||0.44|TWO_SIDED|80.0|0.59|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.51|0.59|0.44
91577779|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18||||0.67|TWO_SIDED|80.0|0.72|1.94||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.94|0.72|0.67
91577780|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||0.62|TWO_SIDED|80.0|0.68|1.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||1.84|0.68|0.62
91577781|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.95|TWO_SIDED|80.0|0.58|1.57||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.57|0.58|0.95
91577782|NCT01240915|183043479|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.81||||0.3|TWO_SIDED|80.0|0.49|1.36||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.36|0.49|0.30
91577783|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.17||||0.79|TWO_SIDED|80.0|0.91|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.51|0.91|0.79
91577784|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21||||0.8|TWO_SIDED|80.0|0.9|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||1.63|0.90|0.80
91577785|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.75||||0.99|TWO_SIDED|80.0|1.63|4.64||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||4.64|1.63|0.99
91577786|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.96||||0.96|TWO_SIDED|80.0|1.19|3.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.25|1.19|0.96
91577787|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.98||||0.95|TWO_SIDED|80.0|1.15|3.41||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||3.41|1.15|0.95
91577788|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.3||||0.99|TWO_SIDED|80.0|1.52|3.48||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||3.48|1.52|0.99
91577789|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1||||0.62|TWO_SIDED|80.0|0.74|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.63|0.74|0.62
91577790|NCT01240915|183043480|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.51||||0.89|TWO_SIDED|80.0|0.98|2.32||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||2.32|0.98|0.89
91577791|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.34|TWO_SIDED|80.0|0.66|2.19||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||2.19|0.66|0.34
91577792|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.33|TWO_SIDED|80.0|0.68|2.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||2.23|0.68|0.33
91577793|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.1|TWO_SIDED|80.0|0.99|5.67||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||5.67|0.99|0.10
91577794|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.74|TWO_SIDED|80.0|0.28|1.55||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.55|0.28|0.74
91577795|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.48|TWO_SIDED|80.0|0.41|2.64||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||2.64|0.41|0.48
91577796|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.58|TWO_SIDED|80.0|0.38|2.03||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.03|0.38|0.58
91577797|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.68|TWO_SIDED|80.0|0.33|1.66||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.66|0.33|0.68
91577798|NCT01240915|183043481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.84|TWO_SIDED|80.0|0.21|1.23||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.23|0.21|0.84
91577799|NCT01240915|183043482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.57|TWO_SIDED|80.0|0.22|3.07||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||3.07|0.22|0.57
91577800|NCT01240915|183043483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.85|TWO_SIDED|80.0|0.12|1.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.23|0.12|0.85
91577801|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.05|TWO_SIDED|80.0|1.21|4.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||4.24|1.21|0.05
91577802|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.43|TWO_SIDED|80.0|0.61|1.95||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||1.95|0.61|0.43
91577803|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.44|TWO_SIDED|80.0|0.45|2.76||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.76|0.45|0.44
91577804|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.38|TWO_SIDED|80.0|0.5|3.04||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.04|0.50|0.38
91577805|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.89|TWO_SIDED|80.0|0.14|1.04||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.04|0.14|0.89
91577806|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.47|TWO_SIDED|80.0|0.45|2.42||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.42|0.45|0.47
91577807|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.24|TWO_SIDED|80.0|0.7|3.57||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||3.57|0.70|0.24
91577808|NCT01240915|183043484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.81|TWO_SIDED|80.0|0.22|1.32||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.32|0.22|0.81
91577809|NCT01240915|183043485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.84|TWO_SIDED|80.0|0.2|1.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.24|0.20|0.84
91577810|NCT01240915|183043486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.96|TWO_SIDED|80.0|0.12|0.73||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||0.73|0.12|0.96
91577811|NCT01240915|183043487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.513||0.87|TWO_SIDED|80.0|-0.08|1.24||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.24|-0.08|0.87
91577812|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.345||0.8|TWO_SIDED|80.0|-0.15|0.74||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.74|-0.15|0.80
91577813|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.418||0.77|TWO_SIDED|80.0|-0.23|0.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.84|-0.23|0.77
91577814|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.666||0.74|TWO_SIDED|80.0|-0.42|1.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||1.30|-0.42|0.74
91577815|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.645||0.88|TWO_SIDED|80.0|-0.08|1.59||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.59|-0.08|0.88
91577816|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.705||0.72|TWO_SIDED|80.0|-0.5|1.33||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.33|-0.50|0.72
91577817|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.656||0.97|TWO_SIDED|80.0|0.37|2.06||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.06|0.37|0.97
91577818|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.635||0.75|TWO_SIDED|80.0|-0.39|1.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.25|-0.39|0.75
91577819|NCT01240915|183043488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.692||0.85|TWO_SIDED|80.0|-0.16|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.63|-0.16|0.85
91577820|NCT01240915|183043489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.753||0.75|TWO_SIDED|80.0|-0.46|1.49||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.49|-0.46|0.75
91577821|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.51|TWO_SIDED|80.0|-0.18|0.19||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.19|-0.18|0.51
91577822|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.158||0.62|TWO_SIDED|80.0|-0.16|0.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.25|-0.16|0.62
91577823|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.213||0.29|TWO_SIDED|80.0|-0.39|0.16||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||0.16|-0.39|0.29
91577824|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.209||0.74|TWO_SIDED|80.0|-0.14|0.4||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||0.40|-0.14|0.74
91577825|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.226||0.36|TWO_SIDED|80.0|-0.37|0.21||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||0.21|-0.37|0.36
91577826|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.234||0.56|TWO_SIDED|80.0|-0.26|0.34||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||0.34|-0.26|0.56
91577827|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.231||0.18|TWO_SIDED|80.0|-0.51|0.09||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||0.09|-0.51|0.18
91577828|NCT01240915|183043490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.31|TWO_SIDED|80.0|-0.45|0.2||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||0.20|-0.45|0.31
91577829|NCT02574845|183043493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.95|||||TWO_SIDED|90.0|89.49|116.15|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||116.15|89.49|
91577830|NCT02574845|183043493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.09|||||TWO_SIDED|90.0|96.12|117.11|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.11|96.12|
91577831|NCT02574845|183043493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|152.18|||||TWO_SIDED|90.0|135.12|171.41|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||171.41|135.12|
91577832|NCT02574845|183043493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.97|||||TWO_SIDED|90.0|94.34|121.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.30|94.34|
91577833|NCT02574845|183043493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|115.92|||||TWO_SIDED|90.0|101.93|131.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||131.82|101.93|
91577834|NCT02574845|183043494|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|102.47|||||TWO_SIDED|90.0|87.19|120.42|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||120.42|87.19|
91577835|NCT02574845|183043494|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.98|||||TWO_SIDED|90.0|92.54|123.69|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||123.69|92.54|
91577836|NCT02574845|183043494|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|154.07|||||TWO_SIDED|90.0|131.7|180.24|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||180.24|131.70|
91577837|NCT02574845|183043494|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.81|||||TWO_SIDED|90.0|91.78|124.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||124.30|91.78|
91577838|NCT02574845|183043494|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|117.98|||||TWO_SIDED|90.0|98.27|141.65|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||141.65|98.27|
91577839|NCT02574845|183043495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.22|||||TWO_SIDED|90.0|89.23|114.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||114.82|89.23|
91577840|NCT02574845|183043495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|107.26|||||TWO_SIDED|90.0|97.65|117.81|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.81|97.65|
91577841|NCT02574845|183043495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|146.45|||||TWO_SIDED|90.0|135.21|158.62|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||158.62|135.21|
91577842|NCT02574845|183043495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|105.63|||||TWO_SIDED|90.0|92.2|121.0|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.00|92.20|
91577843|NCT02574845|183043495|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|118.1|||||TWO_SIDED|90.0|106.75|130.67|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||130.67|106.75|
91577844|NCT03151993|183043499|NON_INFERIORITY|The non-inferiority hypothesis would be declared if the lower limit of the 95% CI for an mRS score of 0-1 on day 90 did not cross the margin of noninferiority of 16%. The non-inferiority hypothesis was tested using Welch's t-test for the primary outcome only.|Odds Ratio (OR)|9.5|||<|0.01|TWO_SIDED|95.0|-1.7|20.7|||Welch's t-test|||||20.7|-1.7|<0.01
91577845|NCT03101462|183043512|OTHER|ANOVA||||||0.89|||||||t-test, 2 sided|||A/H1N1 Day 0||||0.89
91577846|NCT03101462|183043512|OTHER|||||||0.00082||||||This is the calculated p-value.|t-test, 2 sided|||A/H1N1 Day 7||||0.00082
91577847|NCT03101462|183043512|OTHER|||||||7.6e-05||||||This is the calculated p-value|t-test, 2 sided|||A/H1N1 Day 45||||0.000076
91577848|NCT03101462|183043512|OTHER|||||||0.63|||||||t-test, 2 sided|||A/H3N2 Day 0||||0.63
91577849|NCT03101462|183043512|OTHER|||||||0.0186||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 7||||0.0186
91577850|NCT03101462|183043512|OTHER|||||||0.0052||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 45||||0.0052
91577851|NCT03101462|183043512|OTHER|||||||0.25|||||||t-test, 2 sided|||Influenza B Day 0||||0.25
91577852|NCT03101462|183043512|OTHER|||||||0.061|||||||t-test, 2 sided|||Influenza B Day 7||||0.061
91577853|NCT03101462|183043512|OTHER|||||||0.0025|||||||t-test, 2 sided|||Influenza B Day 45||||0.0025
91577854|NCT03101462|183043513|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.24
91577855|NCT03101462|183043513|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.76
91577856|NCT03101462|183043513|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.06
91577857|NCT03101462|183043513|OTHER|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.56
91577858|NCT03101462|183043513|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.04
91577859|NCT03101462|183043513|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.16
91577860|NCT03101462|183043513|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.02
91577861|NCT03101462|183043513|OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.94
91577862|NCT03101462|183043513|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.002
91577863|NCT03101462|183043513|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.16
91577864|NCT03101462|183043513|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.02
91577865|NCT03101462|183043513|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.98
91577866|NCT03101462|183043514|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.04
91577867|NCT03101462|183043514|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.02
91577868|NCT03101462|183043514|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.95
91577869|NCT03101462|183043514|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.17
91577870|NCT03101462|183043514|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.06
91577871|NCT03101462|183043514|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.14
91577872|NCT03101462|183043514|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.02
91577873|NCT03101462|183043514|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.09
91577874|NCT03101462|183043514|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.01
91577875|NCT03101462|183043514|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.08
91577876|NCT03101462|183043514|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.16
91577877|NCT03101462|183043514|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.76
91577878|NCT03101462|183043514|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.84
91577879|NCT03101462|183043514|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.04
91577880|NCT03101462|183043514|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.07
91577881|NCT03101462|183043514|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.27
91577882|NCT03101462|183043514|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.11
91577883|NCT03101462|183043514|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.46
91577884|NCT03101462|183043514|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.006
91577885|NCT03101462|183043514|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.41
91577886|NCT03101462|183043515|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.72
91577887|NCT03101462|183043515|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and 45||||0.06
91577888|NCT03101462|183043515|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.75
91577889|NCT03101462|183043515|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.05
91577890|NCT03101462|183043515|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and Day 45||||0.0004
91577891|NCT03101462|183043515|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.02
91577892|NCT03101462|183043516|OTHER|||||||0.02|||||||Fisher Exact|||Fold increase IgA anti-H1N1 HA, Day 7||||0.02
91577893|NCT03101462|183043516|OTHER|||||||0.67|||||||Fisher Exact|||Fold increase IgA anti-H3N2, Day 7||||0.67
91577894|NCT03101462|183043516|OTHER|||||||0.3|||||||Fisher Exact|||Fold increase IgA anti-influenza B HA, Day 7||||0.30
91577895|NCT01669577|183043619|SUPERIORITY_OR_OTHER||GEE(Generalyzed Estimation Equation)|0.989214|||<|0.001|TWO_SIDED|95.0|0.982855|0.995613||arterial hemoglobin Oxygen saturation|ANOVA|Non parametric(NPar) ANOVA|GEE model (dichotomous response variable)with logit link function. The NPar ANOVA (p\<0.1 for death) was the test used for inclusion in the model variables for the final models - backward method, with alpha equal to 0.05.|"significance level of 0.05, power of 0.80, moderate correlation of 0.5 between time periods and assumption that the variability is equal within each factor (non-sphericity). Due to the effect size between 0.1 and 0.5, there was no need for samples larger than 140 patients. A total of 200 patients was defined conservatively, with a margin for possible deaths. The software G\*Power 3.1.7 was used for sample size calculation.~Fischer's test, Mann-Whitney, t-test; Non parametric ANOVA and GEE"||0.995613|0.982855|< 0.001
91577896|NCT01669577|183043619|SUPERIORITY_OR_OTHER||GEE|0.99728|||<|0.001|TWO_SIDED|95.0|0.995791|0.998772|||ANOVA|||diastolic arterial blood pressure||0.998772|0.995791|< 0.001
91577897|NCT01669577|183043619|SUPERIORITY_OR_OTHER||GEE|1.046961|||<|0.004|TWO_SIDED|95.0|1.012521|1.082572|||ANOVA|||lactate||1.082572|1.012521|< 0.004
91577898|NCT01669577|183043619|SUPERIORITY_OR_OTHER||GEE|0.973987|||<|0.001|TWO_SIDED|95.0|0.965308|0.982744|||ANOVA|||Glasgow coma score||0.982744|0.965308|<0.001
91577899|NCT01669577|183043619|SUPERIORITY_OR_OTHER||GEE|1.000013|||<|0.023|TWO_SIDED|95.0|1.0|1.000025|||ANOVA|||amount of Infused crystalloids||1.000025|1.000000|<0.023
91577900|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.86||||0.0648|TWO_SIDED|95.0|0.75|0.99||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group||0.99|0.75|0.0648
91577901|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.85||||0.0241|TWO_SIDED|95.0|0.74|0.98||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group||0.98|0.74|0.0241
91577902|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.93||||0.1895|TWO_SIDED|95.0|0.8|1.07||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.||1.07|0.80|0.1895
91577903|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.572|TWO_SIDED|95.0|0.77|1.16||2-sided unadjusted p-value|Regression, Cox||CV death|||1.16|0.77|0.572
91577904|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.296|TWO_SIDED|95.0|0.73|1.1||2-sided unadjusted p-value|Regression, Cox||CV death|||1.10|0.73|0.296
91577905|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.91||||0.369|TWO_SIDED|95.0|0.73|1.12||2-sided unadjusted p-value|Regression, Cox||CV death|||1.12|0.73|0.369
91577906|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.84||||0.067|TWO_SIDED|95.0|0.69|1.01||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.01|0.69|0.067
91577907|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76||||0.006|TWO_SIDED|95.0|0.63|0.92||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||0.92|0.63|0.006
91577908|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.542|TWO_SIDED|95.0|0.78|1.14||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.14|0.78|0.542
91577909|NCT01327846|183043630|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.68|1.0|||||MI (non-fatal)|||1.00|0.68|
91577910|NCT01327846|183043630|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.62|0.92|||||MI (non-fatal)|||0.92|0.62|
91577911|NCT01327846|183043630|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.78|1.14|||||MI (non-fatal)|||1.14|0.78|
91577912|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.56|1.12||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.12|0.56|0.190
91577913|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.912|TWO_SIDED|95.0|0.71|1.35||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.35|0.71|0.912
91577914|NCT01327846|183043630|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.03||||0.871|TWO_SIDED|95.0|0.74|1.43||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.43|0.74|0.871
91577915|NCT01327846|183043630|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.57|1.13|||||Stroke (nonfatal)|||1.13|0.57|
91577916|NCT01327846|183043630|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.72|1.37|||||Stroke (nonfatal)|||1.37|0.72|
91577917|NCT01327846|183043630|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.75|1.45|||||Stroke (nonfatal)|||1.45|0.75|
91577918|NCT01327846|183043633|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.82||||0.0648|TWO_SIDED|95.0|0.72|0.94||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.94|0.72|0.0648
91577919|NCT01327846|183043633|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83||||0.0241|TWO_SIDED|95.0|0.73|0.95||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.95|0.73|0.0241
91577920|NCT01327846|183043633|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.1895|TWO_SIDED|95.0|0.79|1.03||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||1.03|0.79|0.1895
91577921|NCT01327846|183043633|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.58||||0.007|TWO_SIDED|95.0|0.39|0.86||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.86|0.39|0.007
91577922|NCT01327846|183043633|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.64||||0.022|TWO_SIDED|95.0|0.44|0.94||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.94|0.44|0.022
91577923|NCT01327846|183043633|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.71||||0.086|TWO_SIDED|95.0|0.48|1.05||2-sided unadjusted p-value|Regression, Cox||unstable angina|||1.05|0.48|0.086
91577924|NCT01327846|183043634|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.01||||0.8456|TWO_SIDED|95.0|0.83|1.23||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.23|0.83|0.8456
91577925|NCT01327846|183043634|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.06||||0.8456|TWO_SIDED|95.0|0.87|1.29||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.29|0.87|0.8456
91577926|NCT01327846|183043634|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.6541|TWO_SIDED|95.0|0.8|1.2||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.20|0.80|0.6541
91577927|NCT01327846|183043635|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.028|TWO_SIDED|95.0|0.77|0.99||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.99|0.77|0.028
91577928|NCT01327846|183043635|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.011|TWO_SIDED|95.0|0.75|0.96||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.96|0.75|0.011
91577929|NCT01327846|183043635|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.377|TWO_SIDED|95.0|0.83|1.07||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||1.07|0.83|0.377
91577930|NCT01327846|183043636|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.93||||0.406|TWO_SIDED|95.0|0.79|1.1||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.10|0.79|0.406
91577931|NCT01327846|183043636|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.92||||0.329|TWO_SIDED|95.0|0.78|1.09||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.09|0.78|0.329
91577932|NCT01327846|183043636|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.96||||0.597|TWO_SIDED|95.0|0.81|1.13||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.13|0.81|0.597
91577933|NCT03746392|183043676|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
91577934|NCT03843554|183043737|SUPERIORITY|Primary hypothesis. Null hypothesis is that the proportion of patients with a successful outcome of WHO OM severity grades 0-2 at the post study evaluation will not differ between the two randomized intervention groups. The estimated proportion of successes from our pilot trial is 0.30 with SOC. The alternative hypothesis is that the proportion of patients with a successful outcome differs between the two groups from the SOC proportion of 0.30 by +/-0.265 or more.||||||0.999|||||||Fisher Exact|OM WHO grading scale (less or equal to 2) severity employed a two-sided Fisher's exact test to compare the two arms at Visit 9.||||||0.999
91577935|NCT03843554|183043738|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|174.6||0.6336|TWO_SIDED|95.0||||The above t-test p-value is for IL1a.|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t-test was used to compare the change in inflammatory markers between the two groups.||||0.6336
91577936|NCT03843554|183043738|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|52.1||0.351|TWO_SIDED|95.0||||IL1b|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
91577937|NCT03843554|183043738|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-102.2|STANDARD_ERROR_OF_MEAN|252.8||0.351|TWO_SIDED|95.0||||IL2|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
91577938|NCT03843554|183043738|SUPERIORITY|IL4|Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|46.0||0.8371|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.8371
91577939|NCT03843554|183043738|SUPERIORITY|IL5|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|10.7||0.2991|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.2991
91577940|NCT03843554|183043739|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.2293|STANDARD_ERROR_OF_MEAN|0.8555||0.2373|TWO_SIDED|95.0|-1.906|1.4475|||t-test, 2 sided|||||1.4475|-1.9060|0.2373
91577941|NCT03843554|183043740|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.116||0.6263|TWO_SIDED|95.0|-0.1755|0.2893||A Week 8 general linear mixed effects model (GLM) was used to compare the change in saliva flow rate from Baseline (day 0) to week 8 (day 56) between the two groups. The change was calculated by subtracting week 8 saliva flow rate from the Baseline.|ANCOVA||Estimation of the difference in least-square means for the change from Baseline to FIV in saliva flow rate.|||0.2893|-0.1755|0.6263
91577942|NCT03843554|183043741|SUPERIORITY|OMDP-STANDARD|Mean Difference (Net)|-1.94||||0.6956|TWO_SIDED|95.0|||||Regression, Linear|A Week 8 (Day 56) GLM analyzing the pain change Week 8 relative to Baseline (Day 0) was used with treatment and Baseline pain as covariates.|Difference in least-square mean change from baseline to Visit 9 in pain score.|||||0.6956
91577943|NCT03843554|183043742|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.113||0.1153|TWO_SIDED|95.0|-0.4095|0.0334|||ANCOVA|ANCOVA via generalized linear mixed repeated measures model (GLMER)||The statistical analysis comprised an ANCOVA for a longitudinal response based on a generalized linear mixed effects repeated measures model (GLMER). The response variable is the mean change from Baseline to Visit 9 in EORTC QLQ-C30 Questions 31-48 (total).||0.0334|-0.4095|0.1153
91577944|NCT02385240|183043793|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.034|||||TWO_SIDED|90.0|-7.52|10.72|||Wald's method|||||10.72|-7.52|
91577945|NCT02385240|183043794|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.05|||||TWO_SIDED|90.0|-6.94|11.33|||Wald's method|||||11.33|-6.94|
91577946|NCT02385240|183043795|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.26|||||TWO_SIDED|90.0|-1.77|15.46|||Wald's method|||||15.46|-1.77|
91577947|NCT00567567|183043812|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|6.9883||||0.0082|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.||||0.0082
91577948|NCT00567567|183043813|SUPERIORITY_OR_OTHER_LEGACY||Chi-squared test statistic|8.5751||||0.0034|TWO_SIDED|95.0|||||Chi-squared|||Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.||||0.0034
91577949|NCT00567567|183043814|SUPERIORITY_OR_OTHER_LEGACY||Gray's test statistic|0.33709||||0.5615|TWO_SIDED|95.0|||||Gray's test for competing risks|||The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.||||0.5615
91577950|NCT00567567|183043815|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0557||||0.0939|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0939
91577951|NCT00567567|183043816|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.0543||||0.3277|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.3277
91577952|NCT00567567|183043817|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4328||||0.7598|TWO_SIDED|95.0|0.4105|5.001|||Fisher Exact|Fisher's exact test was used instead of chi-square test due to small expected cell counts.||Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population||5.001|0.4105|0.7598
91577953|NCT00567567|183043821|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.015||||0.6853|TWO_SIDED|95.0|||||Regression, Cox|||The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.||||0.6853
91577954|NCT03433677|183043829|SUPERIORITY||Median Difference (Final Values)|0.0||||0.375|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon signed-rank test|||||0.00|0.00|0.375
91577955|NCT03433677|183043830|SUPERIORITY|||||||0.468|||||||Prescott's Exact test|||||||0.468
91577956|NCT03433677|183043831|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
91577957|NCT03433677|183043832|SUPERIORITY||LSMean Difference|-1.8||||0.304|TWO_SIDED|95.0|-5.3|1.7|||Mixed Models Analysis|||||1.7|-5.3|0.304
91577958|NCT03433677|183043833|SUPERIORITY||LSMean Difference|-2.4||||0.057|TWO_SIDED|95.0|-4.8|0.1|||Mixed Models Analysis|||||0.1|-4.8|0.057
91577959|NCT03433677|183043834|SUPERIORITY||LSMeans|0.11||||0.177|TWO_SIDED|95.0|-0.05|0.27|||Mixed Models Analysis||LSMean Difference|||0.27|-0.05|0.177
91577960|NCT04552899|183043881|SUPERIORITY||Difference in Change from Baseline|-20.83|STANDARD_ERROR_OF_MEAN|34.11||0.54|TWO_SIDED|95.0|-87.94|46.29|||RCRM|Random Coefficient Regression Model (RCRM)||||46.29|-87.94|0.54
91577961|NCT04552899|183043884|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2512|TWO_SIDED|95.0|0.91|1.47|||Log Rank|||||1.47|0.91|0.2512
91577962|NCT04552899|183043885|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9833|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.9833
91577963|NCT04552899|183043888|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.7005|TWO_SIDED|95.0|0.4|1.86|||Log Rank|||||1.86|0.40|0.7005
91577964|NCT00461981|183043902|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.6||||||95.0|-79.7|-31.7||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-31.7|-79.7|
91577965|NCT00461981|183043903|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.9||||||95.0|-83.8|-26.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-26.0|-83.8|
91577966|NCT00461981|183043904|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|44.2||||||95.0|12.0|67.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||67.8|12.0|
91577967|NCT00461981|183043905|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|16.2||||||95.0|-17.6|45.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||45.4|-17.6|
91577968|NCT00461981|183043906|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-18.2||||||95.0|-40.0|4.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.9|-40.0|
91577969|NCT00461981|183043907|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.6||||||95.0|-27.4|13.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||13.3|-27.4|
91577970|NCT00461981|183043908|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|35.7||||||95.0|9.5|57.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||57.1|9.5|
91577971|NCT00461981|183043909|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.0||||||95.0|-27.7|16.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||16.0|-27.7|
91577972|NCT00461981|183043910|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|14.7||||||95.0|-6.5|38.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||38.4|-6.5|
91577973|NCT00461981|183043911|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|38.1||||||95.0|0.9|65.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||65.9|0.9|
91577974|NCT00461981|183043912|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|11.7||||||95.0|-13.0|34.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||34.9|-13.0|
91577975|NCT00461981|183043913|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-15.8||||||95.0|-40.7|8.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||8.0|-40.7|
91577976|NCT00461981|183043914|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|0.43||||||95.0|0.24|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.24|
91577977|NCT00461981|183043915|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.2||||||95.0|0.09|0.48||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.48|0.09|
91577978|NCT00461981|183043916|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.36||||||95.0|1.54|7.13||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||7.13|1.54|
91577979|NCT00461981|183043917|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|3.26||||||95.0|1.44|7.19||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.19|1.44|
91577980|NCT00461981|183043918|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.06||||||95.0|0.56|1.96||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.96|0.56|
91577981|NCT00461981|183043919|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.58||||||95.0|0.31|1.12||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.12|0.31|
91577982|NCT00461981|183043920|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.4||||||95.0|1.48|3.97||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.97|1.48|
91577983|NCT00461981|183043921|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.48||||||95.0|0.27|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.27|
91577984|NCT00461981|183043922|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.45||||||95.0|0.8|2.66||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.66|0.80|
91577985|NCT00461981|183043923|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.75||||||95.0|0.88|3.39||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.39|0.88|
91514173|NCT04079933|182900464|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.13||||0.4903|TWO_SIDED|95.0|-4.35|2.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.10|-4.35|0.4903
91577986|NCT00461981|183043924|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.49||||||95.0|0.8|2.69||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.69|0.80|
91577987|NCT00461981|183043925|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.62||||||95.0|0.33|1.16||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.16|0.33|
91577988|NCT00461981|183043926|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-45.9||||||95.0|-71.7|-11.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-11.6|-71.7|
91577989|NCT00461981|183043927|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-25.0||||||95.0|-57.2|4.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.8|-57.2|
91577990|NCT00461981|183043928|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|65.0||||||95.0|34.4|85.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||85.3|34.4|
91577991|NCT00461981|183043929|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-0.6||||||95.0|-30.4|30.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||30.3|-30.4|
91577992|NCT00461981|183043930|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-37.0||||||95.0|-57.8|-17.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-17.5|-57.8|
91577993|NCT00461981|183043931|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-8.3||||||95.0|-38.5|14.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||14.5|-38.5|
91577994|NCT00461981|183043932|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|21.9||||||95.0|-6.7|48.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||48.1|-6.7|
91577995|NCT00461981|183043933|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-22.4||||||95.0|-54.4|12.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||12.2|-54.4|
91577996|NCT00461981|183043934|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|33.3||||||95.0|-81.1|90.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||90.6|-81.1|
91577997|NCT00461981|183043935|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|0.0||||||95.0|-97.5|84.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||84.2|-97.5|
91577998|NCT00461981|183043936|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-9.5||||||95.0|-65.2|58.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||58.8|-65.2|
91577999|NCT00461981|183043937|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-20.0||||||95.0|-71.6|33.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||33.9|-71.6|
91578000|NCT00461981|183043938|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.23||||||95.0|0.15|0.35||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.35|0.15|
91578001|NCT00461981|183043939|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.11||||||95.0|0.05|0.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.22|0.05|
91578002|NCT00461981|183043940|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.85||||||95.0|2.51|9.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||9.22|2.51|
91578003|NCT00461981|183043941|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.31||||||95.0|1.46|7.54||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.54|1.46|
91578004|NCT00461981|183043942|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.35||||||95.0|0.58|3.04||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.04|0.58|
91578005|NCT00461981|183043943|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.44||||||95.0|0.16|1.07||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.07|0.16|
91578006|NCT00461981|183043944|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.46||||||95.0|1.26|5.06||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||5.06|1.26|
91578007|NCT00461981|183043945|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.89||||||95.0|0.7|1.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.00|0.70|
91578008|NCT00461981|183043946|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.51||||||95.0|0.23|1.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.22|0.23|
91578009|NCT00461981|183043947|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.0||||||95.0|4.0|4.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||4.00|4.00|
91578010|NCT00461981|183043948|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.8||||||95.0|0.22|3.63||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.63|0.22|
91578011|NCT00461981|183043949|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.66||||||95.0|0.25|1.73||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.73|0.25|
91578012|NCT00461981|183043954|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
91578013|NCT02383940|183043956|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.207||0.1|TWO_SIDED|95.0|-0.76|0.06||Threshold for significance = 0.05|MMRM||Difference is sotagliflozin - placebo|Between-group comparison was based on MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||0.06|-0.76|0.10
91578014|NCT02672852|183043971|OTHER||Adjusted percentage difference|70.8|||<|0.001|TWO_SIDED|95.0|65.7|76.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||76.0|65.7|< 0.001
91578015|NCT02672852|183043972|OTHER||Adjusted percentage difference|76.5|||<|0.001|TWO_SIDED|95.0|70.4|82.5|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||82.5|70.4|< 0.001
91578016|NCT02672852|183043973|OTHER||Adjusted percentage difference|25.9|||<|0.001|TWO_SIDED|95.0|17.3|34.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||34.6|17.3|< 0.001
91578017|NCT02672852|183043974|OTHER||Adjusted percentage difference|80.6|||<|0.001|TWO_SIDED|95.0|74.5|86.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||86.6|74.5|< 0.001
91578018|NCT02672852|183043975|OTHER||Adjusted percentage difference|45.5|||<|0.001|TWO_SIDED|95.0|40.3|50.8|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.8|40.3|< 0.001
91578019|NCT02672852|183043976|OTHER||Adjusted percentage difference|44.8|||<|0.001|TWO_SIDED|95.0|39.5|50.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.0|39.5|< 0.001
91578020|NCT02672852|183043977|OTHER||Adjusted percentage difference|62.1|||<|0.001|TWO_SIDED|95.0|56.4|67.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||67.9|56.4|< 0.001
91578021|NCT02672852|183043978|OTHER||Adjusted percentage difference|73.9|||<|0.001|TWO_SIDED|95.0|66.0|81.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||81.9|66.0|< 0.001
91578022|NCT02672852|183043979|OTHER||Adjusted percentage difference|21.2|||<|0.001|TWO_SIDED|95.0|13.7|28.7|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||28.7|13.7|< 0.001
91578023|NCT02672852|183043980|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|24.0|42.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||42.2|24.0|< 0.001
91578024|NCT02672852|183043981|OTHER||Adjusted percentage difference|33.7|||<|0.001|TWO_SIDED|95.0|23.2|44.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||44.2|23.2|< 0.001
91578025|NCT01725126|183044030|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.38|1.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.||1.75|-1.38|
91578026|NCT01725126|183044030|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.08|||||TWO_SIDED|95.0|-0.2|2.36|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.||2.36|-0.20|
91578027|NCT01725126|183044031|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-1.64|1.87|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.||1.87|-1.64|
91578028|NCT01725126|183044031|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-0.24|2.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.||2.75|-0.24|
91578029|NCT01725126|183044032|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-1.694|1.331|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||1.331|-1.694|
91578030|NCT01725126|183044032|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.356|||||TWO_SIDED|95.0|-1.409|0.698|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.698|-1.409|
91578031|NCT01725126|183044032|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.853|||||TWO_SIDED|95.0|-2.232|0.526|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||0.526|-2.232|
91578032|NCT01725126|183044032|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-1.219|||||TWO_SIDED|95.0|-2.447|0.009|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.009|-2.447|
91578033|NCT01725126|183044033|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.155|||||TWO_SIDED|95.0|-1.277|1.587|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B -Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.||1.587|-1.277|
91578034|NCT01725126|183044033|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.524|||||TWO_SIDED|95.0|-1.939|0.892|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.||0.892|-1.939|
91578035|NCT01725126|183044035|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.065|||||TWO_SIDED|95.0|-0.495|0.365|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.||0.365|-0.495|
91578036|NCT01725126|183044035|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.219|||||TWO_SIDED|95.0|-0.91|0.472|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.||0.472|-0.910|
91578037|NCT01725126|183044039|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.046|||||TWO_SIDED|90.0|0.729|1.5008|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.5008|0.7290|
91578038|NCT01725126|183044040|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.0334|||||TWO_SIDED|90.0|0.781|1.3673|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.3673|0.7810|
91578039|NCT01725126|183044042|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.675|||||TWO_SIDED|90.0|0.585|0.779|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.779|0.585|
91578040|NCT01725126|183044043|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.662|||||TWO_SIDED|90.0|0.578|0.757|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.757|0.578|
91578041|NCT02917603|183044048|EQUIVALENCE|Null hypothesis is that there would be no mean difference between baseline and last measure between intervention and control groups with p\<.05|Mean Difference (Net)|0.12|||<|0.009|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean differences between baseline and last measure in the PHQ- 9 score will not differ between groups. Study is powered a two-tailed test of significance, allowing the detection of a significant difference in either direction and the following assumptions: expected difference in PHQ-9 is 5 points, the documented clinically significant effect;78 (2) the variance of scores is 5.33; (3) error protection: α =.10, β = .20 and, (4) anticipated attrition of 15%||||<.009
91578042|NCT02917603|183044049|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.46|||<|0.21|TWO_SIDED||||||t-test, 2 sided|||||||<.21
91578043|NCT02917603|183044050|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|1.02|||<|0.06|TWO_SIDED||||||t-test, 2 sided|||||||<.06
91578044|NCT02917603|183044051|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.23|||<|0.73|TWO_SIDED||||||t-test, 2 sided|||||||<.73
91578045|NCT02406677|183044149|SUPERIORITY||Hazard Ratio (HR)|1.073||||0.3503|TWO_SIDED|95.0|0.925|1.246|||Regression, Cox|Cox proportional hazards model accounting for within hospital clustering using robust standard errors|Usual Care arm is the reference group|||1.246|0.925|0.3503
91578046|NCT02406677|183044150|SUPERIORITY||Odds Ratio (OR)|0.838||||0.026|TWO_SIDED|95.0|0.717|0.979|||Regression, Logistic|Logistic regression model with parameters estimated using GEE to account for within hospital clustering for selected patient characteristics||||0.979|0.717|0.0260
91578047|NCT02406677|183044151|SUPERIORITY||Odds Ratio (OR)|2.035|||<|0.0001|TWO_SIDED|95.0|1.564|2.649|||Regression, Logistic|Logistic regression with GEE to account for within hospital clustering||||2.649|1.564|<0.0001
91578048|NCT02145468|183044162|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.238|TWO_SIDED|95.0|0.91|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.47|0.91|0.238
91578049|NCT02145468|183044163|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.38|||Log Rank||"Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk.~with the treatment compared with placebo."|||1.38|0.90|0.329
91578050|NCT02145468|183044164|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.338|TWO_SIDED|95.0|0.88|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.88|0.338
91578051|NCT02145468|183044164|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.41|TWO_SIDED|95.0|0.88|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.88|0.410
91578052|NCT02145468|183044165|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.472|TWO_SIDED|95.0|0.86|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death, MI or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.38|0.86|0.472
91578053|NCT02145468|183044166|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.91|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of arterial CV events (CV death, MI, SRI-UR or stroke), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.91|
91578054|NCT02145468|183044167|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.505|TWO_SIDED|95.0|0.86|1.36|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of coronary events (CHD death, MI, SRI-UR or any unplanned coronary artery revascularization), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.36|0.86|0.505
91578055|NCT02145468|183044168|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.536|TWO_SIDED|95.0|0.64|1.26|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.26|0.64|0.536
91578056|NCT02145468|183044168|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.69|1.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.24|0.69|0.6
91578057|NCT02145468|183044169|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.356|TWO_SIDED|95.0|0.88|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI or stroke, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.88|0.356
91578058|NCT02145468|183044170|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.39|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI, SRI-UR, stroke or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.39|0.9|0.329
91578059|NCT02145468|183044171|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.285|TWO_SIDED|95.0|0.89|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death, MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.89|0.285
91578060|NCT02145468|183044172|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.401|TWO_SIDED|95.0|0.86|1.46|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.46|0.86|0.401
91578061|NCT02145468|183044173|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.295|TWO_SIDED|95.0|0.89|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death, MI or SRI-UR,Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.89|0.295
91578062|NCT02145468|183044174|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.412|TWO_SIDED|95.0|0.86|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.86|0.412
91578063|NCT02145468|183044175|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469|TWO_SIDED|95.0|0.83|1.49|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, type I (spontaneous) MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.49|0.83|0.469
91578064|NCT02145468|183044176|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.664|TWO_SIDED|95.0|0.78|1.48|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or type I (spontaneous) MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.48|0.78|0.664
91578065|NCT02145468|183044177|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.13|TWO_SIDED|95.0|0.27|1.19|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with first occurrence of definite or probable stent thrombosis, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.19|0.27|0.130
91578066|NCT02145468|183044178|SUPERIORITY||Odds Ratio (OR)|1.03||||0.744|TWO_SIDED|95.0|0.84|1.27|||Wald chi-squared||Odds ratio is estimated using a logistic regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. An odds ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.27|0.84|0.744
91578067|NCT02145468|183044179|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.309|TWO_SIDED|95.0|0.53|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with all-cause mortality, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.53|0.309
91578068|NCT02145468|183044180|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.398|TWO_SIDED|95.0|0.53|1.28|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.28|0.53|0.398
91578069|NCT02145468|183044180|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.264|TWO_SIDED|95.0|0.55|1.18|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.18|0.55|0.264
91578070|NCT02145468|183044181|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.251|TWO_SIDED|95.0|0.47|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CHD death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.47|0.251
91578071|NCT02145468|183044182|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.182|TWO_SIDED|95.0|0.91|1.67|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.67|0.91|0.182
91578072|NCT02145468|183044182|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.158|TWO_SIDED|95.0|0.93|1.58|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.58|0.93|0.158
91578073|NCT02145468|183044183|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.21|TWO_SIDED|95.0|0.85|2.12|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Type I (spontaneous) MI events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.12|0.85|0.21
91578074|NCT02145468|183044184|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.697|TWO_SIDED|95.0|0.58|2.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|SRI-UR events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.24|0.58|0.697
91578075|NCT02145468|183044185|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.883|TWO_SIDED|95.0|0.46|1.96|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Stroke (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.96|0.46|0.883
91578076|NCT02145468|183044186|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.457|TWO_SIDED|95.0|0.54|1.32|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.32|0.54|0.457
91578077|NCT02145468|183044186|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.736|TWO_SIDED|95.0|0.63|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.63|0.736
91578078|NCT02145468|183044187|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.581|TWO_SIDED|95.0|0.77|1.59|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Any unplanned coronary revascularization, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.59|0.77|0.581
91578079|NCT00515723|183044203|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) as the independent variable, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.002
91578080|NCT00515723|183044203|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) and treatment group as independent variables, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.002
91578081|NCT00515723|183044204|SUPERIORITY|||||||0.05||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) as the independent variable, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.05
91578082|NCT00515723|183044204|SUPERIORITY|||||||0.22||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) and treatment group as the independent variables, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.22
91578083|NCT03578887|183044224|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
91514174|NCT04079933|182900464|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.4||||0.4251|TWO_SIDED|95.0|-4.88|2.07|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.07|-4.88|0.4251
91578084|NCT03578887|183044225|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
91578085|NCT00095498|183044239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|||||||van Elteren stratified rank test|||||||0.264
91578086|NCT00095498|183044239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||van Elteren stratified rank test|||||||0.018
91578087|NCT00095498|183044240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||van Elteren Stratified Rank Test|||||||0.032
91578088|NCT00095498|183044240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren Stratified Rank Test|||||||0.180
91578089|NCT00095498|183044241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.602|||||||van Elteren Stratified Rank Test|||||||0.602
91578090|NCT00095498|183044241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||van Elteren Stratified Rank Test|||||||0.181
91578091|NCT00095498|183044242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||van Elteren Stratified Rank Test|||||||0.012
91578092|NCT00095498|183044242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||van Elteren Stratified Rank Test|||||||0.007
91578093|NCT00095498|183044243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277|||||||van Elteren Stratified Rank Test|||||||0.277
91578094|NCT00095498|183044243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||van Elteren Stratified Rank Test|||||||0.019
91578095|NCT00095498|183044244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.382|||||||van Elteren Stratified Rank Test|||||||0.382
91578096|NCT00095498|183044244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.488|||||||van Elteren Stratified Rank Test|||||||0.488
91578097|NCT00095498|183044245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|||||||van Elteren Stratified Rank Test|||||||0.236
91578098|NCT00095498|183044245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712|||||||van Elteren Stratified Rank Test|||||||0.712
91578099|NCT00095498|183044246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||0.026||95.0|0.11|1.74|||Repeated Measures Model|||||1.74|0.11|0.026
91578100|NCT00095498|183044246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59||||0.155||95.0|-0.23|1.41|||Repeated measures model|||||1.41|-0.23|0.155
91578101|NCT00095498|183044247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.67||||0.002||95.0|0.62|2.72|||Repeated Measures Model|||||2.72|0.62|0.002
91578102|NCT00095498|183044247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||<|0.001||95.0|0.84|2.94|||Repeated Measures Model|||||2.94|0.84|<0.001
91578103|NCT00095498|183044248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.001||95.0|1.1|3.29|||Repeated Measures Model|||||3.29|1.1|<0.001
91578104|NCT00095498|183044248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29|||<|0.001||95.0|2.18|4.39|||Repeated Measures Model|||||4.39|2.18|<0.001
91578105|NCT00095498|183044249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.986||95.0|-1.06|1.08|||Repeated Measures Model|||||1.08|-1.06|0.986
91578106|NCT00095498|183044249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.141||95.0|-0.27|1.86|||Repeated Measures Model|||||1.86|-0.27|0.141
91578107|NCT00095498|183044250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.95||||0.073||95.0|-0.09|1.99|||Repeated Measures Model|||||1.99|-0.09|0.073
91578108|NCT00095498|183044250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89||||0.09||95.0|-0.14|1.93|||Repeated Measures Model|||||1.93|-0.14|0.09
91578109|NCT00095498|183044251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.007||95.0|0.51|3.12|||Repeated Measures Model|||||3.12|0.51|0.007
91578110|NCT00095498|183044251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98||||0.003||95.0|0.67|3.29|||Repeated Measures Model|||||3.29|0.67|0.003
91578111|NCT00095498|183044252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.938||95.0|-0.58|0.63|||Repeated Measures Model|||||0.63|-0.58|0.938
91578112|NCT00095498|183044252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08||||0.787||95.0|-0.53|0.69|||Repeated Measures Model|||||0.69|-0.53|0.787
91578113|NCT00095498|183044253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.004||95.0|0.33|1.67|||Repeated Measures Model|||||1.67|0.33|0.004
91578114|NCT00095498|183044253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|||<|0.001||95.0|0.51|1.85|||Repeated Measures Model|||||1.85|0.51|<0.001
91578115|NCT00095498|183044254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.94|||<|0.001||95.0|1.02|2.85|||Repeated Measures Model|||||2.85|1.02|<0.001
91578116|NCT00095498|183044254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.04|||<|0.001||95.0|1.13|2.96|||Repeated Measures Model|||||2.96|1.13|<0.001
91578117|NCT00095498|183044255|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578118|NCT00095498|183044255|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578119|NCT00095498|183044256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578120|NCT00095498|183044256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578121|NCT00095498|183044257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578122|NCT00095498|183044257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578123|NCT00095498|183044258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578124|NCT00095498|183044258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578125|NCT00095498|183044259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578126|NCT00095498|183044259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578127|NCT00095498|183044260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||van Elteren Stratified Rank Test|||||||0.016
91578128|NCT00095498|183044260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578129|NCT00095498|183044261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578130|NCT00095498|183044261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
91578131|NCT00095498|183044262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||van Elteren Stratified Rank Test|||||||0.673
91578132|NCT00095498|183044262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.589|||||||van Elteren Stratified Rank Test|||||||0.589
91578133|NCT00095498|183044263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||van Elteren Stratified Rank Test|||||||0.175
91578134|NCT00095498|183044263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||van Elteren Stratified Rank Test|||||||0.133
91578135|NCT00926497|183044406|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.||||0.002
91578136|NCT00926497|183044407|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
91578137|NCT00926497|183044407|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
91578138|NCT03439254|183044409|OTHER||Response ratio(Mantel-Haenszel estimate)|1.13||||0.6172|TWO_SIDED|95.0|0.71|1.79|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.79|0.71|0.6172
91578139|NCT03439254|183044409|OTHER||Response ratio(Mantel-Haenszel estimate)|1.2||||0.4184|TWO_SIDED|95.0|0.77|1.89|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.89|0.77|0.4184
91578140|NCT00128102|183044425|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.83|1.17|||Log Rank|||||1.17|0.83|0.858
91578141|NCT00128102|183044429|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Likelihood Based Score Test|||||0.88|0.63|<0.001
91578142|NCT00128102|183044430|SUPERIORITY||Difference in Percentage|0.3||||0.621|TWO_SIDED|95.0|-1.18|1.97|||Fisher Exact|||||1.97|-1.18|0.621
91578143|NCT00128102|183044431|SUPERIORITY||Difference in Percent Change|-52.4||||0.259|TWO_SIDED|95.0|-143.5|38.6|||Longitudinal Model|||||38.6|-143.5|0.259
91578144|NCT00128102|183044432|SUPERIORITY||Difference in Percentage|-1.3||||0.736|TWO_SIDED|95.0|-7.2|4.53|||Fisher Exact|||||4.53|-7.20|0.736
91578145|NCT00128102|183044433|SUPERIORITY||Difference in Percent Change|-0.06||||0.979|TWO_SIDED|95.0|-4.61|4.49|||Longitudinal Model|||||4.49|-4.61|0.979
91578146|NCT00128102|183044434|SUPERIORITY||Difference in Percentage|3.1||||0.488|TWO_SIDED|95.0|-4.97|11.17|||Fisher Exact|||||11.17|-4.97|0.488
91578147|NCT01531673|183044436|SUPERIORITY||Least Squares (LS) Mean Difference|4.77||||0.0647|TWO_SIDED|95.0|-0.3|9.84|||Mixed-effect repeated measure (MMRM)|||||9.84|-0.3|0.0647
91578148|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-3.91||||0.1686|TWO_SIDED|95.0|-9.5|1.68|||MMRM|||||1.68|-9.5|0.1686
91578149|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-4.2||||0.0348|TWO_SIDED|95.0|-8.1|-0.31|||MMRM|||||-0.31|-8.1|0.0348
91578150|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-19.58|||<|0.0001|TWO_SIDED|95.0|-24.57|-14.59|||MMRM|||||-14.59|-24.57|<0.0001
91578151|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-5.14||||0.0101|TWO_SIDED|95.0|-9.03|-1.25|||MMRM|||||-1.25|-9.03|0.0101
91578152|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-5.19||||0.011|TWO_SIDED|95.0|-9.16|-1.21|||MMRM|||||-1.21|-9.16|0.011
91578153|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-9.6||||0.0001|TWO_SIDED|95.0|-14.38|-4.82|||MMRM|||||-4.82|-14.38|0.0001
91578154|NCT01531673|183044436|SUPERIORITY||LS Mean Difference|-1.77||||0.3745|TWO_SIDED|95.0|-5.71|2.17|||MMRM|||||2.17|-5.71|0.3745
91578155|NCT01531673|183044437|SUPERIORITY||LS Mean Difference|-6.7||||0.0357|TWO_SIDED|95.0|-12.94|-0.46|||MMRM|||||-0.46|-12.94|0.0357
91578156|NCT01531673|183044438|SUPERIORITY||LS Mean Difference|-17.2||||0.0238|TWO_SIDED|95.0|-31.75|-2.65|||MMRM|||||-2.65|-31.75|0.0238
91578157|NCT00568178|183044453|SUPERIORITY_OR_OTHER_LEGACY||Ratio in Geometric Mean|0.63||||0.001|TWO_SIDED|95.0|0.54|0.74|||Mixed Models Analysis|||||0.74|0.54|0.001
91578158|NCT00568178|183044454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||||95.0|-9.9|-1.0|||Mixed Models Analysis|||||-1.0|-9.9|
91578159|NCT00568178|183044455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6||||||95.0|-9.2|-0.1|||Mixed Models Analysis|||||-0.1|-9.2|
91578160|NCT00568178|183044456|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio|1.18|||||TWO_SIDED|95.0|0.86|1.6||No P Value was calculated for this outcome.|Mixed Models Analysis|An unstructured variance-covariance was used.||||1.60|0.86|
91578161|NCT00568178|183044457|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-3.8||||||95.0|-15.2|7.6||A P-Value was not calculated for this outcome.|Mixed Models Analysis|||||7.6|-15.2|
91578162|NCT01014208|183044458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.333|TWO_SIDED|95.0|0.89|1.42||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-rank test||The Pike estimator was the statistical method used to estimate the hazard ratio.|||1.42|0.89|0.333
91578163|NCT01014208|183044459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4053|TWO_SIDED|95.0|0.56|1.24||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||1.24|0.56|0.4053
91578164|NCT01014208|183044459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1167|TWO_SIDED|95.0|0.39|1.1||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||1.10|0.39|0.1167
91578165|NCT01014208|183044460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.8209|TWO_SIDED|95.0|0.55|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||2.43|0.55|0.8209
91578166|NCT01014208|183044460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6313|TWO_SIDED|95.0|0.62|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||2.43|0.62|0.6313
91578167|NCT01014208|183044461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.346|TWO_SIDED|95.0|0.9|1.36||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.36|0.90|0.346
91578168|NCT01014208|183044462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.377|TWO_SIDED|95.0|0.7|1.15||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.15|0.70|0.377
91578169|NCT01014208|183044463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.1161|TWO_SIDED|95.0|0.83|9.5||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel|||||9.50|0.83|0.1161
91578170|NCT01014208|183044464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4481|TWO_SIDED|95.0|0.56|1.27||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||Statistics are presented for Completion rate|||1.27|0.56|0.4481
91578171|NCT01014208|183044465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.978|TWO_SIDED|95.0|-2.11|2.17|||ANCOVA|||||2.170|-2.110|0.978
91578172|NCT01014208|183044466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.129||||0.387|TWO_SIDED|95.0|-1.434|3.691|||ANCOVA|||||3.691|-1.434|0.387
91578173|NCT01014208|183044467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.479|TWO_SIDED|95.0|0.74|1.16||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.16|0.74|0.479
91578174|NCT01014208|183044467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.059|TWO_SIDED|95.0|0.64|1.02||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.02|0.64|0.059
91578175|NCT01014208|183044467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.451|TWO_SIDED|95.0|0.83|1.48||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.48|0.83|0.451
91578176|NCT01014208|183044467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.597|TWO_SIDED|95.0|0.86|1.29||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.29|0.86|0.597
91578177|NCT01014208|183044467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.199|TWO_SIDED|95.0|0.7|1.1||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.10|0.70|0.199
91578178|NCT01014208|183044467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.102|TWO_SIDED|95.0|0.93|1.59||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.59|0.93|0.102
91578179|NCT01014208|183044468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.035|TWO_SIDED|95.0|0.36|1.0||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.00|0.36|0.035
91578180|NCT01008553|183044477|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Log Rank|||||||0.0003
91578181|NCT01008410|183044506|SUPERIORITY|||||||0.0324||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||0.0324
91578182|NCT00297427|183044517|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
91578183|NCT00297427|183044518|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
91578184|NCT00297427|183044519|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.16
91578185|NCT00297427|183044520|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
91578186|NCT00297427|183044522|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
91578187|NCT00297427|183044523|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
91578188|NCT00297427|183044524|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
91578189|NCT00297427|183044526|SUPERIORITY_OR_OTHER|||||||0.04|||||||Repeated measures using GEE|||||||0.04
91578190|NCT00297427|183044527|SUPERIORITY_OR_OTHER|||||||0.01|||||||Repeated measures using GEE|||||||0.01
91578191|NCT00297427|183044528|SUPERIORITY_OR_OTHER|||||||0.41|||||||Repeated measures using GEE|||||||0.41
91578192|NCT00297427|183044529|SUPERIORITY_OR_OTHER|||||||0.04||||||Bivariate (unadjusted) analysis|t-test, 2 sided|||||||0.04
91578193|NCT00297427|183044529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.208||||0.014|TWO_SIDED|95.0|1.039|1.405|||Regression, Logistic||These are the adjusted results of a multivariate logistic regression.|||1.405|1.039|0.014
91578194|NCT00297427|183044530|SUPERIORITY_OR_OTHER|||||||0.023||||||This is the result from the bivariate (unadjusted) analysis.|t-test, 2 sided|||||||0.023
91578195|NCT00297427|183044530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.03|TWO_SIDED|95.0|0.881|0.994|||Regression, Logistic||These are the adjusted results from a multivariate logistic regression analysis.|||0.994|0.881|0.030
91578196|NCT00297427|183044531|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
91578197|NCT00297427|183044532|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
91578198|NCT00297427|183044534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<.001
91578199|NCT00297427|183044535|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
91578200|NCT00297427|183044536|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||||||0.86
91578201|NCT01262677|183044559|SUPERIORITY||Mean Difference|-0.99||||0.9076|TWO_SIDED|95.0|-16.28|17.11||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||17.11|-16.28|0.9076
91578202|NCT01262677|183044559|SUPERIORITY||Mean Difference|-13.05||||0.0907|TWO_SIDED|95.0|-26.07|2.25||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||2.25|-26.07|0.0907
91578203|NCT01262677|183044560|SUPERIORITY|||||||0.752||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.752
91578204|NCT01262677|183044560|SUPERIORITY|||||||0.125||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.125
91578205|NCT01262677|183044561|SUPERIORITY||LS Mean Difference|-9.3||||0.5404|TWO_SIDED|95.0|-39.16|20.56||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||20.56|-39.16|0.5404
91578206|NCT01262677|183044561|SUPERIORITY||LS Mean Difference|-25.84||||0.0786|TWO_SIDED|95.0|-54.64|2.97||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||2.97|-54.64|0.0786
91578207|NCT01262677|183044562|SUPERIORITY||LS Mean Difference|-0.11||||0.6073|TWO_SIDED|95.0|-0.53|0.31||Statistical testing was done at alpha = 0.05 level, two-sided.|Generalized linear model (GLM)|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.31|-0.53|0.6073
91578208|NCT01262677|183044562|SUPERIORITY||LS Mean Difference|-0.16||||0.4109|TWO_SIDED|95.0|-0.53|0.22||Statistical testing was done at alpha = 0.05 level, two-sided.|GLM|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.22|-0.53|0.4109
91578209|NCT01262677|183044563|SUPERIORITY||LS Mean Difference|-1.38||||0.8268|TWO_SIDED|95.0|-12.97|11.75||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||11.75|-12.97|0.8268
91578210|NCT01262677|183044563|SUPERIORITY||LS Mean Difference|0.75||||0.9024|TWO_SIDED|95.0|-10.69|13.66||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||13.66|-10.69|0.9024
91578211|NCT01262677|183044564|SUPERIORITY|||||||0.67||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.670
91578212|NCT01262677|183044564|SUPERIORITY|||||||0.927||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.927
91578213|NCT01262677|183044565|SUPERIORITY||LS Mean Difference|2.28||||0.8034|TWO_SIDED|95.0|-14.37|22.15||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||22.15|-14.37|0.8034
91578214|NCT01262677|183044565|SUPERIORITY||LS Mean Difference|-10.78||||0.1905|TWO_SIDED|95.0|-24.81|5.87||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.87|-24.81|0.1905
91578215|NCT01262677|183044566|SUPERIORITY||LS Mean Difference|-0.3||||0.465|TWO_SIDED|95.0|-1.1|0.5||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.5|-1.1|0.4650
91578216|NCT01262677|183044566|SUPERIORITY||LS Mean Difference|0.0||||0.9692|TWO_SIDED|95.0|-0.8|0.8||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.8|-0.8|0.9692
91578217|NCT01262677|183044567|SUPERIORITY||LS Mean Difference|-0.5||||0.2693|TWO_SIDED|95.0|-1.3|0.4||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.4|-1.3|0.2693
91578218|NCT01262677|183044567|SUPERIORITY||LS Mean Difference|-0.5||||0.1893|TWO_SIDED|95.0|-1.4|0.3||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.3|-1.4|0.1893
91578219|NCT01262677|183044568|SUPERIORITY||LS Mean Difference|-0.8||||0.7347|TWO_SIDED|95.0|-5.2|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-5.2|0.7347
91578220|NCT01262677|183044568|SUPERIORITY||LS Mean Difference|0.3||||0.8971|TWO_SIDED|95.0|-4.0|4.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.6|-4.0|0.8971
91578221|NCT01262677|183044569|SUPERIORITY||LS Mean Difference|-2.7||||0.3972|TWO_SIDED|95.0|-9.1|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-9.1|0.3972
91578222|NCT01262677|183044569|SUPERIORITY||LS Mean Difference|6.7||||0.0319|TWO_SIDED|95.0|0.6|12.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||12.9|0.6|0.0319
91578223|NCT01262677|183044570|SUPERIORITY||LS Mean Difference|0.8||||0.7708|TWO_SIDED|95.0|-4.4|5.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.9|-4.4|0.7708
91578224|NCT01262677|183044570|SUPERIORITY||LS Mean Difference|2.4||||0.356|TWO_SIDED|95.0|-2.7|7.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||7.4|-2.7|0.3560
91578225|NCT01262677|183044571|SUPERIORITY||LS Mean Difference|0.2||||0.1129|TWO_SIDED|95.0|-0.1|0.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.5|-0.1|0.1129
91578226|NCT01262677|183044571|SUPERIORITY||LS Mean Difference|0.0||||0.9388|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.3|-0.3|0.9388
91578227|NCT01262677|183044572|SUPERIORITY||LS Mean Difference|-0.4||||0.9053|TWO_SIDED|95.0|-7.5|6.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||6.6|-7.5|0.9053
91578228|NCT01262677|183044572|SUPERIORITY||LS Mean Difference|-1.6||||0.6371|TWO_SIDED|95.0|-8.5|5.2||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.2|-8.5|0.6371
91578229|NCT01262677|183044573|SUPERIORITY||LS Mean Difference|-6.4||||0.0119|TWO_SIDED|95.0|-11.4|-1.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||-1.4|-11.4|0.0119
91578230|NCT01262677|183044573|SUPERIORITY||LS Mean Difference|0.0||||0.9909|TWO_SIDED|95.0|-4.9|4.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.8|-4.9|0.9909
91578231|NCT01262677|183044574|SUPERIORITY||LS Mean Difference|-1.1||||0.5903|TWO_SIDED|95.0|-5.0|2.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||2.8|-5.0|0.5903
91578232|NCT01262677|183044574|SUPERIORITY||LS Mean Difference|0.7||||0.7126|TWO_SIDED|95.0|-3.1|4.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.5|-3.1|0.7126
91578233|NCT01262677|183044575|SUPERIORITY||LS Mean Difference|-2.1||||0.2431|TWO_SIDED|95.0|-5.8|1.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||1.5|-5.8|0.2431
91578234|NCT01262677|183044575|SUPERIORITY||LS Mean Difference|0.3||||0.8654|TWO_SIDED|95.0|-3.2|3.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.8|-3.2|0.8654
91578235|NCT01262677|183044576|SUPERIORITY||Odds Ratio (OR)|1.36||||0.3241|TWO_SIDED|95.0|0.74|2.5||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||2.50|0.74|0.3241
91578236|NCT01262677|183044576|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8932|TWO_SIDED|95.0|0.54|1.71||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||1.71|0.54|0.8932
91578237|NCT00574873|183044587|SUPERIORITY_OR_OTHER|||||||0.667||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.667
91578238|NCT00574873|183044588|SUPERIORITY_OR_OTHER|||||||0.002||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.002
91578239|NCT00574873|183044589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.31|0.31|
91578240|NCT00574873|183044590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.32|1.08|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.08|0.32|
91578241|NCT00574873|183044591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.25|||||TWO_SIDED|95.0|0.9|11.72|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||11.72|0.90|
91578242|NCT00574873|183044592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.13|1.29|||||The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.|||1.29|0.13|
91578243|NCT00581555|183044593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.5||0.999|TWO_SIDED|95.0|-14.7|14.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 8.||14.7|-14.7|0.999
91578244|NCT00581555|183044593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|7.5||0.795|TWO_SIDED|95.0|-12.8|16.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 10.||16.7|-12.8|0.795
91578245|NCT00581555|183044593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|7.6||0.758|TWO_SIDED|95.0|-12.5|17.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 12.||17.1|-12.5|0.758
91578246|NCT00581555|183044593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|7.6||0.381|TWO_SIDED|95.0|-8.3|21.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 16.||21.6|-8.3|0.381
91578247|NCT00581555|183044593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|7.8||0.041|TWO_SIDED|95.0|0.8|31.4||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis at randomization to Week 20.||31.4|0.8|0.041
91578248|NCT00581555|183044593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.5|STANDARD_ERROR_OF_MEAN|8.0|<|0.001|TWO_SIDED|95.0|14.8|46.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 24.||46.3|14.8|<0.001
91578249|NCT00581555|183044594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.049|TWO_SIDED|95.0|0.0|1.2||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||1.2|0.0|0.049
91578250|NCT00581555|183044595|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from randomization to Week 24.||||0.002
91578251|NCT00581555|183044596|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Log Rank|Time to first relapse was estimated using the Kaplan-Meier's, and comparisons between groups was performed using log rank tests.||||||0.0003
91578252|NCT00581555|183044597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|2.1|7.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||7.3|2.1|<0.001
91578253|NCT00581555|183044598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|135.2|STANDARD_ERROR_OF_MEAN|42.3||0.001|TWO_SIDED|95.0|52.3|218.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||218.1|52.3|0.001
91578254|NCT00581555|183044599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.6||0.139||95.0|-0.8|5.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||5.5|-0.8|0.139
91578255|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.956|TWO_SIDED|95.0|-2.3|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 2.||2.5|-2.3|0.956
91578256|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.41|TWO_SIDED|95.0|-3.6|1.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 4.||1.5|-3.6|0.41
91578257|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.2||0.844|TWO_SIDED|95.0|-4.8|3.9||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 6.||3.9|-4.8|0.844
91578258|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.968|TWO_SIDED|95.0|-1.8|1.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 8.||1.8|-1.8|0.968
91578259|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.441|TWO_SIDED|95.0|-1.1|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 10.||2.5|-1.1|0.441
91578260|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED|95.0|-0.9|2.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 12.||2.8|-0.9|0.3
91578261|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|0.7|4.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 16.||4.5|0.7|0.008
91578262|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|1.0||0.005|TWO_SIDED|95.0|0.9|5.0||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 20.||5.0|0.9|0.005
91578263|NCT00581555|183044600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.1||0.031|TWO_SIDED|95.0|0.2|4.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 24.||4.6|0.2|0.031
91578264|NCT00581555|183044601|SUPERIORITY_OR_OTHER|||||||0.1196||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square or Fisher exact test|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from baseline to Week 24.||||0.1196
91578265|NCT02787044|183044602|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.21|TWO_SIDED|95.0|0.97|1.17|||Regression, Cox|||Note, each participant can be included in the primary analysis up to 3 times (participating seasons).||1.17|0.97|0.21
91578266|NCT02787044|183044603|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox|||||1.15|0.94|0.44
91578267|NCT02787044|183044604|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.16|TWO_SIDED|95.0|0.97|1.2|||Regression, Cox|||Each participant can be analyzed up to three times (seasons)||1.2|.97|0.16
91578268|NCT02787044|183044605|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.26|TWO_SIDED|95.0|0.96|1.15|||Regression, Cox|||||1.15|.96|0.26
91578269|NCT02787044|183044606|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.84|1.21|||Regression, Cox|||||1.21|0.84|0.96
91578270|NCT01638429|183044608|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.16
91578271|NCT01638429|183044610|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.028
91578272|NCT01638429|183044611|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.01
91578273|NCT01638429|183044612|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.97
91578274|NCT01638429|183044612|SUPERIORITY_OR_OTHER|||||||0.85|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.85
91578275|NCT01638429|183044613|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.61
91578276|NCT01638429|183044613|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.45
91578277|NCT01638429|183044614|SUPERIORITY_OR_OTHER|||||||0.018|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.018
91578278|NCT01638429|183044614|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.14
91578279|NCT01638429|183044615|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.43
91578280|NCT01638429|183044615|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.44
91578281|NCT01638429|183044616|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.13
91578282|NCT01638429|183044616|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.25
91578283|NCT01638429|183044617|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.29
91578284|NCT01638429|183044617|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.27
91578285|NCT01638429|183044618|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.22
91578286|NCT01638429|183044618|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.059
91578287|NCT01638429|183044619|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.33
91578288|NCT01638429|183044619|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.075
91578289|NCT02040584|183044620|SUPERIORITY_OR_OTHER|||||||0.9423|||||||Fisher Exact|Week 52||"Null hypothesis (H0): there were no differences in kidney function between the two groups, in contrast with the alternative hypothesis (H1), in which there were differences:~HO: CBS = CBC versus H1: CBS ≠ CBC, where CBS and CBC were percentages of patients who showed clinical benefit at Week 52 for the study group and control group, respectively."||||0.9423
91578290|NCT00731133|183044638|SUPERIORITY_OR_OTHER||Slope|2.6466|STANDARD_ERROR_OF_MEAN|0.9016||0.05|TWO_SIDED|95.0|0.7858|4.5073|||Mixed Models Analysis|7,24||Open-label study testing for change in side-effects ratings over time (i.e., slope).||4.5073|.7858|0.05
91578291|NCT00731133|183044639|SUPERIORITY_OR_OTHER||Slope|-0.373|STANDARD_ERROR_OF_MEAN|0.2196||0.05|TWO_SIDED|95.0|-0.8075|0.0615|||Mixed Models Analysis|7,24||Open label study testing changes in amphetamine use over time (i.e., slope).||0.06150|-0.8075|0.05
91578292|NCT00943852|183044640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
91578293|NCT00943852|183044641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
91578294|NCT03098563|183044642|SUPERIORITY|||||||0.021|||||||ANOVA|||||||.021
91578295|NCT04978493|183044774|OTHER||Difference of adjusted means|1.92|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-0.99|4.84|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||4.84|-0.99|
91578296|NCT04978493|183044775|OTHER||Difference of adjusted means|13.34|STANDARD_ERROR_OF_MEAN|11.32|||TWO_SIDED|95.0|-9.46|36.14|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||36.14|-9.46|
91578297|NCT04978493|183044776|OTHER||Unadjusted risk difference|-27.5|||||TWO_SIDED|95.0|-48.42|-2.64|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||-2.64|-48.42|
91578298|NCT04978493|183044777|OTHER||Unadjusted risk difference|0.67|||||TWO_SIDED|95.0|-20.49|22.12|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||22.12|-20.49|
91578299|NCT04978493|183044778|OTHER||Unadjusted risk difference|-3.83|||||TWO_SIDED|95.0|-21.14|13.25|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||13.25|-21.14|
91578300|NCT04978493|183044779|OTHER||Unadjusted risk difference|0.33|||||TWO_SIDED|95.0|-17.67|18.78|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.78|-17.67|
91578301|NCT04978493|183044780|OTHER||Unadjusted risk difference|-3.33|||||TWO_SIDED|95.0|-24.91|18.85|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.85|-24.91|
91578302|NCT04978493|183044781|OTHER||Unadjusted risk difference|-3.5|||||TWO_SIDED|95.0|-23.86|17.34|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||17.34|-23.86|
91578303|NCT04978493|183044782|OTHER||Unadjusted risk difference|-18.5|||||TWO_SIDED|95.0|-42.32|8.89|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||8.89|-42.32|
91578304|NCT04978493|183044783|OTHER||Unadjusted risk difference|0.83|||||TWO_SIDED|95.0|-21.53|23.41|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||23.41|-21.53|
91578305|NCT04978493|183044784|OTHER||Unadjusted risk difference|-22.17|||||TWO_SIDED|95.0|-45.42|5.19|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||5.19|-45.42|
91578306|NCT00798434|183044827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.12|-0.97|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.||Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).||-0.97|-2.12|<0.0001
91578307|NCT00798434|183044828|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.44|||<|0.0001|TWO_SIDED|95.0|-14.67|-14.25|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and confidence interval (CI)|Week 12 LOCF||-14.25|-14.67|<0.0001
91578308|NCT00798434|183044829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.22||0.0001|TWO_SIDED|95.0|-1.28|-0.42|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes||Week 12 LOCF||-0.42|-1.28|0.0001
91578309|NCT00798434|183044830|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0005|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.0005
91578310|NCT00798434|183044831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.33|-0.64|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions||Week 12 LOCF||-0.64|-1.33|<0.0001
91578311|NCT00798434|183044832|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.31|||<|0.0001|TWO_SIDED|95.0|-7.4|-7.19|||2-sided Van Elteren's test|||Week 12 LOCF||-7.19|-7.40|<0.0001
91578312|NCT00798434|183044833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0026|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions||Week 12 LOCF||-0.09|-0.40|0.0026
91578313|NCT00798434|183044834|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.52||||0.0012|TWO_SIDED|95.0|-9.52|-9.09|||2-sided Van Elteren's test|||Week 12 LOCF||-9.09|-9.52|0.0012
91578314|NCT00798434|183044835|SUPERIORITY_OR_OTHER||Hodges-Lehman estimate|0.0||||0.1005|TWO_SIDED|95.0|0.0|0.0||The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.|Van-Elteren's Test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.1005
91578315|NCT00798434|183044836|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0218|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test|||Week 12 LOCF||0.00|0.00|0.0218
91578316|NCT00798434|183044837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.3|-3.1|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline||Week 12 LOCF||-3.10|-6.30|<0.0001
91578317|NCT00798434|183044838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.515||||0.1113|TWO_SIDED|95.0|0.909|2.528||Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.|Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||LOCF||2.528|0.909|0.1113
91578318|NCT00798434|183044839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11||0.023|TWO_SIDED|95.0|-0.47|-0.04|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours||Incontinence pads at Week 12 LOCF||-0.04|-0.47|0.0230
91578319|NCT00798434|183044839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0909|TWO_SIDED|95.0|-0.12|0.01|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours||Creams at Week 12 LOCF||0.01|-0.12|0.0909
91578320|NCT00798434|183044839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2039|TWO_SIDED|95.0|-0.08|0.02|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours||Powder at Week 12 LOCF||0.02|-0.08|0.2039
91578321|NCT00798434|183044840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.096|||<|0.0001|TWO_SIDED|95.0|2.181|4.395|||Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||Week 12 LOCF||4.395|2.181|<0.0001
91578322|NCT00798434|183044843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506|||<|0.0001|TWO_SIDED|95.0|1.767|3.556||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPBC category||Week 12 LOCF||3.556|1.767|<0.0001
91578323|NCT00798434|183044847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.0009|TWO_SIDED|95.0|1.305|2.811||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPUS category||LOCF||2.811|1.305|0.0009
91578324|NCT00798434|183044849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-9.65|-4.59|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score||Week 12 LOCF||-4.59|-9.65|<0.0001
91578325|NCT00798434|183044850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.48|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|2.24|6.73|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.||Week 12 LOCF||6.73|2.24|<0.0001
91578326|NCT00798434|183044851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.44||0.0002|TWO_SIDED|95.0|2.57|8.22|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Coping Subscale at Week 12; LOCF||8.22|2.57|0.0002
91578327|NCT00798434|183044851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|2.84|7.93|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Concern Subscale at Week 12; LOCF||7.93|2.84|<0.0001
91578328|NCT00798434|183044851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.38||0.0032|TWO_SIDED|95.0|1.38|6.81|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Sleep Subscale at Week 12; LOCF||6.81|1.38|0.0032
91578329|NCT00798434|183044851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.03||0.0152|TWO_SIDED|95.0|0.49|4.53|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Social Subscale at Week 12; LOCF||4.53|0.49|0.0152
91578330|NCT00798434|183044852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.537|||<|0.001|TWO_SIDED|95.0|2.281|5.484||Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||5.484|2.281|<0.001
91578331|NCT00798434|183044853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|2.045|4.058||Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||4.058|2.045|<0.0001
91578332|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|4.12||0.3163|TWO_SIDED|95.0|-4.13|12.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||General Health Perception; LOCF||12.49|-4.13|0.3163
91578333|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|8.63||0.4698|TWO_SIDED|95.0|-23.7|11.11|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Incontinence Impact; LOCF||11.11|-23.70|0.4698
91578334|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|9.28||0.5321|TWO_SIDED|95.0|-24.58|12.88|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Role Limitations; LOCF||12.88|-24.58|0.5321
91578335|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|8.39||0.6523|TWO_SIDED|95.0|-20.74|13.12|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Physical Limitations; LOCF||13.12|-20.74|0.6523
91578336|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|6.8||0.6344|TWO_SIDED|95.0|-10.47|16.99|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Social Limitations; LOCF||16.99|-10.47|0.6344
91578337|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|STANDARD_ERROR_OF_MEAN|8.38||0.2013|TWO_SIDED|95.0|-28.71|6.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Personal Relationships; LOCF||6.49|-28.71|0.2013
91578338|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|6.88||0.3831|TWO_SIDED|95.0|-19.96|7.83|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Emotions; LOCF||7.83|-19.96|0.3831
91578339|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|6.82||0.5167|TWO_SIDED|95.0|-9.3|18.23|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Sleep/Energy; LOCF||18.23|-9.30|0.5167
91578340|NCT00798434|183044854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.19|STANDARD_ERROR_OF_MEAN|5.12||0.0532|TWO_SIDED|95.0|-20.53|0.15|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Severity of Urinary Symptoms; LOCF||0.15|-20.53|0.0532
91578341|NCT00798434|183044855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0016|STANDARD_ERROR_OF_MEAN|0.0125||0.8959|TWO_SIDED|95.0|-0.0229|0.0262|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline single utility score||||0.0262|-0.0229|0.8959
91578342|NCT00558792|183044888|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||Chi-squared|||||||0.0099
91578343|NCT00558792|183044889|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
91578344|NCT00558792|183044890|SUPERIORITY_OR_OTHER|||||||0.1212||95.0|||||Chi-squared|||||||0.1212
91578345|NCT00558792|183044892|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.0200
91578346|NCT00558792|183044893|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANOVA|||||||0.0044
91578347|NCT00558792|183044894|SUPERIORITY_OR_OTHER|||||||0.0371||95.0|||||ANOVA|||||||0.0371
91578348|NCT00558792|183044895|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|14.1||||0.2758|TWO_SIDED|95.0|-11.4|39.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||39.6|-11.4|0.2758
91578349|NCT00558792|183044895|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|12.3||||0.3102|TWO_SIDED|95.0|-11.1|35.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.6|-11.1|0.3102
91578350|NCT00558792|183044895|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|1.9||||0.8893|TWO_SIDED|95.0|-24.6|28.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||28.4|-24.6|0.8893
91578351|NCT00558792|183044896|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.7||||0.2511|TWO_SIDED|95.0|-4.7|1.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.3|-4.7|0.2511
91578352|NCT00558792|183044896|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|1.3||||0.4985|TWO_SIDED|95.0|-2.6|5.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||5.3|-2.6|0.4985
91578353|NCT00558792|183044896|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.1||||0.0693|TWO_SIDED|95.0|-6.5|0.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.4|-6.5|0.0693
91578354|NCT00558792|183044897|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-1.5||||0.9104|TWO_SIDED|95.0|-27.9|24.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||24.8|-27.9|0.9104
91578355|NCT00558792|183044897|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-12.6||||0.2857|TWO_SIDED|95.0|-35.7|10.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||10.5|-35.7|0.2857
91578356|NCT00558792|183044897|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|11.1||||0.3664|TWO_SIDED|95.0|-13.3|35.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.5|-13.3|0.3664
91578357|NCT00558792|183044898|SUPERIORITY_OR_OTHER||Difference in Specifcity between Doses|-3.7||||0.1322|TWO_SIDED|95.0|-8.7|1.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.2|-8.7|0.1322
91578358|NCT00558792|183044898|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.3||||0.6381|TWO_SIDED|95.0|-6.9|4.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.2|-6.9|0.6381
91578359|NCT00558792|183044898|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-2.4||||0.3217|TWO_SIDED|95.0|-7.2|2.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||2.4|-7.2|0.3217
91578360|NCT00558792|183044899|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|7.6||||0.5843|TWO_SIDED|95.0|-19.6|34.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||34.7|-19.6|0.5843
91578361|NCT00558792|183044899|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|4.6||||0.7197|TWO_SIDED|95.0|-20.5|29.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||29.7|-20.5|0.7197
91578362|NCT00558792|183044899|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|3.0||||0.8292|TWO_SIDED|95.0|-24.1|30.1||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||30.1|-24.1|0.8292
91578363|NCT00558792|183044900|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-4.2||||0.0888|TWO_SIDED|95.0|-9.0|0.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.7|-9.0|0.0888
91578364|NCT00558792|183044900|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-0.8||||0.7796|TWO_SIDED|95.0|-6.4|4.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.8|-6.4|0.7796
91578365|NCT00558792|183044900|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.4||||0.1662|TWO_SIDED|95.0|-8.2|1.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.5|-8.2|0.1662
91578366|NCT04893460|183044999|SUPERIORITY|This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Cost activity|Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.33||0.003|TWO_SIDED||||||t-test, 2 sided|||||||.003
91578367|NCT04893460|183044999|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Quit Letter activity||||<.001
91578368|NCT04893460|183044999|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.41||0.004|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Pitfalls activity||||.004
91578369|NCT04893460|183044999|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.48||0.098|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Smoke Free activity||||.098
91578370|NCT04893460|183044999|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.68||0.042|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Letter to Youth activity||||.042
91578371|NCT04893460|183044999|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.22||0.364|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to 6 weeks post baseline.||||.364
91578372|NCT04893460|183045000|SUPERIORITY||median pairwise average|17.67|||<|0.001|TWO_SIDED||||||Wilcoxson Signed Rank Test|||The non-parametric Wilcoxon signed-rank test was used to evaluate whether participants were smoking fewer cigarettes per day.||||<.001
91578373|NCT04893460|183045001|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Cost activity|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED||||||t-test, 2 sided|||||||.776
91578374|NCT04893460|183045001|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Quit Latter activity|Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.45||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
91578375|NCT04893460|183045001|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Pitfalls activity|Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.55||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
91578376|NCT04893460|183045001|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Smoke Free activity|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.67||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
91578377|NCT04893460|183045001|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Letter to Youth activity|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|0.54||0.11|TWO_SIDED||||||t-test, 2 sided|||||||.110
91578378|NCT04893460|183045001|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to 6 week post baseline assessment|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.26||0.868|TWO_SIDED||||||t-test, 2 sided|||||||.868
91578379|NCT01325311|183045021|SUPERIORITY_OR_OTHER|||||||0.922|TWO_SIDED||||||t-test, 2 sided|||Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.||||0.922
91578380|NCT00215137|183045075|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.||||0.0002
91578381|NCT00215137|183045075|SUPERIORITY_OR_OTHER|||||||0.0417|TWO_SIDED|95.0|||||Wilcoxon Rank Sum Test|||A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.||||.0417
91578382|NCT03333876|183045076|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Each group was compared to baseline.||||<.001
91578383|NCT02055781|183045119|SUPERIORITY|||||||0.0011|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0011
91578384|NCT02055781|183045119|SUPERIORITY|||||||0.0173|||||||Fisher Exact|||||||0.0173
91578385|NCT02055781|183045119|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||||||0.0007
91578386|NCT02055781|183045120|SUPERIORITY|||||||0.0791|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0791
91578387|NCT02055781|183045120|SUPERIORITY|||||||0.6524|||||||Fisher Exact|||||||0.6524
91578388|NCT02055781|183045120|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
91578389|NCT00201643|183045130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.1162||0.002|TWO_SIDED|95.0|0.27|0.75||Analysis were also conducted in all randomized women with a known outcome \& in randomized treatment group(modified intent to treat). Analysis of the primary outcome used a repeated measures approach where each baby was considered a repeated measure|Fisher Exact|||Our Hypothesis was that administration of a rescue ACS would show a 40% reduction in incidence of composite neonatal morbity in patients delivering \< 34 weeks. Sample size estimates based on composite morbidity of 28%. Each arm required 217 subjects to have 80% power to detect a 40% reduction to 16.8%(2-tailed,alpha =0.05)using comparison for proportions/groups(Fisher exact test) OR,95% CI \& P values were determined using a repeated measure model where each twin is considered a repeat measure.||0.75|0.27|0.002
91578390|NCT00996476|183045194|SUPERIORITY_OR_OTHER||LS means difference|-2.4|||||TWO_SIDED|95.0|-2.83|-1.97|||ANCOVA||TMC435 50 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.97|-2.83|
91578391|NCT00996476|183045194|SUPERIORITY_OR_OTHER||LS Means difference|-2.41|||||TWO_SIDED|95.0|-2.85|-1.98|||ANCOVA||TMC435 100 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.98|-2.85|
91578392|NCT00996476|183045199|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-24.6|||||TWO_SIDED|95.0|-58.3|11.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group||11.8|-58.3|
91578393|NCT00996476|183045199|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-27.5|||||TWO_SIDED|95.0|-61.1|9.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group||9.8|-61.1|
91578394|NCT00996476|183045199|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-23.3|||||TWO_SIDED|95.0|-59.9|19.4|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group||19.4|-59.9|
91578395|NCT00996476|183045199|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-32.3|||||TWO_SIDED|95.0|-66.6|8.3|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group||8.3|-66.6|
91578396|NCT01470001|183045211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7||||0.1135|TWO_SIDED|95.0|-4.3|39.7|||Mixed Models Analysis|mixed model with repeated measurements||A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.||39.7|-4.3|.1135
91578397|NCT01470001|183045212|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.0919|TWO_SIDED|95.0|-2.3|30.8|||Regression, Logistic|logistic regression with repeated measurements||||30.8|-2.3|.0919
91578398|NCT01470001|183045213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.44|TWO_SIDED|95.0|-17.5|6.2||p value was adjusted for age.|ANCOVA||we calculated the estimated difference in change between the placebo and treatment groups.|the difference in change between the groups was measured||6.2|-17.5|0.44
91578399|NCT02387970|183045215|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
91578400|NCT02387970|183045216|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
91578401|NCT02387970|183045217|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||0.165
91578402|NCT02387970|183045218|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
91578403|NCT02387970|183045219|SUPERIORITY|||||||0.121|||||||t-test, 2 sided|||||||0.121
91578404|NCT02387970|183045220|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.248
91578405|NCT02387970|183045221|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
91578406|NCT02628028|183045223|SUPERIORITY|||||||0.473|||||||Regression, Logistic|||||||0.473
91578407|NCT02628028|183045223|SUPERIORITY|||||||0.67|||||||Regression, Logistic|||||||0.670
91578408|NCT02628028|183045223|SUPERIORITY|||||||0.823|||||||Regression, Logistic|||||||0.823
91578409|NCT02628028|183045224|SUPERIORITY|||||||0.743|||||||Regression, Logistic|||||||0.743
91578410|NCT02628028|183045224|SUPERIORITY|||||||0.124|||||||Regression, Logistic|||||||0.124
91578411|NCT02628028|183045224|SUPERIORITY|||||||0.858|||||||Regression, Logistic|||||||0.858
91578412|NCT02628028|183045225|SUPERIORITY|||||||0.199|||||||Regression, Logistic|||||||0.199
91578413|NCT02628028|183045225|SUPERIORITY|||||||0.028|||||||Regression, Logistic|||||||0.028
91578414|NCT02628028|183045225|SUPERIORITY|||||||0.863|||||||Regression, Logistic|||||||0.863
91578415|NCT02628028|183045226|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.863|TWO_SIDED|95.0|-0.53|0.44|||Mixed-effects Model for Repeated Measure|||||0.44|-0.53|0.863
91578416|NCT02628028|183045226|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.503|TWO_SIDED|95.0|-0.32|0.65|||Mixed-effects Model for Repeated Measure|||||0.65|-0.32|0.503
91578417|NCT02628028|183045226|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.289|TWO_SIDED|95.0|-0.77|0.23|||Mixed-effects Model for Repeated Measure|||||0.23|-0.77|0.289
91578418|NCT02628028|183045227|SUPERIORITY|||||||0.626|||||||Regression, Logistic|||||||0.626
91578419|NCT02628028|183045227|SUPERIORITY|||||||0.418|||||||Regression, Logistic|||||||0.418
91578420|NCT02628028|183045227|SUPERIORITY|||||||0.951|||||||Regression, Logistic|||||||0.951
91578421|NCT02628028|183045228|SUPERIORITY|||||||0.905|||||||Regression, Logistic|||||||0.905
91578422|NCT02628028|183045228|SUPERIORITY|||||||0.069|||||||Regression, Logistic|||||||0.069
91578423|NCT02628028|183045228|SUPERIORITY|||||||0.547|||||||Regression, Logistic|||||||0.547
91578424|NCT01743989|183045261|SUPERIORITY|||||||0.383|||||||Chi-squared|||||||0.383
91578425|NCT04655027|183045292|OTHER|Treatment effect|Difference in Estimate (LSM)|19.5|STANDARD_ERROR_OF_MEAN|15.62||0.212|TWO_SIDED|95.0|-11.155|50.15|||ANCOVA|||||50.150|-11.155|0.212
91578426|NCT04655027|183045293|OTHER|Baseline hepcidin by treatment effect|Difference in Estimate|-0.13|STANDARD_ERROR_OF_MEAN|0.17||0.441|TWO_SIDED|95.0|-0.477|0.208|||ANCOVA|||||0.208|-0.477|0.441
91578427|NCT04655027|183045293|OTHER|Baseline hs CRP by treatment effect|Difference in Estimates|-2.34|STANDARD_ERROR_OF_MEAN|3.76||0.532|TWO_SIDED|95.0|-9.707|5.017|||ANCOVA|||||5.017|-9.707|0.532
91578428|NCT04655027|183045294|OTHER|Treatment effect|Ratio of Estimates|1.09|STANDARD_ERROR_OF_MEAN|1.23||0.688|TWO_SIDED|95.0|0.723|1.635|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.635|0.723|0.688
91578429|NCT04655027|183045294|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.43|STANDARD_ERROR_OF_MEAN|0.2||0.029|TWO_SIDED|95.0|0.045|0.822|||ANCOVA|||||0.822|0.045|0.029
91578430|NCT04655027|183045294|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.568|TWO_SIDED|95.0|-0.201|0.366|||ANCOVA|||||0.366|-0.201|0.568
91578431|NCT04655027|183045295|OTHER|Treatment effect|Ratio of Estimates|0.84|STANDARD_ERROR_OF_MEAN|1.11||0.096|TWO_SIDED|95.0|0.687|1.031|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.031|0.687|0.096
91578432|NCT04655027|183045295|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.63|TWO_SIDED|95.0|-0.282|0.171|||ANCOVA|||||0.171|-0.282|0.630
91578433|NCT04655027|183045295|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|0.037|0.342|||ANCOVA|||||0.342|0.037|0.015
91578434|NCT04655027|183045296|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.123|1.354|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.354|1.123|< 0.001
91578435|NCT04655027|183045296|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.171|TWO_SIDED|95.0|-0.027|0.149|||ANCOVA|||||0.149|-0.027|0.171
91578436|NCT04655027|183045296|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.387|TWO_SIDED|95.0|-0.039|0.101|||ANCOVA|||||0.101|-0.039|0.387
91578437|NCT04655027|183045297|OTHER|Treatment effect|Ratio of Estimates|0.89|STANDARD_ERROR_OF_MEAN|1.22||0.561|TWO_SIDED|95.0|0.606|1.312|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.312|0.606|0.561
91578438|NCT04655027|183045297|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.043|TWO_SIDED|95.0|0.013|0.75|||ANCOVA|||||0.750|0.013|0.043
91578439|NCT04655027|183045297|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.766|TWO_SIDED|95.0|-0.222|0.302|||ANCOVA|||||0.302|-0.222|0.766
91578440|NCT04655027|183045298|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.108|1.369|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.369|1.108|< 0.001
91578441|NCT04655027|183045298|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.351|TWO_SIDED|95.0|-0.059|0.159|||ANCOVA|||||0.159|-0.059|0.351
91578442|NCT04655027|183045298|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.248|TWO_SIDED|95.0|-0.031|0.114|||ANCOVA|||||0.114|-0.031|0.248
91578443|NCT04655027|183045299|OTHER|Treatment effect|Ratio of Estimates|1.29|STANDARD_ERROR_OF_MEAN|1.11||0.021|TWO_SIDED|95.0|1.043|1.598|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.598|1.043|0.021
91578444|NCT04655027|183045299|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.826|TWO_SIDED|95.0|-0.276|0.223|||ANCOVA|||||0.223|-0.276|0.826
91578445|NCT04655027|183045299|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.634|TWO_SIDED|95.0|-0.212|0.132|||ANCOVA|||||0.132|-0.212|0.634
91578446|NCT04655027|183045300|OTHER|Treatment effect|Ratio of Estimates|0.45|STANDARD_ERROR_OF_MEAN|1.31||0.007|TWO_SIDED|95.0|0.257|0.786|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||0.786|0.257|0.007
91578447|NCT04655027|183045300|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.798|0.48|||ANCOVA|||||0.480|-0.798|0.610
91578448|NCT04655027|183045300|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.74|TWO_SIDED|95.0|-0.387|0.536|||ANCOVA|||||0.536|-0.387|0.740
91578449|NCT00186888|183045333|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|88.9|||||TWO_SIDED|95.0|71.3|96.9||||||||96.9|71.3|
91578450|NCT00186888|183045334|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|91.7|||||TWO_SIDED|95.0|65.1|99.6||||||||99.6|65.1|
91578451|NCT00186888|183045335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.452||95.0|||||ANOVA|||CYP3A4\*1B: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.452
91578452|NCT00186888|183045335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0|||||ANOVA|||CYP3A5\*3: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.106
91578453|NCT00186888|183045336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0|||||ANOVA|||BCRP 1143: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.245
91578454|NCT00186888|183045336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||ANOVA|||BCRP 15622: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.297
91578455|NCT00186888|183045336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0|||||ANOVA|||BCRP Exon 2: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.372
91578456|NCT00186888|183045336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANOVA|||BCRP Exon 5: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.844
91578457|NCT00186888|183045336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.616||95.0|||||ANOVA|||Pgp Exon 21: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.616
91578458|NCT00186888|183045336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.424||95.0|||||ANOVA|||Pgp Exon 26: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.424
91578459|NCT04777864|183045377|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Parent group only||||0.18
91578460|NCT04777864|183045377|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Adolescent group only||||0.91
91578461|NCT04777864|183045378|SUPERIORITY|||||||0.975|||||||Regression, Linear|||Parent: Post-Index Visit||||0.975
91578462|NCT04777864|183045378|SUPERIORITY|||||||0.854|||||||Regression, Linear|||Adolescent: Post-Index Visit||||0.854
91578463|NCT04777864|183045381|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Post-Index Visit||||0.03
91578464|NCT04777864|183045381|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.21
91578465|NCT04777864|183045382|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Baseline||||0.76
91578466|NCT04777864|183045382|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Post-Index Visit||||0.96
91578467|NCT04777864|183045382|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.96
91578468|NCT03086655|183045383|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.93|||||This is the 'inflation part' of the zero inflated negative binomial model. We used cluster robust standard errors due to the multiple observations over time being nested within participant. Result shows odds of intervention group relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing a large number of 0. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 1: the odds of having 0 openings is lower in intervention than control group."||1.93|0.90|
91578469|NCT03086655|183045383|SUPERIORITY||incidence rate ratio (IRR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||||This is the negative binomial part of the model. We used cluster robust standard errors due to the multiple observations being nested within participant. Result shows intervention group had lower rate of openings relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing many 0s. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 2: the incidence rate ratio for # days with box opening is \>1, i.e. more openings in intervention than control group."||0.98|0.61|
91578470|NCT03086655|183045384|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (2 d.f.), simultaneously testing if parameters for both 6 mo. by intervention and 12 mo. by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of undetectable VL as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of undetectable VL will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
91578471|NCT03086655|183045385|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|-0.11|0.43||a priori threshold for statistical significance was p=0.05.|t-test, 2 sided|(equal variances assumed)|Difference = control group - treatment group|||0.43|-0.11|<0.05
91578472|NCT03086655|183045386|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (4 d.f.), simultaneously testing if parameters for all follow-ups by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of optimal adherence as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of optimal adherence will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
91578473|NCT04531982|183045392|SUPERIORITY|||||||0.4825||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||Difference between LSM changes for adjunctive pimavanserin and adjunctive placebo (pimavanserin - placebo) at the specified visit from MMRM analysis.||||0.4825
91578474|NCT04531982|183045393|SUPERIORITY|||||||0.8872||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||||||0.8872
91578475|NCT03524092|183045394|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|15.2|31.2|||Cochran-Mantel-Haenszel|||||31.2|15.2|<0.001
91578476|NCT03524092|183045395|SUPERIORITY||Risk Difference (RD)|28.5|||<|0.001|TWO_SIDED|95.0|20.2|36.8|||Cochran-Mantel-Haenszel|||||36.8|20.2|<0.001
91578477|NCT03524092|183045396|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|14.5|<0.001
91578478|NCT03524092|183045397|SUPERIORITY||Risk Difference (RD)|30.2|||<|0.001|TWO_SIDED|95.0|21.9|38.6|||Cochran-Mantel-Haenszel|||||38.6|21.9|<0.001
91578479|NCT03524092|183045398|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.4|39.6|||Cochran-Mantel-Haenszel|||||39.6|22.4|<0.001
91578480|NCT03524092|183045399|SUPERIORITY||Risk Difference (RD)|30.6|||<|0.001|TWO_SIDED|95.0|22.3|38.9|||Cochran-Mantel-Haenszel|||||38.9|22.3|<0.001
91578481|NCT03524092|183045400|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|3.094|<|0.001|TWO_SIDED|95.0|19.16|31.32|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||31.32|19.16|<0.001
91578482|NCT03524092|183045401|SUPERIORITY||LS Mean difference (Final Values)|-839.64|STANDARD_ERROR_OF_MEAN|245.99|<|0.001|TWO_SIDED|95.0|-1323.08|-356.21|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||-356.21|-1323.08|<0.001
91578483|NCT03524092|183045402|SUPERIORITY||LS Mean difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.228|<|0.001|TWO_SIDED|95.0|-1.51|-0.61|||Mixed Models Analysis|||||-0.61|-1.51|<0.001
91578484|NCT04303780|183045405|EQUIVALENCE|A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.|Hazard Ratio (HR)|0.663||||0.002|TWO_SIDED|95.0|0.509|0.864|||Log Rank|||||0.864|0.509|0.002
91578485|NCT03826030|183045406|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||The null hypothesis was no overall difference in FM-UE scale change between the three groups on day 15. The change in FM-UE was modelled using a linear mixed-effects repeated measures model adjusted for visit (ie, day 15, day 45, and day 105), treatment group, treatment group by visit interaction, baseline FM-UE, time from stroke (30-90 vs. 91-180 days), and enrolment site. An AR(1) autocorrelation structure was used for visit, and variance components structure for sites.||||0.39
91578486|NCT01732822|183045413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.65|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.650
91578487|NCT01732822|183045414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.738|TWO_SIDED|95.0|0.92|1.12||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.12|0.92|0.738
91578488|NCT01732822|183045415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.4|TWO_SIDED|95.0|0.92|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.92|0.400
91578489|NCT01732822|183045416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.482|TWO_SIDED|95.0|0.91|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.91|0.482
91578490|NCT01732822|183045417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.913|TWO_SIDED|95.0|0.89|1.11||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.11|0.89|0.913
91578491|NCT01732822|183045418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.724|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.724
91578492|NCT01732822|183045419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.846|TWO_SIDED|95.0|0.79|1.33||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.33|0.79|0.846
91578493|NCT01732822|183045420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.298|TWO_SIDED|95.0|0.87|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.87|0.298
91578494|NCT01732822|183045421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.462|TWO_SIDED|95.0|0.9|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.90|0.462
91578495|NCT01732822|183045422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.793|TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|||||1.12|0.92|0.793
91578496|NCT01732822|183045423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.92|1.09|||Regression, Cox|||||1.09|0.92|1.000
91578497|NCT01732822|183045424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.829|TWO_SIDED|95.0|0.91|1.08|||Regression, Cox|||||1.08|0.91|0.829
91578498|NCT01732822|183045425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.949|TWO_SIDED|95.0|0.92|1.08|||Regression, Cox|||||1.08|0.92|0.949
91578499|NCT01732822|183045426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.377|TWO_SIDED|95.0|0.78|1.1|||Regression, Cox|||||1.10|0.78|0.377
91578500|NCT01732822|183045430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.164
91578501|NCT01732822|183045431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.306|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|||||1.14|0.67|0.306
91578502|NCT01732822|183045432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.887|TWO_SIDED|95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.887
91578503|NCT01732822|183045433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.489|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||||1.43|0.84|0.489
91578504|NCT01732822|183045434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.138|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox|||||1.43|0.95|0.138
91578505|NCT01732822|183045435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.139|TWO_SIDED|95.0|0.95|1.41|||Regression, Cox|||||1.41|0.95|0.139
91578506|NCT01732822|183045436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.24|2.0|||Regression, Cox|||||2.00|1.24|<0.001
91578507|NCT02314780|183045437|OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
91578508|NCT02314780|183045438|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
91578509|NCT02314780|183045439|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
91578510|NCT02314780|183045440|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91578511|NCT02314780|183045441|OTHER||||||=|0.138|||||||ANOVA|||||||=0.138
91578512|NCT02314780|183045442|OTHER||||||=|0.696|||||||ANOVA|||||||=0.696
91578513|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|77.4||||||95.0||||||||||||
91578514|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|28.4||||||95.0||||||||||||
91578515|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.7||||||95.0||||||||||||
91578516|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|4.9||||||95.0||||||||||||
91578517|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|79.2||||||95.0||||||||||||
91578518|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.1||||||95.0||||||||||||
91578519|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|3.8||||||95.0||||||||||||
91578520|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|6.1||||||95.0||||||||||||
91578521|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|82.4||||||95.0||||||||||||
91578522|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.5||||||95.0||||||||||||
91578523|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.9||||||95.0||||||||||||
91578524|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|5.8||||||95.0||||||||||||
91578525|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|76.9||||||95.0||||||||||||
91578526|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|20.0||||||95.0||||||||||||
91578527|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|6.2||||||95.0||||||||||||
91578528|NCT00379288|183045443|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|3.1||||||95.0||||||||||||
91578529|NCT00833833|183045488|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73|||||TWO_SIDED|95.0|0.54|0.99||||||With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.||0.99|0.54|
91578530|NCT00833833|183045493|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|6.25|||||TWO_SIDED|95.0|0.84|46.66||||||||46.66|0.84|
91578531|NCT00833833|183045494|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.070
91578532|NCT00833833|183045495|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.57|1.29||||||||1.29|0.57|
91578533|NCT00921687|183045515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.04|TWO_SIDED|95.0|1.01|2.3|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||2.30|1.01|0.04
91578534|NCT00921687|183045516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.44||95.0|0.84|1.49|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||1.49|0.84|0.44
91578535|NCT00316602|183045517|NON_INFERIORITY|The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.|Difference in seroconversion rates (%)|-1.2|||||ONE_SIDED|97.5|-4.3||||||||||-4.3|
91578536|NCT00626990|183045532|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.76|TWO_SIDED|99.1|0.73|1.28|||Regression, Cox|||||1.28|0.73|0.76
91578537|NCT00626990|183045532|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Regression, Cox|||||0.79|0.52|<0.0001
91578538|NCT00626990|183045533|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.11|TWO_SIDED|95.0|0.72|1.03|||Regression, Cox|||||1.03|0.72|0.11
91578539|NCT00626990|183045533|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.7|||Regression, Cox|||||0.70|0.49|<0.0001
91578540|NCT03446781|183045538|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.002
91578541|NCT03446781|183045539|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578542|NCT03446781|183045540|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578543|NCT03446781|183045541|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578544|NCT03446781|183045542|SUPERIORITY|||||||0.033|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.033
91578545|NCT03446781|183045543|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578546|NCT03446781|183045544|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578547|NCT03446781|183045545|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578548|NCT03446781|183045546|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
91578549|NCT02898077|183045552|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.0184|TWO_SIDED|95.0|0.613|0.955|||Log Rank|||||0.955|0.613|0.0184
91578550|NCT02898077|183045553|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.771|1.203||||||||1.203|0.771|
91578551|NCT02898077|183045554|SUPERIORITY||Hazard Ratio (HR)|0.761|||||TWO_SIDED|95.0|0.598|0.968||||||||0.968|0.598|
91578552|NCT02898077|183045555|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
91578553|NCT02898077|183045556|SUPERIORITY||Hazard Ratio (HR)|0.905|||||TWO_SIDED|95.0|0.577|1.421||||||||1.421|0.577|
91578554|NCT03268603|183045572|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
91578555|NCT03248882|183045633|SUPERIORITY||Mean Difference (Net)|-10.7|||||TWO_SIDED|80.0|-19.4|-1.1||||||||-1.1|-19.4|
91578556|NCT03248882|183045633|SUPERIORITY||Mean Difference (Net)|-46.0|||||TWO_SIDED|80.0|-51.3|-40.1||||||||-40.1|-51.3|
91578557|NCT03248882|183045633|SUPERIORITY||Mean Difference (Net)|-52.4|||||TWO_SIDED|80.0|-57.2|-47.1||||||||-47.1|-57.2|
91578558|NCT03248882|183045633|SUPERIORITY||Mean Difference (Net)|-62.1|||||TWO_SIDED|80.0|-66.0|-57.8||||||||-57.8|-66.0|
91578559|NCT03248882|183045634|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|80.0|-14.0|6.3||||||||6.3|-14.0|
91578560|NCT03248882|183045634|SUPERIORITY||Mean Difference (Net)|-21.0|||||TWO_SIDED|80.0|-29.0|-12.2||||||||-12.2|-29.0|
91578561|NCT03248882|183045634|SUPERIORITY||Mean Difference (Net)|-25.0|||||TWO_SIDED|80.0|-32.8|-16.1||||||||-16.1|-32.8|
91578562|NCT03248882|183045634|SUPERIORITY||Mean Difference (Net)|-41.8|||||TWO_SIDED|80.0|-47.9|-35.0||||||||-35.0|-47.9|
91578563|NCT02236988|183045647|OTHER||Ratio of Adjusted Geometric Means|65.3|||||TWO_SIDED|90.0|55.0|77.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an analysis of variance (ANOVA) was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||77.6|55.0|
91578564|NCT02236988|183045647|OTHER||Ratio of Adjusted Geometric Means|80.4|||||TWO_SIDED|90.0|67.8|95.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||95.5|67.8|
91578565|NCT02236988|183045647|OTHER||Ratio of Adjusted Geometric Means|84.2|||||TWO_SIDED|90.0|70.9|99.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||99.9|70.9|
91578566|NCT02236988|183045649|OTHER||Ratio of Adjusted Geometric Means|61.8|||||TWO_SIDED|90.0|51.7|73.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||73.9|51.7|
91578567|NCT02236988|183045649|OTHER||Ratio of Adjusted Geometric Means|71.2|||||TWO_SIDED|90.0|59.6|85.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.1|59.6|
91578568|NCT02236988|183045649|OTHER||Ratio of Adjusted Geometric Means|73.8|||||TWO_SIDED|90.0|61.7|88.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.2|61.7|
91578569|NCT02236988|183045650|OTHER||Ratio of Adjusted Geometric Means|62.3|||||TWO_SIDED|90.0|52.1|74.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.4|52.1|
91578570|NCT02236988|183045650|OTHER||Ratio of Adjusted Geometric Means|71.3|||||TWO_SIDED|90.0|59.7|85.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.2|59.7|
91578571|NCT02236988|183045650|OTHER||Ratio of Adjusted Geometric Means|74.0|||||TWO_SIDED|90.0|62.0|88.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.4|62.0|
91578572|NCT02236988|183045651|OTHER||Median Difference|1.0||||0.009|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 1 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.5|0.0090
91578573|NCT02236988|183045651|OTHER||Median Difference|1.26||||0.0073|TWO_SIDED|90.0|0.5|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 2 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|0.50|0.0073
91578574|NCT02236988|183045651|OTHER||Median Difference|2.0|||<|0.0001|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 3 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|<0.0001
91578575|NCT02236988|183045657|OTHER||Ratio of Adjusted Geometric Means|90.9|||||TWO_SIDED|90.0|81.8|101.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||101.1|81.8|
91578576|NCT02236988|183045657|OTHER||Ratio of Adjusted Geometric Means|73.7|||||TWO_SIDED|90.0|66.3|82.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||82.0|66.3|
91578577|NCT02236988|183045657|OTHER||Ratio of Adjusted Geometric Means|80.2|||||TWO_SIDED|90.0|72.2|89.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.2|72.2|
91578578|NCT02236988|183045658|OTHER||Ratio of Adjusted Geometric Means|84.9|||||TWO_SIDED|90.0|77.5|93.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.0|77.5|
91578579|NCT02236988|183045658|OTHER||Ratio of Adjusted Geometric Means|72.0|||||TWO_SIDED|90.0|65.8|78.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||78.9|65.8|
91578580|NCT02236988|183045658|OTHER||Ratio of Adjusted Geometric Means|78.0|||||TWO_SIDED|90.0|71.2|85.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.5|71.2|
91578581|NCT02236988|183045659|OTHER||Ratio of Adjusted Geometric Means|85.5|||||TWO_SIDED|90.0|78.1|93.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.6|78.1|
91578582|NCT02236988|183045659|OTHER||Ratio of Adjusted Geometric Means|72.6|||||TWO_SIDED|90.0|66.3|79.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||79.5|66.3|
91578583|NCT02236988|183045659|OTHER||Ratio of Adjusted Geometric Means|78.9|||||TWO_SIDED|90.0|72.0|86.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.4|72.0|
91578584|NCT02236988|183045660|OTHER||Median Difference|2.0||||0.0002|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 4 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0002
91578585|NCT02236988|183045660|OTHER||Median Difference|1.02||||0.0049|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 5 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.50|0.0049
91578586|NCT02236988|183045660|OTHER||Median Difference|1.5||||0.001|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 6 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|1.00|0.0010
91578587|NCT02236988|183045666|OTHER||Ratio of Adjusted Geometric Means|91.0|||||TWO_SIDED|90.0|80.4|103.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||103.0|80.4|
91578588|NCT02236988|183045666|OTHER||Ratio of Adjusted Geometric Means|88.4|||||TWO_SIDED|90.0|78.1|100.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||100.0|78.1|
91578589|NCT02236988|183045667|OTHER||Ratio of Adjusted Geometric Means|80.6|||||TWO_SIDED|90.0|73.8|88.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.0|73.8|
91578590|NCT02236988|183045667|OTHER||Ratio of Adjusted Geometric Means|78.5|||||TWO_SIDED|90.0|71.9|85.7|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.7|71.9|
91578591|NCT02236988|183045668|OTHER||Ratio of Adjusted Geometric Means|81.1|||||TWO_SIDED|90.0|74.3|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|74.3|
91578592|NCT02236988|183045668|OTHER||Ratio of Adjusted Geometric Means|79.0|||||TWO_SIDED|90.0|72.3|86.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.3|72.3|
91578593|NCT02236988|183045669|OTHER||Median Difference|0.98||||0.0374|TWO_SIDED|90.0|0.02|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 8 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.02|0.0374
91578594|NCT02236988|183045669|OTHER||Median Difference|0.51||||0.1907|TWO_SIDED|90.0|0.0|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 9 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.00|0.1907
91578595|NCT02236988|183045675|OTHER||Ratio of Adjusted Geometric Means|109.4|||||TWO_SIDED|90.0|98.6|121.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||121.3|98.6|
91578596|NCT02236988|183045675|OTHER||Ratio of Adjusted Geometric Means|107.2|||||TWO_SIDED|90.0|96.4|119.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||119.2|96.4|
91578597|NCT02236988|183045675|OTHER||Ratio of Adjusted Geometric Means|72.7|||||TWO_SIDED|90.0|65.5|80.8|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||80.8|65.5|
91578598|NCT02236988|183045675|OTHER||Ratio of Adjusted Geometric Means|103.5|||||TWO_SIDED|90.0|93.1|114.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||114.9|93.1|
91578599|NCT02236988|183045676|OTHER||Ratio of Adjusted Geometric Means|81.5|||||TWO_SIDED|90.0|75.2|88.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.3|75.2|
91578600|NCT02236988|183045676|OTHER||Ratio of Adjusted Geometric Means|82.4|||||TWO_SIDED|90.0|75.9|89.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.5|75.9|
91578601|NCT02236988|183045676|OTHER||Ratio of Adjusted Geometric Means|68.2|||||TWO_SIDED|90.0|62.9|74.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.0|62.9|
91578602|NCT02236988|183045676|OTHER||Ratio of Adjusted Geometric Means|77.4|||||TWO_SIDED|90.0|71.3|84.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.0|71.3|
91578603|NCT02236988|183045677|OTHER||Ratio of Adjusted Geometric Means|81.9|||||TWO_SIDED|90.0|75.6|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|75.6|
91578604|NCT02236988|183045677|OTHER||Ratio of Adjusted Geometric Means|83.0|||||TWO_SIDED|90.0|76.5|90.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||90.1|76.5|
91578605|NCT02236988|183045677|OTHER||Ratio of Adjusted Geometric Means|68.8|||||TWO_SIDED|90.0|63.4|74.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.5|63.4|
91578606|NCT02236988|183045677|OTHER||Ratio of Adjusted Geometric Means|77.8|||||TWO_SIDED|90.0|71.8|84.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.4|71.8|
91578607|NCT02236988|183045678|OTHER||Median Difference|0.98||||0.0523|TWO_SIDED|90.0|0.03|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 11 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.03|0.0523
91578608|NCT02236988|183045678|OTHER||Median Difference|0.5||||0.2598|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 12 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.2598
91578609|NCT02236988|183045678|OTHER||Median Difference|1.5||||0.0053|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 13 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0053
91578610|NCT02236988|183045678|OTHER||Median Difference|0.5||||0.1093|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 14 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.1093
91578611|NCT04308590|183045687|EQUIVALENCE|The primary analysis will determine whether there is a difference between treatment groups in terms of change from Baseline to Week 22 in 24-hour average SBP. This was performed using a linear mixed-model-for-repeated-measures (MMRM) analysis using a placebo wash-out multiple imputation for treatment discontinuation and for patients that use rescue medication.|Least squares mean difference|-2.67||||0.416|TWO_SIDED|95.0|-9.096|3.766|||Mixed Models Analysis|||||3.766|-9.096|0.4160
91578612|NCT01072630|183045796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1302|TWO_SIDED|95.0|-4.67|0.6||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.60|-4.67|0.1302
91578613|NCT01072630|183045796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.135|TWO_SIDED|95.0|-4.51|0.61||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.61|-4.51|0.1350
91578614|NCT05032872|183045819|SUPERIORITY|||||||0.49||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time by condition interaction||||.49
91578615|NCT05032872|183045820|SUPERIORITY|||||||0.48||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.48
91578616|NCT05032872|183045821|SUPERIORITY|||||||0.04||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quality||||.04
91578617|NCT05032872|183045821|SUPERIORITY|||||||0.44||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting dissatisfaction with contact quantity||||.44
91578618|NCT05032872|183045821|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quantity||||.99
91578619|NCT05032872|183045821|SUPERIORITY|||||||0.87||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting knowing others' experience||||.87
91578620|NCT05032872|183045821|SUPERIORITY|||||||0.98||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting shared understanding||||.98
91578621|NCT05032872|183045821|SUPERIORITY|||||||0.76||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relationship salience||||.76
91578622|NCT05032872|183045822|SUPERIORITY|||||||0.29||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.29
91578623|NCT05032872|183045823|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting positive affect||||.51
91578624|NCT05032872|183045823|SUPERIORITY|||||||0.83||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting negative affect||||.83
91578625|NCT05032872|183045824|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.51
91578626|NCT05032872|183045825|SUPERIORITY|||||||0.65||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.65
91578627|NCT05032872|183045826|SUPERIORITY|||||||0.01||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of distress||||.01
91578628|NCT05032872|183045826|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||time x condition interaction predicting caregiver overload||||.75
91578629|NCT05032872|183045826|SUPERIORITY|||||||0.59||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relational deprivation||||.59
91578630|NCT05032872|183045826|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting job caregiving conflict||||.51
91578631|NCT05032872|183045826|SUPERIORITY|||||||0.25||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting role captivity||||.25
91578632|NCT05032872|183045826|SUPERIORITY|||||||0.34||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting sense of self||||.34
91578633|NCT05032872|183045826|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting personal gain||||.75
91578634|NCT05032872|183045826|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting caregiving competence||||.99
91578635|NCT05032872|183045826|SUPERIORITY|||||||0.61||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of situition||||.61
91578636|NCT05032872|183045826|SUPERIORITY|||||||0.92||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of meaning||||.92
91578637|NCT05032872|183045826|SUPERIORITY|||||||0.96||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting expressive support||||.96
91578638|NCT05032872|183045827|SUPERIORITY|||||||0.37||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.37
91578639|NCT05032872|183045828|SUPERIORITY|||||||0.89||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.89
91578640|NCT05032872|183045829|SUPERIORITY|||||||0.3||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.30
91578641|NCT05032872|183045830|SUPERIORITY|||||||0.52||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.52
91578642|NCT05032872|183045831|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Independent sample T-test comparing the treatment and control group||||.45
91578643|NCT00338962|183045833|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.|Mixed Models Analysis|F=49.633||||||0.00
91578644|NCT00338962|183045835|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANOVA|||Gastrointestinal symptoms compared||||0.007
91578645|NCT03733314|183045836|SUPERIORITY||Difference|10.3|||||TWO_SIDED|95.0|-24.9|45.4|||||The difference of percentage was calculated as E6011 minus placebo.|||45.4|-24.9|
91578646|NCT03733314|183045841|SUPERIORITY||Difference|-7.1|||||TWO_SIDED|95.0|-32.1|18.0|||||The difference of percentage was calculated as E6011 minus placebo.|||18.0|-32.1|
91578647|NCT03733314|183045842|SUPERIORITY||Difference|8.3|||||TWO_SIDED|95.0|-7.3|24.0|||||The difference of percentage was calculated as E6011 minus placebo.|||24.0|-7.3|
91578648|NCT04155047|183045871|SUPERIORITY||Least Squares Mean Difference|-0.323|STANDARD_ERROR_OF_MEAN|0.1861||0.0987|TWO_SIDED|95.0|-0.711|0.066|||Mixed Models Analysis|||||0.066|-0.711|0.0987
91578649|NCT04514510|183045872|SUPERIORITY|||||||0.64|||||||ANCOVA with Multiple Imputation|||||||0.64
91578650|NCT04514510|183045878|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
91578651|NCT00821587|183045882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||We hypothesize that subjects on CsA are more likely to achieve undetectable viral level in patients receiving antiviral therapy for recurrent HCV after Liver Transplant|Chi-squared|||We hypothesize that subjects on CsA are more likely to achieve undetectable viral levels after liver transplant. Comparisons between the two groups (Undetectable viral level vs. Detectable viral level) were performed with Pearson Chi-square tests or Fisher's exact test for categorical variables, and Mann-Whitney U test for continuous variables.||||<0.05
91578652|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|7.11|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578653|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|5.98|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578654|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|7.17||||0.0006|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0006
91578655|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|4.75|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578656|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|5.95||||0.0002|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0002
91578657|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 500 lux is reported."|Slope|6.92||||0.0285|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0285
91578658|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 500 lux is reported."|Slope|6.99|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578659|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|6.8|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578660|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|5.94||||0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0001
91578661|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|5.85||||0.012|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.012
91578662|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NYmass at 500 lux is reported."|Slope|-9.62||||0.0174|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0174
91578663|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 500 lux is reported."|Slope|-9.15||||0.013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.013
91578664|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-4.06|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578665|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|0.99||||0.0068|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0068
91578666|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|1.12||||0.0485|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0485
91578667|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|2.08||||0.0031|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0031
91578668|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|1.18||||0.0036|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0036
91578669|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|1.05||||0.0089|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0089
91578670|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-4.04|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578671|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|1.62||||0.0239|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0239
91578672|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|0.93||||0.0435|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0435
91578673|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 500 lux is reported."|Slope|1.26||||0.0126|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0126
91578674|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-0.73||||0.0294|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0294
91578675|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 50 lux is reported."|Slope|0.96||||0.0204|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0204
91578676|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 50 lux is reported."|Slope|1.41||||0.0004|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0004
91578677|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-0.95||||0.0013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0013
91578678|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-0.77||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
91578679|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-0.94|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578680|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 50 lux is reported."|Slope|0.81|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578681|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-0.87||||0.0096|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0096
91578682|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 500 lux is reported."|Slope|0.36||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
91578683|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 50 lux is reported."|Slope|2.13||||0.0063|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0063
91578684|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 50 lux is reported."|Slope|2.3||||0.0018|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0018
91578685|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Pa at 50 lux is reported."|Slope|3.22||||0.0134|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0134
91578686|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|-1.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578687|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-2.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578688|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|-1.264|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578689|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|-1.47|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578690|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-1.64|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578691|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-1.63|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578692|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for PESC at 50 lux is reported."|Slope|1.43||||0.0313|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0313
91578693|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM5 at 500 lux is reported."|Slope|1.92||||0.0481|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0481
91578694|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 500 lux is reported."|Slope|2.57||||0.0171|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0171
91578695|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|3.84||||0.0007|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0007
91578696|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for dbase at 500 lux is reported."|Slope|-2.15|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578697|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 500 lux is reported."|Slope|-2.2|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578698|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|-2.44|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578699|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|-3.01|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578700|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|-1.82|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578701|NCT05731999|183045904|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 500 lux is reported."|Slope|-1.83|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
91578702|NCT05731999|183045906|OTHER||probability|0.000244|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The smallest odds ratio from the group false positives and false negative is reported.||||<0.05
91578703|NCT05731999|183045906|OTHER||probability|0.00586|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
91578704|NCT05731999|183045906|OTHER||probability|0.0193|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
91578705|NCT05731999|183045906|OTHER||probability|0.000488|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
91578706|NCT05731999|183045906|OTHER||probability|0.1133|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
91578707|NCT05731999|183045906|OTHER||probability|0.0107|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
91578708|NCT02551653|183045940|OTHER||Mean Ratio|0.832|||||TWO_SIDED|95.0|0.682|0.979|||||||Volume of Distribution - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|0.979|0.682|
91578709|NCT02551653|183045940|OTHER||Mean Ratio|1.472|||||TWO_SIDED|95.0|1.113|1.891|||||||Volume of Distribution - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.891|1.113|
91578710|NCT02551653|183045940|OTHER||Mean Ratio|0.958|||||TWO_SIDED|95.0|0.692|1.241|||||||Volume of Distribution - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.241|0.692|
91578711|NCT02551653|183045941|OTHER||Mean Ratio|1.013|||||TWO_SIDED|95.0|0.846|1.189|||||||Mean Standardized Uptake Values - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.189|0.846|
91578712|NCT02551653|183045941|OTHER||Mean Ratio|1.056|||||TWO_SIDED|95.0|0.853|1.269|||||||Mean Standardized Uptake Values - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.269|0.853|
91578713|NCT02551653|183045941|OTHER||Mean Ratio|1.047|||||TWO_SIDED|95.0|0.786|1.34|||||||Mean Standardized Uptake Values - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.340|0.786|
91578714|NCT02683785|183045942|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value,Treatment Group,Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used.p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented.|||0.58|-1.31|0.442
91578715|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.46||||0.046|TWO_SIDED|95.0|-0.9|-0.01||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||-0.01|-0.90|0.046
91578716|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.38||||0.257|TWO_SIDED|95.0|-1.05|0.29||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.29|-1.05|0.257
91578717|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.5||||0.22|TWO_SIDED|95.0|-1.31|0.31||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.31|-1.31|0.220
91578718|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.74||||0.085|TWO_SIDED|95.0|-1.59|0.11||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.11|-1.59|0.085
91578719|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.58|-1.31|0.442
91578720|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.83||||0.139|TWO_SIDED|95.0|-1.93|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.28|-1.93|0.139
91578721|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.9||||0.103|TWO_SIDED|95.0|-2.0|0.19||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||0.19|-2.00|0.103
91578722|NCT02683785|183045943|OTHER||Mean Difference (Net)|-0.89||||0.132|TWO_SIDED|95.0|-2.06|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.28|-2.06|0.132
91578723|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.45||||0.082|TWO_SIDED|95.0|-0.97|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented.|||0.06|-0.97|0.082
91578724|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.27||||0.426|TWO_SIDED|95.0|-0.96|0.41||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.41|-0.96|0.426
91578725|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.6||||0.129|TWO_SIDED|95.0|-1.38|0.18||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.18|-1.38|0.129
91578726|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.78||||0.067|TWO_SIDED|95.0|-1.63|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented.|||0.06|-1.63|0.067
91578727|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.33||||0.494|TWO_SIDED|95.0|-1.28|0.63||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.63|-1.28|0.494
91578728|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.94||||0.107|TWO_SIDED|95.0|-2.08|0.21||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented.|||0.21|-2.08|0.107
91578729|NCT02683785|183045944|OTHER||Mean Difference (Net)|-0.98||||0.092|TWO_SIDED|95.0|-2.13|0.17||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented.|||0.17|-2.13|0.092
91578730|NCT02683785|183045944|OTHER||Mean Difference (Net)|-1.01||||0.098|TWO_SIDED|95.0|-2.22|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.20|-2.22|0.098
91578731|NCT02683785|183045949|OTHER||Mean Difference (Net)|-2.8||||0.061|TWO_SIDED|95.0|-5.6|0.1||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 1|||0.1|-5.6|0.061
91578732|NCT02683785|183045949|OTHER||Mean Difference (Net)|-2.0||||0.282|TWO_SIDED|95.0|-5.6|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Pain component, Week 2|||1.7|-5.6|0.282
91578733|NCT02683785|183045949|OTHER||Mean Difference (Net)|-3.7||||0.113|TWO_SIDED|95.0|-8.4|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component Week 4|||0.9|-8.4|0.113
91578734|NCT02683785|183045949|OTHER||Mean Difference (Net)|-1.0||||0.695|TWO_SIDED|95.0|-5.9|4.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 6|||4.0|-5.9|0.695
91578735|NCT02683785|183045949|OTHER||Mean Difference (Net)|-3.8||||0.176|TWO_SIDED|95.0|-9.4|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 8|||1.8|-9.4|0.176
91578736|NCT02683785|183045949|OTHER||Mean Difference (Net)|-5.5||||0.041|TWO_SIDED|95.0|-10.8|-0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 10|||-0.2|-10.8|0.041
91578737|NCT02683785|183045949|OTHER||Mean Difference (Net)|-4.7||||0.082|TWO_SIDED|95.0|-10.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 12|||0.6|-10.1|0.082
91578738|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.2||||0.587|TWO_SIDED|95.0|-1.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 1|||0.6|-1.1|0.587
91578739|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.4||||0.457|TWO_SIDED|95.0|-1.3|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 2|||0.6|-1.3|0.457
91578740|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.6||||0.298|TWO_SIDED|95.0|-1.8|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 4|||0.6|-1.8|0.298
91578741|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.2||||0.726|TWO_SIDED|95.0|-1.3|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 6|||0.9|-1.3|0.726
91578742|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.7||||0.213|TWO_SIDED|95.0|-1.9|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 8|||0.4|-1.9|0.213
91578743|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.6||||0.331|TWO_SIDED|95.0|-1.9|0.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 10|||0.7|-1.9|0.331
91578744|NCT02683785|183045949|OTHER||Mean Difference (Net)|-0.8||||0.248|TWO_SIDED|95.0|-2.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 12|||0.6|-2.1|0.248
91578745|NCT02683785|183045949|OTHER||Mean Difference (Net)|-2.9||||0.35|TWO_SIDED|95.0|-9.0|3.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 1|||3.3|-9.0|0.350
91578746|NCT02683785|183045949|OTHER||Mean Difference (Net)|-3.0||||0.383|TWO_SIDED|95.0|-9.8|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 2|||3.8|-9.8|0.383
91578747|NCT02683785|183045949|OTHER||Mean Difference (Net)|-4.8||||0.271|TWO_SIDED|95.0|-13.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 4|||3.9|-13.5|0.271
91578748|NCT02683785|183045949|OTHER||Mean Difference (Net)|-2.7||||0.565|TWO_SIDED|95.0|-12.1|6.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 6|||6.7|-12.1|0.565
91578749|NCT02683785|183045949|OTHER||Mean Difference (Net)|-4.9||||0.343|TWO_SIDED|95.0|-15.2|5.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 8|||5.4|-15.2|0.343
91578750|NCT02683785|183045949|OTHER||Mean Difference (Net)|-6.2||||0.266|TWO_SIDED|95.0|-17.3|4.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 10|||4.9|-17.3|0.266
91578751|NCT02683785|183045949|OTHER||Mean Difference (Net)|-8.2||||0.136|TWO_SIDED|95.0|-19.1|2.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 12|||2.7|-19.1|0.136
91578752|NCT02683785|183045949|OTHER||Mean Difference (Net)|-5.5||||0.23|TWO_SIDED|95.0|-14.5|3.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 1|||3.6|-14.5|0.230
91578753|NCT02683785|183045949|OTHER||Mean Difference (Net)|-4.6||||0.381|TWO_SIDED|95.0|-15.2|5.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 2|||5.9|-15.2|0.381
91578754|NCT02683785|183045949|OTHER||Mean Difference (Net)|-8.7||||0.207|TWO_SIDED|95.0|-22.4|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 4|||5.0|-22.4|0.207
91578755|NCT02683785|183045949|OTHER||Mean Difference (Net)|-3.4||||0.648|TWO_SIDED|95.0|-18.4|11.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 6|||11.6|-18.4|0.648
91578756|NCT02683785|183045949|OTHER||Mean Difference (Net)|-9.0||||0.278|TWO_SIDED|95.0|-25.4|7.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 8|||7.5|-25.4|0.278
91578757|NCT02683785|183045949|OTHER||Mean Difference (Net)|-12.1||||0.16|TWO_SIDED|95.0|-29.1|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 10|||5.0|-29.1|0.160
91578758|NCT02683785|183045949|OTHER||Mean Difference (Net)|-13.3||||0.127|TWO_SIDED|95.0|-30.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 12|||3.9|-30.5|0.127
91578759|NCT02683785|183045950|OTHER||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.9|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||1.8|-1.9|0.957
91578760|NCT02683785|183045950|OTHER||Mean Difference (Net)|0.3||||0.775|TWO_SIDED|95.0|-2.1|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.8|-2.1|0.775
91578761|NCT02683785|183045950|OTHER||Mean Difference (Net)|-0.5||||0.624|TWO_SIDED|95.0|-2.7|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||1.7|-2.7|0.624
91578762|NCT02683785|183045950|OTHER||Mean Difference (Net)|1.4||||0.243|TWO_SIDED|95.0|-1.0|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.8|-1.0|0.243
91578763|NCT02683785|183045950|OTHER||Mean Difference (Net)|0.2||||0.875|TWO_SIDED|95.0|-2.5|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.9|-2.5|0.875
91578764|NCT02683785|183045950|OTHER||Mean Difference (Net)|-0.3||||0.848|TWO_SIDED|95.0|-3.4|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||2.8|-3.4|0.848
91578765|NCT02683785|183045950|OTHER||Mean Difference (Net)|-0.2||||0.883|TWO_SIDED|95.0|-2.8|2.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||2.4|-2.8|0.883
91578766|NCT02683785|183045951|OTHER||Mean Difference (Net)|-1.2||||0.463|TWO_SIDED|95.0|-4.4|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||2.0|-4.4|0.463
91578767|NCT02683785|183045951|OTHER||Mean Difference (Net)|-0.4||||0.809|TWO_SIDED|95.0|-3.7|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.9|-3.7|0.809
91578768|NCT02683785|183045951|OTHER||Mean Difference (Net)|-1.9||||0.324|TWO_SIDED|95.0|-5.8|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||2.0|-5.8|0.324
91578769|NCT02683785|183045951|OTHER||Mean Difference (Net)|-0.5||||0.783|TWO_SIDED|95.0|-4.2|3.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.2|-4.2|0.783
91578770|NCT02683785|183045951|OTHER||Mean Difference (Net)|-1.4||||0.464|TWO_SIDED|95.0|-5.4|2.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.5|-5.4|0.464
91578771|NCT02683785|183045951|OTHER||Mean Difference (Net)|-0.7||||0.736|TWO_SIDED|95.0|-4.9|3.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||3.5|-4.9|0.736
91578772|NCT02683785|183045951|OTHER||Mean Difference (Net)|-0.5||||0.806|TWO_SIDED|95.0|-4.8|3.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||3.7|-4.8|0.806
91578773|NCT02683785|183045952|OTHER||Mean Difference (Net)|0.3||||0.586|TWO_SIDED|95.0|-0.9|1.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||1.6|-0.9|0.586
91578774|NCT02683785|183045952|OTHER||Mean Difference (Net)|-0.5||||0.416|TWO_SIDED|95.0|-1.9|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.8|-1.9|0.416
91578775|NCT02683785|183045952|OTHER||Mean Difference (Net)|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.3|-2.8|0.120
91578776|NCT02683785|183045952|OTHER||Mean Difference (Net)|-0.3||||0.687|TWO_SIDED|95.0|-2.1|1.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||1.4|-2.1|0.687
91578777|NCT02683785|183045953|OTHER||Mean Difference (Net)|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented.|||0.8|-1.3|0.651
91578778|NCT02683785|183045953|OTHER||Mean Difference (Net)|-0.7||||0.271|TWO_SIDED|95.0|-1.9|0.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.5|-1.9|0.271
91578779|NCT02683785|183045953|OTHER||Mean Difference (Net)|-0.9||||0.186|TWO_SIDED|95.0|-2.2|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.4|-2.2|0.186
91578780|NCT02683785|183045953|OTHER||Mean Difference (Net)|-1.1||||0.109|TWO_SIDED|95.0|-2.4|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||0.2|-2.4|0.109
91578781|NCT01305408|183045967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2717|TWO_SIDED|95.0|-3.76|1.06||Statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||1.06|-3.76|0.2717
91578782|NCT02770612|183045990|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on discharge||||<0.001
91578783|NCT02233803|183045991|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) is demonstrated as the lower limit of CI for the difference is greater than the pre-specified NI margin of -1.25ML. The lower limit of the 95% CI for the treatment difference (NEUMOTEROL 400 -Symbicort Forte) was greater than the pre-specified non-inferiority margin of -1.25 mL.|Difference of LS means|0.044|||||TWO_SIDED|95.0|-0.008|0.096||||||Sample size calculations are based on the primary efficacy endpoint (change from baseline in trough FEV1 at day 29). Assuming a within-subject standard deviation of 210 mL, 168 completed subjects are required to demonstrate the non-inferiority of BFF 400/12 mcg SINGLE CAPSULE INHALER and BFF 320/9 mcg TURBUHALER BID, assuming a true difference of -50 mL with 90% power and a 2.5% one-sided significance level. The pre-specified NI margin is set at -1.25mL.||0.096|-0.008|
91578784|NCT02233803|183045992|SUPERIORITY_OR_OTHER||Difference of LS means|0.98|||||TWO_SIDED|95.0|0.576|1.384||||||||1.384|0.576|
91578785|NCT02233803|183045993|SUPERIORITY_OR_OTHER||Difference of LS means|0.6|||||TWO_SIDED|95.0|0.1|1.1||||||||1.1|0.1|
91578786|NCT03846453|183045994|SUPERIORITY||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.064||0.1871|TWO_SIDED|95.0|-0.04|0.21||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.21|-0.04|0.1871
91578787|NCT03846453|183045995|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5549|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|P-value calculated using a model with treatment, baseline score, and site as covariates.||||0.23|-0.12|0.5549
91578788|NCT06988800|183046082|SUPERIORITY||Odds Ratio (OR)|37.1|||<|0.001|TWO_SIDED||||||ANCOVA|||ANCOVAs and post hoc Tukey pairwise tests||||<.001
91578789|NCT06988800|183046083|SUPERIORITY||Odds Ratio (OR)|19.5|||<|0.001|TWO_SIDED||||||ANCOVA|||ANCOVAs and post hoc Tukey pairwise tests.||||<.001
91578790|NCT06988800|183046084|SUPERIORITY||Odds Ratio (OR)|18.7|||<|0.001|TWO_SIDED||||||ANCOVA|||ANCOVAs and post hoc Tukey pairwise tests||||<.001
91578791|NCT02344290|183046085|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.84|||||Hazard ratio is shown as pitavastatin/placebo. Two-sided 95% repeated confidence interval that adjusts for interim looks according to the realized Lan and DeMets implementation of the O'Brien-Fleming sequential stopping boundary is presented.|||0.84|0.48|
91578792|NCT02344290|183046086|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.36|0.87|||||Hazard ratio is shown as pitavastatin/placebo.|||0.87|0.36|
91578793|NCT02344290|183046087|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.4|0.97|||||Hazard ratio is shown as pitavastatin/placebo.|||0.97|0.40|
91578794|NCT02344290|183046088|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.11|4.02|||||Hazard ratio is shown as pitavastatin/placebo.|||4.02|0.11|
91578795|NCT02344290|183046089|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.35|1.38|||||Hazard ratio is shown as pitavastatin/placebo.|||1.38|0.35|
91578796|NCT02344290|183046090|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||Hazard ratio is shown as pitavastatin/placebo.|||1.03|0.44|
91578797|NCT02344290|183046091|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.36|1.05|||||||Hazard ratio is shown as pitavastatin/placebo.|1.05|0.36|
91578798|NCT02344290|183046093|SUPERIORITY||Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||||Hazard ratio is shown as pitavastatin/placebo. Estimation of the confidence interval used a Bayes analysis with a non-informative prior using adaptive rejection Metropolis sampling. In this case, the interval shown is a 95% highest posterior density (HPD) interval.|0.54|0.00|
91578799|NCT02344290|183046094|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.64|0.94|||||Hazard ratio is shown as pitavastatin/placebo.|||0.94|0.64|
91578800|NCT02344290|183046095|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.7|1.12|||||Hazard ratio is shown as pitavastatin/placebo.|||1.12|0.70|
91578801|NCT02344290|183046096|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.76|1.13|||||Hazard ratio is shown as pitavastatin/placebo.|||1.13|0.76|
91578802|NCT02344290|183046097|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||||Hazard ratio is shown as pitavastatin/placebo.|||1.20|0.71|
91578803|NCT02344290|183046098|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.68|1.31|||||Hazard ratio is shown as pitavastatin/placebo.|||1.31|0.68|
91578804|NCT02344290|183046099|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.14|2.51|||||Hazard ratio is shown as pitavastatin/placebo.|||2.51|0.14|
91578805|NCT02344290|183046100|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.42|2.02|||||Hazard ratio is shown as pitavastatin/placebo.|||2.02|0.42|
91578806|NCT02344290|183046101|SUPERIORITY||Incidence rate ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.10|0.90|
91578807|NCT02344290|183046102|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.07|1.57|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.57|1.07|
91578808|NCT02344290|183046103|SUPERIORITY||Incidence rate ratio|1.58|||||TWO_SIDED|95.0|1.14|2.19|||||Incidence rate ratio is shown as pitavastatin/placebo.|||2.19|1.14|
91578809|NCT02344290|183046104|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.17|3.37|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.37|0.17|
91578810|NCT02344290|183046105|SUPERIORITY||Incidence rate ratio|1.34|||||TWO_SIDED|95.0|0.56|3.18|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.18|0.56|
91578811|NCT02344290|183046106|SUPERIORITY||Incidence rate ratio|1.04|||||TWO_SIDED|95.0|0.97|1.12|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.12|0.97|
91578812|NCT02344290|183046109|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.52|1.08|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.08|0.52|
91578813|NCT02344290|183046110|SUPERIORITY||Incidence rate ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.16|0.96|
91578814|NCT02344290|183046111|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.6|-0.1|||Regression, Linear||Treatment group difference was estimated as baseline-adjusted mean difference in change at year 2, using linear regression.|||-0.1|-8.6|0.04
91578815|NCT02344290|183046112|SUPERIORITY||Risk Ratio (RR)|0.67||||0.003|TWO_SIDED|95.0|0.52|0.88|||Chi-squared||Treatment effect was estimated as relative risk (pitavastatin/placebo), adjusted for presence of NCP at entry.|||0.88|0.52|0.003
91578816|NCT02344290|183046113|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.2|0.62|||||Treatment group difference was estimated as baseline-adjusted difference in mean change at year 2, using linear regression.|||0.62|-9.2|
91578817|NCT02344290|183046114|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of LpPla2 Levels at Month 24||||<0.001
91578818|NCT02344290|183046115|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in LpPla2 from Baseline at Month 24||||<0.001
91578819|NCT02344290|183046116|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparison of hsCRP Levels at Month 24||||0.02
91578820|NCT02344290|183046117|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in hsCRP from Baseline at Month 24||||0.09
91578821|NCT02344290|183046118|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Comparison of soluble CD163 Levels at Month 24.||||0.65
91578822|NCT02344290|183046119|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in soluble CD163 from Baseline at Month 24||||0.88
91578823|NCT02344290|183046120|SUPERIORITY|||||||0.98|||||||Regression, Cox|Treatment effect modification by sex was evaluated via interaction of treatment and sex in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by sex (i.e. pitavastatin effect differing in females compared to males).||||0.98
91578824|NCT02344290|183046120|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.39|1.04|||||Hazard ratio is shown as pitavastatin/placebo among females.|Evaluation of pitavastatin effect among females.||1.04|0.39|
91578825|NCT02344290|183046120|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Hazard ratio is shown as pitavastatin/placebo among males.|Evaluation of pitavastatin effect among males.||0.86|0.48|
91578826|NCT02344290|183046121|SUPERIORITY|||||||0.14|||||||Regression, Cox|Treatment effect modification by race was evaluated via interaction of treatment and race in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by race (i.e. pitavastatin effect differing between races).||||0.14
91578827|NCT02344290|183046121|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.09|0.59||||||Pitavastatin effect among Asians from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Asians.|0.59|0.09|
91578828|NCT02344290|183046121|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.96|||||Hazard ratio is shown as pitavastatin/placebo among Blacks.|Pitavastatin effect among Blacks from subgroup analysis by race.||0.96|0.46|
91578829|NCT02344290|183046121|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Hazard ratio is shown as pitavastatin/placebo among Whites.|Pitavastatin effect among Whites from subgroup analysis by race.||1.13|0.49|
91578830|NCT02344290|183046121|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.36|2.1||||||Pitavastatin effect among Other race from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Other race.|2.10|0.36|
91578831|NCT00503139|183046221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
91578832|NCT00503139|183046222|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
91578833|NCT00091169|183046226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
91578834|NCT00091169|183046227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.64
91578835|NCT00091169|183046228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.93
91578836|NCT00091169|183046229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
91578837|NCT00091169|183046230|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Fisher Exact|||||||0.00001
91578838|NCT00091169|183046231|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||||||0.677
91578839|NCT04410523|183046269|SUPERIORITY||Least Squares mean|0.122|STANDARD_ERROR_OF_MEAN|0.0541||0.025|TWO_SIDED|95.0|0.016|0.229|||MMRM||Treatment difference (CSJ117-placebo)|||0.229|0.016|0.025
91578840|NCT04410523|183046269|SUPERIORITY||Least Squares mean|0.058|STANDARD_ERROR_OF_MEAN|0.0542||0.286|TWO_SIDED|95.0|-0.049|0.165|||MMRM||Treatment difference (CCSJ117-placebo)|||0.165|-0.049|0.286
91578841|NCT04410523|183046269|SUPERIORITY||Least Squares mean|0.065|STANDARD_ERROR_OF_MEAN|0.0521||0.212|TWO_SIDED|95.0|-0.037|0.168|||MMRM||Treatment difference (CCSJ117-placebo)|||0.168|-0.037|0.212
91578842|NCT04410523|183046269|SUPERIORITY||Least Squares mean|0.009|STANDARD_ERROR_OF_MEAN|0.043||0.831|TWO_SIDED|95.0|-0.076|0.094|||MMRM||Treatment difference (CCSJ117-placebo)|||0.094|-0.076|0.831
91578843|NCT04410523|183046269|SUPERIORITY||Least Squares mean|-0.008|STANDARD_ERROR_OF_MEAN|0.0434||0.852|TWO_SIDED|95.0|-0.094|0.077|||MMRM||Treatment difference (CCSJ117-placebo)|||0.077|-0.094|0.852
91578844|NCT04410523|183046270|SUPERIORITY||Least Squares mean|-1.568|STANDARD_ERROR_OF_MEAN|2.363||0.508|TWO_SIDED|95.0|-6.219|3.083|||MMRM||Treatment difference (CSJ117-placebo)|||3.083|-6.219|0.508
91578845|NCT04410523|183046270|SUPERIORITY||Least Squares mean|-3.998|STANDARD_ERROR_OF_MEAN|2.384||0.095|TWO_SIDED|95.0|-8.691|0.695|||MMRM||Treatment difference (CCSJ117-placebo)|||0.695|-8.691|0.095
91578846|NCT04410523|183046270|SUPERIORITY||Least Squares mean|-2.889|STANDARD_ERROR_OF_MEAN|2.2943||0.209|TWO_SIDED|95.0|-7.405|1.627|||MMRM||Treatment difference (CCSJ117-placebo)|||1.627|-7.405|0.209
91578847|NCT04410523|183046270|SUPERIORITY||Least Squares mean|-0.287|STANDARD_ERROR_OF_MEAN|1.8718||0.878|TWO_SIDED|95.0|-3.971|3.398|||MMRM||Treatment difference (CCSJ117-placebo)|||3.398|-3.971|0.878
91578848|NCT04410523|183046270|SUPERIORITY||Least Squares mean|1.093|STANDARD_ERROR_OF_MEAN|1.8652||0.558|TWO_SIDED|95.0|-2.578|4.765|||MMRM||Treatment difference (CCSJ117-placebo)|||4.765|-2.578|0.558
91578849|NCT04410523|183046273|SUPERIORITY||Least Squares mean|-0.042|STANDARD_ERROR_OF_MEAN|0.1493||0.78|TWO_SIDED|95.0|-0.336|0.252|||MMRM||Treatment difference (CSJ117-placebo)|||0.252|-0.336|0.780
91578850|NCT04410523|183046273|SUPERIORITY||Least Squares mean|-0.42|STANDARD_ERROR_OF_MEAN|0.1489||0.005|TWO_SIDED|95.0|-0.713|-0.127|||MMRM||Treatment difference (CCSJ117-placebo)|||-0.127|-0.713|0.005
91578851|NCT04410523|183046273|SUPERIORITY||Least Squares mean|-0.289|STANDARD_ERROR_OF_MEAN|0.1446||0.047|TWO_SIDED|95.0|-0.573|0.004|||MMRM||Treatment difference (CCSJ117-placebo)|||0.004|-0.573|0.047
91578852|NCT04410523|183046273|SUPERIORITY||Least Squares mean|-0.017|STANDARD_ERROR_OF_MEAN|0.1182||0.887|TWO_SIDED|95.0|-0.249|0.216|||MMRM||Treatment difference (CCSJ117-placebo)|||0.216|-0.249|0.887
91578853|NCT04410523|183046273|SUPERIORITY||Least Squares mean|-0.115|STANDARD_ERROR_OF_MEAN|0.1184||0.333|TWO_SIDED|95.0|-0.348|0.118|||MMRM||Treatment difference (CCSJ117-placebo)|||0.118|-0.348|0.333
91578854|NCT04410523|183046274|SUPERIORITY||Least Squares mean|-0.097|STANDARD_ERROR_OF_MEAN|0.1485||0.515|TWO_SIDED|95.0|-0.389|0.195|||MMRM||Treatment difference (CSJ117-placebo)|||0.195|-0.389|0.515
91578855|NCT04410523|183046274|SUPERIORITY||Least Squares mean|0.218|STANDARD_ERROR_OF_MEAN|0.1484||0.143|TWO_SIDED|95.0|-0.074|0.51|||MMRM||Treatment difference (CCSJ117-placebo)|||0.510|-0.074|0.143
91578856|NCT04410523|183046274|SUPERIORITY||Least Squares mean|0.078|STANDARD_ERROR_OF_MEAN|0.145||0.59|TWO_SIDED|95.0|-0.207|0.364|||MMRM||Treatment difference (CCSJ117-placebo)|||0.364|-0.207|0.590
91578857|NCT04410523|183046274|SUPERIORITY||Least Squares mean|0.033|STANDARD_ERROR_OF_MEAN|0.118||0.778|TWO_SIDED|95.0|-0.199|0.265|||MMRM||Treatment difference (CCSJ117-placebo)|||0.265|-0.199|0.778
91578858|NCT04410523|183046274|SUPERIORITY||Least Squares mean|0.073|STANDARD_ERROR_OF_MEAN|0.118||0.539|TWO_SIDED|95.0|-0.16|0.305|||MMRM||Treatment difference (CCSJ117-placebo)|||0.305|-0.160|0.539
91578859|NCT00734591|183046294|SUPERIORITY_OR_OTHER||Exact method|2.81|||||TWO_SIDED|95.0|0.5|28.46|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||28.46|0.50|
91578860|NCT00734591|183046295|SUPERIORITY_OR_OTHER||Exact method|2.29|||||TWO_SIDED|95.0|0.37|24.01|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||24.01|0.37|
91578861|NCT00734591|183046296|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
91578862|NCT00734591|183046297|SUPERIORITY_OR_OTHER||Exact method|3.75|||||TWO_SIDED|95.0|1.01|20.68|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||20.68|1.01|
91578863|NCT00799981|183046350|OTHER|||||||0.8762|||||||Wilcoxon (Mann-Whitney)|||The hypothesis that a 10 cm catheter provides equal emptying of the bladder as a 7 cm catheter was tested.||||0.8762
91578864|NCT00799981|183046351|OTHER|||||||0.7905|||||||McNemar|||||||0.7905
91578865|NCT00799981|183046352|OTHER|||||||1|||||||McNemar|||||||1.00
91578866|NCT00799981|183046355|OTHER|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||In the table 0=No and 1=Yes.||||0.0273
91578867|NCT03192475|183046356|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
91578868|NCT03192475|183046357|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
91578869|NCT03192475|183046358|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
91578870|NCT03192475|183046359|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
91578871|NCT03192475|183046360|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
91578872|NCT03192475|183046361|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
91578873|NCT03192475|183046362|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
91578874|NCT03192475|183046363|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
91578875|NCT03192475|183046364|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
91578876|NCT03192475|183046365|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
91578877|NCT03192475|183046366|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
91578878|NCT03192475|183046367|SUPERIORITY|||||||0.0009|||||||Mantel Haenszel|||||||0.0009
91578879|NCT03192475|183046368|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.18
91578880|NCT03192475|183046369|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
91578881|NCT03192475|183046370|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
91578882|NCT01404429|183046373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.6|TWO_SIDED|95.0|-0.26|0.54|||t-test, 2 sided|||||0.54|-0.26|0.6
91578883|NCT03653208|183046389|OTHER||Slope|1.01||||0.1075|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.1075
91578884|NCT03653208|183046390|OTHER||Slope|1.2||||0.0548|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.0548
91578885|NCT00368927|183046391|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher Exact|||With a sample size of 60 evaluable participants per intervention arm, we would have 90% power to detect a bronchial dysplasia response rate of 54% and 82% power to detect a bronchial dysplasia response rate of\> 51% among participants assigned to receive active sulindac (2-sided chi-square test with continuity correction; alpha=0.05).||||0.85
91578886|NCT00368927|183046392|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||A sample size of 60 participants per intervention arm would provide 90% power and 80% power to detect effect sizes of 60% and 52%, respectively, using a two-sample t-test(alpha=0.05).||||0.63
91578887|NCT01204710|183046399|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.29||||0.2201|TWO_SIDED|95.0|0.87|1.9||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as IMC-3G3 + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.90|0.87|0.2201
91578888|NCT01204710|183046400|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.7291|TWO_SIDED|95.0|0.72|1.61||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as Olaratumab + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.61|0.72|0.7291
91578889|NCT01204710|183046401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3465|TWO_SIDED||||||Fisher Exact|||||||0.3465
91578890|NCT01204710|183046402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6571|TWO_SIDED||||||Fisher Exact|||||||0.6571
91578891|NCT01204710|183046403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Fisher Exact|||||||0.4986
91578892|NCT01989169|183046415|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.215|||||TWO_SIDED|90.0|1.116|1.323|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.323|1.116|
91578893|NCT01989169|183046416|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.216|||||TWO_SIDED|90.0|1.115|1.327|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.327|1.115|
91578894|NCT01989169|183046417|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.383|||||TWO_SIDED|90.0|1.282|1.491|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.491|1.282|
91578895|NCT01114880|183046418|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91578896|NCT01114880|183046420|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91578897|NCT01114880|183046422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91578898|NCT01114880|183046424|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91578899|NCT01114880|183046426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
91514175|NCT04079933|182900465|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-9.83||||0.406|TWO_SIDED|95.0|-33.2|13.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||13.5|-33.2|0.4060
91578900|NCT01114880|183046428|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||< 0.001
91578901|NCT01114880|183046430|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
91578902|NCT01114880|183046432|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
91578903|NCT01114880|183046434|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
91578904|NCT01114880|183046436|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
91578905|NCT01114880|183046438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
91578906|NCT03361605|183046485|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli."|Mean Difference (Net)|-0.349|STANDARD_DEVIATION|0.223|<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline.||||<0.0001
91578907|NCT03361605|183046486|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the squeeze pressure in response to verbal instructions."|Mean Difference (Net)|-2.16|STANDARD_DEVIATION|3.09||0.00148|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|The null hypothesis is no difference in squeeze pressure between sedated state and baseline.||||0.00148
91578908|NCT03898167|183046487|OTHER||Relative Participation|2.36|||||TWO_SIDED|95.0|1.99|2.8||95% CIs were calculated.||||Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.||2.80|1.99|
91578909|NCT04696653|183046519|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
91578910|NCT04696653|183046520|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.2|1.8||||||hypertension||1.8|0.2|
91578911|NCT04696653|183046520|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|0.0|2.1||||||dyslipidemia||2.1|0.0|
91578912|NCT04696653|183046520|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.1|2.0||||||diabetes||2.0|0.1|
91578913|NCT04696653|183046521|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Evidenced based practice||0.1|-0.6|
91578914|NCT04696653|183046521|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||CUSP strategy||0.1|-0.6|
91578915|NCT04696653|183046522|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.2||||||CUSP strategy||0.2|-0.6|
91578916|NCT04696653|183046522|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Evidenced based practice||0.1|-0.5|
91578917|NCT04696653|183046523|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||evidenced based practice||0.1|-0.5|
91578918|NCT04696653|183046523|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.5|0.2||||||CUSP strategy||0.2|-0.5|
91578919|NCT04696653|183046524|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.9|2.2||||||||2.2|0.9|
91578920|NCT04696653|183046525|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.1|1.9||||||||1.9|1.1|
91578921|NCT04696653|183046526|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.7|1.4||||||||1.4|0.7|
91578922|NCT04696653|183046527|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
91578923|NCT04696653|183046532|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.0|1.6||||||||1.6|1.0|
91578924|NCT04696653|183046533|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
91578925|NCT04696653|183046534|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
91578926|NCT04696653|183046535|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
91578927|NCT04696653|183046536|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
91578928|NCT04696653|183046537|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
91578929|NCT04696653|183046538|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
91578930|NCT04696653|183046539|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
91578931|NCT04696653|183046540|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||||0.2|-0.1|
91578932|NCT04696653|183046541|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
91578933|NCT04696653|183046542|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.4|0.0||||||||0.0|-0.4|
91578934|NCT04696653|183046543|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.0|3.3||||||||3.3|1.0|
91578935|NCT04348435|183046559|SUPERIORITY||Mean Difference (Net)|0.253|STANDARD_ERROR_OF_MEAN|0.49||0.6113|TWO_SIDED|95.0|||||ANCOVA|||||||0.6113
91578936|NCT04348435|183046559|SUPERIORITY||Mean Difference (Net)|-0.434|STANDARD_ERROR_OF_MEAN|0.638||0.5039|TWO_SIDED|95.0|||||ANCOVA|||||||0.5039
91578937|NCT04348435|183046559|SUPERIORITY||Mean Difference (Net)|0.077|STANDARD_ERROR_OF_MEAN|0.555||0.8903|TWO_SIDED|95.0|||||ANCOVA|||||||0.8903
91578938|NCT04348435|183046560|SUPERIORITY||Mean Difference (Net)|-0.247|STANDARD_ERROR_OF_MEAN|1.056||0.8171|TWO_SIDED|95.0|||||ANCOVA|||||||0.8171
91578939|NCT04348435|183046560|SUPERIORITY||Mean Difference (Net)|-0.913|STANDARD_ERROR_OF_MEAN|1.342||0.5034|TWO_SIDED|95.0|||||ANCOVA|||||||0.5034
91578940|NCT04348435|183046560|SUPERIORITY||Mean Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|1.193||0.9948|TWO_SIDED|95.0|||||ANCOVA|||||||0.9948
91578941|NCT04348435|183046561|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.156||0.2641|TWO_SIDED|95.0|||||ANCOVA|||||||0.2641
91578942|NCT04348435|183046561|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.198||0.822|TWO_SIDED|95.0|||||ANCOVA|||||||0.8220
91578943|NCT04348435|183046561|SUPERIORITY||Median Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.171||0.3097|TWO_SIDED|95.0|||||ANCOVA|||||||0.3097
91578944|NCT04348435|183046562|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.07||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
91578945|NCT04348435|183046562|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.087||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
91578946|NCT04348435|183046562|SUPERIORITY||Mean Difference (Net)|0.112|STANDARD_ERROR_OF_MEAN|0.079||0.1713|TWO_SIDED|95.0|||||ANCOVA|||||||0.1713
91578947|NCT04348435|183046563|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.091||0.3868|TWO_SIDED|95.0|||||ANCOVA|||||||0.3868
91578948|NCT04348435|183046563|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.115||0.9429|TWO_SIDED|95.0|||||ANCOVA|||||||0.9429
91578949|NCT04348435|183046563|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.103||0.9362|TWO_SIDED|95.0|||||ANCOVA|||||||0.9362
91578950|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|-0.708|STANDARD_ERROR_OF_MEAN|8.38||0.9333|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.9333
91578951|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|8.78|STANDARD_ERROR_OF_MEAN|9.483||0.3627|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.3627
91578952|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|6.282|STANDARD_ERROR_OF_MEAN|7.604||0.416|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.4160
91578953|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.32||0.8768|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.8768
91578954|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|-7.719|STANDARD_ERROR_OF_MEAN|4.344||0.0869|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.0869
91578955|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|3.514||0.6864|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.6864
91578956|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|-4.12|STANDARD_ERROR_OF_MEAN|3.571||0.2587|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.2587
91578957|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|8.417|STANDARD_ERROR_OF_MEAN|5.316||0.125|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.1250
91578958|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|-0.104|STANDARD_ERROR_OF_MEAN|3.732||0.978|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.9780
91578959|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|0.963|STANDARD_ERROR_OF_MEAN|5.925||0.8721|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.8721
91578960|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|7.735||0.6694|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.6694
91578961|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|5.498|STANDARD_ERROR_OF_MEAN|6.073||0.3733|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.3733
91578962|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|2.433|STANDARD_ERROR_OF_MEAN|4.116||0.5594|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.5594
91578963|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|6.878|STANDARD_ERROR_OF_MEAN|5.389||0.2127|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.2127
91578964|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|3.67|STANDARD_ERROR_OF_MEAN|4.303||0.4012|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.4012
91578965|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|11.678|STANDARD_ERROR_OF_MEAN|5.748||0.0521|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0521
91578966|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|5.635|STANDARD_ERROR_OF_MEAN|7.696||0.4704|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.4704
91578967|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|12.101|STANDARD_ERROR_OF_MEAN|6.017||0.0544|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0544
91578968|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|2.333|STANDARD_ERROR_OF_MEAN|3.888||0.5535|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5535
91578969|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|3.689|STANDARD_ERROR_OF_MEAN|4.969||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.4642
91578970|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|2.268|STANDARD_ERROR_OF_MEAN|3.936||0.5692|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5692
91578971|NCT04348435|183046564|SUPERIORITY||Median Difference (Net)|2.667|STANDARD_ERROR_OF_MEAN|3.592||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||0.4642
91578972|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|4.444||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
91578973|NCT04348435|183046564|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|3.526||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
91578974|NCT04348435|183046565|SUPERIORITY||Mean Difference (Net)|-0.144|STANDARD_ERROR_OF_MEAN|0.825||0.8628|TWO_SIDED|95.0|||||ANCOVA|||||||0.8628
91578975|NCT04348435|183046565|SUPERIORITY||Mean Difference (Net)|-0.605|STANDARD_ERROR_OF_MEAN|0.94||0.5257|TWO_SIDED|95.0|||||ANCOVA|||||||0.5257
91578976|NCT04348435|183046565|SUPERIORITY||Mean Difference (Net)|-0.403|STANDARD_ERROR_OF_MEAN|0.659||0.5467|TWO_SIDED|95.0|||||ANCOVA|||||||0.5467
91578977|NCT00660543|183046581|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.003
91578978|NCT00660543|183046581|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.008
91578979|NCT03921723|183046606|EQUIVALENCE|Bioequivalence is established when the 90 percent (%) confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
91578980|NCT03921723|183046606|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.12|||||TWO_SIDED|90.0|1.05|1.2||||||||1.20|1.05|
91578981|NCT03921723|183046625|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
91578982|NCT03921723|183046625|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.13||||||90.0|1.06|1.2||||||||1.20|1.06|
91578983|NCT03921723|183046626|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.09|||||TWO_SIDED|90.0|1.01|1.19||||||||1.19|1.01|
91578984|NCT03921723|183046626|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.22|||||TWO_SIDED|90.0|1.13|1.33||||||||1.33|1.13|
91578985|NCT04091061|183046649|OTHER|90% Confidence Intervals (CIs) for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.99|||||TWO_SIDED|90.0|83.14|296.44|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference.|||296.44|83.14|
91578986|NCT04091061|183046649|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|125.58|||||TWO_SIDED|90.0|66.51|237.13|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||237.13|66.51|
91578987|NCT04091061|183046649|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|123.75|||||TWO_SIDED|90.0|65.54|233.68|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||233.68|65.54|
91578988|NCT04091061|183046650|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.25|||||TWO_SIDED|90.0|81.07|301.16|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||301.16|81.07|
91578989|NCT04091061|183046650|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.66|||||TWO_SIDED|90.0|85.95|319.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||319.29|85.95|
91578990|NCT04091061|183046650|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.18|||||TWO_SIDED|90.0|78.96|293.32|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.32|78.96|
91578991|NCT04091061|183046651|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.0|||||TWO_SIDED|90.0|80.95|300.6|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||300.60|80.95|
91578992|NCT04091061|183046651|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.38|||||TWO_SIDED|90.0|85.82|318.67|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||318.67|85.82|
91578993|NCT04091061|183046651|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.2|||||TWO_SIDED|90.0|78.99|293.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.29|78.99|
91578994|NCT00406692|183046656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.0003|TWO_SIDED|95.0||||Null Hypothesis: No difference in the mean daily standard drinks consumed for the baseline period and the zonisamide treatment weeks|Mixed Models Analysis|||Null Hypothesis: No difference in the mean daily standard drinks consumed between the baseline period and the zonisamide treatment weeks.||||<0.0003
91578995|NCT00406692|183046657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|3.9|<|0.22|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant change in the mean number of words produced during phonetic portion of the Controlled Word Association Test between the baseline period and the treatment weeks.||||<0.22
91578996|NCT00406692|183046658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.55|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant difference for mean scores obtained for baseline, week 4 and week 12.||||< 0.55
91578997|NCT04488770|183046707|OTHER||Ratio of Geometric Mean|0.75|||||TWO_SIDED|90.0|0.61|0.93|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-24). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Unstructured covariance structure is used.|||0.93|0.61|
91578998|NCT04488770|183046708|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
91578999|NCT04488770|183046709|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for log transformed parameter AUC(0-infinity). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
91579000|NCT04488770|183046710|OTHER||Ratio of Geometric Mean|0.59|||||TWO_SIDED|90.0|0.46|0.75|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.75|0.46|
91579001|NCT04488770|183046711|OTHER||Ratio of Geometric Mean|0.91|||||TWO_SIDED|90.0|0.74|1.11|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter C24h. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||1.11|0.74|
91579002|NCT04488770|183046712|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tmax.|||2.000|0.000|
91579003|NCT04488770|183046713|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tlag.|||0.250|0.000|
91579004|NCT03547739|183046714|SUPERIORITY||Risk Ratio (RR)|4.22|||<|0.001|TWO_SIDED|95.0|2.88|6.18|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|Home visits as compared to Standard Care||6.18|2.88|<0.001
91579005|NCT03547739|183046714|SUPERIORITY||Risk Ratio (RR)|3.69|||<|0.001|TWO_SIDED|95.0|2.5|5.45|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|HIV Self-testing as compared to Standard Care||5.45|2.50|<0.001
91579006|NCT03547739|183046715|SUPERIORITY||Risk Ratio (RR)|1.21||||0.001|TWO_SIDED|95.0|1.12|1.31|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.31|1.12|.001
91579007|NCT03547739|183046715|SUPERIORITY||Risk Ratio (RR)|1.26||||0.001|TWO_SIDED|95.0|1.17|1.36|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of HIVST arm with Standard Care arm||1.36|1.17|.001
91579008|NCT03547739|183046729|SUPERIORITY||Risk Ratio (RR)|1.08||||0.011|TWO_SIDED|95.0|1.03|1.12|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.12|1.03|.011
91579009|NCT03547739|183046729|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|0.97|1.08|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the HIVST arm with Standard Care||1.08|0.97|0.011
91579010|NCT03547739|183046730|OTHER||Kaplan Meier estimates|0.92||||0.087|TWO_SIDED|95.0|0.86|0.95|||Log Rank|||||0.95|0.86|0.087
91579011|NCT03547739|183046730|OTHER||Kaplan Meier estimates|0.96||||0.087|TWO_SIDED|95.0|0.91|0.98|||Log Rank|||||0.98|0.91|0.087
91579012|NCT03547739|183046730|OTHER||Kaplan Meier estimates|0.98||||0.087|TWO_SIDED|95.0|0.93|0.99|||Log Rank|||||0.99|0.93|0.087
91579013|NCT01696955|183046733|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
91579014|NCT01696955|183046736|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
91579015|NCT01696955|183046737|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
91579016|NCT01696955|183046738|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
91579017|NCT03980808|183046744|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.56||0.95|TWO_SIDED||||||ANOVA|Total degrees of freedom (dof) = 17, with between groups dof = 1 and within groups dof = 16.||Composite scores were calculated for the knowledge based tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.95
91579018|NCT03980808|183046745|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.5376||0.093|TWO_SIDED||||||ANOVA|||Composite scores were calculated for the behavioral self-report tests tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.093
91579019|NCT00573859|183046783|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||A 2 (ADHD medication versus Placebo) repeated measure ANOVA||||<0.05
91579020|NCT00573859|183046784|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Four-way repeated measure ANOVA||||<0.05
91579021|NCT00573859|183046785|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Friedman's two analysis of ranks|||Friedman's two-way analysis of variance by ranks.||||<0.05
91579022|NCT02729831|183046804|SUPERIORITY||Mean Difference (Net)|9.0|||<|0.001|TWO_SIDED|95.0|6.0|12.0|||Regression, Linear|||The comparison groups were: Interactive decision versus Video decision aid.||12|6|<0.001
91579023|NCT02729831|183046805|SUPERIORITY||Odds Ratio (OR)|1.03||||0.86|TWO_SIDED|95.0|0.74|1.44|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.||1.44|0.74|0.86
91579024|NCT02729831|183046805|SUPERIORITY||Odds Ratio (OR)|1.06||||0.75|TWO_SIDED|95.0|0.76|1.47|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid||1.47|0.76|0.75
91579025|NCT02729831|183046806|SUPERIORITY||Risk Difference (RD)|18.5|||<|0.001|TWO_SIDED|95.0|12.8|24.5|||Chi-squared|Compared patients who reported using all of the DA compared to everyone else.||Comparison groups were: patients who reported using all of the DA versus everyone else.||24.5|12.8|<0.001
91579026|NCT02729831|183046807|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED|95.0|0.016|0.065|||Regression, Linear|Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint.||We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.||0.065|0.016|<0.001
91579027|NCT02729831|183046808|SUPERIORITY||Odds Ratio (OR)|25.7|||<|0.001|TWO_SIDED|95.0|16.5|40.1|||Regression, Logistic|General estimating equations were used to account for clustering of patients within surgeons.||We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.||40.1|16.5|<0.001
91579028|NCT00864253|183046809|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.792||||0.044|TWO_SIDED|95.1|0.631|0.992||An interim safety review was performed by DMC. An alpha spending function was utilized to preserve the overall Type 1 error at 0.050. The spending function allocated alpha of 0.001 and 0.049 to the interim and final analyses of PFS, respectively.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||Two hundred fifty-seven (257) patients were to be randomized to each treatment group for a total of 514 patients. This sample size was chosen to provide at least 80% power for the final analysis (with a two-sided type I error of 0.049) to reject the null hypothesis that the ABI 007/dacarbazine hazard ratio (HR) for PFS is equal to 1.0. This sample size calculation was based on estimates of HR = 0.750. Proportional hazards were assumed.||0.992|0.631|0.044
91579029|NCT00864253|183046810|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.094|TWO_SIDED|99.9|0.578|1.196||At the time of the final PFS analysis, an interim analysis of survival was reported. The spending function allocated an alpha of 0.001 and 0.049 for the interim and final analysis, respectively, to preserve the overall Type I error at 0.050.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||For the participant survival, at the time at least 417 events are recorded, this sample size provides at least 80% power with a two-sided Type 1 error of 0.049 to reject the null hypothesis that the ABI-007/dacarbazine hazard ratio is equal to 1.0. This was based on a HR = 0.760. Proportional hazards were assumed.||1.196|0.578|0.094
91579030|NCT00864253|183046811|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.845||||0.086|TWO_SIDED|95.0|0.696|1.025|||Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||||1.025|0.696|0.086
91579031|NCT00864253|183046812|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.305||||0.239|TWO_SIDED|95.0|0.837|2.035|||Chi-squared|||||2.035|0.837|0.239
91579032|NCT00864253|183046813|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.442||||0.004|TWO_SIDED|95.0|1.123|1.582|||Chi-squared|||||1.582|1.123|0.004
91579033|NCT00864253|183046814|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.201||||0.057|TWO_SIDED|95.0|0.959|5.053|||Log Rank|||||5.053|0.959|0.057
91579034|NCT01747551|183046841|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
91579035|NCT05384938|183046900|OTHER|Single group|Median time to response|100.0|||||TWO_SIDED|95.0|65.0|160.0|||||Estimate for Time to Response using Kaplan-Meier method|Estimate for Time to Response (Days)||160.0|65.00|
91579036|NCT05384938|183046904|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 4 (Visit 2)||||<0.0001
91579037|NCT05384938|183046904|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 16 (Visit 4)||||<0.0001
91579038|NCT05384938|183046904|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 24 (Visit 5)||||<0.0001
91579039|NCT02626455|183046906|SUPERIORITY|Comparison of PFS|Hazard Ratio (HR)|1.125|||=|0.827974|TWO_SIDED|95.0|0.881|1.437||Significance level is 0.025.|Log Rank|PFS was evaluated with a one-sided stratified log- rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.437|0.881|= 0.827974
91579040|NCT02626455|183046909|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-1.25|||=|0.658652|TWO_SIDED|95.0|-7.25|4.75||Significance level is 0.025. P-values are descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||4.75|-7.25|= 0.658652
91579041|NCT02626455|183046910|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-0.8|||=|0.605183|TWO_SIDED|95.0|-6.64|5.05||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.05|-6.64|=0.605183
91579042|NCT02626455|183046911|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.145|||=|0.846204|TWO_SIDED|95.0|0.883|1.484||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.484|0.883|= 0.846204
91579043|NCT02626455|183046912|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.117|||=|0.801735|TWO_SIDED|95.0|0.865|1.443||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.443|0.865|= 0.801735
91579044|NCT02626455|183046913|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.74|||=|0.741153|TWO_SIDED|95.0|-11.06|5.57||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.57|-11.06|= 0.741153
91579045|NCT02626455|183046914|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.21|||=|0.696482|TWO_SIDED|95.0|-10.62|6.2||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||6.20|-10.62|= 0.696482
91579046|NCT02626455|183046915|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.95|||=|0.936009|TWO_SIDED|95.0|-9.04|1.14||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||1.14|-9.04|= 0.936009
91579047|NCT02626455|183046916|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.89|||=|0.944242|TWO_SIDED|95.0|-8.68|0.9||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||0.90|-8.68|= 0.944242
91579048|NCT02626455|183046917|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|1.006|||=|0.517849|TWO_SIDED|95.0|0.777|1.303||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.303|0.777|= 0.517849
91579049|NCT02626455|183046918|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|0.971|||=|0.411398|TWO_SIDED|95.0|0.75|1.257||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.257|0.750|= 0.411398
91579050|NCT02626455|183046919|SUPERIORITY|Comparison of TTNT|Hazard Ratio (HR)|1.289|||=|0.955865|TWO_SIDED|95.0|0.962|1.728||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTNT was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.728|0.962|= 0.955865
91579051|NCT02626455|183046920|SUPERIORITY|Comparison of OS|Hazard Ratio (HR)|1.132|||=|0.758563|TWO_SIDED|95.0|0.8|1.603||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|OS was evaluated with a one-sided stratified log-rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.603|0.800|= 0.758563
91579052|NCT02626455|183046921|SUPERIORITY|Comparison of time to deterioration in DRS-P|Hazard Ratio (HR)|1.394|||=|0.999695|TWO_SIDED|95.0|1.149|1.691||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to deterioration in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on stratified Cox regression model.||||1.691|1.149|= 0.999695
91579053|NCT02626455|183046922|SUPERIORITY|Comparison of time to improvement in DRS-P|Hazard Ratio (HR)|0.81|||=|0.965639|TWO_SIDED|95.0|0.642|1.02||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to improvement in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on the stratified Cox regression model.||||1.020|0.642|= 0.965639
91579054|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.324
91579055|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.031
91579056|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.076
91579057|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.013
91579058|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.553
91579059|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.132
91579060|NCT01200290|183046985|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.230
91579061|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.335
91579062|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.043
91579063|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.073
91579064|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.004
91579065|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.699
91579066|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.095
91579067|NCT01200290|183046986|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.082
91579068|NCT05014568|183047057|SUPERIORITY||Risk Ratio, log|2.6|||<|0.0001|TWO_SIDED|95.0|1.66|4.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||4.09|1.66|<0.0001
91579069|NCT05014568|183047058|SUPERIORITY||Risk Ratio, log|2.17|||<|0.0001|TWO_SIDED|95.0|1.57|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.57|<0.0001
91579070|NCT05014568|183047059|SUPERIORITY||Least squares mean difference|-6.17|STANDARD_ERROR_OF_MEAN|0.657|<|0.0001|TWO_SIDED|95.0|-7.69|-4.66|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-4.66|-7.69|<0.0001
91579071|NCT05014568|183047060|SUPERIORITY||Risk Ratio, log|3.74|||<|0.0001|TWO_SIDED|95.0|1.98|7.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||7.09|1.98|<0.0001
91579072|NCT05014568|183047061|SUPERIORITY||Risk Ratio, log|1.54||||0.0366|TWO_SIDED|95.0|1.03|2.31|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||2.31|1.03|0.0366
91579073|NCT00775463|183047128|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Cochran-Mantel-Haenszel|||A Cochran-Mantel Haenszel mean score test was used on the standardized reverse mid-ranks (overall reverse ranks divided by the number of ranks +1, or modified ridit scores; largely negative changes had ranks near 1 and largely positive changes had ranks near 0)of the residuals from an ordinary least squares regression with change in net ulcer burden at Week 20 as a linear function of Baseline PDEI or prostacyclin use (binary variable:Yes/No) and net ulcer burden at Baseline(continuous variable).||0.0|-1.0|0.20
91579074|NCT00775463|183047129|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-0.4||||0.31|TWO_SIDED|95.0|-1.4|0.4||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.40|-1.40|0.31
91579075|NCT00775463|183047130|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.12|TWO_SIDED|95.0|-21.3|2.7||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||2.7|-21.3|0.12
91579076|NCT00775463|183047131|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.04|TWO_SIDED|95.0|-18.0|0.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.0|-18.0|0.04
91579077|NCT00775463|183047132|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.47|TWO_SIDED|95.0|-4.0|2.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline in CHFS Score were tested using the Wilcoxon rank-sum test.||2.0|-4.0|0.47
91579078|NCT00775463|183047134|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.68|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||he difference between treatment groups for the change from Baseline and at Week 20 in the mRSS was tested using the Wilcoxon rank-sum test.||1.0|0.0|0.68
91579079|NCT00775463|183047135|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.54|TWO_SIDED|95.0|-3.0|2.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||2.0|-3.0|0.54
91579080|NCT00775463|183047135|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Ef|-0.6||||0.18|TWO_SIDED|95.0|-1.6|0.3||P value for Pain VAS|Wilcoxon (Mann-Whitney)|||P value for Pain VAS||0.3|-1.6|0.18
91579081|NCT00775463|183047135|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.1|TWO_SIDED|95.0|-1.0|0.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||0.0|-1.0|0.10
91579082|NCT03651622|183047302|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
91579083|NCT03651622|183047303|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
91579084|NCT03651622|183047304|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.40
91579085|NCT03651622|183047305|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
91579086|NCT03651622|183047306|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
91579087|NCT03651622|183047307|SUPERIORITY|||||||0.18|||||||ANOVA|||||||0.18
91579088|NCT03651622|183047308|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
91579089|NCT03651622|183047309|SUPERIORITY|||||||0.39|||||||ANOVA|||The proposed sample size of n=72 was sufficient to ensure 60% power to detect a moderate effect size (Cohen h=0.68) and 80% to detect a large effect size (Cohen h=0.85) at a significance level of 0.10 for comparing difference in change among the 3 diets. By design, our primary goal for this pilot work is to inform the final efficacy design of a fully powered SMART, and the pilot SMART was therefore not designed to be fully powered for all analyses.||||0.39
91579090|NCT03651622|183047310|SUPERIORITY|||||||0.75|||||||ANOVA|||||||0.75
91579091|NCT03651622|183047311|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
91579092|NCT03651622|183047312|SUPERIORITY|||||||0.96|||||||ANOVA|||||||0.96
91579093|NCT03651622|183047313|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
91579094|NCT03651622|183047314|SUPERIORITY|||||||0.58|||||||ANOVA|||||||0.58
91579095|NCT03651622|183047315|SUPERIORITY|||||||0.95|||||||ANOVA|||||||0.95
91579096|NCT03651622|183047316|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
91579097|NCT00307684|183047357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||0.2586||95.0|-2.2055|7.9774||No adjustment for multiplicity was performed. threshold for significance: 0.05 (2-sided)|ANCOVA|treatment, sex and country as factors, age and baseline sum of inattention and hyperactivity/impulsivity scores as covariate||Based on preliminary results of a controlled study in adults with MPH, the mean (SD=9) change in CAARS total score from randomization to the 4 week post-randomization endpoint was estimated as +2.5 for PR OROS MPH and +14 for placebo. slightly more conservative, a mean change of 3 in the PR OROS MPH group and a mean increase of 10 in the placebo group were expected. With a two-sided type-I error of 5% and a power of 90%, 37 eligible subjects per group were required.||7.9774|-2.2055|0.2586
91579098|NCT00307684|183047360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3942||||0.2616||95.0|-12.1928|3.4044||No adjustment for multiplicity was performed.|ANCOVA|ANCOVA on the ranks with sex, treatment and country as factors and age and baseline score as a covariate||||3.4044|-12.1928|0.2616
91579099|NCT00307684|183047361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.5458||95.0|-5.5469|10.3213|||ANCOVA|treatment and country as factors baseline score as covariate||||10.3213|-5.5469|0.5458
91579100|NCT04032613|183047370|OTHER|Paired sample t-test||||||0.2||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.20
91579101|NCT04032613|183047371|OTHER|Paired sample t-test||||||0.05||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.05
91579102|NCT04032613|183047372|OTHER|Paired sample t-test||||||0.004||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.004
91579103|NCT04032613|183047373|OTHER|Paired sample t-test||||||0.14||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.14
91579104|NCT01141647|183047441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||||TWO_SIDED|90.0|1.8|7.07||||||||7.07|1.80|
91579105|NCT01744392|183047456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.73|TWO_SIDED||||||t-test, 2 sided|||Difference between percentages. Increases in value indicate improvement in adherence.||||.73
91579106|NCT01417104|183047516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.16|||<|0.031|TWO_SIDED|95.0|0.85|9.47|||t-test, 2 sided|||||9.47|0.85|<0.031
91579107|NCT01417104|183047517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.041|TWO_SIDED|95.0|0.44|4.36|||t-test, 2 sided|||||4.36|0.44|0.041
91579108|NCT02946853|183047550|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.14|7.21|||Regression, Logistic|||||7.21|0.14|1.00
91579109|NCT02946853|183047551|SUPERIORITY||Mean Difference (Net)|-1.0||||0.974|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.974
91579110|NCT02946853|183047552|SUPERIORITY||Mean Difference (Net)|0.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Some patients did not undergo 6 month echocardiogram due to restrictions related to COVID-19.||||1.00
91579111|NCT02946853|183047553|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|84.4|||Fisher Exact|||||84.4|0.1|1.00
91579112|NCT02946853|183047554|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
91579113|NCT02946853|183047555|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.00|0.00|1.00
91579114|NCT02946853|183047556|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
91579115|NCT02946853|183047557|SUPERIORITY||Median Difference (Final Values)|23.7||||0.565|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.565
91579116|NCT02946853|183047558|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.0|0.0|1.00
91579117|NCT02369068|183047563|OTHER|||||||0.072|||||||Kruskal-Wallis|This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.||The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.||||0.072
91579118|NCT02369068|183047564|OTHER|||||||0.624|||||||Kruskal-Wallis|||The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05||||0.624
91579119|NCT02369068|183047565|OTHER|||||||0.571|||||||Kruskal-Wallis|||The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05||||0.571
91579120|NCT02369068|183047566|OTHER|||||||0.285|||||||Kruskal-Wallis|||The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05||||0.285
91579121|NCT00403767|183047580|NON_INFERIORITY_OR_EQUIVALENCE|Alternative hypothesis of non-inferiority (NI) by a NI margin of 1.46 in hazard ratio (HR) based on on-treatment data from the per protocol population. The required number of primary efficacy endpoint events was determined based on the following assumptions: NI margin of 1.46, 1-sided alpha of 0.025, power of \>95% when true HR is 1, and exponential distributions. The margin was selected based on clinical appropriateness and quantitative analysis of relevant studies in Hart et al.|Hazard Ratio (HR)|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.025 (1-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||||0.96|0.66|<0.001
91579122|NCT00403767|183047581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.015|TWO_SIDED|95.0|0.65|0.95||The p-value Is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.95|0.65|0.015
91579123|NCT00403767|183047582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.442|TWO_SIDED|95.0|0.96|1.11||The p-value is not adjusted for mulitple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternate hypothesis of superiority based on on-treatment data from the safety population.||1.11|0.96|0.442
91579124|NCT00403767|183047583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.034|TWO_SIDED|95.0|0.74|0.99||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.99|0.74|0.034
91579125|NCT00403767|183047584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.01|TWO_SIDED|95.0|0.74|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.96|0.74|0.010
91579126|NCT00403767|183047585|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.092|TWO_SIDED|95.0|0.7|1.03||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.03|0.70|0.092
91579127|NCT00403767|183047586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.003|TWO_SIDED|95.0|0.09|0.61||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.61|0.09|0.003
91579128|NCT00403767|183047587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.121|TWO_SIDED|95.0|0.63|1.06||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.06|0.63|0.121
91579129|NCT00403767|183047588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.289|TWO_SIDED|95.0|0.73|1.1||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.10|0.73|0.289
91579130|NCT00403767|183047589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.073|TWO_SIDED|95.0|0.7|1.02||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.02|0.70|0.073
91579131|NCT05319912|183047598|OTHER||Geometric Mean Ratio (%)|75.81|||||TWO_SIDED|90.0|52.23|110.02||||||Analysis was performed using analysis of variance (ANOVA).||110.02|52.23|
91579132|NCT05319912|183047598|OTHER||Geometric Mean Ratio (%)|25.2|||||TWO_SIDED|90.0|17.21|36.89||||||Analysis was performed using ANOVA.||36.89|17.21|
91579133|NCT05319912|183047599|OTHER||Geometric Mean Ratio (%)|82.65|||||TWO_SIDED|90.0|63.91|106.9||||||Analysis was performed using ANOVA.||106.90|63.91|
91579134|NCT05319912|183047599|OTHER||Geometric Mean Ratio (%)|40.49|||||TWO_SIDED|90.0|31.12|52.68||||||Analysis was performed using ANOVA.||52.68|31.12|
91579135|NCT02229851|183047612|SUPERIORITY||Treatment difference|-1.53|||=|0.009|TWO_SIDED|95.0|-2.68|-0.38|||ANCOVA||Somapacitan-Placebo|Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.||-0.38|-2.68|=0.0090
91579136|NCT01489891|183047751|NON_INFERIORITY_OR_EQUIVALENCE|Beta 0.1; Alpha 0.05|Median Difference (Final Values)|30.6|STANDARD_DEVIATION|42.1|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
91579137|NCT01276379|183047785|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.004|TWO_SIDED|95.0|1.23|3.29|||Log Rank|||||3.29|1.23|0.004
91579138|NCT01276379|183047786|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.33|3.96|||Log Rank|||||3.96|1.33|<0.0001
91579139|NCT02980731|183047808|SUPERIORITY||||||=|0.004||||||P-value is derived from a paired t-test of H0: mean difference (Week 48 - baseline) ≤ 5 versus H1: mean difference (Week 48 - baseline) \> 5|t-test, 2 sided|||||||=0.004
91579140|NCT02075476|183047841|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.048|||||||Mixed Models Analysis|||||||0.048
91579141|NCT02075476|183047842|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.001|||||||Mixed Models Analysis|||||||0.001
91579142|NCT02075476|183047843|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.011|||||||Mixed Models Analysis|||||||0.011
91579143|NCT01850446|183047844|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|8.56|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (patient diary analysis)||||<0.0001
91579144|NCT01850446|183047844|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|7.31|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (physician's examination analysis)||||<0.0001
91579145|NCT01850446|183047845|NON_INFERIORITY|Non-inferiority margin was prespecified as 1.2 degree\*day|Mean Difference (Final Values)|0.44||||0.027|ONE_SIDED|97.5|-0.23||||t-test, 1 sided|||Severity of fever was measured as area under curve (body temperature-time)|||-0.23|0.027
91579146|NCT01850446|183047846|NON_INFERIORITY|Non-inferiority magrin was prespecified as 20% of comparator duration|Mean Difference (Final Values)|0.23||||0.02|ONE_SIDED|97.5||0.63|||t-test, 1 sided|mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom||||0.63||0.02
91579147|NCT01850446|183047847|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day)|Z-value|6.95|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics||||<0.0001
91579148|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.49|||<|0.001|ONE_SIDED|97.5||1.33|||t-test, 1 sided|||Severity of influenza symptoms (day1 morning)||1.33||<0.001
91579149|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.56||||0.013|ONE_SIDED|97.5||2.59|||t-test, 1 sided|||Severity of influenza symptoms (day2 morning)||2.59||0.013
91579150|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.82||||0.084|ONE_SIDED|97.5||2.66|||t-test, 1 sided|||Severity of influenza symptoms (day3 morning)||2.66||0.084
91579151|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.62||||0.22|ONE_SIDED|97.5||2.2|||t-test, 1 sided|||Severity of influenza symptoms (day4 morning)||2.2||0.22
91579152|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.04|ONE_SIDED|97.5||1.07|||t-test, 1 sided|||Severity of influenza symptoms (day5 morning)||1.07||0.04
91579153|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.13|ONE_SIDED|97.5||0.98|||t-test, 1 sided|||Severity of influenza symptoms (day6 morning)||0.98||0.13
91579154|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25||||0.135|ONE_SIDED|97.5||0.74|||t-test, 1 sided|||severity of influenza symptoms (day1 morning)||0.74||0.135
91579155|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.64||||0.004|ONE_SIDED|97.5||2.67|||t-test, 1 sided|||Severity of influenza symptoms (day1 evening)||2.67||0.004
91579156|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.9||||0.05|ONE_SIDED|97.5||2.94|||t-test, 1 sided|||Severity of influenza symptoms (day2 evening)||2.94||0.05
91579157|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.447|ONE_SIDED|97.5||3.08|||t-test, 1 sided|||Severity of influenza symptoms (day3 evening)||3.08||0.447
91579158|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.042|ONE_SIDED|97.5||1.4|||t-test, 1 sided|||Severity of influenza symptoms (day4 evening)||1.4||0.042
91579159|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.29||||0.313|ONE_SIDED|97.5||1.53|||t-test, 1 sided|||Severity of influenza symptoms (day5 evening)||1.53||0.313
91579160|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.087|ONE_SIDED|97.5||0.77|||t-test, 1 sided|||Severity of influenza symptoms (day6 evening)||0.77||0.087
91579161|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.43|||<|0.001|ONE_SIDED|97.5||1.41|||t-test, 1 sided|||Severity of influenza symptoms (day1 physician's objective examination)||1.41||<0.001
91579162|NCT01850446|183047848|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.305|ONE_SIDED|97.5||3.11|||t-test, 1 sided|||Severity of influenza symptoms (day3 physician's objective examination)||3.11||0.305
91579163|NCT01850446|183047849|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.08||||0.02|ONE_SIDED|97.5||0.5|||t-test, 1 sided|||Fever duration||0.5||0.02
91579164|NCT01850446|183047849|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.18|||<|0.001|ONE_SIDED|97.5||0.14|||t-test, 1 sided|||Non-specific symptoms duration||0.14||<0.001
91579165|NCT01850446|183047849|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.001|ONE_SIDED|97.5||0.11|||t-test, 1 sided|||Nasal/ throat/ chest symptoms duration||0.11||<0.001
91579166|NCT01850446|183047850|NON_INFERIORITY|N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)|AUC ratio|1.04||||0.015|TWO_SIDED|95.0|0.9|1.17||bootstrap (100000 rep) confidence limits were constructed for AUC ratio|one-sample Z-test|AUC ratio was compared with N.I. margin||Severity of influenza was measured as area under curve (symptoms score-time)||1.17|0.9|0.015
91579167|NCT01850446|183047851|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.05||||0.036|ONE_SIDED|97.5||0.19|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day1)||0.19||0.036
91579168|NCT01850446|183047851|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.01||||0.009|ONE_SIDED|97.5||0.15|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day2)||0.15||0.009
91579169|NCT01850446|183047851|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.03|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day3)||0.13||<0.001
91579170|NCT01850446|183047851|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day4)||0.13||<0.001
91579171|NCT01850446|183047851|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.01|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day5)||0.01||<0.001
91579172|NCT01850446|183047852|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.0|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Percentage of Patients Requiring Antibiotics Administration||0.03||<0.001
91579173|NCT01850446|183047853|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.01||||0.014|ONE_SIDED|97.5||0.15|||Z test for proportions|||Proportion difference of Patients With Negative Results (day3)||0.15||0.014
91579174|NCT01850446|183047853|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.08||||0.037|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day5)||0.03||0.037
91579175|NCT01850446|183047853|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.03|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day7)||0.03||<0.001
91579176|NCT01850446|183047854|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.19|3.59||P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-2)||3.59|0.19|0.03
91579177|NCT01850446|183047854|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.19|TWO_SIDED|95.0|-0.64|3.12||P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-2)||3.12|-0.64|0.19
91579178|NCT01850446|183047854|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IFN-γ)||||0.012
91579179|NCT01850446|183047854|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IFN-γ)||||<0.0001
91579180|NCT01850446|183047854|SUPERIORITY|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-18)||||0.795
91579181|NCT01850446|183047854|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-18)||||0.992
91579182|NCT01850446|183047854|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92|||t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-4)||0.92|0.02|0.04
91579183|NCT01850446|183047854|SUPERIORITY||Median Difference (Final Values)|0.37||||0.08|TWO_SIDED|95.0|-0.04|0.79|||t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-4)||0.79|-0.04|0.08
91514176|NCT04079933|182900465|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-10.3||||0.4165|TWO_SIDED|95.0|-35.4|14.7|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||14.7|-35.4|0.4165
91514177|NCT04079933|182900466|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|-269.0||||0.724|TWO_SIDED|95.0|-1773.0|1235.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1235|-1773|0.7240
91514178|NCT04079933|182900466|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|50.5||||0.9508|TWO_SIDED|95.0|-1566.0|1667.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1667|-1566|0.9508
91579184|NCT01850446|183047854|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-16)||||0.062
91579185|NCT01850446|183047854|SUPERIORITY|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-16)||||0.638
91579186|NCT01850446|183047855|SUPERIORITY|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.065
91579187|NCT01850446|183047855|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.404
91579188|NCT01850446|183047855|SUPERIORITY|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-α)||||0.204
91579189|NCT01850446|183047855|SUPERIORITY|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-α)||||0.386
91579190|NCT01850446|183047855|SUPERIORITY|||||||0.592|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-γ)||||0.592
91579191|NCT01850446|183047855|SUPERIORITY|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Spontaneous IFN-γ)||||0.356
91579192|NCT01850446|183047855|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-γ)||||0.475
91514179|NCT04079933|182900467|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-19.0||||0.1524|TWO_SIDED|95.0|-45.1|7.12|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||7.12|-45.1|0.1524
91514180|NCT04079933|182900467|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-12.1||||0.4014|TWO_SIDED|95.0|-40.4|16.3|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||16.3|-40.4|0.4014
91514181|NCT04079933|182900468|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.507||||0.0241|TWO_SIDED|95.0|-0.946|-0.0674|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||-0.0674|-0.946|0.0241
91514182|NCT04079933|182900468|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.367||||0.1292|TWO_SIDED|95.0|-0.843|0.108|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||0.108|-0.843|0.1292
91514183|NCT04079933|182900469|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-10.0||||0.0333|TWO_SIDED|95.0|-19.2|-0.803|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||-0.803|-19.2|0.0333
91514184|NCT04079933|182900469|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-6.76||||0.1767|TWO_SIDED|95.0|-16.6|3.08|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||3.08|-16.6|0.1767
91579193|NCT01850446|183047855|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-γ)||||>0.99
91579194|NCT01850446|183047856|SUPERIORITY|||||||0.364|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (leukocytes)||||0.364
91579195|NCT01850446|183047856|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (leukocytes)||||0.07
91579196|NCT01850446|183047856|SUPERIORITY|||||||0.607|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day1 to day 3 (neutrophils)||||0.607
91579197|NCT01850446|183047856|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (neutrophils)||||0.028
91579198|NCT01850446|183047856|SUPERIORITY|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (lymphocytes)||||0.759
91579199|NCT01850446|183047856|SUPERIORITY|||||||0.777|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.777
91579200|NCT01850446|183047856|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (monocytes)||||0.02
91579201|NCT01850446|183047856|SUPERIORITY|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.343
91579202|NCT01850446|183047856|SUPERIORITY|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (eosinophils)||||0.575
91579203|NCT01850446|183047856|SUPERIORITY|||||||0.912|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (eosinophils)||||0.912
91579204|NCT01850446|183047856|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (basophils)||||0.242
91579205|NCT01850446|183047856|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (basophils)||||0.102
91579206|NCT01850446|183047856|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+)||||0.429
91579207|NCT01850446|183047856|SUPERIORITY|||||||0.783|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+)||||0.783
91514185|NCT04079933|182900470|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.51||||0.2961|TWO_SIDED|95.0|-4.36|1.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||1.34|-4.36|0.2961
91514186|NCT04079933|182900470|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.05||||0.5015|TWO_SIDED|95.0|-4.12|2.03|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||2.03|-4.12|0.5015
91514187|NCT04079933|182900471|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide|Mean Difference (Net)|-12.1||||0.2048|TWO_SIDED|95.0|-30.9|6.68|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide||6.68|-30.9|0.2048
91514188|NCT04079933|182900471|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide|Mean Difference (Net)|-7.32||||0.4731|TWO_SIDED|95.0|-27.4|12.8|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide||12.8|-27.4|0.4731
91514189|NCT04079933|182900472|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.86|||<|0.0001|TWO_SIDED|95.0|-5.25|-2.47|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.47|-5.25|<0.0001
91514190|NCT04079933|182900472|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.14|-2.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.34|-5.14|<0.0001
91514191|NCT04079933|182900473|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-14.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.5|-30.5|<0.0001
91514192|NCT04079933|182900473|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.3|||<|0.0001|TWO_SIDED|95.0|-30.4|-14.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.1|-30.4|<0.0001
91579208|NCT01850446|183047856|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD4+)||||0.466
91514193|NCT04079933|182900474|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.408||||0.0919|TWO_SIDED|95.0|-0.884|0.0673|||t-test, 2 sided||"Difference in LS mean change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0673|-0.884|0.0919
91514194|NCT04079933|182900474|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.405||||0.0975|TWO_SIDED|95.0|-0.886|0.0751|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0751|-0.886|0.0975
91514195|NCT04079933|182900474|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.31||||0.0643|TWO_SIDED|95.0|-17.1|0.499|||t-test, 2 sided||"Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.499|-17.1|0.0643
91514196|NCT04079933|182900474|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.84||||0.0517|TWO_SIDED|95.0|-17.7|0.0661|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.0661|-17.7|0.0517
91514197|NCT04079933|182900475|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.216||||0.216|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.2160
91514198|NCT04079933|182900475|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.0648||||0.0648|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.0648
91514199|NCT04079933|182900476|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study|Probability|0.5977||||0.5977|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study||||0.5977
91579209|NCT01850446|183047856|SUPERIORITY|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD4+)||||0.945
91579210|NCT01850446|183047856|SUPERIORITY|||||||0.335|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD8+)||||0.335
91579211|NCT01850446|183047856|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD8+)||||0.66
91579212|NCT01850446|183047856|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD16+CD56+)||||0.01
91579213|NCT01850446|183047856|SUPERIORITY|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD16+CD56+)||||0.573
91514200|NCT04079933|182900477|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL|Mean Difference (Net)|10.0||||0.4388|TWO_SIDED|95.0|-15.5|35.5|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL||35.5|-15.5|0.4388
91514201|NCT04079933|182900478|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites|Mean Difference (Net)|0.45||||0.339|TWO_SIDED|95.0|-0.48|1.38|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites||1.38|-0.48|0.3390
91514202|NCT04079933|182900479|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA|Mean Difference (Net)|-205.0||||0.4526|TWO_SIDED|95.0|-745.0|334.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA||334|-745|0.4526
91514203|NCT04079933|182900480|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin|Mean Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin||0.2|-0.2|0.9440
91514204|NCT04079933|182900481|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide|Mean Difference (Net)|0.0||||0.7484|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide||1|-1|0.7484
91514205|NCT04079933|182900482|EQUIVALENCE|Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent|Mean Difference (Net)|0.0||||0.9992|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent||0|0|0.9992
91514206|NCT04079933|182900504|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.1661||||0.1661|TWO_SIDED||||||Cochran-Mantel-Haenszel||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.1661
91514207|NCT04079933|182900504|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.2139||||0.2139|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.2139
91579214|NCT01850446|183047856|SUPERIORITY|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD16+CD56+)||||0.472
91579215|NCT01850446|183047856|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD16+CD56+)||||0.69
91579216|NCT01850446|183047856|SUPERIORITY|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD8+)||||0.727
91579217|NCT01850446|183047856|SUPERIORITY|||||||0.554|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD8+)||||0.554
91579218|NCT01850446|183047856|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD19+CD3-)||||0.837
91579219|NCT01850446|183047856|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD19+CD3-)||||0.967
91514208|NCT03207750|182900505|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.|Difference in anti-D concentration|0.0|||||TWO_SIDED|95.0|-0.8|0.79||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.||0.79|-0.80|
91514209|NCT03207750|182900505|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.|Difference in anti-T concentration|0.0|||||TWO_SIDED|95.0|-0.79|0.77||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.||0.77|-0.79|
91514210|NCT03207750|182900506|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.|Difference in anti-HB concentration|-0.65|||||TWO_SIDED|95.0|-1.9|0.16||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.||0.16|-1.90|
91514211|NCT03207750|182900507|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.|Difference in anti-polio 1 concentration|0.21|||||TWO_SIDED|95.0|-0.6|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.||1.15|-0.60|
91514212|NCT03207750|182900507|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.|Difference in anti-polio 2 concentration|-0.01|||||TWO_SIDED|95.0|-1.02|0.98||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.||0.98|-1.02|
91514213|NCT03207750|182900507|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.|Difference in anti-polio 3 concentration|0.0|||||TWO_SIDED|95.0|-0.87|0.84||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.||0.84|-0.87|
91514214|NCT03207750|182900508|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.||1.03|0.86|
91514215|NCT03207750|182900508|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.||1.08|0.92|
91514216|NCT03207750|182900508|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.||1.10|0.86|
91514217|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.||1.14|0.93|
91579220|NCT01850446|183047856|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD119+)||||0.473
91579221|NCT01850446|183047856|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD119+)||||0.736
91579222|NCT01850446|183047857|SUPERIORITY|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of neutrophils)||||0.282
91579223|NCT01850446|183047857|SUPERIORITY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of neutrophils)||||0.071
91579224|NCT01850446|183047857|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of lymphocytes)||||0.45
91514218|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.||1.11|0.91|
91514219|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.||1.09|0.90|
91514220|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.||1.17|0.94|
91514221|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.||1.12|0.92|
91514222|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.83|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.||1.12|0.83|
91514223|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.||1.08|0.91|
91514224|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.||1.14|0.93|
91514225|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.||1.13|0.89|
91514226|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.92|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.||1.14|0.92|
91514227|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.93|1.15|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.||1.15|0.93|
91579225|NCT01850446|183047857|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of lymphocytes)||||0.58
91579226|NCT01850446|183047857|SUPERIORITY|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of monocytes)||||0.017
91579227|NCT01850446|183047857|SUPERIORITY|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of monocytes)||||0.019
91579228|NCT01850446|183047857|SUPERIORITY|||||||0.424|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of eosinophils)||||0.424
91579229|NCT01850446|183047857|SUPERIORITY|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of eosinophils)||||0.666
91579230|NCT01850446|183047857|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of basophils)||||0.268
91579231|NCT01850446|183047857|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of basophils)||||0.031
91579232|NCT01850446|183047857|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+)||||0.361
91514228|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.||1.12|0.95|
91514229|NCT03207750|182900509|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.||1.10|0.87|
91514230|NCT03207750|182900510|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.|Difference in anti-PRP concentration|0.17|||||TWO_SIDED|95.0|-1.94|2.28||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.||2.28|-1.94|
91514231|NCT03207750|182900511|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.|Difference in anti-PRP concentration|-0.88|||||TWO_SIDED|95.0|-5.75|3.99||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.||3.99|-5.75|
91514232|NCT03207750|182900512|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PT antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
91514233|NCT03207750|182900512|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for FHA antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV lyophilized group||To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
91514234|NCT03207750|182900512|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PRN antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
91514235|NCT02504294|182900597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).|Difference in Percentage|-1.3975|||||TWO_SIDED|95.0|-7.6503|4.8553||||||Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).||4.8553|-7.6503|
91514236|NCT02504294|182900598|SUPERIORITY_OR_OTHER||LS Mean Difference|-1062.0|STANDARD_ERROR_OF_MEAN|803.95||0.1874|TWO_SIDED|95.0|-2643.2|519.2|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.||519.2|-2643.2|0.1874
91514237|NCT02255175|182900649|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|t=.501, df=33||||||.620
91514238|NCT02255175|182900650|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|t=.185, df=33||||||.855
91579233|NCT01850446|183047857|SUPERIORITY|||||||0.699|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+)||||0.699
91579234|NCT01850446|183047857|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD4+)||||0.418
91514239|NCT02255175|182900651|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|t=-.310, df=33||||||.758
91514240|NCT02255175|182900652|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|t=.653, df=33||||||.518
91514241|NCT02255175|182900653|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|t=.465, df=33||||||.645
91514242|NCT02255175|182900654|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|t=2.56, df=33||||||.015
91514243|NCT02255175|182900655|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|t=.705, df=33||||||.486
91514244|NCT02255175|182900656|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|t=.216, df=33||||||.831
91514245|NCT02255175|182900657|SUPERIORITY|||||||0.0002|||||||Repeated measures ANOVA|F(1,33)=17.91||||||.0002
91514246|NCT05799495|182900664|OTHER||LS Mean difference|-0.671|STANDARD_ERROR_OF_MEAN|0.3178||0.0181|TWO_SIDED|80.0|-1.08|-0.262|||Mixed Models Analysis|||||-0.262|-1.080|0.0181
91514247|NCT05799495|182900664|OTHER||LS Mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.3562||0.0127|TWO_SIDED|80.0|-1.26|-0.344|||Mixed Models Analysis|||||-0.344|-1.260|0.0127
91579235|NCT01850446|183047857|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD4+)||||>0.99
91514248|NCT05799495|182900664|OTHER||LS Mean difference|-1.167|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|80.0|-1.506|-0.827|||Mixed Models Analysis|||||-0.827|-1.506|<.0001
91514249|NCT05799495|182900665|OTHER||LS Mean difference|-0.608|STANDARD_ERROR_OF_MEAN|0.3402||0.0378|TWO_SIDED|80.0|-1.046|-0.17|||Mixed Models Analysis|||Day 3||-0.170|-1.046|0.0378
91514250|NCT05799495|182900665|OTHER||LS Mean difference|-1.304|STANDARD_ERROR_OF_MEAN|0.3718||0.0003|TWO_SIDED|80.0|-1.782|-0.826|||Mixed Models Analysis|||Day 3||-0.826|-1.782|0.0003
91514251|NCT05799495|182900665|OTHER||LS Mean difference|-1.148|STANDARD_ERROR_OF_MEAN|0.2803|<|0.0001|TWO_SIDED|80.0|-1.509|-0.788|||Mixed Models Analysis|||Day 3||-0.788|-1.509|<.0001
91514252|NCT05799495|182900665|OTHER||LS Mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.2732||0.5931|TWO_SIDED|80.0|-0.287|0.416|||Mixed Models Analysis|||Day 10||0.416|-0.287|0.5931
91514253|NCT05799495|182900665|OTHER||LS Mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.2914||0.508|TWO_SIDED|80.0|-0.369|0.381|||Mixed Models Analysis|||Day 10||0.381|-0.369|0.5080
91514254|NCT05799495|182900665|OTHER||LS Mean difference|-0.214|STANDARD_ERROR_OF_MEAN|0.223||0.1692|TWO_SIDED|80.0|-0.501|0.073|||Mixed Models Analysis|||Day 10||0.073|-0.501|0.1692
91514255|NCT05799495|182900665|OTHER||LS Mean difference|-0.239|STANDARD_ERROR_OF_MEAN|0.2004||0.1172|TWO_SIDED|80.0|-0.497|0.019|||Mixed Models Analysis|||Day 14||0.019|-0.497|0.1172
91579236|NCT01850446|183047857|SUPERIORITY|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD8+)||||0.172
91579237|NCT01850446|183047857|SUPERIORITY|||||||0.904|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD8+)||||0.904
91579238|NCT01850446|183047857|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)||||0.148
91579239|NCT01850446|183047857|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)||||0.821
91579240|NCT01850446|183047857|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)||||0.31
91579241|NCT01850446|183047857|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)||||>0.99
91579242|NCT01850446|183047857|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD8+)||||0.43
91579243|NCT01850446|183047857|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD8+)||||0.821
91579244|NCT01850446|183047857|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD19+CD3-)||||0.943
91579245|NCT01850446|183047857|SUPERIORITY|||||||0.841|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD19+CD3-)||||0.841
91514256|NCT05799495|182900665|OTHER||LS Mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.2178||0.3979|TWO_SIDED|80.0|-0.337|0.224|||Mixed Models Analysis|||Day 14||0.224|-0.337|0.3979
91514257|NCT05799495|182900665|OTHER||LS Mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.1655||0.0109|TWO_SIDED|80.0|-0.595|-0.17|||Mixed Models Analysis|||Day 14||-0.170|-0.595|0.0109
91514258|NCT04177108|182900685|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0098||95.0|0.28|0.85|||Log Rank|||||0.85|0.28|0.0098
91514259|NCT04177108|182900685|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.2396||95.0|0.42|1.25|||Log Rank|||||1.25|0.42|0.2396
91514260|NCT04177108|182900685|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9809||95.0|0.63|1.58|||Log Rank|||||1.58|0.63|0.9809
91514261|NCT04177108|182900686|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6805||95.0|0.55|2.51|||Log Rank|||||2.51|0.55|0.6805
91514262|NCT04177108|182900686|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.6314||95.0|0.55|2.64|||Log Rank|||||2.64|0.55|0.6314
91514263|NCT04177108|182900686|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9164||95.0|0.52|2.06|||Log Rank|||||2.06|0.52|0.9164
91514264|NCT04737538|182900697|OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-13.3|-8.8|||Non-parametric method (Van Elteren test)|||||-8.8|-13.3|<0.0001
91514265|NCT04737538|182900698|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.01||0.4488|TWO_SIDED|95.0|-1.6|2.4|||Non-parametric method (Van Elteren test)|||||2.4|-1.6|0.4488
91514266|NCT04737538|182900699|OTHER||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-13.8|-9.1|||Non-parametric method (Van Elteren test)|||||-9.1|-13.8|<0.0001
91514267|NCT01652716|182900700|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1349||0.0072|TWO_SIDED|95.0|-0.63|-0.1|||Mixed model for repeated measure (MMRM)|Based on a repeated measures mixed model including fixed categorical effects of treatment||||-0.10|-0.63|0.0072
91514268|NCT01652716|182900701|SUPERIORITY_OR_OTHER|||||||0.2247|||||||Cochran-Mantel-Haenszel|||||||0.2247
91514269|NCT01652716|182900702|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|5.841||0.1656|TWO_SIDED|95.0|-21.7|1.3||Adjusted|Cochran-Mantel-Haenszel|||||1.3|-21.7|0.1656
91514270|NCT01652716|182900703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4497||0.3744|TWO_SIDED|95.0|-0.48|1.28|||Cochran-Mantel-Haenszel|||||1.28|-0.48|0.3744
91514271|NCT01652716|182900704|SUPERIORITY_OR_OTHER||LS Mean Difference|26.74|STANDARD_ERROR_OF_MEAN|15.8957||0.0985|TWO_SIDED|95.0|-5.16|58.64|||Cochran-Mantel-Haenszel|||||58.64|-5.16|0.0985
91514272|NCT01422070|182900708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||<|0.05|TWO_SIDED|95.0|0.45|0.88|||generalized estimating equation|Generalized estimating equation adjusts the confidence interval for the correlation of outcomes within-centre.|The fully adjusted multivariable logistic regression analysis showed an OR of 0.63 in favour of the presence of an intermediate care unit in the hospital|The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospital||0.88|0.45|<0.05
91514273|NCT04122443|182900709|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.3|1.9||||||||1.9|0.3|
91514274|NCT04122443|182900710|SUPERIORITY||Mean Difference (Final Values)|13.0|||||TWO_SIDED|95.0|-3.0|29.0||||||||29|-3|
91514275|NCT04122443|182900711|SUPERIORITY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-5.0|23.0||||||||23|-5|
91514276|NCT04122443|182900712|SUPERIORITY||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-10.0|21.0||||||||21|-10|
91514277|NCT05204134|182900716|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
91514278|NCT05204134|182900717|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
91514279|NCT05204134|182900718|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
91514280|NCT05204134|182900719|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91514281|NCT05204134|182900720|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
91514282|NCT05204134|182900721|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
91514283|NCT05204134|182900722|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514284|NCT05204134|182900723|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514285|NCT05204134|182900724|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514286|NCT05204134|182900725|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.||||<0.001
91514287|NCT05204134|182900726|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514288|NCT05204134|182900727|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514289|NCT05204134|182900728|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514290|NCT05204134|182900729|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91579246|NCT00591721|183047858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.53|STANDARD_DEVIATION|6.47|<|0.05|TWO_SIDED|95.0|-15.47|10.41|||t-test, 2 sided|Each baseline subscale score was subtracted from 7 week subscale score; t-tests assessed mean individual differences between groups.||Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.||10.41|-15.47|<0.05
91514291|NCT05204134|182900730|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514292|NCT05204134|182900731|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514293|NCT05204134|182900732|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514294|NCT05204134|182900733|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514295|NCT05204134|182900734|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514296|NCT05204134|182900735|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
91514297|NCT05204134|182900736|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
91514298|NCT05204134|182900737|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
91514299|NCT01312467|182900746|SUPERIORITY_OR_OTHER||||||>|0.773|TWO_SIDED||||||A paired t-test|||||||> 0.773
91514300|NCT01968434|182900799|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The sample size was calculated to detect a 0.75 point difference between any two treatment groups with a 90% power and p\<0.05. Such sample size was 60 subject which was elevated ot 75 subjects per group to account for drop outs. For comparison of cough evaluation before and after treatment a paired Student t test was used.||||<0.01
91514301|NCT01968434|182900800|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
91514302|NCT01968434|182900801|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
91514303|NCT02199691|182900802|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|9.2|||||TWO_SIDED|95.0|3.4|15.0||||||Serogroup A||15|3.4|
91514304|NCT02199691|182900802|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|24.6|||||TWO_SIDED|95.0|20.3|29.0||||||Serogroup C||29|20.3|
91514305|NCT02199691|182900802|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|16.2|||||TWO_SIDED|95.0|12.3|20.2||||||||20.2|12.3|
91514306|NCT02199691|182900802|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|19.6|||||TWO_SIDED|95.0|14.2|24.8||||||Serogroup W||24.8|14.2|
91514307|NCT02199691|182900803|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|5.0|||||TWO_SIDED|95.0|-0.8|10.5||||||Serogroup A||10.5|-0.8|
91514308|NCT02199691|182900803|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.4||||||Serogroup C||2.4|-2.5|
91514309|NCT02199691|182900803|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.3|1.2||||||Serogroup Y||1.2|-4.3|
91514310|NCT02199691|182900803|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-7.3|2.6||||||Serogroup W||2.6|-7.3|
91514311|NCT02199691|182900804|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.845|||||TWO_SIDED|95.0|0.722|0.99||||||PT: Geometric Mean Ratio||0.99|0.722|
91514312|NCT02199691|182900804|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.746|||||TWO_SIDED|95.0|0.661|0.842||||||FHA: Geometric Mean Ratio||0.842|0.661|
91514313|NCT02199691|182900804|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.753|||||TWO_SIDED|95.0|0.627|0.903||||||PRN: Geometric Mean Ratio||0.903|0.627|
91514314|NCT02199691|182900804|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.679|||||TWO_SIDED|95.0|0.525|0.878||||||FIM: Geometric Mean Ratio||0.878|0.525|
91514315|NCT02199691|182900805|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|-1.1|||||TWO_SIDED|95.0|-3.3|1.3||||||Serogroup Diphtheria||1.3|-3.3|
91514316|NCT02199691|182900805|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.1|||||TWO_SIDED|95.0|-1.2|1.9||||||Serogroup Tetanus||1.9|-1.2|
91514317|NCT02199691|182900806|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-1.8|6.3||||||HPV Type 6||6.3|-1.8|
91514318|NCT02199691|182900806|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.8|||||TWO_SIDED|95.0|-1.3|3.9||||||HPV Type 11||3.9|-1.3|
91514319|NCT02199691|182900806|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 16||3.6|-1.9|
91514320|NCT02199691|182900806|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 18||3.6|-1.9|
91514321|NCT00612313|182900824|SUPERIORITY_OR_OTHER||Difference in percentages|9.7||||0.02|TWO_SIDED|||||The estimated rate of time spent well was evaluated using a Poisson regression with adjustment for CDRS-R score at the end of the acute phase, age group, and gender.|Regression, Poisson||Differencein percentages represents estimated percentage for medication management + CBT Arm minus estimated percentage for medication management only Arm.|||||.02
91514322|NCT02062502|182900853|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-3.2|3.2|||Miettinen and Nurminen|||||3.2|-3.2|<0.001
91514323|NCT02062502|182900854|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.|Risk Difference (RD)|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||t-test, 2 sided|||||1.06|0.85|<0.001
91514324|NCT02062502|182900854|SUPERIORITY_OR_OTHER||Antibody Response Rate|97.2|||<|0.001|TWO_SIDED|95.0|94.4|98.9|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||98.9|94.4|<0.001
91579247|NCT03527550|183047875|SUPERIORITY|||||||0.95|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in negative urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in negative urgency as a function of condition (interaction of condition X time; reported below).||||0.95
91579248|NCT03527550|183047876|SUPERIORITY|||||||0.64|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in positive urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in positive urgency as a function of condition (interaction of condition X time; reported below).||||0.64
91514325|NCT00566228|182900895|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.08|||Log Rank|||||2.08|0.62|0.690
91514326|NCT00566228|182900898|SUPERIORITY|||||||0.679|||||||Log Rank|||||||0.679
91514327|NCT03320070|182900905|SUPERIORITY|||||||0.5076|||||||Chi-squared|||||||0.5076
91514328|NCT03320070|182900907|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
91514329|NCT03320070|182900909|SUPERIORITY|||||||0.0848|||||||Chi-squared|||||||0.0848
91514330|NCT03320070|182900911|SUPERIORITY|||||||0.2005|||||||Chi-squared|||||||0.2005
91514331|NCT03320070|182900913|SUPERIORITY|||||||0.9416|||||||Chi-squared|||||||0.9416
91514332|NCT03320070|182900915|SUPERIORITY|||||||0.1853|||||||Chi-squared|||||||0.1853
91514333|NCT03586648|182900917|SUPERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than 32 points.|Least-square Mean|39.3|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|32.7|45.9|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||Data only from the first period will be used if period effect is significant.||45.9|32.7|
91514334|NCT03586648|182900918|NON_INFERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than -5 points.|Least-square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-19.7|-3.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.||-3.3|-19.7|
91514335|NCT02041195|182900920|OTHER||Least Squares (LS) Mean Difference|-4.26||||0.004|TWO_SIDED|90.0|-6.81|-1.72||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.72|-6.81|0.004
91514336|NCT02041195|182900920|OTHER||LS Mean difference|-3.63||||0.012|TWO_SIDED|90.0|-6.23|-1.03|||Longitudinal mixed analysis of variance|One-sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.03|-6.23|0.012
91514337|NCT02041195|182900922|OTHER||LS Mean Difference|-3.57|||<|0.001|TWO_SIDED|90.0|-5.24|-1.89||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.89|-5.24|<0.001
91514338|NCT02041195|182900924|OTHER||LS Mean Difference|-2.22||||0.002|TWO_SIDED|90.0|-3.44|-1.0|||Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.00|-3.44|0.002
91514339|NCT00414700|182900934|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion||Test for superiority||||0.003
91514340|NCT00414700|182900935|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion.||Test for superiority||||0.010
91514341|NCT00414700|182900936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -9 % points|Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-3.28|6.9|||ANCOVA|Adjusted for baseline Overall KOOS score, age, associated lesion(s) and location of lesion.||||6.90|-3.28|
91514342|NCT01138124|182901023|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.04|||<|0.0001|TWO_SIDED|95.0|1.51|2.75|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.75|1.51|<0.0001
91514343|NCT01138124|182901023|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.82||||0.0001|TWO_SIDED|95.0|1.34|2.46|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.46|1.34|0.0001
91514344|NCT01138124|182901023|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.52||||0.0627|TWO_SIDED|95.0|0.98|2.36|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.36|0.98|0.0627
91514345|NCT01138124|182901023|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.2183|TWO_SIDED|95.0|0.85|2.08|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.85|0.2183
91514346|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.82|||<|0.0001|TWO_SIDED|95.0|1.86|4.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.28|1.86|<0.0001
91514347|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.53|||<|0.0001|TWO_SIDED|95.0|1.66|3.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy"|||3.85|1.66|<0.0001
91514348|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.001|TWO_SIDED|95.0|1.51|5.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.03|1.51|0.001
91514349|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.44||||0.0042|TWO_SIDED|95.0|1.32|4.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.49|1.32|0.0042
91514350|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.8||||0.0645|TWO_SIDED|95.0|0.97|3.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.36|0.97|0.0645
91514351|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1232|TWO_SIDED|95.0|0.87|3.11|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.11|0.87|0.1232
91514352|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.55||||0.316|TWO_SIDED|95.0|0.17|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.78|0.17|0.3160
91514353|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.48||||0.2234|TWO_SIDED|95.0|0.15|1.57|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||1.57|0.15|0.2234
91514354|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3071|TWO_SIDED|95.0|0.76|2.42|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.42|0.76|0.3071
91514355|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.17||||0.6062|TWO_SIDED|95.0|0.65|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.11|0.65|0.6062
91514356|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.31||||0.5205|TWO_SIDED|95.0|0.58|2.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.97|0.58|0.5205
91514357|NCT01138124|182901024|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.11||||0.8042|TWO_SIDED|95.0|0.48|2.57|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.57|0.48|0.8042
91514358|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.86|2.04|<0.0001
91514359|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.88|||<|0.0001|TWO_SIDED|95.0|1.85|4.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.46|1.85|<0.0001
91514360|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.0015|TWO_SIDED|95.0|1.47|5.13|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.13|1.47|0.0015
91514361|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.45||||0.0053|TWO_SIDED|95.0|1.31|4.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.62|1.31|0.0053
91514362|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.68||||0.0777|TWO_SIDED|95.0|0.94|2.99|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.99|0.94|0.0777
91514363|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.5||||0.1762|TWO_SIDED|95.0|0.83|2.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.69|0.83|0.1762
91514364|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.82||||0.699|TWO_SIDED|95.0|0.29|2.28|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.28|0.29|0.6990
91514365|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.72||||0.5274|TWO_SIDED|95.0|0.26|2.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.01|0.26|0.5274
91514366|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3245|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3245
91514367|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6388|TWO_SIDED|95.0|0.64|2.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.07|0.64|0.6388
91514368|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.11||||0.796|TWO_SIDED|95.0|0.49|2.51|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.51|0.49|0.796
91514369|NCT01138124|182901025|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.94||||0.8772|TWO_SIDED|95.0|0.41|2.15|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.15|0.41|0.8772
91514370|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.88|4.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.47|1.88|<0.0001
91514371|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.65|||<|0.0001|TWO_SIDED|95.0|1.71|4.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.11|1.71|<0.0001
91514372|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.19||||0.0212|TWO_SIDED|95.0|1.12|4.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||4.25|1.12|0.0212
91514373|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.95||||0.0522|TWO_SIDED|95.0|0.99|3.81|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.81|0.99|0.0522
91514374|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.87||||0.0337|TWO_SIDED|95.0|1.05|3.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.32|1.05|0.0337
91514375|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.64||||0.0947|TWO_SIDED|95.0|0.92|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.95|0.92|0.0947
91514376|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.42||||0.3928|TWO_SIDED|95.0|0.64|3.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.16|0.64|0.3928
91514377|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.21||||0.6502|TWO_SIDED|95.0|0.54|2.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.72|0.54|0.6502
91514378|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3275|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3275
91514379|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6365|TWO_SIDED|95.0|0.64|2.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.64|0.6365
91514380|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.01||||0.9858|TWO_SIDED|95.0|0.42|2.41|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.42|0.9858
91514381|NCT01138124|182901026|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.87||||0.7671|TWO_SIDED|95.0|0.36|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.12|0.36|0.7671
91514382|NCT01138124|182901027|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.79||||0.0031|TWO_SIDED|95.0|1.22|2.63|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.63|1.22|0.0031
91514383|NCT01138124|182901027|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.68||||0.0095|TWO_SIDED|95.0|1.13|2.49|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.49|1.13|0.0095
91514384|NCT01138124|182901027|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.65||||0.097|TWO_SIDED|95.0|0.91|2.99|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.99|0.91|0.0970
91514385|NCT01138124|182901027|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.1123|TWO_SIDED|95.0|0.89|2.97|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.97|0.89|0.1123
91514386|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.53||||0.0012|TWO_SIDED|95.0|1.44|4.44|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)"|||4.44|1.44|0.0012
91514387|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0034|TWO_SIDED|95.0|1.32|4.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.14|1.32|0.0034
91514388|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.18||||0.0856|TWO_SIDED|95.0|0.9|5.32|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.32|0.9|0.0856
91514389|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.0996|TWO_SIDED|95.0|0.87|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|0.87|0.0996
91514390|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0563|TWO_SIDED|95.0|0.98|3.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.63|0.98|0.0563
91514391|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0896|TWO_SIDED|95.0|0.92|3.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.43|0.92|0.0896
91514392|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.4||||0.5308|TWO_SIDED|95.0|0.49|4.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.01|0.49|0.5308
91514393|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.39||||0.5458|TWO_SIDED|95.0|0.48|4.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.02|0.48|0.5458
91514394|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.87||||0.7744|TWO_SIDED|95.0|0.35|2.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.19|0.35|0.7744
91514395|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.83||||0.6999|TWO_SIDED|95.0|0.33|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.11|0.33|0.6999
91514396|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.32||||0.6528|TWO_SIDED|95.0|0.39|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.47|0.39|0.6528
91514397|NCT01138124|182901028|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.3||||0.6722|TWO_SIDED|95.0|0.38|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.47|0.38|0.6722
91514398|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.24|||<|0.0001|TWO_SIDED|95.0|1.79|5.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||5.85|1.79|<0.0001
91514399|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||0.0005|TWO_SIDED|95.0|1.59|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|1.59|0.0005
91514400|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.54||||0.042|TWO_SIDED|95.0|1.03|6.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.25|1.03|0.042
91579249|NCT03527550|183047877|SUPERIORITY|||||||0.91||||||Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).|ANOVA|||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in stop-signal reaction time at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in stop-signal reaction time as a function of condition (interaction of condition X time; reported below).||||0.91
91514401|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.4||||0.0603|TWO_SIDED|95.0|0.96|5.98|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.98|0.96|0.0603
91514402|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.65|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.65|0.69|0.3762
91514403|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.4073|TWO_SIDED|95.0|0.68|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.63|0.68|0.4073
91514404|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.95||||0.9294|TWO_SIDED|95.0|0.29|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.12|0.29|0.9294
91514405|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.99||||0.9875|TWO_SIDED|95.0|0.3|3.29|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.29|0.3|0.9875
91514406|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.19||||0.66|TWO_SIDED|95.0|0.54|2.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.54|0.66
91514407|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||0.811|TWO_SIDED|95.0|0.5|2.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.45|0.5|0.8110
91514408|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.7||||0.3336|TWO_SIDED|95.0|0.58|4.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.96|0.58|0.3336
91514409|NCT01138124|182901029|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.3782|TWO_SIDED|95.0|0.55|4.84|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.84|0.55|0.3782
91514410|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0841|TWO_SIDED|95.0|0.92|3.88|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.88|0.92|0.0841
91514411|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.75||||0.1313|TWO_SIDED|95.0|0.85|3.63|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.63|0.85|0.1313
91514412|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.03||||0.1488|TWO_SIDED|95.0|0.78|5.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.34|0.78|0.1488
91514413|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.05||||0.1495|TWO_SIDED|95.0|0.77|5.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.46|0.77|0.1495
91514414|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.44||||0.0013|TWO_SIDED|95.0|1.42|4.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.22|1.42|0.0013
91514415|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0026|TWO_SIDED|95.0|1.35|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.07|1.35|0.0026
91514416|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.78||||0.2421|TWO_SIDED|95.0|0.68|4.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.69|0.68|0.2421
91514417|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.7||||0.2899|TWO_SIDED|95.0|0.64|4.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.53|0.64|0.2899
91514418|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.99||||0.9723|TWO_SIDED|95.0|0.42|2.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.29|0.42|0.9723
91514419|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.91||||0.8206|TWO_SIDED|95.0|0.39|2.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.13|0.39|0.8206
91514420|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.8135|TWO_SIDED|95.0|0.35|3.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.82|0.35|0.8135
91514421|NCT01138124|182901030|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.8173|TWO_SIDED|95.0|0.34|3.86|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.86|0.34|0.8173
91514422|NCT00987467|182901031|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
91514423|NCT00262834|182901043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.42
91514424|NCT00262834|182901044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.50
91514425|NCT00262834|182901045|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91514426|NCT00377819|182901063|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.35%|Mean Difference (Final Values)|0.85|||<|0.0001||95.0|0.44|1.25|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.25|0.44|<0.0001
91514427|NCT00377819|182901064|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.22%|Mean Difference (Final Values)|1.18|||<|0.0001||95.0|0.63|1.73|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.73|0.63|<0.0001
91514428|NCT00377819|182901065|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Van Elteren Stratified Rank Test|||||||<0.0001
91514429|NCT01054820|182901077|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.||||<0.0001
91514430|NCT01054820|182901078|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|McNemar|||||||<0.0001
91514431|NCT01054820|182901079|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
91514432|NCT01054820|182901080|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
91514433|NCT01054820|182901081|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
91514434|NCT01054820|182901082|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
91514435|NCT01054820|182901085|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
91514436|NCT02239679|182901139|SUPERIORITY|||||||0.0166|||||||ANCOVA|||||||0.0166
91514437|NCT02239679|182901145|SUPERIORITY|||||||0.0102||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0102
91514438|NCT02239679|182901145|SUPERIORITY|||||||0.0089||||||no adjustment for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0089
91514439|NCT02239679|182901146|SUPERIORITY|||||||0.0004||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0004
91514440|NCT02239679|182901146|SUPERIORITY||||||<|0.0001||||||no adjustment for multiple comparison|Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
91514441|NCT00760929|182901213|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4301||90.0|0.58|1.21|||Wald Test|||||1.21|0.58|0.4301
91514442|NCT00760929|182901213|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0342||90.0|0.42|0.9|||Wald Test|||||0.90|0.42|0.0342
91514443|NCT01614210|182901240|OTHER||percentage decrease in Ki67 after 7 days|||||0.0001|||||||t-test, 1 sided|||||||0.0001
91514444|NCT04321460|182901261|SUPERIORITY||Odds Ratio (OR)|4.564||||0.007|TWO_SIDED|95.0|1.66|16.039|||Wilcoxon (Mann-Whitney)|||||16.039|1.66|0.007
91514445|NCT04321460|182901262|SUPERIORITY||Odds Ratio (OR)|4.716||||0.002|TWO_SIDED|95.0|1.898|14.268|||Wilcoxon (Mann-Whitney)|||||14.268|1.898|0.002
91514446|NCT04495712|182901275|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
91514447|NCT04495712|182901276|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
91514448|NCT04495712|182901277|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
91514449|NCT03669081|182901281|OTHER|The null hypothesis for the test was no difference between groups.||||||0.006||||||The significance level for this test was 0.05.|Wilcoxon (Mann-Whitney)|We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.||||||0.006
91514450|NCT03669081|182901282|OTHER|The null hypothesis was no difference between groups.||||||0.029|||||||Exact Wilcoxon rank sum test|||||||0.029
91514451|NCT03669081|182901283|NON_INFERIORITY|We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.|||||<|0.0001||||||This p-value was compared to a significance threshold of 0.025.|Wilcoxon (Mann-Whitney)|||The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.||||<0.0001
91514452|NCT03669081|182901284|OTHER|The null hypothesis was no difference between groups.||||||0.002|||||||t-test, 2 sided|||||||0.002
91514453|NCT03669081|182901285|OTHER|The null hypothesis was no difference between groups.|||||>|0.99|||||||Fisher Exact|||||||>0.99
91514454|NCT00706121|182901287|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96||||0.96|TWO_SIDED|95.0|0.9|1.02|||Log binomial regression|||||1.02|0.9|0.96
91514455|NCT00706121|182901288|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.92||||0.32|TWO_SIDED|95.0|0.78|1.08|||Log binomial regression|||||1.08|0.78|0.32
91514456|NCT00706121|182901290|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.91||||0.24|TWO_SIDED|95.0|0.77|1.07|||Log binomial regression|||||1.07|0.77|0.24
91514457|NCT00706121|182901291|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.38|TWO_SIDED|95.0|0.96|1.1|||Log binomial regression|||||1.10|0.96|0.38
91514458|NCT01308749|182901296|OTHER||||||||||||||||||No analyses were completed, this is descriptive only and is an absolute value (number of participants).|||
91514459|NCT01308749|182901300|EQUIVALENCE|Within group test of difference using t-scores adjusted by baseline score, no correction for multiple comparisons, nonparametric model||||||0.023|||||||t-test, 2 sided|||||||0.023
91514460|NCT01308749|182901302|EQUIVALENCE|t-test between groups||||||0.23|||||||t-test, 2 sided|no adjustment for multiple comparison. non parametric||||||0.23
91514461|NCT02223390|182901313|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.||||||0.08||||||A priori threshold for statistical significance was p\<.05. The p-value presented corresponds to the time by condition interaction parameter.|Mixed Models Analysis|To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.||Statistical analyses reported below is for PCL - Total at 3 months.||||0.08
91514462|NCT02223390|182901314|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.||||||0.05||||||A priori threshold was defined as p\<0.05.|Chi-squared|||||||0.05
91514463|NCT01666002|182901337|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
91514464|NCT01666002|182901338|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91514465|NCT02585895|182901355|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|74.2|||<|0.0001|TWO_SIDED|95.0|44.6|86.8|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by screening LDL-C level|Treatment difference used apheresis as the reference.|||86.8|44.6|< 0.0001
91514466|NCT02585895|182901356|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-52.74|STANDARD_ERROR_OF_MEAN|5.64|<|0.0001|TWO_SIDED|95.0|-64.18|-41.3|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-41.30|-64.18|< 0.0001
91514467|NCT02585895|182901357|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-46.37|STANDARD_ERROR_OF_MEAN|4.67|<|0.0001|TWO_SIDED|95.0|-55.85|-36.9|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-36.90|-55.85|< 0.0001
91514468|NCT02585895|182901358|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-35.8|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-43.39|-28.21|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.||||-28.21|-43.39|< 0.0001
91514469|NCT01169467|182901363|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||t-test, 2 sided|||||||0.395
91514470|NCT03108924|182901368|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.53|1.13||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.13|0.53|
91514471|NCT03108924|182901371|OTHER||GMR|2.98|||||TWO_SIDED|90.0|2.01|4.41||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||4.41|2.01|
91514472|NCT03108924|182901371|OTHER||GMR|4.43|||||TWO_SIDED|95.0|2.82|6.96||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.96|2.82|
91514473|NCT03108924|182901371|OTHER||GMR|4.74|||||TWO_SIDED|90.0|2.95|7.59||||Categorical Analysis|GMR = GM for ESRD HD / GM for Healthy Controls|||7.59|2.95|
91514474|NCT03108924|182901373|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.54|1.08||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.08|0.54|
91514475|NCT03108924|182901376|OTHER||GMR|3.23|||||TWO_SIDED|90.0|2.01|5.2||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||5.20|2.01|
91514476|NCT03108924|182901376|OTHER||GMR|4.08|||||TWO_SIDED|90.0|2.49|6.7||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.70|2.49|
91514477|NCT03108924|182901376|OTHER||GMR|4.43|||||TWO_SIDED|90.0|2.65|7.39||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||7.39|2.65|
91514478|NCT03108924|182901378|OTHER||GMR|0.73|||||TWO_SIDED|90.0|0.52|1.03||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.03|0.52|
91514479|NCT03108924|182901381|OTHER||GMR|2.09|||||TWO_SIDED|90.0|1.22|3.56||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||3.56|1.22|
91514480|NCT03108924|182901381|OTHER||GMR|1.89|||||TWO_SIDED|95.0|1.1|3.25||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||3.25|1.10|
91514481|NCT03108924|182901381|OTHER||GMR|1.9|||||TWO_SIDED|90.0|1.13|3.19||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||3.19|1.13|
91514482|NCT03108924|182901383|OTHER||GMR|1.3|||||TWO_SIDED|90.0|0.88|1.9||||Categorical Analysis|GMR = GM for ESRD / GM for ESRD Non-HD|||1.90|0.88|
91514483|NCT03108924|182901386|OTHER||GMR|0.34|||||TWO_SIDED|95.0|0.23|0.5||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.50|0.23|
91514484|NCT03108924|182901386|OTHER||GMR|0.23|||||TWO_SIDED|95.0|0.14|0.35||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.35|0.14|
91514485|NCT03108924|182901386|OTHER||GMR|0.21|||||TWO_SIDED|95.0|0.13|0.34||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||0.34|0.13|
91514486|NCT03108924|182901388|OTHER||GMR|0.31|||||TWO_SIDED|90.0|0.25|0.39||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.39|0.25|
91514487|NCT03108924|182901388|OTHER||GMR|0.1|||||TWO_SIDED|90.0|0.07|0.16||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.16|0.07|
91514488|NCT05003791|182901427|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
91514489|NCT05003791|182901428|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
91514490|NCT05003791|182901429|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
91514491|NCT02207829|182901430|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.|Mean Difference (Final Values)|0.059|||<|0.001|TWO_SIDED|95.0|0.029|0.088|||Mixed Models Analysis|||||0.088|0.029|<0.001
91514492|NCT03285477|182901435|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
91514493|NCT03285477|182901436|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
91514494|NCT00560833|182901455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-2.3|-0.4||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.4|-2.3|<0.01
91514495|NCT00560833|182901455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.01|TWO_SIDED|95.0|-3.1|-1.2||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.2|-3.1|<0.01
91514496|NCT00560833|182901455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
91514497|NCT00560833|182901455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
91514498|NCT00560833|182901457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.06|TWO_SIDED|95.0|-2.0|0.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.0|-2.0|0.06
91514499|NCT00560833|182901457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.01|TWO_SIDED|95.0|-3.0|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-3.0|<0.01
91514500|NCT00560833|182901457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-2.9|<0.01
91514501|NCT00560833|182901457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.01|TWO_SIDED|95.0|-2.6|-0.5||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.5|-2.6|<0.01
91514502|NCT00560833|182901458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.62|TWO_SIDED|95.0|-0.09|0.03||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.03|-0.09|0.62
91514503|NCT00560833|182901458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
91514504|NCT00560833|182901458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.01|TWO_SIDED|95.0|-0.13|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.13|0.01
91514505|NCT00560833|182901458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
91514506|NCT00560833|182901459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-0.06|0.07||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.07|-0.06|1.0
91514507|NCT00560833|182901459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.72|TWO_SIDED|95.0|-0.09|0.04||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.04|-0.09|0.72
91514508|NCT00560833|182901459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.13|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.13
91514509|NCT00560833|182901459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.15|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.15
91514510|NCT03283670|182901460|SUPERIORITY||Mean Difference (Net)|-0.75||||0.55|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 25% nitrous oxide||||0.55
91514511|NCT03283670|182901460|SUPERIORITY||Mean Difference (Net)|-1.4||||0.47|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21, 25% nitrous oxide vs placebo at 24 hours||||0.47
91514512|NCT03283670|182901460|SUPERIORITY||Median Difference (Net)|-0.87||||0.49|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 50% nitrous oxide||||0.49
91514513|NCT03283670|182901460|SUPERIORITY||Mean Difference (Net)|-1.9||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, placebo vs 50% nitrous oxide||||0.34
91514514|NCT03283670|182901460|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.94|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 2 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.94
91514515|NCT03283670|182901460|SUPERIORITY||Mean Difference (Net)|-0.5||||0.8|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.80
91514516|NCT01085318|182901461|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|864.1||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
91514517|NCT01085318|182901462|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|644.99|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91514518|NCT00791765|182901542|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||van Elteren's test|Stratified by baseline body mass index group||||||<0.0001
91514519|NCT00791765|182901543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline body mass index group||||||<0.0001
91514520|NCT00791765|182901544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided pairwise van Elteren's test|Stratified by baseline body mass index group||Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)||||<0.0001
91514521|NCT00791765|182901545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided test with modified ridit scores stratified by baseline body mass index group||||||<0.0001
91514522|NCT04295564|182901546|SUPERIORITY||Mean Difference (Final Values)|82.1|||<|0.05|TWO_SIDED|95.0|8.3|155.9||This is a calculate p value|Mixed Models Analysis|adjusted for the correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing||||155.9|8.3|<0.05
91514523|NCT04295564|182901547|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.02|TWO_SIDED|95.0|0.1|1.1||This is a calculated p value|Mixed Models Analysis|Adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient test.||||1.1|0.1|<0.02
91514524|NCT04295564|182901548|SUPERIORITY||Mean Difference (Final Values)|62.7|||<|0.05|TWO_SIDED|95.0|4.5|121.0||This is a calculated p value|Mixed Models Analysis|P-value adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing.||||121|4.5|<0.05
91514525|NCT04295564|182901549|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31||This is a calculated p value|Regression, Logistic|||||1.31|0.27|>0.05
91514526|NCT04295564|182901549|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31|||Regression, Logistic|Adjusted for gestational age at birth (stratification variable)||||1.31|0.27|>0.05
91514527|NCT04537923|182901551|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-1.24|-0.97|||Mixed Models Analysis|||||-0.97|-1.24|<0.001
91514528|NCT04537923|182901552|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-0.89|||<|0.001|TWO_SIDED|95.0|-1.08|-0.7|||Mixed Models Analysis|||||-0.70|-1.08|<0.001
91514529|NCT04537923|182901552|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.3|-0.92|||Mixed Models Analysis|||||-0.92|-1.30|<0.001
91514530|NCT04537923|182901552|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.49|-1.11|||Mixed Models Analysis|||||-1.11|-1.49|<0.001
91514531|NCT04537923|182901553|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|2.25|4.36|||Regression, Logistic|||||4.36|2.25|<0.0001
91514532|NCT04537923|182901553|SUPERIORITY||Odds Ratio (OR)|6.16|||<|0.0001|TWO_SIDED|95.0|4.27|8.88|||Regression, Logistic|||||8.88|4.27|<0.0001
91514533|NCT04537923|182901553|SUPERIORITY||Odds Ratio (OR)|7.94|||<|0.0001|TWO_SIDED|95.0|5.37|11.75|||Regression, Logistic|||||11.75|5.37|<0.0001
91514534|NCT04537923|182901554|SUPERIORITY||LS Mean Difference|-10.7|||<|0.001|TWO_SIDED|95.0|-11.5|-9.9|||Mixed Models Analysis|||||-9.9|-11.5|<0.001
91514535|NCT04537923|182901554|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-14.5|-12.9|||Mixed Models Analysis|||||-12.9|-14.5|<0.001
91514536|NCT04537923|182901554|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-16.7|-15.0|||Mixed Models Analysis|||||-15.0|-16.7|<0.001
91514537|NCT04537923|182901555|SUPERIORITY||LS Mean Difference|-23.2|||<|0.001|TWO_SIDED|95.0|-30.8|-15.7|||Mixed Models Analysis|||||-15.7|-30.8|<0.001
91514538|NCT04537923|182901555|SUPERIORITY||LS Mean Difference|-33.0|||<|0.001|TWO_SIDED|95.0|-40.6|-25.4|||Mixed Models Analysis|||||-25.4|-40.6|<0.001
91514539|NCT04537923|182901555|SUPERIORITY||LS Mean Difference|-31.6|||<|0.001|TWO_SIDED|95.0|-39.3|-23.8|||Mixed Models Analysis|||||-23.8|-39.3|<0.001
91514540|NCT04537923|182901556|SUPERIORITY||LS Mean Difference|-0.9||||0.682|TWO_SIDED|95.0|-5.0|3.3|||Mixed Models Analysis|||||3.3|-5.0|0.682
91514541|NCT04537923|182901556|SUPERIORITY||LS Mean Difference|-5.6||||0.01|TWO_SIDED|95.0|-9.9|-1.4|||Mixed Models Analysis|||||-1.4|-9.9|0.010
91514542|NCT04537923|182901556|SUPERIORITY||LS Mean Difference|-11.8|||<|0.001|TWO_SIDED|95.0|-16.0|-7.5|||Mixed Models Analysis|||||-7.5|-16.0|<0.001
91514543|NCT04537923|182901557|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|5.66|11.83|||Regression, Logistic|||||11.83|5.66|<0.001
91514544|NCT04537923|182901557|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|11.44|24.96|||Regression, Logistic|||||24.96|11.44|<0.001
91514545|NCT04537923|182901557|SUPERIORITY||Odds Ratio (OR)|21.85|||<|0.001|TWO_SIDED|95.0|14.49|32.93|||Regression, Logistic|||||32.93|14.49|<0.001
91514546|NCT04537923|182901558|SUPERIORITY||Odds Ratio (OR)|28.25|||<|0.001|TWO_SIDED|95.0|18.36|43.46|||Regression, Logistic|||||43.46|18.36|<0.001
91514547|NCT04537923|182901558|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.001|TWO_SIDED|95.0|36.76|94.39|||Regression, Logistic|||||94.39|36.76|<0.001
91514548|NCT04537923|182901558|SUPERIORITY||Odds Ratio (OR)|77.76|||<|0.001|TWO_SIDED|95.0|47.49|127.33|||Regression, Logistic|||||127.33|47.49|<0.001
91514549|NCT04537923|182901559|SUPERIORITY||LS Mean Difference|1.5||||0.005|TWO_SIDED|95.0|0.5|2.6|||ANCOVA|||||2.6|0.5|0.005
91514550|NCT04537923|182901559|SUPERIORITY||LS Mean Difference|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
91514551|NCT04537923|182901559|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
91514552|NCT04537923|182901560|SUPERIORITY||LS Mean Difference|1.6||||0.02|TWO_SIDED|95.0|0.3|2.9|||ANCOVA|||||2.9|0.3|0.020
91514553|NCT04537923|182901560|SUPERIORITY||LS Mean Difference|2.8|||<|0.001|TWO_SIDED|95.0|1.5|4.2|||ANCOVA|||||4.2|1.5|<0.001
91514554|NCT04537923|182901560|SUPERIORITY||LS Mean Difference|2.1||||0.004|TWO_SIDED|95.0|0.7|3.5|||ANCOVA|||||3.5|0.7|0.004
91514555|NCT01261611|182901561|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport NG and Placebo arms was performed. A total of 210 subjects were included in the analysis.||||<0.0001
91514556|NCT01261611|182901561|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport and Placebo arms was performed. A total of 213 subjects were included in the analysis.||||<0.0001
91514557|NCT01261611|182901561|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An ANCOVA on the change from baseline with treatment, baseline TWSTRS Total score, BTX status at baseline and pooled centre as explanatory variables had been performed. The non-inferiority margin was 3 points.|LS mean difference|1.532|||||TWO_SIDED|95.0|-0.819|3.883||||||A pre-specified analysis of the LS mean difference between the Dysport NG and Dysport arms was performed. A total of 315 subjects were included in the analysis.||3.883|-0.819|
91514558|NCT01808690|182901645|SUPERIORITY|||||||0.005||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted multivariable models, which included sex, pubertal status, change in BMI, and baseline M/I.||Insulin function was defined as M/I (mg/kg/min)/(insulin). Power calculations were based on data from a small study in youth with poorly controlled T1DM, which reported a significant increase in M/I in the 11 participants treated with Metformin. On the basis of the effect size reported in that study, a sample size of 25 per group and an alpha of 0.05 provided us with 93% power to detect a difference of 1 SD in the primary outcome of M/I.||||0.005
91514559|NCT01808690|182901646|SUPERIORITY|||||||0.46||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of the variable, sex, age, change in VO2peak, change in insulin sensitivity, and treatment condition.||||||0.46
91514560|NCT01808690|182901647|SUPERIORITY|||||||0.04||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.04
91514561|NCT01808690|182901648|SUPERIORITY|||||||0.04||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.04
91514562|NCT01808690|182901649|SUPERIORITY|||||||0.01||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of BMI percentile, diabetes duration, and A1c.||||||0.01
91514563|NCT01808690|182901650|SUPERIORITY|||||||0.03||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.03
91514564|NCT01808690|182901651|SUPERIORITY|||||||0.8||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.8
91514565|NCT00674986|182901660|SUPERIORITY_OR_OTHER||Difference|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.0416|TWO_SIDED|95.0|0.01|0.54|||Fisher Exact|||||0.54|0.01|0.0416
91514566|NCT00674986|182901661|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91514567|NCT00674986|182901662|SUPERIORITY_OR_OTHER|||||||0.2777||95.0|||||t-test, 2 sided|||||||0.2777
91514568|NCT00674986|182901663|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||t-test, 2 sided|||||||0.1160
91514569|NCT00674986|182901664|SUPERIORITY_OR_OTHER|||||||0.1146||95.0|||||t-test, 2 sided|||||||0.1146
91514570|NCT00674986|182901665|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.0470
91514571|NCT00674986|182901666|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
91514572|NCT00377234|182901668|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P \<0.05|Garts Test|||||||<0.0001
91514573|NCT00377234|182901668|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.|Prescott Test|||||||<0.0001
91514574|NCT01024569|182901687|SUPERIORITY||MIXREG Estimate|-1.16|STANDARD_ERROR_OF_MEAN|-2.21||0.027|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.027
91514575|NCT01024569|182901688|SUPERIORITY||MIXREG Estimate|0.4|STANDARD_ERROR_OF_MEAN|2.37||0.02|TWO_SIDED||||||Mixed Effects Random Regression|||Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.||||0.020
91514576|NCT01024569|182901689|SUPERIORITY||MIXREG Estimate|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.029|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.029
91514577|NCT01024569|182901690|SUPERIORITY||MIXREG Estimate|1.06|STANDARD_ERROR_OF_MEAN|0.52||0.042|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.042
91514578|NCT01024569|182901691|SUPERIORITY||MIXREG Estimate|0.39|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED||||||Mixed Effects Random Regression|||||||.001
91514579|NCT03521635|182901710|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.68||0.688|TWO_SIDED|95.0|-2.7|4.0|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release|Mean changes from baseline of PDSS-2 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||4.0|-2.7|0.688
91514580|NCT03521635|182901711|OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.69|TWO_SIDED|95.0|-1.2|0.8|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by patients were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.8|-1.2|0.690
91514581|NCT03521635|182901711|OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.91||0.376|TWO_SIDED|95.0|-2.7|1.1|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by caregivers were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.1|-2.7|0.376
91514582|NCT03521635|182901712|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.333|TWO_SIDED|95.0|-1.9|0.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep night-time sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.7|-1.9|0.333
91579250|NCT03527550|183047881|SUPERIORITY|||||||0.24|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in distress intolerance at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in distress intolerance as a function of condition (interaction of condition X time; reported below).||||.24
91514583|NCT03521635|182901712|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.374|TWO_SIDED|95.0|-0.8|0.3|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep overall night sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.3|-0.8|0.374
91514584|NCT03521635|182901712|OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.352|TWO_SIDED|95.0|-1.4|0.5|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep daytime sleepiness score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.5|-1.4|0.352
91579251|NCT02503852|183047888|SUPERIORITY|||||||0.032|||||||ANCOVA|||||||0.032
91579252|NCT02503852|183047888|OTHER|||||||0.0318||||||P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24|ANCOVA|||Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.||||0.0318
91514585|NCT03521635|182901713|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.259|TWO_SIDED|95.0|-0.8|0.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of EMO sore were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.2|-0.8|0.259
91514586|NCT03521635|182901714|OTHER||Odds Ratio (OR)|0.96||||0.9373|TWO_SIDED|95.0|0.36|2.54|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PDSS-2 score \<18 were performed with treatment and baseline as the independent variables.||2.54|0.36|0.9373
91514587|NCT03521635|182901715|OTHER||Odds Ratio (OR)|2.24||||0.1611|TWO_SIDED|95.0|0.73|7.49|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of EMO score were performed with treatment and baseline as the independent variables.||7.49|0.73|0.1611
91514588|NCT03521635|182901716|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.517|TWO_SIDED|95.0|-2.3|1.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of PDQ-8 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.2|-2.3|0.517
91514589|NCT03521635|182901717|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of CGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
91514590|NCT03521635|182901718|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
91514591|NCT03521635|182901719|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.82|TWO_SIDED|95.0|-1.4|1.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of ESS score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.7|-1.4|0.820
91514592|NCT00492349|182901728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
91514593|NCT00492349|182901729|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||All treatment main and interaction effect p-values were \> 0.05.|ANCOVA|||Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||>0.05
91514594|NCT00492349|182901730|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
91514595|NCT00626522|182901732|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.131|0.28|||ANCOVA|||||0.280|0.131|<0.0001
91514596|NCT00626522|182901732|SUPERIORITY_OR_OTHER||Least squares mean difference|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.18|0.329|||ANCOVA|||||0.329|0.180|<0.0001
91514597|NCT00626522|182901732|SUPERIORITY_OR_OTHER||Least squares mean difference|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.191|0.34|||ANCOVA|||||0.340|0.191|<0.0001
91579253|NCT02285153|183047964|SUPERIORITY||Cox Proportional Hazard|0.434|STANDARD_ERROR_OF_MEAN|1.225||0.57|TWO_SIDED|95.0|0.039|4.792||Due to the low number of participants, the results of the statistical tests must be interpreted with caution!|Chi-squared|||||4.792|0.039|0.57
91579254|NCT02285153|183047965|SUPERIORITY|||||||0.057|||||||Chi-squared|||||||0.057
91514598|NCT01928719|182901737|OTHER||Hazard Ratio (HR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.95|5.58|||Regression, Cox||The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||5.58|1.95|<0.0001
91514599|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|3.4|||<|0.0001|TWO_SIDED|95.0|1.99|5.81||Testing the effect of treatment group in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Age Group, Working Status, and BMI.|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|The reference group is Same Nicotine Content Group.||5.81|1.99|<0.0001
91514600|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.51||||0.06|TWO_SIDED|95.0|0.26|1.03||Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 30-39 to the Age group 18-29.|The reference group is Age equals 18-29.||1.03|0.26|0.06
91514601|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.17|0.66||Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 40-49 to the Age group 18-29.|The reference group is Age equals 18-29.||0.66|0.17|<0.002
91514602|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.16|0.65||Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 50-59 to Age group 18-29.|The reference group is Age equals 18-29.||0.65|0.16|<0.002
91579255|NCT02285153|183047966|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91579256|NCT02285153|183047967|SUPERIORITY|||||||0.467|||||||Chi-squared|||||||0.467
91514603|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.39||||0.1|TWO_SIDED|95.0|0.13|1.18||Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 60-65 to the Age group 18-29.|The reference group is Age equals 18-29.||1.18|0.13|0.1
91514604|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|1.6||||0.1|TWO_SIDED|95.0|0.92|2.66||Testing the effect of working status in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Age, and BMI.||The reference group is not currently working.|The direction of comparison is currently working to not currently working.|2.66|0.92|0.1
91514605|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.25||||0.006|TWO_SIDED|95.0|0.1|0.67||Testing the effect of BMI Normal Weight group (\>=18.5 \& \<25) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Normal Weight (\>=18.5 \& \<25) to Underweight (\<18.5) group.|The reference group is BMI Underweight (\<18.5)||0.67|0.1|0.006
91514606|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.35||||0.034|TWO_SIDED|95.0|0.13|0.92||Testing the effect of BMI Overweight group (\>=25 \& \< 30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Overweight (\>=25 \& \< 30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.92|0.13|0.034
91514607|NCT01928719|182901738|OTHER||Hazard Ratio (HR)|0.31||||0.011|TWO_SIDED|95.0|0.13|0.77||Testing the effect of BMI Obese group (\>=30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Obese (\>=30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.77|0.13|0.011
91514608|NCT01928719|182901739|OTHER||Least Squares Mean Difference|-4.1||||0.0006|TWO_SIDED|95.0|-6.44|-1.75|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-1.75|-6.44|0.0006
91514609|NCT01928719|182901740|OTHER||Least Squares Mean Difference|-136.7|||<|0.0001|TWO_SIDED|95.0|-171.7|-101.7|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-101.7|-171.7|<.0001
91514610|NCT01928719|182901741|OTHER||Least Squares Mean Difference|-4.03||||0.0305|TWO_SIDED|95.0|-7.68|-0.38|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-0.38|-7.68|0.0305
91514611|NCT01928719|182901742|OTHER||Least Squares Mean Difference|1.81||||0.0207|TWO_SIDED|95.0|0.28|3.33|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||3.33|0.28|0.0207
91514612|NCT01928719|182901743|OTHER||Least Squares Mean Difference|-0.16||||0.4191|TWO_SIDED|95.0|-0.56|0.23|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||0.23|-0.56|0.4191
91514613|NCT02099838|182901771|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
91514614|NCT02099838|182901771|SUPERIORITY_OR_OTHER|||||||0.065||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0650
91514615|NCT02099838|182901771|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
91514616|NCT02099838|182901772|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
91514617|NCT02099838|182901772|SUPERIORITY_OR_OTHER|||||||0.0849||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0849
91514618|NCT02099838|182901772|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
91514619|NCT02099838|182901773|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
91514620|NCT02099838|182901773|SUPERIORITY_OR_OTHER|||||||0.2428||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.2428
91579257|NCT02045875|183047984|SUPERIORITY|||||||0.046||||||Effect of interaction of time and treatment group|ANOVA|||||||0.046
91579258|NCT02045875|183047985|OTHER||correlation coefficient|-0.508|||||TWO_SIDED||||||||correlation of asthma control and adherence|||||
91514621|NCT02099838|182901773|SUPERIORITY_OR_OTHER|||||||0.0003||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0003
91514622|NCT02099838|182901774|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
91514623|NCT02099838|182901774|SUPERIORITY_OR_OTHER|||||||0.7353||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05.||||0.7353
91514624|NCT02099838|182901774|SUPERIORITY_OR_OTHER|||||||0.0013||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0013
91514625|NCT02099838|182901775|SUPERIORITY_OR_OTHER|||||||0.1147||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.1147
91514626|NCT02099838|182901775|SUPERIORITY_OR_OTHER|||||||0.4006||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4006
91514627|NCT02099838|182901775|SUPERIORITY_OR_OTHER|||||||0.0614||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0614
91514628|NCT02099838|182901776|SUPERIORITY_OR_OTHER|||||||0.3795||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3795
91514629|NCT02099838|182901776|SUPERIORITY_OR_OTHER|||||||0.4236||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4236
91514630|NCT02099838|182901776|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||1.0000
91514631|NCT02099838|182901777|SUPERIORITY_OR_OTHER|||||||0.3151||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3151
91579259|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.002||||||This is the PCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.002
91579260|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.23||||||This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.23
91579261|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.18||||||This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.18
91514632|NCT02099838|182901777|SUPERIORITY_OR_OTHER|||||||0.6963||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.6963
91514633|NCT02099838|182901777|SUPERIORITY_OR_OTHER|||||||0.3204||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3204
91514634|NCT02099838|182901778|SUPERIORITY_OR_OTHER|||||||0.0038||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0038
91514635|NCT02099838|182901778|SUPERIORITY_OR_OTHER|||||||0.3812||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3812
91514636|NCT02099838|182901778|SUPERIORITY_OR_OTHER|||||||0.0108||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0108
91514637|NCT02099838|182901779|SUPERIORITY_OR_OTHER|||||||0.5476||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5476
91514638|NCT02099838|182901779|SUPERIORITY_OR_OTHER|||||||0.1248||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.1248
91514639|NCT02099838|182901779|SUPERIORITY_OR_OTHER|||||||0.362||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3620
91514640|NCT02099838|182901780|SUPERIORITY_OR_OTHER|||||||0.5636||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5636
91514641|NCT02099838|182901780|SUPERIORITY_OR_OTHER|||||||0.3681||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3681
91514642|NCT02099838|182901780|SUPERIORITY_OR_OTHER|||||||0.2589||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.2589
91514643|NCT02099838|182901781|SUPERIORITY_OR_OTHER|||||||0.7972||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.7972
91514644|NCT02099838|182901781|SUPERIORITY_OR_OTHER|||||||0.7801||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7801
91514645|NCT02099838|182901781|SUPERIORITY_OR_OTHER|||||||0.8744||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.8744
91514646|NCT02099838|182901782|SUPERIORITY_OR_OTHER|||||||0.8034||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.8034
91514647|NCT02099838|182901782|SUPERIORITY_OR_OTHER|||||||0.7675||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7675
91514648|NCT02099838|182901782|SUPERIORITY_OR_OTHER|||||||0.6918||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.6918
91514649|NCT02099838|182901783|SUPERIORITY_OR_OTHER|||||||0.0339||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0339
91514650|NCT02099838|182901783|SUPERIORITY_OR_OTHER|||||||0.0997||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0997
91514651|NCT02099838|182901783|SUPERIORITY_OR_OTHER|||||||0.5015||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.5015
91514652|NCT01175382|182901794|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.||||<.0001
91514653|NCT01175382|182901795|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.||||.0013
91514654|NCT01175382|182901796|SUPERIORITY_OR_OTHER|||||||0.2933|||||||ANCOVA|||Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.||||0.2933
91514655|NCT01175382|182901797|SUPERIORITY_OR_OTHER|||||||0.0051|||||||ANCOVA|||Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.||||0.0051
91514656|NCT01175382|182901798|SUPERIORITY_OR_OTHER|||||||0.1402|||||||ANCOVA|||Analysis of Covariance comparing mean change score among groups controlling for age and baseline score||||.1402
91514657|NCT01175382|182901799|SUPERIORITY_OR_OTHER|||||||0.0015|||||||ANCOVA|||Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.||||0.0015
91514658|NCT01175382|182901800|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.||||<.0001
91514659|NCT01175382|182901801|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||"Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data."||||<.0001
91514660|NCT01175382|182901802|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Cochran-Mantel-Haenszel|||||||0.0022
91514661|NCT01175382|182901803|SUPERIORITY_OR_OTHER|||||||0.0222|||||||Cochran-Mantel-Haenszel|||||||.0222
91514662|NCT01175382|182901804|SUPERIORITY_OR_OTHER|||||||0.0217|||||||Cochran-Mantel-Haenszel|||||||.0217
91514663|NCT01175382|182901805|SUPERIORITY_OR_OTHER|||||||0.669|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.||||0.6690
91514664|NCT01175382|182901806|SUPERIORITY_OR_OTHER|||||||0.0812|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.||||0.0812
91514665|NCT01175382|182901807|SUPERIORITY_OR_OTHER|||||||0.5578|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.||||0.5578
91514666|NCT01175382|182901808|SUPERIORITY_OR_OTHER|||||||0.0279|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.||||0.0279
91514667|NCT01175382|182901809|SUPERIORITY_OR_OTHER|||||||0.2553|||||||ANCOVA|||Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groups||||0.2553
91514668|NCT01175382|182901810|SUPERIORITY_OR_OTHER|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
91514669|NCT01175382|182901811|SUPERIORITY_OR_OTHER|||||||0.8153|||||||Cochran-Mantel-Haenszel|||||||0.8153
91514670|NCT01175382|182901812|SUPERIORITY_OR_OTHER|||||||0.5536|||||||Cochran-Mantel-Haenszel|||||||0.5536
91514671|NCT01175382|182901813|SUPERIORITY_OR_OTHER|||||||0.2035|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing data||||0.2035
91514672|NCT01175382|182901814|SUPERIORITY_OR_OTHER|||||||0.0549|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing data||||.0549
91514673|NCT01175382|182901815|SUPERIORITY_OR_OTHER|||||||0.507|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing data||||0.5070
91514674|NCT01175382|182901816|SUPERIORITY_OR_OTHER|||||||0.0529|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing data||||.0529
91514675|NCT01175382|182901817|SUPERIORITY_OR_OTHER|||||||0.2384|||||||ANCOVA|||Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.||||0.2384
91514676|NCT02019719|182901822|SUPERIORITY_OR_OTHER||E0 (g/dL)|-1.37|||||TWO_SIDED|95.0|-1.72|-1.03|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-1.03|-1.72|
91514677|NCT02019719|182901822|SUPERIORITY_OR_OTHER||ED50 (mg)|21.88|||||TWO_SIDED|95.0|9.99|42.64|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||42.64|9.99|
91514678|NCT02019719|182901822|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.88|||||TWO_SIDED|95.0|3.2|8.61|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.61|3.20|
91514679|NCT02019719|182901822|SUPERIORITY_OR_OTHER||Gamma|1.13|||||TWO_SIDED|95.0|0.7|1.68|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.68|0.70|
91514680|NCT02019719|182901822|SUPERIORITY_OR_OTHER||Var|0.66|||||TWO_SIDED|95.0|0.5|0.88|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||0.88|0.50|
91514681|NCT02019719|182901822|SUPERIORITY_OR_OTHER||MED (mg)|1.98|||||TWO_SIDED|95.0|0.75|3.41|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||3.41|0.75|
91514682|NCT02019719|182901822|SUPERIORITY_OR_OTHER||TD (mg)|3.9|||||TWO_SIDED|95.0|2.2|5.63|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.63|2.20|
91514683|NCT02019719|182901822|SUPERIORITY_OR_OTHER||MAD (mg)|8.65|||||TWO_SIDED|95.0|6.51|11.44|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||11.44|6.51|
91514684|NCT04535037|182901840|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) of group GMC ratio (Infanrix Hexa over Vaxelis group) was above 0.5.|Adjusted GMC Ratio|0.917|||||TWO_SIDED|95.0|0.71|1.185||||The 95% CI for GMC ratio derived from an ANOVA model on log10 transformed concentration was used. GMC was adjusted for DTPA vaccination of the mother.||To demonstrate that the Haemophilus influenzae type b(Hib) response of Infanrix Hexa Group is non-inferior to the Vaxelis Group in terms of anti-PRP GMCs, 1 month post-booster vaccination.||1.185|0.710|
91514685|NCT04535037|182901841|NON_INFERIORITY|Non-inferiority was demonstrated if the non inferiority of anti-PRP GMC ratio was met and the LL of the 2 sided 95% CI on group difference in the percentage (Infanrix Hexa over Vaxelis group) was more than -10%.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-14.1|1.49||||The 2 sided 95% CI of group difference in seroconversion rate (Inv\_group minus Com\_group) was computed based on Miettinen and Nurminen method.||To demonstrate that the Hib response in Infanrix Hexa group is non-inferior to Vaxelis Group in terms of percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL, 1 month post-booster vaccination.||1.49|-14.10|
91514686|NCT02031276|182901849|OTHER||difference in percentage of participants|12.6||||0.0955|TWO_SIDED|95.0|-2.2|27.5|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-tumor necrosis factor (anti-TNF) exposure.||27.5|-2.2|0.0955
91514687|NCT02031276|182901850|OTHER||difference in percentage of participants|13.4||||0.1151|TWO_SIDED|95.0|-3.3|30.1|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||30.1|-3.3|0.1151
91514688|NCT02031276|182901851|OTHER||difference in percentage of participants|12.0||||0.0057|TWO_SIDED|95.0|3.5|20.6|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||20.6|3.5|0.0057
91514689|NCT02031276|182901852|OTHER||difference in percentage of participants|18.7||||0.0104|TWO_SIDED|95.0|4.4|33.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||33.0|4.4|0.0104
91514690|NCT02031276|182901853|OTHER||difference in percentage of participants|2.4||||0.4977|TWO_SIDED|95.0|-4.5|9.2|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||9.2|-4.5|0.4977
91514691|NCT02031276|182901854|OTHER||difference in percentage of participants|7.4||||0.0107|TWO_SIDED|95.0|1.7|13.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||13.0|1.7|0.0107
91514692|NCT02417246|182901860|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|45.1|STANDARD_DEVIATION|222.2||0.3|TWO_SIDED|95.0|-41.1|131.2|||t-test, 2 sided|Average AUC from 0 to 24 hours (0-24) for patients on the 50mg dose of brand name metoprolol ER and Generic B were compared by a paired t-test (n=28)||||131.2|-41.1|0.3
91514693|NCT02417246|182901860|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic B to brand name metoprolol ER falls within 0.8 to 1.25|Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||The analysis included a total of 20 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients.||||||0.95|0.76|
91514694|NCT02417246|182901860|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|176.5||0.8|TWO_SIDED|95.0|-60.0|74.3|||t-test, 2 sided|Average AUC0-24 for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||74.3|-60.0|0.8
91514695|NCT02417246|182901860|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|1.01||This analysis included 21 individuals who were administered brand name metoprolol ER and Generic A, which is less than the initial plan of including 38 patients.||||||1.01|0.86|
91514696|NCT02417246|182901861|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|10.7||0.2|TWO_SIDED|95.0|-1.5|6.6|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic B were compared using a paired t-test (n=29)||||6.6|-1.5|0.2
91514697|NCT02417246|182901861|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic B to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.79|0.95||The analysis included a total of 29 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients||||||0.95|0.79|
91514698|NCT02417246|182901861|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|12.6||0.3|TWO_SIDED|95.0|-7.3|2.3|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||2.3|-7.3|0.3
91514699|NCT02417246|182901861|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23||The analysis included a total of 29 patients on Generic A and brand name metoprolol ER, which is less than a pre-planned sample size of 38.||||||1.23|1.02|
91514700|NCT02417246|182901862|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic B, adjusting for quartile, (quartile\*med) interaction, and treatment assignment.|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0858|TWO_SIDED||||||Mixed Models Analysis|||||||0.0858
91514701|NCT02417246|182901862|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic A, adjusting for quartile,(quartile\*med) interaction, and treatment assignment.|Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0168|TWO_SIDED||||||Mixed Models Analysis||p for medication\*quartile interaction considered significant if p\<0.025.|||||0.0168
91514702|NCT02417246|182901863|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory systolic blood pressure (SBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-2.39||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||0.203
91514703|NCT02417246|182901863|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory diastolic blood pressure (DBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-0.543||||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
91514704|NCT02417246|182901863|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory SBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.371||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.200
91514705|NCT02417246|182901863|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory DBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.329||||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
91514706|NCT02417246|182901864|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|1.233||||0.333|TWO_SIDED||||||Mixed Models Analysis|||||||0.333
91514707|NCT02417246|182901864|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|1.134||||0.368|TWO_SIDED||||||Mixed Models Analysis|||||||0.368
91514708|NCT02896855|182901878|OTHER||Stratified Hazard Ratio|0.69||||0.0418|TWO_SIDED|95.0|0.49|0.99|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||0.99|0.49|0.0418
91579262|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
91579263|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.004||||||This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.004
91579264|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
91514709|NCT02896855|182901878|OTHER||Unstratified Hazard Ratio|0.71||||0.0556|TWO_SIDED|95.0|0.5|1.01|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||1.01|0.50|0.0556
91514710|NCT02896855|182901878|OTHER||Stratified Hazard Ratio|0.6||||0.0008|TWO_SIDED|95.0|0.45|0.81|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.81|0.45|0.0008
91514711|NCT02896855|182901878|OTHER||Unstratified Hazard Ratio|0.63||||0.0019|TWO_SIDED|95.0|0.47|0.85|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.85|0.47|0.0019
91514712|NCT02896855|182901880|OTHER||Stratified Hazard Ratio|0.68||||0.0658|TWO_SIDED|95.0|0.45|1.03|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.03|0.45|0.0658
91514713|NCT02896855|182901880|OTHER||Unstratified Hazard Ratio|0.7||||0.0864|TWO_SIDED|95.0|0.46|1.06|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.06|0.46|0.0864
91514714|NCT02896855|182901882|OTHER||Difference in Objective Response|9.98||||0.1126|TWO_SIDED|95.0|-2.65|22.6|||Cochran-Mantel-Haenszel|Statistical test is stratified by disease type and hormone receptor status.|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1126
91514715|NCT02896855|182901882|OTHER||Difference in Objective Response|9.98||||0.1108|TWO_SIDED|95.0|-2.65|22.6|||Fisher Exact|Unadjusted|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1108
91514716|NCT02896855|182901883|OTHER||Cox Proportional Hazard|0.78||||0.2867|TWO_SIDED|95.0|0.49|1.24|||Log Rank|Two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.24|0.49|0.2867
91514717|NCT02896855|182901890|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.96|0.75|||||The treatment difference for change from baseline to maximum on-treatment decrease in LVEF is defined as Arm B: Pertuzumab minus Arm A: Placebo.|||0.75|-1.96|
91514718|NCT00941603|182901907|SUPERIORITY_OR_OTHER||Difference in percent|-3.5||||0.06|TWO_SIDED|95.0|-7.2|0.2|||ANOVA|Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.2|-7.2|0.06
91514719|NCT00941603|182901907|SUPERIORITY_OR_OTHER||Difference in percent|-3.1||||0.1|TWO_SIDED|95.0|-6.7|0.6||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|ANOVA|||||0.6|-6.7|0.10
91514720|NCT00941603|182901907|SUPERIORITY_OR_OTHER||Difference in percent|-5.7|||<|0.01|TWO_SIDED|95.0|-9.4|-2.0|||ANOVA|||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||-2.0|-9.4|<0.01
91579265|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.21||||||This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.21
91579266|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
91579267|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
91514721|NCT00941603|182901907|SUPERIORITY_OR_OTHER||Difference in percent|-1.3||||0.48|TWO_SIDED|95.0|-5.0|2.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.4|-5.0|0.48
91514722|NCT00941603|182901907|SUPERIORITY_OR_OTHER||Difference in percent|-0.4||||0.85|TWO_SIDED|95.0|-4.0|3.3|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||3.3|-4.0|0.85
91514723|NCT00941603|182901908|SUPERIORITY_OR_OTHER||Difference in percent|-3.0||||0.09|TWO_SIDED|95.0|-6.5|0.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.4|-6.5|0.09
91514724|NCT00941603|182901908|SUPERIORITY_OR_OTHER||Difference in percent|-3.6||||0.04|TWO_SIDED|95.0|-7.1|-0.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-0.2|-7.1|0.04
91514725|NCT00941603|182901908|SUPERIORITY_OR_OTHER||Difference in percent|-4.4||||0.01|TWO_SIDED|95.0|-7.9|-1.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-1.0|-7.9|0.01
91514726|NCT00941603|182901908|SUPERIORITY_OR_OTHER||Difference in percent|-1.4||||0.41|TWO_SIDED|95.0|-4.9|2.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.0|-4.9|0.41
91514727|NCT00941603|182901908|SUPERIORITY_OR_OTHER||Difference in percent|0.7||||0.68|TWO_SIDED|95.0|-2.7|4.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||4.2|-2.7|0.68
91514728|NCT01343407|182901943|OTHER||Difference in Least Squares Means (LSM)|-22.2||||0.011|TWO_SIDED|90.0|-35.7|-8.7|||Linear mixed effects model|||||-8.7|-35.7|0.011
91514729|NCT01343407|182901943|OTHER||Difference in LSM|-18.9||||0.023|TWO_SIDED|90.0|-32.1|-5.8|||Linear mixed effects model|||||-5.8|-32.1|0.023
91514730|NCT01343407|182901944|OTHER||LS Mean Ratio (LSMR)|0.48||||0.006|TWO_SIDED|90.0|0.32|0.72|||Linear mixed effects model||||% Inhibition: 52.2 (90% CI: 28.3, 68.2). The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.72|0.32|0.006
91514731|NCT01343407|182901944|OTHER||LS Mean Ratio (LSMR)|0.58||||0.012|TWO_SIDED|90.0|0.41|0.81|||Linear mixed effects model||||% Inhibition: 42.4 (90% CI: 19.3, 58.8) The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.81|0.41|0.012
91514732|NCT01343407|182901945|OTHER||LSM Difference|85.84|||<|0.001|TWO_SIDED|90.0|65.3|106.4|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||106.4|65.3|<0.001
91514733|NCT01343407|182901945|OTHER||LSM Difference|83.29|||<|0.001|TWO_SIDED|90.0|63.9|102.7|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||102.7|63.9|<0.001
91514734|NCT01767116|182902008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
91514735|NCT01767116|182902008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
91514736|NCT01767116|182902009|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides \>95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).||1.4|-0.5|
91514737|NCT01767116|182902010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
91514738|NCT01767116|182902011|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
91514739|NCT01767116|182902011|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
91514740|NCT00968669|182902014|SUPERIORITY_OR_OTHER|||||||0.435|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.435
91514741|NCT00968669|182902014|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.828
91514742|NCT00968669|182902014|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.628
91514743|NCT00968669|182902015|SUPERIORITY_OR_OTHER|||||||0.271|||||||Pairwise Poisson Regression|||||||0.271
91514744|NCT00968669|182902015|SUPERIORITY_OR_OTHER|||||||0.319|||||||Pairwise Poisson Regression|||||||0.319
91514745|NCT00968669|182902015|SUPERIORITY_OR_OTHER|||||||0.502|||||||Pairwise Poisson Regression|||||||0.502
91514746|NCT00968669|182902016|SUPERIORITY_OR_OTHER|||||||0.756|||||||Pairwise Poisson Regression|||||||0.756
91514747|NCT00968669|182902016|SUPERIORITY_OR_OTHER|||||||0.047|||||||Pairwise Poisson Regression|||||||0.047
91514748|NCT00968669|182902016|SUPERIORITY_OR_OTHER|||||||1|||||||Pairwise Poisson Regression|||||||1.000
91514749|NCT00968669|182902017|SUPERIORITY_OR_OTHER|||||||0.1764|||||||Fisher Exact|||||||0.1764
91514750|NCT00968669|182902017|SUPERIORITY_OR_OTHER|||||||0.4031|||||||Fisher Exact|||||||0.4031
91514751|NCT00968669|182902017|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91514752|NCT00968669|182902018|SUPERIORITY_OR_OTHER|||||||0.8475|||||||Fisher Exact|||||||0.8475
91514753|NCT00968669|182902018|SUPERIORITY_OR_OTHER|||||||0.0811|||||||Fisher Exact|||||||0.0811
91514754|NCT00968669|182902018|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
91579268|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.14||||||This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.14
91514755|NCT00968669|182902019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.938||||0.144|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.144
91514756|NCT00968669|182902019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.395|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.395
91514757|NCT00968669|182902019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.863|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.863
91514758|NCT00968669|182902020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.717|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.717
91514759|NCT00968669|182902020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.07|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.070
91514760|NCT00968669|182902020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.934|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.934
91514761|NCT00968669|182902021|SUPERIORITY_OR_OTHER|||||||0.813|||||||ANOVA|||||||0.813
91514762|NCT00968669|182902021|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||||||0.290
91514763|NCT00968669|182902021|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
91514764|NCT00968669|182902022|SUPERIORITY_OR_OTHER|||||||0.764|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.764
91514765|NCT00968669|182902023|SUPERIORITY_OR_OTHER|||||||0.986|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.986
91514766|NCT00968669|182902024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.7171|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7171
91514767|NCT00968669|182902024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.6219|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6219
91514768|NCT00968669|182902024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.6182|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6182
91514769|NCT00968669|182902025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.712|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7120
91514770|NCT00968669|182902025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.5086|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5086
91514771|NCT00968669|182902025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.887||||0.5184|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5184
91514772|NCT00968669|182902026|SUPERIORITY_OR_OTHER|||||||0.837|||||||Two-sample t-test|||||||0.837
91514773|NCT00968669|182902026|SUPERIORITY_OR_OTHER|||||||0.756|||||||Two-sample t-test|||||||0.756
91514774|NCT00968669|182902026|SUPERIORITY_OR_OTHER|||||||0.224|||||||Two-sample t-test|||||||0.224
91514775|NCT00968669|182902027|SUPERIORITY_OR_OTHER|||||||0.409|||||||Two-sample t-test|||||||0.409
91514776|NCT00968669|182902027|SUPERIORITY_OR_OTHER|||||||0.847|||||||Two-sample t-test|||||||0.847
91514777|NCT00968669|182902027|SUPERIORITY_OR_OTHER|||||||0.968|||||||Two-sample t-test|||||||0.968
91514778|NCT00968669|182902028|SUPERIORITY_OR_OTHER|||||||0.208|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.208
91514779|NCT00968669|182902029|SUPERIORITY_OR_OTHER|||||||0.574|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.574
91514780|NCT03836287|182902035|OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.47|3.72|||Regression, Logistic|||||3.72|1.47|0.0004
91514781|NCT03836287|182902036|OTHER||Mean Difference (Net)|-29.71|STANDARD_ERROR_OF_MEAN|9.543||0.0019|TWO_SIDED|95.0|-48.42|-11.0|||ANCOVA|||||-11.00|-48.42|0.0019
91514782|NCT00298233|182902046|SUPERIORITY_OR_OTHER|||||||0.42||||||Significance assessed at the 5% level for a two-sided comparison|conditional univariate logistic regressi|analysis stratified by study site||Based on previous studies, assumption was made that 30% of children and 55% of adults treated with standard dose oseltamivir would test negative for virus on day five. This would require a sample size of 242 patients to show a 20% absolute improvement in cessation of viral shedding with 85% power and a two sided α of 0.05. To allow for study withdrawals, the target sample size was set at 300 patients.||||0.42
91514783|NCT00298233|182902047|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|||||||0.54
91514784|NCT00298233|182902048|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|Mantel-Haenszel chi-square stratified by study site||||||0.54
91514785|NCT00298233|182902049|SUPERIORITY_OR_OTHER|||||||0.48||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.48
91514786|NCT00298233|182902050|SUPERIORITY_OR_OTHER|||||||0.66||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.66
91514787|NCT00298233|182902051|SUPERIORITY_OR_OTHER|||||||0.58||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.58
91514788|NCT02371369|182902052|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
91514789|NCT02371369|182902053|OTHER|Treatment comparison analysis||||||0.0043|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||0.0043
91514790|NCT02371369|182902054|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
91514791|NCT02371369|182902055|OTHER|Treatment comparison analysis||||||0.0019|||||||Mixed effects model for repeated measure|||Treatment comparison between pexidartinib and placebo groups at Week 25||||0.0019
91514792|NCT02371369|182902056|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
91514793|NCT03855189|182902074|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514794|NCT03855189|182902074|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||<0.01
91514795|NCT03855189|182902074|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||0.06
91514796|NCT03855189|182902075|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
91514797|NCT03855189|182902075|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514798|NCT03855189|182902075|OTHER|||||||0.5|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.50
91514799|NCT03855189|182902078|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514800|NCT03855189|182902078|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514801|NCT03855189|182902078|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
91514802|NCT03855189|182902079|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
91514803|NCT03855189|182902079|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514804|NCT03855189|182902079|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
91514805|NCT03855189|182902080|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
91514806|NCT03855189|182902080|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
91514807|NCT03855189|182902080|OTHER|||||||0.81|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.81
91514808|NCT03855189|182902081|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
91514809|NCT03855189|182902081|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514810|NCT03855189|182902081|OTHER|||||||0.17|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.17
91514811|NCT03855189|182902082|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514812|NCT03855189|182902082|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
91514813|NCT03855189|182902082|OTHER|||||||0.39|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.39
91514814|NCT03855189|182902083|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514815|NCT03855189|182902083|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514816|NCT03855189|182902083|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
91514817|NCT03855189|182902084|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
91514818|NCT03855189|182902084|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514819|NCT03855189|182902084|OTHER|||||||0.54|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.54
91514820|NCT03855189|182902085|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514821|NCT03855189|182902085|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514822|NCT03855189|182902085|OTHER|||||||0.71|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.71
91514823|NCT03855189|182902086|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514824|NCT03855189|182902086|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514825|NCT03855189|182902086|OTHER|||||||0.77|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.77
91514826|NCT03855189|182902087|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
91514827|NCT03855189|182902087|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
91514828|NCT03855189|182902087|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
91514829|NCT03855189|182902088|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514830|NCT03855189|182902088|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514831|NCT03855189|182902088|OTHER|||||||0.59|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.59
91514832|NCT03855189|182902089|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
91514833|NCT03855189|182902089|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514834|NCT03855189|182902089|OTHER|||||||0.43|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.43
91514835|NCT03855189|182902090|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
91514836|NCT03855189|182902090|OTHER|||||||0.08|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.08
91514837|NCT03855189|182902090|OTHER|||||||0.96|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.96
91514838|NCT03855189|182902091|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514839|NCT03855189|182902091|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514840|NCT03855189|182902091|OTHER|||||||0.64|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.64
91514841|NCT03855189|182902092|OTHER|||||||0.25|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.25
91514842|NCT03855189|182902092|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
91514843|NCT03855189|182902092|OTHER|||||||0.26|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.26
91514844|NCT03855189|182902093|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514845|NCT03855189|182902093|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514846|NCT03855189|182902093|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
91514847|NCT03855189|182902094|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
91514848|NCT03855189|182902094|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514849|NCT03855189|182902094|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
91514850|NCT03855189|182902095|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
91514851|NCT03855189|182902095|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514852|NCT03855189|182902095|OTHER|||||||0.53|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.53
91514853|NCT03855189|182902096|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
91514854|NCT03855189|182902096|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514855|NCT03855189|182902096|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
91514856|NCT03855189|182902097|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
91514857|NCT03855189|182902097|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514858|NCT03855189|182902097|OTHER|||||||0.34|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.34
91514859|NCT03855189|182902098|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514860|NCT03855189|182902098|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514861|NCT03855189|182902098|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
91514862|NCT03855189|182902099|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
91514863|NCT03855189|182902099|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514864|NCT03855189|182902099|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
91514865|NCT03855189|182902100|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
91514866|NCT03855189|182902100|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514867|NCT03855189|182902100|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
91514868|NCT03855189|182902101|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
91514869|NCT03855189|182902101|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
91514870|NCT03855189|182902101|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
91514871|NCT00167544|182902105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||<|0.05|TWO_SIDED|95.0|-19.49|30.29|||ANCOVA|||The primary analysis of total brain tissue volume was performed using multiple linear regression controlling for postmenstrual age at MRI scan to adjust for differences in timing at MRI. The distributions of potentially important confounding variables at baseline were compared in the two groups using parametric and non-parametric tests as appropriate. All analyses were performed using STATA 11.0. Please see PubMed: 23140612.||30.29|-19.49|<0.05
91514872|NCT04307186|182902109|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."|||||<|0.0001||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 1||||<0.0001
91514873|NCT04307186|182902109|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.5775||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 2||||0.5775
91514874|NCT04307186|182902109|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.3173||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 3||||0.3173
91514875|NCT04307186|182902110|NON_INFERIORITY|The non-inferiority of gadoquatrane versus gadobutrol was evaluated using CIs based on the t-distribution. A non-inferiority margin of 1 was used, i.e. meaning that a 95% two-sided CI for the mean difference gadoquatrane minus gadobutrol score must exclude the value -1.|Mean Difference (Final Values)|-0.05|||<|0.0001|TWO_SIDED|95.0|-0.24|0.13||P-Value was calculated. Non-inferiority was achieved with a one-sided p-value lower than 0.025.|t-test, 1 sided|||Average reader||0.13|-0.24|<0.0001
91514876|NCT04307186|182902111|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|1.06|1.34|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.34|1.06|
91514877|NCT04307186|182902111|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.94|1.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.25|0.94|
91514878|NCT04307186|182902112|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.07|||||TWO_SIDED|95.0|1.87|2.28|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.28|1.87|
91514879|NCT04307186|182902112|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.06|||||TWO_SIDED|95.0|1.86|2.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.25|1.86|
91514880|NCT04307186|182902113|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.27|||||TWO_SIDED|95.0|1.11|1.43|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.43|1.11|
91514881|NCT04307186|182902113|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|1.05|1.32|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.32|1.05|
91514882|NCT01587651|182902133|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.|Mean Difference (Final Values)|46.0|STANDARD_ERROR_OF_MEAN|10.66|||TWO_SIDED|95.0|24.9|67.2||||||ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.||67.2|24.9|
91579269|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.45||||||This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.45
91579270|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.79||||||This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.79
91514883|NCT00754845|182902139|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.91|||Log Rank|Stratified by the stratification factors at randomization||||0.91|0.48|0.01
91514884|NCT00754845|182902140|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
91514885|NCT00754845|182902141|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.83|TWO_SIDED|95.0|0.73|1.28|||Log Rank|||||1.28|0.73|0.83
91514886|NCT00754845|182902142|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
91514887|NCT00358735|182902149|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91514888|NCT00358735|182902150|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
91514889|NCT00358735|182902151|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||||||0.0004
91514890|NCT00358735|182902153|SUPERIORITY_OR_OTHER|||||||0.953|||||||Chi-squared|||||||0.953
91514891|NCT00358735|182902154|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.050
91514892|NCT00358735|182902155|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
91514893|NCT00358735|182902156|SUPERIORITY_OR_OTHER|||||||0.507|||||||Chi-squared|||||||0.507
91514894|NCT00358735|182902157|SUPERIORITY_OR_OTHER|||||||0.052|||||||Chi-squared|||||||0.052
91514895|NCT00358735|182902158|SUPERIORITY_OR_OTHER|||||||0.798|||||||Chi-squared|||||||0.798
91514896|NCT00358735|182902159|SUPERIORITY_OR_OTHER|||||||0.036|||||||Chi-squared|||||||0.036
91514897|NCT03238001|182902168|NON_INFERIORITY|In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.|Lower 90% CL for difference in Kappas|-0.12|||||TWO_SIDED|90.0|-0.12|0.05|||||90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).|A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.||0.05|-0.12|
91514898|NCT00780962|182902181|SUPERIORITY||Percentage Difference|0.6|||>|0.5|TWO_SIDED|95.0|-4.8|6.0|||Wald|||"The study was powered to find a 10% absolute risk reduction in the rate of contrast-induced nephropathy (a=.05, 90% power). We initially estimated the need for 600 patients and repowered to 800 patients after the 1st interim analysis. The study was halted for futility at the 2nd interim analysis.~Reported here 357 (89.4%) of the 399 enrolled subjects who completed a second blood draw at the time the study closed."||6.0|-4.8|>0.5
91514899|NCT05732454|182902218|SUPERIORITY||Difference in percentage|-3.76|||=|0.558|TWO_SIDED|95.0|-16.36|8.83|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||8.83|-16.36|=0.5580
91514900|NCT05732454|182902219|SUPERIORITY||Difference in percentage|9.07|||=|0.3685|TWO_SIDED|95.0|-10.7|28.85|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||28.85|-10.70|=0.3685
91514901|NCT05732454|182902220|SUPERIORITY||Difference in Mean|-29.22|||=|0.0303|TWO_SIDED|95.0|-55.53|-2.9|||Rubin's rule|||Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin's rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.||-2.90|-55.53|=0.0303
91514902|NCT01262651|182902255|SUPERIORITY||Median Difference (Final Values)|3.41||||0.0854|TWO_SIDED|95.0|0.0|8.16|||Wilcoxon (Mann-Whitney)|||||8.16|0.00|0.0854
91514903|NCT03822533|182902268|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.69|TWO_SIDED|95.0|-0.059|0.089|||t-test, 2 sided|||Mean difference using independent samples t-test.||0.089|-0.059|0.69
91514904|NCT03822533|182902268|SUPERIORITY||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.093|0.063||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||Presenting β-values from linear regression analysis for group variable adjusted for baseline differences in EQ-5D-3L-index. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||0.063|-0.093|
91514905|NCT03822533|182902269|SUPERIORITY||Mean Difference (Final Values)|-364.0||||0.17|TWO_SIDED|95.0|-891.0|164.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||164|-891|0.17
91514906|NCT03822533|182902269|SUPERIORITY||Mean Difference (Final Values)|-364.0|||||TWO_SIDED|95.0|-870.0|143.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||||143|-870|
91514907|NCT03822533|182902270|SUPERIORITY||Mean Difference (Final Values)|-233.0||||0.23|TWO_SIDED|95.0|-616.0|150.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||150|-616|0.23
91514908|NCT03822533|182902270|SUPERIORITY||Mean Difference (Final Values)|-233.0|||||TWO_SIDED|95.0|-605.0|139.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis.||Linear regression analysis. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||139|-605|
91514909|NCT03822533|182902273|SUPERIORITY||Mean Difference (Final Values)|48.0||||0.72|TWO_SIDED|95.0|-219.0|314.0|||t-test, 2 sided|||||314|-219|0.72
91514910|NCT03822533|182902274|SUPERIORITY||Mean Difference (Final Values)|-178.0|||<|0.01|TWO_SIDED|95.0|-239.0|118.0|||t-test, 2 sided|||||118|-239|<0.01
91514911|NCT03822533|182902275|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.01|TWO_SIDED|95.0|-42.0|6.2|||t-test, 2 sided|||||6.2|-42|0.01
91514912|NCT03822533|182902276|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.62|TWO_SIDED|95.0|-59.0|36.0|||t-test, 2 sided|||||36|-59|0.62
91514913|NCT03822533|182902277|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.87|TWO_SIDED|95.0|-13.0|15.0|||t-test, 2 sided|||||15|-13|0.87
91514914|NCT03822533|182902278|SUPERIORITY||Mean Difference (Final Values)|-254.0||||0.27|TWO_SIDED|95.0|-728.0|220.0|||t-test, 2 sided|||||220|-728|0.27
91514915|NCT03822533|182902279|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-113.0|118.0|||t-test, 2 sided|||||118|-113|0.96
91514916|NCT00304070|182902338|OTHER||2 Year EFS|0.89||||0.44|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.44
91514917|NCT00304070|182902338|OTHER||2 Year EFS|0.53||||0.4|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.40
91514918|NCT00304070|182902338|OTHER||2 Year EFS|0.55||||8.53e-06|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.00000853
91514919|NCT04118348|182902347|SUPERIORITY||Odds Ratio (OR)|5.73|||<|0.001|TWO_SIDED|95.0|4.46|7.36|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||7.36|4.46|<.001
91514920|NCT04118348|182902347|SUPERIORITY||Odds Ratio (OR)|4.87|||<|0.001|TWO_SIDED|95.0|3.79|6.27|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||6.27|3.79|<.001
91514921|NCT04118348|182902347|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.19|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.19|1.28|<.001
91514922|NCT04118348|182902347|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|2.73|4.29|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||4.29|2.73|<.001
91514923|NCT04118348|182902347|SUPERIORITY||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|2.32|3.66|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||3.66|2.32|<.001
91514924|NCT04118348|182902347|SUPERIORITY||Odds Ratio (OR)|1.17||||0.114|TWO_SIDED|95.0|0.96|1.43|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.43|0.96|.114
91514925|NCT04118348|182902348|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|2.02|4.15|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||4.15|2.02|<.001
91514926|NCT04118348|182902348|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.57|3.3|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||3.30|1.57|<.001
91514927|NCT04118348|182902348|SUPERIORITY||Odds Ratio (OR)|1.54||||0.03|TWO_SIDED|95.0|1.04|2.27|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.27|1.04|.030
91514928|NCT04118348|182902348|SUPERIORITY||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.59|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||2.59|1.37|<.001
91514929|NCT04118348|182902348|SUPERIORITY||Odds Ratio (OR)|1.48||||0.021|TWO_SIDED|95.0|1.06|2.06|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||2.06|1.06|.021
91514930|NCT04118348|182902348|SUPERIORITY||Odds Ratio (OR)|1.27||||0.107|TWO_SIDED|95.0|0.95|1.71|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.71|0.95|.107
91514931|NCT00779246|182902349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||>|0.05|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.||2.9|0.5|>0.05
91514932|NCT01046643|182902377|SUPERIORITY_OR_OTHER|||||||0.222||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.222
91514933|NCT01046643|182902377|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.107
91514934|NCT01046643|182902377|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.127
91514935|NCT01046643|182902377|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.954
91514936|NCT01046643|182902377|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.385
91514937|NCT01046643|182902377|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.310
91514938|NCT01046643|182902378|SUPERIORITY_OR_OTHER|||||||0.594||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.594
91514939|NCT01046643|182902378|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.653
91514940|NCT01046643|182902379|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.452
91514941|NCT01046643|182902379|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.868
91514942|NCT01046643|182902379|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.549
91514943|NCT01046643|182902379|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.124
91514944|NCT01046643|182902379|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.158
91514945|NCT01046643|182902379|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.055
91514946|NCT01046643|182902380|SUPERIORITY_OR_OTHER|||||||0.561||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.561
91514947|NCT01046643|182902380|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.726
91514948|NCT00823082|182902422|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
91514949|NCT00823082|182902423|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91514950|NCT00823082|182902424|SUPERIORITY_OR_OTHER|||||||0.6115|TWO_SIDED||||||Fisher Exact|||At ICU discharge visit||||0.6115
91514951|NCT00823082|182902425|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||0.1211
91514952|NCT00823082|182902425|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||1.000
91514953|NCT00823082|182902426|SUPERIORITY_OR_OTHER|||||||0.487|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.4870
91514954|NCT00823082|182902427|SUPERIORITY_OR_OTHER|||||||0.3897|TWO_SIDED||||||Hodges-Lehmann test|||||||0.3897
91514955|NCT00823082|182902428|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
91514956|NCT00823082|182902429|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||||||0.0004
91514957|NCT00823082|182902430|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||ANCOVA|||||||0.0209
91514958|NCT00823082|182902431|SUPERIORITY_OR_OTHER|||||||0.7433|TWO_SIDED||||||ANCOVA|||Number of units of packed red blood cells||||0.7433
91514959|NCT00823082|182902431|SUPERIORITY_OR_OTHER|||||||0.7453|TWO_SIDED||||||ANCOVA|||Units of fresh frozen plasma||||0.7453
91514960|NCT00823082|182902431|SUPERIORITY_OR_OTHER|||||||0.2705|TWO_SIDED||||||ANCOVA|||Units of platelets||||0.2705
91514961|NCT00823082|182902432|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||||||0.4460
91514962|NCT00823082|182902433|SUPERIORITY_OR_OTHER|||||||0.4936|TWO_SIDED||||||Fisher Exact|||||||0.4936
91514963|NCT00823082|182902434|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||1.000
91514964|NCT00823082|182902434|SUPERIORITY_OR_OTHER|||||||0.6218|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.6218
91514965|NCT00823082|182902435|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED||||||Hodges-Lehmann|||||||0.9574
91514966|NCT00823082|182902436|SUPERIORITY_OR_OTHER|||||||0.7489|||||||Hodges-Lehmann test|||||||0.7489
91514967|NCT03452917|182902437|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.82|ONE_SIDED|95.0|-8.0||||Chi-squared||||||-8.0|0.82
91514968|NCT03452917|182902437|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.66|ONE_SIDED|95.0|-6.5||||Chi-squared||||||-6.5|0.66
91514969|NCT03452917|182902438|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.44|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.44
91514970|NCT03452917|182902438|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
91514971|NCT03452917|182902439|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|95.0|-0.9|5.4|||Wilcoxon (Mann-Whitney)|||||5.4|-0.9|0.12
91514972|NCT03452917|182902439|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.41|TWO_SIDED|95.0|-2.5|3.6|||Wilcoxon (Mann-Whitney)|||||3.6|-2.5|0.41
91514973|NCT03452917|182902440|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.42|TWO_SIDED|95.0|-8.3|3.5|||Chi-squared|||||3.5|-8.3|0.42
91514974|NCT03452917|182902440|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.49|TWO_SIDED|95.0|-8.0|3.9|||Chi-squared|||||3.9|-8.0|0.49
91514975|NCT03452917|182902441|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.93|TWO_SIDED|95.0|-7.8|8.6|||Chi-squared|||||8.6|-7.8|0.93
91514976|NCT03452917|182902441|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.2|TWO_SIDED|95.0|-2.8|13.3|||Chi-squared|||||13.3|-2.8|0.20
91514977|NCT03452917|182902442|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5|TWO_SIDED|95.0|-7.7|3.8|||Chi-squared|||||3.8|-7.7|0.50
91514978|NCT03452917|182902442|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.48|TWO_SIDED|95.0|-7.8|3.7|||Chi-squared|||||3.7|-7.8|0.48
91514979|NCT03452917|182902443|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.49|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.49
91514980|NCT03452917|182902443|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
91514981|NCT03198000|182902444|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44).|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.049||0.392|TWO_SIDED|95.0|-0.14|0.055|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.055|-0.140|0.392
91514982|NCT03198000|182902444|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44)|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.828|TWO_SIDED|95.0|-0.086|0.107|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.107|-0.086|0.828
91514983|NCT03198000|182902445|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25).|Odds Ratio (OR)|0.87||||0.576|TWO_SIDED|95.0|0.539|1.411|||GEE model|GEE model with treatment as factor.||||1.411|0.539|0.576
91514984|NCT03198000|182902445|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25)|Odds Ratio (OR)|0.87||||0.544|TWO_SIDED|95.0|0.552|1.368|||GEE model|GEE model with treatment as factor.||||1.368|0.552|0.544
91514985|NCT03198000|182902446|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.893|TWO_SIDED|95.0|-0.085|0.074|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.074|-0.085|0.893
91514986|NCT03198000|182902446|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.886|TWO_SIDED|95.0|-0.073|0.084|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.084|-0.073|0.886
91514987|NCT03198000|182902447|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.117|TWO_SIDED|95.0|-0.177|0.02|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.020|-0.177|0.117
91514988|NCT03198000|182902447|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.255|TWO_SIDED|95.0|-0.153|0.041|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.041|-0.153|0.255
91514989|NCT03198000|182902449|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.085|TWO_SIDED|95.0|-0.05|0.78|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.78|-0.05|0.085
91514990|NCT03198000|182902449|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.269|TWO_SIDED|95.0|-0.18|0.64|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.64|-0.18|0.269
91514991|NCT03198000|182902450|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.162|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.10|-0.60|0.162
91514992|NCT03198000|182902450|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234|TWO_SIDED|95.0|-0.55|0.14|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.14|-0.55|0.234
91514993|NCT03198000|182902451|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.398|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.19|-0.48|0.398
91514994|NCT03198000|182902451|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.233|TWO_SIDED|95.0|-0.54|0.13|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.13|-0.54|0.233
91514995|NCT04102501|182902499|SUPERIORITY|||||||0.5858|||||||Mixed Models Analysis|||||||0.5858
91514996|NCT04102501|182902500|SUPERIORITY|||||||0.8061|||||||Mixed Models Analysis|||||||0.8061
91514997|NCT04433767|182902515|OTHER||Slope|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age and gender.||||||< 0.001
91514998|NCT04433767|182902517|OTHER||Intercept|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0127|TWO_SIDED|95.0|0.04|0.32|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.32|0.04|0.0127
91514999|NCT04433767|182902518|OTHER||Intercept|0.34|STANDARD_ERROR_OF_MEAN|0.08||0.0005|TWO_SIDED|95.0|0.17|0.51|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.51|0.17|0.0005
91515000|NCT04433767|182902519|OTHER||Intercept|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1027|TWO_SIDED|95.0|-0.04|0.42|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.42|-0.04|0.1027
91515001|NCT04433767|182902520|OTHER||Intercept|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4846|TWO_SIDED|95.0|-0.18|0.37|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.37|-0.18|0.4846
91515002|NCT04433767|182902521|OTHER||Intercept|9.04|STANDARD_ERROR_OF_MEAN|25.77||0.729|TWO_SIDED|95.0|-44.28|62.36|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||62.36|-44.28|0.7290
91515003|NCT04433767|182902522|OTHER||Intercept|-0.25|STANDARD_ERROR_OF_MEAN|2.43||0.9196|TWO_SIDED|95.0|-5.28|4.78|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||4.78|-5.28|0.9196
91515004|NCT04433767|182902523|OTHER||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.033|TWO_SIDED|95.0|0.01|0.33|||Mixed Models Analysis|Adjusted for age and gender.||||0.33|0.01|0.033
91515005|NCT04433767|182902524|OTHER||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|95.0|0.01|0.35|||Mixed Models Analysis|Adjusted for age and gender.||||0.35|0.01|0.041
91515006|NCT04433767|182902525|OTHER||Slope|-11.13|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.81|-4.45|||Mixed Models Analysis|Adjusted for age and gender.||||-4.45|-17.81|0.001
91515007|NCT04433767|182902526|OTHER||Slope|-12.64|STANDARD_ERROR_OF_MEAN|3.68||0.001|TWO_SIDED|95.0|-19.94|-5.33|||Mixed Models Analysis|Adjusted for age and gender.||||-5.33|-19.94|0.001
91515008|NCT04433767|182902527|OTHER||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.32|||Mixed Models Analysis|||||-0.32|-1.15|<0.001
91515009|NCT04433767|182902528|OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.92|-0.34|||Mixed Models Analysis|Adjusted for age and gender.||||-0.34|-0.92|0.001
91515010|NCT04433767|182902529|OTHER||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.18|||Mixed Models Analysis|Adjusted for age and gender.||||-0.18|-0.65|<0.001
91515011|NCT04433767|182902530|OTHER||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.183|TWO_SIDED|95.0|-1.17|0.23|||Mixed Models Analysis|Adjusted for age and gender.||||0.23|-1.17|0.183
91515012|NCT04433767|182902531|OTHER||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.17|TWO_SIDED|95.0|-0.74|0.13|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.13|-0.74|0.170
91515013|NCT04433767|182902532|OTHER||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.051|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.80|0.00|0.051
91515014|NCT04433767|182902533|OTHER||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|Analyses adjusted for age and gender.||||-0.11|-0.33|<0.001
91515015|NCT04433767|182902534|OTHER||Slope|0.43|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|0.17|0.69|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.69|0.17|0.002
91515016|NCT04433767|182902535|OTHER||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|0.21|0.83|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.83|0.21|0.002
91515017|NCT04433767|182902536|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.55||0.876|TWO_SIDED|95.0|-1.05|1.23|||Mixed Models Analysis|Analyses adjusted for age and gender.||||1.23|-1.05|0.876
91515018|NCT03176693|182902550|EQUIVALENCE|A power analysis was calculated based on findings reported by Weingarten et al. of more frequent episodes of hypotension (defined as difference of mean systolic blood pressure \<30% from baseline) in phenoxybenzamine compared with doxazosin (15.7% versus 5.1%). Using a standard deviation of 16 and 11 (derived from reported interquartile ranges, assuming normal distribution), respectively, to achieve 80% power using an alpha =.05, a total sample size of 56 patients was determined.||||||0.56||||||Threshold for statistical significance = 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: hemodynamic instability time will not differ between arms||||.56
91515019|NCT03325712|182902557|OTHER||Slope|0.8188|STANDARD_ERROR_OF_MEAN|0.0725|||TWO_SIDED|90.0|0.6966|0.941|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9410|0.6966|
91515020|NCT03325712|182902558|OTHER||Slope|0.7708|STANDARD_ERROR_OF_MEAN|0.0747|||TWO_SIDED|90.0|0.6449|0.8967|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.8967|0.6449|
91515021|NCT03325712|182902559|OTHER||Slope|0.7167|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|0.4922|0.9412|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9412|0.4922|
91515022|NCT03325712|182902560|OTHER||Slope|0.6825|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|90.0|0.4556|0.9094|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9094|0.4556|
91515023|NCT03325712|182902561|OTHER||Ratio (T/R)|102.81|STANDARD_DEVIATION|17.5|||TWO_SIDED|90.0|87.18|121.25||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||121.25|87.18|
91515024|NCT03325712|182902561|OTHER||Ratio (T/R)|93.06|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|79.94|108.32||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||108.32|79.94|
91515025|NCT03325712|182902561|OTHER||Ratio (T/R)|109.82|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|103.59|116.42||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||116.42|103.59|
91515026|NCT03325712|182902561|OTHER||Ratio ( T/R)|108.37|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|92.0|127.66||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||127.66|92.00|
91515027|NCT03325712|182902561|OTHER||Ratio (T/R)|109.11|STANDARD_DEVIATION|17.6|||TWO_SIDED|90.0|92.43|128.79||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||128.79|92.43|
91515028|NCT03325712|182902562|OTHER||Ratio (T/R)|100.1|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|83.99|119.31||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||119.31|83.99|
91515029|NCT03325712|182902562|OTHER||Ratio (T/R)|84.43|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|72.29|98.62||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||98.62|72.29|
91515030|NCT03325712|182902562|OTHER||Ratio (T/R)|109.41|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|94.34|126.88||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||126.88|94.34|
91515031|NCT03325712|182902562|OTHER||Ratio (T/R)|95.44|STANDARD_DEVIATION|19.1|||TWO_SIDED|90.0|79.75|114.21||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.21|79.75|
91515032|NCT03325712|182902562|OTHER||Ratio (T/R)|90.04|STANDARD_DEVIATION|25.9|||TWO_SIDED|90.0|70.75|114.59||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.59|70.75|
91579271|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
91579272|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.03||||||This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.03
91515033|NCT02265237|182902563|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|100.0|||||TWO_SIDED|97.5|92.4|100.0|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||100.0|92.4|
91515034|NCT02265237|182902563|SUPERIORITY|97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.|Percentage of Participants|96.6|||||TWO_SIDED|97.5|86.7|99.2|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||99.2|86.7|
91515035|NCT02265237|182902563|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|93.4|||||TWO_SIDED|97.5|82.6|97.7|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||97.7|82.6|
91515036|NCT02265237|182902564|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|-3.39||||0.304|TWO_SIDED|95.0|-9.85|3.07|||Mantel Haenszel|||Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.||3.07|-9.85|0.304
91515037|NCT02265237|182902565|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|6.45||||0.086|TWO_SIDED|95.0|-0.91|13.81|||Mantel Haenszel|||Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.||13.81|-0.91|0.086
91515038|NCT00839072|182902589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax does not exceed 125%.|Ratio of the mean|59.66|||||TWO_SIDED|90.0|50.99|69.81|||||Trazodone Contramid® OAD/Desyrel®|||69.81|50.99|
91515039|NCT00839072|182902590|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCT is between 80% and 125%.|Ratio of the mean|78.55|||||TWO_SIDED|90.0|69.7|88.51|||||Trazodone Contramid® OAD/Desyrel®|||88.51|69.70|
91515040|NCT00839072|182902591|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC∞ is between 80% and 125%.|Ratio of the mean|80.05|||||TWO_SIDED|90.0|70.67|90.68|||||Trazodone Contramid® OAD/Desyrel®|||90.68|70.67|
91515041|NCT00380068|182902595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.5|STANDARD_DEVIATION|65.64|<|0.001||95.0|11.8|29.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||29.3|11.8|<0.001
91515042|NCT00380068|182902596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.11|<|0.001||95.0|-0.8|-0.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||-0.3|-0.8|<0.001
91515043|NCT00380068|182902597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.001||95.0|-1.0|-0.2|||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||-0.2|-1.0|0.001
91515044|NCT00380068|182902598|SUPERIORITY_OR_OTHER||Percent change from baseline|-25.5||||||95.0|-33.6|-16.3|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.3|-33.6|
91515045|NCT00380068|182902599|SUPERIORITY_OR_OTHER||Percent change from baseline|-29.2||||||95.0|-39.8|-16.6|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.6|-39.8|
91515046|NCT00380068|182902600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
91515047|NCT00380068|182902601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
91515048|NCT00380068|182902602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||||<0.001
91515049|NCT00380068|182902603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||||<0.001
91515050|NCT00380068|182902604|SUPERIORITY_OR_OTHER||percent event free|89.4||||||95.0|84.4|92.8|||||Estimate obtained through Kaplan-Meier methods|||92.8|84.4|
91515051|NCT00380068|182902605|SUPERIORITY_OR_OTHER||percent event free|84.1||||||95.0|78.2|88.6|||||Estimate obtained through Kaplan-Meier methods|||88.6|78.2|
91515052|NCT00380068|182902606|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.4|97.4|||||Estimate obtained through Kaplan-Meier methods|||97.4|91.4|
91515053|NCT00380068|182902607|SUPERIORITY_OR_OTHER||percent event free|92.9||||||95.0|88.3|95.8|||||Estimate obtained through Kaplan-Meier methods|||95.8|88.3|
91515054|NCT00380068|182902608|SUPERIORITY_OR_OTHER||percent event free|95.0||||||95.0|88.5|97.9|||||Estimate obtained through Kaplan-Meier methods|||97.9|88.5|
91515055|NCT00380068|182902609|SUPERIORITY_OR_OTHER||percent event free|90.0||||||95.0|81.6|94.7|||||Estimate obtained through Kaplan-Meier methods|||94.7|81.6|
91515056|NCT00380068|182902610|SUPERIORITY_OR_OTHER||percent event free|97.1||||||95.0|93.6|98.7|||||Estimate obtained through Kaplan-Meier methods|||98.7|93.6|
91515057|NCT00380068|182902611|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.2|97.6|||||Estimate obtained through Kaplan-Meier methods|||97.6|91.2|
91515058|NCT01297062|182902612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.36|||||TWO_SIDED|90.0|-2.21|-0.5||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.50|-2.21|
91515059|NCT01297062|182902613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-2.02|||||TWO_SIDED|90.0|-2.88|-1.16||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-1.16|-2.88|
91515060|NCT01297062|182902614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.13|||||TWO_SIDED|90.0|-2.11|-0.15||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.15|-2.11|
91515061|NCT01297062|182902615|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47|||||TWO_SIDED|90.0|2.82|8.12|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||8.12|2.82|
91515062|NCT01297062|182902616|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|8.46|12.67|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||12.67|8.46|
91515063|NCT01297062|182902617|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.92|||||TWO_SIDED|90.0|8.71|13.13|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||13.13|8.71|
91515064|NCT01297062|182902620|SUPERIORITY_OR_OTHER||Slope|0.0008||||0.5962|TWO_SIDED|90.0|-0.0017|0.0033|||Mixed Models Analysis||The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.|The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.||0.0033|-0.0017|0.5962
91515065|NCT03191903|182902621|SUPERIORITY|||||||0.5874|||||||ANOVA|||||||0.5874
91515066|NCT03191903|182902622|SUPERIORITY|||||||0.0829|||||||ANOVA|||||||0.0829
91515067|NCT03191903|182902623|SUPERIORITY|||||||0.4673|||||||ANOVA|||||||0.4673
91515068|NCT03191903|182902624|SUPERIORITY|||||||0.9408|||||||ANOVA|||||||0.9408
91579273|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.12||||||This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.12
91515069|NCT03191903|182902625|SUPERIORITY|||||||0.777|||||||ANOVA|||||||0.7770
91515070|NCT03191903|182902626|SUPERIORITY|||||||0.759|||||||ANOVA|||||||0.7590
91515071|NCT03191903|182902627|SUPERIORITY|||||||0.8309|||||||ANOVA|||||||0.8309
91515072|NCT03191903|182902628|SUPERIORITY|||||||0.6215|||||||ANOVA|||||||0.6215
91515073|NCT03191903|182902629|SUPERIORITY|||||||0.216|||||||ANOVA|||||||0.2160
91515074|NCT03191903|182902630|SUPERIORITY|||||||0.7026|||||||ANOVA|||||||0.7026
91515075|NCT03191903|182902631|SUPERIORITY|||||||0.0438|||||||ANOVA|||||||0.0438
91515076|NCT03149328|182902632|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.3||||||Threshold for statistical significance was p=0.05|ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis is that both groups are the same.||||0.30
91515077|NCT03149328|182902633|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.28|||||||ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis = both groups are the same||||0.28
91515078|NCT03149328|182902634|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.22||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of hospitalizations"||||0.22
91515079|NCT03149328|182902634|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.1||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of emergency room visits"||||0.10
91515080|NCT03149328|182902635|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.18||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.18
91515081|NCT03149328|182902636|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.79||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.79
91515082|NCT03149328|182902637|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)|||||<|0.001||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||<0.001
91515083|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.156||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.001
91515084|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.161||0.356|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count; a=0.05|Mixed Models Analysis|||Cough or Shortness of Breath||||0.356
91515085|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.163||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.001
91515086|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.141||0.962|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Diarrhea||||0.962
91515087|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.162||0.651|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Difficulty falling or staying asleep||||0.651
91515088|NCT02897141|182902673|SUPERIORITY|Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.145||0.23|TWO_SIDED||||||Mixed Models Analysis|||Difficulty remembering||||0.230
91515089|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.126||0.275|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Dizziness||||0.275
91515090|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.175||0.987|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.987
91515091|NCT02897141|182902673|SUPERIORITY||Mean Difference (Net)|-0.275|STANDARD_ERROR_OF_MEAN|0.132||0.037|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fever, chills, sweats||||0.037
91515092|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.101||0.534|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Nausea or vomiting||||0.534
91515093|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.485|STANDARD_ERROR_OF_MEAN|0.157||0.002|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Neuropathy||||0.002
91515094|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.139||0.349|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Skin problems||||0.349
91515095|NCT02897141|182902673|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.107||0.02|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Weight loss or wasting||||0.020
91515096|NCT02897141|182902674|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|7.27||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Physical functioning scale||||0.001
91515097|NCT02897141|182902674|SUPERIORITY|\[Not specified\]|Median Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|10.02||0.458|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to physical health scale||||0.458
91515098|NCT02897141|182902674|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|9.91||0.725|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to emotional problems scale||||0.725
91515099|NCT02897141|182902674|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.09||0.807|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Energy/fatigue scale|\[Not specified\]|||0.807
91515100|NCT02897141|182902674|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|3.73||0.693|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Emotional well-being scale||||0.693
91515101|NCT02897141|182902674|SUPERIORITY||Mean Difference (Final Values)|-8.93|STANDARD_ERROR_OF_MEAN|5.8||0.128|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Social functioning scale||||0.128
91515102|NCT02897141|182902674|SUPERIORITY||Mean Difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|5.18||0.007|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain scale||||0.007
91515103|NCT02897141|182902674|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.93||0.96|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||General health scale||||0.960
91515104|NCT02897141|182902674|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|4.47||0.836|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical health summary scale||||0.836
91515105|NCT02897141|182902674|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|3.6||0.822|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Mental health summary scale||||0.822
91515106|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.25||0.529|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical Function||||0.529
91515107|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|1.71|STANDARD_ERROR_OF_MEAN|1.68||0.312|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.312
91515108|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|1.81||0.841|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.841
91515109|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.07||0.848|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.848
91515110|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.03||0.208|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Sleep Disturbance||||0.208
91515111|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.29||0.754|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Satisfaction with participation in social roles||||0.754
91515112|NCT02897141|182902675|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.66||0.454|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain interference||||0.454
91515113|NCT02897141|182902676|SUPERIORITY||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|2.19||0.252|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||||||0.252
91515114|NCT02897141|182902677|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.62||0.017|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||CASE adherence index||||0.017
91515115|NCT02897141|182902677|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|5.06||0.338|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Visual analogue scale||||0.338
91515116|NCT02897141|182902678|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.743|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Overall||||0.743
91515117|NCT02897141|182902678|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.166|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Quality of life||||0.166
91515118|NCT02897141|182902678|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.899|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived usefulness||||0.899
91515119|NCT02897141|182902678|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.26||0.803|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived ease of use||||0.803
91515120|NCT02897141|182902678|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.48|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||User Control||||0.480
91515121|NCT00156065|182902703|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8619||||||95.0|0.6912|0.9644|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9644|0.6912|
91515122|NCT00156065|182902703|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8834||||||95.0|0.7744|0.955|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9550|0.7744|
91515123|NCT00156065|182902703|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.9376||||||95.0|0.7631|0.9952|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9952|0.7631|
91515124|NCT02395120|182902720|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.05|TWO_SIDED|95.0|1.21|3.08||We addressed the issue of multiple testing, both multiple comparisons and multiple sites, using a gatekeeper approach. The use of 0.05 alpha level for each test maintained a 0.05 family-wise alpha level for the six tests (three at each site).|Regression, Logistic||||The primary outcome analysis utilized generalized estimating equations (GEE) with a logit link for the binary dental care receipt outcome. The GEE analysis was conducted using dental care receipt outcomes as restorative care alone (ICDAS codes ≥3), as well as combined preventive (i.e. sealants) and restorative care (ICDAS codes ≥1). Models were fit separately to the overall data (all sites combined), the combined EC and WA sites (based on our original plan of two predominantly low-income school districts), and the BD schools alone. Each model included, as covariates, indicator variables for intervention, site (except for the model with BD alone), child grade, and caregiver demographic variables (race, education, marital status). Corresponding estimated odds ratios and 95% Confidence Intervals were computed.|3.08|1.21|<0.05
91515125|NCT01997398|182902723|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Differences in baseline and 6-month postoperative scores were assessed using a series of repeated measures general linear models with a single within-subjects factor and no between-subjects factors.|Repeated measures general linear models|||||||<0.001
91515126|NCT02250612|182902740|SUPERIORITY|||||||0.93|||||||ANCOVA|||||||0.93
91515127|NCT02250612|182902740|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
91515128|NCT02250612|182902740|SUPERIORITY|||||||0.23|||||||ANCOVA|||||||0.23
91515129|NCT02250612|182902740|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
91515130|NCT02250612|182902740|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
91515131|NCT02250612|182902740|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
91515132|NCT02250612|182902741|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
91579274|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.29||||||This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.29
91515133|NCT02250612|182902741|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
91515134|NCT02250612|182902741|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
91515135|NCT02250612|182902741|SUPERIORITY|||||||0.412|||||||ANCOVA|||||||0.412
91515136|NCT02250612|182902741|SUPERIORITY|||||||0.79|||||||ANCOVA|||||||0.79
91515137|NCT02250612|182902741|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
91515138|NCT01153633|182902762|SUPERIORITY_OR_OTHER|||||||0.2317||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.2317
91515139|NCT01153633|182902766|SUPERIORITY_OR_OTHER|||||||0.4905||95.0|||||Fisher Exact|||||||0.4905
91515140|NCT01153633|182902767|SUPERIORITY_OR_OTHER|||||||0.9945||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.9945
91515141|NCT00384085|182902768|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.56||||0.0628|TWO_SIDED|95.0|0.97|2.52||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.52|0.97|0.0628
91515142|NCT00384085|182902769|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of Lantus/Apidra-1 would be established if the upper limit of the 2 sided, 99.75% CI for the difference in the mean change from baseline between Lantus/Apidra-1 and Novolog Mix 70/30 was \<0.5%.|Adjusted Mean of difference|-0.34||||0.0359|TWO_SIDED|95.0|-0.82|0.15||The type I error was controlled by performing a 2-tailed comparison at a p=0.0025 level for noninferiority testing.|Mixed Models Analysis|||||0.15|-0.82|0.0359
91515143|NCT00384085|182902770|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.66||||0.0313|TWO_SIDED|95.0|1.04|2.64||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.64|1.04|0.0313
91515144|NCT00384085|182902771|SUPERIORITY_OR_OTHER||Adjusted Mean of difference|-0.31||||0.0565|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||||0.01|-0.63|0.0565
91515145|NCT00384085|182902772|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.79||||0.014|TWO_SIDED|95.0|1.12|2.85|||Regression, Logistic|||||2.85|1.12|0.0140
91515146|NCT00384085|182902773|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.02||||0.9268|TWO_SIDED|95.0|0.61|1.71|||Regression, Logistic|||||1.71|0.61|0.9268
91515147|NCT00384085|182902773|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.11||||0.0107|TWO_SIDED|95.0|1.19|3.73|||Regression, Logistic|||||3.73|1.19|0.0107
91515148|NCT00384085|182902773|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.06||||0.0121|TWO_SIDED|95.0|1.17|3.61|||Regression, Logistic|||||3.61|1.17|0.0121
91515149|NCT05912400|182902776|OTHER||||||<|0.01||||||Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).|Spearman's Rho|||||||<0.01
91515150|NCT05912400|182902776|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
91515151|NCT05912400|182902776|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
91515152|NCT05912400|182902776|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index)||||||0.88
91515153|NCT05912400|182902776|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
91515154|NCT05912400|182902777|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation btwn ECAR (Extracellular Acidification Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain)||||||0.54
91515155|NCT05912400|182902777|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
91515156|NCT05912400|182902777|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
91515157|NCT05912400|182902777|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
91515158|NCT05912400|182902777|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
91515159|NCT05912400|182902778|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
91515160|NCT05912400|182902778|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
91515161|NCT05912400|182902779|OTHER||||||<|0.01|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||<0.01
91515162|NCT05912400|182902779|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||0.54
91515163|NCT05912400|182902780|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
91515164|NCT05912400|182902780|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
91515165|NCT05912400|182902781|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
91515166|NCT05912400|182902781|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
91515167|NCT05912400|182902782|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.88
91515168|NCT05912400|182902782|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
91515169|NCT01944631|182902788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.613|STANDARD_ERROR_OF_MEAN|0.359||0.0895|TWO_SIDED|95.0|-1.321|0.095|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.095|-1.321|0.0895
91515170|NCT01944631|182902789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.146||0.231|TWO_SIDED|95.0|-0.464|0.113|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.113|-0.464|0.2310
91515171|NCT01944631|182902790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.443|STANDARD_ERROR_OF_MEAN|0.304||0.1465|TWO_SIDED|95.0|-1.042|0.156|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.156|-1.042|0.1465
91515172|NCT01944631|182902791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.728|STANDARD_ERROR_OF_MEAN|3.102||0.8148|TWO_SIDED|95.0|-5.39|6.845|||ANCOVA||Difference calculated as bisolviral minus placebo|||6.845|-5.390|0.8148
91515173|NCT01944631|182902792|SUPERIORITY_OR_OTHER|||||||0.1887|TWO_SIDED||||||Log Rank|Log-rank test stratifying for the variable 'baseline TSS'||||||0.1887
91515174|NCT01944631|182902793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1069||||0.6954|TWO_SIDED|95.0|0.666|1.84|||Regression, Logistic||A value greater than one favours bisolviral|||1.840|0.666|0.6954
91515175|NCT04389762|182902802|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
91515176|NCT04389762|182902803|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
91515177|NCT04389762|182902804|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
91515178|NCT04389762|182902805|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.040
91515179|NCT04389762|182902806|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
91515180|NCT04389762|182902807|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
91515181|NCT04389762|182902808|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
91515182|NCT02605954|182902823|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.|Difference in Percentages|-4.4||||0.15|TWO_SIDED|95.0|-9.4|1.9|||Fisher Exact|||||1.9|-9.4|0.15
91515183|NCT02605954|182902824|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.|Difference in Percentages|-3.8||||0.17|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|0.17
91515184|NCT02605954|182902826|OTHER||Difference in least square mean|-36.0||||0.11|TWO_SIDED|95.0|-80.0|9.0|||ANOVA|||||9|-80|0.11
91515185|NCT03214367|182902861|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|-0.08||||0.06|TWO_SIDED|95.0|-0.16|0.0|||Mixed Models Analysis|||||0.00|-0.16|0.060
91515186|NCT03214367|182902861|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.13||||0.003|TWO_SIDED|95.0|0.04|0.22|||Mixed Models Analysis|||||0.22|0.04|0.003
91515187|NCT03214367|182902862|SUPERIORITY||LS Mean Difference|-27.9|||<|0.001|TWO_SIDED|95.0|-35.3|-20.6|||ANCOVA|||||-20.6|-35.3|<0.001
91515188|NCT03214367|182902862|SUPERIORITY||LS Mean Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||ANCOVA|||||21.4|5.0|0.002
91515189|NCT03214367|182902863|SUPERIORITY||LS Mean Difference|-31.2|||<|0.001|TWO_SIDED|95.0|-41.1|-21.2|||ANCOVA|||||-21.2|-41.1|<0.001
91515190|NCT03214367|182902863|SUPERIORITY||LS Mean Difference|-6.7||||0.235|TWO_SIDED|95.0|-17.6|4.3|||ANCOVA|||||4.3|-17.6|0.235
91515191|NCT03214367|182902872|SUPERIORITY||LS Mean Difference|-0.06||||0.184|TWO_SIDED|95.0|-0.16|0.03|||Mixed Models Analysis|||||0.03|-0.16|0.184
91515192|NCT03740490|182902874|SUPERIORITY||Mean Difference (Net)|-0.1||||0.284|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis|||Each outcome was modeled using a mixed-effects regression with the change score as the dependent variable and treatment group (Smart-T vs. QuitGuide) as the predictor, restricted to participants who received or would have received that type of message.||0.08|-0.28|0.284
91515193|NCT03740490|182902875|SUPERIORITY||Mean Difference (Net)|0.06||||0.477|TWO_SIDED|95.0|-0.11|0.24|||Mixed Models Analysis|||||0.24|-0.11|0.477
91515194|NCT03740490|182902876|SUPERIORITY||Mean Difference (Net)|0.03||||0.456|TWO_SIDED|95.0|-0.05|0.1|||Mixed Models Analysis|||||0.10|-0.05|0.456
91515195|NCT03740490|182902877|SUPERIORITY||Mean Difference (Net)|-0.22||||0.215|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.215
91515196|NCT00320216|182902962|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi square test|Stratified by baseline weight \[\<=90kg vs \> 90 kg\].||||||<0.001
91515197|NCT00320216|182902962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91515198|NCT00320216|182902962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91515199|NCT00320216|182902962|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis:No difference between any ustekinumab group and placebo at an overall significant level of 0.05. Sample Size: With 300 participants (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in primary endpoint between ustekinumab groups and placebo using a CMH test with stratification by baseline weight \[≤ 90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.01
91515200|NCT00320216|182902963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91515201|NCT00320216|182902963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
91515202|NCT00320216|182902963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|||||||<0.001
91515203|NCT00320216|182902963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between any ustekinumab group and placebo.||||<0.001
91515204|NCT01949480|182902994|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.643|||||||t-test, 2 sided|||||||0.643
91515205|NCT01949480|182902996|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.077|||||||t-test, 2 sided|||This p-value is calculated for the NRS at rest.||||.077
91515206|NCT01949480|182902996|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.39|||||||t-test, 2 sided|||This p-value is calculated for the NRS during deep inspiration at 24 hrs.||||0.39
91515207|NCT01949480|182902997|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.605|||||||t-test, 2 sided|||||||0.605
91515208|NCT01949480|182902998|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.104|||||||t-test, 2 sided|||This p-value is for the Local Anesthetic infused in 24 hrs.||||0.104
91515209|NCT01949480|182902999|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.308|||||||t-test, 2 sided|||||||0.308
91515210|NCT01949480|182903000|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.487|||||||t-test, 2 sided|||||||0.487
91515211|NCT01949480|182903001|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.493|||||||t-test, 2 sided|||||||0.493
91515212|NCT01949480|182903002|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.574|||||||t-test, 2 sided|||||||0.574
91515213|NCT01949480|182903003|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.913|||||||t-test, 2 sided|||||||0.913
91515214|NCT01949480|182903004|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.783|||||||t-test, 2 sided|||||||0.783
91515215|NCT00144339|182903006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.0||0.9524||95.0|-4.0|4.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-4|0.9524
91515216|NCT00144339|182903007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.2074||95.0|-2.0|6.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||6|-2|0.2074
91515217|NCT00144339|182903008|SUPERIORITY_OR_OTHER|||||||0.2488||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2488
91515218|NCT00144339|182903009|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.0145
91515219|NCT00144339|182903010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.0||0.299||95.0|-12.0|4.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-12|0.2990
91515220|NCT00144339|182903011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.8375||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.8375
91515221|NCT00144339|182903012|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|4.0||0.1143||95.0|-14.0|2.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||2|-14|0.1143
91515222|NCT00144339|182903013|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.787||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.7870
91515223|NCT00144339|182903014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.784||95.0|-0.2|0.3|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||0.3|-0.2|0.7840
91515224|NCT00144339|182903015|SUPERIORITY_OR_OTHER|||||||0.2705||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2705
91515225|NCT00144339|182903016|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.306
91515226|NCT00144339|182903017|SUPERIORITY_OR_OTHER|||||||0.8103||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.8103
91515227|NCT00144339|182903018|SUPERIORITY_OR_OTHER|||||||0.9814||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.9814
91515228|NCT00144339|182903019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||Log Rank|Cox regression with treatment|Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo|Cox regression||0.91|0.81|<0.0001
91515229|NCT00144339|182903020|SUPERIORITY_OR_OTHER||Rate Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||t-test, 2 sided||Ratio calculated as estimated number of events in tio/number of events in placebo|Poisson regression adjusted for overdispersion and treatment exposure||0.91|0.81|<0.0001
91515230|NCT00144339|182903021|SUPERIORITY_OR_OTHER|||||||0.3481||95.0|||||Fisher Exact|||||||0.3481
91515231|NCT00144339|182903022|SUPERIORITY_OR_OTHER||Rate Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0011||95.0|0.83|0.95|||t-test, 2 sided||Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|Poisson regression adjusted for overdispersion and treatment exposure||0.95|0.83|0.0011
91515232|NCT00144339|182903023|SUPERIORITY_OR_OTHER|||||||0.1766||95.0|||||Fisher Exact|||||||0.1766
91515233|NCT00144339|182903024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.04||0.0024||95.0|0.78|0.95|||Log Rank||Hazard ratio shown as tiotropium bromide vs. placebo|Cox regression||0.95|0.78|0.0024
91515234|NCT00144339|182903025|SUPERIORITY_OR_OTHER||Rate ratio|0.94|STANDARD_ERROR_OF_MEAN|0.06||0.3413||95.0|0.82|1.07|||t-test, 2 sided||Ratio of estimated number of events between tiotropium bromide and placebo|||1.07|0.82|0.3413
91515235|NCT00144339|182903026|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.8624||95.0|0.87|1.18|||t-test, 2 sided||Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo|Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.||1.18|0.87|0.8624
91515236|NCT00144339|182903027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|||<|0.0001||95.0|0.077|0.098|||ANOVA|Repeated measures ANOVA||||0.098|0.077|<.0001
91515237|NCT00144339|182903028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|||<|0.0001||95.0|0.037|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.037|<.0001
91515238|NCT00144339|182903029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.087|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.087|<.0001
91515239|NCT00144339|182903030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|||<|0.0001||95.0|0.047|0.069|||ANOVA|Repeated measures ANOVA||||0.069|0.047|<.0001
91515240|NCT00144339|182903031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|||<|0.0001||95.0|0.091|0.115|||ANOVA|Repeated measures ANOVA||||0.115|0.091|<.0001
91515241|NCT00144339|182903032|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.054|||<|0.0001||95.0|0.042|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.042|<.0001
91515242|NCT00144339|182903033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|||<|0.0001||95.0|0.078|0.104|||ANOVA|Repeated measures ANOVA||||0.104|0.078|<.0001
91515243|NCT00144339|182903034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|||<|0.0001||95.0|0.04|0.066|||ANOVA|Repeated measures ANOVA||||0.066|0.040|<.0001
91515244|NCT00144339|182903035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.0001||95.0|0.081|0.107|||ANOVA|Repeated measures ANOVA||||0.107|0.081|<.0001
91515245|NCT00144339|182903036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|||<|0.0001||95.0|0.049|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.049|<.0001
91515246|NCT00144339|182903037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.081|0.109|||ANOVA|Repeated measures ANOVA||||0.109|0.081|<.0001
91515247|NCT00144339|182903038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.047|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.047|<.0001
91515248|NCT00144339|182903039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.085|0.114|||ANOVA|Repeated measures ANOVA||||0.114|0.085|<.0001
91515249|NCT00144339|182903040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.051|0.08|||ANOVA|Repeated measures ANOVA||||0.080|0.051|<.0001
91515250|NCT00144339|182903041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.08|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.080|<.0001
91515251|NCT00144339|182903042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.045|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.045|<.0001
91515252|NCT00144339|182903043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.0001||95.0|0.073|0.103|||ANOVA|Repeated measures ANOVA||||0.103|0.073|<.0001
91515253|NCT00144339|182903044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||<|0.0001||95.0|0.033|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.033|<.0001
91515254|NCT00144339|182903045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001||95.0|0.168|0.211|||ANOVA|Repeated measures ANOVA||||0.211|0.168|<.0001
91515255|NCT00144339|182903046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.037|0.073|||ANOVA|Repeated measures ANOVA||||0.073|0.037|<.0001
91515256|NCT00144339|182903047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|||<|0.0001||95.0|0.18|0.228|||ANOVA|Repeated measures ANOVA||||0.228|0.180|<.0001
91515257|NCT00144339|182903048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.034|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.034|<.0001
91515258|NCT00144339|182903049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.0001||95.0|0.173|0.222|||ANOVA|Repeated measures ANOVA||||0.222|0.173|<.0001
91515259|NCT00144339|182903050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||<|0.0001||95.0|0.026|0.07|||ANOVA|Repeated measures ANOVA||||0.070|0.026|<.0001
91515260|NCT00144339|182903051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|||<|0.0001||95.0|0.167|0.221|||ANOVA|Repeated measures ANOVA||||0.221|0.167|<.0001
91515261|NCT00144339|182903052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.0001||95.0|0.026|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.026|<.0001
91515262|NCT00144339|182903053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|||<|0.0001||95.0|0.161|0.216|||ANOVA|Repeated measures ANOVA||||0.216|0.161|<.0001
91515263|NCT00144339|182903054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|||<|0.0001||95.0|0.035|0.084|||ANOVA|Repeated measures ANOVA||||0.084|0.035|<.0001
91515264|NCT00144339|182903055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|||<|0.0001||95.0|0.157|0.213|||ANOVA|Repeated measures ANOVA||||0.213|0.157|<.0001
91515265|NCT00144339|182903056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0005||95.0|0.021|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.021|0.0005
91515266|NCT00144339|182903057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.0001||95.0|0.17|0.229|||ANOVA|Repeated measures ANOVA||||0.229|0.170|<.0001
91515267|NCT00144339|182903058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.038|0.093|||ANOVA|Repeated measures ANOVA||||0.093|0.038|<.0001
91515268|NCT00144339|182903059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|||<|0.0001||95.0|0.154|0.215|||ANOVA|Repeated measures ANOVA||||0.215|0.154|<.0001
91515269|NCT00144339|182903060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.002||95.0|0.017|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.017|0.0020
91515270|NCT00144339|182903061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.139|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.139|<.0001
91515271|NCT00144339|182903062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0365||95.0|0.002|0.061|||ANOVA|Repeated measures ANOVA||||0.061|0.002|0.0365
91515272|NCT00144339|182903063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.147|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.147|<.0001
91515273|NCT00144339|182903064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.0002||95.0|0.018|0.058|||ANOVA|Repeated measures ANOVA||||0.058|0.018|0.0002
91515274|NCT00144339|182903065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.0001||95.0|0.161|0.21|||ANOVA|Repeated measures ANOVA||||0.210|0.161|<.0001
91515275|NCT00144339|182903066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0018||95.0|0.014|0.06|||ANOVA|Repeated measures ANOVA||||0.060|0.014|0.0018
91515276|NCT00144339|182903067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|||<|0.0001||95.0|0.151|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.151|<.0001
91515277|NCT00144339|182903068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0069||95.0|0.009|0.055|||ANOVA|Repeated measures ANOVA||||0.055|0.009|0.0069
91515278|NCT00144339|182903069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.127|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.127|<.0001
91515279|NCT00144339|182903070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.002||95.0|0.015|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.015|0.0020
91515280|NCT00144339|182903071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||<|0.0001||95.0|0.139|0.194|||ANOVA|Repeated measures ANOVA||||0.194|0.139|<.0001
91515281|NCT00144339|182903072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0165||95.0|0.006|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.006|0.0165
91515282|NCT00144339|182903073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.141|0.199|||ANOVA|Repeated measures ANOVA||||0.199|0.141|<.0001
91515283|NCT00144339|182903074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.0248||95.0|0.004|0.059|||ANOVA|Repeated measures ANOVA||||0.059|0.004|0.0248
91515284|NCT00144339|182903075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|||<|0.0001||95.0|0.136|0.196|||ANOVA|Repeated measures ANOVA||||0.196|0.136|<.0001
91515285|NCT00144339|182903076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.0004||95.0|0.022|0.078|||ANOVA|Repeated measures ANOVA||||0.078|0.022|0.0004
91515286|NCT00144339|182903077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||<|0.0001||95.0|0.13|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.130|<.0001
91515287|NCT00144339|182903078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.0809||95.0|-0.003|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.003|0.0809
91515288|NCT00144339|182903079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.0001||95.0|0.119|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.119|<.0001
91515289|NCT00144339|182903080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.0915||95.0|-0.004|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.004|0.0915
91515290|NCT00144339|182903081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.0001||95.0|-3.535|-2.226|||ANOVA|Repeated measures ANOVA||||-2.226|-3.535|<.0001
91515291|NCT00144339|182903082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.771|||<|0.0001||95.0|-3.461|-2.081|||ANOVA|Repeated measures ANOVA||||-2.081|-3.461|<.0001
91515292|NCT00144339|182903083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.593|||<|0.0001||95.0|-3.352|-1.834|||ANOVA|Repeated measures ANOVA||||-1.834|-3.352|<.0001
91515293|NCT00144339|182903084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.384|||<|0.0001||95.0|-3.191|-1.576|||ANOVA|Repeated measures ANOVA||||-1.576|-3.191|<.0001
91515294|NCT00144339|182903085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.423|||<|0.0001||95.0|-3.277|-1.569|||ANOVA|Repeated measures ANOVA||||-1.569|-3.277|<.0001
91515295|NCT00144339|182903086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.345|||<|0.0001||95.0|-4.229|-2.462|||ANOVA|Repeated measures ANOVA||||-2.462|-4.229|<.0001
91515296|NCT00144339|182903087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.818|||<|0.0001||95.0|-3.742|-1.894|||ANOVA|Repeated measures ANOVA||||-1.894|-3.742|<.0001
91515297|NCT00144339|182903088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.303|||<|0.0001||95.0|-3.266|-1.34|||ANOVA|Repeated measures ANOVA||||-1.340|-3.266|<.0001
91515298|NCT00144339|182903089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.06||0.0242||95.0|0.74|0.98|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||0.98|0.74|0.0242
91515299|NCT00144339|182903090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.06||0.0339||95.0|0.76|0.99|||Log Rank||Cox regression; cut-off at 4 years ; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|Hazard ratio of all cause mortality vital status was information followed-up after discontinuation; vital status information up to 1440 days after the start of treatment was used||0.99|0.76|0.0339
91515300|NCT00144339|182903091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|STANDARD_ERROR_OF_MEAN|0.06||0.0859||95.0|0.79|1.02|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|||1.02|0.79|0.0859
91515301|NCT00144339|182903092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1936||95.0|0.67|1.08|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||1.08|0.67|0.1936
91515302|NCT00144339|182903093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2377||95.0|0.71|1.09|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo|||1.09|0.71|0.2377
91515303|NCT00144339|182903094|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.029||95.0|0.73|0.98|||Z-test|incidence rate = number of patients with event/ time at risk|Rate ratio of incidence rates (tiotropium/placebo)|||0.98|0.73|0.0290
91515304|NCT00144339|182903095|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.44||||0.1158||95.0|0.91|2.26|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||2.26|0.91|0.1158
91515305|NCT00144339|182903096|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.7725||95.0|0.68|1.33|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.33|0.68|0.7725
91515306|NCT00144339|182903097|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.25||||0.2666||95.0|0.84|1.87|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.87|0.84|0.2666
91515307|NCT00144339|182903098|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.59||||0.0337||95.0|0.37|0.96|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.96|0.37|0.0337
91515308|NCT00144339|182903099|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.58||||0.0537||95.0|0.33|1.01|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.01|0.33|0.0537
91515309|NCT00144339|182903100|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.71||||0.0403||95.0|0.52|0.99|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.99|0.52|0.0403
91515310|NCT00144339|182903101|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0001||95.0|0.77|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.77|0.0001
91515311|NCT00144339|182903102|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.2||||0.4789||95.0|0.73|1.98|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.98|0.73|0.4789
91515312|NCT00144339|182903103|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0014||95.0|0.76|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.76|0.0014
91515313|NCT00144339|182903104|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.61||||0.0236||95.0|0.4|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.40|0.0236
91515314|NCT00144339|182903105|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.5064||95.0|0.81|1.11|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.11|0.81|0.5064
91515315|NCT00144339|182903106|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.69||||0.0104||95.0|0.52|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.52|0.0104
91515316|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-1.42|1.12|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.12|-1.42|
91515317|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.93|0.17|||||Total effect of zanamivir prophylaxis|||0.17|-0.93|
91515318|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-0.75|0.47|||||Direct effect of zanamivir prophylaxis when index is treated|||0.47|-0.75|
91515319|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.23|||||TWO_SIDED|95.0|-1.15|1.62|||||Risk in cohort 1 minus risk in cohort 2|||1.62|-1.15|
91515320|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.51|0.03|||||Protective effect of zanamivir on susceptible risk|||0.03|-0.51|
91515321|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.01|0.99|
91515322|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
91515323|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
91515324|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|0.99|
91515325|NCT01156701|182903158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
91515326|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.17|0.36|||||Direct effect of Zanamivir prophylaxis on asthma risk|||0.36|-1.17|
91515327|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.8|0.03|||||Total effect of zanamivir prophylaxis|||0.03|-0.80|
91515328|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.28|||||TWO_SIDED|95.0|-0.75|0.18|||||Direct effect of zanamivir prophylaxis when index is treated|||0.18|-0.75|
91515329|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.89|0.85|||||Risk in cohort 1 minus risk in cohort 2|||0.85|-0.89|
91515330|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.31|0.11|||||Protective effect of zanamivir on susceptible risk|||0.11|-0.31|
91515331|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of Zanamivir prophylaxis on asthma risk|||1.00|0.99|
91515332|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
91515333|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
91515334|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Risk in cohort 1 minus risk in cohort 2|||1.01|0.99|
91515335|NCT01156701|182903159|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
91515336|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.46|||||TWO_SIDED|95.0|-0.61|1.54|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.54|-0.61|
91515337|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.45|-0.04|||||Total effect of zanamivir prophylaxis|||-0.04|-0.45|
91515338|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.39|0.09|||||Direct effect of zanamivir prophylaxis when index is treated|||0.09|-0.39|
91515339|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.72|||||TWO_SIDED|95.0|-0.38|1.81|||||Risk in cohort 1 minus risk in cohort 2|||1.81|-0.38|
91515340|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.22|0.02|||||Protective effect of zanamivir on susceptible risk|||0.02|-0.22|
91515341|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.02|0.99|
91515342|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Total effect of zanamivir prophylaxis|||1.00|1.00|
91515343|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|1.00|
91515344|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|1.00|
91515345|NCT01156701|182903160|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
91515346|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-0.83|3.4|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||3.40|-0.83|
91515347|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.98|0.47|||||Total effect of zanamivir prophylaxis|||0.47|-0.98|
91515348|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.85|0.67|||||Direct effect of zanamivir prophylaxis when index is treated|||0.67|-0.85|
91515349|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.53|||||TWO_SIDED|95.0|-0.7|3.76|||||Risk in cohort 1 minus risk in cohort 2|||3.76|-0.70|
91515350|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-0.44|0.12|||||Protective effect of zanamivir on susceptible risk|||0.12|-0.44|
91515351|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||1.03|0.99|
91579275|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
91515352|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
91515353|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of zanamivir prophylaxis when index is treated|||1.01|0.99|
91515354|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.99|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.99|
91515355|NCT01156701|182903161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
91515356|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-3.08|2.79|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||2.79|-3.08|
91515357|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.07|||||TWO_SIDED|95.0|-2.39|0.25|||||Total effect of zanamivir prophylaxis|||0.25|-2.39|
91515358|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.08|||||TWO_SIDED|95.0|-2.51|0.35|||||Direct effect of zanamivir prophylaxis when index is treated|||0.35|-2.51|
91515359|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-2.29|4.14|||||Risk in cohort 1 minus risk in cohort 2|||4.14|-2.29|
91515360|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.58|0.59|||||Protective effect of zanamivir on susceptible risk|||0.59|-0.58|
91515361|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.03|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||1.03|0.97|
91515362|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.98|
91515363|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.98|
91515364|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.98|
91515365|NCT01156701|182903162|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
91515366|NCT02232893|182903173|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
91515367|NCT01764945|182903174|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.58|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|73.69|92.54|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||92.54|73.69|
91515368|NCT01764945|182903174|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.34|STANDARD_DEVIATION|22.2|||TWO_SIDED|90.0|73.65|94.3|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||94.30|73.65|
91515369|NCT01764945|182903174|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.92|STANDARD_DEVIATION|19.6|||TWO_SIDED|90.0|74.69|94.28|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||94.28|74.69|
91515370|NCT01764945|182903174|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.9|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|88.94|97.04|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||97.04|88.94|
91579276|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.08||||||This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.08
91515371|NCT01764945|182903174|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|96.37|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|91.55|101.43|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||101.43|91.55|
91515372|NCT01764945|182903174|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.44|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.88|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||99.24|89.88|
91515373|NCT01764945|182903175|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|74.07|STANDARD_DEVIATION|21.5|||TWO_SIDED|90.0|65.44|83.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||83.83|65.44|
91515374|NCT01764945|182903175|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|73.23|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|63.33|84.68|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||84.68|63.33|
91515375|NCT01764945|182903175|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.76|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|68.94|89.99|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||89.99|68.94|
91515376|NCT01764945|182903175|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.3|STANDARD_DEVIATION|22.5|||TWO_SIDED|90.0|71.42|85.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||85.84|71.42|
91515377|NCT01764945|182903175|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.43|STANDARD_DEVIATION|30.4|||TWO_SIDED|90.0|69.54|88.46|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||88.46|69.54|
91515378|NCT01764945|182903175|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.09|STANDARD_DEVIATION|29.4|||TWO_SIDED|90.0|69.35|87.94|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||87.94|69.35|
91515379|NCT01764945|182903176|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.02|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|75.98|88.55|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||88.55|75.98|
91515380|NCT01764945|182903176|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|80.93|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|74.58|87.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||87.83|74.58|
91515381|NCT01764945|182903176|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|79.6|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|74.84|84.67|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||84.67|74.84|
91515382|NCT01764945|182903176|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|91.59|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|87.53|95.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||95.84|87.53|
91515383|NCT01764945|182903176|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.38|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|89.76|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||99.24|89.76|
91515384|NCT01764945|182903176|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.91|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|88.42|97.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||97.63|88.42|
91515385|NCT02911948|182903190|SUPERIORITY|Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.0% for null hypothesis (H0): D=0.0% against the alternative (HA): D≠0.0%, where D is the mean difference (IDegLira - IDeg).|Treatment contrast|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.06|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment and pre-trial anti-diabetic treatment as fixed factors and corresponding baseline HbA1c value as covariate.||-1.06|-1.50|<0.0001
91515386|NCT02854540|182903219|OTHER||Mean difference (percent)|59.0|STANDARD_DEVIATION|16.0|||TWO_SIDED|||||||||||||
91515387|NCT03819660|182903250|OTHER||percentage|38.5|||||TWO_SIDED|||||||||||||
91515388|NCT01136291|182903252|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The homogeneity between the groups was compared by the Student's t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student's t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.||||<0.05
91515389|NCT03965052|182903255|OTHER|||||||1|||||||Fisher Exact|||||||1.000
91515390|NCT03965052|182903257|OTHER|||||||1|||||||Fisher Exact|||Lissamine green treatment groups||||1.000
91515391|NCT03965052|182903257|OTHER|||||||0.667|||||||Fisher Exact|||Fluorescein treatment groups||||0.667
91515392|NCT03965052|182903258|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
91515393|NCT03965052|182903259|OTHER|||||||0.977|||||||Chi-squared, Corrected|||the analysis was per protocol||||0.977
91515394|NCT03965052|182903261|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
91515395|NCT02308033|182903292|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
91515396|NCT02308033|182903293|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
91515397|NCT02308033|182903294|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of normal Nugent scores at 7-14 days||||<0.001
91515398|NCT02308033|182903295|SUPERIORITY|||||||0.034|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.034
91515399|NCT04773015|182903303|OTHER|||||||0.6371|||||||Fisher Exact|||||||0.6371
91515400|NCT04773015|182903304|OTHER|||||||0.1448|||||||Fisher Exact|||||||0.1448
91515401|NCT04773015|182903305|OTHER|||||||0.1507|||||||Fisher Exact|||||||0.1507
91515402|NCT04773015|182903306|OTHER|||||||0.1189|||||||Fisher Exact|||||||0.1189
91515403|NCT04964089|182903308|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.91||0.0083|TWO_SIDED|95.03|-3.88|-0.29|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA as covariates.||||-0.29|-3.88|0.0083
91515404|NCT01221597|182903338|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANOVA|||||||0.0005
91515405|NCT01221597|182903339|SUPERIORITY_OR_OTHER|||||||0.0451|TWO_SIDED||||||ANOVA|||||||0.0451
91515406|NCT01221597|182903340|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
91515407|NCT01221597|182903341|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||ANOVA|||||||0.0268
91515408|NCT01221597|182903342|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||||||0.0800
91515409|NCT01221597|182903343|SUPERIORITY_OR_OTHER|||||||0.3085|TWO_SIDED||||||ANOVA|||||||0.3085
91515410|NCT01221597|182903344|SUPERIORITY_OR_OTHER|||||||0.6321|TWO_SIDED||||||ANOVA|||||||0.6321
91515411|NCT01221597|182903345|SUPERIORITY_OR_OTHER|||||||0.7965|TWO_SIDED||||||ANOVA|||||||0.7965
91515412|NCT01221597|182903346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
91515413|NCT04153409|182903350|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Statistical comparisons of the 7 mean changes from baseline to different time-points (0-24 hours) were undertaken in one mixed effects model of analysis taking into account the cross-over nature of the study and the multiple time points within each period to explore a possible treatment effect in this small proof of concept study. Change from baseline at 0.5 hours is presented in this section|Mean Difference (Net)|-0.02||||0.9733|TWO_SIDED|95.0|-1.23|1.19||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 0.5 hours||1.19|-1.23|0.9733
91515414|NCT04153409|182903350|SUPERIORITY||Mean Difference (Net)|-0.42||||0.4942|TWO_SIDED|95.0|-1.64|0.79||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1 hour. The change from baseline at 1 hour was extracted from the mixed model analysis including all time points.||0.79|-1.64|0.4942
91515415|NCT04153409|182903350|SUPERIORITY||Mean Difference (Net)|-0.25||||0.6866|TWO_SIDED|95.0|-1.46|0.97||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1.5 hours. The change from baseline at 1.5 hours was extracted from the mixed model analysis including all time points.||0.97|-1.46|0.6866
91515416|NCT04153409|182903350|SUPERIORITY||Mean Difference (Net)|-0.89||||0.1488|TWO_SIDED|95.0|-2.11|0.32||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 2 hours. The change from baseline at 2 hours was extracted from the mixed model analysis including all time points.||0.32|-2.11|0.1488
91515417|NCT04153409|182903350|SUPERIORITY||Mean Difference (Net)|-0.36||||0.5644|TWO_SIDED|95.0|-1.57|0.86||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 4 hours. The change from baseline at 4 hours was extracted from the mixed model analysis including all time points.||0.86|-1.57|0.5644
91515418|NCT04153409|182903350|SUPERIORITY||Mean Difference (Net)|-0.7||||0.2561|TWO_SIDED|95.0|-1.91|0.51||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 8 hours, The change from baseline at 8 hours was extracted from the mixed model analysis including all time points.||0.51|-1.91|0.2561
91515419|NCT04153409|182903350|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9875|TWO_SIDED|95.0|-1.22|1.2||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 24 hours. The change from baseline at 24 hours was extracted from the mixed model analysis including all time points.||1.20|-1.22|0.9875
91515420|NCT00148343|182903354|SUPERIORITY_OR_OTHER||Slope|1.26|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-0.2|2.75|||||Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks|||2.75|-0.2|
91515421|NCT00148343|182903355|SUPERIORITY||Slope|-5.07|STANDARD_ERROR_OF_MEAN|2.54|<|0.05|TWO_SIDED|95.0|-10.05|-0.09|||Mixed Models Analysis||Slope is in reference to from baseline to end of follow-up at 36 weeks.|||-0.09|-10.05|<0.05
91515422|NCT00148343|182903356|SUPERIORITY_OR_OTHER||Slope|0.31|STANDARD_ERROR_OF_MEAN|7.35|<|0.05|TWO_SIDED|95.0|-14.096|14.716|||Mixed Models Analysis||Slope is in reference to start of treatment to end of follow up at 36 weeks|||14.716|-14.096|<0.05
91515423|NCT00148343|182903357|SUPERIORITY||Slope|-1.95|STANDARD_ERROR_OF_MEAN|5.53|||TWO_SIDED|95.0|-12.79|8.89|||||Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks|||8.89|-12.79|
91515424|NCT00148343|182903358|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|-0.045|0.057|||Mixed Models Analysis||Slope is in reference to baseline to end of follow-up at 36 weeks|||0.057|-0.045|<0.05
91515425|NCT00574587|182903364|SUPERIORITY_OR_OTHER_LEGACY||95% Confidence interval|54.0|||<|0.1|TWO_SIDED|20.0|34.0|74.0|||Simon's Mimimax 2-stage design|||||74|34|<0.10
91515426|NCT00121238|182903396|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
91515427|NCT01380327|182903400|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).|Analysis compared cockroach SLIT -high dose, Placebo - high dose||2.3|1.2|0.001
91515428|NCT01380327|182903400|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.7|3.1|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).|Analysis compared cockroach SLIT - low dose, placebo - low dose||3.1|1.7|<0.0001
91515429|NCT01380327|182903401|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||<|0.0001|TWO_SIDED|95.0|1.1|1.4|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).|Analysis compared cockroach SLIT - high dose, placebo - high dose||1.4|1.1|<0.0001
91515430|NCT01380327|182903401|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.11|TWO_SIDED|95.0|1.0|1.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).|Analysis compared cockroach SLIT - low dose, placebo - low dose||1.2|1.0|0.11
91515431|NCT01380327|182903402|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.06|TWO_SIDED|95.0|1.0|2.4|||Mixed Models Analysis||Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).|Analysis compared cockroach SLIT - high dose, placebo - high dose||2.4|1.0|0.06
91515432|NCT01380327|182903402|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.4||||0.13|TWO_SIDED|95.0|0.9|2.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).|Analysis compared cockroach SLIT - low dose, placebo - low dose||2.2|0.9|0.13
91515433|NCT01380327|182903403|SUPERIORITY_OR_OTHER||Treatment effect|-12.9||||0.21|TWO_SIDED|95.0|-33.2|7.5|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - high dose, placebo - high dose||7.5|-33.2|0.21
91515434|NCT01380327|182903403|SUPERIORITY_OR_OTHER||Treatment effect|13.5||||0.2|TWO_SIDED|95.0|-7.1|34.1|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - low dose, placebo - low dose||34.1|-7.1|0.20
91515435|NCT03732209|182903418|SUPERIORITY||F value, group x time interaction|7.155||||0.017|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||Reported values in outcome measures data table reflect mean change in glycosylated hemoglobin for each group (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.017
91515436|NCT03732209|182903419|SUPERIORITY||F value, group x time interaction|4.885||||0.042|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||The values reported in the outcome measures data table reflect mean change in AUC (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.042
91515437|NCT03732209|182903420|SUPERIORITY||F value, group x time interaction|2.33||||0.146|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.146
91515438|NCT03732209|182903421|SUPERIORITY||Median Difference (Final Values)|1.23||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.042
91515439|NCT05046795|182903422|SUPERIORITY||Mean Difference (Net)|150.91|STANDARD_ERROR_OF_MEAN|23.727|<|0.0001|TWO_SIDED|95.0|104.145|197.671|||Mixed Models Analysis|||||197.671|104.145|<0.0001
91515440|NCT05046795|182903423|SUPERIORITY||Mean Difference (Net)|144.35|STANDARD_ERROR_OF_MEAN|21.192|<|0.0001|TWO_SIDED|95.0|102.61|186.088|||Mixed Models Analysis|||||186.088|102.610|<0.0001
91515441|NCT05046795|182903424|SUPERIORITY||Mean Difference (Net)|287.75|STANDARD_ERROR_OF_MEAN|38.473|<|0.0001|TWO_SIDED|95.0|211.933|363.57|||Mixed Models Analysis|||||363.570|211.933|<0.0001
91515442|NCT05046795|182903425|SUPERIORITY||Mean Difference (Net)|105.9|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|72.6|139.12|||ANCOVA|||||139.12|72.60|<0.0001
91515443|NCT05046795|182903426|SUPERIORITY||Mean Difference (Net)|154.8|STANDARD_ERROR_OF_MEAN|28.37|<|0.0001|TWO_SIDED|95.0|98.86|210.78|||ANCOVA|||||210.78|98.86|<0.0001
91515444|NCT05046795|182903427|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|1.8||0.0064|TWO_SIDED|95.0|-8.49|-1.4|||ANCOVA|||||-1.40|-8.49|0.0064
91515445|NCT05046795|182903428|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0144|TWO_SIDED|95.0|1.16|3.84|||Regression, Logistic|||||3.84|1.16|0.0144
91515446|NCT00782340|182903465|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.003
91515447|NCT00782340|182903466|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.||||||0.003
91515448|NCT00782340|182903467|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.010
91515449|NCT00782340|182903468|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.003
91515450|NCT00782340|182903469|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.009
91515451|NCT00782340|182903470|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||<0.001
91515452|NCT00782340|182903471|SUPERIORITY_OR_OTHER|||||||0.327||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.|Fisher Exact|||||||0.327
91515453|NCT01306162|182903476|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|19.9||1|TWO_SIDED|90.0|191.0|240.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation.|150mg DE + 400mg DR same time (TrtB) vs 150mg DE (TrtA)||240|191|1.0000
91515454|NCT01306162|182903476|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|130.0|STANDARD_DEVIATION|25.0||0.6697|TWO_SIDED|90.0|112.0|151.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||151|112|0.6697
91515455|NCT01306162|182903476|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|236.0|STANDARD_DEVIATION|21.8||0.9992||90.0|173.0|321.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||321|173|0.9992
91515456|NCT01306162|182903476|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|162.0|STANDARD_DEVIATION|20.1||0.9171|TWO_SIDED|90.0|119.0|221.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||221|119|0.9171
91515457|NCT01306162|182903477|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|187.0|STANDARD_DEVIATION|24.3||0.9999|TWO_SIDED|90.0|162.0|215.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||215|162|0.9999
91515458|NCT01306162|182903477|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|115.0|STANDARD_DEVIATION|31.2||0.2207|TWO_SIDED|90.0|95.0|138.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||138|95|0.2207
91515459|NCT01306162|182903477|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|225.0|STANDARD_DEVIATION|26.1||0.9946||90.0|156.0|326.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||326|156|0.9946
91515460|NCT01306162|182903477|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|133.0|STANDARD_DEVIATION|23.0||0.6221|TWO_SIDED|90.0|94.0|190.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||190|94|0.6221
91515461|NCT01306162|182903478|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|20.7||1|TWO_SIDED|90.0|190.0|241.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||241|190|1.0000
91515462|NCT01306162|182903478|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|132.0|STANDARD_DEVIATION|26.3||0.7223|TWO_SIDED|90.0|113.0|155.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||155|113|0.7223
91515463|NCT01306162|182903478|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|258.0|STANDARD_DEVIATION|24.6||0.9993||90.0|182.0|365.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||365|182|0.9993
91515464|NCT01306162|182903478|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|159.0|STANDARD_DEVIATION|21.5||0.8875|TWO_SIDED|90.0|114.0|222.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||222|114|0.8875
91515465|NCT01306162|182903479|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|180.0|STANDARD_DEVIATION|24.6||0.9998|TWO_SIDED|90.0|156.0|207.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||207|156|0.9998
91515466|NCT01306162|182903479|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|114.0|STANDARD_DEVIATION|29.4||0.1866|TWO_SIDED|90.0|95.0|136.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||136|95|0.1866
91515467|NCT01306162|182903479|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|234.0|STANDARD_DEVIATION|26.7||0.9958||90.0|160.0|340.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||340|160|0.9958
91515468|NCT01306162|182903479|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|126.0|STANDARD_DEVIATION|22.6||0.5164|TWO_SIDED|90.0|89.0|179.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||179|89|0.5164
91515469|NCT00690755|182903484|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||.001
91515470|NCT02830594|182903570|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.6|||||||Paired t Test|||||||0.60
91515471|NCT02830594|182903571|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.87|||||||Paired t Test|||||||0.87
91515472|NCT02830594|182903572|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.64|||||||Paired t Test|||||||0.64
91515473|NCT01934218|182903577|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.7|2.7|||Basic longitudinal model|||||2.7|-2.7|0.988
91515474|NCT01934218|182903578|OTHER|Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.||||||||||||||||A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.|Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).|||
91515475|NCT02279641|182903632|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|133.0|||||TWO_SIDED|90.0|111.0|159.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||159|111|
91515476|NCT02279641|182903632|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|67.9|||||TWO_SIDED|90.0|65.2|70.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||70.7|65.2|
91515477|NCT02279641|182903634|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|93.3|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|93.3|
91515478|NCT02279641|182903634|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
91515479|NCT02279641|182903634|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|90.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
91515480|NCT02279641|182903635|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|94.9|112.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||112|94.9|
91515481|NCT02279641|182903635|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
91515482|NCT02279641|182903637|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|89.5|||||TWO_SIDED|90.0|81.8|98.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||98.0|81.8|
91515483|NCT02279641|182903637|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|119.0|||||TWO_SIDED|90.0|114.0|125.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||125|114|
91515484|NCT02279641|182903638|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|87.5|||||TWO_SIDED|90.0|79.3|96.6|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||96.6|79.3|
91515485|NCT02279641|182903638|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|193.0|||||TWO_SIDED|90.0|177.0|210.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||210|177|
91515486|NCT02279641|182903638|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|105.0|||||TWO_SIDED|90.0|94.4|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|94.4|
91515487|NCT02279641|182903641|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.7|||||TWO_SIDED|95.0|87.7|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|87.7|
91515488|NCT02279641|182903642|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
91515489|NCT02279641|182903643|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
91515490|NCT02279641|182903644|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|95.0|86.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|86.7|
91515491|NCT01682837|182903645|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
91515492|NCT01682837|182903646|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||0.20
91515493|NCT01682837|182903647|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||||||0.16
91515494|NCT01682837|182903648|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.70
91515495|NCT01682837|182903649|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|||||||0.42
91515496|NCT01682837|182903650|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
91515497|NCT01682837|182903651|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
91515498|NCT01682837|182903652|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
91515499|NCT01682837|182903653|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mixed Models Analysis|||||||0.12
91515500|NCT01664078|182903654|OTHER|The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.||||||0.47|||||||Mixed Models Analysis|||||||0.47
91515501|NCT02877485|182903683|OTHER||Mean Difference (Net)|1.5||||0.7|TWO_SIDED|95.0|-6.0|8.9||"Statistical Tests:~Independent t-test to assess differences in mean change in NOSE scores when comparing the two study groups, and p\<0.05 deemed statistically significant"|t-test, 2 sided||Change in Mean NOSE score from baseline to post saline versus change in NOSE score from baseline to post intranasal steroid.|"1\) H0: mean change in NOSE score from baseline after in study group 1 = mean change in NOSE score from baseline in study group 2~Power calculation: To detect a 20% difference in NOSE scores with 80% power and a 2-sided alpha level of 0.05 required 20 participants per study group, for a total of 40 participants."||8.9|-6.0|0.7
91515502|NCT02877485|182903684|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_DEVIATION|27.6|<|0.001|TWO_SIDED|||||Paired t-tests to assess differences in mean NOSE score when the treatment groups were combined (saline arm+ steroid arm) at five post-operative time intervals compared to the combined preoperative baseline scores. Significance at p\<0.05.|Paired t-test|||H0: Mean pre- treatment baseline patient NOSE score = Mean post- treatment baseline patient NOSE score.||||<0.001
91515503|NCT04369469|182903685|OTHER||Risk Difference (RD)|-0.0205||||0.6059|TWO_SIDED|95.0|-0.1703|0.1293||One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.|Mantel Haenszel||Two-sided 95% confidence interval using the Sato variance estimator, combined overall imputations.|||0.1293|-0.1703|0.6059
91515504|NCT01344460|182903730|SUPERIORITY_OR_OTHER||Percentage difference|18.3|||<|0|TWO_SIDED|95.0|15.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||15.2|<0.000
91515505|NCT01344460|182903730|SUPERIORITY_OR_OTHER||Percentage difference|16.4|||<|0|TWO_SIDED|95.0|13.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.2|<0.000
91515506|NCT01344460|182903730|SUPERIORITY_OR_OTHER||Percentage difference|24.0|||<|0|TWO_SIDED|95.0|20.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.5|<0.000
91515507|NCT01344460|182903730|SUPERIORITY_OR_OTHER||Percentage difference|17.4|||<|0|TWO_SIDED|95.0|14.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.3|<0.000
91515508|NCT01344460|182903730|SUPERIORITY_OR_OTHER||Percentage difference|25.6|||<|0|TWO_SIDED|95.0|21.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||21.9|<0.000
91515509|NCT01344460|182903731|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|6.8|||||TWO_SIDED|95.0|-2.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-2.2|
91515510|NCT01344460|182903731|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|0.0|||||TWO_SIDED|95.0|-9.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-9.7|
91515511|NCT01344460|182903731|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|14.3|||||TWO_SIDED|95.0|5.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||5.1|
91515512|NCT01344460|182903731|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.0|||||TWO_SIDED|95.0|-5.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.8|
91515513|NCT01344460|182903731|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|20.0|||||TWO_SIDED|95.0|11.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.7|
91515514|NCT01344460|182903732|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.0|||||TWO_SIDED|95.0|7.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.0|
91515515|NCT01344460|182903732|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|11.3|||||TWO_SIDED|95.0|9.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||9.1|
91579277|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.61||||||This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.61
91515516|NCT01344460|182903732|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.0|7.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.6|
91515517|NCT01344460|182903732|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.4|||||TWO_SIDED|95.0|11.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.2|
91515518|NCT01344460|182903732|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.1|||||TWO_SIDED|95.0|11.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.0|
91515519|NCT01344460|182903733|SUPERIORITY_OR_OTHER||percentage|54.6|||||ONE_SIDED|95.0|46.2||||One sided 95% confidence interval|||Majority reader|||46.2|
91515520|NCT01344460|182903733|SUPERIORITY_OR_OTHER||percentage|51.6|||||ONE_SIDED|95.0|43.6||||One sided 95% confidence interval|||Blinded Reader 1|||43.6|
91515521|NCT01344460|182903733|SUPERIORITY_OR_OTHER||percentage|54.4|||||ONE_SIDED|95.0|45.5||||One sided 95% confidence interval|||Blinded Reader 2|||45.5|
91515522|NCT01344460|182903733|SUPERIORITY_OR_OTHER||percentage|53.4|||||ONE_SIDED|95.0|44.8||||One sided 95% confidence interval|||Blinded Reader 3|||44.8|
91515523|NCT01344460|182903733|SUPERIORITY_OR_OTHER||percentage|71.3|||||ONE_SIDED|95.0|64.7||||One sided 95% confidence interval|||Clinical investigator|||64.7|
91515524|NCT01344460|182903734|SUPERIORITY_OR_OTHER||percentage|95.9|||||ONE_SIDED|95.0|94.9||||One sided 95% confidence interval|||Majority reader|||94.9|
91515525|NCT01344460|182903734|SUPERIORITY_OR_OTHER||percentage|95.0|||||ONE_SIDED|95.0|93.8||||One sided 95% confidence interval|||Blinded Reader 1|||93.8|
91515526|NCT01344460|182903734|SUPERIORITY_OR_OTHER||percentage|96.2|||||ONE_SIDED|95.0|95.2||||One sided 95% confidence interval|||Blinded Reader 2|||95.2|
91515527|NCT01344460|182903734|SUPERIORITY_OR_OTHER||percentage|95.8|||||ONE_SIDED|95.0|94.8||||One sided 95% confidence interval|||Blinded Reader 3|||94.8|
91515528|NCT01344460|182903734|SUPERIORITY_OR_OTHER||percentage|98.4|||||ONE_SIDED|95.0|97.8||||One sided 95% confidence interval|||Clinical investigator|||97.8|
91515529|NCT01344460|182903737|SUPERIORITY_OR_OTHER||Diameter difference|0.17|STANDARD_DEVIATION|1.28|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
91515530|NCT01344460|182903737|SUPERIORITY_OR_OTHER||Diameter difference|-0.09|STANDARD_DEVIATION|1.14|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
91515531|NCT01344460|182903737|SUPERIORITY_OR_OTHER||Mean Difference|0.41|STANDARD_DEVIATION|1.15|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
91515532|NCT01344460|182903737|SUPERIORITY_OR_OTHER||Diameter difference|-0.15|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
91515533|NCT02120924|182903766|EQUIVALENCE|Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|Mean Difference (Net)|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|The primary endpoint was the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.||1.05|0.92|
91515534|NCT02120924|182903767|EQUIVALENCE|A two-sided, continuity-corrected, 90% CI on the Test-to-Reference difference for the proportion of subjects with treatment success on the IGE was constructed.|Mean Difference (Net)|0.044|||||TWO_SIDED|90.0|-0.028|0.116|||||Bioequivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\].|||0.116|-0.028|
91515535|NCT03483623|182903768|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515536|NCT03483623|182903769|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515537|NCT03483623|182903770|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515538|NCT03483623|182903771|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515539|NCT03483623|182903772|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515540|NCT03483623|182903773|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515541|NCT03483623|182903774|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515542|NCT03483623|182903775|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
91515543|NCT01884350|182903776|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.24||||0.8117|TWO_SIDED|95.0|-2.18|1.7||P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24|t-test, 2 sided|||||1.7|-2.18|0.8117
91515544|NCT01884350|182903777|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
91515545|NCT01884350|182903777|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
91515546|NCT01884350|182903778|NON_INFERIORITY_OR_EQUIVALENCE|F-test p-value is obtained from the one-way ANOVA model||||||0.8707|||||||ANOVA|||||||0.8707
91515547|NCT01884350|182903778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6399|TWO_SIDED|95.0|-2.88|4.68||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.68|-2.88|0.6399
91515548|NCT01884350|182903778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.9616|TWO_SIDED|95.0|-3.45|3.29||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||3.29|-3.45|0.9616
91515549|NCT01884350|182903778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.6341|TWO_SIDED|95.0|-2.6|4.24||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.24|-2.60|0.6341
91515550|NCT01884350|182903779|SUPERIORITY|||||||0.1924||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1924
91515551|NCT01884350|182903779|SUPERIORITY|||||||0.0305||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0305
91515552|NCT01884350|182903779|SUPERIORITY|||||||0.0107||||||Mini-mental state examination score|Wald Chi-square test|||||||0.0107
91515553|NCT01884350|182903779|SUPERIORITY|||||||0.6982||||||Higher managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.6982
91515554|NCT01884350|182903779|SUPERIORITY|||||||0.7277||||||Higher professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7277
91515555|NCT01884350|182903779|SUPERIORITY|||||||0.7581||||||Intermediate occupations vs UKSOC1|Wald Chi-square test|||||||0.7581
91515556|NCT01884350|182903779|SUPERIORITY|||||||0.2328||||||Large employers and higher managerial and adm. occupations vs UKSOC1|Wald Chi-square test|||||||0.2328
91515557|NCT01884350|182903779|SUPERIORITY|||||||0.7507||||||Lower managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7507
91515558|NCT01884350|182903779|SUPERIORITY|||||||0.0091||||||Lower supervisory and technical occupations vs UKSOC1|Wald Chi-square test|||||||0.0091
91515559|NCT01884350|182903779|SUPERIORITY|||||||0.673||||||Never worked and long-term unemployed vs UKSOC1|Wald Chi-square test|||||||0.6730
91515560|NCT01884350|182903779|SUPERIORITY|||||||0.0117||||||Routine occupations vs UKSOC1|Wald Chi-square test|||||||0.0117
91515561|NCT01884350|182903779|SUPERIORITY|||||||0.191||||||Semi-routine occupations vs UKSOC1|Wald Chi-square test|||||||0.1910
91515562|NCT01884350|182903779|SUPERIORITY|||||||0.9559||||||Paroxysmal vs Persistent Atrial Fibrillation|Wald Chi-square test|||||||0.9559
91515563|NCT01884350|182903779|SUPERIORITY|||||||0.0264||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.0264
91515564|NCT01884350|182903779|SUPERIORITY|||||||0.1087||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1087
91515565|NCT01884350|182903779|SUPERIORITY|||||||0.0679||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0679
91515566|NCT01884350|182903779|SUPERIORITY|||||||0.2128||||||Paroxysmal vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.2128
91515567|NCT01884350|182903779|SUPERIORITY|||||||0.3739||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.3739
91515568|NCT01884350|182903779|SUPERIORITY|||||||0.843||||||VKA status: Naive vs. Non-Naive|Wald Chi-square test|||||||0.843
91515569|NCT03403634|182903788|SUPERIORITY|||||||0.046||||||significance level = 0.05|t-test, 1 sided|df = 11. one-sided as post treatment increases were of interest. the fold changes were log-transformed prior to inferences.||||||0.046
91515570|NCT00434057|182903812|SUPERIORITY_OR_OTHER||Sensitivity to melanoma|98.0||||0.05||95.0|95.1|100.0|||exact mid-P||"Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of Melanoma can not be ruled out or Not melanoma, which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas."|MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.||100|95.1|0.05
91515571|NCT00434057|182903812|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.||||0.02
91515572|NCT00823719|182903826|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|48.2|85.7|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.|||85.7|48.2|
91515573|NCT00823719|182903826|SUPERIORITY_OR_OTHER||percentage of participants|55.0|||||TWO_SIDED|95.0|36.4|71.9|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.|||71.9|36.4|
91515574|NCT00823719|182903826|SUPERIORITY_OR_OTHER||percentage of participants|61.0|||||TWO_SIDED|95.0|47.4|73.5|||||The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.|||73.5|47.4|
91515575|NCT02103439|182903865|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95% confidence interval for the difference in proportions between the difference in the early virological response rate with Algeron and PegIntron should be higher than the non-inferiority margin of 0.2 (-20%)||||||0.227|TWO_SIDED||||||Fisher Exact|||||||0.227
91515576|NCT02103439|182903866|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95 % confidence interval between the difference in rate of rapid virological response with Algeron and PegIntron should be more than the non-inferiority margin (-20 %)|||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||> 0.05
91515577|NCT00784810|182903871|NON_INFERIORITY_OR_EQUIVALENCE|As above.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|1.19||0.002|ONE_SIDED|90.0|-5.65||||Mixed Models Analysis|||To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.|||-5.65|0.002
91515578|NCT02119416|182903888|OTHER|Maximum heart rate after 2 mg/kg of caffeine compared to baseline was assessed using a mixed effects regression model. Sex and pubertal stage were included in the model as time invariant predictors.|||||<|0.05||||||The p-value was not adjusted for multiple comparisons.|mixed effects regression|||||||<0.05
91515579|NCT02119416|182903888|OTHER|We compared means of our dependent variables after administration of different doses of caffeine.|||||<|0.05||||||The p-value was set prior to the analysis and all comparisons were planned.|ANCOVA|||We used repeated measures ANOVAS and conducted planned comparisons between groups as post-hoc tests.||||< 0.05
91515580|NCT02119416|182903889|OTHER|mixed effects regression models were used with sex and pubertal stage as time invariant predictors.|||||<|0.05|||||||mixed effects regression|||order was included in the analysis. We examined caffeine dose.||||<0.05
91515581|NCT02119416|182903889|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
91515582|NCT00377676|182903931|NON_INFERIORITY_OR_EQUIVALENCE|In order to test the primary hypothesis at a one-sided alpha = .05 and have a power of 0.9, when the non-inferiority margin is 1.5, the total number of subjects with all-cause SAEs that must be observed during the study was found to be 235. Assuming the placebo rate is 0.08, the required sample size was found to be 2991.|Hazard Ratio (HR)|1.02|||<|0.05|ONE_SIDED|95.0||1.27||Using the Lan and Demets alpha spending function for O'Brien-Fleming boundaries and the overall one-sided significance level of 5%, a level of 0.04068 was to be used at the interim analysis and 0.03938 at the time of the final analysis.|Regression, Cox||cycloset to placebo|||1.27||<0.05
91515583|NCT00377676|182903932|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58|||<|0.05|TWO_SIDED|95.0|0.35|0.96|||Regression, Cox|||In order to test the hypothesis for serious cardiovascular adverse events as for the primary endpoint at a one-sided alpha = 0.5 when the non-inferiority margin is 1.5, the final sample size of 3000 to 3300 subjects was to provide at least 62% power, assuming a hypothetical rate of events of 3.43%, or 103 to 113 cardiovascular SAEs. Upon demonstration of non-inferiority - a 2 sided using 95% CI was used to assess for superiority.||.96|.35|<0.05
91515584|NCT00377676|182903933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.4|<|0.001|||||||ANOVA|||If the standard deviation of HbA1c level is about 1.0% and the baseline and 24 week scores have a correlation of 0.50 then the effect size is 0.5%/1.0% = 0.50. For the metformin/SU analysis, 160 subjects assuming a standard deviation of 1.0% would provide a power of 90% power to detect differences in mean changes of 0.5% or larger.||||<0.001
91515585|NCT00377676|182903934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|||||||ANOVA|||||||<0.001
91515586|NCT03579459|182903942|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|Geometric Mean ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||Confidence intervals (CIs) were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
91515587|NCT03579459|182903942|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
91515588|NCT03579459|182903942|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.17|0.85|
91515589|NCT03579459|182903942|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.87|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.87|
91515590|NCT03579459|182903942|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.88|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.88|
91515591|NCT03579459|182903942|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.83|1.23|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.23|0.83|
91515592|NCT02528214|182903951|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Least Square (LS) Mean Difference|28.24|||<|0.0001|TWO_SIDED|95.0|15.81|40.67||Threshold for significance at two-sided 0.05 level.|ANCOVA||LS mean difference represents reduction difference i.e. dupilumab - placebo.|The outcome measure was analyzed using analysis of covariance (ANCOVA) model which included percentage reduction of OCS dose at Week 24 as the response variable, and treatment group, baseline eosinophil level, optimized OCS dose at baseline, region as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||40.67|15.81|< 0.0001
91515593|NCT02528214|182903953|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.06|7.67||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved the 50% OCS dose reduction criterion as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||7.67|2.06|< 0.0001
91515594|NCT02528214|182903954|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|4.48|||<|0.0001|TWO_SIDED|95.0|2.39|8.39||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved a reduction of OCS dose to \<5 mg/day at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||8.39|2.39|< 0.0001
91515595|NCT02528214|182903955|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.57||||0.0024|TWO_SIDED|95.0|1.4|4.73||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome was analyzed using a logistic regression model. The model included binary status of whether or not a participant achieved their maximum possible reduction of OCS dose per protocol at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||4.73|1.4|0.0024
91515596|NCT02528214|182903956|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.74||||0.0015|TWO_SIDED|95.0|1.47|5.1||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant no longer required OCS at Week 24 as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||5.1|1.47|0.0015
91515597|NCT00407537|182903965|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.72|||<|0.001|TWO_SIDED|95.0|-5.55|-3.89||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.||-3.89|-5.55|<0.001
91515598|NCT00407537|182903966|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.76|||<|0.001|TWO_SIDED|95.0|-5.58|-3.93||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-3.93|-5.58|<0.001
91515599|NCT00407537|182903967|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.23|-0.72||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.72|-1.23|<0.001
91515600|NCT00407537|182903968|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.16|-0.59||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.59|-1.16|<0.001
91515601|NCT00407537|182903969|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.56|-1.15||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.15|-1.56|<0.001
91515602|NCT00407537|182903970|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.57|-1.14||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.14|-1.57|<0.001
91515603|NCT00407537|182903975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.15|||<|0.007|TWO_SIDED|95.0|-5.42|-0.88|||Mixed-effect linear model|||||-0.88|-5.42|<0.007
91515604|NCT00407537|182903976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|||<|0.011|TWO_SIDED|95.0|-2.86|-0.37|||Mixed-effect linear model|||||-0.37|-2.86|<0.011
91515605|NCT00407537|182903977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.75|||<|0.001|TWO_SIDED|95.0|-8.0|-3.5|||Mixed-effect linear model|||||-3.50|-8.00|<0.001
91515606|NCT00407537|182903978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.42|-1.92|||Mixed-effect linear model|||||-1.92|-4.42|<0.001
91515607|NCT00407537|182903979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
91515608|NCT00407537|182903979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
91515609|NCT00407537|182903979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||2.13|-0.14|0.087
91579278|NCT02270515|183048001|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
91515610|NCT00407537|182903979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effects linear model|||Triglycerides||-14.70|-32.60|<0.001
91515611|NCT00407537|182903980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-28.56|-37.57|<0.001
91515612|NCT00407537|182903980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
91515613|NCT00407537|182903980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||1.86|-0.71|0.379
91515614|NCT00407537|182903980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
91515615|NCT00407537|182903981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
91579279|NCT05745701|183048002|OTHER||test/reference ratios|195.9|||||TWO_SIDED|90.0|162.13|236.71||||||Natural loge transformed Cmax of PF-07081532 administered without cyclosporine (Reference) or coadministered with cyclosporine (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||236.71|162.13|
91515616|NCT00407537|182903981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
91515617|NCT00407537|182903981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||2.13|-0.14|0.087
91515618|NCT00407537|182903981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-14.70|-32.60|<0.001
91515619|NCT00407537|182903982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Total cholesterol||-28.56|-37.57|<0.001
91515620|NCT00407537|182903982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
91515621|NCT00407537|182903982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||1.86|-0.71|0.379
91515622|NCT00407537|182903982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
91515623|NCT03593655|182903988|SUPERIORITY||incidence rate ratio|1.01||||0.92|TWO_SIDED|95.0|0.9|1.12||the a priori threshold for statistical significance was \<0.05|generalized estimating equation|Poisson (log) link, adjusted for period, offset of number of visits per period, exchangeable correlation structure, and robust errors.|The incidence rate ratio compares FTC/TDF to the dapivirine vaginal ring.|Comparison of the proportion of participants experiencing a grade 2 adverse event between products, with a null hypothesis of no difference.||1.12|0.90|0.92
91515624|NCT00762320|182903998|SUPERIORITY_OR_OTHER||||||=|0.004|||||||t-test, 2 sided|df=4||||||=.004
91515625|NCT00762320|182904003|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|df=7||||||<.001
91515626|NCT01660763|182904065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.59|STANDARD_ERROR_OF_MEAN|10.88|<|0.001|TWO_SIDED|95.0|66.2|108.98|||ANCOVA|||||108.98|66.20|<0.001
91515627|NCT00952653|182904077|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|71.4|||||TWO_SIDED|90.0|65.08|78.33|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||78.33|65.08|
91515628|NCT00952653|182904078|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|86.08|||||TWO_SIDED|90.0|79.04|93.74|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||93.74|79.04|
91515629|NCT00952653|182904079|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|92.55|||||TWO_SIDED|90.0|87.43|97.97|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||97.97|87.43|
91515630|NCT00952653|182904080|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|101.17|||||TWO_SIDED|90.0|92.96|110.11|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||110.11|92.96|
91515631|NCT00952653|182904081|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|72.1|||||TWO_SIDED|90.0|66.04|78.72|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||78.72|66.04|
91515632|NCT00952653|182904084|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|87.39|||||TWO_SIDED|90.0|80.42|94.96|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||94.96|80.42|
91515633|NCT01365494|182904087|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667|Ratio of GMCs-Zagreb and Essen at day 14|1.03|||||TWO_SIDED|95.0|0.89|1.19|||ANOVA|||To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14||1.19|0.89|
91515634|NCT01365494|182904089|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 7|0.38|||||TWO_SIDED|95.0|0.3|0.48|||ANOVA|||||0.48|0.3|
91515635|NCT01365494|182904089|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 42|0.96||||||95.0|0.86|1.07|||ANOVA|||||1.07|0.86|
91579280|NCT05745701|183048002|OTHER||test/reference ratios|282.13|||||TWO_SIDED|90.0|258.81|307.55||||||Natural loge transformed Cmax of PF-07081532 administered without itraconazole (Reference) or coadministered with itraconazole (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||307.55|258.81|
91515636|NCT03021187|182904093|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.7|< 0.0001
91515637|NCT03021187|182904093|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.7|-1.1|< 0.0001
91515638|NCT03021187|182904093|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-1.4|< 0.0001
91579281|NCT01607476|183048020|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91579282|NCT01607476|183048020|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91579283|NCT01607476|183048020|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91579284|NCT01607476|183048021|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91579285|NCT01607476|183048021|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91579286|NCT01607476|183048021|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
91579287|NCT01821352|183048065|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
91579288|NCT01821352|183048066|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
91579289|NCT01821352|183048067|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
91515639|NCT03021187|182904093|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
91515640|NCT03021187|182904093|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
91515641|NCT03021187|182904093|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.6|<0.0001
91515642|NCT03021187|182904094|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0392|TWO_SIDED|95.0|-1.8|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.0|-1.8|0.0392
91515643|NCT03021187|182904094|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.0||||0.0001|TWO_SIDED|95.0|-3.0|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-3.0|0.0001
91515644|NCT03021187|182904094|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.2|-2.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.3|-4.2|<0.0001
91579290|NCT05260021|183048089|SUPERIORITY||LS Mean difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.35|-1.25|||ANCOVA|||||-1.25|-2.35|<0.001
91579291|NCT05260021|183048090|SUPERIORITY||LS Mean difference (Final Values)|-1.67|||<|0.001|TWO_SIDED|95.0|-2.31|-1.02|||ANCOVA|||||-1.02|-2.31|<0.001
91579292|NCT05260021|183048090|SUPERIORITY||LS Mean difference (Final Values)|-1.93|||<|0.001|TWO_SIDED|95.0|-2.57|-1.29|||ANCOVA|||||-1.29|-2.57|<0.001
91579293|NCT05260021|183048091|SUPERIORITY||Risk Difference (RD)|40.1|||<|0.001|TWO_SIDED|95.0|18.6|61.7|||Regression, Logistic|||||61.7|18.6|<0.001
91579294|NCT05260021|183048091|SUPERIORITY||Risk Difference (RD)|51.6|||<|0.001|TWO_SIDED|95.0|31.1|72.2|||Regression, Logistic|||||72.2|31.1|<0.001
91579295|NCT05260021|183048091|SUPERIORITY||Risk Difference (RD)|45.8|||<|0.001|TWO_SIDED|95.0|27.5|64.1|||Regression, Logistic|||||64.1|27.5|<0.001
91579296|NCT05260021|183048092|SUPERIORITY||LS Mean difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||||-0.16|-0.55|< 0.001
91579297|NCT05260021|183048092|SUPERIORITY||LS Mean difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA|||||-0.47|-0.86|<0.001
91579298|NCT05260021|183048092|SUPERIORITY||LS Mean difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.34|||ANCOVA|||||-0.34|-0.68|< 0.001
91579299|NCT05260021|183048093|SUPERIORITY||LS Mean difference (Final Values)|-28.9||||0.007|TWO_SIDED|95.0|-49.7|-8.0|||ANCOVA|||||-8.0|-49.7|0.007
91515645|NCT03021187|182904094|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.9||||0.0111|TWO_SIDED|95.0|-1.6|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.6|0.0111
91515646|NCT03021187|182904094|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.2|<0.0001
91515647|NCT03021187|182904094|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.4|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.0|-4.4|<0.0001
91515648|NCT03021187|182904114|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.73||||0.0627|TWO_SIDED|95.0|0.53|1.02||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.02|0.53|0.0627
91515649|NCT03021187|182904114|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.0083|TWO_SIDED|95.0|0.44|0.89||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.89|0.44|0.0083
91515650|NCT03021187|182904114|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.57||||0.0019|TWO_SIDED|95.0|0.4|0.81||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.81|0.40|0.0019
91579300|NCT05260021|183048093|SUPERIORITY||LS Mean difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-64.3|-23.6|||ANCOVA|||||-23.6|-64.3|< 0.001
91515651|NCT03021187|182904115|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.121|TWO_SIDED|95.0|0.53|1.08||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.08|0.53|0.1210
91515652|NCT03021187|182904115|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.0007|TWO_SIDED|95.0|0.32|0.74||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.74|0.32|0.0007
91515653|NCT03021187|182904115|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0006|TWO_SIDED|95.0|0.31|0.73||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.73|0.31|0.0006
91515654|NCT03351049|182904130|SUPERIORITY|||||||0.8|||||||Chi-squared|||Compare the effectiveness of reactive support surfaces with and without low air loss in preventing pressure injuries||||0.8
91515655|NCT00718718|182904131|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
91579301|NCT05260021|183048093|SUPERIORITY||LS Mean difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-54.2|-18.6|||ANCOVA|||||-18.6|-54.2|< 0.001
91579302|NCT05260021|183048094|SUPERIORITY||LS Mean difference (Final Values)|-6.18|||<|0.001|TWO_SIDED|95.0|-9.31|-3.05|||ANCOVA|||||-3.05|-9.31|< 0.001
91515656|NCT00718718|182904131|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|||||||0.052
91515657|NCT00718718|182904131|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
91515658|NCT00718718|182904131|SUPERIORITY_OR_OTHER|||||||0.104|||||||Cochran-Mantel-Haenszel|||||||0.104
91515659|NCT00718718|182904132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
91515660|NCT00718718|182904132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
91515661|NCT00718718|182904132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
91579303|NCT05260021|183048094|SUPERIORITY||LS Mean difference (Final Values)|-10.52|||<|0.001|TWO_SIDED|95.0|-13.67|-7.38|||ANCOVA|||||-7.38|-13.67|< 0.001
91515662|NCT00718718|182904132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
91515663|NCT00718718|182904132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
91515664|NCT00718718|182904133|SUPERIORITY_OR_OTHER|||||||0.148|||||||Cochran-Mantel-Haenszel|||||||0.148
91515665|NCT02939105|182904138|OTHER||success proportion|86.7|||||TWO_SIDED|95.0|69.3|96.2||||||||96.2|69.3|
91515666|NCT01802411|182904142|SUPERIORITY||LSMD|13.1||||0.5598|TWO_SIDED|95.0|-31.0|57.0|||ANCOVA|||||57|-31|0.5598
91515667|NCT01812044|182904146|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.035
91515668|NCT01812044|182904146|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.189
91515669|NCT01812044|182904146|SUPERIORITY_OR_OTHER|||||||0.298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.298
91515670|NCT02670629|182904171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
91515671|NCT01165281|182904182|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.226||0.786|TWO_SIDED|95.0|-0.506|0.383|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and country as factors and baseline pain intensity score as a covariate.||The primary hypothesis to be tested for the study was that the JNS024 ER group was not inferior to oxycodone CR as defined by the upper limit of the 95% confidence interval of the difference between JNS024 ER and oxycodone CR on the mean change from baseline of the NRS pain intensity score during the last 3 days of study drug administration. It was to be concluded that JNS024 ER is not inferior to oxycodone CR if the upper 95% confidence limit is less than 1 point.||0.383|-0.506|0.786
91515672|NCT00364858|182904190|SUPERIORITY_OR_OTHER||Agresti and Min|-0.176||||||95.0|-0.357|0.058||||||Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).||0.058|-0.357|
91515673|NCT02730819|182904217|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
91515674|NCT02730819|182904218|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
91515675|NCT02099006|182904276|SUPERIORITY_OR_OTHER|||||||0.3|||||||t-test, 2 sided|Paired T test||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.||||0.30
91515676|NCT02099006|182904276|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.||||0.33
91515677|NCT02099006|182904276|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.||||0.65
91515678|NCT02099006|182904276|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.||||0.25
91515679|NCT02099006|182904276|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.||||1.0
91515680|NCT02099006|182904277|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.||||0.31
91515681|NCT02099006|182904277|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.||||1
91515682|NCT02099006|182904277|SUPERIORITY_OR_OTHER|||||||0.66|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.||||0.66
91515683|NCT02099006|182904277|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.||||0.42
91515684|NCT02099006|182904277|SUPERIORITY_OR_OTHER|||||||0.79|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.||||0.79
91579304|NCT05260021|183048094|SUPERIORITY||LS Mean difference (Final Values)|-8.35|||<|0.001|TWO_SIDED|95.0|-11.05|-5.66|||ANCOVA|||||-5.66|-11.05|< 0.001
91579305|NCT05260021|183048095|SUPERIORITY||Risk Difference (RD)|29.5||||0.006|TWO_SIDED|95.0|8.6|50.3|||Regression, Logistic|||||50.3|8.6|0.006
91579306|NCT05260021|183048095|SUPERIORITY||Risk Difference (RD)|39.5|||<|0.001|TWO_SIDED|95.0|18.8|60.2|||Regression, Logistic|||||60.2|18.8|< 0.001
91579307|NCT05260021|183048095|SUPERIORITY||Risk Difference (RD)|34.6|||<|0.001|TWO_SIDED|95.0|17.0|52.1|||Regression, Logistic|||||52.1|17|< 0.001
91515685|NCT01308580|182904278|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.214|Hazard Ratio (HR)|1.024|||||ONE_SIDED|98.89||1.184|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.||1.184||
91515686|NCT01308580|182904278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024|||||ONE_SIDED|95.0|0.922||||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.|||0.922|
91515687|NCT01308580|182904279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099|||||TWO_SIDED|95.0|0.974|1.24|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.24|0.974|
91515688|NCT01308580|182904280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.902|1.331|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.331|0.902|
91515689|NCT01308580|182904282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||||TWO_SIDED|95.0|1.025|1.393|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.393|1.025|
91515690|NCT01308580|182904284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.874|1.251|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.251|0.874|
91579308|NCT05260021|183048096|SUPERIORITY||Risk Difference (RD)|43.4|||<|0.001|TWO_SIDED|95.0|22.3|64.4|||Regression, Logistic|||||64.4|22.3|< 0.001
91515691|NCT01461668|182904452|SUPERIORITY||Odds Ratio (OR)|0.41||||0.32|TWO_SIDED|95.0|0.08|1.86|||Fisher Exact||Confidence interval for the odds ratio is based upon the inversion Fisher's exact test|||1.86|0.08|0.320
91515692|NCT01760239|182904456|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
91515693|NCT01760239|182904457|SUPERIORITY||Odds Ratio (OR)|2.36||||0.046|TWO_SIDED||||||Mixed Models Analysis|||||||.046
91515694|NCT01760239|182904458|SUPERIORITY||Odds Ratio (OR)|5.13||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
91515695|NCT01983293|182904459|SUPERIORITY|||||||0.001|ONE_SIDED|95.0|||||Fisher Exact|||||||0.001
91515696|NCT03147248|182904461|NON_INFERIORITY|The non-inferiority was to be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change from baseline of DAS28 (CRP) at Week 22 was greater that the pre-specified non-inferiority margin of -0.6.|Difference of Least square mean|0.27|||||TWO_SIDED|95.0|0.02|0.52|||||The least squares means and standard errors, estimate of treatment difference (CT-P13 SC 120 mg - CT-P13 IV 3 mg/kg), and 2-sided 95% CI obtained from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA considering the treatment as fixed effect and country, serum CRP concentration at Week 2 (≤0.6 mg/dL vs. \>0.6 mg/dL), and body weight at Week 6 (≤100 kg vs. \>100 kg) as covariates.||0.52|0.02|
91515697|NCT03248739|182904466|EQUIVALENCE|Based on occlusion data from the previously referenced prospective study, as well as a P-value of 0.05 and power of 0.80, the study will need to include 90 patients to demonstrate statistical significance. To ensure that power is adequate, we will plan to enroll 120 patients (60 in each arm).||||||0.23|||||||Fisher Exact|||||||0.23
91515698|NCT01914926|182904471|NON_INFERIORITY_OR_EQUIVALENCE|Chi-Square test||||||0.0001||95.0|||||Chi-squared|||We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.||||.0001
91515699|NCT03073603|182904691|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0753||||0.521|TWO_SIDED|95.0|0.0063|0.15|||Exact binomial test|Exact binomial test for difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1500|0.0063|0.521
91579309|NCT05260021|183048096|SUPERIORITY||Risk Difference (RD)|47.1|||<|0.001|TWO_SIDED|95.0|26.4|67.7|||Regression, Logistic|||||67.7|26.4|< 0.001
91515700|NCT03073603|182904692|SUPERIORITY|||||||0.766|||||||Chi-squared|||||||0.766
91515701|NCT03073603|182904693|SUPERIORITY|||||||0.604|||||||t-test, 2 sided|||||||0.604
91515702|NCT03073603|182904694|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||||||0.198
91515703|NCT03073603|182904695|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||||||0.354
91579310|NCT05260021|183048096|SUPERIORITY||Risk Difference (RD)|45.2|||<|0.001|TWO_SIDED|95.0|26.3|64.1|||Regression, Logistic|||||64.1|26.3|< 0.001
91579311|NCT05260021|183048098|SUPERIORITY||LS Mean difference (Final Values)|0.014||||0.708|TWO_SIDED|95.0|-0.061|0.089|||Mixed Models Analysis|||||0.089|-0.061|0.708
91579312|NCT05260021|183048098|SUPERIORITY||LS Mean difference (Final Values)|-0.001||||0.976|TWO_SIDED|95.0|-0.076|0.074|||Mixed Models Analysis|||||0.074|-0.076|0.976
91579313|NCT05260021|183048098|SUPERIORITY||LS Mean difference (Final Values)|0.007||||0.841|TWO_SIDED|95.0|-0.058|0.071|||Mixed Models Analysis|||||0.071|-0.058|0.841
91579314|NCT05260021|183048099|SUPERIORITY||LS Mean difference (Final Values)|-0.29|||<|0.001|TWO_SIDED|95.0|-0.45|-0.12|||Mixed Models Analysis|||||-0.12|-0.45|< 0.001
91579315|NCT05260021|183048099|SUPERIORITY||LS Mean difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.24|||Mixed Models Analysis|||||-0.24|-0.57|< 0.001
91515704|NCT03073603|182904696|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|||||||0.831
91515705|NCT03073603|182904697|SUPERIORITY|||||||0.252|||||||t-test, 2 sided|||||||0.252
91515706|NCT03073603|182904698|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||||||0.983
91515707|NCT03073603|182904699|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
91515708|NCT03073603|182904700|SUPERIORITY|||||||0.748|||||||t-test, 2 sided|||||||0.748
91515709|NCT03073603|182904701|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
91579316|NCT05260021|183048099|SUPERIORITY||LS Mean difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.49|-0.2|||Mixed Models Analysis|||||-0.2|-0.49|< 0.001
91579317|NCT01241604|183048132|EQUIVALENCE|Equivalent non-parametric tests||||||0.753|||||||Wilcoxon signed ranks test|||||||.753
91515710|NCT03073603|182904702|SUPERIORITY|||||||0.224|||||||t-test, 2 sided|||||||0.224
91515711|NCT03073603|182904703|SUPERIORITY|||||||0.962|||||||t-test, 2 sided|||||||0.962
91515712|NCT03073603|182904704|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
91515713|NCT03073603|182904705|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||0.406
91515714|NCT03073603|182904706|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
91515715|NCT03073603|182904707|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||||||0.086
91515716|NCT03073603|182904708|SUPERIORITY|||||||0.575|||||||t-test, 2 sided|||||||0.575
91515717|NCT03073603|182904709|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
91515718|NCT03073603|182904710|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
91515719|NCT03073603|182904711|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
91515720|NCT00373334|182904726|SUPERIORITY_OR_OTHER|||||||0.528||95.0|||||Cochran-Mantel-Haenszel|||||||0.528
91515721|NCT00373334|182904726|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||Cochran-Mantel-Haenszel|||||||0.341
91515722|NCT00373334|182904727|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.746
91515723|NCT00373334|182904727|SUPERIORITY_OR_OTHER|||||||0.262||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.262
91515724|NCT00373334|182904728|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.609
91515725|NCT00373334|182904728|SUPERIORITY_OR_OTHER|||||||0.938||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.938
91515726|NCT00413153|182904784|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).||||0.035
91515727|NCT00413153|182904785|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs. LPV/r)||||0.12
91515728|NCT00413153|182904786|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.002
91515729|NCT00413153|182904787|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.02
91515730|NCT00413153|182904788|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.047
91515731|NCT00413153|182904789|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.72
91515732|NCT00413153|182904790|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.22
91515733|NCT00413153|182904791|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Repeated Measures Ancova|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.004
91515734|NCT00413153|182904792|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.0002
91515735|NCT00924885|182904804|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The primary end-point was the 'overall pain experience', evaluated as described previously. Assuming the mean overall pain in the RN group to be 27 mm (value chosen after analysis of data from a previous study, Cerne et al., 2006) on VAS, with a standard deviation (SD) of 21.5 mm, 121 patients in each group would be needed to demonstrate a decrease in overall pain of 8 mm (30%) with 80% power and a significance level of 0.05 (two-tailed tests).||||0.04
91579318|NCT01133418|183048169|SUPERIORITY_OR_OTHER|||||||0.36||||||a priori threshold for statistical significance was .05|General Linear Model|||||||.36
91579319|NCT01133418|183048170|SUPERIORITY_OR_OTHER|||||||0.86|||||||General Linear Model|||||||.86
91579320|NCT01133418|183048171|SUPERIORITY_OR_OTHER|||||||0.79|||||||General Linear Model|||||||.79
91579321|NCT01133418|183048172|SUPERIORITY_OR_OTHER|||||||0.77|||||||General Linear Model|||||||.77
91579322|NCT04150068|183048173|SUPERIORITY|The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority.|Percentage Difference|70.8|||<|0.0001|TWO_SIDED|95.0|34.9|90.0||The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.|Chan & Zhang method|||||90.0|34.9|< 0.0001
91579323|NCT05316701|183048182|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|1e-05|TWO_SIDED|95.0|0.14|0.47|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.47|0.14|<0.00001
91579324|NCT05316701|183048183|SUPERIORITY||Hazard Ratio (HR)|0.19||||2e-05|TWO_SIDED|95.0|0.08|0.43|||Gray's test|||Gray's test was stratified by randomization stratification factors.||0.43|0.08|0.00002
91579325|NCT05316701|183048184|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.11823|TWO_SIDED|95.0|0.2|1.22|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||1.22|0.20|0.11823
91579326|NCT05316701|183048185|SUPERIORITY||Hazard Ratio (HR)|0.37||||3e-05|TWO_SIDED|95.0|0.23|0.6|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.60|0.23|0.00003
91579327|NCT04679935|183048186|OTHER|Analysis was purely descriptive.|Difference|-3.74|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|95.0|-7.47|-0.01|||MMRM model|||Week 40||-0.01|-7.47|
91579328|NCT04679935|183048186|OTHER|Analysis was purely descriptive.|Difference|-4.15|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-8.78|-0.48|||MMRM model|||Week 44||-0.48|-8.78|
91579329|NCT04679935|183048186|OTHER|Analysis was purely descriptive.|Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-10.13|-0.58|||MMRM model|||Week 48||-0.58|-10.13|
91579330|NCT04679935|183048186|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|0.39|||MMRM model|||Week 52||0.39|-8.77|
91579331|NCT04679935|183048186|OTHER|Analysis was purely descriptive.|Difference|-4.36|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|-8.56|-0.16|||MMRM model|||Mean of Week 40 to Week 52||-0.16|-8.56|
91579332|NCT04679935|183048194|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|-0.39|||MMRM model|||Week 52||-0.39|-8.77|
91579333|NCT02731690|183048217|SUPERIORITY|||||||0.5303||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5303
91579334|NCT02731690|183048217|SUPERIORITY|||||||0.1646||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1646
91579335|NCT02731690|183048217|SUPERIORITY|||||||0.1189||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1189
91579336|NCT02731690|183048217|SUPERIORITY|||||||0.0706||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0706
91579337|NCT02731690|183048218|SUPERIORITY|||||||0.0715||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0715
91579338|NCT02731690|183048218|SUPERIORITY|||||||0.1697||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1697
91579339|NCT02731690|183048218|SUPERIORITY|||||||0.3428||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.3428
91579340|NCT02731690|183048218|SUPERIORITY|||||||0.0642||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0642
91579341|NCT02731690|183048219|SUPERIORITY|||||||0.0568||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0568
91579342|NCT02731690|183048219|SUPERIORITY|||||||0.0533||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0533
91579343|NCT02731690|183048219|SUPERIORITY|||||||0.0459||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0459
91579344|NCT02731690|183048219|SUPERIORITY|||||||0.5678||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.5678
91579345|NCT02731690|183048220|SUPERIORITY|||||||0.581||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5810
91579346|NCT02731690|183048220|SUPERIORITY|||||||0.0465||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0465
91579347|NCT02731690|183048220|SUPERIORITY|||||||0.1047||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1047
91579348|NCT02731690|183048220|SUPERIORITY|||||||0.0661||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0661
91579349|NCT02731690|183048221|SUPERIORITY|||||||0.1615||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.1615
91515736|NCT02508480|182904815|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect.||||0.66
91515737|NCT02508480|182904816|SUPERIORITY|||||||0.884||||||Group effect for Proactive Coping|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Proactive Coping."||||0.884
91515738|NCT02508480|182904816|SUPERIORITY|||||||0.543||||||Group effect for Avoidant Coping.|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Avoidant Coping."||||0.543
91515739|NCT02508480|182904817|SUPERIORITY|||||||0.135||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.135
91515740|NCT02508480|182904818|SUPERIORITY|||||||0.25||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the interpersonal function subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.25
91515741|NCT02508480|182904818|SUPERIORITY|||||||0.118||||||The p-value represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the intrapsychic foundations subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.118
91515742|NCT02508480|182904819|SUPERIORITY|||||||0.917||||||The p-value is for group effect for tcpm\_days\_participated.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect for tcpm\_days\_participated.||||0.917
91515743|NCT02508480|182904820|SUPERIORITY|||||||0.017||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.017
91515744|NCT02508480|182904821|SUPERIORITY|||||||0.597||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.597
91515745|NCT02508480|182904822|SUPERIORITY|||||||0.076||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.076
91515746|NCT02508480|182904823|SUPERIORITY|||||||0.978||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.978
91515747|NCT04969250|182904829|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
91515748|NCT04969250|182904830|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
91515749|NCT04969250|182904831|SUPERIORITY|||||||0.078|||||||Fisher Exact|||||||0.078
91515750|NCT04969250|182904832|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
91515751|NCT04420221|182904854|SUPERIORITY||Vaccine Efficacy (VE)|-74.76||||0.8042||92.5|-680.61|36.62|||Log Rank|One-sided Group Sequential Design with non-binding beta, yielding two CIs based on cumulative alpha (92.5%) and beta (80.5%) spending|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||36.62|-680.61|0.8042
91515752|NCT04420221|182904855|OTHER||Vaccine Efficacy (VE)|-38.09|||||TWO_SIDED|95.0|-245.77|40.86|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||40.86|-245.77|
91515753|NCT04420221|182904856|OTHER||Vaccine Efficacy (VE)|-75.52|||||TWO_SIDED|95.0|-295.41|17.46|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||17.46|-295.41|
91515754|NCT01040130|182904860|SUPERIORITY_OR_OTHER||Ratio to placebo|1.14|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|1.065|1.221|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.221|1.065|0.0002
91515755|NCT01040130|182904860|SUPERIORITY_OR_OTHER||Ratio to placebo|1.138|STANDARD_ERROR_OF_MEAN|0.04||0.0003||95.0|1.062|1.219|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.219|1.062|0.0003
91515756|NCT01040130|182904861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.112|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.112|<0.0001
91515757|NCT01040130|182904861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.104|0.245|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.245|0.104|<0.0001
91515758|NCT01040130|182904862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.766|STANDARD_ERROR_OF_MEAN|0.223||0.0007||95.0|-1.205|-0.326|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.326|-1.205|0.0007
91515759|NCT01040130|182904862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.634|STANDARD_ERROR_OF_MEAN|0.225||0.0051||95.0|-1.077|-0.192|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.192|-1.077|0.0051
91515760|NCT01040130|182904863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.258|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.191|0.325|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.325|0.191|<0.0001
91579350|NCT02731690|183048221|SUPERIORITY|||||||0.6201||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6201
91579351|NCT02731690|183048221|SUPERIORITY|||||||0.9229||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.9229
91579352|NCT02731690|183048221|SUPERIORITY|||||||0.6307||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.6307
91579353|NCT02731690|183048222|SUPERIORITY|||||||0.0088||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0088
91579354|NCT02731690|183048222|SUPERIORITY|||||||0.2213||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.2213
91579355|NCT02731690|183048222|SUPERIORITY|||||||0.018||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0180
91579356|NCT02731690|183048222|SUPERIORITY|||||||0.197||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.1970
91579357|NCT02731690|183048223|SUPERIORITY|||||||0.0752||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0752
91579358|NCT02731690|183048223|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.6403||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6403
91579359|NCT02731690|183048223|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.2316||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.2316
91579360|NCT02731690|183048223|SUPERIORITY|||||||0.7635||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.7635
91579361|NCT02731690|183048224|SUPERIORITY|||||||0.0872||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0872
91579362|NCT02731690|183048224|SUPERIORITY|||||||0.0073||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0073
91579363|NCT02731690|183048224|SUPERIORITY|||||||0.0086||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0086
91579364|NCT02731690|183048224|SUPERIORITY|||||||0.0489||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0489
91579365|NCT00872989|183048226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.49|TWO_SIDED|80.0|0.79|1.26|||Regression, Cox|||||1.26|0.79|0.49
91579366|NCT00872989|183048228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.83|TWO_SIDED|80.0|0.93|1.68|||Regression, Cox|||||1.68|0.93|0.83
91579367|NCT03573583|183048275|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.03|TWO_SIDED|95.0|0.22|4.36||No formal adjustment for type I error due to the pilot nature of the study. All significance tests were 2-tailed and an alpha level of 0.05 was required for significance.|ANCOVA|Adjusted for baseline score.||Continuous variables were expressed as mean (SD) and categorical variables were as frequencies and percentages. A 2-sided independent-sample t test was used to compare group differences in change scores. Change scores were calculated as Week 16 measurements minus baseline measurements. Statistical analyses were done by a blinded statistician without knowledge of group membership.||4.36|0.22|0.03
91579368|NCT03573583|183048276|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.009|TWO_SIDED|95.0|0.31|1.77|||ANCOVA|Adjusted for baseline score.||||1.77|0.31|0.009
91579369|NCT03573583|183048277|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.07|TWO_SIDED|95.0|-0.1|2.67|||ANCOVA|Baseline as covariate||||2.67|-0.10|0.07
91579370|NCT03573583|183048278|OTHER|Pearson's correlation coefficients, along with their 95% confidence intervals (CIs)|Pearson's Correlation coefficient|0.19||||0.49|TWO_SIDED|95.0|-0.35|0.64|||Pearson's Correlation coefficient|||||0.64|-0.35|0.49
91579371|NCT02915302|183048302|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was \<5%.|Difference in Fever Rate|0.84|||||TWO_SIDED|95.0|-2.13|3.8|||||Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)|Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.||3.80|-2.13|
91579372|NCT02915302|183048303|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H1N1)|1.45|||||TWO_SIDED|95.0|1.19|1.77|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.77|1.19|
91579373|NCT02915302|183048303|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H3N2)|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.83|1.23|
91579374|NCT02915302|183048303|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Victoria lineage)|1.33|||||TWO_SIDED|95.0|1.1|1.62|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.62|1.10|
91579375|NCT02915302|183048303|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Yamagata lineage)|1.44|||||TWO_SIDED|95.0|1.2|1.73|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.73|1.20|
91579376|NCT02915302|183048304|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H1N1)|5.1|||||TWO_SIDED|95.0|0.189|10.0|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||10.0|0.189|
91579377|NCT02915302|183048304|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H3N2)|4.3|||||TWO_SIDED|95.0|-0.283|8.99|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||8.99|-0.283|
91579378|NCT02915302|183048304|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Victoria lineage)|1.4|||||TWO_SIDED|95.0|-2.78|5.56|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||5.56|-2.78|
91579379|NCT02915302|183048304|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Yamagata lineage)|3.4|||||TWO_SIDED|95.0|-0.465|7.36|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||7.36|-0.465|
91579380|NCT01639495|183048308|SUPERIORITY_OR_OTHER||Percentage of subjects|60.6|||||TWO_SIDED|95.0|51.9|68.8|||||The 2-sided 95% confidence intervals are based on exact binomial|||68.8|51.9|
91579381|NCT01639495|183048310|SUPERIORITY_OR_OTHER||Percentage of subjects with primary AEs|17.4|||||TWO_SIDED|95.0|11.6|24.6|||||The 2-sided 95% confidence interval is exact binomial|||24.6|11.6|
91579382|NCT01639495|183048311|SUPERIORITY_OR_OTHER||Percentage of subjects|97.2|||||TWO_SIDED|95.0|95.6|98.2|||||The 2-sided 95% confidence intervals are exact binomial|||98.2|95.6|
91579383|NCT02366468|183048318|NON_INFERIORITY|non-inferiority margin: -4 letters|Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-3.04|1.27|||ANCOVA|including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.||The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.||1.27|-3.04|0.002
91579384|NCT02366468|183048322|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.62|TWO_SIDED|95.0|-17.1|28.56|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||28.56|-17.10|0.620
91579385|NCT02366468|183048323|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.925|TWO_SIDED|95.0|-33.66|30.59|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||30.59|-33.66|0.925
91579386|NCT00359216|183048325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219||95.0|||||ANCOVA|||The p-value is obtained by F-test in ANCOVA to assess the treatment group difference in changes from baseline, adjusted for baseline.||||0.9219
91579387|NCT05540717|183048326|SUPERIORITY||relative difference (%)|-20.25||||0.00048|TWO_SIDED|95.0|-31.0|-9.49|||Mixed Models Analysis|||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-9.49|-31.0|0.00048
91515761|NCT01040130|182904863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.226|0.362|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.362|0.226|<0.0001
91515762|NCT01040130|182904864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.107|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.107|<0.0001
91579388|NCT05540717|183048327|SUPERIORITY||relative difference (%)|-20.2||||0.00032|TWO_SIDED|95.0|-30.13|-10.27|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-10.27|-30.13|0.00032
91579389|NCT05540717|183048328|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-26.54||||0.0008|TWO_SIDED|95.0|-41.15|-11.94|||Mixed Models Analysis|||Comparison of dMS of CSMS on peak GPS||-11.94|-41.15|0.00080
91579390|NCT05540717|183048328|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect.|relative difference (%)|-26.6||||0.00031|TWO_SIDED|95.0|-40.49|-12.72|||Mixed Models Analysis|||Comparison of dMS of CSMS on entire GPS||-12.72|-40.49|0.00031
91579391|NCT05540717|183048329|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.35||||0.00223|TWO_SIDED|95.0|-26.27|-6.44|||Mixed Models Analysis|||Comparison of dSS of CSMS on peak GPS||-6.44|-26.27|0.00223
91579392|NCT05540717|183048329|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.58||||0.00076|TWO_SIDED|95.0|||||Mixed Models Analysis|||Comparison of dSS of CSMS on entire GPS||||0.00076
91579393|NCT05540717|183048330|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.00032|TWO_SIDED|95.0|-0.76|-0.23|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect||Average Total RQLQ Score During Peak GPS||-0.23|-0.76|0.00032
91579394|NCT05540717|183048331|SUPERIORITY||Mean Difference (Final Values)|3.99|||<|1e-05|TWO_SIDED|95.0|3.28|4.7|||Mixed Models Analysis|||Change from baseline to Visit 7 of serum grass-specific IgG4 \[mg/L\]||4.7|3.28|<0.00001
91579395|NCT05540717|183048332|SUPERIORITY||Odds Ratio (OR)|1.254||||0.10846|TWO_SIDED|95.0|0.951|1.652|||Regression, Logistic|The probability of a well day was calculated using a generalized estimating equation (GEE) or similar approaches as appropriate.||Probability of Well Days During Peak (truncated) GPS||1.652|0.951|0.10846
91579396|NCT01144052|183048349|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed as this was a pilot study serving to generate first data and hypotheses.||||||0.125||95.0|||||Log Rank|||||||0.125
91579397|NCT01144052|183048350|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||non-parametric|||||||0.447
91579398|NCT01144052|183048351|SUPERIORITY_OR_OTHER|||||||0.447|||||||non-parametric|||||||0.447
91579399|NCT01144052|183048352|SUPERIORITY_OR_OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
91579400|NCT01144052|183048354|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed, as this was pilot study serving to generate first data and hypotheses.||||||0.234||95.0|||||Wilcoxon (Mann-Whitney)|p-value refers to nT2L at month 12||||||0.234
91579401|NCT00105001|183048357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.09
91579402|NCT00105001|183048357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.1|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[|||1.1|0.4|0.10
91579403|NCT00105001|183048357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62||||0.04|TWO_SIDED|95.0|0.6|1.0|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||1.0|0.6|0.04
91579404|NCT00105001|183048358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.55
91579405|NCT00105001|183048359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.009
91579406|NCT00105001|183048359|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.51|TWO_SIDED|95.0|0.5|1.4|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up|||1.4|0.5|0.51
91579407|NCT00105001|183048359|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.3|0.8|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||0.8|0.3|0.004
91579408|NCT00105001|183048360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.93
91579409|NCT00105001|183048361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.96
91579410|NCT00037830|183048400|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.||||<0.0001
91579411|NCT00037830|183048401|SUPERIORITY_OR_OTHER|||||||0.0368|||||||t-test, 2 sided|||The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.||||0.0368
91579412|NCT00037830|183048402|SUPERIORITY_OR_OTHER|||||||0.1903|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.1903
91579413|NCT00037830|183048402|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0063
91579414|NCT00037830|183048403|SUPERIORITY_OR_OTHER|||||||0.0502|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.0502
91579415|NCT00037830|183048403|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0003
91579416|NCT00037830|183048404|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91579417|NCT00037830|183048405|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||||||0.1310
91579418|NCT00037830|183048406|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Analysis was paired sample t-test on change from baseline.||||<0.05
91579419|NCT00037830|183048407|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91579420|NCT00037830|183048408|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91579421|NCT00037830|183048409|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91579422|NCT00127205|183048410|OTHER|||||||0.49|||||||Log Rank|||||||0.49
91515763|NCT01040130|182904864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.064|0.21|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.210|0.064|0.0003
91515764|NCT01040130|182904865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.051||0.0447||95.0|-0.204|-0.002|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.002|-0.204|0.0447
91515765|NCT01040130|182904865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.052||0.2132||95.0|-0.166|0.037|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.037|-0.166|0.2132
91515766|NCT01040130|182904866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.154||0.5698||95.0|-0.391|0.216|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.216|-0.391|0.5698
91515767|NCT01040130|182904866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.155||0.1003||95.0|-0.05|0.561|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.561|-0.050|0.1003
91515768|NCT01040130|182904867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.069||0.0784||95.0|-0.258|0.014|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.014|-0.258|0.0784
91515769|NCT01040130|182904867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.07||0.1013||95.0|-0.252|0.023|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.023|-0.252|0.1013
91515770|NCT01040130|182904868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.066||0.0015||95.0|-0.339|-0.081|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.081|-0.339|0.0015
91515771|NCT01040130|182904868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|-0.503|-0.243|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.243|-0.503|<0.0001
91515772|NCT01040130|182904869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.034||0.0005||95.0|0.052|0.185|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.185|0.052|0.0005
91515773|NCT01040130|182904869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0073||95.0|0.025|0.159|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.159|0.025|0.0073
91515774|NCT01040130|182904870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.136|0.275|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.275|0.136|<0.0001
91515775|NCT01040130|182904870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.146|0.285|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.285|0.146|<0.0001
91515776|NCT01040130|182904871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.9239||95.0|-0.115|0.127|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.127|-0.115|0.9239
91515777|NCT01040130|182904871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.062||0.7368||95.0|-0.144|0.102|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.102|-0.144|0.7368
91515778|NCT01040130|182904872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.067||0.8302||95.0|-0.146|0.118|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.118|-0.146|0.8302
91515779|NCT01040130|182904872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.068||0.0202||95.0|-0.292|-0.025|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.025|-0.292|0.0202
91515780|NCT01040130|182904873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.056|0.123|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.123|0.056|<0.0001
91515781|NCT01040130|182904873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.068|0.134|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.134|0.068|<0.0001
91515782|NCT01040130|182904874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.191|0.258|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.258|0.191|<0.0001
91515783|NCT01040130|182904874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.193|0.259|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.259|0.193|<0.0001
91515784|NCT01040130|182904875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.031||0.0006||95.0|0.046|0.167|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.167|0.046|0.0006
91515785|NCT01040130|182904875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.031||0.0017||95.0|0.037|0.158|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.158|0.037|0.0017
91579423|NCT00127205|183048410|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.24|TWO_SIDED|95.0|0.94|1.26|||Regression, Cox|||||1.26|0.94|0.24
91579424|NCT00127205|183048410|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5|TWO_SIDED|95.0|0.9|1.24|||Regression, Cox|||||1.24|0.90|0.50
91579425|NCT00127205|183048411|OTHER|||||||0.5|||||||Log Rank|||||||0.50
91579426|NCT00127205|183048412|OTHER|||||||0.93|||||||Log Rank|||Statistical analysis for recurrence to bone||||0.93
91515786|NCT01040130|182904876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.227|0.342|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.342|0.227|<0.0001
91515787|NCT01040130|182904876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.233|0.348|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.348|0.233|<0.0001
91515788|NCT01040130|182904877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.207|0.429|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.429|0.207|<0.0001
91515789|NCT01040130|182904877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.192|0.414|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.414|0.192|<0.0001
91515790|NCT01040130|182904878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.585|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.47|0.701|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.701|0.470|<0.0001
91515791|NCT01040130|182904878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.618|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001||95.0|0.502|0.734|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.734|0.502|<0.0001
91515792|NCT01866410|182904906|OTHER|||||||0.4|||||||Log Rank|||||||0.4
91515793|NCT01866410|182904907|OTHER|||||||0.5|||||||Log Rank|||||||0.5
91515794|NCT00553267|182904910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001||95.0|-3.77|-1.75||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.75|-3.77|<0.0001
91515795|NCT00553267|182904910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001||95.0|-3.86|-1.84||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.84|-3.86|<0.0001
91515796|NCT00553267|182904911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.15|-2.16|||ANCOVA|Adjusted for baseline and country effect||||-2.16|-5.15|<0.0001
91515797|NCT00553267|182904911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.35|-2.36|||ANCOVA|Adjusted for baseline and country effect||||-2.36|-5.35|<0.0001
91515798|NCT00553267|182904912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002|TWO_SIDED|95.0|1.21|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.21|0.002
91515799|NCT00553267|182904912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||<|0.001||95.0|1.37|2.65|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.65|1.37|<0.001
91515800|NCT00553267|182904913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004||95.0|1.3|4.25|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.25|1.30|0.004
91515801|NCT00553267|182904913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.004||95.0|1.29|4.22|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.22|1.29|0.004
91515802|NCT00553267|182904914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.002||95.0|1.21|2.34|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.34|1.21|0.002
91515803|NCT00553267|182904914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||<|0.001||95.0|1.38|2.68|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.68|1.38|<0.001
91515804|NCT00553267|182904915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.027||95.0|1.04|2.0|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.00|1.04|0.027
91515805|NCT00553267|182904915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.008||95.0|1.12|2.15|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.15|1.12|0.008
91515806|NCT00553267|182904916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.006||95.0|1.14|2.21|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.21|1.14|0.006
91515807|NCT00553267|182904916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002||95.0|1.2|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.20|0.002
91515808|NCT00553267|182904917|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||0.006
91515809|NCT00553267|182904917|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||<0.001
91515810|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.03|0.92|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 4||0.92|-0.03|
91515811|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|95.0|0.25|1.13|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.13|0.25|
91515812|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|95.0|-0.2|0.8|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.80|-0.20|
91515813|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|-0.24|0.95|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||0.95|-0.24|
91515814|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.279|||TWO_SIDED|95.0|-0.05|1.09|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg- Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||1.09|-0.05|
91515815|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|-0.61|0.69|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||0.69|-0.61|
91515816|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|95.0|0.15|1.11|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.11|0.15|
91515817|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|-0.06|0.86|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||0.86|-0.06|
91515818|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|-0.29|0.77|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||0.77|-0.29|
91515819|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.1|1.12|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 7||1.12|0.10|
91515820|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|95.0|0.09|1.08|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||1.08|0.09|
91515821|NCT00833989|182904960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|-0.39|0.73|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||0.73|-0.39|
91515822|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.981|||TWO_SIDED|95.0|-0.6|19.71|||Mixed Model Repeated Measures Analysis||Mean difference =GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 4||19.71|-0.60|
91515823|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.47|STANDARD_ERROR_OF_MEAN|4.801|||TWO_SIDED|95.0|-1.32|18.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||18.26|-1.32|
91515824|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|5.47|||TWO_SIDED|95.0|-11.1|11.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.24|-11.1|
91515825|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.58|STANDARD_ERROR_OF_MEAN|5.631|||TWO_SIDED|95.0|0.01|23.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||23.15|0.01|
91515826|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.77|STANDARD_ERROR_OF_MEAN|5.411|||TWO_SIDED|95.0|-2.35|19.89|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||19.89|-2.35|
91515827|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|6.195|||TWO_SIDED|95.0|-12.2|13.21|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||13.21|-12.2|
91515828|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.66|STANDARD_ERROR_OF_MEAN|5.351|||TWO_SIDED|95.0|-1.34|20.66|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||20.66|-1.34|
91515829|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.45|STANDARD_ERROR_OF_MEAN|5.198|||TWO_SIDED|95.0|-3.22|18.13|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||18.13|-3.22|
91515830|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.63|STANDARD_ERROR_OF_MEAN|5.959|||TWO_SIDED|95.0|-22.9|1.6|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.60|-22.9|
91515831|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|6.134|||TWO_SIDED|95.0|-3.07|22.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 7||22.24|-3.07|
91515832|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.89|STANDARD_ERROR_OF_MEAN|5.948|||TWO_SIDED|95.0|-6.37|18.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||18.15|-6.37|
91515833|NCT00833989|182904961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|6.768|||TWO_SIDED|95.0|-17.1|10.84|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 7||10.84|-17.1|
91515834|NCT00833989|182904962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|7.047|||TWO_SIDED|95.0|-15.81|12.86|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||12.86|-15.81|
91515835|NCT00833989|182904962|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.86|STANDARD_ERROR_OF_MEAN|6.852|||TWO_SIDED|95.0|-4.08|23.8|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||23.80|-4.08|
91515836|NCT00833989|182904962|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|7.376|||TWO_SIDED|95.0|-20.41|9.6|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||9.60|-20.41|
91579427|NCT03377699|183048428|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.31|0.08|||ANCOVA|||Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.08|-0.31|<0.0001
91579428|NCT03377699|183048428|EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.08||||0.3881|TWO_SIDED|95.0|-0.27|0.11|||ANCOVA|||Secondary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.11|-0.27|0.3881
91579429|NCT02580305|183048461|SUPERIORITY|||||||0.41||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.41
91579430|NCT02580305|183048461|SUPERIORITY|||||||0.9||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.90
91579431|NCT02580305|183048462|SUPERIORITY|||||||0.46||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.46
91579432|NCT02580305|183048462|SUPERIORITY|||||||0.48||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.48
91579433|NCT02580305|183048463|SUPERIORITY|||||||0.83||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.83
91579434|NCT02580305|183048463|SUPERIORITY|||||||0.24||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.24
91515837|NCT00833989|182904962|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|10.04|||TWO_SIDED|95.0|-22.87|18.07|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||18.07|-22.87|
91515838|NCT00833989|182904962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.03|STANDARD_ERROR_OF_MEAN|10.31|||TWO_SIDED|95.0|-15.95|26.0|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||26.00|-15.95|
91579435|NCT02580305|183048464|SUPERIORITY|||||||0.17||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.17
91579436|NCT02580305|183048464|SUPERIORITY|||||||0.14||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.14
91579437|NCT02580305|183048465|SUPERIORITY|||||||0.79||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.79
91579438|NCT02580305|183048465|SUPERIORITY|||||||0.92||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.92
91579439|NCT03582943|183048466|SUPERIORITY|A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.|Mean Difference (Net)|0.74||||0.984|TWO_SIDED|||||Test of differences between groups.|Mixed Models Analysis|||||||0.984
91579440|NCT03582943|183048466|SUPERIORITY||Mean Difference (Net)|-0.023||||0.455|TWO_SIDED|||||Test of interaction between age and RLIC vs. sham|Mixed Models Analysis|||||||.455
91579441|NCT03582943|183048466|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.803|TWO_SIDED|||||Test of interaction between sex and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.803
91579442|NCT03582943|183048466|SUPERIORITY||Mean Difference (Net)|0.25||||0.233|TWO_SIDED|||||Test of interaction between BMI and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.233
91579443|NCT03582943|183048466|SUPERIORITY|Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning|Mean Difference (Net)|4.12||||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
91579444|NCT01177800|183048525|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91579445|NCT01177800|183048526|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 10: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
91579446|NCT01177800|183048527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
91579447|NCT01177800|183048528|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 26: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
91579448|NCT04587752|183048543|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
91579449|NCT04587752|183048544|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
91579450|NCT04587752|183048545|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
91579451|NCT01232738|183048546|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.07|TWO_SIDED|95.0|-0.53|0.02|||Chi-squared|||Difference in slope of decline||0.02|-0.53|0.07
91579452|NCT01232738|183048547|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
91579453|NCT03231800|183048566|SUPERIORITY||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.059|<|0.001|TWO_SIDED|95.0|-7.351|-3.137|||ANCOVA|||Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.||-3.137|-7.351|<0.001
91579454|NCT03231800|183048569|SUPERIORITY||Mean Difference (Final Values)|13.86|STANDARD_ERROR_OF_MEAN|5.612||0.016|TWO_SIDED|95.0|2.694|25.017|||ANCOVA|||||25.017|2.694|0.016
91579455|NCT03231800|183048570|SUPERIORITY||Mean Difference (Final Values)|12.06|STANDARD_ERROR_OF_MEAN|5.508||0.031|TWO_SIDED|95.0|1.105|23.017|||ANCOVA|||||23.017|1.105|0.031
91515839|NCT00833989|182904962|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|10.916|||TWO_SIDED|95.0|-32.29|12.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.15|-32.29|
91515840|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|5.147|||TWO_SIDED|95.0|-10.4|10.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||10.61|-10.4|
91515841|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.75|STANDARD_ERROR_OF_MEAN|5.157|||TWO_SIDED|95.0|-7.75|13.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||13.26|-7.75|
91515842|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.85|STANDARD_ERROR_OF_MEAN|5.409|||TWO_SIDED|95.0|-6.17|15.88|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||15.88|-6.17|
91515843|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|6.504|||TWO_SIDED|95.0|-12.1|14.45|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 5||14.45|-12.1|
91515844|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|6.426|||TWO_SIDED|95.0|-11.0|15.12|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 5||15.12|-11.0|
91515845|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-16.1|11.68|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 5||11.68|-16.1|
91515846|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|6.664|||TWO_SIDED|95.0|-12.9|14.18|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||14.18|-12.9|
91515847|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|6.595||||95.0|-12.4|14.43|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||14.43|-12.4|
91515848|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-15.2|13.32|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||13.32|-15.2|
91515849|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|6.953|||TWO_SIDED|95.0|-11.9|16.4|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 7||16.40|-11.9|
91515850|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.52|STANDARD_ERROR_OF_MEAN|6.909|||TWO_SIDED|95.0|-10.5|17.55|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 7||17.55|-10.5|
91515851|NCT00833989|182904963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|7.328|||TWO_SIDED|95.0|-15.4|14.39|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 7||14.39|-15.4|
91515852|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-5.33|8.65|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||8.65|-5.33|
91515853|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-7.56|6.96|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||6.96|-7.56|
91515854|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.534|||TWO_SIDED|95.0|-2.67|11.78|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.78|-2.67|
91515855|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|3.841|||TWO_SIDED|95.0|-5.78|9.89|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 5||9.89|-5.78|
91515856|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.35|STANDARD_ERROR_OF_MEAN|3.958|||TWO_SIDED|95.0|-10.4|5.72|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 5||5.72|-10.4|
91515857|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44|STANDARD_ERROR_OF_MEAN|3.978|||TWO_SIDED|95.0|-6.68|9.55|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 5||9.55|-6.68|
91579456|NCT01480219|183048588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.96|||Regression, Cox|||Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.||2.96|1.02|0.042
91579457|NCT01480219|183048588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.453|TWO_SIDED|95.0|0.71|2.14|||Regression, Cox|||HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.||2.14|0.71|0.453
91579458|NCT01416389|183048628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||t-test, 1 sided|||This measure is compared between two treatment arms using a one-sided t-test. This measure followed a normal distribution.||||0.344
91579459|NCT01416389|183048629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|||||||Chi-squared|||||||0.608
91579460|NCT01416389|183048631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Chi-squared|||||||0.365
91579461|NCT01151410|183048646|NON_INFERIORITY_OR_EQUIVALENCE|Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.|Mean Difference (Net)|0.31||||0.004|ONE_SIDED|95.0|-2.4||||ANCOVA||||||-2.40|0.0040
91579462|NCT01253018|183048649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||"Sample size and power calculations were performed based on the difference in the FM score between the two groups with an assumed within group SD of 15.9, the correlation of 0.5 among repeated measures. 30 subjects enrolled in each arm of the study would give 80% power for detecting a difference of 8 points on the FM.~Two sample t-tests were conducted to compare changes in FM between the two interventions groups at final training (12 week)."||||<0.05
91579463|NCT01253018|183048649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in FM between the two interventions groups at retention (24 weeks).||||<0.05
91579464|NCT01253018|183048651|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at final training 12 week.||||<0.05
91579465|NCT01253018|183048651|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at retention 24 weeks.||||<0.05
91579466|NCT01253018|183048652|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at final training week 12.||||<0.05
91579467|NCT01253018|183048652|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at retention week 24.||||<0.05
91579468|NCT00548262|183048663|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Success at EOT||73.6|44.6|
91579469|NCT00548262|183048664|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|EIVT Success||73.6|44.6|
91579470|NCT00548262|183048664|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Week 2 Follow-up Success||62.5|33.0|
91579471|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
91579472|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|0.0|100.0|||||95% CI based on normal approximation to the binomial.|Candida famata: Success||100.0|0.0|
91579473|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
91579474|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
91579475|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
91579476|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
91579477|NCT00548262|183048665|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
91579478|NCT00548262|183048666|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
91579479|NCT00548262|183048666|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
91579480|NCT00548262|183048666|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
91579481|NCT00548262|183048666|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
91579482|NCT00548262|183048666|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
91579483|NCT00548262|183048666|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
91579484|NCT00548262|183048667|SUPERIORITY_OR_OTHER||percentage of participants with success|47.6|||||TWO_SIDED|95.0|26.3|69.0|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||69.0|26.3|
91579485|NCT00548262|183048667|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
91579486|NCT00548262|183048667|SUPERIORITY_OR_OTHER||percentage of participants with success|70.0|||||TWO_SIDED|95.0|41.6|98.4|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||98.4|41.6|
91579487|NCT00548262|183048667|SUPERIORITY_OR_OTHER||percentage of participants with success|28.6|||||TWO_SIDED|95.0|0.0|62.0|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||62.0|0.0|
91579488|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
91579489|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
91579490|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
91579491|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
91579492|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
91579493|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
91579494|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
91579495|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
91579496|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
91579497|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|67.7|||||TWO_SIDED|95.0|51.3|84.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||84.2|51.3|
91579498|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
91579499|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
91579500|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|57.9|||||TWO_SIDED|95.0|35.7|80.1|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||80.1|35.7|
91579501|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|60.0|||||TWO_SIDED|95.0|40.8|79.2|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||79.2|40.8|
91579502|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
91579503|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
91579504|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
91579505|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
91579506|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|20.0|||||TWO_SIDED|95.0|0.0|55.1|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||55.1|0.0|
91579507|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|64.1|||||TWO_SIDED|95.0|49.0|79.2|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||79.2|49.0|
91579508|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|21.7|78.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||78.3|21.7|
91579509|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|62.5|||||TWO_SIDED|95.0|45.7|79.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||79.3|45.7|
91579510|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
91579511|NCT00548262|183048668|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
91579512|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
91579513|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
91579514|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
91579515|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
91579516|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
91579517|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
91579518|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
91579519|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
91579520|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|46.2|||||TWO_SIDED|95.0|19.1|73.3|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||73.3|19.1|
91579521|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|64.5|||||TWO_SIDED|95.0|47.7|81.4|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||81.4|47.7|
91579522|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
91579523|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
91579524|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|63.2|||||TWO_SIDED|95.0|41.5|84.8|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||84.8|41.5|
91579525|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|56.0|||||TWO_SIDED|95.0|36.5|75.5|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||75.5|36.5|
91579526|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
91579527|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
91579528|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
91579529|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
91579530|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
91579531|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|61.5|||||TWO_SIDED|95.0|46.3|76.8|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||76.8|46.3|
91579532|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|58.3|||||TWO_SIDED|95.0|30.4|86.2|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||86.2|30.4|
91579533|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|59.4|||||TWO_SIDED|95.0|42.4|76.4|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||76.4|42.4|
91579534|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
91579535|NCT00548262|183048669|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
91579536|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|37.5|||||TWO_SIDED|95.0|20.7|54.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||54.3|20.7|
91579537|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|75.0|||||TWO_SIDED|95.0|50.5|99.5|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||99.5|50.5|
91579538|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|39.4|||||TWO_SIDED|95.0|22.7|56.1|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||56.1|22.7|
91579539|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
91579540|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||64.4|33.0|
91579541|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||82.9|0.0|
91579542|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|47.4|||||TWO_SIDED|95.0|31.5|63.2|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||63.2|31.5|
91579543|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|10.0|90.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||90.0|10.0|
91579544|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
91579545|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|51.6|||||TWO_SIDED|95.0|34.0|69.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||69.2|34.0|
91579546|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||40.2|0.0|
91579547|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||70.1|38.0|
91579548|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|42.1|||||TWO_SIDED|95.0|19.9|64.3|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||64.3|19.9|
91579549|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|52.0|||||TWO_SIDED|95.0|32.4|71.6|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||71.6|32.4|
91579550|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||62.5|33.0|
91579551|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||40.2|0.0|
91579552|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||70.1|38.0|
91579553|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|46.5|||||TWO_SIDED|95.0|31.6|61.4|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||61.4|31.6|
91579554|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
91579555|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||64.4|33.0|
91579556|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|41.7|||||TWO_SIDED|95.0|13.8|69.6|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||69.6|13.8|
91579557|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|32.7|67.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||67.3|32.7|
91579558|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
91579559|NCT00548262|183048670|SUPERIORITY_OR_OTHER||percentage of participants with success|51.7|||||TWO_SIDED|95.0|33.5|69.9|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||69.9|33.5|
91579560|NCT00548262|183048671|SUPERIORITY_OR_OTHER||percentage of participants with success|68.6|||||TWO_SIDED|95.0|53.2|84.0|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EIVT): Success||84.0|53.2|
91579561|NCT00548262|183048671|SUPERIORITY_OR_OTHER||percentage of participants with success|22.2|||||TWO_SIDED|95.0|0.0|49.4|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EIVT): Success||49.4|0.0|
91579562|NCT00548262|183048671|SUPERIORITY_OR_OTHER||percentage of participants with success|71.4|||||TWO_SIDED|95.0|56.5|86.4|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EOT): Success||86.4|56.5|
91579563|NCT00548262|183048671|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EOT): Success||31.6|0.0|
91579564|NCT00548262|183048671|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|40.7|73.5|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (Week 2 F/U): Success||73.5|40.7|
91579565|NCT00548262|183048671|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (Week 2 F/U): Success||31.6|0.0|
91579566|NCT00969709|183048708|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.23||||0.0186|TWO_SIDED|95.0|-5.92|-0.54|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.54|-5.92|0.0186
91579567|NCT00969709|183048708|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.0038|TWO_SIDED|95.0|-6.69|-1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.29|-6.69|0.0038
91579568|NCT00969709|183048708|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.86||||0.0005|TWO_SIDED|95.0|-7.59|-2.12|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-2.12|-7.59|0.0005
91579569|NCT00969709|183048709|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.41||||0.1687|TWO_SIDED|95.0|-3.42|0.6|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||0.60|-3.42|0.1687
91579570|NCT00969709|183048709|SUPERIORITY_OR_OTHER||least squares mean difference|-2.51||||0.0151|TWO_SIDED|95.0|-4.54|-0.49|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.49|-4.54|0.0151
91579571|NCT00969709|183048709|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.57||||0.0141|TWO_SIDED|95.0|-4.62|-0.52|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.52|-4.62|0.0141
91579572|NCT02516332|183048720|OTHER|||||||0.038|||||||ANCOVA|||||||0.038
91579573|NCT02516332|183048720|OTHER|||||||0.002|||||||ANCOVA|||||||0.002
91579574|NCT02516332|183048725|OTHER|||||||0.011|||||||Regression, Linear|||||||0.011
91579575|NCT02516332|183048725|OTHER|||||||0.036|||||||Regression, Linear|||||||0.036
91579576|NCT02217332|183048731|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 6 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'.||||< 0.001
91579577|NCT02217332|183048732|SUPERIORITY|||||||0.885||||||Month 6/LOCF was used for the analysis of change from Baseline to Month 6 within the dexpramipexole group.|t-test, 2 sided|||||||0.885
91579578|NCT02217332|183048736|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 3 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 3 to Baseline within the dexpramipexole group equals '1'.||||<.001
91579579|NCT02217332|183048737|SUPERIORITY|||||||1||||||Month 3/LOCF was used for the analysis of change from Baseline to Month 3 within the dexpramipexole group.|t-test, 2 sided|Paired t-test comparing baseline to month 3 within the dexpramipexole treatment group||||||1.0
91579580|NCT02217332|183048738|SUPERIORITY||log scale|||||0.001|||||||Wilcoxon Signed Rank Test (paired)|||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'; 68% confidence interval is equal to plus/minus 1 standard error||||0.001
91579581|NCT02914275|183048749|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% confidence interval (CI) of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.88||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||0.88|0.72|
91579582|NCT02914275|183048749|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.27|||||TWO_SIDED|95.0|1.15|1.42||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.42|1.15|
91579583|NCT02914275|183048749|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.12|||||TWO_SIDED|95.0|1.01|1.24||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.24|1.01|
91579584|NCT02914275|183048749|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.09|0.86|
91579585|NCT02914275|183048750|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|-10.3|||||TWO_SIDED|95.0|-15.4|-5.1||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||-5.1|-15.4|
91579586|NCT02914275|183048750|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|2.6|||||TWO_SIDED|95.0|-2.54|7.8||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||7.8|-2.54|
91579587|NCT02914275|183048750|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|3.1|||||TWO_SIDED|95.0|-2.1|8.2||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||8.2|-2.1|
91579588|NCT02914275|183048750|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|0.9|||||TWO_SIDED|95.0|-4.2|6.1||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||6.1|-4.2|
91579589|NCT00923260|183048759|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
91579590|NCT00923260|183048760|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
91579591|NCT00923260|183048761|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
91579592|NCT00923260|183048762|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||.86
91579593|NCT00923260|183048763|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
91579594|NCT00923260|183048764|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
91579595|NCT00923260|183048765|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
91579596|NCT00923260|183048766|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||0.81
91579597|NCT00923260|183048767|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
91579598|NCT00923260|183048768|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
91579599|NCT00923260|183048769|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||||||0.15
91579600|NCT00923260|183048770|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.20
91579601|NCT00923260|183048771|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
91579602|NCT00923260|183048772|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
91579603|NCT00923260|183048773|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
91579604|NCT00923260|183048774|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
91579605|NCT00923260|183048775|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
91579606|NCT00923260|183048776|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||||||0.33
91579607|NCT00923260|183048777|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
91579608|NCT00923260|183048778|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
91579609|NCT00923260|183048779|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
91579610|NCT00923260|183048780|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
91579611|NCT00923260|183048781|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
91579612|NCT00923260|183048782|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
91579613|NCT00923260|183048783|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 2 sided|||||||0.67
91579614|NCT00923260|183048784|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
91579615|NCT00923260|183048785|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
91579616|NCT00923260|183048786|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||||||0.14
91579617|NCT00923260|183048787|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
91579618|NCT00923260|183048788|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
91579619|NCT00923260|183048789|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
91579620|NCT00923260|183048790|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
91579621|NCT00923260|183048791|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
91579622|NCT00923260|183048792|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
91579623|NCT00923260|183048793|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.40
91579624|NCT00923260|183048794|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
91579625|NCT00923260|183048795|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
91579626|NCT00923260|183048796|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
91579627|NCT00923260|183048797|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||t-test, 2 sided|||||||0.99
91579628|NCT00923260|183048798|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
91579629|NCT00923260|183048799|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
91579630|NCT00923260|183048800|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
91579631|NCT00923260|183048801|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||||||0.85
91579632|NCT00923260|183048802|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
91579633|NCT00923260|183048803|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.55
91579634|NCT00923260|183048804|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
91579635|NCT00923260|183048805|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
91579636|NCT00923260|183048806|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
91579637|NCT00923260|183048807|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||t-test, 2 sided|||||||0.87
91579638|NCT00923260|183048808|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||||||0.28
91579639|NCT00923260|183048809|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
91579640|NCT00923260|183048810|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
91579641|NCT00923260|183048811|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
91579642|NCT00923260|183048812|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||||||0.68
91579643|NCT00923260|183048813|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
91579644|NCT00923260|183048814|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
91579645|NCT00923260|183048815|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 2 sided|||||||0.32
91579646|NCT00923260|183048816|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
91579647|NCT00923260|183048817|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||t-test, 2 sided|||||||0.52
91579648|NCT00923260|183048818|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
91579649|NCT00923260|183048819|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
91579650|NCT00923260|183048820|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
91579651|NCT00923260|183048821|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
91579652|NCT00923260|183048822|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
91579653|NCT03828747|183048855|SUPERIORITY||Least Squares Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.849||0.0008|TWO_SIDED|95.0|-4.56|-1.21|||Mixed Models Analysis|||Change from Baseline at Week 49||-1.21|-4.56|0.0008
91579654|NCT03828747|183048855|SUPERIORITY||Least Squares Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.287||0.0351|TWO_SIDED|95.0|-5.31|-0.2|||Mixed Models Analysis|||Change from Baseline at Week 61||-0.20|-5.31|0.0351
91579655|NCT03828747|183048856|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.295||0.5207||95.0|-3.39|1.72|||Mixed Models Analysis|||Change from Baseline at Week 49||1.72|-3.39|0.5207
91579656|NCT03828747|183048856|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.911||0.3704||95.0|-5.5|2.07|||Mixed Models Analysis|||Change from Baseline at Week 61||2.07|-5.50|0.3704
91579657|NCT03828747|183048857|SUPERIORITY||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.282||0.3501||95.0|-0.29|0.82|||Mixed Models Analysis|||Change from Baseline at Week 49||0.82|-0.29|0.3501
91579658|NCT03828747|183048857|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.525||0.7431|TWO_SIDED|95.0|-0.87|1.22|||Mixed Models Analysis|||Change from Baseline at Week 61||1.22|-0.87|0.7431
91579659|NCT03828747|183048858|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.429||0.5366||95.0|-0.58|1.11|||Mixed Models Analysis|||Change from Baseline at Week 49||1.11|-0.58|0.5366
91579660|NCT03828747|183048858|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.618||0.0851||95.0|-0.15|2.3|||Mixed Models Analysis|||Change from Baseline at Week 61||2.30|-0.15|0.0851
91579661|NCT04187989|183048886|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.006|STANDARD_ERROR_OF_MEAN|0.239||0.98|TWO_SIDED|95.0|-0.478|0.466|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.466|-.478|.980
91579662|NCT04187989|183048887|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.265|STANDARD_ERROR_OF_MEAN|0.18||0.14|TWO_SIDED|95.0|-0.092|0.621||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.621|-.092|.140
91579663|NCT04187989|183048889|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.064|STANDARD_ERROR_OF_MEAN|0.181||0.724|TWO_SIDED|95.0|-0.294|0.421||Two-sided test of the null hypothesis of no difference between groups|t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.421|-.294|.724
91515858|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.46|STANDARD_ERROR_OF_MEAN|4.109|||TWO_SIDED|95.0|-4.94|11.85|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 6||11.85|-4.94|
91515859|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|4.235|||TWO_SIDED|95.0|-8.15|9.12|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 6||9.12|-8.15|
91515860|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|4.28|||TWO_SIDED|95.0|-7.97|9.5|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 6||9.50|-7.97|
91515861|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|4.205|||TWO_SIDED|95.0|-5.53|11.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||11.61|-5.53|
91515862|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|STANDARD_ERROR_OF_MEAN|4.376|||TWO_SIDED|95.0|-11.5|6.32|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||6.32|-11.5|
91515863|NCT00833989|182904964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73|STANDARD_ERROR_OF_MEAN|4.396|||TWO_SIDED|95.0|-5.22|12.69|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.69|-5.22|
91515864|NCT00833989|182904965|SUPERIORITY_OR_OTHER|||||||0.926|||||||Fisher Exact|||Visit 4||||0.9260
91515865|NCT00833989|182904965|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Fisher Exact|||Visit 6||||0.5647
91515866|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.896|||TWO_SIDED|95.0|-3.17|0.49|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 3||0.49|-3.17|
91515867|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.861|||TWO_SIDED|95.0|-1.95|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 3||1.57|-1.95|
91515868|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|0.933|||TWO_SIDED|95.0|-4.83|-1.02|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 3||-1.02|-4.83|
91515869|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.868|||TWO_SIDED|95.0|-2.47|1.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 4||1.08|-2.47|
91515870|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.834|||TWO_SIDED|95.0|-1.98|1.44|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.44|-1.98|
91515871|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.904|||TWO_SIDED|95.0|-2.77|0.92|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.92|-2.77|
91515872|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-3.64|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.57|-3.64|
91515873|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-2.97|2.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||2.24|-2.97|
91515874|NCT00833989|182904966|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-0.66|1.408|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.408|-0.66|
91515875|NCT00833989|182904967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.46|STANDARD_ERROR_OF_MEAN|12.584|||TWO_SIDED|95.0|-6.11|45.04|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 4||45.04|-6.11|
91515876|NCT00833989|182904967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.99|STANDARD_ERROR_OF_MEAN|12.131|||TWO_SIDED|95.0|-3.66|45.64|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 4||45.64|-3.66|
91515877|NCT00833989|182904967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.79|STANDARD_ERROR_OF_MEAN|13.143|||TWO_SIDED|95.0|-14.9|38.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 4||38.50|-14.9|
91515878|NCT00833989|182904967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.71|STANDARD_ERROR_OF_MEAN|9.021|||TWO_SIDED|95.0|-2.63|34.06|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 6||34.06|-2.63|
91515879|NCT00833989|182904967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.56|STANDARD_ERROR_OF_MEAN|8.835|||TWO_SIDED|95.0|-6.38|29.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 6||29.50|-6.38|
91579664|NCT04187989|183048890|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.078|STANDARD_ERROR_OF_MEAN|0.175||0.656|TWO_SIDED|95.0|-0.425|0.269|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.269|-.425|.656
91579665|NCT04187989|183048891|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.339|STANDARD_ERROR_OF_MEAN|0.205||0.158|TWO_SIDED|95.0|-0.746|0.067||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|||0.067|-.746|.158
91579666|NCT04187989|183048892|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.143|STANDARD_ERROR_OF_MEAN|0.178||0.422|TWO_SIDED|95.0|-0.21|0.495|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.495|-.210|.422
91579667|NCT04187989|183048893|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.027|STANDARD_ERROR_OF_MEAN|0.179||0.882|TWO_SIDED|95.0|-0.328|0.381|||t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.381|-.328|.882
91579668|NCT04187989|183048894|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.197|STANDARD_ERROR_OF_MEAN|0.268||0.497|TWO_SIDED|95.0|-0.728|0.334||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.334|-.728|.497
91579669|NCT04187989|183048895|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.042|STANDARD_ERROR_OF_MEAN|0.18||0.813|TWO_SIDED|95.0|-0.398|0.313||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.313|-.398|.813
91579670|NCT04187989|183048896|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.034|STANDARD_ERROR_OF_MEAN|0.176||0.849|TWO_SIDED|95.0|-0.381|0.314||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.314|-.381|.849
91579671|NCT04187989|183048897|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.118|STANDARD_ERROR_OF_MEAN|0.247||0.667|TWO_SIDED|95.0|-0.607|0.371||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.371|-.607|.667
91579672|NCT04187989|183048898|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.342|STANDARD_ERROR_OF_MEAN|0.175||0.051|TWO_SIDED|95.0|-0.689|0.005|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.005|-.689|.051
91579673|NCT04187989|183048899|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.064|STANDARD_ERROR_OF_MEAN|0.176||0.714|TWO_SIDED|95.0|-0.412|0.284|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model||We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|.284|-.412|.714
91579674|NCT04187989|183048900|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.11|STANDARD_ERROR_OF_MEAN|0.212||0.603|TWO_SIDED|95.0|-0.531|0.311|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|: We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.311|-.531|.603
91579675|NCT04187989|183048901|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.162|STANDARD_ERROR_OF_MEAN|0.219||0.457|TWO_SIDED|95.0|-0.273|0.597|||Cohen's D|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.597|-.273|.457
91579676|NCT04187989|183048902|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.265|STANDARD_ERROR_OF_MEAN|0.212||0.209|TWO_SIDED|95.0|-0.686|0.156|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.156|-.686|.209
91579677|NCT04187989|183048903|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.107|STANDARD_ERROR_OF_MEAN|0.219||0.623|TWO_SIDED|95.0|-0.541|0.328|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.328|-.541|.623
91579678|NCT03507777|183048911|SUPERIORITY||||||<|0.0001|||||||Linear mixed model|||||||<0.0001
91579679|NCT03507777|183048912|SUPERIORITY|||||||0.2487|||||||A Cox regression model|||||||0.2487
91579680|NCT03507777|183048913|SUPERIORITY|||||||0.2952|||||||A Cox regression model|||||||0.2952
91579681|NCT00700427|183048925|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
91579682|NCT00700427|183048927|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
91579683|NCT00700427|183048928|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
91579684|NCT00700427|183048928|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||0.002
91579685|NCT00700427|183048928|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||0.009
91579686|NCT00700427|183048928|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||0.003
91579687|NCT00700427|183048929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
91579688|NCT00700427|183048929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||<0.001
91579689|NCT00700427|183048929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||<0.001
91579690|NCT00700427|183048929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||<0.001
91579691|NCT00700427|183048930|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
91579692|NCT00700427|183048931|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
91579693|NCT04075994|183048952|SUPERIORITY|||||||0.22||||||A priori threshold for statistical significance p\<0.05.|t-test, 2 sided|||Proportion of days covered assessed as a continuous measure (range 0-1) at 12 months between study arms adjusted for trial stratification factors (type of anticoagulant treatment). We determined that a sample size of 120 in the intervention group and 120 in the control group enables us to detect a minimum difference in PDC as small as 12.6% with 90% power. Power calculations assume use of 2-sided tests with 0.05 significance level.||||0.22
91579694|NCT01247285|183048958|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.81|||||TWO_SIDED|90.0|97.37|119.38|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||119.38|97.37|
91579695|NCT01247285|183048959|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.69|||||TWO_SIDED|90.0|92.9|109.14|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.14|92.90|
91579696|NCT01247285|183048960|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.77|||||TWO_SIDED|90.0|93.53|108.56|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.56|93.53|
91579697|NCT01247285|183048961|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.88|||||TWO_SIDED|90.0|98.53|111.64|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.64|98.53|
91579698|NCT01247285|183048962|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.64|||||TWO_SIDED|90.0|99.97|111.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.56|99.97|
91579699|NCT01247285|183048963|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.05|||||TWO_SIDED|90.0|94.76|107.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.77|94.76|
91579700|NCT01941719|183049009|EQUIVALENCE|This trial aims to show the enhanced education is no better and no worse than the standard education|Mean Difference (Final Values)|-0.1212||||0.077|TWO_SIDED|||||significance level set at 0.05|ANCOVA|At each follow-up point, multivariate ANCOVA models were used to test for significant changes from the baseline||A mixed-effect model with repeated measures is used to compare the difference of group over time.||||0.0770
91579701|NCT01941719|183049010|EQUIVALENCE|This trial aims to show the new treatment is no better and no worse||||||0.6638||||||The threshold of significance level set at 0.05|Mixed Models Analysis|||||||0.6638
91579702|NCT01941719|183049011|EQUIVALENCE|The test will compare the number of complications between the two groups|||||<|0.05|||||||ANOVA|||||||< 0.05
91579703|NCT01167452|183049012|SUPERIORITY_OR_OTHER||Slope|-0.74|STANDARD_DEVIATION|0.19||0.0004|TWO_SIDED||||||Regression, Linear|Multivariate adaptive regression spline (MARS) analysis||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed weight for each participant.||||0.0004
91579704|NCT01167452|183049012|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_DEVIATION|0.2|<|0.0001|TWO_SIDED||||||Regression, Linear|Multiple Adaptive Regression Spline (MARS)||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed body mass index for each participant.||||<0.0001
91579705|NCT00858364|183049044|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.83|1.01|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.01|0.83|
91579706|NCT00858364|183049044|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.83|1.0|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.00|0.83|
91579707|NCT00858364|183049044|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.07|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin)||||||0.070
91579708|NCT00858364|183049044|SUPERIORITY|||||||0.047|||||||Log Rank|Unstratified log rank test||||||0.047
91579709|NCT00858364|183049044|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.84|1.02||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.02|0.84|
91579710|NCT00858364|183049045|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.04|0.87|
91579711|NCT00858364|183049045|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.04|0.87|
91579712|NCT00858364|183049045|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.31|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||||||0.31
91515880|NCT00833989|182904967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.49|STANDARD_ERROR_OF_MEAN|9.641|||TWO_SIDED|95.0|-27.1|12.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 6||12.08|-27.1|
91515881|NCT00833989|182904968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.849|||TWO_SIDED|95.0|-4.12|3.43|||ANCOVA||Mean difference= GSK249320 1 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 1 mg/kg, Visit 6||3.43|-4.12|
91515882|NCT00833989|182904968|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-3.96|3.62|||ANCOVA||Mean difference= GSK249320 5 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 5 mg/kg, Visit 6||3.62|-3.96|
91515883|NCT00833989|182904968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|STANDARD_ERROR_OF_MEAN|2.037|||TWO_SIDED|95.0|-5.31|3.01|||ANCOVA||Mean difference= GSK249320 15 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 15 mg/kg, Visit 6||3.01|-5.31|
91515884|NCT00833989|182904969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|1.408|||TWO_SIDED|95.0|-3.12|2.63|||ANCOVA||"Mean difference= GSK249320 1 mg/kg - Placebo.~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 1 mg/kg, Visit 6||2.63|-3.12|
91515885|NCT00833989|182904969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.55|STANDARD_ERROR_OF_MEAN|1.347|||TWO_SIDED|95.0|-1.2|4.3|||ANCOVA||"Mean difference= GSK249320 5 mg/kg - Placebo~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 5 mg/kg, Visit 6||4.30|-1.20|
91579713|NCT00858364|183049045|SUPERIORITY|||||||0.27|||||||Log Rank|Unstratified log rank test||||||0.27
91515886|NCT00833989|182904969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|1.486|||TWO_SIDED|95.0|-3.09|2.98|||ANCOVA||"Mean difference= GSK249320 15 mg/kg - Placebo.~Day 90 GDS Score= Treatment+Day 5 GDS Score"|Placebo Vs GSK249320 15 mg/kg, Visit 6||2.98|-3.09|
91515887|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.289|STANDARD_ERROR_OF_MEAN|0.2639|||TWO_SIDED|95.0|-0.841|0.264|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline|Stimulation Level 100%, Visit 4 Day 30||0.264|-0.841|
91515888|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|95.0|-0.862|0.241|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.241|-0.862|
91515889|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.303|STANDARD_ERROR_OF_MEAN|0.3172|||TWO_SIDED|95.0|-0.966|0.361|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.361|-0.966|
91515890|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1841|||TWO_SIDED|95.0|-0.184|0.593|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.593|-0.184|
91515891|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.1846|||TWO_SIDED|95.0|-0.284|0.494|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.494|-0.284|
91515892|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.416|STANDARD_ERROR_OF_MEAN|0.2602|||TWO_SIDED|95.0|-0.132|0.965|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.965|-0.132|
91515893|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.156|STANDARD_ERROR_OF_MEAN|0.8652|||TWO_SIDED|95.0|-0.65|2.961|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||2.961|-0.650|
91515894|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.518|STANDARD_ERROR_OF_MEAN|0.8324|||TWO_SIDED|95.0|-2.249|1.213|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.213|-2.249|
91515895|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.269|STANDARD_ERROR_OF_MEAN|1.0383|||TWO_SIDED|95.0|-2.436|1.898|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.898|-2.436|
91515896|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.806|STANDARD_ERROR_OF_MEAN|0.5862|||TWO_SIDED|95.0|-0.42|2.031|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||2.031|-0.420|
91515897|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.564|||TWO_SIDED|95.0|-1.183|1.168|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit"|Stimulation Level 110%, Visit 7 Day 112||1.168|-1.183|
91515898|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.506|STANDARD_ERROR_OF_MEAN|0.757|||TWO_SIDED|95.0|-0.064|3.077|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||3.077|-0.064|
91515899|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.644|STANDARD_ERROR_OF_MEAN|1.2976|||TWO_SIDED|95.0|-1.056|4.344|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||4.344|-1.056|
91515900|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231|STANDARD_ERROR_OF_MEAN|1.1762|||TWO_SIDED|95.0|-2.681|2.219|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.219|-2.681|
91515901|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.184|STANDARD_ERROR_OF_MEAN|1.4796|||TWO_SIDED|95.0|-3.279|2.91|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.910|-3.279|
91515902|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.622|STANDARD_ERROR_OF_MEAN|0.9746|||TWO_SIDED|95.0|-1.428|2.672|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||2.672|-1.428|
91515903|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.602|STANDARD_ERROR_OF_MEAN|0.934|||TWO_SIDED|95.0|-2.56|1.356|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||1.356|-2.560|
91515904|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.063|STANDARD_ERROR_OF_MEAN|1.281|||TWO_SIDED|95.0|-0.61|4.736|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||4.736|-0.610|
91515905|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.556|STANDARD_ERROR_OF_MEAN|1.4588|||TWO_SIDED|95.0|-1.494|4.607|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||4.607|-1.494|
91515906|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.531|STANDARD_ERROR_OF_MEAN|1.2336|||TWO_SIDED|95.0|-3.102|2.041|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||2.041|-3.102|
91515907|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.185|STANDARD_ERROR_OF_MEAN|1.5697|||TWO_SIDED|95.0|-3.471|3.101|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||3.101|-3.471|
91515908|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.686|STANDARD_ERROR_OF_MEAN|1.2689|||TWO_SIDED|95.0|-1.996|3.367|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||3.367|-1.996|
91515909|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|STANDARD_ERROR_OF_MEAN|1.0822|||TWO_SIDED|95.0|-2.838|1.726|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||1.726|-2.838|
91515910|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.219|STANDARD_ERROR_OF_MEAN|1.4792|||TWO_SIDED|95.0|-0.884|5.322|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||5.322|-0.884|
91515911|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.631|STANDARD_ERROR_OF_MEAN|1.589|||TWO_SIDED|95.0|-1.696|4.958|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||4.958|-1.696|
91515912|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.508|STANDARD_ERROR_OF_MEAN|1.2985|||TWO_SIDED|95.0|-3.219|2.203|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||2.203|-3.219|
91579714|NCT00858364|183049045|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.05|0.88|
91515913|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|1.6603|||TWO_SIDED|95.0|-3.369|3.588|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||3.588|-3.369|
91515914|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.852|STANDARD_ERROR_OF_MEAN|1.5675|||TWO_SIDED|95.0|-2.446|4.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||4.150|-2.446|
91515915|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.357|STANDARD_ERROR_OF_MEAN|1.2918|||TWO_SIDED|95.0|-3.074|2.359|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||2.359|-3.074|
91515916|NCT00833989|182904970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.686|STANDARD_ERROR_OF_MEAN|1.7306|||TWO_SIDED|95.0|-1.937|5.308|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||5.308|-1.937|
91515917|NCT05932290|182905125|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Regression, Cox||Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.|||0.71|0.37|<.0001
91515918|NCT05932290|182905126|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.0003|TWO_SIDED|95.0|0.22|0.64|||Regression, Cox||IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.|||0.64|0.22|.0003
91515919|NCT05932290|182905129|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0062|TWO_SIDED|95.0|0.47|0.88|||Regression, Cox||HRs were estimated using unadjusted Cox proportional hazard models.|||0.88|0.47|.0062
91515920|NCT05932290|182905130|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.0032|TWO_SIDED|95.0|0.27|0.77|||Regression, Cox|IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.||||0.77|0.27|.0032
91515921|NCT00932893|182905133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487|||<|0.0001||95.0|0.371|0.638||To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.||0.638|0.371|<0.0001
91515922|NCT00932893|182905134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.1145||95.0|0.661|1.104||Statistical significance: 1-sided at alpha=0.025|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.||1.104|0.661|0.1145
91515923|NCT00932893|182905136|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.394|||<|0.0001||95.0|2.463|4.676||Statistical significance: 2-sided at alpha=0.025.|Cochran-Mantel-Haenszel|||P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||4.676|2.463|<0.0001
91515924|NCT00932893|182905137|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.502|||<|0.0001||95.0|1.297|1.741||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||1.741|1.297|<0.0001
91515925|NCT00932893|182905138|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.697|||<|0.0001|TWO_SIDED|95.0|1.368|2.103||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||2.103|1.368|<0.0001
91515926|NCT00932893|182905144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.497|||<|0.0001||95.0|0.373|0.661|||Log Rank|||The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.||0.661|0.373|<0.0001
91515927|NCT03750552|182905185|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.574|TWO_SIDED|95.0|-1.05|0.58|||Mixed Model Repeated Measures|||||0.58|-1.05|0.574
91515928|NCT03750552|182905186|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.284||0.331|TWO_SIDED|95.0|-0.84|0.28|||Mixed Model Repeated Measures|||||0.28|-0.84|0.331
91515929|NCT03750552|182905187|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.376||0.481|TWO_SIDED|95.0|-1.01|0.48|||Mixed Model Repeated Measures|||||0.48|-1.01|0.481
91515930|NCT03750552|182905188|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.073||0.74|TWO_SIDED|95.0|-0.12|0.17|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.17|-0.12|0.740
91515931|NCT03750552|182905189|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.064||0.0903|TWO_SIDED|95.0|-0.02|0.24|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.24|-0.02|0.0903
91515932|NCT00581230|182905202|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Wilcoxon signed rank test|||||||0.0003
91515933|NCT00581230|182905203|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
91515934|NCT02008890|182905217|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5722|TWO_SIDED|95.0|0.5|3.53|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.53|0.50|0.5722
91515935|NCT02008890|182905217|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0411|TWO_SIDED|95.0|1.04|6.6|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||6.60|1.04|0.0411
91515936|NCT02008890|182905218|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.9431|TWO_SIDED|95.0|-4.59|3.47|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.47|-4.59|0.9431
91515937|NCT02008890|182905218|SUPERIORITY||Mean Difference (Final Values)|-3.13||||0.1576|TWO_SIDED|95.0|-7.14|0.88|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||0.88|-7.14|0.1576
91515938|NCT02207816|182905225|SUPERIORITY||Vaccine efficacy|74.38||||0.2235|TWO_SIDED|95.0|-130.0|97.14|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||97.14|-130|0.2235
91515939|NCT02207816|182905225|SUPERIORITY||Vaccine efficacy|-9.57||||0.8972|TWO_SIDED|95.0|-339.0|72.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||72.64|-339|0.8972
91515940|NCT02207816|182905225|SUPERIORITY||Vaccine efficacy|30.58||||0.5333|TWO_SIDED|95.0|-119.0|78.0|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||78.00|-119|0.5333
91515941|NCT02207816|182905225|SUPERIORITY||Vaccine efficacy|44.2||||0.3523|TWO_SIDED|95.0|-90.9|83.69|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||83.69|-90.9|0.3523
91515942|NCT02207816|182905226|SUPERIORITY||Vaccine efficacy|53.68||||0.093|TWO_SIDED|95.0|-13.7|81.13|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||81.13|-13.7|0.0930
91515943|NCT02207816|182905226|SUPERIORITY||Vaccine efficacy|23.33||||0.5035|TWO_SIDED|95.0|-67.1|64.82|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||64.82|-67.1|0.5035
91515944|NCT02207816|182905226|SUPERIORITY||Vaccine efficacy|32.08||||0.3504|TWO_SIDED|95.0|-53.1|69.87|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||69.87|-53.1|0.3504
91515945|NCT02207816|182905226|SUPERIORITY||Vaccine efficacy|37.57||||0.2704|TWO_SIDED|95.0|-44.4|73.01|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||73.01|-44.4|0.2704
91515946|NCT02207816|182905227|SUPERIORITY||Vaccine efficacy|-5.26||||0.4434|TWO_SIDED|95.0|-20.0|7.69|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||7.69|-20.0|0.4434
91515947|NCT02207816|182905227|SUPERIORITY||Vaccine efficacy|-8.1||||0.2634|TWO_SIDED|95.0|-23.9|5.7|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||5.70|-23.9|0.2634
91515948|NCT02207816|182905227|SUPERIORITY||Vaccine efficacy|0.62||||0.9278|TWO_SIDED|95.0|-13.7|13.13|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||13.13|-13.7|0.9278
91515949|NCT02207816|182905227|SUPERIORITY||Vaccine efficacy|5.32||||0.4189|TWO_SIDED|95.0|-8.12|17.09|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||17.09|-8.12|0.4189
91515950|NCT02207816|182905228|SUPERIORITY||Vaccine efficacy|50.1||||0.1302|TWO_SIDED|95.0|-32.2|82.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||82.90|-32.2|0.1302
91515951|NCT02207816|182905228|SUPERIORITY||Vaccine efficacy|16.9||||0.6897|TWO_SIDED|95.0|-96.9|65.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||65.90|-96.9|0.6897
91515952|NCT02207816|182905228|SUPERIORITY||Vaccine efficacy|25.9||||0.5299|TWO_SIDED|95.0|-82.9|70.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.90|-82.9|0.5299
91515953|NCT02207816|182905228|SUPERIORITY||Vaccine efficacy|25.4||||0.5307|TWO_SIDED|95.0|-84.1|70.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.70|-84.1|0.5307
91515954|NCT02207816|182905229|SUPERIORITY||Vaccine efficacy|46.2||||0.1853|TWO_SIDED|95.0|-45.0|81.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||81.80|-45.0|0.1853
91515955|NCT02207816|182905229|SUPERIORITY||Vaccine efficacy|35.0||||0.3828|TWO_SIDED|95.0|-69.3|76.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.60|-69.3|0.3828
91515956|NCT02207816|182905229|SUPERIORITY||Vaccine efficacy|31.2||||0.4112|TWO_SIDED|95.0|-66.5|72.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.70|-66.5|0.4112
91515957|NCT02207816|182905229|SUPERIORITY||Vaccine efficacy|30.8||||0.4121|TWO_SIDED|95.0|-67.6|72.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.50|-67.6|0.4121
91515958|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|40.8|||<|0.0001|TWO_SIDED|95.0|15.7|58.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||58.80|15.70|<0.0001
91515959|NCT02207816|182905230|SUPERIORITY||Vaccine effiicacy|42.7|||<|0.0001|TWO_SIDED|95.0|17.4|60.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||60.80|17.40|<0.0001
91515960|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|16.0||||0.0883|TWO_SIDED|95.0|-6.6|33.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||33.90|-6.60|0.0883
91515961|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|13.0||||0.1889|TWO_SIDED|95.0|-10.7|31.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||31.70|-10.7|0.1889
91515962|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|16.4||||0.077|TWO_SIDED|95.0|-5.9|34.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||34.00|-5.90|0.0770
91515963|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|0.1||||1|TWO_SIDED|95.0|-25.8|20.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||20.70|-25.8|1.0000
91515964|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|20.8||||0.1624|TWO_SIDED|95.0|-17.5|46.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||46.90|-17.5|0.1624
91515965|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|-2.3||||0.9112|TWO_SIDED|95.0|-47.6|29.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||29.00|-47.6|0.9112
91515966|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|9.2||||0.4023|TWO_SIDED|95.0|-18.0|30.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||30.10|-18.0|0.4023
91515967|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|-4.4||||0.7091|TWO_SIDED|95.0|-34.5|18.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||18.90|-34.5|0.7091
91515968|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|-1.4||||0.9361|TWO_SIDED|95.0|-34.7|23.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||23.60|-34.7|0.9361
91515969|NCT02207816|182905230|SUPERIORITY||Vaccine efficacy|-6.8||||0.628|TWO_SIDED|95.0|-42.0|19.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||19.60|-42.0|0.6280
91515970|NCT02207816|182905231|SUPERIORITY||Vaccine efficacy|100.0||||0.4987|TWO_SIDED|95.0|-3779.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-3779|0.4987
91515971|NCT02207816|182905231|SUPERIORITY||Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-4051.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-4051|1.0000
91515972|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|-254.6||||0.1025|TWO_SIDED|95.0|-3399.0|32.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||32.50|-3399|0.1025
91515973|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|-398.6||||0.0284|TWO_SIDED|95.0|-4642.0|-3.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||-3.20|-4642|0.0284
91515974|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|36.7||||0.3543|TWO_SIDED|95.0|-78.8|79.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||79.20|-78.8|0.3543
91515975|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|3.2||||1|TWO_SIDED|95.0|-151.0|63.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||63.20|-151|1.0000
91515976|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|44.0||||0.3809|TWO_SIDED|95.0|-120.0|88.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||88.00|-120|0.3809
91515977|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|39.1||||0.549|TWO_SIDED|95.0|-140.0|86.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||86.90|-140|0.5490
91515978|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|-46.3||||0.3239|TWO_SIDED|95.0|-249.0|36.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||36.20|-249|0.3239
91515979|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|47.6||||0.2184|TWO_SIDED|95.0|-54.5|84.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||84.10|-54.5|0.2184
91515980|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|-116.8||||0.0724|TWO_SIDED|95.0|-476.0|10.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||10.30|-476|0.0724
91515981|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|-81.0||||0.2055|TWO_SIDED|95.0|-393.0|27.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||27.90|-393|0.2055
91515982|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|-18.4||||0.8138|TWO_SIDED|95.0|-245.0|57.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||57.90|-245|0.8138
91515983|NCT02207816|182905232|SUPERIORITY||Vaccine efficacy|24.4||||0.7887|TWO_SIDED|95.0|-148.0|78.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||78.40|-148|0.7887
91515984|NCT02207816|182905233|SUPERIORITY||Vaccine efficacy|40.5||||0.0077|TWO_SIDED|95.0|12.84|59.39|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||59.39|12.84|0.0077
91515985|NCT02207816|182905233|SUPERIORITY||Vaccine efficacy|-4.52||||0.7922|TWO_SIDED|95.0|-45.3|24.8|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||24.80|-45.3|0.7922
91515986|NCT02207816|182905233|SUPERIORITY||Vaccine efficacy|29.03||||0.0802|TWO_SIDED|95.0|-4.22|51.67|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||51.67|-4.22|0.0802
91515987|NCT02207816|182905233|SUPERIORITY||Vaccine efficacy|33.87||||0.0387|TWO_SIDED|95.0|2.13|55.32|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||55.32|2.13|0.0387
91515988|NCT02207816|182905234|SUPERIORITY||Vaccine efficacy|36.69||||0.0028|TWO_SIDED|95.0|14.6|53.07|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||53.07|14.60|0.0028
91515989|NCT02207816|182905234|SUPERIORITY||Vaccine efficacy|10.14||||0.443|TWO_SIDED|95.0|-18.1|31.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||31.64|-18.1|0.4430
91515990|NCT02207816|182905234|SUPERIORITY||Vaccine efficacy|30.99||||0.0245|TWO_SIDED|95.0|4.67|50.04|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||50.04|4.67|0.0245
91515991|NCT02207816|182905234|SUPERIORITY||Vaccine efficacy|34.24||||0.0122|TWO_SIDED|95.0|8.74|52.61|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||52.61|8.74|0.0122
91515992|NCT02207816|182905235|SUPERIORITY||Vaccine efficacy|23.67|||<|0.0001|TWO_SIDED|95.0|15.93|30.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||30.71|15.93|<.0001
91515993|NCT02207816|182905235|SUPERIORITY||Vaccine efficacy|19.15|||<|0.0001|TWO_SIDED|95.0|10.81|26.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||26.71|10.81|<.0001
91515994|NCT02207816|182905235|SUPERIORITY||Vaccine efficacy|15.55||||0.0009|TWO_SIDED|95.0|6.72|23.54|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||23.54|6.72|0.0009
91515995|NCT02207816|182905235|SUPERIORITY||Vaccine efficacy|13.15||||0.0056|TWO_SIDED|95.0|4.05|21.39|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||21.39|4.05|0.0056
91515996|NCT02207816|182905236|SUPERIORITY||Vaccine efficacy|35.5||||0.0053|TWO_SIDED|95.0|10.0|54.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.00|10.00|0.0053
91515997|NCT02207816|182905236|SUPERIORITY||Vaccine efficacy|11.7||||0.4255|TWO_SIDED|95.0|-20.0|35.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||35.20|-20.0|0.4255
91515998|NCT02207816|182905236|SUPERIORITY||Vaccine efficacy|29.2||||0.0479|TWO_SIDED|95.0|-2.4|51.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||51.40|-2.40|0.0479
91515999|NCT02207816|182905236|SUPERIORITY||Vaccine efficacy|18.1||||0.2346|TWO_SIDED|95.0|-16.9|42.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||42.80|-16.9|0.2346
91516000|NCT02207816|182905237|SUPERIORITY||Vaccine efficacy|35.9||||0.0051|TWO_SIDED|95.0|10.3|54.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.40|10.30|0.0051
91516001|NCT02207816|182905237|SUPERIORITY||Vaccine efficacy|14.0||||0.334|TWO_SIDED|95.0|-17.3|37.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||37.10|-17.3|0.3340
91516002|NCT02207816|182905237|SUPERIORITY||Vaccine efficacy|28.5||||0.0511|TWO_SIDED|95.0|-2.9|50.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||50.50|-2.90|0.0511
91516003|NCT02207816|182905237|SUPERIORITY||Vaccine efficacy|20.3||||0.1729|TWO_SIDED|95.0|-13.5|44.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||44.20|-13.5|0.1729
91516004|NCT02207816|182905240|SUPERIORITY||Vaccine efficacy|50.1||||0.6244|TWO_SIDED|95.0|-859.0|99.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||99.20|-859|0.6244
91516005|NCT02207816|182905240|SUPERIORITY||Vaccine efficacy|-5.7||||1|TWO_SIDED|95.0|-1358.0|92.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||92.30|-1358|1.0000
91516006|NCT02207816|182905240|SUPERIORITY||Vaccine efficacy|-188.9||||0.6244|TWO_SIDED|95.0|-15000.0|76.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.80|-15000|0.6244
91516007|NCT02207816|182905240|SUPERIORITY||Vaccine efficacy|3.1||||1|TWO_SIDED|95.0|-7509.0|98.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||98.80|-7509|1.0000
91516008|NCT02207816|182905241|SUPERIORITY||Vaccine efficacy|-98.8||||0.6869|TWO_SIDED|95.0|-2098.0|71.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||71.50|-2098|0.6869
91516009|NCT02207816|182905241|SUPERIORITY||Vaccine efficacy|-406.0||||0.0213|TWO_SIDED|95.0|-4650.0|-7.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||-7.80|-4650|0.0213
91516010|NCT02207816|182905242|SUPERIORITY||Vaccine efficacy|-98.8||||1|TWO_SIDED|95.0|-12000.0|89.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||89.60|-12000|1.0000
91516011|NCT02207816|182905242|SUPERIORITY||Vaccine efficacy|-304.8||||0.2154|TWO_SIDED|95.0|-20000.0|59.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||59.90|-20000|0.2154
91516012|NCT02207816|182905243|SUPERIORITY||Vaccine efficacy|-24.3||||1|TWO_SIDED|95.0|-526.0|73.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||73.30|-526|1.0000
91516013|NCT02207816|182905243|SUPERIORITY||Vaccine efficacy|-77.1||||0.3834|TWO_SIDED|95.0|-725.0|55.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||55.00|-725|0.3834
91516014|NCT02207816|182905243|SUPERIORITY||Vaccine efficacy|-297.5||||0.374|TWO_SIDED|95.0|-19000.0|60.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||60.70|-19000|0.3740
91516015|NCT02207816|182905243|SUPERIORITY||Vaccine efficacy|-498.1||||0.124|TWO_SIDED|95.0|-27000.0|27.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||27.40|-27000|0.1240
91516016|NCT02349295|182905267|OTHER||Odds Ratio (OR)|4.74|||<|0.001|TWO_SIDED|95.0|2.65|8.48||model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).|Regression, Logistic|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.||||8.48|2.65|<0.001
91516017|NCT02349295|182905267|OTHER|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|Odds Ratio (OR)|3.79|||<|0.001|TWO_SIDED|95.0|2.12|6.78|||Regression, Logistic|||model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)||6.78|2.12|<0.001
91579715|NCT00858364|183049046|SUPERIORITY|If non-inferiority was declared for OS and PFS, superiority would be declared for the transfusion endpoint if the p-value from a two-sided test of significance using the Cochran-Mantel-Haenszel method was less than 0.05 in favor of the darbepoetin alfa group.|Odds Ratio (OR)|0.704|||<|0.001|TWO_SIDED|95.0|0.573|0.864|||Cochran-Mantel-Haenszel||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).||0.864|0.573|< 0.001
91579716|NCT00858364|183049046|OTHER||Odds Ratio (OR)|0.705|||<|0.001|TWO_SIDED|95.0|0.574|0.866|||Regression, Logistic||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||0.866|0.574|< 0.001
91579717|NCT00858364|183049048|OTHER||Odds Ratio (OR)|1.173||||0.076|TWO_SIDED|95.0|0.983|1.401|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||1.401|0.983|0.076
91579718|NCT00858364|183049048|OTHER||Odds Ratio (OR)|1.173||||0.078|TWO_SIDED|95.0|0.982|1.401|||Cochran-Mantel-Haenszel|Unstratified analysis||||1.401|0.982|0.078
91579719|NCT00858364|183049050|OTHER||Odds Ratio (OR)|0.741||||0.003|TWO_SIDED|95.0|0.61|0.901|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||0.901|0.610|0.003
91579720|NCT00858364|183049050|OTHER||Odds Ratio (OR)|0.758||||0.003|TWO_SIDED|95.0|0.63|0.913|||Cochran-Mantel-Haenszel|Unstratified analysis||||0.913|0.630|0.003
91579721|NCT01655693|183049056|SUPERIORITY||Hazard Ratio (HR)|1.0|||>|0.991|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Initial 24 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||>0.991
91516018|NCT01259713|182905296|NON_INFERIORITY_OR_EQUIVALENCE|For the interim analysis performed when 50% of the subjects had completed the study, an alpha of 0.0003 was spent. Therefore, the significance level for the 2-sided test in the primary analysis at the end of the study was 0.0497 (corresponding to 95.03% confidence interval (CI)).|Relative risk reduction|0.33||||0.24|TWO_SIDED|95.03|-0.32|0.66||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|A two-group Cochran-Mantel-Haenszel (CMH) test with a 0.05 two-sided significance level and 2:1 allocation of 354 randomized subjects (236 AmBisome, 118 placebo) would have 81% power to detect a relative reduction of 75% if the rate of IFI is 10% in the placebo group (based on unpublished data from the German Multicenter Acute Lymphoblastic Leukemia Working Group (GMALL) and consistent with the published rate of 16.4% in patients with hematological malignancies undergoing remission induction).||0.66|-0.32|0.24
91516019|NCT01259713|182905297|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.15|TWO_SIDED|95.0|-0.11|0.5||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.50|-0.11|0.15
91516020|NCT01259713|182905298|SUPERIORITY_OR_OTHER||Relative risk reduction|-0.01||||0.97|TWO_SIDED|95.0|-0.94|0.47||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.47|-0.94|0.97
91516021|NCT01259713|182905299|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||The p-value is from the log-rank test stratified by region.|Log Rank|||||||0.33
91516022|NCT01259713|182905300|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.22|TWO_SIDED|95.0|-0.19|0.53||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.53|-0.19|0.22
91516023|NCT01259713|182905301|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
91516024|NCT01259713|182905302|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
91516025|NCT01259713|182905303|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED|||||The p-value was from the log-rank test stratified by region.|Log Rank|Participants without consolidation/salvage therapy dates were censored using the earlier of the Early Termination and Study Completion dates.||||||0.69
91516026|NCT01259713|182905304|SUPERIORITY_OR_OTHER||Relative risk reduction|0.08||||0.2|TWO_SIDED|95.0|-0.04|0.19||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|Participants were not stratified for leukemia risk.||0.19|-0.04|0.20
91516027|NCT06111742|182905326|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Induction||||<0.001
91516028|NCT06111742|182905326|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||OR entry||||<0.001
91516029|NCT06111742|182905327|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||0.022
91516030|NCT06111742|182905329|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
91516031|NCT01227681|182905336|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Null hypothesis: there is significant deterioration of UPDRS part III scores from baseline to post G-CSF injection one year||||0.64
91516032|NCT03508843|182905359|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
91516033|NCT03508843|182905360|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
91516034|NCT03508843|182905361|SUPERIORITY||||||>|0.05|||||||McNemar|||||||>.05
91516035|NCT00765843|182905363|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||baseline comparisons||||0.78
91516036|NCT00765843|182905363|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||one month comparisons||||0.21
91516037|NCT00765843|182905363|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||three months comparisons||||0.93
91516038|NCT03555396|182905364|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.483|TWO_SIDED|95.0|-13.53|6.46|||t-test, 2 sided|||||6.46|-13.53|0.483
91516039|NCT03555396|182905365|SUPERIORITY|||||||0.637|||||||Chi-squared|||||||0.637
91516040|NCT03555396|182905366|SUPERIORITY||Mean Difference (Net)|9.54||||0.037|TWO_SIDED|95.0|0.59|18.49||Difference in mean change in adherence from baseline to 6 month follow-up between individuals in the intervention and control arms.|Mixed Models Analysis|Multilevel linear mixed model with random effects (dyad \& intercept); adjusting for participant age, sex, baseline adherence, and partner HIV status||||18.49|0.59|0.037
91516041|NCT03555396|182905367|SUPERIORITY|||||||0.621|||||||Chi-squared|Fisher's Exact Test used for small sample sizes||||||0.621
91516042|NCT03814889|182905394|OTHER|||||||0.00025|||||||Wilcoxon Signed-Rank|Paired, ordinal data||||||0.00025
91516043|NCT03814889|182905395|OTHER|||||||0.0014|||||||Wilcoxon Signed-Rank|||||||0.0014
91516044|NCT03814889|182905396|OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
91516045|NCT03814889|182905397|OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
91516046|NCT03814889|182905400|OTHER|||||||0.001|||||||Wilcoxcon Signed-Ranks|||||||0.001
91516047|NCT00958919|182905402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.0004|TWO_SIDED|95.0|2.69|9.38|||t-test, 2 sided|||||9.38|2.69|.0004
91516048|NCT00958919|182905403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.024|TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||||6.85|0.49|.024
91516049|NCT00958919|182905404|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
91516050|NCT00958919|182905405|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91516051|NCT00958919|182905406|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
91516052|NCT04256733|182905474|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||.23
91516053|NCT04256733|182905475|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||.57
91516054|NCT04256733|182905476|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
91516055|NCT04542343|182905487|OTHER||Mean Difference (Net)|3.0|||<|0.01|TWO_SIDED|95.0|2.246|3.754|||t-test, 2 sided|||||3.75400|2.24600|<0.01
91516056|NCT04542343|182905488|OTHER||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-4.256785|-2.343215|||t-test, 2 sided|||||-2.343215|-4.256785|<0.001
91516057|NCT04542343|182905493|OTHER||Mean Difference (Net)|-0.21818|||<|0.01|TWO_SIDED|95.0|-0.36828|-0.06809|||t-test, 2 sided|||||-0.06809|-0.36828|<0.01
91516058|NCT04542343|182905494|OTHER||Mean Difference (Net)|0.05623|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|0.00459|0.10788|||t-test, 2 sided|||||0.10788|0.00459|<0.05
91516059|NCT00321854|182905497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.6503||95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6503
91516060|NCT00321854|182905498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.9568||95.0|-1.7|1.8|||ANCOVA|||||1.8|-1.7|0.9568
91516061|NCT00321854|182905499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.3|-3.2|||ANCOVA|||||-3.2|-6.3|<0.0001
91516062|NCT00321854|182905500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.8|-3.0|||ANCOVA|||||-3|-5.8|<0.0001
91516063|NCT00321854|182905501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.1|-1.7|||ANCOVA|||||-1.7|-4.1|<0.0001
91516064|NCT00321854|182905502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9||0.8693||95.0|-1.8|1.5|||ANCOVA|||||1.5|-1.8|0.8693
91516065|NCT00321854|182905503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.9||0.8155||95.0|-1.5|1.9|||ANCOVA|||||1.9|-1.5|0.8155
91516066|NCT00321854|182905504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.0|-3.0|||ANCOVA|||||-3|-6|<0.0001
91516067|NCT00321854|182905505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.4|-2.6|||ANCOVA|||||-2.6|-5.4|<0.0001
91516068|NCT00321854|182905506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.9|-1.7|||ANCOVA|||||-1.7|-3.9|<0.0001
91516069|NCT00321854|182905507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7999||95.0|-1.5|1.1|||ANCOVA|||||1.1|-1.5|0.7999
91516070|NCT00321854|182905508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7395||95.0|-1.1|1.5|||ANCOVA|||||1.5|-1.1|0.7395
91516071|NCT00321854|182905509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.5|-2.2|||ANCOVA|||||-2.2|-4.5|<0.0001
91516072|NCT00321854|182905510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.0|-1.8|||ANCOVA|||||-1.8|-4|<0.0001
91516073|NCT00321854|182905511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.5||0.0002||95.0|-2.7|-0.9|||ANCOVA|||||-0.9|-2.7|0.0002
91516074|NCT00321854|182905512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9256||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9256
91516075|NCT00321854|182905513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9792||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9792
91516076|NCT00321854|182905514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0001||95.0|-1.7|-0.5|||ANCOVA|||||-0.5|-1.7|0.0001
91516077|NCT00321854|182905515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|-1.6|-0.6|||ANCOVA|||||-0.6|-1.6|<0.0001
91516078|NCT00321854|182905516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.5|-0.6|||ANCOVA|||||-0.6|-1.5|<0.0001
91516079|NCT00321854|182905517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0376||95.0|-0.5|0.0|||ANCOVA|||||0|-0.5|0.0376
91516080|NCT00321854|182905518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1607||95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.1607
91516081|NCT00321854|182905519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0173||95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|0.0173
91516082|NCT00321854|182905520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0007||95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0007
91516083|NCT00321854|182905521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4381||95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.4381
91516084|NCT00321854|182905522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.796||||0.5116||95.0|0.403|1.573|||Regression, Logistic|||||1.573|0.403|0.5116
91516085|NCT00321854|182905523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.7913||95.0|0.403|3.299|||Regression, Logistic|||The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression||3.299|0.403|0.7913
91516086|NCT00321854|182905524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1702||95.0|-1.3|0.2|||ANCOVA|||||0.2|-1.3|0.1702
91516087|NCT00321854|182905525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0009||95.0|-2.2|-0.6|||ANCOVA|||||-0.6|-2.2|0.0009
91516088|NCT00321854|182905526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0005||95.0|-2.1|-0.6|||ANCOVA|||||-0.6|-2.1|0.0005
91516089|NCT00321854|182905527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0422||95.0|-1.4|0.0|||ANCOVA|||||0|-1.4|0.0422
91516090|NCT00321854|182905528|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.573||||0.2149||95.0|-1.823|0.677|||Wilcoxon (Mann-Whitney)|||||0.677|-1.823|0.2149
91516091|NCT00321854|182905529|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.031||||0.0001||95.0|-3.125|-0.938|||Wilcoxon (Mann-Whitney)|||||-0.938|-3.125|0.0001
91516092|NCT00321854|182905530|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2605||95.0|0.0|0.026|||Wilcoxon (Mann-Whitney)|||||0.026|0|0.2605
91516093|NCT00321854|182905531|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.051|||<|0.0001||95.0|0.0|0.089|||Wilcoxon (Mann-Whitney)|||||0.089|0|<0.0001
91516094|NCT00321854|182905532|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.0||||0.0489||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0489
91516095|NCT00321854|182905533|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.0||||0.0282||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0282
91516096|NCT00321854|182905549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.8397||95.0|-5.4|4.4|||ANCOVA|||||4.4|-5.4|0.8397
91516097|NCT01369342|182905554|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516098|NCT01369342|182905554|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516099|NCT01369342|182905555|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||0.009
91516100|NCT01369342|182905555|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516101|NCT01369342|182905556|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516102|NCT01369342|182905556|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516103|NCT01369342|182905557|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516104|NCT01369342|182905557|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516105|NCT01369342|182905558|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516106|NCT01369342|182905558|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
91516107|NCT01816594|182905559|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||All participantss||||0.811
91516108|NCT01816594|182905560|SUPERIORITY|||||||0.83|||||||Fisher Exact|(one-sided)||wild type cohort||||0.830
91516109|NCT01816594|182905561|SUPERIORITY|||||||0.786|||||||Fisher Exact|(one-sided)||mutant cohort||||0.786
91516110|NCT01816594|182905562|SUPERIORITY|||||||0.286|||||||Fisher Exact|(one-sided)||All participants||||0.286
91516111|NCT01816594|182905563|SUPERIORITY|||||||0.177|||||||Fisher Exact|(one-sided)||wild type cohort||||0.177
91516112|NCT01816594|182905564|SUPERIORITY|||||||0.929|||||||Fisher Exact|(one-sided)||mutant cohort||||0.929
91516113|NCT01816594|182905565|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||||||0.811
91516114|NCT01816594|182905566|SUPERIORITY|||||||0.84|||||||Fisher Exact|(one-sided)||||||0.840
91516115|NCT01816594|182905567|SUPERIORITY|||||||0.724|||||||Fisher Exact|(one-sided)||||||0.724
91516116|NCT01816594|182905568|SUPERIORITY|||||||0.964|||||||Fisher Exact|(one-sided)||All participants||||0.964
91516117|NCT01816594|182905569|SUPERIORITY|||||||0.546|||||||Fisher Exact|(one-sided)||For ER+ participants - pCR||||0.546
91516118|NCT01816594|182905570|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - pCR||||0.949
91516119|NCT01816594|182905571|SUPERIORITY|||||||0.053|||||||Fisher Exact|(one-sided)||For ER+ participants - ORR||||0.053
91516120|NCT01816594|182905572|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - ORR||||0.949
91516121|NCT01816594|182905573|SUPERIORITY|||||||0.666|||||||Fisher Exact|(one-sided)||||||0.666
91516122|NCT01816594|182905574|SUPERIORITY|||||||0.803|||||||Fisher Exact|(one-sided)||||||0.803
91516123|NCT03905655|182905575|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91516124|NCT03905655|182905575|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91516125|NCT03905655|182905575|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91516126|NCT03905655|182905576|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91516127|NCT03905655|182905576|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91516128|NCT03905655|182905576|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
91516129|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
91516130|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
91516131|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
91516132|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
91516133|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
91516134|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
91516135|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
91516136|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
91516137|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
91516138|NCT03905655|182905577|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.001
91516139|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
91516140|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
91516141|NCT03905655|182905577|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison of Week 2 values||||<0.001
91516142|NCT03905655|182905577|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.002
91516143|NCT03905655|182905577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
91516144|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516145|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516146|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516147|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516148|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516149|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516150|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516151|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516152|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516153|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516154|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516155|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516156|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516157|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516158|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516159|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516160|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516161|NCT03905655|182905578|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516162|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516163|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516164|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516165|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516166|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516167|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516168|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516169|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516170|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516171|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516172|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516173|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516174|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516175|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516176|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516177|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516178|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516179|NCT03905655|182905579|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516180|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516181|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516182|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516183|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516184|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516185|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516186|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516187|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516188|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516189|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516190|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516191|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516192|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
91516193|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
91516194|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
91516195|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
91516196|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
91516197|NCT03905655|182905580|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
91516198|NCT03905655|182905581|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.006
91516199|NCT03905655|182905581|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.003
91516200|NCT03905655|182905581|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.004
91516201|NCT03905655|182905581|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.006
91516202|NCT03905655|182905581|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.002
91516203|NCT03905655|182905581|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.141
91516204|NCT03905655|182905581|SUPERIORITY|||||||0.081|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.081
91516205|NCT03905655|182905581|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.160
91516206|NCT03905655|182905581|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.184
91516207|NCT03905655|182905581|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.046
91516208|NCT03905655|182905581|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.379
91516209|NCT03905655|182905581|SUPERIORITY|||||||0.308|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.308
91516210|NCT03905655|182905581|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.794
91516211|NCT03905655|182905581|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.297
91516212|NCT03905655|182905581|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.007
91516213|NCT03905655|182905582|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
91516214|NCT03905655|182905582|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
91516215|NCT03905655|182905582|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
91516216|NCT04723576|182905583|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|0.189||||0.77|TWO_SIDED|95.0|-1.068|1.446|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||1.446|-1.068|.77
91516217|NCT04723576|182905584|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.238||||0.39|TWO_SIDED|95.0|-0.31|0.785|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.785|-0.310|.39
91516218|NCT04723576|182905585|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|-0.232||||0.24|TWO_SIDED|95.0|-0.618|0.153|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.153|-0.618|.24
91516219|NCT04723576|182905586|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.134||||0.23|TWO_SIDED|95.0|-0.085|0.352|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.352|-0.085|.23
91516220|NCT04723576|182905587|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|-0.051||||0.44|TWO_SIDED|95.0|-0.179|0.078|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.44
91516221|NCT04723576|182905588|OTHER|Standard 2-sided non-equivalence test|Odds Ratio, log|-0.051||||0.85|TWO_SIDED|95.0|-0.179|0.078|||Repeated measure logistic regression|using GEE method|Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.85
91516222|NCT04723576|182905589|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.23||||0.08|TWO_SIDED|95.0|-0.025|0.484|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care|||0.484|-0.025|.08
91516223|NCT03204279|182905615|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|0.076||||0.55|TWO_SIDED|||||CR in the delayed phase vs AUC0-inf|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs AUC0-inf|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.55
91516224|NCT03204279|182905615|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|-0.041||||0.75|TWO_SIDED|||||CR in the delayed phase vs Cmax|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs Cmax|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.75
91516225|NCT04827212|182905617|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.037|TWO_SIDED|||||P\<0.05|Mixed Models Analysis|||||||0.037
91516226|NCT04827212|182905618|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|||||p-value is adjusted for multiple comparisons- P\<0.025; controlled for baseline values as there was a significant difference between groups at baseline|Mixed Models Analysis|||||||0.78
91516227|NCT04827212|182905619|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.56|TWO_SIDED|||||adjusted for multiple comparisons- P\<0.025; controlled for baseline value due to a significant difference between groups at baseline|Mixed Models Analysis|||||||0.56
91516228|NCT04827212|182905620|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.4
91516229|NCT04827212|182905621|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.18|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.18
91516230|NCT04827212|182905622|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.86
91516231|NCT04827212|182905623|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.21|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.21
91516232|NCT04827212|182905624|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.19|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.19
91516233|NCT04827212|182905625|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
91516234|NCT04827212|182905626|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
91516235|NCT04827212|182905627|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.43|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.43
91516236|NCT04827212|182905628|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.53
91516237|NCT04827212|182905629|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.98|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.98
91516238|NCT04827212|182905630|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.96|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.96
91516239|NCT04827212|182905631|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.91|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.91
91516240|NCT04827212|182905632|SUPERIORITY||Mean Difference (Final Values)|13.1||||0.25|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.25
91516241|NCT04827212|182905633|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.46|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.46
91516242|NCT04827212|182905634|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
91516243|NCT04827212|182905635|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
91516244|NCT04827212|182905636|SUPERIORITY||Mean Difference (Final Values)|-11.9||||0.2|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.20
91516245|NCT04827212|182905637|SUPERIORITY||Mean Difference (Final Values)|-14.0||||0.13|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.13
91516246|NCT04827212|182905638|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.94|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.94
91516247|NCT04827212|182905639|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.72|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.72
91516248|NCT04827212|182905640|SUPERIORITY||Mean Difference (Final Values)|12.3||||0.33|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.33
91516249|NCT03317002|182905641|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
91516250|NCT03317002|182905641|SUPERIORITY||Ratio|0.08||||0.001|ONE_SIDED|95.0||0.1|||Mixed Models Analysis|||||0.10||0.001
91516251|NCT03317002|182905642|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
91516252|NCT03317002|182905642|SUPERIORITY||Ratio|0.09||||0.001|ONE_SIDED|95.0||0.12|||Mixed Models Analysis|||||0.12||0.001
91516253|NCT01592435|182905655|SUPERIORITY_OR_OTHER|||||||0.02||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.02
91516254|NCT01592435|182905656|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.00
91516255|NCT02395042|182905694|SUPERIORITY||Least Squares Mean Difference|-1.15||||0.142|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.142
91516256|NCT02395042|182905694|SUPERIORITY||Least Squares Mean Difference|-0.92||||0.319|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.319
91516257|NCT02395042|182905695|SUPERIORITY||Least Squares Mean Difference|-1.46||||0.024|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.024
91516258|NCT02395042|182905695|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.137|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.137
91516259|NCT01827904|182905725|SUPERIORITY|Percent change from Baseline at the 3 Month visit in the Exablate test vs. Sham control arms was tested using the t-test.|||||<|0.001|||||||t-test, 1 sided|alpha = 0.05 for the hypothesis test. H0: M3ExAblate ≤ M3Sham H1: M3ExAblate \> M3Sham||"Note that the Crossover group was a rescue treatment group and not integral to the experimental design statistical analysis."||||<0.001
91516260|NCT01910519|182905740|OTHER|||||||0.0039|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42||||0.0039
91516261|NCT01910519|182905740|OTHER|||||||0.0368|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42||||0.0368
91516262|NCT01910519|182905740|OTHER|||||||0.0465|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42||||0.0465
91516263|NCT01910519|182905740|OTHER|||||||0.0411|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42||||0.0411
91516264|NCT01910519|182905740|OTHER|||||||0.0067|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42||||0.0067
91516265|NCT04266028|182905741|OTHER|No statistical analyses were performed.|no statistical analyses were performed|0.0|||||TWO_SIDED|||||No statistical analyses were performed||||No statistical analyses were performed.|No statistical analyses were performed.|||
91516266|NCT01458574|182905745|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||31.2|15.3|<0.0001
91516267|NCT01458574|182905745|SUPERIORITY_OR_OTHER||Difference in percentage|29.5|||<|0.0001|TWO_SIDED|95.0|21.4|37.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.6|21.4|<0.0001
91516268|NCT01458574|182905746|SUPERIORITY_OR_OTHER||Difference in percentage|24.2|||<|0.0001|TWO_SIDED|95.0|16.0|32.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.5|16.0|<0.0001
91516269|NCT01458574|182905746|SUPERIORITY_OR_OTHER||Difference in percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.2|41.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.0|24.2|<0.0001
91516270|NCT01458574|182905747|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.2|17.4|<0.0001
91516271|NCT01458574|182905747|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
91516272|NCT01458574|182905748|SUPERIORITY_OR_OTHER||Difference in percentage|22.7|||<|0.0001|TWO_SIDED|95.0|14.8|30.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||30.6|14.8|<0.0001
91516273|NCT01458574|182905748|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
91516274|NCT01458574|182905749|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
91516275|NCT01458574|182905749|SUPERIORITY_OR_OTHER||Difference in percentage|20.3|||<|0.0001|TWO_SIDED|95.0|13.5|27.1|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.1|13.5|<0.0001
91516276|NCT01458574|182905750|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001|TWO_SIDED|95.0|18.1|35.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.5|18.1|<0.0001
91516277|NCT01458574|182905750|SUPERIORITY_OR_OTHER||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|20.3|37.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.7|20.3|<0.0001
91516278|NCT01458574|182905751|SUPERIORITY_OR_OTHER||Difference in percentage|21.2|||<|0.0001|TWO_SIDED|95.0|14.1|28.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||28.3|14.1|<0.0001
91516279|NCT01458574|182905751|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|19.0|33.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||33.8|19.0|<0.0001
91516280|NCT01458574|182905752|SUPERIORITY_OR_OTHER||Difference in percentage|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.1|18.1|<0.0001
91516281|NCT01458574|182905752|SUPERIORITY_OR_OTHER||Difference in percentage|44.5|||<|0.0001|TWO_SIDED|95.0|31.8|57.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||57.2|31.8|<0.0001
91516282|NCT01458574|182905752|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|18.7|41.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.4|18.7|<0.0001
91516283|NCT01458574|182905752|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.0001|TWO_SIDED|95.0|31.1|55.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|31.1|<0.0001
91516284|NCT01458574|182905753|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|13.8|35.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.0|13.8|<0.0001
91516285|NCT01458574|182905753|SUPERIORITY_OR_OTHER||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|28.7|52.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||52.3|28.7|<0.0001
91516286|NCT01458574|182905754|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|20.9|39.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||39.7|20.9|<0.0001
91516287|NCT01458574|182905754|SUPERIORITY_OR_OTHER||Difference in percentage|37.2|||<|0.0001|TWO_SIDED|95.0|28.1|46.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||46.4|28.1|<0.0001
91516288|NCT01458574|182905754|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001|TWO_SIDED|95.0|22.4|40.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||40.2|22.4|<0.0001
91516289|NCT01458574|182905754|SUPERIORITY_OR_OTHER||Difference in percentage|41.7|||<|0.0001|TWO_SIDED|95.0|32.9|50.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.5|32.9|<0.0001
91516290|NCT01458574|182905755|SUPERIORITY_OR_OTHER||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|20.9|38.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.7|20.9|<0.0001
91516291|NCT01458574|182905755|SUPERIORITY_OR_OTHER||Difference in percentage|40.2|||<|0.0001|TWO_SIDED|95.0|31.4|49.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||49.0|31.4|<0.0001
91516292|NCT01458574|182905756|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
91516293|NCT01458574|182905756|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
91516294|NCT01458574|182905756|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
91516295|NCT01458574|182905756|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.9|38.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.2|21.9|<0.0001
91516296|NCT01458574|182905757|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
91516297|NCT01458574|182905757|SUPERIORITY_OR_OTHER||Difference in percentage|20.8|||<|0.0001|TWO_SIDED|95.0|14.0|27.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.7|14.0|<0.0001
91516298|NCT01458574|182905758|SUPERIORITY_OR_OTHER||Difference in percentage|10.1||||0.0006|TWO_SIDED|95.0|4.5|15.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|4.5|0.0006
91516299|NCT01458574|182905758|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.0092|TWO_SIDED|95.0|1.5|11.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.7|1.5|0.0092
91516300|NCT01458574|182905758|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
91516301|NCT01458574|182905758|SUPERIORITY_OR_OTHER||Difference in percentage|11.2|||<|0.0001|TWO_SIDED|95.0|5.5|16.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.9|5.5|<0.0001
91516302|NCT01458574|182905759|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
91516303|NCT01458574|182905759|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.035|TWO_SIDED|95.0|0.3|5.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||5.8|0.3|0.0350
91516304|NCT01458574|182905760|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.3|24.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.0|10.3|<0.0001
91516305|NCT01458574|182905760|SUPERIORITY_OR_OTHER||Difference in percentage|15.3|||<|0.0001|TWO_SIDED|95.0|8.5|22.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.0|8.5|<0.0001
91516306|NCT01458574|182905760|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.0001|TWO_SIDED|95.0|8.8|22.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.5|8.8|<0.0001
91516307|NCT01458574|182905760|SUPERIORITY_OR_OTHER||Difference in percentage|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|27.0|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.0|12.7|<0.0001
91516308|NCT01458574|182905761|SUPERIORITY_OR_OTHER||Difference in percentage|11.1|||<|0.0001|TWO_SIDED|95.0|5.9|16.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.4|5.9|<0.0001
91516309|NCT01458574|182905761|SUPERIORITY_OR_OTHER||Difference in percentage|13.2|||<|0.0001|TWO_SIDED|95.0|7.7|18.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.7|7.7|<0.0001
91516310|NCT01458574|182905762|SUPERIORITY_OR_OTHER||Difference in percentage|12.1|||<|0.0001|TWO_SIDED|95.0|6.3|17.9|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||17.9|6.3|<0.0001
91516311|NCT01458574|182905762|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.0021|TWO_SIDED|95.0|2.8|13.5|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||13.5|2.8|0.0021
91516312|NCT01458574|182905762|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
91516313|NCT01458574|182905762|SUPERIORITY_OR_OTHER||Difference in percentage|12.7|||<|0.0001|TWO_SIDED|95.0|6.8|18.6|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.6|6.8|<0.0001
91516314|NCT01458574|182905763|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
91516315|NCT01458574|182905763|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.0064|TWO_SIDED|95.0|1.4|7.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||7.8|1.4|0.0064
91516316|NCT01458574|182905765|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.9|||Linear mixed effect model|||At Week 24||-1.9|-3.2|<0.0001
91516317|NCT01458574|182905765|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.2|||Linear mixed effect model|||At Week 24||-2.2|-3.5|<0.0001
91516318|NCT01458574|182905765|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.7|||Linear mixed effect model|||At Week 52||-1.7|-3.4|<0.0001
91516319|NCT01458574|182905765|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.5|||Linear mixed effect model|||At Week 52||-2.5|-4.1|<0.0001
91516320|NCT01458574|182905766|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001|TWO_SIDED|95.0|25.0|55.3|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|25.0|<0.0001
91516321|NCT01458574|182905766|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
91516322|NCT01458574|182905766|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.0001|TWO_SIDED|95.0|21.6|50.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.3|21.6|<0.0001
91516323|NCT01458574|182905766|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
91516324|NCT01458574|182905767|SUPERIORITY_OR_OTHER||Difference in percentage|31.8|||<|0.0001|TWO_SIDED|95.0|18.8|44.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||44.8|18.8|<0.0001
91516325|NCT01458574|182905767|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
91516326|NCT01458574|182905768|SUPERIORITY_OR_OTHER||Difference in percentage|38.6|||<|0.0001|TWO_SIDED|95.0|23.4|53.8|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||53.8|23.4|<0.0001
91516327|NCT01458574|182905768|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
91516328|NCT01458574|182905768|SUPERIORITY_OR_OTHER||Difference in percentage|34.4|||<|0.0001|TWO_SIDED|95.0|20.1|48.8|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||48.8|20.1|<0.0001
91516329|NCT01458574|182905768|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
91516330|NCT01458574|182905769|SUPERIORITY_OR_OTHER||Difference in percentage|12.9||||0.0074|TWO_SIDED|95.0|2.6|23.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.2|2.6|0.0074
91516331|NCT01458574|182905769|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0103|TWO_SIDED|95.0|2.4|24.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|2.4|0.0103
91516332|NCT01458574|182905769|SUPERIORITY_OR_OTHER||Difference in percentage|16.8||||0.0018|TWO_SIDED|95.0|6.2|27.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.5|6.2|0.0018
91516333|NCT01458574|182905769|SUPERIORITY_OR_OTHER||Difference in percentage|16.7||||0.0029|TWO_SIDED|95.0|5.5|27.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.9|5.5|0.0029
91516334|NCT01458574|182905770|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.0419|TWO_SIDED|95.0|0.1|15.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|0.1|0.0419
91516335|NCT01458574|182905770|SUPERIORITY_OR_OTHER||Difference in percentage|11.1||||0.0121|TWO_SIDED|95.0|2.3|19.9|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||19.9|2.3|0.0121
91516336|NCT03980470|182905805|SUPERIORITY|||||||0.198|||||||ANOVA|||||||0.198
91516337|NCT03980470|182905806|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
91516338|NCT03980470|182905807|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
91516339|NCT03980470|182905808|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91516340|NCT03980470|182905809|OTHER|Bland-Altmann analysis (bias)|Mean Difference (Final Values)|-1.42|||||TWO_SIDED|||||||||||||
91516341|NCT03394924|182905845|SUPERIORITY||Odds Ratio (OR)|5.6||||0.106|TWO_SIDED|95.0|0.6|52.0|||Cochran-Mantel-Haenszel|||||52|0.6|0.106
91516342|NCT03394924|182905845|SUPERIORITY||Odds Ratio (OR)|7.0||||0.063|TWO_SIDED|95.0|0.75|65.22|||Cochran-Mantel-Haenszel|||||65.22|0.75|0.063
91516343|NCT03394924|182905849|SUPERIORITY||Least squares mean difference|0.47||||0.616|TWO_SIDED|95.0|-1.39|2.32|||ANCOVA|||Analysis for total bilirubin.||2.32|-1.39|0.616
91516344|NCT03394924|182905849|SUPERIORITY||Least squares mean difference|0.19||||0.844|TWO_SIDED|95.0|-1.78|2.16|||ANCOVA|||Analysis for total bilirubin.||2.16|-1.78|0.844
91516345|NCT03394924|182905849|SUPERIORITY||Least squares mean difference|-0.67||||0.18|TWO_SIDED|95.0|-1.67|0.32|||ANCOVA|||Analysis for conjugated bilirubin.||0.32|-1.67|0.18
91516346|NCT03394924|182905849|SUPERIORITY||Least squares mean difference|-0.64||||0.239|TWO_SIDED|95.0|-1.71|0.44|||ANCOVA|||Analysis for conjugated bilirubin.||0.44|-1.71|0.239
91516347|NCT03394924|182905849|SUPERIORITY||Least squares mean difference|1.21||||0.116|TWO_SIDED|95.0|-0.31|2.73|||ANCOVA|||Analysis for unconjugated bilirubin.||2.73|-0.31|0.116
91516348|NCT03394924|182905849|SUPERIORITY||Least squares mean difference|0.72||||0.36|TWO_SIDED|95.0|-0.84|2.28|||ANCOVA|||Analysis for unconjugated bilirubin.||2.28|-0.84|0.36
91516349|NCT03394924|182905850|SUPERIORITY||Least squares mean difference|-25.55||||0.001|TWO_SIDED|95.0|-40.07|-11.04|||ANCOVA|||Analysis for ALT.||-11.04|-40.07|0.001
91516350|NCT03394924|182905850|SUPERIORITY||Least squares mean difference|-21.35||||0.009|TWO_SIDED|95.0|-37.1|-5.6|||ANCOVA|||Analysis for ALT.||-5.6|-37.1|0.009
91516351|NCT03394924|182905850|SUPERIORITY||Least squares mean difference|-21.42||||0|TWO_SIDED|95.0|-32.48|-10.35|||ANCOVA|||Analysis for AST.||-10.35|-32.48|0.000
91516352|NCT03394924|182905850|SUPERIORITY||Least squares mean difference|-20.84||||0.001|TWO_SIDED|95.0|-32.8|-8.87|||ANCOVA|||Analysis for AST.||-8.87|-32.8|0.001
91516353|NCT03394924|182905850|SUPERIORITY||Least squares mean difference|-86.49||||0|TWO_SIDED|95.0|-123.78|-49.21|||ANCOVA|||Analysis for GGT.||-49.21|-123.78|0.000
91516354|NCT03394924|182905850|SUPERIORITY||Least squares mean difference|-115.13||||0|TWO_SIDED|95.0|-155.04|-75.22|||ANCOVA|||Analysis for GGT.||-75.22|-155.04|0.000
91516355|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-26.66||||0.148|TWO_SIDED|95.0|-63.1|9.79|||ANCOVA|||Analysis for HA.||9.79|-63.1|0.148
91516356|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-28.99||||0.142|TWO_SIDED|95.0|-68.02|10.05|||ANCOVA|||Analysis for HA.||10.05|-68.02|0.142
91516357|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-3.09||||0.02|TWO_SIDED|95.0|-5.68|-0.51|||ANCOVA|||Analysis for PIIINP.||-0.51|-5.68|0.02
91516358|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-3.79||||0.009|TWO_SIDED|95.0|-6.6|-0.97|||ANCOVA|||Analysis for PIIINP.||-0.97|-6.6|0.009
91516359|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-41.96||||0.015|TWO_SIDED|95.0|-75.47|-8.44|||ANCOVA|||Analysis for TIMP 1.||-8.44|-75.47|0.015
91516360|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-46.56||||0.011|TWO_SIDED|95.0|-81.91|-11.21|||ANCOVA|||Analysis for TIMP 1.||-11.21|-81.91|0.011
91516361|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-9.73||||0.018|TWO_SIDED|95.0|-17.7|-1.75|||ANCOVA|||Analysis for PRO C3.||-1.75|-17.7|0.018
91516362|NCT03394924|182905851|SUPERIORITY||Least squares mean difference|-6.73||||0.125|TWO_SIDED|95.0|-15.41|1.95|||ANCOVA|||Analysis for PRO C3.||1.95|-15.41|0.125
91516363|NCT03394924|182905852|SUPERIORITY||Least squares mean difference|-0.37||||0|TWO_SIDED|95.0|-0.56|-0.18|||ANCOVA|||||-0.18|-0.56|0.000
91516364|NCT03394924|182905852|SUPERIORITY||Least squares mean difference|-0.33||||0.002|TWO_SIDED|95.0|-0.54|-0.13|||ANCOVA|||||-0.13|-0.54|0.002
91516365|NCT03394924|182905853|SUPERIORITY||Least squares mean difference|-0.35||||0.026|TWO_SIDED|95.0|-0.65|-0.04|||ANCOVA|||||-0.04|-0.65|0.026
91516366|NCT03394924|182905853|SUPERIORITY||Least squares mean difference|-0.26||||0.104|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||||0.05|-0.57|0.104
91516367|NCT03394924|182905854|SUPERIORITY||Least squares mean difference|6.81||||0.757|TWO_SIDED|95.0|-37.17|50.78|||ANCOVA|||Analysis for fibrinogen.||50.78|-37.17|0.757
91516368|NCT03394924|182905854|SUPERIORITY||Least squares mean difference|31.77||||0.174|TWO_SIDED|95.0|-14.42|77.97|||ANCOVA|||Analysis for fibrinogen.||77.97|-14.42|0.174
91516369|NCT03394924|182905854|SUPERIORITY||Least squares mean difference|-0.98||||0.378|TWO_SIDED|95.0|-3.18|1.23|||ANCOVA|||Analysis for CRP.||1.23|-3.18|0.378
91516370|NCT03394924|182905854|SUPERIORITY||Least squares mean difference|-3.1||||0.008|TWO_SIDED|95.0|-5.38|-0.83|||ANCOVA|||Analysis for CRP.||-0.83|-5.38|0.008
91516371|NCT03394924|182905855|SUPERIORITY||Least squares mean difference|0.34||||0.841|TWO_SIDED|95.0|-3.07|3.76|||ANCOVA|||Analysis for IL6.||3.76|-3.07|0.841
91516372|NCT03394924|182905855|SUPERIORITY||Least squares mean difference|-2.49||||0.163|TWO_SIDED|95.0|-6.01|1.04|||ANCOVA|||Analysis for IL6.||1.04|-6.01|0.163
91516373|NCT03394924|182905855|SUPERIORITY||Least squares mean difference|-0.53||||0.03|TWO_SIDED|95.0|-1.02|-0.05|||ANCOVA|||Analysis for TNF α.||-0.05|-1.02|0.03
91516374|NCT03394924|182905855|SUPERIORITY||Least squares mean difference|-0.4||||0.11|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Analysis for TNF α.||0.09|-0.9|0.11
91516375|NCT03394924|182905856|SUPERIORITY||Least squares mean difference|0.01||||0.944|TWO_SIDED|95.0|-0.25|0.27|||ANCOVA|||Analysis for haptoglobin.||0.27|-0.25|0.944
91516376|NCT03394924|182905856|SUPERIORITY||Least squares mean difference|-0.03||||0.83|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Analysis for haptoglobin.||0.24|-0.3|0.83
91516377|NCT03394924|182905856|SUPERIORITY||Least squares mean difference|-0.04||||0.546|TWO_SIDED|95.0|-0.19|0.1|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.1|-0.19|0.546
91516378|NCT03394924|182905856|SUPERIORITY||Least squares mean difference|-0.02||||0.785|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.13|-0.18|0.785
91516379|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.17||||0.176|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Analysis for TG.||0.08|-0.43|0.176
91516380|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.04||||0.783|TWO_SIDED|95.0|-0.3|0.23|||ANCOVA|||Analysis for TG.||0.23|-0.3|0.783
91516381|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.64||||0.061|TWO_SIDED|95.0|-1.31|0.03|||ANCOVA|||Analysis for TC.||0.03|-1.31|0.061
91516382|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.63||||0.08|TWO_SIDED|95.0|-1.34|0.08|||ANCOVA|||Analysis for TC.||0.08|-1.34|0.08
91516383|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|0.08||||0.584|TWO_SIDED|95.0|-0.21|0.37|||ANCOVA|||Analysis for HDL-C.||0.37|-0.21|0.584
91516384|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.22||||0.148|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Analysis for HDL-C.||0.08|-0.51|0.148
91516385|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.5||||0.074|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Analysis for LDL-C.||0.05|-1.04|0.074
91516386|NCT03394924|182905857|SUPERIORITY||Least squares mean difference|-0.3||||0.304|TWO_SIDED|95.0|-0.87|0.28|||ANCOVA|||Analysis for LDL-C.||0.28|-0.87|0.304
91516387|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|0.25||||0.378|TWO_SIDED|95.0|-0.32|0.82|||ANCOVA|||Analysis for duration.||0.82|-0.32|0.378
91516388|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|0.65||||0.03|TWO_SIDED|95.0|0.07|1.23|||ANCOVA|||Analysis for duration.||1.23|0.07|0.03
91516389|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|0.53||||0.036|TWO_SIDED|95.0|0.04|1.03|||ANCOVA|||Analysis for degree.||1.03|0.04|0.036
91516390|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|1.18||||0|TWO_SIDED|95.0|0.67|1.69|||ANCOVA|||Analysis for degree.||1.69|0.67|0.000
91516391|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|0.02||||0.971|TWO_SIDED|95.0|-0.92|0.96|||ANCOVA|||Analysis for direction.||0.96|-0.92|0.971
91516392|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|1.01||||0.042|TWO_SIDED|95.0|0.04|1.99|||ANCOVA|||Analysis for direction.||1.99|0.04|0.042
91516393|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|0.37||||0.336|TWO_SIDED|95.0|-0.4|1.14|||ANCOVA|||Analysis for disability.||1.14|-0.4|0.336
91516394|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|1.46||||0|TWO_SIDED|95.0|0.67|2.26|||ANCOVA|||Analysis for disability.||2.26|0.67|0.000
91516395|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|0.48||||0.214|TWO_SIDED|95.0|-0.29|1.25|||ANCOVA|||Analysis for distribution.||1.25|-0.29|0.214
91516396|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|1.23||||0.003|TWO_SIDED|95.0|0.44|2.02|||ANCOVA|||Analysis for distribution.||2.02|0.44|0.003
91516397|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|2.21||||0.103|TWO_SIDED|95.0|-0.47|4.9|||ANCOVA|||Analysis for total.||4.9|-0.47|0.103
91516398|NCT03394924|182905858|SUPERIORITY||Least squares mean difference|6.35||||0|TWO_SIDED|95.0|3.57|9.13|||ANCOVA|||Analysis for total.||9.13|3.57|0.000
91516399|NCT03394924|182905859|SUPERIORITY||Least squares mean difference|12.48||||0.16|TWO_SIDED|95.0|-5.09|30.06|||ANCOVA|||||30.06|-5.09|0.16
91516400|NCT03394924|182905859|SUPERIORITY||Least squares mean difference|25.58||||0.006|TWO_SIDED|95.0|7.67|43.48|||ANCOVA|||||43.48|7.67|0.006
91516401|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-0.15||||0.908|TWO_SIDED|95.0|-2.72|2.43|||ANCOVA|||Analysis for symptoms.||2.43|-2.72|0.908
91516402|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-1.41||||0.298|TWO_SIDED|95.0|-4.09|1.27|||ANCOVA|||Analysis for symptoms.||1.27|-4.09|0.298
91516403|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|1.91||||0.042|TWO_SIDED|95.0|0.07|3.76|||ANCOVA|||Analysis for itch.||3.76|0.07|0.042
91516404|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|3.47||||0.001|TWO_SIDED|95.0|1.55|5.38|||ANCOVA|||Analysis for itch.||5.38|1.55|0.001
91516405|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-0.46||||0.839|TWO_SIDED|95.0|-4.96|4.04|||ANCOVA|||Analysis for fatigue.||4.04|-4.96|0.839
91516406|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-0.32||||0.891|TWO_SIDED|95.0|-5.0|4.36|||ANCOVA|||Analysis for fatigue.||4.36|-5.00|0.891
91516407|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|0.26||||0.834|TWO_SIDED|95.0|-2.25|2.77|||ANCOVA|||Analysis for cognition.||2.77|-2.25|0.834
91516408|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|1.3||||0.327|TWO_SIDED|95.0|-1.33|3.92|||ANCOVA|||Analysis for cognition.||3.92|-1.33|0.327
91516409|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-2.12||||0.262|TWO_SIDED|95.0|-5.86|1.62|||ANCOVA|||Analysis for social.||1.62|-5.86|0.262
91516410|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-0.78||||0.69|TWO_SIDED|95.0|-4.68|3.12|||ANCOVA|||Analysis for social.||3.12|-4.68|0.69
91516411|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|-0.62||||0.433|TWO_SIDED|95.0|-2.19|0.95|||ANCOVA|||Analysis for emotional.||0.95|-2.19|0.433
91516412|NCT03394924|182905860|SUPERIORITY||Least squares mean difference|0.37||||0.653|TWO_SIDED|95.0|-1.28|2.03|||ANCOVA|||Analysis for emotional.||2.03|-1.28|0.653
91516413|NCT03394924|182905864|SUPERIORITY||Least squares mean difference|1.34||||0.971|TWO_SIDED|95.0|-71.51|74.18|||ANCOVA|||Analysis for FGF19.||74.18|-71.51|0.971
91516414|NCT03394924|182905864|SUPERIORITY||Least squares mean difference|5.54||||0.882|TWO_SIDED|95.0|-68.86|79.95|||ANCOVA|||Analysis for FGF19.||79.95|-68.86|0.882
91516415|NCT03394924|182905864|SUPERIORITY||Least squares mean difference|-51.66||||0.242|TWO_SIDED|95.0|-139.27|35.96|||ANCOVA|||Analysis for C4.||35.96|-139.27|0.242
91516416|NCT03394924|182905864|SUPERIORITY||Least squares mean difference|-94.3||||0.042|TWO_SIDED|95.0|-184.85|-3.75|||ANCOVA|||Analysis for C4.||-3.75|-184.85|0.042
91516417|NCT03394924|182905864|SUPERIORITY||Least squares mean difference|-24.57||||0.52|TWO_SIDED|95.0|-101.03|51.89|||ANCOVA|||Analysis for BA.||51.89|-101.03|0.52
91516418|NCT03394924|182905864|SUPERIORITY||Least squares mean difference|-17.96||||0.672|TWO_SIDED|95.0|-103.07|67.16|||ANCOVA|||Analysis for BA.||67.16|-103.07|0.672
91516419|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|44.54||||0.611|TWO_SIDED|95.0|-205.97|295.06|||ANCOVA|||Analysis for FGF19 AUC0-8.||295.06|-205.97|0.611
91516420|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-29.98||||0.819|TWO_SIDED|95.0|-411.28|351.31|||ANCOVA|||Analysis for FGF19 AUC0-8.||351.31|-411.28|0.819
91516421|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|24.41||||0.818|TWO_SIDED|95.0|-251.92|300.74|||ANCOVA|||Analysis for FGF19 AUC2-8.||300.74|-251.92|0.818
91516422|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-10.53||||0.948|TWO_SIDED|95.0|-435.33|414.27|||ANCOVA|||Analysis for FGF19 AUC2-8.||414.27|-435.33|0.948
91516423|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-91.7||||0.412|TWO_SIDED|95.0|-475.92|292.51|||ANCOVA|||Analysis for C4 AUC0-8.||292.51|-475.92|0.412
91516424|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-250.18||||0.094|TWO_SIDED|95.0|-605.33|104.98|||ANCOVA|||Analysis for C4 AUC0-8.||104.98|-605.33|0.094
91516425|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-83.7||||0.266|TWO_SIDED|95.0|-279.15|111.75|||ANCOVA|||Analysis for C4 AUC2-8.||111.75|-279.15|0.266
91516426|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-238.19||||0.047|TWO_SIDED|95.0|-470.22|-6.15|||ANCOVA|||Analysis for C4 AUC2-8.||-6.15|-470.22|0.047
91516427|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|28.41||||0.694|TWO_SIDED|95.0|-180.2|237.02|||ANCOVA|||Analysis for BA AUC0-8.||237.02|-180.2|0.694
91516428|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-39.5||||0.615|TWO_SIDED|95.0|-264.32|185.32|||ANCOVA|||Analysis for BA AUC0-8.||185.32|-264.32|0.615
91516429|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|2.93||||0.974|TWO_SIDED|95.0|-229.6|235.46|||ANCOVA|||Analysis for BA AUC2-8.||235.46|-229.6|0.974
91516430|NCT03394924|182905865|SUPERIORITY||Least squares mean difference|-26.05||||0.793|TWO_SIDED|95.0|-283.24|231.15|||ANCOVA|||Analysis for BA AUC2-8.||231.15|-283.24|0.793
91516431|NCT02388724|182905937|NON_INFERIORITY|If the lower bound of the 95% confidence intervals of the difference was more than -10% (non-inferiority margin), non-inferiority for Vonoprazan relative to Lansoprazole was declared.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-3.822|6.087||||||||6.087|-3.822|
91516432|NCT02388724|182905938|SUPERIORITY||Difference in percentages|7.2|||||TWO_SIDED|95.0|-1.054|15.371||||||2 Weeks||15.371|-1.054|
91516433|NCT02388724|182905938|SUPERIORITY||Difference in percentages|1.8|||||TWO_SIDED|95.0|-4.763|8.395||||||4 Weeks||8.395|-4.763|
91516434|NCT02479412|182906090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02691|STANDARD_ERROR_OF_MEAN|0.05697||0.6379|TWO_SIDED|95.0|-0.08626|0.1401|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||0.1401|-0.08626|0.6379
91516435|NCT02479412|182906090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07604|STANDARD_ERROR_OF_MEAN|0.05663||0.1827|TWO_SIDED|95.0|-0.03645|0.1885|||Mixed Models Analysis|||AZD7594 250 µg vs.PBO||0.1885|-0.03645|0.1827
91516436|NCT02479412|182906090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478|STANDARD_ERROR_OF_MEAN|0.05679||0.0108|TWO_SIDED|95.0|0.03494|0.2606|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2606|0.03494|0.0108
91516437|NCT02479412|182906091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.857|STANDARD_ERROR_OF_MEAN|3.214||0.1342|TWO_SIDED|95.0|-11.24|1.528|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||1.528|-11.24|0.1342
91516438|NCT02479412|182906091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.41|STANDARD_ERROR_OF_MEAN|3.19||0.0016|TWO_SIDED|95.0|-16.75|-4.075|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.075|-16.75|0.0016
91516439|NCT02479412|182906091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.75|STANDARD_ERROR_OF_MEAN|3.236|<|0.0001|TWO_SIDED|95.0|-21.18|-8.319|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-8.319|-21.18|<0.0001
91516440|NCT02479412|182906092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.139||0.0084|TWO_SIDED|95.0|-24.06|-3.642|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||-3.642|-24.06|0.0084
91516441|NCT02479412|182906092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.26|STANDARD_ERROR_OF_MEAN|5.088||0.0062|TWO_SIDED|95.0|-24.37|-4.149|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.149|-24.37|0.0062
91516442|NCT02479412|182906092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.137||0.0002|TWO_SIDED|95.0|-30.1|-9.689|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-9.689|-30.10|0.0002
91516443|NCT02479412|182906093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03051|STANDARD_ERROR_OF_MEAN|0.05856||0.6036|TWO_SIDED|95.0|-0.08579|0.1468|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.1468|-0.08579|0.6036
91516444|NCT02479412|182906093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01744|STANDARD_ERROR_OF_MEAN|0.05869||0.767|TWO_SIDED|95.0|-0.09912|0.134|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1340|-0.09912|0.7670
91516445|NCT02479412|182906093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1561|STANDARD_ERROR_OF_MEAN|0.05874||0.0093|TWO_SIDED|95.0|0.03943|0.2728|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2728|0.03943|0.0093
91516446|NCT02479412|182906094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03467|STANDARD_ERROR_OF_MEAN|0.05377||0.5207|TWO_SIDED|95.0|-0.1415|0.07213|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.07213|-0.1415|0.5207
91516447|NCT02479412|182906094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02821|STANDARD_ERROR_OF_MEAN|0.05336||0.5983|TWO_SIDED|95.0|-0.07778|0.1342|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1342|-0.07778|0.5983
91516448|NCT02479412|182906094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06169|STANDARD_ERROR_OF_MEAN|0.05371||0.2538|TWO_SIDED|95.0|-0.04501|0.1684|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1684|-0.04501|0.2538
91516449|NCT02479412|182906095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02262|STANDARD_ERROR_OF_MEAN|0.05743||0.6945|TWO_SIDED|95.0|-0.1367|0.09144|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.09144|-0.1367|0.6945
91516450|NCT02479412|182906095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.000314|STANDARD_ERROR_OF_MEAN|0.05755||0.9957|TWO_SIDED|95.0|-0.1146|0.114|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1140|-0.1146|0.9957
91516451|NCT02479412|182906095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06831|STANDARD_ERROR_OF_MEAN|0.05774||0.2398|TWO_SIDED|95.0|-0.04637|0.183|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1830|-0.04637|0.2398
91516452|NCT02479412|182906096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|5.877||0.0819|TWO_SIDED|95.0|-1.335|22.01|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||22.01|-1.335|0.0819
91516453|NCT02479412|182906096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.253|STANDARD_ERROR_OF_MEAN|5.881||0.3741|TWO_SIDED|95.0|-6.427|16.93|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||16.93|-6.427|0.3741
91516454|NCT02479412|182906096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|5.926||0.0374|TWO_SIDED|95.0|0.7481|24.29|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||24.29|0.7481|0.0374
91516455|NCT02479412|182906097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.73|STANDARD_ERROR_OF_MEAN|5.384||0.0044|TWO_SIDED|95.0|5.039|26.43|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||26.43|5.039|0.0044
91516456|NCT02479412|182906097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|5.419||0.0098|TWO_SIDED|95.0|3.534|25.06|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||25.06|3.534|0.0098
91516457|NCT02479412|182906097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.459||0.0004|TWO_SIDED|95.0|9.068|30.75|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||30.75|9.068|0.0004
91516458|NCT02479412|182906098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3435|STANDARD_ERROR_OF_MEAN|0.189||0.0723|TWO_SIDED|95.0|-0.7189|0.03179|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.03179|-0.7189|0.0723
91516459|NCT02479412|182906098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4852|STANDARD_ERROR_OF_MEAN|0.1903||0.0124|TWO_SIDED|95.0|-0.8631|-0.1073|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||-0.1073|-0.8631|0.0124
91516460|NCT02479412|182906098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8026|STANDARD_ERROR_OF_MEAN|0.1914|<|0.0001|TWO_SIDED|95.0|-1.183|-0.4224|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4224|-1.183|<0.0001
91516461|NCT02479412|182906099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3071|STANDARD_ERROR_OF_MEAN|0.1051||0.0044|TWO_SIDED|95.0|-0.5159|-0.09836|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09836|-0.5159|0.0044
91516462|NCT02479412|182906099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1824|STANDARD_ERROR_OF_MEAN|0.1059||0.0883|TWO_SIDED|95.0|-0.3927|0.02789|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.02789|-0.3927|0.0883
91516463|NCT02479412|182906099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4301|STANDARD_ERROR_OF_MEAN|0.1055|<|0.0001|TWO_SIDED|95.0|-0.6397|-0.2205|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.2205|-0.6397|<0.0001
91516464|NCT02479412|182906100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1651|STANDARD_ERROR_OF_MEAN|0.09139||0.0741|TWO_SIDED|95.0|-0.3466|0.01638|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.01638|-0.3466|0.0741
91516465|NCT02479412|182906100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09079|STANDARD_ERROR_OF_MEAN|0.09204||0.3265|TWO_SIDED|95.0|-0.2736|0.09201|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.09201|-0.2736|0.3265
91516466|NCT02479412|182906100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2532|STANDARD_ERROR_OF_MEAN|0.09176||0.007|TWO_SIDED|95.0|-0.4354|-0.07092|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.07092|-0.4354|0.0070
91516467|NCT02479412|182906101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4185|STANDARD_ERROR_OF_MEAN|0.1626||0.0116|TWO_SIDED|95.0|-0.7414|-0.09563|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09563|-0.7414|0.0116
91516468|NCT02479412|182906101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1794|STANDARD_ERROR_OF_MEAN|0.1628||0.2732|TWO_SIDED|95.0|-0.5027|0.1438|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1438|-0.5027|0.2732
91516469|NCT02479412|182906101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7661|STANDARD_ERROR_OF_MEAN|0.1636|<|0.0001|TWO_SIDED|95.0|-1.091|-0.4411|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4411|-1.091|<0.0001
91516470|NCT02479412|182906102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1067|STANDARD_ERROR_OF_MEAN|0.04982||0.0349|TWO_SIDED|95.0|-0.2057|-0.007755|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.007755|-0.2057|0.0349
91516471|NCT02479412|182906102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08205|STANDARD_ERROR_OF_MEAN|0.05015||0.1052|TWO_SIDED|95.0|-0.1817|0.01756|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.01756|-0.1817|0.1052
91516472|NCT02479412|182906102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2027|STANDARD_ERROR_OF_MEAN|0.05044||0.0001|TWO_SIDED|95.0|-0.3028|-0.1025|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.1025|-0.3028|0.0001
91516473|NCT02479412|182906103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.673|STANDARD_ERROR_OF_MEAN|0.2946||0.0247|TWO_SIDED|95.0|0.08779|1.258|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||1.258|0.08779|0.0247
91516474|NCT02479412|182906103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4281|STANDARD_ERROR_OF_MEAN|0.2965||0.1521|TWO_SIDED|95.0|-0.1607|1.017|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||1.017|-0.1607|0.1521
91516475|NCT02479412|182906103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9415|STANDARD_ERROR_OF_MEAN|0.2987||0.0022|TWO_SIDED|95.0|0.3483|1.535|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||1.535|0.3483|0.0022
91516476|NCT02479412|182906107|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|272.2|||<|0.0001|TWO_SIDED|90.0|237.43|312.05|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||312.05|237.43|<0.0001
91516477|NCT02479412|182906107|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|676.13|||<|0.0001|TWO_SIDED|90.0|580.91|786.95|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||786.95|580.91|<0.0001
91516478|NCT02479412|182906108|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|337.82|||<|0.0001|TWO_SIDED|90.0|290.8|392.43|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||392.43|290.80|<0.0001
91516479|NCT02479412|182906108|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|964.62|||<|0.0001|TWO_SIDED|90.0|816.13|1140.13|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||1140.13|816.13|<0.0001
91516480|NCT01571362|182906129|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.246||0.0114|TWO_SIDED|95.0|-1.11|-0.14||No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (\<=) 0.05.|ANCOVA|||Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.||-0.14|-1.11|0.0114
91516481|NCT01571362|182906130|SUPERIORITY_OR_OTHER||Difference of LS Means|0.18|STANDARD_ERROR_OF_MEAN|0.565||0.7547|TWO_SIDED|95.0|-0.94|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.|ANCOVA|||||1.29|-0.94|0.7547
91516482|NCT01571362|182906131|SUPERIORITY_OR_OTHER|||||||0.1272|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)||||||0.1272
91516483|NCT01571362|182906132|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|CMH was stratified by prior pain analgesic (opioid and non-opioid).||||||0.0210
91516484|NCT01571362|182906133|SUPERIORITY_OR_OTHER|||||||0.0248|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0248
91516485|NCT01571362|182906134|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0090
91516486|NCT01571362|182906135|SUPERIORITY_OR_OTHER|||||||0.0874|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0874
91516487|NCT01571362|182906136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Worst Pain Score||||<0.0001
91516488|NCT01571362|182906136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Least Pain Score||||<0.0001
91516489|NCT01571362|182906136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Average Pain Score||||<0.0001
91516490|NCT01571362|182906136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Right Now||||<0.0001
91516491|NCT01571362|182906136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Severity Index||||<0.0001
91516492|NCT01571362|182906136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Interference Index||||<0.0001
91516493|NCT01571362|182906137|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Worst Pain Score||||<0.0001
91516494|NCT01571362|182906137|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Least Pain Score||||<0.0001
91516495|NCT01571362|182906137|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Average Pain Score||||<0.0001
91516496|NCT01571362|182906137|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Right Now||||<0.0001
91516497|NCT01571362|182906137|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Severity Index||||<0.0001
91516498|NCT01571362|182906137|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Interference Index||||<0.0001
91516499|NCT01571362|182906138|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.222||0.0056|TWO_SIDED|95.0|-1.06|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.18|-1.06|0.0056
91516500|NCT01571362|182906138|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.243||0.009|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.16|-1.12|0.0090
91516501|NCT01571362|182906138|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.271||0.1684|TWO_SIDED|95.0|-0.91|0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.16|-0.91|0.1684
91516502|NCT01571362|182906138|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.50|-1.46|<0.0001
91516503|NCT01571362|182906139|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.193||0.0412|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2||-0.02|-0.78|0.0412
91516504|NCT01571362|182906139|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.87|STANDARD_ERROR_OF_MEAN|0.201|<|0.0001|TWO_SIDED|95.0|-1.27|-0.48|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4||-0.48|-1.27|<0.0001
91516505|NCT01571362|182906139|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.226||0.0055|TWO_SIDED|95.0|-1.08|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.08|0.0055
91516506|NCT01571362|182906139|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.27|<0.0001
91516507|NCT01571362|182906140|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.19||0.0007|TWO_SIDED|95.0|-1.02|-0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.27|-1.02|0.0007
91516508|NCT01571362|182906140|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.74|STANDARD_ERROR_OF_MEAN|0.213||0.0006|TWO_SIDED|95.0|-1.16|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.32|-1.16|0.0006
91516509|NCT01571362|182906140|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.18|-1.11|0.0070
91516510|NCT01571362|182906140|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-1.31|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.31|<0.0001
91516511|NCT01571362|182906141|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.207||0.0022|TWO_SIDED|95.0|-1.05|-0.23|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.23|-1.05|0.0022
91516512|NCT01571362|182906141|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.214||0.0003|TWO_SIDED|95.0|-1.21|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.21|0.0003
91516513|NCT01571362|182906141|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.264||0.0078|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.23|0.0078
91516514|NCT01571362|182906141|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.231|<|0.0001|TWO_SIDED|95.0|-1.52|-0.62|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.62|-1.52|<0.0001
91516515|NCT01571362|182906142|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.189||0.0022|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.21|-0.95|0.0022
91516516|NCT01571362|182906142|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.198||0.0002|TWO_SIDED|95.0|-1.15|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.15|0.0002
91516517|NCT01571362|182906142|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.61|STANDARD_ERROR_OF_MEAN|0.228||0.0078|TWO_SIDED|95.0|-1.06|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.16|-1.06|0.0078
91516518|NCT01571362|182906142|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.54|-1.35|<0.0001
91516519|NCT01571362|182906143|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.188||0.0285|TWO_SIDED|95.0|-0.78|-0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.04|-0.78|0.0285
91516520|NCT01571362|182906143|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.188||0.0106|TWO_SIDED|95.0|-0.85|-0.11|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.11|-0.85|0.0106
91516521|NCT01571362|182906143|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.222||0.4529|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.27|-0.60|0.4529
91516522|NCT01571362|182906143|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.207||0.0018|TWO_SIDED|95.0|-1.06|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.25|-1.06|0.0018
91516523|NCT01571362|182906144|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.258||0.0061|TWO_SIDED|95.0|-1.22|-0.2|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.20|-1.22|0.0061
91516524|NCT01571362|182906144|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.277||0.0087|TWO_SIDED|95.0|-1.28|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.19|-1.28|0.0087
91516525|NCT01571362|182906144|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.315||0.0769|TWO_SIDED|95.0|-1.18|0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.06|-1.18|0.0769
91516526|NCT01571362|182906144|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.1|STANDARD_ERROR_OF_MEAN|0.289||0.0002|TWO_SIDED|95.0|-1.67|-0.53|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.53|-1.67|0.0002
91516527|NCT01571362|182906145|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.224||0.025|TWO_SIDED|95.0|-0.95|-0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.06|-0.95|0.0250
91516528|NCT01571362|182906145|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.234||0.0002|TWO_SIDED|95.0|-1.36|-0.43|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.43|-1.36|0.0002
91516529|NCT01571362|182906145|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.263||0.0038|TWO_SIDED|95.0|-1.29|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.29|0.0038
91516530|NCT01571362|182906145|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.50|-1.46|<0.0001
91516531|NCT01571362|182906146|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.214||0.0002|TWO_SIDED|95.0|-1.22|-0.38|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.38|-1.22|0.0002
91516532|NCT01571362|182906146|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.78|STANDARD_ERROR_OF_MEAN|0.235||0.001|TWO_SIDED|95.0|-1.25|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.32|-1.25|0.0010
91516533|NCT01571362|182906146|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.271||0.0041|TWO_SIDED|95.0|-1.32|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.32|0.0041
91516534|NCT01571362|182906146|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
91516535|NCT01571362|182906147|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.236||0.0115|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.14|-1.06|0.0115
91516536|NCT01571362|182906147|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.256||0.0099|TWO_SIDED|95.0|-1.17|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.16|-1.17|0.0099
91516537|NCT01571362|182906147|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.307||0.0222|TWO_SIDED|95.0|-1.31|-0.1|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.10|-1.31|0.0222
91516538|NCT01571362|182906147|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|95.0|-1.54|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.50|-1.54|0.0001
91516539|NCT01571362|182906148|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.218||0.0025|TWO_SIDED|95.0|-1.09|-0.24|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.24|-1.09|0.0025
91516540|NCT01571362|182906148|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.235||0.0012|TWO_SIDED|95.0|-1.23|-0.31|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.31|-1.23|0.0012
91516541|NCT01571362|182906148|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.272||0.0078|TWO_SIDED|95.0|-1.27|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.19|-1.27|0.0078
91516542|NCT01571362|182906148|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
91516543|NCT01571362|182906149|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.228||0.0727|TWO_SIDED|95.0|-0.86|0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||0.04|-0.86|0.0727
91516544|NCT01571362|182906149|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.238||0.0501|TWO_SIDED|95.0|-0.94|0.0|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||0.00|-0.94|0.0501
91516545|NCT01571362|182906149|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.262||0.5704|TWO_SIDED|95.0|-0.67|0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.37|-0.67|0.5704
91516546|NCT01571362|182906149|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.245||0.0096|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.16|-1.12|0.0096
91516547|NCT01571362|182906150|SUPERIORITY_OR_OTHER||Difference of LS Means|-27.75|STANDARD_ERROR_OF_MEAN|10.968||0.012|TWO_SIDED|95.0|-49.34|-6.16|||ANCOVA||Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|||-6.16|-49.34|0.0120
91516548|NCT01571362|182906151|SUPERIORITY_OR_OTHER||Difference of LS Means|-3.87|STANDARD_ERROR_OF_MEAN|50.5||0.939|TWO_SIDED|95.0|-103.29|95.55|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.|||95.55|-103.29|0.9390
91516549|NCT01571362|182906157|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 20% loss of analgesic response||||0.0014
91516550|NCT01571362|182906157|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 30% loss of analgesic response.||||0.0024
91516551|NCT01571362|182906157|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 40% loss of analgesic response.||||0.0006
91516552|NCT01571362|182906157|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 50% loss of analgesic response||||0.0021
91516553|NCT01571362|182906159|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors.||||||0.006
91516554|NCT01571362|182906169|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to the End of Open-Label Titration Period.||||<0.0001
91516555|NCT01571362|182906170|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline.||||<0.0001
91516556|NCT01571362|182906171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.584||0.0733|TWO_SIDED|95.0|-2.2|0.1||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 2.||0.10|-2.20|0.0733
91516557|NCT01571362|182906171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.642||0.2783|TWO_SIDED|95.0|-1.96|0.57||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 4.||0.57|-1.96|0.2783
91516558|NCT01571362|182906171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.684||0.3951|TWO_SIDED|95.0|-0.77|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 8.||1.93|-0.77|0.3951
91516559|NCT01571362|182906171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.614||0.9063|TWO_SIDED|95.0|-1.14|1.28||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 12.||1.28|-1.14|0.9063
91516560|NCT01571362|182906172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.463||0.1139|TWO_SIDED|95.0|-1.65|0.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted change from Baseline to Week 2.||0.18|-1.65|0.1139
91516561|NCT01571362|182906172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.577||0.2264|TWO_SIDED|95.0|-1.84|0.44||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 4.||0.44|-1.84|0.2264
91516562|NCT01571362|182906172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.619||0.5074|TWO_SIDED|95.0|-0.81|1.63||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 8.||1.63|-0.81|0.5074
91516563|NCT01571362|182906173|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
91516564|NCT01571362|182906174|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
91516565|NCT01571362|182906175|SUPERIORITY_OR_OTHER|||||||0.2211|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.2211
91516566|NCT01571362|182906176|SUPERIORITY_OR_OTHER|||||||0.5767|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.5767
91516567|NCT01571362|182906179|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.0004
91516568|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.||||<0.0001
91516569|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.||||<0.0001
91516570|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.||||<0.0001
91516571|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for General Health.||||<0.0001
91516572|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Vitality.||||<0.0001
91516573|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.||||<0.0001
91516574|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.||||<0.0001
91516575|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Health.||||<0.0001
91516576|NCT01571362|182906180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.||||<0.0001
91516577|NCT01571362|182906180|SUPERIORITY_OR_OTHER|||||||0.0026|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.||||0.0026
91516578|NCT01571362|182906181|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score||||<0.0001
91516579|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|0.952||0.5181|TWO_SIDED|95.0|-1.26|2.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Functioning.||2.49|-1.26|0.5181
91516580|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.998||0.9733|TWO_SIDED|95.0|-2.0|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Physical.||1.93|-2.00|0.9733
91516581|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|0.914||0.01|TWO_SIDED|95.0|0.57|4.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Bodily Pain.||4.18|0.57|0.0100
91516582|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.764||0.4712|TWO_SIDED|95.0|-2.06|0.95||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.||0.95|-2.06|0.4712
91516583|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|STANDARD_ERROR_OF_MEAN|1.091||0.2898|TWO_SIDED|95.0|-3.3|0.99||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Vitality.||0.99|-3.30|0.2898
91516584|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|1.044||0.1565|TWO_SIDED|95.0|-0.57|3.54||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Social Functioning.||3.54|-0.57|0.1565
91516585|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.348||0.522|TWO_SIDED|95.0|-3.52|1.79||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Emotional.||1.79|-3.52|0.5220
91516586|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.995||0.9865|TWO_SIDED|95.0|-1.94|1.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Health.||1.98|-1.94|0.9865
91516587|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.885||0.2491|TWO_SIDED|95.0|-0.72|2.77||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Component Score.||2.77|-0.72|0.2491
91516588|NCT01571362|182906182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|1.073||0.5219|TWO_SIDED|95.0|-2.8|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Component Score.||1.43|-2.80|0.5219
91516589|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.111||0.1731|TWO_SIDED|95.0|-0.67|3.71||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Functioning.||3.71|-0.67|0.1731
91516590|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.127||0.329|TWO_SIDED|95.0|-1.12|3.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Physical.||3.32|-1.12|0.3290
91516591|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|1.047||0.0232|TWO_SIDED|95.0|0.33|4.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Bodily Pain.||4.45|0.33|0.0232
91516592|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.858||0.8139|TWO_SIDED|95.0|-1.89|1.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for General Health Perceptions.||1.49|-1.89|0.8139
91516593|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|1.117||0.6878|TWO_SIDED|95.0|-2.65|1.75||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Vitality.||1.75|-2.65|0.6878
91516594|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.08||0.0658|TWO_SIDED|95.0|-0.13|4.12||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Social Functioning.||4.12|-0.13|0.0658
91516595|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|1.374||0.867|TWO_SIDED|95.0|-2.48|2.94||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Emotional.||2.94|-2.48|0.8670
91516596|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|1.056||0.7259|TWO_SIDED|95.0|-1.71|2.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Health.||2.45|-1.71|0.7259
91516597|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.007||0.0989|TWO_SIDED|95.0|-0.32|3.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Component Score.||3.65|-0.32|0.0989
91516598|NCT01571362|182906183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.142||0.9969|TWO_SIDED|95.0|-2.25|2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Component Score.||2.25|-2.25|0.9969
91516599|NCT01571362|182906184|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91516600|NCT01571362|182906185|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91516601|NCT01571362|182906186|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91516602|NCT01571362|182906187|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
91516603|NCT01571362|182906188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.0168||0.0605|TWO_SIDED|95.0|-0.001|0.065||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||0.065|-0.001|0.0605
91516604|NCT01571362|182906189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|1.999||0.7196|TWO_SIDED|95.0|-3.22|4.66||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||4.66|-3.22|0.7196
91516605|NCT01571362|182906190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.0172||0.228|TWO_SIDED|95.0|-0.013|0.055||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||0.055|-0.013|0.2280
91516606|NCT01571362|182906191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|2.048||0.2701|TWO_SIDED|95.0|-1.77|6.3||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||6.30|-1.77|0.2701
91516607|NCT01571362|182906192|SUPERIORITY_OR_OTHER|||||||0.3822|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.||||0.3822
91516608|NCT01571362|182906192|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.||||<0.0001
91516609|NCT01571362|182906192|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.||||<0.0001
91516610|NCT01571362|182906192|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.||||<0.0001
91516611|NCT01571362|182906193|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain||||0.0017
91516612|NCT01571362|182906193|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain||||<0.0001
91516613|NCT01571362|182906193|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain||||<0.0001
91516614|NCT01571362|182906193|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain||||<0.0001
91516615|NCT01571362|182906194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.31|STANDARD_ERROR_OF_MEAN|2.883||0.1389|TWO_SIDED|95.0|-10.06|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.43|-10.06|0.1389
91516616|NCT01571362|182906194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88|STANDARD_ERROR_OF_MEAN|4.34||0.5094|TWO_SIDED|95.0|-11.56|5.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.80|-11.56|0.5094
91516617|NCT01571362|182906194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|4.043||0.4944|TWO_SIDED|95.0|-10.81|5.26||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.26|-10.81|0.4944
91516618|NCT01571362|182906195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|4.295||0.1201|TWO_SIDED|95.0|-15.33|1.81||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.81|-15.33|0.1201
91516619|NCT01571362|182906195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.99|STANDARD_ERROR_OF_MEAN|5.288||0.3497|TWO_SIDED|95.0|-15.6|5.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.62|-15.60|0.3497
91516620|NCT01571362|182906195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_ERROR_OF_MEAN|4.532||0.6008|TWO_SIDED|95.0|-11.41|6.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||6.65|-11.41|0.6008
91516621|NCT01571362|182906196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.34|STANDARD_ERROR_OF_MEAN|4.986||0.1458|TWO_SIDED|95.0|-17.29|2.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||2.62|-17.29|0.1458
91516622|NCT01571362|182906196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.35|STANDARD_ERROR_OF_MEAN|6.496||0.1558|TWO_SIDED|95.0|-22.38|3.68||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||3.68|-22.38|0.1558
91516623|NCT01571362|182906196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.14|STANDARD_ERROR_OF_MEAN|5.582||0.3604|TWO_SIDED|95.0|-16.25|5.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.98|-16.25|0.3604
91516624|NCT01571362|182906197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.389||0.0768|TWO_SIDED|95.0|-8.95|0.46||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||0.46|-8.95|0.0768
91516625|NCT01571362|182906197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.684||0.7109|TWO_SIDED|95.0|-4.3|6.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||6.29|-4.30|0.7109
91516626|NCT01571362|182906197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|2.536||0.1031|TWO_SIDED|95.0|-9.14|0.85||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||0.85|-9.14|0.1031
91516627|NCT01571362|182906198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73|STANDARD_ERROR_OF_MEAN|2.776||0.0926|TWO_SIDED|95.0|-10.26|0.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||0.80|-10.26|0.0926
91516628|NCT01571362|182906198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|3.414||0.6437|TWO_SIDED|95.0|-8.42|5.24||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||5.24|-8.42|0.6437
91516629|NCT01571362|182906198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|3.391||0.748|TWO_SIDED|95.0|-7.84|5.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||5.65|-7.84|0.7480
91516630|NCT01571362|182906199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.38|STANDARD_ERROR_OF_MEAN|4.666||0.0098|TWO_SIDED|95.0|-21.68|-3.07||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-3.07|-21.68|0.0098
91516631|NCT01571362|182906199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|5.336||0.0186|TWO_SIDED|95.0|-23.63|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.25|-23.63|0.0186
91516632|NCT01571362|182906199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|4.785||0.0581|TWO_SIDED|95.0|-18.72|0.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.32|-18.72|0.0581
91516633|NCT01571362|182906200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.56|STANDARD_ERROR_OF_MEAN|5.168||0.0177|TWO_SIDED|95.0|-22.87|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.25|-22.87|0.0177
91516634|NCT01571362|182906200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.16|STANDARD_ERROR_OF_MEAN|5.998||0.0219|TWO_SIDED|95.0|-26.19|-2.14||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.14|-26.19|0.0219
91516635|NCT01571362|182906200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.35|STANDARD_ERROR_OF_MEAN|5.589||0.0679|TWO_SIDED|95.0|-21.47|0.78||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.78|-21.47|0.0679
91516636|NCT01571362|182906201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.654||0.0052|TWO_SIDED|95.0|-12.72|-2.27||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.27|-12.72|0.0052
91516637|NCT01571362|182906201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.62|STANDARD_ERROR_OF_MEAN|2.999||0.1249|TWO_SIDED|95.0|-10.54|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||1.29|-10.54|0.1249
91516638|NCT01571362|182906201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.19|STANDARD_ERROR_OF_MEAN|2.818||0.004|TWO_SIDED|95.0|-13.74|-2.64||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||-2.64|-13.74|0.0040
91516639|NCT04386096|182906237|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
91516640|NCT04386096|182906239|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change in Adolescent Pre-Intention Factors||||0.30
91516641|NCT04386096|182906239|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Change in Parent Pre-Intention Factors||||0.71
91516642|NCT04386096|182906240|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Change in Adolescent Intention to take/give ADHD medicine regularly||||0.29
91516643|NCT04386096|182906240|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||Change in Parent Intention to take/give ADHD medicine regularly||||0.19
91516644|NCT04386096|182906241|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
91516645|NCT04386096|182906242|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
91516646|NCT04386096|182906244|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Adolescent: Child Seek||||0.10
91516647|NCT04386096|182906244|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Change in Adolescent: Child Express||||0.51
91516648|NCT04386096|182906244|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Change in Adolescent: Parent Seek||||0.84
91516649|NCT04386096|182906244|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Change in Adolescent: Parent Express||||0.93
91516650|NCT04386096|182906244|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Change in Adolescent: Joint/Options||||0.43
91516651|NCT04386096|182906244|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Change in Parent: Child Seek||||0.94
91516652|NCT04386096|182906244|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Change in Parent: Child Express||||0.79
91516653|NCT04386096|182906244|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Change in Parent: Parent Seek||||0.61
91516654|NCT04386096|182906244|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Parent: Parent Express||||0.10
91516655|NCT04386096|182906244|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Change in Parent: Joint/Options||||0.98
91516656|NCT04402866|182906307|OTHER||Common Odds Ratio|1.142||||0.6137|TWO_SIDED|95.0|0.706|1.846|||Van Elteren test||Common Odds Ratio (TD-0903 vs. placebo) and corresponding 95% Wald confidence interval (CI) were obtained from the proportional odds regression model of RFD adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.||1.846|0.706|0.6137
91516657|NCT04402866|182906308|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|LS mean difference|-0.51||||0.962|TWO_SIDED|95.0|-21.95|20.92|||Mixed model repeated measures model|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||20.92|-21.95|0.962
91516658|NCT04402866|182906309|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.153||||0.5918|TWO_SIDED|95.0|0.692|1.922|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 7||1.922|0.692|0.5918
91516659|NCT04402866|182906309|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.105||||0.6978|TWO_SIDED|95.0|0.651|1.878|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 14|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|1.878|0.651|0.6978
91516660|NCT04402866|182906309|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.295||||0.399|TWO_SIDED|95.0|0.702|2.388|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 21|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|2.388|0.702|0.3990
91516661|NCT04402866|182906309|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.18||||0.6445|TWO_SIDED|95.0|0.605|2.299|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 28||2.299|0.605|0.6445
91516662|NCT04402866|182906310|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Risk Difference (RD)|5.06||||0.3005|TWO_SIDED|95.0|-4.5|14.63||The p-value was calculated using the Cochran-Mantel-Haenszel chi-square test stratified by baseline age group (≤ 60 years vs. \> 60 years)|Cochran-Mantel-Haenszel chi-square test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||14.63|-4.50|0.3005
91516663|NCT03667053|182906311|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.||||<0.001
91516664|NCT03667053|182906312|SUPERIORITY|||||||0.0073||||||Assessed at 30 minutes. Note that p-value was 0.0005 at 10 minutes and \<0.0001 at 15 and 20 minutes.|Cochran-Mantel-Haenszel|||The recovery rates of dasiglucagon and placebo were compared at each time point using a Cochran-Mantel-Haenszel test stratified by age group and injection site. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0073
91516665|NCT03667053|182906313|SUPERIORITY||||||<|0.0001||||||The p-value was \<0.0001 at all time points (10, 15, 20 and 30 minutes)|ANOVA|||Change from baseline in plasma glucose at 30, 20, 15, and 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
91516666|NCT01059565|182906346|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|0.91||||0.663|TWO_SIDED|95.0|-3.24|5.06||"To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|Baseline was included as a covariate in this model.||"The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.~A sample size of 50 participants per group provided at least 80% power to detect an 8.5% difference in mean AUCave of relative change from baseline in FEV1 % predicted through Week 24 using a two-sided 0.05-level test, assuming a common standard deviation of 15."||5.06|-3.24|0.663
91516667|NCT01059565|182906347|SUPERIORITY_OR_OTHER|||||||0.4158||||||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|Negative binomial regression|The negative binomial regression model included an offset parameter which accounted for potential differing study durations due to discontinuations.||The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.4158
91516668|NCT01059565|182906348|SUPERIORITY_OR_OTHER||Difference in LSM|0.18||||0.939|TWO_SIDED|95.0|-4.43|1.78||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||1.78|-4.43|0.939
91516669|NCT01059565|182906349|SUPERIORITY_OR_OTHER||Difference in LSM|0.77||||0.711|TWO_SIDED|95.0|-3.33|4.86|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.86|-3.33|0.711
91516670|NCT01059565|182906350|SUPERIORITY_OR_OTHER||Difference in LSM|0.6||||0.762|TWO_SIDED|95.0|-3.3|4.49|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.49|-3.30|0.762
91516671|NCT01059565|182906351|SUPERIORITY_OR_OTHER||Difference in LSM|1.95||||0.553|TWO_SIDED|95.0|-4.54|8.44|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.44|-4.54|0.553
91516672|NCT01059565|182906352|SUPERIORITY_OR_OTHER||Difference in LSM|2.99||||0.17|TWO_SIDED|95.0|-1.2|7.28|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||7.28|-1.20|0.170
91516673|NCT01059565|182906353|SUPERIORITY_OR_OTHER||Difference in LSM|-2.57||||0.528|TWO_SIDED|95.0|-10.62|5.49|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||5.49|-10.62|0.528
91516674|NCT01059565|182906354|SUPERIORITY_OR_OTHER||Difference in LSM|3.62||||0.132|TWO_SIDED|95.0|-1.11|8.34|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.34|-1.11|0.132
91516675|NCT01059565|182906355|SUPERIORITY_OR_OTHER||Difference in LSM|0.14||||0.531|TWO_SIDED|95.0|-0.29|0.56|||Mixed Models Analysis|P-value was based on a Mixed-Effect Model Repeated Measure model that included terms for treatment, visit, baseline, and treatment/visit interaction.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||0.56|-0.29|0.531
91516676|NCT01059565|182906356|SUPERIORITY_OR_OTHER||Difference in LSM|0.93||||0.232|TWO_SIDED|95.0|-0.62|2.48|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||2.48|-0.62|0.232
91516677|NCT01059565|182906357|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.103
91516678|NCT01059565|182906358|SUPERIORITY_OR_OTHER|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.646
91516679|NCT01059565|182906359|SUPERIORITY_OR_OTHER|||||||0.284|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.284
91516680|NCT01981564|182906479|SUPERIORITY|||||||0.06|||||||ANOVA|||ANOVA F=3.55, df=1, p=0.06||||0.06
91516681|NCT01869491|182906610|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.11|||Mixed Models Analysis|||||-0.11|-0.31|<0.0001
91516682|NCT01869491|182906611|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0004|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Models Analysis|||||-0.08|-0.29|0.0004
91516683|NCT01869491|182906612|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0001|TWO_SIDED|95.0|-0.32|-0.1|||Mixed Models Analysis|||||-0.10|-0.32|0.0001
91516684|NCT01869491|182906613|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0004|TWO_SIDED|95.0|-0.32|-0.09|||Mixed Models Analysis|||||-0.09|-0.32|0.0004
91516685|NCT01869491|182906614|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
91516686|NCT01869491|182906615|SUPERIORITY|||||||0.0433|||||||Wilcoxon (Mann-Whitney)|||||||0.0433
91516687|NCT01869491|182906616|SUPERIORITY|||||||0.0503|||||||Wilcoxon (Mann-Whitney)|||||||0.0503
91516688|NCT02105948|182906638|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.036|TWO_SIDED|95.0|0.68|0.98||Adjusted p-value to account for two treatment comparisons|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted for FEV1,smoking status and offset of log (time in on-and off-treatment period)|||0.98|0.68|=0.036
91516689|NCT02105948|182906638|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.029|TWO_SIDED|95.0|0.68|0.98||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||0.98|0.68|=0.029
91516690|NCT02105948|182906639|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||>|0.999|TWO_SIDED|95.0|0.85|1.12||Adjusted p-value to account for two treatment comparisons|Negative Binomial Model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|>0.999
91516691|NCT02105948|182906639|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||=|0.731|TWO_SIDED|95.0|0.85|1.12||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|=0.731
91516692|NCT02105948|182906640|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.036|TWO_SIDED|95.0|0.6|0.94||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.036
91516693|NCT02105948|182906640|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.012|TWO_SIDED|95.0|0.6|0.94||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.012
91516694|NCT02105948|182906641|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.598|TWO_SIDED|95.0|0.77|1.75||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.598
91516695|NCT02105948|182906641|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.479|TWO_SIDED|95.0|0.77|1.75||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.479
91516696|NCT02105948|182906642|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||>|0.999|TWO_SIDED|95.0|-2.8|3.2||Adjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|>0.999
91516697|NCT02105948|182906642|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||=|0.901|TWO_SIDED|95.0|-2.8|3.2||Unadjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|=0.901
91516698|NCT02105948|182906643|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||>|0.999|TWO_SIDED|95.0|-2.0|0.5||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|>0.999
91516699|NCT02105948|182906643|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||=|0.244|TWO_SIDED|95.0|-2.0|0.5||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|=0.244
91516700|NCT02105948|182906644|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||>|0.999|TWO_SIDED|95.0|0.75|1.05||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|>0.999
91516701|NCT02105948|182906644|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||=|0.16|TWO_SIDED|95.0|0.75|1.05||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|=0.160
91516702|NCT02105948|182906645|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||>|0.999|TWO_SIDED|95.0|0.81|1.49||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|>0.999
91516703|NCT02105948|182906645|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||=|0.556|TWO_SIDED|95.0|0.81|1.49||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|=0.556
91516704|NCT02105948|182906646|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||>|0.999|TWO_SIDED|95.0|-1.5|2.9||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|>0.999
91516705|NCT02105948|182906646|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||=|0.532|TWO_SIDED|95.0|-1.5|2.9||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|=0.532
91516706|NCT02105948|182906647|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||>|0.999|TWO_SIDED|95.0|-1.5|0.4||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|>0.999
91516707|NCT02105948|182906647|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||=|0.252|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|=0.252
91516708|NCT02276482|182906672|OTHER||Difference in percentages|3.6|||||TWO_SIDED|95.0|-6.3|13.5|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||13.5|-6.3|
91516709|NCT02276482|182906673|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-3.4|10.8|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||10.8|-3.4|
91516710|NCT02276482|182906674|OTHER||Difference in percentages|-4.2|||||TWO_SIDED|95.0|-12.9|4.4|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||4.4|-12.9|
91516711|NCT02276482|182906675|OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-7.4|7.7|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||7.7|-7.4|
91516712|NCT02276482|182906676|OTHER||Difference in percentages|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
91516713|NCT02005471|182906693|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified analysis: 17p deletion, risk status, geographic region.||0.29|0.18|<.0001
91516714|NCT02005471|182906693|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model|Unstratified Analysis||0.31|0.19|<.0001
91516715|NCT02005471|182906695|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.28|0.13|<.0001
91516716|NCT02005471|182906695|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.3|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.30|0.14|<.0001
91516717|NCT02005471|182906697|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.57|0.21|<.0001
91516718|NCT02005471|182906697|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.22|0.56|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.56|0.22|<.0001
91516719|NCT02005471|182906699|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.49|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.49|0.09|<.0001
91516720|NCT02005471|182906699|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.46|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.46|0.09|<.0001
91516721|NCT02005471|182906700|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
91516722|NCT02005471|182906700|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
91516723|NCT02005471|182906701|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
91516724|NCT02005471|182906701|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
91516725|NCT02005471|182906702|SUPERIORITY||Difference in Response Rates|25.07|||<|0.0001|TWO_SIDED|95.0|16.63|33.51|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.51|16.63|<.0001
91516726|NCT02005471|182906702|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.88|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.88|2.68|
91516727|NCT02005471|182906703|SUPERIORITY||Difference in Response Rates|24.55|||<|0.0001|TWO_SIDED|95.0|16.0|33.1|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.10|16.00|<.0001
91516728|NCT02005471|182906703|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.85|2.68|
91516729|NCT02005471|182906705|SUPERIORITY|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio was estimated by Cox regression model.|||0.74|0.37|0.0002
91516730|NCT02005471|182906705|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0003|TWO_SIDED|95.0|0.39|0.76|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.76|0.39|0.0003
91516731|NCT02005471|182906707|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.17|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.29|0.17|<.0001
91516732|NCT02005471|182906707|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.31|0.19|<.0001
91516733|NCT02005471|182906711|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.39|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.39|0.23|<.0001
91516734|NCT02005471|182906711|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.25|0.41|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.41|0.25|<.0001
91516735|NCT02005471|182906712|SUPERIORITY||Difference in MRD Negativity Rates|49.04|||<|0.0001|TWO_SIDED|95.0|40.44|57.64|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||57.64|40.44|<.0001
91516736|NCT02005471|182906712|SUPERIORITY||Odds Ratio (OR)|10.77|||||TWO_SIDED|95.0|6.5|17.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||17.85|6.50|
91516737|NCT02005471|182906713|SUPERIORITY||Difference in MRD negative rates|13.41|||<|0.0001|TWO_SIDED|95.0|7.99|18.82|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||18.82|7.99|<.0001
91516738|NCT02005471|182906713|SUPERIORITY||Odds Ratio (OR)|16.28|||||TWO_SIDED|95.0|3.82|69.35|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||69.35|3.82|
91516739|NCT00627705|182906724|SUPERIORITY_OR_OTHER|||||||0.449|||||||mixed effects regression models|F= 0.81||Cohen's d = 0.30||||0.449
91516740|NCT00627705|182906726|SUPERIORITY_OR_OTHER||||||<|0.001||||||Aberrant Behavior Checklist irritability subscale (F = 6.80; p = \<.001; d = .96).|Mixed effects regression models|||F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen's d was computed based on the standardized mean difference in the change from baseline to week 12.||||<.001
91516741|NCT00627705|182906728|SUPERIORITY_OR_OTHER|||||||0.141|||||||mixed effects regression models|degrees of freedom were 1, 22||F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.||||.141
91516742|NCT01410448|182906742|SUPERIORITY_OR_OTHER|||||||0.0921|||||||Regression, Logistic|||||||0.0921
91516743|NCT02091167|182906822|OTHER|||||||0.05|||||||ANOVA|||We powered for a medium effect size based on our previous study with effect size (partial ղ2) of 0.10384 for the main within-subject factor in the two-way ANOVA with repeated measures. With a power of 80%, and a two-sided probability of a type I error of 5%, the resulting minimum sample size was 30 participants. To account for waiving or dropouts we increased the estimated sample size to approximately 10%, resulting in 33 subjects in total (approximately 16 to 17 subjects in each group).|"Most of data (age, patterns of crack-cocaine use, 5-items OCCS) were normally distributed according to the D'Agostino \& Pearson normality test, thus they were analyzed by parametric tests. Between-group (sham- and real tDCS) comparisons were conducted by unpaired Student´s t-tests. For all other non-parametric data (gender, schooling, employment, marital state and tobacco use), Chi-square or Fisher tests were used to compare sham and real tDCS groups.~Besides the two-way ANOVA with repeated measures followed by Bonferroni-corrected t-tests, linear regression analyses were done over craving scores obtained along the 4-week treatment (five time-points measurements) for both groups. Additional comparisons between initial and final OCDS scores were done by paired t-tests for each group, and differences between final and initial scores were compared between sham-tDCS and real tDCS groups with unpaired t-test."|||0.05
91516744|NCT02091167|182906823|OTHER|||||||0.05|||||||Fisher Exact|||Two patients from each group were lost to follow-up after their discharge from the hospital.||||0.05
91516745|NCT02693665|182906845|SUPERIORITY|First measure of congruence was taken at 2 weeks post-baseline for controls, or immediately post-Session 2 for intervention dyads. Analysis presented here assessed differences between groups in agreement. This represents the underlying data without examining the pattern of congruence for each dyad over time. Longitudinal latent class analysis of congruence in responses over time between adolescents/families was conducted at the person not variable level.|Odds Ratio (OR)|3.22|||<|0.05|TWO_SIDED|95.0|1.09|9.57|||longitudinal latent class analysis|examined the pattern of change over time.||"Analysis was at the level of the dyad. AIM 1. To evaluate the efficacy of FACE-TC on patient-family congruence in treatment preferences.~H1a: FACE-TC participants will better maintain congruence over time, compared to controls.~H1b: Development of congruence may not be homogeneous and FACE-TC may influence the pattern of congruence development."||9.57|1.09|<0.05
91516746|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.00743162|||<|0.05|TWO_SIDED|95.0|0.928|1.094||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at baseline comparing intervention and control.||1.094|0.928|<0.05
91516747|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.05037501|||<|0.05|TWO_SIDED|95.0|0.96438584|1.14403138||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at 3 months post baseline comparing intervention and control. We hypothesized that anxiety would be lower in the intervention group compared to controls.||1.14403138|0.96438584|<0.05
91516748|NCT02693665|182906846|SUPERIORITY|See earlier comments.|Risk Ratio (RR)|1.01136067|||<|0.05|TWO_SIDED|95.0|0.92887892|1.10116656||See earlier comments.|t-test, 2 sided|See earlier comments.||This is analysis for 6 month outcomes of Emotional-distress - anxiety. See details in 3 month outcomes.||1.10116656|0.92887892|<0.05
91516749|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.14070431|||<|0.05|TWO_SIDED|95.0|1.04444724|1.2458325|||t-test, 2 sided||See earlier comments.|These are the 12 month outcomes for Emotional distress - anxiety. See earlier comments.||1.24583250|1.04444724|<0.05
91516750|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|0.98078271|||<|0.05|TWO_SIDED|95.0|0.89845609|1.07065301|||t-test, 2 sided|||This analysis is for the outcome Emotional distress - depressive symptoms. We hypothesized that adolescent in the intervention would have lower depressive symptoms compared to controls at 3, 6, and 12 month outcomes. The following are the baseline comparisons between control and intervention which were controlled for in the 3, 6, and 12 month analysis of outcomes.||1.07065301|0.89845609|<0.05
91516751|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.04007715|||<|0.05|TWO_SIDED|95.0|0.94970156|1.13905306|||t-test, 2 sided|||The results here are for the outcome variable Emotional Distress - Depressive symptoms at 3 month outcomes. We hypothesized that adolescents randomized to the intervention would have lower depressive symptoms than controls.||1.13905306|0.94970156|<0.05
91516752|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.07347088|||<|0.05|TWO_SIDED|95.0|0.9806271|1.17510491|||t-test, 2 sided|||We hypothesize that Emotional Distress - Depressive symptoms would be lower in intervention adolescents compared to controls at 6 months post intervention.||1.17510491|0.98062710|<0.05
91516753|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.11582434|||<|0.05|TWO_SIDED|95.0|1.01653156|1.22481585|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have lower scores on Emotional Distress - Depressive symptoms compared to controls at 12 months post baseline.||1.22481585|1.01653156|<0.05
91516754|NCT02693665|182906846|SUPERIORITY||Risk Ratio, log|0.98803061|||<|0.05|TWO_SIDED|95.0|0.89065531|1.09605195|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have no differences in fatigue at baseline if randomization was successful. In this analysis we examine the baseline results.||1.09605195|0.89065531|<0.05
91516755|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.13509797|||<|0.05|TWO_SIDED|95.0|1.01959639|1.26368376|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention arm would report less Fatigue at 3 months outcome compared to controls.||1.26368376|1.01959639|<0.05
91516756|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.04944737|||<|0.05|TWO_SIDED|95.0|0.94281417|1.16814089|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would report less Fatigue at 6 months post baseline compared to control adolescents.||1.16814089|0.94281417|<0.05
91516757|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.11042568|||<|0.05|TWO_SIDED|95.0|0.99383841|1.24068981|||t-test, 2 sided|||We hypothesized that intervention adolescents would report less Fatigue than controls at 12 months post baseline.||1.24068981|0.99383841|<0.05
91516758|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|0.9683347|||<|0.05|TWO_SIDED|95.0|0.88658183|1.05762611|||t-test, 2 sided|||We hypothesized that there would be no differences at baseline between intervention and control adolescents with respect to Pain Interference.||1.05762611|0.88658183|<0.05
91516759|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.04450374|||<|0.05|TWO_SIDED|95.0|0.95307464|1.1447037|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 3 months post baseline.||1.14470370|0.95307464|<0.05
91516760|NCT02693665|182906846|SUPERIORITY||Risk Ratio (RR)|1.07182133|||<|0.05|TWO_SIDED|95.0|0.97835451|1.17421748|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 6 months post baseline.||1.17421748|0.97835451|<0.05
91516761|NCT02693665|182906846|SUPERIORITY||Risk Ratio, log|1.09964781|||<|0.05|TWO_SIDED|95.0|1.00051223|1.20860622|||t-test, 2 sided|||We hypothesized that at 12 month outcome adolescents randomized to the intervention would report less Pain Interference compared to control adolescents.||1.20860622|1.00051223|<0.05
91516762|NCT02693665|182906847|SUPERIORITY||Mean ratio|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.09|||Mixed Models Analysis|||Meaning and Peace Subscale at 3 months post intervention||1.09|0.88|<0.05
91516763|NCT02693665|182906847|SUPERIORITY||Mean ratio|0.97|||<|0.05|TWO_SIDED|95.0|0.88|1.08|||Mixed Models Analysis|||Meaning and Peace subscale at 6 months post intervention||1.08|0.88|<0.05
91516764|NCT02693665|182906847|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.82|1.02|||Mixed Models Analysis|||Meaning and Peace subscale at 12 months post intervention||1.02|0.82|<0.05
91516765|NCT02693665|182906847|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.73|1.16|||Mixed Models Analysis|||Faith subscale score at 3 months post intervention||1.16|0.73|<0.05
91516766|NCT02693665|182906847|SUPERIORITY||Mean ratio|0.96|||<|0.05|TWO_SIDED|95.0|0.76|1.21|||Mixed Models Analysis|||Faith subscale at 6 months post intervention||1.21|0.76|<0.05
91516767|NCT02693665|182906847|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.72|1.17|||Mixed Models Analysis|||Faith subscale scores at 12 months post intervention||1.17|0.72|<0.05
91516768|NCT02693665|182906848|SUPERIORITY||Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED|95.0|-0.42|0.15|||GEE model|||Caregiver Strain subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.15|-0.42|<0.05
91516769|NCT02693665|182906848|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED|95.0|0.02|0.36|||GEE model|||Positive Caregiving Appraisal subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.36|0.02|<0.05
91516770|NCT02693665|182906848|SUPERIORITY||Mean Difference (Final Values)|-0.01|||<|0.05|TWO_SIDED|95.0|-0.35|0.32|||GEE model|||Caregiver Distress subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.32|-0.35|<0.05
91516771|NCT02693665|182906848|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED|95.0|-0.07|0.38|||GEE model|||Family Well-Being subscale at 3 months post-intervention, comparing intervention to TAU, controlling for baseline levels.||0.38|-0.07|<0.05
91516772|NCT02693665|182906850|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.59||0.47|TWO_SIDED||||||Regression, Linear|Intervention effect for quality of adolescent communication score controlling for age, gender, race, income and on active treatment.|It is the standard error of the slope, but this was not an option.|Quality of communication analysis for adolescents||||0.47
91516773|NCT02693665|182906850|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED||||||Regression, Linear|Testing intervention effect for family member quality of communication score controlling for age, gender, race, income nd on active treatment.|This is standard error of the slope.|Quality of communication analysis for family member.||||<0.01
91516774|NCT02693665|182906856|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.71|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent positive score comparing intervention with TAU.||||<0.05
91516775|NCT02693665|182906856|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent negative worded score comparing intervention to TAU.||||<0.05
91516776|NCT02693665|182906856|SUPERIORITY||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member positively worded score comparing intervention with treatment as usual.||||<0.05
91516777|NCT02693665|182906856|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member negative worded score comparing intervention to TAU.||||<0.05
91516778|NCT00844857|182906913|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05. Mixed Model Repeated Measures Analysis (MMRM) terms included baseline, country, treatment, visit, and treatment \* visit interaction.|Mixed Models Analysis|||"Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.~A conservative estimate of effect size of 0.4 was used in the sample size estimation for this study. A randomized ratio of 2:1 provided a 90% power with an effect size of 0.4."||||0.003
91516779|NCT00844857|182906914|SUPERIORITY_OR_OTHER|||||||0.035||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.035
91516780|NCT00844857|182906915|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.003
91516781|NCT00844857|182906916|SUPERIORITY_OR_OTHER|||||||0.007||||||The a priori threshold for statistical significance was 0.05. Ordinal Logistic Regression Model terms include baseline CDRS-R, baseline YMRS, and treatment.|Ordinal Logistic Regression|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.007
91516782|NCT00844857|182906917|SUPERIORITY_OR_OTHER|||||||0.527||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction.|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.527
91516783|NCT00844857|182906918|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.030
91516784|NCT00844857|182906919|SUPERIORITY_OR_OTHER|||||||0.002||||||The a priori threshold for statistical significance was 0.05. ANCOVA (analysis of covariance) Model terms included baseline, country, and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.002
91516785|NCT00844857|182906920|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
91516786|NCT00844857|182906921|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
91516787|NCT00844857|182906921|SUPERIORITY_OR_OTHER|||||||0.667||||||P-value for Suicidal Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.667
91516788|NCT00844857|182906921|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation or Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
91516789|NCT00844857|182906922|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
91516790|NCT00844857|182906923|SUPERIORITY_OR_OTHER|||||||0.545||||||P-value for ADHDRS-IV-PI Total Score. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.545
91516791|NCT00844857|182906924|SUPERIORITY_OR_OTHER|||||||0.066||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.066
91516792|NCT00844857|182906925|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
91516793|NCT00844857|182906926|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
91516794|NCT00844857|182906927|SUPERIORITY_OR_OTHER|||||||0.05||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.050
91516795|NCT00844857|182906928|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
91516796|NCT00844857|182906929|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for Fasting Glucose. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.980
91516797|NCT00844857|182906929|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Cholesterol. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
91516798|NCT00844857|182906929|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Triglycerides. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
91516799|NCT00844857|182906930|SUPERIORITY_OR_OTHER|||||||0.005||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.005
91516800|NCT00844857|182906931|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
91516801|NCT00844857|182906932|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
91516802|NCT00570674|182906939|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
91516803|NCT00570674|182906940|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
91516804|NCT00570674|182906941|OTHER|||||||0.52|||||||Sign test|||||||0.52
91516805|NCT00570674|182906942|OTHER|||||||0.39|||||||Sign test|||||||0.39
91516806|NCT03069482|182906943|SUPERIORITY||Slope|1.063|STANDARD_DEVIATION|3.377|=|0.754|TWO_SIDED||||||ANOVA|||||||=0.754
91516807|NCT03069482|182906944|SUPERIORITY||Risk Ratio (RR)|2.103|STANDARD_DEVIATION|0.369||0.044|TWO_SIDED|95.0|1.2|2.6|||Mixed Models Analysis|Zero inflated negative binomial mixed methods regression.||||2.6|1.2|0.044
91516808|NCT03069482|182906945|OTHER||Percent accrual relative to target N|102.0|||||TWO_SIDED||||||||||The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).|||
91516809|NCT03069482|182906946|OTHER||Percent retention relative to target|98.3|||||TWO_SIDED||||||||||We calculated the percent of retained participants relative to the retention target (N = 62)|||
91516810|NCT03069482|182906947|OTHER||Percent of respondents|58.0|||||TWO_SIDED|||||||||||||
91516811|NCT03069482|182906949|SUPERIORITY||Trimmed mean difference|8.29574|STANDARD_ERROR_OF_MEAN|2.11||0.046|TWO_SIDED|95.0|0.138|16.453|||Yuen's trimmed mean t-test|||||16.453|0.138|0.046
91516812|NCT03069482|182906950|SUPERIORITY||Trimmed mean difference|7.79514|STANDARD_ERROR_OF_MEAN|2.16||0.109|TWO_SIDED|95.0|-1.867|17.457|||Yuen's trimmed means t-test|||||17.457|-1.867|0.109
91516813|NCT03069482|182906951|SUPERIORITY||Trimmed mean difference|2.22222|STANDARD_ERROR_OF_MEAN|1.75||0.50537|TWO_SIDED|95.0|-4.492|8.943|||Yuen's trimmed means t-test|||||8.943|-4.492|0.50537
91516814|NCT03069482|182906952|SUPERIORITY||Trimmed mean difference|5.83333|STANDARD_ERROR_OF_MEAN|2.3||0.27411|TWO_SIDED|95.0|-4.88|16.54|||Yuen's trimmed means t-test|||||16.54|-4.88|0.27411
91516815|NCT00240487|182906999|NON_INFERIORITY_OR_EQUIVALENCE|The primary outcome variable is the mean PaO2/FiO2 in each group after 8 hours of study participation to determine whether timing of treatment with nitric oxide impacts outcome (immediate treatment versus delayed treatment).|||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Differences in mean PaO2/FiO2 ratios between the two groups will help to determine whether order of therapy (immediate treatment with nitric oxide versus delayed treatment with nitric oxide) impacts outcomes.||||>0.05
91516816|NCT04098939|182907007|EQUIVALENCE|Bland-Altman plots|Bland-Altman plots|0.39|||<|0.05|TWO_SIDED|95.0|0.26|1.04||Analysis of Bland-Altman plots|Bland-Altman plots|Analysis of Bland-Altman plots|||Analysis of Bland-Altman plots|1.04|0.26|<0.05
91516817|NCT01002872|182907031|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||0.037
91516818|NCT01002872|182907032|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
91516819|NCT01002872|182907033|SUPERIORITY|||||||0.897|||||||t-test, 2 sided|||||||0.897
91516820|NCT01002872|182907034|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
91516821|NCT01002872|182907035|SUPERIORITY|||||||0.416|||||||t-test, 2 sided|||||||0.416
91516822|NCT01002872|182907036|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
91516823|NCT01002872|182907037|SUPERIORITY|||||||0.955|||||||t-test, 2 sided|||||||0.955
91516824|NCT01002872|182907038|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91516825|NCT01002872|182907039|SUPERIORITY|||||||0.0066|||||||t-test, 2 sided|||||||0.0066
91516826|NCT01217073|182907103|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.71|||<|0.001|TWO_SIDED|95.0|-0.93|-0.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.50|-0.93|<0.001
91516827|NCT01217073|182907103|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.67|||<|0.001|TWO_SIDED|95.0|-0.88|-0.45||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.45|-0.88|<0.001
91516828|NCT01217073|182907103|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.49|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.27|-0.70|<0.001
91516829|NCT01217073|182907103|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.5|||<|0.001|TWO_SIDED|95.0|-0.71|-0.28||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.28|-0.71|<0.001
91516830|NCT01217073|182907103|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.28||||0.012|TWO_SIDED|95.0|-0.5|-0.06||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.06|-0.50|0.012
91516831|NCT01217073|182907104|SUPERIORITY_OR_OTHER||Difference in percentage|6.2|||||TWO_SIDED|95.0|-6.2|18.4||||||||18.4|-6.2|
91516832|NCT01217073|182907104|SUPERIORITY_OR_OTHER||Difference in percentage|12.5|||||TWO_SIDED|95.0|-0.1|24.7||||||||24.7|-0.1|
91516833|NCT01217073|182907104|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-6.5|18.0||||||||18.0|-6.5|
91516834|NCT01217073|182907104|SUPERIORITY_OR_OTHER||Difference in percentage|5.5|||||TWO_SIDED|95.0|-6.8|17.7||||||||17.7|-6.8|
91516835|NCT01217073|182907104|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-9.8|14.5||||||||14.5|-9.8|
91516836|NCT01217073|182907105|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||||4.1|-4.1|
91516837|NCT01217073|182907105|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
91516838|NCT01217073|182907105|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.0||||||||4.0|-4.1|
91516839|NCT01217073|182907105|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
91516840|NCT01217073|182907105|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-1.7|7.9||||||||7.9|-1.7|
91516841|NCT01217073|182907106|SUPERIORITY_OR_OTHER||Difference in percent|1.0|||||TWO_SIDED|95.0|-9.8|13.1||||||||13.1|-9.8|
91516842|NCT01217073|182907107|SUPERIORITY_OR_OTHER||Difference in percent|-1.4|||||TWO_SIDED|95.0|-9.1|2.6||||||||2.6|-9.1|
91516843|NCT01217073|182907108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-44.9|||<|0.001|TWO_SIDED|95.0|-59.0|-30.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-30.7|-59.0|<0.001
91516844|NCT01217073|182907108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-41.6|||<|0.001|TWO_SIDED|95.0|-55.3|-27.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-27.8|-55.3|<0.001
91516845|NCT01217073|182907108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-35.1|||<|0.001|TWO_SIDED|95.0|-48.9|-21.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-21.3|-48.9|<0.001
91516846|NCT01217073|182907108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-33.5|||<|0.001||95.0|-47.3|-19.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-19.7|-47.3|<0.001
91516847|NCT01217073|182907108|SUPERIORITY_OR_OTHER||Difference in least squares mean|-18.8||||0.009|TWO_SIDED|95.0|-32.9|-4.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-4.8|-32.9|0.009
91516848|NCT01217073|182907109|SUPERIORITY_OR_OTHER||Difference in least squares mean|-21.4|||<|0.001|TWO_SIDED|95.0|-29.4|-13.4||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-13.4|-29.4|<0.001
91516849|NCT01217073|182907109|SUPERIORITY_OR_OTHER||Difference in least squares mean|-13.5|||<|0.001|TWO_SIDED|95.0|-21.3|-5.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-5.7|-21.3|<0.001
91516850|NCT01217073|182907109|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.3|||<|0.001|TWO_SIDED|95.0|-22.2|-6.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-6.3|-22.2|<0.001
91516851|NCT01217073|182907109|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.0|||<|0.001|TWO_SIDED|95.0|-26.9|-11.2||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-11.2|-26.9|<0.001
91516852|NCT01217073|182907109|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.5||||0.539|TWO_SIDED|95.0|-10.4|5.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||5.5|-10.4|0.539
91516853|NCT03561090|182907116|SUPERIORITY||Least squares (LS) mean difference|0.055||||0.6346|TWO_SIDED|95.0|-0.172|0.281|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.281|-0.172|0.6346
91516854|NCT03561090|182907117|SUPERIORITY||LS Mean Difference|0.035||||0.7101|TWO_SIDED|95.0|-0.151|0.221|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.221|-0.151|0.7101
91516855|NCT03561090|182907118|SUPERIORITY||Difference in percentage of responders|-5.5|||||TWO_SIDED|95.0|-14.7|3.7|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||3.7|-14.7|
91516856|NCT03561090|182907118|SUPERIORITY||Odds Ratio (OR)|0.81||||0.2531|TWO_SIDED|95.0|0.56|1.17|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the CMH tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.17|0.56|0.2531
91516857|NCT03561090|182907119|SUPERIORITY||Proportion ratio|0.938||||0.7445|TWO_SIDED|95.0|0.636|1.382||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Proportion Ratio (1500 mg IW-3718 BID + PPI: Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.382|0.636|0.7445
91516858|NCT03561090|182907119|OTHER|Negative binomial model was used to deal with data overdispersion.|Difference in Proportion Ratio|-0.015|||||TWO_SIDED|95.0|-0.103|0.074|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI).|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.074|-0.103|
91516859|NCT01426191|182907192|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
91516860|NCT01426191|182907193|OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
91516861|NCT01715805|182907215|SUPERIORITY||Least Squares Mean Difference (LSMD)|-0.2||||0.7948|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine + ADT - Placebo + ADT|||1.2|-1.6|0.7948
91516862|NCT01715805|182907216|SUPERIORITY||LSMD|-0.7||||0.2784|TWO_SIDED|95.0|-1.9|0.5||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine +ADT - Placebo + ADT|||0.5|-1.9|0.2784
91516863|NCT04313634|182907225|SUPERIORITY|||||||0.611|||||||Wilcoxon (Mann-Whitney)|||||||0.611
91516864|NCT04313634|182907226|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
91516865|NCT04313634|182907227|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
91516866|NCT04313634|182907228|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
91516867|NCT04313634|182907230|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
91516868|NCT01392560|182907271|SUPERIORITY_OR_OTHER||Mean change from baseline|-19.6|STANDARD_ERROR_OF_MEAN|5.6||0.0011|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for all patients||||0.0011
91516869|NCT01392560|182907271|SUPERIORITY_OR_OTHER||Mean change from baseline|-30.8|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients||||<0.0001
91516870|NCT01392560|182907271|SUPERIORITY_OR_OTHER||Change from baseline|-33.4|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers||||<0.0001
91516871|NCT01392560|182907271|SUPERIORITY_OR_OTHER||Mean change from baseline|-44.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers||||<0.0001
91516872|NCT01392560|182907271|SUPERIORITY_OR_OTHER||Mean change from baseline|9.0|STANDARD_ERROR_OF_MEAN|5.9||0.1524|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers||||0.1524
91516873|NCT01392560|182907271|SUPERIORITY_OR_OTHER||Mean change from baseline|-2.4|STANDARD_ERROR_OF_MEAN|7.7||0.7585|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers||||0.7585
91516874|NCT02558010|182907278|SUPERIORITY||||||<|0.05||||||The p-value was calculated, and does not indicate the threshold for statistical significance.|Mixed Models Analysis|||||||<0.05
91516875|NCT03301051|182907303|OTHER|Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants \[ARV\]/attack rate in unvaccinated participants \[ARU\]) x 100%.|Vaccine Efficacy|34.9|||||TWO_SIDED|95.0|17.6|48.6|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% confidence interval (CI).|||48.6|17.6|
91516876|NCT03301051|182907304|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|38.6|||||TWO_SIDED|95.0|27.6|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|27.6|
91516877|NCT03301051|182907305|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|33.8|||||TWO_SIDED|95.0|14.9|48.5|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.5|14.9|
91516878|NCT03301051|182907306|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|37.6|||||TWO_SIDED|95.0|25.1|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|25.1|
91516879|NCT03301051|182907307|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|6.2|||||TWO_SIDED|95.0|0.8|11.3|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||11.3|0.8|
91516880|NCT01359735|182907359|SUPERIORITY_OR_OTHER|||||||0.263|TWO_SIDED|||||Week 04|Wilcoxon (Mann-Whitney)|||||||0.263
91516881|NCT01359735|182907359|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Week 13|Wilcoxon (Mann-Whitney)|||||||0.500
91516882|NCT01359735|182907360|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Over weeks 1 through 4 or Week 4?|Fisher Exact|||||||0.5
91516883|NCT01359735|182907361|SUPERIORITY_OR_OTHER|||||||0.0594|TWO_SIDED||||||Log Rank|||||||0.0594
91516884|NCT01359735|182907362|SUPERIORITY_OR_OTHER|||||||0.1354|ONE_SIDED|||||3 Weeks|t-test, 1 sided|||||||0.1354
91516885|NCT01359735|182907362|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||12 Weeks|t-test, 1 sided|||||||0.5000
91516886|NCT01359735|182907363|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED|||||Week 3 Post-surgery|t-test, 1 sided|||||||0.0841
91516887|NCT01359735|182907363|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Week 12 Post-surgery|t-test, 1 sided|||||||0.1780
91516888|NCT01358526|182907368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.163||0.0055|TWO_SIDED|95.0|0.13|0.77||A gate-keeping strategy and a Bonferroni-Holm method was used to control the family-wise (primary and secondary efficacy analysis) error rate at the 5% level.|Mixed Models Analysis|Mixed-model repeated measures analysis of pain data using a pattern mixture model framework||||0.77|0.13|0.0055
91516889|NCT01358526|182907369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.26||0.0191|TWO_SIDED|95.0|0.9|9.8|||Mixed Models Analysis|Mixed-model repeated measures analysis|Mean difference (final values) is the treatment comparison estimated using mixed model repeated measures analysis with effect for treatment, time (weeks 4, 8, 12), treatment by time interaction, and prerandomization value. Subject is a random effect.|||9.8|0.9|0.0191
91516890|NCT01358526|182907370|SUPERIORITY_OR_OTHER|||||||0.0002||||||"The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test"|Fisher Exact|||||||0.0002
91516891|NCT01358526|182907371|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 30%||||0.0006
91516892|NCT01358526|182907372|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 50%||||0.0018
91516893|NCT01462344|182907377|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.285||||0.006|TWO_SIDED|95.0|0.726|2.272|||Regression, Cox||Estimated for Hazard ratio|||2.272|0.726|0.006
91516894|NCT01462344|182907377|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0019|||||TWO_SIDED|95.0|-0.0024|0.0063|||||Estimated for Absolute risk difference|||0.0063|-0.0024|
91516895|NCT01462344|182907378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859|||||TWO_SIDED|95.0|0.729|1.012|||||Estimated for Hazard ratio|||1.012|0.729|
91516896|NCT00360529|182907385|SUPERIORITY_OR_OTHER|||||||0.0454||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 50 mg qhs versus placebo||||0.0454
91516897|NCT00360529|182907385|SUPERIORITY_OR_OTHER|||||||0.0024||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 100 mg qhs versus placebo||||0.0024
91516898|NCT00360529|182907386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2606||95.0|-1.0|3.7||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||3.7|-1.0|0.2606
91516899|NCT00360529|182907386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.066||95.0|-0.1|4.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||4.6|-0.1|0.066
91516900|NCT00360529|182907387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.1601||95.0|-2.9|0.5||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.5|-2.9|0.1601
91516901|NCT00360529|182907387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0001||95.0|-5.6|-2.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-2.2|-5.6|0.0001
91516902|NCT00360529|182907388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1144||95.0|-0.3|0.0||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.0|-0.3|0.1144
91516903|NCT00360529|182907388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0001||95.0|-0.5|-0.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-0.2|-0.5|0.0001
91516904|NCT00360529|182907389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0173||95.0|0.0|0.4|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.4|0.0|0.0173
91516905|NCT00360529|182907389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0001||95.0|0.2|0.5|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||0.5|0.2|0.0001
91516906|NCT00360529|182907390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.0071||95.0|0.4|2.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||2.6|0.4|0.0071
91516907|NCT00360529|182907390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.0001||95.0|1.4|3.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||3.6|1.4|0.0001
91516908|NCT00360529|182907391|SUPERIORITY_OR_OTHER||Percentage responders|34.7||||0.0513||95.0|29.0|40.4|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 25 mg bid versus placebo||40.4|29.0|0.0513
91516909|NCT00360529|182907391|SUPERIORITY_OR_OTHER||Percentage responders|38.6||||0.0059||95.0|32.6|44.6|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 50 mg qhs versus placebo||44.6|32.6|0.0059
91516910|NCT01218438|182907437|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.012|||<|0.0001|ONE_SIDED|99.0||0.024|||Poisson|||||0.024||<0.0001
91516911|NCT00907153|182907527|SUPERIORITY||Mean Difference (Net)|-0.017||||0.05|TWO_SIDED|95.0|-0.034|0.0|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.000|-0.034|0.05
91516912|NCT00907153|182907528|SUPERIORITY||Mean Difference (Net)|-1.14||||0.62|TWO_SIDED|95.0|-5.89|3.62|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||3.62|-5.89|0.62
91516913|NCT00907153|182907529|SUPERIORITY||Mean Difference (Net)|-3.65||||0.48|TWO_SIDED|95.0|-14.32|7.02|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.02|-14.32|0.48
91516914|NCT00907153|182907530|SUPERIORITY||Mean Difference (Net)|-6.51||||0.02|TWO_SIDED|95.0|-12.07|-0.96|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.96|-12.07|0.02
91516915|NCT00907153|182907531|SUPERIORITY||Mean Difference (Net)|6.28||||0.22|TWO_SIDED|95.0|-3.97|16.54|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||16.54|-3.97|0.22
91516916|NCT00907153|182907532|SUPERIORITY||Mean Difference (Net)|13.84||||0.33|TWO_SIDED|95.0|-210.29|37.98|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||37.98|-210.29|0.33
91516917|NCT00907153|182907533|SUPERIORITY||Mean Difference (Net)|-12.8||||0.39|TWO_SIDED|95.0|-42.94|17.34|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||17.34|-42.94|0.39
91516918|NCT00907153|182907534|SUPERIORITY||Mean Difference (Net)|-75.08||||0.09|TWO_SIDED|95.0|-161.9|11.78|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||11.78|-161.9|0.09
91516919|NCT00907153|182907535|SUPERIORITY||Mean Difference (Net)|0.73||||0.96|TWO_SIDED|95.0|-32.59|34.06|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||34.06|-32.59|0.96
91516920|NCT00907153|182907536|SUPERIORITY||Mean Difference (Net)|3.08||||0.21|TWO_SIDED|95.0|-1.84|7.99|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.99|-1.84|0.21
91516921|NCT00907153|182907537|SUPERIORITY||Mean Difference (Net)|0.11||||0.99|TWO_SIDED|95.0|-24.43|24.64|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||24.64|-24.43|0.99
91516922|NCT00907153|182907538|SUPERIORITY||Median Difference (Net)|-1.93||||0.62|TWO_SIDED|95.0|-10.12|6.26|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||6.26|-10.12|0.62
91516923|NCT00907153|182907539|SUPERIORITY||Mean Difference (Net)|0.28||||0.98|TWO_SIDED|95.0|-20.29|20.85|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||20.85|-20.29|0.98
91516924|NCT00907153|182907540|SUPERIORITY||Mean Difference (Net)|10.24||||0.64|TWO_SIDED|95.0|-34.61|55.08|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||55.08|-34.61|0.64
91516925|NCT00907153|182907541|SUPERIORITY||Mean Difference (Net)|0.88||||0.88|TWO_SIDED|95.0|-22.81|8.51|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||8.51|-22.81|0.88
91516926|NCT00907153|182907542|SUPERIORITY||Mean Difference (Net)|-3.15||||0.25|TWO_SIDED|95.0|-8.7|2.41|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||2.41|-8.70|0.25
91516927|NCT00907153|182907543|SUPERIORITY||Mean Difference (Net)|44.31|||<|0.001|TWO_SIDED|95.0|27.13|61.48|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||61.48|27.13|<0.001
91516928|NCT00907153|182907544|SUPERIORITY||Mean Difference (Net)|1.56||||0.38|TWO_SIDED|95.0|-2.08|5.2|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||5.20|-2.08|0.38
91516929|NCT00907153|182907545|SUPERIORITY||Mean Difference (Net)|-7.84||||0.46|TWO_SIDED|95.0|-29.34|13.67|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||13.67|-29.34|0.46
91516930|NCT00778648|182907549|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
91516931|NCT00713648|182907558|SUPERIORITY_OR_OTHER||Mean (Lambda)|0.048||||||95.0|0.0094|0.2501|||Poisson model (log-link)|The estimated rate was adjusted for age and overdispersion which was estimated by Pearson's chi-square statistic divided by its degrees of freedom.|Mean (Lambda) refer to the estimate of the annualised bleeding rate|||0.2501|0.0094|
91516932|NCT01552213|182907562|SUPERIORITY||Risk Ratio (RR)|0.8||||0.32|TWO_SIDED|95.0|0.53|1.24|||Chi-squared|||||1.24|0.53|0.32
91516933|NCT01552213|182907563|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
91516934|NCT01552213|182907564|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
91516935|NCT01552213|182907565|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
91516936|NCT01552213|182907566|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
91516937|NCT01552213|182907567|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
91516938|NCT01552213|182907568|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
91516939|NCT01552213|182907569|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
91516940|NCT01552213|182907570|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
91516941|NCT01552213|182907571|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
91516942|NCT01552213|182907572|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
91516943|NCT01552213|182907573|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
91516944|NCT01552213|182907574|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
91516945|NCT01552213|182907575|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
91516946|NCT02566031|182907577|SUPERIORITY||Mean Difference (Net)|0.05||||0.0129|TWO_SIDED|95.0|0.011|0.093|||ANCOVA|||||0.093|0.011|0.0129
91516947|NCT02566031|182907578|SUPERIORITY||Mean Difference (Net)|0.06||||0.0058|TWO_SIDED|95.0|0.017|0.098|||ANCOVA|||-45 min||0.098|0.017|0.0058
91516948|NCT02566031|182907578|SUPERIORITY||Mean Difference (Net)|0.05||||0.0161|TWO_SIDED|95.0|0.009|0.091|||ANCOVA|||-15min||0.091|0.009|0.0161
91516949|NCT02566031|182907579|SUPERIORITY||Mean Difference (Net)|0.31||||0.0767|TWO_SIDED|95.0|-0.033|0.646|||ANCOVA|||||0.646|-0.033|0.0767
91516950|NCT02566031|182907580|SUPERIORITY||Mean Difference (Net)|-0.81||||0.1008|TWO_SIDED|95.0|-1.77|0.16|||ANCOVA|||||0.16|-1.77|0.1008
91516951|NCT00000392|182907677|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||||||0.18
91516952|NCT02647359|182907679|OTHER||Least Square (LS) Mean Difference|10.76||||0.4868|TWO_SIDED|95.0|-21.914|43.434||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with age and baseline Maximum Reading Speed (both eyes) as covariates, and treatment as a factor.||43.434|-21.914|0.4868
91516953|NCT02219932|182907707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.006|TWO_SIDED|95.0|1.15|2.26|||Regression, Logistic||fampridine vs. placebo|Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||2.26|1.15|0.006
91516954|NCT02219932|182907707|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.104|||||TWO_SIDED|95.0|0.03|0.178||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||0.178|0.030|
91516955|NCT02219932|182907707|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||||TWO_SIDED|95.0|1.06|1.7||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||1.70|1.06|
91516956|NCT02219932|182907708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.04|2.07|||Regression, Logistic|||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||2.07|1.04|0.030
91516957|NCT02219932|182907708|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.092|||||TWO_SIDED|95.0|0.009|0.175||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||0.175|0.009|
91516958|NCT02219932|182907708|SUPERIORITY_OR_OTHER||Relative Risk|1.25|||||TWO_SIDED|95.0|0.99|1.51||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||1.51|0.99|
91516959|NCT02219932|182907709|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|0.925|<|0.001|TWO_SIDED|95.0|-5.13|-1.5|||mixed model for repeated measures|||||-1.50|-5.13|< 0.001
91516960|NCT02219932|182907710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.277||0.141|TWO_SIDED|95.0|-0.13|0.95|||mixed model for repeated measures|||||0.95|-0.13|0.141
91516961|NCT02219932|182907711|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.573||0.197|TWO_SIDED|95.0|-0.38|1.86|||mixed model for repeated measures|||||1.86|-0.38|0.197
91516962|NCT00511004|182907714|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|||||Adjusted for multiple comparisons|Fisher Exact|||||||<0.2
91516963|NCT00511004|182907715|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.9
91516964|NCT04642638|182907718|OTHER||Difference in median|6.7|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|0.0|6.7|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% confidence interval (CI).|||6.70|0.00|
91516965|NCT04642638|182907718|OTHER||Difference in median|13.3|STANDARD_ERROR_OF_MEAN|10.55|||TWO_SIDED|95.0|3.3|17.8|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||17.80|3.30|
91516966|NCT04642638|182907718|OTHER||Difference in median|-6.6|STANDARD_ERROR_OF_MEAN|-5.0|||TWO_SIDED|95.0|-10.0|0.0|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||0.00|-10.00|
91516967|NCT04642638|182907719|OTHER||Geometric Mean Fold Rise (GMFR) Ratio|2.5|||||TWO_SIDED|95.0|1.72|3.632|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||3.632|1.720|
91516968|NCT04642638|182907719|OTHER||GMFR Ratio|3.88|||||TWO_SIDED|95.0|2.638|5.7|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||5.700|2.638|
91516969|NCT04642638|182907719|OTHER||GMFR Ratio|0.68|||||TWO_SIDED|95.0|0.512|0.893|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons|||0.893|0.512|
91516970|NCT04313881|182907762|SUPERIORITY||Odds Ratio (OR)|0.876||||0.5218|TWO_SIDED|95.0|0.585|1.312||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.312|0.585|0.5218
91516971|NCT04313881|182907763|SUPERIORITY||Hazard Ratio (HR)|1.203||||0.1299|TWO_SIDED|95.0|0.947|1.528||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% confidence interval (CI) were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.528|0.947|0.1299
91516972|NCT04313881|182907765|SUPERIORITY||Odds Ratio (OR)|0.821||||0.2563|TWO_SIDED|95.0|0.584|1.155||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.155|0.584|0.2563
91516973|NCT04313881|182907767|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2191|TWO_SIDED|95.0|0.427|1.212||95% CI for transfusion independence rate was based on Clopper-Pearson exact method. 2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors.|Cochran-Mantel-Haenszel|||||1.212|0.427|0.2191
91516974|NCT04313881|182907768|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.8788|TWO_SIDED|95.0|0.746|1.285||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.285|0.746|0.8788
91516975|NCT04313881|182907769|SUPERIORITY||Odds Ratio (OR)|0.441||||0.0375|TWO_SIDED|95.0|0.203|0.96||2-sided P-value, odds ratio and its 95% CI were based on unstratified Cochran-Mantel-Haenszel (CMH) method.|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.960|0.203|0.0375
91516976|NCT04313881|182907770|SUPERIORITY||Odds Ratio (OR)|0.947||||0.795|TWO_SIDED|95.0|0.629|1.426||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||1.426|0.629|0.7950
91516977|NCT04313881|182907771|SUPERIORITY||Hazard Ratio (HR)|0.837||||0.461|TWO_SIDED|95.0|0.522|1.343||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.343|0.522|0.4610
91516978|NCT04313881|182907772|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.872|TWO_SIDED|95.0|0.802|1.297||2-sided P-value was based on stratified log-rank test, stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.297|0.802|0.8720
91516979|NCT04313881|182907773|SUPERIORITY|2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors|Odds Ratio (OR)|0.605||||0.0048|TWO_SIDED|95.0|0.428|0.857||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.857|0.428|0.0048
91516980|NCT01201629|182907830|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
91516981|NCT01201629|182907831|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
91516982|NCT02415400|182907833|NON_INFERIORITY|Non-Inferiority (NI) margin = 1.2|||||<|0.0001|||||||1-sided p-value for NI test|||Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.||||<0.0001
91516983|NCT02415400|182907833|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint||0.82|0.58|<0.0001
91516984|NCT02415400|182907834|SUPERIORITY||Hazard Ratio (HR)|1.88|||<|0.0001|TWO_SIDED|95.0|1.58|2.23|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.||2.23|1.58|<0.0001
91516985|NCT02415400|182907835|SUPERIORITY||||||<|0.0001|||||||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.||||<0.0001
91516986|NCT02415400|182907836|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0033|TWO_SIDED|95.0|0.75|0.94|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.||0.94|0.75|0.0033
91516987|NCT02415400|182907837|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.2219|TWO_SIDED|95.0|0.96|1.2|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.||1.20|0.96|0.2219
91516988|NCT02415400|182907838|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.437|TWO_SIDED|95.0|0.75|1.13|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.||1.13|0.75|0.4370
91516989|NCT02415400|182907839|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1742|TWO_SIDED|95.0|0.7|1.07|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.||1.07|0.70|0.1742
91516990|NCT03825380|182907840|NON_INFERIORITY|"Primary tested:Non-inferiority of T4032 to Lumigan® on the change from baseline in IOP using a MMRM. 3 independent models will be performed, one for each time point (8:00, 10:00~\& 16:00). The 95% CI for treatment effect (difference T4032 - Lumigan) will be estimated at Wk 12. NI will be achieved if the upper bound of the 95% CI for the difference between treatment groups (T4032 - Lumigan) is lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 \& 16:00."|Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.453|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||||0.28|-0.62|0.453
91516991|NCT01968213|182907859|SUPERIORITY||Cox Proportional Hazard|0.365|||<|0.0001|TWO_SIDED|95.0|0.295|0.451|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.451|0.295|<0.0001
91516992|NCT01968213|182907860|SUPERIORITY||Cox Proportional Hazard|0.354|||<|0.0001|TWO_SIDED|95.0|0.278|0.45|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.450|0.278|<0.0001
91516993|NCT01581281|182907874|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2636|TWO_SIDED|98.3|0.34|1.48||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons, the Bonferroni corrected level of significance is 0.017 (= 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for amitriptyline relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.48|0.34|0.2636
91516994|NCT01581281|182907874|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4821|TWO_SIDED|98.3|0.39|1.68||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.68|0.39|0.4821
91516995|NCT01581281|182907874|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6107|TWO_SIDED|98.3|0.49|1.59||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to amitriptyline. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.59|0.49|0.6107
91516996|NCT01581281|182907875|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.9137|TWO_SIDED|95.0|-6.64|5.95|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||5.95|-6.64|0.9137
91516997|NCT01581281|182907875|SUPERIORITY||Median Difference (Final Values)|-4.84||||0.1331|TWO_SIDED|95.0|-11.16|1.49|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.49|-11.16|0.1331
91516998|NCT01581281|182907875|SUPERIORITY||Mean Difference (Final Values)|4.49||||0.1011|TWO_SIDED|95.0|-0.88|9.87|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||9.87|-0.88|0.1011
91516999|NCT01581281|182907876|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.3553|TWO_SIDED|98.3|-2.59|1.15||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.15|-2.59|0.3553
91517000|NCT01581281|182907876|SUPERIORITY||Median Difference (Final Values)|-0.64||||0.4143|TWO_SIDED|98.3|-2.52|1.24||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.24|-2.52|0.4143
91517001|NCT01581281|182907876|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.9038|TWO_SIDED|98.3|-1.68|1.52||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.52|-1.68|0.9038
91517002|NCT01581281|182907877|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1557|TWO_SIDED|95.0|0.85|5.05|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.05|0.85|0.1557
91517003|NCT01581281|182907877|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0754|TWO_SIDED|95.0|0.95|5.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.62|0.95|0.0754
91517004|NCT01581281|182907877|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7611|TWO_SIDED|95.0|0.49|1.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||1.62|0.49|0.7611
91517005|NCT01581281|182907878|SUPERIORITY|||||||0.3038|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.3038
91517006|NCT01581281|182907878|SUPERIORITY|||||||1|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||1.000
91517007|NCT01581281|182907878|SUPERIORITY|||||||0.2139|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.2139
91517008|NCT00295750|182907882|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|1.9||||||97.5|-1.8|5.7||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.7|-1.8|
91517009|NCT00295750|182907882|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|0.9||||||97.5|-3.2|5.0||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.0|-3.2|
91517010|NCT00295750|182907883|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91517011|NCT00295750|182907883|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91517012|NCT00295750|182907884|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91517013|NCT00295750|182907884|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
91517014|NCT00295750|182907886|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
91517015|NCT00295750|182907886|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
91517016|NCT00295750|182907886|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
91517017|NCT00295750|182907886|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
91517018|NCT00295750|182907887|SUPERIORITY_OR_OTHER||Cumulative probability|85.8||||||95.0|79.8|90.1|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.1|79.8|
91517019|NCT00295750|182907887|SUPERIORITY_OR_OTHER||Cumulative probability|91.1||||||95.0|85.9|94.5|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||94.5|85.9|
91517020|NCT00295750|182907887|SUPERIORITY_OR_OTHER||Cumulative probability|85.9||||||95.0|79.9|90.2|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.2|79.9|
91517021|NCT00584727|182907906|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20||||<0.0001
91517022|NCT00584727|182907907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7155|STANDARD_ERROR_OF_MEAN|0.1334||||95.0|0.3625|0.7155|||Mixed Models Analysis||Mean difference was senofilcon A toric minus etafilcon A sphere.|Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||0.7155|0.3625|
91517023|NCT00584727|182907908|SUPERIORITY_OR_OTHER|||||||0.2161||95.0|||||Chi-squared|||Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.||||0.2161
91517024|NCT00584727|182907909|SUPERIORITY_OR_OTHER|||||||0.1328||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees||||0.1328
91517025|NCT00584727|182907910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.489|STANDARD_ERROR_OF_MEAN|0.1393||||95.0|0.1529|0.489|||Mixed Models Analysis||Mean difference was senofilcon A toric minus alphafilcon A toric|Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.||0.4890|0.1529|
91517026|NCT00584727|182907911|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||||<0.0001
91517027|NCT02512575|182907995|SUPERIORITY_OR_OTHER||Slope|0.847|STANDARD_ERROR_OF_MEAN|0.0238|||TWO_SIDED|90.0|0.807|0.887||||||||0.887|0.807|
91517028|NCT02512575|182907998|SUPERIORITY_OR_OTHER||Slope|0.93|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.869|0.991||||||||0.991|0.869|
91517029|NCT02512575|182907999|SUPERIORITY_OR_OTHER||Slope|0.917|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.856|0.978||||||||0.978|0.856|
91517030|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.03|||||TWO_SIDED|90.0|0.96|1.11||||||||1.11|0.960|
91517031|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.0|||||TWO_SIDED|90.0|0.929|1.08||||||||1.08|0.929|
91517032|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|90.0|0.987|1.14||||||||1.14|0.987|
91517033|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|95.0|0.983|1.13||||||||1.13|0.983|
91517034|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.07|||||TWO_SIDED|90.0|0.995|1.15||||||||1.15|0.995|
91517035|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.17|||||TWO_SIDED|90.0|1.09|1.25||||||||1.25|1.09|
91517036|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.15|||||TWO_SIDED|90.0|1.07|1.24||||||||1.24|1.07|
91517037|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.2|||||TWO_SIDED|90.0|1.11|1.29||||||||1.29|1.11|
91517038|NCT02512575|182908000|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.19|||||TWO_SIDED|90.0|1.11|1.27||||||||1.27|1.11|
91517039|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.872|1.26||||||||1.26|0.872|
91517040|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.874|1.26||||||||1.26|0.874|
91517041|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.745|1.1||||||||1.10|0.745|
91517042|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.914|||||TWO_SIDED|90.0|0.762|1.1||||||||1.10|0.762|
91517043|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.876|||||TWO_SIDED|90.0|0.728|1.05||||||||1.05|0.728|
91517044|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.86|||||TWO_SIDED|90.0|0.716|1.03||||||||1.03|0.716|
91517045|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.01|||||TWO_SIDED|90.0|0.842|1.21||||||||1.21|0.842|
91517046|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.02|||||TWO_SIDED|90.0|0.846|1.22||||||||1.22|0.846|
91517047|NCT02512575|182908001|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.687|||||TWO_SIDED|90.0|0.572|0.825||||||||0.825|0.572|
91517048|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.982|||||TWO_SIDED|90.0|0.861|1.12||||||||1.12|0.861|
91517049|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.961||||||90.0|0.846|1.09||||||||1.09|0.846|
91517050|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.942|||||TWO_SIDED|90.0|0.829|1.07||||||||1.07|0.829|
91517051|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.861|||||TWO_SIDED|90.0|0.757|0.979||||||||0.979|0.757|
91517052|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.848|||||TWO_SIDED|90.0|0.745|0.964||||||||0.964|0.745|
91517053|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.927|||||TWO_SIDED|90.0|0.815|1.05||||||||1.05|0.815|
91517054|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.798|1.03||||||||1.03|0.798|
91517055|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.893|||||TWO_SIDED|90.0|0.784|1.02||||||||1.02|0.784|
91517056|NCT02512575|182908002|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.691||||||90.0|0.608|0.785||||||||0.785|0.608|
91517057|NCT04773587|182908026|SUPERIORITY||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.881|4.647|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.647|1.881|<0.0001
91517058|NCT04773587|182908027|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.359|||Cochran-Mantel-Haenszel|Stratified by pooled study site with multiple imputation of missing observations|Stratified by pooled study site with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.359|1.640|<0.0001
91517059|NCT04773587|182908028|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0089|TWO_SIDED|95.0|1.186|3.319|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 4||3.319|1.186|0.0089
91517060|NCT04773587|182908029|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0016|TWO_SIDED|95.0|1.45|5.457|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 2||5.457|1.450|0.0016
91517061|NCT04773587|182908030|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0159|TWO_SIDED|95.0|1.161|12.511|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 1||12.511|1.161|0.0159
91517062|NCT04773587|182908031|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|2.102|4.795|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|EASI-75 at Week 4||4.795|2.102|<0.0001
91517063|NCT04773587|182908032|SUPERIORITY||Odds Ratio (OR)|2.56|||<|0.0001|TWO_SIDED|95.0|1.707|3.843|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study stie and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||3.843|1.707|<0.0001
91517064|NCT04773587|182908033|SUPERIORITY||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.31|7.926|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 2||7.926|2.310|<0.0001
91517065|NCT04773587|182908034|SUPERIORITY||Odds Ratio (OR)|25.41|||<|0.0001|TWO_SIDED|95.0|2.815|229.388|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 1||229.388|2.815|<0.0001
91517066|NCT04773587|182908035|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.0001|TWO_SIDED|95.0|2.217|5.911|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.911|2.217|<0.0001
91517067|NCT04773587|182908036|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.705|7.007|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||7.007|1.705|0.0002
91517068|NCT02625623|182908074|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8078|TWO_SIDED|95.0|0.88|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.41|0.88|0.8078
91517069|NCT02625623|182908075|SUPERIORITY||Hazard Ratio (HR)|1.73||||1|TWO_SIDED|95.0|1.36|2.21|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||2.21|1.36|1.0000
91517070|NCT02625623|182908077|SUPERIORITY||Odds Ratio (OR)|0.709||||0.8764|||||||Cochran-Mantel-Haenszel|The treatment arms were compared by 1-sided CMH test. The stratification factor was region (Asia versus non Asia).||||||0.8764
91517071|NCT01316926|182908090|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9204|||||TWO_SIDED|90.0|0.8556|0.99|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||0.9900|0.8556|
91517072|NCT01316926|182908091|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.941|||||TWO_SIDED|90.0|0.846|1.0467|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||1.0467|0.8460|
91517073|NCT01316926|182908092|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9333|||||TWO_SIDED|90.0|0.8502|1.0246|||||Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.|||1.0246|0.8502|
91517074|NCT02298192|182908093|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.|Treatment Contrast|0.12||||0.012|TWO_SIDED|95.0|-0.04|0.28|||Mixed Models Analysis|||The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.||0.28|-0.04|0.012
91517075|NCT02352948|182908101|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.42|0.93|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||0.93|0.42|
91517076|NCT02352948|182908101|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.109|TWO_SIDED|95.0|0.61|1.05|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.05|0.61|0.109
91517077|NCT02352948|182908102|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||1.04|0.49|
91517078|NCT02352948|182908102|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.056|TWO_SIDED|95.0|0.59|1.01|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.01|0.59|0.056
91517079|NCT02352948|182908103|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.74|1.3|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.30|0.74|0.885
91517080|NCT02352948|182908103|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.153|TWO_SIDED|95.0|0.56|1.11|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||1.11|0.56|0.153
91517081|NCT02352948|182908104|SUPERIORITY|||||||0.063||||||The z-test statistic is the ratio of log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by square root of the variance.|z-test|The variance is estimated using the delta method and Greenwood's formula.||For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||||0.063
91517082|NCT02352948|182908105|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.282|TWO_SIDED|95.0|0.68|1.12|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.12|0.68|0.282
91517083|NCT02352948|182908105|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.011|TWO_SIDED|95.0|0.49|0.92|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||0.92|0.49|0.011
91517084|NCT02352948|182908106|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Odds Ratio (OR)|3.87|||||TWO_SIDED|95.0|1.61|10.1|||||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||10.10|1.61|
91517085|NCT02352948|182908106|SUPERIORITY||Odds Ratio (OR)|2.43||||0.037|TWO_SIDED|95.0|1.1|5.94|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||5.94|1.10|0.037
91517086|NCT02352948|182908106|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED|95.0|0.51|1.89|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.89|0.51|0.923
91517087|NCT02352948|182908106|SUPERIORITY||Odds Ratio (OR)|2.46||||0.109|TWO_SIDED|95.0|0.91|8.61|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||8.61|0.91|0.109
91517088|NCT02352948|182908110|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.002|TWO_SIDED|95.0|0.49|0.85|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||0.85|0.49|0.002
91517089|NCT05054816|182908162|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections.||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
91517090|NCT05054816|182908163|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
91517091|NCT05054816|182908164|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
91517092|NCT05054816|182908165|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between two conditions: investigative feature, comparative feature 1|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
91517093|NCT05054816|182908166|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
91517094|NCT02010060|182908169|SUPERIORITY|||||||0.074|||||||ANCOVA|||||||0.074
91517095|NCT02010060|182908169|SUPERIORITY|||||||0.684|||||||ANCOVA|||Change in waist circumference between AERO and CON||||0.684
91517096|NCT02010060|182908169|SUPERIORITY|||||||0.18|||||||ANCOVA|||Comparison between the AERO group and the AERO-PA group||||0.180
91517097|NCT02010060|182908170|SUPERIORITY|||||||0.011|||||||ANCOVA|||Change in body fat between the AERO-PA group and the CON group||||0.011
91517098|NCT02010060|182908170|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
91517099|NCT02010060|182908170|SUPERIORITY|||||||0.258|||||||ANCOVA|||Change in body fat between the AERO and AERO-PA group||||0.258
91517100|NCT02010060|182908171|SUPERIORITY|||||||0.104|||||||ANCOVA|||Comparison of body weight between the CON and AERO-PA groups||||0.104
91517101|NCT02010060|182908171|SUPERIORITY|||||||0.578|||||||ANCOVA|||Change in body weight between the CON and AERO groups||||0.578
91517102|NCT02010060|182908171|SUPERIORITY|||||||0.3|||||||ANCOVA|||Change in body weight between the AERO and AERO-PA groups||||0.300
91517103|NCT02010060|182908172|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.002
91517104|NCT02010060|182908172|SUPERIORITY|||||||0.314|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) AERO and CON groups||||0.314
91517105|NCT02010060|182908172|SUPERIORITY|||||||0.041|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.041
91517106|NCT02010060|182908173|SUPERIORITY|||||||0.891|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO-PA groups||||0.891
91517107|NCT02010060|182908173|SUPERIORITY|||||||0.417|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO groups||||0.417
91517108|NCT02010060|182908173|SUPERIORITY|||||||0.484|||||||ANCOVA|||Change in insulin sensitivity between the AERO and AERO-PA groups||||0.484
91517109|NCT02010060|182908174|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and the AERO groups||||0.274
91517110|NCT02010060|182908174|SUPERIORITY|||||||0.461|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and AERO groups||||0.461
91517111|NCT02010060|182908174|SUPERIORITY|||||||0.739|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between AERO and AERO-PA groups||||0.739
91517112|NCT02010060|182908175|SUPERIORITY|||||||0.837|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO-PA group||||0.837
91517113|NCT02010060|182908175|SUPERIORITY|||||||0.895|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO groups||||0.895
91517114|NCT02010060|182908175|SUPERIORITY|||||||0.744|||||||ANCOVA|||||||0.744
91517115|NCT02010060|182908176|SUPERIORITY|||||||0.067|||||||ANCOVA|||Change in total cholesterol (mg/dL)||||0.067
91517116|NCT02010060|182908176|SUPERIORITY|||||||0.254|||||||ANCOVA|||Change in total cholesterol (mg/dL) between the CON and AERO groups||||0.254
91517117|NCT02010060|182908176|SUPERIORITY|||||||0.501|||||||ANCOVA|||Change in total cholesterol (mg/dL) between AERO and AERO-PA groups||||0.501
91517118|NCT02010060|182908177|SUPERIORITY|||||||0.456|||||||ANCOVA|||Change in triglyceride level between the AERO-PA and CON groups||||0.456
91517119|NCT02010060|182908177|SUPERIORITY|||||||0.422|||||||ANCOVA|||Change in triglyceride level between the CON and AERO groups||||0.422
91517120|NCT02010060|182908177|SUPERIORITY|||||||0.136|||||||ANCOVA|||Change in triglyceride level between the AERO and AERO-PA groups||||0.136
91517121|NCT02010060|182908178|SUPERIORITY|||||||0.483|||||||ANCOVA|||Change in glucose level between the CON and AERO-PA groups||||0.483
91517122|NCT02010060|182908178|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in glucose between the CON and AERO groups||||0.274
91517123|NCT02010060|182908178|SUPERIORITY|||||||0.685|||||||ANCOVA|||Change in glucose level between the AERO and AERO-PA groups||||0.685
91517124|NCT02010060|182908179|SUPERIORITY|||||||0.489|||||||ANCOVA|||Change in systemic inflammation between CON and AERO-PA groups||||0.489
91517125|NCT02010060|182908179|SUPERIORITY|||||||0.652|||||||ANCOVA|||Change in systemic inflammation between the CON and AERO groups||||0.652
91517126|NCT02010060|182908179|SUPERIORITY|||||||0.822|||||||ANCOVA|||Change in systemic inflammation between the AERO and AERO-PA groups||||0.822
91517127|NCT02010060|182908180|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the CON group and the AERO-PA group||||<0.001
91517128|NCT02010060|182908180|SUPERIORITY|||||||0.648|||||||ANCOVA|||Changes in steps between the CON and the AERO group||||0.648
91517129|NCT02010060|182908180|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the AERO and AERO-PA groups||||<0.001
91517130|NCT02010060|182908181|SUPERIORITY|||||||0.226|||||||ANCOVA|||Change in kilocalories (dietary intake) between CON and AERO-PA group||||0.226
91517131|NCT02010060|182908181|SUPERIORITY|||||||0.215|||||||ANCOVA|||Change in caloric intake between the CON and the AERO groups||||0.215
91517132|NCT02010060|182908181|SUPERIORITY|||||||0.957|||||||ANCOVA|||Change in caloric intake (kilocalories) between the AERO and AERO-PA groups||||0.957
91517133|NCT02010060|182908182|SUPERIORITY|||||||0.337|||||||ANCOVA|||Change in insulin concentration between the CON and AERO-PA group||||0.337
91517134|NCT02010060|182908182|SUPERIORITY|||||||0.77|||||||ANCOVA|||Change in insulin level between the AERO and CON groups||||0.770
91517135|NCT02010060|182908182|SUPERIORITY|||||||0.515|||||||ANCOVA|||Change in insulin concentration between AERO and AERO-PA groups||||0.515
91517136|NCT01292603|182908206|NON_INFERIORITY_OR_EQUIVALENCE|A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.|Adjusted geometric mean ratio|1.533|||||TWO_SIDED|90.0|1.269|1.852|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.852|1.269|
91517137|NCT01292603|182908207|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.979|1.242|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.242|0.979|
91517138|NCT01292603|182908208|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.719|||||TWO_SIDED|90.0|0.653|0.792|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||0.792|0.653|
91517139|NCT01292603|182908209|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|14.884|||||TWO_SIDED|90.0|11.215|19.755|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||19.755|11.215|
91517140|NCT01292603|182908210|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.895|1.139|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.139|0.895|
91517141|NCT01043432|182908220|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Regression, Linear|||Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.||||>.05
91517142|NCT04307004|182908221|SUPERIORITY|The threshold for statistical significance was p = 0.05|Mean Difference (Final Values)|0.8|||<|0.0001|TWO_SIDED|95.0|0.5|1.1|||Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure when attended - mean systolic blood pressure when not attended (i.e., unattended).|||1.1|0.5|< 0.0001
91517143|NCT04307004|182908221|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure when attended - mean diastolic blood pressure when not attended (i.e., unattended)|||0.7|0.3|< 0.0001
91517144|NCT04307004|182908222|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.5||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure on ambulatory blood pressure monitoring - mean systolic blood pressure on home blood pressure monitoring.|||-1.5|-3.0|< 0.0001
91517145|NCT04307004|182908222|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.4||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure on ambulatory blood pressure monitoring - mean diastolic blood pressure on home blood pressure monitoring.|||-1.4|-2.5|< 0.0001
91517146|NCT04307004|182908224|OTHER|Independent variable - Attended systolic blood pressure. Dependent variable - Left ventricular mass index.|beta coefficient|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Linear|||We determined the association between attended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.32|< 0.001
91517147|NCT04307004|182908224|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.24|0.6|||Regression, Linear|||We determined the association between attended diastolic blood pressure measurements and left ventricular mass index (LVMI). This analysis included 587 with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.60|0.24|< 0.001
91517148|NCT04307004|182908224|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.33|0.56|||Regression, Linear|||We determined the association between unattended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.56|0.33|< 0.001
91517149|NCT04307004|182908224|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.19|0.55|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.19|< 0.001
91517150|NCT04307004|182908224|OTHER|Independent variable - awake systolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.47|0.74|||Regression, Linear|||We determined the association between awake systolic blood pressure from ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.74|0.47|< 0.001
91517151|NCT04307004|182908224|OTHER|Independent variable - awake diastolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.25|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|0.25|< 0.001
91517152|NCT04307004|182908224|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - left ventricular mass index.|beta coefficient|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.19|0.44|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with HBPM data and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.44|0.19|< 0.001
91517153|NCT04307004|182908224|OTHER|Independent variable - asleep diastolic blood pressure on HBPM Dependent variable - left ventricular mass index|beta coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED|95.0|0.05|0.4|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on HBPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|0.05|0.01
91517154|NCT04307004|182908224|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.32|0.59|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.59|0.32|< 0.001
91517155|NCT04307004|182908224|OTHER|Independent variable - asleep diastolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.16|0.55|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.16|< 0.001
91517156|NCT04307004|182908225|OTHER|Independent variable - attended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.17|TWO_SIDED|95.0|-0.47|0.08|||Regression, Linear|||We determined the association between attended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.08|-0.47|0.17
91517157|NCT04307004|182908225|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED|95.0|-0.7|0.15|||Regression, Linear|||We determined the association between attended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.15|-0.70|0.20
91517158|NCT04307004|182908225|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.07|TWO_SIDED|95.0|-0.55|0.02|||Regression, Linear|||We determined the association between unattended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.02|-0.55|0.07
91517159|NCT04307004|182908225|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.09|TWO_SIDED|95.0|-0.8|0.06|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended diastolic blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.06|-0.80|0.09
91517160|NCT04307004|182908225|OTHER|"Independent variable - awake systolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.94|TWO_SIDED|95.0|-0.29|0.31|||Regression, Linear|||We determined the association between awake systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.31|-0.29|0.94
91517161|NCT04307004|182908225|OTHER|"Independent variable - awake diastolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.22|STANDARD_ERROR_OF_MEAN|0.22||0.31|TWO_SIDED|95.0|-0.21|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|-0.21|0.31
91517162|NCT04307004|182908225|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.94|TWO_SIDED|95.0|-0.28|0.26|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.26|-0.28|0.94
91517163|NCT04307004|182908225|OTHER|Independent variable - asleep diastolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.93|TWO_SIDED|95.0|-0.4|0.36|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.36|-0.40|0.93
91517164|NCT04307004|182908225|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.54|TWO_SIDED|95.0|-0.21|0.4|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|-0.21|0.54
91517165|NCT04307004|182908225|OTHER|Independent variable - asleep diastolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.26|STANDARD_ERROR_OF_MEAN|0.21||0.23|TWO_SIDED|95.0|-0.16|0.68|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.68|-0.16|0.23
91517166|NCT01972841|182908238|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.072|TWO_SIDED|95.0|-0.49|-0.01||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.49|0.072
91517167|NCT01972841|182908238|SUPERIORITY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.033|TWO_SIDED|95.0|-0.44|0.04||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.04|-0.44|0.033
91517168|NCT01972841|182908238|SUPERIORITY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.001|TWO_SIDED|95.0|-0.58|-0.1|||Stratified rank ANCOVA||Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.58|0.001
91517169|NCT01972841|182908238|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.052|TWO_SIDED|95.0|-0.47|0.01|||Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.47|0.052
91517170|NCT01972841|182908239|SUPERIORITY||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|95.0|-0.57|-0.01||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.57|0.040
91517171|NCT01972841|182908239|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.006|TWO_SIDED|95.0|-0.67|-0.11||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.67|0.006
91517172|NCT01972841|182908239|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.76|-0.21||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.76|0.001
91517173|NCT01972841|182908239|SUPERIORITY||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.84|-0.28||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-0.84|<0.001
91517174|NCT01972841|182908240|SUPERIORITY||Least squares mean difference|3.85|STANDARD_ERROR_OF_MEAN|3.13||0.219|TWO_SIDED|95.0|-2.29|10.0||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||10.00|-2.29|0.219
91517175|NCT01972841|182908240|SUPERIORITY||Least squares mean difference|8.75|STANDARD_ERROR_OF_MEAN|3.13||0.005|TWO_SIDED|95.0|2.61|14.89||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||14.89|2.61|0.005
91517176|NCT01972841|182908240|SUPERIORITY||Least squares mean difference|21.52|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|15.35|27.68||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||27.68|15.35|<0.001
91517177|NCT01972841|182908240|SUPERIORITY||Least squares mean difference|17.74|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|11.58|23.9||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||23.90|11.58|<0.001
91517178|NCT01972841|182908241|SUPERIORITY||Least squares mean difference|-4.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-6.98|-2.27|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-2.27|-6.98|<0.001
91517179|NCT01972841|182908241|SUPERIORITY||Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.17|-3.44|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.44|-8.17|<0.001
91517180|NCT01972841|182908241|SUPERIORITY||Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.5|-4.76|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-4.76|-9.50|<0.001
91517181|NCT01972841|182908241|SUPERIORITY||Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.46|-3.74|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.74|-8.46|<0.001
91517182|NCT01972841|182908242|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.14||0.077|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.52|-0.03|0.077
91517183|NCT01972841|182908242|SUPERIORITY||Least squares mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|95.0|0.0|0.55|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.55|0.00|0.050
91517184|NCT01972841|182908242|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.008
91517185|NCT01972841|182908242|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.007
91517186|NCT01972841|182908243|SUPERIORITY||Rate ratio|0.87|STANDARD_ERROR_OF_MEAN|0.09||0.135|TWO_SIDED|95.0|0.72|1.04|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.04|0.72|0.135
91517187|NCT01972841|182908243|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.282|TWO_SIDED|95.0|0.75|1.09|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.09|0.75|0.282
91517188|NCT01972841|182908243|SUPERIORITY||Rate ratio|0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.59|0.85|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||0.85|0.59|<0.001
91517189|NCT01972841|182908243|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.1||0.172|TWO_SIDED|95.0|0.73|1.06|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.06|0.73|0.172
91517190|NCT01972841|182908244|SUPERIORITY||least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.83||0.074|TWO_SIDED|95.0|-3.27|-0.01|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.||-0.01|-3.27|0.074
91517191|NCT01972841|182908244|SUPERIORITY||Least squares mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.83||0.025|TWO_SIDED|95.0|-2.96|0.3|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.30|-2.96|0.025
91517192|NCT01972841|182908244|SUPERIORITY||least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.0|-0.73|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.73|-4.00|<0.001
91517193|NCT01972841|182908244|SUPERIORITY||Least squares mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.23|0.05|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.05|-3.23|0.024
91517194|NCT01972841|182908248|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.29||0.52|TWO_SIDED|95.0|-0.39|0.76|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.76|-0.39|0.520
91517195|NCT01972841|182908248|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.413|TWO_SIDED|95.0|-0.82|0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.34|-0.82|0.413
91517196|NCT01972841|182908248|SUPERIORITY||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.5|-0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.34|-1.50|0.002
91517197|NCT01972841|182908248|SUPERIORITY||Least squares mean diffrence|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.13|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.02|-1.13|0.060
91517198|NCT01972841|182908249|SUPERIORITY||Rate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.7|1.04|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.04|0.70|0.110
91517199|NCT01972841|182908249|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.1||0.288|TWO_SIDED|95.0|0.73|1.1|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.10|0.73|0.288
91517200|NCT01972841|182908249|SUPERIORITY||Rate ratio|0.65|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.53|0.79|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||0.79|0.53|<0.001
91517201|NCT01972841|182908249|SUPERIORITY||Rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.1||0.084|TWO_SIDED|95.0|0.68|1.02|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.02|0.68|0.084
91517202|NCT01972841|182908250|SUPERIORITY||Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.76||0.114|TWO_SIDED|95.0|-3.09|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.09|0.114
91517203|NCT01972841|182908250|SUPERIORITY||Least squares mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.76||0.034|TWO_SIDED|95.0|-3.1|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.10|0.034
91517204|NCT01972841|182908250|SUPERIORITY||Least squares mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-4.09|-1.12|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-1.12|-4.09|<0.001
91517205|NCT01972841|182908250|SUPERIORITY||Least squares mean difference|-2.21|STANDARD_ERROR_OF_MEAN|0.76||0.012|TWO_SIDED|95.0|-3.7|-0.71|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.71|-3.70|0.012
91517206|NCT01972841|182908251|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.134|TWO_SIDED|95.0|-0.46|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.46|0.134
91517207|NCT01972841|182908251|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.043|TWO_SIDED|95.0|-0.45|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.45|0.043
91517208|NCT01972841|182908251|SUPERIORITY||Least squares mean diffeence|-0.37|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.59|-0.15|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.15|-0.59|<0.001
91517209|NCT01972841|182908251|SUPERIORITY||Standard Error of the Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.11||0.019|TWO_SIDED|5.0|-0.54|-0.1|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.54|0.019
91517210|NCT01972841|182908252|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.074|TWO_SIDED|95.0|-0.69|0.03|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.03|-0.69|0.074
91517211|NCT01972841|182908252|SUPERIORITY||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.09|-0.82|0.014
91517212|NCT01972841|182908252|SUPERIORITY||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.01|-0.28|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-1.01|<0.001
91579722|NCT01655693|183049056|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.796|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Follow-up 45 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||0.796
91579723|NCT01655693|183049057|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7|TWO_SIDED|95.0||||Treatment comparison with BCS using non-stratified Log-rank test at significance level p=0.05.|Log Rank||Hazard ratio for treatment variable was determined by Cox model. The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) and type II error rate as 15%.|PFS was estimated using Kaplan-Meier methods and plotted as curves by treatment group. For comparison between treatment groups (pooled DT 20 mg/m2 and 30 mg/m2 versus BSC) used Log-rank test as primary analysis. Hazard ratio, mean, and mean PFS rate were given with corresponding 95% CI.||||0.7
91579724|NCT01655693|183049058|SUPERIORITY|||||||1||||||Treatment comparison with BCS using Fisher's exact test at significance level p=0.05.|Fisher Exact|||The comparisons between groups (pooled DT 20 mg/m2 and 30mg/m2 versus BSC) used Fisher's exact test.||||1.0
91579725|NCT01163292|183049106|SUPERIORITY_OR_OTHER|||||||0.144||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.144
91579726|NCT01163292|183049106|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.004
91579727|NCT01163292|183049106|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.006
91579728|NCT01163292|183049107|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Fisher Exact|||Week 0||||0.290
91579729|NCT01163292|183049107|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Week 26||||1.000
91579730|NCT01163292|183049107|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||Week 52||||0.001
91579731|NCT01163292|183049108|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Wilcoxon Rank Sum|||||||0.335
91579732|NCT01163292|183049109|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.266
91579733|NCT01163292|183049109|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.440
91579734|NCT01163292|183049109|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.609
91579735|NCT02643472|183049128|SUPERIORITY|||||||0.73|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.73
91579736|NCT02643472|183049129|SUPERIORITY|||||||0.12|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||STAI Y-1 data was used in these statistical analyses.||||0.12
91579737|NCT02643472|183049130|SUPERIORITY|||||||0.03|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.03
91579738|NCT02643472|183049133|SUPERIORITY|||||||0.06|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.06
91579739|NCT02643472|183049134|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
91579740|NCT02643472|183049135|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
91579741|NCT02643472|183049136|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
91579742|NCT02643472|183049137|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Cognitive subscale.||||0.92
91579743|NCT02643472|183049137|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Language subscale.||||0.58
91579744|NCT02643472|183049137|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Motor subscale.||||0.87
91579745|NCT02310100|183049157|OTHER|This is a one-group comparison to a performance goal.|binomial proportion|0.673||||0.0008|ONE_SIDED|95.0|0.608||||Exact binomial|||H0: PE ≤ 54.9% Ha: PE \> 54.9% Where PE is the primary effectiveness endpoint rate.|||0.608|0.0008
91579746|NCT02310100|183049158|OTHER|One group comparison to a performance goal.|binomial proportion|0.081||||0.0013|ONE_SIDED|95.0||0.124|||Exact binomial|||H0: PS ≥ 16.2% Ha: PS \< 16.2% where PS is the primary safety endpoint rate||0.124||0.0013
91579747|NCT00673400|183049159|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Lifestyle (LS)||||0.1340
91579748|NCT00673400|183049159|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||based on 29 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Coping/behavior (C/B)||||0.088
91579749|NCT00673400|183049159|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Depression/self-perception (D/S)||||0.0012
91579750|NCT00673400|183049159|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Embarrassment (E)||||0.0074
91579751|NCT00673400|183049162|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
91579752|NCT00673400|183049162|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
91579753|NCT00673400|183049162|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
91579754|NCT00673400|183049163|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
91579755|NCT00673400|183049163|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
91579756|NCT00673400|183049163|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
91579757|NCT00673400|183049164|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Physical component summary (PCS)||||0.65
91579758|NCT00673400|183049164|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Mental component summary (MCS)||||0.010
91579759|NCT01680640|183049165|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_DEVIATION|0.8|=|0.05|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|Regression, Linear|||A total sample size of 100 participants, with a 14% drop out during the study and 43 participants in each group completing the study provided 85% power to detect a difference of 40% in liver fat (in the treatment arm compared with the placebo), using a power calculation test with a 0.05 two-sided significance level. For change in liver fat percentage (and other secondary outcomes), ANCOVA will also be undertaken to assess effect sizes in the intervention group and placebo.||||=0.05
91579760|NCT01680640|183049165|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
91579761|NCT01680640|183049166|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end-of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.1||||1|TWO_SIDED||||||Regression, Linear|||||||1.00
91579762|NCT01680640|183049167|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED||||||Regression, Linear|||||||0.80
91579763|NCT01680640|183049168|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|0.97|||<|0.001|TWO_SIDED||||||Beta-diversity indexes|Beta-diversity indexes were first visualized through a Principal Coordinates Analysis (PCoA)||||||<0.001
91579764|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 4||3.3|-6.8|
91579765|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 6B||4.3|-4.6|
91579766|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 9V||3.3|-6.8|
91579767|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 14||4.3|-4.6|
91579768|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 18C||4.3|-4.6|
91579769|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 19F||3.3|-6.8|
91579770|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-5.0|||||TWO_SIDED|95.0|-12.3|-0.3|||Chan and Zhang|||Common serotypes - serotype 23F||-0.3|-12.3|
91579771|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|96.3|||||TWO_SIDED|95.0|89.4|99.2|||Chan and Zhang|||Additional serotypes - serotype 1||99.2|89.4|
91579772|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.1|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 3||98.6|87.7|
91579773|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|37.2|||||TWO_SIDED|95.0|26.2|48.9|||Chan and Zhang|||Additional serotypes - serotype 5||48.9|26.2|
91579774|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|22.9|||||TWO_SIDED|95.0|14.4|33.4|||Chan and Zhang|||Additional serotypes - serotype 6A||33.4|14.4|
91579775|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|97.6|||||TWO_SIDED|95.0|91.6|99.7|||Chan and Zhang|||Additional serotypes - serotype 7F||99.7|91.6|
91579776|NCT00688870|183049169|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.5|||Chan and Zhang|||Additional serotypes - serotype 19A||4.5|-4.6|
91579777|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 4||3.1|-6.9|
91579778|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 6B||4.4|-4.6|
91579779|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 9V||3.1|-6.9|
91579780|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 14||4.4|-4.6|
91579781|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 18C||4.4|-4.6|
91579782|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 19F||3.1|-6.9|
91579783|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 23F||4.4|-4.6|
91579784|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.0|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 1||98.6|87.7|
91579785|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|82.5|||||TWO_SIDED|95.0|72.0|90.1|||Chan and Zhang|||Additional serotypes - serotype 3||90.1|72.0|
91579786|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|9.6|||||TWO_SIDED|95.0|3.8|18.1|||Chan and Zhang|||Additional serotypes - serotype 5||18.1|3.8|
91579787|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Additional serotypes - serotype 6A||4.4|-4.6|
91579788|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|93.8|||||TWO_SIDED|95.0|86.0|97.9|||Chan and Zhang|||Additional serotypes - serotype 7F||97.9|86.0|
91579789|NCT00688870|183049170|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.2|||||TWO_SIDED|95.0|-3.4|6.5|||Chan and Zhang|||Additional serotypes - serotype 19A||6.5|-3.4|
91579790|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.62|||||TWO_SIDED|95.0|0.5|0.78|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.78|0.50|
91579791|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.7|1.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.17|0.70|
91579792|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.55|0.82|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||0.82|0.55|
91579793|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.06|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||1.06|0.67|
91579794|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.97|0.63|
91579795|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.6|0.94|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||0.94|0.60|
91579796|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.59|||||TWO_SIDED|95.0|0.46|0.77|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.77|0.46|
91579797|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|202.58|||||TWO_SIDED|95.0|157.04|261.32|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||261.32|157.04|
91579798|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|24.11|||||TWO_SIDED|95.0|18.46|31.49|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||31.49|18.46|
91579799|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.69|||||TWO_SIDED|95.0|4.37|7.41|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||7.41|4.37|
91579800|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.82|||||TWO_SIDED|95.0|4.42|7.67|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||7.67|4.42|
91579801|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|96.1|||||TWO_SIDED|95.0|75.6|122.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||122.17|75.60|
91579802|NCT00688870|183049171|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||1.83|1.23|
91579803|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMC|0.64|||||TWO_SIDED|95.0|0.49|0.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.84|0.49|
91579804|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.03|||||TWO_SIDED|95.0|0.77|1.36|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.36|0.77|
91579805|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||1.05|0.64|
91579806|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.51|0.91|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||0.91|0.51|
91579807|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.99|0.57|
91579808|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.09|||||TWO_SIDED|95.0|0.83|1.43|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||1.43|0.83|
91579809|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.92|0.52|
91579810|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|303.73|||||TWO_SIDED|95.0|213.63|431.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||431.83|213.63|
91579811|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|10.65|||||TWO_SIDED|95.0|7.77|14.62|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||14.62|7.77|
91579812|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.79|||||TWO_SIDED|95.0|3.78|6.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||6.08|3.78|
91579813|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|3.05|||||TWO_SIDED|95.0|2.28|4.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||4.08|2.28|
91579814|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|105.0|||||TWO_SIDED|95.0|75.6|145.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||145.84|75.60|
91579815|NCT00688870|183049172|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.45|||||TWO_SIDED|95.0|3.54|5.6|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||5.60|3.54|
91579816|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.735
91579817|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.533
91579818|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.039
91579819|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.059
91579820|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||>0.99
91579821|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||>0.99
91579822|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
91517213|NCT01972841|182908252|SUPERIORITY||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.24|0.51|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.51|-1.24|<0.001
91579823|NCT00688870|183049173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.275
91579824|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
91579825|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.617
91579826|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.810
91579827|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.810
91579828|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.674||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.674
91579829|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
91579830|NCT00688870|183049174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.497
91579831|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
91579832|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||>0.99
91579833|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.044
91517214|NCT01972841|182908253|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.05||0.006|TWO_SIDED|95.0|0.81|0.96|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.96|0.81|0.006
91517215|NCT01972841|182908253|SUPERIORITY||Rate ratio|0.81|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.74|0.88|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.88|0.74|<0.001
91517216|NCT01972841|182908253|SUPERIORITY||Rate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|0.84|1.0|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.00|0.84|0.049
91517217|NCT01972841|182908253|SUPERIORITY||Rate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|0.79|0.94|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.94|0.79|0.001
91517218|NCT01972841|182908254|SUPERIORITY||Least squares mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.073|TWO_SIDED|95.0|-1.28|0.06|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.06|-1.28|0.073
91579834|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.076
91579835|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.496
91579836|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.361
91579837|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.635||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||0.635
91579838|NCT00688870|183049175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.244
91579839|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.076
91579840|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.735
91579841|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||>0.99
91579842|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.477
91579843|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.805
91579844|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
91579845|NCT00688870|183049176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.477
91579846|NCT00688870|183049177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.633
91579847|NCT00688870|183049177|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
91579848|NCT00688870|183049177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.527
91579849|NCT00688870|183049177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.613||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.613
91579850|NCT00688870|183049177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.753
91579851|NCT00688870|183049177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.748
91579852|NCT00688870|183049178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.327
91579853|NCT00688870|183049178|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
91579854|NCT00688870|183049178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.522
91579855|NCT00688870|183049178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.872
91579856|NCT00688870|183049178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.868
91579857|NCT00688870|183049178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.237
91579858|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.329
91579859|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||0.492
91579860|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Fever \>40 degrees C, Fisher exact test was used to calculate p-value.||||0.496
91579861|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.322
91579862|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.610
91579863|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.726
91579864|NCT00688870|183049179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.855||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.855
91579865|NCT00688870|183049180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.326
91579866|NCT00688870|183049180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
91579867|NCT00688870|183049180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.714
91579868|NCT00688870|183049180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||>0.99
91579869|NCT00688870|183049180|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||>0.99
91579870|NCT00688870|183049180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.525
91579871|NCT03592745|183049193|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|32.0||||0.002|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in bicep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.002
91579872|NCT03592745|183049193|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|87.0||||0.445|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in tricep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.445
91579873|NCT03592745|183049193|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|95.0||||0.678|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in bicep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.678
91579874|NCT03592745|183049193|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|98.0||||0.777|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in tricep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.777
91579875|NCT03592745|183049194|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 3 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|112.0||||1|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||1.000
91579876|NCT03592745|183049194|EQUIVALENCE|Statistical analysis of median change from baseline to week 16 (3 month follow-up) was assessed with the Upper Extremity Fugl Meyer score in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median change in Upper Extremity Fugl Meyer score between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|110.5||||0.95|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.950
91579877|NCT00293059|183049195|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
91579878|NCT04362189|183049267|SUPERIORITY||Slope|-1.93|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579879|NCT04362189|183049268|SUPERIORITY||Slope|-1.31|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|||||
91579880|NCT04362189|183049269|SUPERIORITY||Slope|1.36|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579881|NCT04362189|183049270|SUPERIORITY||Slope|0.23|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579882|NCT04362189|183049271|SUPERIORITY||Slope|-0.15|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579883|NCT04362189|183049272|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED||||||||HB-adMSCs represents Numerator and Placebo represents Denominator.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579884|NCT04362189|183049279|SUPERIORITY||Slope|-0.17|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579885|NCT04362189|183049280|SUPERIORITY||Slope|0.55|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579886|NCT04362189|183049281|SUPERIORITY||Slope|0.26|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579887|NCT04362189|183049282|SUPERIORITY||Slope|0.81|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
91579888|NCT05116540|183049347|SUPERIORITY||Mean Difference (Final Values)|22.121|STANDARD_ERROR_OF_MEAN|4.616||0.0002|TWO_SIDED|95.0|12.282|31.959|||ANCOVA|||||31.959|12.282|0.0002
91579889|NCT05116540|183049348|SUPERIORITY||Mean Difference (Final Values)|15.764|STANDARD_ERROR_OF_MEAN|5.844||0.0166|TWO_SIDED|95.0|3.307|28.221|||ANCOVA|||||28.221|3.307|0.0166
91579890|NCT05116540|183049349|SUPERIORITY||Mean Difference (Final Values)|22.137|STANDARD_DEVIATION|4.962||0.9905|TWO_SIDED|95.0|12.361|32.006|||ANCOVA|||||32.006|12.361|0.9905
91579891|NCT05116540|183049350|SUPERIORITY||Mean Difference (Final Values)|15.747|STANDARD_DEVIATION|6.274||0.8292|TWO_SIDED|95.0|3.329|28.177|||ANCOVA|||||28.177|3.329|0.8292
91579892|NCT05116540|183049351|SUPERIORITY||Mean Difference (Final Values)|-1.554|STANDARD_ERROR_OF_MEAN|0.638||0.0278|TWO_SIDED|95.0|-2.914|-0.195|||ANCOVA|||||-0.195|-2.914|0.0278
91579893|NCT05116540|183049352|SUPERIORITY||Mean Difference (Final Values)|5.453|STANDARD_ERROR_OF_MEAN|2.757||0.0666|TWO_SIDED|95.0|-0.424|11.33|||ANCOVA|||||11.330|-0.424|0.0666
91579894|NCT05116540|183049353|SUPERIORITY||Mean Difference (Final Values)|10.112|STANDARD_ERROR_OF_MEAN|5.508||0.0863|TWO_SIDED|95.0|-1.629|21.853|||ANCOVA|||||21.853|-1.629|0.0863
91579895|NCT05116540|183049354|SUPERIORITY||Mean Difference (Final Values)|0.977|STANDARD_ERROR_OF_MEAN|1.633||0.5588|TWO_SIDED|95.0|-2.504|4.457|||ANCOVA|||||4.457|-2.504|0.5588
91579896|NCT05116540|183049355|SUPERIORITY||Mean Difference (Final Values)|-4.593|STANDARD_ERROR_OF_MEAN|1.023||0.0004|TWO_SIDED|95.0|-6.773|-2.413|||ANCOVA|||||-2.413|-6.773|0.0004
91579897|NCT03809429|183049403|OTHER||Difference|1.31||||0.0185|TWO_SIDED|95.0|0.22|2.4|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.40|0.22|0.0185
91579898|NCT03809429|183049406|OTHER||Difference|1.14||||0.0281|TWO_SIDED|95.0|0.12|2.15|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=10 mm at end of stimulation||2.15|0.12|0.0281
91579899|NCT03809429|183049406|OTHER||Difference|0.99||||0.0258|TWO_SIDED|95.0|0.12|1.86|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=12 mm at end of stimulation||1.86|0.12|0.0258
91579900|NCT03809429|183049406|OTHER||Difference|0.58||||0.0672|TWO_SIDED|95.0|-0.04|1.2|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=15 mm at end of stimulation||1.20|-0.04|0.0672
91579901|NCT03809429|183049406|OTHER||Difference|0.21||||0.339|TWO_SIDED|95.0|-0.22|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=17 mm at end of stimulation||0.63|-0.22|0.3390
91579902|NCT03809429|183049408|OTHER||Difference|1.11||||0.0962|TWO_SIDED|95.0|-0.2|2.41|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.41|-0.20|0.0962
91579903|NCT03809429|183049410|OTHER||Difference|0.51||||0.1894|TWO_SIDED|95.0|-0.25|1.27|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of embryos||1.27|-0.25|0.1894
91579904|NCT03809429|183049410|OTHER||Difference|-0.03||||0.9361|TWO_SIDED|95.0|-0.68|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of Good-quality embryos||0.63|-0.68|0.9361
91579905|NCT03809429|183049411|OTHER||Difference|0.37||||0.2025|TWO_SIDED|95.0|-0.2|0.94|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Total number of blastocysts||0.94|-0.20|0.2025
91579906|NCT03809429|183049411|OTHER||Difference|0.12||||0.5946|TWO_SIDED|95.0|-0.31|0.54|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of good-quality blastocysts||0.54|-0.31|0.5946
91579907|NCT03809429|183049417|OTHER||Difference|16.94|||<|0.0001|TWO_SIDED|95.0|12.13|21.74|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||21.74|12.13|<0.0001
91579908|NCT03809429|183049418|OTHER||Difference|1.56|||<|0.0001|TWO_SIDED|95.0|1.19|1.92|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||1.92|1.19|<0.0001
91579909|NCT03809429|183049419|OTHER||Difference|6.99||||0.1579|TWO_SIDED|95.0|-2.71|16.7|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.70|-2.71|0.1579
91579910|NCT03809429|183049421|OTHER||Difference|7.66||||0.1134|TWO_SIDED|95.0|-1.82|17.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||17.14|-1.82|0.1134
91579911|NCT03809429|183049422|OTHER||Difference|8.81||||0.0642|TWO_SIDED|95.0|-0.52|18.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||18.14|-0.52|0.0642
91579912|NCT03809429|183049423|OTHER||Difference|7.74||||0.1002|TWO_SIDED|95.0|-1.49|16.97|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.97|-1.49|0.1002
91579913|NCT02245737|183049430|SUPERIORITY||LS Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.77||0.232|TWO_SIDED|95.0|-2.447|0.594|||Mixed Models Analysis|||||0.594|-2.447|0.232
91579914|NCT02245737|183049430|SUPERIORITY||LS Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.78||0.599|TWO_SIDED|95.0|-1.124|1.947|||Mixed Models Analysis|||||1.947|-1.124|0.599
91579915|NCT02245737|183049431|SUPERIORITY||LS Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.83||0.971|TWO_SIDED|95.0|-1.609|1.669|||Mixed Models Analysis|||||1.669|-1.609|0.971
91579916|NCT02245737|183049431|SUPERIORITY||LS Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.923|TWO_SIDED|95.0|-1.58|1.743|||Mixed Models Analysis|||||1.743|-1.580|0.923
91579917|NCT02245737|183049432|SUPERIORITY||LS Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.53||0.796|TWO_SIDED|95.0|-1.172|0.899|||Mixed Models Analysis|||||0.899|-1.172|0.796
91579918|NCT02245737|183049432|SUPERIORITY||LS Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.53||0.252|TWO_SIDED|95.0|-0.437|1.66|||Mixed Models Analysis|||||1.660|-0.437|0.252
91579919|NCT02245737|183049433|SUPERIORITY||LS Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|1.4||0.428|TWO_SIDED|95.0|-1.637|3.852|||Mixed Models Analysis|||||3.852|-1.637|0.428
91579920|NCT02245737|183049433|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.42||0.926|TWO_SIDED|95.0|-2.918|2.655|||Mixed Models Analysis|||||2.655|-2.918|0.926
91579921|NCT02245737|183049434|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.533|TWO_SIDED|95.0|-0.322|0.622|||Mixed Models Analysis|||||0.622|-0.322|0.533
91579922|NCT02245737|183049434|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|-0.328|0.63|||Mixed Models Analysis|||||0.630|-0.328|0.537
91579923|NCT02245737|183049436|SUPERIORITY||LS Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|1.13||0.116|TWO_SIDED|95.0|-0.441|3.986|||Mixed Models Analysis|||||3.986|-0.441|0.116
91579924|NCT02245737|183049436|SUPERIORITY||LS Mean Difference (Final Values)|1.45|STANDARD_ERROR_OF_MEAN|1.15||0.208|TWO_SIDED|95.0|-0.808|3.704|||Mixed Models Analysis|||||3.704|-0.808|0.208
91579925|NCT02245737|183049437|SUPERIORITY||LS Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.36||0.379|TWO_SIDED|95.0|-0.391|1.027|||Mixed Models Analysis|||||1.027|-0.391|0.379
91579926|NCT02245737|183049437|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.992|TWO_SIDED|95.0|-0.714|0.721|||Mixed Models Analysis|||||0.721|-0.714|0.992
91579927|NCT02245737|183049438|SUPERIORITY||LS Mean Difference (Final Values)|-51.27|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-56.963|-45.578|||ANCOVA|||||-45.578|-56.963|<0.001
91579928|NCT02245737|183049438|SUPERIORITY||LS Mean Difference (Final Values)|-65.48|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-70.947|-60.022|||ANCOVA|||||-60.022|-70.947|<0.001
91579929|NCT02245737|183049439|SUPERIORITY||LS Mean Difference (Final Values)|-57.99|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-62.865|-53.108|||ANCOVA|||||-53.108|-62.865|<0.001
91579930|NCT02245737|183049439|SUPERIORITY||LS Mean Difference (Final Values)|-73.25|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-77.926|-68.575|||ANCOVA|||||-68.575|-77.926|<0.001
91579931|NCT02245737|183049440|SUPERIORITY||LS Mean Difference (Final Values)|-19.87|STANDARD_ERROR_OF_MEAN|11.33||0.081|TWO_SIDED|95.0|-42.21|2.464|||ANCOVA|||||2.464|-42.210|0.081
91579932|NCT02245737|183049440|SUPERIORITY||LS Mean Difference (Final Values)|-15.31|STANDARD_ERROR_OF_MEAN|10.78||0.157|TWO_SIDED|95.0|-36.555|5.938|||ANCOVA|||||5.938|-36.555|0.157
91579933|NCT02245737|183049441|SUPERIORITY||LS Mean Difference (Final Values)|-2.62|STANDARD_ERROR_OF_MEAN|1.33||0.05|TWO_SIDED|95.0|-5.243|-0.002|||ANCOVA|||||-0.002|-5.243|0.050
91579934|NCT02245737|183049441|SUPERIORITY||LS Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|1.27||0.095|TWO_SIDED|95.0|-4.618|0.373|||ANCOVA|||||0.373|-4.618|0.095
91579935|NCT02245737|183049442|SUPERIORITY||LS Mean Difference (Final Values)|-13.68|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.785|-8.574|||ANCOVA|||||-8.574|-18.785|<0.001
91579936|NCT02245737|183049442|SUPERIORITY||LS Mean Difference (Final Values)|-17.66|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-22.887|-12.428|||ANCOVA|||||-12.428|-22.887|<0.001
91579937|NCT02245737|183049443|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.426|TWO_SIDED|95.0|-0.033|0.014|||ANCOVA|||||0.014|-0.033|0.426
91579938|NCT02245737|183049443|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.66|TWO_SIDED|95.0|-0.029|0.018|||ANCOVA|||||0.018|-0.029|0.660
91579939|NCT02245737|183049444|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.21|TWO_SIDED|95.0|-0.015|0.003|||ANCOVA|||||0.003|-0.015|0.210
91579940|NCT02245737|183049444|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.568|TWO_SIDED|95.0|-0.013|0.007|||ANCOVA|||||0.007|-0.013|0.568
91579941|NCT02245737|183049445|SUPERIORITY||LS Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.258|-1.413|||ANCOVA|||||-1.413|-3.258|<0.001
91579942|NCT02245737|183049445|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-4.118|-2.247|||ANCOVA|||||-2.247|-4.118|<0.001
91579943|NCT02929329|183049469|SUPERIORITY|"The overall type I error was 0.05 for 2-sided testing across primary and secondary outcomes.~Control for multiple comparisons was achieved using the following testing algorithm: if the primary outcome met the P-value threshold of 0.05, the alpha error would be divided unequally between cardiovascular death (96% of the overall alpha error, or 0.048) and change from baseline to week 24 in the Kansas City Cardiomyopathy Questionnaire total symptom score (4% of the overall alpha error, or 0.002)."|Hazard Ratio (HR)|0.92||||0.0252|TWO_SIDED|95.0|0.86|0.99|||Regression, Cox|Stratified by randomization setting and region, including terms for baseline estimated glomerular filtration rate (eGFR) and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||0.99|0.86|0.0252
91579944|NCT02929329|183049469|SUPERIORITY|||||||0.0211|||||||Stratified log-rank test|Log-rank test stratified by randomization setting and region.||||||0.0211
91579945|NCT02929329|183049469|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.86|0.99|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||0.99|0.86|
91579946|NCT02929329|183049470|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8555|TWO_SIDED|95.0|0.92|1.11||If significance for the primary outcome was determined, cardiovascular death was tested against an alpha of 0.048.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||1.11|0.92|0.8555
91579947|NCT02929329|183049470|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.11|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||1.11|0.92|
91579948|NCT02929329|183049471|OTHER||Least Squares (LS) Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.4|0.48|||||Treatment difference = Omecamtiv mecarbil - Placebo|||0.48|-1.40|
91579949|NCT02929329|183049471|OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|0.54|4.46|||||Treatment difference = Omecamtiv mecarbil - Placebo|||4.46|0.54|
91579950|NCT02929329|183049471|SUPERIORITY|If significance for the primary outcome was determined, change from baseline in the KCCQ total symptom score was tested against an alpha of 0.002.||||||0.0278|||||||Omnibus F-test|||||||0.0278
91579951|NCT02929329|183049471|OTHER||Pooled treatment difference|0.75|||||TWO_SIDED|95.0|-2.55|4.51|||||Overall pooled estimate of treatment difference (Omecamtiv mecarbil - Placebo) using random effects meta-analysis approach.|||4.51|-2.55|
91579952|NCT02929329|183049471|SUPERIORITY||LS Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.62|0.2|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||0.20|-1.62|
91579953|NCT02929329|183049471|SUPERIORITY||LS mean difference|2.31|||||TWO_SIDED|95.0|0.8|3.82|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||3.82|0.80|
91579954|NCT02929329|183049472|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.1902|TWO_SIDED|95.0|0.87|1.03||If statistical significance was achieved for both the time to CV death and change from baseline in the KCCQ TSS, time to first heart failure hospitalization was to be tested at the full alpha.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.03|0.87|0.1902
91579955|NCT02929329|183049472|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.04|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint are considered as the competing risk.||1.04|0.88|
91579956|NCT02929329|183049473|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9633|TWO_SIDED|95.0|0.92|1.09||If time to first heart failure hospitalization was statistically significant, time to all-cause death was to be tested with the same alpha as time to first heart failure hospitalization.|Regression, Cox||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.09|0.92|0.9633
91579957|NCT01639560|183049522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|2.5|18.1|||Regression, Logistic|||||18.1|2.5|<0.001
91579958|NCT01639560|183049523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.001|TWO_SIDED|95.0|2.2|24.0|||Regression, Logistic|||||24.0|2.2|0.001
91579959|NCT01639560|183049524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.047|TWO_SIDED|95.0|1.0|6.3|||Regression, Logistic|||||6.3|1.0|0.047
91579960|NCT01639560|183049525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.009|TWO_SIDED|95.0|1.5|16.5|||Regression, Logistic|||||16.5|1.5|0.009
91579961|NCT00774930|183049543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||ANCOVA|This analysis does not include any imputation for the early roll over subjects||||||0.0165
91579962|NCT00774930|183049544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2544|||||||ANCOVA|ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening||||||0.2544
91579963|NCT03292432|183049593|SUPERIORITY||Risk Difference (RD)|-3.5||||0.8|TWO_SIDED|95.0|-21.8|15.2|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 50 copies/mL in TERA arm minus SOC arm|||15.2|-21.8|0.80
91579964|NCT03292432|183049594|SUPERIORITY||Risk Difference (RD)|-0.7|||>|0.99|TWO_SIDED|95.0|-20.9|19.6|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/ml in TERA arm minus SOC arm|||19.6|-20.9|>0.99
91579965|NCT03292432|183049595|SUPERIORITY||Risk Difference (RD)|-13.1||||0.24|TWO_SIDED|95.0|-32.1|7.2|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.2|-32.1|0.24
91579966|NCT03292432|183049595|SUPERIORITY||Risk Difference (RD)|3.8||||0.76|TWO_SIDED|95.0|-16.0|22.6|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||22.6|-16.0|0.76
91579967|NCT03292432|183049595|SUPERIORITY||Risk Difference (RD)|3.6|||>|0.99|TWO_SIDED|95.0|-21.8|27.4|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||27.4|-21.8|>0.99
91579968|NCT03292432|183049596|SUPERIORITY||Risk Difference (RD)|-13.0||||0.26|TWO_SIDED|95.0|-32.7|7.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.3|-32.7|0.26
91579969|NCT03292432|183049596|SUPERIORITY||Risk Difference (RD)|11.5||||0.42|TWO_SIDED|95.0|-11.2|32.8|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||32.8|-11.2|0.42
91579970|NCT03292432|183049596|SUPERIORITY||Risk Difference (RD)|-4.4||||0.77|TWO_SIDED|95.0|-29.5|20.7|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||20.7|-29.5|0.77
91579971|NCT03292432|183049597|SUPERIORITY||Risk Difference (RD)|5.8||||0.67|TWO_SIDED|95.0|-14.6|25.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 12 and maintained to Week 48 in TERA arm minus SOC arm|||25.3|-14.6|0.67
91579972|NCT03292432|183049598|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken from Weeks 0 -12||||<0.001
91579973|NCT03292432|183049598|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>12 to 24||||<0.001
91579974|NCT03292432|183049598|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>24 to 36||||0.06
91579975|NCT03292432|183049598|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>36 to 48||||0.50
91579976|NCT03292432|183049599|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks 0 - 12||||<0.001
91579977|NCT03292432|183049599|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks \>12 - 24||||<0.001
91579978|NCT03292432|183049599|SUPERIORITY|||||||0.05||||||p-value equal to a priori threshold for statistical significance|Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken on time from Weeks \>24 - 36||||0.05
91579979|NCT03292432|183049599|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of doses taken on time from Weeks \>36 - 48||||0.49
91579980|NCT03292432|183049600|SUPERIORITY||Risk Ratio (RR)|2.51|||<|0.001|TWO_SIDED|95.0|1.9|3.33|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks 0 - 12||3.33|1.90|<0.001
91579981|NCT03292432|183049600|SUPERIORITY||Risk Ratio (RR)|1.56|||<|0.001|TWO_SIDED|95.0|1.29|1.89|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>12 - 24||1.89|1.29|<0.001
91579982|NCT03292432|183049600|SUPERIORITY||Risk Ratio (RR)|1.23||||0.02|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|P-value from Pearson Chi-square test from generalized linear model with Poisson link|Comparison of incidence rates from Weeks \>24 - 36||1.47|1.03|0.020
91579983|NCT03292432|183049600|SUPERIORITY||Risk Ratio (RR)|1.08||||0.39|TWO_SIDED|95.0|0.9|1.3|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>36 - 48||1.30|0.90|0.39
91579984|NCT03292432|183049601|SUPERIORITY||Risk Difference (RD)|2.3|||>|0.99|TWO_SIDED|95.0|-16.4|21.1|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/mL in TERA arm minus SOC arm|||21.1|-16.4|>0.99
91579985|NCT03292432|183049602|SUPERIORITY||Risk Difference (RD)|4.7||||0.71|TWO_SIDED|95.0|-9.0|19.4|||Fisher Exact||Risk difference reflects percentage of participants achieving sustained virologic control in TERA arm minus SOC arm|||19.4|-9.0|0.71
91579986|NCT00911937|183049604|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.37|-0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.08|-0.37|0.0030
91579987|NCT00911937|183049605|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0772|TWO_SIDED|95.0|-0.27|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.27|0.0772
91579988|NCT00911937|183049606|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
91579989|NCT00911937|183049608|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0827|TWO_SIDED|95.0|-0.25|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.25|0.0827
91579990|NCT00911937|183049608|SUPERIORITY_OR_OTHER||Least Squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0112|TWO_SIDED|95.0|-0.33|-0.04||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.04|-0.33|0.0112
91579991|NCT00911937|183049609|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0023
91579992|NCT00911937|183049611|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.15||0.0026|TWO_SIDED|95.0|-0.74|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-0.74|0.0026
91579993|NCT00911937|183049611|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0014|TWO_SIDED|95.0|-0.9|-0.22||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.22|-0.90|0.0014
91579994|NCT00911937|183049612|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0016
91579995|NCT00911937|183049612|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0004
91579996|NCT00911937|183049614|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0072|TWO_SIDED|95.0|-1.03|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-1.03|0.0072
91579997|NCT00911937|183049614|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED|95.0|-1.25|-0.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.32|-1.25|0.0009
91579998|NCT00911937|183049615|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0041
91579999|NCT00911937|183049615|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
91580000|NCT00911937|183049617|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.3954|TWO_SIDED|95.0|-0.47|0.19||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.19|-0.47|0.3954
91580001|NCT00911937|183049617|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.2166|TWO_SIDED|95.0|-0.48|0.11||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.11|-0.48|0.2166
91580002|NCT00911937|183049620|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.1018|TWO_SIDED|95.0|-0.85|0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.08|-0.85|0.1018
91580003|NCT00911937|183049620|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0027|TWO_SIDED|95.0|-1.2|-0.25||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.25|-1.20|0.0027
91580004|NCT00911937|183049622|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.63||0.0131|TWO_SIDED|95.0|-2.79|-0.33||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.33|-2.79|0.0131
91580005|NCT00911937|183049622|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.43|STANDARD_ERROR_OF_MEAN|0.69||0.0004|TWO_SIDED|95.0|-3.78|-1.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.08|-3.78|0.0004
91580006|NCT00911937|183049624|SUPERIORITY_OR_OTHER||Least squares mean difference|1.32|STANDARD_ERROR_OF_MEAN|7.2||0.8547|TWO_SIDED|95.0|-12.82|15.46||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||15.46|-12.82|0.8547
91580007|NCT00911937|183049626|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.22||0.8396|TWO_SIDED|95.0|-9.14|7.44||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.44|-9.14|0.8396
91580008|NCT00911937|183049628|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.37|STANDARD_ERROR_OF_MEAN|1.26||0.0006|TWO_SIDED|95.0|-6.84|-1.89||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.89|-6.84|0.0006
91580009|NCT00911937|183049630|SUPERIORITY_OR_OTHER||Least squares mean difference|3.42|STANDARD_ERROR_OF_MEAN|1.34||0.011|TWO_SIDED|95.0|0.79|6.05||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.05|0.79|0.0110
91580010|NCT00911937|183049630|SUPERIORITY_OR_OTHER||Least squares mean difference|3.14|STANDARD_ERROR_OF_MEAN|1.35||0.02|TWO_SIDED|95.0|0.5|5.79||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.79|0.50|0.0200
91580011|NCT00911937|183049630|SUPERIORITY_OR_OTHER||Least squares mean difference|3.48|STANDARD_ERROR_OF_MEAN|1.51||0.0218|TWO_SIDED|95.0|0.51|6.45||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.45|0.51|0.0218
91580012|NCT00911937|183049630|SUPERIORITY_OR_OTHER||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.93||0.0458|TWO_SIDED|95.0|0.03|3.68||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||3.68|0.03|0.0458
91580013|NCT00911937|183049630|SUPERIORITY_OR_OTHER||Least squares mean difference|3.02|STANDARD_ERROR_OF_MEAN|1.17||0.01|TWO_SIDED|95.0|0.72|5.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.32|0.72|0.0100
91580014|NCT01498679|183049631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|51.0|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||ANCOVA|||||59.7|42.2|<0.001
91580015|NCT00355199|183049655|SUPERIORITY||Hazard Ratio (HR)|0.99|||<|0.05|TWO_SIDED|95.0|0.66|1.48|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.48|0.66|<0.05
91580016|NCT00355199|183049657|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.05|TWO_SIDED|95.0|0.29|1.21|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.21|0.29|<0.05
91580017|NCT00355199|183049658|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.57|1.52|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.52|0.57|<0.05
91580018|NCT02071290|183049663|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
91580019|NCT02071290|183049664|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|||||||0.287
91580020|NCT02071290|183049665|SUPERIORITY|||||||0.597|||||||Mixed Models Analysis|||||||0.597
91580021|NCT02071290|183049666|SUPERIORITY|||||||0.307|||||||Mixed Models Analysis|||||||0.307
91580022|NCT02071290|183049667|SUPERIORITY|||||||0.646|||||||Mixed Models Analysis|||||||0.646
91580023|NCT02071290|183049668|SUPERIORITY|||||||0.757|||||||Mixed Models Analysis|||||||0.757
91580024|NCT02071290|183049669|SUPERIORITY|||||||0.075|||||||Mixed Models Analysis|||||||0.075
91580025|NCT02071290|183049670|SUPERIORITY|||||||0.967|||||||Mixed Models Analysis|||||||0.967
91580026|NCT02071290|183049671|SUPERIORITY|||||||0.637|||||||Mixed Models Analysis|||||||0.637
91580027|NCT02071290|183049672|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.664
91580028|NCT02071290|183049673|SUPERIORITY|||||||0.661|||||||Mixed Models Analysis|||||||0.661
91580029|NCT02071290|183049674|SUPERIORITY|||||||0.916|||||||Mixed Models Analysis|||||||0.916
91580030|NCT02071290|183049675|SUPERIORITY|||||||0.437|||||||Mixed Models Analysis|||||||0.437
91580031|NCT02071290|183049676|SUPERIORITY|||||||0.353|||||||Mixed Models Analysis|||||||0.353
91580032|NCT02071290|183049677|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||0.99
91580033|NCT02071290|183049678|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
91580034|NCT02071290|183049679|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||||||0.371
91580035|NCT02071290|183049680|SUPERIORITY|||||||0.106|||||||Mixed Models Analysis|||||||0.106
91580036|NCT02071290|183049681|SUPERIORITY|||||||0.829|||||||Mixed Models Analysis|||||||0.829
91580037|NCT02071290|183049682|SUPERIORITY|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
91580038|NCT02071290|183049683|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
91580039|NCT02071290|183049684|SUPERIORITY|||||||0.151|||||||Wilcoxon (Mann-Whitney)|||||||0.151
91580040|NCT02071290|183049685|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.510
91580041|NCT02071290|183049686|SUPERIORITY|||||||0.348|||||||Chi-squared|||||||0.348
91580042|NCT02071290|183049687|SUPERIORITY|||||||0.911|||||||Chi-squared|||||||0.911
91580043|NCT05126563|183049692|SUPERIORITY||LS Means|0.054|STANDARD_ERROR_OF_MEAN|0.738||0.9416|TWO_SIDED|95.0|-1.42|1.53|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Extreme fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.53|-1.42|0.9416
91580044|NCT05126563|183049693|SUPERIORITY||LS Means|-0.172|STANDARD_ERROR_OF_MEAN|0.685||0.8021|TWO_SIDED|95.0|-1.54|1.2|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.20|-1.54|0.8021
91580045|NCT05126563|183049694|SUPERIORITY||LS Means|0.399|STANDARD_ERROR_OF_MEAN|0.515||0.4417|TWO_SIDED|95.0|-0.63|1.43|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms. - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.43|-0.63|0.4417
91580046|NCT05126563|183049695|SUPERIORITY||Slope|0.542|STANDARD_ERROR_OF_MEAN|0.721||0.455|TWO_SIDED|95.0|-0.9|1.98|||ANCOVA|||The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.98|-0.90|0.4550
91580047|NCT05126563|183049696|SUPERIORITY||LS Means|-0.047|STANDARD_ERROR_OF_MEAN|0.466||0.92|TWO_SIDED|95.0|-0.98|0.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.89|-0.98|0.9200
91580048|NCT05126563|183049697|SUPERIORITY||LS Means|-0.16|STANDARD_ERROR_OF_MEAN|0.36||0.6589|TWO_SIDED|95.0|-0.88|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-0.88|0.6589
91580049|NCT05126563|183049698|SUPERIORITY||LS Means|0.162|STANDARD_ERROR_OF_MEAN|0.725||0.824|TWO_SIDED|95.0|-1.29|1.61|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms Extreme Fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.61|-1.29|0.8240
91580050|NCT05126563|183049699|SUPERIORITY||LS Means|-0.009|STANDARD_ERROR_OF_MEAN|0.686||0.9892|TWO_SIDED|95.0|-1.38|1.36|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain Fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.36|-1.38|0.9892
91580051|NCT05126563|183049700|SUPERIORITY||LS Means|0.439|STANDARD_ERROR_OF_MEAN|0.513||0.3952|TWO_SIDED|95.0|-0.59|1.47|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.47|-0.59|0.3952
91580052|NCT05126563|183049701|SUPERIORITY||LS Means|0.535|STANDARD_ERROR_OF_MEAN|0.704||0.4504|TWO_SIDED|95.0|-0.87|1.94|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep Disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.87|0.4504
91580053|NCT05126563|183049702|SUPERIORITY||LS Means|-0.161|STANDARD_ERROR_OF_MEAN|0.469||0.7318|TWO_SIDED|95.0|-1.1|0.78|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.78|-1.10|0.7318
91580054|NCT05126563|183049703|SUPERIORITY||LS Means|-0.215|STANDARD_ERROR_OF_MEAN|0.357||0.5485|TWO_SIDED|95.0|-0.93|0.5|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Smell scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.50|-0.93|0.5485
91580055|NCT05126563|183049734|SUPERIORITY||LS Means|-0.377|STANDARD_ERROR_OF_MEAN|0.407||0.3577|TWO_SIDED|95.0|-1.19|0.44|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at rest scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.44|-1.19|0.3577
91580056|NCT05126563|183049735|SUPERIORITY||LS Means|-0.203|STANDARD_ERROR_OF_MEAN|0.563||0.7196|TWO_SIDED|95.0|-1.33|0.92|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea during activity scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.92|-1.33|0.7196
91580057|NCT05126563|183049736|SUPERIORITY||LS Means|-0.306|STANDARD_ERROR_OF_MEAN|0.435||0.4847|TWO_SIDED|95.0|-1.18|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Cough scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-1.18|0.4847
91580058|NCT05126563|183049737|SUPERIORITY||LS Means|0.619|STANDARD_ERROR_OF_MEAN|0.661||0.3535|TWO_SIDED|95.0|-0.71|1.94|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Body aches scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.71|0.3535
91580059|NCT05126563|183049738|SUPERIORITY||LS Means|0.472|STANDARD_ERROR_OF_MEAN|0.655||0.4746|TWO_SIDED|95.0|-0.84|1.78|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.78|-0.84|0.4746
91580060|NCT05126563|183049739|SUPERIORITY||LS Means|-1.433|STANDARD_ERROR_OF_MEAN|2.141||0.5059|TWO_SIDED|95.0|-5.72|2.85|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Subject's energy - Fatigue Assessment form scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.85|-5.72|0.5059
91580061|NCT05126563|183049740|SUPERIORITY||LS Means|-6.095|STANDARD_ERROR_OF_MEAN|4.99||0.2269|TWO_SIDED|95.0|-16.08|3.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups.|The null hypothesis is that the difference in change from baseline to Weeks 26 in Short Form 36 Health Survey Questionnaire (General Health) between treatment groups (HB-adMSCs - Placebo) is equal to zero.||3.89|-16.08|0.2269
91580062|NCT05126563|183049741|SUPERIORITY||LS Means|-0.122|STANDARD_ERROR_OF_MEAN|1.392||0.8735|TWO_SIDED|95.0|-2.91|2.66|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.66|-2.91|0.8735
91580063|NCT05126563|183049742|SUPERIORITY||LS Means|-3.424|STANDARD_ERROR_OF_MEAN|4.82||0.4802|TWO_SIDED|95.0|-13.07|6.22|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||6.22|-13.07|0.4802
91580064|NCT06612255|183049743|OTHER|Ratio (%) of adjusted geometric means with comparison presented as test (powder)/reference (tablet).|Fixed Effect Analysis|51.68|||||TWO_SIDED|90.0|45.71|58.43||||||Results obtained from mixed effects model of natural log transformed pharmacokinetic parameters including terms for regimen, period and sequence fitted as fixed effects and subject nested within sequence fitted as a random effect.||58.43|45.71|
91580065|NCT00964886|183049749|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANCOVA|||In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).||||0.7
91580066|NCT00964886|183049750|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|Means are adjusted for baseline Roland and Morris scores.||In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.||||0.84
91580067|NCT00964886|183049751|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
91580068|NCT00964886|183049752|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)||||0.8
91580069|NCT01871805|183049764|SUPERIORITY|||||||0.0056||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0056
91580070|NCT01871805|183049765|SUPERIORITY|||||||0.0251||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0251
91580071|NCT01871805|183049765|SUPERIORITY|||||||0.0203||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0203
91580072|NCT01871805|183049767|SUPERIORITY|||||||0.001||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0010
91580073|NCT03535597|183049818|OTHER||Risk Ratio (RR)|0.99||||0.906|TWO_SIDED|95.0|0.89|1.11|||Chi-squared|||||1.11|0.89|0.906
91580074|NCT03535597|183049818|OTHER||Risk Ratio (RR)|1.27||||0.002|TWO_SIDED|95.0|1.09|1.53|||Chi-squared|||||1.53|1.09|0.002
91580075|NCT03535597|183049818|OTHER||Risk Ratio (RR)|0.97||||0.613|TWO_SIDED|95.0|0.86|1.09|||Chi-squared|||||1.09|0.86|0.613
91580076|NCT03535597|183049819|OTHER||Mean Difference (Net)|-98.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
91580077|NCT03535597|183049819|OTHER||Mean Difference (Net)|-120.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
91580078|NCT03535597|183049819|OTHER||Mean Difference (Net)|-94.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
91580079|NCT03535597|183049820|OTHER||Risk Ratio (RR)|0.77||||0.744|TWO_SIDED|95.0|0.23|2.57|||Fisher Exact|||||2.57|0.23|0.744
91580080|NCT03535597|183049820|OTHER||Risk Ratio (RR)|1.02|||>|0.999|TWO_SIDED|95.0|0.31|3.41|||Fisher Exact|||||3.41|0.31|>0.999
91580081|NCT03535597|183049820|OTHER||Risk Ratio (RR)|0.67||||0.724|TWO_SIDED|95.0|0.18|2.46|||Fisher Exact|||||2.46|0.18|0.724
91580082|NCT03535597|183049821|OTHER||Risk Ratio (RR)|1.44||||0.594|TWO_SIDED|95.0|0.56|3.76|||Fisher Exact|||||3.76|0.56|0.594
91580083|NCT03535597|183049821|OTHER||Risk Ratio (RR)|1.1|||>|0.999|TWO_SIDED|95.0|0.37|3.26|||Fisher Exact|||||3.26|0.37|>0.999
91580084|NCT03535597|183049821|OTHER||Risk Ratio (RR)|1.45||||0.581|TWO_SIDED|95.0|0.55|3.88|||Fisher Exact|||||3.88|0.55|0.581
91580085|NCT03535597|183049822|OTHER||Risk Ratio (RR)|1.92||||0.284|TWO_SIDED|95.0|0.71|5.22|||Fisher Exact|||||5.22|0.71|0.284
91580086|NCT03535597|183049822|OTHER||Risk Ratio (RR)|2.1||||0.243|TWO_SIDED|95.0|0.75|5.9|||Fisher Exact|||||5.9|0.75|0.243
91580087|NCT03535597|183049822|OTHER||Risk Ratio (RR)|2.01||||0.266|TWO_SIDED|95.0|0.74|5.54|||Fisher Exact|||||5.54|0.74|0.266
91580088|NCT03484273|183049823|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated Measures ANOVA||Repeated Measured ANOVA was used to compare the 4 compression garment configurations.||||<0.001
91580089|NCT03484273|183049824|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
91580090|NCT03484273|183049825|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
91580091|NCT03484273|183049826|SUPERIORITY|||||||0.01|||||||Repeated Measures ANOVA|||||||0.01
91580092|NCT03484273|183049827|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
91580093|NCT03484273|183049828|SUPERIORITY|||||||0.001|||||||Repeated Measures ANOVA|||||||0.001
91580094|NCT03484273|183049829|SUPERIORITY|||||||0.04|||||||Repeated Measures ANOVA|||||||0.04
91580095|NCT03097484|183049831|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
91580096|NCT03097484|183049832|SUPERIORITY|||||||0.05||||||0.05 is the calculated p-value (not the threshold for statistical significance)|t-test, 2 sided|||||||0.05
91580097|NCT00468104|183049834|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.||||<0.001
91580098|NCT00294515|183049844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<=|0.0002|TWO_SIDED|95.0|0.25|0.66|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.66|0.25|<=0.0002
91580099|NCT00294515|183049845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2|||<|0.0001||95.0|0.11|0.37|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.37|0.11|<0.0001
91580100|NCT00294515|183049846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0001||95.0|0.22|0.6|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.60|0.22|0.0001
91580101|NCT00294515|183049847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0126||95.0|0.35|0.88|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.88|0.35|0.0126
91580102|NCT00294515|183049848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.01||95.0|0.34|0.86|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.86|0.34|0.0100
91580103|NCT01670760|183049880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69||||0.69|TWO_SIDED||||||ANOVA|||||||0.69
91580104|NCT00291642|183049905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.61|-2.09|||ANCOVA|||||-2.09|-4.61|<0.001
91580105|NCT00291642|183049905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||ANCOVA|||||-2.00|-4.50|<0.001
91580106|NCT00291642|183049905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-5.38|-2.88|||ANCOVA|||||-2.88|-5.38|<0.001
91580107|NCT00291642|183049905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.99|-2.49|||ANCOVA|||||-2.49|-4.99|<0.001
91580108|NCT01472549|183049940|SUPERIORITY||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.34|0.9|||Chi-squared|||||0.90|0.34|0.02
91580109|NCT01472549|183049941|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
91580110|NCT01472549|183049942|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.43|1.37|||Chi-squared|||||1.37|0.43|0.37
91580111|NCT01472549|183049943|SUPERIORITY||Risk Ratio (RR)|0.73||||0.49|TWO_SIDED|95.0|0.3|1.8|||Chi-squared|||||1.80|0.30|0.49
91580112|NCT01472549|183049944|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
91580113|NCT01472549|183049945|SUPERIORITY||Risk Ratio (RR)|2.02||||0.56|TWO_SIDED|95.0|0.18|22.11|||Fisher Exact|||||22.11|0.18|0.56
91580114|NCT04602221|183049979|OTHER||Difference of adjusted means|-0.339|STANDARD_ERROR_OF_MEAN|3.8242||0.9296|TWO_SIDED|95.0|-7.975|7.297|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||7.297|-7.975|0.9296
91580115|NCT04602221|183049979|OTHER||Difference of adjusted means|4.002|STANDARD_ERROR_OF_MEAN|3.8224||0.299|TWO_SIDED|95.0|-3.631|11.634|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||11.634|-3.631|0.2990
91580116|NCT04602221|183049979|OTHER||Difference of adjusted means|-1.258|STANDARD_ERROR_OF_MEAN|3.6608||0.7322|TWO_SIDED|95.0|-8.565|6.05|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||6.050|-8.565|0.7322
91580117|NCT04602221|183049980|OTHER||Difference of adjusted means|0.347|STANDARD_ERROR_OF_MEAN|1.563||0.8249|TWO_SIDED|95.0|-2.776|3.471|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||3.471|-2.776|0.8249
91580118|NCT04602221|183049980|OTHER||Difference of adjusted means|-1.085|STANDARD_ERROR_OF_MEAN|1.5889||0.4973|TWO_SIDED|95.0|-4.26|2.091|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||2.091|-4.260|0.4973
91580119|NCT04602221|183049980|OTHER||Difference of adjusted means|-2.858|STANDARD_ERROR_OF_MEAN|1.5266||0.0658|TWO_SIDED|95.0|-5.909|0.192|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.192|-5.909|0.0658
91580120|NCT04602221|183049981|OTHER||Difference of adjusted means|0.0053|STANDARD_ERROR_OF_MEAN|0.00798||0.5081|TWO_SIDED|95.0|-0.0106|0.0213|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0213|-0.0106|0.5081
91580121|NCT04602221|183049981|OTHER||Difference of adjusted means|0.0058|STANDARD_ERROR_OF_MEAN|0.00798||0.4723|TWO_SIDED|95.0|-0.0102|0.0217|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0217|-0.0102|0.4723
91580122|NCT04602221|183049981|OTHER||Difference of adjusted means|0.0333|STANDARD_ERROR_OF_MEAN|0.00767|<|0.0001|TWO_SIDED|95.0|0.018|0.0486|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0486|0.0180|< .0001
91580123|NCT02327351|183049982|SUPERIORITY||survival distribution function|86.0||||0.95|TWO_SIDED|95.0|79.0|94.0|||Gray test|||||94|79|0.95
91580124|NCT02327351|183049988|SUPERIORITY|||||||0.35|||||||Log Rank|||||||0.35
91580125|NCT03001076|183049989|SUPERIORITY||Difference in LS mean|-28.45|STANDARD_ERROR_OF_MEAN|3.022|<|0.001|TWO_SIDED|95.0|-34.376|-22.531|||ANCOVA|||||-22.531|-34.376|<0.001
91580126|NCT03001076|183049990|SUPERIORITY||Difference in LS mean|-23.56|STANDARD_ERROR_OF_MEAN|2.777|<|0.001|TWO_SIDED|95.0|-29.005|-18.121|||ANCOVA|||||-18.121|-29.005|<0.001
91580127|NCT03001076|183049991|SUPERIORITY||Difference in LS mean|-17.99|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-21.94|-14.03|||ANCOVA|||||-14.030|-21.940|<0.001
91580128|NCT03001076|183049992|SUPERIORITY||Difference in LS mean|-19.32|STANDARD_ERROR_OF_MEAN|2.341|<|0.001|TWO_SIDED|95.0|-23.908|-14.732|||ANCOVA|||||-14.732|-23.908|<0.001
91580129|NCT03001076|183049993|SUPERIORITY||Location shift|-31.045|||<|0.001|TWO_SIDED|95.0|-44.761|-17.401|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-17.401|-44.761|<0.001
91580130|NCT03001076|183049994|SUPERIORITY||Difference in LS mean|-4.53|STANDARD_ERROR_OF_MEAN|5.24|=|0.388|TWO_SIDED|95.0|-14.877|5.812|||ANCOVA|||||5.812|-14.877|=0.388
91580131|NCT03001076|183049995|SUPERIORITY||Difference in LS mean|-5.89|STANDARD_ERROR_OF_MEAN|1.845|=|0.002|TWO_SIDED|95.0|-9.528|-2.25|||ANCOVA|||||-2.250|-9.528|=0.002
91580132|NCT03001076|183049997|SUPERIORITY||Difference in LS mean|-31.09|STANDARD_ERROR_OF_MEAN|2.238|<|0.001|TWO_SIDED|95.0|-35.498|-26.682|||ANCOVA|||Change from Baseline to Week 4||-26.682|-35.498|<0.001
91580133|NCT03001076|183049997|SUPERIORITY||Difference in LS mean|-29.12|STANDARD_ERROR_OF_MEAN|2.513|<|0.001|TWO_SIDED|95.0|-34.074|-24.168|||ANCOVA|||Change from Baseline to Week 8||-24.168|-34.074|<0.001
91580134|NCT03001076|183049998|SUPERIORITY||Difference in LS mean|-25.26|STANDARD_ERROR_OF_MEAN|2.004|<|0.001|TWO_SIDED|95.0|-29.204|-21.308|||ANCOVA|||Change from Baseline to Week 4||-21.308|-29.204|<0.001
91580135|NCT03001076|183049998|SUPERIORITY||Difference in LS mean|-23.75|STANDARD_ERROR_OF_MEAN|2.268|<|0.001|TWO_SIDED|95.0|-28.219|-19.276|||ANCOVA|||Change from Baseline to Week 8||-19.276|-28.219|<0.001
91580136|NCT03001076|183049999|SUPERIORITY||Difference in LS mean|-20.41|STANDARD_ERROR_OF_MEAN|1.513|<|0.001|TWO_SIDED|95.0|-23.39|-17.43|||ANCOVA|||Change from Baseline to Week 4||-17.430|-23.390|<0.001
91580137|NCT03001076|183049999|SUPERIORITY||Difference in LS mean|-18.46|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-21.71|-15.206|||ANCOVA|||Change from Baseline to Week 8||-15.206|-21.710|<0.001
91580138|NCT03001076|183050000|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|4.99|=|0.873|TWO_SIDED|95.0|-10.663|9.059|||ANCOVA|||Change from Baseline to Week 4||9.059|-10.663|=0.873
91580139|NCT03001076|183050000|SUPERIORITY||Difference in LS mean|-0.08|STANDARD_ERROR_OF_MEAN|5.131|=|0.988|TWO_SIDED|95.0|-10.215|10.055|||ANCOVA|||Change from Baseline to Week 8||10.055|-10.215|=0.988
91580140|NCT03001076|183050001|SUPERIORITY||Difference in LS mean|-8.59|STANDARD_ERROR_OF_MEAN|1.619|<|0.001|TWO_SIDED|95.0|-11.778|-5.394|||ANCOVA|||Change from Baseline to Week 4||-5.394|-11.778|<0.001
91580141|NCT03001076|183050001|SUPERIORITY||Difference in LS mean|-6.42|STANDARD_ERROR_OF_MEAN|1.712|<|0.001|TWO_SIDED|95.0|-9.798|-3.049|||ANCOVA|||Change from Baseline to Week 8||-3.049|-9.798|<0.001
91580142|NCT02576587|183050084|OTHER|Conditional logistic regression was used to assess the relationship of PAF and AHI on matched pairs of case and control.|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.007||0.054|TWO_SIDED|95.0|0.97|1.0|||Conditional logistic regression|||||1.00|0.97|0.054
91580143|NCT02576587|183050084|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume on matched pairs of case and control.|Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.007||0.014|TWO_SIDED|95.0|1.0|1.03|||Conditional logistic regression|N = 270 (135 cases and 135 controls)||||1.03|1.00|0.014
91580144|NCT02576587|183050084|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume index on matched pairs of case and control.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.015||0.03|TWO_SIDED|95.0|1.0|1.06|||Conditional logistic regression|N=268 (134 cases and 134 controls)||||1.06|1.00|0.030
91580145|NCT02576587|183050084|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical four-chamber (A4C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.39|TWO_SIDED|95.0|0.96|1.01|||Conditional logistic regression|N=214 (107 cases and 107 controls)||||1.01|0.96|0.39
91580146|NCT02576587|183050084|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical two-chamber (A2C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.49|TWO_SIDED|95.0|0.97|1.02|||Conditional logistic regression|N=212 (106 cases and 106 controls)||||1.02|0.97|0.49
91580147|NCT02576587|183050085|OTHER||median of change|3.4||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|||Inter-Quartile Range of the change (post minus pre) is (-7.0, 13.7).|||0.16
91580148|NCT02576587|183050086|OTHER||median of change|1.8||||0.088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-2.0, 6.0).|||||0.088
91580149|NCT02576587|183050087|OTHER||median of change|-3.7||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-8.0, -0.57).|||||0.006
91580150|NCT02576587|183050088|OTHER||median of change|-0.7||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-6.2, 10.7).|||||0.59
91580151|NCT02576587|183050089|OTHER||mean of change|0.62|STANDARD_DEVIATION|4.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
91580152|NCT02576587|183050090|OTHER||mean of change|-1.7|STANDARD_DEVIATION|12.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
91580153|NCT01056718|183050094|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.||||<0.05
91580154|NCT01056718|183050095|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580155|NCT01056718|183050096|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580156|NCT01056718|183050097|SUPERIORITY_OR_OTHER||||||=|0.078|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.078
91580157|NCT01056718|183050098|SUPERIORITY_OR_OTHER||||||=|0.186|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.186
91580158|NCT01056718|183050099|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580159|NCT01056718|183050100|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580160|NCT01056718|183050101|SUPERIORITY_OR_OTHER||||||=|0.06|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.06
91580161|NCT01056718|183050102|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580162|NCT01056718|183050103|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580163|NCT01056718|183050104|SUPERIORITY_OR_OTHER||||||=|0.85|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.85
91580164|NCT01056718|183050105|SUPERIORITY_OR_OTHER||||||=|0.4|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.40
91580165|NCT01056718|183050106|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
91580166|NCT01056718|183050107|SUPERIORITY_OR_OTHER||||||=|0.49|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.49
91580167|NCT01056718|183050108|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.47
91580168|NCT01056718|183050109|SUPERIORITY_OR_OTHER||||||=|0.55|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.55
91580169|NCT01056718|183050110|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
91580170|NCT01056718|183050111|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580171|NCT01056718|183050112|SUPERIORITY_OR_OTHER||||||=|0.526|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.526
91580172|NCT01056718|183050113|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580173|NCT01056718|183050114|SUPERIORITY_OR_OTHER||||||=|0.925|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.925
91580174|NCT01056718|183050115|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
91580175|NCT01056718|183050116|SUPERIORITY_OR_OTHER||||||=|0.458|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.458
91580176|NCT01056718|183050117|SUPERIORITY_OR_OTHER||||||=|0.561|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.561
91580177|NCT01056718|183050118|SUPERIORITY_OR_OTHER||||||=|0.734|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.734
91580178|NCT01056718|183050119|SUPERIORITY_OR_OTHER||||||=|0.129|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.129
91580179|NCT00738894|183050128|SUPERIORITY|This is the first of two primary outcomes for this study. Assumptions for power calculations: expected event free for medical management 92% at 24 months; expected event free for device closure 96.4% at 24 months (55% risk reduction); 664 subjects randomly assigned 2:1 to device closure or medical management provides 80% power with 15% attrition (over 5 years) and 1-sided alpha = 0.024 to allow for interim analysis (interim analysis later rescinded from plan).|Hazard Ratio (HR)|0.23||||0.001|TWO_SIDED|95.0|0.09|0.62||1-sided p-value was adjusted for multiplicity with 2nd primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|Log Rank||Hazard ratio (test/control) obtained from Cox proportional hazards model with treatment arm as sole explanatory variable, the exponentiated coefficient of which provided the hazard ratio. Unadjusted for multiplicity.|"Test null hypothesis of equal or lower recurrent stroke-free survivorship for device closure compared to medical management.~H0: Sd(t) ≤ Sm(t) for all t, versus H1: Sd(t) \> Sm(t) for all t, where Sd(t) and Sm(t) are true Kaplan-Meier product-limit survivor functions for the device closure and medical management arms and t is time from randomization to event or censoring.~Event-free subjects were censored at time of last follow-up. Significance threshold (1-sided alpha) = 0.025."||0.62|0.09|0.001
91580180|NCT00738894|183050129|SUPERIORITY|This is the second of two primary outcomes for this study. Assumptions for power calculations: expected proportion of brain infarct is 3-7 times the clinical stroke rate; expected brain infarct proportion for medical management 14.5% (2.9% clinical stroke x 5); expected brain infarct for device closure 6.5% (55% risk reduction); 597 subjects (10% attrition from 664) provides 73% power with 1-sided alpha = 0.0125 (based conservatively on a Bonferroni adjustment of alpha/2).|Risk Difference (RD)|0.056||||0.024|TWO_SIDED|95.0|0.003|0.108||1-sided p-value was adjusted for multiplicity with 1st primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|z-test, 1-sided||Unadjusted for multiplicity.|"Test null hypothesis of equal or higher proportion with brain infarct for device closure compared to medical management.~H0: Pm - Pd ≤ 0, versus H1: Pm - Pd \> 0, where Pd and Pm are true proportions of subjects with brain infarct for the device closure and medical management arms.~Significance threshold (1-sided alpha) = 0.025."||0.108|0.003|0.024
91580181|NCT02656329|183050133|NON_INFERIORITY|Non-inferiority of AdreView™ group over SoC group was demonstrated if upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) (AdreView™ group / SoC) was equal to 1.20.|Hazard Ratio (HR)|1.047||||0.8459|TWO_SIDED|95.0|0.295|3.719||Threshold for significance at 0.025 level.|Log Rank||AdreView™ vs. Standard of Care|Analysis was performed using the Cox proportional hazards model stratified by country, with method of treatment guidance (SoC vs AdreView™ group) as the only covariate.||3.719|0.295|0.8459
91580182|NCT00719329|183050155|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.7|0.81|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Single CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.81|0.70|
91580183|NCT00719329|183050155|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.71|||||TWO_SIDED|95.0|0.66|0.77|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.77|0.66|
91580184|NCT00719329|183050156|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.78|||||TWO_SIDED|95.0|0.74|0.82|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.82|0.74|
91580185|NCT00719329|183050156|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.61|||||TWO_SIDED|95.0|0.57|0.65|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.65|0.57|
91580186|NCT00719329|183050157|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.89|0.96|||Binomial Regression, Log Link|General Estimating Equations to adjust for clustered allocation|Prevalence Rate Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.96|0.89|
91580187|NCT00719329|183050157|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.57|||||TWO_SIDED|95.0|0.53|0.63|||Binomial Regression, Log Link|General Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.63|0.53|
91580188|NCT02186600|183050205|OTHER|Hierarchical linear modeling for intent-to-treat analysis to analyze time X group interactions, adjusted for baseline total body lean mass and height.||||||0.7|||||||hierarchical linear modeling|controlled for total lean mass and height||||||0.7
91580189|NCT02186600|183050206|OTHER|hierarchical linear modeling||||||0.01|||||||hierarchical linear modeling|||||||0.01
91580190|NCT02186600|183050207|OTHER|Hierarchical linear modeling|||||<|0.007|||||||hierarchical linear modeling|||||||<0.007
91580191|NCT03026075|183050208|SUPERIORITY||||||<|0.01|||||||McNemar|||"The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)"||||<0.01
91580192|NCT00452426|183050243|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||ANOVA|||||||0.028
91580193|NCT00452426|183050245|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANOVA|||||||0.007
91580194|NCT00452426|183050246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91580195|NCT03541174|183050248|SUPERIORITY||LS Mean difference to placebo|-3.79||||0.0042|TWO_SIDED|97.5|-6.76|-0.82||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.82|-6.76|0.0042
91580196|NCT03541174|183050248|SUPERIORITY||LS Mean difference to placebo|-3.73||||0.0046|TWO_SIDED|97.5|-6.67|-0.78||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.78|-6.67|0.0046
91580197|NCT03541174|183050249|SUPERIORITY||LS mean difference to placebo.|-5.82|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.71||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiSBP = DB-WD baseline SiSBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + DB-WD baseline x visit.|Mixed Models Analysis|||||-3.71|-7.94|<0.0001
91580198|NCT03541174|183050250|OTHER||LS Mean difference to placebo|-3.94|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.31||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.31|-5.57|<0.0001
91580199|NCT03541174|183050250|OTHER||LS Mean difference to placebo|-4.47|||<|0.0001|TWO_SIDED|95.0|-6.09|-2.85||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.85|-6.09|<0.0001
91580200|NCT03541174|183050251|OTHER||LS Mean difference to placebo|-4.18|||<|0.0001|TWO_SIDED|95.0|-6.25|-2.12|||ANCOVA|||24-hour mean systolic (SBP)||-2.12|-6.25|<0.0001
91580201|NCT03541174|183050251|OTHER||LS Mean difference to placebo|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.85|||ANCOVA|||24-hour mean systolic (SBP)||-3.85|-7.94|<0.0001
91580202|NCT03541174|183050251|OTHER||LS Mean difference to placebo|-4.32|||<|0.0001|TWO_SIDED|95.0|-5.66|-2.98|||ANCOVA|||24-hour mean diastolic (DBP)||-2.98|-5.66|<0.0001
91580203|NCT03541174|183050251|OTHER||LS Mean|-5.81|||<|0.0001|TWO_SIDED|95.0|-7.14|-4.49|||ANCOVA|||24-hour mean diastolic (DBP)||-4.49|-7.14|<0.0001
91580204|NCT03541174|183050252|OTHER||LS Mean difference to placebo|-5.19|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.76||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiDBP = Double-blind withdrawal baseline SiDBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + Double-blind withdrawal baseline x visit.|Mixed Models Analysis|||||-3.76|-6.62|<0.0001
91580205|NCT03541174|183050253|OTHER||LS Mean difference to placebo|-6.53|||<|0.0001|TWO_SIDED|95.0|-8.5|-4.56|||ANCOVA|||24-hour mean systolic (SBP)||-4.56|-8.50|<0.0001
91580206|NCT03541174|183050253|OTHER||LSM Mean difference to placebo|-6.75|||<|0.0001|TWO_SIDED|95.0|-7.98|-5.52|||ANCOVA|||24-hour mean diastolic (DBP)||-5.52|-7.98|<0.0001
91580207|NCT00605215|183050254|OTHER||Risk Ratio (RR)|0.823|STANDARD_ERROR_OF_MEAN|0.09||0.0746|TWO_SIDED|95.0|0.664|1.02||Threshold for significance at 0.05 level.|Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||1.020|0.664|0.0746
91580208|NCT00605215|183050254|OTHER||Risk Ratio (RR)|0.741|STANDARD_ERROR_OF_MEAN|0.082||0.0067|TWO_SIDED|95.0|0.596|0.92|||Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||0.920|0.596|0.0067
91580209|NCT00275262|183050270|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.125
91580210|NCT00275262|183050271|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.299
91580211|NCT01131182|183050385|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0||||Assessed for relative risk using prior therapy (monotherapy or combination therapy) as a stratification factor.|Cochran-Mantel-Haenszel|||||||0.0005
91580212|NCT05086276|183050394|SUPERIORITY||Odds Ratio (OR)|1.4||||0.525|TWO_SIDED|95.0|0.51|3.73||P value for statistical significance is \<0.05|Chi-squared|||||3.73|0.51|0.525
91580213|NCT05086276|183050394|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.525|TWO_SIDED|95.0|-7.52|14.71||P value for statistical significance is \<0.05|Chi-squared|||||14.71|-7.52|0.525
91580214|NCT05086276|183050395|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.491||0.973|TWO_SIDED|95.0|-0.954|0.987||P value for statistical significance is \<0.05|Mixed Models Analysis|||||0.987|-0.954|0.973
91580215|NCT05086276|183050397|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.16|TWO_SIDED|95.0|-0.06|0.34||P value for statistical significance is \<0.05|ANCOVA|||||0.34|-0.06|0.160
91580216|NCT05086276|183050398|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.027|TWO_SIDED|95.0|0.03|0.41||P value for statistical significance is \<0.05|ANCOVA|||||0.41|0.03|0.027
91580217|NCT00777088|183050399|NON_INFERIORITY|The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up|||||<|0.001|||||||Bayesian|||||||<.001
91580218|NCT00777088|183050400|NON_INFERIORITY_OR_EQUIVALENCE|The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability \>0.975.|||||<|0.001|||||||Bayesian|||||||<0.001
91580219|NCT00633880|183050408|SUPERIORITY_OR_OTHER|||||||0.509||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the primary endpoint was not positive, statistical analysis was not performed on secondary endpoints.|Wilcoxon (Mann-Whitney)|||||||0.509
91580220|NCT00633880|183050413|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
91580221|NCT04927247|183050442|OTHER||Difference in percentage|7.9||||0.6302|TWO_SIDED|95.0|-15.8|31.7|||Exact Cochran-Mantel-Haenszel test|||||31.7|-15.8|0.6302
91580222|NCT04927247|183050443|OTHER||Hazard Ratio (HR)|0.97||||0.9382|TWO_SIDED|95.0|0.43|2.16|||Stratified log-rank test|||||2.16|0.43|0.9382
91580223|NCT04927247|183050444|OTHER||Difference in percentage|-16.8||||0.1143|TWO_SIDED|95.0|-34.4|0.8|||Exact Cochran-Mantel-Haenszel test|||||0.8|-34.4|0.1143
91580224|NCT04927247|183050445|OTHER||Rate ratio|1.09||||0.7549|TWO_SIDED|95.0|0.63|1.89|||Negative binomial model|||||1.89|0.63|0.7549
91580225|NCT02001064|183050446|SUPERIORITY||Odds Ratio (OR)|2.3||||0.32|TWO_SIDED||||||t-test, 1 sided|||||||0.32
91580226|NCT02001064|183050447|SUPERIORITY|||||||0.073||||||Cohen's d (ranks) = -.049|Wilcoxon (Mann-Whitney)|||||||0.073
91580227|NCT02001064|183050448|SUPERIORITY|||||||0.24||||||Cohen's d=0.31|Wilcoxon (Mann-Whitney)|||||||0.24
91580228|NCT01468181|183050454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-1.87|-1.67|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 26 Weeks||-1.67|-1.87|<0.001
91580229|NCT01468181|183050454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||<|0.001|TWO_SIDED|95.0|-1.75|-1.55|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 52 Weeks||-1.55|-1.75|<0.001
91580230|NCT01468181|183050456|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-43.9|||<|0.001|TWO_SIDED|95.0|-47.8|-40.0|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 26 Weeks||-40.0|-47.8|<0.001
91580231|NCT01468181|183050456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.4|-38.7|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 52 Weeks||-38.7|-46.4|<0.001
91580232|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.42|||<|0.001|TWO_SIDED|95.0|-46.55|-38.29|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 26 Weeks||-38.29|-46.55|<0.001
91580233|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.44|-38.76|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 52 Weeks||-38.76|-46.44|<0.001
91580234|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.48|||<|0.001|TWO_SIDED|95.0|-74.18|-62.79|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 26 Weeks||-62.79|-74.18|<0.001
91580235|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.08|||<|0.001|TWO_SIDED|95.0|-72.12|-60.04|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 52 Weeks||-60.04|-72.12|<0.001
91580236|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.21|||<|0.001|TWO_SIDED|95.0|-53.32|-43.09|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 26 Weeks||-43.09|-53.32|<0.001
91580237|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.51|||<|0.001|TWO_SIDED|95.0|-52.77|-42.24|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 52 Weeks||-42.24|-52.77|<0.001
91580238|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.06|||<|0.001|TWO_SIDED|95.0|-73.02|-61.11|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 26 Weeks||-61.11|-73.02|<0.001
91580239|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.17|||<|0.001|TWO_SIDED|95.0|-69.16|-57.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 52 Weeks||-57.18|-69.16|<0.001
91580240|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-49.67|-38.34|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 26 Weeks||-38.34|-49.67|<0.001
91580241|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.88|||<|0.001|TWO_SIDED|95.0|-49.55|-38.21|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 52 Weeks||-38.21|-49.55|<0.001
91580242|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.91|||<|0.001|TWO_SIDED|95.0|-69.32|-56.5|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 26 Weeks||-56.50|-69.32|<0.001
91580243|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.84|||<|0.001|TWO_SIDED|95.0|-66.95|-54.74|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 52 Weeks||-54.74|-66.95|<0.001
91580244|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.15|||<|0.001|TWO_SIDED|95.0|-66.93|-55.37|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 26 Weeks||-55.37|-66.93|<0.001
91580245|NCT01468181|183050457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.16|||<|0.001|TWO_SIDED|95.0|-66.07|-54.25|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 52 Weeks||-54.25|-66.07|<0.001
91580246|NCT01468181|183050458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|||<|0.277|TWO_SIDED|95.0|-0.4|0.12|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 26 Weeks||0.12|-0.40|<0.277
91580247|NCT01468181|183050458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.382|TWO_SIDED|95.0|-0.42|0.16|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 52 Weeks||0.16|-0.42|0.382
91580248|NCT01468181|183050459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.59|||<|0.001|TWO_SIDED|95.0|26.0|31.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 26 Weeks||31.18|26.00|<0.001
91580249|NCT01468181|183050459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.57|||<|0.001|TWO_SIDED|95.0|24.73|30.41|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 52 Weeks||30.41|24.73|<0.001
91580250|NCT01468181|183050459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.194|TWO_SIDED|95.0|-6.46|1.32|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 26 Weeks||1.32|-6.46|0.194
91580251|NCT01468181|183050459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.4|TWO_SIDED|65.0|-5.68|2.27|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 52 Weeks||2.27|-5.68|0.400
91580252|NCT00878826|183050460|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||at 14-18 weeks gestational age||||0.4
91580253|NCT00878826|183050460|SUPERIORITY_OR_OTHER|||||||0.9|||||||Kruskal-Wallis|||at 24-28 weeks gestational age||||0.9
91580254|NCT00878826|183050460|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||at 32-34 weeks gestational age||||0.3
91580255|NCT00513305|183050466|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED|95.0||||The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.|Chi-squared|There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced||The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.||||0.425
91580256|NCT00513305|183050467|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.829|TWO_SIDED|95.0|0.535|1.973|||Log Rank|||||1.973|0.535|0.829
91580257|NCT00513305|183050468|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.31||||0.527|TWO_SIDED|95.0|0.16|33.343|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||33.343|0.160|0.527
91580258|NCT00513305|183050471|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.8289|TWO_SIDED|95.0|0.535|1.973|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||1.973|0.535|0.8289
91580259|NCT01011153|183050483|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes computed based on data from smaller studies provided 90% power for the comparison of sensitivity. Under the alternative hypothesis that the biopsy sensitivity of MelaFind would be 0.10 greater than the average biopsy/referral sensitivity of physicians (combined or separate), the probability that a 95% CI lies entirely above zero will be at least 90% when the standard error of the estimated difference is at most 0.0308.|Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.18|0.32|||ANOVA|||Using True Positives/All Positives, sensitivity values were calculated for MelaFind as well as the average of the 110 dermatologists.||0.32|0.18|<0.0001
91580260|NCT01011153|183050484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.19|0.34|||ANOVA|||Sensitivity||0.34|0.19|<0.0001
91580261|NCT01011153|183050484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.16|0.31|||ANOVA|||Sensitivity||0.31|0.16|<0.0001
91580262|NCT01011153|183050484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.19|0.33|||ANOVA|||Sensitivity||0.33|0.19|<0.0001
91580263|NCT01011153|183050484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.46|-0.25|||ANOVA|||Specificity||-0.25|-0.46|<0.0001
91580264|NCT01011153|183050484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.31|||ANOVA|||Specificity||-0.31|-0.53|<0.0001
91580265|NCT01011153|183050484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.51|-0.3|||ANOVA|||Specificity||-0.30|-0.51|<0.0001
91580266|NCT01011153|183050485|SUPERIORITY_OR_OTHER||Kappa|0.313|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made.|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
91580267|NCT01011153|183050485|SUPERIORITY_OR_OTHER||Kappa|0.276|STANDARD_ERROR_OF_MEAN|0.002||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
91580268|NCT01011153|183050485|SUPERIORITY_OR_OTHER||Kappa|0.2|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
91580269|NCT01011153|183050485|SUPERIORITY_OR_OTHER||Kappa|0.256|STANDARD_ERROR_OF_MEAN|0.001||||0.0||||N/A - No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
91580270|NCT03014479|183050497|SUPERIORITY||Differences of Least Square Means|2.418||||0.2305|TWO_SIDED|95.0|-1.546|6.382|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||6.382|-1.546|0.2305
91580271|NCT03014479|183050498|SUPERIORITY||Differences of Least Square Means|1.938||||0.4536|TWO_SIDED|95.0|-3.15|7.027|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||7.027|-3.150|0.4536
91580272|NCT03014479|183050499|SUPERIORITY||Differences of Least Square Means|4.16||||0.0896|TWO_SIDED|95.0|-0.649|8.968|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.968|-0.649|0.0896
91580273|NCT03014479|183050500|SUPERIORITY||Differences of Least Square Means|-0.563||||0.8506|TWO_SIDED|95.0|-6.448|5.323|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||5.323|-6.448|0.8506
91580274|NCT03014479|183050501|SUPERIORITY||Differences of Least Square Means|2.696||||0.3533|TWO_SIDED|95.0|-3.018|8.41|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.410|-3.018|0.3533
91580275|NCT03014479|183050503|SUPERIORITY||Differences of Least Square Means|0.613||||0.5451|TWO_SIDED|95.0|-1.38|2.605|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||2.605|-1.380|0.5451
91580276|NCT01081132|183050525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.026|||<|0.001|TWO_SIDED|95.0|-8.865|-3.187|||Mixed Models Repeated Measures Analysis|||||-3.187|-8.865|<0.001
91580277|NCT01081132|183050526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Cochran-Mantel-Haenszel|||||||0.010
91580278|NCT01081132|183050527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.115||||0.104|TWO_SIDED|95.0|-0.254|0.024|||Mixed Models Repeated Measures Analysis|||||0.024|-0.254|0.104
91580279|NCT01081132|183050528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057||||0.408|TWO_SIDED|95.0|-0.192|0.078|||Mixed Models Repeated Measures Analysis|||||0.078|-0.192|0.408
91580280|NCT01081132|183050529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.083||||0.176|TWO_SIDED|95.0|-0.203|0.037|||Mixed Models Repeated Measures Analysis|||||0.037|-0.203|0.176
91580281|NCT01081132|183050530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05||||0.253|TWO_SIDED|95.0|-0.136|-0.036|||Mixed Models Repeated Measures Analysis|||||-0.036|-0.136|0.253
91580282|NCT01081132|183050531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.004||||0.912|TWO_SIDED|95.0|-0.061|0.068|||Mixed Models Repeated Measures Analysis|||||0.068|-0.061|0.912
91580283|NCT01081132|183050532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029||||0.606|TWO_SIDED|95.0|-0.139|0.081|||Mixed Models Repeated Measures Analysis|||||0.081|-0.139|0.606
91580284|NCT01081132|183050533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102||||0.228|TWO_SIDED|95.0|-0.064|0.268|||Mixed Models Repeated Measures Analysis|||||0.268|-0.064|0.228
91580285|NCT01081132|183050534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.41|TWO_SIDED|95.0|-0.159|0.065|||Mixed Models Repeated Measures Analysis|||||0.065|-0.159|0.410
91580286|NCT01081132|183050535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.208||||0.082|TWO_SIDED|95.0|-0.443|0.026|||Mixed Models Repeated Measures Analysis|||||0.026|-0.443|0.082
91580287|NCT01081132|183050536|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91580288|NCT01081132|183050537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.134|TWO_SIDED|95.0|-5.3|0.7|||Mixed Models Repeated Measures Analysis|||Global Executive Composite||0.7|-5.3|0.134
91580289|NCT01081132|183050537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.579|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Repeated Measures Analysis|||Behavioral Regulation Index||2.3|-4.0|0.579
91580290|NCT01081132|183050537|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.072|TWO_SIDED|95.0|-5.6|0.2|||Mixed Models Repeated Measures Analysis|||Metacognition Index||0.2|-5.6|0.072
91580291|NCT01081132|183050538|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.465|TWO_SIDED|95.0|-1.8|0.8|||Mixed Models Repeated Measures Analysis|||||0.8|-1.8|0.465
91580292|NCT02489968|183050549|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.97|-0.67|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)|||-0.67|-0.97|<0.0001
91580293|NCT02489968|183050549|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.73|-0.45|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)|||-0.45|-0.73|<0.0001
91580294|NCT03973931|183050560|NON_INFERIORITY|Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations|||||<|0.05|||||||GEE|To account for multiple treatment comparisons significance levels of 0.05/3||||||<0.05
91580295|NCT03973931|183050561|NON_INFERIORITY|Analysis of the longitudinal data (12 observations per patient) and estimated absolute differences in PDC between treatment group and usual care was analyzed using Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure was used.|||||<|0.05||||||To account for multiple treatment comparisons significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, R=number of significant stage 1 tests.|GEE|||||||<0.05
91580296|NCT00432666|183050565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|1.49|<|0.001|TWO_SIDED|95.0|1.9|8.3|||Regression, Logistic|||The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.||8.30|1.90|<0.001
91580297|NCT00705679|183050701|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.37|TWO_SIDED|95.0|0.61|1.21||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.21|0.61|0.37
91580298|NCT00705679|183050704|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.07|TWO_SIDED|95.0|0.97|2.29||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||2.29|0.97|0.07
91580299|NCT00705679|183050707|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.73|1.49||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.49|0.73|0.81
91580300|NCT00705679|183050708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||Fisher Exact|Two-sided Fisher's Exact Test.||||||0.004
91580301|NCT03527173|183050709|NON_INFERIORITY|VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.|Vaccine efficacy rate|-9.4||||0.4266|TWO_SIDED|90.0|-96.7|33.7|||1-sided Barnard Unconditional Exact Test|||To demonstrate the efficacy of two vaccinations with 25 µg of S. sonnei vaccine in healthy adults compared to placebo in preventing shigellosis, fulfilling the protocol primary case definition, after challenge with S. sonnei 53G strain. Vaccine efficacy (VE) rate was assessed as 1-Risk Ratio(RR) with RR = ratio of proportion of subjects with shigellosis in the vaccinated group on the proportion of subjects with shigellosis in the placebo group.||33.7|-96.7|0.4266
91580302|NCT02704754|183050728|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
91580303|NCT03730480|183050741|OTHER|count of number of results within 15% of reference analyzer||||||||||||||||count of number of responses|The number of results that are within 15% of reference analyzer is reported.|||
91580304|NCT01248780|183050743|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91580305|NCT01248780|183050744|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91580306|NCT01248780|183050745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91580307|NCT01248780|183050746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
91580308|NCT00107120|183050749|SUPERIORITY_OR_OTHER||Least Square Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.458||0.022||95.0|-6.2|-0.5||Two-sided at 5% level of significance p \< 0.05 considered significant|ANCOVA|The model included study center and treatment as factors and baseline core as covariate|Differences are Escitalopram-Placebo|The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.||-0.5|-6.2|0.022
91580309|NCT00107120|183050750|SUPERIORITY_OR_OTHER||Least Square Means Difference|-0.344|STANDARD_ERROR_OF_MEAN|0.1128||0.008||95.0|-0.595|0.092||Two-sided at 5% level of significance|ANCOVA|The model included treatment and center as factors and baseline CGI-Severity score as covariate.|Differences are Escitalopram-Placebo|Missing values were imputed using the LOCF approach.||0.092|-0.595|0.008
91580310|NCT00107120|183050751|SUPERIORITY_OR_OTHER||Least Square Means Difference|2.169|STANDARD_ERROR_OF_MEAN|1.324||0.103||95.0|-0.439|4.777||Two-sided at 5% level of significance|ANCOVA||Differences are Escitalopram-Placebo|ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.||4.777|-0.439|0.103
91580311|NCT00896051|183050756|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.82|||||TWO_SIDED|90.0|0.55|1.22|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: minimum plasma concentration (Cmin)||1.22|0.55|
91580312|NCT00896051|183050756|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.8|1.16|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.16|0.80|
91580313|NCT00896051|183050757|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.96|||||TWO_SIDED|90.0|0.76|1.22|||Linear mixed effects model|linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.22|0.76|
91580314|NCT00896051|183050758|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.91|||||TWO_SIDED|90.0|0.63|1.33|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: Minimum plasma concentration (Cmin)||1.33|0.63|
91580315|NCT00896051|183050758|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|1.05|||||TWO_SIDED|90.0|0.86|1.27|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.27|0.86|
91580316|NCT00896051|183050759|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.21|||Llinear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.21|0.81|
91580317|NCT00210470|183050779|EQUIVALENCE|The correlation of each of the above variables at biopsy/Day 1, surgery/Day 21, and change with percent change in the longest diameter (LD) of the primary tumor was calculated using Spearman rank correlations (183 correlations). Due to outliers in the distribution of percent change in the longest diameter, it was felt that the Spearman rank correlations would be more appropriate than Pearson correlations.|||||<|0.1|||||||Spearman Rank|||||||<0.10
91580318|NCT00007345|183050820|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.|Cochran-Armitage trend test|||||||<0.01
91580319|NCT04433585|183050825|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
91580320|NCT04433585|183050825|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
91580321|NCT04433585|183050825|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
91580322|NCT04433585|183050826|SUPERIORITY||Odds Ratio (OR)|1.89||||0.131|TWO_SIDED|95.0|0.83|4.3|||Regression, Logistic|||||4.30|0.83|0.131
91580323|NCT04433585|183050826|SUPERIORITY||Odds Ratio (OR)|1.09||||0.844|TWO_SIDED|95.0|0.47|2.5|||Regression, Logistic|||||2.50|0.47|0.844
91580324|NCT04433585|183050826|SUPERIORITY||Odds Ratio (OR)|0.57||||0.218|TWO_SIDED|95.0|0.24|1.39|||Regression, Logistic|||||1.39|0.24|0.218
91580325|NCT04433585|183050827|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
91580326|NCT04433585|183050827|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
91580327|NCT04433585|183050827|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
91580328|NCT04433585|183050828|SUPERIORITY||Odds Ratio (OR)|1.91||||0.203|TWO_SIDED|95.0|0.71|5.2|||Regression, Logistic|||||5.20|0.71|0.203
91580329|NCT04433585|183050828|SUPERIORITY||Odds Ratio (OR)|1.1||||0.865|TWO_SIDED|95.0|0.38|3.16|||Regression, Logistic|||||3.16|0.38|0.865
91580330|NCT04433585|183050828|SUPERIORITY||Odds Ratio (OR)|1.07||||0.896|TWO_SIDED|95.0|0.38|3.05|||Regression, Logistic|||||3.05|0.38|0.896
91580331|NCT00704379|183050841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6|||<|0.05|TWO_SIDED|95.0|1.1|16.2|||Log Rank|||||16.2|1.1|<0.05
91580332|NCT02015455|183050854|SUPERIORITY||Percent Difference in Median|-0.7||||0.54|TWO_SIDED|95.0|-2.9|1.5|||Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, and site time trends. Random effects for clinic and provider.|Percent difference in median of the intervention group with respect to the control group.|||1.5|-2.9|0.54
91580333|NCT02015455|183050855|SUPERIORITY||Odds Ratio (OR)|0.95||||0.04|TWO_SIDED|95.0|0.91|1.0||A p-value \<0.05 was considered significant.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.00|0.91|0.04
91580334|NCT02015455|183050856|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.9|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.90|0.02
91580335|NCT02015455|183050857|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.91|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.91|0.02
91580336|NCT02015455|183050861|SUPERIORITY||Odds Ratio (OR)|0.99||||0.74|TWO_SIDED|95.0|0.91|1.07||Statistical significance defined as P\<0.05|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.07|0.91|0.74
91580337|NCT00741390|183050887|SUPERIORITY_OR_OTHER||Percentage|99.59||||||95.0|98.09|99.59||||||||99.59|98.09|
91580338|NCT00741390|183050887|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|98.79|100.0||||||||100|98.79|
91517219|NCT01972841|182908254|SUPERIORITY||Least squares mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.34||0.001|TWO_SIDED|95.0|-1.83|-0.48|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.48|-1.83|0.001
91517220|NCT01972841|182908254|SUPERIORITY||Least squares mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.34||0.14|TWO_SIDED|95.0|-1.18|0.17|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.17|-1.18|0.140
91517221|NCT01972841|182908254|SUPERIORITY||Least squares mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.88|-0.54|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.54|-1.88|<0.001
91517222|NCT01972841|182908255|SUPERIORITY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.065|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.065
91517223|NCT01972841|182908255|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
91517224|NCT01972841|182908255|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.02|-0.18|0.100
91517225|NCT01972841|182908255|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
91517226|NCT01972841|182908256|SUPERIORITY||Rate ratio|1.01|STANDARD_ERROR_OF_MEAN|0.12||0.938|TWO_SIDED|95.0|0.8|1.27|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.27|0.80|0.938
91517227|NCT01972841|182908256|SUPERIORITY||Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.12||0.967|TWO_SIDED|95.0|0.79|1.25|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.25|0.79|0.967
91517228|NCT01972841|182908256|SUPERIORITY||Standard Error of the Mean|0.73|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|95.0|0.58|0.92|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.92|0.58|0.008
91517229|NCT01972841|182908256|SUPERIORITY||Rate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.12||0.069|TWO_SIDED|95.0|0.64|1.02|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.02|0.64|0.069
91517230|NCT01972841|182908257|SUPERIORITY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.86||0.958|TWO_SIDED|95.0|-1.73|1.64|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.64|-1.73|0.958
91517231|NCT01972841|182908257|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.86||0.5|TWO_SIDED|95.0|-2.27|1.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.11|-2.27|0.500
91517232|NCT01972841|182908257|SUPERIORITY||Least squares mean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.87||0.028|TWO_SIDED|95.0|-3.62|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-3.62|0.028
91517233|NCT01972841|182908257|SUPERIORITY||Least squares mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.108|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.31|-3.13|0.108
91517234|NCT01972841|182908258|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.993|TWO_SIDED|95.0|-0.25|0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.25|-0.25|0.993
91517235|NCT01972841|182908258|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.65|TWO_SIDED|95.0|-0.3|0.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.19|-0.30|0.650
91517236|NCT01972841|182908258|SUPERIORITY||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.13||0.035|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.52|0.035
91517237|NCT01972841|182908258|SUPERIORITY||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.169|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate||0.08|-0.43|0.169
91517238|NCT01972841|182908259|SUPERIORITY||Odds Ratio (OR)|1.37||||0.003|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.003
91517239|NCT01972841|182908259|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.004
91517240|NCT01972841|182908259|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.29|1.95|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.29|<0.001
91517241|NCT01972841|182908259|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.1|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.10|0.004
91517242|NCT01972841|182908260|SUPERIORITY||Odds Ratio (OR)|1.23||||0.039|TWO_SIDED|95.0|1.01|1.5|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.50|1.01|0.039
91517243|NCT01972841|182908260|SUPERIORITY||Odds Ratio (OR)|1.3||||0.009|TWO_SIDED|95.0|1.07|1.59|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.59|1.07|0.009
91517244|NCT01972841|182908260|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.001|TWO_SIDED|95.0|1.19|1.77|||overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.77|1.19|<0.001
91517245|NCT01972841|182908260|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.001|TWO_SIDED|95.0|1.23|1.84|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate||1.84|1.23|<0.001
91517246|NCT01972841|182908261|SUPERIORITY||Odds Ratio (OR)|1.32||||0.011|TWO_SIDED|95.0|1.07|1.64|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.64|1.07|0.011
91580339|NCT00741390|183050887|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|97.61|100.0||||||||100|97.61|
91580340|NCT00741390|183050887|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.36|100.0||||||||100|95.36|
91517247|NCT01972841|182908261|SUPERIORITY||Odds Ratio (OR)|1.41||||0.002|TWO_SIDED|95.0|1.14|1.75|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.75|1.14|0.002
91517248|NCT01972841|182908261|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.32|2.06|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.06|1.32|<0.001
91517249|NCT01972841|182908261|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.33|2.07|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.07|1.33|<0.001
91517250|NCT01972841|182908262|SUPERIORITY||Least squares mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.41|<0.001
91517251|NCT01972841|182908262|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.54|-0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.25|-0.54|<0.001
91517252|NCT01972841|182908262|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
91517253|NCT01972841|182908262|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
91517254|NCT01972841|182908264|SUPERIORITY||Least squares mean difference|3.81|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|1.69|5.94|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.94|1.69|<0.001
91517255|NCT01972841|182908264|SUPERIORITY||Least squares mean difference|4.16|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.03|6.29|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.29|2.03|<0.001
91517256|NCT01972841|182908264|SUPERIORITY||Least squares mean difference|5.02|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.88|7.15|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.15|2.88|<0.001
91517257|NCT01972841|182908264|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.09||0.002|TWO_SIDED|95.0|1.17|5.43|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.43|1.17|0.002
91517258|NCT01972841|182908265|SUPERIORITY||Least squares mean difference|4.12|STANDARD_ERROR_OF_MEAN|1.29||0.001|TWO_SIDED|95.0|1.6|6.65|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.65|1.60|0.001
91517259|NCT01972841|182908265|SUPERIORITY||Lest squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|2.34|7.4|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.40|2.34|<0.001
91517260|NCT01972841|182908265|SUPERIORITY||Least squares mean difference|6.09|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|3.55|8.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||8.63|3.55|<0.001
91517261|NCT01972841|182908265|SUPERIORITY||Least squares mean difference|3.8|STANDARD_ERROR_OF_MEAN|1.29||0.003|TWO_SIDED|95.0|1.27|6.33|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.33|1.27|0.003
91517262|NCT01972841|182908266|SUPERIORITY||Least squares mean difference|4.24|STANDARD_ERROR_OF_MEAN|1.22||0.001|TWO_SIDED|95.0|1.84|6.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.63|1.84|0.001
91517263|NCT01972841|182908266|SUPERIORITY||Least squares mean difference|4.82|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.42|7.22|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.22|2.42|<0.001
91517264|NCT01972841|182908266|SUPERIORITY||Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|2.93|7.75|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.75|2.93|<0.001
91517265|NCT01972841|182908266|SUPERIORITY||Least squares mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.01|6.81|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.81|2.01|<0.001
91517266|NCT01972841|182908267|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.85|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.85|1.98|<0.001
91517267|NCT01972841|182908267|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.86|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.86|1.98|<0.001
91517268|NCT01972841|182908267|SUPERIORITY||Least squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|2.42|7.32|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.32|2.42|<0.001
91517269|NCT01972841|182908267|SUPERIORITY||Least squares mean difference|3.28|STANDARD_ERROR_OF_MEAN|1.24||0.008|TWO_SIDED|95.0|0.84|5.72|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.72|0.84|0.008
91517270|NCT01972841|182908268|SUPERIORITY||Least squares mean difference|2.27|STANDARD_ERROR_OF_MEAN|0.99||0.022|TWO_SIDED|95.0|0.33|4.21|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.21|0.33|0.022
91517271|NCT01972841|182908268|SUPERIORITY||Least squares mean difference|2.25|STANDARD_ERROR_OF_MEAN|0.99||0.023|TWO_SIDED|95.0|0.31|4.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.19|0.31|0.023
91517272|NCT01972841|182908268|SUPERIORITY||Least squares mean difference|2.8|STANDARD_ERROR_OF_MEAN|0.99||0.005|TWO_SIDED|95.0|0.85|4.74|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.74|0.85|0.005
91517273|NCT01972841|182908268|SUPERIORITY||Least squares mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.99||0.337|TWO_SIDED|95.0|-0.99|2.89|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||2.89|-0.99|0.337
91580341|NCT00741390|183050887|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.13|100.0||||||||100|95.13|
91517274|NCT01972841|182908281|SUPERIORITY||Odds Ratio (OR)|1.31||||0.035|TWO_SIDED|95.0|1.02|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.69|1.02|0.035
91517275|NCT01972841|182908281|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.81|1.09|0.009
91517276|NCT01972841|182908281|SUPERIORITY||Odds Ratio (OR)|1.5||||0.002|TWO_SIDED|95.0|1.16|1.93|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.93|1.16|0.002
91517277|NCT01972841|182908281|SUPERIORITY||Odds Ratio (OR)|1.34||||0.023|TWO_SIDED|95.0|1.04|1.73|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.73|1.04|0.023
91517278|NCT01972841|182908282|SUPERIORITY||Odds Ratio (OR)|1.22||||0.224|TWO_SIDED|95.0|0.88|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.69|0.88|0.224
91517279|NCT01972841|182908282|SUPERIORITY||Odds Ratio (OR)|1.42||||0.037|TWO_SIDED|95.0|1.02|1.96|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.96|1.02|0.037
91517280|NCT01972841|182908282|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.001|TWO_SIDED|95.0|1.47|2.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.67|1.47|<0.001
91517281|NCT01972841|182908282|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.26|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.26|1.21|0.002
91517282|NCT01972841|182908283|SUPERIORITY||Odds Ratio (OR)|1.29||||0.077|TWO_SIDED|95.0|0.97|1.72|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.72|0.97|0.077
91517283|NCT01972841|182908283|SUPERIORITY||Odds Ratio (OR)|1.15||||0.321|TWO_SIDED|95.0|0.87|1.53|||Logistic regression|||Odds ratio from a logistic regression model treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.87|0.321
91517284|NCT01972841|182908283|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.001|TWO_SIDED|95.0|1.46|2.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.53|1.46|<0.001
91517285|NCT01972841|182908283|SUPERIORITY||Odds Ratio (OR)|1.16||||0.294|TWO_SIDED|95.0|0.88|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.88|0.294
91517286|NCT01972841|182908284|SUPERIORITY||Odds Ratio (OR)|1.17||||0.251|TWO_SIDED|95.0|0.89|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.53|0.89|0.251
91517287|NCT01972841|182908284|SUPERIORITY||Odds Ratio (OR)|1.25||||0.107|TWO_SIDED|95.0|0.95|1.64|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.64|0.95|0.107
91517288|NCT01972841|182908284|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.07|1.23|<0.001
91517289|NCT01972841|182908284|SUPERIORITY||Odds Ratio (OR)|1.41||||0.012|TWO_SIDED|95.0|1.08|1.85|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.85|1.08|0.012
91517290|NCT01972841|182908285|SUPERIORITY||Odds Ratio (OR)|1.3||||0.044|TWO_SIDED|95.0|1.01|1.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.67|1.01|0.044
91517291|NCT01972841|182908285|SUPERIORITY||Odds Ratio (OR)|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.84|1.11|0.006
91517292|NCT01972841|182908285|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.9|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.90|1.13|0.004
91517293|NCT01972841|182908285|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|2.08|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.08|1.23|<0.001
91517294|NCT01972841|182908286|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.92|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.92|1.13|0.004
91517295|NCT01972841|182908286|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.24|2.11|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.11|1.24|<0.001
91517296|NCT01972841|182908286|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.22|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.07|1.22|0.001
91517297|NCT01972841|182908286|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.04|1.21|0.001
91517298|NCT01972841|182908287|SUPERIORITY||Odds Ratio (OR)|1.32||||0.065|TWO_SIDED|95.0|0.98|1.78|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.78|0.98|0.065
91517299|NCT01972841|182908287|SUPERIORITY||Odds Ratio (OR)|1.68||||0.001|TWO_SIDED|95.0|1.24|2.27|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.27|1.24|0.001
91517300|NCT01972841|182908287|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.32|2.36|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.36|1.32|<0.001
91517301|NCT01972841|182908287|SUPERIORITY||Odds Ratio (OR)|1.51||||0.007|TWO_SIDED|95.0|1.12|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.04|1.12|0.007
91517302|NCT01972841|182908288|SUPERIORITY||Odds Ratio (OR)|1.44||||0.007|TWO_SIDED|95.0|1.11|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.87|1.11|0.007
91517303|NCT01972841|182908288|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.17|1.28|<0.001
91517304|NCT01972841|182908288|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.34|2.3|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.30|1.34|<0.001
91517305|NCT01972841|182908288|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.19|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.19|1.29|<0.001
91517306|NCT01972841|182908289|SUPERIORITY||Odds Ratio (OR)|1.12||||0.381|TWO_SIDED|95.0|0.87|1.45|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.45|0.87|0.381
91517307|NCT01972841|182908289|SUPERIORITY||Odds Ratio (OR)|1.31||||0.04|TWO_SIDED|95.0|1.01|1.7|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.70|1.01|0.040
91517308|NCT01972841|182908289|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.0|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.00|1.21|0.001
91517309|NCT01972841|182908289|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.03|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.03|1.21|0.001
91517310|NCT01972841|182908290|SUPERIORITY||Odds Ratio (OR)|1.24||||0.095|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.59|0.96|0.095
91517311|NCT01972841|182908290|SUPERIORITY||Odds Ratio (OR)|1.26||||0.073|TWO_SIDED|95.0|0.98|1.62|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.62|0.98|0.073
91517312|NCT01972841|182908290|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.13|1.29|<0.001
91517313|NCT01972841|182908290|SUPERIORITY||Odds Ratio (OR)|1.27||||0.067|TWO_SIDED|95.0|0.98|1.63|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.63|0.98|0.067
91517314|NCT01972841|182908291|SUPERIORITY||Odds Ratio (OR)|1.18||||0.21|TWO_SIDED|95.0|0.91|1.52|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.52|0.91|0.210
91517315|NCT01972841|182908291|SUPERIORITY||Odds Ratio (OR)|1.46||||0.004|TWO_SIDED|95.0|1.13|1.89|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.89|1.13|0.004
91517316|NCT01972841|182908291|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.06|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.06|1.23|<0.001
91517317|NCT01972841|182908291|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.05|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.05|1.23|<0.001
91517318|NCT01972841|182908292|SUPERIORITY||Odds Ratio (OR)|1.13||||0.335|TWO_SIDED|95.0|0.88|1.46|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.46|0.88|0.335
91517319|NCT01972841|182908292|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.81|1.09|0.009
91517320|NCT01972841|182908292|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.02|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.02|1.21|0.001
91517321|NCT01972841|182908292|SUPERIORITY||Odds Ratio (OR)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.21|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.21|1.33|<0.001
91517322|NCT01972841|182908293|SUPERIORITY||Odds Ratio (OR)|1.11||||0.416|TWO_SIDED|95.0|0.86|1.43|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.43|0.86|0.416
91517323|NCT01972841|182908293|SUPERIORITY||Odds Ratio (OR)|1.23||||0.105|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.59|0.96|0.105
91517324|NCT01972841|182908293|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.28|2.16|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.16|1.28|<0.001
91517325|NCT01972841|182908293|SUPERIORITY||Odds Ratio (OR)|1.45||||0.005|TWO_SIDED|95.0|1.12|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.87|1.12|0.005
91517326|NCT03317977|182908315|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
91517327|NCT00688636|182908318|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Fisher Exact|||||||.0005
91517328|NCT01572727|182908323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.82|1.68||||||||1.68|0.82|
91517329|NCT04053764|182908331|SUPERIORITY||Odds Ratio (OR)|1.94|||||TWO_SIDED|95.0|0.53|7.14||||||||7.14|0.53|
91517330|NCT04053764|182908333|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.23|2.31||||||||2.31|0.23|
91517331|NCT04053764|182908334|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.29|3.02||||||PCR Improvement||3.02|0.29|
91517332|NCT04053764|182908334|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.18|3.2||||||Stable PCR||3.20|0.18|
91517333|NCT04053764|182908335|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-5.53|4.65||||||From baseline to 3 months||4.65|-5.53|
91517334|NCT04053764|182908335|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-2.02|11.4||||||From baseline to 6 months||11.40|-2.02|
91517335|NCT04053764|182908335|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-3.58|11.68||||||From baseline to 9 months||11.68|-3.58|
91517336|NCT04053764|182908335|SUPERIORITY||Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|4.17|||TWO_SIDED|95.0|-3.28|13.67||||||From baseline to 12 months||13.67|-3.28|
91517337|NCT04053764|182908338|SUPERIORITY||Odds Ratio (OR)|0.32|||||TWO_SIDED|95.0|0.09|1.21||||||||1.21|0.09|
91517338|NCT02935062|182908343|SUPERIORITY|||||||0.001|||||||t-test, 1 sided|||||||0.001
91517339|NCT02935062|182908344|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|||||||0.011
91517340|NCT02890381|182908375|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|35.0|86.0||||||||86|35|
91517341|NCT02890381|182908375|OTHER||% placebo recipients with solicited AEs|100.0|||||TWO_SIDED|90.0|61.0|100.0||||||||100|61|
91517342|NCT02890381|182908376|OTHER||% vaccinees with unsolicited AEs|36.0|||||TWO_SIDED|90.0|14.0|65.0||||||||65|14|
91517343|NCT02890381|182908376|OTHER||% placebo with unsolicited AEs|50.0|||||TWO_SIDED|90.0|15.0|85.0||||||||85|15|
91517344|NCT02890381|182908381|SUPERIORITY|||||||0.64||||||Since the sample sizes are unequal, at the suggestion of the DSMB statistician, a 1-sided Fisher's exact test was used to test the hypothesis that the proportions of \>=4-fold rises were higher in the vaccinated group than in the placebo group.|Fisher Exact|||||||0.64
91517345|NCT02890381|182908382|SUPERIORITY|||||||0.73||||||The threshold for statistical significance is 0.05.|Log Rank|||||||0.73
91517346|NCT01483924|182908391|SUPERIORITY_OR_OTHER|||||||0.9048|TWO_SIDED||||||ANOVA|||The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group||||0.9048
91517347|NCT01483924|182908392|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.1975
91517348|NCT01483924|182908393|SUPERIORITY_OR_OTHER|||||||0.6349|TWO_SIDED||||||Kruskal-Wallis|||||||0.6349
91517349|NCT01483924|182908394|SUPERIORITY_OR_OTHER|||||||0.6212|TWO_SIDED||||||Kruskal-Wallis|||||||0.6212
91517350|NCT02195986|182908412|EQUIVALENCE|Bioequivalence was established for the primary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the primary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|-0.0062|||||TWO_SIDED|90.0|-0.1209|0.1084||||||The compound hypothesis to test was: H0: PT -PR \< -.20 or PT -PR \> .20 versus HA : -.20 ≤ PT -PR ≤ .20 Where PT = cure rate of test treatment, and PR = cure rate of reference treatment.||0.1084|-0.1209|
91517351|NCT02195986|182908413|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.3766|||<|0.0001|TWO_SIDED|95.0|0.2743|0.479|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4790|0.2743|<0.0001
91517352|NCT02195986|182908413|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.3542|||<|0.0001|TWO_SIDED|95.0|0.257|0.4514|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4514|0.2570|<0.0001
91517353|NCT02195986|182908414|EQUIVALENCE|Bioequivalence was established for the secondary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the secondary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|0.05|||||TWO_SIDED|90.0|-0.0687|0.1686||||||||0.1686|-0.0687|
91517354|NCT02195986|182908415|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.1387||||0.1092|TWO_SIDED|95.0|-0.028|0.3054|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.3054|-0.0280|0.1092
91517355|NCT02195986|182908415|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.1196||||0.1805|TWO_SIDED|95.0|-0.0491|0.2883|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.2883|-0.0491|0.1805
91517356|NCT00395876|182908461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6||||0.0002||95.0|18.4|54.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||54.8|18.4|0.0002
91517357|NCT00395876|182908462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.1385||95.0|-3.1|25.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||25.8|-3.1|0.1385
91517358|NCT00395876|182908463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0093||95.0|7.1|42.6||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||42.6|7.1|0.0093
91517359|NCT02270450|182908472|SUPERIORITY||Mean Difference (Net)|2.87|STANDARD_ERROR_OF_MEAN|4.3||0.5|TWO_SIDED|||||A p-value less than 0.05 is considered statistically significant.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|"A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of good days between patients assigned to surgery and patients assigned to non-surgical management."||||0.50
91580342|NCT00741390|183050888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.84|||<|0.001||95.0|6.8|10.84|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||10.84|6.80|<0.001
91580343|NCT00741390|183050888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.55||||0.003||95.0|3.63|8.55|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||8.55|3.63|0.003
91580344|NCT00741390|183050888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.46||95.0|-3.57|0.23|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||0.23|-3.57|0.460
91517360|NCT02270450|182908473|SUPERIORITY||Mean Difference (Net)|-1.09||||0.64|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.64
91517361|NCT02270450|182908474|SUPERIORITY||Odds Ratio (OR)|0.82||||0.6|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.||||0.60
91517362|NCT02270450|182908475|SUPERIORITY||Mean Difference (Net)|0.64||||0.47|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.47
91517363|NCT02270450|182908476|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.001
91517364|NCT02270450|182908476|SUPERIORITY||Mean Difference (Net)|-1.63||||0.008|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.008
91517365|NCT02270450|182908476|SUPERIORITY||Mean Difference (Net)|-1.31||||0.04|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.04
91517366|NCT02270450|182908476|SUPERIORITY||Mean Difference (Net)|-3.6||||0.01|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.01
91517367|NCT02270450|182908476|SUPERIORITY||Mean Difference (Net)|-1.9||||0.007|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.007
91580345|NCT00741390|183050889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.9||||0.017||95.0|1.14|4.9|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||4.90|1.14|0.017
91517368|NCT02270450|182908477|SUPERIORITY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.52
91517369|NCT02270450|182908478|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.09|||Regression, Cox|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.||1.09|0.45|0.12
91517370|NCT02081846|182908492|SUPERIORITY|||||||0.047|||||||Regression, Logistic|||||||0.047
91517371|NCT02081846|182908493|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
91517372|NCT02081846|182908494|SUPERIORITY|||||||0.82|||||||censored Poisson model|||||||0.82
91517373|NCT02081846|182908495|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
91517374|NCT02081846|182908496|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
91517375|NCT02081846|182908497|SUPERIORITY|||||||0.052|||||||Regression, Logistic|||||||0.052
91517376|NCT02081846|182908498|SUPERIORITY|||||||0.12|||||||Regression, Logistic|||||||0.12
91517377|NCT03265600|182908499|SUPERIORITY||Odds Ratio (OR)|2.91||||0.006|TWO_SIDED||||||Unadjusted bivariate logistic regression|||||||0.006
91517378|NCT03265600|182908500|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Cohen's d: -0.25||||||0.19
91517379|NCT03265600|182908501|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Cohen's d: -0.36||||||0.12
91517380|NCT03265600|182908502|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|Cohen's d: -0.34||||||0.08
91517381|NCT03265600|182908503|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.57||||||<0.001
91517382|NCT03265600|182908504|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|Cohen's d: 0.41||||||0.03
91517383|NCT03265600|182908505|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Cohen's d: 0.15||||||0.31
91517384|NCT03265600|182908506|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Cohen's d: 0.22||||||0.26
91517385|NCT03265600|182908507|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: -0.58||||||<0.001
91517386|NCT03265600|182908508|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.75||||||<0.001
91517387|NCT00535730|182908509|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio\[concomitant/nonconcomitant\] being \>0.67.||||||0.244||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to that in subjects who receive ZOSTAVAX™ nonconcomitantly||||0.244
91517388|NCT00535730|182908511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|t-test, 1 sided|The one-sided p-value for testing acceptability for GMFR is computed based on t-test. CI is computed based on the t distribution||The hypothesis was that ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23.||||<0.001
91517389|NCT00535730|182908512|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||"The hypothesis was that the GMT of the PnPs antibody response to serotype 3 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who~receive ZOSTAVAX™ nonconcomitantly."||||<0.001
91517390|NCT00535730|182908513|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 14 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
91517391|NCT00535730|182908514|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 19A at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
91517392|NCT00535730|182908515|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
91517393|NCT00936858|182908516|OTHER||6 month PFS probability|0.35|||||TWO_SIDED|||||||||We will declare the trial a success after observing 7 or more patients with PFS within 6 months. The study will have alpha = 0.092 and power =0.970, assuming a 6 month PFS probability of 0.12 for the null and a PFS probability of 0.35 as the alternative hypothesis.||||
91517394|NCT02522715|182908551|OTHER||||||<|0.01|||||||two-sided exact binomial test|||One-sample binomial test with null hypothesis that the percentage of participants with PSA response 1 is equal to 25%.||||<0.01
91517395|NCT01808313|182908559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.59|||<|0.001|TWO_SIDED|95.0|42.53|64.66|||t-test, 2 sided|||||64.66|42.53|<0.001
91517396|NCT01808313|182908560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.36|||<|0.001|TWO_SIDED|95.0|48.72|80.0|||t-test, 2 sided|||||80.00|48.72|<0.001
91517397|NCT01808313|182908562|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-rank test|||Week 12||||<0.001
91517398|NCT01808313|182908562|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon signed-rank test|||Week 24||||0.003
91517399|NCT01808313|182908563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.366|0.519|||Wilcoxon signed-rank test||Week 12|||0.519|0.366|<0.001
91517400|NCT01808313|182908563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.001|TWO_SIDED|95.0|0.303|0.453|||Wilcoxon signed-rank test||Week 24|||0.453|0.303|<0.001
91517401|NCT03086447|182908600|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agresti-Coull||All eyes (100%) in the Test group had acceptable VA throughout the study.|Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.||100|96.5|
91517402|NCT03086447|182908601|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens fit with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable lens fit at fitting (visit 1).|Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
91517403|NCT03086447|182908602|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens stability with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable stability at fitting.|Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
91517404|NCT03086447|182908603|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of absolute rotation with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Least square mean proportion|99.6|||||TWO_SIDED|95.0|97.5|99.9||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Linear mixed model with binomial dist.||Above 80% of eyes in the Test group had acceptable rotation.|Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||99.9|97.5|
91517405|NCT03086447|182908604|OTHER|It was deemed that a total of 135 subjects per each study group is sufficient to demonstrate no statistical difference in the CS incidence rate between the Test and Control groups with a minimum of 80% statistical power using the reference incidence rate of 0.005% with a correlation of 0.3 between eyes within subject.|Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.004|1.437||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Bayesian beta-binomial model|A 95% credible interval for the posterior estimate (Test over Control) was used to test no difference between the Test and Control groups.|odds ratio calculated as Test over Control|Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.||1.437|0.004|
91517406|NCT03086447|182908605|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|2.39|||TWO_SIDED|95.0|2.1|11.5|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||11.5|2.1|
91517407|NCT03086447|182908606|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|2.04|||TWO_SIDED|95.0|-7.2|0.9|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||0.9|-7.2|
91517408|NCT03086447|182908607|NON_INFERIORITY|A non-inferiority margin of 0.5 was used. This margin is based on a 10% difference in the distribution between the Test and Control groups.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.98|3.22|||Generalized LMM w/ binomial dist.||Odds ratio of Test over Control was calculated.|Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.||3.22|0.98|
91517409|NCT00435370|182908619|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||||||<0.05
91517410|NCT03387852|182908645|SUPERIORITY||Odds ratio|0.423|||=|0.0214|TWO_SIDED|95.0|0.203|0.88|||Regression, Logistic||SAR440340 300 mg vs. Placebo|Odds ratio, 95% confidence interval (CI), and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||0.88|0.203|=0.0214
91517411|NCT03387852|182908645|SUPERIORITY||Odds ratio|0.52|||=|0.0709|TWO_SIDED|95.0|0.256|1.057|||Regression, Logistic||SAR440340 + Dupilumab vs. Placebo|Odds ratio, 95% CI, and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||1.057|0.256|=0.0709
91517412|NCT00126438|182908697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.73||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.73|0.18|0.001
91517413|NCT00126438|182908697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.18|0.001
91517414|NCT00126438|182908697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.001|TWO_SIDED|95.0|0.17|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.17|0.001
91580346|NCT00741390|183050890|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.001
91580347|NCT00741390|183050890|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.002
91517415|NCT04414696|182908766|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Multivariable linear regression|||1.5|-3.3|
91517416|NCT04414696|182908767|SUPERIORITY||Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-23.5|14.5|||||Multivariable linear regression|||14.5|-23.5|
91517417|NCT04414696|182908768|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-1.9|9.5||||||||9.5|-1.9|
91517418|NCT04414696|182908769|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-18.9|21.5|||||Multivariable linear regression|||21.5|-18.9|
91517419|NCT04414696|182908770|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||Multivariable linear regression|||1.1|-3.7|
91517420|NCT04414696|182908771|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-7.7|4.2|||||Multivariable linear regression|||4.2|-7.7|
91517421|NCT04414696|182908772|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.2|2.1|||||Multivariable linear regression|||2.1|-1.2|
91517422|NCT04414696|182908773|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.1|||||Multivariable linear regression|||1.1|-1|
91517423|NCT04414696|182908774|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.4|1.2|||||Multivariable linear regression|||1.2|-3.4|
91517424|NCT04414696|182908775|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-4.9|1.3|||||Multivariable linear regression|||1.3|-4.9|
91517425|NCT00785291|182908796|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.054|TWO_SIDED|95.0|1.0|1.45||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.45|1.00|0.054
91517426|NCT00785291|182908796|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55|||<|0.0001|TWO_SIDED|95.0|1.28|1.87||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.87|1.28|<0.0001
91517427|NCT00785291|182908800|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.2|TWO_SIDED|95.0|0.92|1.47||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.47|0.92|0.20
91517428|NCT00785291|182908800|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.038|TWO_SIDED|95.0|1.01|1.61||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.61|1.01|0.038
91517429|NCT05183022|182908818|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
91517430|NCT02120027|182908853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.949|TWO_SIDED|95.0|0.64|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.64|0.949
91517431|NCT02120027|182908854|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.193|TWO_SIDED|95.0|0.88|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.88|0.193
91517432|NCT02120027|182908855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.872|TWO_SIDED|95.0|0.7|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.70|0.872
91517433|NCT02120027|182908856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.339||||0.272|TWO_SIDED|95.0|0.79|2.26|||Cochran-Mantel-Haenszel|||||2.26|0.79|0.272
91580348|NCT00741390|183050890|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.761
91517434|NCT02120027|182908857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.567|TWO_SIDED|95.0|0.73|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.73|0.567
91517435|NCT04162769|182908886|SUPERIORITY||Least square mean difference|-10.28|STANDARD_ERROR_OF_MEAN|6.605|=|0.1198|TWO_SIDED|95.0|-23.228|2.674|||ANCOVA|||Week 12||2.674|-23.228|=0.1198
91517436|NCT04162769|182908886|SUPERIORITY||Least square mean difference|-8.77|STANDARD_ERROR_OF_MEAN|6.515|=|0.1783|TWO_SIDED|95.0|-21.544|4.002|||ANCOVA|||Week 12||4.002|-21.544|=0.1783
91517437|NCT04162769|182908887|SUPERIORITY||Response Rate Difference|-0.2|STANDARD_ERROR_OF_MEAN|9.34|=|0.9826|TWO_SIDED|95.0|-18.52|18.11|||Cochran-Mantel-Haenszel|||Week 12||18.11|-18.52|=0.9826
91517438|NCT04162769|182908887|SUPERIORITY||Response Rate Difference|13.0|STANDARD_ERROR_OF_MEAN|9.78|=|0.1891|TWO_SIDED|95.0|-6.12|32.21|||Cochran-Mantel-Haenszel|||Week 12||32.21|-6.12|=0.1891
91517439|NCT04162769|182908888|SUPERIORITY||Response Rate Difference|2.2|STANDARD_ERROR_OF_MEAN|7.38|=|0.7694|TWO_SIDED|95.0|-12.29|16.64|||Cochran-Mantel-Haenszel|||Week 12||16.64|-12.29|=0.7694
91517440|NCT04162769|182908888|SUPERIORITY||Response Rate Difference|17.4|STANDARD_ERROR_OF_MEAN|8.47|=|0.045|TWO_SIDED|95.0|0.79|34.0|||Cochran-Mantel-Haenszel|||Week 12||34.00|0.79|=0.0450
91517441|NCT04162769|182908889|SUPERIORITY||Least square mean difference|-14.03|STANDARD_ERROR_OF_MEAN|7.295|=|0.0558|TWO_SIDED|95.0|-28.406|0.352|||Mixed Models Analysis|||Week 12||0.352|-28.406|=0.0558
91517442|NCT04162769|182908889|SUPERIORITY||Least square mean difference|-10.67|STANDARD_ERROR_OF_MEAN|7.134|=|0.1363|TWO_SIDED|95.0|-24.737|3.397|||Mixed Models Analysis|||Week 12||3.397|-24.737|=0.1363
91517443|NCT04162769|182908890|SUPERIORITY||Response Rate Difference|4.2|STANDARD_ERROR_OF_MEAN|11.33|=|0.7143|TWO_SIDED|95.0|-18.0|26.41|||Cochran-Mantel-Haenszel|||Week 12||26.41|-18.00|=0.7143
91517444|NCT04162769|182908890|SUPERIORITY||Response Rate Difference|5.1|STANDARD_ERROR_OF_MEAN|11.09|=|0.6488|TWO_SIDED|95.0|-16.62|26.87|||Cochran-Mantel-Haenszel|||Week 12||26.87|-16.62|=0.6488
91517445|NCT04162769|182908891|SUPERIORITY||Response Rate Difference|8.8|STANDARD_ERROR_OF_MEAN|10.22|=|0.3981|TWO_SIDED|95.0|-11.27|28.8|||Cochran-Mantel-Haenszel|||Week 12||28.80|-11.27|=0.3981
91517446|NCT04162769|182908891|SUPERIORITY||Response Rate Difference|15.2|STANDARD_ERROR_OF_MEAN|10.17|=|0.141|TWO_SIDED|95.0|-4.72|35.15|||Cochran-Mantel-Haenszel|||Week 12||35.15|-4.72|=0.1410
91517447|NCT04162769|182908892|SUPERIORITY||Response Rate Difference|8.4|STANDARD_ERROR_OF_MEAN|7.65|=|0.269|TWO_SIDED|95.0|-6.61|23.38|||Cochran-Mantel-Haenszel|||Week 12||23.38|-6.61|=0.2690
91517448|NCT04162769|182908892|SUPERIORITY||Response Rate Difference|4.3|STANDARD_ERROR_OF_MEAN|7.09|=|0.5428|TWO_SIDED|95.0|-9.56|18.25|||Cochran-Mantel-Haenszel|||Week 12||18.25|-9.56|=0.5428
91517449|NCT04162769|182908893|SUPERIORITY||Least square mean difference|-2.81|STANDARD_ERROR_OF_MEAN|7.721|=|0.7163|TWO_SIDED|95.0|-18.089|12.466|||Mixed Models Analysis|||Week 12||12.466|-18.089|=0.7163
91517450|NCT04162769|182908893|SUPERIORITY||Least square mean difference|-13.24|STANDARD_ERROR_OF_MEAN|7.602|=|0.084|TWO_SIDED|95.0|-28.284|1.805|||Mixed Models Analysis|||Week 12||1.805|-28.284|=0.0840
91517451|NCT00845663|182908971|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|101.33||||||90.0|92.84|110.58|||ANOVA|ANOVA for log-transformed values with treatment as factor has been used as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||110.58|92.84|
91517452|NCT00845663|182908972|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125% bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.7||||||90.0|89.06|107.19|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||107.19|89.06|
91517453|NCT00845663|182908973|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.54||||||90.0|87.33|108.94|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as a basis for calculation of estimated value and the confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||108.94|87.33|
91517454|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517455|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517456|NCT05585307|182909013|SUPERIORITY|||||||0.0013||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||0.0013
91517457|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517458|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517459|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517460|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91580349|NCT00741390|183050890|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.004
91517461|NCT05585307|182909013|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517462|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517463|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517464|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517465|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517466|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517467|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517468|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517469|NCT05585307|182909014|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
91517470|NCT01270347|182909052|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the LS mean difference 95% CI for relative change from Baseline to Day 28 in FEV1 percent predicted was \> -4%.|LSMean difference|1.86||||0.1481|TWO_SIDED|95.0|-0.66|4.39|||ANCOVA||Estimates were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).|||4.39|-0.66|0.1481
91517471|NCT01270347|182909053|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|4.968||||0.083|TWO_SIDED|95.0|-0.653|10.59|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), \& baseline as a covariate.|||10.590|-0.653|0.0830
91517472|NCT01270347|182909054|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|1.57||||0.0945|TWO_SIDED|95.0|-0.272|3.411|||ANCOVA||Estimates are determined from a repeated measures model with terms for treatment, visit, the interaction between treatment group and visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate.|||3.411|-0.272|0.0945
91517473|NCT01270347|182909057|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Pseudomonas Aeruginosa Sputum Density is \> -4%|LSMean difference|0.44||||0.053|TWO_SIDED|95.0|-0.01|0.88|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||0.88|-0.01|0.0530
91517474|NCT01270347|182909059|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Respiratory Domain of the CFQ-R is \> -4%|LSMean difference|3.19||||0.0463|TWO_SIDED|95.0|0.05|6.32|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline value.|||6.32|0.05|0.0463
91517475|NCT02085408|182909061|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.94|1.3|||Regression, Cox||Hazard ratio : clofarabine/(daunorubicin \& cytarabine)|||1.30|0.94|
91517476|NCT02085408|182909062|SUPERIORITY|||||||0.94|||||||Fisher Exact|||||||0.94
91517477|NCT02486328|182909086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91517478|NCT02486328|182909087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91517479|NCT02486328|182909088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
91517480|NCT02486328|182909089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91517481|NCT02486328|182909090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91517482|NCT02486328|182909091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
91517483|NCT02491671|182909203|SUPERIORITY||Risk Ratio (RR)|1.219||||0.171|TWO_SIDED|95.0|0.891|1.583|||Chi-squared|||||1.583|0.891|0.171
91517484|NCT02491671|182909204|SUPERIORITY||z|0.288|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Wilcoxon rank-sum (Mann-Whitney) test Unadjusted variance 274999.00 Adjustment for ties --21069.78 Adjusted variance 253929.22 z = 0.288; Prob \> \|z\| = 0.7735"|||||>0.05
91517485|NCT02491671|182909205|SUPERIORITY||Risk Ratio (RR)|1.351||||0.307|TWO_SIDED|95.0|0.657|1.879|||Chi-squared|||||1.879|0.657|0 .307
91517486|NCT02251990|182909208|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value was based on a one-sided asymptotic test for a binomial proportion. A one-sided p-value \<0.0125 was considered supportive of a conclusion that the true SVR12 is \>73%.|one-sided asymptotic test|||A one-sided Wald test was used to test the null hypothesis, which was that the SVR12 rate for the ITG was ≤ the historical reference rate of 73%. The historical reference SVR rate for treatment-naive genotype 1 predominantly Asian participants treated with pegylated interferon/ribavirin was derived from 2 studies (PMCID: PMC417, PMCID: PMC3644280) after adjusting for an expected improved safety profile related to an interferon-free regimen.||||<0.001
91517487|NCT02251990|182909209|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-10.6|9.6||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||9.6|-10.6|
91517488|NCT02251990|182909210|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-4.2|0.9||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||0.9|-4.2|
91517489|NCT01201057|182909256|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|||||||0.006
91517490|NCT01201057|182909257|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
91517491|NCT01201057|182909258|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||||||0.025
91517492|NCT00683644|182909264|OTHER|The observed power in THQ for zinc is 0.16, and that for placebo is 0.06.|||||>|0.05||||||Threshold for significance is 0.05|Chi-squared|||||||>0.05
91517493|NCT00683644|182909265|OTHER|||||||0.89||||||Threshold for significance is 0.05|paired t test|||||||0.89
91517494|NCT00683644|182909265|OTHER|||||||0.36||||||Threshold for significance is 0.05|paired t test|||||||0.36
91517495|NCT00683644|182909266|OTHER|||||||0.64||||||Threshold for significance is 0.05|paired t test|||||||0.64
91517496|NCT00683644|182909266|OTHER|||||||0.93||||||Threshold for significance is 0.05|paired t test|||||||0.93
91517497|NCT03240692|182909274|OTHER|||||||0.036||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and frontal Default Mode Network (fDMN) functional connectivity||||0.036
91517498|NCT03240692|182909274|OTHER|||||||0.008||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and medial Default Mode Network (mDMN) functional connectivity||||0.008
91517499|NCT03240692|182909274|OTHER|||||||0.06||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and left Default Mode Network (lDMN) functional connectivity.||||0.06
91517500|NCT03240692|182909274|OTHER|||||||0.017||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and right Default Mode Network (rDMN) functional connectivity.||||0.017
91517501|NCT00622167|182909296|SUPERIORITY_OR_OTHER|||||||0||0.0|||||Not done|||Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.||||0
91517502|NCT03858803|182909297|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517503|NCT03858803|182909298|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517504|NCT03858803|182909299|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517505|NCT03858803|182909300|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517506|NCT03858803|182909301|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517507|NCT03858803|182909302|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517508|NCT03858803|182909303|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517509|NCT03858803|182909304|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517510|NCT03858803|182909305|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517511|NCT03858803|182909306|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517512|NCT03858803|182909307|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
91517513|NCT02194621|182909308|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
91517514|NCT02194621|182909309|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
91517515|NCT02194621|182909310|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
91517516|NCT02194621|182909311|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.002
91517517|NCT00809757|182909327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-1.412|0.342|||||Difference is Placebo MDI minus Levalbuterol UDV|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.342|-1.412|
91517518|NCT00809757|182909327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-1.714|0.335|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations||0.335|-1.714|
91517519|NCT00809757|182909327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-1.08|0.771|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.771|-1.080|
91517520|NCT00234065|182909356|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin.|Hazard Ratio, log|0.743||||0.0357|TWO_SIDED|95.0|0.564|0.981||The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O'Brien-Fleming method.|Log Rank|||Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke||0.981|0.564|0.0357
91517521|NCT00234065|182909357|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.88||||0.4189|TWO_SIDED|95.0|0.645|1.2|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.200|0.645|0.4189
91517522|NCT00234065|182909358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.4582|TWO_SIDED|95.0|0.675|1.194|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.194|0.675|0.4582
91517523|NCT00234065|182909359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.072||||0.86|TWO_SIDED|95.0|0.497|2.313|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||2.313|0.497|0.8600
91517524|NCT00234065|182909360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799||||0.0437|TWO_SIDED|95.0|0.643|0.994|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.994|0.643|0.0437
91517525|NCT00234065|182909361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.458||||0.0004|TWO_SIDED|95.0|0.296|0.711|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.711|0.296|0.0004
91517526|NCT02621931|182909429|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.46|-1.15||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the statistical analysis plan (SAP).||-1.15|-2.46|<0.0001
91517527|NCT02621931|182909429|SUPERIORITY||LSM difference from placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.76|-1.45||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||-1.45|-2.76|<0.0001
91517528|NCT02621931|182909431|SUPERIORITY||LSM difference from placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.48|-0.97||0.05 level of significance|ANCOVA|||||-0.97|-2.48|<0.0001
91580350|NCT00620282|183050893|SUPERIORITY_OR_OTHER||Least squares mean|7.43||||0.0549||95.0|-0.164|15.025||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||15.025|-0.164|0.0549
91517529|NCT02621931|182909431|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.61|-1.09||0.05 level of significance|ANCOVA|||||-1.09|-2.61|<0.0001
91517530|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/placebo/placebo to Placebo||||<0.0001
91517531|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/225/225 to Placebo||||<0.0001
91517532|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
91517533|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
91517534|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
91517535|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
91517536|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
91517537|NCT02621931|182909432|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
91517538|NCT02621931|182909433|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91517539|NCT02621931|182909433|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91517540|NCT02621931|182909434|SUPERIORITY||LSM difference from placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.95|-1.73||0.05 level of significance|ANCOVA|||||-1.73|-2.95|<0.0001
91517541|NCT02621931|182909435|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91517542|NCT02621931|182909435|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91517543|NCT02621931|182909436|SUPERIORITY|||||||0.0004||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||0.0004
91517544|NCT02621931|182909436|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
91517545|NCT00920426|182909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||<|0.001|TWO_SIDED|95.0|-2.547|-1.632||Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.632|-2.547|<0.001
91517546|NCT00920426|182909470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.804|||<|0.001|TWO_SIDED|95.0|-2.173|-1.436||ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.436|-2.173|<0.001
91517547|NCT00920426|182909471|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
91517548|NCT01466985|182909481|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|Least squares (LS) mean difference|-1.37|||<|0.001||90.0|-1.6|-1.02|||ANCOVA|||||-1.02|-1.60|<0.001
91517549|NCT01466985|182909481|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|LS mean difference|-1.26|||<|0.001|TWO_SIDED|90.0|-1.51|-1.02|||ANCOVA|||||-1.02|-1.51|<0.001
91517550|NCT00886340|182909488|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||controlled for site, income, race/ethnicity|Mixed Models Analysis|||pilot test, used 20% of sample required for a full test of the hypothesis||||0.08
91517551|NCT02985866|182909492|SUPERIORITY|The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
91517552|NCT02985866|182909493|NON_INFERIORITY|The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
91580351|NCT00620282|183050893|SUPERIORITY_OR_OTHER||Least squares mean|2.08||||0.5681||95.0|-5.215|9.375||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||9.375|-5.215|0.5681
91517553|NCT02985866|182909494|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517554|NCT02985866|182909495|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517555|NCT02985866|182909496|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517556|NCT02985866|182909497|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517557|NCT02985866|182909498|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517558|NCT02985866|182909499|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517559|NCT02985866|182909500|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
91517560|NCT00686166|182909516|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Exact binomal test|||||||0.18
91517561|NCT00985725|182909519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0||||0.0009|TWO_SIDED|95.0|-12.7|-3.3|||ANCOVA|||||-3.3|-12.7|0.0009
91517562|NCT00985725|182909520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0465|TWO_SIDED|95.0|-3.7|0.0|||ANCOVA|||||0.0|-3.7|0.0465
91517563|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0181|TWO_SIDED|95.0|-9.4|-0.9|||ANCOVA|||Behavioral recognition index||-0.9|-9.4|0.0181
91517564|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2||||0.0204|TWO_SIDED|95.0|-7.7|-0.7|||ANCOVA|||Inhibit subscale||-0.7|-7.7|0.0204
91517565|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6||||0.009|TWO_SIDED|95.0|-9.8|-1.4|||ANCOVA|||Shift subscale||-1.4|-9.8|0.0090
91517566|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.0793|TWO_SIDED|95.0|-7.9|0.4|||ANCOVA|||Emotional control subscale||0.4|-7.9|0.0793
91517567|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.1014|TWO_SIDED|95.0|-7.0|0.6|||ANCOVA|||Self-monitor subscale||0.6|-7.0|0.1014
91517568|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0||||0.0002|TWO_SIDED|95.0|-13.7|-4.3|||ANCOVA|||Metacognition index||-4.3|-13.7|0.0002
91517569|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6||||0.0002|TWO_SIDED|95.0|-12.9|-4.2|||ANCOVA|||Initiate subscale||-4.2|-12.9|0.0002
91517570|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1||||0.0001|TWO_SIDED|95.0|-13.7|-4.5|||ANCOVA|||Working memory subscale||-4.5|-13.7|0.0001
91517571|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5||||0.001|TWO_SIDED|95.0|-11.9|-3.1|||ANCOVA|||Plan/Organize subscale||-3.1|-11.9|0.0010
91517572|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0357|TWO_SIDED|95.0|-9.4|-0.3|||ANCOVA|||Task monitor subscale||-0.3|-9.4|0.0357
91517573|NCT00985725|182909521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.0012|TWO_SIDED|95.0|-11.1|-2.8|||ANCOVA|||Organization of materials subscale||-2.8|-11.1|0.0012
91517574|NCT00985725|182909526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.1731|TWO_SIDED|95.0|-10.9|2.0|||ANCOVA|||||2.0|-10.9|0.1731
91517575|NCT00993655|182909534|SUPERIORITY|||||||0.065|||||||Cochran-Mantel-Haenszel|adjusting for stratification factors at randomization||Assume that the 9-month PD rate in IV arm (Arm 1) will be 40% (based on experience with data from NCIC CTG OV.16 and that of NCRI UK). The target sample size of 200 will enable the detection of a 19% difference between Arms 1 and 3 in 9 month progression disease rate post randomization with 80% power at two-sided 0.05 level.||||0.065
91517576|NCT00993655|182909535|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.27|TWO_SIDED|95.0|0.85|1.75|||Log Rank|Adjusting for stratification factors at randomization||||1.75|0.85|0.27
91517577|NCT00993655|182909536|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.4|TWO_SIDED|95.0|0.74|2.13|||Log Rank|Adjusting for stratification factors at randomization||||2.13|0.74|0.40
91517578|NCT02314624|182909537|SUPERIORITY|||||||0.734||||||Analyses were performed on each subscale individually. This is the p-value for the Depression subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.734
91517579|NCT02314624|182909537|SUPERIORITY|||||||0.27||||||Analyses were performed on each subscale individually. This is the p-value for the Anxiety subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.27
91517580|NCT02314624|182909537|SUPERIORITY|||||||0.75||||||Analyses were performed on each subscale individually. This is the p-value for the Stress subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.75
91517581|NCT02314624|182909537|SUPERIORITY|||||||0.812||||||Analyses were performed on each subscale individually. This is the p-value for the Suicide subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.812
91517582|NCT02314624|182909538|SUPERIORITY|||||||0.036|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.036
91517583|NCT02314624|182909539|SUPERIORITY|||||||0.664|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.664
91517584|NCT02314624|182909540|SUPERIORITY|||||||0.764|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.764
91517585|NCT02314624|182909541|SUPERIORITY|||||||0.44|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.440
91517586|NCT02314624|182909542|SUPERIORITY|||||||0.09|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.09
91517587|NCT02314624|182909543|SUPERIORITY|||||||0.19|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.19
91517588|NCT02314624|182909544|SUPERIORITY|||||||0.15|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.15
91517589|NCT02314624|182909545|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
91517590|NCT02314624|182909546|SUPERIORITY|||||||0.14|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.14
91517591|NCT02314624|182909547|SUPERIORITY|||||||0.22|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.22
91580352|NCT00620282|183050893|SUPERIORITY_OR_OTHER||Least squares mean|5.35||||0.1668||95.0|-2.323|13.024||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||13.024|-2.323|0.1668
91517592|NCT02314624|182909548|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
91517593|NCT02314624|182909549|SUPERIORITY|||||||0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.001
91517594|NCT02314624|182909550|SUPERIORITY|||||||0.99|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.99
91517595|NCT03912259|182909556|SUPERIORITY||Difference in Percentage|22.0|||<|0.0001|TWO_SIDED|95.0|11.37|32.65||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|P-value was derived by the Cochran-Mantel-Haenszel test stratified by baseline disease severity (IGA=3 vs. IGA=4).||||32.65|11.37|<.0001
91517596|NCT02131272|182909588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered fulfilled if the upper bound of the two-sided 95% confidence interval for the difference between detemir and NPH was below or equal to 0.4%. The sample size was set to ensure 80% power for the full analysis set (FAS). However, efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.|Least squares mean difference|0.17||||0.3075|TWO_SIDED|95.0|-0.74|1.09||p value is reported for 1 sided test|Mixed Models Analysis|||HbA1c measurements were analysed with a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.||1.09|-0.74|0.3075
91517597|NCT00464815|182909601|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|7.87|||||TWO_SIDED|95.0|1.63|14.87||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.87|1.63|
91517598|NCT00464815|182909601|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate Difference|0.67|||||TWO_SIDED|95.0|-1.65|4.18||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||4.18|-1.65|
91517599|NCT00464815|182909601|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|8.9|||||TWO_SIDED|95.0|4.78|14.14||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.14|4.78|
91517600|NCT00464815|182909601|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|15.22|||||TWO_SIDED|95.0|9.89|21.37||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||21.37|9.89|
91517601|NCT00464815|182909602|NON_INFERIORITY|Criterion for non-inferiority: the upper limit (UL) of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to (≤) the pre-defined clinical limit of 3.0.|Risk Ratio (RR)|4.02||||0.1456|TWO_SIDED|95.0|0.68|24.6|||Chi-squared|||To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.||24.6|0.68|0.1456
91517602|NCT00483184|182909636|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||ANOVA|||Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.||||0.404
91517603|NCT01992380|182909638|OTHER||ICC|0.971|||||TWO_SIDED|95.0|0.935|0.988|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.988|0.935|
91580353|NCT00620282|183050894|SUPERIORITY_OR_OTHER||Least squares mean|4.499||||0.2648||95.0|-3.535|12.534||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||12.534|-3.535|0.2648
91517604|NCT01992380|182909639|OTHER||ICC|0.968|||||TWO_SIDED|95.0|0.926|0.986|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.986|0.926|
91517605|NCT02071173|182909642|SUPERIORITY|Single group test comparison to a performance goal of 87%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.5|||||ONE_SIDED|97.5|97.0|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate \> 87%|||97.0|
91517606|NCT02071173|182909643|SUPERIORITY|Single group test comparison to a performance goal of 85%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|96.5|||||ONE_SIDED|95.0|93.8|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate \> 85%|||93.8|
91517607|NCT02071173|182909644|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|94.0|||||ONE_SIDED|97.5|92.0|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||92.0|
91517608|NCT02071173|182909645|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|91.1|||||ONE_SIDED|97.5|88.2|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||88.2|
91517609|NCT02071173|182909646|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.2|||||ONE_SIDED|95.0|97.5|||||||Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate \> 93%|||97.5|
91517610|NCT02071173|182909647|SUPERIORITY|Single group test comparison to a performance goal of 94%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|99.3|||||ONE_SIDED|95.0|98.8|||||||Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate \> 94%|||98.8|
91517611|NCT02071173|182909648|SUPERIORITY|Single group test comparison to a performance goal of 1.5 Volts. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|0.56|||||ONE_SIDED|95.0||0.58||||||Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT \< 1.5 Volts||0.58||
91517612|NCT02071173|182909649|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|17.4|||||ONE_SIDED|95.0|16.7|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||16.7|
91517613|NCT02071173|182909650|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|16.1|||||ONE_SIDED|97.5|15.1|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||15.1|
91517614|NCT02071173|182909651|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|776.0|||||ONE_SIDED|97.5|753.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||753|
91517615|NCT02071173|182909652|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|805.0|||||ONE_SIDED|97.5|763.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||763|
91517616|NCT02071173|182909653|SUPERIORITY|Single group test comparison to a performance goal of 4.5 seconds. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|3.14|||||ONE_SIDED|95.0||3.2||||||Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time \< 4.5 seconds||3.20||
91517617|NCT02071173|182909654|SUPERIORITY|Single group test comparison to a performance goal of 5 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|18.3|||||ONE_SIDED|95.0|6.2|||||||Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude \> 5 mV|||6.2|
91517618|NCT02071173|182909655|OTHER|Two one-sided tests (TOST) were performed.|Mean|468.0|||||TWO_SIDED|90.0|463.0|472.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||472|463|
91517619|NCT02071173|182909656|OTHER|Two one-sided tests (TOST) were performed.|Mean|702.0|||||TWO_SIDED|90.0|659.0|744.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||744|659|
91517620|NCT02071173|182909657|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Percent|99.5|||||ONE_SIDED|95.0|98.4|||||||Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion \> 93%|||98.4|
91517621|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-3.0|2.2|||Mixed Models Analysis|||||2.2|-3.0|
91517622|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||||2.9|-2.1|
91517623|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-1.4|5.7|||Mixed Models Analysis|||||5.7|-1.4|
91517624|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-6.2|0.9|||Mixed Models Analysis|||||0.9|-6.2|
91517625|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-1.3|5.8|||Mixed Models Analysis|||||5.8|-1.3|
91517626|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-0.7|6.9|||Mixed Models Analysis|||||6.9|-0.7|
91517627|NCT00515502|182909668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||||9.7|-0.1|
91517628|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.844|||TWO_SIDED|95.0|-2.47|0.92|||Mixed Models Analysis|||||0.92|-2.47|
91517629|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.798|||TWO_SIDED|95.0|-0.57|2.64|||Mixed Models Analysis|||||2.64|-0.57|
91517630|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_ERROR_OF_MEAN|1.151|||TWO_SIDED|95.0|-0.35|4.26|||Mixed Models Analysis|||||4.26|-0.35|
91517631|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.193|||TWO_SIDED|95.0|-4.11|0.67|||Mixed Models Analysis|||||0.67|-4.11|
91517632|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-1.44|3.33|||Mixed Models Analysis|||||3.33|-1.44|
91517633|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.257|||TWO_SIDED|95.0|0.24|5.28|||Mixed Models Analysis|||||5.28|0.24|
91517634|NCT00515502|182909669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.34|7.02|||Mixed Models Analysis|||||7.02|0.34|
91517635|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|-5.0|3.4|||Mixed Models Analysis|||||3.4|-5.0|
91517636|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-7.6|0.6|||Mixed Models Analysis|||||0.6|-7.6|
91517637|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-2.2|8.7|||Mixed Models Analysis|||||8.7|-2.2|
91517638|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-4.7|7.2|||Mixed Models Analysis|||||7.2|-4.7|
91517639|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-7.7|3.6|||Mixed Models Analysis|||||3.6|-7.7|
91517640|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-11.2|1.6|||Mixed Models Analysis|||||1.6|-11.2|
91517641|NCT00515502|182909670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.9|10.0|||Mixed Models Analysis|||||10.0|-5.9|
91517642|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.902|||TWO_SIDED|95.0|-6.23|1.39|||Mixed Models Analysis|||||1.39|-6.23|
91517643|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.834|||TWO_SIDED|95.0|-5.56|1.79|||Mixed Models Analysis|||||1.79|-5.56|
91517644|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.474|||TWO_SIDED|95.0|-3.82|6.07|||Mixed Models Analysis|||||6.07|-3.82|
91517645|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|2.697|||TWO_SIDED|95.0|-5.07|5.69|||Mixed Models Analysis|||||5.69|-5.07|
91517646|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-7.84|2.38|||Mixed Models Analysis|||||2.38|-7.84|
91517647|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.898|||TWO_SIDED|95.0|-7.97|3.59|||Mixed Models Analysis|||||3.59|-7.97|
91517648|NCT00515502|182909671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.618|||TWO_SIDED|95.0|-6.39|8.02|||Mixed Models Analysis|||||8.02|-6.39|
91517649|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-5.1|0.2|||Mixed Models Analysis|||||0.2|-5.1|
91517650|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-4.6|0.4|||Mixed Models Analysis|||||0.4|-4.6|
91517651|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.0|6.6|||Mixed Models Analysis|||||6.6|-0.0|
91517652|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-5.9|1.2|||Mixed Models Analysis|||||1.2|-5.9|
91517653|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|95.0|-3.5|3.3|||Mixed Models Analysis|||||3.3|-3.5|
91517654|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-3.5|4.1|||Mixed Models Analysis|||||4.1|-3.5|
91517655|NCT00515502|182909672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|1.0|10.4|||Mixed Models Analysis|||||10.4|1.0|
91517656|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-5.08|-0.87|||Mixed Models Analysis|||||-0.87|-5.08|
91517657|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-3.53|0.5|||Mixed Models Analysis|||||0.50|-3.53|
91517658|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.335|||TWO_SIDED|95.0|-0.46|4.88|||Mixed Models Analysis|||||4.88|-0.46|
91517659|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.409|||TWO_SIDED|95.0|-6.13|-0.5|||Mixed Models Analysis|||||-0.50|-6.13|
91517660|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|1.366|||TWO_SIDED|95.0|-2.38|3.07|||Mixed Models Analysis|||||3.07|-2.38|
91517661|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.514|||TWO_SIDED|95.0|-1.22|4.82|||Mixed Models Analysis|||||4.82|-1.22|
91517662|NCT00515502|182909673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|1.867|||TWO_SIDED|95.0|1.81|9.25|||Mixed Models Analysis|||||9.25|1.81|
91517663|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|3.256|||TWO_SIDED|95.0|-9.82|3.21|||Mixed Models Analysis|||||3.21|-9.82|
91517664|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|3.193|||TWO_SIDED|95.0|-4.7|8.09|||Mixed Models Analysis|||||8.09|-4.70|
91517665|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|4.268|||TWO_SIDED|95.0|-10.06|6.98|||Mixed Models Analysis|||||6.98|-10.06|
91517666|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17|STANDARD_ERROR_OF_MEAN|4.347|||TWO_SIDED|95.0|-13.84|3.5|||Mixed Models Analysis|||||3.50|-13.84|
91517667|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|4.264|||TWO_SIDED|95.0|-6.65|10.37|||Mixed Models Analysis|||||10.37|-6.65|
91517668|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-2.35|16.08|||Mixed Models Analysis|||||16.08|-2.35|
91517669|NCT00515502|182909674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.63|STANDARD_ERROR_OF_MEAN|5.634|||TWO_SIDED|95.0|-7.59|14.85|||Mixed Models Analysis|||||14.85|-7.59|
91517670|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.298|STANDARD_ERROR_OF_MEAN|2.3297|||TWO_SIDED|95.0|-4.961|4.365|||Mixed Models Analysis|||||4.365|-4.961|
91517671|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.066|STANDARD_ERROR_OF_MEAN|2.2776|||TWO_SIDED|95.0|-3.495|5.627|||Mixed Models Analysis|||||5.627|-3.495|
91517672|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.062|STANDARD_ERROR_OF_MEAN|3.0952|||TWO_SIDED|95.0|-8.247|4.122|||Mixed Models Analysis|||||4.122|-8.247|
91517673|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.362|STANDARD_ERROR_OF_MEAN|3.1891|||TWO_SIDED|95.0|-6.003|6.726|||Mixed Models Analysis|||||6.726|-6.003|
91517674|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|3.1121|||TWO_SIDED|95.0|-6.873|5.554|||Mixed Models Analysis|||||5.554|-6.873|
91517675|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.704|STANDARD_ERROR_OF_MEAN|3.3916|||TWO_SIDED|95.0|-6.064|7.473|||Mixed Models Analysis|||||7.473|-6.064|
91517676|NCT00515502|182909675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.424|STANDARD_ERROR_OF_MEAN|4.2233|||TWO_SIDED|95.0|-10.84|5.993|||Mixed Models Analysis|||||5.993|-10.84|
91517677|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.542|||TWO_SIDED|95.0|-4.98|5.15|||Mixed Models Analysis|||||5.15|-4.98|
91517678|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|2.507|||TWO_SIDED|95.0|-3.65|6.34|||Mixed Models Analysis|||||6.34|-3.65|
91517679|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|3.182|||TWO_SIDED|95.0|-7.49|5.19|||Mixed Models Analysis|||||5.19|-7.49|
91517680|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|3.296|||TWO_SIDED|95.0|-6.89|6.24|||Mixed Models Analysis|||||6.24|-6.89|
91517681|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|3.279|||TWO_SIDED|95.0|-6.13|6.94|||Mixed Models Analysis|||||6.94|-6.13|
91517682|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-5.34|8.67|||Mixed Models Analysis|||||8.67|-5.34|
91517683|NCT00515502|182909676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-8.97|7.32|||Mixed Models Analysis|||||7.32|-8.97|
91517684|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.464|STANDARD_ERROR_OF_MEAN|1.9766|||TWO_SIDED|95.0|-2.492|5.419|||Mixed Models Analysis|||||5.419|-2.492|
91517685|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|1.9457|||TWO_SIDED|95.0|-3.647|4.144|||Mixed Models Analysis|||||4.144|-3.647|
91517686|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.645|STANDARD_ERROR_OF_MEAN|2.5254|||TWO_SIDED|95.0|-7.687|2.396|||Mixed Models Analysis|||||2.396|-7.687|
91517687|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.585|STANDARD_ERROR_OF_MEAN|2.6352|||TWO_SIDED|95.0|-2.671|7.84|||Mixed Models Analysis|||||7.840|-2.671|
91517688|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.121|STANDARD_ERROR_OF_MEAN|2.5993|||TWO_SIDED|95.0|-6.308|4.067|||Mixed Models Analysis|||||4.067|-6.308|
91517689|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.336|STANDARD_ERROR_OF_MEAN|2.8164|||TWO_SIDED|95.0|-7.952|3.28|||Mixed Models Analysis|||||3.280|-7.952|
91517690|NCT00515502|182909677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.3802|||TWO_SIDED|95.0|-11.96|1.504|||Mixed Models Analysis|||||1.504|-11.96|
91517691|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|95.0|-9.7|-0.7|||Mixed Models Analysis|||||-0.7|-9.7|
91517692|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-8.9|-0.3|||Mixed Models Analysis|||||-0.3|-8.9|
91517693|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-13.5|-1.8|||Mixed Models Analysis|||||-1.8|-13.5|
91517694|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-11.8|1.1|||Mixed Models Analysis|||||1.1|-11.8|
91517695|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-6.1|6.4|||Mixed Models Analysis|||||6.4|-6.1|
91517696|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-6.1|7.5|||Mixed Models Analysis|||||7.5|-6.1|
91517697|NCT00515502|182909678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-10.9|6.2|||Mixed Models Analysis|||||6.2|-10.9|
91517698|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.6|0.0|||Mixed Models Analysis|||||0.0|-3.6|
91517699|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.0|1.4|||Mixed Models Analysis|||||1.4|-2.0|
91517700|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-3.9|0.8|||Mixed Models Analysis|||||0.8|-3.9|
91517701|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||||1.6|-3.6|
91517702|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|-3.3|1.7|||Mixed Models Analysis|||||1.7|-3.3|
91517703|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-2.0|3.4|||Mixed Models Analysis|||||3.4|-2.0|
91517704|NCT00515502|182909679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-4.1|2.9|||Mixed Models Analysis|||||2.9|-4.1|
91517705|NCT03252587|182909700|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0006|TWO_SIDED|95.0|1.5|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.5|0.0006
91517706|NCT03252587|182909700|SUPERIORITY||Odds Ratio (OR)|1.9||||0.021|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.4|1.0|0.0210
91517707|NCT03252587|182909700|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0781|TWO_SIDED|95.0|0.8|2.9|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||2.9|0.8|0.0781
91517708|NCT03252587|182909701|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0011|TWO_SIDED|95.0|1.4|4.8|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||4.8|1.4|0.0011
91517709|NCT03252587|182909701|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0434|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.1|0.9|0.0434
91517710|NCT03252587|182909701|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0439|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.1|0.9|0.0439
91517711|NCT03252587|182909702|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0012|TWO_SIDED|95.0|1.4|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.4|0.0012
91517712|NCT03252587|182909702|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0795|TWO_SIDED|95.0|0.8|3.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.0|0.8|0.0795
91517713|NCT03252587|182909702|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0673|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.2|0.9|0.0673
91517714|NCT03252587|182909703|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0002|TWO_SIDED|95.0|1.9|8.5|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||8.5|1.9|0.0002
91517715|NCT03252587|182909703|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0371|TWO_SIDED|95.0|0.9|4.5|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||4.5|0.9|0.0371
91517716|NCT03252587|182909703|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0168|TWO_SIDED|95.0|1.1|5.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||5.1|1.1|0.0168
91517717|NCT03252587|182909704|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0006|TWO_SIDED|95.0|2.5|43.0|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||43.0|2.5|0.0006
91580354|NCT00620282|183050894|SUPERIORITY_OR_OTHER||Least squares mean|0.709||||0.8518||95.0|-6.904|8.322||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||8.322|-6.904|0.8518
91517718|NCT03252587|182909704|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0058|TWO_SIDED|95.0|1.5|22.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||22.0|1.5|0.0058
91517719|NCT03252587|182909704|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0009|TWO_SIDED|95.0|2.2|31.0|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||31.0|2.2|0.0009
91517720|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.04||0.0131|TWO_SIDED|95.0|-4.4|-0.3|||Longitudinal Repeated Measures|||Tender BMS-986165 3 mg vs Placebo||-0.3|-4.4|0.0131
91517721|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.4156|TWO_SIDED|95.0|-2.3|1.8|||Longitudinal Repeated Measures|||Tender BMS-986165 6 mg vs Placebo||1.8|-2.3|0.4156
91517722|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0151|TWO_SIDED|95.0|-4.5|-0.2|||Longitudinal Repeated Measures|||Tender BMS-986165 12 mg vs Placebo||-0.2|-4.5|0.0151
91517723|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0029|TWO_SIDED|95.0|-2.2|-0.4|||Longitudinal Repeated Measures|||Swollen BMS-986165 3 mg vs Placebo||-0.4|-2.2|0.0029
91517724|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.0516|TWO_SIDED|95.0|-1.6|0.2|||Longitudinal Repeated Measures|||Swollen BMS-986165 6 mg vs Placebo||0.2|-1.6|0.0516
91517725|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.48||0.0298|TWO_SIDED|95.0|-1.8|0.0|||Longitudinal Repeated Measures|||Swollen BMS-986165 12 mg vs Placebo||0.0|-1.8|0.0298
91517726|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.0|-0.5|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 3 mg vs Placebo||-0.5|-2.0|0.0010
91517727|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.0343|TWO_SIDED|95.0|-1.5|0.1|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 6 mg vs Placebo||0.1|-1.5|0.0343
91517728|NCT03252587|182909705|SUPERIORITY||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.005|TWO_SIDED|95.0|-1.9|-0.3|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 12 mg vs Placebo||-0.3|-1.9|0.0050
91517729|NCT05098054|182909747|OTHER||Geometric Least-squares mean(GLSM) Ratio|214.93|||||TWO_SIDED|90.0|103.47|446.45|||||"Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||446.45|103.47|
91517730|NCT05098054|182909747|OTHER||GLSM Ratio|145.42|||||TWO_SIDED|90.0|77.18|273.98|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||273.98|77.18|
91517731|NCT05098054|182909748|OTHER||GLSM Ratio|299.21|||||TWO_SIDED|90.0|111.75|801.17|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||801.17|111.75|
91517732|NCT05098054|182909748|OTHER||GLSM Ratio|130.25|||||TWO_SIDED|90.0|77.02|220.26|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||220.26|77.02|
91517733|NCT05098054|182909749|OTHER||GLSM Ratio|316.27|||||TWO_SIDED|90.0|117.68|849.97|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||849.97|117.68|
91517734|NCT05098054|182909749|OTHER||GLSM Ratio|135.26|||||TWO_SIDED|90.0|91.22|200.57|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||200.57|91.22|
91517735|NCT04149405|182909756|OTHER||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||||||<0.01
91517736|NCT04149405|182909757|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91517737|NCT04149405|182909758|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91517738|NCT04149405|182909759|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
91517739|NCT04124926|182909760|NON_INFERIORITY|The noninferiority of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in EE rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.3|||<|0.0001|TWO_SIDED|95.0|4.49|12.23||2-sided p-value.|Farrington and Manning test||The 2-sided 95% confidence interval (CI) of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||12.23|4.49|<0.0001
91517740|NCT04124926|182909761|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.7|||<|0.0001|TWO_SIDED|95.0|1.8|15.53||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||15.53|1.80|<0.0001
91517741|NCT04124926|182909761|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|7.2|||<|0.0001|TWO_SIDED|95.0|0.21|14.09||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||14.09|0.21|<0.0001
91517742|NCT04124926|182909761|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0136||||||2-sided p-value.|Farrington and Manning test|||||||0.0136
91517743|NCT04124926|182909761|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0436||||||2-sided p-value.|Farrington and Manning test|||||||0.0436
91517744|NCT04124926|182909762|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.7|||||TWO_SIDED|95.0|-1.6|7.03|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between vonoprazan 20 mg and lansoprazole 30 mg was calculated from Welch's t-test.|||7.03|-1.60|
91517745|NCT04124926|182909763|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|17.6||||0.0008|TWO_SIDED|95.0|7.44|27.43||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.43|7.44|0.0008
91517746|NCT04124926|182909764|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|2.3||||0.4392|TWO_SIDED|95.0|-3.5|8.04||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in sustained resolution rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||8.04|-3.50|0.4392
91517747|NCT04124926|182909765|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|19.6|||<|0.0001|TWO_SIDED|95.0|11.84|27.58||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.58|11.84|<0.0001
91517748|NCT04124926|182909766|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|6.1||||0.0348|TWO_SIDED|95.0|0.53|11.6||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||11.60|0.53|0.0348
91517749|NCT04124926|182909767|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|15.7||||0.0196|TWO_SIDED|95.0|2.5|28.44||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||28.44|2.50|0.0196
91517750|NCT04124926|182909767|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|13.3||||0.049|TWO_SIDED|95.0|0.02|26.14||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||26.14|0.02|0.0490
91517751|NCT04124926|182909768|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.0|||||TWO_SIDED|95.0|-2.63|6.72|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.72|-2.63|
91517752|NCT04124926|182909768|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.3|||||TWO_SIDED|95.0|-2.27|6.84|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.84|-2.27|
91517753|NCT02167074|182909776|OTHER|The chi-square test (with Yates' correction when appropriate) or the Fisher exact test was used to compare the two needle types|||||<|0.05|||||||Chi-squared|||||||<0.05
91517754|NCT04009291|182909791|SUPERIORITY||||||=|0.2635|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.2635
91517755|NCT04009291|182909791|SUPERIORITY||||||=|0.6999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.6999
91517756|NCT04009291|182909791|SUPERIORITY||||||=|0.1394|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1394
91517757|NCT04009291|182909792|SUPERIORITY||||||=|0.1281|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1281
91517758|NCT04009291|182909792|SUPERIORITY||||||>|0.9999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||> 0.9999
91517759|NCT04009291|182909792|SUPERIORITY||||||=|0.0604|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.0604
91517760|NCT00567242|182909806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2801|STANDARD_ERROR_OF_MEAN|0.1077|<|0.05|ONE_SIDED|95.0||-0.0709|||t-test, 1 sided|||"H1: The Intention Group will show a significant rightward shift in lateral frontal laterality from pre-treatment to post-treatment.~H0: The Intention Group will show no shift in lateral frontal laterality from pre-treatment to post-treatment.~Since this is a repeated measures t test, the data are presented as the mean and standard deviation for for the post-treatment laterality index minus the pre-treatment laterality index."||-0.0709||<.05
91517761|NCT00567242|182909806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832|STANDARD_ERROR_OF_MEAN|0.2768|<|0.05|ONE_SIDED|95.0||0.3546|||t-test, 1 sided|||"H1: The Control Group will show a significant rightward shift in lateral frontal lateral indices from pre-treatment to post-treatment.~H0: The Control group will show no shift in lateral frontal laterality indices from pre-treatment to post-treatment.~Since the analysis to test these hypotheses is a repeated-measures t-test, the mean and standard deviation are given for post-treatment laterality index minus pre-treatment laterality index."||0.3546||<.05
91517762|NCT00567242|182909807|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|ONE_SIDED|95.0|-1.81||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||-1.81|<.05
91517763|NCT00567242|182909808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|ONE_SIDED|95.0|0.26||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||0.26|<.05
91517764|NCT01181050|182909818|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.9334||95.0|-0.54|0.5|||Mixed effect model repeated measures|||||0.50|-0.54|0.9334
91517765|NCT01181050|182909819|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.8293||95.0|-0.46|0.58|||Mixed effect model repeated measures|||||0.58|-0.46|0.8293
91517766|NCT01181050|182909820|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8867||95.0|-0.65|0.56|||Mixed effect model repeated measures|||||0.56|-0.65|0.8867
91517767|NCT03762135|182909849|SUPERIORITY|||||||0.044||||||This relates to the entirety of the 6-week period.|GEE Linear Regression|Generalized Estimation Equation Linear Regression||||||0.044
91517768|NCT02474927|182909922|OTHER|Descriptive (Pre-Post)||||||0.36|||||||Wilcoxon Signed Rank|||||||0.36
91517769|NCT02474927|182909923|OTHER|Descriptive (pre-post)||||||0.16|||||||Wilcoxon Signed Rank|||||||0.16
91517770|NCT00866840|182909933|OTHER|||||||||||||||||No objective responses were seen in the first phase and accrual was stopped.|No objective responses were seen in the first phase and accrual was stopped.|||
91517771|NCT02943408|182910098|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||.90
91517772|NCT02943408|182910099|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||.99
91517773|NCT02943408|182910100|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
91517774|NCT02943408|182910101|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||.85
91517775|NCT02943408|182910102|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
91517776|NCT02943408|182910103|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
91517777|NCT02943408|182910104|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||.50
91517778|NCT02943408|182910105|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
91517779|NCT02943408|182910106|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||.92
91517780|NCT02943408|182910107|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
91517781|NCT02943408|182910108|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||.35
91517782|NCT01106833|182910110|SUPERIORITY|||||||0.63||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.63
91517783|NCT01106833|182910110|SUPERIORITY|||||||0.44||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.44
91517784|NCT01106833|182910111|SUPERIORITY|||||||0.205||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.205
91517785|NCT01106833|182910112|SUPERIORITY|||||||0.141||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.141
91517786|NCT01106833|182910113|SUPERIORITY|||||||0.775||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.775
91517787|NCT01106833|182910114|SUPERIORITY|||||||0.396||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without relapse was treated as a competing risk||The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.396
91517788|NCT01106833|182910115|SUPERIORITY|||||||0.219||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without initiation of secondary therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.219
91517789|NCT01106833|182910116|SUPERIORITY|||||||0.706||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.706
91517790|NCT01106833|182910117|SUPERIORITY|||||||0.127||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.127
91517791|NCT01106833|182910117|SUPERIORITY|||||||0.562||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.562
91517792|NCT01106833|182910117|SUPERIORITY|||||||0.129||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.129
91517793|NCT01106833|182910118|SUPERIORITY|||||||0.586||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.586
91517794|NCT01106833|182910118|SUPERIORITY|||||||0.14||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.140
91517795|NCT01106833|182910119|SUPERIORITY|||||||0.582||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.582
91517796|NCT01106833|182910119|SUPERIORITY|||||||0.208||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.208
91517797|NCT01106833|182910119|SUPERIORITY|||||||0.431||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.431
91517798|NCT01106833|182910120|SUPERIORITY|||||||0.147||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.147
91517799|NCT01106833|182910120|SUPERIORITY|||||||0.863||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.863
91580355|NCT00620282|183050894|SUPERIORITY_OR_OTHER||Least squares mean|3.79||||0.3435||95.0|-4.194|11.774||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||11.774|-4.194|0.3435
91517800|NCT01106833|182910121|SUPERIORITY|||||||0.62||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.620
91517801|NCT01106833|182910121|SUPERIORITY|||||||0.258||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.258
91517802|NCT01106833|182910121|SUPERIORITY|||||||0.036||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.036
91517803|NCT01106833|182910121|SUPERIORITY|||||||0.369||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.369
91580356|NCT00620282|183050895|SUPERIORITY_OR_OTHER||Least squares mean|-0.536||||0.0023||95.0|-0.868|-0.203||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.203|-0.868|0.0023
91580357|NCT00620282|183050895|SUPERIORITY_OR_OTHER||Least squares mean|-0.077||||0.6207||95.0|-0.391|0.236||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||0.236|-0.391|0.6207
91580358|NCT00620282|183050895|SUPERIORITY_OR_OTHER||Least squares mean|-0.458||||0.0098||95.0|-0.8|-0.116||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.116|-0.8|0.0098
91580359|NCT00620282|183050896|SUPERIORITY_OR_OTHER||Least squares mean|-35.605||||||95.0|-46.797|-24.413||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-24.413|-46.797|
91580360|NCT00620282|183050896|SUPERIORITY_OR_OTHER||Least squares mean|-9.653||||0.0677||95.0|-20.041|0.736||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||0.736|-20.041|0.0677
91580361|NCT00620282|183050896|SUPERIORITY_OR_OTHER||Least squares mean|-25.952||||||95.0|-37.429|-14.475||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-14.475|-37.429|
91580362|NCT00620282|183050897|SUPERIORITY_OR_OTHER||Least squares mean|-11.871||||0.4121||95.0|-40.943|17.201||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||17.201|-40.943|0.4121
91580363|NCT00620282|183050897|SUPERIORITY_OR_OTHER||Least squares mean|3.815||||0.7622||95.0|-21.618|29.247||2-sided significance level of 5%|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||29.247|-21.618|0.7622
91580364|NCT00620282|183050897|SUPERIORITY_OR_OTHER||Least squares mean|-15.686||||0.2651||95.0|-43.838|12.466||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||12.466|-43.838|0.2651
91580365|NCT00620282|183050898|SUPERIORITY_OR_OTHER||Least squares mean|-1.528||||0.0268||95.0|-2.873|-0.184||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-0.184|-2.873|0.0268
91580366|NCT00620282|183050898|SUPERIORITY_OR_OTHER||Least squares mean|-2.859||||||95.0|-4.139|-1.579||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-1.579|-4.139|
91580367|NCT00620282|183050898|SUPERIORITY_OR_OTHER||Least squares mean|1.331||||0.0486||95.0|0.009|2.653||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||2.653|0.0090|0.0486
91580368|NCT00620282|183050899|SUPERIORITY_OR_OTHER||Least squares mean|-2.237||||0.7736||95.0|-17.829|13.354||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||13.354|-17.829|0.7736
91580369|NCT00620282|183050899|SUPERIORITY_OR_OTHER||Least squares mean|1.912||||0.7993||95.0|-13.168|16.991||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||16.991|-13.168|0.7993
91580370|NCT00620282|183050899|SUPERIORITY_OR_OTHER||Least squares mean|-4.149||||0.5903||95.0|-19.582|11.284||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||11.284|-19.582|0.5903
91580371|NCT00620282|183050900|SUPERIORITY_OR_OTHER||Least squares mean|3.702||||0.5583||95.0|-8.96|16.365||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||16.365|-8.96|0.5583
91580372|NCT00620282|183050900|SUPERIORITY_OR_OTHER||Least squares mean|2.773||||0.6517||95.0|-9.537|15.082||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||15.082|-9.537|0.6517
91580373|NCT00620282|183050900|SUPERIORITY_OR_OTHER||Least squares mean|0.929||||0.8822||95.0|-11.646|13.505||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||13.505|-11.646|0.8822
91580374|NCT00620282|183050901|SUPERIORITY_OR_OTHER||Least squares mean|-0.169||||0.9131||95.0|-3.273|2.935||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.935|-3.273|0.9131
91580375|NCT00620282|183050901|SUPERIORITY_OR_OTHER||Least squares mean|-0.723||||0.6362||95.0|-3.785|2.339||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.339|-3.785|0.6362
91580376|NCT00620282|183050901|SUPERIORITY_OR_OTHER||Least squares mean|0.554||||0.7283||95.0|-2.643|3.751||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||3.751|-2.643|0.7283
91580377|NCT00620282|183050902|SUPERIORITY_OR_OTHER||Least squares mean|-36.709||||0.0694||95.0|-76.467|3.048||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||3.048|-76.467|0.0694
91580378|NCT00620282|183050902|SUPERIORITY_OR_OTHER||Least squares mean|-3.786||||0.844||95.0|-42.373|34.801||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||34.801|-42.373|0.844
91580379|NCT00620282|183050902|SUPERIORITY_OR_OTHER||Least squares mean|-32.923||||0.0994||95.0|-72.353|6.507||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||6.507|-72.353|0.0994
91580380|NCT00620282|183050903|SUPERIORITY_OR_OTHER||Least squares mean|-0.42||||0.2282||95.0|-1.118|0.278||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.278|-1.118|0.2282
91580381|NCT00620282|183050903|SUPERIORITY_OR_OTHER||Least squares mean|-0.018||||0.9569||95.0|-0.697|0.661||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.661|-0.697|0.9569
91580382|NCT00620282|183050903|SUPERIORITY_OR_OTHER||Least squares mean|-0.402||||0.2465||95.0|-1.097|0.293||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.293|-1.097|0.2465
91580383|NCT02217475|183050907|SUPERIORITY||Odds Ratio (OR)|0.816||||0.5194|TWO_SIDED|95.0|0.439|1.516|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||1.516|0.439|0.5194
91580384|NCT02217475|183050908|SUPERIORITY||Odds Ratio (OR)|1.934||||0.0388|TWO_SIDED|95.0|1.035|3.614|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.614|1.035|0.0388
91580385|NCT02217475|183050909|SUPERIORITY||Odds Ratio (OR)|1.249||||0.592|TWO_SIDED|95.0|0.553|2.821|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.821|0.553|0.5920
91580386|NCT02217475|183050910|SUPERIORITY||Odds Ratio (OR)|1.396||||0.4941|TWO_SIDED|95.0|0.537|3.628|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.628|0.537|0.4941
91580387|NCT02217475|183050911|SUPERIORITY||Odds Ratio (OR)|1.142||||0.8434|TWO_SIDED|95.0|0.305|4.277|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.277|0.305|0.8434
91580388|NCT02217475|183050912|SUPERIORITY||Odds Ratio (OR)|2.201||||0.0234|TWO_SIDED|95.0|1.113|4.352|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.352|1.113|0.0234
91580389|NCT02217475|183050913|SUPERIORITY||Odds Ratio (OR)|1.154||||0.7474|TWO_SIDED|95.0|0.484|2.752|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.752|0.484|0.7474
91580390|NCT01237587|183050977|SUPERIORITY||LS mean change difference|-0.65|STANDARD_ERROR_OF_MEAN|0.33||0.052|TWO_SIDED|95.0|-1.3|0.0|||Repeated Measures|||||0.00|-1.30|0.052
91580391|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.36||0.059|TWO_SIDED|95.0|-1.4|0.03|||Mixed Models Analysis|||Worst Pain||0.03|-1.40|.059
91580392|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.319||0.059|TWO_SIDED|95.0|-1.24|0.02|||Mixed Models Analysis|||Least Pain||0.02|-1.24|0.059
91580393|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.365||0.165|TWO_SIDED|95.0|-1.23|0.21|||Mixed Models Analysis|||Pain Right Now||0.21|-1.23|.165
91580394|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.344||0.005|TWO_SIDED|95.0|-1.65|-0.3|||Mixed Models Analysis|||General Activity||-0.30|-1.65|0.005
91580395|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.128|TWO_SIDED|95.0|-1.25|0.16|||Mixed Models Analysis|||Mood||0.16|-1.25|.128
91580396|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.352||0.56|TWO_SIDED|95.0|-0.9|0.49|||Mixed Models Analysis|||Walking ability||0.49|-0.90|.560
91580397|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.371||0.448|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Normal Work||0.45|-1.01|0.448
91580398|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.312||0.011|TWO_SIDED|95.0|-1.42|-0.19|||Mixed Models Analysis|||Relations With Other||-0.19|-1.42|.011
91580399|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.454||0.443|TWO_SIDED|95.0|-1.25|0.55|||Mixed Models Analysis|||Sleep||0.55|-1.25|.443
91580400|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.338||0.39|TWO_SIDED|95.0|-0.96|0.38|||Mixed Models Analysis|||Enjoyment of Life||0.38|-0.96|.390
91580401|NCT01237587|183050978|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.424||0.16|TWO_SIDED|95.0|-1.44|0.24|||Mixed Models Analysis|||School Work||0.24|-1.44|.160
91580402|NCT01237587|183050980|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||.051
91580403|NCT01237587|183050981|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||.038
91580404|NCT01237587|183050982|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.669|TWO_SIDED|95.0|-9.1|5.86|||ANCOVA|||Average Pain Score||5.86|-9.10|.669
91580405|NCT01237587|183050982|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.169|TWO_SIDED|95.0|-14.32|2.53|||ANCOVA|||Worst Pain Score||2.53|-14.32|.169
91580406|NCT01237587|183050982|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.647|TWO_SIDED|95.0|-9.53|5.94|||ANCOVA|||Pain Score Right Now||5.94|-9.53|.647
91580407|NCT01237587|183050983|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.146|TWO_SIDED|95.0|-0.52|0.08|||ANCOVA|||||0.08|-0.52|.146
91580408|NCT01237587|183050984|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.927|TWO_SIDED|95.0|-0.23|0.21|||ANCOVA|||||0.21|-0.23|.927
91580409|NCT01237587|183050985|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.431|TWO_SIDED|95.0|-1.54|3.59|||ANCOVA|||||3.59|-1.54|.431
91580410|NCT01237587|183050986|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.529|TWO_SIDED|95.0|-1.95|3.79|||ANCOVA|||||3.79|-1.95|.529
91580411|NCT01237587|183050987|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.335|TWO_SIDED|95.0|-2.52|0.86|||ANCOVA|||||0.86|-2.52|.335
91580412|NCT01237587|183050988|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.955|TWO_SIDED|95.0|-1.59|1.68|||ANCOVA|||Physical Symptoms Score||1.68|-1.59|.955
91580413|NCT01237587|183050988|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.381|TWO_SIDED|95.0|-1.82|0.7|||ANCOVA|||Harm Avoidance||0.70|-1.82|.381
91580414|NCT01237587|183050988|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.486|TWO_SIDED|95.0|-1.66|0.79|||ANCOVA|||Social Anxiety||0.79|-1.66|.486
91580415|NCT01237587|183050988|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.7|TWO_SIDED|95.0|-1.17|0.79|||ANCOVA|||Separation/Panic||0.79|-1.17|.700
91580416|NCT01237587|183050988|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.54|TWO_SIDED|95.0|-5.12|2.69|||ANCOVA|||Total Score||2.69|-5.12|.540
91580417|NCT01139580|183050998|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
91580418|NCT01139580|183051001|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
91580419|NCT01285609|183051004|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.907||||0.2517|TWO_SIDED|95.0|0.767|1.072|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.072|0.767|0.2517
91580420|NCT01285609|183051005|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.917||||0.2421|TWO_SIDED|95.0|0.792|1.061||p-value based on stratified 2-sided log-rank test|Log Rank||Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.061|0.792|0.2421
91580421|NCT01285609|183051006|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.869||||0.0678|TWO_SIDED|95.0|0.749|1.009|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.009|0.749|0.0678
91580422|NCT01142115|183051007|NON_INFERIORITY_OR_EQUIVALENCE|The estimated difference VAS(Monza) minus VAS(SpeediCath)(i.e. the upper confidence limit) shall be less than 1cm to demonstrate non-inferiority.|Mean Difference (Final Values)|1.052||||0.0018|TWO_SIDED|95.0|0.412|1.692|||Mixed Models Analysis|||||1.692|0.412|0.0018
91580423|NCT01142115|183051008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.805|||<|0.0001|TWO_SIDED|95.0|2.604|12.939|||Regression, Logistic|||||12.939|2.604|<0.0001
91580424|NCT01142115|183051009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.616|TWO_SIDED|95.0|0.382|1.767|||Proportional odds regression model|||||1.767|0.382|0.6160
91580425|NCT01142115|183051010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.8014|TWO_SIDED|95.0|0.472|2.646|||Proportional odds regression model|||||2.646|0.472|0.8014
91580426|NCT01142115|183051011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.503||||0.3085|TWO_SIDED|95.0|0.314|39.106|||Regression, Logistic|||||39.106|0.314|0.3085
91580427|NCT01142115|183051012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.398||||0.4324|TWO_SIDED|95.0|0.606|3.225|||Proportional odds regression model|||||3.225|0.606|0.4324
91580428|NCT04828837|183051031|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|Mean Difference (Final Values)|0.39|||<|0.05|TWO_SIDED|95.0||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|Wilcoxon (Mann-Whitney)|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
91580429|NCT04828837|183051032|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
91580430|NCT04828837|183051033|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
91580431|NCT04828837|183051034|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
91580432|NCT01397422|183051035|SUPERIORITY||Least Squares Mean Difference|-11.3||||0.0051|TWO_SIDED|95.0|-19.1|-3.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.||-3.5|-19.1|0.0051
91580433|NCT01397422|183051035|SUPERIORITY||Least Squares Mean Difference|-10.0||||0.0131|TWO_SIDED|95.0|-17.8|-2.2|||ANCOVA|||||-2.2|-17.8|0.0131
91580434|NCT01397422|183051035|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.1595|TWO_SIDED|95.0|-13.4|2.2|||ANCOVA|||||2.2|-13.4|0.1595
91580435|NCT01397422|183051036|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.4314|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|||||0.5|-1.1|0.4314
91580436|NCT01397422|183051036|SUPERIORITY||Least Squares Mean Difference|0.3||||0.5223|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||||1.0|-0.5|0.5223
91580437|NCT01397422|183051036|SUPERIORITY||Least Squares Mean Difference|0.2||||0.6298|TWO_SIDED|95.0|-0.6|1.0|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, baseline value is a covariate||||1.0|-0.6|0.6298
91580438|NCT01397422|183051037|SUPERIORITY||Least Squares Mean Difference|-5.2||||0.0038|TWO_SIDED|95.0|-8.7|-1.7|||ANCOVA|||||-1.7|-8.7|0.0038
91580439|NCT01397422|183051037|SUPERIORITY||Least Squares Mean Difference|-6.4||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||||-2.9|-9.8|0.0004
91580440|NCT01397422|183051037|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.1469|TWO_SIDED|95.0|-6.0|0.9|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||||0.9|-6.0|0.1469
91580441|NCT01397422|183051038|SUPERIORITY||Least Squares Mean Difference|3.0||||0.0078|TWO_SIDED|95.0|0.8|5.2|||ANCOVA|||||5.2|0.8|0.0078
91580442|NCT01397422|183051038|SUPERIORITY||Least Squares Mean Difference|2.7||||0.0179|TWO_SIDED|95.0|0.5|5.0|||ANCOVA|||||5.0|0.5|0.0179
91580443|NCT01397422|183051038|SUPERIORITY||Least Squares Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.1|5.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||5.5|1.1|0.0040
91580444|NCT01397422|183051039|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.6355|TWO_SIDED|95.0|-11.2|6.9|||ANCOVA|||||6.9|-11.2|0.6355
91580445|NCT01397422|183051039|SUPERIORITY||Least Squares Mean Difference|1.7||||0.7053|TWO_SIDED|95.0|-7.2|10.6|||ANCOVA|||||10.6|-7.2|0.7053
91580446|NCT01397422|183051039|SUPERIORITY||Least Squares Mean Difference|1.2||||0.7862|TWO_SIDED|95.0|-7.7|10.1|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||10.1|-7.7|0.7862
91580447|NCT01397422|183051040|SUPERIORITY|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
91580448|NCT01397422|183051040|SUPERIORITY|||||||0.2158|||||||Cochran-Mantel-Haenszel|||||||0.2158
91580449|NCT01397422|183051040|SUPERIORITY|||||||0.1042|||||||Cochran-Mantel-Haenszel|Equally spaced scores||||||0.1042
91580450|NCT01846494|183051069|OTHER|||||||0.6173|||||||Log Rank|||||||0.6173
91580451|NCT01865747|183051090|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.||||0.74|0.45|<0.0001
91580452|NCT01865747|183051091|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.53|0.83|||Log Rank|The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.||||0.83|0.53|0.0003
91580453|NCT01865747|183051092|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
91580454|NCT00611975|183051098|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.8
91580455|NCT00611975|183051098|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.4
91580456|NCT00611975|183051099|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||Asex questionnaires were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for ASEX scores were re-assigned to phase based on time to onset of next menstrual period. Follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-2 days before NMP).||||>0.6
91580457|NCT00611975|183051099|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on ASEX scores||||>0.6
91580458|NCT00611975|183051100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||<.01
91580459|NCT00611975|183051100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<0.01
91580460|NCT00611975|183051101|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.4
91580461|NCT00611975|183051101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
91580462|NCT00611975|183051102|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.7
91580463|NCT00611975|183051102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
91580464|NCT00611975|183051103|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
91580465|NCT00611975|183051103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
91580466|NCT00611975|183051104|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
91580467|NCT00611975|183051104|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.9
91580468|NCT00611975|183051105|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.1|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.1
91580469|NCT00611975|183051105|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.7
91580470|NCT01982448|183051117|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|0.39|23.68|||||Association between HRD status and pathologic response was measured by the odds ratio (OR).|In the Cisplatin treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 52% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 5.7.||23.68|0.39|
91580471|NCT01982448|183051117|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.19|4.95||||||In the Paclitaxel treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 37% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 0.62.||4.95|0.19|
91580472|NCT01982448|183051118|SUPERIORITY||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.23|118.07||||||||118.07|0.23|
91580473|NCT01982448|183051118|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.09|4.14||||||||4.14|0.09|
91580474|NCT00715962|183051134|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test used as the rate of falling was low.||||||<.05
91580475|NCT00715962|183051135|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
91580476|NCT00266227|183051137|SUPERIORITY_OR_OTHER|||||||0.0195|||||||Cochran-Mantel-Haenszel|||||||0.0195
91580477|NCT00266227|183051139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||||95.0|-0.7|-0.1|||ANOVA|Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.||Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.||-0.1|-0.7|
91580478|NCT02716818|183051197|SUPERIORITY||Mean Difference (Final Values)|-0.069|||=|0.5521|TWO_SIDED|95.0|-0.299|0.161|||ANCOVA|||The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS profile for the natural logarithm of 17-OHP. The SDS profile was calculated as the SDS of log transformed 17-OHP concentration unsigned. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs, with the first and last (13th) weighted one half relative to the intermediate SDSs.||0.161|-0.299|=0.5521
91580479|NCT02716818|183051198|SUPERIORITY||Mean Difference (Final Values)|0.047|||=|0.7405|TWO_SIDED|95.0|-0.234|0.329|||ANCOVA|||Change from Baseline to 24 Weeks in A4 Using an ANCOVA Model - The analysis conducted for the primary endpoint variable analysis of 17-OHP was repeated for A4.||0.329|-0.234|=0.7405
91580480|NCT02716818|183051199|SUPERIORITY||Mean Difference (Final Values)|-0.037|||=|0.8186|TWO_SIDED|95.0|-0.354|0.281|||ANCOVA|||||0.281|-0.354|=0.8186
91580481|NCT02716818|183051199|SUPERIORITY||Mean Difference (Final Values)|-0.135|||=|0.4655|TWO_SIDED|95.0|-0.508|0.237|||ANCOVA|||||0.237|-0.508|=0.4655
91580482|NCT02716818|183051199|SUPERIORITY||Mean Difference (Final Values)|0.065|||=|0.9081|TWO_SIDED|95.0|-1.32|1.451|||ANCOVA|||||1.451|-1.32|=0.9081
91580483|NCT02716818|183051199|SUPERIORITY||Median Difference (Final Values)|0.092|||=|0.6729|TWO_SIDED|95.0|-0.343|0.527|||ANCOVA|||||0.527|-0.343|=0.6729
91580484|NCT02716818|183051199|SUPERIORITY||Mean Difference (Final Values)|0.116|||=|0.5322|TWO_SIDED|95.0|-0.257|0.489|||ANCOVA|||||0.489|-0.257|=0.5322
91580485|NCT02716818|183051199|SUPERIORITY||Mean Difference (Final Values)|-0.568|||=|0.2885|TWO_SIDED|95.0|-1.799|0.662|||ANCOVA|||||0.662|-1.799|=0.2885
91580486|NCT02716818|183051200|SUPERIORITY||Odds Ratio (OR)|0.99|||=|0.9877|TWO_SIDED|95.0|0.45|2.19|||Regression, Logistic|||||2.19|0.45|=0.9877
91580487|NCT02716818|183051200|SUPERIORITY||Odds Ratio (OR)|0.93|||=|0.8498|TWO_SIDED|95.0|0.43|2.02|||Regression, Logistic|||||2.02|0.43|=0.8498
91580488|NCT02716818|183051201|SUPERIORITY||Mean Difference (Final Values)|-0.96|||=|0.156|TWO_SIDED|95.0|-2.294|0.374|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||0.374|-2.294|=0.156
91580489|NCT02716818|183051201|SUPERIORITY||Median Difference (Final Values)|0.425|||=|0.3392|TWO_SIDED|95.0|-0.455|1.305|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||1.305|-0.455|=0.3392
91580490|NCT02716818|183051202|SUPERIORITY||Median Difference (Final Values)|0.009|||=|0.2614|TWO_SIDED|95.0|-0.007|0.025|||ANCOVA|||||0.025|-0.007|=0.2614
91580491|NCT02074553|183051233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|100.5|||||TWO_SIDED|90.0|93.14|108.44|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% confidence interval (CI).||108.44|93.14|
91580492|NCT02074553|183051233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.82|||||TWO_SIDED|90.0|90.71|105.48|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.48|90.71|
91580493|NCT02074553|183051233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.66|||||TWO_SIDED|90.0|80.32|93.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.5|80.32|
91580494|NCT02074553|183051233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.62|||||TWO_SIDED|90.0|85.15|92.24|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.24|85.15|
91580495|NCT02074553|183051233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.17|||||TWO_SIDED|90.0|77.08|83.39|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.39|77.08|
91580496|NCT02074553|183051233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|79.95|||||TWO_SIDED|90.0|76.84|83.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.19|76.84|
91580497|NCT02074553|183051234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|99.12|||||TWO_SIDED|90.0|91.83|106.99|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.99|91.83|
91580498|NCT02074553|183051234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.79|||||TWO_SIDED|90.0|86.94|101.17|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.17|86.94|
91580499|NCT02074553|183051234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.32|||||TWO_SIDED|90.0|74.41|86.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.7|74.41|
91580500|NCT02074553|183051234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.42|||||TWO_SIDED|90.0|83.92|91.07|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.07|83.92|
91580501|NCT02074553|183051234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.87|||||TWO_SIDED|90.0|75.76|82.11|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.11|75.76|
91580502|NCT02074553|183051234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.66|||||TWO_SIDED|90.0|75.53|81.92|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.92|75.53|
91580503|NCT02074553|183051235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.34|||||TWO_SIDED|90.0|82.33|99.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.12|82.33|
91580504|NCT02074553|183051235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.28|||||TWO_SIDED|90.0|60.45|72.68|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.68|60.45|
91580505|NCT02074553|183051235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|41.04|||||TWO_SIDED|90.0|37.4|45.03|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||45.03|37.40|
91580506|NCT02074553|183051235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.3|||||TWO_SIDED|90.0|81.77|91.09|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.09|81.77|
91580507|NCT02074553|183051235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.0|||||TWO_SIDED|90.0|73.01|81.2|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.20|73.01|
91580508|NCT02074553|183051235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.65|||||TWO_SIDED|90.0|71.71|79.82|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.82|71.71|
91580509|NCT02074553|183051237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.67|||||TWO_SIDED|90.0|82.34|102.05|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.05|82.34|
91580510|NCT02074553|183051237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.24|||||TWO_SIDED|90.0|60.44|74.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.79|60.44|
91580511|NCT02074553|183051237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|34.32|||||TWO_SIDED|90.0|30.83|38.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||38.21|30.83|
91580512|NCT02074553|183051237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.15|||||TWO_SIDED|90.0|89.1|101.62|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.62|89.10|
91580513|NCT02074553|183051237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|68.67|78.16|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.16|68.67|
91580514|NCT02074553|183051237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.76|||||TWO_SIDED|90.0|63.48|72.33|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.33|63.48|
91580515|NCT02074553|183051239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.77|||||TWO_SIDED|90.0|87.54|104.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||104.79|87.54|
91580516|NCT02074553|183051239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.69|||||TWO_SIDED|90.0|71.97|86.04|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.04|71.97|
91580517|NCT02074553|183051239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|53.91|||||TWO_SIDED|90.0|49.27|58.98|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||58.98|49.27|
91580518|NCT02074553|183051239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.16|||||TWO_SIDED|90.0|86.14|94.37|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.37|86.14|
91580519|NCT02074553|183051239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.76|||||TWO_SIDED|90.0|70.52|77.15|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.15|70.52|
91580520|NCT02074553|183051239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|70.94|||||TWO_SIDED|90.0|67.8|74.22|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.22|67.80|
91580521|NCT02074553|183051240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.05|||||TWO_SIDED|90.0|84.24|102.78|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.78|84.24|
91580522|NCT02074553|183051240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|74.35|||||TWO_SIDED|90.0|67.37|82.06|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.06|67.37|
91580523|NCT02074553|183051240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|43.94|||||TWO_SIDED|90.0|39.78|48.53|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||48.53|39.78|
91580524|NCT02074553|183051240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.21|||||TWO_SIDED|90.0|86.12|94.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.49|86.12|
91580525|NCT02074553|183051240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|72.72|||||TWO_SIDED|90.0|69.48|76.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||76.12|69.48|
91580526|NCT02074553|183051240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|69.34|||||TWO_SIDED|90.0|66.23|72.61|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.61|66.23|
91580527|NCT02074553|183051243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|98.79|||||TWO_SIDED|90.0|91.25|106.95|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.95|91.25|
91580528|NCT02074553|183051243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.58|||||TWO_SIDED|90.0|84.65|99.08|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.08|84.65|
91580529|NCT02074553|183051243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.41|||||TWO_SIDED|90.0|67.81|79.47|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.47|67.81|
91580530|NCT02074553|183051243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.81|||||TWO_SIDED|90.0|85.62|92.13|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.13|85.62|
91580531|NCT02074553|183051243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.74|||||TWO_SIDED|90.0|74.99|80.6|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||80.60|74.99|
91580532|NCT02074553|183051243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.65|||||TWO_SIDED|90.0|73.92|79.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.49|73.92|
91580533|NCT02074553|183051244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|89.41|||||TWO_SIDED|90.0|81.7|97.84|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||97.84|81.7|
91580534|NCT02074553|183051244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.84|||||TWO_SIDED|90.0|61.12|73.1|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.1|61.12|
91580535|NCT02074553|183051244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|42.32|||||TWO_SIDED|90.0|38.68|46.32|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||46.32|38.68|
91580536|NCT02074553|183051244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.76|||||TWO_SIDED|90.0|84.21|93.56|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.56|84.21|
91580537|NCT02074553|183051244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.82|||||TWO_SIDED|90.0|71.99|79.86|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.86|71.99|
91580538|NCT02074553|183051244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|69.53|77.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.19|69.53|
91580539|NCT02074553|183051245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.23|||||TWO_SIDED|90.0|89.85|105.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.21|89.85|
91580540|NCT02074553|183051245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.16|||||TWO_SIDED|90.0|80.59|94.26|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.26|80.59|
91580541|NCT02074553|183051245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.86|||||TWO_SIDED|90.0|62.71|73.43|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.43|62.71|
91580542|NCT02074553|183051245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.28|||||TWO_SIDED|90.0|85.06|91.63|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.63|85.06|
91580543|NCT02074553|183051245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.79|||||TWO_SIDED|90.0|74.03|79.65|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.65|74.03|
91580544|NCT02074553|183051245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.43|||||TWO_SIDED|90.0|72.7|78.27|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.27|72.70|
91580545|NCT02342743|183051254|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91580546|NCT02342743|183051255|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91580547|NCT02342743|183051256|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91580548|NCT02342743|183051257|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91580549|NCT02342743|183051258|SUPERIORITY|||||||0.012||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.012
91580550|NCT02342743|183051259|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
91580551|NCT02342743|183051261|SUPERIORITY|||||||0.03||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.030
91580552|NCT00686725|183051265|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||Log Rank|||||||0.183
91580553|NCT00686725|183051266|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Log Rank|||||||0.35
91580554|NCT00686725|183051269|SUPERIORITY_OR_OTHER|||||||0.648||95.0|||||Log Rank|||||||0.648
91580555|NCT00686725|183051270|SUPERIORITY_OR_OTHER|||||||0.915||95.0|||||Log Rank|||||||0.915
91580556|NCT00092495|183051278|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580557|NCT00092495|183051278|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580558|NCT00092495|183051279|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580559|NCT00092495|183051279|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580560|NCT00092495|183051280|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580561|NCT00092495|183051280|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580562|NCT00092495|183051280|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580563|NCT00092495|183051281|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580564|NCT00092495|183051281|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580565|NCT00092495|183051281|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580566|NCT00092495|183051282|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580567|NCT00092495|183051282|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580568|NCT00092495|183051283|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
91580569|NCT00092495|183051283|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
91580570|NCT00092495|183051284|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580571|NCT00092495|183051284|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580572|NCT00092495|183051284|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580573|NCT00092495|183051285|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580574|NCT00092495|183051285|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
91580575|NCT00092495|183051285|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580576|NCT00092495|183051286|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580577|NCT00092495|183051286|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580578|NCT00092495|183051287|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580579|NCT00092495|183051287|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580580|NCT00092495|183051288|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.01||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.01
91580581|NCT00092495|183051288|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580582|NCT00092495|183051288|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580583|NCT00092495|183051289|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580584|NCT00092495|183051289|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580585|NCT00092495|183051289|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580586|NCT00092495|183051290|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580587|NCT00092495|183051290|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580588|NCT00092495|183051291|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580589|NCT00092495|183051291|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580590|NCT00092495|183051292|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580591|NCT00092495|183051292|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580592|NCT00092495|183051292|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
91580593|NCT00092495|183051293|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580594|NCT00092495|183051293|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580595|NCT00092495|183051293|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
91580596|NCT00618618|183051302|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.2|-1.0|0.005
91580597|NCT00618618|183051302|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.4|-1.4|0.001
91580598|NCT00618618|183051302|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||0.0|-0.8|0.069
91580599|NCT00618618|183051303|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.005|TWO_SIDED|95.0|0.6|3.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||3.0|0.6|0.005
91580600|NCT00618618|183051303|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.001|TWO_SIDED|95.0|1.0|4.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.0|1.0|0.001
91580601|NCT00618618|183051303|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.122|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||2.2|-0.3|0.122
91580602|NCT00618618|183051304|SUPERIORITY_OR_OTHER||Difference from Placebo|38.3||||0.008|TWO_SIDED|95.0|11.0|65.7|||Fisher Exact|||||65.7|11.0|0.008
91580603|NCT00618618|183051304|SUPERIORITY_OR_OTHER||Difference from Placebo|32.9||||0.172|TWO_SIDED|95.0|1.0|64.8|||Fisher Exact|||||64.8|1.0|0.172
91580604|NCT00618618|183051304|SUPERIORITY_OR_OTHER||Difference from Placebo|22.9||||0.252|TWO_SIDED|95.0|-8.4|54.2|||Fisher Exact|||||54.2|-8.4|0.252
91580605|NCT00618618|183051305|SUPERIORITY_OR_OTHER||Difference from Placebo|46.1||||0.011|TWO_SIDED|95.0|16.3|75.9|||Fisher Exact|||||75.9|16.3|0.011
91580606|NCT00618618|183051305|SUPERIORITY_OR_OTHER||Difference from Placebo|54.3||||0.013|TWO_SIDED|95.0|23.0|85.5|||Fisher Exact|||||85.5|23.0|0.013
91580607|NCT00618618|183051305|SUPERIORITY_OR_OTHER||Difference from Placebo|24.3||||0.296|TWO_SIDED|95.0|-8.7|57.3|||Fisher Exact|||||57.3|-8.7|0.296
91580608|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.46|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.5|0.460
91580609|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.5|0.906
91580610|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.404|TWO_SIDED|95.0|-0.6|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.6|0.404
91580611|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.791|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.5|0.791
91580612|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.41|TWO_SIDED|95.0|-0.3|0.6|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|-0.3|0.410
91580613|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.733|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.3|0.733
91580614|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.542|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.3|0.542
91580615|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.882|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.4|0.882
91580616|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.4|-0.4|0.934
91580617|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.4|0.838
91580618|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.777|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.5|0.777
91580619|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.795|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.5|-0.4|0.795
91580620|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.852|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.4|0.852
91580621|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.444|TWO_SIDED|95.0|-0.6|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.3|-0.6|0.444
91580622|NCT00618618|183051306|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.724|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.3|0.724
91580623|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.4|0.934
91580624|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.286|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.7|0.286
91580625|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.1|0.7|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.7|-0.1|0.190
91580626|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.402|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.5|0.402
91580627|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.29|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.7|0.290
91580628|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.4|-0.4|0.863
91580629|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.128|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.1|-0.7|0.128
91580630|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.018|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||-0.1|-0.9|0.018
91580631|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.489|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.3|-0.5|0.489
91580632|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.007|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.1|-0.9|0.007
91580633|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.3|-0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.4|-1.3|<0.001
91580634|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.122|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.1|-0.7|0.122
91580635|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-0.9|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-0.9|0.005
91580636|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.3|-1.2|<0.001
91580637|NCT00618618|183051307|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.007|TWO_SIDED|95.0|-1.0|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-1.0|0.007
91580638|NCT00618618|183051309|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9||||0.573|TWO_SIDED|95.0|-8.6|4.8|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.8|-8.6|0.573
91580639|NCT00618618|183051309|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.653|TWO_SIDED|95.0|-6.3|9.9|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||9.9|-6.3|0.653
91580640|NCT00618618|183051309|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.688|TWO_SIDED|95.0|-5.4|8.1|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||8.1|-5.4|0.688
91580641|NCT01236365|183051317|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change in LDL-C between Atorvastatin and Placebo|Mixed Models Analysis|||||||<0.0001
91580642|NCT01236365|183051318|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||Change in hsCRP (6months minus 0months) between Atorvastatin and Placebo|Wilcoxon (Mann-Whitney)|||||||0.913
91580643|NCT01236365|183051321|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
91580644|NCT00955253|183051322|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||between the placebo and guanfacine conditions||||0.013
91580645|NCT00560560|183051326|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.|Test of probability of 6 month survival|p-Value \>0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.||The hypotheses for each group were H0:p=0.45 vs H1:p\>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.||||>0.05
91580646|NCT00006011|183051334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||"Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.~Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1."||1.17|0.69|
91580647|NCT02029872|183051366|OTHER|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.||||||||||||||||Due to low enrollment in the intervention, statistical analysis was not possible.|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.|||
91580648|NCT03699085|183051380|EQUIVALENCE|A p value of \< 0.05 suggests the groups are different.||||||0.38||||||A p value of \< 0.05 suggests the groups are different.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test is used, which ranks the values in each group, sums the ranks and determines the probability that they are the same. The probability p-value is reported.||||0.38
91580649|NCT03699085|183051381|SUPERIORITY|Adjusted mixed effects regression models were used to determine whether patients in the intervention and control group manifested different patterns of change in days of heroin use in the past 30 days in terms of incidence-rate ratio. We applied a negative binomial distribution to help account for overdispersion of outcome data.|Incidence rate ratio|1.29||||0.68|TWO_SIDED|95.0|0.38|4.37||A p value of \< 0.05 suggests the groups are different.|Regression, Cox||A number greater than 1.0 indicates a higher incidence rate of heroin use in past 30 days for intervention group compared to control group|Comparison of control and intervention populations based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use. This is a covariate-adjusted mixed effects regression model at TLFB timepoint of 6 months. A number greater than 1.0 indicates a higher incidence of heroin use in the past 30 days at the 6 month timepoint for intervention group compared to control group.||4.37|0.38|0.68
91580650|NCT00158860|183051388|SUPERIORITY||Kaplan-Meier estimates|27.3|||<|0.001|TWO_SIDED|95.0|16.0|38.6|||Log Rank|||||38.6|16.0|<0.001
91580651|NCT00158860|183051388|SUPERIORITY||Hazard Ratio (HR)|0.401|||<|0.001|TWO_SIDED|95.0|0.282|0.57|||Log Rank|||||0.570|0.282|<0.001
91580652|NCT00158860|183051389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|||||||<0.001
91580653|NCT00371683|183051420|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% confidence interval (CI) for the Relative Risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Ratio (RR)|1.02||||0.0635|TWO_SIDED|95.0|0.78|1.32||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||1.32|0.78|0.0635
91580654|NCT00371683|183051420|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Difference (RD)|0.11|||<|0.0001|TWO_SIDED|95.0|-2.22|2.44||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||2.44|-2.22|<0.0001
91580655|NCT00371683|183051421|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.7|2.23|||||If the upper bound of the two-sided 95% CI for the Relative Risk was \< 1 then superiority for the key secondary efficacy endpoint was demonstrated.|||2.23|0.70|
91580656|NCT00371683|183051421|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-0.68|1.4||||||||1.40|-0.68|
91580657|NCT00371683|183051421|SUPERIORITY_OR_OTHER|||||||0.7779|TWO_SIDED||||||t-test, 1 sided|||||||0.7779
91580658|NCT00371683|183051422|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||||1.35|0.80|
91580659|NCT00371683|183051422|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-2.04|2.59||||||||2.59|-2.04|
91580660|NCT00371683|183051422|SUPERIORITY_OR_OTHER|||||||0.7754|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7754
91580661|NCT00371683|183051423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.77|2.6||||||||2.60|0.77|
91580662|NCT00371683|183051423|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.53|||||TWO_SIDED|95.0|-0.47|1.52||||||||1.52|-0.47|
91580663|NCT00371683|183051423|SUPERIORITY_OR_OTHER|||||||0.2626|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2626
91580664|NCT00371683|183051424|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.63|1.87||||||||1.87|0.63|
91580665|NCT00371683|183051424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|-0.99|1.21||||||||1.21|-0.99|
91580666|NCT00371683|183051424|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7700
91580667|NCT00371683|183051425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.68|2.11||||||||2.11|0.68|
91580668|NCT00371683|183051425|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-0.78|1.33||||||||1.33|-0.78|
91580669|NCT00371683|183051425|SUPERIORITY_OR_OTHER|||||||0.5443|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||||||0.5443
91580670|NCT00371683|183051426|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.2|4.93||||||||4.93|0.20|
91580671|NCT00371683|183051426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||||0.30|-0.30|
91580672|NCT00371683|183051426|SUPERIORITY_OR_OTHER|||||||0.9975|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.9975
91580673|NCT00371683|183051427|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.05|0.3||||||||0.30|-0.05|
91580674|NCT00371683|183051427|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.1578
91580675|NCT00371683|183051428|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.65|2.4||||||||2.40|0.65|
91580676|NCT00371683|183051428|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.47|0.98||||||||0.98|-0.47|
91580677|NCT00371683|183051429|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.46|||||TWO_SIDED|95.0|0.72|2.95||||||||2.95|0.72|
91580678|NCT00371683|183051429|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-0.3|1.06||||||||1.06|-0.30|
91580679|NCT00371683|183051429|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2873
91580680|NCT00371683|183051430|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.74|1.2||||||||1.20|0.74|
91580681|NCT00371683|183051430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.83|||||TWO_SIDED|95.0|-3.3|1.63||||||||1.63|-3.30|
91580682|NCT00371683|183051430|SUPERIORITY_OR_OTHER|||||||0.6145|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.6145
91580683|NCT00371683|183051433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.55|0.05||||||Adjusted difference of event rates of MI/Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.55|
91580684|NCT00371683|183051433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19|||||TWO_SIDED|95.0|-0.46|0.09||||||Adjusted difference of event rates of MI. Type of surgery was taken into consideration as a stratification factor.||0.09|-0.46|
91580685|NCT00371683|183051433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
91580686|NCT00371683|183051433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of thrombocytopenia. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
91580687|NCT00371683|183051434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.81|||||TWO_SIDED|95.0|-1.49|-0.14||||||Adjusted difference of event rates of Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.14|-1.49|
91580688|NCT00371683|183051434|SUPERIORITY_OR_OTHER|||||||0.0533|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Major Bleeding Endpoint||||0.0533
91580689|NCT00371683|183051434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77|||||TWO_SIDED|95.0|-1.87|0.33||||||Adjusted difference of event rates of Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.33|-1.87|
91580690|NCT00371683|183051434|SUPERIORITY_OR_OTHER|||||||0.1709|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Clinically relevant Non-Major Bleeding endpoint||||0.1709
91580691|NCT00371683|183051434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.46|||||TWO_SIDED|95.0|-2.75|-0.17||||||Adjusted difference of event rates of Major or Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.17|-2.75|
91580692|NCT00371683|183051434|SUPERIORITY_OR_OTHER|||||||0.0338|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||Major or Clinically Relevant Non-Major Bleeding endpoint.||||0.0338
91580693|NCT00371683|183051434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.52|||||TWO_SIDED|95.0|-3.18|0.13||||||Adjusted difference of event rates of Any Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.13|-3.18|
91580694|NCT00371683|183051434|SUPERIORITY_OR_OTHER|||||||0.0816|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Any Bleeding Endpoint.||||0.0816
91580695|NCT03208036|183051449|SUPERIORITY||||||=|0.69|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .69
91580696|NCT03208036|183051449|SUPERIORITY||||||=|0.74|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .74
91580697|NCT03208036|183051450|SUPERIORITY||||||=|0.62|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .62
91580698|NCT03208036|183051450|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .24
91580699|NCT03208036|183051451|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
91580700|NCT03208036|183051451|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
91580701|NCT03208036|183051451|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
91580702|NCT03208036|183051451|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
91580703|NCT03208036|183051451|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
91580704|NCT03208036|183051451|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5 month assessment.||||= .46
91580705|NCT03208036|183051452|SUPERIORITY||||||=|0.68|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .68
91580706|NCT03208036|183051452|SUPERIORITY||||||=|0.45|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .45
91580707|NCT03208036|183051453|SUPERIORITY||||||=|0.81|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .81
91580708|NCT03208036|183051453|SUPERIORITY||||||=|0.31|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .31
91580709|NCT03208036|183051454|SUPERIORITY||||||=|0.79|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .79
91580710|NCT03208036|183051454|SUPERIORITY||||||=|0.5|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .50
91580711|NCT03208036|183051455|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
91580712|NCT03208036|183051455|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
91580713|NCT03208036|183051455|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
91580714|NCT03208036|183051455|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
91580715|NCT03208036|183051455|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
91580716|NCT03208036|183051455|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .46
91580717|NCT03208036|183051456|SUPERIORITY||||||=|0.99|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .99
91580718|NCT03208036|183051456|SUPERIORITY||||||=|0.84|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .84
91580719|NCT03208036|183051457|SUPERIORITY||||||=|0.25|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .25
91580720|NCT03208036|183051457|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
91580721|NCT03208036|183051457|SUPERIORITY||||||=|0.14|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .14
91580722|NCT03208036|183051457|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .02
91580723|NCT03208036|183051457|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .24
91580724|NCT03208036|183051457|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .93
91580725|NCT03208036|183051458|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .98
91580726|NCT03208036|183051458|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
91580727|NCT03208036|183051458|SUPERIORITY||||||=|0.08|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .08
91580728|NCT03208036|183051458|SUPERIORITY||||||=|0.06|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .06
91580729|NCT03208036|183051458|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .28
91580730|NCT03208036|183051458|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .23
91580731|NCT00350103|183051466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.041|TWO_SIDED|95.0|-0.88|-0.02|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||-0.02|-0.88|=0.0410
91580732|NCT00350103|183051466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||=|0.2902|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||0.20|-0.65|=0.2902
91580733|NCT02559895|183051512|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.4||0.0001|TWO_SIDED|95.0|-1.68|-0.54|||ANCOVA|||||-0.54|-1.68|0.0001
91580734|NCT02559895|183051512|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|3.4||0.0182|TWO_SIDED|95.0|-1.25|-0.12|||ANCOVA|||||-0.12|-1.25|0.0182
91580735|NCT02559895|183051512|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_DEVIATION|3.4||0.0046|TWO_SIDED|95.0|-1.39|-0.25|||ANCOVA|||||-0.25|-1.39|0.0046
91580736|NCT02559895|183051513|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.0007|TWO_SIDED|95.0|5.8|21.2|||Cochran-Mantel-Haenszel|||||21.2|5.8|0.0007
91580737|NCT02559895|183051513|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.1126|TWO_SIDED|95.0|-1.4|13.3|||Cochran-Mantel-Haenszel|||||13.3|-1.4|0.1126
91580738|NCT02559895|183051513|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.0272|TWO_SIDED|95.0|1.0|15.9|||Cochran-Mantel-Haenszel|||||15.9|1.0|0.0272
91580739|NCT02559895|183051514|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0066|TWO_SIDED|95.0|3.2|19.3|||Cochran-Mantel-Haenszel|||||19.3|3.2|0.0066
91580740|NCT02559895|183051514|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.0112|TWO_SIDED|95.0|2.4|18.6|||Cochran-Mantel-Haenszel|||||18.6|2.4|0.0112
91580741|NCT02559895|183051514|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.017|TWO_SIDED|95.0|1.8|17.8|||Cochran-Mantel-Haenszel|||||17.8|1.8|0.0170
91580742|NCT02559895|183051515|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.0001|TWO_SIDED|95.0|9.8|28.0|||Cochran-Mantel-Haenszel|||||28.0|9.8|0.0001
91580743|NCT02559895|183051515|SUPERIORITY||Mean Difference (Final Values)|12.4||||0.0085|TWO_SIDED|95.0|3.2|21.5|||Cochran-Mantel-Haenszel|||||21.5|3.2|0.0085
91580744|NCT02559895|183051515|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.0064|TWO_SIDED|95.0|3.7|22.0|||Cochran-Mantel-Haenszel|||||22.0|3.7|0.0064
91580745|NCT02559895|183051516|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|||||||0.0159
91580746|NCT02559895|183051516|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
91580747|NCT02559895|183051516|SUPERIORITY|||||||0.1539|||||||Cochran-Mantel-Haenszel|||||||0.1539
91580748|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.157||0.083||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glu/Cr posterior insula||||0.083
91580749|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.436||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr posterior insula||||0.436
91580750|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.306||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.306
91580751|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.809
91580752|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.116|STANDARD_DEVIATION|0.177||0.016|||||||t-test, 2 sided|Significance was set at p \<0.05.|Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.016
91580753|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.029|STANDARD_DEVIATION|0.308||0.708||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.708
91580754|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0||||Significance was set at p \<0.050.|t-test, 2 sided|||Glu/Cr anterior insula||||0.809
91580755|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr anterior insula||||0.154
91580756|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.960
91580757|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.937
91580758|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.897||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.897
91580759|NCT00760474|183051533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.309||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.309
91580760|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.032||||0.6347|TWO_SIDED|95.0|-0.1081|0.1714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Anterior Cingulate||0.1714|-0.1081|0.6347
91580761|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.079||||0.5181|TWO_SIDED|95.0|-0.3356|0.1771||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA22||0.1771|-0.3356|0.5181
91580762|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.072||||0.2987|TWO_SIDED|95.0|-0.2161|0.0714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA40||0.0714|-0.2161|0.2987
91580763|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.029||||0.5151|TWO_SIDED|95.0|-0.064|0.1219||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_anIns||0.1219|-0.0640|0.5151
91580764|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.2369|TWO_SIDED|95.0|-0.2228|0.0599||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Amygdala||0.0599|-0.2228|0.2369
91580765|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.077||||0.0758|TWO_SIDED|95.0|-0.1642|0.0092||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Cerebellum||0.0092|-0.1642|0.0758
91580766|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.025||||0.4609|TWO_SIDED|95.0|-0.0947|0.0452||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_DLPFC||0.0452|-0.0947|0.4609
91580767|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.111||||0.3813|TWO_SIDED|95.0|-0.3745|0.1524||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Insula||0.1524|-0.3745|0.3813
91580768|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.02||||0.72|TWO_SIDED|95.0|-0.0964|0.1361||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Temporal Pole||0.1361|-0.0964|0.7200
91580769|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.168||||0.2099|TWO_SIDED|95.0|-0.1065|0.4434||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Orbito Front||0.4434|-0.1065|0.2099
91580770|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.003||||0.9551|TWO_SIDED|95.0|-0.1047|0.0992||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||PAG||0.0992|-0.1047|0.9551
91580771|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.0855|0.0848||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Posterior Insula||0.0848|-0.0855|0.9940
91580772|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.049||||0.4291|TWO_SIDED|95.0|-0.1792|0.0806||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Posterior Cingulate||0.0806|-0.1792|0.4291
91580773|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.027||||0.467|TWO_SIDED|95.0|-0.0496|0.1028||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Precuneus||0.1028|-0.0496|0.4670
91580774|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.044||||0.4443|TWO_SIDED|95.0|-0.0752|0.1624||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Putamen||0.1624|-0.0752|0.4443
91580775|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.127||||0.2823|TWO_SIDED|95.0|-0.3704|0.1165||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_S2||0.1165|-0.3704|0.2823
91580776|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.105||||0.1369|TWO_SIDED|95.0|-0.2481|0.0378||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_DLPFC||0.0378|-0.2481|0.1369
91580777|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.078||||0.2376|TWO_SIDED|95.0|-0.0573|0.2127||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_anIns||0.2127|-0.0573|0.2376
91580778|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.153||||0.0968|TWO_SIDED|95.0|-0.3365|0.0313||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Amygdala||0.0313|-0.3365|0.0968
91580779|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.023||||0.572|TWO_SIDED|95.0|-0.061|0.1062||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_BA23\_base||0.1062|-0.0610|0.5720
91580780|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.027||||0.5822|TWO_SIDED|95.0|-0.1303|0.0761||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_IPL\_base||0.0761|-0.1303|0.5822
91580781|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.044||||0.6851|TWO_SIDED|95.0|-0.2697|0.1824||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Insula\_base||0.1824|-0.2697|0.6851
91580782|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.013||||0.8656|TWO_SIDED|95.0|-0.1699|0.1446||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Insula||0.1446|-0.1699|0.8656
91580783|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.094||||0.1562|TWO_SIDED|95.0|-0.2296|0.0407||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Front\_DLPFC||0.0407|-0.2296|0.1562
91580784|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.012||||0.7752|TWO_SIDED|95.0|-0.0991|0.0754||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Temporal Pole||0.0754|-0.0991|0.7752
91580785|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.01||||0.9182|TWO_SIDED|95.0|-0.1912|0.2109||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Orbito Front||0.2109|-0.1912|0.9182
91580786|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.022||||0.6544|TWO_SIDED|95.0|-0.0829|0.1278||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_PAG||0.1278|-0.0829|0.6544
91580787|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.087||||0.0813|TWO_SIDED|95.0|-0.0123|0.1863||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.1863|-0.0123|0.0813
91580788|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.052||||0.4605|TWO_SIDED|95.0|-0.0956|0.2004||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.2004|-0.0956|0.4605
91580789|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.3136|TWO_SIDED|95.0|-0.2484|0.0856||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Posterior Cingulate||0.0856|-0.2484|0.3136
91580790|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9929|TWO_SIDED|95.0|-0.0885|0.0893||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus||0.0893|-0.0885|0.9929
91580791|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.002||||0.949|TWO_SIDED|95.0|-0.0815|0.0767||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus\_base||0.0767|-0.0815|0.9490
91580792|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.065||||0.5668|TWO_SIDED|95.0|-0.3019|0.1722||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Superior Temporal||0.1722|-0.3019|0.5668
91580793|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9958|TWO_SIDED|95.0|-0.1398|0.1391||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Premotor||0.1391|-0.1398|0.9958
91580794|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.057||||0.3379|TWO_SIDED|95.0|-0.0659|0.1795||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Putamen||0.1795|-0.0659|0.3379
91580795|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.085||||0.2186|TWO_SIDED|95.0|-0.2262|0.0565||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_S1||0.0565|-0.2262|0.2186
91580796|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.008||||0.8191|TWO_SIDED|95.0|-0.0843|0.0678||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Thalamus||0.0678|-0.0843|0.8191
91580797|NCT00760474|183051534|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.012||||0.7647|TWO_SIDED|95.0|-0.0698|0.093||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Precuneus||0.0930|-0.0698|0.7647
91580798|NCT04664400|183051559|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.043|||||||t-test, 1 sided|||||||0.043
91580799|NCT04664400|183051560|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.036|||||||t-test, 1 sided|||||||0.036
91580800|NCT04664400|183051561|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.012|||||||t-test, 1 sided|||||||0.012
91580801|NCT04664400|183051562|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.835|||||||t-test, 1 sided|||||||0.835
91580802|NCT03762200|183051582|OTHER|Confidence Interval|percentage of sucesses|87.4|||||TWO_SIDED|95.0|79.4|93.1||||||||93.1|79.4|
91580803|NCT03762200|183051583|OTHER|Confidence Interval|Percentage of Successes|77.7|||||TWO_SIDED|95.0|68.4|85.3||||||||85.3|68.4|
91580804|NCT03762200|183051584|OTHER|Confidence Interval|Percentage of Successes|92.2|||||TWO_SIDED|95.0|85.3|96.6||||||||96.6|85.3|
91517804|NCT01106833|182910122|SUPERIORITY|||||||0.45||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.450
91518068|NCT02273141|182910400|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|2.95||||0.278|TWO_SIDED|95.0|-5.96|11.51||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.51|-5.96|0.278
91518069|NCT00529399|182910404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.98
91518070|NCT00529399|182910404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.51
91518071|NCT01506193|182910422|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.82|2.78||||||"Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1."||2.78|-1.82|
91518072|NCT01506193|182910422|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|1.29|||||TWO_SIDED|95.0|-3.04|6.67||||||"Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1."||6.67|-3.04|
91518073|NCT01506193|182910422|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.23|2.29||||||"Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1."||2.29|-1.23|
91518074|NCT01506193|182910422|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.33|||||TWO_SIDED|95.0|-1.87|2.03||||||"Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1."||2.03|-1.87|
91518075|NCT01506193|182910423|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be \[-10%\] or higher.|Difference in percentage|-1.02|||||TWO_SIDED|95.0|-3.39|2.24||||||"Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination."||2.24|-3.39|
91518076|NCT06242444|182910442|SUPERIORITY||Adjusted Mean Difference|8.35|STANDARD_ERROR_OF_MEAN|2.465||0.0012|TWO_SIDED|95.0|3.42|13.28|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||13.28|3.42|0.0012
91518077|NCT06242444|182910443|SUPERIORITY||Adjusted Mean Difference|37.33|STANDARD_ERROR_OF_MEAN|3.217|<|0.0001|TWO_SIDED|95.0|30.9|43.76|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||43.76|30.90|<.0001
91518078|NCT06242444|182910444|SUPERIORITY||Adjusted Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|2.462||0.1138|TWO_SIDED|95.0|-0.97|8.87|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.87|-0.97|0.1138
91518079|NCT06242444|182910446|SUPERIORITY||Adjusted Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|3.213||0.493|TWO_SIDED|95.0|-4.21|8.64|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.64|-4.21|0.4930
91518080|NCT06242444|182910450|SUPERIORITY||Adjusted Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.462||0.0789|TWO_SIDED|95.0|-0.52|9.32|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||9.32|-0.52|0.0789
91518081|NCT06242444|182910450|SUPERIORITY||Adjusted Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.408||0.2178|TWO_SIDED|95.0|-1.82|7.81|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||7.81|-1.82|0.2178
91518082|NCT06242444|182910451|SUPERIORITY||Adjusted Mean Difference|35.12|STANDARD_ERROR_OF_MEAN|3.213|<|0.0001|TWO_SIDED|95.0|28.69|41.54|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||41.54|28.69|<.0001
91518083|NCT06242444|182910451|SUPERIORITY||Adjusted Mean Difference|27.18|STANDARD_ERROR_OF_MEAN|3.018|<|0.0001|TWO_SIDED|95.0|21.14|33.21|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||33.21|21.14|<.0001
91518084|NCT06242444|182910452|SUPERIORITY||Geometric Mean Ratio|1.73|||<|0.0001|TWO_SIDED|95.0|1.53|1.97|||Mixed Models Analysis|||At 4 hours of intra-oral exposure||1.97|1.53|<.0001
